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Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 observation of the laboratory, lack of documentation, and interview with the Regional Clinic Manager (RCM), the laboratory failed to perform and document the maintenance/ function checks for 2 of 2 microscopes used for histopathology, mycology, and parasitology microscopic examinations performed in 2023. Findings Include: 1. Step #8 of the laboratory's policy "M-721-E-ii Microscope Quality Control Policies and Documentation" states " Microscope maintenance annually." 2. On the day of survey, 03/05/2024 at 01:38 pm, the laboratory failed to provide the maintenance/function check records for the following 2 of 2 microscopes used for histopathology, mycology, and parasitology microscopic examinations performed in 2023: - Olympus BX46 Manufacturer #2B47592. - Olympus LHB Manufacturer #428974. 3. The laboratory reported an annual volume of 657 in histopathology, and 238 in microbiology. (CMS 116) 4. The above findings were confirmed by the RCM on 03/05/2024 at 1:38 pm. 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 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of quality control (QC) records and interview with the Team Lead, the laboratory failed to include a negative and positive control material each day of patient testing for Potassium Hydroxide (KOH) and Wet Mount microscopic examinations from 08/03/2020 to the day of survey. Findings include: 1. On the day of survey, 08/03/2022 at 12:44 pm, the laboratory could not provide documentation of daily QC performed for mycology (KOH) and parasitolgy (Wet Mount) microscopic examinations from 08/03/2020 to 08/03/2022. 2. The laboratory performed 375 parasitology and mycology examinations in 2021. 3. The Team Lead confirmed the finding above on 08/03/2022 around 01:25 pm. 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 --