Omni Dermatology, Inc

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 lack of humidity records for review from 2022, 2023 and 2024, review of the manufacturer's specifications for the Leica CM1510 Cryostat and interview with the facility personnel, the laboratory failed to monitor and document the ambient humidity of the room where the cryostat is utilized. Findings include: 1. The laboratory utilizes the Leica CM1510 Cryostat in conjunction with Mohs testing under the subspecialty of Histopathology, with a reported annual test volume of 540. 2. The manufacturer's specifications for the Leica CM1510 Cryostat reviewed during the survey listed an operating relative humidity range of 0%-60%. 3. On the survey date of 7/24/2024, the laboratory failed to provide documention demonstrating the ambient humidity of the room where the cryostat is utilized was monitored and recorded on each day of patient testing during 2022, 2023 and 2024 (through the date of the survey). 4. The facility personnel interviewed on 7/24/2024 at 9:00 AM confirmed the laboratory failed to monitor and document the ambient humidity as indicated above. 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 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance policy and interview with the facility personnel, the laboratory failed to indicate the frequency of preventative maintenance of the microscope used in Dermatopathology patient testing. Findings include: 1. The laboratory did not indicate in the microscope procedure policy how often the microscope is undergo preventative maintenance procedures. 2. According to a company sticker on the microscope, an outside company did perform preventative maintenance on the microscope in August 2016 and the microscope was due in August 2017 for preventative maintenance. 3. The facility personnel acknowledged that the maintenance procedures indicated above failed to include specific information regarding the frequency of preventative maintenance activities and that the microscope was not serviced for preventative maintenance in 2017. 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 --