Summary:
Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on June 21, 2022. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 review of hematology proficiency test (PT) records and interview with the laboratory general supervisor (GS), the laboratory failed to rotate PT samples between testing personnel. Findings include: 1. Review of hematology PT records of : 2020 Event #3; 2021 Events # 1, 2, & 3; and 2022 Event #1 revealed staff #4 (CMS 209) performed and attested to performing the aforementioned PT events. 2. Interview with the GS (CMS 209), on 6/21/22, in the research office, at approximately 1 PM, confirmed staff #4 (CMS 209) performed the aforementioned PT events. 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 --