Laboratory Corporation Of America Holdings

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Laboratory Corporation of America Holdings on 06/17/24 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), proficiency testing (PT) records, and an interview, the lab failed to rotate five of five chemistry and five of five hematology PT events among two testing personnel (TP) for the ten of ten events reviewed between September 29, 2022 up to the date of survey on 06/17/24. Findings include: 1. Review of the CMS-209 personnel form revealed two TP performing serum human chorionic gonadotropin (HcG) chemistry and hematology microscopy test procedures in the calendar year 2022, 2023 and up to the date of survey on 06/17/24. 2. Review of the American Proficiency Institute (API) PT records revealed that the same TP performed the following 10 events (TP-A): 2022- Chemistry, Serum HcG event 3, 2022- Hematology Microscopy event 3. 2023- Chemistry, Serum HcG event 1, 2 and 3, 2023- Hematology Microscopy event 1, 2 and 3. 2024- Chemistry, Serum HcG event 1, 2024- Hematology Microscopy event 1. In an interview with the technical consultant on 06/17/24 at 10 AM, they stated "Testing personnel B works at a affiliated site and performs PT there for the same modules. Moving forward, TP B will be rotated with this CLIA number." 3. An exit interview with the technical consultant on 06/17/24 at 11 AM confirmed the findings. 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 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Laboratory Corporation of America Holdings on 09/29/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview with the technical consultant, the lab director failed to review and sign two of five attestation statements reviewed. Events of record review include all three events in 2021 and two events in 2022. Findings include: 1. Review of the American Proficiency Institute (API) PT records revealed the lack of documentation by the lab director for review and signature of the following: 2021 Hematology 3rd event attestation statement and 2022 Hematology 2nd event attestation statement. 2. An exit interview with the technical consultant on 09/29/22 at approximately 11:00 AM confirmed the findings. 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 --