Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Endocrinology Associates, INC on December 12, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included a follow up interview with the laboratory manager on 12/13/24. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), quality assessment (QA), proficiency testing (PT) and quality control (QC) documentation, personnel files, and interviews, the laboratory did not establish/follow a policy for technical consultant's (TC) competency assessment for one of two years reviewed (survey timeframe: December 12, 2022 to the date of the validation on December 12, 2024). Findings include: 1. During an interview with the laboratory manager on 12/12/24 at 10 AM while reviewing the CMS 209 personnel form, it was revealed that two personnel qualified and served as TC during the validation survey timeframe of 12/12/22 to 12/12/24. 2. During a review of the laboratory's QA, PT, and QC notebooks' documentation, the inspector noted that Personnel A reviewed and reported