ML18057A250

Forwards Investigation Rept Re Unsatisfactory Performance Testing of Fitness for Duty Program Blind Performance Test Samples

ML18057A250
Person / Time
Site:	Palisades
Issue date:	05/29/1990
From:	Johnson B CONSUMERS ENERGY CO. (FORMERLY CONSUMERS POWER CO.)
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9006050408
Download: ML18057A250 (10)

Text

consumers Power POWERiNii MICHlliAN'S PROliRESS General Offices: 1945 West Parnall Road, Jackson,' Ml 49201 * (517) 788-0550 May 29, 1990 Nuclear Regulatory Commission Document Control Desk Washington, DC 20555 DOCKET 50-255 - LICENSE DPR PALISADES PLANT -

UNSATISFACTORY PERFORMANCE TESTING OF FFD PROGRAM BLIND SAMPLES Please find attached to this cover letter an investigation report concerning unsatisfactory performance testing of Fitness For Duty Program blind performance test samples. Included in the report is a summary of events which specifies the contributing factors to the erroneous test results and Consumers Power Company's continuing investigative actions, two reports from our Fitness For Duty NIDA approved Laboratory, plus letters to and from our Medical Review Officer concerning the subject.

This event is reportable per 10 CFR 26 subpart B 2.8(e)(4).

Brian D Johnson Staff Licensing Engineer CC Administrator, Region III, USNRC NRC Resident Inspector - Palisades Attachment

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ATTACHMENT Consumers Power Company Palisades Plant Docket 50-255 UNSATISFACTORY PERFORMANCE TESTING OF FFD PROGRAM BLIND SAMPLES May 29, 1990 8 Pages OC0590-0028-NL04

EVENT

SUMMARY

On March 18, 1990, Consumers Power Company's Fitness For Duty NIDA approved Laboratory, submitted an erroneous report on one of the blind performance test samples. The blind specimen #31466, contained PCP, however, Laboratory results submitted to our MRO identified the specimen as a negative test result.

REASONS FOR THE ERRONEOUS TEST RESULTS Based upon the content of attached reports from our Fitness For Duty NIDA approved Laboratory dated March 30, 1990 and April 27, 1990, we believe the following factors could have contributed to erroneous test results:

1. Low level of PCP in the blind sample may have deteriorated prior to reaching the NIDA laboratory.

2. The Laboratory providing the blind specimen, may not have spiked the sample with 56 ng/ml as reported.

3. Our NIDA Laboratory may have been solely responsible and corrective actions as outlined in Attachment 4 may be sufficient.

CONTINUING INVESTIGATIVE ACTION

1. Quality Assurance audit of the NIDA Laboratory will include a toxicologist on the Audit Team and this entire issue will be part of the audit scope.

2. Quality Assurance will contact other utilities who use the same Laboratory as their blind specimen provider. If similar problems are occurring at these utilities, QA will conduct an audit of that Laboratory.

OC0590-0028-NL04

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Medical Foundation, Inc. APR 2 1990 Corporate s~1~.y aml Health Dept.

530 North Lafayette Boulevard South Bend, Indiana 46601-1098 Sr Secy _ _sv_s Asst_

219-2344176

• Elkhart 294-1519 Indiana 800-544-0925 -Secy-CS&H_ _File -

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March 30, 1990 Ms. Judy Smith Consumers Power 212 West Michigan Avenue Jackson.Ml 49201

Dear Ms. Smit.h:

RE: SPECIMEN NO. 31466 The South Bend Medical Foundation received a urine sample on 3-13-90 from Consumers Power Company, identified as Control Number 31466, for forensic drug testing in accordance with Nuclear Regulatory Commission guidelines.

This sample was assigned the internal control number AFT-12488 and submitted to standard forensic urine drug testing protocol.

Aliquots of this specimen exhibited a delta-absorbence greater than the calibrator cut-off of 25 ng/ml PCP, on both initial and subsequent secondary testing utilizing EMIT methodology.

Gas Chromatography/Mass Spectrometry confirmation following positive PCP EMIT screening, demonstrated the presence of the chemical PCP (phenylcyclohexylpiperidine) at a quantitative level of 22.25 ng/ml. This drug confirmed.as being present;.however, the quantitative level was below the administrative cut-off level of 25 ng/ml for declaration of a positive PCP urine test. A result of negative for all tested drugs was reported on 3-18-90 for this sample.

Information received through Consumers Power Company indicates this specimen (Control No.

31466) was a blind sample submitted as part of the internal blind quality control program as dictated by the Nuclear Regulatory Commission, with a target result to indicate PCP positive.

Review to rule out possible laboratory analytical problems has been subsequently performed in response to iiie aforementioned Information. Review of open quality co;;trcl PCP sampias, blind .

quality control PCP samples, QC samples within the GC/MS run containing the test sample, and recent National Institute on Drug Abuse Proficiency Testing PCP results has been performed.

Testing results for these samples have been satisfactory, with established acceptable target values being quantitated.

At the present time, no corrective action is warranted following analytical review of PCP drug testing. This sample tested negative for PCP utilizing NIDA-NRC cut-off guidelines; however, did exhibit the presence of PCP at a level just below the established cut-off. Explanations for how this might have occurred include: *

1) Target value spiked just above the cut-off by QC sample vending laboratory, which may routinely test negative by a second laboratory, with both laboratories performing proper analysis (NIDA recognizes acceptable variances between laboratories, usually in the range of up to+/- 20%).

Attachment 1

2) Specimen degradation due to aging, non-ideal storage conditions, heat, cold, etc.

3) Actual spiked level of sample below target value reported as being associated with testing sample.

To further investigate the above results, it would be helpful for the laboratory (South Bend Medical Foundation) to be provided with the actual quantitative target levels for all PCP positive samples which have been reported for this year, as well as the reported target value for the sample submitted as Control No. 31466. This would allow further investigation of any potential analytical problems or quantitative bias within the testing parameters.

!fd~t-0 Scientific Director C*epartmen~ of Forensic Tox!cclogy RLH/md

Attachment 2 consumers Power l'flWEIUll&

llllUllGAll'S ,,..llESS General Offlcn: 212 Welt Mlchlg11n Avenue, Jackson, Ml 49201 * (617) 788-0550 April 3, 1990 Thomas F Allen Healthcare Directions 300 Roosevelt Holland, MI 49424 RE: BLIND SPECIMEN ANALYSIS ON CHAIN OF CUSTODY 131466 The attached letter describes South Bend's results from an initial investigation made into the inaccurate reporting of Blind Specimen 131466. Please note South Bend's request for the actual quantitative target levels for all PCP positive samples as well as the level for Specimen 131466.

me on all correspondence involving this am required to submit all data to the NRC ys.

u th A Smith Fitness For Duty Administrator JAS: 122-90

Attachment 3 HEALTHCARE D I R E C T I O N S - - - - - - - - - - - - -

Aprl:l 16, 1990

.Judith Smith Consumers Power Company 212 West Michigan Avenue

..Jackson, MI 49201

Dear .Judy:

I talked with Dr. Hover or South Bend Medical Foundation on April 4, 1990. The subject was the ralse negative report on a blind specimen. I gave him the rollowing inrormation:

1. Eight blind specimens containing PCP were submitted (on three dirrerent dates) rrom the same batch.

2. According to El Sohley Lab (supplier or the blinds) each contained 56-ng/ml.

3. Seven or the eight were reported positive to the M.R.D.

4. One was reported negative.

As or this date I have heard nothing more rrom Dr. Hover.

Sincerely,

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Tom Allen Vice President TA:br

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_Legal P.O. Box 4025 300 Roosevelt Northbrook, IL 60062 Holland, Ml 49423 312-564-5200 616-399-9009

L. N. GALUP. M.D. Attachment 4 Presirtent M. G. QUINN. M.D.

Execut1~e Vice. President

l. k HUSSEY. M.D.

South Bend R. E. HARMAN, M.D.

• T. J. EBERTS, M.D.

Medical Foundation, Inc.

W. J. KALINEY. M.D.

F. A. DEOGRACIAS, M.D. 530 North Lafayette Boulevard South Bend, Indiana 40001-1098 R. J. TOMEC. M.D.

D. l. JENTZ. M.D. 219-2344176

• Elkhart 294-1519 Indiana 800-544-0925 A. CARDENAS, M.D.

R. L. HOOVER, M.D.

K. M. JACOBS, M.D.

Diplomates. Ameflcan Board of Pathology April 27, 1990 MAY 11990 Corporate Sal~lf <J11d rleaith Dept.

Ms. Judy Smith Sr Secy Sys Asst

-Secy-CS&H - Fi I e -

Consumers Power

- Secy Med - TOSS 212 W. Michigan Avenue Jackson, MI 49201

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- -Legal RE: FINAL REVIEW I SPECIMEN NO. 31466

Dear Ms. Smith:

In reply to our letter of March 30, 1990, the South Bend Medical Foundation Department of Forensic Toxicology was informed of the target value for the blind quality. control PCP (phenylcyclohexyl piperidine) positive sample, identified as Control Number 31466. Additionally, to further evaluate the problem of a reported false-negative in respect to Control No. 31466, seven (7) additional PCP positive blind quality control samples which had been . forwarded to SBMF were identified.

Results for EMIT-GC/MS testing are as follows:

(;QntrQl ND. QCLMS QJ.rnntitati Dn Rs.<DDrts.<d Rs.<sYlts

• 31466 22.25 ng/ml Negative 31465 44.3 ng/ml PCP Positive 23448 44.9 ng/ml PCP Positive 23441 . 45.l ng/ml PCP Positive 32030 42.2 ng/ml PCP Positive 32040 44.6 ng/ml PCP Positive 32105 45.2 ng/ml PCP Positive 45662 45.8 ng/ml PCP Positive

• - Reported False Negative The vending laporatory providing these specimens indicated their laboratory quantitation of 56 ng/ml for all of the above specimens, which all resulted from the same preparatory batch. Excluding the sample identified as Control No. 31466, the additional seven (7) samples exhibited a range of 42.2 ng/ml to 45.8 ng/ml; a mean of 44.6 ng/ml; a Standard Deviation of 1.15 ng/ml; and a Coefficient of Variation of 2.58%.

• South Bend Medical Foundation, Inc. is a Not-For-Profit Organization

Attachment 4 Ms. Judy Smith April 27, 1990 Page Two Following evaluation of provided specimen results and quantitations, further examination of generated GC/MS data for Control No. 31466 was performed.

Examination of extracted ion data for ion mass 205 amu for PCP internal standard demonstrated an abundance ranging from 2,100,808 to 3,133,410 on standards and controls. The abundance for the internal standard ion mass of 205 amu on Control No.

31466 was 4,469, 173, more than twice the value for the calibrating standard. This data, in conjunction with the reported quantitation of 22.25 being nearly exactly 50%

of the mean for the other seven (7) PCP samples, indicates a probable error in the delivery of the internal standard to Control No. 31466 during sample GC/MS preparation. Review would suggest the sample was delivered two (2) separate deuterated internal standard aliquots. This, in effect, would double the area of the internal standard, and reduce the quantitation of the patient (donor) sample by a factor of 50%.

Due to variation in the extraction procedure, however, this perceived error cannot be determined with any degree of absolute certainty. GC/MS runs will not infrequently exhibit wide fluctuations in internal standard ion abundances even greater than that seen with this PCP problem and still remain within proper analytic parameters. One alternate explanation to this problem although in our opinion one which is less likely, would be specimen degradation of Control No. 31466 due to non-ideal storage conditions. Alternatively, specimen contamination or improper individual specimen preparation might* have occurred.

In response to the reporting of a probable false negative result for Control No.

31466 due to an error in internal standard delivery to the specimen during preparation for GC/MS, the following procedure steps have been performed or adopted:

1. Corrective counseling with the GC/MS technician who performed the probable error.

2. Notification of all GC/MS technicians of error, to forewarn of its potential to occur.

3. Adoption of laboratory standard operating procedure to require no interruptions by additional duties, telephone, etc., for GC/MS technicians during GC/MS sample preparation steps requiring addition of reagents or standards.

4. Adoption of additional Forensic Review process to include examination of absolute and relative internal standard abundances in reference to the calibrating standard, to evaluate extraction variabilities and identify, in the future, any possible similar error which could result in incorrect sample quantitation.

Ms. Judy Smith Attachment 4 April 27, 1990 Page Three

5. Evaluation of possible visual detection system, i.e., colored indicator dye such as safarin at high dilutions added to internal standard working solution, to demonstrate when internal standard has been added to sample by change from a colorless to a minimally visually colored appearance.

We appreciate Consumers Power Company's information and cqoperation with the laboratory in evaluating the discordant results for specimen No. 31466. If further information or clarification is required, please contact me.

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Rick L. Hoover, M.D.

Scientific Director Department of Forensic Toxicology RLH/lsh