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 observation of the Microscope, Leica DM1000 LED (serial number 448883), review of 2023 laboratory records for Mohs procedures, the lack of records, and interview with laboratory personnel, it was determined the laboratory failed to verify the accuracy of procedures performed in 2023. Findings included: a. Mohs procedures were performed in 2023, as follows Date Case # Mohs Surgeon ----------------------------------------- 1/16/23 00-111 Dr. S 2/24/23 00-138 Dr. C 3/06/23 00-144 Dr. S 3/31/23 00-151 Dr. C b. The laboratory failed to have records verifying the accuracy of procedures performed by Dr. S and Dr. C in 2023. c. Laboratory personnel affirmed (10/15/25 at 1:00 PM) the aforementioned findings, and that Dr. S and Dr. C performed multiple Mohs procedures in 2023. d. The reliability and quality of Mohs procedures performed by Dr. S and Dr. C in 2023 could not be assured during this Survey. e. The laboratory performed 350 Mohs procedures annually (CMS116 CLIA Application, 10/14/25). . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: 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 -- Based on the findings and deficiency cited, review of laboratory procedure for quality assessment, and interview with laboratory administrative personnel, the laboratory is herein cited for failing to follow written policies and procedures to correct errors identified during self-audit quality assessment. Findings included: a. Laboratory administrative personnel affirmed (10/15/25 at 1:00 PM) the findings and non- compliance cited at D5217. b. The laboratory had a written policy and procedure for quality assessment and assurance. c. Laboratory administrative personnel affirmed (10 /15/25 at 1:00 PM) performing the self audit in preparation for this Survey and identifying the error, and that no action was taken to correct the problem. d. The reliability and quality of the laboratory's policy/procedure to ensure quality and compliance was not assured during this Survey. -- 2 of 2 --