Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on August 9, 2022. 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. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of the 2021 American Proficiency Institute (API) proficiency testing records, a review of the director approved proficiency testing policy, and an interview with the laboratory director, and with the lead medical assistant, the laboratory failed to ensure that the proficiency testing samples were tested the same number of times as patient specimens. Findings include: 1. A review of the 2021 API Immunology/Immunohematology test event three for the Rh slide test revealed that two testing personnel signed the attestation stating that the specimens were tested in the same manner as patient specimens, and that specimens RH-11, RH-12, RH-13, RH-14 and RH-15 were tested by both testing personnel. 2. The director approved policy and procedure entitled, "Laboratory Proficiency Testing" stated on page 2, "The API specimens should be tested as we test real patient specimens following the testing protocols in our office." 3. During an interview with the laboratory director, and the lead medical assistant conducted on August 9, 2022 at approximately 10:15 AM, the lead medical assistant stated that two testing personnel routinely perform the API samples to confirm that the results obtained are accurate prior to submission of the results to API. The lead medical assistant and the laboratory director confirmed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- that patient specimens are routinely testing one time by one testing personnel. The laboratory performs approximately 1320 immunohematology tests annually. -- 2 of 2 --