Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Forefront Dermatology Dc Corp Dba Knight Dermatology on 5/4/2026. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview, the laboratory failed to verify the accuracy of its Mohs histopathology testing at least twice yearly in the 2025 calendar year. Findings include: 1. Peer Review documentation for the first semi-annual cycle of 2025 showed that patient slides were sent out for review in July 2025; however, there was no record of the results being received, reviewed, or evaluated by the laboratory to verify the accuracy of the testing. 2. Documentation for the second semi-annual cycle of 2025 showed that patient slides were sent out in December 2025; however, the results were not received back by the laboratory until March 2026. 3. In an interview on 05/04/2026 at 11:00am, the Practice Manager acknowledged that the July results were missing and that the December results were not received until March 2026, resulting in a failure to complete the two required accuracy verification cycles for 2025. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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, 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 -- 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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 monitor and document room temperature and humidity and equipment temperatures (cryostat) for 1 day (07 /29/2025) on which patient testing was performed. Findings include: 1. The laboratory policy titled "M-721-E-ii Lab Thermometer" states: "When the Mohs lab is opened for the day, the lab thermometer which displays the lab temperature and humidity is checked... documents the temperature and humidity completed by initialing Log 722- B Room Temp/Humidity." 2. A review of the "Log 722-B Room Temp/Humidity" and "Cyrostat Maintenance & Temperature" logs on 05/04/2026 revealed that the laboratory failed to record environmental and equipment temperatures for 07/29/2025. 3. A review of the "Mohs Accession Log" on 05/04/2026 confirmed that patient testing was performed on 07/29/2025. 4. In an interview on 05/04/2026 at 11:00am with the Practice Manager confirmed that patient testing occurred on 07/29/2025 and acknowledged that the room temperature, humidity, and cryostat temperatures were not documented. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform and document daily quality control (QC) for Hematoxylin and Eosin (H&E) staining for 2 days (07 /29/2025 and 03/03/2026) on which patient testing was performed, out of 17 testing days reviewed. Findings include: 1. The laboratory policy titled "Hematoxylin and Eosin Stain" (Revised 01/15/2019) states: "The first slide of the day will be submitted to the Mohs surgeon for the completion of the daily quality control... The slide will be stained for H&E and documented on the control sheet." 2. A review of the "Mohs Accession Log" on 05/04/2026 established that patient testing was performed on eight days in July 2025 (7/1, 7/7, 7/8, 7/14, 7/21, 7/22, 7/28, and 7/29) and nine days in March 2026 (3/2, 3/3, 3/9, 3/10, 3/16, 3/23, 3/24, 3/30, and 3/31). 3. A review of the laboratory's "Hematoxylin & Eosin Quality Control Log" on 05/04/2026 revealed that the laboratory failed to document the required slide QC for the following dates on which patient specimens were processed: 7/29/2025 & 3/3/2026 4. In an interview on 05/04/2026 at 11:00am, the Practice Manager confirmed that patient testing occurred on 07/29/2025 and 03/03/2026 and acknowledged that the daily QC slides were not documented for those dates. -- 2 of 2 --