ML20125E419
| ML20125E419 | |
| Person / Time | |
|---|---|
| Site: | Calvert Cliffs  |
| Issue date: | 12/03/1992 |
| From: | Guarnieri S BALTIMORE GAS & ELECTRIC CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| Shared Package | |
| ML19303F118 | List: |
| References | |
| NUDOCS 9212170048 | |
| Download: ML20125E419 (3) | |
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j BALTIMORE G AS AND i
ELECTRIC i t$
CHARLES CENTER
- P.O. BOX 1475
- BALTIMORE. MARYi AND 21203-1475 l
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l December 3, IV12 U. S. Nuclear Regulatory Commission Washington, DC 20555 NITENTION:
Document Control Desk SUlHECT:
Calvert Cliffs Nuclear Power Plant Unit Nos.1 & 2; Docket Nos. 50-317 & 50-318 10 CFR Part 26, Unsatisfactory Performance Testing Results, Request for
]lepartment of IIcalth and Human Services (DIIIIS)Investication Gentlemen:
As required by 10 CFR Part 26, Appendix A, this letter informs you of two unsatisfactory performance testing results which were conducted by National Center for Forensic Science.
Additionally, this letter requests a DIIIIS investigation of the unsatisfactory test results. Two blind performance test urine samples, containing amphetamine levels of 2,236 ng/ml., were reported as negative on November 16,1912.
National Center for Forensic Science was contacted on November 17,1992, and reported that the samples tested positive for amphetamines on initial testing, gas chromatography and mass spectrometry (MS). Ilowever, the ion ratios on the MS were not within the requirements established by National Institute of Drug Abuse (NIDA), and thus, the specimens were reported negative, as required by NIDA. National Center for Forensic Science also reported they had altered their MS process in the last month by adding periodate to oxidize ephedrine and related compounds. Both of the above samples were retested without periodate and reported as positive for amphetamines.
National Center for Forensic Science reports they now have changed their standard operating procedures to require MS positive amphetamines with ion ratios not within NIDA requirements to be retested without the periodate.
National Center for Forensic Science reports they have not encountered problems with ion ratios using periodate in MS for other samples containing amphetamines, including proficiency tests submitted by NIDA. We submitted the other amphetamine positive blind performance test urines from the same amphetamine batch; it was reported as positive, but required the omission of the periodate for the ion ratio to be within.NIDA requirements.
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9212170048 921203 DR ADOCK 05000317 ih PDR
Document Control Desk '
December 3,1992 Page 2 Dr. EISohly of EISchly Laboratories, the supplier of the blind performance urine samples, was contacted. Ile reported he developed the periodate addition to the MS amphetamine testing and has not encountered any problems with ion ratios with testing of EISohly Laboratory's blind performance urine samples tested by EISohly Laboratory and other. laboratories. On November 23,1992, Dr. EISohly reported an aliquot from the same amphetamine batch was tested with periodate and no ion ratio problems were discovered.
Pursuant to 10 CFR Part 26, Appendix A, Subpart B, Section 2.8(c)4, a request was made to Dr. Water Vogel for a DilllS investigation.
He advised the request be made through Mr. L L Bush, Jr. (NRC). We are requesting an investigation be conducted to determine the cause of the ion ratio being outside the NIDA requirements, which results in the false negative teruits.
The following Attachments were gathered in our investigation:
(1)
Certificate of Analysis from EISchly Laboratory for Amphetamine Batch A-0208; -
(2)
Negative test results from National Center for Forensic Science, dated November 16,1992, for the two false negative specimen; (3)
Positive test results from National Center for Forensic Science, dated November 20,1992, for the other amphetamine specimens; (4)
MS runs of both false negative samples with cover letter from Dr. Caplan, National Center for Forensic Science; (5)
Letter from Dr. EISohly, dated Nov:mber 18,1992, with documentation of testing of Amphetamine Batch A-0208 from which both snecimens were taken; and (6)
Article written by Dr. EISchly, et.al., which discusses the use of periodate in amphetamine testing.
As other documents are received concerning this investigation,- they will be forwarded to you. We appreciate your assistance in arranging an investigation with DHIIS of this event. If you have any questions, please contact Joyce IIolleman at (410) 260-3751.
Should you have any questions regarding this matter, we will he pleased to discuss them with you.
Very truly yours,
,$Ylld&tuLw S. R. Guarnieri. M.D.
Safety and Medical Senices SRG/JMO/ dim Attachments: As Stated g
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-- Document Control Desk
- necember 3, IV12:
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(Without Attachments)
' D. A. Brune, Esquire J. E. Silberg, Esquire R. A. Capra, NRC D. G. Mcdonald, Jr., NRC T. T. Martin, NRC P. R. Wilson, NRC R.1. McIran, DNR J. II. Walter, PSC (With Attachments)
L L. Bush, Jr. (NRC) i t
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