Sia Dermatology/Mohs Lab

Summary Statement of Deficiencies 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 reviews of the Slide Check-out Logs, the Proficiency Testing (PT) of MOHS Micrographic Surgery Skin Specimens procedure, and an interview with the Histology Tech, the laboratory failed to perform accuracy verification, at least twice annually. The surveyor noted the second of the two semi-annual PT events were performed and completed the following year in 2023-2024. The findings include: 1. A review of the 2023-2024 Slide Check-out Logs revealed the second 2023 PT event was not performed and completed until June 2024, and the second 2024 PT event was not performed and completed until February and April of 2025. The 2023-2024 PT schedules were as follows: A) 2023 PT Event 1, Date sent 07-30-2023, B23M-0039 and B23M-0156 cases B) 2023 PT Event 2, Date sent 06-26-2024, B23M-0174 and B23M-0885 cases C) 2024 PT Event 1, Date sent 06-25-2024, B24M-0286 and B24M- 0329 cases D) 2024 PT Event 2, Date sent 02-17-2025, B24M-0543 case E) 2024 PT Event 2, Date sent 04-08-2025, B24M-0689 case 2. A review of the Proficiency Testing (PT) of MOHS Micrographic Surgery Skin Specimens procedure revealed the following instructions. "... Semi-annually, the technician sends two cases containing the original slides out for microscopic examination by a board certified Dermatopathologist. 3. During the exit conference on 6-10-2025 at 5:15 PM, the Histology Tech confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and 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 -- other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observations during the laboratory tour, a review of the Citra Clear-Xylene Substitute (CC-XS) Instructions for Use (IFU) and an interview with the Histology Technician (HT), the laboratory utilized expired material during the Hematoxylin and Eosin (H&E) staining procedure. The surveyor noted the reagent was utilized after the expiration of 10-14-2024 to the date of the current survey, 06-10-2025. The findings include: 1. During the laboratory tour at approximately 1:27 PM, the surveyor noted expired CC-XS in the flammable cabinet, Lot number 184502 and Expiration of 10- 13-2024. The expired reagent utilized for eight months after expiration and 495 patient H&E staining procedures were performed. 2. A review of the CC-XS IFU revealed it is designed to be used for tissue processing and staining of histological and cytological specimens. During staining, CC-XS removes paraffin from tissue sections at the beginning of the staining sequence, and prepares the slide for coverslipping at the end of the staining process. 3. During an interview with the HT at approximately 1: 48 PM, she stated she did not know the reagent was expired until the surveyor informed her. The laboratory's inventory did not have any "in-date" CC-XS at the time of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of "Peer Review" records (used as Proficiency Testing [PT] for the Speciality of Histopathology), a review of the PT policy, and an interview with MOHS Tech #1, the laboratory failed to ensure the Laboratory Director documented reviews of returned results for eight of eight Peer Review activities in 2021-2022. The findings include: 1. A review of "Peer Review" records (used as Proficiency Testing for the Speciality of Histopathology) revealed the laboratory sent two cases for review to a Dermatopathologist in Atlanta, Georgia on 6/29/2021, 11/1/2021, 5/12/2022 and 12/15/2022. There was no documentation of review of the results when the forms were returned to the laboratory. 2. A review of the laboratory policy, "Proficiency Testing of MOHS Micrographic Surgery Skin Specimens" revealed the policy failed to include instructions on review of the results upon return from the Dermatopathologist. 3. During an interview with on 3/23/2023 at 10:23 AM, the surveyor asked if the Laboratory Director (LD) documented a review of the Dermatopathologist's findings when the Peer Review records when were returned; MOHS Tech #1 stated the LD looked at the results, but there was no place on the form for her to sign. The surveyor explained the laboratory was required to document a review of the returned PT results and implement