Summary:
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 Quality Control (QC) Mohs Micrographic Surgery Peer Review (MSPR) records, the Proficiency Testing (PT) Policy and Procedure (P&P) manual, and an interview with the Laboratory Director (LD) and Mohs Technician, the laboratory failed to completely document PT accuracy verification, at least bi- annually. The surveyor noted three of the eight PT events reviewed were missing documentation of the peer review from the pathologist and the final accuracy verification review of the LD from 2023-2024. The findings include: 1. A review of the 2023-2024 QC Mohs MSPR records revealed the pathologist performing the Peer Review had no documentation of assessments for the following events. A) 2023 PT 2, 3 cases B) 2024 PT 1, 3 cases C) 2024 PT 2, 3 cases 2. A review of the "Quality Control for Mohs Micrographic" log sheets revealed the Mohs Tech completed the "Date", "Patient Name", "Mohs Number", and "Site" for three patients biannually. The surveyor noted the Mohs Tech also included the Mohs Surgeon's diagnosis with the "Site" information. The case slides and the sheet are sent to a second MOHS surgeon for "Peer Review". 3. A review of the "Quality Control for Mohs Micrographic" Bi-annual Event 2023 #2 sheet revealed the Peer Reviewer failed to document his assessment of the "Stain Technique"," Adequate Specimen Preparation" and the "Diagnostic Interpretation". The second Mohs surgeon only signed and dated the bottom of the form. There was no evidence of the Laboratory Director's review of the returned results to determine completeness or whether there were discrepancies in the any of the cases. 4. A review of the "Quality Control for Mohs Micrographic" Bi- annual Events 2024 #1 and 2024 #2 sheets revealed the same second Mohs surgeon again failed to document his assessment and only signed and dated the bottom of the 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 -- form. The LD also signed and dated the returned sheet however the surveyor saw no documentation of a review by the LD to determine completeness whether there were discrepancies in any of the cases. 5. A review of the PT P&P for Mohs Micrographic Surgery cases revealed the following instruction was not followed by the laboratory based on the incomplete documentation of assessments and final review. ..."Three cases will be sent internally or externally to another Mohs surgeon to be evaluated for any inconsistencies in the quality and interpretation." ..."Upon receipt of the pathology report from the Pathologist/Mohs surgeon diagnosis of the slide specimen will be match to the in-house diagnosis by the physician." 6. During the exit conference on 6-25-2025 at 12:15 PM, the LD and the Mohs Technician 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 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 a review of the Quality Control (QC) MOHS Tissue Staining Procedure logs and an interview with the Laboratory Director (LD) and MOHS Technician, the laboratory utilized expired reagents for patient testing. The surveyor noted one of the four reagents used for the tissue staining procedure was utilized after expiration from 01-02-2024 through 07-17-2024. The findings include: 1. A review of the QC MOHS Tissue Staining Procedure logs revealed the Xylene Substitute Lot 142044 expired on 08-26-2023, and was utilized for 45 days after expiration; 1160 patient specimen were stained using the expired reagent. 2. During the exit conference on 06-25-2025 at 12: 15 PM, the LD and MOHS Technician confirmed the above findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the Laboratory Director (LD) and MOHS Technician, the LD failed to ensure documentation of the annual competency assessments for Testing Personnel (TP) responsible for the Provider Performed Microscopy (PPM). The surveyor noted five of the eleven TP had no documentation of competency assessment from the date of the last survey, 03-01- 2023 to the date of the current survey, 06-25-2025. The findings include: 1. A review of personnel records for TP listed on the CMS-209 Form (Laboratory Personnel Report) who performed PPM revealed the LD failed to document the annual competency assessments for TP3, TP4, TP7, TP9 and TP10 from 2023-2025. 2. During the exit conference on 06-25-2025 at 12:15 PM, the LD and MOHS Tech confirmed the above findings. -- 2 of 2 --