Every finding on record at Eh Home Health of the Midwest, LLC

This visit was for a Federal and State complaint survey of a Home Health Provider. Survey Dates: 02/10/2026 and 02/11/2026 Unduplicated skilled admissions last 12 months: 1009 Complaint #2711331 was investigated with related deficiencies cited. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Refer to State Form for additional State Findings. Abbreviations used in report: Plan of Care (POC), Start of Care (SOC), Comprehensive Assessment (CA), Registered Nurse (RN), Physical Therapist (PT), and Occupational Therapist (OT). QR: A 1

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the new practitioner was consulted in order to approve of the existing plan of care in 1 of 1 clinical record reviews of patients who changed providers within the first 60 days of service. (Patient 1) Findings include: A clinical record review for Patient 1 evidenced two POC’s, each signed by two different practitioners. The record failed to evidence when the most recent practitioner took over care for Patient 2 or when the initial practitioner ceased to care for Patient 2. The record failed to evidence documentation that the current practitioner approved of or agreed to continue the initial POC that was developed with the initial practitioner. During an interview on 02/11/2026 beginning at 3:44 PM, the Administrator indicated that she believed the current practitioner took over care of Patient 2 on 12/17/2025. The administrator indicated that there was no documentation of the current practitioner agreed to continue the initial POC.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure services were provided only as ordered by a physician in 1 of 2 active clinical records reviewed. (Patient #3) The findings include: A clinical record review for Patient #3 evidenced a physician order dated 12/23/2025 which indicated PT services were placed on hold due to a suspected deep tissue injury (deep tissue damage that could evolve into a severe open wound) on the left heel. The record indicated PT services were provided without an order on 01/02/2026, 01/05/2026, 01/12/2026, and 01/20/2026. On 02/11/2026 at 3:10 PM, the Administrator indicated there was no signed physician order for PT services provided beginning 01/02/2026 through 01/20/2026. 410 IAC 17-13-1(a)

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated with the assessing therapist in 4 of 4 clinical records reviewed. (Patient #1, 2, 3, 4) The findings include: 1. A clinical record review for Patient #3 evidenced an initial PT evaluation completed by PT 1 dated 11/26/2025 which indicated the PT frequency was to be 2 times a week for 6 weeks and 1 time a week for 3 weeks. A physician order dated 11/26/2025 indicated the PT frequency was changed to 2 times a week for 2 weeks and 1 time a week for 7 weeks. An initial OT evaluation by OT 1 dated 12/15/2025 indicated the OT frequency was to be 1 time a week for 4 weeks. A physician order dated 12/15/2025 indicated the OT frequency was changed to 1 time a week for 6 weeks. The record failed to evidence care coordination with PT 1 and OT 1 regarding the frequency change and what the change was in the assessment to warrant the change in frequency. On 02/11/2026 beginning at 2:57 PM, the Administrator indicated there was no documentation in the record the agency notified PT 1 and OT 1 of the frequency changes. A physician order dated 12/23/2025 indicated PT services were placed on hold due to a suspected deep tissue injury (deep tissue damage that could evolve into a severe open wound) on the left heel. The record indicated PT services were provided without an order on 01/02/2026, 01/05/2026, 01/12/2026, and 01/20/2026. The record failed to evidence care coordination with the PT and PTA regarding the hold for PT services. On 02/11/2026 at 3:10 PM, the Administrator indicated there was no care coordination with the PT and PTA regarding the hold for PT services. 2. A clinical record review for Patient #4 evidenced an initial OT evaluation completed by OT 1 dated 12/15/2025 which indicated the OT frequency was to be 1 time a week for 6 weeks. A physician order dated 12/15/2025 indicated the OT frequency was changed to 1 time a week for 8 weeks. An initial PT evaluation completed by PT 2 dated 12/06/2025 indicated the PT frequency was to be 2 times a week. The POC for the initial certification period 12/06/2025-02/03/2026 indicated the PT frequency was 1 time a week for 9 weeks. The record failed to evidence care coordination with PT 2 and OT 1 regarding the frequency change and what the change was in the assessment to warrant the change in frequency. On 02/11/2026 beginning at 3:18 PM, the Administrator indicated there was no documentation in the record the agency notified PT 2 and OT 1 of the frequency changes. 3. On 02/11/2026 beginning at 12:23 PM, PT 1 indicated he/she was unsure how orders were changed related to the PT frequency and indicated there is no communication from the agency related to frequency change. PT 1 indicated after the therapy evaluation is completed and the therapist determine the visit frequency, the frequency that is actually provided to patient is determined by an Artificial Intelligence (AI) recommendation on the “back end” by administration. 4. On 02/11/2026 beginning at 1:01 PM, OT 1 indicated he/she was not sure why the difference in frequency from the initial assessment and the ordered frequency. 5. On 02/11/2026 at 2:21 PM, the Administrator indicated the frequency should be based on the clinician’s assessment. The Administrator indicated the agency utilized PULSE which was an AI program based on thousands of medical records which the agency used as an analytic tool to give recommended frequencies based on patients with similar diagnoses and assessments. The Administrator indicated if the PULSE recommended frequency was different than the clinician’s frequency based on assessment, the agency would ask the clinician to provide additional documentation to support their assessed frequency. The Administrator indicated she can change the frequency of visits in the scheduling program which auto-populates onto the POC and/or physician order. 1.A clinical record review for Patient 1 evidenced a CA, dated 11/05/2025, by OT 1, that indicated an Occupational Therapy frequency of once weekly for 4 weeks for the certification period of 11/05/2025 to 01/03/2026. A Physician Order, dated 11/06/2025, electronically signed by OT 1 and the Administrator, indicated an Occupational Therapy Frequency of once weekly for 1 week. The record evidenced a CA, dated 12/30/2025, by PT 1, that indicated a Physical Therapy frequency of once weekly for 4 weeks. A POC for the certification period 01/04/2026 to 03/04/ 2026 indicated a Physical Therapy frequency of once weekly for 3 weeks, then twice weekly for 1 week. 2.A clinical record review for Patient 2 evidenced a CA, dated 12/11/2025, by PT 1, that indicated a Physical Therapy frequency of once weekly for 8 weeks for the certification period of 12/11/2025 to 02/08/2026. A Physician Order, dated 12/11/2025, electronically signed by PT 1 and the Administrator, indicated a Physical Therapy frequency of once weekly for 9 weeks. The record evidenced a CA, dated 12/16/2025, by OT 1, that indicated an Occupational Therapy frequency of once weekly for 6 weeks for the certification period of 12/11/2025 to 02/08/2026. A Physician Order, dated 12/16/2025, electronically signed by OT 1 and the Administrator, indicated an Occupational Therapy frequency of once weekly for 7 weeks. 3.During an interview on 02/11/2025 beginning at 2:30 PM, the Administrator indicated that visit frequencies are often changed due when Pulse (and artificial intelligence tool used by the agency) reviews patient information and suggests an alternate frequency. The Administrator indicated that there was no documentation that the staff assigned to Patient 1 or Patient 2 was aware of the change in frequency from the CA’s.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure care was coordinated with the patient in 4 of 4 clinical records reviewed. (Patient #1, 2, 3, 4) The findings include: 1. A clinical record review for Patient #3 evidenced an initial PT evaluation completed by PT 1 dated 11/26/2025 which indicated the PT frequency was to be 2 times a week for 6 weeks and 1 time a week for 3 weeks and indicated PT 1 informed Patient of the PT POC. A physician order dated 11/26/2025 indicated the PT frequency was changed to 2 times a week for 2 weeks and 1 time a week for 7 weeks. An initial OT evaluation by OT 1 dated 12/15/2025 indicated the OT frequency was to be 1 time a week for 4 weeks and indicated OT 1 informed Patient of the OT POC. A physician order dated 12/15/2025 indicated the OT frequency was changed to 1 time a week for 6 weeks. A Home Health Change of Care Notice signed and dated by Patient on 11/26/2025 indicated the PT frequency was 2 times a week for 6 weeks and 1 time a week for 3 weeks. The record failed to evidence care coordination with Patient regarding the frequency change. On 02/11/2026 beginning at 12:23 PM, PT 1 indicated the PT frequency discussed with Patient was 2 times a week for 6 weeks and 1 time a week for 3 weeks and did not discuss the change in PT frequency with Patient since PT 1 was unaware of the frequency change. On 02/11/2026 beginning at 2:57 PM, the Administrator indicated there was no documentation in the record the agency notified Patient of the change in PT and OT frequency. 2. A clinical record review for Patient #4 evidenced an initial OT evaluation completed by OT 1 dated 12/15/2025 which indicated the OT frequency was to be 1 time a week for 6 weeks and indicated OT 1 informed Patient of the OT POC. A physician order dated 12/15/2025 indicated the OT frequency was changed to 1 time a week for 8 weeks. An initial PT evaluation completed by PT 2 dated 12/06/2025 indicated the PT frequency was to be 2 times a week and indicated PT 2 informed Patient of the PT POC. The POC for the initial certification period 12/06/2025-02/03/2026 indicated the PT frequency was 1 time a week for 9 weeks. The record failed to evidence care coordination with Patient regarding the frequency change. On 02/11/2026 beginning at 3:18 PM, the Administrator indicated there was no documentation in the record the agency notified Patient of the frequency changes. 3. On 02/11/2026 beginning at 1:01 PM, OT 1 indicated the frequency determined at tine of the evaluation was the frequency discussed with the patients. 1.A clinical record review for Patient 1 evidenced a CA, dated 11/05/2025, by OT 1, that indicated an Occupational Therapy frequency of once weekly for 4 weeks for the certification period of 11/05/2025 to 01/03/2026. A Physician Order, dated 11/06/2025, electronically signed by OT 1 and the Administrator, indicated an Occupational Therapy Frequency of once weekly for 1 week. The record evidenced a CA, dated 12/30/2025, by PT 1, that indicated a Physical Therapy frequency of once weekly for 4 weeks. A POC for the certification period 01/04/2026 to 03/04/2026 indicated a Physical Therapy frequency of once weekly for 3 weeks, then twice weekly for 1 week. The record failed to evidence documentation that Patient 1 was notified of the change in OT and PT frequency 2. A clinical record review for Patient 2 evidenced a CA, dated 12/11/2025, by PT 1, that indicated a Physical Therapy frequency of once weekly for 8 weeks for the certification period of 12/11/2025 to 02/08/2026. A Physician Order, dated 12/11/2025, electronically signed by PT 1 and the Administrator, indicated a Physical Therapy frequency of once weekly for 9 weeks. The record evidenced a CA, dated 12/16/2025, by OT 1, that indicated an Occupational Therapy frequency of once weekly for 6 weeks for the certification period of 12/11/2025 to 02/08/2026. A Physician Order, dated 12/16/2025, electronically signed by OT 1 and the Administrator, indicated an Occupational Therapy frequency of once weekly for 7 weeks. The record failed to evidence that Patient 2 was notified of the change in PT and OT frequency. 3.During an interview on 02/11/2025 beginning at 3:30 PM, the Administrator indicated that there was not documentation that Patient 1 or Patient 2 was notified of the change in frequencies.

An Emergency Preparedness Survey was conducted by the Indiana Department of Health in accordance with 42 CFR 484.102. Survey Dates: 8/9/2023 – 8/11/2023 Census: 80 At this Emergency Preparedness survey, Enhabit Home Health and Hospice was found in substantial compliance with Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 484.102.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to develop a comprehensive emergency preparedness program individualized to the agency. The findings include: Record review on 8/10/2023, of the agency’s emergency preparedness binder evidenced information and resources for multiple different states where agencies are a part of Entity A corporation. Record review failed to evidence a communication plan to include a method for sharing clinical information with other healthcare providers. Record review failed to evidence a plan for occupancy needs with other healthcare providers. Record review failed to evidence a plan to use volunteers or other emergency staffing. During an interview on 8/11/2023, from 9:35 AM – 10:27 AM, the Administrator indicated the agency did not use volunteers. The Administrator could not identify a communication plan for sharing clinical information or a plan for occupancy needs with other healthcare providers.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the home health agency failed to ensure all patients had an individualized emergency preparedness plan in the home for 4 of 4 home visits conducted (Patient #1, 2, 5, 6). The findings include: *. An observation of a home visit was conducted on 8/10/2023, from 10:35 AM – 11:10 AM, for Patient #1 with RN 2. During the home visit, the patient’s admission folder was reviewed for the required individualized emergency preparedness plan. Review of the home folder failed to evidence individualized emergency preparedness information to include an evacuation location, pharmacy and physician contact information, and medical equipment needed daily. Observation failed to evidence an emergency preparedness plan was maintained in the patient’s home. On 8/11/2023, at 5:33 PM, the Administrator was informed the patient lived with the relative named as the emergency evacuation address, contact information for the patient’s physician, pharmacy, the local police and fire departments, and any medical equipment the patient would need in an emergency. *. An observation was conducted on 8/10/2023, from 12:57 PM – 1:57 PM, for Patient #2, with PT 1. During the home visit, the patient’s admission folder was reviewed for required information and failed to evidence individualized emergency preparedness information to include an evacuation location, pharmacy information, and medical equipment needed daily. Observation failed to evidence an emergency preparedness plan was maintained in the patient’s home. During an interview on 8/10/2023, at 1:45 PM, PT 1 indicated Emergency Preparedness is reviewed with the patient verbally and all individualized information would be documented in the system. *. During an interview on 8/11/2023, at 9:55 AM, the Administrator indicated the individualized emergency preparedness plan was created at the start of care included in the admission packet and the patient’s triage code was documented in the electronic health record. 1. During an observation of care at the home of Patient #5, on 8/10/2023, at 2:26 PM, the agency’s patient folder was observed. Review of the packet failed to evidence an individualized emergency plan. Clinical record review on 8/10/2023, failed to evidence an individualized emergency plan. During an interview on 8/10/2023, at 4:01 PM, the Clinical Manager indicated there was not an individualized emergency plan for the patient. 2. During an observation of care at the home of Patient #6, on 8/11/2023, at 9:00 AM, the agency’s patient folder was observed. Review of the packet failed to evidence an individualized emergency plan. Clinical record review on 8/10/2023, failed to evidence an individualized emergency plan.

This visit was for a Federal Recertification and State re-licensure survey of a home health provider. Survey Date: August 9-11, 2023 Unduplicated Skilled Admissions for the last 12 Months: 328 Facility ID: 004608 Survey was fully extended on 8/10/2023. During this Federal Recertification Survey, Enhabit Home Health was found to be out of compliance with Conditions of Participation 42 CFR §484.50 Patient Rights; and 42 CFR §484.105 Organization and Administration of Services. Based on the Condition-level deficiencies during the 8/11/2023 survey, Enhabit Home Health was subject to an extended survey pursuant to section 1891(c)(2)(D) of the Social Security Act on 6/27/2023. Therefore, and pursuant to section 1891(a)(3)(D)(iii) of the Act, your agency is precluded from operating or being the site of a home health aide training, skills competency and/or competency evaluation programs for a period of two years beginning 8/11/2023 and continuing through 8/10/2025. This deficiency report reflects State Findings cited in accordance with 410 IAC 17. Quality Review Completed 08/22/2023, Area 1

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 record review and interview, the agency failed to protect and promote the exercise of patient rights as follows: the agency failed to provide patients with the name and contact information of the administrator in order to receive complaints (see tag G0414); the agency failed to ensure the patients participated in, were informed about, and consented to care in advance of services and treatments with respect to the disciplines that will furnish the care (see tag G0434); the agency failed to ensure the patient had the right to a confidential record (see tag G0438); and the agency failed to ensure the patients were discharged when goals and measurable outcomes were achieved (see tag G0458). The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.50 Patient Rights.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to provide the patients the name and contact information of the administrator in order to receive complaints in 2 of 4 home visits. (Patients #5, 6) The findings include: 1. Review of the agency’s admission packet/folder on 8/9/2023, failed to evidence the name of the administrator. 2. During an observation of care at the home of Patient #5 on 8/10/2023, at 2:26 PM, the agency folder was observed but the medication list and name of the administrator were not observed in the patient’s home. 3. During an observation of care at the home of Patient #6 on 8/11/2023, at 8:57 AM, the agency folder was observed but the medication list and name of the administrator were not observed in the patient’s home. 4. During an interview on 8/11/2023, at 4:35 PM, the Administrator indicated the name of the administrator was included on the medication list that was printed and taken to the patient’s home.

Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patients participated in, were informed about, and consented to care in advance of services and treatments with respect to the disciplines that will furnish the care in 7 of 7 active clinical records reviewed (Patient #1, 2, 3, 4, 5, 6, 7). The findings include: *. Clinical record review on 8/10/2023, for Patient #1, start of care 7/21/2023, evidenced an agency document titled “Service Agreement” signed by RN 3, indicated the discipline providing services was skilled nursing which would come once a week for 9 weeks. Record review evidenced skilled nursing, physical therapy and occupational therapy services began on 7/21/2023. Review failed to evidence therapy services were reviewed with the patient on the service agreement document. Record review failed to evidence the patient was made aware of changes to the disciplines from the service agreement. *. Clinical record review on 8/11/2023 for Patient #2, start of care 7/18/2023, evidenced an agency document titled “Service Agreement” signed by RN 3, indicated the discipline providing services was skilled nursing once a week for 2 weeks. Record review evidenced PT services were ordered at the start of care. Review failed to evidence therapy services were reviewed with the patient on the service agreement document. Record review failed to evidence the patient was made aware of changes to the disciplines from the service agreement. *. Clinical record review on 8/11/2023, for Patient #3, start of care 7/11/2023, evidenced an agency document titled “Service Agreement” signed by RN 3, stated the frequency for the discipline providing services was twice a week. Review failed to evidence therapy services were reviewed with the patient on the service agreement document. This document failed to evidence the discipline and duration of the services provided. Record review evidenced SN, PT, and OT services were ordered on 7/11/2023. Record review failed to evidence the patient was made aware of the services provided by the agency. *. Clinical record review on 8/10/2023, for Patient #4, start of care 3/16/2023, evidenced an agency document titled “Service Agreement” signed by PT 2, indicated frequencies for the discipline providing services twice a week for 3 weeks, once a week for 5 weeks and OT to evaluate. This document failed to evidence which discipline would come twice a week for 3 weeks and once a week for 5 weeks. Record review evidenced the patient received skilled nursing services to provide catheter assistance. Record review failed to evidence the patient was made aware of all services provided at the start of care. Record review failed to evidence the patient was made aware of changes to the disciplines from the service agreement. *. During an interview on 8/11/2023, at 4:48 PM, the Administrator indicated the agency’s interpretation of their document would only have frequencies for the clinician filling out the form. 1. Clinical record review on 8/9/2023, for Patient #5, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/3/2023-10/1/2023, which indicated the patient was to receive physical therapy (PT) and occupational therapy (OT). Review of an agency document titled “Service Agreement” signed and dated by the patient on 8/3/2023, failed to indicate the disciplines that were to furnish care. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated the patient was to receive skilled nursing, PT, and OT services. Review of an agency document titled “Service Agreement” signed and dated by the patient on 7/27/2023, failed to indicate the disciplines that were to furnish care. 3. Clinical record review on 8/10/2023, for Patient #7, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/26/2023-8/24/2023, which indicated the agency was to provide skilled nursing, physical therapy (PT), and occupational therapy (OT). Review of an agency document titled “Service Agreement” dated 12/28/2022 and documented as verbally consented to by the patient, failed to indicate the disciplines that were to furnish care.

Have a confidential clinical record CFR(s): 484.50(c)(6) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient had the right to a confidential record in 7 of 7 active clinical records reviewed. (Patients #1, 2, 3, 4, 5, 6, 7) The findings include: *. Clinical record review on 8/10/2023, for Patient #1, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/21/2023 – 9/18/2023, which indicated Corporate Staff 3’s electronic signature. *. Clinical record review on 8/11/2023 for Patient #2, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/18/2023 – 9/15/2023, which indicated Corporate Staff 3’s electronic signature. *. Clinical record review on 8/11/2023, for Patient #3, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/11/2023 – 9/8/2023, which indicated Corporate Staff 3’s electronic signature. During an interview on 8/11/2023, at 4:53 PM, Administrator on speakerphone with Corporate Staff 2 who indicated they were in Patient #3’s clinical record. *. Clinical record review on 8/10/2023, for Patient #4, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/14/2023 – 9/11/2023, which indicated Corporate Staff 3’s electronic signature. 1. Clinical record review on 8/9/2023, for Patient #5, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/3/2023-170/1/2023, which indicated Corporate Staff 3’s electronic signature. Review evidenced a document from Entity 2 for Patient #11 scanned into the clinical record of Patient #5. During an interview on 8/10/2023, at 3:57 PM, the Clinical Manager indicated the document was filed in error into the wrong patient’s record. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated Corporate Staff 3’s electronic signature. 3. Clinical record review on 8/10/2023, for Patient #7, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/26/2023-8/24/2023, which indicated Corporate Staff 3’s electronic signature. 4. During an interview on 8/10/2023, at 3:39 PM, the Administrator indicated Corporate Staff 3 had access to the agency’s plans of care and did quality review for the agency. The Administrator indicated Corporate Staff 3 was not a direct or contracted employee of the agency and was an employee of Entity A.

Outcomes/goals have been achieved CFR(s): 484.50(d)(3) The transfer or discharge is appropriate because the physician or allowed practitioner, who is responsible for the home health plan of care and the HHA agree that the measurable outcomes and goals set forth in the plan of care in accordance with §484.60(a)(2)(xiv) have been achieved, and the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the patient no longer needs the HHA's services; This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patients were discharged when goals and measurable outcomes were achieved in 1 of 1 closed record reviewed due to goals met. (Patient #9) The findings include: Clinical record review on 8/11/2023, for Patient #9, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/28/2023-7//26/2023, which indicated the patient was to receive physical and occupational therapy. Review indicated the patient’s goals included, but were not limited to, would remain safe in his/her environment. Review indicated the patient would be discharged when the goals were met or skilled services were no longer needed. Review evidenced an agency document titled “Discharge Summary” dated 7/24/2023, which indicated the patient was discharged due to goals met. Review of an agency document titled “Visit Note Report” completed by the physical therapist (PT) and dated 7/24/2023, indicated the patient was discharged due to the patient progressed to meet intervention goals. Review indicated the patient’s goals for tub/shower transfer, toilet transfer, and level surface gait with walker were not met. Review on 8/9/2023 of an agency document titled “QI [quality improvement] Event Report” evidenced the patient had 5 falls on 4/1/2023, 4/6/2023 x 2, 5/15/2023, and 6/8/2023. During an interview on 8/11/2023, at 1:43 PM, the patient’s caregiver indicated the patient still needed physical therapy and the patient had fallen 2 times in the last few days. During an interview on 8/11/2023, at 2:43 PM, the Clinical Manager indicated if the patient’s goals were not met, the patient should not have been discharged.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the comprehensive assessment included a review of the patient’s medications to identify any potential adverse effects and drug reactions in 3 of 5 clinical records reviewed with only 1 certification period. (Patient #1, 5, 6) The findings include: *. Clinical record review on 8/10/2023, for Patient #1, evidenced an agency document indicated to be the start of care comprehensive assessment completed by RN 3 on 7/21/2023. This document indicated a medication reconciliation was performed at the start of care for 13 medications and reported no medication interactions. Record review of an internet resource (www.medscape.com) to check medication interactions for the patient’s 13 medications evidenced 26 medication interactions, which included 2 serious interactions between Aspirin (over the counter non-steroidal anti-inflammatory drug and anti-platelet/blood thinner) and Ibuprofen (over the counter non-steroidal anti-inflammatory drug), a serious interaction between Carbamazepine (anticonvulsant) and Simvastatin (medication used to treat high cholesterol), and a serious interaction between Carbamazepine and Losartan (used to treat high blood pressure). Record review failed to evidence any interactions were identified in the medication reconciliation. During an interview on 8/10/2023, at 4:18 PM, the Administrator did not identify medication interactions notifications in the coordination notes. *. During an interview on 8/10/2023, at 4:16 PM, the Administrator indicated any medication interactions were sent to their computer to approve via the coordination notes in the patient’s electronic health record. 1. Clinical record review on 8/9/2023, for Patient #5, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by Physical Therapist (PT) 1 and dated 8/3/2023, which indicated the patient’s medications included, but were not limited to, aspirin (a medication used to treat pain, fever, and/or to prevent blood clots), nebivolol (a medication used to treat high blood pressure), diclofenac (a medication used to treat pain and/or inflammation), omeprazole (a medication used to treat reflux), ferrous sulfate (an iron supplement), and Lasix (a medication used to treat fluid retention). Review of medication interactions on Medscape.com on 8/10/2023, indicated moderate medication interactions between aspirin and nebivolol causing a decrease in the effects of nebivolol; omeprazole and ferrous sulfate by causing an increase in stomach acid which can lead to a decrease in the effect of ferrous sulfate; and aspirin and diclofenac causing an increase in risk of bleeding. Record review failed to evidence the potential interactions between aspirin and nebivolol; omeprazole and ferrous sulfate; and aspirin and diclofenac. During an interview on 8/10/2023, at 4:16 PM, the Clinical Manager indicated the electronic medical record program alerted the agency to 3 of the potential interactions but not to moderate interactions between aspirin and nebivolol; omeprazole and ferrous sulfate; and aspirin and diclofenac. The Clinical Manager indicated she would contact the IT department for the electronic medical record to inquire on why not all the potential interactions were alerted. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by the Alternate Clinical Manager/registered nurse (RN) and dated 7/27/2023, which indicated the patient’s medications included, but were not limited to, doxycycline (antibiotic) and amoxicillin-potassium clavulanate (antibiotic). Review of medication interactions on Medscape.com on 8/10/2023, indicated a serious medication interaction between doxycycline and amoxicillin-potassium clavulanate which can cause a decreased therapeutic effect of the amoxicillin. Record review failed to evidence the potential serious interaction between doxycycline and amoxicillin-potassium clavulanate. During an interview on 8/10/2023, at 4:25 PM, the Clinical Manager indicated there were no medication interactions noted for the patient. 3. During an interview at the entrance conference on 8/9/2023, at 10:06 AM, the Clinical Manager indicated the electronic medical record program automatically reviews the medications for potential interactions when the medications are entered into the electronic medical record.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the transfer/discharge summary contained all necessary medical information pertaining to the patient’s current treatment to the receiving facility in 2 of 2 clinical records reviewed with falls. (Patients #8, 9) The findings include: 1. Review on 8/9/2023 of an agency document titled “QI [quality improvement] Event Report” evidenced Patient #8 had 3 falls on 1/29/2023, 2/2/2023, and 2/13/2023 and evidenced Patient #9 had 5 falls on 4/1/2023, 4/6/2023, x 2, 5/15/2023, and 6/8/2023. 2. Clinical record review on 8/11/2023, for Patient #8 evidenced an agency document titled “Discharge Summary” dated 3/7/2023, which failed to evidence the patient’s 3 falls. 3. Clinical record review on 8/11/2023, for Patient #9 evidenced an agency document titled “Discharge Summary” dated 7/26/2023, which failed to include the patient’s falls. 4. During an interview on 8/11/2023, at 2:21 PM, the Clinical Manager indicated the falls were not included in the discharge summary.

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 provide services as directed by the plan of care in 4 of 7 active clinical records reviewed. (Patients #1, 3, 5, 6) The findings include: *. Clinical record review on 8/10/2023, for Patient #1, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/21/2023 – 9/18/2023. An area subtitled “Orders of Discipline and Treatments” stated “… Skilled nurse to review medication profile and reconcile medications as needed. Skilled nurse may instruct and reinforce medication teaching related to use of medications to treat disease processes. Skilled nurse may fill medi-planner per current medication orders/ profile Q week ….” Record review of the medication profile retrieved on 8/9/2023, indicated the patient was prescribed 13 different medications. An observation of a home visit was conducted on 8/2/2023, from 10:35 AM – 11:10 AM, for Patient #1 with RN 2. At 10:43 AM, the patient’s caregiver indicated to RN 2 there was not a medication list in the home. The caregiver indicated they fill the patient’s medi-planner for the morning medications and the patient was independent with their nighttime medications. The caregiver led RN 2 to the bedroom and indicated that was where the patient’s medications were kept on a bedside table. 12 bottled were observed on the table but not picked up to check the labels by RN 2. Observation failed to evidence a medication review was performed as ordered on the plan of care. During an interview on 8/11/2023, at 5:33 PM, when queried how the skilled nurse would observe issues with medication management when the labels were not compared to a medication list, Administrator stated, “I see what you’re saying” and indicated the patient received skilled nursing for medication management. *. Clinical record review on 8/10/2023, for Patient #3, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/11/2023 – 9/8/2023. An area subtitled “Orders of Discipline and Treatments” ordered the skilled nurse to observe and assess skin integrity and to perform wound care treatments. Record review of skilled nurse visit documents from 7/31/2023 and 8/4/2023, failed to evidence complete assessments of all patient wounds to include measurements. Review failed to evidence wound measurements were documented for the patient from 7/24/2023 – 8/10/2023 (17 days). During an interview on 8/11/2023, at 5:19 PM, the Administrator indicated the electronic health record system was not carrying over the documentation of measurements. *. During an interview on 8/11/2023, at 4:51 PM, the Administrator indicated the skilled nurse should measure wounds weekly. 1. Clinical record review on 8/9/2023, for Patient #5, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/3/2023-10/1/2023, which indicated the patient’s primary diagnosis was heart failure and indicated the physical therapist (PT) was to provide education related to heart failure. Review of an agency document titled “Visit Note Report” completed by the PT and dated 8/8/2023, indicated the patient had swelling of both lower extremities. Review failed to evidence the PT educated the patient on interventions for the lower extremity swelling related to the heart failure. During an interview on 8/10/2023, at 3:50 PM, the Clinical Manager indicated the PT should have educated the patient on interventions to include elevating the legs and compliance with medication to reduce swelling. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated the patient’s diagnoses included, but were not limited to, cardiomyopathy (a disease affecting the heart muscle making it more difficult to pump blood around the body) and hypertension (high blood pressure). Review indicated the skilled nurse was to assess co-morbidities including hypertension and other conditions that presented themselves during the course of the episode and intervene to minimize complications. Review indicated the skilled nurse was to change the wound vac (a medical device used to suction drainage from a wound) every Monday and Thursday. Review indicated the PT was to educate the patient on impaired nutritional risk. Review of an agency document titled “Visit Note Report” 8/2/2023, and completed by the skilled nurse, indicated the wound vac dressing was changed on a Wednesday. Review failed to evidence an order prior to the date of the dressing change on 8/2/2023 for the dressing change to be completed on a Wednesday and not on Thursday per the plan of care. Review of an agency document titled “Visit Note Report” completed by the physical therapist assistant (PTA) and dated 8/8/2023, failed to evidence the PTA educated the patient on the impaired nutritional risk per the plan of care. During an interview on 8/10/2023, at 4:42 PM, the Clinical Manager indicated the original order was for wound vac dressing changes to be completed on Mondays and Thursdays and indicated there was an order obtained on 8/9/2023 for dressing changes 3 times a week but not for the dressing that was changed on 8/2/2023. At 4:54 PM, the Clinical Manager indicated she did not see any documentation the PTA educated the patient on the impaired nutritional risk. Review of agency documents titled “Visit Note Report” indicated the patient had 1+ pitting edema (excess fluid of the body causes swelling, and leaving indentation when pressure applied from a grade 1-4 with 1 being the least and 4 being the worst) to both lower extremities on 7/27/2023 as completed by the Alternate Clinical Manager/registered nurse (RN). Document dated 7/28/2023, indicated the patient had 2+ pitting edema to the right lower extremity and document dated 7/31/2023, indicated the patient had 2+ pitting edema to both lower extremities. Review of document completed on 7/29/2023 by the Atlernate Clinical Manager failed to evidence the patient’s lower extremities were assessed for swelling. Review failed to evidence the RN intervened on the increasing edema as directed in the plan of care. During an interview on 8/10/2023 at 1:21 PM, the Alternate Clinical Manager indicated he/she believed the patient was not taking her medications properly which may have attributed to the patient’s edema and did not assess the patient’s lower extremity edema on 7/29/2023, because he/she was more focused on the patient’s wound. During an observation at the patient’s home on 8/11/2023, at 9:00 AM, with RN 1 and the Alternate Clinical Manager, the patient’s lower legs were observed to be red, swollen, and with tight and shiny skin. RN 1 and the Alternate Clinical Manager failed to be observed to have assessed the patient’s vital signs to include blood pressure and failed to be observed listening to the patient’s chest for heart and lung sounds. During an interview on 8/10/2023, at 4:35 PM, the Clinical Manager indicated the RN should have educated the patient on elevating the lower extremities, compliance with medications, and monitoring fluid intake. During an interview on 8/11/2023, at 1:58 PM, the Alternate Clinical Manager indicated they had never seen the patient’s legs that red before and wondered if it was cellulitis (an infection of the skin). The Alternate Clinical Manager indicated the vital signs should be obtained and the heart and lung sounds should be assessed at every visit.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure all orders were incorporated into the plan of care for 1 of 1 active clinical record reviewed where an additional wound developed (Patient #3). The findings include: Clinical record review on 8/11/2023, for Patient #3, start of care 7/11/2023, evidenced a physician’s order from 7/10/2023, for skilled nursing services to provide wound care to the patient’s bilateral heels and coccyx. Record review of an agency document titled “Home Health Certification and Plan of Care” evidenced wound care treatment orders for the right and left heels. Review of the plan of care failed to evidence all wound care orders were incorporated into the plan of care. During an interview on 8/11/2023, at 5:00 PM, Administrator was heard on speakerphone with Corporate Staff 2, who indicated wound care for the coccyx wound should be on the plan of care.

Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to revise the plan of care in 4 of 5 clinical records reviewed who recieved skilled nursing, physical therapy, and occupational therapy. (Patients #3, 4, 6, 7) The findings include: *. Clinical record review on 8/11/2023, for Patient #3, start of care 7/11/2023, evidenced a physicians order from 7/21/2023, for wound care to the right ankle performed 3 times a week. Record review of an agency document titled “Home Health Certification and Plan of Care” evidenced wound care orders for the right and left heels. Record review failed to evidence the plan of care was revised to include the current treatment orders for all wounds. During an interview on 8/11/2023, at 5:22 PM, the Administrator indicated the wound care order for the right ankle was not revised into the plan of care. *. Clinical record review on 8/10/2023, for Patient #4, start of care 3/16/2023, evidenced a physicians order from 7/25/2023, that ordered the patient to take Levaquin (antibiotic), miconazole (antifungal), and changed skilled nurse frequencies to once a week. Record review failed to evidence the plan of care was revised to include current discipline frequencies and treatment orders. During an interview on 8/11/2023, at 5:32 PM, the Administrator indicated the orders from 7/25/2023 were not revised into the plan of care. 1. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated the skilled nurse was to change the wound vac (a medical device used to suction drainage from a wound) every Monday and Thursday. Review of an agency document titled “Physician Order” dated 8/9/2023, indicated the wound vac dressing was to be changed 3 times per week. Review failed to evidence the agency revised the plan of care to reflect the change in wound vac dressing change frequency. During an interview on 8/10/2023, at 4:50 PM, the Clinical Manager indicated the plan of care should have been updated with a new order but it was not. 2. Clinical record review on 8/10/2023, for Patient #7, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/26/2023-8/24/2023, which indicated the agency was to provide skilled nursing services 2 times a week for 8 weeks and then 1 time a week for 1 week. Review of agency documents titled “Physician Order” indicated the patient was to take sulfamethoxazole-trimethoprim (an antibiotic) for a wound infection for 10 days on document dated 6/26/2023. Review of document dated 7/7/2023, indicated the agency was to increase the skilled nursing visits to 3 times a week per document dated 7/7/2023. Review failed to evidence the agency revised the plan of care to reflect the change in skilled nurse frequency and the new antibiotic. During an interview on 8/11/2023, at 3:11 PM, the Clinical Manager indicated the plan of care was not revised.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was notified of a change in the patient’s condition in 2 of 4 clinical records reviewed with wounds. (Patients #6, 7) The findings include: 1. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated the patient’s diagnoses included, but were not limited to, cardiomyopathy (a disease affecting the heart muscle making it more difficult to pump blood around the body) and hypertension (high blood pressure). Review of agency documents titled “Visit Note Report” indicated the patient had 1+ pitting edema (excess fluid of the body causes swelling, and leaving indentation when pressure applied from a grade 1-4 with 1 being the least and 4 being the worst) to both lower extremities on 7/27/2023, as completed by the Alternate Clinical Manager/registered nurse (RN). Document dated 7/28/2023, indicated the patient had 2+ pitting edema to the right lower extremity and document dated 7/31/2023, indicated the patient had 2+ pitting edema to both lower extremities. Review of failed to evidence the agency notified the physician of the increase in edema. During an interview on 8/10/2023, at 4:42 PM, the Clinical Manager indicated the physician should have been notified of the increase in edema and did not see any documentation the physician was notified. 2. Clinical record review on 8/10/2023, for Patient #7, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/26/2023-8/24/2023, indicated Person C was the practitioner responsible for the plan of care. Review of agency documents titled “Visit Note Report” dated 6/30/2023 and 8/9/2023, indicated the wound to the left heel was debrided by Person D. Review failed to evidence the agency notified Person C of the wound debridement to the left foot. During an interview on 8/11/2023, at 3:17 PM, the Clinical Manager indicated she did not see any documentation which indicated Person C was notified of the wound debridement. Review of an agency document titled “Visit Note Report” dated 8/2/2023, indicated the wound to the left heel had soft black necrotic tissue noted, which was a change from previous notes of white tissue. Review failed to evidence the practitioner responsible for the plan of care and Person D, physician providing wound care, were notified of the change in wound status. During an interview on 8/11/2023, at 3:29 PM, the Clinical Manager indicated the clinician should have notified the physician of the black necrotic tissue and did not see documentation that the physician was notified.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to coordinate care in 5 of 10 clinical records reviewed. (Patient #5, 6, 7, 8, 9) The findings include: 1. Review of an undated agency policy on 8/11/2023, titled “Coordination of Services” stated, “… Staff implement actions which reflect coordination, including … Contact with … community agencies, non-agency providers ….” 2. During an observation of care at the residence of Patient #5 at an assisted living facility on 8/10/2023, at 2:45 PM, a document from the assisted living facility titled “Physician’s Orders” was reviewed which indicated the patient’s diet was regular with no added salt. Clinical record review on 8/9/2023, for Patient #5, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 8/3/2023-10/1/2023, which indicated the patient’s diet was heart healthy, low sodium, low cholesterol, low fat, high protein, high calorie diet. During an interview on 8/10/2023, at 3:55 PM, the Clinical Manager indicated clinicians should coordinate care with the assisted living facilities and should notify the physician to clarify any discrepancies. 3. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated the patient’s diagnoses included, but were not limited to, cardiomyopathy (a disease affecting the heart muscle making it more difficult to pump blood around the body) and hypertension (high blood pressure). Review of agency documents titled “Visit Note Report” indicated the patient had 1+ pitting edema (excess fluid of the body causes swelling, and leaving indentation when pressure applied from a grade 1-4 with 1 being the least and 4 being the worst) to both lower extremities on 7/27/2023 as completed by the Alternate Clinical Manager/registered nurse (RN). Document dated 7/28/2023, and completed by the Alternate Clinical Manager, indicated the patient had 2+ pitting edema to the right lower extremity. Document dated 7/29/2023 and completed by the Alternate Clinical Manager failed to evidence an assessment of the lower extremity edema. Review of document completed by Licensed Practical Nurse (LPN) 1 and dated 7/31/2023, evidenced the patient had 2+ pitting edema to both lower extremities. Review failed to evidence any coordination between the Alternate Clinical Manager and LPN 1 regarding the patient’s increased edema and need to notify the physician of the change in status. During an interview on 8/10/2023, at 1:21 PM, the Alternate Clinical Manager indicated she did not call the physician to inform the physician of the patient’s increased edema because she wanted to see how the patient was doing on Monday, 7/31/2023. When queried if she communicated the patient’s change in status regarding the increased edema and need to inform the physician if the edema was not improved on 7/31/2023, the Alternate Clinical Manager indicated she believed she informed LPN 1 to make sure the patient was taking all of her medications. During an interview on 8/10/2023, at 1:32 PM, LPN 1 indicated the Alternate Clinical Manager informed her that the patient had a history of lymphedema (build up of fluid in the soft tissue) but did not provide any further direction. 4. Clinical record review on 8/10/2023, for Patient #7, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 6/26/2023-8/24/2023, which indicated the agency was to provide skilled nursing, physical therapy (PT), and occupational therapy (OT). Review of agency documents titled “Visit Note Report” completed by the licensed practical nurse (LPN) and dated 6/30/2023 and 8/9/2023, indicated the wound was debrided by Person D. Review failed to evidence the LPN notified the RN, PT, and OT of the wound debridement to the left foot. During an interview on 8/11/2023, at 3:17 PM, the Clinical Manager indicated she did not see any documentation indicating the RN, PT, and OT were notified of the wound debridement. 5. Clinical record review on 8/11/2023, for Patient #8, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 1/31/2023-3/31/2023, which indicated the agency provided PT, OT, and speech therapy (ST) services. Review of an agency document titled “Client Occurrence Report” completed by the ST and dated 2/10/2023, evidenced the ST was informed by the caregiver the patient fell resulting in treatment at the emergency room to rule out a concussion. Review failed to evidence the ST coordinated care with the PT and OT regarding the patient’s fall. During an interview on 8/11/2023, at 2:21 PM, the Clinical Manager indicated there was no documentation the PT and OT were notified of the patient’s fall. 6. Clinical record review on 8/11/2023, for Patient #9, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 5/28/2023-7/26/2023, which indicated the agency provided PT and OT services. Review of an agency document titled “Client Occurrence Report” completed by the physical therapy assistant (PTA) and dated 6/8/2023, indicated the patient fell resulting in an abrasion to the right elbow. Review failed to evidence the PTA coordinated care with the PT and the OT regarding the patient’s fall. During an interview on 8/11/2023, at 2:43 PM, the Clinical Manager indicated there was no documentation the PTA coordinated care with the other disciplines regarding the fall.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patient was provided with a written visit schedule including the frequency of visits by agency personnel in 4 of 4 home visits. (Patients #1, 2, 5, 6) The findings include: *. An observation of a home visit was conducted on 8/2/2023, from 10:35 AM – 11:10 AM, for Patient #1 with RN 2. During the home visit, the patient’s admission folder was reviewed for required information and failed to evidence a written visit schedule for all disciplines. A calendar planner was provided to the patient in the admission folder but remained blank. Observation failed evidence a visit schedule for nursing and therapy services was maintained in the patient’s home. On 8/11/2023, at 5:33 PM, the Administrator was informed the calendar planner was completed in the patients home. *. An observation of a home visit was conducted on 8/2/2023, from 12:57 PM – 1:57 PM, for Patient #2, with PT 1. At 1:10 PM, the patient’s admission folder was reviewed for required information and failed to evidence a written visit schedule for all disciplines. A calendar planner was provided to the patient in the admission folder but remained blank. Observation failed evidence a visit schedule for nursing and therapy services was maintained in the patient’s home. 1. During an observation of care at the home of Patient #5 on 8/10/2023, at 2:26 PM, the agency folder was observed but the written visit schedule failed to include the visits to be provided by the occupational therapists. 2. During an observation of care at the home of Patient #6 on 8/11/2023, at 8:57 AM, the agency folder was observed but the written visit schedule was not observed in the patient’s home. 3. During an interview on 8/11/2023, at 4:35 PM, the Clinical Manager indicated the calendar in the planner inside of the agency packet should be completed and left in the patient’s home to inform the patient of their visit schedule.

Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patient was provided with written medication instructions and schedule in 4 of 4 home visits. (Patients #1, 2, 5, 6) The findings include: 4. An observation of a home visit was conducted on 8/2/2023, from 10:35 AM – 11:10 AM, for Patient #1 with RN 2. During the home visit, the patient’s admission folder was reviewed and failed to evidence a medication list with instructions. At 10:43 AM, the patient’s caregiver indicated to RN 2 there was not a medication list in the home. Observation failed evidence a medication list was maintained in the patient’s home. On 8/11/2023, at 5:33 PM, the Administrator was informed the medication list with instructions was not located in the home. 5. An observation of a home visit was conducted on 8/2/2023, from 12:57 PM – 1:57 PM, for Patient #2, with PT 1. During the home visit, the patient’s admission folder was reviewed and failed to evidence a medication list with instructions. Observation failed evidence a medication list was maintained in the patient’s home. 1. During an observation of care at the home of Patient #5 on 8/10/2023, at 2:26 PM, the agency folder was observed but the written medication instructions and schedule failed to be observed in the patient’s home. 2. During an observation of care at the home of Patient #6 on 8/11/2023, at 8:57 AM, the agency folder was observed but the written medication instructions and schedule was not observed in the patient’s home. 3. During an interview on 8/11/2023, at 4:35 PM, the Clinical Manager indicated the medication list should be included in the agency folder in the patient’s home.

Treatments and therapy services CFR(s): 484.60(e)(3) Any treatments to be administered by HHA personnel and personnel acting on behalf of the HHA, including therapy services. This ELEMENT is not met as evidenced by: Based on observation, record review, and interview, the agency failed to ensure the patient was provided with written instruction related to the care and treatments to be provided by the agency in 4 of 4 home visits. (Patient #1, 2, 5, 6) The findings include: 4. An observation of a home visit was conducted on 8/2/2023, from 10:35 AM – 11:10 AM, for Patient #1 with RN 2. During the home visit, the patient’s admission folder was reviewed for required information and failed to evidence a treatment plan for all disciplines. Observation failed evidence a plan of treatment for skilled nursing and therapy services were maintained in the patient’s home. On 8/11/2023, at 5:33 PM, the Administrator was informed of the missing treatment plan in the patient’s home. 5. An observation was conducted on 8/2/2023, from 12:57 PM – 1:57 PM, for Patient #2, with PT 1. During the home visit, the patient’s admission folder was reviewed for required information and failed to evidence a treatment plan for all disciplines. Observation failed evidence a plan of treatment for skilled nursing and therapy services were maintained in the patient’s home. 1. During an observation of care at the home of Patient #5 on 8/10/2023, at 2:26 PM, the agency folder was observed but the written instruction related to the care and treatments to be provided by the agency was not observed in the patient’s home. 2. During an observation of care at the home of Patient #6 on 8/11/2023, at 8:57 AM, the agency folder was observed but the written instruction related to the care and treatments to be provided by the agency was not observed in the patient’s home. 3. During an interview on 8/11/2023, at 4:35 PM, the Clinical Manager indicated the plan of care should be printed and provided to the patient once the plan of care was locked.

Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This ELEMENT is not met as evidenced by: Based on observation, record review and interview, the agency failed to provide the patient and caregiver in writing with the name and contact information of the clinical manager in 4 of 4 home visits conducted. (Patients #1, 2, 5, 6) The findings include: 4. An observation of a home visit was conducted on 8/2/2023, from 10:35 AM – 11:10 AM, for Patient #1 with RN 2. During the home visit, the patient’s admission folder was reviewed for required information and failed to evidence the name of the Clinical Manager. Observation failed evidence contact information for the Clinical Manager was maintained in the patient’s home. On 8/11/2023, at 5:33 PM, the Administrator was informed the patient’s folder did not have a sticker with contact information. 5. An observation was conducted on 8/2/2023, from 12:57 PM – 1:57 PM, for Patient #2, with PT 1. During the home visit, the patient’s admission folder was reviewed for required information and failed to evidence the name of the Clinical Manager. Observation failed evidence contact information for the Clinical Manager was maintained in the patient’s home. 1. During an observation of care at the home of Patient #5 on 8/10/2023, at 2:26 PM, the agency folder was observed but the name and contact information of the clinical manager and the medication list were not observed in the patient’s home. 2. During an observation of care at the home of Patient #6 on 8/11/2023, at 8:57 AM, the agency folder was observed but the name and contact information of the clinical manager and the medication list were not observed in the patient’s home. 3. During an interview on 8/11/2023, at 4:35 PM, the Clinical Manager indicated the name of the clinical manager should be included on the patient’s medication list in the home.

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the quality assessment performance improvement (QAPI) program collected quality indicator data to monitor the effectiveness and quality of care related to wounds for 4 of the active 6 clinical records with skilled nursing services. (Patients #2, 3, 6, 7) The findings include: 1. Clinical record review on 8/11/2023, for Patient #2 indicated the agency provided skilled nursing services for the surgical wound treatment to the left thigh. 2. Clinical record review on 8/11/2023, for Patient #3 indicated the agency provided skilled nursing services for the pressure ulcer (wounds caused by pressure applied to the skin) treatment to the left heel, right ankle, and coccyx (lower back above the buttocks). 3. Clinical record review on 8/10/2023, for Patient #6 indicated the agency provided skilled nursing services for the surgical wound treatment to the left breast. 4. Clinical record review on 8/10/2023, for Patient #7 indicated the agency provided skilled nursing services for the diabetic ulcer (a wound caused by diabetes, a disease affecting the blood sugar) treatment to the left heel. 5. Review of the QAPI program on 8/11/2023, failed to evidence data collected on the wounds and review failed to evidence the governing body approved the frequency and detail of the program’s data collection. 6. During an interview on 8/11/2023, at 3:38 PM, the Clinical Manager indicated patients with wounds were considered high risk and the agency did not collect data on the wounds.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to ensure the performance improvement activities focused on high risk areas as evidenced in 4 of the active 6 clinical records with skilled nursing services. (Patients #2, 3, 6, 7) The findings include: 1. Clinical record review on 8/11/2023, for Patient #2 indicated the agency provided skilled nursing services for the surgical wound treatment to the left thigh. 2. Clinical record review on 8/11/2023, for Patient #3 indicated the agency provided skilled nursing services for the pressure ulcer (wounds caused by pressure applied to the skin) treatment to the left heel, right ankle, right ankle, and coccyx (lower back above the buttocks). 3. Clinical record review on 8/10/2023, for Patient #6 indicated the agency provided skilled nursing services for the surgical wound treatment to the left breast. 4. Clinical record review on 8/10/2023, for Patient #7 indicated the agency provided skilled nursing services for the diabetic ulcer (a wound caused by diabetes, a disease affecting the blood sugar) treatment to the left heel. 5. Review of the QAPI program on 8/11/2023, failed to evidence performance improvement activities for the agency’s wound-related care. 6. During an interview on 8/11/2023, at 3:38 PM, the Clinical Manager indicated patients with wounds were considered high risk and there was nothing about wounds in the quality assessment and performance improvement (QAPI) plan.

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 ensure quality assessment performance improvement (QAPI) activities led to an immediate correction of the patient falls. The findings include: Review on 8/9/2023, of an agency document titled “QI [quality improvement] Event Report” indicated of the 75 incidents from 1/1/2023 to 8/9/2023, 67 were patient falls. Review of the QAPI program on 8/11/2023, indicated there was a trend up in patient falls with 24 falls reported for quarter 2 of 2023 compared to 17 falls reported in quarter 1 of 2023. Review failed to evidence performance improvement actions to address and correct the patient falls. During an interview on 8/11/2023, at 3:38 PM, the Clinical Manager indicated all the QAPI program indicated was a trend up in falls but no specific plan to address the patient falls.

Track adverse patient events CFR(s): 484.65(c)(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions. This STANDARD is not met as evidenced by: Based on record review and interview, the agency failed to analyze the cause and implement preventive actions related to infections. The findings include: Review of an undated agency document titled “Quality Indicator Analysis” on 8/11/2023, identified as the data for Quarter 1, 2023, indicated the agency did not meet the target goal for infections in 6 of the past 12 months and had an increase from 4 infections in March 2023 to 10 infections in April 2023. Review indicated 5 infections were related to skin/wound and 6 infections were related urinary tract infections. Review failed to evidence an analysis of the cause of infections and implementation of preventive actions related to infections. Review of the undated agency document titled “Quality Indicator Analysis” identified as the data for Quarter 2, 2023, the agency did not meet the target goal for infections for 2 of the 3 months for the quarter. Review failed to evidence an analysis of the types and cause of infections and implementation of preventive actions. During an interview on 8/11/2023, at 3:38 PM, the Clinical Manager indicated the agency did not meet the average for infections and did not collect data on the type of infections.

Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This ELEMENT is not met as evidenced by: Based on record review and interview, the skilled professional failed to prepare clinical documentation accurately in 3 of 7 active clinical records reviewed. (Patients #4, 5, 6) The findings include: 3. Clinical record review on 8/10/2023, for Patient #4, start of care 3/16/2023, evidenced an initial comprehensive assessment which indicated the agency planned to discharge the patient to an assisted living facility. Review failed to evidence the patient lived in a facility. During an interview on 8/11/2023, at 5:26 PM, the Administrator indicated the patient lived in a house, not an assisted living facility and stated, “I have to read into this.” 1. Clinical record review on 8/9/2023, for Patient #5, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by Physical Therapist (PT) 1 and dated 8/3/2023, which indicated the patient’s medications included, but were not limited to, aspirin (a medication used to treat pain, fever, and/or to prevent blood clots), nebivolol (a medication used to treat high blood pressure), diclofenac (a medication used to treat pain and/or inflammation), omeprazole (a medication used to treat reflux), ferrous sulfate (an iron supplement), and Lasix (a medication used to treat fluid retention). Review indicated the PT checked no issues were identified during the medication review. Review of agency documents titled “Client Coordination Note Report” dated 8/3/2023 and completed by PT 1 indicated moderate medication interactions between diclofenac and nebivolol; diclofenac and Lasix; and aspirin and Lasix. Review of medication interactions on Medscape.com on 8/10/2023, indicated moderate medication interactions between aspirin and nebivolol causing a decrease in the effects of nebivolol; omeprazole and ferrous sulfate by causing an increase in stomach acid which can lead to a decrease in the effect of ferrous sulfate; and aspirin and diclofenac causing an increase in risk of bleeding. Record review failed to evidence the potential interactions between aspirin and nebivolol; omeprazole and ferrous sulfate; and aspirin and diclofenac. During an interview on 8/10/2023, at 4:16 PM, the Clinical Manager indicated the PT should have checked on the comprehensive assessment that medication interactions were identified and indicated the document was inaccurate. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by the Alternate Clinical Manager/registered nurse (RN) and dated 7/27/2023, which indicated the patient’s medications included, but were not limited to, doxycycline (antibiotic) and amoxicillin-potassium clavulanate (antibiotic). Review indicated the RN checked no issues were identified during the medication review. Review of medication interactions on Medscape.com on 8/10/2023, indicated a serious medication interaction between doxycycline and amoxicillin-potassium clavulanate which can cause a decreased therapeutic effect of the amoxicillin. Record review failed to evidence the potential serious interaction between doxycycline and amoxicillin-potassium clavulanate. During an interview on 8/10/2023, at 4:25 PM, the Clinical Manager indicated there were no medication interactions noted for the patient.

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 home health agency failed to ensure the organization and management of the home health agency as follows: the governing body failed to assume full legal authority and responsibility for the agency’s overall management and operation (see tag G0942); the administrator failed to report to the governing body (see tag G0946); the governing body failed to authorize in writing the a pre-designated person in the administrator’s absence (see tag G0954); failed to ensure the clinical manager provided oversight of the patient assignments (see tag G0960); and failed to ensure all services provided under arrangement provided by other entities had a written agreement (see tag G0978). The cumulative effect of these systemic problems has resulted in the home health agency's inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFR 484.105 Organization and Administration of Services. A deficient practice citation was also evidenced at this standard as follows: Based on record review and interview, the agency failed to ensure the organizational structure was set forth in writing to include the lines of authority and services furnished and failed to ensure all services not furnished directly were monitored and controlled. The findings include: 1. Review of an untitled agency document dated 4/3/2023, and identified as the organizational chart, indicated field staff provided care to the patients and failed to evidence the types of services furnished to the patients and lines of authority for the field staff. During an interview at the entrance conference on 8/9/2023, at 10:06 AM, the Administrator indicated the agency provided skilled nursing services from registered nurses and licensed practical nurses; therapy services from physical therapists, physical therapy assistants, occupational therapists, occupational therapy assistants, and speech therapists; and social work services. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by the Alternate Clinical Manager/registered nurse (RN) and dated 7/27/2023, which indicated Corporate Staff 3 made edits to the note in collaboration with the Alternate Clinical Manager. During an interview on 8/10/2023, at 3:39 PM, the Administrator indicated Corporate Staff 3 had access to the agency’s plans of care and did quality review for the agency. The Administrator indicated Corporate Staff 3 was not a direct or contracted employee of the agency and was an employee of Entity A. Review of an agency document dated 7/20/2023, titled “Quality Assessment [and Performance Improvement (QAPI) Meeting Agenda and Governing Body Report” indicated Corporate Staff 2 was included in the QAPI meeting. During an interview on 8/11/2023, at 3:38 PM, the Administrator indicated Corporate Staff 2 was not a direct or contracted employee but was an employee of Entity A. The Administrator indicated Corporate Staff 2 assisted in QAPI by gathering and reviewing data. Review failed to evidence the agency defined the roles and responsibilities of Entity A to include how the services provided by Entity A would be monitored and controlled. During an interview at the entrance conference on 8/9/2023, at 10:06 AM, the Administrator indicated the agency did not have a contract with Entity A and indicated the agency was owned by Entity A. The Administrator indicated Entity A was involved in the quality assessment performance improvement (QAPI) program, policy development, and quality review of the clinical records and plans of care. During an interview on 8/9/2023, at 2:20 PM, Corporate Staff 1 indicated there was not a contract or agreement between Entity A and the agency. Corporate Staff 1 indicated the agency was under the umbrella of Entity A and was subject to the corporation’s policies and procedures and not agency specific policies as per the purchase agreement.

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 observation, record review and interview, the governing body failed to assume full legal authority and responsibility for the agency’s overall management and operation and failed to ensure the accuracy of public information per agency policy. The findings include: 1. Review of an undated agency policy on 8/11/2023, titled “Governing Body” stated, “… The Governing Body prepares to … Direct to prepare and oversee an overall budget that includes an annual operating budget … The Governing Body ensures that the Agency … Disperses accurate information in publications and advertisements available to the public….” 2. During an interview at the entrance coferenced on 8/9/2023, at 10:06 AM, the Administrator indicated the agency was not a part of corporate and became independent in July 2022. Review on 8/9/2023 of an agency document titled “First Amendment to Amended and Restated Limited Liability Company Agreement of [Entity E]” dated 10/1/2021, and identified as the agency’s bylaws, indicated the document was signed solely by Corporate Staff 4 from Entity F. Review of an agency document on 8/9/2023, titled “Governing Body” and dated 2023, failed to list Corporate Staff 4 as a governing body member. During an interview on 8/10/2023, at 9:37 AM, with Administrative Staff 4 (governing body member), Administrative Staff 4 indicated Corporate Staff 4 was on the board of directors for Entity F. 3. During an observation upon entrance to the agency on 8/9/2023, at 9:39 AM, a sign on the building and the lettering on the front door indicated Enhabit Home Health and Hospice. During an entrance conference on 8/9/2023, at 10:06 AM, the Administrator distributed business cards with her contact information that indicated Enhabit Home Health and Hospice. During an interview at the entrance conference on 8/9/2023, at 10:06 AM, the Administrator indicated the agency did not provide hospice services and indicated the signage on the front of the door and on the building and the name on her business card was the company’s logo. The Administrator indicated the agency did not provide home health aide services. Review of the agency admission packet on 8/9/2023, indicated the agency provided home health aide services. A banner in the lobby of the agency was observed on 8/9/2023, at 1:41 PM, which indicated the agency provided home health aide services. Review of a survey document titled “CMS 1572” completed by the Administrator and dated 8/9/2023, failed to evidence the agency provided home health aide services. During an interview on 8/9/2023, at 1:43 PM, the Administrator indicated the sign in the lobby may have come from the corporate office. The Administrator indicated the agency had not provided home health aide services in awhile and did not have any active home health aides employed directly or via contract. 4. During an interview during a review of the agency’s budget for 2023 on 8/9/2023, at 2:20 PM, the Administrator indicated she was unsure how much monthly was budgeted on staffing costs total. The Administrator indicated the budget was generated by the finance department at the corporate office and she was just expected to follow it.

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 administrator failed to report to the governing body. The findings include: Review of an untitled agency document dated 4/3/2023, and identified as the organizational chart, indicated the Administrator reported to Corporate Staff 1. Review of an agency document on 8/9/2023, titled “Governing Body” and dated 2023, failed to list Corporate Staff 1 as a governing body member. During an interview on 8/9/2023, at 2:20 PM, Corporate Staff 1 indicated she was the administrator’s direct supervisor. During an interview on 8/9/2023, at 3:11 PM, the Administrator indicated she reported to Corporate Staff 1 and was unsure per CMS regulations who the administrator was to report to.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the governing body and administrator failed to authorize in writing a pre-designated person in the absence of the administrator. The findings include: Review of an agency document dated 10/20/2022, titled “Delegation of Authority” failed to evidence the governing body authorized the Alternate Administrator to assume the responsibilities of the administrator in the administrator’s absence. During an interview on 8/9/2023, at 1:55 PM, the Administrator indicated there was no other documentation for the appointment of the Alternate Administrator and indicated the Alternate Administrator was authorized by the Administrator.

Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This ELEMENT is not met as evidenced by: Based on record review and interview, the clinical manager failed to provide oversight of patient assignments in 1 of 3 home visits receiving services from a certified occupational therapy assistant (COTA). (Patient # 6) The findings include: Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Home Health Certification and Plan of Care” for certification period 7/27/2023-9/24/2023, which indicated the agency was to provide physical therapy services 2 times a week and occupational therapy services 1 time a week for the week of 8/6/2023. During an interview at the home of Patient #6 on 8/11/2023, at 9:55 AM, Patient #6 indicated he/she did not want 2 therapy visits on the same day as it was too much and made him/her tired. Patient #6 indicated the physical therapist would come today because that was who contacted the patient first. Review of an agency document on 8/9/2023, titled “Worker Schedule Report” indicated Physical Therapist Assistant (PTA) 3 was scheduled for visits with Patient #6 on 8/8/2023 and 8/11/2023, and indicated COTA 1 was scheduled a visit with Patient #6 on 8/10/2023. Clinical record review on 8/11/2023, failed to evidence a occupational visit had been provided to the patient for the week of 8/6/2023. Review failed to evidence a missed visit note or communication regarding why the occupational therapy visit was not provided as scheduled on 8/10/2023. During an interview on 8/11/2023, at 5:56 PM, COTA 1 indicated Patient #6 had 2 doctor appointments on 8/10/2023 so the patient was rescheduled for 8/11/2023. COTA 1 indicated the patient’s caregiver informed COTA 1 that the patient did not want 2 therapy visits in 1 day and already had a scheduled visit with PTA 1. COTA 1 indicated he/she would not be available on 8/12/2023, to conduct the visit and meet the patient’s frequency as ordered and would just submit a missed visit note. COTA 1 indicated he/she had not yet communicated with the physical therapist and the office regarding the patient’s missed visit and had not yet documented the missed visit. During an interview on 8/11/2023, at 6:53 PM, the Clinical Manager indicated she had not been informed by COTA 1 of the change in patient’s schedule, the missed visit and the inability to meet the patient’s ordered frequency.

Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA's patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to have a written agreement with another organization furnishing services under arrangement to the agency’s patients in 1 of 1 agency. The findings include: 4. Clinical record review on 8/10/2023, for Patient #1, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by the Alternate Clinical Manager/ RN and dated 7/21/2023, which indicated Corporate Staff 3 made edits to the note in collaboration with the Alternate Clinical Manager. 5. Clinical record review on 8/11/2023, for Patient #3, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by the Alternate Clinical Manager/ RN and dated 7/11/2023, which indicated Corporate Staff 3 made edits to the note in collaboration with the Alternate Clinical Manager. 1. Clinical record review on 8/10/2023, for Patient #5, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by Physical Therapist (PT) 1 and dated 8/3/2023, which indicated Corporate Staff 3 made edits to the note in collaboration with the PT. 2. Clinical record review on 8/10/2023, for Patient #6, evidenced an agency document titled “Skilled Note Report” identified as the start of care comprehensive assessment completed by the Alternate Clinical Manager/registered nurse (RN) and dated 7/27/2023, which indicated Corporate Staff 3 made edits to the note in collaboration with the Alternate Clinical Manager. 3. During an interview on 8/10/2023, at 3:39 PM, the Administrator indicated Corporate Staff 3 had access to the agency’s plans of care and did quality review for the agency. The Administrator indicated Corporate Staff 3 was not a direct or contracted employee of the agency and was an employee of Entity A.

An Emergency Preparedness survey was conducted by the Indiana State Department of Health in accordance with 42 CFR 484.102. Facility ID: 004608 Visit dates: 1/13/2021, 1/14/2021, 1/15/2021, 1/19/2021 At this Emergency Preparedness survey, Encompass Health - Home Health was found to not be in compliance with 42 CFR 484.102, Emergency Preparedness Requirements for Medicare Participating Providers and Suppliers.

Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years (annually for LTC).] At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency failed to ensure the use of volunteers to address surge needs during an emergency. The findings include: 1. An agency policy number E06, titled "Emergency preparedness plan" revised on 6/10/2020, stated "1.0 Purpose ... 1.1 To provide employees with established guidelines to respond to disaster situations ... 1.3 To minimize hazards and unsafe situations related to disasters ... 2.0 Definitions ... 2.2 Disasters may include, but are not limited to fires, tornados, winter storms, flooding, bomb threats, civil disturbances, and communicable illnesses affecting a majority of the staff ... 3.0 Policy ... 3.1 The Agency will involve the Administrator, Supervising Nurse/BD [branch director](s) ... and other individuals the Administrator deems appropriate in the development, maintenance and implementation of the emergency preparedness and Response Plan ... 3.4 The plan will be based on a risk assessment that identifies potential disasters from either natural or man-made causes that are most likely to occur in the Agency service area ... 3.7 ... Any hospice volunteer helping during a disaster will be issued a temporary name badge in order to be identified. Other volunteers will not be utilized during an emergency. Staff from other Encompass offices will be used to supplement staffing in an affected branch, both with visits and workflow ... " 2. During an interview on 1/13/2021, at 2:45 PM, employee A, administrator/branch director, indicated in the event of emergency staffing needs, they would utilize a volunteer fire department for certain areas to help evacuate patients, as needed. Employee A was then queried if staff and volunteers have documented emergency preparedness training, to which they indicated they do not have volunteers. The agency policy confirmed the agency does not utilize volunteers as the federal emergency preparedness regulations require.

This survey was a recertification, re-licensure, federal focused infection control, emergency preparedness of a home health agency. Survey Dates: 1/13/2021, 1/14/2021, 1/15/2021, 1/19/2021 Facility ID: 004608 Skilled Unduplicated Census: 331 These deficiencies reflect State Findings cited in accordance with 410 IAC 17. Refer to state form for additional state findings.

Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This ELEMENT is not met as evidenced by: Based on record review, the home health agency failed to ensure the patient received proper written notice of non-covered services in 1 of 2 discharged patients, in a total sample of 9 clinical records reviewed. (#9) The findings include: 1. An agency policy, number S03, titled "Patient Rights" revised on 6/30/2020, stated "1.0 Purpose ... 1.1 Inform the patient of his/her rights as a patient of the agency during the initial evaluation visit, in advance of furnishing care to the patient ... 1.2 Confirm that the agency promotes and protects the patient's rights ... 2.0 Definitions ... 2.1 Statements of rights are written documents prepared by the agency which identify the patients rights to: ... 2.1.6 Participate in planning the care and treatment and any changes ... 2.1.8 Be informed of the extent to which payment may be expected from Medicare, Medicaid or any other federally funded or aided program known to the agency ... 2.1.12 The agency: 2.1.12.1 Advises the patient of charges that will not be covered by Medicare and the charges for which the patient may be liable ... 2.1.12.2 Provides this information orally and in writing before the care is initiated and as soon as possible but no later then five calendar days from the date that the agency becomes aware of the change ... 2.2 For home health the service agreement is a written statement which identifies ... 2.2.3 The charge is for services that will not be covered by Medicare ... 3.0 Policy ... 3.3 During the process of care delivery... 3.3.3 the Case Manager/nursing personnel informs the patient ... 3.3.3.2 In home health in writing of any changes in the charges, extent of Medicare coverage, or patient liability as soon in advanced or on the next visit ... " 2. Clinical record review on 1/19/2021, for patient #9, start of care 11/7/19, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 7/4/2020 - 9/1/2020. This document had an area subtitled "Frequency/Duration of Visits" that stated "PT [physical therapy] effective 07/05/2020 2WK4 [two times a week for four weeks], 1WK4 [one time a week for four weeks] ... " Another area stated "Orders for Discipline and Treatments: PT to eval [evaluate]/assess for body structure and function impairments, activity limitations, and rehab potential ... PT will provide ongoing monitoring for changes in health status, treatment regimens ... PT will develop Plan of Care in coordination with the interdisciplinary care team, physician, and patient ... " Record review evidenced an agency document titled "Notice of Medicare Non-Coverage" which was signed by patient #9. This document stated "The Effective Date Coverage Of Your Current PT [and] Skilled Nursing Services Will End: ... 2/11/2020 with a line drawn through it]." Above that date was written "5/5/20 [with a line drawn through it]." Above that date was written "9/1/20". Below the effective end date, the document also stated "Your Medicare provider and/or health plan have determined that Medicare probably will not pay for your current SN [skilled nursing]/ PT services after the effective date indicated above ... You may have to pay for any services you receive after the above date ... " On the bottom of page 2 of this notice stated "I have been notified that coverage of my services will end on the effective date indicated on this notice and that I may appeal this decision by contacting my QIO [Quality Improvement Organization]" followed by the patient's signature dated 1/28/2020 [with a line drawn through it]." Above that date was written "5/5/20 [with a line drawn through it]." Below the original that was written "7/4/20" Record review failed to evidence the patient was receiving skilled nursing services for the certification period reviewed, but was indicated on the "Notice of Medicare Non-Coverage" form. Record review failed to evidence the patient was notified of non-covered services being furnished in advance for each certification period. When queried why the "Notice of Medicare Non-Coverage" was filled out in that way (crossing out dates, and writing in new dates), employee A, administrator/clinical manager, and employee B, alternate administrator/ alternate clinical manager, remained silent.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician. This ELEMENT is not met as evidenced by: Based on record review, the agency failed to ensure all drugs, services, and treatments were administered only as ordered by the physician for 1 of 7 active clinical records reviewed, from a total sample of 9 clinical records reviewed. (#8) The findings include: 1. Clinical record review on 1/19/2021, for patient #8, start of care 1/2/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 1/2/2021 - 3/2/2021. The document had an area subtitled "Frequency/Duration of Visits" that stated "SN [skilled nurse] 1WK4 [one visit per week, for 4 weeks] ... PT [physical therapy] 1WK1 [once a week for one week] 2WK2 [twice a week for two weeks] 1WK5 [once a week for five weeks] ... OT [occupational therapy] effective 1/3/2021 1WK1 [once a week for one week] ... " Another area subtitled "Orders for Discipline and Treatments" stated "Skilled nurse to perform a comprehensive assessment and evaluate the needs for home health services ... Occupational therapist to evaluate for OT services ... PT to eval [evaluate]/assess for body structure and function impairments, activity limitations, and rehab potential related to current health conditions ... " Record review failed to evidence a physician order for Encompass Home Health to provide skilled nursing, physical therapy, and occupational therapy services. During record review, a physician's order for services was requested from employee A, administrator/clinical manager, and employee B, alternate clinical manager. Employee B pointed to the fax cover sheet and indicated it was addressed to Encompass Health. They were informed a fax cover sheet addressed to the agency would not be considered a physician order for home health services. 410 IAC 17-13-1(a)

Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the HHA as frequently as the patient's condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the plan of care was revised as the patient's needs required for 2 of 4 patients who received a home visit. (#3, #6) The findings include: 1. An agency policy number S10, titled "Patient reassessment [and] recertification" reviewed 11/11/2020, stated "1.0 Purpose ... Establish guidelines for timely reevaluation of the patient's needs and care delivery ... 2.0 Definitions ... 2.3 Appropriate licensed professional for reassessments is defined as a RN [registered nurse], PT [physical therapist], ST [speech therapist], or OT ... 3.0 Policy ... 3.1 The registered nurse and other licensed professional staff as appropriate, ... 3.1.2 Review the patient's plan of care ... 3.1.2.1 As often as the severity of the patient's condition requires ... 3.5 Following established procedures, staff document ... 3.5.3 Revision and recertification of the plan.... " 2. An agency policy number S07, titled "Medications" revised 5/28/2020, stated "1.0 Purpose ... 1.1 Establish guidelines for the appropriate administration and management of medications for patients and establish guidelines for appropriate personnel to administer medications ... 1.2 To facilitate timely, accurate and complete documentation and provide timely interventions for patients involved in medication errors ... 1.3 To implement a quality and risk management monitoring system for medication errors ... 3.0 Policy ... 3.1.3 The case manager consolidates all pertinent orders for medications into the plan of care at the time the medication is prescribed, or for over the counter medications at the time that they are found in the home ... " 3. Clinical record review on 1/19/2021, for patient #3, start of care 1/8/2021, evidenced an agency document titled "Home Health Certification and Plan of Care" for certification period 1/8/2021 - 3/8/2021. This document had an area subtitled "Medications" that stated "Acetaminophen [mild pain reliever] 325 MG Tablet ... 2 Times Daily ... Ativan [sedative] 1 MG Tablet ... 2 [times per] day as needed for anxiety ... Lorazepam [sedative, generic for Ativan] 1 MG Tablet ... 2 Times Daily ... " This document was requested on 1/13/2021 prior to the patients home visit and was failed to be signed by the physician. Record review evidenced a document from entity E, assisted living facility [ALF], titled "Physician's Orders" for the time frame of 1/1/2021 - 1/31/2021. This document had a section subtitled "Medications" that stated "Acetaminophen Tab [tablet] 325 MG ... 2 Tablets (650MG) By Mouth Two Times A Day ... Lorazepam Tab 1MG ... 1 Tablet By Mouth Two Times A day For Anxiety ... Acetaminophen Tab 325MG ... 2 Tablets (650MG) By Mouth Every Four Hours As Needed For Pain Or Temp [temperature/fever] ... " This document was signed by the Nurse Practitioner (NP), for entity E on 1/5/2021. This document was requested from Entity E on 1/14/2021, during a home visit conducted at 10:30 AM. Record review failed to evidence the medication list on the agency's "Home Health Certification and Plan of Care" matched the medication list from entity E, where the patient resides. Record review failed to evidence the Plan of Care was revised to reflect the changes in the patient's medication needs. 4. Clinical record review on 1/19/2021, for patient #6, start of care 12/24/2020, evidenced an agency document titled "Home Health Certification and Plan of Care" for the certification period 12/24/2020 - 2/21/2021. This document had an area subtitled "Medications" that listed 7 medications, which included Acetaminophen, Carvedilol [used to treat high blood pressure], Divalproex [used to treat bi-polar disorder], Donepezil [used to treat Alzheimer's disease], escitalopram, ezetimibe [used to treat high cholesterol] , and hydrocodone/acetaminophen [opioid pain medication]. This document was requested on 1/13/2021 prior to the patient's home visit and was failed to be signed by the physician. Record review evidenced a document from entity E titled "Physician's Orders" for the time frame of 1/1/2021 - 1/31/2021. This document had a section subtitled "Medications" that listed 8 medications which included Carvedilol, Divalproex, Donepezil, Escitalopram, Ezetimbe, Acetaminophen, Loperamide [anti-diarrheal], and Norco [brand name for hydrocodone/acetaminophen]. This document was signed by the Nurse Practitioner (NP), for entity E on 12/30/2020. This document was requested from Entity E on 1/14/2021 during a home visit conducted at 10:30 AM. Record review failed to evidence the medication list on the agency's "Home Health Certification and Plan of Care" matched the medication list from entity E, where the patient resides. Record review failed to evidence the Plan of Care was revised to reflect the changes in the patient's medication needs. During an interview on 1/19/2021, at 5:53 PM, employee A, administrator, indicated medications are reviewed for therapy only cases at every visit. The clinician will ask the patient or the facility nurse. The administrator indicated therapy was made aware of changes in the plan of care via case conference, conversation, or by looking at the patient orders. Employee A added the home health agency would start to have therapy only cases medications reviewed at each visit. During an interview on 1/19/2021, at 6:42 PM, employee A indicated the Plan of Care was revised with a new order. When queried if the Plan of Care was revised to show the most updated physician orders, they expressed the medication list was updated and sent to the physician and the patient. The new medication list was printed and updated in the patients home. 410 IAC 17-13-1(a)(2)

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on record review and interview, the agency failed to ensure the physician was promptly notified that patient outcomes were not being achieved and treatment according to the plan of care should have been altered in 1 of 2 discharge records reviewed, in a total sample of 9 records reviewed. (#2) The findings include: 1. An agency policy number S01, titled "Scope of services" revised on 4/23/2020, stated "1.0 Purpose ... 1.2 Define the scope of services the Agency offers. 1.3 Describe the responsibilities of the services ... 3.0 Policy ... 3.1 The Agency establishes and controls the scope of services it provides ... The supervising physician and/or registered nurse supervises and directs skilled nursing and therapeutic services ... 3.4 The Agency provides skilled nursing services by or under the supervision of a registered nurse and in accordance with the plan of care and established policies and procedures. The registered nurse ... 3.4.2 Regularly reevaluates the patient's nursing needs. 3.4.3 Initiates the plan of care and necessary revisions ... 3.4.5 Initiates appropriate preventative and rehabilitative skilled nursing procedures ... 3.4.7 Coordinates services ... Informs the physician and other personnel of changes in the patient's condition and needs ... 3.4.14 Follows the nursing process in identifying nursing-prescribed actions such as assessment and teaching ... " 2. An agency policy number S22, titled "Wound ulcer management with Wound etiologies" reviewed on 10/28/2020, stated "1.0 Purpose ... 1.3 To establish acceptable standards of practice as it relates to the appropriate management of a wound/ulcer that promotes and maximizes wound/ulcer-healing process ... 3.0 Policy ... 3.3 Subsequent Assessments / Evaluations: ... 3.3.2 The appropriately licensed professional shall evaluate the patient's response to the current treatment modalities, whether the current treatment modalities require modifications, and any events or conditions that are impeding the normal wound/ulcer healing process and notify the physician. 3.3.3 Wound/Ulcer Measurements and Staging: ... 3.3.3.6 All wounds are numbered and measured individually ... Wound measurements are reported in centimeters. Disposable rulers are used to obtain measurements. Length is derived by measuring the greatest distance of the wound oriented from the patient's head to the patient's toe. Width of the wound is measured perpendicular to the length. It is the greatest side-to-side distance, which is oriented from the patients arm-to-arm. The greatest depth should be measured from the deepest part of the wound ... Depth should not be reported as a '0' if there is necrotic [dead] material or if there is an open wound, as this would calculate the total surface area of any wound (L [length] x W [width] x D [depth]) to be '0' ... To measure depth, place sterile probe into the deepest part of the wound bed. Grasp the probe by the wound margin and place it against the ruler to obtain that measurement ... " 3. Clinical record review on 1/19/2021, for patient #2, start of care 2/21/2020, evidenced a document titled "Home Health Certification and Plan of Care" for certification period 8/19/2020 - 10/17/2020. This document was signed by the patient's physician and stated "Patient's Expressed Goals: ... For wound to decrease in size ... Diagnoses: ... Unspecified Open Wound of Right Breast ... Other Specified Type of Carcinoma [type of cancer] in situ [contained in its original place or position] of Right Breast ... " There was an area subtitled "Orders of Discipline and Treatments:" that stated "Skilled nurse to observe and assess skin integrity and hygiene ... Skilled nurse to perform/teach ALF [Assisted living facility] staf [sic] wound care to right breast remove old dressing, cleanse with normal saline, pat fry [sic] apply Bactroban [medication] to woundc [sic]cover with xeroform [gauze soaked in petroleum jelly] or equivalent, apply folded 4x4's [gauze that measures 4 inches on each side] under breast and instructed [skilled nurse] to reform [sic] wound care during nursing visit. ALF to perform wound care on non nursing days. May discontinue wound care when wound is healed ... " Another area subtitled "Goals/Rehabilitation Potential/Discharge Plans:" stated "Patient will be free of exacerbation of skin integrity problems during this episode of care ... Wound status will improve as evidenced by a decrease in size, drainage, absence of infection, and decreased pain.... " Record review evidenced documents titled "Visit Note Report" which had an area designated for a comprehensive assessment subtitled "Wound Assessment" and had section to document the measurements of the wound located on the patient's right breast. The measurements [in L x W x D] for the following dates are as follows: 8/25/2020 - 10.5 cm x 16 cm x 0 cm; 9/1/2020 - 10 cm x 16.5 cm x 3 cm; 9/8/2020 - 10 cm x 15 cm x 3 cm; 9/15/2020 - 10 cm x 15 cm x 0 cm, bloody drainage, 9/23/2020 - 10.5 cm x 15 cm x 2.5 cm, bloody drainage. Record review evidenced a document titled "Visit Note Report" dated 10/15/2020, that had an area subtitled "Narrative" and stated "Patient was transferred to [Entity F, hospital] 10/1 [2020] due to uncontrolled bleeding to right breast cancer lesion ... " signed by person G, registered nurse [RN]. Record review failed to evidence the patient's physician was promptly alerted to the worsening of the wound and patient outcomes were not being achieved. Record review failed to evidence the RN alerted the physician for a change in the wound care treatment orders. Record review failed to evidence the physician was notified the plan of care should be altered. During an interview on 1/19/2021, at 6:35 PM, employee B, alternate clinical manager, indicated the fluctuation in depth measurements could be from how the patient was laying and or the position they were in. When queried if the RN should have notified the doctor about the worsening wound, the need for a change in treatment, or to alter the plan of care employee B stated "I can't speak for the nurse." 410 IAC 17-13-1(a)(2)

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation and record review, the home health agency failed to ensure all employees followed standard precautions to prevent the transmission of infections and communicable diseases in 1 of 4 home visits conducted. (employee E) The findings include: 1. An agency policy number I01, titled "Standard Precautions" reviewed 9/11/2020, stated "1.0 Purpose ... 1.1 To reduce potential cross contamination that may occur through staff/patient contact with provider care and to safeguard the health of the care giver and patient. 1.2 To provide a consistent and uniform approach for health care staff in the prevention of transmission of infection while working with any home care or hospice patients ... 2.0 Definitions ... 2.1 Standard precautions are an approach to infection control. According to the concept of standard precautions, all human body fluids are treated as if known to be infectious for HIV , HBV , and other blood borne pathogens ... 3.0 Policy ... 3.1 It is the policy that the Agency's employees and contracted staff will follow the CDC [Central for Disease Control] Guidelines and OSHA [Occupational Safety and Health Administration] Standards regarding standard precautions. 3.2 All health care workers will routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with blood or other body fluids, mucous membranes, or non-intact skin for all patients, for handling items or surfaces soiled with blood or body fluids, and for performing venipuncture and other access procedures. Gloves are changed after contact with the patient ... " 2. An agency policy number I02, titled "Hand Hygiene" reviewed on 9/11/2020, stated "1.0 Purpose ... 1.1 To remove dirt and transient pathogenic flora aiding in the prevention and the spread of infection ... 2.0 Definitions ... 2.1 Hand hygiene is considered the single most important procedure in the prevention of transmission of infection ... 3.0 Policy ... 3.1 It is the policy of the Agency that all field and office personnel will adhere to the Hand Hygiene procedure ... 4.0 Procedure ... 4.1 Alcohol based hand rubs [ABHR] are the most efficacious agents for reducing the number of bacteria on the hands, and will be used for routine decontamination of the hands for all clinical indications (except when hands are visibly soiled) as recommendation by the Center for Disease Control ... 4.2 Hand washing with soap and water will be used for hand hygiene when hands are visibly soiled ... 4.3.[sic] At a minimum, personnel will perform hand hygiene in the following instances: 4.3.1 Upon entry into the patient's home, before any patient contact ... 4.3.6 After any contact with patient excretion (feces, urine) or secretions (from wounds, nasopharynx, trachea, skin infections, etc.) or with articles/surfaces contaminated by secretions or excretions ... " 3. An agency policy number I03, titled "Bag/equipment technique" reviewed on 9/11/2020, stated "1.0 Purpose ... 1.1 To reduce potential cross contamination that may occur through staff/patient contact while providing care ... 3.0 Policy ... 3.1 It is the policy of the Agency that all field staff will adhere to the bag/equipment technique procedure ... 4.0 Procedure ... 4.1 The clinical bag and related equipment will be used in accordance with the following directions: ... 4.1.10 Use paper towels or other barrier such as plastic, underpad, etc., as protective shields while in the performance of various patient care functions ... 4.1.12 After care is given, clean all equipment ... thoroughly with alcohol ... 4.1.13 Clean hands again using proper technique, and return items to bag ... " 4. During observation of a home visit which was conducted on 1/14/2021, at 2:33 PM, in the residence of patient #1, at entity E, an assisted living facility. Employee E, physical therapy assistant (PTA) was observed to have first placed their work bag on the counter next to the sink, without placing a barrier between the bag and the surface of the counter. The PTA proceeded to wash hands with soap and water, and dried with paper towels. At 2:38 PM, employee E donned new gloves and assessed the patients blood pressure on the right arm (108/72), temperature (97.7 Fahrenheit), and pulse (87 beats per minute). At 2:52 PM, employee E demonstrated, instructed, and assisted leg exercises including knee raises, toe taps, and heel raises, while the patient sat in the wheel chair. At 3:01 PM, employee E instructed and assisted the patient to stand with a walker from sitting, and back to the sitting position in the wheel chair, three times. At 3:06 PM, employee E began to document on their agency tablet that was not on or returned to a barrier. Next, employee E assisted the patient in using ABHR and cleaned a therapy ball with a disinfectant wipe. At 3:11 PM, the employee and the patient bounced the ball back and forth until the patient became tired. Employee E assisted the patient to use ABHR and cleaned the ball with a disinfectant wipe. With new wipes, employee E cleaned their stethoscope and blood pressure cuff and placed the items back in the employee's bag. Employee E finished documenting and then disinfected the tablet with another wipe. At 3:21 PM, employee E removed their gloves. The employee washed their hands with soap and water, dried with paper towels, discarded in a trash bin, and concluded the visit without wiping the bottom of the bag. The employee failed to use a barrier underneath their work bag to prevent cross contamination between patients. The employee failed to change gloves at the appropriate times during the home visit, such as after patient contact and after coming in contact with contaminated items/surfaces. The employee failed to remove soiled gloves and perform hand hygiene prior to cleaning reusable equipment, such as the blood pressure cuff and stethoscope, and prior to placing reusable equipment in the employee's work bag. On 1/15/2021, at 4:02 PM, employee A, administrator, was notified of the concerns, which he/she wrote down, then pointed to their notes and stated "I do not like this." 410 IAC 17-12-2(g)