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 Bi-Annual Peer Review (PR) Accuracy Verification (AV) records, the Policy and Procedure manual, and an interview with the Supervisor and the MOHS Technician, the laboratory failed to ensure the Laboratory Director (LD) documented final reviews of the bi-annual PR AV. The surveyor noted 15 of the 15 PR AV from 2025-2026 were missing final reviews from the LD when UAB Dermatopathology results were returned. This is a repeat deficiency. The findings include: 1. A review of the Bi-Annual PR AV records revealed no documentation of the LD's final reviews of the returned UAB Dermatopathology results. 2. A review of the Policy and Procedure manual revealed "... three cases... every six months...sent to UAB Dermatopathology...final review by the LD". 3. The Supervisor and the MOHS Technician confirmed the above findings during the exit conference on 05-21-2026 at 12:49 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Cryostat maintenance records, the Cryostat Leica CM 1860 and 1520 operator's manuals, and an interview with Supervisor and the MOHS 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 -- Technician, the laboratory failed to document Cryostat weekly maintenance as per manufacturer's instructions. The surveyor noted there was no documentation of the weekly maintenance for 24 of the 24 months reviewed from May 2024 through April 2026. The findings include: 1. A review of the Cryostat maintenance records revealed no documentation of the required weekly maintenance for 24 months from 2024-2026. 2. A review of the Cryostat Leica CM 1860 (page 71) and 1520 (page 69) operator's manuals revealed the following weekly maintenance instructions. A) "Lubricate the plastic coupling..." B) "Lubricate the specimen cylinder..." 3. The Supervisor and MOHS Technician confirmed the above findings during the exit conference on 05-21- 2026 at 12:49 PM. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on reviews of the daily Slide Quality Assurance (QA) records, patient testing logs and an interview with the Supervisor and the MOHS Technician, the laboratory failed to ensure review of the slide Quality Control (QC) was performed and documented each day of patient testing. The surveyor noted there was no documentation of the slide QC for 11 of the 14 testing days in December 2024. The findings include: 1. A review of the daily Slide QA records revealed the laboratory failed to document the 2024 slide QC for the following days prior to patient testing, December 5, 9-13, 16-20. 2. A review of the patient testing logs revealed 82 patients were performed when the slide QC was not documented. 3. The Supervisor and MOHS Technician confirmed the above findings during the exit conference on 05-21- 2026 at 12:49 PM. -- 2 of 2 --