Rw Dermatology

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with the office manager (OM), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 Fisher Brand Traceable thermometer/humidity monitor used for monitoring room temperature and humidity in the histopathology laboratory from 08/29/2023 to the day of the survey. Findings include: 1. On the day of the survey, 06/10/2025 at 09:30 am, observation of the laboratory revealed the following thermometer used for room temperature and humidity monitoring in the histopathology laboratory was due for maintenance: - 1 of 1 VWR Traceable Thermometer (S/N 200655031) due 10/23/2022. 2. The laboratory failed to provide maintenance/functions checks records for the Fisher Brand Traceable thermometer/humidity monitor from 08/29/2023 to 06/10/2025. 3. The laboratory performed 100 histopathology examinations in 2024 (CMS 116, estimated annual volume). 4. The OM confirmed the findings above on 06/10/2025 at 09:35 am. 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 --

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 peer review records and interview with the Chief Operations Director (COD), the laboratory failed to ensure that the verification of accuracy for Mohs micrographic examinations were performed at least twice annually in 2022. Findings include: 1. On the day of survey, 08/29/2023 at 10:56 am, review of Mohs micrographic examinations peer review records revealed that the evaluation and verification activity was performed once in 2022. 2. The laboratory performed 89 histopathology examinations in 2022 (CMS 116 form). 3. The COD confirmed the findings above on 08/29/2023 around 11:30 am. 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 observation of microscope during the laboratory tour, lack of documents, and interview with the Chief Operations Director (COD), the laboratory failed to provide documentation for annual maintenance on 1 of 1 Lecia DM 750 microscope from 04/2021 to 08/2023. Findings include: 1. On the day of survey, 08/29/2023 at 11: 20 am, a laboratory tour revealed that the laboratory failed to perform yearly 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 -- maintenance on 1 of 1 Lecia DM 750 microscope from 2021 to the day of the survey. 2. The maintenance sticker observed at the time of the survey revealed: Last maintenance completed on: 04/23/2021 Due for maintenance: 04/2022 3. The COD confirmed the findings above on 08/29/2023 around 11:30 am. -- 2 of 2 --