Summary:
Summary Statement of Deficiencies 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 review of the College of American Pathologists (CAP) Proficiency Test (PT) records and interview with the testing person (TP), the laboratory failed to perform bacteriology PT for all personnel who perform throat culture patient specimen testing. FINDINGS: 1. CAP bacteriology PT samples were tested by the same TP in the first and second events of 2022 as well as all three events for 2023. The PT samples were not rotated among the other eight TP who routinely performed throat culture patient specimen testing. 2. The TP confirmed the findings on March 4, 2024, at approximately 10:00 A.M. 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 review of the CAP PT records and interview with the TP, the PT attestation forms confirming that PT samples were tested in the same routine manner as patient specimens were not signed. FINDINGS: 1. CAP PT attestation forms for the first and 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 -- second events of 2022 as well as all events for 2023 were not signed by the laboratory director (LD) and TP. 2. TP confirmed the findings on March 4, 2024, at approximately 10:00 A.M. It could not be determined if PT samples were tested by TP in the same manner as patient specimens. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of twice year verification records and interview with the TP, the laboratory failed to perform and document urine colony count twice year verification interpretation. FINDINGS: 1. There was no documentation of twice year urine colony count verification records for 2023. 2. The TP confirmed the findings on March 5, 2024, at approximately 10:30 A.M. 3. Approximately 101 urine colony count patient samples were tested in calendar year 2023. -- 2 of 2 --