Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Derm One PLLC on 03/08/23 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 the review of policy and procedures (P&P), peer review records, lack of documentation and interview, the proficiency testing (PT) peer review reports failed to include date of review by reference pathologist, and name and address of both referring and reference laboratory for six of six reports reviewed, and diagnosis of specimen by reference pathologist for four of the six reviewed at the date of survey on 03/08/23. Findings include: 1. Review of the P&P revealed the policy "Proficiency Testing Mohs Micrographic Surgery Skin Specimens" that stated, "Semi-annually, the tech or risk manager will send pathology, the original slides, the surgical case number, and send it for a microscopic examination by a board-certified dermatopathologist. No differential diagnosis will be offered with the specimen." 2. In an interview with testing personnel (TP) A on 03/08/23 at approximately 09:40 AM, they stated, "We were bought out by a new company in Florida in 8/2020. The company instructed us to send all peer reviews to them. We have had difficulty receiving results." 3. Review of six PT peer review records revealed lack of documentation as follows: 21M-26818 and 21M-26959- lacked date of review by reference pathologist and name/address of both referring and reference laboratory, 21M-26825- lacked date of review by reference pathologist, diagnosis of specimen by reference pathologist, and name /address of both referring and reference laboratory. 22M-27828, 22M27939, and 22M- 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 -- 28025- date of review by reference pathologist, diagnosis of specimen by reference pathologist, and name/address of both referring and reference laboratory. 4. An exit interview with TP A on 03/08/23 at approximately 10:45 AM confirmed the findings. -- 2 of 2 --