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 a review of the Bi-Annual Quality Control (QC) Peer Review (PR) Proficiency Testing (PT) records, the Policy and Procedure Manual and an interview with the Office Manager (OM), the laboratory failed to document one of the one accuracy verification reviews due in 2025 and was missing two of the three cases due in the first half of 2026, as per laboratory policy. The findings include: 1. A review of the 2025 Bi-Annual QC PR PT records revealed no documentation of MOHS surgery accuracy verification the first six months of the year and only one case was submitted for the first half of 2026. 2. A review of the PT Procedure revealed twice per year the laboratory will submit 3 cases to DermPath Lab for accuracy verification of the MOHS surgeon's diagnosis. 3. The OM confirmed the above findings during the exit conference on 08-11-2026 at 2:30 PM. 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 direct observations, review of the 2026 Chemical Log Sheet and an interview with the Office Manager (OM), the laboratory utilized one of the staining 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 -- reagents after expiry for patient testing for seven of the seven months reviewed in 2026. The findings include: 1. During the laboratory tour with the OM, at approximately 09:49 AM, the surveyor observed the Eosin Solution, Lot 2325644 had expired on 09-18-2025. 2. A review of the 2026 Chemical Log Sheet showed the above reagent was used for patient testing from January-July 2026. 3. The OM confirmed the above findings during the exit conference on 08-11-2026 at 2:30 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 review of the Cryostat maintenance logs, and an interview with the Office Manager (OM), the laboratory failed to document Cryostat weekly and monthly maintenances as indicated on the maintenance log form. The surveyor noted 17 of the 17 months reviewed in 2024-2026 had no documentation of the weekly and monthly maintenances. The findings include: 1. A review of the Avantik QS 12 Cryostat maintenance logs showed no documentation of the required weekly and monthly maintenances for seven months in 2024, three months in 2025 and seven months in 2026. 3. A review of the patient history records revealed 190 patients were performed when the weekly and monthly maintenances were not documented. 4.The OM confirmed the above findings during the exit conference on 08-11-2026 at 2:30 PM. -- 2 of 2 --