Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of Hematology quality control (QC) logs, patient CBC (Complete Blood Count) records and an interview with the Technical Consultant and Testing Personnel #1, the laboratory failed to ensure testing personnel checked expiration dates, and did not utilize expired QC material on days of patient testing. Expired controls were used on three days of patient CBC testing in March 2021 by two different testing personnel. The findings include: 1. A review of Hematology records revealed expired QC material was used on the Medonic M Series Hematology analyzer 3/23/2021 through 3/30/2021 (eight days) by two previous testing personnel. 2. During an interview on 2/24/2022 at 1:50 PM the Technical Consultant confirmed the above noted findings. The surveyor then asked if patient CBC's were performed on these eight days. Testing Personnel #1 checked the patient records, and stated three patient CBC's were run on 3/25/2021, one patient on 3/26/2021, and two patients on 3 /30/2021. . D5783