The Dermatology Group Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at The Dermatology Group PA on June 16, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation, review of the procedure manual and the Clinical Laboratory Improvement Amendments (CLIA)Application for Certification, and interview, the laboratory failed to use non-expired reagents (dyes) for orienting and mapping surgical tissue according to the yellow stickers from 03/15/2025 to 06/16/2025. Findings: 1. Observations during a tour of the laboratory on 06/16/2025 at 9:30 AM, revealed the dyes used for orientation and mapping of the patients' surgical tissues were expired. No other dyes were located in the laboratory. 2. Observation of the Red Tissue Marking Dye lot #154023 listed the manufacturer's expiration date was 07/31 /2024. Review of the red dye bottle showed two labels were attached to the bottle. The white label showed the red dye was received on 10/22/2022 (as I see it) and the expiration date was 07/2024. The yellow sticker covering the manufacturer's expiration date showed the received date was 07/2024, the date opened was 5/15 /2025, and the expiration date was 07/31/25. 3. Observation of the Green Tissue Marking Dye lot #164883 listed the manufacturer's expiration date was 03/31/2025. Review of the bottle of green dye, with a yellow sticker covering the manufacturer's expiration date, showed the received date was 07/2024, the date opened was 05/15 /2025, and the expiration date was 08/31/2025. 4. Observation of the Blue Tissue 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 -- Marking Dye lot #152500 listed the manufacturer's expiration dates was 06/30/2024. Review of the bottle of blue dye, with a yellow sticker covering the manufacturer's expiration date, showed the received date was 10/2024, the date opened was 3/15 /2025, and the expiration date was 07/31/25. 5. Comparison of the expirations date on the manufacturer's label and the open date on the yellow stickers showed all three dyes were expired before they were used according to the yellow stickers. 6. Review of the procedure titled Histopathology - Mohs Surgery noted "Do not use reagents after expiration date. 7. Review of the CLIA application listed the laboratory had an annual test volume of 300. 8. During an interview on 06/16/2025 at 9:40 AM, the Site Manager confirmed the dyes were expired, 9. During an interview on 06/16/2025 at 10:02 AM, the Site Manager stated the Mohs Technician did not give her an explanation as to why she covered up the expiration dates on the dyes and wrote in new expiration dates. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel record, and interview, the Technical Supervisor failed to document the competency evaluation of one of one high complexity Testing Personnel (A) from April 15, 2023 to June 16, 2025. Findings: 1. Review of the personnel records for Testing Personnel A (Mohs Surgeon) showed there was no documentation of annual competency evaluations on the Mohs Surgeon. 2. During an interview on 04/29/2025 at 11:35 AM, the Site Manager stated did not have any documentation of competency evaluation on the Mohs Surgeon. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record the temperature and humidity of the room where testing was performed from 10/23/17 to 2/22/19. Findings: The manual for the Leica CM1530 cryostat noted that the room temperature of the laboratory should be, "consistently 18 degrees Celsius (C)-35 degrees C." The manual also noted that the relative humidity of the laboratory should be a "relative humidity, maximum 60%." A review of the laboratory's logs showed that the laboratory failed to record the temperature and humidity of the room where testing was performed On 2/22/19 at 10:50 AM, Testing Personnel D stated that they did not record the room temperature or the humidity of the laboratory. 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 --