Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency records for 2017, 2018 and interview with the laboratory director, the laboratory failed to verify the accuracy of 6-acetylmorphine (6AM) twice annually. Findings: 1. Review of proficiency records for 2017 and 2018 revealed the laboratory failed to prove accuracy on the nonregulated analyte, 6AM. 2. Interview with the laboratory director on September 27, 2018 at 10:00 AM confirmed the laboratory failed to twice annually verify the accuracy of the nonregulated analyte, 6AM for 2017 and to date 2018. 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)