Summary:
Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on the surveyors' review of the laboratory's equipment and preventive maintenance (PM) policy and procedure, ten patient test records for Provider Performed Microscopy (PPM), preventive maintenance documentation, and an interview with the office manager (OM) on May 11, 2026, it was determined that the laboratory failed to follow an established protocol for the microscope preventive maintenance prior to patient testing. The findings include: 1. The laboratory's equipment and preventive maintenance policy and procedure stated that the microscope PM was performed prior to patient testing. 2. One out of ten records had a missing entry on May 7, 2026, for the microscope daily PM. 3. The OM confirmed by an interview on May 11, 2026, at approximately 3:00 p.m. that the laboratory failed to follow their established protocol to perform the daily PM and document it in the log prior to patient testing and no