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 surveyor observation and interview with technical consultant (TC) 06/24/25, the laboratory failed to ensure 10 expired collection swabs were not available for use. Findings: During laboratory inspection the surveyor observed the following expired collection swabs in a cabinet on the bottom shelf: a. One "BD BBL Culture Swab Plus" collection swab, Lot #231292000 354038, Expiration Date 05/14/25. b. Nine "COPAN" collection swabs, Lot # 354014 L. 240408100, Expiration Date 03/19/25. Interview with TC at approximately 11:20 p.m. confirmed the swabs were expired. They stated it appeared someone from nursing may have placed the swabs on top of the bags of swabs in the cupboard because those swabs were not normally used by laboratory staff for the on-site laboratory testing. The swabs were immediately disposed of. 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 --