Every finding on record at Cardinal Home Health Services Inc

An Emergency Preparedness survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Survey dates: February 18-21, 2025 and February 24-25, 2025 At this Emergency Preparedness survey, Cardinal Home Health Services, Inc., was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(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 a process for collaboration and cooperation with local, state, and federal emergency preparedness officials in an effort to maintain an integrated response during an emergency. The findings include: The Emergency Preparedness Plan failed to evidence any collaboration or documented communication with local, state, and federal emergency preparedness officials since the change of ownership in June 2024. On 02/25/2025, at 2:45 PM, the CM/agency owner indicated she had not collaborated with local, state, and federal emergency preparedness officials since assuming ownership last year.

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), §485.542(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 ensure the communication plan included contact information for the physicians and all services provided under arrangement. The findings include: The Emergency Preparedness Plan failed to evidence a communication plan to include contact information for the physicians and Entity 2 with whom the agency contracted therapy services. On 02/25/2025, at 2:45 PM, the CM indicated the Emergency Preparedness plan failed include contact information for the physicians and Entity 2.

EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, "Organizations" under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct exercises to test the emergency plan at least annually. The findings include: A review of the Emergency Preparedness Plan failed to evidence any testing exercise for 2024. On 02/25/2025, at 2:45 PM, the CM indicated the agency did not conduct any testing exercise in 2024.

This visit was for a Federal Recertification and State Re-Licensure survey of a home health provider. Survey Date: February 18-21, 2025 and February 24, 25, and 26, 2025 Unduplicated Skilled Admissions for the last 12 Months: 56 This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. During this Federal Complaint Survey, Cardinal Home Health Services, Inc. was found to be out of compliance with Conditions of Participation 42 CFR 484.55 Comprehensive assessment of patients and 42 CFR 484.60 Care planning, coordination of services, and quality of care. Based on the Condition-level deficiencies during the 02/26/2025 survey, your agency was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 02/24/2025. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 02/26/2025 and continuing through 02/25/2027. An Immediate Jeopardy, identified at §484.60 Care planning, coordination of services, and quality of care, began on 01/24/2025 when COTA 1 documented Patient #1 complained of pain rated at 7 out of 10 to their right heel and PT 2 documented Patient #1 had pain when bearing weight and was non weight bearing to the right foot, due to a wound. COTA 1 and PT 2 failed to coordinate care with the OT, nurse case manager, and Entity 1 related to the wound and failed to notify the physician of the complaints of pain, the wound, and to obtain treatment orders. On 01/28/2025, Entity 1 sent the home health agency authorization for skilled nursing 3 times a week for wound care and included wound care orders. The agency failed evidence they provided skilled nursing services for wound care until 02/05/2025; the documentation of the skilled nurse visits provided, failed to evidence wound care was provided per Entity 1's orders. The agency failed to revise the plan of care to include the order from Entity 1. Patient #1 had a sharps debridement of the wound, on 01/23/2025 by Entity 1, 50% percent of Patient #1’s right heel was observed with dry, thick, and yellow tissue peeling away exposing a dark red/purple area with active bleeding, and Patient #1 had complaints of increased pain to the right foot. The Administrator and Clinical Manager were notified of the Immediate Jeopardy on 02/24/2025 at 12:02 PM. An unacceptable removal plan for the Immediate Jeopardy was received on February 24, 2025 at 2:48 PM and on February 25, 2025 at 11:34 AM. The Immediate Jeopardy was unremoved at the time of exit on February 26, 2025. A revisit was conducted on 03/06/2025, and the agency conducted comprehensive assessments for 12 of 12 active patients with wounds and obtained physician orders for wound treatment. Care was coordinated with staff involved with each patient with wounds, and care plans were revised to include the wounds and current wound treatment orders. One patient, expected to readmit after a hospitalization, was originally counted in the agency’s removal plan of 13 patients with wounds; the patient could not be accepted upon hospital discharge due to a change in their insurance and was admitted to another home health agency. Due to the actions taken by the agency, the Immediate Jeopardy was removed on 03/06/2025, at 3:20 PM. Abbreviations used in report: COTA – Certified Occupational Therapy Assistant, OT – Occupational Therapist, PT – Physical Therapist, POC – Plan of Care, CM – Clinical Manager, SOC - Start of Care, HHA - Home Health Aide, RN - Registered Nurse, LPN - Licensed Practical Nurse, SN - Skilled Nurse. QR: A 1 02/26/2025

Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to electronically transmit the completed Outcome and Assessment Information Set (OASIS) assessment to the Centers for Medicare and Medicaid Services (CMS) system within 30 days of the completion of the patient assessment in 1 of 3 active clinical records reviewed with skilled services with a payor source of either Medicare or Medicaid and with an OASIS assessment completed more than 30 days. (Patient #2) The findings include: A clinical record review for Patient #2 evidenced a start of care OASIS assessment completed on 09/14/2024 which was transmitted more than 30 days after completion on 01/09/2025, a recertification OASIS assessment completed on 11/12/2024 which was transmitted more than 30 days after completion on 01/09/2025, and a recertification OASIS assessment completed on 01/09/2025 which the status indicated to be “export ready”. The clinical record failed to evidence the OASIS assessment completed on 01/09/2025 had been transmitted. On 02/24/2025, at 3:13 PM, the CM indicated the recertification OASIS assessment had not yet been transmitted and indicated she was aware the OASIS transmissions were behind schedule for some patients.

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: Based on record review and interview, the agency failed to ensure the patient was informed of and consent to care in advance of treatment and with any changes in care in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. The policy revised March 2018 titled “Consent for Treatment and Services” indicated the consent from at time of admission would be completed to include the disciplines and frequency of services to be provided. 2. A clinical record review for Patient #1 evidenced an OT POC for the initial certification period 12/24/2024-02/21/2025 which indicated the agency would provide OT services 2 times a week for 4 weeks. The Admission Consent dated 12/24/2024 indicated the agency would provide nursing and PT services and failed to evidence the frequency of visits to be provided and failed to evidence the agency was to provide OT services. On 02/21/2025, at 2:19 PM, the CM indicated the admission consent did not include OT and the frequency of services to be provided. A physician order from Entity 1 dated 01/28/2025 indicated skilled nursing was authorized 3 times a week for wound care. The clinical record failed to evidence the Patient was informed of the change in nursing frequency. On 02/21/2025, at 3:12 PM, the CM indicated there was no documentation the Patient was notified of the changes in nursing frequency. 3. A clinical record review for Patient #2 evidenced the Admission Consent dated 09/14/2024 which indicated the agency would provide skilled nursing services and failed to evidence the frequency of the visits to be provided. On 02/24/2025, at 3:12 PM, the CM indicated the frequency of services to be provided should be completed. 4. A clinical record review for Patient #3 evidenced a POC for the initial certification period 02/07/2025-04/07/2025 which indicated the agency would provide skilled nursing 1 time a week for 9 weeks, and the PT POC evidenced the agency would provide PT services 2 times a week for 5 weeks effective 02/11/2025. The clinical record failed to evidence the Admission Consent to inform the Patient of the services and frequency to be provided. On 02/24/2025, at 3:15 PM, th3 CM indicated the admission consent was not present in the clinical record. 5. A clinical record review for Patient #4 evidenced the Admission Consent dated 02/05/2024 which indicated the agency would provide skilled nursing and HHA services and failed to evidence the frequency of the services to be provided. On 02/24/2025, at 3:24 PM, the CM indicated the frequency of the services were not included on the consent form. 6. A clinical record review for Patient #5 evidenced the Admission Consent dated 01/14/2025 which indicated the agency would provide nursing, HHA, PT and OT services and failed to evidence the frequency of the services to be provided. On 02/25/2025, at 2:12 PM, the CM indicated the frequency of the services were not provided.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the home health agency failed to ensure: the initial assessment was completed within 48 hours of referral (see tag G0514); the comprehensive assessment was completed within 5 days of the SOC (see tag G0520); the comprehensive assessment included the patient’s current health status (see tag G0528); the comprehensive assessment included a review of all patient medications (see tag G0536); the comprehensive assessment included the assessment of the caregiver’s willingness, ability, and availability to provide care (see tag G0538); and the comprehensive assessment was revised after a change in condition (see tag G0544). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care for the Condition of Participation 42 CFR 484.55 Comprehensive Assessment of Patients.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to conduct an initial assessment visit within 48 hours of the referral in 1 of 3 active clinical records reviewed with a SOC since 12/01/2024. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced the Patient was referred on 12/20/2024 and the initial assessment was not until 12/24/2024. On 02/21/2025, at 2:30 PM, the CM indicated the agency had difficulty reaching the patient to schedule the initial assessment visit and did not communicate with the physician regarding the delay in the SOC.

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 5 days of the SOC in 1 of 1 active clinical record reviewed with OT services ordered at SOC since 01/01/2025. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a SOC physician order, dated 01/14/2025, which indicated OT was to evaluate and treat. The record failed to evidence the OT evaluation /assessment was completed, within 5 days of the SOC; the assessment was conducted by OT 2, dated 01/20/2025. On 02/25/2025, at 2:25 PM, the CM indicated she was unsure why the OT assessment was not completed within 5 days of the SOC.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient's status, and must include, at a minimum, the following information: (1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to complete a comprehensive assessment to include the status of the wound in 1 of 1 active clinical records reviewed with a urinary catheter (a plastic tube inserted into the bladder to drain urine). (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a skilled nursing visit note, dated 01/17/2025 and completed by the Alternate CM, indicated Patient had a foley catheter (a type of catheter that dwells in the bladder and is held in place by an inflated balloon). The recertification comprehensive assessment, completed by the Alternate CM and dated 01/28/2025, failed to evidence an assessment of the foley catheter to include the size, patency, amount and quality of the urine draining, and the size of the balloon. The comprehensive assessment indicated Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the left thigh; the documentation failed to evidence an assessment of the size of the wound. On 02/24/2025, beginning at 3:25 PM, the CM indicated wound measurements were not documented in the comprehensive assessment and indicated the comprehensive assessment did not include an assessment of the foley catheter and should include the size, balloon size, patency, and urine amount. On 02/25/2025, at 7:49 AM, the Alternate CM indicated Patient did have a foley catheter.

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 record review and interview, the agency failed to ensure the comprehensive assessment included a review of the medications to include drug interactions in 1 of 3 active clinical records reviewed with a SOC since 12/01/2024. (Patient #1) The findings include: A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 12/24/2024 which indicated the Patient had no drug interactions. A POC for an initial certification period 12/24/2024-02/21/2025 indicated the Patient’s medications included: carvedilol (to treat heart failure), albuterol (to treat shortness of breath), spironolactone (to remove excess fluid), sildenafil (for erectile dysfunction), atorvastatin (for high cholesterol), and sacubitril-valsartan (for heart failure). A review of www.drugs.com indicated 12 drug interactions to include interactions between carvedilol and albuterol, carvedilol and spironolactone, carvedilol and sildenafil, carvedilol and sacubitril-valsartan, spironolactone and albuterol, atorvastatin and sacubitril-valsartan, sacubitril-valsartan and spironolactone, and sacubitril-valsartan and albuterol. On 02/21/2025, at 3:25 PM, the Administrator indicated the program used to check for medication interactions was not working for this patient’s medication review.

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 assessment of the primary caregiver’s ability, willingness, and availability to provide care in 3 of 4 active clinical records reviewed with wounds. (Patient #1, 3, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a start of care comprehensive assessment dated 12/24/2024 which indicated the Patient needed assistance with bathing, grooming, dressing, and toileting and indicated the patient had diabetes (a chronic disease that affects the blood sugar) and was to check blood sugars. The comprehensive assessment indicated the patient lived with a caregiver and failed to include the assessment of the caregiver’s ability, willingness, and availability of personal and diabetic care. On 02/19/2025, at 1:02 PM, the Patient indicated they lived with a caregiver who worked during the day. On 02/21/2025, at 2:42 PM, the CM indicated the comprehensive assessment did not include what care the caregiver was providing. 2. A clinical record review for Patient #3 evidenced a SOC comprehensive assessment dated 02/07/2025 which indicated the Patient required assistance with activities of daily living and personal care, had diabetes and received insulin (medication for high blood sugar) injections daily, and had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the sacrum (lower back) requiring wound treatment. The comprehensive assessment indicated the Patient lived with the caregiver who provided care as needed and failed to assess the caregiver’s availability and ability to provide care to include wound care and insulin administration. On 02/20/2025, beginning at 10:47 AM, the Patient’s caregiver indicated they work and another family member comes to take care of the Patient. On 02/24/2025, at 3:16 PM, the CM indicated she was unsure what the caregiver’s availability and ability was to provide care because it was not documented in the comprehensive assessment. 3. A clinical record review for Patient #5 evidenced the SOC comprehensive assessment completed 01/14/2025 by the Alternate CM which indicated the Patient had an open wound to the left hip and indicated the nurse performed wound care by applying silver alginate and a dry dressing. The comprehensive assessment indicated the Patient lived with another person but failed to evidence the assessment of the Patient’s wound care. On 02/25/2025, at 2:21 PM, the CM indicated there was no assessment of who was providing wound care in the absence of the agency and indicated there was no assessment of the care the caregiver was willing and able to provide.

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, observation, and interview, the agency failed to ensure patients comprehensive assessment was updated, including collection of OASIS data elements, when patients' status deteriorated and developed a stage II wound, for 1 of 1 active record reviewed who received SN, PT, and OT services and was admitted without a documented wound. [Patient #1] A clinical record review for Patient #1 evidenced a SOC comprehensive assessment dated 12/24/2024 and indicated the Patient had no wounds. Visit notes completed by COTA 1 dated 01/24/2025 and 01/27/2025 evidenced the Patient complained of pain 7/10 to the right heel and had recent treatment from Entity 1 and visit note dated 01/29/2025 indicated the Patient complained of pain 6/10 to the right heel. A PT visit note completed by PT 2 dated 01/24/2025 indicated the Patient complained of pain when bearing weight and indicated the Patient was not to bear weight on the right foot due to a wound. A skilled nursing visit note completed by the Alternate CM indicated the Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the right heel. The clinical record failed to evidence a revision of the comprehensive assessment. During an observation of care at the Patient’s home on 02/19/2025, from 12:14 PM to 1:05 PM, the Alternate CM was observed performing wound care and 50% of the right heel had dry, thick, and yellow tissue peeling away exposing a dark red/purple area. Bright red drops of blood were observed dripping onto the floor. Patient #1 indicated their pain was 9/10 to the right foot and indicated they could not bear weight to the right foot due to the wound. On 02/19/2025, at 12:39 PM, the Alternate CM indicated the wound was not present at time of admission and was acquired while receiving home health services. On 02/21/2025, at 2:49 PM, the CM) indicated a new wound warranted a change in condition needing a revised comprehensive assessment and indicated there was not a revision completed.

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 observation, record review, and interview, the home health agency failed to ensure: the POC was reviewed by the physician, individualized and followed by all agency staff (See tag G0572), the POC included all required information / elements for the treatment of the patient (See tag G0574), all treatments provided by agency staff were ordered by a physician (See tag G0580), and coordination of care for all services provided to the patient (See tag G0606). 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 record review and interview, the agency failed to develop the POC in conjunction with the physician and failed to provide services as directed in the POC in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a POC for initial certification period of 12/24/2024-02/21/2025, which indicated OT and PT were to evaluate and treat. The PT POC and full evaluation completed by PT 2 on 12/27/2024 indicated the agency was to provide PT services 1 time a week for 1 week and then 2 times a week for 5 weeks; the record failed to evidence the PT reviewed the PT POC with the physician. The clinical record failed to evidence the POC was sent to the physician for review failed to evidence the agency provided PT services 2 times, as directed in the POC during the certification week of 01/26/2025. The OT POC and full evaluation, dated 01/08/2025, indicated the agency was to provide OT services 1 time a week for 1 week, 2 times a week for 4 weeks, and 1 time a week for 1 week. The clinical record failed to evidence the agency provided OT services after the OT evaluation, dated 01/08/2025, until 01/22/2025. On 02/21/2025, beginning at 2:57 PM, the CM indicated the PT should have called the physician for PT orders and indicated the PT POC was not sent to the attending physician. The CM indicated she was unsure why OT services were not provided after 01/08/2025, nor until 01/22/2025. The CM indicated there was a PT missed visit on 01/28/2025, and there were no documented attempts to reschedule the PT visit. On 02/26/2025, at 9:45 AM, PT 2 indicated he did not call the Patient’s physician to develop the POC, he indicated the agency should fax the PT POC, to the attending, for review. 2. A clinical record review for Patient #2 evidenced a POC for recertification period 11/13/2024-01/11/2025 which indicated the agency was to notify the physician of a systolic blood pressure (the pressure against the arteries when the heart is pumping and noted by the top number of a blood pressure reading) greater than 160. The recertification comprehensive assessment dated 01/09/2025 indicated the Patient’s systolic blood pressure was 193 in the right arm and 171 in the left arm and failed to evidence the agency notified the physician of the elevated blood pressure. The POC for recertification period 01/12/2025- 03/12/2025 indicated the agency would provide skilled nursing visits 1 time weekly to include review medications at every visit. The clinical record failed to evidence the agency provided skilled nursing visits during the weeks of 01/12/2025 and 02/09/2025. The skilled nurse visit notes dated 01/26/2025, 01/30/2025, and 02/06/2025 failed to evidence the skilled nurse reviewed the medications. On 02/24/2025, beginning at 3:07 PM, the CM indicated there was no documentation the agency notified the physician of the elevated blood pressure and indicated the nurse did not review the medications. The CM indicated she was unaware the skilled nursing visits were not provided for the weeks of 01/12/2025 and 02/09/2025. 3. A clinical record review for Patient #3 evidenced a POC for the initial certification period 02/07/2025-04/07/2025 which indicated the agency was to provide skilled nursing services 1 time a week for 9 weeks, and the PT POC for certification period 02/07/2025-04/07/2025 indicated the agency was to provide PT services 2 times a week for 5 weeks effective 02/11/2025. The clinical record failed to evidence any skilled nursing visits had been provided since the SOC assessment on 02/07/2025 and failed to evidence any PT visits since the PT evaluation on 02/11/2025. On 02/24/2025, at 3:23 PM, the CM indicated there were not any other nursing or PT visits documented, and she would check into it since she was not informed of any missed visits. No additional documentation or information was provided before survey exit on 02/26/2025. 4. A clinical record review for Patient #4 evidenced a POC for recertification period 01/30/2025-03/30/2025 which indicated the agency would provide skilled nursing services 2 times a week for 9 weeks. The clinical record failed to evidence the agency provided skilled nursing visits the week of 01/19/2025. On 02/24/2025, at 3:35 PM, the CM indicated there were no nursing visits documented the week of 01/19/2025 and she would check into it. No additional documentation or information was provided before survey exit on 02/26/2025. 5. A clinical record review for Patient #5 evidenced a POC for an initial certification period 01/14/2025-03/14/2025 which indicated the agency would provide nursing, HHA, PT, and OT services. An OT POC for an initial certification period of 01/14/2025-03/14/2025 indicated the agency was to provide OT services 1 time a week for 1 week, 2 times a week for 3 weeks, 1 time a week for 1 week, and 2 times a week for 3 weeks effective 1/20/2025. Week 2 beginning 01/26/2025 failed to evidence OT visits were provided and Week 4 beginning 02/09/2025 failed to evidence 2 OT visits were provided as directed in the POC. On 02/25/2025, at 2:27 PM, the CM indicated the COTA had difficulty reaching the patient and the OT visits were not provided. The CM indicated the other disciplines were able to complete their visits as directed in the POC, and the office manager eventually reached the patient to get the Patient’s input on scheduling preferences.

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 POC was developed to include all the safety precautions, interventions, and measurable goals in 5 of 5 active clinical records reviewed. (Patient #1, 2, 3, 4, 5) The findings include: 1. A clinical record review for Patient #1 evidenced a POC for the initial POC which indicated OT was to evaluate and treat, and an OT POC for the initial certification period 12/24/2024-02/21/2025 indicated the agency would provide OT services 2 times a week for 4 weeks. The home health POC failed to include interventions and goals for the OT services. The POC indicated Patient’s medications included rivaroxaban (a medication used to thin the blood to prevent/treat blood clots) and failed to evidence bleeding precautions were included in the safety measures. A SOC comprehensive assessment indicated Patient received oxygen at 2 liters per minute as needed via a nasal cannula (a plastic tube inserted into the nose), and during an observation of care at Patient’s home on 02/19/2025, beginning at 12:14 PM, the oxygen concentrator was observed. The POC failed to include oxygen precautions in the safety measures. On 02/21/2025, beginning at 2:23 PM, the CM indicated the OT interventions and goals were not in the home health POC but in the specific OT POC and indicated the oxygen and bleeding precautions were not included in the POC. 2. A clinical record review for Patient #2 evidenced a POC for recertification period 01/12/2025-03/12/2025 which included PT interventions and goals and the clinical record failed to evidence PT services were being provided. On 02/24/2025, at 3:02 PM, the CM indicated the PT interventions and goals should not be included in the POC and were a carry-over from a previous certification period when the Patient received PT services. 3. A clinical record review for Patient #3 evidenced a SOC comprehensive assessment completed by the Alternate CM on 02/07/2025 which indicated the Patient had a pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (partial thickness) to the sacrum (lower back). The comprehensive assessment indicated the Alternate CM provided wound care to the sacrum by applying medi-honey (wound ointment) and a dry dressing. The comprehensive assessment indicated the Patient had diabetes and received insulin (medication for high blood sugar) injections daily, The POC for the initial certification period 02/07/2025-04/07/2025 failed to include the wound to the sacrum, wound treatment, and interventions and goals related to the wound and diabetes management. The POC indicated the primary diagnosis for home health was malignant neoplasm of the endometrium (cancer of the uterus lining) and failed to include interventions and goals related to the primary diagnosis. On 02/25/2025, beginning at 3:22 PM, the CM indicated the POC did not include the pressure ulcer to the sacrum and the interventions and goals related to the wound, diabetes, and the primary diagnosis. 4. A clinical record review for Patient #4 evidenced skilled nurse visit notes dated 12/31/2024, 01/07/2025, 01/10/2025, 01/15/2025, and 01/17/2025 completed by the Alternate CM which indicated the Patient had a pressure ulcer stage IV (full thickness exposing bone and/or tendon) to the left thigh. The visit note dated 12/31/2024 indicated the nurse performed wound care to include applying a wound vacuum dressing (a medical device that vacuum seals to the wound to apply negative pressure and remove excess drainage) to the left thigh. Visit notes dated 01/07/2025, 01/10/2025, 01/15/2025, and 01/17/2025 indicated the nurse applied silver alginate (an absorbent, antimicrobial wound treatment) and a dry dressing to the left thigh wound. The POC for recertification period 01/30/2025-03/202/2025 failed to evidence the wound, wound treatment, and goals related to the wound. On 02/24/2025, at 3:25 PM, the CM indicated the POC did not include the wound, wound treatment order, and goals related to wounds. 5. A clinical record review for Patient #5 evidenced a POC for initial certification period 01/14/2025-03/14/2025 which indicated the agency would provide HHA services 2 times a week for 9 weeks and failed to evidence interventions and goals for the HHA services. The POC indicated the patient’s primary diagnosis was cellulitis (deep skin infection) of the back and failed to evidence interventions and goals related to the primary diagnosis. The SOC comprehensive assessment completed 01/14/2025 by the Alternate CM indicated the Patient had an open wound to the left hip and indicated the nurse performed wound care by applying silver alginate and a dry dressing. The POC failed to evidence the wound and wound treatment. On 02/25/2025, beginning at 2:13 PM, the CM indicated there were no interventions and goals related to the primary diagnosis and the HHA services. The CM indicated the wound and wound treatment order was not included in the POC.

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 ensure care was provided as directed by a physician in 2 of 4 active clinical records reviewed with a wound. (Patient #1, 3) The findings include: 1. A clinical record review for Patient #1 evidenced a physician order from Entity 1, dated and faxed to the agency on 01/28/2025, which indicated skilled nursing was ordered and authorized for wound care consisting of medi-honey (a wound ointment) and a padded dry dressing 3 times per week to the right heel pressure ulcer (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin). The agency failed to provide wound care until 2/5/2025; per the skilled nursing visit note, the SN which failed to evidence the treatment was provided as ordered. Skilled nursing visit notes dated 2/7/2025, 2/12/2025, and 2/14/2025 also failed to evidence medi-honey was applied as ordered. The agency failed to provide nursing services 3 times a week during the weeks of 2/2/2025 and 2/9/2025. On 02/21/2025, at 9:27 AM, the Alternate CM indicated she was unsure when she was notified by the Administrator of Patient #1’s wound and treatment orders. The Alternate CM indicated she did not see the wound care order until present at the patient’s house where the order and supplies were present on 02/05/2025. On 02/21/2024, at 3:04 PM, the CM indicated she was unsure why skilled nursing services were not provided 3 times a week per the order on 01/28/2025. 2. A clinical record review for Patient #3 evidenced a SOC comprehensive assessment completed by the Alternate CM on 02/07/2025 which indicated Patient had a pressure ulcer stage II (partial thickness) to the sacrum (lower back). The comprehensive assessment indicated the Alternate CM provided wound care to the sacrum by applying medi-honey and a dry dressing. The clinical record failed to evidence a physician order for wound care. On 02/24/2025, at 3:21 PM, the CM indicated there was not a wound care order in the clinical record. On 02/25/2025, at 7:49 AM, the Alternate CM indicated she knew what wound care to perform, the caregiver instructed her to what wound care was provided in the hospital, prior to admission to home health. The Alternate CM indicated there was no communication with Patient’s physician regarding wound 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 with all healthcare providers providing care in 1 of 1 clinical record reviewed with another home care company providing care (Patient #1) and in 1 of 1 clinical record reviewed with a LPN providing services (Patient #2). The findings include: 1. A clinical record review for Patient #1 evidenced a POC for the initial certification period of 12/24/2024 – 02/21/2025 which indicated the agency was to provide: SN services 1 time a month for 3 months for a full assessment, PT services 2 times a week for 5 weeks, and effective 01/08/2025 OT services 2 times a week for 4 weeks. Visit notes, completed by COTA 1 and dated 01/24/2025 and 01/27/2025, evidenced Patient complained of pain 7/10 to their right heel and had recent treatment from Entity 1. The visit note dated 01/29/2025 indicated Patient complained of pain 6/10 to their right heel. A PT visit note completed by PT 2 and dated 01/24/2025 indicated Patient complained of pain when bearing weight and indicated Patient was not to bear weight on the right foot due to a wound. The clinical record failed to evidence COTA 1 and PT 2 coordinated care with the OT, nurse case manager, and Entity 1 related to the wound. On 02/21/2025, at 9:40 AM, PT 2 indicated he was informed by the Patient of a wound on the right foot at the visit on 1/24/25, did not notify the nurse case manager regarding the wound since Patient #1 had a dressing in place to the right foot, and Patient #1 reported they received treatment at their physician’s office. On 02/21/2025, at 11:24 AM, COTA 1 indicated she did not communicate with the nurse case manager related to the wound, because she assumed nursing was providing wound care. COTA 1 could not definitely remember if she informed the occupational therapist about the wound. On 02/21/2025, at 10:25 AM, OT 2 indicated COTA 1 did not inform her of the Patient’s wound and increased pain. On 02/21/2025, at 3:04 PM, the CM indicated there was no coordination with Entity 1 and the Patient’s physician regarding the wound until 02/21/2024 when the agency requested documentation of the patient’s wound treatment. The SOC comprehensive assessment dated 12/24/2024 indicated the patient required assistance with bathing, dressing, and grooming. The clinical record failed to evidence any coordination with any other agency providing HHA services. On 02/19/2025, at 12:43 PM, Patient indicated she/he received HHA services 3 times a week on Monday, Wednesday, and Friday from another Entity. On 02/19/2025, at 12:43 PM, the Alternate CM indicated she believed Entity #1 was providing the HHA services. On 02/21/2025, at 2:54 PM, the CM indicated she was unaware the Patient was receiving HHA services and indicated there was no care coordination. 2. A clinical record review for Patient #2 evidenced a SN visit note completed by LPN 1, dated 01/26/2025, which indicated Patient reported a recurring rash and indicated the only new medication was Pepcid (to treat reflux). The record failed to evidence LPN 1 coordinated care with the RN case manager of a possible medication side effect. On 02/25/2025, at 7:49 AM, the Alternate CM/Patient’s nurse case manager indicated she was not aware of a rash due to a possible medication side effect and stated, “That’s [LPN 1’s] patient.”

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 agency failed to ensure the Governing Body approved the frequency and detail of the data collection and utilized quality indicator data from the OASIS Outcome and Assessment Information Set (OASIS) for the Quality Assessment Performance Improvement (QAPI) program. The findings include: The QAPI program and the Governing Body minutes failed to evidence the Governing Body approved the frequency and detail of the data collection. The QAPI program failed to utilize quality indicator data from the OASIS in the program’s design. On 02/25/2025, at 2:35 PM, the CM indicated there was no documented approval by the Governing Body of the frequency and detail of the data collection and indicated there was no incorporation of OASIS data in the program.

Program activities CFR(s): 484.65(c) (1) The HHA's performance improvement activities must— (i) Focus on high risk, high volume, or problem-prone areas; (ii) Consider incidence, prevalence, and severity of problems in those areas; and (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure performance improvement activities focused on high risk and problem-prone areas. The findings include: The Quality Assessment Performance Improvement (QAPI) program indicated hospitalizations increased from 5 in Quarter 3 2024 with an average patient census of 38 equaling 13% to 15 in Quarter 4 2024 with an average patient census of 52 equaling 29%. The QAPI program failed to evidence performance improvement activities related to the increased hospitalization rate. On 02/25/2025, at 2:35 PM, the CM indicated there were no performance improvement activities related to hospitalizations.

12 hours inservice every 12 months CFR(s): 484.80(d) Standard: In-service training. A home health aide must receive at least l2 hours of in-service training during each 12-month period. In-service training may occur while an aide is furnishing care to a patient. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA completed 12 hours of in-service training in a 12-month period for 3 of 3 HHA personnel records reviewed out of a total 3 HHA actively employed with the agency. (HHA 1, HHA 2, and HHA 3) The findings include: The review of the agency’s in-service documentation binder evidenced HHA 1, date of hire 09/05/2019, completed 6 hours of HHA in-services in 2024, HHA 2, date of hire 11/04/2019, completed 4 hours of HHA in-services in 2024, and HHA 3, dated of hire 09/05/2019, completed 5 hours of HHA in-services in 2024. On 02/20/2025, at 2:01 PM, the CM indicated there was no additional HHA in-services completed in 2024.

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 record review and interview, the agency failed to ensure the HHA provided services as directed in the care plan in 1 of 2 active clinical records reviewed with HHA services. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a HHA Care Plan dated 01/14/2025 which indicated the HHA was to provide oral care, incontinent care, and range of motion at every visit. HHA visit notes completed by HHA 1 dated 01/15/2025, 01/17/2025, 01/20/2025, 01/24/2025, 01/29/2025, 02/01/2025, 02/05/2025, 02/08/2025, and 02/12/2025 indicated the HHA did not provide oral care, incontinent care, and range of motion as directed in the care plan and indicated the HHA provided a shampoo and hair care which was not included in the care plan. On 02/25/2025, at 2:25 PM, the CM indicated the HHA did not follow the care plan as directed.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the HHA was supervised no less frequently than every 14 days when HHA services were provided along with skilled services in 1 of 2 active clinical records reviewed with HHA services. (Patient #4) The findings include: A clinical record review for Patient #4 evidenced a POC for recertification period 01/30/2025-03/30/2025 which indicated the agency would provide skilled nursing and HHA services both 2 times a week for 9 weeks. The clinical record evidenced skilled nursing services were provided on 01/31/2025, 02/04/2025, and 02/07/2025 and HHA services were provided 02/01/2025, 02/03/2025, 02/08/2025, 02/09/2025, 02/15/2025, and 02/16/2025. The record failed to evidence supervision of the HHA since 01/28/2025. On 02/24/2025, at 3:34 PM, the CM indicated there was no other documented HHA supervision since 01/28/2025.

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 record review and interview, the agency failed to ensure the HHA supervision included the HHA followed the aide care plan in 1 of 2 active clinical records reviewed with HHA services. (Patient #5) The findings include: A clinical record review for Patient #5 evidenced a HHA Care Plan dated 01/14/2025 which indicated the HHA was to provide oral care, incontinent care, and range of motion at every visit. HHA visit notes completed by HHA 1 dated 01/15/2025, 01/17/2025, 01/20/2025, and 01/24/2025 indicated the HHA did not provide oral care, incontinent care, and range of motion as directed in the care plan and indicated the HHA provided a shampoo and hair care which was not included in the care plan. The HHA supervision visit dated 01/28/2025 and signed by the Alternate CM indicated the HHA provided services per the care plan and failed to evidence the RN provided supervision to ensure the HHA followed the aide care plan as directed. On 02/26/2025, at 11:53 AM, the Alternate CM indicated she was not aware HHA 1 did not provide services as directed in the care plan and indicated she did not review the HHA visit notes.

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 provide to the physician the discharge summary within 5 business days of discharge from the agency in 2 of 2 closed records reviewed. (Patient #6, 7) The findings include: 1. A clinical record review for Patient #6 evidenced a discharge summary dated 01/08/2025 which indicated the agency discharged the Patient on 12/31/2024 and failed to evidence the agency sent the discharge summary to the physician. 2. A clinical record review for Patient #7 evidenced a discharge summary dated 12/30/2024 which indicated the agency discharged the Patient on 12/26/2024 and failed to evidence the agency sent the discharge summary to the physician. 3. On 02/25/2025, beginning at 2:31 PM, the CM indicated there was no documentation the discharge summary was sent to the physician for either Patient #6 or Patient #7.

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 staff documented timely, into the clinical record, in 3 of 5 active clinical records reviewed. (Patient #1, 4, and 5) The findings include: 1. A policy revised February 2021 titled “Timely Submission of Patient Documentation” indicated visit reports should be submitted the next scheduled work day and was not to exceed 3 days. 2. A clinical record review for Patient #1 evidenced a PT Evaluation/Assessment completed by PT 2 and dated 12/27/2024; the clinical record failed to evidence PT 2 documented and submitted the assessment in the electronic health record [EHR] until 01/12/2025. The PT Discharge, dated 1/31/2025, was not completed and submitted by PT 2 until 02/09/2025. The OT Discharge was scheduled in the electronic health record for 02/11/2025; the status was “not yet started.” On 02/21/2025, beginning at 2:56 PM, the CM indicated the PT documentation should have been completed within 5 days. The CM indicated the OT had not yet started the documentation of Patients' OT discharge. 3. A clinical record review for Patient #4 evidenced a POC for recertification period 01/30/2025 -03/30/2025 which indicated the agency would provide skilled nursing [SN] services 2 times a week for 9 weeks. The EHR evidenced SN visits were scheduled; and the status of the SN visit documentation for the dates 02/11/2025, 02/14/2025, 02/18/2025, and 02/21/2025 was “not yet completed." On 02/24/2025, at 3:34 PM, the CM indicated the SN visits were completed, not yet documented. 4. A clinical record review for Patient #5 evidenced the agency provided skilled nursing and HHA services, and the last HHA supervisory visit in the electronic health record was completed on 01/28/2025. The EHR indicated SN visits were scheduled on 02/04/2025, 02/14/2025, 02/16/2025, 02/18/2025, 02/21/2025; the status of these visits was “not yet started” and failed to evidence any documentation for the visits. On 02/25/2025, at 2:28 PM, the CM indicated the Alternate CM completed a HHA supervision visit on 02/11/2025 and had not yet documented. The CM indicated the Alternate CM completed visits every Friday and the CM completed visits every Tuesday and had not yet documented the visits.

An Emergency Preparedness survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Facility ID: 006655 Survey dates: 2/14/2022-2/21/2022 At this Emergency Preparedness survey, Cardinal Home Health Services, 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 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] 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: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[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 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); 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); 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); to ensure a policy included a system for medical documentation that preserves patient information, protects patient confidentiality, and secures and maintains availability of records in the event of an emergency (see tag E0023); to ensure a policy included the use of volunteers or other emergency staffing in the event of an emergency (see tag E0024); to develop and maintain an emergency preparedness communication plan which included names and contact information for staff, patients' physicians, volunteers and other agencies (E0030); 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, 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); and to conduct exercises to test the emergency plan annually (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.

Local, State, Tribal Collaboration Process CFR(s): 484.102(a)(4) §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(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' efforts to maintain an integrated response during a disaster or emergency preparedness. The findings include: Review on 2/16/2022, of an undated agency document titled "Emergency Preparedness Plan" stated, "... Cardinal Home Health Emergency plan is to provide mitigation, preparation, response and recovery to disasters or emergencies affecting the environment of care, and to ensure continuation of care, and to ensure continuation of care and/or services to the patient population being served….” Review 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 2/16/2022, at 1:48 PM, the administrator indicated he went to district emergency preparedness planning meetings in the past. The administrator indicted the emergency preparedness plan does not include a process for the collaboration and cooperation with local, regional, State, and Federal emergency preparedness officials.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(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 the patients which provided appropriate instructions, in the event of an emergency in 4 of 5 active clinical records reviewed. (#1, #2, #3, #4) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Emergency Operations Plan and Policies” revised January 2020, stated, “… Mitigation activities … will be undertaken in an effort to lesson the severity and impact of a potential emergency. Such activities include: … Developing an individual emergency preparedness plan for each patient as part of the comprehensive assessment….” 2. Clinical record review on 2/18/2022, for patient #1, start of care 9/4/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022. This document indicated the patient’s safety precautions included oxygen precautions and indicated the patient used oxygen as needed. This document indicated the patient had a wound to the left great toe, to which the skilled nurse was to provide wound care twice a week. Review of an agency document titled “Patient Individualized Emergency Plan”, signed and dated by registered nurse (RN) D on 9/4/2020, failed to evidence the patient’s oxygen and wound care supplies. This document failed to provide patient instructions for a safe space in the patient’s home, a safe meeting place in the patient’s neighborhood, and a safe meeting place outside of the neighborhood in the event of an emergency. During an interview on 2/18/2022 at 11:56 AM, the alternate administrator indicated the individualized emergency plan should include oxygen and wound care supplies and indicated the form should be completed. 3. Clinical record review on 2/17/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022. This document evidenced the patient’s diagnoses included, but were not limited to, pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the left and right buttocks, gastrostomy (a tube surgically inserted into the stomach through the abdomen used to administer nutrition, fluid, and/or medication), and diabetes (a chronic condition which affects the way the body processes blood sugar). This document indicated the skilled nurse was to clean the wounds with normal saline (a solution used to clean wounds) and apply barrier ointment. Review of this document indicated the patient had a foley catheter (an indwelling plastic tube inserted into the bladder to drain urine). Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, dated and electronically signed by RN D on 1/7/2022, indicated the patient was NPO (nothing by mouth) and received tube feedings four times a day through his gastrostomy. Review of an undated agency document titled “Patient Individualized Emergency Plan”, signed by RN D, failed to evidence the patient’s wound care, tube feeding, and foley catheter needs. During an interview on 1/21/2022, at 1:14 PM, the alternate administrator indicated the wound care, tube feeding, and foley catheter was not included in the individualized emergency preparedness plan and indicated it should have been. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, electronically signed by RN F and dated 1/8/2022. Review of the comprehensive assessment indicated the patient had a pressure ulcer stage III (an open pressure ulcer with full thickness loss of skin) the left buttock, a pressure ulcer stage III to the right buttock, and a pressure ulcer stage III to the left heel. Review of an undated agency document titled “Patient Individualized Emergency Plan”, signed by RN F, indicated the patient had a wound to the left heel and failed to evidence the patient’s wounds to the left buttock and the right buttock. During an interview on 2/21/2022, at 2:06 PM, the alternate administrator indicated all the patient’s wounds should be included on the individualized emergency plan. 5. Clinical record review on 2/17/2022, for patient #4, start of care 2/2/2022, evidenced an agency document titled “OASIS-D1 Start of Care” with a visit date of 2/2/2022. This document indicated the patient was assessed to have poor balance, a shuffling and unsteady gait, limited range of motion to both lower extremities, muscle weakness, a history of falls, and at risk for falls. This document indicated the patient required human assistance for activities and used a wheelchair and walker. Review of an undated agency document titled “Patient Individualized Emergency Plan”, signed and dated by the alternate administrator on 2/2/2022, failed to evidence the patient’s restricted mobility to include the assistance required with ambulation. During an interview on 2/18/2022, at 3:58 PM, the alternate administrator indicated the individualized emergency plan should indicate the patient’s required use of a wheelchair or walker.

HHA- Procedures for Follow up Staff/Pts. CFR(s): 484.102(b)(3) §484.102(b)(3) Condition of Participation: [(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 ensure a policy included the agency must inform state and local officials of on-duty staff and patients that are unable to be reached in the event of an emergency. The findings include: Review on 2/16/2022, of an undated agency document titled "Emergency Preparedness Plan" stated, "... Cardinal Home Health Emergency plan is to provide mitigation, preparation, response and recovery to disasters or emergencies affecting the environment of care, and to ensure continuation of care, and to ensure continuation of care and/or services to the patient population being served….” Review of the agency's emergency preparedness binder failed to evidence a policy that included the agency must inform state and local officials of on-duty staff and patients that are unable to be reached. During an interview on 2/16/2022, at 1:48 PM, the administrator stated, “It is not a feasible option for us to go rescue everyone.” The administrator indicated the policy needs to be clearer.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(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 facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure a policy included a system for medical documentation that preserves patient information, protects patient confidentiality, and secures and maintains availability of records in the event of an emergency. The findings include: Review on 2/16/2022, of an undated agency document titled "Emergency Preparedness Plan" stated, "... Cardinal Home Health Emergency plan is to provide mitigation, preparation, response and recovery to disasters or emergencies affecting the environment of care, and to ensure continuation of care, and to ensure continuation of care and/or services to the patient population being served….” Review of the agency's emergency preparedness binder failed to evidence a policy that included a system for medical documentation that preserves patient information, protects patient confidentiality, and secures and maintains availability of records in the event of an emergency. During an interview on 2/16/2022, at 1:48 PM, the administrator indicated the agency used an electronic health record. The administrator stated, “If we were hacked, it would be catastrophic.” The administrator indicated the policy did not include the system for medical documentation in the event of an emergency.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(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 facilities]. 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 a policy included the use of volunteers or other emergency staffing in the event of an emergency. The findings include: Review on 2/16/2022, of an undated agency document titled "Emergency Preparedness Plan" stated, "... Cardinal Home Health Emergency plan is to provide mitigation, preparation, response and recovery to disasters or emergencies affecting the environment of care, and to ensure continuation of care, and to ensure continuation of care and/or services to the patient population being served….” Review of the agency's emergency preparedness binder failed to evidence a policy that included the use of volunteers or other emergency staffing the event of an emergency. During an interview on 2/16/2022, at 1:48 PM, the administrator indicated the agency has not included the use of volunteers in their emergency preparedness plan. When queried what the agency would do if an emergency left few or no staff available, the administrator indicated the agency would group patients with the available staff and indicated he has not included that in the emergency preparedness policy.

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 ensure the communication plan included names and contact information for staff in the event of an emergency. The findings include: Review of an untitled agency policy on 2/16/2022, titled “Emergency Management Policy” stated, “… A listing of all staff members and telephone numbers will be included in the agency’s on-call book….” Review on 2/16/2022, of the emergency preparedness binder evidenced an agency document titled "Employee Phone List” dated 12/27/2021. This document failed to evidence the names and contact information for home health aide (HHA) N and HHA S were included. During an interview on 2/16/2022, at 1:48 PM, the alternate administrator indicated the employee phone tree was outdated.

Methods for Sharing Information CFR(s): 484.102(c)(4)-(5) §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(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 facilities]. 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 ensure the communication plan included a method for sharing information and medical documentation for patients under the agency’s care with other health care providers to maintain continuity of care, and in the event of an evacuation, a means of releasing patient information and providing general information about the general condition and location of patients under the agency’s care. The findings include: Review on 2/16/2022, of the emergency preparedness binder evidenced an undated agency document titled “Emergency Preparedness Plan”. This document stated, “… If the patient is unharmed but the home is damaged or unsafe and the telephone system is working, contact family or friends that the patient may request and make arrangements for the patient’s transportation….” Review of a document titled "Patients” dated 12/27/2021, failed to evidence the names and patient information for patient #3, start of care 1/8/2022, patient #4, start of care 2/2/2022, and patient #5, start of care 2/2/2022. During an interview on 2/16/2022, at 1:48 PM, the administrator indicated the patient roster is outdated and should be updated as patients come and go.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and 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 PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization 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 PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE 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 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 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 PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE'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 HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a 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 every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA 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 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 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 HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA'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. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to conduct exercises to test the emergency preparedness plan at least annually. The findings include: Review on 2/16/2022, of the emergency preparedness binder failed evidenced an undated agency document titled “Addendum 7-001 (9/20/17) as approved by the Governing Body” which stated, “… The organization will document the table top exercise during emergency or actual Response to emergencies. On a yearly basis, the table top exercise with the participation of the organization’s leaders and staff will be conducted….” Review failed to evidence the agency conducted an exercise to test the emergency preparedness plan since 11/30/2020. During an interview on 2/16/2022, at 1:48 PM, the administrator indicated the last table top exercise was performed on 11/30/2020.

This visit was for a Federal Recertification and State Re-licensure survey. Facility ID: 006655 Survey Dates: 2/14/2022 - 2/21/2022 Cardinal Home Health Services, Inc. is precluded from providing its own home health aide training and competency evaluation for a period of two years from 02/21/2022 – 02/21/2024, 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, 484.70 Infection Prevention and Control, 484.75 Skilled Professional Services, and 484.80 Home Health Aide Services. Quality Review Completed 03/11/2022 An IDR was conducted on 5/24/22 in which G584 was modified.

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 observation, record review, and interview, the agency failed to ensure the OASIS (Outcome and Assessment Information Set, a comprehensive assessment data collection tool) accurately reflected the patient’s status in 2 of 5 active clinical records reviewed. (#3, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Reporting of OASIS Information” revised February 2021, stated, “… Agency staff will ensure that the accuracy of OASIS data reflects the patient’s status at time of assessment and data collection….” 2. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, electronically signed and dated by registered nurse (RN) F on 1/8/2022. This document indicated the patient’s activity was up as tolerated with a walker and the patient had a shuffling gait. This document indicated at the OASIS question M1860, the patient was chairfast and unable to ambulate. During an observation of care at the patient’s home on 2/21/2022, at 1:17 PM, physical therapist (PT) G assisted the patient with ambulation using the walker. During an interview on 2/21/2022, at 1:19 PM, the alternate administrator indicated the OASIS was incorrectly marked by the RN and indicated the patient was not chairfast. 3. Clinical record review on 2/17/2022, for patient #5, start of care 2/2/2022, evidenced an unsigned agency document titled “OASIS-D1 Start of Care”, with a visit date of 2/2/2022. This document indicated the OASIS question M0080, which indicated which discipline completed the assessment, was not completed. This document indicated the OASIS question M1845, which provided the assessment of the patient’s ability to provide toilet hygiene, was not completed. During an interview on 2/18/2022, at 4:00 PM, the alternate administrator indicated the answer to the question M0080 was the RN was the discipline that completed the assessment. At 4:08 PM, the alternate administrator indicated the patient probably needed help to complete toilet hygiene.

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 to receive complaints in 3 of 3 home visits conducted. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Compliance with Laws and Regulations and Disclosure of Information” revised March 2018, stated, “… The Agency and its staff will furnish services in compliance with all applicable federal, state and local laws and regulations ….” 2. Review of an untitled, undated agency document on 2/14/2021, within a folder identified by the alternate administrator as the patient admission folder, stated, “… If you need assistance, have questions, or have a complaint about our agency, staff or services, please contact us at: … [Alternate Administrator] Administrator ….” 3. During an interview at the entrance conference on 2/14/2022, at 10:14 AM, the alternate administrator indicated she was the alternate administrator and employee A was the administrator. 4. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 10:18 AM, an agency folder was not observed in the home. The name and contact information for the administrator was not observed to have been provided to the patient. 5. During an observation of care at the home of patient #2, start of care 7/16/2021, on 2/16/2022, at 11:25 AM, the agency home folder was observed in the patient’s bedroom. Inside of the agency folder, an undated, untitled agency document was observed, which stated, “… “… If you need assistance, have questions, or have a complaint about our agency, staff or services, please contact us at: … [Alternate Administrator] Administrator ….” The name of the administrator was not observed to have been provided to the patient. 6. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/18/2022, at 1:08 PM, the agency home folder was observed in the patient’s home. Inside of the agency folder, an undated, untitled agency document was observed, which stated, “… “… If you need assistance, have questions, or have a complaint about our agency, staff or services, please contact us at: … [Alternate Administrator] Administrator ….” The name of the administrator was not observed to have been provided to the patient. 7. During an interview on 2/15/2022, at 9:48 AM, when queried why the alternate administrator was listed as the administrator on the untitled document in the patient admission folder, the alternate administrator stated, “Oh, I need to change that.”

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: Based on record review and interview, the agency failed to ensure the patient was informed of and consented to care in advance of the frequency of visits and changes in the care to be furnished in 2 of 7 clinical records reviewed. (#1, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Patient Bill of Rights and Responsibilities” stated, “… Patients have the right: … Participate in, be informed about and consent or refuse care in advance of and during treatment … with respect to: … The frequency of visits … Any changes in the care to be furnished….” 2. Clinical record review on 2/16/2022, for patient #1, start of care, 9/4/2020, evidenced an agency document titled “Admission Consent”, signed by the patient and dated 9/4/2020. This document indicated the patient was informed of and consented to receiving home health aide services 3 times a week for 3 weeks and then 2 times a week for 6 weeks. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022, signed by the physician on 1/23/2022. This document indicated the patient was to receive home health aide services 3 times a week for 8 weeks. Review failed to evidence the patient was informed of in advance of the changes in the home health aide frequency. During an interview on 2/18/2022, at 11:57 AM, the alternate administrator indicated patients should be notified of changes. The alternate administrator indicated she would check for when the patient was informed of the change in the home health aide frequency. No further documentation was provided. 3. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Admission Consent”, signed and dated by the patient on 11/20/2021. This document indicated the patient would receive skilled nursing services. Review of an agency document titled “PT [physical therapy] Evaluation”, electronically signed by PT L and dated 12/8/2021, evidenced the patient would receive PT services 2 times a week for 4 weeks. Review failed to evidence the patient was informed of the change in services to include the physical therapy evaluation in advance of the change in services. During an interview on 2/18/2022, at 11:25 AM, the alternate administrator indicated she did not see documentation the patient was notified in advance of the PT evaluation. The alternate administrator indicated we need to document our verbal communication to the patient. 17-12-3(b)(2)(D)(ii)(BB)

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was discharged because the physician responsible for the plan of care and the agency agreed the measurable goals and outcomes set forth in the plan of care had been achieved in 1 of 1 closed clinical record reviewed with a discharge reason of goals met. (#6) The findings include: Review of an agency policy obtained 2/15/2022, titled “Discharge Criteria and Planning” revised February 2021, stated, “… Patient will be discharged from services as follows: … The discharge is appropriate because the physician/practitioner who is responsible for the home health plan of care and the Agency agree that measurable outcomes and goals set forth in the plan of care have been achieved and the Agency and the physician/practitioner responsible for the home health plan of care agree that the patient no longer needs the Agency’s services….” Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the patient was to receive skilled nursing services 1 time a week for 8 weeks beginning the week of 11/28/2021 and home health aide services 2 times a week for 9 weeks. This document indicated the patient’s goals included, but were not limited to, have a tolerable level of pain rated 0-2 on a scale of 0-10, have absence of edema (swelling), and would not have signs and symptoms of complications related to hemorrhoids. Review evidenced the discharge plan was to discharge when the patient demonstrated necessary skills to self-manage disease process and when the patient’s pain level stabilized. Review evidenced agency documents titled “SN [skilled nurse] Teaching/Training Visit”, electronically signed by registered nurse (RN) D. Review of documents dated 12/2/2021, 12/9/2021, 12/23/2021, 12/30/2021, 1/3/2022, and 1/20/2022, indicated the patient had daily pain to the knees rated 5 on a scale of 0-10. These documents indicated the patient had rectal bleeding from hemorrhoids and indicated the patient had 1+ pitting edema to the legs. Review evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Discharge”, electronically signed by RN D and dated 1/19/2022. This document indicated the patient had generalized pain the time rated 3 on a scale of 0-10. Review indicated the patient had edema to the lower extremities and had hemorrhoids with rectal bleeding. Review indicated the reason for discharge was the patient’s goals were met. Review failed to evidence the patient met goals. During an interview on 2/18/2022, at 11:02 AM, the alternate administrator indicated the patient did not meet goals and indicated the physician was not made aware of the patient had not met goals prior to discharge.

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient was discharged because the patient refused services in 1 of 1 closed clinical record reviewed with a discharge reason of patient requested discharge. (#7) The findings include: Review of an agency policy obtained 2/15/2022, titled “Discharge Criteria and Planning” revised February 2021, stated, “… Patient will be discharged from services as follows: … Patient refuses services or elects to be discharged. … A patient who occasionally declines a service is distinguished from a patient who refuses services altogether, or who habitually declines skilled care visits. It is the patient’s right to refuse services. It is the Agency’s responsibility to educate the patient to the risks and potential adverse outcomes that can result from refusing services. In the case of patient refusals of skilled care, the Agency must document its communication with the physician/practitioner who is responsible for the patient’s home health plan of care, as well as the measures the Agency took to investigate the patient’s refusal and the interventions the Agency attempted in order to obtain patient participation with the plan of care….” Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/19/2021 – 1/17/2022, which was signed by the physician on 12/16/2021. This document indicated skilled nursing services were to be provided 1 time a week for 9 weeks. Review evidenced an agency document titled “PT [physical therapy] Plan of Care”, electronically signed and dated by PT L on 12/8/2021. This document indicated the PT would provide services 2 times a week for 4 weeks. Review of agency documents titled “Missed Visit”, electronically signed and dated by registered nurse (RN) F on 12/21/2021, 12/28/2021, and 1/4/2022, indicated the patient refused the visit. Review failed to evidence the patient was offered to reschedule the missed visits. Review evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Discharge”, electronically signed by the alternate administrator and dated 1/13/2022. This document indicated the patient was discharged from the agency on 1/13/2022 per patient request. Review failed to evidence documentation of communication with the patient/caregiver regarding the patient’s request to discharge. Review failed to evidence the agency educated the patient to the risks and potential adverse outcomes that can result from refusing services per the agency’s policy. Review failed to evidence the agency documented the measures the agency took to investigate the patient’s refusal and the interventions the agency attempted to obtain patient participation with the plan of care per the agency’s policy. During an interview on 2/14/2022, at 5:10 PM, the patient’s caregiver indicated the patient did not request to be discharged from the agency and indicated the patient was still receiving services from the agency. The patient’s caregiver indicated the agency informed him the patient needed to be recertified but was not informed that the agency had discharged the patient. During an interview on 2/18/2022, at 11:22 AM, the alternate administrator indicated the patient was discharged because the patient had refused skilled nursing visits. The administrator indicated there was no documentation of communication with the physician regarding the potential discharge from the agency due to missed visits. The alternate administrator indicated there was no documentation of education provided by the agency to the potential risks of refusing skilled visits and interventions taken by the agency to ensure the patient participated with the plan of care.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure a registered nurse (RN) conducted the initial assessment to determine the immediate care and support needs of the patient in 1 of 1 partial clinical record reviewed. (#8) The findings include: Review of an agency policy obtained 2/21/2022, titled “Initial Assessments/Comprehensive Assessments” revised February 2021, stated, “… The initial assessment visit is conducted to determine the immediate care and support needs of the patient. … RN must complete the comprehensive assessment … when skilled nursing is ordered. … The Initial Comprehensive Assessment also includes: … Physical assessment/review of systems and pertinent physical findings….” During an interview on 2/16/2022, at 4:02 PM, person C, nurse consultant, indicated the alternate administrator contacted her inquiring if 3 new patients should be added to the survey’s active patient roster. Person C indicated the alternate administrator explained the initial comprehensive assessments were completed by a licensed practical nurse (LPN) and not a RN. Clinical record review on 2/18/2022, for patient #8, start of care 2/10/2022, evidenced an unsigned agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Start of Care” with a visit date of 2/10/2022. This document failed to evidence who the clinician was that completed the assessment. This document indicated the patient had no wounds. Review of an unsigned agency document titled “SN [skilled nurse] Wound Care Visit” with a visit date of 2/15/2022, which indicated the patient had a pressure ulcer (wound to the skin and underlying tissue resulting from prolonged pressure to the skin) stage III (an open pressure ulcer with full thickness loss of skin) to the right gluteal cleft (the crease at the bottom of the spine where the buttocks split) and a pressure ulcer stage III to the left gluteal cleft. The document indicated the onset date for both wounds was 10/21/2019. During an interview on 2/18/2022, at 9:00 AM, the alternate administrator indicated she completed the initial assessment on 2/10/2022 and indicated the patient would not allow the alternate administrator to assess the wounds on the patient’s buttocks. The alternate administrator indicated she was aware the patient had wounds to his buttocks because the patient had a prior admission with the agency before transferring to the hospital on 1/19/2022. The alternate administrator indicated LPN J completed the wound assessment when LPN J went on a visit on 2/10/2022 because LPN J was more familiar with the patient and his wounds from his prior admission. The alternate administrator indicated LPN J conducted the visit on 2/15/2022 and indicated there was not a visit note from LPN J for 2/10/2022. 17-14-1(a)(1)(A)

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 record review and interview, the agency failed to ensure the comprehensive assessment reflected the patient’s current health status in 3 of 5 active clinical records reviewed. (#2, #3, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Initial Assessments/Comprehensive Assessments” revised February 2021, stated, “… The Agency’s comprehensive assessment includes the use of the Outcome and Assessment Information Set (OASIS) items for all patients … The Initial Comprehensive Assessment also includes: … Physical assessment/review of systems and pertinent physical findings….” 2. Review of an agency policy obtained 2/21/2022, titled “Reassessments/Update of the Comprehensive Assessment” revised February 2021, stated, “… Minimally, the comprehensive assessment must be updated and revised: … Recertification ….” 3. Clinical record review on 2/17/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, signed and dated by registered nurse (RN) D on 1/7/2022. This document indicated the patient had two pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin), one on the left buttock and one on the right buttock. Review evidenced a subsection titled “Potential Risk for Infection Assessment”, which failed to evidence the patient’s wounds were checked to be included in the risk of infection assessment. This document indicated the wounds to the right and left buttocks were stage II (an open pressure ulcer with partial thickness loss of skin) and failed to evidence the assessment included the depth of the wounds. Clinical record review on 2/17/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022. This document indicated the patient was NPO (nothing by mouth) and had a gastrostomy (a tube surgically inserted into the stomach through the abdomen used to deliver nutrition, fluids, and/or medication). This document failed to evidence aspiration (when food, fluid or another substance enters the airway or lungs accidentally, may occur when there is difficulty with swallowing) precautions were noted. During an interview on 2/18/2022, at 12:10 PM, the alternate administrator indicated the wounds should have been included in the risk of infection assessment. At 12:17 PM, the alternate administrator indicated aspiration precautions should have been included in the comprehensive assessment due to the patient’s NPO status. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, electronically signed by RN F and dated 1/8/2022. Review of the comprehensive assessment indicated the patient’s diagnoses included, but were not limited to, malignant neoplasm (abnormal mass of tissue) of the prostate and bone and indicated the skilled nurse was to educate on the signs and symptoms of potential complications of the malignant neoplasm to the bone and prostate. The comprehensive assessment indicated the patient had abnormal bowel sounds and failed to evidence what about the bowel sounds were abnormal. During an interview at the patient’s home on 2/18/2022, at 1:17 PM, the patient’s caregiver indicated the patient had a port in his chest from when he received chemotherapy. The patient’s caregiver indicated the port had been in his chest for over a year but was no longer accessed. The patient’s caregiver indicated she was unsure if the port was to be flushed. Review failed to evidence the port in the patient’s chest was included in the comprehensive assessment. During an interview on 2/21/2022, at 1:15 PM, the alternate administrator indicated the abnormal bowel sounds should have been assessed to include what was abnormal on the assessment. At 2:05 PM, the alternate clinical manager indicated the port should have been included on the comprehensive assessment. 5. Clinical record review on 7/20/2020, for patient #5, start of care 2/2/2022, evidenced an agency document titled “OASIS-D1 Discharge”, electronically signed by the alternate administrator and dated 11/8/2021. This document failed to evidence the comprehensive assessment included an assessment of the gastrointestinal (GI) system (the digestive system). During an interview on 2/18/2022, at 3:59 PM, the alternate administrator indicated the comprehensive assessment should include the assessment of the GI system. 6. During an interview on 2/18/2022, at 12:12 PM, the alternate administrator indicated the assessment of wounds should include length and width and should include depth if the wound is open. 17-14-1(a)(1)(B)

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 agency failed to ensure the patient’s medication was reviewed to identify any potential adverse effects and drug reactions in 7 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7) The findings include: 1. Review of an agency policy obtained on 2/18/2022, titled “Initial Assessments/Comprehensive Assessment” revised February 2021, stated, “… Each patient’s comprehensive assessment includes a review of all medications the patient is currently taking … The Agency nurse must consider and document each medication that the patient is taking to identify: Significant side effects. Significant drug interactions. Noncompliance with medication. Duplicate drug therapy. Potential adverse effects….” 2. Review of an agency policy obtained on 2/18/2022, titled “Medications Reconciliation” revised February 2021, stated, “… At time of admission, the admitting RN [registered nurse] … will create and document a complete list of medications that patient is taking at home … Any concerns or discrepancies will be reconciled by a RN with the patient’s physician/practitioner. Discrepancies include duplications, omissions, changes, contraindications and/or unclear information … Medications ordered while the patient is receiving care will be compared to the medication list/profile. The medication list/profile will be updated with each new or changed medication….” 3. During an observation of care on 2/16/2022, at 9:59 AM, at the home of patient #1, start of care 9/4/2020, the patient’s medications were observed in a box under the coffee table in the living room. Leucovorin (a medication used to treat or prevent serious blood cell disorders caused by certain medications) and Centrum (a multivitamin) were observed in the box of medications. Home Health Aide C was observed applying lotion from a bottle labeled “Ammonium Lactate” (a topical medication used to treat dry, scaly skin conditions) to the patient’s legs. Clinical record review on 2/16/2022, evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review failed to evidence Leucovorin, Centrum, and Ammonium Lactate were reviewed to identify potential side effects. During an interview on 2/18/2022, at 12:02 PM, the alternate administrator indicated the medication profile was last signed and dated in the electronic medical record by person A on 2/5/2022. 4. During an observation of care on 2/16/2022, at 11:48 AM, for patient #2, start of care 7/16/2021, the patient’s medications were observed in a bag provided by the patient’s daughter. Atorvastatin (a medication used to treat high cholesterol) and Donepezil (a medication used to treat Alzheimer’s Disease, a disease affecting memory loss and cognitive abilities) were observed in prescription bottles in the bag. Amlodipine (a medication used to treat high blood pressure) was observed with a label that indicated the patient was to take 5 milligrams (mg) daily. A bottle labeled “Prednisolone” (a medication used to treat inflammation and allergies of the eye) was observed on the patient’s dresser. The patient’s daughter indicated the bottle was eye drop medication for the patient’s eyes. Clinical record review on 2/16/2022, evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review failed to evidence Atorvastatin, Donepezil, and Prenisolone. This document indicated the patient was to take Amlodipine 10 mg daily. During an interview on 2/18/2022, at 12:02 PM, the alternate administrator indicated the medication profile was last signed and dated in the electronic medical record by person A on 2/5/2022. 5. During an observation of care on 2/18/2022, at 1:17 PM, for patient #3, start of care 1/8/2022, the patient’s medications were observed in a box provided by the patient’s caregiver. Metalozone (a medication that reduces the amount of water in the body to treat fluid retention and high blood pressure), Vitamin D3 (vitamin supplement), and Dulcolax (a medication used to treat constipation) were observed in the patient’s box of medications. During an interview at the patient’s home on 2/18/2022, at 1:17 PM, the patient’s caregiver indicated the patient was administered Basaglar (a type of insulin, an injectable medication used to treat high blood sugar) 24 units in the morning and 50 units in the evening. Patient’s caregiver indicated the patient no longer takes Linzess (a medication used to treat chronic constipation and irritable bowel syndrome). Clinical record review on 2/21/2022, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit”, electronically signed by licensed practical nurse (LPN) H and dated 1/25/2022. This document indicated the LPN assessed the patient’s pain to be rated 2 on a scale of 0-10. This document indicated the patient’s pain was relieved by medication. Review evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review failed to evidence Metalozone, Vitamin D3, and Dulcolax. This document indicated the patient was to take Linzess daily and Basaglar 15 units in the morning and 45 units in the evening. This document failed to evidence a medication for pain was reviewed. During an interview on 2/21/2022, at 1:15 PM, the alternate administrator indicated the medication profile was last signed and dated in the electronic medical record by person A on 2/5/2022. At 1:33 PM, the alternate administrator indicated she was unsure what pain medication the patient was taking and indicated the medication should have been included on the medication profile and reviewed for potential adverse effects. 6. Clinical record review on 2/21/2022, for patient #4, start of care 2/2/2022, evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review failed to evidence the patient’s medication had been reviewed for potential side effects. During an interview on 2/21/2022, at 12:20 PM, the alternate administrator indicated the medication profile was signed by person A on 2/19/2022. 7. Clinical record review on 2/21/2022, for patient #5, start of care 2/2/2022, evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review failed to evidence the patient’s medication had been reviewed for potential side effects. During an interview on 2/21/2022, at 12:20 PM, the alternate administrator indicated the medication profile was signed by person A on 2/19/2022. 8. Clinical record on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review failed to evidence the patient’s medication had been reviewed for potential side effects. During an interview on 2/21/2022, at 12:20 PM, the alternate administrator indicated the medication profile was signed by person A on 1/6/2022. 9. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Medication Profile”. This document failed to be signed and dated by a clinician. Review of agency documents titled “SN Teaching/Training Visit”, electronically signed by RN F and dated 11/23/2021, 12/2/2021, 12/7/2021, and 12/14/2021, indicated the patient used laxatives (medication used for the treatment of constipation) and/or enemas (a treatment to treat constipation by injecting a solution into the colon through the rectum). Review failed to evidence the medication profile included a laxative or enema had been reviewed for potential adverse effects. During an interview on 2/18/2022, at 11:16 AM, the alternate administrator indicated there was not a laxative or enema that had been reviewed for potential adverse effects. During an interview on 2/21/2022, at 12:20 PM, the alternate administrator indicated the medication profile was signed by person A on 1/22/2022. 10. During an interview at the entrance conference on 2/14/2022, at 10:14 AM, the alternate administrator indicated the medication review is completed when the medication is entered on to the medication profile in the electronic medical record. The alternate administrator indicated the drug interactions are checked when the RN clicks the drug interaction button on the medication profile in the electronic medical record. The alternate administrator indicated if the medication is not entered in the medication profile, the medication has not been reviewed for drug interactions. 11. During an interview on 2/18/2022, at 11:24 PM, when queried why the printed copies of the medication profile were not signed or dated, the alternate administrator indicated the document should be signed and dated by the clinician who reviewed the medications. The alternate administrator indicated person A, a registered nurse from a company that performs the agency’s quality assurance, signed and dated the medication profiles and indicated she was unsure why the medication profiles were not signed when printed. The alternate administrator indicated person A was not a direct employee, did not provide direct patient care, and did not conduct the medication reconciliation with the patient. The alternate administrator indicated person A used the list of medications obtained by the nurse who completed the comprehensive assessment in the home. 17-14-1(a)(1)(B)

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 new wounds in 1 of 3 active clinical records reviewed with wounds. (#2) The findings include: Review of an agency policy obtained 2/21/2022, titled “Reassessments/Update of the Comprehensive Assessment” revised February 2021, stated, “… The comprehensive assessment (including OASIS [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] data elements) must be updated and revised as frequently as the patient’s condition warrants due to a major improvement or decline in health status … Each patient will be reassessed when: A significant change in condition, status, diagnosis, care, environment or support system occurs. A marked improvement of worsening of a patient’s condition, which changes, and was not anticipated in, the patient’s plan of care would be considered a “major decline or improvement in the patient’s health status” that would warrant an update and revision of the comprehensive assessment….” Clinical record review on 2/17/2022 and 2/21/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “OASIS-D1 Recertification”, signed and dated by registered nurse (RN) D on 1/7/2022. This document indicated the patient had 2 pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (an open pressure ulcer with partial thickness loss of skin), 1 located on the left buttock and 1 located on the right buttock. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, which was signed by the physician on 2/4/2022, indicated the patient had a pressure ulcer to the left buttock and a pressure ulcer to the right buttock. The document indicated the skilled nurse was to clean the wounds with normal saline (a solution used to clean wounds) and apply barrier ointment. Review of an agency document titled “SN [skilled nurse] Wound Care Visit”, dated and electronically signed by RN D on 2/9/2022, evidenced two new pressure ulcers Stage II to the left lateral buttock. Review of an agency document titled “Physician Order”, electronically signed and dated by the alternate administrator on 2/9/2022, evidenced the 2 wounds to the left lateral buttocks were to be cleaned with normal saline, apply anasept gel (an antimicrobial wound gel) to the wound bed, apply calcium alginate (a highly absorptive wound dressing), and cover with mepilex (a foam dressing) 2 times a week. Review failed to evidence the comprehensive assessment was updated and revised to reflect the 2 wounds to the left lateral buttock. During an interview on 2/18/2022, at 12:39 PM, the alternate administrator indicated a new wound is a significant change and indicated the comprehensive assessment was not updated and revised. 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: 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); 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); revisions to the plans for patient discharge were communicated to the physician responsible for the plan of care (See tag G0598); coordination of care for all services provided to the patient (See tag G0606); the written visit schedule was provided to patients (See tag G0614); written instructions were provided to the patient for the patient's medication schedule and instructions (See tag G0616); the treatments to be administered by agency personnel were provided to the patient and caregiver in writing (See tag G0618); and the name and contact information of the clinical manager were provided in writing to the patient and caregiver (See tag G0622). 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 agency failed to ensure the patient’s medical and social needs were met in 3 of 7 clinical records reviewed. (#4. #5, #6) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” revised February 2021, stated, “… Patients are accepted for treatment on the reasonable expectation that Agency can meet the patient’s medical, nursing, rehabilitative and social needs ….” 2. Review of an agency policy obtained 2/21/2022, titled “Care Planning Process” revised February 2021, stated, “… In order to assure that care provided is appropriately planned to meet each patient’s specific needs and problems, the Agency will utilize data/information gathered during patient assessments in the care planning process….” 3. Clinical record review on 2/17/2022, for patient #4, start of care 2/2/2022, evidenced an unsigned agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Start of Care” with a visit date of 2/2/2022. This document indicated the patient had poor balance, a shuffling and unsteady gait, limited range of motion to both lower extremities, muscle weakness, a history of falls, and at risk for falls. Review failed to evidence the agency offered the patient physical therapy (PT) services and failed to evidence the agency met the patient’s need for physical therapy services based on the comprehensive assessment. During an interview on 2/18/2022, at 3:47 PM, when queried why the patient was not offered physical therapy services based on the initial comprehensive assessment, the alternate administrator indicated the patient was accepting of physical therapy services. The alternate administrator stated, “We had a little tightness in [physical therapist I] schedule.” The alternate administrator indicated the agency could have had another PT complete the evaluation. 4. Clinical record review on 2/17/2022, for patient #5, start of care 2/2/2022, evidenced an unsigned agency document titled “OASIS-D1 Start of Care” with a visit date of 2/2/2022. This document indicated the patient had an unsteady gait, poor balance, had limited range of motion to both lower extremities, required the use of a walker for ambulation, had a history of falls, was at a risk of falls, and had limited endurance. Review failed to evidence the agency offered the patient physical therapy services and failed to evidence the agency met the patient’s need for physical therapy services based on the comprehensive assessment. During an interview on 2/18/2022, at 4:07 PM, the alternate administrator indicated she had received a verbal order from the patient’s physician for physical therapy services and indicated she had not yet written the verbal order. The alternate administrator indicated the agency was waiting for the return of PT I to complete the PT evaluation and indicated the agency had not met the patient’s need for PT services. 5. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “OASIS-D1 Recertification”, electronically signed and dated by RN D on 11/22/2021. This document indicated the patient’s primary diagnosis was heart disease with heart failure and used oxygen at 2 liters per minute as needed. This document indicated the patient lived alone with no available caregivers. Review indicated the patient had urinary incontinence (loss of bladder control), had poor balance, had an unsteady gait, had limited range of motion, was at risk for falls, and needed assistance with activities of daily living (ADL). Review failed to evidence the agency evaluated the patient’s need for and provided social work services. During an interview on 2/16/2022, at 11:55 AM, RN D indicated the patient lives alone, was unable to walk, weighs over 300 pounds, and uses a wheelchair. RN D stated, “She has COPD [chronic obstructive pulmonary disease, a lung disease causing difficulty breathing) and heart disease real bad.” RN D indicated the patient needs assistance. During an interview on 2/18/2022, at 10:00 AM, the alternate administrator indicated social services should evaluate a patient for services if the patient did not have a caregiver or lived alone. At 11:04 AM, the alternate administrator indicated the social worker should have been called. 6. During an interview at the entrance conference on 2/14/2022, at 10:14 AM, the alternate administrator indicated the agency provided PT and social work services. 17-13-1(a)

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 record review and interview, the agency failed to ensure services were provided to the patient as directed in the plan of care in 7 of 7 clinical records reviewed. (#1, #2, #3, #4, #5, #6, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” revised February 2021, stated, “… Each patient must receive the home health services that are written in an individualized plan of care ….” 2. Clinical record review on 2/16/2022, for patient # 1, start of care 9/4/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022, which was signed by the physician on 1/23/2022. This document indicated the patient was to receive skilled nursing services one time a week for 9 weeks. Review failed to indicate the patient received skilled nursing services during the week of 1/30/2022 as directed in the plan of care. Review of an agency document titled “Missed Visit”, signed and dated by the registered nurse (RN) D on 2/1/2022, indicated the patient refused the visit. This document failed to evidence the patient was offered to reschedule the visit during the week of 1/30/2022. During an interview on 2/28/2022, at 11:43 AM, the alternate administrator indicated the agency did not provide skilled nursing services during the week of 1/30/2022 as directed in the plan of care. 3. Clinical record review on 2/17/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, which was signed by the physician on 2/4/2022. This document indicated the patient was to receive skilled nursing services 1 time a week for 9 weeks. Review failed to evidence skilled nursing services were provided during the week of 1/30/2022 as directed in the plan of care. Review of an agency document titled “Missed Visit”, electronically signed and dated by RN D on 2/3/2022, indicated the patient refused the visit. This document failed to evidence the patient was offered to reschedule the visit during the week of 1/30/2022. During an interview on 2/18/2022, at 12:27 PM, the alternate administrator indicated the agency did not provide a skilled nurse visit during the week of 1/30/2022. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/8/2022 – 3/8/2022, which was signed by the physician on 2/4/2022. This document indicated the patient was to receive home health aide (HHA) services 2 times a week for 8 weeks beginning the week of 1/9/2022. Review failed to evidence HHA services were provided 2 times during the week of 1/16/2022, 1/23/2022, 1/30/2022, 2/6/2022, and 2/13/2022, as directed in the plan of care. Review of agency documents titled “Missed Visit”, electronically signed and dated by home health aide (HHA) E and dated 1/20/2022, 1/25/2022, 2/1/2022, 2/8/2022, and 2/15/2022, indicated the family/caregiver was able to assist the patient. Review failed to evidence the reason for the missed visits and failed to evidence the patient was offered to reschedule the visit during the week of 1/16/2022, 1/23/2022, 1/30/2022, 2/6/2022, and 2/13/2022. Review of an agency document titled “PT [physical therapy] Plan of Care”, electronically signed by PT I and dated 1/12/2022, indicated the patient was to receive PT services 1 time a week for 1 week and 2 times a week for 4 weeks. Review failed to evidence the patient received PT services during the week of 1/23/2022, week 3 of PT services, and during the week of 1/30/2022, week 4 of PT services, as ordered in the plan of care. Review of agency documents titled “Missed Visit” electronically signed by PT I, indicated the patient refused the PT visit because he was tired on the document dated 1/25/2022. Review of the document dated 1/27/2022 and 2/1/2022 indicated the patient refused the PT visits. Review failed to evidence the patient was offered to reschedule the visits during the week of 1/23/2022 and 1/30/2022. During an interview on 2/21/2022, at 1:43 PM, the alternate administrator indicated there was no documentation of attempts to reschedule the missed visits. 5. Clinical record review on 2/17/2022, for patient #4, start of care 10/1/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed by the physician on 12/16/2021. This document indicated skilled nursing services would be provided 1 time a week for 8 weeks beginning the week of 11/28/2021. Review failed to evidence skilled nursing services were provided during the week of 1/2/2022. Review of an agency document titled “Missed Visit”, electronically signed and dated by licensed practical nurse (LPN) J on 1/5/2022, evidenced the patient refused the visit. Review failed to evidence the patient was offered to reschedule the visit during the week of 1/2/2022. During an interview on 2/18/2022, at 3:49 PM, the alternate administrator indicated skilled nursing services were not provided during the week of 1/2/2022 and indicated there was no documentation the patient was offered to reschedule the visit. 6. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 9/13/2021 – 11/11/2021, which was signed by the physician on 10/6/2021. This document indicated skilled nursing services were to be provided 1 time a week for 9 weeks. Review failed to evidence skilled nursing services were provided during the week of 9/26/2021 as directed in the plan of care. Review of an agency document titled “Missed Visit”, electronically signed by the alternate administrator and dated 9/29/2021, evidenced the patient refused the visit. Review failed to evidence the patient was offered to reschedule the visit during the week of 9/26/2021. During an interview on 2/18/2022, at 4:11 PM, the alternate administrator indicated skilled nursing services were not provided during the week of 9/26/2021 and indicated there was no documentation the patient was offered to reschedule the visit. 7. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the agency was to provide skilled nursing services 1 time a week for 8 weeks beginning the week of 11/28/2021 and indicated the agency was to provide home health aide services 2 times a week for 9 weeks. Review failed to evidence the agency provided skilled nursing services as directed in the plan of care during the week of 12/12/2021. Review failed to evidence the agency provided home health aide services 2 times a week as directed in the plan of care during the week of 11/25/2021. Review evidenced agency documents titled “Missed Visit”, electronically signed and dated by HHA C on 11/25/2021 and 11/27/2021, which indicated the family/caregiver was able to assist the patient and failed to evidence the reason for the missed visits. Document electronically signed and dated by RN D on 12/15/2021, indicated the patient refused the visit. Review failed to evidence the patient was offered to reschedule the missed visits. During an interview on 2/18/2022, at 10:33 AM, the alternate administrator indicated the agency did not provide home health aide services during the week of 11/25/2021 and indicated the agency did not provide a skilled nursing visit during the week of 12/12/2021. 8. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/19/2021 – 1/17/2022, which was signed by the physician on 12/16/2021. This document indicated skilled nursing services were to be provided 1 time a week for 9 weeks. Review failed to evidence skilled nursing services were provided during the weeks of 12/19/2021, 12/26/2021, and 1/2/2022 as directed in the plan of care. Review of agency documents titled “Missed Visit”, electronically signed and dated by RN F on 12/21/2021, 12/28/2021, and 1/4/2022, indicated the patient refused the visit. Review failed to evidence the patient was offered to reschedule the missed visits. During an interview on 2/18/2022, at 11:18 AM, the alternate administrator indicated skilled nursing services were not provided during the weeks of 12/21/2021 and 12/28/2021. The alternate administrator indicated there were no offers to reschedule the visits. 9. During an interview on 1/21/2022, at 1:27 PM, the alternate administrator indicated the missed visit document should indicate why the visit was missed and if the patient was offered to reschedule the visit. 17-13-1(a)

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 observation, record review, and interview, the agency failed to ensure the plan of care was individualized to include all medications, services, treatments, and patient-specific interventions in 5 of 7 clinical records reviewed. (#1, #2, #3, #6, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” revised February 2021, stated, “… The individualized plan of care must include the following: … The types of services, supplies and equipment required … All medications and treatments … Patient-specific interventions and education, measurable outcomes and goals ….” 2. Clinical record review on 2/16/2022, for patient # 1, start of care 9/4/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022. This document indicated the skilled nurse was to report to the physician if unrelieved pain was more than 6 on a scale of 0 – 10 and indicated the skilled nurse was to report to the physician if severe pain rated more than 7 on a scale of 0 – 10 was not relieved with pain medication. This document indicated the skilled nurse was to provide skilled nursing services 1 time a week for 9 weeks. This document indicated the patient’s safety precautions included oxygen precautions and indicated the patient used oxygen as needed. The patient’s medication included Breo Ellipta (an inhaled medication used to treat chronic obstructive pulmonary disease and asthma). Review of agency documents titled “SN [skilled nurse] Wound Care Visit” dated 12/29/2021, 1/5/2022, 1/12/2022, 1/19/2022, 1/26/2022, 2/9/2022, and signed by registered nurse (RN) D, indicated the RN filled the pill box. The plan of care failed to evidence the skilled nursing services included the fill of the pill box. During an interview on 2/18/2022, at 11:39 AM, the alternate administrator indicated the plan of care was unclear with what pain rating should be reported to the physician and indicated the plan of care should not have different pain reporting parameters for when to notify the physician. At 11:54 AM, the alternate administrator indicated the plan of care should include the skilled nursing intervention of filling the pill box. During an observation of care at the patient’s home on 2/16/2022, at 9:59 AM, no oxygen or oxygen supplies were observed in the patient’s home. The patient indicated she no longer uses oxygen and had the oxygen supply company pick up her oxygen a long time ago. The patient’s medications were observed, and Breo Ellipta was not observed in the patient’s medications. The patient indicated she no longer took her inhaler medication. Home Health Aide (HHA) C was observed applying lotion from a bottle labeled “Ammonium Lactate” (a topical medication used to treat dry, scaly skin conditions) to the patient’s legs. Review failed to evidence the plan of care was individualized to reflect the patient’s current medication and safety precautions. Patient was observed wearing incontinence briefs. Review failed to evidence the plan of care included incontinence briefs were included in the patient’s medical supplies. During an interview on 2/18/2022, at 11:55 AM, the alternate clinical manager indicated oxygen should not be listed on the plan of care if the patient was not using it. At 12:00 PM, the alternate administrator indicated the ammonium lactate was not included on the plan of care but should be. At 12:02 PM, the alternate administrator indicated the Breo Ellipta inhaler should not be included on the plan of care if the patient was no longer taking the medication. At 12:03 PM, the alternate administrator indicated incontinence briefs should be included in the patient’s supplies on the plan of care. 3. During an observation of care on 2/16/2022, at 10:58 AM, at the home of patient #2, start of care 7/16/2021, an oxygen concentrator (a medical device for oxygen therapy) and an oxygen tank were observed in the corner of the patient’s bedroom. Clinical record review on 2/17/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, dated and electronically signed by RN D on 1/7/2022, which indicated the patient was NPO (nothing by mouth) and received tube feedings of Diabetic Source (a type of tube feeding formula) 2 cans four times a day through his gastrostomy. Review indicated the patient was to receive 100 milliliters (ml) of water through the gastrostomy before and after tube feedings. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022. This document evidenced the patient’s diagnoses included, but were not limited to, pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the left and right buttocks, gastrostomy (a tube surgically inserted into the stomach through the abdomen used to administer nutrition, fluid, and/or medication), and diabetes (a chronic condition which affects the way the body processes blood sugar). This document indicated the skilled nurse was to provide stoma (an opening in the body) care at the gastrostomy site and failed to evidence what the individualized care was to be provided at the site. This document indicated the patient was NPO (nothing by mouth). Review of this document indicated the patient had a foley catheter (an indwelling plastic tube inserted into the bladder to drain urine), which the skilled nurse was to change monthly. This document indicated the nurse was to inflate the catheter balloon to 10 milliliters (ml), and the plan of care failed to evidence with what substance the balloon was to be inflated. Review of the plan of care indicated blood sugar parameters for the patient and failed to evidence patient-specific goals related to the diagnosis of diabetes. This document indicated the patient was NPO and received tube feedings and failed to evidence the type of formula, the amount, and the frequency of the tube feedings the patient received. Review failed to evidence the water flushes through the gastrostomy the patient was to receive. This document failed to include oxygen and aspiration (when food, fluid or another substance enters the airway or lungs accidentally, may occur when there is difficulty with swallowing) precautions as individualized patient safety measures. During an interview on 2/18/2022, at 12:08 PM, the alternate administrator indicated the stoma care was probably to clean the site with normal saline (a solution used to clean wounds) and apply a split gauze. At 12:16 PM, the alternate administrator indicated the oxygen precautions should have been included on the plan of care. At 12:17 PM, the alternate administrator indicated aspiration precautions should have been included in the comprehensive assessment due to the patient’s NPO status. At 12:19 PM, the alternate administrator indicated the foley catheter balloon was to be inflated with normal saline and indicated it should be included in the plan of care. At 12:20 PM, the alternate administrator indicated patient-specific goals that should have been included on the plan of care related to the diagnosis of diabetes included blood sugars would remain within a specific range and the patient would not have any signs and symptoms of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar). During an interview on 2/21/2022, at 1:14 PM, the alternate clinical manager indicated the information about the tube feedings and the water flushes should be included on the plan of care. Review of agency documents titled “SN [skilled nurse] Wound Care Visit” dated 1/18/2022, and signed by RN D, indicated the RN filled the pill box. The plan of care failed to evidence the skilled nursing services included the fill of the pill box. During an interview on 2/18/2022, at 12:25 PM, the alternate administrator indicated all skilled nursing interventions should be listed on the plan of care including the fill of the pill box. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/8/2022 – 3/8/2022. This document indicated the skilled nurse was to report to the physician if unrelieved pain was more than 6 on a scale of 0 – 10 and indicated the skilled nurse was to report to the physician if severe pain rated more than 7 on a scale of 0 – 10 was not relieved with pain medication. During an interview on 2/21/2022, at 1:15 PM, the alternate administrator indicated she was unsure what the patient’s individualized pain parameter was and indicated it was unclear on the plan of care. Clinical record review on 2/21/2022, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit”, electronically signed by licensed practical nurse (LPN) H and dated 1/25/2022. This document indicated the LPN assessed the patient’s pain to be rated 2 on a scale of 0-10. This document indicated the patient’s pain was relieved by medication. The plan of care failed to evidence a medication for pain was included. During an interview on 2/21/2022, at 1:33 PM, the alternate administrator indicated she was unsure what pain medication the patient was taking and indicated it should have been included on the plan of care. 5. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “OASIS-D1 Recertification”, electronically signed and dated by RN D on 11/22/2021. This document indicated the patient lived alone with no available caregivers. During an interview on 2/16/2022, at 11:55 AM, RN D indicated the patient lives alone. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the patient’s discharge plan was to discharge to the care of the caregiver and indicated the caregiver was to demonstrate the necessary skills to aid the patient in managing disease process. Review failed to evidence the plan of care was individualized to include discharge plans for the patient living alone without a caregiver. During an interview on 2/18/2022, at 11:04 AM, the alternate administrator indicated the patient lived alone, did not have a caregiver, and the plan of care was not correct. 6. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/19/2021 – 1/17/2022. This document evidenced the patient’s medications included, but were not limited to, Voltaren gel (a topical pain medication typically used to treat arthritis) daily to affected area for joint paint. The plan of care failed to evidence which joints of the body were affected and where the medication was to be applied. Review of agency documents titled “SN Teaching/Training Visit”, electronically signed by RN F and dated 11/23/2021, 12/2/2021, 12/7/2021, and 12/14/2021, indicated the patient used laxatives (medication used for the treatment of constipation) and/or enemas (a treatment to treat constipation by injecting a solution into the colon through the rectum). Review failed to evidence the plan of care included a laxative medication or enema treatment as documented to be used by the patient. During an interview on 2/18/2022, at 11:16 AM, the alternate administrator indicated there was not a laxative or enema that had been reviewed for potential adverse effects. During an interview on 2/18/2022, at 11:06 AM, the alternate administrator indicated she thought the affected areas where the patient was to apply the Voltaren gel were the patient’s knees but was unsure. At 11:16 AM, the alternate administrator indicated the plan of care did not include the laxative medication or enema treatment. 17-13-1(a)(1)(D)(viii, ix, x, xiii)

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 ensure treatments and services were provided as ordered by the physician in 3 of 7 clinical records reviewed. (#2, #5, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” revised February 2021, stated, “… Drugs, services and treatments are administered by staff only as ordered by physician/practitioner….” 2. Clinical record review on 2/17/2022 and 2/21/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, signed and dated by RN D on 1/7/2022. This document indicated the patient had 2 pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (an open pressure ulcer with partial thickness loss of skin), 1 located on the left buttock and 1 located on the right buttock. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, which was signed by the physician on 2/4/2022, indicated the patient had a pressure ulcer to the left buttock and a pressure ulcer to the right buttock. The document indicated the skilled nurse was to clean the wounds with normal saline (a solution used to clean wounds) and apply barrier ointment. Review of an agency document titled “SN [skilled nurse] Wound Care Visit”, dated and electronically signed by RN D on 2/9/2022, evidenced two new pressure ulcers Stage II to the left lateral buttock. Review of an agency document titled “Physician Order”, electronically signed and dated by the alternate administrator on 2/9/2022, evidenced the 2 wounds to the left lateral buttocks were to be cleaned with normal saline, apply anasept gel (an antimicrobial wound gel) to the wound bed, apply calcium alginate (a highly absorptive wound dressing), and cover with mepilex (a foam dressing) 2 times a week. During an observation of care at the patient’s home on 2/16/2022, at 11:19 AM, the patient was observed lying on his right side with an uncovered, open area to the left buttock and an uncovered, open area to the right buttock. The patient was observed to have a transparent, adhesive dressing to the right buttock on the right side of the uncovered, open area to the right buttock. RN D indicated the uncovered, open area to the left buttock and the uncovered, open area to the right buttock were the original wounds. RN D was observed removing the transparent, adhesive dressing to the right buttock and 2 open areas were observed to the right of the uncovered, open area on the right buttock. At 11:23 AM, RN D was observed spraying a liquid identified by RN D as normal saline on open area to the left buttock and 3 open areas to the right buttock. RN D was observed wiping the open areas with a gauze pad and was observed spreading the skin on the buttock while wiping the open areas. An open area at 5 o’clock from the open area to the left buttock was observed to the inner left buttock. At 11: 25 AM, RN D was observed applying a gel from a bottle labeled “Anasept” to a white material RN D identified as alginate. RN D was observed applying the white material with the gel onto the middle right buttock open area and to the outer right buttock open area. RN D was observed covering the inner right buttock open area, the middle right buttock open area, and the outer right buttock open area with a foam dressing RN D identified as a mepilex dressing. RN D was not observed applying the barrier cream to the inner right buttock open area before covering with the foam dressing as ordered by the physician on the plan of care. RN D was observed applying a cream RN D identified as calmoseptine (a barrier ointment to protect the skin from moisture) to the open area on the left buttock and to the open area at 5 o’clock of the open area on the left buttock on the inner left buttock. During an interview on 2/21/2022, at 12:55 PM, the alternate administrator indicated the skilled nurse should follow the physician order for wound treatments. At 1:08 PM, the alternate administrator indicated she was unsure why the wound documentation from RN D on 2/9/2022 documented the 2 open areas to the left lateral buttocks when RN D identified the 2 observed open areas on the right buttock to be the new wounds. The alternate administrator indicated there was not a wound treatment order for the calmoseptine applied to the open area to the left inner buttock and indicated there was not an order for the anasept and alginate applied to the open areas on the right middle buttock and the right outer buttock. The alternate administrator indicated the physician order on 2/9/2022 was supposed to be for the two new wounds to the right lateral buttock and indicated the RN must have documented the wrong location. The alternate administrator indicated there was not an order for the anasept gel, alginate, and foam dressing that was applied to the right inner buttock. The alternate administrator indicated the RN should have applied barrier cream as indicated in the plan of care. 3. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by licensed practical nurse (LPN) K and dated 9/21/2021. This document indicated the patient had eye lid surgery on 9/16/2021 and the eye had 9 sutures. Review indicated the nurse assessed a surgical wound to the right lateral eye with an incision to include 9 intact sutures with an onset date of 9/16/2021. This document indicated the nurse cleaned the surgical wound with normal saline and left open to air. Review failed to evidence a physician’s order for the treatment to the right eye surgical wound for the cleaning of the wound. During an interview on 2/18/2022, at 4:13 PM, the alternate administrator indicated there was not a physician order for the treatment to the right eye surgical wound. 4. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by RN F and dated 12/2/2021. This document indicated the RN administered the influenza vaccine to the right upper arm. Review failed to evidence an order for the administration of the influenza vaccine. During an interview on 2/16/2022, at 1:44 PM, the alternate administrator indicated the agency obtained a physician order for the influenza vaccine before administering to the patient. During an interview on 2/18/2022, at 11:08 AM, the alternate administrator indicated there should have been a physician order for the influenza vaccine administration. The alternate administrator indicated she would check for an agency policy on the administration of vaccines. No additional information was provided. 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: 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 1 of 7 clinical records reviewed. (#5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Physician/Practitioner Orders – Verbal Orders” revised February 2021, stated, “… When a verbal order is received, the order must be written down … A record of this order is documented on a supplemental order form. … The original order is documented and authenticated by a licensed staff and submitted to the Agency within three (3) business days after receipt(s)….” 2. Clinical record review on 2/17/2022, for patient #5, start of care 2/2/2022, evidenced an agency document titled “SN [skilled nurse] Teaching/Training Visit”, electronically signed by licensed practical nurse (LPN) J and dated 2/9/2022. This document indicated the patient had some pain to the left knee and the nurse obtained an order for diclofenac sodium (a medication used to treat joint pain, swelling, and stiffness) gel. No plan of care was evidenced for the patient. Review failed to evidence a verbal order was written for the diclofenac sodium gel. During an interview on 2/18/2022, at 4:16 PM, the alternate administrator indicated there was not a verbal order written for the diclofenac sodium gel. Review evidenced an unsigned agency document titled “OASIS-D1 Start of Care” with a visit date of 2/2/2022. This document indicated the patient had an unsteady gait, poor balance, had limited range of motion to both lower extremities, required the use of a walker for ambulation, had a history of falls, was at a risk of falls, and had limited endurance. Review failed to evidence the agency offered the patient physical therapy (PT) services and failed to evidence a physician’s order for PT services. During an interview on 2/18/2022, at 4:07 PM, the alternate administrator indicated she had received a verbal order from the patient’s physician for physical therapy services and indicated she had not yet written the verbal order. 17-14-1(a)(H)

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 no less than every 60 days in 4 of 5 clinical records reviewed receiving agency services for at least 60 days. (#1, #2, #4, #6) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” stated, “… The individualized plan of care must be reviewed and revised by the physician/practitioner who is responsible for the home health plan of care and the Agency as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days ….” 2. Clinical record review on 2/16/2022, for patient # 1, start of care 9/4/2020, evidenced agency documents titled “Home Health Certification and Plan of Care”. Review of the document for certification period 8/30/2021 – 10/28/2021, evidenced the plan of care was signed by the physician on 9/2/2021. Review of the document for certification period 10/29/2021 – 12/27/2021, evidenced the plan of care was signed by the physician on 11/10/2021. Review of the document for certification period 12/28/2021 – 2/25/2022, evidenced the plan of care was signed by the physician on 1/23/2022. Review failed to evidence the physician reviewed the plan of care at least every 60 days. 3. Clinical record review on 2/17/2022, for patient #2, start of care 7/16/2021, evidenced agency documents titled “Home Health Certification and Plan of Care”. Review of the document for certification period 11/13/2021 – 1/11/2022, was signed by the physician on 11/29/2021. Review of the document for certification period 1/12/2022 – 3/12/2022, was signed by the physician on 2/4/2022. Review failed to evidence the physician reviewed the plan of care at least every 60 days. 4. Clinical record review on 2/17/2022, for patient #4, start of care 10/1/2020, evidenced agency documents titled “Home Health Certification and Plan of Care”. Review of the document for certification period 9/26/2021 – 11/24/2021 was signed by the physician on 9/30/2021. Review of the document for certification period 11/25/2021 – 1/23/2022 was signed by the physician on 12/16/2021. Review failed to evidence the physician reviewed the plan of care at least every 60 days. 5. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced agency documents titled “Home Health Certification and Plan of Care”. Review of the document for certification period 9/26/2021 – 11/24/2021 indicated the physician signed the plan of care on 10/12/2021. Review of the document for certification period 11/25/2021 – 1/23/2022 indicated the physician signed the plan of care on 12/16/2021. Review failed to evidence the physician reviewed the plan of care at least every 60 days. 6. During an interview on 2/18/2022, at 11:43 AM, the alternate clinical manager indicated the physician should review the plan of care every 60 days. 17-13-1(a)(2)

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 observation, record review, and interview, the agency failed to ensure the physician was notified of changes in the patient’s condition or needs that suggest outcomes are not being achieved and/or the plan of care should be altered in 4 of 7 clinical records reviewed. (#1, #2, #6, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” revised February 2021, stated, “… The Agency must promptly alert the relevant physician(s)/practitioners to any changes in the patient’s condition or needs that suggest outcomes are not being achieved and/or that the plan of care should be altered….” 2. Review of an agency policy obtained 2/21/2022, titled “Pain Assessment and Reassessment” revised January 2020, stated, “… When a patient’s pain is not relieved, the nurse or therapist will intervene appropriately. Such interventions may include: Notification of patient’s physician ….” 3. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 9:59 AM, home health aide (HHA) C was observed assisting the patient with a sponge bath while the patient sat on the toilet. The patient was observed to have a dry dressing on the right knee. The patient indicated it was a rash and complained of itching to the area. Clinical record review on 2/18/2022, failed to evidence the physician was notified of a rash to include a dry dressing to the patient’s right knee and the patient’s complaint of itching. During an interview on 2/18/2022, at 11:54 AM, the alternate administrator indicated she was not sure what the dressing to the right knee was for and indicated the physician had not been notified of the patient’s rash and dressing to the right knee. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022, signed and dated by the physician on 1/23/2022. This document indicated the patient’s diagnoses included, but were not limited to, a non-pressure ulcer (a wound not related to pressure applied to the skin) to the left great toe, rheumatoid arthritis (a chronic disorder causing pain, stiffness, swelling, and a loss of function in the joints), chronic pain syndrome, spinal stenosis (a narrowing of spaces within the spine putting pressure on the nerves), and spondylosis (degenerative wear and tear of the spinal discs). This document evidenced the patient’s medications included, but were not limited to, Acetaminophen (a medication used to treat pain and fever) 1000 milligrams (mg) every 8 hours as needed for pain rated 1-3 on a scale of 0-10. This document failed to evidence the patient’s medications included any other medication used to treat pain. Review evidenced the goals included, but were not limited to, the patient would have a decrease in pain to a tolerable level of 0-2 on a scale of 0-10 within 1-2 weeks. Review of agency documents titled “SN [skilled nurse] Wound Care Visit”, dated 12/29/2021 and 1/5/2022, and electronically signed by RN D, evidenced the patient’s pain was rated 4 on a scale of 0-10 and assessed to be daily. Documents dated 1/12/2022, 1/19/2022, 1/26/2022, and 2/9/2022, and electronically signed by registered nurse (RN) D, indicated the patient had pain rated 5 on a scale of 0-10 and assessed to be daily. Review failed to evidence the patient’s medication included a pain medication for the treatment of pain rated greater than 3 on a scale of 0-10. Review failed to evidence the agency contacted the physician regarding the patient’s pain level was assessed to be greater than 3, which the patient’s only pain medication was ordered to use for pain 1-3 on a scale of 0-10. During an interview on 2/18/2022, at 12:04 PM, the alternate administrator indicated the physician had not been notified of the patient’s pain rating and indicated the agency should contact the physician to get other pain medication orders. 4. Clinical record review on 2/17/2022 and 2/21/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, signed and dated by RN D on 1/7/2022. This document indicated the patient had 2 pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (an open pressure ulcer with partial thickness loss of skin), 1 located on the left buttock and 1 located on the right buttock. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, which was signed by the physician on 2/4/2022, indicated the patient had a pressure ulcer to the left buttock and a pressure ulcer to the right buttock. The document indicated the skilled nurse was to clean the wounds with normal saline (a solution used to clean wounds) and apply barrier ointment. Review of an agency document titled “SN [skilled nurse] Wound Care Visit”, dated and electronically signed by RN D on 2/9/2022, evidenced two new pressure ulcers Stage II to the left lateral buttock. Review of an agency document titled “Physician Order”, electronically signed and dated by the alternate administrator on 2/9/2022, evidenced the 2 wounds to the left lateral buttocks were to be cleaned with normal saline, apply anasept gel (an antimicrobial wound gel) to the wound bed, apply calcium alginate (a highly absorptive wound dressing), and cover with mepilex (a foam dressing) 2 times a week. During an observation of care at the home of patient #2 on 2/16/2022, at 11:19 AM, the patient was observed lying on his right side with an uncovered, open area to the left buttock and an uncovered, open area to the right buttock. The patient was observed to have a transparent, adhesive dressing to the right buttock on the right side of the uncovered, open area to the right buttock. RN D indicated the uncovered, open area to the left buttock and the uncovered, open area to the right buttock were the original wounds. RN D was observed removing the transparent, adhesive dressing to the right buttock and 2 open areas were observed to the right of the uncovered, open area on the right buttock. At 11:23 AM, RN D was observed spraying a liquid identified by RN D as normal saline on open area to the left buttock and 3 open areas to the right buttock. RN D was observed wiping the open areas with a gauze pad and was observed spreading the skin on the buttock while wiping the open areas. An open area at 5 o’clock from the open area to the left buttock was observed to the inner left buttock. At 11: 25 AM, RN D was observed applying a gel from a bottle labeled “Anasept” to a white material RN D identified as alginate. RN D was observed applying the white material with the gel onto the middle right buttock open area and to the outer right buttock open area. RN D was observed covering the inner right buttock open area, the middle right buttock open area, and the outer right buttock open area with a foam dressing RN D identified as a mepilex dressing. RN D was not observed applying the barrier cream to the inner right buttock open area before covering with the foam dressing as ordered by the physician on the plan of care. RN D was observed applying a cream RN D identified as calmoseptine (a barrier ointment to protect the skin from moisture) to the open area on the left buttock and to the open area at 5 o’clock of the open area on the left buttock on the inner left buttock. Review of an agency document on 2/21/2022, titled “SN Wound Care Visit”, dated and electronically signed by RN D on 2/16/2022, indicated barrier ointment was applied to the right and left buttock wounds. This document indicated anasept gel, calcium alginate, and a mepilex dressing was applied to the two left lateral buttock wounds. This document failed to evidence the physician was notified of the observed open area locations to the right inner buttock and the right outer buttock. This document failed to evidence the physician was notified of the open area to the left inner buttock. During an interview on 2/21/2022, at 1:08 PM, the alternate administrator indicated she was unsure why the wound documentation from RN D on 2/9/2022 documented the 2 open areas to the left lateral buttocks when RN D identified the 2 observed open areas on the right buttock to be the new wounds. The alternate administrator indicated there was not a wound treatment order for the calmoseptine applied to the open area to the left inner buttock and indicated there was not an order for the anasept and alginate applied to the open areas on the right middle buttock and the right outer buttock. The alternate administrator indicated the physician order on 2/9/2022 was supposed to be for the two new wounds to the right lateral buttock and indicated the RN must have documented the wrong location. The alternate administrator indicated the physician had not been notified of the correct wound location and indicated the physician should have been notified of the new area observed to the left inner buttock. 5. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the patient’s diagnoses included, but were not limited to, gout (a form of arthritis causing severe pain, redness, and swelling). This document evidenced the patient’s medications included, but were not limited to, Tylenol (a medication used to treat pain and fever) 650mg every 8 hours as needed for pain rated 1-3 on a scale of 0-10. This document failed to evidence the patient’s medications included any other medication used to treat pain. Review evidenced the goals included, but were not limited to, the patient would have a decrease in pain to a tolerable level of 0-2 on a scale of 0-10 within 1-2 weeks. Review evidenced agency documents titled “SN Teaching/Training Visit”, electronically signed by RN D and dated 12/2/2021, 12/9/2021, 12/23/2021, 12/30/2021, 1/3/2022, and 1/20/2022, indicated the patient’s pain was rated 5 on a scale of 0-10 and indicated the pain was daily. Review failed to evidence the patient’s medication included a pain medication for the treatment of pain rated greater than 3 on a scale of 0-10. Review failed to evidence the agency contacted the physician regarding the patient’s pain level was assessed to be greater than 3, which the patient’s only pain medication was ordered to use for pain 1-3 on a scale of 0-10. During an interview on 2/18/2022, at 11:00 AM, the alternate administrator indicated the agency should have called the physician to inform him of the patient’s pain level and ask for an order for pain medication that would better treat the patient’s pain. 6. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/19/2021 – 1/17/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the patient’s diagnoses included, but were not limited to, fracture of the left femur (long bone located in the upper leg). This document evidenced the patient’s medications included, but were not limited to, Tylenol (a medication used to treat pain and fever) 650mg every 8 hours as needed for pain rated 1-3 on a scale of 0-10 and Voltaren gel (a topical pain medication typically used to treat arthritis) daily. This document failed to evidence the patient’s medications included any other medication used to treat pain. Review evidenced the goals included, but were not limited to, the patient would have a decrease in pain to a tolerable level of 0-2 on a scale of 0-10 within 1-2 weeks. Review evidenced agency documents titled “SN Teaching/Training Visit” signed by RN F and dated 11/23/2021 and 12/2/2021, which indicated the patient had daily pain to the joints rated 4 on a scale of 0-10. Documents dated 12/7/2021 indicated the patient had daily pain to the left lower extremity rated 5 on a scale of 0-10. Document dated 12/14/2021 indicated the patient had daily pain to the left lower extremity rated 4 on a scale of 0-10. Review failed to evidence the agency contacted the physician regarding the patient’s pain level was assessed to be greater than 3. During an interview on 2/18/2022, at 11:05 AM, the alternate administrator indicated the agency should have notified the physician the patient’s pain was not managed and requested an order for another pain medication. 17-13-1(a)(2)

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, agency failed to ensure the plan of care was revised to reflect the patient’s current status in 4 of 7 clinical records reviewed. (#1, #2, #3, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Plan of Care – CMS [Centers for Medicare and Medicaid Services] #485 [a document used by the home care agency and serves as the plan of care] and Physician/Practitioners Orders” revised February 2021, stated, “… 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 Agency and patient in the plan of care….” 2. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 9:59 AM, home health aide (HHA) C was observed assisting the patient with a sponge bath while the patient sat on the toilet. The patient was observed to have a dry dressing on the right knee. The patient indicated it was a rash and complained of itching to the area. The HHA was not observed reporting the dry dressing, the rash, and the patient’s complaint of itching to the RN. Clinical record review on 2/18/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022. This document failed to evidence the plan of care was revised to include treatment for a rash to include a dry dressing to the patient’s right knee. During an interview on 2/18/2022, at 11:54 AM, the alternate administrator indicated she was not sure what the dressing to the right knee was for and indicated the plan of care had not been revised to include the patient’s rash and dressing to the right knee. 3. Clinical record review on 2/17/2022 and 2/21/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, signed and dated by registered nurse (RN) D on 1/7/2022. This document indicated the patient had 2 pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (an open pressure ulcer with partial thickness loss of skin), 1 located on the left buttock and 1 located on the right buttock. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, which was signed by the physician on 2/4/2022, indicated the patient had a pressure ulcer to the left buttock and a pressure ulcer to the right buttock. The document indicated the skilled nurse was to clean the wounds with normal saline (a solution used to clean wounds) and apply barrier ointment. Review of an agency document titled “SN [skilled nurse] Wound Care Visit”, dated and electronically signed by registered nurse (RN) D on 2/9/2022, evidenced two new pressure ulcers Stage II to the left lateral buttock. Review of an agency document titled “Physician Order”, electronically signed and dated by the alternate administrator on 2/9/2022, evidenced the 2 wounds to the left lateral buttocks were to be cleaned with normal saline, apply anasept gel (an antimicrobial wound gel) to the wound bed, apply calcium alginate (a highly absorptive wound dressing), and cover with mepilex (a foam dressing) 2 times a week. Review failed to evidence the plan of care was revised and updated to reflect the patient’s 2 wounds to the left lateral buttock and the new treatment order. During an interview on 2/21/2022, at 12:59 PM, the alternate administrator indicated the plan of care had not been updated to include the 2 wounds to the left lateral buttock and the treatment order. The alternate administrator asked, “Should the plan of care be revised?” 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “SN Wound Care Visit”, electronically signed by licensed practical nurse (LPN) H and dated 2/10/2022. Review evidenced the LPN assessed skin tear wounds to the left lower extremity with an onset date of 2/10/2022. Review of an agency document titled “Physician Order”, signed and dated by the physician on 2/18/2022, indicated the wound care to the left lower leg was to clean the wound with wound wash, apply anasept gel, cover with telfa (a nonadhesive dressing), and wrap with coban (a self-adhering bandage) 2 times a week. During an observation of care at the home on 2/18/2022, at 1:15 PM, the patient was observed to have 20+ scabbed areas on the left shin and 8 scabbed areas on the right shin. No dressing was noted to the patient’s scabbed areas. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 1/8/2022 – 3/8/2022, failed to evidence the plan of care had been revised to reflect the wounds to the left and right lower extremities and failed to evidence the wound treatment ordered for the left lower extremity. During an interview on 2/21/2022, at 1:57 PM, the alternate administrator indicated the plan of care had not been revised to include the wounds to the bilateral lower extremities. 5. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by LPN K and dated 9/21/2021. This document indicated the patient had eye lid surgery on 9/16/2021 and the eye had 9 sutures. Review indicated the nurse assessed a surgical wound to the right lateral eye with an incision to include 9 intact sutures with an onset date of 9/16/2021. This document indicated the nurse cleaned the surgical wound with normal saline and left open to air. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 9/13/2021 – 11/11/2021, failed to evidence the plan of care was revised to include the surgical wound and treatment to the right eye. During an interview on 2/18/2022, at 4:13 PM, the alternate administrator indicated the plan of care was not revised to reflect the surgical wound and treatment to the right eye. 6. During an interview on 2/18/2022, at 12:25 PM, the alternate administrator indicated the plan of care consisted of the CMS (Centers for Medicare and Medicaid Services) form 485. 17-14-1(a)(1)(C)

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 were communicated to the physician responsible for the plan of care in 2 of 2 closed clinical records reviewed. (#6, #7) The findings include: 1. Review of an agency policy obtained 2/15/2022, titled “Discharge Criteria and Planning” revised February 2021, stated, “… The patient is informed of discharge plan in a timely manner … Physician and other care providers will be informed and knowledgeable of discharge….” 2. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the patient was to receive skilled nursing services 1 time a week for 8 weeks beginning the week of 11/28/2021 and home health aide services 2 times a week for 9 weeks. This document indicated the patient’s goals included, but were not limited to, have a tolerable level of pain rated 0-2 on a scale of 0-10, have absence of edema (swelling), and would not have signs and symptoms of complications related to hemorrhoids. Review evidenced the discharge plan was to discharge when the patient demonstrated necessary skills to self-manage disease process and when the patient’s pain level stabilized. Review evidenced agency documents titled “SN [skilled nursing] Teaching/Training Visit”, electronically signed by registered nurse (RN) D. Review of documents dated 12/2/2021, 12/9/2021, 12/23/2021, 12/30/2021, 1/3/2022, and 1/20/2022, indicated the patient had daily pain to the knees rated 5 on a scale of 0-10. These documents indicated the patient had rectal bleeding from hemorrhoids and indicated the patient had 1+ pitting edema to the legs. Review evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Discharge”, electronically signed by RN D and dated 1/19/2022. This document indicated the patient had generalized pain the time rated 3 on a scale of 0-10. Review indicated the patient had edema to the lower extremities and had hemorrhoids with rectal bleeding. Review indicated the reason for discharge was the patient’s goals were met. Review failed to evidence the patient met goals and failed to evidence the agency communicated the change in discharge plans to the patient and physician. During an interview on 2/18/2022, at 11:02 AM, the alternate administrator indicated the patient did not meet goals and indicated the physician was not made aware of the change in discharge plans to discharge the patient without goals being met. 3. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/19/2021 – 1/17/2022, which was signed by the physician on 12/16/2021. Review evidenced an agency document titled “OASIS-D1 Discharge”, electronically signed by the alternate administrator and dated 1/13/2022. This document indicated the patient was discharged from the agency on 1/13/2022 per patient request. Review failed to evidence documentation of communication with the patient/caregiver regarding the patient’s request to discharge. During an interview on 2/14/2022, at 5:10 PM, the patient’s caregiver indicated the patient did not request to be discharged from the agency and indicated the patient was still receiving services from the agency. The patient’s caregiver indicated the agency informed him the patient needed to be recertified but was not informed that the agency had discharged the patient. During an interview on 2/18/2022, at 11:22 AM, the alternate administrator indicated the patient was discharged because the patient had refused skilled nursing visits. The administrator indicated there was no documentation of communication with the physician regarding the potential discharge from the agency due to missed visits.

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 observation, record review, and interview, the agency failed to coordinate care of services provided to the patient in 2 of 2 clinical records reviewed with physical therapy services. (#3, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Coordination of Patient Care” revised February 2021, stated, “… The Agency must: … 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 by all disciplines….” 2. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Start of Care”, electronically signed by registered nurse (RN) F and dated 1/8/2022. This document indicated the patient had pain to the lower extremity rated 4 on a scale from 0-10. This document failed to evidence the patient had pitting edema (excess fluid built up in the body and when pressure is applied, causes an indentation). This document indicated the patient was to receive skilled nursing services 1 time a week for 2 weeks and then 2 times a week for 7 weeks and home health aide (HHA) services 2 times a week for 8 weeks. Review of an agency document titled “PT [physical therapy] Plan of Care”, electronically signed by PT I and dated 1/12/2022, indicated the patient was to receive PT services 1 time a week for 1 week and 2 times a week for 4 weeks. Review evidenced agency documents titled “SN [skilled nurse] Wound Care Visit”, electronically signed by licensed practical nurse (LPN) H. Review of documents dated 1/14/2022, 1/17/2022, and 1/20/2022, evidenced the LPN assessed the patient to have no pain. Review of the document dated 1/25/2022, evidenced the LPN assessed the patient’s pain rated 2 on a scale from 0-10 to the buttocks. Review failed to evidence the LPN coordinated care with the RN, HHA, and PT and informed them of the patient’s new pain location to the buttocks. Review of the document dated 2/10/2022, evidenced the LPN assessed skin tear wounds to the left lower extremity. Review failed to evidence the LPN coordinated care with the HHA and PT and informed them of the patient’s new wounds to the left lower extremity. Review of the documents dated 2/8/2022, 2/10/2022, and 2/14/2022, indicated the patient had pitting edema at a degree of 2+ on a scale of 0 to 4+. Review of these documents failed to evidence the LPN notified and coordinated care with the RN, PT, and HHA regarding the pitting edema. During an observation of care at the home on 2/18/2022, at 1:15 PM, the patient was observed to have swollen lower extremities between the knees and ankles. During an interview at the patient’s home on 2/18/2022, at 1:15 PM, the patient’s caregiver indicated the patient’s legs weep (severe swelling that causes fluid to leak from the skin) from the swelling. The patient’s caregiver indicated the patient has neuropathy (damage to the nerves most often to the hands and feet and a common symptom of diabetes) and has fallen over a dozen times to include the most recent fall 3 weeks ago. Review of an agency document titled “Incident Log”, electronically singed by LPN H and dated 1/31/2022, evidenced the patient had a fall without injury while attempting to stand up. This document failed to evidence the PT was notified regarding the patient’s fall. During an interview on 2/21/2022, at 1:34 PM, the alternate administrator indicated the LPN should have informed the other disciplines involved in the patient’s care of the new location of pain so the pain could be monitored. At 1:47 PM, the alternate administrator indicated the LPN should have communicated to the HHA and PT providing care to the patient so they were aware of the new wounds. At 2:03 PM, the alternate administrator indicated staff involved in the care of the patient was not notified of the swelling. At 2:37 PM, the alternate administrator indicated the PT should have been notified so the PT could work on strengthening and ambulation with the patient. 3. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “OASIS-D1 Start of Care”, electronically signed and dated by RN F on 11/20/2021. This document indicated the patient had generalized pain rated a 4 on a scale of 0-10. This document indicated the patient received services by agency B. Review failed to evidence care coordination to include the type and frequency of services provided by agency B. During an interview on 2/18/2022, at 11:36 AM, the alternate administrator indicated she thought agency B provided homemaker services and was unsure of the frequency agency B provided services. Review of an agency document titled “PT Evaluation”, electronically signed and dated by PT L on 12/8/2021, evidenced the patient had moderate pain to the left shoulder. Review failed to evidence the PT coordinated care with the RN regarding the new location of pain to the left shoulder. This document indicated PT was to provide services 2 times a week for 4 weeks. During an interview on 2/18/2022, at 11:14 AM, the alternate administrator indicated the PT did not document care coordination with the RN regarding the left shoulder pain and indicated the PT should have called the RN. Review evidenced agency documents titled “SN Teaching/Training Visit”, electronically signed by RN F. The document dated 12/7/2021, indicated the patient had pain to the left lower extremity rated 5 on a scale of 0-10 and pain to the left lower extremity rated 4 on a scale of 0-10. Review failed to evidence the RN coordinated care with the PT regarding the new location of pain to the left lower extremity. During an interview on 2/18/2022, at 11:17 AM, the alternate administrator indicated the RN should have notified the PT to coordinate care regarding the patient’s pain to the left lower extremity so PT could have tried to alleviated pain with movement. 17-12-2(g) 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 agency failed to provide the patient and caregiver in writing with a copy of the visit schedule in 3 of 3 home visits conducted. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Patient Bill of Rights and Responsibilities” revised February 2021, stated, “… Patients have the right: … To be informed of: Visit schedule and frequency ….” 2. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 10:18 AM, an agency folder was not observed in the home. The written visit schedule was not observed to have been provided to the patient. 3. During an observation of care at the home of patient #2, start of care 7/16/2021, on 2/16/2022, at 11:25 AM, the agency home folder was observed in the patient’s bedroom. Inside of the agency folder, a blank calendar was observed. The written visit schedule was not observed to have been provided to the patient. 4. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/18/2022, at 1:08 PM, the agency home folder was observed in the patient’s home. A written visit schedule was not observed in the folder or in the patient’s home. 5. During an interview on 2/18/2022, at 10:02 AM, the alternate clinical manager indicated patients are provided a written copy of their visit schedule by a blank calendar that is provided inside of the agency home folder that is provided to the patients. The alternate administrator indicated staff is to fill out the calendar with their planned visits.

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 the patient and caregiver in writing with a copy of the medication schedule and instructions in 3 of 3 home visits conducted. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Patient Bill of Rights and Responsibilities” revised February 2021, stated, “… Patients have the right: … To be informed of: … Patient medication schedule/instructions ….” 2. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 10:18 AM, an agency folder was not observed in the home. A written copy of the medication schedule and instructions was not observed to have been provided to the patient. 3. During an observation of care at the home of patient #2, start of care 7/16/2021, on 2/16/2022, at 11:25 AM, the agency home folder was observed in the patient’s bedroom. A written copy of the medication schedule and instructions was not observed in the folder or in the patient’s home. 4. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/18/2022, at 1:08 PM, the agency home folder was observed in the patient’s home. A written copy of the medication schedule and instructions was not observed in the folder or in the patient’s home. 5. During an interview on 2/18/2022, at 10:02 AM, the alternate clinical manager indicated patients are provided a copy of their medication list and indicated the skilled nurse should check for the medication list at every home visit and replace it if needed.

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 with the treatments to be administered by agency personnel in 3 of 3 home visits conducted. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Patient Bill of Rights and Responsibilities” revised February 2021, stated, “… Patients have the right: … To be informed of: … Treatments to be administered by Agency staff ….” 2. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 10:18 AM, an agency folder was not observed in the home. A written copy of the treatments to be provided by the agency personnel was not observed to have been provided to the patient. 3. During an observation of care at the home of patient #2, start of care 7/16/2021, on 2/16/2022, at 11:25 AM, the agency home folder was observed in the patient’s bedroom. A written copy of the treatments to be provided by the agency personnel was not observed in the agency folder and was not observed to be provided to the patient. 4. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/18/2022, at 1:08 PM, the agency home folder was observed in the patient’s home. A written copy of the treatments to be provided by the agency personnel was not observed in the folder or in the patient’s home. 5. During an interview on 2/18/2022, at 10:02 AM, the alternate clinical manager indicated the patients are not provided a copy of their specific treatments provided by the agency. The alternate administrator indicated the packet inside of the agency folder that was provided to the patient upon admission listed which services the agency provided.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. 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 with the name and contact information of the clinical manager in 3 of 3 home visits conducted. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Patient Bill of Rights and Responsibilities” revised February 2021, stated, “… Patients have the right: … To be informed of: … Name of clinical manager … and contact information ….” 2. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 10:18 AM, an agency folder was not observed in the home. The name and contact information of the clinical manager was not observed to have been provided to the patient. 3. During an observation of care at the home of patient #2, start of care 7/16/2021, on 2/16/2022, at 11:25 AM, the agency home folder was observed in the patient’s bedroom. The name and contact information of the clinical manager was not observed in the agency folder and was not observed to have been provided to the patient. 4. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/18/2022, at 1:08 PM, the agency home folder was observed in the patient’s home. The name and contact information of the clinical manager was not observed in the agency folder and was not observed to have been provided to the patient. 5. During an interview on 2/18/2022 at 10:02 AM, the alternate clinical manager indicated the patients had not been provided the name and contact information of the clinical manager and indicated the patient admission folder would be updated to provide the patient the name and contact information of the clinical manager.

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 ensure the performance improvement activities considered incidence, prevalence and severity of problems (see tag G0650); failed to ensure the performance improvement activities lead to an immediate correction of any identified problem that directly or potentially threatens the health and safety of patients (see tag G0652); failed to ensure the performance improvement activities tracked adverse patient events, analyzed their causes and implemented preventative actions (see tag G0654); failed to measure the success of the performance improvement activities and track performance to ensure that improvements are sustained (see tag G0654); and failed to conduct performance improvement projects (see G0658). 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.

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 policy obtained 2/21/2022, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… Data collection must include: … High volume: care/service/process occurs frequently or affects large numbers of patients/staff. Problem prone processes: care/service/process tends to produce problems for patients or staff. Such areas have the potential for negative outcomes and are associated with a diagnosis or condition for a particular patient group or particular component of Agency operation or historical problem areas….” Review of the agency’s QAPI binder on 2/16/2022, evidenced agency documents titled “Quality Assessment Performance Improvement Report”. The document for the 1st quarter of 2021 indicated the agency reported 8 wounds. This document indicated the patient hospitalizations included, but were not limited to, 1 patient for cellulitis (an infection of the skin) and 1 patient for a gangrenous (dead tissue due to a lack of blood flow or infection) foot. The document for the 2nd quarter of 2021 indicated the agency reported 23 wounds and indicated a patient was admitted to the hospital for worsening lower extremity wounds. The document for the 3rd quarter of 2021 indicated the agency reported 24 wounds and indicated 1 patient was admitted to the hospital for cellulitis. The document for the 4th quarter of 2021 indicated the agency reported 29 wounds and indicated 1 patient was admitted to the hospital for a foot wound. These documents indicated the agency’s performance actions for wound improvement were to monitor cellulitis, stasis ulcers (a wound caused by fluid build-up due to poor circulation), pressure ulcers (wound to the skin and underlying tissue resulting from prolonged pressure to the skin), surgical wounds, and other wounds. These documents indicated the agency would monitor wounds present upon admission as well as acquired while being services by the agency. Review failed to evidence a change in the performance improvement activities for wound from the 1st quarter of 2021 to the 4th quarter of 2021. Review failed to evidence the agency’s performance improvement activities addressed the increasing prevalence of the wounds and the severity of the wounds resulting in hospitalization recorded by the agency. During an interview on 2/16/2022, at 2:18 PM, the alternate administrator indicated the performance actions did not change during 2021 to address the increase in prevalence of wounds.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. 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 lead to an immediate correction of any identified problem that directly or potentially threatens the health and safety of patients. The findings include: Review of an agency policy obtained 2/21/2022, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… The QAPI Committee is responsible for taking appropriate action. Aggregate measures of performance for each process will be compared to pre-established performance expectations to determine if additional evaluation is required. If the performance is not met, the findings will be evaluated by the QAPI Committee to determine the systemic approach for making improvement. The systemic approach will include: … Test of strategy/action for change … Analyzing data from the test to determine if change improved performance….” Review of the agency’s QAPI binder on 2/16/2022, evidenced agency documents titled “Quality Assessment Performance Improvement Report”. The document for the 1st quarter of 2021 indicated the agency reported 8 wounds. The document for the 2nd quarter of 2021 indicated the agency reported 23 wounds. The document for the 3rd quarter of 2021 indicated the agency reported 24 wounds. The document for the 4th quarter of 2021 indicated the agency reported 29 wounds. The document for the 2nd quarter of 2021 indicated the agency had 16 patient hospitalizations and the document for the 3rd quarter of 2021 indicated the agency had 19 patient hospitalizations. Review failed to evidence the agency’s performance improvement activities led to an immediate correction of identified problems with hospitalizations and wounds. During an interview on 2/16/2022, at 2:18 PM, the alternate administrator indicated the agency did not have a data to show what performance improvement activities led to immediate improvement. 17-12-2(a)

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 home health agency failed to ensure the performance improvement activities analyzed the causes of adverse patient events and implemented preventive actions. The findings include: Review of an agency policy obtained 2/21/2022, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… The QAPI Committee will compile and analyze collected data. … Such assessment is initiated by: Comparison internally (levels, trends, patterns) … A summary of data collection, analysis, recommendations for improvement and report of cumulative findings will be prepared by the QAPI Committee….” Review of the agency’s QAPI binder on 2/16/2022 evidenced agency documents titled “Quality Assessment Performance Improvement Report”. These documents indicated the agency reported the number of patient falls, the number of patients using antibiotics, the number of patients with wounds, and the number of patients with hospitalizations for each quarter. Review evidenced an agency document titled “QAPI Project Data Collection and Analysis Summary” revised October 2017 and failed to evidence the form was completed. Review failed to evidence the performance improvement activities analyzed the causes of adverse patient events. During an interview on 2/16/2022, at 2:18 PM, the alternate administrator indicated the agency did not have a break-down of data on causes of the adverse patient events. The alternate administrator indicated the agency has not used the QAPI Project Data Collection and Analysis Summary. 17-12-2(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to measure the success of the performance improvement activities and track performance to ensure that improvements are sustained. The findings include: Review of an agency policy obtained 2/21/2022, titled “Quality Assessment and Performance Improvement (QAPI) Plan and Program” stated, “… Aggregate measures of performance for each process will be compared to pre-established performance expectations to determine if additional evaluation is required. If the performance expectation is not met, the findings will be evaluated by the QAPI Committee to determine the systemic approach for making improvement….” Review of the agency’s QAPI binder on 2/16/2022 evidenced an undated agency document titled “Quality Improvement Program Indicators”, which stated, “… The QI [quality improvement] manager will assign records to reviewers. Results will be tabulated. … All problems will have an actions plan developed and will be evaluated until there is evidence of resolution….” Review evidenced agency documents titled “Quality Assessment Performance Improvement Report”. The document for the 1st quarter of 2021 indicated the agency reported 8 wounds. The document for the 2nd quarter of 2021 indicated the agency reported 23 wounds. The document for the 3rd quarter of 2021 indicated the agency reported 24 wounds. The document for the 4th quarter of 2021 indicated the agency reported 29 wounds. These documents indicated the agency’s performance actions for wound improvement were to monitor cellulitis, stasis ulcers (a wound caused by fluid build-up due to poor circulation), pressure ulcers (wound to the skin and underlying tissue resulting from prolonged pressure to the skin), surgical wounds, and other wounds. These documents indicated the agency would monitor wounds present upon admission as well as acquired while being services by the agency. Review failed to evidence the agency monitored the wounds to measure the success of the performance improvement activities. During an interview on 2/16/2022, at 2:18 PM, the alternate administrator indicated the agency does not have a quantitative way of showing things are getting better and stated, “I know that’s big for home health.” The alternate administrator indicated the agency does not complete chart audits, and stated, “We should probably do that.” The alternate administrator indicated the agency does not have any tracking system for wounds to show the type of wounds the patients have, whether the wounds were admitted or acquired, and the data to show whether the wounds were improving or worsening. 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 document a performance improvement project. The findings include: Review of an agency policy obtained 2/21/2022, titled “Performance Improvement Projects” revised March 2018, stated, “… The Agency will document the quality improvement projects undertaken, the reasons for conducting these projects and the measurable progress achieved on these projects … The Agency should have one performance improvement project either in development, ongoing or completed each calendar year….” Review of the agency’s QAPI binder on 2/16/2022, failed to evidence the agency had a performance improvement project. During an interview on 2/16/2022, at 2:18 PM, the administrator indicated he does not recall doing a performance improvement project in the past. The administrator indicated he would like to monitor the trends on falls but has not implemented that yet.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure: the agency followed accepted standards of practice for standard/universal precautions to prevent the transmission of infections (see tag G0682); staff was educated on infection control (see tag G0686); and policies and procedures were developed and implemented to ensure all staff are fully vaccinated for COVID-19 (see tag G0687). 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 484.70 Infection Control.

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/universal precautions to prevent the transmission of infections and failed to follow agency infection control policies and procedures in 3 of 3 home visits. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Hand Hygiene Policy and Compliance Program”, revised July 2021, stated, “… Indications for staff performing hand hygiene are: Before and after direct patient care. Before and after each procedure. … After contact with contaminated materials. Before re-entering nursing bag or patient’s clean supplies...." 2. Review of an agency policy obtained 2/21/2022, titled “Standard Precautions” revised July 2021, stated, “… Perform hand hygiene after removing gloves….” 3. During an observation of care on 2/16/2022, at 9:55 AM, at the home of patient #1, start of care 9/4/2020, home health aide (HHA) C was observed washing the patient’s arms, chest, and back while wearing gloves. HHA C was observed removing gloves, placing gloves in the trash, and applying new gloves. HHA C was not observed performing hand hygiene after removing gloves. At 10:07 AM, HHA C was observed washing the patient’s buttocks and applying a barrier cream to the buttocks while wearing gloves. HHA was observed removing gloves, placing gloves in the trash, and applying new gloves. HHA C was not observed performing hand hygiene after gloves. 4. During an observation of care at the home of patient #2, start of care 7/16/2021, on 2/16/2022, at 11:23 AM, registered nurse (RN) D was observed spraying a liquid identified by RN D as normal saline on open area to the left buttock and 3 open areas to the right buttock while wearing gloves. RN D was observed wiping the open areas with a gauze pad and was observed spreading the skin on the buttock while wiping the open areas. An open area at 5 o’clock from the open area to the left buttock was observed to the inner left buttock. RN D was not observed changing gloves and performing hand hygiene after cleaning one wound and before cleaning another wound. At 11:25 AM, RN D was observed applying a gel from a bottle labeled “Anasept” to a white material RN D identified as alginate. RN D was observed applying the white material with the gel onto the middle right buttock open area and to the outer right buttock open area. RN D was observed covering the inner right buttock open area, the middle right buttock open area, and the outer right buttock open area with a foam dressing RN D identified as a mepilex dressing while wearing gloves. RN D was not observed changing gloves and performing hand hygiene after applying a treatment to one wound and before applying a treatment to another wound. At 11:28 AM, RN D was observed cleaning a brown, soft substance from the patient’s groin and perineal area (the area between the scrotum and the anus on a male) with a wipe while wearing gloves. RN D was observed getting a clean wipe and cleaning a plastic tube observed to be inserted into the penis. RN D was not observed changing gloves and performing hand hygiene after cleaning the brown substance from the patient’s groin and perineal area before cleaning the plastic tube inserted into the patient’s penis. RN D was observed using the same wipe to clean the plastic tube inserted into the penis to clean the opening of the penis where the plastic tube was inserted. RN D was observed wiping the groin area with a clean wipe and brown substance was observed on the wipe. RN D was observed rolling the wipes into the patient’s incontinent brief and reaching into a bag hanging on the patient’s doorknob observed to contain clean wound care supplies to grab a plastic bag. RN D was observed placing the used incontinent brief into the plastic bag. RN D was not observed to have removed gloves and performed hand hygiene after cleaning the patient’s penis, groin, and perineal area and removing the used brief from under the patient before reaching into the bag of clean wound care supplies. At 11:37 AM, RN D was observed removing a dry dressing from around a plastic tube inserted into the abdomen while wearing gloves. RN D was observed wiping around the area where the plastic tube was inserted into the abdomen with a clean gauze and applying a new dry dressing around the plastic tube inserted into the abdomen. RN D was observed removing gloves and applying new gloves and then observed assisting the patient to reposition in bed. RN D was not observed changing gloves and performing hand hygiene after removing old dressing from around the plastic tube inserted into the abdomen before applying the clean dressing, and RN D was not observed performing hand hygiene after removing old gloves and before applying new gloves. 5. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/21/2022 at 1:08 PM, physical therapist (PT) G was observed entering his bag and removing a gait belt, wipes, gloves, and an exercise bag. PT G was not observed to have performed hand hygiene before entering his bag to remove items. 6. During an interview on 2/18/2022, at 10:02 AM, the alternate administrator indicated staff should apply hand sanitizer or wash their hands after removing gloves and before applying new gloves. At 3:57 PM, the alternate administrator indicated staff should wash their hands prior to entering their bag to remove supplies and equipment. 7. During an interview on 2/21/2022, at 1:00 PM, the alternate administrator indicated the skilled nurse should change gloves and apply hand sanitizer after cleaning one wound and before cleaning another wound and after applying a treatment to a wound and before applying a treatment to another wound. At 1:01 PM, the alternate administrator indicated catheter care on a male should be completed by cleaning the tip of the penis and then cleaning the catheter tubing. The alternate administrator indicated the skilled nurse should have removed gloves and applied hand sanitizer after cleaning the patient’s perineal area and before reaching into a bag of clean wound care supplies. 17-12-1(m)

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 ensure staff was educated on infection control. The findings include: Review of an agency policy obtained 2/14/2022, titled “Infection Control Plan”, revised March 2018, stated, “… The Infection Control Plan … Establishes a training program upon employment which: Educates employees in the infection control program….” Review of an agency document titled” In-Service Training”, dated 6/11/2021, indicated the document was a sign-in sheet for staff in attendance for a training on basic infection control procedures. This document failed to evidence home health aide (HHA) E, physical therapist (PT) I, PT L, and medical social worker (MSW) T. During an interview on 2/18/2022, at 3:30 PM, the alternate administrator indicated all employees should be inserviced on infection control and was unsure why HHA E, PT I, PT L and MSW T were not provided infection control education. No further documents were provided.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop and implement policies and procedures to ensure all staff are fully vaccinated for COVID-19. The findings include: Review of an untitled binder on 2/14/2022 the alternate administrator identified as the infection program binder, evidenced an untitled, undated document which included the agency’s COVID-19 exposure response and the screening of patient and staff. Review failed to evidence policies and procedures which included a process for ensuring all staff are fully vaccinated for COVID-19, a process for ensuring the implementation of additional precautions for all staff who are not fully vaccinated for COVID-19, a process for tracking and documenting the COVID-19 vaccination status of staff, a process by which staff may request a COVID-19 vaccination exemption, a process for tracking and documenting information provided by staff requesting an exemption, and a contingency plan for staff who are not fully vaccinated for COVID-19. During an interview on 2/14/2022, at 1:05 PM, the alternate administrator indicated all of the agency’s policies regarding COVID-19 were in the binder identified as the infection control binder. Personnel record review on 2/15/2022 for the administrator, start date 6/1/2018, failed to evidence COVID-19 vaccination or a vaccine exemption. Personnel record review on 2/15/2022 for home health aide (HHA) E, start date 6/20/2019, failed to evidence COVID-19 vaccination or a vaccine exemption. Personnel record review on 2/15/2022 for office assistant P, start date unknown, failed to evidence COVID-19 vaccination or a vaccine exemption. Personnel record review on 2/15/2022 for occupational therapist (OT) Q, start date 2/5/2019, failed to evidence COVID-19 vaccination or a vaccine exemption. During an interview on 2/15/2022, at 12:27 PM, when queried where was the COVID-19 policy regarding employee vaccination, the alternate administrator stated, “There’s no mandate so we aren’t mandating that.” The alternate administrator indicated she thinks HHA E has a vaccine exemption but the agency did not have a copy of it. At 12:42 PM, the alternate administrator indicated office assistant P was getting an exemption but did not have it yet. The alternate administrator indicated the agency did not have a vaccine status for OT Q. The alternate administrator indicated the administrator had received the COVID-19 vaccine and indicated he had not submitted his vaccine card yet. The alternate administrator provided a document for review on 2/15/2022, at 12:45 PM, titled “Mandatory COVID-19 Vaccine Policy and Procedure”, dated 11/15/2021. During an interview on 2/15/2022, at 1:15 PM, the administrator indicated the document provided at 12:45 PM was sent to the agency by association D in the fall. The administrator stated, “As far as implementing it, no, we haven’t really done that. I just printed it. As the driving force, [the alternate administrator] and I aren’t very familiar with the policy.”

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); failed to prepare clinical notes (See tag G0716); failed to communicate with the physician and other health care practitioners (See tag G0718); failed to participate in the agency's quality assurance and performance improvement (QAPI) program (See tag G0720); failed to participate in agency-sponsored in-service training (See tag G0722) and failed to provide supervision of the home health aide (See tag G0724). 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.

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 observation, record review and interview, the physical therapist (PT) failed to develop the plan of care in 2 of 2 clinical records reviewed with PT services. (#3, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Rehabilitative Services” revised February 2021, stated, “… An individual rehabilitative care plan is developed with the patient/family. … Services provided will be planned to meet each patient’s individualized needs … Services provided by a physical or occupational therapist include: … Developing and revising the plan of care in consultation with the physician/practitioner and other care team members….” 2. During an observation of care at the home of patient #3, start of care 1/8/2022, on 2/18/2022, at 1:08 PM, PT G was observed obtaining the patient’s blood pressure, heart rate, and pulse oximetery (a non-invasive test that measures the saturation of oxygen in the blood). Clinical record review on 2/21/2022 evidenced an agency document titled “PT Evaluation”, electronically signed by PT I and dated 1/12/2022, and agency documents titled “PT Visit”, electronically signed by PT I and dated 1/18/2022, 1/19/2022, and 2/7/2022. These documents indicated the PT obtained vital signs to include blood pressure, heart rate, and respiration. Review evidenced an agency document titled “PT Plan of Care”, electronically signed by PT I and dated 1/12/2022, failed to evidence the PT was to obtain vital signs. 3. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced agency documents titled “PT Visit” electronically signed by PT L and dated 12/10/2021, 12/15/2021, 12/17/2021, 12/19/2021, 12/21/2021, and 12/29/2021, evidenced the PT obtained vital signs to include blood pressure, heart rate, respiration, temperature, and oxygen saturation. Review of an agency document titled “PT Plan of Care”, electronically signed and dated by PT L on 12/8/2021, failed to evidence the PT was to obtain vital signs. 4. During an interview on 2/21/2022, at 1:24 PM, the alternate administrator indicated the PT should have included obtaining vital signs in the PT plan of care. 17-14-1(b)(2)

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 skilled nurse failed to provide services as ordered by the physician in the plan of care in 6 of 7 clinical records reviewed (#1, #2, #3, #4, #5, #6) and in 1 of 2 clinical records reviewed receiving physical therapy services. (#7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Nursing Services” revised February 2021, stated, “… Professional nursing service will be provided by a registered nurse and include: … Initiating the plan of care and revising as necessary. Providing those services and/or treatments …. The Licensed Practical Nurse or Licensed Vocational Nurse (LPN/LVN) will supplement the nursing care needs of the patient as provided by the Registered Nurse ….” 2. Review of an agency policy obtained 2/21/2022, titled “Rehabilitative Services” revised February 2021, stated, “… Services provided will be planned to meet each patient’s individualized needs ….” 3. Clinical record review on 2/16/2022, for patient # 1, start of care 9/4/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022, which was signed by the physician on 1/23/2022. This document indicated the patient’s diagnoses included, but were not limited to, venous insufficiency (a condition which causes blood not to return properly to the heart resulting in blood pooling in the legs), chronic pain syndrome, unspecified disorder of the thyroid, calculus (a solid mass made of crystals) of kidney, dependence on supplemental oxygen, and chronic non-pressure ulcer to the left foot. This document indicated the skilled nurse was to teach the patient on signs and symptoms of vascular disease to include swelling of the legs and ankles, validate the caregiver’s ability for proper wound care management for the venous ulcer on the left great toe, teach the patient pain relief measures, teach the patient signs and symptoms related to the disorder of the thyroid, teach the patient signs and symptoms related to the calculus of the kidney, teach the patient on oxygen safety precautions, educate the patient on turning and repositioning every 2 hours, and educate the patient on methods to reduce friction and shear. Review of agency documents titled “SN [skilled nurse] Wound Care Visit”, dated 12/29/2021, 1/5/2022, 1/12/2022, 1/19/2022, 1/26/2022, and 2/9/2022, signed by registered nurse (RN) D, indicated the patient had pitting edema (excess fluid built up in the body and when pressure is applied, causes an indentation) at a degree of 2+ on a scale of 0 to 4+. Review of the documents indicated the patient rated the pain 4-5 on a scale of 0-10 with a pain frequency of daily. Review failed to evidence the RN educated the patient on signs and symptoms of vascular disease to include swelling of the legs and ankles, validated the caregiver’s ability for proper wound care management for the venous ulcer on the left great toes, educated the patient on signs and symptoms related to the disorder of the thyroid, educated the patient on signs and symptoms related to the calculus of the kidney, educated the patient on oxygen safety precautions, educated the patient on turning and repositioning every 2 hours, and educated the patient on methods to reduce friction and shear. Review failed to evidence the skilled nurse provided education on pain relief measures after the visit on 12/29/2021. During an interview on 2/18/2022, at 11:51 AM, the alternate administrator indicated the skilled nurse should have educated the patient on pain relief measures and wound care at every visit. 4. Clinical record review on 2/17/2022 and 2/21/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, which was signed by the physician on 2/4/2022. This document evidenced the patient’s diagnoses included, but were not limited to, gastrostomy (a tube surgically inserted into the stomach through the abdomen used to administer nutrition, fluid, and/or medication) and pressure ulcers (wound to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (an open pressure ulcer with partial thickness loss of skin) to the right and left buttocks. This document indicated the skilled nurse was to provide stoma (an opening in the body) care at the gastrostomy site and perform a skilled assessment of all body systems including the integumentary system (the system of the body pertaining to the skin, hair, and nails). This document indicated the patient had a foley catheter (an indwelling plastic tube inserted into the bladder to drain urine), which the skilled nurse was to change monthly. The plan of care indicated the skilled nurse was to change the foley catheter drainage bag every 2 weeks. This document indicated the skilled nurse was to notify the physician of a diastolic blood pressure (the pressure against the wall of the arteries when the heart is at rest, indicated by the bottom number of the blood pressure reading) of less than 60. During an observation of care at the patient’s home on 2/16/2022, at 10:58 AM, RN D was observed placing the blood pressure cuff on the patient’s right wrist. RN D indicated the patient’s blood pressure was 118/53. RN D was not observed notifying the physician of a diastolic blood pressure less than 60. Review evidenced agency documents titled “SN Wound Care Visit”, signed by RN D. Document dated 2/16/2022, indicated the patient’s blood pressure was 118/53. This document failed to evidence RN D notified the physician of the diastolic blood pressure less than 60. Documents dated 1/12/2022, 1/18/2022, 1/26/2022, and 2/9/2022, failed to evidence the RN provided gastrostomy care as directed in the plan of care. These documents failed to evidence the RN performed a wound assessment which included the depth of the wounds to the right and left buttocks. During an interview on 2/18/2022, at 12:21 PM, the alternate administrator indicated the RN should have completed gastrostomy since it was on the plan of care as a skilled nurse intervention. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, signed and dated by RN D on 1/7/2022, evidenced the foley catheter was last changed on 12/7/2021. Review of an agency document titled “SN Wound Care Visit”, dated and signed by RN D on 1/26/2022, evidenced the RN changed the patient’s foley catheter. Review failed to evidence the foley catheter was changed within a month and failed to evidence the drainage bag was changed every 2 weeks as directed by the plan of care. During an interview on 2/18/2022, at 12:26 PM, the alternate administrator indicated the RN should have changed the foley catheter before 1/7/2022 or before 30 days from the last catheter change. At 12:27 PM, the alternate administrator indicated she did not see the RN had changed the catheter bag as directed by the plan of care. 5. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/8/2022 – 3/8/2022, which was signed by the physician on 2/4/2022. Review indicated the patient’s diagnoses included, but were not limited to, malignant neoplasm (abnormal mass of tissue) of the prostate and bone and indicated the skilled nurse was to educate on the signs and symptoms of potential complications of the malignant neoplasm to the bone and prostate. This document indicated the patient had a pressure ulcer stage III (an open pressure ulcer with full thickness loss of skin) the left buttock, a pressure ulcer stage III to the right buttock, and a pressure ulcer stage III to the left heel. This document skilled nursing services 1 time a week for 2 weeks and 2 times a week for 7 weeks to include a skilled assessment of all body systems including the integumentary system. Review indicated the skilled nurse was to educate the patient on the signs of symptoms of potential complications of the malignant neoplasm to the bone and prostate. Review indicated the skilled nurse was to weigh the patient weekly. Review of agency documents titled “SN Wound Care Visit” dated 1/14/2022, 1/17/2022, 1/20/2022, 1/25/2022, 1/27/2022, 1/31/2022, 2/4/2022, 2/8/2022, 2/10/2022, 2/14/2022, and electronically signed by licensed practical nurse (LPN) H, failed to evidence the LPN performed a wound assessment which included the depth of the wounds to the right buttock, left buttock, and the left heel. Review of these documents failed to evidence the LPN educated the patient on the signs of symptoms of potential complications of the malignant neoplasm to the bone and prostate as directed in the plan of care. Review failed to evidence the patient was weighed after 1/8/2022 as directed in the plan of care. During an interview on 2/21/2022, at 2:07 PM, the alternate administrator indicated she did not see the skilled nurse weighed the patient. 6. Clinical record review on 2/17/2022, for patient #4, start of care 10/1/2020, evidenced agency documents titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed by the physician on 12/16/2021. This document indicated the patient’s diagnoses included polyosteoarthritis (degeneration of cartilage causing pain and swelling of the joints) and gastro-esophageal reflux disease (GERD, the back flow of stomach acid). This document indicated skilled nursing services were to be provided 1 time a week for 9 weeks and indicated the skilled nurse was to educate the patient on signs and symptoms and disease process of polyosteoarthritis and educate the patient on signs and symptoms of GERD. Review of agency documents titled “SN Teaching/Training Visit”, dated 12/1/2021, 12/08/2021, 12/15/2021, 12/23/2021, 12/28/2021, and 1/12/2021, electronically signed by LPN J, failed to evidence the LPN educated the patient on the signs and symptoms of polyosteoarthritis and GERD as directed in the plan of care. During an interview on 2/17/2022 at 3:58 PM, the alternate administrator indicated the skilled nurse should educate the patient on polyosteoarthritis and GERD since it was on the plan of care. Review on 2/21/2022, of an agency document titled “Home Health Certification and Plan of Care” for certification period 2/2/2022 – 4/2/2022, electronically signed by the alternate administrator and dated 2/2/2022, evidenced the skilled nurse was to obtain the patient’s weight weekly. Review of agency documents titled “SN Teaching/Training Visit”, electronically signed by LPN J and dated 2/9/2022, failed to evidence the skilled nurse obtained the patient’s weight. Review failed to evidence the patient’s weight was obtained since 2/2/2022 as directed in the plan of care. During an interview on 2/21/2022, at 2:35 PM, the alternate administrator indicated the nurse should have obtained the patient’s weight and was unsure why it was not completed. 7. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 9/13/2021 – 11/11/2022, signed and dated by the physician on 10/6/2021. Review indicated the patient’s diagnoses included, but were not limited to, major depressive disorder, generalized anxiety disorder, and GERD. This document indicated skilled nursing services were to be provided 1 time a week for 9 weeks and indicated the skilled nurse was to educate the patient on altered mental/emotional status, signs and symptoms of GERD, and energy conservation techniques. This document indicated the skilled nurse was to weigh patient weekly. Review of agency documents titled “SN Teaching/Training Visit”, electronically signed by LPN K and dated 9/14/2021 and 9/21/2021, and electronically signed by LPN J and dated 10/6/2021, 10/13/2021, 10/20/2021, and 10/27/2021, failed to evidence the skilled nurse educated the patient on altered mental/emotional status, signs and symptoms of GERD, and energy conservation techniques as directed in the plan of care. Documents dated 10/6/2021, 10/13/2021, 10/20/2021, and 10/27/2021, failed to evidence the patient was weighed weekly as directed in the plan of care. During an interview on 2/18/2022, at 4:22 PM, the alternate administrator indicated the skilled nurse did not weigh the patient weekly. 8. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed and dated by the physician on 12/16/2021. This document indicated the patient’s diagnoses included, but were not limited to, COPD (chronic obstructive pulmonary disease, a lung disease causing difficulty breathing), hemorrhoids, diabetes, and gout (a form of arthritis causing severe pain, redness, and swelling). This document indicated the skilled nurse was to notify the physician for systolic blood pressure (the pressure against the arteries when the heart contracts, indicated by the top number in the blood pressure reading) greater than 160. This document indicated the skilled nurse was to educate the patient on the signs and symptoms of COPD, educate on the management of hemorrhoids, educate on pain relief, educate on the management of gout, educate on the signs and symptoms of hyperglycemia and hypoglycemia, and educate on edema (swelling) of the legs. Review evidenced agency documents titled “SN Teaching/Training Visit”, electronically signed by RN D. Review of document dated 1/10/2022, indicated the patient’s systolic blood pressure was 162. Review failed to evidence the RN notified the physician of the systolic blood pressure greater than 160 as directed in the plan of care. Review of documents dated 12/2/2021, 12/9/2021, 12/23/2021, 12/30/2021, 1/3/2022, and 1/20/2022, indicated the patient’s pain was rated 5 on a scale of 0-10. These documents indicated the patient had rectal bleeding from hemorrhoids. These documents failed to evidence the RN educated the patient on the management of hemorrhoids, the signs and symptoms of COPD, pain relief, the management of gout, and the signs and symptoms of hyper and hypoglycemia as directed in the plan of care. These documents indicated the patient had 1+ pitting edema to the legs and failed to evidence the RN provided education on edema as directed in the plan of care on documents dated 12/9/2021, 12/23/2021, 12/30/2021, 1/3/2022, and 1/20/2022. During an interview on 2/18/2022, at 10:44 AM, the alternate administrator indicated the RN should have notified the physician of the blood pressure. At 10:56 AM, the alternate administrator indicated the RN should have provided education on hemorrhoids to include the use of any medications to treat hemorrhoids, increasing fluid and fiber intake. The alternate administrator indicated the RN should have educated the patient on pain relief to include repositioning and not waiting until pain gets worse before taking pain medications. The alternate administrator indicated the RN should have educated the patient on edema to include elevating the feet and reducing the intake of salt in the diet. 9. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “PT [physical therapy] Plan of Care”, electronically signed and dated by PT L on 12/8/2021. This document indicated the PT would provide services 2 times a week for 4 weeks and indicated the treatment plan included functional mobility training. Review of agency documents titled “PT Visit”, electronically signed by PT L and dated 12/10/2021, 12/15/2021, 12/17/2021, 12/19/2021, 12/21/2021, and 12/29/2021, failed to evidence the PT provided functional mobility training as directed in the plan of care. During an interview on 2/18/2022, at 11:12 AM, the alternate administrator indicated the PT did not document functional mobility training was provided. 10. During an interview on 2/18/2022, at 12:12 PM, the alternate administrator indicated the assessment of wounds should include length and width and should include depth if the wound is open. 11. During an interview on 2/21/2022, at 1:56 PM, the alternate administrator indicated the skilled nurse should educate the patient per the plan of care. 17-14-1(a)(1)(H) 17-14-1(a)(2)(F)

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the licensed practical nurse (LPN) failed to educate the patient and caregiver on swelling and wound prevention measures in 2 of 3 active clinical records reviewed with services provided by a LPN. (#3, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Nursing Services” revised February 2021, stated, “… Professional nursing service will be provided by a registered nurse [RN] and include: … Counseling and educating the patient and family regarding the disease process, self-care techniques and prevention strategies. … The Licensed Practical Nurse or Licensed Vocational Nurse (LPN/LVN) will supplement the nursing care needs of the patient as provided by the Registered Nurse ….” 2. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Start of Care”, electronically signed by RN F and dated 1/8/2022. This document indicated the patient’s diagnoses included, but were not limited to, diabetes (a chronic condition which affects the way the body processes blood sugar). This document indicated the patient had a history of falls, was at risk for falls, was at risk for skin breakdown, had poor balance, and had a shuffling gait. This document indicated the patient was up as tolerated with the use of a walker. Review evidenced agency documents titled “SN [skilled nurse] Wound Care Visit” electronically signed by LPN H. Review of the documents dated 2/8/2022, 2/10/2022, and 2/14/2022, indicated the patient had pitting edema (excess fluid built up in the body and when pressure is applied, causes an indentation) at a degree of 2+ on a scale of 0 to 4+. Review of the document dated 2/10/2022, evidenced the LPN assessed skin tear wounds to the left lower extremity. Review of these documents failed to evidence the LPN educated the patient and caregiver on the pitting edema and the prevention of skin tears. During an observation of care at the home on 2/18/2022, at 1:15 PM, the patient was observed to have swollen lower extremities between the knees and ankles. The patient was observed to have 20+ scabbed areas on the left shin and 8 scabbed areas on the right shin. No dressing was noted to the patient’s scabbed areas. During an interview at the patient’s home on 2/18/2022, at 1:15 PM, the patient’s caregiver indicated the patient had neuropathy (damage to the nerves most often to the hands and feet and a common symptom of diabetes) and has fallen over a dozen times to include the most recent fall 3 weeks ago. The patient’s caregiver indicated the patient gets cuts on his legs from falling or bumping his legs on things. The patient’s caregiver indicated the patient’s legs weep (severe swelling that causes fluid to leak from the skin) from the swelling. During an interview on 2/21/2022, at 1:58 PM, the alternate administrator indicated there was not documentation the LPN educated the patient/caregiver on the prevention of skin tears and indicated the LPN should have educated the patient to wear clothing or padding to protect the areas. At 2:03 PM, the alternate administrator indicated the LPN did not document the education to the patient/caregiver related to the patient’s onset of pitting edema. The alternate administrator indicated education should include elevating the lower extremities. 3. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by LPN K and dated 9/21/2021. This document indicated the patient had eye lid surgery on 9/16/2021 and the eye had 9 sutures. Review indicated the nurse assessed a surgical wound to the right lateral eye with an incision to include 9 intact sutures with an onset date of 9/16/2021. This document indicated the nurse cleaned the surgical wound with normal saline and left open to air. Review failed to evidence the LPN provided the patient and caregiver education regarding the wound care to the right eye. During an interview on 2/18/2022, at 4:21 PM, the alternate administrator indicated there was not documented education provided by the LPN regarding the surgical wound to the right eye and indicated the LPN should have reviewed the wound care with the patient and caregiver. 17-14-1(a)(2)(E)

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the skilled nurse failed to accurately prepare clinical notes in 2 of 7 clinical records reviewed (#2, #5), and the physical therapist failed to accurately prepare clinical notes in 1 of 2 clinical records reviewed with physical therapy services. (#7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Nursing Services” revised February 2021, stated, “… Professional nursing service will be provided by a registered nurse and include: … Preparing clinical and progress notes … The Licensed Practical Nurse or Licensed Vocational Nurse (LPN/LVN) will supplement the nursing care needs of the patient as provided by the Registered Nurse….” 2. Review of an agency policy obtained 2/21/2022, titled “Rehabilitative Services” revised February 2021, stated, “… Services provided by a physical or occupational therapist include: … Preparing clinical and progress notes….” 3. Clinical record review on 2/17/2022 and 2/21/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, signed and dated by registered nurse (RN) D on 1/7/2022. This document indicated the patient had 2 pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) stage II (an open pressure ulcer with partial thickness loss of skin), 1 located on the left buttock and 1 located on the right buttock. Review evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022. This document indicated the patient’s diagnoses included, but were not limited to, pressure ulcers (wound to the skin and underlying tissue resulting from prolonged pressure to the skin) to the right and left buttocks and diabetes (a chronic condition which affects the way the body processes blood sugar). The document indicated the skilled nurse was to clean the wound to the right buttock and the left buttock with normal saline (a solution used to clean wounds) and apply barrier ointment. Review evidenced agency documents titled “SN [skilled nurse] Wound Care Visit”, signed by RN D. Document dated 1/12/2022, evidenced the primary diagnosis was a pressure ulcer to the right heel. Documents dated 1/12/2022, 1/18/2022, 1/26/2022, 2/9/2022, 2/16/2022, and 2/28/2022 failed to evidence diabetes was checked under the assessment of the endocrine (the system in the body made up of the body’s hormones) section. During an interview on 2/18/2022, at 12:18 PM, the alternate administrator indicated the primary diagnosis on the skilled nurse visit note was incorrect and indicated the skilled nurse should check diabetes under the endocrine assessment. Review of an agency document titled “SN Wound Care Visit”, dated and electronically signed by RN D on 2/9/2022, evidenced two new pressure ulcers Stage II to the left lateral buttock. Review of an agency document titled “Physician Order”, electronically signed and dated by the alternate administrator on 2/9/2022, evidenced the 2 wounds to the left lateral buttocks were to be cleaned with normal saline, apply anasept gel (an antimicrobial wound gel) to the wound bed, apply calcium alginate (a highly absorptive wound dressing), and cover with mepilex (a foam dressing) 2 times a week. During an observation of care at the home of patient #2 on 2/16/2022, at 11:19 AM, the patient was observed lying on his right side with an uncovered, open area to the left buttock and an uncovered, open area to the right buttock. The patient was observed to have a transparent, adhesive dressing to the right buttock on the right side of the uncovered, open area to the right buttock. RN D indicated the uncovered, open area to the left buttock and the uncovered, open area to the right buttock were the original wounds. RN D was observed removing the transparent, adhesive dressing to the right buttock and 2 open areas were observed to the right of the uncovered, open area on the right buttock. At 11:23 AM, RN D was observed spraying a liquid identified by RN D as normal saline on open area to the left buttock and 3 open areas to the right buttock. RN D was observed wiping the open areas with a gauze pad and was observed spreading the skin on the buttock while wiping the open areas. An open area at 5 o’clock from the open area to the left buttock was observed to the inner left buttock. At 11: 25 AM, RN D was observed applying a gel from a bottle labeled “Anasept” to a white material RN D identified as alginate. RN D was observed applying the white material with the gel onto the middle right buttock open area and to the outer right buttock open area. RN D was observed covering the inner right buttock open area, the middle right buttock open area, and the outer right buttock open area with a foam dressing RN D identified as a mepilex dressing. RN D was not observed applying the barrier cream to the inner right buttock open area before covering with the foam dressing as ordered by the physician on the plan of care. RN D was observed applying a cream RN D identified as calmoseptine (a barrier ointment to protect the skin from moisture) to the open area on the left buttock and to the open area at 5 o’clock of the open area on the left buttock on the inner left buttock. At 11:55 AM, RN D exited the patient’s home, and RN D was not observed to have completed a medication reconciliation. Review of an agency document on 2/21/2022, titled “SN Wound Care Visit”, dated and electronically signed by RN D on 2/16/2022, indicated barrier ointment was applied to the right and left buttock wounds. This document indicated anasept gel, calcium alginate, and a mepilex dressing was applied to the two left lateral buttock wounds. This document failed to evidence the RN documented the anasept gel, calcium aginate, and mepilex dressing observed to be applied to the open area to the right inner buttock, the open area to the right middle buttock, and the open area to the right outer buttock. This document failed to evidence the RN documented the barrier cream observed to be applied to the left inner buttock. This document indicated the RN completed a medication reconciliation. During an interview on 2/21/2022, at 1:03 PM, the alternate administrator indicated RN D should have looked at the patient’s medication bottles and asked the family if there were any medication changes. At 1:13 PM, the alternate administrator indicated the RN should document the care that is provided and should document where the wound care was provided. 4. Clinical record review on 2/17/2022, for patient #5, start of care 2/2/2022, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by LPN J and dated 2/9/2022. This document indicated the patient had a fracture and a partial weight bearing restriction. Review of an unsigned agency document titled “OASIS-D1 Start of Care”, with a visit date of 2/2/2022, failed to evidence a fracture and a partial weight bearing restriction in the comprehensive assessment. During an interview on 2/18/2022, at 4:09 PM, the alternate administrator indicated the patient did have an old fracture but was unsure to what part of the body. The alternate administrator indicated the partial weight restriction was not current and the LPN documented the visit note incorrectly. 5. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 11/19/2021 – 1/17/2022. This document indicated the patient’s diagnoses included, but were not limited to, dementia, and fracture of the left femur (the long bone in the upper leg). Review of an agency document titled “PT [physical therapy] Plan of Care”, electronically signed by PT L and dated 12/8/2021, evidenced the patient’s medical diagnosis was hip fracture. Review failed to evidence the PT accurately prepared the PT document. During an interview on 2/18/2021, at 11:10 AM, the alternate administrator indicated she was unsure why the PT documented the patient’s medical diagnosis was hip fracture and indicated the diagnosis should be the same as the diagnosis on the agency’s plan of care. 17-14-1(a)(1)(E) 17-14-1(a)(2)(B) 17-14-1(c)(5)

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 observation, record review and interview, the licensed practical nurse (LPN) failed to communicate with the physician with a patient’s change in status in 2 of 3 active clinical records reviewed with services provided by a LPN. (#3, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Nursing Services” revised February 2021, stated, “… Professional nursing service will be provided by a registered nurse [RN] and include: … Informing the physician/practitioner and other staff of changes in the patient’s needs … The Licensed Practical Nurse or Licensed Vocational Nurse (LPN/LVN) will supplement the nursing care needs of the patient as provided by the Registered Nurse ….” 2. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Start of Care”, electronically signed by RN F and dated 1/8/2022. This document indicated the patient’s diagnoses included, but were not limited to, diabetes (a chronic condition which affects the way the body processes blood sugar). This document failed to evidence the patient had pitting edema (excess fluid built up in the body and when pressure is applied, causes an indentation). Review evidenced agency documents titled “SN [skilled nurse] Wound Care Visit” electronically signed by LPN H. Review of the documents dated 2/8/2022, 2/10/2022, and 2/14/2022, indicated the patient had pitting edema at a degree of 2+ on a scale of 0 to 4+. Review of these documents failed to evidence the LPN notified the physician regarding the pitting edema. During an observation of care at the home on 2/18/2022, at 1:15 PM, the patient was observed to have swollen lower extremities between the knees and ankles. During an interview at the patient’s home on 2/18/2022, at 1:15 PM, the patient’s caregiver indicated the patient’s legs weep (severe swelling that causes fluid to leak from the skin) from the swelling. During an interview on 2/21/2022, at 2:03 PM, the alternate administrator indicated the physician was not notified of the swelling and indicated the LPN should have informed the physician. 3. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by LPN K and dated 9/21/2021. This document indicated the patient had eye lid surgery on 9/16/2021 and the eye had 9 sutures. Review indicated the nurse assessed a surgical wound to the right lateral eye with an incision to include 9 intact sutures with an onset date of 9/16/2021. This document indicated the nurse cleaned the surgical wound with normal saline and left open to air. Review failed to evidence the LPN contacted the patient’s primary physician regarding the surgical wound and wound treatment to the right eye. During an interview on 2/18/2022, at 4:13 PM, the alternate administrator indicated the patient’s primary physician was not the physician who performed the eye surgery and indicated the primary physician was contacted regarding the right eye surgery and wound treatment performed. 17-14-1(a)(2)(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, the agency failed to ensure skilled professionals participated in the agency’s quality assurance performance improvement (QAPI) program. The findings include: Review of an agency policy obtained 2/21/2022, titled “Skilled Professional Services” stated, “… Skilled professionals must assume responsibility for … Participation in the Agency’s QAPI program….” Review of an untitled agency document titled with an effective date of 2/15/2022, evidenced registered nurse (RN) D provided skilled nursing services to patient #1, start date 9/4/2020. This document evidenced licensed practical nurse (LPN) H and physical therapist (PT) provided skilled nursing services to patient #3, start date 1/8/2022. Review of the agency’s QAPI binder on 2/16/2022, failed to evidence the involvement of therapists in the QAPI program. During an interview on 2/16/2022 at 1:48 PM, the administrator indicated he and the alternate administrator were involved in QAPI. The administrator indicated no other skilled nurses than the alternate administrator was involved with QAPI and indicated therapists and social worker were not involved with QAPI. The administrator stated, “Maybe their insight would be helpful.”

Supervise skilled professional assistants CFR(s): 484.75(c) Standard: Supervision of skilled professional assistants. This STANDARD is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to provide supervision of the licensed practical nurse (LPN) in 3 of 3 active clinical records reviewed with services provided by a licensed practical nurse. (#3, #4, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Nursing Services” revised February 2021, stated, “… Professional nursing service will be provided by a registered nurse and include: … Supervising LVN (licensed vocational nurse)/LPNs ….” 2. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/8/2022 – 3/8/2022, which was signed by the physician on 2/4/2022. This document indicated the patient had a pressure ulcer (wound to the skin and underlying tissue resulting from prolonged pressure to the skin) stage III (an open pressure ulcer with full thickness loss of skin) the left buttock, a pressure ulcer stage III to the right buttock, and a pressure ulcer stage III to the left heel. This document skilled nursing services 1 time a week for 2 weeks and 2 times a week for 7 weeks to include a skilled assessment of all body systems including the integumentary system. Review of agency documents titled “SN [skilled nurse] Wound Care Visit” dated 1/14/2022, 1/17/2022, 1/20/2022, 1/25/2022, 1/27/2022, 1/31/2022, 2/4/2022, 2/8/2022, 2/10/2022, 2/14/2022, and electronically signed by licensed practical nurse LPN H, failed to evidence the LPN performed a wound assessment which included the depth of the wounds to the right buttock, left buttock, and the left heel. Review of an agency document titled “LVN Supervisory Visit”, electronically signed by the alternate administrator and dated 2/8/2022, indicated the LPN followed the patient’s plan of care for completion of tasks as assigned. Review failed to evidence the registered nurse provided LPN supervision to ensure the LPN followed the plan of care as directed. During an interview on 1/21/2022, at 1:43 PM, the alternate administrator indicated the RN should have followed up with the LPN to inform her the assessment of depth of the wounds should be obtained. The alternate administrator indicated not all of the skilled nurse visit notes are reviewed by a RN and indicated the RN conducts the LPN supervisory visits by talking to the patient and not with the staff. 3. Clinical record review on 2/17/2022, for patient #4, start of care 10/1/2020, evidenced agency documents titled “Home Health Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022, which was signed by the physician on 12/16/2021. This document indicated the patient’s diagnoses included polyosteoarthritis (degeneration of cartilage causing pain and swelling of the joints) and gastro-esophageal reflux disease (GERD, the back flow of stomach acid). This document indicated skilled nursing services were to be provided 1 time a week for 9 weeks and indicated the skilled nurse was to educate the patient on signs and symptoms and disease process of polyosteoarthritis and educate the patient on signs and symptoms of GERD. Review of agency documents titled “SN Teaching/Training Visit”, dated 12/1/2021, 12/08/2021, 12/15/2021, 12/23/2021, 12/28/2021, and 1/12/2021, electronically signed by LPN J, failed to evidence the LPN educated the patient on the signs and symptoms of polyosteoarthritis and GERD as directed in the plan of care. Review of an agency document titled “LVN Supervisory Visit”, electronically signed by the alternate administrator and dated 12/30/2021, indicated the LPN followed the patient’s plan of care for completion of tasks as assigned. Review failed to evidence the registered nurse provided LPN supervision to ensure the LPN followed the plan of care as directed. During an interview on 2/17/2022, at 3:56 PM, the alternate administrator indicated the LPN did not follow the plan of care, the RN does not review all of the LPN’s notes, and conducts the supervisory visit over the phone with the patient and not with the staff. 4. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “SN Teaching/Training Visit”, electronically signed by LPN K and dated 9/21/2021. This document indicated the patient had eye lid surgery on 9/16/2021 and the eye had 9 sutures. Review indicated the nurse assessed a surgical wound to the right lateral eye with an incision to include 9 intact sutures with an onset date of 9/16/2021. This document indicated the nurse cleaned the surgical wound with normal saline and left open to air. Review of an agency document titled “Home Health Certification and Plan of Care” for certification period 9/13/2021 – 11/11/2021, failed to evidence the plan of care included the surgical wound and treatment to the right eye. Review failed to evidence a physician’s order for the treatment to the right eye surgical wound for the cleaning of the wound. Review of agency documents titled “LVN Supervisory Visit”, electronically signed by the alternate administrator and dated 9/30/2021, 10/29/2021 and 11/8/2021, indicated the LPN followed the patient’s plan of care for completion of tasks as assigned. Review failed to evidence the registered nurse provided LPN supervision to ensure the LPN provided care as directed by the plan of care. During an interview on 2/18/2022, at 4:14 PM, the alternate administrator indicated the RN should have not marked the LPN was providing care as directed by the plan of care since there was not an order for the wound treatment provided to the right eye.

Home health aide services CFR(s): 484.80 Condition of participation: Home health aide services. All home health aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure: all home health aide care plans were completed and contained frequency of tasks to be performed (See tag G0798); all home health aides followed the aide care plan tasks developed by the skilled professional (See tag G0800); all home health aides reported changes in the patient’s condition to a registered nurse or other appropriate skilled professional (See tag G0804); and all home health aide supervisory visits conducted ensured the home health aide was following the aide care plan (See tag G0818). 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 484.80 Home Health Aide Services.

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 observation, 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 4 of 4 clinical records reviewed with home health aide services. (#1, #2, #3, #6) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Care Planning Process” revised February 2021, stated, “… The patient care plan for the Home Health Aide [HHA] will be: Home Health Aide assignment sheet: developed by a Registered Nurse … prior to Home Health Aide rendering care … and based on patient’s health status and environment. … The assignment sheet/plan of care will include: Diagnosis … Functional limitation … Activities permitted. Nutritional requirements. Specific procedure to be performed ….” 2. Clinical record review on 2/16/2022, for patient #1, start of care 9/4/2020, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 12/28/2021 – 2/25/2022. This document indicated the patient was receiving oxygen as needed and indicated oxygen precautions were included in the patient’s safety precautions. Review of an agency document titled “HHA Care Plan”, signed and dated by registered nurse (RN) D on 12/23/2021, failed to include oxygen precautions in the patient’s safety precautions. During an interview on 2/18/2022, at 11:43 AM, the alternate administrator indicated oxygen precautions should be included in the home health aide care plan. 3. During an observation of care on 2/16/2022, at 10:58 AM, at the home of patient #2, start of care 7/16/2021, an oxygen concentrator (a medical device for oxygen therapy) and an oxygen tank were observed in the corner of the patient’s bedroom. Clinical record review on 2/17/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022. This document evidenced the patient’s diagnoses included, but were not limited to, pressure ulcers (wounds to the skin and underlying tissue resulting from prolonged pressure to the skin) to the left and right buttocks. This document indicated the patient was NPO (nothing by mouth) and had a gastrostomy (a tube surgically inserted into the stomach through the abdomen used to deliver nutrition, fluids, and/or medication). This document indicated the patient was bedbound and unable to sit in a chair. This document indicated the patient was on complete bedrest. Review of an agency document titled “HHA Care Plan”, signed and dated by RN D on 1/7/2022, indicated the patient’s primary diagnosis was a pressure ulcer to the right heel. This document failed to evidence oxygen precautions were noted. This document indicated the patient’s diet was heart healthy and failed to evidence aspiration (when food, fluid or another substance enters the airway or lungs accidentally, may occur when there is difficulty with swallowing) precautions were noted. This document indicated the HHA was assigned to assist with ambulation and indicated the patient’s permitted activities included sitting in the wheelchair and complete bedrest. Review failed to evidence the RN provided the HHA patient-specific information on the HHA care plan related to the patient’s diagnosis, diet, mobility, and safety precautions. During an interview on 2/18/2022, at 12:15 PM, the alternate administrator indicated the patient used to have a wound to the right heel and indicated the care plan should have reflected the current diagnosis. At 12:16 PM, the alternate administrator indicated the oxygen precautions should have been included on the HHA care plan. At 12:17 PM, the alternate administrator indicated aspiration precautions and NPO status should have been included on the HHA care plan. At 12:18 PM, the alternate administrator indicated the activities permitted on the HHA care plan were inconsistent with both wheelchair and complete bedrest marked. The alternate administrator indicated the RN should not have assigned the HHA to assist with ambulation since the patient does not get out of bed. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/8/2022 – 3/8/2022. This document indicated the patient’s medications included, but were not limited to, Plavix (a blood thinning medication used to prevent heart attacks and strokes) and Aspirin (a blood thinning medication used to prevent heart attacks and strokes). The plan of care included anticoagulant precautions (safety measures to reduce the risk of bleeding) in the patient’s safety measures. Review of an agency document titled “HHA Care Plan”, electronically signed and dated by RN F on 1/8/2022, failed to include anticoagulant precautions. This document indicated the HHA was to obtain the patient’s vital signs at every visit, to include temperature, heart rate, blood pressure, and respirations. During an interview on 2/21/2022, at 1:15 PM, the alternate administrator indicated the RN should have included anticoagulant precautions in the HHA care plan. The alternate administrator indicated the agency does not have the HHA obtain vital signs and indicated the RN should not have assigned this task to the HHA on the HHA care plan. 5. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “Home Heath Certification and Plan of Care” for certification period 11/25/2021 – 1/23/2022. This document indicated the patient’s medications included, but were not limited to, Asprin, and indicated the patient’s safety measures included bleeding precautions. Review of an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Recertification”, electronically signed and dated by RN D on 11/22/2021, indicated the patient had urinary incontinence (loss of bladder control). Review of an agency document titled “HHA Care Plan”, electronically signed and dated by RN D on 11/22/2021, failed to evidence bleeding precautions were included in the patient’s safety measures. This document failed to evidence the functional limitations included urinary incontinence. During an interview on 2/18/2022, at 10:49 AM, the alternate administrator indicated the bleeding precautions should have been included on the HHA care plan. The alternate administrator indicated the functional limitations on the HHA care plan should have included urinary incontinence. 17-14-1(m)

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 by the physician, included in the plan of care, and consistent with the aide care plan in 3 of 3 active clinical records reviewed with home health aide services. (#1, #2, #3) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Home Health Aide Documentation” revised March 2018, stated, “… The HHA [home health aide] will document services rendered to the patient on the appropriate Home Health Aide charting form as directed in the Aide care plan/assignment sheet….” 2. Clinical record review on 2/16/2022, for patient #1, start of care 9/4/2020, evidenced an agency document titled “HHA Care Plan”, signed and dated by the registered nurse on 12/23/2021, failed to evidence the HHA was assigned to provide oral care. This document indicated the HHA was to assist the patient with a shower with a chair, assist the patient with a shower with a chair, provide nail care, and perform range of motion exercises at every visit. Review failed to evidence lotions or creams that were to be applied by the HHA to the patient. During an observation of care at the patient’s home on 2/16/2022, at 9:50 AM, HHA C was observed assisting the patient with a sponge bath while the patient sat on the toilet. At 10:12 AM, HHA C was observed handing the patient a cup. The patient was observed sipping from the cup and swishing fluid around in her mouth. HHA C was observed handing the patient another cup and the patient was observed spitting the fluid in her mouth into the cup. HHA C was observed handing the patient a cup which contained dentures. The patient was observed placing upper and lower full dentures into her mouth. At 9:59 PM, HHA C was observed applying lotion from a bottle labeled “Ammonium Lactate” (a topical medication used to treat dry, scaly skin conditions) to the patient’s legs. At 10:07 AM, HHA C was observed applying cream to the patient’s buttocks HHA C identified as barrier cream. The home health aide was not observed to have provided the patient with a shampoo, nail care and range of motion exercises. Review of an agency document titled “HHA Visit”, dated 2/16/2022 and electronically signed by HHA C, failed to indicate HHA C documented the oral care assistance provided to the patient. During an interview on 2/18/2022, at 11:39 AM, the alternate administrator indicated rinsing the mouth was considered oral care. At 11:52 AM, the alternate administrator indicated at some point the care changed to bathing the patient on the toilet rather than in the shower. At 12:00 PM, the alternate administrator indicated the HHA should not apply creams unless directed to do so on the HHA care plan. 3. Clinical record review on 2/17/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/12/2022 – 3/12/2022, and signed by the physician on 2/4/2022. This document indicated the patient was bedbound and unable to sit in a chair. This document indicated the patient was on complete bedrest. Review evidenced agency documents titled “HHA Visit”, dated 1/12/2022, 1/14/2022, 1/17/2022, 1/19/2022, 1/21/2022, 1/24/2022, 1/26/2022, 1/28/2022, 1/31/2022, 2/2/2022, 2/4/2022, 2/7/2022, 2/9/2022, 2/11/2022, and 2/14/2022, and signed by HHA E. These documents indicated the HHA assisted the patient with ambulation and failed to evidence the HHA completed tasks as ordered by the physician. During an interview on 2/21/2022, at 1:06 PM, the alternate administrator indicated the HHA does not ambulate the patient but documented she did on the HHA visit notes since assist with ambulation was on the home health aide care plan as an assigned task. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “HHA Care Plan”, electronically signed and dated by RN F on 1/8/2022. This document indicated the HHA was to obtain vital signs to include temperature, blood pressure, heart rate and respiration every visit. This document indicated the HHA was to provide a shower with a chair every visit. The document evidenced the bed bath, assist with chair bath, assist with bedpan/urinal, and assist with the bedside commode were not applicable. Review of agency documents titled “HHA Visit”, electronically signed by HHA E indicated the HHA documented the HHA provided a bed bath, assisted with a chair bath, and failed to obtain vital signs on 1/13/2022, 1/15/2022, 1/18/2022, 1/27/2022, 2/4/2022, and 2/10/2022. These documents indicated the HHA assisted the patient with the bedpan/urinal on 1/13/2022, 1/15/2022, 1/18/2022, 1/27/2022, 2/4/2022, and 2/10/2022. The document dated 1/15/2022 indicated the HHA assisted with the patient with the bedside commode. Review failed to evidence the HHA provided care as directed by the HHA care plan. 5. During an interview on 2/18/2022, at 12:07 PM, the alternate administrator indicated the HHA should perform the care as directed on the HHA care plan. 6. During an interview on 2/21/2022, at 1:08 PM, the alternate administrator indicated the HHA should document the care provided to the patient.

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 failed to report changes in the patient’s condition to a registered nurse or other appropriate skilled professional in 1 of 1 home visits with the home health aide. (#1) The findings include: Review of an agency policy obtained 2/21/2022, titled “Home Health Aide Documentation” revised March 2018, stated, “… The HHA [home health aide] will be responsible for reporting any changes in the patient’s condition and/or other pertinent observations to the supervising RN [registered nurse]/Therapist….” During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 9:59 AM, home health aide (HHA) C was observed assisting the patient with a sponge bath while the patient sat on the toilet. The patient was observed to have a dry dressing on the right knee. The patient indicated it was a rash and complained of itching to the area. The HHA was not observed reporting the dry dressing, the rash, and the patient’s complaint of itching to the RN. Clinical record review on 2/18/2022 failed to evidence documentation of a rash and an order for a dry dressing to the patient’s right knee. Review on 2/21/2022, evidenced an agency document titled “HHA Visit”, dated 2/16/2022 and electronically signed by HHA C. Review failed to evidence the HHA reported the dressing to the right knee, the rash, and the patient’s complaint of itching to the supervising RN. During an interview on 2/21/2022, at 1:09 PM, the alternate administrator indicated there was no documentation the home health aide reported the dry dressing and rash to the RN and indicated the home health aide should have reported it to the RN.

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 record review and interview, the agency failed to ensure the home health aide (HHA) was supervised to ensure the aides furnished care that followed the patient’s plan of care in 1 of 3 active clinical records reviewed with home health aide services. (#3) The findings include: Review of an agency policy obtained 2/21/2022, titled “Home Health Aide Supervision” revised February 2021, stated, “… Home Health Aide Supervision must ensure that aides furnish care in a safe and effective manner including, but not limited to, the following elements: Following the patient’s plan of care for completion of tasks assigned to a Home Health Aide by the registered nurse ….” Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “HHA Care Plan”, electronically signed and dated by RN F on 1/8/2022. This document indicated the HHA was to obtain vital signs to include temperature, blood pressure, heart rate and respiration every visit. This document indicated the HHA was to provide a shower with a chair every visit. The document evidenced the bed bath, assist with chair bath, assist with bedpan/urinal, and assist with the bedside commode were not applicable. Review of agency documents titled “HHA Visit”, electronically signed by HHA E indicated the HHA documented the HHA provided a bed bath, assisted with a chair bath, and failed to obtain vital signs on 1/13/2022, 1/15/2022, 1/18/2022, 1/27/2022, 2/4/2022, and 2/10/2022. These documents indicated the HHA assisted the patient with the bedpan/urinal on 1/13/2022, 1/15/2022, 1/18/2022, 1/27/2022, 2/4/2022, and 2/10/2022. The document dated 1/15/2022 indicated the HHA assisted with the patient with the bedside commode. Review failed to evidence the HHA provided care as directed by the HHA care plan. Review of an agency document titled “HHA Supervisory Visit”, electronically signed by the alternate administrator and dated 1/22/2022, indicated the HHA followed the patient’s plan of care for completion of tasks as assigned. 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 1/31/2022, at 1:31 PM, the alternate administrator indicated the supervisory visit should not be documented that the HHA is following the care plan and indicated the RN should follow-up with the HHA to review the care plan. 17-14-1(n)

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 be responsible for the day-to-day operations of the agency. The findings include: Review of an agency job description on 2/15/2022, titled “Administrator” revised March 2018, stated, “… The Administrator ensures quality and safe delivery of home health care services and responsible for all day-to-day operations of the Agency….” 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 the patients were provided the name of the administrator to receive complaints. Please see tag G0414. The administrator failed to ensure the patient was informed of and consented to care in advance of the frequency of visits and changes in the care to be furnished. Please see tag G0434. 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 patient was discharged because the physician responsible for the plan of care and the agency agree the measurable goals and outcomes set forth in the plan of care have been achieved. Please see tag G0458. The administrator failed to ensure the patient was discharged because the patient refused services. Please see tag G0460. The administrator failed to ensure a registered nurse (RN) conducted the initial assessment to determine the immediate care and support needs. Please see tag G0514. The administrator failed to ensure the comprehensive assessment reflected the patient’s current health status. Please see tag G0528. 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 comprehensive assessment was updated and revised to include new wounds. Please see tag G0544. 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 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. Please see tag G0584. 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 patient’s condition. Please see tag G0590. The administrator failed to ensure the plan of care was revised to reflect the patient’s current status. Please see tag G0592. The administrator failed to ensure revisions to the plans for patient discharge was communicated to the physician responsible for the plan of care. Please see tag G0598. 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 provide the patient and caregiver in writing with the treatments to be administered by agency personnel. Please see tag G0618. The administrator failed to provide the patient and caregiver in writing with the name and contact information of the clinical manager. Please see tag G0622. 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 the home health agency maintained and documented an infection control program. Please see tag G0680. The administrator failed to ensure the skilled professional developed the plan of care. Please see tag G0708. 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 the skilled professional provided education to the patient and caregiver. Please see tag G0714. The administrator failed to ensure skilled professionals created clinical notes and/or accurate complete notes for all services provided to patients. Please see tag G0716. The administrator failed to ensure skilled professionals communicated with the physician with a patient’s change in status. Please see tag G0718. 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 the skilled professional provided supervision of the licensed practical nurse (LPN). Please see tag G0724. 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. 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 all clinical records contained all required documentation of services rendered by agency staff. Please see tag G1012. The administrator failed to ensure all clinical records contained a discharge summary that was sent to the primary care physician. Please see tag G1022. The administrator failed to ensure all clinical notes were clear, complete and appropriately authenticated. Please see tag G1024. During an interview on 2/18/2022, at 9:00 AM, the alternate administrator, when queried about the role of the nurse consultant, stated “I take full responsibility for these things, but I relied on [person C, nurse consultant] to answer questions for me.” 17-12-(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 and influenza vaccination to agency personnel. The findings include: Review of an agency policy obtained 2/21/2022, titled “Medication Storage” revised March 2018, stated, “… If the Agency stores medications onsite in office, medications will be stored properly and safely. Medications will be stored under proper conditions to ensure stability, including: Storing at proper temperatures … and keeping temperature records….” During an interview on 2/16/2022, at 1:41 PM, the alternate administrator, who self-identifies as the clinical manager, indicated the agency provided TB skin tests and influenza vaccines and indicated the medication was stored in the office. During an observation on 2/16/2022, at 1:41 PM, a refrigerator was observed in the office. The thermometer inside of the refrigerator was observed to read 26 degrees Fahrenheit. A box labeled “Tubersol” (a medication used to administer TB skin tests) was observed on a shelf inside of the refrigerator. A vial labeled “Tubersol” inside of the box was observed to be open. No date of opening was observed on the vial or on the box of Tubersol. Observed on the box were storage guidelines from the manufacturer which indicated the medication should be stored between 35-46 degrees Fahrenheit. Observed on the box were guidelines by the manufacturer which indicated the medication should be discarded 30 days after opening. A box labeled “Flucelvax Quadrivalent” (a medication used to administer the influenza vaccine) was observed on the shelf inside of the refrigerator with 9 single dose, pre-filled syringes observed inside of the box. Observed on the box were storage guidelines from the manufacturer which indicated the medication should be stored between 36-46 degrees Fahrenheit. The medications were not observed to be stored per manufacturer’s guidelines. During an interview on 2/16/2022, at 1:44 PM, the alternate administrator indicated she was unsure when the vial of Tubersol was opened. The alternate administrator indicated she was unsure of the medication storage guidelines and indicated there were no refrigerator temperature logs. 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 of patient and personnel assignments. The findings include: Review of an agency job description on 2/15/2022, titled “Clinical Manager”, revised June 2018, stated, “… Responsibilities: … Makes staff and patient assignments ….” Review of an untitled agency document on 2/15/2022, which the alternate administrator identified as the staff’s schedule, indicated registered nurse (RN) D was scheduled to visit patient #9, start of care 2/17/2020, on 2/15/2022. During an interview on 2/15/2022, at 10:58 AM, the alternate administrator, who self-identified as the clinical manager, indicated the staff is assigned their visits each week and then pick the day and time the visit will be conducted. When queried what time RN D was visiting patient #9 on 2/15/2022, the alternate administrator indicated RN D was conducting the visit on 2/17/2022. When queried which patients RN D was visiting on 2/15/2022, the alternate administrator indicated she was not sure. 17-14-1(a)(1)(K)

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 contained clinical notes and a plan of care for 3 of 5 active clinical records reviewed. (#1 #4, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Timely Submission of Patient Documentation” revised February 2021, stated, “… Itineraries with all visit reports attached, must be submitted the next scheduled work day, not exceeding three (3) business days….” 2. Review of an agency policy obtained 2/21/2022, titled “Compliance with Laws and Regulations and Disclosure of Information” revised March 2018, stated, “… The Agency and its staff will furnish services in compliance with all applicable federal, state and local laws and regulations ….” 3. Clinical record review on 2/18/2022, for patient # 1, start of care 9/4/2020, evidenced an agency document titled, HHA [home health aide] Visit”, dated 2/14/2022, assigned to HHA C in the electronic health record. Review evidenced the visit note was blank. During an interview on 2/18/2022, at 11:47 AM, the alternate administrator indicated HHA C had conducted the HHA visit on 2/14/2022 but had not yet completed the visit note. 4. Clinical record review on 2/17/2022, for patient #4, start of care 2/2/2022, failed to evidence a plan of care. During an interview on 2/18/2022, at 3:40 PM, the alternate administrator indicated the plan of care was not developed yet and indicated maybe it would be completed by 2/21/2022. 5. Clinical record review on 2/17/2022, for patient #5, start of care 2/2/2022, failed to evidence a plan of care. During an interview on 2/18/2022, at 4:15 PM, the alternate administrator indicated the plan of care was not completed yet and indicated she would try to complete it over the weekend. 17-15-1(a)(1)-(7)

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 discharge summary was sent to the primary care physician in 1 of 2 active clinical records reviewed with a prior discharge from the agency (#5) and 2 of 2 closed clinical records reviewed. (#6, #7) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Discharge Summary” revised February 2021, stated, “… A Discharge Summary will be sent within 5 business days of patient discharge to the primary care practitioner ….” 2. Clinical record review on 2/17/2022, for patient #5, start of care 7/20/2020, evidenced an agency document titled “Physician Order”, electronically signed by the alternate administrator and dated 11/8/2021, which indicated the patient was discharged from the agency on per patient request. Review evidenced an agency document titled “Home Health Discharge Summary (Auto Generated), which was electronically signed by the alternate administrator and dated 11/23/2021. This document failed to evidence the document was completed within 5 business days of the patient’s discharge and failed to evidence the physician was sent the discharge summary. 3. Clinical record review on 2/14/2022, for patient #6, start of care 1/29/2021, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Discharge” electronically signed and dated by registered nurse (RN) D on 1/19/2022. This document indicated the patient was discharged from the agency on 1/19/2022. Review evidenced an agency document titled “Home Health Discharge Summary (Auto Generated)”, which was electronically signed by registered nurse D and dated 1/24/2022. This document failed to evidence the physician was sent the discharge summary. 4. Clinical record review on 2/15/2022, for patient #7, start of care 11/20/2021, evidenced an agency document titled “OASIS-D1 Discharge”, electronically signed by the alternate administrator and dated 1/13/2022. This document indicated the patient was discharged from the agency on 1/13/2022. Review of an agency document titled “Home Health Discharge Summary (Auto Generated)”, which was electronically signed by the alternate administrator and dated 1/23/2022, failed to evidence the document was completed within 5 business days of the patient’s discharge and failed to evidence the physician was sent the discharge summary. 5. During an interview on 2/18/2022, at 10:32 AM, the alternate administrator indicated the discharge summary is automatically generated by the electronic medical record. The alternate administrator indicated the clinical record did not indicate when the discharge summaries were sent to the physicians. At 4:14 PM, the alternate administrator indicated she did not know the discharge summary had to be sent to the physician within 5 business days. 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 observation, record review, and interview, the agency failed to ensure the entries in the clinical record were accurate, complete, signed and dated in 5 of 5 active clinical records reviewed. (#1, #2, #3, #4, #5) The findings include: 1. Review of an agency policy obtained 2/21/2022, titled “Medical Record Entries and Authentication” revised March 2018, stated, “… All entries in patient records will be legible, clear, complete and appropriately authenticated, dated and timed. All entries in the medical records will be authenticated by staff signature and title. By authenticating entries in the patient’s record, staff is validating the correctness of the information….” 2. During an observation of care at the home of patient #1, start of care 9/4/2020, on 2/16/2022, at 9:50 AM, home health aide (HHA) C was observed assisting the patient with a sponge bath while the patient sat on the toilet. The home health was not observed to have provided the patient with a shampoo, nail care and range of motion exercises. Clinical record review on 2/21/2022, evidenced an agency document titled “HHA Visit”, dated 2/16/2022 and electronically signed by HHA C. This document indicated the HHA provided a shower with chair, provided a shampoo, provided nail care, and provided range of motion. Review failed to evidence the clinical record was accurately completed to reflect the care provided. During an interview on 2/21/2022, at 1:08 PM, the alternate administrator indicated the HHA should document the care provided to the patient. 3. Clinical record review on 2/17/2022, for patient #2, start of care 7/16/2021, evidenced an agency document titled “SN [skilled nurse] Wound Care Visit”, with a date assigned on 2/9/2022, in the electronic health record which indicated skilled nursing services had been provided to the patient to include wound care. The electronic health record indicated the visit dated 2/9/2022 was assigned to registered nurse (RN) D. Review of the document in the electronic health record failed to evidence the signature and date by the clinician who completed the visit note. During an interview on 2/18/2022, at 12:29 PM, the alternate administrator indicated RN D might not have completed the visit note on 2/17/2022 to be able to sign the note. The alternate administrator indicated she would check the electronic health record to determine when RN D signed the note. No further information was provided. Review of an undated agency document titled “Patient Individualized Emergency Plan”, signed by RN D failed to evidence the RN dated the document. During an interview on 1/21/2022, at 1:14 PM, the alternate administrator indicated the RN should have dated the document. 4. Clinical record review on 2/21/2022, for patient #3, start of care 1/8/2022, evidenced an agency document titled “HHA Care Plan”, which was signed and dated by RN F on 1/8/2022. This document indicated the patient’s functional limitations included amputation. Review failed to evidence the patient had an amputation. During an interview on 2/21/2022, at 1:17 AM, the alternate administrator amputation had been checked by mistake. 5. Clinical record review on 2/17/2022, for patient #4, start of care 2/2/2022, evidenced an agency document titled “OASIS-D1 [Outcome and Assessment Information Set, a comprehensive assessment data collection tool] Start of Care”, which failed to evidence it was signed and dated by the clinician. This document indicated the patient was a male. Under a subtitle “Admission Summary”, this document indicated the patient was a female. This document indicated the skilled nurse was to provide services 1 time a week for 9 weeks starting the week of 11/29/2021. During an interview on 2/18/2022, at 3:41 PM, the alternate administrator indicated she performed the start of care assessment on 2/2/2022 and had not signed the document yet because the document was not finished. At 3:49 PM, the alternate administrator indicated the patient was a male and was documented incorrectly. The alternate administrator indicated the start date of the skilled nurse services was incorrect and indicated it must have been a carry over from the previous assessment from the patient’s prior admission with the agency. 6. Clinical record review on 2/17/2022, for patient #5, starts of care 7/20/2020 and 2/2/2022, evidenced an agency document titled “OASIS-D1 Start of Care”, with a visit date of 2/2/2022. This document failed to evidence it was signed and dated by the clinician. During an interview on 2/18/2022, at 4:02 PM, the alternate administrator indicated she completed the start of care comprehensive assessment and indicated she had not signed and dated the document yet because the document was not finished. Review of an agency document, titled “SN Teaching/Training Visit”, dated 11/3/2021, failed to evidence a signature and date by the clinician. During an interview on 2/21/2022, at 2:57 PM, the alternate administrator indicated the note should be signed and dated. The alternate administrator indicated the skilled nurse visit was completed on 11/3/2021 by licensed practical nurse (LPN) J. 17-15-1(a)(7)