Mohs Micrographic Surgery Laboratory

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of 2023-2025 laboratory records including the Mohs Log Book, Mohs Slides, Chart/Progress notes, and interivew with laboratory personnel, it was determined that the records failed to maintain accuracy in specimen identification. Findings included: a. MOHS CASE NUMBER ID Mohs Log Book Mohs Slides ------------------------------------------ 23-057 Error: 23-056 23-058 Error: 23-057 b. MOHS LOG BOOK 1. For Mohs Case # 25-382, the Log Book recorded II Stages, but the Chart notes and Mohs Map specified III Stages (11/14/25). c. CHART NOTES 1. Mohs Case # 23-325: the anatomical site was not identified in the patient's chart (11 /10/23). 2.. Mohs Case # 23-009: the anatomical site was identified as Left nose in the patient's chart, but identified as Right Nose in the photograph, Mohs Map, and Mohs Slides (1/12/24). d. The laboratory person affirmed (11/17/25 at 4:30 PM) the aforementioned findings. e. The relaibility and quality of specimen identification throughout the records could not be assured during this Survey. The laboratory performed 400 Mohs procedures annually (CMS116 CLIA Application, 11/14/25). . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an 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 -- 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: Based on the findings and deficiency cited (D5787), it was determined that the laboratory failed to establish reliable review processes to ensure the accuracy, reliability, and quality of their records pertaining to Mohs procedures. Findings included: a. Problems found during this Survey occurred in 2023, but were not detected or corrected in 2023. b. Problems occurred in 2024, but were not detected or corrected in 2024. c.. Problems occurred in 2025, but were not detected until this Survey of laboratory records. d. See D5787. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patients test records, checking of the solution used in patient testing and interview with the laboratory staff on March 25, 2022, at 11:50 am, the laboratory used expired KOH solution in patient testing. The findings include: 1. The laboratory performed fungal test on 3/14/2022 on 2 patients' samples in which it used expired KOH solution. The used KOH solution was expired on 2/28/2022. The test results of both patients were negative. Since the laboratory used an expired solution to test patients' sample, therefore, the accuracy of the reported negative results can not be assured. 2. The laboratory staff on March 25, 2022, at 11:50 am, affirmed that the laboratory used an expired KOH solution to test patients' sample. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/25/2022, stated that the laboratory performs approximately 125 tests, annually. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel 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 -- meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patients test records, checking of the solution used in patient testing and interview with the laboratory staff on March 25, 2022, at 11:50 am, the laboratory director failed to ensure the laboratory's compliance with the CLIA regulations. The findings include: See D5417. -- 2 of 2 --

Summary Statement of Deficiencies 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of patients test records, the Laboratory Personnel Report (CLIA)[10 /15/19], and the laboratory policy for quality assessment of histopathology testing; and interview with laboratory personnel, it was determined that the laboratory failed to establish a policy and process for assessing quality and at least twice annually verify the accuracy of Mohs procedures performed by additional testing personnel. Findings included: a. Review of Mohs records and the CLIA Personnel Report revealed procedures were performed by additional Mohs surgeons, as follows: Mohs surgeon Dates ----------------------------------------------------- Testing Person - 5 2019: July Testing Person - 6 2019: August, September, October b. Laboratory personnel affirmed (10/18/19 at 12:00pm) that the policy and practice of "peer review" of Mohs slides had been specific to Testing Person-1; and that no policy or process had been established to verify the accuracy of Mohs procedures performed by the additional Mohs surgeons, Testing Persons 5 & 6. c. The reliability, quality, and accuracy of Mohs procedures performed by Testing Persons 5 & 6 had not been assured. 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 --