Summary:
Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of 2020 and 2021 American Proficiency Institute (API) hematology proficiency testing (PT) records, and interview with testing personnel (TP #1) 3/10/22, the laboratory failed to test PT samples in the same manner as patient specimens for 6 of 6 hematology PT events reviewed. Findings: Review of laboratory policy revealed "Concerns regarding CBC's will be brought to the provider's attention promptly, and will only be repeated if instructed by the provider's." The policy fails to specify if critical or flagged results should be repeated. The policy also fails to define the criteria for acceptance if samples were repeated. Review of 2020 and 2021 APT PT records revealed PT samples were repeated at least twice in 6 of 6 Hematology API PT events. For example; 1. 2021 3rd API PT event records revealed all samples were repeated 4 times. 2. 2021 1st and 2nd API PT event records revealed all samples were repeated 3 times. 3. 2020 2nd API PT event records revealed all samples were repeated 3 times. 4. 2020 1st API PT event records revealed all samples were repeated 2 times. Interview with TP #1 at approximately 1:00 p.m. confirmed the laboratory failed to test PT samples in the same manner as patient 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 -- specimens. She also confirmed the laboratory did not have a policy stating specifically when a patient specimen should be repeated or the criteria for acceptance if samples were repeated. -- 2 of 2 --