ML22089A248

Submittal of 30-Day Report Per 10 CFR 26.719(c) Unanticipated Results for FFD Performance Test Samples

ML22089A248
Person / Time
Site:	Palo Verde
Issue date:	03/30/2022
From:	Harbor C Arizona Public Service Co
To:	Document Control Desk, Office of Nuclear Security and Incident Response
References
102-08412-CDH/SPD
Download: ML22089A248 (3)

Text

10 CFR 26. 719

~l aps Cary D. Harbor Vice President Nuclear Regulatory &

Oversight Palo Verde Nuclea r Generating Station 102-084 12-CDH/SPD P.O. Box 52034 Phoenix, AZ 85072 March 30, 2022 Mail Station 7605 Tel 602 397 7036 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 Results for FFD Performance Test Samples Pursuant to 10 CFR 26. 719(c)(l), Arizona Public Service (APS) Company hereby provides, as an enclosu re to this letter, a report of unanticipated r esu lts for Fitness for Duty (FFD) performance test samples.

On November 8, 2021, and November 10, 2021, the PVNGS FFD collection facility received from a Depa rtment of Health and Human Services certified laboratory, performance test resul ts that were not consistent with the expected results. APS completed its investigati on on March 7, 2022. Results of the investiga tion are documented in the enclosure to this letter.

APS makes no commitments in this letter. If you have questions regarding this submittal, please conta ct Mike Dilorenzo, Department Leader, Nuclear Regulatory Affairs, at (623) 393-3495.

Sincerely, CDH/SPD

Enclosure:

Unant icipat ed Results for FFD Performance Test Samples cc: S. A. Morris NRC Region IV Regional Administrator S. P. Lingam NRC NRR Project Manager for PVNGS L. N. Merker NRC Senior Resident Inspector PVNGS A member of t he STARS Alliance LLC Callaway

• Diablo Canyon

• Palo Verde

• Wolf Creek

ENCLOSURE Unanticipated Results for FFD Performance Test Samples

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 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 with no issues identified with the MedTox results.

On November 5, 2021 and November 10, 2021, LabCorp received blind performance test specimens from APS. On November 8, 2021, and November 10, 2021, the PVNGS FFD collection facility received unanticipated negative test results from LabCorp for both blind performance test specimens. APS identified that LabCorp had not performed either of the tests as requested, and instead conducted testing that did not include testing for Positive for Opioid Metabolites, resulting in the unanticipated negative test results.

The unanticipated performance test results from LabCorp represented an unsatisfactory condition that was investigated by both LabCorp and APS. APSs evaluation was completed on March 7, 2022. This report is being submitted to the Nuclear Regulatory Commission pursuant to 10 CFR 26.719(c)(1), to describe the condition and corrective actions taken by LabCorp.

Investigation Results LabCorp was notified on November 24, 2021 that the blind sample results were inconsistent with the expected result of Positive for Opioid Metabolites. APS requested LabCorp perform an internal investigation to determine the reason for the testing error and provide corrective action(s) taken and/or planned to mitigate and prevent reoccurrence.

LabCorp performed an investigation to determine the cause of the failures and provided an explanation of corrective actions taken and/or planned. The initial response provided by LabCorp on January 5, 2022, was rejected by APS as it lacked details on the cause of the error. LabCorp performed further evaluation of the issue and concluded that the error was a result of their data entry staff entering the incorrect drug testing profile information into their Laboratory Information Management System (LIMS) prior to testing the specimens.

On February 10, 2022, based on LabCorps internal investigation results and further correspondence, LabCorps investigation was considered complete.

Actions Taken LabCorp revised their standard operating procedure to require an additional step for a laboratory team leader to perform a second peer check for NRC tests prior to turning the record(s) over to Documents and Records. On February 1, 2022, LabCorp provided training to the data entry staff for entering the appropriate test information into the LIMS.