ML20147D824
| ML20147D824 | |
| Person / Time | |
|---|---|
| Issue date: | 02/11/1997 |
| From: | Bush L NRC (Affiliation Not Assigned) |
| To: | Bush D MARYLAND, STATE OF |
| References | |
| NUDOCS 9702180036 | |
| Download: ML20147D824 (2) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION f
WASHINGTON, D.C. 20555 4 001 l
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February 11, 1997 Dr. Donna Bush Chief, Drug Testing Section Division of Workplace Programs i
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 2.8(e) of Ahpendix A to 10 CFR Part 26 are reports of unsatisfactory testing results involving HHS-1 certified testing laboratories.
Copies of the reports are attached.
- 1. Houston Lighting and Power Company letter of July 3, 1996, reported a false i
negative blind performance test by Laboratory Specialists Incorporated of Belle Chase, Louisiana, for a sample spiked with phencyclidine (PCP).
The investigation concluded that, although the initial screening was positive, subsequent data entries apparently introduced several errors - i.e., sample entered as negative, sample incorrectly color-coded, and the chain of custody (C0C) for the sample became attached to another sample's C00 document. The lab implemented several corrective actions.
(Enclosure 1)
- 2. New York Power Authority (NYPA) letter of September 18, 1996, reported two false negative blind performance tests by LabCorp, Raritan, New Jersey, for opiate samples. The lab responded that data entry for drug profile 734057 was "somewhat complicated...because of additional steps we have been taking to enter results as NEGATIVE or POSITIVE, rather than the usual numerical val ues. " The lab implemented a " standardized, more concise method for data entry," as described in their letter (attached).
(Enclosure 2)
- 3. Duke Power Company letter of September 24, 1996, reports a false negative blind performance test for a marijuana specimen by SmithKline Beecham of Atlanta, Georgia. The investigation concluded that the error apparently resulted because the certifying scientist who did the manual review of the test results did not follow the lab's policy.
(The lab was using a 100 ng/ml calibrator and the determination of whether the specimen was positive at the 50 ng/ml cutoff level required a manual review.)
In addition to counseling the scientist, the lab installed new screening instrumentation that will allow a " simultaneous determination of the 100 ng/ml and 50 ng/mi cutoffs without the need for a manual review / calculation of the data."
(Enclosure 3)
false negative blind performance tests by LabCorp.
In the first case, NYPA said LabCorp submitted "an improperly certified report... indicating that the results of the initial screening of the specimen were negative." When contacted by the Medical Review Officer (MRO), LabCorp said the report was g
g incorrect and that the tests had not been completed.
LabCorp subsequently submitted a corrected, signed, certified report saying t se mng 4
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Dr. Donna Bush '
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positive for phencyclidine.
In the second case, LabCorp notified the MR0 by teleprinter that the specimen was negative with the exception that:
" drug analysis not performed for Cannabinoids. Please contact laboratory."
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The MRO immediately contacted LabCorp and, within hours, LabCorp sent a
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corrected report saying the specimen had tested positive for cannabinoids.
The investigation concluded that " poor worker. practices" had caused both errors: an incomplete report was sent before the lab's confirmatory testing was completed on the first specimen and, although the second specimen had been accurately screened for cannabinoids, a clerical error in reading the test results caused an incorrect report to be submitted.
LabCorp made several changes to their procedures and their custody and control form.
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NYPA will monitor the LabCorp reports closely.
(Enclosure 4)
- 5. Duke Power Company letter of November 25, 1996, reported one false negative 1
blind performance test for amphetamine by SmithKline Beecham Lab, Atlanta.
A few months earlier, the lab had replaced their Olympus AU5000 screening instruments with new AU800 instruments and validated the new AU800's using d-methamphetamine calibrator and control materials. The d-amphetamine i
reactivity was not checked, however, because the response was believed to be equal for both d-methamphetamine and d-amphetamine. The investigation l
found that, while the AU800's responded appropriately to d-amphetamine, the.
j-response was variable. The lab concluded that the error probably resulted j
from this variability in d-amphetamine reactivity and, accordingly, began including d-amphetamine in one of their batch controls.
(Enclosure 5) 4 10, 1996, reported a result over i
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- 6. Framatome Technologies letter of December 30 percent below the expected range for a blind proficiency specimen tested by American Medical Labs of Chantilly, Virginia. The screen was positive, i
and correctly reported positive, for morphine and codeine at 420 and 410 ng/ml, respectively (the values should have been 699 and 698 ng/ml). A repeat GC/MS found 685 and 654 ng/ml. Quality controls were near the mean on both assays.
The investigation found no obvious causes and concluded that the error was random.
(Enclosure 6)
If you have any questions, please call me at 301-415-2944.
Sincerely;
/ original signed by: /
Loren L. Bush Reactor Safeguards Branch Office of Nuclear Reactor Regulation
Enclosures:
As stated DISTRIBUTION:
J.Cunningham L. Bush E.Koup C.Hendren Central Files PDR PSGB r/f DOCUMENT NAME:
LTR2NIDA.015 To receive a copy of this document, indicate in the box:
"C" - Copy without attachment / enclosure, "E" = Copy with attachment./enclog re, "N" = No copy 0FFICE PSGB:NRR E
PSGB:NRR IN BC:RSGlbMKif [ ]
l NAME CHendren /j W LBush Ba JC6nnagf>knAi DATE 02/ 11 / 97 02 / /( / 97 02//g / 97
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