ML20023C885
| ML20023C885 | |
| Person / Time | |
|---|---|
| Issue date: | 04/04/1980 |
| From: | Strickler L NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180207 | |
| Download: ML20023C885 (11) | |
Text
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,f J#. i j NUCL E AR RE GUL ATORY COf.itilSSION
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f W. ASHINGT ON D C. 70L%
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c.,, e nj April 4,1980
/7 I O f1Ef t0RANDUM FOR:
Files FROM:
Lawrence J. Strickler, Chief, Investigations -
l Office of Inspector and Auditor
SUBJECT:
NtlCLEAR PHAR!iACY INC. (NPI)
On April 4,1980, the original final Report of Interview of i
dated April 1,1980, was placed in the NPI Statement file. A working copy of this Report of Interview is being placed in the regular case file, along with this me.norandum.
G O
e 830412 PDR 2.515 39.
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.3 REPORT OF ll;TERVID.'
I'.r.
Radiophamacist,i
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_ _ _ _.,.. _, Duke University, Durham, liorth Carolina,
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was interviewed ;' arch 18 and 19,1980, by OIA Investicator Thomas F. Hurney, Jr.,
in roo, 54 of the Econo-Travel !!otel, Durban.
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was originally telephoned by Hurney on :'. arch 14, 1980, and advised his intervie. was desired.,f ~~~: requested to know the nature of the matter and he was infomed that it was desired that he submit to questions concerning a forner e.nployer, Nuclear Phamacy, Incorporated (NPI),
Miluaukee, Wisconsin, about which finn DIA was conducting an investigation of alleged crininal practices.,
advised that he was an " honest person" and inquired if he was suspect.
Hurney responded that he knew nothing about[
that he was only a name and that, therefore,. there L
was nothing known at that time about' him which indicated he could be suspect.
b At the initiation of the interview, the above conversatEon was, essentially, repeated.[ ~~~ 1uas not advised of his rights during the interview, as t
the require.nent did not appear to be present.
He was put under oath and he furnished a signed state.nent, Infor...ation set out in his state.nent is not repeated 1.crein.
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. };aareed to cooperate on the basis that the infornation he furnished was to be used in a criminal prosecution of. PI or in securing reculatory
- sanctions concerning it 'and that-the infor..ation was not to be released except in connection with criminal justice proceedings and/or a regulatory hearing of sc.::e sort.
He explained that he had uarked very closely with I;r. Jon !!. Reivas, the manager of 11PI Milesukee, he bare him no ill will, and he wauld not wish to cause him harm or have him think he had done him ham unless a salutary result was to be accomplished.
In his statement,[ ~ mentioned his dislike for the attitude and practices of i;PI Milwaukee and their potential consequences.
He also advised that he has heard of-similar attitudes and practices in _the nuclear phamacy business and, as a result, he would like to assist in cleaning up the industry.
He explained that he realized that he had done things which were wrong.
So.,e he did, despite the fact he had doubts, because Reivas did them and
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understood they were done in 1;PI and he doubted himself, t.
reasoning that "they" must know better because they've been in the, business, while he was just cut of school.
Others he did as a result of fatigue; he just didn't take the trouble to check and see whether
-they violated regulations or license conditions.
He explained that he worked ninimally 70 hours8.101852e-4 days <br />0.0194 hours <br />1.157407e-4 weeks <br />2.6635e-5 months <br /> a week, sonetimes nach more, especially
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in the bad weather when the drivers might not shor: up and he had to
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deliver and pick up in addition to everything else and as a result, after a s.hile he didn't have much energy, except to try to get through 1
the substance of the tasks in front of hin.
He also explained that his wife was 'quite ill during a a part of this period and spent a month in the hospital.
This caused him to be preoccupied.
advised that there were two hospitals to which ilPI liilwsukee sold bulk Xenon-133, St. liary's and St. Luke's.
The quantities they used, plus the amount fiPI needed for itself were such that on the. day f1PI received its bulk LIC Xenon-133, it would have in its possession for that day more than its license allowed. '
~
2 stated he believed the license
~ limit was 1 1/2 or 2 curies but that they possibly had 3 curies on hand,
r.entioned the following as an exaaple of how frugal they ware at NPI liilwaukee, at the expense of following good phanaacy practices.
They made a great deal of use of saline solution.
li. was a medium into which they put various radio'phannaceuticals, which soluilans were subsequently 3
injected into patients' veins by hospital custo:ners of !!PI.
The cor;.non fonn in which saline solution is parchased and used by ph%rc.acies is in 30 cc disposable vials.
They are quite inexpensive, perhaps $.30 a piece. The idea is that the sterile saline is drawn off with a sterile needle for whate.er use is required.
The vial is then thrown away, with the reaaining saline solution in it.
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i They did not do this at NPI.
Iney reused the 5.30 vial until the,v had drawn all of the saline solution out of it.
I;ot only that, they had refilled the vials to begin with, but not fron a fresh source of saline.
,1 Uhen they had exhausted a technicium gas generator, they took from the center of the generator a reservoir of 500 cc of saline solution.
iadvised that this repeated entry into the 30 cc vials by needles j
being usea for a variety of purposes could have resulted in contamination (with bacteria, other radiophamaceuticals, etc.) of prepa' rations which were to be injected into people's bloodstreams.
This could. result in the negligent adulteration of drugs, which is a violation of state phamacy laws. I
~ '. advised that, although not probable, these things were passible, and the possibility arose from failure to follow generally recognized good practices - in order to save a few cents.
advised that generally speaking the UPI office, including the
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laboratory space, was not acceptably ' clear.
It was an established procedure that one of the collateral duties of the vehicle drivers each day was to take a day's supply of syringes fro.n the manufacturers' sterile containers and leave them in an open tray, exposVd to the air.
The floor went unscrubed for weeks, or possibly months at a time, and it had a great deal of dust and debris on it which was raised when people, wal ked. Contaminated air rose from the floor and had to cover everything, including the opened syringes and whatever the radiophamacists were working on at the noment.
i,'
L:- -.. advised that Reivas instructed that throx-away rubber gloves he rubbed with pawder and reused.
This increased the risks of contamination.
Good practice is to use such gloves once and to discard the:r..
He advised that the required tests care done (wipe tests, air saaples, thyroid tests, etc.).
But they were done at times which could be expected to show favorable results, and they ware. not conducted optimally.
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advised he had nothing to do with selling.
He talked to the hospitals only about orders.
Reivas handled most of the selling.
the HPI Chicago salesman, was fran flilwaukee.
As a
^
i result he came up frequently.
Sonetimes he helped Reivas on the selling, generally on "hard sell" situations where Reivas was having trouble.
In relation to tests on Xenon-133. gas,{]said the following, in
- addition to what is in his stateinent.
NPI ltilwaukee had a-single channel analyzer'(a machine which is like a very sensitive calibrator).
~
It could be used to detennine the nuclidic purity of UC's Xenon-133 gas, but it wasn't.
To put it to such use could simply require iaore time l
than was feasible.
The pyrogen oven, which could be used to insure the freedom of pyrogens from Xenon-133 gas, was never used for that purpose.
'As a natter of fact, the only thing Petry ever saw it used for was to dry P.eivas' wet socks in the winter.
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l confimed that the ordering and recordkeeping was pretty well
-t centralized in llPI. Headquarters.
He advised that he had never knoan a hospital to order Xenon-133 gas other than genericaally.
They generally called up and said they required a dose (or more) of Xenon-133 gas; th'at's all they said.
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advised that the profit was very great in buying and reselling UC Xenon-133 gas as distinct from GE Xenon-133.
He saw, in ilPI records, that tipi was paying $95 to $100 to UC per curie of Xenon-133; it was in 4
turn selling it to hospitals, without even opening the can or doing anything, for $,185 per curie.. At that time, said, he knew from associates outside of liPI and fro:n his own experience in Indiannapolis that GE t:as charging hospitals $250 per curie, stated that they got between 50 and 100 dosage units out of a -
curie (dependent upon decay and whether 10 or 20 millicurie doses), and they pretty routinely charged the hospitals $30 per dose.
So, he advised, it could be seen how great the profit was in breaking down the gas from bulk.
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, _.d advised that. t'iey left the 11: label on the cans of b. sit 'Xhnon-12?
l pas then they sent it to their hospital bulk custo ers.
They added the
- HPI' label to it.
Reivas instructed hin to do this. ' They put_ the syringe
~
label on syringes.
They put the syringe label on the vials at first, but Mt. Sinai Hospital requested that they stop, and they did.
The hospital told them that the label interferred with the operation of the
" gun" which administered the gas.
f was shown a xerox copy of HPI Mihtaukee's " prescription blank,
label and syringe label (copy attached hereto).
He confirr.ed that those labels were in use during his HPI tenure.
He stated that the prescription blank went out with the individual dosage units and with the bulk ship.ments.
It showed 'the Xenon-133 pas was for "pulmanary ventilation study."
I at Reivas' instruction typed this on the prescription
~
Reivas and
' blanks. S bsequently, the prescription blanks came fro:n NPI Headquarters with those words already typed in.
advised that there was only Reivas when he began-at HPI.
A short
. while later, a sec reta ry,b '..a_-
andatechnician,f.__
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L__
were hired.
He advised that;F"
.is a high school teacher who was I
trained on the job.
He believed they are still with HPI Milwaukee.
He advised that, in his judgenent, they would'have limited knowledge of many of the things of which he spoke, due to their having very little l
technical background.
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L 1*dvised that he talked reaular1v to only t.:o peonle at riPI Headouarters:
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~'(!.IW) a clerk who received telephone orders, and her assistant, a L
girl those nane he doesn't recall.
He advised that he did not know I;PI's officials or talk with the:n on the phone. !!r. Sakasitz, a Vice President of T;PI, visited !!ilwaukee three r-
~~~"
He
) did not, or four times during the p5riodlL yas there.
houaver, share in discussions.bstueen Reivas and Sal:asitz during these' visits. He could recall nothing which would indicate Sakasitz was aware that they were refilling vials.
' informed that he never visited any other !!PI offices, nor did he talk regularly on the ' phone with other offices.
However, on one occasion, a radiopharnacist fror, another NPI office did visit in NPI liilwaul:ee for' a week. He was from a Tcxas office, possibly Houston.
He was attending a G.E training course in the area and he visited in the office one or two hours a day.
He'made no adverse co.ndents, nor did he seem surprised by anything they were doing.
He see.ned to be familiar with all procedures, c r'.was busy, he helped,t
.by drawing a and on a few occasions when
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e few dosage units of Xenon-133 gas.
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I Tfurnished the. names of the people with 5:hom itPI dealt at lit. Sinai e :. -
Hospital and St. liary's Hospital. He advised that on a few occasions e(
'the people at Mt. Sinal told NPI the vials >:ere low in radioactive content, perhaps -20% or so.
These stere not co plaints, merely observations.
But they were the only thing that might be considered even slightly n ega tive.. There was no discussion of isssible refills, the condition of the septa, etc.
He advised he recalled no co:nplaints from St. Lukes.
They sold mostly bulk to St. Lukes, one curie at a time.
Sonetimes, in between curies, they sold them so.ne single dosage unit syringes.
Rought draft prepared ilarch 25, 1980.
. k.,e%kn 6 f*
This document reviewed
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.q b
Thomas F. Hurney, Jr.
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