ML13330B521
| ML13330B521 | |
| Person / Time | |
|---|---|
| Site: | San Onofre  |
| Issue date: | 06/17/1991 |
| From: | Morgan H SOUTHERN CALIFORNIA EDISON CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9106200191 | |
| Download: ML13330B521 (3) | |
Text
0P, Southern California Edison Company P. 0.
BOX 128 SAN CLEMENTE, CALIFORNIA 92674-0128 H. E. MORGAN TELEPHONE VICE PRESIDENT AND SITE MANAGER 714-368-9470 SAN ONOFRE June 17, 1991 U. S. Nuclear Regulatory Commission Document Control Desk Washington, D.C. 20555
Subject:
Docket Nos. 50-206, 50-361 and 50-362 Report of Unsatisfactory Blind Performance Test Results San Onofre Nuclear Generating Station, Units 1, 2 and 3 Pursuant to 10 CFR Part 26, Appendix A, Section 2.8(e), this submittal summarizes Southern California Edison's (SCE) investigation concerning unsatisfactory blind drug performance test results-. -Attachment 1 provides this summary'and the corrective actions taken. Attachment 2 provides documentation concerning the cause of the unsatisfactory blind drug performance test results. This event did not compromise our employee sample testing program.
If you require any additional information, please so advise.
Sincerely, Attachments cc:
C. W. Caldwell (USNRC Senior Resident,Inspector, Units 1, 2 and 3)
J. B. Martin (Regional Administrator, USNRC Region V) 9106200191 910617 PDR ADOCK 05000206 P
ATTACHMENT 1
SUMMARY
OF UNSATISFACTORY BLIND PERFORMANCE TEST RESULT On May 19, 1991 and May 24, 1991, two blind specimens were reported negative by the NIDA-certified testing laboratory used by SCE, the Nichols Institute Substance Abuse Testing (NISAT)
Laboratory. These blind specimens should have tested positive for Methadone.
(Although not required by 10 CFR Part 26, Appendix A, SCE has included Methadone on its list of controlled substances.)
Subsequent Gas Chromatography/Mass Spectrometry (GC/MS) testing performed by NISAT reported Methadone levels below the 300 ng/ml cut-off level, with the first specimen having 128 ng/ml Methadone and the second 140 ng/ml.
Both samples submitted were from the same lot.
In a January 17, 1991 letter to the NRC, regarding previous unsatisfactory blind drug performance test results, SCE committed to submit a sample from each lot for Quality Control (QC) verification prior to use of the lot for performance testing. In accordance with this commitment, SCE submitted a sample, one of three provided, from the received lot and, on May 4, 1991, NISAT reported the sample as containing 579 ng/ml Methadone, well above the cut-off level of 300 ng/ml.
SCE submitted the remaining two blind specimens in accordance with supplier specified shelf life, well before the September 30, 1991 lot expiration date. Notwithstanding this, the.specimens appear to have degraded to below the 300 ng/ml cut-off level, thus resulting in the negative report by NISAT.
The specimen supplier, Biomedical Testing Laboratories, at SCE request, submitted a sample from the affected lot on June 4, 1991 to their NIDA-certified lab for further testing. This testing revealed that the sample was below the cut-off level for Methadone with the sample quantified at 160 ng/ml.
The supplier could find no cause for the degradation of the Methadone.
In an effort to enhance blind performance testing, SCE, utilizing the consulting services of Comprehensive Drug Testing, conducted an extensive survey to locate a superior blind specimen provider.
As a result of this survey, effective June 4, 1991, SCE discontinued processing blind performance samples provided by Biomedical Testing Laboratories and has technically qualified two blind performance specimen providers, ElSohly Laboratories and Bio-Rad. These two laboratories will serve as SCE's primary and secondary suppliers for blind performance testing samples.
Page 1 of 1 Biomedical T Ino-sjbsj~r-of5':)
Labo1 Southern California Ediso 14300 Mesd Road k~
Songs Warehouse G48
~Rm 1I San Clemente, CA 92672
~June If, 19911 Dcar Ms. Blue, fI Further to your q ues Aons abo4t ASURTEST, Lot C172, positive for Methadone at a target levOl of.740 ng/ml....
on retes Ing this lot was reported to contain 160) n,/rl of Mathadone.
This d re.,se is unexpected
.and I n explicable. We hav) not obs rved such a do2cr se in any other lotl of ASURTEST. We are chec~iRng our Jnven'ory to dete ire if this is an analous occurence, or i thert i a discernible P tern.
- I apologize for the nconveni nce and will 'Ifo mn you of the outcome.
Si nceroly,I Dr. Richard Baranczuk