Summary:
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 room temperature records from November 29, 2022 through December 10, 2024 and interview with the facility personnel, the laboratory failed to monitor and document the room temperature where dermatopathology reagents are utilized and stored on each day of patient testing. Findings include: 1. The laboratory processes specimens and interprets dermatopathology slides in conjunction with Mohs surgery and Frozen Biopsies, with an approximate annual test volume of 1,656. The laboratory performs testing on 2 days per month. 2. The laboratory failed to monitor and document the temperature of the room where dermatopathology reagents are utilized and stored each day of testing on approximately 50 out of 50 testing dates between November 29, 2022 through December 10, 2024. 3. The facility personnel interviewed on 12/10/24 at 12:50 PM confirmed that the laboratory failed to monitor and document the room temperature of the laboratory from November 29, 2022 through December 10, 2024. 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 --