Carilion Clinic Fm-West Salem

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Carilion Clinic Family Medicine (FM)-West Salem on May 19, 2026 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: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records and interview, the laboratory failed to rotate hematology PT among testing personnel (TP) performing Complete Blood Count (CBC) patient testing by having one of five TP perform five of six modules during the 25 months reviewed (timeframe April 11, 2024 to May 19, 2026). Findings include: 1. Review of the CMS 209 form revealed that the laboratory director identified five TP who were qualified and performed CBC patient testing on the Medonic M Series hematology analyzer during the 25 months of review. 2. Review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) PT records (2024 Events 2-3, 2025 Events 1-3, 2026 Event 1) a total of six events, revealed that TP A performed/signed attestations for the following CBC modules: WSLH 2024 Event 2 WSLH 2024 Event 3 WSLH 2025 Event 2 WSLH 2025 Event 3 WSLH 2026 Event 1 TP A performed five of six events reviewed (See Personnel Code Sheet). 3. An interview with the technical consultant on 5/19/26 at 12 PM confirmed the above findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT 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 -- CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, procedures, manufacturer's user guide, statistical quality control (QC) reports, lack of documentation, and interviews, the laboratory failed to ensure their monthly monitoring of control failures, shifts, and trends followed their procedure and manufacturer's user guide for patient Complete Blood Count (CBC) testing for 25 of 25 months reviewed (survey timeframe: April 11, 2024 - May 19, 2026). Findings: 1. During a review of the laboratory's PT records, the inspector noted that on their 2025 Wisconsin State Laboratory of Hygiene (WSLH) Hematology Event 1 that the laboratory received a score of 80 percent for Hematocrit (HCT). WSLH scored the five HCT challenges as: AT 1 reported 37.2 (acceptable range 36.7-39.7) AT 2 reported 36.8 (acceptable range 36.7-39.7) AT 3 reported 15.8 (acceptable range 15.5-16.7) AT 4 reported 15.1 (acceptable range 15.5- 16.7) --noted as unacceptable AT 5 reported 50.4 (acceptable range 50.3-54.5) The inspector noted that the laboratory's HCT scores were shifted low in comparison to acceptable range (assayed on 2/5/25) . The inspector noted a "PT Failure Correction Action Worksheet" attached to the CBC PT module (completed on 8/28/25) and a TP had documented on the

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Clinic West Salem on March 11, 2020 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: D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of the laboratory's Centers for Medicare and Medicaid Services (CMS) 116 form, policy and procedures (P&P), lack of documentation, and interview with the Technical Consultant (TC) and testing personnel, the laboratory failed to implement a mechanism to ensure the accuracy of manually transcribed patient results from instrument printouts into the EPIC electronic health record (EHR) for twenty (20) of 20 months reviewed. Findings include: 1. Review of the laboratory's CMS-116 revealed the laboratory performs Complete Blood Counts (CBC) using the Medonic M-series instrument (serial number 22953). An interview with the TC on 3/11/20 at approximately 11:20 AM revealed manual entry of patient results from the above listed analyzer printouts into the EHR, EPIC. 2. Review of P&P revealed lack of documentation of a procedure or mechanism to detect clerical errors for manually entered test results. Record review from June 1, 2018 and up to February 28, 2020 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 -- revealed no documentation of a review of manually transcribed patient test results. 3. An interview with the testing personnel and TC on 3/11/20 at approximately 11:50 AM confirmed the findings. -- 2 of 2 --