Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records, and interview with the Laboratory Manager (LM) the laboratory failed to ensure that all Testing Personnel (TP) who performed Chemistry testing participated in all PT events from the AAB Medical Laboratory Evaluation from 9/18/23 to 4/29/25. The findings include: 1. Surveyor review of PT records revealed: a) Only one TP performed the Chemistry PT event M1 in 2025. b) Only one TP performed the Chemistry PT events M1, M2 and M3 in 2024 c) Only one TP performed the Chemistry PT events M2 and M3 in 2023 2. There were twenty one TP listed on the CMS 209 form. 3. The LM confirmed on 4/29/25 at 1:45 pm that the laboratory failed to rotate all TP to participate in all Chemsitry PT events in 2023, 2024 and 2025. 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 --