ML13107A607
| ML13107A607 | |
| Person / Time | |
|---|---|
| Site: | Surry  |
| Issue date: | 04/09/2013 |
| From: | Blasioli P Virginia Electric & Power Co (VEPCO) |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| 13-142 | |
| Download: ML13107A607 (5) | |
Text
VIRGINIA ELECTRIC AND POWER COMPANY RICHMOND, VIRGINIA 23261 10 CFR 26.719 April 9, 2013 Attention: Document Control Desk Serial No.: 13-142 U.S. Nuclear Regulatory Commission NL&OS/MAE: RO Washington, D.C. 20555-0001 Docket Nos.: 50-280/281 License Nos.: DPR-32/37 VIRGINIA ELECTRIC AND POWER COMPANY SURRY POWER STATION UNITS I AND 2 SUBMISSION OF FITNESS FOR DUTY REPORT Pursuant to 10 CFR 26.719(c)(1), Virginia Electric and Power Company (Dominion) is reporting a drug testing error discovered in performance testing at Quest Diagnostics (Quest),
a health and human services (HHS)-certified laboratory. On January 24, 2012, Blind Specimen 5088966 (Cocaine positive) was prepared by the Corporate Fitness-for-Duty (FFD) staff for shipment to Quest in Norristown, PA. The blind specimen was manufactured by Professional Toxicology Services, Inc of Lenexa, KS on December 6, 2012 and was from Lot Number 1212N-COC. This lot had an expiration date of June 6, 2013. The blind target drug concentration value was set at 540 ng/mL for Cocaine Metabolite.
The initial lab report from Quest reported the drug concentration value as 1273 ng/mL for Cocaine Metabolite on January 26, 2013. The Corporate Medical Review Officer (MRO) questioned the quantitative drug concentration value which was double the target value of 540 ng/mL. Under the direction of the MRO, FFD personnel prepared another blind specimen using a new Federal Chain of Custody Form (5089970) from the same positive cocaine blind bottle as Specimen 5088966. This sample was prepared on January 31, 2013. On February 6, 2013, Quest reported that Specimen 5089970 had a quantitative drug concentration value of 509 ng/mL for Cocaine Metabolite. Due to the discrepancy with the two results, the MRO requested a retest of the initial specimen (5088966) by Quest. The Quest Laboratory Director agreed to the retest since the issue involved a blind specimen. The retest of the initial blind specimen was reported to have a quantitative drug concentration value of 546 ng/mL.
Quest performed an investigation into this incident and their report, which includes corrective actions that were taken, is provided as an attachment to this letter.
If you have any questions, please contact Ms. Margaret Earle at (804) 273-2768.
Sincerely, Paul A. Blasioli For Vice President - Nuclear Support Services Virginia Electric and Power Company Attachment
Serial No.13-142 Docket Nos. 50-280/281 Page 2 of 2 Commitments made by this letter: None cc: U. S. Nuclear Regulatory Commission, Region II Regional Administrator Marquis One Tower 245 Peachtree Center Ave., NE Suite 1200 Atlanta, Georgia 30303-1257 Ms. K. R. Cotton NRC Project Manager Surry U. S. Nuclear Regulatory Commission One White Flint North Mail Stop 08 G-9A 11555 Rockville Pike Rockville, MD 20852-2738 NRC Senior Resident Inspector Surry Power Station
Serial No.13-142 Docket Nos. 50-280/281 Attachment Quest Diagnostics Investigation Surry Power Station Virginia Electric and Power Company (Dominion)
A Quest Diagnostics March 13, 2013 John Rogers Fitness for Duty/Access Supervisor Dominion Nuclear Protection Services 701 E Cary Street Richmond, Virginia 23219
Dear Mr. Rogers:
I am writing in response to your inquiry regarding a recent blind quality control sample quantitation issue. Two blind urine quality control samples from Dominion Virginia Power were received at Quest Diagnostics in Norristown, Pennsylvania on January 25, 2013. They were identified and reported as follows:
Specimen ID # 5088966 5088959 Laboratory ID 804067C 804109C Donor ID 5088966S 5088959S Collection Date 1/24/2013 1/24/2013 Report Date 1/26/2013 1/26/2013 Result Reported Cocaine metabolite Cocaine metabolite 1273 ng/mL 555 ng/mL We were notified on 2/20/2013 that the specimen identified as laboratory number 804067C was not in the expected quantitative range.
Investigation:
" Both blind quality control specimens screened positive for cocaine metabolites by enzyme immunoassay and were set up in the same confirmation batch tested by gas chromatography/mass spectrometry (GC/MS) on January 26, 2013.
" The specimen in question (804067C) was retested and the repeat quantitation for cocaine metabolite was determined to be 546 ng/mL.
- It was verified that the correct specimen aliquots were provided to the confirmation area for testing. This was accomplished by review of specimen storage records in the computer and specimen ID verification reports.
" The worklist and analytical chromatograms were reviewed for specimen dilution or multiplication factors on the data. Everything appeared to be correct.
- All non-regulated specimens from the two confirmation batches performed by the forensic scientist who performed the test were repeated to help identify the problem. All sample retest values were consistent with the original values reported. It was also noted the second blind quality control sample received from Dominion Virginia Power (804109C) was the adjacent sample in the confirmation test batch and did test correctly.
- The forensic scientist who performed the confirmation testing was interviewed. He has performed extraction procedures in the laboratory for two years and has successfully passed annual competency evaluations. It was verified that he followed the correct Standard Operating Procedure and that the pipets he used in the extraction process were calibrated. It was noted that the blind quality control specimen in question was the first sample in the batch followed by the second blind quality control sample that was reported correctly.
- Based on what we have reviewed, it appears to us that the scientist may not have properly primed the pipet prior to addition of internal standard to the sample. Correct internal standard addition is a critical step in the extraction process to perform accurate quantitative analysis.
Corrective Action:
Corrective action steps have been taken.
- 1. This incident was reviewed with the appropriate staff.
- 2. The forensic scientist who performed the original confirmation tests was retrained by his supervisor. His performance on the bench was also observed for competency evaluation.
We regret that we failed to accurately quantitate this blind quality control sample but are confident that the corrective actions taken should effectively eliminate a future recurrence of such an incident.
Should have any additional questions or concerns, please call me at (877) 642-2216 x 4502.
Sincerely, Susan Mills Operations Director