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: Through observation and interview with laboratory staff it was determined that the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 6/19/2024 at 12:28 p.m. twenty-two out of twenty-two packages of BBL CultureSwab Collection and Transport System (Ref: 220109, Lot: 222088600 354H02, expiration date 04/30/2024) was observed in the laboratory, available for use beyond their expiration date. B) In an interview on 06/19 /2024 at 13:01 p.m. Laboratory Directory #1, as listed on the CMS-209 form, confirmed that the items, identified above, had exceeded their expiration date and were available for use. 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 --