Summary:
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 review of temperature charts and interview, the laboratory failed to document the cryostat temperature each day of use for Mohs testing. Findings follow. Review of the temperature charts from Feb 2018 to Feb 24, 2021 showed the cryostat temperature was only recorded once per week. In Jan 2021, the temperatures were recorded on Jan 8, 15, 22, and 29. Interview with the laboratory director confirmed on February 24, 2021 at 1515 hours in the break room that Mohs was performed Monday thru Thursday. Interview with the histotechnologist on February 24, 2021 at 1520 hours confirmed he was only recording temperatures and maintenance on the cryostat once per week. 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 2 -- This STANDARD is not met as evidenced by: Based on review of the maintenance log and interview, the laboratory failed to document maintenance procedures for the Cryostat used for preparing frozen tissue specimens for Mohs testing. Findings follow. Review of the maintenance logs from Feb 2018 to Feb 24, 2021 showed the cryostat maintenance was only recorded once per week. In Jan 2021, the maintenance was recorded on Jan 8, 15, 22, and 29. Maintenance included: 1. Clean interior, 2. Moving components 3. Clean air filter, 4. Preventative maintenance, 5. Defrost of machine. Interview with the laboratory director confirmed on February 24, 2021 at 1515 hours in the break room that Mohs was performed Monday thru Thursday. Interview with the histotechnologist on February 24, 2021 at 1520 hours confirmed he did not document maintenance procedures each day of use. -- 2 of 2 --