Almost Family

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, record review and interview, the agency staff failed to review emergency medications prior to IV (Intravenous) infusion in 1 of 3 patient home visits (Patient #1) observed. Findings include: Review of agency policy titled “Medication Administration” revised 02/01/2023, revealed under heading, “Procedure: 2.The clinician will check all medications the patient is taking to identify possible ineffective drug therapy or adverse reactions …. and shall report any problems to the physician.” Review of Patient #1’s medical record revealed start of care on 09/20/2019 with primary diagnosis of Ulcerative Colitis. POC (Plan of Care) orders revealed “SN (Skilled Nurse) to initiate peripheral IV access and administering of IV infusion Entyvio every 6 weeks.” Patient #1’s current medication list revealed “Epinephrine (Anaphylaxis) Injection Solution 1mg (milligram)/ml (milliliter) PRN (as needed) for Anaphylaxis reaction to IV medication Entyvio effective 09/20/2019”. During home visit on 12/03/2024 from 4:27PM to 5:30PM the following was observed: At 4:45 PM RN (Registered Nurse) C was observed initiating IV infusion for Patient #1. At 5:10 PM, during IV infusion, RN C was observed completing document titled “ENTYVIO (Vedolizumab) Infusion Nurse Report, Pre-infusion Assessment”. At 5:15 PM, RN C was observed disconnecting Patient #1 from IV infusion. RN C was then observed instructing Patient #1 to retrieve “emergency kit”. Patient #1 provided emergency kit to RN C who then opened sealed plastic bag with label “Rochester IV Infusion” and reviewed 2 ampules labeled “Epinephrine Injection, USP 1mg/ml” with expiration date of “08/2024”. RN C failed to review Patient #1 “emergency kit” medication prior to IV infusion. During interview with Executive Director A on 12/04/2024 at 11:30 AM, findings were confirmed.”

“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 staff failed to follow physician plan of care orders in 1 of 7 patients records reviewed (Patient #6). Findings include: Review of agency policy titled “Plan of Care (POC)” dated 09/01/2024 revealed “Procedure: 7. Medications, treatments, and interventions are provided by qualified agency staff as ordered by the physician or authorized practitioner.” Record review of Patient #6’s “Home Health Certification and POC” with start of care 12/21/2022 and certification dates 04/14/2024 to 06/12/2024 revealed primary diagnosis of Varicose Veins of Right Lower Extremity and secondary diagnosis of Type 2 Diabetes Mellitus with Unspecified Complications. POC orders revealed “Skilled Nurse (SN) Diabetic Care: SN to assess/observe diabetic status. Report to Medical Doctor if blood sugar is above 300 or below 70.” Record review of SN visits for Patient #6 dated 04/14/2024 to 06/11/2024 revealed weekly SN visits were conducted on 04/17/2024, 04/24/2024, 05/01/2024, 05/08/2024, 05/15/2024, 05/22/2024, 05/29/2024, 06/05/2024 with no diabetic status assessed. No blood sugar findings were documented. During an interview with State Clinical Administrator B on 12/04/2024 at 10:30 AM, discussed that there was no documentation of diabetic status for Patient #6 and asked if a blood sugar would be something to assess as part of diabetic status. State Clinical Administrator B agreed and stated, “There is an area to document under diabetes. Is it not there?” During an interview with Registered Nurse (RN) Executive Director A on 12/04/2024 at 11:30 AM, RN Executive Director A stated, “Patient #6 is independent and logs blood sugars and they review them in the home.” There is no documentation in Patient #6’s record to support that the diabetic status was assessed or that Patient #6’s blood sugar logs were reviewed.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on observation, record review and interview, the agency staff failed to notify patient clinic and/or provider of expired emergency medication in 1 of 3 home visits (Patient #1) observed. Findings include: Review of agency policy titled “Medication Administration” revised 02/01/2023, revealed under heading, “Procedure: 2. The clinician will check all medications the patient is taking to identify possible ineffective drug therapy or adverse reactions …. and shall report any problems to the physician.” Review of Patient #1’s medical record revealed start of care on 09/20/2019 with primary diagnosis of Ulcerative Colitis. POC (Plan of Care) orders revealed “SN (Skilled Nurse) to initiate peripheral IV (intravenous) access and administering of IV infusion Entyvio every 6 weeks.” Patient #1’s current medication list revealed “Epinephrine (Anaphylaxis) Injection Solution 1mg (milligram) /ml (milliliter) PRN (as needed) for Anaphylaxis reaction to IV medication Entyvio effective 09/20/2019”. During home visit on 12/03/2024 from 4:27PM to 5:30PM the following was observed: At 4:45 PM RN (Registered Nurse) C was observed initiating IV infusion for Patient #1. At 5:10 PM, during IV infusion, RN C was observed completing form titled “ENTYVIO (Vedolizumab) Infusion Nurse Report, Pre-infusion Assessment”. At 5:15 PM, RN C was observed disconnecting Patient #1 from IV infusion. RN C was then observed instructing Patient #1 to retrieve “emergency kit”. Patient #1 provided emergency kit to RN C who then opened sealed plastic bag with label “Rochester IV Infusion” and reviewed 2 ampules labeled “Epinephrine Injection, USP 1mg/ml” with expiration date of “08/2024”. RN C was then observed placing ampules back into plastic bag and handing to Patient #1. RN C failed to report identification of expired Epinephrine to Patient #1’s provider or clinic and obtain guidance on medication use. Review of document titled “ENTYVIO (Vedolizumab) Infusion Nurse Report” completed by RN C on 12/03/2024 during home visit revealed under heading “Pre-Infusion Assessment” RN C marked check box for “Emergency kit check” and line for expiration date noted “08/2024”. RN C documented on form next to expiration date “Informed patient and family”. Review of Patient #1’s medical record on 12/04/2024 revealed no documentation of communication with provider or clinic following home visit on 12/03/2024. During interview with Executive Director A on 12/04/2024 at 11:30 AM, when asked what the expectation is of the nurse when identifying an expired medication in the home, Executive Director A stated, “Typically the nurse will complete this assessment form and submit it the clinical manager to review.” Executive Director A stated, the Clinical Manager will then contact the clinic to order a new emergency kit and will contact the family to provide education and follow up. Executive Director A stated, “[Clinical Manager D] is currently out seeing patients this morning but has been made aware of the expired medication and will be following up with this when she/he returns to office.””