Carilion Clinic Family Medicine - Colonial Ave

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Carilion Clinic Family Medicine-Colonial Ave was conducted on 09/19/23 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies are as follows: D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and an interview, the laboratory failed to participate in one of four Complete Blood Count (CBC) events reviewed. Record review included second and third events in 2022 and first two events in 2023. Findings include: 1. Review of the CASPER 0155D Individual Laboratory Profile Report for the second and third event scores in 2022 and the first two events in 2023 and the Wisconsin State Laboratory of Hygiene (WSLH) PT records for the first event in 2023 revealed the laboratory received a score of 0% on 2023 Event 1- 0%- for the CBC module (Notation by WSLH-No results received). 2. An exit interview with the technical consultant on 09/19/23 at 1415 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 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Carilion Family Medicine- Colonial AVE on November 20, 2020 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 October 19, 2020 with off-site record review of documentation and a follow-up phone conference on November 13, 2020. 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 with the technical consultant (TC), the TC failed to perform and document the semi-annual competency assessment for one (1) of 1 new TP. Dates of record review include June 3, 2019 up to November 20, 2020. Findings include: 1. Review of the CMS-209 form revealed that TP A was trained and performing patient testing on June 10, 2019. 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. The review revealed a competency assessment performed June 10, 2019 and June 11, 2020. No other documented competency assessment was available for review upon request. 3. An interview with the TC on November 20, 2020 at approximately 10:30 AM 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 --