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 upon review of 2021, 2022 and 2023 CAP PT (Proficiency Testing) records and interview with the TC (Technical Consultant) on 10/11/2023, the laboratory failed to include 2 of 6 TP (Testing Personnel) in the participation of 6 Clinical Microscopy challenges received from their PT provider during these years. Findings: Review of the 2021, 2022 and 2023 CAP PT records reveal that TP #1 and TP #2 did not participate in any of the 6 Clinical Microscopy PT events completed by the laboratory. Review of the Attestation Forms for these 6 events did not bear any evidence of their participation. During interview at approximately 11:00 a.m., the TC confirmed the absence of participation in Clinical Microscopy PT events by TP #1 and TP #2. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --