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 review of 2021, 2022 and 2023 proficiency testing (PT) records, lack of documentation and testing personnel (TP) interview 5/24/23, the laboratory failed to ensure TP whom performed the PT testing and the laboratory director (LD) signed attestation statements for 13 of 13 PT events reviewed. Findings: Review of 2021, 2022 and 2023 PT records for Hematology and Microbiology revealed no documentation of attestation statements for 13 of 13 PT events in which the laboratory participated. Interview with TP #2 at approximately 11:20 a.m. confirmed TP whom participated in PT and the LD did not sign attestation statements for 13 of 13 PT events. 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 review of 2022 and 2023 microbiology PT records and TP interview 5/24 /23, the laboratory failed to ensure all unacceptable PT results were evaluated to ensure