0CAN121901, Summary of Lost Specimens Investigation Report

Summary of Lost Specimens Investigation Report

ML19337C019
Person / Time
Site:	Arkansas Nuclear
Issue date:	12/03/2019
From:	Arnold T Entergy Operations
To:	Document Control Desk, Office of Nuclear Security and Incident Response
References
0CAN121901
Download: ML19337C019 (5)

Text

Entergy Operations, Inc.

1448 S.R. 333 Russellville, AR 72802 Tel 479-858-7826 Timothy L. Arnold Manager, Regulatory Assurance Arkansas Nuclear One 0CAN121901 10 CFR 26.719 December 3, 2019 ATTN: Document Control Desk U. S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Summary of Lost Specimens Investigation Report Arkansas Nuclear One - Units 1 and 2 NRC Docket Nos. 50-313 and 50-368 Renewed Facility Operating License Nos. DPR-51 and NPF-6

Dear Sir or Madam:

On September 12, 2019, Arkansas Nuclear One (ANO) Fitness-for-Duty (FFD) Staff confirmed a loss of drug testing samples that was sent to the Quest Diagnostics Health and Human Services-certified laboratory in Lenexa, Kansas, for analysis on August 30, 2019.

The ANO FFD Staff completed an investigation pertaining to the loss of the samples on November 5, 2019, and pursuant to the reporting requirements of 10 CFR 26.719(c)(1), the investigation results and corrective actions are documented in the Attachment to this letter.

This report includes no new regulatory commitments.

If you have any questions or require additional information, please contact Jerry Woods, Supervisor, ANO FFD, at 479-858-7846.

Sincerely, ORIGINAL SIGNED BY DONNA K. BOYD ACTING FOR TIMOTHY L. ARNOLD TLA/ble

Attachment:

Summary of Lost Specimens Investigation Report

0CAN121901 Page 2 of 2 cc: Mr. Scott A. Morris Regional Administrator U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 NRC Senior Resident Inspector Arkansas Nuclear One P. O. Box 310 London, AR 72847 U. S. Nuclear Regulatory Commission Attn: Mr. Thomas J. Wengert MS O-8B1A One White Flint North 11555 Rockville Pike Rockville, MD 20852

Attachment to 0CAN121901 Summary of Lost Specimens Investigation Report

Attachment to 0CAN121901 Page 1 of 2 Summary of Lost Specimens Investigation Report Identification of Error:

A package containing 3 Fitness for Duty specimens (Specimen #s 0540419, 0540420, and 0540421) was shipped to Quest Diagnostics, Health and Human Services (HHS)-certified laboratory in Lenexa, Kansas on August 29, 2019. When results were not reported and the five day report window approached, Arkansas Nuclear One (ANO) Fitness for Duty (FFD) personnel contacted the lab to obtain a status of the specimens. They were advised by Quest personnel that there was no record of the specimens in the lab. Using the FedEx tracking application it was confirmed that the specimens had been delivered to the lab on August 30, 2019. A proof of delivery from FedEx was provided to the Quest laboratory to assist in locating the missing specimens. The logistics department at the Quest laboratory was asked to locate the missing specimens. All efforts to locate the specimens were unsuccessful.

Investigation:

The ANO Medical Review Officer (MRO) was notified of the missing specimens and an inquiry was made to the Quest laboratory. In a letter provided by the Quest Diagnostics Director of Laboratory Operations & RP on November 1, 2019, the process of receiving and processing specimens was outlined. It was noted that the laboratory receives over 6000 packages from FedEx daily. The shipping label/air bill from each package is scanned with a FedEx scanner documenting receipt of the individual package. Once packages are scanned, they are placed into a bin and subsequently opened and the contents removed and sorted by specimen type and/or regulatory mode and placed into batch bins. The empty shipping containers (bags/boxes) are discarded into trash bags and set aside. When there are a sufficient number of specimens in a bin, the bin is then transferred to the forensic accessioning area where they are logged into the laboratory information system. At this point, the laboratory is unable to identify the individual specimens received in each package and its associated air bill.

The laboratory already had in place multiple quality checks to aid in preventing the inadvertent discard of specimens. Per the Director of Laboratory Operations & RP, all trash bags containing the empty shipping containers are placed into an X-ray scanner, as well as all FedEx shipping containers are viewed through the X-ray scanner to ensure no specimens have been discarded.

Large boxes containing specimens are broken-down to ensure all specimens have been removed, and the individual trash bins by each accessioners desk are also processed through the X-ray scanner to prevent inadvertently discarding specimens.

==

Conclusion:==

The missing specimens were delivered to the Quest - Lenexa laboratory on August 30, 2019.

However, the specimens were never received in the laboratory for processing. The logistics department at the laboratory was unable to locate the missing specimens. Although it cannot be definitively concluded, information provided by the laboratory suggests that the FedEx container with the three missing specimens were inadvertently discarded after being delivered and received by laboratory personnel.

Attachment to 0CAN121901 Page 2 of 2 Immediate Actions:

The MRO for ANO was notified and directed that the specimens be recollected.

The three missing specimens were recollected as soon as reasonably practical and submitted to the laboratory for testing.

A condition report was initiated.

An investigation was conducted.

Additional Corrective Actions:

The laboratory has reviewed this issue with forensic processing staff and has emphasized their policies and procedures that are designed to prevent the accidental discarding of specimens.

No other actions are indicated at this time.