Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 06/05/2023 and concluded on 06/05/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. 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 document review and interview, it was determined that Mohs examinations were not included in the list of tests or procedures in subpart I of the CLIA regulations. Therefore, they were subject to the requirements for accuracy verification twice annually. The accuracy of the Mohs examinations was being evaluated once annually. Findings included: A review of a laboratory "Procedure and Form 10: Mohs Surgery" document, signed by the Laboratory Director (LD) on 06/26/2020, revealed it lacked a procedure for performing the required twice-annual accuracy verification of Mohs examinations. A review of the laboratory manual revealed it contained instructions from the "American Society for Mohs Surgery," dated January 2022, for submitting case reviews. The instructions indicated a case was to be submitted once per year. Also included in the procedure manual were the results from a single case review performed for 2022. During an interview on 06/05/2023 at 11:30 PM, the LD stated she was unaware of the requirement for twice-annual accuracy verification for the performance of Mohs examinations. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --