Every finding on record at Advanced Home Health Care Incorporated

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included names and contact information for staff, entities providing services under arrangement, patients' physicians, and other agencies. The findings include: test

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patients were provided the name of the administrator in order to receive complaints in 2 of 2 home visits conducted. (#1, #5) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Regulatory Compliance” revised April 2021, stated, “… The organization will maintain evidence of regulatory compliance, including but not limited to: … Federal regulations ….” 2. During an observation of care at the home of Patient #1, start of care 5/10/2021, on 1/25/2022 at 1:10 PM, the agency home folder was observed and evidenced the name of the administrator provided to the patient was governing body member E. 3. During an observation of care at the home of Patient #5, start of care 1/6/2022, on 1/28/2022 at 11:12 AM, the agency home folder was observed and evidenced the name of the administrator provided to the patient was governing body member E. 4. During an interview on 1/31/2022, at 10:12 AM, when asked why the agency home folder evidenced governing body member E as the administrator, the administrator stated, “Doesn’t surprise me.”

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the comprehensive assessment reflected the patient’s current status in 2 of 2 home visits. (#1, #5) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Initial and Comprehensive Assessment” revised April 2021, stated, “… During the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable: … A physical assessment, including …relevant data related to skin breakdown ….” 2. Clinical record review on 1/25/2022, for Patient #1, start of care 5/10/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, dated and digitally signed by Employee C, RN on 1/4/2022. The document evidenced the patient had pitting edema (excess fluid built up in the body and when pressure is applied, causes an indentation) to the right and left foot. The comprehensive assessment failed to indicate the degree of pitting to the right and left feet. The document indicated the patient had dialysis (a process in which excess water and toxins are removed from the blood in people whose kidneys no longer perform these functions naturally) and failed to evidence the type of dialysis access device and where the patient received dialysis. Review of a document obtained on 1/25/2022, from dialysis center A titled “Diet Order”, dated 12/29/2020, and electronically signed by clinical nurse specialist (CNS) B on 3/25/2021, indicated the patient had a fluid restriction of 1000 ml (milliliters) a day. The fluid restriction failed to be included in the comprehensive assessment. During an interview on 1/27/2022, at 12:22 PM, the clinical manager indicated the comprehensive assessment should have been completed to indicate the degree of pitting edema from 1+ to 4+ pitting edema. The clinical manager indicated the comprehensive assessment should be complete to include the type of dialysis access device and location of dialysis. The clinical manager indicated if the patient had a fluid restriction, it should be included in the comprehensive assessment. During an interview on 1/27/2022, at 12:23 PM, the administrator indicated the patient had a central line for dialysis access. 3. Clinical record review on 1/28/2022, for Patient #5, start of care 1/6/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, digitally signed by Employee C and dated 1/6/2022. This document indicated the patient’s primary diagnosis was the removal/change of a surgical wound dressing and failed to evidence the assessment of a surgical wound. The document indicated the patient had a traumatic wound to the left lower back quadrant. This document indicated the patient had a nephrostomy (a passageway surgically created between the skin and the kidney) and failed to indicate where the nephrostomy was located. This document indicated the patient had pitting edema to both thighs and the nurse measured both thighs. The document failed to evidence the degree of pitting edema and evidenced the measurements were obtained by the RN. During an interview on 1/31/2022, at 11:00 AM, the administrator indicated she was unsure what the traumatic wound assessment was for the left lower back quadrant. The administrator indicated maybe it was the assessment of the nephrostomy and indicated the wound diagnosis should match. The administrator indicated the comprehensive document should be complete to include the location of the nephrostomy. At 11:14 AM, the administrator indicated comprehensive assessment should include the assessment of the degree of the pitting edema to the thighs. During an observation of care at the home of patient #5, start of care 1/6/2022, on 1/28/2022, at 10:28 AM, RN C was observed measuring the patient’s legs above the knee. Employee C indicated the right thigh measured 21 inches and the left thigh measured 18 inches. Employee C was observed removing the socks to both feet. The patient’s right foot was observed to be swollen compared to the left foot. Employee C was observed raising the patient’s pants to the knees on both legs and applying lotion to both lower legs. The right lower leg between the knee and the ankle was observed to be swollen compared to the left lower leg. The skilled nurse was not observed to have palpated the lower legs and feet to determine the degree of edema. At 10:40 AM, Employee C assisted the patient to a standing position using the walker. A dressing was noted to the patient’s right buttock with a date of 1/27/2022 observed written on the dressing. Employee C was observed removing the dressing and brown drainage was observed on the dressing. The area on the right buttock was observed to be open with a pink base the size of a pencil eraser. Employee C indicated she would document the wound as a Stage 1 (a pressure wound that is not open) and instructed the patient’s spouse to apply zinc (a topical wound ointment) to the area. Employee C was not observed to measure the wound to the right buttock. Review of an agency document on 1/31/2022, titled “OASIS-D1 Resumption of Care”, digitally signed by Employee C and dated 1/28/2022, indicated the patient had a surgical wound to the left lower back quadrant, a surgical wound to the right lower back, a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) Stage 1 to the right mid-back, and a deep tissue injury to the left heel. The comprehensive assessment failed to include the wound which was observed to the right buttock. This document indicated the patient was assessed to have pitting edema to measure 23 inches in the right thigh above the knee and 19 inches in the left thigh above the knee. This document failed to indicate Employee C completed the assessment, including the degree of pitting edema. This document failed to accurately document the measurements of the right and left thighs above the knee. The comprehensive assessment failed to evidence the completion of the mobility assessment for the Braden Scale Assessment (an assessment tool used to determine the risk of developing pressure ulcers). During an interview on 1/31/2022, at 10:19 AM, the administrator indicated the wound assessment should include the measurement. At 10:31 AM, the administrator indicated the score for mobility should have been completed for the Braden Scale. At 10:36 AM, the administrator indicated all wounds should be assessed and was unsure why the area to the right mid-back was documented as a wound. At 10:52 AM, the administrator indicated there was no assessment for the wound to the right buttock. During an interview on 1/31/2022, at 10:24 AM, the clinical manager indicated the nurse should touch the area of swelling to check for pitting edema and to what degree from 1+ to 4+. 410 IAC 17-14-1(a)(1)(B)

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included the patient’s primary caregiver and other available support, including their willingness and ability to provide care in 2 of 5 clinical records reviewed. (#3, #4) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Initial and Comprehensive Assessment” revised April 2021, stated, “… During initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable: … Patient and family/caregiver and other available support systems and the type of care family/caregiver is available, capable, and willing to provide….” 2. Clinical record review on 1/26/2022, for Patient #3, start of care 10/10/2020, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, digitally signed and dated by the administrator on 12/3/2021. This document indicated the patient’s primary diagnosis was diabetes (a chronic condition that affects the way the body processes blood sugar). This document evidenced the patient had a diabetic ulcer (wounds commonly found on the feet of people with uncontrolled blood sugar, which damages nerves and blood vessels, making wound healing difficult) to the left heel. This assessment indicated the patient was chairbound and required assistance for grooming, dressing, transferring, bathing, and toileting. This document indicated the patient required insulin (an injectable medication used to treat high blood sugar) and was unable to take injectable medication unless administered by another person. This document stated, “… She has no one at home that can assist in wound care….” During an interview on 1/26/2022 at 1:18 PM, Employee F, RN indicated the patient lived with a roommate, but the roommate was unable to care for the patient’s wound due to the roommate was an amputee and required dialysis (a process in which excess water and toxins are removed from the blood in people whose kidneys no longer perform these functions naturally) treatment. During an interview on 1/27/2022 at 2:20 PM, when queried who was the patient’s primary caregiver, the administrator indicated she would check. The administrator indicated the primary caregiver should be determined. No further documentation or information was provided. 3. Clinical record review on 1/26/2022, for Patient #4, start of care 12/30/2021, evidenced an agency document titled “OASIS-D1 Start of Care”, digitally signed by Employee F and dated 12/20/2021. This document indicated the patient’s diagnoses included, but was not limited to, chronic obstructive pulmonary disease (a condition involving constriction of the airway causing difficulty or discomfort in breathing), lung cancer, and diabetes. This document indicated the patient required supplemental oxygen at all times. The assessment indicated the patient was dependent on another for grooming, dressing, and toileting and required assistance for bathing, transferring, and ambulation. This assessment evidenced the patient was unable to take medication unless administered by another person. This document indicated the patient lived with another person in the home and indicated family/friends provided assistance with activities of daily living (ADLs). This document evidenced caregivers needed training/supportive services to provide assistance. The comprehensive assessment failed to identify the primary caregiver. During an interview on 1/27/2022, at 4:53 PM, the administrator indicated she did not know who the patient’s primary caregiver was.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated and revised to include a new wound in 1 of 2 active clinical records reviewed with wounds. (#1) The findings include: Review of an agency policy on 1/31/2022, titled “Reassessments/Recertification” revised April 2021, stated, “… Each patient will be reassessed using a comprehensive OASIS [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] assessment tool for the review and revision of the plan of care when: … There is a significant change in the patient’s condition ….” Clinical record review on 1/25/2022, for Patient #1, start of care 5/10/2021, evidenced an agency document titled “Physician Order”, digitally signed and dated by the administrator on 12/7/2021. This document indicated the wound to the right shin was healed and treatment was discontinued. Review of an agency document titled “Wound Care Worksheet”, digitally signed and dated by Employee C, RN and dated 12/28/2021, evidenced a traumatic wound to the right shin with an onset date of 12/28/2021. A review of this document failed to evidence a wound assessment to the right shin and failed to evidence the comprehensive assessment was updated and revised to include the wound to the right shin as documented with an onset date of 12/28/2021. During an interview on 1/27/2022, at 12:12 PM, the clinical manager indicated the RN should have updated and revised the comprehensive assessment to include the decline in the patient’s condition related to the patient’s wound to the right shin. The clinical manager indicated a wound was considered a decline in patient’s status warranting an update to the comprehensive assessment. 410 IAC 17-14-1(a)(1)(B)

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all necessary medical information pertaining to the patient’s current course of illness and treatment was sent to the receiving health care practitioner to ensure the safe and effective transition of care in 1 of 2 closed records reviewed (#3) and in 1 of 1 active clinical record reviewed with a transfer (#5). The findings include: 1. Review of an agency policy on 1/31/2022, titled “Discharge Summary” revised April 2021, stated, “… A copy of the discharge summary and any necessary medical information will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization ….” 2. Review of an agency policy on 1/31/2022, titled “Transfer Summary” revised April 2022, stated “… Within 48 hours of transfer, the transferring clinician will complete a transfer summary that includes, as appropriate: … The physical and psychosocial status at the time of transfer, including specific medical, psychosocial, or other problems requiring interventions or follow-up …. Completed transfer summaries will be given to a clinical records clerk, who will send a copy to the receiving organization …within two (2) business days of a planned transfer or within two (2) days of becoming aware of an unplanned transfer ….” 3. Clinical record review on 1/26/2022, for Patient #3, start of care 10/10/2020, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Discharge”, digitally signed by registered nurse (RN) F and dated 1/21/2022. This document indicated the patient had a diabetic ulcer (wounds commonly found on the feet of people with uncontrolled blood sugar, which damages nerves and blood vessels, making wound healing difficult) to the left heel requiring dressing changes 3 times a week. This document indicated the patient had a diagnosis of diabetes (a chronic condition that affects the way the body processes blood sugar) and required insulin (an injectable medication used to treat high blood sugar). This document indicated the patient was chairfast and required assistance with grooming, dressing, bathing, transferring, and toilet hygiene. This document indicated caregivers were not likely or it was unclear if they would provide assistance with medical treatments to include wound care. This document stated, “… patient was relocating to an area outside of home care area. Educated on the need to obtain home care for wound care ….” Review of this document failed to evidence the RN conferenced with the receiving healthcare provider responsible for providing care and services. A review of an agency document titled “Discharge Summary”, digitally signed by Employee F, RN and dated 1/21/2022, indicated the patient’s status at discharge was the patient needed assistance. This document indicated all goals were not met and the patient needed ongoing home care for wound care in her new area. A review of this document failed to evidence the agency conferenced with the receiving healthcare provider responsible for providing care and services. During an interview on 1/26/2022, at 1:18 PM, Employee F indicated the patient moved more than an hour away and indicated the patient informed RN F the patient would get established with a new physician where she was moving. Employee F indicated she did not inform the receiving healthcare provider of the care and treatment required by the patient because she did not know who the new physician was. During an interview on 1/27/2022, at 2:12 PM, the administrator indicated there was no information provided to the physician assuming care of the patient. The administrator stated, “I guess that falls on me. It’s ultimately my responsibility.” 4. Clinical record review on 1/28/2022, for Patient #5, start of care 1/6/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, digitally signed by Employee C, RN and dated 1/6/2022. This document indicated the patient’s primary diagnosis was the removal/change of a surgical wound dressing and indicated the patient had a traumatic wound to the left lower back quadrant. This document indicated the patient had a nephrostomy (a passageway surgically created between the skin and the kidney). Review evidenced an agency document titled “Transfer Summary”, digitally signed by the administrator and dated 1/14/2022. This document indicated the patient was transferred to Hospital E on 1/14/2022. This document failed to include information regarding the patient’s nephrostomy and wound care required. This document evidenced handwriting at the bottom of the document which stated, “Copy sent to [physician] 1/14/2022 …” and evidenced the administrator’s initials. A review of this document failed to evidence the transfer summary was sent to Hospital E. A review of an agency document on 1/31/2022, titled “Task Details” evidenced the transfer summary was not completed in the electronic health record until 1/22/2022 by the administrator. During an interview on 1/31/2022, at 10:31 AM, when queried how the transfer summary was sent to the physician on 1/14/2022 when the document was not completed until 1/22/2022, the administrator stated, “No comment.” The administrator indicated there was no documentation the transfer summary was sent to the hospital. At 10:56 AM, the administrator indicated the transfer summary should probably include information regarding the patient’s nephrostomy and wound care.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was reviewed by the physician responsible for the plan of care at least every 60 days in 3 of 5 clinical records reviewed. (#1, #2, #3) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Physician Participation in Plan of Care” revised April 2021, stated, “… The attending physician (or other authorized licensed independent practitioner) will sign the plan of care/treatment within 30 days of the start of care. … The attending physician’s (or other authorized licensed independent practitioner) recertification will be obtained in intervals of at least every 60 days when the patient’s plan of care is reviewed, the patient recertified, and more often, if warranted….” 2. Clinical record review on 1/25/2022, for Patient #1, start of care 5/10/2021, evidenced agency documents titled “Home Health Certification and Plan of Care”. The document for the certification period 9/7/2021 – 11/5/2021, was signed by the physician on 9/15/2021. A review of the document for the certification period 11/6/2021 – 1/4/2022, was signed by the physician on 1/10/2022. The plan of care failed to evidence to be reviewed by the physician at least every 60 days. 3. Clinical record review on 1/26/2022, for Patient #2, start of care 6/25/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 10/23/2021 – 12/21/2021, which was signed by the physician on 11/16/2021. A review of an agency document titled “Home Health Certification and Plan of Care” for the certification period 12/22/2021 – 2/19/2022, was signed by the physician on 1/26/2022. The plan of care failed to evidence to be reviewed by the physician at least every 60 days. During an interview on 1/27/2022, at 1:30 PM, the clinical manager indicated the current plan of care should have been sent out before yesterday. 4. Clinical record review on 1/26/2022, for Patient #3, start of care 10/10/2020, evidenced agency documents titled “Home Health Certification and Plan of Care”. The document for the certification period 10/5/2021 – 12/3/2021, was signed by the physician on 10/23/2021. The document for certification period 12/4/2021 – 2/1/2022, failed to evidence to be signed by the physician. The plan of care failed to evidence to be reviewed by the physician at least every 60 days. During an interview on 1/27/2022, at 1:58 PM, the administrator indicated the current plan of care was not returned signed by the physician yet. When queried when the plan of care was sent to the physician, the administrator indicated it was faxed on 1/26/2022. The administrator indicated it was sent to the physician late and stated, “I’ve been so busy, so this is probably not a chart I’ve gotten to yet.” 5. During an interview on 1/27/2022, at 12:17 PM, the clinical manager indicated the plan of care is sent to the physician as soon as it is completed by the registered nurse and reviewed by the office, which was usually within 10 days. The clinical manager indicated the physician should review the plan of care every 60 days. 41- IAC 17-13-1(a)(2)

Discharge plans communication CFR(s): 484.60(c)(3)(ii) (ii) Any revisions related to plans for the patient's discharge must be communicated to the patient, representative, caregiver, all physicians or allowed practitioner's issuing orders for the HHA plan of care, and the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any). This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure revisions to the plans for patient discharge was communicated to the physician responsible for the plan of care in 1 of 1 closed record reviewed for discharge not at the patient’s request. (#2) The findings include: A review of an agency policy on 1/31/2022, titled “Discharge Criteria and Process” revised April 2021, stated, “… When the patient’s plan of care changes and this change results in discharge or reduction of services, the patient or his/her representative, as well as his/her primary physician (or other authorized licensed independent practitioner), will be notified and involved in planning decisions….” Clinical record review on 1/26/2022, for Patient #2, start of care 6/25/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/22/2021 – 2/19/2022, which was signed by the physician on 1/26/2022. This document indicated the patient’s primary diagnosis was a pressure ulcer (a wound to the skin and underlying tissue resulting from prolonged pressure to the skin) to the right heel. This document indicated the skilled nurse was to provide services 1 time a week for 9 weeks and indicated the estimated discharge date was 2/20/2022. Review of an agency document titled “RN [registered nurse] – Skilled Nursing Visit”, digitally signed and dated by Employee C, RN on 1/17/2022, indicated the patient was to be discharged in 1 week if the wound was healed and discharged was scheduled for 1/24/2022. Review failed to evidence the physician was notified of the change in plans for patient discharge. During an interview on 1/27/2022, at 1:39 PM, the administrator indicated there was no physician communication related to the change in discharge plans for the patient prior to 1/24/2022.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the caregiver received education and training provided by the agency regarding the care and services identified in the plan of care for 2 of 5 clinical records reviewed. (#3, #4) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Discharge Criteria and Process” revised April 2021, stated, “… For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs after the organization services are discontinued. Discharge instructions will be provided. … Arrangements for such services will be coordinated by the organization when applicable….” 2. Clinical record review on 1/26/2022, for Patient #3, start of care 10/10/2020, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Discharge”, digitally signed by Employee F, RN, and dated 1/21/2022. This document indicated the patient had a diabetic ulcer (wounds commonly found on the feet of people with uncontrolled blood sugar, which damages nerves and blood vessels, making wound healing difficult) to the left heel requiring dressing changes 3 times a week. This document indicated the patient had a diagnosis of diabetes (a chronic condition that affects the way the body processes blood sugar) and required insulin (an injectable medication used to treat high blood sugar). This document indicated the patient was chairfast and required assistance with grooming, dressing, bathing, transferring, and toilet hygiene. This document indicated caregivers were not likely or it was unclear if they would provide assistance with medical treatments to include wound care. This document stated, “… patient was relocating to an area outside of home care area. Educated on the need to obtain a home care for wound care ….” A review of an agency document titled “Discharge Summary”, digitally signed by Employee F and dated 1/21/2022, indicated the patient’s status at discharge was the patient needed assistance. This document indicated all goals were not met and the patient needed ongoing home care for wound care in her new area. During an interview on 1/26/2022, at 1:18 PM, Employee F indicated the patient moved more than an hour away and indicated she was unsure which family member the patient was moving in with. Employee F indicated the patient was not capable of providing wound care. Employee F indicated she did not speak to the family member the patient was moving in with to ensure the caregiver knew of the care and treatment required and indicated maybe she should have. During an interview on 1/27/2022, at 2:12 PM, the administrator indicated she believed the patient moved in with her daughter and she had no idea if the daughter was trained in wound care and the diabetic care the patient required. The administrator indicated the agency should communicate to the assuming caregiver to ensure the caregiver was informed of and was willing to provide patient care. The administrator stated, “I guess that falls on me. It’s ultimately my responsibility.” 3. Clinical record review on 1/26/2022, for Patient #4, start of care 12/30/2021, evidenced an agency document titled “OASIS-D1 Start of Care”, digitally signed by RN F and dated 12/20/2021. This document indicated the patient’s diagnoses included, but was not limited to, chronic obstructive pulmonary disease (a condition involving constriction of the airway causing difficulty or discomfort in breathing), lung cancer, and diabetes. This document indicated the patient required supplemental oxygen at all times. The assessment indicated the patient was dependent on another for grooming, dressing, and toileting and required assistance for bathing, transferring, and ambulation. This assessment evidenced the patient was unable to take medication unless administered by another person. This document indicated the patient lived with another person in the home and family/friends provided assistance with activities of daily living (ADLs). This document evidenced caregivers needed training/supportive services to provide assistance. Review failed to evidence the caregivers were provided education on the care required. During an interview on 1/27/2022, at 4:53 PM, the administrator indicated she did not know who the patient’s primary caregiver was and did not know what education was provided to the caregiver. 410 IAC 17-14-1(a)(1)(G)

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide the patient and caregiver in writing a copy of treatments to be administered by the agency in 2 of 2 home visits conducted. (#1, #5) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Care Planning Process” revised April 2021, stated, “… The organization shall provide the patient and caregiver with a copy of written instructions outlining: … Any treatments to be administered by the organization’s personnel ….” 2. Clinical record review on 1/25/2022, for Patient #1, start of care 5/10/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, dated and digitally signed by registered nurse (RN) C on 1/4/2022. This document indicated the patient had pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the left and right heels, a traumatic wound to the right shin, and a surgical wound to the abdomen for the suprapubic catheter (a plastic tube surgically inserted through the abdomen and into the bladder to drain urine). This document indicated the wound treatment to the right and left heels was to cleanse with normal saline (a solution used to cleanse wounds), apply xeroform (a fine mesh gauze containing petroleum so as not to adhere to the wound bed) gauze, and apply a dry dressing. This document indicated the treatment to the right shin was to cleanse with normal saline, apply antibiotic ointment and a dry dressing if drainage noted. This document indicated the treatment to the suprapubic catheter site was cleansed with normal saline and applied a dry split gauze. This document indicated the suprapubic catheter was to be changed every 4-6 weeks. Review of a clinical document titled “SNV [skilled nurse visit] w/ [with] Aide Supervision]” dated 1/18/2022, and a clinical document titled “RN – Skilled Visit Note”, dated 1/25/2022, and both signed by Employee C, RN indicated the skilled nurse provided wound care to the left heel, right heel, right shin, and suprapubic catheter. Review indicated the RN changed the suprapubic catheter on 1/18/2022. During an observation of care at the patient’s home on 1/25/2022, at 1:10 PM, the agency home folder was observed and failed to evidence the written instructions of treatments to be administered by the agency. 3. Clinical record review on 1/28/2022, for Patient #5, start of care 1/6/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, digitally signed by Employee C and dated 1/6/2022. This document indicated the patient had an open traumatic wound to the left lower back quadrant This document indicated the wound treatment was to cleanse with normal saline and apply a dry dressing. This document indicated the patient had a nephrostomy (a passageway surgically created between the skin and the kidney). During an observation of care at the patient’s home on 1/28/2022, at 10:05 AM, the patient was observed to have a nephrostomy tube (a clear plastic tube inserted into the nephrostomy site to drain urine from the body) attached to drainage bag on the left mid-back and on the right mid-back. The patient was observed to have a wound to the left heel with a dressing in place and was observed with a wound to the right buttock. Employee C was observed providing wound treatment to the nephrostomy sites on the left and right mid-back and to the left heel. At 11:12 AM, the agency home folder was observed and evidenced the treatment plan for patient #6 within the folder. Review failed to evidence the written instructions of treatments for the patient to be administered by the agency. 4. During an interview on 1/31/2022, at 10:14 AM, the administrator indicated the nurse is to take a plan of care to the patient in the agency home folder and indicated the nurse is to check for it at every visit and replace if needed.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on record review and interview, the skilled professional failed to ensure the following: failed to develop and evaluate the plan of care (See tag G0708); failed to provide the services as indicated in the plan of care (See tag G0710); failed to provide the patient and caregiver education (See tag G0714); and failed to prepare clinical notes (See tag G0716). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.75 Skilled Professional Services.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the registered nurse failed to provide services as directed in the plan of care in 3 of 4 clinical records reviewed with wounds. (#1, #2, #5) The findings include 1. Review of an agency policy on 1/31/2022, titled “Scope of Services” revised April 2021, stated, “… Professional nursing services are provided in accordance with the patient’s plan of care, under the supervision of a registered nurse ….” 2. Clinical record review on 1/25/2022, for Patient #1, start of care 5/10/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/5/2022 – 3/5/2022, which was unsigned by the Employee C, RN, and physician. The plan of care indicated the skilled nurse was to change the suprapubic catheter (a plastic tube surgically inserted through the abdomen and into the bladder to drain urine) every 4-6 weeks using a 20 French (Fr) (the unit of measure for the diameter of a catheter, a plastic tube inserted into the body) and the balloon inflated with 10 milliliters (ml). Review of an agency document titled “SNV [skilled nurse visit] w/ [with] Aide Supervision]” dated and electronically signed by Employee C on 1/18/2022, indicated the skilled nurse changed the suprapubic catheter. This document stated, “… patient had some discomfort when balloon inflated to 15cc [cubic centimeter and equal to milliliters]….” The document failed to evidence the skilled nurse followed the plan of care and inflated the balloon to 10 ml. During an interview on 1/27/2022, at 12:05 PM, the clinical manager indicated the catheter balloon should not be over-inflated because it can cause misshaping of the balloon. 3. Clinical record review on 1/26/2022, for Patient #2, start of care 6/25/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/22/2021 – 2/19/2022, which was signed by the physician on 1/26/2022. This document indicated the skilled nurse was to perform a head-to-toe assessment to include the gastrointestinal (the digestive system) status. Review evidenced agency document titled “RN – Skilled Nursing Visit”, digitally signed and dated by Employee C on 12/27/2021. This document indicated the patient’s last bowel movement was 12/26/2021 and indicated the patient was constipated. The document failed to evidence the RN assessed the patient’s abdomen to include distention and tenderness. During an interview on 1/27/2022, at 1:37 PM, the clinical manager indicated the assessment should include palpation of the abdomen to determine abdominal distention and tenderness. 4. Clinical record review on 1/28/2022, for Patient #5, start of care 1/6/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/6/2022 – 3/6/2022, which was signed and dated by the physician on 1/24/2022. This document indicated the physician was to be notified for a diastolic blood pressure (the pressure against the arteries when the heart is at rest, indicated by the bottom number) of less than 60. This document indicated the nurse was to provide wound care to the left lower back wound at every visit. A review of an agency document titled “RN – Skilled Nursing Visit”, digitally signed and dated by Employee C on 1/12/2022, evidenced the diastolic blood pressure to the left arm was 58. The document failed to evidence the RN notified the physician as directed in the plan of care. This document indicated the wound to the left lower back was open but indicated it was not addressed at this visit. Review failed to evidence the nurse provided wound care as directed in the plan of care. During an interview on 1/31/2022, at 11:05 AM, the administrator indicated she did not see the RN notified the physician of the diastolic blood pressure. When queried at 11:07 AM why the nurse did not provide wound care per the plan of care, the administrator stated, “I have no idea.” A review of an agency document on 1/31/2022, titled “Physician Order”, digitally signed by the administrator and dated 1/28/2022, stated, “Post Hospitalization: Resume skilled nurse … continue all services and treatments per plan of care dated 1/6/22 to 3/6/22 ….” Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/6/2022 – 3/6/2022, signed and dated by the physician on 1/24/2022. This document indicated the skilled nurse was to perform a head-to-toe assessment to include gastrointestinal status. During an observation of care on 1/28/2022, at 10:49 AM, Employee C was observed completing skilled patient care, and Employee C was not observed to have assessed the patient’s bowel sounds and any abdominal distention. During an interview on 1/31/2022, at 10:17 AM, the clinical manager indicated the skilled nurse’s gastrointestinal assessment should include palpating (to examine a patient by feeling with hands or fingers) the patient’s abdomen for distention and auscultating (to examine a patient by listening, typically done with a stethoscope) the abdomen for bowel sounds. 410 IAC 17-14-1(a)(1)(H)

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to provide written instructions for patient care by the home health aide (HHA) which followed the patient’s plan of care in 1 of 1 clinical record reviewed with home health aide services. (#1) The findings include: Review of an agency policy on 1/31/2022, titled “Orientation of Assigned Home Health Aide” revised April 2021, stated, “… The nurse or therapist will be responsible for the initial assessment and assignment of the home health aide. … The home health aide assignment sheet correlates with the orders on the plan of care (485)….” Clinical record review for Patient #1 on 1/25/2022, start of care 5/10/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/5/2022 – 3/5/2022, which indicated the patient was to receive HHA services 1 time a week for 8 weeks to include assist with bathing and personal hygiene. The plan of care indicated the patient’s individualized diastolic blood pressure (the pressure against the walls of the arteries when the heart is at rest, indicated by the bottom number) parameter was between 60-90. A review of an agency document titled “Aide Care Plan” signed by Employee C, RN and dated 9/8/2021, indicated the RN assigned the HHA to obtain vital signs to include blood pressure, pulse, respiration, and temperature at every visit. The document indicated the patient’s blood pressure The document indicated the patient’s diastolic blood pressure parameter was 58-90. The RN failed to assign the HHA tasks which followed the orders on the plan of care. During an interview on 1/27/2022, at 11:40 AM, the administrator indicated the RN should assign the HHA tasks on the HHA care plan that were ordered in the patient’s plan of care. At 12:38 PM, the administrator indicated there was no HHA care plan since 9/8/2021. During an interview on 1/27/2022, at 12:38 PM, the clinical manager indicated the RN should review the HHA care plan at least once a certification period. At 12:40 PM, the clinical manager indicated she was unsure why the RN changed the diastolic blood pressure parameter on the HHA care plan and indicated it should follow the plan of care. 410 IAC 17-13-2(a)

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health aide (HHA) failed to provide services as included in the plan of care in 1 of 1 clinical record review with home health aide services. (#1) The findings include: A review of an agency policy on 1/31/2022, titled “Orientation of Assigned Home Health Aide” revised April 2021, stated, “… Home health aides will receive patient information in the form of an aide assignment prior to caring for the patient. … Each patient receives care in accordance with the plan of care and related instructions….” Clinical record review on for Patient #1 on 1/25/2022, start of care 5/10/2021, evidenced an agency document titled “Aide Care Plan” signed by Employee C, RN and dated 9/8/2021. This document indicated the RN assigned the HHA to obtain vital signs to include blood pressure, pulse, respiration, and temperature at every visit. This document indicated the HHA was to notify the RN if the diastolic (the pressure against the arteries when the heart is at rest and indicated by the bottom number) blood pressure was less than 58. During an observation of care at the patient’s home on 1/25/2022, at 12:35 PM, Employee D, home health aide (HHA) was observed applying a blood pressure cuff to the patient’s left wrist. Employee D indicated the patient’s blood pressure was 118/55. Employee D was not observed notifying the nurse of the patient’s diastolic blood pressure per the HHA care plan. A review of an agency document on 1/28/2022, titled “HHA Visit”, signed by Employee D and dated 1/25/2022, indicated the patient’s blood pressure was 118/55. Record review failed to evidence the HHA communicated to the nurse the patient’s diastolic blood pressure per the HHA care plan. During an interview on 1/31/2022, at 9:56 AM, the clinical manager indicated the HHA should have notified the nurse or the office and indicated the HHA did not notify the nurse or the office of the patient’s diastolic blood pressure.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the home health aide (HHA) failed to report changes in the patient’s condition to the registered nurse in 1 of 1 clinical record review with home health aide services. (#1) The findings include: A review of an agency policy on 1/31/2022, titled “Orientation of Assigned Home Health Aide” revised April 2021, stated, “… When a health problem is identified or a significant change in a patient’s physical condition is noted, the aide will report this information to the coordinator and/or a Clinical Supervisor in the office….” During an observation of care at the home of Patient #1, start of care 5/10/2021, on 1/25/2022, at 1:01 PM, Employee D, home health aide (HHA) was observed assisting the patient with a sink bath in the bathroom. The patient indicated to Employee D he fell out of his wheelchair. Employee D stated, “You fell?” Employee D indicated he fell asleep in his wheelchair and fell out. Employee D was not observed notifying the nurse or the office of the patient’s fall. During an interview on 1/25/2022, at 1:01 PM, the patient’s spouse indicated he had a fall last Thursday. Clinical record review of an agency document on 1/28/2022, titled “HHA Visit”, signed by Employee D and dated 1/25/2022, failed to evidence the HHA reported to the nurse the patient had a fall. During an interview on 1/31/2022, at 9:58 AM, the administrator indicated the patient had not had any falls that had been reported. During an interview on 1/31/2022, at 9:58 AM, the clinical manager indicated if a fall is reported or observed, the staff who was first informed should complete an incident report and indicated the HHA should report the fall to the nurse.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of the patient and personnel assignments. The findings include: A review of an agency document on 1/31/2022, titled “Employee Handbook” dated 1/23/2013, stated, “… Your manager will advise you regarding work schedules and starting times established for your department….” During an interview on 1/25/2022, at 10:23 AM, when the patients’ visit schedules were requested from the administrator, the administrator indicated if she could have the disciplines needed to observe on a home visit and the number of home visits to be conducted. The administrator indicated she did not have a list of which patients were being seen by which staff members and on what day and time. The administrator stated, “I don’t manage that way. I tell staff so-and-so needs to be seen 1 time a week, and they determine the day and time. I’ve always let them determine where they’re going and when, and I won’t be cited.” When queried how staff determines the patient’s visit schedule, the administrator indicated the schedule should be for the benefit of the patient. At 11:04 AM, the administrator provided a handwritten document and indicated there were only 2 visits for the remainder of the week. At 11:20 AM, when queried of the clinical manager’s knowledge of the patients’ visit schedule, the administrator indicated the clinical manager did not know the staff’s schedules. The administrator indicated she did not have the visit schedules for any of the staff members and indicated the staff does not complete and provide to the office their visit schedule for the patient visits to be conducted. Review of an untitled document on 1/25/2022, identified by the administrator as the visit schedule from 1/25/2022 – 1/28/2022, indicated a visit was scheduled during this time with Employee F, RN, and Employee G, Physical Therapist (PT). Review of an agency document on 1/25/2022, titled “Current Employees” evidenced the name of current staff employed by the agency. During an interview on 1/25/2022, at 11:22 AM, the administrator was queried about each name on the current employee list and which patients they provided care for. When queried about Employee H, Licensed Practical Nurse (LPN), the administrator stated, “Oh, I always forget about her. I don’t know. I’ll have to call her and find out.” The administrator indicated there were no home health aide (HHA) visits for the week and indicated the one home health aide visit was already completed for the day. During an interview on 1/25/2022, at 11:29 AM, the administrator indicated Employee D, home health aide (HHA) would be going to see patient #1 in 1 hour and offered the visit as a home visit option. When queried why the administrator indicated there was no home health aide visit for the remainder of the week and the home health aide visit had already been completed, the administrator stated, “Ya, so did I, but she’ll be there in 1 hour, so if you don’t go today, [patient] won’t be seen until next week.” During an interview on 1/26/2022, at 10:35 AM, the clinical manager indicated she was not familiar with each staff member’s visit schedule and stated, “[The administrator] knows more on that than I do.” The clinical manager indicated the administrator was at the agency every day and indicated the clinical manager worked at another agency a few days during the week. 410 IAC 17-14-1(a)(1)(K)

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the administration failed to ensure services provided under arrangement had a written agreement. The findings include: Review of an agency policy on 1/31/2022, titled “Written Agreements for Contracted Services” revised April 2021, stated, “… When the organization provides care and services through another source, the patients are entitled to the same level of performance from that source as from the organization itself. These contracted services will be defined by a written agreement before individuals from that source will be permitted to provide services on behalf of the organization….” During an interview at the entrance conference on 1/25/2022, at 9:42 AM, the administrator indicated Employee I, RN was a nurse consultant and provided the home health aide supervision and conducted the supervisory visits in the patients’ homes. The administrator indicated she did not draw up a contract with the consultant and indicated she went over home health aide competencies and in-services with her verbally. During an interview on 1/26/2022, at 5:07 PM, the administrator indicated there was not a written contract for the nurse consultant. 410 IAC 17-12-2(d)

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a completed discharge summary was sent to the primary care physician within 5 days of discharge from the agency in 2 of 2 closed records reviewed. (#2, #3) The findings include: 1. Review of an agency policy on 1/31/2022, titled “Discharge Summary” revised April 2021, stated, “… Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include as appropriate: … The progress towards goals/desired outcomes … Instructions given to patient or responsible party … A copy of the discharge summary and any necessary medical information will be provided to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient’s discharge….” 2. Clinical record review on 1/26/2022, for Patient #2, start of care 6/25/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] – Discharge” which was digitally signed and dated by Employee C, RN on 1/24/2022. This document indicated the patient was discharged from the agency on 1/24/2022. Review failed to evidence a discharge summary for the patient. Review on 1/27/2022, evidenced an agency document titled “Discharge Summary”, digitally signed and by Employee C and dated 1/24/2022. A request was made to the administrator for a copy of the discharge summary. Review of the printed discharge summary evidenced in writing at the bottom of the page “… Copy sent to [physician] 1/24/22 ….” and evidenced the administrator’s initials. During an interview on 1/27/2022, at 1:45 PM, the administrator indicated the discharge summary was faxed to the physician but there was no fax confirmation document. The administrator indicated the discharge summary was dated by her on the date it was sent to the physician. Review on 1/31/2022, of an agency document titled “Task Details” evidenced the discharge summary was created in the electronic health record on 1/27/2022 by the administrator and was completed in the electronic health record on 1/31/2022 by the administrator. During an interview on 1/31/2022, at 10:07 AM, when the administrator was queried how the discharge summary was sent to the physician prior to the date the task was created and completed in the electronic health record, the administrator said, “No comment.” 3. Clinical record review on 1/26/2022, for Patient #3, start of care 10/10/2020, evidenced an agency document titled “Discharge Summary”, digitally signed by Employee F, RN and dated 1/21/2022. This document evidenced the patient was discharged from the agency on 1/21/2022. This document evidenced a subsection titled “Goals Summary/Outcomes” which failed to be completed. This document evidenced a subsection titled “Discharge Information” which failed to be completed. During an interview on 1/27/2022 at 2:08 PM, the clinical manager indicated the discharge summary should be complete. 410 IAC 17-15-1(a)(6)

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the entries into the clinical record included a signature and date in 1 of 3 active clinical records reviewed. (#5) The findings include: A review of an agency document on 1/31/2022, titled “Clinical/Service Data Collection” revised April 2021, stated, “… The clinical/service note will include: … The date the service was provided … Signature of clinician and his/her credentials ….” Clinical record review on 1/28/2022, for Patient #5, start of care 1/6/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/6/2022 – 3/6/2022, which was signed and dated by the physician on 1/24/2022. This document failed to evidence the signature of the registered nurse and the date the plan of care was completed. During an interview on 1/31/2022 at 11:17 AM, the administrator indicated the signature of the nurse and the date should be included on the plan of care. 410 IAC 17-15-1(a)(7)

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to protect the clinical record and safeguard against loss or unauthorized use. The findings include: A review of an agency policy on 1/31/2022, titled “Patient Privacy Rights” revised April 2021, stated, “… Advanced Home [and] Healthcare will respect and safeguard all protected health information of the patients it serves….” During an observation of care on 1/28/2022, at 11:12 AM, at the home of Patient #5, start of care 1/6/2022, the agency home folder was observed on the patient’s kitchen table. Inside of the agency's home folder was an agency document titled “Home Health Certification and Plan of Care” for Patient #6 for the certification period 12/20/2021 – 2/17/2022. This document included the patient’s name, address, date of birth, diagnoses, medication, and health care information. During an interview on 1/28/2022, at 11:12 AM, when handed the agency document for patient #6 and asked what the document was Employee C, RN indicated it belonged to Patient #5 and handed it back. When directed to look at the patient’s name on the document, Employee C stated, “Oh, you’re right. That’s my fault.” During an interview on 1/31/2022, at 10:26 AM, the clinical manager indicated staff should not take the clinical record of patients into other patients’ homes. During an interview on 1/31/2022, at 10:26 AM, the administrator indicated she gave Employee C the folder for Patient #6 and stated, “I totally take the responsibility for that.” 410 IAC 17-15-1(c)

An Emergency Preparedness post condition survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Facility ID: 011167 Survey dates: 8/12/2021 - 8/18/2021 At this Emergency Preparedness survey, Advanced Home Health Care, Inc., was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement individualized emergency preparedness plans for agency patients which provided appropriate instructions in the event of an emergency in 5 of 7 clinical records reviewed. (#1, #2, #4, #5, #6) 6. Clinical record review on 10/14/2021 for patient #2, start of care 8/28/2021, evidenced an agency document titled "Individualized Emergency Plan" signed by RN F and by patient #2. Review failed to evidence the phone numbers for patient #2's hospital and pharmacy were filled out on the individualized emergency preparedness plan. 7. Clinical record review on 10/14/2021 for patient #5, start of care 9/14/2021, evidenced an agency document titled "Individualized Emergency Plan" signed by RN F and by patient #5. Review failed to evidence the phone numbers for patient #5's hospital, physician, and name and phone number of pharmacy were not filled out on the individualized emergency preparedness plan. During an interview on 10/18/2021 at 10:23 AM when queried as to why the nurse did not completely fill out the individualized emergency preparedness plans for each patient, the clinical manager indicated it was due to the nurse being lazy. 1. Review of an agency policy on 10/14/2021, titled "Emergency Management Plan" revised April 2021, stated, "... Individualized plans for patients during a natural or man-made disaster will be included as part of the comprehensive patient assessment..." 2. Review of an agency policy on 10/14/2021 titled “Admission Criteria and Process” revised April 2021 stated, “ … Upon acceptance into service, the patient will be provided with an organization brochure and various educational materials providing the patient and family/caregiver with sufficient information on: Emergency preparedness plans….” 3. Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled "Individualized Emergency Plan" signed by RN [registered nurse] I. This document failed to evidence the phone numbers for patient #2's physician and durable medical equipment company. This document also failed to evidence patient #1’s transportation needs. During an interview on 10/18/2021 at 12:02 PM the clinical manager indicated the information for the durable medical equipment company, physician and the patients transportation needs should be listed on the emergency plan of care 4. Clinical record review on 10/14/2021 for patient #6, start of care 7/29/2021, failed to evidence an individualized emergency preparedness plan. During an interview on 10/18/2021 at 10:19 AM the clinical manager indicated the emergency preparedness plan may be in the binder and it may not have been uploaded to the computer. The clinical manager left to look in the binder, when she came back to the conference room she indicated there was not an emergency preparedness plan created for patient #6. 5. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled "Individualized Emergency Plan" signed by RN F. This document failed to evidence the phone numbers for patient #4’s durable medical equipment company, hospital and failed to evidence the name and phone number for the patient’s pharmacy. This document also failed to evidence patient #1’s transportation needs. During an interview on 10/15/2021 at 3:44 PM the clinical manager indicated the forms were new and the nurse probably just forgot to go over it.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included a method for sharing information and medical documentation for patients under the agency's care. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... The plan includes the following: ... A method for sharing information and medical documentation for patients under the organization's care as permitted ...." Review on 10/12/2021 of the agency's emergency preparedness binder evidenced an undated agency document titled “Policy on Methods for Sharing Information,” which stated “Advanced Home Healthcare will maintain an updated patient roster that includes all patients receiving services. An individualized emergency plan is maintained in the office for each active patient and can be accessed in case of an emergency. A copy of this plan is also kept in the patient’s home so that the patient can access and bring with him/her in the event of an evacuation. In the event of an actual emergency the emergency plan will be activated, and the incident commander will take control. Our policy is to activate the phone tree to touch base with every employee and every active patient. In the event that we are unable to contact a staff member or a patient, the agency will contact local officials and notify/request a wellness check if possible. Our emergency preparedness plan contains local, state, tribal, national contact information for the use in the event of an emergency.” This plan failed to evidence how medical documentation would be shared in the event of an emergency During an interview on 10/14/2021 at 4:06 PM, the alternate administrator indicated the agency would look up and print out any needed plan of care and give to staff or other health care providers if needed. She indicated the roster just had basic information on it, so they would have to look up more specific patient information

This survey was a Post-Condition Revisit. Dates: 10/12/2021 - 10/18/2021. Facility ID: 011167 Provider ID: 157580 A recertification survey was conducted on 7/12/2021 -7/15/2021 and found Advanced Home Health Care to be out of compliance with Conditions of Participation 484.60 Care Planning, Coordination of Care and Quality of Care, 484.65 Quality Assessment and Performance Improvement, 484.102 Emergency Preparedness and 484.105 Organization and Administration of Services. During this survey, 3 conditions were removed and 1 condition was recited. 33 standards were recited. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this survey Advanced Home Health Care, Inc was found to not meet 1 Conditions of Participation 484.60 Care Planning, Coordination of Care and Quality of Care. Advanced Home Health Care, Inc. is precluded from providing its own home health aide training and competency evaluation for a period of two years from 10/18/2021 - 10/18/2023, due to being found out of compliance with Conditions of Participation 484.60 Care Planning, Coordination of Care and Quality of Care.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure patients received all services ordered in the plan of care in 1 of 5 active clinical records reviewed. (#3) The findings include: An agency policy titled "Scope of Services," with a revision date of November 2017, stated " ... 1. Professional nursing services are provided in accordance with the patient's plan of care, under the supervision of a registered nurse and include: ... B. Initiating the plan of care and revising when necessary C. Providing those services and/or treatments requiring substantial and specialized nursing skill D. Counseling and educating the patient and family/caregiver regarding the disease process, self-care techniques, and prevention strategies ... H. Referral to other services as needed I. Informing the physician and other staff of changes in the patient's needs...." Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 8/28/2021 - 10/26/2021, the diagnoses included, but were not limited to; basal cell carcinoma (cancer) skin/upper eye lid, urinary tract infection, Type 2 diabetes mellitus (insulin resistant disease), heart disease, hypertension (high blood pressure). This document had an area subtitled "Orders and Treatments" which stated " ... SN [Skilled Nursing] 1xwk/1wk [one time a week for 1 week] 2xwk/8wks [2 times a week for 8 week]...." Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, for certification period 10/28/2021 - 10/26/2021, failed to evidence patient #3 was seen by the skilled nurse 2 times per week for the weeks 8/29/2021- 9/4/2021, 9/5/2021 - 9/11/2021, 9/12/2021 - 9/18/2021 and 9/19/2021 - 9/25/2021. During an interview on 10/15/2021 at 11:05 AM, the clinical manager indicated the patient has multiple physician visits and it was hard to get visits in.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to review all medications the patient was currently taking in order to identify any potential adverse effects and drug reactions in 5 of 7 clinical records reviewed. (#1, #2, #3, #4, #6) The findings include: 6. Clinical record review on 10/14/2021, for patient #2, start of care 8/28/2021, evidenced a referral from Physician M dated 8/26/2021, which indicated the patient medications were: "hydralazine [to treat high blood pressure] 25 mg [milligrams] oral tablet, 25 mg = 1 tab(s), By mouth, 3 times a day." Clinical record review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/28/2021 to 10/26/2021. This document had a subsection titled "Medications” which included "... hydralazine HCl Oral 25 MG 1 Tab(s) Twice daily (N).... ” This document failed to evidence the patient’s ordered dosage for Hydralazine. 17-14-1(a)(1)(B) 1. Review of an agency policy on 10/14/2021 titled "Medication Profile," revised April 2021, stated “ ... Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications. ... Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen … 2. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed ... and with the addition of a new medication. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy and noncompliance with drug therapy...." 2. Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/22/2021 to 10/20/2021. This document had a subsection titled "Medications” which stated “Lisinopril (for high blood pressure) 10 MG [Milligrams] 1 tab daily [tablet]via Gtube (gastrostomy tube which is placed in the stomach for receiving nutritional supplements) TYLENOL Extra Strength (for pain) 500 MG every 6 hours PRN [as needed] pain via Gtube Pantoprazole Sodium (for gastroesophageal reflux disease) 40 MG 1 Tab daily via Gtube Atorvastatin Calcium (for high cholesterol) 40 MG 1 tab daily via GTube….” This document failed to include all the patient’s current medications in accordance with their primary physician Clinical record review on 10/14/2021 evidenced a referral from Physician E dated 8/19/2021 which indicated the patient medications were: Atorvastatin, Lisinopril, Potassium Chloride (treats low potassium), Pantoprazole, Ipratropium Bromide (opens airways in the lungs), Albuterol Sulfate (used to treat wheezing and shortness of breath), Aspirin (reduces risk of heart attacks, treats pain and inflammation) and Ferrex (iron supplement). Clinical record review on 10/14/2021 evidenced an agency document titled “Patient Medication Record" which indicated patient #1’s medications were “Lisinopril Tylenol Extra Strength Pantoprazole Sodium, and Atorvastatin Calcium. This document failed to include all the patient’s current medications. 3. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/28/2021 to 10/26/2021. This document had a subsection titled "Medications” which indicated patient #3’s medications were: Temazepam (for sleep), Effexor (for depression), Norco (for pain), Bactrim DS (for infection), Mupirocin (treats skin infections), Keppra (for seizures), glipizide (for high blood sugar), Eliquis (for blood clots), Gabapentin (for nerve pain), Potassium (Supplement), Pravastatin (for high cholesterol), Singulair (wheezing and shortness of breath), Mirapex (for restless leg syndrome) , metformin (for high blood sugar), Lasix (for fluid retention), spironolactone (for high blood pressure), and Prilosec (for heart burn). Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled “Patient Medication Record.” This document indicated patient #3’s medications were: Temazepam, Effexor, Norco, Bactrim DS, Mupirocin, Keppra, glipizide, Eliquis, Gabapentin, Potassium, Pravastatin, Singulair, Mirapex, metformin, Lasix, spironolactone, and Prilosec. During a home visit on 8/15/2021 at 12:06 PM patient #3 indicated she had been on Bactrim and doxycycline previously, but it was not working so the physician changed the medication to Cipro. She indicated she had just picked up the second supply of Cipro from the pharmacy. Patient #3 said she was on Cipro for the last 10 days and her physician decided she needed an additional 14-day supply. Review of the plan of care and the Medication profile failed to evidence the Bactrim had been discontinued and patient #3 was started on Cipro. During an interview on 10/18/2021 at 12:05 PM the clinical manager stated the medication profile and plan of care should have been updated to include the Cipro. 4. Clinical record review on 10/14/2021 for patient #6 evidenced a referral from physician I indicated the patient’s medications were: Norco 7.5/325 mg, cholecalciferol (vitamin D)25 mcg (micrograms), triamterene—hydrochlorothiazide (fluid retention) 37.5-25 mg, Celebrex 200 mg, Adderall 20 mg, Duloxetine 60 mg, guaifenesin 600 mg, Lisinopril 40 mg, Metoprolol 50 mg, trazadone (for sleep and depression) 100 mg, Verapamil 240 mg, Wellbutrin 300 mg and Xanax 0.5 mg. Clinical record review on 10/14/2021 for patient #6, start of care 7/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/29/2021 to 9/26/2021. This document had a subsection titled "Medications” which indicated patient #6’s medications were: Norco (for pain) 5/325 mg (milligrams) Celebrex (for nerve pain) 200 mg, Adderall (for attention deficit disorder) 20 mg, Duloxetine (for depression and nerve pain) 60 mg, guaifenesin (for cough) 600 mg, Lisinopril (for high blood pressure) 40 mg, Metoprolol (for high blood pressure) 50 mg, trazodone (for sleep and depression) 100 mg, Verapamil (for high blood pressure) 240 mg, Wellbutrin (for depression) 300 mg and Xanax (for anxiety) 0.5 mg. Clinical record review on 10/14/2021 for patient #6, start of care 7/29/2021, evidenced an agency document titled “Patient Medication Record.” This document indicated patient 6’s medications were but not limited to: Norco 5/325 mg, Celebrex 200 mg, Adderall 20 mg, Duloxetine 60 mg, guaifenesin 600 mg, Lisinopril 40 mg, Metoprolol 50 mg, trazadone (for sleep and depression) 100 mg, Verapamil 240 mg, Wellbutrin 300 mg and Xanax 0.5 mg. Review on 10/14/2021 of the website https://reference.medscape.com/drug-interactionchecker found 44 interactions between the medications (6 of which were serious interactions and should be avoided together, and 4 would need close monitoring) patient #6 was taking. Review on 10/14/2021 of the website https://www.drugs.com/drug_interactions.html found 28 interactions between medications patient #6 was taking. Record review on 10/14/2021 failed to evidence any documentation the agency discussed any drug interactions with the physician. During an interview on 10/18/2021 at 10:13 AM, the clinical manager indicated the electronic system they use for patient information alerts them to drug interactions. When an interaction was found it would be discussed with the physician. She indicated for patient #6 their system only found food-drug interactions. The clinical manager indicated all medications the patient was currently taking should be listed in the plan of care and the medication record. 5. Clinical record review on 10/14/2021 for patient #4, evidenced a referral from hospital J which indicated the patient’s medications were: Levothyroxine(for thyroid) 50 mcg, Montelukast (for asthma) 10 mg, Carvedilol (for high blood pressure) 12.5 mg, Insulin Gulisine (for high blood sugar) 100 units, Aspirin 81 mg (blood thinner and reduces heart attack risk), Atorvastatin 40 mg (for high cholesterol), Lisinopril 10 mg (for high blood pressure), Insulin Lispro (for high blood sugar) 100 units. Enoxaparin (blood thinner) 30 mg, Ergocalciferol (Vitamin D) 5000 units, ferrous Sulfate (iron supplement) 324 mg, hydrocodone/APAP 5 mg-325mg. This document also indicated patient #4 had sleep apnea and was on a CPAP (continuous positive airway pressure) at night Clinical record review on 10/14/2021 for patient #4, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/28/2021 to 10/26/2021. This document had a subsection titled "Medications” which indicated patient #4’s medications were: Tylenol Extra Strength (for pain) 500 mg, Levothyroxine (for thyroid) 50 mcg, Montelukast 10 mg, Carvedilol, Insulin Gulisine 100 units, Aspirin 81 mg, Atorvastatin, Lisinopril, Insulin Lispro 100 units. This document failed to evidence all of the patient’s current medications, and failed to evidence the patient was on CPAP at night. During an interview on 10/15/21 at 3:32 PM the clinical manager indicated she was unsure why the medications were not on the plan of care, but she was unsure if the patient had these medications at home. She indicated if there was a question about the medications the nurse would talk to the physician when they reconciled them. The clinical manager indicated the CPAP should have been included on the patient's plan of care.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: the plan of care was reviewed by the physician, individualized and followed by all agency staff (See tag G0572); the plan of care included all required information / elements for the treatment of the patient (See tag G0574); all patient care orders, including verbal orders, were recorded in the plan of care (See tag G0576); services and treatment were provided as ordered by a physician (See tag G0578); all treatments provided by agency staff were ordered by a physician (See tag G0580); physicians were promptly notified of a change in the patient's condition (See tag G0590); the plan of care was revised to reflect current health status and nursing needs (See tag G0592); coordination of care for all services provided to the patient (See tag G0606); the written visit schedule was provided to patients (See tag G0614); and written instructions were provided to the patient for the patient's medication schedule and instructions (See tag G0616). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the agency failed to ensure the patients received the services as directed in the plan of care and the plan of care was individualized in 3 of 5 active clinical records reviewed (#3, #4, #7) The findings include: 5. Clinical record review on 10/14/2021 for patient #7, start of care 5/7/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 7/6/2021 - 9/3/2021. This document indicated the patient's diagnoses included, but were not limited to, Type 2 Diabetes Mellitus [insulin resistant disease] with foot ulcer, Heart failure, Bipolar disorder, Dependence on renal dialysis [process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally], and Long term (current) use of insulin [allows the body to use sugar from carbohydrates in food]. This document had an area subtitled "Orders and Treatments" which stated "Notify physician of Temperature greater than (>) 100.5 or less than () 120 or less than () 30 or less than ()160 or less than () 90 or less than (] Sat [saturation] less than ( During an interview on 10/18/2021 at 12:21 PM, the clinical manager confirmed the blood sugar parameters were missing from patient #7's plan of care. 17-13-1(a) Based on observation, record review and interview, the agency failed to ensure the patients received the services as directed in the plan of care and the plan of care was individualized in 3 of 5 active clinical records reviewed (#3, #4, #7) 1. An agency policy reviewed on 10/14/2021, titled “Care Planning Process" revised April 2021, stated “ … and the responsible discipline(s), treatments and procedures … the patient specific clinical plan of care includes .. Orders for patient specific home health services identified in the comprehensive assessment Based on assessment and conclusions the plan of care will include, but not be limited to: … Specific services and treatments to be provided including services furnished via telecommunication systems (if appropriate)….” 2. An agency policy reviewed on 10/14/2021, titled “Scope of Services" revised April 2021, stated “Professional nursing services are provided in accordance with the patient's plan of care ... Rehabilitative therapies are provided according to the patient's plan of care ... Home Health aide duties … Social work services are provided according to the patient's plan of care ...." 3. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 8/28/2021 - 10/26/2021. This document indicated the patient's diagnoses included, but were not limited to; Basal cell carcinoma skin left upper eye lid (skin cancer), urinary tract infection, heart failure and chronic obstructive pulmonary disease (disease that blocks the airflow in the lungs), and Diabetes Mellitus type 2 (an insulin resistant disease). This document indicated the patient was to be seen for wound care twice per week for eight weeks. This document had an area subtitled "Orders and Treatments" which stated "Notify physician of Temperature greater than (>) 101.5 or less than () 120 or less than () 30 or less than ()160 or less than) 90 or less than () 101.5 or less than () 120 or less than () 30 or less than ()160 or less than) 90 or less than (<) 58 O2 Sat [saturation] less than (<) 90...." This document failed to evidence the parameters were specific to the patients diagnoses and included blood sugar parameters. During an interview on 10/15/2021 at 3:02 PM the clinical manager indicated patient #4 should have blood sugar parameters listed on the plan of care but they are not on there.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the individualized plan of care included all medications and treatments in 3 of 5 active clinical records reviewed (#1, #3, #7) The findings include: 4. Clinical record review on 10/14/2021 for patient #7, start of care 5/7/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/6/2021 to 9/3/2021. This document had a subsection titled "Allergies” which stated “Depakote [a drug used to treat seizures and bipolar disorder], and Morphine and Related [sic] [a drug used to treat moderate to severe pain].” This document failed to include all of patient #7's allergies. Clinical record review on 10/14/2021 evidenced a referral from physician G dated 6/18/21 which stated patient #7's allergies were "Valproic Acid [a medication used to treat seizures and bipolar disorder], Strawberry, Depakote (Divalproex), Lamictal (Lamotrigine) [a medication used to treat seizures and bipolar disorder], and Morphine. Clinical record review on 10/14/2021 evidenced an agency document titled “Physician Order" dated 8/31/2021 and digitally signed by RN I which indicated patient #7’s allergies were "Depakote - swelling Morphine and Related - Hallucinations." This document failed to include all the patient’s allergies. During an interview on 10/18/2021 at 12:29 PM, the clinical manager indicated the RN transfers the patient's allergies from the physician's referral order. 17-13-1(a)(1)(C ) 17-13-1(a)(1)(D)(ix, xiii) 1. Review of an agency policy on 10/15/2021 titled "Care Planning Process" revised April 2021, stated, "... Individualized Plan of Care: The patient-specific clinical plan of care includes: All pertinent primary and secondary diagnoses All patient care orders including verbal orders Food or drug allergies … Medication including dose/frequency/route … Patient and caregiver education and training….” 2. Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/22/2021 to 10/20/2021. This document had a subsection titled ‘Medications” which stated “Lisinopril (for high blood pressure) 10 MG [Milligrams] 1 tab daily [tablet]via Gtube TYLENOL Extra Strength (for pain) 500 MG every 6 hours PRN [as needed] pain via Gtube Pantoprazole Sodium (for gastroesophageal reflux disease) 40 MG 1 Tab daily via Gtube Atorvastatin Calcium (for high cholesterol) 40 MG 1 tab daily via GTube….” This document failed to include all the patient’s current medications. Clinical record review on 10/14/2021 evidenced a referral from Physician E dated 8/19/2021 which indicated the patient medications were: Atorvastatin, Lisinopril, Potassium Chloride (treats low potassium), Pantoprazole, Ipratropium Bromide (opens airways in the lungs), Albuterol Sulfate (used to treat wheezing and shortness of breath), Aspirin (reduces risk of heart attacks, treats pain and inflammation) and Ferrex (iron supplement). Clinical record review on 10/14/2021, evidenced an agency document titled “Patient Medication List" which indicated patient #1’s medications were: Lisinopril Tylenol Extra Strength Pantoprazole Sodium, and Atorvastatin Calcium. This document failed to include all the patient’s current physician ordered medications. During an interview on 10/18/2021 at 12:05 PM the clinical manager indicated she did not see all of the patient’s medications listed on the plan of care and the medication profile. She indicated they should be listed if the patient still takes them. 3. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/28/2021 to 10/26/2021. This document had a subsection titled "Medications” which indicated patient #3’s medications were: Temazepam (for sleep), Effexor (for depression), Norco (for pain), Bactrim DS (for infection), Mupirocin (treats skin infections), Keppra (for seizures), glipizide (for high blood sugar), Eliquis (for blood clots), Gabapentin (for nerve pain), Potassium (Supplement), Pravastatin (for high cholesterol), Singulair (wheezing and shortness of breath), Mirapex (for restless leg syndrome) , metformin (for high blood sugar), Lasix (for fluid retention), spironolactone (for high blood pressure), and Prilosec ( for heart burn). This document failed to include all of patient #3’s current medications. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled “Medication Profile.” This document indicated patient #3’s medications: Temazepam, Effexor, Norco, Bactrim DS, Mupirocin, Keppra, glipizide, Eliquis, Gabapentin, Potassium, Pravastatin, Singulair, Mirapex, metformin, Lasix, spironolactone, and Prilosec. This document failed to include all of the patient’s current medications During a home visit on 10/15/2021 at 12:06 PM, patient #3 indicated she had been on Bactrim and doxycycline previously, but it was not working so the physician changed the medication to Cipro. She indicated she had just picked up the second supply of Cipro from the pharmacy. Patient #3 said she was on Cipro for the last 10 days and her physician decided she needed an additional 14-day supply. Review of the plan of care and the Medication profile failed to evidence the Bactrim had been discontinued and patient #3 was started on Cipro. During an interview on 10/18/2021 at 12:05 PM the clinical manager stated the medication profile and plan of care should have been updated to include the cipro.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to provide services and treatment as ordered by a physician in 2 of 5 active clinical records reviewed. (#4, #6) The findings include: 1. Review of an agency policy on 10/14/2021 titled "Physician Participation in Plan of Care” revised April 2021 stated, "... The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice...." 2. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an untitled prescription signed by physician K and dated 9/9/2021. This document indicated the patient was to have the following tests CBC (complete blood count; a group of tests run from a blood sample that evaluate the cells that circulate in the blood), and Chem 12 (blood test that test 12 different blood counts in the body). Review failed to evidence the agency conformed with the physician's order and obtained the blood test. During an interview on 10/17/2021 at 3:36 PM, the clinical manager indicated the nurse went to do the blood test on 9/10/2021 and was unable to obtain the blood. Clinical record review failed to evidence documentation on the nurse attempting the blood draw. She then indicated the blood was drawn by agency L on 10/16/2021. No further documentation was provided to the surveyors. 3. Clinical record review on 10/14/2021 for patient #6, start of care 7/29/2021, evidenced a referral from physician N. This document evidenced an order for physical therapy services to evaluate and treat. Clinical record review on 10/14/2021 for patient #6, start of care 7/29/2021, failed to evidence the patient received any physical therapy. During an interview on 10/18/2021 at 10:07 AM, the clinical manager indicated the patient was not sure if she wanted therapy so they were waiting for her to decide.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide treatments only as ordered by a physician in 2 of 7 clinical records reviewed. (#4, #7) The findings include: 4. Clinical record review for patient #4, start of care 8/28/2021, evidenced an agency document titled “Skilled Nursing Visit” dated 9/6/2021, and digitally signed by RN F. This document indicated RN F provided wound care to patient #4. This document indicated RN F applied Duoderm (dressing used to prevent further skin break down) to sore and bottom of the wound on the patient’s left groin to thigh. Clinical record review for patient #4 evidenced an agency document titled “Home Health Certification and Plan of Care,” for certification period 8/28/2021 to 10/26/2021. This document indicated the wound care orders were to change wound vac three times per week and as needed. Use a wet to dry dressing when wound vac was not functioning. This document failed to evidence an order for a duoderm dressing. During an interview on 10/15/2021 at 2:57 PM, the clinical manager indicated she did not see an order for a duoderm dressing and was not sure why the nurse used it. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/28/2021 to 10/26/2021, digitally signed by RN F. This document indicated for the patient’s wound vac to be changed three times a week and as needed. This document failed to evidence the wound vac settings. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced agency documents titled “RN-Skilled Nursing Visit” digitally signed by RN F and dated 9/1/2021, 9/6/2021, 9/8/2021, 9/10/2021, 9/15/2021, 9/13/2021, 9/17/2021, 9/20/2021, 9/22/2021, 9/27/2021, 9/29/2021, 10/1/2021, 10/4/2021, 10/6/2021, 10/11/2021, and 10/13/2021. These documents indicated the patient's wound vac was set at 125 mmHg [millimeter Mercury]. During an interview on 10/15/2021 at 3:02 PM, the clinical manager indicated she could not find specific settings for the wound vac. 17-13-1(a) 1. Review of an agency policy, revised April 2021 and obtained 10/14/2021, titled "Physician Participation in Plan of Care," stated, "...Orders will be reviewed and revised by the patient's physician (or other authorized licensed independent practitioner) based on: A. Changes in the care or service being provided, ... E. Changes in diagnosis or treatment, including procedures, medications and equipment...." 2. Review of an agency policy, revised April 2021, and obtained 10/14/2021, titled "Verification of Physician Orders," stated, "Orders will be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients. ... A qualified individual will review each order or prescription before care is provided...." 3. Clinical record review on 10/14/2021 for patient #7, start of care 5/7/2021, evidenced an agency document titled "RN [registered nurse] Skilled Nursing Visit" dated 8/18/2021, and digitally signed by RN F, which indicated the patient had a wound measuring 1cm [centimeter] long by 1 cm wide by 0.3 cm deep to the top of the left foot. The document indicated RN F treated the wound by leaving it open to air. Clinical record review failed to evidence a physician order to leave the wound open to air. Clinical record review on 10/14/2021 for patient #7, start of care 5/7/2021, evidenced an agency document titled "Physician Order" dated 7/7/2021 digitally signed by RN F and signed by physician D on 7/20/2021. This document was the most recent wound care order in patient #7's chart, which indicated the RN should begin using Hydrofera Blue [a dressing that provides an antibacterial healing environment and protection for the wound] and a dry sterile dressing on the wound. During an interview on 10/18/2021 at 12:44 PM, the alternate clinical manager indicated there was no order for the wound to be left open to air.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to promptly alert the physician to changes in the patient's condition in 4 of 5 active clinical records reviewed. (#2, #3, #4, #5) The findings include: 5. Clinical record review on 10/14/2021 for patient #5, start of care 9/14/2021, evidenced an agency document titled "PT [physical therapy] Visit" dated 10/5/2021, and digitally signed by PT H, which indicated the patient complained of severe dizziness and passed out during the visit. The document indicated PT H then called the agency and spoke with the clinical manager over the phone about the incident. Further clinical record review failed to evidence documentation the physician was notified of this event. During an interview on 10/18/2021 at 10:45 AM, the clinical manager and alternate clinical manager indicated the physician should have been notified. 6. Clinical record review on 10/18/2021 for patient #2, start of care 8/28/2021 evidenced an agency document titled "Patient Notes/Messages" dated 9/26/2021 and digitally signed by RN G and the clinical manager. The patient note from RN G to the clinical manager stated, "Are yoou [sic] aware that the patient cancelled PT visit 9/21 due to bleeding from her leg?" The documented reply from the clinical manager to RN G stated, "NO I AM NOT [sic]." Further clinical record review failed to evidence documentation the physician was notified of this event. During an interview on 10/18/2021 at 11:53 AM the clinical manager indicated PT H did not mention patient #2's leg in the PT visit documentation on 9/21/2021. Clinical record review on 10/14/2021 for patient #2, start of care 8/28/2021, evidenced an agency document titled "RN Visit" digitally signed by RN G. This document had a subsection titled "Cardiovascular" that stated, "Comments: c/o [complains of] chest pressure the day before." Record review failed to evidence documentation the physician was notified the patient had been having chest pressure. During an interview on 10/18/2021 at 11:50 AM, the clinical manager indicated that patient #2 should have called the agency when he/she was having the chest pressure. 17-13-1(a)(2) 1. An agency policy reviewed on 10/15/2021 titled “Care Planning Process,” revised April 2021, stated “ … Clinicians will inform the patient’s physician (or authorized licensed independent practitioner) of any changes that suggest a need to alter the plan of care….” 2. An agency policy reviewed on 10/15/2021 titled “Scope of Services,” revised April 2021, stated “Professional nursing services are to be provided in accordance with the patient’s plan of care, under the supervision of the registered nurse and include: … Informing the physician and other staff of changes in the patient’s needs….” 3. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled "OASIS D1- Start of Care" dated 8/28/2021 and digitally signed by RN [registered nurse] F. This document evidenced a subsection titled ADL/IADLs [Activities of Daily Living/ Independent Activities of Daily] living which stated, “Sleeping in living room recliner as she has a headache when lying flat.” The clinical record failed to evidence documentation the physician was notified of the headaches when lying flat. During an interview on 10/18/2021 at 10:55 AM the clinical manager indicated the nurse always calls the physician at the start of care and gives report. She indicated the nurse most likely told the physician of the headaches when lying flat when she made the call. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021 evidenced an agency document titled "RN Skilled Nursing Visit" dated 9/7/2021 and digitally signed by RN G. This document indicated the patient had pain 3 out of 10 (on a 0-10 pain scale where 0 is no pain 10 is the most severe pain) with quick movements of her head. The clinical record failed to evidence documentation the physician was notified of this pain. During an interview on 10/18/2021 10:55 AM the alternate clinical manager indicated the physician should be notified of pain if the patient was not experiencing pain on prior visits or if there is pain being documented every visit. 4. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced agency documents titled “RN Skilled Nursing Visit” dated 9/22/2021 and 9/27/2021, digitally signed by RN F. These documents indicated the patient was experiencing dizziness if she stands too quickly. Clinical record review failed to evidence documentation the RN notified the physician of the patient's dizziness. During an interview on 10/15/2021 at 3:26 PM the clinical manager when queried as to what the nurse should have done for the patient’s dizziness indicated as long as the vital signs were within parameters, she wouldn't be too worried about calling the physician and then stated “I wonder what she told the patient.”

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to revise the plan of care to reflect current health status and nursing needs in 2 of 5 active clinical records reviewed. (#1, #3) The findings include: 1. Review of an agency policy received 10/14/2021, titled "Care Planning Process" revised April 2021, stated, "... The plan of care will be based upon the physician's (or other authorized licensed independent practitioner's) orders and will encompass the equipment, supplies, and services required to meet the patient's needs. ... The plan of care will be revised as frequently as deemed necessary by the clinicians based on the ongoing assessments of the patient. ... Changes in the plan of care will be noted with the following documentation: ... Assessment ... Verbal orders ... Changes must be written, dated and signed by the professional making the changes...." Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Physician Order” dated 9/2/2021 and digitally signed by RN [registered nurse] I stated “Left buttock: cleanse area with NS [normal saline], pat dry, cover with duoderm (wound dressing) every 3-5 days and PRN (as needed). Apply barrier cream with A &D ointment to peri area/ groin. Caregivers to apply with each diaper change….” Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Physician Order” dated 9/1/2021 and digitally signed by RN I, which stated “Left lower leg cleanse with normal saline, pat dry, cover wounds with adaptic, dry gauze, wrap with kerlix, secure with tape three times/week. Left elbow cleanse with normal saline, pat dry, cover wounds with adaptic, dry gauze, wrap with kerlix, secure with tape three times/week. Left hand wound cleanse with normal saline, pat dry, cover wounds with adaptic, dry gauze secure with tape three times/week.” Clinical record review evidenced an agency document titled “Home Heath Certification and Plan of Care,” for certification period 8/22/2021 to 10/20/2021. This plan of care evidenced patient #1 was to be seen by skilled nursing three times a week for eight weeks. Skilled nursing was to cleanse left lower leg/knee wounds with normal saline, pat dry and apply adaptic, dry gauze, wrap with kerlix and secure with tape three times a week. The plan of care failed to be revised to include the change in nursing visits and the new wound treatments. During an interview on 10/18/2021 at 12:09 PM, the clinical manager indicated the plan of care should be updated to include any new orders for the patient. 3. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled “Physician Order” dated 9/17/2021, and digitally signed by RN G. This document stated “SN [Skilled Nurse] to perform wound care to left orbital socket twice a week. Clean orbital wound with NS, then pack with stripe of vigilon (non-adherent hydrogel dressing) then folded 2x2 dry gauze.” An agency document titled “Physician Order” dated 10/4/2021, and digitally signed by RN G stated, “pack left eye socket with moistened saline gauze twice per day.” An agency document titled “Home Health Certification and Plan of Care,” for certification period 8/28/2021 to 10/26/2021, evidenced a subsection titled “Orders and Treatments” which indicated the skilled nurse would see the patient once a week for one week and twice a week for eight weeks. This document failed to be updated with the wound care orders. During an interview on 10/18/2021 at 11:20 AM, the clinical manager indicated the patient's orders were changed by the physician, but did not get updated on the plan of care.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care of services provided to the patient in 2 of 5 active clinical records reviewed. (#1, #3) The findings include: 1. Review of an agency policy on 10/15/2021, titled "Coordination of Services with Other Providers," revised April 2021, stated " ... A Case Manager will be assigned to be responsible for coordinating services provided to the patient by the organization, including services provided directly and through contract. The Case Manager will act as liaison with other organizations or individuals also providing care to the patient to assure effective coordination of related services….” 2. Clinical record review on 10/14/2021, for patient #3, start of care 8/28/2021, evidenced the patient was seeing Physician C at the wound care clinic. Review failed to evidence documentation of coordination of care with the wound care clinic. During a home visit on 10/15/2021 at 12:05 PM, patient #3 indicated she had been to the wound clinic the prior day, when the nurse inquired when she would be going to the wound clinic she indicated she had an appointment on 10/19/2021. Review of patient #3 clinical record failed to evidence documentation of coordination of care with the wound clinic. During an interview on 10/18/2021 at 11:31 AM, the clinical manager indicated she did not recall any documentation from the wound clinic in the patient’s clinical record. The clinical manager indicated providers are usually told to fax over any documents relating to the patients care and the office coordinator would upload them to the patient’s file. 3. Clinical record review on 10/14/2021, for patient #1, start of care 8/22/2021, evidenced an agency document titled “OASIS-D1 Start of Care.” This document indicated patient #1 was being seen by nursing for tube feeding and home health aides for 24 hour care from agency A. During an interview on 10/14/2021at 10:30 AM, RN [registered nurse] I indicated she was doing the wound care for the patient because agency A does not accept Medicare. She indicated agency A does the tube feedings and provides 24 hour care for patient #1. Clinical record review on 10/14/2021 for patient #1, evidenced agency documents titled "RN Skilled Nursing Visit” dated 8/28/2021, 8/30/2021, 9/1/2021, 9/4/2021, 9/8/2021, 9/11/2021, 9/14/2021, 9/17/2021, 9/20/2021, 9/23/2021, 9/27/2021, 10/1/2021, 10/5/2021, 10/9/2021, and 10/11/2021. These documents failed to evidence documentation of coordination of care with agency A. During an interview on 10/18/2021 at 12:01 PM, the clinical manager indicated Agency A was he primary agency for patient #1. She indicated if coordination of care was needed it would be listed in the note section on nursing visit notes. 17-12-2(h)

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview the home health agency failed to ensure the written visit schedule was provided to patients in 2 of 3 home visit patients observed (#1, #5) The findings include: 1. An agency policy titled "Care Planning Process," revised April 2021, stated " ... 16. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including the frequency of visits by personnel and personnel acting on behalf of the organization...." 2. During an interview on 10/14/2021 at 10:22 AM, patient #5 indicated she did not have a calendar from the agency they just tell her when the next time they would be coming to the house will be. Observation of a home visit for patient #5 on 10/14/2021 at 10:22 AM, failed to evidence a written visit schedule was provided to the patient, from the home health agency. 3. During an interview on 10/13/2021 at 10:13 AM, RN [registered nurse] I, caregiver to patient #1, indicated she did not see a calendar in his folder, but it should be in there. She indicated the family may have taken it out. Observation of a home visit for patient #1 on 10/13/2021 at 10:13 AM, failed to evidence a written visit schedule was provided to the patient, from the home health agency. During an interview on 10/18/2021 at 12:05 PM, the clinical manager indicated all patients should have a visit schedule in their home.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation record review and interview, the agency failed to provide written instructions to the patient regarding, patient's medication schedule and medication instructions in 2 of 3 home visits conducted. (#1, #5) The findings include: 3. Clinical record review on 10/14/2021 for patient #5, start of care 9/14/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 9/14/2021 to 11/12/2021. This document had a subsection titled "Medications” which stated “Tylenol [for pain] Oral 325 MG [milligrams] 2 Tab(s) Every 4 hours as needed for pain (N), Potassium Chloride Crys ER [mineral supplement used to treat or prevent low amounts of potassium in the blood] Oral 20 MEQ [milliequivalents] 1 Tab(s) Twice daily (N), Zyrtec Allergy [to relieve allergy symptoms] Oral 10 MG 1 Tab(s) Daily....” During a home visit on 10/13/21 at 11:02 AM, an agency folder was observed on patient #5's table. The folder did not contain a written medication schedule for patient #5. 1. Review of an agency policy received 10/15/2021, titled "Medication Profile." revised April 2021, stated, "... Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications ... the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver as well as other clinicians understand the medication regimen. ... Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the medication...." 2. Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/22/2021 to 10/20/2021. This document had a subsection titled "Medications,” which stated, “Lisinopril (for high blood pressure) 10 MG [Milligrams] 1 tab daily [tablet] via Gtube [gastrostomy tube for feeding supplemental nutrition directly into the stomach] TYLENOL Extra Strength (for pain) 500 MG every 6 hours PRN [as needed] pain via Gtube Pantoprazole Sodium (for gastroesophageal reflux disease) 40 MG 1 Tab daily via Gtube Atorvastatin Calcium (for high cholesterol) 40 MG 1 tab daily via GTube….” During an observation of care at the home of patient #1, start of care 8/22/2021, on 10/14/2021 at 10:55 AM, an agency folder was reviewed which failed to evidence a medication profile or plan of care with the patient's medication listed with written instructions. During a home visit on 10/14/21 at 10:30 AM, an agency folder was observed on the patient’s counter. The folder did not contain a written medication schedule for patient #1. During an interview on 10/18/2021 at 3:58 PM, the clinical manager indicated there should be a written medication schedule and instructions in the patients' home folders.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the performance improvement activities focused on high risk or problem-prone areas. The findings include: Review of an agency document received 10/13/2021 titled "Improving Organizational Performance," revised April 2021, stated, " ... Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. ... Senior management with Governing Body oversight will: ... Adopt a structured framework for performance improvement. The problem-solving approach will stress the interrelationship of quality services provided ... as applicable to ... Activities related to patient care and patient safety focusing on high risk, high volume and problem prone areas and consider the incidence, prevalence, and severity...." Review of an agency document titled "Home Health Care Insights-Population View", dated 7/14/2021, indicated 14 of 37 patients were assessed to be at a "very high" hospitalization risk. This document indicated 36% of patients had an acute care hospitalization in January 2021; no data for February 2021; 10% of patients had an acute care hospitalization in March 2021; 15% of patients had an acute care hospitalization in April 2021 and 13% had an acute care hospitalization in May 2021. No new information was provided for the months of July, August, September, or October. Review of the hospitalization log on 10/14/2021 evidenced 15 patients were hospitalized since 8/11/2021. During an interview on 10/15/2021 at 3:00 PM, when queried about what actions the agency has put into place regarding the patient hospitalizations, the clinical manager indicated they will be giving out handouts to the patients and caregivers, they will do additional phone calls with the patients and caregivers, and they will have weekly case conferences about high-risk patients.

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to document the quality improvement projects, the reasons for conducting these projects, and the measurable progress achieved. The findings include: Review of an agency policy received 10/14/2021, titled "Improving Organizational Performance," revised April 2021, stated " ... Ensure that the performance improvement projects (PIPs) are conducted that reflect the following: ... The organization must document the quality improvement projects undertaken, the reasons for conducting the projects, and the measurable progress achieved on these projects...." Review of the agency's Quality Assurance and Performance Improvement (QAPI) binder on 10/14/2021 failed to evidence performance improvement projects. During an interview on 10/15/2021 at 3:18 PM, the clinical manager indicated the performance improvement projects they were working on included patient hospitalizations, dyspnea (difficulty breathing) and patients with ambulation issues. When queried where was the documentation related to the performance improvement projects, the clinical manager indicated she would look for the documentation. No additional documentation was provided.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure all employees practiced standard precautions and followed agency infection control policies and procedures at 3 of 3 home health visits with a registered nurse. (#1, #3, #5) The findings include: 5. During a home visit for patient #1, on 10/14/2021 at 9:30 AM RN (registered nurse) I was observed providing wound care to patient #1’s left leg. RN I sanitized her hands and applied two pair of gloves to each hand. RN I removed the bandage from patient #1’s left leg and cleaned the three scabbed areas with normal saline. RN I removed one pair of gloves from both hands and applied a new dressing and taped it in place, failing to wash her hands prior to applying the new bandage to the patient #1’s leg. RN I removed her gloves, sanitized her hands and donned a new pair of gloves. RN I wiped stool from patient #1’s buttock and opened a tube of diaper rash ointment and applied it to the patient’s buttocks, failing to remove her gloves and sanitize her hands prior to applying the ointment. During an interview on 10/15/2021 at 3:47 PM, the clinical manager indicated staff should wash their hands before touching anything, before putting on gloves, and after taking off their gloves. 6. During a home visit on 10/15/2021 at 12:00 PM RN G was observed performing wound care for patient #3. RN G washed her hands in the patient’s bathroom, came to the dining room and gave two treats to the patient’s dog, she then donned a pair of gloves failing to wash her hands after giving treats to the dog. RN G removed her stethoscope, blood pressure cuff, thermometer, and pulse oximeter out of her bag, placed them on a barrier and obtained the patient’s vital signs, removed her gloves, and donned a new pair of gloves, failing to wash her hands prior to donning new gloves. RN G removed the dressing from patient #3’s eye and wrapped it in her glove, removed her gloves and donned a new pair of gloves, failing to sanitize her hands prior to donning new gloves. RN G then dabbed the patient’s wound with a long cotton swab, took off her gloves and donned new gloves, failing to wash her hands after removing prior to donning new gloves. RN G packed the wound with normal saline soaked gauze. She then touched a cotton swab to the wound near patient #3’s left temple some yellow discharge was observed to have come out of the wound. Patient #3 mentioned she could feel that in her eye and asked if they could check the dressing. RN G removed her gloves, donned new gloves, failing to wash her hands prior to donning her new gloves. RN G removed patient #3’s dressing removed her gloves, donned a new pair of gloves failing to wash her hands, and wiped area with a cotton swab. RN G removed her gloves, donned new gloves, failing to wash her hands prior to donning new gloves. RN G packed the wound with new saline-soaked gauze and removed her gloves, failing to sanitize her hands after removing her gloves. RN G wiped her stethoscope with an antibacterial wipe and placed it back on the barrier cleansed the blood pressure cuff and placed it back on the barrier, cleansed the thermometer and placed it back on the barrier, and then cleansed the pulse oximeter and put it back on the barrier. After all items were cleansed she put them in her bag, failing to maintain infection control by placing them on a dirty barrier after cleaning them. During an interview on 10/15/2021 at 3:48 PM, the clinical manager indicated all reusable supplies should be cleansed and then be put back into the nursing bag. She indicated hands should be cleaned before putting on gloves and after taking off gloves. 17-12-1(m) 1. Review of an agency policy, revised April 2021 and obtained 10/14/2021, titled "Standard Precautions," stated, "...Gloves are to be changed: 1. Between tasks and procedures on the same patient, 2. During changing or cleaning an incontinent patient, 3. After removing an old dressing ... Gloves are to be worn by the family/caregiver when direct contact with any body substance is anticipated (blood, urine, pus, feces, saliva, drainage of any kind.) ... Any nondisposable equipment or supply utilized by the clinician in the provision of care will be disinfected by thoroughly wiping down with an organization approved disinfectant before use with another patient. Examples would be but not limited to: ... 4. Nylon BP [blood pressure] cuffs, 5. Stethoscope." 2. Review of an agency policy, revised April 2021 and obtained 10/14/2021, titled "Hand Hygiene," stated, "... When hands are visibly dirty, contaminated with proteinaceous material, or are visibly soiled with blood or other body fluids, they should be washed with either a non-antimicrobial or antimicrobial soap and water. When hands are not visibly soiled, they should be washed using an alcohol-based hand rub for routinely decontaminating hands. ... Apply alcohol-based hand rub product to palm of one (1) hand and rub hands together, cover all surfaces of hands and fingers (including under nails) until hands are dry. ... Hand decontamination using an alcohol-based hand rub should be performed: A. Before having direct contact with patients, ... C. After contact with a patient's intact skin (when taking a pulse, blood pressure or lifting a patient), D. After contact with body fluids or excretions, mucous membranes, non-intact skin, and wound dressings, if hands are not visibly contaminated. E. When moving from a contaminated body site to a clean body site during patient care. F. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient. G. After removing gloves. ... Hand Washing with Soap and Water ... Wash hands for at least 20 seconds covering all surfaces of the hands and fingers ...." 3. Review of an agency policy revised April 2021 and obtained 10/14/2021, titled "Bag Technique," stated, "... 3. After hand washing, the supplies and/or equipment needed for the visit will be removed from the bag. 4. The bag will contain a designated clean and dirty area. The clean area contains unused or cleaned supplies/equipment, and the dirty area is designated for contaminated materials (i.e., used equipment, etc.). 5. When the visit is completed, reusable equipment will be cleaned using alcohol, soap and water, or other appropriate solution, hands will be washed, and equipment and supplies will be returned to the bag...." 4. During a home visit on 10/13/2021 at 10:02 AM, HHA [home health aide] E was observed providing care to patient #5. HHA E donned gloves without performing hand hygiene, then placed a barrier on patient #5's couch and set her bag on a barrier. HHA E took out supplies and placed them on the barrier. She took the patient's temperature, removed the sleeve from the thermometer, and then changed her gloves without performing hand hygiene. HHA E then checked patient #5's pulse and oxygen saturation, removed her gloves, pulled a pen from her pocket, and wrote the information on a paper towel. HHA E then used alcohol rub on the tops of her hands and palms of her hands only, donned new gloves and checked the patient's blood pressure. She then removed her gloves and wrote the blood pressure down on the paper towel. HHA E then went to patient #5's bathroom, brought back a bottle of liquid soap, and then retrieved more gloves from her bag without first performing hand hygiene. HHA E then used alcohol rub on the tops of her hands and palms of her hands (she did not use it between her fingers or on her thumbs), donned new gloves, brought in a folding table, and moved patient #5's bedside table over to the side. HHA E then reached into her bag while her gloves were still on and retrieved a clean barrier from the bag and placed the clean barrier on the bedside table. She then went to the patient's bathroom and returned with a basin of hot water. Patient #5's clothes, a towel, and one washcloth were laid on the couch out in preparation for the patient's bed bath. HHA E waited for the water to cool, but eventually went back to the patient's bathroom to add cool water to bring the temperature down, and brought the basin of water back. HHA E handed patient #5 the washcloth after wetting it so the patient could wash their own face, then the HHA took the cloth and washed the patient's ears. HHA E then wrung out the washcloth in the basin of water, added soap to the washcloth, and then proceeded to complete the rest of the bed bath using only one basin of water (no rinse water basin was used), one washcloth, and without changing the water. After the bed bath was complete, HHA E removed her gloves, used alcohol rub, then donned new gloves. She then retrieved a jar of skin cream as directed by the patient and began to apply the skin cream to patient #5's back & buttock area. HHA E then reached back into the jar for more skin cream, applied it to the patient's legs, then retrieved more cream from the jar and applied it to the patient's feet. HHA E then retrieved more skin cream from the jar and applied it to patient #5's abdomen, chest, right arm, and right hand. Then HHA E took more skin cream from the jar before applying it to the patient's left arm, left hand, lower abdomen, perineal area, upper thighs, and then down to the tops of the patient's legs. HHA E used the same pair of gloves each time she used the jar of skin cream and did not change her gloves or perform hand hygiene. After applying the skin cream, HHA E removed her gloves, reached into her bag, and applied alcohol rub to the tops of hands and palms of hands, and donned new gloves. She then took the clothes that were laid out and assisted the patient in getting dressed. After cleaning up the items from the bed bath, HHA E removed gloves, applied alcohol rub, donned new gloves, placed a small amount of alcohol rub on a paper towel and wiped her blood pressure cuff and stethoscope and placed them in her bag. She then gathered her garbage, took it to the garbage can, used alcohol rub on the tops of her hands and palms of her hands, and left the patient's home. During an interview on 10/15/2021 at 3:45 PM, the clinical manager indicated that agency employees should perform hand hygiene before touching anything in the patient home, between glove changes, and prior to leaving the patient home. The clinical manager indicated the home health aide should change the water while giving a bed bath. During an interview on 10/15/2021 at 3:48 PM, the clinical manager indicated the agency provides cleaning wipes to its employees for cleaning reusable supplies.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to maintain a program for identification, prevention, control and investigation of infectious and communicable diseases specific to care and services provided in the home setting The findings include: Review of an agency policy received on 10/14/2021 titled “Infection Control Plan,” revised April 2021, stated “ … To determine effectiveness of the infection control plan, Advanced Home Healthcare will measure, assess, improve and redesign (as appropriate) the surveillance, identification, prevention, ad control functionality through its performance improvement program….” During a home visit on 10/15/2021 for patient #3, the patient informed the nurse the physician had prescribed another round of antibiotics for her wound. She indicated she completed the 10-day treatment and the physician started her on another 14 day treatment Review of the agency's infection control binder failed to evidence documentation regarding patient's #3 antibiotic treatment for her wound. During an interview on 10/18/2021 at 11:41 AM, the clinical manager indicated the agency did not have an infection listed for the patient because she was unaware of the patient’s new antibiotic.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to provide patient and caregiver education and/or the correct education in 2 of 5 active clinical records reviewed. (#3, #4) The findings include: 1. An agency policy obtained 10/14/2021 titled “Scope of Services,” revised April 2021, stated “ … Professional nursing services are provided in accordance with the patient’s plan of care under the supervision of the registered nurse and include: … Counseling and educating the patient and family/caregiver regarding the disease process, self care techniques and prevention strategies….” 2. An agency policy received on 10/14/2021 titled “Care Planning Process,” revised April 2021, stated “ … patient and caregiver education and training that the organization will provide specific to the patient’s needs….” 3. An agency document titled “Physician Order” dated 10/4/2021, and digitally signed by RN (registered nurse) G stated, “pack left eye socket with moistened saline gauze twice per day.” During an interview on 10/18/2021 at 11:21 AM, the clinical manager indicated the home health agency was not going to the patient’s home twice a day for home care and the patient was doing the treatment twice per day. An agency document for patient #3 titled “RN Skilled Nursing Visit” dated 10/4/2021, and digitally signed by RN G failed to evidence teaching to the patient to pack the eye with moistened gauze. During an interview on 10/18/2021 at 11:30 AM, the clinical manager indicated she thought she had seen wound care education in the nurse’s note. The clinical manager failed to find the documentation in the patient record. 4. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled “Home Health Certification and Plan of Care,” for certification period 8/28/2021 - 10/26/2021, and digitally signed by RN F. This document evidenced an order for the wound vac to be changed three times per week and as needed. There was also an order to use a wet to dry dressing when the wound vac was not functioning. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled "RN Skilled Nursing Visit” dated 9/23/2021 and digitally signed by RN F. This document indicated the patient had a wound vac malfunction over night, removed the vac and applied a dry dressing to her wound. During an interview on 10/15/2021 at 3:17 PM, when queried about why the patient did a dry dressing when the wound vac malfunctioned, the clinical manager responded, “oh, well that’s not right." She indicated patient’s get taught and once they have they have mastered the teaching you can no longer see the documentation in the nursing visit notes. She was unable to locate teaching on using a wet to dry dressing if the wound vac malfunctioned.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the skilled nurse prepared clinical notes per the agency's policy in 1 of 5 active clinical records reviewed. (#4) The findings include: Review of an agency policy received 10/14/2021 titled "Scope of Services," revised April 202,1 stated "... Professional nursing services are provided in accordance with the patient's plan of care ... and include ... Preparing clinical and progress notes ... Rehabilitative therapies are provided according to the patient's plan of care ... and include: ... Preparing clinical and progress notes...." Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021 evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/28/2021 to 10/26/2021, digitally signed by RN (registered nurse) F. This document failed to evidence the patient’s diagnoses of Acute Kidney injury and necrotizing fasciitis. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled “RN-Skilled Nursing Visit” digitally signed by RN F and dated 10/1/2021. This document failed to evidence if patient #4’s wound had an odor. During an interview on 10/15/2021 at 3:25 PM, the clinical manager indicated wound documentation should contain measurements, and wounds should be assessed for drainage amount, color, and odor. 17-14-1(a)(1)(E)-RN

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to communicate with the physician and other health care practitioners in 1 of 5 active clinical records reviewed. (#4) The findings include: Review of an agency policy on 10/15/2021, titled "Pain Assessment," revised April 2021, stated "... Pain assessments will be documented in the clinical record, and information will be communicated to other caregivers…." Review of an agency policy on 10/15/2021, titled "Care Planning Process," revised April 2021, stated"... Clinicians will inform the patient's physician of any changes that suggest a need to alter the plan of care...." Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced agency documents titled “RN Skilled Nursing Visit” dated 8/30/2021, 9/6/2021, 9/13/2021, 10/11/2021, and digitally signed by RN (Registered Nurse) F. These documents indicated the patient's pain was rated 5 on a scale of 0-10 (where 0 is no pain and 10 is the most severe pain). Clinical record review failed to evidence RN F notified the physician of the patient's pain level. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled “RN Skilled Nursing Visit” dated 9/1/2021, and digitally signed by RN F. This document indicated the patient's pain was rated 7 on a scale of 0-10. Clinical record review failed to evidence RN F notified the physician of the patient's pain level. Clinical record review on 10/14/2021 for patient #4, start of care 8/28/2021, evidenced an agency document titled “RN Skilled Nursing Visit” dated 9/27/2021, and digitally signed by RN F. This document indicated the patient was experiencing edema (swelling) to both feet. Clinical record review failed to evidence RN F notified the physician of the patient's edema. During an interview on 10/15/2021 at 3:26 PM, the clinical manager indicated she would like to see, at the very least the patient was instructed to elevate her legs. The clinical manager stated “if the patient is having pain, then I would say we need to notify the physician. If it is consistent pain, but then goes up 2 numbers like from a 3-5 then they should be calling the physician.” 17-14-1(a)(1)(G)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to ensure the day-to-day operations of the home health agency. The findings include: Review of an agency policy received 10/14/2021, titled "Home Health Administrator," revised April 2021, stated "... The home health Executive Director/Administrator position will be responsible for the direction, coordination, and general supervision of all home health services. ... Responsibilities of the position will include but not be limited to: ... Planning, organizing, directing and evaluating operations to ensure the provision of adequate and appropriate care and services ... Complying with applicable law and regulations of operations ... Recruiting, employing, and retaining qualified personnel ... Directing and monitoring performance improvement activities ... Ensuring staff development including orientation, in-service education, continuing education ... Assuring the development and qualification for professional services and the assignment of personnel ... Ensuring the accuracy of public information materials ...." The administrator failed to ensure the day-to-day operations of the home health agency as evidenced by: The administrator failed to ensure the accuracy of all reported Oasis assessment data. Please see tag G0374. The administrator failed to ensure agency patients' received all services ordered in the plan of care. Please see tag G0436. The administrator failed to ensure the needs of agency patients were met. Please see tag G0534. The administrator failed to ensure the comprehensive assessment medication reconciliation was reviewed by a registered nurse. Please see tag G0536. The administrator failed to ensure the plan of care for agency patients was followed, individualized, and established by a primary care physician. Please see tag G0572. The administrator failed to ensure the plan of care contained all required elements. Please see tag G0574. The administrator failed to ensure all drugs, treatments, and services were only provided as ordered by a physician or other appropriate healthcare professional. Please see tag G0580. The administrator failed to ensure the primary care physician was promptly alerted to changes in the patients’ condition. Please see tag G0590. The administrator failed to ensure there was coordination of care amongst all agency disciplines and with outside healthcare entities who serviced agency patients. Please see tag G0606. The administrator failed to ensure there was a written visit schedule in all patient’s homes. Please see tag G0614. The administrator failed to ensure there was a written, current medication schedule in all patient’s homes. Please see tag G0616. The administrator failed to ensure all home health agency staff followed standard precautions to ensure the prevention and transmission of infectious and communicable diseases. Please see tag G0682. The administrator failed to ensure the home health agency maintained and coordinated an agency-wide program for the surveillance, identification, prevention, control and investigation of infections and communicable diseases. Please see tag G0684. The administrator failed to ensure all home health agency staff created clinical notes and/or accurate complete notes for all services provided to patients. Please see tag G0716. During an interview on 10/14/2021 at 2:36 PM, the administrator indicated he was not aware of any services not being provided by the agency. 17-12-1(c)(1)

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight for the coordination of referrals. The findings include: Review of an agency policy received on 10/14/2021, titled "Responsibilities/Supervision of Clinical Services" revised April 2021, stated " ... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Policies and procedures, which guide and support the provision of care and services, are developed and implemented ... The Clinical Director will oversee the day-to-day clinical operations...." Review of an agency policy received on 10/14/2021, titled "Referral Disclosure and Care Decisions" revised April 2021, stated, "... The referrals will be monitored, reviewed, and reported each month by the Program Director. ... The organization will accept only those patients ... who meet admission criteria. ... In compliance with standard medical practice, all services will be delivered under physician's (or other authorized licensed independent practitioner's) orders...." Clinical record review on 10/14/2021, for patient #6, start of care 7/29/2021, for certification period 7/29/2021 - 9/26/2021 evidenced an order from physician N for physical therapy services to evaluate and treat. Clinical record review on 10/14/2021, for patient #6, start of care 7/29/2021, failed to evidence the patient received any physical therapy services and failed to evidence the physician was informed in the delay of physical therapy services. During an interview on 10/18/2021 at 10:07 AM, the clinical manager indicated the patient was not sure if she wanted therapy so they were waiting for her to decide.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight and develop, implement and update the individualized plan of care in of 2 of 5 active clinical records reviewed. (# 1, #3 ) The findings include: 1. Review of an agency policy received on 10/14/2021, titled "Responsibilities/Supervision of Clinical Services," revised April 2021, "... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Policies and procedures, which guide and support the provision of care and services, are developed and implemented ... The Clinical Director will oversee the day-to-day clinical operations...." 2. Review of an agency policy titled "Care Planning Process," revised April 2021, stated "... A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. ... At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of care based upon the patient's identified needs and will review it with the patient and family/caregiver. ... The Clinical Supervisor or designee will review the plan of care for all patients...." 3. Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Physician Order” dated 9/2/2021, and digitally signed by RN [registered nurse] I. This document stated “Left lower leg wound: cleanse with NS, pat dry, cover wounds with adaptic [non adherent dressing], dry gauze, wrap with Kerlix secure with tape 3 times/ week. Left elbow wound: cleanse with NS [normal saline], pat dry, cover wounds with adaptic, dry gauze, wrap with Kerlix secure with tape 3 times/ week. Left hand wound cleanse with NS, pat dry, cover wounds with adaptic, dry gauze secure with tape 3 times/ week….” Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Physician Order” dated 9/2/2021, and digitally signed by RN I. This document stated “Beginning week of 9/12/2021 SN [skilled nurse] frequency 2w5 (twice a week for 5 weeks) 1w1 (once a week for one week) through the end of the certification period as wounds are healing, Wound care to be performed 2X (times)/week….” Clinical record review on 10/14/2021 for patient #1, start of care 8/22/2021, evidenced an agency document titled “Physician Order” dated 9/7/2021 and digitally signed by RN I. This document stated “Left buttock: cleanse area with NS, pat dry, cover with duoderm (wound dressing) every 3-5 days and PRN (as needed). Apply barrier cream with A &D ointment to peri area/ groin. Caregivers to apply with each diaper change….” Clinical record review for patient #1 failed to evidence the updated wound orders were added to the plan of care. During an interview on 10/18/2021 at 12:10 PM, the clinical manager indicated the plan of care should be updated to include any new orders for the patient. 4. Clinical record review on 10/14/2021 for patient #3, start of care 8/28/2021, evidenced an agency document titled “Physician Order” dated 9/17/2021 and digitally signed by RN G. This document stated “SN [Skilled Nurse] to perform wound care to left orbital socket twice a week. Clean orbital wound with NS, then pack with stripe [sic] of vigilon (non-adherent hydrogel dressing) then folded 2x2 dry gauze.” An agency document titled “Physician Order” dated 10/4/2021, and digitally signed by RN (registered nurse) G, stated “pack left eye socket with moistened saline gauze twice per day.” at An agency document titled “Home Health Certification and Plan of Care,” for certification period 8/28/2021 to 10/26/2021, evidenced a subsection titled “Orders and Treatments” which indicated the skilled nurse would see the patient once a week for one week and twice a week for eight weeks. This document failed to be evidenced as updated with the wound care orders. During an interview on 10/18/2021 at 11:20 AM, the clinical manager indicated the patient had the area sutured shut when they first went to see her. The orders were changed but she did not see them added to the plan of care.

An Emergency Preparedness survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Facility ID: 011167 Survey dates: 7/12/2021 - 7/15/2021 At this Emergency Preparedness survey, Advanced Home Health Care, Inc., was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

Establishment of the Emergency Program (EP) CFR(s): 484.102 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency: failed to develop and maintain a comprehensive emergency preparedness plan that is reviewed and updated at least every 2 years (see tag E0004); failed to develop and maintain a comprehensive emergency preparedness plan which included a documented, facility-based and community-based risk assessment utilizing an all-hazards approach and included strategies for addressing emergency events identified by the risk assessment (see tag E0006); failed to develop and maintain an emergency preparedness plan which included a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation (see tag E0009); failed to develop and implement individualized emergency preparedness plans for the patients which provided appropriate instructions, in the event of an emergency, to communicate with the agency (see tag E0017); failed to develop and implement emergency preparedness policies and procedures which included procedures to follow-up with on-duty staff and patients to determine services that are needed in the event there in an interruption in services during or due to an emergency and must inform State and local emergency preparedness officials about any on-duty staff or patients they are unable to contact (see tag E0021); failed to develop and implement emergency preparedness policies and procedures which included the use of volunteers or other emergency staffing strategies to address surge needs during an emergency (see tag E0024); failed to develop and maintain an emergency preparedness communication plan which included names and contact information for staff, patients' physicians, contracted entities and other agencies (E0030); failed to develop and maintain an emergency preparedness communication plan which included contact information for Federal, State, tribal, regional, and local emergency preparedness staff and other sources of assistance (see tag E0031); failed to develop and maintain an emergency preparedness communication plan which included a method for sharing information and medical documentation for patient's under the agency's care, as necessary, with other health providers to maintain the continuity of care and a means for providing information about the general condition and location of patients under the agency's care as permitted (see tag E0033); failed to develop and maintain an emergency preparedness communication plan which included a means of providing information about the agency's occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee (see tag E0034); failed to provide and maintain documentation of initial training and training every 2 years thereafter in emergency preparedness policies and procedures to all new and existing staff and individuals providing services under arrangement and failed to demonstrate staff knowledge of emergency procedures (see tag E0037) and failed to conduct an additional exercise of choice every 2 years, opposite the year of the full-scale exercise was conducted, to include, but not limited to, another full-scale or facility-based functional exercise, table top exercise, workshop or mock drill (see tag E0039). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with the condition 42 CFR 484.102 Emergency preparedness.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to review the emergency preparedness plan at least every 2 years. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Preparedness Plan" stated, "... The organization will comply with all applicable Federal, State, and local emergency preparedness requirements and will establish and maintain an emergency preparedness program that meets those regulations...." Review of the agency's emergency preparedness binder on 7/12/2021, failed to evidence when the emergency preparedness plan was last reviewed. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the governing body was responsible for reviewing the emergency preparedness plan. When queried on when was the last governing body meeting, the alternate administrator indicated it was in February 2021, and stated, "I don't specifically see that emergency preparedness was addressed or risk assessment completed, but Covid was." Requested the governing body minutes from the meeting in February 2021. No additional documents were provided.

Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. *[For LTC facilities at §483.73(a)(1):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a)(1):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a)(2):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to follow the agency's policy to annually evaluate the risk assessment. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Preparedness Plan" stated, "... Organization leadership will conduct a hazard vulnerability analysis (HVA) to identify potential emergencies (risks) ... The HVA is evaluated annually to reflect changes in organization, risk conditions, patient information and changes in staff...." Review of the agency's emergency preparedness binder on 7/12/2021, evidenced an agency document titled "Hazard and Vulnerability Assessment Tool", dated December 2015. Review indicated the event type "Epidemic" was rated a low probability. Review failed to evidence the agency followed its policy and annually re-evaluated its risk assessment to include the current pandemic of Covid-19. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated there was no risk assessment completed since the document dated December 2015, and stated, "Yes, it should have been updated to reflect the current pandemic."

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years (annually for LTC facilities). The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure an emergency preparedness plan was developed and maintained to include a process for cooperation and collaboration with local, regional, State and Federal emergency preparedness officials' and efforts were made to maintain an integrated response during a disaster or emergency preparedness. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Preparedness Plan" stated, "... The organization will comply with all applicable Federal, State, and local emergency preparedness requirements and will establish and maintain an emergency preparedness program that meets those regulations. ... Staff will work with regional or county emergency management planning agencies...." Review on 7/12/2021, of the agency's emergency preparedness binder failed to evidence a process and collaboration with local, regional, State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency preparedness. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the agency did not have a defined process for or documentation of cooperation and collaboration with local, regional, State and Federal emergency preparedness officials. The alternate administrator indicated the agency did meet once in the past with the local fire chief and stated, "He told us the best thing we can do is stay out of their way."

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: 6. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care", electronically signed by RN [Registered Nurse] L , which stated, "... Emergency Plan Developed...." Clinical record review failed to evidence an emergency plan was developed for patient #1. During an interview on 7/15/21 at 3:55 PM, the clinical manager indicated there should be an emergency plan. 7. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care", electronically signed by RN [Registered Nurse] L , which stated, "... Emergency Plan Developed...." Clinical record review evidenced an agency document titled "Emergency Plan." This document failed to evidence the phone numbers of patient #3's physician and close relatives and friends. The plan also failed to include the information and phone number for Center P [dialysis center]. The agency failed to provide an emergency plan that addressed patient #3's need for dialysis. 8. Clinical record review on 7/13/2021 for patient #4, start of care 5/30/2020, evidenced an agency document titled "Home Health Certification and Plan of Care", electronically signed by RN L , which stated, "... Emergency Plan Developed...." Clinical record review failed to evidence an emergency plan was developed for patient #4. 9. Clinical record review on 7/14/2021 for patient #5, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care", electronically signed by RN L , which stated, "... Emergency Plan Developed...." Clinical record review failed to evidence an emergency plan was developed for patient #5. During an interview on 7/15/21 at 3:55 PM, the alternate clinical manager indicated she did not see the plan for the patient and would reach out to the clinical manager, no further information was provided as of the exit conference on 7/15/21. Based on record review and interview, the agency failed to develop and implement individualized emergency preparedness plans for the patients which provided appropriate instructions, in the event of an emergency, in 8 of 8 clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7, #8) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Emergency Management Plan" stated, "... Individualized plans for patients during a natural or man-made disaster will be included as part of the comprehensive patient assessment...." Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Admission Documents" stated, "... [Agency] will provide written admission documents prior to or at initiation of home care services including: ... Information addressing emergency management ... Appropriate documents will be included in an admission folder ... The admission information will be left in the patient's home...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, failed to evidence an individualized emergency preparedness plan. During an interview on 7/14/2021 at 3:51 PM, the office coordinator indicated the patient did not have an individualized emergency preparedness plan. 3. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, failed to evidence an individualized emergency preparedness plan. During an interview on 7/13/2021 at 4:07 PM, office coordinator D indicated registered nurse L did not complete an individualized emergency plan for the patient. During an interview on 7/13/2021 at 4:07 PM, the clinical manager indicated the individualized emergency preparedness plan for the patient was not located. 4. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Emergency Plan", dated 12/29/2020, and signed by the patient. Review failed to evidence the name of the patient's emergency contact on the individualized emergency preparedness plan. During an interview on 7/13/2021 at 4:49 PM, the clinical manager indicated the name of the patient's emergency contact was not included on the patient's emergency plan but it should be. 5. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, failed to evidence an individualized emergency preparedness plan. During an interview on 7/13/2021 at 3:21 PM, the clinical manager said there was not an individualized emergency preparedness plan for the patient.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years.] At a minimum, the policies and procedures must address the following:] (3) The procedures to follow up with on-duty staff and patients to determine services that are needed, in the event that there is an interruption in services during or due to an emergency. The HHA must inform State and local officials of any on-duty staff or patients that they are unable to contact. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement emergency preparedness policies and procedures which included procedures to inform State and local emergency preparedness officials about on-duty staff or patients the agency was unable to contact. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... The plan includes the following: ... A means of informing state and local emergency preparedness officials before, during and after an emergency on the following: Patients that the organization has been unable to contact to determine service needs...." Review on 7/12/2021, of an undated agency document titled "Emergency Preparedness Plan" stated, "... Objectives ... To coordinate Agency staff members in patient care and evaluation, as well as any Agency personnel assistance with care of those in the community who are affected by the emergency...." Review failed to evidence the emergency preparedness plan included the process for reporting to State and local officials of any on-duty staff or patients the agency was unable to contact. Review failed to evidence contact information for local and State emergency preparedness officials. During an interview on 7/12/2021 at 3:14 PM, the alternate clinical manager indicated the emergency preparedness plan doesn't say how we are going to do that, just that we have to notify local and State officials.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years (annually for LTC).] At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the emergency preparedness policies and procedures included the use of volunteers or other emergency staffing strategies to address surge needs during an emergency. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... Staff will work with regional or county emergency management planning agencies, where available, in: ... Defining ... the organization's surge capacity ...." Review failed to evidence the emergency preparedness policies included the use of volunteers or other emergency staffing strategies to address surge needs during an emergency. Review on 7/12/2021, of the agency's emergency preparedness plan failed to evidence the agency's plan for emergency staffing during an emergency. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the agency had an agreement with another agency regarding staffing. The alternate administrator could not remember the agency's name and indicated she would look for the agreement. At 4:50 PM, the alternate administrator indicated home care agency O was the agency with whom there was a staffing agreement. Requested the agreement. No additional documentation provided. During an interview on 7/15/2021 at 10:10 AM, the alternate clinical manager indicated she believed the agreement was verbal and not written with agency O. No further additional documentation provided.

Names and Contact Information CFR(s): 484.102(c)(1) [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included names and contact information for staff, entities providing services under arrangement, patients' physicians, volunteers and other agencies. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... The plan includes the following: 1. Names and contact information for the following: A. Staff B. Entities providing services under arrangement C. Patients' physician...." Clinical record review for patient #3 evidenced the patient received dialysis services at dialysis center P. Review of an undated agency document titled "List of Contractors" indicated therapy company C and social work company D provided contracted services to the agency. During an interview on 7/12/2021 at 4:50 PM, the alternate administrator indicated home care agency O was the agency with whom there was a staffing agreement. Review on 7/12/2021, of the agency's emergency preparedness binder failed to include the contact information for dialysis center P, therapy company C and social work company D. Review failed to evidence the contact information for the patients' physicians and home care agency O. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the communication plan should include the contact information for therapy company C and social work company D and should include the contact information for the dialysis centers from which their patients receive services.

Emergency Officials Contact Information CFR(s): 484.102(c)(2) [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following: (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. *[For LTC Facilities at §483.73(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) The State Licensing and Certification Agency. (iii) The Office of the State Long-Term Care Ombudsman. (iv) Other sources of assistance. *[For ICF/IIDs at §483.475(c):] (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (iii) The State Licensing and Certification Agency. (iv) The State Protection and Advocacy Agency. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included contact information for Federal, State, tribal, regional, and local emergency preparedness staff and other sources of assistance. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... The plan includes the following: ... Contact information for the following: A. Federal, state, tribal, regional and/or local emergency preparedness agencies...." Review on 7/12/2021, of the agency's emergency preparedness binder failed to evidence the contact information for federal, state, regional and local emergency preparedness agencies. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated there was no contact information for federal, state, regional and local emergency preparedness agencies in the emergency preparedness plan.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility's] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility's] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI's care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included a method for sharing information and medical documentation for patient's under the agency's care, as necessary, with other health providers to maintain the continuity of care and a means for providing information about the general condition and location of patients under the agency's care as permitted. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... The plan includes the following: ... A method for sharing information and medical documentation for patients under the organization's care as permitted...." Review on 7/12/2021, of the agency's emergency preparedness binder failed to evidence the communication plan included a method for sharing information and medical documentation for patient's under the agency's care with other health care providers. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the emergency preparedness plan did not include a method for sharing information and medical documentation for patient's under the agency's care with other healthcare providers.

Information on Occupancy/Needs CFR(s): 484.102(c)(6) [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years (annually for LTC).] The communication plan must include all of the following: (7) [(5) or (6)] A means of providing information about the [facility's] occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For ASCs at 416.54(c)]: (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. *[For Inpatient Hospice at §418.113(c):] (7) A means of providing information about the hospice's inpatient occupancy, needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and maintain an emergency preparedness communication plan which included a method for sharing information and medical documentation for patient's under the agency's care, as necessary, with other health providers to maintain the continuity of care and a means for providing information about the general condition and location of patients under the agency's care as permitted. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The organization will maintain an emergency preparedness communication plan that complies with Federal, State, and local laws ... The plan includes the following: ... A means of providing information about the organization's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee...." Review on 7/12/2021, of the agency's emergency preparedness binder failed to evidence the communication plan included a method for providing information about the organization's needs and its ability to provide assistance to the authority having jurisdiction in the event of an emergency. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the emergency preparedness plan did not include a method for providing information about the agency's needs and its ability to provide assistance to the authority having jurisdiction.

EP Training Program CFR(s): 484.102(d)(1) *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide and maintain documentation of initial training and every 2 years thereafter in emergency preparedness policies and procedures to all new and existing staff and individuals providing services under arrangement and failed to demonstrate staff knowledge of emergency procedures. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... The training includes: initial training in emergency preparedness policies and procedures and their assigned emergency response roles to all new and existing staff, individuals providing service under arrangement ... The training is provided annually and demonstrates staff knowledge of emergency procedures. Organization leadership will provide for orientation and annually thereafter of all personnel regarding participation in the emergency management plan...." Personnel record review on 7/13/2021, for the administrator, date of hire 6/9/2014, clinical manager date of hire 11/10/2014, alternate clinical manager, date of hire 5/4/2021, office coordinator D, date of hire 2/15/2021, licensed practical nurse (LPN) F, date of hire 10/22/18, contracted physical therapy assistant O, date of hire 4/6/18 and contracted occupational therapist K, date of hire 2/27/10 failed to evidence training in emergency preparedness policies and procedures to include demonstration of staff knowledge of emergency procedures. Review of an agency binder on 7/13/2021, titled "Inservices" evidenced agency documents titled "CHAP [Community Health Accreditation Partner] - List of Annual Inservices for field staff" which indicated emergency preparedness was included in the annual inservices. Review failed to evidence a document for RN B, RN C, LPN F, PTA O and OT K indicating receipt of emergency preparedness training. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated emergency preparedness training was to be provided at time of hire and annually in September. During an interview on 7/13/2021 at 12:24 PM, the alternate administrator indicated if staff was as needed (PRN) or part time, staff received their emergency preparedness training at home care agency A and not at Advanced Home Care and if staff was contracted, staff received their training from the owner of therapy agency C. The alternate administrator indicated there was no emergency preparedness training for LPN F and office coordinator D. During an interview on 7/14/2021 at 2:24 PM, when queried about what training had been provided by the agency for emergency preparedness, home health aide H indicated she knew to call the supervisor but then would call the scheduler or the alternate administrator.

EP Testing Requirements CFR(s): 484.102(d)(2) *[For RNCHI at §403.748, ASCs at §416.54, HHAs at §484.102, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHC at §485.920, RHC/FQHC at §491.12, ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility- based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d) (2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility- based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct an additional exercise of choice every 2 years, opposite the year the full-scale exercise was conducted, to include, but not limited to, another full-scale or facility-based functional exercise, table top exercise, workshop or mock drill. The findings include: Review of an agency policy, revised November 2017 and obtained 7/12/2021, titled "Emergency Management Plan" stated, "... Advanced Home and Healthcare, Inc will test the emergency management plan at each site included in the plan, at least annually, either in response to an actual emergency or in a planned exercise. ... In the event an actual natural or man-made emergency occurred, the agency will be exempt for 1 year following the onset of the actual event. An additional exercise is conducted and may include, but not limited to: A second full-scale exercise that is community-based or individual facility-based, or a table-top exercise...." Review on 7/12/2021, of the agency's emergency preparedness binder evidenced an actual emergency occurred in April 2019, involving the electronic health record, in March 2020, involving the Covid-19 pandemic and on 2/15/2021, in response to extreme snowfall thus activating the the agency's emergency plan. Review failed to evidence an additional exercise was conducted every 2 years. During an interview on 7/12/2021 at 3:14 PM, the alternate administrator indicated the annual cycle for emergency preparedness testing was January to December and indicated there were no planned emergency preparedness exercises, but rather the agency used the the actual emergency situations for the agency's exercises since they happened. The alternate administrator stated, "So we have to have another exercise? I just thought it was one a year."

This survey was a Federal Re-certification and focused Infection Control survey for a home health agency. Survey Dates: 7/12/2021 - 7/15/2021 Facility ID: 011167 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Advanced Home Health Care, Inc. is precluded from providing its own home health aide training and competency evaluation for a period of two years from 07/15/2021 - 07/15/2023, due to being found out of compliance with Conditions of Participation 484.60 Care Planning, Coordination of Care and Quality of Care, 484.65 Quality Assessment and Performance Improvement, 484.102 Emergency Preparedness and 484.105 Organization and Administration of Services. Quality Review Completed 08/09/2021

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the Oasis was completed, accurate and reflected the patient's current status in 5 of 8 complete clinical records reviewed (#2, #5, #6, #7, #8) and 2 of 2 partial clinical records (#9, #10) reviewed. The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "OASIS Data Transmission" stated, "... All OASIS data items must be complete ... The encoded OASIS data must accurately reflect the patient's status at the time of assessment...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Initial and Comprehensive Assessment" stated, "... The assessment will be patient-specific and comprehensive to include the patient's need for home care ... During the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient's progress towards goals and other relevant information will be documented in the patient's clinical record, including at least the following information, if applicable: A. Outcomes and Assessment Information Set (OASIS) data must be collected on all patients receiving skilled services ... The OASIS data will be collected during the comprehensive assessment. B. A physical assessment, including temperature, pulse, respiration, skin, pain status, height/weight, nutritional status, and other relevant data related to pertinent physical findings. C. Patient's functional status, including but not limited to, the degree of self-care, and the amount and level of assistance needed ... D. Patient's medical and psychosocial history, including pertinent diagnosis and prognosis ... T. Preventative and periodic health screening ... Immunizations...." 3. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient had a history of falls and required assistance with ambulation and failed to evidence the fall risk assessment was complete. Review indicated the patient was incontinent (loss of control) of bowel and bladder and dependent for dressing and toileting, and the document indicated the patient was instructed to change his adult incontinent briefs often. Review failed to evidence the education reflected the patient's status. During an interview on 7/15/2021 at 12:50 PM, the alternate clinical manager stated, "It doesn't seem like an appropriate intervention based on patient assessment." 4. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021, and digitally signed by RN L. This document failed to evidence a complete risk assessment to include the shingles vaccination status and health screening. 5. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "OASIS-D1 Recertification", dated 2/26/2021, and digitally signed by registered nurse I, which failed to be complete and evidence the patient's height and weight. This OASIS document failed to evidence the follow-up self-care assessment. 6. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/12/2021, and digitally signed by registered nurse E. This document failed to evidence a complete risk assessment to include the shingles vaccination status and health screening. 7. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021, and digitally signed by RN L. This document failed to evidence a complete risk assessment to include the shingles vaccination status and health screening. The OASIS document indicated the nose was not assessed and failed to evidence a complete document. 8. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021, and digitally signed by RN L. This document failed to evidence a complete risk assessment to include the shingles vaccination status and health screening. 9. During an interview on 7/13/2021 at 3:30 PM, the clinical manager stated, "We've told staff to complete all sections." At 4:11 PM, the clinical manager indicated the OASIS assessment should be complete. 10. Clinical record review on 7/13/21 for patient #5, start of care 5/10/21, evidenced an agency document titled "OASIS D-1 Start of Care." This document had a subsection titled "(M1021 Primary Diagnosis & (M1023) Other Diagnosis), " which stated, " ... Pressure-induced deep tissue damage of right ankle Pressure-induced deep tissue damage of unspecified buttocks Non prs [pressure] chronic ulcer [open sore] of site w with fat tissue exposed...." This document failed to have the patient's correct and current diagnoses listed. Clinical record review of patient #5's electronic record failed to evidence any wounds or pressure ulcers documented for patient #5. During an interview on 7/15/21 at 3:41 PM, RN E indicated when the patient was assessed for the start of care, he had no wounds or pressure sores. She indicated these diagnoses were not accurate at time of assessment.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: 7. Clinical record review on 7/14/2021 for patient #5, start of care 5/10/21, and a primary diagnosis of Hypertension [high blood pressure] evidenced an agency document titled "OASIS-D1 Recertification", dated 3/31/2021, and digitally signed by RN E. This document indicated the patient was incontinent [loss of control] of bowel and bladder, had difficulty with ambulation, shortness of breath, needs assistance with dressing, and was at risk for falls. This document indicated the patient was to receive skilled nursing services twice a week for four weeks, once a week for five weeks. Physical and occupational therapy once a week for one week. Review failed to evidence the patient was informed and consented to the care to be provided, the frequency of visits, and failed to evidence the patient participated in and was informed of the plan of care. During an interview on 7/15/21 at 2:25 PM, the alternate clinical manager indicated she could not find consent in the clinical record, but would check with the clinical manager. No further information was provided as as of the exit conference on 7/15/2021. 8. Clinical record review on 7/14/21 for patient #4, start of care 5/30/20, evidenced an agency document titled "Home Health Certification Plan of Care," signed by RN E dated 5/24/21, and signed by physician G. Diagnoses included but not limited to Type 2 diabetes mellitus [high blood sugar] with diabetic chronic kidney disease[ability to filter waste from the body], hypertensive [high blood pressure] chronic kidney disease, chronic kidney disease stage 4, type 2 diabetes[high blood sugar] with diabetic peripheral angiopathy [blood vessel disease] without gangrene [dead tissue] Type 2 diabetes with diabetic neuropathy [causes weakness and numbness], intervertebral disc displacement, lumbar region [lower back], asthma [breathing problem], hypothyroidism [glad does not produce enough of thyroid hormone] , major depressive disorder, single episode, sleep apnea [sleep disorder where breathing starts and stops] , long term use of hypoglycemic drugs, history of falling. A subsection titled "Orders and Treatments" stated " ... SN [skilled nurse] to perform head to toe assessment including but not limited to the following: Mental Status, Nutrition/Hydration status Cardiovascular Status, Respiratory Status, Safety, Medications, S/Sx of Infection, Pain and Vital Signs ... SN to instruct on all aspects of Diabetes management to include disease process, foot assessments, signs and symptoms of hypo/hyperglycemia, glucometer use and preparation and administration of diabetic medications ordered by physician SN to instruct patient on non pharmacological pan relief including relaxation techniques, massage, stretching, positioning, and/or hot/cold pack SN to assess for skin break down every visit SN to instruct patient on methods to reduce friction and sheer SN to instruct patient to float heels...." Clinical record review of patient #4's electronic record failed to evidence patient #4 was informed of and consented to the treatment to be provided in the plan of care. During an interview on 7/15/21 at 3:27 PM, the alternate clinical manager indicated the patient was informed and consented to the care to be provided. She was unable to locate consent in the clinical record. 9. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21, and electronically signed by RN L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]..." This document had an area subtitled "Orders and Treatments" which stated " SN 2xwk/1wk; 4xwwk[sic]/4wks; 3xwk/4wks...." Clinical record review of patient #1's electronic record failed to evidence patient #4 was informed of and consented to the treatment to be provided in the plan of care. During an interview on 7/14/21 at 1:26 PM, the clinical manager indicated the patient was informed and consented to the care to be provided. She was unable to locate consent in the clinical record. 10. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type 2 diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had an area subtitled "Orders and Treatments" which stated "SN 2xwk/ 1wk; 1xwk/8wks & 2 PRN for catheter problems, PT [physical therapy] 1x/1wk to begin wk of 5/17/21 OT [occupational therapy] 1x1wk to begin week 5/17/21 ... OT Evaluation and treatment. OT plan and treatment will be developed in collaboration with the physician after the Evaluation visit is completed ... PT Evaluation and treatment. PT plan and treatment will be developed in collaboration with the physician after the Evaluation visit is completed...." Clinical record review of patient #1's electronic record failed to evidence patient #3 was informed of and consented to the treatment to be provided in the plan of care. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated the patient was informed and consented to the care to be provided. She was unable to locate consent in the clinical record. 17-12-3(b)(2)(D)(ii)(AA) and (BB) 17-12-3(b)(2)(D)(iii) Based on record review and interview, the agency failed to ensure the patient / caregiver consented to in advance, the changes in the frequency of services that were being furnished in 8 of 8 complete clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7, #8) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Patient Bill of Rights" stated, "... Each patient will be an active, informed participant in his/her plan of care. ... The Patient Bill of Rights statement defines the right of the patient to: ... Be advised in advance of the right to participate in planning the care of service and in planning changes in the care and service...." 2. Clinical record review on 7/15/2021 for patient #2, start of care 5/1/18, evidenced agency documents titled "HHA Visit", digitally signed by HHA [home health aide] H, which indicated the patient received HHA services to include personal care and ADL [activities of daily living] assistance on 4/15/2021, 4/22/2021, 4/29/2021, 5/6/2021, 5/13/2021, 5/20/2021, 5/27/2021 and 6/3/2021. Review evidenced an agency document titled "Admission Consent", dated 5/1/18, and signed by the patient, which failed to evidence the patient was informed of and consented to home health aide services. 3. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "Admission Consent", dated 6/25/2021, and signed by the patient's representative and registered nurse L. This document indicated the patient was informed of and consented to physical therapy (PT) services 1 time a week for 1 week. Review of an agency document titled "PT Evaluation", dated 6/28/2021, and digitally signed by PT G, indicated the patient was to receive PT 2 times a week for 4 weeks. Review failed to evidence the patient/representative was informed of and consented to the change in frequency of PT services. During an interview on 7/13/2021 at 4:07 PM, the clinical manager indicated she did not see the patient had been notified of the change in frequency of PT services. 4. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Admission Consent", dated 12/29/2020, and signed by the patient's representative and registered nurse I. This document indicated the patient was informed of and consented to PT and occupational therapy (OT) evaluations. Review of an agency document titled "PT Evaluation", dated 1/4/2021, and digitally signed by PT G, indicated the patient was to receive PT 2 times a week for 4 weeks. Review failed to evidence the patient/representative was informed of and consented to the change in frequency of PT services. Review of an agency document titled "Occupational Therapy Evaluation", dated 1/6/2021, and electronically signed by OT K, indicated the patient was to receive OT 1 time a week for 1 week, then 2 times a week for 4 weeks and then 1 time a week for 3 weeks. Review failed to evidence the patient/representative was informed of and consented to the change in frequency of OT services. 5. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, evidenced an agency document titled "Admission Consent", dated 4/12/2021, and signed by the patient and registered nurse E. This document indicated the patient was informed of and consented to a PT evaluation. Review of an agency document titled "Physical Therapy Evaluation", dated 4/21/2021, and electronically signed by PT N, indicated the patient was to receive PT services 1 time a week for 1 week and then 2 times a week for 7 weeks. This document indicated the patient's goals included improve sit to stand transfer, improve bed to chair transfer, improve standing, to walk up to 350 feet with rolling walker and improve muscle strength to lower extremities. This document failed to evidence the patient was informed of and consented to the change in physical therapy frequency and informed of the PT goals. 6. During an interview on 7/13/2021 at 3:20 PM, the clinical manager indicated the therapist should talk to the patient about the evaluation and document the communication on the evaluation note. At 4:49 PM, the clinical manager indicated the consent form should have been updated to reflect the change in PT and OT services and the patient's consent to the changes.

Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure patients received all services documented in the plan of care in 5 of 8 complete clinical records (#1, #3, #5, #6, #7) and 2 of 2 partial clinical records (#9, #10) reviewed. The findings include: 1. An agency policy titled "Scope of Services," with a revision date of November 2017, stated " ... 1. Professional nursing services are provided in accordance with the patient's plan of care, under the supervision of a registered nurse and include: ... B. Initiating the plan of care and revising when necessary C. Providing those services and/or treatments requiring substantial and specialized nursing skill D. Counseling and educating the patient and family/caregiver regarding the disease process, self-care techniques, and prevention strategies ... H. Referral to other services as needed I. Informing the physician and other staff of changes in the patient's needs...." 2. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, the diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]..." This document had an area subtitled "Orders and Treatments" which stated " ... SN [Skilled Nursing] 2xwk/1wk [two times a week for 1 week] 4xwwk/4wks [4 times a week for 4 week], 3xwk/4wk [3 times a week for 4 weeks...." Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, for certification period 6/9/2021 - 8/7/2021, failed to evidence patient #1 was was seen by the skilled nurse 4 times per week for the weeks 6/13/2021- 6/19/2021, 6/20/2021 - 6/26/2021, 6/27/2021 - 7/3/2021 and 7/4/2021 - 7/10/2021. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021. This document had an area subtitled "Orders and Treatments" which stated "Wound care included cleansing with betadine [antiseptic] packing iodoform [antiseptic dressing] strip and cover with DSD [dry sterile dressing] wound care to be done every other day...." Clinical Record review on 7/13/3021 for patient #1, evidenced patient #1 received wound care on 6/13/2021, 6/15/2021, 6/23/2021, 6/25/2021, 6/29/2021, 7/2/2021, 7/5/2021, and 7/7/2021. Clinical record review failed to evidence the patient received all of the wound care visits as ordered on the plan of care. 3. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type two diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body properly]...." This document had an area subtitled "Orders and Treatments" which stated "SN 2xwk/1wk [twice a week for one week; 1xwk/8wks [once a week for eight weeks] & 2 PRN [as needed] for catheter problems, PT [physical therapy] 1x/1wk [once a week for one week] to begin wk of 5/17/21 OT [occupational therapy] 1x1wk to begin week 5/17/21 ... OT Evaluation and treatment. OT plan and treatment will be developed in collaboration with the physician after the Evaluation visit is completed ... PT Evaluation and treatment. PT plan and treatment will be developed in collaboration with the physician after the Evaluation visit is completed...." Clinical record review for patient #3, start of care 5/10/2021, for certification period 5/10/2021 - 7/8/2021 failed to evidence the patient was seen by occupational therapy and physical therapy for an evaluation and a treatment plan to be developed. During an interview on 7/14/2021 at 9:52 AM , Person E (spouse of patient 3) indicated they are just waiting on the therapist to call and set up an appointment to begin services. She indicated she had not heard from the therapist yet and she let home health agency know that he needs therapy. During an interview on 7/14/2021 at 4:01 PM, the clinical manager indicated therapy was unable to reach the patient to schedule services. The clinical manager indicated therapy made multiple calls, the calls were unanswered, and the therapist was unable to leave a message. 4. Clinical record review on 7/13/2021 for patient #5, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, primary diagnosis of Essential Primary Hypertension [high blood pressure] ... This document had an area subtitled "Orders and Treatments" which stated "SN 2w4 [twice per week for four weeks], 1w5 [once a week for 5 weeks] ...." Clinical record review for patient #5 start of care 5/10/2021, for certification period 5/10/2021 - 7/8/2021 failed to evidence patient #5 was seen by skilled nursing twice the week of 5/16/2021 - 5/22/2021 and once the week of 6/6/2021 - 6/12/2021 as ordered on the plan of care. During an interview on 7/15/2021 at 2:15 PM, the alternate clinical manager indicated she was not sure why visits were not completed there was no documentation in the computer, as to why the visits were missed. 5. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021. This document indicated the patient's diagnoses included, but were not limited to, Stage III pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in full thickness skin loss) to the right heel, fracture to the right tibial tuberosity (a bone in the lower leg) and chronic pain. This document indicated the patient was to receive physical therapy (PT) and occupational therapy services 1 time a week for 1 week for an evaluation and the document stated, "... Measures to address risk for ER [emergency room]/Hospitalization: ... Pain control ...." Review failed to evidence OT services had been provided as directed in the plan of care. During an interview on 7/13/2021 at 3:55 PM, the clinical manager indicated therapy should evaluate the patient within 5 days of assessment and OT had not yet evaluated the patient. Review of an agency document titled "PT Visit", digitally signed by PT G and dated 7/1/2021, indicated the PT assessed the patient to have pain to the right knee, but failed to assess the patient's level of pain before and after therapy. During an observation of care at the patient's home on 7/14/2021 at 4:18 PM, the patient was observed with a dressing wrapped around the right foot. PT G was observed assisting patient with lower body exercises, assisting patient to ambulate using the walker and assisting the patient to climb up and down stairs. PT G was not observed to have assessed the patient's wound prior to conducting PT services. During an interview on 7/13/2021 at 3:58 PM, the clinical manager indicated therapists should assess for pain before therapy treatment. 6. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021 and signed by registered nurse I and the physician. This document indicated the patient was to receive home health aide services 2 times a week for 8 weeks and then 1 time a week for 1 week beginning the week of 2/28/2021. Review indicated the patient received home health aide services 3 times during week 4 beginning 3/21/2021 and 1 time during week 5 on 3/31/2021. Review failed to evidence home health aide services were provided after 3/31/2021 and failed to evidence home health aide services were provided as directed in the plan of care. This document indicated the physician orders included the patient to be seen for an OT (occupational therapy) evaluation but review failed to evidence OT therapy services for an evaluation were provided as directed in the plan of care. During an interview on 7/13/2021 at 4:30 PM, the clinical manager indicated the last home health aide visit was on 3/31/2021, because the home health aide "fell off the face of the Earth." At 4:48 PM, the clinical manager indicated OT discharged the patient on 2/11/2021, but maybe the patient needed to be evaluated for additional OT services. 7. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021 and digitally signed by RN L, which indicated the patient's diagnoses were Parkinson's disease and hypertension (high blood pressure). Review evidenced the patient lived alone, ate mostly frozen meals and a referral was needed to a medical social worker (MSW) for housing choices. Review indicated the patient was at risk for falls and had difficulty with ambulation, limited mobility and poor balance. The document stated, "... has frequent falls. She lives in 1 room of a house ... has to climb 4 stairs to garage to access the refrigerator and microwave...." Review indicated the agency services were to include skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/15/2021 - 8/13/2021, signed and dated by the nurse practitioner on 7/15/2021, indicated the orders for services included skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review failed to evidence the patient had received any skilled nursing, PT, OT and MSW services as ordered on the plan of care. During an interview on 7/15/2021 at 2:22 PM, the alternate clinical manager indicated the agency was unable to reach the patient and staff should contact the clinical manager when unable to contact the patient "so it's on our radar." The alternate clinical manager indicated sometimes the agency will call the local authorities to conduct a well visit when unable to reach a patient but it was not agency policy that it had to be done. During an interview on 7/15/2021 at 2:24 PM, office coordinator D indicated she just received an email from therapy company C regarding communication with the patient and a scheduled PT evaluation. Office coordinator indicated she had just entered the information into the clinical record regarding the message from therapy agency C. Review of an agency document titled "Patient Notes/Messages", dated 7/15/2021, and entered by office coordinator D, indicated there was a therapy services update and noted a document attachment. Review of an agency document titled "Narrative Note", dated 7/7/2021, and electronically signed by PT P, which indicated therapy company C had difficulty reaching the patient to schedule initial PT evaluation, but was now scheduled for 7/15/2021. Review failed to evidence any communication regarding PT services until communication with therapy agency C on 7/15/2021. During an interview on 7/15/2021 at 2:24 PM, when queried why the agency had made patient contact but the agency had not, the alternate clinical manager indicated a missed visit note in the clinical record on 6/30/2021 indicated the nurse attempted to call the patient but there was no answer. The alternate clinical manager indicated there was no communication from the agency regarding attempts to contact the patient since 6/30/2021. At 2:35 PM, the alternate clinical manager indicated office coordinator D usually sent the referrals for MSW services and indicated there was no communication regarding MSW services for the patient. The alternate clinical manager asked office coordinator D if a MSW referral was sent to agency D, office coordinator D stated, "No one has told me to contact [agency D] for a MSW referral." 8. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021 and digitally signed by RN L. This document indicated the patient's diagnoses included, but were not limited to: neck muscle strain, right lower leg contusion (bruise), Parkinson's disease, spinal stenosis (narrowing of the spaces within the spine putting pressure on the nerves) and diabetes (a chronic disease affecting how the body uses blood sugar). Review indicated the patient was at risk for falls, had difficulty with ambulation requiring the use of a cane and had poor balance. This document indicated the patient required assistance with dressing the lower body and bathing and stated, "... [patient] has not been taking a shower last few months, gait to [sic] unsteady and no one to assist him ... Has several stairs leading outside, he fell yesterday down these stairs; needs assistive device and assist to leave home ...." Review indicated the patient was to receive home health aide services 1 time a week for 9 weeks. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 4/15/2021 - 6/13/2021, signed and dated by the physician on 4/21/2021, indicated the orders for agency services included home health aide services 1 time a week for 9 weeks. Review failed to evidence the patient had received any home health aide services as ordered in the plan of care. During an interview on 7/15/2021 at 5:05 PM, the alternate clinical manager indicated there was no record of home health aide services provided to the patient and no communication in the record why home health aide services were not provided.

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview,the agency failed to ensure the comprehensive assessment was completed within 30 calendar days after the start of care in 1 of 2 closed clinical records reviewed. (#7) The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Initial and Comprehensive Assessment" stated, "... A comprehensive patient assessment will be completed within five (5) calendar days of the patient's start of care...." Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Availability of Services" stated, "... Additional discipline initial assessments will be provided within five (5) business days of the start of care or date of the physician's (or other authorized licensed independent practitioner's) order...." Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, and signed by registered nurse I and the physician. This document indicated the physician orders included the patient was to be seen for an OT (occupational therapy) evaluation but review failed to evidence the patient had a comprehensive assessment for OT services. During an interview on 7/13/2021 at 3:55 PM, the clinical manager indicated therapy should evaluate the patient within 5 days of assessment and OT had not yet evaluated the patient. During an interview on 7/13/2021 at 4:48 PM, the clinical manager indicated OT discharged the patient on 2/11/2021, but maybe the patient needed to be evaluated for additional OT services.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: 6. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Patient Medication Record." This document stated " ... Metoprolol [treats high blood pressure] Tartrate Oral 100 MG [milligrams] 1 Tab (s) [tablets] Daily BETA BLOCKER [reduced blood pressure] ... Norco Oral [opioid pain reducer] 5-325 MG 1 tab (s) Every 6 hours as needed for pain ANALGESICS-OPIOID [pain reducer] ... Midodrine HCl Oral 5 MG 1 tab (s) 3 times a day VASOPRESSORS [raises low blood pressure]...." These medications failed to be listed on the plan of care. During an interview on 7/14/21 at 4:36 PM, the clinical manager indicated the medications on the medication list are the most up to date and they did not get transferred to the plan of care. 7. Clinical record review on 7/14/21 for patient #4, start of care 5/30/21, evidenced an agency document titled "Plan of Care," signed by RN E dated 5/24/21, and signed by physician G, which had a subsection titled "Medications," which stated Lasix [treats fluid retention] Oral 40 MG 1 tab (s) every other day with 20 mg Tylenol Extra strength Oral 500 MG 1 tab (s) daily prn Pain Vitamin D [supplement] 500 MCG 1 Tab (s) po 2X daily Vitamin B12 [supplement] oral 50 MCG 1 tab (s) po daily ALPRaZolam [treats anxiety] Oral 2.5 MG 1 tab (s) po daily Bismuth Subsalicylate [treats upset stomach] Oral 262 1 Tab (s) po 2X daily Furosemide [treats water retention] Oral 20 MG 1 Tab (s) every other day alternating with 40 mg Gabapentin [treats nerve pain] Oral 300 mg 1 cap [capsule] po daily Docusate Sodium [stool softener] Oral 100 MG 1 Cap (s) po daily prn for constipation Levothyroxine Sodium [ treats thyroid disease] Oral 50 MCG 1 Tab (s) po daily Lisinopril [for high blood pressure] Oral 5 MG 1 Tab (s) po daily Magnesium Oxide [supplement] Oral 400 MG 1 Tab (s) po daily metFORMIN HCl [treats high blood sugar] Oral 500 MG 1 Tab (s) po daily Norco Oral 7.5-325 MG 1 tab (s) po 2x daily prn for pain Pantoprazole Sodium [for stomach acid] Oral 40 MG 1 Tab (s) po daily Slow Fe [iron supplement] Oral 143 (45 Fe) MG 1 tab (s) po Daily Trazadone [for sleep] HCl Oral 50 MG 1 Tab (s) po daily Tylenol Extra strength Oral 500 MG 1 tab (s) daily prn pain Vitamin D 500 MCG 1 Tab (s) po 2X daily Vitamin B12 oral 50 MCG 1 tab (s) po daily ALPRaZolam Oral 2.5 MG 1 tab (s) po daily AmLODIPine Besylate Oral 2.5 MG 1 Tab (s) po daily Bismuth Subsalicylate Oral 262 1 Tab (s) po 2X daily Furosemide Oral 20 MG 1 Tab (s) every other day alternating with 40 mg Gabepentin Oral 300 mg 1 cap [capsule] po daily Docusate Sodium Oral 100 MG 1 Cap (s) po daily prn for constipation Levothyroxine Sodium Oral 50 MCG 1 Tab (s) po daily Lisinopril Oral 5 MG 1 Tab (s) po daily Magnesium Oxide Oral 400 MG 1 Tab (s) po daily metFORMIN HCl Oral 500 MG 1 Tab (s) po daily Norco Oral 7.5-325 MG 1 tab (s) po 2x daily prn for pain Pantoprazole Sodium Oral 40 MG 1 Tab (s) po daily Slow Fe Oral 143 (45 Fe) MG 1 tab (s) po Daily Trazadone HCl Oral 50 MG 1 Tab (s) po daily...." This plan of care had duplicated medication and failed to be reviewed for accuracy. During an interview on 7/15/21 at 12:04 PM, patient #4 indicated she was no longer taking her 40 mg Lasix, she was just taking the 20 mg daily, she indicated she is no longer taking trazadone, she is taking Trajenta [for high blood sugar] 5 mg po daily, she is no longer taking her stool softener. She indicated she is taking Amlodipine 5 mg daily, and is only taking her iron on Monday, Wednesday, and Friday. During an interview on 7/15/21 at 3:26 PM, the alternate clinical manager indicated she was unsure why the medications were duplicated on the plan of care. She indicated she will look into the medications to make sure the proper medications and dosages are on the plan of care. 17-14-1(a)(1)(B) Based on observation, record review and interview, the home health agency failed to review all medications the patient was currently taking in order to identify any potential adverse effects and drug reactions in 5 of 8 complete clinical records reviewed. (#2, #3, #4, #6, #7) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Medication Profile" stated, "... Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications. ... Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen. 2. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed ... and with the addition of a new medication. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy and noncompliance with drug therapy...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide (HHA) services 1 time a week for 9 weeks. Review of an agency document titled "Patient Medication List", dated 2/10/2021, and digitally signed by RN M, indicated the patient's medication included, but was not limited to, Alprazolam (a medication used to treat anxiety), Tramadol (medication used to treat moderate to severe pain), Seroquel (a medication used to treat bipolar disorder and depression) and Carbidopa-Levodopa (a medication used to treat Parkinson's disease). Review failed to evidence the patient's medications had been reviewed for potential adverse effects and drug interaction since 2/10/2021. During an interview on 7/15/2021 at 12:30 PM, the alternate clinical manager indicated the last medication profile was dated 2/10/2021, and there was no documentation of a medication review since then. 3. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 6/27/2021, and digitally signed by RN L. This document stated, "... Physician notified of severe medication interactions? Yes ...." The document failed to indicate what were the medication interactions of which the physician was notified. During an interview on 7/13/2021 at 4:07 PM, the clinical manager stated, "I don't know what the interactions are; I don't know how to do that." During an observation of care at the patient's home on 7/13/2021 at 4:43 PM, the patient's medication were observed in his bedside table. A medication bottle labeled "Gabapentin [a medication used to treat seizures and nerve pain]" was observed in the drawer of the patient's bedside table and indicated the patient was to take 300 milligrams (mg) by mouth daily. Review failed to evidence Gabapentin was included on the medication profile and reviewed for potential adverse effects and drug reactions. During an interview on 7/13/2021 at 4:43 PM, the patient indicated he takes Gabapentin every day. During an interview on 7/15/2021 at 9:56 AM, the alternate clinical manager indicated Gabapentin should be included on the medication profile and reviewed by the nurse. 4. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 3/9/2021, and digitally signed by RN I. This document stated, "... Patient prescribed clindamycin [antibiotic] for gum infection, took approximately 6 doses with N/V [nausea and vomiting] and chest pain. Patient was seen in ER [emergency room] on 3/6/2021, with no changes in orders, clindamycin stopped and dentist calling in new prescription...." Review of an agency document titled "Patient Medication Profile", dated 2/26/2021, and digitally signed by RN I, failed to evidence clindamycin was included in the list of patient's medication and failed to evidence clindamycin was reviewed to include potential side effects and drug reactions. During an interview on 7/13/2021 at 4:36 PM, the clinical manager indicated clindamycin was not entered on to the medication profile and it would be there if it had been reviewed. 5. During an interview upon entrance on 7/12/2021 at 9:40 AM, the clinical manager indicated the skilled nurse reviews medication by entering all medication on to the medication profile where the electronic health record software reviews the medication for medication interactions and duplicative drug therapy and the medication profile is reviewed at start of care, every 60 days and when new medications are entered on to the medication profile.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment was updated and revised as frequently as the patient's condition warranted due to a major decline in the patient's health status in 1 of 2 closed clinical records reviewed. (#7) The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Initial and Comprehensive Assessment" stated, "... The assessment will be patient-specific and comprehensive to include the patient's need for home care ... The assessment will measure patient outcomes from data collected at the start of care and at the following defined intervals thereafter: ... Significant change in condition resulting in a new case mix ... During the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient's progress towards goals and other relevant information will be documented in the patient's clinical record, including at least the following information, if applicable: A. Outcomes and Assessment Information Set (OASIS) data must be collected on all patients receiving skilled services ... The OASIS data will be collected during the comprehensive assessment. B. A physical assessment, including temperature, pulse, respiration, skin, pain status, height/weight, nutritional status, and other relevant data related to pertinent physical findings...." Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 3/9/2021, and digitally signed by RN I. This document stated, "... Patient prescribed clindamycin [antibiotic] for gum infection, took approximately 6 doses with N/V [nausea and vomiting] and chest pain. Patient was seen in ER [emergency room] on 3/6/2021 with no changes in orders, clindamycin stopped and dentist calling in new prescription...." Review failed to evidence the skilled nurse assessed the patient's mouth to include the gums related to the gum infection. Review failed to evidence the skilled nurse completed the OASIS comprehensive assessment per agency policy related to the patient's change in condition for the new infection. During an interview on 7/13/2021 at 4:36 PM, the clinical manager indicated an infection is considered a significant change in condition and the skilled nurse should have assessed the patient's gums. The clinical manager had no response for why the OASIS reassessment was not performed for the significant change in condition related to the infection. 17-14-1(a)(1)(B)

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: 13. Clinical record review on 7/14/21 for patient #4, start of care 5/30/21, evidenced an agency document titled "Plan of Care," signed by RN E dated 5/24/21, and signed by physician G. Diagnoses included but not limited to Type 2 diabetes mellitus [high blood sugar] with diabetic chronic kidney [organ that filters waste from the body] disease, hypertensive [high blood pressure] chronic kidney disease chronic kidney disease stage 4, type 2 diabetes with diabetic peripheral angiopathy [disease of arteries, veins, and capillaries] without gangrene [death of tissue] Type 2 diabetes with diabetic neuropathy [numbness, loss of sensation], intervertebral disc displacement, lumbar [low back] region, asthma [breathing issues], hypothyroidism [low thyroid hormone], major depressive disorder, single episode, sleep apnea start and stop breathing during sleep], long term use of hypoglycemic [low blood sugar] drugs, history of falling. A subsection titled "Orders and Treatments" stated " ... SN [skilled nurse] to perform head to toe assessment including but not limited to the following: Mental Status, Nutrition/Hydration status Cardiovascular [having to do with the heart] Status, Respiratory [having to do with the lungs] Status, Safety, Medications, S/Sx of Infection, Pain and Vital Signs ... SN to instruct on all aspects of Diabetes management to include disease process, foot assessments, signs and symptoms of hypo/hyperglycemia, glucometer use and preparation and administration of diabetic medications ordered by physician SN to instruct patient on non pharmacological pan relief including relaxation techniques, massage, stretching, positioning, and/or hot/cold pack SN to assess for skin break down every visit SN to instruct patient on methods to reduce friction and sheer SN to instruct patient to float heels...." Clinical record review evidenced an agency document titled "OASIS -D1 Recertification" dated 3/30/21, and digitally signed by RN L. This document had a subsection titled "ADLs/IADLs [activities of daily living/instrumental activities of daily living]" which stated " ... Grooming: 1 Grooming utensils must be be placed with in reach before able to complete grooming activities Ability to dress upper body ... Able to dress upper body without assistance if clothing is laid out or handed to the patient ... Ability to dress lower body ... Able to dress lower body without assistance if clothing is laid out or handed to the patient ... Bathing ... able to participate in bathing self in the shower or tub, but requires the presence of another person throughout the bath for assistance or supervision...." Clinical Record review evidenced an agency document titled "Recert Case Conference" dated 3/31/21, and signed by RN I, which stated "Patient recertified to home health. She lives alone, uses a walker and cane for ambulation. She has Diabetes blood sugars run 130-170. She has pain to the low back 6/10, use Norco or Tylenol. Patient needs assistance getting in and out of the shower. can wash herself with standby assist. Requesting HCA [home care aide] 1x/week for safety with showering SN 1x/week HCA 1x/week...." Clinical Record review evidenced an agency document titled "Recert [recertification] Case Conference" dated 3/31/21, and signed by office coordinator which stated "Please get auth [authorization] for HCA for pt [patient] for new cert period ... Auth approved and added to auth screen...." Clinical record review of patient #4's electronic record failed to evidence patient #4 received home health care aide services. During a home visit interview on 7/15/21 at 12:25 PM, patient #4 indicated she was having a very difficult time getting in the shower. She indicated she was afraid she will fall. Patient #4 indicated she has been asking for someone to come out to help her with her bathing, and the agency stated they are trying to get someone for her. She indicated she has been waiting a long time, but the agency does not have anyone who can help. During an interview on 7/15/21 at 2:25 PM, the alternate clinical manager indicated patient #4 would benefit from home health aide services and the agency was trying to get an aide to assist patient #4 with her bathing. She indicated they do not currently have someone who can go to that area. But are actively looking to hire some home care assistants. 14. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21, and electronically signed by RN L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]..." This document had an area subtitled "Orders and Treatments" which stated " SN 2xwk/1wk; 4xwwk[sic]/4wks; 3xwk/4wks ... Wound care: Cleanse with betadine [destroys and/or prohibits bacteria] pack wounds with Iodoform [antiseptic dressing to destroy and prohibit bacteria growth] gauze and cover with DSD [dry sterile dressing] to be done every other day ...." Clinical record review evidenced untitled agency documents dated 6/17/21 and 6/19/21, and signed by RN M which stated, "Traveled to Patient: No reason: Doctor-Clinical Appointment...." Clinical record review of patient #3's electronic record failed to evidence the agency rescheduled these wound treatment visits. During an interview on 7/14/21 at 3:22 PM the clinical manager indicated they reschedule any missed visits when ever possible. She did not know why these visits were not rescheduled. 15. Clinical record review on 7/13/2021 for patient #5, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but was not limited to, Essential Primary Hypertension [high blood pressure] ... This document had an area subtitled "Orders and Treatments" which stated "SN 2w4 [twice a week for four weeks], 1w5 [once a week for five weeks] PT [physical therapy] 1w1 [once a week for one week] , OT [Occupational therapy 1w1...." Clinical record review for patient #5 evidenced an undated and unsigned agency document titled "Missed Visit" which stated " ... Discipline OT Date(s) of Missed Visit 6/10/2021 ... Pt [patient] stated he was in too much pain...." There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. Clinical record review for patient #5 evidenced an undated and unsigned agency document titled "Missed Visit" which stated " ... Discipline OT Date(s) of Missed Visit 6/17/2021 ... Pt stated he was in too much pain...." There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. Clinical record review for patient #5 evidenced an undated and unsigned agency document titled "Missed Visit" which stated " ... Discipline OT 6/29/2021 ... Date(s) of Missed Visit 6/22/21 & 6/24/21 ... Pt stated he was in too much pain ...." There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. Clinical record review for patient #5 evidenced an undated and unsigned agency document titled "Missed Visit" which stated " ... Discipline OT 6/29/2021 ... Date(s) of Missed Visit 6/29/21 & 7/1/21 ... Pt stated he is waiting to get a pain shot to continue therapy...." There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. Clinical record review of patient's #5's clinical record failed to evidence the agency met the needs of patient #5. Clinical record review evidenced he received occupational therapy only on 6/3/21, 6/8/21 and 6/15/21. Patient #5 did not receive therapy twice per week as ordered by the physician. Clinical record review for patient #5 evidenced agency document titled "Missed Visit Form- (PT Visit) signed by PT G and dated 6/8/21" which stated " ... pt's [patients's] wife canceled PT session for today d/t [due to] patient's c/o [complaint of] sever [sic] back pain. There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. Clinical record review for patient #5 evidenced agency document titled "Missed Visit Form- (PT Visit)" signed by PT G and dated 6/17/21 which stated " ... pt canceled PT session for today c/o [complaint of] sever [sic] fatigue and increased back pain...." There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. Clinical record review for patient #5 failed to evidence patient #5 failed to evidence patient #5 received physical therapy twice per week the weeks of 6/6/21 to 6/12/21 and 6/13/21 to 6/19/21 as ordered. Clinical record review for patient #5 evidenced tangency document titled "Missed Visit Form- (RN-Skilled Nursing Visit)" signed by RN-E and dated 6/10/21 which stated " ... Reason: No answer to phone call...." There failed to be evidence in the patient's electronic record evidencing this visit was rescheduled or attempted to be rescheduled. During an interview on 7/15/21 at 3:55 PM, the alternate clinical manager indicated she would look into why the visits were not rescheduled. 16. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type two diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had a subsection titles "Orders and Treatments," which stated "SN 2xwk/1wk [twice a week for one week; 1xwk/8wks [ once a week for eight weeks & 2 PRN [as needed] visits for catheter problems PT [physical therapy] 1x1wk [once a week for one week] to begin the week of 5/17/21 OT [occupational therapy] 1x1wk [once a week for one week] to begin the week of 5/17/21...." Clinical record review evidenced an agency document titled "OASIS -D1 Start of Care" dated 5/10/21, and digitally signed by RN L. This document had a subsection titled ADLs/IADLs [activities of daily living/instrumental activities of daily living] which stated " ... Grooming: 2 Someone must assist the patient to groom self Ability to dress upper body ... Someone must help the patient put on upper body clothing ... Ability to dress lower body ... Patient depends entirely upon another person to dress lower body ... Bathing ... able to participate in bathing self in the shower or tub, but requires the presence of another person throughout the bath for assistance or supervision ... Toilet Transferring ... Is totally dependent in toileting ... Toilet Hygiene ... Patient depends totally on another person to maintain toilet hygiene ... unable to transfer self and is unable to bear weight or pivot when transferred by another person chairfast unable to ambulate and unable to wheel self...." Clinical record review for patient #3 failed to evidence the agency met the needs of the patient, failed to offer home health services and failed to evidence the patient received physical and occupational therapy services. During an interview on 7/14/2021 at 9:52 AM, Person E (spouse of patient 3) indicated they are just waiting on the therapist to call and set up an appointment to begin services. She indicated she had not heard from them yet and let home health agency know that he needs his therapy. She indicated they were not offered a home health aide. During an interview on 7/14/2021 at 4:01 PM, the clinical manager indicated therapy was unable to reach the patient to schedule services Therapy made multiple calls, the calls were unanswered and the therapist was unable to leave a message. She indicated they do not have a home health aide to service that area and the family did not want to go to another agency. 17-13-1(a) Based on record review and interview, the home health agency failed to ensure: the plan of care was reviewed by the physician, individualized and followed by all agency staff (See tag G0572); the plan of care included all required information / elements for the treatment of the patient (See tag G0574); all patient care orders, including verbal orders, were recorded in the plan of care (See tag G0576); services and treatment were provided as ordered by a physician (See tag G0578); all treatments provided by agency staff were ordered by a physician (See tag G0580); the physician's verbal orders were documented in the patient's clinical record to include a signature, date and time of the order and failed to ensure the verbal orders were authenticated and dated by the physician (See tag G0584); the plan of care was reviewed by the patients primary care physician at least every 60 days (See tag G0588); physicians were promptly notified of a change in the patient's condition (See tag G0590); the plan of care was revised to reflect current health status and nursing needs (See tag G0592); coordination of care for all services provided to the patient (See tag G0606); the written visit schedule was provided to patients (See tag G0614); and written instructions were provided to the patient for the patient's medication schedule and instructions (See tag G0616). The cumulative effect of these systemic problems has resulted in the home health agency inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.60 Care Planning, Coordination of Care and Quality of Care. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the home health agency failed to ensure their patient's needs were being met in 7 of 8 complete clinical records reviewed (#1, #2, #3, #4, #5, #6, #7) and 2 of 2 partial clinical records (#9, #10) reviewed. The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Responsibilities/Supervision of Clinical Services" stated, "... If staffing is problematic, the Clinical Director, in coordination with the Clinical Supervisors, will review options, which include, but will not be limited to: 1. Use of outside, contracted organization personnel ... Use of office nursing personnel ... Any issue not resolved will be brought to the attention of the Executive Director/Administrator...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Care Planning Process" stated, "... Plan of Care: The patient-specific clinical plan of care includes: All patient care orders including verbal orders ... The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals...." 3. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Scope of Services" stated, "... Home care services are provided on an intermittent basis to patients in their place of residence. ... Professional nursing services are provided in accordance with the patient's plan of care .... and include ... Initiating appropriate preventative and rehabilitative nursing procedures ... Referral to other services as needed ... Home health aide duties include: A. Assisting with personal hygiene B. Assisting with ambulation and exercise ... Other supportive tasks as assigned ... Rehabilitative therapies are provided according to the patient's plan of care ... Speech/language pathology services are provided according to the patient's plan of care ... Social work services are provided according to the patient's plan of care... 4. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Ongoing Assessments" stated, "... During each home visit the appropriate clinician will re-evaluate the patient according to the problems identified during the initial visit and thereafter. ... Based on the findings of the reassessment, change/verbal orders will be generated and forwarded to the physician...." 5. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021 and digitally signed by registered nurse (RN) E. This document indicated the patient was incontinent (loss of control) of bowel and bladder, dependent for grooming, dressing, bathing and toileting and required assistance with ambulation and was at risk for falls. The document indicated the patient's discharge plan was to discharge to caregiver, person M, when goals were met. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide (HHA) services 1 time a week for 9 weeks. Review failed to evidence social work services were to be provided to the patient. Review of the agency's active patient roster indicated person M, the patient's spouse, was an active patient with the agency receiving skilled home care services. Review of an agency document titled "SNV [skilled nursing visit] w/ [with] Aide Supervision", dated 5/21/2021, and digitally signed by RN E, stated, "... patient has been stiffer and more rigid from his parkinson ...." This document indicated the patient had difficulty with ambulation, poor balance and joint pain and stiffness. Review failed to evidence the physician was notified of the change in stiffness and rigidity. Review evidenced the last skilled nursing visit was on 7/8/2021, and the last home health aide visit was on 6/3/2021. During an interview on 7/14/2021 at 2:24 PM, HHA H indicated she had not provided home health aide services to the patient for a few weeks because she was busy providing home health aide services for home health agency A and was just a fill-in home health aide for Advanced Home Health. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated she recently discovered the physician was not signing orders and there was no plan of care so the patient was placed on hold. The clinical manager indicated she had not yet communicated with the physician and had not received a hold order from the physician. During an interview on 7/14/2021 at 8:55 PM, RN E indicated the patient and his spouse lived alone and needed help. RN E stated, "They are not eating efficiently, maybe 1 meal a day." RN E indicated there is a family friend who grocery shops for them and transports them to medical appointments. RN E indicated she has encouraged the patient and his spouse to call Indiana 211, the Aging and Disability Resource Center. RN E stated, "The patient's wife is not appropriate to be the patient's emergency contact. She's in the same position as he is, both poor condition." RN E indicated the she sees the patient for falls, pain, weakness and the patient has increased tremors, balance issues and does not ambulate well. RN E indicated the patient was not completely safe in the home and had falls in the past. RN E indicated the patient could benefit from therapy services and when queried why a therapy referral had not been made, RN E explained she was unaware of the patient's payor status and what services were covered. During an interview on 7/15/2021 at 12:32 PM, licensed practical nurse (LPN) F indicated the patient had no caregiver other than his wife, person M, who was also a patient of the agency requiring skilled nursing care. LPN F indicated she sometimes delivered food to the patient if he had not eaten and purchased diabetic socks (socks with mild to moderate compression to alleviate discomfort and increase circulation) for the patient because he did not have any. During an interview on 7/15/2021 at 12:47 PM, when queried on who was providing personal care services for the patient when staff was not present, if the patient's spouse was also a patient and requiring assistance for personal care, the alternate clinical manager indicated when the patient needs more care or when there is a gap in care, the agency should make a referral for social work to evaluate the safety of the patient in the home. The alternate clinical manager indicated there was not any referral made for social work services for the patient. At 12:56 PM, the alternate clinical manager indicated a physical therapy (PT) referral should have been made to evaluate the patient to see if there was anything PT could do to help the patient. The alternate clinical manager indicated no PT referral was made. At 1:20 PM, the alternate clinical manager indicated she was unsure of who was assisting the patient while the agency was not providing home care services to the patient and there was no communication yet with the physician. 6. Clinical record review on 7/13/2021 for patient #6, start of care 12/29/2020, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021, and digitally signed by registered nurse (RN) L. This document indicated the patient's diagnoses included, but were not limited to, Stage III pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in full thickness skin loss) to the right heel, fracture to the right tibial tuberosity (a bone in the lower leg), chronic pain and a history of falls. The nurse assessed the patient to live alone, requiring assistance for dressing the lower body and bathing. The patient was assessed to be at risk for falls and requiring the use of a walker for ambulation and indicated occupational therapy (OT) 1 time a week for 1 week was needed for an OT evaluation. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021, indicated the patient was to receive OT services 1 time a week for 1 week. Review failed to evidence OT services had been provided as directed in the comprehensive assessment. During an interview on 7/13/2021 at 3:55 PM, the clinical manager indicated therapy should evaluate the patient within 5 days of assessment and OT had not yet evaluated the patient. 7. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, and a primary diagnosis of Alzheimer's Disease (a type of dementia that affects memory, thinking and behavior), evidenced an agency document titled "OASIS-D1 Recertification", dated 2/26/2021 and digitally signed by registered nurse (RN) I. This document indicated the nurse assessed the patient's diet requirements to be a heart healthy diet and easy to chew. The patient was not assessed to have any difficulty with swallowing. This document indicated the nurse assessed the patient to be dependent in bathing, dressing and toileting and requiring assistance for grooming. This document stated, "... OT [occupational therapy] to re-eval [re-evaluate]. HCA [home care aide] to continue to assist with ADLs [activities of daily living] and evidenced the frequency of the services to be provided to the patient included OT for 1 visit for evaluation and home health aide for 2 times a week for 8 weeks and then 1 time a week for 1 week beginning on 2/28/2021. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, and signed by RN I and the physician. This document indicated the physician orders included the patient to be seen for an OT evaluation and for home health aide services 2 times a week for 8 weeks and then 1 times a week for 1 week beginning 2/28/2021. This document indicated the nutritional orders were for a heart healthy, easy to chew diet. Review failed to evidence home health aide services were provided after 3/31/2021, and failed to evidence OT therapy services for an evaluation were provided. During an interview on 7/13/2021 at 4:30 PM, the clinical manager indicated the last home health aide visit was on 3/31/2021, because the home health aide "fell off the face of the Earth." At 4:48 PM, the clinical manager indicated OT discharged the patient on 2/11/2021, but maybe the patient needed to be evaluated for additional OT services. Review of an agency document titled "RN-Skilled Nursing Visit", dated 3/16/2021, and digitally signed by RN I, indicated the patient had been hospitalized from 3/11/2021 to 3/14/2021, for a large hernia. This document stated, "... Educated on using thickened liquids as daughter states patient 'spits up' after meals...." Review failed to evidence the physician was contacted regarding the caregiver's report the patient was spitting up after meals or requiring thickened liquids. Review failed to evidence the agency obtained an order and made a referral to speech therapy to evaluate the patient spitting up during meals and requiring thickened liquids. During an interview on 7/13/2021 at 4:43 PM, the clinical manager stated, "I don't see the physician was notified and or a speech therapy referral was made. Speech therapy should eval." 8. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021, and digitally signed by RN L, which indicated the patient's diagnoses were Parkinson's disease and hypertension (high blood pressure). Review evidenced the patient lived alone, ate mostly frozen meals and a referral was needed to a medical social worker (MSW) for housing choices. Review indicated the patient was at risk for falls and had difficulty with ambulation, limited mobility and poor balance. The document stated, "... has frequent falls. She lives in 1 room of a house ... has to climb 4 stairs to garage to access the refrigerator and microwave...." Review indicated the agency services were to include skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/15/2021 - 8/13/2021, signed and dated by the nurse practitioner on 7/15/2021, indicated the orders for services included skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review failed to evidence the patient had received any skilled nursing, PT, OT and MSW services and failed to evidence any communication regarding skilled nursing services, OT and MSW services. During an interview on 7/15/2021 at 2:22 PM, the alternate clinical manager indicated the agency was unable to reach the patient and staff should contact the clinical manager when unable to contact the patient "so it's on our radar." The alternate clinical manager indicated sometimes the agency will call the local authorities to conduct a well visit when unable to reach a patient but it was not agency policy that it had to be done. During an interview on 7/15/2021 at 2:24 PM, office coordinator D indicated she just received an email from therapy company C regarding communication with the patient and a scheduled PT evaluation. Office coordinator indicated she had just entered the information into the clinical record regarding the message from therapy agency C. Review of an agency document titled "Patient Notes/Messages", dated 7/15/2021, and entered by office coordinator D, indicated there was a therapy services update and noted a document attachment. Review of an agency document titled "Narrative Note", dated 7/7/2021, and electronically signed by PT P, which indicated therapy company C had difficulty reaching the patient to schedule initial PT evaluation, but was now scheduled for 7/15/2021. Review failed to evidence any communication regarding PT services until communication with therapy agency C on 7/15/2021. During an interview on 7/15/2021 at 2:24 PM, when queried why therapy agency C had made patient contact but the agency had not, the alternate clinical manager indicated a missed visit note in the clinical record on 6/30/2021, indicated the nurse attempted to call the patient but there was no answer. The alternate clinical manager indicated there was no communication from the agency regarding attempts to contact the patient since 6/30/2021. At 2:35 PM, the alternate clinical manager indicated office coordinator D usually sent the referrals for MSW services and indicated there was no communication regarding MSW services for the patient. The alternate clinical manager asked office coordinator D if a MSW referral was sent to agency D, office coordinator D stated, "No one has told me to contact [agency D] for a MSW referral." 9. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021, and digitally signed by RN L. This document indicated the patient's diagnoses included, but were not limited to: neck muscle strain, right lower leg contusion (bruise), Parkinson's disease, spinal stenosis (narrowing of the spaces within the spine putting pressure on the nerves) and diabetes (a chronic disease affecting how the body uses blood sugar). Review indicated the patient was at risk for falls, had difficulty with ambulation requiring the use of a cane and had poor balance. This document indicated the patient required assistance with dressing the lower body and bathing and stated, "... [patient] has not been taking a shower last few months, gait to [sic] unsteady and no one to assist him ... Has several stairs leading outside, he fell yesterday down these stairs; needs assistive device and assist to leave home ...." Review indicated the patient was to receive home health aide services 1 time a week for 9 weeks. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 4/15/2021 - 6/13/2021, signed and dated by the physician on 4/21/2021, indicated the orders for agency services included home health aide services 1 time a week for 9 weeks. Review failed to evidence the patient had received any home health aide services and failed to evidence communication regarding the home health aide services. During an interview on 7/15/2021 at 5:05 PM, the alternate clinical manager indicated there was no record of home health aide services provided to the patient and no communication in the record why home health aide services were not provided. 10. During an interview on 7/13/2021 at 10:15 AM, the clinical manager indicated the agency went awhile without a home health aide to provide home health aide services until HHA H came from home care agency A to help out. 11. During an interview on 7/15/2021 at 10:10 AM, the alternate clinical manager indicated the agency has discharged patients due to not being able to provide home health aide services and should not accept patients needing home health aide services. The alternate clinical manager indicated the agency had advertised for home health aides and conducted interviews but had not yet found the right fit. The clinical manager indicated the agency had not offered a sign-on bonus for home health aides and the agency had not contracted home health aide services from another agency. 12. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he was unaware of any services not provided.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: 9. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type 2 diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had an area subtitled "Orders and Treatments" which stated "SN [skilled nursing] 2xwk/ 1wk[twice a week for one week]; 1xwk/8wks [once a week for eight weeks] & 2 PRN [as needed] for catheter problems, PT [physical therapy] 1x/1wk [once a week for one week] to begin week of 5/17/21 OT [occupational therapy] 1x1wk to begin week 5/17/21 ... OT Evaluation and treatment. OT plan and treatment will be developed in collaboration with the physician after the evaluation visit is completed ... PT Evaluation and treatment. PT plan and treatment will be developed in collaboration with the physician after the evaluation visit is completed ... Notify physician of Temperature greater than (>) 101.5 or less than () 120 or less than () 30 or less than ()160 or less than) 90 or less than (<) 58 O2 Sat [saturation] less than (<) 90...." This document failed to evidence the plan of care was established by the physician and the parameters were specific to the patients diagnoses. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated the physician has not returned the signed plan of care. She indicated the patient should be on a renal diet with fluid restriction, and there should be parameters for weights and blood sugar. 10. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21, and electronically signed by RN L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]...." This document had an area subtitled "Orders and Treatments," which stated, " SN 2xwk/1wk [twice a week for one week]; 4xwwk[sic]/4wks [four times a week for four weeks]; 3xwk/4wks [three times a week for four weeks] ... SN to instruct the patient on appropriate nail care as follows: trim nails straight across and file rough edges with nail file SN to instruct the patient to inspect patient's feet daily and report any skin or nail problems to the SN SN to instruct patient to moisturize daily but to avoid getting in between toes SN to instruct the patient should never walk barefoot SN to perform inspection of lower extremities every visit and report any alteration to the the physician...." Clinical record review evidenced agency documents titled RN Skilled Nursing Visit" dated 6/15/21 and 7/5/21, signed by RN M. These documents failed to evidence patient #1 was instructed to inspect and report any problems with his feet to the skilled nurse, how to trim his nails, moisturize his feet daily, never to walk barefoot. These documents also failed to evidence the skilled nurse did an assessment of the patients lower extremities. Clinical record review evidenced an agency document titled "RN Skilled Nursing Visit" dated 6/23/21, and signed by RN B. This document failed to evidence patient #1 was instructed to inspect and report any problems with his feet to the skilled nurse, how to trim his nails, moisturize his feet daily, never to walk barefoot. These documents also failed to evidence the skilled nurse did an assessment of the patients lower extremities. Clinical record review evidenced untitled agency documents dated 6/17/21, 6/19/21, and signed by RN M which stated, "Traveled to Patient: No Reason: Doctor-Clinical Appointment...." Clinical record review of patient #1's electronic record failed to evidence the agency rescheduled these wound treatment visits. She indicated the care plan should be followed but sometimes they cannot do everything on every visit. The clinical manager indicated the agency will reschedule missed visits and was unsure why the visits were not rescheduled. 11. Clinical record review on 7/14/2021 for patient #5, start of care 5/30/20 and a primary diagnosis of Type 2 diabetes [high blood sugar] with chronic kidney disease [disease affecting ability to filter waste], evidenced an agency document titled "OASIS-D1 Recertification", dated 3/31/2021 and digitally signed by RN [registered nurse] E. This document indicated the patient was incontinent [loss of control] of bowel and bladder, difficulty with ambulation, shortness of breath, needs assistance with dressing and was at risk for falls. This document indicated the patient's goals included, but were not limited to, skin to remain intact, will understand proper use of pain medication, maintain no concentrated sweets and heart healthy diet and will be free of signs and symptoms of hypo(low blood sugar)/hyperglycemia (high blood sugar). This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide services 1 time a week for 9 weeks. Review of agency documents titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 3/20/2021, 4/6/2021, 4/15/2021, 4/20/2021 and 4/27/2021 by RN M. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Review failed to evidence a plan of care was established by the physician for the patient for certification period 3/30/2021 - 5/24/2021, to include the patient's diagnoses, medication, services to be provided, treatments and goals. 17-13-1(a)(1)(B) Based on observation, record review and interview, the agency failed to ensure the patients received the services as directed in the plan of care, the plan of care was individualized and established by the primary care physician in 6 of 8 complete clinical records (#1, #2, #3, #5, #6, #7) reviewed and 2 of 2 partial clinical records (#9, #10) reviewed. The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Scope of Services" stated, "... Professional nursing services are provided in accordance with the patient's plan of care ... Rehabilitative therapies are provided according to the patient's plan of care ... Social work services are provided according to the patient's plan of care...." 2. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. ... Individualized Plan of Care: The patient-specific clinical plan of care includes: All patient care orders including verbal orders...." 3. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient was incontinent (loss of control) of bowel and bladder, dependent for grooming, dressing, bathing, toileting and required assistance with ambulation and was at risk for falls. This document indicated the patient's goals included, but were not limited to, skin to remain intact, achieve a pain level less than 4 out of 10 and maintain ADL (activities of daily living) status. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide (HHA) services 1 time a week for 9 weeks. Review of agency documents titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 4/21/2021 and 4/28/2021 by RN M, on 5/12/2021, 5/21/2021, 6/2/2021 and 7/1/2021 by RN E and on 5/27/2021, 6/17/2021, 6/24/2021, 6/29/2021 and 7/8/2021 by licensed practical nurse (LPN) F. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Review of agency documents titled "HHA Visit", digitally signed by HHA H, indicated the patient received HHA services to include personal care and ADL assistance on 4/15/2021, 4/22/2021, 4/29/2021, 5/6/2021, 5/13/2021, 5/20/2021, 5/27/2021 and 6/3/2021. Review of an agency document titled "Patient Medication List", dated 2/10/2021, and digitally signed by RN M, indicated the patient's medication included, but was not limited to, Alprazolam (a medication used to treat anxiety), Tramadol (medication used to treat moderate to severe pain), Seroquel (a medication used to treat bipolar disorder and depression) and Carbidopa-Levodopa (a medication used to treat Parkinson's disease). Review failed to evidence a plan of care was established for the patient since the certification period of 2/14/2021 - 4/14/2021, to include the patient's diagnoses, medication, services to be provided, treatments and goals. During an interview on 7/14/2021 at 3:53 PM, office coordinator D indicated she had called the office of physician L regarding the unsigned physician orders and the physician's office informed office coordinator D there was no record of the patient at the physician's office. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated RN M had been the patient's nurse case manager but had passed away. When queried when was the last plan of care, the clinical manager indicated there was not a plan of care since the certification period of 2/14/2021 - 4/14/2021 and stated, "I discovered it the other day so that's why patient is listed 'on hold'." 4. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021. This document indicated the patient's diagnoses included, but were not limited to, Stage III pressure ulcer (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in full thickness skin loss) to the right heel, fracture to the right tibial tuberosity (a bone in the lower leg) and chronic pain. This plan of care indicated the skilled nurse was to notify the physician for foul odor and other significant changes. This document indicated the patient was to receive physical therapy (PT) and occupational therapy services 1 time a week for 1 week for an evaluation and the document stated, "... Measures to address risk for ER [emergency room]/Hospitalization: ... Pain control ...." Review failed to evidence OT services had been provided as directed in the plan of care. During an interview on 7/13/2021 at 3:55 PM, the clinical manager indicated therapy should evaluate the patient within 5 days of assessment and OT had not yet evaluated the patient. Review of an agency document titled "PT Visit", digitally signed by PT G and dated 7/1/2021, indicated the PT assessed the patient to have pain to the right knee, but failed to assess the patient's level of pain before and after therapy for pain control as directed in the plan of care. During an observation of care at the patient's home on 7/14/2021 at 4:18 PM, the patient was observed with a dressing wrapped around the right foot. PT G was observed assisting patient with lower body exercises, assisting patient to ambulate using the walker and assisting the patient to climb up and down stairs. PT G was not observed to have assessed the patient's pain prior to conducting PT services. During an interview on 7/13/2021 at 3:58 PM, the clinical manager indicated therapists should assess for pain before therapy treatment. Review evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021 and digitally signed by registered nurse (RN) L. This document indicated the patient had a Stage III pressure wound (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in full thickness skin loss) to the right heel measuring 4.5 centimeters (cm) in length, 5.7 cm in width and 0.5 cm in depth with moderate serous (clear to slightly yellow in color) drainage and with an odor present. Review of agency documents titled "RN - Skilled Nursing Visit", dated 7/5/2021 and 7/7/2021 and digitally signed by RN L, indicated the patient's pressure wound to the right heel had foul odor. The document failed to evidence the physician was contacted as directed in the plan of care. Document dated 7/10/2021, and digitally signed by the clinical manager indicated the pressure wound to the right heel was 4.0 cm in length, 6.5 cm in width, 0.5 cm in depth with greenish drainage and a foul odor. The document indicated the physician was contacted regarding wound drainage and the patient was to make an appointment with the physician. During an interview on 7/13/2021 at 9:03 AM, nurse H at the office of physician I, indicated there was no communication in the physician's office record regarding the patient's wound and no communication with the home care agency. Nurse H indicated the physician's office was not open on 7/10/2021, and there was no message left regarding the patient's wound from the home care agency. During an interview on 7/13/2021 at 10:45 AM, the clinical manager indicated she believed the patient would end up needing intravenous antibiotics (medication used to treat infection and administered through a needle inserted into the patient's bloodstream) because the wound was not healing. The clinical manager indicated the patient may end up needing to go to a wound clinic. At 3:37 PM, the clinical manager indicated she did not call to inform the physician on 7/10/2021, regarding the wound but rather on 7/12/2021. When queried why the physician communication was documented as completed on 7/10/2021, the clinical manager indicated it was a documentation error. When queried what wound information was communicated to the physician on 7/12/2021, and where it was documented, the clinical manager indicated she could not recall if the physician was contacted regarding the patient's wound. 5. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, and signed by registered nurse I and the physician. This document indicated the patient was to receive home health aide services 2 times a week for 8 weeks and then 1 time a week for 1 week beginning the week of 2/28/2021. Review indicated the patient received home health aide services 3 times during week 4 beginning 3/21/2021, and 1 time during week 5 on 3/31/2021. Review failed to evidence home health aide services were provided after 3/31/2021, and failed to evidence home health aide services were provided as directed in the plan of care. This document indicated the physician orders included the patient to be seen for an OT (occupational therapy) evaluation, but review failed to evidence OT therapy services for an evaluation were provided as directed in the plan of care. During an interview on 7/13/2021 at 4:30 PM, the clinical manager indicated the last home health aide visit was on 3/31/2021, because the home health aide "fell off the face of the Earth." At 4:48 PM, the clinical manager indicated OT discharged the patient on 2/11/2021, but maybe the patient needed to be evaluated for additional OT services. 6. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021, and digitally signed by RN L, which indicated the patient's diagnoses were Parkinson's disease and hypertension (high blood pressure). Review evidenced the patient lived alone, ate mostly frozen meals and a referral was needed to a medical social worker (MSW) for housing choices. Review indicated the patient was at risk for falls and had difficulty with ambulation, limited mobility and poor balance. The document stated, "... has frequent falls. She lives in 1 room of a house ... has to climb 4 stairs to garage to access the refrigerator and microwave...." Review indicated the agency services were to include skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/15/2021 - 8/13/2021, signed and dated by the nurse practitioner on 7/15/2021, indicated the orders for services included skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review failed to evidence the patient had received any skilled nursing, PT, OT and MSW services as ordered on the plan of care. During an interview on 7/15/2021 at 2:22 PM, the alternate clinical manager indicated the agency was unable to reach the patient and staff should contact the clinical manager when unable to contact the patient "so it's on our radar." The alternate clinical manager indicated sometimes the agency will call the local authorities to conduct a well visit when unable to reach a patient, but it was not agency policy that it had to be done. During an interview on 7/15/2021 at 2:24 PM, office coordinator D indicated she just received an email from therapy company C regarding communication with the patient and a scheduled PT evaluation. Office coordinator indicated she had just entered the information into the clinical record regarding the message from therapy agency C. Review of an agency document titled "Patient Notes/Messages", dated 7/15/2021, and entered by office coordinator D, indicated there was a therapy services update and noted a document attachment. Review of an agency document titled "Narrative Note", dated 7/7/2021 and electronically signed by PT P, which indicated therapy company C had difficulty reaching the patient to schedule initial PT evaluation but was now scheduled for 7/15/2021. Review failed to evidence any communication regarding PT services until communication with therapy agency C on 7/15/2021. During an interview on 7/15/2021 at 2:24 PM, when queried why therapy agency C had made patient contact but the agency had not, the alternate clinical manager indicated a missed visit note in the clinical record on 6/30/2021, indicated the nurse attempted to call the patient, but there was no answer. The alternate clinical manager indicated there was no communication from the agency regarding attempts to contact the patient since 6/30/2021. At 2:35 PM, the alternate clinical manager indicated office coordinator D usually sent the referrals for MSW services and indicated there was no communication regarding MSW services for the patient. The alternate clinical manager asked office coordinator D if a MSW referral was sent to agency D, office coordinator D stated, "No one has told me to contact [agency D] for a MSW referral." 7. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021 and digitally signed by RN L. This document indicated the patient's diagnoses included, but were not limited to: neck muscle strain, right lower leg contusion (bruise), Parkinson's disease, spinal stenosis (narrowing of the spaces within the spine putting pressure on the nerves) and diabetes (a chronic disease affecting how the body uses blood sugar). Review indicated the patient was at risk for falls, had difficulty with ambulation requiring the use of a cane and had poor balance. This document indicated the patient required assistance with dressing the lower body and bathing and stated, "... [patient] has not been taking a shower last few months, gait to [sic] unsteady and no one to assist him ... Has several stairs leading outside, he fell yesterday down these stairs; needs assistive device and assist to leave home ...." Review indicated the patient was to receive home health aide services 1 time a week for 9 weeks. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 4/15/2021 - 6/13/2021, signed and dated by the physician on 4/21/2021, indicated the orders for agency services included home health aide services 1 time a week for 9 weeks. Review failed to evidence the patient had received any home health aide services as ordered in the plan of care. During an interview on 7/15/2021 at 5:05 PM, the alternate clinical manager indicated there was no record of home health aide services provided to the patient and no communication in the record why home health aide services were not provided. 8. During an interview on 7/13/2021 at 3:17 PM, the alternate clinical manager indicated the patient's plan of care was the 485. The alternate clinical manager indicated the therapy evaluation was not the patient's plan of care.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: 4. Clinical record review on 7/14/21 for patient #4, start of care 5/30/21, evidenced an agency document titled "Plan of Care," signed by RN E dated 5/24/21, and signed by physician G, which had a subsection titled "Medications," which stated Lasix [treats fluid retention] Oral 40 MG 1 tab (s) every other day with 20 mg Tylenol Extra strength Oral 500 MG 1 tab (s) daily prn Pain Vitamin D [supplement] 500 MCG 1 Tab (s) po 2X daily Vitamin B12 [supplement] oral 50 MCG 1 tab (s) po daily ALPRaZolam [treats anxiety] Oral 2.5 MG 1 tab (s) po daily Bismuth Subsalicylate [treats upset stomach] Oral 262 1 Tab (s) po 2X daily Furosemide [treats water retention] Oral 20 MG 1 Tab (s) every other day alternating with mg Gabepentin [treats nerve pain] Oral 300 mg 1 cap [capsule] po daily Docusate Sodium [stool softener] Oral 100 MG 1 Cap (s) po daily prn for constipation Levothyroxine Sodium [ treats thyroid disease] Oral 50 MCG 1 Tab (s) po daily Lisinopril [for high blood pressure] Oral 5 MG 1 Tab (s) po daily Magnesium Oxide [supplement] Oral 400 MG 1 Tab (s) po daily metFORMIN HCl [treats high blood sugar] Oral 500 MG 1 Tab (s) po daily Norco Oral 7.5-325 MG 1 tab (s) po 2x daily prn for pain Pantoprazole Sodium [for stomach acid] Oral 40 MG 1 Tab (s) po daily Slow Fe [iron supplement] Oral 143 (45 Fe) MG 1 tab (s) po Daily Trazadone [for sleep] HCl Oral 50 MG 1 Tab (s) po daily Tylenol Extra strength Oral 500 MG 1 tab (s) daily prn pain Vitamin D 500 MCG 1 Tab (s) po 2X daily Vitamin B12 oral 50 MCG 1 tab (s) po daily ALPRaZolam Oral 2.5 MG 1 tab (s) po daily AmLODIPine Besylate Oral 2.5 MG 1 Tab (s) po daily Bismuth Subsalicylate Oral 262 1 Tab (s) po 2X daily Furosemide Oral 20 MG 1 Tab (s) every other day alternating with mg Gabepentin Oral 300 mg 1 cap [capsule] po daily Docusate Sodium Oral 100 MG 1 Cap (s) po daily prn for constipation Levothyroxine Sodium Oral 50 MCG 1 Tab (s) po daily Lisinopril Oral 5 MG 1 Tab (s) po daily Magnesium Oxide Oral 400 MG 1 Tab (s) po daily metFORMIN HCl Oral 500 MG 1 Tab (s) po daily Norco Oral 7.5-325 MG 1 tab (s) po 2x daily prn for pain Pantoprazole Sodium Oral 40 MG 1 Tab (s) po daily Slow De Oral 143 (45 Fe) MG i tab (s) po Daily Trazadone HCl Oral 50 MG 1 Tab (s) po daily...." this plan of care failed to evidence the correct medications. During an interview on 7/15/21 at 12:16 PM, patient #4 indicated she had a medication list she wrote and follows. She indicated her medications were changed a few months ago. She takes Januvia [for blood sugar] she was taking only 20 mg of lasix daily. She indicated her Amlodipine she takes 5 mg daily, and her iron supplement she was taking only one Monday Wednesday and Friday. During an interview on 7/15/21 at 3:54 PM, the alternate clinical manager indicated she would make sure the medications were corrected on the plan of care. 17-13-1(a)(1)(D)(ix, xiii) Based on observation, record review and interview, the agency failed to ensure the individualized plan of care included all medications, treatments and measurable goals and outcomes in 3 of 8 complete clinical records reviewed. (#4, #6, #8) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... Individualized Plan of Care: The patient-specific clinical plan of care includes: Measurable outcomes and goals identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care ... Medications and treatments...." 2. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced a document from skilled nursing facility J, dated 6/21/2021, and electronically signed by nurse practitioner K, which indicated the patient's medication included, but was not limited to, Gabapentin (a medication used to treat seizures and nerve pain). During an observation of care at the patient's home on 7/13/2021 at 4:43 PM, the patient's medication was observed in his bedside table. A medication bottle labeled "Gabapentin" was observed in the drawer of his bedside table and indicated the patient was to take 300 milligrams (mg) by mouth daily. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021, failed to evidence the plan of care included Gabapentin in the list of the patient's medication. During an interview on 7/13/2021 at 4:43 PM, the patient indicated he takes Gabapentin every day. During an interview on 7/15/2021 at 9:56 AM, the alternate clinical manager indicated Gabapentin should be included in the plan of care. 3. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, and a primary diagnosis of Alzheimer's Disease (a type of dementia that affects memory, thinking and behavior), evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/12/2021 and digitally signed by registered nurse (RN) E. This document indicated the patient was incontinent (loss of control) of bladder, had difficulty with ambulation, had poor balance, was dependent for grooming, dressing, bathing and toileting and was at risk for falls. Review evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 4/12/2021 - 6/10/2021, dated 4/12/2021, and digitally signed by RN E, which indicated the patient was to receive physical therapy (PT) services 1 time a week for 1 week for evaluation and skilled nursing services 1 time a week for 9 weeks. The plan of care failed to evidence goals related to the skilled nursing and PT services the patient was to receive. During an interview on 7/13/2021 at 3:28 PM, the clinical manager indicated there were no patient-specific goals on the plan of care, but there should be.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: 3. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an untitled agency document dated 6//27/21, and electronically signed by RN L. This document was a verbal order which stated " Wound Vac to be used starting on 6/25/21, patient will use wet-dry dressing when VAC not being used. SN [skilled nurse] 1w1[once a week for one week]; 3w1 [three times a week for one week] ; 2w1 [twice per week for one week] and 2 PRN [as needed] visits for VAC problem...." This document failed to be authenticated and dated by the physician. Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "HOME HEALTH CERTIFICATION AND PLAN OF CARE" for certification period 6/9/21 to 8/7/21. This plan of care failed to evidence the verbal order for the patient #1's wound vac." During an interview on 7/14/21 at 3:57 PM, the clinical manager indicated there should have been an addendum to the plan of care. She was not able to locate the addendum in patient #1's clinical record. Based on record review and interview, the agency failed to record all patient care orders, including verbal orders, in the plan of care in 2 of 8 complete clinical records reviewed. (#1, #7) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Care Planning Process" stated, "... The plan of care will be based upon the physician's (or other authorized licensed independent practitioner's) orders and will encompass the equipment, supplies, and services required to meet the patient's needs. ... The plan of care will be revised as frequently as deemed necessary by the clinicians based on the ongoing assessments of the patient. ... Changes in the plan of care will be noted with the following documentation: ... Verbal orders ... Changes must be written, dated and signed by the professional making the changes...." 2. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Physician Order", dated 2/27/2021, and signed by registered nurse I and the physician. This document indicated the patient was to have the following tests performed weekly: CBC (complete blood count; a group of tests run from a blood sample that evaluate the cells that circulate in the blood), CMP (comprehensive metabolic panel; a test run from a sample of blood used to determine 14 different measurements which evaluate liver function, kidney function and nutrient levels), Magnesium (a blood test used to determine the amount of magnesium in the blood), Phosphorous (a blood test used to determine the amount of phosphorous in the blood) and a urine analysis (a lab test used to detect and substances in the urine). Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, and signed by registered nurse I and the physician indicated the patient was to have a BMP (basic metabolic panel; a group of tests run from a sample of blood to determine 8 different measurements), Magnesium, Phosphorous and urine analysis weekly, but failed to evidence the verbal order for a CBC and CMP to be obtained weekly was not recorded in the plan of care.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to provide services and treatment as ordered by a physician in 1 of 2 closed clinical records reviewed. (#7) The findings include: Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Physician Participation in Plan of Care" stated, "... The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice...." Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Physician Order", dated 2/27/2021, and signed by registered nurse I and the physician. This document indicated the patient was to have the following tests performed weekly: CBC (complete blood count; a group of tests run from a blood sample that evaluate the cells that circulate in the blood), CMP (comprehensive metabolic panel; a test run from a sample of blood used to obtain 14 different measurements which evaluate liver function, kidney function and nutrient levels), Magnesium (a blood test used to determine the amount of magnesium in the blood), Phosphorous (a blood test used to determine the amount of phosphorous in the blood) and a urine analysis (a lab test used to detect and substances in the urine). Review failed to evidence the agency conformed with the physician's order and obtained blood and urine tests for the weeks of 3/7/2021 and 3/28/2021. During an interview on 7/13/2021 at 4:16 PM, the clinical manager stated, "I don't see them either" when queried if the agency obtained the blood and urine tests as ordered by the physician during the weeks of 3/7/2021 and 3/28/2021.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to provide services and treatments only as ordered by a physician in 6 of 8 complete clinical records reviewed. (#1, #2, #3, #4, #5, #6) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Physician Participation in Plan of Care" stated, "... The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Admission Criteria and Process" stated, "... The patient's physician (or other authorized licensed independent practitioner) must order and approve the provision of any service. ... If the patient's physician does not make the request for service, he/she will be contacted for start of care orders prior to the evaluation visit and initiation of services...." 3. Review of an agency policy, revised November 2017, and obtained 7/15/2021, titled "Referral Disclosure and Care Decisions" stated, "... The referrals will be monitored, reviewed, and reported each month by the Program Director. ... The organization will accept only those patients ... who meet admission criteria. ... In compliance with standard medical practice, all services will be delivered under physician's (or other authorized licensed independent practitioner's) orders...." 4. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 4/21/2021 and 4/28/2021 by RN M, on 5/12/2021, 5/21/2021, 6/2/2021 and 7/1/2021 by RN E and on 5/27/2021, 6/17/2021, 6/24/2021, 6/29/2021 and 7/8/2021 by licensed practical nurse (LPN) F. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Review of agency documents titled "HHA Visit", digitally signed by HHA H, indicated the patient received HHA services to include personal care and ADL assistance on 4/15/2021, 4/22/2021, 4/29/2021, 5/6/2021, 5/13/2021, 5/20/2021, 5/27/2021 and 6/3/2021. Review failed to evidence signed physician orders since the plan of care for certification period of 12/16/2020 - 2/13/2021, which was signed by the physician on 12/30/2020. During an interview on 7/14/2021 at 3:53 PM, office coordinator D indicated she had called the office of physician L regarding the unsigned physician orders and the physician's office informed office coordinator D there was no record of the patient at the physician's office. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated RN M had been the patient's nurse case manager but had passed away. When queried when was the last plan of care, the clinical manager indicated there was not a plan of care since the certification period of 2/14/2021 - 4/14/2021 and stated, "I discovered it the other day so that's why patient is listed on hold." 5. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced a document from skilled nursing facility J, dated 6/21/2021 and electronically signed by nurse practitioner K, which indicated home health was to evaluate and treat for medications, vital signs, strength buildings, gait and activities of daily living. This document failed to evidence wound care orders. Review evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021 and digitally signed by (registered nurse) RN L. This document evidenced the nurse completed a comprehensive head-to-toe assessment, obtained vital signs, and provided wound care to the patient's Stage III pressure wound (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in full thickness skin loss) to the right heel. This document stated, "... Wound care to the R [right] heel: cleanse with saline [a salt water mixture used to clean wounds], apply silver alginate patch [an absorbent dressing for at risk or infected wounds] and cover with DSD [dry sterile dressing] ...." and failed to evidence wound care orders for the right heel. During an interview on 7/13/2021 at 3:49 PM, the clinical manager indicated she did not see wound care orders for the wound care provided by RN L at the initial comprehensive assessment. 6. Clinical record review on 7/13/2021 for patient #5, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but was not limited to, Essential Primary Hypertension [high blood pressure] ... This document had an area subtitled "Orders and Treatments" which stated "SN [skilled nurse] 2w4 [twice a week for four weeks], 1w5 [once a week for five weeks] PT [physical therapy] 1w1[once a week for one week], OT [Occupational therapy 1w1" This plan of care failed to be signed by the physician. Review of patient #5 electronic medical record evidenced skilled nursing visits were completed on 5/13/21, 5/18/21, 5/24/21, 5/27/21, 5/31/21, 6/3/21, 6/17/21, 6/22/21, and 7/1/21. Review of patient #5's electronic record evidenced an agency document titled "PT Evaluation," which had a subsection titled "Frequency and Duration", which stated "Frequency 1w1[one time a week for one week], 2w4 [two times a week for two weeks]. This evaluation failed to be signed by the physician. Review of patient #5 electronic medical record evidenced physical therapy visits were completed on 5/25/21, 6/1/21, 6/3/21, 6/10/21, 6/15/216/22/21, 6/24/21, 6/29/21, and 7/1/21 Review of patient #5's electronic medical record evidenced an agency document titled "Occupational Therapy Evaluation," which had a subsection titled "Frequency and Duration", which stated "Frequency and Duration 1w1[one time a week for one week], 2w8 [two times a week for eight weeks]. This evaluation failed to be signed by the physician. Review of patient #5 electronic medical record evidenced physical therapy visits were completed on 5/17/21, 5/27/21, 6/3/21, 6/8/21, 6/10/21, and 6/15/21 During an interview on 7/15/2020 at 4:05 PM, the alternate clinical manager indicated the agency was providing skilled nursing visit, physical therapy and occupational therapy to patient #5, The alternate clinical manager indicated the plan of care had not been returned from the physician and she was unable to locate the orders for therapy and skilled nursing in the patient record. 7. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type two diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had a subsection titles "Orders and Treatments," which stated "SN [skilled nurse] to change suprapubic catheter with 16 Fr [french] 30 cc [catheter] Catheter every 4-6 weeks beginning on 6/10//21...." Review of patient #5 electronic medical record evidenced an agency document tiled "RN [Registered Nurse]-Skilled Visit Note" dated 6/29/21" this document had a subsection titled "Note" which stated #22/30cc catheter changed today as it was leaking: this size was used as it is presently what was used when the patient had it changed in the hospital." The agency failed to follow the physicians order and insert the 16Fr 30cc catheter. During an interview on 7/14/21 at 4:36 PM, the clinical manager indicated there should be an order to change the size of the catheter. The clinical manger failed to provide an updated order to change the catheter size, by end of survey. Review of patient #5 electronic medical record evidenced agency documents titled "RN [Registered Nurse]-Skilled Nursing Visit" dated 5/12/21, 5/25/21, 6/8/21, 6/15/21, 6/22/21 this document had a subsection titled "Wound" which stated "Abdomen cleanse with saline and slotted gauze taped in place." The agency failed to have an order from the physician for this treatment. During an interview on 7/14/21 at 4:37 PM, the clinical manager indicated there was no order to clean the suprapubic site and apply a dressing but she stated "I believe this is protocol." No further information was provided as of the exit conference on 7/15/21. 8. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21, and electronically signed by RN L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]..." This document had an area subtitled "Orders and Treatments" which stated " ... Wound Care Cleanse with betadine [antiseptic], pack both wounds with Iodoform [antiseptic] gauze and cover with DSD [dry sterile dressing]...." Clinical record review evidenced agency documents titled RN-Skilled Nursing Visit," dated 6/25/21, 6/26/21, 6/29/21, 7/2/21, 7/5/21 and 7/7/21 and signed by RN L. These documents had a subsection titled "Wounds Addressed at this Visit" which stated, " ... Treatment Cleanse with normal saline apply black foam secure with tegaderm and attach vac at 125 mmHG...." Clinical record review evidenced agency documents titled RN-Skilled Nursing Visit," dated 7/10/21, and signed by the clinical manager. This document had a subsection titled "Wounds Addressed at this Visit which stated "... Treatment Cleansed with saline black sponge applied KCI VAC drape secured...." Review of patient #1's electronic record failed to evidence an order from the physician for wound vac treatment. During an interview on 7/14/21 at 3:07 PM, the clinical manager indicated there was not an order in patient #1's clinical record for the wound vac treatment. 9. Clinical record review on 7/14/2021 for patient #4, start of care 5/30/20 and a primary diagnosis of Type 2 diabetes [high blood sugar] with chronic kidney disease [disease affecting ability to filter waste], evidenced an agency document titled "OASIS-D1 Recertification", dated 3/31/2021 and digitally signed by RN [registered nurse] E. This document indicated the patient was incontinent (loss of control) of bowel and bladder, difficulty with ambulation, shortness of breath, needs assistance with dressing and was at risk for falls. This document indicated the patient's goals included, but were not limited to, skin to remain intact, will understand proper use of pain medication, maintain 1800 calorie diabetic low salt diet and will be free of signs and symptoms of hypo [low blood sugar]/hyperglycemia [high blood sugar]. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide services 1 time a week for 9 weeks. Review of agency documents titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 3/20/2021, 4/6/2021, 4/15/2021, 4/20/2021 and 4/27/2021 by RN M. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Clinical record review of agency documents failed to evidence a plan of care or physician orders for the care patient #4 received during the certification period of 3/30/21 to 5/24/21. During an interview with the alternate clinical manager on 7/15/21 at 3:55 PM, she indicated she did not see a plan of care for the patient for this certification period. She was unable to locate the physician orders. 17-13-1(a)

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: 3. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an untitled agency document dated 6//27/21 and electronically signed by RN [Registered Nurse] L. This document was a verbal order which stated " Wound Vac to be used starting on 6/25/21, patient will use wet-dry dressing when VAC not being used. SN [skilled nurse] 1w1[once a week for one week]; 3w1 [three times a week for one week] ; 2w1 [twice per week for one week] and 2 PRN [as needed] visits for VAC problem...." This document failed to be authenticated and dated by the physician. During an interview on 7/14/21 at 3:05 PM the clinical manager indicated the order was sent to the physician for signature but had not been returned signed. 4. Clinical record review on 7/13/2021 for patient #5, start of care 5/20/2020, evidenced an agency document titled "OASIS-D1 Start of Care", dated 3/31/2021 and electronically signed by RN M. This document indicated RN M contacted the physician for approval of the plan of care. Review of patient #5's clinical record failed to evidence a plan of care signed by the physician or a verbal order for patient #5 to receive care. During an interview on 7/15/2021 at 3:55 PM the alternate clinical manager indicated there should have been a signed plan of care in the patient's chart, she indicated she did not know why it was not showing in the record. 17-14-1(a)(H) Based on record review and interview, the agency failed to ensure the clinician receiving the physician's verbal orders documented the order in the patient's clinical record to include a signature, date and time of the order and failed to ensure the verbal orders were authenticated and dated by the physician in 3 of 6 active clinical records reviewed. (#1, #5, #6) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Verification of Physician Orders" stated, "... Verbal orders will be spoken to, taken and documented only by a professional, licensed home health personnel ... Orders will be documented within the patient electronic medical record which is dated and signed by the professional receiving the order ... A copy of the physician's order will be kept in the clinical record ... The original of the order will be delivered to the physician for signature. ... Signed orders will be in the clinical record within 30 days of initiation of care or interim order." 2. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021 and digitally signed by (registered nurse) RN L. This document indicated RN L contacted the physician for approval of the plan of care. Review evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021 which failed to evidence the signature and date of RN L for the verbal start of care and physician orders contained in the plan of care. During an interview on 7/13/2021 at 3:39 PM, the clinical manager indicated the nurse case manager still needed to review the plan of care before it could be signed by the nurse and send it to the physician for signature.

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: 3. Clinical record review on 7/14/2021 for patient #5, start of care 5/30/20, and a primary diagnosis of Type 2 diabetes [high blood sugar] with chronic kidney disease [disease affecting ability to filter waste], evidenced an agency document titled "OASIS-D1 Recertification", dated 3/31/2021, and digitally signed by RN [registered nurse] E. This document indicated the patient was incontinent [loss of control] of bowel and bladder, difficulty with ambulation, shortness of breath, needs assistance with dressing and was at risk for falls. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide services 1 time a week for 9 weeks. Clinical record review failed to evidence a plan of care for the physician to review for certification period 3/30/21 to 5/24/21. During an interview on 7/15/21 at 3:55 PM, the alternate clinical manager indicated she was unsure as to why there was not a plan of care for this certification period 17-13-1(a)(2) Based on record review and interview, the agency failed to ensure the individualized plan of care was reviewed by the physician at least every 60 days in 2 of 6 active clinical records reviewed. (#2, #5) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Physician Participation in Plan of Care" stated, "... The attending physician will sign the plan of care/treatment within 30 days of the start of care. ... The attending physician's recertification will be obtained in intervals of at least every 60 days when the patient's plan of care is reviewed, the patient recertified, and more often, if warranted...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient was incontinent (loss of control) of bowel and bladder, dependent for grooming, dressing, bathing, toileting and required assistance with ambulation and was at risk for falls. This document indicated the patient's goals included, but were not limited to, skin to remain intact, achieve a pain level less than 4 out of 10 and maintain ADL (activities of daily living) status. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide (HHA) services 1 time a week for 9 weeks. Review evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period of 12/16/2020 - 2/13/2021, which was signed by physician L on 12/30/2020. Review failed to evidence the physician reviewed the plan of care since 12/30/2020. During an interview on 7/14/2021 at 3:53 PM, office coordinator D indicated she had called the office of physician L regarding the unsigned physician orders and the physician's office informed office coordinator D there was no record of the patient at the physician's office. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated the last plan of care signed by the physician was on 12/30/2020.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: 8. Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN [registered nurse]-Skilled Visit Note", dated 6/23/21, and signed by RN L. This document had a subsection titled "Wounds Assessed on this Visit," which stated, "Wound 1-Location R [right] foot top of 2nd toe Status: open, Present on admission Thickness: Full Type Diabetic Size: Length 1 cm [centimeter] Width 3.0 cm Depth 1.5 cm Woundbed white, pink/red 10% Wound edges: non-attached...." Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN-Skilled Visit Note", dated 6/25/21, and signed by RN L. This document had a subsection titled "Wounds Assessed on this Visit," which stated, Wound 1-Location R foot top of 2nd toe Status: open, Present on admission Thickness: Full Type Diabetic Size: Length 1 cm Width 3.0 cm Depth 1.5 cm Woundbed, pink/red 60% Wound edges: non-attached...." Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN-Skilled Visit Note", dated 6/26/21, and signed by RN L. This document had a subsection titled "Wounds Assessed on this Visit" which stated Wound 1-Location R foot top of 2nd toe Status: open, Present on admission Thickness: Full Type Diabetic Size: Length 1 cm Width 3.0 cm Depth 1 cm Woundbed pink , pink/red 40% Wound edges: epithaelization [cells are repairing the wound]...." Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN-Skilled Visit Note", dated 6/29/21, and signed by RN L. This document had a subsection titled "Wounds Assessed on this Visit" which stated Wound 1-Location R foot top of 2nd toe Status: open, Present on admission Thickness: Full Type Diabetic Size: Length 1 cm Width 3.0 cm Depth 01.0 cm Wounded pink , pink/red 40% Wound edges: epithaelization...." Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN-Skilled Visit Note", dated 7/2/21, and signed by RN L. This document had a subsection titled "Wounds Assessed on this Visit" which stated Wound 1-Location R foot top of 2nd toe Status: open, Present on admission Thickness: Full Type Diabetic Size: Length 2 cm Width 2 cm Depth 0.8 cm Woundbed pink , pink/red 40% Wound edges: epithaelization...." Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN-Skilled Visit Note", dated 7/5/21 and signed by RN L. This document had a subsection titled "Wounds Assessed on this Visit" which stated Wound 1-Location R [right] foot top of 2nd toe Status: open, Present on admission Thickness: Full Type Diabetic Size: Length 2 cm [centimeter] Width 1.5 cm Depth 0.7 cm Woundbed pink , pink/red 40% Wound edges: non-attached...." Review of patient #1's electronic record failed to evidence the physician was informed of the changes to patient #1's wound. During an interview on 7/14/2021 at 2:35 PM, the clinical manager indicated the patients physician should have been contacted of the changes to the wound, but she did not see that it was documented in the patient's record. 9. Clinical Record review on 7/13/21 for patent #4, start of care 5/30/2020, evidenced an agency document titled "RN-Skilled Nursing Visit" electronically signed by RN M and dated 5/3/21. This document had a subsection titled "Respiratory" which stated "Lung sounds Wheezes: L[left] mid [middle] lung field ... Cough: Productive Sputum: Amount: mod [moderate] amts [amounts] and odor" frothy white...." Clinical Record review on 7/13/21 for patent #4, start of care 5/30/2020, evidenced an agency document titled "RN-Skilled Nursing Visit" electronically signed by RN E and dated 6/14/21. This document had a subsection titled "Respiratory" which stated "Lung sounds Wheezes: Diminished: Bases...." Clinical Record review on 7/13/21 for patent #4, start of care 5/30/2020, evidenced an agency document titled "RN-Skilled Nursing Visit" electronically signed by LPN C and dated 6/25/21. This document had a subsection titled "Respiratory" which stated " ... Cough: Nonproductive...." Clinical Record review on 7/13/21 for patent #4, start of care 5/30/2020, evidenced an agency document titled "RN-Skilled Nursing Visit" electronically signed by LPN C and dated 7/8/21. This document had a subsection titled "Respiratory" which stated " ... Cough: Nonproductive...." Clinical Record review on 7/13/21 for patent #4, evidenced agency documents titled "RN-Skilled Nursing Visit" electronically signed by RN M and dated 4/6/21 and 4/27/21. This document had a subsection titled "Cardiovascular" which stated " ... Edema [swelling] R [right] ankle +2 L [left] ankle +2 ... Comments: instr [instruct] pt [patient] to elevate her legs during the day to alleviate bilateral ankle edema...." Clinical Record review on 7/13/21 for patent #4, evidenced an agency document titled "RN-Skilled Nursing Visit" electronically signed by RN M and dated 5/3/21. This document had a subsection titled "Cardiovascular" which stated " ... Edema L ankle R ankle +1 ... Comments: instr pt to elevate her legs during the day to alleviate bilateral ankle edema...." Clinical Record review on 7/13/21 for patent #4, evidenced agency documents titled "RN-Skilled Nursing Visit" electronically signed by RN M and dated 3/30/21, 4/6/21 and 4/15/21. This document had a subsection titled "Pain" which stated " ... "Frequency of pain interfering with patients activity or movement: Daily, but not constantly Primary Site: lower back pain intensity 6 [on a scale where 0 is no pain 10 is the worst pain] pain management effectiveness: fair Progress towards pain goal: fair Comments: instr pt to take pain me [medication] at the first signs of pain...." Clinical Record review on 7/13/21 for patent #4, evidenced agency documents titled "RN-Skilled Nursing Visit" electronically signed by RN M and dated 4/6/21 and 5/3/21. This document had a subsection titled "Pain" which stated " ... "Frequency of pain interfering with patients activity or movement: Daily, but not constantly Primary Site: lower back pain intensity 7 pain management effectiveness: fair Progress towards pain goal: fair Comments: instr pt to take pain me [medication] at the first signs of pain...." Clinical record review of patient #4's electronic medical record failed to evidence the physician was notified of the patient's pain levels, edema and cough. During an interview on 7/14/21 at 2:53 PM, the clinical manager indicated the physician should be notified, but she did not see the notification documented in the patient's clinical record. 10. Clinical record review on 7/13/2021 for patient #5, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, Essential Primary Hypertension [high blood pressure] ... This document had an area subtitled "Orders and Treatments" which stated "SN 2w4, 1w5 PT [physical therapy] 1w1, OT [Occupational therapy 1w1...." Clinical record review for patient #5 evidenced an undated document titled "Missed Visit" which stated " ... Discipline OT Date(s) of Missed Visit 6/10/2021 ... Pt stated he was in too much pain...." There failed to be evidence the patient's primary care physician was notified of his pain and the missed visit. Clinical record review for patient #5 evidenced an undated document titled "Missed Visit" which stated " ... Discipline OT 6/29/2021 ... Date(s) of Missed Visit 6/22/21 & 6/24/21 ... Pt stated he was in too much pain ...." There failed to be evidence the patient's primary care physician was notified of his pain and the missed visit. Clinical record review for patient #5 evidenced an undated document titled "Missed Visit" which stated " ... Discipline OT 6/29/2021 ... Date(s) of Missed Visit 6/29/21 & 7/1/21 ... Pt stated he is waiting to get a pain shot to continue therapy...." There failed to be evidence the patient's primary care physician was notified of his pain and the missed visit. 17-13-1(a)(2) Based on record review and interview, the agency failed to promptly alert the physician to changes in the patient's condition or needs that suggested that outcomes were not being achieved and/or alert the physician the plan of care should be altered in 6 of 8 complete clinical records reviewed (#1, #2, #4, #5, #6, #7) and 2 of 2 partial clinical records reviewed. (#9, #10) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Care Planning Process" stated, "... Clinicians will inform the patient's physician of any changes that suggest a need to alter the plan of care...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Adverse Drug Reactions" stated, "... All adverse drug reactions will be promptly reported to the patient's physician in order to minimize patient's health risks and discomfort...." 3. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced agency documents titled "RN - Skilled Nursing Visit". Review of documents, dated 4/21/2021 and 4/28/2021, failed to indicate a concern with the patient's appetite and nutritional status. Review of document dated 5/12/2021, and digitally signed by RN E, indicated the patient had poor appetite and poor nutrition. Review failed to evidence the physician was notified regarding the change in nutritional status. During an interview on 7/15/2021 at 12:56 PM, the alternate clinical manager indicated the nurse should have notified the physician, but did not see any physician notification regarding the nutritional status. 4. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021 and digitally signed by registered nurse (RN) L. This document indicated the patient had a Stage III pressure wound (a type of wound which typically develops when soft tissue is compressed between a bony prominence and an exterior surface for an extended period of time resulting in full thickness skin loss) to the right heel measuring 4.5 centimeters (cm) in length, 5.7 cm in width and 0.5 cm in depth with moderate serous (clear to slightly yellow in color) drainage and with an odor present. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021, which stated, "... Report to physician ... increased [sic] in drainage, foul odor ... and other significant changes...." Review of agency documents titled "RN - Skilled Nursing Visit", dated 7/5/2021 and 7/7/2021, and digitally signed by RN L, indicated the patient's pressure wound to the right heel had a foul odor. The document failed to evidence the physician was contacted. Document dated 7/10/2021, and digitally signed by the clinical manager indicated the pressure wound to the right heel was 4.0 cm in length, 6.5 cm in width, 0.5 cm in depth with greenish drainage and a foul odor. The document indicated the physician was contacted regarding wound drainage and the patient was to make an appointment with the physician. During an interview on 7/13/2021 at 9:03 AM, nurse H at the office of physician I, indicated there was no communication in the physician's office record regarding the patient's wound and no communication with the home care agency. Nurse H indicated the physician's office was not open on 7/10/2021, and there was no message left regarding the patient's wound from the home care agency. During an interview on 7/13/2021 at 10:45 AM, the clinical manager indicated she believed the patient would end up needing intravenous antibiotics (medication used to treat infection and administered through a needle inserted into the patient's bloodstream) because the wound was not healing. The clinical manager indicated the patient may end up needing to go to a wound clinic. At 3:37 PM, the clinical manager indicated she did not call to inform the physician on 7/10/2021, regarding the wound but rather on 7/12/2021. When queried why the physician communication was documented as completed on 7/10/2021, the clinical manager indicated it was a documentation error. When queried what wound information was communicated to the physician on 7/12/2021 and where it was documented, the clinical manager indicated she could not recall if the physician was contacted regarding the patient's wound. 5. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 3/9/2021, and digitally signed by RN I. This document stated, "... Patient prescribed clindamycin [antibiotic] for gum infection, took approximately 6 doses with N/V [nausea and vomiting] and chest pain. Patient was seen in ER [emergency room] on 3/6/2021, with no changes in orders, clindamycin stopped and dentist calling in new prescription...." Review failed to evidence the primary physician was notified of the patient's visit to the emergency room for the medication reaction to the clindamycin, the gum infection and the initial order for clindamycin. During an interview on 7/13/2021 at 4:40 PM, the clinical manager indicated the physician should have been notified of the gum infection, the clindamycin order and the patient's emergency room visit and treatment for the reaction to the clindamycin. The clinical manager indicated there was not any communication with the physician documented in the record. Review evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, signed by RN I and the physician. This document indicated the patient was to receive home health aide services 2 times a week for 8 weeks and then 1 time a week for 1 week beginning the week of 2/28/2021. Review failed to evidence home health aide services were provided after 3/31/2021. Review failed to evidence the patient's medication included clindamycin. This document indicated the nutritional orders were for a heart healthy, easy to chew diet. During an interview on 7/13/2021 at 4:30 PM, the clinical manager indicated the last home health aide visit was on 3/31/2021, because the home health aide "fell off the face of the Earth." The clinical manager indicated there was not any communication to the physician, but he should have been made aware the patient's need for home health aide services were not being met. Review of an agency document titled "RN-Skilled Nursing Visit", dated 3/16/2021, and digitally signed by RN I, indicated the patient had been hospitalized from 3/11/2021 to 3/14/2021, for a large hernia. This document stated, "... Educated on using thickened liquids as daughter states patient 'spits up' after meals...." Review failed to evidence the physician was contacted regarding the caregiver's report the patient was spitting up after meals or requiring thickened liquids. During an interview on 7/13/2021 at 4:43 PM, the clinical manager stated, "I don't see the physician was notified." 6. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021, and digitally signed by RN L, which indicated the patient's diagnoses were Parkinson's disease and hypertension (high blood pressure). Review evidenced the patient lived alone, ate mostly frozen meals and a referral was needed to a medical social worker (MSW) for housing choices. Review indicated the patient was at risk for falls and had difficulty with ambulation, limited mobility and poor balance. The document stated, "... has frequent falls. She lives in 1 room of a house ... has to climb 4 stairs to garage to access the refrigerator and microwave...." Review indicated the agency services were to include skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/15/2021 - 8/13/2021, signed and dated by the nurse practitioner on 7/15/2021, indicated the orders for services included skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review failed to evidence the patient had received any skilled nursing, PT, OT and MSW services and failed to evidence any communication with the physician regarding skilled nursing services, OT and MSW services not provided as ordered. During an interview on 7/15/2021 at 2:22 PM, the alternate clinical manager indicated the agency was unable to reach the patient and staff should contact the clinical manager when unable to contact the patient "so it's on our radar." The alternate clinical manager indicated sometimes the agency will call the local authorities to conduct a well visit when unable to reach a patient, but it was not agency policy that it had to be done. During an interview on 7/15/2021 at 2:24 PM, office coordinator D indicated she just received an email from therapy company C regarding communication with the patient and a scheduled PT evaluation. Office coordinator indicated she had just entered the information into the clinical record regarding the message from therapy agency C. Review of an agency document titled "Patient Notes/Messages", dated 7/15/2021, and entered by office coordinator D, indicated there was a therapy services update and noted a document attachment. Review of an agency document titled "Narrative Note", dated 7/7/2021, and electronically signed by PT P, which indicated therapy company C had difficulty reaching the patient to schedule initial PT evaluation, but was now scheduled for 7/15/2021. Review failed to evidence any communication regarding PT services until communication with therapy agency C on 7/15/2021. During an interview on 7/15/2021 at 2:24 PM, when queried why therapy agency C had made patient contact but the agency had not, the alternate clinical manager indicated a missed visit note in the clinical record on 6/30/2021, indicated the nurse attempted to call the patient but there was no answer. The alternate clinical manager indicated there was no communication from the agency regarding attempts to contact the patient since 6/30/2021. At 2:35 PM, the alternate clinical manager indicated office coordinator D usually sent the referrals for MSW services and indicated there was no communication regarding MSW services for the patient. The alternate clinical manager asked office coordinator D if a MSW referral was sent to agency D, office coordinator D stated, "No one has told me to contact [agency D] for a MSW referral." 7. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021, and digitally signed by RN L. This document indicated the patient's diagnoses included, but were not limited to: neck muscle strain, right lower leg contusion (bruise), Parkinson's disease, spinal stenosis (narrowing of the spaces within the spine putting pressure on the nerves) and diabetes (a chronic disease affecting how the body uses blood sugar). Review indicated the patient was at risk for falls, had difficulty with ambulation requiring the use of a cane and had poor balance. This document indicated the patient required assistance with dressing the lower body and bathing and stated, "... [patient] has not been taking a shower last few months, gait to [sic] unsteady and no one to assist him ... Has several stairs leading outside, he fell yesterday down these stairs; needs assistive device and assist to leave home ...." Review indicated the patient was to receive home health aide services 1 time a week for 9 weeks. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 4/15/2021 - 6/13/2021, signed and dated by the physician on 4/21/2021, indicated the orders for agency services included home health aide services 1 time a week for 9 weeks. Review failed to evidence the patient had received any home health aide services and failed to evidence communication with the physician regarding the home health aide services not provided. During an interview on 7/15/2021 at 5:05 PM, the alternate clinical manager indicated there was no record of home health aide services provided to the patient and no communication in the record why home health aide services were not provided.

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to revise the plan of care to reflect current health status and nursing needs in 4 of 8 complete clinical records reviewed. (#1, #6, #7, #8) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... The plan of care will be based upon the physician's (or other authorized licensed independent practitioner's) orders and will encompass the equipment, supplies, and services required to meet the patient's needs. ... The plan of care will be revised as frequently as deemed necessary by the clinicians based on the ongoing assessments of the patient. ... Changes in the plan of care will be noted with the following documentation: ... Assessment ... Verbal orders ... Changes must be written, dated and signed by the professional making the changes...." 2. Clinical record review on 7/13/2021 for patient #6, start of care 12/29/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021, which indicated the patient was to receive physical therapy (PT) services 1 time a week for 1 week. Review of an agency document titled "PT Evaluation", dated 6/28/2021, and digitally signed by PT G, indicated the patient was to receive PT services 2 times a week for 4 weeks. The plan of care failed to be revised to evidence the patient's change in PT services frequency. 3. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Physician Order", dated 2/27/2021, signed by registered nurse I and the physician. This document indicated the patient was to have the following tests performed weekly: CBC (complete blood count; a group of tests run from a blood sample that evaluate the cells that circulate in the blood), CMP (comprehensive metabolic panel; a test run from a sample of blood used to determine 14 different measurements which evaluate liver function, kidney function and nutrient levels), Magnesium (a blood test used to determine the amount of magnesium in the blood), Phosphorous (a blood test used to determine the amount of phosphorous in the blood) and a urine analysis (a lab test used to detect and substances in the urine). Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, signed by registered nurse I and the physician, indicated the patient was to have a BMP (basic metabolic panel; a group of tests run from a sample of blood to determine 8 different measurements), Magnesium, Phosphorous and urine analysis weekly, but failed to evidence the plan of care was revised to include the physician's order for a CBC and CMP to be obtained weekly. This document indicated the nutritional orders were for a heart healthy, easy to chew diet. Review evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 3/9/2021, and digitally signed by RN I. This document stated, "... Patient prescribed clindamycin [antibiotic] for gum infection, took approximately 6 doses with N/V [nausea and vomiting] and chest pain. Patient was seen in ER [emergency room] on 3/6/2021 with no changes in orders, clindamycin stopped and dentist calling in new prescription...." The plan of care failed to be revised to indicate the patient's diagnosis of a gum infection and antibiotic. During an interview on 7/13/2021 at 4:40 PM, the clinical manager indicated the plan of care should have been revised to indicate the patient's change in status to include the diagnosis of the gum infection and new antibiotic. Review of an agency document titled "RN-Skilled Nursing Visit", dated 3/16/2021, and digitally signed by RN I, indicated the patient had been hospitalized from 3/11/2021 to 3/14/2021, for a large hernia. This document stated, "... Educated on using thickened liquids as daughter states patient 'spits up' after meals...." Review failed to evidence the plan of care was revised to include the patient's nutritional need for thickened liquids. During an interview on 7/13/2021 at 4:46 PM, the clinical manager indicated the plan of care should have been revised to reflect the patient's requirement of thickened liquids. 4. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 4/12/2021 - 6/10/2021, which indicated the patient was to receive physical therapy (PT) services 1 time a week for 1 week. Review of an agency document titled "Physical Therapy Evaluation", dated 4/21/2021, and electronically signed by PT N, indicated the patient was to receive PT services 1 time a week for 1 week and then 2 times a week for 7 weeks. This document indicated the patient's goals included improve sit to stand transfer, improve bed to chair transfer, improve standing, to walk up to 350 feet with rolling walker and improve muscle strength to lower extremities. The plan of care failed to be revised to evidence the patient's change in PT services frequency and PT goals. 5. During an interview on 7/13/2021 at 3:14 PM, the clinical manager indicated the plan of care should be updated with any changes. 6. During an interview on 7/13/2021 at 3:17 PM, the alternate clinical manager indicated the patient's plan of care was the 485. The alternate clinical manager indicated the therapy evaluation was not the patient's plan of care. 7. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21, and electronically signed by RN L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]..." This document had an area subtitled "Orders and Treatments" which stated " ... "Wound Care Cleanse with betadine [antiseptic], pack both wounds with Iodoform [antiseptic] gauze and cover with DSD [dry sterile dressing]...." This plan of care failed to be updated with patient #1's current wound treatment During a home visit on 7/13/21 at 9:30 AM, RN E was observed changing a wound vac dressing to patient #1's right foot. Clinical record review on 7/13/21, evidenced agency documents titled RN-Skilled Nursing Visit," dated 6/25/21, 6/26/21, 6/29/21, 7/2/21, 7/5/21, 7/7/21, and signed by RN L. These documents had a subsection titled "Wounds Addressed at this Visit," which stated, " ... Treatment Cleanse with normal saline apply black foam secure with tegaderm [transparent dressing] and attach vac at 125 mmHG [millimeter mercury]...." During an interview on 7/14/21 at 2:55 PM, the clinical manager indicated the plan of care should have included an addendum with the updated treatment plan. 17-14-1(a)(1)(C)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care of services provided to the patient in 4 of 8 complete clinical records reviewed (#1, #3, #6, #7) and 2 of 2 partial clinical records (#9, #10) reviewed. The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Coordination of Services with Other Providers" stated, "... A Case Manager will be assigned to be responsible for coordinating services provided to the patient by the organization, including services provided directly and through contract. The Case Manager will act as liaison with other organizations or individuals also providing care to the patient to assure effective coordination of related services...." 2. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021, and digitally signed by RN L. This document indicated the nurse assessed the patient to have Grade 1 edema (pressure applied to the skin leaves an indentation of 0-2 millimeters (mm) that rebounds immediately) to the right foot. Review of an agency document titled "PT [physical therapy] Evaluation", dated 6/28/2021, and digitally signed by PT G, indicated the patient was assessed to have Grade 2 (pressure applied to the skin leaves an indentation of 2-4 mm that rebounds in fewer than 15 seconds) to the right foot and leg. Review failed to evidence the PT notified the nurse case manager regarding the change in edema. During an interview on 7/15/2021 at 9:56 AM, the alternate clinical manager indicated the change in edema should have been communicated to the nurse case manager, but did not see that it was. 3. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Physician Order", dated 2/27/2021, signed by registered nurse I and the physician. This document indicated the patient was to have blood tests and a urine test completed weekly. Review failed to evidence the agency obtained blood and urine tests for the weeks of 3/7/2021 and 3/28/2021, and failed to evidence care coordination regarding the laboratory tests not being obtained. During an interview on 7/13/2021 at 4:13 PM, the clinical manager indicated the agency received the order for blood and urine tests, but contracted with entity F to obtain the tests. The clinical manager indicated there was not any care coordination with entity F regarding the blood and urine test results for the weeks of 3/7/2021 and 3/28/2021. 4. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021, and digitally signed by RN L, which indicated the patient's diagnoses were Parkinson's disease and hypertension (high blood pressure). Review evidenced the patient lived alone, ate mostly frozen meals and a referral was needed to a medical social worker (MSW) for housing choices. Review indicated the patient was at risk for falls and had difficulty with ambulation, limited mobility and poor balance. The document stated, "... has frequent falls. She lives in 1 room of a house ... has to climb 4 stairs to garage to access the refrigerator and microwave...." Review indicated the agency services were to include skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/15/2021 - 8/13/2021, signed and dated by the nurse practitioner on 7/15/2021, indicated the orders for services included skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review failed to evidence the patient had received any skilled nursing, PT, OT and MSW services and failed to evidence any communication regarding skilled nursing services, OT and MSW services. During an interview on 7/15/2021 at 2:22 PM, the alternate clinical manager indicated the agency was unable to reach the patient and staff should contact the clinical manager when unable to contact the patient "so it's on our radar." The alternate clinical manager indicated sometimes the agency will call the local authorities to conduct a well visit when unable to reach a patient, but it was not agency policy that it had to be done. Review of an agency document titled "Patient Notes/Messages", dated 7/15/2021, and entered by office coordinator D, indicated there was a therapy services update and noted a document attachment. During an interview on 7/15/2021 at 2:24 PM, office coordinator D indicated she just received an email from therapy company C regarding communication with the patient and a scheduled PT evaluation. Office coordinator indicated she had just entered the information into the clinical record regarding the message from therapy agency C. Review of an agency document titled "Narrative Note", received on 07/15/2021, from office coordinator D and dated 7/7/2021, electronically signed by PT P, indicated therapy company C had difficulty reaching the patient to schedule initial PT evaluation, but was now scheduled for 7/15/2021. Review failed to evidence any communication regarding therapy agency C having a difficult time contacting the patient for a PT evaluation until communication with therapy agency C on 7/15/2021. During an interview on 7/15/2021 at 2:24 PM, when queried why therapy agency C had made patient contact, but the agency had not, the alternate clinical manager indicated there was a missed visit note in the clinical record on 6/30/2021, which indicated the nurse attempted to call the patient but there was no answer. The alternate clinical manager explained there was no communication from the agency regarding attempts to contact the patient since 6/30/2021. At 2:35 PM, the alternate clinical manager indicated office coordinator D usually sent the referrals for MSW services and indicated there was no communication regarding MSW services for the patient. The alternate clinical manager asked office coordinator D if a MSW referral was sent to agency D, office coordinator D stated, "No one has told me to contact [agency D] for a MSW referral." 5. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021, and digitally signed by RN L. This document indicated the patient's diagnoses included, but were not limited to: neck muscle strain, right lower leg contusion (bruise), Parkinson's disease, spinal stenosis (narrowing of the spaces within the spine putting pressure on the nerves) and diabetes (a chronic disease affecting how the body uses blood sugar). Review indicated the patient was at risk for falls, had difficulty with ambulation requiring the use of a cane and had poor balance. This document indicated the patient required assistance with dressing the lower body and bathing and stated, "... [patient] has not been taking a shower last few months, gait to [sic] unsteady and no one to assist him ... Has several stairs leading outside, he fell yesterday down these stairs; needs assistive device and assist to leave home ...." Review indicated the patient was to receive home health aide services 1 time a week for 9 weeks. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 4/15/2021 - 6/13/2021, signed and dated by the physician on 4/21/2021, indicated the orders for agency services included home health aide services 1 time a week for 9 weeks. Review failed to evidence the patient had received any home health aide services and failed to evidence coordination of care regarding the inability to staff home health aide services with the clinical manager and the primary care physician. During an interview on 7/15/2021 at 5:05 PM, the alternate clinical manager indicated there was no record of home health aide services provided to the patient and no communication in the record why home health aide services were not provided. 6. Clinical record review on 7/14/21, for patient #1, with start of care 6/9/21,evidenced a document signed by the physician on 6/23/21, titled "HOME HEALTH CERTIFICATION AND PLAN OF CARE" for certification period 6/9/21 to 8/7/21. This document contained a category titled, " Primary Diagnosis" which stated, " ... Type 2 diabetes mellitus [high blood sugar] with foot ulcer [open sore] ... non chronic ulcer right foot ... a subsection "Orders and Treatments" stated "Wound Care : cleanse with betadine [antiseptic] , pack both wounds with iodoform [antiseptic dressing] gauze and cover with DSD [dry sterile dressing]...." During a home visit for patient #1 on 7/13/2020 at 9:26 AM, an interview ensued and patient #1 indicated he has been seen weekly by the wound clinic. When queried as to how often the staff was coming to see him, he indicated sometimes he has to call the home care agency out to put his wound vac back on because the clinic does not do that. During this visit the RN told the patient they may discontinue the wound vac at his next visit to the wound clinic. Clinical record review of patient #1's electronic record failed to evidence any coordination of care with a wound clinic. During an interview on 7/14/21 at 3:22 PM the clinical manager indicated she did not see any documentation of coordination with the wound care clinic in patient #1's clinical record. 7. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document unsigned by the physician titled "HOME HEALTH CERTIFICATION AND PLAN OF CARE" for certification period 5/10/2021 - 7/8/2021. This document contained a subsection titled "Secondary/Other Diagnosis, " which stated, "chronic kidney disease [disease of the organs that filter waste from the body] ... end stage renal disease [organs not filtering waste from the body]...." there was a subsection titled "Orders and Treatments," which stated, " ... has a history of IDDM [insulin dependant diabetes mellitus], CHF [congestive heart failure], CVA [cerebral vascular accident], A-Fib [atrial fibrillation] and ESRD [end state renal disease] on dialysis...." Clinical record review of patient #3's electronic record failed to evidence any coordination of care with the dialysis center. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated there would not be any coordination of care with the dialysis center, they do not usually coordinate care with them. 17-12-2(h)

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure the written visit schedule was provided to patients in 3 of 3 home visit patients observed (#1, #4, #6) The findings include: 1. An agency policy titled "CARE PLANNING PROCESS" revised November 2017 stated " ... 16. The organization shall provide the patient and caregiver with a copy pf written instructions outlining: A. Visit schedule, including the frequency of visits by personnel and personnel acting on behalf of the organization...." 2. Observation of a home visit for patient #1 on 7/13/2021 at 9:26 AM, failed to evidence a written visit schedule was provided to the patient, from the home health agency. During an interview on 7/13/2021 at 10:13 AM, RN [registered nurse] E, caregiver to patient #1, indicated she did not see a calendar in his folder. She informed patient #1 to call the office to schedule his next appointment after seeing the physician. During an interview on 7/13/2021 at 10:22 AM, patient #1 indicated he does not have a calendar from the agency they just tell him when the next time they will be coming to the house will be. During an interview on 7/14/2021 at 4:05 PM, the clinical manager indicated the agency failed to provide written visit schedules to their patients. 3. Observation of a home visit for patient #4 on 7/15/2020 at 12:01 PM, failed to evidence a written visit schedule provided to the patient, from the home health agency. During an interview on 7/15/2021 at 12:22 PM, patient #4 indicated she does not have a calendar from the agency. During an interview on 7/15/2021 at 2:05 PM, the assistant clinical manager indicated she would look into why the visit calendar was not in the patient's home. 4. During an observation of care at the home for patient #6, start of care 6/25/2021, on 7/13/2021 at 4:18 PM, the agency's home folder was reviewed which failed to evidence a calendar of services the patient was to receive from the agency. During an interview on 7/15/2021 at 9:43 AM, the alternate clinical manager indicated she did not believe the agency provided the patients with a written schedule of the services the patient was to receive. The alternate clinical manager indicated the staff informed the patient of their visits by calling the patient the night prior to their visit and gave the patient a 2 hour window of when staff would be at the patient's home the next day.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: 4. Clinical record review on 7/14/21 for patient #4, start of care 5/30/21, evidenced an agency document titled "Plan of Care," signed by RN E dated 5/24/21, and signed by physician G, which had a subsection titled "Medications," which stated Lasix [treats fluid retention] Oral 40 MG 1 tab (s) every other day with 20 mg Tylenol Extra strength Oral 500 MG 1 tab (s) daily prn Pain Vitamin D [supplement] 500 MCG 1 Tab (s) po 2X daily Vitamin B12 [supplement] oral 50 MCG 1 tab (s) po daily ALPRaZolam [treats anxiety] Oral 2.5 MG 1 tab (s) po daily Bismuth Subsalicylate [treats upset stomach] Oral 262 1 Tab (s) po 2X daily Furosemide [treats water retention] Oral 20 MG 1 Tab (s) every other day alternating with mg Gabepentin [treats nerve pain] Oral 300 mg 1 cap [capsule] po daily Docusate Sodium [stool softener] Oral 100 MG 1 Cap (s) po daily prn for constipation Levothyroxine Sodium [ treats thyroid disease] Oral 50 MCG 1 Tab (s) po daily Lisinopril [for high blood pressure] Oral 5 MG 1 Tab (s) po daily Magnesium Oxide [supplement] Oral 400 MG 1 Tab (s) po daily metFORMIN HCl [treats high blood sugar] Oral 500 MG 1 Tab (s) po daily Norco Oral 7.5-325 MG 1 tab (s) po 2x daily prn for pain Pantoprazole Sodium [for stomach acid] Oral 40 MG 1 Tab (s) po daily Slow Fe [iron supplement] Oral 143 (45 Fe) MG 1 tab (s) po Daily Trazadone [for sleep] HCl Oral 50 MG 1 Tab (s) po daily Tylenol Extra strength Oral 500 MG 1 tab (s) daily prn pain Vitamin D 500 MCG 1 Tab (s) po 2X daily Vitamin B12 oral 50 MCG 1 tab (s) po daily ALPRaZolam Oral 2.5 MG 1 tab (s) po daily AmLODIPine Besylate Oral 2.5 MG 1 Tab (s) po daily Bismuth Subsalicylate Oral 262 1 Tab (s) po 2X daily Furosemide Oral 20 MG 1 Tab (s) every other day alternating with mg Gabepentin Oral 300 mg 1 cap [capsule] po daily Docusate Sodium Oral 100 MG 1 Cap (s) po daily prn for constipation Levothyroxine Sodium Oral 50 MCG 1 Tab (s) po daily Lisinopril Oral 5 MG 1 Tab (s) po daily Magnesium Oxide Oral 400 MG 1 Tab (s) po daily metFORMIN HCl Oral 500 MG 1 Tab (s) po daily Norco Oral 7.5-325 MG 1 tab (s) po 2x daily prn for pain Pantoprazole Sodium Oral 40 MG 1 Tab (s) po daily Slow De Oral 143 (45 Fe) MG i tab (s) po Daily Trazadone HCl Oral 50 MG 1 Tab (s) po daily...." During a home visit on 7/15/21 at 12:04 PM, an agency folder was observed on the patients table. The folder did not contain a medication schedule for patient #4. During an interview on 7/15/21 at 12:16 PM, patient #4 indicated she had a medication list she wrote and follows. She had a folder from the agency, but there was no medication list contained in the folder. During an interview on 7/15/21 at 3:54 PM, the alternate clinical manager indicated she would make sure the patient had a written medication schedule, she was unsure why there was not one at the home. 5. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21, and electronically signed by RN L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure] ... There was a subsection titled "Medications." which stated, "Glimepride Oral 4 MG 1 Tab (s) Daily hydriCHLOROthiazide Oral 25 MG 1 Tab (s) Daily Metoprolol Tartrate Oral 50 MG 1 TAb (s) Twice Daily metFORMIN HCl Oral 500 MG 2 Tab (s) Twice Daily Doxycycline Hyclate Oral 100 MG 1 Cap (s) Twice Daily AmLODIPINE Besylate Oral 10 MG 1 Tab (s) Daily...." During an interview on 7/13/2021 at 10:02 AM, patient #1 indicated the agency never gave him a written medication list. During an interview on 7/15/21 at 2:52 PM, the alternate clinical manager indicated she would make sure the patient has a written medication schedule, she was unsure why there was not one at the home. Based on observation, record review and interview, the agency failed to provide written instructions to the patient for the patient's medication schedule and instructions in 3 of 3 home visits conducted. (#1, #4, #6) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Medication Profile" stated, "... Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications ... the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver as well as other clinicians understand the medication regimen. ... Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the medication...." 2. During an observation of care at the home of patient #6, start of care 6/25/2021, on 7/14/2021 at 4:18 PM, an agency folder was reviewed which failed to evidence a medication profile or plan of care with the patient's medication listed with written instructions. 3. During an interview on 7/15/2021 at 9:45 AM, the alternate clinical manager indicated the skilled nurse should write down the medication instructions on the medication profile in the agency folder in the patient's home and review the medication profile and provide medication education at every visit.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the quality assurance and performance improvement (QAPI) program: failed to measure, analyze and track quality indicators and other aspects of performance that enable the agency to assess processes of care, agency services and operations and failed to show measurable improvement in indicators which will improve health outcomes, patient safety and quality of care (see tag G0642); failed to monitor the effectiveness and safety of services and quality of care and identify opportunities for improvement (see G0644); failed to focus on high risk areas (see tag G0648); failed to ensure the performance improvement activities considered incidence, prevalence and severity of problems (see tag G0650); failed to ensure the performance improvement activities tracked adverse patient events, analyzed their causes and implemented preventative actions. (see tag G0654); failed to conduct performance improvement projects (see G0658) and failed to ensure an ongoing program for quality improvement and patient safety is defined, implemented and maintained and agency-wide QAPI efforts which addressed priorities for improved quality of care and patient safety and improvement actions were evaluated for effectiveness (see tag G0660). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the condition of participation 484: 65 Condition: Quality Assessment / Performance Improvement.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to measure, analyze and track quality indicators, including adverse patient events and other aspects of performance that enable the agency to assess processes of care and agency services and failed to show measurable improvement in indicators which will improve health outcomes, patient safety and quality of care. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Aggregation of Data/Information" stated, "... Data to be considered for collection to monitor performance of the organization include the following: ... Summaries of incidents ... Appropriateness and effectiveness of pain management ... Care or services provided to high-risk populations ... Information about incidents ...." Request made to the clinical manager on 7/12/2021 at 4:32 PM, to review the agency's Quality Assurance and Performance Improvement (QAPI) program at which time the clinical manager explained the QAPI information was not present at the agency, but rather with person Q, quality assurance nurse, at home care agency A. During an interview on 7/12/2021 at 4:32 PM, the alternate clinical manager indicated the agency and home care agency A were 2 separate agencies, but a lot of things are shared and stated, "I see things should be a little more separate." During an interview on 7/12/2021 at 4:39 PM, the alternate clinical manager indicated person Q officially worked at home care agency A and was assisting the clinical manager with QAPI and explained the QAPI binder had not yet been returned to the agency. Review of the agency's QAPI binder on 7/14/2021 at 12:18 PM, failed to evidence adverse patient events were analyzed and tracked. Review failed to evidence the agency measured, analyzed and tracked quality indicators which would improve health outcomes, patient safety and quality of care. During an interview on 7/14/2021 at 12:18 PM, when queried on what quality indicators were measured, analyzed and tracked to show measurable improvement in affecting quality of care and patient outcomes, the clinical manager indicated dyspnea (difficulty breathing) and ambulation were identified areas needing improvement for which quality indicators were tracked and measured. The clinical manager indicated the electronic health record software had a quality assurance component that compiles data for the areas the agency was deficient in. When queried where was the data to show the tracking of the improvement in the quality indicators, the clinical manager indicated the electronic health record pulls the data in real time and there was no additional documentation to show tracking of quality indicators prior to today. The clinical manager indicated the agency has not yet incorporated adverse events into the QAPI program because she just became the clinical manager in May. Review of untitled agency documents, the clinical manager provided on 7/14/2021 at 2:52 PM, evidenced a section subtitled "Performance Improvement Quality Measures". These documents stated, "Powered by: [the agency's EHR software] and indicated improvement in ambulation was 88.9% for dates of discharge from 1/1/2021 to 3/31/2021, and 73.3% from dates of discharge from 4/1/2021 to 6/30/2021. Review indicated improvement in dyspnea was 76.5% for dates of discharge from 1/1/2021 to 3/3/2021, and 72.7% from 4/1/2021 to 6/30/2021. Review failed to show measurable improvement in indicators identified by the clinical manager as needing improvement. During an interview on 7/14/2021 at 2:52 PM, the clinical manager indicated there was no improvement in the quality indicators dyspnea and ambulation because the agency was still needing to put action into place to address those areas. 17-12-2(a)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the governing body approved the frequency and detail of the data collection for quality indicator data utilized by the Quality Assessment and Performance Improvement (QAPI) program. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Aggregation of Data/Information" stated, "... Based on data collected, organizational leaders will determine which performance areas will be important to monitor, what data will be collected to determine performance, the detail of the data collected and the frequency at which the data will be collected...." Request was made on 7/12/2021 at 11:56 AM, to the clinical manager for the minutes for the governing body meetings. During an interview on 7/12/2021 at 2:27 PM, the alternate clinical manager indicated there were no governing body minutes since 3/22/2020, and stated, "I'm trying to get another set of minutes from [home care agency A]." Review of an agency document on 7/12/2021, titled "Governing Body Meeting Agenda/Minutes", dated 12/23/2019, indicated the agency goals for the year 2020 included performance improvement projects, but failed to evidence the governing body approved the frequency for the data collection. Document titled "Governing Body Meeting Agenda", 3/22/2020, failed to evidence the governing body approved the frequency and detail of the quality indicator data collection for the QAPI program. Review failed to evidence the governing body approved the data collection related to quality indicators for infections, hospitalizations and timeliness of care. Request made to the clinical manager and alternate clinical manager for any additional governing body minutes during the daily conference on 7/12/2021 at 5:06 PM, and no additional documents were provided. During an interview on 7/14/2021 at 12:18 PM, the clinical manager indicated the quality indicator data the agency collected for the QAPI program was data related to infections, hospitalizations and timeliness of care. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he is a member of the governing body and was unsure when was the last governing body meeting. When queried what was the frequency and detail of the quality indicator data for the QAPI program approved by the governing body, the administrator stated, "I don't know." The administrator indicated the clinical manager presents QAPI information at the governing body meetings, and when queried what information was presented, the administrator stated, "Whatever [the clinical manager] is working on." 17-12-2(a)

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the performance improvement activities focused on high risk, high volume or problem-prone areas. The findings include: Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Improving Organizational Performance" stated, "... Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. ... Senior management with Governing Body oversight will: ... Adopt a structured framework for performance improvement. The problem solving approach will stress the interrelationship of quality services provided ... as applicable to ... Activities related to patient care and patient safety focusing on high risk, high volume and problem prone areas and consider the incidence, prevalence, and severity...." Request made to the clinical manager on 7/12/2021 at 4:32 PM, to review the agency's Quality Assurance and Performance Improvement (QAPI) program at which time the clinical manager explained the QAPI information, to include the hospitalization log, was not present at the agency but rather with person Q, quality assurance nurse, at home care agency A. During an interview on 7/12/2021 at 4:39 PM, the alternate clinical manager indicated person Q officially worked at home care agency A and was assisting the clinical manager with QAPI and explained the QAPI binder had not yet been returned to the agency. Request was made to the clinical manager and alternate clinical manager at the daily conference on 7/13/2021 at 5:05 PM, and a request was made to the clinical manager on 7/14/2021 at 10:45 AM, for the hospitalization log. During an interview on 7/14/2021 at 12:18 PM, the clinical manager indicated the quality indicator data the agency collected included data regarding patient hospitalizations and stated, "[hospitalizations] identified due to those are higher than we'd like it to be." When queried about what actions the agency has put into place regarding the patient hospitalizations, the clinical manager stated, "The EHR [electronic health record] identifies data and we discuss at the QAPI meeting what we're going to do; we just haven't gotten to the actions yet." Review of an agency document titled "Home Health Care Insights-Population View", dated 7/14/2021, indicated 14 of 37 patients were assessed to be at a"very high" hospitalization risk. This document indicated 36% of patients had an acute care hospitalization in January 2021; no data for February 2021; 10% of patients had an acute care hospitalization in March 2021; 15% of patients had an acute care hospitalization in April 2021 and 13% had an acute care hospitalization in May 2021. Review of an agency document provided on 7/14/2021 at 5:10 PM, and identified by the clinical manager to be the agency's hospitalization log, evidenced 11 patients were hospitalized since 2/26/2021. Review indicated 3 of those patients evidenced to have had multiple hospitalizations. During an interview on 7/15/2021 at 10:12 AM, the alternate clinical manager indicated she was unsure what actions the agency had put into place regarding the patient hospitalizations and stated, "I know we've talked about it. We are aware it's high."

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the performance improvement activities considered incidence, prevalence and severity of problems. The findings include: Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Improving Organizational Performance" stated, "... Performance improvement results will be utilized to address problem issues, improve the quality of care and patient safety, and will be incorporated into program planning and process design and modifications. ... Senior management with Governing Body oversight will: ... Adopt a structured framework for performance improvement. The problem solving approach will stress the interrelationship of quality services provided ... as applicable to ... Activities related to patient care and patient safety focusing on high risk, high volume and problem prone areas and consider the incidence, prevalence, and severity...." Review of an undated agency document titled "Current Patient Census" indicated 9 of the agency's 36 active patients listed had wounds. During an interview on 7/12/2021 at 4:32 PM, the clinical manager indicated the current performance improvement plan was for wounds and stated, "Cause we have some problems with wounds." Review of the agency's Quality Assurance and Performance Improvement (QAPI) binder on 7/14/2021, evidenced an agency document titled "Focused Wound Audit Tool Quarterly Compliance Findings 2019". This document stated, "...To identify and ensure clinical compliance with patients with wounds/wound care...." Review evidenced 0% of the patients with wounds audited were compliant with wound care for the first quarter of 2019, 43% were compliant in the second quarter of 2019, 80% were compliant the third quarter of 2019 and 50% were compliant the fourth quarter of 2019. Review evidenced patients with wounds were audited for weekly wound measurements and 0% of the audits found weekly wound measurements for the first quarter of 2019, 0% in the second quarter of 2019, 40% in the third quarter of 2019 and 0% in the fourth quarter of 2019. Review evidenced the patients with wounds were reviewed for the physician notified of a change in the wound and 0% notified the physician in the first quarter of 2019, 29% notified the physician in the second quarter of 2019, 20% notified the physician in the third quarter and 16% notified the physician in the fourth quarter of 2019. The document stated, "... Improvement plan: Improve compliance with wound care protocol and orders, scoring below 90%, the agency will monitor every patient with wounds/wound care every 30 days ...." Review failed to evidence performance improvement activities regarding wounds. During an interview on 7/14/2021 at 12:18 PM, the clinical manager stated, "The EHR [electronic health record] identifies data and we discuss at the QAPI meeting what we're going to do; we just haven't gotten to the actions yet."

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the performance improvement activities tracked adverse patient events, analyzed their causes and implemented preventative actions. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Aggregation of Data/Information" stated, "... Data to be considered for collection to monitor performance of the organization include the following: ... Summaries of incidents ... Information about incidents...." Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Adverse Drug Reactions" stated, "... All adverse reactions will be reported through the incident reporting process. ... Once reported, they will be reviewed and analyzed for any significant trends, patterns, or unusual occurrences that may impact patient care. ... All adverse drug reactions will be reviewed as part of the performance improvement program...." Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 3/9/2021, and digitally signed by RN I. This document stated, "... Patient prescribed clindamycin [antibiotic] for gum infection, took approximately 6 doses with N/V [nausea and vomiting] and chest pain. Patient was seen in ER [emergency room] on 3/6/2021 with no changes in orders, clindamycin stopped and dentist calling in new prescription...." Review failed to evidence the adverse medication reaction was reported, investigated and tracked. Review of the agency's QAPI binder on 7/14/2021 at 12:18 PM, failed to evidence adverse patient events were analyzed and tracked. During an interview on 7/14/2021 at 12:18 PM, the clinical manager indicated the agency has not yet incorporated adverse events into the QAPI program because she just became the clinical manager in May. 17-12-2(a)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure they documented the quality improvement projects undertaken, the reasons for conducting these projects and the measurable progress achieved on these projects. The findings include: Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Improving Organizational Performance" stated, "... Ensure that the performance improvement projects (PIPs) are conducted that reflect the following: ... The organization must document the quality improvement projects undertaken, the reasons for conducting the projects, and the measurable progress achieved on these projects...." Review of the agency's Quality Assurance and Performance Improvement (QAPI) binder on 7/14/2021, failed to evidence performance improvement projects. During an interview on 7/14/2021 at 12:18 PM, the clinical manager stated, "The performance improvement projects were patient hospitalizations, patients with dyspnea (difficulty breathing) and patients with ambulation issues. When queried where was the documentation related to the performance improvement projects, the clinical manager indicated she would get the documentation related to the PIPs. No additional documentation was provided. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he was unsure of the performance improvement project for the agency. Request was made to the administrator for documentation related to the PIP. No additional documentation was provided by end of survey dated 07/15/2021.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency's governing body failed to ensure an ongoing program for quality improvement and patient safety was implemented and maintained and that the quality assessment and performance improvement (QAPI) efforts addressed priorities for improved quality of care and patient safety. The findings include: Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Improving Organizational Performance" stated, "... The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually...." Request was made on 7/12/2021 at 11:56 AM, to the clinical manager for the minutes of the governing body meetings. During an interview on 7/12/2021 at 2:27 PM, the alternate clinical manager indicated there were no governing body minutes since 3/22/2020, and stated, "I'm trying to get another set of minutes from [home care agency A]." Review of agency documents on 7/12/2021, titled "Governing Body Meeting Agenda/Minutes", dated 12/23/2019 and 3/22/2020, failed to evidence the governing body reviewed and evaluated the implementation of the QAPI program since 12/23/2019. Request was made to the clinical manager and alternate clinical manager for any additional governing body minutes during the daily conference on 7/12/2021 at 5:06 PM, and no additional documents were provided by end of survey dated 07/15/2021. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he was a member of the governing body and was unsure when was the last governing body meeting. When queried what was the performance improvement project for the agency, the administrator stated, "What is that?" When queried how he was involved with the QAPI program, the administrator stated, "I should be more involved." When queried what areas of improvement were needed and what actions were being taken, the administrator stated, "I let [the clinical manager] do that." The administrator indicated the clinical manager presents QAPI information at the governing body meetings, and when queried what information was presented, the administrator stated, "Whatever [the clinical manager] is working on."

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all employees practiced standard precautions and followed agency infection control policies and procedures at 1 of 1 home health visits with a licensed practical nurse. (#4) The findings include: An agency policy titled "HAND HYGIENE," revised November 2017, stated " ... When hands are not visibly dirty, contaminated with proteinaceous material, or visible soiled with blood of other body fluids, they should be washed using an alcohol-based hand rub for routinely decontaminating hands. An alternative to use of an alcohol based hand rub is to wash hands with either a non-antimicrobial or an antimicrobial soap and water ... Apply alcohol based hand rub product to the palm of one (1) hand and rub hands together, covering all surfaces of the hands and fingers (including under nails) until hands are dry ... Hand decontamination using an alcohol based hand rub should be performed: A. Before having contact with patients ... F. After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient G After removing gloves...." An agency policy titled "BAG TECHNIQUE," revised October 2011, stated "... 3. After handwashing, the supplies and/or equipment needed for the visit will be removed for the visit 4. The bag will contain a designated clean and dirty area. The clean area contains unused or clean supplies/equipment, and the dirty area contains soap, alcohol based hand cleaning supplies such as alcohol based hand cleaning supplies such as alcohol based hand rub and/or cleaning wipes and paper towels. 5. Unclean or contaminated equipment waste of any kind is not carried in the nursing bag 6. When the visit is completed, reusable equipment will be cleaned using alcohol, soap and water, or other appropriate solution, hands will be washed, and equipment and supplies will be returned to the bag. 7. Hands will be decontaminated prior to returning clean equipment to bag...." During a home visit on 7/15/2021 at 12:01 PM, LPN F was observed providing care to patient #4. LPN F sanitized her hands and donned gloves. LPN F removed her thermometer, pulse oximetry, stethoscope, blood pressure cuff and glucometer from a plastic Ziploc bag inside her nursing bag. LPN F then assessed patient #4's blood pressure, temperature, pulse, listened to lungs and heart. Patient #4's legs were assessed and a blood sugar test was performed. After getting the blood sugar reading LPN F threw away the supplies and used hand sanitizer on her gloves, failing to remove gloves and sanitize hands. LPN F then put all of her supplies back into the zip lock bag and placed them back into her nursing bag failing to sanitize the supplies prior to placing them in the bag. LPN F took off her gloves failing to sanitize her hands after the removal of her gloves and at the end of the visit. During an interview on 7/15/2021 at 4:06 PM, the alternate clinical manager stated "I prefer them to sanitize their hands after removing their gloves. I have also seen multiple pairs of gloves used and then just remove the contaminated one." When queried about sanitizing the gloves themselves the alternate clinical manager stated "I would prefer they removed the gloves and then sanitize their hands." 17-12-1(m)

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced an agency document titled "RN [registered nurse]-Skilled Visit Note", dated 6/23/21, and signed by RN L. This document stated [Patient] was given antibiotics in the hospital due to recurrent infection Review of the agency's infection control documents on 7/13/21, failed to evidence any entries for patient #1 for the year 2021. During an interview on 7/13/21 at 1:22 PM, the clinical manager indicated patient #1 was not put on the infection control log for the antibiotics. Based on observation, record review and interview, the agency failed to maintain an agency wide program for the surveillance, identification, prevention, control, and investigation of infections and communicable diseases. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Evaluating and Maintaining Records of Infections Among Patients" stated, "... All patients with a new, actual, or suspected infection will have a patient infection report completed within 24 hours of discovery. ... The Infection Identification - Patient Report form is completed when any of the following occur: A. A new, actual, or suspected infection is clinically observed by personnel ... A new antibiotic is ordered ... The Performance Improvement Coordinator summarizes, trends, and analyzes the reports. ... The Performance Improvement Coordinator, in conjunction with the Program Supervisor, will investigate possible causal factors and recommend appropriate action to contain the transmission of infection. ... Information from the summary, analysis, and discussion will be used as part of the organization's risk analysis and annual evaluation of the organization's infection prevention and control activities...." A request was made to the clinical manager and alternate clinical manager on 7/12/2021 at 4:41 PM, for the agency's infection control plan. On the desk in front of the clinical manager a binder labeled "Infection Control" was observed. During an interview on 7/12/2021 at 4:41 PM, the alternate clinical manager indicated the infection control plan could not be located. During an interview on 7/12/2021 at 4:41 PM, when queried if the binder labeled "Infection Control" observed on the desk in front of the clinical manager could be reviewed, the clinical manager indicated it was the old infection control plan and had not been updated since 2017, and refused to provide the binder for review. The clinical manager indicated the current infection control plan must be with the quality assurance and performance improvement (QAPI) program data at home care agency A. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "RN [registered nurse] - Skilled Nursing Visit", dated 3/9/2021 and digitally signed by RN I. This document stated, "... Patient prescribed clindamycin [antibiotic] for gum infection, took approximately 6 doses with N/V [nausea and vomiting] and chest pain. Patient was seen in ER [emergency room] on 3/6/2021 with no changes in orders, clindamycin stopped and dentist calling in new prescription...." Review of agency documents provided by the clinical manager on 07/12/2021 at 4:41 PM, titled "Infection Identification - Patient Report" failed to evidence documentation regarding the patient's gum infection. During an interview on 7/13/2021 at 4:36 PM, the clinical manager indicated the agency did not have an infection report for the patient's gum infection because she was unaware of the patient's infection. The clinical manager indicated an infection report should have been completed and the infection should have been investigated.

Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to provide infection control education to staff in 7 of 10 personnel records reviewed. (employees A, B, C, D, F, K, O) The findings include: Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Infection Control Plan" stated, "... Personnel will be provided training on the basics of transmission of pathogens to patients and personnel, bloodborne diseases, the use of standard precautions, infectious waste management, and other infection control procedures ... Infection control inservices will be scheduled no less than annually. Attendance will be mandatory and documented. Records of inservice attendance will be maintained in the personnel file...." Personnel record review on 7/13/2021 for the administrator, date of hire 6/9/2014, clinical manager date of hire 11/10/2014, alternate clinical manager, date of hire 5/4/2021, office coordinator D, date of hire 2/15/2021, licensed practical nurse (LPN) F, date of hire 10/22/18, contracted physical therapy assistant O, date of hire 4/6/18 and contracted occupational therapist K, date of hire 2/27/10, failed to evidence training in infection control. Review of an agency binder on 7/13/2021, titled "Inservices" evidenced agency documents titled "CHAP [Community Health Accreditation Partner] - List of Annual Inservices for field staff" which indicated infection control was included in the annual inservices. Review failed to evidence a document for RN B, RN C, LPN F, PTA O and OT K indicating receipt of infection control training. During an interview on 7/13/2021 at 12:24 PM, the alternate administrator indicated if staff was as needed (PRN) or part time, staff received their infection control training at home care agency A and not at Advanced Home Care and if staff was contracted, staff received their training from the owner of therapy agency C. The alternate administrator indicated there was no infection control training for LPN F and office coordinator D.

Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA's policies and procedures. This STANDARD is not met as evidenced by: Based on record review and interview, the skilled nurse failed to assess the patient's pain per agency policy in 3 of 8 complete clinical records reviewed. (#2, #6, #8) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Pain Assessment" stated, "... When the patient or the clinician identifies pain, the following in-depth pain assessment information should be obtained whenever possible: A. Pain intensity using a rating scale (on a scale of 0 - 10: 0 = no pain; 10 = unbearable pain). ... Pain quality, patters of radiation, and character. ... Pain onset, duration, variations, and patterns. ...Present pain management regimen and effectiveness. ... The patient's pain goal ...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "RN - Skilled Nursing Visit", dated 5/21/2021, and digitally signed by registered nurse E. This document indicated the patient had daily pain to his back, but failed to evidence a pain rating, current pain management and effectiveness and progress towards pain goal. During an interview on 7/15/2021 at 12:58 PM, the alternate clinical manager indicated there was not a pain rating assessed and a pain rating should be included. 3. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "PT [physical therapy] Visit", digitally signed by PT G and dated 7/1/2021. Review indicated the PT assessed the patient to have pain to the right knee, but failed to assess the patient's level of pain per agency policy before and after therapy. During an interview on 7/13/2021 at 3:58 PM, the clinical manager indicated therapists should assess for pain before therapy treatment. 4. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, evidenced agency documents titled "Skilled Therapy Visit Note", signed by PT N. Review indicated on document dated 4/29/2021, the patient had pain rated 4 on a scale from 0-10 and on document dated 5/1/2021, the patient's pain was rated 5 on a scale from 0-10. Review failed to evidence the PT assessed the patient's pain per agency policy to include pain management and effectiveness and the patient's pain goal. During an interview on 7/13/2021 at 3:19 PM, the clinical manager indicated pain should be completely assessed to include interventions for pain.

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on record review and interview, the licensed practical nurse (LPN) failed to provide ongoing interdisciplinary involvement of all skilled professionals involved in the patient's care in 1 of 2 clinical records reviewed receiving skilled care from a LPN. (#2) The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Continuity of Care" stated, "... The clinician will be responsible for: A. Communicating with all personnel caring for the patient including the physician ... Communicating changes in orders and findings to the Clinical Supervisor or designee, or other team members as necessary...." Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced agency documents titled "RN [registered nurse] - Skilled Nursing Visit", dated 4/28/2021, 5/12/2021 and 5/21/2021, which failed to evidence the patient had a cough. Review of document titled "LPN/LVN [licensed practical nurse/licensed vocational nurse] - Skilled Nursing Visit", dated 5/27/2021, and completed by LPN F evidenced the patient had a nonproductive cough. Review failed to evidence the LPN assessed the patient's lung sounds and failed to report the change in patient condition to the supervising RN. During an interview on 7/15/2021 at 12:59 PM, the alternate clinical manager indicated the LPN should have assessed the patient's lung sounds and notified the RN of any changes. 17-12-2(g)

Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to develop and evaluate the plan of care in 2 of 6 active clinical records reviewed. (#2, #5) 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Scope of Services" stated, "... Professional nursing services are provided in accordance with the patient's plan of care ... Initiating the plan of care and revising as necessary...." 2. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. ... At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of care based upon the patient's identified needs and will review it with the patient and family/caregiver...." 3. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient was incontinent (loss of control) of bowel and bladder, dependent for grooming, dressing, bathing, toileting and required assistance with ambulation and was at risk for falls. This document indicated the patient's goals included, but were not limited to, skin to remain intact, achieve a pain level less than 4 out of 10 and maintain ADL (activities of daily living) status. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide (HHA) services 1 time a week for 9 weeks. Review failed to evidence a plan of care was established for the patient since the certification period of 2/14/2021 - 4/14/2021. During an interview on 7/14/2021 at 3:53 PM, office coordinator D indicated she had called the office of physician L regarding the unsigned physician orders and the physician's office informed office coordinator D there was no record of the patient at the physician's office. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated RN M had been the patient's nurse case manager, but had passed away. When queried when was the last plan of care, the clinical manager indicated there was not a plan of care since the certification period of 2/14/2021 - 4/14/2021, and stated, "I discovered it the other day so that's why patient is listed 'on hold'." 4. Clinical record review on 7/14/2021 for patient #5, start of care 5/30/20, and a primary diagnosis of Type 2 diabetes [high blood sugar] with chronic kidney disease [disease affecting ability to filter waste], evidenced an agency document titled "OASIS-D1 Recertification", dated 3/31/2021, and digitally signed by RN [registered nurse] E. This document indicated the patient was incontinent [loss of control] of bowel and bladder, difficulty with ambulation, shortness of breath, needs assistance with dressing and was at risk for falls. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide services 1 time a week for 9 weeks. Review of agency documents titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 3/20/2021, 4/6/2021, 4/15/2021, 4/20/2021 and 4/27/2021, by RN M. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Review failed to evidence a plan of care was developed with the patient, for the patient, for the certification period of 3/30/2021 - 5/24/2021. 17-14-1(a)(1)(C )

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: 3. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type 2 diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had a subsection titled "Orders and Treatments," which stated, "SN [skilled nurse] 2xwk/1wk[twice a week for 1 week]: 1xwk/8wks [once a week for 8 weeks] & 2 PRN [as needed] for catheter problems PT [physical therapy] 1x1wk [once a week for one week] to begin week of 5/17/21 OT [occupational therapy]1xwk to begin the week of 5/17/21...." Clinical record review for patient #3, start of care 5/10/2021 for certification period 5/10/2021 - 7/8/2021 failed to evidence the patient was seen by occupational therapy and physical therapy. During an interview on 7/14/2021 at 9:52 AM , Person E (spouse of patient 3) indicated they are just waiting on the therapist to call so they can set up therapy appointments. During an interview on 7/14/2021 at 4:01 PM the clinical manager indicated therapy was unable to reach the patient to schedule therapy. She indicated the voicemail was full so no messages could be left for the patient. 17-14-1(a)(1)(H) Based on observation, record review and interview, skilled professionals failed to provide the services as indicated in the plan of care in 1 of 6 active clinical records reviewed. (#3) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Scope of Services" stated, "... Professional nursing services are provided in accordance with the patient's plan of care ... Rehabilitative therapies are provided according to the patient's plan of care ... Social work services are provided according to the patient's plan of care...." 2. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. ... Individualized Plan of Care: The patient-specific clinical plan of care includes: All patient care orders including verbal orders...."

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: 3. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type two diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had an area subtitled "Orders and Treatments" which stated, " ... SN [skilled nurse] to instruct the caregiver on methods to reduce friction and shear SN to instruct the caregiver on signs and symptoms of wound infection to report to the physician ... SN to instruct the caregiver on wound care ... SN to instruct the caregiver on signs and symptoms of UTI [urinary tract infection]...." Clinical review for patient #3 evidenced agency documents titled " RN [registered nurse]-Skilled Visit Notes dated 5/12/21, 5/25/21, 6/1/21, 6/8/21, 6/22/21, 6/29/21, and electronically signed by RN L. These documents failed to evidence the patient's caregiver was educated on signs and symptoms of wound infection, UTI, and reducing friction and shear. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated staff should be doing teaching every visit, but they do not teach everything at every visit. 4. Clinical record review on 7/13/2021 for patient #5, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, primary diagnosis of hypertension [high blood pressure]. This document had an area subtitled "Orders and Treatments" which stated, " ... SN to instruct the caregiver to remove clutter form the patient's path ... on the importance of adequate lighting in the patient area ... use prescribed assistive device when ambulating ... change positions slowly ... use non skid mats in tub/shower ... proper footwear when ambulating ... methods to recognize pulmonary dysfunction and relieve complications ... energy conservation ... medication side effects ... side effects of a heart attack ... signs and symptoms necessitating a call to 911 .. methods to reduce friction and shear ... float heels...." Clinical review for patient #5 evidenced agency documents titled " RN-Skilled Visit Notes dated 5/24/21, 5/27/21, 5/31/21, 6/3/21, 6/7/21, 6/22/21, 7/1/21, and electronically signed by RN E. The documents failed to evidence all of the teaching was done as ordered by the physician. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated staff should be doing teaching every visit, but they do not teach everything at every visit. 5. Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, primary diagnosis of Type 2 diabetes mellitus [high blood sugar] with foot ulcer [open sore]. This document had an area subtitled "Orders and Treatments" which stated, "SN to instruct of appropriate nail care ... to inspect feet daily ... to use moisturizer daily but avoid getting between toes ... to never work barefoot...." Clinical review for patient #1 evidenced agency documents titled " RN-Skilled Visit Notes dated 6/11/21, 6/13/21, 6/15/21, 6/23/21, 6/25/21, 6/26/21, 6/29/21, 7/2/21, 7/5/21, 7/7/21, 7/13/21, and electronically signed by RN E. These documents failed to evidence teaching was done as ordered by the physician. During a home visit on 7/13/21 at 9:31 AM, RN E was observed administering wound care to patient #1. RN E failed to do all of the teaching listed on the plan of care during the home visit. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated staff should be doing teaching every visit, but they do not teach everything at every visit. 6. Clinical record review on 7/14/21 for patient #4, start of care 5/30/21, evidenced an agency document titled "Home Health Certification and Plan of Care," signed by RN E, dated 5/24/21, and signed by physician G. Diagnoses included, but were not limited to, Type 2 diabetes mellitus [high blood sugar] with diabetic chronic kidney disease, hypertensive [high blood sugar] chronic kidney disease [ability to filter waste] chronic kidney disease stage 4, type 2 diabetes with diabetic peripheral angiopathy [disease of the blood vessels] without gangrene [tissue death] Type 2 diabetes with diabetic neuropathy [numbness or weakness], intervertebral disc displacement, lumbar region [low back pain], asthma [breathing disorder], hypothyroidism, major depressive disorder, single episode, sleep apnea [stop and start breathing while sleeping], long term use of hypoglycemic drugs, history of falling. A subsection titled "Orders and Treatments" stated "... SN to instruct on all aspects of Diabetes management to include disease process, foot assessments, signs and symptoms of hypo/hyperglycemia, glucometer use and preparation and administration of diabetic medications ordered by physician SN to instruct patient on non pharmacological pan relief including relaxation techniques, massage, stretching, positioning, and/or hot/cold pack SN to assess for skin break down every visit SN to instruct patient on methods to reduce friction and sheer SN to instruct patient to float heels...." Clinical review for patient #4 evidenced agency documents titled " RN-Skilled Visit Notes" dated 3/30/21, 4/6/21, 4/15/21, 4/20/21, 4/27/21, 5/3/21, and electronically signed by RN M. These documents failed to evidence all of the teaching was done as ordered by the physician. Clinical review for patient #4 evidenced agency documents titled " RN-Skilled Visit Notes" dated 6/10/21, 6/14/21, and electronically signed by RN E. These documents failed to evidence all of the teaching was done as ordered by the physician. Clinical review for patient #4 evidenced agency documents titled " RN-Skilled Visit Notes" dated 6/28/21, 7/8/21, and electronically signed by LPN F. These documents failed to evidence all of the teaching was done as ordered by the physician. During a home visit on 7/13/21 at 9:31 AM, LPN F was observed assessing patient #4, during the home visit LPN F failed to provide all of the teaching ordered in the plan of care. During an interview on 7/14/21 at 3:55 PM, the clinical manager indicated staff should be doing teaching every visit, but they do not teach everything at every visit. 17-14-1(a)(2)(E) Based on observation, record review and interview, the skilled nurse failed to provide patient and caregiver education in 5 of 6 active clinical records reviewed. (#1, #2, #3, #4, #5) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Patient Education Process" stated, "... Education will be the responsibility of each clinician and will focus on: ... Enhancing the patient's and family/caregiver's knowledge and ability to cope with and manage pain...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "RN - Skilled Nursing Visit", dated 5/21/2021, and digitally signed by registered nurse E. This document indicated the patient had daily pain to his back, but failed to evidence the skilled nurse provided pain management teaching to the patient/family. During an interview on 7/15/2021 at 12:58 PM, the alternate clinical manager indicated education regarding pain management should be provided to a patient assessed with pain.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the physical therapist and skilled nurse prepared clinical notes per the agency's policy in 5 of 8 clinical records reviewed. (#2, #3, #6, #7, #8) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Clinical/Service Data Collection" stated, "... Documentation in the clinical/service record will be timely, detailed, accurate, and reflect the care or services provided. ... The date and time requirement applies to all entries in the record and the medical record should accurately reflect a clear account of the patient's entire course of care. The clinical record should tell a linear story of the course of the patient's care that is managed and delivered by the organization. ... Entries into the clinical/service record will be clear, concise, and specific statements of fact. ... Entries into the clinical record will be made on the day care/service is provided to the patient. All documentation will be turned into the office at the end of the workday. ... The clinical/service note will include: ... The date the service was provided ... Signature of clinician/technician and his/her credentials ... Signature authorization of clinical/service documentation will include the staff member's name and credentials ... The information management system will be designed to assure that: ... Data is complete...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Scope of Services" stated, "... Professional nursing services are provided in accordance with the patient's plan of care ... and include ... Preparing clinical and progress notes ... Rehabilitative therapies are provided according to the patient's plan of care ... and include: ... Preparing clinical and progress notes...." 3. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document stated, "... Evaluation discussed and verbal order obtained from physician...." Review failed to evidence a verbal order was written, signed and dated by RN E and failed to evidence a plan of care for the recertification assessment completed on 6/11/2021. This document indicated the patient had a history of falls and required assistance with ambulation and failed to evidence the fall risk assessment was complete. During an interview on 7/14/2021 at 8:55 AM, when queried where was the written verbal order for the recertification on 6/11/2021, as documented, RN E indicated she did not obtain a verbal order from physician L. RN E indicated she can not get a hold of physician L, and when she calls the office of physician L, the office staff gives her the pager number for physician L but pages do not get returned. When queried why RN E documented on the OASIS recertification document the verbal order had been obtained from the physician, RN E stated, "That's just the language used to continue services at recert (recertification) but I didn't speak to the doctor." Review evidenced agency documents titled "SNV [skilled nursing visit] w/ [with] Aide Supervision", dated 6/2/2021, 7/1/2021, and digitally signed by RN E. This document evidenced a blank note for the patient's skilled observation, including but not limited to, vital signs and pain assessment. During an interview on 7/15/2021 at 1:01 PM, the alternate clinical manager indicated staff should document all care that was performed and not sign a document that was not complete. 4. Clinical record review on 7/13/2021 for patient #6, start of care 6/25/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/25/2021 - 8/23/2021, which failed to evidence a date and name, signature and credentials of the clinician who completed the plan of care. During an interview on 7/13/2021 at 3:39 PM, the clinical manager indicated the nurse case manager still needed to review the plan of care before it could be signed. Review of an agency document titled "RN - Skilled Nursing Visit", dated 7/10/2021, and digitally signed by the clinical manager, indicated the pressure wound to the right heel was 4.0 cm [centimeter] in length, 6.5 cm in width, 0.5 cm in depth with greenish drainage and a foul odor. The document indicated the physician was contacted regarding wound drainage and the patient was to make an appointment with the physician. During an interview on 7/13/2021 at 9:03 AM, nurse H at the office of physician I, indicated there was no communication in the physician's office record regarding the patient's wound and no communication with the home care agency. Nurse H indicated the physician's office was not open on 7/10/2021, and there was no message left regarding the patient's wound from the home care agency. During an interview on 7/13/2021 at 3:37 PM, the clinical manager indicated she did not call to inform the physician on 7/10/2021, regarding the wound, but rather on 7/12/2021. When queried why the physician communication was documented as completed on 7/10/2021, the clinical manager indicated it was a documentation error. Review of an agency document titled "OASIS-D1 Start of Care", dated 6/25/2021, and digitally signed by RN L, failed to be evidenced as complete and failed to evidence a complete risk assessment to include the shingles vaccination status and health screening. 5. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "OASIS-D1 Recertification", dated 2/26/2021, and digitally signed by registered nurse I. This agency document failed to be complete and failed to evidence the patient's height and weight. Review of an agency document titled "OASIS-D1 Discharge", dated 4/27/2021, and digitally signed by registered nurse I, failed to evidence the follow-up self-care assessment. 6. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, evidenced an agency document titled ""OASIS-D1 Start of Care", dated 4/12/2021 and digitally signed by registered nurse E. This document failed to evidence a complete risk assessment to include the shingles vaccination status and health screening. This document failed to evidence the clinician's credentials. Review evidenced an agency document titled ""OASIS-D1 Discharge", dated 6/10/2021, and digitally signed by registered nurse E. This document failed to evidence the clinician's credentials. Review evidenced an agency document titled "PT [physical therapy] Note", dated 6/1/2021, and completed by the physical therapist assistant (PTA). Review indicated the initials of the PTA and failed to evidence the clinician's name. During an interview on 7/13/2021 at 3:13 PM, the clinical manager indicated she was unsure which PTA completed the document and stated, "This is a PTA from [therapy agency C]." The clinical manager indicated the clinicians should complete documentation using their full name. 7. During an interview on 7/13/2021 at 3:10 PM, the clinical manager indicated clinical documents should include the clinician's signature, date and title. At 3:30 PM, the clinical manager stated, "We've told staff to complete all sections." At 4:11 PM, the clinical manager indicated the OASIS assessment should be complete. 8. Clinical record review on 7/13/2021 for patient #3, start of care 5/10/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 5/10/2021 - 7/8/2021, the diagnoses included, but were not limited to, pressure ulcer [open sore] of the left heal stage 3, fracture of right pubis, vascular dementia [memory loss from lack of blood supply to the brain] without behavioral disturbance, chronic kidney disease [disease of the organs that filter waste from the body], congestive heart failure [problem with the hearts pumping ability], type two diabetes [high blood sugar], end stage renal disease [organs not filtering waste from the body]...." This document had an area subtitled "Orders and Treatments" which stated "SN [skilled nurse] 2xwk/1wk [twice a week for one week]; 1xwk/8wks [once a week for eight weeks] & 2 PRN [as needed] for catheter problems ... SN to perform head to toe assessment ... Assessment of patient with pressure ulcer of right health stage 3, pressure ulcer of left heal stage 3 ... wound care as follows: cleanse with saline, apply silver alginate and DSD to be done every 3 days...." Clinical record review evidenced an agency document titled "RN- Skilled Nursing Visit" dated 5/12/21 and electronically signed by RN [Registered Nurse] L. This document failed to evidence wound measurements. Clinical record review evidenced an agency document titled "RN- Skilled Nursing Visit" dated 6/8/21 and electronically signed by RN L. This document failed to evidence if the wound had an odor and the stage of the pressure ulcer. Clinical record review evidenced an agency document titled "RN- Skilled Nursing Visit" dated 6/15/21 and electronically signed by RN L. This document failed to evidence if the wound had an odor and the stage of the pressure ulcer Clinical record review evidenced an agency document titled "RN- Skilled Nursing Visit" dated 6/29/21 and electronically signed by RN L. This document failed to evidence wound measurement and wound care was completed. During an interview on 7/14/2021 at 3:15 PM the clinical manager indicated there should always be wound measurements, and wounds should be assessed for drainage amount, color, and odor. 17-14-1(a)(1)(E)

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled nurse failed to communicate with the physician and other health care practitioners in 1 of 8 clinical records reviewed. (#2) The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Care Planning Process" stated, "... Clinicians will inform the patient's physician of any changes that suggest a need to alter the plan of care...." Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Adverse Drug Reactions" stated, "... All adverse drug reactions will be promptly reported to the patient's physician in order to minimize patient's health risks and discomfort...." Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Pain Assessment" stated, "... Pain assessments will be documented in the clinical record, and information will be communicated to other caregivers." Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18 and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced agency documents titled "RN - Skilled Nursing Visit", digitally signed by RN M, indicated the patient's pain was rated 5 on a scale of 0-10 on 4/21/2021 and 6 on a scale of 0-10 on 4/28/2021. Review failed to evidence the RN notified the physician of the patient's pain level. During an interview on 7/15/2021 at 12:51 PM, the alternate clinical manager indicated she would call the physician to notify of pain rated greater than 3 or 4 on a scale of 0-10. Review of an agency document titled "SNV [skilled nursing visit] w/ [with] Aide Supervision", dated 5/21/2021 and digitally signed by RN E, stated, "... patient has been stiffer and more rigid from his parkinson ...." This document indicated the patient had difficulty with ambulation, poor balance and joint pain and stiffness. Review failed to evidence the RN notified the physician of the change in stiffness and rigidity. During an interview on 7/15/2021 at 12:56 PM, the alternate clinical manager indicated the physician was not notified but should have been related to the change in stiffness and rigidity. 17-14-1(a)(1)(G)

Participate in the HHA's QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA's QAPI program; and This ELEMENT is not met as evidenced by: Based on record review and interview, all skilled professional staff failed to participate in the agency's quality assurance and performance improvement (QAPI) program. The findings include: Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Improving Organizational Performance" stated, "... All other organization personnel will: A. Be involved in performance improvement teams and activities...." Review of the agency's QAPI binder on 7/14/2021 at 12:18 PM, evidenced an agency document titled "Meeting: Quality/PI [performance improvement]", dated 6/24/2021. The document failed to evidence registered nurse (RN) C, RN E, licensed practical nurse (LPN) F, physical therapist G, occupational therapist K, PT N and physical therapist O participated in the QAPI meeting. Review failed to evidence all professional staff participated in the QAPI program. During an interview on 7/14/2021 at 8:55 PM, RN E indicated she did not participate in the QAPI program and did not know the areas identified to be in need of improvement. During an interview on 7/14/2021 at 12:18 PM, the clinical manager indicated staff participated in the QAPI program by attending inservices where QAPI was discussed. During an interview on 7/15/2021 at 12:32 PM, LPN F indicated she did not participate in the QAPI program and did not know what areas were identified to be in need of improvement.

Participate in HHA-sponsored in-service CFR(s): 484.75(b)(9) Participation in HHA-sponsored in-service training. This ELEMENT is not met as evidenced by: Based on record review and interview, all licensed professionals providing services on behalf of the agency failed to participate in agency-sponsored in-service training in 5 of 7 skilled professional personnel records reviewed. (B, C, F, K, O) The findings include: Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Scope of Services" stated, "... Professional nursing services ... include ... Participating in inservice programs ... Rehabilitative therapies are provided according to the patient's plan of care ... and include: Participating in inservice programs ... Licensed and/or certified assistants' (PTA [physical therapy assistant], COTA [certified occupational therapy assistant] duties ... will include ... Participating in inservice programs...." Personnel record review on 7/13/2021 for RN B, date of hire 11/10/2014, RN C, date of hire 5/4/2021, licensed practical nurse (LPN) F, date of hire 10/22/18, contracted physical therapy assistant O, date of hire 4/6/18 and contracted occupational therapist K, date of hire 2/27/10 failed to evidence in-service training. Review of agency documents titled "CHAP [Community Health Accreditation Partner] - List of Annual Inservices for field staff" failed to evidence RN B, RN C, LPN F, PTA O and OT K participated in agency-sponsored in-service training. During an interview on 7/13/2021 at 12:24 PM, the clinical manager indicated if staff was as needed (PRN) or part time, staff received their emergency preparedness training at home care agency A and not at Advanced Home Care and if staff was contracted, staff received their training from the owner of therapy agency C. The clinical manager indicated there was no in-service participation for for LPN F.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: 4. Clinical record review on 7/13/21 for patient #4, start of care 5/20/20, primary diagnosis of type 2 diabetes [high blood sugar] with chronic kidney disease [ability to filter waste] evidenced an agency document titled "OASIS -D1 Recertification." This document had a subsection titled ADLs/IADLs [activities of daily living/instrumental activities of daily living] which stated " ... Grooming: 1 Grooming utensils must be placed with in reach before able to complete grooming activities Ability to dress upper body ... Able to dress upper body without assistance if clothing is laid out or handed to the patient ... Ability to dress lower body ... Able to dress lower body without assistance if clothing is laid out or handed to the patient ... Bathing ... able to participate in bathing self in the shower or tub, but requires the presence of another person throughout the bath for assistance or supervision...." Clinical Record review evidenced an agency document titled "Recert [recertification] Case Conference" dated 3/31/21, and signed by RN I, which stated "Patient recertified to home health. She lives alone, uses a walker and cane for ambulation. She has Diabetes blood sugars run 130-170. She has pain to the low back 6/10, use Norco [opioid pain reliever] or Tylenol [pain relief]. Patient needs assistance getting in and out of the shower. Can wash herself with standby assist. Requesting HCA [home care aide] 1x/week for safety with showering SN 1x/week HCA 1x/week...." Clinical record review failed to evidence the skilled nurse created a home health aide care plan and assigned a home health aide to patient #4. 17-14-1(m) 17-13-2(a) Based on record review and interview, the home health agency failed to ensure the home health aides had complete, patient-specific written patient care instructions to be performed by the home health aides in 3 of 3 clinical records reviewed with home health aide services ordered. (#2, #4, #7) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Home Health Aide Plan of Care" stated, "... The patient's RN [registered nurse] Case Manager or other appropriate RN upon initialization of aide services, will develop the written home health aide plan of care, consistent with the comprehensive plan of care and physician (or other authorized licensed independent practitioner) orders. 2. The home health aide plan of care will be individualized to the specific patient and will include at least: A. Type of services/procedures to be provided, such as hands on personal care ... B. Frequency of visits ... G. Nutritional requirements H. Specific procedure to be performed, including amount, frequency, and duration ... The home health aide plan of care will be revised at least every 60 days based up a professional reassessment of the patient and at any time the patient's change of condition warrants a revision...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced an agency document titled "Aide Care Plan", dated 4/15/2021, and digitally signed by registered nurse (RN) M, which failed to evidence the frequency of home health aide visits and failed to evidence the frequency of elimination, activity and personal care tasks the home health aide was to provide. During an interview on 7/15/2021 at 1:02 PM, the alternate clinical manager indicated the frequency of the home health aide visits and the care to be provided should be included on the home health aide care plan. 3. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "OASIS-D1 Recertification", signed on 2/26/2021, and digitally signed by RN I. This comprehensive assessment indicated the patient was to receive home health aide services 2 times a week for 8 weeks and then 1 time a week for 1 week and indicated the patient was incontinent (loss of control) of bowel and bladder. Review of an agency document titled "Aide Care Plan", dated 2/26/2021, and digitally signed by RN I, failed to evidence the frequency of the home health aide services and failed to assign the home health aide to provide incontinent care. During an interview on 7/13/2021 at 4:25 PM, the clinical manager indicated the RN should have included the home health aide visit frequency on the plan of care and should have assigned the home health aide to provide incontinent care. Review of an agency document titled "RN-Skilled Nursing Visit", dated 3/16/2021, and digitally signed by RN I, indicated the patient had been hospitalized from 3/11/2021 to 3/14/2021, for a large hernia. This document stated, "... Educated on using thickened liquids as daughter states patient 'spits up' after meals...." Review failed to evidence the home health aide care plan was updated to reflect the patient's nutritional and safety need for thickened liquids. During an interview on 7/13/2021 at 4:46 PM, the clinical manager indicated the home health aide care plan should have included the thickened liquids and the nurse should have communicated the patient's need to the home health aide.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure the home health aides provided services that were ordered and included in the plan of care and consistent with the aide care plan in 3 of 3 clinical records reviewed with home health aide services ordered. (#2, #4, #7) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Home Health Aide Plan of Care" stated, "... Each patient receiving home health aide services will have an individualized plan developed by an appropriate professional and utilized to direct the care performed by the assigned aide. ... The home health aide plan of care will be individualized to the specific patient and will include at least: ... Type of services/procedures to be provided, such as hands on personal care...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced an agency document titled "Aide Care Plan", dated 4/15/2021, and digitally signed by registered nurse (RN) M, which directed the home health aide (HHA) to report a diastolic blood pressure (the pressure against the walls of the arteries when the heart is at rest and indicated by the bottom number of a blood pressure reading) of less than 56. Review of an agency document titled "HHA Visit", dated 4/29/2021, and digitally signed by HHA H, indicated the patient's diastolic blood pressure was 48. Review failed to evidence the HHA notified the supervising nurse of the blood pressure as directed in the HHA care plan. During an interview on 7/15/2021 at 1:04 PM, the alternate clinical manager indicated the HHA should have notified the RN of the blood pressure. 3. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 2/27/2021 - 4/27/2021, dated 2/26/2021, and signed by registered nurse I and the physician. This document indicated the patient was to receive home health aide services 2 times a week for 8 weeks and then 1 time a week for 1 week beginning the week of 2/28/2021. Review indicated the patient received home health aide services 3 times during week 4 beginning 3/21/2021 and 1 time during week 5 on 3/31/2021. Review failed to evidence home health aide services were provided after 3/31/2021, and failed to evidence home health aide services were provided as directed in the plan of care. During an interview on 7/13/2021 at 4:30 PM, the clinical manager indicated the last home health aide visit was on 3/31/2021, because the home health aide "fell off the face of the Earth." Review evidenced an agency document titled "Aide Care Plan", dated 2/26/2021, and digitally signed by RN I. This document indicated the home health aide was to provide oral care and perineal (the area on the body that surrounds the genitals and the anal area) care every visit and shampoo the patient weekly. Review of agency documents titled "Aide Visit Record", completed by home health aide J, evidenced the home health aide did not provide oral care and perineal care on 3/2/2021, 3/5/2021, 3/9/2021, 3/16/2021, 3/19/2021, 3/23/2021, 3/24/2021, 3/26/2021 and 3/31/2021. These documents indicated the home health shampooed the patient 2 times during the weeks of 2/28/2021 and 3/14/2021 and 3 times during the week of 3/21/2021. Review failed evidence the home health aide provided services as directed in the home health aide care plan. 4. During an interview on 7/13/2021 at 4:26 PM, the clinical manager indicated the home health aide should follow the home health aide care plan and provide all of the tasks that are assigned. 5. Clinical record review on 7/13/2021 for patient #4, start of care 5/20/21, evidenced an agency document titled "OASIS -D1 Recertification," dated 3/31/21 and electronically signed by RN [registered nurse] E This document had a subsection titled ADLs/IADLs [activities of daily living/instrumental activities of daily living] which stated " ... Grooming: 1 Grooming utensils must be be placed with in reach before able to complete grooming activities Ability to dress upper body ... Able to dress upper body without assistance if clothing is laid out or handed to the patient ... Ability to dress lower body ... Able to dress lower body without assistance if clothing is laid out or handed to the patient ... Bathing ... able to participate in bathing self in the shower or tub, but requires the presence of another person throughout the bath for assistance or supervision ... Orders for Discipline and treatments SN [skilled nurse] 1w9 [once a week for nine weeks HHA [home health aide] 1w9 [once a week for nine weeks] ... Careplan discussed with patient/caregiver and agreed upon, evaluation discussed and verbal order obtained from physician...." Clinical Record review evidenced an agency document titled "Recert [Recertification] Case Conference" dated 3/31/21, and signed by RN I, which stated "Patient recertified to home health. She lives alone, uses a walker and cane for ambulation. She has Diabetes [high blood sugar] blood sugars run 130-170. She has pain to the low back 6/10, use Norco [opioid pain reducer]or Tylenol [pain reducer]. Patient needs assistance getting in and out of the shower. Can wash herself with standby assist. Requesting HCA [home care aide] 1x/week for safety with showering SN 1x/week HCA 1x/week" Clinical Record review evidenced an agency document titled "Recert Case Conference" dated 3/31/21, and signed by office coordinator, which stated "Please get auth [authorization] for HCA for pt [patient] for new cert period ... Auth approved and added to auth screen...." Clinical record review of patient #4's electronic medical record failed to evidence patient #4 received home health care aide services.

Aides are members of interdisciplinary team CFR(s): 484.80(g)(4) Home health aides must be members of the interdisciplinary team, must report changes in the patient's condition to a registered nurse or other appropriate skilled professional, and must complete appropriate records in compliance with the HHA's policies and procedures. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health aide failed to report changes in the patient's condition to a registered nurse in 1 of 2 clinical records reviewed receiving home health aide services. (#2) The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Scope of Services" stated, "... Home health aide duties include: ... Reporting changes in the patient's condition ...." Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced an agency document titled "Aide Care Plan", dated 4/15/2021 and digitally signed by registered nurse (RN) M, which directed the home health aide (HHA) to report a diastolic blood pressure (the pressure against the walls of the arteries when the heart is at rest and indicated by the bottom number of a blood pressure reading) of less than 56. Review of an agency document titled "HHA Visit", dated 4/29/2021 and digitally signed by HHA H, indicated the patient's diastolic blood pressure was 48. Review failed to evidence the HHA notified the supervising nurse of the blood pressure as directed in the HHA care plan. During an interview on 7/15/2021 at 1:04 PM, the alternate clinical manager indicated the HHA should have notified the RN of the blood pressure. 17-14-1(m)

HH aide supervision elements CFR(s): 484.80(h)(4)(i-vi) Home health aide supervision must ensure that aides furnish care in a safe and effective manner, including, but not limited to, the following elements: (i) Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse or other appropriate skilled professional; (ii) Maintaining an open communication process with the patient, representative (if any), caregivers, and family; (iii) Demonstrating competency with assigned tasks; (iv) Complying with infection prevention and control policies and procedures; (v) Reporting changes in the patient's condition; and (vi) Honoring patient rights. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the home health aide supervision failed to ensure the home health aides followed the aide care plan in 2 of 2 clinical records reviewed receiving home health aide services. (#2, #7) The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Home Health Aide Supervisory Visits" stated, "... The registered nurse or other appropriate skilled professional that is familiar with the patient, the patient's plan of care, and the written patient care instructions must conduct supervisory visits ... Each supervisory visit shall contain documentation to ensure that the aide is furnishing care in a safe and effective manner, including, but not limited to, the following elements: 1. Following the patient's plan of care for completion of tasks assigned to a home health aide by the registered nurse ...." 2. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced an agency document titled "Aide Care Plan", dated 4/15/2021 and digitally signed by registered nurse (RN) M, which directed the home health aide (HHA) to report a diastolic blood pressure (the pressure against the walls of the arteries when the heart is at rest and indicated by the bottom number of a blood pressure reading) of less than 56. Review of an agency document titled "HHA Visit", dated 4/29/2021 and digitally signed by HHA H, indicated the patient's diastolic blood pressure was 48. Review failed to evidence the HHA notified the supervising nurse of the blood pressure as directed in the HHA care plan. Review of an agency document titled "Aide Supervisory Visit", dated 5/21/2021 and digitally signed by registered nurse E, indicated the home health aide was excellent at following the aide care plan. Review failed to evidence the registered nurse provided home health aide supervision to ensure the home health aides followed the aide care plan as directed. During an interview on 7/15/2021 at 1:08 PM, the alternate clinical manager indicated the supervising RN should have caught the aide did not follow the aide care plan. The alternate clinical manager was unsure if the RN reviewed the aide visit notes. Review indicated the last home health aide visit was provided on 6/3/2021. Review of an agency document titled "Aide Supervisory Visit", dated 6/24/2021 and digitally signed by the clinical manager, indicated the home health aide was satisfactory at reporting to duty as assigned, following the client plan of care and documents appropriately. Review failed to evidence the registered nurse provided home health aide supervision to ensure home health aide services were being provided and documented. During an interview on 7/14/2021 at 2:24 PM, HHA H indicated she had not provided home health aide services to the patient for a few weeks because she was busy providing home health aide services for home health agency A and was just a fill-in home health aide for Advanced Home Health. During an interview on 7/15/2021 at 1:09 PM, the alternate clinical manager indicated the registered nurse should have caught the home health aide was not documenting the home health aide visits. 3. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "Aide Care Plan", dated 2/26/2021, and digitally signed by RN I. This document indicated the home health aide was to provide oral care and perineal (the area on the body that surrounds the genitals and the anal area) care every visit and shampoo the patient weekly. Review of agency documents titled "Aide Visit Record", completed by home health aide J, evidenced the home health aide did not provide oral care and perineal care on 3/2/2021, 3/5/2021, 3/9/2021, 3/16/2021, 3/19/2021, 3/23/2021, 3/24/2021, 3/26/2021 and 3/31/2021. These documents indicated the home health shampooed the patient 2 times during the weeks of 2/28/2021 and 3/14/2021 and 3 times during the week of 3/21/2021. Review failed evidence the home health aide provided services as directed in the home health aide care plan. Review of an agency document titled "Aide Supervisory Visit", digitally signed by registered nurse I, indicated the home health aide was satisfactory at following the plan of care as instructed on documents dated 3/9/2021 and 4/9/2021 and excellent at following the plan of care as instructed on document dated 3/26/2021. Review failed to evidence the registered nurse provided home health aide supervision to ensure the home health aides followed the aide care plan as directed. During an interview on 7/13/2021 at 4:30 PM, the clinical manager indicated the registered nurse should have marked the home health aide supervisory note differently and followed up with the home health aide. 17-14-1(n)

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the organization and management of the home health agency as follows: failed to ensure the administrator maintained the day to day operations of the agency (see tag G0948); failed to ensure the clinical manager provided oversight of the storage of medication used to provide tuberculosis (TB; a contagious bacterial infection usually affecting the lungs) skin tests to agency personnel (see tag G0958); failed to ensure the clinical manager provided oversight in making patient and personnel assignments (see tag G0960); failed to ensure the clinical manager provided oversight for the coordination of patient care (see tag G0962); failed to ensure the clinical manager provided oversight for the coordination of referrals (see tag G0964) and failed to ensure the clinical manager provided oversight and developed, implemented and updated the individualized plan of care (see tag G0968). The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.105 Organization and Administration of Services. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to ensure the administrative and supervisory functions were not delegated to another agency or organization and the organizational structure was set forth, in writing, including lines of authority and services furnished. The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Administrative Qualifications and Responsibilities" stated, "... Authority and responsibility for administrative positions will include supervision of contracted services ... [the agency] will maintain administrative and supervisory responsibility for all care provided through contracted individuals...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Use of Organizational Chart" stated, "... There will be defined lines of authority, which clearly establishes responsibility and accountability for all organization personnel ... Organizational charts ... will be used to define relationships and lines of authority within the organization...." 3. Review of an agency document, revised November 2017 and obtained 7/15/2021, titled "Personnel Record Contents" stated, "... [Agency] will maintain current and complete personnel files on all direct and personnel and independent contractors...." 4. During an interview at the entrance conference on 7/12/2021 at 9:40 AM, the clinical manager indicated the agency provided services by the physical therapy assistant (PTA) and occupational therapy assistant (OTA). The clinical manager indicated person A was the administrator, RN B was the clinical manager and alternate administrator and RN C was the alternate clinical manager. Review of agency documents titled "Job Descriptions", revised November 2017 and obtained 7/15/2021, indicated the medical social worker (MSW), physical therapist (PT), occupational therapist (OT) and speech therapist (ST) reported to the clinical supervisor. Review on 7/12/2021, of an agency document titled "Organizational Chart", revised May 2021, indicated the MSW reported to the PT, OT and ST. Review indicated the PT, OT and ST reported to the home health aide. Review failed to evidence the lines of authority as indicated in the agency's job descriptions for the MSW, PT, OT and ST. Review failed to evidence the organizational chart included the lines of authority for the PTA and OTA. During an interview on 7/12/2021 at 9:14 AM, when queried who was the agency administrator, office coordinator D asked to whom she was talking on the phone, "Who is the administrator?" Office coordinator D indicated there was no alternate administrator and when queried who was the alternate clinical supervisor, office coordinator D stated, "Maybe [Person R name], maybe [RN C name]." During an interview on 7/14/2021 at 2:24 PM, home health aide H indicated RN C was the agency's alternate administrator. During an interview on 7/14/2021 at 4:38 PM, PT G indicated RN B was the agency's administrator and was unsure who was the clinical manager. When queried who was the alternate administrator, PT G stated, "Someone from the Illinois office." During an interview on 7/12/2021 at 11:07 AM, the administrator indicated PTA and OTA services are offered by the agency, but provided by therapy agency C. The administrator indicated therapists and the MSW reported to the clinical manager. During an interview on 7/12/2021 at 11:07 AM, the alternate clinical manager indicated she would change the organizational chart to reflect the agency's PTA and OTA services and lines of authority. 5. During an interview on 7/12/2021 at 11:44 PM, the clinical manager indicated she did not have the patient schedules for the OT visits because the receptionist for therapy agency C was working from home for the day and could not provide the OT's schedule of patient visits until tomorrow. At 12:20 PM, the clinical manager indicated she did not have the patient schedules for the PT visits for the PT visits provided by agency C. The clinical manager indicated therapy agency C scheduled the patient visits for the therapists. 6. Requested personnel record for licensed practical nurse (LPN) F, hire date 10/22/18, on 7/13/2021 at 11:40 AM, from the alternate clinical manager. During an interview on 7/13/2021 at 11:40 AM, the alternate clinical manager indicated she could not locate a personnel file for LPN F. During an interview on 7/13/2021 at 12:29 PM, the alternate clinical manager indicated she requested the personnel record for LPN F from home care agency A because LPN F works at both their agency and home care agency A. The administration failed to provide the supervision and management of the personnel file for LPN F. 17-12-1(a)(1, 2)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the administrator failed to ensure the day to day operations of the home health agency. The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Home Health Administrator" stated, "... The home health Executive Director/Administrator position will be responsible for the direction, coordination, and general supervision of all home health services. ... Responsibilities of the position will include but not be limited to: ... Planning, organizing, directing and evaluating operations to ensure the provision of adequate and appropriate care and services ... Complying with applicable law and regulations of operations ... Recruiting, employing, and retaining qualified personnel ... Directing and monitoring performance improvement activities ... Ensuring staff development including orientation, inservice education, continuing education ... Assuring the development and qualification for professional services and the assignment of personnel ... Ensuring the accuracy of public information materials ...." 2. The administrator failed to ensure the day to day operations of the home health agency as evidenced by: The administrator failed to ensure there was an Emergency Preparedness Program in place for the home health agency. Please see tags associated with federal regulation 42CFR 484.102. The administrator failed to ensure the accuracy of all reported Oasis assessment data. Please see tag G0374. The administrator failed to ensure agency patients' received all services ordered in the plan of care. Please see tag G0436. The administrator failed to ensure the comprehensive assessment medication reconciliation was reviewed by a registered nurse. Please see tag G0536. The administrator failed to ensure the home health agency was meeting all the needs of agency patients. Please see tag G0570. The administrator failed to ensure the plan of care for agency patients was followed, individualized and established by a primary care physician. Please see tag G0572. The administrator failed to ensure the plan of care contained all required elements. Please see tag G0574. The administrator failed to ensure all drugs, treatments, and services were only provided as ordered by a physician or other appropriate healthcare professional. Please see tag G0580. The administrator failed to ensure the plan of care was reviewed and revised by the primary care physician every 60 days. Please see tag G0588. The administrator failed to ensure the primary care physician was promptly alerted to changes in the patients condition. Please see tag G0590. The administrator failed to ensure there was coordination of care amongst all agency disciplines and with outside healthcare entities who serviced agency patients. Please see tag G0606. The administrator failed to ensure there was a written visit schedule in all patients homes. Please see tag G0614. The administrator failed to ensure there was a written, current medication schedule in all patients homes. Please see tag G0616. The administrator failed to ensure there was a Quality Assessment and Performance Improvement (QAPI) maintained at the home health agency. Please see tag G0640. The administrator failed to ensure the governing body maintained an ongoing QAPI program. Please see tag G0660. The administrator failed to ensure all home health agency staff followed standard precautions to ensure the prevention and transmission of infectious and communicable diseases. Please see tag G0682. The administrator failed to ensure the home health agency maintained and coordinated an agency-wide program for the surveillance, identification, prevention, control and investigation of infections and communicable diseases. Please see tag G0684. The administrator failed to ensure the home health agency had documented education on infection control provided to agency staff. Please see tag G0686. The administrator failed to ensure all home health agency skilled professionals provided services as indicated on the plan of care. Please see tag G0710. The administrator failed to ensure all home health agency staff created clinical notes and/or accurate complete notes for all services provided to patients. Please see tag G0716. The administrator failed to ensure all home health agency staff participated in the agency's QAPI program. Please see tag G0720. The administrator failed to ensure all home health aide care plans were completed by a skilled professional and included task frequencies. Please see tag G0798. The administrator failed to ensure all services provided by the home health aide were ordered by the physician, included in the plan of care, permitted to be performed under state law and consistent with the home health aides training. Please see tag G0800. The administrator failed to ensure the home health aide failed to report changes in the patient's condition to a registered nurse. Please see tag G0804. The administrator failed to ensure the supervising nurse ensured the home health aide followed the aide care plan. Please see tag G0818. The administrator failed to ensure the clinical manager provided oversight of the storage of medication used to provide tuberculosis (TB; a contagious bacterial infection usually affecting the lungs) skin tests to agency personnel. Please see tag G0958. The administrator failed to ensure the clinical manager provided oversight in making patient and personnel assignments. (See tag G0960). The administrator failed to ensure the clinical manager to provided oversight for the coordination of patient care. Please see tag G0962. The administrator failed to ensure all clinical records contained all required documentation of services rendered by agency staff. Please see tag G1012. The administrator failed to ensure all clinical record included the patient's goals and progress towards the goals in the plan of care. Please see tag G1016. The administrator failed to ensure all clinical records contained a discharge summary that was sent to the primary care physician. Please see tag G1022. 3. Personnel record review on 7/13/2021 failed to evidence an agency-specific orientation to the job for the clinical manager, alternate clinical manager, office coordinator D, home health aide H, occupational therapist K and physical therapy assistant O. Review failed to evidence the administrator provided oversight on the maintenance of the personnel records. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he did not oversee the personnel records and training, but the clinical manager provided the oversight. 4. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he was unaware of any services not provided. 17-12-1( c)(1)

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on observation, record review and interview, the clinical manager failed to provide oversight of the storage of medication used to provide tuberculosis (TB; a contagious bacterial infection usually affecting the lungs) skin tests to agency personnel. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Responsibilities/Supervision of Clinical Services" stated, "... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Policies and procedures, which guide and support the provision of care and services, are developed and implemented ... The Clinical Director will oversee the day-to-day clinical operations...." Review of an agency policy, revised November 2018 and obtained 7/15/2021, titled "Storage of Medications and Nutritional Therapies" stated, "... Medications and nutritional therapy solutions will be properly stored in the organization ... Storage of medication in the organization will be consistent with applicable law and regulation ... Medications and nutritional therapy solutions will be stored under conditions that enhance stability. Elements to be considered include: ... Appropriate storage temperatures, utilizing appropriate thermometers and temperature logs ... Multi-dose vials will be discarded 28 days after first use...." During an interview on 7/13/2021 at 10:17 AM, the clinical manager indicated the agency provides and stores the medication used to perform the skin tests for agency personnel. During an observation on 7/13/2021 at 10:19 AM, a refrigerator was observed in an area off of the agency hallway which was not labeled to be for medication storage. No refrigerator temperature log was observed on or near the refrigerator. The thermometer on the shelf of the refrigerator read 46 degrees Fahrenheit. A box labeled "Tubersol", a medication used to help detect a TB infection, was observed inside of the refrigerator with the storage temperature range included on the box to be 35-46 degrees Fahrenheit. The multi-dose vial of medication labeled "Tubersol" inside of the box was observed to be open and failed to evidence a date the vial was opened and first used. A box labeled Flucelvac Quadrivalent Influenza Vaccine (a vaccine for immunization for the prevention of the virus influenza) was observed inside the refrigerator with the storage temperature range included on the box to be 36-46 degrees Fahrenheit. Observed inside of the box were 6 pre-filled syringes labeled Flucelvac Quadrivalent Influenza Vaccine with expiration dates of 6/30/2021. During an interview on 7/13/2021 10:19 AM, the clinical manager indicated there was not a temperature log for the medication storage refrigerator and stated, "I probably check it once a week." The clinical manager stated, "The expired vaccines should be discarded." 17-12-1(d)

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight in making patient and personnel assignments. The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Responsibilities/Supervision of Clinical Services" stated, "... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Services are available ... Care and services provided by organization personnel and contracted organization personnel are coordinated and integrated ... If staffing is problematic, the Clinical Director, in coordination with the Clinical Supervisors, will review options, which include, but will not be limited to: 1. Use of outside, contracted organization personnel ... Use of office nursing personnel ... Any issue not resolved will be brought to the attention of the Executive Director/Administrator...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Patient Notification of Changes in Care" stated, "... Any significant changes will be called into the office (e.g., moving a visit from morning to afternoon)...." 3. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Continuity of Care" stated, "... The Clinical Supervisor will review the patient census and staffing levels on a daily basis and will make patient assignments which consider: ... Patient needs and skills required ... Patient acuity ... The clinician's caseload ... Patient request for personnel...." 4. During an interview on 7/12/2021 at 11:44 PM, the clinical manager indicated she did not have the patient schedules for the OT visits because the receptionist for therapy agency C was working from home for the day and could not provide the OT's schedule of patient visits until tomorrow. At 12:20 PM, the clinical manager indicated she did not have the patient schedules for the PT visits for the PT visits provided by company C. The clinical manager indicated therapy agency C scheduled the patient visits for the therapists and she did not know which therapist was assigned to go to which patients for therapy services provided by therapy agency C. During an interview on 7/13/2021 at 9:52 AM, the clinical manager indicated person N, at home care agency A, helped with the scheduling of patient visits. The clinical manager indicated person N did not have a personnel file because person N was an employee of home care agency A. 5. During an interview at the entrance conference on 7/12/2021 at 9:40 AM, the clinical manager indicated there were no patients currently requiring home health aide services. The clinical manager indicated the agency had 1 home health aide, but not currently seeing any patients. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18, evidenced an agency document titled "OASIS-D1 Recertification", dated 6/11/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient was to receive home health aide (HHA) services 1 time a week for 9 weeks. Review failed to evidence home health aide services were provided after 6/3/2021. Clinical record review on 7/14/21 for patient #4, start of care 5/30/21, evidenced an agency document titled "Recert Case Conference" dated 3/31/21 and signed by RN I. This document indicated the patient was to receive home health aide services 1 time a week. Review failed to evidence home health aide services had been scheduled for the patient. Clinical record review on 7/15/2021 for patient #10, start of care 4/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/15/2021 and digitally signed by RN L. This document indicated the patient was to receive home health aide services 1 time a week for 9 weeks. Review failed to evidence home health aide services had been scheduled for the patient. During an interview on 7/15/2021 at 10:10 AM, the alternate clinical manager indicated the agency has discharged patients due to not being able to provide home health aide services and should not accept patients needing home health aide services. The alternate clinical manager indicated the agency had advertised for home health aides and conducted interviews but had not yet found the right fit. The clinical manager indicated the agency had not offered a sign-on bonus for home health aides and the agency had not contracted home health aide services from another agency. During an interview on 7/15/2021 at 1:29 PM, the administrator indicated he was unaware of any services not provided. 17-14-1(a)(1)(K)

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight for the coordination of patient care. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Responsibilities/Supervision of Clinical Services" stated, "... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Policies and procedures, which guide and support the provision of care and services, are developed and implemented ... The Clinical Director will oversee the day-to-day clinical operations...." Review of an undated agency document on 7/12/2021, identified by the clinical manager as the active patient list, indicated patient #3, start of care 5/10/2021, received skilled nursing and physical therapy services. On 7/12/2021 at 3:54 PM, a request was made to the clinical manager for a home visit with the patient to observe physical therapy services. Office coordinator D stated, "[Patient] doesn't get PT." The clinical manager asked "When did PT stop?" Office coordinator D stated, "[Patient] never had it because it didn't' work with the wife's schedule." The clinical manager indicated she was unaware the patient was not receiving PT services.

Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight for the coordination of referrals. The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Responsibilities/Supervision of Clinical Services" stated, "... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Policies and procedures, which guide and support the provision of care and services, are developed and implemented ... The Clinical Director will oversee the day-to-day clinical operations...." 2. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Referral Disclosure and Care Decisions" stated, "... The referrals will be monitored, reviewed, and reported each month by the Program Director. ... The organization will accept only those patients ... who meet admission criteria. ... In compliance with standard medical practice, all services will be delivered under physician's (or other authorized licensed independent practitioner's) orders...." 3. Clinical record review on 7/15/2021 for patient #9, start of care 6/15/2021, evidenced an agency document titled "OASIS-D1 Start of Care", dated 6/15/2021, and digitally signed by RN L, which indicated the patient's diagnoses were Parkinson's disease and hypertension (high blood pressure). Review evidenced the patient lived alone, ate mostly frozen meals and a referral was needed to a medical social worker (MSW) for housing choices. Review indicated the patient was at risk for falls and had difficulty with ambulation, limited mobility and poor balance. The document stated, "... has frequent falls. She lives in 1 room of a house ... has to climb 4 stairs to garage to access the refrigerator and microwave...." Review indicated the agency services were to include skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review of an agency document titled "Home Health Certification and Plan of Care" for certification period 6/15/2021 - 8/13/2021, signed and dated by the nurse practitioner on 7/15/2021, indicated the orders for services included skilled nursing services 2 times a week for 2 weeks then 1 time a week for 7 weeks, PT and OT 1 time for 1 week for evaluation and MSW 1 time a month for 2 months. Review failed to evidence the patient had received any skilled nursing, PT, OT and MSW services and failed to evidence any communication regarding skilled nursing services, OT and MSW services. During an interview on 7/15/2021 at 2:22 PM, the alternate clinical manager indicated the agency was unable to reach the patient and staff should contact the clinical manager when unable to contact the patient "so it's on our radar." The alternate clinical manager indicated sometimes the agency will call the local authorities to conduct a well visit when unable to reach a patient, but it was not agency policy that it had to be done. During an interview on 7/15/2021 at 2:24 PM, office coordinator D indicated she just received an email from therapy company C regarding communication with the patient and a scheduled PT evaluation. Office coordinator indicated she had just entered the information into the clinical record regarding the message from therapy agency C. Review of an agency document titled "Patient Notes/Messages", dated 7/15/2021 and entered by office coordinator D, indicated there was a therapy services update and noted a document attachment. Review of an agency document titled "Narrative Note", dated 7/7/2021 and electronically signed by PT P, which indicated therapy company C had difficulty reaching the patient to schedule initial PT evaluation but was now scheduled for 7/15/2021. Review failed to evidence any communication regarding PT services until communication with therapy agency C on 7/15/2021. During an interview on 7/15/2021 at 2:24 PM when queried why the agency had made patient contact but the agency had not, the alternate clinical manager indicated a missed visit note in the clinical record on 6/30/2021 indicated the nurse attempted to call the patient but there was no answer. The alternate clinical manager indicated there was no communication from the agency regarding attempts to contact the patient since 6/30/2021. At 2:35 PM, the alternate clinical manager indicated office coordinator D usually sent the referrals for MSW services and indicated there was no communication regarding MSW services for the patient. The alternate clinical manager asked office coordinator D if a MSW referral was sent to agency D, office coordinator D stated, "No one has told me to contact [agency D] for a MSW referral."

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the clinical manager failed to provide oversight and develop, implement and update the individualized plan of care. The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Responsibilities/Supervision of Clinical Services" stated, "... The Clinical Director will be responsible for the clinical direction of the organization and take reasonable steps to assure that: ... Policies and procedures, which guide and support the provision of care and services, are developed and implemented ... The Clinical Director will oversee the day-to-day clinical operations...." Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. ... At the time of the initial assessment, the clinician, along with other involved disciplines, will develop the patient plan of care based upon the patient's identified needs and will review it with the patient and family/caregiver. ... The Clinical Supervisor or designee will review the plan of care for all patients...." Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Physician Participation in Plan of Care" stated, "... The attending physician will sign the plan of care/treatment within 30 days of the start of care. ... The attending physician's recertification will be obtained in intervals of at least every 60 days when the patient's plan of care is reviewed, the patient recertified, and more often, if warranted...." Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18 and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 4/21/2021 and 4/28/2021 by RN M, on 5/12/2021, 5/21/2021, 6/2/2021 and 7/1/2021 by RN E and on 5/27/2021, 6/17/2021, 6/24/2021, 6/29/2021 and 7/8/2021 by licensed practical nurse (LPN) F. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Review of agency documents titled "HHA Visit", digitally signed by HHA H, indicated the patient received HHA services to include personal care and ADL [activities of daily living] assistance on 4/15/2021, 4/22/2021, 4/29/2021, 5/6/2021, 5/13/2021, 5/20/2021, 5/27/2021 and 6/3/2021. Review failed to evidence a plan of care was developed and implemented since the plan of care for certification period of 2/14/2021 - 4/14/2021. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated RN M had been the patient's nurse case manager, but had passed away. When queried when was the last plan of care, the clinical manager indicated there was not a plan of care since the certification period of 2/14/2021 - 4/14/2021 and stated, "I discovered it the other day so that's why patient is listed on hold." Clinical record review on 7/13/2021 for patient #1, start of care 6/9/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 6/9/2021 - 8/7/2021, dated 6/9/21 and electronically signed by RN [registered nurse] L. The diagnoses included, but were not limited to, Type 2 diabetes [high blood sugar] with foot ulcer [open sore], cellulitis [skin infection] of right lower limb, corns and callosities [hard layers of skin], essential hypertension [high blood pressure]..." This document had an area subtitled "Orders and Treatments" which stated " ... "Wound Care Cleanse with betadine, pack both wounds with Iodoform gauze and cover with DSD [dry sterile dressing]. This plan of care failed to be updated with patient #1's current wound treatment During a home visit on 7/13/21 at 9:30 AM, RN E was observed changing a wound vac dressing to patient #1's right foot. Clinical record review on 7/13/21 evidenced agency documents titled RN-Skilled Nursing Visit," dated 6/25/21, 6/26/21, 6/29/21, 7/2/21, 7/5/21, 7/7/21 and signed by RN L. These documents had a subsection titled "Wounds Addressed at this Visit which stated ... Treatment Cleanse with normal saline apply black foam secure with tegaderm [transparent dressing] and attach vac at 125 mmHG [millimeters of Mercury]...." Clinical record review failed to evidence the home health agency updated the plan of care to reflect the new wound care treatment. During an interview on 7/14/21 at 3:57 PM, the clinical manager indicated there should have been an addendum to the plan of care. She was not able to locate the addendum in patient #1's clinical record. 17-14-1(a)(1)

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included all clinical notes and plans of care in 2 of 6 active clinical records reviewed. (#2, #5) The findings include: 1. Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Clinical/Service Data Collection" stated, "... Entries into the clinical/service record will be clear, concise, and specific statements of fact. ... Entries into the clinical record will be made on the day care/service is provided to the patient. All documentation will be turned into the office at the end of the workday. ... The clinical/service record ... will include at a minimum: Dates, times, and types of interventions, assessments ... Amendments, correction or late entries within an electronic health record must: ... Distinctly identify any amendment, correction or late entry...." 2. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Care Planning Process" stated, "... A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. ... Individualized Plan of Care: The patient-specific clinical plan of care includes: All patient care orders including verbal orders...." 3. Clinical record review on 7/14/2021 for patient #2, start of care 5/1/18 and a primary diagnosis of Parkinson's disease (a progressive nervous system disorder that affects movement), evidenced an agency document titled "RN - Skilled Nursing Visit", indicated skilled nursing services were provided on 4/21/2021 and 4/28/2021 by RN M, on 5/12/2021, 5/21/2021, 6/2/2021 and 7/1/2021 by RN E and on 5/27/2021, 6/17/2021, 6/24/2021, 6/29/2021 and 7/8/2021 by licensed practical nurse (LPN) F. These documents indicated the skilled nurse provided a head-to-assessment and provided patient education. Review of agency documents titled "HHA Visit", digitally signed by HHA H, indicated the patient received HHA services to include personal care and ADL [activities of daily living] assistance on 4/15/2021, 4/22/2021, 4/29/2021, 5/6/2021, 5/13/2021, 5/20/2021, 5/27/2021 and 6/3/2021. Review failed to evidence signed physician orders since the plan of care for certification period of 12/16/2020 - 2/13/2021, which was signed by the physician on 12/30/2020. Review failed to evidence a plan of care since the certification period of 2/14/2021 - 4/14/2021. During an interview on 7/14/2021 at 3:53 PM, office coordinator D indicated she had called the office of physician L regarding the unsigned physician orders and the physician's office informed office coordinator D there was no record of the patient at the physician's office. During an interview on 7/14/2021 at 3:53 PM, the clinical manager indicated RN M had been the patient's nurse case manager, but had passed away. When queried when was the last plan of care, the clinical manager indicated there was not a plan of care since the certification period of 2/14/2021 - 4/14/2021, and stated, "I discovered it the other day so that's why patient is listed 'on hold'." Review evidenced an agency document titled "HHA [home health aide] Visit", dated 6/3/2021 and digitally signed by HHA H, was the last visit note documented for home health aide services. During an interview on 7/14/2021 at 2:24 PM, HHA H indicated she had not provided home health aide services to the patient for a few weeks because she was busy providing home health aide services for home health agency A and was just a fill-in home health aide for Advanced Home Health. Review on 7/15/2021 evidenced an agency document titled "HHA Visit", dated 7/8/2021, and digitally signed by the clinical manager, which indicated the home health aide provided personal care and obtained vital signs. Review failed to evidence the document was distinctly identified as a late entry per agency policy. Review of a document titled "Task Details" provided by the alternate clinical manager on 7/15/2021 at 10:50 AM, when queried when was the HHA visit note, dated 7/8/2021, entered into the electronic health record, indicated the document was created by person N, scheduler at home health agency A, on 7/8/2021, and submitted to the electronic health record on 7/14/2021 at 10:03 PM, by HHA H. During an interview on 7/15/2021 at 10:50 AM, when queried why the home health aide visit note, dated 7/8/2021, was not in the electronic clinical record during review on 7/14/2021, the alternate clinical manager stated, "We told all the staff to get in any visits they had, so yes, it's late. We wouldn't tell them to submit documentation if they didn't do the visit." 4. Clinical record review on 7/14/2021 for patient #5, start of care 5/30/20, and a primary diagnosis of Type 2 diabetes [high blood sugar] with chronic kidney disease [disease affecting ability to filter waste], evidenced an agency document titled "OASIS-D1 Recertification", dated 3/31/2021, and digitally signed by RN [registered nurse] E. This document indicated the patient was incontinent [loss of control] of bowel and bladder, difficulty with ambulation, shortness of breath, needs assistance with dressing and was at risk for falls. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks and home health aide services 1 time a week for 9 weeks. Review of agency documents failed to evidence a plan of care for certification period 3/30/21 to 5/24//21, in the patients clinical record. During an interview on 7/15/21 at 3:40 PM, the alternate clinical manager indicated she was unable to locate the plan of care for certification period 3/30/21 to 5/24/21. 17-15-1(a)(1)-(7)

Goals in the patient's plans of care CFR(s): 484.110(a)(3) Goals in the patient's plans of care and the patient's progress toward achieving them; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the clinical record included the patient's goals and progress towards the goals in the plan of care in 1 of 2 closed clinical records reviewed. (#8) The findings include: Review of an agency policy, revised November 2017 and obtained 7/15/2021, titled "Care Planning Process" stated, "... Individualized Plan of Care: The patient-specific clinical plan of care includes: Measurable outcomes and goals identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care...." Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, and a primary diagnosis of Alzheimer's Disease (a type of dementia that affects memory, thinking and behavior), evidenced an agency document titled "OASIS-D1 Start of Care", dated 4/12/2021, and digitally signed by registered nurse (RN) E. This document indicated the patient was incontinent (loss of control) of bladder, had difficulty with ambulation, had poor balance, was dependent for grooming, dressing, bathing and toileting and was at risk for falls. Review evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 4/12/2021 - 6/10/2021, dated 4/12/2021, and digitally signed by RN E, which indicated the patient was to receive physical therapy (PT) services 1 time a week for 1 week for evaluation and skilled nursing services, 1 time a week for 9 weeks. The plan of care failed to evidence goals related to the skilled nursing and PT services the patient was to receive. During an interview on 7/13/2021 at 3:28 PM, the clinical manager indicated there were no patient-specific goals on the plan of care, but there should be.

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the transfer and discharge summary was completed and sent to the primary care physician in 1 of 2 clinical records reviewed with a transfer to a hospital (#1) and 2 of 2 closed clinical records (#7, #8) reviewed. The findings include: 1. Review of an agency policy, obtained 7/15/2021 and revised November 2017, titled "Discharge Summary" stated, "... Each patient discharged from a service and from the organization will have a written discharge summary completed and filed in the clinical record ... Each clinician who provides care will complete a discharge summary at the time of his/her discipline is discharged ... The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service ... A copy of the discharge summary will be provided to the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient's discharge..." 2. Clinical record review on 7/12/2021 for patient #7, start of care 12/29/2020, evidenced an agency document titled "OASIS-D1 Discharge", dated 4/27/2021, and digitally signed by registered nurse I. This Oasis document indicated the patient was discharged from the agency on 4/27/2021, and transferred to another home care agency per patient's request. Review failed to evidenced a discharge summary was sent to the primary care physician. During an interview on 7/13/2021 at 4:14 PM, the clinical manager indicated there was not a discharge summary sent to the physician. 3. Clinical record review on 7/13/2021 for patient #8, start of care 4/12/2021, evidenced an agency document titled "OASIS-D1 Discharge", dated 6/10/2021, and digitally signed by registered nurse E. This Oasis document indicated the patient was discharged from the agency on 6/10/2021. Review failed to evidenced a discharge summary was sent to the primary care physician. During an interview on 7/13/2021 at 3:10 PM, the clinical manager indicated there should have been a discharge summary sent to the physician but none was found in the clinical record. 4. Clinical record review on 7/13/21 for patient #1, start of care 6/9/21, evidenced discharge paperwork from Hospital K. This document indicated patient #1 was admitted to the hospital from 6/19/21 to 6/21/21, for an infected wound in the right foot. Clinical record review failed to evidence a transfer summary was completed and sent to the physician for review. During an interview on 7/13/21 at 1:32 PM, the clinical manager indicated a transfer summary was not completed or sent to the physician for patient #1's hospitalization. 17-15-1(a)(6)