ML20082C131
| ML20082C131 | |
| Person / Time | |
|---|---|
| Site: | Grand Gulf  |
| Issue date: | 07/08/1991 |
| From: | Cottle W ENTERGY OPERATIONS, INC. |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| GNRO-91-00115, GNRO-91-115, NUDOCS 9107180047 | |
| Download: ML20082C131 (7) | |
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e W. T, Cottle July 8, 1991 U.S. Nuclear Regulatory Commission Mall Stat. ion P1-137 Washington, D.C.
20555 Attention:
Document Control Desk Subjects Grand Gulf Nuclear Station Unit 1 Docket No. 50-416 License No. NPF-29 Fitness for Duty (FFD) Unsatisfactory Performance Testing GNRO-91/00115 Gentlemen:
On June 7, 1991, the Fitness for Duty (FFD) Section at Grand Gulf Nuclear Station received a laboratory report from their confirmation laboratory, Doctors and Physicians Laboratory (DPL) in Leesburg, Florida showing that a positively-spiked blind performance specimen was declared negative.
In accordance with 10CFR26, Paragraph 2.8e(4), an investigation was conducted into an unsatisfactory performance testing result.
On June 10, 1991. Entergy Operations requested DPL to investigate the circumstances of this incident (Attachment 1).
On June 24, 1991 DPL replied that the sample had initially tested positive for opiates by immunoassay but was below the confirmation threshold of 300 ng/ml by Gas Chromatography / Mass Spectrometry (GC/MS) (Attachment II).
DPL stated that the sample provided to them was positive for morphine at a concentration of 221 ng/ml.
Reanalysis by GC/MS on June 6, 1991, gave a concentration of 236 ng/ml.
DPL did not take any corrective actions after their investigation because they concluded that they had properly and accurately tested the sample and that it fell below the threshold value.
In addition to the above action, GGNS Fitness for Duty Security Personnel referred the Unsatisfactory Performance Testing (UPT) to the Department of Health and Human Services (DHHS) on June 12, 1991 via Dr. Walter Vogi of the National Institute of Drug A3use (NIDA).
Dr. Vog1 indicated that no investigation should be necessary due to this being the first incidence of UPT, the percentage of UPT being so small, and because DPL had confirmed their initial test results with Gas Chromotography/ Mass Spectrometry (GC/MS).
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July 8, 1991 GNKO-91/00115 page 2 of 4 Thn GGNS FFD section had previously measured the blind performanco sample with their Abbott TDX equipment using Fluorescence Polarization Immunonway technology and determined that it was greator than tho 300 ng/ml threshold.
A representative from BioRad, the supplying company of the blind performanco specimen, stated that this sample was constituted with opiate metabolites to show a concentration of 407 ng/ml when analyzed by GG/MS.
The cause of the unsatisfactory performance test is inconclusivo.
Two other blind samples submitted at the same time as'the subject falso negativo sample were both found to be positivo as expected. DpL's invnstigation did not indicate any process problem.
This is the first incidence of falso negativo reporting by this laboratory since GGNS began submitting specirnens in February, 1990. GGNS has submitted 87 blind samples to the laboratory as of June 1, 1991.. Two other drug testing facilities operated by v.ntergy Operations havn not had any unsatisfactory performanco testing results, including opfate analysis, while using DpL.
One factlity (Arkansas Nuclear Ono, ANO) had sent a similarly spiked sample from this samn blind lot to Dph and received sentisfactory results.
Because this appears to be an isolated incident, no further actions are deemed neoessary at this tien.
GGNS will continun its blind performance testing program with the -labora.ory and carefully moni'ar and t rend its performanco.
Addit lonal. blind samples containing opf ates will be sent to Upl. for t esting.by August 15, 1991.
If you have any questions regardiug this matter please contact Mr. paul Speyerer, FFD Goordinator at (601) 437-2481.
You s trul,
W W'i. NR/mtc altachments: 1.
Letter, Medical Review Officer 2.
Letter, Investigat.fve Findings of 92-4392 3.
GGNS FFD Report of Investigation cc:
(See Next Page)
G9106281/SNLIGFLR - 2
July 8 1991 GNRO-91/00115 Page 3 of 4 cc:
Mr. D. C. Illutz (w/n)
Mr. J. l.. Mathis (w/a)
Mr. R. 11 McGehee (w/n)
Mr. N. S. Reynolds (w/n) dr. II. I.. Thomas (w/o)
Mr. I'. W. Titus (w/n)
Mr. Stewart D. T.hneter (w/n)
Regionn1 Arlministrator U.S. Nuclent Rogulatory CommissAon Region i1 101 Marietta St.,
N.W.,
Suite 2900 Atinntn, Georgin 30323 Mr L. l.. Kintner, Project Mannger (w/n)
Office of Nuclent Ronctor Regulation U.S. Nuclent Regulatory Commission Mail Stop 11D21 Wn.hington, D.C.
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June 10, 1991 Dr. Thomas Tecluzen. MD.
Dr. Michael Shaffer, Ph.D.
Doctors and Physicians Laboratory 801 East Dixie Avenue Post Office Box 491100 Lensburg, Florida 34749 1100 i
CEXO91 00260 Gentleman:
On 5 29 91, the Fitness for Duty Section (FFD) sent several urine speci aens to Doctors and Physicians laboratory (DPL) for drug screening.
Among the samples in the group was a BioR.d blind performance sample that was certified to be positive for opiate rnetabolites at our threshold Icvel.
On 6 7 91, DPL sent results back to the FFD section stating the sample was negative for any drug metabolites (See Attachment).
Because this is an unsatisfactory performance testing result, the Nuclear Regulatory Commission's 10CFR 26 requires that we ask DPL to conduct an investigation into how this occurred and how DPL will take action to prevent future events from occurring. Doctors and Physicians Laboratory shall furnish the FFD section with a record of the investigative findings and the corrective actions taken by your laboratory. This record shall be signed by the individual (s) responsible for the day to-day management and operation of the laboratory.
We ask that you complete your investigation within two weeks of receipt of this letter so we may report your findings to the NRC.
Sincerely W
Dr. James V.
Ervin, Medical Review Officer JWE/jmb attachment / enclosure cc:
C. A. Ellis H. L. Reed W. T. Cottle Central File Corporate File
A t t achraen t 11 A
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June 20, 1991 James W.
- Ervin, M. D.
j hedical Reviev Officer Entergy Operations, Inc.
P. O. Box 756 Port Gibson, MS 39150 i
RE:
Investigative findings of 92-4392 1.aboratory Accession 80897114 Dear Dr. Ervint Pursuant to your letter of 10 June 1991, we are forwarding to you the result of an investigation into the above referenced matter as part of your FFD program.
Sample 92-4392, Entergy Operations S.I.D. number 4889 was received into the laboratory on 30 May 1991.
It was logged in and given a laboratory accession number of 0897114.
An aliquot of this sample was submitted to FPIA analysis on 30 May 1991.
The result was a positive number for the opiate classification.
The sample was then aliquoted for GC/MS on 31 May 1991.
The results of the GC/MS analysis were positive for morphine at a concentration of 221 ng/ml.
Upon receipt of information regarding this sample's status as a proficiency cample, on 9 June 1991 the sample was re-aliquotted for analysis by GC/MS.
The results of that analysis demonstrated a morphine concentration of 236 ng/mi.
The initial test, although positive by FPIA resulted in a morphine level that was belov our GC/MS cutoff for opiates of 300 ng/ml.
weam w htie. M o Thomos u techmos Mihe f acts as mentioned above are a true and accurate representation of the results on file in this office, oip3 mom Amencon I am sorry for the incenvenience that this may have caused you.
Re pectfully a b;M1 d,
SR Michael I. S affer, Ph.D., D.A.B.F.T.
DOCTORS & PH LABORATORY, INC.
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Post Omce Box 490139 e teosburg Florkt M7494139
- 904-787 9006 e Fac 904-365-2869
- 801342-9520
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&ENTERGY
-;--;- OPER A110N REPORT OF INVESTIGATION 2 xxx stuct wIcmr W4 N1 0D8-003-91 unnotief rxtory rerf u mance Testi"9 10Cf R26 Appendix A Re vite und, Lk ense. Diind Poragroph 2-8(e)(4)
WL re formanc e Test n oted<,..
7-3-91 u sTi % 7TO Poul Speyerer - FFD Coordinator sunn This investigation was predicated upon receipt of a negative test on a Blind Performance specimen, #4689, from Doctors and Physicions Laboratory (DPL) on 6-7-91. Dr J. Ervin, Medical Review Officer, directed or. investigation be conducted by DPL to determine the cause of the negative test results.
DPL reported they reexamined the specirnen and found that it was below the the cut-off level for GC/MS. DPL reported that the first onalysis was initially positive for opiates by immunoossoy but subsequent analysis by GC/MS f ound the specimen to read 221 ng/mi for morphine, which is below the 300 ng/ml cut-of f level. Upon r etest the specimen initially tested positive again but read 236 ng/ml by GC/MS. The investigation is unclear cn, to why the specimen tested below the 300 ng/mi cut-off level at DPL.
P. Speyerer, ffD Coordinator, contacted Dr. W. Vogl, o NIDA toxicologist for the DHHS for information concerning conducting on investigotion into the unsatisf actory blind performance testing result. Apprised of the situation, Dr. Vogi stated that the confirmation laboratory appears to have acted corr ectly and that the DHHS does not normally investigate occasional f alse negative like this circumstance.
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A t t acl. men t 111 page 2 of 2 l
MIAlLS JUNE 7, 1991 Blind Performance specimen # 4889 is reported to CCNS as negative. David Lovd FFD laboratory technician, called DPL and requested reantdys,is of the sample.
JUNE 10, 1991 Medical Review Of ficer Dr. J. Ervin sends DPL a request to investigate the occurrence.
JUNE 12, 1991
- p. Speyerer, FFD Coordinator, called Dr. M. Schaffer, Toxicology Director for DPL, and asked about the results of the reanalysis of the blind performance sample. Schaffer reported that the reanalysis of the sample showed opiate level approximately the same as the original level.
Schaffer said that both samples had initially tested ositive by immunoassay but were under the 300 ng/ml threshol by CC/MS Speycrer called Dr. V. Vogl, a NIDA toxicolorist for the DlHIS, for inforrnation on conducting an investigation into the unsatisfactory blind perfortnance testing results. Apprised of the situation, Dr. Vogi stated that the confirmation laboratory (DPL) seems to have acted correctly in their analysis of the sample. Dr. Vog1 stated that the problem seemed to be with the sample itself, and that the DlulS does not norrnally investigate occasional false negatives like this circumstance.
Speyerer enlled. J. lloward, a t echnical spe;cialist for the supplier of the blind sainple (BioRad), and asked if the cornpany had experienced any problems with the stability problems with their opiate blind performance specimen, lloward reported that the company had not and that this particular sample lot was constituted to read 406 ng/ml on GC/MS when analyzed.
JUNE 24, 1991 GCNS received a letter from Dr. Schaf fer of DPL explaining their analysis of the blind performance sample. There were no unusual findings.
JUNE 28, 1991 Speyerer received information froo FFD section at Arkansas Nuclear One showing that they had sent an opiate blind perfortnance sartple to DPL on June 25,1991.
This sample was f rom the same lot as the sample f rom GGNS. The GC/MS results from DPl. showed that the sample contained opiates (morphine) at a concintration of 462 ng/ml.
JULY 3, 1991 Speyerer called Dr. L. Ilovard, Director of Toxicology and Forensic Science at Colorado Springs Police Department Crime Laboratory, and apprised him of the situation.
Dr. Iloward stated that DPL seems to have analyzed the sample and reported the results correctly.
Because DPL accurately analyzed the opiate sample sent by ANO, lloward felt that the problem existed with the sample, not the laboratory analysis. Dr. Ilovard could not give a confident explanation as to why the sample lost its opiate concentration.
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