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 2016 and 2017 AAB (American Association of Bioanalysts) proficiency testing records and interview with TP (testing personnel) 3/6/18, the laboratory director and testing personnel failed to attest to the integration of proficiency samples into the laboratory's routine patient workload. Review of 2016 and 2017 AAB proficiency testing records revealed the names of the laboratory director and TP who tested the samples were typed on the attestation statement for each event, but the attestation statements had not been signed. During interview at approximately 11:30 a.m., TP #1 stated they were unaware the attestation statements had to be signed. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of 2016 and 2017 AAB (American Association of Bioanalysts) proficiency testing records and interview with the laboratory director 3/6/18, the laboratory failed to document evaluation of all ungraded proficiency testing results. Review of 2016 and 2017 AAB proficiency testing records revealed the key at the 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 -- bottom of the proficiency testing results states "? = This score may not truly evaluate performance for this specimen which was not graded because of lack of participant consensus." Review of 2016 and 2017 AAB proficiency testing records revealed the following ungraded results with no evaluation documented: a. 1 of 2 forward progression samples on the 2016 2nd event; b. 1 of 5 sperm cell identification samples on the 2017 2nd event. During interview at approximately 11:25 a.m., the laboratory director stated they were unaware they needed to evaluate results flagged with "?" (ungraded results). 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)