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 observation, record review and interview with the Office Manager (OM), the laboratory failed to establish a preventative maintenance protocol for a thermometer for 19 (November 2023 to July 2025) of 19 months reviewed. Findings include: 1. During a laboratory tour on 06/30/2025 at 9:30 a.m., the surveyor observed a ThermPro thermometer in use. The thermometer lacked documentation of a calibration or maintenance date. 2. Review of laboratory procedures revealed the absence of a written policy addressing preventive maintenance or calibration of thermometers. 3. During an interview on 06/30/2025 at 10:00 a.m., the OM confirmed that the thermometer was used for monitoring ambient room temperature and no annual maintenance or calibration had been performed on the thermometer. 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 --