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 the laboratory's proficiency testing (PT) records and interview with the office manager, the laboratory director failed to sign one of two PT attestation statements reviewed for 2023. The findings include: 1. Review of the laboratory's proficiency testing records revealed that the attestation statement was not signed by the laboratory director for one of two events reviewed (2023 event one for hematology). 2. Interview with the office manager on 10.09.2023 at approximately 11: 45 a.m. confirmed the laboratory director had not signed the PT attestation statement for one of two PT events in 2023. 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 --