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 upon direct observation during a tour of the laboratory, review of manufacturer's reagent labels and staff interview, the laboratory failed to ensure that reagents in use were not expired. Findings were: 1. During a tour of the lab the surveyor observed the Blood Bank Saline - Standard Solution, Stabilized Isotonic Saline, Azer Scientific Brand, lot # 13323 with unopened expiration date of 11/30 /2019 had an open date recorded on the box of 7/1/2018. The manufacture label on the box states, "Consume entire contents within 30 days of opening." Observation was made on 11/29/2018, which made the saline expired by 121 days. This Blood Bank Saline is used by Kingman Community Hospital to perform blood bank testing (i.e., ABO RH typing, washing red blood cells, and cross matching.) This was confirmed by interview with the Technical Consultant #2 at 11:41 am on November 29, 2018 in the laboratory. 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 --