ULNRC-06471, Specimen Handling Error, Per 10CFR26.719(c)(1)

Specimen Handling Error, Per 10CFR26.719(c)(1)

ML18320A245
Person / Time
Site:	Callaway
Issue date:	11/16/2018
From:	Mclachlan M Ameren Missouri
To:	Document Control Desk, Office of Nuclear Reactor Regulation, Office of Nuclear Security and Incident Response
References
ULNRC-06471
Download: ML18320A245 (4)

Text

I Ame MISSOURI refl Callaway Plant November 16, 2018 ULNRC-0647 1 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-000 1 10 CFR 26.719(c)(1)

Ladies and Gentlemen:

DOCKET NUMBER 50-483 CALLAWAY PLANT UNIT 1 UNION ELECTRIC CO.

RENEWED FACILITY OPERATING LICENSE NPF-30 SPECIMEN HANDLING ERROR The enclosed report is submitted pursuant to 1 0 CFR 26.719(c)(1) in regard to an error that resulted in two donors specimens being switched prior to testing at the laboratory utilized for Callaway Plants Fitness for Duty program. The report describes the error that occurred as well as the corrective action taken.

No new commitments are identified in this correspondence, and none ofthe material in this report is considered proprietary by Ameren Missouri Callaway Plant.

If you have any questions or require additional information, please contact Mrs. Amy Findley, Supervisor ofAccess Authorization and Fitness for Duty at 573-676-4435.

Sincerely, Mark A. McLachlan Sr. Director Plant Support Enclosure 83 15 County Road 459 :. Steedman, MO 65077 :. AmerenMissouri.com

ULNRC-0647 1 November 16, 2018 Page 2 of 3 cc: Mr. Kriss M. Kennedy Regional Administrator U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Senior Resident Inspector Callaway Resident Office U.S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. L. John Klos Project Manager, Callaway Plant Office ofNuclear Reactor Regulation U. S. Nuclear Regulatory Commission Mail Stop O9E3 Washington, DC 20555-0001

ULNRC-0647 1 November 16, 2018 Page 3 of 3 Index and send hardcopy to QA File A160.0761 Hardcopy:

Certrec Corporation 6100 Western Place, Suite 1050 Fort Worth, TX 76107 (Certrec receives ALL attachments as long as they are non-safeguards and may be publicly disclosed.)

Electronic distribution for the following can be made via Other Situations ULNRC Distribution:

F. M. Diya B. L Cox M. A. McLachlan S. P. Banker B. L. Brown R. C. Wink T. B. Elwood A. C. Findley M. W. Haglund Corporate Communications NSRB Secretary STARS Regulatory Affairs Mr. Jay Silberg (Pillsbury Winthrop Shaw Pittman LLP)

Missouri Public Service Commission

Enclosure to ULNRC-0647 1 November 16, 2018 Page 1 of 1 Specimen Handling Error On September 24, 201 8, a Fitness for Duty (FfD) Coordinator at the Callaway Plant logged into the Clinical Reference Laboratorys (CRL) Oasis website to view FFD specimen results for samples that had previously been submitted for two donors. for each donor, A and B specimen bottles had been provided. The coordinator observed that the results were listed as rejected for testing due to the donors specimen bottles being switched. Specimens for both donors were recollected and sent to a different laboratory, Laboratory Corporation of America Holdings (LabCorp), for testing. No issues were identified in the results for the two donors.

Investigations took place at the Callaway Plant and CRL to determine the events that led to the switching of specimen bottles. The investigations led to conflicting conclusions. The CRL investigation report indicated that upon arrival, the accessioner identified a switch in the B specimen bottles for the two donors and that the accessioners supervisor verified the bottle switch. The investigation report stated that no actions were taken that could have caused or contributed to the inadvertent switching of specimens.

The Callaway Plant investigation, completed on October 1 8, 201 8, concluded that it is likely the specimen switch occurred at CRE. The collection process at the Callaway Plant only allows one collection to be performed at a time. The donor certifies that the A and B bottles contain the specimen provided by the donor, and the donor observes the chain of custody, including observing that the A and B specimen bottles are sealed in the tamper evident bag. In addition, in this case, one ofthe two donors specimen was being monitored by another member of management that observed the process from beginning to end including the sealing ofthe tamper evident bag. No actions leading to the switch in specimen bottles could be confirmed.

Corrective Action:

The Callaway Plant has administratively suspended CRL as the primary laboratory for employee specimen testing. The CRL contract will be maintained (as a backup lab) until another certified laboratory can be qualified.

Reportability:

1 0 CFR 26.71 9 states in part, (c) Drug and alcohol testing errors. (1) Within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing at either a licensee testing facility or an HHS-certified laboratory, in the testing of quality control or actual specimens, or through the processing ofreviews under § 26.39 and MRO reviews under

§

26. 185, as well as any other errors or matters that could adversely reflect on the integrity of the random selection or testing process, the licensee or other entity shall submit to the NRC a report of the incident and corrective actions taken or planned. Ifthe error involves an HHS-certified laboratory, the NRC shall ensure that HHS is notified of the finding.

This report is submitted pursuant to 10 CFR 26.719(c)(1) on the basis that the noted switching of samples could adversely reflect on the integrity of the testing process.