ML20148G192
| ML20148G192 | |
| Person / Time | |
|---|---|
| Issue date: | 05/16/1997 |
| From: | Bolling L NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Walter D ALABAMA, STATE OF |
| Shared Package | |
| ML20148G198 | List: |
| References | |
| NUDOCS 9706050222 | |
| Download: ML20148G192 (72) | |
Text
..
p WAY 16 Mill Mr. David K. Walter, Chairman SR-6 Committee, Conference of Radiation Control Program Directors, Inc.
c/o Alabama Department of Public Health The RSA Tower Division of Radiation Control, Suite 700 P.O. Box 303017 Montgomery, AL 36130-3017
Dear Mr. Walter:
We have reviewed the first draft of your 10 CFR Part 35 compatible rule, SSRCR (Part G) entitled, "Use of Radionuclides in the Healing Arts," dated March 1997.
Part G was reviewed relative to the Division 1 and 2 items of compatibility in Part 35.
Enclosed are specific comments on draft Part G required for compatibility. Several Division-3 comments, not required for compatibility, are also enclosed for your consideration.
We appreciate the opportunity to review and comment on this first draft. If you have any questions, please feel free to contact me.
Sincerely, D rir:inal signed by &
L. A. Bollins jfi*
Lloyd A. Bolling Office of State Programs
Enclosure:
As stated Distribution:
DIR RF (7S-77)
DCD (SP03)
SDroggitis PDR (YES / NO )
DOCUMENT NAME: G \\ TASK 7S77. LAB
- See previous concurrence.
' T2 receive s copy of this document. Indicato in the box:
"C" = Copy without attachment /enciesure "E" - Copy with attachment! enclosure "N" = No coq y q\\\\/
OFFICE OSP l
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r Mr. David K. Walter, Chairman l
SR-6 Committee, Conference of Radiation 1
- Control Program Directors, Inc.
Alabama Department of Public Health The RSA Tower Division of Radiation Control, Suite 700 i
P.O. Box 303017 Montgomery, AL 36130-3017
Dear Mr. Walter:
t We have reviewed the first draft of your 10 CFR Part 35 compatible rule, SSRCR (Part G) l sntitled, "Use of Radionuclides in the Healing Arts," dated March 1997.
I 4
Part G was reviewed relative to the Division 1 and 2 items of compatibility in Part 35.
i There are also several Division 3 items of compatibility in 10 CFR Part 35 which, if not adopted, would leave a logical gap in the implementation of a compatible Part G. Enclosed l
for your consideration are specific comments on draft Part G required for compatibility.
j We appreciate the opportunity to review and comment on this first draft.
j Sincerely, 4
4 i.
Lloyd A. Bolling Office of State Programs I
?-
Enclosure:
As stated I
Distribution:
DlR RF (7S-77)
DCD (SP03)
SDroggitis PDR (YES./ NO_)
CRCPD File RSAOs RSL0s DOCUMENT NAME: G:\\ TASK 7S77. LAB
- See previous concurrence.
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NAME LBoiling FXCameron DWRt BMorris RBangart DATE 04/03/97*
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- V ROUTING AND TRANSMITTAL SLIP DATE
- APRIL 4, 1997 I
PARALLEL CONCURRENCE REQUESTED INITIALS DAITE A
F. CAMERON, OGC 4
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LETTER TO:
DAVID K. WALTER, CHAIRMAN SR-6 COMMITTEE CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS, INC.
FROM:
LLOYD A. BOLLING I
OFFICE OF STATE PROGRAMS
SUBJECT:
SSRCR (PART G) "USE OF RADIONUCLIDES IN THE HEALING ARTS" I
4 YOUR CONCURRENCE IS REQUESTED BY C.O.B. APRIL 18 1997.
OSP CONTACT:
LLOYD BOLLING (415-2327) i 1
-PLEASE CALL KATHALEEN KERR (415-3340) FOR PICK UP.
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on SSRCR Volume 1-Draft, March 1997 Part G The following comments correct grammatical errors and technical omissions, provide current L
NRC regulatory terminology, or highlight differences with NRC requirements. The document was not reviewed to determine if assigned compatibility requirements have been meet, since it appears that the Office of State Programs staff has done this.
1.
Page G2 Medical Use definition - add an "an" " supervision of an authorized" 2.
Page G2 Misadministration definition - paragraphs (1), (2), (3), (4), (5),(6)(a), and (6)(b) -
change the phrase " patient or human subject" to " individual" - this change captures misadministrations for patients, human research subjects, and people who are neither patients or research subjects.
3.
Page G4 Visiting authorized nuclear pharmacist definition - add "an authorized" -
"means an authorized nuclear pharmacist who" 4.
Page G7 Section G8b 1.
Add "all authorized nuclear pharmacists" to paragraph 1 " Radiation Safety Officer, all authorized users, and all authorized nuclear j
pharmacists"- there is no reason to exclude the authorized nuclear phirmacist if the licensee has one.
~_
2.
Rearrange paragraph il for clarity to read " Management, all authorized users, and all authorized nuclear pharmacist shall participate in the program as required by the radiation safety officer for licensees that are not medical institutions."
5.
Page G9 Section G.10b. - add the radiation safety committee's duty to provide prior written permission for both visiting authorized users and visiting authorized nuclear pharmacists.
1 6.
Page G10, Section G.12 - The NRC requires the supervised individual to follow the instructions of the supervising authorized user this section does not.
7.
Page GIS, Section G.17. paragraphs a.ii, a.iii, a.iv, a.iv.(ii), b, and c revise all phrases
" patient or human research subject" and " patient" to read " individual" except as noted below:
l a.iii change "If the referring physician of patient or human research subject cannot" to "If the referring physician or individual receiving the misadministration cannot"
9
'V
- b. change "the patient or human research subject, and the patient's or human research subject's referring physician" to read "the individual who received the misadministration and that individual's referring physician, if applicable "
- c. change"cach other, patient or human research subjects, or the" to read "each other, to individuals receiving the misadministrations, or the" 8.
Page G17 Section G.20b - NRC requires range from highest dosage administered to a -
patient or human research subject to 1.11 megabequerels (30 microcuries). This lower level is consistent with the threshold for written directives associated with the use of sodium iodide.
9.
Page Gl9 Section G.22 1.
paragraph a. - the NRC requires all radiopharmaceutical dosages to be assayed.
This prevents gross errors to occur for patients receiving less than 30 microcurie dosages.
2.
paragraphs bii and ciii - It is not clear what radiopharmaceuticals would come under these paragraphs and how the paragraphs are used.
10.
Page G22, Section G26-Syringe labels - A distraction or emergency occuning between when the dose is drawn up for immediate use can result in administration errors. All -
syringes should be labeled.
I 1.
Page G23 Section G30 1.
This section permits the release ofindividuals with temporary implants, NRC regulations do not permit the release of patients or human research subjects with temporary implants unless they have been removed.
2.
paragraph a - change "an" to "any" " effective dose equivalent to any other" 12.
Page G51 - NRC did not allocate specific hours to didactic training or supervised experience and allow any combination as long ns the total is 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />.
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Mr. David K. Walter, Chairman
. SR-6 Committee, Conference of Radiation Control Program Directors, Inc.
Alabama Department of Public Health The RSA Tower h
Division of Radiation Control, Saite'700 P.O. Box 303017 Montgomery, AL 36130-3017
)
Dear Mr.-Walter:
We have reviewed the first draft of your 10 CFR Part 35 compatible rule, SSRCR (Part G) entitled, "Use of Radionuclides in the Healing Arts," dated March 1997.
Part G was reviewed relative to the Division 1 and 2 items of compatibility in Part 35.
. There are also several Division 3 items of compatibility in 10 CFR Part 35 which, if not adopted,, would leave a logical gap in the implementation of a compatible Part G. Enclosed for your consideration are specific comments on draft Part G required for compatibility.
We appreciate the opportunity to review and comment on this first draft.
Sincerely, i
Lloyd A. Bolling Office of State Programs
Enclosure:
As stated i
j
' Distribution:
' DlR RF (7S 77)
DCD (SP03)
SDroggitis PDR (YES / NO )
DOCUMENT NAME: G:\\ TASK 7S77.LA
- See previous concurrence.
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copy with.et.en,n.nt/.ncio.ur.
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NAME-LBoiling FXCameron DCool BMorris RBangart 4
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OLP FILE CODE: SP-S-13 I
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LETTER T0:
DAVID K. WALTER, CHAIRMAN SR-6 COMMITTEE CONFERENCE OF RADIATION CONTROL PROGRAM DIRECTORS, INC.
1 FROM:
LLOYD A. BOLLING 0FFICE OF STATE PROGRAMS
SUBJECT:
SSRCR (PART G) "USE OF RADIONUCLIDES IN THE HEALING ARTS"
.)
YOUR CONCURRENCE IS REQUESTED BY C.O.B. APRIL 18 1997.
f OSP CONTACT:
LLOYD BOLLING (415-2327) j PLEASE CALL KATHALEEN KERR (415-3340) FOR PICK UP.
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f lk$f IRST DRAFT FOR REV10 AND COMMENT S GGESTED STATE REGULATIONS PART G "USE OF RADIONUCLlDES IN THE HEALING A
S" Divisi n 1 Comments
)
1.
S&c. G.2 - Definitions.
- a. "
dical use"... supervision of ari and authorized user. (See Page G2)
)
- b. "Misa ministration" insert irdividual and delete p;tiert er hum:n ::=::ch eub eet. (See Pages G2 & G3) t (6)(b) Chan com to fems.
- c. Definition of "
armacist" is missing.
Division 2 Comments 1
1.
Sec. G.16 - Quality Man ement Prooram.
Modifications to the Quality anagement Program must be submitted to the i
" Agency" within 30 days of t change, as detailed in 10 CFR 35.32(e).
(See Page G15) 2.
Ege. G.17 - Records, Notifications, nd Reoorts of Misadministrations.
- a. ii, thru iv.(ii) and b. - delete "petie\\r. :: Sum:n ::::::ch cuhl:: " and insertl
" Individual.". (See Pages G.15 & G.1 Also, add the following to the end of a.ii.:
"To meet the requirements of this section, th notification of the individual receiving j
the misadministration may be made instead to e individual's responsible relative or i
guardian, when appropriate."
J l
3.
Sec. G.20 - Possession Use, Calibration. and Check f Dose Cplibrators.
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i
- b. i. & ii. - delete 50 uCi and insert 30 uC1. ~lsee Pa3.17)
N b A v'
- b. ii. - photon energies are missing. See 10 CFR 35.50( (1)&(2)
W'M8 kA 1
- 6. 5. - use the wording in 10 CFR 35.50 (b)(3).
L42< d a~
- c. Insert 10 uCi and delete 30 uCi.See 10 c rft 3r50Cch '
EO N
- N2),
14A A 4g% h 4.
Cec. G 22 - Assav of Radiooharmaceutical Dossoe.
M N'S Delete this entire section and replace it with two new sections wor d in accordrsnce with 10 CFR 35.52 and 35.53. (See Page G.19)
Division 3 Comments (Jo comments were identified in this area, i
i
I e neu
- 9 1
UNITED STATES
- s.
j NUCLEAR REGULATORY COMMISSION i
WASHINGTON D.c. 2065H001 t* *... + /
May 16, 1997 j
Mr. David K. Walter, Chairman SR-6 Committee, Conference of Radiation Control Program Directors, Inc.
clo Alabama Department of.Public Health l
The RSA Tower Division of Radiation Control, Suite 700 P.O. Box 303017 Montgomery,- AL 36130-3017
Dear Mr. Walter:
We have reviewed the first draft of your 10 CFR Part 35 compatible rule, SSRCR (Part G) i entitled, "Use of Radionuclides in the Healing Arts," dated March 1997.
Part G was reviewed relative to the Division 1 and 2 items of compatibility in Part 35.
Enclosed are specific comments on draft Part G required for compatibility. Several Division-3 comments, not required for compatibility, are also enclosed for your i
consideration.
We appreciate the opportunity to review and comment on this first draft.
Sincerely, j
,ft m'-
\\
Lldyd A. Bolling Office of State Progra s
Enclosure:
As stated
REVIEW AND COMMENT SUGGESTED STATE REGULATIONS PART G "USE OF RADIONUCLIDES IN THE HEALING ARTS" [Unless otherwise noted, changes are shown by redline (additions) and strikeout (dc!ctions)]
Division 1 Comments Sec. G.2 - Definitions. (10 CFR 35.2)
" Medical use"... supervision of sh and authorized user. (Page G2)
" Misadministration" insert Individual and delete peticrt cr Sumer roccerch cubject in all places as appropriate. (Paragraphs (1),(2),(3),(4),(5),(6)(a) and (6)(b)). This change will capture misadministrations for patients, human research subjects, and people who are neither patients nor human research subjects. (Pages G2 & G3)
~
6.b. Change tem to r' ems.
Definition of " Pharmacist" is missing.
" Visiting authorized nuclear pharmacist" means a s.n'autho ized nuclear.....(Page G4) l Division 2 Comments 1.
Sec. G.10 Radiation Safety Committee. (10 CFR 35.22(b)(2)(ii))
i b.ii. A new or modified sentence is needed to address the committee's duty to review and approve (or disapprove) of both visiting authorized users and visiting authorized nuclear pharmacists. (Page G9) 2.
Sec. G.12 Suoervision. (10 CFR 35.25(a)(2))
a.i. Add the following requirement to this paragraph "the supervised individual is required to follow the instructions of the supervising authorized user." (Page G10) 3.
Sec. G.16 - Quality Manaaement Proaram. (10 CFR 35.32 (e))
- e. Add the following sentence: Modifications to the Quality Management Program must be submitted to the " Agency" within 30 days of the change. (Page G15) 4.
Sec. G.17 Records. Notifications, and Reports of Misadministrations. (10 CFR 35.33(a)(2),(3)(b)&(c) a.
G.17 a.ii, through iv.(ii), b. and c. - insert " individual," and delete "petiert Or humcn roccc ch cubject". (Pages G.15 & G.16) b.
G.17 a.ii. add the following to the end of the parare ph: "To meet the requirements of this section, the notification of.
.ndividual receiving the misadministration may be made instead to the individual's responsible relative or guardian, when appropriate." (Page 15) c.
G.17 a.iii. the third sentence should be changed to read "If the referring physician or individual receiving the misadministration cannot....." (Page G15)
[
b
. s d.
G.17 b, the second sentence should be changed to read "The record shall contain the names of allindividuals involved (including the prescribing physician, allied health personnel, the individual who received the misadministration and the referring physician),......" (Page G16) e.
G.17 c. should be changed as follows: "Aside from the notification requirement, nothing in G.17a. and G.17b. shall affect any rights or duties of licensees and physicians in relation to each other, the individual who received the misadministration or the individual's responsible relatives or guardians." (Page G16) 5.
Sec. G.20 - Possession. Use. Calibration. and Check of Dose Calibrators.
(10 CFR 35.50 (b)(1)(2)&(3))
G.20 b.ii. Delete the existing paragraph, and add the paragraph as detailed in 10 CFR 35.50(b)(2). (Page G17)
G.20 b.iii. Use the wording in 10 CFR 35.50 (b)(3). (Page G17) 6.
Sec. G.22 - Assay of Radiocharmaceutical Dosaae. (10 CFR 35.52 & 35.53)
Delete this entire section and replace it with two new sections worded in accordance with 10 CFR 35.52 and 35.53. (Page G.19) 7.
Sec. G.30 - Release of Individuals Containina Radiocharmaceuticals or implants.
G.30 a. Change the "an" to "any" before the phrase "other individual" in the 3rd line. (Page G.23)
G.30 a. NRC does not permit the release of patients with temporary implants until the sources have been removed. This provision should be reflected in paragraph (a).
(Page G23)
Division 3 Comments 1.
Sec. G.8 ALARA Proararm (10 CFR 35.20)
G.8 b.i. Change as follows: The management, Radiation Safety Officer, and all authorized users [and'all alithbrizedjnucleaffpharmacists'shall.... (Page G7)
G.8 b.ii. Rearrange paragraph ii for c!arity to read " Management, all authorized users, and all authorized nuclear pharmacists shall participate in the progracn as required by the radiation safety officer for licensees that are not medical institutions." (Page G7) 2.
Sec. G.26 - Svrince Labels. (10 CFR 35.60(bi)
All syringes should be labeled. (Page G22) 3.
Sec G.78 - Tiainina for an Authorized Nuclear Pharmacist. (10 CFR 35.980(b))
NRC does not allocate specific hours to didactic training or supervised experience.
Any combination totalling 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is accepted. (Page G51)
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Sec. O.1 0.2 l
+
SSRCR Volume 1-Draft, March 1997 i.
PARTG USE OF RADIONUCLIDES IN THE HEALING ARTS b G.1. Pumose and Econe Part G establishes requirements and provisions for the production, l
preparation, compounding and use ofradionuclides in the healing arts and for issuance eflicenses authorizing the medical use of this material s' Wprovision fofresisch"msaliiiii(Esisifibbjsts.
These requirements and provisions provide for the protection of the public health and safety.
i requirements and provisions ofPart G are in addition to, and not in substitution for, others in these regulations.' The requirements and provisions of these regulations apply to applicants and licensee!
subject to Part G unless specifically exempted.
Eec G 2 - Definitions As used in Part G, the following dermitions apply:
" Address of use" means the building or buildings that are identified on the license and where radio) material may be produced, prepared, received, used, or stored.
F
' Area of use" means a portion of a physical stmeture that has been set aside for the purpose of i
producing, preparing, receiving, using, or storing radioactive material.
l
" Authorize (Nuclear' Pharmacist"means a pharmacidwho'IR
~
i 1[ Board ceriified aia nuclear phannacist by'th B6ard ofPharmaceUtical Specialties;:
2.1destified u an inuthorized riucleaFphannscisi on an AgencT AgreementLSfaie, Licensing'S material in the practice of nucleaf pennicy; o]rU.S Nuclear Regulator t
3l.71dsstified aian authorizedntiilisipharmicist an a p6mit issued 6 ~an/ Agency [, A
~
Licensing State or U.S. Nuclear Re' ulatory Cominission (NRC)]' specific liceEsce ;6f broad s l
g ishorized to pennit the use of radioactiv'e material is the. practice ofnuclear: pharmacy,
' Authorized user" means a practitioner of the healing arts who is identified as an authorized user on an Agency [, Agreement State, Licensing State or the Nuclear Regulatory Commission] license that authorizes the medical use of radioactive material.
1
' Brachytherapy" means a method of radiation therapf n which sealed sources are utilized to deliver a i
i radiation dose at a distance ofup to a few centimeters, by surface, intracavitary, or interstitial applica!
' Dedicated check source" means a radioactive source that is used to assure the constant operation o 1
i radiation detection or measurement device over several months or years. This source may also be usej for other purposes.
- " Diagnostic clinical procedures manual" means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical G1 J
,,. c acR sane 1.Drnp, Atarch 1997 see.o.1 procedures; where each diagnostic clinical procedure has been approved by the authorized user and t
j includes the radiopharmaceutical, dosage, and route of administration.
' Management" means the chief executive officer or that individual's designee.
I
' Medical institution" means an organization in whhh several medical disciplines are practiced.
. Medical use" means the intentional intemal or external administration of radioactive material, or the radiation therefrom, to isitie5G Wh4sEhisiIAh76tvistslisiisEdiiIEiErvisiosl5fiIisi6it16dNd user i-- =; 0 y.-A=.40m1, L.,
l 4.
" Misadministration" means the administration of:
(1)
A radiopharmaceutical dosage greater than 1.11 magMquerels (30 pCi) of either
[
sodiumiodide I.125 or I-131:
i (a)-
Involving the wrong patient M 1AiniE reMaEchliUbjset or wrong radiopharmaceutical; or j
(b)
When both the administered dosage differs from the prescribed dosage by more
[
than 20 percent of the prescribed dosage and the diference between the j
administered dosage and prescribed dosage exceeds 1.11 megabecquerels (30 i
pCi);
(2)
A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131:
(a)
InvoMng the wrong patient ;oihuman iidhrcinbjkt, wrong radiopharmaceutical, or wrong route oPadministration; or i
(b)
When the administered dosage diEers f rom the prescribed dosage by more than 20 percent of the prescribed dosage; 1
(3)
A gamma stereotactic radiosurgery radiation dose:
4 (a)
Involving the wrong patient Eliuisn'NMiich" subject or wrong treatment site; or n
(b)
When the calculated total administered dose diners from the total' prescribed dose by more than 10 percent of the total prescribed dose; (4)
A teletherapy radiation dose:
(a)
InvoMng the wrong patient khumsifihisichTsuby6t, wrong mode of treatment, or wrong treatment site; or (b)
When the treatment consists of 3 or fewer fractions and the calculated total administered dose diners from the total prescribed dose by more than 10 percent 4
of the total prescribed dose; or G2
,.o Sec. G 2 SSRCR Volume 1-Draft. March 1997 (c)
When the calculated' weekly administered dose exceeds the weekly prescribed dose by 30 percent or more of the weekly prescribed dose; or (d)
When the calculated total administered dose difers from the total prescribed dose by more than 20 percent of the total prescribed dose; (5). - A brachytherapy radiation dose:
(a)
Involving the wrong patient ikWMFaiAi&E6]Et, wrong radionuclide, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or (b)
Involving a sealed source that is leaking; or (c)
When, for a temporasy implant, one or more sealed sources are not removed upon completion of the pracedure; or (d)
When the calculated administered dose difers from the prescribed dose by more than 20 percent of the prescribed dose; (6)
A diagnostic radiopharmaceutical dosage, other than quantities greater than 1.11 megabecquerels (30 pCi) of either sodium iodide I-125 or I-131, both:
(a)
Involving the wrong patient or h'uiman research snject, wrong radiopharmaceutical, wrong route of administration, or when the administered dosage difers from the prescribed dosage; and (b)
When the dose to the patient or hunddreseard'Mhject exceeds 50 millisieverts (5 rem) effective dose equivalent or 500 millisieverts (50 rem) dose equivalent to any individual organ.
" Mobile nuclear medicine service" means the transportation and medical use of radioactive material.
" Output" means the exposure rate, dose rate, or a quantity rebted in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.
' Prescribed dosage" means the quantity of radiopharmaceutical activity as documented:
(1)
In a written directive; or -
'(2)
Either in the diagnostic clinical procedures manual or in any appropriate record in accordance with the directions of the authorized user for diagnostic procedures.
" Prescribed dose" means:
(1)
For gamhis stereotactic radiosurgery, the total dose as documented in the written i
directive; or G3
- . e.
e SSRCR 1%me!-DrqA Mash 1997 Sec. G.2 (2)
For teletherapy, the total dose and dose per fraction as documented in the written
~ directive; or (3)
For brachytherapy, either the total source strength and exposure time, or the total dose, as documented in the written directive.
[* Recordable event" means the administration of:
(1)
A radiopharmaceutical or radiation without a written directive where a written directive is required; (2)
A radiopharmaceutical or radiation where a written directive is required without daily recording of each administered radiopharmaceutical dosage or radiation dose in the appropriate record; (3)-
A radiopharmaceutical dosage greater than 1.11 megabecquerels (30 pCi) of sodium iodide 1-125 or 1-131 when both the administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage, and the difference between the administered dosage and the prescribed dosage exceeds $55 kilobecquerels (15 pCi);
(4)
A therapeutic radiopharmaceutical dosage, other than sodium iodide I-125 or I-131, when the administered dosage differs from the prescribed dosage by more than 10 percent of the prescribed dosage; (5)
A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by 15 percent or more of the weekly prescribed dose; or (6)
A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than 10 percent of the prescribed dose.]
" Teletherapy physicist" means an individualidentified as the qualified teletherapy physicist on an Agency heense.
" Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.
"Visitirigiuthkized miclear pharihacist'f 55ans a nucisaTpharmacist"who islimotlideslified'on' tis IIcense lof the licenseejeingsisitied
" Visiting authorized user" means an authorized user who is not identified on the license of the licensee being visited.
G4
l
,.e Sec.O.2.G.4
.ESRCR Volume 1-Draft, Alarch 1997
" Written directive
- means an order in writing for a specific patientWha5ElAdiclisubject, dated and signed by an authorized user prior to the administration of a radiopharmaceutical or radiation, except as specified la (6), containing the following information:
(1)
For any administration of quantities greater than 1.11 megabecquerels (30 pCi) of sodium iodide I-125 or I-131: the radionuclide, and dosage; or (2)
For a therapeutic administration of a radiopharmaceutical other than sodium iodide I 125 or 1-131: the radiopharmaceutical, dosage, and route of administration; or (3)
For gamma stereotactic radiosurgery: target coordinates, collimator size, plug pattern, and total dose; or (4)
For teletherapy: the total dose, dose per fraction, treatment site, and overall treatment period; or (5) - For high-dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, and total dose; or (6)
For all other brachytherapy, (a)
Prior to implantation: the radionuclide, number of sources, and source strengths; and (b)
After implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time (or, equivalently, the total dose).
General Regulatory Requirements Enci GW Provisinnifn'r RewrciInvo vina M&h! hh8 WEcassocia cnducsreseari:Einfoleinghinnasub} ids"Ging^ndiosneiistsialprovidedjtistthe Seenfch is conducted l funded, supported,'or regulated $fede allacecy whi6hlhis implemented the poderal Policy for the Prot'ection ofHumsn Subjects.1 Otherwise, a licensee'shall apply for and receive liipprost of a specific amendmentjo its Agsicy license before conductiniiuc' h research.Thoth~ types"of licensees"shall,'at a'mi' imum, obtain informed consent fWithe%inan'iubjectsiaiul otsala prior review n
knd approval of thi research activities by an."Instituticsal Revin Bodd".infaccordance with.the ineaning of these terms as defined and described in the FederalPolicifor the Prosee' tion"orHuman Subjeats.
WG 4."FDEOther' Fin /m13A StatARin6ir~eiki Nothing in Pan'G relieves tisi licensee froin complying with ap~plicable FDA, other' federal,' and state requirements governing radioactive drugs o' rEdevices.
G5
SSRCR l'oJunei.Drqh Mach 1997 i
Sec. 0.5 0.8 s c e 4 G 3 Itr.n w Rene;rco No person shall manufacture, produce, prepare, compound, acquire, receive, possess, use, or a.
transfer radioactive material for medical use except in accordance with a specific license israed pursuant to these regulations.
b.
Unless prohibited by license condition, an individual may receive, possess, use, or transfer radioactive material in accordance with the regulations in Part G under the supervision of an authorized user as provided in 64&G.12)
$I UnidijI6isNN55ciasiEMEsiih3Md513dfl ejisNGadioniimEiriaiM i
iniedlis) usd in accordance with the regblations in Part G under the supervision of an issthorized nuclear pharmscist or an authorized ' user 'as provided in G.12)
See 64G 6 - Licente Amendments A licensee shall apply for and receive a license amendment:
Before using radioactive material for a method or type of medical use not permitted by the license a.
issued under Part G; b.
Before permitting anyone, except a visiting authorized user described in 64+ G.13, to work as an authorized user or a visiting ' authorized nuclear phairmacis; described.in Gl14, tRw6rk as an authoriksd nElear pharmacist under the license; Before changing a Radiation Safety Officer or Teletherapy Piiysicist; c.
d.
Before receiving radioactive material in excess of the amount authorized on the license; i
Before adding to or changing the areas of use or address or addresses of use identified in the e.
application or on thelicense; and f.
Before changing statements, representations, and procedures which are incorporated into the license.
See Fr4G'7 - Notifications A licensee shall notify the Agency in writing within 30 days when an authorized user, Radiation Safety Officer, or Teletherapy Physicist, permanently discontinues performance of duties under the license.
G6
_..i
,\\
Sec. 0.8 - G,9
~
SSRCR Volumei. Draft, March 1997 Additional Requirements he G6G't - ALARA Prnaram Each licensee shall develop and implement,a written program to maintain radiation doses and a.
releases of radioactive material in effluents to unrestricted areas as low as reasonably achievable (ALARA) as defined in Part A of these regulations.
b.
To satisfy the requirement offr6rG.8al:
i.
The management, Radiation Safety Officer, and all authorized users shall participate in the establishment, implementation, and operation of the program as required by these regulations or the Radiation Safety Committee; or ii.
For licensees that are not medical institutions, management imd all authorized users'aSd 'all
- auth' rized" nuclear pharmacists shall participate in the program as required by the
^
o Radiation Safety Officer.
The ALARA program shall include an annual review by the Radiation Safety Committee for c.
licensees that are medicalinstitutions, or management and the Radiation Safety Officer for licensees that are not medicalinstitutions, of summaries of the types and amounts of radioactive material used, occupational dose reports, and continuing education and training for all personnel who work with or in the vicinity of radioactive material. The purpose of the review is to ensure that individuals make every reasonable effort to maintain occupational doses, doses to the general public, and releases of radioactive material as low as reasonably achievable, taking into account the state of technology, and the cost ofimprovements in relation to benefits.
d.
The licensee shall retain a current written description of the ALARA program for the duration of the license. The written description shallinclude:
i.
A commitment by management to keep occupational doses as low as reasonably achievable; ii.
A requirement that the Radiation Safety Officer brief management once each year on the radiation safety program; iii.
Personnel exposure investigational levels as established in accordance with CE...;;.G.10b.viii; that, when exceeded, will initiate an investigation by the Radiation Safety Officer of the cause of the exposure; and iv.
Personnel exposure action levels that, when exceeded, will initiate a prompt investigation by the Radiation Safety Officer of the cause of the exposure and a consideration of actions that might be taken to reduce the probability of recurrence.
G7
a
,a A
f.
SSRCR Volume 1-Drqft. Alarch 1997 3
Sec. 0.5 - G.8 j
Rae 64G 9. Radiatinn Rafetv OEcar A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation 1
a.
safety program The licensee, through the Radiation Safety Officer, shall ensure that radiation i
safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's radioactive material program.
b.
The Radiation Safety Officer shall:
i.
Investigate overexposures, misadministrations, accidents, spills, losses, thefts, j
unauthorized receipts, uses, transfers, and disposals, and other deviations from approved radiation safety practice and implement corrective actions as necessary, ii.
Implement written policy and procedures for:
(1)
Authorizing the purchase of radioactive material; (2)
Receiving and opening packages of radioactive material; (3)
Storing radioactive material; (4)
Keeping an inventory record of radioactive material; (5)
Using radioactive material safely; (6)
Taking emergency action if control ofradioactive material is lost; (7)
Performing periodic radiation surveys; (8)
Performing checks and calibrations of survey instmments and other safety equipment; i
(9)
Disposing of radioactive material; (10)
Training personnel who work in or frequent areas where radioactive material is used or stored; and (11)
Keeping a copy of all records and reports required by the Agency regulations, a copy of these regulations, a copy of each licensing request and license and amendments, and the written policy and procedures required by the regulations; and iii.
For medical use not sited at a medical institution, approve or disapprove radiation safety j
program changes with the advice and consent of management prior to submittal to the j
Agency for licensing action; or G8 4
l I
sec.o.s.o.9 SSRCA Volumei. Draft, March 1997 iv.
For medical use sited at a medical institution, assist the Radiation Safety Committee in the performance ofits duties.
he e40'io Rarfintion Safety Commbe Each medical institution licensee shall establish a Radiation Safety Committee to oversee the use of. radioactive material.
The Committee shall meet the following administrative requirements:
a.
i.
Membership must consist of at least 3 individuals and shall include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, a representative of the nursing service, and a representative ofmanagement who is neither an authorized user nor a Radiation Safety Officer. Other members may be included as the licensee deems appropriate; ii.
The Committee shall meet at least once each calendar quaner; iii. - To establish a quorum and to conduct business, one-half of the Committee's membership shall be present, including the Radiation Safety Officer and the management's representative; iv.
The minutes of each Radiation Safety Committee meeting shall include:
(1)
The date of the meeting; (2)
Members present; (3)
Members absent; (4)
Summary of deliberations and discussions; (5)
Recommended actions and the numerical results of all ballots; and (6)
Documentation of any reviews required in 64c G8c.' and EHHrG3015.;
The Committee shall provide each member with a copy of the meeting minutes, and retain v.
one copy until the Agency authorizes its disposition.
b.
To oversee the use of ficensed material, the Committee shall:
i.
Be responsible for monitoring the institutional program to maintain occapational doses as low as reasonably achievable; ii.
Review, on the basis of safety and with regard to the training and experience standards of Part G, and approve or disapprove any individual who is to be listed as an authorized user, a' n"muthnrinti nuclear nhsm eini"the Radiation Safety Officer, or Teletherapy Physicist before sub'mitting a license application or request for amendment or renewal; G9
SSRCR l'olum1 Drap, March 1997 Sec. 0.9 0.10 iii.
Review on the basis ofsafety and approve or disapprove each proposed method of use of radioactive material; iv.
Review on the basis ofsafety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove procedures and radiation safety program changes prior to submittal to the Agency for licensing action; Review quanerly, with the assistance ofthe Radiation Safety Officer, occupational
- v. -
' radiation exposure records of all personnel working with radioactive material;
- vi.
Review quanerly, with the assistance of the Radiation Safety Officer, all incidents involving radioactive material with respect to cause and subsequent actions taken; vii.
Review annually, with the assistance of the Radiation Safety Officer, the radioactive material program; and viii.
Establish a table ofinvestigational and action levels for occupational dose that, when exceeded, will initiate investigations and/or considerations of action by the Radiation Safety Officer.
' Sec &9G 11 - Statement of Anthnritien and Remnonsibilitien A licensee shall provide sufficient authority and organizatienal freedom to the Radiation Safety a.
Officer and the Radiation Safety Committee to:
i.
Identify radiation safety problems; ii.
Initiate, recommend, or provide solutions; and lii.
Verify implementation of corrective actions.
b.
A licensee shall establish in writing the authorities, duties, responsibilities, and radiation safety activities of the Radiation Safety Officer and the Radiation Safety Committee.
Sec GMG 12 - Sunervision A licensee who permits the receipt, possession, y.vd-d.uw yn.y-m.v..,
...yvo.,0.., use, or a.
transfer of radioactive material by an individual under the supervision of an authorized user as allowed by fr9G.5 shall:
i.
Instruct the supervised individual in the principles of radiation safety appropriate to that individual's use of radioactive material and in the licensee's written quality management program; ii.
Periodically review the supeivised individual's use of radioactive material, the records kept to reflect this use, and provide reinstruction as needed; GIO
2 l
Sec. 0.12 G.I3 1
SSRCR l'olume1-Draft, March 1997 iii.
Require an authonzed user to be immediately available to communicate with the j
supervised individual; and
~
j iv.
Require that only those individuals permitted under state and local regulations and 1.
}
specifically trained, and designated by the authorized user, be permitted to administer radionuclides or radiation to patients Elisasin resessin subjects.
1.
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sf radioactive material by an 1.ulividual under the supervision'of an authorizsd nuclear i
or an authorized user as allowed by G.5 shall:
a i
1.
Inssuct tis iupervissd indiQiddal in"theh44!dion'6f ridionetive matkrial for msdical use
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and the principles of and procedures for radiation safetyTand in the licensee's. written
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radioactive material for. medical use sed the reckds' kept to ieflect that work.
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- Eac GMG'13 - Visitino Authorized User.
A lice 1see may permit any visiting authorized user to use licensed material for medical use under a.
the terms of the licensee's license for 60 days each year if:
i.
The visiting authorized user has the prior written permission of the licensee's management a.4, if the use occurs on behalf of an institution, the institution's Radiation Safety Committee, 1
11.
The licerdee has a copy of an Agency [, Agreement. State, Licensing State or the Nuclear Regulatory Commission] license or a pennit issued by an Agency; specific lilcensee of i
Gil
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SSRCRl'ohemi Drep. March 1997 sec.o.14 o.1s bidailsc65ijhat'iisduidfiisdidpermittheii jfddidistiMistiiristWthiliEacticifor medicine that identifies the visiting authorized user by name as an authorized user for i
medical use; and j
1 l
1 iii.
Only those procedures for which the visiting authorized user is specifically authorized by an Agency [, Agreement State, Licensin8 tate or the Nuclear Regulatory Commission)
S i
license are performed by that individual.
b.
A licensee need not apply for a license amendment in order to permit a visiting authorized user to use licensed material as described in 6-H3G '1.3s.
c.
A licensee shall retain copies of the records specified in fr-Hr&da' [for 3 years from the date of
. the last visit].
J i
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s.. A fA lice.nsee may pemu,t any visitmg authonEES, nun..clearnpharma..,cist to use h.,-. censed material for
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i nuclear phadnacj use under the terms 6f the licerisee's license fof~60 days each year;if;
.f 17Mil?M The visiting aEthdrised' nuclear p, harmicist; has the prior written.permissionforthe licensee's management and,'if the use occurs on behalfof an institution,;the; institution's
) -
Radiation Safety Committee!
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The licensee.....,..has a copy of an AgencyL, Agreement State, Licensing State or NRC] licenAe or'a permit issued by an'Agenh speci6c licensee of thoad scopslthaifis authorized io
~
permit the use'of radioactive _ material inIthe practise of n6sisar; pharinacy that identifies
~
i the visiting authorizsd'nudear pharmacist by name as'an' adthorized nuclear)harmacist for nuclearpharmacyuse(and? j kMA' licensee nesd hot ipply for ilicense"sinendmeniin"6rder"td)Einilinisiting' authorized suelear pharmacistjo. useLlicensed maferial as'.. described iit G;14a; Et MIhcensefsliall rstain i:opiAs'of ths recordsMifinMdifoE3}eks%tEthidsbl5fjh' i
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. last' visa).
4 Sec GM'15 - Mobile Nuclear Medicine Service Administrative Reauirements 3
The Agency shall lic.ense mobile nuclear medicine services and/or clients of such services. The 3
a.
mobile nuclear medicine service shall be licensed if the service receives, uses or possesses radioactive material. The client of the mobile nuclear medicine service shall be licensed if the client receives or possesses radioactive material to be used by a mobile nuclear medicine service.
G12
8 4e
/
I-
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Sec.G.16 SSRCR Veheme1. Draft. March 1997
~
b.
Mobile nuclear medicine service licensees shall retain for the duration of service a letter signed b i
the management of each location where services are rendered that authorizes use ofradioactive material. If the client is licensed, the letter shall document procedures for notification, receipt, storage and documentation of transfer of radioactive material delivered to the client's location for j
use by the mobile nuclear medicine servicg.
1 i
c.
A mobile nuclear medicine service shall not have radioactive material delivered directly from the manufacturer or the distributor to the client's address of use, unless the client has a license.
Radioactive material delivered to the client's add <ess of use shall be received and handled in conformi.nce with the client's license.
a.
i d.
A mobile nuclear medicine service shall inform a responsible individual, such as a representative of j
management or a Registered Nurse in charge of the patient oif hinianWeedclIssbjecii or the Registered Nurse in charge of the nursing unit, who is on site at each client's address of use at the time that radiopharmaceuticals are being administered.
see s+9GJs. Onnuev Management Pmeram 4
Each licensee shall establish and maintain a written quality management program to provide a.
assurance that radioactive material or radiation therefrom will be administered as directed by the
{
authorized user. The quality management program shall include written policies and procedures to meet the following specific objectives:
i j _
i.
That, prior to administration, a written directive is prepared for:
[
(1)
Any teletherapy radiation dose; 1
i (2)
Any gamma stereotactic radiosurgery radiation dose; 4
i.
(3)
Any brachytherapy radiation dose; 2-(4).
Any administration of quantities greater than 1.11 megabecquerels (30 pCi) of cither sodium iodide I-125 or I-131; or (5)
Any therapeutic administration of a radiopharmaceutical, other than sodium iodide i
1-125 or I 131; (NOTE: If, because of the patient's Eliss0ireseirc(subject's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's or hsmdresearch subject's hePh, an oral revision to an existing written directive will be acceptable, provided that the e!J revision is documented immediately in the patient's or huinan reiiearcli"so' bject's record and a revised written directive is signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision. Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to the administration of the radiophatmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery j
dose, the teletherapy dose, or the next teletherapy fractional dose, If, because of the G13
~-~
-7.-
l 3SRCR l'ahome1-DrqR. March 199?
a.
Sec.G.16 emergent nature of the patient's fiMdiiih?hiAiiinsSEPs condition, a delay in order to 3
provide a written directive would jeopardize the patient's (liina0 isarch?subj ct s i
health, an oral directive will be acceptable, provided that the information contained in the j
oral directive is documented immediately in the paitient's erh=ihiesiiich/shbjict's
]
j record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive.)
}
ii.
That, prior to each administration, the patient's $EiEE(r&AEisi @fi identity is l'
verified by more than one method as the individual named in the written directive; -
t lii.
That final plans of treatment and related calculations for brachytherapy, teletherapy, and 1
i gunma stereotactic radiosurgery are in accordance with the respective written directives; l
iv.
That each administration is in accordance with the written directive; and That any unintended deviation from the written directive is identified and evaluated, and v.
H
-appropriate action is taken.
i
[
[b.
Fach licensee shall:
i.
Develop procedures for and conduct a review of the quality management program including, since the last review, an evaluation of a representative sample ofpatient or
)
l hurMn research" subject administrations, all recordable events, and all misadministrations
{
j to verify compliance with all aspects of the quality management program; these reviews j
i shall be conducted at intervals no greater than 12 months; l
ii.
Evaluate each of these reviews to determine the effectiveness of the quality management 2
program and, if required, make modifications to meet the objectives offrt9rG.16a.; and 1
iii.
Retain records of each review, including the evaluations and findings of the review, in an
,1 auditable form for 3 years.
The licensee shall evaluate and respond to each recordable event, within 30 days after discovery c.
4 of the recordable event, by:
i.
Assembling the relevant facts including the cause; i
li.
. Identifying what, if any, corrective action is required to prevent recurrence; and
)
iii.
Retaining a record, in an auditable form, for 3 years, of the relevant facts and what corrective action, if any, was taken.
j d.
- Each licensee shall retain:
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4 i
i.
Each written directive; and G14 N
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.SSRCA VolumI.DraA.med 1997 ii.
A reccrd creach administered radiation dose or radiopharmaceutical dosage where a written directive is required in C. Ue.i.G.16a.'i., in an auditable form, for 3 years after the j-date of administration.
The licensee may make modifications to the ' quality management program to increase the e.
program's efficiency provided the program,'s effectiveness is not decreased).
It@Esch^appliciis ibiiieidliE&In, EiippliME'shall iubnet i%risenisalitiinEGsierEhi
^
M as part of the.py& st$oti for a license,ind shall implement thiiprogrMd upon issuance of tlinlicense.
)
Ds@Embh Wstinig liisisE,WisssbSiiilliuSsiiMEMfunifiA06IriiisiiMMiity Manageiniitt. program hits been inipiemcoted,iand'slisil malaithi^qualitimanagimint pro j
Ifailable foFreview[during the nitittlididdmeht requdli$nsejrenewal, brI=--Abt!Un,yhicheve occurs;fint.]
See FrMG 17 - Records Notifications and Renorts ofMiudminieratinns a.
For a misadministration:
i.
The licensee shall notify the Agency by telephone no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery of 4
the misadministration; 1
l ii.
The licensee shall submit a written report to the Agency within 15 days after discovery of the misadministration. The written report must include the licensee's name; the prescribing physicians's name; a briefdescription of the event; why the event occurred; the effect on the patient or human research subject; what improvements are needed to prevent i
recurrence; actions taken to p event recurrence; whether the licensee notified the patient I
~
or human research' subject, or the patient's or human research subject's responsible relative
{
j or guardian (this person will be subsequently referred to as "the patient"), and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to j
identification of the patient; iii.
The licensee shall notify the referring physician and also notify the patient EEuman research subject of the misadministration not later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, unless the referring physician personally informs the licensee either that he or she will inform the patientfor human resdarch'iUbject or that, based on medicaljudgement, telling the patient or human research. subject would be harmful. The licensee is not required to notify the patient or buman research subject without first consulting the referring physician. If the referring physician or patient or humadresearch subj$6t cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the patient or human researchisubject as soon as possible thereafter. The licensee may not delay any appropriate medical care for the patient or human research subject, including any necessary remedial care as a result of the misadministration, becsuse of any delay in notification; GIS
SSRCR l'olume!-Draft. March 1997 Sec. G. t 7 0.10 iv.
If the patient ofl6IsnEsiifaisuidecs was notified, the licensee shall also furnish, within 15 days after discovery of the misadministration, a written report to the patient of human research%bjid by sending either:
~
(i)
A copy of the report that was submitted to the Agency; or 1
(ii)
A brief description of both the event and the consequences, as they may affect the patient or i
human researchipubject, provided a stateme.nt is included that the report submitted to the Agency can be obtained from the licensee.
b.
Each licensee shall retain a record of each misadministration for 5 years. The record shall contam
{
the names of all individuals involved (including the prescribing physician, allied health personnel, j
the patient or humin resiarsh"subjed, and the patient's 'or hUmari researchsbjids referring i
physician), the patient's of humanyesearc6[sdbjhti social security number or identification number if one has been assigned, a brief description of the misadministration, why it occurred, the effect on the patient or humait research'nbject, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.
l Aside from the notification requirement, nothing in 6-14a-G 17a. and fr-14tnGl17til shall affect c.
any rights or duties oflicensees and physicians in relation to each other, patients or human research subjects, or the patient's or hunsan research subject's responsible relatives or guardians.
Sec 6-MG 18 - Sunnliers A licensee shall use for medical use only:
Radioactive matenal manufactured, produced, labeled, prepared, compounded, packaged, and a.
distributed in accordance with a license issued pursuant to these regulations or the equivalent regulations of another Agreement State, a Licensing State or the Nuclear Regulatory Commission; and b.
Reagent kits, radiopharmaceuticals, and/or radiobiologies that have been manufactured, labeled, packaged, and distributed in accordance with an approval issued by the Food and Drug Administration; or Radiopharmaceuticals compounded from a prescription in accordance with the regulations of the c.
state Board of Pharmacy.
d.
Teletherapy and brachytherapy sources manufactured and distributed in accordance with a license issued pursuant to these regulations, or the equivalent regulations of another Agreement State, a Licensing State, or the Nuclear Regulatory Commission.
Specific Requirements
[See G+5G.19 - Ouality Control of Diagnostic Eouipment Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies. As a minimum, quality control procedures and frequencies shall be those recommended by equipment manufacturers or G16
l sec. o.10 i
ssnca valuar1-Draft. March 1997 procedures which have been approved by the Agency. The licensee shall conduct quality control procedures in accordance with written procedures.]
j Sec G+7G50 - Ponemanion Use. Calibration and Charle ofDone Calihrators A medical use licensee authorized to admihister radiopharmaceuticals shall possess a dose a.
calibrator and use it to measure the amount of activity administered to each patient kiEduin i
jisAuihissbjict. In the case where the ionization type dose calibrator cannot be used eff to verify administered activity, the licensee shall use an alternative method. Any alternative method to the use of a dose calibrator shall be approved by the Agency in writing. Any alternative method shall provide for acceptable verification of constancy, accuracy, linearity, and j
geometry dependence as applicable.
b.
Each licensee shall establish written quality control procedures for all dose calibrators used for measuring the amount of activity administered to a patient iiii butnan EeAarchMbjoit. As a minimum, quality control procedures and frequencies shall be those recommended by the -
{
American National Standards Institute in ANSI N42.13-1986 [or the licensee shall:
4 i.
Check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use. The check shall be done on a frequently used setting with a sealed source of not less than 1.85 megabecquerels (50 pCi) of any photon-emitting radionuclide i
}
with a half-life greater than 90 days; i
ii.
. Test each dose calibrator for accuracy upon installation and at intervals not to exceed 12 months thereafter by assaying at least 2 sealed sources containing different radionuclides with activities of at least 1.85 megabecquerels (50 pCi) each. The activity of one source i
shall be determined by the manufacturer to be within 5 percent of the stated activity. All other sources used for this test shall be within 10 percent of the stated activity. All 4
i sources used to satisfy the accuracy test shall be calibration sources traceable to the National Institute of Standards and Technology or oti.er standards recognized as being l
equivalent by the National Institute of Standards and Technology; e
iii.
Test each dose calibrator for linearity upon installation and at intervals not to exceed 3 L
months thereafter over the range of use Liw 370 ;divo.woede 00 pC;) ed ik~
j hrghest Jv e ilme;;; 6.
g,[thAjose calibra6fshall. be[cosspicuouslyposted with j
the range Eve / which the linearity was" performed;] and 4
4
- iv.
Test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. The licensee shall keep a record of this test for the duration of the use of the dose calibrator.
A licensee shall mathematical!y correct dosage readings for any geometry er linearity error that 1
c.
(
exceeds 10 percent if the dosage is greater than 370 i;;v6wom J Lumeshecquehls (te 30 pCi) and shall repair or replace the dose calibrator if the accuracy or constancy error exceeds 10 percent.
2 1
3 G17 I
.m _ _ _. _ _ _
SSRCR ltlumei.Drqtt, Mech JM7
%. G.20 0.2 t d.
A licensee shall also perform checks and tests required by Er.-hHrGjok following adjustme repair of the dose calibrator.
i I
A licensee shall retain a record of each check and test required by 6490 0 for 3 years. The e.
records required by 6+MrG.20b; shall include:
1 i.
For C. 7..;D.206%, the model and serial number of the dose calibrator, the identity calibrated activity of the radionuclide contained in the check source, the date of the chec j
j
- the activity measured, the instrument settings, and the initials of the individual who pedormed the check; 1
ii.
For O.17...;.D5061, the model and serial number of the dose calibrator, the model and
}.
serial number of each source used and the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, the instrument settings, and the signature of the individual who pedormed the test; iii.
For 0.;7..;,;.G.30Elii., the model and serial number of the dose calibrator, the calculated activities, the measured activities, the date of the test, and the signature of the individual
}
who performed thitest; and i
.iv.
For 0. ;7.n.Gjob'ii, the model and serial number of the dose calibrator, tiie configuration and calibrated activity of the source measured, the activity of the source, the i
i activity measured and the instrument setting for each volume measured, the date of the
}
test, and the signature of the individual who performed the test).
1 i
See G-+9G M - Calibration and Check of Survev Instruments i
n.
A licensee shall ensure that the survey instruments used to show compliance with Pan G have j
been calibrated before first use, annually, and following repair.
4 l
b.
To satisfy the requirements of 646rGi1M, the licensic : hall:
l i.
Calibrate all required scale readings up to 10 millisieverts (1000 mrem) per hour with a I
1, radiation source; ii.
For each scale that shall be calibrated, calibrate 2 readings separated by at least 50 percent of scale rating; and iii.
Conspicuously note on the instrument the apparent dose rate from a dedicated check
{-
source as determined at the time of calibration, and the date of calibration.
e To satisfy the requirements of 6.fetrG.21b;, the licensee shall consider a point as calibrated if the c.
indicated exposure rate differs from the calculated exposure rate by not more than 10 percent; and j
consider a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent if a correction chart or graph is conspicuously attached to the j
instmment.
k
)
G18 p
h
,,o Sec. G.81 - G.23 SSRCR Volume 1 Draft, March 1997 d.
A licensee shall check each,cvey' instrument for proper operation with the dedicated check source before each use. The licensee is not required to keep records of these checks.
The licensee shall retain a record of each calibration required in G4en-Gjli! for 3 years. The 4.
record shallinclude:
i.
A description of the calibration procedure; and ii.
A description of the source used and the cenified dose rates from the source, and the rates indicated by the instrument being calibrated, the correction factors deduced from the calibration data, the signature of the individual who performed the calibration, and the date of calibration.-
f.
To meet the requirements of 649afrils., b., and c., the licensee may obtain the services of individuals licensed by the Agency, the Nuclear Regulatory Commission, an Agreement State, or a Licensing State to perform calibrations of survey instruments. Records of calibrations which contain information required by 649e-G.21e. sha!! be maintained by the licensee.
Sec &+9G N - Assnv of Tadiceharmaceutical Dosanes Alicensee shall:
Assay, [within 30 minutes] before medical use, the activity of each radiopharmaceutical dosage a.
that contains more than 370 'Abw.s1.11 tnegabequstels (f930 pCi) of a photon-emitting e
i radionuclide; b.
Assay, before medical use, the activity of each radiopharmaceutical dosage emitting alpha and/or beta radiation as the radiation of principal interest, unless such radiopharmaceutical has been obtained:
i In unit dose form, calibrated by the supplier for individual patients of human research subjects; and ii.
From a supplier which participates in a measurement quality assurance program with the National Institute of Standards and Technology, and which is designed to ensure that unit doses have a calibration traceable to a national standard; Retain a record of the assays or calibrations required by 649sfr.22a. and b. for 3 years. To c.
satisfy this requirement, the record shall contain the:
i.
radiopharmaceutical, or the radionuclide administered.
ii.
Patient's 6r human reseaich"subjict's name, and identification number if one has been assigned; iii.
Prescribed dosage and measured activity of the dosage at the time of assay, or a notation that the total activity was determined by a calibration traceable to a national standard; iv.
Date and time of the assay or calibration and the date and time of the administration; and Gl9
SSRCR VolumeI-Draft. March 1997 Sec. G.23 - G.24 Initials of the individual who performed the assay or documentation of the supplier's v.
participation in the measurement quality assurance program specified in 6-196G.21b.
See G-?OG 23 - Authorintion for Calibration and Reference Sources Any person authorized by C.3G:5 for medical use of radioactive material may receive, possess, and use the following rad material for check, calibration and reference use:.
j a.
Scaled sources manufactured and distributed by persons specifically licensed pursuant to Part C o these regulations or equivalent provisions of the Nuclear Regulatory Commission, Agreement State or Licensing State and that do not exceed 555 megabecquerels (15 mci) each; b.
Any radioactive material [ listed in C.3
- v. C.33G;343r'.G.36] with a half-life of 100 days or less in individual amounts not to exceed 555 megabecquerels (15 mci);
Any radioactive material [ listed ir. C.:i v. C.33 G.34 oFG.36] with a half-life greater than 100 c.
days in individual amounts not to exceed 7.4 megabecquerels (200 pCi) each; and d.
Technetium-99m in individual amounts not to exceed 1.85 gigabecquerels (50 mci).
Sec GMG 24 - Recuirernents for Possession of Sealed Sources and Brachythernov Sourcet A licensee in possession of any sealed source or brachytherapy source shall follow the radiation 4
a.
safety and handling instructions supplied by the manufacturer or equivalent instructions approved by the Agency and shall maintain the instmetions for the duration of source use in a legible form convenient to users.
b.
A licensee in possession of a sealed source shall assure that:
i.
The source is tested for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within 6 months before transfer to the licensee; and ii.
The source is tested for leakage at intervals not to exceed 6 months or at intervals approved by the Agency, another Agreement State, a Licensing State or the Nuclear Regulatory Commission.
To satisfy the leak test requirements of 6hG.24b., the licensee shall assure that:
c.
i.
Leak tests are capable of detecting the presence of 185 becquerels (0.005 pCi) of radioactive material on the test sample, or in the case of radium, the escape of radon at the rate of 37 becquerels (0.001 pCi) per 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />; ii.
Test samples are taken from the source or from the surfaces of the device in which the source is mounted or stored on which radioactive contamination might be expected to accumulate; and iii.
Test samples are taken when the device containing the source is in the "off' position.
G20
.*?
\\
l Sec. 0.24 - G.25 SSRCR Volume 1 Drop March 1997 d.
A licensee shall retain leak test reciords for 5 years. The records shall contain the and serial number, if assigned, of each source tested, the identity of each source radionucl l
its estimated activity, the measured activity of each test sample expressed in becq i
description of the method used to measure each test sample, the date ofthe test, an of the individual who performed the test.-
i If the leak test reveals the presence of 185 becquerels (0.005 pCi) or more ofremovable e.
contamination, the licensee shall:
i.
Immediately withdraw the sealed source from use and store, repair or dispose ofit in accordance with the requirements ofPart D ofthese regulations; and i
ii.
File a report with the Agency within 5 days of receiving the leak test results with the Agency describing the equipment involved, the test results, and the action taken.
i f.
A licensee need not perform a leak t:st on the following sources:
4 j
i.
Sources containing only radioactive material with a half-life ofless than 30 days; l
ii.
Sources containing only radioactive material as a gas; 4
iii.
Sources containing 3.7 megabecquerels (100 pCi) or less of beta-or photon-emitting i
material or 370 kilobecquerels (10 pCi) or less of alpha-emitting material; [and]
l iv.
Seeds ofiridium-192 encased in nylon ribbon [; and Sources stored and not being used. The licensee shall, however, test each such source for v.
leakage before any use or transfer unless it has been tested for leakage within 6 months before the date ofut,e or transfer).
A licensee in possession of a sealed source or brachytherapy source shall conduct a physical g.
inventory of all such sources at intervals not to exceed 3 months. The licensee shall retain each inventory record for 5 years. The inventory records shall contain the model number of each
~
source, and serial number if one has been assigned, the identity of each source radionuclide and its estimated activity, the location of each source, date of the inventory, and the signature of the individual who performed the inventory.
i h.
A licensee in possession of a sealed source or brachytherapy source shall survey with a radiation survey instrument at intervals not to exceed 3 months all areas where such sources are stored.
This does not apply to teletherapy sources in teletherapy units or sealed sources in diagnostic devices.
i.
A licensee shall retain a record of each survey required in EHi%G.24h' for 3 years. The record
]
shall include the date of the survey, a sketch of each area that was surveyed, the measured dose rate at several points in each area expressed in microsievens (mrem) per hour, the model number i
and serial number of the survey instrument used to make the survey, and the signature of the j
individual who performed the survey.
G21
m_.
SSRCR VoluNe1-Drg/L March 1997 Sec. G.25 0.29 See G4WHs - Svrinne Shinide
=
A licensee shall keep syringes that contain radioactive material to be administered in an s.
appropriate radiation shield or shielded area.
i b.
A licensee shall require each individual who prepares or administers radiopharmaceuticals to an appropriate syringe radiation shield unless the use of the shield is contraindicated for that patient or human riseki:bliubini 4
See G-MG 26 - Svrinne i nhein Unless utilized immediately, a licensee shall conspicuously id
{
~
each syringe, or syringe radiation shield as to contents or intended patient dhumah5ssichishbjk See G44G 57 - Vial Shielde A licensee :, hall require each individual preparing or handling a vial that y
contains a radiopharmaceutical to keen the vial in a vial radiation shield.
L
{
See G-MG 2R - Vin! Shield Y,ahnlL A licensee shall conspicuously label each vial radiation shield that contains a vial of a radiopharnaceutical with the radiopharmaceutical name or its abbreviation.
Sec 646Gl29 - Surveys for Ambient Rad! iian Dose Rate and Contamination A licensee shall survey with a radiation detection survey instrument at the end of each day of use a.
all areas where radiopharmaceuticals are prepared for use or administered.
b.
A licensee shall survey with a radiation detection survey instrument at least once each week all l
areas where radiopharmaceuticals or radioactive wastes are stored.
A licensee shall conduct the surveys required by 646rGl29a2 and b. so as to able to measure I
c.
dose rates as low as I microsievert (0.1 mrem) per hour.
i j
d.
A licensee shall establish dose rate action 1-vels for the surveys required by 6-26rG.29a. and b.
i j
and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if a dose rate exceeds an action level, A licensee shall survey for removable contamination each day of use all areas where j
e.
i radiopharmaceuticals are prepared for use or administered and each week where radioactive materials are stored.
f.
A licensee shall conduct the surveys required by 646eG29E so as to be able to detect j
contamination on each wipe sample of 33.3 becquerels (2000 dpm).
- g. '
A licensee shall establish removable contamination action levels for the surveys required by 646e-G.'29E and shall require that the individual performing the survey immediately notify the Radiation Safety Officer if contamination exceeds action levels.
h.
A licensee shall retain a record of each survey required by 646 aft.29a', b., and e. for 3 years.
The record must include the date of the survey, a sketch ofeach area surveyed, action levels established for each area, the measured dose rate at several points in each area expressed in G22 s- -... -
m-,
]
.~
i I
Sec.G.31.G.30 SSRCR Volume 1-Drqft. March 1997
):
microsieverts (mrem) per hour or the removable contamination in each area expressed in becquerels (dpm) per 100 square centimeters, the serial number and the model number of th instrument used to make the survey or analyze the samples, and the initials of the individua
.i performed the survey, >
l See FrMG10 - Relente of"A..M4idn..ie Containino Radionharmarauticale or N.
m 1
Imnlante v
i..
a.
. u
.i.
n =
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E < L The licensee may authorize thirilease from iisls56tf6f6(EtFindiNdsIMhdlias 6esn administered radiopharmaceuticals or permansat er temp 6ifary implantiboikalning radioactive
~
material if the total hffectivs dose equivalent to an'other individual front exposure td,the released individual is nodiksly to..excesd 5 millisieverts (0.5 rem),!
6l.
. Thilicensee shall provide thireleased individulind wherE appropriate,Windividbilifamily, with oral and written instructions, on actions recommended to maintain ~ doses to; Lo'her t
l individuals as low as is reasonably' achievable if the total' effective dose.equivalendo any other i
individual is likelyto exceed I millisievert.(0.1 NmfIf ths d6se ' o a' breast-fehlinginfant'or child
~
~
t i
could. exceed 1 millisievert'(0.1[ rem)~assuminithere were no. int'emiptioisfbreast-feedirig,'the y
mstructions shall alsoincludei 1
.- z.,
del. '.. ~,Aguidaru:e orithiin.terruption or,s s
d,sco..,nnnuation o..f bre,ast-feeding, 'and o -.
i
,.s Va^.+./
gg.
. im
- ation on'the co_.<..sns'equences.of failur.Adf.,e to follo.,p.....
l WW J u.
"y.g, form. h,....g
._.6.
....n
.-N;.
...4..L s.
w th...s..., idanc. %e.
w e gu n.,
m...
.......1
...... c
......~..y.
..m..
y m... m enk The licens,ee shall m., s.amtain a record of the bass,,for au..,honzm, g.r...,
the... lea,se of an indiv,d,a. l, for,,..3 t
re iu years after the !date 6frelease, if the total effectis dose eqidvalent.is calcslated byi 4
e.... -
.< usins the retained ne,.tivity ratherthan thinc,......,.y.,tivity adminisier,ed,.
U E i, Z,#
.y..
.....v.
J
- n p w...sii;. Tusing an 5 occupancy factorless tiiaf..n 0.25 at 1 meter,:
1
..v..
7,
...m
.,.4 b,.iii. 's.using the biological or effective half-life;or i
'iv. ' iconsidering the'shididing by tissue.
A 1
G23 1
MRCR l'oheme1-Drqft. March 1997 i
see.o.31.o.33 i
3375The MMdsi!}nsisiG[Irsc&difdWfiarsiftefthEdsT6f klesk,"thMjdsE6ctIdss~were Provided.WibrainstJeedirig' woman"ifhis radiatidislosi6hiefiant or child fr6sticostinued l
breast-feeding could roulti4 tot Ilefrediveijosefeguivalekexcee' ing 1.'millisievert10.T rem)';
d i
i Sec 649G 31 - Mobile NnAame Medicine Service Technieml Renuir=mta A licensee providing i
mobile nuclear medicine service shall:
- i l
Transpon to each address ofuse only syringes or vials containing prepared radiopharmaceuticals a.
j or radiopharmaceuticals that are intended for reconstitution of radiopharmaceutical kits; I
b.
Bring into each area of use all radioactive material to be used and, before leaving, remove all i
unused radioactive material and associated radioactive waste; c.
Secure or keep under constant surveillance and immediate control all radioactive material when in j
transit or at an area ofuse; d.
In addition to complying with frWG.20 and 649G.21, check survey instruments and dose i
calibrators for constancy and response, and check all other transported equipment for proper j
function before medical use at each area of use; 4
Carry a survey meter calibrated in accordance with 649G.21 in each vehicle that is being used to l
e.
transport radioactive material, and, before leaving a client area ofuse, survey all areas of i
radiopharmaceutical use with a radiation detection survey instrument, including a survey for removable contamination, to ensure that all radiopharmaceuticals and all associated radioactive waste have been removed; f.
Retain a record of each survey required by 6-99e G31e. for 3 years. The record must include the 1
date of the survey, a plan of each area that was surveyed, the measured dose rate at several points 4
in each area of use expressed in microsievens (mrem) per hour, the removable contamination in i
cach area expressed in becquerels (dpm) per 100 square centimeters, the model and serial number i
of the instrument used to make the survey, and the initials of the individual who performed the survey; and i
g.
Use radioactive gases only in areas of use and under conditions which have been evaluated and approved by the Agency for compliance with airborne release standards.
See G49G 32 - Storage of Volatilen and G=we a.
A licensee shall store volatile radiopharmaceuticals and radioactive gases in the shippers' radiation i
shield and container.
4 b.
A licensee shaF store and use a multidose container in a properly functioning fume hood.
l See G46G 33 - Decav-In-Stornye 4
4 4
e G24
-.. ~ --
[ {g.
t I^
Sec. 0.31 - G.30 t
SSRCR Shne1 Drqtt, March 1997 l
f a.
Before disposal in ordbn trash, "a licensee shall hold radioactive material for decay-in i
{
and is exempt from the waste disposal requirements of Part D of these regulations if the licensee:
i i,
i.
Holds radioactive material for decay a minimum of 10 half-lives; li.
Monitors radioactive material at the container surface before disposal as ordinary trash 1
and determines that its radioactivity cannot be distinguished from the background i
radiation level with an appropriate radiation detection survey instrument set on its most mensitive scale and with no interposed shielding; i
l iii.
Removes or obliterates all radiat;on labels; and
[
' iv.'
Separates and monitors each generator column individually with all radiation saielding removed to ensure that its contents have decayed to background radiation levd_ before 1
j disposal.
1 4
l' b.
For radioactive material disposed in accordance with fiHH>rG.33a., the licensee shall retain a l
record of each diaaosal for 3 years. The record must include the date of the disposal, the date'on which the radioactive material was placed in storage, the radionuclides disposed, the model and serial number of the survey instrument used, the background dose rate, '.he radiation dose rate i
measured at the surface of each wr.ste container, and the name of the individual who performed
[
the disposal.
i 1
a 1
l
' Specific Requirements for the Use of Radiopharmaceuticals for 4
Uptake, Dilution, or Escretion Studies
.l 1
[
' Rec Fr4+G T4 - Une ofRmAinnharmaceutiem1= for Untake Dilution or EucMnn Studiec
.4c A licensee may use u.y s..m.....u.
o o. -
u...==:=y.-=== =u -.... 2 4
[
.ui-+=..... of oyi.k., O o;vo, v..
...uvo.
.....u.........
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w... u... n oo....o.u vu, v.
4 v-
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.. _ i.o===.=-.u..____......u vu
- v....... --- o v.
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i u,
j foIspIaki,"dilutionTor iissati6n 'studiesimysdioidiW iisistiallpreisafiidlfor' nindicalluse that is eith'er:
~
- c. & Ob, tamed fr,om, m.a manufacturer or preparer h,ce._d..,,nse pursuant to thes_e regul,atioris o
. ~.. _
..m._
regulations of the NRC, an Asieement Staie ofa Licensirig State; or i
2' g
G25
SSRCR l'olume!- Dr-ft, March 1997 Sec 0.31 0.33
~
b.Z~ Prepared by asiuth&ized 'mmlear phiiin cist,Tph'ysicianWis an authorized useisnd aho meets the requirementi specified in G.71,' or an individual under the superWsion;of either an authorized nuclear pharmacist or an authorized user as specified in G.12.
Sec 6-MG 35 - Ponwanton of Survev Inctmment A licensee authorized to use radioactive material uptake, dilution, and excretion studies shall possess a portable radiation detection survey instrument I
capable of detecting dose rates over the range 1 microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour. The instrument shall be operable and calibrated in accordance with 6-19G.21.
Specific Requirements for the Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies Sec 6-MG 36 - Use of Radionharmaceuticah Generators and Rennent Kits for Immoino and Localization Studies i
a.1 A licensee may use any radioactive matenalin a diagnostic radiopharmaceutical(except aerosol or gaseous forms) or any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material-YS h h Lea b u n giouisd es w yianss 0 ayyav..I by iLs TOOd end Diug-Aduuulaii i en, Oi e.
b.
Vaah Los Lmu prey.d end evo.younded in ewvid.uce,,dh d s reguiei vu of the,i. e Deerd vf Th
- umy,
- i. -
[Obtained tiom a manufacturer or preparer licen' sed pursuant to'these regulations _ or equivalent regulations of the NRC, an Agreement State or a Licensmg Siste;or
.ii.:
Prepared by an authorized nuclear pharmacistia physician who is an authorized user and who meets the requirements specified in G.71, or an individual'under'the supenision c,f either an authorized ' nuclear pharmacist or an authorized user as _specified in G.12.
e-b-A licensee shall clute generators in compliance with 6-34G.37; d.
Provided the conditions of 6-MG.38 are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Agency.
See G-MG 37 - Radionuclide Contaminants a.
A licensee shall not administer a radiopharmaceutical containing:
i.
More than 0-M 5.55 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 pCi of Mo-99 per mci of Tc-99m);
ii.
More than efr2 0.74 kilc, becquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 pCi of Sr-82 per mci of Rb-82 chloride);
G26 l
t
c_
_m 4
Sec. O.33. G.35 SSRCR Volume 1 Drqft. March 1997 i
i iii.
More than 92 73 kilobecquerel of strontium-85 per megabecquerel ofrubidium-82 chloride injection (0.2 pCi of 5r-85 per mci ofRb-82 ' chloride).
b.
A licensee preparing radiopharmaceuticals from radionuclide generators shall measure the concentration ofradionuclide contaminant in each eluate or extract, as appropriate for the generator system, to determine complisnce with the limits specified in 6-NsGj72.
I A licensee who must measure radionuclide contaminant concentration shall retain a re c.
i measurement for 3 years. The record shall include, for each elution or extraction tested, the i
measured activity of the radiopharmaceutical expressed in megabecquerels (mci), the measured i
activity of contaminant expressed in kilobecquerels (pCi), the ratio of the measures expressed as i
kilobecquerels (pCi) of contaminant per megabecquerel (mci) of radiopharmaceutical, the date of j
the test, and the initials of the individual who performed the test.
i I
d.
A licensee shall report immediately to the Agency each occurrence of radionuclide contaminant concentration exceeding the limits specified in 6-mag.37a.
l See G-MG 38 - Control of Aerosols and Gawc A licensee who administers radioactive aerosols or gases shall do so with a system that will keep a.
1 airborne concentrations within the limits prescribed in Pan D of these regulations.
q b,
The system shall [either be directly vented to the atmosphere through an air exhaust or] provide l
for collection and decay or disposal of the aerosol or gas in a shielded container.
~
A licensee shall only administer radioactive gases in rooms that are at negative pressure with i
c.
respect to surrounding rooms.
d.
Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit listed in Appendix B ofPan D of these regulations. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.
A licensee shall post the time calculated in 6-Md-G.38d' at the area ofuse and require that, in i
c.
j case of a gas spill, individuals evacuate the room until the posted time has elapsed.
i f.
A licensee shall check the operation ofcollection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed 6 months. Records of these checks and measurements shall be maintained for 3 years.
g.
. A copy of the calculations required in C.%iG.38d. shall be recorded and retained for the duration of the license.
Sec G-MG.39 - Possession of Survev Instrument ( A licensee authorized to use radioactive material for imaging and localization studies shall possess a ponable radiation detection survey instrument capable cf detecting dose rates cNer the range of I microsievert (0.1 mrem) per hour to 500 microsievens (50 mrems) per hour, and a ponable radiation measurement survey instrument capable of measuring dose G27
SSRCR VohawI DroAManh 1997 l
Sec. 0.40 0.41 l
rates over the range 10 microsieverts (1 mrem) per hour to 10 millisieverts (1000 mrems) per hour. T instruments shall be operable and calibrated in accordance with EriSG.21.
1 Specific Requirements for the Use of Radiopharmaceuticals for Therapy See FrMG 40 - Use of Radinnharmaceuticale for Theranv A licensee may use any radioactive materi in a radiopharmaceutical and for a therapeutic use:
"0.;c;. l L..u g. u.d -sy...c. v.yyi..: by i: T vd..d 0. AA bJ=..uvu
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- d. il.
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G f0btained frosn a mahufabtifs"or pre @klicensedidsdas to ilEsEIeiblations jr equivalent regulations of the NRC, anl Agreement State lor a Licensing State; or i
G ? Pdpsed by an authorized nuclear pharmacist 7a' physician %hdis an authbrized'uneiMd we meets the requirements specified in G.71, or an individual underthe' supervision.of either an authorized nuclear pharmacist or an authorized user as specified in G.12.'
~
See frMG 41 - Safety Instmetinn A licensee shall provide oral and written radiation safety instruction for all personnel caring for a.
patients or human research subjects undergoing radiopharmaceutical therapy. Refresher training shall be provided at intervals not to exceed 1 year.
b.
To satisfy 69 erg 41a., the instruction shall describe the licensee's procedures for:
i.
Patient ' r human resiarch subject control; o
~
i ii.
Visitor contre!:
lii.
Contamination control; iv.
Waste control; Notification of the Radiation Safety Officer or authorized user in case of the patient's or v.
hiunan~research subject's death or medical emergency; and vi.
Training for workers as required by Part J of these regulations.
A licensee shall keep a record ofindividuals receiving instmetion required by 69thrGAlik a c.
description of the instruction, the date ofinstruction, and the name of the individual who gave the instruction.. Such record shall be maintained for inspection by the Agency for 3 years.
Sec. 649G 42 - Safety Precautions
~
G28
j a.
y
'Sec. 0.43 G.42 SSRCR Vohome1 Draft. March 1997 I
For each patient iiiGiiiii5iIOidistsiiit receiving radiopharmaceutical therapy and a.
[.
hospitalized for compliance with 619Gl.30, a licensee shall:
)
i i.
Provide a private room with a private sanitary facility, ii.
Pwt the patient's siinsiisiiiiiiiii h"liiabisW door with a " Caution: Radioactive
'. Material" sign and note on'the door or on the patient's dM6ianYGiischidbjeht's chart b
vehere and how long visitors may stay in the patient's kWmeh researchi"mabject/s room; l
iii.
Authorize visits by individuals under 18 years of age only on a case-by-case brcis with the approval of the authorized user after consultation with the Radiation Safety Officer; 3_
i l'
iv.
Promptly after administration of the dosage, measure the dose rates in contiguous j
restricted and unrestricted areas with a radiation measurem.mt survey instrument to
[
demonstrate compliance with the requirements of Part D of these regulations and retain l
for 3 years a record of each survey that includes the time and date of the survey, a plan of j
the area or list of points surveyed, the measured dose rate at several points expressed in i
microsieverts (mrem) per hour, the instrument used to make the survey, and the in61s of j
the individual who made the survey; j
Either monitor material and items removed from the patient's or b'umaniresenich siubject's v.
room to determine that any contamination cannot be distinguished from the natural I
background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle these materials and items as
[
radioactive waste; 8
3, vi.
......,....y.....,.......yy.y.....,....y..........,,...,.m-...m.
i.d$.i.v.. a ' iy yisw.wi O..a i!.ai w... y iO 'nshy i.dA.i v.. dva iO.hua ~!d whnbs..',
m. m.... ~ ~ m. y.m..'.
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.t t i
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. v.
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3....... v. m.
i
- y...m, L
e vii.
Survey the patient's or hum...- m.an research sui $ect's room and private sanitary facility for
[
removable contamination with a radiation detection survey instrument before assigr.ing F
another patient or human research asbject to the room. The room must not be reassigned until removable contamination is less than 3.33 becquerels (200 dpm) per 100 square L
centimeters; and i
l vivivii. Measure the thyroid burden of each individual who helped prepare or administer a dosage i
ofl-131 within 3 days after administering the dosage, and retain for the period required by F
Part D of these regulations a record of each thyroid burden measurement, date of
[
measurement, the name of the individual whose thyroid burden was measured, and the initials of the individual who made the measurements. Other procedures acceptable to the i
4 Agency may be used for individuals who only prepare, but do not administer, doses of stabilized I-131.
4 1
4 h h.b.5bh...hD.kh h y.k.E..k. 54d T.k.h.. Oy......bbhb.k.bb. k..yJ, k.....bs. 3.,
3...I.. N 63 e
- e., m..,...,.......y y..y....,.. -. v...mm........,,m...,......m....mm....m......~..
1 G29 4-
j-SSRCA l'ohaneI.Drg/t, March /M7 Sec. O 44 - 0 48 i-
'.y p
=:--- ;;
y ~by..J;..m.. Jo. ~ ;6 lm=lm;J... 6m -.J ;.. y.;&.
- ~ - -. -. m y l
The Radiation Safety Officer or the authorized user shall be notified immediately if the c.
hospitalized patient s hundredsrch subject dies or has a medical emergency.
4 w edeG 45 - pe m.6n orervey in tru==:=
A licensee authorized to use radioactive material for radiopharmaceutical therapy shall possess a ponatle radiation detection survey instrument capable of detecting dose rates over the range 1 microsieven (0.1 mrem) per hour to 500 microsievens (50 mrems) per hour, and a portable radiation measurement survey instrument capable ofmeasuring dose rates over the range 10 microsievens (1 mrem) per hour to 10 millisievens (1000.mrems) per hour. The instruments shall be operable and c.librated in accordance with 649-G.21;:
l i
Specific Requirements for the Use of Scaled Sources for Diagnosis 5
l sec G4+G 44 - Use of s. t.d Sources for Dimonnais A licensee shall use the following sealed sources i
in accordance with the manufacturer's radiation safety and handling instructions:
i i
Iodine-125 as a sealed source in a device for bone mineral analysis; a.
)
b.
Americium-241 as a :caled source in a device for bone mineral analysis; Gadolinium-153 as a sealed source in a device for bone mineral analysis or in a ponable device for j
c.
j imaging; and l
d.
Iodine-125 as a scaled source in a ponable device for imaging.
i Sec G49G 45 - Availmhility of Survev Instrument A licensee authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use a portable radiation detection survey instrument capable of detecting dose rates over the range 1 microsieven (0.1 mrem) per hour to 500
]
microsievens (50 mrems) per hour or a ponable radiation measurement survey instrument capable of measuring dose rates over the range 10 microsievens (1 mrem) per hour to 10 microsievens (1000 mrems) per hour. The instrument shall be operable and calibrated in accordance with 6-14-G.2K Specific Requireraents for the Use of Sources for Brachytherapy sec G49G '45 - Use of sources for Brachvtherany A licensee shall use the following sources in accordance with the manufacturer's radiation safety and handling instructions:
Cesium-137 as a scaled source in needles and applicator cells for topical, interstitial, and a.
intracavitary treatment of cancer; b.
Cobalt-60 as a scaled source in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer; G30 i
j
1 4
Sec. 0.47 0.48 SSRCR Volumel-Draft. March 1997 4
Gold-198 as's scaled source in seeds for interstitial treatment of cancer; c.
d.
Iodine-125 as a sealed source in seeds for interstitial treatment of cancer; Iridium 192 as seeds encased in nylon ribbon for interstitial treatment of cancer, e.
i f.
Strontium-90 as a scaled source in an applicator for treatment of superficial eye conditions; and i
g.
Palladium-103 as a sealed source in seeds for the interstitial treatment of cancer.'
he G44d 47. Enfety inetructinn 1
The licensee shall provide oral and written radiation safety instruction to all personnel caring for a a.
patient or b0 man'rsiearchlubject receiving implant therapy. Refresher training shall be provided
{
at intervals not to exceed 1 year.
i b.
To satisfy &44 r647A., the instruction shall describe:
i.
Size and appearance of the brachytherapy sources; ii.
Safe handling and shielding instructions in case of a dislodged source; Procedures for patient "i h6 man researchiubject control; iii.
o
)
iv.
Procedures for visitor control; Procedures for notification of the Radiation Safety Officer or authorized user if the patient v.
' r human research subjects dies or has a medical emergency; and o
vi.
Training for workers as required by Part J of these regulations.
A licensee shall maintain a record ofindividuals receiving instruction required by &44a-G.47a., a c.
description of the instruction, the date ofinstruction, and the name of the individual who gave the instruction for 3 years.
Sec &+5GMij - Safety Precautions-For each patient or haman research sbbject receiving implant therapy a licensee shall:
a.
i.
Not place the patient Bi human ^researcisuSeit in the same room with a patient brLhtiman Nsearch habject who is not receiving radiation therapy unless the licensee can demonstrate compliance with the radiation dose limits for individual members of the public as specified in Part D of these regulations at a distance of I metcr from the implant; ii.
Post the patient's 6r hGman ressaich" subject's door with a " Caution: Radioactive Materials" sign and note on the door or the patient's chart where and how long visitors may stay in the patient's or human research subject's room; G31
SSRCR Yolumeio Draft. Mars
- 199? -
Sec. G.4s. G.50 iii.
Aothorize visits by individuals under 18 years of age only on a case-by-case basis with the approval of the autho'rized user aAer consultation with the Radiation Safety Officer; and
' iv.
Promptly aAer implanting the sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with Part D of these regulations and retain for 3 years a record ofeach su that includes the time and date of the survey, a sketch of the area or list of points surveyed, the measured dose rate at several points expressed in microsieverts (mrems) p I._
hour, the instrument used to make the survey, and the initials of the individual who made the survey are Livie i.v.L:q i6 id== ere y=.,.do.:..:..
.d e y..o
.oi io.y., ;o.u.ci i6 y.o
.o,
.J 6...yy. vy....., iL y.J oJ. f_::,,
. :,..J io
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.od i6 y4;;.
- o
...L:,
- .;. 4..
i b.
The Radiation Safety Officer or authorized user shall be noti 6ed immediately if the hospitalized j
patient or human researchl subject d:es or has a medical emergency.
J j.
See G46GM - Brachvthernov Sources Inventnry i
1 a.
Each time brachytherapy sources ate returned to an area of storage from an area of use, the licensee shallimmediately count or otherwise verify the number retumed to ensure that all sources taken from the storage area have been returned.
b.
A licensee shall make a record of brachytherapy source utilization which includes:
i:
The names of the individuals permitted to handle the sources; ii.
The number and activity of sources removed from storage, the room number ofuse and patient's or idman'reseadh'subjec' 's name, the time and date they were removed from t
storage, the number and activity of sources in storage aAer the removal, and the initials of the individual who removed the sources from storage; and iii.-
The number and activity of sources returned to storage, the room number ofuse and patient's or human rekaich subject's name, the time and date they were returned to storage, the number and activity of sources in storage mRer the return, and the initials of the individual who returned the sources to storage.
Immediately aRer implanting sources in a patient id1Eir^ndTesiEifdQMi and immediately aRer c.
removal of sources from a patient or humaheM&cksubjeci, the licensee shall make a radiation survey of the patient 'or hhman reicar' ch} subject and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey.
d.
A licensee shall maintain the records required in C.0L.G.49b2 and c. for 3 years.
G32
Sec. 0.5 l. 0.55 SSRCR Vslume 1-Draft, March 1997 See fr49G M - Relemaa ofPatient; T,J ""fdnES RE'" Zi f Sd6iSE d i G E L al i f Tsr.aorary Imniants Immediately after removing the last temporary implant source from a patient 6Ir human ~resear~ch a.
subject, the licensee shall perform a radiation survey of the patient or burnaniesearch'subje'et with a indiation detection survey instrument to ' confirm that all sources have been removed. The
-!;nu,,.,; :: uvi..:
, f.um ovurn.smsui Tv. mJ:.:
.. y usm i.e.id by.,myv.
y huy A m.i :. : wm woi h... b,,o..mv.J.
b.
A licensee shall maintain a record of patient 6f humaliresearchisubjeht surveys which demonstrate compliance with C.47..G.50a.' for 3 years. Each record shall include the date of the survey, name of the patient br human researchibject, the dose rate from the patient 6dism ch kbject expressed as microsievens (rnrems) per hour and ss measured within 1 meter from the patient, and the initials of the individual who made the survey.
See G46G S1 - Possession of Survev Instmments A licensee authorized to use radioactive material fer implant therapy shall possess a ponable radiation detection survey instrument capable of detecting dose rates over the range 1 microsieven (0.1 mrem) per hour to 500 microsievens (50 mrems) per hour, and a ponable radiation meastirement survey instmment capable of measuring dose rates over the range 10 microsievens (mrems) per homo 10 millisievens (1000 mrems) per hour. The instruments shall be cperable and calibrated in accordance with fr+9G.21.
Specific Requirements for the Use of a Scaled Source in Teletherapy Sec G49G.52 - Use of a Scaled Source in a Telethernov Unit. A licensee shall use cobalt-60 or cesium-137 as a scaled source in a teletherapy unit for medical use in accordance with the manufacturer's radiation safety and operating instructions.
See G%G 53 - Maintenance and Renair Restrictions Only a person specifically licensed by the Agency, the Nuclear Regulatory Commission, or an Agreement State to perform teletherapy unit maintenance and repair shall install, relocate, or remove a teletherapy sealed source or a teletherapy unit that contains a sealed source or maintain, adjust, or repair the source drawer, the shutter or other mechanism of a teletherapy unit that could expose the source, reduce the shielding around the source, or j
result in increased radiation levels.
See fr4+G 54 - Amendments In addition to the requirements specified in Cr 4G.6, a licensee shall apply for and receive a license amendment before:
i e
a.
Making any change in the treatment room shielding; b.
Making any chage in the location of the teletherapy unit within the treatment room; i
c.
Using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room; d.
Relocating the teletherapy ur.it; or G33
SSRCR l'olume1-DraA Alarch In1 see. o 55. o 5g l
Allowing an individual not listed on the licensee's license to perform the duties of the teleth) e.
physicist.
4 See G-6fG $5 - Enfety Instructinn.
A licensee shall conspicuously post writtep instructions at the teletherapy unit console. These a.
instructions shall inform the operator of:
i.
The procedure to be followed to ensure that only the patient ork:EiidMMkjectis
~
in the treatment room before turning the primary beam ofradiation "on" to begin a -
treatment or after a door interlock interruption; ii.
The procedure to be followed if the operator is unable to turn the primary beam of radiation "off with controls outside the treatment room or any other abnormal operation occurs; and e
iii.
The names and telephone numbers of the authorized users and Radiation Safety Officer to be immediately contacted if the teletherapy unit or console operates abnormally.
i i
b.
A licensee shall provide instruction in the topics identified in &52 G'55m. to all individuals who I
operate a teletherapy unit and shall provide appropriate refresher training to individuals at intervals not to exceed 1 year.
A licensee shall maintain a record ofindividuals receiving instruction required by &52b-G.55b., a c.
i description of the instruction, the date ofinstruction, and the name of the individual who gave the instruction for 3 years.
i Sec 634G.56 - Doors. Interlocks end Warninn Systemn A licensee shall control access to the teletherapy room by a door at each entrance.
a.
b.
A licensee shall equip each entrance to the teletherapy ' oom with an electrical interlock system r
that shall:
i.
Prevent the operator from turning the primary beam of radiation "on" unless each treatment room entrance door is closed; ii.
Turn the beam of radiation "off immediately when an entrance door is opened; and iii.
Prevent the primary beam of radiation from being turned "on" following an interlock interruption until all treatment room entrance doors are closed and the beam on-off controlis reset at the console.
A licensee shall equip each entrance to the teletherapy room with a conspicuously visible beam c.
condition indicator light.
G34 C
..~
..,s Sec. G.Ss. 0.60 SSRCR l'olumel. Draft, March 1997 h,. diHwa s7. p.
+.. or h,v., tem =r^
A licensee authorized to use radioactive material in a J teletherapy unit shall possess either a portable radiation detection survey instrument ca dose rates over the range I microsieven (0.1 mrem) per hour to 500 microsievens (50 mrems) i or a ponable radiation measurement survey instrument capable of measuring dose rates over the i
microsieverts (1 mrem) per hour to.10 microsieverts (1000 mrems) per hour. The instruments shall be operable and calibrated in accordance with 6-ftC21)
Rec G45GiB - R=Ation Manitorina Device A licensee shall have in each teletherapy room a permanent radiation monitor capable of a.
j continuously monitoring beam status.
i b.
Each radiation monitor shall be capable of providing visible notice of a teletherapy unit i
malfunction that results in an exposed or panially exposed source. The visible indicator of high radiation levels shall be observable by an individual entering the teletherspy room.
J Each radit tion monitor shall be equipped with a backup power supply separate from the power c.
supply to the teletherapy unit. This backup power supply may be a battery system.
l d.
A radiation monitor shall be checked with a dedicated check source for proper operation each da i
before the teletherapy unit is used for treatment of patients or human researchiubjects.
g j
i e.
A license; shall maintain a record of the check required by C.;;iD38d. for 3 years. The record shall incluae the date of the check, notation that the monitor indicates when the source is exposed, i j
and the initials of the individual who performed the check, e
f, if a radiation monitor is inoperable, the licensee shall require any individual entering the teletherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for any malfunction of f he source exposure mechanism. The instruraent or dosimeter shall be l
checked with e dedicated check source for proper operation at the beginning of each day of use.
The licenses M1 keep a record as described in G.55e.
}
g.
A licensee shall promptly repair or replace the radiation monitor ifit is inoperable.
i l
See G46G 59 - Viewino Svstem A licensee shall construct or equip each teletherapy room to permit
~
i j
continuous observation of the patient 6r laimaEresehch sdbjNt from the teletherapy unit console during irradiatien.
y see G49 60 - Dominwtrv Enuinment i
A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, a.
}
one of the following two conditions shall be met:
4
]
i.
The system shall have been calibrated by the National Institute of Standards and j
Technolog or by a calibration laboratory accredited by the American Association of F
Physicists m Medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration; or 3
i 1
G35 i
.i
. ~,
~.
l
{-
' S$RCR hlumel Drot,htarch JM7 sec.0.so.o.sg 2-ii.-
The system shall have been calibrated within the previous 4 years,18 to 30 months after
~ that calibration, the system shall have been intercompared at an intercomparison mee t
with another dosimetry system that was calibrated within the past 24 months by the National Institute of Standards and Technology or by a calibration laboratory accredited by the American Association ofPhysicists in Medicine.. The intercomparison meeting shall be sanctioned by a calibration laboratory or radiologic physics center sccredited by the American Association ofPhysicists in Medicine. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee shall not use the intercomparison result to hange the calibration factor. When intercomparing dosimetry systems to be used for c
calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source. When intercomparing dosimetry systems to be used for calibrating j.
cesium-137 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 '
[
source.
l j
b.
The licensee shall have available for use a dosimetry system for spot-check measurements. To meet this requirement, the system may be compared witi: a system that has been calibrated in i
t
- accordance with (M9:G.'60s. This comparison shall have.- been performed within the previous
[
year and after each servicing that may have affected system calibration. The spot-check system shall be the same system used to meet the requirement in frFr G.~60s -
a The licensee shall maintain a record of each calibration, intercomparison, and comparison for the c.
duration of the license. For each calibration, intercomparison, or comparison, the record shall j
include the date, the model numbers and serial numbers of the instruments that were calibrated,
[
intercompared, or compared as required by (H9rG.60a! and b., the correction factors that were j'-
determined, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration laboratory or radiologic physics center accredited by the American Association of Physicists in Medicine.
i j
See G t4G 6i - Full Calibration MemenrgmggtL 3
- A licensee authorized to use a teletherapy unit for medical use shall perform full calibration
]
a.
i measurements on each teletherapy unit:
- i.
Before the first medical use of the unit; ii.
' Before medical use under the following conditions:
(1)
Whenever spot-check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay; (2)
Following replacement of the source or following reinstallation of the teletherapy unit in a new location; and G36
ses.o.ss.o.s1 ssnca Iklune1-Drap. March 1997 (3)
Following r.ny repair of the teletherapy unit that includes removal of the source or j
major repair of the components associated with the source exposure assembly; and i
iii.
At intervals not exceeding 1 year.
- b.'
To satisfy the requirement offr59a O11I, full calibration measurements shall include i
~ determination of:
i i.
The output within 3 percent for the range offield sizes and for the distance or range of distances used for medical use; ii.
The coincidence of the radiation Seld and the field indicated by the light beam localizing device; iii.
The uniformity of the radiation field and its dependence on the orientation of the useful beam; iv.
Timer accuracy, constancy, and linearity; v.
"On-off" error, and vi.
The accuracy of all distance measuring and localization devices in medical use.
A licensee shall use the dosimetry system described in &59G.60 to measure the output for 1 set c.
~
of exposure conditions. The remaining radiation measurements required in C.'OL.;.G.61b.i. may then be made using a dosimetry system that indicates relative dose rates.
d.
A licensee shall make full calibration measurements required by &56a-G.61a in accordance with the measurements required for annual calibration by " Comprehensive QA for Radiation Oncology:
Report of AAPM Radiation Therapy Committee Task Group 40," Medical Physict Vol. 21, No.
4,1994, pp. 581-618.
A licensee shall e.orrect mathematically the outputs determined in C.';L.;.G.l6I' b'.i2 for physical e.
decay for intervals not exceeding 1 month for cobalt-60 and intervals not exceeding 6 months for cesium-137.
f.
Full calibration measurements required by &59rG.61al and physical decay corrections required by &56e G.611 shall be performed by a teletherapy physicist named on the licensee's license or authorized by a license issued by the Nuclear Regulatory Commission or an Agreement State to perform such services.
3 A licensee shall maintain a record of each calibration for the duration of the license. The record shall include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit and the source, the model numbers and serial numbers of the
. instruments used to calibrate the teletherapy unit, tables that describe the output of the unit over the range of field' sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, G37 v ~
l
. ShtCA 3%=r /-Drge. Alarce /M7 '
sec. O 62 the measured timer accuracy for a typical treatment time, the calculated "on-off" error, the estimated accuracy ofeach distance measuring or localization device, and the signature of the teletherapy physicist.
see 649G rd Periame sont ch.ch A licensee authorized to use teletherapy Whits for medical use shall perform output spot checks on a.
each teletherapy unit at intervals not to exceed 1 month.
b.
To satisfy the requirement offr69a-0.'62a, spot checks shall include determination of:
i.
Timer constancy and timer linearity over the range of use; ii.
"On-off" error; iii.
The coincidence of the radiation field and the field indicated by the light beam localizing device; iv.
The accuracy of all dis:ance measuring and localization devices used for medical use; The output for 1 typicM set of operating conditions; and v.
vi.
The difference between the measurement made in 0.5%...G326.v. and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last j
full calibration corrected mathematically for physical decay).
i A licensee shall use the dosimetry system described in frf9G)s to make the spot check required c.
in 0.2.1.G.62b.v; d.
A lic~ensee shall perform spot checks required by 6-59s-G.'62a in accordance with procedures j
established by the teletherapy physicist. The teletherapy physicist does not need to actually perform the output spot-check measurements.
A licensee shall have the teletherapy physicist review the results of each output spot check within e.
15 days. The teletherapy physicist shall promptly notify the licensee in writing of the results of each output spot check. The licensee shall keep a copy of each written notification for 2 years.
i f.
A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility at intervals not to exceed I month.
g.
To satisfy the requirement of 6-59f-G32f., safety spot checks shall assure proper operation of:
l i.
Electrical interlocks at each teletherapy room entrance; l
l ii.
Electrical or mechanical stops installed for the purpose oflimiting use of the primary beam of radiation restriction of source housing angulation or elevation, carriage or stand travel, and operation of the beam "on-off' mechanism; i
G38
}
I Sec. G.62 - 0.6)
)
SSRCR &'olumel.Drajk March 1997 iii.
Beam condition indicator lights on the teletherapy unit, on the control console, and in the i
- facihty, iv.
Viewing systems; I
Treatment room doors from inside and outside the treatment room; and I
v.
vi.
Electrically assisted treatment room doors with the teletherapy unit eisctrical power j-turned "off."
. h.
A licensee shall lock the control console in the "off'. position if any door interlock malfunctions.
I No licensee shall use the unit until the interlock' system is repaired unless specifically authorized g
. by the Agency.
i.
A licensee shall promptly repair any system identified in G.Z, G.62g, that is not operating t
properly. The teletherapy unit shall not be used until all repairs are completed.
L j.
A licensee shall maintain a record of each spot check required by &59a-G.62a' and f. for 3 years.
The record shall include the' date of the spot check, the manufacturer's name, model number, and i
serial number for both the teletherapy unit, and source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, the timer i
constancy and linearity, the calculated "on-off' error, a d-termination of the coincidence of the i
radiation field and the field indicated by the light beam localizing device, the timer constancy and linearity for a typical treatment time, the calculated "on-off' error, th6 estimated accuracy cf each distance measuring or localization device, the difference between the anticipated output ard the -
i measured output, notations indicating the operability of each entrance door electrical interlock, j
l each electrical or mechanical stop, each beam condition indicator light, the viewing system and doors, and the signature of the individual who performed the periodic spot check.
j See -640G.63 Radiation Survevs for Teletherany Facilitigt Before medical use, after each installation of a teletherapy source, and after making any change a.
- for which an amendment is required by &5+G.54, the licensee shall perform radiation surveys with an operable radiation measurement survey instrument calibrated in accordance with
&t9G.21 to verify that:
. i.
The maximum and average radiation levels at 1 meter from the teletherapy source with the source in the "off' position and the collimators set for a normal treatment field do not exceed 100 microsieverts (10 mrems) per hour and 20 microsieverts (2 mrems) per hour, respectively; and ii.
With the teletherapy source iMhe "on" position with the largest clinically available treatment field and with a scattering phantom in the primary beam of radiation, that:
G39
-l
..~
~. -. -.
,,4 l
5 35RCR l*cirme! Draft, March 1997 Sec.0.62
.i (1)
Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Part D of these regulations;.and
.(2)'
Radiation levels in unrestricted areas do not exceed the limits specified in Part D of these regulations.
i b.
If the results of the surveys required in EiH56rG3M indicate any radiation levels in excess of the respective limit specified in that paragraph, the licensee shall lock the control in the "off" position and not use the unit:
' i.
Except as may be necessary to repair, replace, or test the teletherapy unit, the teletherapy
, unit shielding, or the treatment room shielding; or j '
ii.
Until the licensee has received a specific exemption from the Agency.
A licensee shall maintain a record of the radiation measurements made following installation of a c.
source for the duration of the license. The record shall include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the l
teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate i
measured around the teletherapy source while in the "off" position and the average of all measurements, a plan of the areas surrounding the treatment room that were surveyed, the t
measured dose rate at several points in each area expressed in microsieverts (mrems) per hour, the calculated maximum level of radiation over a period of I week for each restricted and unrestricted area, and the signature of the Radiation Safety Officer.
j See GeG 64 - Safet,y Spot Chech for Telethernov Facilitien_
i j
- ~ a.
A licensee shall promptly check all systems listed in 649 -G32s for proper function after each -
3 installation of a teletherapy source and after making any change for which an amendment is j'
required by 6++G.54.
b.
If the results of the safety spot checks required in 64trGi6d indicate the malfunction of any system specified in EH9G.62, the licensee shall lock the control console in the "off" position and l
not use the unit except as may be necessary to repair, replace, or check the malfunctioning i
j' system.
A licensee shall maintain a record of the safety spot checks following installation of a source for 3 c.
i' years. The record shall include notations indicating the operability of each entrance door interlock, each electrical or mechanical stop, each beam condition indicator light, the viewing system, doors, and the signature of the Radiation Safety Officer.
See G4!!!G 65 - Modification of Teletherany Unit or Room Before Beginning a Treatment Program If
- the survey required by 6-60G.63 indicates that an individual in an unrestricted area may be exposed to les els of radiation greater than those permitted by Part D of these regulations, before beginning the treatment program the licensee shall:
G40 l
..__4____
.Sec. G 63 G 64
.SSRCR Volume 1 Draft. March 1997
. Either equip the unit with stops or add additional radiation shielding to ensure compliance with a.
Pan D of these regulations; b.
.brform the survey required by 640GM3 again; and l.
- include in the repon required by 649G.6(the results of the initial survey, a description of the
~.c
_ modification made to comply wi h 64trG.65a.', and the results of the second survey; or t
d.
. Request and receive a license amendment under Pa n D of these regulations that authorizes radiation levels in unrestricted areas greater than th $se permitted by Part D of these regulations.
G 643G'55 - Renom of Talaskeny Sur= CF=En Tente and i'==m...==
Alicensee shall ihrnish a copy of the records required in 02,0.0;,023.63iG.64/G,.65 and the output from the teletherapy source expressed as grays (rads) per hour at 1 meter from the source as determined during the full calibration required in Erf6G:61 to the Agency within 30 days following completion of the action that initiated the record requirement.
{
i Sec 644G 67 - Five-Year Inenection A licensee shall have each teletherapy unit fully inspected and serviced during teletherapy source a.
i replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechamsm.
l
(
b.
This inspection and servicing shall only be performed by persons specNically licensed to do so by
- the Agency, an Agreement State, or the Nuclear Regulatory Commission.
A licensee shall maintain a record of the inspection and servicing for the duration of the license.
i c.
The record shall contain the inspector's name, the inspector's license number, the date of inspection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list'of components replaced, and the signature of the inspector.
Specific Requirements for Training See ' G45668 p =diation Enfety Oscer. Except as provided in fr46GL69, an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in 64G.9 shall:
o a.
- Be cenified by the:
I i.
American Board of Health Physics in Comprehensive Health Physics; or ii.
American Board of Radiology in R.J;vlv ;. 7.y;,.., Tl,s..ym.c Rod;vlvg;c.; P,g.w, l
er Med;c.; Lc, i ?l.y;u; or L
G41
_____.7 MCR %l Dnt.Mm* tw see.o.s3.o.s, iii.
American Board of Nuclear Medicine; or iv.
American Board of Science in Nuclear Medicine; or Board ofPharmaceutical Specialties in Nuclear Pharmacy e 1,;..
, or v.
vi.
American Board of Medical Physic. ;o ?
r--;=.. O. ~l
, 7:.,,;..; or vii.
Royal College of Physicians and Surgeons of Canada in Nuclear Medicine; or viii.
American Osteopathic Board ofRadiology; or ix.
American Osteopathic Board of Nuclear Medicine; or -
b.
Have had 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training covering:
i.
Radiation physics and instrumentation; ii.
Radiation protection; iii.
Mathematics pertaining to the use and measurement of radioactivity;
)
l -
iv.
Radiation biology; L
l v.
Radiopharmaceutical chemistry; and L
i Have had 1 year of full-time experience in radiation s' afety at a medical institution under i
vs.
l the supervision of the individual identified as the Radiation Safety Officer on an Agency,
. Agreement State, Licensing State, or the Nuclear Regulatory Commission license that authorizes the medical use of radioactive material; or Be an authorized user for those radioactive material uses that come within the Radiation Safety
]
c.
Officer's responsibilities.
i l
Sec 646G39 - Training for Exnerienced Rndistian Safetv O'Meer An individualidentified as a Radiation Safety Officer on an Agency, Agreement State, Licensing State, or Nuclear Regulatory Commission license on [ insert effective date of rule] who oversees only the use of radioactive material for which the licensee was authorized on that date need not comply with the training requirements of EHMG.68.:
see G44G 70 - Training for Uptifra Dilutinn or Ercretion Studia= Except as provided in &WG.8' 0 j
.nd 0.70, the licensee shall require the authorized user of a radiopharmaceutical listed in EHHG.34 to be
^
a physician who:
e s
a.-
Is certified in:
i G42
.. ~. _.
=.
L :..
- i Sec. G.GT
- G.68 l
SSRCR l'ohame1-Dreh March 1997
~ i.
Nuclear medicine by the American Board ofNuclear Medicine; or ii.
Diagnostic radiology by the American Bosrd ofRadiology; or L
iii.
Diagnostic radiology or radiology by the American Osteopathic Board ofRadiology; or
)
i iv.
Nuclear medicine by the American Osteopathic Board ofNuclear Medicine; or Nuclear medicine by the Royal College of Physicians and Surgeons ofCanada; or v.
b.
Has completed 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> ofinstruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, and 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> ofsupervised clinical experience.
i.
To satisfy the basic instruction requirement, 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom and laboratory instruction shallinclude:
(1)
Radiation physics and instrumentation; (2)
Radiation protection; (3)_
Mathematics pertaining to the use and measurement of radioactivity; (4)
Radiation biology; and (5)
Radiopharmaceutical chemistry.
- ii.
To satisfy the requirement for 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of supervised clinical experience, training must be j
under the supervision of an authorized user at a medical institution and shall include:
1 (1)
Examining patients br lisman reist'ch."subjests and reviewing their case histories j
to determine their suitability for radionuclide diagnosis, limitations, or i
contraindications; i
(2)
Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;.
l (3)
Administering dosages to patients 6Fhuiiiii'riIsIciidhEbj5fs and using syringe radiation shields; t
l (4)
Collaborating with the authorized user in the interpretation ofradionuclide test l
results; and t
(5)
Patient or b0rrianfedarcisubjst followup; or
~
i Has successfully completed a six-month trammg program m nuclear medicine as part of a training c.
program that has*been approved by the Accreditation Council for Graduate Medical Education l.
G43
~
1:
L,.-
e.
35NCR l'ohener!-Drap. March IH7 sec.O.ss.o.10 and that included cle x,cm and laboratory training, work experience, and supervised clinical experience in all the topics identi6ed in 6496G.706.
i see senGM. Training for f===ing and Loentivatian Studia=
Except as provided in 0.7'G.'86er t
frf6, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent i
specified in 6-39G.36 to be a physician who:
a.
Is certified in:
i.
. Nuclear medicine by the American Board of Nuclear Medicine; or j
ii.
Diagnostic radiology by the American Board of Radiology; or l
iii.
Diagnostic raaiutogy or radiology by the American Osteopathic Board of Radiology; or iv.
Nuclear medicine by the American Osteopathic Board of Nuclear Medicine; or.
Nuclear medicine by the Royal College ofPhysicians and Surgeons of Canada; or v.
b.
Has completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> ofinstruction in basic radionuclide handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, and 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical experience.
i.
To satisfy the basic instmetion requirement, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training shallinclude:
q (1)
Radiation physics and instrumentation; 1
(2)
Radiation protection; (3)
Mathematics pertaining to the use and measurement.of radioactivity; (4)
Radiopharmaceutical chemistry; and (5)
Radiation biology.
ii.
' To satisfy the requirement for 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
(1)
Ordering, receiving, and unpacking radioactive materials safely and performing the
' related radiation surveys; (2)
Calibrating dose calibrators and diagnostic instruments and performing checks for
_ proper operation of survey meter:;;
(3)
Calculating and safely preparing patient 67Eman reseaIcGubject dosages; i
G44
.-._ ___ _ -_ -. _ _._ _..__..- _ _. ~
.f.
s*
i
'Sec.G.10=0.11-1 SsRCR LWume!-Drgh March 1997
\\
(4)
Using administrative controls to prevent the misadministration ofradioactive material; 1
I (5)
Using emergency procedures to contain spilled radioactive nuterial safely and -
l usmg proper decontamination procedures; and i-(6)
Eluting technetium-99m from generator systems, assaying and testing the eluate i
for molybdenum-99 and alumina contamination, and processing the eluate with
. reagent kits to prepare technetium-99m labeled radiopharmaceuticals.-
u l
iii.
To satisfy the requirement for 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical experience, training shall under the supervision of an authorized user at a medical institution and shall include-L (1)
Examining patients MEddis*EsasrebMjkii and reviewing their case historie' s to determine their suitability for radionuclide diagnosis, limitations, or
[
contrair,dications; j
L
)
(2)
Selecting the suitable radiopharmaceuticals and calculating and measuring the 1
dosages;-
j t
(3)
Administering dosages to patients Br hwhairesearch subjects and using syringe radiation shields; (4)
Collaborating with the authorized user in the interpretation of radionuclide test -
L results; and i
1 (5)
Patient or human risearch ' subject followup; or Has successfully completed a six-month training program in nuclear medicine as pan of a training c.:
program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in fr69bG.71b.
t i
See Fr69G 72 - Trainino for Theraneutic Une ofRamonharmwantic=1= Except as provided in 645G.80, the licensee shall require the authorized user of a radiopharmaceutical listed in ErS9G A0 for therapy to be a physi:ian who:
' s.
Is certified in:
i 1
i.
Nuclear medicine by the American Board ofNuclear Medicine; or ii.
Radiation oncology, therapeutic radiology, or radiology by the American Board of j
Radiology; or iii.
Nuclear medicine or radiation oncology by the American Osteopathic Board of Radiology i
after 1984; or L
I G45
- s 7
b SSRCR IMume! Drd.Mank I997 Sec. G.71 iv.
- Nuclear medicine by the R'oyal College of Physicians and Surgeons of Canada; or m
b.
Has completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> ofinstruction in basic radionuclide handling techniques applicable to use of therapeutic radiopharmaceuticals, and has had supervised clinical experience.
i.
To satisfy the requirement for instsuction, 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training shallinclude:
i (1)
Radiation physics and instrumentation; (2)
Radiation protection;
.(3)
Mathematics pennining to the use and measurement ofradioactivity; and (4)
Radiation biology; i
l ii.
To satisfy the requirement for supervised clinical experience, training shall be under the L
supervision of an authorized user at a medical institution and shall include:
l (1)
Use ofiodine-131 for diagnosis of thyroid function and the treatment of l
hypenhyroidism or cardiac dysfunction in ten individuals; j
(2)
Use of soluble phosphorus-32 for the treatment of ascites, polycythemia vera..
l leukemia, or bone metartases in three individuals; e
1
-(3)
Use ofiodine-131 for treatment of thyroid caremoma m three individuals (4)'
Use of colloidal chromic phosphorus-32 or of colloidal gold-198 for intracavitary treatment of malignant effusions in three individuals; and
-i L
(5)
Use of strontium-89 as strontium chloride for the treatment ofpain associated with bone metastases in three individuals.
i Sec fr40G 73 - Trainino for Thernamiitic Use of Brachytheranv Sourca. Except as provided in fr45G.80, the licensee shall require the authorized user using a brachytherapy source specified in fr43G.M for therapy to be a physician who:
a.
Is certified in:
\\
i.
Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or 1
ii.'
Radiation oncology by the American Osteopathic Board of Radiology; or iii.
Radiology, with a specialization in radiotherapy, as a British " Fellow of the Faculty of j
l Radiology" or " Fellow of the Royal College of Radiology"; or
~
i, -
s G46 l
~
Sec. G.71 G.72 i
SSRCR Volume 1 Draft. March 1997 iv.
Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or b.
Is in the active practice of therapeutic radiology, has completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> ofinstmetion in basic radionuclide handling techniques applicable to the therapeutic use of brachytherapy sources and
- 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience and a minimum of three years of supervised clinical experience.
i.
To satisfy the requirement for instruction, 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training shallinclude:
l (1)
Radiation physics and instrumentation; l
-(2)
Radiation protectior.:
(3)
Mathematics pertaining to the use and measurement of radioactivity; and
- (4)
Radiation biology.
l ii.
To satisfy the requirement for 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, training shall be under the supervision of an authorized user at a medical institution and shall include:
(1)
Ordering, receiving, and unpacking radioactive materials safely and performing the rdated radiation surveys; i
(2)
Checking survey meters for proper operation;
\\
(3)
Preparing, implanting, and removing sealed sources; (4)
Using administrative controls to prevent the misadministration ofradioactive material; and (5)
Using emergency procedures to control radioactive material.
iii.
To satisfy the requirement for a period of supervised clinical experience, training shall include one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or 1
i the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision l
of an authorized user at a medical institution. The supervised clinical experience shall include:
(1)
Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications; 4
(2)
Selecting the proper brachytherapy sources, dose, and method of administration; t
(3)
Calculating the dose, and G47 l
m.
__.__.__.__..__._,_.m
}
.SSROt l'olnwI-Drg/t. March 1997 -
Sec. G.72 0.73 (4)
Post-administrationi followup and review of case histories in collaboration with the l
authorized user.
o i
' E.e G+4dN - Training for Onhthm1mic Une of Strontium-90 Except as provided in 645G 86 the licensee shall require the authorized user using only strontium-90 for ophthalmic radiotherapy to be!
L physician who:
I L
a.
Is certified in radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or b.
Is in the active practice of therapeutic radiology or ophthalmology, and has completed 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of instruction in basic radionuclide handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy i.
To satisfy the requirement for instruction, the classroom and laboratory training shall include:
(1)
Radiation physics and instrumentation; 1
1 l
(2)
Radiation protection; (3)
Mathematics per:aining to the use and measurement of radioactivity; and l
(4)
Radiation biology.
ii.
To satisfy the requirement for a period of supervised clinical training in ophthalmic radiotherapy, training shall be under the supervision of an authorized user at a medical institution and shall include the use of strontium-90 for the ophthalmic treatment of 5 l
individuals that includes:
(1)
- Examination of each individual to be treated; (2)
Calcula: ion of the dose to be administered; l
(3)
Administration of the dose; and t
(4)
Followup and review of each individual's case history.
l See G4tG!75 - Training for l'se of Samlad Sources for Dr gnnai. Except as provided in 645G;50, the licensee shall require the authorized user using a sealed source in a device specified in GMG.44 to be a physician, dentist, or podiatrist who:
l l
a.
Is certified in:
i i.
Radiology, diagnostic radiology JJ,ysd.;
...ymmm. ;n 1
..J;viv,y, therapeutic radiology, or radiation oncology by the American Board of Radiology; or i
G48
.,e*'
1 Sec.0.13*G.14 SSRCR Volume 1 Drqft. March 1997 1
ii.
Nuclear medicine by the Ainerican Board of Nuclear Medicine; or iii..
Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or iv.
Nuclear medicine by the Royal College ofPhysicians and Surgeons of Canada; or b.
Has completed 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory instruction in basic radionuclide handling i
techniques specifically applicable to the use of the device.
i.
To satisfy the requirement for instruction, the training shall include:
(1)
Radiation physics, mathematics pennining to the use and measurement of radioactivity, and instrumentation; (2)
Radiation biology; and (3)
Radiation protection and training in the use of the device for the purposes
. authorized by the license.
See G49G 76. Trainina for Teletherapv. Except as provided in 695680, the licensee shall require the authorized user of a sealed source speci5ed in fr490.52 in a teletherapy unit to be a physician who:
a.
. Is certified in:
i.
Radiology, therapeutic radiology, or radiation or.co!cgy by the American Board of Radiology; or ii.
Radiation oncology by the American Osteopathic Board ofRadiology; or iii.
Radiology, with specialization in radiotherapy, as a British " Fellow of the Faculty of i
Radiology" or " Fellow of the Royal College of Radiology"; or iv.
Therapeutic radiology by the Canadian Royal Co!!ege ofPhysicians and Surgeons; or l
b.
Is in 'the active practice of therapeutic radiology, and has completed 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> ofinstmetion in basic radionuclide techniques applicable to the use of a sealed source in a teletherapy unit,500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, and a minimum of 3 years of supervised clinical experience.
l i.
To satisfy the requirement for instruction, the classroom and laboratory training shall include:
(1)
Radiation physics and instmmentation; i
(2)
Radiation protection; (3)
Mathematics pennining to the use and measurement of radioactivity; and i
i G49 l
1
-.. _ - ~. ~.. - -. - _ _ _ - _ -.
l
?
JERCR Mmne!.Denft. Mach 1997
'i see. o.74. o.ys (4)
Radiation biology.
ii.
To satisfy the requirement for 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience, training shall be under the supervision of an authorized user at an institution and shall include:
(1)
Review of the full calibration measurements and periodic spot check;;
l l
(2)
Preparing treatment plans and calculating treatment times; (3)
Using administrative controls to prevent misadministrations; i
(4)
Implementing emergency procedures to be followed in the event of the abnormal -
operation of a teletherapy unit or console; and
-(5)
Checking and using survey meters.
iii.
To satisfy the requirement for a period of supervised clinical experience, training shall include 1 year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the l
Committee on Postdoctoral Training of the American Osteopathic Association and an l
additional 2 years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution. The supervised clinical experience shall l
include:
-(1)
Examining individuals and reviewing their case histories to determine their suitability for teletherapy treatment, and any limitations or contraindications; (2)
. Selecting the proper dose and how it i: to be administered; (3)
Calculating the teletherapy doses and collaborating with the authorized user in the -
review of patients' M humanf5ssiltJUlijes' progress and consideration of the need to modify originally prescribed doses as warranted by patients' 5f humaii reseash subjects! reaction to radiation; and (4)
Post-administration followup and review ofcase histories.
Ecc 6-94G 77. Trainino for Telethermey Phvmiciet The licensee shall require the teletherapy physicist to:
Be certified by the American Board of Radiology in:
a.
i.
Therapeutic radiological physics; i
ii.
Roentgen-ray and gamma-ray physics; 3
l iii.
X-ray and radium physics; or G50
.. -.. - - ~.
- ~.. -.
]
j l
S** G.TG i
SSRCR Volume 1 Draft. March 1997 iv.
Radiological physics; or b.
Be certified by the American Board ofMedical Physics in radiation oncology physics; or Hold a master's or doctor's degree fr_m..__dited. du_ ate.. program in physics, biophys c.
~,
.., ~, _.
o an accre gra l.
radiological physics, or health physics,[orhEM] and have completed 1 year of full time l
training in therapeutic radiological physics and also 1 year of full time work experience under i
supervision of a teletherapy physicist at a medical institution. To meet this requireme individual shall have performed the tasks listed in Ol;, 0.5:;, 0.3,..J 0.G G,2(G.6t,G.62 iind O.'63"under the supervision of a teletherapy physicist during the year of work ex l
nG;rgWe q"pgggggwpgr22ESTh'liUI5iisIeE'iiiallhiiil5iitliId'50ididriiled e
adclear phsfrmacistMlpharmacid.who; amjHas current b,oard c,e. ification as a nue'n.,. n,.. lear pharmaci.s4....,;. die. Board..k, Ph
....-mr u~~
.. p.mnm,
..v e
..n.
,w v.m v...
ah rt l
m,.i.ih or' a
l i
i b*.... w..
i l
8j..e9 dix' 4...%.A%, ha,A. i %s complesg.ed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> inla s#.
... YI
.is.
A e.,4,y s-2.*4,.
.s
.%...NA..,,..
..4
.,... A.g.g 9
l pr,... A.s, v' a 44.*,ogram consisting of)oth:
tructured ' ducationa,c
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p f.iii.. TV@obiaMMttAIMirtificationi'siddd ti/iprecept6I6t6ridd #Eiclear phardsicist2that the above training hiui bien satisfactorily completsd and that the*mdividual has achieved a level of coinpesency sufficientisMp-adently 6perate"a nucles(pharmacy, T
EM"G' 797 sinintfdEF7nWR NLtA"J PhEEUTX"@May a%1y'fdfin5d isidiredeke~a T
l license amendmentidentifying' ~any experienced, nuclear pharmacist aan;autho/u i nGclearpharmacist before it allows 'this' individual to wbrk"as an authorized nuclear pharmacist?A phadnacistMo hsis
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completed a st'ructufed erbr=*ianal program as specified in G.73b.i;.before [ insert effective dadsfNie],
1 and who'is Working inV6clesir pharmacy wo61d qualify.as an sipsriEced Mcleir' pharmacist.iXs i
experienced n'uclear' pharmacist'need n6t' comply;with the requi.
ds on precepior' statement;(G.78ti.ii) andiecentness of trQ.lug (G,8.1) to qualify as.an authorized. nuclear lphannacist.
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See G-MG 80 - Trainino for Exnerienced Authorized Users Practitioners of the healing arts identified j
j as authorized users for the human use of radioactive material on an Agency [, the Nuclear Regulatory Commission or Agreement State or Licensing State] license on (insert effective date of rule] who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of fr66G.68 through 6-MG.81.
l Sec. fr96G.81 - Physician Traimng m a Three-Month Program. A physician who, before July 1,1984, j
began a three-month nuclear medicine training program approved by the Accreditation Council for Graduate Medical Education and has successfully completed the program, is exempted from the requirements of 6-69G.70 or 648G.71.
Sec Cr-MG 82 - Recentness ofTraininn The training and experience specified in 6-65G.68 through 6-94G,77 shall have been obtained within the 57 years preceding the date of application or the individual shall have had continuing applicable experience since the required training and experience was completed.
j G52 l
i
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l Rationale to DRAFT Part G - March 1997 1997 Rationale for Revisions i
Part G Use of Radionuclides in the Healing Arts Introduction Significant changes have resulted from 1) NRC's radiopharmacy rule; 2) changes in patient release j
criteda; and 3) a revision of the quality management rule by the committee. The current Part G suggested modified langu;ge for the " quality management program" based on the committee's j
judgement that NRC's requirement was overly prescriptive.
l The committee believes that the NRC radiopharmacy regulations should be incorporated in Part G because of their connection to nuclear medicine. Therefore, new defmitions and sections have been.
added to inchtde Radiopharmacy into Pan G.
r j
Patient rclease rules have been changed to more closely follow the exposure limit criteria specified F
in Part D.
l In this revifa to Pan G, the focus has been on providing model regulations which can be adopted l
- by individu,J states without concem that Division 1 and Division 2 matters of compatibility will be l
raised following adoption. Therefore, the NRC language was included in its entirety, however, sections tir.t the committee deemed to be too prescriptive and which do not appear to be based on health and safety criteria, are placed in brackets. These bracketed sections mug be adopted by any j
state which wants to assure compatability with the NRC.
The addition of tmns appropriate for human research as established in the Purpose and Scope section were inserted as needed in the entire document without further reference.
l With the addition of n:w sections, all sections from G.3 and above have been renumbered. Cross references intemally have been updated. Minor editing was also performed without further reference below.
I Snecific Provisions -
i 91 Pumose and Scope. Terms approp6te for human research use by the licensee are added.
l i
G.2 Definitions. "AuthorQed nuclear pharmacist" and " visiting authorized nuclear pharmacia" were j
added. Because "r comble event"is only used in a bracketed area of this revision, its definition is also bracketed. TAuefinition must be included fer comentability ourposes if the bracketed nortion i
of the OM rule is adoote ! by a state. The defindtion of" medical use"is revised to be compatible with the NRC definition. his is done to include medical research on human subjects by authorized l
_ ~. _
i Ranonale to DRAFT Part G - March 1997 users.
G.3 Pmvision for R escarch Involvine Human Sabiects. This section is added (as the NRC has a it) to include medical research subject limitations to the rules.
G.4 FDA. Other Federal. and State Reaul-e.- x. As the NRC has done, this non exclusion statement is added to assure that all applicable rules are followed by the licensee.
G.5 License Recuired. A supervision statemect is added to this section. This and all sca-ding sections have been renumbered relative to the previo9s edition.
G.6 License Amendments. Addition of visiting authorized nuclear pharmacist to b.
G.8 ALARA Pronram Addition of authorized nuclear pharmacist to b.ii.
t G.10 Radiation Safety Committee. Addition of authorized nuclear pharmacist to b.ii.
G.12 Suoervision. Addition ofnuclear phannacist supervision statement as b., and a more general statement of the responsibility of the authorized users for individuals under their supervision.
G.13 Visitine Authorized User. The regulation now allows individuals listed on broad scope licensee's permits to act as visiting authorized users.
G.14 Visitine Authorized Nuclear Pharmacist. A new section to allow nuclear pharmacists to act as visiting authorized nuclear pharmacists with the same requirements as visiting authorized users.
G.16 Oualitu,Mananement Prorram. This section is changed to show the committee's belief that there should be a written QMP but the prescriptive elements should be left to the judgement of the individual state. Since the QM rule is a matter of compatibility, any additional worchng required for compatability is provided in the bracketed text. Any state wMine to assure camnatibility with the NRC must incomorate the bracketed text. Additional bracketed text is added which reflects the NRC's approved wording regarding submission of the written QMP to the Agency. This wording i
is taken from the All Agreement States Letter SP-95-184. These sections,if adopted, allow more flexibilityin submbsion requirements for the written QMP than the original QM rule. However, the committee believes that the QM rule is overly prescriptive, and the committee takes note that the i
NRC's implementstion of that rule relative to Agreement States has been deferred. The NRC staff is reviewing their findings on the rate ofmisadministrations since implementation of this rule. These findings may call to question the effectiveness of this rule.
The focus is on assuring that radiation is administered as intended by the authorized user through policies and procedures for preparmg wrinen directives, verifying patient identity, updating i
clinical procedures, validating treatment plans, identifying and evaluating deviations, and conducting an annual evaluation., The licensee is allowed (by NRC and therefore by this section of Part G as
~
l Rationale to DRAFT Part G - Manh 1997 1
well) to modify its quality management program without prior approval of the Agency.
The NRC requires the licensee to submit a copy of the licensee's quality management program to NRC along with a certification that the program has been implemented. The committee believes this could impose a significant resource burden on the states, especially where Agency required submittals must be reviewed within a time frame fixed by internal procedure or state law.
The resulting peak workload could cause the Agency to forego other licensing actions and/or licensee i
inspections to the overall detnment ofpublic health and safety and the effectiveness of the radiation control program.
G.20 Possession. Use. Calibration. and Check of Dose Calibrators. Section b.iii. has been modified to require the linearity to be performed over the range of use, rather than specifying a 10 or 30 uCi l
minimum. An optional, bracketed statement requires the dose calibrator to be posted with the range over which the unit's linearity was approved. The mathematical corrections required in section c.
i are now required only for dosages which exceed 30 uCi instead of the previous 10 uCi. The committee sees no reason to require a linearity to be performed in an activity range that is not used.
Very few doses are given which fall below 100 uCi, and most dose calibrators lose continuity at activities nearing 10 uCi. In addition, the effects of such low doses are negligible.
]
2 G.22 Assay of Radionharmaceutical Dosanes. The section has been revised to require assaying of j
dosages containing activities greater than 30 uCi instead of the current 10 uCi minimum. See l
rationale for G.20 above.
4 G.30 Release ofIndividuals Containing Radiocharmaceuticals or Imolants. We have incorporated i
the NRC's new patient release criteria, but have gone farther in that we have included individuals i
j with temporary implants. This section now also incorporates both sealed source and unsealed i
sources of radioactive materials, and therefore replaces the old sections G.39a.vii., G.39b.and G.45a.v. which have been deleted. States are reminded that additional documentation must be performed and kept by the licensee which shows the basis for releasing an individual.
G.34 Use of Radiooharmaceuticals for Uotake. Dilution. or Excretion Studies. This section has been modified to approve any radioactive material prepared for medical use by a licensed manufacturer or preparer or which has been prepared by an authorized nuclear pharmacist, an authorized user or an individual under their supervision. This reflects the same changes made by the NRC. This gives the licensed user more latitude and encroaches less on both the practice of medicine and pharmacy.
It also allows the use of new, approved products (such as radiobiological imaging agents) without the need for a license amendment.
G.36 Use of Radiopharmaceuticals. Generators. and Reanent Kits for Imaring and Localization Studies. Same as G. 34 above.
G.37 Radionuclide Contaminants. The SI unit conversions are corrected.
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9
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l j
Rationale to DRAFT Part G - March 1997 l
l i
G.40 Use ofRadionhannaceutients for Thernov. Same as G. 34 above.
G.42 Safety Precautions, Sections a. vii. and B. have been deleted and are now covered under the rivised 0.30.
i I
G.48 Safety Pientions. Section a. v. is deleted because it is now covered under the revised G.30.
l G.50 Release of Patients or Human Racamh Subiects After Removal of Tmr-:.r.sv imalants.
l.
Because a number of current temporary implant pmcedures are performed as outpatient procedures 4
(Ex.1-125 eye plaques), the wordmg in a., which requires that the patient not be released from confinement until after all implants are removed, has been deleted. G.30 now includes umyer ry implant patient release criteria, and G.50 now deals with the procedures to be followed after removal i
of these temporary implants.
4 G.68 Radiation Safety Officer. Deleted the specialty certifications from the American Board of
[
Radiology and the American Board of Medical Physics. This reflects the changes made by the NRC and also that the specialty in radiation oncology physics is not offered any more by the American Board of Health Physics. The committee believes that certification by either of these Boards is adequate.
G.75 Training for Use of Scaled Sources for Diarnosis. Delete the special competence in nuclear radiology requirement for certification by the American Board of Radiology in radiology as has been done by the NRC.
G.77 Training for a Telethersov Physicist. Add the requirement that the master's or doctor's degree be obtained from an accredited graduate program, and include 'or the equivalent' of the listed degrees. The committee believes that only accredited programs can assure competence in the individuals training. Also, the name of the degree specialty is not as important as the curricula contents.
G.78 Training for an Authorized Nuclear Pharmacist. The minimum training requirements are adopted from Appendix A of the NRC's " Guide for the Preparation of Applications for Nuclear
' Pharmacy Licenses".
G.79 Training for Exoerienced Nuclear Pharmacist. This section is added and is similar to the requirements for training for experienced authorized users in G.80.
G. 82 Recentness of Training. Specified training and experience must now have been obtained within the last 7 years rather than the last 5 years. This change corresponds to 635.972 in Part 35.
- - -... - - -.. ~ _ _.
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i Rationale to DRAFT Part G - March 1997 s
s SSRCR Part G i
l Matters for Future Consideration Broad technicalissues i
1.
Whether veterinarians should be regulated as pan of the medical community under Part G (or is use. of radionuclides in the healing arts only for direct application of radiation to.
humans).
I j
2.
Whether site specific immunotherapy (monoclonal antibodies) requires special regulations added to Part G.
4 3.
. Whether High Dose Rate Afterloaders require special regulations added to Part G.
This is included in the committee 's recommendations to the NRC.
i i
{
4.
Whether many of the current provisions of Part G are overly prescriptive, do not apply
{
uniformly to large and small licensees, and are better addressed in licensing guidance.
Some work done but more needed. This subject is also included in the comminee's recommendations to the NRC.
l 5.
How best to address pure beta-emitters and alpha emitters in incorporation of the " Patient Release Criteria".
6.
Whether medical licensee management should be given broader authority to approve authorized users and visiting authorized users as long as they meet the current training and experience requirements and whether the licens'ee needs to do more thanjust document the users credentials or report when an authorized user leaves the licensee.
This has now been donefor Broad Scope licensees and by allowing visiting authorized users.
However this doesn 't allow the licensee to automatically approve new. full time users. This
^
may not be appropriate at this time, because ofthe recommendations made by the committee to simphfy and relax the rules based on risk based health and safety concerns. After more experience is gained with the potentially new concept ofrelaxed control over diagnostic NM and importance ofthe authorized user to the success ofthe medicalprogram at afacility.
this subjectshould be revisited.
7.
Whether the physician user should be present dunng radiopharmaceutical therapy procedures
- since potential consequences to personnel, facilities, the patient, and the public could be severe.
No evidence ofproblems in this area have become evident at this point under the current regulations.
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i a
o-Rationale to DRAFT Part G - March 1997 1
}
8.
Whether the term " confinement for medical care" should be more specifically defined to mean an area under the direct control of the licensee and not the patient's home or a hotel t
room; and under what circumsfances may non-hospitalized patients receive radiopharmaceutical therapy.
New nicase criteria have taken care ofthis a miit will be dropped in thefinal draft.
t I
9.
Whether there is a need for a separate quality assurance section for therapy.
}.
If the recommendations to the NRC become reality, it is likely that a separate, or more i
comprehensive quality assuranceprogramfor therapy will be nquired.
e I
' 10.
Whether 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training is sufficient background for a Radiation Safety Officer and whether this training should be in a 4 yearsectedited college or university, i
i The accreditation requirement has been added. Other training requirements should be reviewed.
J lI.
- Whether training and experience requirements have been adequately addressed through the currently recognized certifying boards; whether additional boards should be recognized or, j '
in some cases, whether a currently approved board should be removed from'the approved list; and whether the training and experience requirements themselves need to be updated, including consideration ofrequirements for nuclear cardiology.
' Assignments have been made; Barbara Hamrick is to review training requirementsfor i
i authori:ed users. and Cathy Fontaine is to review training requirementsfor technologists.
i l
Soccific Technical Issues (These issues should be taken :p vith the NRC during the Part 35 rewrite.)
\\
j i
i 12.
Whether the definition for " brachytherapy" in G.2 should include reference to solid and I:
plated sources in addition to sealed sources being utilized to deliver a radiation dose i
1 13.
Whether the geometry test in G.20b.iv. is needed given the current state of dose calibrator
[
technology.
4 14.
Whether the calibration requirements in G.21 should be updated to address minimum i
E instrument requirements for area contamination surveys, probe efficiency, the emission energy spectrum of sources used for calibrations, and the use of electronic pulsers.
1 4
l 15.
Whether the maximum amount allowed under the general license in G.23a. should be increased to accommodate the larger sources used for SPECT floods.
The committee recommended that NRCgo to dose rate limitsfor any sealed source as i.s donefor GL 's.
16.
Whether there is justification to add I-125 seeds to the list of exemptions from the leak test requirement ir} G.24f.iv.
d
t
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j' Rationale to DRAFT Part G - March 1997 p
17.
Whether the removable contamination detection limits in G.29 are too restrictive.
j.
I 8.'
Whether the survey requirements in G.29 should be updated to address efficiency of portable survey instruments, and whether exemptions for areas where only radioactive materials with j
. extremely short half lives are used should be added.
19.
Whether the requirements for storage of voleiles and gases in G.32 should be updated to
)
l-address the use of storage containers and shielding eauivalent to the shippers' radiation shield i
' and container, and the storage of syringes, etc. prepared for patients but not yet adminia'ed.
i 20.
Whether the decay-in-storage requirement in G.33a.i. to hold radioactive material for a minunum of ten halflives is warranted when an appropriate survey meter cannot di*iaguish 4
any readings above background even before that time is reached.
l 21.
Whether radionuclide contaminant levels should be cited by reference to the United States Pharmacopeia rather than specified as they currently are in G.37.
22.
Whether the control of aerosols and gases as specified in G.38 employs overly conservative assumptions when applied to Xe-133 (i.e., assuming uniform distribution upon release in a room; not treating a Noble gas as an extemal source only, etc.).
23.
Whether a survey instrument is really needed for licensees using sealed sources for diagnosis (G.45).
24.
Whether the teletherapy room viewing system requirement in G.59 should require aural communication as well as visual observation.
25.
Whether the requirement for a calibrated dosimetry system in G.60 should be a performance standard so that groups other than NIST or AAPM can participate.
Editorialissues 26.
Whether clarification is needed for certain terms such as " compounding", " availability to communicate immediately", " treatment site" and " type of use" m
27.
Whether sections enforcing general considerations that apply equally as well to radiation machines or to a broader segment of radioactive materials users should be moved to Part A or Part D where they would be applicable to all radiation users. Examples of such sections include: G.6 License Amendments, G.7 Notification, G.8 ALARA "ivgi-m, G.9 RSO, G.10 RSC, G.11 Authority and Responsibilities, G.12 Supervision, G.19 Quality Control, G.21 Calibration and Check of Survey Instruments, most of G.24 Requirements for Possession of Scaled Sources (leak tests), G.29 Surveys for Contamination, and G.56 Doors, Interlocks, and Waming Systems. Only specific requirements conceming radionuclides in the healing
.4?*o*
4 i
l Rationale to DRAFT Part G - March 1997 e
arts would then temmin in Part G.
28.
Whether definitions applicable to more than one Part, such as " area of use", " management",
l-and " therapy physicist", should be moved to Part A.
l 29.
Whether redundant or repetitive sections, such as G.35, G.43, G.45, G.51 and G.57 which similarly address possession of survey instruments, and G.41, G.47 and G.55 ::onceming safety instruction, should be combined.
i 30.
Whether values repeated in different units of measure should have the same number of significant digits, e.g.15 mci and 550 MBq (rather than 555 MBq), and whether the metric coefficient that will give numbers larger than one should be used.
9
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TASK DESCRIPTION - SUGGESTED STATE REGULATIONS - PART G "USE OF
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RADIONUCLIDES IN THE HEALING ARTS" FOR REVIEW REQUESTING OFF. - SR-6 REQUESTER - D. WALTER /AL WITS -
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I
I MEMO To:
SR-6 Committee Members, Advisors and Federal Resource Persons David Walter, Chairman h From:
Subject:
First Draft of Revisions to Part G Date:
March 13,1997 Enclosed is the first draft of the Part G rules changes and the rationale for the changes. - Please review this draft and give me you comments no later than April 21 so I can have them for the CRCPD meeting in Tacoma.
. After review, I left the " Physician Training in a Three-Month Program"in the rules. Consider the following scenario: A physician who was approved under this provision to license a one physician, private practice nuclear medicine facility in Alabama, decides to move to your state and work in the nuclear medicine department of one of your licensees. Although he has been practicing nuclear medicine continuously, he no longer meets any training criteria in the revised rules. Therefore,-
without an exception to the rules, he is barred from practicing nuclear medicine in your state. This is the reason Ileft it in.
~ I also want to give you the latest info about the Part 35 working group. I was told late last week that the NRC requested only one Agreement State and one non-Agreement State representative to be on the work group. I was then told that I had been assigned to the work group. Yesterday, I was notified that the initial meeting of this work group starts Monday, March 17 and will go through the 21st. The non-Agreement State individual is Marcia Howard from Ohio. The Commission wants an outline of the new rulemaking by June 15,19971 We will be very busy!.
I will still try to keep each of you informed of what transpires at the meetings so you can give me comments.
Our. office is moving on or about April 1 to a new building. My new direct telephone line number will be (334) 206-5394 and my fax number will be (334)206-5387. Soon (in government terms) after moving I hope to get on the Internet and get an E-mail address. I will let you know when that happens. My mailing address will not change:
The Alabama Department of Public Health Division of Radiation Control P.O. Box 303017 Montgomery, AL 36130-3017 I look forward to receiving comments from all of you.
I:
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