Vpi And Student Health Services Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at VPI Student Health Center, Schiffert Health Center on March 5, 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: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, procedures, lack of documentation, and interview, the laboratory failed to evaluate four chemistry, one microscopy, and nine microbiology non-graded analyte challenges resulted on six of six events reviewed for calendar years 2024 and 2025. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT results (2024 Events 1-3, 2025 Events 1-3), a total of 6 events, revealed that API released non-graded analyte responses for: Total Bilirubin (T Bili) due to variance on the following 3 events: API 2024 Event 1 - T Bili challenge CH-02; API 2025 Event 2 - T Bili challenge CH-07; API 2025 Event 3 - T Bili challenges CH-12; Alkaline Phosphatase (ALKP) on the following event: API 2025 Event 2 - ALKP challenge CH-06; --a total of 4 non- graded Core Chemistry challenge samples were reported by API; Vaginal Wet Prep on the following event: API 2024 Event 2 - challenge VA-02; --a total of one non- graded microscopy challenge sample was reported by API; Urine Culture Susceptibility on the following 2 events: API 2024 Event 1 - Susceptibility UR-01 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 -- Trimethoprim/Sulfamethoxazole (Trimeth/Sulfa) API 2024 Event 2 - Susceptibility UR-06; Ciprofloxacin (Cipro) --a total of 2 non-graded microbiology urine culture susceptibility challenge samples were reported by API; Urine Culture MIC/Zone Value on the following: API 2024 Event 1 - challenge UR-01 Cipro, Nitrofurantoin, Trimeth/Sulfa; API 2024 Event 2 - challenge UR-06 Cipro; API 2024 Event 3 - challenge UR-11 Ampicllin (Amp), Cefoxitin, Cipro, API 2025 Event 1 - challenges UR-01 Amp, Cefoxitin, Cipro, Nitrofurantoin and UR-02 Amp; API 2025 Event 2 - challenges UR-06 and UR-07 Amp, Cefoxitin, Cipro, Nitrofurantoin; --a total of 7 non-graded microbiology urine culture MIC/Zone value challenge samples were reported by API. 2. Review of the laboratory's PT review documentation revealed no evaluation/verification of accuracy recorded for the non-graded challenge sample results outlined above. The inspector requested to review an evaluation for the non- graded challenges. The documentation was not available. 3. Review of the laboratory's procedures revealed a policy (title: Proficiency Testing Policy) that stated, "Nongraded and educational challenges are to be compared to the peer group and clearly documented on the evaluation form. PT results which are not graded due to lack of consensus, submitting results too late, failure to submit, etc. are to be reviewed by the manager with appropriate follow-up and documentation of

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the VPI and Student Health Services Laboratory on 12/20/23 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: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on the review of daily quality control (QC) records, lack of documentation, and interview, the lab failed to retain documentation of the daily complete blood count (CBC) QC procedures from 07/06/23 up to 08/29/2023 (49 days). Findings include: 1. Review of the Beckman Coulter DxH520 hematology QC records from 01/01/22 up to the date of survey on 12/20/23 revealed lack of documentation of daily CBC QC procedures from 07/06/23 up to 08/29/2023 (49 days). The inspector inquired about the lack of daily CBC QC documentation in an interview with the laboratory supervisor on 12/20/232 at 12:30. They stated, "we should have those records. We download the old lot number QC documents and print out those files prior to implementing the new lot number of QC materials." The lot number of CBC QC in question was 352315011, 362315012 and 372315013. 2. The laboratory supervisor provided the Beckman Coulter Interlaboratory Quality Assurance Program (IQAP) statistical commutative report for the above-specified lot number. The IQAP statistical commutative report did not include daily CBC QC results. The inspector inquired if the lab printed daily CBC QC results or if another source was available for review from 07/06/23 up to 08/29/2023 on 12/20/23 at 1300. The lab supervisor stated, "no 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 -- we do not print out daily CBC QC results. I'm not sure what happened during that timeframe." 3. An exit interview with the lab supervisor and primary testing personnel on 12/20/23 at 1400 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the VPI Student Health Center, Schiffert Health Center on 02/14/22-2/16/22 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The survey included on-site inspection of the main lab located at 895 Washington ST Blacksburg, VA and the molecular lab located at 4 Riverside Circle Roanoke, VA. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing at both sites and is in compliance with the applicable COVID-19 reporting requirements. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 a review of the Laboratory Personnel Report form (CMS 209), testing personnel (TP) files, and an interview, the technical supervisor (TS) failed to assess annual competency for one of six testing personnel the calendar year 2021 (main laboratory). Findings include: 1. Review of the CMS Form 209: Laboratory Personnel Report revealed that the laboratory director serves as the TS and there are six testing personnel in the laboratory. 2. Review of TP files revealed no competency assessment in 2021 for: Testing personnel A. (See Personnel Code Sheet.) 3. An exit interview with the general supervisor for the main laboratory at approximately 1600 on 2/14/22 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 survey was conducted at the VPI and Student Health Services Laboratory on October 8, 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: D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient test reports, lack of documentation, and interview with the technical consultant, the laboratory's Medicat Electronic Health Record (EHR) final patient report failed to contain reference intervals or normal values for two (2) urine colony counts, one (1) urine microscopy, and one (1) vaginal wet preparation examination at the date of survey on October 8, 2019. Findings include: 1. Review of patient test reports generated from the Medicat EHR revealed lack of documentation of reference intervals or normal values for 2 urine colony counts, 1 urine microscopy and 1 vaginal wet preparation examination. 2. An interview with the technical consultant at approximately 2:45 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 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at VPI and Student Health Center- Schiffert Health Center on February 7, 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: D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 a review of the Laboratory Personnel Report form (CMS 209), testing personnel (TP) files, and an interview, the technical supervisor (TS) failed to assess annual competency for one (1) of four (4) testing personnel for 2016 and 2017. Findings include: 1. Review of the CMS Form 209: Laboratory Personnel Report revealed that the laboratory director serves as the TS, and that there are four (4) testing personnel in the laboratory. 2. Review of TP files revealed no competency assessments in 2016 and 2017 for: Testing personnel A. (See Personnel Code Sheet.) 3. An interview with the general supervisor at approximately 2:45 PM on February 7, 2018 confirmed that the technical supervisor failed to assess competency for the TP listed above. 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 --