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 the review of the laboratory's established policy titled, Quality Assurance (QA) Proficiency Testing (PT), review of the QA PT forms for 2019, lack of records for 2020, 2021 and an interview with the practice manager, the laboratory failed to verify the accuracy of the Moh's slides twice annually for the calendar years 2020 and 2021. FINDINGS: 1. The laboratory failed to verify the accuracy of the Moh's slides twice annually, as required by the QA policy which states," Frozen slides are randomly selected from biopsy and Moh's cases diagnosed during the months (Selected) . I am requesting your professional evaluation to verify diagnosis made by (Moh's Surgeon Name) as well as the quality of work performed at this laboratory. 2. The laboratory failed to provide the requested twice annually documentation for the calendar years 2020 and 2021. 3. The last date of the recorded QA was performed on April 10, 2019, by the Moh's prior Moh's surgeon for the following cases: a. PC19-05; PC19-09; PC19-26 4. The practice manager confirmed on February 18, 2022, at approximately 11:15 AM that the laboratory failed to verify the accuracy of the Moh's slides twice annually in the calendar years 2020 and 2021. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's QA PT policy, the QA PT forms for 2019, lack of QA records for 2020, 2021 and an interview with the practice manager, the laboratory director failed to maintain the QA program and identify the failure to verify the accuracy of the Moh's slides twice annually for the calendar years 2020 and 2021. Refer to D5217. -- 2 of 2 --