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 testing (PT) and verification of accuracy records since the last survey on 6-8-17 and confirmation by Testing Personnel #1, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to verify the accuracy of mycoplasma testing performed on the moderate complexity Meridian Bioscience ImmunoCard Mycoplasma test kit, at least twice annually, since 6-8-17. Findings include: Review of proficiency testing records revealed PT is not performed for mycoplasma testing. Review of verification of accuracy records since 6-8-17 revealed the accuracy of mycoplasma was verified by sending a split sample to the laboratory's reference lab on 8-17-17, 6-22-18, and 4-5- 19. Testing Personnel #1 confirmed verification of accuracy for mycoplasma testing was not performed twice annually for 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) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)