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 a review of the MEDTOX Toxicology Urine Control package insert and Urine Drug Screen Control log, observations made during a tour of the laboratory, and interviews with laboratory staff, it was determined the laboratory used the MEDTOX controls when they had exceeded their expiration date. Survey findings include: A. A review of the MEDTOX Toxicology Urine Control package insert revealed the following statement on the stability of the control after opening: "The controls are stable for 31 days or until the expiration date, whichever comes first, when stored tightly capped at 2 - 8 degrees C (Celsius)". B. During a tour of the laboratory, at 10: 52 on 3/16/2022, the surveyor observed positive and negative MEDTOX controls (lots #CC00948 and #N00168-2) stored in the refrigerator, at 2 - 8 degrees C. The bottles were not labeled with the date opened or the expiration date (31 days after opening). C. Employee #5 (as listed on the form CMS-209) stated, in an interview at 10:52 on 3 /16/2022, that the current bottles of control had been in use since she started testing in early February 2022. D. Through a review of the Drug Screen Control log it was determined the date that Employee #5 started reporting quality control was 2/7/2022. With the last documented use on 3/14/2022 (35 days after the first use and four days after the open bottle 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 --