Every finding on record at Adair Associates Inc

An Emergency Preparedness Survey was conducted by the Indiana Department of Health (IDOH) in accordance with Condition of Participation for Home Health Agencies (HHAs): 42 CFR §484.102. Survey Dates: November 17, 18, 19, 22, 23, 29, 30 (2021); and December 1, 2, 3, 6, 7, 8, 9, 13, 14, 15, 16, 17 (2021). The survey date was extended to 12/17/2021 due to the delay in receipt of information relevant to the survey process, which was requested prior to the original survey exit date on 12/15/2021. Facility Number: 157477 Provider Number: IN008247 Current Census: 106 At this Emergency Preparedness survey, At Home Quality Care was found not in compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR §484.102.

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: Based on observation, record review and interview, the agency, part of an integrated healthcare system (multiple separately licensed home health agencies that elected to have a unified and integrated emergency preparedness program), failed to ensure it maintained an agency specific comprehensive emergency preparedness program, which included an emergency plan, policies and procedures, communication plan, or testing and training program; failed to evidence the program was reviewed and/or updated as often as necessary, but at least every 2 years; and failed to evidence the patient received an individualized emergency preparedness plan for 6 of 6 home visits observed (#1, 2, 4, 6, 7, 11). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care to its patients for the Condition of Participation CFR §484.102: Emergency Preparedness for Home Health Agencies. Findings include: 1. A U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services document dated 09/2007, titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....”, was located in the agency’s home folder, which was received on 11/17/2021. This document included sections to be filled out for the patient’s allergies, medications, medical conditions, emergency contact numbers, and physician contact numbers. During an interview on 11/17/2021 at 3:15 PM, administrator A indicated all patients received a home folder during the initial comprehensive assessment/admission visit, the patient emergency preparedness plan form included was for the patients, and the form was neither individualized to the agency or completed for each patient. During an interview on 12/09/2021 at 12:41 PM, when queried if an individualized emergency plan was developed for all patients during the initial comprehensive patient assessment, clinical manager B stated “... No ....”, and indicated there were no individualized emergency plans made or given to patients. Observation during a home visit with patient #1 on 11/18/2021 at 9:00 AM, the home folder evidenced a document dated 09/2007, titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....” and was blank. Observation during a home visit with patient #2 on 11/18/2021 at 12:55 PM, the home folder evidenced a document dated 09/2007 titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....” and was blank. During a home visit observation with patient #4 on 11/18/2021 at 9:45 AM, the home folder evidenced a document dated 09/2007, titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....” This document was blank. During a home visit observation with patient #6 on 11/19/2021 at 10:30 AM, the home folder evidenced a document dated 09/2007, titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....” This document was blank. During a home visit observation with patient #7 on 11/22/2021 at 10:30 AM, the home folder evidenced a document dated 09/2007, titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....” This document was blank. During a home visit observation with patient #11 on 12/15/2021 at 10:06 AM, the home folder evidenced a document dated 09/2007, titled “Survey and Certification ... Emergency Preparedness for Every Emergency ... Emergency reference Card for Individuals with Medical Needs Living at Home ....” This document was blank. 2. During an interview on 12/09/2021 at 12:41 PM, the agency’s emergency preparedness documents/binder(s) were received and reviewed with clinical manager B and person A (corporate regulatory and resource specialist). When queried if the binders represented the complete emergency preparedness program, person A indicated the documents/binders represented the agency’s emergency preparedness program in its entirety. When queried if the agency was part of an integrated healthcare system, person A indicated they were, with agencies in Illinois and Texas. When queried if the hazards vulnerability assessment (HVA) should reflect potential hazards for this licensed agency, person A indicated it should, but did not. During an interview on 12/09/2021 at 12:41 PM, a document in the binder dated 03/2021, titled “Emergency Preparedness/Covid-19 Monthly In Service/Meeting ....” was reviewed, which failed to evidence a sign in sheet for attendees, or the time the meeting was conducted. When queried, clinical manager B indicated administrator/RN (registered nurse) A must have it. She then texted administrator/RN A, and indicated administrator/RN A responded that the documents should be in the binder. Clinical manager B then stated “... If they’re not, they might be lost ....” Upon survey exit, nothing further was submitted. During an interview on 12/09/2021 at 12:41 PM, a document in the binder dated 02/26/2021, titled “Emergency Management Plan Implementation” was reviewed, which failed to evidence who activated the plan, any minutes, updates, or after-action plan (if indicated). When queried about the document, clinical manager B indicated she and administrator/RN A activated it, it wasn’t reflected on the document, and there were no additional documents related to the plan implementation. During an interview on 12/09/2021 at 12:41 PM, a document in the binder dated 1/29/2021, titled “Table-Top Exercise #1 for 2021 ... Emergency Preparedness Updates for At Home Quality Care-Indiana” was reviewed, which failed to evidence who conducted the exercise, exercise minutes, time of meeting, sign-in list of attendees, or an after-action plan. When queried, clinical manager B indicated she and administrator A conducted the exercise, and there were no minutes, sign-in list of attendees, or an after-action plan. During an interview on 12/09/2021 at 12:41 PM, a document in the binder titled “Monthly In-Service Meeting Covid-19 Vaccination Plan ... December 7, 2020” was reviewed, which failed to evidence a sign in roster of attendees, who conducted the meeting, or the time of the meeting. When queried, clinical manager B indicated she did not have that information documented. During an interview on 12/09/2021 at 12:41 PM, an undated document in the binder titled “Infection Control Policy (update for COVID-19) ....” was reviewed, which failed to evidence a date or documentation that all staff was educated on this updated policy. When queried, clinical manager B indicated she didn’t have it. During an interview on 12/09/2021 at 12:41 PM, a document in the binder dated 03/16/2020, titled “Coronavirus Emergency Action Plan”, was reviewed, which failed to evidence documentation that all staff was educated. When queried, clinical manager B indicated she knew it was done, but there was no evidence in the binder. During this time, while reviewing the required elements of the emergency preparedness plan, clinical manager B indicated the agency’s emergency plan did not have action plans for addressing emergency events identified by the risk assessment, and she was not aware it was a required element of the plan; it did not address patient population; it did not include a process for cooperation and collaboration with local, tribal, regional, state, and federal emergency preparedness officials; it did not address the use of volunteers; and did not include names and contact information for all staff, entities who provided services under arrangement, patients' physicians, or volunteers. 3. During an interview on 12/03/2021 at 2:27 PM, clinical manager B indicated employee records failed to evidence initial or ongoing emergency preparedness training was conducted, administrator/RN A might have that documentation, and nothing further was submitted upon survey exit. 4. During an interview on 11/17/2021 at 3:50 PM, when queried if the policy binders were current, person A indicated the agency’s policy binders (located in the entrance area of the agency) didn’t contain the agency’s current/updated policies. During this time, all governing body minutes of meetings were requested for date range 01/2018, to present. A document received on 11/22/2021 at 3:03 PM, from clinical manager B, titled “Minutes of the Directors’ Meeting”, dated 11/13/2017, stated “... new emergency preparedness Plan is prepared, approved and all staff inserviced [sic] ... other requirements for the new Conditions of Participation effective on [sic] January have been or will be implemented ....” A document received on 11/22/2021 at 2:38 PM, from clinical manager B, titled “... Minutes of the Directors’ Meeting”, dated 03/13/2018, failed to evidence the agency’s emergency preparedness plan was reviewed or approved. No additional governing body meeting minutes for the remainder of 2018, 2019, 2020, or 2021 were submitted upon survey exit. 5. During an interview on 12/14/2021 at 11:14 AM, when queried to describe her involvement with the emergency preparedness program, administrator/RN A stated “... Somewhat ... we [herself, clinical manager B, and person A] talk about it ....” During this time, person A indicated the emergency preparedness program needed to be completely re-vamped, and administrator A and clinical manager B both indicated the agency’s emergency preparedness program was not current and did not reflect the needs of this agency.

This was a fully extended Federal and State Home Health Agency (HHA) Recertification/Re-Licensure Survey completed by the Indiana Department of Health (IDOH). An immediate jeopardy (IJ) was called on 12/06/2021. The administrator was notified on 12/06/2021 at 1:13 PM, regarding an IJ cited at Conditions of Participation 42 CFR §484.55: Comprehensive Assessment of Patients; and 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care. The administrator was notified on 12/15/2021 at 1:18 PM that the IJ remained unabated due to additional findings during record review for patient #11 on 12/13/2021, 12/15/2021, and completed on 12/17/2021; and findings observed during a home visit with patient #11 on 12/15/2021. Additionally, by the agency’s own admission, it failed to ensure all disciplines, including contracted staff, were re-educated on comprehensive assessment/reassessment of patients, care planning, coordination of services, and quality of care. Survey Dates: November 17, 18, 19, 22, 23, 29, 30 (2021); and December 1, 2, 3, 6, 7, 8, 9, 13, 14, 15, 16, 17 (2021). The survey date was extended to 12/17/2021 due to the delay in receipt of information relevant to the survey process, which was requested prior to the original survey exit date on 12/15/2021. Facility Number: 157477 Provider Number: IN008247 Current Census: 106 Based on the Condition-level deficiencies during the 12/17/2021 survey, At Home Quality Care was subject to a fully extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 7/27/21. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, At Home Quality Care is precluded from operating or being the site of a home health aide training and/or competency evaluation programs for the two years beginning 12/17/2021 and continuing through 12/17/2023 for being found out of compliance with the Conditions of Participation: 42 CFR §484.50 Patient Rights; 42 CFR §484.55: Comprehensive Assessment of Patients; 42 CFR §484.58: Discharge Planning; 42 CFR §484.65: Quality assessment and performance improvement (QAPI); 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care; 42 CFR §484.105: Organization and Administration of Services; and 42 CFR §484.110: Clinical Records. Quality Review Completed 02/24/2022

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 observation, record review, and interview, the agency failed to ensure all patients received an OASIS (Outcome and Assessment Information Set) privacy notice for all patients for whom the OASIS data was collected, prior to furnishing care/services (See G416); failed to ensure all patients received the agency’s information on how to make a complaint (See G432); failed to ensure all patients and/or family/caregivers were informed about, and participated in deciding what services/care was furnished based on the comprehensive assessment, and/or the frequency of visits (See G434); failed to ensure all patients received the name, address, and telephone number of the current federally funded Quality Improvement Organization (QIO) prior to furnishing care/services (See G446); failed to ensure all patients received information on auxiliary aids and language services, or how to access these services (See G450); and failed to ensure all patients received the agency’s discharge policy (See G452). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.50: Patient rights. 17-12-3(b)(2)(B) 17-12-3(b)(2)(C) 17-12-3(b)(2)(D)(i)(AA) 17-12-3(b)(2)(D)(i)(BB)

OASIS privacy notice CFR(s): 484.50(a)(1)(iii) (iii) An OASIS privacy notice to all patients for whom the OASIS data is collected. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients received an OASIS (Outcome and Assessment Information Set) privacy notice for all agency patients for whom the OASIS data was collected, prior to furnishing care/services. Findings include: An undated agency document received on 11/17/2021, titled “At Home Quality Care Consent for Home Health Care Services and Agreement” stated “... OASIS DATA COLLECTION ... I hereby authorize ... [agency ... to administer and reporting of OASIS DATA SET ....” During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet and all enclosed documents were reviewed. Administrator/RN (registered nurse) A indicated this admission packet was given to all patients upon admission. When queried if an OASIS privacy notice was included in the packet, she indicated it was not.

Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all agency patients received the agency’s information on how to make a complaint. Findings include: An undated agency document received on 11/17/2021, titled “At Home Quality Care Consent for Home Health Care Services and Agreement” stated “... Patient Rights and Responsibilities ... I have been informed of the grievance/complaint procedure ... I will try to resolve the complaint with my primary nurse, his/her supervisor before contacting the state hotline .... You Have the Right to ... Make complaints ....” An undated document received on 11/17/2021, titled “[home health agency II] Home Health Professionals ... Complaint Form ....” evidenced it was a different agency’s complaint form. During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet and all enclosed documents were reviewed. When queried, administrator/RN (registered nurse) A indicated this admission packet was given to all patients upon admission. When queried who home health agency II was, clinical manager B indicated it was the company the agency bought out. 17-12-3(b)(2)(B)

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 observation, record review, and interview, the agency failed to ensure all patients and/or family/caregivers were informed about and participated in deciding what services/care was furnished based on the comprehensive assessment, and/or the frequency of visits for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2015, titled “Home Health Patient Bill of Rights” stated “... defines the right of the patient to ... Be informed ... about care to be furnished ... disciplines that will furnish care ... frequency of visits proposed to be furnished ... the right to participate in planning the care ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment ... for each patient ... including ... at least the following ... Patient and family/caregiver support ... and the type of care the family/caregiver ... provide ...Involvement of ... family/caregiver ... or organizations ....” 3. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Functional Assessment” stated “... appropriate assessment of patient who may have functional limitations requiring assistance and services from the ... [agency] ... including but not limited to ... Eating ... Toileting ... Transfers ... Bathing ... Dressing ... Mobility status ... Problems with continence [control of bowel and/or bladder] ... Based on the above ... determine which additional services ... the patient may benefit from, including home health aide [HHA] ....” 4. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer of left buttock, and other diagnosis stage 2 pressure ulcer of right buttock, evidenced a document dated and signed on 10/29/2021, by registered nurse (RN) G, titled “... Recertification [comprehensive reassessment] ....” This document evidenced the patient was incontinent of bowel and bladder, disoriented, dependent for toileting, unable to transfer self, unable to perform hygiene tasks without assist from another person, chairfast, unable to feed self without set-up, lived in an assisted living facility (ALF), and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. A home visit was observed on 11/18/2021 at 9:00 AM, with licensed practical nurse (LPN) H present. The patient presented sitting in a chair with her eyes closed. She was difficult to rouse, and required agency nurse with 1 ALF Q staff to transfer the patient from the chair to her bed for wound care. During this time, when queried about the patient’s condition, LPN H indicated the patient would sometimes follow commands, she couldn’t stand up anymore, she was incontinent of bowel and bladder, and she did not perform her own personal care. 5. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, primary diagnosis dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) (surgically inserted on 9/21/2021), evidenced a document dated and signed by RN I on 09/24/2021 titled “... Start of Care [comprehensive assessment] ....” This document indicated the patient was incontinent of bladder, needed assistance for personal care/hygiene, needed assistance for transfers, assistance to eat, indicated the patient and daughter agreed to skilled nursing one time the first week, twice a week for 1 week, then weekly for 7 weeks, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. During an interview on 12/01/2021 at 1:35 PM, a family member indicated she did not know the agency offered HHA services, she would like the help, but wasn’t sure if her parent (patient) would allow someone else to help. 6. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis Alzheimer’s disease, evidenced a document dated 08/20/2021 and signed by PT [physical therapist] J on 08/30/2021, titled “... PT Start of Care [comprehensive assessment] ....” This document evidenced the patient resided at ALF Q, required another person to bathe/shower, and failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. 7. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis Alzheimer’s disease (unspecified), evidenced a document dated 10/29/2021, and signed by PT J on 11/02/2021, titled “... PT Start of Care ....” This document indicated the patient lived in an ALF, was incontinent of urine, required assistance of another person to perform dressing, grooming, showering, toileting, transferring, was unable to feed self, and failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. A home visit was observed on 11/18/2021 at 9:45 AM, with PT M. The patient presented sitting in a chair, eyes closed, with a plate of food in front of her, a full glass of juice, and several food particles on her clothing. When queried if the patient needed help to eat, PT M indicated she probably needed help. 8. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, primary diagnosis type 2 (adult onset) diabetes with foot ulcer (open wound), evidenced a document dated and signed by administrator/RN A on 09/08/2021, titled “... Start of Care ....” The document indicated the patient lived in an ALF, was confined to a chair, had a right above knee amputation, required assistance for dressing and bathing, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. 9. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), and personal history of COVID-19 (04/27/2021), evidenced a document dated and signed on 10/22/2021, by RN I titled “... Recertification ....” This document indicated the patient had 4 or more stasis ulcers (wounds caused by impaired circulation), resided at ALF L, and previously lived at home, had a fall which resulted in a brain injury, needed assistance from another person for dressing, bathing and transferring, needed help with meal set up/clean up, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. 10. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), secondary diagnoses included non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, evidenced a document dated and signed on 10/26/2021, by RN G titled “... Recertification ....” This document indicated the patient’s dietary intake was probably inadequate, was a nutritional risk, resided at ALF L, needed help from another person to groom, dress, bathe and transfer, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. 11. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis unspecified open wound, right lower leg, subsequent encounter, secondary diagnoses unspecified open wound, left lower leg, subsequent encounter, unspecified juvenile rheumatoid arthritis, essential (primary) hypertension (high blood pressure), unspecified urinary incontinence, and history of falling, evidenced a document dated and signed on 06/09/2021, by administrator/RN A titled “... Recertification ....” This document evidenced the patient was chairfast (ability to walk severely limited or non-existent, could not bear own weight and/or must be assisted into chair), he was oriented, continued to have multiple falls, needed skilled nursing for wound care, lived at ALF Y, incontinent of bladder, needed assist from another person to dress, bathe and toilet, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. 12. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, which evidenced a document dated and signed on 04/30/2021, by administrator/RN A titled “... Start of Care ....” This document indicated the patient needed assistance for all activities, assistance needed for grooming, dressing, bathing and toileting, transferring, assistance with meals, skilled nursing visits were once weekly, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. During an interview on 12/02/2021 at 1:56 PM, when queried about the services the agency offered and the patient received, family indicated the patient got progressively worse, the last couple times he took her to the bathroom, she collapsed, he would have liked more than 1 nursing visit weekly, but he just went with what they said, the patient did not receive HHA services, and the agency told him Medicare wouldn’t pay for it (HHA services). 13. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, bed confinement status, evidenced a document dated and signed by RN I on 11/07/2021 titled “... Start of Care ....” This document evidenced the patient’s payor source was Medicare (HMO/managed care/Advantage plan), the patient was bedbound, skin was constantly moist, completely immobile, did not make even slight changes in position, was incontinent of bowel and bladder, was dependent for all care, dependent for meals, skilled nursing was ordered 4 times the first week, then 3 times per week for seven weeks, then twice per week for 1 week, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. During an interview on 12/02/2021 at 1:16 PM, when queried who bathed the patient, family indicated she and her other parent did, and they (agency) said insurance wouldn’t pay for someone to help clean her (patient). When queried if the nurse ever discussed options for how often a nurse could come, or patient/family preferences, family stated “... No ....” During this time, she also indicated they never offered HHA services, and she would want one. During an interview on 12/13/2021 at 1:46 PM, when queried why family was told insurance wouldn’t pay for HHA services, and did the record reflect this, clinical manager B did not respond as to why family was told that and indicated the record did not evidence insurance wouldn’t pay for HHA services. When queried if the patient would have benefited from home health aide services, clinical manager B stated “... Yes ....” 14. Record review for patient #11 was completed on 12/15/2021, start of care 12/07/2021, certification dates 12/07/2021 – 02/04/2022, primary diagnosis pressure ulcer of sacral (lower back) region, unstageable, other diagnoses pressure ulcer of left buttock, unstageable, cellulitis of lower limb, and unspecified dementia without behavioral disturbance, evidenced a document dated and signed on 12/07/2021, by RN G. This document evidenced the patient resided at ALF K, she was oriented but forgetful, confused in new or complex situations only, but then indicated patient failed to recognize familiar persons/places, inability to recall events of last 24 hours, significant memory loss so that supervision was required, had open, draining wounds, was totally dependent for all care and meals, was chairfast, and stated “... Does this patient require HHA services? ... [box checked] ... No ....” The document failed to evidence if HHA services were offered and/or declined, or how the patient’s personal care needs were met. A home visit was observed on 12/15/2021 at 10:06 AM, with administrator/RN A and RN G. Surveyor P was also present. The patient presented lying in bed. Observed extensive tooth decay/very poor oral hygiene, matted/tangly hair on head, very dry, scaly skin on legs, the patient had an incontinence brief on, and she had extensive, severe wounds. 15. During an interview on 11/17/2021 at 10:42 AM, when queried if the agency provided home health aide services, administrator /RN A indicated the agency did, but they did not currently have any aides employed. When queried if there were services the agency had trouble staffing, and how it was handled, administrator /RN A indicated the agency had trouble staffing home health aides, they weren’t actively trying to hire aides, they would try and have a nurse or occupational therapist (OT) provide the service, and if they couldn’t staff the need, they didn’t accept the patient for care/services. 16. During an interview on 12/3/2021 at 12:42 PM, clinical manager B indicated the agency hasn’t had home health aide services for “a long time”. 17-12-3(b)(2)(D)(i)(AA) 17-12-3(b)(2)(D)(i)(BB)

State toll free HH telephone hotline CFR(s): 484.50(c)(9) Be advised of the state toll free home health telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints or questions about local HHAs. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all agency patients were advised of the Indiana Department of Health’s (IDOH) toll free home health hotline telephone number, contact information, or hours of operation. Findings include: An undated agency document received on 11/17/2021, titled “At Home Quality Care Consent for Home Health Care Services and Agreement” stated “... Patient Rights and Responsibilities ... I will try to resolve the complaint with my primary nurse, his/her supervisor before contacting the state hotline ... Be advised of the state toll free home health telephone hot line, its contact information, its hours of operations ....” The document failed to evidence IDOH’s toll free home health hotline telephone number, contact information, or hours of operation. An undated document received on 11/17/2021, titled “[home health agency II] Home Health Professionals ... Complaint Form ....” evidenced it was a different agency’s complaint form, included an illegible state hotline number, and indicated hours of operation were 24 hours per day, 7 days per week. During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet and all enclosed documents were reviewed. When queried, administrator/RN (registered nurse) A indicated this admission packet was given to all patients upon admission. After review of the document titled “[home health agency II] Home Health Professionals ... Complaint Form ....” clinical manager B was queried who home health agency II was. Clinical manager B indicated it was the company the agency bought out. When queried if the document was legible, or referenced IDOH, clinical manager B indicated it was a bad photocopy, and IDOH information was not anywhere else in the admission packet. 17-12-3(b)(2)(C)

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all agency patients received the name, address, and telephone number of the current federally funded Quality Improvement Organization (QIO) prior to furnishing care/services. Findings include: An undated agency document received on 11/17/2021, titled “At Home Quality Care Consent for Home Health Care Services and Agreement” stated “... As a Patient You Have The Right To ... Be advised of the names, addresses, and telephone numbers of the following Federal-funded ... entities that serve the area where the patient resides ... Quality Improvement Organization ....” An untitled, undated agency document received on 11/17/2021, evidenced a list of federal and state funded agencies, including QIO HH (no longer federally contracted for Indiana residents), and failed to evidence the name, address, and telephone number of the current federally funded QIO. A web-based site, referenced on 11/17/2021 at 2:55 PM, at https://www.livantaqio.com/en/states/indiana, indicated Livanta was the current Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) for patients who resided in Indiana. During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet and all enclosed documents were reviewed, which included the untitled, undated agency document that listed federal and state funded agencies. When queried, administrator/RN (registered nurse) A indicated this admission packet was given to all patients upon admission. When queried what entity was the current QIO for patients who resided in Indiana, person A (corporate regulatory and resource specialist), administrator/RN A, and clinical manager B indicated they were not aware QIO HH was not the current QIO.

Access to auxiliary aids and language service CFR(s): 484.50(c)(12) Be informed of the right to access auxiliary aids and language services as described in paragraph (f) of this section, and how to access these services. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients received information on auxiliary aids and language services, or how to access these services. Findings include: An undated agency document received on 11/17/2021, titled “At Home Quality Care Consent for Home Health Care Services and Agreement” stated “... As a Patient You Have The Right To ... be informed of the right to access auxiliary aides and language services and how to access these services ....” During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet and all enclosed documents were reviewed. When queried, administrator/RN (registered nurse) A indicated this admission packet was given to all patients upon admission. When queried if auxiliary aides and language services information was included, and the process to access it, administrator/RN A indicated it was not.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure all patients received the agency’s discharge policy. Findings include: An undated agency document received on 11/17/2021, titled “At Home Quality Care Consent for Home Health Care Services and Agreement” stated “... As a Patient You Have The Right To ... receive a copy of the home health agency’s policies for transfer and discharge ....” During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet and all enclosed documents were reviewed. When queried, administrator/RN (registered nurse) A indicated this admission packet was given to all patients upon admission. When queried if the agency’s discharge policy was evidenced in the packet, person A (corporate regulatory and resource specialist)A indicated it was not.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: An immediate jeopardy (IJ) related to the comprehensive assessment and re-assessment of patients was identified on 12/06/2021. The administrator was notified on 12/06/2021 at 1:13 PM. The immediate jeopardy remained unabated upon the survey exit on 12/15/2021, due to an additional record review with a home visit observation that was completed on 12/17/2021, for a newly admitted patient (#11), start of care 12/7/2021, primary diagnosis unstageable pressure ulcer of sacral (lower back) region, and other pertinent diagnoses of unstageable pressure ulcer of left buttock, and cellulitis of left lower limb, who received skilled nursing services for wound care, and evidenced the patient developed new and worsening wounds after the start of care, developed wound infection which required oral antibiotic treatment, failed to evidence the registered nurse (RN) correctly documented the location of the unstageable pressure ulcer of the buttock, which was on the right, not left, assessed the patient’s left lower leg (for documented diagnosis of cellulitis, or the patient’s pain was comprehensively assessed. Additionally, the physical therapist (PT) failed to ensure the comprehensive assessment was completed within 5 calendar days after the start of care (See tag G520); the comprehensive assessments included patients' current health, psychosocial, and/or cognitive status (See tag G528); included strengths, goals and care preferences, and/or the progress toward the achievement of those goals (See tag G530); the patient’s comprehensive assessment included patient specific discharge planning needs (See G534); the registered nurse (RN) failed to perform a drug regimen review (DRR), and/or identified any major drug reactions (See tag G536); the registered nurse (RN) and/or physical therapist (PT) failed to ensure the comprehensive assessment included the patient’s primary caregiver’s (and/or other available supports) willingness, ability to provide care, and/or their availability (See tag G538); completed updated comprehensive re-assessment for worsening in health status (See tag G544); and completed updated comprehensive re-assessment as frequently as the patient’s condition warranted (See tag G548). This practice had the potential to affect all agency patients. 17-14-1(a)(1)(A) 17-14-1(a)(1)(B) The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.55: Comprehensive Assessment of Patients. Based on observation, record review and interview, the home health agency failed to ensure the RN assessed / re-assessed patients who were reported to have a change in condition. The failure to complete a comprehensive assessment resulted in new and/or worsening symptoms, new and/or worsening wounds, wound infections, aspiration pneumonia and multiple hospitalizations. Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The initial assessment must be performed ... within 48 hours of the referral ... within 48 hours of the patient’s return home [after a hospital stay] ... the assessment will be patient specific and comprehensive ... will be completed ... [for] ... Significant change in condition ... Within 48 hours of the patient’s return home from a 24-hour hospital admission ... must be conducted by a registered nurse ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Ongoing Assessments” stated “... Re-assessments should focus on ... Changes in patient condition ....” 3. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Reassessments/Recertification” stated “... The comprehensive assessment must be updated and revised ... at least every 60 days, or more often as warranted by the condition of the patient ... assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician ... will be completed within the mandated timeframes ... must include ... any changes in patient status ....” 4. A Johns Hopkins web-based reference, https://www.hopkinsmedicine.org/gec/series/wound_care.html, reviewed on 12/15/2021, titled “Wound and Pressure Ulcer Management”, stated “... [pressure ulcer] ... Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed ... Measurement ... Length – from top edge to the bottom edge (head to toe) at longest point ... Width – from edge to edge perpendicular to the length at widest point ... Depth – straight in, perpendicular to the base, at deepest point ... Necrosis/Eschar - Black, brown or tan devitalized tissue that adheres to the wound bed or edges and may be firmer or softer than the surrounding skin ... Slough - Soft, moist avascular tissue that adheres to the wound bed in strings or thick clumps; may be white, yellow, tan or green ....” 5. A Drugs.com web-based reference, https://www.drugs.com/cdi/calmoseptine.html, reviewed on 12/15/2021, stated “... Calmoseptine ... It is used to protect skin from wetness, urine, or stools ... to treat diaper rash ... to treat minor cuts, scrapes, or burns ... Do not put on open or deep wounds ... infections ....” 6. A Centers for Disease Control and Prevention web-based reference, https://www.cdc.gov/groupastrep/diseases-public/Cellulitis.html, reviewed on 12/15/2021, stated “... Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin. If untreated, it can spread and cause serious health problems. Good wound care and hygiene are important for preventing cellulitis ....” 7. Record review for patient #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer (wound caused by unrelieved pressure, no deeper than the layers of the skin, and includes intact or ruptured blisters) of left buttock, and other pertinent diagnosis stage 2 pressure ulcer of right buttock, evidenced a comprehensive assessment dated and signed by RN G on 10/29/2021, titled “... Recertification ....”, which evidenced the patient had a wound on the right (R) buttock, it measured 3.0 cm (centimeters) (in length) x (by) 0.5 cm (wide) x /= (greater than or equal to) the diameter of a quarter (2.5 cm), the depth was approximately >/= the diameter of a quarter, there was undermining present at the top of the wound, a large amount of thick, creamy drainage was present, and the patient yelled out in pain during wound care. During this time, LPN H indicated alternate clinical manager A was the RN case manager, the wound wasn’t doing any better, and the wound appeared more necrotic (dead, black tissue) than before. During an interview on 11/30/2021 at 1:30 PM, when asked, clinical manager B indicated the RN supervisor should be notified for signs/symptoms of infection, new or worsening wound(s), and an RN should follow up on antibiotic efficacy. When asked at what point would the RN go back out to assess the worsening wound(s), clinical manager B indicated it should have occurred on the next visit after the antibiotics were ordered, and when asked if an RN did a follow up re-assessment, clinical manager B stated “... No ....”, and indicated the last RN visit was 10/29/2021 (for the recertification comprehensive assessment). During an interview on 12/07/2021 at 10:50 AM, with regard to the nursing visit completed on 11/12/2021 by LPN H, alternate clinical manager A indicated LPN H documented the wound was worse, and even if the wound bed was worse, the wound was decreasing in size, so she wasn’t sure why an RN would need to go out to re-assess the patient, and asked how quickly a nurse was expected go back and assess a patient. Additionally, she indicated the antibiotics were ordered on the 11/17/2021, and clinical manager B indicated the antibiotics were actually ordered on 11/15/2021. 8. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, primary diagnosis dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) on 9/21/2021, encounter for attention to gastrostomy (g tube), atherosclerotic heart disease (hardening of the arteries), hypertensive chronic kidney disease (high blood pressure caused by the narrowing of your arteries that carry blood to your kidneys), end stage renal disease (kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life), dependence on dialysis, and history of old myocardial infarction (heart attack) and coronary angioplasty (a medical procedure in which a balloon is used to open a blockage in an artery in the heart); and certification period 11/23/2021 – 1/21/2021, primary diagnosis pressure ulcer of sacral (lower back) region on 11/02/2021, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) on 11/02/2021, dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) on 11/02/2021, and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) on 10/12/2021. A document dated and signed by RN I on 9/24/2021 titled “... Start of Care ... [initial comprehensive assessment] ....” evidenced the patient was able to take in nutrients orally, received supplemental tube feedings, received some medications via g tube, was on a renal diet (low in sodium, phosphorous, and protein, and also emphasizes the importance of consuming high-quality protein, and usually limiting fluids) with 1500 ml (milliliter) fluid restriction, received 8 ounces of Nepro (supplemental feeding) via g tube QID (4 times daily); and failed to evidence the nurse assessed the patient's ability to swallow food or fluids to determine active aspiration, assessed correct placement of the g tube, checked for gastric residual, or assessed patient/caregiver competency for administration of supplemental feedings and medications administered via g tube. Documents dated and signed by RN I on 9/28/2021 and 9/30/2021, titled “... SN Visit Note” failed to evidence the nurse assessed the patient's ability to swallow food or fluids to determine active aspiration, assessed correct placement of the g tube, checked for gastric residual, or assessed patient/caregiver competency for administration of supplemental feedings and medications administered via g tube. The document dated and signed by RN I on dated 9/30/2021 titled “... SN Visit Note” also evidenced the patient complained of nausea/vomiting, and failed to evidence the nurse informed the clinical supervisor or physician. Hospital D documentation dated 10/12/2021 evidenced the patient was hospitalized on 10/04/2021 for nausea/vomiting due to tube feedings and hyponatremia most likely secondary to excessive free water flushes with tube feeds and was ordered NPO (take nothing orally/by mouth), and was discharged to home on 10/08/2021. A document dated and signed by RN I on 10/12/2021 titled “... Resumption of Care ....” (comprehensive assessment) evidenced the physician ordered the resumption of care to be completed on 10/12/2021, the nurse assessed crackles in the patient’s lower lungs (the small air sacs in the lungs fill with fluid), she had shallow breathing, and failed to evidence the physician was notified of the assessment findings. During an interview on 12/07/2021 at 1:54 PM, when asked why the resumption of care (comprehensive assessment) occurred 4 days after the patient was discharged from the hospital on Friday, 12/08/2021, alternate clinical manager A stated, “ I don’t think we even knew she was home ....”, and indicated she faxed (hospital D) on Monday, 10/11/2021 for patient’s hospitalization records, received them on 10/12/2021, and office assistant D called the hospital every day to check status. During this time (2:49 PM) office assistant D indicated she didn’t call every day, and alternate clinical manager A indicated they didn’t check patient status on weekends. When asked why the comprehensive assessment dated 10/12/2021 indicated the physician ordered the resumption of care to occur on 10/12/2021, the clinical and alternate clinical managers both indicated they didn’t know. A document dated and signed by RN I on 10/14/2021 titled “Missed visit Note” evidenced the family requested cancellation of nursing visit same date due to multiple other agency disciplines’ visits scheduled for same day, and the patient had dialysis on 10/15/2021. The document failed to evidence a visit was offered for another day of that work week. A document dated and signed by RN I on 10/19/2021, visit time 12:30 PM – 1:30 PM, titled “... SN Visit Note”, evidenced the patient did not go to dialysis this date due to fatigue, nurse assessed “significant decline in respiratory status”, “ patient’s respiratory status declining”, nurse requested for family to transport to ED (emergency department), but family indicated she would take the patient to urgent care. A document dated and signed by occupational therapist (OT) K on 10/19/2021, visit time 1:35 PM – 2:20 PM, titled “... OT Eval and CP [care plan]” evidenced the patient’s respirations were regular, the patient was stable, and failed to evidence the patient exhibited any respiratory complications. During an interview on 12/08/2021 at 9:55 AM at dialysis center F, an untitled dialysis calendar was submitted by facility staff G, which evidenced the patient was not scheduled for dialysis on 10/19/2021, and her regular schedule was every Monday, Wednesday, and Friday. A document dated and signed by RN I on 10/22/2021 titled “... SN Visit Note” evidenced a nursing visit was made from 12:30 PM – 1:00 PM, evidenced the patient had increased weakness, nausea and vomiting, shortness of breath with onset of productive cough with copious amounts of mucus, and family was going to take the patient to urgent care. During an interview on 12/08/2021 at 12:52 PM, urgent care H staff I indicated the patient was checked in at the facility on 10/22/2021 at 1:07 PM, and was sent to the ED at 1:35 PM. During an interview on 12/08/2021 at 11:00 AM, family indicated RN I did not make a nursing visit on 10/22/2021, no one was there that day, which evidenced a text from RN I on 10/21/2021 at 2:44 PM that stated “ ... I’ll see you guys next week”, a text message on 10/22/2021 at 9:14 AM from family to RN I which stated, “Rough morning as soon as the food hit her stomach she started vomiting ....”, a text message from RN I to family at 11:45 AM which stated “Were you able to get in touch with md [sic]?” and a text message from family to RN I at 2:09 PM which stated “At the ER [emergency room] doctor said her lungs are horrible ....” A hospital D document (part of agency record) titled “History and Physical Reports” evidenced the patient was admitted 10/22/2021, discharged on 10/31/2021. Hospital paperwork indicated family needed to be taught how to do tube feeds properly and prevent any further aspiration. A text message was sent from family to RN I on 11/10/2021 at 8:38 AM which stated “Well we are back to square one. She woke me up at 5am gave her 2 oz [ounces] formula tylenol [sic] and her new nausea medicine it no more hit her stomach and she vomited it all up. She is coughing a lot [sic] and doesn’t want to go to dialysis.”, a text from RN I to family at 8:50 AM which stated “... I just want her comfortable and it kills me we can’t help her”, and additional texts that indicated the patient didn’t want to go to the ED, the nurse indicated family could ask for a suppository for the nausea, asked family if the patient was still having rib cage and back pain, and failed to evidence the nurse asked to make a home visit to assess the patient, or offered to contact the physician. On Thursday, 11/11/2021 at 8:00 AM, family texted RN I to inform her the patient was at the ED (hospital D), and she returned home the same day with new medication orders. On Wednesday, 11/17/2021 at 12:25 PM, RN I texted family and stated “So there is a [sic] Indiana state surveyor here doing a survey for At Home Quality Care ... You do not have to say yes it’s your choice”, a text from family to RN I at 12:30 PM which stated, “Yes that [sic] fine”, and a text from RN I to family at 12:32 PM from RN I to family at 12:32 PM which stated “Do you care if I stop over today just to look at the [home] folder? I have to make sure the medication sheets and plan of care are n [sic] there and ... vital signs so we pass the survey ....” The clinical record failed to evidence the RN made another home visit after 11/09/2021 until 11/18/2021. A home visit observation occurred on 11/18/2021 at 12:55 PM with RN I present. This was a recertification comprehensive assessment visit. The patient presented seated upright in a living room chair, was coughing uncontrollably, tears streamed down her face, and family indicated she just had some sips of hot cocoa. During this time, RN I assessed crackles in bilateral lung bases, and indicated she would refer SLP (speech language pathologist) services to evaluate (SLP was not referred upon start of care on 9/24/2021), indicated the agency did not offer social worker services, it would be nice, there were lots of needs for social work services, the patient didn’t have any current open skin areas, she had an open area on her coccyx around the end of October, but it was resolved, and family used desitin (diaper rash ointment) as a preventative. When the nurse was asked to assess the patient’s coccyx near the end of the visit, a stage 2 pressure ulcer was observed, approximately the size of a quarter, with a small amount of yellow slough on part of the wound bed. The nurse indicated she would notify the physician and get an order for mepilex (foam dressing), and she would stop by the patient’s home tomorrow (11/19/2021) to drop off wound supplies. During this time, family indicated the nurse never watched her administer tube feedings or administer medications, she was never told the patient had a fluid restriction, or have nothing by mouth, and she finished a course of antibiotics on 11/14/2021. The clinical record evidenced a nursing visit was made on 11/19/2021 by RN I from 3:15 PM – 4:00 PM, and vital signs and other physical assessments were performed. During an interview on 12/08/2021 at 11:00 AM, family indicated RN I did stop by on 11/19/2021, but she just did the dressing and left. When asked if she checked the patient’s vitals or performed any other assessments on the patient, family indicated she did not. During an interview on 12/1/2021 at 1:35 PM, family indicated she informed the registered nurse on 11/21/2021 that the patient's blood pressure was “running high”, the nurse did not make a visit to assess the patient, the nurse texted to check on the patient's blood pressure on 11/22/2021, during which time family indicated she didn't write her blood pressure readings down, indicated to the nurse "something has changed, we took a big step backwards", the nurse did not make a home visit to assess the patient, and the patient was subsequently seen in the ED, hospitalized 11/24/2021- 11/25/2021 for hypertension and NSTEMI (a type of heart attack involving partial blockage of one of the coronary arteries) with stent placement. At that time, the nurse texted back to have family let her know when the patient got home. On 11/27/2021, family texted the nurse to inform patient was home from hospital, and the nurse replied to let her know when she'd like a visit, but did not offer to visit on that date. When asked if she would have accepted a visit from the nurse if she offered to come on 11/27/2021, family said "Of course". As of 12/1/2021, the patient was not seen by the nurse or SLP. During an interview on 12/3/2021 at 12:42 PM, when asked if the agency “front loaded” nursing visits (an increased nursing frequency of weekly visits based on patients who had complex and/or high-risk needs), the clinical manager stated “Yes ....”, and indicated it was based on diagnosis, high- tech needs such as IV (intravenous) treatment, wound vac (complex negative pressure wound therapy), or CHF (congestive heart failure). When asked if g tube patients were front loaded, she indicated it would depend on if the patient/family already knew how to care for it. When asked if a patient would be front loaded for a patient with a new g tube, such as 3 days old should be front loaded, she stated “Yes, definitely.” During an interview on 12/07/2021 at 10:50 AM, as a result of the immediate jeopardy (IJ) announced on 12/06/2021, clinical manager B indicated she wanted to discuss patient #2, and asked alternate clinical manager A to “take over the conversation”, as she knew the patient better. Alternate clinical manager a did not respond, and when asked again by the clinical manager, the alternate clinical manager did not respond. Clinical manager B then indicated that when she previously indicated the patient should have been front loaded, she thought it was important to note the patient went to dialysis 3 times per week. Alternate clinical manager A then indicated family said she didn’t want the patient to be seen over the holiday weekend (11/25/2021 -11/28/2021), and the patient was non-compliant with attending dialysis. When asked why the patient was non-compliant, she indicated she didn’t know. The clinical record failed to evidence the nurse attempted to schedule a visit 11/25/2021 – 11/28/2021, or evidenced the patient/family declined a visit during same timeframe. During an interview on 12/08/2021 at 9:55 AM at dialysis center F, facility staff G indicated the patient was not non-compliant with receiving dialysis treatments. 9. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow) and dependence on supplemental oxygen, evidenced a comprehensive assessment dated and signed by RN G on 10/26/2021, titled “... Recertification ....” document evidenced 2 wounds: a stasis ulcer (L) leg, black wound bed, (4.0 cm x 3.0 cm x 0.3 cm), no odor; and an open wound (L) leg, pale pink wound bed, (2.1 cm x 1.6 cm x 0.3 cm) small amount serosanguinous drainage, no evidence of infection documented, assisted living facility (ALF) L was not permitted to perform wound care, pain rated by patient as “8” in (L) leg, and stated “... numeric [pain] scale ... 0: None ... 7-9: requires MD [physician] intervention ....” The document also evidenced the patient took tylenol every 6 hours for pain, and failed to evidence the nurse assessed the patient’s last dose of tylenol. A document dated and signed by LPN E on 11/01/2021 titled “... SN Visit Note” evidenced the (L) leg stasis ulcer and (L) leg open wound morphed into one larger wound (7.0 cm x 4.0 cm x 0.3 cm), (L) leg calf edema (swelling), which measured 14 inches diameter, skin was shiny and pale around the wound; and an open wound to shin continued (without orders to treat). A document dated and signed by LPN E on 11/03/2021 titled “... SN Visit Note” evidenced the calf edema increased to 15 inches diameter, the (L) leg dressing was saturated with drainage, the wound declined, patient had increased pain, was sent to ED for evaluation. A hospital D document dated 11/04/2021 titled “History and Physical Reports” evidenced the patient was admitted on 11/03/2021 discharged on 11/08/2021, evidenced the patient complained of increased pain, redness and swelling to (L) lower leg, which spread up back of leg, for 2 days; and was admitted with cellulitis which required treatment with intravenous (IV) antibiotics. The document also evidenced the patient was a current daily beer drinker. A hospital D document dated 11/08/2021 titled “Discharge Documentation” evidenced the patient’s new medications included Levaquin (antibiotic) orally for 7 days, and tramadol (pain medication) every 6 hours as needed for pain. A document dated and signed by alternate clinical manager A on 11/09/2021 titled “... Resumption of Care ....” evidenced no wound orders were sent home with the patient from hospital D, she was unable to obtain orders, so she covered the wounds with dry gauze and wrapped the wounds with gauze rolls, and the patient had an appointment at wound clinic M on 11/11/2021. Additionally, the patient’s stated pain was “7”, (L) lower leg wound (8.0 cm x 5.1 cm x 0.3 cm), wound bed brown, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed pale pink, and 0.5 cm x 2.0 cm x 0.1 cm), no wound bed description, both had drainage; and stated “... Patient has been found with a lot of beer in her room and has become a concern to facility ....” The document failed to evidence the nurse assessed how much beer the patient regularly consumed or a comprehensive assessment of the patient’s pain. A document dated and signed by LPN E on 11/10/2021 titled “... SN Visit Note” evidenced (L) lower leg wound (8.0 cm x 5.1 cm x 0.3 cm), wound bed now black, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed now gray, and (0.5 cm x 2.0 cm x 0.1 cm), wound bed gray, both had drainage, patient rated pain at “8”, and stated “... Called wound clinic and patient was given an appointment for 11/11 [2021] as wounds need attention and orders ... Patient is peeling the skin ... precautioned on scratching with hangers and other objects as she has done in the past ... wounds 1 and 2 have increased and wound bed does not present with any viable [living] tissue ... Wound burned and hurt while cleansing ... No wound care orders ... covered with gauze and taped in place ... Patient stated she is ready to just have her leg cut off ... complained about being weak and tiring out very quickly ....”. The document evidenced the agency RN supervisor was informed, but the record failed to evidence an RN re-assessment was completed. A document dated and signed by alternate clinical manager A on 11/11/2021at 8:44 PM titled “Physician Supplemental Order” evidenced wound treatments orders which stated “... Order Received: 11/12/2021 ... lower left leg venous stasis ulcers ... Cleanse with normal saline, apply betadine to wound, apply silver alginate [aquacel Ag+], dry gauze dressing and compression dressing (Tubi grip) three times weekly or PRN [as needed] if dressing becomes soiled or dislodged ....” The record failed to evidence a wound clinic M note dated 11/11/2021. A document dated and signed by LPN E on 11/12/2021 titled “... SN Visit Note” evidenced (L) lower leg wound (8.0 cm x 5.1 cm x 0.3 cm), wound bed black, gray, brown, and tan, debrided by wound clinic M on 11/11/2021, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed gray, and (0.2 cm x 0.9 cm x 0.1 cm), wound bed pink, both had drainage, and patient rated pain at “8”. A document dated and signed by LPN E on 11/15/2021 titled “... SN Visit Note” evidenced (L) lower leg wound (7.6 cm x 5.1 cm x 0.3 cm), wound bed black, gray, brown, and tan, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed gray, and (0.5 cm x 0.2 cm x 0.1 cm), wound bed white, both had drainage, patient rated pain at “8”, wounds were painful to touch, patient squirmed during care, which made wound care difficult to perform, and ALF staff reported patient was consuming alcoholic beverages. The document failed to evidence the nurse assessed when last pain medication given or if patient was due for pain medication. A document dated and signed by LPN E on 11/20/2021 titled “... SN Visit Note” evidenced (L) lower leg wound (10.5 cm x 8.5 cm x 0.3 cm), wound bed black, gray, brown, and tan, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm) – morphed into wound #1 (above), (0.0 cm x 0.0 cm x 0.0 cm), wound healed, new wound on left shin, (0.2 cm x 0.2 cm x <0.1 cm), with large amount of clear serous drainage, dressings were saturated, patient rated pain at “7”, wounds were painful to touch, agency RN supervisor was notified, and the record failed to evidence an RN re-assessment was completed. A home visit was observed on 11/22/2021 at 10:30 AM with LPN E. The patient presented sitting on her couch, with her left leg elevated on her walker seat, the old dressing was visibly saturated with yellow-colored fluid. Upon removal of old dressing, the (L) lower leg was visibly larger in diameter than the (R) lower leg, “way worse” per LPN E, was firm, red, edema present from knee distal through toes, copious clear yellow fluid draining from lateral shin, and LPN E indicated the patient had an appointment with an infectious disease physician later today (11/22/2021). During wound care, the patient complained of severe pain, indicated her leg was hot, burning, very painful, made the nurse stop wound care several times to take a break, and asked for pain medication, to which LPN E indicated she didn’t know if it was time for her pain medication(s). The patient moaned in pain, and yelled out several times during wound care. During this time, an open area was observed by the surveyor on left inner/front ankle, approximately the size of a dime, with a yellow wound bed, several other small open and/or scabbed areas, and generalized dry, scaly skin on the lower extremity. Upon completion of the wound care at 11:35 AM, ALF L staff nurse O administered pain medication(s). After the visit was completed, LPN E, the surveyor, and ALF staff nursing manager N met to discuss the patient. When asked if the patient would benefit from pre-medicating for pain prior to wound care, LPN E indicated it would be hard to pre-medicate because she never knew when she was going to get there to do the wound care, and ALF staff nursing manager N indicated pre-medicating for pain would benefit the patient. A document dated and signed by LPN E on 11/22/2021 titled “... SN Visit Note” stated “... Wound care completed as ordered. Patient tolerated fairly well. Patient had pain medication 2 hours prior to my visit and was not allowed any more at this time ... MD is to come to the facility one day this week and address the pain ....” The document evidenced the agency RN supervisor was notified, and the record failed to evidence an RN re-assessment was completed. A document dated and signed by LPN E on 11/26/2021 titled “Missed Visit Note” indicated the patient taken was taken by ambulance to the hospital just prior to her arrival for a nursing visit for unknown diagnosis at this time. Hospital D documents (not part of patient’s agency record) received and reviewed on 12/06/2021 evidenced a document dated 11/26/2021 titled “Emergency Documentation” evidenced the patient complained of pain and swelling to left lower extremity since Wednesday (11/24/2021), but was admitted with pneumonia, and discharged on 12/01/2021. During an interview on 12/07/2021 at 10:50 AM, when asked who was responsible for the patient’s wound care/management, alternate clinical manager A indicated the patient went to the wound clinic every week, asked the surveyor if the wound was their (agency) responsibility, indicated they (agency) followed wound care orders, and asked again if they (agency) was supposed to be responsible. When asked if a wound could deteriorate in less than a week, clinical manager B stated “Yes, a wound can deteriorate in less than a week.” Alternate clinical manager A then indicated LPN E sent the patient to the hospital for the worsening wound, and indicated the agency couldn’t control everything or they’d be God, they saw the patient twice weekly, and if it worsened, we sent her to the hospital, and also indicated the patient was an alcoholic. During this time, agency corporate person A asked if the patient was malnourished, alternate clinical manager A stated “... probably ... there’s a lot of issues with her ... she sticks stuff down in her dressing and scratches her legs ....” When asked if her actions caused more wounds, alternate clinical manager A stated “... Sometimes ya [sic] ... they got worse or got infected ....” When asked if the physician or wound clinic M was made aware of the alcoholism or the patient sticking coat hangers in her dressings and causing new or worsening wounds, alternate clinical manager A stated, “I don’t know.” During this time, clinical manager B stated, “I just want to make sure it’s reflected that ... [patients #6 and 7 ] ... both go to wound clinic weekly ....” 10. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, certification period 12/07/2021 – 02/04/2021, primary diagnosis unstageable pressure ulcer, sacral (lower back) region, other pertinent diagnoses unstageable pressure ulcer (L) buttock, cellulitis left lower extremity (LLE), unspecified dementia, and dependence on wheelchair, evidenced a document dated and signed by RN G on 12/07/2021 titled “... Start of Care ....” evidenced the patient had no pain, an unstageable pressure ulcer on the coccyx (tailbone area) which measured 6.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage (a white, yellow, or brown fluid, might be slightly thick in texture, a sign of infection), gray wound bed, with macerated skin around the wound (maceration occurs when skin has been exposed to moisture for too long. A telltale sign of maceration is skin that looks soggy, feels soft, or appears whiter than usual. There may be a white ring around the wound in wounds that are too moist or have exposure to too much drainage); and an unstageable pressure ulcer on the (L) buttock, which measured 5.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage, gray wound bed, and surrounding skin was erythemic (redness of the skin caused by congestion of the capillaries in the lower layers of the skin; occurs with any skin injury, infection, or inflammation). The document also evidenced calmoseptine was applied to both wounds, the nurse was going to see the patient twice weekly, and FNP C was scheduled to see the patient 12/08/2021 for wound care orders. The section of the document titled “Additional Description/Comments for Integumentary [skin] Assessment” was blank, and failed to evidence the nurse assessed the patient’s LLE was assessed for the known diagnosis of cellulitis. A document dated and signed by alternate clinical manager A on 11/09/2021 titled “... SN Visit Note” evidenced the patient had a pain level “4”, bilateral lower extremity (BLE) non-pitting edema (when skin is pressed with your finger and it doesn't leave an indentation in the skin), FNP ordered antibiotics and referral to wound clinic, and failed to evidence what the antibiotics were ordered for, or the nurse assessed the skin color, temperature, characteristic, or presence of pulses. A document dated and signed by RN G on 11/13/2021 titled “... SN Visit Note” evidenced the unstageable pressure ulcer on the coccyx (tailbone area) measured 5.6 cm x 3.8 cm x 1.0 cm, with thin, watery pale pink to red drainage, gray wound bed; and the unstageable pressure ulcer on the (L) buttock, which measured 4.8 cm x 4.0 cm x 1.0 cm, with thin, watery pale pink to red drainage, gray wound bed, and surrounding skin was intact, pain level was “3”, and stated “Pressure ulcer to coccyx and ischium [left buttock] improved this visit ... [patient] ... does state ‘ouch’ during cleansing of wound ....” The document failed to evidence the nurse assessed the patient’s BLE for known cellulitis. A home visit was observed on 12/15/2021 at 10:06 AM, with alternate clinical manager, RN G and surveyor P also present. Observed a sheet of paper attached on the refrigerator which stated “... compression sock [socks that apply gentle pressure to your legs and ankles, promoting blood flow from your legs to your heart, and help control swelling] on (L) [left leg] ....”, observed patient lying on her left side in bed, with lower-calf length loose-fitting socks on both feet, both feet/lower legs slightly swollen, particularly along and above sock line, RN G removed socks, and LLE was red, dry, and scaly, with skin flaking off. RN G then removed the patient’s incontinence brief tab over the right hip, and exposed wounds which were not covered with dressings. During this time, RN G indicated ALF K knew she was coming, performed incontinence care and removed the dressings prior to our arrival. Six wounds were initially observed; there was a large unstageable pressure ulcer observed on the coccyx, greater in size than the diameter of a baseball (baseball = 7.3-7.5 cm), at least 1.0 cm deep, gray/black wound bed, and small amount of tan slough. Drainage could not be determined due to removal of old dressing; a full-thickness wound (damage extended below all layers of the skin) which bordered the lower part of the coccyx ulcer, located at approximately 7:00 o’clock, with a beefy red wound bed, extending diagonally down, approximately 5.0 -7.0 cm x 2.0 – 3.0 cm x 0.1 - 0.2 cm, unknown drainage; a wound on the (R) ischium, with undermining at the 12:00 o’clock position; the tissue, when lifted, was yellow slough, and the remaining wound bed was gray/black, size was approximately 3.0 – 4.0 cm in diameter, larger when undermining exposed, and depth at least 1.0 cm, unknown drainage; a full-thickness wound to the upper left of the (R) ischium wound, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep; a full-thickness wound to the lower left of the (L) ischium wound, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep, drainage unknown; a full-thickness wound below the (R) ischial wound on the upper/back thigh, just below the posterior buttock crease, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep, drainage unknown. The patient’s skin surrounding all wounds/buttocks area was erythemic. During wound care, the RN G applied foam dressings with adhesive borders directly stuck on open wound beds, and indicated to alternate manager A that she would talk to FNP C about a bigger dressing. During wound care, the patient yelled out in pain, flinched, grabbed at wounds, and yelled for the nurse to stop. After this wound care was completed, Surveyor P asked RN G to assess the patient’s back prior to turning her over. The patient’s back was exposed, and an unstageable wound was observed on the patient’s right lateral (side) trunk, mid- thoracic level (from shoulder level and downward to upper level of lower back), approximately 1.0 – 2.0 cm x 3.0 4.0 cm x 0.0 cm, black eschar, surrounding skin erythemic; and a long dark red/purple line approximately 5-6 inches in length along the right-side waistline/crease with no open area. During this time, alternate clinical manager A indicated the patient always leaned to that side (right) when she was seated up in a chair. Both areas were left open to air (OTA). RN G and alternate clinical manager A turned patient over onto her right hip, and an additional wound was observed, which was approximately 5.0 cm x 10.0 cm x 0.0 cm, raised and swollen, boggy upon touch by RN G, dark purple with erythemic skin around wound, and an open area on the distal portion of this wound which was approximately 1.0 – 2.0 in diameter, approximately 0.1 -0.2 cm deep, with a red wound bed and white pinpoint size areas. During this visit, RN G did not measure any wounds with an actual measuring device. When asked, RN G indicated she had a ruler in her car; when asked how she determined wound depth, she indicated the wounds had no depth. When the patient was positioned onto her right side after all care was completed, she yelled out in pain as her leg was lifted to prop a blanket between her knees. A total of 9 wounds were identified during this home visit. During an interview on 12/15/2021 at 11:00 (immediately after the home visit at ALF K), when asked if ALF K staff assessed patient wounds at this facility, alternate clinical manager indicated she did not know. During this time, RN G indicated she just talked to ALF K staff to request a hospital bed and a special mattress. When asked if the agency provided social work services, alternate clinical manager A indicated the agency did, but this facility had their own. A document dated and signed by RN G on 11/15/2021 titled “... SN Visit Note” evidenced the nurse documented only 6 wounds, identified the ischial (buttock) wound as located on the left side, when it was actually on the right ischium, documented the coccyx wound as 1.0 cm in depth, left buttock as 1.0 cm in depth, and all other wounds as < 0.1 cm in depth; documented the patient’s pain was a “4”, aching, and the patient had no pain medications ordered; and documented the patient had no new pressure ulcers identified this visit. An undated document received from ALF K on 12/17/2021 titled “Medication Record” evidenced norco (narcotic pain medication) was ordered on 12/08/2021 to be given every 8 hours as needed for moderate to severe pain, and tylenol was ordered 12/08/2021to be given every 6 hours as needed for mild pain. During an interview on 12/13/2021 at10:45 AM, when asked how the wound re-assessments went as part of the IJ removal plan, clinical manager A indicated if the wounds were stalling or getting worse, they called the physician or wound clinic. When asked if any patients re-assessed had stalled or worsening wounds, alternate clinical manager A indicated a patient was recently admitted (patient #11), the wound worsened after admission to home care services, and the original wound treatment order was just putting calmoseptine on there for 2 large wounds. During this time, the complete clinical record was requested for review. During an interview on 12/13/2021 at 11:15 AM, when asked what would cause maceration on the skin surrounding the wound(s), alternate clinical manager A indicated the patient was incontinent, and sat in her recliner/ or wheelchair all the time, RN G admitted the patient on 12/07/2021, and because of the decline in 2 days, we increased the frequency and changed wound treatment. When asked if calmoseptine was an appropriate wound treatment as ordered upon admission, alternate clinical manager A stated “... No, which is why we called to get another order ... Yes, this wound got worse from the 7th to the 9th ....” 11. During an interview on 11/19/2021 at 1:00 PM, when asked to describe the agency’s process for when an LPN found a new or worsening change in patient condition, alternate clinical manager A indicated she would inform the RN case manager, other team members, the physician, and write an order if needed. When asked if an RN should then go out and re-assess the patient after a reported new or worsening change, alternate clinical manager A indicated she didn’t think it was mandated that an RN had to go out and assess the patient. 12. During an interview on 11/30/2021 at 12:30 PM, when asked who assured the patients’ needs were continually assessed, clinical manager B indicated it was alternate clinical manager A’s responsibility, in conjunction with the RN case managers. 13. During an interview on 12/06/2021 at 1:13 PM, when asked if an RN should perform a comprehensive assessment prior to continuation of a patient who received therapy services only, if a COTA (certified occupational therapy assistant) documented a missed visit due to the patient being hospitalized the previous day after going unresponsive at an outing, alternate clinical manager A indicated an RN visit wasn’t required for the patient after he/she was found unresponsive. 14. During an interview on 12/14/2021 at 11:14 AM, clinical manager B indicated the agency did have a lot of patients, their growth occurred within the last 60 days, (agency) would stop taking patients until they got this pulled together, she knew that you (surveyor) reviewed charts with patients that were hospitalized, but no one can be sure that it was our fault; she knew re-hospitalization rate in Indiana was 15% and (agency’s) is 19%, and when asked when the re-hospitalization data was obtained, clinical manager A stated “... like within the last 6 months, I think ... we cannot be there 24/7 ....”

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the physical therapist (PT) failed to ensure the comprehensive assessment was completed within 5 calendar days after the start of care for 1 of 2 records reviewed when therapy was the only service(s) provided (#3). Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment for each patient ... documented in the patient’s clinical record ... will be completed within five (5) calendar days of the patient’s start of care ....” Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, evidenced a document dated 08/20/2021, titled “... PT Start of Care ....”, was authenticated/electronically signed by PT J on 08/30/2021, 10 days after the start of care. During an interview on 11/17/2021 at 10:42 AM, when queried the timeframe allowed for clinicians to submit documentation following a visit, administrator/RN (registered nurse) A indicated she preferred 48 hours for start of care/admissions, and 24-48 hours for regular visits. When queried the timeframe for documents to be incorporated in the patient’s record, she indicated the record was electronic, so it was immediate.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the registered nurse (RN) and/or physical therapist (PT) failed to ensure the patient’s comprehensive assessment included the patient’s current health, psychosocial, and/or cognitive status for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment for each patient ... documented in the patient’s clinical record ... including at least the following ... physical assessment ... skin ... height/weight ... other relevant data related to pertinent physical findings ... functional status ... medical and psychosocial history ... psychosocial status ... Name of the hospital, other agencies, and persons involved in the past and present care of the patient ... assessment of emergency preparedness of the patient ... Immunizations ....” 2. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer of left buttock, and other pertinent diagnosis stage 2 pressure ulcer of right buttock, evidenced a document dated and signed by RN G on 10/29/2021 titled “... Recertification [comprehensive assessment] ....” This document evidenced the patient had an open area to left ankle, believed to be a pressure area, she was disoriented, dependent for care, chairbound, resided in an assisted living facility (ALF), The document failed to evidence the nurse assessed the open area on the left ankle, dates of pneumonia or tetanus vaccines, COVID-19 immunization status, the patient’s ability to comprehend teaching, or which ALF the patient resided at. During an interview on 11/30/2021 at 1:30 PM, when queried if the RN screened for COVID-19 immunizations as part of the comprehensive assessment, clinical manager B stated “... Yes ... It’s under immunizations ....”, and indicated the nurse didn’t do it on 10/29/2021. When queried if she would expect the left ankle to be assessed, clinical manager B stated “... No, because she did a skin assessment ....” When queried if it was documented in the comprehensive assessment, she did not respond. 3. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, evidenced a document titled “Home Health Certification and Plan of Care” for certification period 9/24/2021 – 11/22/2021, evidenced a primary diagnosis dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs), and other pertinent diagnoses included insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) (9/21/2021), encounter for attention to gastrostomy (g tube), atherosclerotic heart disease (hardening of the arteries), hypertensive chronic kidney disease (high blood pressure caused by the narrowing of your arteries that carry blood to your kidneys), end stage renal disease (kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life), dependence on dialysis, and history of old myocardial infarction (heart attack) and coronary angioplasty (a medical procedure in which a balloon is used to open a blockage in an artery in the heart); and a document titled “Home Health Certification and Plan of Care” for certification period 11/23/2021 – 1/21/2021, which evidenced a primary diagnosis of pressure ulcer of sacral (lower back) region on 11/02/2021, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) (11/02/2021), dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) (11/02/2021), and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) (10/12/2021). A document dated and signed by RN I on 09/24/2021 titled “... Start of Care [comprehensive assessment] ....” evidenced the patient went to dialysis on Mondays, Wednesdays, and Fridays, she had a fistula (venous access for dialysis) in her right upper arm, and failed to evidence which ALF the patient resided, COVID-19 vaccination status, dates of flu/pneumonia vaccines, where she attended dialysis, or the patient’s ability to comprehend teaching. A document dated and signed by RN I on 11/18/2021 titled “... Recertification ....” evidenced the patient had current flu/pneumonia vaccines, “stated” weight was 125 pounds, and nutritional status was “probably inadequate”. The document failed to evidence the nurse assessed the patient’s weight, dates flu/pneumonia vaccines administered, or COVID-19 vaccination status. A home visit was observed on 11/18/2021 at 12:55 PM, with RN I and the patient’s daughter present. During the visit, RN I failed to assess the patient’s right arm fistula, assess the patient’s current weight, or obtain vaccination dates and/or statuses. 4. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis Alzheimer’s disease, unspecified, secondary diagnoses dementia, repeated falls, essential (primary) hypertension (high blood pressure), type 2 (adult onset) diabetes, major depressive disorder, anxiety disorder (unspecified), long term (current) use of aspirin, and history of falling, evidenced a document dated 08/20/2021 and signed by PT J on 08/30/2021 titled “... PT Start of Care ....” This document evidenced the patient resided at ALF Q, flu/pneumonia vaccines were current, the patient had impaired judgement/poor safety awareness, and failed to evidence the PT assessed height/weight, dates flu/pneumonia vaccines were administered, or COVID-19 vaccination status. 5. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis Alzheimer’s disease (unspecified), secondary diagnoses included dementia, repeated falls, major depressive disorder, anxiety disorder (unspecified), essential (primary) hypertension (high blood pressure), hyperlipidemia (high cholesterol (unspecified), hypothyroidism (unspecified), and history of falling, evidenced a document dated 10/29/2021 and signed by PT J on 11/02/2021 titled “... PT Start of Care ....” This document evidenced the patient had a history of falls, lived in an ALF, flu/pneumonia vaccines were current, incontinent of urine, forgetful, disoriented, and failed to evidence which ALF the patient resided at, the PT assessed the patient’s height or weight, assessed the patient’s risk for skin breakdown, dates flu/pneumonia vaccines were administered, or COVID-19 vaccination status. 6. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, primary diagnosis type 2 (adult onset) diabetes with foot ulcer (open wound), evidenced a document dated and signed by administrator/RN A on 09/08/2021 titled “... Start of Care ....” The document evidenced the patient lived in an ALF, blood sugar was checked before meals and at bedtime, had a right above knee amputation, had blood work done twice yearly for HgbA1c (a blood test to determine average blood sugar levels over the past 2-3 months), indwelling urinary catheter, treated for urinary tract infection (UTI) within the past 14 days, had a wound clinic appointment on “Thursday” (unknown date), and change urinary catheter every month and as needed. The document failed to evidence the RN assessed the patient’s height or weight, dates flu/pneumonia vaccines were administered, COVID-19 vaccination status, most recent blood sugar level, most recent HgbA1c level, assessment of urine (for signs/symptoms of UTI), when the urinary catheter was last changed/due to be changed next, what ALF the patient resided at, or which wound clinic the patient was seen at. During an interview on 11/30/2021 at 3:00 PM, when queried, clinical manager B indicated the patient’s urine should be assessed every visit. During an interview on 12/01/2021 at 2:45 PM, when queried, person W (director of nursing at ALF V) indicated their staff administered the patient’s medications, the patient was diabetic, and the home health agency did wound care and managed the urinary catheter. During this time, person X (ALF V staff RN) indicated (we) usually draw the labs, the patient had a weekly lab draw on Tuesdays for therapeutic drug monitoring for Procrit (a medication used for the treatment of anemia in patients with chronic kidney disease who are not on dialysis to raise or maintain the red blood cell level and to reduce the need for blood transfusions), it was administered if the patient’s hemoglobin (A protein inside red blood cells) was less than 10, the patient was a brittle (very unstable) diabetic, he had a lot of recurrent UTIs, ALF V staff couldn’t manage indwelling urinary catheters, the home health agency did the urine lab tests, agency doesn’t send reports to us, and (we) really don’t have anything to do with home health care. 7. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), and personal history of COVID-19 (04/27/2021), evidenced a document dated and signed on 10/22/2021 by RN I titled “... Recertification ....” This document evidenced flu vaccination status was current (last administered 09/07/2020), pneumonia vaccination status was current (unknown date), the patient had 4 or more stasis ulcers (wounds caused by impaired circulation), next wound care appointment was 10/25/2021, the patient was diagnosed with congestive heart failure (CHF) and had lower extremity swelling, resided at ALF L, and previously lived at home, had a fall, and sustained a brain injury. The document failed to evidence the date the pneumonia vaccine was administered, COVID-19 vaccination status, who performed wound care when no agency staff present; and failed to evidence which wound clinic the patient was seen at. During an interview on 12/07/2021 at 10:50 AM, when queried who was responsible to manage wounds, administrator A indicated (patients #6 and 7) went to the wound clinic weekly, and questioned if it was her responsibility. 8. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), secondary diagnoses included hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), congestive heart failure, non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow), personal history of COVID-19 (07/02/2021), and personal history of pneumonia (07/02/2021), evidenced a document dated and signed on 10/26/2021 by RN G titled “... Recertification ....” This document evidenced the patient was vaccinated for flu and pneumonia on 10/05/2021, but stated “... can’t recall date ....”, was vaccinated for COVID-19 on 10/05/2021, dietary intake was probably inadequate, was a nutritional risk, ALF L staff was not permitted to perform wound care, the wounds were slow healing, the patient went to the wound center weekly, and had a pacemaker. The document failed to evidence the RN assessed the patient’s current weight, which COVID-19 vaccine was administered, or if a second vaccine was due/overdo, and failed to evidence the patient’s psychosocial status, who performed wound care when no agency staff present, or when the type of pacemaker, when it was inserted, the last time it was checked, when it was next due to be checked, or what physician managed it. During an interview on 12/07/2021 at 10:50 AM, administrator A indicated ALF L staff did wound care on an as needed (PRN) basis. When queried what would prompt them to perform wound care, administrator a stated “... If it [dressing] becomes dislodged or soiled ... she’s also an alcoholic ....” During this time, corporate regulatory and resource specialist A queried if the patient was malnourished, administrator A stated “... probably ... there’s a lot of issues with her ... she sticks stuff down in her dressing and scratches her legs ....” A home visit was observed on 11/22/2021 at 10:30 AM with licensed practical nurse (LPN) E present. The patient indicated she had the pacemaker inserted about 3 years ago. Upon exiting the patient’s room, LPN E indicated the patient and family were non-compliant, they brought alcohol in for her, and she used a coat hanger to dig at her legs. 9. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis unspecified open wound, right lower leg, subsequent encounter, secondary diagnoses unspecified open wound, left lower leg, subsequent encounter, unspecified juvenile rheumatoid arthritis, essential (primary) hypertension (high blood pressure), adjustment disorder with depressed mood, hypothyroidism (unspecified), unspecified urinary incontinence, and history of falling, evidenced a document dated and signed on 06/09/2021 by administrator/RN A titled “... Recertification ....” This document evidenced the patient was current on flu/pneumonia vaccinations, was chairfast (ability to walk severely limited or non-existent, cannot bear own weight and/or must be assisted into chair), he was oriented, continued to have multiple falls, needed skilled nursing for wound care, and lived at ALF Y, and failed to evidence the RN assessed the patient’s weight, failed to evidence the date the flu/pneumonia vaccines were administered, COVID-19 vaccination status, or who provided wound care when no agency staff were present. 10. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood), permanent atrial fibrillation (irregular heart rhythm), dilated cardiomyopathy (weak heart muscle which causes inability to pump blood efficiently throughout the body), heart failure, end stage renal (kidney) disease, dependence on renal dialysis, diabetes, major depressive disorder, and long term use of anticoagulants (blood thinners), evidenced a document dated and signed on 04/30/2021 by administrator/RN A titled “... Start of Care ....” This document evidenced the patient was not having symptoms of respiratory infection during the comprehensive assessment, current on flu/pneumonia vaccinations, had a right arm fistula and right permacath (venous accesses for dialysis treatment), dialysis was not given while in the hospital, and 3 “as needed” nursing visits to obtain blood specimen for anticoagulant therapeutic lab monitoring, and failed to evidence the RN assessed the patient’s weight, the date the flu/pneumonia vaccines were administered, COVID-19 vaccination status, assessment of the right arm fistula and right permacath, when the last lab draw was done/when next due, if dialysis was resumed, where the patient attended dialysis, or the dialysis frequency/schedule. 11. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, bed confinement status, evidenced a document dated and signed by RN I on 11/07/2021 titled “... Start of Care ....” This document evidenced the patient went to dialysis on Tuesdays, Thursdays and Saturdays, flu/pneumonia vaccinations were current, had a left upper arm single lumen PICC (peripherally inserted central catheter line- a tube inserted in a smaller vein in the arm, extending up to a larger vein, to administer intravenous treatments), nurse was to obtain weekly lab draws, and the patient needed assistance for all activities. The document failed to evidence the date the flu/pneumonia vaccines were administered, COVID-19 vaccination status, location of the venous access site for dialysis, when the last lab draw was done/when next due, or where the patient attended dialysis. 12. Record review for patient #11 was completed on 12/15/2021, start of care 12/07/2021, certification dates 12/07/2021 – 02/04/2022, primary diagnosis pressure ulcer of sacral (lower back) region, unstageable, other diagnoses pressure ulcer of left buttock, unstageable, cellulitis of lower limb, and unspecified dementia without behavioral disturbance, evidenced a document dated and signed on 12/07/2021 by RN G. This document evidenced the patient resided at ALF K, swelling of the legs, she was oriented but forgetful, confused in new or complex situations only, but then indicated patient failed to recognize familiar persons/places, inability to recall events of last 24 hours, significant memory loss so that supervision was required, had open, draining wounds, was totally dependent for all care, and was chairfast. The document failed to evidence the patient’s learning barrier of severe hearing impairment, and confusion, the patient wore a hearing aid, she had extensive tooth decay/very poor oral hygiene, skin status/assessment findings for lower extremity cellulitis, pedal (pulses on the tops of the feet) pulses, who performed wound care when no agency staff present, or the primary caregiver’(s) extent or availability of care provided. 13. During an interview on 11/18/2021 at 11:00 AM, administrator A indicated psychosocial and cognitive statuses were not included unless they were addressing it, or if there was an issue. 14. During an interview on 12/13/2021 at 2:36 PM, when queried why nearly all comprehensive assessments indicated immunizations were current, but there were no dates of administration, and stated “can’t recall date”, clinical manager B stated “... Maybe they just don’t know ....” 15. During an interview on 12/14/2021 at 12:22 PM, clinical manager B indicated she wanted to investigate adding some new prompts in the EMR (electronic medical record) to address patients’ psychosocial and cognitive statuses. 17-14-1(a)(1)(A) 17-14-1(a)(1)(B)

Strengths, goals, and care preferences CFR(s): 484.55(c)(2) The patient's strengths, goals, and care preferences, including information that may be used to demonstrate the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse and/or physical therapist failed to ensure the patient’s comprehensive assessment included the patient and/or caregiver’s personal goals, care preferences, and/or included information to demonstrate the patient's progress toward goals for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment for each patient ... documented in the patient’s clinical record ... including at least the following ... Patient problems/needs/strengths ... information to be used to measure the patient’s progress toward achievement of desired outcomes ....” 2. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer of left buttock, and other pertinent diagnosis stage 2 pressure ulcer of right buttock, evidenced a document dated and signed by RN G on 10/29/2021 titled “... Recertification [comprehensive assessment] ....” This document evidenced the patient was disoriented, dependent for care, chairbound, required wound care twice weekly, and a section titled “60 Day Summary [summary of care over the past 60 days] ....”, which failed to evidence any information of the patient’s response/progress to wound care provided, progress of the wounds, any resolved problems, or patient/caregiver response to any teaching provided from the previous 60 days of service. Additionally, the document failed to evidence the nurse assessed the patient/caregiver for personal goals or care preferences. 3. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, primary diagnosis dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses included insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) on 9/21/2021, encounter for attention to gastrostomy (g tube); and certification period 11/23/2021 – 1/21/2021, primary diagnosis pressure ulcer of sacral (lower back) region on 11/02/2021, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) on 11/02/2021, dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) on 11/02/2021, and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) on 10/12/2021. A document dated and signed by RN I on 09/24/2021 titled “... Start of Care [comprehensive assessment] ....” evidenced the patient was oriented (able to comprehend and make decisions), and a section titled “Individual Goals for [patient] ....” evidenced agency goals for patient and/or caregiver included: will identify measures to prevent skin breakdown and remain free of skin breakdown, effective in tube feeding management, and verbalize understanding of signs/symptoms of aspiration and how to prevent. The document failed to evidence the nurse assessed the patient/caregiver for personal goals or care preferences. A document dated and signed by RN I on 11/18/2021 titled “... Recertification ....” evidenced the patient developed skin breakdown, and still had difficulty swallowing; and failed to evidence any resolved problems, or progress towards goals, which included if the patient/caregiver could identify measures to mitigate new and prevent further skin breakdown, if the patient and caregiver were effective in tube feeding management, or verbalized understanding of signs/symptoms of aspiration and how to prevent it since goals developed at start of care. The document also failed to evidence the nurse assessed the patient/caregiver for personal goals or care preferences. A home visit was observed on 11/18/2021 at 12:55 PM, with RN I and the patient’s daughter present. During this time, the daughter indicated she was very overwhelmed with taking care of her mother, and would like more help. 4. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis Alzheimer’s disease, unspecified, secondary diagnoses dementia, repeated falls, which evidenced a document dated 08/20/2021 and signed by PT J on 08/30/2021 titled “... PT Start of Care ....” This document evidenced the patient resided at ALF Q, and failed to evidence who the primary caregiver was, or patient personal goals or care preferences was assessed. 5. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis Alzheimer’s disease (unspecified), secondary diagnoses included dementia, repeated falls, major depressive disorder, anxiety disorder (unspecified), essential (primary) hypertension (high blood pressure), hyperlipidemia (high cholesterol (unspecified), hypothyroidism (unspecified), and history of falling, evidenced a document dated 10/29/2021 and signed by PT J on 11/02/2021 titled “... PT Start of Care ....” This document failed to evidence who the primary caregiver was, or patient personal goals or care preferences was assessed. A home visit was observed on 11/18/2021 at 9:45 AM at ALF Q, with PT M present. PT M indicated the patient probably needed help with meals, she would let the ALF staff know, the patient was unable to follow a home exercise program (HEP), and the patient’s sister was her primary caregiver, who was not present during the visit. 6. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, primary diagnosis type 2 (adult onset) diabetes with foot ulcer (open wound), evidenced a document dated and signed by administrator/RN A on 09/08/2021 titled “... Start of Care ....” This document failed to evidence who the primary caregiver was, or patient personal goals or care preferences was assessed. 7. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), and personal history of COVID-19 (04/27/2021), evidenced a document dated and signed on 10/22/2021 by RN I titled “... Recertification ....” This document evidenced the patient received nursing services for wound care, and had 4 or more stasis ulcers (wounds caused by impaired circulation), the treatment approach had not been modified, and agency goals included for the patient to maintain or develop clean and intact skin, and reduction and prevention of excess fluid volume. The document failed to evidence the progress of the wound healing status, patient response to treatment, fluid volume status progression, or patient personal goals or care preferences was assessed. 8. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), secondary diagnoses included hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), congestive heart failure, non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow), personal history of COVID-19 (07/02/2021), and personal history of pneumonia (07/02/2021), evidenced a document dated and signed on 10/26/2021 by RN G titled “... Recertification ....” This document evidenced the patient received skilled nursing services for wound care, failed to evidence any resolved problems over the past certification period, progress of wound healing, progress towards goals, or patient personal goals or care preferences was assessed. 9. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis unspecified open wound, right lower leg, subsequent encounter, secondary diagnoses unspecified open wound, left lower leg, and history of falling, evidenced a document dated and signed on 06/09/2021 by administrator/RN A titled “... Recertification ....” This document evidenced the patient received skilled nursing services for wound care, but failed to evidence any resolved problems over the past certification period, progress of wound healing, progress towards goals, or patient personal goals or care preferences was assessed. 10. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood), evidenced a document dated and signed on 04/30/2021 by administrator/RN A titled “... Start of Care ....” This document evidenced the patient had a primary caregiver, and failed to evidence patient/caregiver’s personal goals or care preferences was assessed. During an interview on 12/02/2021 at 1:56 PM, family indicated he would have liked to have a nurse come more than 1 time per week, but he just “went with what they said”. 11. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, bed confinement status, evidenced a document dated and signed by RN I on 11/07/2021 titled “... Start of Care ....” This document evidenced the patient lived with family, daughter was the primary caregiver, the patient had a left upper arm single lumen PICC (peripherally inserted central catheter line- a tube inserted in a smaller vein in the arm, extending up to a larger vein, to administer intravenous treatments), received IV (intravenous) medication and flushes 3 times weekly, needed complex wound care daily, and the patient needed assistance for all activities. The document failed to evidence patient/caregiver’s personal goals or care preferences was assessed. During an interview on 12/02/2021 at 1:16 PM, the patient’s primary caregiver indicated the agency never discussed her care preferences, she would have liked more nursing visits due to the complex care, the agency never offered aide services, and she would have wanted the help for bathing the patient. 12. Record review for patient #11 was completed on 12/15/2021, start of care 12/07/2021, certification dates 12/07/2021 – 02/04/2022, primary diagnosis pressure ulcer of sacral (lower back) region, unstageable, other diagnoses pressure ulcer of left buttock, unstageable, cellulitis of lower limb, and unspecified dementia without behavioral disturbance, evidenced a document dated and signed on 12/07/2021 by RN G. This document evidenced the patient resided at ALF K, had swelling of the legs, she was oriented but forgetful, confused in new or complex situations only, but then indicated patient failed to recognize familiar persons/places, inability to recall events of last 24 hours, significant memory loss so that supervision was required, had open, draining wounds, was totally dependent for all care, was chairfast, the patient’s son was the emergency contact, no primary caregiver was identified, and failed to evidence patient/caregiver’s personal goals or care preferences was assessed. During an interview on 12/13/2021 at 11:15 AM, when queried if the patient could transfer herself, administrator A stated “... No, the assisted living people do it ....” When queried if there was a concern that the patient was too acute (complex needs) for an assisted living facility, administrator A stated “... Ya, possibly ....”, and indicated the patient’s son’s availability, or what he did for the patient was not included on the comprehensive assessment dated 12/07/2021. During an interview on 12/15/2021 at 12:45 PM, when queried who patient #11’s primary caregiver was, administrator A stated “... The assisted living is the primary caregiver ....” 13. During an interview on 11/30/2021 at 12:30 PM, when queried if the comprehensive assessment should include the patient’s strengths, goals, and care preferences, clinical manager B stated “Yes”.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the registered nurse failed to ensure the patient’s comprehensive assessment included patient specific discharge planning needs for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Discharge Planning” stated “... Discharge planning will be initiated for every patient upon admission ... needs will be assessed on an ongoing basis ... During the ... assessment, the clinician will ... Assess the following and identify ... Anticipated date of discharge ... Resources available, including persons and finances ... Anticipated changes in living situation ... Areas that might require assistance ... Consulting with the patient and family/caregiver ....” 2. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer of left buttock, and other pertinent diagnosis stage 2 pressure ulcer of right buttock. Record review evidenced a document dated and signed by RN G on 10/29/2021, titled “... Recertification [comprehensive assessment] ....” This document indicated the patient was disoriented, dependent for care, chairbound, required wound care twice weekly, resided at a memory care assisted living facility (ALF), received skilled nursing for wound care, ALF staff did not perform wound care, and stated “... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” 3. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, evidenced a document titled “Home Care Certification and Plan of Care”. This document evidenced a primary diagnosis of dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses included insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) on 9/21/2021, encounter for attention to gastrostomy (g tube); A document titled “Home Care Certification and Plan of Care” for certification period 11/23/2021 – 1/21/2021, evidenced a primary diagnosis pressure ulcer of sacral (lower back) region, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) on 11/02/2021, dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) on 11/02/2021, and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) on 10/12/2021. A document dated and signed by RN I on 09/24/2021, titled “... Start of Care ....” indicated the patient was oriented (able to comprehend and make decisions), received skilled nursing (SN), physical therapy (PT) and occupational therapy (OT) services, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [PT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [OT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” A document dated and signed by RN I on 10/12/2021, titled “... Resumption of Care [comprehensive assessment] ....” indicated the patient was discharged from the hospital on 10/08/2021, received SN, PT, and OT services, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [PT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [OT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” A document dated and signed by RN I on 11/18/2021, titled “... Recertification ....” indicated the patient developed skin breakdown, and had difficulty swallowing, received SN, PT, OT, and speech language pathologist (SLP) services, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [PT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [OT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” The document failed to evidence SLP discharge plans. A home visit was observed on 11/18/2021 at 12:55 PM, with RN I and the patient’s family member was also present. During this time, the family member indicated they were very overwhelmed with taking care of the patient, and would like more help, and discharge plans were not discussed with the patient or caregiver. 4. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis of Alzheimer’s disease, unspecified, secondary diagnoses dementia, and repeated falls. Record review evidenced a document dated 08/20/2021, and was signed by PT J on 08/30/2021, titled “... PT Start of Care ....” This document indicated the patient received PT, and OT services, and stated “... [PT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [OT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” 5. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis Alzheimer’s disease (unspecified), secondary diagnoses included dementia, repeated falls, major depressive disorder, anxiety disorder (unspecified), essential (primary) hypertension (high blood pressure), hyperlipidemia (high cholesterol (unspecified), hypothyroidism (unspecified), and history of falling. Record review evidenced a document dated 10/29/2021, and was signed by PT J on 11/02/2021, titled “... PT Start of Care ....” This document indicated the patient received PT, and OT services, and stated “... [PT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [OT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” A home visit was observed on 11/18/2021 at 9:45 AM, at ALF Q, with PT M present. PT M indicated the patient probably needed help with meals, the PT would let the ALF staff know, the patient was unable to follow a home exercise program (HEP), and the patient’s family member was the primary caregiver, who was not present during the visit. 6. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, primary diagnosis of type 2 (adult onset) diabetes with foot ulcer (open wound). Record review evidenced a document dated and signed by administrator/RN A on 09/08/2021, titled “... Start of Care ....” This document indicated the patient required SN services for wound and indwelling foley catheter (a tube inserted into the bladder to drain urine) care/management and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” 7. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), and personal history of COVID-19 (04/27/2021). Record review evidenced a document dated and signed on 10/22/2021, by RN I titled “... Recertification ....” This document indicated the patient received SN services for wound care, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” 8. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), secondary diagnoses included hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), congestive heart failure, non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow), personal history of COVID-19 (07/02/2021), and personal history of pneumonia (07/02/2021). Record review evidenced a document dated and signed on 10/26/2021, by RN G titled “... Recertification ....” This document indicated the patient received SN services for wound care and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” During an interview on 11/17/2021 at 10:42 AM, when queried how the agency addressed patient non-compliant issues, administrator A indicated they tried to get family involved, the physician involved, and discharge the patient if last resort. During an interview on 11/22/2021 at 11:14 AM, when queried about the patient’s history, licensed practical nurse (LPN) E indicated the patient was non-compliant, known to consume alcohol regularly, and family brought it to the patient. During an interview on 12/07/2021 at 10:50 AM, when asked if consumption of alcohol could potentially interact with medications, administrator/RN A stated “...Yes ....”, and indicated the patient was an alcoholic, and had a lot of issues. 9. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis of unspecified open wound, right lower leg, subsequent encounter, secondary diagnoses of unspecified open wound, left lower leg, and history of falling. Record review evidenced a document dated and signed on 06/09/2021, by administrator/RN A titled “... Recertification ....” This document indicated the patient received SN services for wound care, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” 10. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, and acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood). Record review evidenced a document dated and signed on 04/30/2021, by administrator/RN A, titled “... Start of Care ....” This document indicated the patient received SN, PT, and OT services, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [PT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ... [OT] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” A document dated and signed on 05/03/2021, by PT AA (contract therapy services BB staff) titled “... Physical Therapy Evaluation ... Initial Evaluation” failed to evidence discharge planning was addressed. A document dated and signed on 05/05/2021, by OT DD (contract therapy services BB staff) titled “... Occupational Therapy Evaluation ... Initial Evaluation” failed to evidence discharge planning was addressed. During an interview on 12/02/2021 at 1:56 PM, when queried why the patient was discharged from the agency, family indicated the patient was very sick, should have never been discharged from the hospital in the first place, and got progressively worse. The family member took the patient back to the hospital because the patient could hardly walk, after a hospital stay, and the patient went to a skilled nursing facility for rehab. 11. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, and bed confinement status. Record review evidenced a document dated and signed by RN I on 11/07/2021, titled “... Start of Care ....” This document indicated the patient lived with family, a family member was the primary caregiver, the patient had a left upper arm single lumen PICC (peripherally inserted central catheter line- a tube inserted in a smaller vein in the arm, extending up to a larger vein, to administer intravenous treatments), received IV (intravenous) medication and flushes 3 times weekly, needed complex wound care daily, the patient needed assistance for all activities, received SN services for this complex care, and stated “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” During an interview on 12/02/2021 at 1:16 PM, when queried if the patient had enough help from the agency, the patient’s primary caregiver indicated they would have liked more nursing visits due to the complex care, the agency never offered aide services, and the family member wanted help for bathing the patient. 12. Record review for patient #11 was completed on 12/15/2021, start of care 12/07/2021, certification dates 12/07/2021 – 02/04/2022, primary diagnosis pressure ulcer of sacral (lower back) region, unstageable, other diagnoses pressure ulcer of left buttock, unstageable, cellulitis of lower limb, and unspecified dementia without behavioral disturbance. Record review evidenced a document dated and signed on 12/07/2021, by RN G. This document indicated the patient resided at ALF K, had swelling of the legs, was oriented but forgetful, confused in new or complex situations only, but then indicated patient failed to recognize familiar persons/places, had inability to recall events of last 24 hours, significant memory loss so that supervision was required, had open, draining wounds, was totally dependent for all care, was chairfast, the patient’s family member was the emergency contact, no primary caregiver was identified, the patient received SN services for wound care, and stated “... “... [SN] ... Discharge Plans: Patient will be discharge [sic] when goals are met, to follow up with physician and assistance from family/ caregiver to manage care ....” During an interview on 12/13/2021 at 11:15 AM, when queried if the patient could transfer herself, administrator A stated “... No, the assisted living people do it ....” When queried if there was a concern that the patient was too acute (complex needs) for an assisted living facility, administrator A stated “... Yeah, possibly ....” 13. During an interview on 11/30/2021 at 12:30 PM, when queried how many days’ notice did the agency give a patient prior to discharge, clinical manager B stated “... cannot recall ... I’ll say 5-7 days ....”, indicated patients received written notice of discharge, and it was in the clinical record. When queried what other documentation and/or orders were required for the discharge process, clinical manager B indicated the discharge OASIS (Outcome and Assessment Information Set) was completed for every patient, a discharge order with reason for discharge, and she thought there was a clinical summary that was within the OASIS. 17-14-1(a)(1)(B)

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the registered nurse (RN) failed to perform a drug regimen review (DRR), and/or identified any major drug reactions for 8 of 10 records reviewed for patients with medications (#1, 2, 3, 4, 5, 6, 7, 11 ). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment for each patient ... documented in the patient’s clinical record ... including at least the following ... current medication use, including prescription, over-the-counter medications and herbal medications, and identifying drug interactions, duplicative drug therapy, and noncompliance with therapy ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Medication Profile” stated “... will have a current, accurate medication profile in the clinical record ... Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications ... A drug regimen review [DRR] will be performed at the time of admission, when updates to the comprehensive assessment are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy ... During subsequent home visits, the medication profile will be used ... to evaluate the use of medications ....” 3. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021. Record review evidenced a document dated and signed by RN G on 10/29/2021, titled “... Recertification [comprehensive assessment] ....” This document indicated the patient’s medication profile included 15 medications, which included diltiazem (prevent irregular heart rhythms), loperamide (anti-diarrheal), and carvedilol/Coreg (reduce blood pressure). The document stated “... I [RN G] attest to all of the following ... I have not identified major potential or actual drug reaction ....” A Drugs.com web-based referenced on 11/29/2021, titled “Drug Interaction Report” indicated 2 major drug interactions between diltiazem and loperamide, and diltiazem and carvedilol; and stated “... This report displays the potential drug interactions for ... 15 drugs ... Major [interaction] ... DilTIAZem may significantly increase the blood levels of loperamide. This can lead to serious and potentially fatal complications such as irregular heart rhythm and cardiac arrest, especially if you use more than the recommended doses of loperamide ... Using dilTIAZem and carvedilol together may lead to increased side effects. This can cause fatigue, headache, fainting, swelling of the extremities, weight gain, shortness of breath, chest pain, increased or decreased heartbeat, or irregular heartbeat ... Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit ....” During an interview on 11/30/2021 at 1:30 PM, when queried to describe the agency’s drug regimen review (DRR), clinical manager B indicated they were performed upon admission, any medication change, and during a recertification visit. When queried who performed DRRs, clinical manager B indicated the clinician (RN) did, the physical therapist (PT) performed the DRR for PT only cases (must be performed by a registered nurse), and it was documented in the comprehensive assessment/OASIS (outcome and assessment information set). When queried under what circumstances would the physician be informed, clinical manager B stated “... If there’s a drug interaction ... allergy ... duplication ....” When queried about the 2 major interactions identified by the surveyor for patient #1, clinical manager B stated “... if they were found, there would have been a fax sent to the MD [physician] ....”, and indicated there was no fax sent to the MD. 4. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, evidenced a document dated and signed by RN I on 09/24/2021, titled “... Start of Care [comprehensive assessment] ....” This document indicated the patient’s medication profile included 14 medications, which included pravastatin (cholesterol lowering), TriCor (cholesterol lowering), Lasix (diuretic), and levoxyl (treat symptoms of an underactive thyroid), all medications were documented on the profile as taken orally, the patient experienced pain, and took analgesics (pain relief). The document stated “... I [RN I] attest to all of the following ... I have not identified major potential or actual drug reaction ... Pt [patient] currently on effective pain med(s) ... Pt is able to take some medications orally; others prescribed via g-tube [tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications] ....” A Drugs.com web-based referenced on 11/29/2021, titled “Drug Interaction Report” indicated 1 major drug interaction between pravastatin and TriCor (fenofibrate), and a drug/food interaction with levoxyl; and stated “... This report displays the potential drug interactions for ... 14 drugs ... Major ... Using fenofibrate together with pravastatin can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death ... The timing of meals relative to your levothyroxine dose can affect absorption of the medication. Therefore, levothyroxine should be taken on a consistent schedule with regard to time of day and relation to meals to avoid large fluctuations in blood levels, which may alter its effects. In addition, absorption of levothyroxine may be decreased by foods such as soybean flour, cotton seed meal, walnuts, dietary fiber, calcium, and calcium fortified juices. These foods should be avoided within several hours of dosing if possible ... Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit ....” During an interview with family on 12/01/2021 at 1:35 PM, when queried if the nurse ever reviewed the patient’s medications with family, family stated “No.” During an interview on 12/7/2021 at 1:54 PM, when queried (with reference to the comprehensive assessment completed on 09/24/2021) if the medication profile listed an analgesic, clinical manager B stated “... No ....”, and also indicated the record did not evidence the major drug interaction. When queried if the medication profile should identify which medications were taken orally, and which were administered via g-tube, clinical manager B stated “... I don’t really want to discuss every item, or we’ll be here forever ....” During an interview at dialysis center F on 12/08/2021 at 10:20 AM, person CC (dialysis center RN) indicated the surgeon who placed the patient’s g-tube on 09/21/2021 discontinued the Lasix at that time, and the patient was not supposed to be on Lasix. During this time, person G (facility administrator), indicated the only communication they had about the patient’s medications was with the patient, not the agency, they would like the agency to provide them with a list of the patient’s medications for comparison, and stated “Yes ... [the patient] was not supposed to be on Lasix ... prior to the placement of the g-tube, [the patient] took 240mg [milligrams] daily ....” During an interview on 12/08/2021 at 11:00 AM, when queried if the patient was supposed to take Lasix, family indicated they didn’t know, and they just had the old bottle (of Lasix) from when the patient used to take 240mg daily. During this time, the family member verbally consented for surveyor to screen shot text messages between herself and RN I. A text message was observed sent from RN I to family on 11/21/2021 at 3:15 PM, which stated, “Do you have any Lasix ....” Family replied “Yes”, RN I replied at 3:17 PM, “... You’ve been instructed that you can give the Lasix if her legs are swollen, right?”, at 3:18 PM (RN I) “... I think we should try Lasix ....”, at 3:35 PM (RN I) “Just give her one Lasix 40mg”. 5. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, and discharge date of 09/24/2021. Record review evidenced a document dated and signed by PT J on 08/20/2021, titled “... PT Start of Care ....” This document indicated the patient’s medication profile included 13 medications, which included amlodipine (reduce blood pressure), simvastatin (cholesterol lowering), ondansetron (to relieve nausea/vomiting), and escitalopram (antidepressant); and stated “... Drug Regimen Review ... Did a complete drug regimen review identify potentially clinically significant medication issues? ... No – No issues found during review ....” The record failed to evidence an RN reviewed the patient’s medication profile or conducted a DRR. A Drugs.com web-based referenced on 11/17/2021, titled “Drug Interaction Report” evidenced 2 major drug interactions between amlodipine and simvastatin, and ondansetron and escitalopram (antidepressant medication); and stated “... This report displays the potential drug interactions for ... 13 drugs ... Major ... Talk to your doctor before using simvastatin together with amLODIPine. Combining these medications may significantly increase the blood levels of simvastatin. This can increase the risk of side effects such as liver damage and a rare but serious condition called rhabdomyolysis that involves the breakdown of skeletal muscle tissue. In some cases, rhabdomyolysis can cause kidney damage and even death ... Using ondansetron together with escitalopram can increase the risk of a rare but serious condition called the serotonin syndrome, which may include symptoms such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea. Severe cases may result in coma and even death ... Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit ....” During an interview on 11/30/2021 at 2:00 PM – 2:21 PM, when queried if a DRR was completed for the comprehensive assessment performed by PT J on 08/20/2021, Clinical manager B indicated she didn’t see that any interactions were sent to the physician. During an interview on 11/30/2021 at 1:30 PM, when queried who performed DRRs, clinical manager B indicated the clinician (RN) did, the physical therapist (PT) performed the DRR for PT only cases (must be performed by a registered nurse), and it was documented in the comprehensive assessment/OASIS (outcome and assessment information set). 6. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, and certification period 10/29/2021 – 12/27/2021. Record review evidenced a document dated and signed by PT J on 10/29/2021, titled “... PT Start of Care ....” This document indicated the patient’s medication profile included 16 medications, which included potassium chloride (electrolyte supplement), irbesartan (to lower blood pressure), losartan (lower blood pressure), oxybutynin (treat symptoms of an overactive bladder), and diphenhydramine/benadryl (allergy/antihistamine); and stated “... Drug Regimen Review ... Did a complete drug regimen review identify potentially clinically significant medication issues? ... No – No issues found during review ....” The record failed to evidence an RN reviewed the patient’s medication profile or conducted a DRR. A Drugs.com web-based referenced on 11/17/2021 at 2:33 PM, titled “Drug Interaction Report” indicated 4 major drug interactions between potassium chloride and irbesartan, potassium chloride and losartan, potassium chloride and diphenhydramine/benadryl, and oxybutynin and potassium chloride; and stated “... This report displays the potential drug interactions for ... 16 drugs ... Major ... Talk to your doctor before using potassium oral tablets or capsules together with diphenhydrAMINE. Depending on the dose of diphenhydrAMINE and your overall physical health, combining these medications may increase the irritant effects of potassium on your stomach and upper intestine. This can rarely result in ulcers, bleeding, and other gastrointestinal injury ... Talk to your doctor before using potassium oral tablets or capsules together with oxybutynin. Depending on the dose of oxybutynin and your overall physical health, combining these medications may increase the irritant effects of potassium on your stomach and upper intestine. This can rarely result in ulcers, bleeding, and other gastrointestinal injury ... Talk to your doctor before using potassium chloride together with losartan. Combining these medications may significantly increase potassium levels in the blood. High levels of potassium can develop into a condition known as hyperkalemia, which in severe cases can lead to kidney failure, muscle paralysis, irregular heart rhythm, and cardiac arrest. You may be more likely to develop hyperkalemia while using these medications if you are elderly, dehydrated, or have kidney disease, diabetes, or advanced heart failure ... Talk to your doctor before using potassium chloride together with irbesartan. Combining these medications may significantly increase potassium levels in the blood. High levels of potassium can develop into a condition known as hyperkalemia, which in severe cases can lead to kidney failure, muscle paralysis, irregular heart rhythm, and cardiac arrest. You may be more likely to develop hyperkalemia while using these medications if you are elderly, dehydrated, or have kidney disease, diabetes, or advanced heart failure ... Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit ....” A document dated and signed by PT M on 11/18/2021, titled “... PT Revisit Note” stated “... [patient] did receive a booster shot yesterday – caregivers think that maybe [sic] why [the patient’s] tired today ... Patient responded poorly to treatment [physical therapy] this visit due to difficulty remaining awake ... they [ALF staff] think it may be due to receiving booster yesterday ....” The document failed to evidence PT M determined what “shot” was administered to the patient, reported to the registered nurse, or a medication reconciliation was performed. During an interview on 11/30/2021 at 2:55 PM, when queried how PT J determined there were no medication issues found during the drug review on 11/18/2021, clinical manager B indicated the PT did not have access to the DRR function (a tab imbedded in the agency’s software program to perform a drug regimen review) in the software, and there was no evidence a DRR was completed. 7. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, and certification period 09/08/2021 – 11/06/2021. Record review evidenced a document dated and signed by administrator/RN A on 09/08/2021, titled “... Start of Care ....” This document indicated the patient’s medication profile included 22 medications, which included diltiazem, carvedilol, and timolol ophthalmic (eye drops to treat glaucoma); and stated “... Drug Regimen Review ... Did a complete drug regimen review identify potentially clinically significant medication issues? ... No – No issues found during review ... I [administrator/RN A] attest to all of the following ... I have not identified major potential or actual drug reaction ....” A Drugs.com web-based referenced on 11/17/2021, at 3:43 PM, titled “Drug Interaction Report” evidenced 2 major drug interactions between diltiazem and carvedilol, and diltiazem and timolol ophthalmic; and stated “... This report displays the potential drug interactions for ... 22 drugs ... Major ... Using dilTIAZem and carvedilol together may lead to increased side effects. This can cause fatigue, headache, fainting, swelling of the extremities, weight gain, shortness of breath, chest pain, increased or decreased heartbeat, or irregular heartbeat ... Using dilTIAZem and timolol ophthalmic together may lead to increased side effects. This can cause fatigue, headache, fainting, swelling of the extremities, weight gain, shortness of breath, chest pain, increased or decreased heartbeat, or irregular heartbeat ... Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit ....” During an interview on 11/30/2021 at 3:00 PM, when queried where the record evidenced the physician was notified for a potential major interaction, clinical manager B indicated if a DRR was completed and evidenced findings of major drug interactions, it would have been faxed to the physician, and also indicated the record failed to evidence anything was faxed to the physician. 8. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, and certification period 10/25/2021 – 12/23/2021. Record review evidenced a document dated and signed by RN I on 10/22/2021, titled “... Recertification ....” This document indicated the patient’s medication profile included 16 medications, which included sertraline/Zoloft (antidepressant), and mirtazapine (antidepressant); and stated “... Drug Regimen Review ... I [RN I] attest to all of the following ... I have not identified major potential or actual drug reaction ....” A Drugs.com web-based referenced on 12/01/2021 at 11:50 AM, titled “Drug Interaction Report” indicated 1 major drug interaction between sertraline/Zoloft and mirtazapine; and stated “... This report displays the potential drug interactions for ... 16 drugs ... Major ... Using sertraline together with mirtazapine can increase the risk of a rare but serious condition called the serotonin syndrome, which may include symptoms such as confusion, hallucination, seizure, extreme changes in blood pressure, increased heart rate, fever, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea. Severe cases may result in coma and even death ... Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit ....” 9. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, and certification period of 10/30/2021 – 12/28/2021. Record review evidenced a document dated and signed by RN G on 10/26/2021, titled “... Recertification ....” This document indicated the patient’s medication profile included 14 medications, including acetaminophen (pain relief). The record also evidenced the patient regularly consumed alcoholic beverages. A Drugs.com web-based referenced on 12/01/2021 at 11:50 AM, titled “Drug Interaction Report” indicated 1 major drug interaction between acetaminophen and ethanol (contained in alcoholic beverages); and stated “... This report displays the potential drug interactions for ... 14 drugs ... Major ... Ask your doctor before using acetaminophen together with ethanol. This can cause serious side effects that affect your liver. Call your doctor immediately if you experience a fever, chills, joint pain or swelling, excessive tiredness or weakness, unusual bleeding or bruising, skin rash or itching, loss of appetite, nausea, vomiting, or yellowing of the skin or the whites of your eyes. If your doctor does prescribe these medications together, you may need a dose adjustment or special tests to safely take both ... Highly clinically significant ... Avoid combinations; the risk of the interaction outweighs the benefit ....” During an interview on 11/22/2021 at 11:14 AM, when queried about the patient’s history, licensed practical nurse (LPN) E indicated the patient was known to consume alcohol regularly, and the patient’s family brought it to the patient. During an interview on 12/07/2021 at 10:50 AM, when asked if consumption of alcohol could potentially interact with medications, administrator/RN A stated “...Yes ....”, and indicated the patient was an alcoholic. 10. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, and certification period of 12/07/2021 – 02/04/2022. Record review evidenced a document dated and signed by RN G on 12/07/2021, titled “... Start of Care ....” This document indicated the patient’s medication profile included 2 medications. A Drugs.com web-based referenced on 12/14/2021 at 7:30 AM, titled “Drug Interaction Report” evidenced 0 major drug interactions for drugs identified on 12/07/2021, comprehensive assessment. A document submitted on 12/14/2021 at 11:48 AM, dated and signed by RN G on 12/13/2021, titled “Physician Supplemental Order” stated “... Bactrim [antibiotic] ... 1 Oral Tablet Twice a Day ... Augmentin [antibiotic] ... 1 Oral Tablet Twice a Day ....” During an interview on 12/14/2021 at 11:51 AM, when queried if a DRR was completed for the comprehensive assessment on 12/07/2021, clinical manager B stated “... No ... not an initial one ....” When queried if a DRR was completed for the new medications added on 12/13/2021, clinical manager B stated “... No ... not yet.” 11. During an interview on 11/30/2021 at 12:30 PM, when queried how often a DRR was performed, clinical manager B indicated whenever there was a change in medication, at least every 60 days, and administrator/RN A performed them. When queried to describe the procedure for performing a DRR, clinical manager B indicated when the clinician in the field identified a medication change, she wrote an order, the order went into the medical record, an order was generated if need be; and components of a DRR were drug interactions, allergies, duplication, and availability for administration. She also indicated the physician was supposed to be notified for interactions or anything on the DRR list via fax. When queried where it Where it was documented, clinical manager B indicated it might be on a case conference or maybe on an order generated, the agency had a “built in” interaction checker in its software, they paid for each user who had interactions checker privileges, it was very expensive, and only certain people had this privilege. 12. During an interview on 12/13/2021 at 1:46 PM, when queried about the DRR process and who had access to the software interaction checker, clinical manager B, RN I did not have access to interaction checker, and they (clinicians) were supposed to check into the office. When queried who checked for drug interactions, clinical manager B indicated administrator/RN A and office assistant D (not an RN). 17-14-1(a)(1)(B)

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the registered nurse (RN) and/or physical therapist (PT) failed to ensure the comprehensive assessment included the patient’s primary caregiver’s (and/or other available supports) willingness, ability to provide care, and/or their availability for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment for each patient ... documented in the patient’s clinical record ... including at least the following ... patient’s and family/caregiver’s educational needs, ability, motivation, and readiness to learn ... Patient and family/caregiver support systems and the type of care the family/caregiver is available, capable, and willing to provide ... Involvement of ... individuals or organizations ....” 2. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis of stage 2 pressure ulcer of left buttock, and other pertinent diagnosis of stage 2 pressure ulcer of right buttock. Record review evidenced a document dated and signed by RN G on 10/29/2021, titled “... Recertification [comprehensive assessment] ....” This document indicated the patient was disoriented, dependent for care, chairbound, required wound care twice weekly, had a primary caregiver, resided in an assisted living facility (ALF), and ALF staff was not permitted to perform wound care. The document failed to evidence the type of care the primary caregiver was capable of, if care was correctly provided, his/her availability, or who provided wound care if needed when agency staff was not present if the dressing became compromised. 3. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, evidenced a document titled “Home Health Certification and Plan of Care” for certification period 9/24/2021 – 11/22/2021, evidenced a primary diagnosis of dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses included insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) inserted on 9/21/2021, encounter for attention to gastrostomy (g tube); and a document titled “Home Health Certification and Plan of Care” for certification period 11/23/2021 – 1/21/2021, which evidenced a new primary diagnosis pressure ulcer of sacral (lower back) region (11/02/2021), and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) (11/02/2021), dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) (11/02/2021), and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) (10/12/2021). A document dated and signed by RN I on 09/24/2021, titled “... Start of Care [comprehensive assessment] ....” indicated the primary caregiver was the patient’s family member, family member was staying with patient to help, the patient lived in an ALF, and failed to evidence the caregiver’s ability to correctly administer nutrition, fluids, or medications through the g tube, or check for correct placement, and failed to evidence if the ALF provided any care. A document dated and signed by RN I on 11/18/2021, titled “... Recertification ....” indicated the family member was staying with patient, family member was primary caregiver, and failed to evidence caregiver ability/competency to perform care, or caregiver psychological/emotional status or willingness to continue to provide the complex care the patient required. A home visit was observed on 11/18/2021 at 12:55 PM, with RN I and the patient’s family member present. During the visit, RN I failed to assess the family member’s ability to correctly perform the complex care the patient required. During this time, the family member indicated they were very overwhelmed with taking care of the patient and would like more help. 4. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis of Alzheimer’s disease, unspecified, secondary diagnoses dementia, repeated falls, essential (primary) hypertension (high blood pressure), type 2 (adult onset) diabetes, major depressive disorder, anxiety disorder (unspecified), long term (current) use of aspirin, and history of falling. Record review evidenced a document dated 08/20/2021, and signed by PT J on 08/30/2021, titled “... PT Start of Care ....” This document indicated the patient resided at ALF Q, was unable to take medications unless administered by another person, non-agency caregivers provided assistance for supervision and safety, and failed to evidence who the primary caregiver was, their availability, or extent of care provided. 5. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis of Alzheimer’s disease (unspecified), secondary diagnoses included dementia, repeated falls, major depressive disorder, anxiety disorder (unspecified), essential (primary) hypertension (high blood pressure), hyperlipidemia (high cholesterol (unspecified), hypothyroidism (unspecified), and history of falling. Record review evidenced a document dated 10/29/2021, and signed by PT J on 11/02/2021, titled “... PT Start of Care ....” This document indicated the patient had a history of falls, lived in an ALF, dependent on others for care, unable to feed self, non-agency caregivers provided assistance for supervision and safety, unable to take medications unless administered by another person, and failed to evidence which ALF the patient resided at, who the primary caregiver was, their availability, or extent of care provided; and failed to evidence what care the ALF provided. A home visit was observed on 11/18/2021 at 9:45 AM, at ALF Q, with PT M present. The patient presented slumped over in the chair, with greater than 75% of the patient’s breakfast meal and a full glass of juice in front of them on a table, food droppings on their clothing, and appeared to be sleeping. PT M indicated the patient probably needed help with meals, PT would let the ALF staff know, the patient was unable to follow a home exercise program (HEP), and the patient’s family member was their primary caregiver, who was not present during the visit. During an interview on 11/18/2021 at 10:05 AM, when queried how ALF Q’s staff knew what HEP exercises to work on with the patient when no agency PT was present, person U (ALF Q’s director of nursing) needs person identifier indicated it was on the facility care plan, the care plan was observed, and evidenced only an entry dated in July 2021, for PT to evaluate and treat. 6. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, and a primary diagnosis of type 2 (adult onset) diabetes with foot ulcer (open wound). Record review evidenced a document dated and signed by administrator/RN A on 09/08/2021, titled “... Start of Care ....” The document indicated the patient lived in an ALF, blood sugar was checked before meals and at bedtime, indwelling urinary catheter, unable to take oral or injectable medications unless administered by another person, non-agency caregivers provided assistance for supervision and safety, and failed to evidence who the primary caregiver was, their availability, or extent of care provided, or who managed wound care/indwelling urinary catheter when agency staff not present. During an interview on 12/01/2021 at 2:45 PM, when queried, person V (director of nursing at ALF V) indicated their staff administered the patient’s medications, and ALF V staff couldn’t manage indwelling urinary catheters. 7. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis of non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses of non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), and personal history of COVID-19 (04/27/2021). Record review evidenced a document dated and signed on 10/22/2021, by RN I titled “... Recertification ....” This document indicated the patient had 4 or more stasis ulcers (wounds caused by impaired circulation), had lower extremity swelling, resided at ALF L, and previously lived at home, had a fall, and sustained a brain injury. The document failed to evidence who the primary caregiver was, their availability, or extent of care provided, who performed wound care when no agency staff present; and failed to evidence what care ALF L staff provided. During an interview on 12/07/2021 at 10:50 AM, when queried who was responsible to manage wounds, administrator A indicated (patients #6 and 7) went to the wound clinic weekly, and questioned if it was her responsibility. 8. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis of chronic obstructive pulmonary disease (lung disease), secondary diagnoses included hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), congestive heart failure, non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow), personal history of COVID-19 (07/02/2021), and personal history of pneumonia (07/02/2021). Record review evidenced a document dated and signed on 10/26/2021, by RN G titled “... Recertification ....” This document indicated ALF L staff was not permitted to perform wound care, and failed to evidence if the patient had a primary caregiver, their availability, or extent of care provided, and failed to evidence what care ALF L staff provided. During an interview on 12/07/2021 at 10:50 AM, administrator A indicated ALF L staff did wound care on an as needed (PRN) basis. 9. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis of unspecified open wound, right lower leg, subsequent encounter, secondary diagnoses of unspecified open wound, left lower leg, subsequent encounter, unspecified juvenile rheumatoid arthritis, essential (primary) hypertension (high blood pressure), adjustment disorder with depressed mood, hypothyroidism (unspecified), unspecified urinary incontinence, and history of falling. Record review evidenced a document dated and signed on 06/09/2021, by administrator/RN A titled “... Recertification ....” This document indicated the patient had a primary caregiver, was chairfast (ability to walk severely limited or non-existent, cannot bear own weight and/or must be assisted into chair), was oriented, continued to have multiple falls, and lived at ALF Y. The document failed to evidence the primary caregiver’s availability, or extent of care provided; or the scope of care ALF Y provided. 10. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis of COVID-19, other diagnoses included pneumonia due to COVID-19, acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood), permanent atrial fibrillation (irregular heart rhythm), dilated cardiomyopathy (weak heart muscle which causes inability to pump blood efficiently throughout the body), heart failure, end stage renal (kidney) disease, dependence on renal dialysis, diabetes, major depressive disorder, and long term use of anticoagulants (blood thinners). Record review evidenced a document dated and signed on 04/30/2021, by administrator/RN A titled “... Start of Care ....” This document indicated the patient had a primary caregiver, and failed to evidence the primary caregiver’s availability, ability, or extent of care they provided. During an interview on 12/02/2021 at 1:56 PM, family indicated the patient could hardly walk, and when they tried to assist the patient to the bathroom, they would collapse and/or faint. A document dated and signed by person AA (contract therapy agency BB) on 05/03/2021, titled “Physical Therapy Evaluation ... Initial Evaluation” failed to evidence who the primary caregiver was, or the caregiver was assessed for ability, or extent of care he provided. 11. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis of cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses of pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, and bed confinement status. Record review evidenced a document dated and signed by RN I on 11/07/2021, titled “... Start of Care ....” This document indicated the patient lived with family, family member was the primary caregiver, the patient had a left upper arm single lumen PICC (peripherally inserted central catheter line- a tube inserted in a smaller vein in the arm, extending up to a larger vein, to administer intravenous treatments), received IV (intravenous) medication and flushes 3 times weekly, needed complex wound care daily, and the patient needed assistance for all activities. The document failed to evidence the primary caregiver’(s) extent, availability, or competency of care provided, or who performed wound care when no agency staff was present. During an interview on 12/02/2021 at 1:16 PM, the patient’s primary caregiver indicated he/she “did” the IV treatments on days the nurse wasn’t there, and he/she provided wound and personal care/bathing for the patient, the patient had 6 wounds, and the nurse was going to call the family member on Saturday, 12/04/2021, to “walk him/her through” the procedures for wound care on the patient. 12. Record review for patient #11 was completed on 12/15/2021, start of care 12/07/2021, certification dates 12/07/2021 – 02/04/2022, primary diagnosis of pressure ulcer of sacral (lower back) region, unstageable, other diagnoses of pressure ulcer of left buttock, unstageable, cellulitis of lower limb, and unspecified dementia without behavioral disturbance. Record review evidenced a document dated and signed on 12/07/2021, by RN G. This document indicated the patient resided at ALF K, had swelling of the legs, was oriented but forgetful, confused in new or complex situations only, but then indicated patient failed to recognize familiar persons/places, inability to recall events of last 24 hours, significant memory loss so that supervision was required, had open, draining wounds, was totally dependent for all care, was chairfast, family member was emergency contact, but failed to evidence if the family member was the primary caregiver, who performed wound care when no agency staff was present, or ALF K staff extent, frequency or availability of care provided. During an interview on 12/13/2021 at 11:15 AM, when queried if the patient could transfer herself, administrator A stated “... No, the assisted living people do it ....” When queried if there was a concern that the patient was too acute (complex needs) for an assisted living facility, administrator A stated “... Yeah, possibly ....”, and indicated the patient’s family member’s availability, or what they did for the patient was not included on the comprehensive assessment dated 12/07/2021. During an interview on 12/15/2021 at 12:45 PM, when queried who patient #11’s primary caregiver was, administrator A stated “... The assisted living is the primary caregiver ....” When queried who was responsible for wound care when agency was not present, administrator A stated “... There’s an order for the facility to change ... if soiled or dislodged ....”

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure the registered nurse (RN) assesses or reassessed 8 of 8 patients who experienced and/or were reported to have a change in condition which resulted in new and/or worsening symptoms, new and/or worsening wounds, wound infection(s), aspiration pneumonia, emergency department (ED) visit(s), and/or hospitalization(s), from a total sample of 11 records reviewed (#1, 2, 3, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... the assessment will be patient specific and comprehensive ... will be completed ... [for] ... Significant change in condition ... must be conducted by a registered nurse ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Ongoing Assessments” stated “... Re-assessments should focus on ... Changes in patient condition ....” 3. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Reassessments/Recertification” stated “... The comprehensive assessment must be updated and revised ... at least every 60 days, or more often as warranted by the condition of the patient ... assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician ... will be completed within the mandated timeframes ... must include ... any changes in patient status ....” 4. A Johns Hopkins web-based reference, https://www.hopkinsmedicine.org/gec/series/wound_care.html, reviewed on 12/15/2021, titled “Wound and Pressure Ulcer Management”, stated “... [pressure ulcer] ... Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed ... Measurement ... Length – from top edge to the bottom edge (head to toe) at longest point ... Width – from edge to edge perpendicular to the length at widest point ... Depth – straight in, perpendicular to the base, at deepest point ... Necrosis/Eschar - Black, brown or tan devitalized tissue that adheres to the wound bed or edges and may be firmer or softer than the surrounding skin ... Slough - Soft, moist avascular tissue that adheres to the wound bed in strings or thick clumps; may be white, yellow, tan or green ....” 5. A Drugs.com web-based reference, https://www.drugs.com/cdi/calmoseptine.html, reviewed on 12/15/2021, stated “... Calmoseptine ... It is used to protect skin from wetness, urine, or stools ... to treat diaper rash ... to treat minor cuts, scrapes, or burns ... Do not put on open or deep wounds ... infections ....” 6. A Centers for Disease Control and Prevention web-based reference, https://www.cdc.gov/groupastrep/diseases-public/Cellulitis.html, reviewed on 12/15/2021, stated “... Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin. If untreated, it can spread and cause serious health problems. Good wound care and hygiene are important for preventing cellulitis ....” 7. Record review for patient #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis of stage 2 pressure ulcer (wound caused by unrelieved pressure, no deeper than the layers of the skin, and includes intact or ruptured blisters) of left buttock, and other pertinent diagnosis of stage 2 pressure ulcer of right buttock. Record review evidenced a comprehensive assessment dated and signed by RN G on 10/29/2021, titled “... Recertification ....” This document indicated the patient had a wound on the right (R) buttock, it measured 3.0 cm (centimeters) (in length) x (by) 0.5 cm (wide) x /= (greater than or equal to) the diameter of a quarter (2.5 cm), the depth was approximately >/= the diameter of a quarter, there was undermining present at the top of the wound, a large amount of thick, creamy drainage was present, and the patient yelled out in pain during wound care. During this time, LPN H indicated administrator/RN A was the RN case manager, the wound wasn’t doing any better, and the wound appeared more necrotic (dead, black tissue) than before. During an interview on 11/30/2021 at 1:30 PM, when queried, clinical manager B indicated the RN supervisor should be notified for signs/symptoms of infection, new or worsening wound(s), and an RN should follow up on antibiotic efficacy. When queried at what point would the RN go back out to assess the worsening wound(s), clinical manager B indicated it should have occurred on the next visit after the antibiotics were ordered, and when asked if an RN did a follow up re-assessment, clinical manager B stated “... No ....” and indicated the last RN visit was 10/29/2021, (for the recertification comprehensive assessment). During an interview on 12/07/2021 at 10:50 AM, with regard to the nursing visit completed on 11/12/2021, by LPN H, administrator/RN A indicated LPN H documented the wound was worse, and even if the wound bed was worse, the wound was decreasing in size, so she wasn’t sure why an RN would need to go out to re-assess the patient, and asked how quickly a nurse was expected go back and assess a patient. Additionally, she indicated the antibiotics were ordered on 11/17/2021, and clinical manager B indicated the antibiotics were ordered on 11/15/2021. 8. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, evidenced a document titled “Home Care Certification and Plan of Care” for certification period 9/24/2021 – 11/22/2021, evidenced a primary diagnosis of dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) inserted on 9/21/2021, encounter for attention to gastrostomy (g tube), atherosclerotic heart disease (hardening of the arteries), hypertensive chronic kidney disease (high blood pressure caused by the narrowing of your arteries that carry blood to your kidneys), end stage renal disease (kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life), dependence on dialysis, and history of old myocardial infarction (heart attack) and coronary angioplasty (a medical procedure in which a balloon is used to open a blockage in an artery in the heart); and a document titled “Home Care Certification and Plan of Care” for certification period 11/23/2021 – 1/21/2021, primary diagnosis pressure ulcer of sacral (lower back) region (11/02/2021), and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) (11/02/2021), dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) (11/02/2021), and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) (10/12/2021). An agency document dated and signed by RN I on 9/24/2021, titled “... Start of Care ... [initial comprehensive assessment] ....” indicated the patient was able to take in nutrients orally, received supplemental tube feedings, received some medications via g tube, was on a renal diet (low in sodium, phosphorous, and protein, and also emphasizes the importance of consuming high-quality protein, and usually limiting fluids) with 1500 ml (milliliter) fluid restriction, received 8 ounces of Nepro (supplemental feeding) via g tube QID (4 times daily); and failed to indicate the nurse assessed the patient's ability to swallow food or fluids to determine active aspiration, assessed correct placement of the g tube, checked for gastric residual, or assessed patient/caregiver competency for administration of supplemental feedings and medications administered via g tube. Agency documents dated and signed by RN I on 9/28/2021 and 9/30/2021, titled “... SN Visit Note” failed to evidence the nurse assessed the patient's ability to swallow food or fluids to determine active aspiration, assessed correct placement of the g tube, checked for gastric residual, or assessed patient/caregiver competency for administration of supplemental feedings and medications administered via g tube. An agency document dated and signed by RN I on 9/30/2021, titled “... SN Visit Note” also indicated the patient complained of nausea/vomiting, and failed to evidence the nurse observed/assessed tolerance to oral food/fluid intake. Hospital D documentation dated 10/12/2021, indicated the patient was hospitalized on 10/04/2021, for nausea/vomiting due to tube feedings and hyponatremia most likely secondary to excessive free water flushes with tube feeds and was ordered NPO (take nothing orally/by mouth), and was discharged to home on 10/08/2021. A document dated and signed by RN I on 10/12/2021, titled “... Resumption of Care ....” (comprehensive assessment) indicated the nurse assessed crackles in the patient’s lower lungs (the small air sacs in the lungs fill with fluid), [the patient] had shallow breathing, diet included renal diet, 1500 ml fluid restriction, and supplemental g tube feedings 4 times daily; and failed to evidence the nurse assessed the patient's ability to swallow food or fluids to determine active aspiration, assessed correct placement of the g tube, checked for gastric residual, or observed/assessed patient/caregiver competency for administration of supplemental feedings and medications administered via g tube. During an interview on 12/07/2021 at 1:54 PM, when queried why the resumption of care (comprehensive assessment) occurred 4 days after the patient was discharged from the hospital (discharge date of Friday, 12/08/2021), administrator/RN A stated, “ I don’t think we even knew she was home ....”, and indicated she faxed (hospital D) on Monday, 10/11/2021, for patient’s hospitalization records, received them on 10/12/2021, and office assistant D called the hospital every day to check status. During this time (2:49 PM) office assistant D indicated she didn’t call every day, and administrator/RN A indicated they didn’t check patient status on weekends. When asked why the comprehensive assessment dated 10/12/2021, indicated the physician ordered the resumption of care to occur on 10/12/2021, administrator/RN A and clinical manager B both indicated they didn’t know. During an interview on 12/08/2021 at 11:00 AM, family verbally consented for surveyor to screen shot text messages between herself and RN I. A text message was observed sent from family to RN I on 10/08/2021 at 1:24 PM which stated “[patient] is going to be discharged around 3 [PM]”, a text reply sent from RN I to family at 1:26 PM stated “Sounds good. Please ask them to fax us a resume order ....”, and a text sent from RN I to family at 1:44 PM, stated “I can be out to see you Monday [10/11/2021] afternoon. Call me over the weekend if you have any questions ....” and indicated they did not refuse a nursing visit for the patient on 10/14/2021. An agency document dated and signed by RN I on 10/14/2021, titled “Missed visit Note” indicated the family requested cancellation of nursing visit same date due to multiple other agency disciplines’ visits scheduled for same day, and the patient had dialysis on 10/15/2021. The document evidenced the physician was notified of the missed visit, but failed to evidence a visit was offered for another day of that work week. An agency document dated and signed by RN I on 10/19/2021, visit time 12:30 PM – 1:30 PM, titled “... SN Visit Note”, indicated the patient did not go to dialysis this date due to fatigue, nurse assessed “significant decline in respiratory status”, “ patient’s respiratory status declining”, nurse requested for family to transport to ED (emergency department), but family indicated she would take the patient to urgent care. An agency document dated and signed by occupational therapist (OT) K on 10/19/2021, visit time 1:35 PM – 2:20 PM, titled “... OT Eval and CP [care plan]” indicated the patient’s respirations were regular, the patient was stable, and failed to evidence the patient exhibited any respiratory complications. During an interview on 12/08/2021 at 9:55 AM, at dialysis center F, an untitled dialysis calendar was submitted by facility staff person G, which indicated the patient was not scheduled for dialysis on 10/19/2021, and the patient’s regular schedule was every Monday, Wednesday, and Friday. A document dated and signed by RN I on 10/22/2021, titled “... SN Visit Note” evidenced a nursing visit was made from 12:30 PM – 1:00 PM, the patient was on a general/regular diet, had supplemental g tube feedings, and failed to evidence the patient was on a 1500 ml fluid restriction. The document also evidenced the patient had increased weakness, nausea and vomiting, shortness of breath with onset of productive cough with copious amounts of mucus, and family was going to take the patient to urgent care. During an interview on 12/08/2021 at 12:52 PM, person H (urgent care H staff) indicated the patient was checked in at the facility on 10/22/2021 at 1:07 PM, and was sent to the ED at 1:35 PM. During an interview on 12/08/2021 at 11:00 AM, family indicated RN I did not make a nursing visit on 10/22/2021, no one was there that day, which observation was made of a text from RN I on 10/21/2021 at 2:44 PM, that stated “ ... I’ll see you guys next week”, a text message on 10/22/2021 at 9:14 AM, from family to RN I, which stated, “Rough morning as soon as the food hit her stomach she started vomiting ....”, a text message from RN I to family at 11:45 AM, stated “Were you able to get in touch with md [sic]?” and a text message from family to RN I at 2:09 PM, which stated “At the ER [emergency room] doctor said her lungs are horrible ....” A hospital D document titled “History and Physical Reports” indicated the patient was admitted 10/22/2021 and discharged on 10/31/2021. Hospital paperwork indicated family needed to be taught how to do tube feeds properly and prevent any further aspiration. An agency document dated and signed by RN I on 11/02/2021, titled “... Resumption of Care ....” indicated the patient was to be NPO, and failed to evidence the registered nurse assessed compliance with NPO status, proper g tube placement, gastric residual, or patient/caregiver competency with administration of tube feedings. An agency document dated and signed by RN I on 11/09/2021, titled “... SN Visit Note” evidenced the patient was on a regular diet with supplemental tube feedings, assessed crackles in bilateral bases, and nausea/vomiting. A text message was observed from family to RN I on 11/10/2021 at 8:38 AM, which stated “Well we are back to square one. [He/She] woke me up at 5am gave him/her 2 oz [ounces] formula tylenol [sic] and his/her new nausea medicine it no more hit his/her stomach and he/she vomited it all up. [He/She] is coughing a lot and doesn’t want to go to dialysis.”, a text from RN I to family at 8:50 AM, stated “... I just want him/her comfortable and it kills me we can’t help him/her”, and additional texts that indicated the patient didn’t want to go to the ED, the nurse indicated family could ask for a suppository for the nausea, asked family if the patient was still having rib cage and back pain, and failed to evidence the nurse asked to make a home visit to assess the patient. On Thursday, 11/11/2021 at 8:00 AM, family texted RN I to inform her the patient was at the ED (hospital D), and she returned home the same day with new medication orders. On Wednesday, 11/17/2021 at 12:25 PM, RN I texted family and stated “So there is a [sic] Indiana state surveyor here doing a survey for At Home Quality Care ... You do not have to say yes it’s your choice”, a text from family to RN I at 12:30 PM, which stated, “Yes that [sic] fine”, and a text from RN I to family at 12:32 PM, which stated “Do you care if I stop over today just to look at the [home] folder? I have to make sure the medication sheets and plan of care are n [sic] there and ... vital signs so we pass the survey ....” The clinical record failed to evidence the RN made another home visit after 11/09/2021, until 11/18/2021. A home visit observation occurred on 11/18/2021 at 12:55 PM, with RN I present. This was a recertification comprehensive assessment visit. The patient presented seated upright in a living room chair, was coughing uncontrollably, tears streamed down their face, and family indicated the patient just had some sips of hot cocoa. During this time, RN I assessed crackles in bilateral lung bases, and indicated she would refer SLP (speech language pathologist) services to evaluate (SLP was not referred upon start of care on 9/24/2021), indicated the agency did not offer social worker services, it would be nice, there were lots of needs for social work services, the patient didn’t have any current open skin areas, had an open area on their coccyx around the end of October, but it was resolved, and family used desitin (diaper rash ointment) as a preventative. When the nurse was asked to assess the patient’s coccyx near the end of the visit, a stage 2 pressure ulcer was observed, approximately the size of a quarter, with a small amount of yellow slough on part of the wound bed. The nurse indicated she would notify the physician and get an order for mepilex (foam dressing), and she would stop by the patient’s home tomorrow (11/19/2021) to drop off wound supplies. During this time, family indicated the nurse never watched the family member administer tube feedings or administer medications, was never told the patient had a fluid restriction, or to have nothing by mouth, and the patient finished a course of antibiotics on 11/14/2021. A document titled “... SN Visit Note” evidenced a nursing visit was made on 11/19/2021 by RN I from 3:15 PM – 4:00 PM, and vital signs and other physical assessments were performed. During an interview on 12/08/2021 at 11:00 AM, family indicated RN I did stop by on 11/19/2021, but she just did the dressing and left. When asked if she checked the patient’s vitals or performed any other assessments on the patient, family indicated she did not. During an interview on 12/1/2021 at 1:35 PM, family indicated they informed the registered nurse on 11/21/2021, that the patient's blood pressure was “running high”, the nurse did not make a visit to assess the patient, the nurse texted to check on the patient's blood pressure on 11/22/2021, during which time family indicated they didn't write the patient’s blood pressure readings down, indicated to the nurse "something has changed, we took a big step backwards", the nurse did not make a home visit to assess the patient, and the patient was subsequently seen in the ED, hospitalized 11/24/2021- 11/25/2021 for hypertension and NSTEMI (a type of heart attack involving partial blockage of one of the coronary arteries) with stent placement. At that time, the nurse texted back to have family let her know when the patient got home. On 11/27/2021, family texted the nurse to inform patient was home from hospital, and the nurse replied to let her know when the family member would like a visit, but did not offer to visit on that date. When asked if the family member would have accepted a visit from the nurse if she offered to come on 11/27/2021, family said "Of course". As of 12/1/2021, the patient was not seen by the nurse or SLP. During an interview on 12/3/2021 at 12:42 PM, when queried if the agency “front loaded” nursing visits (an increased nursing frequency of weekly visits based on patients who had complex and/or high-risk needs), clinical manager B stated “Yes ....”, and indicated it was based on diagnosis, high- tech needs such as IV (intravenous) treatment, wound vac (complex negative pressure wound therapy), or CHF (congestive heart failure). When queried if g tube patients were front loaded, clinical manager B indicated it would depend on if the patient/family already knew how to care for it. When queried if a patient would be front loaded for a patient with a new g tube, such as 3 days old, should be front loaded, clinical manager B stated, “Yes, definitely.” During an interview on 12/07/2021 at 10:50 AM, because of the immediate jeopardy (IJ) announced on 12/06/2021, clinical manager B indicated she wanted to discuss patient #2, and asked administrator/RN A to “take over the conversation”, as she knew the patient better. administrator/RN A failed to respond, and when asked again by clinical manager B, administrator/RN A failed to respond. Clinical manager B then indicated that when she previously indicated the patient should have been front loaded, she thought it was important to note the patient went to dialysis 3 times per week. Administrator/RN A then indicated family said he/she didn’t want the patient to be seen over the holiday weekend (11/25/2021 -11/28/2021), and the patient was non-compliant with attending dialysis. When queried why the patient was non-compliant, she indicated she didn’t know. The clinical record failed to evidence the nurse attempted to schedule a visit 11/25/2021 – 11/28/2021 or evidenced the patient/family declined a visit during same timeframe. During an interview on 12/08/2021 at 9:55 AM, at dialysis center F, facility staff person G indicated the patient was compliant with receiving dialysis treatments. 9. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, evidenced a document titled “Home Care Certification and Plan of Care” with primary diagnosis of Alzheimer’s disease, unspecified, secondary diagnoses of dementia, repeated falls, essential (primary) hypertension (high blood pressure), type 2 (adult onset) diabetes, major depressive disorder, anxiety disorder (unspecified), long term (current) use of aspirin, and history of falling, indicated the patient received physical therapy (PT) and occupational therapy (OT) services. An agency document dated and signed 09/09/2021, by certified occupational therapy assistant (COTA) L, titled “Missed Visit Note” stated “... Reason Visit not Made: Patient Hospitalized ... Missed Visit Comments: Patient hospitalized yesterday after going non responsive [sic] on an outing ... Persons notified ... Yes ... [administrator/RN A] ... Date Notified ... 9/9/2021 ....” The record failed to evidence an RN assessed the patient prior to the resumption of therapy services. A document received from ALF Q on 12/06/2021, titled “[hospital D] ... Patient Discharge Instructions” evidenced the patient was seen and released from the emergency department (ED) on 09/08/2021, the patient had changes made to his/her medication regimen as a result of the (ED) visit, and Xanax (antianxiety) and aspirin low dose (blood thinner) were discontinued. The agency’s record failed to evidence these changes. A document received from ALF Q on 12/06/2021, dated 09/08/2021, titled “View Progress Note” stated “... resident coming back from an outing and became non responsive [sic] when arrived to facility while in bus ... resident did c/o [complain of] chest pain prior to going non responsive ... 911 called to transport ....” A document received from hospital D on 12/06/2021, titled “Emergency Documentation” evidenced the patient’s blood sugar was “in the 70’s” when EMS (emergency medical services) arrived on scene, was diagnosed with cardiomegaly with moderate interstitial prominence (enlarged heart), syncope (fainting), and congestive heart failure while in the ED. The patient’s clinical record failed to evidence these changes. An agency document dated and signed by PT J on 09/10/2021, titled “... PT Revisit Note” stated “... Medications reviewed ... No ....” During an interview on 12/06/2021 at 1:13 PM, when queried if an RN should perform a comprehensive assessment prior to continuation of services for a patient who received therapy services only, if a COTA documented a missed visit due to the patient being hospitalized the previous day after going unresponsive at an outing, administrator/RN A indicated an RN assessment visit wasn’t required for the patient after he/she was found unresponsive. 10. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis of chronic obstructive pulmonary disease (lung disease), hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow) and dependence on supplemental oxygen. Record review evidenced a comprehensive assessment dated and signed by RN G on 10/26/2021, titled “... Recertification ....” This document indicated 2 wounds: a stasis ulcer (L) leg, black wound bed, (4.0 cm x 3.0 cm x 0.3 cm), no odor; and an open wound (L) leg, pale pink wound bed, (2.1 cm x 1.6 cm x 0.3 cm) small amount serosanguinous drainage, no evidence of infection documented, assisted living facility (ALF) L was not permitted to perform wound care, pain rated by patient as “8” [in a scale of 0 – 10, with 0 being no pain and 10 the most severe] in (L) leg, and stated “... numeric [pain] scale ... 0: None ... 7-9: requires MD [physician] intervention ....” An agency document dated and signed by LPN E on 11/01/2021, titled “... SN Visit Note” indicated the (L) leg stasis ulcer and (L) leg open wound morphed into one larger wound (7.0 cm x 4.0 cm x 0.3 cm), (L) leg calf edema (swelling), which measured 14 inches diameter, skin was shiny and pale around the wound; and an open wound to shin continued (without orders to treat). An agency document dated and signed by LPN E on 11/03/2021, titled “... SN Visit Note” indicated the calf edema increased to 15 inches diameter, the (L) leg dressing was saturated with drainage, the wound declined, patient had increased pain, was sent to ED for evaluation. A hospital D document dated 11/04/2021, titled “History and Physical Reports” indicated the patient was admitted on 11/03/2021, discharged on 11/08/2021, indicated the patient complained of increased pain, redness and swelling to (L) lower leg, which spread up back of leg, for 2 days; and was admitted with cellulitis, which required treatment with intravenous (IV) antibiotics. The document also indicated the patient was a current daily beer drinker. A hospital D document dated 11/08/2021, titled “Discharge Documentation” indicated the patient’s new medications included Levaquin (antibiotic) orally for 7 days, and tramadol (pain medication) every 6 hours as needed for pain. An agency document dated and signed by administrator/RN A on 11/09/2021, titled “... Resumption of Care ....” evidenced no wound orders were sent home with the patient from hospital D, she was unable to obtain orders, so she covered the wounds with dry gauze and wrapped the wounds with gauze rolls, and the patient had an appointment at wound clinic M on 11/11/2021. Additionally, the patient’s stated pain was “7”, (L) lower leg wound (8.0 cm x 5.1 cm x 0.3 cm), wound bed brown, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed pale pink, and 0.5 cm x 2.0 cm x 0.1 cm), no wound bed description, both had drainage; and stated “... Patient has been found with a lot of beer in her room and has become a concern to facility ....” An agency document dated and signed by LPN E on 11/10/2021, titled “... SN Visit Note” indicated (L) lower leg wound (8.0 cm x 5.1 cm x 0.3 cm), wound bed now black, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed now gray, and (0.5 cm x 2.0 cm x 0.1 cm), wound bed gray, both had drainage, patient rated pain at “8”, and stated “... Called wound clinic and patient was given an appointment for 11/11 [2021] as wounds need attention and orders ... Patient is peeling the skin ... precautioned on scratching with hangers and other objects as [patient] has done in the past ... wounds 1 and 2 have increased and wound bed does not present with any viable [living] tissue ... Wound burned and hurt while cleansing ... No wound care orders ... covered with gauze and taped in place ... Patient stated he/she is ready to just have his/her leg cut off ... complained about being weak and tiring out very quickly ....”. The document indicated the agency RN supervisor was informed, but the clinical record failed to evidence an RN re-assessment was completed. An agency document dated and signed by administrator/RN A on 11/11/2021, at 8:44 PM, titled “Physician Supplemental Order” evidenced wound treatments orders which stated “... Order Received: 11/12/2021 ... lower left leg venous stasis ulcers ... Cleanse with normal saline, apply betadine to wound, apply silver alginate [aquacel Ag+], dry gauze dressing and compression dressing (Tubi grip) three times weekly or PRN [as needed] if dressing becomes soiled or dislodged ....” An agency document dated and signed by LPN E on 11/12/2021, titled “... SN Visit Note” indicated (L) lower leg wound (8.0 cm x 5.1 cm x 0.3 cm), wound bed black, gray, brown, and tan, debrided by wound clinic M on 11/11/2021, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed gray, and (0.2 cm x 0.9 cm x 0.1 cm), wound bed pink, both had drainage, and patient rated pain at “8”. An agency document dated and signed by LPN E on 11/15/2021, titled “... SN Visit Note” indicated (L) lower leg wound (7.6 cm x 5.1 cm x 0.3 cm), wound bed black, gray, brown, and tan, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm), wound bed gray, and (0.5 cm x 0.2 cm x 0.1 cm), wound bed white, both had drainage, patient rated pain at “8”, wounds were painful to touch, patient squirmed during care, which made wound care difficult to perform, and ALF staff reported patient was consuming alcoholic beverages. An agency document dated and signed by LPN E on 11/20/2021, titled “... SN Visit Note” indicated (L) lower leg wound (10.5 cm x 8.5 cm x 0.3 cm), wound bed black, gray, brown, and tan, with drainage that saturated old dressing, and additional (L) lower leg wounds (3.0 cm x 3.0 cm x 0.2 cm) – morphed into wound #1 (above), (0.0 cm x 0.0 cm x 0.0 cm), wound healed, new wound on left shin, (0.2 cm x 0.2 cm x [greater than] 200. After giving same ... patient’s BS 45, then 38, then 53, despite feeding the patient. Per [family member], given Glucagon [emergency medical treatment medication to treat very low blood sugar] at MD visit today ... Patient lethargic through most of SNV [SN visit] ... anxious, saying he/she could not breathe ... saying he/she was dying ....” The document failed to evidence the nurse assessed O2 sat or current BS. An agency document dated and signed by LPN H on 05/05/2021, titled “... SN Visit Note” stated “... Patient fearful, anxious; maintains that he/she is unable to breathe ... O2 Saturation ... 95% ... MD NOTIFICATION: INR OF 7.3 [a value higher than 3.5 increases the risk of bleeding problems] ... PT/CG [patient/caregiver] EDUCATION: Withhold warfarin [blood thinner] until further notice ... [physician’s office] calling in Vitamin K [aids in clotting blood to counteract the high INR level] ... to patient’s pharmacy ....” The record failed to evidence a nurse followed up to ensure the patient received the Vitamin K, re-checked the INR, or an RN performed a follow up assessment for this change in condition; and failed to evidence an RN attempted to make a visit at any time after LPN H’s visit on 05/05/2021. During an interview on 12/13/2021 at 2:15 PM, when queried if she would have expected an RN to follow up after the findings on 05/05/2021, clinical manager B stated “... Yes, definitely ....” An agency document dated and signed by administrator/RN A on 05/08/2021, titled “... Transferred to an Inpatient Facility ....” indicated the patient was admitted to the hospital on 05/08/2021, and stated “... Patient was admitted to hospital for dyspnea [difficulty breathing] ... Found to have Covid, Covid pneumonia, acute hypoxic respiratory failure [oxygen levels in blood so low that the body’s needs cannot be met, and unmanageable by oxygen supplementation] ....” 13. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis of cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses of pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, and bed confinement status. Record review evidenced a document dated and signed by RN I on 11/07/2021, titled “... Start of Care ....” This document indicated the patient with complex needs received SN services for wound care including NPWT (negative pressure wound therapy) (a vacuum sealed wound treatment device), IV antibiotic medication administration, and lab draws, and was ordered to be seen 4 times by the nurse during the first week on service. The record evidenced SNV #2 was made on 11/08/2021. An agency document dated 11/09/2021, (not signed) by RN I (visit #3 for the week), titled “... SN Visit Note” stated “... Wound vac to be changed tomorrow ... family is overwhelmed with her care ....” The record failed to evidence a visit was attempted or made on 11/10/2021 or 11/11/2021. An agency document dated and signed by RN I on 11/12/2021, titled “Missed Visit Note” stated “... There was no answer at door ... no answer via cell phone ....” During an interview on 12/13/2021 at 1:46 PM, when queried if the patient’s record evidenced any follow up for the missed visit on 11/12/2021, to determine the patient’s safety, clinical manager B stated “...No.” When queried if the agency had a policy to address a situation such as this, clinical manager B and regulatory and resource specialist both indicated they didn’t think there was. When queried if the record evidenced a nurse attempted to see the patient on 11/10/2021 or 11/11/2021, clinical manager B indicated there was not. An agency document dated 11/15/2021, titled “... Transferred to an Inpatient Facility ....” was initiated by RN I, but the document was incomplete, unsigned by the nurse, and failed to evidence the date or reason the patient was admitted. An agency document titled “Physician Supplemental Order” stated “... Order received ... 12/1/2021 ... Prior Hospitalization Stay ... 11/15/2021-11/30/2021 ....” This document was not signed by RN I or the ordering physician. A document received from hospital EE on 12/06/2021, dated 11/15/2021, titled “ED Triage Notes ....” stated “... C/C [chief complaint] fever of 105 [degrees], lethargic ....” A document received from hospital EE on 12/06/2021, dated 11/15/2021, titled “... Emergency Department Encounter” stated “... [diagnoses] included but not limited to: Sepsis [whole body system infection] secondary to bedsores, UTI, pneumonia, intra-abdominal infection ... admitted in serious but relatively stable condition ....” A document received from hospital EE on 12/06/2021, dated 11/16/2021, titled “History and Physical” stated “... [patient] has a chronic indwelling catheter ....” A document received from hospital EE on 12/06/2021, dated 11/30/2021, titled “Discharge Summary” stated “... discharged to home today with a very poor prognosis ...” 14. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, certification period 12/07/2021 – 02/04/2021, primary diagnosis of unstageable pressure ulcer, sacral (lower back) region, other pertinent diagnoses of unstageable pressure ulcer (L) buttock, cellulitis left lower extremity (LLE), unspecified dementia, and dependence on wheelchair. Record review evidenced a document dated and signed by RN G on 12/07/2021, titled “... Start of Care ....” This document indicated the patient received SN twice weekly for wound care, the patient had no pain, an unstageable pressure ulcer on the coccyx (tailbone area) which measured 6.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage (a white, yellow, or brown fluid, might be slightly thick in texture, a sign of infection), gray wound bed, with macerated skin around the wound (maceration occurs when skin has been exposed to moisture for too long, skin looks soggy, feels soft, or appears whiter than usual); and an unstageable pressure ulcer on the (L) buttock, which measured 5.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage, gray wound bed, and surrounding skin was erythemic (redness of the skin caused by congestion of the capillaries in the lower layers of the skin; occurs with any skin injury, infection, or inflammation). The document also evidenced calmoseptine was applied to both wounds, and FNP C was scheduled to see the patient 12/08/2021, for wound care orders. The section of the document titled “Additional Description/Comments for Integumentary [skin] Assessment” was blank and failed to evidence the nurse assessed the patient’s LLE for the documented diagnosis of cellulitis. An agency document received on 12/13/2021 at 11:20 AM, dated 11/09/2021, titled “... SN Visit Note”, indicated a skilled nursing visit was made by administrator/RN A on 11/09/2021, from 10:00 PM – 10:45 PM. The document was incomplete, and not signed by the RN. During an interview on 11/17/2021 at 10:42 AM, when queried what was the timeframe for clinicians to turn in documentation following a visit, administrator/RN A stated “... 24-48 hours ....” An agency document received on 12/13/2021 at 11:20 AM, dated and signed by administrator/RN A on 12/09/2021 at 3:23 PM, titled “Physician Supplemental Order” stated “... SKILLED NURSING ... Apply wound dressing ... clean ... with NS [normal saline] ... apply aquacel ag [absorptive dressing with silver as an antimicrobial] to wound bed, cover with mepilex [foam adhesive border dressing] ... Change 3x [times] a week and prn [as needed] ....” During an interview on 12/13/2021 at 11:15 AM, when queried if calmoseptine was an appropriate wound treatment for wounds described on the start of care visit, administrator/RN A stated “No, which is why we called to get another order ....” When queried if her nursing note was completed for the visit on 12/09/2021, administrator/RN stated “Nope, I’m not done with my note for 12/9/2021 ... Yes, the wound[s] got worse from the 7th to the 9th [12/07/2021 – 12/09/2021] ....” When queried what wound care she administered to the patient on 12/09/2021, administrator/RN A stated, “At that time, I just did the calmoseptine and adhesive dressing until I spoke to [FNP/family nurse practitioner C] to get orders ....” When queried if the agency started the new wound treatment orders received on 12/09/2021, administrator/RN A stated, “[The patient] was being seen today [12/13/2021], so today it will start ... this [12/13/2021] is the first visit after it was ordered ....” The record failed to evidence a nurse reassessed the patient on 12/10/2021, or 12/11/2021, after the visit frequency was increased to 3 times weekly, and the wound was identified as worse on 12/09/2021, by administrator/RN’s own admission. An agency document dated and signed by RN G on 11/13/2021, titled “... SN Visit Note” indicated the unstageable pressure ulcer on the coccyx (tailbone area) measured 5.6 cm x 3.8 cm x 1.0 cm, with thin, watery pale pink to red drainage, gray wound bed; and the unstageable pressure ulcer on the (L) buttock, which measured 4.8 cm x 4.0 cm x 1.0 cm, with thin, watery pale pink to red drainage, gray wound bed, and surrounding skin was intact, pain level was “3”, and stated “Pressure ulcer to coccyx and ischium [left buttock] improved this visit ... [patient] ... does state ‘ouch’ during cleansing of wound ....” The document failed to evidence the nurse assessed the patient’s BLE for known cellulitis. During an interview on 12/14/2021 at 11:51 AM, when queried when the surveyor could perform a home visit with an RN and patient #11, administrator/RN A indicated the patient’s family member said we cannot go see the patient until tomorrow (12/15/2021) since wound treatments were scheduled for Mondays, Wednesdays, and Fridays, and the family member was trying to get a wound clinic appointment for the patient. During this time, administrator/RN A then indicated she implemented the wound treatment ordered 12/09/2021, during her visit on 12/09/2021, she did not apply the calmoseptine, and stated “... Yes, I’m changing my answer ... I can’t remember what I do on everybody ....” Additionally, clinical manager A stated “... I guess I want you to look at [patient #11] again ... because if the note was done ... and you saw it ... it wouldn’t have been an issue ... I know we are going to do better ... my goal is to have you find something different on [patient #11] ....” A home visit was observed on 12/15/2021 at 10:06 AM, with administrator/RN A, RN G and surveyor P also present. Observation was made of a sheet of paper attached on the refrigerator which stated “... compression sock [socks that apply gentle pressure to your legs and ankles, promoting blood flow from your legs to your heart, and help control swelling] on (L) [left leg] ....”, observed patient lying on their left side in bed, with lower-calf length loose-fitting socks on both feet, both feet/lower legs slightly swollen, particularly along and above sock line, RN G removed socks, and LLE was red, dry, and scaly, with skin flaking off. RN G then removed the patient’s incontinence brief tab over the right hip, and exposed wounds which were not covered with dressings. During this time, RN G indicated ALF K knew she was coming, performed incontinence care and removed the dressings prior to our arrival. Six wounds were initially observed; there was a large unstageable pressure ulcer observed on the coccyx, greater in size than the diameter of a baseball (baseball = 7.3-7.5 cm), at least 1.0 cm deep, gray/black wound bed, and small amount of tan slough. Drainage could not be determined due to removal of old dressing; a full-thickness wound (damage extended below all layers of the skin) which bordered the lower part of the coccyx ulcer, located at approximately 7:00 o’clock, with a beefy red wound bed, extending diagonally down, approximately 5.0 -7.0 cm x 2.0 – 3.0 cm x 0.1 - 0.2 cm, unknown drainage; a wound on the (R) ischium, with undermining at the 12:00 o’clock position; the tissue, when lifted, was yellow slough, and the remaining wound bed was gray/black, size was approximately 3.0 – 4.0 cm in diameter, larger when undermining exposed, and depth at least 1.0 cm, unknown drainage; a full-thickness wound to the upper left of the (R) ischium wound, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep; a full-thickness wound to the lower left of the (L) ischium wound, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep, drainage unknown; a full-thickness wound below the (R) ischial wound on the upper/back thigh, just below the posterior buttock crease, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep, drainage unknown. The patient’s skin surrounding all wounds/buttocks area was erythemic. During wound care, RN G applied foam dressings with adhesive borders directly stuck on open wound beds, and indicated to administrator/RN A that she would talk to FNP C about a bigger dressing. During wound care, the patient yelled out in pain, flinched, grabbed at wounds, and yelled for the nurse to stop. After this wound care was completed, Surveyor P asked RN G to assess the patient’s back prior to turning them over. The patient’s back was exposed, and an unstageable wound was observed on the patient’s right lateral (side) trunk, mid- thoracic level (from shoulder level and downward to upper level of lower back), approximately 1.0 – 2.0 cm x 3.0 4.0 cm x 0.0 cm, the center of the wound was dark purple/black, surrounding skin erythemic; and a long dark red/purple line approximately 5-6 inches in length along the right-side waistline/crease with no open area. During this time, administrator/RN A indicated the patient always leaned to that side (right) when she was seated up in a chair. Both areas were left open to air (OTA). RN G and administrator/RN A turned patient over onto her right hip, and an additional wound was observed, which was approximately 5.0 cm x 10.0 cm x 0.0 cm, raised and swollen, boggy upon touch by RN G, dark purple with erythemic skin around wound, and an open area on the distal portion of this wound which was approximately 1.0 – 2.0 in diameter, approximately 0.1 -0.2 cm deep, with a red wound bed and white pinpoint size areas. During this visit, RN G did not measure any wounds with an actual measuring device. When asked, RN G indicated she had a ruler in her car; when asked how she determined wound depth, she indicated the wounds had no depth. When the patient was positioned onto their right side after all care was completed, the patient yelled out in pain as their leg was lifted to prop a blanket between their knees. A total of 9 wounds were identified during this home visit. During an interview on 12/15/2021 at 11:00 AM, (immediately after the home visit at ALF K), when asked if ALF K staff assessed patient wounds at this facility, administrator/RN A indicated she did not know. During this time, RN G indicated she just talked to ALF K staff to request a hospital bed and a special mattress. An agency document dated and signed by RN G on 11/15/2021, titled “... SN Visit Note” indicated the nurse documented only 6 wounds, identified the ischial (buttock) wound as located on the left side, when it was actually on the right ischium, documented the coccyx wound as 1.0 cm in depth, left buttock as 1.0 cm in depth, and all other wounds as < 0.1 cm in depth; documented the patient’s pain was a “4”, aching, and the patient had no pain medications ordered; and documented the patient had no new pressure ulcers identified this visit. An undated document received from ALF K on 12/17/2021, titled “Medication Record” indicated norco (narcotic pain medication) was ordered on 12/08/2021, to be given every 8 hours as needed for moderate to severe pain, and tylenol was ordered 12/08/2021, to be given every 6 hours as needed for mild pain. 15. During an interview on 11/19/2021 at 1:00 PM, when asked to describe the agency’s process for when an LPN found a new or worsening change in patient condition, administrator/RN A indicated she would inform the RN case manager, other team members, the physician, and write an order if needed. When asked if an RN should then go out and re-assess the patient after a reported new or worsening change, administrator/RN A indicated she didn’t think it was mandated that an RN had to go out and assess the patient. 16. During an interview on 11/30/2021 at 12:30 PM, when asked who assured the patients’ needs were continually assessed, clinical manager B indicated it was administrator/RN A’s responsibility, in conjunction with the RN case managers. 17. During an interview on 12/14/2021 at 11:14 AM, clinical manager B indicated the agency did have a lot of patients, their growth occurred within the last 60 days, (agency) would stop taking patients until they got this pulled together, she knew that the surveyor reviewed charts with patients that were hospitalized, but no one could be sure that it was their fault; she knew re-hospitalization rate in Indiana was 15% and (agency’s) is 19%, and when queried when the re-hospitalization data was obtained, clinical manager A stated “... like within the last 6 months, I think ... we cannot be there 24/7 ....” 17-14-1(a)(1)(B)

Within 48 hours of the patient's return CFR(s): 484.55(d)(2) Within 48 hours of the patient's return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This ELEMENT is not met as evidenced by: Based on record review and interview, the registered nurse (RN) failed to conduct a comprehensive assessment visit within 48 hours of a hospital discharge for 1 of 2 records reviewed for a patient who was hospitalized as an inpatient for 24 hours or more (#2). Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The initial assessment visit must be performed ... Within 48 hours of the patient’s return home from a 24-hour hospital admission ....” Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, evidenced a Hospital D document dated 10/12/2021. This document indicated the patient was hospitalized (inpatient status) on 10/04/2021, for nausea/vomiting due to tube feedings and hyponatremia most likely secondary to excessive free water flushes with tube feeds and was ordered NPO (take nothing orally/by mouth), and was discharged to home on 10/08/2021. An agency document dated and signed by RN I on 10/12/2021, titled “... Resumption of Care ....” (comprehensive assessment) evidenced assessment was completed greater than 48 hours after the patient was discharged to home. During an interview on 12/07/2021 at 1:54 PM, when queried why the resumption of care (comprehensive assessment) occurred 4 days after the patient was discharged from the hospital (discharge date of Friday, 12/08/2021), alternate clinical manager A stated, “ I don’t think we even knew she was home ....”, and indicated she faxed (hospital D) on Monday, 10/11/2021 for patient’s hospitalization records, received them on 10/12/2021, and office assistant D called the hospital every day to check status. During this time (2:49 PM) office assistant D indicated she didn’t call every day, and alternate clinical manager A indicated they didn’t check patient status on weekends. When asked why the comprehensive assessment dated 10/12/2021 indicated the physician ordered the resumption of care to occur on 10/12/2021, the clinical and alternate clinical managers both indicated they didn’t know. During an interview on 12/08/2021 at 11:00 AM, family verbally consented for surveyor to screen shot text messages between herself and RN I. Observation was made of a text message sent from family to RN I on 10/08/2021 at 1:24 PM, which stated “[patient] is going to be discharged around 3 [PM]”, a reply sent from RN I to family at 1:26 PM, stated “Sounds good. Please ask them to fax us a resume order ....”, an additional reply sent from RN I to family at 1:44 PM, stated “I can be out to see you Monday [10/11/2021] afternoon. Call me over the weekend if you have any questions ....”

Discharge Planning CFR(s): 484.58 Condition of Participation: Discharge planning. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to develop and implement an effective discharge planning process for the agency; failed to develop/maintain discharge/transfer summary policies which included discharge/transfer summary content, and procedure(s) to ensure the agency provided the receiving facility with necessary medical information (See G562); failed to ensure the agency sent discharge summaries with all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, and failed to ensure the agency sent a transfer summary when the patient was transferred to an acute care facility for emergent care which resulted in hospital admission (See G564). This practice had the potential to affect all agency patients. The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR §484.58: Discharge Planning.

Discharge Planning CFR(s): 484.58(a) Standard: Discharge planning. An HHA must develop and implement an effective discharge planning process. For patients who are transferred to another HHA or who are discharged to a SNF, IRF or LTCH, the HHA must assist patients and their caregivers in selecting a post-acute care provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The HHA must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to develop and implement an effective discharge planning process for the agency. Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Discharge Criteria and Process ....” stated “... A discharge summary will be completed and filed in the clinical record ... For a patient requiring continuing care, assistance will be given to the patient and family/caregiver in order to manage continuing care needs after ... services are discontinued ... Discharge instructions will be provided ... Arrangements for such services will be coordinated by the ... [agency] ... when applicable ... A discharge summary will be completed for all discharged patients. A copy may be mailed to the primary physician ... discharge paperwork ... will include ... discharge order, discharge summary, plan of care, medication profile, and OASIS [outcome and assessment information set] ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Discharge Planning ....” stated “... Information will be provided to assist the patient in planning ... discharge, including ... transfer ... Clinicians will assist patients regarding their discharge ... Sending a post discharge letter to the patient’s physician ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Discharge Summary ....” stated “... Purpose ... To define the requirements for documentation ... Each patient discharged ... will have a written discharge summary completed and filed in the clinical record ... discharge summary ... may include ... name of organization to which the patient is being transferred ... status of problems identified ... progress toward goals ... Medical status ... including continuing ... needs ... summary of the care or services provided ... A copy of the discharge summary will be provided to the patient’s physician when requested ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Transfer/Referral Criteria and Process ....” stated “... To outline the process for transferring or referring a patient to another service provider ... The physician ... will be notified and an order will be obtained to transfer the patient ... The physician ... who writes the patient transfer order will verbally confirm the transfer arrangements and give the appropriate information to the receiving health care provider ... All communication ... will be documented in the clinical record ... Within 72 hours of transfer, the clinical records clerk will send a copy of the transfer summary ... to the receiving provider ... a copy of the transfer summary will also be sent to the physician ....” A Centers for Medicare and Medicaid document revised 02/21/2020, titled “State Operations Manual ....” stated “... Contents of the clinical record ... Implementation: 09-28-18 ... 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 [home health agency] ... within 5 business days of the patient’s discharge; or ... 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 ... 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 ....” During an interview on 11/19/2021 at 1:00 PM, person A (corporate regulatory and resource specialist) submitted the agency’s discharge summary policy, and when queried about the transfer summary policy, she indicated the discharge summary was also the transfer summary policy, and it was pretty much the same thing. During an interview on 11/30/2021 at 12:30 PM, when queried how many days’ notice must be given to a patient prior to discharge, clinical manager B indicated she couldn’t recall, and stated “... I’ll say 5-7 days ....” When queried how the patients were notified of discharge, she indicated they received written notice. When queried where the discharge information was documented, she indicated it was in the clinical record, within the “camera” tab. When queried what other documentation and/or orders was required for the discharge process, she indicated a discharge OASIS was completed for every patient, a discharge order with reason for the discharge, and indicated she thought there was a clinical summary within the OASIS. During an interview on 12/13/2021 at 10:45 AM, when queried if the agency’s policies were updated to reflect the Centers for Medicare and Medicaid Services regulation updates in 2018 and 2020, clinical manager B indicated if they (policies) needed to be updated, then corporate quality updated it, and the date on the bottom (of the policies) represents the most recent update from CHAP. During this time, person A indicated they were bad about putting updated dates on policies, they were constantly updating the policies, it was ever changing, and they’d need a whole team and a lot of time to go over every policy at the same time.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure it sent discharge summaries with all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, and/or discharge orders for 1 of 1 records reviewed with discharge- not to an inpatient facility, (#3); and failed to ensure it sent a transfer summary to the receiving facility and/or physician for 5 of 5 records reviewed where the patient was transferred to an acute care facility for emergent care which resulted in hospital admission (#2, 7, 8, 9, 10). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Discharge Criteria and Process ....” stated “... A discharge summary will be completed and filed in the clinical record ... Discharge instructions will be provided ... A discharge summary will be completed for all discharged patients. A copy may be mailed to the primary physician ... discharge paperwork ... will include ... discharge order, discharge summary, plan of care, medication profile, and OASIS [outcome and assessment information set] ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Discharge Planning ....” stated “... Information will be provided to assist the patient in planning ... discharge, including ... transfer ... Clinicians will assist patients regarding their discharge ... Sending a post discharge letter to the patient’s physician ....” 3. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Discharge Summary ....” stated “... Purpose ... To define the requirements for documentation ... Each patient discharged ... will have a written discharge summary completed and filed in the clinical record ... discharge summary ... may include ... name of organization to which the patient is being transferred ... status of problems identified ... progress toward goals ... Medical status ... including continuing ... needs ... summary of the care or services provided ... A copy of the discharge summary will be provided to the patient’s physician when requested ....” 4. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Transfer/Referral Criteria and Process ....” stated “... To outline the process for transferring or referring a patient to another service provider ... The physician ... will be notified and an order will be obtained to transfer the patient ... The physician ... who writes the patient transfer order will verbally confirm the transfer arrangements and give the appropriate information to the receiving health care provider ... All communication ... will be documented in the clinical record ... Within 72 hours of transfer, the clinical records clerk will send a copy of the transfer summary ... to the receiving provider ... a copy of the transfer summary will also be sent to the physician ....” 5. A Centers for Medicare and Medicaid document revised 02/21/2020, titled “State Operations Manual ....” stated “... Contents of the clinical record ... Implementation: 09-28-18 ... 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 [home health agency] ... within 5 business days of the patient’s discharge; or ... 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 ... 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 ....” 6. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021. Record review evidenced twice during the certification period, the patient received emergent care that resulted in hospital admission. The record failed to evidence transfer summaries were sent to the receiving facility, or to the patient’s physician(s). A document dated and signed by administrator/RN (registered nurse) A on 10/4/2021 at 9:11 PM, titled “Physician Supplemental Order”, stated “... Status Report with Comments and Notes ... Hold all home health services as the patient was admitted to the hospital ... May discharge the patient from the agency if does [sic] not return by [end of certification period] ....” The document failed to evidence which hospital the patient was transferred to, or the patient was transferred for emergent care. A document dated and signed by administrator/RN A on 10/04/2021 at 9:11 PM titled “... Transferred to an Inpatient Facility-Patient not discharged from agency ....” evidenced the patient was transferred to hospital D on 10/04/2021. A document dated and signed by administrator/RN A on 10/22/2021 at 9:08 PM, titled “... Transferred to an Inpatient Facility-Patient not discharged from agency ....” evidenced the patient was transferred to hospital D on 10/22/2021. During an interview on 12/07/2021 at 1:54 PM, when queried to describe the transfer process, administrator/RN A indicated the transfer OASIS was completed when the agency was made aware, office assistant D called the hospital to let them know why they were admitted, find out if they were admission or observation, let them know we were their home care, and send a transfer summary and medication list. When queried if there was documentation for the sent transfer summaries, administrator/RN A indicated she had no idea. When queried if there were any other requirements for the transfer process, administrator/RN A indicated she didn’t think so. During this time, clinical manager B indicated she didn’t really want to discuss every item, or “we’ll be here forever”. 7. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, evidenced a document dated 09/24/2021, signed by physical therapist (PT) J on 09/28/2021 at 8:07 PM, titled “... Discharge from Agency- Not to an Inpatient Facility ....” which evidenced a box checked which indicated a discharge summary was sent to the physician on 09/28/2021, but the record failed to evidence a discharge summary document. 8. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, for certification period 10/30/2021 – 12/28/2021. Record Review evidenced a document dated and signed by licensed practical nurse (LPN) E on 11/03/2021, titled “... SN Visit Note” which indicated the patient resided at an assisted living facility (ALF), and stated “... MD [medical doctor] notified by ED [executive director (of ALF)] and he ordered for the patient to be sent to the ED [emergency department] ... transferred by a private ambulance ... to [hospital D] ....” The record failed to evidence a transfer summary was sent to the receiving facility, or to the patient’s physician. A document dated and signed by administrator/RN A on 11/03/2021, titled “Physician Supplemental Order”, stated “... Status Report with Comments and Notes ... Hold all home health services as the patient was admitted to the hospital ... May discharge the patient if she does not return by [end of certification period] ....” The document failed to evidence which hospital the patient was transferred to, or the patient was transferred for emergent care. A document dated and signed by LPN E on 11/26/2021, titled “Missed Visit Note” stated “... Patient Hospitalized ... Patient taken by ambulance to [hospital E] just prior to this author’s arrival ....” The document evidenced the agency and administrator/RN A was notified on 11/27/2021, and the ALF notified the physician on 11/27/2021. A document dated and signed by administrator/RN A on 11/26/2021 at 8:11 PM, titled “Physician Supplemental Order”, stated “... Status Report with Comments and Notes ... Hold all home health services as the patient was admitted to the hospital ... May discharge the patient from the agency if she does not return by [end of certification period] ....” The document failed to evidence which hospital the patient was transferred to, or the patient was transferred for emergent care. The record failed to evidence a transfer summary was sent to the receiving facility, or to the patient’s physician. 9. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, evidenced a document dated and signed by administrator/RN A on 07/20/2021, titled “Physician Supplemental Order”, which stated, “... Status Report with Comments and Notes ... Hold all home health services as he was admitted to the hospital ... May discharge the patient from the agency if he does not return by [end of certification period] ....” The document failed to evidence which hospital the patient was transferred to, why the patient was transferred, or if the patient was transferred for emergent care. The record failed to evidence a transfer summary was sent to the receiving facility, or to the patient’s physician. A document dated and signed by administrator/RN A on 07/20/2021, titled “... Transferred to an Inpatient Facility-Patient not discharged from agency ....” evidenced the patient was transferred to hospital FF on 10/22/2021. The record also failed to evidence the agency verified the if the patient remained hospitalized at the end of the certification period. During an interview on 12/13/2021 at 2:36 PM, when queried if a transfer summary was sent, clinical manager B indicated it was not. 10. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, evidenced a document dated and signed by administrator/RN A on 05/08/2021, titled “Physician Supplemental Order”, which stated, “... Status Report with Comments and Notes ... Hold all home health services as the patient was admitted to the hospital ... May discharge the patient from the agency if she does not return by [end of certification period] ....” The document failed to evidence which hospital the patient was transferred to, why the patient was transferred, or if the patient was transferred for emergent care. The record failed to evidence a transfer summary. A document dated and signed by administrator/RN A on 05/08/2021, titled “... Transferred to an Inpatient Facility-Patient not discharged from agency ....” evidenced the patient was transferred to hospital OO on 05/08/2021. A document dated and signed by administrator/RN A on 05/13/2021, titled “Case Conference and Care Coordination” evidenced the patient was transferring from hospital OO to skilled nursing facility (SNF) PP (prior to the end of the certification period), and failed to evidence the physician was notified. During an interview on 12/13/2021 at 2:15 PM, when queried if the record included a transfer summary, clinical manager B indicated it did not. 11. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, evidenced a document dated and signed by RN I on 11/12/2021 titled “Missed Visit Note”, which stated, “... Arrived to patients [sic] new residence for a scheduled appointment at appropriate time. There was no answer at the door buzzer and no answer via cell phone ....” During an interview on 12/13/2021 at 1:46 PM, when queried if any actions were taken to determine the patient’s safety, clinical manager B indicated there was not. When queried if the agency had a policy for situations such as this, to ensure the patient’s safety and wellbeing, Person A (corporate regulatory and resource specialist) and clinical manager B both indicated they did not. The record failed to evidence any communication between the agency and the patient and/or family occurred until after the patient was discharged to home from the hospital on 11/30/2021. A document received from hospital EE on 12/06/2021 evidenced the patient was hospitalized for emergent care from 11/15/2021 – 11/30/2021. A document dated 11/15/2021, titled “... Transferred to an Inpatient Facility-Patient not discharged from agency ....” was initiated, but not completed or authenticated/electronically signed by RN I as of 12/09/2021. The record failed to evidence an order was obtained for the transfer, a transfer summary, or a summary was sent to the physician. During an interview on 12/13/2021 at 2:16 PM, when queried where the patient was transferred to, clinical manager B indicated she didn’t know, and the transfer document was incomplete. When queried if a transfer summary was sent to the receiving facility, she stated “No.” When queried what documents were normally sent when a patient was transferred, clinical manager B indicated the transfer documents were transfer the actual transfer OASIS and the medication list, it would get faxed to the facility, and the agency had no specific form. When queried about the discharge summary process, clinical manager B indicated they had a discharge summary that was completed on the discharge OASIS, she thought they sent them to the physician upon request, and they sent a discharge order with the reason for discharge. Upon exit, no additional documents were submitted.

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: An immediate jeopardy (IJ) related to Care Planning, Coordination of Services, and Quality of Care was identified on 12/06/2021. The administrator was notified on 12/06/2021 at 1:13 PM. The immediate jeopardy remained unabated upon the survey exit on 12/17/2021, due to an additional record review for patient #11 on 12/13/2021, 12/15/2021, and completed on 12/17/2021; and findings observed during a home visit with patient #11 on 12/15/2021. This home visit was conducted for a newly admitted patient (start of care 12/7/2021), with a primary diagnosis unstageable pressure ulcer of sacral (lower back) region, and other pertinent diagnoses of unstageable pressure ulcer of left buttock, and cellulitis of left lower limb, who received skilled nursing services for wound care. This record review and home visit failed to evidence effective care coordination between agency, FNP(family nurse practitioner) C and ALF (assisted living facility) K to meet the patient’s needs; failed to evidence the patient’s plan of care was accurate, individualized, included patient-specific nursing interventions and frequencies to meet the patient’s needs, which resulted in the patient’s development of 7 new and 2 worsening wounds after the start of care, wound infection which required oral antibiotic treatment, and inadequate pain control. Additionally, by the agency’s own admission, it failed to ensure all disciplines including contracted staff was re-educated on care planning, coordination of care, and interdisciplinary communication. Additionally, the agency failed to ensure all patients received the home health services that were written in the plan of care, and/or ensured the patient’s plan of care was individualized (See G572); failed to ensure the patient’s plan of care included all pertinent diagnoses, the patient’s psychosocial, and/or cognitive status, supplies and equipment needed, prognosis, functional limitations, activities permitted, nutritional requirements, all medications and/or treatments, safety measures to protect against injury, interventions to address underlying risk factors for emergency department visits and hospital re-admission(s), patient and/or caregiver education and training, and/or patient-specific interventions and education (See G574); failed to ensure the clinician promptly notified the patient’s physician or FNP for a significant change in the patient’s physical and/or psychosocial condition (See G590); and failed to ensure all patients received written information of the name and contact information of the clinical manager (See G622). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.60: Care Planning, Coordination of Services, and Quality of Care. 17-13-1(a) 17-13-1(a)(2) 17-13-1(a)(1)(B) 17-13-1(a)(1)(C ) 17-13-1(a)(1)(D)(ii, iv, vi, vii, viii, ix, x, xiii) Based on observation, record review and interview, the home health agency failed to ensure all patients had individualized plans of care, the plans of care were implemented as ordered by the physician, or communication/care coordination occurred between all disciplines including employees and contracted staff. This resulted in new and/or worsening symptoms, wounds, infections, aspiration pneumonia and multiple potentially avoidable hospitalizations. This practice had the potential to affect all agency patients. Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Monitoring Patient’s Response/Reporting to Physician” stated “... Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient ... The patient’s physician will be contacted on the same day when any of the following occur: ... Significant changes in the patient’s condition ... When able to contact the patient’s physician ... Clinical Supervisor will notify the organization’s Medical Director ... to request medical consultation ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Medication Monitoring” stated “... Ongoing patient medication monitoring will use a collaborative approach between clinicians, physicians ....” 3. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Care/Service Coordination” stated “... Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and ability of the patient ....” 4. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Care Planning Process” stated “... The care planning process will be documented on the plan of care ... includes ... Nutritional requirements ... Medications and treatments ... develop the patient plan of care based on ... Individualized patient needs ... Clinical drug monitoring ... Pain and symptom management ... will be revised as frequently as deemed necessary ... Revision dates will be noted on the plan of care ... will be based on changes in the patient’s health status, needs, and the environmental factors affecting care ... Services to be provided will be based on the prioritized needs of the patient ....” 5. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Pain Assessment” stated “... When the patient or the clinician identifies pain the following in-depth pain assessment information should be obtained ... Present pain management and effectiveness ... Pain management history to include a medication history ... barriers to reporting pain and using analgesics, past intervention and response, and manner of expressing pain ... The patient’s pain goal, including pain intensity and goals related to function, activities, and quality of life ....” 6. A Johns Hopkins web-based reference, https://www.hopkinsmedicine.org/gec/series/wound_care.html, reviewed on 12/15/2021, titled “Wound and Pressure Ulcer Management”, stated “... [pressure ulcer] ... Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough (yellow, tan, gray, green or brown) and/or eschar (tan, brown or black) in the wound bed ... Measurement ... Length – from top edge to the bottom edge (head to toe) at longest point ... Width – from edge to edge perpendicular to the length at widest point ... Depth – straight in, perpendicular to the base, at deepest point ... Necrosis/Eschar - Black, brown or tan devitalized tissue that adheres to the wound bed or edges and may be firmer or softer than the surrounding skin ... Slough - Soft, moist avascular tissue that adheres to the wound bed in strings or thick clumps; may be white, yellow, tan or green ....” 7. A Drugs.com web-based reference, https://www.drugs.com/cdi/calmoseptine.html, reviewed on 12/15/2021, stated “... Calmoseptine ... It is used to protect skin from wetness, urine, or stools ... to treat diaper rash ... to treat minor cuts, scrapes, or burns ... Do not put on open or deep wounds ... infections ....” 8. A Centers for Disease Control and Prevention web-based reference, https://www.cdc.gov/groupastrep/diseases-public/Cellulitis.html, reviewed on 12/15/2021, stated “... Cellulitis is a common bacterial skin infection that causes redness, swelling, and pain in the infected area of the skin. If untreated, it can spread and cause serious health problems. Good wound care and hygiene are important for preventing cellulitis ....” 9. Record review for patient #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer (wound caused by unrelieved pressure, no deeper than all layers of the skin, and includes intact or ruptured blisters) of left buttock, and other pertinent diagnosis stage 2 pressure ulcer of right buttock, evidenced a comprehensive assessment dated and signed by RN (registered nurse) G on 10/29/2021, titled “... Recertification ....”, which evidenced the patient resided at ALF (assisted living facility) Q (based on documented address), was at risk for development of pressure sores, had a stage 2 pressure sore on the right (R) buttock, a "healed" pressure sore to the left (L) buttock, was incontinent of bowel and bladder, and she was disoriented (temporary or permanent state of confusion). A document dated and signed by RN G on 10/29/2021 titled “Home Health Certification and Plan of Care” for certification period 11/02/2021 – 12/31/2021 evidenced nursing interventions for wound care 2 times weekly, may culture wound as needed, evaluate patient’s response to plan of care (patient was disoriented); and failed to evidence the plan of care was individualized and included who the patient’s primary caregiver was for skilled teaching interventions and wound care when agency was not present, interventions to teach signs/symptoms of infection and when to report to agency and/or physician, prevention of new or worsening skin breakdown, or incontinence care. A document dated and signed by licensed practical nurse (LPN) H on 11/02/2021, titled “... SN [skilled nurse] Visit Note” evidenced the (R) buttock wound was scabbed, the (L) buttock wound bed was now gray, and failed to evidence LPN H notified the physician or clinical manager. A document dated and signed by LPN H on 11/9/2021, titled “... SN Visit Note” evidenced the (R) buttock wound was healed, the (L) buttock wound bed was then black, and was greater in size from previous visit, the patient complained of pain with sitting and during wound care, and failed to evidence LPN H notified the physician or clinical manager. A document dated and signed on 11/11/2021 by clinical manager B titled “LPN Sup [supervisory] Visit” evidenced the plan of care was reviewed, treatment approach was not modified, LPN H was not observed performing care, and stated “Patient is satisfied with [LPN H] ....”, but failed to evidence coordination occurred between LPN H and clinical manager B for update on deterioration of wound status. During an interview on 11/30/2021 at 1:30 PM, when asked how she performed the supervisory visit, clinical manager B indicated she did not make the supervisory visit at the patient’s home, she thought a supervisory visit was due, she made a call to the facility, she did not speak with the patient, and she was not sure what the patient’s orientation status was. A document dated and signed by LPN H on 11/15/2021, titled “... SN Visit Note” evidenced the (L) buttock wound bed was black, greater in depth from last visit, 0.2 cm depth undermining, strong odor, profuse bloody drainage, and the patient complained of pain with wound care. A document dated and signed by administrator/RN A on 11/15/2021 titled “Physician Supplemental Order” evidenced new antibiotics were ordered for 10 days (last dose 11/23/2021). A document dated and signed by LPN H on 11/17/2021 titled “Patient Infection Report” evidenced the date of onset for infection to the (L) buttock wound was 11/12/2021, antibiotics were ordered, and antibiotic treatment frequency ended on 11/23/2021. A document dated and signed by LPN H on 11/18/2021, titled “... SN Visit Note” evidenced the (L) buttock wound bed was black, greater in depth from last visit, 0.2 cm depth undermining, “less” drainage, now able to visualize “deeper tissue”, the patient complained of pain with wound care, cried out “Stop it” during wound care, patient was difficult to rouse during visit, and failed to evidence the clinical manager was notified. A home visit occurred on 11/18/2021 at 9:00 AM with LPN H present. The (L) buttock (ischium- the lower and back part of the hip bone) wound bed was black/gray, a small area of potential white bone/connective tissue was exposed, diameter of the wound was >/= (greater than or equal to) the diameter of a quarter (2.5 cm), the depth was approximately >/= the diameter of a quarter, there was undermining present at the top of the wound, a large amount of thick, creamy drainage was present, and the patient yelled out in pain during wound care. During this time, LPN H indicated administrator/RN A was the RN case manager, the wound wasn’t doing any better, and the wound appeared more necrotic (dead, black tissue) than before. During an interview on 11/30/2021 at 1:30 PM, when asked, clinical manager B indicated she would expect care coordination with the agency RN supervisor for signs and symptoms of infection, and new or worsening wounds. When asked if she would expect the wound to be cultured if infection was suspected, clinical manager B indicated if it was under the order of a physician, it should be cultured. When asked if the wound was cultured, she indicated she didn’t know, and didn’t see anything in the record. 10. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, primary diagnosis dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) on 9/21/2021, encounter for attention to gastrostomy (g tube), atherosclerotic heart disease (hardening of the arteries), hypertensive chronic kidney disease (high blood pressure caused by the narrowing of your arteries that carry blood to your kidneys), end stage renal disease (kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life), dependence on dialysis, and history of old myocardial infarction (heart attack) and coronary angioplasty (a medical procedure in which a balloon is used to open a blockage in an artery in the heart); and certification period 11/23/2021 – 1/21/2021, primary diagnosis pressure ulcer of sacral (lower back) region on 11/02/2021, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) added on 11/02/2021, dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) added on 11/02/2021, and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) added on 10/12/2021. A document dated and signed by RN I on 9/24/2021 titled “... Start of Care ... [initial comprehensive assessment] ....” evidenced the patient was dependent on dialysis every Monday, Wednesday and Friday, unintentional weight loss of 10 pounds or more in the last 12 months, history of falls, 2 or more hospitalizations in the past 6 months, aspiration precautions (ingestion of foreign objects, food or fluids into the lungs), experienced dizziness, reported pain, very poor nutrition, risk for skin breakdown, g tube placement on 9/21/2021, high blood pressure, pitting edema (dent left in extremity when pressed with finger due to fluid retention), able to take in nutrients orally, received supplemental tube feedings, received some medications via g tube, was on a renal diet (low in sodium, phosphorous, and protein, and also emphasizes the importance of consuming high-quality protein, and usually limiting fluids) with 1500 ml (milliliter) fluid restriction, received 8 ounces of Nepro (supplemental feeding) via g tube QID (4 times daily), and had a right upper arm fistula (venous access for dialysis). The document failed to evidence coordination with the dialysis center or physician. A document dated and signed by RN I on 09/24/2021 titled “Home Health Certification and Plan of Care” for certification period 09/24/2021 – 11/22/2021 failed to evidence where and when the patient attended dialysis, presence of the right arm fistula, who assessed/cared for the fistula, which medications were administered via g tube, how to administer medications and supplemental feedings via g tube, how much water to administer before and after administration, instruction of to remain in upright position for at least 30 minutes after food fluid intake to decrease risk of aspiration, methods to prevent skin breakdown, cardiovascular disease management, and dietary teaching. The document dated and signed by RN I on 9/30/2021 titled “... SN Visit Note” also evidenced the patient complained of nausea/vomiting, and failed to evidence the nurse notified the clinical supervisor or physician. Hospital D documentation dated 10/12/2021 evidenced the patient was hospitalized on 10/04/2021 for nausea/vomiting due to tube feedings and hyponatremia most likely secondary to excessive free water flushes with tube feeds and was ordered NPO (take nothing orally/by mouth), and was discharged to home on 10/08/2021. During an interview on 12/07/2021 at 1:54 PM, when asked why the resumption of care (comprehensive assessment) occurred 4 days after the patient was discharged from the hospital on Friday, 12/08/2021, administrator/RN A stated, “ I don’t think we even knew she was home ....”, and indicated she faxed (hospital D) on Monday, 10/11/2021 for patient’s hospitalization records, received them on 10/12/2021, and office assistant D called the hospital every day to check status. During this time (2:49 PM) office assistant D indicated she didn’t call every day, and administrator/RN A indicated they didn’t check patient status on weekends. When asked why the comprehensive assessment dated 10/12/2021 indicated the physician ordered the resumption of care to occur on 10/12/2021, clinical manager B and administrator/RN A both indicated they didn’t know. During an interview on 12/08/2021 at 11:00 AM, family verbally consented for surveyor to screen shot text messages between herself and RN I, a text message was sent from family to RN I on 10/08/2021 at 1:24 PM which stated “[patient] is going to be discharged around 3 [PM]”, a text reply sent from RN I to family at 1:26 PM stated “Sounds good. Please ask them to fax us a resume order ....”, and a text sent from RN I to family at 1:44 PM which stated “I can be out to see you Monday [10/11/2021] afternoon. Call me over the weekend if you have any questions ....”, and indicated she did not refuse a nursing visit for the patient on 10/14/2021. A document dated and signed by RN I on 10/12/2021 titled “... Resumption of Care [ROC] ....” (comprehensive assessment) evidenced the physician ordered the resumption of care to be completed on 10/12/2021, the nurse assessed crackles in the patient’s lower lungs (the small air sacs in the lungs fill with fluid), she had shallow breathing; and failed to evidence the nurse notified the clinical manager or physician for assessed findings, review, and approval of the revised plan of care. A document dated and signed by RN I on 10/14/2021 titled “Missed visit Note” evidenced the family requested cancellation of nursing visit same date due to multiple other agency disciplines’ visits scheduled for same day, and the patient had dialysis on 10/15/2021. The document failed to evidence a visit was offered for another day of that work week. A document dated and signed by RN I on 10/19/2021, visit time 12:30 PM – 1:30 PM, titled “... SN Visit Note”, evidenced the patient did not go to dialysis this date due to fatigue, nurse assessed “significant decline in respiratory status”, “ patient’s respiratory status declining”, nurse requested for family to transport to ED (emergency department), but family indicated she would take the patient to urgent care. During an interview on 12/08/2021 at 9:55 AM at dialysis center F, an untitled dialysis calendar was submitted by facility staff G, which evidenced the patient was not scheduled for dialysis on 10/19/2021. A document dated and signed by occupational therapist (OT) K on 10/19/2021, visit time 1:35 PM – 2:20 PM, titled “... OT Eval and CP [care plan]” evidenced the patient’s respirations were regular, the patient was stable, and failed to evidence the patient exhibited any respiratory complications. A document dated and signed by RN I on 10/22/2021 titled “... SN Visit Note” evidenced a nursing visit was made from 12:30 PM – 1:00 PM, the patient was on a general/regular diet, had supplemental g tube feedings, and failed to evidence the patient was on a 1500 ml fluid restriction. The document also evidenced the patient had increased weakness, nausea and vomiting, shortness of breath with onset of productive cough with copious amounts of mucus, and family was going to take the patient to urgent care. During an interview on 12/08/2021 at 12:52 PM, urgent care H staff I indicated the patient was checked in at the facility on 10/22/2021 at 1:07 PM, and was sent to the ED at 1:35 PM. During an interview on 12/08/2021 at 11:00 AM, family indicated RN I did not make a nursing visit on 10/22/2021, no one was there that day from the agency, a text message from RN I on 10/21/2021 at 2:44 PM was observed, which stated “ ... I’ll see you guys next week”, a text message on 10/22/2021 at 9:14 AM from family to RN I stated, “Rough morning as soon as the food hit her stomach she started vomiting ....”, a text message from RN I to family at 11:45 AM stated, “Were you able to get in touch with md [sic]?” and a text message from family to RN I at 2:09 PM stated “At the ER [emergency room] doctor said her lungs are horrible ....” A hospital D document titled “History and Physical Reports” evidenced the patient was admitted 10/22/2021, discharged on 10/31/2021. Hospital paperwork indicated family needed to be taught how to do tube feeds properly and prevent any further aspiration. A document dated and signed by RN I on 11/02/2021 titled “... Resumption of Care ....” failed to evidence the nurse notified the clinical manager or physician for assessed findings, review, and approval of the revised plan of care. A document dated and signed by RN I on 11/09/2021 titled “... SN Visit Note” evidenced the nurse assessed crackles in bilateral bases, continued with nausea/vomiting, and stated “... MD is aware of nausea as [family] called awaiting return call ....” The document failed to evidence the nurse notified the physician of assessed crackles in bilateral bases, or ongoing nausea/vomiting. A text message was sent from family to RN I on 11/10/2021 at 8:38 AM which stated “Well we are back to square one. She woke me up at 5am gave her 2 oz [ounces] formula tylenol [sic] and her new nausea medicine it no more hit her stomach and she vomited it all up. She is coughing a lot and doesn’t want to go to dialysis.”, a text from RN I to family at 8:50 AM which stated “... I just want her comfortable and it kills me we can’t help her”, and additional texts that indicated the patient didn’t want to go to the ED, the nurse indicated family could ask for a suppository for the nausea, asked family if the patient was still having rib cage and back pain, and failed to evidence the nurse asked to make a home visit to assess the patient. On Thursday, 11/11/2021 at 8:00 AM, family texted RN I to inform her the patient was at the ED (hospital D), and she returned home the same day with new medication orders. On Wednesday, 11/17/2021 at 12:25 PM, RN I texted family and stated “So there is a [sic] Indiana state surveyor here doing a survey for At Home Quality Care ... You do not have to say yes it’s your choice”, a text from family to RN I at 12:30 PM which stated, “Yes that [sic] fine”, and a text from RN I to family at 12:32 PM from RN I to family at 12:32 PM which stated “Do you care if I stop over today just to look at the [home] folder? I have to make sure the medication sheets and plan of care are n [sic] there and ... vital signs so we pass the survey ....” The clinical record failed to evidence the RN made another home visit after 11/09/2021 until 11/18/2021. A home visit observation occurred on 11/18/2021 at 12:55 PM with RN I present. This was a recertification comprehensive assessment visit. The patient presented seated upright in a living room chair, was coughing uncontrollably, tears streamed down her face, and family indicated she just had some sips of hot cocoa. During this time, RN I assessed crackles in bilateral lung bases, and indicated she would refer SLP (speech language pathologist), assessed an open area on the patient’s coccyx, and indicated she would notify the physician and get an order for mepilex (foam dressing), and she would stop by the patient’s home tomorrow (11/19/2021) to drop off wound supplies. A document dated and signed by RN I on 11/18/2021 titled “... Recertification ....” stated “... Patient previously has a stage II [2] pressure ulcer to coccyx; now unstageable due to 100% slough covering the wound bed ... notified [physician R] office ... detailed message left for [physician R’s nurse] ... requested orders and [patient] status report ....” The record failed to evidence an order was received. During an interview on 12/1/2021 at 1:35 PM, family indicated she informed the registered nurse on 11/21/2021 that the patient's blood pressure was “running high”, the nurse did not make a visit to assess the patient, the nurse texted to check on the patient's blood pressure on 11/22/2021, during which time family indicated she didn't write her blood pressure readings down, indicated to the nurse "something has changed, we took a big step backwards", the nurse did not make a home visit to assess the patient, and the patient was subsequently seen in the ED, hospitalized 11/24/2021- 11/25/2021 for hypertension and NSTEMI (a type of heart attack involving partial blockage of one of the coronary arteries) with stent placement. At that time, the nurse texted back to have family let her know when the patient got home. On 11/27/2021, family texted the nurse to inform patient was home from hospital, and the nurse replied to let her know when she'd like a visit, but did not offer to visit on that date. When asked if she would have accepted a visit from the nurse if she offered to come on 11/27/2021, family said "Of course". As of 12/1/2021, the patient was not seen by the nurse or SLP. The record failed to evidence the nurse notified the clinical supervisor or physician. During an interview on 12/3/2021 at 12:42 PM, when queried if the agency “front loaded” nursing visits (an increased nursing frequency of weekly visits based on patients who had complex and/or high-risk needs), clinical manager B stated “Yes ....”, and indicated it was based on diagnosis, high- tech needs such as IV (intravenous) treatment, wound vac (complex negative pressure wound therapy), or CHF (congestive heart failure). When queried if g tube patients were front loaded, clinical manager B indicated it would depend on if the patient/family already knew how to care for it. When queried if a patient would be front loaded for a new g tube, such as 3 days old, clinical manager B stated “Yes, definitely.” During an interview on 12/07/2021 at 10:50 AM, as a result of the immediate jeopardy (IJ) announced on 12/06/2021, clinical manager B indicated she wanted to discuss patient #2, and asked administrator/RN A to “take over the conversation”, as she knew the patient better. administrator/RN A did not respond, and when asked again by clinical manager B, administrator/RN A did not respond. Clinical manager B then indicated that when she previously indicated the patient should have been front loaded, she thought it was important to note the patient went to dialysis 3 times per week. Administrator/RN A then indicated family said she didn’t want the patient to be seen over the holiday weekend (11/25/2021 -11/28/2021), and the patient was non-compliant with attending dialysis. When queried why the patient was non-compliant, she indicated she didn’t know. The clinical record failed to evidence the nurse attempted to schedule a visit 11/25/2021 – 11/28/2021, evidenced the patient/family declined a visit during same timeframe, or evidenced the physician was notified of the patient’s non-compliance with dialysis. During an interview on 12/08/2021 at 9:55 AM at dialysis center F, facility staff G indicated the patient was compliant with receiving dialysis treatments, the only contact they had from At Home Quality Care were faxed documents for the physician to sign, other than a nurse called yesterday (12/07/2021), she believed that was the first call from the agency, and there was never any communications with the agency about the patient’s medications. 11. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow) and dependence on supplemental oxygen, evidenced a comprehensive assessment dated and signed by RN G on 10/26/2021, titled “... Recertification ....” This document evidenced 2 wounds: a stasis ulcer (L) leg, black wound bed, no odor; and an open wound (L) leg, pale pink wound bed, small amount serosanguinous drainage, no evidence of infection documented, assisted living facility (ALF) L was not permitted to perform wound care, pain rated by patient as “8” in (L) leg, and stated “... numeric [pain] scale ... 0: None ... 7-9: requires MD [physician] intervention ....” The document failed to evidence the physician was notified. A document dated and signed by RN G on 10/26/2021 titled “Home Health Certification and Plan of Care” for certification period 10/30/2021 – 12/28/2021 failed to evidence contact information for ALF L, primary caregiver to address wound care on days when agency not present, interventions to mitigate pain, teaching on prevention of new or worsening skin breakdown, or signs/symptoms of infection. A document dated and signed by LPN E on 11/01/2021 titled “... SN Visit Note” evidenced the (L) leg stasis ulcer and (L) leg open wound morphed into one larger wound, (L) leg calf edema (swelling), which measured 14 inches diameter, skin was shiny and pale around the wound; and an open wound to shin continued, and failed to evidence an order for treatment to the shin. A document dated and signed by LPN E on 11/03/2021 titled “... SN Visit Note” evidenced the calf edema increased to 15 inches diameter, the (L) leg dressing was saturated with drainage, the wound declined, patient had increased pain, was sent to ED for evaluation. This document also evidenced the patient was consuming 4-5 beers per day, and failed to evidence the physician was made aware. A hospital D document dated 11/04/2021 titled “History and Physical Reports” evidenced the patient was admitted on 11/03/2021 discharged on 11/08/2021, evidenced the patient complained of increased pain, redness and swelling to (L) lower leg, which spread up back of leg, for 2 days; and was admitted with cellulitis which required treatment with intravenous (IV) antibiotics. The document also evidenced the patient was a current daily beer drinker. A hospital D document dated 11/08/2021 titled “Discharge Documentation” evidenced the patient’s new medications included Levaquin (antibiotic) orally for 7 days, and tramadol (pain medication) every 6 hours as needed for pain. A document dated and signed by administrator/RN A on 11/09/2021 titled “... Resumption of Care ....” evidenced no wound orders were sent home with the patient from hospital D, she was unable to obtain orders, so she covered the wounds with dry gauze and wrapped the wounds with gauze rolls, and the patient had an appointment at wound clinic M on 11/11/2021. Additionally, the patient’s stated pain was “7”, (L) lower leg wound, wound bed brown, with drainage that saturated old dressing, and additional (L) lower leg wounds, wound bed pale pink, and, no wound bed description, both had drainage; went to a wound clinic weekly, and stated “... Patient has been found with a lot of beer in her room and has become a concern to facility ....” The document failed to evidence the nurse assessed how much beer the patient regularly consumed or a comprehensive assessment of the patient’s pain. The document failed to evidence the nurse notified the physician of findings during the visit. A document dated 11/9/2021 and signed by administrator/RN A on 11/11/2021 titled Physician Supplemental Order ....” failed to evidence alcohol abuse was identified during nursing visits. A document dated and signed by LPN E on 11/10/2021 titled “... SN Visit Note” evidenced (L) lower leg wound, wound bed now black, with drainage that saturated old dressing, and additional (L) lower leg wounds, one wound bed now gray, and another wound bed gray, both had drainage, patient rated pain at “8”, and stated “... Called wound clinic and patient was given an appointment for 11/11 [2021] as wounds need attention and orders ... Patient is peeling the skin ... precautioned on scratching with hangers and other objects as she has done in the past ... wounds 1 and 2 have increased and wound bed does not present with any viable [living] tissue ... Wound burned and hurt while cleansing ... No wound care orders ... covered with gauze and taped in place ... Patient stated she is ready to just have her leg cut off ... complained about being weak and tiring out very quickly ....”. The document evidenced the agency RN supervisor was informed, but failed to evidence the certifying physician was notified. A document dated and signed by administrator/RN A on 11/11/2021at 8:44 PM titled “Physician Supplemental Order” evidenced wound treatments orders which stated “... Order Received: 11/12/2021 ... lower left leg venous stasis ulcers ... Cleanse with normal saline, apply betadine to wound, apply silver alginate [aquacel Ag+], dry gauze dressing and compression dressing (Tubi grip) three times weekly or PRN [as needed] if dressing becomes soiled or dislodged ....” The record failed to evidence a wound clinic M note dated 11/11/2021. A document dated and signed by LPN E on 11/15/2021 titled “... SN Visit Note” evidenced the patient rated pain at “8”, wounds were painful to touch, patient squirmed during care, which made wound care difficult to perform, and ALF L staff reported patient was consuming alcoholic beverages. The document failed to evidence the nurse coordinated with staff at ALF L when last pain medication given, or if patient was due for pain medication. A home visit was observed on 11/22/2021 at 10:30 AM with LPN E. The patient presented sitting on her couch, with her left leg elevated on her walker seat, the old dressing was visibly saturated with yellow-colored fluid. Upon removal of old dressing, the (L) lower leg was visibly larger in diameter than the (R) lower leg, “way worse” per LPN E, was firm, red, edema present from knee distal through toes, copious clear yellow fluid draining from lateral shin, and LPN E indicated the patient had an appointment with an infectious disease physician later today (11/22/2021). During wound care, the patient complained of severe pain, indicated her leg was hot, burning, very painful, made the nurse stop wound care several times to take a break, and asked for pain medication, to which LPN E indicated she didn’t know if it was time for her pain medication(s). The patient moaned in pain, and yelled out several times during wound care. During this time, an open area was observed by the surveyor on left inner/front ankle, approximately the size of a dime, with a yellow wound bed, several other small open and/or scabbed areas, and generalized dry, scaly skin on the lower extremity. Upon completion of the wound care at 11:35 AM, ALF L staff nurse O administered pain medication(s). After the visit was completed, LPN E, the surveyor, and ALF staff nursing manager N met to discuss the patient. When asked if the patient would benefit from pre-medicating for pain prior to wound care, LPN E indicated it would be hard to pre-medicate because she never knew when she was going to get there to do the wound care, and ALF staff nursing manager N indicated pre-medicating for pain would benefit the patient. A document dated and signed by LPN E on 11/22/2021 titled “... SN Visit Note” stated “... Wound care completed as ordered. Patient tolerated fairly well. Patient had pain medication 2 hours prior to my visit and was not allowed any more at this time ... MD is to come to the facility one day this week and address the pain ....” A document dated and signed by LPN E on 11/26/2021 titled “Missed Visit Note” indicated the patient taken was taken by ambulance to the hospital just prior to her arrival for a nursing visit for unknown diagnosis at this time. Hospital D documents received and reviewed on 12/06/2021 evidenced a document dated 11/26/2021 titled “Emergency Documentation” evidenced the patient complained of pain and swelling to left lower extremity since Wednesday (11/24/2021), but was admitted with pneumonia, and discharged on 12/01/2021. During an interview on 12/07/2021 at 10:50 AM, when asked who was responsible for the patient’s wound care/management, administrator/RN A indicated the patient went to the wound clinic every week, asked the surveyor if the wound was their (agency) responsibility, indicated they (agency) followed wound care orders, and asked again if they (agency) was supposed to be responsible. When asked if a wound could deteriorate in less than a week, clinical manager B stated “Yes, a wound can deteriorate in less than a week.” administrator/RN A then indicated LPN E sent the patient to the hospital for the worsening wound, and indicated the agency couldn’t control everything or they’d be “God”, they saw the patient twice weekly, and if it worsened, we sent her to the hospital, and also indicated the patient was an alcoholic. During this time, agency corporate person A asked if the patient was malnourished, administrator/RN A stated “... probably ... there’s a lot of issues with her ... she sticks stuff down in her dressing and scratches her legs ....” When asked if her actions caused more wounds, administrator/RN A stated “... Sometimes ya [sic] ... they got worse or got infected ....” When asked if the physician or wound clinic M was made aware of the alcoholism or the patient sticking coat hangers in her dressings and causing new or worsening wounds, administrator/RN A stated, “I don’t know.” During this time, clinical manager B stated, “I just want to make sure it’s reflected that ... [patients #6 and 7 ] ... both go to wound clinic weekly ....” 12. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, certification period 12/07/2021 – 02/04/2021, primary diagnosis unstageable pressure ulcer, sacral (lower back) region, other pertinent diagnoses unstageable pressure ulcer (L) buttock, cellulitis left lower extremity (LLE), unspecified dementia, and dependence on wheelchair, evidenced a document dated and signed by RN G on 12/07/2021 titled “... Start of Care ....” This document indicated the patient had no pain, an unstageable pressure ulcer on the coccyx (tailbone area) which measured 6.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage (a white, yellow, or brown fluid, might be slightly thick in texture, a sign of infection), gray wound bed, with macerated skin around the wound (maceration occurs when skin has been exposed to moisture for too long. A telltale sign of maceration is skin that looks soggy, feels soft, or appears whiter than usual. There may be a white ring around the wound in wounds that are too moist or have exposure to too much drainage); and an unstageable pressure ulcer on the (L) buttock, which measured 5.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage, gray wound bed, and surrounding skin was erythemic (redness of the skin caused by congestion of the capillaries in the lower layers of the skin; occurs with any skin injury, infection, or inflammation). The document also evidenced calmoseptine was applied to both wounds, the nurse was going to see the patient twice weekly, and FNP (family nurse practitioner) C was scheduled to see the patient 12/08/2021 for wound care orders. A document dated and signed by RN G on 12/07/2021 titled “Home Health Certification and Plan of Care” for certification period 12/07/2021 – 02/04/2021 evidenced skilled nursing twice weekly, and stated “... Apply wound dressing as instructed and prescribed: pressure ulcers to buttoks [sic], calmoseptine daily by Alf [sic] staff after peri care [incontinence care] ... Cleanse wounds with normal saline, pat dry, apply Aquacel AG to wound bed, apply Mepilex. Change 3 times a week and PRN [as needed] ....” This document failed to evidence which order was current, what wounds received aquacel treatment, who performed wound care when no agency staff present, or any treatment to lower leg for diagnosis of cellulitis. A document was received on 12/13/2021 at 11:20 AM, dated 12/09/2021, partially completed, but not signed by administrator/RN A was titled “... SN Visit Note”. During an interview on 12/13/2021 at 11:25 AM, administrator/RN A indicated RN G did the admission on 12/07/2021, and because of the decline in 2 days, (we) increased the frequency and changed wound treatment. When queried if calmoseptine was appropriate for this patient’s wounds, administrator/RN A stated “... No, which is why we called to get another order ....” When queried if RN G spoke with FNP C on 12/07/2021, administrator/RN A stated “... I believe so, but I don’t know for sure ... she did not document if she did or not ....” During this time, clinical manager B indicated the comprehensive assessment dated 12/07/2021 indicated calmoseptine was ordered until FNP saw the patient on 12/08/2021. When queried if aquacel was used for the visit on 12/09/2021, administrator/RN A stated “... Nope, not done with my note for 12/9/2021 ... that [calmoseptine] was the order he sent over on his referral ... Yes, this wound got worse from the 7th to the 9th ....” Clinical manager B also stated “... There’s no way to tell on the 485 [plan of care] which wound treatment is the current one ....” When queried which wound care treatment she administered during the visit on 12/9/2021, administrator/RN A stated “... At that time I just did the calmoseptine and adhesive dressing until I spoke to [FNP C] to get orders ....” When queried if the wound care with aquacel had begun since the order was received on 12/09/2021, administrator/RN A stated “... She’s being seen today, so today it will start ... this is the first visit after it was ordered ....” When queried, administrator/RN A indicated the patient could not ambulate or transfer herself. When queried if there was any concern this patient was too acute for an ALF, administrator/RN A stated “... Ya [sic], possibly ....” .A document was received on 12/14/2021 at 11:54 AM, dated and signed by administrator/RN A on 12/09/2021, titled “... SN Visit Note” evidenced the nurse cleansed wounds with normal saline, patted dry, applied Aquacel AG to wound beds, and applied Mepilex. During an interview on 12/14/2021 at 11:51 AM, administrator/RN A indicated she cleansed the patient’s wounds with normal saline, patted dry, applied Aquacel AG to wound beds, and applied Mepilex on 12/09/2021, and stated “... Yes, I’m changing my answer ... I can’t remember what I do on everybody ....” A home visit was observed on 12/15/2021 at 10:06 AM, with administrator/RN A, RN G and surveyor P also present. Observed a sheet of paper attached on the refrigerator which stated “... compression sock [socks that apply gentle pressure to your legs and ankles, promoting blood flow from your legs to your heart, and help control swelling] on (L) [left leg] ....”, observed patient lying on her left side in bed, with lower-calf length loose-fitting socks on both feet, both feet/lower legs slightly swollen, particularly along and above sock line, RN G removed socks, and LLE was red, dry, and scaly, with skin flaking off. RN G then removed the patient’s incontinence brief tab over the right hip, and exposed wounds which were not covered with dressings. During this time, RN G indicated ALF K knew she was coming, performed incontinence care and removed the dressings prior to our arrival. Six wounds were initially observed; there was a large unstageable pressure ulcer observed on the coccyx, greater in size than the diameter of a baseball (baseball = 7.3-7.5 cm), at least 1.0 cm deep, gray/black wound bed, and small amount of tan slough. Drainage could not be determined due to removal of old dressing; a full-thickness wound (damage extended below all layers of the skin) which bordered the lower part of the coccyx ulcer, located at approximately 7:00 o’clock, with a beefy red wound bed, extending diagonally down, approximately 5.0 -7.0 cm x 2.0 – 3.0 cm x 0.1 - 0.2 cm, unknown drainage; a wound on the (R) ischium, with undermining at the 12:00 o’clock position; the tissue, when lifted, was yellow slough, and the remaining wound bed was gray/black, size was approximately 3.0 – 4.0 cm in diameter, larger when undermining exposed, and depth at least 1.0 cm, unknown drainage; a full-thickness wound to the upper left of the (R) ischium wound, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep; a full-thickness wound to the lower left of the (L) ischium wound, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep, drainage unknown; a full-thickness wound below the (R) ischial wound on the upper/back thigh, just below the posterior buttock crease, approximately the size of a quarter, beefy red wound bed, at least 0.1 cm deep, drainage unknown. The patient’s skin surrounding all wounds/buttocks area was erythemic. During wound care, RN G applied foam dressings with adhesive borders directly stuck on open wound beds, and indicated to administrator/RN A that she would talk to FNP C about a bigger dressing. During wound care, the patient yelled out in pain, flinched, grabbed at wounds, and yelled for the nurse to stop. After this wound care was completed, Surveyor P asked RN G to assess the patient’s back prior to turning her over. The patient’s back was exposed, and an unstageable wound was observed on the patient’s right lateral (side) trunk, mid- thoracic level (from shoulder level and downward to upper level of lower back), approximately 1.0 – 2.0 cm x 3.0 4.0 cm x 0.0 cm, the center of the wound was dark purple/black, surrounding skin erythemic; and a long dark red/purple line approximately 5-6 inches in length along the right-side waistline/crease with no open area. During this time, administrator/RN A indicated the patient always leaned to that side (right) when she was seated up in a chair. Both areas were left open to air (OTA). RN G and administrator/RN A turned patient over onto her right hip, and an additional wound was observed, which was approximately 5.0 cm x 10.0 cm x 0.0 cm, raised and swollen, boggy upon touch by RN G, dark purple with erythemic skin around wound, and an open area on the distal portion of this wound which was approximately 1.0 – 2.0 in diameter, approximately 0.1 -0.2 cm deep, with a red wound bed and white pinpoint size areas. During this visit, RN G did not measure any wounds with an actual measuring device. When asked, RN G indicated she had a ruler in her car; when asked how she determined wound depth, she indicated the wounds had no depth. When the patient was positioned onto her right side after all care was completed, she yelled out in pain as her leg was lifted to prop a blanket between her knees. A total of 9 wounds were identified during this home visit. During an interview on 12/15/2021 at 11:00 AM (immediately after the home visit at ALF K), when asked if ALF K staff assessed patient wounds at this facility, administrator/RN A indicated she did not know. During this time, RN G indicated she just talked to ALF K staff to request a hospital bed and a special mattress. When asked if the agency provided social work services, administrator/RN A indicated the agency did, but this facility had their own. A document dated and signed by RN G on 12/15/2021 titled “... SN Visit Note” evidenced the nurse documented only 6 wounds, identified the ischial (buttock) wound as located on the left side, when it was actually on the right ischium, documented the coccyx wound as 1.0 cm in depth, left buttock as 1.0 cm in depth, and all other wounds as < 0.1 cm in depth; documented the patient’s pain was a “4”, aching, and the patient had no pain medications ordered; and documented the patient had no new pressure ulcers identified this visit. An undated document received from ALF K on 12/17/2021, titled “Medication Record” evidenced norco (narcotic pain medication) was ordered on 12/08/2021 to be given every 8 hours as needed for moderate to severe pain, and tylenol was ordered 12/08/2021to be given every 6 hours as needed for mild pain. 13. During an interview on 12/14/2021 at 11:14 AM, clinical manager B indicated the agency did have a lot of patients, their growth occurred within the last 60 days, (agency) would stop taking patients until they "got this pulled together", she knew that you (surveyor) reviewed charts with patients that were hospitalized, but no one can be sure that it was our fault; she knew re-hospitalization rate in Indiana was 15% and (agency’s) is 19%, and queried when the re-hospitalization data was obtained, clinical manager A stated “... like within the last 6 months, I think ... we cannot be there 24/7 ....”

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all patients received the home health services that were written in the plan of care, and/or ensured the patient’s plan of care was individualized for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Care Planning Process” stated “... A written plan of care ... includes ... Frequency and duration of visits ... Individualized patient needs ... will be revised as frequently as deemed necessary ... Revision dates will be noted on the plan of care ... will be based on changes in the patient’s health status, needs ... Services to be provided will be based on the prioritized needs of the patient ... Problems and/or needs related to the patient’s condition, desires, abilities, family/caregiver support systems, and relevant medication monitoring will be included in the plan of care ....” 2. A web-based reference was reviewed on 12/13/2021, at https://medlineplus.gov/ency/patientinstructions/000462.htm, titled “Peripherally inserted central catheter [PICC] - dressing change” which stated “... A peripherally inserted central catheter (PICC) is a long, thin tube that goes into your body through a vein in your upper arm. The end of this catheter goes into a large vein near your heart ... It helps to know the name of your catheter and what company makes it. Write this information down and keep it handy ... A dressing is a special bandage that blocks germs and keeps your catheter site dry and clean. You should change the dressing about once a week. You need to change it sooner if it becomes loose or gets wet or dirty ... 3. A web-based reference was reviewed on 12/13/2021, at https://www.ahrq.gov/sites/default/files/wysiwyg/hai/clabsi-tools/central-venous-access-device-dressing-change-procedure.pdf, titled “IV Therapy Central Venous Access Device ... Dressing Change Procedure” which indicated the clinician and patient should both wear masks during the dressing change, the dressing change is a sterile procedure, sterile field is created with the sterile glove package or central line dressing kit drape, document catheter length, dressing change and site assessment. 4. Record review for patient #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer (wound caused by unrelieved pressure, no deeper than all layers of the skin, and includes intact or ruptured blisters) of left buttock, and other diagnoses included stage 2 pressure ulcer of right buttock, parkinson’s disease, essential (primary) hypertension (high blood pressure), anxiety disorder, delusional disorder, gout, encounter for change or removal of dressing, gastro-esophageal reflux disorder (GERD) (indigestion), and long term (current) use of non-steroidal anti-inflammatories (NSAID). Record review evidenced a comprehensive assessment dated and signed by RN (registered nurse) G on 10/29/2021, titled “... Recertification [comprehensive reassessment]....”, which indicated the patient resided at ALF (assisted living facility) Q (based on documented address), was at risk for development of pressure sores, open area to left ankle which was believed to be a pressure ulcer, had a stage 2 pressure sore on the right (R) buttock, a "healed" pressure sore to the left (L) buttock, was incontinent of bowel and bladder, she was disoriented (temporary or permanent state of confusion), had a risk for skin breakdown, needed help for personal care, risk for falls, nutritional deficit risk, ALF staff was not permitted to perform wound care at level needed, and stated “... Significant lab findings ... [box checked] ... N/A [not applicable] ....” A document dated and signed by RN G on 10/29/2021, titled “Home Health Certification and Plan of Care” for certification period 11/02/2021 – 12/31/2021, evidenced orders for skilled nursing, frequency of 2 times weekly, and a low sodium diet. The record failed to evidence the nurse saw the patient twice during the first week of the certification period, or documented why the second visit during this week was not made. The document also failed to evidence the plan of care included individualized interventions or patient-specific goals related to low sodium diet, parkinson’s disease, hypertension, anxiety disorder, delusional disorder, gout, or GERD. 5. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, primary diagnosis dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) on 9/21/2021, encounter for attention to gastrostomy (g tube), atherosclerotic heart disease (hardening of the arteries), hypertensive chronic kidney disease (high blood pressure caused by the narrowing of your arteries that carry blood to your kidneys), end stage renal disease (kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life), dependence on dialysis, and history of old myocardial infarction (heart attack) and coronary angioplasty (a medical procedure in which a balloon is used to open a blockage in an artery in the heart); and certification period 11/23/2021 – 1/21/2021, primary diagnosis pressure ulcer of sacral (lower back) region added on 11/02/2021, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) added on 11/02/2021, dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) added on 11/02/2021, and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) added on 10/12/2021. A document dated and signed by RN I on 9/24/2021, titled “... Start of Care ... [initial comprehensive assessment] ....” evidenced the patient was dependent on dialysis every Monday, Wednesday and Friday, experienced an unintentional weight loss of 10 pounds or more in the last 12 months, history of falls, 2 or more hospitalizations in the past 6 months, aspiration precautions (ingestion of foreign objects, food or fluids into the lungs), experienced dizziness, reported pain, very poor nutrition, risk for skin breakdown, g tube placement on 9/21/2021, high blood pressure, pitting edema (dent left in extremity when pressed with finger due to fluid retention), able to take in nutrients orally, received supplemental tube feedings, received some medications via g tube, was on a renal diet (low in sodium, phosphorous, and protein, and also emphasizes the importance of consuming high-quality protein, and usually limiting fluids) with 1500 ml (milliliter) fluid restriction, received 8 ounces of Nepro (supplemental feeding) via g tube QID (4 times daily), and had a right upper arm fistula (venous access for dialysis). A document dated and signed by RN I on 09/24/2021 titled “Home Health Certification and Plan of Care” for certification period 09/24/2021 – 11/22/2021, evidenced skilled nursing (SN) was ordered 1 time the first week, 2 times per week during the second week, then weekly for 7 weeks; physical therapy (PT) was ordered 2 times weekly for 4 weeks; and occupational therapy (OT) was ordered 1 time per week for 1 week. The document also evidenced a section titled “Goals ....”, which stated “... [SN] ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ... Patient and/or caregiver will identify measures to prevent skin breakdown and remain free of skin breakdown throughout the cert [certification] period ... Patient/caregiver effective in ostomy/tube [g tube] feeding management and knows the number and should be called for questions or concerns by end of SNV’s [skilled nursing visits] ... Patient/caregiver will verbalize understanding of s/s [signs/symptoms] of aspiration and how to prevent throughout the cert period ... [PT] [goals] ... Demos [demonstrates] increased strength and coordination by certs end ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ... [OT] [goals] ... Safety in ADLs [activities of daily living] throughout the cert period ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ....” The record failed to evidence the PT or OT saw the patient during the first week of the certification period, or document why the visits were not made; and failed to evidence the PT made a second visit during the second week of the certification period, or document why the visit wasn’t made. The document also failed to evidence the plan of care included individualized information which included where and when the patient attended dialysis, the presence of the right arm fistula, who assessed/cared for the fistula, which medications were administered via g tube, patient-specific goals related to cardiovascular disease management, nutrition/weight loss, or patient specific PT/OT goals. Review of a document dated and signed by PT J on 09/28/2021, unsigned by the certifying physician, titled “... PT Evaluation” evidenced additional goals not included on the patient’s plan of care, and stated “... Will reduce or eliminate risk of falls by 10/22/21 ... Demonstrate compliance with prescribed therapeutic exercises by 10/22/2021 ....” Review of a document dated 09/30/2021, signed by OT K on 10/01/2021, unsigned by the certifying physician, titled “... OT Eval and CP [care plan]” evidenced OT frequency of 1 visit for the first week, then 2 times weekly for 4 weeks, and stated “... Safety in ADLs ... mod I BADLS [sic] and simple IADLs [instrumental activities of daily living] by 10/29/21 ....” During an interview on 12/07/2021 at 1:54 PM, when queried if she would expect to see interventions for nutrition on the plan of care, administrator/RN A stated “Yes.” When queried if dialysis location/frequency, and (R) upper arm fistula should be on the plan of care, administrator/RN A indicated most of the time the fistula was covered, so they didn’t touch it, and it should be on the plan of care. During this time, clinical manager B indicated she didn’t really want to discuss every item, or we’d be here forever. When queried if the PT evaluation dated 09/28/2021, was signed by the physician as part of the plan of care, clinical manager B stated “... if it’s reflected on the plan of care, we don’t send it.” When queried if the OT evaluation dated 09/30/2021, was signed by the physician as part of the plan of care, clinical manager B stated “... No ... again ... if it’s on the plan of care, we don’t send it to the physician to sign ....” A document dated and signed by RN I on 11/18/2021, titled “Home Health Certification and Plan of Care” for certification period 11/23/2021 – 01/21/2022, evidenced SN was ordered 2 times per week for 4 weeks, then once weekly for 5 weeks; and PT, OT, and speech language pathologist (SLP) were ordered 1 time per week for 1 week. The record failed to evidence the PT, OT, or SLP saw the patient; and failed to evidence the nurse saw the patient at all during the first week of the certification period, and made only 1 visit the second week of the certification period. A document dated 11/24/2021, titled “Physician Supplemental Order” stated “... Decrease SN visits to 1x [1 time] a week eff [effective] week of 11/24 per patient request ....” The document evidenced it was requested by RN I, but failed to evidence RN I or the certifying physician’s signature. During an interview on 12/9/2021 at 12:26 PM, when queried who wrote/last modified the unsigned physician’s order dated 11/24/2021, clinical manager B indicated administrator/RN A created the order on 12/07/2021. When queried how the patient requested a decrease in nursing visit frequency if she was in the hospital, clinical manager B had no response. A hospital D document dated 11/25/2021, titled “Discharge Summary” evidenced the patient was admitted for observation and treatment on 11/24/2021, and discharged on 11/25/2021. A document dated and signed by RN I on 11/26/2021, titled “Case Conference and Care Coordination” stated “... Received call from [family member] ... patient is coming home from hospital today ... family in town due to holiday ... would like to ... hold off on a visit until next Thurs 12/22 ....” During an interview on 12/1/2021 at 1:35 PM, family consented for the surveyor to read and photograph text messages between herself and RN I. Family indicated she informed the registered nurse (on 11/21/2021) that the patient's blood pressure was “running high”, the nurse did not make a visit to assess the patient, the nurse texted to check on the patient's blood pressure on 11/22/2021, during which time family indicated she didn't write her blood pressure readings down, indicated to the nurse "something has changed, we took a big step backwards", the nurse did not make a home visit to assess the patient, and the patient was subsequently seen in the ED (emergency department), and hospitalized 11/24/2021- 11/25/2021 in observation status, for hypertension and NSTEMI (a type of heart attack involving partial blockage of one of the coronary arteries) with stent placement. On 11/27/2021, family texted the nurse to inform patient was home from hospital, and the nurse replied to let her know when she'd like a visit, but did not offer to visit on that date. When asked if she would have accepted a visit from the nurse if she offered to come on 11/27/2021, family said "Of course". As of 12/1/2021, the patient was not seen by the nurse or SLP. During an interview on 12/07/2021 at 2:37 PM, when queried if the patient received OT, administrator/RN A stated “... I believe she refused ....” When queried if SLP saw the patient, administrator/RN A stated “... No, she went back in the hospital and didn’t want it after that ... I’m going by what [RN I] said ....” The clinical record failed to evidence the patient declined SLP. 6. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis Alzheimer’s disease, unspecified, secondary diagnoses of dementia, repeated falls, essential (primary) hypertension (high blood pressure), type 2 (adult onset) diabetes, major depressive disorder, anxiety disorder (unspecified), long term (current) use of aspirin, and history of falling. Record review evidenced a document dated 08/20/2021, and signed by PT J on 08/30/2021, titled “... PT Start of Care ....” which indicated the caregiver’s stated goal was for the patient to return to previous walking ability with a rolling walker (RW), and stated “... poor endurance and is a high risk for falls and injury ... impaired judgement with poor safety awareness ....”. A document dated and signed by PT J on 08/30/2021, titled “Home Health Certification and Plan of Care” for certification period 08/20/2021 – 10/18/2021, indicated PT was ordered 1 time for the first week, then twice weekly for 3 weeks; and beginning 08/31/2021, OT was ordered once weekly for 1 week. The document also evidenced a section titled “Goals ....”, which stated “... [PT] [goals] ... Demonstrate compliance with prescribed therapeutic exercises by 9/10/21 ... reduce or eliminate risk of falls by 9/10/21 ... Demos [demonstrates] safe effect [sic] use of adaptive services by 9/10/21 ... Demos increased strength and coordination by 9/10/2021 ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ... [OT] [goals] ... Safety in ADLs throughout the cert ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ....” The document failed to indicate the plan of care included individualized information which included caregiver stated goals, or patient-specific goals related to poor endurance, or impaired judgement with poor safety awareness. A document dated 09/08/2021, signed by PT J on 09/12/2021, titled “Physician Supplemental Order” stated “... PT to continue 2 x week for 2 weeks ... starting week of 09-13-2021 ....” The record failed to evidence a second PT visit was made during the week of 09/12/2021, or evidence documentation of why the visit failed to be made or rescheduled. 7. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis of Alzheimer’s disease (unspecified), secondary diagnoses included dementia, repeated falls, major depressive disorder, anxiety disorder (unspecified), essential (primary) hypertension (high blood pressure), hyperlipidemia (high cholesterol (unspecified), hypothyroidism (unspecified), and history of falling. Record review evidenced a document dated 10/29/2021, signed by PT J on 11/02/2021, titled “... PT Start of Care ....” This document indicated the physical therapist was scheduled for 1 visit the first week, then twice weekly for 4 weeks; and OT was ordered twice weekly for 3 weeks, and then once for the 4th week. The record indicated only 1 visit was made by both PT and OT for the week of 09/14/2021, and failed to document why the second visits weren’t made. An agency document signed by PT J on 11/02/2021, titled “Home Health Certification and Plan of Care” for certification period 10/29/2021 – 12/27/2021, evidenced a section titled “Goals ....”, which stated “... [PT] [goals] ... Will reduce or eliminate the risk of falls ... Demonstrate compliance with prescribed therapeutic exercises by ... Progressive independence in mobility by ... Demos increased strength and coordination by ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ... [OT] [goals] ... Progressive participation in activities of daily living by ... Progressive independence in mobility by ... reduce or eliminate risk of falls by ... Patient will be prepared for discharge and family or caregiver will be knowledgeable on available community resources ....” The document failed to evidence the plan of care included individualized patient goals. 8. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, primary diagnosis type 2 (adult onset) diabetes with foot ulcer (open wound), other diagnoses included diabetes with chronic kidney disease, stage 3 chronic kidney disease, anemia in chronic kidney disease, hypothyroidism, benign prostatic hyperplasia (BPH) (enlarged prostate which causes urinary retention), vitamin D deficiency, personal history of urinary tract infections (UTIs), and history of falling. Record review evidenced a document dated and signed by administrator/RN A on 09/08/2021, titled “... Start of Care ....” This document indicated the patient lived in an ALF, was confined to a chair, had a right above knee amputation, required assistance for dressing and bathing, blood sugar was tested daily before meals and at bedtime, had blood tested for HgbA1c (a blood test to determine average blood sugars over the past 2-3 months), required a size 16 french (fr) indwelling urinary catheter (a tube inserted into the bladder to drain urine) due to urinary retention, and patient had an upcoming appointment with a wound clinic. An agency document dated and signed by administrator/RN A on 09/08/2021, titled “Home Health Certification and Plan of Care” for certification period 09/08/2021 – 11/06/2021. This document failed to include which wound clinic the patient attended, or patient-specific goals related to UTIs, and kidney disease. 9. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis of non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses of non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), essential primary hypertension, iron deficiency anemia secondary to blood loss (chronic), diverticulosis (a condition that causes pouches to form in the large intestine that may become inflamed and infected) of large intestine without perforation, and personal history of COVID-19 (04/27/2021). Record review evidenced a document dated and signed on 10/22/2021, by RN I titled “... Recertification ....” This document indicated the patient had 4 or more stasis ulcers (wounds caused by impaired circulation), resided at ALF L, and previously lived at home, had a fall which resulted in a brain injury, bruised easily, had chronic redness to lower extremities, swelling to lower extremities, mental status included depression, was at high risk for falls, and was a nutritional deficit risk. An agency document dated and signed by RN I on 10/21/2021, titled “Home Health Certification and Plan of Care” for certification period 10/25/2021 – 12/23/2021, evidenced orders for skilled nursing 2 times weekly for 9 weeks to provide wound care, indicated a cardiac diet, and indicated mental status included depression. The document failed to evidence the plan of care included which wound clinic the patient attended, or how often, who the patient’s cardiologist was (who also prescribed/changed medications), or contact information, or patient-specific goals related to a cardiac diet, depression, diverticulosis, or hypertension. A home visit was observed on 11/19/2021 at 10:30 AM, with LPN E. When queried, LPN E indicated the patient was seen at wound clinic M, and the patient saw cardiologist Z, she saw him last week, and she was supposed to be getting a pacemaker implanted soon. During an interview on 12/07/2021 at 10:50 AM, when queried who was responsible for wound care/management, administrator/RN A and clinical manager B both indicated patients #6 and #7 both went to wound clinic weekly, and administrator/RN A questioned if the patients’ wounds were the agency’s responsibility. 10. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis of chronic obstructive pulmonary disease (lung disease), hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow) and dependence on supplemental oxygen. Record review evidenced a comprehensive assessment dated and signed by RN G on 10/26/2021, titled “... Recertification ....” This document indicated 2 wounds documented as: a stasis ulcer (L) leg, black wound bed, no odor; and an open wound (L) leg, pale pink wound bed, small amount serosanguinous drainage, with no evidence of infection documented. The document indicated assisted living facility (ALF) L was not permitted to perform wound care, patient had pain daily but not constantly, and pain was rated by patient as “8” [on a scale of 0 – 10, with 0 being no pain and 10 the most severe], in (L) leg, and stated “... numeric [pain] scale ... 0: None ... 7-9: requires MD [physician] intervention ....” The document also indicated the patient’s usual food intake pattern was probably inadequate, was a nutritional deficit risk, became short of breath with minimal exertion, attended wound clinic weekly, and wounds were “slow healing”. An agency document dated and signed by RN G on 10/26/2021, titled “Home Health Certification and Plan of Care” for certification period 10/30/2021 – 12/28/2021, evidenced a goal which stated “... verbalize importance of prescribed high-calorie, high protein diet, vitamin, mineral supplements, adequate fluid intake ....”, but the section titled “Nutritional Req. [requirements]”indicated the patient’s diet was low sodium and low cholesterol; and oxygen therapy at 4 liters (per minute) per nasal cannula (tube inserted into nostrils). The document failed to evidence patient specific information, which included contact information for ALF L, if the patient used oxygen intermittently or continuous; or patient-specific goals related to the patient’s pain, nutritional deficit risk, use of alcohol, or use of coat hangers to scratch at skin. A hospital D document dated 11/04/2021, titled “History and Physical Reports” indicated the patient was admitted on 11/03/2021, and discharged on 11/08/2021. This document indicated the patient complained of increased pain, redness and swelling to (L) lower leg, which spread up back of leg, for 2 days; and was admitted with cellulitis which required treatment with intravenous (IV) antibiotics. The document also indicated the patient was a current daily beer drinker. An agency document dated 11/9/2021, and signed by administrator/RN A on 11/11/2021, titled “Physician Supplemental Order ....” failed to evidence alcohol abuse was identified during nursing visits. Alcohol abuse had the potential to affect the patient’s plan of care and outcomes. During an interview on 12/07/2021 at 10:50 AM, when asked who was responsible for the patient’s wound care/management, administrator/RN A indicated the patient went to the wound clinic every week, asked the surveyor if the wound was their (agency) responsibility, indicated they (agency) followed wound care orders, and asked again if they (agency) were supposed to be responsible. When queried if a wound could deteriorate in less than a week, clinical manager B stated “Yes, a wound can deteriorate in less than a week.” Administrator/RN A then indicated LPN E sent the patient to the hospital for the worsening wound, and indicated the agency couldn’t control everything or they’d be “God”, she indicated they saw the patient twice weekly, and if it worsened, they sent her to the hospital, and also indicated the patient was an alcoholic. During this time, agency corporate person A asked if the patient was malnourished, administrator/RN A stated “... probably ... there’s a lot of issues with her ... she sticks stuff down in her dressing and scratches her legs ....” When queried if her actions caused more wounds, administrator/RN A stated “... Sometimes yeah ... they got worse or got infected ....” When queried if the physician or wound clinic M was made aware of the alcoholism or the patient sticking coat hangers in her dressings and causing new or worsening wounds, administrator/RN A stated, “I don’t know.” When queried if the patient’s alcohol use and scratching with coat hangers had the potential to impact the plan of care, clinical manager B stated “Yes.” When queried if she would expect to see that information on the plan of care, clinical manager B stated “Yes.” 11. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis unspecified open wound, right lower leg, subsequent encounter, and secondary diagnoses of unspecified open wound, left lower leg, subsequent encounter, unspecified juvenile rheumatoid arthritis, essential (primary) hypertension (high blood pressure), adjustment disorder with depression, hypothyroidism, unspecified urinary incontinence, and history of falling. Record review evidenced a document dated and signed on 06/09/2021, by administrator/RN A titled “... Recertification ....” This document indicated the patient was chairfast (ability to walk severely limited or non-existent, could not bear own weight and/or must be assisted into chair), was oriented, continued to have multiple falls, needed skilled nursing for wound care, and stated “... Requires home care services [greater than] twice weekly, who would possibly have adverse consequences if services were delayed ... Apply wound dressing as instructed ... Change twice weekly and prn [as needed] ... patient agrees to skilled nursing [once weekly] ... Patient states he continues to have falls, refuses PT/OT ....” An agency document dated and signed by administrator/RN A on 06/11/2021, titled “Home Health Certification and Plan of Care” for certification period 06/11/2021 – 08/09/2021, stated “... Orders for Discipline and Treatments (Specify Amount/Frequency/Duration) ... Skilled Nursing ... Apply wound dressing as instructed ... Change twice weekly and prn ... Goals ... demonstrates compliance to prescribed physical therapy ....” The document failed to evidence patient specific information which included the use of a motorized wheelchair which contributed to his injuries; and failed to evidence patient specific goals for hypertension, adjustment disorder with depression, or urinary incontinence. An agency document dated and signed by administrator/RN A on 06/16/2021, (Wednesday) titled “Missed Visit Note” indicated the patient refused service this date, and the record failed to evidence any other visits were attempted or rescheduled the week of 06/13/2021 – 06/19/2021. The home health agency failed to follow the plan of care. An agency document dated and signed by administrator/RN A on 06/23/2021, (Wednesday) titled “Missed Visit Note” indicated the patient refused service this date, and the record failed to evidence any other visits were attempted or rescheduled the week of 06/20/2021 – 06/26/2021. An agency document dated and signed by administrator/RN A on 06/30/2021, titled “... SN Visit Note” stated “... Patient continues to fall, refuses PT ....” An agency document dated and signed by LPN H on 07/02/2021, titled “... SN Visit Note” stated “... New Wound to L [left] posterior calf ....” An agency document dated and signed by administrator/RN A on 07/07/2021, titled “... SN Visit Note” stated “... Patient states he is not sleeping well at night ....” The document indicated the patient had 1 wound to the left posterior calf, no other wounds, and the record failed to evidence any other visits were attempted between of 07/08/2021 – 07/15/2021. If the plan of care ordered skilled nursing 1 time weekly, why would another visit need to be made? During an interview on 12/13/2021 at 2:36 PM, when queried why the patient was only seen once weekly, when the plan of care evidenced wound care was to be performed twice weekly, clinical manager B did not respond. An agency document dated and signed by LPN H on 07/16/2021, titled “... SN Visit Note” indicated the patient experienced a fall resulting in an injury and was seen in the ED [emergency department] (unknown date). This document indicated the patient sustained severe skin tears to the right wrist, right elbow, 2 skin tears to the right shin, a skin tear to the right calf, and the left posterior calf wound was ongoing; and also indicated the patient sustained ecchymosis (bleeding under the skin/bruising) to the right forehead and eye socket, and the patient could not remember how the skin tears occurred. The document stated “... Observed to use scooter [motorized wheelchair] unsafely ... endangering patient and others around him ... manual wheelchair would be safer ... Patient admitted that ‘sometimes I scare myself’ ....” The clinical record failed to evidence any further nursing visits were attempted through 07/20/2021. An agency document dated and signed 07/20/2021, by administrator/RN A titled “... Transferred to an Inpatient Facility ....” stated “... Patient admitted to [hospital HH] ....” 12. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood), permanent atrial fibrillation (irregular heart rhythm), dilated cardiomyopathy (weak heart muscle which causes inability to pump blood efficiently throughout the body), heart failure, end stage renal (kidney) disease, dependence on renal dialysis, major depressive disorder, and long term use of anticoagulants (blood thinners). Record review evidenced a document dated and signed by administrator/RN A on 04/30/2021, titled “... Start of Care ....” which indicated the patient was a high fall risk, blood sugar was tested daily, diabetes was diet controlled, was at risk for skin breakdown, had a right arm fistula and a right permacath (venous access for dialysis), became short of breath when walking more than 20 feet or climbing stairs, patient had an appointment with her nephrologist (kidney doctor) “next week”, was not eating much, the nurse performed a blood draw for PT/INR (a blood test to determine therapeutic level for blood thinner), and the results were called into the physician. An agency document dated and signed by administrator/RN A on 04/30/2021, titled “Home Health Certification and Plan of Care” for certification period 04/30/2021 – 06/28/2021, failed to indicate patient specific information, which included blood sugar was checked daily, who checked it, or parameters of results to notify agency/physician, presence of right arm fistula and a right permacath, where the patient attended dialysis, or when the next PT/INR was due to be drawn; and failed to evidence patient specific goals for fall risk, blood sugar results, diabetes controlled by diet, poor intake, risk for skin breakdown, or diagnoses which included COVID-19, pneumonia due to coronavirus, atrial fibrillation, heart failure, or end stage renal disease. During an interview on 12/13/2021 at 2:15 PM, when queried if she would have expected an RN to follow up after the findings on 05/05/2021, clinical manager B stated “... Yes, definitely ....” 13. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses of pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection, paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, and bed confinement status. Record review evidenced a document dated and signed by RN I on 11/07/2021, titled “... Start of Care ....” This document indicated the patient with complex needs received SN services 4 times per week for 1 week, then 3 times per week for 7 weeks, then 2 times per week for 1 week, and 3 “as needed” visits; the nurse provided complex wound care, which included NPWT (negative pressure wound therapy) (a vacuum sealed wound treatment device/Wound VAC), IV antibiotic medication administration, lab draws via PICC (a tube inserted into a smaller vein, extending up to a larger vein for administration of medications), blood sugar was monitored daily, patient’s family to obtain glucometer and insulin syringes, patient attended dialysis on Tuesdays, Thursdays and Saturdays from 7:00 – 12:00 (not specified AM or PM), weekly CBC (complete blood count), Sed Rate (test to reveal inflammatory activity in the body), CRP (test to reveal inflammatory activity in the body), CMP (fluids and electrolytes) with results to infectious disease physician JJ, and IV supplies provided by supply company KK. An agency document dated and signed by RN I on 11/07/2021, titled “Home Health Certification and Plan of Care” for certification period 11/07/2021 – 01/05/2022, evidenced SN services 4 times per week for 1 week, then 3 times per week for 7 weeks, then 2 times per week for 1 week, and 3 “as needed” visits; and stated “... SN to assess/perform weekly PICC/Central line care ... SN/Patient/PCG [patient’s caregiver] will flush [PICC] line with 10cc [cubic centimeters] sterile normal saline before, after infusion of antibiotic/medication and before and after lab draws ... wound VAC ... Change [wound vac] 3xwk [3 times per week] ....” The document failed to evidence patient specific information, which included the patient’s bodily location of the PICC, when the PICC dressing was last changed, date next due to be changed, when the wound vac was scheduled to be changed, blood sugar was monitored daily, who performed the task, parameters of results to notify agency/physician, patient’s family to obtain glucometer and insulin syringes, or schedule, location, contact information of dialysis treatment center, weekly CBC, Sed Rate, CRP, and CMP, with results to infectious disease physician JJ, physician JJ’s contact information, IV supplies provided by supply company KK, or contact information for supply company KK; and failed to evidence patient specific goals for UTI, diabetes, hypertensive heart and chronic kidney disease with heart failure, or caregiver competency with wound care and PICC care/administration of medications/flushes. During an interview on 12/02/2021 at 2:16 PM, family indicated the patient went into the hospital on 11/14/2021 or 11/15/2021, and prior to that, a family member did the IV infusions and wound care on the days when RN I wasn’t there. An unsigned document dated 11/09/2021, initiated by RN I (visit #3 of 4 for the first week of service) stated “... Wound vac to be changed tomorrow ... family is overwhelmed with her care ....” The record failed to evidence a fourth visit was conducted the week of 11/07/2021. An agency document dated and signed by RN I on 11/12/2021, titled “Missed Visit Note” stated “... There was no answer at door ... no answer via cell phone ....” During an interview on 12/13/2021 at 1:46 PM, when queried if the patient’s record evidenced any follow up for the missed visit on 11/12/2021, to determine the patient’s safety, clinical manager B stated “...No.” When queried if the record evidenced a nurse attempted to see the patient on 11/10/2021 or 11/11/2021, clinical manager B indicated there was not. A document received from hospital EE on 12/06/2021, dated 11/15/2021, titled “ED Triage Notes ....” stated “... C/C [chief complaint] fever of 105 [degrees], lethargic ....” A document received from hospital EE on 12/06/2021, dated 11/15/2021, titled “... Emergency Department Encounter” stated “... [diagnoses] included but not limited to: Sepsis [whole body system infection] secondary to bedsores, UTI, pneumonia, intra-abdominal infection ... admitted in serious but relatively stable condition ....” 14. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, certification period 12/07/2021 – 02/04/2022, primary diagnosis unstageable pressure ulcer, sacral (lower back) region, other pertinent diagnoses unstageable pressure ulcer (L) buttock, cellulitis left lower extremity (LLE), unspecified dementia without behavioral disturbance, major depressive disorder, recurrent (unspecified), essential (primary) hypertension), and dependence on wheelchair. Record review evidenced a document dated and signed by RN G on 12/07/2021, titled “... Start of Care ....” This document indicated the patient received SN twice weekly for wound care, the patient had no pain, an unstageable pressure ulcer on the coccyx (tailbone area) which measured 6.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage (a white, yellow, or brown fluid, might be slightly thick in texture, a sign of infection), gray wound bed, with macerated skin around the wound (maceration occurs when skin has been exposed to moisture for too long); and an unstageable pressure ulcer on the (L) buttock, which measured 5.0 cm x 4.0 cm x 1.0 cm, with opaque tan to yellow purulent drainage, gray wound bed, and surrounding skin was erythemic (redness of the skin caused by congestion of the capillaries in the lower layers of the skin; occurs with any skin injury, infection, or inflammation). The document also indicated the patient was chairfast, required moderate to maximum assistance in moving, had incontinence of bladder, was totally dependent for all personal care, fall risk, risk for skin breakdown, calmoseptine was applied to both wounds, and FNP [family nurse practitioner] C was scheduled to see the patient 12/08/2021, for wound care orders. An agency document received on 12/13/2021 at 11:20 AM, dated and signed by administrator/RN A on 12/09/2021 at 3:23 PM, titled “Physician Supplemental Order” stated “... SKILLED NURSING ... Apply wound dressing ... clean ... with NS [normal saline] ... apply aquacel ag [absorptive dressing with silver as an antimicrobial] to wound bed, cover with mepilex [foam adhesive border dressing] ... Change 3x [times] a week and prn [as needed] ....” The record failed to evidence the patient received a third SN visit the week of 12/05/2021, as indicated on the plan of care. An agency document dated and signed by administrator/RN A on 12/07/2021, titled “Home Health Certification and Plan of Care” for certification period 12/07/2021 – 02/04/2022, indicated orders for SN visits 2 times weekly for 9 weeks, but also evidenced orders for SN to provide wound care 3 times per week, and as needed. The document failed to evidence an updated signature date by administrator/RN A after 12/07/2021, and failed to evidence patient specific information which included she resided at ALF K or contact information, which wound clinic was referred; and failed to evidence patient specific goals for cellulitis left lower extremity (LLE), unspecified dementia without behavioral disturbance, major depressive disorder, recurrent (unspecified), essential (primary) hypertension), and fall risk. 15. During an interview on 11/18/2021 at 11:00 AM, when queried if patient preferences and patient’s goals should be on the plan of care, administrator/RN A indicated yes, they were supposed to be. When queried if goals should be based on the patient’s diagnoses, she stated “Yes.” When queried if the plan of care should be individualized, she stated “Yes.” 16. During an interview on 11/30/2021 at 12:30 PM, when queried if the comprehensive assessment was used to create the plan of care, clinical manager B stated “Yes.” When queried if the certification/recertification comprehensive assessment should correlate with the plan of care, clinical manager B stated “Yes.” When queried if the physician should be notified of missed visits, clinical manager B stated “Yep.” 17. During an interview on 12/14/2021 at 11:14 AM, clinical manager B indicated the agency did have a lot of patients, their growth occurred within the last 60 days, (agency) would stop taking patients until they got this pulled together, she knew that the surveyor reviewed charts with patients that were hospitalized, but no one could be sure that it was their fault; she knew re-hospitalization rate in Indiana was 15% and (agency’s) is 19%, and when queried when the re-hospitalization data was obtained, clinical manager B stated “... like within the last 6 months, I think ... we cannot be there 24/7 ....” 17-13-1(a)

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patient’s plan of care included all pertinent diagnoses, the patient’s psychosocial, and/or cognitive status, supplies and equipment needed, prognosis, functional limitations, activities permitted, nutritional requirements, all medications and/or treatments, safety measures to protect against injury, interventions to address underlying risk factors for emergency department visits and hospital re-admission(s), patient and/or caregiver education and training, and/or patient-specific interventions and education for 11 of 11 records reviewed (#1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Care Planning Process” stated “... The clinical plan of care includes ... Pertinent primary and secondary diagnoses ... Safety measures ... Nutritional requirements ... Medications and treatments ... Specific procedures to be performed by therapies ... Supplies and equipment required ... Discharge or referral plans ... Discharge teaching ... Other appropriate items such as precautions and contraindications... will develop the patient plan of care based upon the patient’s identified needs ... Individualized patient needs and resultant problems related to care, functional status, and family/caregiver support system ... Changes in patient’s condition ... Pain and symptom management ... Psychosocial ... needs ... Patient treatment choices ....” 2. A web-based reference was reviewed on 11/18/2021, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2724829/, titled “How to use an article about prognosis”, stated “... Classically, prognosis is defined as a forecast or prediction. Medically, prognosis may be defined as the prospect of recovering from injury or disease, or a prediction or forecast of the course and outcome of a medical condition ... The prognosis is a key element, not only in deciding on appropriate treatment, but also in discussing the opinions of patients or relatives concerning management ....” 3. A web-based reference was reviewed on 11/22/2021, https://www.drugs.com/mtm/nitro-dur-transdermal.html, titled “Nitro-Dur ....”, which stated “... used to prevent attacks of chest pain ... Wash your hands after applying or removing a skin patch ... Do not wear more than one Nitro-Dur patch at a time. Using extra skin patches will not make the medication more effective. Never cut a skin patch. The Nitro-Dur skin patch is usually worn for 12 to 14 hours and then removed. A new patch is put on after a "patch-free" period of 10 to 12 hours. Your doctor may want you to wear the patch for longer or shorter periods of time. Follow your doctor's instructions carefully ... Drinking alcohol can increase certain side effects such as dizziness, drowsiness, feeling light-headed, or fainting ....” 4. Record review for patient #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer (wound caused by unrelieved pressure, no deeper than all layers of the skin, and includes intact or ruptured blisters) of left buttock, and other diagnoses included stage 2 pressure ulcer of right buttock, parkinson’s disease, essential (primary) hypertension (high blood pressure), anxiety disorder, delusional disorder, gout, encounter for change or removal of dressing, gastro-esophageal reflux disorder (GERD) (indigestion), edema (swelling), unspecified, and long term (current) use of non-steroidal anti-inflammatories (NSAID). Record review evidenced a comprehensive assessment dated and signed by RN (registered nurse) G on 10/29/2021, titled “... Recertification [comprehensive reassessment]....”, which indicated the patient resided at ALF (assisted living facility) Q, was at risk for development of pressure sores, had an open area to left ankle which was believed to be a pressure ulcer, had a stage 2 pressure sore on the right (R) buttock, a "healed" pressure sore to the left (L) buttock, was incontinent of bowel and bladder, was disoriented (temporary or permanent state of confusion), at risk for skin breakdown, needed help for personal care, at risk for falls, at nutritional deficit risk, and ALF staff was not permitted to perform wound care at level needed. A home visit was observed on 11/18/2021 at 9:00 AM, with LPN (licensed practical nurse) H. The patient presented sitting in a recliner, slumped to one side, with eyes closed. As LPN H attempted to rouse patient, the patient was observed as resistant, unable to follow simple commands, and verbally and physically resisted attempts by LPN H to remove her eyeglasses. During this time, LPN H indicated the patient could sometimes follow commands, she couldn’t stand up anymore, could barely bear weight, was incontinent of bowel and bladder, could not perform any personal care, and could not sit on the side of the bed without hands on assistance from another person. Observed ALF Q staff and LPN H transferring the patient from chair to bed for wound care. The patient was completely dependent and did not bear weight during transfer. During wound care, LPN H indicated the wound on the right buttock was healed per the registered nurse who assessed her for the recertification visit, the left ischium (sitting bone area) was worse, and the patient was started on antibiotics for wound infection. Supplies observed included a body pillow on the bed for positioning, a seat cushion for recliner/wheelchair, and an electric recliner/chairlift. LPN H also indicated the agency previously talked to family about hospice, she wasn’t eating at all for a while, family started bringing food in, and it helped a little. When queried if the patient’s weight was monitored, LPN H indicated she didn’t know. ALF Q staff then indicated the patient was on a regular diet with supplemental health shakes, and they encouraged the patient to drink milk. A document received from staff at ALF Q on 11/18/2021 at 10:05 AM, titled “... Order Summary Report” stated “... Active Orders As Of: 11/18/2021 ... Diagnoses: ... Abnormal weight loss ... Dementia in other diseases classified elsewhere with behavioral disturbance ... Regular diet ... Healthshakes [sic] two times daily for supplement ... Milk with every meal as tolerated ... monthly Weights ... wheelchair cushion ....”, and current medications (ordered prior to 10/29/2021) included antiseptic mouth wash, atorvastatin (cholesterol lowering), colace (stool softener), lidocaine gel (topical pain relief), melatonin (hormone supplement for sleep), and tylenol. The document also indicated Remeron (a medication to increase appetite and improve mood) was started 06/10/2021, for “abnormal weight loss”, and guaifenesin-DM liquid (cough syrup) was ordered on 10/23/2021. An agency document dated and signed by RN G on 10/29/2021, titled “Home Health Certification and Plan of Care” for certification period 11/02/2021 – 12/31/2021, indicated the patient received skilled nursing services, and was on a low sodium diet; safety measures included ambulation and support during transfers; functional limitations included bowel/bladder incontinence and endurance; activities permitted included up as tolerated, wheelchair, and exercise prescribed; mental status was disoriented, and prognosis was fair; risk for hospitalization, included decline in mental, emotional, or behavioral status in the past 3 months, reported or observed history of difficulty complying with any medical instructions (for example, medications, diet, exercise) in the past 3 months, and the patient took a daily pain medication. The plan of care failed to evidence the patient’s diagnosis of abnormal weight loss, dementia in other diseases classified elsewhere with behavioral disturbance, a regular diet with health shakes two times daily, milk with every meal as tolerated, and monthly weights; failed to evidence equipment included a wheelchair cushion, body pillow, and electric recliner/chairlift; functional limitations included the patient’s inability to ambulate (walk), and activities permitted included the patient was unable to bear weight, was confined to a chair, and required two people for transfers; medications included antiseptic mouth wash, atorvastatin, colace, lidocaine gel, melatonin, tylenol, Remeron, and guaifenesin-DM. Based on observation and LPN H’s own testimony the plan of care failed to include; patient specific interventions and/or training/education to address underlying risks for hospitalization, weight loss, decreased appetite, nutritional risk, risk for falls, risk for new and/or worsening skin breakdown due to immobility, decreased functional status, infection control to include COVID-19, or the target audience for the teaching/education; patient’s psychosocial status included the need for 24 hour supervision, resided at ALF Q, and depended on others for all care; or cognitive status included the patient’s inability to comprehend or retain instruction/teaching. During an interview on 11/30/2021 at 1:30 PM, when queried if nutritional supplements should be included on the plan of care, clinical manager B stated “No ....” When queried if weights should be obtained and other interventions for a patient who rapidly lost weight and clothes were baggy, clinical manager B indicated they should be. 5. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021. The record evidenced a primary diagnosis of dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); and other pertinent diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) on 9/21/2021, encounter for attention to gastrostomy (g tube), atherosclerotic heart disease (hardening of the arteries), hypertensive chronic kidney disease (high blood pressure caused by the narrowing of your arteries that carry blood to your kidneys), end stage renal disease (kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life), dependence on dialysis, and history of old myocardial infarction (heart attack) and coronary angioplasty (a medical procedure in which a balloon is used to open a blockage in an artery in the heart); and certification period 11/23/2021 – 1/21/2021, primary diagnosis pressure ulcer of sacral (lower back) region added on 11/02/2021, and other pertinent and/or new diagnoses included acute systolic (congestive) heart failure (weak or enlarged muscle which prevents blood from being pumped effectively out to the body) added on 11/02/2021, dysphagia, pharyngeal phase, encounter for attention to gastrostomy, pneumonitis due to inhalation (lung inflammation from food, saliva, liquids, or vomit is breathed into the lungs or airways leading to the lungs) added on 11/02/2021, and hypo-osmolality and hyponatremia (excess fluid retention which causes low blood sodium levels) added on 10/12/2021. An agency document dated and signed by RN I on 9/24/2021, titled “... Start of Care ... [initial comprehensive assessment] ....” indicated the patient was dependent on dialysis, experienced an unintentional weight loss of 10 pounds or more in the last 12 months, had a history of falls, 2 or more hospitalizations in the past 6 months, required aspiration precautions (ingestion of foreign objects, food or fluids into the lungs), experienced dizziness, reported pain, had very poor nutrition, was at risk for skin breakdown, had g tube placement on 9/21/2021, high blood pressure, pitting edema (dent left in extremity when pressed with finger due to fluid retention), was able to take in nutrients orally, received supplemental tube feedings, received some medications via g tube, was on a renal diet (low in sodium, phosphorous, and protein, and also emphasizes the importance of consuming high-quality protein, and usually limiting fluids) with 1500 ml (milliliter) fluid restriction, received 8 ounces of Nepro (supplemental feeding) via g tube QID (4 times daily), and had a right upper arm fistula (venous access for dialysis). An agency document dated and signed by RN I on 09/24/2021, titled “Home Health Certification and Plan of Care” for certification period 09/24/2021 – 11/22/2021, indicated the patient’s diet included 8 ounces of Nepro QID, and also indicated she received “Novasource” (a different kind of supplemental feeding) 1 can QID; prognosis was “fair”, and stated “... Risk for Hospitalization: ... History of falls ... Unintentional weight loss ... Multiple hospitalizations ... Multiple emergency department visits ... Decline in mental, emotional, or behavioral status in the past 3 months ... Currently taking 5 or more medications ... Currently reports exhaustion ... other risks not listed ....” The plan of care failed to evidence the patient’s accurate diet as identified in the comprehensive assessment, patient specific interventions and/or training/education to address underlying risks for hospitalization, what the “other risks” were, weight loss, nutritional risk, how to administer g-tube feedings, flushes and medications via g-tube, risk for falls, infection control to include COVID-19, or the target audience for the teaching/education; patient’s psychosocial status included the patient depended on another person to administer g-tube feedings and medications, or cognitive status included the patient’s ability to comprehend or retain instruction/teaching. Hospital D documentation dated 10/12/2021, indicated the patient was hospitalized on 10/04/2021, for nausea/vomiting due to tube feedings and hyponatremia, most likely secondary to excessive free water flushes with tube feeds and was ordered NPO (take nothing orally/by mouth), and was discharged to home on 10/08/2021. A home visit was observed on 11/18/2021 at 12:55 PM, with RN I and family present. This visit was a recertification, comprehensive reassessment, and plan of care update. During this time, RN I indicated she previously spoke with family about palliative or hospice services due to the patient’s poor condition, family indicated she called physician R (the patient’s primary care physician (PCP)) to refill reglan (medication to treat GERD, nausea and vomiting) and tramadol (opiate/narcotic pain medication), the patient didn’t take norco (opiate/narcotic pain medication) since the tramadol was started, but since she was out of tramadol, she was taking the norco, the patient was finishing up a round of antibiotics, the patient had imodium (anti-diarrheal) but hasn’t needed it recently, and the patient’s g-tube feeding consisted of 8 ounces of NeoSure (a brand of tube feeding) 3 times daily with 1 cup of water, flushed with water before and after feedings and administration of medications. Also, during this time, RN I indicated the hub (where tube meets opening in skin) of the g-tube was at position #5. Supplies observed included a blow-up air cushion on the patient’s recliner, a cushion on the wheelchair, and a humidifier with vicks vapopads (mentholated packet to add to humidifier). An agency document dated and signed by RN I on 11/18/2021, titled “Home Health Certification and Plan of Care” for certification period 11/23/2021 – 01/21/2022, indicated diet was 8 ounces nepro per gravity feeding with 1 cup water flush after feeding QID, prognosis was guarded, and stated “... ST [speech therapy] referral for difficulty swallowing, coughing and clearing throat after swallowing clear fluids ....” The document failed to evidence the patient’s current g-tube feeding was Neosure 3 times daily, or the patient was NPO. During an interview on 12/01/2021 at 1:35 PM, when queried if the nurse ever instructed her not to allow the patient to have anything orally/by mouth, family stated “... No ....” When queried if the nurse ever witnesses her administering the g-tube feeding, she stated “... No, never ....” When queried if the nurse ever told her the patient had a 1500 ml daily fluid restriction, she indicated the nurse told her to call the doctor and find out. When queried if the nurse ever went over the patient’s medications with her, she stated “No.” When queried if the nurse provided teaching about medication administration via g-tube, she stated “No.” During an interview on 12/07/2021 at 1:54 PM, when queried if she would expect to see interventions for nutrition on the plan of care, administrator/RN A stated “Yes.” 6. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, primary diagnosis Alzheimer’s disease, unspecified, secondary diagnoses of dementia, repeated falls, essential (primary) hypertension (high blood pressure), type 2 (adult onset) diabetes, major depressive disorder, anxiety disorder (unspecified), long term (current) use of aspirin, and history of falling. Record review evidenced a document dated 08/20/2021, and signed by PT J on 08/30/2021, titled “... PT Start of Care ....” Record review indicated PT J did not review the patient’s medications, the patient was forgetful, was unable to take medications unless administered by someone else, was homebound due to Alzheimer’s with dementia, had poor endurance, was at high risk for falls and injury, and had impaired judgement with poor safety awareness. A document received from ALF Q on 12/06/2021, titled “... Order Review Report” indicated the patient’s current medications included AZO cranberry tablet (helps cleanse and protect the urinary tract), started on 12/09/2020, Xanax (anti-anxiety) 0.25mg (milligram) every 24 hours as needed for anxiety, started on 08/19/2020, and Zoloft (antidepressant) 50mg daily; and the patient was on a regular diet without restrictions. An agency document dated and signed by PT J on 08/30/2021, titled “Home Health Certification and Plan of Care” for certification period 08/20/2021 – 10/18/2021, indicated the patient was on a 2-gram sodium restricted and carbohydrate-controlled diet, medications included MAPAP (acetaminophen and an antihistamine) every 6 hours as needed (PRN), and ondansetron (prevents/reduces nausea and vomiting) every 6 hours as needed, and stated “... Risk for Hospitalization: ... Currently reports exhaustion ....” The plan of care failed to evidence indications for PRN medications MAPAP and ondansetron, or AZO cranberry tablet, Xanax, or Zoloft were included on the medication list on the plan of care, the correct diet (regular, unrestricted), patient specific interventions and/or training/education to address based on hospitalization risk of “currently reports exhaustion”, or the target audience for the teaching/education; psychosocial status included the patient resided at ALF Q, had impaired judgement with poor safety awareness, or cognitive status on current ability to comprehend and retain teaching. 7. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, primary diagnosis Alzheimer’s disease (unspecified), secondary diagnoses included dementia, repeated falls, major depressive disorder, anxiety disorder (unspecified), essential (primary) hypertension (high blood pressure), hyperlipidemia (high cholesterol (unspecified), hypothyroidism (unspecified), and history of falling. Record review evidenced a document dated 10/29/2021, signed by PT J on 11/02/2021, titled “... PT Start of Care ....” This document indicated the patient was unable to feed herself, was incontinent, needed supervision for safety, was confused, and unable to leave home alone. A document received from ALF Q on 11/18/2021, titled “... Order Review Report” indicated the patient’s diagnoses included edema, unspecified, delusional disorders, major depressive disorder, recurrent, moderate; medications included calazime skin protectant paste for excoriation to buttocks due to incontinence, cetirizine as needed for allergies, imodium as needed for diarrhea, Zoloft for depression, Zyprexa for delusional disorder, and the patient received a regular diet. An agency document signed by PT J on 11/02/2021, titled “Home Health Certification and Plan of Care” for certification period 10/29/2021 – 12/27/2021, indicated the patient was on a low sodium diet, was disoriented, activities permitted included the patient could be up as tolerated, use a walker, and perform exercises as prescribed; and risks for hospitalization included history of falls, currently was taking 5 or more medications, and currently reported exhaustion. The document failed to evidence the patient’s diagnoses of edema (unspecified), delusional disorders, major depressive disorder (recurrent, moderate); medications included calazime skin protectant paste, cetirizine, imodium, Zoloft, Zyprexa, or the patient was on a regular diet; patient specific interventions and/or training/education to address all hospitalization risks, risk of skin breakdown due to incontinence, or the target audience for the teaching/education; psychosocial status included the patient resided at ALF Q, needed supervision for safety, and was unable to leave home alone. 8. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, and a primary diagnosis type 2 (adult onset) diabetes with foot ulcer (open wound). Record review evidenced a document titled “Home Health Certification and Plan of Care”. This document indicated the patient had an indwelling foley catheter to be changed every 2 weeks and as needed, an 1800 calorie ADA (diabetic) diet, novolog insulin (anti-diabetic medication) to be injected before meals, and risks for hospitalization included multiple hospitalizations, decline in mental, emotional, or behavioral status in the past 3 months, reported or observed difficulty complying with any medical instructions, and currently took 5 or more medications. The document failed to evidence when the catheter was next due to be changed, indications for changing it “as needed”, interventions to ensure the patient adhered to an 1800 calorie ADA diet, how much insulin was to be injected before meals (sliding scale for administration), how often or who checked the patient’s blood sugar levels, or interventions to reduce risks of hospitalization; or the target audience for the teaching/education interventions. During an interview on 11/30/2021 at 3:00 PM, when queried if the plan of care evidenced when the catheter was last changed, or next time it was due to be changed, clinical manager B indicated it wasn’t. 9. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, primary diagnosis non-pressure chronic ulcer other part right lower leg with unspecified severity, secondary diagnoses of non-pressure chronic ulcer other part left lower leg with unspecified severity, chronic peripheral venous insufficiency (lack of blood flow to lower extremities), cardiomegaly (enlarged heart), and personal history of COVID-19 (04/27/2021). Record review evidenced a document titled “Home Health Certification and Plan of Care” for certification period 10/25/2021 – 12/23/2021. This document indicated the patient had a cardiac diet (a diet focused on reduction of sodium, fat and cholesterol intake), equipment included a walker and dressing supplies, mental status included the patient was depressed, and risks for hospitalization included history of falls, decline in mental, emotional, or behavioral status in the past 3 months, reported or observed difficulty complying with any medical instructions, currently taking 5 or more medications, currently reports exhaustion, and other risks not listed. The document failed to include equipment such as a rollator (wheeled) walker, a lift chair, shower, chair, and grab bars; interventions on reduction of fat and cholesterol intake, interventions to mitigate depression, patient specific interventions and/or training/education to address underlying risks for hospitalization, infection control to include COVID-19, or the target audience for the teaching/education. A home visit with patient #6 was observed on 11/19/2021 at 10:30 AM. The patient’s equipment included a rollator (wheeled) walker, a lift chair, shower chair, and grab bars. 10. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, and peripheral vascular disease (impaired lower extremity blood flow), indicated the patient regularly consumed alcohol, and the patient dug at their wounds with a coat hanger to relieve itching. An agency document titled “Home Health Certification and Plan of Care” for certification period 10/30/2021 – 12/28/2021, indicated the patient had a low sodium/low cholesterol diet, and medications included a nitro-dur patch daily. The document failed to evidence interventions for adherence to a low sodium/low cholesterol diet, instructions or precautions for the use of the nitro-dur patch, patient specific interventions and/or training/education to address diagnoses of heart failure, prevention of new and/or worsening skin breakdown, infection control to include COVID-19, interventions for the patient’s alcohol use, or the target audience for the teaching/education. During an interview on 12/07/2021 at 10:50 AM, when queried who was responsible for the patient’s wound care/management, administrator/RN A indicated the patient went to the wound clinic every week, then indicated the patient was an alcoholic. During this time, person A (corporate regulatory and resource specialist) asked if the patient was malnourished, and administrator/RN A stated “... probably ... there’s a lot of issues with her ... she sticks stuff down in her dressing and scratches her legs ....” When queried if her actions caused more wounds, administrator/RN A stated “... Sometimes yeah ... they got worse or got infected ....” When queried if the physician or wound clinic M was made aware of the alcoholism or the patient sticking coat hangers in her dressings and causing new or worsening wounds, administrator/RN A stated, “I don’t know.” When queried if the agency informed the wound clinic physician about the alcohol and coat hangers, administrator/RN A stated “... I don’t know ....” During this time, clinical manager B stated, “I just want to make sure it’s reflected that ... [patients #6 and 7 ] ... both go to wound clinic weekly ....” When queried if the alcohol use and scratching could have the potential to impact the plan of care, clinical manager B stated “Yes.” When queried if this information should be on the plan of care, clinical manager B stated “Yes.” When queried if the alcohol use could affect the efficacy of medications, administrator/RN A stated “Yes.” During an interview on 11/18/2021 at 11:00 AM, when queried where the patient’s psychosocial status could be found on the plan of care, administrator/RN A indicated it wasn’t on the plan of care unless they (clinicians) were addressing it. 11. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, primary diagnosis of unspecified open wound, right lower leg, subsequent encounter, secondary diagnoses of unspecified open wound, left lower leg, subsequent encounter, unspecified juvenile rheumatoid arthritis, essential (primary) hypertension (high blood pressure), adjustment disorder with depressed mood, hypothyroidism (unspecified), unspecified urinary incontinence, and history of falling. Record review evidenced a document titled “Home Health Certification and Plan of Care” for certification period 06/11/2021 – 08/09/2021. This document indicated the patient had a low sodium diet, and wound care was twice weekly and as needed. The document failed to evidence interventions for low sodium diet, indications for “as needed” wound care, interventions for hypertension, juvenile rheumatoid arthritis, adjustment disorder with depressed mood, hypothyroidism, urinary incontinence, or history of falling. 12. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood), permanent atrial fibrillation (irregular heart rhythm), dilated cardiomyopathy (weak heart muscle which causes inability to pump blood efficiently throughout the body), heart failure, end stage renal (kidney) disease, dependence on renal dialysis, major depressive disorder, and long term use of anticoagulants (blood thinners). Record review evidenced a document titled “Home Health Certification and Plan of Care” for certification period 04/30/2021 – 06/28/2021. This document indicated the patient’s diet was 2 gram sodium restricted, renal, and low carbohydrate, and medications included warfarin (a blood thinner which requires therapeutic blood monitoring); and failed to evidence interventions to monitor or ensure the patient adhered to a 2 gram sodium restricted, renal, and low carbohydrate diet, interventions to monitor therapeutic blood levels of warfarin, who managed the warfarin therapy, patient specific interventions and/or training/education to address infection control to include COVID-19, depression, or other diagnoses; or the target audience for the teaching/education. 13. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses of pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, and bed confinement status. Record review evidenced a document titled “Home Health Certification and Plan of Care” for certification period 11/07/2021 – 01/05/2022. This document indicated the patient took acetaminophen (tylenol) every 6 hours as needed for pain, the patient was anxious, and diet was renal, diabetic, and low sodium; evidenced an intervention to maintain a high protein diet to promote wound healing; and failed to evidence interventions to mitigate pain or anxiousness, prevention of new or worsening skin breakdown, teaching on renal/diabetic/low sodium diet, signs and symptoms, or prevention of UTI, infection control to include COVID-19, or the target audience for the teaching/education; patient’s psychosocial status included the need for 24 hour supervision due to bed confinement status and depended on others for all care; or cognitive status included the patient’s inability to comprehend or retain instruction/teaching. 14. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, certification dates 12/07/2021 – 02/04/2022, primary diagnosis pressure ulcer of sacral (lower back) region, unstageable, other diagnoses pressure ulcer of left buttock, unstageable, cellulitis of lower limb, unspecified dementia without behavioral disturbance, major depressive disorder, and dependence on wheelchair. Record review evidenced a document titled “Home Health Certification and Plan of Care” for certification period 12/07/2021 – 02/04/2022. This document indicated the patient was incontinent of bowel and bladder, skilled nursing was ordered twice weekly, and wound orders indicated dressings were to be changed 3 times weekly and as needed. The document failed to evidence supplies included incontinence briefs, indications for “as needed” wound care, who performed wound care when no agency staff present, patient specific interventions and/or training/education to address underlying risks for hospitalization, nutritional requirements to aide in wound healing, risk for falls, risk for new and/or worsening skin breakdown due to immobility and incontinence, decreased functional status, infection control to include COVID-19, or the target audience for the teaching/education; patient’s psychosocial status included the need for 24 hour supervision due to confusion and depended on others for all care; or cognitive status included the patient’s inability to comprehend or retain instruction/teaching. During an interview on 12/13/2021 at 11:15 AM, when queried about the patient’s ambulation status, administrator/RN A indicated the patient could not ambulate. When queried if the patient could transfer herself, she indicated the patient couldn’t, and ALF people did it. When queried if there was any concern that the patient may be too acute to reside at an ALF, she stated “... Ya, possibly ... I’ve only seen her one time ... but they had to help me get her to bed ... not a good memory ... can’t transfer herself ....” When queried who was instructed (for teaching interventions on the plan of care), she indicated teaching was directed to the patient, ALF staff, and family. When queried if there should be interventions for incontinence or ambulatory status, she stated “Yes.” 15. During an interview on 11/18/2021 at 11:00 AM, when queried where patients’ cognitive and psychosocial statuses were located on the plan of care, administrator/RN A indicated they weren’t included on the plan of care unless there was an issue, and they (the agency) were addressing it. When queried if patient preferences and patient’s goals should be on the plan of care, administrator/RN A indicated yes, they were supposed to be. When queried if goals should be based on the patient’s diagnoses, she stated “Yes.” When queried if the plan of care should be individualized, she stated “Yes.” 16. During an interview on 12/7/2021 at 1:54 PM, when queried about the required contents of the plans of care, administrator/RN A stated “... If all this stuff was on the plan of care, it would be like 7 pages long ....” 17-13-1(a)(1)(B) 17-13-1(a)(1)(C ) 17-13-1(a)(1)(D)(ii, iv, vi, vii, viii, ix, x, xiii)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the clinician promptly notified the patient’s physician or family nurse practitioner (FNP) for 6 of 7 records reviewed with patients who experienced a significant change in physical and/or psychosocial condition which required medical intervention(s) (#1, 2, 7, 8, 9, 10). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Physician Participation in the Plan of Care ....” stated “... A physician will direct the care of every home health patient admitted for service .... will participate ... by initiating, reviewing and revising therapeutic and diagnostic orders ... will be reviewed and revised by the patient’s physician ... based on ... Changes in the care ... Changes in the patient’s physical and psychosocial condition ... response to care ... medications ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Ongoing Assessments ....” stated “... Based on the findings ... change/verbal orders will be generated and forwarded to the physician ... as needed ... physician will be notified to verify any changes in medications, including over-the-counter ... and treatments/interventions ....” 3. Record review for patient #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, primary diagnosis stage 2 pressure ulcer (wound caused by unrelieved pressure, no deeper than all layers of the skin, and includes intact or ruptured blisters) of left buttock, and other pertinent diagnosis stage 2 pressure ulcer of right buttock. Record review evidenced a comprehensive assessment dated and signed by RN (registered nurse) G on 10/29/2021, titled “... Recertification ....”, which indicated the patient resided at ALF (assisted living facility) Q (based on documented address), was at risk for development of pressure sores, had a stage 2 pressure sore on the right (R) buttock, a "healed" pressure sore to the left (L) buttock, An agency document dated and signed by licensed practical nurse (LPN) H on 11/02/2021, titled “... SN [skilled nurse] Visit Note” indicated the (R) buttock wound was scabbed, the (L) buttock wound bed was now gray, and failed to evidence LPN H notified the physician of the change in the patient’s condition. An agency document dated and signed by LPN H on 11/9/2021, titled “... SN Visit Note” indicated the (R) buttock wound was healed, the (L) buttock wound bed was then black, and was greater in size from previous visit, the patient complained of pain with sitting and during wound care, and failed to evidence LPN H notified the physician of the change in the patient’s condition. During an interview on 11/30/2021 at 1:30 PM, when queried if the SN visit on 11/09/2021 evidenced LPN H notified the physician of the change in the patient’s condition, clinical manager B indicated it evidenced LPN H reported the change to staff at ALF Q. 4. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021. The record evidenced a primary diagnosis of dysphagia, pharyngeal phase (decreased ability during swallowing to pass food from the throat to the stomach, with risk of overflow of lodged food, medications, or fluids leaking into the lungs); other pertinent diagnoses of insertion of feeding tube (g tube- tube inserted from the abdomen into the stomach for administration of nutritional supplements/feedings, fluids, and medications) was inserted on 9/21/2021. The agency document dated and signed by RN I on 9/30/2021, titled “... SN Visit Note” indicated the patient complained of nausea/vomiting, and failed to evidence the nurse notified the physician of the change in the patient’s condition. 5. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, primary diagnosis chronic obstructive pulmonary disease (lung disease), hypertensive heart disease with heart failure (high blood pressure with decreased ability of the heart to pump blood throughout the body), non-pressure chronic ulcer (wound) of other part of left lower leg with unspecified severity, peripheral vascular disease (impaired lower extremity blood flow) and dependence on supplemental oxygen. Record review evidenced a comprehensive assessment dated and signed by RN G on 10/26/2021, titled “... Recertification ....” This document indicated 2 wounds: a stasis ulcer (L) leg, black wound bed, (4.0 cm x 3.0 cm x 0.3 cm), no odor; and an open wound (L) leg, pale pink wound bed, (2.1 cm x 1.6 cm x 0.3 cm) small amount serosanguinous drainage, no evidence of infection documented, assisted living facility (ALF) L was not permitted to perform wound care, pain rated by patient as “8” [on a scale of 0 – 10, with 0 being no pain and 10 the most severe] in (L) leg, and stated “... numeric [pain] scale ... 0: None ... 7-9: requires MD [physician] intervention ....” The document failed to evidence the nurse notified the physician for the patient’s pain reported as “8”. An agency document dated and signed by LPN E on 11/03/2021, titled “... SN Visit Note” stated “... It was brought to the attention of this author [LPN E] today ... patient is consuming 4 to 5 beers a day ....” The document failed to evidence the nurse notified the physician of the patient’s psychosocial status. A hospital D document dated 11/04/2021, titled “History and Physical Reports” indicated the patient was admitted on 11/03/2021, and discharged on 11/08/2021. Record review indicated the patient complained of increased pain, redness and swelling to (L) lower leg, which spread up back of leg, for 2 days; and was admitted with cellulitis which required treatment with intravenous (IV) antibiotics. The document also indicated the patient was a current daily beer drinker. An agency document dated and signed by administrator/RN A on 11/09/2021, titled “... Resumption of Care ....” stated “... Patient has been found with a lot of beer in her room and has become a concern to facility ....” The document failed to evidence the physician was notified of the patient’s psychosocial status. An agency document dated and signed by LPN E on 11/15/2021, titled “... SN Visit Note” evidenced the patient rated pain at “8”, wounds were painful to touch, patient squirmed during care, which made wound care difficult to perform, ALF L staff reported patient was consuming alcoholic beverages, and patient was verbally abusive to LPN E during the visit, and ALF L staff reported the alcoholic beverages caused the patient to become irritated and angry. The document failed to evidence the physician was notified of the patient’s pain or psychosocial status. During an interview on 12/07/2021 at 10:50 AM, when queried who was responsible for the patient’s wound care/management, administrator/RN A indicated the patient went to the wound clinic every week, asked the surveyor if the wound was their (agency) responsibility, indicated they (agency) followed wound care orders, and asked again if they (agency) were supposed to be responsible. When queried if a wound could deteriorate in less than a week, clinical manager B stated “Yes, a wound can deteriorate in less than a week.” Administrator/RN A then indicated LPN E sent the patient to the hospital for the worsening wound, and indicated the agency couldn’t control everything or they’d be “God”, they saw the patient twice weekly, and if it worsened, they sent her to the hospital, and also indicated the patient was an alcoholic. During this time, person A (corporate regulatory and resource specialist) asked if the patient was malnourished, and administrator/RN A stated “... probably ... there’s a lot of issues with her ... she sticks stuff down in her dressing and scratches her legs ....” When queried if her actions caused more wounds, administrator/RN A stated “... Sometimes yeah ... they got worse or got infected ....” When queried if the physician or wound clinic M was made aware of the alcoholism or the patient sticking coat hangers in her dressings and causing new or worsening wounds, administrator/RN A stated, “I don’t know.” During this time, clinical manager B stated, “I just want to make sure it’s reflected that ... [patients #6 and 7 ] ... both go to wound clinic weekly ....” When queried if the alcohol use and scratching could have the potential to impact the plan of care, clinical manager B stated “Yes.” When queried if this information should be on the plan of care, clinical manager B stated “Yes.” When queried if the alcohol use could affect the efficacy of medications, administrator/RN A stated “Yes.” During an interview on 11/18/2021 at 11:00 AM, when queried where the patient’s psychosocial status could be found on the plan of care, administrator/RN A indicated it wasn’t on the plan of care unless they (clinicians) were addressing it. 6. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, and primary diagnosis unspecified open wound, right lower leg. An agency document dated and signed by LPN H on 07/02/2021, titled “... SN Visit Note” stated “... New Wound to L [left] posterior calf ....” The document failed to evidence the physician was notified of the change in the patient’s condition. An agency document dated and signed by LPN H on 07/16/2021, titled “... SN Visit Note” indicated the patient experienced a fall resulting in an injury and was seen in the ED (unknown date). The document indicated the patient sustained severe skin tears to the right wrist, right elbow, 2 skin tears to the right shin, a skin tear to the right calf, and the left posterior calf wound was ongoing; and also indicated the patient sustained ecchymosis (bleeding under the skin/bruising) to the right forehead and eye socket, and the patient could not remember how the skin tears occurred. The document stated “... Observed to use scooter [motorized wheelchair] unsafely ... endangering patient and others around him ... manual wheelchair would be safer ... Patient admitted that ‘sometimes I scare myself’ ....” and failed to evidence the physician was notified of the change in the patient’s condition. During an interview on 12/13/2021 at 2:36 PM, when queried if the physician was notified for the patient’s refusal of PT, clinical manager B stated “... Don’t see it ....” When queried about the patient’s continual falls, and if the agency completed fall reports, clinical manager B indicated the agency didn’t complete fall reports for patients in ALFs, the ALF did it. When queried if the physician was notified, clinical manager B declined to answer. When queried if coordination with the physician occurred about the ED visit, clinical manager B indicated there was not. 7. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, primary diagnosis COVID-19, other diagnoses included pneumonia due to COVID-19, acute respiratory failure with hypoxia (abnormally low concentration of oxygen in the blood), permanent atrial fibrillation (irregular heart rhythm), dilated cardiomyopathy (weak heart muscle which causes inability to pump blood efficiently throughout the body), heart failure, end stage renal (kidney) disease, dependence on renal dialysis, major depressive disorder, and long term use of anticoagulants (blood thinners). Record review evidenced a document dated and signed by administrator/RN A on 04/30/2021, titled “... Start of Care ....” which indicated the patient became short of breath when walking more than 20 feet or climbing stairs, the patient’s respirations were unlabored, and the patient’s oxygen (O2) saturation was 97% (percent) (normal values are 95-100%). An agency document dated and signed by contracted PT AA on 05/03/2021, titled “Physical Therapy Evaluation ... Initial Evaluation” stated “... Patient has poor endurance and confused. Unable to obtain SaO2 [O2 saturation] levels d/t [due to] not registering on device ....” The document failed to evidence the physician was notified, or PT AA assessed the patient’s lung sounds or capillary refill (time required for return of color after application of pressure to the fingernail/toenail bed, to indicate oxygenation of blood). A document titled “Home Health Certification and Plan of Care” for certification period 04/30/2021 – 06/28/2021 stated “... Clinician to report pulse oximetry [oxygen saturation] below 90 [%] to physician ....” An agency document dated and signed by LPN H on 05/04/2021, titled “... SN Visit Note” stated “... Patient fearful of author leaving, saying she wouldn’t be alive tomorrow ... Patient saw MD today ... Unable to obtain sufficient blood for INR [blood test to determine therapeutic levels of blood thinner] ... Planned return visit 5/5/21 for another attempt ... Glimepiride [medication to treat high blood sugar levels] ordered by primary MD for severely elevated BS [blood sugar] ... BS extremely lowered by same, which [family member] was to give for BS > [greater than] 200. After giving same ... patient’s BS 45, then 38, then 53, despite feeding the patient. Per [family member], given Glucagon [emergency medical treatment medication to treat very low blood sugar] at MD visit today ... Patient lethargic through most of SNV [SN visit] ... anxious, saying she could not breathe ... saying she was dying ....” The document failed to evidence the nurse contacted the physician for the change in the patient’s condition. During an interview on 12/13/2021 at 2:15 PM, when queried if the record evidenced the physician was contacted, clinical manager B indicated it didn’t. 8. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, primary diagnosis cutaneous abscess of buttock (a localized collection of pus in the skin, and treatment is incision and drainage), secondary diagnoses of pressure ulcer of right buttock, stage 3 (full-thickness skin loss potentially extending into the subcutaneous/fatty tissue layer), pressure ulcer of left buttock, unstageable (an ulcer that has full thickness tissue loss but is either covered by extensive necrotic/dead tissue or by slough/fibrous dead tissue), urinary tract infection (UTI), paraplegia (paralysis of the legs and lower body), hypertensive heart and chronic kidney disease with heart failure, diabetes, dependence on kidney dialysis, and bed confinement status. Record review evidenced a document dated 11/08/2021, (not signed) by RN I, which stated “... Family is also discussing placement at skilled nursing facility ....” and failed to evidence the physician was notified of the family’s psychosocial status. An agency document dated 11/09/2021, (not signed) by RN I, titled “... SN Visit Note” stated “... family is overwhelmed with her care ....” , and failed to evidence the physician was notified of the family’s psychosocial status. An agency document dated 11/15/2021, titled “... Transferred to an Inpatient Facility ....” was initiated by RN I, but the document was incomplete, unsigned by the nurse, and failed to evidence the date or reason the patient was admitted, or the physician was notified of the change in the patient’s condition. 9. During an interview on 11/19/2021 at 1:00 PM, when asked to describe the agency’s process for a new or worsening change in patient condition, administrator/RN A indicated she would inform the RN case manager, other team members, the physician, and write an order if needed. 17-13-1(a)(2)

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all patients received written information of the name and contact information of the clinical manager for 6 of 6 home visits observed (#1, 2, 4, 6, 7, 11). Findings include: 1. A home visit was observed with patient #1 on 11/18/2021 at 9:00 AM. Review of the patient’s home folder failed to evidence written information for the name and contact information of the agency’s clinical manager. 2. A home visit was observed with patient #2 on 11/18/2021 at 12:55 PM. Review of the patient’s home folder failed to evidence written information for the name and contact information of the agency’s clinical manager. 3. A home visit was observed with patient #4 on 11/18/2021 at 9:45 AM. Review of the patient’s home folder failed to evidence written information for the name and contact information of the agency’s clinical manager. 4. A home visit was observed with patient #6 on 11/19/2021 at 10:30 AM. Review of the patient’s home folder failed to evidence written information for the name and contact information of the agency’s clinical manager. 5. A home visit was observed with patient #7 on 11/22/2021 at 10:30 AM. Review of the patient’s home folder failed to evidence written information for the name and contact information of the agency’s clinical manager. 6. A home visit was observed with patient #11 on 12/15/2021 at 10:06 AM. Review of the patient’s home folder failed to evidence written information for the name and contact information of the agency’s clinical manager. 7. During an interview on 11/17/2021 at 3:15 PM, the agency’s admission packet was reviewed with administrator/registered nurse (RN) A, clinical manager B, and person A (corporate regulatory and resource specialist). During this time, administrator/RN A indicated all patients received this packet upon admission for home health services. When queried if the name and contact information for the agency’s clinical manager was included in the agency’s admission packet documents, clinical manager B indicated it was not.

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on record review and interview, the home health agency failed to evidence it implemented, evaluated, and maintained an effective, ongoing, agency-wide, data-driven quality assessment and performance improvement (QAPI) program that concentrated on infection control issues and adverse events (See tag G642); failed to evidence it collected and utilized agency specific data to monitor the effectiveness and safety of services and quality of care provided by the agency, identified opportunities for improvement, or the agency’s governing body approved the frequency and detail of the data collection (See tag G644); failed to evidenced it focused on high risk, high volume, or problem-prone areas (See tag G648); failed to address the prevalence and severity of problems (See tag G650); failed to evidence it implemented immediate correction of any identified problems that directly or potentially threatened the health and/or safety of patients (See tag G652); failed to evidence it implemented any actions aimed at performance improvement (See tag G656); failed to evidence it conducted and documented performance improvement projects (PIPs) (See tag G658); and failed to evidence the governing body ensured the agency’s QAPI program was developed, implemented and maintained, or ensured a suspected finding of fraud was appropriately addressed (See tag G660). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment for the Condition of Participation 42 CFR §484.65: Quality Assessment and Performance Improvement (QAPI). 17-12-2(a)

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to implement, evaluate, and maintain an effective, ongoing, agency-wide, data-driven quality assessment and performance improvement (QAPI) program that concentrated on infection control issues and adverse events. Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2015, titled “Organizational Planning” stated “... To define a process for the development and monitoring of an organizational/strategic plan ... consistent with ... patient needs ... [agency] leaders will be responsible for developing and implementing ... planning process includes ... data needed to measure the performance of the processes and outcomes of care and services ... Results of organization quality assessment performance improvement activities ... written strategic plan will be developed and approved by the Governing Body at least every three (3) years ... Changes ... will be incorporated into the planning document as addenda ... planning process will be monitored by leadership through a quarterly review of ... Quality Assessment Performance improvement results ... Minutes of the management meetings and other committees, as well as minutes from the Governing Body and appropriate oversight committees ... will reflect the planning process ....” An agency job description, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Executive Director/Administrator” stated “... Responsible for planning, coordinating, managing, and directing all activities and programs of the At Home Quality Care [agency] ... Directing and monitoring organizational performance improvement activities ... A World Health Organization (WHO) web-base reference dated 09/13/2019, titled “Patient Safety” was reviewed on 12/14/2021, which stated “... The occurrence of adverse events due to unsafe care is likely one of the 10 leading causes of death and disability in the world ... Globally, as many as 4 in 10 patients are harmed in primary and outpatient health care. Up to 80% of harm is preventable ... Patient Safety ... aims to prevent and reduce risks, errors and harm that occur to patients during provision of health care. A cornerstone of the discipline is continuous improvement based on learning from errors and adverse events ... To ensure successful implementation of patient safety strategies ... clear policies, leadership capacity, data to drive safety improvements, skilled health care professionals and effective involvement of patients in their care, are all needed ....” During an interview on 11/18/2021 at 11:00 AM, with administrator/RN A, when queried when the last QAPI meeting was conducted, she indicated it had been a while, and she didn’t know. When queried who attended the meeting, she indicated she didn’t know. When queried who ran the QAPI program/meetings, she indicated she did, but licensed practical nurse (LPN) E did a lot of it. During an interview on 12/14/2021 at 11:14 AM, administrator/RN A, clinical manager B, and person A (corporate regulatory and resource specialist) were present, and a QAPI Binder was submitted for review, titled “QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home”, which failed to evidence any agency specific data, information, or documentation, including COVID-19 tracking information for patients or staff. When queried to describe the binder, and its function within the agency, clinical manager B indicated there was no agency specific data in the binder, and person A indicated it was what (they) were going to start teaching administrator/RN A about. When queried, administrator/RN A stated “... I am in charge of QAPI ....” An additional binder was submitted for review titled “QAPI 2018”, which included Centers for Medicare and Medicaid Services agency reports requested on 11/23/2021, for date ranges 09/2019 – 08/2021. When queried to describe the findings of the reports, administrator/RN A indicated the reports targeted what (we) need to work on, (we) work toward that goal, but failed to indicate what the agency needed to work on. When queried if there was any data in the binder to support the target(s), administrator/RN A stated “... No, I guess not ... QAPI for COVID is in the EP [emergency preparedness] binder ....” During this time, clinical manager B and person A both indicated the QAPI program was not current, not agency specific, identified areas of concern (hospitalizations/re-hospitalizations and urinary tract infections), but contained no data content, action taken, or follow up. During an interview on 12/14/2021 at 11:14 AM, when queried to describe her involvement with the emergency preparedness program, administrator/RN A stated “... Somewhat ... we [herself, clinical manager B, and person A] talk about it ....” During this time, person A indicated the emergency preparedness program needed to be completely re-vamped, and administrator/RN A and clinical manager B both indicated the agency’s emergency preparedness program was not current and did not reflect the needs of this agency. During an interview on 12/14/2021 at 11:51 AM, clinical manager B indicated the agency had a lot of growth within the last 60 days, the agency would stop admitting new patients until (they) get this pulled together, and stated “... I know that you [surveyor] reviewed charts that had patients hospitalized ... but no one can be sure that it was our fault ... we have been working on this for a long time ....” When queried what the agency did to address the concern with hospitalizations, clinical manager B stated “... It’s not written down and no sign in sheet, but we have educated the staff ... I know re-hospitalization in Indiana is 15% and ours is 19% ....” When queried when the agency obtained the hospitalization data, clinical manager B stated “... Whenever the last quality scores came out ... like within the last 6 months, I think ... It’s always our focus ... we need to improve in some areas, our intention is for patients to do well ... All these old people fall ... We have never ever done fall reports for patients who fall in facilities ... I don’t want you [surveyor] to think we’re being negligent ....” 17-12-2(a)

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to evidence it collected and utilized agency specific data to monitor the effectiveness and safety of services and quality of care provided by the agency, identify opportunities for improvement, or the agency’s governing body approved the frequency and detail of the data collection for the agency’s quality assessment performance improvement (QAPI) program. Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2015, titled “Organizational Planning” stated “... To define a process for the development and monitoring of an organizational/strategic plan ... consistent with ... patient needs ... [agency] leaders will be responsible for developing and implementing ... planning process includes ... data needed to measure the performance of the processes and outcomes of care and services ... Results of organization quality assessment performance improvement activities ... written strategic plan will be developed and approved by the Governing Body at least every three (3) years ... Changes ... will be incorporated into the planning document as addenda ... planning process will be monitored by leadership through a quarterly review of ... Quality Assessment Performance improvement results ... Minutes of the management meetings and other committees, as well as minutes from the Governing Body and appropriate oversight committees ... will reflect the planning process ....” During an interview on 12/14/2021 at 11:14 AM, administrator/registered nurse (RN) A, clinical manager B, and person A (corporate regulatory and resource specialist) were present, and a QAPI Binder was submitted for review, titled “QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home”, which failed to evidence any agency specific data, information, or documentation. An additional binder was submitted for review titled “QAPI 2018”, which included Centers for Medicare and Medicaid Services agency reports requested on 11/23/2021, for date ranges 09/2019 – 08/2021. When queried to describe the findings of the reports, administrator/RN A indicated the reports targeted what (we) need to work on, and (we) work toward that goal. When queried if there was any data in the binder to support the target(s), administrator/RN A stated “... No, I guess not ... QAPI for COVID is in the EP [emergency preparedness] binder ....” During this time, clinical manager B and person A both indicated the QAPI program was not current, not agency specific, identified areas of concern (hospitalizations/re-hospitalizations and urinary tract infections), but contained no data content, action taken, or follow up. During an interview on 12/14/2021 at 11:51 AM, clinical manager B indicated the agency had a lot of growth within the last 60 days, the agency would stop admitting new patients until (they) get this pulled together, and stated “... I know that you [surveyor] reviewed charts that had patients hospitalized ... but no one can be sure that it was our fault ... we have been working on this for a long time ....” When queried what the agency did to address the concern with hospitalizations, clinical manager B stated “... It’s not written down and no sign in sheet, but we have educated the staff ... I know re-hospitalization in Indiana is 15% and ours is 19% ....” When queried when the agency obtained the hospitalization data, clinical manager B stated “... Whenever the last quality scores came out ... like within the last 6 months, I think ... It’s always our focus ... we need to improve in some areas, our intention is for patients to do well ... All these old people fall ... We have never ever done fall reports for patients who fall in facilities ... I don’t want you [surveyor] to think we’re being negligent ....” During an interview on 11/17/2021 at 3:50 PM, surveyor requested all governing body meeting minutes from 2018 to present. Upon survey exit, nothing further was submitted. 17-12-2(a)

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to evidence it focused on high risk, high volume, or problem-prone areas for the agency’s quality assessment performance improvement (QAPI) program. Findings include: An untitled document dated 12/16/2021 with agency letterhead stated “... Per your request for patient census data ... August 2021 = 66 ... September 2021 = 77 ... October 2021 = 77 ... November 2021 = 93 ... As of December 15, 2021 = 104.” During an interview on 12/14/2021 at 11:14 AM, administrator/ registered nurse (RN) A, clinical manager B, and corporate regulatory and resource specialist A were present, and a QAPI Binder was submitted for review, titled “QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home”, which failed to evidence any agency specific data, information, or documentation. An additional binder was submitted for review titled “QAPI 2018”, which included Centers for Medicare and Medicaid Services agency reports requested on 11/23/2021, for date ranges 09/2019 – 08/2021. When queried to describe the findings of the reports, administrator/RN A indicated the reports targeted what (we) need to work on, and (we) work toward that goal. When queried if there was any data in the binder to support the target(s), administrator/RN A stated “... No, I guess not ....” During this time, clinical manager B and corporate regulatory and resource specialist A both indicated the QAPI program was not current, not agency specific, identified areas of concern (hospitalizations/re-hospitalizations and urinary tract infections), but contained no data content, action taken, or follow up. During an interview on 12/14/2021 at 11:51 AM, clinical manager B indicated the agency had a lot of patients, (census) growth occurred within the last 60 days, charts evidenced patients were hospitalized, but no one could be sure that it was the agency’s fault. When queried what actions the agency took to address it, clinical manager B indicated it wasn’t written down, but they did educate staff. She also indicated she knew re-hospitalization in Indiana was 15% and the agency was 19%. When queried when the agency obtained the hospitalization data, clinical manager B stated “... Whenever the last quality scores came out ... like within the last 6 months, I think ... It’s always our focus ... we need to improve in some areas, our intention is for patients to do well ... All these old people fall ....” During this time, administrator/RN A stated “... It’s not that we’re not going over and above ... we may not document everything ....”

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to address the prevalence of wounds for the agency’s quality assessment performance improvement (QAPI) program. Findings include: An Indiana Department of Health (IDOH) form titled “Facility Census-Home Health ....” evidenced the agency had 106 active patients as of 11/17/2021. An untitled document received on 11/17/2021 at 11:14 AM evidenced 18 patients had wounds (17% of total census). An untitled document dated 12/16/2021 with agency letterhead stated “... Per your request for patient census data ... As of December 15, 2021 = 104.” During an interview on 12/7/2021 at 1:15 PM, administrator/ registered nurse (RN) A indicated the agency had 26 patients with wounds (25% of total census). During an interview on 12/14/2021 at 11:14 AM, clinical manager B and person A (corporate regulatory and resource specialist) both indicated the QAPI program was not current, not agency specific, and contained no data, action taken, or follow up.

Activities lead to an immediate correction CFR(s): 484.65(c)(1)(iii) (iii) Lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to evidence it implemented immediate corrective action(s) for new/worsening wounds or hospitalization/re-hospitalizations that directly or potentially threatened the health and/or safety of patients in the agency’s quality assessment performance improvement (QAPI) program. Findings include: During an interview on 12/14/2021 at 11:14 AM, administrator/ registered nurse (RN) A, clinical manager B, and corporate regulatory and resource specialist A were present, and a QAPI Binder was submitted for review, titled “QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home”, which failed to evidence any agency specific data, information, or documentation. An additional binder was submitted for review titled “QAPI 2018”, which included Centers for Medicare and Medicaid Services agency reports requested on 11/23/2021, for date ranges 09/2019 – 08/2021. When queried to describe the findings of the reports, administrator/RN A indicated the reports targeted what (we) need to work on, and (we) work toward that goal. When queried if there was any data in the binder to support the target(s), administrator/RN A stated “... No, I guess not ....” During this time, clinical manager B and person A (corporate regulatory and resource specialist) both indicated the QAPI program was not current, not agency specific, identified areas of concern (hospitalizations/re-hospitalizations and urinary tract infections), but contained no data content, action taken, or follow up. During an interview on 12/14/2021 at 11:51 AM, clinical manager B stated “... I know that you [surveyor] reviewed charts that had patients hospitalized ... but no one can be sure that it was our fault ... we have been working on this for a long time ....” When queried what the agency did to address the concern with hospitalizations, clinical manager B stated “... It’s not written down and no sign in sheet, but we have educated the staff ... I know re-hospitalization in Indiana is 15% and ours is 19% ....” When queried when the agency obtained the hospitalization data, clinical manager B stated “... Whenever the last quality scores came out ... like within the last 6 months, I think ... It’s always our focus ... we need to improve in some areas, our intention is for patients to do well ... All these old people fall ... We have never ever done fall reports for patients who fall in facilities ... I don’t want you [surveyor] to think we’re being negligent ....” 17-12-2(a)

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to evidence it implemented any actions aimed at performance improvement for the agency’s quality assessment performance improvement (QAPI) program. Findings include: During an interview on 12/14/2021 at 11:14 AM, administrator/ registered nurse (RN) A, clinical manager B, and corporate regulatory and resource specialist A were present, and a QAPI Binder was submitted for review, titled “QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home”, which failed to evidence any agency specific data, information, or documentation. An additional binder was submitted for review titled “QAPI 2018”, which included Centers for Medicare and Medicaid Services agency reports requested on 11/23/2021, for date ranges 09/2019 – 08/2021. When queried to describe the findings of the reports, administrator/RN A indicated the reports targeted what (we) need to work on, and (we) work toward that goal. When queried if there was any data in the binder to support the target(s), administrator/RN A stated “... No, I guess not ....” During this time, clinical manager B and person A (corporate regulatory and resource specialist) both indicated the QAPI program was not current, not agency specific, identified areas of concern (hospitalizations/re-hospitalizations and urinary tract infections), but contained no data content, action taken, or follow up. 17-12-2(a)

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to evidence it conducted and documented performance improvement projects (PIPs) for the agency’s quality assessment performance improvement (QAPI) program. Findings include: During an interview on 11/18/2021 at 11:00 AM, when queried to describe the agency’s current PIPs, administrator/ registered nurse (RN) A indicated COVID-19 and infection. During an interview on 11/30/2021 at 12:30 PM, when queried if the agency had an infection control program, clinical manager B stated “... Yes ... So, certainly the focus has been COVID ... we do document when patients do have infection upon admission, or develop one ... we have a report ....” When queried where the documentation was located, she stated “... I think it’s here in this office [agency] ....”, and indicated administrator/RN A was responsible for the infection control program. During this time, the surveyor requested all documentation related to the agency’s infection control program, a policy was submitted, but no other documents related to PIPs was received upon exit. When queried how findings of the infection control program were relayed to staff, clinical manager B failed to respond. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2015, titled “Infection Control Plan” was received on 11/30/2021 at 12:50 PM, which failed to evidence COVID-19 was addressed.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the governing body ensured the agency’s QAPI program was developed, implemented, and maintained. Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2015, titled “Governing Body” stated “... The Governing Body will assume full legal authority, responsibility, and accountability for the operation of At Home Quality Care ... will establish policies ... and approve new or revised policies as needed ... Relevant findings of performance improvement activities are consistently provided to the Governing Body ....” During an interview on 12/14/2021 at 11:14 AM, administrator/ registered nurse (RN) A, clinical manager B, and person A (corporate regulatory and resource specialist) were present, and a QAPI Binder was submitted for review, titled “QAPI at a Glance: A Step by Step Guide to Implementing Quality Assurance and Performance Improvement (QAPI) in Your Nursing Home”, which failed to evidence any agency specific data, information, or documentation. An additional binder was also submitted for review titled “QAPI 2018”, which included Centers for Medicare and Medicaid Services agency reports requested on 11/23/2021, for date ranges 09/2019 – 08/2021. When queried to describe the findings of the reports, administrator/RN A indicated the reports targeted what (we) need to work on, and (we) work toward that goal. When queried if there was any data in the binder to support the target(s), administrator/RN A stated “... No, I guess not ....” During this time, clinical manager B and person A both indicated the QAPI program was not current, not agency specific, and failed to evidence agency specific data content, action taken, or follow up.

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 observation, record review and interview, the agency failed to ensure all agency employees provided quality health care services in a safe environment for its patients, which resulted in the citing of an immediate jeopardy (IJ) on 12/06/2021 (See G510, G570); ensured the patients’ rights were upheld (See G406); ensured an effective discharge planning process was developed and implemented (See G560); ensured an agency-wide, data-driven quality assessment and performance improvement (QAPI) program was implemented, evaluated, and maintained (See G640); ensured information contained in the patients’ clinical records was accurate, and adhered to current clinical record documentation standards of practice (See G1008); and ensured a comprehensive emergency preparedness program was developed, implemented, and maintained, based on the geographic location and patient population served (See E0001); Also, the agency failed to ensure the agency’s operational policies were revised, implemented, and included the Centers for Medicare and Medicaid’s revised regulations, titled “ State Operations Manual ... Appendix B - Guidance to Surveyors: Home Health Agencies”, implemented 09/28/2018, and additional regulations implemented on 02/21/2020; ensured all agency personnel had access to agency policies at all times; ensured the responsibilities of the governing body, administrator, and clinical manager were not delegated to another organization or other person(s) on an on-going basis; and ensured agency lines of authority for the delegation of responsibility were clearly identifiable and readily available (See G942); the administrator reported directly to the Governing Body (See G946); and the administrator failed to be responsible for the day to day functions of the agency (See G948); and failed to ensure the registered nurse contacted the patient’s physician(s) to verify and/or obtain order(s) for medications a family reported he/she administered to the patient, instructed a family member to administer medication(s) to the patient without first verifying and/or obtaining orders from the physician(s); failed to contact the physician and/or provide a skilled nursing assessment for a reported significant change in the patient’s condition; instructed a family member to contact the physician him/herself to report signs/symptoms of a significant change in condition, and instructed a family member to contact the physician him/herself to request medication(s) related to new onset signs/symptoms (See G984). This practice had the potential to affect all agency patients. 17-12-1(b) 17-12-1(b)(1) Additionally: 1. IDOH (Indiana Department of Health) has no reciprocal agreements with surrounding states for the home health program. 2. During an interview on 11/17/2021 at 10:42 AM, when queried the names of the administrator, alternate administrator, clinical manager and alternate clinical manager, administrator/RN (registered nurse) A indicated she was the administrator and clinical manager, and clinical manager B was the alternate administrator and alternate clinical manager, and clinical manager B was “corporate”. When queried if the agency had additional locations, including branches, administrator/RN A indicated the “home” office was in Oak Forest (a separate licensed home care agency in Illinois owned by the same corporation), and agency being surveyed was a branch of the Oak Forest agency. 3. During an interview on 11/17/2021 at 3:30 PM, a second request was made for the agency’s drug screen policy, which was submitted at 3:40 PM, by person A (corporate regulatory and resource specialist, not an agency employee), titled “... Orientation ....” When queried if the if the policy evidenced when it was created, revised, approved, or who revised it, clinical manager B indicated she did not have that documentation here at this office, and they had to get it from the governing body. During this time, clinical manager B indicated she emailed to request a “policy approval document”. When queried who she emailed, clinical manager B stated “... Another branch ....” When queried which branch, she stated "Oak Forest", and indicated she was the vice president of operations, she and person A could revise policies, but administrator/RN (registered nurse) A couldn’t. When queried why the agency’s administrator couldn’t revise policies, person A indicated they (corporation) had a lot of facilities (home care agencies), administrator/RN A had "read only" access to policies, and stated “... otherwise, we'd have people changing these policies left and right ....” 4. During an interview on 11/18/2021 at 9:45 AM, when queried who administrator/RN A reported to, LPN (licensed practical nurse) H indicated she reported to clinical manager B, the main office was in Illinois, clinical manager B was from the Illinois office, and she oversaw all of the offices. 5. During an interview on 11/19/2021 at 10:30 AM, when queried who the administrator was, LPN E indicated clinical manager B was, because that’s who administrator/RN A answered to, clinical manager B was above administrator/RN A, and this agency was a branch of the Illinois office. 6. During an interview on 11/30/2021 at 12:30 PM, when queried if she worked another job, or at another location, clinical manager B indicated she lived in Illinois, did not have another job, and she worked for the corporation. The cumulative effect of this systemic problem resulted in the agency being out of compliance with the Condition of Participation 42 CFR §484.105 Organization and Administration of Services.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on record review and interview, the governing body failed to ensure the agency’s operational policies were revised and implemented; ensured all agency personnel had access to agency policies at all times; ensured the responsibilities of the governing body, administrator, and clinical manager were not delegated to another organization or other person(s) on an on-going basis; and ensured agency lines of authority for the delegation of responsibility were clearly identifiable and readily available. Findings include: An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2015, titled “... Governing Body ....” stated “... Governing Body ... will assume full legal authority, responsibility and accountability for the operation of At Home Quality Care ... will establish policies ... and approve new or revised policies as needed ... annually review and revise policies and procedures ... will assist with operational plans ... All actions taken by the Governing Body will be documented in meeting minutes, which will be retained ... for a minimum of five (5) years ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “... Development of Policies and Procedures ....” stated “... Policies and procedures will be developed as necessary to provide guidance ... in providing care and services to patients ... Through the annual evaluation process, they will be reviewed and revised ... to address changing ... needs or requirements ... Personnel will have access to policies and procedures at all times ... All revisions will be assigned an effective date and if appropriate, a revised date and noted ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “... Orientation ....”, stated “... The orientation content for all personnel will include the following as applicable ... Drug testing ... Indiana home health aide drug testing ....” The policy included a copy of the (Indiana State Department of Health, Health Care Quality and Regulatory Services, Division of Acute Care) Program Advisory Letter with an effective date of 05/19/2017, titled “Home Health Care Agency Employee Drug Testing ....”, which stated “... the agency must, upon request ... Provide the agency’s written drug test policy ... Provide the employee’s acknowledgement of receipt of the drug testing policy ... Provide a policy defining which employees are considered affected ....” Upon survey exit, the agency specific written drug test policy, the employee’s acknowledgement of receipt of the drug testing policy, or a policy that defined which employees were considered affected was not submitted. During an interview on 11/17/2021 at 3:30 PM, a second request was made for the agency’s drug screen policy, which was submitted at 3:40 PM, by person A (corporate regulatory and resource specialist) titled “... Orientation ....” When queried if the if the policy evidenced when it was created, revised, approved, or who revised it, clinical manager B indicated she did not have that documentation here at this office, and they had to get it from the Governing Body. During this time, clinical manager B indicated she emailed to request a policy approval document. When queried who she emailed, clinical manager B stated “... Another branch ....” When queried which branch, she stated "Oak Forest" (a separately licensed home care agency in Illinois owned by the same corporation), and indicated she was the vice president of operations, she, and person A (not an agency employee) could revise policies, but administrator/RN (registered nurse) A couldn’t. When queried why the agency’s administrator could not revise policies, corporate regulatory and person A indicated they had a lot of facilities (home care agencies), administrator/RN A had "read only" access to policies, and stated “... otherwise, we'd have people changing these policies left and right ....” During an interview on 11/17/2021 at 3:50 PM, when queried if the policy approval document was received from Oak Forest, clinical manager B indicated it wasn’t, and nothing further was submitted upon survey exit. During this time, person A indicated the agency’s policy binders (located in the entrance area of the agency) didn’t contain the agency’s current/updated policies. When queried why current policies were not in the binders, person A indicated they had to pull them from the computer. When queried how the agency ensured all staff had access to the policies at all times, person A indicated they were working on it. During this time, all governing body minutes of meetings were requested for date range 01/2018 to present. A document received on 11/22/2021 at 3:03 PM, from clinical manager B, titled “Minutes of the Directors’ Meeting”, dated 11/13/2017, stated “... All other requirements for the new Conditions of Participation effective on [sic] January have been or will be implemented ....” A document received on 11/22/2021 at 2:38 PM, from clinical manager B, titled “... Minutes of the Directors’ Meeting”, dated 03/13/2018, stated “... Approval of Policies & Procedures that are ... (CHAP) compliant as well as compliant with relevant Federal and State Regulatory agencies ....” No additional governing body meeting minutes for the remainder of 2018, 2019, 2020, or 2021 were submitted upon survey exit. During an interview on 12/13/2021 at 10:45 AM, when queried to explain the agency’s process to update policies, clinical manager B indicated if they (policies) needed to be updated, corporate quality updated it, and the date on the bottom (of the policies) represented the most recent update from CHAP (all policies submitted for review had revised dates of either 2012 or 2015). During this time, person A indicated (they) we’re bad about dating the policies when updates were made, they were constantly updating policies, it was ever changing, and they’d need a whole team and a lot of time to go over every policy at the same time. An undated document titled “At Home Quality Care” was submitted on 11/17/2021, by administrator/RN (registered nurse) A, who indicated it was the agency’s organizational chart. The top center box indicated administrator/RN (registered nurse) A was the agency’s administrator and alternate clinical manager. To the left, and slightly below the top center box, was a box which indicated clinical manager B was the agency’s alternate administrator and clinical manager. The third row evidenced a box below clinical manager B, which indicated administrator/RN A was also the clinical manager. The document failed to evidence administrator/RN A reported to the governing body, the governing body was represented on the chart, or the role of vice president of operations was present on the chart. Clinical manager B’s personnel file was reviewed on 11/19/2021 at 2:10 PM. Documents dated 03/09/2020 and 03/12/2021, titled “Performance Evaluation” stated “... Name ... [clinical manager B] ... Job Location ... Corporate ... Job title ... Vice President [VP] Operations ....” The documents indicated the evaluations were completed by governing body person N. The record failed to evidence clinical manager B was an employee of the agency, a member of the governing body, a signed job description for clinical manager’s role as the agency alternate administrator or clinical manager. Administrator/RN A’s personnel file was reviewed on 11/22/2021, which evidenced an agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “... Home Health Administrator ....”. This policy evidenced administrator/RN A’s signature on the bottom of the form, but failed to evidence a date the document was signed, or who the administrator reported to. Additional documents dated 10/15/2017, 10/15/2018, 10/07/2019, and 10/12/2020 titled “Employee Performance Evaluation” evidenced administrator/RN A’s job title was “Director of Nursing (DON)- Chesterton”, performance evaluations were completed by clinical manager B, who identified her title as vice president of operations. The record failed to evidence a signed job description for administrator/RN A’s role as the agency Administrator or alternate clinical manager. During an interview on 11/17/2021 at 10:42 AM, when queried the names of the administrator, alternate administrator, clinical manager and alternate clinical manager, administrator/RN (registered nurse) A indicated she was the administrator and clinical manager, and clinical manager B was the alternate administrator and alternate clinical manager, and clinical manager B was “corporate”. During an interview on 11/17/2021 at 3:30 PM: When queried if clinical manager B was administrator/RN A’s “boss”, clinical manager B (who was also the alternate administrator) stated “Yes.” Administrator/RN A then indicated she agreed that clinical manager B was her “boss”. During this time, clinical manager B indicated she was not a direct employee of the agency, she was corporate level, but then recanted and indicated she was an agency employee. When queried to clarify how administrator/RN A was in charge of day-to-day operations since she reported to the alternate administrator/clinical manager B, clinical manager B indicated she was also the vice president of operations, which was a higher role in the corporation. During an interview on 11/18/2021 at 9:45 AM, when queried who administrator/RN A reported to, LPN (licensed practical nurse) H indicated she reported to clinical manager B. During an interview on 11/19/2021 at 10:30 AM, when queried who the administrator was, LPN E indicated clinical manager B was, because that’s who administrator/RN A answered to, and clinical manager B was “above” administrator/RN A. 17-12-1(b)

Administrator appointed by governing body CFR(s): 484.105(b)(1)(i) (i) Be appointed by and report to the governing body; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the administrator reported to the governing body. Findings include: An agency job description, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “ Job Title/Position ... Executive Director/Administrator” evidenced the executive director/administrator reported to the governing body. An undated document titled “At Home Quality Care” was submitted on 11/17/2021 by administrator/RN (registered nurse) A, who indicated it was the agency’s organizational chart. The top center box indicated administrator/RN (registered nurse) A was the agency’s administrator and alternate clinical manager. To the left, and slightly below the top center box, was a box which indicated clinical manager B was the agency’s alternate administrator and clinical manager. The document failed to evidence administrator/RN A reported to the governing body, the governing body was represented on the chart, or a role of vice president of operations was present on the chart. Administrator/RN A’s personnel file was reviewed on 11/22/2021, which evidenced an agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “... Home Health Administrator ....”. This policy evidenced administrator/RN A’s signature on the bottom of the form, but failed to evidence a date the document was signed, or who the administrator reported to. Additional documents dated 10/15/2017, 10/15/2018, 10/07/2019, and 10/12/2020 titled “Employee Performance Evaluation” evidenced administrator/RN A’s job title was “Director of Nursing (DON)- Chesterton”, performance evaluations were completed by clinical manager B, who identified her title as vice president of operations. The record failed to evidence a signed job description for administrator/RN A’s role as the agency Administrator or alternate clinical manager. Clinical manager B’s personnel file was reviewed on 11/19/2021 at 2:10 PM. Documents dated 03/09/2020 and 03/12/2021 titled “Performance Evaluation” stated “... Name ... [clinical manager B] ... Job Location ... Corporate ... Job title ... Vice President [VP] Operations ....” The documents evidenced the evaluations were completed by governing body person N. The record failed to evidence clinical manager B was an employee of the agency, a member of the governing body, a signed job description for clinical manager’s role as the agency alternate administrator or clinical manager. During an interview on 11/17/2021 at 10:42 AM, when queried the names of the administrator, alternate administrator, clinical manager and alternate clinical manager, administrator/RN A indicated she was the administrator and clinical manager, and clinical manager B was the alternate administrator and alternate clinical manager, and clinical manager B was “corporate”. When queried the names of the members of the governing body, administrator/RN A indicated persons N, O, and P were the members of the governing body. During an interview on 11/17/2021 at 3:30 PM, when queried if clinical manager B was administrator/RN A’s “boss”, clinical manager B, (who was also the alternate administrator) stated “Yes.” Administrator/RN A then indicated she agreed clinical manager B was her “boss”. During this time, clinical manager B indicated she was also the vice president of operations, which was a higher role in the corporation. During an interview on 11/18/2021 at 9:45 AM, when queried who administrator/RN A reported to, LPN (licensed practical nurse) H indicated she reported to clinical manager B. During an interview on 11/19/2021 at 10:30 AM, when queried who the administrator was, LPN E indicated clinical manager B was, because that’s who administrator/RN A answered to, and clinical manager B was “above” administrator/RN A. 17-12-1(b)(1)

Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This ELEMENT is not met as evidenced by: Based on record review and interview, the administrator failed to be responsible for the day-to-day functions of the agency. Findings include: An agency job description, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “ Job Title/Position ... Executive Director/Administrator” stated “... Responsible for planning, coordinating, managing and directing all activities and programs of the At Home Quality Care ....” During an interview on 11/18/2021 at 2:15 PM, administrator/RN A submitted an undated, untitled document. Administrator/RN A indicated it was the agency’s list of employees. When queried if it contained all agency employees, she indicated it was the agency’s current employee list of all employees. The document failed to include clinical manager B was listed as an agency employee. During an interview on 11/17/2021 at 3:30 PM: When queried if she was administrator/RN A’s “boss”, clinical manager B, who was also the alternate administrator stated “Yes.” Administrator/RN A then indicated she agreed that clinical manager B was her “boss”. During this time, clinical manager B indicated she was not a direct employee of the agency, she was corporate level, but then recanted and indicated she was an agency employee. When queried who was responsible for the day-to-day operations of the agency, clinical manager B indicated administrator/RN A was. When queried to clarify how administrator/RN A was in charge of day-to-day operations, since she reported to the alternate administrator/clinical manager B, clinical manager B indicated she was also the vice president of operations, which was a higher role in the corporation. During this time, a second request was made for the agency’s drug screen policy, which was submitted at 3:40 PM, by person A (corporate regulatory and resource specialist) titled “... Orientation ....” When queried if the if the policy evidenced when it was created, revised, approved, or who revised it, clinical manager B indicated she did not have that documentation here at this office, and they had to get it from the Governing Body, and indicated she emailed to request a policy approval document. When queried who she emailed, clinical manager B stated “... Another branch ....” When queried which branch, she stated "Oak Forest" (a separately licensed home care agency in Illinois owned by the same corporation), and indicated she was the vice president of operations, she, and person A (not an agency employee) could revise policies, but administrator/RN (registered nurse) A couldn’t. When queried why the agency’s administrator could not revise policies, person A indicated they (the corporation) had a lot of facilities (home care agencies), administrator/RN A had "read only" access to policies, and stated “... otherwise, we'd have people changing these policies left and right ....” During an interview on 11/18/2021 at 9:45 AM, when queried who administrator/RN A reported to, LPN (licensed practical nurse) H indicated she reported to clinical manager B, the main office was in Illinois, clinical manager B was from the Illinois office, and she oversaw all of the offices. During an interview on 11/19/2021 at 10:30 AM, when queried who the administrator was, LPN E indicated clinical manager B was, because that’s who administrator/RN A answered to, clinical manager B was “above” administrator/RN A, and this agency was a branch of the Illinois office. 17-12-1(c)(1)

In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the registered nurse contacted the patient’s physician(s) to verify and/or obtain order(s) for medications a family reported he/she administered to the patient, instructed a family member to administer medication(s) to the patient without first verifying and/or obtaining orders from the physician(s); failed to contact the physician and/or provide a skilled nursing assessment for a reported significant change in the patient’s condition; instructed a family member to contact the physician him/herself to report signs/symptoms of a significant change in condition, and instructed a family member to contact the physician him/herself to request medication(s) related to new onset signs/symptoms for 1 of 11 records reviewed (#2). Findings include: A State document readopted 11/25/2019, titled “Article 2. Standards For the Competent Practice of Registered and Licensed Practical Nursing” stated “... Registered Nursing ... The registered nurse shall do the following ... Initiate nursing actions to assist the patient/client to maximize his or her health capabilities ... Evaluate with the patient/client the status of goal achievement as a basis for reassessment, reordering priorities, new goalsetting, and revision of the plan of nursing care ... Responsibility as a member of the nursing profession ... Communicate, collaborate, and function with other members of the health team [a group of health care providers which may, in addition to physicians and practitioners, include the patient/client, family, and any significant others] to provide safe and effective care ... Unprofessional conduct ... Nursing behaviors (acts, knowledge, and practices) ... which could jeopardize the health, safety, and welfare of the public, shall constitute unprofessional conduct ....” An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... The comprehensive assessment for each patient ... documented in the patient’s clinical record ... including at least the following ... current medication use, including prescription, over-the-counter medications and herbal medications ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Medication Profile” stated “... will have a current, accurate medication profile in the clinical record ... Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications ... During subsequent home visits, the medication profile will be used ... to evaluate the use of medications ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Physician Participation in the Plan of Care ....” stated “... A physician will direct the care of every home health patient admitted for service .... will participate ... by initiating, reviewing and revising therapeutic and diagnostic orders ... care will be provided in compliance with the ... orders ... orders will be individualized ... and include ... medications ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Care Planning Process” stated “... The clinical plan of care includes ... Medications ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment” stated “... the assessment will be patient specific and comprehensive ... will be completed ... [for] ... Significant change in condition ... must be conducted by a registered nurse ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Ongoing Assessments” stated “... Re-assessments should focus on ... Changes in patient condition ....” An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Reassessments/Recertification” stated “... The comprehensive assessment must be updated and revised ... as warranted by the condition of the patient ... assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician ... will be completed within the mandated timeframes ... must include ... any changes in patient status ....” A drugs.com web-based reference reviewed on 12/08/2021, https://www.drugs.com/dosage/clonidine.html, titled “Clonidine Dosage” stated “... Usual Adult Dose for Hypertension ... Maximum dose: 2.4 mg orally per day in divided doses ....” A drugs.com web-based reference reviewed on 12/08/2021, https://www.drugs.com/compare/atorvastatin-vs-pravastatin, titled “Comparing Atorvastatin vs Pravastatin” stated “... Pravastatin is effective at lowering cholesterol; however, it may not be as effective as atorvastatin ....” Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, and certification period 11/23/2021 – 1/21/2022. During an interview on 12/08/2021 from 11:00 AM – 12:00 PM, the patient’s family verbally consented for the surveyor to take pictures and discuss text messages exchanged between the family member and RN I, which evidenced the following: A text was observed dated 10/21/2021 at 2:41 PM, which indicated the family informed RN I the patient was prescribed a “low dose medication to treat depression”. The clinical record failed to evidence the nurse followed up to verify the medication name or directions for use. A text was observed from family to RN I on 11/03/2021 at 2:44 PM, “She is doing better since I started the Mylicon drops [anti-gas medication] and i [sic] stopped giving her the miralax [laxative]”, RN I replied at 1:08 PM, “Ok & let’s stay on the Zofran [medication for reduction/prevention of nausea/vomiting] round the clock. The clinical record evidenced Zofran was prescribed every 8 hours as needed, failed to evidence orders for miralax or Mylicon, and failed to evidence the nurse contacted the physician to request a change for the Zofran to be a regularly scheduled medication instead of as needed. A text was observed from family to RN I on 11/10/2021 at 8:38 AM, which stated “... at 5am ... gave her ... tylenol and her new nausea medicine ....”; RN I replied at 9:02 AM “You can ask for a suppository for the nausea”. The record failed to evidence an order for tylenol, the nurse verified the new nausea medication prescription, or contacted the physician for a suppository. A text was observed from family to RN I on 11/11/2021 at 8:00 AM, which indicated the patient was at the emergency department (ED). Family texted RN I again at 12:07 PM, and included pictures she took of ED paperwork, which indicated the patient was prescribed Tessalon (to treat coughing), Reglan (to treat heartburn), pantoprazole (anti-acid), loperamide/imodium (to treat diarrhea), Synthroid (thyroid hormone replacement) 88 mcg (micrograms), and amlodipine/Norvasc (to treat high blood pressure) 10 mg (milligrams) daily; RN I replied at 12:13 PM “The Reglan may help but still use the Zofran ....”. An agency document titled “Medications for [patient] effective 11/17/2021” failed to evidence the nurse obtained orders for medications the patient used, or who prescribed them, which included a low dose medication to treat depression, Mylicon drops, miralax, Zofran was scheduled instead of as needed, tylenol, the new nausea medication prescription, Tessalon, Reglan, pantoprazole, or amlodipine/Norvasc. A text was observed from family to RN I on 11/19/2021 at 4:20 PM, “... should I keep giving her the Metamucil [fiber supplement]”, RN I replied at 4:21 PM, “I would say no but let me double check on Monday with the dietician”. The clinical record failed to evidence the nurse obtained an order for the Metamucil. During this interview and text message review, when queried if the nurse ever followed up on the Metamucil, family stated “No, she didn’t.” A text was observed from family to RN I on 11/21/2021 at 2:40 PM, “... [the patient’s] BP [blood pressure] has been high all day ... took a clonidine [sedative and anti-hypertensive] at 1pm”, RN I immediately replied “The clonidine is 10 mg? Is it prescribed once a day?”, family at 2:48 PM, “It is .1 [one tenth of 1 mg] mg every 8 hours”, RN I replied at 2:53 PM, “Yes go ahead and take it again now. Also, lisinopril, does she just take that daily? Are her legs swollen?”, family replied at 2:55 PM, “Yes she does take that ....”, RN I replied at 3:15 PM, “Do you have any Lasix ....”, family immediately replied “Yes”, RN I replied at 3:17 PM, “I think her blood pressure is elevated because of extra fluid. You’ve been instructed that you can give the Lasix if her legs are swollen, right?”, family replied at 3:21 PM, “Lasix is 40mg should [sic] give her one?”, an additional text from family at 3:25 PM stated “The script [prescription bottle] says 6 a day [240mg]”, RN I replied at 3:28 PM, “Let’s try the Lasix & see if it helps”, family replied at 3:34 PM, “How many should I give her”, RN I replied at 3:35 PM, “Just give her one Lasix 40 mg”; RN I texted family at 7:58 PM, “You could give her another clonidine”, and family replied that she did give it. Family texted RN I at 8:31 PM, “Do I have to wait 8 hours before I can give her another one”, RN I replied at 8:35 PM, “No not if her blood pressure is high”, family replied “She [patient]said the hospital was giving her one an hour ....”, RN I replied, “That sounds reasonable to me”, and family replied, “Ok thanks”. The texts evidenced the nurse instructed family to administer clonidine at a greater frequency than family indicated it was ordered, family indicated it was ordered every 8 hours, the nurse instructed her every hour “seemed reasonable”, was unsure and had to ask family indications for administration of Lasix and instructed family to administer Lasix. The record failed to evidence the nurse verified or obtained an order for clonidine, clarified the indications for the use of Lasix prior to instructing the family to administer the medications, or RN I provide a skilled nursing assessment for a reported significant change in the patient’s condition. A text was observed from RN I to family on 12/03/2021 at 8:53 AM, “... did Dr. [unknown physician] get back with you about the Lasix dose yet?” At 8:55 AM, family replied “No I need to find out also for the Lisinopril the sheet says 1 per day and she has been taking 2 a day?”, another text at 9:01 AM “She has a lot of carvedilol [to treat high blood pressure and heart failure] tabs the sheet says I doubled the ones she has. She also has a full bottle of Pravastatin can I give her all of these first before I use the atorvastatin?”, and RN I failed to respond to this text. The record indicated lisinopril and carvedilol were ordered to be taken only on non-dialysis days (the patient went to dialysis on Mondays, Wednesdays, and Fridays); and failed to evidence an order for pravastatin, the nurse contacted the physician to clarify the orders for pravastatin, lisinopril or carvedilol, indications and use for use of Lasix, or RN I followed up with family to clarify the patient’s correct medication regimen. A text was observed from family to RN I on 12/04/2021 at 9:27 AM, “... If I contact [primary care physician R’s] office do you think they will call in some cough medicine?”, RN I replied “... I’m sure they would ... If they didn’t you could always ask the pharmacist to look at [patient’s] medication profile and recommend a cough medicine that would not interact with her other medications ....”, RN I texted at 10:04 AM, “Yes I would call over there make sure you let them know the exact symptoms. It sounds like she needs a cough suppressant and expectorant. Let me know ....” Family replied at 10:25 AM, “The doctor on call wants me to take her to the ER [emergency room] ....”, family texted again at 11:01 AM “She woke up but doesn’t want to go to the ER so I will go get her some Musanex [sic] [Mucinex - an expectorant. It helps loosen chest and throat congestion] ....” RN I replied at 11:04 AM, “Okay sounds good ... Call me if you feel I need to listen to her lungs” The record failed to evidence the nurse contacted the physician or pharmacy herself to request an order for a cough suppressant and expectorant, an order for Mucinex, which the nurse indicated was okay to administer, or RN I provided a skilled nursing assessment for a reported significant change in the patient’s condition A text was observed from family to RN I on 12/06/2021 at 4:53 PM, “Are you close bye [sic] by chance! [patient’s] acting strange.” RN I replied, “No I’m not strange how”, family replied “Very weak I had to call for help to clean her up”, RN I replied at 4:57 PM “Can you get a BP and [heart] rate for me please”, family replied at 4:59 PM “110/50. [heart rate] 71”, RN I replied at 5:04 PM “I just spoke with [administrator/RN A] and she said with the low blood pressure and the weakness, which is a major change, she needs to go to the emergency room”, family replied “She doesn’t want to go she wants me to call [cardiologist QQ]”. At 5:17 PM, RN I texted “Do you think the doctor will be available at this time?” The record failed to evidence RN I or another nurse provided a skilled nursing assessment for a reported significant change in the patient’s condition. A text was observed from RN I to family on 12/07/2021 at 9:24 AM, “... how is her BP this [morning]", family replied at 9:31 AM "It is 145/81 ... but she is acting differently”, RN I replied at 9:37 AM, “How?”, family replied at 9:39 AM “Moaning! Very confused! I think she had a stroke the right side of her face is droopy”, RN I replied “What did the doctor say about the Lasix? Is she having mental status changes”, at 10:32 AM, RN I texted “On my way ....” At 1:15 PM, family texted “[cardiologist QQ] said no on the Lasix ....”, RN I replied, “OK let’s see what the nephrologist [kidney doctor] says as well Because if nephrology says something different I’m going to have to call and ask them to talk to each other”, and family replied “Ok”. At 1:20 PM, RN I texted “I don’t understand how [cardiologist QQ’s] office can even make that call right now they don’t have enough information ... you watch her for changes ....” The nurse failed to contact the physician directly for a clarification order for the use of Lasix. During this interview and text review (12/08/2021 at 11:00 AM), family indicated cardiologist QQ’s nurse called her back yesterday, and confirmed the patient was not supposed to take Lasix. When queried where she got the Lasix, family indicated it was just an old bottle she had from when the patient used to take 240mg daily before the g-tube was placed, and she didn’t know she wasn’t supposed to administer it. During an interview at dialysis facility F on 12/08/2021 from 9:55 AM – 10:45 AM, when queried about communication interactions from the agency, person G (staff member at facility) indicated she believed yesterday was the first actual phone call from a nurse to report on the patient, person RR (a dietician with the dialysis facility) indicated she’s had no direct contact with the agency, she did all communication via the patient’s family, she never talked to the agency, and didn’t even know what agency cared for the patient; person CC (RN from dialysis facility) indicated she didn’t recall ever speaking to anyone from the agency prior to yesterday, and when queried about the use of Lasix, she indicated the physician that placed the patient’s g-tube (09/21/2021), discontinued the Lasix; person SS indicated she called the agency to inform them that primary care physicians usually manage plans of care and other orders, the home health agency staff never talked to physician LL (dialysis facility F’s physician) about the agency’s plan of care, and physician B (signed the initial plan of care) retired from this facility about a year ago, but still rounded in the hospital on the weekends. When queried if there was ever communication from the agency about the patient’s medication regimen, person G (staff member at facility) indicated prior to yesterday, the only communication this facility has had about medications was with the patient, and she would like the home health agency to send her a list of the patient’s medications they indicated she took. During an interview on 12/7/2021 at 1:54 PM, when queried about dietician services due to the patient’s fragile condition, administrator/RN A indicated the patient saw a dietician at dialysis facility F. When queried if the record evidenced any care coordination with the dialysis facility, administrator/RN A stated “Nope.”

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the patient’s clinical record failed to include all physician orders (See G1012); failed to document the patient’s response(s) to interventions provided, and/or failed to document the date and/or time, or name of physician or representative spoken to, when a physician was contacted for orders and/or order requests (See G1014); and failed to ensure all clinical documents were complete, appropriately authenticated, dated, and timed; and/or authentication included a secured computer entry of the primary author who reviewed and approved the entry (See G 1024). This practice had the potential to affect all agency patients. The cumulative effect of these systemic problems resulted in the home health agency's noncompliance for the Condition of Participation 42 CFR §484.110: Clinical Records. 17-15-1(a)(3) 17-15-1(a)(7)

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the patient’s clinical record failed to include physician orders for 5 of 11 records reviewed (#1, 2, 3, 4, 5). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Contents of Clinical Record ....” stated “... The clinical record will contain ... Signed and dated progress notes for each discipline ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Verification of Physician Orders ....” stated “... All telephone orders or verbal orders will be ‘read back’ to the physician ... to assure accuracy ... Orders will be documented ... dated and signed by the professional receiving the order ....” 3. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2015, titled “Transfer/Referral Criteria and Process” stated “... When the patient’s needs change significantly ... requires care that cannot be provided by the ... [agency] ... The physician (or other authorized independent practitioner) will be notified and an order will be obtained to transfer the patient ....” 3. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, which evidenced a document signed and dated by administrator/RN A on 10/29/2021, titled “... Recertification [comprehensive assessment] ....”, which stated “... MD notified of recertification completion ....” The record failed to evidence an order for services provided during the interim, when the physician signed the plan of care on 11/12/2021. A document titled “Home Health Certification and Plan of Care” for certification period 11/02/2021 – 12/31/2021 was dated and signed by family nurse practitioner (FNP) C on 11/12/2021. 4. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, and certification period 11/23/2021 – 1/21/2021, evidenced a document dated and signed by RN I on 09/24/2021 titled “...Start of Care ....”, which stated “... Date of Physician-ordered Start of Care ... If the physician ... indicated a specific start of care ... date ... 9/24/2021 ....” The record failed to evidence an order which indicated the physician ordered the services to begin on 09/24/2021, the nurse contacted the physician to review/approve the plan of care, or an order for services provided during the interim, when the physician signed the plan of care on 10/18/2021. During an interview on 11/17/2021 at 2:30 PM, when queried when the patient’s plan of care was signed by the certifying physician, administrator/RN A indicated it was signed on 10/18/2021. A document dated and signed by RN I on 10/12/2021 titled “... Resumption of Care ....” (comprehensive assessment), evidenced the patient was discharged from the hospital on 10/08/2021, and the physician ordered the resumption of care visit to occur on 10/12/2021. The record failed to evidence a physician order to resume home health services on 10/12/2021. During an interview on 12/07/2021 at 1:54 PM, when queried why the resumption of care (comprehensive assessment) occurred 4 days after the patient was discharged from the hospital (discharge date of Friday, 12/08/2021), alternate clinical manager A stated, “ I don’t think we even knew she was home ....”, and indicated she faxed (hospital D) on Monday, 10/11/2021 for patient’s hospitalization records, and received them on 10/12/2021. When queried why the comprehensive assessment dated 10/12/2021 indicated the physician ordered the resumption of care to occur on 10/12/2021, the clinical and alternate clinical managers both indicated they didn’t know why. A document dated and signed by RN I on 10/19/2021, visit time 12:30 PM – 1:30 PM, titled “... SN Visit Note”, evidenced the patient did not go to dialysis this date due to fatigue, nurse assessed “significant decline in respiratory status”, “ patient’s respiratory status declining”, nurse requested for family to transport to ED (emergency department), but family indicated she would take the patient to urgent care. The record failed to evidence an order to send the patient to the emergency department for evaluation. 5. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, evidenced a document dated 08/20/2021, signed by PT J on 08/30/2021, titled “... PT Start of Care ....”, which failed to evidence PT J contacted the physician to review/approve the plan of care, and stated “... Physician Signature ... see 485 [plan of care] ... no MD signature required ....” A document titled “Home Health Certification and Plan of Care” for certification period 08/20/2021 – 10/18/2021 was dated and signed by PT J on 08/30/2021, and physician MM on 09/03/2021. The record failed to evidence an order for services provided during the interim, when the physician signed the plan of care on 09/03/2021. 6. Record review for patient #4 was completed on 12/15/2021, start of care date 10/29/2021, certification period 10/29/2021 – 12/27/2021, evidenced a document dated 10/29/2021, signed by PT J on 11/02/2021, titled “... PT Start of Care ....”, which failed to evidence PT J contacted the physician to review/approve the plan of care, and stated “... Physician Signature ... see 485 [plan of care] ... no MD signature required ....” A document titled “Home Health Certification and Plan of Care” for certification period 10/29/2021 – 12/27/2021 was dated and signed by PT J on 11/02/2021, and FNP C on 11/02/2021. The record failed to evidence an order for services provided during the interim, when FNP C signed the plan of care on 11/02/2021. 7. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, which evidenced a document signed and dated by administrator/RN A on 09/08/2021, titled “... Start of Care [comprehensive assessment] ....”, which failed to evidence the nurse contacted the physician for review/approval of the plan of care, or an order for services provided during the interim, when the physician signed the plan of care on 09/28/2021. A document titled “Home Health Certification and Plan of Care” for certification period 09/08/2021 – 11/06/2021was dated and signed by physician NN on 09/28/2021. 8. During an interview on 11/17/2021 at 10:42 AM, when queried the timeframe allowed for clinicians to submit documentation following a visit, administrator/RN A indicated she preferred 48 hours for start of care/admissions, and 24-48 hours for regular visits. When queried the timeframe for documents to be incorporated in the patient’s record, she indicated the record was electronic, so it was immediate. 9. During an interview on 11/30/2021v at 12:30 PM, when queried if care should be performed prior to receiving a signed plan of care, clinical manager B stated “... Yes, because we have an initial order for assess and treat ....”, and indicated orders were documented in the EMR. When queried if clinician notes should be signed and dated by the client and staff that made a visit, clinical manager B stated “... Yes for the clinician, but no visit verify ....” When queried should a verbal order be signed, dated, timed, and include who it was received by, clinical manager B stated “...Yes” When queried the timeframe for when a written verbal order was sent to the physician for signature, clinical manager B stated “... Within 24 hours ....”, and she indicated she would expect the signed order to be received by the agency within 7 days. When queried if she expected all entries into the clinical record to be accurate and complete, clinical manager B stated “Yes.” 17-15-1(a)(3)

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the skilled nurse (SN) failed document the patient’s response(s) to interventions provided; and/or failed to document the date and/or time, or name of physician or representative spoken to, when a physician was contacted for orders and/or order requests, for 9 of 11 records reviewed (#1, 2, 5, 6, 7, 8, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Monitoring Patient’s Response/Reporting to Physician ....” stated “... Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit ... including ... but not limited to ... Teaching ... Documentation of the physician notified will include ... Date and time ... Name of physician ... or ... representative ... [or] name of person taking message ....” 2. A home visit was observed for patient #1 on 11/18/2021 at 9:00 AM, with LPN (licensed practical nurse) H. The patient was resistant both physically and verbally to LPN H’s requests to remove her glasses for transfer to bed for wound care, could not follow commands, and speech was not understandable. The patient moaned with pain during transfer, and cried out in pain during wound care and upon position change. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, which was dated and signed by LPN [licensed practical nurse] H on 11/18/2021, and stated, “... No verbal or non-verbal cues of pain except for with wound care ... Instructed facility nurse ... on wound care ....” The document failed to evidence the patient moaned with pain during transfer and upon position change, or the facility nurse’s response to instruction provided. 3. A home visit was observed with patient #2 on 11/18/2021 at 12:55 PM with RN I. Upon arrival, the patient was coughing and choking uncontrollably, with tears streaming down her face. Family indicated she just had a couple sips of fluid, and she always did this. During this time, family indicated the dietician switched the patient’s g-tube (a tube inserted directly into the stomach for administration of nutrition, fluids, and medications) feeding to Neosure (nutritional supplement/replacement), the patient seemed to tolerate it better, the patient received 1 can 3 times per day, and indicated she was (family) very overwhelmed with the patient’s complex needs. During this time, RN I did not discuss regulatory requirements with patient and or significant other including hotline number, hours and purpose, OASIS (outcome and assessment information set) privacy statement, transfer/discharge policies explained, and a disaster plan was not discussed or developed. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, and certification period 11/23/2021 – 1/21/2022. Record review evidenced a document dated and signed by RN I on 11/18/2021, titled “... Recertification [comprehensive assessment] ....”, which evidenced RN I discussed regulatory requirements with patient and or significant other including hotline number, hours and purpose, OASIS privacy statement, transfer/discharge policies explained, and disaster plan developed, but failed to include the patient/caregiver response; instructed on Nepro (g-tube supplemental feeding) 8 ounces 4 times daily with “continuing education needed”, assessed for and instructed patient/family for signs or symptoms of aspiration with “continuing education needed”, and stated “... difficulty swallowing ... coughing and clearing throat after drinking regular liquids ... clears throat and coughs after small sips ....”; RN I notified physician R, and received an order for speech therapy. The document failed to indicate the correct g-tube feeding was Neosure, the patient’s tolerance, the observed aspiration with uncontrolled coughing after sipping fluids, or the time the order was received. During an interview on 12/07/2021 at 10:50 AM, when queried if the record evidenced the patient/caregiver response to teaching or observed correct demonstration/teach-back, clinical manager B indicated it did not. A document authenticated/electronically signed on 11/04/2021 at 7:42 PM, by administrator/RN A at 7:42 PM, titled “Physician Supplemental Order” stated, “... DC [discharge] PT and OT per patient request, not feeling well ....” The document failed to evidence the time the order was received. A document dated 11/24/2021, titled “Physician Supplemental Order” evidenced RN I received an order on 11/24/2021, no time was documented, and stated “... Decrease SN [skilled nursing] visits to 1x [1 time] a week eff [effective] week of 11/24 per patient request ....” The document was not signed by RN I or the physician, and failed to evidence the time the order was received. During an interview on 12/9/2021 at 12:26 PM, as follow up to the interview conducted on 12/08/2021 at 3:02 PM, clinical manager B indicated the order dated 11/24/2021 to decrease nursing visits to weekly was actually written by administrator/RN A on 12/7/2021, but entered as RN I. When queried how the patient requested to have her visits decreased when she was in the hospital during that time, experiencing a heart attack, clinical manager B did not respond. A hospital D document dated 11/24/2021, titled “Consultation Notes”, evidenced the patient was treated in the emergency department on 11/23/2021. A hospital D document dated 11/24/2021, titled “Cardiovascular Institute”, evidenced the patient received surgical intervention to her heart on 11/24/2021 (stent placement). 4. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, certification period 09/08/2021 – 11/06/2021, which evidenced a document dated and signed by administrator/RN A on 09/08/2021 at 7:24 AM, titled “... Start of Care ....”, which evidenced the nurse performed wound care, instructed on signs and symptoms of UTI (urinary tract infection), and infection. The document failed to evidence the patient’s response to the wound care or teaching interventions. 5. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, certification period 10/25/2021 – 12/23/2021, which evidenced a document dated and signed on 10/29/2021, by LPN H, titled “... SN Visit Note”, which evidenced wound care was performed, and other interventions including instructed to limit sodium intake, take medications as ordered, exercise recommended, and don’t overdo activity, but failed to evidence the patient’s response to teaching and tolerance of wound care; pain interventions included pace activities, exercise, and medications,; and stated “... Response to pain management ... [box checked] N/A [not applicable] ....” 6. A home visit was observed on 11/22/2021 at 10:30 AM, with licensed practical nurse (LPN) E present. LPN E was observed to perform wound care. During this time, the patient frequently yelled out in pain, moaned, retracted her leg in pain, required several breaks during wound care to reposition due to pain, requested pain medication for severe pain. and the patient indicated she was just ready to get her leg amputated. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, certification period 10/30/2021 – 12/28/2021, which evidenced a document dated 11/22/2021, titled “...SN Visit Note”, and indicated the patient had pain, wound care was provided, and stated “... Wound care completed as ordered. Patient tolerated fairly well ....” The document failed to evidence the patient’s actual response to the wound care. 7. Record review for patient #8 was completed on 12/15/2021, start of care date 04/12/2021, certification period 06/11/2021 – 08/09/2021, transfer/discharge date 07/20/2021, which evidenced a document dated and signed by administrator/RN A on 06/09/2021, titled “... Recertification ....”, which stated “... wound care done per orders ... Instructed on fall prec [precautions] and safety in home ... s&s [signs and symptoms] of infection ....” The document failed to evidence the patient’s response to the wound care or teaching intervention provided. A document dated and signed by administrator/RN A on 07/20/2021 at 8:04 PM, titled “... Physician Supplemental Order” evidenced an order was received on 07/20/2021 to hold home health services, but failed to evidence the time the order was received. 8. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, certification period 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021, which evidenced a document dated and signed by administrator/RN A on 04/30/2021 at 7:24 AM, titled “... Start of Care ....”, and indicated the nurse obtained a blood specimen for therapeutic drug monitoring, results were called to physician, instructed on proper nutrition, and to increase fluid intake. The document failed to evidence what physician results were called to, the time the call was made, who she spoke to, or if new orders were received; and failed to evidence the patient and/or caregiver’s response to teaching interventions provided. 9. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, certification dates 11/07/2021 – 01/05/2022, which evidenced a document received on 12/09/2021, dated 11/07/2021, titled “... Start of Care ....” and indicated RN I performed wound care to 5 wounds on the patient’s body, and failed to evidence the patient’s response to the interventions. An agency document titled “Physician Supplemental Order (Resume Care Orders)”, received on 12/09/2021, evidenced an order was received by the agency on 12/01/2021, RN I requested the order, and the document failed to indicate RN I authenticated/electronically dated, signed, or completed the document, indicated who she spoke to, or the time the order was received. 10. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, and certification dates 12/07/2021 – 02/04/2022, which evidenced a document received on 12/14/2021 at 11:48 AM, dated and signed 12/13/2021, by RN G at 8:29 PM, titled “Physician Supplemental Order” and indicated antibiotics and ensure nutritional supplement were ordered. The document failed to evidence the time the order was received, or the date and time the order was edited, or who the nurse spoke to. During an interview on 12/14/2021 at 11:51 AM, the EMR evidenced the order was edited on 12/14/2021, failed to evidence what edited, or date/time of edit. When queried why the date wasn’t updated, administrator/RN A and clinical manager B both indicated they didn’t know. When queried what was edited, clinical manager B indicated she didn’t know, and administrator/RN A stated, “She added the ensure on there I assume ....” A home visit was observed at ALF (assisted living facility) K on 12/15/2021 at 10:06 AM, with administrator/RN A, RN G, and surveyor P also present. During wound care, the patient yelled out in pain, flinched, grabbed at wounds, and yelled for the nurse to stop. When the patient was positioned onto her right side after all care was completed, she yelled out in pain as her leg was lifted to prop a blanket between her knees. A document dated and signed by RN G on 12/15/2021 at 11:21 AM, titled “...SN Visit Note” evidenced the patient’s current pain was “aching”, the nurse requested pain medications to pre-medicate prior to dressing changes, the nurse performed wound care to several areas of the patient’s body, and failed to evidence the patient’s response to wound care included the patient yelled out in pain, flinched, grabbed at wounds, and yelled for the nurse to stop; and failed to evidence the patient’s response to being repositioned onto her right side after all care was completed, and the fact that she yelled out in pain as her leg was lifted to prop a blanket between her knees. 11. During an interview on 11/18/2021 at 11:00 AM, when queried if a verbal order should include the date, time, and who the clinician spoke to, administrator/RN A stated “Yes.” When queried if the clinicians called the physician to review/approve the plan of care, she indicated they did, but she didn’t think it was recorded in the record. 12. During an interview on 11/30/2021 at 12:30 PM, when queried if a verbal order should be signed, dated, timed, and include who it was received by, clinical manager B indicated it should. 13. During an interview on 12/14/2021 at 12:22 PM, when queried if the patient/caregiver response to teaching should be included in documentation, clinical manager B indicated it should.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure all clinical documents were complete, appropriately authenticated, dated, and timed; and/or authentication included a secured computer entry of the primary author who reviewed and approved the entry for 9 of 11 records reviewed (#1, 2, 3, 5, 6, 7, 9, 10, 11). Findings include: 1. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Care Planning Process ....” stated “... The patient plan of care will be developed or revised within five (5) working days of initiation of each service ... or ... reassessment ... At the time of the initial assessment ... will develop the plan of care based upon the patient’s identified needs ,,, review with ... patient ....” 2. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Initial and Comprehensive Assessment ....” stated “... A plan of care will be developed from the information gathered during the initial and comprehensive assessment ....” 3. An agency policy, copyright the corridor group 2003, CHAP (Community Health Accreditation Partner- an independent, nonprofit accrediting organization for home and community-based health care organizations) Home Health Manual/revised April 2012, titled “Contents of Clinical Record ....” stated “... The clinical record will contain sufficient information to ... describe the patient’s problems and needs ... accurately document care provided and results in detail ... Legible, complete, and individualized orders ... Relevant diet or dietary restrictions ... Signed and dated progress notes for each discipline ... Transfer/discharge summaries and other summary (60-day) sent to the physician ....” 4. An agency policy, copyright the corridor group 2003, CHAP Home Health Manual/revised April 2012, titled “Verification of Physician Orders ....” stated “... All telephone orders or verbal orders will be ‘read back’ to the physician ... to assure accuracy ... Orders will be documented ... dated and signed by the professional receiving the order ....” 5. Record review for Pt #1 was completed on 12/15/2021, start of care date 9/3/2021, for certification period 11/02/2021 – 12/31/2021, which evidenced the patient was disoriented, and evidenced a document signed and dated by clinical manager B on 11/11/2021 at 3:15 PM, titled “LPN [licensed practical nurse] Sup [supervisory] Visit”, which stated “... Patient is satisfied with [LPN H] ....” The document failed to evidence if the supervisory visit was performed in the presence of the patient, or by phone. A home visit was observed on 11/18/2021 at 9:00 AM, with LPN H. The patient was resistant both physically and verbally to requests to remove her glasses for transfer to bed for wound care, could not follow commands, and speech was not understandable. During this time, LPN H indicated the patient sometimes followed commands. During an interview on 11/30/2021 at 12:30 PM, when queried how often were phone supervisory visits conducted, and for what reason, clinical manager B indicated if there was a complaint, the first step was a phone call, but “in person” was the agency’s practice, and it was documented if it was a phone supervisory visit. During an interview on 11/30/2021 at 1:30 PM, when queried if the supervisory visit performed at the patient’s home, clinical manager B indicated she did not perform an on-site visit, she thought the supervisory visit was due, she made a call to the facility, and did not talk to the patient. When queried if she knew the patient’s mental status/orientation level, clinical manager B indicated she wasn’t sure. 6. Record review for patient #2 was completed on 12/15/2021, start of care date 9/24/2021, for certification period 9/24/2021 – 11/22/2021, and certification period 11/23/2021 – 1/21/2022. Record review evidenced a document dated and signed by RN [registered nurse] I on 10/12/2021 titled “... Resumption of Care ....” (comprehensive assessment), which indicated the patient was discharged from the hospital on 10/08/2021, and the physician ordered the resumption of care visit to occur on 10/12/2021. During an interview on 12/07/2021 at 1:54 PM, when queried why the resumption of care (comprehensive assessment) occurred 4 days after the patient was discharged from the hospital (discharge date of Friday, 12/08/2021), alternate clinical manager A stated, “ I don’t think we even knew she was home ....”, and indicated she faxed (hospital D) on Monday, 10/11/2021 for patient’s hospitalization records, and received them on 10/12/2021. When queried why the comprehensive assessment dated 10/12/2021 indicated the physician ordered the resumption of care to occur on 10/12/2021, the clinical and alternate clinical managers both indicated they didn’t know why. The record and hospital discharge documents failed to evidence a physician’s order to resume services on 10/12/2021. During an interview on 12/08/2021 at 11:00 AM, family verbally consented for surveyor to screen shot text messages between herself and RN I. A text message was observed sent from family to RN I on 10/08/2021 at 1:24 PM, which stated “[patient] is going to be discharged around 3 [PM]”, RN I replied at 1:26 PM, “Sounds good. Please ask them to fax us a resume order ....”, family replied to RN I at 1:44 PM, “I can be out to see you Monday [10/11/2021] afternoon. Call me over the weekend if you have any questions ....” A document dated and signed by occupational therapist (OT) K on 10/18/2021 at 8:17AM, titled “Missed Visit Note”, for visit date 10/14/2021, stated “... Patient refused service today ... too tired ....” A document dated and signed by RN I on 10/18/2021 at 9:11 AM, titled “Missed Visit Note”, for visit date 10/14/2021, stated “... [family] requested missed visit due to multiple other disciplines visiting today ....” The record evidenced the only visit made by agency staff on 10/14/2021, was by physical therapist (PT) J. A document dated and signed by RN I on 10/19/2021, visit time 12:30 PM – 1:30 PM, titled “... SN [skilled nurse] Visit Note”, indicated the patient did not go to dialysis this date due to fatigue, the nurse assessed “significant decline in respiratory status”, “ patient’s respiratory status declining”, nurse requested for family to transport to ED (emergency department), but family indicated she would take the patient to urgent care. A document dated and signed by occupational therapist K on 10/19/2021, visit time 1:35 PM – 2:20 PM, titled “... OT Eval and CP [care plan]” evidenced the patient’s respirations were regular, the patient was stable, and failed to evidence the patient exhibited any respiratory complications. This visit occurred 5 minutes after the nurse’s visit which indicated the patient had a significant decline. A document dated and signed by RN I on 10/22/2021 titled “... SN Visit Note” evidenced a nursing visit was made from 12:30 PM – 1:00 PM, and indicated RN I notified the physician of the patient’s poor condition. During an interview on 12/08/2021 at 12:52 PM, person I (urgent care H staff) indicated the patient was checked in at the facility on 10/22/2021 at 1:07 PM, and was sent to the ED at 1:35 PM. During an interview on 12/08/2021 at 11:00 AM, the patient’s visit schedule for discipline visits made and/or missed was reviewed with family. When queried about missed visits, family indicated she did not refuse OT or the nurse on 10/14/2021 on behalf of the patient, and there was definitely no nursing visit made on 10/22/2021, because she knew no one was there before she took the patient to urgent care that day. Family’s texts with RN I on 10/22/2021, indicated the family informed RN I at 9:14 AM the patient had a rough night and began vomiting as soon as food “hit her stomach”, the patient was scheduled for dialysis that day, and RN I texted at 11:45 AM, to see if family got in touch with the doctor. A document authenticated/electronically signed on 11/04/2021 at 7:42 PM, by administrator/RN A at 7:42 PM titled “Physician Supplemental Order” stated, “... DC [discharge] PT and OT per patient request, not feeling well ....” Family requested PT and OT to be put on hold 11/10/2021, not 11/04/2021. During an interview on 12/08/2021 at 11:00 AM with family, observed a text from family to RN I on 11/10/2021 at 9:33 AM. which stated, “Can we have Mom’s PT and OT put on hold for now.” A home visit was observed with RN I on 11/18/2021 at 12:55 PM. During this time, RN I assessed a new wound, and informed the family she would “stop by tomorrow” (11/19/2021) with wound supplies. A document dated and signed by RN I on 11/19/2021, titled “... SN Visit Note” evidenced a nursing visit was made from 3:15 PM – 4:00 PM, and vital signs, wound care, and an assessment was completed. During an interview on 12/08/2021 at 11:00 AM, with family, when queried if a nursing visit was made by RN I on 11/19/2021, family stated “... Well she just came in and did the dressing and left ....” When queried if the nurse assessed the patient’s vital signs or anything else, she indicated she didn’t, and she wasn’t there very long. A document dated and signed by RN I on 11/24/2021 at 4:04 PM, titled “Missed Visit Note” stated “... Skilled nursing visit scheduled for today, called to arrange time and daughter ... stated she was going to take the patient to the emergency room for uncontrolled high BP [blood pressure]. No visit today ....”, and indicated administrator/RN A was notified. During an interview on 12/1/2021 at 11:03 AM, when queried when her last nursing visit was with the patient, RN I indicated she saw the patient last Friday (11/26/2021), then recanted and indicated she saw her on 11/24/2021, the patient was “having high blood pressure”, they (hospital D) kept her until Saturday, she had a stent, and family asked her to come tomorrow (12/02/2021). During an interview on 12/08/2021 at 11:00 AM, with family, a text message was observed dated 11/24/2021 at 10:46 AM, from family to RN I ,which stated “Mom’s in the hospital her BP went up to 248/104 so I took her in last night. They admitted her and did an angiogram this morning”. A text dated 11/27/2021 at 10:08 AM, from family to RN I, stated, “Mom is home ....”, and a reply from RN I to family at 4:39 PM which stated “... I’m glad she’s home! Let me know when you want me to come over ....” During an interview on 12/01/2021 at 1:35 PM, when queried if she (family) would have accepted a nursing visit on 12/27/2021, when she texted to let RN I know the patient was home from the hospital, family stated “Yes, of course”. A document received from hospital D on 12/08/2021, titled “Facesheets [sic]” indicated the patient was admitted into the emergency department on 11/23/2021 at 9:21 PM. A hospital document titled “Emergency Documentation” evidenced the patient had a heart attack, stent placement, and was discharged to home on 11/25/2021. An agency document dated 11/24/2021, titled “Physician Supplemental Order” indicated RN I received an order on 11/24/2021, no time was documented, and stated “... Decrease SN visits to 1x [1 time] a week eff [effective] week of 11/24 per patient request ....” The document was not signed by RN I or the physician. During an interview on 12/08/2021 at 3:02 PM, when queried how the EMR (electronic medical record) evidenced when a document was created or modified, clinical manager B indicated she didn’t know, and indicated she would “put in a ticket” to the EMR to find out. During an interview on 12/9/2021 at 12:26 PM, as follow up to the interview conducted on 12/08/2021 at 3:02 PM, clinical manager B indicated the order dated 11/24/2021, to decrease nursing visits to weekly, was actually written by administrator/RN A on 12/7/2021, but entered as RN I. When queried how the patient requested to have her visits decreased when she was in the hospital during that time, experiencing a heart attack, clinical manager B did not respond. 7. Record review for patient #3 was completed on 12/15/2021, start of care date 08/20/2021, certification period 08/20/2021 – 10/18/2021, discharge date 09/24/2021, evidenced a document dated 08/20/2021, and signed by PT J on 08/30/2021, titled “Home Health Certification and Plan of Care” This document indicated PT was ordered once the first week, then 2 times per week for 3 weeks, and all goals projected to be met by 09/08/2021. An agency document dated and signed 09/08/2021, by PT J titled “...PT Re-Eval” evidenced all goals to be met by 09/10/2021. During an interview on 11/30/2021 at 2:00 PM, when queried if the goal dates on the 09/08/2021, were incorrect, the clinical manager indicated they were, and when queried if they should reflect the new frequency of visits for PT, she stated “...Yes.” A document dated 09/08/2021, signed by PT J on 09/12/2021, and physician MM on 09/10/2021, titled “Physician Supplemental Order” evidenced the physician signed the order before the PT did, and PT was to continue twice weekly for two weeks, beginning the week of 09/13/2021. During an interview on 12/9/2021 at 12:26 PM, when queried if an order was signed by a physician without a clinician’s signature, clinical manager B indicated it was built into the EMR that orders couldn’t be sent to the physician until signed by the clinician. 8. Record review for patient #5 was completed on 12/15/2021, start of care date 09/08/2021, and a certification period of 09/08/2021 – 11/06/2021. Record review evidenced a document authenticated/electronically dated and signed by administrator/RN A on 09/08/2021 at 9:55 AM, titled “... Start of Care [comprehensive assessment] ....” This document indicated the comprehensive assessment visit was completed from 1:00 PM – 1:45 PM, but was authenticated prior to the visit. A document authenticated/electronically dated and signed by administrator/RN A on 09/08/2021 at 9:56 AM, titled “Home Health Certification and Plan of Care” indicated the plan of care was created prior to the occurrence of the comprehensive assessment. 9. Record review for patient #6 was completed on 12/15/2021, start of care 08/31/2020, and a certification period of 10/25/2021 – 12/23/2021. Record review evidenced a document authenticated/electronically dated and signed by RN I on 10/22/2021 at 6:11 PM, titled “... Recertification [comprehensive assessment] ....” This document indicated the comprehensive reassessment visit was completed from 10:00 PM – 10:45 PM, but was authenticated prior to the visit. An agency document authenticated/electronically dated and signed by RN I on 10/21/2021 at 6:11 PM, titled “Home Health Certification and Plan of Care” indicated the plan of care was created 1 day prior to the occurrence of the comprehensive reassessment. An agency document dated 12/06/2021, titled “...SN Visit Note” was received on 12/09/2021. This document indicated a nursing visit was made by LPN E on 12/06/2021, and failed to evidence the nurse authenticated/electronically dated and signed or completed any documentation related to the visit. 10. Record review for patient #7 was completed on 12/15/2021, start of care date 7/2/2021, with a certification period of 10/30/2021 – 12/28/2021. Record review evidenced a document dated and signed by LPN E on 11/26/2021, titled “Missed Visit Note”, which stated, “... Patient Hospitalized ... Patient taken by ambulance ... just prior to this author’s arrival ....” The document indicated the agency and administrator/RN A was notified on 11/27/2021, and the ALF notified the physician on 11/27/2021. A document dated and signed by administrator/RN A on 11/26/2021 at 8:11 PM, titled “Physician Supplemental Order”, stated “... Status Report with Comments and Notes ... Hold all home health services as the patient was admitted to the hospital ....” The document was authenticated/electronically dated and signed 1 day before administrator/RN A was notified the patient was hospitalized. A document received on 12/09/2021, dated 12/06/2021, titled “...SN Visit Note”. This document evidenced a nursing visit was made by LPN E on 12/06/2021, and failed to evidence the nurse authenticated/electronically dated and signed or completed any documentation related to the visit. An agency document titled “Physician Supplemental Order (Resume Care Orders)” indicated an order was received on 12/03/2021, RN I requested the order, and failed to evidence RN I authenticated/electronically dated and signed the document. 11. Record review for patient #9 was completed on 12/15/2021, start of care 04/30/2021, and a certification period of 04/30/2021 – 06/28/2021, transfer/discharge date 05/08/2021. Record review evidenced a document authenticated/electronically dated and signed by administrator/RN A on 04/30/2021 at 7:24 AM, titled “... Start of Care ....” This document indicated the comprehensive assessment visit was completed from 3:44 PM – 4:29 PM, but was authenticated prior to the visit. An agency document authenticated/electronically dated and signed by administrator/RN A on 04/30/2021 at 7:24 AM, titled “Home Health Certification and Plan of Care” evidenced the plan of care was created prior to the occurrence of the comprehensive assessment. 12. Record review for patient #10 was completed on 12/15/2021, start of care date 11/07/2021, and certification dates of 11/07/2021 – 01/05/2022. Record review evidenced a document received on 12/09/2021, dated 1/01/2022, titled “... Resumption of Care ....” which indicated RN I performed a visit on 12/01/2021, and failed to evidence the nurse authenticated/electronically dated and signed or completed the documentation related to the visit. An agency document titled “Physician Supplemental Order (Resume Care Orders)”, received on 12/09/2021, evidenced an order was received on 12/01/2021, RN I requested the order, and failed to evidence RN I authenticated/electronically dated, signed, or completed the document. 13. Record review for patient #11 was completed on 12/15/2021, start of care date 12/07/2021, and certification dates 12/07/2021 – 02/04/2022. The clinical record was requested and received on 12/13/2021 at 11:20 AM, and evidenced a document was received on 12/13/2021 at 11:20 AM, dated 12/09/2021, titled “... SN Visit Note”, which indicated a nursing visit was made by administrator/RN A from 10:00 PM – 10:45 PM, and failed to evidence administrator/RN A authenticated/electronically dated and signed or completed any documentation related to the visit. During an interview on 12/13/2021 at 11:25 AM, when queried if her visit note was completed for 12/09/2021, administrator/RN A stated “Nope, I’m not done ....” When queried what wound care she performed on the patient during that visit, administrator/RN A stated, “At that time I just did the calmoseptine and adhesive dressing until I spoke to [FNP (family nurse practitioner) C] to get [new] orders ....” When queried if the visit was made at night from 10:00 PM – 10:45 PM, administrator/RN A stated, “I have no idea ....” When queried if the new wound care orders were implemented since receipt of the order on 12/09/2021, administrator/RN A stated, “... She’s being seen today, so today it will start ....” When queried for clarification that the new wound care was ordered on 12/09/2021, and 12/13/2021 would be the first time it was implemented, administrator/RN A stated “Yes ... this is the first visit after it was ordered.” A document received on 12/13/2021 at 11:20 AM, titled “Physician Supplemental Order” evidenced an order was received on 12/09/2021, was authenticated/electronically dated and signed by administrator/RN A on 12/09/2021 at 3:23 PM, and stated, “... apply aquacel ... to wound bed ....” During an interview on 12/14/2021 at 11:51 AM, administrator/RN A recanted her statement made on 12/13/2021 at 11:25 AM, that she just did the calmoseptine and adhesive dressing until she spoke to FNP C to get orders, indicated she implemented the physician order the day it was received (12/09/2021), and stated “... Yes, I’m changing my answer ... I can’t remember what I do on everybody ....” A document received on 12/14/2021 at 11:54 AM, authenticated/electronically dated and signed 12/09/2021 at 4:30 PM by administrator/RN A, titled “... SN Visit Note” evidenced a nursing visit occurred from 3:00 PM – 4:00 PM. By administrator/RN A’s own admission, the note was not completed as of 12/13/2021 at 11:25 AM, but her signature and authentication date was 12/09/2021. The document indicated she performed the wound care based on the order received on 12/09/2021, not calmoseptine as originally ordered. A home visit was observed at ALF (assisted living facility) K on 12/15/2021 at 10:06 AM, with administrator/RN A, RN G, and surveyor P also present. Observed a communication book at the nurses’ station which included agency documents titled “Assisted Living Visit Coordination Note” for dates 12/07/2021 and 12/13/2021, and failed to evidence a note for 12/09/2021. During this time, when queried if a note for 12/09/2021, was in the book, administrator/RN A indicated it should have been, she had a picture on her phone, they (ALF K staff) lost them a lot, and when requested, surveyor observed a picture of the note on her phone. When queried to observe the picture properties, administrator/RN A stated, “Sure ....”, and produced the properties, which evidenced the photo was taken on 12/09/2021 at 11:20 AM, prior to the documented times the visit occurred on 12/09/2021. During an interview on 12/15/2021 at 12:45 PM, a document was received at 12:46 PM, which was a printed copy of the picture taken by administrator/RN A on 12/09/2021, titled “Assisted Living Visit Coordination Note”. When queried if the document was completed after her visit on 12/09/2021 (picture taken 12/09/2021 at 11:20 AM), administrator/RN A stated “Yes.” When queried how it was created after the visit, as she documented the visit occurred from 3:00 PM – 4:10 PM, administrator/RN A stated “ I probably mixed up the times ... I was there all afternoon ... I saw a lot of patients ....” An agency document received on 12/14/2021 at 11:48 AM, authenticated/electronically dated and signed 12/13/2021, by RN G titled “Physician Supplemental Order” evidenced antibiotics and ensure nutritional supplement were ordered. During an interview on 12/14/2021 at 11:51 PM, the EMR evidenced the order was edited on 12/14/2021, and failed to evidence the edit, or date/time of edit. When queried why the date wasn’t updated, administrator/RN A and clinical manager B both indicated they didn’t know. When queried what was edited, clinical manager B indicated she didn’t know, and administrator/RN A stated, “She added the ensure on there I assume ....” 17-15-1(a)(7)