Advanced Dermatology Of Michigan

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to follow their procedure for recording the cryostat temperature and/or maintenance each day of use for 22 out of 25 months reviewed. Findings: 1. Procedure "Quality Control Maintenance" states under section "B. Cryostat Temperature" that "1. The temperature of the cryostat must be recorded and initialed each day of use." Under section "C. Cryostat Maintenance Record." the procedure states "1. The cryostat must be cleaned after each use and the initials of the histologist recorded of the appropriate date." 2. Review of the patient log determine patient testing was performed 03/17/2021 and 03 /18/2021. 3. Review of the "Cryostat Temperature Log" for March 2021 revealed no temperature documented on 03/17/2021 and 03/18/2021. 4. Review of "Monthly Quality Assurance Checklist" for March 2021 indicated "YES" for "All required temperatures were recorded." 5. No records of cryostat maintenance were found for January - August 2021, February 2020, and April - December 2020 when patient testing was performed. 6. No records of cryostat temperatures were found for August - November 2019 when patient testing was performed. 7. Testing personnel (TP#1) stated during phone interview on August 19, 2021 at approximately 12:55 PM that the cryostat maintenance and temperatures were located in the binder. 8. The records were not found during the survey. 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 observation, record review, and interview with the mohs technician, the laboratory failed to document cryostat operating temperatures for 2 (December 2017 to December 2019) of 2 years. Findings include: 1. An observation on 12/5/19 at 8:05 am by the surveyor revealed the laboratory had a Leica CM 1850 cryostat in use. 2. A review of the laboratory's established "General Laboratory Quality Assurance" policy revealed a section stating, "Temperatures are taken and recorded in the Histology Laboratory each day of operation. Cryostat, refrigerator, freezer and room temperature are taken in the morning and recorded on the appropriate temperature recording form." 3. A review of laboratory temperature records revealed a lack of recorded cryostat operating temperatures. 4. An interview on 12/5/19 at 9:15 am with the mohs technician confirmed the laboratory had not been recording cryostat operating temperatures. 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 --