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 the lack of proficiency testing (PT) attestation forms from the provider American Proficiency Institute (API) performed from 5/19/22 to 2/14/24 and interview with the technical consultant (TC), the laboratory failed to attest on five of five events that proficiency testing samples were handled in the same manner as patient samples. Findings: 1. Request was made for the API attestation forms from 5 /19/22 to 2/14/24 for five events. No attestation documents were provided at the time of survey for the following: a. 2022 Hematology/Coaguation 2nd Event July 25,2022 b. 2022 Hematology/Coaguation 3 rd Event November 18, 2022 c. 2023 Hematology/ Coagulation 1st Event March 27,2023 d. 2023Hematology/ Coagulation 2nd Event August 1, 2023 e. 2023 Hematology/ Coagulation 3rd Event November 23, 2023 2. Interview with the TC on 2/14/2024 at 2:30 p.m. confirmed, the laboratory failed to attest on five of five events that proficiency testing samples were handled in the same manner as patient samples. 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 --