Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Validation survey was conducted at the Blue Ridge Cancer Care- Alleghany Virginia on August 5, 2021 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: D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview, the technical consultant (TC) failed to perform and document the semi-annual competency assessment for one (1) of 1 new TP. Dates of record review include July 1, 2019 up to July 29, 2021. Findings include: 1. Review of the CMS-209 form revealed the lab director performs the duties of TC and that TP A was trained and performing patient testing as of 02/05/20. See attached TP code sheet. 2. Review of TP A's records revealed lack of documentation by the TC of performance and review of the semi- annual competency assessment. The document was not available for review upon request. 3. An exit interview with the TP B on 08/05/21 at approximately 12:00 PM 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 --