Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at LabCorp on 02/14/2024 by South Carolina Department of Environmental Control (SCDHEC). The laboratory was surveyed under 42 CFR Part 493 CLIA Requirements. Specific standard level deficiencies cited are as follows: 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 review of laboratory policy, the laboratory failed to ensure expired quality control (QC) material was not available for use for 2 of 2 days in 2024 (02/13/2024 and 02/14/2024). Findings included: 1. During the laboratory tour on 02/14/2024 at 11:10am controls were removed from the refrigerator by the general supervisor (GS) in a small cup with a lid on it. On top of the lid a piece of white tape had two dates written, top date was written with a marker and was smudged 1/29/24 and the second date written underneath was written with a different ink "exp 2/12/24". 2. Sysmex, e-Check (XS), hematology control for Sysmex XS- Series analyzers package insert in section titled, "Storage and shelf life after first opening" stated "Opened and recapped vials and vials whose caps have been pierced will retain stability for 14 days if stored at 2-8C." The laboratory failed to ensure expired QC material was not available for use. Word Key: C=Celsius Exp=expired 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 --