ML12017A090

Report of Testing Errors

ML12017A090
Person / Time
Site:	Monticello, Prairie Island
Issue date:	01/13/2012
From:	Patricia Anderson Xcel Energy, Northern States Power Co
To:	Office of Nuclear Reactor Regulation, Document Control Desk
References
L-XE-11-016
Download: ML12017A090 (7)

Text

Xcel Energy January 13, 2012 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Prairie Island Nuclear Generating Plant, Units 1 and 2 Dockets 50-282 and 50-306 Renewed License Nos. DPR-42 and DPR-60 Report of Testing Errors 414 Nicollet Mall-MP4 Minneapolis, MN 55401 L-XE-11-016 10 CFR 26.719 Monticello Nuclear Generating Plant Docket 50-263 Renewed License No. DPR-22 Pursuant to 10 CFR 26.719(c)(1), Northern States Power Company, a Minnesota corporation, doing business as Xcel Energy (hereafter "NSPM"), submits a report of testing errors that adversely reflect the integrity of the fitness for duty (FFD) testing process and the corrective actions taken. The enclosure to this letter provides the required information which applies to NSPM and its Prairie Island Nuclear Generating Plant (PINGP) and Monticello Nuclear Generating Plant (MNGP).

The enclosed report concluded that technologists who perform the affected testing required additional training. On December 23,2011, confirmation from vendor that all technologists performed in accordance with standard operating procedures, and have been deemed competent to perform specific gravity testing. NSPM Corrective Action Program has been updated with the validation from the vendor.

If there are questions or if additional information is needed, please contact Mr. Dale Vincent, P.E., at 651-388-1121.

Summary of Commitments This letter conta' no new commitments and no revisions to existing commitments 12 Paula K. Anderson Director Nuclear Licensing and Regulatory Affairs Northern States Power Company - Minnesota Enclosures (1)

(copy list on page 2)

Document Control Desk Page 2 cc:

Administrator, Region III, USNRC Project Manager, PINGP, USNRC Resident Inspector, PINGP, USNRC Project Manager, MNGP, USNRC Resident Inspector, MNGP, USNRC

ENCLOSURE Unsatisfactory Blind Specimen Test Result from Occupational Medicine Consultants, Ltd.

4 pages follow

Thomas C, Jetzer, MD, MPH, FACOEM Richard R. Hlrt, MD Gerald Peterson, MD, MPH OEe ~ 0 2011 OCCUPATIONAL MEDICINE CONSULTANTS, lTD.

Unsatisfactory Blind Specimen Test Result:

6515 Barrie Road Edina, Minnesota 55435 (952) 920-5663 FAX (952) 924-1659 Expected blind specimen dilute result not received. On October 4th, 2011 a blind specimen was sent, per 10 CFR subpart 26.168, to our contracted drug testing facility. The specific specimen was a dilute blind specimen that was sent as part of the quality assurance plan, per FP-S-FFO-

01. This specific specimen was within the parameters outlined in 10 CFR subpart 26.168 as a dilute specimen blind performance test and was certified at a creatinine concentration 16.5 mg/dL with a specific gravity of 1.002.

On October 5, 2011, the results of actual test, Bottle A, came back with a creatinine concentration of 13.6 mg/dL and a specific gravity of 1.0034. The lab did not report as a dilute specimen because their results for specific gravity came in higher than the cutoff of 1.0030, as defined in 10 CFR subpart 26.161.'

Investigation Details:

Based on the discrepancy and per FP-S-FFO-01, the Medical Review Officer (MRO) initiated an investigation to determine where the variability existed and to identify and implement corrective actions.

Blind Specimen Suitability To determine whether the blind specimen used met manufacturer specifications, a secure sample of the specimen, Bottle B, was sent to an independent laboratory, Quest Diagnostics, for testing. This was done in an effort to determine if the discrepancy could be traced back to Elsohly Laboratories, the creator of the sample, or to Medtox, the laboratory that did the original testing on October 4' 2011. The result from Quest Diagnostics came back with a specific gravity 1.002 and a creatinine of 14.6.

This result was in line with the original specifications of the sample and directed the investigation back to Medtox.

Medtox was then asked to reassess and reanalyze the specimen, Bottle A. the second Medtox test resulted in expected values of 1.0021 for a specific gravity and a creatinine of 12.7. The result of this second test was in line with the original specifications and narrowed the deviation source to the original sampling process on October 4, 2011 Parallel to the blind specimen re-testing, Elsohly Laboratories was contacted to ascertain what their acceptable statistical deviation would be on the original

sample. This was done to determine if the.0014 deviation in specific gravity was an allowable deviation to their specifications. Elsholy Laboratories came back with a

.0001 difference as their confidence limit on this created sample. This validated that the original deviation was not within the allowable limits as specified by the creator of the sample.

Medtox Specimen Processing The NSPM MRO directed the Director of Forensic Laboratories for Medtox to to review and investigate the sample testing and process done on October 4,2011.

Medtox reviewed the initial testing data, calibration and quality control data, instrument precision and allowable error, specimen evaporation potential, human performance, variability and specimen handling. Medtox, in a letter dated December 2, 2011 concluded that the most likely cause for the discrepancy was variable sample handling/testing technique by the technologist.

Technologist failure to follow the standard operating procedures and/or testing technique can impact results.

For example, insufficient specimen volume or asymmetrical coverage of the prism can bias the specific gravity measurement. While there is no direct evidence that this occurred during the testing of specimen number

N7868370, it is possible that human error or viability is a factor in the discrepant results.

Conclusion/Corrective Actions Based on the investigation, supporting analysis and reviews from all parties involved, the specific gravity deviation which led to a non-dilute testing result was due to sample handling/testing technique by the technologist working the case on October 4, 2011. Corrective action 01307390-03 has been initiated to track Medtox's completion of appropriate specimen handling and testing procedure reviews with all technologists who perform testing using J57 refractometers and competency assessments to ensure accurate results are generated from a group of blind specimens.

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