ND-23-0559, CFR26.719(c)(1) 30-Day Report for a Blind Sample Analysis Error
| ML23192A542 | |
| Person / Time | |
|---|---|
| Site: | Vogtle  |
| Issue date: | 07/11/2023 |
| From: | Coleman J Southern Nuclear Operating Co |
| To: | Office of Nuclear Security and Incident Response, Document Control Desk |
| References | |
| ND-23-0559 | |
| Download: ML23192A542 (1) | |
Text
Jamie M. Coleman Regulatory Affairs Director Vogtle 3 & 4 7825 River Road Waynesboro, Georgia 30830 706 848 6926 tel July 11, 2023 ND-23-0559 10 CFR 26.719(c)
Docket Nos.: 52-025 52-026 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Southern Nuclear Operating Company Vogtle Electric Generating Plant (VEGP) - Units 3 and 4 10 CFR 26.719(c)(1) 30-Day Report for a Blind Sample Analysis Error Ladies and Gentlemen:
In accordance with 10 CFR 26.719(c)(1), Southern Nuclear Operating Company hereby submits the enclosed report for a Department of Health and Human Services (HHS)-certified laboratory analysis error of a blind quality control sample.
This letter contains no regulatory commitments.
Should you have questions regarding the enclosed information, please contact Will Garrett at (706) 848-7154.
Respectfully submitted, Jamie M. Coleman Regulatory Affairs Director Vogtle 3 & 4 Southern Nuclear Operating Company JMC/CAC/sfr
Enclosure:
10 CFR 26.719(c)(1) 30-Day Report for a Blind Sample Analysis Error
U.S. Nuclear Regulatory Commission NL-23-0559 Page 2 of 2 cc:
Regional Administrator, Region ll VPO Project Manager Senior Resident Inspector - Vogtle 3 & 4 Director, Environmental Protection Division - State of Georgia
Southern Nuclear Operating Company ND-23-0559 Enclosure Vogtle Electric Generating Plant (VEGP) - Units 3 and 4 10 CFR 26.719(c)(1) 30-Day Report for a Blind Sample Analysis Error (This Enclosure consists of 2 pages, not including this cover page)
U.S. Nuclear Regulatory Commission ND-23-0559 Enclosure Page 1 of 2 Description of the Incident:
On June 3, 2023, a blind quality control specimen prepared for Southern Nuclear Operating Company (SNC) by ElSohly Laboratories as a Substituted sample that was submitted to a Department of Health and Human Services (HHS) Quest Diagnostics Laboratory in Norristown, Pennsylvania, was reported as a Negative, Dilute sample result. The sample submitted to Quest Diagnostics Laboratory was prepared as a blind sample with measured specific gravity concentration of 1.0000 and the absence of creatinine, which is considered a Substituted sample by the HHS guideline definitions. The sample was submitted to Quest Diagnostics Laboratory and received for testing on June 3, 2023, as a donor specimen.
The initial screening testing by Quest Diagnostics Laboratory resulted in negative results for all drugs and a creatinine of 7.9 mg/dL and a specific gravity of 1.0023. The creatinine and specific gravity results are within the ranges constituting a result of Dilute by HHS guidelines. Therefore, the sample result was reported on June 3, 2023, as Negative, Dilute.
After receipt of the inaccurate sample result, SNC requested that the sample be re-tested by Quest Diagnostics Laboratory. Upon request another aliquot of the sample was subjected to reanalysis with results of creatinine less than 1.0 mg/dL and specific gravity of 1.0000. These creatinine and specific gravity results are within the ranges constituting a result of Substituted by HHS guidelines. A corrected report with results of Specimen Substituted was reported to SNC on June 12, 2023.
After being informed of the initial test result error, the laboratory performed an internal investigation of the incident. Additionally, SNC obtained the assistance of a consultant expert in toxicology and workplace drug testing to conduct an investigation.
Cause:
The investigation conducted by Quest Diagnostics Laboratory concluded that human error during specimen aliquoting for initial screening was the most likely cause for the original test result.
Specifically, the laboratory stated that they believed the sample immediately preceding the sample in question may have splashed into the blind sample. The consultant expert investigation report states that he agreed that the most probable cause of this error was random human error and does not indicate a systematic error, which could cause a repeat error.
Corrective Actions:
The corrective actions conducted by Quest Diagnostics Laboratory included the following:
- 1. The laboratory reviewed all data for original testing of the sample in question. Their conclusion was that all documentation was complete and correct.
- 2. The laboratory re-tested all samples in the batch containing the sample in question. All original specimens were re-aliquoted for screening and tested in their original screening batch location. The results of this re-screening confirmed the accuracy of all original batch specimen validity test results (including creatinine and specific gravity) other than for the sample in question. The laboratory was therefore able to exclude misidentification, instrumentation, or quality control issues as the cause for the original test result. At that time the laboratory identified human error during specimen aliquoting for initial screening as the most likely cause for the original test result.
U.S. Nuclear Regulatory Commission ND-23-0559 Enclosure Page 2 of 2
- 3. In response to questions from SNC, the laboratory confirmed that as part of the review of the original test and re-test data that all creatinine values in the batch were reviewed and there were no other samples with a creatinine value of approximately 7.9 mg/dL meaning it was unlikely that there was switching or double aliquoting of another sample in the batch.
Specific gravity results of samples located near the sample in question were also reviewed.
- 4. The laboratory reviewed the issue with all appropriate laboratory personnel and performed re-training of all laboratory personnel involved in specimen aliquoting for screening batch preparation. That retraining was completed on June 13, 2023.
The corrective actions conducted by SNC included the following:
- 1. SNC requested that the sample be re-tested when the initial results were received.
- 2. SNC ceased sending samples to Quest Diagnostic Laboratories pending results of the retest and investigation. Donor samples were sent to another qualified laboratory until completion of the investigation.
- 3. SNC contacted ElSohly Laboratories and requested an investigation to ensure that the sample submitted was accurately tested and labeled as Substituted. ElSohly reported that the lot number for that sample was retested and verified as meeting the criteria (creatinine and specific gravity) for classification as a Substituted sample.
- 4. SNC reviewed results from other samples from that same lot of Substituted samples received by SNC and submitted to laboratories for testing. It was determined that the other samples from that lot had been submitted to LabCorp from VEGP Units 3 and 4, and to Quest Diagnostic Laboratories by VEGP Units 1 and 2, and all were reported correctly as Substituted.
- 5. SNC submitted questions to clarify specific details of the investigation after receipt of Quest Norristowns summary of investigation.
SNC reviewed the information provided by the laboratory and the consultant expert. The investigation results and corrective actions were found to be acceptable by SNC.