Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the DermASAP/ID of Quincy laboratory on 07/02/2026 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 and interview with the Mohs Manager (MM) and the Histotechnician on 07/02/2026, the laboratory failed to define and correctly document temperature conditions for the proper operation of the Advantik Cryostat as evidenced by the following: The surveyor reviewed the laboratory's Hematoxylin and Eosin Staining Maintenance Logs which contain the Cryostat recorded temperature records for calendar years 2025 and 2026. The acceptable temperature range for the Cryostat listed on the logs is -24 to -30 degrees Celsius. The review revealed that the recorded temperatures from May 2025 to October 2025 were out of range for 22 of 25 days when the Cryostat was in use for Mohs testing. The recorded temperatures were in range for all days when the Cryostat was in use for Mohs testing from January 2025 to April 2025 and from November 2025 to June 2026. The MM and the Histotechnician confirmed in an interview on 07/02/2026 at 9:22 A.M. that the recorded temperatures of the Cryostat from May 2025 through October 2025 were out of range for 22 of 25 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 -- days when the Cryostat was in use for Mohs testing. The laboratory performs 300 Histopathology Mohs slide examinations annually. -- 2 of 2 --