ML20212D594
| ML20212D594 | |
| Person / Time | |
|---|---|
| Site: | 03013426 |
| Issue date: | 11/30/1982 |
| From: | Delmedico J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Brown PROVIDENCE HOSP., ANCHORAGE, AK |
| Shared Package | |
| ML20197E946 | List: |
| References | |
| NUDOCS 8608120536 | |
| Download: ML20212D594 (36) | |
See also: IR 05000178/2038001
Text
V ~ . > . .
mi.4,, w~ \
UNITED STATES
Mes dY ~' _(p*,
-
,.
jeS "G%,g?+, NUCLEAR REGULATORY COMMISSION
,
,.
)
, WASHINGTON. D.C. 20555
"
%.....J 11/30/82 .
~
..
e W
Providenne Hospital
ATTN: Mr. Brown
Assistant Administrator
3200 Providenne Drive
AnEhorage, Alaska 99504
Dear Mr. Brown: ,
<
Linense No. 50-17838*01
Your li6ense for mediaal use of reantor produaed radioisotopes expires
Marah 31, 1983.
If you wish to aontinue your radioisotope program, you should Eomplete
and return the en61osed prea printed renewal appliEation at least thirty
..(30) days before the expiration date.
Note that the appliaation form has been Eustom prepared for your
program! Usually, the form requires that you supply information on only
four items. This should save valuable hours of staff time for you.
The preprinted se6tions spe61fy the minimum radiation safety program
that the Nuslear Regulatory Commission finds anaeptable for mediaal
programs. Our experienae has shown that this usually eliminates the
need for additional Eorresponden6e and speeds the renewal proaess.
Before you sign and return the applination, your radiation safety
offi6er should review it Earefully. You must be 6ertain that you aan
follow the proaedures and frequenny sahedules des 6ribed in the appliaaa
, tion, sinde they will be6ome a part of your linense.
l
It is possible to speEify 6hanges to the preprinted proaedures by ,
following the instru6tions on the aover page of the appliaation. If you
have any questions, please telephone me on (301) 427-4232.
Sin 6erely,
l
Joseph DelMediao
8 81{053g860616
P
50-17838-01 Division of Fuel Cyale and
Material Safety
Enclosures:
1. Preaprinted appli6ation
2. Regulatory Guide 10.8
,
W e'
.
, n. .. .
.
INSTRUCTIONS FOR USE OF THE PREPRINTED APPLICATION FORM
te
This preprinted application form specifies the minimum radiation
. . , _
safety program that NRC finds acceptable for medical programs.
-
You may specify changes to the preprinted procedures provided
that they are at the same level of detail and offer the same
level of protection.
printed form. Do not make changes directly on the pre-
Identify any changes or additions in the form of a
letter that is dated and signed by the hospital administrator.
Refer to each item that you wish to change by page number and
item number.
'
After completing the application, make two copies. Retain one
copy. Forward the application and one copy to the U.S. Nuclear
Regulatory Commission, Material Licensing Branch, Washington,
D.C. 20555.
The
input:
following parts of the preprinted application require your
->l. Item 9, page 8. List the instruments that you have available
in your laboratory. The instruments that we require are
described in Item 9 on page 3 of Regulatory Guide 10.8. .
-3f 2 . VItem
i dr 10,
w e page
n 'i W9.> \lic15 % 1 70
Describe /li method
your CPC.-[7of> survey
SG'
i G1m na &M
meter cali-Gw m&k M
bration by completing th'e blank spaces in Section 3. If you
need additional information, refer to Item 10 on page 5 of
Regulatory Guide 10.8.s /J33 -(,g,.g;g;f,, p
v
3. Item 11, page 14. Submit a laboratory diagram that shows the
type, dimensions, position and thickness of shielding that
you.have available. There is a sample diagram in Item 11 on
page 6 of Regulatory Guide 10.8.gq
4. Item 24, _page 3. Indicate the supplier and exchange fre-
quency for your whole body and finger type personnel moni-
toring devicesgkl
S. Item 26, page 3. The hospital administrator should review
the application and sign and date it. Unless your institu-
tion is fee exempt, provide reneeal fee of $150 payable to
the U.S. Nuclear Regulatory Commission. gr)
SEE PAGE 2 FOR SPECIAL INSTRUCTIONS THAT APPLY TO YOUR APPLICATION
. (1)
s
v .,
--
5- c.
,,' 3
C C.
(2)
.
..
.
_
SPECIAL INSTRUCTIONS FOR YOUR APPLICATION ."trm 20
.
..
6. If you wish to 6ontinue using the sealed therapy sour 6es
listed in Group VI of 10 CFR 35.100, you must submit, as an
atta6hment to your appli6at'on, the information requested in
Items 20.a. through 20.f. on page 11 of Regulatory Guide 10.8
(en61osed). Your response to Item 20.e., sour 6e a66ountability,
should in61ude the following: A- 4 ,, j
a.
,Hilal Phyc55(0215 0AE ATeb) '
'
Designate one individual as sour 6e hustodian and'dev'elop 4,W<t4{~
.,
a prosedure to ensure that all sour 6es are ordered,~
- ' PDM"T
A
w re 6eive d , s t o r e d , ,d~i s p e n's~e'd a n d returned to storage after
pgv/ !'Id '- treatment through ihTs Individual.
b. Develop and submit a running inventory form whi6h lists
all sour 6es by nu611de, type (seed, needle, et6.) and number
on hand. Spa 6e should be provided for the-sour 6e
6ustodian to indi6 ate the number in storage, number
hheaked out for treatment, number returned and number
remaining ea6h time a sour 6e is removed for use or 9 9
r e t u rn e d . fL-- -l, Mil 'N :.thu--lG;.wsmO(~tLk IIS. ( 13W4 .' f *
6. Develop and submit spe61fi6 pro 6edures to ensure
6ompliance with 10 CFR 35.14(b)(5)(vii). g p,3e,/hA2dY
~
d. Develop a s6hedule for periodi6 inventories (e.g.,'&afab
mo n thly- aompare the adtual sour 6e 6ount to the running
inventory. gg _.
ep
s
yes
4
. i. .
NRC FORM 313M
U.S NUCLE AR REGULATORY COMMISSION Approved by OM8
APPLICATION FOR MATERIALS LICENSE - MEDICAL [,', ,~, '30.g3
..
~
INSTR UCTlONS - Complete trems 7 mrough 26 of this a aninar>>Iapolocaroon or an apolocaten for renewalof a focense
use supplementalsheets
emhere necessary Item 26 must be cornpleted on allapolocatens and soped Retaon one copy. Submot orogonaland one copy of entore
.
apolocaten to Director. 0ffoce of NucIrar Matersals Safety and Safeguards. U.S Nuclear Regulatory Commossion, washmgton. O C.
20555. Upon approval of this applocation, the apolocant .wilrecrove a Maternets L ocense An NRC Materna4 L ocone is assued m accord-
ance owth the generalrequorements contaunedin Title 10. Code of federal Regulatoons, Part 30. and the L ocenser os subsect to Totte 10.
Code of federal Reputatens. Parts 19. 20 and 35 and to locense fee prowsoon of Totte 10. Code of federal Regulatoons. Part 170 .The
locense tre category shous d be stared m item 26 and the approproate fee enclosed
1.4.
NAME AND M AILING ADDRESS OF APPLICANT (inscrucon,
firm.clinue. physician.etc) INCLUDE ZIP CODE 1.tx STREET ADDRESSIES) AT WHICH R ADIOACTIVE MATERIAL
WILL BE USED (t/different from 1.4) INCLUDE ZIP CODE
Providence Hospital
Radiation Safety Office
3200 Providence Drive, feuch 6foOY
Anchorage, Alaska 99504 795c2
TE LEPHONE NO.: ARE A CODEI 907 i 'M O M!!
2. PERSON TO CONTACT REG ARDING THIS APPLICATION 3. THIS IS AN APPLICATION FOR: (Check appropn' ate stem /
ht't0's et f. , 3dj nipA st O NEW LICENSE
H ffQ pggp tx 0 AMENDMENT TO LICENSE NO.
TE LEPHONE NO.: AAE A CODE IT21 2 "NN
4. INDIVIDUAL USERS (Name individuals who willuse or directly 5.R ADIATION SAFETY OFFICER (RSO)(Name o/ person designated
supervrse use of radooactne material. Complete Supplements A and B
as radiaroon safety offocer. If other than ondivedualuser, complete resu-
for each ondividual.)
me of traonung andesperoence as m Supplement A.) ,
D a t tan r1 L . '.d e d M W y *' **
See Item 8 on page 7 . John _R.-Gloverr Ph. D:
(To designate a new RSO, follow the instructions ,
in Item 8.b. on page 5 of Regulator _y Guide 10.8.
6.a. R ADIOACTIVE MATERIAL FOR MEDICAL USE " ' *W
MAXIMUM MARK MAXIMUM
ITEMS POSSESSION ITEMS
RADIOACTIVE MATE RIAL DESIRED POSSESSION
LIMITS ADDITIONAL ITEMS: D E SI R E D LIMITS
LISTED iN: y.' (In mollicuries) *x" (In millicuroes)
10 CFR 31.11 FOR IN VITRO STUDIES IODINE.131 AS IODIDE FOR TRE ATMENT
N/A og nypearnynololSM
N/A
10 CFR 35.100. SCHEDULE A. GROUP I X AS NEE DE D PHOSPHORUS 32 AS SOLUBLE PHOSPHATE
FOR TREATMENT OF POLYCYTHEMIA N/A
10 CFR 35.100, SCHEDULE A. GROUP 11 VER A.LEUKEMI A AND BONE METASTASES
X AS NEEDED
PHOSPHORUS 32 AS COLLOID AL CHROMIC
PHOSPH ATE FOR INTRACAVITARY TREAT- N/A
10 CF R 35.100. SCHE DU LE A, GR OUP fil X 2000 MENT OF MALIGN ANT EFFUSIONS.
GOLD 198 AS COLLOlO FOR INTRA.
10 CFR 35.100, SCHEDULE A. GR OUP IV " ^ N ^ NAN
IODINE-131 AS IODIDE FOR TRE ATMENT
10 CFR 35.100. SCHEDULE A. GROUP V X AS NEEDED OF THYROID CARCINOMA N/A
XENON 133 AS GAS OR GASIN SALINL FOR
10 CFR 35.100. SCHEDULE A. GF7UP VI X 1000se
BLOOD FLOW STUDIES AND PULMONARY N/A
_
FUNCTION STUDIES
6.b. R ADIOACTIVE MATERI AL FOR USES NOT LlSTED IN ITEM 6.a. Isca,edsounes up to 3mC,usedfor
catobratoon and reference standards are authorized under Section 35.14(d),10 CFR Part 35. and NEED NO T BE LISTEDJ
CHEMICAL MAXIMUM NUMBER
E LEMENT AND MASS NUMBER AND/OR OF MILLICURIES
PHYSICAL FORM DESCRIBE PURPOSE OF USE
OF EACH FORM
Strontium 90 Sealed source 10 Instrument calibration
Cesium 137 Sealed source 100 Ins trument calibration
,
w ..
NEC F ORM 313M
C899
- - ,
. a. .
INFO [ \ TION REQUIRED FOR ITEMS 7 THROU[ 23
Fir items 7 through 23, check the approhlate box (es) and submit a detailed description of'$11 the requested information. Begin
each item on a separate sheet. Identify the item number and the date of the application in the lower right corner of each page. If
you indicate that an appendix to the medical licensing guide will be followed, do not submit the pages, but specify the revhion
number and date of the referenced guide: Regulatory Guide 10.8 7 Rev. Date:
- NOTE: All appendices referenced on this page are based on Regulatory Guide 10.8,
--
Revision 1, and are attached to the application. Some appendic'es have been slightly
modified to reduce the reculatory burden.
t( W W a r> - f c cl/awis
7. MEDICAL ISOTOPES COMMITTEE (Page 5) 15. GENERAL RULES FOR THE SAFE USE OF
RADIOACTIVE MATERIAL / Check One) (Page 18)
x m.~. ,,a e n~.;,,e a . -w . '" App n x Ruta FoHowet or gg
(See Page 5) X
y Duties as in Appendix B;or Equivalent Rules Attached
(Check One)
Equivalent Duties Attached
16. EMERGENCY PROCEDURES (Check One)(Page 19)
c ?! : vu r M u. m .s
-g 8. TRAINING AND EXPERIENCE (Page 7) X Appendix H Procedures Followed;or g
.; , !;-. x : ^ ' " " * 9 d M - E " ' - C 4, . e ' ' ' - - -
Equ,ivalent Procedures Attached
X d- (See Page 7)
Supplement A Attached for RSO. 17. AREA SURVEY PROCEDURES (Check One)(Page 20)
', ,
W ~i Cu r k n s -c n.a n > . i . v :'
(Check Onel (Page 8) ' '
.
9. INSTRUMENTATION
a..,..-
X Appendix I Procedures Followed;or
,..'
-
X Appendix C Form Attached;or Equivalent Procedures Attached
List by Name and Model Number 18. WASTE DISPOSAL (Check One) (Page 21)
'
-0.YAl[lB~ ~~. ION OF ,h t U
Appendix J, Form / ttached;or_,.a ,m,,,
,
m ..~,neua
a a n-o nd; v r1 pen-c a. ..o e r e tsn ..ad we q ~-
X ,,_
Eh * .LI~lind ' & ~I^ ' g
X s.,,,,, o ,... ~ (See Page 9) Equivalent Information Attached g ,g,
u en r edu e's t e a
N19' / Check One) (Page 23)
Appendix D Procedures Followed for Dose
g X '
X
f)1LituC/
Appendix KfPro
socn
ures Foll ed;or
) S1 ~ p2gg
Calibrator;or @T7tR'6> Sld3g pg ,
.
Equivalent ProcNuhebtt(cfb
OICfk Equ a e t ceduIe's' Attached Nie<[
11. FACILITIES AND EQUIPMENT (Page 14) 420. THERAPEUTIC USE OF SEALED SOURCES (Page 27)
f dvr+vrt-itubs L undTr&f ant rmtdr . . . -
> _
- . ~
l MC~ .21C YNOOCW I. SHS'U"ENU' N
{ Description and s.agram
- Ul c/bedh! Attached;andIIA 50 'NHL50 5 ~NLC f0'd
'
X X Detailed information
) be.c ,
' n .e y a u vl + .1r--i e ggyp . In 51 f~-l*7 pf
(
!
' 12. PERSONNEL TRAINING PROGR AM (pa9e 15 } X Appendix Procedures Foklowed;or #D b
>
(Check One) ,%' ',
X Description of Training Attached h (t772n k fC Equivalent Procedures Attached
PROCEDURES FOR ORDERING AND RECEIVTNG PROCEDURES AND PRECAUTIONS FOR USE OF
RADIOACTIVE MATERI AL (Page 16) 21. RADIOACTIVE GASES (e.g., Xenon - 133)
X Detailed Information Attached k Detailed information Attache dc )(e-/33
PROCEDURES FOR SAFELY OPENING PACKAGES
14. CONTAINING RADIOACTIVE MATERIALS 22' RADIOACTIVE MATERIAL IN ANIMALS
(Check One) (Page 17) Detailed Information Attachehc, g',Q MM
PROCEDURES AND PRECAUTIONS FOR USE OF
4X ; Qh Cg,y [ 7 * ' df( 23. RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6.b
,
Equivalent Procedures A'ttached oiNo#n O
l
l & N ss & s, .# h enT cng
.
X
Deta e
afg m i
tt ch
s
I
(Page 31 'f(-
unc so F' """*w'*
\ acu .y asau (caa g g g ,
/
)
Page 2
M f Mikfi9 C Y Cha~ Mhg/dp 4M*Y. /u $57tf a h
1 - w: ,im_ u: . e., ;, .~ Z L en - C i),
. .. ..
24. PE'RSONNE L MONITORING DEVICES
T YPE
SUPPLIE R EXCHANGE FREQUENCY
(Check sopropronte boaI .
"'"
. x R.S. undoeu v- me.
5. WHOLE
"
-
a*v
OTHE R ISpecotyl
Glaumf J/d4
FILM
_
b. FINGER TLD
X g
OTHE R ISpeco1y1 -
FILM
c. WRIST TLD
OT H E R ISpecify)
d. OTHER (Specify/ ALARA PROGRAM _.
This institution is committed to the ALARA program set forth in Appendix 0, attached to
this application beginning on page 33. 29 . . f~
U\-hoc 8M W, .
&ucuta.I;uno>.
25. FOR PRIVATE PRACTICE APPLICANTS ONLY
a HOSPITAL AGREEING TO ACCEPT P ATIENTS CONT AINING R AOIOACTIVE M ATE RI AL
N AME OF HOSPITAL t1 ATTACH A COPY OF THE AGREEMENT LETTER
SIGNED BY THE HOSPITAL ADMINISTRATOR.
M AILING ADDRESS
c. WHEN REQUESTING THER APY PROCEDURES,
ATTACH A COPY OF R ADI ATION SAFETY PRECAU-
CI T Y STATE ZIP CODE TIONS TO BE TAKEN AND LIST AV AIL ABLE
R ADIATION DETECTION INSTRUMENTS.
26. CERTIFICATE
(This item must be completed by applican t)
The applicant and any official enecuting this certelscate on behalf of the appleCant named i9 ltem la certif y that this appleCatson es prepdred en
contoemity with Teile 10. Code of Federal Regu'ations, Paris 30 and 35, and that all enformation contained herein, including any supplements
attachert hereto, es true and correct to the best of our knowledge and beleef.
b APPLICAN T OR CE R TIF YING OF FICI AL (S,pnaturel
a LICENSE FFE REQUIRED
ISee Seetoon 170 31,10 CF R 110) I t > M M E I Type of Proosti
ill LICENSE FEE CATEGORY. m T87LE
g
-"
c. DATE
(2) LICENSE FEE ENCLOSED: S150.00
NRC F oRM 313M 19 811
Paoe 3
._ . - . -- - -.
_ .__
. O. .
..
.
. _ _
,,
RADIATION SAFETY / Medical Isotopes Comittee
The membership of this comittee will consist of at least three members and will
include:
1. the radiation safety officer;
2. the hospital administrator, or other administrative official directly
responsible to the hospital administrator in the hospital's internal
chain of command;
3. a physician * specialis.t from each department where radioactive materials
are used; and
4. a representative of the hospital's nursing staff.
The names and qualifications of the comittee members will be documented in the
committee's records, will be updated as necessary, and will be available for
inspection by the NRC.
r
- Some departments, such as the nuclear pharmacy, may not be under the supervision
of a physician. In these cases, the supervisory paramedical professional will be
a member of the comittee.
s
"'
Item 7
Page 5
. _ , , . _ _ _ _ _ _
. _ . _ _ . _ -. -. _ __
__
. c. .
APPENDlX B
% "
MEDICAL ISOTOPES COMMITTEE' ,
-
--
Responsibility
- - keeping personnel) are properly instructed as required
by 19.12 of 10 CFR Part 19.
The committee is responsible for *
4. Review and approve all requests for use of radioactive
1. Ensuring that allindividuals who work with orin the
material within the institution.
vicinity of radioactive material have sufficient training
and experience to enable them to perform their duties 5. Prescribe special conditions that will be required dur-
safely and in accordance with NRC regulations and
ing a proposed use of radioactive material such as
the conditions of the license.
requirements for bioassays, physical examinations of .
2. users, and special monitoring procedures.
Ensuring th'at all use of radioactive material is con-
ducted in a safe manner and in accordance with NRC 6. Review the entire radiation safety program at least
regulations and the conditions of the license.
annually to determine that all activities are being con-
Duties ducted safely and in accordance with NRC regulations
and the conditions of the license. The review shall
The committee shall:
include an examination of allrecords, reports from the
radiation safety officer, results of NRC inspection,
-'
l. written safety procedures, and the adequacy of the
Be familiar with all pertinent NRC regulations, the institution's management control system.
- terms of the license, and information submitted in sup-
port of the request for thelicense anditsamendments. 7. Recomrnend remedial action to correct any deficiencies
2. identified in the radiation safety program.
Review the training and experience of all individuals
who use radioactive material (including physicians, 8. Maintain written records of all committee meetings,
technologists, physicists, and pharmacists) and deter-
-D mine that their qualifications are sufficient to enable
actions, recommendations, and decisions.
them to perform their duties safely and in accordance 9 Ensure that the byproduct materiallicense isamended,
with NRC regulations and the conditionsof thelicense,
when necessary, prior to any changes in facilities,
3. equipment, policies, procedures, and personnel, as
Establish a program to ensure that allindividuals whcse specified in the license,
duties may require them to work in the vicinity i,f
radioactive material (e.g., nursing, security,and house- Meeting Frequency
The medical isotopes committee shall meet as often as neces-
'A rule is es pected in 1981 Nt would thange the name.composi- sary to conduct its business but not less than once in each
tion.and runctions of this committee.
Calendar quartet.
i
i
l
l
l
t -
I
!
! '%-
l
l
t
- "
Item 7 Cont'd
Page 6
l
>
._ _ .. . -. . - _ _.
. . -
. s. .
NAME OF AUTHORIZED USER * AUTHORIZATION
. ,
- Maurice J. Coyle, M.D. eid I-133 Of Y'"*"" # N'j P'gg. ,js_g' Groups I, II, III and VI
"
--
/ John J. Kottra, M.D.-odd I-/3/A frea tw"N,,
,
'
,,. Groups I, II and III
nappatu,r ww"
-
e
l
Charles Sternhagen, M.D. Groups IV, V and VI
' John-R.-Glover,-PheD:- c2dct? -Non-human-use
Soo-K.-Choi,-M.D.- 6/fL -Groups-IVrV-and-VI-
Peter DeMott Swift, M.D. Group.VI
Y, 'd
$ Denise a:bok , h.D. Neb ck2fEaW ; g,, up , r, x , tt ,12
g cand r, L, Eclimer, 4.s. Men 4m m an asc
-
.
- If you wish to add additional names to the list, follow the instructions in
Item 8 on page 4 of Regulatory Guide 10.8.
$
g. . .
l Item 8
i Page 7 -
!
_ . . ._ . _ . _ _ _ _ _ _ _ . . _ . . _ . _ ._. _ _ _ _ _ _
. .. .
APPENDlX C
INSTRUMENTATION .-
.
-~~
I. Survey meters
..
,
a. Manufacturer's name:
Manufacturer's model number :
.
Number or instruments available :
Minimum range: mR/hr to
.
mR/hr
.
Maximum range mR/hr to mR/hr
b. Manufacturer's name :
Manufacturer's model number:
Number ofinstruments available :
-- -
Minimum range : mR/hr to _ mR/hr
Maximum range: mR/hr to mR/hr
2. Dose calibrator
Manufacturer's name :
Manufacturer's model number :
Number of instruments available:
3. Instruments used for diagnostic procedures
' Manufacturer's
Type of Instrument
Name Model No.
4
Other (e g.. liquid scintillation counter, area monitor. velometer)
.
l
l
l
! t
i Item 9 .
...
l
Page 8
-
_ . _ - . _.
. . _ . , . _ _ _ _ _ _ . _ _ , _ . , - _ . . . _ . . - _ _ . _ _ _ _ . . . _ . _ . . _ . _ _ _ _ . . . _ _ . ,
-
. .
CAllBRATION OF SURVEY INSTRUMENTS
,-
._
Check appropriate items.
.- X l. Survey instruments will be calibrated at least annually and following repair.
, Y 2. Calibration will be performed at :wo points on each scale used for radiation protection purposes,i.e., at least up
to 1 R/hr.
The two points will be approximately 1/3 and 2/3 of full scale. A survey instrument may be considered properly
calibrated when the instrument readings are within 110 percent of the calculated or known values for each point
checked. Readings within 120 percent are considered acceptable if a calibration chart, graph, or response factor
is prepared, attached to the instrument, and used to interpret readings to within 1I0 percent. Also, when higher
scales are not checked or calibrated, an appropriate precautionary note will be posted on the instrument.
3. Survey m.struments wd. l he calibrated 4gdir Mit. (ComG. Cs--67
a. By the snanufacturer *
i&;ffD ",' t/tt/1/ICN- See ( . IS +- R.
V b. At the licensce's facility ' l'wM '
ly,,, G [L 9] ,vr.s s, #.%/ 3 o$. g p),~-
.
'
(1) Calibration source -
Radionuclide Fe ?W'
Manufacturer's name *'in n 9 *- : v' e a
'"
Model no. . ~5 *
6 ud N . / Activity in millicuries 'W' 4.- If4 X MLM tIWh /S 3 3 0 ,n (i - #Af
.- d.1# N . gJ,b.
or
, f Exposure rate at a specified distana # 2 'n N b ** O "-
.g :g.48 g , ': . ~ ' <*A ccu racy ..- ->
3
. .I / t. Traceability to primary standard #'mw '
"'. " i * *"#b' 2 / "cy'
C * * ' ',h,d -Its 1;+tm T,'n, -(.7/Jdygope:f" { * '
,', ,-
(2) The calibration procedures in Section I of Appendix D will be used
or
(3) The step-by-step procedures, including radiation safety procedures, are attached.
Y c. By a consultant or outside firm
l
(I) Name ' 'U I' FMi
'
(2) location 'O I
'8 9 9~. T/5
(3) Procedures and sources
have been approved by NRC and are on file in License No.
'
l have been approved by an Agreement State.a copy of the Agreement State license. the
procedures, and a description of the sources are attached, and the consultant's report will
contain the information on Wa. gjj ,. , .j.,l _ j ,
the attached " Certificate of Instrument Calibration." [
h.
,
"
-7-[ 5^ '
the consultant's reportmg form as attached. f.C^ ,,.N n g-
-
7&% ~
are described in the attachment, and the consultant's report willcontain theinformation on
the attached " Certificate of Instrument Calibration."
the consultant's reporting form as attached,
i
i
.'...
~
I
Item 10
Page 9
- .. .
wg assa6apphk&
, Call 8 RATION OF DOSE CAllBRATOR ,gg d
an%%
..
.
. A. Sources Used for Linearity Test
1 -
(Check as appropriate)
X
First elution from new Mo-99/Tc-99m generator
or
X
If generators are not in use, a source of Tc-99m with
Other*(speciry)_ activity equivalent to the maximum activity assayed to
clinical situations will be used.
B. Sources Used for Instrument Accuracy and Constancy Tests
Suggested
Radionuclide Activity (mci) Activity (mci) Accuracy
Co-57 35 One millicurie or more within i 5%
Ba133
,
-'
O.l.0.5
1
microcuries or more within i 5%
Cs-137 0.I 0.2 100 microcuries or more within i 5%
Ra-226 1-2 N/A N/A
N/A N/A N/A
_-
C. X
The proce'dures described in Section 2 of Appendix D will be used for calibration of the dose calibrator
or
. . Equivalent procedures are attached. ,
'For licensees who are not authorized for Mo-99/Tc 99m generators. activity must he equivalent to the highest activity used.
J
$ -
Item 10 Cont'd "
Page 10
- - - . .-. _ _ . . _ _ _ _ - . . -- _
,--
. *
.. .
APPENDIX D (Continued)
,.
Section 2 .
..
METHODS FOR CALIBRATION OF DOSE CALIBRATOR *
..
All radiopharmaceuticals must he assayed for activity to 3. Calculate net activity of each source subtracting
an accuracy of 10 percent. The most common instrument for out background level.
accomplishing this is an ionization-type dose calibrator. The
instrument must be checked foraccurate operation at the time
of installation and periodically thereafter. 4. For each source. plot net activity versus the day
of the year on semilog graph paper.
A. Test for the following: .
'
5. Log the background levels.
I. Instrument constancy (daily)
2. Instrument accuracy (at installation and annually 6. Indicate the predicted activity of each source
thereafter) based on decay calculations and the +5 percent
limits on the graph.
3. Instrument linearity(at installation and quarterly
thereafter)
7. Repeat the procedure used for the Cs-137 source
4. Geometrical variation (at installation) for all the commonly used radionuclide settings.
B. After repair or adjustment of the dose calibrator, repeat 8. Variations greater than 15 percent from the pre-
all the appropriate tests listed above (dependent upon dicted activity indicate the need for instrument
the nature of the repairs). repair or adjustment.
C.- Test for instrument Constancy 9. Investigate higher than normal background levels
Lo determine their origin and to eliminate them
Instrument constancy means that there is reproduci- if possible by decontamination, relocation. etc.
bility, within a stated acceptable degree of precision,
in measuring a constant activity over time. Assay at
least one relatively long-lived teference source such as D. Inspect the instrument on a quarterlybasis to ascertain
Cs-137, Co-57,** or Ra-226** using a reproducible that the measurement chamber liner is in place and
geometry before each day's use of the instrument. that instrument zero is properly set (see manufacturer's
Preferably, at least two reference sources (for example, instructions).
3 5 mci of Co-57 and 100-200 pCi of Cs-137 or 1-2
mg Ra-226 (with appropriate decay corrections) will
be alternated each day of use to test the instrument's E. Test of Instrument Linearity
performance over a range of photon energies and
source activities. The linearity of a dose calibrator should be ascertained
over the entire range of activities employed. This test
1. Assay each reference source using the a ppropriate will use a vialof Tc-99m whose activity is equivalent to
instrument setting (i.e., Cs-137 setting for Cs-137). the maximum anticipated activity to be assayed (e.g.,
the first elution from a new generator).
2. Measure backgroundlevelat same instrument set-
ting. or check that automatic background sub- 1. Assay the Tc.99m vial in the dose calibrator. and
traction is operating properly when blanks arc subtract background level to obtain net activit)
inserted in the calibrator. in millieuries.
See ANSI N42.131978." Calibration and Usage or Dose Calibratur 2. Repeat step 1 at time intervals of 6. 24. 30. and
tanisation Chamhers ror the Anay or Radeonuclides" (Arnerican 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> after the initial assay.
Natannat Standards institute. Inc 143o Droadway. New York, N.Y.
tools).
~
Ca.s? and Ra-226 are nnt subject to NRC t
siste anney should be consulted to determ ne t r qui e ents mg point, Calculate the predicted aClivities at 0,
gemssang thea material. 6. 24, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> using the following tabic!
Item 10 Cont.'d ..
Page 11
.
_ _ _ _ _ - .
'
. .
.,
as in ster 1. tTollow vond radistwn safety prac-
Assay Tirne* (hr) Correction Factor
lices in avoid ctmtammation and to minimite
radiation exposure.)
0 31.633
6 15.853
f.995 3. Select one volume as a standard (such as the
24 volume of reference standard usedin performmg "
30 I
- the test for instrument accuracy).and calculate
48 0.I26
the ratio of measured activities for each volume
to the reference volume activity.Thisrepresents
Example: If the net activity measured at 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br />
was 15.625 mci, the calculated activities for 6 and
the volume correction f actor (CF).
48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would be 15.625 mci x 15.853 = 247.7 Erampic; If activities of 2.04,2.02, and 2.00 mci
mci and 15.625 mci x 0.126 = 1.97 mci, respec. are measured for 4,8. and 10 mi volumes and
tively, 3 0 mi i5 'h* I*""*' ' I"*' '*I""d-
4. On semi-log corrdinate paper, plot the
measured net activity and the 2.00
= 0.98
calculated activity versus time. 4 ml Volume CF =2.04
5. The activities plotted should be within 15 percent Plot the correction factors against the volurne on
4.
of the calculated activity if the instrument is linear graph paper. Use this graph to select the
linear and functioning properly. Errors greater proper volume correction factors for routine
than 15 percent indicate the need for repair or assay of that radionuclide.
adjustment of the instrument.
5. The true activity of a sample is calculated as
6. If instrument linearity cannot be corrected,it will
follows
be necessary in routine assays to use either(a) an
aliquot of the cluate that can be accurately mea- True Activirv = Measured Activity x
sured or (b) the graph constructed in step 4 to Correction Factor
relate measured activitiesto calculated activities. .
where the correction factor used is for the same
F. Test for Geometrical Variation volume and geometrical configuration as the
sample measured.
s
There may be significant geometricalvariation in activi-
'
ty measured as a function of sample volu me or configu- Similarly, the same activity of Co-57 in a syringe
6.
ration, depending on the volume and size of theioniza- may be compared with that of 10 mIin a 30-cc
tion chamber used in the dose calibrator. The extent vial, and a correction factor may be calculated.
of geometrical variation should be ascertained for
commonly used radionuclides and appropriate correc- It should be noted that differences of '00 percent
7.
tion factors computedif variations are significant,i.e., in dose calibrator readings between glass and
greater than 12 percent. (Even though correction fac- plastic syringes have been observed for lower-
tors may be provided by the manufacturer, the accu- energy radionuclides such as 1 125, which should
racy of these should be checked.)When available from be assayed in a dose calibrator only if the relia-
the manufacturer, certified data on geometrical varia- bility of such an assay can be established. Glass
tions may be used in lieu of these measurements. tubes and syringes may also vary enouFh in thick-
ness to cause significant errors in assaying 1125.
To measure variation with volume of liquid, a 30-cc be
lience, adequate correction factors must
vial containing 2 mci of Co-57 or other appropriate established.
radionuclide in a volume of I ml will be used.
An alternative to providing syrmge cahbration
1. Assay vial at the appropriate instrument setting, factors is to simply assay the stock vial before
and subtract background level to obtain net and af ter filling the syrmge. The activity in the
activity, s) Tinge is then the difference in the two readings
(with a volume correction if significant)
2. Increase the volume of liquid in the vialin steps
to 2,4,8,10,20, and 25 ml by adding the appro- Test for Instrument Accuracy
G.
priate amount of water or saline. After each addi-
tion, gently shake vial to mix contents and assay Check the accurecy of the dose calibrator for several
. radionuclides, including Cs-137. Co-57, and Ba 133.
I
using appropriate reference siandards whose activities
Anay tirnes should be measured in whole hours and correction have been Calibrated by comparisons with standard
herors should he used to the third decimal place as endacated, lhe
snore setent half-lire of T = 6.02 hnuts has been used in calculating sources that have been assaysxi by NBs and documented.
.
these Correction factors.
Item 10 Cont'd -
Page 12
.- , _ - - _ - _ - _
_.
-
. .
The activity levels of the reference sources used should 4. Repeat the. above steps for other commonly used
approximate those levels normally encountered in clin- radionuclides for which adquate reference stand-
ical use (e.g., Co-57,3 5' millicuries) riving adequate ards are availao:e.
attention to source configuration. Identify in your
application the three sources that you will use. State 5. Keep a log of these calibration checks. .-
nuclide, activity, and calibration accuracy. The lower- -
'*^
energy reference standards (Tc-99m Xe-133, I-125) 6. Calibration checks that do r:ot agree within
,
must he in vials with the same thickness of glass as the 15 percent indicate that the instrument should
actualsamples to be measured for best accuracy. be repaired or adjusted. If :his is not possible, a
calibration factor should be calculated for use
during routine assays of radionuclides.'
l. Assay the reference standard in the dose calibra-
tor at the appropnate setting. and subtract the 7. At the same time theinstrumentis beinginitially
background level to obtain the net activity. calibrated at the licensee's facility with the refer-
ence standards, place a long-lived source in the
calibrator, set the instrument, in turn, at the vari-
2. Repeat step I fora totalof 3 determinations,and ous radionuclide settings used (Cs-137,1-131,
average results. Tc-99m,1125, etc.), and record the readings.
These values may later be used to check instru-
ment calibration at each setting (afterconecting
3. The average activitydetermined in step 2 should for decay of the long-lived source) without re-
agree with the certified activity of the reference quiring rnore reference standards. Keep a log of
source within15 percent af ter decay corrections. these initial and subsequent readings.
.
.
Item 10 Cont'd ~
Page 13
-
.. .
9-
.
-
FACILITY DIAGRAM
,, (Prepare and Attach to Application)
Submit a detailed diagram of the facility, indicating the type, dimensions,
position, and thickness of shielding that will be used for:
a. Use and storage of Tc-99m generators.d
q 4,, W,y
%
b.
Storage of radiopharmaceuticals Crefrigerated)and
J nonrefrigerated).
c. ,76howtri, ht:-npoed k;t-
,
Storage
as of radioactive
nonradioactive waste.waste, including de_ cay-in-sto, rage prior to disposal (my"","
(This area should be large enough to handle an
accumulation of used Tc-99m generators as well as other solid waste. If
this area is located outside._yout d.eaartment, describe how the material
will be secured.
p onfirm. -that
- 3,his area
w - will
nos:be surveyed
r+- en, , yat least, weedy--),
d. Preparation and disp nsing of Group III kit radiopharmaceuticals (e.g.,
lead glass L-block).gg
Identify adjacent areas across the walls from use and storage locations, and
show that adequate steps have been taken to ensure that radiation levels-in
unrestricted areas do not exceed the limits specified in paragraph 20.105(b)
of 10 CFR Part 20. c4
.
,
"'
Item 11
Page 14
_ - _ _ ._
-
.. .
(
!
,
!
..
.
--
PERSONNEL TRAINING PROGRAM
..
I. Individuals who work in or frequent restricted areas will be instructed
in the items specified in 10 CFR 19.12 at the time of initial employment
and at least annually thereafter.
This instruction will include:
a. All terms of the license pertinent to radiation safety.
b. Areas where radioactive material is used or stored.
c. Potential hazards associated with radioactive material.
d. Radiological safety procedures appropriate to their respective duties,
e. Pertinent NRC regulations. , ,
--
f. Rules and regulations of the license.
g. Obligation to report unsafe conditions to the radiation safety officer.
h. Appropriate response to emergencies or unsafe conditions.
i. Right to be informed of their radiation exposure and bioassay results.
j. Locations shere the licensee has posted or made available notices, copies
of pertinent regulations, and copies Uf pertinent licenses and license
conditions (including applications and applicable correspondence), as
required by 10 CFR Part 19.
II. Individuals whose duties may require them to work in the vicinity of
licensed material will be informed about radiation hazards and appropriate
precautions at the time of initial employment and at least annually thereafter.
This information will be provided initially at hospital employee orientation
sessions and annually thereafter at in-service meetings.
.
Item 12 d..
Page 15
-- . _ _ _. - - - - . -_
. .
. .
APPENDIX E
..
PROCEDURES FOR ORDERING AND ACCEPTING DELIVERY *
.,
OF RADIOACTIVE MATERIAL
..
The Supervisory Nuclear Medicine Technologist will (1) A written request * will be obtained from the
I.
physician who will perform the procedure.
place all orders for radioactive materials and will ensure
that the requested materials and quantities are auth-
(2) Persons ordering the materials will refer-
orized by the license and that possession limits are not
ence the physician's written request when
ex ceeded.
placing the order. The physician's request
will indicate isotope, compound, activity _
2. A system for ordering and receiving radioactive mate- level. etc.
rials will be established and maintained. The system
will consist minimally of the following. (3) The physician's wTitten request willbe ref-
crenced when receiving, opening,or storing
-
the radioactive material.
a. Ordering of routinely used materials
c. It is essential that written records' be maintained
for all ordering and receipt procedures.
(1) Written records that identify the isotope,
compound, activity levels,.and supplier, 3. During normal working hours, carriers will be instructed
etc., will be used. to deliver radioactive packages directly to the Nuc!ctr
Medicine Department.
4 During off-duty hours, security pc sonr'el or other
(2) The written records will be referenced when
opening or storing radioactive shipment. designated individuals will accept delivery of radioac-
tive packages in accordance with the procedures out-
lined in the sample memorandum below.
In the case of special orders, the physician's wTitten request and
b. Ordering of specially used materials (e.g., thera- appropriate sh i
peutic uses) ,,,,y,o p,3o,,ipP ng/ receipt records will be referenced and the
,,ts adminisiration.
SAMPLE" MEMORANDUM i
MEMORANDUM FOR: Security Perso.nnel .
FROM: Hospital Administrator
SUBJECT: RECEIPT OF PACKAGES CONTAINING RADI0 ACTIVE MATERIAL
Any packages containing radioactive material that arrive between 4:30 p.m. and 7 a.m.
or on Sundays shall be signed for by the Security Guard on duty and taken immediately
to the Nuclear Medicine Department. Unlock the door, place the package on top of the
counter immediately to the right of the door, and relock the door.
If the package is wet or appears to be damaged immediately contact the Radiation
Safety Officer. Ask the carrier to remain until it can be dtermined that neither he
nor the delivery vehicle is contaminated.
- RADI ATION SAFETY OFFICER
- 0FFICE PHONE
- HOME PHONE
- 0n the actual memo that is used, this information will be filled in and updated as
necessary.
Item 13 2. . .
Page 16
L
_ ,
.. .
APPENDIX F
PROCEDURES FOR SAFELY OPENING PACKAGES ,,
CONTAINING RADIOACTIVE MATERIAL .
_ . ,
Special requirements will be followed for packages con-
(2) Open inner package and verify that con-
1.
taining quantities of radioactive material in excess of
tents agree with those on packing slip.
Compare requisition,* packing slip, and
the Type A quantity limits as specified in paragraphs
label on bottle.
2a205(aXI) and (cXI) of 10CFR Part 20 (more than
20 Ci for Mo.99 and Tc-99m). They will be monitored
for surface contamination and external radiation levels
(3) Check integrity of final source container
within 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after receipt if received during working (i.e.. inspect for breakage of seats or vials.
hours or within 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> if received after working loss of liquid. and discoloration of pack-
hours, in accordance with the requirements of para- aging material).
graphs 2a205(a) through (c). All shipments of liquids
greases-thw ==pt-quantities will be tested for leak- (4) Check also that shipment does not exceed
age. The NRC Regional Office will be notified in accord- possession limits.
ance with the regulations if removable contamination
2
exceeds 0.01 pCi/100 cm or if external radiation
levels exceed 200 mR/hr at the package surface or f. Wipe external surface Of fi,nal
10 mR/hr at 3 feet (or 1 m).
source container shield and re-
? move wipe to low background
M 10 mR/hr. stop
(2) If not contaminated, obliterate radiation
procedure and notify Radiatioe Safety Officer.
labels before discarding in regular trash.
d. Measure surface exposure rate and record. If
>200 mR/hr, stop procedure and notify Radiation
3. Maintain records of the results of checkingeach ruckage,
Safety Officer.
using " Radioactive Shipment Receipt Record"(see next
e. Open the package with the following precau- page) or a form containing the same information.
l
tionary steps:
1
(1) Open the outer package (following manu.
facturer's directions, if supplied) and 'In the case or speciat orders (e.s.. therapy dnses). also gnmport
remove packing slip. with physician's written request.
l
!
!
,
"'
i Item 14
l
Page 17
l
!
! - - -- - - - --- . _ _ _ _
-
. .
APPENDIX G
"
GENER AL RULES FOR SAFE USE OF RADIOACTIVE MATERIAL
.
..
Wear laboratory coats or other protective clothing at ity vs. the order written by the physician who will
1.
all times in areas where radioactive materials are used.
perform the procedure.
Wear disposable gloves at all times while handling 7. Wear personnel monitoring devices (film hadgc or TLD)
2.
radioactive materials. at all times while in areas where radioactive matcrials
are used or stored. These devices should be worn at
Monitor hands and clothing for contami.iation after chest or waist level. Personnel monitoring devices when
3.
each procedure or before leaving the area. not being worn to monitor occupational exposures
should be stored in a designated low background seca. ,
,
4 Always use syringe shields for routine preparation of
8. Wear f tD finger badges during elution of generator and
patient doses and administration to patients.except in
circumstances such as pediatric cases when their use preparation, assay, and injection of radiopharmaceuti-
would compromise the patient's well-being. In these cals.
caceptional cases, use other protective methods such
as remote delivery of the dose (e.g., through use of a 9. Dispose of radioactive wute only in specially designated
butterfly valve), and properly shielded receptacles.
5. a. Do not eat, drink, smoke, or apply cosmetics in any 20. Never pipette by mouth. --
area where radioactive material is stored or used,
11. Survey generator. kit preparation, and injection areas
b. Do not store food, drink, or personal effects with for contamination after each procedure or at the end
radioactive material. of the day. Decontaminate if necessary.
6. a. Assay each patient dose in the dose calibrator prior 12. Confine radioactive solutions in covered containers
to administration. Do not use any doses that differ plainly identified andiabeled with name of compound.
from the prescribed dose by more than 10 percent. radionuclide, date, activity, and radiation level, if
a pplicable.
b. For therapeutic doses, also check the patient's name, 13. Always transport radioactive material in shielded
the radionuclide, the chemical form, and the activ- containers.
!
Item 15 2..
Page 18
i
, . _ _ -
-
. .
APPENDIX H
EMERGENCY PROCEDURES ,-
.
.
Minor Spills 3. SHIELD THE SOURCE: If possibic, the spill should
"
be shielded, but only if it can be done without further
I. NOTIFY: Notify persons in the area that a spill has contamination or without significantly increasing
occurred. your radiation exposure.
2. PREVENT TH E SPRE A D : Cover the spill with absorb. 4 CLOSE THE ROOM: Leave the room and lock the
ent paper, door (s) to prevent entry.
3. CLEAN UP: Use disposable gloves and rernote handling 5. CALL FOR HELP: Notify the Radiation Safety Offi-
tongs. Carefully fold the absorbent paper and pad. In- cer immediately,
sert into a plastic bag and dispose of in the radioactive
waste container. Also insert into the plastic bag all other 6. PERSONNEL DECONTAMINATION: Contaminated
contaminated materials such as disposable Floves. clothing should be removed and stored for furit c evalu-
ation by the Radiation Safety Officer. If the spillison -
4. SURVEY: With a low-range, thin-window G-M survey the skia. flush thoroughly and then wash'with mild
meter, check the area around the spill. hands, and soap and lukewarm water.
clothing for contamination.
- RADI ATION SAFETY OFFICER:
5. REPORT: Report inc'ident' to the Radiation Safety MFFICE PHONE:
Officer. *llOME PHONE:
Major Spills * ALTERNATE NAMES ANDTELEPilONE NUMBERS
DESIGNATED BY R ADI ATION S AFETY OFFICER.
I. CLEAR THE AREA: Notify all persons not involved
-
in the spill to vacate the room.
2. PREVENT THE SPRE AD: Ccver the spill with absorb-
ent pads, but do not attempt to clean it up. Confine
the movement of all personnel potentially contami-
nated to prevent the spread.
.
l
l
- 0n the actual copy that is posted in the nuclear medicine department, this information
will be filled in and updated as necessary.
,
, . . .
Item 16
,
Page 19
!
. .
. .
APPENDlX l
AREA SURVEY PROCEDURES
..
.
M'
l. All clution, preparation, and injection areas will be 5. A permanent reccrd will be kept of all survey results.
.. surveyed daily with an appropriately low-range survey including negative results. The record will include:
meter and decontaminated if necessary.'
a. Location. date, and identification of equipment
2. Laboratory areas where only small quantitics of radio- used, including the serial number and pertinent
active material are used (less than 200 pCi) will be counting efficiencies.
surveyed monthly.
b. Name of person conducting the survey.
3. Waste storage areas and all other laboratory areas will
be surveyed weekly. c. Drawing of area surveyed, identifying relevant
< features such as active storage areas. active waste
4. The weekly and monthly surveys will consist of: areas,etc.
d. Measured exposure rates, kend to location on the
a. A measurement of radiation levels with a survey drawing (point out rates that require corrective
meter sufficiently sensitive to detect 0.1 rnR/hr. action).
h. A series of wipe tests to measure contamination c. Detected contamination levels, keyed to loca-
levels. The method for performing wipe tests will . tions on drawing.
be sufficiently sensitive to detect 200 dprn per
100 cm2 for the contaminant involved. Wipes of f. Corrective action taken in the case of contamina-
elution and preparation areas or other "high tion or excessive exposure rates, reduced con.
background" areas will be removed to a low back- tamination levels or exposure rates after correc-
ground area for measurement. tive action, and any appropriate comments,
or dally surveys where no sbnorms! e a posures are found. only the
date the identification of the person performing the survey, and the 6. Area will be cleaned if the contaminationlevelexceeds
survey results vill be recorded. 200 dpm/100 cm2 .
l
l
1
,
I
i
1
!
i
Item 17 ,'..
-
_
Page 20
- .
. .
.
APPENDlX J
WASTE DISPOSAL
..
.
-
Note : In view of the recent problems with shallow-land burial sites used by commercial waste disposal
~
firms, NRC is encouraging its licensees to reduce the volume of wastes sent to these facilities.
Important steps in volume reduction are to segregate radioactive from nonradinactive waste. to
hold short-lived radioactive waste for decay in storage. and to release certain materials in the
sanitary sewer in accordance with 20.303 of 10 CFR Part 20.
l. Liquid waste will be disposed of(check as appropriate) N/A Disposed of by commercial waste disposal serv-
ice (see also item 4 below).
Y . In the sanitary sewer system in accordance with
20.303 of 10 CFR Part 20. N/A other (specify):
-O r-
N/A By com'mercial waste disposal service (see also
item 4 below).
X
'
'" * * * ' * * * ** ""#'
Other (specify): See #3
X IIeld for decay * until radiation levels, as mes-
sured in a low background area with a low-level
survey noter and with all shielding removed. have
2. Mo-99/Tc-99m generators will be(check as appropriate) reached background levels. All radiation labels
will be removed or obliterated, and the waste
X
Returned to the manufacturer for disposal. will be disposed of in normal trash.
-Or- ~
X IIeld for decay * until radiation levels. as mea. N/A Disposed of by commercial waste disposal serv-
sured in a low background area with a low-level ice (see also item 4 below).
survey rneter and with all shielding removed.have
reached background levels. All radiation labels !* Other (specify): D FT'2 rM'r 1--@ ' vd1 -
will be removed or obliterated. and the generators
will be disposed of as normal trash.**
,. gg
- - - -
,j g g, 4p
.
, ,
, 4. The commercial waste disposal service used will be
Be sure that waste storage areas were described in tie ... d
that they are surveyed periodically (Item 17).
N/A
These generators may contain long4ived radioisotopic contami. (Name) (Cit y. Sta te)
sants. Therefore the generator columns mil be segregated so that
they may be monitored separately to ensure decay to hackprnund
levels prior to dispnsat. NRC/ Agreement State License No. ,_N/A
i
l
l
t
item 18 +"
Page 21
.. . ._ - _ _ _ - -
. .
APPENDIX K
RADIATION SAFETY PROCEDURES FOR
(
THERAPEUTIC USE OF RADIOPHARMACEUTICALS*
%.- 1. All putients treatal with I-131 or Au-198 will be placed 8. Nondisposable ite,ms used for these patients will he' held
in a private room that has a toilet.The large surfaces in plastic bagsin the patient's room and willbe checked
in the room and toilet areas that are more likely to be for contamination by the Radiation Safety Officer or
-
contaminated will be covered with absorbent pads or his designec. Items may be returned for normal use.
protective rnaterial as appropriate to the amounts of held for decay, or decontaminated, as appropriate.
contamination to be expected. Attention should be
given to objects likely to be touched by the patient. 9. If urine and vomitus from I-131 therapy patients are
eg.. telephones, doorknobs, and other items that would collected, they will be stored for decay in the radioac-
be difficult to decontaminate. Plastic bags or wrappings tive waste storage area. Such stored wastes will be re-
that are waterproof and e_ ;1y disposable should be tained until they have reached background levels, as
used on the smaller items. measured with alow-levelsurvey meter.They will then
be released to the sanitary sewer system.
2. The putient's room will be properly posted or attended
in accordance with 20.203 or 20.204 of 10 CFR 10. Before a therapy patient's room is reassigned to another
Part 20. patient, the room will be surveyed for contamination
and decontaminated if necessary, and all radioactive
3. Surveys of the patient's room and surrounding areas waste and waste containers will be removed.
will be conducted as soon as practicable after adminis-
tration of the treatment dose. Exposure rates will be 11. Nursing Instructions
measured at the patient's bedside and 3 feet (or I ml
from the patient after administration and at the entrance a. Nurses should spend only that amount of time .,
to the room. The Radiation Safety Officer or his desig- near the patient required for ordinary nursing
nee will then determine howlong a person may remain care. Special restrictions may be noted on the pre-
at these positions and will post these times ~n the caution sheet on the patient's chart. Nurses should
patient's chart and on his door. The results of daily read these restrictions before administering to
surveys will be used to recalculate permitted times, the patients. Call the Nuclear Medicine Depart-
which will be posted on the patient's chart and on his ment or the Radiation Safety Officer with any
door, questions about the care of these patients.
Nursing personnel who atter.d the patient will
4. The form. Nursing Instructions for Patients Treated wear personnel monitoring devices as advised by
with Phosphorus-32, Gold 198, or lodine-131 (or a the Radiation Safety Office.
similar form containing all the requested information),
will be completed immediately after administration of b. Visitors will be limited to those 18 years of age or
the treatment dose. A copy will be posted on the over unless other instructions are noted on the
patient's chart. precaution sheet on the patient's chart.
5. Radiation levelsin unrestricted areas will1 maintained c. Patients must remain in bed while visitors are in
less than the limits specified in paragraph 20.105(b) of the room and visitors should remain at least 3 feet
10 CFR Part 20. (or I m) from the patient.
6. A!!!inens will he surveyed for contamination hefore being d. Patients containing radioactive materials are to be
removed from the patient's room and.if necessary, will confined to their rooms except for specialmedi-
t
be held for decay. cal or nursing purposes approved by the Nuclear
i
Medicine Department.
7. Disposable plates, cups eating utensils, tissue, surgical
attessings, and other similar waste items will be placed e. No nurse, visitor or attendant who is pregnant
in a specially designated cnntainer. The material will be should be permitted in the room of a patient who
collected dai'y by the Radiation Safety Officer or his has received a therapeutic amount of ridioactivity
designee. checked for contamination, and disposed of until the patient no longer presents a radiation
l as normal or radioactive waste, as appropriate. hazard. Female visitors should be asked whether
'
they are pregnant.
- I* * 8P " "
fw sure en submis a compiece response so item 8 9h in addition en
tererenung prncedures an Appendia K. posable plastic gloves when handling urinals,
l
- .'..
l Item 19
Page 23
-
. ,
halpans, emesis basins, cr eth rt co Mers h1ving (3) Disposah[ $tes, cups, end eating utensils
any material obtaind from tir had the putiint. will be uh, by pitients who are tregard
Wash gloves before removing and then wash with l 13I.
hands. The gloves should be left in the patient's
room in the designated waste container These (4) Vomiting within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after oraladmin-
gloves need not be steri!c or surgical in type. istration, urinary inu>ntinence. or encessive
"
sweating within the first 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> may result v
g. Disposable items should be used in the care of in contamina(ion of linen and floor. In any
-
these patients, whenever possible. These items situation where the patient's room may be
should be placed in the designated waste contain-
- contammated or if radioactive urine and/or
cr. Contact the Radiation Safety Officer or his feces is spilled during collection, call the
designee for proper disposal of the contents of Radiation Safety Officer or his designee,
the designated waste container. Ext. . Meanwhile, handle all con-
taminated maternal with disposable gloves
h. All clothes and bed linens used by the patient and avoid spreading contamination,
should be placed in the laundry bag provided and
should be left in the patient's room to be checked (5) Keep all contaminated wastes and vomitus
by the Radiation Safety Officer or his designee. in plastic bags in the patient's roora for
disposal by the Radiation Safety Officer or
i. All nondisposable items should be placed in a his designec. Feces need not be routinely
plastic bag and should be left in the patient's saved unless ordered on the chart. The same
room to be checked by the Radiation Safety toilet should be used by the patient at all
Officer or his designee.
times and it should be well flushof (3 times).
The Radiation Safety Officer will establish
j. Surgical dressings should be changed only as procedures for disposal of wastes (see
directed by the physician. Au 198 leaking from a item 12 below).
puncture wound may stain the dressings dark red
~~
or purple. Such dressings should not be discarded I. If a nurse, attendant, or anyone else knows or
but should be collected in plastic bags and turned suspects that his or her skin or clothing, including
over to the Radiation Safety Officer or his desig- shoes, is contaminated, notify the Radiation
nee. Handle these dressings only with tongs or Safety Officer or his designee immediately. This
tweezers. Wear disposable gloves. person should remain in an area adjacent to the
patient's room and should not walk about the
k. For 1-131 patients: hospital. If the hands become contaminated, wash
them immediately with soap and water. s-
(1) 'lo the degree possible with cooperative
patients, urine will be collected in special m. If a therapy patient should need emergency sur-
containers provided by the Radiation Safety gery or should die, notify the Radiation Safety
Officer or his designee. The patient should Officer or the Nuclear Medicine Department
be encouraged to collect his own urine in immediately.
the container. If the patient is bedridden, a
separate urinal or bed pan should be pro- n. When the patient is discharged, call the Radiation
vided. The urinal or bed pan should be Safety Officer or his designee or the Nuclear Medi-
flushed several times with hot soapy water cine Department and request that the room he sur-
after use. veyed for contamination before remaking the ronnt
(2) If the nurse helps to collect the excreta, 12. Waste Disposal
disposable gloves should be worn. After-
ward, hands should be washed with the When contaminated wastes are transported to the Waste
gloves on and again after the gloves are re- Storage / Disposal area. precautions will be taken to
moved. The gloves should be placed in the minimize external irradiation of personnel. Stored
designated waste container for disposal by wastes will be shielded to maintain exposure to per-
the Radiation Lfety Officer or his designee. sonnelin restricted and unrestricted areas ALAR A.
Item 19
Page 24 y
. . . .
, , ,--. - - - - -
. .
( Date
NURSlNG INSTRUCTIONS FOR PATIENTS TREATED VJITH
PHOSPHORUS 32, GOLD-198 OR IODINE 131
..
., ./
V Patient's Name :
vkoom No.: __ _ Physician's Name:
/ Radioisotope Administered:
!Date and Time of Administration:
vDose Received: Method of Administration:
_ Exposure Rates in mR/hr
t 10 feet from bed
Date ,
/d 1fm Md 3 fee't from bed
_
(Comply with all checked items)
1. Visiting time permitted: M *IN '
2. Visitors must remain from patient. /
3. Patient may not leave room. !
(, 4. Visitors under 18 are not permitted./
5. Pregnant visitors are not permitted.!
,M -6. Film or TLD badges must be worn.a kifdOTC5 PER PERsev , Pet SAH=T p,/7/2
7. Pocket chambers will he worn for supplementary personnel monitoring ofindividual tasks.
8. Tag the following objects and fill out the tag:
door chart
hed . wdst
-9 Disposable gloves must be worn while attending patient.
10. Patient must use disposable utensds. /
11. All items inust remain in room until approved for moval by the Radiation Safety Officer or his designee.
I 2. Smoking is not permitted.
.13. Room is not to be released to Admitting Office until approved by the Radiation Safety Officer or his designee.
14. Other instructions.
In case of an emergency contact:
Name On-duty /Off. duty Telephone Numbers
%
Item 19 '
'"
Page 25
-__ - . - _ - _ , . _ _ _ _ _ _ - - _
.
-
. ..
-
,S
RADIATION SAFETY PROCEDURES FOR IODINE 131 THERAPY .-
wr g
"
Volatile iodine is released from therapeutic liquid iodine 131 solu-
tions. Opening and preparing these solutions The for patient administration
following procedures
can cause an airborn radioactivity hazard.
in order to prevent contamination and thyroid uptake in
will be' observed prepare and administer therapeutic quantities of iodine
individuals who -
131:
A. Therapeutic doses of iodine 131 will be received, possessed and used
only in capsule form, cg-
B.
If therapeutic doses of iodine 131 .are ordered for use in liquid
form, personnel will be instructed as follows:
(1) Conduc't procedures that involve opening and preparing
therapeutic liquid iodine 131 solutions in a fume hood with
adequate airflow. _.
,
(2) Wear waterproof disposable gloves when opening and preparing
iodine 131 solutions.
(3) Have your thyroid checked for the presence of iodine 131
approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after opening Use theorthyroid
preparing
uptake therapeutic
equip-
liquid iodine 131 solutions.
ment for this check. Report any counts above background
level to the radiation safety officer immediately.
,
Item 19 .
We=
P49e 26
- _ - _ . . - . . _ . . . _ . -. ._. _ _- .
.- ..
.
., ,
e. r ( APPENDIX L
R ADI ATION SAFETY PROCEDURES FOR
THER APEUTIC USE OF SEALED SOURCES *
%. l. All patients treated with brachytherapy sources will be be contacted to answer any questions about the
placed in a private room that has a toilet.
"" care of these patientsin regard to radiation safety
precautions.
,,
2. The patient's room will be properly posted or attended in
accordance with 20.203 or 20.204 of 10 CFR Part 20. b. Nurses should spend only the minimum time
necessary near a patient for routine nursing carr
3. Surveys of the patient's room and surrounding areas Obtain and wear a film or TLD badge or a pocket
will be conducted as soon as practicable after sources
chamber as instructed by the Radiation Safety
are implanted. Exposure rate measurements will be Officer.
taken at 3 feet (or I m) from the patient with sources
implanted, at the patient's bedside, at 3 feet (or I m) c. When a nurse is assigned to a therapy patient, a
from the bed, and at the entrance to the room. The film or TLD badge should be obtained immedi- .
Radiation Safety Officer or his designee will then deter- ately from the Radiation Safety Officer or his
mine how long a person may remain at these positions designee. The badge shall be worn only by the
and will post these times and the exposure rate at 3 feet
nurse to whom it is issued and shall not be ex-
(or I m) from the patient on the patient's chart. changed among nurses.
4. Immediately after sources are implanted, the form d. Pregnant nurses should not be assigned to the
" Nursing Instructions for Patients Treated with Brachy- personal care of these patients.
therapy Sources will be completed and attached to
the patient's chart. c. Never touch needles, capsules, or containers hold-
ing brachytherapy sources. If a source becomes
5. Radiation levels in unrestricted areas will be maintained dislodged, use long forceps and put it in the
less than the limits specified in paragraphs 20.105(bXI)
corner of the room orin the shielded container
and (bX2) of 10 CFR Part 20. provided; contact Radiation Therapy, the Radia-
tion Safety Officer, or the Nuclear Medicine
6. Nurses caring for brachytherapy patients will be assigned Department at once.
film or TLD badges. TLD finger badges will also be
b'
assigned to nurses who must provide cx tended personal f. Bed hath given by the nurse should be omitted
care to the patient. Pocket dosimeters may be assigned while the sources are in place.
In addition to a film or TLD badge.
g. Perineal care is not given during gynecologic
7. At the conclusion of treatment, a survey will be per- treatment; the perineal pod may be changed when
formed in accordance with paragraph 35.14(bX5 Xvii) necessary unless orders to the contrary have been
of 10 CFR Part 35 to ensure that all sources other than written,
permanent implants have been removed from the patient
and that no sources remain in the patient's room or in h. Surgical dressings and bandages used to cover the
any other area occupied by the patient. At the same area of needle insertion may be changed only by
time. all radiation signs will be removed and all film the attending g iysician or radiologist and MAY
and TLD hadges assigned to nurses will be collected. If NOT BE DISC / 'tDED until directed by the radi-
the patient is to be discharged, the final survey will ologist. Dressings should be kept in a basin until
also include a notation on the patient's chart that the checked by the Radiation Safety Officer or his
activity remaining in the patient meets conditions for designee.
release from the hospital.
8.
Special orders will be written for oral hygiene for
Instructions to Nurses patients with oralimplants.
a.
Special restrictions may be noted on the precau- 6. No special precautions are needed for sputum,
tion sheet on the patient's chart. Nurses shoul.1
urine, vomitus, stools, dishes, instruments, or
read these instructions before administering in utensils unless specifically ordered, but these
the patient. The Radiation Safety Officer should
= items should be saved for a check with a radia-
ne sure io submie complete responses to trerns 20. ther ush 2orin tion survey meter to ensure that no sources have
a addition to referencing procedures en Appendia t..
been inadvertently displaced into them.
.(
(
,
'"
Item 20
Page 27
-
-
, .
. f. All bed linens must be checke th a radiitiin o. Timergency dures
survey meter befste being removed from the
patient's room to ensure that no dislodged sources (l) If an implanted source becomes loose or
are inadvertently removed. separated from the patieni, or
(2) If the patient dies, or ,,
k. These patients must stay in bed unless orders to .
"
the contrary are written. In any event, patients (3) If the patient requires emergency surgery.
will remain in their assigned rooms during the immediately call
treatment period.
Telephone No. (days)
1. Visitors will be limited to those 18 years of age or
,
over unless other instructions are noted on the
precaution sheet on the patient's chart.
p. At the conclusion of treatment, call the Radiation
m. Visitors should sit at least 3 feet (or 1 m) from Safety Officer to(l) survey the patient and room.
the patient and should remain nolonger than the (2) count the radiation sources to be sure that all .
time specified on the form posted on the patient's temporary implants have been removed prior to
door and on his chart. discharging the patient, and (3) record a summary
of the final survey results on the patient's chart.
n. No nurse, visitor, or attendant who is pregnant if any permanent implants are to remain in the
should bepermittedin the room of a patientwhile patient, the Radiation Safety Officer will brief
brachytherapy sources are implanted in the pa- the patient on precautions for minimiting radia-
tient. Female visitors should be asked whether tion exposure to others after discharge from the
they are pregnant. hospital.
..
.
,
a
v
s
Item 20 v.-
Page 28
-_ - _ - - . _ . --. . - . _ _ . _ . -
._ _ . -- . - _ _ _ _ . - - - _ _ _ - _ _ _ _ _ _
.
. .
'
C C l
NURSING INSTRUCTIONS FOR PATIENTS TREATED
I
WITH BRACHYTHERAPY SOURCES
l
- -
,
- Patient's Name:
Room Number: Physician's Name:
.
Isotope and Activity *
Date and Time of Administration :
Date and Time Sources Are To Be Removed : Isotope:
Exposure Rates in mR/hr
Bedside 3 feet from bed 10 feet from bed
.. .
(Comply with all checked items.)
1. Wear film or TLD badge.
2. Wear pocket chambers for supplementary personnel monitoring of individual tasks.
3. Wear rubber gloves.
% .-
4 Tag the following objects and fill out the tag:
door chart
bed wrist
5. Place laundry in linen bag and save.
_ 6. Housekeeping may not enter the room.
i
'
7 Visiting time permitted:
8. Visitors must remain from patient.
__
9. Patient may not leave the room.
10. Patient may not have visitors.
11. Patient may not have pregnant visitors.
12. Patient may not have visitors under 18 years of age.
13. Patient must have a private room.
14. A dismissal survey must be performed before the patient is discharged.
.
L
,
Item 20 +--
Page 29
. ._ - _. _ _ . - _ _ _ - _ _ . . _ _ _ . - . . - .
. .
.,
' f
15. All it;ma mist renni .... the room pntil approved f;r disposal by thk...adittion Safety Officer or his
designee.
16. Contact the Radiation Safety Offlee when temporary sources (nonpermanent implants) are removed to
~
perform a survey to be sure all sources are removed from the patient, to do a physical source count. and to
-
be sure no sources remain in the room.
d
.
17. Contact the Radiation Safety Office when the patient is discharged to survey the room prior to its assign-
.
ment to another patient.
I 8. Other instructions.
Name On duty /Off-duty Telephone Numbers
i
v
e
w
t
+--
Item 20
Page 30
, - - - _
-
. o.
.
( (
-
,.,_ PROCEDURES AND PRECAUTIONS FOR USE OF C$SIUM 137
IN INSTRUMENT CALIBRATORS
The 6esium 137 instrument 6alibration sourde will be possessed an'd-used
in ahEordan&e with pro 6edures submitted by this institution in letter
dated September 15, 1980.
,
at e
Item 23
Page 31
i
Wo.
.
'
. o
APPENOlX 0
MODEL PROGR AM FOR MAINTAINING OCCUPATIONAL RADIATION EXPOSURES
-
AT MEDICAL INSTITUTIONS ALARA "
.
"
(Licensee's N me)
(Date)
1. Management Commitment 2. Radiation Safety Committee (RSC)I
a. We, the management of this (medical facility, a. Review of Propowd Users and Uses
hospital, cre.), are committed to the program
described in this paper for keeping exposures (1) The RSC will thoroughly review the
(individual and collective) as low as is reasonably tiualifications of each applicant with
achievable (ALARA). In accord with thn com- respect to the types and quantities of
mitment, we hereby describe an administrative materials and uses for which he has
organization for radiation safety anJ will develop applied to ensure that the uppheant will
the necessary written policy procedures, and be able to take appropriate measures to
instructions to foster the ALAR A concept with- maintain exposure ALAR A.
in our institution. The organization willinclude
a Radiation Safety Committee (RSC)' and a (2) When considering a new use of hyproduct
Radiation Safety Officer (RSO). material, the RSC will review the efforts
of the applicant to maintain exposure
h. We will perform a formal annual review of the AIARA. The user should have systematized
radiation safety program, including ALAR A procedures to ensure ALAR A and shall
considerations. This shall include reviews of have incorporated the use of special
operating procedures and past exposure records, equipment such as syrmge shields. rubber
inspections, etc., and consultations with the gloves, etc., in his proposed use.
radiation protection staff or outside consultants.
c.
(3) The RSC will ensure that the user Justifies
Modification to operating and maintenance pro- his procedures and that dose will be ALARA
cedures and to equipment and facilitics will bc (individual and collectivet
made where they wdl reduce exposures un! css
the cost, in our judgment, is considered to be h. Delegation of Authority
unjustified. We will be able to demonstrate, if
necessary, that improvements have been sought, (The judicious delegation of RSC authority is
thal modifications have tren conudered.and that essential to the enforcement of an ALARA
they have been implemented where reasonable. program.)
Where modifications have been recommended
but not implemented, we will be prepared to (1) The RSC will delegate authority to the
describe the reasons for not implementing them.
RSO for enforcement of the ALAR A
concept.
d. In addition to maintaining doses to individuals
as far below the limits as is reasonably achievable. (2) The RSC will support the RSO in those
!
'
the sum of the doses received by all exposed imtances where it is necessary for the R50
individuals will also be maintained at the lowest to assert his/her authority. Where the
practicable level. It would not he desirable, for
RSO has been overruled. the Comnutlee
example, to hold thcliighest doses toimlividuals
will record the basis for its action m the
to some fraction of the applicahic limit if this minutes of the Comnutteci sluarterly
involved exposing additional people and si,cnif- meetmg.
icantly increatmg the sum of radiation dmes
tercived by allinvolved individuals.
!
y I
Prevate pres tice ph)tician licenses do not insludC Jn USf. The HSO on private practne physnian lisenses wist auume the
re3pengehehleet ur the R$( undfr bettgHR I.
%
l 5
...
l Item 24
'
Puge 33
i
- *
. e
c. Renew ef ALAR A Prop (2) T So willusure that authirized users.
'
worners. cad are llary personnel who may
(1) The RSC will encourage all users to review be exposed to radiation will be instructed
current procedures and develop new pro- in the ALARA philosophy and informed
cedures as appropriate to impleinent the that management, the RSC, and the RSO
ALARA concept. are committed to implementing the
ALARA concept. '
(2) The RSC will perform a quarterly review
of occupational radiation exposure with c. Cooperative Efforts for Development of ALARA
= particular attention to instances where Procedures
Investigational Levels in Table 0-1 below
are exceeded. The principal purpose of Radiation workers will be given opportunities
this review is to assess trends in occupa- to participate in formulation of the procedures
tional exposure as anindex of the ALARA that they will be required to follow.
program quality and to decide if action is
warranted when Investigational Levels are (1) The RSO will be in close contact with all
exceeded (see Section 6).3 users and workers in order to develop
ALARA procedures for working with
(3) The RSC will evaluate our institution's radioactive materials.
overall efforts for maintaining exposures
ALARA on an annual basis. This review (2) The RSO will establish procedures for
willinclude the effortsof the RSO, autho- receiving and evaluating the suggestions of
rized users, and workers as well as those individual workers for improving health
of management. physics practices and will encourage the
>
use of those procedures.
3. Radiation Safety Officer (RSO)
--
d. Reviewing Instances of Deviation from Good
a. Annual and Quarterly Review ALARA Practices
(1) Annual review of the radiation safety pro- The RSO will investigate all known instances
gram. The RSO will perform an annual re- of deviation from good ALAR A practices and,
view of the radiation safety program for if possible, will determine the causes. When the
adherence to ALARA concepts. Reviews cause is known, the RSO will require changes
of specific procedures may be conducted in the program to maintain exposures AL ARA.
'
on a more frequent basis.
4 Authorized Users
(2) Quarterly review of occupational expo-
sures. The RSO will review at least quar- a. New Procedures involving Potential Radiation
terly the external radiation exposures of Exposures
authorized users and workers to determine
that their exposures are ALARA in accord- (1) The authorized user will consult with,and
anee with the provisions of Section 6 of receive the approval of, the RSO and/or
this program. RSC during the planning stage before using
radioactive materials for a new procedure.
(3) Quarterly review of records of radiation
level surveys. The RSO will review radia- (2) The authorized user willevaluate all proce-
tion levels in unrestricted and restricted dures before using radioactive materials
areas to determine that they were at to ensure that exposures will be kept
A LA R A levels during the previous quarter. ALAR A. This may be enhanced through
h. Education Responsibilities for ALARA Program
b. Responsibility of Authorized User to Persons
(Il The RSO will schedule briefings and educa- Under llis/Her Supervision
tional sessions to inform workers of
ALAR A program efforts. (1) The authorized user will explain the
ALARA concept and his/her comrnitment
to maintain exposures AIARA to all per-
3 "
The NRC has emphasised that the Investigational Levels in this
program see not new dose limits but as noted in ICRP Heport 26.
"R""***a.d88iaa' ut as
Pr ot es tion,. serve thecheck
Internstannal Comrmsion
pnints above which theun Radsolosical
results are son-
(2) The authorized user will ensure that per-
tedered sufricientir emportant in justert further investepations. sons under his/her supervision who are
t
v..
Item 24 Cont'd
- *
. ,
sub):ct to occu[onal radi; tion expo- a. Qurt exposurz of individuils to leu than
sure are trainidA .id educal;d it good inns .ti:nal Levil I.
health physics practices and in maintaining
exposures ALARA. Except when deemed appropriate by the RSO.
no further action will be taken in those cases
where an individual's exposure is less than
g 5. I%rsons who Receive Occupational Radiation Exposure Table 0-1 values for the Investigational LcEel I.
a. The worker will be instructed in the ALARA b. Personnel exposures equal to or greater than
, concept and its relationship to working proce. Investigational Level 1, but less than investiga-
dures and work conditions. tional Level ll.
b. The worker will know what recourses are avail- The RSO will review the exposure of each inde-
able if he/she feels that ALARA is not being vidual whose quarterly ex posures equal or enceed
promoted on the job. Investigational Levell and will report the results
of the reviews at the first RSC meeting following
6. Establishment of Investigational Levels in Order to the quarter when the exposure was recorded. If
Monitor Individual Occupational External Radiation the exposure does not equal or exceed Inve'tiga-
Exposures tional Level 11, no action related specifically to
the exposure is required unless deemed appro.
This institution (or private practice)hereby establishes priate by the Committee. The Committee will.
Investigational Levels for occupational external radia- however, consider each such exposure in com-
tion exposure which, when exceeded, will initiate parir 'a with those of others performing similar
review or investigation by the RSC and/or the RSO. tasks a. in index of ALARA program quality
The Investigational Levels that we have adopted arc and will record the review in the Committee
listed in Table O-I below. These levels apply to the minutes.
exposure of individual workers. ..
c. Exposure equal to or greater than Investiga-
tional Level 11.
Table 0-I
The RSO willinvestigate in a timely manner the
/nvestigationallevels cause(s)of allpersonnelexposuresequalingor en.
/mrems per calendar quarter) ceeding investigational Level 11 and,if warranted,
will take action. A report of the investigation, ac-
% / evell Leiel // tions taken,if any,and a copy of the individual's
Form NRC 5 or its equivalent will be presented
I. Whole body; head and 125 375 to the RSC at the first RSC meetmg following
trunk ; active blood forming completion of the investigation. The details of
organs; lens of eyes; or these reports will be remrded in the RSC minutes.
gonads Committee , minutes will be sent to the manage-
ment of this institution for review. The minutes.
2. Hands and forearms; feet 1875 5625 containing details of the investigation, will be
and ankles made available to NRC inspectors for review at
j the time of the next inspection.
i 3. Skin of whole body * 750 2250
-
d. Reestablishment of an individual occupational
worker's investigational Leveill to a levelabove
Not norrnally applicable to nuclear enedicine operations encept " * *
those using signiricant quantities or betaernetting isotopes.
In cases where a worker's or a group of workers'
exposures need to exceed Investigational Level II.
a new, higher Investigational Level 11 may be
The Radiation Safety Officer will review and record established on the basis that it is consistent with
on Form NRC 5, " Current Occupational External goed ALAR A practices for that individual or
Radiation Faposures," or an equivalent form (e g., group. Justification for a new investigational
- dosimeter processor's report), results of personnel Level 11 will be documented.
l monitoring not less than once in any calendar quarter
f
as required by @ 20 401 of 10 CFR Part 20. The follow- The RSC will review the sustification for, and will
ing actions will be taken at the Investigational Levels approve, all revisions of Investigational Level ll,
as stated in Table 01 : In such cases. when the exposure equals orenceeds
s
Item 24 Cont'd -
l
'
- - - ._- - - - _ - _ _ _ _ . _ _ _ - _ - - - - ,- _- -
- * .
.
N)
the newly established :stigati:nal LevilII,
those rctions listed in ptragraph 6.c abovs will Signature
be followed.
7. Signsture of Certifying Official * Name (print or type)
"
I hereby certify that this institution (or private prac- .
tice) has implemented the ALAR A Program set forth Title
above.
Institution (or Private Practice) Name and Address;
"The per' son who is authorised to make commitments for the
dministration of the institution (e g., hospital administrator) or,
a the case of a private practice, the licensed physician.
.
..
s
.
.
s
t
Item 24 Cont'd---
-
_.- -- .
_