Every finding on record at All 4 One Home Healthcare Services, Inc

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 a review of clinical records, it was determined the agency failed to ensure patients were informed about and consented to the frequency of proposed visits in advance of starting care for seven (7) of seven (7) patients in the survey sample (Clinical record #'s: 1-7). The findings: The informed consent signed at the time of admission and prior to services being provided for Patient #1, with a start of care date of 04/22/2022, failed to contain documentation of the frequency of Skilled Nursing services the patient would be receiving. The informed consent signed at the time of admission and prior to services being provided for Patient #2, with a start of care date of 09/27/2023, failed to contain documentation of the frequency of Skilled Nursing, Physical Therapy, and Occupational Therapy services the patient would be receiving. The informed consent signed at the time of admission and prior to services being provided for Patient #3, with a start of care date of 07/27/2023, failed to contain documentation of the frequency of Skilled Nursing, Physical Therapy, and Occupational Therapy services the patient would be receiving. The informed consent signed at the time of admission and prior to services being provided for Patient #4, with a start of care date of 01/16/2024, failed to contain documentation of the frequency of Skilled Nursing services the patient would be receiving. The informed consent signed at the time of admission and prior to services being provided for Patient #5, with a start of care date of 01/10/2024, failed to contain documentation of the frequency of Skilled Nursing services the patient would be receiving. The informed consent signed at the time of admission and prior to services being provided for Patient #6, with a start of care date of 08/15/2023, failed to contain documentation of the frequency of Skilled Nursing services the patient would be receiving. The informed consent signed at the time of admission and prior to services being provided for Patient #7, with a start of care date of 02/12/2024, failed to contain documentation of the frequency of Skilled Nursing and Home Health Aide services the patient would be receiving. The lack of documentation at the time of admission and prior to services being provided, regarding the frequency of services to be provided, was reviewed with and verified by the Clinical Manager prior to and during the exit conference on 02/28/2024.

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 a review of the agency's clinical records, a patient home visit and staff interviews, it was determined the agency staff failed to follow the individualized plans of care for skilled nursing, home health aide, and therapy visits at the ordered frequency for three (3) of seven (7) patients in the survey sample (Clinical records #: 2, 3 and 7). Findings: On 02/27/2024, the Office Manager (Staff Member #3) provided a policy titled "Patient Plan of Care". This policy read in part as follows: Care provided clients by all disciplines follows established plan of care. Order for therapy includes: a. The specific and mobilities to be used b. Comprehensiveness of services c. frequency of services d. duration of services. On 02/27/2024 the Quality Assurance Registered Nurse (Staff Member #9) stated, at this time period we had therapists out with illness and surgery and one of them quit. The clinical record of Patient #2 was reviewed for the period 01/25/2024 to 02/27/2024. According to patient's plan of care, the physician ordered physical therapy and occupational therapy to assess/evaluate and treat effective 01/26/2024. The clinical record failed to contain documentation of a physical therapy or occupational therapy visit. In addition, the clinical record failed to contain a physical therapy or occupational therapy care plan. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 2 pm. The clinical record of Patient #3 was reviewed for the period 01/23/2024 to 02/27/2024. According to patient's plan of care, the physician ordered physical therapy and occupational therapy to assess/evaluate and treat effective 01/22/2024. The clinical record failed to contain documentation of a physical therapy or occupational therapy visit. In addition, the clinical record failed to contain a physical therapy or occupational therapy care plan. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 11:05 am. The clinical record of Patient #7 was reviewed for the period 02/12/2024 to 02/27/2024. According to patient's plan of care, the physician ordered home health aide two (2) times a week for two (2) weeks and one (1) time a week for seven (7) weeks. The clinical record failed to contain documentation of a home health aide visit or care plan for a home health aide. In addition the the patient's plan of care contained orders for physical therapy and occupational therapy to assess/evaluate and treat effective 02/14/2024 with a frequency for both disciples of two (2) times a week for two (2) weeks then one (1) times a week for seven (7) weeks. The physical therapist documented a visit on 02/14/2024 with no other visits documented. The Medical Facilities Inspector conducted a home visit on 02/27/2024 and the patient stated, "The physical therapist didn't come back". The occupational therapist documented a visit on 02/21/2024 (9 days after the start of care). The clinical record failed to contain documentation of a home health aide visit. In addition, the clinical record failed to contain physical therapy or occupational therapy frequency visits as ordered on the plan of care. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 3 pm. The above noted findings were acknowledged by the Clinical Manager during the clinical record reviews and again during the exit conference conducted in the agency on 02/28/2024.

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 a review of clinical records, staff interviews, agency's wound care policy, and the agency's plan of care policy, the agency staff failed to document wound measurements/assessments and include a wound site on the plan of care. In addition, the care plans failed to have patient-specific/completed/realistic goals for seven (7) of seven (7) patients in the survey sample (Clinical Records for Patient’s # 1, 2, 3, 4, 5, 6, and 7). Findings: 1. The clinical record of Patient #1 was reviewed for the period 02/11/2024 to 02/27/2024. The plan of care contained 65 goals with the majority unrelated. The patient has a primary diagnosis of pressure ulcer of the sacral region and a secondary diagnosis of multiple sclerosis. The unrelated goals consisted of cardiac precautions, teaching, and medications. The patient is not on any cardiac medications. The goals also implemented instructions for the use of ear and ophthalmologic medications. The patient is not on any ear or ophthalmologic medications. The unrelated goals also included home health aide services. The patient does not have an order for home health aide services. The plan of care contained an incomplete goal that read as follows: Patient will be free of exacerbation from ______within 60 days". In addition, the plan of care contained an order for a pain parameter for pain levels > (more than) 10. Pain levels are scored from 0 to 10 with 10 being the worst pain ever felt. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 9:30 am. 2. The clinical record of Patient #2 was reviewed for the period 01/25/2024 to 02/27/2024. The plan of care contained four (4) incomplete goals that ended the sentence with the word "within" with no time-frame specifics. The plan of care contained an order for a pain parameter for pain levels > (more than) 10. Pain levels are scored from 0 to 10 with 10 being the worst pain ever felt. On 2/27/2024 the Clinical Manager stated, "I am working on taking the pain parameter of more than 10 off". The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 2 pm. 3. The clinical record of Patient #3 was reviewed for the period 01/23/2024 to 02/27/2024. The plan of care contained a unrelated goal of seizure precautions that consisted of seizure instructions and teaching. The patient is not on any seizure medications. The plan of care also contained eight (8) incomplete goals that ended the sentence with the word "within" with no time-frame specifics. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 11:05 am. 4. The clinical record of Patient #4 was reviewed for the period 01/16/2024 to 02/27/2024. The plan of care contained one (1) goal that was incomplete with no time-frame specifics. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 10:20 am. 5. The clinical record of Patient #5 was reviewed for the period 01/10/2024 to 02/27/2024. The patient has a primary diagnosis of sepsis, unspecified organism. The plan of care contained orders for skilled nursing to assess and evaluate wound care every Monday, Wednesday and Friday and to measure wound(s) weekly. The plan of care orders read as follows "Cleanse with wound cleanser, pat dry. Apply 1 inch iodoform packing, leaving small packing to easily remove". The plan of care failed to specify the site of the wound. The clinical record documented nine (9) skilled nursing visits with no documentation of wound measurements. On 02/27/2024 the Office Manager (Staff Member #3) provided a policy titled "Assessment of the Integumentary and Musculoskeletal System effective date May 9, 2008". This policy contained wound evaluation forms to describe the location, length, width, depth, drainage, color and odor of wound, however no rules or instructions on how this policy is followed. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 3:30 pm. 6. The clinical record of Patient #6 was reviewed for the period 02/15/2024 to 02/27/2024.The patient has a primary diagnosis of sepsis, unspecified organism. The plan of care contained orders for skilled nursing to cleanse the right foot with saline, pat dry apply betadine-soaked gauze, 4x4's secured with kerlix and light ace bandage. The clinical record documented four (4) skilled nursing visits with no wound assessments or wound measurements except for the start of care. During the clinical record review on 02/27/2024, the Clinical Manager stated, "There should be weekly measurements for all wounds". The plan of care also contained an incomplete goal that read as follows: Patient will be free of exacerbation from integumentary status ______within 60 days". In addition, the plan of care contained an order for a pain parameter for pain levels > 10. Pain levels are scored from 0 to 10 with 10 being the worst pain ever felt. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 1 pm. 7. The clinical record of Patient #7 was reviewed for the period 02/12/2024 to 02/27/2024. The patient has a primary diagnosis of hemiplegia and a secondary diagnosis of type 2 diabetes mellitus. The plan of care contained orders for "observation and assessment wound healing status, measure wound(s) weekly. Clean RLE (right lower extremity) wound with NS (normal saline) or DWC (dermal wound cleanser), pat dry and cover with dry dressing". The clinical record documented four (4) skilled nursing visits with no wound assessments or wound measurements except for the start of care with measurements of 6.5 cm x 1 cm x 0.02 cm. In fact, skilled nursing documented integumentary status as "normal" on 02/20/2024 and 02/22/2024. The plan of care also contained a incomplete order that read as follows: Observation and assessment nurse to report to MD if blood sugar > ___ or 10. Pain levels are scored from 0 to 10 with 10 being the worst pain ever felt. The Medical Facilities Inspector's findings were confirmed by the Clinical Manager during the clinical record review on 02/27/2024 at 3 pm. On 02/27/2024, the Office Manager (Staff Member #3) provided a policy titled "Patient Plan of Care". This policy read in part as follows: The sure [sic-To ensure] that the patient's Plan of Care consistently reflects the current problems, goals, and interventions relating to the services and care, which have been ordered. The above noted findings were acknowledged by the Clinical Manager during the clinical record reviews and again during the exit conference conducted in the agency on 02/28/2024.

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 staff interview and document review, it was determined the agency failed to ensure its performance improvement activities tracked adverse patient events, analyzed their causes, and implemented preventative actions. Findings: On 02/28/2024, the agency provided a document, Adverse Actions and stated it was the agency's policy for adverse events. The policy provided did not address adverse events; it referenced criminal background checks, the fair credit reporting act, and the equal employment opportunity commission. The Medical Facilities Inspectors advised Staff Member #4 that the policy provided was not related to adverse events. Staff Member #4 stated the agency had no further policy. The agency failed to provide any adverse event tracking for the last 12 months. On 02/28/2024, Staff Member #4 stated medication errors, incorrect wound care, and falls would be considered adverse events. Staff Member #4 stated that these events were incorporated into the agency's quality assessment performance improvement (QAPI) meetings each quarter. The Medical Facilities Inspectors requested documentation that adverse events were incorporated into the agency's QAPI program, but no evidence was presented to the Medical Facilities Inspectors prior to the end of the survey. Staff Member #4 presented the Medical Facilities Inspectors a form, Adverse Event Outcome Audit, and stated this form would be used to track adverse events. The form only contained information related to wound care and did not contain any field to track other types of adverse events. Staff Member #4 stated there was no such form to track medication errors medication errors and falls. Staff Member #4 stated that falls were likely not adequately being tracked because the electronic medical record does not prompt staff to ask patient about recent falls.

An unannounced Home Health Agency complaint investigation #61304 was conducted on December 27-29, 2021 at the above captioned agency by two (2) Medical Facilities Inspectors from The Office of Licensure and Certification, Virginia Department of Health. The agency reported an active census of 31. The following were completed/reviewed in conjunction with the survey: five (5) clinical records, the complaint log, admission packet, select policies, and interviews. The complaint was unsubstantiated with unrelated deficiencies cited. The agency was found to be out of compliance with 42 CFR 484, Conditions of Participation for Home Health Agencies (HHAs).

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on staff interview and review of clinical records it was determined the agency staff failed to follow physician’s orders for two (2) of five (5) clinical records in the survey samples (clinical record #2 and 5). The findings were: The electronic clinical records were reviewed both onsite and offsite in read only mode on December 27-28, 2021. The clinical record for patient #2 was reviewed for the certification period of 9/29/2021 through 11/27/2021. The plan of care/physician orders for skilled nursing were to visit two (2) times a week for four (4) weeks, one (1) time per week for five (5) weeks and two (2) as need. The skilled nurse failed to make a second visit the second week of care (10/03/2021). The nurse wrote a missed visit note on 10/09/2021 stating “nurse’s computer was (sic) did not detect scheduled appointment”. The clinical record for patient #5 was reviewed for the certification period of 10/26/2021 to 12/24/2021. The plan of care/physician orders for skilled nursing were to visit two (2) times a week for four (4) weeks, one (1) time per week for five (5) weeks and two (2) as needed. The skilled nurse missed the second visit the first week of care (10/26/2021). The skilled nurse wrote a missed visit note for 10/28/2021 stating “nurse not able to fulfill appointment”. An interview was conducted on 12/29/2021 at 9:40 AM with the Administrator and Chief Financial Officer. The Chief Financial Officer advised the nurses sometimes are unable to open the schedule on their phones to see who is on their schedule for the day as occurred for patient #2. The Administrator confirmed staffing is an issue and they do not have enough nurses to cover at times.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interviews and a review of clinical records, it was determined the agency failed to provide coordination of care for one (1) of five (5) clinical records reviewed in the survey sample (clinical record #2). Specifically, the clinical records indicate a delay and/or lack of communication between the nurse seeing the patient and the case manager as well as communication with the physician. The findings: The electronic clinical records were reviewed both onsite and offsite in read only mode on December 27-28, 2021. The clinical record for patient #2 was reviewed for the certification period of 9/29/2021 through 11/27/2021. The LPN (licensed practical nurse) attempted to make two visits to the patient on 12/05/2021 and 12/12/2021 after the patient had already been discharged from the agency on 11/27/2021. The nurse documented missed visit notes stating the patient did not open door/did not answer phone. The LPN was not aware the patient was no longer receiving services. The skilled nurse failed to notify the physician in a timely manner of missed visits. The nurse missed visits on 10/02/2021, 10/09/2021 and 10/18/2021 and the physician was not notified until 11/10/2021. The nurse missed a visit on 10/28/2021 and the physician was not notified until 12/03/2021. The case manager was not notified in a timely manner of missed visits by the LPN. Missed visit notes for 10/09/2021 and 10/18/2021 revealed the case manager was also not notified until 11/11/2021. In addition, the record revealed a recertification visit and discharge visit to include OASIS data were completed on patient #2 on the same date (11/27/2021). An interview with the administrator on 12/28/2021 at 8:55 AM revealed the nurse thought the visit on 11/27/2021 was a recertification visit and it was corrected to a discharge visit. An interview was conducted on 12/29/2021 at 9:40 AM with the Administrator. The Administrator confirmed staffing is an issue and “we (administrator and chief financial officer) are doing everything”.

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 staff interview and clinical record review it was determined the agency failed to send the patient's discharge summary to the primary care physician within 5 business days of discharge for one (1) of two (2) discharged patients in the survey sample (clinical record #2). The findings were: The electronic clinical records were reviewed both onsite and offsite in read only mode on December 27-28, 2021. The clinical record for patient #2 was reviewed for the certification period of 9/29/2021 through 11/27/2021. The patient was discharged from the agency on 11/27/2021. The discharge summary was not sent to the physician until 12/27/2021 as verified by the fax confirmation. An interview was conducted on 12/29/2021 at 9:40 AM with the Administrator and Chief Financial Officer. They acknowledged the finding and provided the copy of the fax confirmation.

Two (2) Medical Facilities Inspectors (MFI) from the Virginia Department of Health (VDH) Office of Licensure and Certification (OLC) conducted a Medicare Complaint Investigation, VA497690, at the above-noted agency from January 25 - 27, 2021 and February 1 - 3, 2021. In conjunction with the complaint investigation, the MFI reviewed the above-noted agency's Emergency Preparedness Plan (EPP). The agency was found not to be in compliance with 42 CFR 484.102, the Conditions of Participation, Emergency Preparedness for Home Health Agencies (Revised February 21, 2020), with standard-level deficiencies identified and cited in this report.

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 policy and procedure review, record review, and staff interview, it was determined the agency failed to include individual emergency preparedness plans (EPP) for each patient as part of their comprehensive assessment. Specifically, the agency failed to document individualized EPPs in the comprehensive assessments for eight (8) of eight (8) patients whose clinical records were reviewed as part of the survey sample. Findings: One (1) Medical Facility Inspector (MFI) reviewed the clinical records of eight (8) patients on January 25 - 26, 2021 and February 2 -3, 2021 with the assistance of the Quality Assurance Registered Nurse, Staff Member #1, on January 25 - 26, 2021 and the Authorization/Scheduling Coordinator, Staff Member #7, and a Physical Therapist, Staff Member #8, on February 2 -3, 2021. The MFI reviewed the agency's EPP on February 2-3, 2021. The MFI requested the agency's EPP on February 2, 2021 at approximately 3:00 PM. The agency provided the EPP to the MFI at approximately 3:30 PM. The EPP contained a document titled "Emergency Preparedness," Policy Number DC-001-A. The policy read in part as follows: "At a minimum, the policies and procedures must address the following: 1. The plans of the All-4-One patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment." The clinical records for eight (8) of eight (8) patients failed to contain evidence that an individualized EPP was developed or documented as part of the comprehensive assessment. This was confirmed during record review by the Quality Assurance Registered Nurse (QARN), Authorization/Scheduling Coordinator, and Physical Therapist. The MFI asked the Authorization/Scheduling Coordinator and Physical Therapist who was responsible for maintaining the agency's EPP on February 2, 2021 at approximately 5:00 PM. The Authorization/Scheduling Coordinator reported that the Director of Human Resources (DHR) was responsible for the agency's EPP. On February 3, 2021, the MFI interviewed the agency's DHR, Staff Member #3, regarding the agency's EPP. The MFI asked the DHR where the documentation of individualized EPP plans was maintained. The DHR reported that this information is provided to each patient as part of their admission packet paperwork and a copy should be located in each patient's clinical record. The MFI asked if the DHR could provide any additional evidence or documentation that individualized EPPs were developed and documented as part of the comprehensive assessments for the patients whose clinical records were reviewed as part of the survey sample. The DHR failed to supply any additional documentation or evidence prior to the exit conference on February 3, 2020 at approximately 5:30 PM. The above-noted deficiency was acknowledged during clinical record review on January 25-26, 2021 and February 2-3, 2021, during an interview with the DHR on February 3, 2021, and by the Clinical Supervisor, Staff Member #2, and Chief Financial Officer, Staff Member #6, during the exit conference on February 3, 2021.

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 document review, policy and procedure review, and staff interview, it was determined the agency failed to conduct adequate testing of its Emergency Preparedness Plan (EPP). Specifically, the agency failed to maintain documentation of either a full-scale exercise, additional exercise, or activation of the EPP for the year of 2019. Findings: One (1) Medical Facilities Inspector (MFI) reviewed the agency's EPP on February 2-3, 2021. The MFI requested the agency's EPP on February 2, 2021 at approximately 3:00 PM. The agency's EPP contained a document titled "Emergency Preparedness," Policy Number DC-001-A which contained the procedure for maintaining the agency's EPP testing requirements and required documentation in the following policy sections: "C. Participate in a full-scale exercise," "D. Conduct an additional exercise," and "E. Analyze the All-4-One Response." Section D of the policy read in part as follows: Analyze the All-4-One response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the All-4-One emergency plan as needed." Upon review, the MFI failed to find documentation or evidence of the testing of the EPP from 2019. The MFI asked the Authorization/Scheduling Coordinator, Staff Member #7, and Physical Therapist, Staff Member #8, who was responsible for maintaining the agency's EPP on February 2, 2021 at approximately 5:00 PM. The Authorization/Scheduling Coordinator reported that the Director of Human Resources (DHR) was responsible for the agency's EPP. On February 3, 2020 at approximately 9:00 AM, the MFI interviewed the agency's DHR, Staff Member #3, regarding the agency's EPP. The MFI asked the DHR if testing of the EPP occurred during the year of 2019. The DHR replied "In 2019, for new people, I just did a tabletop exercise. They take a test and they they receive a certificate. During orientation I will do a mock fire-drill." The MFI asked the DHR if the agency participated in either a full-scale community-based or facility-based exercise, completed a tabletop exercise, or if the EPP had been activated and its response analyzed during the year of 2019. The DHR stated "In 2019, I do not know if we did an exercise or not for the whole agency." The DHR stated "I cannot tell you if I have anything to show the plan was activated during 2019." No additional documentation or evidence was supplied to the MFI prior to the exit conference on February 3, 2021. The above-noted deficiency was acknowledged during an interview with the DHR on February 3, 2021, and again during the exit conference on February 3, 2021 at approximately 5:00 PM by the Alternate Administrator, Staff Member #2, and the Chief Financial Officer, Staff Member #6.

An unannounced Home Health Agency complaint investigation (#VA0050567) was conducted January 25, 2021 through January 27, 2021 by one MFI (Medical Facilities Inspector) and on February 2, 2021 through February 3, 2021 by two MFI's at the above captioned agency from The Office of Licensure and Certification, Virginia Department of Health. The agency reported 202 unduplicated admissions in the last twelve (12) months. The following were completed/reviewed in conjunction with the survey: three (3) home visits, eight (8) clinical records, nine (9) personnel files, review of selected policies and procedures, the complaint log, emergency preparedness plan, the employee handbook and admission packet review. Interviews were conducted with the Quality Assurance Registered Nurse (staff member #1), Alternate Administrator (staff member #2), Director of Human Resources (staff member #3), Chief Financial Officer (staff member #6), Scheduler (staff member #7) and Physical Therapist (staff member #8). The complaint was Substantiated with deficiencies cited. The agency was found to be out of compliance with 42 CFR 484, Conditions of Participation for Home Health Agencies (HHAs). Significant corrections are required due to substantial non-compliance with the following Conditions of Participation: 484.50 Patient rights 484.60 Care planning, coordination, quality of care 484.105 Organization and administration of services

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 a review of clinical records and staff interviews it was determined the agency failed to ensure the OASIS data accurately reflected the patient's status at the time of assessment for two (2) of two (2) patients in the survey sample who had a wound VAC dressing (clinical record #1 and #5). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021 and contained an OASIS (Outcome and Assessment information Set) Recertification assessment completed by the Alternate Administrator on 12/3/2020. The Recertification contained documentation of 4 pressure ulcers but no documentation of a wound VAC (vacuum assisted closure device used to drain wounds) dressing. During the clinical record review on 1/25/2021 it was documented in the patient's clinical record that he/she had a wound VAC dressing to the right ischium. Subsequent skilled nursing visits after 12/4/2020 contained documentation of a wound VAC to the right ischium on the following dates: 12/6/2020, 12/9/2020, 12/14/2020, and 12/16/2020. On 1/25/2021 at 3:00 PM this MFI (Medical Facilities Inspector) asked the Quality Assurance Registered Nurse (staff member #1) if this patient had a Wound VAC. Staff member #1 stated, yes and provided the MFI with a plan of care dated 6/5/2020 with a Wound VAC order. This plan of care was not the current plan of care. On 1/27/2021 at 10:30 AM this MFI asked staff member #1 why the wound VAC was not documented on the OASIS Recertification dated 12/3/2020; staff member #3 stated, the wound VAC was probably not attached at that time. Staff member #3 also stated, the wound VAC should have been documented in the integumentary comments of the current OASIS Recertification. 2. The clinical record for patient #5 was reviewed for the recertification period of 10/15/2020 to 12/13/2020. The plan of care contained physician orders for a wound VAC and read as follows: Wound VAC change to sacrum at 125 mmHg continuous suction Mon/Wed/Fri. The clinical record failed to contain skilled nursing documentation of the wound VAC for each visit. A "Clinical Summary" dated 10/23/2020 in the clinical record written by the Alternate Administrator (staff #2) read as follows: "Stage 3 pressure ulcer located in the sacrum with wound VAC set at 125 mmHg of continuous suction. Dressing change done every MWF (Monday, Wednesday and Friday)." The Recertification contained documentation of a stage 3 pressure ulcer but there was no documentation of a wound VAC (vacuum assisted closure device used to drain wounds) dressing. The recertification did not accurately reflect the patient's wound. The above noted inaccuracy in OASIS reporting was reviewed during the exit conference with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on staff interview, a review of clinical records, patient interview and review of the complaint log it was determined the agency failed to ensure property and person were treated with respect (see G428); failed to ensure patients would be free from neglect (see G430) failed to document that patients were allowed to participate in their care (see G434); failed to provide patients a written notice in advance of non-covered care (see G442); failed to assist the patient in a safe transfer or discharge when the patient required care that exceeded the agency's care capabilities (see 454); and failed to ensure that the resolutions to patient complaints were documented (see G484). The cumulative effect of these systemic problems resulted in the agency's inability to inform, promote, and protect the rights of their patients.

Property and person treated with respect CFR(s): 484.50(c)(1) Have his or her property and person treated with respect; This ELEMENT is not met as evidenced by: Based on a review of the complaint log, clinical records and patient interview, it was determined the agency failed to ensure that patients were treated with respect. Specifically, an agency staff member failed to be respectful of a patient in the patient's home for one (1) of eight (8) patients whose records were reviewed in the survey sample (Clinical record/Patient #3). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: The agency's complaint log contained a complaint dated 12/10/2020 from a staff member who documented that a visit was made to a patient's home and the patient reported an LPN (staff member #5) called and asked for money. The patient (patient #3) and the patient's family member also reported to the staff member that this LPN cooked, ate the patient's food, and flirted with members in the household. It was documented that on 12/10/2020 at 3:44 PM the agency's Director of Nursing (DON) called the patient's family member and documented that family member's account of the LPN (staff member #5). The LPN brought a child (to work), cooked food and ate it with the child. The LPN did not respect the patient's home, sat watching TV for 2-3 hours, did not check sore and never saw the LPN change the patient's bandage While the patient was in the hospital the LPN grabbed a plate of food (at the patient's home) then called the patient and said when out of the hospital that they were coming to pick up money. The DON reported this to the Administrator. The LPN (staff member #5) and the DON were not available for an interview since they are no longer employed by the agency. The above noted findings regarding the lack of respect for the patient was reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This ELEMENT is not met as evidenced by: Based on a review of clinical records, the complaint log, and interviews with staff, the patient and a physician's office employee it was determined the agency failed to ensure a patient was free from neglect by anyone furnishing services on behalf of the HHA (Home Health Agency). Specifically, agency staff neglected to notify a physician of changes in a wound's status for two (2) of eight (8) patients in the survey sample. Additionally, agency staff neglected to report to the physician multiple missed visits. (Clinical records #1 and #3) The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021. The patient's plan of care contained orders as follows: "Skilled nursing to assess and eval (evaluate) pressure sores, wound care, paraplegia, colostomy, care of Foley cath." No specific wound care orders were on the plan of care. A previous plan of care dated 6/5/2020 did contain orders for a Wound VAC (vacuum assisted closure device to pull drainage away from wound) The clinical record contained visits with inconsistent wound care documentation and multiple missed visits as follows below: 12/6/2020 - LPN (staff member #4) visit note revealed wound vac at 125 mmHG (recertification order is 150 mmHG). There was no current order for a Wound VAC dressing. 12/7 to 12/13/2020 - 2 Skilled nursing visits were provided for the week however 3 visits per week were ordered. 12/9/2020 - LPN (staff member #4) visit note revealed wound VAC at 125 mmHG. 12/11/2020 - LPN (staff member #4) missed visit due to the patient refused. 12/14/2020 - LPN (staff member #4) visit note revealed a wound VAC at 125 mmHG dressing. 12/16/2020 - LPN (staff member #4) visit note a revealed wound VAC at 125 mmHG dressing. 12/18/2020 - LPN (staff member #4) missed visit due to the LPN not feeling well. 12/21/2020 to 12/27/2020 - No skilled nursing visits this week. 12/28/2020 to 1/3/2021 - 2 Skilled nursing visits for this week when 3 were ordered. 12/29/2020 - LPN (staff member #5) visit note revealed wounds were cleansed with Normal Saline. 12/30/2020 - LPN (staff member #5) visit note revealed wounds of the right buttocks and mid back were changed with no mention of what was used. (recertification order documented 4 different wound sites). 1/4/2021 to 1/10/2021- No skilled nursing visits this week. 1/11/2021 to 1/17/2021 - 1 Skilled nursing visit for the week when 3 were ordered. 1/14/2021-Registered Nurse visit note revealed no documentation of a wound VAC. 1/18 to 1/24/2021- 1 Skilled nursing visit for this week when 3 visits were ordered. 1/18/2021 - Registered Nurse visit note revealed no documentation of a wound VAC. A telephone call was placed to the patent's physician. A return call was received on 1/28/2021 at 10:00 AM from the physician's medical assistant. The MFI asked if the physician was aware of the multiple missed visits from the agency. The physician's medical assistant stated, we just received a missed visit for 12/18/2020 on 1/25/2021 (38 days) later. In addition, the patient's physician's assistant explained that when the patient called the office to notify the physician that the nurse did not make a visit. I (medical assistant) told the agency this was neglect and they would say we don't have staff but we are looking. On 2/2/2021 at 2:50 PM the MFI (Medical Facilities Inspector) conducted interviews with the Chief Financial Officer, Alternate Administrator and Scheduler and asked how the agency handled missed visits. The scheduler explained when there is a missed visit, a reason is chosen and then given to the agency's record keeper/supply handler to physically fax to the physician. The MFI provided the above agency staff members with numerous missed visits that appeared to have not been faxed to the patient's physician as evidenced by no transmittal date or time on the documents. The above noted staff members acknowledged the missed visits were not faxed to the physician and that inconsistent wound care was provided with no specific orders 2. The clinical record for patient #3 was reviewed for the recertification period of 11/11/2020 to 1/9/2021. The patient's plan of care contained orders as follows: "Wound Care Procedure: cleanse with DWC (dermal wound cleanser) pat dry then apply allevyn dressing; Instructions/teaching signs and symptoms of wound infection and appropriate actions to take." The plan of care did not describe specific areas of the body for wound care to be performed. The clinical record failed to contain documentation of the physician being notified of changes in the wound status and missed visits as follows: 11/23/2020 - LPN (staff member #5) visit note documented "wound bed has drainage foul odor." 11/26/2020 - LPN (staff member #5) visit note documented "patient wound is draining green, odor noted." 11/29/2020 to 12/5/2021 - No Skilled nursing visits for the week (plan of care had ordered 2 skilled nursing visits weekly). 12/11/2020-A ROC (resumption of care) was documented and skilled nursing frequency changed to 3 visits weekly). 12/12/2020 to 12/19/2020 - No Skilled nursing visits for the week (plan of care had ordered 3 skilled nursing visits weekly). No skilled nursing visits were made until 10 days after the ROC of 12/11/2020. 12/27/2020 to 1/2/2021 - 2 Skilled nursing visits for the week (plan of care had ordered 3 skilled nursing visits weekly). 1/3/2021 to 1/9/2021 - 1 Skilled nursing visit for the week was documented when 3 visits were ordered The agency's complaint log was reviewed on 1/25/2021 and revealed a staff member issue (LPN-staff member #5) for patient #3 and a wound care issue. A complaint was documented 12/10/2020 by a staff member who made a skilled nursing visit to the patient's home. The patient's family member complained of about an LPN (staff member #5). Documentation revealed that on 12/10/2020 at 3:44 PM the agency's Director of Nursing (DON) called the patient's family member and documented that family member's account of LPN (staff member #5). The LPN did not check sore and never saw the LPN change the patient's bandage. The complaint log also contained documentation regarding the LPN (staff member #5) calling the DON to report the patient's (#3) wound as green with no odor or fever however, the notes for 11/23/2020 and 11/26/2020 documented the wound had green drainage and a foul odor. This was inconsistent with the complaint log notes. On 12/4/2020 the DON called the patient's physician at 8:30 AM (4 days later) with the LPN's findings. On 2/2/2021 the scheduler (staff member #7) provided the MFI with a report from the hospital that documented the patient's admission date as 12/5/2020 and a discharge date of 12/8/2020. The hospital documented a superinfection of chronic stage IV ischial wound. The agency's staff member neglected to promptly alert the physician of a deteriorating wound in a timely manner. On 2/2/2021 at 4:15 PM the MFI interviewed scheduler (staff member #7) regarding the patient having numerous missed visits that appeared not to have been faxed to the patient's physician as evidenced by no transmittal date or time on the documents. The staff members acknowledged the failed missed visit documentation to the physician and failure to promptly alert the physician of a deteriorating wound. The above noted findings regarding negligent care were reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 review of clinical records, patient interview, observations made during a home visit and staff interview it was determined the agency failed to document informing patients verbally and in writing regarding the disciplines to furnish care and or the frequency of those proposed visits for eight (8) of eight (8) clinical records reviewed in the survey sample (Clinical records #'s 1-8). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: The clinical records #s 1-8 were reviewed for consents. The MFI (Medical Facilities Inspector) noted there was no documentation in the records regarding the disciplines to furnish care or the frequency of those visits on the agency consent form. On 1/26/2021 at 9:05 AM the MFI called patient #1 via telephone and asked if their plan of care was hand delivered to them or mailed to their residence. Patient #1 stated, no and explained that the nurses from the agency never had a set schedule. On 2/2/2021 at 2:45 the MFI interviewed the Alternate Administrator and asked how do patients know which disciplines would be visiting and the frequency of those visits. The Alternate Administrator stated, I let them see their plan of care on recertification so I can go over their medications and I will tell them orally. On 2/3/2021 at 3:30 PM the MFI visited patient #8 as a home visit. During the home visit, the MFI reviewed the patient's admission packet from the agency. There was no documented evidence of the disciplines to furnish care or the frequency of those visits in the admission packet. The MFI asked patient #8 if he/she knew when the agency nurse was coming and Patient #8 stated, no. The above noted findings regarding the lack of providing patients with a written notice in advance of the disciplines furnishing care and the proposed frequency was acknowledged by the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on review of clinical records and staff interviews, it was determined the agency failed to provide a Notice of Medicare Non-Coverage (NOMNC) to Medicare patients in advance of terminating care for two (2) of three (3) closed/discharged patients whose records were reviewed in the survey sample, for which a NOMNC was applicable. (Clinical records #1 and #4). The findings: Six (6) discharged/closed clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1, a Medicare beneficiary, was discharged from the agency on 1/25/2021. During the clinical record review on 1/26/2021 at 10:30 AM the MFI (Medical Facilities Inspector) asked Quality Assurance Registered Nurse (staff member#1) if the patient was discharged. Staff member #1 stated, yesterday, the family doctor or nurse practitioner called me and told me to discharge the patient. The MFI requested to see evidence of the discharge. Staff member #1 did not provide evidence of a discharge and/or a referral for the patient. The MFI then asked if the patient knew of the discharge and staff member #1 stated, no we have not told (patient #1) yet. The patient record failed to contain evidence the agency provided the patient an advanced, written notice of discharge/Medicare Notice of Non-Coverage (NOMNC) prior to discharge from the agency. 2. The clinical record for patient #4, a Medicare beneficiary, was discharged from the agency on 1/13/2021. During the clinical record review on 1/26/2021 at 5:00 PM the MFI requested for staff member #1 to provide evidence of discharge. Staff member #1 did not provide evidence of discharge but provided a fax transmittal cover sheet dated 1/21/2021 of the patient's clinical record (89 pages) to another home health care agency. Staff member #2 stated, the patient was discharged due to staffing issues and referred to another agency. The patient record failed to contain evidence the agency provided the patient an advanced, written notice of discharge/Medicare Notice of Non-Coverage (NOMNC) prior to discharge from the agency. The above noted findings regarding the lack of providing patient a written notice in advance of terminating on-going care was acknowledged by the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on review of clinical records, patient and staff interviews it was determined the agency failed to provide the necessary services required to meet the needs of a patient for one (1) of six (6) patients in the survey sample (Clinical record #1). The findings were: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021. The record contained multiple missed visits for this recertification period. On 2/2/2021 at 2:50 PM the MFI conducted interviews with the Chief Financial Officer, Alternate Administrator and Scheduler and asked how the agency handled missed visits. The scheduler explained when there is a missed visit, a reason is chosen and then given to the agency's record keeper/supply handler to physically fax to the physician. The MFI provided the above agency staff members with numerous missed visits that appeared not to have been faxed to the patient's physician as evidenced by no transmittal date or time on the documents. The above noted staff members acknowledged the failed missed visit documentation to the physician and stated during the interview that the agency did not have a nurse who could assist with a wound VAC dressing for 32 days (December 25, 2020 to January 26, 2021). On 1/26/2021 at 10:30 AM it was revealed during an interview with staff member #1 that the patient was discharged on 1/25/2021. The agency failed to discharge or transfer the patient within an appropriate time period when the agency was unable to provide skilled services. The above noted findings regarding the failure to discharge or transfer the patient when the agency could no longer meet the patient's needs was acknowledged by the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on review of the agency's complaint log, select document review, patient and staff interviews it was determined the agency failed to document each complaint with a documented investigation and/or resolution of the complaint for 12 of 26 complaints reviewed from 6/18/2020 to 12/18/2020. The findings: Twenty six complaints were reviewed in the agency on 1/25/2021. The complaint log revealed an incomplete process for follow up/resolution of the complaint and a pattern of scheduling and wound care issues. On 1/25/2021 at 1:30 PM, the Quality Assurance Registered Nurse (staff member #1) provided the complaint log to this MFI (Medical Facilities Inspector). 7/23/2020 a complaint from a patient' family member was documented regarding an aide to not visit anymore. No investigation or a follow up/resolution was documented of this complaint. (No date) a complaint from a patient was documented regarding a missed LPN (Licensed Practical Nurse-staff member #4) visit with no notification. A follow up/resolution was not documented as to whether this LPN ever made a home visit. 10/21/2020 a complaint from the agency's LPN (staff member #4) documented that a patient's family member was upset that the agency did not order a specific DME (durable medical equipment) for the patient. The agency's LPN explained to the patient's family member that a physical therapy evaluation would be needed to assess the patient to ensure he received the DME that would benefit the most. The patient's family member refused the physical therapy evaluation. The agency failed to document the patient's specific DME requested or why the patient's family member refused a physical therapy evaluation as reported by this LPN. 10/30/2020 a complaint from a patient was documented regarding an LPN (staff member #4) not to come to the home anymore. The agency failed to document the resolution to remove this LPN from the patient's care as requested by the patient. 11/23/2020 at 12:42 PM a complaint from a patient was documented regarding a LPN (staff member #4) who requested the patient to text regarding visit times but the LPN did not respond to the patient's phone and texts. A resolution with no date was documented for the patient to call the office after hours and the on call person will be able to reach the clinician, however there is no follow up/resolution if the LPN made a visit. On 11/27/2020 a complaint from the same patient (for the 11/23/2020 complaint) was documented regarding missed LPN (staff member #4) visit. A follow up/resolution was not documented as to who would provide visits to the patient or an investigation of why the nurse did not attempt to visit the patient. 12/10/2020 a complaint from a staff member documented that a visit was made at a patient's house who reported an LPN (staff member #5) called and asked for money. The agency failed to document a follow up/resolution as to whether this LPN will make future visits to this patient. 12/14/2020 a complaint from a patient (patient #1) was documented regarding missed LPN (staff member #4 and #5) visits on 4-5 consecutive Fridays and that the LPN was unable to change wound dressings. An investigation was not documented regarding the patient's wound status. The agency also failed to document if the physician was notified that wound care had not been performed and when the patient received care. 12/17/2020 a complaint from a patient was documented regarding a missed LPN (staff member #4) visit for the day before and this day. No investigation was documented of why the nurse did not attempt to visit the patient for two days. 12/17/2020 a complaint from a doctor's office and two from an infusion provider and home care management solutions were documented regarding a patient's lab work. The agency failed to document an investigation. 12/17/2020 a complaint from a patient who called four times was documented regarding a missed LPN (staff member #4) visit or communication for the day. No investigation was documented. 12/18/2020 a complaint from a patient was documented regarding missed LPN (staff member #4) visits. No investigation was documented. Select Agency Policy Review: A copy of the agency's complaint policy was provided on 1/29/2021 at 2:58 PM to the MFI (Medical Facilities Inspector) via email by the Director of Human Resources. The policy was titled, Patient Complaints and Grievance a select portion read as follows: "shall regard all patients complaints as a serious issue and will have an effective procedure in place that will be utilized to investigate patient complaints and provide a systemic means of monitoring and resolving complaints"; "Interventions for serious patients issue involving care delivery may result in disciplinary action, notification or regulatory boards and/or initiation of the peer review process." The above noted findings regarding the incomplete process for the handling of complaints and their resolution for patients was reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 staff interviews and clinical record review it was determined the agency failed to provide safe care as ordered by a physician. Specifically the agency failed provide care to patients according to their plans of care (see G572); the agency failed to ensure that all plans of care were complete and accurate (see G574); The agency failed to ensure conformance with physician orders (see G578); The agency failed to administer treatments only as ordered by the patient's physician (see G580); The agency failed to revise the plans of care and progress toward outcomes (see G592). The cumulative effect of this problem resulted in the agency's inability to provide safe and appropriate care to all patients.

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 a review of clinical records and interviews it was determined the agency staff failed to follow the individualized plans of care for eight (8) of eight (8) patients in the survey sample (Clinical records #1, #2, #3, #4, #5, #6, #7 and #8). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021. Skilled nursing was ordered for three (3) times per week for nine (9) weeks. The clinical record contained documentation of less than 3 visits per week as noted below; - one (1) SN visit was documented for the week of 12/4/2020 through 12/6/2020 (week 1 for SN), - one (1) SN visit was documented for the week of 12/7/2020 through 12/13/2020 (week 2 for SN) with a note in the clinical record for 12/11/2020 that stated, patient refused visit and no documentation was provided to indicate the agency staff attempted to visit the patient again that week, - two (2) SN visits were documented for the week of 12/14/2020 through 12/20/2020 (week 3 for SN) with a note in the clinical record for 12/18/2020 that stated, LPN not feeling well and no further attempts were documented to show the nurse attempted to visit the patient again that week, - zero (0) SN visits were documented the week of 12/21/2020 through 12/27/2020 (week 4 for SN), - two (2) SN visits were documented for the week of 12/28/2020 through 1/3/2021 (week 5 for SN), - zero (0) SN visits were documented for the week of 1/4/2021 through 1/10/2021 (week 6 for SN), - one (1) SN visit was documented for the week of 1/11/2021 through 1/17/2021 (week 7 for SN) and - one (1) SN visit was documented for the week of 1/18/2021 through 1/24/2021 (week 8 for SN). On 2/2/2021 at 2:50 PM the MFI conducted interviews with the Chief Financial Officer, Alternate Administrator and Scheduler and asked how the agency handled missed visits. The scheduler explained when there is a missed visit, a reason is chosen and then given to the agency's record keeper/supply handler to physically fax to the physician. The MFI provided the above agency staff members with numerous missed visits that appeared not to have been faxed to the patient's physician as evidenced by no transmittal date or time on the documents. The above noted staff members acknowledged the failed missed visit documentation to the physician. In addition, the plan of care did not contain orders for a wound VAC (vacuum assisted closure) that was documented on four (4) out of nine (9) SN visits. On 1/25/2021 at 3:00 PM the MFI (Medical Facilities Inspector) interviewed Quality Assurance Registered Nurse (staff member #1) regarding why the wound VAC orders were not on the patient's plan of care. Staff member #1 provided the MFI with a wound VAC order from the recertification dated 6/5/2020 and verified this is what was used as orders for the plan of care. The clinical record failed to contain documentation that the patient's physician was notified of the wound care services not being provided in accordance with the patient's plan of care. 2. The clinical record for patient #2 was reviewed for the recertification period of 11/11/2020 to 1/9/2021. Skilled nursing was ordered two (2) times per week for nine (9) weeks. The clinical record contained documentation of zero (0) SN visit the week of 11/11/2020 through 11/14/2020 (week 1 for SN) when 2 nursing visits were ordered, A Resumption of Care (ROC) dated 11/25/2020 ordered SN two (2) times per week for nine (9) weeks. The clinical record contained zero (0) SN visits the week of 11/11/2020 through 1/14/2020 (ROC week 1 for SN) when 2 nursing visits were ordered, Another ROC dated 12/17/2020 ordered SN visits two (2) times per week for nine (9) weeks. The clinical record contained zero (0) SN visits the week of 12/18/2020 through 12/19/2020 (second-ROC week 1 for SN) when 2 nursing visits were ordered, zero (0) SN visit the week of 12/20/2020 through 12/25/2020 (second-ROC week 2 for SN) when 2 nursing visits were ordered. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 3. The clinical record for patient #3 was reviewed for the recertification period of 11/11/2020 to 1/9/2021. Skilled nursing was ordered two (2) times per week for nine (9) weeks. The clinical record contained documentation of only one (1) SN visit the week of 11/11/2020 through 11/14/2020 (week 1 for SN), A ROC dated 12/11/2020 ordered SN visits three (3) times per week for nine (9) weeks. The clinical record contained zero (0) SN visits the week of 12/13/2020 through 12/19/2020 (ROC week 1 for SN) when 3 nursing visits were ordered, two (2) SN visits the week of 12/27/2020 through 1/2/2021 (ROC week 3 for SN) and one (1) SN visit the week of 1/3/2021 through 1/9/2021 (ROC week 4 for SN) when 3 nursing visits were ordered. On 2/2/2021 at 4:15 PM the MFI asked the scheduler (staff member #7) why the patient was not seen after the ROC on 12/11/2020 for 10 days (until 12/22/2020). Staff member #7 stated, that's the week the LPN (staff member #4) resigned and we missed all these visits. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 4. The clinical record for patient #4 was reviewed for the recertification period of 11/17/2020 to 1/25/2021. Skilled nursing visits were ordered three (3) times per week for one (1) week and then two (2) times per week for eight (8) weeks. The clinical record contained documentation of zero (0) SN visits the week of 11/27/2020 through 11/29/2020 (week 2 for SN), one (1) SN visit the week of 11/30/2020 through 12/6/2020 (week 3 for SN), one (1) SN visit the week of 12/7/2020 through 12/13/2020 (week 4 for SN) with a note in the clinical record for 12/11/2020 that stated, LPN not feeling well, one (1) SN visit the week of 12/14/2020 through 12/20/2020 (week 5 for SN), one (1) SN visit the week of 12/21/2020 through 12/27/2020 (week 6 for SN), zero (0) SN visits the week of 12/28/2020 through 1/3/2021 (week 7 for SN) with a note in the clinical record for 12/30/2020 that stated, patient refused wound treatment, and zero (0) SN visits the week of 1/4/2021 through 1/10/2021 (week 8 for SN) with a note in the clinical record for 1/5/2021 that stated, LPN not feeling well and no further communication was documented to show the nurse attempted to visit the patient again. The clinical record also failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 5. The clinical record for patient #5 was reviewed for the recertification period of 10/15/2020 to 12/13/2020. Skilled nursing visits were ordered three (3) times per week for nine (9) weeks. The clinical record contained documentation of only one (1) SN visit the week of 10/15/2020 through 11/18/2020 (week 1 for SN). In addition, the plan of care contained orders for a wound VAC and read as follows: Wound VAC change to sacrum at 125 mmHg continuous suction Mon/Wed/Fri. The clinical record failed to contain skilled nursing care documentation for the wound VAC on each visit. A Clinical Summary note dated 10/23/2020 was documented in the clinical record by the Alternate Administrator (staff #2) and read in part as follows: "Stage 3 pressure ulcer located in the sacrum with wound vac set at 125 mmHg of continuous suction. dressing change done every MWF (Monday, Wednesday and Friday)." On 1/25/2021 at 4:30 PM the MFI asked staff member #1 if the patient had a wound VAC. Staff member #1 stated, I don't know. The clinical record failed to contain documentation that the patient's physician was notified that wound care was not being provided in accordance with the patient's plan of care. 6. The clinical record for patient #6 was reviewed for the certification period of 10/28/2020 to 12/26/2020. Skilled nursing visits were ordered two (2) times per week for one (1) week, then three (3) times per week for eight (8) weeks. The clinical record contained documentation of less than 3 visits per week for the following weeks; - two (2) SN visits the week of 11/1/2020 through 11/7/2020 (week 2 for SN), - two (2) SN visits the week of 11/8/2020 through 11/14/2020 (week 3 for SN), - two (2) SN visits the week of 11/15/2020 through 11/21/2020 (week 4 for SN), - two (2) SN visits the week of 11/22/2020 through 11/28/2020 (week 5 for SN), - two (2) SN visits the week of 11/29/2020 through 12/5/2020 (week 6 for SN), and - two (2) SN visits the week of 12/13/2020 through 12/19/2020 (week 8 for SN). In addition, the plan of care contained orders for wound care and read as follows: Cleanse sacral wound with DWC (dermal wound cleanser) then dampened gauze with 0.125% Dakins apply to wound bed cover with DSD (dry sterile dressing). The clinical record contained documentation of a wound VAC applied on 11/6/2020 by LPN (staff member #5) an incorrect wound care. The clinical note from staff member #5 documented under the title "Skilled Intervention" and read as follows: Wound cleansed with N/S (normal saline) with 4x4 gauze, wound VAC applied." On 1/26/2021 at 2:30 PM the MFI asked staff member #1 where is the wound VAC order for 11/6/2020 and staff member #1 stated, I don't know". Staff member #1 did not provide the MFI with an order for a wound VAC. No other clinical notes documented a wound VAC during this certification period. The clinical record failed to contain documentation that the patient's physician was notified that wound care was not being provided in accordance with the patient's plan of care 7. The clinical record for patient #7 was reviewed for the certification period of 12/21/2020 to 2/8/2021. Skilled nursing services were ordered three (3) times per week for nine (9) weeks. The clinical record contained documentation of less than 3 nursing visits per week for the following weeks: - zero (0) SN visits the week of 1/3/2021 through 1/9/2021 (week 3 for SN), - zero (0) SN visits the week of 1/10/2021 through 1/6/2021 (week 4 for SN), - two (2) SN visits the week of 1/17/2021 through 1/23/2021 (week 5 for SN), - two (2) SN visits the week of 11/15/2020 through 11/21/2020 (week 4 for SN), - two (2) SN visits the week of 11/22/2020 through 11/28/2020 (week 5 for SN), - two (2) SN visits the week of 11/29/2020 through 12/5/2020 (week 6 for SN), - two (2) SN visits the week of 12/13/2020 through 12/19/2020 (week 8 for SN). On 1/27/2021 at 1:00 PM the MFI asked staff member #1 why the patient did not have SN visits for 2 weeks from 1/3/2021 to 1/16/2021 and staff member #1 stated, LPN (staff member #5) was terminated and has not given these notes to us. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 8. The clinical record for patient #8 was reviewed for the certification period of 1/5/2021 to 3/5/2021. Skilled nursing services were ordered two (2) times per week for one (1) week, then three (3) times per week for eight (8) weeks. The clinical record contained documentation of one (1) SN visit the week of 1/5/2021 through 1/9/2021 (week 1 for SN) when 2 nursing visits were ordered, - zero (0) SN visits the week of 1/10/2021 through 1/6/2021 (week 2 for SN) when 3 nursing visits were ordered, - - two (2) SN visits the week of 1/17/2021 through 1/23/2021 (week 3 for SN) when 3 nursing visits were ordered and - zero (0) SN visits the week of 1/24/2021 through 1/30/2021 (week 4 for SN) when 3 nursing visits were ordered. The clinical record failed to contain documentation that the physician was notified of the visits not being provided in accordance with the patient's plan of care. The lack of documentation regarding services being provided according to the above noted plans of care and physician orders was reviewed and acknowledged by the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 a review of clinical records and staff interview, it was determined the agency's staff failed to ensure plans of care contained all wound locations and wound care treatments as ordered by the physician for five (5) of eight (8) patients in the survey sample (Clinical records #1, #3, #4, #5 and #7). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021. The plan of care contained a diagnosis of pressure ulcer of right buttock, stage 4; pressure ulcer of other site, stage 3; pressure ulcer of other site, stage 2. The plan of care contained orders for a Skilled Nurse (SN) to assess and evaluate pressure sores, wound care, paraplegia, colostomy, and care of foley catheter. The clinical record did contain wound care documentation for a Wound VAC (dressing which is a vacuum assisted closure device to pull drainage away from wound) by the skilled nurses. On 1/25/2021 at 3:00 PM the MFI asked the Quality Assurance Registered Nurse (staff member #1) where were the wound care orders? Staff member #1 provided the MFI with a prior plan of care dated 6/5/2020 that contained orders as follows: Wound VAC on ischium, white foam on undermining site at 150 HHmg [sic]. Back side apply Santyl (enzyme used to removed dead tissue) with Dakins (antiseptic) wet to dry and ABD (bulky gauze) pads. Small back site-betadine (antiseptic) cleanse with ABD. Leg site dressing with xeroform (petrolatum gauze). Foot; hydrofera blue dressing (antimicrobial foam dressing) change with 4x4 all care to be done 3 times weekly. The current and active plan of care failed to contain wound care orders. 2. The clinical record for patient #3 was reviewed for the certification period of 11/11/2020 to 1/9/2021. The plan of care contained orders for a SN to cleanse with DWC (dermal wound cleanser) pat dry then apply Allevyn (hydrocellular foam pad) dressing. The plan of care failed to contain the specific location for wound care. 3. The clinical record for patient #4 was reviewed for the recertification period of 11/27/2020 to 1/25/2021. The plan of care contained orders for a SN to provide wound care, dressing change for patient as per MD (Medical Doctor) order. On 1/25/2021 at 4:00 PM the MFI asked staff member #1 where are the specific wound care orders? Staff member #1 provided the MFI with a recertification dated 11/23/2020 that contained orders as follows: Cleanse both lower leg wounds with DWC apply Alginate (absorbent dressing that protects the are from bacteria), ABD pads, 4x4's gauze secured with kerlix and tape change twice a week and prn (as needed). The current and active plan of care failed to contain the specific location and treatment for the wound care. 4. The clinical record for patient #5 was reviewed for the recertification period of 10/15/2020 to 12/13/2020. The plan of care contained orders for a SN to provide wound VAC care to sacrum at 125 mmHg continuous suction Mon/Wed/Fri. On 1/25/2021 at 4:30 PM the MFI asked staff member #1 where are the specific wound dressing orders? Staff member #1 provided the MFI with a verbal order dated 10/13/2020 that contained orders as follows: 10/15/20-12/13/20 for continued wound care 3x/week for 9 weeks as ordered by physician. The plan of care failed to contain specific treatment/dressing orders for the wound VAC dressing. 5. The clinical record for patient #7 was reviewed for the recertification period of 12/21/2020 to 2/18/2021. The plan of care did not contain wound care orders however, the DME (Durable Medical Equipment) listed wound care supplies as follows: 4x4's, wound cleanser, kerlix, Aquacel AG, border gauze 6x6. In addition, the clinical record contained wound care documentation by the skilled nurses. On 1/27/2021 at 1:00 PM the MFI asked staff member #1 where was the wound care order? Staff member #1 provided the MFI with a prior plan of care dated 10/22/2020 that contained orders as follows: SN to cleanse right anterior thigh with DWC, pat dry, apply Aquacel AG then border dressing. The current plan of care failed to contain wound care orders. The above noted findings regarding the lack of the required content of the plan of care was reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This STANDARD is not met as evidenced by: Based on review of clinical records and staff interview it was determined the agency staff failed to follow physicians orders in a timely manner and failed to notify the physician of the delay in providing care. Specifically, the skilled nurse (SN) failed to resume care after hospitalization when resumption orders were written for two (2) of two (2) patients in the survey sample with resumption of care orders (Clinical records #2 and #3). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #2 was reviewed for the recertification period of 11/11/2020 through 1/9/2021. The clinical record contained resumption of care orders (ROC) dated 11/25/2020 for the skilled nurse (SN) to visit two (2) times per week for nine (9) weeks. The SN failed to make a visit to the patient to reassess after the resumption of care visit until 12/1/2020 (week 2). The clinical record contained another ROC dated 12/17/2020 for the SN to visit two (2) times per week for nine (9) weeks. After the ROC, the SN failed to make a visit to reassess the patient and the patient was discharged from the agency on 12/25/2020 (8 days later). On 2/2/2021 at 5:00 PM the MFI (Medical Facilities Inspector) asked the Scheduler (staff member #7) why there were no SN visits after the two ROCs? Staff member #7 stated, there again this patient was supposed to be seen by the LPN (staff member #4) and didn't. The clinical record failed to contain evidence the SN/agency contacted the physician related to the missed visits. 2. The clinical record for patient #3 was reviewed for the certification period of 11/11/2020 through 1/9/2021. The clinical record contained resumption of care orders (ROC) dated 12/11/2020 for the skilled nurse (SN) to visit three (3) times per week until the end of the certification period. The SN failed to make a visit to reassess the patient until 12/22/2020 (10 days later). On 2/2/2021 at 4:15 PM the MFI asked the Scheduler (staff member #7) why were there missed visits. Staff member #7 stated, that's the week the LPN (staff member #4) resigned and missed all these visits. The clinical record failed to contain evidence the SN/agency contacted the physician related to the delay in nursing visits. The failure to notify the physician of missed visits was reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 a review of clinical records, staff interview and complaint log review it was determined the agency failed to ensure services and treatments were administered only as ordered by a physician for two (2) of eight (8) patients whose clinical records were reviewed in the survey sample (Clinical record #3 and #6). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The agency's complaint log was reviewed on 1/25/2021 and revealed a staff member issue (LPN-staff member #5) and a wound care issue with an attached note titled "meeting notes". The meeting notes of 12/4/2020 documented the DON (Director of Nursing) printed all the plan of cares for all the LPN's (staff member #5) patients. The DON documented the LPN notified the DON on 11/30 to report (to the physician) that the patient's (patient #3) wound had a little green around it, no odor, fever or pain. The DON asked the LPN what was she doing for the wound care and the LPN responded a wet to dry. The DON asked if the LPN got an order for that and she said no that's what we are using-we don't have the supplies. The DON asked if she checked with (agency staff) on that and the LPN stated no but that's what I am using. The DON asked the LPN if she read the plan of care and she said yes. I (DON) instructed her to notify the physician. In addition to this note the DON documented that the plan of care read to apply allevyn (hydrocellular foam pad) as wound care. The DON and LPN were not available for an interview as they do not work for the agency at this time. The clinical record for patient #3 was reviewed for the certification period of 11/11/2020 through 1/9/2021 and contained orders as follows: Wound Care Procedure: cleanse with DWC (dermal wound cleanser) pat dry then apply allevyn dressing. The clinical record failed to contain physician orders for a wet to dry dressing. 2. The clinical record for patient #6 was reviewed for the certification period of 10/28/2020 to 12/26/2020. The plan of care contained orders for wound care and read as follows: Cleanse sacral wound with DWC (dermal wound cleanser) then dampened gauze with 0.125% Dakins and apply to wound bed, cover with DSD (dry sterile dressing). The clinical record contained documentation of a wound VAC dressing applied on 11/6/2020 by a LPN (staff member #5) and wound care that read as follows: Wound cleansed with N/S (normal saline) with 4x4 gauze, wound VAC (vacuum assisted closure) applied. On 1/26/2021, at 2:30 PM the MFI asked staff member #1 where are the wound VAC orders for 11/6/2021; staff member #1 stated, I don't know. Staff member #1 did not provide the MFI an order for a wound VAC dressing. The clinical record failed to contain physician orders for a wound VAC dressing or to use normal saline to clean the wound. The above noted findings regarding the lack of documentation for treatments being administered only as ordered by a physician was reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 review of clinical records and staff interview it was determined the agency failed to document the patient's progress toward outcomes and goals specified in the plans of care for eight (8) of eight (8) clinical records reviewed in the survey sample (Clinical records: #1-8). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: The plans of care for the below noted time frame failed to contain documentation of the patient's progress toward outcomes of goals specified in the plan of care with measurable outcomes. Outcomes were generalized. 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021. The progress toward goals were generalized and were documented as follows: prevent wound infection; prevent urinary tract infection; patient is to talk to nurse instead of yelling and prevent infection. 2. The clinical record for patient #2 was reviewed for the recertification period of 11/11/2020 to 1/9/2021. The progress toward goals were generalized and were documented as follows: ongoing and wound. 3. The clinical record for patient #3 was reviewed for the recertification period of 11/11/2020 to 1/9/2021. The progress toward goals were generalized and were documented as follows: prevent wound infection; functional obesity impairment, safety and fall precautions; wound care; patient teaching on glucometer and BS (blood sugar). 4. The clinical record for patient #4 was reviewed for the recertification period of 11/17/2020 to 1/25/2021. The progress toward goals were generalized and were documented as follows: ongoing and wound care. 5. The clinical record for patient #5 was reviewed for the recertification period of 10/15/2020 to 12/13/2020. The progress toward goals were generalized and were documented as follows: per MD order educate on wound healing; diabetic skin care and discharge from agency. 6. The clinical record for patient #6 was reviewed for the certification period of 10/28/2020 to 12/26/2020. The progress toward goals were generalized and were documented as follows: ongoing and wound care. 7. The clinical record for patient #7 was reviewed for the certification period of 12/21/2020 to 2/8/2021. The progress toward goals were generalized and were documented as follows: ongoing and wound care. 8. The clinical record for patient #8 was reviewed for the certification period of 1/5/2021 to 3/5/2021. The progress toward goals were generalized and were documented as follows: ongoing. The lack of documented patient progress toward outcomes on the above noted plans of care was reviewed and acknowledged by the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 document review and staff interview, it was determined the agency failed to conduct performance improvement projects (PIP) for the year of 2019. Specifically, the agency's Quality Assessment and Performance Improvement (QAPI) documentation failed to contain evidence of the completion of at least one (1) PIP for the year of 2019. Findings: One Medical Facilities Inspector (MFI) reviewed the agency's QAPI documentation in the agency on February 2-3, 2021. The MFI requested the agency's QAPI documentation of February 2, 2021 at approximately 3:00 PM. The agency supplied documentation to the MFI at approximately 3:30 PM. Upon review, the MFI failed to find evidence or documentation that at least one PIP (performance improvement project) was conducted for the year of 2019. On February 2, 2021 at approximately 5:30 PM the MFI asked the Authorization/Scheduling Coordinator, Staff Member #7, and the Physical Therapist (PT), Staff Member #8, who was responsible at the agency for maintaining the QAPI documentation. The Authorization/Scheduling Coordinator reported that the Director of Human Resources (DHR) was responsible for maintaining the agency's QAPI documentation. On February 3, 2021 at approximately 9:30 AM the MFI interviewed the DHR, Staff Member #3, regarding the agency's QAPI. The MFI asked the DHR what PIPs the agency conducted during the year of 2019 based on the agency's needs as identified through its QAPI. The DHR stated "I am not sure." The MFI asked the DHR if the QAPI documentation furnished to the MFI contained evidence of a PIP for 2019. The DHR stated, "I am unable to say." The MFI asked the DHR if there was any additional evidence or documentation that a PIP had been conducted in 2019. The DHR confirmed there was no additional documentation or evidence. The above-noted deficiency was acknowledged during an interview with the DHR on February 3, 2021, and again during the exit conference on February 3, 2021 at approximately 5:00 PM by the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist.

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 staff observation and policy and procedure review, it was determined the agency failed to follow accepted standards of practice related to infection control and prevention; and failed to mitigate the risk of COVID-19 transmission. Specifically, agency staff failed to perform proper hand hygiene and bag technique during two (2) of two (2) on-site home visits that were completed in conjunction with the survey for patients #7 and 8. Additionally, the agency failed to develop and implement an adequate screening process for visitors to the agency. Findings: The Medical Facilities Inspectors (MFI) conducted two (2) on-site home visits with the Alternate Administrator, Staff Member #2, on February 3, 2021 at the homes of Patients #7 and #8. One (1) additional home visit was conducted remotely as a telephone interview on January 26, 2021 due to patient request. 1. The MFI conducted the home visit (patient #7) with the Alternate Administrator on February 3, 2021 at approximately 11:00 AM. Upon arrival to the patient's home, the Alternate Administrator placed the bag containing reusable equipment on an upholstered chair. After placing bag on a porous, soft surface the Alternate Administrator then proceeded to place a barrier (plastic bag) between the nursing bag and the chair. At two (2) separate points during the visit, the nursing bags fell to the floor. The Alternate Administrator failed to clean the nursing bags after their fall to the floor. During the home visit, the Alternate Administrator failed to perform hand hygiene upon entry into the patient's home and prior to initiating vital sign checks. The Alternate Administrator conducted 20 minutes of the visit prior to performing initial hand hygiene. The MFI observed the Alternate Administrator change gloves on nine (9) occasions where no additional hand hygiene was performed after removal of gloves. On three (3) separate occasions observed by the MFI the Alternate Administrator re-entered the clean area of the nursing bag without performing hand hygiene first. The MFI observed the Alternate Administrator place equipment used to assess Patient #7's vital signs, the blood pressure cuff and stethoscope specifically, back into the clean area of the nursing bag before being cleaned. 2. The MFI conducted the home visit (patient #8) with the Alternate Administrator on 2/3/2021 at 3:20 PM. During the home visit, the Alternate Administrator failed to perform hand hygiene upon entry into the patient's home and prior to initiating vital sign checks. The MFI observed the Alternate Administrator change gloves multiple times where no additional hand hygiene was performed after removal of gloves. On two (2) separate occasions observed by the MFI the Alternate Administrator re-entered the clean area of the nursing bag without performing hand hygiene first. The MFI observed the Alternate Administrator place equipment used to assess patient #8's vital signs, the blood pressure cuff, thermometer and stethoscope back into the clean area of the nursing bag before being cleaned. 3. The MFIs conducted activities in conjunction with the survey on-site at the agency on January 25 - 27, 2021 and February 2 - 3, 2021. Upon entry to the agency, the temperatures of the MFIs were obtained by facility staff, however, there was no additional screening activity conducted by the agency. According to the Centers for Disease Control and Prevention (CDC), a healthcare facility's screening procedure should include screening for the presence of lab-confirmed COVID-19 results within the previous 10 days, the presence of symptoms of COVID-19 or respiratory illness, and exposure to COVID-19 in the previous 14 days (https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html). The MFIs were not screened for these criteria at any point during on-site survey activities resulting in increased risk for the transmission of and failure to mitigate the risk of COVID-19. 4. The MFI requested the agency's policy and procedure regarding bag technique and hand hygiene on February 3, 2021 at approximately 12:00 PM from the Director of Human Resources (DHR), Staff Member #3. The DHR supplied the MFI with policies titled "Nursing Bag Technique" and "Hand Washing for Home Healthcare Personnel." The policy titled "Hand Washing for Home Healthcare Personnel," Policy Number IC-009, read in part as follows: "Personnel will wash their hands: A. After entering the patient's home, before rendering care...E. After handling contaminated materials, dressing or equipment...G. Whenever re-entering nursing bag H. If gloves are worn, hand washing must follow the removal of gloves." The policy Nursing Bag Technique read in part as follows: "The bag will be placed on a clean, hard surface (i.e.) a surface that can be easily cleaned). If only a soft surface is available a barrier will be placed under the bag...Unclean or contaminated equipment or waste of any king [sic] is not carried in the nursing bag...Hands will be washed prior to returning clean equipment to bag...Never place nursing bag on floor." The above-noted deficiency was reviewed during the exit conference with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on clinical record review, staff interview, and complaint log review, it was determined the Governing Body and/or Administrator failed to ensure the overall management and organization of resources in order to attain and provide the highest practicable functional status. The agency failed to ensure the Administrator was responsible for day-to-day operations in order for the agency to run at its highest practicable functional capacity (see G948); and the agency failed to ensure the implementation of the plan of care (see G968). The cumulative and systemic effect of the lack of the Governing Body/Administrator performing his/her role and duties resulted in the overall failure of the agency to provide quality services and negatively impacted the staff, patients, patient care, and community relationships and responsibilities.

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 clinical record reviews, staff interviews, complaint log review and observations made during a home visit, it was determined the agency failed to ensure the Administrator was responsible for all day-to-day operations of the home health agency. Specifically, the Administrator failed to ensure the agency maintained sufficient qualified staff as required to operate the home health agency. The findings: The Medical Facilities Inspector (MFI) requested to speak with the agency's Administrator on 1/25/2020 at approximately 1:30 PM during the entrance conference. The Quality Assurance Registered Nurse (staff member #1) stated the Administrator is out of the country due to quarantine. During the course of the entrance interview on 1/25/2021 the MFI asked for the agency's employee list and active patient list. The lists were provided and revealed two (2) Registered Nurses for the agency and 18 active patients. Staff member #1 stated, we have hired two new nurses but they have to be trained first. On 1/25/2021 at 1:30 PM, the Quality Assurance Registered Nurse (staff member #1) provided the complaint log to this MFI (Medical Facilities Inspector).The complaint log revealed a pattern of scheduling issues as follows: -11/23/2020 at 12:42 PM a complaint from a patient was documented regarding a LPN (staff member #4) who requested the patient to text regarding visit times but the LPN did not respond to the patient's phone and texts. The patient also complained that the LPN does not communicate and the patient never knew when the LPN was coming. - On 11/27/2020 a complaint from the same patient was documented regarding a missed LPN (staff member #4) visit. The patient also complained that the LPN never communicates and changes the schedule and requested for this LPN not to come back. -12/14/2020 a complaint from a patient (patient #1) was documented regarding missed LPN (staff member #4 and #5) visits on 4-5 consecutive Fridays and that the LPN was unable to change wound dressings. -12/17/2020 a complaint from a patient was documented regarding a missed LPN (staff member #4) visit for the day before and this day. -12/17/2020 a complaint from a patient who called four times was documented regarding a missed LPN (staff member #4) visit or communication for the day. -12/18/2020 a complaint from a patient was documented regarding a missed LPN (staff member #4) visits for 12/18/2020, 12/17/2020 and 12/16/2020. The LPN (staff member #4) was not available for interview due to his/her resignation on 12/25/2020. On 1/27/2021 at 10:00 AM the MFI asked the Director of Human Resources (staff member #3) how long has the Administrator been out of the country. Staff member #3 stated, since August or September of 2020. Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator. During the clinical record reviews several interviews were conducted with staff members #1 and #7 that revealed staffing issues. Interviews during a home visit also revealed staffing issues. It was determined that; -Patient #1 did not have a nurse who could assist with a wound care for 32 days (December 25, 2020 to January 26, 2021) and was discharged on 1/25/2021 due to "staffing issues" per staff member #1. -Patient #2 missed visits after a resumption of care (8 days) due to "LPN did not make visits" per staff member #7. -Patient #3 missed visits after a resumption of care (10 days) due to "LPN resigned" per staff member #7. -Patient #4 multiple missed visits due to "staffing issues" per staff member #1. -Patient #6 discharged per patient request "due to lack of supplies" per documentation of 12/28/2020. -Patient #7 multiple missed visits due to "LPN terminated and has not turned in visit notes" per staff member #7. -Patient #8 multiple missed visits. During a home visit with this MFI on 2/3/2021, patient #8 stated, he/she didn't know when the agency nurse was coming.. The MFI requested the agency's QAPI documentation of 2/2/2021 at approximately 3:00 PM. The agency supplied documentation to the MFI at approximately 3:30 PM. Upon review, the MFI failed to find evidence or documentation that at least one PIP (performance improvement project) was conducted for the year of 2019. On 2/2/2021 at approximately 5:30 PM the MFI asked the Authorization/Scheduling Coordinator, staff member #7, and the Physical Therapist (PT), staff member #8, who was responsible at the agency for maintaining the QAPI documentation. The Authorization/Scheduling Coordinator reported that the Director of Human Resources (staff member #3) was responsible for maintaining the agency's QAPI documentation. On 2/3/2021 at approximately 9:30 AM the MFI interviewed staff member #3, regarding the agency's QAPI. The MFI asked staff member #3 what PIPs the agency conducted during the year of 2019 based on the agency's needs as identified through its QAPI. Staff member #3 stated "I am not sure." The MFI asked staff member #3 if the QAPI documentation furnished to the MFI contained evidence of a PIP for 2019. Staff member #3 stated, "I am unable to say." The MFI asked staff member #3 if there was any additional evidence or documentation that a PIP had been conducted in 2019. Staff member #3 confirmed there was no additional documentation or evidence. The MFI requested the agency's EPP on 2/2/2021 at approximately 3:00 PM. The agency's EPP contained a document titled "Emergency Preparedness," Policy Number DC-001-A which contained the procedure for maintaining the agency's EPP testing requirements and required documentation in the following policy sections: "C. Participate in a full-scale exercise," "D. Conduct an additional exercise," and "E. Analyze the All-4-One Response." Section D of the policy read in part as follows: Analyze the All-4-One response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the All-4-One emergency plan as needed." Upon review, the MFI failed to find documentation or evidence of the testing of the EPP from 2019. The MFI asked the Authorization/Scheduling Coordinator, Staff Member #7, and Physical Therapist, Staff Member #8, who was responsible for maintaining the agency's EPP on 2/2/2021 at approximately 5:00 PM. The Authorization/Scheduling Coordinator reported that the Director of Human Resources was responsible for the agency's EPP. On 2/3/2021 at approximately 9:00 AM, the MFI interviewed staff member #3, regarding the agency's EPP. The MFI asked staff member #3 if testing of the EPP occurred during the year of 2019. Staff member #3 replied "In 2019, for new people, I just did a tabletop exercise. They take a test and they receive a certificate. During orientation I will do a mock fire-drill." The MFI asked staff member #3 if the agency participated in either a full-scale community-based or facility-based exercise, completed a tabletop exercise, or if the EPP had been activated and its response analyzed during the year of 2019. Staff member #3 stated "In 2019, I do not know if we did an exercise or not for the whole agency." The MFI asked staff member #3 to furnish any documentation or evidence that the agency's EPP was tested during 2019. Staff member #3 stated "I cannot tell you if I have anything to show the plan was activated during 2019." No additional documentation or evidence was supplied to the MFI prior to the exit conference on 2/3/2021. During the exit interview on 2/3/2021 at 5:00 PM, the Director of Human Resources, Chief Financial Officer and Scheduler acknowledged the lack of sufficient staffing negatively impacted the agency's overall organization and administration.

Assure implementation of plan of care CFR(s): 484.105(c)(5) Assuring the development, implementation, and updates of the individualized plan of care. This ELEMENT is not met as evidenced by: Based on a review of clinical records and staff interview, it was determined the agency failed to ensure that each patients' plan of care was implemented and updated as required in eight (8) of eight (8) clinical records reviewed in the survey sample (Clinical records #1, #2, #3, #4, #5, #6, #7 and #8). The findings: Eight clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2021. The plan of care contained a diagnosis of pressure ulcer of right buttock, stage 4; pressure ulcer of other site, stage 3; pressure ulcer of other site, stage 2 and orders for a Skilled Nurse (SN) to assess and evaluate pressure sores, wound care, paraplegia, colostomy, care of Foley catheter. The clinical record contained documented wound care by the skilled nurses. On 1/25/2021 at 3:00 PM the MFI asked the Quality Assurance Registered Nurse (staff member #1) where were the wound care orders? Staff member #1 provided the MFI with a prior plan of care dated 6/5/2020 that contained physician orders as follows: Wound VAC (vacuum assisted closure device to pull drainage away from wound) on ischium, white foam on undermining site at 150 HHmg [sic]. Back side apply Santyl (enzyme used to removed dead tissue) with Dakins (antiseptic) wet to dry and ABD (bulky gauze) pads. Small back site-betadine (antiseptic) cleanse with ABD. Leg site dressing with xeroform (petrolatum gauze). Foot; hydrofera blue dressing (antimicrobial foam dressing) change with 4x4 all care to be done 3 times weekly. The current plan of care failed to contain wound care orders. Additionally, the current plan of care contained orders for skilled nursing services/visits three (3) times per week for nine (9) weeks. The clinical record contained documentation of only nine (9) skilled nursing visits that were made out of 27 ordered visits. The MFI provided the above agency staff members with numerous missed visits that did not appear to be faxed to the patient's physician as evidence by no transmittal date or time on the documents. The above noted staff members acknowledged the failed missed visit documentation to the physician. 2. The clinical record for patient #2 was reviewed for the recertification period of 11/11/2020 to 1/9/2021. Skilled nursing was ordered two (2) times per week for nine (9) weeks. The clinical record contained documentation of zero (0) SN visits the week of 11/11/2020 through 11/14/2020 (week 1 for SN), A Resumption of Care (ROC) on 11/25/2020 contained orders for SN visits two (2) times per week for nine (9) weeks. The clinical record contained zero (0) SN visits the week of 11/11/2020 through 11/14/2020 (ROC week 1 for SN), Another ROC on 12/17/2020 ordered SN visits two (2) times per week for nine (9) weeks. The clinical record contained zero (0) SN visits 12/18/2020 through 12/25/2020. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 3. The clinical record for patient #3 was reviewed for the certification period of 11/11/2020 to 1/9/2021. The plan of care contained orders for a SN to cleanse with DWC (dermal wound cleanser) pat dry then apply Allevyn (hydrocellular foam pad) dressing. The plan of care failed to contain the specific location for wound care. In addition, the plan of care contained orders for skilled nursing two (2) times per week for nine (9) weeks. The clinical record contained documentation of one (1) SN visit the week of 11/11/2020 through 11/14/2020 (week 1 for SN), A ROC on 12/11/2020 ordered SN services/visits three (3) times per week for nine (9) weeks. The clinical record contained zero (0) SN visits the week of 12/13/2020 through 12/19/2020 (ROC week 1 for SN), two (2) SN visits the week of 12/27/2020 through 1/2/2021 (ROC week 3 for SN) and one (1) SN visit the week of 1/3/2021 through 1/9/2021 (ROC week 4 for SN). On 2/2/2021 at 4:15 PM the MFI asked the scheduler (staff member #7) why the patient was not seen after the ROC on 12/11/2020 for 10 days (until 12/22/2020). Staff member #7 stated, that's the week the LPN (staff member #4) resigned and missed all these visits. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 4. The clinical record for patient #4 was reviewed for the recertification period of 11/27/2020 to 1/25/2021. The plan of care contained orders for a SN to provide wound care as, dressing change for patient as per MD (Medical Doctor) order. On 1/25/2021 at 4:00 PM the MFI asked staff member #1 where are the specific wound orders? Staff member #1 provided the MFI with a physician's order dated 11/23/2020 that read as follows: Cleanse both lower leg wounds with DWC apply Alginate (absorbent dressing that protects the are from bacteria), ABD pads, 4x4's gauze secured with kerlix and tape change twice a week and prn (as needed). The current plan of care failed to contain the specific location and treatment orders for the wound care. In addition, the plan of care contained skilled nursing orders for visits three (3) times per week for one (1) week then two (2) times per week for eight (8) weeks. The clinical record contained documentation of zero (0) SN visits the week of 11/27/2020 through 11/29/2020 (week 1 for SN), one (1) SN visit the week of 11/30/2020 through 12/6/2020 (week 2 for SN) when 2 visits were ordered, one (1) SN visit the week of 12/7/2020 through 12/13/2020 (week 3 for SN) with a note in the clinical record for 12/11/2020 that stated, LPN not feeling well, one (1) SN visit the week of 12/14/2020 through 12/20/2020 (week 4 for SN) when 2 visits were ordered, one (1) SN visit the week of 12/21/2020 through 12/27/2020 (week 5 for SN) when 2 visits were ordered, zero (0) SN visits the week of 12/28/2020 through 1/3/2021 (week 6 for SN) with a note in the clinical record for 12/30/2020 that stated, patient refused wound treatment, and zero (0) SN visits the week of 1/4/2021 through 1/10/2021 (week 7 for SN) with a note in the clinical record for 1/5/2021 that stated, LPN not feeling well. The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 5. The clinical record for patient #5 was reviewed for the recertification period of 10/15/2020 to 12/13/2020. The plan of care contained orders for a SN to provide wound VAC dressing change to sacrum at 125 mmHg continuous suction Mon/Wed/Fri. On 1/25/2021 at 4:30 PM the MFI asked staff member #1 where are the specific wound dressing orders? Staff member #1 provided the MFI with a verbal order dated 10/13/2020 that contained orders as follows: 10/15/20-12/13/20 for continued wound care 3x/week for 9 weeks as ordered by physician. The plan of care failed to contain the specific treatment/dressing orders for the wound VAC dressing 6. The clinical record for patient #6 was reviewed for the certification period of 10/28/2020 to 12/26/2020. Skilled nursing was ordered two (2) times per week for one (1) week, then three (3) times per week for eight (8) weeks. The clinical record contained documentation of less than 3 visits for the following; - two (2) SN visits the week of 11/1/2020 through 11/7/2020 (week 2 for SN), - two (2) SN visit the week of 11/8/2020 through 11/14/2020 (week 3 for SN), - two (2) SN visit the week of 11/15/2020 through 11/21/2020 (week 4 for SN), - two (2) SN visit the week of 11/22/2020 through 11/28/2020 (week 5 for SN), - two (2) SN visit the week of 11/29/2020 through 12/5/2020 (week 6 for SN), and - two (2) SN visit the week of 12/13/2020 through 12/19/2020 (week 8 for SN). The clinical record failed to contain documentation that the patient's physician was notified of the visits not being provided in accordance with the patient's plan of care. 7. The clinical record for patient #7 was reviewed for the recertification period of 12/21/2020 to 2/18/2021. The plan of care did not contain wound care orders however, the DME (Durable Medical Equipment) listed wound care supplies as follows: 4x4's, wound cleanser, kerlix, Aquacel AG, border gauze 6x6. In addition, the clinical record contained wound care documentation by the skilled nurses. On 1/27/2021 at 1:00 PM the MFI asked staff member #1 where was the wound care order? Staff member #1 provided the MFI with a prior plan of care dated 10/22/2020 that contained orders as follows: SN to cleanse right anterior thigh with DWC, pat dry, apply Aquacel AG then border dressing. The current plan of care failed to contain wound care orders. 8. The clinical record for patient #8 was reviewed for the certification period of 1/5/2021 to 3/5/2021. Skilled nursing was ordered two (2) times per week for one (1) week, then three (3) times per week for eight (8) weeks. The clinical record contained documentation of only seven (7) skilled nursing visits out of 15 ordered visits. The clinical record failed to contain evidence that the physician was notified of the missed visits. The above noted findings were reviewed with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.

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 review of clinical records and staff interview, it was determined the agency failed to send the patient's discharge summary to the primary care physician within 5 business days of the patient's discharge for two (2) of six (6) discharged patients in the survey sample (Clinical records #1 and #4). The findings: Six (6) discharged clinical records were reviewed in the agency on 1/25-26/2021 with staff member #1 as the navigator and again on 2/2-2/3/2021 with staff member #7 as the navigator with the following findings: 1. The clinical record for patient #1 was reviewed for the recertification period of 12/5/2020 to 2/2/2020. The record revealed that the patient was discharged from the agency on 1/25/2021. The record failed to contain documented evidence that a discharge summary was sent to the primary physician. On 1/26/2021 at 10:30 AM it was revealed during an interview with the Quality Assurance Registered Nurse (staff member #1) the patient was discharged on 1/25/2021 without written or oral notification to the physician. 2. The clinical record for patient #4 was reviewed for the recertification period of 11/17/2020 to 1/25/2021. The record revealed that the patient was discharged from the agency on 1/13/2021. The record failed to contain documented evidence that a discharge summary was sent to the primary physician. On 1/26/2021 at 1:00 PM the MFI requested staff member #1 to provide a discharge summary. Staff member #1 stated, it is not done yet. The lack of providing a discharge summary within 5 business days of the patient's discharge was acknowledged prior to and reviewed during the exit conference with the Director of Human Resources, Chief Financial Officer, Scheduler and a Physical Therapist on 2/3/2021 at 5:00 PM.