Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and interview with Testing Personnel (TP) and the Technical Consultant (TC) on 8/29/25, the laboratory failed to discard supplies that were past their expiration dates for use. Findings: During a tour of the laboratory at approximately 12:25 p.m., the surveyor observed a white basket filled with Universal Transport Flocked Sterile Swabs, available for use, located near red-topped Universal Viral Transport Medium vials. Eight of the Universal Transport Flocked Sterile swabs were past their expiration date, including 6 expired on 06-16-2025 and 2 expired on 03-15-2025. The remaining swabs were within their dates for use. During an interview at approximately 12:30 p.m., TP #1 confirmed the BD Universal Transport Flocked Sterile Swabs are used to inoculate the red-topped Universal Viral Transport Medium. During an interview at approximately 12:35 p.m., the TC stated the swabs in the basket were recently checked for expiration but the few that were observed were not expired. 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 --