Wasatch Dermatology

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 record review, direct observation, and interview with testing personnel #1 (TP1), room temperature and humidity of the laboratory was not monitored. The laboratory performs approximately 3,500 tests annually. Findings include: 1. Record review of maintenance logs did not include recorded room temperature and humidity. There was no written policy for the monitoring room temperature or room humidity. 2. No thermometer or hygrometer was present in the laboratory during observation on 07/07/2022 at approximately 13:30. 3. The Leica CM1510 Cryostat requires an operating environment of less than 22C and relative humidity must not exceed 60%. 4. In an interview on 07/07/2022 at approximately 14:15, the testing personnel #1 confirmed room temperature and humidity was not monitored or recorded. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper 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 -- use. This STANDARD is not met as evidenced by: Based on direct observation, record review, and staff interview with testing personnel #1, the laboratory failed to write open and expiration dates on 7 of 7 bottles of dye used for inking tissue for Mohs histopathology slides. The laboratory performs approximately 500 Mohs histopathology slides per year. Findings include: 1. During laboratory tour on 07/07/2022, laboratory failed to have open and expiration dates written on 7 of 7 tissue marking dyes. 2. In an interview on 07/07/2022 at approximately 14:15, testing personnel #1 stated that they do not write open and expiration dates on reagents when they are being put into use. 3. During record review of the laboratory's standard operating procedure (SOP) manual on 07/07/2022, the laboratory failed to include instructions to document preparation and expiration dates on dye when it is put into use. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to retain documentation of reagent lot numbers, expiration dates, and record the dates reagents were placed in use for Hematoxylin and Eosin (H&E) staining of Mohs surgery tissue slides for 5 of 5 months of testing reviewed. The laboratory began patient testing in 09/2017 and had performed approximately 277 Mohs surgeries. Findings include: 1. The laboratory failed to retain records of each reagent lot number, dates reagents were in use, and reagent expiration dates for H&E reagents used to stain histopathology tissue slides. 2. Staff stated they had used multiple lot number of reagents since they began testing in 09/2018 and did not document which lots were in use and when they replaced their working reagents. 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 --