Dermatology Associates Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates, Inc on October 27, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency cited is as follows: D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures, quality control (QC) records, patient logs, lack of documentation and interview, the laboratory failed to document daily Hematoxylin and Eosin (H&E) stain acceptability for seven (7) days with fifty-six (56) patient Mohs slides stained/processed/evaluated during the twenty- two (22) months reviewed from January 2024 until the date of the survey on October 27, 2025. The findings include: 1. Review of the laboratory's Quality Control procedure revealed a statement, "QA slide will be stained, checked, and documented on the Stain QA Sheet daily..." 2. Review of the "Stain QA Sheet" records from January 2024 to October 27, 2025, revealed a lack of H&E control slide documented for the following 7 dates: 01/17/2024, 02/29/2024, 03/27/2024, 05/16/2024, 05/22 /2024, 05/30/2024, 07/17/2024. 3. Review of the laboratory's Mohs patient logs revealed the following number of patient Mohs slides stained/ processed/evaluated on the 7 days lacking QC slide documentation: 01/17/2024 - 11 patient slides, 02/29 /2024 - 6 patient slides, 03/27/2024 - 9 patient slides, 05/16/2024 - 6 patient slides, 05 /22/2024 - 10 patient slides, 05/30/2024 - 6 patient slides, 07/17/2024 - 8 patient 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 -- slides, A total of 56 patients slides. The surveyor requested to review the documentation of the daily H&E stain acceptability for the above listed dates. The laboratory provided a stained H&E slide for each of the days listed. The laboratory provided no documentation of the QC slide review for the above listed days. 4. In an exit interview with the Mohs Histotechnician on October 27, 2025 at 12:15 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates Inc on October 17, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiency is as follows: 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 a tour, review of manufacturer's guidelines, lack of daily temperature /relative humidity (RH%) documentation, and interviews, the laboratory failed to ensure manufacturer's environmental operating requirements were followed for the Advantik QS12 Cryostat during the twenty (20) of 20 months reviewed from March 2018 until the date of the survey on October 17, 2019. Findings include: 1. During a tour of the laboratory at approximately 9:30 AM, the surveyor noted an Advantik QS 12 Cryostat in use for preparing MOHS specimens for patient testing. 2. Review of the "Advantik QS12 Cryostat Instruction Manual" for environmental operating requirements revealed the following requirements for the QS12 Cryostat: "Temperature (Operating Limits) +5C to +35C (+41F to +95F)" "Relative Humidify Max. 60% RH up to 35C)" 3. Review of the laboratory's records revealed a lack of documentation of the daily temperature and RH% from March 2018 until the date of the survey on October 17, 2019. The surveyor requested to review the daily 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 -- temperature and RH% from March 2018 until October 2019. The laboratory provided no document for review. The MOHS technician stated that he/she monitors the temperature and relative humidity but does not have documentation. 4. In an exit interview with the practice manager and patient advocate at approximately 1:00 PM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates, INC on March 8, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory's procedures, Potassium Hydroxide (KOH) Preparation (Prep) logs, and an interview, the laboratory failed to confirm the accuracy of the KOH Prep test results twice a year in 2016 for five (5) of five (5) testing personnel . Findings include: 1. Review of laboratory's CMS 209: Personnel Report revealed five (5) testing personnel (TP). 2. Review of the laboratory's procedure manual revealed a written policy that states, ""KOH log includes patient information including two of three identifiers, physicians first initial and last name, specimen collection date and time, results, and place for slide peer review." 3. Review of the laboratory's 2016 KOH Prep logs revealed five (5) testing personnel (TP) reported patient results and that the laboratory documented one peer review accuracy check on 2/17/16 for TP A. The inspector requested additional documentation of peer review accuracy checks in 2016. No documentation was available for review for the following five (5) personnel: TP A, TP B, TP C, TP D, TP E. (See Personnel Code Sheet.) 4. An interview with the office practice manager at approximately 12:30 PM confirmed that the laboratory failed to confirm the accuracy of the KOH Prep test results twice a year in 2016. 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 --