ML18100A752

Submits Documentation of Unsatisfactory Performance Test Result Conducted at Util Secondary Health & Human Services- Certified Lab.Record of Investigative Findings & Corrective Action Taken by Lab Encl

ML18100A752
Person / Time
Site:	Salem, Hope Creek, 05000345
Issue date:	12/01/1993
From:	Hagan J Public Service Enterprise Group
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NLR-N93188, NUDOCS 9312130412
Download: ML18100A752 (7)

Text

.e Public Service Electric and Gas Company Joseph J. Hagan Public Service Electric and Gas Company P.O. Box 236, Hancocks Bridge, NJ 08038 609-339-1200 Vice President - Nuclear Operations DEC 0 i 1993 NLR-N93188 U.S. Nuclear Regulatory Commission Document Control Desk Washington, DC 20555 Gentlemen:

FITNESS FOR DUTY BLIND PERFORMANCE TEST REPORT SALEM AND HOPE CREEK GENERATING STATIONS DOCKET NOS. 50-272, 50-311, AND 50-354 This letter is to submit documentation of an unsatisfactory performance test result conducted at Public Service Electric and Gas's (PSE&G) secondary Health and Human Services (HHS)-certified laboratory. This notification is being made pursuant to the requirements of 10CFR26 Appendix A, Section 2.S(e) (4).

On October 6, 1993, drug-spiked specimens were sent to two PSE&G contracted laboratories in accordance with the Quality Control blind performance testing requirements. One of these laboratories incorrectly reported concentrations below PSE&G's established threshold (cut-off). PSE&G has conducted an investigation of this erroneous negative report and found that the sample was diluted by the laboratory due to the high drug concentration of the specimen. The diluted sample results were then compared to the concentration cut-off value without accounting for the dilution factor. As a result, an incorrect negative report was submitted by the laboratory to PSE&G.

Enclosed is the record of the investigative findings and the corrective action taken by the laboratory. Should you have any questions on the information provided, please contact s. Mannon of our Licensing staff (609-339-1129).

Sincerely,

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• 1 PDR. ADOCK

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DECO 1 1993 Document Control Desk - 2 -

NLR-N93188 Enclosure (1)

Affidavit C Mr. T. T. Martin, Administrator - Region I

u. s. Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406 Mr. J. C. Stone, Licensing Project Manager U. S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852 Mr. s. Dembek, Licensing Project Manager U. S. Nuclear Regulatory Commission One White Flint North 11555 Rockville Pike Rockville, MD 20852 Mr. c. S. Marschall (S09)

USNRC Senior Resident Inspector Mr. K. Tosch, Manager, IV NJ Department of Environmental Protection Division of Environmental Quality Bureau of Nuclear Engineering CN 415 Trenton, NJ 08625

REF: NLR-N93188 STATE OF NEW JERSEY

) SS.

COUNTY OF SALEM )

J. J. Hagan, being duly sworn according to law deposes and says:

I am Vice President - Nuclear Engineering of Public Service Electric and Gas Company, and as such, I find the matters set forth in the above referenced letter, concerning the Salem Nos.

Generating Station and the Hope Creek Generating Station, are true to the best of my knowledge, information and belief.

Subscribed. and Sworn t~ before me thi~ / f)f-;__ day of L'£f'im1 bg_;,__ *, 1993

,d{mJ~ff=YJAfuv~

• Notary Publ~New Jersey KIMBERLY JO BROWN NOTARY PUBLIC OF NEW JERSEY My Commission expires on My Gemmissioa Expires April 21, 1998

l I

PSE&G MEDICAL DEPARTMENT -.NUCLEAR URINE DRUG TESTING PROGRAM DISCREPANCY' RECONCILIATION/RESOLUTION' FORM

1. Report No. q3_ 001- B Incident: [_] Patient Test Results Priority 2.. r ] Negative QC Test Results Issue Date /0-1'-f-q3 [.>i] Blind Sample QC Test Response Due /0-~B-Cf3 [_] Other 2.

Description:

"Blind S.0...Mple. ide.niri'ed as l<e.i't--h s. Pa.rham 4-9Cf- L/-0-4-D43 wa.s sobmitte.d to"botfJ N11)A re.re.renl!e..

A riall.(S j 5 £roru t-he. ve.,ndor .StQi:-e d the s am pie C'oot:a. tned ltn,p. I q 3 / n~lmL Qnd me.'t-h '7"-DOO n~lmL. p DLf+ repai-'ted -&he sampi a.s nega:t:ive.. ~cc1:s.sioN 7fl:..1Y..l'J.7co

3. Technical Evaluation: I ha \le r evre....ue d t~ e. re ~eo1'se. t o o ui- d' .scr-c.pQ.ney noti~\co.:tHm £~on"\ Ha.smul~h ~a..h,"!t.'[) oF POLA do..te.d Oct:o\:ie.c .2.S, 1ciqo.

Mr ~o....'r\ ha.s pro11*1de.d C..hait\ o~ Custocl.I..\ doe1.1111e.nt-Q."tio(\ 1 Sc.re.e.,.,no ,..,,i:;,,..MJU"7°?))1 as W'et(.

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~s tV.e 6-cms re.tu1-r-s.T'1e '}ua.nto..trfe cc:,eo1'"t:.§.how.s a,.re.a.d.*n.fiof: Bi</- For ~-Anieh~t:.a.mine.

(lx\d 31olo n%1nl fol" Me.:\*\-.O...MJtlne.i:.o..*m~~. --rhese ces.u.,l't"S wo..ild be be.low our _soontilmL..

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Organization: P'S e~c.

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4. Final Disposition:

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J j s Sole.1'1 (:or purpose of o.pp-ea. /

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~ i .

PDIA.

October 25, 1993 Ms. Mary T. Samuels PSE&G Medical Department Hancocks Bridge, NJ 08034

Dear Mary,

This letter is a response to the discrepancy notification received by PDLA on 10/21/93. A PSE&G specimen (accession #1474700) was received by PDLA on 10/12/93 and was screened on the same day by enzyme immunoassay and determined to be a presumptive positive for amphetamines. A GC/MS confirmation analysis was performed on 10/13/93 and resulted in a positive confirmation for cl-amphetamine at a concentration

'of 1,870 ng/ml and methamphetamine at a concentration of 1,830 ng/ml. Please review the attached copies of technical logs, worksheets and chromatographic reports.

Unfortunately, the result described above was reported to PSE&G as negative rather than positive. After extensive review, I can only conclude that this erroneous report was the result of A) a human error in result entry or B) a computer database failure.

Coincidentally, at that time, we had a rare hardware failure in our computer system called a head dish assembly crash. This incident resulted in database degradation that otherwise was fully restored without a trace of any problems. I believe that it is more likely that your erroneous report is the result of a computer database degradation.

There is no excusing the erroneous report, however, no matter what its source. I apologize for our clerical failure and will demonstrate to you that changes have been implemented to further reduce the possibility of such a failure.

Mary, listed below are the corrective action that I have implemented:

1. A computer routine was added to question certifying scientists "have you double checked" and the scientist will have to type "yes" or "no" before a result is released into the data system.

Executive Headquarters 100 Corporate Court South Plainfield, New Jersey 07080 1-908-769-8500 1-800-237-PDLA

• FAX 1-908-769-2444

Page2

2. "Certifying Scientist Review Report" will be required to print on an in-house printer and be reviewed by a certifying scientist and compared to worksheet results before being authorized to print at PSE&G.

3. An audit trail program will monitor all activity and entries to the PSE&G account.

I hope that these improvements and our future performance help you to regain your confidence in PDLA. We appreciate your business and will be pleased to respond to any suggestions that you may have. Please call be at (908) 769-8500 if I can be of any further assistance and have a nice day.

Sincerely,

~~~-

Hasmukh Shah, BLD Responsible Person Forensic Toxicology Director HS/cdg Enclosure