ML063050535
| ML063050535 | |
| Person / Time | |
|---|---|
| Site: | Oconee, Mcguire, Catawba, McGuire  |
| Issue date: | 10/26/2006 |
| From: | Jamil D Duke Energy Corp |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| Download: ML063050535 (7) | |
Text
mDuke E Energy DHIAA M. JAMIL Group VP, Nuclear Support Nuclear Generation 526 South Church St.
Charlotte, NC 28202 Mailing Address:
EC07H / PO Box 1006 Charlotte, NC 28201-1006 704 382 6191 704 382 6056 fax dmjamil@duke-energy. com October 26, 2006 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001
Subject:
Duke Power Company LLC d/b/a Duke Energy Carolinas, LLC Oconee Nuclear Station, Units 1, 2, and 3 Docket Nos. 50-269, 50-270, 50-287 McGuire Nuclear Station, Units 1 and 2 Docket Nos. 50-369, 50-370 Catawba Nuclear Station, Units 1 and 2 Docket Nos. 50-413, 50-414 Report of Unsatisfactory Laboratory Performance Fitness-For-Duty Program Pursuant to 10 CFR 26, Appendix A, 2.8(e)(4), attached is a report on an incident involving an unsatisfactory performance test result.
Should there be any questions concerning this report, please contact R. L. Gill, Jr. at (704) 382-3339.
Sincerely, Dhiaa M. Jamil Attachments
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www. duke-energy. com
U. S. Nuclear Regulatory Commission October 26, 2006 Page 2.
xc:
W. D. Travers, Region II Administrator U.S. Nuclear Regulatory Commission Sam Nunn Atlanta Federal Center, 23 T85 61 Forsyth St., SW Atlanta, GA 30303-8931 L. N. Olshan, Senior Project Manager (ONS)
U.S. Nuclear Regulatory Commission 11555 Rockville Pike Mail Stop 0-8 G9A Rockville, MD 20852-2738 J. F. Stang, Jr., Senior Project Manager (CNS & MNS)
U. S. Nuclear Regulatory Commission 11555 Rockville Pike Mail Stop 0-8 H 4A Rockville, MD 20852-2738 D. W. Rich NRC Senior Resident Inspector Oconee Nuclear Station J. B. Brady NRC Senior Resident Inspector McGuire Nuclear Station A. T. Sabisch NRC Senior Resident Inspector Catawba Nuclear Station
October 23, 2006
SUBJECT:
Fitness For Duty Unsatisfactory Laboratory Performance of a Blind Urine Drug Screen Quest Diagnostics incorrectly identified a Blind Specimen for Morphine as negative.
This needs to be reported to the NRC.
I have enclosed my report and the investigation by Dr. Brian Brunelli of Quest Diagnostics and his corrective actions. This is an unsatisfactory performance test result under 10CFR Part 26, Appendix A, 2.8(e)(4).
Sincerely, William E. Dukes, Jr., MD Corporate Medical Director Enclosures (2)
Duke MED/CAL SERVICES N nergy Duke Energy Corporation 526 South Church St.
Charlotte, NC 28202 Mailing Address:
October 23, 2006 EC020 / PO Box 1006 Charlotte, NC 28201-1006
SUBJECT:
Unsatisfactory Laboratory Performance of a Blind Urine Drug Screen A spiked blind specimen containing Morphine was incorrectly identified as negative by Quest Diagnostics Laboratory in Atlanta, Georgia. The specimen number 3266128 was submitted to the laboratory on 9/20/06. The specimen report was received at Duke Energy on 9/25/06. Upon discovery on 9/27/06, Duke Energy notified Quest Diagnostics of the discrepancy. The laboratory's investigation was completed on October 16, 2006.
The specimen initially screened positive for opiates by immunoassay testing.
Confirmation testing by gas chromatography/mass spectrometry did not verify opiates above the cutoff level, and thus reported as negative. Upon notification of the discrepancy from Duke Energy, the laboratory tested the specimen again and it did test positive for Morphine.
The laboratory investigated the error. Repeat confirmation testing was performed on all specimens in the original batch with specimen number 3266128. The investigation revealed that the sequential specimen prior to specimen number 3266128 was tested twice and specimen number 3266128 was not tested for confirmation initially.
Corrective action by the laboratory has been to review the standard operation procedures for the aliquotting process and the extraction process for confirmation testing.
Modifications to the procedure have been implemented and will prevent recurrence. See the enclosed letter from Dr. Brunelli, Operations Director of the Atlanta Quest Diagnostics laboratory. Also enclosed is a copy of the modification changes to the aliquotting process for confirmation testing. (Please note the enclosed change is for marijuana confirmation testing as an example of the process changes implemented for confirmation testing for all substances).
The laboratory correctly identified all seven other blind positive specimens with Morphine submitted to the laboratory in September. The laboratory's aliquotting error appears to be an isolated event.
Sincerely, William E. Dukes, Jr., MD Corporate Medical Director www. duke-energy. corn
QUEST DIAN ATLANTA 770838S012 10/16?06 03:39pm P. 002 Qizest liagnn~itic~s Ilcorp)orated 3175 Presidential Drive Atlanta, Gcorgia 30340 770.452.1.590 w%%w.qtcstdiagnnstfc.s.corn 44' Quest Diagnostics October 16, 2006 Dr. Gene Dukes Medical Review Officer Duke Power Company 526 South Church Street Charlotte, NC 28201.
Re: Blind Control 3266128
Dear Dr,
Dukes:
This letter is in response to your request for Quest Diagnostics to investigate the results of specimen identification number 3266128. Bascd on the information you provided, the specimen was a blind quality control sample that should have tested positive for Morphine.
Below is a summary of our investigation:
The specimen 3266128 screened Positive for Opiates by Immunoassay and was sent for confirmation analysis by Gas Chromatography/Mass Spectrometry. The confirmation results indicated dhe presence of Hydrocodone and Hydromorphone at concentrations below the cutoff As a result, the specimen was reported as Negative.
Following your notification that an error had occurred, the laboratory repeated the confirmation test on specimen 3266128 and obtained a Positive result for Morphine. This result is consistent with the expected result of the blind quality control sample. The laboratory proceeded to repeat confirmatory analysis on all specimens included in dte original Opiate confirmation batch and identified that the sequential specimen prior to 3266128 was aliquotted in duplicate and specimen 3266128 was not tested.
In order to address this issue, the laboratory has reviewed the standard operating procedures utilized for the confirmation aliquotting process and the confirmation extraction process and has implemented modifications to these procedures that will prevent this event from reoccurring.
11 --------
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.40' 41 44 FmOHI r CJJ If you have any questions pertaining to the information provided above, please do not hesitate to contact me directly at 770-936-5009.
Respectfully, Brian A. Brunelli Operations Director
QUEST DIAGN ATLANTA 70391 02Ž6 0
- 6mP 0
7709366012 10/20/06 02:2Gpm P. 002 Quest.Diagnostics Incorporated Site: ESATCO
Title:
Tetrahydrocannabinol Metabolite Analysis by GC/MS 2
Using 16 x 125 mm disposable culture tubes, prepare additional calibrators at 6.0 ng/mL and 15 ng/mL by making the following dilutions:
15 ng/mL - Using a calibrated pipette, add 1 mL of working THC Calibrator (150 ng/mL) to 9 mL of certified negative urine.
6.0 ng/mL - Using a calibrated pipette, add 0.4 mL of working THC Calibrator (150 ng/mL) to 9.6 mL of certified negative urine.
Cap and mix by gentle inversion at least 10 times before sampling.
Note: All three calibrators. (6.0, 15.0, & 150 nA/mL) must be extracted.
Extraction I
Obtain the test tube rack of qualitative aliquots (Rack 1) and worklist from the Pass Thru Window. Verify the accession number and sequence number on the specimen label match the accession number and sequence number on the worklist. If the numbers do not match notify a supervisor or manager.
2 Obtain as many 16 x 125 mm disposable culture tubes as necessary for the calibrators, controls, and samples. Place these tubes in Rack 2.
3 Add 100 pL (using SMI or equivalent) of working THC-d9 internal standard solution (1
- g/mL) to each 16 x 125 mm disposable culture tube in (Rack 2).
4 Quantitatively aliquot 3mL of the calibrators, controls and specimens using the following procedure:
-Pick up an aliquot from Rack 1 and place into an empty test tube rack (Rack 3)
-Pick up a test tube from Rack 2 containing internal standard and place in Rack 3. With an adjustable Finnpipette (or equivalent) add 3 mLs of calibrator, control or specimen from the aliquot tube or QC bottle to the tube with the internal standard. Note: the transfer of the aliquot should be performed while both test tubes are in the rack.
-Transfer the label from the aliquot tube to the tube with the internal standard and specimen aliquot. Gently swirl contents of tube to mix and place this tube in Rack 2.
-Discard the original aliquot tube with any residual sample, If a dilution is necessary, record the dilution factor, volume of deionized water, and the volume of specimen used to make the dilution on the worklist. Example:
1.5 mL sample/1.5 mL dH20 = x2.
-Observe all the test tubes in rack 3 to verify they all have equivalent volumes 5
Add 200 uL of 10 N KOH to each tube. Gently swirl the contents of the tube to mix.
(Caution: Use Eye Protection: Very Caustic) 6 Incubate samples for 10 minutes at 57 degree C.
7 Allow samples to cool to room temperature.
8 Add 2.0 mL of concentrated glacial acetic acid to each tube to obtain a pH range of 3-4.
Gently swirl the contents of the tube to mix.
,,. (Caution: Use Eye Protection: Strong Acid) 9 Label the extraction columns with the specimen sequence number and assemble the extraction columns on the extraction vacuum box. Plug all unused ports.
Initials:
/Q SOP ID:E JTCO004 SOP Version: J Date:
10/19/06 CONFIDENTIAL: Authorized for internal use only.
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