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 observation and interview with technical supervisors (TS) on 10/31/18, the laboratory failed to discard materials that had exceeded their expiration dates and were available for use. Findings. At 2:30 p.m., the surveyor observed the following items in laboratory's refrigerator on the second, third and bottom shelves. a. Amphetamine Urine Calibrator, Lot Number E30133, with the Expiration Date 2018- 03-31; b. Amphetamine Urine Control Set, three bottles, Lot Number EK16324, with the Expiration Date 2018-029-30; c. DRI Ethyl Glucuronide 625 mg/ml control, Lot Number 7246703, with the Expiration Date 2018-05; d. DRI Multi Drug Urine Calibrator 4, Lot Number 72799610, with the Expiration Date 2018-08-03; e. MDC Control Set 2, Lot Number EK16014, with the Expiration Date 2018-05-31; f. MGC Primary DAU High Control, two bottles, Lot Number 72457850, with the Expiration Date 2018-06; and, g. MCG Primary DAU High Control, two bottles, Lot Number 72457848, with the Expiration Date 2018-06. During interview with TS at 3:00 p.m., it was stated that these items were no longer being used and should have been properly disposed of by the staff. 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 --