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 direct observation of the laboratory testing room and an interview with the Laboratory Director (LD), the laboratory failed to use a non-expired thermometer hygrometer. Findings include: 1. During a laboratory tour on 5/16/2024 at 12:00 pm at the laboratory testing room revealed that the Fisherbrand thermometer hygrometer lot: S/N 22L509985 monitor expired as of 05/10/2024. 2. Direct observation on 5/16/2024 at 12:01 pm the laboratory revealed the new thermometer hygrometer in a drawer in a box unopened. 2. An interview with the LD confirmed on 05/16/2024 at 12:00 pm that the laboratory did not put the non-expired thermometer hygrometer monitor in use. 3. The laboratory reports performing 1,841 tests annually. 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 --