Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of the American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) Proficiency Testing (PT) records and an interview with the Center Manager (CM)and the Assistant Manager of Quality (AMQ), the laboratory failed to retain the PT program forms for at least two years on five of the six events reviewed in 2023 through 2024. The findings include: 1. A review of the AAB-MLE PT records revealed the lack of PT program forms regarding receipt, storage and testing instructions of shipped PT specimens for the following events. A) Chemistry M1 2023 Event B) Chemistry M2 2023 Event C) Chemistry M3 2023 Event D) Chemistry M1 2024 Event E) Chemistry M3 2024 Event 2. The CM and the AMQ confirmed the above findings during the exit conference on 02-11-2025 at 2:05 PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --