Angel’s Hope Home Health, Inc.

“Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This Standard is not met as evidenced by: Based on policy review, Quality Assurance Performance Improvement (QAPI) document review, and interview, the Home Health Agency (HHA) failed to develop and implement a QAPI program that included quality indicators for high risk and high volume indicators. The HHA failure to include high risk and volume quality indicators had the potential to affect the188 patients receiving services from the HHA. Findings include: Review of the Agency’s undated policy titled, “Quality Assessment and Performance Improvement (QAPI) Plan and Program,” revealed, “…directed staff to collect data including care that is high-risk, high volume and problem prone areas …collection of data regarding the point of care laboratory testing as allowed by Certified Laboratory Improvement Assessments (CLIA) waiver.…” Review of the QAPI data collected by the agency did not include indicators for the high-risk care the agency provided that included frequent intravenous medication administration, the high volume of wound care and problem prone areas including patient falls. During an interview on 02/05/25 at 3:30 PM, the Executive Director/Director of Nursing acknowledged the agency had a change in staffing and were in the process of reimplementing their QAPI program. The Executive Director/Director of Nursing confirmed the agency identified the need for data collection in multiple areas of patient care. The Executive Director/Director of Nursing stated the agency had not identified the lack of a current CLIA certificate and had not educated the staff on the new QAPI process.”

“Laboratory services/CLIA waivers CFR(s): 484.100(c)(1) Laboratory services. If the HHA engages in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements of part 493 of this chapter. The HHA may not substitute its equipment for a patient’s equipment when assisting with self-administered tests. This Standard is not met as evidenced by: Based on record review, observation, document review, and interview, the facility failed to maintain a current Clinical Laboratory Improvement Amendments (CLIA) waiver for laboratory testing performed by the Home Health Agency (HHA). The agency’s failure to maintain a current CLIA waiver certificate places patients who require glucose monitoring at risk for inaccurate or inadequate monitoring. Findings include: Review of the CLIA waiver certificate, displayed by the HHA in the entry to the office, revealed the certificate expired on 02/06/25. Review of Patient (P) 9’s Electronic Medical Record (EMR) located under the “Admissions” tab, revealed P9 was admitted to home health services on 01/05/25 with diagnoses that included Type 2 Diabetes Mellitus. Review of the “Physician Orders” revealed an order to conduct finger stick blood glucose monitoring. During a home visit on 02/07/25 at 9:00 AM, Licensed Practical Nurse (LPN) 2, performed a finger stick blood glucose test on P9 using the agency’s blood glucose meter. During an interview on 02/07/25 at 2:00 PM, the Director of Nursing (DON) confirmed the CLIA certificate expired on 02/06/25 and the agency failed to reapply for a CLIA certificate renewal. The DON stated glucose monitoring is the only waived test the agency conducts.”

“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, policy review, and interview, the Home Health Agency (HHA) failed to maintain an up-to-date medication profile for one of four (Patient (P)) 3 reviewed for home visits. The agency’s failure to maintain a current medication list had the potential to affect all 188 patients receiving services by the HHA. Findings include: Review of the agency’s undated policy titled, “Medication Reconciliation,” revealed, “…Procedure 2. The medication list/profile will be updated with each new or changed medication….” Review of P3’s electronic medical record (EMR) under the “Admissions” tab revealed an admission date of 01/05/25 and diagnoses that included diabetes, heart disease and hypertension. Review of the “Physician Orders” dated 01/05/25 located in the EMR under the “Orders” tab revealed the physician ordered Claritin (used to treat allergy symptoms) 10 milligrams (mg) oral daily, Spironolactone (a diuretic) 25mg oral daily and Potassium Chloride Extended Release (a supplement) 20 milliequivalents oral daily. A home visit for P3 was conducted on 02/05/25 at 11:30 AM with the Executive Director/Director of Nursing. Interview with P3 during the visit confirmed he/she was not currently taking Claritin, Spironolactone or Potassium Chloride Extended Release. During an interview on 02/05/25 at 2:30 PM, the Executive Director/Director of Nursing acknowledged P3’s medication list contained medications that he/she was not currently taking and confirmed the agency failed to notify the physician that P3 stopped taking the medications.”