Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American Proficiency Institute (API) and an interview with the general supervisor (GS) on 8/3 /2022, the laboratory failed to have testing personnel and the laboratory director attest to the integration of PT samples with routine testing of patient samples for the specialty microbiology in 2022. The findings include: 1. A review of PT results for Influenza A, Influenza B and SARS-CoV-2 from API identified that the laboratory failed to have the performing testing personnel and the laboratory director attest that the PT samples were testing with patient samples for events one (1) and two (2) in 2022. 2. An interview with the GS on 8/3/22 at 1:35 pm confirmed that the laboratory failed to sign attestations for events one (1) and two (2) in 2022. 3. The laboratory reports performing 50,000 microbiology tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American Proficiency Institute (API) and an interview with the general supervisor (GS) on 8/3 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 -- /2022, the laboratory failed to document the review of PT results for the specialty of microbiology. The findings include: 1. A review of PT documents for the specialty of microbiology from API identified that the laboratory failed to document the review and evaluation of PT results by the laboratory director for event one (1) in 2022. 2. An interview with the GS on 8/3/2022 at 1:35 pm confirmed that the laboratory director failed to document the review and evaluation of PT results for microbiology event one (1) in 2022. 3. The laboratory reports performing 50,000 microbiology tests annually. -- 2 of 2 --