Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA validation survey conducted at your facility on March 19, 2024. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the 2022 and 2023 College of American Pathologists (CAP) Proficiency Testing (PT) records for the critical care/aqueous blood gas specimens, and an interview conducted on March 19, 2024 at approximately 11:00 AM with the technical consultant numbers 1 and 3 listed on the CMS-209 form, the laboratory failed to ensure that the proficiency testing specimens were rotated among the routine testing staff for the 2023 test events two and three. Findings include: 1. A review of the 2023 CAP PT attestation records for the Critical Care/Aqueous Blood Gas specimens revealed that technical consultant number 3 listed on the CMS-209 form performed the proficiency testing for the 2023 test events two and three. 2. The Technical Consultants numbers 1 and 3 confirmed the findings during an interview conducted on March 19, 2024 at approximately 11:00 AM. The laboratory performs approximately 50,000 hematology and chemistry tests annually. 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 --