Carilion Clinic Fm-Daleville

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Clinic Family Medicine-Daleville on 03/14/22 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: The laboratory is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the review of the manufacturer operator's guide, lack of documentation, and interview, the lab failed to perform and document the monthly maintenance for the hematology analyzer for 11 of 12 months reviewed in 2021. Findings include: 1. Review of the manufacturer operator's guide revealed instructions for performing monthly cleaning procedures utilizing the Boule Cleaning Kit (cleaning procedure and clot prevention) listed under "Section 8: Cleaning, Maintenance & Transport", "8.2 Monthly Cleaning". 2. Review of the available maintenance records for the Medonic M-series analyzer (serial number 46469) revealed lack of documentation of the performance of the monthly maintenance for 11 of 12 months reviewed in 2021. The inspector requested to review aforementioned documents. The documents were not available for review. 3. An exit interview with the technical consultant and primary testing personnel on 03/14/22 at 1215 confirmed the findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 with the technical consultant (TC), the TC failed to perform and document the semi-annual competency assessment for one (1) of 1 new TP in 2021. Findings include: 1. Review of the CMS-209 form revealed that TP A was trained and performing patient testing on 01/12/21. See attached TP code sheet. 2. Review of TP A records revealed lack of documentation by the TC of performance and review of the semi-annual competency assessment. No other documented competency assessment was available for review upon request. 3. An exit interview with the TC on 03/14/22 at approximately 1215 confirmed that the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Carilion Family Medicine- Daleville on February 8, 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: 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 a review of the proficiency testing (PT) records and an interview, the laboratory director failed to sign one (1) of six (6) attestation statements reviewed. Findings include: 1. Review of the American Academy of Family Physicians PT records for all events for 2016 and 2017 (a total of six events) revealed the following attestation statements not signed by the laboratory director: 2017 Event A. 2. An interview with the technical consultant at approximately 11:45 AM confirmed that 1 of the 6 attestation statements reviewed was not signed by the laboratory director. 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 --