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 lab staff, the lab did not ensure that substandard culture media was not used for testing. Findings: 1. The lab did not record the date the culture media was received on media quality control records for April 2018; 2. The lab did not document the media characteristics upon receipt on media quality control records for January 2018; and 3. This was confirmed during interview with the technical consultant on the day of survey. D5781