NL-14-1245, 10 CFR 26.719(c) Report: False Negative Results for a Blind Performance Test Sample

10 CFR 26.719(c) Report: False Negative Results for a Blind Performance Test Sample

ML14234A240
Person / Time
Site:	Hatch
Issue date:	08/22/2014
From:	Pierce C Southern Co, Southern Nuclear Operating Co
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
NL-14-1245
Download: ML14234A240 (5)

Text

Charles R. Pierce Southern Nuclear Regulatory Affairs Director Operating Company, Inc.

40 Inverness Center Parkway Post Office Box 1295 Birmingham , AL 35242 Tel 205.992.7872 Fax 205.992.7601 August 22, 2014 Docket Nos.: 50-321 NL-14-1245 50-366 U. S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington , D. C. 20555-0001 Edwin I. Hatch Nuclear Plant- Units 1 & 2 10 CFR 26.719(c) Report: False Negative Results for a Blind Performance Test Sample Ladies and Gentlemen:

In accordance with the requirements of 10 CFR 26.719(c), Southern Nuclear Operating Company hereby submits the enclosed Report.

Th is letter contains no NRC commitments. If you have any questions, please contact Greg Johnson at (912) 537-5874.

c(\fiw, Respectfully submitted, C. R. Pierce Regulatory Affairs Director CRP/jcm

Enclosure:

10 CFR 26.719(c) Report

U.S. Nuclear Regulatory Commission NL-1245 Page2 cc: Southern Nuclear Operating Company Mr. S. E. Kuczynski, Chairman, President & CEO Mr. D. G. Bost, Executive Vice President & Chief Nuclear Officer Mr. D. R. Vineyard, Vice President- Hatch Mr. B. L. lvey, Vice President- Regulatory Affairs Mr. T. E. Tynan, Vice President- Fleet Operations Mr. B. J. Adams, Vice President - Engineering Mr. G. L. Johnson, Regulatory Affairs Manager- Hatch RTYPE: CHA02.004 U. S. Nuclear Regulatorv Commission Mr. V. M. McCree, Regional Administrator Mr. R. E. Martin, NRR Senior Project Manager- Hatch Mr. D. H. Hardage, Senior Resident Inspector- Hatch

Edwin I. Hatch Nuclear Plant- Units 1 & 2 10 CFR 26.719(c) Report: False Negative Results for a Blind Performance Test Sample Enclosure NL-14-1245

Description of the Incident On July 4, 2014, at the request of Southern Nuclear Operating Company (SNC) Plant Hatch, Laboratory Corporation of America (LabCorp)- RTP conducted a urine drug screening on Specimen ID Number 0535257726 and reported a negative result. On July 7, 2014 the negative blind performance result was received by Plant Hatch Medical Services Supervisor. LabCorp was then contacted by Plant Hatch Medical Services and informed that Specimen ID 0535257726 was a blind quality control sample of phencyclidine (PCP) targeted at 37.5 ng/ml.

An investigation was consequently initiated by LabCorp to re-analyze the specimen and determine the reason for the inaccurate result. LabCorp is a Department of Health and Human Services (DHHS) certified laboratory.

Initial lab screenings for Specimen 0535257726 contained a presumptive positive result for PCP, negative results for any other drug, and normal for specimen validity testing. Confirmation testing for PCP was then scheduled for July 5, 2014. The specimen was aliquoted and extracted on July 6, 2014 and analyzed by Gas Chromatography/Mass Spectrometry. The confirmation result was 21 ng/ml and below the PCP cutoff of 25 ng/ml. The specimen was therefore reported to Plant Hatch as negative.

Based on the testing discrepancy, LabCorp repeated the extraction and analysis of PCP for Specimen 0535257726. The PCP confirmation result in the repeat test was 41 ng/ml and above the PCP cutoff of 25 ng/ml.

An investigation initiated by LabCorp ruled out all possible causes with the exception of a random isolated human performance error occurring during the pi petting of the specimen.

This is the most probable cause for the low quantity of PCP in the first confirmation batch. An independent consulting toxicologist was employed by SNC to oversee LabCorp's investigation and concurred with the conclusion of a pipetting error as the most probable cause of the testing discrepancy. The cause of the testing discrepancy was therefore attributed to an inappropriate amount of the sample being pipetted during the extraction process. The typical cause of this error is improper technique/use of the fixed volume pipette.

SNC obtained the services of an independent toxicology consultant who reviewed the data from the initial confirmation test and confirmed that the quality control specimens associated with the PCP batch were acceptable. Additionally, the recovery and chromatography were confirmed to be acceptable. Chain of custody and other documentation were all in accordance with the standard operating procedure.

Corrective Actions To avoid recurrence of a testing discrepancy, LabCorp extraction technologists have been retrained to carefully check the volume of urine aliquoted for the confirmation batch and to E-1

ensure consistent delivery of internal standards in accordance with the standard operating procedure.

In conjunction with the actions taken above, additional blind performance specimens will be submitted to LabCorp for the next two months to assess lab performance.

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