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 review of the Leica CM 1860 Cryostat instructions for use, review of Leica CM 1860 cryostat maintenance records and interview with the executive director, the laboratory failed to perform and document maintenance as defined by the manufacturer for the Leica CM 1860 Cryostat in 2025 and to date February 24, 2026. Findings: 1. Review of the Leica CM 1860 Cryostat instructions for use states, "At least once a year, have the instrument inspected by a qualified service engineer authorized by Leica". 2. Review of the Leica CM 1860 Cryostat maintenance records showed no documentation of an instrument inspection performed in 2025 and to date February 24, 2026. 3. Interview with the executive director on February 24, 2026 at 11:00 AM confirmed, the laboratory failed to perform and document maintenance as defined by the manufacturer for the Leica CM 1860 Cryostat in 2025 and to date February 24, 2026. 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 --