ML20031E242

From kanterella
Jump to navigation Jump to search
Advises That Refund for 801112 Application to Amend License 37-18461-01MD Will Be Sent as Soon as Possible.Related Info Encl
ML20031E242
Person / Time
Issue date: 01/21/1981
From: Gerard Jackson
NRC OFFICE OF ADMINISTRATION (ADM)
To: Fulton J
NUCLEAR PHARMACY, INC.
Shared Package
ML19242C613 List:
References
FOIA-81-301 NUDOCS 8110150263
Download: ML20031E242 (3)
v • d • e


Text

,.

g j 'f,.;,

.(;7[ g o....w.,,.~.,

(3) p, NUc., JAR REGULATORY COMf,11SSION

~

.f_.,.Q:Syg namn. o. c. 20s:s f : sr a e

-)

. %>'.%*) y/.

/,J //

Nuclear Pharmacy, Inc. for Elfreth Alley Apothecary nttn: James M. Fulton S

31-33 North 2nd Street Philadelphia, PA 19106 t

REFU::D OF APPLICATI0 ' FEE 1.

BACKGROUN9:

Check Received 11/26/R0

~

Application' Dated 11/19 /on Check Mumber 207R6 Check Amount 140 2.

REFUND:

/nount

$40 This refund is now tain.g crocessed by the Controller's office, and will be sent as soon as possible.

[

3 r 3.

REASON FOR REFUND:

Ef Request dated.11/12/80 for an amendment to License 37-18461-01 MD plas comb ned i

g with request received 12/2/80, for which the $40 amendment fee was paid as specified in fee Category 3B of SE:: ion 170.31,10CFR 170.

/I Glenda Jackson License Fee !!anagerrant Branch

(

Silver Spring Office g

Office.of Administration 3-

[,

U f

y i

r I

~

8110150263 810112 i.

PDR FOIA j

i FARNARD81-301.,PDR l.-

l

$" hit.?J'"'

.. -.- =.=. r 2%'fell,"\\,'b"

- p (d:-

N sjLL FOR COLLECTION

~

?

3 ;11 3,,

{

U.

'S.' Nuclear Reculatory Commission 1

Daic _ 3/17/30 co p.ru.e i or t iahi.hment. a sore..., omee) 7 (Address)

PA YER.-

Nuclear Pharmacy, Incorporated Elfreth Alley Apothecary Tu, sur,4..is 3,,,,,,,,, 3,,3 2720 Carlisle N.E., Suite B

  1. v'r'=u4 Me<<-ut. =.

l Albuquerque, New Mexico 87110 SEE I.VSTRUC7to.ys 3Et.ow, o..e DEsc.uPTION Quantity

}

h p

t 3/7/80 Payment on Civil Penalty by Order 4s000 00 i

dated February 19, 1980, Letter and Check to:

Accounting 5 Funds Branch, CON L-316 ccs:

J. P. Murray, ELD, 9604 MNBB T. W.-Srockett IE Files

/CentralFiles civil 17enalty Book A.%IOUNT DUE THIS BILL, S 4_,000 00 This is riot a receipt INSTRUCTIONS Te= der of payment of the above bill may be made in cash, United States postal money order, express money order, bank draft, or check, is the ciEce indicated. Such tender, when tn any other form than cash,, should be drawn to the order of the Department or Establishment and B.:r-au or Office indicated above.

R:ceipts will be issued in all cases where ** cash is received. and only upon request when remittance is in any other form. If tender of pay =ent of this bill is other than cash or United States postal money order, the receipt shall not become an acquittance t.atil such

~

tender has been cleared and the arnount received by the Department or Establishment and Bureau or Office indicated above.

Fa2ure to receive a receipt for a cash payrnent shoald w promptly reported by the payer to the chief administrative o!!icer of the bureau or agency mentioned above.

U. S. CoVEP.H4DET PR.N., TING CrricE :1974 o. ss2 2,0 4~>

?'

w

' ~'

s.

3 1

1*

r

.t y

s.m.

J' fQ t

\\

e s

, 5% ~ --

v-

"-~*: : :- --. _..__.

,-?'"

t : "',

.....~.... ~..

W._

e......

    • '*"*-.......-m,

.. ~.

.,._..._,_..~..~,.,._

...p.;..., _i...i._.."..

..,.:..,i..~

.~.w. ~...

.s w.

.. ~ ~.

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

..__.u.,

o... _..

1/;;..'/;. ;

_. - _..c

. t : _.. _...

__.r-o --

. Citizens Bank of Alb...

.. a

. o ll Aieuq q

New M..e.x. ico...

CaS h. 1.1 -ie rs.

."~.m. _...2f;... _ p.f. ;.

iZenS uquerque ;

-9

- + =....-

O gg k.

. ue.r..u.e.

l MOC... - - -

BG.

~.

I ! -~~N......

~~

, :....:...,., :i _.... '_i_b;.__i '"* i ~~

.' ~ '..~:~.

-- --- ~

-.,1 i-il:-

O '- ~

9 5E_ ^

E3

~

.. -.. $ s...

...f...

,.-- 1070

........,..so

_.....,....~......1..

a

&--._--___.m

_~ m _ __- _.

.....t. ~..:......s.:._....:....,..s._...... ~.... - ;..,.....

i

....,... - - - i

..g;-

r

.i

.j{..g

.,.g. _.,.;....es.....s

_g,

., _. ;, -;, g.,j y ty {g g.

I..

,.,i. - ;, _, ~.,.

......gg-

%.^r of,i.

t

.ji....-.;.

i;

  • * * * * $' A h f.a kf* 6. ;j,,,

t-

. ;, _ ; -.,,. i. ! *.. Q a r. r. I ra t n t r s..

'_,;*,l-

.,,, - - ** t**...

_ *~

.. _.- + +4 4 4 ****t t n f

  • n ri t

(*rw vn iceinn temene. M f t r.1 pin e.

~'

n o t d-a

. - g.-r p..,.t,m g bu.._....i

...t.,

,.4.w...s.

v

.,.y 1.

s...

.g..

-. m.v-....l.is

.t,...:..

,.--- ;: ~.-,;;;.._.;..

.. ~. ; --~ l.. '..... ).. c. : s.... :

.it

-e,>

2gs g

,;....i.._,..__;,___.

... 4.c -

y

..g

.. _ ~..

.~w,y;.....# m.,.

tg

.~

p

,.,,,_i.

y..

., cs g,i.,.v.v.

,.3

,v..

. l. _..

- 1,7,80._._

. -.....,s..s..

,.,,,, _,,, r. 3 3 _,_e..,_

i

.....g..

...e..:.... ; ;.

.-. ~ _...

.g.,..

.~.

3.

. t.i t

Nuclear Pharmacy

.g

-.,p.....

L.. -. Date

.. g,.

inco roera e.d.

1 w /_u

~

m - -- ;

. ~ ~ ^

.. Authc.*ized Sig Jlure'._ '.. ~

. mitt'_r

_P

__g..~..-

._.. J o_.....

G P.M. --' r _. _. _.

pB4GGhe ~i:lO70008Gbi;.. OP 00001...

r e

.-_...4...:...._..............-..3.

.~...

_.4

- 3 6.-

e

... ~

.7_..

..; ; C ~*.

v

"~

- n.

~

r

.4

.4 v-

-e

..M

~

s.M 1 l [

2 I,s

  • ;- )y'.l,

.e

,f L

.y

!.n Ma
.ggy.
ip.. 3 -

3*.d5

. n

>gm.

l~

" /q3.7),

U.

APR 7 1980

~

Docket No. 30-15125 Nuclear Pharmacy, Incorporated License No. 37-18461-01MD Elfreth's Alley Apothecary ATTN:

Mr. Robert Sanchez President 2720 Carlisle, N.E., Suite 8 Albuquerque, New Mexico 87110 Gentlemen:

This refers to your letter dated March 10, 1980, in response to our letter dated February 19, 1980.

We acknowledge receipt of your check in the amount of Four Thousand Dollars (54,000) in full payment of the civil penalty proposed in our letter refere:'ced In above, and your letter informing us of the corrective actions taken.

addition, we expect information concerning your management controls and audit program on or before May 12, 1980.

Based on the results of future inspections of your licensed activities, including the implementation of corrective actions as described in your letter, we will determine whether any further enforcement action, such as modification, suspension or revocation of your license is appropriate.

In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2 Title 10, Code of Federal Regulations, a copy of this letter and the enclosures l.

will be placed in the NRC's Public Document Room.

Sincerely,.

- ~.

-~.

' Original Signed 37

' ~ ~

Q7 R.O.DeYounE'-

. F.

Victor Stello, Jr.

Director Office of Inspection 30 f~l and Enforcement

[O fyp cc:

Mr. Nunzio DeSantis, District Manager r

Elfreth's Alley Apothecary 7

/

)ff".

31-33 North 2nd Street m

Philadelphia, Pennsylvania 19106 E(]A' h

)

r t

D X005 ODRC Voeng VS 71o' 4 f

WPU:SM XOO FF 4/1/80 T-ckett TR e

r ' ek JLie erman DThompson 4/*/807-

,7 JOB E(3) 4/ //80 4/ /80 0

4/> /80 4/ /80 4/g/80

=..

i m,~

\\

li44 n g.t

..r. e 3

ML

GU Q

LAW OFFICCS CF

~

. StrrIx, THAYER & 3 ROWNE A PROFESSIONAL CORPORA 710N mamaw am C

a LCS pasCE I:1 STEP *CN CHARNA$

MCVIN V. RCILLY POST OFFICL dos s94g ce",*.*J * "I&":'"' "&".% "e"'.".'""

^'*" " *"o" c ~ c- - c ac o. " a l'"'M,cV;.iti^."'

"%"o'**.T*M.'c..

' '"*o JAf 3.MENIZ A LISC N OSCMULER-eCSERT G. MCvemos moNato stagt 3

ALD L.JONCS M CM.CL

, Syf N D ' * $ 8 'M 9 WCN%C F R A N R LI N J.O.N E.S.

N O RM AN. S. T he A F C.2

..N,OS,T O'FtCC eC a,ee p P

N L

.,c...

L. c.... u.

..N..

...C. e....

'tTJ"J."t'n.

i:'.".' t::";i".
  • * ' ~ " - -

E',*c't c.'oC" March 10, 1980

~

CERTIFIED MAIL 1

Mr. Victor Stello, Jr.

Director, Office of Inspection and Enforcement United States Nuclear Regulatory Commission Washington, D.C.

20555 Docket No. 30-15125 License No. 37-18461-OlMo

Dear Mr. Stello:

We represent Nuclear Pharnacy, Inc. ("NPI") concerning the February 19, 1980, notice of violation and notice of pro-posed imposition of civil penalties which were addressed to the Elfreth's Alley Apothecary in Philadelphia (the

" Apothecary").

We enclose a cashier's check in the amount of $4,000 in full payment of the two proposed civil penalties.

4 NPI does not agree that the TLD ring badge exposure read-i ing of 68.322 rems referred to in the notice of violation accurately reflects the employee's actual hand exposure.

l As Mark Browning, assistant lab manager for the Apothecary, pointed out in his December 28, 1979 letter to the Region I Office, the high exposure reading may be ex-plained by inadvertent placement of the ring badge in a i

contaminated area while not being worn.

Each NPI employee I

is instructed to monitor his dosimetry badges, his hands l

and other areas of his body for possible contamination l

throughout each work-period.

In the Contamination Control l

portion of the inspection report for inspection j

30-15125/80-01 the inspectors noted that NPI employees at the Apothecary do comply with these procedures.

However, t

i s

0g40# j/

DD 1f0

/

  1. (z-

~

r,

m wi w ia

?-

O e

/

Law o,F6C C S OF SuTzx, Tu.wric a HitonE A PftOF ems 80N A 3. Co ts PORAT20N Mr. Victor Stello, Jr.

March 10, 1980 Page Two NPI recognizes the importance of maintaining radiation safety for its personnel, and the seriousness of any pos-sibility of employee over-exposure.

NPI will therefore pay the S4,000 penalty without filing a response challeag-ing the proposed imposit;on of civil penalties.

As a result of the January 19, 1980 notice of violations, Steven Dessel, manager of the Apothecary, posted a notice on January 28, reminding the professional staff that the use of syringe shields is mandatory for kit preparation and dose drawing.

Each professional staff member signed that notice to indicate that he or she had read and under-stood the notice.

A copy of the notice is attached to this letter as appendix A.

On January 16, 1980, Mr. Charles Stephens was employed as radiation safety officer for the Apothecary.

Mr. Stephens is a health physics technician, whose previous employment involved safety inspection and supervision of pressurized water reactors.

Mr. Stephens has no responsibility for pharmacy operations other than as radiation safety officer.

NPI has also empioyed Mr. Robert O. McClintock for the newly created position of Director of Radiation Safety and Regulatory Affairs for NPI and its subsidiaries.

l Mr. McClintock will begin his new job on March 17, 1980.

Mr. McClintock has a Bachelor of Science degree in physics from the College of William and Mary, and a Master of l

Science in radiation biology from the University of l

Rochester.

He is a certified health physicist and a cer-l tified safety professional.

Mr. McClintock has 24 years' experience in the field of radiation safety, including 7 years of regulatory and government work.

Because Mr. McClintock will be bringing to NPI a back-ground of experience and expertise in the field of radia-tion safety, NPI requests an extension of time in which to l

respond more completely to your concerns about the need l

for an ef fective managment audit system to arsure radia-l tion safety in each of the NPI pharmacies.

Mr. McClintock will evaluate safety procedures in the Apothecary immedi-t ately after beginning work for NPI, and will review an l

ALARA type audit program which NPI has proposed for use in l

l l

l l

7 U

Law OFroCES OF SUTrx. Trt.wnu a Duowxz A PleOFEustOMAX. CORPON.ATION Mr. Victor Stello, Jr.

March 10, 1980 Page Three l

all NPI pharmacies.

If you will grant NPI an extension of time in which to file a more complete response concerning future methods of achieving a higher degree of radiation safety, Mr. McClintock will have a complete report befo e you by no later than May 12, 1980.

Thank you very much for your consideration of this request.

Very truly yours, SUTIN, THAYER & BROWNE A Professional Corporation By 7fw E /// SCo>,o pryE. Mcdonald MEM:dkt Enclosure cc:

Mr. Robert Lee Sanchez Mr. Steve Wilkerson g;.

,U' Mt 4

e

.,,-,,.,n.-.

<,n-n-

-,,--e.-

..,,..,,,...,a.----

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

,v...

,-,--.,,n-

,o n -

~ ~ '

Y XIGN3ddY m.. o

.A.

e a

wi w

e,.

i.

2

.e

.e e,.,.op.,.ev

.t.

we

,0 c

s n. e s. e9.., -

~

=- pe s

e.e w e..e.o.

3

%, 8 w-

.a o

h, a

en.a

,.,u,

e'-

q**

.e e c..,4 n,e P

p t. 4

m. e a *.n.= d ame y
  • e e d a b.

6e

==

- -. - ~~~

e "h 9b 6

w=twm p e s a.

beoew

.t.9 s e. e a o %= t

  • ', e. M A e.
m. n aw g

a ea e 6Ae o es.* p.e e 2 4,e-eae e

e

.e, 4.

e s s.

ae

.e 4..a es e e. e.e.

w.,

r,

,a. se. o. e e se ee e no en s

4,,

., >.a i.e e

. e n.

e e

.p e.s.

.a w 6..e 4

  • w,6.

mm n g me e e.

a.

e.,e

)

e

\\

e w.e e e. e,a.

Ne k

e.s co e t.a 4 s

a

. o es i

e a

e m

7 (:

N A e.e a.a -a, h.

3,a a e a

.m a. o es eee es a

.= a e.ar w

e eo 2

. e.s w

i ecawee s e

2ee e

i a.,*~

5.

A-4 w e.a s e.se e

l.. a.

.e a.e a e. u eee r

o

~.

e en u.

a av

-ee.e

'w.4 a' es e s e

ee es O

e s e.s.,.e. 6 an34 e

=

j a

h wa m a.h. 4... s e p u e4.

o e 1.

7 A

as eae

.e

.4 m.

ge

>m9 wa>ek

.y W

.I..e. e. z w w r w ~. w e

.a.

e e

p ee w ss. *

e. e e wue,w se d'

%s-e.w e.a..e.*.e

> 3e oh O

fi J s a w

= =.

  • 42 e.*

ee at *

,L.e= r as e a.O.* a

r. es G e.

e e, es am. es e

ne d,eL d

N. '

e a

3

.a z e

2 ee e

e e ae e e 6.e m..e..a v a

fu een h -

a g

ee

.3 s3 e e

..e. s e a ag te e f

4 t

e a =

at y e.

.sp a. s e s

'd e =P uo to a e... = ee

=

.we m.

e an. q e,

e e

ste e e.e c o. e. ae e

n e

46 AL s***

a w a..s s.13 7 h

s. o.a.w.e.g,s.o.

d e

a3 CM**3 ed C es e en 4

6e4. a e a3

. i eeav iee

e. +1 ao

<= e e-se en e sa

n. e e

v ce d

  • e e. e e= =a.

e

.e. 4, e

$ $ a.e.e e

y.e.."A.e h e ee ett e a e4 4a a

e ee

    • e e o, w.

as ol

.s e s.e Y

W emme e e P '

a w e..e.n a.

a

n. e e. e *=ed e #1

.e. o.e q s ee le =.. e

2. =

.B e E4 e g

.e.e.e. o 8e 6,

a e

e p CA 9

e oen af

.* e e

.8 4 i e 4

r e*eeo es s)

,o,

,e y au g a 4

=*6.au}& 9 ene e as h at e9%

e R

e 4 r v.

o.ea9ew 4e e se n

d., e e.

e.e R

se s q.m.

e ea o e

a.

.,e

. e.s.=.=.

e.9 e e

e.

m.E M de.e a*F **

.e.

s=

e o

8 e e o

.o.= ap e. 4 s"2.* e 4

W

  • O.h..*

ee e

e>

e e Ck,

4..e.

p"4,e e.

3

  • T 4 's 5 48 h
  • a n. e e e.w o

g s e e e a

a e

.e.

.e

  • s.d. a,a a.

a ea an a e t

.=

a. e e e o

ee a

se eoW3e i=

w o 44

  • 4 e

o a,

e ye es

=

..e.

ce oes s.s u w eua ae k u 6,

.** e o ee p.*se.3

s. 2. e*ee*

se g e* 3 o e d

      • ~**

g% E.4., 3'*

e b te e

e at e

.e g e s tm,,

g e. e,h m- -

b 4

. e s.w e

e

.- 'e W

  • e E sa E Ed et omoeoee se e4 e

,es Te e

e e

we he. e

.e.a e.

a. ve en h e.e.

e

.4 o

Se

( a e

e ee t4.c'eto.e. o e

he3

.e. e e

c

.eod b e4 o

(s eeA4 5,a e

.e e ne w.e.t.A e ti 6 e$

4 EB em.e,3 ** o.& G.& e see.h se e.e. e.

n en ed &.e O.A e e

g, e

e e

d. d. O

== h a 2 a..a e e a es ez a

  • e be be e e.e.

ee as a es e o e t e e> e es t. em.

a. v, o 7 Sea 2

e e e og e w e me

  • ze 4 e.q go.w

.e. o e.,.l e v.e AS.m.e.I e SO e, )

g e.

e

.e e o. See ee.e. b e. e.e a==

we o

.e we e of e w

.e e n. e o.

s

=Amo e

z e.u to c.e dee

a. o en e f

an e

e en te e

6 e,e $ *l

.s.e, o.,e 9 e e 2 as e e

  • <
  • W se ems.c. e at= 4 m. se e.,# *

==

a a ew ee e

M po ed

    • ,B.ee.e. *.e es e e.se.t we e.

e.se ne

.e.8

      • 4.e a

at e,e w e ce oeae 2=4 9

to s. e. e a e e.m e 9.

    • I,e..o J.

.N e t. 4 e e e, e.* *e w

e== ce se as e w ei o em t e6 e e..s.w a..e. E89 0

~~

A.e eO t. e,e 4

e e

t..s 4m.s 9

eo aee e

e..e..e.*

et e %

.c.e. 6

.t.o e e

+,

en g e al e.4..e..e e a. e.

u oew wes u s. e og e

ea we e

.o e es v e e. e

.a.m.t e e me 3 e e

a eaw e ww e > a e a m e.n.

    • ne e.

e es se.J e ase.m => = = c e t l

~ =

me o

.e..n.en e e. e.

a ea

  • e.m..e e o e 'I.e o me t o
  • en e

i e w e.e s,,

e.o. l w e.e.e.s,a. ee o to

.e 4.-

e

  • s *L.ee e.o
  • w es e

e.

e me e sne.e e.o e.e e

6.

se g

A a.b ee e.

a6

  • 9. > ** e ce t. e. %* **

e * *e *eT ee

' ma

.e.

h a o. a se,e e

a.,e = e. a r e

es me

.a me a

. m9 e

7 as e a e = ew.o..o Op me. a.h; es a e sd e e

e 's e e n.

e. e ce C

.$ e e. O.be

.a h ov's c n.e en e e

he es ee te a a e

ee w w, E

    • k e

e si ea e e a

an e a.

eoe

~.e'g( S e o C Y.ea e. n a a

en e

d a w u g a g w.es A% sa M a

6 ad e.,

s. e se eene m e m

h o es e

e. ee.e, T m

e e

pwe

.sg te se a. d. hs at.e e,

n e

.e e

e' e.

n q

h.a.e.es.a. e a J.eE. m. 4.

s..a es c.e.

eee M

aJe es e a ee

.e he t ?4

e. eg g e,.s se e e e m EE g e.

et A o

e *.

6 ee w a.e..e.m.

ee an o g

. ed e *4. se

.e. s. m,e o.w -e

  • 1.e.e, h e e.4 e se e.b e e.Ja

. e i e me gs

.e e

5 A.

,3, 2

.e

,, e e

as ha se a w e e.t.e. e.nn,.d v

e o

  1. .f A q

e e

eeao a e s.

d.e sa 8.8.4.n.=e 4,e e c

w e

e na e e..d sw.=.

es

,4e e.me

,c%

p.e e as.e. on eo M, se.e e er e

w,,

.e e

m.

e e. e A.

e e

a: g oe e

e

.e.e m &,.R. e ed

-*,.=$.v. p h a.

Y

  • C

.e C

e.

e e.

g

  1. 35g e

L.e., e a h a. ?. y e

o=

i e

e.

.3..e a. e 9.e.

a s.

.4 ee os 3 s e.

e.

o e

=

e ex e

.e e

e e

o e ev at 4.

6 k. net as to 6

.e. es e a e -se a e e.k. e 4

== 3h e se t c

8. W m se c se D.e..e.

== ef.

.e es e

ew

  1. b.
3. e af
e. e v.*.

3 he ep g **

  • 4 ab e e.

3 ae e e e af ce e e.e.e e. e WP.e

e. ew m.e 9 4

h te c A

e te = w 1p h

e 4

.e.

.e a. e e. e ** 6 e o se D. e es e

e e,

e a= =

be.e 9 W.e e e h w e, a ad

==

.e ee b E=

e e a en 8 1

81 A es e A. e

.e E e to e a A.e

.E 9, A.

  • =* e c.6 e o

.e e e

D gp v ag Dee e e C w *e ** h E g b) $.s e.

'9 e

hW e

e e ne J

  • =.

em

  • A-6.A.es e C e,s N

88 %

m e,

e

&.a e e, s

e E

e

= 0 or e

.e D E fe M

fe 4 Es O e e me e 4 e to e

=.

._..b...

.. 4 w

,v. ;

+

-s

.._.y.

j p

.7.___

_g

-. - r

. -... ~ - -... -

h 'h ~~Y:'

L. _.

i.

5. A'-lT_ '.-:.. --- : T =tg :~-~'

.==..O ;-.~. y :.~..-. f:..{\\ *a -.,-~-.. ~

2 --

-.. ~

-~w-=-

  • . = V '. ~ L-1:. -... =.. -&

C.

- :-=-2:..- -

. :7 "Y1-

' -- ~ =--

7 ~=.: t.-._. ; -- -- - i...:.=.2=

- y "Qff.{-.

' Ydl~5.[-?--k*.f:M.

h 9 ikQ $f '=. ~: '.2.'.-

~

-...... 3-3 y.

3

~

~

Nuclear ?har:::acy, Incorporated Docket No. 30-15125 Elfreth Alley Apothecary License No. 37-18461-01MD ATTN: Mr. Robert Sanchez President 2720 Carlisle H.E., Suite B Albuquerque, New Mexico 87110

~

Gentlemen:

The eparent items of non' ccepliance' listed in Appendix A to this letter which were identified during our inspection ~ conducted on January 22, 1980, of your licensed program at your Philadelphia, Pennsylvania facility, demonstrate that licensed activities are not being conducted with. adequate concern for the health and safety of e.ployees of your facility. The nature and nu:ber of significant items found during three inspection; sinc' you started operations e

in April of 1979, are evidence of a lack of control in the area of radiological health and safety.

Your inadequate radiation safety program has resulted in excessive and unnecessary exposures within a short period'of time to the han's of individuals working with licensed radioactive material. This is not d

acceptable.

Consequently, to assure that appropriate, timely, and lasting #

corrective action is taken, we propose to icaose civil penalties in the cumulative a=ount of Four Thousand Dollars for the items of noncompliance set forth in. Appendix A to this letter. Appendix B to this letter is the Notice of Proposed I;:: position of Civil Penalties.

You are required to respond to this letter and in preparing your response, you should follow the instructions in Appendices A and B.

Our concerns e'.,ut the need for an effective canagement audit system to assure safety of yc e operaticns were communicated to you in a Management Meeting on July 10,1979. Numerous and recurrent items of noncom'pliance since that l

meeting indicate that your audit' system hs not been effective. Therefore, in your reply to this letter give particular attention to describing those actions you hava taken or plan to take to iEprove the c1anagement of your l

radiation safecy program.

~

1 Your written reply to this letter, cocbined with our findings from our continuing inspection program, will be considered in determining whether any further enforce-i sdis.t action, such as m:dification, suspension or revocation of the license, is ao:copriate.

i CE?.TIFIED MAIL 7 "l O!

R: TUP.N RECEIPT P.200E5T,ED o01 M

1 l

~

9 0 (2.,.

u

/.

~

J

- n.g :.

+

?....~ -..E1freth Alley Apotheca)ry ; '. '..

g..-

=. - - -

. =.....

..;-... _ r.. '

~'

-5+. V _. '-)EB 19 1330

~

-.'~

J j

' '%5:.-f. %'. -

l.

=-

l In ccordance with Section 2.75u of the NRC's " Rules of Practice," Part 2, a

Title 10, code af Federal Regulations, a copy of this letter and the enclosures will be placed in the NRC's Public Docusent Room.

1 Sincerely, Origir.21 Signed by V. Stel:3 Victor Stello, Jr.~

Director Office of Inspection and Enforcement Enclosu'res:

1.

Appendix A, Notice of Violation 2.

Appendix B, Notice of

.Preposed Imposition of Civil Penalties cc:

Mr. Nunzio DeSantis, Dist.rict Manager Elfreth Alley Apothecary 31-33 North 2r.d Street Philadelphia, PA 19105 4

Distribution PDC J. Cooks, OMPA u.1 ;

NSIC G. Snyder, RI SECY

. V. Stello, IE T. W. Brocket (, IE IE Files D. Thompson, IE Central Files CA (3)

CP Book

~

J. Snfezek, IE CON F. Ingram; PA X005 Reading File J. P. Murray, ELD EDO Reading File J. Lieberman, ELD Xy Miller, FCML - 396-SS Jerry Strickler, OIA - LA-1200 y/.im

-E k.-7.E:IE A:ps:IE A:00.IE ' D:IE WPU:DM 2/7/80 prockettTNr GCuch'o er DTh pson VStello msen

...ezek cerr.an Job P(2) 2/g/80 27 /30 2[ g 2//'

2/l 80 2h3/80

/80 4

1 4._:,... : r. v : e --O.t.2.c..<.:.. 3.,

, " " ~

f

.;....w

...... s,. /.a...

-s

/+ c-.e; c.xm..~.:a J"..~.;FEB 19 E80 J -":t..

5

. 7.. 7." p.L.la.... zj_:.p, #

- p.iy,u ~,..m

...u.....=

. w

. - -c - -- ; ---. - - _p ;.1.- c. -

-- q,pt :. APPENDIX A ---

Sr

. ' +N

.!.3.,. 1,,

. Q.: NOTICE OF VIOLATION 1.'.' ".

'V..

- =.:. ~. : ---

m: - -.. -..

y,.

~ : Elfreth Alley Apothecary D~

Docket No. 30-15125

" Nuclear Pharmacy Incorporated License No. 37-18451-01FD s

This refers to the inspection conducted by representatives of the NRC Region I J

~. (Philadelphia) Office at ycur Philadelphia, Pennsylvania Facility of activities -

. authorized by HRC License No. 37-18461-01HD.

~

During this inspection conducted on January 3,1980, the fol!owing a;; parent items of noncompliance were identified.

A.

~

10 CFR 20.101(a) licits the' extremity dose' that an individual working in

a. restricted area crty receive to 18.75 rems per calendar quarcer.

Contrary to this requirement, one individual werking in your restricted area received a hand exposure of 63.522 res during the fourth calendar quarter of 1979.

This is an infraction.

(Civil Penalty S2,010)

B.

10 CFR 19.12 requires that you instruct all individuals working in your restricted area in the precautions and procadures to minimize exposure to radioactive caterials, in the purposes 'a-d functions of protective devices employed and in the applicable provisions of the Commission's .

regulations.and licenses.

Condition 20 of yeuc license requires that ;icensed materials be possessed

~

and used in accordar.ce with the statements, representatiora, and procedures contained in your application dated Novecher 6,1978 and letters dated February 14,1979,' February 19,1979, March 12,1979, and March 15, 1979.

Item 10 of the encicsure to yo:+ letter datad February 14, 1979, requires that syringe shields be used for dispensing operations.

Contrary to the above, on January 3,1980, the inbividual who had received the overexposure during the last calecdar q2arter of 1979, dispensed millicurie quantities of technetiun-SSa w-itiout using syringe shields as required.

In addition, the individual wIs r:ac adequately instructed to use syringe shields in this activity in that he was not infor=ed that it was a license recuirement to use su-h shields.

This is an infractica. (Civil Penalty 52,030)

This Notice of Violation is sent to you pursuant to the provisions of Section 2.201 of the N?.C'5 " Rules of Practice," Part 2, Title 10, Code of Federal Regu-lations.

You are hereby required to submit to this office, within twenty (20) days of your receipt of this notice, a written sute:ent or explanation in reply, including for each itsa of nonco pliance: (1) admission or denial of the alleged item of noncompliance; (2) the reaso:s for the item of noncompliance, if admitted; (3) the ccrrective steps' which have been taken by you and the results achieved; (4) corrective staps which vill be taken to avoid further noncompliance; and (5) the date wilen full compli nce will be achieved.

Y 0

..: w

.; :9

~.

.x.

^

-~

[7: &..;{-2.~

'.'? O.

u -+: -;._:u.k.,.{f 5

'... 3. - 3!r--.,

~

2.

FEB 1S E30

. g y.-

.-. =--=

.... ;w..

M. r:: :... q :.

-w-

~. m.y:.n...

s..

APPENDIX B

~ '

.' - 7 "

V E l.',' ~. 41 NOTICE'0F PROPOSED IMPOSITION OF CIVIL PENALTIES

  • Elfreth Alley Apothecary Docket No. 30-15125 License No. 37-18451-01MD This offica has considered t'he enforcement cptions available to thn NRC including

' administrative actions in the form of written notices of violatioit, civil monetary penalties, and orders pertaining to the modification, suspension or revocation of a license.

Based on these considerations we p-opose to impose civil penalties pursuant to Section 234 of the Atcmic Energy Act of 1954, as amended, (42 USC 2282), and to 10 CFR 2.205 in the cumulative amount of Foud Thousand Dollars

- ($4,000) for the specific items of noncomplianca set forth in Appendix A to the cover letter.

In proposing to icpose civil penalties pursuant to this rection of the Act a'nd in fixing the proposed arount of the penalties, tM fac-tors identified in the Statements of Consideration published in the Federal Register with the rulecaking action which ad:pted 10 CFR 2.205 (36 FR 16894)

August 26, 1.971, and the " Criteria for Determining Enforcement Action," which was sent to NRC licensees en December 31,197?, have been taken into accoun't.

Elfreth Alley Apothecary may, within twenty (20) days of receipt of this notice, pay the civil penalties in the cumulative arount of Four Thousand Dollars (54,000) er may protest the imposition of the civil penaltiu in wholb or in part by a written answer.

Should Elfreth Alley Apothecary fail to answer.

within the tin specified, this office vill issue an order imposing the civil penalties in the amount prcposed above. Sht.uld Elfreth Alley Apothecary elect to file an answer protesting the civil penalties, such answer may (a) deny the items of noncompliance listed in the Notice of Violation in whole or in part',

(b) demonstrate extenuating circumstances, (c) shew error in the Notice of Violation, or ~(d) show other reasons why the penalties 'should not be imposed,.

in addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigatien of the penalties.

Any written answer in accordance with 10 CFR.2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but raay incorporate by specific..

reference (e.g., giving page ar.d paragraph nutbers) to avoid repetition.

Elfrath Alley Apotheca y's attention is directed to ti)e other provisions of 10 CFR 2.205 regarding, in particular, failure to answer and er. suing orders; answer, censideration by this offica, and er.suir.g orders; requests for hearings, hearings and ensuing orders; ccmprcmise; and collection.

Upon failt:re to pay any civil penalty due which has been subsequently determined in accordance with the applicable provisions of 10 CFR 2.205, the matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be col lected by civil actica pursuant to Sec, tion 234c of the Atomic Enercy Act of 1954, as amended, (42 USC 2282).

ADL

%CO 2q^

C

-
Retrieved from "https://kanterella.com/w/index.php?title=ML20031E242&oldid=4598753"