Dermatology Associates Of Virginia

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of Virginia on June 18, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory's personnel files, laboratory's policies and procedures, lack of documentation, and an interview, the Technical Supervisor (TS) failed to follow the established laboratory policy to perform a six month competency evaluations for one (1) of six (6) personnel in calendar year 2023. The findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified themselves as Technical Supervisor (TS). 2. Review of the laboratory's policies and procedures revealed a policy for competency evaluations of Histology technicians (histotech) that included initial training and a competency at 6 months of employment. 3. Review of the laboratory's personnel files revealed six (6) personnel performing Histology duties. Personnel A's file revealed an initial training in April of 2023 and an annual competency evaluation in December of 2024. A 6 month evaluation performed in 2023 was requested and not provided. 4. In an exit interview with the Clinical Administrators on June 18, 2025 at approximately 4:15 pm, the above findings were confirmed. 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 D0000 An announced CLIA recertification survey was conducted at Dermatology Associates of Virginia (Midlothian) on August 24-25, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The inspection also included a follow up review of personnel records and interviews with the clinical administrator and laboratory supervisor on 8/28/23-8/29/23. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiency cited is as follows: D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. 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), personnel files, newly installed histopathology tissue processing analyzers' performance qualification records, lack of documentation, review of user guide, and interviews, the technical supervisor (TS) failed to document an approval evaluation/verification for one (1) of two (2) new tissue sample processors after installation in May 2023 as reviewed on the date of the inspection August 24-25, 2023. Findings include: 1. Review of the laboratory's CMS 209 personnel form and personnel files revealed that Testing Personnel (TP) #1 qualified and performed responsibilities of Lab Director (LD) and identified TP #2 qualified and performed responsibilities of TS. * See Personnel Code Sheet. 2. A review of the histopathology analyzer validation records revealed the following 2 new automated processors were installed by field service technical specialists in May 2023: Tissue Tek Sakura Prisma Plus for Histological Hematoxylin & Eosin (H & E - Serial Number 617101041217) on 5/25/23; Roche Benchmark Ultra Plus for 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 -- Immunohistochemistry (IHC - Serial Number 1100222) on 5/30/23. 3. The inspector noted that the initial Roche Benchmark Plus installation validation studies were not evaluated by the LD or TS. The inspector noted a Roche field service specialist notation (dated 5/30/23), "Installation performance qualification completed. All 20 vimentin stained slides show appropriate staining." 4. The inspector requested to review a record of an evaluation/approval of validation studies for reaction/stain quality observations for the new analyzer system outlined above by the TS or LD. The clinical administrator and laboratory supervisor stated on 8/25/23 at 2 PM, "We will get the lab director and technical supervisor to review and sign the initial and preceding validations." 5. Review of the Roche Benchmark Ultra Plus user guide revealed statement, "Product validations should be interpreted by qualified pathologist personnel in conjunction with histological examination, relevant clinical information, and proper controls." 6. A follow up interview with the clinical administrator on 8/29 /23 at 11 AM confirmed the above findings. -- 2 of 2 --