ML20023C880
| ML20023C880 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/1980 |
| From: | William Ward NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180196 | |
| Download: ML20023C880 (7) | |
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MAR b i 1950 MEMORANDUM FOR:
The file FROM:
William J. Ward, X005
SUBJECT:
NUCLEAR PHARMACY INC., PHILADELPHIA / ALLEGATION CONCERNING On March 21, 1980,. I returned a call to an individual in Philadelphia, Pa. who had earlier called Loren Bush, DSI regarding the subject allegations.
During the course of my conversation with him, he provided the following information in substance:
Until recentiv. had been..erap_loyed_bv.NPI as an-
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resusteo in civil enforcement action against NPI by Nxt in October 1979.
As a result of the publicity surrounding that incidenti however, in a meeting with the NPI Radiation Safety Officer and other NPI o_fficials,
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iff did not eTaborate as to wiist yas to be quiet aoout).
He clailed that as a registered pharmacist he had to, as a matter of con-science, bring to NRC's attention certain unsaf e practices.
He then stated that NPI was above all interested in increasing profits even if it meant that safety were compromised.
His primary concern related to the sterility of certain radiopharmaceuticals, particularly Technetium.
He indicated that his particular concern related to the manner in which dose units were extracted from the generators and packaged.
He claimed that there was little if any quality control regarding their asceptic conditions or pyrogenicity.
He expressed concern that he and other technicians had to disassemble technetium generators to recycle saline and lead.
When I explained to him that he would be contacted by Region I, he stated that he preferred not to deal with the regior..
He claimed that he felt that regional personnel were too close to NPI in that they assisted NP,1 in complying with NRC requirements.
I specifically asked if he were alleging employee misconduct; he said no, and that his concern was quite subjective.
He admitted that it was quite possible that the Regional employees were operating well within the scope of their duties.
Nonetheless, he stated that he wanted not to deal with Region I anysay.
I told him that it would be possible to task IE:HQ to contact him and that I would be back in touch.
I furnished him my telephone number and told him to feel free to call collect.
The foregoing was then furnished to Jim Sniezek, Director, ffMSI.
Af ter first advising George Smith, Region I that IE:HQ might be responding to an allegation regarding NPI in Region I, Sniezek agreed that an interview was 9 propriate and instructed me to arrange for one to be conducted by an IE: HQ investigator
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I recontacted the individual and informed him of'the foregoing.
He has agreed to advise me as soon as possible as to a date for this interview.
He did
. express concern, however, that he be ' granted confidentiallity.
I then exp1_ained 4
the NRC policy in this area to him.
We ended the, conversation with his stating I
that he wished to discuss this matter wit.h;,
f il dillia. J. Vard Senior Investigator, IE cc:
V. Stello, IE D. Thompson, X005 J. Sniezek,-FFMSI L) liurray, 01A R. Fortuna, 01 A 9
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STATEP.ENT OT t
PHILADELPHIA, PEliN5YLVANI A APRIL 1, 1980 I,
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hereby make the following statement to Mr. Peter E. Baci,
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who has identified hiaself to me as an Investigator with the U. S. Nuclear Regulatory Cor:aission.
I make this st$tement freely with no threats or pro-mises of restard having been made to me.
I live at-
, Philadelphia, Pennsylvania 19147, and am a 1978
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graduate of the Teaple University School of Pharmacy with a B.5. Degree in Pharcacy.
I did undergraduate research in the area of radio-chemistry and took various elective courses in the theory of radiation safety and practice.
I am a licensed pharmacist in the states of Pennsylvania and New Jersey.
I started work with the Nuclear Pharmacy, Inc. (NPI) on.
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~ ~ hen I was promoted to was employed as a staff pharmacist untild-w until I submitted I served asa,
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i my resignation on and'hence served as a staff pharmacist once again until I lef t the employ of NPI orf Af ter working for NPI for a short period of time, I observed certain practices which I considered to be poor pharrr.acy procedurej,.I also observed a lack of saf ety practices and procedures and these which did exist were basically inadequate.
h'ith respect to NPI's safety prectices, I attributed an'y problems in this regard to the fact that twas a relatively new operation (having opened the; several weeks prior.to my beginning e. ploy::.ent) and the fact that they did not
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8 have a radiation safety of ficer.
During the entire time I was employed by liPI, I was never shown the liRC license nor the applicable rules, regulations, or procedures undcr the license.
In February 1980, I specifically requested that the radiation safety officer,j y.
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L show me the license but was told by Mr.l '
fthattherewasnoneedforme to see it since I was "on my way out."
During my employment I 'never received any formal or informal orientation or. training with respect to fiPI's fiRC license, safety practices, procedures, etc.
Except after the January 1980
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inspection I was shown how to do a check in, Procedure of, Products.
It was not until after the intervention of liRC that liPI management took any steps or established any procedures relative to instructing or indoctrinating employees in the safe handling of radiopharmaceuticals.
For example, it was not until af ter the January 1980 inspection that management took any steps towards educating personnel in procedures for checking in materials, such as external monitoring of packages, the various ways of swiping containers for surface contamination and DOT labelling.
This also was true with respect to the mandatory use of syringe shields for all dose dispensing and kit preparation.
Prior.to January 1980, no swiping of incoming shipments of radiopharmaceuticals was performed although the radionuclide log book reflected that such testing had been performed.
This was known-to management, including Steven Dessel and
!!unzio DeSantis.
Since ilPI was constantly adding new customers and the lab personnel remained the same in numbers, there was pressure to "get the job done[" consequently the practice of fnot swiping incoming shipments continued even af ter llRC's inspection in January 1980.
The shortage of personnel also resulted in mistakes being made relative to the prescriptions, including the
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mislabeling of radiopharmaceuticals.
I can recall three instances in which mislabeled doses were administered "o patients at Montgomery Hospital' the Medical College of Pennsylvania and Metropolitan Hospital.
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Another ' concern 'I had dealt with the lack of decontamination procedures and facilities.
Showers, sinks with closed water systems for disposing of contaminated water, goggles and other safety related items were not provided.
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Outgoing containers (ammo boxes) shipped to hospitals were not monitored or swiped in the majority of cases.
The only exception would be if they con-tained an. iodine or gallium product.
On several occasions, hospitals reported receiving contaminated boxes f rom tipi.
This included Germantown Hospital, Teeple_ University Hospital, Einstein.11 orth and Albington'l'emorial; the -latter drcpped its account with tipi and cited receiving contaminated boxes as one of the reasons.
While I was employed by i4PI @
4, Xenon-133 was; purchased from GE until about Dece..ber 1979.
After that time it was purchased from 1; Elf (llew England liuclear) and Diagnostic Isotopes (01) in individual patient doses.
told me the reason we switched from GE to' t? Eft and DI was because e
there was_ less change of overexposure and possible bad publicity.
It should be noted that !!PI had received a. $2000 civil penalty for an overexposure I
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had received in the last quarter of 1979 and which !?RC attributed to my dispensing Xenon-133 from the GE ampule.
While I worked at liPI, I was aware of several. instances in which drivers brought doses or vials back to llPI from l
l the hospital to be reused.
I believe this was because a partiai dose remained L
in the vial.
1 Other concerns which I had while employed by !!PI included the fact that the l
pharmacist on the afternoon shift,{
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training in working with radic, pharmaceuticals.
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_jwas frequently i
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t the only pharmacist on duty at the pharmacy in the af ternoon. " Memos posted at the lab called for the monitoring of delivery vehicles; to the best of my knowledge this was never done.
As I indicated earlier, I have never seen NPI's NRC license..I believe that I was not included on the license until with
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January 1980 because at that time I was asked to supply Mr.
background information for an addendum to the license.
u NPI made a practice of breaking down techn,itium generators for the purposes-of extracting lead for resale.
This was frequently done by myself and a technician, and towards the end of my employment, by NPI drivers.
k' hen the drivers performed this task, they 5:ere merely shown how to break the machine down and not how to provide themselves with adequate shielding or safely handle the molybdinum columns.
I felt that this unnecessarily exposed personnel to radiation because not all of the-generators were,nof. at a safe level.
This procedure was performed to salvage the lead in the generators.
Area surveys of the. laboratory were supposed to be conducted daily.
For.a three week period in December'1979, no readings were taken so the level of contamination could not have been known.
Managerr
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' told me that ' hese surveys hadn't been taken and they Manager!
t were concerned that this might come up during a future NRC inspection.
I was told to ensure that future surveys were taken and De5 antis told me that the survey sheets had to be filled out for the period in December 1979.
I'related this to lab technicians
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saw fully completed sheets in the survey logbook for the entire month of Dececher. Since I knew that the surveys had not been performed, I knew that the records had to have been falsified.
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As a cember of the pharmacy profession 1 felt 1. had a moral ob[,igation and duty to feport these concerns to the NRC.
It was my belief that tipi's concern with increasing its profiff in{ -:{
took precedence over its concern for the health and' safety of its employees and the general publie.
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I have read the foregoing statement consisting of 7 hand,<ritten pages.
It was written, at my request and direction, by Mr.' Baci and I have made any necessary corrections and initialed them.
I have' signed my name in the margin of each page. This statement is true to the best of my knowledge and belief.
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Peter E. Baci liRC Investigator Everett L. Williamson 11RC Investigatjarrce l
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