ML18153B045
| ML18153B045 | |
| Person / Time | |
|---|---|
| Site: | Surry, North Anna  |
| Issue date: | 08/18/1994 |
| From: | Bush L Office of Nuclear Reactor Regulation |
| To: | Bush D VIRGINIA POWER (VIRGINIA ELECTRIC & POWER CO.) |
| References | |
| NUDOCS 9408300014 | |
| Download: ML18153B045 (2) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555--0001 August 18, 1994 Dr. Donna Bush Chief, Drug Testing Section Division of Workplace Programs Substance Abuse and Mental Health Administration 5600 Fishers Lane (Room 13-A-54)
Rockville, Maryland 20857
Dear Dr. Bush:
Forwarded for your action in accordance with Section 2.S(e) of Appendix A to 10 CFR Part 26 are two reports of unsatisfactory testing results involving HHS-certified testing laboratories.
Copies of the reports are attached.
- 1. Virginia Electric and Power Company's July 5, 1994, letter (enclosure 1) describes two unsatisfactory test results for blind performance samples:
North Anna.
A bl ind performance test sample (87153516, 11Jonathan Sitt 11
) was screened positive for marijuana by the North Anna power plant and submitted to Roche Biomedical Laboratories of Research Triangle Park, NC, for confirmation.
Roche found it contained 31 ng/ml THC and reported it as negative on September 29, 1994.
North Anna then asked Roche to re-test using the split/referee sample (86910064), since the original sample (87153516) was not available. The Roche GC/MS test found 72 ng/ml THC.
Roche concluded that 11 storage of the specimen and delay in shipping to the laboratory may account for some of the loss of THC activity.
11 (The 11Jonathan Sitt 11 test sample was dated 9-13-93; it was shipped to Roche on 9-22-93.)
The sample supplier shipped Roche a bottle of control, which Roche evaluated and concluded that "the specimen identified as Jonathan Sitt did not screen positive in the original test (9/93), or in the re-screen (l/94) and it appears that the specimen may have degraded prior to its receipt in the lab.
Further, the control materials appear to have degraded, as noted in the diminished absorbance change between the calibrator and specimens from 12/93 to 1/94.
The GC/MS results were virtually unchanged during the period from 12/93 to 1/94." This completed the investigation.
Surry.
A blind performance test sample (109033746) was screened positive by the Surry nuclear power plant and submitted to Roche Biomedical Laboratories of Research Triangle Park, NC, for confirmation.
Roche found it contained 19 ng/ml THC and reported it as negative on January 28, 1994.
Surry asked Roche to retrieve the original sample from storage and do a GC/MS LOO test for THC.
The GC/MS test (109309534) found 52 ng/ml THC.
Roche reported that 11 review of the results indicate that the initial screening results for the specimen were very close to the calibrator result (cut-off).
Minimal deterioration of material targeted to 75 ng/ml THC can occasionally cause a negative result at a 50 ng/ml cut-off." This completed the investigation.
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Dr. Donna Bush 2. Entergy Operations, Inc. reported one unsatisfactory blind performance test in their letter dated August 9, 1994 (enclosure 2).
Waterford nuclear power plant screened a performance test sample (B94544) as positive for PCP and submitted it to the Doctors and Physicians Lab (D&PL) of Leesburg, FL, for confirmation.
D&PL found a TDX of 24.57 PCP in position 3 and reported it negative on June 14, 1994.
The sample supplier confirmed that GC/MS tests by two different labs had found 39 ng/ml and 27.6 ng/ml PCP.
Waterford then resubmitted a portion of the original sample to DP&L, verifying that DP&L had been told previously that the only methodologies to be used for Entergy samples would be fluorescence polarization immunoassay (FPIA) for screening and GC/MS for confirming (part of the corrective action for a previous unsatisfactory blind performance test).
D&PL re-tested the original sample portion on June 15, 1994, and found a TDX of 34.25 in position 5, noting a "positive 11 for PCP (above the 25 ng/ml cutoff).
GC/MS testing confirmed the sample was positive for PCP, and D&PL reported that both tests were positive for PCP.
The investigation concluded that the samples had been correctly placed in the test cartridges, that control results were within acceptable ranges, that no other positions had positive results or levels near the cutoff, that the correct samples had been tested, and that no human errors had occurred.
No explanation could be postulated, and the testing error could not be duplicated.
The cause was concluded to be indeterminate.
In an effort to prevent future occurrences, D&PL will increase attention to QAS control and will recalibrate the PCP assay when values approach the lower end of acceptability.
(D&PL is now SmithKline Beecham Clinical Laboratories.)
If you have any questions, please call me at 301-504-2944.
Enclosures:
As stated DISTRIBUTION w/o ENCLOSURES:
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L. Bush PDR r/"
P. McKee PSGB r/f DISTRIBUTION w/ ENCLOSURES:
C. Hendren E. Koup Sincerely; Original signed by:
Loren L. Bush Reactor Safeguards Branch Division of Radiation Safety and Safeguards Office of Nuclear Reactor Regulation OFC PSGB:NRR PSGB:NRR BC:PSGB:NRR Al/_/.
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PMc DATE 08 /18 /94 08 /18 /94 08 /18 /94 Document Name:
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