ML083170491: Difference between revisions

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#REDIRECT [[LR-N08-0247, Salem & Hope Creek Generating Stations, Report of HHS-Certified Laboratory Testing Error Investigation and Corrective Action]]
{{Adams
| number = ML083170491
| issue date = 10/30/2008
| title = Salem & Hope Creek Generating Stations, Report of HHS-Certified Laboratory Testing Error Investigation and Corrective Action
| author name = Fricker C
| author affiliation = PSEG Nuclear, LLC
| addressee name =
| addressee affiliation = NRC/Document Control Desk, NRC/NRR
| docket = 05000272, 05000311, 05000354
| license number = DPR-070, DPR-075, NPF-057
| contact person =
| case reference number = LR-N08-0247
| document type = Letter, Report, Miscellaneous
| page count = 5
}}
 
=Text=
{{#Wiki_filter:PSEG Nuclear LLC P.O. Box 236, Hancocks Bridge, New Jersey 08038-0236 0 mrSEG Nuclear LLC OCT 3 O02008 10 CFR26.719 LR-N08-0247 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 SALEM AND HOPE CREEK GENERATING STATIONS FACILITY OPERATING LICENSE NOS. DPR-70, DPR-75 AND NPF-57 DOCKET NOS. 50-272, 50-311 AND 50-354
 
==Subject:==
REPORT OF HHS-CERTIFIED LABORATORY TESTING ERROR INVESTIGATION AND CORRECTIVE ACTION PSEG Nuclear LLC hereby forwards the attached HHS Laboratory (DRUGSCAN)
Report of Investigation and Corrective Action, dated October 3, 2008, in accordance with the requirements of 1OCFR26.719 (c) 1. This investigation was conducted because of a false negative result on a blind proficiency specimen, which was generated and reported to our Medical Review Officer (MRO).No Regulatory commitments are contained in this correspondence.
Should you have any questions concerning this letter, please contact Philip J.Duca at (856) 339-1640.Sincere arl ri er Vice President
-Operations Support
 
==Attachment:==
 
DRUGSCAN -Report of Investigation and Corrective Action 95-2168 REV. 7/99 Document Control Desk LR-N08-0247 Page 2 C Mr. S. Collins, Administrator
-Region I U. S. Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406 Mr. R. Ennis, Project Manager -Hope Creek U. S. Nuclear Regulatory Commission Mail Stop 08B3 Washington, DC 20555-0001 USNRC Senior Resident Inspector
-Hope Creek (X24)USNRC Senior Resident Inspector
-Salem (X24)Mr. P. Mulligan, Manager IV Bureau of Nuclear Engineering PO Box 415 Trenton, New Jersey 08625 Cecilia Homan -(N44)Tim Devik, Hope Creek Commitment Coordinator (H02)Howard Berrick, Salem Commitment Coordinator (X-25)Lee Marabella, Corporate Commitment Coordinator (N-21)
Document Control Desk LR-N08-0247 Attachment Page 1 Attachment DRUGSCAN Report of Investigation and Corrective Action (3 Pages including this page)
Document -Control -Desk LR-N08-0247 Attachment Page 2 D R:U GS. C ;,CA N W:ý'Z.-Medical and Forensic oxicology Services -.-*Phoneo215.674.9310 Fax2l56755353 1119 Mearns Road, P0 Boy 2969 Warminster, PA 1 8974-0097 V Report of Investigato ad CorrecieAto
: 1. Problem: On 12 SEP 2008, the.laboratory:eceived a specimen from Account:.'
'-"Number X0908 which is identified by the laboratory accession number 08121478...
.: The speimenwas reported .negatiye .to the client'.s fO. wha Minfact cthis was: aBlindProficiency specimen with.the.expeted result: Pos6tive-cPC.(,: P.hencychine).
qThe instr ent rcading. for 08121478.ws 24.4 ng/x.iiL witha.reporti7g positive cdok nJmL iefo7e a sale negatve result was generated and repoted to teMR.'.2. Investigation:
Upon notification'of the. problem, the laboratory re-analyzed specimen 08121478 onthe or.ignteent, an O1ympus5221.
The reanalysis was Positive:
PCP. .The Olym~pus 5221I was then taken off line adutfsevc.A:
mehncland sevceispcio f the instrument wascodce.Uo iasml of te asStarion apparatus, asalcck of a ahioze line was.dtce.Ti
.condition culd result in a small, residual amount of de ewater remi g in,.-a cuvette. This residual rionized waterould actas adiluent withe effectthat the true concentration of an analyte could be lowered.The physica configurationi of the Olympus 521is such that temlucinn Wash station nozzle would only effectthe cu*4 ett-et sed. for a particua assay. " ..this caePC.3.'Corrective Action: :Al specme for X0908 ta 0r tested.on.theOlympus
:5221 for PCP were re-reviewed back to the last- aceptable PCP blind roficieny specimen forsk0908.
With thceexception of specimen 08 121478, there were no specimens with a PCP potential false negative results exist..:.:::=.:.:.
..In :d4itpon, aljl seimens for X0908 are now tested onan ymp 700 for' "arhuaaa nmetabolites, cocaine metabolite, aphet e phenccidie, creatinine, pH, and oxidants.D:: :g.c.an, Inc.. www.druqgscan.co.
NOTE: Account Number X0908 is PSEG Nuclear, LLC Document Control Desk LR-N08-0247 Attachment Page 3 4.
 
== Conclusion:==
 
The Problem of specimen 08121478 was the result of a random, mechanical, instrument-error and the Quality Control Program of X0908 in blind-proficiency.
testing has successfully performed the funtion. of identifying
.-..-. -..- ?..pnt.endpm~blemseforn.effe1ing.resu~ts.-fntac don`nr;specimens..
_Robert G. Tuay, M.S...-Associate Laboratory Director 03 OCT 2008.:.. [.. "" ...". ..DIRUGSC kN°}}

Revision as of 08:37, 19 March 2019

Salem & Hope Creek Generating Stations, Report of HHS-Certified Laboratory Testing Error Investigation and Corrective Action
ML083170491
Person / Time
Site: Salem, Hope Creek  PSEG icon.png
Issue date: 10/30/2008
From: Fricker C
Public Service Enterprise Group
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
LR-N08-0247
Download: ML083170491 (5)


Text

PSEG Nuclear LLC P.O. Box 236, Hancocks Bridge, New Jersey 08038-0236 0 mrSEG Nuclear LLC OCT 3 O02008 10 CFR26.719 LR-N08-0247 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 SALEM AND HOPE CREEK GENERATING STATIONS FACILITY OPERATING LICENSE NOS. DPR-70, DPR-75 AND NPF-57 DOCKET NOS. 50-272, 50-311 AND 50-354

Subject:

REPORT OF HHS-CERTIFIED LABORATORY TESTING ERROR INVESTIGATION AND CORRECTIVE ACTION PSEG Nuclear LLC hereby forwards the attached HHS Laboratory (DRUGSCAN)

Report of Investigation and Corrective Action, dated October 3, 2008, in accordance with the requirements of 1OCFR26.719 (c) 1. This investigation was conducted because of a false negative result on a blind proficiency specimen, which was generated and reported to our Medical Review Officer (MRO).No Regulatory commitments are contained in this correspondence.

Should you have any questions concerning this letter, please contact Philip J.Duca at (856) 339-1640.Sincere arl ri er Vice President

-Operations Support

Attachment:

DRUGSCAN -Report of Investigation and Corrective Action 95-2168 REV. 7/99 Document Control Desk LR-N08-0247 Page 2 C Mr. S. Collins, Administrator

-Region I U. S. Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406 Mr. R. Ennis, Project Manager -Hope Creek U. S. Nuclear Regulatory Commission Mail Stop 08B3 Washington, DC 20555-0001 USNRC Senior Resident Inspector

-Hope Creek (X24)USNRC Senior Resident Inspector

-Salem (X24)Mr. P. Mulligan, Manager IV Bureau of Nuclear Engineering PO Box 415 Trenton, New Jersey 08625 Cecilia Homan -(N44)Tim Devik, Hope Creek Commitment Coordinator (H02)Howard Berrick, Salem Commitment Coordinator (X-25)Lee Marabella, Corporate Commitment Coordinator (N-21)

Document Control Desk LR-N08-0247 Attachment Page 1 Attachment DRUGSCAN Report of Investigation and Corrective Action (3 Pages including this page)

Document -Control -Desk LR-N08-0247 Attachment Page 2 D R:U GS. C ;,CA N W:ý'Z.-Medical and Forensic oxicology Services -.-*Phoneo215.674.9310 Fax2l56755353 1119 Mearns Road, P0 Boy 2969 Warminster, PA 1 8974-0097 V Report of Investigato ad CorrecieAto

1. Problem: On 12 SEP 2008, the.laboratory:eceived a specimen from Account:.'

'-"Number X0908 which is identified by the laboratory accession number 08121478...

.: The speimenwas reported .negatiye .to the client'.s fO. wha Minfact cthis was: aBlindProficiency specimen with.the.expeted result: Pos6tive-cPC.(,: P.hencychine).

qThe instr ent rcading. for 08121478.ws 24.4 ng/x.iiL witha.reporti7g positive cdok nJmL iefo7e a sale negatve result was generated and repoted to teMR.'.2. Investigation:

Upon notification'of the. problem, the laboratory re-analyzed specimen 08121478 onthe or.ignteent, an O1ympus5221.

The reanalysis was Positive:

PCP. .The Olym~pus 5221I was then taken off line adutfsevc.A:

mehncland sevceispcio f the instrument wascodce.Uo iasml of te asStarion apparatus, asalcck of a ahioze line was.dtce.Ti

.condition culd result in a small, residual amount of de ewater remi g in,.-a cuvette. This residual rionized waterould actas adiluent withe effectthat the true concentration of an analyte could be lowered.The physica configurationi of the Olympus 521is such that temlucinn Wash station nozzle would only effectthe cu*4 ett-et sed. for a particua assay. " ..this caePC.3.'Corrective Action: :Al specme for X0908 ta 0r tested.on.theOlympus

5221 for PCP were re-reviewed back to the last- aceptable PCP blind roficieny specimen forsk0908.

With thceexception of specimen 08 121478, there were no specimens with a PCP potential false negative results exist..:.:::=.:.:.

..In :d4itpon, aljl seimens for X0908 are now tested onan ymp 700 for' "arhuaaa nmetabolites, cocaine metabolite, aphet e phenccidie, creatinine, pH, and oxidants.D:: :g.c.an, Inc.. www.druqgscan.co.

NOTE: Account Number X0908 is PSEG Nuclear, LLC Document Control Desk LR-N08-0247 Attachment Page 3 4.

Conclusion:

The Problem of specimen 08121478 was the result of a random, mechanical, instrument-error and the Quality Control Program of X0908 in blind-proficiency.

testing has successfully performed the funtion. of identifying

.-..-. -..- ?..pnt.endpm~blemseforn.effe1ing.resu~ts.-fntac don`nr;specimens..

_Robert G. Tuay, M.S...-Associate Laboratory Director 03 OCT 2008.:.. [.. "" ...". ..DIRUGSC kN°