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 observations made during a tour of the laboratory, lack of documentation, as well as interviews with staff, it was determined the laboratory failed to perform function checks as defined by the laboratory. As evidenced by: A. During a tour of the laboratory on 01/11/2019 at 0900, the laboratory centrifuge was observed with no documentation of centrifuge speed checks. B. The surveyor requested documentation of centrifuge speed checks but none were provided. C. In an interview on 1/11/2018 at 0930, laboratory employee #1 (as listed on the form CMS-209) stated that the centrifuge speed has not been checked in two years. 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 --