ML20365A061

Per 10CFR26.719(c)(1), Unanticipated Result for FFD Performance Test Sample

ML20365A061
Person / Time
Site:	Palo Verde
Issue date:	12/30/2020
From:	Rash B Arizona Public Service Co
To:	Document Control Desk, Office of Nuclear Security and Incident Response
References
102-08199-BR/LMW
Download: ML20365A061 (4)

Text

10 CFR 26.719 BRUCE J. RASH Vice President Nuclear Engineering/Regulatory Palo Verde Nuclear Generating Station P.O. Box 52034 Phoenix, AZ 85072 Mail Station 7605 Tel 623 393 6491 102-08199-BR/LMW December 30, 2020 ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Palo Verde Nuclear Generating Station (PVNGS)

Units 1, 2, and 3 Docket Nos. STN 50-528/529/530 Unanticipated Result for a FFD Performance Test Sample Pursuant to 10 CFR 26.719(c)(1), Arizona Public Service (APS) Company hereby provides, as an enclosure to this letter, a report of an unanticipated result for a Fitness for Duty (FFD) performance test sample.

On July 29, 2020, the PVNGS FFD collection facility received from a Department of Health and Human Services (HHS) certified laboratory, a performance test result that was not consistent with the expected result. APS completed its investigation on December 2, 2020. Results of the investigation are documented in the enclosure to this letter.

APS makes no commitments in this letter. If you have questions regarding this submittal, please contact Matthew Kura, Department Leader, Nuclear Regulatory Affairs, at (623) 393-5379.

Sincerely, Digitally signed by Rash, Rash, Bruce Bruce (Z77439)

DN: cn=Rash, Bruce (Z77439)

(Z77439) Date: 2020.12.30 09:58:55

-07'00' BR/LMW Enclosure cc: S. A. Morris NRC Region IV Regional Administrator S. P. Lingam NRC NRR Project Manager for PVNGS C. A. Peabody NRC Senior Resident Inspector PVNGS

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ENCLOSURE Unanticipated Result for a FFD Performance Test Sample

ENCLOSURE Unanticipated Result for a FFD Performance Test Sample Description In accordance with 10 CFR 26.168, Arizona Public Service Company (APS) provides performance test samples which are submitted to the two contracted Department of Health and Human Services (HHS) certified laboratories for Fitness for Duty (FFD) specimen analysis for the Palo Verde Nuclear Generating Station (PVNGS) FFD program. The two laboratories are MedTox Laboratories Incorporated (MedTox) and Laboratory Corporation of America Holdings (LabCorp).

APS provided a split of two blind samples to both laboratories which were prepared from the same batch and positive for cocaine metabolite (benzoylecgonine). Each split sample was provided on July 28, 2020.

On July 29, 2020, the PVNGS FFD department received a laboratory report from MedTox that indicated a Negative/Normal test result for the blind test sample that was expected to indicate Normal/Positive.

The LabCorp blind test sample result was reported back as positive for benzoylecgonine on July 31, 2020, as anticipated.

The unanticipated performance test result from MedTox represented an unsatisfactory condition that was investigated by APS. The evaluation was completed on December 2, 2020. This report is submitted to the Nuclear Regulatory Commission (NRC) pursuant to 10 CFR 26.719(c)(1), to describe the condition and corrective actions, taken or planned.

Investigation Results Following the review of test results by the Medical Review Officer (MRO),

MedTox was notified on August 5, 2020, that the blind sample results were inconsistent with the expected result of Positive for Cocaine Metabolite.

APS also requested that MedTox perform re-confirmatory testing of an aliquot of the original split blind sample that was sent to LabCorp on July 28, 2020. Upon receipt of the aliquot, MedTox analyzed the blind sample and reported a positive result for benzoylecgonine, which was consistent with the expected result.

MedTox performed an investigation to determine the cause of the failure and provide an explanation of corrective actions taken.

Through their investigation, MedTox concluded that While it is possible that a mixing or an undetected sampling error could have occurred, the original specimen was disposed of prior to notification of the error so additional/repeat testing could not be performed to provide additional insight into the discrepancy.

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ENCLOSURE Unanticipated Result for a FFD Performance Test Sample On December 2, 2020, based on the MedTox investigation results and further correspondence, the investigation was considered completed although a definitive cause was not identified.

Actions Taken MedTox requested a special internal proficiency test set submitted as internal blind samples through their Quality Assurance (QA) department to monitor the assay performance. Two sets of double blind quality control samples (three per set) were submitted. These samples were received and tested as routine donor samples. The internal blind performance testing completed by MedTox revealed anticipated performance results.

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