ML20211K956
| ML20211K956 | |
| Person / Time | |
|---|---|
| Site: | 03020372 |
| Issue date: | 08/26/1999 |
| From: | Whitten J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| References | |
| 467328, 50-23214-01, NUDOCS 9909080114 | |
| Download: ML20211K956 (14) | |
See also: IR 05000232/2014001
Text
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NRC FORM 374 PAGE 1 OF 2 PAGES
U.s. NUCLEAR REGULATORY Commission
MATERIALS LICENSE Amendment No.11
Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code
of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations
h:retofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct,
source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to
delivsr or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license
shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all
applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified
below.
Licensee in accordance with letter dated
May 13,1999
1. Healthsouth Diagnostic Centers 3. License number 50-23214-01 is amended in
of Anchorage, LTD. r its entirety to read as follows:
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2. 4003 Lake Otis Parkway, #101
b , ~ .~ Ex'pithtion date September 30,2004
4
Anchorage, Alaska 99508 s C1 5. Docket No.-030-20372
Reference No. s
6. Byproduct, source, and/or special,_ 7. Chemical and/or physical form 8/1 Maximum amount that licensee may
nuclear material '- ..
f- ' possess at any one time under this
4'j / license
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A. Any byproduct material (A.'Any radiopharmaceuticaf ACAs needed l
identified in 10 CFR 35.100 t : identified in f 0 CFR 35.100 n
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B. Any byproduct material 'B. Any radiopharmaceutical .
B J As needed
identified in 10 CFR 35.200 ; .. s
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identified in 10 n CFR'35.200
Ma d4 (% . oi O'
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C. Any byproduct mate at; B
W,~ 200 millicuries
identified in 10 CFR 35:300 Q@B6iidentified o Any inradiopharm,aceutica19
10 CFft35,300
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Medical use described in 10 CFR 35.100. 'N
A.
8. Medical use described in 10 CFR 35.200.
C. Medical use described in 10 CFR 35.300.
CONDITIONS
10. Licensed material shall be used only at the licensee's facilities located at 4003 Lake Otis Parkway, #101,
Anchorage, Alaska.
11. The Radiation Safety Officer for this license is John J. McCormick, M.D. b
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9909080114 990826
PDR ADOCK 03020372
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OFRCIAL RECORD COPY
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NR FORM 374A u.s. NUCLEAR RE uLAToRY Co0lMissioN PAGE 2 of 2 PAGES
Licens) Numtar
50-23214-01
D eket r Reference Number
MATERIALS LICENSE
SUPPLEMENTARY SHEET
030-20372
Amendment No.11
12. Licensed material listed in item 6 above is only authorized for use by, or under the supervision of, the
following individuals for the materials and uses indicated:
Authorized Users Material and Use
Harold F. Cable, M.D. 10 CFR 35.100
[S H E n , .,35.200, and iodine-131
George H. Ladyman, M.D. 10 CFR 35:100,,35.200, and 35.300
sO %.7 s
James L. Faries, M.D. 10 CFR 35.100,35.200, and 35.300
+V 0
John J. McCormick, M.Dg 10 CFR 35.100,35.200 afd lodine-131
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13. The licensee is authorized to transport licensed material only'Jn accordance with the provisions of 10 CFR
Part 71," Packaging aridTranspo'rtationfof 8adioactive Maferlal.",? O
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14. Except as specifically'provided }( fl'othstwise'i
'L )[ f this'licenlse,9 th'e licensee shall
accordance with the statements /represen d
' 7iiid prode' uries contained in the documents, including
any enclosures, listed below, exbapt for minor changes in the rgsdic'a l use radiation safety procedures as
provided in 10 CFR 35.3J. The' Nuclea
statements, representations, and
dures'in theproce;r Regulatorycorrespondence
licensee's applicationfa,nd _Commfssion'siegulat
are more
ons.
restrictive than the regulay% L * g%bQ g.{$ NQ
A.
B.
Letter dated July 29,1994
Letter dated August 11,199 3
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C. Application dated August 1,1994S Jr
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D. Letter dated August 15,1994 '
E. Letter dated April 8,1997
F. Letter received May 15,1997
G. Letter dated May 21,1997
H. Letter dated May 13,1999
1. Facsimile dated August 25,1999
FOR THE U.S. NUCLEAR REGULATORY COMMISSION
IOriginal Signed By
Date AUG 2 6 1999 By
Jack E. Whitten, Senior Health Physicist
Nuclear Materials Licensing Branch
Region IV
Arlington, Texas 76011
'
UNITED STAT 8s
y g*** "%,\ NUCLEAR REGULATORY COMMISSION
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REGION IV l
$11 RYAN PLAZA DRIVE, sulTE 400
g' ARLINGTON, TEXAS 76011-8064
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August 26,1999
Healthsouth Diagnostic Centers
of Anchorage, LTD.
ATTN: John J. McCormick, M.D.
Radiation Safety Officer
'
4003 Lake Otis Parkway, #101
Anchorage, Alaska 99508
SUBJECT: LICENSE AMENDMENT
Please find enclosed License No. 50-23214-01. You should review this license carefully and be
sure that you understand all conditions. If you have any questions, you may contact the
reviewer who signed your license at (817) 860-8197.
,
NRC expects licensees to conduct their programs with meticulous attention to detail and a high
. standard of compliance. Because of the serious consequences to employees and the public
which can result from failure to comply with NRC requirements, you must conduct your program
involving radioactive materials in accordance with the conditions of your NRC license,
representations made in your license application, and NRC regulations. In particular, note that
you must:
1. . Operate in accordance with NRC regulations 10 CFR Part 19, " Notices, instructions and
Reports to Workers: Inspection and investigations," 10 CFR Part 20, " Standards for
Protection Against Radiation," and other applicable regulations.
2. Possess radioactive material only in the quantity and form indicated in your license.
3. Use radioactive material only for the purpose (s) indicated in your license.
4. Notify NRC in writing of any change in mailing address (no fee required if the location of
radioactive material remains the same).
5. Request and obtain written NRC consent before transferring your license or any right
thereunder, either voluntarily or involuntarily, directly or indirectly, through transfer of
control of your license to any person or entity. A transfer of control of your license
includes not only a total change of ownership, but also a change in the controlling
interest in your company whether it is a corporation, partnership, or other entity. In
addition, appropriate license amendments must be requested and obtained for any other
. planned changes in your facility or program that are contrary to your license or contrary
to representations made in your license application, as well as supplemental
correspondence thereto, which are incorporated into your license. A license fee may be
charged for the amendments if you are not in a fee-exempt category.
6. Maintain in a single document decommissioning records that have been certified for
completeness and accuracy listing all the following items applicable to the license:
_ _ _ _ _
'
-& '
H2tithrouth Di: gnostic Cent:rs -2- .
of Anchorage, LTD.
- Onsite areas designated or formerly designated as restricted areas as defined in
10 CFR,20.3(a)(14) or 20.1003.
- Onsite areas, other than restricted areas, where radioactive materials in
quantities greater than amounts listed in Appendix C to 10 CFR 20.1001-20.2401
have been used, possessed, or stored.
- Onsite areas, other than restricted areas, where spills or other unusual
occurrences involving the spread of contamination in and around the facility,
equipment, or site have occurred that required reporting pursuant to 10 CFR
30.50(b)(1) or (b)(4), including areas where subsequent cleanup procedures
have removed the contamination.
1
- Specific locations and radionuclide contents of previous and current burial areas i
within the site, excluding radioactive material with half-lives of 10 days or less, j
depleted uranium used only for shielding or as penetrators in unused munitions, ;
or sealed sources authorized for use at temporary job sites. ,
I
- Location and description of all contaminated equipment involved in licensed l
operations that is to remain onsite after license termination. I
7. Submit a complete renewal application, or termination request at least 30 days before
the expiration date on your license. You will receive a reminder notice approximately
90 days before the expiration date. Possession of radioactive material after your license
expires is a violation of NRC regulations.
8. Request termination of your license if you plan to permanently discontinue activities
involving radioactive material.
You will be periodically inspected by NRC. Failure to conduct your program in accordance with
NRC regulations, license conditions, and representations made in your license application and
supplemental correspondence with NRC will result in enforcement action against you. This
could include issuance of a notice of violation; imposition of a civil penalty; or an order
suspending, modifying, or revoking your license as specified in the " General Statement of
Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG 1600,
Rev.1. ,
,
Thank you for your cooperation.
1
Sincerely,
.
Original Signed By
Jackk.NiN"
Senior Health Physicist. !
Nuclear Materials Licensing Branch l
Dociet: 030-20372
License: 50-23214-01
Control: 467328
Enclosures: As stated
C '
Heilthsouth Diagnostic Centers .-3- .
of Anchorage, LTD.
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DOCUMENT NAME: P:\LTR\ COVER \Healthsouth Diagnostic Centers.wpd
To receid c of document, Indicato in box: "C" = Copy without enclosures "E" = Copy with enclosures "N" = No copy
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'JhWhitt n
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Q OFFICIAL RECORD COPY
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HERLMSOUM
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Diagnostc Centerof Anchorage
M G 2 5 7999
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August 25, 1999
TO: Jack E. Whitten (-AX l-?(7- 660 -3 2./o3
NBC
FROM: Tom Scott
Nuclear Medicine, Health 80uth
Per our conversation on 8/5/99, here is the additional information
you requested regarding our amendment request. If I can be of any
further assistance, please call me at (907) 563-3493.
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3 ppmS To Fotww
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4003 Lake Otis Pkny., Suite 101 * Anchorage, AK 99508 Clinic 907 563-3493 = Fa.t 907 561-2596
e :m 42 No.;;43 p. 2 ]
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Diagnostic Centerof Anchorage
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5
PROCEDURE FOR l 131 THERAPIES OVER 33 MILLICURIES
1.10 CFR 35.75 allows en authorized user to to increase the activity of I-131 for
thorspeut!c administrations from 30 mci to 33 mCl or allow an increase in i
exposure levels from the dosed patlent from 5 mrem /hr to 7 mrm/hr at one
metnr without needing to hospitalize the patient.
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2. For I 131 therapies greater than 33 mCl, both hyperthyroid and thyroid
carcinoma, Reg. Guide 8.39 will be followed. Only thersples that meet the release
critria in 8.39 for a patient to be treated on an out patient bases will be done et this !
facility.
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3. All potential therapy patlants will first be Interviewed' making sure they
understand and will follow the specific radiation safety Iristructions.
4. All patients who will be receiving a dose greater than 33 MCI, release of the
patient will be based on patient-specific dose calculations per Reg Guide 8.39, l
section C,1.3 and Appendix B. Providing the calculations show the the dose to
member of the public is less then 600 mrem, the procedyre will then be performed {
and the patient released imm,ediately following the therapy.
5. If the, specific c*:culations for a patient doen NOT meet the requiremants for
immediate release, then the therapy procedure will not bg performed et this facility.
' see attached sample calculations
,
4003 Lnke Otis Pkwy, Suite 101 = Anchamgn. AK 99508 * Clinic 907 563 3493 * Fax 907 5G12596
AW~rJ~~Tm! TnMM HEETWWD:A91057IC CEtiTER h .1 : 43 P. 3
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HEAL 1NSOUTH
- 0: agnostic Center of Anchorege-- -- -
--
Release of Patient Containing Iodine-131
in Compliance with 10 CFR 35.75
Using Information in Regulatory Guide 8.39
08-25-1999
Fatient names 8 AMPLE PATIENT
Date of birth: 1-1-60
Social Security or other ID number: 111111111
Treatment: Therapy for hyperthyroidism.
Parameters used in'the calculation:
RELEASE program version 1.0
Administered done 55 mci
Thyroid Uptako 00 %
Occupancy factor for period 0 to 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> .2
Occupancy factor from 8 hrs to total decay .25
Effective half life, extrathyroidal compartment .32 days
Effective half life, thyroidal compartment 5.2 days
Exposure rate constant, R/hr per mC1 at 100 cm 2.2
I-131 half life 8.04 days
Resultant dose to member of the general public:
Dome from first 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> 15 mrem
Dose from extrathyroidal component, 8 hrs to decay 7 mrem
Dose from thyroidal component, 8 hrs to decay 423 mrem
Total Effective Dose Equivalent 445 mrem
- (
Dose to Member of Public is less than 500 mrem.
- Patient may be released with appropriate instructions.
Physicist performing calculations:
- Retain this record for three years. *
I
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4003 Lake Otis Pkny., Suite 101 * Anchorage, AK 99508 * Clinic 907 563-3493 * Fax 907 561-2596
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e rr n . I W w U vWtr-~7MBTWOTFYGmVOYrTC~ TENTER No.1143 P. 4
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HEALTHSOUTH
DiagnosticCcntor ofAnchorago
_ . . . .-- -- -- - - -..
. . _ _ _ . _ _ . . _ _ _ _ _ _
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Ralease of Patient Containing Iodine-131
in Cotr.pliance with 10 CFR 3 5. 75
Using Information in Regulatory Guide 8.39 f
08-25-1999
l
Patient name SAMPLE PATIENT
Date of birth: 1 1-60
Social Security or other ID number: 111111
Treatment Post-surgical cancer therapy.
Parameters used in the calculation:
RELEACE program version 1.0
Adr inistered dose 200 mci
Thyroid Uptake 5 %
occupancy factor for period 0 to 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> .125
Occupancy factor from 8 hrs to total decay .25
Effective half life, extrathyroidal compartment .32 days
Effective half life, thyroidal compartment 7.3 days 3
F.xposure rate constant, R/hr per mci at 100 cm 2.2 i
I-131 half life 8.04 days
Resultant dose to member of the general public: l
Dose from first a hours 35 mrem
Dome from extrathyroidal component, a hrs to decay 113 mram )
Dose from thyroidal component, 8 hrs to decay 135 mram
Total Effective Dose Equivalent 202 mrem
Dose to Member of Public is less than 500 mrem. ***
- Patient may be released with appropriate instructions. ***
Physicist performing calculations: ,
- Retain this record for three years. *
4003 Lake Otis Pkwy., Suite 101 * Anchorage. AK 99508 * Clinic 907 563 3493 * Fax 907 561-2596
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HEi<HSOUTH
Diagnostic CenterofAnchorage
'~30'7
May 13, 1999
U.S. Nuclear Regulatory Commission-
Region IV
Nuclear Material Safety Section
611 Ryan Plaza Drive, Suite 400
Arlington, TX 76011-8064
RE: Radioactive Materials License #50-23214-01 / HealthSouth
Diagnostic Centers of Anchorage
To Whom It May Concern:
The purpose of this ar.e ndment is to request to change our
possession limit for performing I-131 therapies to 200 mci. We
wish to follow Reg Guide 8.39, " Release of Patients Administered
Radioactive Materials" for performing I-131 therapies over 30 mci
for both hyperthyroid a'nd thyroid carcinoma treatments providing ,
the patient meets the release criteria set forth in 8.39 for l
outpatients. If after interviewing the patient it is felt by the l
authorized user the patient does not meet these release criteria, i
the patient'will then.be sent to a local hospital authorized to {
perform in-patient therapies.
In addition, we are requesting to add 35.300 to this license in l
'
order to incorporate the existing line items for hyperthyroidism
and Strontium-89, as well as thyroid ablations and any new
radiopharmaceutical to be performed as an out-patient therapy. ,
Please refer to the attached license for training and experience i
for George Ladyman, M.D. and James Faires, M.D., both are I
authorized users on our license.
Please contact Tom Scott, CNMT, if additional information is i
required. I thank you in advance for your prompt attention I
'
regarding this matter.
Respectfully,
_
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John J. M Cormic , M.D. t<
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Radiatio Safety Officer 1.
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4003 Lake Otis Pkwy., Suite 101 * Anchorage, AK 99508 * Clinic 907 563-3493 * Fax 907 561-2596
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467328
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MATERIALS LICENSE CORRECTED COPY
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Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-43
, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35. 40 and 70 and in reliance on statements and representations :p
heretofore made by the licensee, a license is hereby issued authonzing the licensee to receive, acquire, possess, and transfer byproduct. ,p
I4 source, and special nuclear material designated below; to ose such material for the purpose (s) and at the place (s) designated below;to y
deliver or transfer such material to persons authonzed to receive it in accordance with the regulations of the applicable Part(s). This E
'
license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended. and is E
I
subject to all applicable rules, regulations and orders of the Nuclear Regulatory Comrr.ission now or hereafter in effect and to any (
conditions specified below.
% Licensee E
!5 In accordance with application dated ?-
5
l4 I' October 13
3' '**" ""*D*'
1994,
, 50-18244-01 is amended in
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b Alaska Regional Hospital ii
Ed its entirety to read as follows: .El
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P. O. Box 143889 4. Expiration date
h Anchorage, Alaska 99514-3189 March 31. 2000 h
g 5. Docket er d
Reference No. 010-14720
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- { o. Byproduct, source, and/or
7. Chermcal and/or physical 8. Maximum amount that licensee
may possess at any one t:me
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form Pl
under this license
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[ A. Any byproduct A. Any
radiopharmaceutical
A. As needed f
ldi material identified il
i.1, in 10 CFR 35.100 identified in >!
(5 10 CFR 35.100 (:
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qi B. Any byproduct 3. Any B. As needed W,
[dl material identified radiopharmaceutical
- f in 10 CFR 35.200 identified in @s
lid 10 CFR 35.200 s
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C. Any byproduct C. Any C. 3.3 Curies (not to !!
- f material identified radiopharmaceutical exceed 200 fj
d in 10 CFR 35.300 identified in millicuries per (l
f 10 CFR 35.300 container) ij
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a;4 D. Any byproduct D. Any crachytherapy D. 1 Curie it
material identified source identified ej
i in 10 CFR 35.400 in 10 CFR 35.400 bj
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% 9. Authorized use 3'
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k A. Medical use described in 10 CFR 35.100. ii
B. Medical use described in 10 CFR 35.200. N
C. Medical use described in 10 CFR 35.300.
D. Medical use described in 10 CFR 35.400. ;[p
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Amendment No. 16
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CONDITIONS
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10. Licensed material shall be used only at the licensee's facilities located at 2801
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De Barr Road, Anchorage, Alaska. l
11. The Radiation Safety Officer for this license is Bradley X. Cruz, M.D.
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12.
LicensedmateriallistedinItem6above~isonly.authorizedforuseby,orunderthef
supervision of, the following individuals for the materials and uses indicated. M
Authorized Users $
Material and Use i
Donald R. Rogers, M.D. $
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10 CFR 35.100, 35.200, 35.300 p
fej George H. Ladyman, M.D. 10 CFR 35.100, 35.200, 35.300
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James L. Faries, M.D. 10 CFR 35.100, 35.200, 35.300
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!i Julee X. Holayter, M.D. 10 CFR 35.100, 35.200, 35.300 '
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f4 Bradley K. Cruz, M.D. 10 CFR 35.100, 35.200, 35.300 $$
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.i Lester B. Lewis, M.D. 'N
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h Glenn R. Stewart, M.D. 10 CFR 35.300, 35.400 f
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s Geoffrey S. Hastings, M.D. 10 CFR 35.100, 35.200
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13.
The licensee shall maintain records of information related to decommissioning at theteI l'
address specified in Condition 10 above per the provisions of 10 CFR 30.35(g) until !a
g this license is terminated by the Commission. '
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$ 14. In addition to the possession limits in Item 8, the licensee shall further restrict :
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ti the possession of licensed material to quantities below the minimum limit specified
in 10 CFR 30.35(d) for establishing decommissioning financial assurance. l
jl 15. The licensee is authorized to transport licensed material only in accordance with
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M the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive p!
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Amendment No. 16 !
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g 16. Except as specifically provided otherwise in this license, the licensee shall
conduct its program in accordance with the statements, representations, and ylF ;
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procedures contained in the documents, including any enclosures, listed below, $.
except for minor changes in the medical use radiation safety procedures as provided lN
in 10 CFR 35.31. The Nuclear Regulatory Commission's regulations shall govern
unless the statements, representations, and procedures in the licensee's application fpL
and correspondence are more restrictive than the regulations.
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,, A. Application dated October 13, 1994 h
B. Letter dated March 10, 1995
(g C. Facsimile dated March 27, 1995
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