Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Validation survey was conducted at the CMG Lynchburg Family Medicine Residency on December 4, 2019 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: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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, policy and procedures (P&P) review and an interview with the primary TP and technical consultant, the technical consultant failed to perform and document an annual competency assessment for one (1) of three (3) TP in 2018. Findings include: 1. Review of the CLIA CMS-209 form revealed 3 TP performing patient testing in 2018. 2. Review of the 3 TP records revealed a lack of documentation of an annual competency assessment for TP C in 2018. TP C had documentation of an annual competency assessment on 9/06/17 and 6 /18/19. The inspector requested to review an annual competency assessment for TP C in 2018. The documentation was not available for review. (See attached Personnel code list.) 3. Review of P&P "CMG: Laboratory Testing Personnel Competency Assessment CMG.01.16.301" revealed the following statement: "Competency evaluations is an ongoing process which will be documented twice per year during the employee's first year and annually thereafter." 4. An interview with the primary testing personnel and technical consultant at approximately 1:20 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 --