ML20199E357
| ML20199E357 | |
| Person / Time | |
|---|---|
| Issue date: | 12/22/1997 |
| From: | Bolling L NRC |
| To: | Salomon S, Usilton B NRC |
| Shared Package | |
| ML20199E212 | List: |
| References | |
| NUDOCS 9802020140 | |
| Download: ML20199E357 (107) | |
Text
- _
l Frome ' Lloyd Bolling To SNS, BGU Date 12/22/97 11:10am
! subjects Task # 78321 Steves l I have completed my review of the fo'. lowing sections of the Utah regulations:
- 1. R313 32. Medical Use of Radioactive Material, and
- 2. R313 12.- General Provisions.
Both sections are compatible and I have only a few minor comments (typos) which are contained in the hardcopy provided to you earlier.
Brenda Please close-out my ticket on this task.
For your RATS:
The revisions to Utah's R313-32, Medical Uses of Radionuclides, implement the following NRC regulations -
- 1. Quality Management Program and Misadministrations. 56FR34104 Effective 1/27/92 (all parts)
- 2. Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for Medical Use- 59FR61767 Effective 1/1/95 (Part 30 Definitions &
Part 35)
- 3. Medical Administartion of Radiation and Radioactive Materials. 60FR48623 Effective 10/20/97 (Part 20 Definitions & Part 35)
- 4. Release of Patients Administered Radioactive Materials- 62FR4120 Effective {
S/29/97 (Part 20 Definitions & Part 35)
Please let me know if you have any questions.
Lloyd-
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O 1 R313. anvironmental Quality, Radiation control.
2 R313 13. General Provisions.
3 R313 13 1. Authority.
4 The rules set forth herein - are adopted pursuant to the provisions of 5 sections 19 3 104(3) and 19 3 104 (6) and 63-38 3.
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8 R313 13 3. Purpose and scope. d -(Atyg It is the purpose of these rules to state such requirements as shall be bj 9 applied in the use :sf radiation, radiation machines, and radioactive materials 10 to ensure the max uum protection of the public health and safety to all persons 11- at, or in the vicinity of, the place of use, storage, or disposal. These rules 12 are intended to be consistent with the proper use of radiation machines and 13 radioactive materials. Except as otherwise specifically provided, these rules 14 _ apply to all persons who receive, possess, use, transfer, own or acquire any :
15 sourcs of radiation, provided, however, that nothing in these rules shall apply 16 to any person to the extent such person is subject te regulation by the U.s.
17 Nuclear Regulatory Commission. See also R313 12-55, 18
. 19 R313 12 3. Definitions. 4 [ee [ he 4 -
[
20 As used in these rules, these terma shall have the definitions set forth 21 below. Additional definitions used only in a certain chapter will be found in 22 that chapter.
23 'A" means the maximum activity of special form radioactive material 24- permitted in a Type A package.[-]
25 _"A " means the maximum activity of radioactive material, other than special 3
26' form radioactive material, permitted in a Type A package. These values are 27 either listed in R313-19100, Table 4, or may be derived in accordance with the 28 procedures prescribed in R313-19-100 (19) .
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- Absorbed dose a means the energy imparted by ionizing radiation per unit 2 mass of irradiated material. The units of absorbed dose are the gray (Gy) and 3 the rad.
4 aAccelerator produced materia;* means a material made radioactive by a 5 particle accelerator.
6 'Act" means Utah Radiation Control Act, Title 19, Chapter 3.
7 ' Activity" means the rate of disintegration or transformation or decay of 8 radioactive material. The units of actis ny are the becquerel (Bq) and the curie 9 (C1).
10 "Adulta means an individual is or more years of age.
11 aAddress of use* means the building that is identified on the license and 12 where radioactive material may be received, used or stored.
13 " Agreement Statea means a state with which the United States Nuclear 14 Regulatory Commission has entered into an effective agreement under Section 274 15 b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689) .
16 " Airborne radioactive materiala means e radioactive material dispersed in 17 the air in the form of dusts, fumes, particulates, mists, vapors, or gases.
'18 ' Airborne radioactivity aren means a
a room, enclosure, or area in which 19 airborne radioactive material exista in concentrations:
20 (a) In excess of the derived air concentrations (DACs), specified in R313-21 15, or 22 (b) To such a degree that an individual present in the area without 23 . respiratory protective equipment could exceed, during the hours an individual is 34 present in a week, an intake of 0.6 percent of the annual limit on intake (ALI),
25 or 12 DAC hours. --
26-
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- As low as. reasonably achievable" (ALARAY means me, ng every reasonable 87 effort to naintain exposures to radiation as far below the dose limits as is 28 practical (r 2
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1 ( F=). evnoistent with the t >ose f or which the licensed or registered 3 activity is undertaken [t hohldj 3 (H ). taking into account the stai e of technology, the economics of V
4 improvements in relation to_rtate of taw 6MEtyp the ecenomico of 1merovemento f, in reintiet to benefits to the pul nealth and safety, and other societal and gg ,.
6 socioeconomic considerations [t) and[
NRC Comments on the Utah Administrative Code, Rules R31312, R313-14, and Required for Compatibility or Health and Safety State NRC Categorv Begulation Regulation Subiett and Commenti A R31312 3 10 CFR 20.1003 ALARA The definition omits the pH se, 'the economics of improver i relation to state of technology,' th . a present in the NRC regulation. Because this is a category A provision, the Utah definition should be esseatially Idontical to the NRC definition.
Consequently, to be conipatible, the phrase should be inserted into the Utah definition.
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tal a radioactive material, with the exception of special nuclear 27 material, yielded in or nade radioactive by exposure to the radiation incident 28 to the process of producing or utilizing special nuclear material; and 3
1 7- M ) in relation to utilization of nuclear energy and licensed or ~ '
8 registered sources of radiation in the public interest.
9 " Area of use a means a portion of an_ address of use that has been set aside 10 for the purpose of receiving, using, or storing radioactive material.
11
- Background radiation a means radiation from cosmic sources; naturally 12 occurring radioactive materials, including radon, except as a decay product of 13 source or special nuclear material, and including global fallout as it exists in 14 the environment from- the testing of nuclear explosive devices.
- Background 15 radiation a does not include sources of radiation f rom radioactive materials 16 regulated by the Department under the Radiation Control Act or Rules.
17 *Becquerela (Bq) means the SI unit of activity, one becquerel is equal to 18_ one disintegration or transformation per second.
19 asioassa) means the deterinination of kinds, quantities or concentrations, 30 and in some cases, the locations of radioactive material in the human body, 21 whether by direct measurement, in vdvo counting, or by analysis and evaluation
_22 of materials excreted or removed from the human body. For purposes of.these ,
23- rules, a radiobioassaya is an equivalent term.
24 *Boarda means the Radiation Control Board created under Section 19+1-106.
25
- Byproduct materiala means:
y -26 (a) a radioactive < material, with the exception of special nuclear 27 material, yielded in or made radioactive by exposure to the radiation incident 28' to the process of producing or utilizing special nuclear material; and
, 3
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1 (b) the tailings or wastes produced by the extraction or concentration of 2 uranium or thorium from any ore processed primarily for its source material 3 content, including discrete surface wastes resulting from uranium or thorium 4 solution extraction processes. Underground ore bodies depleted by these solution 5 extraction operations do not constitute
- byproduct material
- within this 6 definition.
h op- h 7
- Calendar quarter" means not less than 12 consecutive weeks nor more than 8 14 consecutive weeks. The first calendar quarter of the year shall begin in ;
9 January, and subsequent calendar quarters shall be arranged so that no day is 10 included in more than one calendar quarter and no day in any one year is omitted 11 from inclusion within a calendar quarter. (a li n;:n ;; .;i t x;t zi:11 :::
12 rh __.;; ti; nt:d ex;.;d by hi: :: d=; nini;; :s n d;; p :t::: f;; ;n;xx 13 cf tin; nl:: ;xx p ;; th: i;; inia; ;f : ni nd:: inc.]Iha.as.ehna nhaarvaa 14 by the licanmaa er realatrant for datarminina calendar suartera shall nniv be 15 chansaa at the baainnina of a vaar.
16- " Calibration" means the determination ofi 17' (a) the response or reading of an instrument relative to a series of known 18 radiation values over the range of the instruments or 19 (b) the strength of a source of radiation relative to a standard.
20 *CFR" means Code of Federal Regulations.
21 " Chelating agent" means a chemical ligand that can form coordination
-22 compounds in which the ligand occupies more than one coordination position. The 23 agents include beta diketones, certain proteins, amine polycarboxylic acida, 24 hydroxycarboxylic acids, gluconic acid, and polycarboxylic acids.
25- " Collective dose" means the sum of the individual doses received-in a given 26 period of time by a sr+ :ified population from exposure to a specified source of
- 27. radiation.
28
- Committed dose equivalent" (Hue) , means the dose equivalent to organs or 4
e r e 1 tissues of reference (T), that will be received from an intake of radioactive 2 mr.terial by an individual during the so year period following the intake.
3 " committed effective dose equivalent" (%,n), is the sum of the products 4 of the weighting factors applicable to each of the body organs or tissues that 5 are irradiated and the committed dose equivalent to each of these organs or 6 tissues.
7 " controlled arena means an area, outside of a restricted area but inside 8 the site bourdary, access to which can be limited by the licensee or registrant 9 for any reason.
10 " curie" means a unit of measurement of ( d.i ::tivitylactivitv. One curie L 11 (ci) is that quantity of radioactive material which decays at the rate of 3.7 x 12 10" disinteorations or _transfor. nations per se:ond (dpn or tps) .
13
- Deep dose eqMvalent" (N), which applies to external whole body exposure, 14 means the dose equivalent at a tissue depth of one centimeter (1000 mg/cm ) . 3 15 " Department" means the Utah state Department of Environmental Quality.
16 " Depleted uranium
- means the source material uranium in which the isotope 17 uranium-235 is less than 0.711 weight percent of the total uranium present.
18 Depleted uranium does not include special nuclear material.
19 " Dose" is a generic term that means absorbed dose, dose equivalent, 20 effective dose equivalent, committed dose equivalent, committed effective dose 21 equivalent, or total effective dose equivalent. For purposes of these rules, 22 " radiation dose" is an equivalent term.
23 " Dose equivalent" (H,) , means the product of the absorbed dose in tissue, 24 quality factor, and other necessary modifying factors at the location of 25 interest. The units of dose equivalent are the sievert (Sv) and rem.
2G " Dose limits" means the permissible upper bounds of radiation doses !
27 established in accordance with these rules. For purpose of these rules, " limits" l
28 is an equivalent term. l 5
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1 " Effective dose equivalent" (H,), means the sum of the products of the dose 2 equivalent to each organ or tissue (H.) , and the weighting f actor, (w ,) ;
3- applicable to each of the body organs or tissues that are irre.diated. .I 4 " Embryo / fetus" means the developing human organism from conception until 5 the time of birth, 6 " Entrance or access point" means an opening through which an individual or 7 extremity of an individual could gain access to radiation areas or to licensed I t 8 or registered radioactive materials. This includes entry or exit portals of ;
9 sufficient size to permit human entry, irrespectiva of their intended use.
2 10 " Executive secretary" means the executive secretary of the board.
11 " Explosive material" means a chemical compo ad, mixture, or device which
~
12 produces a substantial instantaneous release of gas and heat spontaneously or_by ,
13 contact with sparks or flame, e
14_ " EXPOSURE" when capitalized, means the quotient of dQ by dm where "dQ" is 15 the absolute value of the-total charge of the ions of one sign produced in air 16- . when all the electrons, 1,oth negatrens and positrons, liberated by photons in a
, 17- volume element of air having a mass of adm" are completely stopped in air. The
-18 special unit of EXPOSURE is the roentgen (R) . See R313 12-20 Units of exposure 19 and dose for the SI equivalent. For purposes of these rules, this term is used 20 as e noun.
21- " Exposure" when not capitalised as the above term, means being exposed to 4
.32 ionizing radiation or to radioactive material. For purposes of these rules, this '
.33 term is used as a verb.
24- ' "EXPOSURE rate" means the EXPOSURE per unit of time, such as roentgen per 4
i- 25 minute and mil 11 roentgen per hour.
26 "E:;ternal dose" means that portion of the dose equivalent received from a 27 source of radiation-outside the body.
. 28 " Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg 6
. t 1 below the knee.
2 " Eye dose equivalent" meano the external dose equivalent to the lens of the 3 eye at a tissue depth of 0.3 centimeter (100 mg/cm ) . 8 4 "Former United States Atomic Energy Commission (AEC) or United Stats-5 Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, 6 nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass 7 experimental facilities where AEC or NRC licenses have been terminated.
ll[ 8 " Generally applicable environmental radiation standards" means standards 9 issued by the U.S. Environmental Protection Agency under the authority of the I11 10 Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the 12 general environment outside the boundaries of locations under the control of 13 persons possessing or using radioactive material.
14 " Gray" (Gy) means the SI unit of absorbed dose. One gray is equal to an 15 absorbed dose of one joule per kilogram.
16 " Hazardous waste" means those wastes designated as hazardous by the U.S.
17 Environmental Protection Agency rules in 40 CFR Fart 261.
18 " Healing arts" means the disciplines of medicine, dentistry, osteopathy, 19 chiropractic, and podiatry.
20 "High radiation area" means an area, accessible to individuals, in which 21 radiction levels could result in an individual receiving a dose equivalent ia 12 excess of one mSv (0.1 rem), in one hour at 30 centimeters from a source of 23 radiation or from a surface that the radiation penetrates. For purposes of these 24 rules, rooms or areas in which diagnostic x-ray systems are used for healing arts 25 purposes are not considered high radiation areas.
26 " Human use" means the intentional internal or external administration of 27 radiation or radioactive material to human beings.
28 [ "nC" :: n irc stigstory n u drug for which an x mption h:: b :n clai=::
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1 und:r th; Unit;d Otet;; reed, 0;;; :nd 0;;;;ti; ';t.) .
2 " Individual" means a human being.
3 " Individual monitoring" means the assessment ot's 4 (a) dose equivalent, by the use of individual monitoring devices or, by 5 the use of survey data; or 6 (b) committed effective dose equivalent by bioassay or by determination 7
of the time weighted air concentrations to which an individual has been exposed, 8 that is, DAC-hours.
9
" Individual monitoring devices" means devices designated to be worn by a 1C single individual for the assessment of dose equivalent. For purposes of these 11 rules, individual monitoring equipment and personnel monitoring equipment are 12 equivalent terms.
Examples of individual monitoring devices are film badges, 13 thermoluminescent donimeters (TLD's), pocket ionization chambers, and personal 14 air sampling devices.
15 " Inspection" means an of ficial examination or cbservation including, but 16 not limited to, tests, surveys, and monitoring to determine compliance with 17 rules, orders, requirements and conditions applicable to radiation sources.
18 " Interlock" means a device arranged or connected requiring the occurrence 19 of an event or condition before a second condition can occur or continue to 20 occur.
21 " Internal done" means that portion of the dose equivalent received from 22 radioactive material taken into the body.
23 " License" means a license issued by the Executive Secretary in accordance 24 with the rules adopted by the Board.
25 " Licensee" means a person who is licensed by the Department in accordance 26 with these rules and the Act.
27 " Licensed or registered material" means radioactive material, received, 28 possessed, used or transferred or disposed of under a general or specific license 8
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1 'issued by the Executive Secretary, 2 " Licensing state" means a state which has been nrovisionally or finally 3 denianated am such by the conference of Radiation control Procram Directorm.
4 Inc. which reviews sta_te reaulations to establish eauivalency with the suaoested 5
state Reaulations and ascertains whether a State has an effective n_ roc _ ram for 6 control of natural occurrina or accelerator produced radioactive material (NARM).
7 The conference will denianate am Liennaina states those states with reaulations
, 8 for control of radiation relatina to. and an effective orocram for. the 9 reaulatorv control of NARM.[uitt rul;; g;iv;1;;t t; th: 0:33::::d .-Gtete 10 ::gul:tica; f : 0:ntr:1 :: n:distion :1; ting ::, 2nd :n effective pr:gr:- for,
, 11 the ::gul . cry : ntr:1 cf :"."". :nd which h:: h: n grant:d fin:.1 d: ignation hy 12 th: 0 nf;;;;;; cf n:disti n 0:ntr:1 "r;;;;; Oir::ters, Inc.)
13 " Limits". See " Dose limits",
e aoy3- M 14 " Lost or missing (lic;ns;d er r gister:d 2;;;i:1)mource of radiation" Y 15 means licensed or registered !=t:ri:1)mources of radiation whose location is MMi t
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.16 unknown. This definition includes. but is not limited to. (lic;;;;d er J
, s , a mirkbug w 17 ::gisterd)$mmmmeni sagendiiO that has been shipped but has not reached its
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18 planned destination and whose location cannot be readily traced in the 19 transportation system.
-20 " Major processor" means a user processing, handling, or manufacturing 21 radioactive material exceeding Type A quantities as unsealed sources or material,
.22 or exceeding four times Type B quantities as sealed sources, but does not include 23 nuclear medicine programs, universities, industrial radiographers, or small 24 industrial programs. Type A and B quantities are defined in 10 CFR 71.4.
25 " Member of the public" means an individual excent when that individual in 26 r.eceivina an occunational done.[in:A atr:11:d :: u.r: strict:d cres. n x;ver, 27 :n individual is not ; vc;&r :: th: puhlic during p;ried ir which the 28 indi;id::1 rc :iv : :n :: cup tion:1 d;;: . )
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1 " Minor" means an individual less than le years of age.
2 " Monitoring" means the measurement of radiation, radioactive material 3 concentrations, surface area activities or quantities of radioactive material, 4 and the use of the results of these measurements to evaluate potential exposures 5 and doses. For purposes of these rules, radiation monitoring and radiation 6 protection monitoring are equivalent terms.
7 "NARM" means a naturally occurring or accelerator-produced radioactive 8 material. It does not include byproduct, source or special nuclear material.
9 " NORM" means a naturally occurring radioactive material.
10 " Natural radioactivity" means radioactivity of naturally occurring 11 nuclides.
12 (- "NDA" ::;n: Meu Orug Applicati:n which h:2 b :n submitt:0 :: th; "nited 13 state; ro d and Orug administrati n.)
14
" Nuclear Regulatory Commission" (NRC) means the U.S. Nuclear Regulatory 15 Commission or its duly authorized representatives.
16 h [
" occupational dose" means the dose received by an individual (- in ;
i 17 :::tricted are; c r] in the course of employment in which the individual's 18 assigned duties for the licennee or reoistrant involve exposure to sources of 19 radiation, whether or not the sources of radiation are in the possession of the 20 licensee /*registranty or other person. Occupational dose does not include dosen 21 received [t] f rom background radiation, (;; ; p; tic .t .r;:: :di;;l pr;; tic c,]from 22 any medical administration the individual han received. from exnosure to 23 individuals administered radioactive material and released in accordance with 24 R313-32 *?S from voluntary participation in medical research programs, or as a 25 member of the public.
26 " Package" means the packaging together with its radioactive contents as 27 presented for transport.
10
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4 1 " Particle accelerator" means a machine capable of accelerating electrons, 2 protons, deuterons, or other charged particles in a vacuum and of discharging the s
3 resultant particulate or other radiation into a medium at energies usually in j 4 excess of one Mev.
'5 " Person" means an individual, corporation, partnership, firm, association, 6 trust, estate, public or private institution, group, agency, political 7 subdivision of this state, or another state or political subdivision or agency 8 thereof, and a legal successor, representative, agent or agency of the 9 foregoing [, but d;;; :t includ; f;du;l ;;c;;- unt egenes ) .
10 " Personnel monitoring equipment," see individual monitoring devices.
11 " Pharmacist" means an individual licensed by this state to practice 12 pharmacy. See sections 58-17-1 through 58-17-27.
I 13- " Physician" means an individual licensed by this state to practice medicine 14 and surgery in all its branches. See Sections 50-12-26 through 58-12-43, 15 " Practitioner" means an individual licensed by this state in the practice 16 of a healing art. Examples would be, physician, dentist, podiatrist, osteopath, 17 and chiropractor. #No /d k 18 v
- Protective anron manna an aeron made of radiation-attenuatino materials 19 used to reduce exnonure to radiation. -
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'20 f /
"Public dose" means the dose received by a member of the public from
, 21 (;;;;;;r; :: ;;;;;;; ;f ::dicti;n ;ith;r within ; li;;n;;;'; ;r r;5 i ctr;;t's 22' ;;;tr:11;d ;;;; Or ir u.r;;tri;t;d ;r;;;)mources of radiation from licensed ad W 23 {f " ' ' O lonerations. [h]Public done does not include occupational dose (T) QI /-
24 desea received from background radiation, (dx; r;;;ind ;; ; p;ti;nt f r; .-
3 25 :.;.di;;l p;;;ti;;;,)from any medical administration the individual han received.
26 from ernosure to individuals administered radioactive material and released in 27 accordance with R313-32-75. or (deee-] from voluntary participation in medical
. 28 research programs.
11
, i l - m t ;p /o C F R 1
y "Pyrophoric [ lipid or ;; lid or ;;;) material" means (; cdst; .;;)gw licuid 2 that ignites spontaneously in dry or moist air at or below 130 degrees Fahrenheit 3 (54.4 degrees Celsius) or any solid material. other than one classed a g.,_gn 4
ernlosive. which under normal conditions in liable to cause fires through 5
friction. retained heat from manufacturino or nrocessino. or which can be ionited 6 and. when ionited, burns so vicerousiv and nersistentiv as to crerre a serious 7 trannnertation. handlina. or disnosal hazard. Included are anontaneousiv 8 combustible and water-reactive materials.
9
" Qualified expert" means an individual having the knowledge and training 10 to measure ionizing radiation, to evaluate safety techniques, and to advise 11 regarding radiation protection needs, for example, individuals certified in the 12 appropriate field by the American Board of Radiology or the American Board of 13 Health Physics, or those having equivalent qualifications. With reference to the 14 calibration of radiation therapy equipment, an indivioual having, in addition to 15 the above qualifications, training and experience in the clinical applications 16 of radiation physics to radiation therapy, for example, individuals certified in 17 Therapeutic Radiological Physics or X-Ray and Radium Physics by the American 18 Board of Ra!iology, or those having equivalent qualifications.
19 " Qual!cy factor" (Q) means the modifying factor, listed in Tables 1 and 2 20 of R313-12-20 that is used to derive dose equivalent from absorbed dose.
21 " Rad" means the special unit of absorbed dose. One rad is equal to an 22 absorbed dose of 100 erg per gram or 0.01 joule per kilogram 23
" Radiation" means alpha particles, beta particles, gamma rays, x-rays, 24 neutrons, high speed electrons, high speed protons, and other particles capable 25 of producing ions. For purposes of these rules, ionizing radiation is an 26 equivalent term. Radiation, as used in these rules, does not include non-27 ionizing radiation, like radiowaves or microwaver, visible, infrared, or 28 ultraviolet light.
12
. b c
1 " Radiation area" means an area, accessible to individuals, in which
- 2. radiation levels could result in an individual receiving a dose equivalent in 3 excess of 0.05 mSv'(0.005 rem), in one hour at 30 centimeters from the source of 4- radiation or from a surface that the radiation penetrates.
5 " Radiation machine" means a device capable of producing radiation except _
6 those devices with radioactive material as the only source of radiation. [g dd 7 " Radiation safety of r" means an individual who has the knowledge and 8 responsibility to apply appropriate radiation protection rules and han been 9 amnioned much responsibility by the licennae or resistrant.
10 " Radiation source." See " Source of radiation."
11 " Radioactive material" means a solid, liquid, or gas which emits radiation 12 spontaneously.
13 " Radioactivity" means the transformation of unstable atomic nuclei by the 14 emission of radiation.
15 "Radiobioassay". See " Bioassay".
16 " Registrant" means any person who is registered with respect to radioactive 17 materials- or radiation machines with the Executive Secretary or is legally 18 obligated to register with the Executive Secretary pursuant to these rules and
- 19 the Act.
20 " Registration" means registration with the Department in accordance with 31 .the rules adopted by the Board.
22 " Regulations of the U.S. Department of Transportapion" means 49 CFR 100 23 through 1 .
h %8 24 " Rem" means the special unit of any of the quantities expressed as dose 25 equivalent. The dose equivalent in rem is equal to the absorbed dose in rad 26 multiplied by the quality factor. One rem equals 0.01 sievert (sv) 27 "Research and development" means:
28 La) theoretical analysis, exploration, or experimentation or 13 i l
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6 1 .(b) the extension of investigative findings and theories of a scientific 2 or technical nature into practical application for experimental and demonstration 3 purposes, including the experimental production and testing of models, devices, 4 equipment, materials, and processes. Research and development does not include 5-the internal or external administration of radiation or radioactive material to 6 human beings.
-7 " Restricted area" means an area, access to which is limited by the licensee-8 or registrant for the purpose of protecting individuals against undue risks from 9 exposure to sources of radiation. A " Restricted area" does not include areas
! 10 used as residential quarters, but separate rooms in a residential building may 11 be set apart as a restricted area.
12 " Roentgen" (R) means the special unit of EXPOSURE. One roentgen equals 0
13 2.5B x lo
- coulombs per kilogram of air, ree EXPO 3URE. 30 Jeg g
14 r
" Sealed source" means (r:dicactin =teri:1 that i: p;r= nntly isnd:d ::
w.3 l 15 fined ir ; ::p:ul: cr =trin d::ign d :: pnnat nl:n: and di:pu ni sf th 16 ndin ctin =teri:1 undu 'h n: nun unditi n: uhich n likely :: b; 17 :n :unt:nd in n:=:1 u:: and handling.)any con t a i ne r o f GA MEIM* ===== ta d 18 which han been constructed in much a manner as to erevent the emenne of anv 19 vad4 ssFEWe*nanteria C*$
20 " Shallow dose equivalent" (H,) which applies to the external exposure of 21 the skin or an extremity, means the dose equivalent at a tissue depth of 0.007 22 centimeter (seven mg per em ), averaged over an area of one square centimeter.
3 23 "SI" means an abbreviation of the International System of Units.
24 "Sievertr (SV) means the SI unit of any of the quantities expressed as dose 25 equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray 26 multiplied by the quality factor, one Sv equals 100 rem.
27 " Site boundary" means that line beyond which the land or property is not 28 owned, leased, or otherwise controlled by the licensee or registrant.
14
41 "ccepg } M /s(Ff 7/ A m -
pe k h 1 "Bource container" manna a device in whi ch samlad sources are ' tranneerted 2 or storad'.
3 asource material" means:
4 (a) uranium or thorium, or any combination thereof, in any physical or
-5 chemical form, or 6 (b) ores that contain by weight one-twentieth of one percent (0.05 7- percent), or more of, uranium, thorium, or any combination of uranium and 8- thorium. Source material does not include special nuclear material.
9 " source material milling" means any activity that results in the production 1
10 of byproduct material as defined by (b) of ' byproduct material".
11 " source of radiation" means any radioactive waterial, or a device or 12 equipment emitting or capable of producing ionizing radiation.
13 "special form radioactive material" .means radioactive material which
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14 satisfies the following conditions:
15 (a) it is either a single solid piece or is contained-in a sealed capsule 16 that can be opened only by destroying the capsule; 17 (b) the piece or capsule has at least one dimension not J ess than five
-18 millimeters (0.197 inch); and 19 (c) it satisfies the test requirements specified by the U.S. Nuclear 20 Re;, latory Commission. A special form encapsulation designed in accordance with 21 the U.S. Nuclear Regulatory Commission requirements in effect on June 30, 1983, 22 and constructed prior to July 1, 1985, may continue to be used. A special form 23 encapsulation either designed or constructed after June 30, 1985, shall meet 24 requirements of this definition applicable at the time of its design or 25 construction.
26 aspecial nuclear materiala means:
27 (a) plutonium, uranium-233, uranium enriched in the isotope 233 or in the 28 isotope 235, and other material that the U. S . Nuclear Regulatory Commission, 15
.- i .
G.
4 l
1 pursuant to the provisions of section bl of the Atomic Energy Act of 1954, as 2 amended, determines to be special nuclear material, but does not include source 3 materials or 4 (b) any material artificially enriched by any of the foregoing but does 5 not include pource material.
6 "special nuclear material in quantities not sufficient to form a critical 7 mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 8
grams of contained U-235; uranium-233 in quantitieb not exceeding 200 grams; 9 plutonium in quantities not exceeding 200 grams or a combination of them in 10 accordance with the following formula: For each kind of special nuclear 11 material, determf ,e the ratio between the quantity of that special nuclear 12 material and the quantity specified above for the same kind of special nuclear 13 -material. The sum of such ration for all of the kinds of special nuclear 14 material in combination shall not exceed one. For example, the following 15 quantities in combination would not exceed the limitation and are within the 16 formula:
17
((175(Grams contained U-235) /350) + (50(Grams U-233/200) + (50 (Grama
'18 Pu) /200) ) is equal to one.(
19 :: ::: ::;t:.in::" :: : : :.i:: ir uhi:t :::1:e :::::;; ::: :::n:p:. ::d 20 :: :::::d.)
21 " Survey" means an evaluation of the radiological conditions and potential 22 hazards incident to the production, use, transfer, release, disposal, or presence 23 of sources of radiation. When appropriate, such evaluation includes, but is not 24 limited to, tests, physical examinations and measurements of levels of radiation 35 or concentrations of radioactive material present.
26 " Test" means the process of verifying compliance with an applicable rule.
27 "These rules" means " Utah Radiation Control Rules".
28 " Total effective dose equivalent" (TEDE) means the sum of the deep dose 16
c20.b /06 h
1 equivalent for external exposures and the committed effective ivalent for 2 internal exposures, j0 b
3
- Total orcan dome eauivalent" (TODE) menna the sum of the deen done [
4 gauivalent and the committed done eauivalent to the oroan receivino the hiahent 5 done an a==cribed in R313-is-iio? (i) (fl .
6 "U.S. Department of Energy" means the Department of Energy established by 7 Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the 8 extent that the Department exercises functions formerly vested in the U.S. Atomic 9 Energy Commission, its Chairman, members, officers and components and transferred 10 to the U.S. Energy Research and Development Administration and to the 11 Administrator thereof pursuant to sections 104 (b) , (c), and (d) of Public Law 12 93-438, October 11, 1974, BB Stat. 1233 at 1237, effective January 19, 1975 known 13 as the Energy Reorganization Act of 1974, and retransferred to the Secretary of 14 Energy pursuant to section 301(a) of public Law 95-91, August 14, 1977, 91 Stat.
15 565 at 577-570, 42 U.S.C. 7151, ef fective October 1,1977 known as the Department 16 of Energy Orgat.1tation Act, 17 " Unrefined and unprocessed ore" means ore in its natural form prior to 18 processing, like grinding, roasting, beneficiating or refining.
19 " Unrestricted area" means an area, to which access is neither limited nor 20 -controlled by the licensee or registrant. For purposes of these rules, 21 " uncontrolled area" is an equivalent term.
22 " Waste" means those low-level radioactive wastes that are acceptable for 23 disposal in a land disposal facility. For the purposes of this definition, low-24 level waste has the same meaning as in the Low-Level Radioactive Waste Policy 25' Act, P.L.96-573, as amended by P.L.99-240, effective January 15, 1986; that is.
26 radioactive waste:
27 (a) not classified as high-level radioactive waste, spent nuclear fuel, or 28 byproduct material as defined in Section 11e. (2) of the Atomic Energy Act 17 l
.,-V ,
J 4
1 (uranium or thorium tailings and waste) and
- 2. (b) classified by the U.S. Nuclear Regulatory Commission as low-level 3 radioactive waste consistent with existing law and in accordance with (a) above.
4 " Waste collector licensees" means persons licensed to receive and store 5' radioactive wastes prior to disposal or persons licensed to dispose of 6- radioactive waste.
7 " Week" means seven consecutive days starting on Sunday.
8 "Whole body" means, for purposes of external exposure, head, trunk 9 including male gonads, arms above the elbow, or legs above the knees.
9 10 " Worker" means an individual engaged in work under a license or 11 registration issued by the Executive Secretary and controlled by a licensee or 12 registrant, but does not include the licensee or registrant.
13 " Working level" (WL), means any combination of short-lived radon daughters 14 in one liter of air that will result in the ultimate emission of 1.3 x 105 MeV' 15 of potential alpha particle energy. 'The short-lived radon daughters are, for 16 raden-222 polonium-218, lead-214, bismuth-214, and polonium-214; and for radon 17 220: polonium-216, lead-212, bismuth-212,.and polonium-212. -
18 " Working level month" (WU4), means an exposure to one working level for 170 19 hours. 2,000 working hours per year divided by - 12 months per year is 20 approximately equal to 170 hours0.00197 days <br />0.0472 hours <br />2.810847e-4 weeks <br />6.4685e-5 months <br /> per month, r h4[gj,q l
21 " Year" means the period of time beginning in January used to determine 22 compliance with the provisions of these rules. The licensee orfregistrant may 23 change the starting date of the year used to determine compliance by the licensee 24 torf regist' rant?provided that eha decinion to make the change is made not later
~
25 = than necember ai er the crevioun tat the h;3 i nning c' th;) year. If a licensee 26 N " M E M D chances in a vear. the lictnmee 7r$5AEFaEE mhall annure (--emd) 27 that no day is omitted or duplicated in consecutive years.
28 18
_. _ _ ,. ~.- __ _ . __ _ . - , . . . . . _ . . . . - . _ _ _ .. _ _ -
.y..
'O
.o
. 1 R313-12-20.- Units of Exposure and Dose.
2 (1) As used in these rules, the' unit of EXPOSURE is the coulomb per 3 kilogram (c per kg). one roentgen is equal'to 2.58 x 104 coulomb per kilogram 4 'of air.
5- (2) As used in these rules, the units of dose are:
6 (a) Gray. (Gy) is the SI unit of absorbed dose, one gray is equal'to an 7 . absorbed dose of one joule per kilogram. one gray equals 100 rad.
- 8- (b) -Rad is the special unit of absorbed dose. One rad-is equal to an
.9 ' absorbed dose of 100 erg per gram or 0.01 joule per kilogram. -one rad equals 10 0.01 Gy.
l 11 (c) Rem is the special unit of eny of the quantities expressed as dose 12 equivalent. The dose equivalent-in rem is equal to the absorbed dose in rad
-13 multiplied by the quality factor, one rem equals 0.01 Sv.
14 .(d) Sievert (SV) is the SI unit of any of the quantities expressed as dose 15 . equivalent. :The dose equivalent in sievert is equal to the absorbed dose in gray 16 multiplied by the quality factor. One sv equals 100 rem.
17 .(3) As used in these rules, the quality factors for converting absorbed 18- dose to dose equivalent are shown in Table 1.
4 19-Y 19
. P
- 4 1
2 TABLE 1 3
4 Quality Factors and Absorbed Dose Equivalencies 5
6 Absorbed Dose 7 Equal to a 8 Qual _cy Unit Dose 9 Type of Radiation Factor (Q) Equivalent 10 11- X, gamma, or beta radiation and 1 1 12 high-speed electrons I 13 Alpha particles, multiple-charged 20 0.05 l.
l 14 particles, fission fragments and 15 heavy particles of unknown charge 16 Neutrons of unknown energy 10 0.1 17 High energy protons 10 0.1
-18 19 For the column in Table 1 labeled " Absorbed Dose Equal to a Unit Dose 20 Equivalent", the absorbed dose in rad is equal to one rem or the absorbed dose 21 in gray is equal to one Sv.
22 23 (4) If it is more convenient to measure the neutron fluence rate than to 24 determine the neutron dose equivalent rate in sievert per hour or rem per hour, 25 as provided in R313-12-20 (3) , 0.01 Sv of neutron radiation of unknown energies 26 may, for purposes of these rules, be assumed to result from a total fluence of 27 25 million neutrons per square centimeter incident upon the body. If sufficient I
28 information exists to estimate the approximate energy distribution of the 20
, -- p . .
1 neutrons, the licensee'or-registrant may use'the' fluence rate per unit dose 2 equivalent or the appropriate Q value from Table 2 to convert a measured tissue 3 dose in gray or. rad to dose equivalent in sievert or rom.
4 5'
I 21
. C .
J 1 TABLE 2 2
3 Hean Quality Factors, Q, and Fluen:>s Per Unit Dose 4 Equivalent for Monoenergetic Neutrons 5
6 Fluence per Fluence per 7 Unit Dose Unit Dose 8 Neutron Quality Equivalent Equivalent 9 Energy Factor neutrons neutrons 10 Mev o em 2 rem' em
- sv 2 11 12 thermal 2.5 x 10' 2 980 x 105 980 x 10' 13 1 x 10 ' 2 980 x 10' 980 x 108 14 1 x 10-' 2 810 x 10' 810 x 10' 15 1 x 105 2 a10 x 10' 810 x 10' 16 1 x 10* 2 840 x 105 840 x 108 17 1 x 102 2 980 x 10' 980 x 108 18 1 x 10 2 2.5 1010 x 105 1010 x 10' 19 1 x 101 7.5 170 x 10' 170 x 108 20 5 x 10t 11 39 x les 39 x 10' 21 1 11 27 x 105 27 x 10' 22 2.5 9 29 x 108 29 x 10' 23 5 8 23 x 10' 23 x 10' 24 7 7 24 x 108 24 x 10' 25 10 6.5 24 x 10' 24 x 10' 26 14 7.5 17 x 105 17 x 10' 27 20 8 16 x 10' 16 x 10' 28 40 7 14 x 10' 14 x 10' 22
. P .
c' 1 60 5.5 16 x 108 16 x 108 2 1 x 10' 4 20 x 105 20 x 10' 3 -2 x 108 3.5 19 x 108 19 x 10' 4 3 x 108 3.5 16 x 108 16 x 10' S 4 x 108 3.5 14 x 10' 14 x 10' 6
7- For the column in Table 2 labeled " Quality Factor", the values of Q are at 8- the point where the dose equivalent is maximum in a 30 cm diameter cylinder
-9 tissue-equivalent phantom.
10 For the columns in Table 2 labeled " Fluence per Unit Dose Equivalent", the 11 values are for moneenergetic neutrons incident normally on a 30 cm diameter l
12 cylinder tissue equivalent phantom.
13 14 R313-12-40. Units of Radioactivity.
I 15 For purposes of these rules, activity is expressed in the SI unit of 16 becquerel (Bq), or in the special unit of curie (C1), or their multiples, or
~17 disintegrations or transformations per unit of time.
18 (1) one becquerel (Bq) equals one disintegration or transformation per 19 second.
20 (2) One curie (ci) equals 3.7 x 10" disintegrations or transformations 21 per second, which equals 3.7 x 10" becquerel, which equals 2.22 M8 10 22- disintegrations or transformations per minute, hffa Y /0Cf ho'sI
, O $ h(
24 R313-12-51. Records. m V U 25 (1) A licensee or registrant shall maintain records showing the receipt, 26 transfer, and disposal of all sources of radiation.
27 (2) Prior to licenne termination. each licennee authorized to nossess
-28 radioactive material with a half-life creater than 12 0 days . in an unnealed form.
23
.-(. .
.. 3 0. 51 - '
1 .mav forward tha followina racoram to the avaeutive secretarv, 2 fa) racoram of dianomal of lican=ed materini made undar m313-is-ioo2 ,y, l0W'D \-
3 fincludina burials authnrized before January 2a. 1981). m313-is-ioo3. R 13-is. [ d 4' 1004. m313-is-loosr and g
g[
5- (b) records reauired bv m313-is-11o3f2)fd). p 6 goTur io crn 20. 304 normitted burial of amm11 ouantities of lican=ad 7 ' materials in meil- before January 2a. 1981. withmut' anecific U.s. Nuclem 8 neaulatorv corr a4 maion aucharimation. see 20.304 contained in the io crn. narta
.9 o to 199. edition revised an of Januarv 1. 1991.
10 (3)
If licanned activities are tran=ferred or amnioned in accordance with
-11 R313-19-34 (2 ) . each lienn=ee authnrized to nommean radioactive material. with a I
.12 _ half-life arenter than 120 dava. in an' un=maled form. = hall tran=fer rh l 13 t followine records to cha new 11can==='and'cha new lican=ee will be reannnaible !
i 14 for matntainino chase recorda until the licanae in terminated, 15 fa) records of dianomal of licanned materini made under
- 16. mais-is-ioo2]I finclud4no buriala mucharized before Januarv na. 19si). n313-is-ioo3. m313-is . .
17 1o04. m313-is-loost and
-18 (b) records reauired bv m313-is-iio3 (2) id) .
19 (4) prior to lican=e termination. each lican=me may forwqd the records 20 reouired bv m313-22-3s(7) to cha nxmeutive secretarv.
21- f5) Additional records requirements are specified elsewhere in these 22- rules.
'23
-24 ,R313-12 52. Inspections.
25 (1) A licensee or registrant shall afford representatives of the Executive 26 secretary, at reasonable times, opportunity to inspect sources of radiation and 27 the premises and facilities wherein those sources of radiation are used or 28 stored.
24
e P.
1 (2) A licensee or registrant shall make available to representatives of 2 the Executive Secretary for inwpection, upon reasonable notice, records 3 maintained pursuant to these rules.
4 5 R313-12-53. Tests.
6 (1) A licensee or registrant shall perform upcn instructions from a 7 representative of the Board or the Executive Secretary or shall permit the
, 8 representative to perform reasonable tests as the representative deems l 9 appropriate er necessary including, but not limited to, tests of:
10 (a) rources of radiation;
! 11 (b) facilities wherein sources of radiation are used or stored; 1
1 l 12 (c) radiation detection and monitoring instruments; and 13 (d) other equipment and devices used in connection with utilization or 14 storage of licensed or registered sources of radiation.
15 16 R313-12-54. Additional Requirements.
17 The Board may, by rule, or order, impose upon a licensee or registrant 18 requirements in addition to those established in these rules that it deems 19 appropriate or necessary to minimize any danger to public health and safety or 20 [p;sperty)the environment, t
21 22 R313-12-55. Exemptions.
23 (1) The Board may, upon apt.lication or upon its own initiative, grant 24 exemptions or exceptions from the requirements of these rules as it determines 25 are authorized by law and will not result in undue hazard to public health and 26 safety or [ prop;rty]the environment.
27 (2) U.S. Department of Energy contractors or subcontractors and U. S .
28 Nucleat Regulatory Commission contractors or subcontractors operating within this 25
. p.
r 6
i 1 state are exempt from these rules to the extent %at the contractor or )
2 I subcontractor under his contract receives, pasaesses, uses, . transfers, or J 3 acquires sources of radiation. The fellowing contractor categories are included
- 4 (a) l prime contractors performing work for the U.S. Department of Energy-5 at U.S. Government-owned or controlled sites, including the transportatios. of 6 sources of radiation to or from the sites and ;;he performance of contract 7 services during temporary interruptions of the transportation B
(b) prime contractors of the U.S. Department of Energy performing research 9 in, or development, manufacture, storage, testing or transportation of, atomic 10 weapons or components thereof; 11 (c) prime contractors of the U.S. Department of Energy using or operating 12 nuclear reactors or other nuclear devices in a United States Government-owned 13 vehicle or vessels and 14 (d) any other prime contractor or subcontractor of the U.S. Department of 15 Energy or of the U.S. Euclear Regulatory Commission when the state and the U.S.
16 Nuclear Regulatory Commission jointly determine (1) that the exemption of the 17 prime contractor or subcontractor is authorized by lawi and (ii) that under the 18 terms of the contract or subcontract, there is adequate assurance that the work 19 . thereunder can be accomplished without undue risk to the public health and 20 safety.
21 22 R313-12-70. Impounding.
23 Sources of radiation shall be subject to 1 pounding pursuant to Section 19-24 3-111 sq Persons who have a h_ ,g m m w - n mwem' ' af " m=M me d an *f r- r?= M arm " muh4 act ta1-- a 25 established in accordance with the Leoinlative Annronriations Act for the actual 26 cost of the manneement and oversicht activities nerformed by recrementatives of 27 the Executive Secretarv, 28 26 .
igk 6 o
- s 1 R313-12-100. Prohibited Fsea.
2 (1) A hand-held fluoroscopic screen using x-ray equipment shall not be 3
used unless it has been listed in the Registry of Sealed Source and Devices or 4
accepted for certification by the U.S. Food and Drug Administration, Center for 5 Devices and Radiological Health.
6 (2) A shoe-fitting fluoroscopic device shall not be used.
l
-7 8- R313-12-110. Communications.
-9 All communications and reports concerning these rules, and applications 10 filed thereunder, should be addressed to the Division of Radiation Control, P.O.
11 Box 144850, 168 North 1950 West, Salt Lake City, Utah 84114-4850.
12 13 KEY: definitions, units, inspections, exemptions 14 [211-- ri 10, 100711111 19-3-104 15 19-3-10s r
,_ v0 27
.. . -- -- ~
w
- f ~
d 1 (2) The licensee or registrant shall retain the records until the 2
Executive Secretary terminates each pertinent license or registration requiring 3 these records.
4
~
5 (m313-1811107.3 Records of Individual Monitoring Results.
6 (1) Recordkeeping Requirement. Each licensee or registrant shall maintain 7
records of doses received by all individuals for whom monitoring was required 8
pursuant to Section R313-15-502, and records of doses received during planned 9
special exporures, accidents, and emergency conditions. Assessments of dose 10 equivalent and records made using units in effect before January 1, 1994, need 11 not be changed. These records shall include, when applicable:
12 (a)
The deep dose equivalent to the whole body, eye dose equivalent, 13 shallow dose equivalent to the skin, and shallow doss equivalent to the 1 14 extremities; and i
l 15 (b)
The estimated intake of radionuclides, see Section R313-15-202; and 16 (c) The committed effective dose equivalent assigned to the intake of 17 radionuclides; and 18 (d)
The specific information used to calculate the committed effective 19 dose equivalent pursuant to Subsection R313-15-204 (3); and 20 (e) The total effective dose equivalent when required by Section R313 21 202; and 22 ~
(f).. : Thel total ~ of -the deep dose ' equivalent and thel. committed dose to then 23 organ.' receiving ; thC highest total ' 68mef.
24 (2)
Recordkeeping Frequency. The licensee or registrant shall make entries 25 of the records specified in Subsection R313-15-1107(1) at intervals not to exceed 26 one year.
27 (3)
Recordkeeping Format. The licensee or registrant shall maintain the 28 records specified in Subsection R313-15-1107 (1) on form DRC-06, in accordance 58
~ ., .
i
../
C/ 1 s
2 i with the in;tructions fer fcrm DRC-06, or in cl0 r and legiblo record 3 contcining 2 011 the information required by form DRC-06.
3 (4) The licensee or registrant shall maintain the records of dose to an The 4 cmbryo/f etus with the records of dose to the declared pregnant woman.
5 declaration of pregnancy, including the estimated date of conception, shall also 6 be kept on file, but may be maintained separately from the dose records.
7 (5) The licensee or registrant shall retain each required form or record 8 until the Executive Secre ary terminates each pertinent license or registration 9 requiring the record.
l10 l11 R313-15-1108. Records of Dose to Individual Members of the Public.
'12 (1) Each licensee or registrant shall maintain records sufficient to 13 demonstrate compliance with the dose limit for individual members of the public, i
14 See Section R313-15-301, 15 (2) The licensee or registrant shall retain the records required by 16 Subsection R313 110 B (1) until the Executive Secretary terminates each neauirements for 17 pertinent license or registration requiring the record, 18 dienonitien of these records. nrior to license termination. are located in 19- Section R313-12 51 for activities licensed under these rules.
20 21 R313-15-1109. Records of Waste Disposal.
22 (1) Each licensee or registrant shall maintain records of the disposal of 23 licensed or registered materials made pursuant to Sections R313-15-1002, R313 l 24- 1003, R313-15-1004, R313-15-1005, Rule R313-25, and disposal by burial in soil, 25 including burials authorized before January 20, 1981.
1 26 (2) The licensee or registrant shall retain the records required by 27 Subsection R313 1109 (1) until the Executive Secretary terminates each 28 pertinent license or registration requiring the record.
59 m
'AMt /%Acd Ayhtuns 83/3-32 c +s -
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' a. k 313 - Ja - IV, {\loIibcbicas, - Gbeyo b y to y Irae lo f 3I3-33-I9 (%h{a) hew $ Y h ofmh e. c axjeh N $3l3-39~l3(e){") _
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1 1 R313. Rnvironmental Quality, Radiation Control.
7 2 R313-32. Medical Use of Radioactive Meterial.
3 R313-32-1. Purpose and Authority. --
4 (1) The purpose of this rule is to prescribe requirements and provisions 5 for the medical use of radioactive material and for issuance of specific licenses 6 authorizing the medical use of this material. These requirements and provisions
-7 provide for the protection of the public health and safety. The requirements and 8 provisions of R313-32 are in addition to, and not in substitution for, other 9 sections of R313.
10 (2) The rules set forth herein are adopted pursuant to the provisions of
- 11. sections 19-3-104(3) and 19-3-104 (6) .
12 13 R313-32-2. Definitiosas .
( o 14
- Authorized nuclear charmacista means a charmacist who is; 15 fa) board certified as a nuclear charmacist by the Board of harmaceutical 16 seccialties:
17_, (b) identified as an authorized nuclear chamacist on a Nuclear Reculatorv 18 Commission or Acreement State license that authorizes the use of radiametive y 19 materfal?in the oractice of nuclear charmaevr or 20 (c) identified as an authorized nuclear charmacist on a nermit issued by
-21 a Nuclear Reculatory commission or Acreement State snecific licensee of broad 22 geope that is authorized to nermit the use of radi oact'ive 'inatarlai in the 23 eractice of nucienr charmaev.
2 "
or podiatrist who io.
h ).f N. Authorized user" means a physician, dentist, 5 f a)_ ard certified by at least ene of the boards listed in Paracrach (1)
/
26 .of R313-32-910. R313-32-920. R313-32-930. R313-32-940. R313-32-950. or R313 27 2101 28 (b) identified as an authorized user en a Nuclear Recuinterv Commission 1
1 or Aareement State license that authorizes -he medical une of rad 4An=tive#
2 *-material or 3 (c) identified as an authorized user on a eermit issued hv a Nuclear 4 Regulatory Commission or Agreement State seecific_ licensee of broad econe that V V V 5
la authorize (eld to nermit the medical use of radioactive material. /
V 6 " Brachytherapy source" means an individual sealed source or a manufacturer-7 assembled source train that is not designed to be disassembled by the user.
8
" Dedicated check source" means a radioactive source that is used to assure 9 the constant operation of a radiation detection or measurement device over 10 several months or years.
11
" Dental use" means the intentional external administration of the radiation 12 from radioactive material to human beings in the practice of dentistry in 13 accordance with a license issued by this state.
14
" Dentist" means an individual licensed by this state to practice dentistry. M/[
15 " Diagnostic clinical procedures manual" means a collection of written 16 i
proceduros that describes each method, other instructions, and precautions, by 17 which the licensee performs diagnostic clinical procedures; where each diagnostic 18 clinical procedure has been approved by the authorized user and includes the 19 radiopharmaceutical, dosage, and route of administration.
20 7 " Management" means the chief executive officer or that person's delegate.
21 " Medical institution" means an crganization in which several medical 22 disciplines are practiced.
23
" Medical use" means the intentional internal or external administration of 24 radioactive material, or the radiation therefrom, to eatients er human 25 [behge] research subiects [ir the practic; cf ;;dicin; in ;;;;rd n;; with ;
26 licence issued by thi Otetc]under the sticervision of an authorized user.
27 " Ministerial change" means a change that is made, after ascertaining the 28 applicable requirements, by persons in authority in conformance with the NOK 6d. f*m i
_ o
1 requirements and without making a discretiont.cy judgement about whether those 2 requirements should apply in the case at hand. ' ' Ob~~ *
~
3 "Misadministrktion" means the adminictration of:
k$f l
~.
(J[
4 (a) A radiopharmaceutical dosage greater than 1.11 MBq (30 uCi either ~
5 sodiur 'odide I-125 or I-131.
h' N ry 6 (i. involving the wrong (pctient) individual.
N or
- ? radiopharmaceutical(r]1 or 8
(ii) when both the administered dosage differs from the prescribed dosage 9 by more than 20 percent of the prescribed dosage and the difference between the 10 administra. . dosage and prescribed dosage exceeds 1.11 MBq (30 uCi) .
11 (b) A therapeutic radiopharmaceutical dosage, other than sodium iodide I-I j 12 125 or I-131:
13 (i) involving the wrong (pati:nt) individual, wrong radiopharmaceutical, 14 or wrong route of administrations or 15 (ii) when the administered dosage differs from the prescribed dosage by 16 more than 20 percent of the prescribed dosage.
17 (c) A gamma stereotactic radiosurgery radi~ation dose:
18 (i) involving the wrong (p;ti:ntlindividuni or wrong treatment site; or 19 (ii) when the calculated total administered dose differs from the total 20 prescribed dose by more than ten percent of the total prescribed dose.
21 (d) A teletherapy radiation dose:
22 (i) involving the wrong (pati:nt] individual, wrong mode of treatment, or 23 wrong treatment site; 24 (ii) when the treatment consists of three or fewer fractions and the 25 calculated total administered dose differs from the total prescribed dose by more 26 than ten percent of the total prescribed dose; 27 (iii) when the calculated weekly administered dose [i; 20 p;rc nt gr. : r 28 then] exceeds the weekly prescribed dose by 30 nercent or more of the weekiv V 3 i
. -. - - ~ ._.. . . .- -
c- ,
- 1. prescribed dosa; or.
2 (iv)- when the calculated total' administered dose differs from the total 3 prescribed dose by more than 20 percent of the total prescribed dose.
4 (e) .A brachytherapy radiation dose:
5 -(i)' involving the wrong (penent) 4ndividual, wrong radionuelide, or wrong 6 '. treatment site [r) lexcluding, for permanent implants, seeds that were implanted 7- in-the correct site-but migrated outside the treatment sitel; 8 (ii) involving a sealed source that is leaking; 9 (iii) when, for a temporary imp'. ant, one or more sealed sources are not 10 removed upon completion of the procedure; or d
11 (iv) when the calculated administered-dose differs from the prescribed 12 dose by more than 20 percent of the. prescribed dose.
13 (f) A diagnostic radiopharmaceutical dosage, other than quantities greater
15 (i) involving the wrong (p;ti:nt14ndividu=1, wrong radiopharmaceutical, 16 wrong route of administration, or when the administered dosage differs from the t
'17 prescribed dosage; and 1
18: (ii) when the dose to the (p;ti;;t)individum1 exceeds 0.05 Sv (five rems)
!19 effective dose equivalent or 0.5 sv (50 rems) dose equivalent to any individual 20 organ.
21_ " Mobile nuclear medicine service" mear the transportation and medical use 22 .of radioactive material.
23 " Output" means the exposure rate, dose rate, or a quantity related in a 24 known manner to these rates from a teletherapy unit for a specified set of
'23- expssure conditions.
- 26. " Pharmacist" meann an individual licanned by a State or Territory of the
-27 Unitad states. the District of columbia. or the commonwealth of Puerto Rico to
_28 nractice nhanum K
w
- p. Mw* A j <
e 1
- Podiatric use" means the intentional external administration of the 2 radiation from radioactive material to human beings in the practice of podiatry 3 in accordance with a license issued by this State.
4 *Podiatrista means an individual licensed by this state to practice 5 podiatry.
6 " Prescribed dosage" means the quantity of radiopharmaceutical activity as 7 documented:
8 (a) in a written directives or 9 (b) either in the diagnostic clinical procedures manual or in an 10 appropriate record in accordance with the directions of the authorized user for 11 diagnostic procedures.
12 " Prescribed dosea means:
13 (a) for gamma stereotactic radiosurgery, the total dose as documented in 14 the written directive; 15 (b) for teletherapy, the total dose and dose per fraction as documented 16 in the written directives or 17 (c) for brachytherapy, either the total source strength and exposure time 18 or the total dose, as documented in the written directive.
- 1) " Radiation Safety Of ficer" means the individual identified as the Ptediation
~
20 safety officer on a license issued by the Executi,e secretary. 1 s)./L 21 " Recordable event" means the administratien oft e[f _ oe gpp 22 (a) a radiopharmaceutical or radiation wichout a written directive where 23 a written directive is required:
24 (b) a radiopharmaceutical or radiation where a written directive is 25 required without daily recording of each administered radiopharmaceutical dosage 36 or radiation dose in the appropriate records 37 (c) a radiopharmaceutical dosage greater than 1.11 MBq (30 uCi) of either 28 sodium iodide I-125 or I-131 when both:
5
1 (il the administered dosage differs from the prescribed dosage by more 8 than ten percent of the prescribed dosage, and 3
(ii) the difference between the administered dosage and prescribed dosage 4 exceed 555 knq (15 uci);
5 (d) A therapeutic radiopharmaceutical dosage, other than sodium iodide I. 1 6
125 or I-131, when the administered dosage differs from the prescribed dosage by 7 more than ten percent of the prescribed dosage; 8
(e) A teletherapy radiation dose when the calculated weekly administered 9 dose ti; it p::::;; ;;;.;;;r :hnlaxceada the weekly prescribed dose bv is nereent 10 gr more of the weakiv nreggibed done; or h /;
11 (f J
.A brachytherapy radiation dose when the calculated administered dose 12 dif fers f rom the prescribed dose by more than ten percent of the prescribed dose.
13 " Teletherapy" means therapeutic irradiation in which the source of 14 radiation is at a distance from the body, 15
" Teletherapy physicist" means the individual identified as the teletherapy 16 physicist on a license issued by the Executive Secretary.
/ pW h 17 " Visiting authorized user" means an authorized user who 19 not identified 18 as an authorized user on the license of the licensee being visited. /
19 g Written directive" means an order in writing for a specific patient J2I 80 human research subinet, dated and signed by an authorized user prior to the V 21 V administration of a radiopharmaceutical or radiation, except as specified (fee 22 h ;;hy;h ;;;y]In narmaranh (f) of this definition. containing the following 23 information: G (C N C.C /
24 (a) for any administration of quantities greater than 1.11 MBq (30 uci) 25 of either sodium iodide I-125 or I-131: the dosage; 26 (b) for a therapeutic administration of a radiopharmaceutical other than 27 sodium iodide I-125=or 1-131: the radiopharma:eutical, dosage, and route of 28 -administrat!.on; 6
1 (c) for gamma stereotactic radiosurgery: target coordinates, collimator 2 size, plug pattern, and total doses 3 (d) for teletherapy: the total dose, dose per fraction, treatment site, 4 and overall treatment period 5 (e) for high-dose-rate remote afterloading brachytherapy: the 6 radioisotope, tre.itment site, and total doses or 7 (f) for all other brachytherapy 8 (1) prior to implantation: the radionuclide, number of sources, and
! 9 source strengths; and 10 tii) after implantation but prior to completion of the procedures the l
) 11 radionuclide, treatment site, and total source strength and exposure time, g l 18 e uivalently, the total dose.
13 3 O f(clI'IttC L 14 1313 32-6. Provinia== for mammarch involvine Ma=*a subineta 15 A lienname mav conduct rammarch involvinn human subinets usina enA4amaelvaf 16 ==E=$4 m r nrovidad that the research is conducted funded, munnerted. or ranulated 17 by annthen_ Faderal Aaenev which han imniemanted the Federal Poliev for the 18 Protection of Humar.fubiects. Otherwise. a licensee shall anniv for and receive l r
19 menroval of a anecific amendment to its Utah license before conductino much 20 _raamarch. Both tvnea of licenseen shall. at a minimum, obtain informed consent) 21 from the human subiecta and obtain nrior review and annroval of the research 22 activities by an *fna_titutigggi Review Board
- in mecordance with the meanina of 23 thane tenna an defined and doacribed in the Federal Poliev for the Protection of 24 Human subineta.
25 26 m313-32 7. Pna..,gther Fadaval, armi stata manuir- ata .
27 Nothina in R313-31 relieven the licenmee from comnivina with annlicable 28 FDA. ether Federal. and State requirementa covernino radioactive druon or 7
A e
1 .davican. ~
2
( 4 _
C
- 3. R313 32 11. License Required.
4 (1) A person shall not wanufacture, produce, acquire, receive, possess, 5 use, or transfer radzoactive material for medical use except in accordance with l 6 a specific license issued by the Executive Secretary, the Nuclear Regulatory 7 commission, or an Agreement state, or as allowed in R313 32 11(2) er (3) ,
8 (2) An individual shall receive, possess, use,-or transfer radioactive 9
material in accordance with the Utah Radiation Control Rules under the 10 supervision of an authorized user as provided in R313-32-25, unless prohibited 11 by license condition.
12 (3) An individuni mav nrana re unmaal ed +=dia-ativa~ ==6-4=1" for medlemi 13 uma in accordanen with R313 32 under the munervimiu of an authorized nucinar 14 charmacist er authorized usar,as nrovidad in R313-32-25. uniera orchibited by 15 lleanna condition.
1s 17 R313-32-12. A==11eation for Lie ====. * '---t. or a==-wai Icatgwgb 18 fit if the annifemeten in for mad 4eal uma sited in a medical institution.
19 oniv the institution e s manaammant may anniv.
if the annlication in for medical 20 uma not mitad in a medicai institution. any normen may anniv.
21 (2) An annlication for a lican=a for medical uma of radia--dva ==6--a="
22 an dameribed in R313-32-100. R113-32-200. R313-32-300. R313-32-400, and R313 23 500 must be made by filina of Pom DRc-02. 'Annlication for Materimin Licanne.a 24 For auidanea in enmniatina the form. rafar to the instructinna in the most 25 current verminn= of the annrenriate Recruimterv auiden . A reauant for a licenna 86 amandm-nt or ranawai mav-be mubmitted in a letter format. -
27 (3) An annlicant ehnt natinflam tha reauiram-nta anecified in R313 22-50f2) 28 mav anniv for a tvna A moneific licanna of broad neone.
8
'cate D 1 R313 33 13. License Amendment. d Cyg -
2 A licensee shall apply for and receive a license amendment:
3 (1) before it receives or uses radioactive natorial for a clinical 4 procedure permitted under R313 32 but not permitted by the license issued 5 pursuant to R313-32; 6 (2) before it permits anyonet, :x ;p : vi;itir.; n n:rin d 2: d=:;i w 7 ir. n::,1 :2-44) to work as an authorized user or authorized nuclear charmacist l 8 under the license (t) excent an 4ndividual who ini 9 fa) an authorized user certified by the oroanizations specified in 10 paragranh fil of n113-12-910. n313-32-920. n113 9 3 0. niis - 3 2 - 94 0. niis-32-9so.
11 or usi3-32-9Eot 12 (b) an authorized nuclear nharmacist certified bv the oronniration 13 apacified in narmoraoh fil of n313-32-9s01-14 (c) identified as an authorized user or an authorized nuclear charmacist 15 ' on a Nuclear Raoulaterv Comminaion or an Aornament state licanne that authnrires 16 the une of radia-a*iva ==a*=-im1/ in medical une or in the oractice of nuclear 17 charmaev. rennectiveiv. or g h f(M od"/
18 (di identified an an authnrized user or an authorized nuclear nharmacist y /
19 on a normit immund by the #waantive a.neatarv2 the Nuclear necrulatory comminaion 20 or an Aoreement state anecific licaname of broad econe that is authorized to 21 p,tImit the une ef radinmetive saat ari al' in medical une or in the oractice of 22 nuclear charmaev. renometivelv.
23 (3) before it changes Radiation Safety Officers or Teletherapy Physicists:
24 (4) before it orders radioactive material in excess of the amount, or 25 radionuclide or form different than authorized on the licenses and 26 (5) before it adds to or changes the address or addresses of use 27 identified on the license.
28 9
Ca Sy D 1 R313-32 14.
, /
Notifications. ,,
2 (A li u:::: shall not4fy th; ::n;;uti c; 0;cr;tery by 1cteer wuhtn n day; 3 when r cetheetee6-eeer, nadiati;n ::fety of fie:r, er - ;;1ctwe,epy phy,4,4,g 4 perman:nt ly d+ecent4wuee-peefermance-of-dut4eemmdcr th; lieer;; or h:: name 5 chang;, er wh;n th; licen ;;'s .ciling-eddrc;; chang;;,) (1) A licensee shall 6 provide to the Executive Egeratarv!n cony of the board certification. the Nuclegg 7 Reculatorv Commission or Aareement state license, or the termit issued by a 0 licensee of broad scope for each individual no later than 30 days af ter the date 9 that the licensee nermits the individual to work as an authorized user or an 1
/
rauthorized nuclear bharmacist nursuant t o R 313 - 3 2- 12 (2 ) f a) throuch (2) (d) . t
\
/
1}7 (2)
Sho4( be W.in 3rts A liegngee shall notifv the Executive Secretarv8 v letter no V)%gl ()), /
tgr 12 than 30 davs afttri 13 .f a )
an authorized user. an authorized nuclear nharmacist. Radiation Eg{gty /
14 Officer. or teletherany chvsicist nermanentiv discontinues nerformance of duties 15 under the license or has a name changer or 16 (b) the licensee's mailina address chances.
17 (3) The licensee shall mail the documents recuired in R313-32-14 to the 18 address identified in 13-12 h I 19 QK,,-110.I J
cty M,fte ,
=
p'T 20 R313-32-15. Exemotions Recardina Tyne A Enseific Liggggas of Broad Seg m t (L 21 A.11ggnage nessessina a Tyne A specific license of broad scene for medical y 22 use is exemot from the followinar 23 (1) The nrovisions of R313-32-13(2)1 '
24 (2) The orovisions of R313-32-13(5) reaarding additions to or chanaes in 25 the areas of use oniv at the addresses snecified in the licenser 26 f3) The orovisions of R313 32-14 (1) r and 27 (4) The crovisions of R313 - 3 2 -14 (2 ) f a) for an authorized user or an 28 authorized nuclear charmacist.
10
9cy'V -
c J 4 1 u n-n.1.. u...se u.uanee.
2- The Executive secretary shall issue a license for the medical use of 3 radioactive material for a *erm of five years provided the following requirements !
-4 are mets .
5 (1) The applicant has flied form DRC-02 " Application for Materiale License 6 Medical" in accordance with the instructions in R313-22-32.
7 (2) The applicant has paid any applicable fee as provided in R313-70, 1
8 (3) The Executive Secretary finds the applicant equipped and committed to 9 observe the safety standards established in R313-15 for the protection of the 10 public health and safety.
11 (4) In addition to the requirements set forth in R313-22 33 a specific 12 license for human use of radioactive material in institutions will be issued it:
13 (a) the applicant has appointed a radiation safety committee to coordinate 14 the use of radioactive material throughout that institution and to maintain 15 surveillance over the institution's radiation satety program; and
'16 (b) if the application is for a license to ute unspecified quantities or 17 multiple types of radioactive material, the applicant's staff has training and 18 experience in the use of a variety or radioactive materials for a variety of 19 human uses, and meets the training and. experience requirements of R313-32.
20 (5) A specific license for the human use of radioactive material will be 21 issued to an individual physician if the following are complied with:
22 (a) The applicant has access to a hospital possessing adtquate facilities 23 to hospitalize and monitor the applicant's radioactive patients whenever it is 24 advisable.
25 (b) The applicant has training and experience as required by 0313-32, in 26 the handling and administration of radioactive material and, where applicable, 87 the clinical management of radioactive patients.
28 (c) The application is for use in the applicant's practice in an office 11
. . _ . - - . . . . . . _ _ _ . - - . - . _ ~. .. - . . - _ _ . - . . - . _
1 -outside a medical institution.
l 2 (d) The Executive Secretary shall not approve an application by an 3 individual physician or group of physicians for a specific license to receive, 4 possess or use radioactive material on the premises of a medical institution ;
5 unless:
6 (i) the use of radioactive material is limited to 7 (A) the administration of radiopharmaceuticals for diagnostic or 8 therapeutic purposes; 9' (B) the performance of diagnostic studies on patients to whom a 10 radiopharmaceutical has been administered; 2,1 (c) the performance of in vitro diagnostic studies; 12 (D) the calibration and quality control checks of radioactive assay 13 instrumentation, radiation safety instrumentation and diagnostic instrumentations 14 (ii) the physician brings the radioactive material with him and removes 15 the radioactive material when he departs. The institution cannot receive, 16 possess or store radioactive material other than the amount of material remaining l' in the patients or 18 (iii) the medical institution does not hold a radioactive material license 19 issued pursuant to the provisions of R313-32-18 (4) .
2o gje )
21 R313-33-19. Specific Exemptions. I 22 The Board may, upon application of any interested person or upon its own 23 initiative, grant exemptions from the rules in R313-32 as it determines are 24 authorized by law and will not endanger life or property or the common defense 25 and security and are otherwise in the public interest. The Board will review 26 requests for exemptions from training and experience requirements with the
~
27 assistance of the Executive Secretary.
28 12
' l
, y -
1 R313-32 20. ArARA Program. 4 --
u (A
U Q 40k "
d 2 (1) The licensee shall develop and implement a written radiation l 3 protection program that includes provisions for keeping doses A1 ARA.
4 (2) To satisfy the requirement of R313-32 20(1) one of the following shall 5 be implemented:
6 (a) At a medical institution, management, the Radiation Safety Officer, 7 and authorized users shall participate in the program as requested by the 1
8 Radiation safety committee.
i 9 (b) For licensees that are not medical institutions, management and 10 authorized users shall participate in the program as requested by the Radiation !
11 safety officer.
12 (3) The program shall include notice to workers of the program's existence 13 and workers' responsibility to help keep dose equivalents ALARA, a review of 14 summaries of the types and amounts of radioactive material used, occupational 15 doses, changes in radiation safety procedures and safety measures, and continuing 16 education and training for personnel who work with or in the vicinity of 17 radioactive material. The purpose of the review is to ensure that licensees make 18 a reasonable ef f ort to maintain individual and collective occupational doses 1 19 AIARA. '
30 hT/0 I
')
21 R313 32-21. Radiation Safety Officer. b +
22 (1) AlicenseeshallappointaRadiationsafetyOfficerresponsiblefor) l
- 23. implementing the radiation safety program. The licensee, through the Radiation 84 safety officer, shall ensure that radiation safety activities are being performed h 25 -in accordance with approved procedures and regulatory requirements in the daily 26 operation of the licensee's radioactive material program.
27 (2) The Radiation safety Officer shall:
28 (a) investigate overexposures, accidents, spills, losses, thefts, 13
1 unauthorized receipts, uses, transfers, disposals, misadministrations, and other 2 deviations from approved radiation safety practices and implement corrective 3 actions as necessarys 4
(b) establish, collect in one binder or file, and implement written policy 5 and procedures for 6 (i) authorizing the purchase of radioactive material 7 (ii) receiving and opening packages of radioactive materials 8 (iii) storing radioactive material 9 (iv) keeping an inventory record of radioactive materiali 10 (v) using radioactive material safely; 11 (vi) taking emergency action it control of radioactive material is losts 12 (vii) performing periodic radiation surveys 13 (viii) performing checks of survey instruments and other safety equipment; 14 (ix) disposing of radioactive materiali 15 (x) training personnel who work in or f requent areas where radioactive 16 material is used or stored 17 (xi) keeping a copy of all records and reports required by the Utah 88 Radiation Control Rules, a copy of these rules, a copy of each licensing request, 19 license and amendment, and written policy and procedures required by the rules; 20 (c) brief management once a year on the radioactive material program; 21 (d) establish personnel exposure investigational levels that, when 88 exceeded, will initiate an investigation by the Radiation Safety Officer of the 23 cause of the exposures 24 (e) establish personnel exposure investigational levels that, when 35 exceeded, will initiate a prompt investigation by the Radiation Safety Officer 26 of the cause of the exposure and a consideration of actions that might be taken 27 to reduce the probability of recurrences 28 (f) for medical use not at a medical institution, approve or disapprove 14
1 radiation safety program char,ges with the advice and consent of managements and 2 (g) for medical use at a medical institution, assist the Radiation Safety 3 Committee in the performance of its duties. ,
4 , fg/Mt 0 2 Ok 5 m:13 32 22. mediation safety Committee. g 6 The medical institution licensee shall establish a Radiation Safety 7 Committee to oversee the use of radioactive material.
8 (1) The Committee shall meet the following administrative requirements:
9 (a) Membership shall consist of at least three individuals and shall 10 include an authorized user of each type of use permitted by the license, the 11 Radiation Safety officer, a representative of the nursing service, and a 12 representative of management who is neither an authorized user nor a Radiation 13 Safety officer, other members may be included as the licensee deems appropriate.
14 (b) The Committee shall meet at least quarterly.
15 (c) To establish a quorum and to conduct business, at least one-half of 16 the Committee's membership shall be present, including the Radiation Safety 17 officer and the management's representative.
18 (d) The minutes of each Radiation Safety Committee meeting shall include:
19 (1) the date of the meeting; 20 (ii) members presenti 21 (iii) members absent; 22 (iv) summary of deliberations and discussions; 23 (v) recommended actions and the numerical results of all ballots; and 24 (vi) ALARA program reviews described in R313-32-20.
25 (e) The Committee shall promptly provide the members with copies of the 26 meeting minutes, and retain one copy for the duration of the license.
27 (2) To oversee the use of licensed material, the Committee shall:
28 (a) review recommendations on ways to maintain individual and collective 15
1 doses ALARA 2
(b).dl review, on the basis of safety and with regard to the training and 3
experience standards in R313 32 900 through R313 32-(MG)1tl, and approve or 4
disapprove any individual who is to be listed as an authorized user, an [
5 Authorized nuclear charmacist. the Radiation Safety Officer, or a Teletherapy.)
6 Physicist before submitting a license application or request for amendment or 7 renewal or 8
(11) review. oursuant to R113 13 (2) (a) throuch (2) (d) . on the bania of 9 the board ggrtification. the licenne. or tha nermit identifvino an individual.
10 and anorove or dinarnrove any individual nrior to allowine that individual to i 11 work an an authorized user or authorized nuclear charmacintr_
12 (c) review on the basis of safety, and approve with the advice and consent 13 of the Radiation Safety Of ficer and the management representative, or disapprove 14 minor changes in radiation safety procedures that are not potentially important 15 to safety and are permitted under R313 32 311 16 (d) review quarterly, with the assistance of the Radiation Safety Officer, 17 a summary of the occupational radiation dose records of personnel working with 18 radioactive materials 19 (e) review quarterly, with the assistance of the Radiation Safety Officer, 20 incidents involving radioactive material with respect to cause and subsequent 21 actions taken; and 32 (f) review annually, with the assistance of the Radiation Safety Officer, 23 the radiation safety program.
34 1
$0(
25 R313-32-23. Statements of Authority and Responsibilities. k 26- (1) A licensee shall provide the Radiation Safety Of ficer, and at a 27 medical institution the Radiation Safety Committee, sufficient authority, a
l'+S 28 organizational freedom, and management prerogative, to:
16
~
o
1 (a) identify radiation safety problemas 2 (b) initiate, recommend, or provide corrective actions; and ;
3 (c) verify implementation of corrective actions.
4 (2) A licensee shall establish and state in writing the authorities, 5 duties, responsibilities, and radiation safety activities of the Radiation Safety 6 officer, and at a medical institution the Radiation Safety Comnittee, and retain 7 the enrrent edition of these statements as a record until the Executive secretary 8 terminates the license.
, , WM $
)
10 m313 32-25. supervisiou. I gg g /
11 (1) A licensee that permits the receipt, possession, use or transfer of 12 radioactive material by an individual under the supervision of an authorized user 13 as allowed by R333-32-11(2) shall:
14 (a) instruct the sapervised individual in the principles of radiation 15 safety appropriate to that individual's use of radioactive material and in the 16 = licensee's written quality management program; 17 (b) _ require the supervised individual to follow the instructions of the
- 18. supervising authorized user, follow the written radiation safety and quality 19 management procedures established by the licensee, and comply with the Utah 20 Radiation Control Rules and the license conditions with respect to the use of 21 radioactive materials and 22 (c) periodically review the supervised individual's use of radioactive 123 material and the records kept to reflect this use.
24 (2) A licensee that eer1 nit e the oreparation of( " f# " h " nam *m-4y8for 25 medical une bv an individual under the munervision of an authorized nuclear [
26 nharmacist or ehvsician whn in an authorized user. an allowed by R313-32-11f3).
-27 ahalli
'28' fa) (natruct the aunervised individuni in the orenaration of +mdema*tive'f 17
e -e 1
(- ~ ^rM.nAhnIfor madical uma and the nrinelnlaa of and nrocedures for radiation
- 3. anfatv and in the licanmaa8 a writtan crum11tv manaammant nrocrram. an annronriata 3 to that individualda uma of W E M Aa =an M Nl 4 lb) rammi ra the aunarvised individum1 to follow the instructinna aivan 5 sura" ant to msis-22-2s (2) In) and to c==iv with thema ruien and iiennaa 6 canditiannt and 7'-
fe) recruire the aunarviains authnrized nurinar charmacist or ehvmician who -
l
- 8. in an authorized usar to nariodically review the work of the aunarvised <
l l 9 individuni as it nartalna to nranariner " " "--.d um ,saamme.. amu for medical uma and
.._n -
10 the recorda kant to refinet that work.
l 11 ( [ ell) A licensee that supervises an individual is responsible for the 13 acts and omissions of the superviced individual.
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g- C p ,g b 9 R313 32 29. Administrative Requirements that Apply to the Providers of Mobile 10 wuclear Medicine service.
11 (1) The Executive Secretary will license mobile nuclear medicine service J 13 only in accordance with R313 32-100, R313-32-200, and R313 32-500.
13 (2) Mobile nuclear medicine service licensees shall obtain a letter signed 14 by the management of each client for which services are rendered that authorizes 15 use of radioactive material at the client's address of use. The mobile nuclear 16 medicine service licensee shall retain the letter for three years after the last 17 provision of service.
18 (3) If a mobile nuclear medicine service provides services that the client 19 is also authorized to provide, the client is responsible for assuring that 20 services are conducted in accordance with the rules while the mobile nuclear 21 medicine service is under the client's direction.
32 (4) A mobile nuclear medicine service shall not order radioactive material 23 to be delivered directly from the manufacturer or distributor to the client's 24 address of use.
9 25 I 26 R313-32-31. Radiation Safety Program Changes. ,
' Cnyqr)j #-
27 (1) A licensee may make minor changes in radiation safety procedure's that 28 are not potentially important to safety, 1--e., ministerial changes, that were 19
1 described in the application for license, renewal, or amendment except for those 2 changes in R313 32-13 and R313 32-606. A licensee is responsible for assuring 3 that any change made is in compliance with the requirements of the rules and the 4 license.
5 (2) A licensee shall retain a record of each change until the license has 6
been renewed or terminated. The record shall include the effective date of the 7 change, a copy of the old and new radiation safety procedures, the reason for the 8
change, a summary of radiation safety matters that were considered before making 9
the change, the signature of the Radiation Safety Officer, and the signatures of 80 the affected authorized users and of management or, in a medical institution, the 11 Radiation Safety Committee's chairman and the management representative.
D
}0f[j 13 R313 32 32. Quality Management Program. ( '_ U 14 p$ (1) The applicant or liceo .ee shall establish and maintain a writt 15 quality management program to provide high confidence that radioactive material 16 or radiation from radioactive material will be administered as directed by the 17 authorized user. The quality management program shall include written policies 18 and procedures to meet the following specific objectives:
O (a) that, prior to administration, a written directive is prepared for:
20 (1) teletherapy radiation doses; 21 (ii) gamma stereotactic radiosurgery radiation doses:
82 (iii) brachytherapy radiation doses; 23 (iv) administration of quantities greater than 1.11 MBq (30 uCi) of either 24 sodiut. iodide I-125 or I-1311 25 (v) therapeutic aaministration of a radiopharmaceutical, other than sodium 26 iodide I-125 or I-131; 37 (b) thr', the following are exceptions to the written directives 28 (i) it, because of the patient's condition, a delay in order ce provide 20
. 1 1 a written revision to an existing written directive would jeopardize the
-2 patient's health, an oral revision to an existing written directive will be r
3 acceptable, provided that the oral revision is documented immediately in the 4 patient's record and a revised written directive is signed by the authorized user 5 within 4e hours of the oral revisions 6 (ii) also, a written revision to an existing written directive may be made 7 for a diagnostic or therapeutic procedure provided that the revision is dated and 8 signed by an authorised user prior to the administration' of the .
9 radiopharmaceutical dosage, the brachytherapy dose, _ the gamma stereotactic 10 radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose t
11 or 12 (iii) -if, because of the emergent nature of the patient's condition, a 13 delay in order to provide a written -directive would jeopardine the patient's 14 health, an oral directive will be acceptable, provided that the information 15 contained in the oral directive is documented imediately in the patient's record i
16 and a written directive is preparec within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directives 17 -(c) that, prior to sach administration, the patient's or hn=mn rammarch 18 mubiect's identity is verified by more than one method as the individual named 19 in the written directivei 20 (d) that final plans of treatment and related calculations for M- brachytherapy, taletherapy, and gamma stereotactic radiosurgery are in accordance 22 with the respective written directives; 23 (e) that each administration is in accordance with the written directives 24 and 25 (f) that each unintended deviation from the written directive is 26 identified and evaluated, and appropriate action is taken.
27 (2) The licensee shall: J [ $
- 2 8. (a) develop procedures for and conduct a review of the quality management 21 l
1 -program including, since the last .eview, an evaluation of:
2 .( i) L. representative sample [e) of patient and h"--a rammarch muh4 met 3' - administrations 4 (ii) all recordable events, and 5 '(111) all_misadministrations to verify cogliance with each aspect of the 6 quality management programs these reviews shall be conducted at intervals no 7 greater than 12 months; 8
(b) evaluate these reviews to determino the effectiveness of the quality 9
management program and, it required, make modifications to meet the objectives 10 of R313-32-32 (1); and 18 (c) retain records of the review, including the evaluations and findings 12 of the review,'in an auditable form for_three years.
( 13 (3) The licensee shall evaluate and respond, within 30 days after I
i 14 discovery of the recordable event, to each recordable event by:
15 (a) assembling the relevant facts including the causes 16 (b) identifying what, if applicable, corrective action is required to 17 prevent recurrences and 18 (c) retaining a record, in an auditable form, for three years, of the 19- relevant facts and what corrective action, if applicable, was taken.
20- (4) The licensee shall retaini 21- (a) a written directives and 22 (b) a record of each administered radiation dose or radiopharmaceutical 23 dosage where a written directive is required in R313-32-32(1) (a), in an auditable 24 form, for three years after the date of administration.
-25 (5) _ The_ licensee may make modifications to the quality management program 26 'to increase the program's efficiency provided the program's effectiveness is not
-27 decreened. The . licensee shall fumish the modification to the Executive 28;
-Secretary within 30 days after the modification has been made.
22
4 1 (6)ta) Applicants for a new iteense, as applicable, shall submit to the 8 Executive Secretary in accordance with R313 12 110 a quality management program 3 as part of the application for a license and implement the program upon issuance 4 of the license by the Executive secretary.
5 (b) Existing licensees, as applicable, shall submit to the Executive 6 secretary in accordance with R313-12-110, prior to March 1, 1995, a written 7 certification that the quality management program has been implemented along with 8 a copy of the program. f {~
'10 9
R313 33 33.
b w
- fg[cd 7ph &
MotificationsTaeports and Records of Misadministrations.
f T h' og (
11 (1) ( h n)Isr a misadministration.t! ;;= :, )
12 fal _the licensee shall notify the raneoutive;: Sees 1etarf by telephone no
[
13 later than the next calendar day after discovery of the misadministration.
14 (b) the licensen shall anhmit a written renort to the " # '- [$ '$$
s 15 within 15 days after discovery of the misadministration. The written recort 16 include the licaname'a namer the cremeribina ehvaielan'a namer a brief 11 a_, demerintion of the event, why the event occurred, the effect on the individual 18 who received the miandministration, what imorevementa are needed to erevent 19 recurrencer actions taken to orevent recurrencer whether the licensee notified 20 the individual for the individunid a rescensible relative or cuardian). and if i 21 not. why not; and if there was notification. what information was erovided. The 22 reoort must not include the individua18 a name or any other information that couM 23 lead to identification of the individual. To meet tha recuirements of R313 24 33. the notification of the individual receivino the misadministration may be l 25 made instead to that individua1's resconsible relative or auardian. when 26 annronriate.
27 .LcL, [T)the licensee shall [elee-) notify the referring physician and also 28 notify the individual receivino the misadministration of the misadministration 23 l
e a p
l 1
no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discoverv. _unless the referring physician l
8 persona 11v informs the licenmee either that he will inform the individual or 3
1.hatt;ir;:: 0; i ' m th: p:ti:nt ;r b:11;c; ). based on medical judgment, (thet 4 ltelling the i ndi vidua l (7..' ' .- .' . - . ' . ' . . . . -
7 . - ...' - . . . ' . - . . . , .7 - . . . .. ' ' , ' . . . . - ' . . . . . -
m'-.
5 3;;rdian!) would be harmful.(- t; :: ee--- t h: ;ther, sc-:p;;t i r:17 "'h;;;
6 net >.>.1. >._- _ w.. . . s ,.
e., .- . _ -_ 2.
.>a...i... s, u_...- .
- a. . .. <$.... .s. i. .-..... . _ -
. .. . a. . .
7 i;;',ini;t ;ti;n,) The lieansee is not recuired to notify the individual 8 without first consultine the referrina ehvaician. If the referring physician [r 9 p;ti:.t, ;; th: p;ti:nt'; ::p ;;ihl: :1;.t i c; ;r 5;;.rdien) or the individual 80 z.e.ceivino the minadministration 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 l
11 shall notify the(m) individual as soon as (penet4eeMej oomnible thereaf ter. The 18 licensee (4; n;t
- pir:d t; n:ti'y th: p .ti;n'. ;; th; p:.ti .nt '; -:::p;n:ihl:
13 eetet4. . - _ . . .s. .> .
._.>a.....,..
. .2 .... .. . ... .s u. .,_
. . a. . . ...._>_c.,.>. .-_ u-. . . . -
...w r- ----- , -- - ,
14 th: '.i::n::: :h:11]may not delay = any meorentiate medical care for the 15 (pati:ntlindividual. includino any necearary remedial care an a result of the 16 misadministration. because of (th+elanv delav in notification, 17
((G]d) if the individuai van notified. cha licensee shall also furnish.
18 (W)within 15 days after discovery of the misadministration, (th; lic;n;;; :h.11 19 eem64--J a written - report (r) to the (seeentic; 0::::t;;y :.nd t; th: ::' rrin-80 ph.,... .>. ..>. .. , _,
......__2..u.. . . . .
. . 7 ,. , , . a. . . ..r. ... .. ..
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81 :::p;;;ib1: ::1 tic; ;r g;;.rdi:.n i' cith: ::: :tifi:d by th; li::n:::. -h; 22 ._. . s. u. u..- . . , , . .. ..u_.,s.
2,..>.
....._ . a. . . . i.s..-....-..
. . .. _ - . . . . , . a.. - r-------a -- sus-- u...a.s._,.
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23 __
.. ~ ,., .-. .u..>.a. s. ,. . .-
. s.ra ---
a . _ --- . a.
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- a. .am... -- a.
24 -_&a__m r-----,
__m 2_-_
t L__ &_-__._m r-- - - --_. ---- -- __-__
--,. -1&L_- &L. ,a___-__ 2 m _ __ _ s mL.
85 ...
r-----
2.-. -- a. - .i. ... ------.aus. - s . 2 . .. -- _-.- s2.. .> sa
-- -- r---- - - --
r- ----- ---- --- -- a-----. -- -- -.---,.x..- i . . . .
86 .-..,s. 1e
.. . s. L. ~-
--ul--L r-----
.-.w 1ga >
.L-w 12. --uA-- __ --.1s A L_ wL. --ul--u
r------- -- -- r---- --
-27 m...._ _____m.
r.. _ t. _ s. s.
. __m.
2__s.2_
__m
.t..-_ r---- 2 _m ,_ ____ __ _
t__ 2_,____m2__ u_m __.32 28 49 d t; id:nti'i :ti;n O' th; patient.) individual bv sendino eithert 24
_ _ _ . . _ . _ _ _ . _ _ . .m _ - _ . . - - . _ . . - _ _ _ _ - .__ - ~ . _ _ _ _ _ _ _ . - _ _ . _._ _
1 fil a conv of the rannrt tha t wam_ gphei t ted to t ha # " d C- - --M a'=v", or 2 MMriar d==crintinn of both th avant and th ennmanuances na thav mav 3 af f ect the individual. nrovidad a statament is includad that the renort anhmitted 4 to the can be obtained from the licanmaa.
5 ( [4)2) The licensee shall retain a record of each misadministration for 6 five years. The record shall contain the names of all individuals involved [+n 7 th: ..:n ) (including the prescribing physician, allied health personnel, the 8 l @ ) individual whn recalved the miandministration, and thle)at /
9 (p;timtlindividual's referring phyaician. if ane11embia), the t/
10 (p;ti stlindividual's social security number or other identification number if /
I 11 one has been assigned, a brief description of the misadministration, why it 12 occurred, the ef fect on the (pet 4+ne} individual, [and-wiet -) t tnprovements lace -) /
13 needed to prevent recurrence (t) J the actions taken to prevent recurrence. /
14 ([412) Aside from the notification requirement, nothing in R313-32 3[#)2 15 affects any rights or duties of licensees and physicians in relation to each 16 other, [p;ti:nte]to individuals reenivina miandministratinna, or to that 17 individua1*a responsible relative (e) (4)or guardian (e/4. --
18 --
,h se' p
' r^n 19 R313 32 49. Suppliers _for samlad sauream or Davie=a f or Medical t'ma. ,
20 A licensee may use for medical use onlyi (d a b 21 (1) (n di= :tiv: =t ui:1] sam 1=d mources or deviema manufactured, labeled, y 22 packaged, and distributed in accordance with a license issued pursuant to the 23 - rules in R313-22[-44) and R313-22-75(10) (tFr:xp nn: 00 M ':0) -l or the 24 equivalent (n gul;.ti :)rmouiramants of the Nucluar Regulatory Commission or an v 25 Agreement state (r)2._or(
26 ':) ":: gut hit; th:t h;:: i:r =;;f :tund, 1 b 1:d, p -ke;;d, =d 27 di:tcibut;d in ::: n d:::: uith :n :p; n c.1 by :h: nn : tic; On:::::f pr::=t 28 :: n::: :: 30, n :q::v .lut ::g 1 ti=: :f th: " :1::: n:g;1 t ry c ....i;;im se 25
e I
1 1 :n?q:n x :::. : f: th: p::p::::ica :: ::di:pa.=2::::1::.1 ::: n di;:1 :::)
2 (14)2) Teletherapy sources manufactured and distributed in accordance with 3 a license issued pursuant to R313 22 [-M) or the equivalent i
4
(;;g 12 i:::)rmouiramants of the Nuclear Regulatory Commission or an Agreement / !
5 state. / -
6 7 R313-32 50.
DY kJ ?WA Possession, Use, Calibration, and Check of Dose Calibrators.
Gyg l
))
8 (1) A ( :di::1 ::: ]1icensee ( ::h::i::d t: :dmini::::
9 ::di:ph: n;;=:i: 1 1shall (h:.._ in it: 1 possess [hn) and uma a dose calibrator /
10 (2nd ::: it-)to measure the ( :: -.: : ] activity of domma m of choton-emig g /
11 radionuclidas orier to administrat led] inn to each patient er human research y 12 subiect.
13 (2) A licensee shall:
14 (a) check each dose calibrator for constancy with-a dedicated check source 15 at the beginning of each day of use. To satisfy this requirement, the check 16 shall be done on a frequently used setting with a ses - source of not less than 17 370 kBq (ten uCi) of radium-226 or 1.85 MBq (50 uC1) for a photon-emitting '
18 radionuclides 19 (b) test each dose calibrator for accuracy upon installation and at least 20 annually thereafter by assaying at least two sealed sources containing different 21 k H u nuclides whose activity the manufacturer has determined within five percent 22 of ics stated activity, whose activity is at least 370 kBq (ten uC1) for radium-23 226 and 1.85 MBq (50 uci) for a photon-emitting radionuclide, and at least one 24 of which has a principal photon energy between 100 kev and 500 'teVs 25 (c) test each dose calibrator for 31nearity upon installation and at least 26 quarterly thereaf ter over (thla range (0 it: ::: 5::;n:] f rom the highest (/
27 dosage that will be administered to a patient or human raamarch subject _( nd M O V 28 - % )to 1.1 MP1 ([M)}g uCi); and 26
1 (d) test each r*>ce calibrator for geometry dependence upon installation 2 over the range of volvres and volume configurations for which it will be used.
3 The licensee shall keep a record of this test for the duration of the use of the 4 dose calibrator.
5 (3) A licensee shall also perform appropriate cheeks and tests regairer 6 by R313-32-50 following adjustment or repair of the dose calibrator.
7 (4) A licensee shall rnathematically correct dosage readings for geometry 8 or linearity errors that exceed ten percent if the dosage is greater than 370 kbq 9 (ten uci) and shall repair or replace the dose calibrator if the accuracy or 10 constancy error exceeds ten percent.
11 (5) A licensee shall retain a record of each check and test required by 82 R313-32-50 for three years unless directed otherwise. The records required in 13 R313 50 (2 ) (a) through (2) (d) shall include:
14 (a) for R313-32-50 (2 ) (a) , the model and serial number of the dose 15 calibrator, the identity of the radionuclide contained in the check source, the 16 date of the check, the activity measured, and the initials of the individual who 17 performed the check; 18 (b) for R313 50 (2 ) (b) , the model and serial number of the dose 19 calibrator, the model and serial number of each source used. (and-)the identity 20 of the radionuclide contained in the source and its activity, the date of the 31 test, the results of the test, and the (signatur: cf th; n: diction 0:fety 22 Officcelidentity of the individual eerformina the test; 23 (c) for R313 5 0 (2 ) (c) , the model and serial number of the dose 24 calibrator, the calculated activities, the measured activities, the date of the 35 test, and the (signatur: nf th; nadicti;n 0:fety Offic:r) identity of the /
36 individual performino the test; and 27 (d) for R313- 3 2- 50 (2) (d) , the model and serial number of the dose 28 calibrator, the configuration of the source measured, the activity measured for 27
l 1 each volume measured, the date of the test, and the (:ig.:t= ; cf th n:disti;n 2 0;f:ty O!!i;;;)idantitv of th= inellvidual nerformina the tg.
4 R313 32-51. v Calibration and check of survey Instruments.
C/yo [b up 5 (1) A licensee shall calibrate the survey inst
- uments used to show 6
compliance with R313-32 before first use, annually, and following repair. The 7 licensee shall: I 8
(a) calibrate all scales with readings up to ten mSv (1000 mrem) per hour 9 with a radiation source 10- (b) calibrate two separated readings on each scale that shall be 11 calibrated. The readings shall be separated by 50 percent of the scale readings 12 and 13 (c) conspicuously note on the instrument the apparent exposure rate from 14 a dedicated check source as determined at the time of calibration, and the date 15 of calibration.
16 (2) When calibrating a survey instrument, the licenses shall consider a 17 point as calibrated if the indicated exposure rate differs from the calculated 18 exposure- rate by not more than 20 percent, and shall conspicuously attach a 19 correction chart or graph to the instrument.
20 (3) A licensee shall check each survey instrument for proper operation 81 with the dedicated check source each day of use. A lict - e is not required to 22 keep records of these checks.
23 (4) A licensee shall retain a record of each survey instrument calibration 24 for three years. The record shall include:
25 (a) a description of the calibration procedure; and 26 (b) the date of the calibration, a description of the source used and the 27 certified exposure rates from the source, and the rates indicated by the
- 28. instrument being calibrated, the correction factors deduced from the calibration 28
1 data, and the signature of the individual who performed the calibration.
3 1313-12-52.
Qk . CVA b o/'3 _
Danaamalan. tfaa . cm3fbratian, amA r*kack af Tna tr** man ta to Manaurg 4 Domaana er Almka- er Bata m=4 ttina andlanuelidan.
5 fi) R313-32-E2 does not anniv to unit domanea of alnha- or beta-amittina 6 radionue11das that are obtained f rom a manuf acturer or oranarer 11eansed nursuant
-7 to R313 22-7Ef9) or asuivalant resuf ramenta of the Nucinar Raoulatory cram 4maion 8 or an Aormement Eta h 9 (2) For other than unit dommaan obtafnad curauant to R313 32-E2fi). a 10 licannae shall commama and une instrumentation to mammure the radica givity of 11 alnha- or beta amittino radionuclidea. The licannae shall have trocedures for 12 uma of the instrumentation. The licennae shall measure..by direct mammarament 13 er bv combination of mammuramanta and emieul.tions. the amnunt of radiometivity 14 in dosaama of minha- or beta-amittina radionuclidan orier to administration to 15 each natient or hupn raamarch subinet. In addition. the licanmee shalli 16 fa) cerform tenta before initini use. neriodiemilv. and followino renair. [
2,7 on each instrument for accuracy. linearitv. and aeometrv denandance. am 18 annronriate for the uma of the instruments and make adiuatments when necessary 19 and 20 lb) check each instrument for constancy and eroner eneration at zhe al bacinnina of each dav of use.
23 m313-32-53. Measurement of (5:fi:;t:--_:::ti:;l ) Dos o y sa. % PM a f "a maalad -* ---* *=a y 24 quatarial for Medical time.
Q h 25 A licensee shall: V V 26 (1) mcasure the activity of each (r:digh=-.:.:::ti :1 ) dosage [thet 87 n;.tcia: =:: th:2 : ~' O hq 't:a u0i! lof a photon emitting radionuclide 28 (bedecelprier to medical uses 29
. - _ _ . . _ _ _ _ _ . ~ _ _ _ - _ _ . -_ - . . _ _ _ _ _ . . _ _ _ _
1 (2) measure. by direct measurement or bv combinatien of measurements and 2 calculations. the activity of each (redfepharmaceWieel-) dosage (wi+P : d:ested 3 activity :: : 0 '-nq :::r. uci; er 1 :e-ef : ph: ten)of an alpna- er beta-emitting 4 radionuclide (before] prior to medical use. excent for unit doaages obtained from 5 a manufacturer or orecarer lice.naed oursuant to R313-22-75t9) or ecuivalent 6
recuirements of the nuclear Reculatorv commissier. or an A2I.cfment state ( +
7 veeHy t hat th; d:::5: d::: r.:t ext :d 2?O '- q iter uC4+]; and 8 (3) retain a record of the measurements required by R313-32-53 for three 9 years. To satisfy this requirement, the record shall contain the following:
10 (a) generic name, trade name, or abbreviation of the radiopharmaceutical, 11 its lot nunber, and expiration dates and the radionuclide; 12 (b) patient's or human research subiect's name, and identification number 13 if one has been assigned; 14 (c) prescribed dosage and activity of the dosage at the time of 15 measurement, or a notation that the total activity is less than ( ?O h0q)1.1 MBo 16 ((een) M uCi)i 17 (d) date and time of the measurement; and 18 (e) initials of the individual who made the record.
19 f 20 R313-32-57, Authorisatior. for Calibration and Reference Sources. Cafe ab 21 Perbons authorized by R313-32-11 for medical use of radioactive material 23 may receive, possess, and use the following radioactive material for check, 23 calibration, and reference use 24 (1) sealed sources manuf actured and distributed by a person licensed 25 pursuant to R313-22-75 ( (H]M) or equivalent Nuclear Regulatory Commission or 26 Agreement State regulations and that do not exceed 555 MBq (15 mC1) each; 27 (2) radioactive material listed in R313-32-100 or R313-32-200 with a half-28 lif e not longer than 100 days in individual amounts not to exceed $55 MBq (15 30
( , 1 e . I i
1 mci);
2 (3) radioactive material listed in R313-32 100 or R333 32 200 with a half.
3 life longer than 100 days in individual amounts not to exceed 7.4 Msg (200 uti);
4 and 5 (4) technetium 9pm in individual amounts not to exceed 1.85 oaq (50 mei) . #
6 7 R313-33-55. Requirements for Possession of Sealed Sources and Braebytherapy _,,
. S r....
4 9 (ms),
9 (1) A licensee in possessich of sealed sources or brachytherapy sources 10- shall follow the radiation safety and handling instructions supplied by the 11 manuf acturer, and shall maintain the instructions for the duration of source use 12 in a legible form convenient to users.
13 (2) A licensee in possession of a sealed source shall 14 (a) test the pource for leakage before its first use unless the licensee ,
15 has a certificate from the supplier indicating that the source was tested within 16 61N months before transfer to the licensee; and 17 (b) - tent the source for leakage at intervala not to exceed six months or 18 at other intervals approved by the Executive Secretary, the Nuclear Regulacory 19 commissaon or an Agreement state and described in the label or brochure that 20 accompanies the source.
21 (3) To satisfy the leak test requirements of R313-32-59, the licensee 82 must 23' (a) take a wipe sample from the sealed source or from the surfaces of the 24 device in which the sealed source is mounted or stored on which radioactive t
25 contamination might be expected to accumulate or wash the source in a small 26- volsme of detergent solution and treat the entire volume as the samples 27 (b) take teletherapy and other device source test samples when the source
-28 is in the "off" position; and 31
1 11) measuro the sample so that the leakage ttst cee :'tect the presence 2 of 185 Sq (0.005 uCij of radioactive material on the sample, 3 (4) A licensee shall retain leakage test records for five years. The 4 records shall contain the model number, the serial number if assigned, of each 5 source tested, the identity of each source radionuclide and its estimated 6 activity, the measured activity of each test sample expressed in becquerels or 7 microcuries, a description c' the method used to measure each . rest sample, the 8 date of the test, and the 6.gnature of the Radiation Safety Officer.
- 9 (5) If the leakage test reveals the presence of 185 Bq (0.005 uci) or more 10 of removable contamination, the Itcensee shall:
j 12 (a) immediately withdraw the sealed source from use and store it in 12 accordance with the requirements in R313-15; and 13 (b) file a report within five days of the leakage test with the Executive 14 Secretary describing the equipment involved, the test results, and the action 15 taken.
16 (6) A licensee need not perform a leakage test on the following sources:
17 (a) sources containing only radioactive material with a half-life of less 18 than 30 dayss 19 (b) sources containing only radioactive material as a gass 20 (c) sources containing 3.7 MBq (100 uCi) or less of beta or gamma-emitting 21 material or 370 kBq (ten uci) or less of alpha-emitting materials 22 _(d) sources stored and not being used. The licensee shall, however, test 23 each source for leakage before use or transfer unitas it has been leakage tested 24 within six months before the date of use or transfers and 25 (e) seeds of iridium-192 encased in nylon ribbon.
- 26- (7) A licensee in possession of a sealed source or brachytherapy source 12 7 shall conduct a quarterly physical inventory of all sources in its possession.
"18 -The licensee shall retain inventory records for five years. The inventory 32
f < .
l l 1 records shall contain the model number of each source, and serial number if one 2 has been assigned, the identity of each source radionuclide and its nominal m
h dr a
activity, the location of each source, and the signature of the Rad.ation Safety
- ' 4 officer.
= 3 (a) A licensee in 5 naession of a sealed source or brachytherapy aource 6 shall measure the ambient dose rates quarterly in all areas where sources kre 7 stored. This does not apply to teletherapy sources in teletherapy units or 8 sealed sources in diagnostic devices.
9 (9) A licensee shall retah a record of each survey required in R313 10 59(8) for three years. The record shall include the date of the survey, a plan 11 of each area that was surveyed, the measured dose rate at several points in each 1 la area expressed in microsieverts or millirem per hour, the survey instrument used,
_' 13 and the signature of the Radiation Safety Officer, i *'
15 R313-32-60. Syringe Shields Atd Labels. 4d q[CAy p/
16 (1) A licensee shall keep syringes that con h oactive material to 17 be administered in a radiation shield.
18 (2) To identi;y ice ontents, a licensee shall conspicuously label each 19 syringe (r) or syringe radiction shield that contains a syringe with a 20 radiopharmaceutical. The label shall show the radiopharmaceutical name or its 21 abbreviation, toe clinical procedure to be performed. or the patient's er the 22 human research subiect's .aame.
23 (3) A licensee shall require each individual who prepares a 24 radiopharmaceutical kit to use a syringe radiation shield when preparing the kit 25 and shall require each individual to use a syringe radiation shield when 26 administering a radiopharmaceutical by injection unless the use of the shield is 27 contraindicated for that patient er hum?n research subiect. V 28 33
1 R313-32-61. Vial Shields and Labels.
- C rM 2
(1) A licensee shall require each individual pr -carinj or bandling a vial 3 that contains a radiopharmaceutical to keep the vial in ca vial radiation shield.
4 (2) To identify its contents, a licensee shall conspicuously label each 5 vial radiation shield that contains a vial of a radiopharmaceutical. Tha labe' 6 shall show the radiopharmaceutical name or its abbreviation.
f' afecjoQ^}b 8 R313-32-70. Surveys for Contamination and Aanbient Radiation Exposure RatY.
~
9 (1) A licensee shall survey with a radiation detection survey instrument 10 at the end of each day of use all areas where radiopharmaceuticals are routinely 11 prepared for use or administered.
12 (2) A licensee shall survey with a radiation detection survey instrument 13 at least once each teek all areas where radiopharmaceuticals or 14 4.J:opharmaceutical waste is stored.
15 (3) A licensee shall conduct the surveys required by R313-32-70(1) and (2) 16 so as to be able to detect dose rates as low as one usv (0.1 mrem) per hour.
17 (4) A licensee shall establish radiation dose rate trigger levele for the g 18 surveys required by R313-32-70(1) and (2). A licensee shall require that the l 19 individual performing the survey immediately notify the Radiation Safety Officer 1
20 if a dose rate exceeds a trigger level.
21 (5) A licensee shall survey for removable contamination once each week all /
22 areas where radiopharmaceuticals are routinely prepared for use, administered, 23 or stored.
24 (6) A licensee shall conduct the survey required by R313-32-70(5) so as 25 to be able to detect contamination on each wipe sample of 2200 disintegrations # \
-~- /
26 per minute, (0.001 uci or 37 sq).
27 ML W 000 (7) A licensee shall establish removable contamination trigger levels for 28 the surveys required by R313-32-70 (5) . A licensee shall require that the 34
C ' O 1 individual pcrforming the survey immediately notify ti.t Radiation Safety Officer /
2 if contamination exceeds the trigger level.
3 (8)- A licensee shall retain a record of each survaty for three years. The 4 record shall include the date of the survey, a plan of each area surveyed, the 5 trigger level established for each area, the detected dose rate at several points 6 in each area expressed in microsieverts or millirem per hour or the removable 7 contamination in each area expressed in disintegrations per minute (becquerels 8 or curies) per 100 square centimeters the instrumene used to make the survey or 9 analyze the samples, and the initials of the individual who performed the survey.
- 1 11 R313-32-75. Release of (PeMonte]Individuala Containing Radiopharmaceuticals or f ca% C 69 ,
1 12 Permanent Implants. 0.f6 G0
-/ V ( J 13 (1) [A]Ihn 1.4censee (:h li act)may authorize tha release from ( :..!in ::n 14 fr c:di :1 :::: ; p Meet]its control of ar v 4ndividual who han been
( 15 administered (e--) radiopharmaceuticals or permanent imolante containino i _
16 radioactive material if the total effective done ecuivalent to any other
{'
17 individual from ernomure to the released individual is not likely to exceed 5 mSv l~
18 (0.5 rem).[ until cither; 19 ;;; th :::ur:0 d::; ::: from th: p;tient is 1::: th:2 00 u: ;fiv 20 mr :: per h:: :: di:::n:: :: :n; m;t:r, er 21- (b) th: ::tivity in the p: icnt is 1::: than 1.11 00; (00 mci;.)
22 23 NOTER The Nuclear Reculatory commission Reculatorv Guide B.39, " Release of 24 Patients Administered Radioactive Materials." demeribes methods for calculatina 25 doses to other individuals and contains tables of activities not likelv to cause 26 doses exceedino 5 mSv (0.5 rem).
21
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4 28 (2) (A]Iha licensee shall (nct utheri:: r:1:::: frc : nfin : nt f: #'d 35
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1 :C$i;;l 00;; Of ; p;;i;;; CI ini;tesed a p;.- .;;;;t ig1;;; g.til th; ;;;;;;d
- 2. f:C; ;;;; f.a th; p;;i;;; i; 1;;; th; '^ ut; (fi:: ::x; p;; h;;; :: O di;;;;;;
3 3 Of 0;; ;;;;.]nrovide the relammad individual with instructinna. includina
- 4. Written instructinna, on actions reenmmandad to maintain domes to ' other 5 Individumin am low as is remannahlv achiavabia if ehe totai affectiva don 6: asuivalent to any other individumi is 14km1v to exceed i msv f0.1 ram). If the 7 done to a breast-feedina 4nfant or child could exceed 1 mSv fo.1 ram) ammumina 8 there wara no interruntion of bramat-fandina. the instructions shall als
-9 include; I
- -10 -(a) auldance on ehm interruntion or dime 3neinuation of br a t-feedina. and ./.
11 (b) information on the ennmanuances of failure to folio: the auidanea. /
12 (3) The licanmaa shall maintain a record of the hacia for murhnrizina the [Ae 13 reimana of an individual. for thraa vaara af ter the data of relaana. if the total 14 effectiva done asuivalent in emiculated bvt
.15 4
fa) usina che retained activity rather than the activity administered.
[
16 'fb) usino an ocennancv factor less than o.2s at i matar. k 17 .Lc) us4no che biolooiemi or affectiva half-life. or V
- 18 - (d) ennsiderina the ahlaldina by timmua.
-19. (4) The liennmaa shall maintain a record. for three vaars af ter the data J.hj 20 of relaana. eh=t instructions wara nrovided to a breast-feedina woman if the I
~21 M *en done to the infant or child f rom continued breast-f andina could rudI.
1 22 in a total affectiva done mouivalent exceedina s msv fo.s ram).
- 23 1
24 R313-32-80. Technical Requirements that Appi.y to the Providers of Mobile Nuclear 25 Medicine service. (h )
26 A licensee providing mobile nuclear medicine service shall:
1- 27 (1) transport to each address of use only syringes or vials containing 28 prepared radiopharmaceuticals or radiopharmaceuticals that are intended for
) 36 r
. + o
- 0 1 reconstitution of radiopharmaceutical kits; 2 (2) bring into each address of use all radioactive material to be used
.3 .and, before leaving, remove all unused radioactive material and all associated 4 waste; 5 (3) secure or keep under constant surveillance and imediate control all 6 radioactive material when in transit or at an address of use;
~7 (4) check survey instruments and dose calibrators as described in R313 8 .50 and R313-32-51 and check all other transported equipment for proper function 9 before medical use at each address of uses 10 (5) carry a radiation detection survey meter in each vehicle that is being 11 used to transport radioactive material, and, before leaving a client address of-12 use, survey all radiopharmaceutical areas of use with - a radiation detection 13 survey meter to ensure that all radiopharmaceuticals and all associated waste 14- have been removed; and 15 (6) retain a record of each survey required in R313-32-80(5) for three 16- years. The record shall include the date of the survey, a plan of each area that 17 was surveyed, the measured dose rate at several points in each area of use 18 expressed in micros 1 everts or millirems per hour, the instrument used to make the 19 survey, and the initials of the individual who performed the survey.
-20 21- R313-32-90. storage of volatiles and cases. 4 -[
0 22 A licensee shall store volatile radiopharmaceuticals and radioactive gases 23 in the shipper's radiation shield and container. A licensee shall store a multi-24 dose container in a fume hood after drawing the first dosage from it.
(c 0 26 R313-32-92. Decay-In-storage. 4 27 (1) A licensee may hold radioactive material with a physical half-life of 28 less than 65 days for decay-in-storage before disposal in ordinary trash and is 37
. .. _ . ~ _ . .
-e- e 1 : exempt from the requirements of R313-15-1001 if it 2 (a) holds radioactive material for decay a minimum of ten half-lives; 3 (b) monitors radioactive material at the container raface before disposal 4 as ordinary trash and determines that its radioactivity cannot be distinguished 5 from the background radiation level with a radiation detection survey meter set 6 on its most sensitive scale and with no interposed shielding; 7 (c) removes or obliterates all radiation labels; and 8 (d) separates and monitors each generator column individually with 9 radiation shielding removed to ensure that it has decayed to background radiation 10 level before disposal.
11 (2) A licensee shall retain a record of each disposal permitted under 12 R313 92 (1) for three years. The record shall include the date of the
~
13 disposal, the date on which the radioactive material was placed in storage, the 14 radionuclides disposed, the survey instrument used, the background dose rate, the 15 dose rate measured at the surface of each waste container, and the name of the 16 -individual who performed the disposal.
17 18 h
R313-32-100. Use of Unsealed Radier m::;;i;;;;)aakiwnaeanial"/for' Uptake, o ) h[
19 Dilution and axcretion studies.
20 A licensee may use for untake. dilution. or excretion studies any unnealed 21 radioactive material'(in : r;di;pher-- ;;utical and f;r ; di;5n;;;i; u;; inv;1 ring 22 m;;;u.;;;nt; cf upt;h;, dilution, c: ;;;r;ti;n f;r which th; ";;d :nd Orug 23 Admini;tati;n (" A1 h;; ;;;;pt;d ; "::stic; cf Clai ;d Inv;;tig;ti;nci "x;- stion 24 for ; i;; Orug" (:10} cr opp n .;d ; "!!;u Orsi Appli;;ti;n" (!OA!.]erenared for 25 medical use that is eitherr 26 (1) obtained from a manufacturer or erenarer licenned oursuant to R313 27 75(9) or ecuivalent reguirements of the Nuclear Reculatory Commission or an 28 Acreement Stater or-38
4 o 1 (2) erenared by an autherized nuclear charmacist. a ehvmician who is an 2 authorized user and who meets the recuirements seecified in R313-32-920. or an 3 individual under the munervision of either as soecified in R313-32-25. '
4 r
5 R313-32-120. Possession of Survey Instrument. g g 6 A licensee authorized to use radioactive material for ur ake, uilusion, and 7 excretion studies shall have in its possession a portable radiation detection 4/
8 survey instrument capable of detecting dose rates over the range one usv (0.1 9 mrem) per hour to one mSv (100 mrem) per hour. _
10 dyag b H+C 2,1 R313-32-200. Use of unsealed Radio'[;h;=:: ticcic, 0 :::::: , 2nd 9 :g;n:
12 Nuejamiive Materia 17for Imaging and Localisation studies.
13 ((t A lic n:.:: :y u:; ::di ::tive rc crisi in : diagn;ati:
14 ::.di;ph: =cc:utic 1 :r gen : ter er :::g:nt hit f r pr:perr.ti:n ;,nd di gns ti:
15 un :: a radi:pharacccuticci centaining radi ::tiv rcteri:.1 :: which th rxd 16 and Drug Administrati n h:: ::::pted "::::ic: cf Claimed : vntigatiene 17 ===pti:n f :. '::u crug" (::=;, :pprov:0 : " ::u trug 7.pplic: tion" (: A; cr 18 :pproved : "Pr: duct 1.icensing Agrc::c.: (r: i! "
19 (: A lic n :: ch:11 clu : 5:ncr;ter; and pr:psr :::g:n: ':i t s in 20 :::;rd:::: .:ith the ranuf::tur r's instructi:ns.
21 :: A lin n;x rcy d:part frx the ranuf;;turu's inst = tiens for cluting 22 ga ntsr end p nparing :::g n kit; for which the T :d and O ng Administration 23 ("OA) h:: 2pproved : ":::u Drug Application" :OA) hy following the dirc icn cf 24 n authuired u;;r physician, 35 (:) n:12 :: :: d::: not rcli v: : linn::: f rw ::..rlying with 26 spplicchi: stat:, "r t, u eth:r f:d:=1 regulations.]A licennee may use for 27 immoino and localization studies any unsealed radioactive material erecared for 28 medical use that in either 39
e e
-1 (1) obtainad from a manufacturer er erenarer licensed nursuant to R313 22-2 75(9) or eaufvalent reauirements of + haa Nuclear Reaulatory Commiazion or an 3 Aare==-nt stater or 4 (2) *renared by an authnrized nuclear charmacist. a ohvnician who in an 5
authorized user and who meets the reauirements anecified in R313 32-920. or an 6 individu=1 und-r the munervision of either as anecified in R313 't2- 1 .
8 R313-32-204. Permissible Molybdenum-99 Concentration.- 4 42.
9 (1) A licensee shall not administer to humans a radiopharmaceutical 10 containing more.than 5.55 kBq (0.15 uC1) of molybdenum-99 per 37.0 MBq (one mci) 11 of technetium-99m.
18 (2) A licensee that uses molybdenum-99/ technetium-99m generators for 13
' preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99
. 14 concentration in each elute (r extract.
15- (3) A licensee that is required to measure molybdenum concentration shall 16
-retain a record of each measurement for three years. The record shall-include, 17 for each elution or extraction of technetium 99m, the measured activity of the 18 technetium expressed in megabecquerels or millicuries, the measured activity of 19 the molybdenum expressed in kilobecquerels or microcuries, the ratio of the 20 measures expressed as kilobecquerels er .nicrocuries of molybdenum per 21 megabecquerels or millicuries of techne'.ium, the time and date of the 22 measurement, and the in1tials of the individual who made the measurement.
23 _'
24 R313-32-205. Control of Aerosols and Gases. 4 '
R 25 Or]
(1) A licensee that administers radioactive aerosols or gases shall do so 26 in a room with a system that will keep airborne concentrations within the limits 27 prescribed in R313-15-201(4) and R313-15-301. The system shall either be 28 directly vented to the atmosphere through an air exhaust or provide for 40 m .
- . v.. ..
- l collection and decay or disposal of the aerosol or gas in a shielded container.
2 _(2) A licensee-shall administer radioactive gases in rooms that are at 3 negative pressure compared to surrounding rooms.
4 (3) Before receiving, using, or storing a radioactive gas, the licensee 5 shall calculate the amount of time needed after a spill to reduce the 6 concentration ir the room to the occupational limit as specified in R313-15-201, 7 The calculation shall be based on the highest activity of gas handled in a single 8 container, the air volume of the room, and the measured available air exhaust 9 rate.
10 (4) A licensee shall make a record cf the calculations required in R313-11 32-205(3) that includes the assumptions, measurements, and calculations made and 12 shall retain the record for the duration of use of the area. A licensee shall 13 .also post the calculated time and safety measures to be instituted in case of a 14 spill at the area of use.
15 (5) A licensee shall check the operation of reusable collection systems 16 each month, and c.easure the ventilation rates available in areas of radioactive 17 gas use each six months. Records of the measurement shall be kept for three 18 years.
19 20 Possession of Survey Instruments. O
~
R313-32-220.
t 21 A licensee authorized to use radioactive material for imaging and '
22 localization studies shall have in its possession a portable radiation detection 23 survey instrument capable of detecting dose rates over the range of one usv (0.1 4
24 mrem) per hour to one mSv (100 mrem) per hour, and- a portable radiation 25 measurement survey instrument capable of mecsuring dose rates over the range ten 26 usv (one mrem) per hour to ten mSv (1000 mrem) per hour, J
27 28 R313-32-300. Use of (ned6ephengneeewdeele] Unsealed Radioactive Materiali for 41
0 0 1- Therap{y)autfa m M =4stratian, 2 [r,.,, .
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13 .ppl i nh'. :::::, -- ;;d ;;hr hen;.'. ;.g.t:i:;;,) A licaname mav une for 14 theraneutic administration anv urmaaled radioactive material nranared for medical 15 -uma that in eithare 16- (1) obtained from a manufa-turer or pran=rer lican=ed nursuant to 9.313 17 -V 7s (9) er eauivalent reouirementa of th. Nuclear neaulaterv comm4 mmion or an 18- Aareamant stater or 19 (2) nrenared by an authorized nuclear charmacist. a ehvmician who is an 20 authnrized user and who meets the reauirements snacified in R313 32 920. t,r an 21 individn=1 undar the munervision of either am anecified in R313 32 25.
22 7
23' m313-32-310. safaty Instruetion.
T h 24 (1) A licensee shall provide radiation safety instruction for all #
25 personnel caring for the patient or the hum =n research subiect receiving /
26 radiopharmaceutical therapy and hospitalized for compliance with R313-32-75. To 27 satisfy this requirement, the instruction shall describe the licensee's 28 procedures for 42
~
. a 4
1 (a) patient or human rammarch subiect controll 2 .(b) visitor controls.
3 (c) contamination control; 4 (d) waste controls and S. (e) notification of the Radiation Safety Officer in case of the patient's 6 or tha hn==n rammarch subinets*= death or medical emergency.
7 (2) A licensee shall keep for three years a list of individuals receiving 8 instruction required by R313-32-310(1), a description of the instruction, the 9 date of instruction, and the name of the individual who gave the instruction. ,
, 10 11 R313-32-315. Safety Precautions. ( /
O 12 (1) For each patient or human remmarch subject receiving 13 radiopharmaceutical therapy and hospitalized for compliance with R313-32-75, a 14- licensee shall( ::-,17 uith th: f;11;.-ing) :
15 (a) provide a private room with a private sanitary facility 16 (b) post the patient's or the human research subiect's door with a 17 "Ic;= isn ] Radioactive Materials" sign and note on the door or in the patient's 18 or the human rammarch subiect * = chart where and how long visitors may stay in the /
19 patient's or the human research subiect's room;
-20 (c; authorize visits by individuals under age 18 only on a (p:ti:n by 21 p;ti:n ] case-bv-case basis with the approval of the authorized user after 22 consultation with the Radiation Safety Officer; '
23 (d) promptly after administration of the dosage, measure the dose rates 24- in contiguous restricted and unrestricted areas with a radiation measurement 25 survey instrument to demonstrate compliance with the requirements of R313-15, and 26 retain for three years a record of each survey that includes the time and date 27 of the survey, a plan of the area or list of points surveyed, the measured dose 28 rate at several points expressed in microsieverts or millirem per hour, the 43
e .
1~
instrument used to make the survey, and_the initials of the individual who made
'2- the survey;-
(e) either-monitor material and items removed from the patient's or the 4 human raamarch subiect's room to determine that their radioactivity cannot be 5_ distinguished from the natural background radiation level with a radiation 6 detection survey instrument met on its most sensitive scale and with no
-7 interposed shielding, or handle them as radioactive waste;-
8 (f) (p n.id; th; p;tica ith =di i : :::::y g;id=:; th:t uill h;1p ;;
9 k<.
p ndiatin d:n :: h:::;h;'.d m i n; =d th: p:hli: :: != n n :;;;hly 10 ::hi;;;hl: h:!;;; ::th;;icia; ;;1 :;; :: th; p;;i:::;
11 ';) ) curvey the patient's or tha human raamarch subiect's room and private ~
12 sanitary facility for removable contamination with a radiation detection survey 13 instrument-before assigning another patient-or human rammarch subiect to the 14 room. The room shall not be reassigned until removable contamination in less 15 than 4He]2RQ disintegratiens per minute ('.00n ci ;; 0,' M' ]per 100 square [
16 centimeters and
[
17 ([h]g) measure the thyroid burden of each individual who helped prepare 18 or administer a dosage of iodine-131 within three days after administering the 19- dosage, and-retain for the period required by R313-15-1107 a record of each 20 thyroid burden measurement, its date, the name of the individual whose thyroid 21 burden - was measured, and the initials of the- individual who made the 22 measurements.
23 (2) A licensee shall notify the Radiation Safety Officer immediately if 24 -the patient or the human research subiect dies or has a medical emergency.
25 26 -R313-32-320. Possession of Survey Instruments. * #
27 A licensee authorized to use radioactive material for radiopharmaceutical t 8 -/
28 therapy shall have in its possession a portable radiation detection survey 44
1 instrument capable.of detecting dose rates over the range one usv (0.1 mrem) per-2 hour to one mSv (100 mrem) peic hour, and a portable radiation measurement survey 3 instrument capable of measuring dose rates over the range ten uSv (one mrem) per 4 hour to ten mSv (1000 mrem) per hour.
R313-32 400. Use of sources for Brachytherapy. 4 0 7 A licensee shall use the 'following sources in accordance with the 8 manufacturer's radiation safety and handling instructions:
9- (1) Cesium-237 as a sealed source in needles and applicator cells for 10 topical, interstitial, and intracavitary treatment of cancer; 11 (2) Cobalt-60 as a sealed source in needles and applicator cells for 12 topical, interstitial, and intracavitary treatment of cancer; 13 (3) cold-198 as a sealed source in seeds for interstitial treatment of 14 cancer; 15 -(4) Iridium-192 as seeds encased in nylon ribbon for interstitial and 16 intracavitary treatment of cancer and as seeds for topical treatment of cancer; 17 (5) Strontium-90 as a sealed source in an applicator for-treatment of 18 superficial eye conditions; 19 (6) Iodine-125 as a sealed source in needs for topical, interstitial and 20 intracavitary treatment of cancer; 21 (7) Palladium-103 as a sealed source in seeds for interstitial treatment 22 of cancer. -
2 24 R313-32-404.
fGhym C J Release of Patients or Human Research subiects Treated With W 25 Temporary Implants.
26 (1) Immediately after removing the last temporary implant source from a 27 patient or a human research subiect, the licensee shall make a radiation survey [
28 of the patient or the human research subieet with a radiation detection survey /
45
e 0 1
instrument to confirm that all sources have been removed. The licensee shall not 2 release from confinement for medical care a patient or a human research subiect [
3 treated by temporary implant until all sources have been removed.
4 (2) A licensee shall retain a record of patient or human research subiect 5
surveys for three years. Each record shall include the date of the survey, the 6
name of the patient or the human research subiect, the dose rate from the patient 7 or the human rammarch subiect expressed as microsieverts ner hour V or millirem per [
8 hour9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> and measured at one meter from the patient or the human research nubject, [
9 the survey instrument used, and the initials of the individual who made the 10 survey, 12 R313 32-406.
(a By \,
Brachytherapy Sources Inventory. I gg [a 13 (1) Promptly after removing them f rom a patient, or a human research 14 subiect, a licensee shall return brachytherapy sources to the storage area, andJ I
i 15 count the number returned to ensure that all sources taken from the storage area $
16 have been returned.
17 (2) A . licensee shall trake a record of brachytherapy source use which sh:111 18 includei 19 ta) the names of the individuals permitted to handle the sourcet.;
20 (b) the nruber and activity of sources removed from storage, the patient's 21 cr_the human.Imassrch nubiect's name and room number, the time and datk they were V 22 removed f rom storage, the number and activity of the sources in storage af ter the 33 removal, and the initials of the individual who removed the sources from storage; 24 and 25 (c) the number and activity of sources re. turned to storage, the patient's 26 or the huan research subject's name and room number, the time and date they were V 27 returned to storage, the number and activity of sources in storage after the ,
28 return, and the initials of the individual who returned the sources to stcrage, ,
46
}
o .
O 1 (3) Imediately af ter implanting sources in a patient or a human research /
2 subiect the licensee shall make a radiation survey of the patient or the human V 3 ISaparch muSinct and the area of use to confirm that no sources have been 4 misplaced. The licensee shall make a record of each survey, 5 (4) A licensee anall retain the records required in R313 3's 406 (2) and'(3) 6 for three years.
8- R313 32-410. safety Instruction. 4 ~_ q
. JOfPr 9 (1) The licensee shall provide radiation safety instruction to all 10 personnel caring for the patient or tha human remmarch subiect undergoing implant J
11 therapy. To satisfy this requirement, the instruction shall describe 12 (a) size and appearance of the brachytherapy sources; 13 (b) safe handling and shielding instructions in case of a dislodged 14 source; 15 (c) procedures for patient-or human research subinet controll
- 16. (d) procedures for visit 7r controls and 17 (e) procedures for notification of the Radiation Safety Officer if the 18 patient or the human research subiect dies or has a medical emergency.
19 (2) A licensee shall retain for three years a record of individuals 20 receiving instruction required by R313 410 (1) , a description of the
-21 instruction, the date of instruction, and the name of the individual who gave the 22 instruction.
23 24 R313-32-415. Safety Precautions, d {
-25 (1j For each patient (e) or human research subieet receiving ihlant 26 therapy and not released f rom 'icennee control nursuant to R313-32-7s, a licensee
- 37. .shall:
[
28 (a) not quarter the patient or the human research subiect in the same room 47
1 with an (psti;;tl4ndividuni who is not receiving radiation therapy ( unl :: th; 2; +i;;;;;; ;;; d.- ;:::::: ;;...,11;;;; uith :h: ; g i;;;;;;; ;f n::: :: :::::: ::
3 : di ::x;; cf :n; :::;; f;;; th: i ,1:::) ;
4 (b) post the patient's or human rammarch subiect8m door with a "(0 ;ti;n /
5 -) Radioactive Materials" sign and note on tha door or in the patient's or human 6 rammarch subiect*a chart where and how long visitors may stay in the patient's 7 or hum =,rammarch subiect's room; 8 .c) authorize visits by individuals under age 18 only on a (p;ti;n by 9 p::i;n:)cana-bv-case basis with the approval of the authorized user after 10 consultation with the Radiation Safety Officer; 11 (d) promptly af ter implanting the material, survey the dose rates in 12- contiguous restricted and unrestricted areas with a radiation measurement survey 13 Jnstrument to demonstrate compliance with the requirements of R313-15, and retain 14 for three years a record of each survey that includes the time and date of the 15 survey, a plan of the area or list of points surveyed, the measured dose rate at 16- several points expreesed in microcieverts or millirem per hour, the instrument 17 used to make the survey, and the initials of the individual who made the survey; ,
1, h4 St & QW ;Q /\}ff kg, 19 y (e) provide the patient or the human research subiect with radiation 20 safety guidance that will help to keep radiation dose to household members and 21 the ptblic as low ~ as reasonably achievable before releasing the 22 (p;;i:nt) individual if the (psti;;tlinaividuni was administered a permanent 23 implant.
24 (2) A licensee shall notify the Radiation Safety Officer immediately if 25 the patient or the human research subiect dies or has a medical emergency. V 26' 27 R313-32-420. Possession of Survey Instrument. ( ct 0 28 A licensee authorized to use radioactive material for implant therapy shall 48
- .. -- . -. - . . .= .~ . _ . - - - - . - - -
. o 1 have in its possession a portable radiation detection survey instrument capable 2 of detecting dose rates over the range one uSv (0.1 mrem) _per hour to one mSv 3 (100 mrem) per hour, and a portable radiation measuremen't survey instrument 4 capable of measuring dose rates over the range ten usv (one mrem) per hour to ten 5 mSv (1000 mrem) per hour.
7 m313-32 500. Use of sealed sources for Diagnosis. ( -
e:L 0 8 A licensee shall use the following sealed sources in accordance with the
- 9. manufacturer's radiation safety and handling instructions:
2 10 (1) iodine-125, americium-241, or gadolinium-153 as a sealed source in a
^
11 device for bone mineral analysis; and 12- '(2) iodine-125 as a sealed sourcs in a p < iable imaging device.
13- > -
14 R313-32-520. Availability of survey Instrument. 4 A
[0 15 A licensee authorized to use radioactive material as a sealed source for 16 diagnostic purposes shall have available for use a portable radiation detection 17 survey instrument capable of detecting dose rates over the range one usv (0.1 18 mrem) per hour to one mSv per hour to (100 mrem) per hour or a portable radiation 19 measurement survey instrument capable of measuring dose rates over the range ten 20 usv (une mrem) per hour to ten mSv (1000 mrem) per hour. The instrument shall
'21 be calibrated in accordance with R313-32-51.
'22 23 R313-32-600. Use of a sealed source in a Teletherapy Unit d ,
S 0] j 24 The rules and provisions of R313-32-600 through R313-32-647 govern the use 25 of teletherapy units for medical use that contain a sealed source of cobalt-60 26 or cesium-137.
.L 27 28 m3-u. 05. aint. nance and .., air ...trictions. m
^
lCdepgb Ha t ~
49
1 only a person specifically licensed by the Executive Secretary, the Nuclear 2
Regulatory Commission, or an Agreement State to perform teletherapy unit 3 maintenance and repair shall's 4 (1) install, relocate, or remove a teletherapy sealed source or a
-5 teletherapy unit that contains a sealed sources or 6 (2) maintain, adjust, or repair the source drawer, the shutter or other 7 mechanism of a teletherapy unit that could expose the source, reduce the 8 shielding around the source, or result in increased radiation levels.
10 R313-32-606. License Amendments. y { f 11 In addition to the changes specified in R313-32-13, a licensee shall apply 1
12 for and shall receive a license amendment before:
13 (1) making any change in the treatment room shielding; 14 (2) making any change in the location of the teletherapy unit within the 15 treatment room; 16 (3) using the teletherapy unit in a manner that could result in increased 17 radiation levels in areas outside the teletherapy treatment room; 18 (4) relocating the teletherapy units or 19 (s) allowing an individual not listed on the licensee's license to perform 20 the duties of the teletherapy physicist.
21 /
-22' R313-32-610. Safety Instruction. $ L k
23 (1) A licensee shall post instructions at the teletherapy unit console.
24 To satisfy this requirement, these instructions shall inform the operator of:
25_ (a) the procedure to be followed to ensure that only the patient or the 26 human remmarch subiect is in the treatment room before turning the primary beam 27 of radiation on to begin a treatment or after a door interlock interruption; and 28 (b) the procedure to be followed ift 50 ,
l
-J
1 (1) the operator is unable to turn the primary beam of radiation off with 2 controls outside the treatment room or any other-abnormal operation occurs; and 3 (11) the names and telephone numbers of the authorized users and Radiation i
4 safety of ficer to be immediately contacted if the teletherapy unit or console 5 operaten abnormally.
6 (2) A licensee shall provide instruction in the topics identified in R313-1 7 32-610(1) to individuals who operate a teletherapy unit.
8 (3) A licensee shall retain for three years a record of individuals 9 receiving- instruction required by R313 610 (2 ) , a description of- the 10 instruction, the date of instruction, and the name of the individual whc gave the r
11 instruction.
12 f
13 m313-32-s15. -safety precautions.
ff$ ('
14 (1) A licensee shall control access to the teletherapy room by a door at 15- each entrance.
16 (2) A licensee shall equip each entrance to the teletherapy room with an 17 electrical interlock system that will:
18 (a) prevent the operator from turning the primary beam of radiation on 19 unless each-treatment room entrance door is closed; 20' (b) turn the primary beam of radiation off immediately when an entrance 21 door is opened; and 22 (c) prcvent the primary beam of radiation from being turned on following 23 an interlock interruption until all treatment room entrance doors are closed and 24 the beam on-off control is reset at the console.
. 25 (3) A licensee shall equip each entrance to the teletherapy room with a 26- beam condition indicator light.
27 (4) A licensee shall install in each teletherapy room a permanent 28 radiation monitor caparle of continuously monitoring be..a status.
51
1 -(a) A radiation monitor shall provide visible notice of a teletherapy unit
.8 _ malfunction that results-in an exposed or partially exposed source, and shall be 3
observable by an individual entering the teletherapy room.
4' .(b) ' A' radiation' o'.icer shall be equipped with a backup power supply 5.
separate from the power supply to the teletherapy unit. This backup power supply 6 1may be'a battery system.'
- 7 (c)- A radiation monitor shall be checked with a dedicated check source for 8: proper operation each day _before the teletherapy unit is used for treatment of 9- patients or hu==n raamarch subiacta.
10 (d) A licensee shall maintain a record of the check required by R313 11 615 (4 ) (c) for three years. The record shall iaclude the date of the check,
.12 notation that the monitor indicates when its detector is and is-not exposed, and 13 the initials of the individual who performed the check.
-14 (e) If a radiation monitor is inoperable, the licensee 'shall require 15 individuals entering the teletherapy room to use a survey. instrument-or audible
- e.larm _ personal dosimeter to monitor for malfunction of the source exposure 17=
mechanism that may result in an exposed or partially exposed source. The L18 instrument or' dosimeter shall be checked with a' dedicated check source for proper 19 operation at the beginning of each day of use. The licensee shall keep a record 20L as described in R313-32-615 (4) (d) .
21 (f) A licensee shall promptly repair or replace the radiation monitor if 22 it is inoperable.
23' (5) .A licensee shall construct or equip each teletherapy room to permit 24 continuous observation of the patient or eh= h"==n remaarch subinet from the 25 teletherapy unit console during irradiation.
.26 27 R313-32-620. Possession of Survey Instrument.
[- -
28 A licensee authorized to use radioactive material in a teletherapy unit 52
0 9
]
1 shall have in its possession either a portable radiation detection survey 2 instrument capable of detecting doce rates over the range one uSv (o.1 mrem) per 3 hour to one msv (100 mrem) per hour or a portable radiation measurement survey 4 instrument capable of measuring dose rates over the range ten uSv (one mrem) per 5 hour to ten msv (1000 mrem) per hour.
6 7 R313-32-630. Dosimetry Equipment. N [
Gkprw //
b M4 8 (1) A licensee shall have a calibrated dosimetry system available for use.
9 To satisfy this requirement, one of the fo31owing two conditions shall be met:
10 (a) The system shall be calibrated by the National Institute of Standards 11 and Technology or by a calibration laboratory accredited by the American 12 Association of Physicists in Medicine (AAPM). The calibration shall have been 13 performed within the previous two years and after any servicing that may have 14 affected system calibration.
15 (b) The system shall have been calibrated within the previous four years; 16 eighteen to thirty months after that calibration, the system shall have been 17 intercompared at an intercomparison meeting with another dosimetry system that 18 was calibrated within the past twenty-f our months by the National Bureau of 19 standards or by a calibration laboratory accredited by the AAPM. The 20 intercomparison meeting shall be sanctioned by a calibration laboratory or 21 radiologic physics center accredited by the AAPM. The results of the 22 intercomparison meeting shall have indicated that the calibration factor of the 23 licensee's system had not changed by more than two percent. The licensee shall 24 not use the intercomparison result to change the calibration factor. When 25 intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy 26 units, the licensee shall use a teletherapy unit with a cobalt-60 source. When 27 intercomparing dosimetry systems to be used for calibrating cesium-137 28 teletherapy units, the licensee shall use a teletherapy unit with a cesium-137 52
o- :..
1 fl. source.1 2- :(2) 'The licensee shall have available for use a dosimetry system for spot-
'3 check measurements. To satisfy this requirement, the system may be compared with
'4
- a system that ' has been calibrated in accordance with R313-32-630 (1) .
1 This-comparison shall have been performed within the previous year-and after each 6
servicing that may have effected system calibration. .The spot-check system may
' be the same system used to meet the requiremect in R313-32-630(1) ,
t 8 (3) The -licensee- shall retain a record of each calibration, l 9 intercomparison, and comparison for the duration of the license. For each '
L 10 l
calibration, intercomparison, or comparison, the record shall include the date, 11 the model numbers and serial. numbers of the instruments that were calibrated, 12, intercompared,:or compared as required by 5,313-32-630(1) and (2), the-correction 13' factor that was determined from the calibration or. comparison or the apparent
-- 14
' correction factor that was determined-from an intercomparison, the names of the 15 individuals who performed the calibration, intercomparison, or comparison, and 16 evidence - tnat the ' intercomparison meeting was- sanctioned by a calibration 17' . laboratory or radiologic physics center accredited by AAPM.
..181
-19 -R313-32-632.
Full Calibration 38eastrements. 4 t:L 0
'30 ~-(1) A licensee authorized to use a teletherapy unit for medical use shall
- 21 perform full calibration measurements on each teletherapy unit 22 (a) before the first medical use of the units and
' 2 3 '-
(b) before medical use under the following conditions:
(i) whenever spot-check measurements indicate that the output differs by
'25, more than five percent from the output obtained at the last full calibration 26- corrected mathematically for radioactive decay;
-27 (ii) following replacement of the source or following reinstallation of
'28 .the teletherapy unit in a new locations or 54
a .
4 1 (iii) following any repair of the teletherapy unit that includes removal 2 of the source or major repair of the components associated with the source 3 exposure assembly; and 4 (c) at intervals not exceeding one year.
5 (2) To satisfy the requirement of R313 -3 2 - 632 (1) , full calibration 6 measurements shall include determination of:
7 (a) the output within plus or minus three percent for the range of field 8 sizes and for the distance or range of distances used for medical use; i 9 (b) the coincidence of the radiation field and the field indicated by the l 10 light beam localizing device; 11 (c) the uniformity of the radiation field and its dependence on the 12 orientation of the useful beam; 13 (d) timer constancy and linearity over the range of use; 14 (e) on-off error; and l 15 (f) the accuracy of all distance measuring and localization devices in 16 medical use.
I 17 (3) A licensee shall use the dosimetry system described in R313-32-630(1) 18 to measure the output for one set of exposure conditions. The remaining 19 radiation measurements required in R313-32-63 2 (2 ) (a) may be made using a 20 dosimetry system that indicates relative dose rates.
21 (4) A licensee shall make full calibration measurements required by R313-22 32-632(1) in accordance with either the procedures recommended by the Scientific 23 Committee on Radiation Dosimetry of the American Association of Physicists in 24 Medicine that are described in Physics in Medicine and Biology Vol. 16, No. 3, 25 1971, pp. 379-396, or by Task Group 21 of the Radiation Therapy Committee of the 26 American Association of Physicists in Medicine that are described in Medical 47 Physics Vol. 10, No . 6, 1983, pp. 741-711, and Vol. 11, No. 2, 1984, p. 213.
28 (5) A licensee shall correct mathematically the outputs determined in 55
4 4 1
R313-32-632 (2) (a) for physical decay for intervals not exceeding one month for 2 cobalt-60 or six months for cesium-137.
3 (6) rull calibration measurement required in R313-32-632 (1) and physical 4
decay corrections required by R313-32-632(5) shall be performed by the licensee 5 teletherapy physicist.
6 (7) A licensee shall retain a record of each calibration for the duration 7 of the teletherapy unit source.
The record shall include the date of the 8 calibration, the manufacturer's name, model number, and serial number for both 9 the teletherapy unit and the source, the model numbers and serial numbers of the 10 instruments used to calibrats the teletherapy unit, tables that describe the 11 output of the unit over the range of field sizes and for the range of distances 1
12 used in radiation therapy, a determination of the coincidence of the radiation 13 field and the field indicated by the light beam localizing device, an assessment 14 of timer linearity and constancy, the calculated on off error, the estimated
{ 15 accuracy of each distance measuring or localization device, and the signature of I
! 16 the teletherapy physicist.
18 R313-32-634. Periodic Spot-Checks. <[f Q Of $
Q(
19 (1) A licensee authorized to use teletherapy units for medical use shall 20 perform output spot-checks on each teletherapy unit once in each calendar month 21 that include determination of.
22 (a) timer constancy, and timer linearity over the range of use; 23 (b) on-off errors 24 (c) the coincidence of the radiation field and the field indicated by the 25 light beam localizing device; 26 (d) the accuracy of all distance measuring and localization devices used 27 for medical user >
28 (e) the output for one typical set of operating conditions measured with 56 l
u
t 1 _ the dosimetry system described in R313-32-630(2); and 2 (f) the difference between the measurement made in R313-32-634 (2) (e) and 3 the anticipated output, expressed as_a percentage of the anticipated output (the 4 value obtained at last full calibration corrected mathematically for physical 5 decay).
6 (2) . A licensee shall perform measurements required by R313-32-634 (1) in 7 accordance with procedures established by the teletherapy physicist. That i 8- individual need not actually perform the spot-check measurements.
9 (3) A licensee shall have the teletherapy physicist review the results of 10 each spot-check within 15 days. The teletherapy physicist shall promptly notify i
11 the licensee in writing of the results of each spot-check.
l The licensee shall l 12 keep a copy of each written notification for three years.
13' (4) A licensee authorized to use a teletherapy unit for medical use shall 14 -perform safety spot-checks for each teletherapy facility once in each calendar 15 month that assure proper operation of
_ (a) electrical interlocks at each teletherapy room entrance; 17 (b) electrical or mechanical stops installed for the purpose of limiting g 18 use of the primary beam of radiation (restriction of source housing angulation ?
-19 or. elevation, carriage or stand travel and operation of the beam on-off 20 mechanism) 21 (c) beam condition indicator lights on the teletherapy unit, on the j 22 {
control console, and in the facility; 4 23 (d) viewing systemsi 24 (e) treatment room L ors from inside and outside t>3 treatment room; and (f) electrically assisted treatment room doors with the teletherapy unit
-26 electrical power turned off.
27 (5) A licensee shall arrange for prompt repair of any system identified 28 in R313-3 2-634 (4 ) that is not operating properly, and shall not use the 57
4JC EmAh 3E.-2E.e m -w- JPA.- a 4.*' ,.. A4 444.. 4- G.J4-4 -*---.La+J-e+- 4,-- -w&-DAM 4 h 6-. -*-*-s a v.-
4 4 1 teletherapy unit following door interlock malfunction until the interlock system 2 has been repaired.
3 . (6) A licensee shall retain a record of each spot-check required by R313-4 32-634(1) and (4) for three years. The record shall include the date of the 5 spot-check, the manufacturer's name, model number, and seria) number for both the 1
'6 teletherapy unit and source, the manufacturer's name, model number and serial 7 numbw of the instrument used to measure the output of the telethera;.f unit, an 8 assessment of linearity and constancy, the calculated on-off error, a 9 determination of the coincidence of the radiation field and the field indicated 10 by the light beam localizing device, the calculated on-off error,.the determined 11 accuracy of each distance measuring or localization device, the differenes 12 between the anticipated output and the measured output, notations indicating the 13 operability of each entrance door electrical interlock, each electrical or 14 mechanical stop,~each beam condition indicator light, the viewing system and 15 doors, and the signature of the individual who performed the periodic spot-check.
16
]
17 R313-32-636, safety checks for Teletherapy racilities. ( 0
-[ bd. ; -
18- (1) A licensee shall promptly check all systems listed in R313-32-634 (4) 19 for proper function after each installation of a teletherapy source and after 20 making any change for which an amendment is required by R313-32-606 (1) throug'n 21 (4).
22 (2) If the results of the checks required in R313-32-636 (1) indicate the 23 malfunction of a system specified in R313-32-634>4), the licensee shall lock the 24 . control console in the of f position and not use the unit except as may be
- 25. necessary to repnir, replace, or check the malfunctioning system.
26 (3) a licensee shall retain for three years a record of the facility 27 checks following installation of a source. The record shall include notations 28 indicating the operability of each entrance door interlock, each electrical or 58
1 mechanical stop, each beam condition indicator light, the viewing system, and 2 doors, and the signature of the Radiation Safety Officer.
4 R313-32-641. Radiation Surveys for Teleth6rapy Facilities. 4 0 5 _( 1) sofore medical use, after each installation of a-taletherapy source, 6 and af ter mak!ng any change. for which an amendment is required by R313-12-606(1) 7 through (4), the licensee shall perform radiation durveys with a portable 8 radiation measurement survey instrument calibrated in accordance with R313-32-51 l to verify that:
10 (a) the maximum and ave. rage dose rates at one meter from the teletherapy 11 source with the source in the off position and the collimators set for a normal 12 treatment field do not exceed 100 usv (ten mrem) per hour and 20 usv (two mrem) 13 -per hour, respectively;
,- 14 (b) with the teletherapy source in the on position with +,he largest
'15 clinically available treatment field and with a scattering phantom in the primary 16 beam of the radiation, that:
17- (1) radiation dose quantities per unit time in restricted areas are not 18 likely to cause personnel exposures in excess of the limits specified in R313 19 -201; and 20 .(ii) radiation dose quantities per unit time in unrestricted areas do not 21 exceed the limits specified in_R313-15-301.
-22 (2) If the results of the surveys required in R313-32-641(1) indicate any 23 radiation dose quantity per unit time in excess of the respective limit specified 24- in . R313 6 41 (1) , the licensew shall lock the control in the off position and 25 not use the unit 26 (a) except as may be necessary to repair, replace, or test the teletherapy 27 unit shielding or the treatment room shielding; or 28 (b) until the licensee has received a specific exemption pursuant to R313-59
t ll, 12-54.
2 (3) A licensee shall retain a record of the radiation measurements made 3 following installation of s source for the duration of the license. The record 4 shall include.the date <f the measurements, the reason the survey is required, 5 the manufacturer'a name, model number and serial number of the teletherapy unit, 6 the source, the instrument used to measure radiation levels, each dose rate
-7 measured around the teletherapy source while in the off position and the average 8 of all measurements, a plan of the areas surrounding the treatment room that were '
4 9 surveyed, the measured dose rate at several points in each area expressed in
- 10. microseverta or millirem per hour, the calculated maximum quantity of radiation 11= over a period of one week for each restricted and unrestricted area, and the ;
J. 12 -signature of the Radiation Safety Officer. ___,
13
( ~7of-. ) <
14' .R313-32-643. Modification of Teletherapy Unit or Room Before Beginning a 15 . Treatment Program.
-16 (1) If the survey required by R313-32-641 indicater that an individual in
- 17 an unrestricted area may be exposed to levels of radiation greater than those 18 permitted by R313-15-301, before beginning the treatment program t!t licensee 19- shall 20 (a). either equip the unit with stops or add additional radiation shleiding 21 to ensure compliance with R313-15-301(3);
- 22. -(b) perform the survey required by R313-32-641 again; and 23 (c) include in the report required by R313-32-645 the results of the 24 initial survey, a description of the f.cdification made to cowply with R313 i 25 643 (1) (a) , and the results of the second survey.
26 (2) As an alternative to the requirements set out in R313-32-643 (1) , a 27 . licensee may request a license amendment under R313-15-301(3) that authorizes L28 radiation levels in unrestricted areas greater than those permitted by R313 60
]
1 1 301(1). A licensee shall not begin the treatment program until the license 2 amendment has been issusd.
3 -
hcjo 4 R313 33 645. Reports of Telethorapy Surveys, checks, Tests and Measurements.
5 A licensee shall mail a copy of the records re Wired in R313 32 636, R313 ,
6 32 641, R313 32 643, and the output f rom the teletherapy source expressed as 7 coulombs / kilogram (roentgsns) or gray (rad) per hour at one meter from the source :
8 and determined during the full calibration required in R313 32 632 to the 9 Executf.ve secre*,ary within thirty days following completion of the action that 10 initiated the record requirement.
11 -
12 R313 33 647. Five-Year Inspection. ( ~
13 (3) A licensee shall have each teletherapy unit fully inspe ted and 14 service ( .,uring teletherapy source replac3 ment or at intervals not to exceed five 15 years, whichever comes first, to assure proper functioning of the source exposure 16 mechanism.
17 (2) This inspection and servicing shall o.ny be performed by persons 18 specifically licensed to do so by the Executive Secretary, the Nuclear Regulatory 19 Connission, or an Agreement state.
20 43) A licensee shall keep a record of the inspection and servicing for the 21 duration of the license. The record shall contain the inspector's name, the 22 inspector's license number, the date of inspection, the manufacturer's name and 23 model number and serial number for both the teletherapy unit and source, a list 24 of components inspected, a list of components serviced and the type of service, 25 a list of components replaced, and the signature of the inspector.
26
'27 R313 32 900. Radiation Safety Officer. d 4 0 28 Except as provided in R313 32-901, the licensee shall require an individual 61
1 fulfilling the responsibilities of the Radiation Safety Officer as provided in 2 R313-32 21 to be an individual who:
3 (1) is certified by:
6 (a) American Board of Health Physics in (G);;cmprehensive (H] health 5 (p) physics; 6 (b) American Board of Radiology; 7 (c) American Board of Nuclear Medicine; B (d)
Ame~ican Board of Ecience in (H) nuclear (H] medicines 9 (e) Board of Pharmaceutical Specialties in (H]Duclear (P] pharmacy;[-er) 10 (f) American Board of Medical Phvmics in radiation encoloov chysicar #
b/
11
.lgL.(Cr.;dir. -] Royal College of Physicians and surceens of canada _.in 12 (N]Duclear (M] medicine; (-ee) 13 (h) American Ontgenathic Board f (_padioloovt or r
gp' 14 (i) American osteopathic Board of Nuclear Medicinet or pp/
15 (2) has had classroom and laboratory trainir.g and experience as follows:
16 (a) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom mid laboratory training that includes:
17 (1) radiation physics and instrumentationi 18 (ii) radiation protection; 19 (iii) mathematics pertaining to the use and measurement of radioactivity; 20 (iv) radiation biology; and 21 (v) radAopharmaceutical cLemistry; and 22 (b) one year of full time experience as . radiation safety technologist 23 at a medical institution under the supervision of the individual identified as 24 the Radiation Safety Officer on a license issued by the Executive Secretary, 25 Nuclear Regulatory Commission or Agreement State license that authorizes the 26 medical use of radioactive materials or 27 (3) be an authorized user identified on the licensee's license.
20 62
o e b
1 R313 33-901. Training for amperienced Radiation safety officer.
- C3 2 An individual identified as a Radiation Safety Of ficer on a licensa issued 3 by the Exe9utive Secretary, Nuclear Regulatory Commission or Agreement State 4 before January 1, 1989, need not comply with the training requirements of R313-5 32-900. +
6 6 7 R313 33 910. Training for optake, Dilution, and macretion studies. -
t 8 Except as provided in R313-32 970 and R313-32 971, the licenses shall 9 requiro the authorized user of a radiopharmaceutical in R313 32100(1) to be a 10 physician who 11 (1) is certified in 82 (a) nuclear medicine by the American Board of Nuclear Medicine; !
1 13 (b) diagnostic radiology by the American Board of Radiology; / .
14 (c) diagnostic radiology or radiology by the American Osteopathic Board M l 15 of Radiology; (-ee) 16 (d) nuclear medicine by the [0;;;di;; 1 Royal College of Pilvaiciana and 17 surgeana of canadar or
.18 (a) American omtmannehie naard of wuei. r u.dican. tr nueimar medic 4n , or [
19 (2) has had classroom and laboratory training in basic radioisotope 20 handling techniques applictM.e to the use of prepared radiopharmaceuticals, and 21 supervised clinical experience as follows:
22 (a) 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of classroom and laboratory training that includes:
23 (1) radiation physics and instrumentation; 24' (ii) radiation protections 25 (iii) mathematics pertaining to the use and measurement of radioactivity; 26 (iv) radiation biology; and 27 (v) radiopharmaceutical chemistry; and 28- (b) 20 hours2.314815e-4 days <br />0.00556 hours <br />3.306878e-5 weeks <br />7.61e-6 months <br /> of supervised clinical experience under the supervision of 63
. . , . . , _ . . - - . . . ,_ .c _.
, , , _ _ _ _ . , _ , . . _ _ . . ,__,,.y., .,_c .,_....r..,,m_, , , , , . , _ _ . .-
e
- l 1 an authorized user and that includes:
l 2
(i) examining patients or hn==n raamarch subineta_and reviewing their case 3
histories to determine their suitability for radioisotope diagnosis, limitations, 4 or contraindications l
5 l (ii) aslecting the suitable radiopharmaceuticals and calculating and 6 measuring the dosages; V 7 (iii) administering dosages to patients or hu==n raamarch subjecta and 8 using syringe radiation shieldes 9 (iv) collaborating with the authorized user in the interpretation of 10 radionuclide test results; and /
11 (v) patient er human raaaarch subinet , follow-up; or 12 (3) has successfully completed a six-month training program in nuclear 13 medicine as part of a training program that has been approved by the 14 Accreditation council for oraduate Medical Education and that included classroom 15 and laboratory training, work exper:1ence, and supervised clinical experience in 16 the topics identified in R313-32-910(2) .
18 DN - e [5%
R313 32-920. Training for Imaging and Localisation Studies. V 19 Except as provided in R313 32-970 or R313-32 971, the licensee shall 20 require the authorized user of a radiophamaceutical, generator, or reagent kit 31 in R313-32-200 (1) to be a physician who:
22 -(1) is certified ins 23 (a) nuclear medicine by the American Board of Nuclear Medicine; 24 (b) diagnostic radiology by the American Board of Radiology; 25 (c) diagnostic radiolocy or radiology by the American osteopathic (b) Board 26 of Radiology;(-ee)
~27 (d) nuclear medicine by the (0:nzdi ) Royal College ef Physiciana_and 28 Surgeons.af canadas or 64
, V 1 f=1
'--rie=a cata^aat hi c maard of wueimar Madi ef aa in auelaar madiciaan er f/
l 2 (2) has - had classroom and laboratory training in basic radioisotope 3 handlir.g techniques applicable to the use of prepared radiopharmaceuticals, 4 generators, and reagent kits, supervised work experience, and supervised clinical-
-5 experience as fcilows:
l 6 (a) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:
7 (1) radiation physics and instrumentation 8 (11) radiation protections 9 (iii) mathematics pertaining to the use and measurement of radioactivity 10 (iv) radiopharmaceutical chemistrys and 11 (v) radiation biology; and 13 (b) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an 13 authorized user that includes:
14 (1) ordering, receiving, and unpacking radioactive materials safely and '
1 15 performing the related radiation surveyss 16 (ii) calibrating dose calibrators and diagnostic instruments and 17 performing checks for proper operation of survey meters; 18 (iii) calculating and safely preparing patient er hn==n rammarch subinet
- 19 dosages 20 (iv) using administrative controls to prevent the misadministration of 21 radioactive material; 23 (v) using procedures to contain spilled radioactive material safely and 23 using proper decontamination procedures; and 24 (vi) eluting technetium-9Pm from generator systems, measuring and testing
- 25. the elute for molybdenum 99 and alumina contamination, and processing the elute 16 with reagint kits to prepare technetium-99m labeled radiopharmaceuticals; and
- 27. (c) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised clinical experience under=the supervision of 3B the authorir.ed user that includeet 65
-~
1 (i) examining patients or hu==n raamarch subineta_and reviewir.g their case
(
8 histories to determine their suitability for radioisotope diagnosis, limitations, 3 or contraindications:
4 (ii) colecting the suitable radiopharmaceuticals and calculating and 5 measuring the dosagess 6 (iii) administering dosages to patients or human raamarch subiects and 7 using syringe radiation shie' 4 as 8 (iv) collaborating wit.h Ju uthorized user in the interpretation of 9 radioisotope test results and I
10 (v) patient or human research subinet_ follow ups or 11 (3) has successfully completed a six month training program in nuclear 12 medicine that has been approved by the Accreditation Council for Graduate Medical 13 Education and that included classroom and laboratory training, work experience, 14 and supervised clinical experience in the topics identif d.ed in R313-33 920(2) .
15 16 R313 32 930. Training for Therapeutic Use of Unmaalad 4---
17 Radio (phoemeeew dee&e)metive umtarimi.
Q p 18 Except as provided in R313-32 970, the licensee shall require the 19 authorized user of radiopharmaceuticals in R313-3J-300 to be a physician who:
20 (1) is certified by:
31 (a) (9)the American Board of Nuclear Medicine; 22 (b) (9)the American Board of Radiology in radiology. [ee) therapeutic 23 radiology. or radiatien encoloov, (--ee) 24 (c) nucinar medicin. bv [9]the (eene46en) Royal College [t] of Physicians 25 and surgeons of Canadas or 26 (d) the American Osteocathic Board of Radioloav after 1994f og
( 37 (2) has had classroom and 1.coratory training in basic radioisotope 28 handling techniques applicable to the use of therapeutic radiopharmaceuticals, 66
~
e
- O l
1 and supervised clinical experience as follows:
2 (a) to hours of classroom and laboratory training that includes: ,
3 (1) radiation physics and instrumentationt 4 (ii) radiation protections 5 (iii) mathematics pertaining to the use and measurement of radioactivity; ,
6 and 7 (iv) radiation biologys and 8 (b) supervised clinical experience under the supervision of an authorized 9 user at a medical institution that includes:
10 (i) use of iodine 131 for diagnosis of thyroid function and the treatment 12, of hyperthyroidism or cardiac dysfunction in ten individuals; and 18 (11) use of iodine 131 for treatment of thyroid carcinoma in three 13 individuals.
14 f 15 m313-32-933. Training for Treatment of styperthyroidism. .sG j8 16 Except as provided in R313 32-970, the licenses shall require the 17 authorized user of only iodine-131 for the treatment of hyperthyroidism to be a 18 physician with special experience in thyroid disease who has had classroom and 19 laboratory training in basic radioisotope handling techniques applicable to the 80 use of iodine-131 for treating hyperthyroidism, and supervised clinical 21 experience as follows:
22 (1) 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 that includes:
23 (a) radiation physics and instrumentations -'
24= (b) radiation protections 25 -(c) mather ties pertaining to the use and measurement of radioactivityi 26 and
.27 (d) radiation biology; and 28 (2) Supervised clinical experience under the supervision of an authorized 67
i i
i user that includes the use of iodine-131 for diagnosis of thyroid function, and 2 the treatment of hyperthyroidism in ten individuals. I 3
4 R313-33 934. TrainingforTreatmentofThyroidcarcinoma.I 0 l
5 Except as provided in R313-32 970, the licensee shall require- the 6 -authorized user of only iodine-131 for the treatment of thyroid carcinoma to be '
7 a physician with special experience in thyroid disease who has had classroom and 8 laboratory training in basic radioisotope handling techniques applicable to the 9 use of iodine-131 for treating thyroid carcinoma, and supervised clinical 10 experience as follows:
11 (1) 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 that includes:
12 (a) radiation physics and instrumentation #
13 (b) radiation protections 14 '( c) mathematics pertaining to the use 6.' measurement of radioactivitys 15 and 16 (d) radiation biology; and 17 (2) Supervised clinical experience under the supervision of an authorized 18 user that includes the use of iodine-131 for the treatment of thyroid carcinoma 19- in three individuals.
20 21 R313-32-940. Training for Use of Brachytherapy sources. d
{
32 Except as provided in R313-32-970 the licensee shall require t W thorized 23 user of a brachytherapy source listed in R313-32-400 for therapy to be a 84 physician who 25 (1) is certified ini 26 (a) radiology [,e--] therapeutic radiology. or radiation encoloov by the 87 American Board of Radiology 28 (b) radiation oncology by the American osteopathic Board of Radiology 68
0 .
.' i 1 (c) radiology, with specialization in radiotherapy, as a British
- Fellow 2 of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or 3 (d) therapeutic radiology by the canadian Royal college of Physicians and 4 surgeons; or 5 (2) is in the active practice of therapeutic radiology, has had classroom 6 and laboratory training in radioisotope handling techniques applicable to the 7 therapeutic use of brachytherapy sources, supervised work experience, and 8 supervised clinical experience as follows:
9 (a) 203 hours0.00235 days <br />0.0564 hours <br />3.356481e-4 weeks <br />7.72415e-5 months <br /> of classroom and laboratory training that includes:
10 (1) radiation physics and instrumentation; 11 (11) radiation protection; 12 (iii) mathematics pertaining to the use and measurement of radioactivity; 13 and 14 (iv) radiation biology; 15 (b) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an 16 authorized user at a medical institution that includes:
17 (i) ordering, receiving, and unpacking radioactive materials safely and 18 performing the related radiation surveys; 19 (ii) checking survey meters for proper operation; 20 (iii) preparing, implanting, and removing sealed sources; 21 (iv) maintaining running inventories of material on hand:
22 (v) using administrative controls to prevent the misadministration of 23 radioactive material; and 24 (vi) using emergency procedures to control radicactive material; and 25 (c) three years of supervised clinical experience that includes one year 26 in a formal training program approved by the Residency Review Committee for 27 Radiology of the Accreditation Council for Graduate Medical Education or the 28 Committee on Postdoctoral Training of the American Osteopathic Association, and 69
. e e
1 an additional two years of clinical experience in therapeutic radiology under the 2 supervision of an authorized user at a medical institution that includes:
3 (i) examining individuals and reviewing their case histories to determine 4 their suitability for brachytherapy treatment, and any limitations or 5 contraindicationes 6 (ii) selecting the proper brachytherapy sources and_ dose and method of 7 administrations l 8 (iii) calculating the dose; and 9 (iv) post administration follow-up and review of case histories in 10 collaboration with the authorized user.
la 1
12 R313-32 941. Training for Ophthalmic Use of strontium-90. O h 13 Except as provided in R313-32-970, the licensee shall require the 14 authorized user of only strontium-90 for ophthalmic radiotherapy to be a 15 physician' who is in the active practice of therapeutic radiology or 16 ophthalmology, and has had classroom and laboratory training in basic 17 radioisotope handling techniques applicable to the use of strontium-90 for 18 ophthalmic radiotherapy, and a period of supervised clinical training in 19 ophthalmic radiotherapy as follows:
30 (1) 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of classroom and laboratory training that includes:
21 (a) radiation physics and instrumentationi 22 (b) radiation protection; 23 (c) mathematics pertaining to the use and measurement of radioactivity; 34 and 25- (d) radiation biology.
26- (2) supervised clinical training in ophthalmic radiotherapy under the 27 supervision of an authorized user at a medical institution that includes the use 28 of strontium-90 for the ophthalmic treatment of five individuals that includes:
70
a 1 (a) examination of each individual to be treated; 2 (b) calculation of the dose to be administered; 3 (c) administration of the dose; and 4 (d) follow up and review of each individual's case history.
5 -
6-7 R313-32 950. Training for use of-sealed sources for Diagnosis. M Except as provided in R313-32-970, the licensee shall require the"
[
l 8 authorized user of a sealed source in a device listed in R313-32-500 to be a 9 physician, dentist, or podiatrist who 10 (1) is certified in 11 (a) radiology, diagnostic radiology, ter-) therapeutic radiologya 12 radiation encoloav by the American Board of Radiology; 13 (b) nuclear medicine by the American Board of Nuclear Medicine; (-ee) 14 (c) diagnostic radiology or radiology by the American Osteopathic Board 15 of Radiology; or 16 (d) nucinar medicin. bv the novai enllace of Phvaiciana and Euramena of 17- canadae or 18 (2) has had eight hours of classroom and laboratory training in basic
[ .19 radioisotope handling techniques specifically applicable to the use of the device 20 that includes:
21 (a) radiation physics, mathematics pertaining to the use and measurement 22 of radioactivity, and instrumentationi 23 (b) radiation bioicgy; 24 (c) radiation protection; and 25 -(d) training in the use of the device for the uses requested.
26 27 R313-32-960. . Training for Teletherapy. d 6]0 28 Except as provided in R313-32-970, the lir.ensee shall' require the 71 I
~ ,
. o
)
1 authorised user of a sealed source listed in R313 32-600 in a teletherapy unit 2 to be a physician who 3 (1) -is certified ini
-4 (a); radiology. (ee-) therapeutic radiology. or radiation annoinav by the
'5 -American Board of Radiology; 6- (b) radiation oncology by the American osteopathic Board of Radiology; 7 (c) radiology, with sptcialization in radiotherapy, as a British " Fellow 8
of the Faculty of Radiology" or " Fellow of the Royal College of Radiology"; or 9
(d) therapeutic radiology by the Canadian Royal College of Physicians and 10- surgeons; or 11 (2) is in the active practice of therapeutic radiology, and has had 12 classroom and laboratory training in basic radioisotope techniques applicable to 13 the use of a sealed source in a teletherapy unit, supervised work experience, and 14 ' supervised clinical experience as follows:
15 (a) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:
16 (i) radiation physics and instrumentation; 17 (ii) radiation protections
-18 (iii) mathematics pertaining to the use and measurement of radioactivity; 19 and 20 (iv) radiation biologf; 21 (b)- 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an
'-22: authorized user at a medical institution that includes:
' 23-(i) review of the full calibration measurements and periodic spot checks; 24 (ii) preparing treatment plans and calculating treatment times; 25 -(iii) using administrative controls _to prevent--misadministrations; -
26 (iv)--implementing emergency procedures to be followed in the event of the
- 27 abnormal operation of a teletherapy unit or console; and 28 -(v) checking and using survey metas; and-I 72
k.
b l
1 1 te) three years of supervised clinical experience that includes one year 3 in a formal training program approved by the Residency Review Committee for 3 Radiology of the Accreditation Council for Graduate Medical Education or the 4 Committee-on Postdoctoral Traink s of the American osteopathic Association and 5 an additional two years of clinical experience }n therapeutic radiology under the l 6 -supervision of an authorized user at a medical institution that includes 7 (i) examining individuals and reviewing their case histories to determine 8 their suitability for teletherapy treatment, and any limitations or 9 contraindications; 10 (11) selecting the proper dose and how it is to be administered 11 (iii) calculating the teletherapy doses and collaborating with the 12 authorized user in the review of patients' or h=mn research e-_uhincts' crogress 13 and consideration of the need to modify originally prescribod doses as warranted 14 by patients'-or human remaarch subinets' reaction to radiation; and
. 15 (iv) post-administration follow-up and review of case histories.
16 17 R313-32-961. Training for Teletherapy Physicist. g ~-
18 The licensee shall require the teletherapy physicist to be an individual 19 whoi 20 (1) is certified by the American Board of Radiolc zy( ;; ?.n ri;;. 2:: d ;f -
21 ":dic;l thf:i::) in:
22 (a) therapeutic radiological physics ( :: ::di.tien :n;;1;gy phf:i;:); /
- 23 (b) roentgen ray and gamma ray physiesi 24 (c) x-ray and radium physics; or 25 (d) radiological physicas or 26 (M is certified by the American Board of Me31 cal Phvmics in radiation 27 oncoloav chvalesr or 28 ( [911) holds a master's or doctor's degree in physics, biophysics, 73
e e 1 radiological physics, or health physics, and has completed one year of full time 2 training in therapeutic radiological physics and an additional year of full time 3 work experience under the supervision of a teletherapy physicist at a medical 4 institution that includes the tasks listed in R313-32-59, R313 32-632, R313-32 5 634 and R313 32 641.
R313 32-970. Training for Experienced Authorised Users. M j0 1
- f. Physicians, dentists, or podiatrists identified as authorized users for the 9 medical, dental, or podiatric use of radioactive material on a license issued by 10 the Executive Secretary, Nuclear Regulatory Commission, or Agreement State 11 license issued before January 1, 1989, who perfoun only those methods of use for 12 which they were authorized on that date need not comply with the training 13 requirements of R313 32-900 to R313-32 961.
14 15 R313 32 971. Physician Training in a Three Month Program. 4 -
h 16 A physician who, before October 1, 1988, began a three month nuclear 17 medicine training program approved by the Accreditation council for Graduate 18 Medical Edacation and has successfully completed the program need not comply with 19 the requirements of R313-32-910 or R313-32 920.
21 R313 32 972. V2kMd$wft? '
Recentness of Training.
i I[cdev g i
22 .The training and experience specified in R313-32 9[M)00 throuch R313 23 2A1_shall have been obtained within the (Ave]seven years preceding the date of
.24 application or the individual shall have had related continuing education and 25 experience since the.reqv;"od training and experience was completed.
8 27 m313-32-sao.
(Trainine for a Nnh
~
C~i {pF ik &zj) del'eTr-~th rimea ca t oc ; i annacist. W} -
v f
28 The licensee shall recuire the authorized nuclear charmacist to be a 74
o?e e
e 1 aka -aaint whan 2 fil han muerant hamed eartifientian an a nueimar ahnemmelat by the kamed 3 of Dhammamut iemi aamalaitiam. or 4 f,1 f ai han ea-minted 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured aduentinnal nremram [
5 --- aanniatin- of both, 6 diamette trainina in the faiinwine aramai ft)
V 7 (A) radictinn nhumfem and <=mtro- -catinn,
/
8' (3) radiatinn nrotectioni
/
9 fel multhamatien martainine to the uma and mammuramant of radinactivitvr /
10 .tn) A=1 =tev of l -da --d =m- -m
--A* s l f or mad f eal uma, and
/
11 radiation bioinavn and 12 fut
/
(11) au-eviana annerinnen in a nuriane charmaev involvina the folinwina, s/
13 (1) ahinnina. recalvina. and narformina reinted radiation survavat 14' fB) usina and narformine chacka for nroner anaration of dama calibratorm.
15 murvav matara. and. If annronriate. in=tru-anen used'to me==ura minha- or beta- V 16 a=4etina radianuelida=,
17 fc) exieuintine. ammavina. and safeiv nranarina dommaan for natients or /
'18 hu==n rammarch subineta,
.19 foi usin- ad-4nt trative centro 1. to avoid mistaken in the ad=4nimeration /
20 gi radinamatum matarini, 21 tai usina r.roendures to oravant er =4n4=4mm contamination and umana oroner /
-22 daennta=4 nation eroemduras, and 23 (b) ham obtained written eartification. mianed by a oracanter authorized /
24 nueimme nharmacist. that thm =have trainina hm= baan natinfmeteriiv comniated and /
25 that cha .individuni ham artW a - invai af comnetenev mufficient to /
-- 2 6 - -.. indanandantiv onarate a nucietr nharmaev.
l Wbh eyj
,, - ,.,,..... ,r.. 4.. f.r .ri....a ..c..r . . .t.. t
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75
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X n .h U' Y %am o i W_
_ G '~
nnGgyCct /P[lihn-I 1
- & ci.,pTN; q /ff k W A l i eerisee mav anniv for and must receive a license amendment identifvino an 2 greerie nced nuclear charmacist an an authorized nuclear pharmacist before it 3 allown t ia individuni to work an an authori-ed nuclear pharmacist. A charmacist.
4 who has ,omeleted a structured educational erocram as seccified in R313-32 3 3 0f21fa) be f ora ' Janua ry 11 199s'and who in workiner in a nuclear charmaev wouirt 6
cualifv an an ereerienced nuclear chamacist. An ereerienced nuclear charmacist )
1 7 geed not comniv with the recuirements on preceptor statement (See R313 l 8 980f2)(b)) and recantness of trainino (See R313 32-972) to cualify as an 9 authorized nuclear charmacist.
10 b.o 11 R313-32-999. Resolution of Conflicting Requirements During Transition Feriod.
12 If the rules in R313-32 conflict with the licensee's radiation safety 13 program as identified in its license, and if that license was approved by the 14 Bureau of Radiation Control, Department of Health, before January 1, 1989, and 15 has not been renewed since January 1, 1999, then the requirements in the license 16 will apply. However, if the licensee exercises its privilege to make minor 17 changes in its radiation safety procedures that are not potentially important to 18 safety under R313-32-31, the portion changed shall comply with the requirements 19 of R313-32. At the time of license renewal and thereafter, these amendments to 20 R313-32 shall apply.
21 22 KEY: radioactive material, radionharmaceutiegl. brachytheraev. ng6earmadicing 23 (Meech 10, 199511111 19-3-104 24 19-3 108 25 26 27 76
)