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 the "FASMA Molecular NGS Assay Blind Sample Policy" and interview with the technical supervisor, the laboratory's written procedure did not define how many samples would be sent for culture comparison, and did not define acceptable limits of the comparison and remedial actions to be taken when results are not within acceptable limits. Findings: During the exit interview on 03/01/19 at 11:00 AM the technical supervisor confirmed that the "FASMA Molecular NGS Assay Blind Sample Policy" did not include how many samples would be sent for culture comparison, and did not define acceptable limits of the comparison and remedial actions to be taken when results are not within acceptable limits. 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)