Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(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 a review of the laboratory's preventive maintenance (PM) documentation, five (5) randomly selected patient test records, and an interview with the office manager (OM), it was determined that the laboratory failed to ensure performed tests and function checks were documented properly prior to patient testing. The findings include: 1. Based on the surveyor's review of 5 randomly selected patient test records, no