Adov Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Elevate Dermatology and Plastic Surgery on September 2, 2026 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Elevate Dermatology and Plastic Surgery was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies are as follows: D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory proficiency testing (PT) documentation, policy and procedures, and interviews, the laboratory failed to retain laboratory director (LD) signed PT attestation sheets for three (3) of four (4) PT events reviewed. Findings include: 1. Review of the laboratory's PT documentation revealed the laboratory participates in American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) PT as Account Number 17169 for Potassium Hydroxide (KOH) microscopy test. Review of the available documentation for the lab's 4 AAB-MLE PT events (2025 M2, 2025 M3, 2026 M1, and 2026 M2) revealed no retention of laboratory director (LD) signed PT attestation sheets for the following three events: AAB-MLE M3 2025, AAB-MLE M1 2026, and AAB-MLE M2 2026. 2. When asked about a PT policy at 10:00 AM, the manager provided Proficiency Testing policy 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 -- whose procedure includes "results will be recorded on the provided report form, which will be signed by the testing personnel and the director." 3. In an exit interview with the manager at 11:05 AM on 9/2/26, the above findings were confirmed. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of laboratory proficiency testing (PT) documentation, policy and procedures, and interviews, the laboratory failed to document PT result evaluations with laboratory director (LD) signature of review for four (4) of four PT events reviewed. Findings include: 1. Review of the laboratory's PT documentation revealed the laboratory participates in American Association of Bioanalysts-Medical Laboratory Evaluation (AAB-MLE) PT as Account Number 17169 for Potassium Hydroxide (KOH) microscopy test. Review of the available PT documentation for the 4 AAB-MLE events (2025 M2, 2025 M3, 2026 M1, and 2026 M2) revealed no PT result evaluations signed by the LD for all 4 PT events. 2. When asked about a PT policy at 10:00 AM, the manager provided a Proficiency Testing policy whose procedure includes "The graded report will be reviewed immediately and submitted to the director and/or technical consultant for review." 3. In an exit interview with the manager at 11:05 AM on 9/2/26, the above findings were confirmed. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at ADOV, LLC on September 5, 2024 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: 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 laboratory's Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) logs, lack of documentation, and interview, the laboratory failed to verify twice annual accuracy of dermatology KOH microscopy testing in calendar year 2023 and up to the date of the recertification survey on September 5, 2024 for three (3) of 3 testing personnel (TP). Findings include: 1. Review of the laboratory's CMS 209 form revealed that the laboratory director identified three TP (TP #1 - #3) who performed dermatology patient KOH microscopy examinations during the twenty-two month review (November 4, 2022 to 9/5/24). *See Testing Personnel Code Sheet. 2. Review of the available split sample PT records for calendar year 2023 and year to date revealed no documentation of KOH split sample testing or proficiency records. The inspector requested to review KOH microscopy twice annual accuracy verification records for the timeframe outlined above. No documentation was available for review. 3. An interview with the clinical coordinator on 9/5/24 at 12 noon confirmed the above findings. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the laboratory's Centers for Medicare and Medicaid Services CLIA Application Form (CMS 116), procedure manual, lack of documentation, and interviews, the laboratory failed to ensure the Potassium Hydroxide (KOH) Examination of Skin, Hair, or Nails Procedure was reviewed/ approved by the new laboratory director (LD) for twenty-two (22) of 22 months after a LD change occurred on November 3, 2022. Findings include: 1. A review of the laboratory's CMS 116 form revealed patient KOH microscopy mycology examination was a provided speciality on the testing menu for the 22 month review timeframe (November 4, 2022 to 9/5/24). 2. Review of the laboratory procedure manual revealed a protocol titled: "Potassium Hydroxide (KOH) Examination of Skin, Hair, or Nails Procedure". The procedure was not signed as reviewed/approved by the current LD. The inspector noted that the procedure was incomplete and signed by the previous LD on 9/10/21. The inspector inquired regarding the missing LD approval and the missing step by step performance instructions. The clinical coordinator stated on 9/5/24 at 10:30 AM, "I will have our new director to update this procedure and to sign and date it." 3. An exit interview with the clinical coordinator on 9/5/24 at 12 noon confirmed the above findings. -- 2 of 2 --