ML103210319

Submittal of Report of Testing Errors on Fitness for Duty Blind Samples by an HHS - Certified Laboratory

ML103210319
Person / Time
Site:	Indian Point
Issue date:	11/08/2010
From:	Pollock J E Entergy Nuclear Operations
To:	Document Control Desk, NRC/FSME, Office of Nuclear Reactor Regulation
References
NL-10-120
Download: ML103210319 (4)

Text

-Entergy Indian Point Energy Center 450 Broadway, GSB P.O. Box 249 Buchanan, N.Y. 10511-0249 Tel (914) 734-6700 J. E. Pollock Site Vice President NL-10-120 November 8, 2010 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Mail Stop O-P1-17 Washington, D.C. 20555-0001

SUBJECT:

Report of Testing Errors on Fitness For Duty Blind Samples by an HHS-Certified Laboratory Indian Point Unit Nos. 1, 2, and 3 Docket Nos. 50-03, 50-247, and 50-286 License Nos. DPR-5, DPR-26 and DPR-64

Dear Sir or Madam:

Pursuant to 10 CFR 26.719(c)(1), Entergy Nuclear Operations Inc. (Entergy) hereby provides, Enclosure 1, a report of an investigation into performance testing errors by an HHS-certified laboratory.

Two Fitness for Duty (FFD) blind Quality Assurance samples were incorrectly reported to the medical review officer (MRO) and Indian Point Energy Center (IPEC) as negative however one should have been reported as positive for cocaine and the other positive for opiates.There are no new commitments identified in this letter. Should you have any questions regarding this submittal, please contact Mr. Robert Walpole, Manager, Licensing at (914) 734-6710.Sincerely, JEP/sp cc: Mr. John P. Boska, Senior Project Manager, NRC NRR DORL Mr. William Dean, Regional Administrator, NRC Region I NRC Resident Inspector's Office, Indian Point 3 Mr. Paul Eddy, New York State. Public Service Commission

Enclosure:

1. Letter to Entergy dated October 13, 2010 Enclosure 1 to NL-10-120 LETTER TO ENTERGY DATED OCTOBER 13, 2010 ENTERGY NUCLEAR OPERATIONS, INC.INDIAN POINT NUCLEAR GENERATING UNIT NOS. 1, 2 AND 3 DOCKET NOS. 50-03, 50-247, AND 50-286 Quest N Diagnostics October 13, 2010 Kelly Pettus Indian Point/Entergy 450 Broadway Buchanan, NY 10511

Dear Ms. Pettus:

Two specimens, which were identified by you as blind urine quality control specimens, were received at Quest Diagnostics in Norristown, Pennsylvania on September 21, 2010 with the following identification and results: Specimen ID # 2409262 2409269 Laboratory ID 647879X 647865X Donor ID 292-89-4241 145-96-2821 Collection Date 9/20/2010 9/20/2010 Reported Negative Negative Report Date 9/21/2010 9/22/2010 Our laboratory was notified by you that neither specimen achieved the target result and we initiated an investigation.

Investigation:

The data from the initial (screening) test was reviewed.

The summary data from our chemistry analyzer was interpreted correctly.

We then reviewed the data directly from the analyzer and reviewed the bar-code numbers associated with the specimens.

When a portion of urine is tested, the portion ("aliquot")

is placed in a bar-coded tube. Test information and results are linked between the specimen and our computer system through this assigned bar-code.

Upon review of the bar-codes, we found that the bar-codes for these two sequentially tested specimens were reversed.

Consequently, the correct screening data was not captured.Confirmation testing by GC/MS was performed on these specimens based on the correct screening data. Specimen 2409262 confirmed positive for Cocaine metabolite (628 ng/mL) and Specimen 2409269 confirmed positive for Morphine (3999 ng/ml).Corrected reports were issued 10/4/2010 and 10/5/2010 respectively.

Corrective Action: Several corrective action steps were taken.1. This incident was reviewed with the appropriate staff.

2. Our Standard Operating Procedures were revised on October 1, 2010. This revision places additional focus on the review of bar code sequencing on screening loads that are prepared through the same manual aliquoting process used for these two samples.3. The bar-coded tubes have now been glued into the rack holders so that it will no longer be possible for staff to remove tubes. By permanently fixing these tubes in place, the possibility of getting tubes out of sequence is eliminated.

We regret that we failed to accurately identify these two blind quality control samples but are confident that the corrective actions taken should effectively eliminate a future recurrence of such an incident.Should have any additional questions or concerns, please call me at (877) 642-2216 x 4502.Sincerely, Susan Mills Operations Director, Forensic Toxicology