RA-22-0058, 10CFR26.719(c)(1) Report - Unsatisfactory Performance of a Health and Human Services Certified Lab

10CFR26.719(c)(1) Report - Unsatisfactory Performance of a Health and Human Services Certified Lab

ML22041A533
Person / Time
Site:	Oconee
Issue date:	02/10/2022
From:	Mcneely M Duke Energy Carolinas
To:	Document Control Desk, Office of Nuclear Security and Incident Response
References
RA-22-0058
Download: ML22041A533 (3)

Text

Mark McNeely General Manager Nuclear Protective Services 526 South Church Street, EC05ZA-HYB Charlotte, NC 28202 980-373-6371 Mark.McNeely@duke-energy.com Serial: RA-22-0058 10 CFR 26.719(c)

February 10, 2022 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 OCONEE NUCLEAR STATION, UNIT NOS. 1, 2 AND 3 DOCKET NOS. 50-269, 50-270, AND 50-287 / RENEWED LICENSE NOS. DPR-38, DPR-47, AND DPR-55

SUBJECT:

10 CFR 26.719(c)(1) Report - Unsatisfactory Performance of a Health and Human Services Certified Laboratory Ladies and Gentlemen:

In accordance with 10 CFR 26.719(c)(1), Duke Energy Carolinas, LLC and Duke Energy Progress, LLC (collectively referred to as Duke Energy) is submitting a 30-day report detailing unsatisfactory performance of a Health and Human Services (HHS) Certified Laboratory.

10 CFR 26.719(c) stipulates in part that licensees shall notify the NRC within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered at either a licensee testing facility or an HHS-certified laboratory in the testing of quality control or actual specimens that could adversely reflect on the integrity of the random selection or testing process.

The enclosure to this letter provides a summary of the issue and planned corrective actions.

This letter contains no new commitments. Should you have any questions, please contact Teddy Reed at (704) 471-5851.

Sincerely, Mark McNeely General Manager, Nuclear Protective Services

Enclosure:

10 CFR 26.719(c)(1) Report, Unsatisfactory Performance of a Health and Human Services Certified Laboratory

U.S. Nuclear Regulatory Commission RA-22-0058 Page 2 cc:

L. Dudes, USNRC, Region II Regional Administrator S. Williams, USNRC NRR Project Manager for ONS J. Nadel, USNRC Senior Resident Inspector for ONS P. Harris, Senior Program Manager - Security Programs and Support Branch B. Zaleski, FFD Specialist - Office of Nuclear Security and Incident Response

RA-22-0058 Enclosure, Page 1 ENCLOSURE TO RA-22-0058 10 CFR 26.719(c) Report Unsatisfactory Performance of a Health and Human Services Certified Laboratory Summary of Issue:

On December 9, 2021 Duke Energy Corporate Access Services was notified by LabCorp of Research Triangle Park (RTP) that specimen identification (SPID) number 0106979776 which was submitted on November 30, 2021 was missing. The Lab had conducted a thorough physical search of their facilities and reviewed their shipping and tracking records but were not able to locate the specimen. On December 11, 2021 the specimen was received at the RTP Lab with seals intact. It was tested and results reported to Duke Access Services. The lab failed to report the results within five (5) business days as required by 10 CFD 26.169(a). Investigation by the Lab revealed that the specimen was received at RTP on November 30, 2021 and was inadvertently forwarded to their Houston lab with an inter-laboratory specimen transfer. Upon receipt, the Houston lab returned the specimen to RTP but did not communicate this to RTP lab management. Apparently the sorting process in place at the RTP lab was insufficient to ensure that only designated specimens are eligible for inter-laboratory transfer.

Corrective Actions:

1. On December 13, 2021 RTP revised their shipping protocol for inter-laboratory transfer to require visibility of specific information on the enclosed Custody and Control Form as a pre-requisite for transfer.

2. Management of other LabCorp labs have been made aware of the revised protocol.

3. The LabCorp investigation report will be reviewed to determine if barriers can be implemented at Duke Energy.