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 laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 7/29/25 at 10:55 am, thirty BD ESwab Collection & Transport System for Aerobic, Anaerobic & Fastidious Bacteria Lot # 1440069000 expiration date 2025- 07-12 were observed in a laboratory cabinet, available for use beyond the expiraton date. B) In an interview on 7/29/25 at 11:00 am the laboratory staff member ( #5 on the form CMS 209) confirmed that the items, identified above, had exceeded their expiration dates and were available for use in the laboratory. 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 --