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 laboratory proficiency testing procedures and records, laboratory procedure manual and laboratory director (LD) interview 07/27/21, the laboratory failed to ensure they either participated in a proficiency testing program or participated in a system to verify the accuracy of the Potassium Hydroxide (KOH)/wet prep test results at least twice a year. Findings: Review of the laboratory proficiency testing records revealed no documentation for the participation in a system to verify the accuracy of KOH/wet prep at least twice a year. Review of the laboratory's proficiency testing section in the "Quarterly QA Checklist" states "PT results are available for the prior two years." No documentation was found showing enrollment in a proficiency testing program for KOH/wet prep for 2019, 2020, or 2021. Review of the laboratory's "Proficiency Testing" forms, revealed documentation for "MOHS Micrographic Surgery Form " only, there was no form or documentation for KOH/wet prep proficiency testing. Review of the laboratory's procedure manual revealed there was no procedure for performance of accuracy for KOH/wet prep. Interview at approximately 12:00 p.m. with LD confirmed that the lab did not participate in KOH /wet prep proficiency testing at least twice a year. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)