ML20062M535
| ML20062M535 | |
| Person / Time | |
|---|---|
| Site: | Cooper  |
| Issue date: | 12/27/1993 |
| From: | Horn G NEBRASKA PUBLIC POWER DISTRICT |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| NSD931200, NUDOCS 9401070260 | |
| Download: ML20062M535 (7) | |
Text
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COOPER NUCLEAR ST Alton Nebraska Public Power District
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l 4-NSD931200 December 27, 1993 U. S. Nuclear Regulatory Commission Attention: Document Control Desk Washington, D. C. 20555 Centlemen:
Subject:
Report of Fitness-For-Duty False Positive Test Result Cooper Nuclear Station, NRC Docket 50-298, DPR-46 The Nebraska Public Power District (District) hereby provides a report concerning its investigation into a false positive drug test result.
The false positive test was identified during the appeal process initiated by the affected District contractor as the result of the initial positive drug test finding.
This report was requested by Mr. Loren Bush (NRC) during recent
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discussions with District personnel.
10 CFR 26 Appendix A requires the prompt reporting of false positive test results occurring during the administration of a licensee's Blind Performance Testing program.
10 CFR 26 Appendix A provides no guidance regarding the reporting of an actual false positive drug test result.
Notwithstanding the absence of requirements to report this event, the NRC Staff requested the District to submit a report of the event to determine possible generic significance, and possibly, for referral to National Institute of Drug Abuse (NIDA) for further evaluation.
t Accordin5 y, enclosed is a report of the District's evaluation of the false 1
positive event.
It should be noted that this " false positive" drug test result did not occur as a consequence of laboratory error;- rather, as a result' j
of a series of events leading to the District's contractor failure to specify and the Medical Review Officer's (KRO's) failure to identify over-the-counter medication apparently. causing the positive test results. The enclosed i
evaluation was performed by the District's Quality Assurance Department.
Please note that the recommendations provided therein are still under l
evaluation. Additionally, enclosed are copies of news updates provided by the District's testing laboratory to inform MRO's of various possibilities for positive drug test results based on the legal consumption of various over-the-counter and prescription drugs.
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U. S. Nuclear Regulatory Commission F".
December 27, 1993-Page 2 of 2 Please. contact me if you have any questions, or require any additional information.
Sinc ely, C-
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resident - Nuclear Enclosures cc: NRC Regional Administrater Region IV Arlington, TX NRC Resident Inspector.
Cooper Nuclear Station i
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NEBRASKA Punue POWER Disrarcr VAD930710 September 21. 1993 V. L. Wolstennoim FOR INTER-DISTRICT To BUSINESS ONLY D. R. Robinson y
Independent Evaluation of False Positive Fitness For Duty Report aubject The purpose of the subject evaluation was to determine the circumstances wnich led to the false positive report and identify any recommended changes to tle pegram or processes to prevent future occurrences. The evaluation was performed during the September 16-20 period of time and included review of the applicable 51es held by NPPD Corporate Security, Clinical Reference Laboratory and the Medical Review Officers (MROs). Interviews were also conducted with the MROs, CRL personnel and Corporate Secunty personnel.
My conclusion concerning this incident is that everyone involved acted in accordance with established Distnct programs and procedures throughout and that everyone involved made all decisions in good faith using the information available to them at the time.
As a result of this evaluation the following recommendations are provided for consideration.
1.
The Distnct's Fitness For Duty Program process for testing hydrated (dilute) samples l
be reevaluated. Specifically, it is recommended that Corporate Security management, NPPD legal personnel, and the MROs evaluate the policy for retesting hydrated samples. It appears that the District's program requirements are very conservative when compared to other utilities and go well beyond current regulatory requirements.
I This review should also address reporting of test results as positive for samples identified as containing levels of drugs which are below the established cut-offlevels.
2.
The District's policy should be changed to require type testing of samples found to be positive for amphetamines / methamphetamine. This would assure all possible sources of the drug are Know to the Medical Review Of6cers during their review and evaluation of test results.
EVALUATION DETAILS Through interviews and record reviews the following sequence of events was established.
In late July of 1993 the individual involved provided a specimen as a result of being selected for random testing. The consent form for this specimen indicated that the subject was I
taking M APOP (a generic form of Tylenol available over the counter), Tylenol, Advil, and PSEDDO 61 P51 caplets for Zephrez LA (prescription). This specimen screened negative for the District's panel of drugs, but was identi5ed as being outside acceptable ranges for Specific Gravity and Creatinine. Both results were below acceptance criteria limits. These results indicate that the sample was dilute from the subject ingesting larger than normal amounts of fluids, thus diluting the sample through fluid intake. As a result, and in accordance with FFD Program requirements, the MRO directed Corporate Security to obtain a second specimen.
In late July of 1993 the second specimen was collected. The consent form for this specimen listed the same drugs as those identified on the previous specimen. This specimen also
- Powerful Pride in Nebraska
QAD930710 September 21,1993 Page 2 of 3 screened negative but again tested low for Creatimne. :ne MRO azain directed a retest based on the low Creatinine level identified.
in early August of 1993 the third specimen was collected. As required by the FFD program, this specimen was consider a for-cause test and, therefore. 'was a witnessed collection. In addition to the previously listed drugs, the subject also listed Ventolin Z-max.
Pheneygan E Codeine, and PS ERCB 61 P51 capletsjail are prescription medicationsh MAPOP was no longer listed as being taken. This specimen also screened negative and again came up as low for both Specific Gravity and Creatinine.
Based' on the third consecutive sample indicating hydration, and in accordance with the FFD Program requirements, the MRO directed CRL to perform 'a Gas Chromatography / Mass Spectrography test of all three samples to identify any presence of drugs in the District's panel of drugs.
The 6rst specimen was subjected to the GC/MS. This test identi6ed detectable levels of Levorphanol, which is a drug in the opiate family. This result was reported to'the MRO.
The second specimen. when subjected to GC/MS testing, was found to contain detecuble levels of amphetamines and methamphetamine (at approximately 67 and 7 times below established cut-off levels, respectively). These results were also reported to' the MRO.
The third specimen tested negative for all drugs at any level when subjected to GC/MS testing. It should be noted that the GC/MS test for this specimen was completed and reported after the MRO had reported the Erst two results to Corporate Security as positive.
After the required interview with the subject by the MRO the test results were reported to Corporate Security as being con 6rmed positive tests. Corporate Security notified Site Security and the remainder of the process apparently proceeded accordin'g to established program requirements. This evaluation did not include any of that portion of this incident.
The MRO indicated that there was'no medical or other information available at that time -
which would support a medically valid explanation for the Levorphanol in the subject's specimen.
Following appeal by the subject, a sequence of events took place which revealed additional information which eventually led to a reversal of the. original decision and the test results were changed to negative. Some of these events included the following.
The testing laboratory, through discussions with the MRO and their own action determhed that a metabolite of dextromethorphan has an almost identical " footprint" (it appears to be identicalin a graphical representation) when subjected to GC/MS testing as does that of Levorphenol. Through additional testing of the specimens. they confirmed the presence of dextromethorphan in the subjects sample. Discussions with personnel at the lab, the MROs.
and District Corporate security personnel identi6ed that dextromethorphan.is a common ingredient in over the counter liquid cold medications. The MRO identified that in talking to the subject that the subject had been taking such a medication but had failed to list it on -
the consent form. Interviews with CRL personnel determined that the virtually matching footprint is apparently new information. Based on the commonality of dextromethorphan
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O'9930710 x,2tember 21,1993 Page 3 of 3 in over the counter cold medicnions and the limited use of Levorphenol, they no longer plan to report its presence in GC/MS results. The lab director also indicated. in a letter to the MRO, that they plan to pursue this information further and pernaps publish a paper documenting their fm' dings.
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Regarding the amphetamine / methamphetamine presence identified in the second sample, two factors are considered significant. First, none of the drugs listed on the sample collection consent form would be consistent with the presence of amphetamine / methamphetamine, Discussion with lab personnel indicated that a follow -up test on this sample, which was not requested but ordered in error, identined that the drugs present in the sample were of the L-type.
L-type amphetamines are readily available in non-prescription form 'through decongestant inhalers. Consideration should be given to thanging our program to conduct this confirmatory test for any specimen which tests positive for these drugs. It must also j
be recognized that the levels detected in the specimen were well below the established cut-i off level of 1000 nanograms per milliliter. The amphetamine presence was.65.78 times below that cut-off and the methamphetamine detected was 7.31 times below that level. In the interviews with the MROs it was learned that for hydrated samples, they have not established quantitative guidelines for making a positive determination. They did indicate that the detected levels would not present a linear relationship to specific gravity.or-Creatinine levels due to the different ways and times that different individuals metabolize-ingested substances. They indicated that it has been their practice.to make a positive determination for any detectable levels of drugs found in hydrated sameSs unless they can t
v explained medically. It appears that this policy is valid for the presesce of illegal drugs och as marijuana and cocaine, but the policy should perhaps be reconsidered for drugs wilable through prescription drugs.
/hile complete statistical data is not available, interviews determined that several employees routinely provided hydrated samples because of their higher than normal daily fluid intake.
In fact, the :.ubject involved in this incident has a hiswry of providing hydrated samples due to the fact that the subject apparently reut nely drinks twenty or more cans of soda daily.
i Any revision of the policy should also address this matter to eliminate unnecessary testing and associated expenses.
i Should you have any questions concerning the evaluation activities performed,- the conclusic a reached or the recommendations provided. please advise me.
/flE D. R. Robinson Quality Assurance Manager Columbus General Offke i
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..m n F wn.va new CRL NEWS UPDATE TO:
Medical Review Officer Human Resourco Managers, etc.
FROM:
Mark Mages Vice President Laboratory Operation DATE:
July 26,1993
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Effective immodlately Clinical Reference Laboratory will print the following messago on all opiate positivos.
- Morphine positivo samples may be the result of codoino, morphine uso or abuse, or horoin abuse. However, it has been shown that ingestion of products containing poppy seeds may cause a urino samplo to test positivo for morphino."
In order to confirm heroin, a 6 monacetyl/ morphine (6 MAM) test may be requested, at an additional chargo. Poppy seeds contain trace amounts of morphloo rnd codeine, so a donor who consumes poppy seed rolls may produce urine positive for orphine. The metabolito 6-monacetyl/ morphine exists in the urine only as a result oi heroin use.
However, the absence of 6-MA, !s not conclusive for the abstinence of heroin.
In addition Methamphetamino j.R, t reports willinclude the following.
- Methamphetamine positive samples may be the result of over the counter medications, proscription medication, and/or substance abuse."
Should the donor indicato use of an over the counter medication such as Vicks inhalor, an additional test, dextro and lovo isomers (D & L isomors) may be requested to datormine if the medication may have caused a methamphetamino positive. This test will be at an additional charge,if requested.
We are providing those messages to assist you in making a determination of a positivo result. CRL cannot control and takes no responsibility for the inappropriate use of any test results by an employer or information rogarding an individual's prescription / medication history. CRL oncourages its clients to use a Medical Review Officer (MRO) to evaluato and communicato tost results. In vi.
of laws like the Americans wih Disabilities Act, employers should carefully conside.shether proscription / medication information and testing results are being handled in an appropriate manner.
If you have any questions do not hesitato to contact me or your Account Executivo.
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.~w itanstaupapwarmam.... me?ArEessemLs, c n: s s ais m e zu w M J u CRL NEWS UPDATE i
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Medical Roview Officers Human Resource Managers, etc.
FROM:
Mark E. Mageo Vice President Laboratory Operations, CRL DATE:
August 24,1993 Effective immediately, Clinical Reference Laboratory will print messagos on positive reports relating to possiblo over the counter medications, prescription medication and/or substance abuse.
These messages wiI appear on positive reports for barbiturates, benzodiazepinos, mothadone, and propoxyphene. Please see the following messages.
Barbiturato positivo reports will include the following message:
" Barbiturate positive samples may be the result of over tho counter medications, prescription medication, and/or substance abuse."
Bonzodiazepino positive reports will include the fo!!owing message:
"Benzodiazepino positive samples may be the result of prescription medication and/or substance abuso."
Mothadono positive reports willinclude the fo!!owing rnessage:
"Methadonc positive sampfes may be the result of prescription medication and/or substance abuse."
Propoxypheno positivo reports will include the following message:
" Propoxyphene positive samples may be the result of prescription medication and/or substance abuse."
in addition, the fo!!owing messages will appear on positive cannabinoid reports:
" Cannabinoid positive samples may be the result of synthetic drugs umd in chemotherapy post-treatment for nausea and vorniting and/or substanco abuse."
Tho National Cancer Instituto has listed dronabinol and nab!!one, synthetic drugs similar to marijuana, as acceptable agents in chemotherapy post-treatment for nausea and vomiting.
Cocaino rnay be utilized by the medical profession as a local anesthetic during nasal surgery.
For this reason. tho fo!!owing message will appear on positive cocaine reports:
" Cocaine positive samples may resuit from usage as a ' cal anesthetic for nasal surgery o
and/or substance abuse."
The abovo mossages are intended to serve as reminders that one must always validate tho individual's medication claims by VD.ving the prescription. Although marijuana and cocaine are seldom used as medication, such claims shouid be verified by their physician or prescription receipt.
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