ML18153A992
| ML18153A992 | |
| Person / Time | |
|---|---|
| Site: | Surry, North Anna  |
| Issue date: | 07/05/1994 |
| From: | Ohanlon J VIRGINIA POWER (VIRGINIA ELECTRIC & POWER CO.) |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| 94-168, NUDOCS 9407130210 | |
| Download: ML18153A992 (10) | |
Text
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VIRGINIA ELECTRIC AND POWER COMPANY RICHMOND, VIRGINIA 23261 July 5, 1994 United States Nuclear Regulatory Commission Attention: Document Control Desk Washington, D. C. 20555 Gentlemen:
VIRGINIA ELECTRIC AND POWER COMPANY SURRY POWER STATION UNITS 1 AND 2 NORTH ANNA POWER STATION UNITS 1 AND 2 FITNESS FOR DUTY PROGRAM Serial No.94-168 NURPC Docket Nos. 50-280 50-281 50-338 50-339 License Nos. DPR-32 DPR-37 NPF-4 NPF-7 BLIND PERFORMANCE TEST INVESTIGATION RESULTS Pursuant to 1 O CFR 26, Appendix A, Subpart B, §2.8 (e)(4), Virginia Electric and Power Company has performed an investigation concerning blind performance testing results. Details of an apparent discrepancy and the ensuing investigation are included in Attachment 1. Letters from the HHS-certified laboratory concerning the follow-up investigation are included in Attachment 2.
Should you have any questions, please contact us.
Very truly yours, QPCW~
J. P. O'Hanlon Senior Vice President - Nuclear Attachments If.',...,
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9407130210 940705 PDR ADOCK 05000290 P
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U. S. Nuclear Regulatory Commission Region II 101 Marietta Street, N. W.
Suite 2900 Atlanta, Georgia 30323 Mr. M. W. Branch NRC Senior Resident Inspector Surry Power Station Mr. R. D. Mcwhorter NRC Senior Resident Inspector North Anna Power Station Mr. L. L. Bush U. S. Nuclear Regulatory Commission Division of Reactor Inspection and Safeguards MS 9D24 One White Flint North 11555 Rockville Pike Rockville, Maryland 20852 e
e ATTACHMENT 1 BLIND PERFORMANCE TEST INVESTIGATION RESULTS
BLIND PERFORMANCE TEST INVESTIGATION RESULTS During a review of blind performance test results, a sample (Specimen No.
87153516}, which had screened as positive for marijuana (THC} (~50 ng/ml} at our onsite testing facility at North Anna Power Station in September, 1993, was identified by Company Employee Health Services personnel to have been screened by our Department of Health and Human Services (HHS} certified laboratory with negative results (<50 ng/ml}. We directed our HHS laboratory to provide the quantitative value of the split, referee specimen (Specimen No. 86910064).
The follow-up gas chromatography/mass spectrometry (GC/MS} confirmatory test confirmed the presence of THC at 72 ng/ml. As a result, we requested our HHS laboratory to provide an explanation and documentation of their initial screening and subsequent confirmatory testing (GC/MS} performed on the specimen in question. Letters dated December 13, 1993, and January 24, 1994, are pertinent to this particular case.
We independently verified that the subject blind sample provided by our supplier had indeed been spiked with THC. A National Institute on Drug Abuse (NIDA}-certified laboratory performed screening and confirmatory testing on an aliquot from the batch from which the blind sample was produced. Furthermore, panels of blind performance specimens were processed at an increased rate specifically to provide additional information in this area of discrepancy.
While the investigation continued, a second, separate blind performance sample (Specimen No. 109033746), which had screened as positive for THC (~50 ng/ml) at our onsite testing facility at Surry Power Station in January, 1994, was identified by Company Employee Health Services personnel to have been screened by our HHS laboratory with negative results (<50 ng/ml}. Again, we directed our HHS laboratory to provide the quantitative value of the split, referee specimen (Specimen No.
109309534). The follow-up GC/MS confirmatory test confirmed the presence of THC at 52 ng/ml. Our HHS laboratory provided an explanation and documentation of their initial screening and subsequent confirmatory testing (GC/MS) performed on that specimen in a letter dated February 7, 1994.
Copies of the HHS laboratory letters which describe the analysis process and results for both samples are enclosed in Attachment 2.
Page 1 of 1
ATTACHMENT 2 HHS-CERTIFIED LABORATORY LETTERS DATED:
DECEMBER 13, 1993 JANUARY 24, 1994 FEBRUARY 7, 1994
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,~.. -Roche Biomedical laboratories A Member of the Roche Group December 13, 1993 Ms. Nancy Cross Employee Heal th Services' Virginia Power P.O. Box 26666 Richmond, VA 23261
Dear Ms. Cross:
e Rocne Biomedicai L3boraior1es. inc.
P.O. Box 12652 3308 Chapel Hill/Nelson Highwav Researcn Triangle Pnrk. NC 27709 Telephone: 919 549-8263 The results of analyses for the specimens we discussed are presented in the following report.
If you have additional questions, please call me at (919) 248-6703.
Paula S. Childs, Ph.D., D-ABFT Vice President Toxicology Operations PSC/lmm Enclosure
REF: 266-743-1273 267-743-2117 (CCU: 87153516)
(CCU: 86910064)
(CCU: 100041581)
JONATHAN N. SITT "TEST" "SPECIAL HANDLING" MATE# FOR CCU: 86910064 N 001088 The "TEST" specimen and the "SPECIAL HANDLING" specimens were received at the Roche CompuChem Laboratory on September 23, 1993.
The "TEST" specimen was analyzed and the immunoassay results were as follows:
THC (50 ng/mL calibrator)
Specimen 87153516 1195 1164 31 The results were reported as negative on September 29, 1993.
No additional tests were performed, and the specimen was destroyed.
The "SPECIAL HANDLING" specimen was retrieved from storage upon request for confirmation testing at LOD for THC-COOH.
The specimen was found to contain 72 ng/mL THC-COOH (GC/MS).
Subsequent screening of this specimen was conducted with the following results:
THC (50 ng/mL calibrator)
Specimen 86910064 1100 1114
+ 14 Review of the information indicates that the screening results for the "TEST" specimen and the "SPECIAL HANDLING" specimen were very close to the calibrator result (cut-off).
It is likely that if the "SPECIAL HANDLING" specimen was labeled as the "TEST" specimen, that a positive result would have been issued from the laboratory.
The date at the top left section of the form was 9-13-93.
The specimen was shipped to the laboratory on 9-22-93.
The storage of the specimen and delay in shipping to the laboratory may account for some of the loss of THC activity.
The manufacturer of the control material for this specimen has submitted a bottle of the control.
Evaluation of the control at the Roche CompuChem Laboratory is in progress.
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01/24/94 13:51
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Laboratories A Member of the Roche Group January 24, 1994 Dr. Paul Stairs Medical Director Virginia Power Company P. o. Box 2666 Richmond, VA 23261
Dear Dr. Stairs:
COMPOCREM
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Roche Biomedical Laboratories, Inc.
P.O. Bax 12652 3308 Chapel Hill/Nelson Highway Research Triangle Parle, NC 27709 Telephone: 919 549*8263 Enclosed is the completed report concerning the specimens submitted to the Roche CompuChem Laboratory from the Bensinger Dupont Proficiency Testing Program.
If you need additional information, please call me at (919)248-6703.
S~ncerely yours,
~J~
Paula S. Childs, Ph.D., D-ABFT Vice President, Toxicology Operations
~001/002
e919 24s 6462 COMPUCHEM e
PROFICIENCY TESTING SPECIMENS FOR THC ANALYSIS
[a] 002/002 On December 1~, 1993, two unsealed bottles of control urine (Lot #008) were received from Dr. Stuart Bogema at the request of Dr. Dick Bucher. The specimens were analyzed using immunoassay on 12/10/93 and again on 1/17/94 with the following results:
SPECIMEN#
ABS, READ, (12/10)
ABS. READ. (1/17) 104959671 1195 (Pos, +98) 1177 (Pas, +16) 104959689 1203 (Pas, +106) 1175 (Pas, +14) 100041581 *
(not teated 12/10) 1149 (Neg, -12) 50 ng/mL cal.
1097 (cut-off) 1161 (cut-off)
- Jonathan Sitt specimen results 87153516 1164 (Neg, -31) 9/93 100041581 1114 (Pas, +14) 12/93 1149 (Neg, -12) 1/94 {above)
The two specimens received in December from Dr. Bogema were analyzed using GCMS to quantify the THC-COCH in the control material.
The volume remaining for specimen 100041581 (Jonathan Sitt, "Special Handling*) was not sufficient for additional GCMS testing. The GCMS results were as follows:
SPECIMEN#
104959671 104959689
- GCMS C12/93) 68 84 GCMS ll/94) 69 70 In summary, the specimen identified as Jonathan Sitt did not screen positive in the original test {9/93), or in the re-screen (1/94) and it appears that the specimen may have degraded prior to its receipt in the lab.
Furhter, the control materials appear to have degraded, as noted in the diminshed absorbance change between the calibrator and specimens from 12/93 to 1/94.
The GCMS results were virtually unchanged during the period from 12/93 to 1/94.
~ctfully submitted,
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Paula S. Childs, Ph.D., D-ABFT Vice President, Toxicology Operations 2
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P.O. Box 12652 3308 Chapel Hfll/Nel1on Highway Research Triangle Park, NC 2n09 a subtddlary of R1>ehe Biomedical Laboratories, Inc.
February 07, 1994 Dr. Paul Stairs Medical Director Virginia Power Company P. o. Box 2666 Richmond, VA 23261 REF:
028-743-1604-0 028-743-1604-1 LESLIE S. PENNERSON
Dear Dr. Stairs:
(919) 549-8263 (CCU: 109033746)
(CCU: 109309534)
ORIGINAL TE~T LOD RE"l'EST The above referenced specimen was received at the Rocha Compuehem Laboratory on January 28, 1994, and screened by an l'DA approved immunoassay. The results are as follows:
Specimen 109033746 1122
.llQ2 19 The results were reported as negative on January 28, 1994.
The original specimen was retrieved from storage upon request for confirmation testing at LOD for THC-COOH. The specimen was found to contain 52 ng/mL THC-COOH (GC/MS).
Review of the results indicate that the initial screening results for the ~pecil!len were very close to the calibrator result (cut-off).*
Minimal deterioration of material targeted to 75 ng/-.L THC can occasionally cause a negative result at a 50 ng/mL cut-off.
If you have any further questions, please give me a call at l-BOO-B33-3984 ension 6774 Kevin Wilson Sr. Laboratory Certifying Scientist