RBG-47784, Unsatisfactory Blind Quality Assurance Drug Testing Samples
| ML17249A812 | |
| Person / Time | |
|---|---|
| Site: | River Bend  |
| Issue date: | 09/06/2017 |
| From: | Schenk T Entergy Operations |
| To: | Document Control Desk, Office of Nuclear Security and Incident Response |
| References | |
| RBF1-17-0105, RBG-47784 | |
| Download: ML17249A812 (2) | |
Text
Entergx RBG-47784 September 6,2017 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555 Entergy Operations, Inc.
River Bend Station 5485 U.S. Highway 61 N SI. Francisville, LA 70775 Tel 225-381-4157 Timothy A. Schenk Manager - Regulatory Assurance
SUBJECT:
Unsatisfactory Blind Quality Assurance Drug Testing Samples River Bend Station - Unit 1 Docket No. 50-458 License No. NPF-47 RBF1-17-0105
Dear Sir or Madam:
On August 14th, 2017 two blind quality assurance (QA) samples were submitted to a Health and Human Services (HHS)-certified laboratory. On August 15th, 2017 the reported analyses on both samples were inconsistent with the pre-certified, substituted and false negative values. Both the analyses were consistent with a negative result.
The River Bend medical review officer was informed of the condition, and a 24-hour notification to the NRC Operations Center was completed. The investigation of this condition was completed on August 31, 2017. 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 contains no new regulatory commitments. If you have any questions on this matter, please contact Mr. Matthew J. Deignan, Supervisor - Access Authorization / FFD at 225-381-4141.
TAS / dhw Attachment cc: U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Blvd.
Arlington, TX 76011-4511 NRC Sr. Resident Inspector P. O. Box 1050 St. Francisville, LA 70775
Attachment to RSG-47784 Page 1 of 1 At Quest Diagnostics in Lenexa, Kansas (Quest), specimen aliquotting is normally performed via an automated process. However, in this specific case, a manual aliquotting step was performed. The event was determined to be human error in performing this manual aliquotting step. Manual aliquotting is an infrequently-performed activity.
Confirmatory testing is always performed on a fresh aliquot from the original specimen.
Therefore, the likelihood of a false positive test result caused by an error involving manual aliquotting is remote.
The laboratory reanalyzed the entire load and confirmed that no other specimens for the account were adversely impacted. The entire staff that was involved in the preparation of automated aliquots for initial testing was instructed to refrain from manually pipetting specimens.
The standard operating procedures will be updated to include instructions if an unusual problem arises during the automated aliquotting process. This will ensure that all specimen aliquots are discarded and the batch is repeated in its entirety.
Quest is to provide in-service training on all employees involved in preparation of initial testing aliquots and will include review of standard operating procedures, updated laboratory practices, and the results of this investigation.
Accelerated blind QA sample testing will be performed by RSS Fitness-for-Duty (FFD) personnel over the next five months that will include five additional tests per month. These tests will be in addition to the 30 tests per quarter currently required by the FFD program. This additional testing, along with blind QA samples submitted by other Entergy nuclear plants to the same laboratory, is intended to increase the likelihood of detection of recurring aliquot sequencing error. The accelerated testing is being tracked in the corrective action program.