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Auclcar Pharnacy, Inc. B-TTli: Jon Michael Reavis C,.Radiation Safety Officer wnci

024 florth 6th Street Tlilwaukee, WI 53203 M_.v ..~

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[entlemen:o ,:

. nunclosed is Amendment flo. 6 to Byproduct Material License flo. 48-17456-OlMD.

;f|m e

a. :.- l .g are issuing the rcquested amendment as expeditiously as possible in order to

.-@|mcilitate your r:ove to a new location; however, you should be aware that your -7-9i5 cense i.1ay be subject to subsequent action that fiRC or the Department of Justice MDy take arising from the examination of your past activities involving distribu-hM

! aBon of xenon-133. F

. . . _ - - ,

r my telephone conversation with Mr.j ion April 28,1980, thish"endment names Mr. Reavis as radiation' safety officer and deletes Mr. Jaresko,Pom the listing of authorized users. Qb;

- $2.t-5.Sincerely, gy.K-

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. !'aterial Licensing Branch 3f'$Division of Fuel Cycle and @;;AMaterial Safet,y . m{-3,U.-

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'EnTtlosure: License Amendaent; y;f,.Q.x -rI:hl DA+pI: Mr. Jerr'y Strickler .

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STATEMENTOFI * '

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,', hereby make the following statement to Peter E. Baci,- . _ ...___ , ,

who has identified himself to .me as an Investigator with the U.S. Nuclear

Regulatory Commission. I make this statement freely with no threats or promises

of reward having been made to me.

i.

i

I live ata ~~, C'olchester, Connecticut and am currently employed as '

a health phy' sics technician at the Haddam Neck Nuclear Plant by Nuclear Support.

Services of Woodbridge Virginia. I am a high school graduate and have attended -

about 11/2 years of college at McMurry College in Texas. I served in the i(inM k.

U.S. Navy from 8/71 until 7/79 and most of that service was in the Navy's j$$5-

Q"$E-Nnuclear power program. lIn addition to various training courses I attended, -I 'j"

served aboard the USS Nathaniel Green where I was responsible for the chemical _

and radiation control of the reactor and also served as an instructor at a.

fccility in New York where I taught radiation controls and safety. I have.

extensive training and experience in the area of radiation safety, both from

my Navy service and through civilian employment in the nuclear. power industry|

prior to joining Nuclear Pharmacy Incorporated as Corporate Radiation Safety .,|

. :..

!Officer in January 1980. , .,

-.

In January 1980, as a result of a newspaper advertisement, I went to NPI :.

(Elfreth Alley Apothecary) and was interviewed for the position of Corporate

Pharmacy Manager, and Nunzio DeSantis, Northeast District [RSO by[~'~~~'

,

!. . . _ _ _, ,_ _ _ .

Manager, NPI. I was told that I would be working in the Philadelphia facility, i

:

if hired, because it was the " hot spot" with the NRC and they were very much !

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having problems at that time. They wanted me to set up a model program there'

* - _ an'd then take it on the road to other facilities. I was asked to come in and

observe their operations and be observed by them, which I did the following,

day. My next official contact was on the morning 6f the management meeting

held with NRC at King of Prussia, Pennsylvania (January 18, 1980, I believe)

at which time I was interviewed by NPI President Robert Sanchez and hired

retroactively to the previous week.' hbout an hour later, I attended the

meeting with NRC and was introduced as the new Corporate RSO. On this day I

first became aware of a possible civil penalty being levied against NPI for,

ithe overexposure of pharmacistt Rand for training deficiencies at-I -

the facility.4

At the time NPI was officially notified of the civil' penalty, .I was called at --

~

home by- .. : told me that he had been contacted by Nunzio - -

. . . t

i

~~

DeSantis and that DeSantis said that l..._ - was to have his dosimetry pulled,be immediately fired and have his keys collected the' following day. I told

'

T- tha.t from a management. standpoint this was the worst thing theyc .:. - - - -

'

could possibly do. I called Mr. DeSantis and told him that I felt this was a

very foolish thing to do, especially when I learned from him that Mr. ],,

- had submitted his resignation anyway. It was appar"ent \o ine that the matter''

of the overexposure was bein~g' blamed on Mrv and he was being fired- ~

s

for that reason. ~ Mr. {pwas subsequently allowed to resign. .

.

Shortly after I started working for HPI it became apparent to me that they had

numerous probleas concerning radiation safety, training and generally, viola-

tions of various conditions of their NRC license. I expressed my concerns.

9

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.- . .. -3- . ' .|*

regarding this situation to NPI management on numerous occasions, particularly *

:

to Mr. DeSantis and Mr. @5.Q These problems, which are far-ranging and-

extensive, have been documented by me and given to Investigator Baci in the *

form of a memorandum, dated 3/17/80 consisting of 12 typewritten and 25 hand-

-written pages.

An example of what I am talking about'is the case of an individual employed by

NPI in a dose-drawing capacity in late 1979. This individual was employed

part-time by ifPI while employed full time as a radiation worker at Temple.

University in Philadelphia. During the portion of the time that the individual

worked as a radiation worker, handling isotopes at NPI, in the same function

as Hr. [ when he received his overexposure, this individual was not in- -

fact monitored. She was -monitored during.only a portion of her part.-time

e$ployment. This can-be backed up by the fact that the dosimetry records do.

not exist, either with NPI or the contractor. This individual, who was a

female, was working at two different licensed activities as a radiation worker

and was only being monitored by one facility, Temple University. .The license

conditions and 10 CFR 20 require that the licensee monitor the exposure of a,

worker in her capacity. They in fact did not and records concerning her are .

non-existant. .flo attempt was made to correlate her- tota 1 exposure between thei .

This individual's first name was Eileentwo institutions where she worked.

but I cannot recall her last name.|

.

The requirements of the NRC Reg guide 8.20 for the isotopes and quantities

handled at NPI require that the employee have bioassay performed within two

weeks prior to handiing the isotopes, within 3 days af ter their initial expo-'

.

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sure to the isotope in the laboratory and every 2 weeks during the first 3_

~

months of their work with the isotopes, anytime a problem is suspected and-

within 2 weeks of termination of employment. This took place for no employee..

A commitment had been made to NRC by NPI to' meet the requirements of Reg guide.

8.20. These tests were performed, but very sporadically, haphazardly and in

-an incomplete manner at the incorrect intervals and without doing competent

monitoring. What actually happene'd w3s that the Assistant Radiation Officer

from Temple University visited the pharmacy, approximately once a-month, and'

performed a measurement of the thyroid of whatever employees happened to walk.

by during the time he was there. If an employee with a potential . exposure was

in the laboratory, and available, he was monitored; if he happened to;be sick

that day, they would catch him next month. I don't recall the name of the

person doing the tests but- this would be available in the records of NPI. ./ *

E''en for the . tests he did perform, tbe methods he used were unsatisfactoryv,

because the only record of the results was recorded in units of counts per

minute above background on the individuals thyroid. The NRC's reg guide 8.20I

has. all its action levels and standards listed in micro curie quantities and

there was no conversion done from cpm of the person's thyroid into micro curie

quantities so neither the person doing the monitoring or anyone at NPI had any ..

.

way of,looking at the records of the people monitored and determining whether

they exceeded the Federal standard. I later made an attempt to correlate the,

two but I could not make an absolute conversion because certain information,

was not-recorded, such as the- calibr.ation .date ' of the , source he used to

calibrate his equipment. This is very much a violation of their license

conditions and of the commitment they made..

6

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A statement made to me by C ;R .y I in the presence of Nunzio Dc5 antis,u._ ~--

,_

, _ ,

contained the following account. During the month of December, Mr.{, ;-~_-t -

~ said he did not wear his extremity monitoring equipment in the laboratory

while handling isotopes yet the contractor dosimetry report shows an exposure~

of several -Rem for that time period.

...

With respect to training, prior to my arrival, it consisted of employees being

given a single booklet summarized' by out of Temple University's radiation'. .

safety manual. No one sat down with employees and trained or explained anything ,

to them. After they were cited for training deficiencies by NRC, the company -

made sure every employee signed a statement, which went into their file,s

saying that they knew of and had received a copy of the manual and had read- - <- . . . .

,,

it. This was, in my. opinion, an attempt to cover themselves. Training was,

however, almost non-existent. The license was not posted, nor was any statement'

as to the location of the ilicense posted and no individual was trained in the

requirements of the license. Employees had no ide'a of'the dangers or concerns.

associated with working with radiation and contrary to 10 CFR 19, received no

training with respect to the hazards of such work. They had little or no idea,

|. .

of the biological effects from radiation exposure. .,

The cleaning service came in several times a week, after hours, when no other

personnel were in the building. They had keys to all areas of the lab and did

in fact go to all areas. They were not trained and were' not badged. They had

i no dosimetry conitoring equipment at all. They had access to every area ini -

! i the facility. As a matter of. fact, no one ever made an attempt to determine

if one girl in the cleaning crew was a minor or not. I brought this up and as

*- - .. - -. - --

.

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, , -6- ' . ...

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it, turned out, through sheer luck, she was 18. Apparently no one even knew of.'

the prohibition against exposing a minor to occupational radiation without.

monitoring. .

' Although they had a copy of the reg guide or bulletin, they did not fulfil the,,

requirement that female employees be trained in the huards of pre natal

exposure, that they bt given a copy of Appendix A .and . trained in its ~ contents,

This was never doneL and certify by signature ~that they receive this training.

fori who:I' mentioned earlier, for any female clerical workers or for ,

the girl on the cleaning crew. After I arrived there, employees were in fact.m

trained antf certified although the janitorial service, to my knowledge never

received any' training and I doubt seriously if they are wearing dosimatry now.

In ge'neral, the be'st way to describe the st/,tus of training at tipi is in a-

.- ,

_,

a licensed pharmacist employed in a',,

comment nade bymMr.; , _

dose-drawing capacity. Mr.~

] had been employed for at least two

months when I surveyed the supposedly uncontaminated T-handle of a dose cali-

bratof and found 35 mr/hr from loose surface c'ontamination.k' hen I mentioned

this to him, he asked: "Is that good or bad?"i k' hen you consider the levels

of contamination allowable are in units of disintegration per minute per 100 .

'

.-, '

centimeters squared, and I was surveying a clean surface *with a dose rate.

instrument, that was many, many thousands of times above the acceptable level.,

- At the same time, I .found removable contamination of 2 mr/hr on the phones, on

the secretary's typewriter and on supposedly clnan areas of the laboratory.,

.

Although liPI was committed to taking both radiation and contamination surveys,

only the' former was actually done. As a result,'they had no idea of the.

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levels of loose surf ace contamination which were quite susceptible to be~

- ingested by employees.- As mentioned earlier, they were not' performing any bio-

. assay to determine if the employees were in' fact ingesting this radioactive.

material.

NPI had no. dosimetry equipment for immediate issue. Consequently, new employees

frequently went without dosimetry until their names could be added to the

- vendors list and new badges, etc, sent out. The vendor sent the new dosimetry

out on a rranthly basis and employees hired in the interim simply had no badges.

or were given those of employees who had left but whose name was still on the

vendor's master list. Thus .it was difficult if not impossible to determine

total exposure since dates of employment were not recorded locally and the~

comp 0ter printout from the vendor did not necessarily reflect the actual

individual who used a particular badge.

e

Their license specified a possession limit of 15 curies on molybdinum technetium -

generators. Before I left, the last few weeks, they had gone to a more efficiente

system, a cheaper system if you will, of ' obtaining their tech 99 product.

This involved the use of the maximum sized generators offered by Union Carbide._

,,

I believe they were nominal 10 curie generators and carae in at 12 or 13 curies

of molybdinum at the time they ,were delivered but they would be calibrated to

have 10 curies of activity in them at noon the following day. Based on the

normal scheduled rotation of these generators, they exceeded and were aware

that they_ exceeded the license quantity 5 out of 7 days of the week. I made

them aware of this and the only consideration was -- well, how likely is it,

that this will come to the attention of the l'RC? The cotiipany's response to my.

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concern was:|that. I'should submit a license amendment to raise our possession?

|liinit but meanwhile ' keep using it. NPI would possess between 15 and 25 curies- ~

anywhere from 5 to 6 days a week on :a routine scheduled, standing order basis. .

- One to ~ two daysu a week the generator decays would be such-that' they would be

just u'nder -15 ' curies. They would ordinarily be arsywhere from minutely over to;. :-

10 curies over their -limit. I personally made Nunzio DeSantis and.f

directly aware of this. Their response was to ask my opinion as to.how

likely they were . to get caught with'it. .When :I said not ' very likely, .they'

said, " fine, we' re going to keep doing it. Get us a. license amendment as.

quickly'as_ you can to bring us into specification." ' Bothi " 'and DeSantis-L,

_ _ .

said this to me. When'I madei~

.)awareofit,heaskedme. When he said.

J

let' it go and I pushed it =with DeSantis, he asked me the. same thing. To me,

that was willful negligence. The reason for the excess was that it s cheaper.-

15 buy the' large generators to meet their needs then to buy smaller generators

and stagger them to stay under their 15 curie limit. It was simply economics.~

Thestatementwasmadek.omeby awhen we had ~a long and very .

serious discussion about the concerns I had there was that for five years .

radiation safety has been at the back of the bus. We' re attempting now t'o - ('

bring radiation up to 'the seat behind the driver but radiation safety will .>

-never be the dominant factor in our operation. The implication was the bottom-

line is going to drive the bus and that is profit. HPI was willing to spend

' money on'anything I suggested as long as I could relate it to a fear of the

NRC. If I could relate it to a bottom line penalty or problem, they would

spend anything I would csk for. But if I identified something and said no,

you're not going to get. cited in an inspection, that received no attention.

.

.

g. L..

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. , . - ., :-9- ..

. -

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NPI wanted iadiation safety to be present when the NRC came in and visited and -'

then put it on the; shelf again until they got wind there was another inspection

coming up.

' Going back to the area of training, a'fter I made them aware of the training

requirements and actually started training people at the pharmacy, Mr.f.

continued to employ drivers and assigned them to work with the isotopes before

..' they were trained or issued dosimetry. After I made them aware of the fact

that it was a violation, they continued to have this cleaning service come in,

without having received training or dosimetry equipment. I should state at this

,

point that almost every problem 'or possible violation I identified was made-

, _ _ _ - -

known by me to Mr.' DeSantis or Mr.f . ' or both.

-

,_

"

I brought the matter of dosimetry to- the attention of' management but it had '

apparently already been brought to their attention since in their initial

license application, they said that they would badge drivers after they had'

. been there 30 days or 90 days, I'm not s' ce which. However NRC came back and

said that badges must be issued before anybody could work in the areas in or

around which the isotopes were located. They changed the commitment in their- .,

license application after that, but not the actual practice. 1

.

In sucmary, I wish to say that as I enumerated in my March 17, 1980 memo to

H r.|, .-_.

. . the problems and possible violations at NPI (Elfreth Alley). . , _ . . . .

are numerous. The basic issue is that NPI is, in my opinion, committed to a

radiation safety program which will, by the minimum effort and cost, keep the

NRC out of their hair. They will do what they have to do to pass an inspection,

.

(,, .-

: ~..'. e :.

. -30- ',,

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'but.if it'looks as if'an item would not crop up they will not address it,~

sa ety item or not. This was readily apparent to me der.ing my employment with-

them and is the reason I submitted my . resignation and lef t the employ of NPI,,

on-March 17, 1980. . I have read the foregoing statement consisting of 12

handwritten pages. It was written at my request 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.

_ _//s// '

l' .

.

Subscribed and sworn to before me this 36th day of May,1980 at Colchester,Conn.

.-

. //s//.. Peter E. Baci -

NRC Investigator

-

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STATEMENT OFi_ _. .__.._..-s- ..,

,

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f- '.hereby make the following statement to Peter E. Baci who has

' identified himself' to me as an NRC Investigator. _I make-this statement freely

with no threats or promises er reward having been made to me.

1.

I reside at Colchester, Connecticut. I am currently employed.

ias a health physics technician at- the Haddam Neck Nuclear Plant by Nuclear i

Support' Services of Woodbridge, VA. I have about 1 years experience working.

in the nuclear industry, including service at various power plants. This

service was primarily in the capacity of a health physics technician and

included service at Three Mile Island after the accident as a member of the

TMI-Unit 2 recovery team. In February of 1980, I went to work for Nuclear gur:n.-

PEarmacy, Inc. , initially at Philadelphia, and stayed with them for approxi- jf{.V ~,.mately 30 days at which time I submitted my resignation.

.

The irtintion.of.NPI when I was hir'ed was for me to work in the Chicago -~

~

facility and implement radiation safety procedures which Mr.l_ _ _ . !

the i

-

'

Corporate RSO, was setting up in Philadelphia. I was eventually going to ,!,

ris handle the labs in all the NRC states, so before I 'left NPI I briefly visited

,

the. facility in Milwaukee and spent about a week in Chicago in addition to -,

approximately 3 weeks in Philadelphia. The reason I left, along with 'I

fir.~~

I was that we felt that we would be ineffectual in trying to

establish a radiation safety program, given the corporate attitude towards

this issue, and further that a joint letter of resignation would carry more

significance.' -

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I r.ecall one instance when 1 was out at the Chicago facility and was in the ''

office doing paperwork. Nunzio DeSantis,- The District Manager was there and.

received a call from Mr. ~ in Philadelphia. After their conversation, .

_

Mr. DeSantis told me that Mr.{ ~ :.was concerned about violating the

possession limits for molybdenum in connection with the technetium generators,

since they had started to use larger generators. My comment to him was

essentially that, "well, you have to do what the license says or you're liable

to get cited for it." His reply was that we were only in violation a few days

out of the week and we always come back within the limit. My impression after.

this conversation was that he would be willing to chance being in possession

of excessive amounts of molybdenum in order to be able to use the larger,

more efficient ge,nerators.- .

-

.

'~

Another example of the safety conditions and the level of training and awareness'

of the NPI employees can be seen in the comment to me by who was theL- - . .:n --

pharmacy manager in Chicago. twould usually not wear a ring ' badge, wrist....-.m

dosimetry or lead lined gloves whil'e drawing doses in the lab. When I asked

him about this, his reply was, in his words, "well, I still don't believe that

stuff will hurt you." I told Mr.| ~ .that he was required to wear dosimetry ',i- .

.'

'

and pointed the problem out to Mr. DeSantis while he was there. In a

conversation which occurred later in a coffee shop, Mr. DeSantis, myself and,

anotherradiopharmacist,f (LNU) were present, when they were talking about,

limits and I mentioned the overexposures in Chicago. Nunzio's comment to me

was that "overexposures are easy to dontrol, you just don't wear dosimetry." I

had pointed out to him the requirement to use syringe shields, lead-lined

- - - - - - _ _________ _ - - - ..

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2.-

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. gloves, etc. , and even showed- him their own memorandum on this matter.

Syringe shields were used, but more on an "if you felt like it basis."

.

Another of the problems I observed had to do with the rapid turnover in

delivery drivers at the Chicago facility. These drivers had no training

whatsoever and frer,uently wore no film badges. Film badges were always a

problem and while I was there we went from a monthly to a weekly changeout of

badges. OnedaywhenIwasinChicago,f the girl who was assisting with

dosimetry, had forgotten to change the dosimetry for everybody. So there were.

some people with new badges and some had badges which had to be sent in. Some\ .-

people couldn't even find their badeges. Ipointedthisouttoj _ _ _

that there were some people who couldn't draw doses because they didn't have

dosimetry. He more or less shrugged it off and said that would be in

shortly and she'11 get them changed and then we'11 be OK. 'But thereiwas still,

a 2b hour period before she got there when these people were handling activity.

'

During the relat.ively short time I was employed by NPI, I observed a great

many conditions which I understood or knew to be violations of their NRC'

license conditions. I brought these conditions, which I saw both in -

Philadelphia and Chicago, to the attention of NPI management on many occasions,'

Iprimarily to District Manager DeSantis, Chicago Manager and Philadelphia. . . . - _y__

Manager | IassistedMr.{ ,in the preparation of a memorandum-

,

dated 3/17/80, which enumerated in great detail the various problems and

possible license violations which existed in Philadelphia. Having spent a

week in the Chicago facility, I can safely say that 75% of the items in the

*

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-_

me,mo of 3/17/80 represent conditions which exist in Chicago as well. This- ,

.-.

is essentially true with respect to dosimetry 'and training..

The cleaning forces _-in both| Philadelphia and' Chicago had access to all parts

of the lab and wore no badges and were given' no training regarding the possible-

hazards of what they might encounter.,. In Philadelphia they came in when no

one was there, after hours, but in Ch'icago they came in when someone was

. there. There were times when I found contamination levels on.the floor which

I attempted to clean up myself. In one instance I taped absorbant paper on a.

spot, to cover it up until I could get a better handle on it. But in those

places I didn't find there's no telling what this man who came in to clean

picked up or spread around using his mop. - -

'

.

i

Nith respect to the su'rvey situatio'n, 'after looking at their: survey-booktin~

Philadelphia prior to Mr.f '_ _

getting there, contamination levels were

a'll listed in mr's per hour and you cannot designate low level contamination

levels 'in mr's/hr. In Chicago, the survey situation was almost the same.

They were very lax in doing them on a regular basis. They would do them for 2

or 3 weeks and then there would be a gap of about a month. Vehicle surveys,.

'

were simply not done in Chicago. -

.

From the general attitudes I encountered and from the way I saw business run,~

they appeared to want a model HP program that they would pull off the shelf

and show to the NRC when they come, but which they could stick back on the

shelf until the next time they come around..

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_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ .

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Ano,ther incident which comes to mind has to do with the transporting of waste'

material across state lines. I was going up to Milwaukee and I heard that

DeSantis wanted me to pick up waste in the lab there and transport it to (~ Chicago for disposal. Since they don't have a license to transport hot

material, the material was then described to me as " decayed" after I raised an -

objection. This would have been alright had they had any layout as to what

was decayed or not decayed.~

'

In Philadelphia, Abingdon Hospital received contaminated shipments on 6 to 8,

occasions. Abingdon kept a running log of contaminated boxes they had receive'd

from NPI, and after receiving a number of those, made the 11PI sales representa-

tive aware of it 'and gave him.a list of' the dates and the levels that were'

found. If NPI had been fulfilling its requirement to monitor and wipe outgoing

shipments, there is no way the hospital could have received a contaminated

box. ,

The philosophy of the company concerning individuals who had received over-

exposures appeared to be t'o try to get rid of them since they brought bad

publicity to the company. This was true in the case off _ _ _.in . .

,

,, , in Philadelphia. They treated- these individualsChicago and i-,

.,

like lepers even though it's hard to keep from being overexposed when employees

have no training in what they're dealing with or not working with proper

radiological safety. controls. DeSantis even remarked about P ~Iat oneL. _ __ . .

point and said that "he wouldn't go anywhere in the company because he's an,

overexposure."

,

, _ _ _ _ _ _ _ _ - _ - _ _ _ _ . _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ . _ _ . - _ _ _ _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ - - _ _ - _ . _ - _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ -

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In. summary, there were numerous instances of violations and unsafe . conditions,' '

4

both at the Chicago .and Philadelphia facilities, which were made known' to' Mr.n . , - - ,

DeSantis and to Messrs. / - .,_j8andl .. , almost on a daily basis. In most.

. cases, even when _these ~ individuals become aware of these violations, no action

was taken to change or correct the condition unless there was a likelihood of

being caught by, the NRC. .This basically reflected the corporate attitude'

towards radiation and was the primary' reason I resigned, along with Mr.; ,

,on 3/17/80.

.

.

I have read the foregoing statement consisting of 7 handwritten pages. It was

written at my request by Mr. Baci and I have made and initialed any necessary

corrections. I have signed my name in the margin of each page. This statement.. .. . .

is true to the best- of my knowledge and belief..

. ..

e //s//- _ . . .

__

_ _ _ _ _ .,,,6

Subsc:-ibed and sworn to before me this 16th day of May,1980 at Colchester,

Conn.

.

'

//s//-.

'

Peter E. Baci *

.

NRC Investigator

.

//s//

lWitness

.

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6

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,TO:._

... _ _ . _-

...

__

FROM:. ._. .- _,

- Radiation Saf ety Officer PA-; .

'

RE: Status of NPI Radiation Safety Pro 6 ram

DATE: March 17, 1980 .

-

As you are assuming reponsibility for HPI's radiation safetyprogram, I f eel that it is necessary for me to give you a fullreport on the pro 6 ram's current status. The format I am taking

is to summerize the conditions Ifound, the steps I have taken,an assessment of current conditions, and finally my recomend-ations for future action. .

BACKGROUND INFORMATIOR

I was employed by NPI on January 22, 1980, retroactive to Jan-uary 16, 1980, as I spent time in the PA-1 facility as an observerprior to being formally hired. My function, as I understoodit at the time, was to take whatever actions I deemed necessaryto establish a "model" radiation safety program at PA-1. Thisnas to be done with the overall objective of desi ning a radia-6tion safety program adaptable to all company facilities and pre-pare a program to pro 5ressively implement it throughout thecompany. y

However, ensuing events departed from this initial concept.Due to problems in the IL-1 facility, I was told to hire atechnician to work in Chica50 and train him at P3-1 for thirty

kgg <PDd5days. After he was hired, a decision was made by NPI manage-ment to have him also function as a technician for the '.71-1 > :e.e ts

Ep ,.p,,%,q (3acility. .

- .

.%,'

- - - - - . --

lef t for the Chicago f acilityThis technician, . ...

after three weeks at PA-1 due to an impending URC inspectionat IL-1. Due to the unanticipated volume of work he found tobe done at IL-1, I was ver'oally instructed by the district ,

and -

canager to hire a second technician to assist at the IL-1I!I-1 facilities. Af ter locating and interviewing a suitablec an di dat e, and determining his availibility, I again contact-ed the district maaager. At that time, I was told to put offhiring the technician for the time being. As Mark's workloadwas such that he worked 47 hours durin6 his first three days

I can only assume that the decision not to hire theat IL-1,additional technician was made for economic considerations. |

The rationale I am assuding the company used tas that since -

the additional |the NRC inspe'ction had already taken place,technician had become a luxury, not a necessity.

I

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~ ' Ddring the time thath res. at IL-1 an d '|1I- 1, we communi-'

cated once .or more cacli day to resolve troblems rith theiro .

- radiation safety progran, fL~ . | returned from Chic'ago on Feb-~.

'

ruary 5, 1980 and intended to return on February 11, 1980...

hiso during my employment, I have on several occasions beencontacted by home office. personnel: to assist them in radiationsafety policies and information for other company f acilities.I was in one instance contacted by MPI . personnel in Texas '

seeking advice on handling of a incident involving the sus-pected loss of more than one half of a curie of Xe-133All of the above have recuired that extensive amounts of mytime for the past eight weeks be devoted to areas of HPI otherthan just the PA-1 facility.

.-

INITIAL CORDITIONS

The records and documentation I was gilen initially consistedof one folder containin5 the NRC license appl'ication, license,associated correspondence, and some correspondence with thecorporate headouarters in regard to the HRC and state licenses.As time progressed, other material was _ located and assembled.- Below is a discussion of the status at that time of- some ia-portant areas of radiation safety: -

'

1) Dosimetery - The 'dosimetery ' records consist of thecomputer sunmary sheets recieved from the vendor,thumbtacked to a bullittn board. Deficiencies in-

~ cluded: - -

'

a) Do record of employee start /stop dates foroccupational exposure,

b) Ho attempt to make estimates of exposurefor periods during ten months of operation

*- vihen dosimetery results were not availible

(including in several cases externity ex-posuresl

c) Instances where individuals were employedin h dose drawing capacity and uonitored witheither no dosimetery, whole body dosimetery -

, only, or whole body and ' wrist badges with no'

finger dosimetery.d) An individual who was employed part time in

in a dose drawing capacity while employed full--time as a radiation worker at a local hospital.(During a three month period, this employeewas monitored two months with whole body dosi-

, ~~ metery only, and' was drac;ing doses withoutany dosinetery having been issued to the em-ployee when 1 stit'ed, and at no time had anyattempt been nade to determine total exposurefrom the two places of employment).

.

_______m.____ __ _ _ _ . . . _ _ _ _ _ _ . _ _ _ _ . _ _ _ _ _ _ _ _ _ _ . _ . . _ _ . _ _ _ _ . _ _ _ _ _ _ _ ..

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2) Bioassav Procran, By official statement, to the URC,. .

- HP3 commi tted tnat the PA-1 facility would have bio-assay testing done at a local hospital and would cos.

' ply with MRC Reg. Guide 8.20. -

.

..

Contrary to this commitment, I found the followin6progra=:

'

Eioassay testing had been performed at the HPI. f acil-ity by a representative of a local university / hospital.This consisted of comin6 to the facility on an approx-

,

imately nonthly basis and testing inatever enployeeswere availible at the time. This obviously did notcomply with the recuirements that the esployees be non-

- itored within fourt.een - days prior to employment, rith.in 72 hours of the first potential exposure to I-123and 1-131, bi-weekly thereafter, and within . iourteen see afafter terninating tnelr notential exuosure, t .._ _

This testing was also peracroec in an -unsatisf actorycann er. The tests were perforced by first countinga nock I-131 source in a thyroid ph'antom -(while sourcestrenS h was recorded, no calibration date or ace-tcuracy reference was included thereby caking it in-possible to perform an efficiency calculation -for thedetector system). Then a one ninute count for back-ground was ' performed follor:ed by a.one minute count

'

on eae.h lobe of the tbyroid. Gross and net -counts -r < crecorded. Due -to the type probe and -scaler used, ell-isotopes capable of_being cetected by the ecuipmentwere recorded. Ho attespt was nade to determinespecific presence of I-123 or I-131. Results wereleft in units of net counts per ninute from each lobe

~

of the thyroid, and no attenyt was cade to determinethe concentration present in pc units. That beingthe unit used for all action levels in Res. Guide 8,20.

.

3) drainin t- The training . records specifically rbcuiredby various regulations; connituents in correspondence,and license include the following:

*.

Trainins in the perford.S_pgR19.Trainin6 prescribed by 10a)

of Mo-99 breakthroughb)tests:for Tc-99m-senerators- (no record ofhaving been verformed).

c) Prenatal e sposure (Reg, Guide 8.13) . a ,,cu h.

d) All personnel having access to the restrictedarea vill be trained in radiation ' safety.(There is no record of the janitorial service .personnel ever being-trained and they have notbeen issued dosinetery even though they haveunlicited access to the facility during the tice

. . eriods when no HPI personnel are present. )e) 1.nv new driver exployo6 r;ill be riven trein-

ing prior to being allcred to ce5menegrork-~

ing, (this was not done).

~!he conditicn of the training racords uay be accurately'

i

- - _ -__- __. _ _ _ _ _

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.

descr:. bed with one T ord, non-ex stent. Some individ-. .

h. m , . .,. uals nay have recieved some undocumented; training

prior to 'being issued dosimetery .and starting work.-

I have no evidence that any such training took place.1 " radiation saf ety nanual" had been assembled by thepharmacy manager. . Shortly after my ecployment, a memo:.

* vas recieved iron the home office recuiring each en-ployee to signify by signature that they had read thenanual and understood that a copy nas availible through .

the RSO. 50 training had been perforned in the areaof license requirements. The best way to describe thestatus of training is a consent nade by a licensedpharmacist who had been employeed in a dose draningcapacity for at least tuo conths prior to the incident.

-I surveyed the supposedly uncontaminated T-bandleof a dose calibrator'. and found 33 cr/hf fron loosesurf ace contanination. '.7 hen I mentioned this, theindividual's reaction was very telling. He said,

"Is that good or bad?"

The follotting are some of, the surveys re-4) Surveys-quired at PA-1 by various documents and regulationsand their status: ,

a) Routine Laboratory Surveys - Despite the licenseconcitment to perform ripe tests on all week 3y

iand monthly surveys, I have been unable tofind any record of a routine ripe test being: -

- perforced 'during the first ten nonths of the~'

f acility operation. All surveys were'perforn~

ed riith; dose rate insturacnts end results r:ererecorded in ' units of nr/hr. . For a significanttime period, no surveys :cre -performed in theand to this datebasecent waste storage 1 area,no surveys are being performed in " clean areas"of the facility or in the storage room used tohouse depleted Tc-99m generators.

~

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b) Routine Surveys of Delivery Vehicles- Thesesurveys are required by 10CFR49 173.397and are to be perforned ater each use of an

"exc'lusive use" vehicle. They were performed '.,and recorded on a monthly basis.

., c) Xe Hood Surveys- A codSitaent was made in the-license application that a rieekly .uipe test-riould be perforced on the filter inlet and out-let ports and an efficiency calculation perforn-ed. This was never done. No determinationwas ever'nade_ of the actual amount or concen-tration -of Xe-133 released to' .the atmosphere.- -

d) Various connitments viere made as to personnelcontanination surveys which were to be perfore-ed at certain frequencies such as dose drarfingpersonnel prior to leaving the area of a dosedra;;ing station and by personnel 1 caving thethe generator rcon following generator elution.

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r -- i These surveys were being accomplished on an-

intreauent> hasis : hen' verformed 5L' all.~

- e) Ho surveys (dose rate or contamin'ation) werebeing performed on shipping containers leaving

,

the facility.,

f) Surveys for the external dose rate 'emd con--

tanination levels were either hauhazard cr non-~

existent on raste'bein6 packaged for long tern .

storage and decay, s

g) 1-123 and 'I-131 Air Sampling-- These sampl esare recuired to deternine the concentrationsof _ these isotopes discharged to the- enviornment.Prior to. December 10, 1979, no surveys v ereperforced. Fron December-10, 1979 to February13, 1980, the samples: consist of a record ofthe sample pump start - and stop date and time,MCA windon settings, one minute backgroundcount, one minute sample- filter court, and inmost cases a one minute count on a rock I-131

'

standard source. The information necessary,

to calculate concentrations of I-131 discharged(i.e. sanole flor rate) was not determined orrecorded. ~ In addition, the entire procedureis designed to determine I-131' dischar6ed withno reference to anounts or concentrations of.1-125 released. - .

>

~

In addition, in all cases, the survey caos' iacked recuire'd . cd-ditiona1' information such as- the insturnent used.

_.

5) InstiEment calibration aid checks-a) ' Dose Calibrators- The facility HRO license

application specifies the testing and frequency''

of-testing. These include:-.

..

Constancy check and reference source- -Daily:comparison.

Quarterly: Linerarity test, liner inte6rety -

check, and zero adjustment.-.

Annually: Accuracy test*

' Installation: All of the above checks plus xa Geometrical variation test.

The availible records indicate that prior to receipt,the insturnents were calibrated- by the nanufacturer, andthat while in most instances daily reference source checksvere performed, they wero incomplete, performed by an in-correct nethod, and recorded in an incorrect for=ct. Hoother testing has been perforced,

b) Survey Insturnents- The license states thatsurvey inctur:r.cnts vill be~ cal.ibrated on am

.

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', . - . I t .

.

.... .

' l' " f annual basis by either the canuf a.tturer or by'

Stan Huber Associates. Do conprehensive deter-. mination has yet been made as to the status of

survey insturrent calibration. As calibration.

documents from the various manufacturers are found. .

they have been assembled. It should be notedthat the survey insturments are probably in cal-ibration r:hether or not all the anuropriate -

'

documentation can be located. This is due tothe insturments all being received ner: Euringthe preceding year. Hortev er, I have been toldthat arrangenents have been cade with a localfacility to do, and they already have donginsta'rment calibration. ::. tney--tv La .=va = ~n+n43 ir ih:: ' c .. x v ._M% this-T witit

'

_

W+en---calu-re.tsag inctmenh. Also, wh en Irecuested a copy of that facilities' calibrationprocedure to submit to the ERC in order to sod-

- ify our license, I was told by the AssistantRadiation Safety Officer of that facility thatthey had no formal or written instE?rnent cali-bration procedures.

6) Sealed Sources-

a) Testin6 for removable contanination- This facility-

- is reouired to have all sea) ed sources tested -

'by a facility in Pennsylvania for renovablecontamination at least every six months. Theonly availible records short that three of thescaled sources viere' tested by the manufacturerand the sans three viere tested by an out-of-statc f'cility on July 3, 1979 Th ere fore,they becane overdue for retesting as of January3, 1980. There are no results of any tests be-<

ing perforced on other sealed. sources in thefacility,

b) Inventory- The facility is required to perfor.m .*

an ihventory of all sealed sources posessed .

at an interval not to exceed- six conths. Thereis no record of any such' inventory ever havingbeen performed.

7) Shinoine- At the time of my employment, there werereay discrepeacies in the compliance with transport-ction regulations and recuirements. These includedthe follouing:

a) Insufficiant information recu' ired on shippingcaners.

b) So rdpe testing on out cing shi,rping centciners.6

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c) Cardboard inserts in the shir,ning' containers' ' ' ' ~ *~~

not being Osed as required.' '.

d) Absorbent caterial not being used in the ship-pin 6 containers.

e) One shipping paper being used to cover a delivery,

run having cultipyle drop off points.,

f) Ho shipping papers requested or received forpicking up waste returned by accounts.

g) Ho security seals being employed on the ship- -

pin 6 containers.h) Ho dose rate or contarination surveys periore-

ed on:1) the waste returned froc the accounts

prior to its disposal,2) the shippin5 containers prior to their

reuse,3) and the shielded containers for iso-

topes prior to disposal or reuse ofIne containers,..

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i) Transport inder and labels Tiere being deter-cined from the curie content of the shippingcontainers and not by direct survey.

j) Shipping containers being left at various accountsin unsecure areas to uhich the General publichas access vithout requiring physical accept-ence of the shipment from personnel at the ac-counts facility,

k) As rentioned earlier under surveys, the vehiclesurveys viere being performed on a conthly basis,not after each use as required.

1) Drivers :ere erylcyed and utilized both viithinthe f acility and for deliveries trithout formaltraining in radiation safety in most instancesand in several cases riithout being issued dosi-netery.

'.

o) Contamination Control- The specific requirementsspelled out for contamination control in the facilityinclude: . .

a) routine ripe surveys rieekly and monthly,b) personnel surveys at various frequencies,c) decontamination f any surface found to be

2h100 dpa/100 cc ,d) surveys required to meet requirements of 10CER49

and 10CFR20,e) and wipe test surveys on incomin6 packages

containing radio active caterials.

The actual status vias:

a) no routine teekly or conthly r;ipe surveys,

b) infrequent or no personnel surveys,c) changing absorbent paper en labcratory v:ork

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d) and records of wipe surveys on inc;oning pack-' *

ages.

An initial random survey of supposed clean areas showed'

dose rates resulting primarily and in soce cases exclusive-.

ly from loose surface conts~ination that ranged from 0.5to 2.0 cr/hr on telephones and calculators, up to 33 nr/hron ooth dose eclibratcr T-handles. No routine surveys .

~

were being perforced by personnel leaving the restrictedSurveys were not being performed on outgoing pack-area.Yiaste was being transfered to the basement for stor-ages.

age via clean areas with no wipe surveys on externalsurfaces. Personnel were wearing protective clothingincluding used gloves in and out of the restricted area,including drivers wearing a single pair of gloves duringwork in the restricted area handling contaminated caterials,then wearing the same 5 oves out of the restricted area1to load their vehicles and start on their delivery runs.Personnel also availted themselves of access to and use ofuncontrolled restroc'ms and an unrestricted lounge wherecating, drinking, and smoking facilities were providedwithout availibility or use of contamination monitoringecuipment or recoval of protective clothin5 Dose dran-ing personnel were in some cases wearing a single pairof gloves to draw doses, then while wearin5 the samesicves, use telephones, c al culators, dose calibrat ors,

- packing shipping containers, and handlin6 prescription _

forms and shipping papers. Randon cuestioning of personnel.werking in the facility showed little or no understandingof:

a) the difference between dose rate and contaminatic...b) problems relating to contanination including

internalexposurehazardffromingestion,c) means of surveying for and controlling contamina-

tion,<

d) the linit as stated in the license for loosesurface contamination,

e) or the units used for contamination surveysand. reports.

.

The result of this situation was little or no control ofloose contamination either in or being removed from therestricted areas.

o) ~?aste Discosal_- r!aste from this facilities operationand waste returned from accounts was being separatedinto two Erouns for initial decay. Y!aste having a

'long"T and viaste having a"short' T . After the initialdecay, the waste is renoved to a bcsement stora6e

y. 3 .-<

A dose ~ r(ate at thh . time of trans--

e ; .. [ ,- area for . final decay'.-

. fer v;as written on a sheet - taped to the' outside of ..,t , the package and the packages were stored in. the base- 1

ment. This method has several: deficiencies, most. notably: ..

. .

a) there is no record of the volume of . waste or its~

radioactive material content availible short of._ copying .the iniornation attached to the pack-

-ages,_

b) the packages were not; grouped in storage by esti-mated tine |of complete decay,

c) the contents of. the pachages cannot be disposedof as is, even after total decay due to the manyradioactive caterial labels still attached to -the contents,

d) there were' no specific plans or' procedures forfinal disposal of ~ the .raste,

e) and there were no limits established . for accept-. able external dose rates at the time of trans-'

fer to the basement storage area.

Xe Ecod Deficiencies- The license annlication con-10) Eains specific recuirements for eouiphent used for

handling Xe-133. The availible facilities were un-satisfactory on several accounts including:

2.'

. a) noi6" arm ports :as required and as assumed in .

.the recuired iflor rate calculations _ subnitted -

in support of the license. application,-b) as mentioned previously, the required weekly

su veys' and filter efficiency deterninationshad _ never been performed,

c) the- hood was being improperly used in that itwas utilized with one or both windows fully.opened instead of viith one. side Lopened partial-*

-

,

ly and the other side closed which would max .;

imi ze the air flow rate,>

' d) the, roughing filter v.'hich the manufacturer recom-.

mends be replaced monthly had never been re-'

_placed since operations,had begun ten conths'

earlier, .;

| e) the hoed was being utilised ydth one section ofof the glass missing,

,

2) no determination ras ever made of the totaleDount or concentration of Xe-133 bcing releasedi

to an unrestrict&d area,. g) despite the fact that approimately six conths

earlier a 5calth ' Physics Consultant identifieddesign defects in the filter housing v:hich

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. allow.a large percentage of the Lpod airflow'- v '. . . .to bypass *the filters, no action was taken tocorrect the problem,

h) hood pulling capacity is required to be checkedevery six months or more frequently. I have-

found no record of this-being performed prior to-

my employment,i) the hood is required to- be located 35' from any

restricted area, it is much less than 35' betweenthe hood and the drivers lounge.

11) Customer Licenses- liPI is required to- dispense radio-active materials only to hospitals or physicianslicensed to receive them and to have on hand a copyof such license prior to delivery. The initial surveyof licenses on hand showed that in 32 of 37 cases,

- either the HRC or state license was incomplete, ex-pired, or missing entirely.

12) Hisc, Records and Recuirements-

a) Possesion Limits- Ho system or means existedfor verifying that an incoming shipment of-radioactive material nould not cause the facilityto exceed its licensed possesion limits.

b) Radionuclide Logbook- It .is. required that this_,

log shot among cther things, the disposal ' datesof all radiopharcacuticals ' received. It didnot show this information.

.

c) Radionharnacutical Lot Control Sheet- It isrequired, that7this log,chr- among other items,

-

i entries nill be made ."cach time" material .''

is dispensed. They were being made normally thethe day before, and sometimes well after the time

' that the material is dispensed. It is also re--

quired that this record will make availible -in-formation including the patients name, It didnot. '

d) Pre'scription Form- It is required to contain,

the name of the patient, The patients name isreceived after thf dose is utilized by the cus-tomer,

! e) Alumina Content- It is required that aluminaconten be checked on a daily basis on eachTc-99:;p'e"fdfeithat day and that no elution will

,

be used unless'it ' meets the requirements ofestablished specifications It is my belief that

| it is incorrect to perform this check afterthe Tc-99m labeled products are delivered to

| the final user.1

!

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, a A weekly check is required on each new gene-70rator received that week. This' check is re-' *'

quired to be performed by a dif f erent methodthan the daily ch&ck. This was also pointed

- out approximately six months before my arrivaland had never been ucrformed. In fact the-

facility has never had the neces $f equ,ipmenta

to perform this test,f) Particle Sizin5- This is required "where apt-

fropriate." There is no record of this havingbeen done despite repeated problems with thesulfer colloid products.

6) Package Receipt- There were several problemswith this procedure includin6 the following:

1) the license application requires thatthe chack-in be done by an individualuser, which is impractical,

2) the limits for action are given as10 mr/hr and 200 nr/hr vice >10 mr/hr'

and >200 nr/hr respectively,3) gloves are required to open packages;

they were not being utilized,4) there is a requirement that it be veri-

fied that receipt of the package doesnot cause violation of the posessionlimits for that isotope, this was not be-ing done,

.

5) a ripe test of the. final container is re-quired; this .'as performed occasionallybut normally by a method other than thatspecified in the license application,

6) and it is required that packaging mater-ial be surveyed prior to disposal, thisnas not being done. ,

'' h) It is required by the license application that

a dose calibrator will be recalibrated or" rechecked" if a calculated dose does not co-incide with an actual dose, this was not being

~

done.i) The license application sqts forth the maximum

activity which NPI is allowed to ship in asingle shielded container. This requirementwas being violated by approximately a f ac torof three on a routine weekly basis.

j) UPI's license amendment 401 requires that IUDdrugs be shipped only to physicians viho havebeen accepted.by the manufacturer and that thephysician be give certain information. Therewere no records or procedures to insure thatthis happened.

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'exuosure rias received, - :hether or not the individuc2

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~has ever rec *eived an overexuosure to radiation,oeand whetheror not any cedic'al restrictions existwhich ni ht affect - the individuals ability. to re-5

'

ceive an occupational - radiation exposure.d) " Request for Occupational Radiation Exposure

~

Records"-- This a form letter to be used to obtainprevious exposure history on an e=ployee,

e) " Occupational External Radiation L:rosure History"- .

This is a facsimile form NRC-4 Thus meeting therequirement as to the format for recording previousexuosure history and for calculating current allovi-able erposure,

f) " Current Occupational B:ternal Radiation Exposure"--This is a facsimile form HRC-5 and is use for record-ing exposure for all' employees at p;.-l.

g) "Dosinetery

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