Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Dermatology of Virginia on March 23, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on a review of policies, patient test logs, histology slides, Mohs surgery map records, and interviews, the laboratory failed to follow their written policy for labeling patient Mohs slides for twelve (12) of eighteen (18) random Mohs case numbers reviewed on the date of the inspection, March 23, 2023. Findings include: 1. Review of the policy manual revealed a procedure for labeling and accessioning of patient Mohs slides (section 4.4, title: Specimen Handling, Storage, Transport, and Identification) that stated, "patient tissue samples are assigned and labeled with unique mohs identification number and patient name, date of surgery, tumor location, number of stages/slides" (approved by the Director and Clinical Consultant Histopathologist 06/25/19). 2. During a review of patient histopathology Mohs test logs (timeframe of May 2021 to the date of the inspection on 3/23/23) the inspector requested to review histology slides, surgical maps, and results for the following 18 random case numbers and dates of surgery: M21-236 through M21-240 done on 12/21 /21 (5 cases); M22-047 done on 03/15/22 (1 case); M22-071 through M22-080 done on 05/02/22 (10 cases); M22-191 done on 11/01/22 (1 case); M23-031 done on 02/21 /23 (1 case); The inspector noted for case M21-238 the mapping and patient log was 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 -- denoted as performed on 12/21/21 while four (4) of 4 slides were labeled with a date 12/20/21. The inspector noted that 70 of 70 slides for cases M21-236, M21-237, M21- 239, M21-240, M22-047, M22-071 through M22-080 had no date of surgery denoted. 3. The inspector inquired of the lead histotech to outline the protocols followed for labeling tissue samples. The histotech stated on 3/23/23 at approximately 11:30 AM, "We label with case number, patient name, and date of surgery, and lesion numbers. A previous histo tech did not always put dates on the slides. We are currently putting the dates on the slides per the procedure." 4. An interview with the staff histo tech and practice manager on 3/23/23 at approximately 12:30 PM confirmed the above findings. -- 2 of 2 --