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: Through a review of Cryostat Maintenance Records and Laboratory Temperature Logs for 2017 through the date of the survey, and through an interview with laboratory staff, it was determined the laboratory failed to document that Cryostat #1 and Cryostat #2 temperatures were within the established limits for acceptable functioning for frozen section histopathology. Survey findings include: A. In a review of Laboratory Temperature Logs for 2017 through the date of the suvey it was determined the laboratory did not document cryostat temperature for each cryostat on the days of testing (32 of 32 days) although two cryostats (#1 and #2) were in use each day of testing, as documented on the Cryostat Maintenance Records. B. In an interview at 10:07 on 9/20/2019, laboratory employee #2 (as listed on the Laboratory Personnel Identification Worksheet) confirmed the laboratory documented one cryostat temperature each day of testing although two cryostats were in use each day. 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 --