Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Spero Health Virginia Core Lab on September 5 & 6, 2024 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: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the policy and procedure (P&P), lab test menu, proficiency testing records (PT), lack of documentation, and interviews, the laboratory failed to review and sign the PT results for 47 of 47 urine toxicology analytes for seven of ten events in 2023 and 2024. Findings include: 1. Review of the policy "Proficiency Testing and Employee Competency" revealed the following statement, "The results will be reviewed by the lab director and/or designee, and any failed results will be investigated, and