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“Basis and Scope CFR(s): §484.1 Basis and Scope (a) Basis. This part is based on: (1) Sections 1861(o) and 1891 of the Act, which establish the conditions that an HHA must meet in order to participate in the Medicare program and which, along with the additional requirements set forth in this part, are considered necessary to ensure the health and safety of patients; and (2) Section 1861(z) of the Act, which specifies the institutional planning standards that HHAs must meet. (b) Scope. The provisions of this part serve as the basis for survey activities for the purpose of determining whether an agency meets the requirements for participation in the Medicare program. This Condition is not met as evidenced by: Based on a review of facility documentation, and interviews with staff (EMP) it was determined that the Home Health Agency was not in compliance with the Medicare participatory requirements as defined in the Social Security Act Section §1861, by failing to be primarily engaged in providing skilled nursing services and other therapeutic services. The finding includes: The Social Security Act, Section §1861(o)(1) defines a Home Health agency “is primarily engaged in providing skilled nursing services and other therapeutic services; (2) has policies, established by a group of professional personnel (associated with the agency or organization), including one or more physicians and one or more registered professional nurses, to govern the services (referred to in paragraph (1)) which it provides, and provides for supervision of such services by a physician or registered professional nurse; (3) maintains clinical records on all patients; (4) in the case of an agency or organization in any State in which State or applicable local law provides for the licensing of agencies or organizations of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing agencies or organizations of this nature, as meeting the standards established for such licensing; (5) has in effect an overall plan and budget that meets the requirements of subsection (z); (6) meets the conditions of participation specified in section 1891(a) and such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such agency or organization….” The Connecticut Hospice is currently participating in the Medicare program as a Home Health Agency (HHA). To maintain certification as an HHA, the HHA is required to be primarily engaged in providing “skilled nursing services and other therapeutic services…” Review of facility document, titled “Daily Census Summary,” on April 14, 2025, identified the agency only provided skilled nursing services to two patients in the past 12 months: Patient 1 was admitted on April 10, 2025, and Patient 2, received services from October 11, 2024, through October 29, 2024. Interview on April 15, 2025, at 2:20 PM, with EMP #1 and EMP #2, indicated there had been a significant decline in HHA referrals and active patient caseloads for the last few years. They further indicated only three patients had been admitted for HHA services from March 6, 2023, through October 11, 2024. In addition, they indicated the required HHA patient clinical chart reviews were combined with the Hospice agency records, due to a low census, and the HHA failed to perform essential Quality Assurance Performance Improvement functions. The agency was not primarily engaged as a provider of HHA services, in accordance with their Medicare Certification Classification, and failed to notify the Centers for Medicare and Medicaid Services (CMS) accordingly of changes impacting their Medicare enrollment.”

“Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA’s governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA’s performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This Condition is not met as evidenced by: Based on review of agency documentation and interview with staff (EMP), the agency failed to develop, implement, evaluate and maintain an ongoing home health agency specific data driven quality assessment and performance improvement (QAPI) program. Refer to G0660”

“Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA’s governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This Standard is not met as evidenced by: Based on review of agency documentation and interview with agency staff (EMP), the governing body failed to ensure an ongoing home health agency QAPI program that included adequate data collection for representation of the agency services, organizational structure and functions, for agency quality improvement as it relates to quality of care and patient safety. The finding includes: Review of the agency clinical record review documentation for the last two quarters of year 2022, and for years 2023 and 2024 identified a combined random sampling of home health and hospice patients was conducted quarterly prior to January 2025. Interview with EMP #1 and EMP #2 on April 15, 2025 at 2:20 PM, identified that prior to January 2025, all clinical record review records and data was collected from both the home health and hospice agencies for years 2023 and 2024, as a result of a significant decline in the home health patient census. EMP #1 and EMP # 2 further identified the agency only had three (#3) home health patients admitted between March 6, 2023 and October 11, 2024, and failed to identify the governing body ensured an adequate patient census for the collection and review of statistical data, and failed to identify the development of a quality improvement program that identified any adverse outcomes for the implementation of improvements for any identified indicators, and failed to identify the maintenance of a program for surveillance, identification, prevention, control and investigation of infectious and communicable diseases specific to the home health agency.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on medical record review, documentation review, policy review and interview with staff (EMP), the agency failed to ensure the plan of care addressed the patient’s needs. The finding includes: Patient #2 had a start of care date of October 11, 2024 and diagnoses that included obstructive and reflux uropathy, gastrointestinal hemorrhage and acute on chronic congestive heart failure. The physician’s orders dated October 11, 2024 included nursing services two to three times a week for assessments, management of an indwelling urinary catheter with catheter changes every three weeks and a social work evaluation. Patient #2 resided in an Assisted Living Facility/ALF. Review of the physician’s orders and initial nursing assessment identified an initial admission weight measurement of 180 pounds for Patient #2. Interview and review of the physician’s orders and initial nursing assessment with EMP #2 on April 15, 2025 at 1:20 PM identified an initial admission weight measurement of 180 pounds, but failed to identify documentation of communication with the physician for the need of daily weight monitoring and weight parameters for the reporting of abnormal results for health maintenance of the patient per the agency policy. Review of the agency policy for Nursing Management of Heart Failure patients directed if able, patient/family should weigh patient daily to monitor for fluid retention, a weight gain of 2-3 pounds a day or 5 pounds in a week is often a sign of fluid retention and may prompt an increase in diuretic therapy.”

“Participate in the HHA’s QAPI program; CFR(s): 484.75(b)(8) Participation in the HHA’s QAPI program; and This Element is not met as evidenced by: Based on interviews with agency staff (EMP), review of agency policies and review of the agency’s quarterly clinical record documentation, the agency failed to complete quarterly record reviews with agency health professionals’ input and participation. The finding includes: Review of the agency’s quarterly clinical record reviews for the third and fourth quarters of years 2022, and all quarters of years 2023 and 2024, failed to identify evidence that nursing and physical therapy staff members participated in the review of at least eight, active and closed clinical records during the quarterly review. Interview with EMP #1 and EMP # 2 on April 15, 2025 at 2:20 PM, identified that the quarterly clinical record reviews, prior to January 2025, were a random sampling of homecare and hospice patients combined, and failed to identify home care agency nursing and physical therapists’ participation in the quarterly record reviews representing the agency’s home care services provided. Review of the agency policy for Clinical Record Review directed qualified individuals will review a representative sample of medical records in order to ensure that the documentation is complete, accurate and timely. Clinical supervisors or their designee(s) and/or the Director of Quality or their designee(s) will complete the review. #1. Occurs quarterly. #2. Home hospice records consist of 10% of the average daily census in a random sample representing the practitioners providing care. #3. Inpatient hospice records consist of 10 records in a random sample representing the practitioners providing care. #4. Home health records consist of all patients admitted on to home health services representing the practitioners providing care.”