Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory did not document the expiration date of reagents, stains used to stain and ink tissue for histopathology. Findings: 1. The laboratory reagent receipt and use log did not include the expiration date of reagents and stains; and 2. This was confirmed with staff during the exit with the laboratory staff at noon on the day of survey. 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 review of the cryostat daily preventive maintenance record and interview with laboratory staff, the laboratory did not document the temperature of the cryostat each day of use. Findings: 1. The preventive maintenance record did not include the daily temperature of the cryostat each day of use; and 2. This was confirmed with staff during the exit with the laboratory staff at noon on the day of survey. 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 --