Centra Medical Group - Amherst

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Centra Medical Group Amherst on February 9, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on January 21, 2021 with off-site record review of documentation and a follow-up phone conference on February 3, 2021. 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 lab director, the lab director or designee failed to review and sign three (3) of 6 attestation statements reviewed. Events of record review include 3 events in 2019 and 3 events in 2020. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) PT records on February 3, 2021 revealed the lack of documentation of the lab director's or designee signature on the attestation statements for the following events: 2019 MLE 2, 2020 MLE A, 2020 MLE B. 2. An interview with the lab director on February 9, 2021 at approximately 10 AM confirmed the findings and the documents were corrected on-site. 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 Centra Medical Group- Amherst on September 20, 2018 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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel (TP) A competency records, and interviews, the technical consultant failed to perform the semi-annual competency evaluation for one (1) of one (1) new testing personnel in 2018. (see Attached Personnel Code Sheet). Findings include: 1. Review of the CMS 209: Laboratory Personnel form revealed that the laboratory director also performs the duties of technical consultant. 2. Review of TP A records revealed that TP A was hired in October 2017 and that there was no documentation of a semi-annual competency performed at the date of survey. The inspector requested to view aforementioned documentation. The documentation was not available for review. 3. An interview with the technical consultant at approximately 12:00 PM confirmed the above-listed 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 --