St Luke's Clinic Dermatology & Mohs Surgery

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 lack of documentation and an interview with the practice manager on 6/16 /2023, the laboratory failed to document, at least twice annually, the verification of accuracy for potassium hydroxide (KOH) examinations in 2022 and 2023. The findings include: 1. A lack of documentation for bi-annual verification identified that the laboratory failed to document verification of accuracy for KOH examinations at least twice annually in 2022 and 2023. 2. An interview with the practice manager on 6 /16/2023 at 10:21 am confirmed that the laboratory has not performed bi-annual verification of KOH examinations. 3. The laboratory reports performing 3 KOH examinations annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory compliance officer on 12/2/2021, the laboratory failed to document humidity as required for operation of the Leica cryostats while performing Mohs procedures. The findings include: 1. A review of the manuals for the Leica CM1520 and CM1950 cryostats identified that the operational humidity is less than 60%. 2. A review of the laboratories daily QC log identified that the laboratory failed to document humidity. 3. An interview with the laboratory compliance officer confirmed that the laboratory fail to document humidity. 4. The laboratory reports performing 1,000 Mohs procedures annually. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory compliance officer on 12/2 /2021, the laboratory failed to perform maintenance on the Leica CM1520 cryostat as defined by the manufacturer and with at least the minimum specified frequency. The findings include: 1. The Leica CM1520 cryostat manual states that the instrument must have the plastic coupling oiled and the specimen cylinder lubricated weekly. 2. A record review of the daily QC log identified that the laboratory failed to document weekly maintenance required by the manufacturer on the Leica cryostat CM1520. 3. An interview with the laboratory compliance officer on 12/2/2021 at 1:30 pm confirmed that the laboratory had not document performance of weekly maintenance on the Leica cryostat CM1520. 4. The laboratory reports performing 1000 Mohs procedures annually. D5781