Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, preventive maintenance (PM) logs and an interview with the regional director (RD), the laboratory failed to perform and document the equipment maintenance as defined by the manufacturer with at least the frequency specified. The findings include: 1. The laboratory's policy mandates that PM for the microscope will be conducted at least every six months. However, the review of records showed that PM was only performed annually by Western Scientific Co. (WesCo) and was missed in 2023. 2. During an interview on March 20, 2025, at approximately 9:35 a.m., the RD affirmed that the annual PM for the microscope was missed for 2023, as mentioned in statement.#1. 3. According to the testing volume declaration submitted at the time of survey, the laboratory performed and reported approximately 121 tests annually for Mycology, Parasitology and Histopathology during the time that annual equipment PM calibration was missed to be performed and documented. 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 --