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, the laboratory failed to attest that proficiency testing (PT) samples were performed in the same manner as patient specimens. Findings include: 1. Record review on 1/19/22 of the 2021 American Association of Bioanalysts PT documents for Semen analysis (SA-event 1) and Endocrinology tests (Chemistry/Non-Chemistry-event 2) attestation pages revealed the pages were not signed by the laboratory director (LD). 2. Staff interview with the LD on 1/19/22 at 2:15 PM confirmed the above finding. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow its procedure manual for calibration verification for the laboratory tests in the subspecialty of endocrinology. Findings include: 1. Record review of the laboratory's procedure manual for calibration verification on 1/19/22 for the Tosoh analyzer Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- revealed the laboratory must perform calibration verification at least semiannually for the endocrinology tests (Follicle stimulating hormone, Luteinizing hormone, Beta human chorionic gonadotropin, Estradiol and Progesterone). 2. The laboratory did not have documentation for the Tosoh analyzer semiannual calibration verification. 3. Staff interview with the laboratory director (LD) and the testing personnel #1 on 1/19 /22 at 11:45 AM confirmed the above findings. 4. The laboratory performs 5,100 endocrinology tests annually. 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 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)