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 review of six patient testing records dated 10/18/2026 to 1/23/2026, review of preventive maintenance (PM) documentation, surveyor observations during the laboratory tour, and an interview with the manager on August 13, 2026, the laboratory failed to establish and maintain a written equipment maintenance policy and procedure for the microscope and failed to document preventive maintenance to ensure proper functioning of test systems prior to patient testing. The findings include: 1. The laboratory failed to provide an established and approved equipment policy and procedure for the microscope used for patient testing. 2. During review of six patient test records dated 10/18/2026 to 1/23/2026, the manager was unable to provide preventive maintenance documentation for the Labomed CxL (microscope #3, equipment #46080) used for patient testing. 3. During the laboratory tour on August 13, 2026, the surveyor observed two microscopes: a. Microscope #1: Labomed CxL, microscope #3, equipment #46080. b. Microscope #2: Labomed CxL with a service sticker from WesCo dated 11/2020. The manager stated that this microscope was not used for histopathology slide review. 4. During an interview on August 13, 2026 at approximately 12:00 p.m., the manager confirmed that the laboratory was unable to provide any preventive maintenance documentation for the microscope and did not have a written maintenance policy. 5. According to the testing declaration form submitted at the time of the survey, the laboratory performed approximately 500 cases Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- annually, including during the time when the PM policy was unavailable and documentation for the years 2024, 2025, and 2026 was missing and could not be verified. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on the lack of equipment maintenance policy and procedure, lack of preventive maintenance records for the microscope used for patient testing, review of six patient records, and interview with the manager on August 13, 2026, the laboratory director failure to ensure that required policies, procedures, and maintenance systems for equipment used in patient testing were established, approved, implemented, and monitored. See D5433. -- 2 of 2 --