ML24305A130
| ML24305A130 | |
| Person / Time | |
|---|---|
| Site: | Summer  |
| Issue date: | 10/31/2024 |
| From: | Lawrence D Dominion Energy South Carolina |
| To: | Office of Nuclear Reactor Regulation, Document Control Desk, Office of Nuclear Security and Incident Response |
| References | |
| 24-315 | |
| Download: ML24305A130 (5) | |
Text
Dominion Energy South Carolina, Inc.
5000 Dorninior1 Boulevard, Glen Allen. VA 23060 Dom in ior1E nergy.com October 31, 2024 United States Nuclear Regulatory Commission Attention: Document Control Desk Washington, DC 20555-001 DOMINION ENERGY SOUTH CAROLINA, INC.
VIRGIL C. SUMMER NUCLEAR STATION UNIT 1 SUBMISSION OF FITNESS FOR DUTY REPORT Dominion Energye 10 CFR 26.719(c)
Serial No.:
NRA/AF:
Docket No.:
License No.:
24-315 R1 50-395 NPF-12 Pursuant to 10 CFR 26.719(c)(1), Dominion Energy South Carolina, Inc. (DESC) is reporting a drug testing error discovered in testing at Quest Diagnostics (Quest) in Norristown, PA, a Department of Health and Human Services (HHS)-certified laboratory.
On August 28, 2024, DESC submitted an observed collection sample (Specimen 2873778) to Quest for an individual requesting unescorted access (UA) to Virgil C.
Summer Nuclear Station Unit 1 (VCSNS). Initially, the test result for the sample was determined to be negative. When the test results were sent to the Medical Review Officer (MRO) for final determination, the MRO declared the test a "refusal" based upon the difference in temperatures from the initial sample and the observed collection sample as well as the level of creatinine in the sample. The individual was not granted UA to VCSNS, and the appropriate information was entered into the Personnel Access Data Systems (PADS) database.
On September 3, 2024, the Dominion Energy, Inc fleet Fitness for Duty (FFD} Testing Coordinator discovered the lab report on Specimen 2873778 did not have the appropriate message stating the specimen was tested in accordance with 10 CFR 26.163(a)(2)(i).
Quest was contacted to determine if the specimen was tested to Limit of Quantitation (LOQ) or if the report was missing the required message. On September 5, 2024, Quest reported back with an updated lab report stating the specimen was positive for cocaine with a Limit of Detection (LOO) message but not an LOQ message. The updated report was subsequently provided to the MRO; however, no further action was necessary since the individual was previously denied access. Quest was again contacted regarding the LOQ message, since regulation requires confirmatory testing to LOQ and not LOO. A corrected report was provided by Quest on September 13, 2024.
Dominion Energy, Inc performed an extent of condition review of all observed collection sample results since October 1, 2023 to determine if there were any additional reporting errors. There were no additional reporting errors identified.
Quest performed an investigation into this incident. The Quest investigation, which includes corrective actions that were taken, is provided as Attachment 1 to this letter.
Serial No.: 24-315 Docket No.: 50-395 Submission of Fitness for Duty Report Page 2 of 2 Quest no longer performs testing services for Dominion Energy at the Norristown, PA location, but continues to provide services at the Lenexa, KS location.
If there are any questions regarding this submittal or if additional information is needed, please contact Mr. Allen Fulmer at (803) 543-2501.
Douglas awrence Senior Vice President - Nuclear Operations and Fleet Performance Commitments made in this letter:
None Attachments: - Quest Diagnostics Investigation cc:
U.S. Nuclear Regulatory Commission, Region II Marquis One Tower 245 Peachtree Center Avenue, NE Suite 1200 Atlanta, Georgia 30303-1257 NRG Senior Resident Inspector Virgil C. Summer Nuclear Station Mr. G. Edward Miller NRG Senior Project Manager U.S. Nuclear Regulatory Commission One White Flint North Mail Stop O-9E3 11555 Rockville Pike Rockville, Maryland 20852-2738 Mr. Gregory Lindamood Santee Cooper - Nuclear Coordinator 1 Riverwood Driver Moncks Corner, SC 29461 Quest Diagnostics Investigation Virgil C. Summer Nuclear Station Dominion Energy South Carolina Serial No.: 24-315 Docket No.: 50-395
October 15, 2024 Ms. Angela Timmons Fitness for Duty Testing Coordinator Dominion Energy 701 E Cary Street Richmond, VA 23219 RE: Specimen ID 2873778; Collection Date 8/28/24; Received 8/29/24 Specimen ID 2873992, Collection Date 9/11 /24; Received 9/12/24
Dear Ms. Timmons:
I am providing this letter for the 30 day report you requested September 16, 2024 regarding missed Limit of Quantitation evaluation on the two observed collections noted above. Both specimens were received and tested at the Norristown, Pennsylvania Quest Diagnostics laboratory.
In October 2023 Dominion Energy started using the new panel required by the Nuclear Regulatory Commission 10 CFR Part 26 published November 22, 2022. Prior to this transition, the certifying scientists were trained to perform additional data review for dilute and observed collections. Specimens that fell into these two categories required additional review for immunoreactivity greater than or equal to 40 percent of the cutoff calibrator. Additional LOQ testing was to be performed for dilute and observed collections if this condition was met. If not, a report comment was supposed to be added to note that analytes were not present above detectable levels on the immunoassay test. Computer prompts were added to flag dilute specimens for this additional review. Manual review was required for the certifiers to identify the observed collections as this is not a comment captured in our computer system.
Specimen ID 2873778 was received as an observed collection at Quest Diagnostics on August 29, 2024 and was reported August 29, 2024 without the additional review. You sent an e-mail to our customer service area September 3, 2024 and on September 5, 2024 a new report was issued listing both the original negative panel result and the presence of cocaine metabolite based on Limit of Detection evaluation.
Johnny Rogers from the Nuclear Energy Institute contacted Dr. Suhash Harwani, Senior Science Director at Quest Diagnostics, about the report. For cocaine metabolite testing in our laboratory, the Limit of Detection (LOO) and Limit of Quantitation (LOQ) values are the same. The certifying scientist used the incorrect message code for reporting. A revised report was issued September 13, 2024 that listed the negative panel result and the presence of cocaine metabolite based on Limit of Quantitation evaluation.
Specimen 2873992 was received as an observed collection at Quest Diagnostics on September 12, 2024 and was reported September 12, 2024 without the additional review. You sent an e-mail to our customer service area September 13, 2024 and a new report was issued September 17, 2024 with a message code to indicate no analytes were present above detectable levels on the immunoassay test.
On September 16, 2024 I received your email notifying me about these two incidents. Upon receipt of this notification, I reviewed the handling of these 2 specimens and had all NRC records on-site pulled to 400 Egypt Road Norristown, Pennsylvania 19403 QuestDiagnostics.com
retrospectively review the appropriate handling of observed collections. No omissions were found in our on-site records. You indicated in your notification that all your sites were asked to review their observed specimen results to ensure there were no additional missed LOO tests or message codes indicating the review was performed. You notified me September 17, 2024 of an observed collected on specimen ID 4729383 collected October 10, 2023 that did not have information included about additional review. A report was issued September 18, 2024 with a message code to indicate no analytes were present above detectable levels on the immunoassay test.
Our investigation noted that all 3 were missed by the same certifying scientist who had previously been trained on these requirements. Identifying observed collections is a manual process and this individual missed the collection comment on the Custody and Control Forms. Our laboratory site discontinued NRC testing September 14, 2024. As LOO evaluation and testing for observed collections is a unique requirement for NRC testing, no corrective action is warranted at this time.
Quest Diagnostics is committed to providing industry-leading forensic drug testing services. As such, the laboratory works very hard to eliminate human error in its laboratory operations and regrets any inconvenience experienced in these instances. Should you have any additional questions or concerns, please call me at (610) 631-4502.
Sincerely, Susan Mills Sr. Director, Laboratory Operations 400 Egypt Road Norristown, Pennsylvania 19403 QuestDiagnostics.com