Advanced Dermatology And Cosmetic Surgery

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/23/2024 found the ADVANCED DERMATOLOGY AND COSMETIC SURGERY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for 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 recorded a Cryostat temperature outside of the acceptable range in one out of two testing days during August 2023 and tested patients. Findings included: 1- Review of "CRYOSTAT TEMPERATURE LOG" form, revealed that stated: "Action should be taken and documented if temperature is outside required range. Normal Ranges are -18C to -27 C." 2- Review of "CRYOSTAT TEMPERATURE LOG" for 19 consecutive months from February of 2023 until August of 2024 revealed that on the Month of August 2023, there was two testing dates: August 15th and August 29. The temperature recorded for August 29th was "-10C", which was outside of the acceptable range. That day the laboratory tested 14 patients. No

Summary Statement of Deficiencies D0000 An intial survey conducted on 1/24/2023 found the ADVANCED DERMATOLOGY AND COSMETIC SURGERY clinical laboratory not in compliance with 42 CFR Part 493, Requirements for 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 observation, record review and interview, the laboratory failed to monitor and document the laboratory temperature and humidity during at least the past two years. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 observation, record review and interview, the laboratory failed to have annual maintenance performed on the microscope, or documentation showing that annual maintenance was performed during the year 2021. -- 2 of 2 --