ML20023C890
| ML20023C890 | |
| 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 8305180223 | |
| Download: ML20023C890 (15) | |
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NUCLE AR REGULATORY COMMISSION E
nr.tHINGTON, O C. 205S5 n'
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s met!0RANDUti FOR:
File
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j FROM:
Lawrence J. Strickler, Chief, Investigations'
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I Office of Inspector and Auditor
SUBJECT:
NUCLEAP, PliARMACY INC. (NPI)
On April 4,1980, the original March 19, 1980, statement of
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was placed in the HPI Statement file.
A working copy of this sta,tement is being placed in the regular case file, along with this memorandum.
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8305180223 830412 PDR FOIA EMSHWIL82-151 PDR 3e.
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, having been duly sworn, nake the following voluntary stater.ent to Thomas F. Hurney, Jr., who has identified himself to me as an Investigator in the Office of Inspector and,. Auditor, II.S. !!uclear Regulatory Commission. ll0 threats, force, or promises of re.eard have been used to obtain this statement, and it is given freely and voluntarily.
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, v.ss born in Knox, Indiana,,
currently reside at l
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I have as a radiopharmacist by Duke University been enployed since; fiedical Center, Department of Radiology, Durhan, North Carolina.
Previously I was employed by Nuclear Phamacy, Incorporated (tipi),
liilwaukee, liisconsin, as a radiophamacist fromf through h
_ Prior to that, I was a radiophamacy resident at Indiana
. University lledical Center for a year.
I have a B.S. degree in Pharmacy (1975) and a masters degree in bionucleonics (1977), both from Purdue University.
I am'a registered phamacist in Indiana, Ifisconsin, and T! orth Carolina.
1.' hen I began wi th HPI in Itilwaukee, the office had only been open for about 4 to 6 weeks.
The manager,11r. Jon 'I. Reivas and 3 drivers were the only e1ployees.
Subsequently, t.2 got a secretary and a technician.
lir. Reivas instructed rae in relation to both the substantive functions of the office (e.g., breaking down UC Xenon-133 gas, how to pachage individual doses, etc.) and the' administrative functions (e.g. ordering, record I.eeping, etc.).
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. Shortly after I began working at li?J Mih:aukee, I became concerned over the fact we were breaking down bulk linion Carbide (UC) Xenon-133 gas into individual dosage units for hunan use.
The outer metal container Tne sense of holding the bulk UCampule(s) had a cautionery label on it.
what the label said was that the pas was not suitable for hunan use.
I voiced my concern to Mr. Reivas.
I told him it seer.ed we should not be preparing this for hunan use.
He, essentially, explained away my He said that the only sources of bulk Xenon-133 gas were, UC objections.
He and General Electric (GE) and that GE got its Xenon-133 from UC.
said the only differences between the two was that GE passed the gas through a sterile filter and conducted a radionuclidic test, while UC He stated,that we could do the filtering in our office.
did neither.
He also said that the rest of th'e llPI radiopharmacies were using the UC Xenon-133 gas, that we were not the only ones, so that it must be OK. '
The filtration removes bacteria.
The filter required is 0.22 micron When 11r. Reivas instructed me' how to break down the meabrane filter.
bulk Xenon-133,.he did not use a filter - that was not part of the process he had described. We only ever had a couple of those filters in the office, despite the fact they are quite inexpensive (costing only about $1.50 apiece).
These are disposable items.
I would have expectd that there would have been many of them available.
In my current employment we teep hundreds of them available.
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Despite the f act he said we could filter the IC ).enon-133 cas, *f'.r.
Re.ivas never instructed that we do so, and I have no reason to believe that he did so.
I did not.
The purpose of the radionuclidic test is to insure that the gas is what in this case, Xenon-133.
We never perfomed it is supposed to be such a test on (IC Xenon-133 in i1PI Milwaukee.
1 am not aware that we ever perfonned any kind of test or treatment on this gas.
All of the Xenon-133 we broke down was for hospital custo:ners who were using the gas for lung ventilations for human patients.
Mr. Reivas clearly knew this. We rr.ade up two kinds of unit doses:
syringes and vials, both of which went in a lead " pig" or shield for transportation to the hospital. We put our HPI Milwaukee label on the outside of the These identified pigs and an HPI Milwaukee syringe -label on each syringe.
the gas as Xenon-133. We also prepared an ilPI Milwaukee prescription blank showing that it was Xenon-133 and that it was for " pulmonary ventilation study". A copy of the blank was provided to the hospital along with the pig.
Although I looked at itPI Milwaukee's HRC license several* tines, I did l
not read it carefully.
I simply did not have the time, due to the de:r, ands of the substantive work.
I have been shown a copy of the license.
Upon a reading of license condition #15, it clearly means only one thing td me: that we should not have received or dispensed UC Xenon-133 gas, because it was not indicated for human use.
.I was aware fro.n ny prior i
work experience that UC did not have an HDA.
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Uhen I first began inrking for NPI, we stere petting some bulk Xenon;133 cas from other NP) of fices (I do not recall which ones).
This was because we were just ' starting and hadn't built up a sufficient demand to order full ampules.
This went on. for about a ccuple~of months.
I assure that it was UC, but I don't know. Af te'r that, all of our bulk Xenon-133 gas came from UC.
Uc bought a small amount of "edi-physics single-dosage unit Xenon-133 for the first mor.th or so for a few hospitais, until we converted them to 'our own dosage unit syringes.
After that, we We never bought no single dosage units of Xenon-133 gas from anyone.
received any New England Huclear (NEN) dosage units.
In sucarry, virtually all of the Xenon-133 gas we handled during my time with NPI liilwaukee About 80% of this we broke down to single dosage units for was UC.
i delivery to hospitals. ; The rest we sold in bulk to hospitals, -who would -
in turn break it down.
The reason, in my judgement, we used UC Xenon-13'3 gas was that it was cheaper than GE, very much cheaper.
I was aware of what we paid 'for. it, and 1 was aware of GE's bulk prices fran my previous experience and~ from
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conversations.with non-NPI acquaintances who were knowledgeable, 5
' Mr. Reivas never specifically' discussed this with me, but-he dion't have to - it was obvious.
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.J 1.'e nade nany times more money by breaking it do.en and selling the individual dosaae _ units. to holi, ital s.
I'knov how many dosage units we got from a e
one curie impule and how much we sold; them for.
Again,. it was obvious.
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I believe that we only sold Xenon-133 gas in'vi'als to one customer,
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Mt. Sinai Hospital, Milwaukee.
The vials we used were clear glass 2-milliliter vials with a gray or' red rubber septum and an aluminum crimp seal top.. When we broke dowa an, ampule of Xenon-133 gas, we would fill the required number. of vials at the, tranent for Mt. Sinai Hospital.
The rest of the gas we-put into other vials to await orders.
These we left t
under the laboratory -hood, for venting purposes.
l'did not refill NEN vials, and I am not aware of Mr. Reivas doing so.
When we had nade up a' vial, we put vaseline on the seal so that it woul'd not leak. This included the vials that were prepared for Nt. Sinai;:
although, I wiped a lot of it off before the vials went-out to Mt. Sinai, because of appearance.
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These procedures for breaking down Xenon-133, as well as other pro'cedures s
used at NPI Milwaukee were all nriginally demonstrated to me by Mr. Reivas.
He told me to put vaseline on the vial septas or they would leak.
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The reason they would leak is that we reused then so much.
We possibly penetrated the septa of these vials as many as 100 to 200 tines each.
As a result, the septa were-badly deteriorated; ue put at least 2 holes in each septum each time. we filled a,. vial, but more likely 5, and the hospital put 2. holes in it when they uged it.
We reused the vials until the septum of a vial tore.
In some cases, it broke loose from the crimp seal.
Occasionally, a septum had so many holes in it that it leaked badly even with vaseline on it.
When this happened, we stopped reusing the v'ial.
When a vial -looked so bad.that it might be leaking despite the vaseline, I would recalibrate it.
If it was a leaker, I would discard it. - I also r e. '
occasionally would recalibrate some vials at random to see if they were l eaking. fienerally, I found that the vaseline kept the leaking within acceptable limits.
The vaseline and the fact.that s got the vials to Mt. Sinai Hospital quickly (it was a y 7 to 4 blocks away), in my 1
e vials I worked on from leaking judgement, probably would han 4
to a point where there was a loss of radioactivity sufficient to jeopardize the validity of a lung scan.
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'I do not know whether that was -the situation for the vids Mr. Reivas j
worked on.
Because we worked separately, on different shifts, I do not know whether he spot checked the calibration of the vials he refilled, i
l for leakage - or how carefully he checked the septa.
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I asked Mr. Reivas at least several tines to cet nett vials.
He told me that they had to be obtained from one of the other NPI radiophamacies.
. He said. he would reorder them.
I don't know whether he did or not.
But, we routinely used about 30 of these vials, and we had a reserve supply 'of 5 to _10;.and in the 15 months I was with NPI Milwaukee, the reserve supply was only replaced about 2 or 3' times. ' 5t the beginning, Mr. Reivas told me about the reserve supply:
be careful, that's all that we have.
By that, he meant that we should use them sparingly.
It should be understood that these vials are a very inexpensive item.
I did not see the price for them, but from my radiophannaceutical experience I would estimate that they probably wouldn't cost any more than 20 cents apiece, if that.
In my judgement, it it poor practice to reuse these vials at all.
It is possible that they could be contaminated as a result of system failure when the gas was being administered to a patient; inadvertently in the hospital in a number of ways, after they were used; by carbon monoxide in a leaky trunk of the delivery vehicle, if there was a vaccum in a vial; etc. 'The point is that, once the vials were out%f our control and used, we had no way of knowing what had happened to them. Therefore, we should not have reused them without processing them to insure they were safe for hunan use. We did not do this.
We performed no tests nor did we treat the returned vials in any way. We merely refilled them.
I could not have remedied this situation without the cooperation of Mr. Reivas and equipment ir.d natei-ials which were not available.
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I have been shown by Investigator Hu/ney a statement concerning " Preparation of Glassware and Containers" which he ' advised me was a part of NPI's application for an NRC license and which is incorporated in Condition il7 of NPI's NRC license.
It describes procedures for washing, pyrogen burning, and sterilizing by autoclave of glassware, closures, and containers.
If this is all so, then it means to me clearly that fiPI should not reuse vials without subjecting the components of the. vials to the described procedures.
I would estimate that NPI Milwaukee, during my tenure, dispensed between 5 and 10' single dosage unit vials of Xenon-133 gas a week to Mt. Sinai Hospital.
I was not included on NPI liilwaukee's NRC license until many months after I went to work there.
I do not re:nember the datess During the i
period I was not on the license I routinely' handled and prepared materials covered by the license, tihen Mr. Reivas got around to getting my name included on the license, he handed me some fonns to fill in in connection with applying for my inclusion.
i filled them out and gave them to him.
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I took the !!isconsin State reciprocity pharmac'y examination' in December, 1977 for the first time.
I missed passing by a few points. I took it again subsequently and was' licensed in Wisconsin in June,1978. So, nost of the time I was enployed by i;PI Milwaukee, I was not a registered pharmacist in Misconsin, and I should only have acted as a pharmacist under the direct supervision of a registered pharmacist. This did not happen. Reivas and I worked separate shif ts.
So, most of the time.1 was unsupervised. Reivas told me that since he obviously could not he there that,I would have.to all the time - that is, fran 4:00 am to.5:00 pm -
work alone but that I should _ lock the door so that we sculd appearito be ITnat Mr. Reivas meant was that the radiopharmacy would appear' closed.
to be closed, in order to mislead a Wisconsin State Phannacy inspector.
He told me that 'if an inspector did. ring the bell, I should tell the inspector that we were a't' that time closed (for lunch, for supper,'for whatever) and that I should then phone him (Mr. Reivas).
Mr. Reivas instructed and demonstrated by example that when Iodine-133 capsules were returned by hospitals, they should be re-entered into the inventory (via the log book) and redispensed to other hospital customers.
whenever possible.
I complied with this, as did he.
I regard this as a poor pharmacy practice and believe it is in violation of State pharmacy prohibitions against redispensing phan.aceuticals.
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}n ceneral, the standard of cleanliness of the laboratory on a daily basis was unacceptable for a phamacy of any kind.
Floors were dirty, trash accumulated, rubber gloves tare reused sehen they should not have been, and disposable sterile syringes were removed from the manufacturer's package and stored in the open air (those syringes being for use in the preparation of drugs which were supoosed to be prepared in a sterile a tmosphere).
I mention all of these practices - from refilling vials to dirty floors -
as indirective of an atmosphere which existed during my tenure at NPI Milwaukee.
I regard this atmosphere and attitude as non-professional, as establishing situations there patient care might be compromised, and as representing radiopharmacy in a poor light and as providing poor example to new professionals in the~ field of radiopharmacy.
I have read the above statement, consisting of this page and twenty -
other pages, it is true and correct and freely given.
I have initialed all other pages and all corrections, and I sign this page below.
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t Sworn and Subscribed to before me on March 19, 1980, at Durham, North r.arolina
/s/ Thomas F. Hurney, Jr.
Thomas F. Harney, Jr., Investigator em u
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having been duly sworn, make the following voluntary statement to Thomas F. Hurney, Jr., who has identified himself to me as an Investigator in the Office of Inspector and Auditor, U.S.
iluclear Regulatory Commission.
fio threats, force, or promises of reward have been used to obtain this statement, and it is given freely and voluntarily.
business being at 549 Albany Street, Boston, thssachusetts, phone 617-I have a doctor's degree in chemistry from the University of 482-9595.
I have been continuously employed in ?!Eli since-I have
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~.t iiEli is a processor and distributor of radioisotopes for medical and TiEit has, for at least ten years, processed and distributed c or,mercial use.
He sell it to hospitals an'd radiophannacies.
Xenon-133 gas for human use.
It is used primarily by inhalation for evaluation of the pulmonary function and for imaging the lungs.
We sell it only in a dosage unit form (a 2 milliliter vial containing 10 or 20 millicuries).
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NEN's processing and distribution of Xenon-133 gas is under the regulation of the U.S. Food and Drug Administration (FDA), due to the fact the We operate under a New Drug Application substance is for use on humans.
Our entire methodology for processing the (NDA) approved by the FDA.
substance, in minute detail, is contained in our approved application and approved amendments thereto.
We may not do anything in relation to the substance unless it is approved in one of those documents; if we do, we are in violation of FDA regulations.
We have to enploy very careful We must keep detailed records and be-
- quality control over the process.
We are inspected.
fully accountable for all quantities of the substance.
by the FDA at,least annually.
We must demonstrate our competence to assay the substance, that is to calibrate to a very fine degree how much of the active substance is in each vial at the time of. processing.
In other wards, we are very specifically and minutely regulated in order to insure that the Xenon-133 gas which we put out for human use is efficacious and is processed in a pure environment.
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-3' NE does not refill its Xenon-133 vials.
He use brand new vials, septums, and seals for each dosage unit we process.
We could not refill; to do so, refilling would have to be approved in our NDA, and it is not.
We do not intend that anyone else should refill our vials with Xenon-133 gas, or with anything else intended for human use. We have never indicated to anyone that be could refill our vials.
It is NEN's position that such refilling would be bad pharmaceutical practice. due to the possibility that refilled vials (1) could be contaminated during the refilling, and (2) could leak.
Investigator Hurney has told me that he has been told of situations where such Xenon-133 vials have been refilled.many times, with the septums having received large numbers of needle holes as a result.
It
.is my professional opinion that multi-piercing of septums could result' in degrees of leakage which could be. responsible for faulty diagnosis.
Leakage of sufficient magritude under the wrong circumstances could also contaminate technical personnel and other people.who are sufficiently exposed. to the leakage.
-Investigator Hurney has also told me of his having been informed of a situation there vials were filled with Xenon-133 gas, which vials had been refilled r.any times, and where the vials' septums were smeared with s
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vashline to prevent leakage while they were awaiting being used as 1
dosage units or as the source of refilling other dosage unit vials.
believe that such practice could increase the possibility of contamination of the contents of the vials.
I ha've read the above state..ent, consisting of-this page and six other J
I have initialed all pages. 'It is true and correct and freely given.
other pages and all corrections, and I sign this page below.
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/s/l Sworn and subscribed before me on April 15,1980, at Boston, l'assachusetts
/s/ Thomas F. Hurney, Jr.
Thanas F. Hurney, Jr., Investigator, DIA, NRC
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WASHINGT ON. D C. 70555
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i APR 161980 '
Mr. Julian Greenspun Deputy Chief for Litigation Criminal Division U.S. Department of Justice Washington, D.C. 2D530
Dear Julian:
The purpose of this letter is to provide you with a number of documents not previously furnished to you, which we obtained through our investigatron of Fluclear Phamacy Inc. (NPI).
They consist of statements, reports of interview, memorandums, etc.
To facilitate your review, each of the documents are identified below and following the description of each document, is a brief summary of its content.
As you can appreciate, the -
summaries are narrow and should not be considered all encompassing as far as their total relevan,ce is concerned.
DOCUMEllT 1 February 12, 1980 statement of.
fluclear !!edicine Department, St. Luke's Hospital,'in Iwaukee, wisconsin.
Ms.
states that it was her assumption that when iiPI delivered unit doses of Xenon-133 in NEN vials, the product was, in fact, NENs.
She had no knowledge that the Xenon-133 received from NPI was of commercial, rather than phamaceutical, quality.
NPI knew that St. Luke's ordered Xenon-133 for diagnostic work in. humans and St. Luke's relied on NPI to furnish a product suitable for human use.
NPI's label which stated, in part, that "...This radiophannaceutical is licensed by the U.S. Nuclear Regulatory Commission..."- served as partial assurance to St. Luke's thEt it was receiving a product which met all of the requisit'es for human use.
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February 13, 1980, statement of P-_
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of Nuclear tiedicine, St. Luke's Hospital, Milwaukee, k'isconsin.'
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states that St. Luke's purchased Xenon-133 from NPI for use as a radiophamaceutical to diagnose lung conditions in humans.
It was purchased by St. Luke's pursuant to a license from the NRC.
The Xenon-133 received from NPI was never labeled in a manner indicating it was not for human use.
NPI knew that St. Luke's used the Xenon-133 as a diagaostic d.mg and St. Luke's relied upon NPI to furnish a suitable product.
DOCUMENT 3 March 18,1980 statement of k Registered Phamacist.
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states that~ in/about late August 1979 he was visiting at St.
Luke's Hospital in Milwaukee and toured the nuclear medicine area.
He viewed stocks of unit dose vials of Xenon-133 and all appeared to have
, NEN' labeling.
After examining NEN labeled vials in both the active and waste areas, he concluded that many of 'the vials had been recycled.
The recycled vials displayed clear signs of multiple punctures in their diaphram covers andt claims that repeated puncturing of the diaphram will eventually lead to excessive Xenon-133 leal: age.
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telephone conversations with Memorandum _ of_ F_ebruary_28_and 29,1980, St. Luke's Hospital.
Ms.~ Osaid that for at least several years preceding September 10, 1979,
-all stocks of.X'enon-133 purchased by St. Luke's was supplied by NPI, Milwaukee.
She said that St. Luke's,could provide confimatory documents, if necessary.
DOCUMENT 5 Phamacist.
. February 22, 1980, statement by l
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states that he was employed as a phamacist for NPI from, t
throughj This employment was first in Texas and then in Kentucky (both are agreement states).
While in Texas he was trained by Robert Sanchez, NPI'.s President, in breaking down bulk Union Carbide Xenon-133 and inserting it, for ~ distribution, 'into used NEN vials.
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was sold to hospitals for inhalation studies in humans.
Some documents accompanying the Union Carbide Xenon-133 were marked, in effect, "For research use only.
Not for human use."
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.. questioned HPI's e
distribution of.this product he was told it was safe for use in humans p-and not to concern himself with the matter.
Vials were recycled so many times that leakage became a problem and in a matter of hours some vials were found to have lost up to half their activity, rather than just the few tenths of a millicurie frda nonnal decay.
' stated that if he were a hospital technician and received Xenon-133 in an NEtt vial, he.
would assume the Xenon-133 to be a product of HEN.
He said that breaking i
'down and reselling Union Carbide Xenon-133 was very profitable, much more so than just buying and reselling vials of HEN's Xenon-133.
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Report of February 21 and 22,1980, interview of F 2 * $ M rough drafted on february 27 and reviewed in final on !! arch 7,1980.
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said that when Sanchez (tipi's hresident) told him that Union Carbide Xenon-133 was fit for human use, he had to assume Sanchez was correct. He said that he was new (recently graduated) and assumed that his employers knew what they were doing.
.said that he knew that to be suitable for human use, Union Carbide Xenon-133 had to be approved by the Food and Drug Administration and HRC or state-approved.
Based on what his saployers told him, he assumed these approvals existed.
He also said that in his present employment, with another nuclear pharmacy, the refilling of tiEN vials would not be considered ethical.
DOCUMENT 7 Ma rch 21,1930, state:nent of. Patricia C. Vacca, Senior Licensing Reviewer, Medical and Academic Section, Material Licensing Branch, Division of Fuel Cycle and flaterial Safety, Office of Nuclear Material Safety and Safeguards, NRC.
Ms. Vacca states that she is responsible for the review of applications for new licenses, amendments, and renewals to licenses, and is authorized to act for the NRC in granting licenses.
In her official capacity she
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has often reviewed NPI Milwaukee's HRC !!aterials License which was
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issued to HPI under the effective date of liay 25, 1977.
Its issuance was based, in part, on commitments made to the HRC by HPI, Milwaukee, in an April 29, 1977 lette'r which stated what its " Procedure' for Routine Use of Xenon-133" would be. These commitments preclude the recycling of vials for single dose quantities of Xenon-133.
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March 21,1980, statement of R. Joseph Del Medico, l.icensing Specialist, Medical and Academic Section, Material Licensing Branch, Division of Fuel Cycle and Material Safety, Office of Nuclear Materials Safety and Safeguards, NRC.
Del Medico states that'on occasion he has reviewed NPI, Milwaukee's license file in connection with his official responsibilities.
He said that in support of its efforts to obta.in licensure of its Milwaukee, Wisconsin, phannacy for the handling of Xenon-133, NPI made commitinents for the. packaging and dispensing of single dose quantities of Xenon-133.
He said NPI indicated that the vials it used for single dose quantities of Xenon-133 would not be recollected and reused for dispensing purposes.
To pennit such recycling would require some operation that would neutralize" and free the vial from pyrogens, as well as provide a new leak proof rubber or latex seal.
If such an operation were to be conducted, it should have be'en addressed and further explained by tipi during th'e application process.
DOCUMENT 9
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April 8,1980, sta tement ofa Ph.D. (Bionucleonics),
j Registered Phannacist, Radiophannaceutical Consultant.
l states that from through-
, he was employed by NPI as Regional Director of the Midwest Region (Illinois and Wisconsin). Although he had the title of Regional Director, he really performed as the manager of NPI's Chicago facility and John H. Reivas managed NPI's Milwaukee operation.
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NPI.'s central office' applied continuous pressure to cut costs and increase
{ do profits. Toward this end, NPI's President proposed that{. -_
something which,{
,3 considered illegal and unethical.
It involved
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deceiving NPI's hospital cuv.omers regarding the source of a particular drug. f refus ed.
Part of the money-making pressure applied by NPI's central office involved the breaking down of Union Carbide Xenon-
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133 into dosage units for sale to hospitals for human use.
Between approximately October 1978 and January 1979, NPI Chicago handled six or seven shipments of Union Carbide.
It was sold as is (not broken down)
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to a single hospital.
did not view NPI Chicago's NRC Nuclear o
, Materials 1.icense until about a week after a January 1979 NRC inspection.
b' hen he read Condition 15 of that license, it was absolutely clear to him that NPI was in violation of that Con'dition by buying Xenon-133 from a source v.hich did not have an ' approved NDA and selling it for human use.
He feels that NPI officials, who had copies of the license, should have realized this, f ' ~
has no idea why, from the beginning of his
.t employment, he did not have a copy of NPI Chicago's license.
From the beginning h5 requested one from NPI's President, who only had to send it to him.
L' hen he took over management of HPI Chicago,':
found things to be chaotic and he did not have a copy of his 1.icense.
He found many radiological safety tests were not being perfonned that, it subsequently developed, were NRC license requirements.
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Note: From the above and from information which will be summarized
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ladacopyof elsewhere in this package, it seems clear that iff -
HPI Chicago's HRC license at the time he assumed his official duties, there are things 'he would not have done which, in turn, would have resulted in decreased profits for NPI.
~
- When.
.provided his April 8 statement, he did not recall the NPI Chicago license condition number which required that NPI purchase Xenon-133 fra a source having an NDA.
He was shown NPI Milwaukee's NRC Nuclear Materials License and recognized the language in license Condition 15 as being typical of the language in NPI Chicago's license. Therefore, in his stattnent of April 8 he makes. reference to " Condition 15."
The language he was referring to, which is contained in NPI Milwaukee's license Condition 15, is actually contained in license Condition 16 of NPI Chicago's license.
DDCUMENT 10 March 10,1980, l'emorandum for Lawrence J. Strickler, from Ronald M. Smith. -- -
I This memorandum researches the issue of whether willful violation of 10 CFR 19.11 (failure of NPI Chicago to have on hand and posted a copy of their NRC license) can lead to legal sanctions.
The writer concludes that willful failure to post its NRC license (and by inference to have i
it on hand) could be criminally prosecuted under Section 223 of the Atanic Energy Act (42 USC 2273)..
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2-1, 1980, interviews of i
DOCUMEhT 11 '
h 3, 4, and 17 and reviewed in f
Report of february 13,14, and March 11,... _
final on March 25, 1980.
d red through NPI Headquarters
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said that NPI Chicago generally or eto NPI Chicag l
and the goods were shipped direct y ide Xenon-133 which, as well as.
One exception involved bulk Union Carbdose), came He une I edi-Physics Xenon-133 (unit bulk Xenon-133 into syringe doses, a
.said that NPI Milwaukee broke downHe admitte PI Chicago He said that well as into vials.
but never NEN's.
e ran out of 2 ml. vials and reused som, e units is very profitable breaking down tiulk Xenon-133 into dosagling the p opposed to buying and then sel rough i
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DOCUMENT 12 12, 1980, interv ew ol on March 21, 1980.
Report of Februarydrafted on March 6 and reviewed in fin I Chicago from!
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f a radiophannacist, worked for NP f~.._ _
In April 1979, Regional Director.
I d he maintained that t.
throughi.._.
the Manager of the Chicago Office PI and i
~
madeF t eight t
until his resignation.
tion of NPI Chic ~ago by NRC, abou
~
title prior to the January 1979 inspec 133 were received which went, as bulk shipments of Union Carbide Xenon-d up
.said NPI Chicago picke i tal.
received, directly to one hosp This included waste Xeno radioactive waste from its custoners.About 80-9 d of.
single dosage unit vials.
I Chicago because there were no n The remainder were refilled by NP I
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vials and does 'not believe his fellow radiophamac s I
the staff and it was l
said that refilling was infomall[ discussed among fill NEN vials because the concensus that "it wuld be unethical" to re k'heni ebecame Office they.had pemanent NEN labeling on them.
It became clear to him that t
Manager he read NPI Chicago's NRC license.NDA, dispensing it for since Union Carb.ide's Xenon-133 did not have. an human use would be in violation of NPI's NRC license.
DOCUMENT 13_
by Lawrence J. Strickler.
_ April g,1980, Memorandum for File d by NRC to receive, This memorandum shows that NPI Chicago was not license il November 16, 1978.
Despite acquire, possess,.or transfe_r Xenon-133 unt found NPI to have.
this, a January 31-February 2,1979, NRC inspect on -
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Carbide's) on at least procured "Not for Human Use" Xenon-133 (Union (before 12,'1978 seven occasions between October Purchasing Xenon-133 in the absence 12, 1979.'
the license) and January 30.3 of 10 CFR.
of licensed authorization is in violation of ition prohibiting Tht only was HPI in violation of a license cond from a non-NDA.
Note:
its acquisition of Xenon-133, intended for human use,not licen 16,1978, it was source, but prior to November Additional data indicates that betw acquire, etc. any Xenon-133.
i ed Medi-Physics 12, 1978,, HPI Chicago rece v June 6,1978, and October least 17 separ' ate occasions.
prepackaged single dose Xenon-133 ' units on at
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DOCUMENT 14_.
April 8,1980, letter frcxn fomer NRC employee, Bruce Dicey, to Jerry Strickler, Office of Inspector and Auditor.
2, 1979, In his letter, Dicey, who conducted the NRC's January 31 and Febru I.
hich inspection of NPI Chicago, furnished infomation from his notes w Xenon-133 before show that NPI Chicago received at least 19 shipnents of At least two of these shipments were from NPI Milwaukee November 16, 1978.
Since NPI Milwaukee was authorized only to transfer nuclear itself to such Note:
material to licensed recipients, its failure to restrict 10 CFR, transfers was violative of f 30.41(b)(5) and s30.41(d) of DOCUMEffT 15_
Radi opha macist.
March 19,1980, statsment of)
~
he was employed 5through states that from-[
NPI Milwaukee's as a radiophamacist with NPI, Milwaukee, Wisconsin.
Union Carbide manager, Jon M. Reivas, instructed him in breaking down Based on ' the cautionary Xenon-133 for packaging into individual doses.
labeling on the outer container of Union Carbide's Xenon-133,{
He expressed his became concerned about its suitability for human use.
Reivas said that the other HPI radiopharmacies were concern to Reivas.
~
said that the using Union Carbide Xenon-133, so it must be O.K.
d it Xenon-133 which HPI broke down went to hospital customers who NPI did not test it for for lung ventilations for human patients.
never carefully read Vnile employed by NPI, radionuclidic purity.
He said that upon being shown a NPI's NRC Nuclear Materials License.
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>:i-copy of it and reading Condition 15, it became clear that Union Carbide's
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Xenon-133 was not indicated for human use.
He knew from prior work
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experience that Union. Carbide did not, have an HDA.
With the exception s
of a small amount of Medi-Physics single dosage unit Xenon-133, virtually all of the Xenon-133 gas handled during'
.' time with HPI was from
[
Union Carbide. Eighty percent was broken down and the rest was sold in bulk to hospitals. Union Carbide's Xenon-133 was much cheaper than the other available source of bulk Xenon-133.
The vials used for unit dose dispensing were often reused many times.
Reivas instructed to put I
vaseline on the rubber septas or they would leak.
They were penetrated as many as 100 to 200 times each.
The vials were reused until the septum tore.
In some cases, it broke loose from the crimp seal.
Some n.
, had so many holes' that they even leaked badly with vaseline on them. The combination of vaseline and quick delivery, in; '
judgement, probably '
kept vials from leaking to a point where the validity of a lung scan was Jeopardized.{
felt it was poor practice to reuse these vials and that such' practice could result in problems of contamination., During Y
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l the period of his employment, HPI Milwaukee was often in violation of Wisconsin State Pharmacy Board requirements and Reivas gave' instructions l
f designed to mislead the Board's inspectors so they would' not learn of l.
HPI's noncompliance.
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DOCUMENT 16 #..f. ' * :
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m Report of March 14,18, and 19,1980, interview of f - [..',',.J h rough drafted on M, arch 25 and reviewed in final on April l',1980. ~
l said that NPI Milwaukee was frugal at the expense of following
. good pharmacy practices.
He said that there was a great profit in buying and reselling Union Carbide Xenon-133 as distinct from buying Xenon-133 fran the approved source of bulk Xenon-133.
Xenon-133, which was broken down for dispensing in unit doses, was distributed in syringe.s l
and vials. The quantities of Xenon-133 used, plus the amount HPI needed i
for itself, were such that on the day HPI ' received its bulk Union Carbide Xenon-133, its possession would have exceeded license requirements.
DOCUMENT'17 l
hpril 23,1975, lett'er from Robert tee Sanchez, NPI's President, to John E. Boyer, NRC.
khis letter, among other things, contains HPI's commitments to the NRC for the ordering of radioactive materials.
It shows that NPI was knowledgeable of, and sensitive to, the fact that it could have no more radioactive material on hand-that was specifically permitted by its HRC radioactive - - --
material license (see 7 b. through e. on page 2).
Note:
This letter was incorporated 'into license Condit' ion 17 and failure to abide by this commitment would be considered a license violation.
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DOCUMENT 18 1
N March 4,1980 Memorandum for File by 1.awrence J. Strickler.-
This memorandum contains a February 27, 1980, letter from fonner NRC employee Bruce Dicey who conducted the January 1979 inspection at NPI Milwaukee.
During that inspection NPI's manager, John M. Reavis, furnished Dicey with a vial which Reavis said was representative of unit dose vials containing Xenon-133 furnished by NPI Hilwaukee to its customers.
When Dicey left NRC's employ, he gave.the above referenced vial to Carl J. Paperiello, Chief, Materials Radiological Protection Section #1, NRC, Chicago, II.linois...On February 28, 1980, Papariello confirmed receipt of the vial and agreed to maintain custody of it until such time hs it might be needed.
Note:
Papariello has advised that the vial does not bear any labeling and that it does.n'ot show signs of having been recycled.
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DOCOMENT 19...-
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April 2,1980',' ' statement.o.f Patricia C. lVacca, Senior Licensing Reviewer.
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1 NRC.
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Ms. Vacca states that NPI, in letters to the NRC dated March 18, 1975, and April 29, 1977, made commitments regarding its treat;nent and preparation of all glassware, vials, rubber closures, etc. used in the preparation and storage of radiophannaceuticals and for the receipt, handling, s
packaging, etc. of Xenon-133.
These commitments, were incorporated into license Condition 17 of NPI Milwaukee's Nuclear Materials License.
It is Vacca's opinion that NPI Milwauk' e would be in violation of its e
license Condition 17 if it were to collect and recycle the vials it uses to package single do,se quantities of Xenon-133.
Vacca advises that prior to April 27, 1978, NPI Milwaukee was not licensed to pick up and dispose of radioactive wastes (to include Xenon vials) from its customers and a December 23, 1977, letter from NPI is available which clearly shows that NPI knew this.
License Condition 18, the amendment to NPI's license which pennitted NPI to initiate the pick-up of wastes from its customers, only allowed the waste to be disposed of - not to be recycled.
DOCUMENT 20 April 9,1980, statement of Rebecca H. Wood, Ph.D., Supervisory Chemist, Division of Oncology and Radiophannaceutical Drug Products, Bureau of Drugs, Food and Drug Administration.
Dr. Wood states that as part of her official duties she reviews NDA applications and IND notices and makes recommendations on their approvability or non-approvability.
She said that Xenon-133 is considered by the FDA to be a new drug and its commercial use as a radiophannaceutical requires m.4...................................:........................................................
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an NDA approval.
She said that Union Carbide manufactures Xenon-133, but does not have an approved NDA for it. She advised that Union Carbide
~
provided their Xenon-133 product specifications to FDA and that these specifications are in FDA's Drug Master File (DNF).
She explained that having a company's product specificati,ons in FDA',s DMF simply is not indicative of the products suitability for use as a radiopharmaceutical.
She said that Xenon-133 has radioactive and non-radioactive impurities.
A coupany with an NDA must guarantee their product's minimum Xenon-133 and maximum impurities.
Union Carbide is not required to make this guarantee, nor do they.
She said that without this guarantee, there can be no assurance that a person being diagnosed might not suffer various P
adverse effects, including misdiagnosis and possibly unnecessary radiation exposure.
She enphasized that Union Carbide's Xenon-133 would be considered not suitable by the FDA for use in humans as a radiophannaceutical.
For medical use, it should only be provided to recipients having either an approved NDA or an active IND for Xenon-133.
She said that.no finn j
holding an approved NDA for Xenon-133 and using a rubber septum vial, is
~
pennitted.to recycle the vials.
She said that recycling such vials could result in, among other things, excess leakage and that excess leakage could lead to an invalid diagnosis of a patient or the unnecessary exposure to radiation of the patient or others.
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DOCUMENT 21 April 9,1980, statement of Martin Nissel, M.D., Group 1.eader, Radiopharmaceutical Drug Products, Division of Oncology and Radiopharmaceutical Drug Products, Office of New Drug Evaluation, Bureau of Drugs, FDA.
Dr. Nissel states that he has revieked Dr. k'ood's April 9 statement and concurs with its content.
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e In addition to the above documents, which were obtained through the direct investigative efforts of our office (0IA), a number of other documents were gathered from elsewhere within NRC which tend to support many of the statements and reports of interview referenced above. These documents follow:
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DOCUMENT 22 3
February 19, 1930, letter frm Victor Stello', Jr., Director, fiRC's Office of inspection and Enforcement, to Robert Sanchez, tipi's President.
5 This letter advises that during a January 22, 1980, fiRC inspection of the Elfreth Alley Apotnecary, a subsidiary of liPI, items of noncompliance were noted which demonstrate that licensed activities are not conducted with concern for the health and safety of enployees.
Attached to the j
letter is a Notice of Violation and a Notice of Proposed imposition of
.s j
Civil Penalties in the amount of $4,000.
DOCUMENT 23 Ma rch 10,1980, letter to Victor Stello, Jr., Director, Office of Inspection f,
and Enforcement, fran Mary E. Mcdonald, an attorney representing NPI.
This letter challenges the validity of one of the findings referenced in the NRC's Notice of Violation, but despite the challenge, foneards a check in the amount of $4,000 in full payment of the two proposed civil penalties.
DOCUMENT 24 April 1,1980, statement of f licensed Phannacist. ^ -"~
s a
[,
states that he was employed by NPI,f
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ifrorn i
~
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through; During this L...
i 1
employment, he served as Assistant 1.aboratory Manager from December 1979 through February 14, 1980.
The remainder of the time he served as staff phannacist.
Brouning said.he was never shown a copy of NPI's NRC license orrocc}....................................................................:..........................<
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and was never made aware of its various conditions.
After working for NPI for a short period of time he observed that safety practices and procedures were often non-existent or basically inadequate. 'He learned that, despite the fact that certain required procedures were not carried out, documents were prepared to fraudulently indicate that such procedures had been followed.
DOCUMENT 25 Report of April 8 and 9,1930, interview of/
. dated April 10,1980.
~
said that until December 1979, NPI purchased bulk Xenon-133 from GE (General Electric) for breaking down and dispensing in unit doses. Fran Decenber 1979 through.the end of his~ employment with NPI,
^
Xenon-133 was purchased in prepackaged individual doses from tiEN.
knew of two instances where~ NEN vials were returned from hospitals for' disposal, but instead', were refilled because some activity remained in
~
them.
DOCUMENT 26 Memorandum of March 26,1980, from John W. Cooper, NRC Section Leader, Regional Licensing Section, to Vandy L. Miller, Chief, l'aterial Licensing Branch, NRC.
This memorandum pertains to a post licensing visit which. Cooper conducted in conjunction with an IE inspection of NPI Chicago.
In it he identifies numerous possible license violations and in item 3.a. on page 4, he ide'ntifies a phannaceutically unacceptable practice which is also addressed on page 3 of the l' arch 18 and 19,1980, interview of
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-,'in his interview, depicted the frugality of NPI Milwaukee's management by showing how liPI routinely tried to save
$.30 at the passible expense of contaminating an injectable solution.
DDCUMENT 27 Fa rch 20,1980, Memorandum to Region III files from G. A. Phillip, Region III Investigations Specialist.
This memorandum pertains to the Parch 12, 1980, interview of f.
j-claimed to have been employed frome
~
to; j
by NPIl According to the memorandum,',
served as a laboratory technician.
Although he wrked in' a high radiation area, he had never been supplied with a required film badge which measures radiation exposure.
} allegedly claimed that during the NRC inspection of NPI
during the week of February 25,1980,.he was given the film badge assigned to an NPI driver.
The reason he was provided with the driver's badge was to prevent the NRC inspectors from finding out that!
, shad not
- been provided with his own badge.
Note: The significance off..
allegation is that although he worked - -
(
in a high radiation area, NPI's failure to provide him with a radiation badge makes it impossible to.detennine to what extent he may have been exposed to radiation during the course of his NPI employment.
By providing him with the film badge of another employee in an effort to deceive the NRC inspectors during their February 1980 inspection, any radiation that was exposed to will be erroneously charged to the individual whose film badge
- was wearing.
This results in a false exposure record
.i for bat (
and the enployee >; hose badge he was 5.varing.
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We are keepin'g all' original statments on file; however, they are available if and when you should need them.
If you have any questions about this package, please contact Jerry Strickler (492-7170).
" ^ * ' ' - ~
Sincerely, e
OrigbalSigned by Ropfo:turst '
Jj Roger A. Fortuna, Assistant Director I
f for Investigations 1
Office of Inspector and Auditor
.j
Enclosures:
/
j As Stated kg.
4 pD Distribution:
OIA 79-54 DIA Reading RFortuna JStrickler l
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