Ronald M Mann, Md, Pc Dba Catalina Dermatology

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 2021, 2022 and 2023, review of the manufacturer's specifications for the cryostat, and interview with the facility personnel, the laboratory failed to monitor and document the humidity of the area where the cryostat is utilized. Findings include: 1. The laboratory utilizes the Leica CM1860 Cryostat to process patient samples for Mohs testing. The laboratory's reported annual test volume in the subspecialty of Histopathology is 1,100. 2. The manufacturer's specifications for the Leica CM1860 Cryostat reviewed during the survey listed an operating relative humidity range of 20% - 60%. 3. On the survey date of 11/08/2023, no documentation was provided to indicate the laboratory monitored and documented the humidity of the room where the cryostat is utilized for each day of patient testing during 2021, 2022 and 2023, through the date of the survey. 4. The facility personnel interviewed on November 8, 2023 at 12:00 PM confirmed the laboratory failed to monitor and document the 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, the microscope maintenance log and interview with the facility personnel, the laboratory failed to document the routine maintenance of the microscope used in patient testing under the sub-specialty of Dermatopathology. Findings include: 1. There were no entries on the log sheet after 10/17/2016 for the routine maintenance of the microscope that includes the cleaning of the stage and oculars every Monday per laboratory policy. 2. The facility personnel acknowledged that the logs indicated above were missing. 3. The laboratory's annual test volume is 1100. 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 --