Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policies and procedures, preventive maintenance (PM) documentation, ten (10) randomly selected Mohs patient test records, and an interview with the department administrator (DA), it was determined that the laboratory failed to ensure preventive maintenance performed was monitored and documented properly prior to patient testing. The findings include: 1. Based on the review of the PM documentation called "Microscope, Hematoxylin and Eosin (H&E) Stain Quality Control Log" on December 12, 2024, at approximately 3:30 p. m., no check mark or initial was found recorded on April 25, 2024. 2. Out of 10 patient records reviewed by the surveyor on December 12, 2024, at approximately 3: 30 p.m., the surgery for patient M24-0283 was performed on 4/25/24 during the time when PM entry was missed to be recorded. Thus, the quality of the control slide created that day cannot be assured. 3. Based on the laboratory's policy and procedure for quality assessment, it was the practice of the laboratory that log sheets are reviewed on a timely manner. The log sheet for April 2024 was reviewed and signed on December 11, 2024. However, no