ULNRC-05678, Lab Test Results

Lab Test Results

ML100470732
Person / Time
Site:	Callaway
Issue date:	02/09/2010
From:	Graessle L AmerenUE, Union Electric Co
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
ULNRC-05678
Download: ML100470732 (9)

Text

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wAmeren UE AmerenUE Cal/away Plant February 9, 2010 ULNRC-05678 u.s. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 Ladies and Gentlemen:

1 OCFR26. 719( C)

DOCKET NUMBER 50-483 CALLA WAY PLANT UNIT 1 UNION ELECTRIC CO.

FACILITY OPERATING LICENSE NPF-30 Lab Test Results PO Box 620 Fulton, MO 65251 On 1119/2010, the University of Missouri Toxicology and Drug Monitoring Laboratory discovered that they had erroneously reported a specimen as positive for amphetamines under 10CFR26.163 even though the specimen did not meet the criteria for a dilute specimen. The laboratory is a Department of Health and Human Services (DHHS) laboratory.

In accordance with 10CFR26.719(c), enclosed is the documentation of investigative findings and the corrective actions taken by the University of Missouri, Toxicology and Drug Monitoring Laboratory. Please contact Anna Lee at 573/676-4435 ifany additional action is needed as a result of this information.

This letter does not contain new commitments.

Sincerely, ct-;/Jt~

Luke H. Graessle Director, Operations Support CSP/nls Enclosures a subsidiary of Ameren Corporation

ULNRC... 05678 February 9,2010 Page 2 cc:

Mr. Elmo E. Collins, Jr.

Regional Administrator U. S. Nuclear Regulatory Commission Region IV 612 E. Lamar Blvd., Suite 400 Arlington, TX 76011-4125 Senior Resident Inspector Callaway Resident Office U. S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. Mohan C. Thadani (2 copies)

Senior Project Manager, Callaway Plant Office of Nuclear Reactor Regulation U. S. Nuclear Regulatory Commission Mail Stop 0-8G 14 Washington, DC 20555-2738

ULNRC.. 05678 February 9,2010 Page 3 Index and send hardcopy to QA File A160.0761 Hardcopy:

Certrec Corporation 4200 South Hulen, Suite 422 Fort Worth, TX 76109 (Cet1rec receives ALL attachments as long as they are non-safeguards and may be publicly disclosed. )

Electronic distribution for the following can be made via Other Situations ULNRe Distribution:

A. C. Heflin F. M. Diya L. S. Sandbothe C. D. Reasoner ill S. A. Maglio E. H. Bradley S. L. Gallagher T. L. Woodward (NSRB)

T. B. Elwood Ms. Diane M. Hooper (WCNDC)

Mr. Dennis Buschbaum (Luminant Power)

Mr. Ron Barnes (APS)

Mr. Tom Baldwin (PG&E)

Mr. Wayne Harrison (STPNOC)

Mr. John O'Neill (Pillsbury Winthrop Shaw Pittman LLP)

Missouri Public Service Commission

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VAmeren UE Callaway Plant February 4, 2010 Anna Lee Supervisor Access Authorization / Fitness for Duty AmerenUE Callaway Plant P.O. Box 620 Fulton, MO 65251 RE: Investigation of Toxicology False Positive Report Sample ID TIl 0272 Employee ID_

PO Box 620 Fulton, MO 65251 I took part in the discussion with Toxicology Scientific Director Paul Carey regarding the circumstances of the false positive reporting of the above specimen. Having received and reviewed the investigative report of January 22, 2010 submitted by Toxicology, I am in agreement with their Corrective Action Plan. This reporting error was detected prior to notification of the involved enlployee and therefore no action was taken in regard to the employee.

As MRO, I am satisfied that the appropriate remedial action has been undertaken.

Sincerely,.

II /

1z{~/i~~**'

Willianl P. Cravens, MD Ameren UE Medical Review Officer 573-676-4301 a subsidiary of Ameren Corporation

'ffl University I IT Hpspitals & Clinics University of MISsouri Health Care January 22,2010 Dr. William Cravens Medical Review Office Fitness for Duty Program AmerenUE - Callaway Plant P.O. Box 620 Fulton, Missouri 65251

Dear Dr. Cravens:

Toxicology and Drug Monitoring Laboratory 301 Business Loop 70 West Suite 208 Columbia, MO 65203 PHONE 573-882-1273 FAX 573-884-4917 On January 19, 2010, the labor8to~ discovered thatit had erroneously reported the drug testing results of an AmerenUE sample identified with employee ID #_ Specimen 10

1. T110272. On the previous day, the results were transmitted as positive for amphetamine. This report was in error - the 'results should have been reported as negative. Since the determination of this error was made in conjunction with and with the.

assistance of AmerenUE staff (Aaron Enloe), the licensee was notified of the error contemporaneously with its discovery. Please find below our investigation into this error and a description of our corrective actions.

Investigation of the False Positive Report:

The AmerenUE sample with employee 10 #..

Specimen ID # T11 0272 was collected on January 14,2010 and was delivered to the laboratory via courier the same day. Also on January 14, this sample was received, accessioned (accession number 10-014-002608) and tested by the laboratory using approved screening procedures.

While the initial screening results for drugs all yielded negative results, the urine creatinine concentration of this sample was determined to be 15.7 mg/dL and the sample was recognized as being "presumptively" dilute - pending specific gravity testing. On that particular daY,the laboratory was also completing the testing of a batch of NLCP proficiency test samples (Occasion #93) and the specific gravity testing on the AmerenUE sample was delayed for several hours.

While the sample tested negative for drugs by the initial screening method. the NRC has a special rule (unlike other federally-regulated testing) that requires confirmation testing if the sample is both dilute and has an immunoassay response that is equal to or greater than 50 percent of the cutoff. This sample had an immunoassay response that was equal to or greater than 50 percent of the cutoff for amphetamine.

This rule, contained in 10 CFR Part 26 Fitness for Duty Programs; Final Rule -March 2008 reads as follows:

AN EQUAL OPPORTUNITY/ADA INSTITUTION Donor's personal information was redacted on this letter.

Dr. William Cravens January 22. 2010 Page 2

§ 26~163 (a) (2) (i-iii)

(i) If initial validity testing indicates that a specimen is dilute, the HHS-certified laboratory shall compare the responses of the dilute specimen to the cutoff calibrator in each of the drug classes; (ii) If any response is equal to or greater than 50 percent of the cutoff, the HHS-certified laboratory shall conduct confirmatory testing of the specimen down to the LOD for those drugs and/

or drug metabolites; and (iii) The laboratory shall report the numerical values obtained from this special analysis to the MRO.

Based upon the criteria above and given that the sample in question had an immunoassay response that was equal to or greater than 50 percent of the cutoff for amphetamine, the sample was inadvertently transferred to the confirmation testing area before the specific gravity determination had been completed (data necessary to establish whether the sample was in fact dilute).:

The specific gravity determination was completed later that day (January 14) and the results were recorded on the primary worksheet as 1.0043-indicating that the sample did not meet the NRC criteria for a dilute specimen (creatinine less than 20mg/dL AND a specific gravity of less than 1.0030). The fact that the sample was not dilute went undetected by the analysts/reviewers and the sample proceeded to confirmation.

On Friday, January 15, 2010, the sample was analyzed by GC/MS and the confirmation results were certified on that day. The GC/MS results indicated an amphetamine concentration of 661 ng/mL - which was well above the laboratory's LOOfor the confirmation amphetamine assay. Therefore, the sample was determined to be a confirmed positive.

The following Monday, January 18, the drug testing results on AmerenUE employee 10 #

Specimen I D # T11 0272, LAN 10-014-002608 were certified and the erroneous report indicating a positive amphetamine was transmitted to the AmerenUE - Callaway Plant The certifying scientist did not catch the fact that the sample was not dilute during final data review. The correct certified result should have been reported as negative.

It was not until the following day that the error was discovered.

Dr. William Cravens January 22, 2010 Page 3 Evaluation of the False Positive Report Investigation:

First, the laboratory acknowledges this mistake. The error should not have occurred.

Our investigation focused on determining the cause(s) of the error in an effort to establish remedial actions to preclude reoccurrence.

It is evident that the certifying scientist who released the results did not have a sufficient understanding of § 26.163 (a) (2) (i-iii) in.order to correctly interpret the data.

Our SOP states the following:

Prior to reporting, the final certifying scientist must reviewal/ data for a specimen and document that the reviewed results are CONSt STENT (i. e.,

initial and confirmatory drug test results; screening, initial and confirmatory specimen validity test results; aI/ GCIMS data for the specimen including failed data and data from failed batches).

While it is unclear whether strict adherence to this policy statement would have prevented this error (given the newness of § 26.163 (a) (2) (i-iii) and our unfamiliarity with this provision), the SOP provid,es appropriate guidance that should have averted the transmission of an erroneous report.

Our investigation indicates that this mistake was a procedural reporting error - not an analytical error. The testing was accurate (albeit the GC/MS test for amphetamines was unnecessarily conducted) and the analytical results were correct, however, the findings obtained by the testing were incorrectly handled and reported in a manner that was inconsistent with NRC policy. (Note: It was determined after the fact that the donor of this sample was taking the prescription medication Adderall.)

In reviewing the circumstances of this. error, it is clear thatthe laboratory failed to link the results from the screening tests (including the specific gravity determination) with the results from confirmatory testing. Normally, specific gravity and other specimen validity testing is performed concurrently with the testing for drugs. This process results in the data being connected at the completion of the initial testing phase - where the determination of dilute, invalid, adulterated and substituted is made by the initial reviewer. However, in this case, the specific gravity testing was delayed, the normal pattern of review was interrupted and the critical linkage between the two results (creatinine and specific gravity) failed to be completed appropriately.

Furthe'r, our investigation has concluded that there are no systematic faults that would require the re-analysis of other "positive" samples previously reported to this licensee.

This particular sample represents the very first occasion that necessitated the laboratory to consider confirming a sample that met the criteria outlined in § 26.163 (a) (2) (i~jii).

Dr. William Cravens January 22, 2010 Page 4 In summary, the identified causes of this error were determined to be:

1. Failure on the part of a certifying scientist to completely understand and thereby accurately interpret the provisions of § 26.163 (a) (2) (i*iii).

2. The premature routing of the sample to the confirmation area prior to the completion and review of all of thE! initial screening steps (including specimen validity tests).

3. Failure on the part of (I certifying scientist to appropriately evaluate the results/data from all laboratory analyses at the final review stage to ensure consistency and compliance with all applicable reporting rules.

On an encouraging note, the error was detected in a timely fashion via internal laboratory QA controls (and with the assistance of an Ameren-Callaway employee) within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the original report transmission. This rapid response enabled the Ameren-Callaway MRO tQi avert any untoward consequences to the sample donor.

Corrective Action Plan:

After discussions with key Fitness for Duty Program staff, an amended result report on AmerenUE employee 10 #..

Specimen 10# T110272, LAN 10-014~002608 was issued by the laboratory on January 20 and transmitted to the AmerenUE - Callaway Plant.

In addition the laboratory has taken the following corrective actions:

1. On January21, 2010, a meeting was held with the certifying scientists of the laboratory and the provisions of § 26.163 (a) (2) (i-iii) were reviewed in detail. These provisions have also been posted in the certification area.

2. The result reporting format for AmerenUE samples has been modified. In the future, sample reporting that meets the criteria outlined in § 26.163 (a) (2) (i-iii) will include the results of creatinine and specific gravity testing. Had this reporting practice been in place on January 18, it would have been obvious to the certifying scientist that the result being reported was not appropriate - due to the fact that the sample did not meet the dilute criteria.

3. AI/laboratory staff have beencounseled not to relocate samples to the confirmation area until all of the initial screening steps (including specimen validity testing) have been completed and rE~viewed.

Dr. William Cravens January 22, 2010 Page 5 The laboratory deeply regrets this error and counts itself fortunate that the donor was not negatively impacted. I appreciate the opportunity to provide you with the results of our investigation and trust that our remedial actions meet with your approval. If you have any questions or if I can provide you with additional information, please do not hesitate to contact me.

Respectfully yours, 0?<t2; Paul L. Cary, M.S.

Responsible Person/Scientific Director Toxicology and Drug Monitoring Laboratory PLC:mac TOTAL P.006