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 (TP1) on 7/28/26, the laboratory failed to discard supplies that exceeded their expiration date. During a tour of the laboratory at approximately 1:15 p.m., the surveyor observed 5 Aptima Swab Collection Kits (lot #90801V, expiration date 4/30/26) in a drawer, available for use. The expired collection kits were stored among Aptima Swab Collection Kits that were not expiring until October 2026. During an interview at approximately 1:30 p.m., TP1 confirmed the collection kits are used approximately two times per week for reference lab testing. She stated that all personnel are responsible for throwing away expired supplies each day. 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 --