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) from the provider College of American Pathologists (CAP) performed 8/26/2020 to 3/1/2022 and interview with the laboratory director (LD), the LD failed to attest that proficiency testing samples were handled in the same manner as patient samples on eight of eight events. Findings: 1. Review of the attestation pages for PT from CAP revealed no signature of the LD or designee was present on: a. 2020-SO-C, Blood Oximetry b. 2020-AQ-C, Critical Care Blood Gas c. 2021-SO-A, SO-B, and SO-C, Blood Oximetry d. 2021-AQ-A, AQ-B, and AQ-C, Critical Care Blood Gas 2. Interview with the LD on 3/9/22 at 10:05 a.m. confirmed, the LD failed to attest that proficiency testing samples were handled in the same manner as patient samples on eight of eight events. 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 --