Advanced Dermatology And Cosmetic

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on the review of the laboratory's protocol for Mohs, ten (10) Mohs patient test records, lack of documentation of stain log, and interviews with the office manager (OM) on December 16, 2025; it was determined that the laboratory failed to document the stains used. The findings include: 1. The laboratory's practice was to document all activities at each patient Mohs day schedule that included but not limited to, patient log, quality control, cryostat temperature and preventive maintenance, and stain log. 2. The surveyor reviewed 10 Mohs patient records from October 10, 2023 to November 4, 2025 wherein: a. The stains used on two dates were not recorded: i. On October 10, 2023, had a total of nine patients examined. ii. On November 14, 2023, had a total of fifteen patients examined. 3. During an interview on December 16, 2025 at approximately 1:53 p.m., the OM stated that the "Hematoxylin and Eosin Stain Log" was not included in the documentation that staff checked at each Mohs surgery day. 4. According to the testing declaration form submitted at the time of survey, the laboratory performed and reported 4,000 Dermatopathology cases that included the Mohs slide reviewed for pathology interpretation. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 the surveyor's review of laboratory's policies and procedures, microscope preventive maintenance (PM) documentation, twenty patient records for Dermatopathology test records, and an interview with the office manager (OM) on December 16, 2025; it was determined that the laboratory failed to follow the established policy and procedure for the calibration and preventive maintenance (PM) of the micrscope as defined by the manufacturer, with at least the frequency recommended for the laboratory's equipment prior to patient testing. The findings include: 1.The laboratory's policy for the microscope PM was to have it serviced every six months wherein the second service for 2024 was missed. The gap of service covered from 12/28/2024 to 4/16/2025. 2. No

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's policies & procedures, eight (8) random patients biopsies and Mohs reports, quality control records, proficiency testing records, and interview with the laboratory staff on February 23 2020 at 11:45 a.m.; it was determined that the laboratory failed to verify, at least twice annually, the accuracy of its biopsies and Mohs test for the years 2019 and 2020. The findings included: 1. The laboratory did not have any documentation showing that it had verified its biopsies and Mohs test accuracy for the years 2019 and 2020. Therefore, the accuracy of the laboratory's test results to the patients for biopsies and Mohs procedures, cannot be assured. 2. The laboratory staff affirmed on 2/23/2020 at approximately 1:00 p.m., that the laboratory did not have any record to verify its biopsy and Mohs test accuracy for the years 2019 and 2020. 3. The laboratory's testing declaration form signed by the laboratory director, stated that the laboratory performs 5,000 Histopathology tests including biopsies and Mohs tests annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on review of eight (8) random patient sampling covering a period from 07/5 /2018 to 01/14/2021, review of quality control documents, lack of the current practice laboratory policies and procedures, and interview with the laboratory personnel; it was determined that the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. The findings included: 1. On the day of the survey 02/23/2021 at approximately 12:00 p.m. no documentation could be retrieved to show that the laboratory had written policies and procedures for the current practice. This correction process involves records retention and storage policies, peer review, quality assessment, and policies for preventing problems that have been identified. 2. The laboratory personnel confirmed on 02/23/2021 at approximately 1:20 p.m. that the laboratory did not have written policies and procedures that reflect the current practice for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the general laboratory systems. 3. The annual testing declaration submitted on 02/23/2021 estimated 5,100 tests resulted and reported. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the lack of documentation of the Cryostat temperature used by Mobile Mohs, review of maintenance records, and interview with the laboratory staff; it was determined that the laboratory failed to perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer for the Cryostat used to process samples for the Mohs procedure. The findings included: 1. The laboratory contracts Mobile Mohs Company to process samples for the Mohs procedure. 2. For two (2) out of four (4) random selected Mohs samples processed, no records of temperature and preventive maintenance of the cryostat used to process Mohs samples were found for the following dates: 11/03/2018 and 06/04/2019. 3. The laboratory staff confirmed on 02/23/2021 at approximately 12:30 p.m. that the laboratory failed to follow manufacturer's instruction to document the Cryostat temperature at the time of processing samples for the Mohs procedure on the dates indicated in 1. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the lack of established policies and procedures reflecting the current practice (D5291), failure to establish and follow a peer review policy for the verification at -- 2 of 3 -- least twice annually the accuracy of the biopsies and Mohs procedure for the years 2019 and 2020 (D5217), and the lack of preventive maintenance and temperature records for the cryostat (D5429) it was determined that the laboratory director failed to ensure that testing systems developed and used for each of the biopsies and the Mohs tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. -- 3 of 3 --