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 observation of the laboratory, lack of documentation, and interview with the Practice manager (PM), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 Fisher Brand Traceable thermometer/humidity monitor used for monitoring room temperature and humidity in the histopathology laboratory from 04/25/2023 to the day of the survey. Findings include: 1. On the day of the survey, 04/23/2025 at 09:45 am, observation of the laboratory revealed the following thermometer used for room temperature and humidity monitoring in the histopathology laboratory was due for maintenance: - 1 of 1 Fisher Traceable Thermometer (S/N 181386930) due 06/2022. 2. The laboratory failed to provide maintenance/functions checks records for the Fisher Brand Traceable thermometer/humidity monitor from 04/25/2023 to 04/23 /2025. 3. The laboratory performed 3155 histopathology examinations in 2024 (CMS 116, estimated annual volume). 4. The PM confirmed the findings above on 04/23 /2025 at 09:45 am. 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 --