Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 20, 2018. Dermatology Advanced Care clinical laboratory had one deficiency found at the time of the visit. 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 and interview, it was determined that the laboratory did not document room temperature and humidity requirements to assure optimal operating conditions and temperatures of the Cryostat ( Leica ) equipment each day of patient testing in accordance with CLIA requirements for the whole time that the laboratory was set up. Findings included: Review of the equipment's manufacturer procedure indicated that the Cryostat ( Leica ) requires a storage maintenance of a room temperature range at a maximun relative humidity of 60 %. There was no room temperature and humidity log available for documenting the temperature of the laboratory room for 2 years from 2017-2018. Interview on 7/20/18 at 12:30 PM, testing person # 2 confirmed that the temperature and humidity of the laboratory room were not checked and documented daily. 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 --