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 January 21, 2020. 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. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review of the director approved policy and procedure manual regarding the evaluation of different instruments performing the same laboratory tests and an interview with the laboratory manager, the laboratory failed to evaluate, at least twice a year, the relationship between the results of two instruments that perform Complete Blood Counts (CBC's). Findings include: The laboratory failed to have a policy, procedure and established criteria for acceptability that would evaluate and define the relationship between test results from the two hematology analyzers used for patient testing. There was no data collected and evaluated to determine if the two hematology instruments would deliver similar results for patient testing. This was confirmed with the laboratory manager on January 21, 2020 at approximately 10:00 AM. The laboratory performs approximately 39,000 patient Hematology 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 --