Every finding on record at John C Fremont H C Dist HHA

The following reflects the findings of the California Department of Public Health, during a STANDARD recertification survey conducted on 9/18/23 to 9/25/23. Representing the California Department of Public Health: 27390 RN, HFEN Sample size : 7 Record review home visits : 3 Record Review with no home visits : 4

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, interview and record review, the agency failed to ensure all patient medications were reviewed for one of three sampled patients with home visit (Patient 3) when Registered Nurse (RN) 1 did not ensure Patient 3 was taking insulin glargine (an injectable long-acting modified form of medical insulin used in the management of diabetes-a metabolic disorder in which the body has high sugar levels for prolonged periods of time.) as prescribed. This failure had the potential to result in Patient 3 experiencing uncontrolled sugar levels which could lead to diabetic coma (life-threatening but reversible form of coma found in people with diabetes). Findings: During an observation on 9/21/23 at 10 a.m., in Patient 3’s home, RN 1 looked at the list of Patient 3’s medications. There were medication bottles displayed on the table in front of RN 1 for easy access. RN 1 reviewed the list and checked each bottle of the medications one by one. RN 1 did not mention to Patient 3 about injectable insulin glargine, which was recommended to be stored in the refrigerator. During an interview on 9/21/23 at 10:30 a.m., in Patient 3’s home, Patient 3 stated she controlled the condition with diet, pill and the insulin injection. Patient 3 brought out the medication (insulin glargine) from refrigerator. Patient 3 stated she was injecting the insulin under the skin 25 units (unit of measure) every night. Patient 3 stated she used to inject 15 units for 3-4 months, but the doctor increased the dose to 25 units since the oral pill gave her diarrhea (loose stools). During a review of Patient 3’s “Medication Profile" dated 9/21/23, the medication profile indicated, “Start date: 03/08/2023 Medication: [insulin glargine brand name] Subcutaneous 100 Unit/ML [milliliter - unit of measure] 15 units ml 15 units SC (subcutaneous-under the skin) daily ANTIDIABETICS.” During an interview on 9/25/23 at 2:40 p.m., with the interim Administrator/Director of Patient Care Services (Adm/DPCS), the Interim Adm/DPCS stated RN 1 should have checked all current medications during each visit and updated medication profile to identify potential drug interaction and duplicate therapy. The Interim Adm/DPCS stated since Patient 3’s primary diagnosis was diabetes it was important to check the current dose of insulin injection to assess the efficiency of insulin therapy without the side effect of hypoglycemia (low blood sugar level). During an interview on 9/25/23 at 3 p.m., with RN 1, RN 1 stated Patient 3 had the tendency to change the medication dose on her own and she was too stubborn to listen to him. RN 1 stated he forgot to check insulin glargine during the home visit on 9/21/23. RN 1 stated he should have asked Patient 3 how many units she was injecting and he should have validated the change of dose with the physician. RN 1 stated overdose of insulin injection could lead her to diabetic coma. During a review of Patient 3’s plan of care (POC-list of services and supplies that a home health agency will provide to a patient, based on a comprehensive clinical assessment and the identification of patient-specific goals and outcomes) from 09/13/23 to 11/11/23, the POC indicated the start of care was 3/17/23 and the primary diagnosis was type 2 diabetes mellitus (a condition results from insufficient production of insulin, causing high blood sugar.) with foot ulcer. During a review of the agency’s policy and procedure (P&P) titled, “Medication Profile” dated 7/1/05, the P&P indicated, “... Each nurse who sees a patient reviews the medication profile and updates it appropriately ...”

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 interview and record review the agency failed to provide reliable laboratory test for seven of seven sampled patients when the agency collect the laboratory specimen without CLIA (Clinical Laboratory Improvement Amendment - federal regulatory standards that applied to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research) Certificate of Waiver as federal law required. This failure placed patients at a risk of their point of care laboratory testing being not done with the standards for timeliness, accuracy, and reliability of laboratory test result. Findings: During a concurrent interview and record review on 9/25/23 at 2:40 p.m., with the interim Administrator/Director of Patient Care Services (Adm/DPCS), the interim Adm/DPCS stated Registered Nurse (RN) 1 had a home visit to Patient 3 to draw blood for laboratory test on 9/22/23. The interim Adm/DPCS presented a copy of CLIA, not a waiver. The interim Adm/DPCS stated she started her position on June 2023 and was in the process of reviewing official documents and revising the agency’s old policy and procedure to meet the current requirements. A review of agency’s CLIA by the interim Adm/DPCS, indicated it was issued to [the acute hospital] and it was not a Waiver. The interim Adm/DPCS stated she knew the home health agency required to have CLIA Wavier to allow the agency's staff to collect blood or urine samples and perform limited laboratory during the home visits. During a review of the agency’s job description titled “Administrator” dated 8/23/23, the job description indicated, “... The Administrator of the Agency has the following responsibilities: Complying with applicable laws and regulations …”