Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 3, 2021. Dermatology Associates of Tallahassee DBA Dermatology Southeast of Panama City was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 staff interview, the laboratory failed to document laboratory humidity for two of two years reviewed (April 2019- March 2021). The findings include: Review of maintenance records found no humidity documented. During an interview on 3/3/21 at 10:05 AM the MOHs technician confirmed that there was no humidity recorded. 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 --