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 observations made during a tour of the laboratory and interviews with staff, it was determined the laboratory had supplies available for use when they had exceeded their expiration date. As evidenced by: A. During a tour of the laboratory at 09:30 on 03/22/2018, the surveyor observed 6 of 9 eSwab collection swabs used for wound cultures of Aerobic, Anaerobic and Fastidious Bacteria (lot #032A26 expiration 09/2017 and lot #128A07 expiration 04/2016) available for use when they had exceeded their expiration date. B. In an interview, at the time of the tour, the technical consultant (as listed on the form CMS-209) confirmed the supplies were available for use when they had exceeded their expiration. 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 --