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: A. Based on lack of documentation and interview with the Mohs Histotechnician (MH), the laboratory failed to perform and document scheduled preventive maintenance as defined by the manufacturer for 1 of 1 Linistain Automatic Slide Stainer used to perform dermatopathology microscopic examinations from 03/08/2024 to 03/09/2026. Findings include: 1. The Linistain Automatic Slide Stainer Owner's Manual, Preventative Maintenance procedure stated, "Periodic Maintenance: This part of the maintenance section contains information that extends the life of the stainer and assures that it is ready for use when needed. Case Cleaning, Internal Cleaning, Cleaning/Disinfecting Staining Jars and Evaporation Covers." 2. On the day of the survey, 03/09/2026 at 2:24 pm, the laboratory failed to provide documentation for preventive maintenance (as defined by the manufacturer) performed on 1 of 1 Linistain Automatic Slide Stainer used to stain dermatopathology microscopic examinations from 03/08/2024 to 03/09/2026. 3. The laboratory performed 1500 dermatopathology microscopic examinations in 2025 (CMS 116, estimated annual volume, dated 2/27/2026). 4. The MH confirmed the above findings on 03/09/2026 at 3:15 pm. B. Based on observation of the laboratory, lack of documentation, and interview with the Mohs Histotechnician (MH), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 Traceable thermometers used for monitoring room temperatures and relative humidity in the laboratory from 07/22/2025 to 03/09/2026. Findings include: 1. On the day of the survey, 03/09/2026 at 2:24 pm, observation of the laboratory revealed the following thermometer used to monitor room temperatures and relative humidity for dermatopathology testing was past due for calibration: - Traceable room 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 -- temperature and humidity monitor, s/n 230488046, calibration expiration date 07/21 /2025. 2. The laboratory failed to provide maintenance and function check records for 1 of 1 Traceable thermometers from 07/22/2025 to 03/09/2026. 3. The MH confirmed the above findings on 03/09/2026 at 3:15 pm. -- 2 of 2 --