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 record review and staff interview with the laboratory manager (LM), the laboratory director (LD) failed to sign the attestation sheet for the American Proficiency Institute (API) proficiency testing (PT) samples in the specialties of Hematology and Chemistry. Findings include: 1. Record review on 2/2/2022 of the laboratory's PT attestation sheets for API Hematology and Chemistry Surveys for the 2nd and 3rd events 2020, and the 1st, 2nd, and 3rd, events of 2021, revealed the LD did not sign the attestation sheets. The attestation sheet was signed by the LM who does not qualify as a technical supervisor. 2. Staff interview on 2/2/2022 at 11:30 AM with the LM confirmed the above findings. 3. The laboratory performs 21,141 tests annually in the specialty of Hematology and 100,676 tests annually in the specialty of Chemistry. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)