ML13317B268
| ML13317B268 | |
| Person / Time | |
|---|---|
| Site: | San Onofre  |
| Issue date: | 01/17/1991 |
| From: | Morgan H SOUTHERN CALIFORNIA EDISON CO. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NUDOCS 9101230155 | |
| Download: ML13317B268 (5) | |
Text
Southern California Edison Company P. 0.
BOX 128 SAN CLEMENTE, CALIFORNIA 92672 H. E. MORGAN TELEPHONE VICE PRESIDENT AND SITE MANAGER 714-368-9470 SAN ONOFRE January 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 Drug Performance Test Results San Onofre Nuclear Generating Station, Units 1, 2 & 3 Pursuant to 10CFR26, Appendix A, Section 2.8(e), this submittal summarizes Southern California Edison's (SCE) investigations concerning unsatisfactory blind drug performance test results. Attachment 1 summarizes each occurrence. One of these occurrences is attributa'ole to the testing program of our National Institute of Drug Abuse (NIDA)-certified laboratory, and documentation on this instance is provided as. None of these events compromised employee sample testing.
During a recent audit of our substance abuse program by an independent consulting firm it was determind th-ai t SCEz failed e
uo bind d
7 results to the NRC as required by 10CFR26, Appendix A, Section 2.8(e)(4). These blind performance test results were not reported to the NRC when they were initially received because it was incorrectly decided that these specific results were not "unsatisfactory" test results. The bases for this decision were the results did not indicate a laboratory testing error and there was a technical reason for each test result. However, as a result of the recent audit, we now recognize that these results should have been reported.
SCE has investigated each occurrence, and corrective actions. identified in Attachment 1 have been implemented. In addition, SCE is implenienting progran changes, including appropriate training, to ensure future unsatisfactory test results are reported in accordance with 10CFR26. We plan to implement these program changes and complete training by February 1, 1991.
If you require any adiditonal information, please so advise.
Sincerely, 9101230155 910117 PDR ADOCK 000"'
P PD
-2 MSZenker Attachments cc:
C. W. Caldwell (USNRC Senior Resident Inspector, Units 1, 2 and 3)
J. B. Martin (Regional Administrator, USNRC Region V)
ATTACHMENT 1
SUMMARY
OF UNSATISFACTORY BLIND PERFORMANCE TEST RESULTS ADMINISTRATIVE ERROR IN REPACKAGING OF SPECIMENS During the initial phase of the blind performance test specimen program, specimens were prepared by SCE for shipment to the NIDA-certified testing laboratory used by SCE, Nichols Institute Substance Abuse Testing (NISAT). A series of administrative errors occurred during SCE's repackaging of the specimens resulting in discrepancies between the anticipated results and the NISAT-reported results. The chain of custody numbers were subsequently reconciled by SCE.
Administrative procedures were strengthened following this event to preclude further difficulties in this area of the program.
PCP ENZYME MULTIPLIED IMMUNOASSAY TECHNIQUE (EMIT) TESTING DISCREPANCIES On April 3, 1990 and April 20, 1990, respectively two blind specimens were reported negative by NISAT when they should have tested positive for phencyclidine (PCP). On September 27, 1990, four blind specimens were reported negative by NISAT when they should have tested positive for PCP.
SCE's contract with NISAT during this period stipulated a specimen must test positive on two consecutive EMIT tests administered on two different devices before being submitted to gas chromatography/mass spectrometry (GC/MS) confirmation testing. These specimens tested positive on the first EMIT test and negative on the second EMIT test and thus were reported to SCE accordingly.
No further investigation of the April 3 and April 20 events took place because it was believed that minor variability in EMIT testing caused the conflicting results.
Additional review of the September 27 event by SCE resulted in NISAT advising SCE on December 27, 1990 that they had been using two different cut off levels on the two EMIT tests, 25 ng/ml and 75 ng/ml, which was contrary to SCE's contract specifications and the Part 26 cutoff level for PCP of 25 ng/ml.
SCE instructed NISAT to permanently discontinue the second EMIT test on October 24, 1990. Specimens testing positive on one EMIT test at the 25 ng/ml cutoff level are sent directly to GC/MS testing.
INSUFFICIENTLY SPIKED BLIND SPECIMENS On April 30, 1990, one blind specimen was reported negative by NISAT when it should have tested positive for benzodiazepine. GC/MS testing by the laboratory was performed with a reported quantification below the cut off level for benzodiazepine, indicating an improperly spiked blind specimen.
Page 1 of 2
ATTACHMENT 1
SUMMARY
OF UNSATISFACTORY BLIND PERFORMANCE TEST RESULTS On November 8, 1990, one blind specimen was reported negative by NISAT when it should have tested positive for morphine. On December 19, 1990, it was confirmed by the blind specimen supplier, Biomedical Testing Laboratories, that the specimen was not spiked at a concentration sufficient to test positive.
On November 26, 1990, one blind specimen was reported negative by NISAT when it should have tested positive for benzodiazepine. The results of GC/MS testing by NISAT conducted on ten other specimens extracted from the same lot identified that the specimens in the lot contained between 325 ng/ml to 369 ng/ml of benzodiazepine, versus the 600+ ng/ml as reported by the blind specimen supplier. On December 20, 1990, Biomedical confirmed that the remaining specimens from this lot had degraded from the original spiked level of 820 ng/ml, tested on May 29, 1990, to 640 ng/ml, tested on Ober 19, 1990. Biomedical indicated, and it is SCE's conclusion, that further deterioration of the product may have affected the shipment after leaving Biomedical."
In all incidences the blind specimen suppliers were instructed to ensure the spiked specimens contain the specified quantity of controlled substances in accordance with SCE's contract. Following the December 20, 1990 response from Biomedical, SCE has implemented a Quality Control program to test the concentration of blind specimens upon receipt before introducing a given specimen lot into the performance testing program.
DHHS/NIDA TESTING PROCEDURE CHANGES On December 26, 1990, two blind specimens wer e reported negative by NISAT when they should have tested positive for methamphetamine.
On December 26, 1990, NISAT advised SCE that the Department of Health and Human Services/National Institute of Drug Abuse (DHHS/NIDA) had issued a temporary procedure on December 21, 1990, revising the criteria for methamphetamine testing. As of December 22, 1990, specimens must contain, in addition to the previous requirement of 500 ng/ml methamphetamine, 200 ng/ml of amphetamine, a metabolite of methamphetamine.
Specimen vendors have not previously been required to spike specimens with the metabolite amphetamine. As a consequence, the blind specimens provided to NISAT on December 20, 1990, under our existing contract, did not contain amphetamine (the new standard), resulting in the "false negative" test result.
SCE has modified its blind sample specifications to meet the new criteria for methamphetamine/amphetamine in accordance with the new DHHS/NIDA guidance.
Page 2 of 2 NISAT Laboratories, Inc.
8985 Balboa Avenue Page 1 of 1 San Diego. California 92123 611-694-5050 FAX: 619-560-6601 Nichols Institute Substance Abuse Testing December 27, 1990 Ms. Sharon Blue Southern California Edison/SONGS Mesa Bldg. #G48, Room 114 San Clemente, CA 92672
Dear Ms. Blue:
This letter is in reference to six (6) "blind" specimer s submitted to'NiSAT thit apparently contained phencyclidine (PCP). The sanDles are:
SCE 11061 SCE 11059 SCE 11062 SCE.11060 SCE 01289 SCE 01879 The above specimens were positive for PCP on the initial screen using the Hitachi analyzer and a 25 ng/mL cut-off level. At the time SCE had a requirement that a second screening test using a different instrument had to be performed on those specimens that were positive on the initial screen. NISAT used the ETS instrument for this second screen. The reason the second screens were negative is that the ETS can only test for PCP at the 75 ng/mL cut-off level. Contact with Syva revealed that no ETS protocol exists for screening PCP at the 25 ng/mL level. Consequently specimens containing between 25 and 75 ng/mL of PCP would screen positive on the initial test against a 25 ng/mL cut-off but would be negative on the second screen against a 75 ng/mL cut-off.
This situation will not recur because SCE's requliement for a second screen has been discontinued. Additionally, NISAT no longer uses the ETS instrument for SCE specimens.
Hopefully the above information will assist you in resolving this issue.
Sincerely, ames A. Callies Scientific Director