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: Based on direct observation and interview with Testing Personnel (TP), the laboratory failed to ensure that the BD Vacutainer serum separator tubes (SST) were not used past the expiration date. Findings include: 1. Direct observation of the specimen collection laboratory area revealed 32 BD Vacutainer SST tubes lot number 1076257 with an expiration date of March 31, 2022. The date of the survey was April 15, 2022. 2. In an interview conducted on April 15, 2022, at approximately 10:30 AM, TP#6 confirmed the collection tubes were expired and that the laboratory used these tubes to collect patient specimens for its send-out tests. 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 --