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, record review and staff interview the laboratory failed to use in date quality control (QC) materials in the sub-specialty of toxicology. Findings include: 1. Surveyor observation on 10/11/18 at 9:30 AM of the laboratory's QC materials for "UDT Multi-Controls" for toxicology screening tests revealed lot# D1843 (Level 1 and 2) with an expiration date of 12/31/19 are currently in use. Labels on the QC vials revealed the following: a. Level 1 vial was opened on 7/17/18 b. Level 2 vial was opened on 7/19/18 2. Record review of the above QC manufacturer's (Carolina Liquid Chemistries Corporation) package insert on 10/11/18 revealed the QC materials are only stable for 30 days once opened. 3. Staff interview with the general supervisor (GS) on 10/11/18 at 10:00 AM confirmed the laboratory was using the above expired QC materials for toxicology screening tests. The GS stated he/she was not aware the expiration date changes once the QC vials are opened. 4. The laboratory performs 50,000 toxicology screens annually. 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 --