ML20281A519
| ML20281A519 | |
| Person / Time | |
|---|---|
| Issue date: | 10/01/2020 |
| From: | Michelle Beardsley NRC/NMSS/DMSST |
| To: | |
| Beardsley M | |
| Shared Package | |
| ML20281A277 | List: |
| References | |
| Download: ML20281A519 (109) | |
Text
DRAFT 2 - 06/04/2020 1
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 2
Hazardous Materials and Waste Management Division 3
RADIATION CONTROL - USE OF RADIONUCLIDES IN THE HEALING ARTS 4
6 CCR 1007-1 Part 07 5
[Editors Notes follow the text of the rules at the end of this CCR Document.]
6 7
Adopted by the Board of Health June 17, 2020, effective date August 14, 2020 8
PART 7: USE OF RADIONUCLIDES IN THE HEALING ARTS 9
USE OF RADIONUCLIDES IN THE HEALING ARTS 10 Section A - General Information 11
7.1 Purpose and Scope
.Purpose and scope.
12 7.1.1 Authority 13 Rules and regulations set forth herein are adopted pursuant to the provisions of sections 25 14 108, 25-1.5-101(1)(l), and 25-11-104, CRS.
15 7.1.2 Basis and Purpose.
16 A statement of basis and purpose accompanies this part and changes to this part. A copy may be 17 obtained from the Department.
18 7.1.3 Scope.
19 This part establishes requirements and provisions for the production, preparation, compounding 20 and use of radionuclides in the healing arts and for issuance of licenses authorizing the medical 21 use of this material. These requirements and provisions provide for the protection of the public 22 health and radiation safety of workers, the general public, patients, and human research subjects.
23 The requirements and provisions of this part are in addition to, and not in substitution for, others 24 in these regulations.
25 7.1.4 Applicability.
26 The requirements and provisions of these regulations apply to applicants and licensees subject to 27 this part unless specifically exempted.
28 7.1.5 Published Mmaterial Iincorporated by Rreference.
29 Published material incorporated in Part 7 by reference is available in accord with 1.4.
30 7.1.5.1 Throughout this Part 7, federal regulations, state regulations, and standards or 31 guidelines of outside organizations have been adopted and incorporated by reference.
32 Unless a prior version of the incorporated material is otherwise specifically indicated, the 33 materials incorporated by reference cited herein include only those versions that were in 34 Commented [JJ28]:
EDITORIAL NOTE 1:
These side margin comments as shown here are not part of the rule and are for information only, with the intent to aid the reader in understanding the proposed changes in the draft regulations. All side margin comments will be removed prior to publication as a final rule and are not part of the rule.
EDITORIAL NOTE 2:
Most of the proposed changes in this draft rule are based on the 2018 changes to U.S. Nuclear Regulatory Commission (NRC) federal rules in 10 CFR Part 30, 32 and 35. Final NRC regulations may be found at: https://www.nrc.gov/reading-rm/doc-collections/cfr/. Links to specific CFR sections are also provided in the side margin comments for the draft rule.
Additionally, the changes to federal rule are summarized/consolidated in NRC Regulatory Action Tracking System (RATS) 2018-1 which is referenced in the side margin comments when applicable.
EDITORIAL NOTE 3:
Throughout the side margin comments for select provisions, the NRC compatibility category may be listed. Information on NRC compatibility may be found on page 6 of NRC procedure SA-200 at:
https://scp.nrc.gov/impeptoolbox/impepcompatibility.html.
EDITORIAL NOTE 4:
The NRC has issued implementation guidance on the federal regulations. These may be found at:
https://www.nrc.gov/docs/ML1817/ML18176A377.pdf Commented [JSJ29]: Note that adoption and effective dates are tentative and subject to change, pending Board of Health meeting schedule, final adoption of the rule, and the Colorado Register publication dates.
Commented [JSJ30]: Here and throughout the rule, a new section headers are added for consistency with the format of 10 CFR 35. For example, 10 CFR 35 has Subpart A. In Part 7, this is referred to as Section A.
Commented [JJ31]:
Provisions in section 7.1.5, are revised and amended for consistency with the Colorado Administrative Procedure Act (24-4-103(12.5)(a)(2), CRS) regarding documents incorporated by reference.
Document 1 HRG Page 30 of 138
effect as of the most recent effective date of this Part 7 (August 2020), and not later 35 amendments or editions of the incorporated material.
36 7.1.5.2 Materials incorporated by reference are available for public inspection, and copies 37 (including certified copies) can be obtained at reasonable cost, during normal 38 business hours from the Colorado Department of Public Health and Environment, 39 Hazardous Materials and Waste Management Division, 4300 Cherry Creek Drive 40 South, Denver, Colorado 80246. Additionally, 41 https://www.colorado.gove/cdphe/radregs identifies where the incorporated federal 42 and state regulations are available to the public on the internet at no cost. A copy 43 of the materials incorporated in this Part is available for public inspection at the 44 state publications depository and distribution center.
45 7.1.5.3 Availability from Source Agencies or Organizations.
46 (1)
All federal agency regulations incorporated by reference herein are 47 available at no cost in the online edition of the Code of Federal Regulations 48 (CFR) hosted by the U.S. Government Printing Office, online at 49 www.govinfo.gov.
50 (2)
All state regulations incorporated by reference herein are available at no 51 cost in the online edition of the Code of Colorado Regulations (CCR) 52 hosted by the Colorado Secretary of States Office, online at 53 https://www.sos.state.co.us/CCR/RegisterHome.do.
54 55 (3)
Copies of the standards or guidelines of outside organizations are 56 available either at no cost or for purchase from the source organizations 57 listed below.
58 59
- a. The Federal Policy for the Protection of Human 60 Subjects: hhs.gov or https://www.hhs.gov/ohrp/regulations-and-61 policy/regulations/common-rule/index.html or 62 U.S. Department of Health & Human Services 63 200 Independence Avenue, S.W.
64 Washington, D.C.20201 65 Phone: 1-877-696-6775.
66 67
- b. NUREG-1556, Vol. 9: nrc.gov or https://www.nrc.gov/reading-rm/doc-68 collections/nuregs/staff/sr1556/ or 69 U.S. Nuclear Regulatory Commission 70 Washington, DC 20555-0001 71 Phone: 1-800-368-5642.
72 7.2 Definitions.
73 As used in this part, these terms have the definitions set forth as follows:
74 Address of use means the building(s) identified on the license where radioactive material may 75 be produced, prepared, received, used or stored.
76 Area of use means a portion of an address of use that has been set aside for the purpose of 77 producing, preparing, receiving, using, or storing radioactive material.
78 Associate Radiation Safety Officer means, for the purposes of Part 7, an individual who:
79 (1)
Meets the requirements in Appendix 7A and 7.65; and 80 Commented [JJ32]: Definition added, consistent with 2018 amendments to 10 CFR Part 35.2 The addition of this definition will specifically permit the addition of one or more person(s) to serve as an associate to the primary radiation safety officer identified on a specific radioactive material license for medical use, provided they meet the applicable requirements of Part 7 or are already designated on another Department, NRC or agreement state license as such.
NRC Compatibility B NRC RATS 2018-1 Document 1 HRG Page 31 of 138
(2)
Is currently identified as an Associate Radiation Safety Officer for the types 81 of use of radioactive material for which the individual has been assigned 82 duties and tasks by the Radiation Safety Officer on:
83
- a.
A specific medical use license issued by the Department, NRC or an 84 Agreement State; 85
- b.
A medical use permit issued by an NRC master material licensee.
86 Authorized medical physicist (AMP) means an individual who meets the requirements of 87 Appendix 7B; or 88 (1)
Is identified as an authorized medical physicist or teletherapy physicist on:
89
- a.
A specific medical license issued by the Department, NRC, or 90 Agreement State; 91
- b.
A medical use permit issued by an NRC master material license; 92
- c.
A permit issued by an NRC or Agreement State broad scope medical 93 use licensee; or 94
- d.
A permit issued by an NRC master material license broad scope medical 95 use license 96 Authorized nuclear pharmacist (ANP) means a pharmacist who meets the requirements of 97 Appendix 7C; or 98 (1)
Is identified as an authorized nuclear pharmacist on:
99
- a.
A specific license issued by the Department, NRC, or Agreement State 100 that authorizes medical use or the practice of nuclear pharmacy; 101
- b.
A permit issued by an NRC master material license that authorizes 102 medical use or the practice of nuclear pharmacy; 103
- c.
A permit issued by an NRC or Agreement State broad scope medical 104 use licensee that authorizes medical use or the practice of nuclear 105 pharmacy; or 106
- d.
A permit issued by an NRC master material license broad scope medical 107 use permitee that authorizes medical use or the practice of nuclear 108 pharmacy; or 109 (2)
Is identified as an authorized nuclear pharmacist by a commercial nuclear 110 pharmacy that has been authorized to identify authorized nuclear pharmacists; or 111 (3)
Is designated as an authorized nuclear pharmacist in accordance with Part 3.
112 Authorized user (AU) means a physician, dentist, or podiatrist who meets the applicable 113 requirements of Appendix 7D through Appendix 7M; or 114 (1)
Is identified as an authorized user on:
115
- a.
A Department, NRC, or Agreement State license that authorizes the 116 medical use of radioactive material; 117 Document 1 HRG Page 32 of 138
- b.
A permit issued by an NRC master material license that is authorized to 118 permit the medical use of radioactive material; 119
- c.
A permit issued by an NRC or Agreement State specific licensee of 120 broad scope that is authorized to permit the medical use of radioactive 121 material; or 122
- d.
A permit issued by an NRC master material license broad scope 123 permitee that is authorized to permit the medical use of radioactive 124 material.
125 Brachytherapy means a method of radiation therapy in which plated, embedded, activated, or 126 sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by 127 surface, intracavitary, intraluminal or interstitial application.
128 Brachytherapy source means a radioactive source or a manufacturer-assembled source train or 129 a combination of these sources that is designed to deliver a therapeutic dose within a distance of 130 a few centimeters.
131 Client means, for mobile medical service, the person for whom, or in conjunction with whom, 132 medical service is provided.
133 Client's address means the address of use for the purpose of providing mobile medical service 134 in accordance with 7.27.
135 Dedicated check source means a radioactive source that is used to assure the consistent 136 response of a radiation detection or measurement device over several months or years.
137 Dentist means an individual licensed by a State or Territory of the United States, the District of 138 Columbia or the Commonwealth of Puerto Rico to practice dentistry.
139 Diagnostic clinical procedures manual means a collection of written procedures that describes 140 each method (and other instructions and precautions) by which the licensee performs diagnostic 141 clinical procedures; where each diagnostic clinical procedure has been approved by the 142 authorized user and includes the radiopharmaceutical, dosage, and route of administration, or in 143 the case of sealed sources for diagnosis, the procedure.
144 HDR, see high dose-rate remote afterloader.
145 High dose-rate remote afterloader (HDR) means a device that remotely delivers a dose rate in 146 excess of 12 gray (1200 rad) per hour at the treatment site.
147 LDR, see low dose-rate remote afterloader.
148 Low dose-rate remote afterloader (LDR) means a device that remotely delivers a dose rate of 149 less than or equal to 2 gray (200 rad) per hour at the treatment site (at the specified distance).
150 Management means the chief executive officer, or other individual having the authority to 151 manage, direct, or administer the licensee's activities, or such person's' delegate(s).
152 Manual brachytherapy means a type of therapy in which brachytherapy sources are manually 153 applied or inserted.
154 MDR, see medium dose-rate remote afterloader.
155 Medical institution means an organization in which two or more medical disciplines are 156 practiced.
157 Document 1 HRG Page 33 of 138
Medical event means an event that meets the criteria in 7.21.1 or 7.21.2.
158 Medical use means, for the purposes of Part 7, the intentional internal or external administration 159 of radioactive material or the radiation from radioactive material to patients or human research 160 subjects under the supervision of an authorized user.
161 Medium dose-rate remote afterloader (MDR) means a brachytherapy device that remotely 162 delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than, or equal to, 12 gray 163 (1200 rads) per hour at the treatment site (at the specified distance)point or surface where the 164 dose is prescribed.
165 Misadministration means an event that meets the criteria in 7.21.
166 Mobile medical service means the transportation of radioactive material to, or its medical use at, 167 the clients address and/or a temporary job site.
168 Nuclear medicine technologist (NMT) means an individual who meets the requirements of 169 Appendix 7N and who under the supervision of an authorized user prepares or administers 170 radioactive drugs to patients or human research subjects, or performs in vivo or in vitro 171 measurements for medical purposes.
172 Nuclear medicine technology means the science and art of in vivo and in vitro detection and 173 measurement of radioactivity and the administration of radioactive drugs to patients or human 174 research subjects for diagnostic and therapeutic purposes.
175 Ophthalmic physicist means an individual who:
176 (1)
Meets the requirements in 7.41.6.1(2) and 7.65; and 177 (2)
Is identified as an ophthalmic physicist on a:
178
- a.
Specific medical use license issued by the Department, NRC or an 179 Agreement State; 180
- b.
Permit issued by the Department, NRC or Agreement State broad 181 scope medical use licensee; 182
- c.
Medical use permit issued by a NRC master material licensee; or 183
- d.
Permit issued by a NRC master material licensee broad scope 184 medical use permittee.
185 Output means the exposure rate, dose rate, or a quantity related in a known manner to these 186 rates, from a brachytherapy source, or a teletherapy, remote afterloader, or gamma stereotactic 187 radiosurgery unit, for a specified set of exposure conditions.
188 Patient intervention means actions by the patient or human research subject, whether 189 intentional or unintentional, such as dislodging or removing treatment devices or prematurely 190 terminating the administration.
191 PDR, see pulsed dose-rate remote afterloader.
192 Pharmacist means an individual licensed by a State or Territory of the United States, the District 193 of Columbia or the Commonwealth of Puerto Rico to practice pharmacy. (See also Authorized 194 nuclear pharmacist) 195 Commented [JSJ33]: For consistency with NRC language in 10 CFR Part 35, medical event replaces the current misadministration term here and throughout the rule.
Commented [JJ34]: Updated for consistency with same definition in 10 CFR 35.2.
Compatibility D.
Commented [JSJ35]: This term is deleted here and is replaced by medical event, consistent with the terminology of 10 CFR 35.
Commented [JJ36]: Definition for Ophthalmic physicist added, consistent with 2018 amendments to 10 CFR Part 35.2.
The addition of this definition will specifically permit the addition of person(s) to serve as an ophthalmic physicist provided they meet the applicable requirements of Part 7 or are already designated on another Department, NRC or agreement state license for such use.
NRC Compatibility B NRC RATS 2018-1 Document 1 HRG Page 34 of 138
Physician means an individual licensed by a State or Territory of the United States, the District 196 of Columbia or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.
197 Podiatrist means an individual licensed by a State or Territory of the United States, the District 198 of Columbia or the Commonwealth of Puerto Rico to practice podiatry.
199 Preceptor means an individual who provides, directs or verifies training and experience required 200 for an individual to become an authorized user, an authorized medical physicist, an 201 authorized nuclear pharmacist, a Radiation Safety Officer, an Associate Radiation Safety 202 Officera radiation safety officer, an authorized user, an authorized medical physicist, an 203 authorized nuclear pharmacist, a nuclear medicine technologist, or a radiation therapy 204 technologist (see appendices 7A through 7O7M, and 7P).
205 Prescribed dosage means the specified activity or range of activity of a radioactive drug as 206 documented in:
207 (1)
A written directive as specified in 7.11; or 208 (2)
Accordance with the directions of the authorized user for procedures performed 209 pursuant to 7.30, 7.32, or 7.36.
210 Prescribed dose means:
211 (1)
For gamma stereotactic radiosurgery, the total dose as documented in the written 212 directive; 213 (2)
For teletherapy, the total dose and dose per fraction as documented in the 214 written directive; 215 (3)
For manual brachytherapy, either the total source strength and exposure time or 216 the total dose, as documented in the written directive; or 217 (4)
For remote brachytherapy afterloaders, the total dose and dose per fraction as 218 documented in the written directive.
219 Pulsed dose-rate remote afterloader (PDR) means a special type of remote afterloading device 220 that uses a single source capable of delivering dose rates (at the specified distance) in the high 221 dose-rate range, but:
222 (1)
Is approximately one-tenth of the activity of typical high dose-rate remote 223 afterloader sources; and 224 (2)
Is used to simulate the radiobiology of a low dose rate treatment by inserting the 225 source for a given fraction of each hour.
226 Radiation safety officer (RSO) means, for the purposes of Part 7, an individual who has 227 demonstrated sufficient knowledge to apply radiation protection regulations appropriately, who in 228 accord with 7.7 has been assigned such responsibility by the licensee, and who meets the 229 requirements in Appendix 7A; or 230 (1)
Is identified as a Radiation Safety Officer on:
231
- a.
A specific medical use license issued by the Department, NRC, or 232 Agreement State; or 233
- b.
A medical use permit issued by an NRC master material licensee.
234 Commented [JJ37]: Definition updated, consistent with 2018 amendments to 10 CFR Part 35.2.
The changes to this definition incorporate the Associate Radiation Safety Officer term as defined earlier in this section.
The reference to preceptors for nuclear medicine technologists is removed as this term is proposed for removal from Appendix 7N. The reference to preceptors for radiation therapy technologists is excluded since that term is only used in Appendix 7O which is proposed for deletion (in its entirety).
NRC Compatibility D NRC RATS 2018-1 Document 1 HRG Page 35 of 138
Radiation therapy technologist (RTT) means an individual who meets the requirements of 235 Appendix 7O and is under the supervision of an authorized user to perform procedures and apply 236 radiation emitted from sealed radioactive sources to human beings for therapeutic purposes.
237 Radiation therapy technology means the science and art of applying radiation emitted from 238 sealed radioactive sources to patients or human research subjects for therapeutic purposes.
239 Radioactive drug means any chemical compound containing radioactive material that may be 240 used on or administered to patients or human research subjects as an aid in the diagnosis, 241 treatment, or prevention of disease or other abnormal condition.
242 Sealed source means radioactive material that is permanently bonded or fixed in a capsule or 243 matrix designed to prevent release and dispersal of the radioactive material under the most 244 severe conditions which are likely to be encountered in normal use and handling.
245 Sealed Source and Device Registry means the national registry that contains the registration 246 certificates maintained by the Nuclear Regulatory Commission, that summarize the radiation 247 safety information for the sealed sources and devices and describe the licensing and use 248 conditions approved for the product.
249 Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic 250 guidance device to precisely deliver a dose to a treatment site.
251 Structured educational program means an accredited educational program designed to impart 252 particular knowledge and practical education through interrelated studies and supervised training.
253 Teletherapy, as used in this part, means a method of radiation therapy in which collimated 254 gamma rays are delivered at a distance from the patient or human research subject.
255 Temporary job site, as used in Part 7, means a location where mobile medical services are 256 confined to the mobile unit not at a licensed address of use.
257 Therapeutic dosage means a dosage of unsealed radioactive material that is intended to deliver 258 a radiation dose to a patient or human research subject for palliative or curative treatment.
259 Therapeutic dose means a radiation dose delivered from a sealed source containing radioactive 260 material to a patient or human research subject for palliative or curative treatment.
261 Treatment site means the anatomical description of the tissue intended to receive a radiation 262 dose, as described in a written directive.
263 Trunnion means a support bar sometimes used as a bearing instead of a socket.
264 Type of use means use of radioactive material as specified under 7.30, 7.32, 7.36, 7.40, 7.42, 265 7.48 or 7.62.
266 Unit dosage means a dosage that:
267 (1)
Is obtained or prepared in accordance with the regulations for uses described in 268 7.30, 7.32, or 7.36; and 269 (2)
Is to be administered as a single dosage to a patient or human research subject 270 without any further manipulation of the dosage after it is initially prepared.
271 Written directive means an authorized user's written order for the administration of radioactive 272 material or radiation from radioactive material to a specific patient or human research subject, as 273 specified in 7.11.
274 Commented [JSJ38]:
This definition is proposed for deletion as it is not used in the body of the rule, nor is it being used during licensing and compliance activities by the radiation program. The term is used in Appendix 7O, which is also proposed for deletion.
The term does not appear in 10 CFR 35.
(The term originated from SSRCR Part Z (2012).
Commented [JSJ39]:
This definition is not used in the body of the rule nor is it used in 10 CFR 35.
Document 1 HRG Page 36 of 138
GENERAL REGULATORY REQUIREMENTS 275 7.3 License Required.License required.
276 7.3.1 277 7.3.1.1 A person shallmay manufacture, produce, prepare, acquire, receive, possess, prepare, 278 use, or transfer radioactive material for medical use only in accordance with a specific 279 license issued by the Department, an Agreement State or NRC, or as allowed in 7.3.1.1 280 or 7.3.1.2.
281 7.3.1.2 A specific license is not needed for an individual who:
282 7.3.1.(1)
Unless prohibited by license condition, an individual may rReceives, 283 possess, uses, or transfers radioactive material in accordance with the 284 regulations in this part under the supervision of an authorized user as provided in 285 7.10, unless prohibited by license condition.; or 286 7.3.1.(2)
Unless prohibited by license condition, an individual may pPrepares 287 unsealed radioactive material for medical use in accordance with the regulations 288 in this part under the supervision of an authorized nuclear pharmacist or 289 authorized user as provided in 7.10, unless prohibited by license condition.
290 7.3.2 Provisions for the protection of Human Research Subjects.
291 A licensee may conduct research involving human subjects using radioactive material under the 292 following conditions:
293 7.3.2.1 For research conducted, funded, supported, or regulated by a federal agency which has 294 implemented The Federal Policy for the Protection of Human Subjects (Federal Policy),
295 the licensee shall:
296 (1)
Obtain prior informed consent from the human research subjects; and 297 (2)
Obtain prior review and approval of the research activities by an Institutional 298 Review Board in accordance with the meaning of these terms as defined and 299 described in the Federal Policy; or 300 7.3.2.2 For research not conducted, funded, supported, or regulated by a federal agency which 301 has implemented the Federal Policy, then:
302 (1)
The licensee shall apply for and receive a specific amendment to its Department 303 license before conducting such research. The amendment request shall include a 304 written commitment that the licensee will, before conducting research:
305 (a).
Obtain prior informed consent from the human research subjects; and 306 (b).
Obtain prior review and approval of the research activities by an 307 Institutional Review Board in accordance with the meaning of these 308 terms as defined and described in the Federal Policy; 309 7.3.2.3 A licensee not authorized pursuant to 3.11 shall apply for and receive approval of a 310 specific amendment to its Department license before conducting research involving 311 human subjects; 312 7.3.2.4 The research involving human subjects authorized in 7.3.2 shall be conducted using 313 radioactive material authorized for medical use in the license; and 314 Commented [JSJ40]: 7.3.1 is updated/realigned for consistency with the format and content of 10 CFR 35.11.
[NON-RATS ITEM]
Document 1 HRG Page 37 of 138
7.3.2.5 Nothing in 7.3.2 relieves licensees from complying with the other requirements in Part 7.
315 7.3.3 Nothing in this part relieves the licensee from complying with applicable FDA, other federal, and 316 state requirements governing radioactive drugs or devices.
317 7.3.4 Application for Llicense, Aamendment, or Rrenewal.
318 7.3.4.1 An application shallmust be signed by the applicant's or licensee's management.
319 7.3.4.2 An application for a new or renewal license for medical use of radioactive material as 320 described in 7.30, 7.32, 7.36, 7.40, 7.42, 7.48 or 7.62 must be made by:
321 (1)
Filing an original a completed Department Form R-12 (7C) that includes the 322 facility diagram, equipment, and training and experience qualifications of 323 the Radiation Safety Officer, Associate Radiation Safety Officer(s),
324 authorized user(s), authorized medical physicist(s), ophthalmic 325 physicist(s), and authorized nuclear pharmacist(s); and 326 (2)
Submitting procedures required by Form R-12 (7C), and 7.12, 7.15, 7.51, 7.58, 327 7.59, and 7.61, as applicable, and other procedures as requested by the 328 Department.
329 7.3.4.3 A request for a license amendment must be made by:
330 (1)
Submitting an original amendment request in letter format.
331 (2)
Submitting procedures required by 7.12, 7.15, 7.51, 7.58, 7.59, and 7.61, as 332 applicable, and other procedures as requested by the Department.
333 7.3.4.4 In addition to the requirements in 7.3.4.2 and 7.3.4.3, an application for a new license, 334 renewal license, or amendment for medical use of radioactive material as described in 335 7.62 must also include: information regarding any radiation safety aspects of the medical 336 use of the material that is not addressed in 7.1 through 7.29, as well as any specific 337 information on:
338 (1)
Radiation safety precautions and instructions;Any additional aspects of the 339 medical use of the material that are applicable to radiation safety that are 340 not addressed in, or differ from:
341 (a)
Section A through C (7.1 through 7.29);
342 (b)
Sections D through H (recordkeeping requirements);
343 (c)
Section I (7.65);
344 (d)
Appendix 7A, 7B, 7C and 7P; 345 (2)
Training and experience of proposed users; 346 (2)
Identification of and commitment to follow the applicable radiation safety 347 program requirements in Sections D through H that are appropriate for the 348 specific 7.62 medical use; 349 (3)
Any additional specific information on:
350 (a)
Radiation safety precautions and instructions; 351 Commented [JSJ41]: 7.3.4 is updated for consistency with the wording of 10 CFR 35.12.
The revised language clarifies what information must be included in the application process, including the newly added Associate RSO and Ophthalmic physicist definitions.
NRC Compatibility D (all provisions within 7.3.4)
NRC RATS 2018-1 Commented [JSJ42]: Note: due to structural differences, the Subparts of 10 CFR Part 35 do not exactly parallel the Sections of Part 7.
10 CFR 35.12(d)(1) specifies that the license or amendment application include additional aspects applicable to radiation safety that are not addressed in subpart A through C, L, and M.
For reference:
- Subparts A through C of the CFR parallel Part 7 Sections A through C.
- Subpart B of the CFR also includes the training requirements of 35.50, 35.51, 35.55, and 35.57. For Part 7, these training requirements are found in Appendices 7A, 7B, 7C, and 7P, and are called out separately.
- Subpart B of the CFR also includes the recentness of training requirements of 35.59 which is found in Section 7I (provision 7.65).
- Subpart L of the CFR contains the recordkeeping requirements which are found in Sections D through H of Part
- 7.
-Subpart M of the CFR contains the reporting requirements which are contained within Sections C through D of Part 7.
NRC Compatibility D Commented [JSJ43]: Subparts D through H as referenced in the equivalent requirement of 10 CFR 35.12(d)(2) parallel the requirements of Section D through H of Part 7.
Document 1 HRG Page 38 of 138
(3)
(b)
Methodology for measurement of dosages or doses to be 352 administered to patients or human research subjects; and 353 (4)
(c)
Calibration, maintenance, and repair of instruments and 354 equipment necessary for radiation safety.; and 355 (4)
Any other information requested by the Department in its review of 356 the application.
357 7.3.4.5 The applicant or licensee shall also provide any other information requested by the 358 Department in its review of the application.
359 7.3.4.65 An applicant that satisfies the requirements specified in 3.11 may apply for a 360 Type A specific license of broad scope.
361 7.3.5 Mobile Medical Service Administrative Requirements.
362 7.3.5.1 The Department shall license mobile medical services or clients of such services. The 363 mobile medical service shall be licensed if the service receives, uses or possesses 364 radioactive material. The client of the mobile medical service shall be licensed if the client 365 receives or possesses radioactive material to be used by a mobile medical service.
366 7.3.5.2 Mobile medical service licensees shall obtain a letter signed by the management of each 367 location where services are rendered that authorizes use of radioactive material at the 368 client's address of use. This letter shall clearly delineate the authority and responsibility of 369 both the client and the mobile medical service. If the client is licensed, the letter shall 370 document procedures for notification, receipt, storage and documentation of transfer of 371 radioactive material delivered to the client's address for use by the mobile medical 372 service.
373 7.3.5.3 A mobile medical service shall not have radioactive material delivered directly from the 374 manufacturer or the distributor to the client, unless the client has a license allowing 375 possession of the radioactive material. Radioactive material delivered to the client shall 376 be received and handled in conformance with the client's license.
377 7.3.5.4 A mobile medical service shall inform the client's management who is on site at each 378 client's address of use at the time that radioactive material is being administered.
379 7.3.5.5 A licensee providing mobile medical services shall retain the letter required in 7.3.5.2 for 380 3 years after the last provision of service.
381 7.3.5.6 A mobile medical service licensee shall, at a minimum, maintain the following documents 382 on each mobile unit:
383 (1)
The current operating and emergency procedures; 384 (2)
A copy of the license; 385 (3)
Copies of the letter required by 7.3.5.2; 386 (4)
Current calibration records for each survey instrument and diagnostic equipment 387 or dose delivery device in use; and 388 (5)
Survey records covering uses associated with the mobile unit during, at a 389 minimum, the preceding 30 calendar days.
390 Commented [JSJ44]: Provision replaced by revised 7.3.4.4(4).
Document 1 HRG Page 39 of 138
7.3.5.7 The mobile medical service shall designate and manage each area of use in the clients 391 facility as a restricted area while radioactive material is present. For each location where 392 radioactive materials will be routinely used, the licensee shall provide to the Department:
393 (1)
A diagram of the location of use, including information about the placement of 394 required postings; and 395 (2)
Calculation(s) or survey(s) results that demonstrate compliance with applicable 396 dose limits in 4.14 and 4.15 at the location of use.
397 7.3.5.8 The mobile medical service shall ensure that:
398 (1)
Supervision by an authorized user is in accordance with 7.10.1; 399 (2)
Radiation exposures to the clients personnel working in the client facility are:
400 (a)
Below the dose limits to members of the public listed in 4.14; or 401 (b)
The client's personnel are instructed as described in 10.3 and monitored 402 for exposure in accordance with 4.18 unless the licensee can 403 demonstrate that 4.18 does not apply.
404 7.3.5.9 A mobile medical service licensee shall maintain all records required by Parts 4 and 7 of 405 these regulations at a location within the Department's jurisdiction that is:
406 (1)
A single address of use:
407 (a)
Identified as the records retention location; and 408 (b)
Staffed at all reasonable hours by individual(s) authorized to provide the 409 Department with access for purposes of inspection; or 410 (2)
When no address of use is identified on the license for records retention, the 411 mobile unit:
412 (a)
Identified in the license; and 413 (b)
Whose current client's address of use and area of use schedule is 414 reported to the Department.
415 7.3.6 A licensee possessing a Type A specific license of broad scope for medical use, issued under 416 Part 3 of these regulations is exempt from:
417 7.3.6.1 The provisions of 7.3.4.4 regarding the need to file an amendment to the license for 418 medical uses of radioactive material as described in 7.62; 419 7.3.6.2 The provisions of 7.4.2 regarding the need to file an amendment before permitting 420 anyone to work as an authorized user, an authorized nuclear pharmacist or an authorized 421 medical physicist under the license; 422 7.3.6.3 The provisions of 7.4.5 regarding additions to or changes in the areas of use at the 423 addresses specifiedidentified in the application or onin the license; 424 7.3.6.4 The provisions of 7.5.1 regarding notification to the Department for new authorized users, 425 new authorized nuclear pharmacists and new authorized medical physicists; 426 Commented [JJ45]: Section updated for consistency with 2018 amendments to 10 CFR 35.15.
NRC Compatibility D (all of 10 CFR 35.15)
Commented [JJ46]: Updated for consistency with 10 CFR 35.15(c).
Document 1 HRG Page 40 of 138
7.3.6.5 The provisions of 7.5.2.1 for an authorized user, an authorized nuclear pharmacist, 427 an authorized medical physicist or an ophthalmic physicist; 428 7.3.6.6 The provisions of 7.5.2.5; and 429 7.3.6.57 The provisions of 7.14 regarding suppliers for sealed sources.
430 7.3.7 The Department may, upon application of any interested person or upon its own initiative, grant 431 such exemptions from the regulations in Part 7 as it determines are authorized by law and will not 432 endanger life or property or the common defense and security and are otherwise in the public 433 interest.
434 7.4 License Aamendments.
435 A licensee shall apply for and shall have received must receive a license amendment before the 436 licensee:
437 7.4.1 Before it receivesReceives, prepares, or uses radioactive material for a type of use that is 438 permitted under this part but that is not authorized on the licensees current license issued 439 pursuant tounder this part; 440 7.4.2 Before it permitsPermits anyone to work as an authorized user, authorized medical physicist, 441 ophthalmic physicist, or an authorized nuclear pharmacist under the license, except: in 442 accordance with the training and experience requirements specified in:
443 7.4.2.1 Appendix 7D through Appendix 7M for an authorized user for a specific type of use of 444 radioactive material;For an authorized user, an individual who meets the 445 requirements in Appendix 7P and one or more of the following: Section 7D1 of 446 Appendix D, Section 7E1 of Appendix E, Section 7F1 of Appendix F, Section 7G1 of 447 Appendix 7G, Section 7H1 of Appendix 7H, Section 7K1 of Appendix K, Section 7J1 448 of Appendix J, or Section 7M1 of Appendix M; 449 7.4.2.2 Appendix 7B for an authorized medical physicist;For an authorized nuclear 450 pharmacist, an individual who meets the requirements in Section 7C1 of Appendix 451 7C and 7.65; 452 7.4.2.3 Appendix 7C for an authorized nuclear pharmacist; andFor an authorized medical 453 physicist, an individual who meets the requirements in Section 7B1 of Appendix 454 7B and 7.65; 455 7.4.2.4 An individual who is identified as an authorized user, an authorized nuclear 456 pharmacist, authorized medical physicist, or an ophthalmic physicist on:
457 (1)
A NRC or Agreement State license or other equivalent permit or license 458 recognized by the Department that authorizes the use of radioactive 459 material in medical use or in the practice of nuclear pharmacy; 460 (2)
A permit issued by a NRC or Agreement State specific license of broad 461 scope that is authorized to permit the use of radioactive material in medical 462 use or in the practice of nuclear pharmacy; 463 (3)
On a permit issued by a NRC master material licensee that is authorized to 464 permit the use of radioactive material in medical use or in the practice of 465 nuclear pharmacy; or 466 (4)
By a commercial nuclear pharmacy that has been authorized to identify 467 authorized nuclear pharmacists.
468 Commented [JJ47]: Added for consistency with 10 CFR 35.15(e).
Commented [JJ48]: Added for consistency with 10 CFR 35.15(f).
Commented [JSJ49]: Language updates in section 7.4 are made consistent with 2018 changes to 10 CFR Part 35.13.
The recent revisions to 10 CFR Part 35 and this section apply the ophthalmic physicist designation.
NRC Compatibility D NCR RATS 2018-1 Commented [JSJ50]: For cross reference to 10 CFR 35:
- 7.65 = 10 CFR 35.59 (recentness of training)
- App 7D = 10 CFR 35.190 (uptake, dilution, excretion)
- App 7E = 10 CFR 35.290 (imaging and localization)
- App 7F = 10 CFR 35.390 (unsealed - written dir. req)
- App 7G = 10 CFR 35.392 (I-131 < 33 mCi)
- App 7H= 10 CFR 35.394 (I-131 > 33 mCi)
- App 7K = 10 CFR 35.490 (manual brachytherapy)
- App 7J = 10 CFR 35.590 (sources for diagnosis)
- App 7M = 10 CFR 35.690 (afterloaders, GSR)
Commented [JSJ51]:
App 7C = 10 CFR 35.55 (auth nuclear pharmacist)
Commented [JSJ52]:
App 7B = 10 CFR 35.51 (authorized medical phys)
Document 1 HRG Page 41 of 138
7.4.2.5 A physician, podiatrist, or dentist who used only accelerator-produced radioactive 469 materials, discrete sources of radium-226, or both, for medical uses or a nuclear 470 pharmacist who used only accelerator-produced radioactive materials in the 471 practice of nuclear pharmacy at a Government agency or Federally recognized 472 Indian Tribe before November 30, 2007 or at all other locations of use before 473 August 8, 2009, or an earlier date as noticed by the NRC, and for only those 474 materials and uses performed before these dates.
475 7.4.3 Before it Cchanges a Radiation Safety Officer, except as provided in 7.7.67.7.3; 476 7.4.4 Before it permits anyone to work as an Associate Radiation Safety Officer, or before the 477 Radiation Safety Officer assigns duties to an Associate Radiation Safety Officer that differ 478 from those for which this individual is authorized on the license; 479 7.4.45 Before it Rreceives radioactive material in excess of the amount or in a different physical or 480 chemical form, or receives a different radionuclide than is authorized on the license; 481 7.4.56 Adds to or changes the area(s) of use or address(es) of use identified in the application or on the 482 license, except as specified in 7.5.2.4; andBefore it adds to or changes the areas of use 483 identified in the application or on the license, including areas used in accordance with 484 either 7.30 or 7.32 if the change includes addition or relocation of either an area where PET 485 radionuclides are produced or a PET radioactive drug delivery line from the PET 486 radionuclide/PET radioactive drug production area. Other areas of use where radioactive 487 material is used only in accordance with either 7.30 or 7.32 are exempt; 488 7.4.7 Before it changes the address(es) of use identified in the application or on the license; 489 7.4.68 Before it Cchanges statements, representations, and procedures which are incorporated into the 490 license; or 491 7.4.79 Before it Rreleases licensed facilities for unrestricted use.
492 7.4.10 Before it revises procedures required by 7.51, 7.58, 7.59, and 7.61, as applicable, where 493 such revision reduces radiation safety; and 494 7.4.11 Before it receives a sealed source from a different manufacturer or of a different model 495 number than authorized by its license unless the sealed source is used for manual 496 brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and 497 for an isotope authorized by the license.
498 7.5 Notifications and maintenance of records.
499 7.5.1 A licensee shall provide to the Department required documentation of adequate radiation safety 500 training and experience under Appendix 7B for each authorized medical physicist pursuant to 501 7.4.2, under Appendix 7C for each authorized nuclear pharmacist, and under the applicable 502 appendix of Appendix 7D through Appendix 7M for each individual authorized user.A licensee 503 shall provide the Department, no later than 30 days after the date that the licensee permits 504 an individual to work under the provisions of 7.4.2 as an authorized user, authorized 505 medical physicist, ophthalmic physicist, or authorized nuclear pharmacist:
506 7.5.1.1 A copy of the board certification and, as appropriate, verification of completion of:
507 (1)
Training for the authorized medical physicist under 7B3 of Appendix 7B; 508 (2)
Any additional case experience required in 7F2.1(2)(f) of Appendix 7F for an 509 authorized user under 7.36; or 510 Commented [JSJ53]: Added for consistency with 10 CFR 35.13(d).
Commented [JSJ54]:
7.51 = 10 CFR 35.610 7.58 = 10 CFR 35.642 7.59 = 10 CFR 35.643 7.61 = 10 CFR 35.645 Commented [JJ55]: Updated for consistency with 2018 amendments to 10 CFR 35.14(a).
The proposed language allows for a 30 day window in which documentation must be provided to the Department.
Consistent with 7.4.2, certain individuals may work under the license prior to the licensee providing the necessary documentation.
NRC Compatibility D Commented [JSJ56]: 7.4.2 = 10 CFR 35.13(b)
Commented [JJ57]: Added for consistency with 10 CFR 35.14(a)(1).
7.5.1.1(1) = 35.14(a)(1)(i) 7.5.1.1(2) = 35.14(a)(1)(ii) 7.5.1.1(3) = 35.14(a)(1)(iii)
NRC Compatibility D CROSS
REFERENCES:
7B3 = 10 CFR 35.51(c) 7F2.1(2)(f) = 10 CFR 35.390(b)(1)(ii)(G) 7.36 = 10 CFR 35.300 7M3 = 10 CFR 35.690(c) 7.48 = 10 CFR 35.600 Document 1 HRG Page 42 of 138
(3)
Device specific training in 7M3 of Appendix 7M for the authorized user 511 under 7.48; or 512 7.5.1.2 A copy of the Department, NRC or Agreement State license, the permit issued by a 513 NRC master material licensee, the permit issued by a NRC or Agreement State 514 licensee of broad scope, the permit issued by a NRC master material license broad 515 scope permittee, or documentation that only accelerator-produced radioactive 516 materials, discrete sources of radium-226, or both, were used for medical use or in 517 the practice of nuclear pharmacy at a Government agency or Federally recognized 518 Indian Tribe before November 30, 2007, or at all other locations of use before 519 August 8, 2009, or an earlier date as noticed by the NRC for each individual whom 520 the licensee permits to work under the provisions of this section.
521 7.5.2 A licensee shall notify the Department in writing withinno later than 30 days after:
522 7.5.2.1 An authorized user, anauthorized medical physicist authorized nuclear pharmacist, a 523 Radiation Safety Officer, an Associate Radiation Safety Officer, an authorized 524 nuclear pharmacistmedical physicist, or Radiation Safety Officerophthalmic physicist 525 permanently discontinues performance of duties under the license or has a name 526 change; 527 7.5.2.2 The licensee permits an individual qualified to be a Radiation Safety Officer under 528 Appendix 7A and 7.65 to function as a temporary Radiation Safety Officer and to 529 perform the functions of a Radiation Safety Officer in accordance with 7.7.6.
530 7.5.2.23 The licensee's mailing address changes; 531 7.5.2.34 The licensee's name changes, but the name change does not constitute a 532 transfer of control of the license as described in 3.15.2 of these regulations; or 533 7.5.2.45 The licensee has added to or changed the areas of use identified in the 534 application or on the license where radioactive material is used in accordance 535 with either 7.30 andor 7.32 if the change does not include addition or 536 relocation of either an area where PET radionuclides are produced or a PET 537 radioactive drug delivery line from the PET radionuclide/PET radioactive 538 drug production area.; or 539 7.5.2.6 The licensee obtains a sealed source for use in manual brachytherapy from a 540 different manufacturer or with a different model number than authorized by its 541 license for which it did not require a license amendment as provided in 7.4.11. The 542 notification must include the manufacturer and model number of the sealed 543 source, the isotope, and the quantity per sealed source.
544 7.5.3 The licensee shall submit the documents required in 7.5.1 and 7.5.2 to the Department.
545 7.5.34 Maintenance of Records.
546 Each record required by this part must be legible throughout the retention period specified by 547 each Department regulation. The record may be the original, a reproduced copy, or a microform 548 provided that the copy or microform is authenticated by authorized personnel and the microform 549 is capable of producing a clear copy throughout the required retention period. The record may 550 also be stored in electronic media with the capability for producing legible, accurate, and 551 complete records during the required retention period. Records such as letters, drawings, and 552 specifications must include all pertinent information such as stamps, initials, and signatures. The 553 licensee shall maintain adequate safeguards against tampering with and loss of records.
554 7.6 License Iissuance.
555 Commented [JJ58]: Added for consistency with 10 CFR 35.14(a)(2)
NRC Compatibility D Commented [JJ59]: Updated for consistency with 10 CFR 35.14(b).
NRC Compatibility D Commented [JSJ60]:
CROSS
REFERENCES:
7A = 35.50 7.65 = 35.59 7.7.6 = 35.24(c)
Commented [JSJ61]: CROSS
REFERENCE:
7.4.11 = 10 CFR 35.13(i)
Document 1 HRG Page 43 of 138
7.6.1 The Department shall issue a license for the medical use of radioactive material if:
556 7.6.1.1 The applicant has filed Department Form R-12 in accordance with the instructions in 557 7.3.4; 558 7.6.1.2 The applicant has paid any applicable fee; 559 7.6.1.3 The applicant meets the requirements of Part 3 of these regulations; and 560 7.6.1.4 The Department finds the applicant equipped and committed to observe the safety 561 standards established by the Department in these regulations for the protection of the 562 public health and safety.
563 7.6.2 The Department shall issue a license for mobile services if the applicant:
564 7.6.2.1 Meets the requirements in 7.6.1, and in particular 7.3.5; and 565 7.6.2.2 Assures that individuals to whom radioactive drugs or radiation from implants containing 566 radioactive material will be administered may be released following treatment in 567 accordance with 7.26.
568 ADDITIONAL OVERALL REQUIREMENTS 569 Section B - General Administrative Requirements 570 7.7 Authority and Rresponsibilities for the Rradiation Pprotection Pprogram 571 7.7.1 In addition to the radiation protection program requirements of 4.5 of these regulations, a 572 licensee's management mustshall approve in writing:
573 7.7.1.1 Requests for license application, renewal, or amendments before submittal to the 574 Department; 575 7.7.1.2 Any individual before allowing that individual to work as an authorized user, authorized 576 nuclear pharmacist or authorized medical physicist; and 577 7.7.1.3 Radiation protection program changes that do not require a license amendment and are 578 permitted under 7.7.
579 7.7.2 A licensees management shall appoint a Radiation Safety Officer (RSO), who agrees in writing to 580 be responsible for implementing the radiation safety program. The licensee, through the RSO, 581 shall ensure that radiation safety activities are being performed in accordance with licensee-582 approved procedures and regulatory requirements. A licensees management may appoint, in 583 writing, one or more Associate Radiation Safety Officers (ARSO) to support the RSO. The 584 RSO, with written agreement of the licensees management, must assign the specific 585 duties and tasks to each ARSO. These duties and tasks are restricted to the types of use 586 for which the ARSO is listed on a license. The RSO may delegate duties and tasks to the 587 ARSO but shall not delegate the authority or responsibilities for implementing the 588 radiation protection program.
589 7.7.3 For up to 60 days each year, a licensee may permit an individual qualified to be a 590 Radiation Safety Officer, under Appendix 7A and 7.65, to function as a temporary 591 Radiation Safety Officer and to perform the functions of a Radiation Safety Officer, as 592 provided in 7.7.6, if the licensee takes the actions required in 7.7.2, 7.7.5, 7.7.6, and 7.7.7 593 and notifies the Department in accordance with 7.5.2.
594 Commented [JSJ62]: Section 7.7 is updated, consistent with 2018 updates to 10 CFR 35.24 NRC RATS 2018-1 Commented [JJ63]: Provision updated, consistent with 2018 updates to 10 CFR 35.24(b)
The amended language introduces the new Associate Radiation Safety Officer terminology and associated requirements.
NRC RATS 2018-1 NRC Compatibility: H&S (7.7.2 / 35.24(b))
Commented [JSJ64]: Provision 7.7.3 revised, consistent with 10 CFR 35.24(c). This provision replaces current 7.7.6.
CROSS
REFERENCES:
Appendix 7A = 10 CFR 35.50 7.65 = 10 CFR 35.59 7.7.2 = 10 CFR 35.24(b) 7.7.5 = 10 CFR 35.24(e) 7.7.6 = 10 CFR 35.24(g) 7.7.7 = 10 CFR 35.24(h) 7.5.2 = 10 CFR 35.35.14(b)
NRC RATS 2018-1 NRC Compatibility: D (7.7.3 / 35.24(c))
Document 1 HRG Page 44 of 138
7.7.4 A licensee may simultaneously appoint more than one temporary Radiation Safety Officer 595 in accordance with 7.7.3, if needed to ensure that the licensee has a temporary Radiation 596 Safety Officer that satisfies the requirements to be a Radiation Safety Officer for each of 597 the different types of uses of byproduct material permitted by the license.
598 7.7.35 A licensee shall establish in writing the authority, duties, and responsibilities of the Radiation 599 Safety Officer, and of the Alternate RSO, if required.A licensee shall establish the authority, 600 duties, and responsibilities of the Radiation Safety Officer in writing.
601 7.7.46 A licensee shall provide the Radiation Safety Officer sufficient authority, organizational freedom, 602 time, resources, and management prerogative, to:
603 7.7.46.1 Identify radiation safety problems; 604 7.7.46.2 Initiate, recommend, or provide corrective actions; 605 7.7.46.3 Stop unsafe operations; and 606 7.7.46.4 Verify implementation of corrective actions.
607 7.7.5 A license shall retain a record of actions taken pursuant to 7.7.1, 7.7.2 and 7.7.3 for 5 years, 608 including:
609 7.7.5.1 A summary of the actions taken (and a signature of licensee management) in accordance 610 with 7.7.1; 611 7.7.5.2 A signed copy of the RSOs agreement (including the signature of the RSO and licensee 612 management) to be responsible for implementing the radiation safety program, as 613 required by 7.7.2; and 614 7.7.5.3 A current copy of the authorities, duties and responsibilities of the RSO as required by 615 7.7.3.
616 7.7.7 A licensee shall retain a record of actions taken under 7.7.1, 7.7.2, and 7.7.5 as follows:
617 Records of authority and responsibilities for radiation protection programs.
618 7.7.7.1 A licensee shall retain a record of actions taken by the licensee's management in 619 accordance with 7.7.1 for 5 years. The record must include a summary of the 620 actions taken and a signature of licensee management.
621 7.7.7.2 The licensee shall retain a copy of both authority, duties, and responsibilities of 622 the Radiation Safety Officer as required by 7.7.5, and a signed copy of each 623 Radiation Safety Officer's agreement to be responsible for implementing the 624 radiation safety program, as required by 7.7.2, for the duration of the license. The 625 records must include the signature of the Radiation Safety Officer and licensee 626 management.
627 628 7.7.7.3 For each Associate Radiation Safety Officer appointed under 7.7.2, the licensee 629 shall retain, for 5 years after the Associate Radiation Safety Officer is removed 630 from the license, a copy of the written document appointing the Associate 631 Radiation Safety Officer signed by the licensee's management.
632 7.7.6 For up to sixty days each year, a licensee may permit an authorized user or an individual qualified 633 to be a radiation safety officer to function as a temporary Radiation Safety Officer and to perform 634 the functions of a Radiation Safety Officer, as provided in 7.7.4, provided the licensee takes the 635 actions required in 7.7.2, 7.7.3, 7.7.4 and 7.7.5.
636 Commented [JSJ65]: Provision 7.7.4 added, consistent with 10 CFR 35.24(d). This provision was previously omitted from Colorado rule.
CROSS
REFERENCE:
7.7.3 = 10 CFR 35.24(c)
Commented [JSJ66]: Language revised for consistency with the phrasing of 10 CFR 35.24(e). No change in requirements.
NRC Compatibility D Commented [JSJ67]: This provision has been replaced by new 7.7.7.
NRC Compatibility D Commented [JSJ68]: This provision combines the requirements found in 10 CFR 35.24(h) and 10 CFR 35.2024.
Provision 7.7.7.3 is new to 10 CFR 35 as a result of the 2018 CFR changes, and addresses the recordkeeping requirements pertaining to the (new) Associate Radiation Safety Officer position.
NRC RATS 2018-1 NRC Compatibility D CROSS
REFERENCES:
7.7.1 = 10 CFR 35.24(a) 7.7.2 = 10 CFR 35.24(b) 7.7.5 = 10 CFR 35.24(e)
Commented [JJ69]: This provision is replaced by NEW 7.7.3 (above).
Document 1 HRG Page 45 of 138
A licensee may simultaneously appoint more than one temporary RSO, if needed, to ensure that 637 the licensee has a temporary RSO that satisfies the requirements to be an RSO for each of the 638 different uses of radioactive material permitted by the license.
639 7.8 Radiation Ssafety Ccommittee.
640 7.8.1 Licensees that are authorized for one or more different types of radioactive material use under 641 7.36, 7.42, 7.48, or 7.62 shall establish a Radiation Safety Committee to oversee all uses of 642 radioactive material permitted by the license.
643 7.8.2 The Committee shall:
644 7.8.2.1 Include:
645 (1)
An authorized user of each type of use permitted by the license; 646 (2)
The Radiation Safety Officer 647 (3)
A representative of the nursing service 648 (4)
A representative of management who is neither an authorized user nor a 649 Radiation Safety Officer; and 650 (5)
Other members as the licensee deems appropriate.
651 7.8.2.2 Meet as necessary, but at a minimum shall meet at intervals not to exceed 6 months.
652 7.8.2.3 Maintain minutes of each meeting, including:
653 (1)
The date of the meeting; 654 (2)
Members present; 655 (3)
Members absent; and 656 (4)
Summary of deliberations and discussions.
657 7.9 Radiation Pprotection Pprogram Cchanges.
658 7.9.1 A licensee may revise its radiation protection program without Department approval if:
659 7.9.1.1 The revision does not require an amendment under 7.4; 660 7.9.1.2 The revision is in compliance with the regulations and the license; 661 7.9.1.3 The revision has been reviewed and approved by the Radiation Safety Officer, licensee 662 management and licensee's Radiation Safety Committee (if applicable); and 663 7.9.1.4 The affected individuals are instructed on the revised program before the changes are 664 implemented.
665 7.9.2 A licensee shall retain a record of each change for 5 years, including 666 7.9.2.1 A copy of the old and new procedures; 667 7.9.2.2 The effective date of the change; and 668 Commented [JSJ70]: This provision is replaced by NEW 7.7.4 (above).
Document 1 HRG Page 46 of 138
7.9.2.2 The signature of the licensee management that reviewed and approved the change.
669 7.10 Supervision.
670 7.10.1 A licensee that permits the receipt, possession, use, or transfer of radioactive material by an 671 individual under the supervision of an authorized user as allowed by 7.3.27.3.1.2(1) shall:
672 7.10.1.1 In addition to the requirements of 10.3 of these regulations, instruct the 673 supervised individual in the licensee's written radiation protection procedures, 674 written directive procedures, regulations of Part 7, and license conditions with 675 respect to the use of radioactive material; and; 676 7.10.1.2 Require the supervised individual to follow the instructions of the supervising 677 authorized user for medical uses of radioactive material, written radiation 678 protection procedures, written directive procedures, regulations of Part 7, and 679 license conditions with respect to the medical use of radioactive material.
680 7.10.2 A licensee that permits the preparation of radioactive material for medical use by an individual 681 under the supervision of an authorized nuclear pharmacist or physician who is an authorized 682 user, as allowed by 7.3.37.3.1.2(2), shall:
683 7.10.2.1 In addition to the requirements of 10.3, instruct the supervised individual in the 684 preparation of radioactive material for medical use, as appropriate to that 685 individual's use of radioactive material; and 686 7.10.2.2 Require the supervised individual to follow the instructions of the supervising 687 authorized user or authorized nuclear pharmacist regarding the preparation of 688 radioactive material for medical use, the written radiation protection procedures, 689 the regulations of Part 7, and license conditions.
690 7.10.3 Unless physical presence as described in other sections of Part 7 is required, a licensee who 691 permits supervised activities under 7.10.1 and 7.10.2 shall require an authorized user to be 692 immediately available by telephone within ten minutes to communicate with the supervised 693 individual, unless otherwise authorized by the Department with prior written approval.
694 7.10.4 A licensee who permits supervised activities under 7.10.1 and 7.10.2 is responsible for the acts 695 and omissions of the supervising authorized user and supervised individual(s).
696 7.10.5 A licensee who permits supervised activities under 7.10.1 and 7.10.2 shall require that the 697 administration of radioactive material or radiation from radioactive material under the 698 supervision of an authorized user be performed only by:
699 7.10.5.1 A physician; 700 7.10.5.2 An individual who meets the requirements of Appendix 7B or 7N; 701 7.10.5.3 An individual in training in medical physics while under personal 702 supervision of an individual meeting the requirements of Appendix 7B; 703 7.10.5.4 An individual in training in nuclear medicine technology while under 704 personal supervision of an individual meeting the requirements of 705 Appendix 7N; or 706 7.10.5.5 An individual otherwise authorized in writing by the Department, or through 707 license condition(s).
708 7.11 Written Ddirectives.
709 Commented [JJ71]: Updated to correct prior cross-reference and typographical errors and align with the renumbering of section 7.3.1. Formatting and alignment corrections are also made to this section.
Commented [JJ72]: Updated to correct a prior cross-reference error and align with the renumbering of section 7.3.1.
Commented [JSJ73]:
This is a new proposed requirement intended to strengthen the requirements for persons who most often administer radioactive materials or radiation to patients while under the supervision of an authorized user physician named on the license. Such individuals may include physicians who may be training on a particular type of use and are not yet named as authorized users on a license for that material; authorized medical physicists; and nuclear medicine technologists.
As a result of stakeholder feedback, the originally proposed language is modified and expanded to include individuals in training for medical physics and nuclear medicine and to permit case-by-case authorizations for certain allied health and medical professionals who may be involved with administration of radioactive materials. The Department recognizes that certain medical procedures may involve administration of radioactive materials under the supervision of an AU by persons other than a physician in training, authorized medical physicist, or nuclear medicine technologist. These other individuals may include neurodiagnostic technicians trained to perform injections during seizures, or other individuals who may be involved in sentinel node procedures. The proposed provision provides a mechanism for licensees to request and be granted authorization for individuals who do not meet the requirements of 7.10.5.1 through 7.10.5.4.
In all instances, the administration of radioactive materials is performed under the supervision of an authorized user named on the license in accordance with the requirements of 7.10.
This requirement is Colorado specific and is not found in 10 CFR 35.
Document 1 HRG Page 47 of 138
7.11.1 A written directive must be dated and signed by an authorized user, including the signatory's 710 printed or typed name, prior tobefore the administration of:
711 7.11.1.1 I-131 sodium iodide greater than 1.11 MBq (30 µCi), or 712 7.11.1.2 Any therapeutic dosage of radioactive material, or 713 7.11.1.3 Any therapeutic dose of radiation from radioactive material.
714 If, because of the emergent nature of the patients condition, a delay in order to provide a 715 written directive would jeopardize the patients health, an oral directive is acceptable. The 716 information contained in the oral directive must be documented as soon as possible in 717 writing in the patients record. A written directive must be prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the 718 oral directive.
719 7.11.2 The written directive must contain the patient or human research subject's name and the 720 following:
721 7.11.2.1 For an administration of a dosage of radioactive drug containing radioactive 722 material, the name of the radioactive drug containing radioactive material, 723 dosage, and route of administration; 724 7.11.2.2 For gamma stereotactic radiosurgery, the total dose, treatment site, and values 725 for the target coordinate settings per treatment for each anatomically distinct 726 treatment site; 727 7.11.2.3 For teletherapy, the total dose, dose per fraction, number of fractions, and 728 treatment site; 729 7.11.2.4 For high dose rate remote afterloading brachytherapy:, the radionuclide, 730 treatment site, dose per fraction, number of fractions, and total dose; or 731 7.11.2.5 For permanent implant brachytherapy:
732 (1)
Before implantation: the treatment site, the radionuclide, and the total 733 source strength: and 734 (2)
After implantation but before the patient leaves the post treatment recovery 735 area: the treatment site, the number of sources implanted, the total source 736 strength implanted, and the date; or 737 7.11.2.56 For all other brachytherapy, including LDR, MDR, and PDR:
738 (1)
Prior to Before implantation: the treatment site, the radionuclide, and dose; and 739 (2)
After implantation but prior tobefore completion of the procedure: the 740 radioisotoperadionuclide,; treatment site,; number of sources,; and total source 741 strength and exposure time (or the total dose); and date.
742 7.11.3 If, because of the emergent nature of the patient's condition, a delay in order to provide a written 743 directive would jeopardize the patient's health, an oral directive will be acceptable, provided that 744 the information contained in the oral directive is documented as soon as possible in writing in the 745 patient's record and a written directive is prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.
746 7.11.43 A written revision to an existing written directive may be made provided thatif the revision is dated 747 and signed by an authorized user prior tobefore the administration of the dosage of radioactive 748 Commented [JJ74]: Updated for consistency with the 2018 amendments to 10 CFR 35.40(a).
NRC Compatibility H&S NRC RATS 2018-1 Commented [JJ75]: This is not a new requirement but is relocated from prior Section 7.11.3 for consistency with the flow/format of 10 CFR 35.40.
Commented [JJ76]: Added for consistency with the 2018 amendments to 35.40(b)(6).
The proposed language provides specific written directive requirements applicable to permanent implant brachytherapy consistent with federal rule. The proposed language primarily shifts the requirements from dose based criteria to activity (source strength/radioactivity) based criteria.
NRC RATS 2018-1 NRC Compatibility H&S Commented [JJ77]: This provision is relocated to 7.11.1 for consistency with the flow/format of 10 CFR 35.40.
Commented [JJ78]: Updated for consistency with language of 10 CFR 35.40(c)(1).
NRC Compatibility H&S Document 1 HRG Page 48 of 138
drug containing unsealed radioactive material, the brachytherapy dose, the gamma stereotactic 749 radiosurgery dose, the teletherapy dose, or the next fractional dose.
750 7.11.57.11.3.1 If, because of the patient's condition, a delay in order to provide a written revision 751 to an existing written directive would jeopardize the patient's health, an oral 752 revision to an existing written directive will beis acceptable., provided that the 753 The oral revision ismust be documented as soon as possible in the patient's 754 record. and aA revised written directive ismust be signed by the authorized user 755 within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral revision.
756 7.11.64 The licensee shall retain a copy of each written directive and/or written revision to an existing 757 written directive for 3 years.
758 7.12 Procedures for Aadministrations Rrequiring a Wwritten Ddirective.
759 7.12.1 For any administration requiring a written directive, the licensee shall develop, implement, and 760 maintain written procedures to provide high confidence that:
761 7.12.1.1 The patient's or human research subject's identity is verified before each 762 administration; and 763 7.12.1.2 Each administration is in accordance with the written directive.
764 7.12.2 The procedures required by 7.12.1 must, at At a minimum, the procedures required by 7.12.1 765 must address the following items that are applicable for the licensee's use of radioactive material:
766 7.12.2.1 Verifying the identity of the patient or human research subject; 767 7.12.2.2 Verifying that the specific details of the administration areis in accordance with 768 the treatment plan, if applicable, and the written directive; 769 7.12.2.3 Checking both manual and computer-generated dose calculations; and 770 7.12.2.4 Verifying that any computer-generated dose calculations are correctly transferred 771 into the consoles of therapeutic medical units authorized by 7.48 or 7.62.
772 7.12.2.5 Determining if a medical event, as defined in 7.21, has occurred; and 773 7.12.2.6 Determining, for a permanent implant brachytherapy, within 60 calendar 774 days from the date the implant was performed, the total source strength 775 administered outside of the treatment site compared to the total source 776 strength documented in the post-implantation portion of the written 777 directive, unless a written justification of patient unavailability is 778 documented.
779 7.12.3 A licensee shall retain a copy of the procedures required under 7.12.1 for the duration of 780 the license.
781 7.13 Duties of Aauthorized Uuser and Aauthorized Mmedical Pphysicist.
782 7.13.1 A licensee shall assure that only authorized users for the type of radioactive material used:
783 7.13.1.1 Prescribe the radiopharmaceutical dosage and/or dose to be administered 784 through the issuance of a written directive or reference to the diagnostic clinical 785 procedures manual; and 786 Commented [JJ79]: Updated for consistency with 10 CFR 35.40(c)(2).
NRC Compatibility H&S Commented [JJ80]: Updated for consistency with wording of 10 CFR 35.41(b).
Commented [JJ81]: Updated for consistency with wording of to 10 CFR 35.41(b)(5).
Commented [JSJ82]: Consistent with the reformatting of 7.62, a reference to 7.62 is added.
Ref: NRC Letter 02/20/2020 Commented [JJ83]: Added for consistency with 2018 changes to 10 CFR 35.41(b)(5). This is a new provision in the CFR.
Requiring licensees to establish procedures to help evaluate for and report medical events allows the Department (and nationally, the NRC) to identify if similar issues/errors are occurring across facilities.
NRC RATS 2018-1 NRC Compatibility H&S CROSS
REFERENCE:
7.21 = 10 CFR 35.3045 Commented [JJ84]: Added for consistency with 2018 changes to 10 CFR 35.41(b)(6). This is a new provision in the CFR.
This requires licensees to include in their procedures, an evaluation of whether the placement of implanted sources is consistent with the post-implantation portion of the written directive.
NRC RATS 2018-1 NRC Compatibility H&S Commented [JSJ85]: 35.41 Added for consistency with 10 CFR 35.41(c) and the recordkeeping requirements of 10 CFR 35.2041. This provision was previously omitted from the rule.
NRC Compatibility D
[Non-RATS item]
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7.13.1.2 Direct, as specified in 7.10 and 7.12, or in license conditions, the administration 787 of radioactive material for medical use to patients or human research subjects; 788 7.13.1.3 Prepare and administer, or supervise the preparation and administration of 789 radioactive material for medical use, in accordance with 7.3.27.3.1.2(1), 7.3.37.3.1.2(2) 790 and 7.10; 791 7.13.2 A licensee shall assure that only authorized medical physicists perform, as applicable:
792 7.13.2.1 Measurements and calculations as described in 7.41; 793 7.13.2.2 Full calibration measurements as described in 7.54, 7.55, and 7.56; 794 7.13.2.3 Periodic spot checks as described in 7.58, 7.59 and 7.61; and 795 7.13.2.4 Radiation surveys as described in 7.57.
796 7.14 Suppliers for Sealed Sources or Devices for Medical Use.Suppliers for sealed sources or 797 devices for medical use.
798 For medical use, a licensee may only use:
799 7.14.1 Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with 800 a license issued pursuant to Part 3 of these regulations or the equivalent regulations of another 801 Agreement State, a Licensing State or the NRC; 802 7.14.2 Sealed source or devices non-commercially transferred from a Part 7 licensee or an Agreement 803 State or NRC medical use licensee; or 804 7.14.3 Teletherapy sources manufactured and distributed in accordance with a license issued pursuant 805 to Part 3 of these regulations, or the equivalent regulations of another Agreement State, a 806 Licensing State, or the NRC.
807 SPECIFIC REQUIREMENTSSection C - General Technical Requirements 808 7.15 Quality Control of Diagnostic Equipment.
809 7.15.1 Each licensee shall establish written quality control procedures for all diagnostic equipment used 810 for radionuclide studies.
811 7.15.2 As a minimum, quality control procedures and frequencies shall be:
812 7.15.2.1 Those recommended by equipment manufacturers; or 813 7.15.2.2 Procedures which have been approved by the Department.
814 7.15.3 The licensee shall conduct quality control of diagnostic equipment in accordance with written 815 procedures.
816 7.15.4 A licensee shall retain a record of each quality control test required by the written quality control 817 procedures for 3 years.
818 7.16 Possession, Use, and Testing of Instruments to Measure the Activity of Unsealed Radioactive 819 Materials.Possession, use, and calibration of instruments used to measure the activity of 820 unsealed radioactive material.
821 Commented [JJ86]: Updated to correct prior cross-reference errors and align with the renumbering of section 7.3.1.
Commented [JSJ87]: Minor changes to this provision, consistent with 10 CFR 35.49.
NRC Compatibility C
[NON-RATS ITEM]
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7.16.1 For direct measurements performed in accordance with 7.18, a licensee shall possess and use 822 instrumentation to measure the activity of unsealed radioactive materials prior to administration to 823 each patient or human research subject.
824 7.16.2 A licensee shall calibrate the instrumentation required in 7.16.1 in accordance with nationally 825 recognized standards or the manufacturer's instructions.
826 7.16.3 In addition to the calibration required in 7.16.2, the licensee shall at a minimum also perform tests 827 for constancy, linearity, and geometry dependence, as appropriate to demonstrate proper 828 operation of the instrument.
829 7.16.4 A licensee shall retain a record of each instrument calibration and test required by 7.16 for 3 830 years. The record shall include the:
831 7.16.4.1 Model and serial number of the instrument; 832 7.16.4.2 Date of the calibration and other tests; 833 7.16.4.3 Results of the calibration and other tests; and 834 7.16.4.4 Name of the individual who performed the calibration and other tests.
835 7.17 Calibration of Survey Instruments.Calibration of survey instruments.
836 7.17.1 A licensee shall ensure thatcalibrate the survey instruments used to show compliance with Part 4 837 and Part 7 have been calibrated before first use, annually at intervals not to exceed 12 months, 838 and following any repair that will affects the calibration. A licensee shall:
839 7.17.1.1 Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a 840 radiation source; 841 7.17.1.2 Calibrate two separate readings on each scale or decade that will be used 842 to show compliance; and 843 7.17.1.3 Conspicuously note on the instrument the date of calibration.
844 7.17.2 To satisfy the requirements of 7.17.1 the licensee shall:
845 7.17.2.1 Calibrate all required scale readings up to 10 mSv (1 rem) per hour with a 846 radiation source; 847 7.17.2.2 Have each radiation survey instrument calibrated as follows, or by acceptable 848 equivalent methods:
849 (1)
At energies appropriate for use and at intervals not to exceed 12 months or after 850 instrument servicing, except for battery changes; 851 (2)
For linear scale instruments, at 2 points located approximately one-third and two-852 thirds of full-scale on each scale; 853 (3)
For logarithmic scale instruments, at mid-range of each decade and at 2 points of 854 at least one decade; 855 (4)
For digital instruments, at 3 points between 0.02 and 10 mSv (2 and 1000 mrem) 856 per hour; and 857 Commented [JSJ88]: Language and format/flow is updated for consistency with 10 CFR 35.61 except as indicted below.
Proposed 7.17.1.1 parallels the existing requirement in 7.17.2.1 (below).
Proposed 7.17.1.3 parallels the existing requirement in 7.17.2.3 Although not found in 10 CFR 35, the phrase at intervals not to exceed 12 months is retained from the current rule as the radiation program believes it adds clarity to the requirement.
NRC Compatibility H&S: 7.17.1.1, 7.17.1.2, 7.17.2 NRC Compatibility D: 7.17.1.3, 7.17.3 Commented [JSJ89]: The requirement in 7.17.2.1 is replaced by 7.17.1.1 (above).
Commented [JSJ90]:
The requirements of 7.17.2.2 are not found in Part 35 and are deleted. Due to the various makes, models and design configurations of modern survey instruments, calibration requirements are generally best determined by the facility performing the calibration. Licensed facilities typically perform calibrations in accordance with standard practices and nationally accepted standards appropriate for the specific instrument.
Document 1 HRG Page 51 of 138
(5)
For dose rate instruments, so that an accuracy within plus or minus 20 percent of 858 the true radiation dose rate can be demonstrated at each point checked.
859 7.17.2.3 Conspicuously note on the instrument the date of calibration.
860 7.17.32 TheA licensee shallmay not use survey instruments if the difference between the indicated 861 exposure rate and the calculated exposure rate is greatermore than 20 percent.
862 7.17.43 TheA licensee shall retain a record of each survey instrument calibration required by 7.17 for 3 863 years. The record shall include the:
864 7.17.43.1 Model and serial number of the instrument; 865 7.17.43.2 Date of the calibration; 866 7.17.43.3 Results of the calibration; and 867 7.17.43.4 Name of the individual who performed the calibration.
868 7.18 Determination of Dosages of Radioactive Material for Medical Use.Determination of dosages of 869 unsealed radioactive material for medical use.
870 7.18.1 A licensee shall determine and record the activity of each dosage prior tobefore medical use.
871 7.18.1.1 For photon-emitting radioactive material, this determination shall be within 30 872 minutes prior to medical use.
873 7.18.1.2 For all other radioactive material, this determination shall be within the period 874 before medical use that is no greater than 10 percent of the physical half-life of 875 the radioactive material.
876 7.18.2 For a unit dosage, the determination required by 7.18.1 shall be made by:
877 7.18.2.1 dDirect measurement of radioactivity; or 878 7.18.2.2 aA decay correction, based on the measurement made by:
879 (1) aA manufacturer or preparer licensed pursuant to Part 3 of these regulations or 880 equivalent provisions of another Agreement State, or NRC; or 881 (2) anAn NRC or Agreement State licensee for use in research in accordance with a 882 Radioactive Drug Research Committee-approved protocol or an Investigational 883 New Drug (IND) protocol accepted by FDA.
884 (3)
A PET radioactive drug producer licensed under Part 3, Section 3.8.10 or 885 equivalent NRC or Agreement State requirements.
886 7.18.3 For other than a unit dosages, the determination by 7.18.1 shall be made by:
887 7.18.3.1 dDirect measurement of radioactivity; or 888 7.18.3.2 by a cCombination of measurements of radioactivity and mathematical 889 calculations; or 890 7.18.3.3 by a cCombination of volumetric measurements and mathematical calculations, 891 based on the measurement made by:
892 Commented [JSJ91]: The requirement in 7.17.2.3 is replaced by 7.17.1.3 (above).
Commented [JSJ92]: Added, consistent with the requirements of 10 CFR 35.63(b)(2)(iii). This provision has been in federal rule for a number of years, but was omitted during prior rule amendments.
NRC Compatibility H&S Document 1 HRG Page 52 of 138
(1) aA manufacturer or preparer licensed pursuant to Part 3 of these regulations or 893 equivalent provisions of another Agreement State, or NRC.
894 (2)
A PET radioactive drug producer licensed under Part 3, Section 3.8.10 or 895 equivalent NRC or Agreement State requirements.
896 7.18.4 Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage 897 differs from the prescribed dosage by more than 20 percent.
898 7.18.5 A license shall retain a record of the each dosage determination required by 7.18.1 for 3 years.
899 The record shall contain the:
900 7.18.5.1 Name of the radioactive drug; 901 7.18.5.2 Patient's or human research subjects name, and identification number if one has 902 been assigned; 903 7.18.3.35.3 Prescribed dosage; 904 7.18.3.45.4 Determined dosage; or a notation that the total activity is less than 1.1 MBq (30 905
µCi);
906 7.18.3.55.5 Date and time of the dosage determination; and 907 7.18.3.65.6 Name of the individual who determined the dosage.
908 7.19 Authorization for Calibration, Transmission and Reference Sources.Authorization for 909 calibration, transmission and reference sources.
910 7.19.1 Any person authorized by 7.3 for medical use of radioactive material may receive, possess, and 911 use any of the following radioactive material for check, calibration, transmission and reference 912 use:
913 7.19.17.19.1.1 Sealed sources manufactured and distributed by persons specifically licensed 914 pursuant to Part 3 of these regulations or equivalent provisions of the another 915 Agreement State, a Licensing State, or NRC, and that do not exceed 1.1 GBq 916 (30 mCi) each;Sealed sources, not exceeding 1.11 GBq (30 mCi) each, 917 manufactured and distributed by a person licensed under Part 3, by NRC 918 under 10 CFR 32.74 or equivalent Agreement State regulations; 919 7.19.1.2 Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a 920 licensee authorized to redistribute the sealed sources manufactured and 921 distributed by a person licensed under Part 3, by NRC under 10 CFR 32.74 922 or equivalent Agreement State regulations, providing the redistributed 923 sealed sources are in the original packaging and shielding and are 924 accompanied by the manufacturers approved instructions; 925 7.19.27.19.1.3 Any radioactive material with a half-life not longer than 120 days or less in 926 individual amounts not to exceed 0.550.56 GBq (15 mCi);
927 7.19.37.19.1.4 Any radioactive material with a half life greaterlonger than 120 days in individual 928 amounts not to exceed the smaller of 7.4 MBq (200 uCi) or 1000 times the 929 quantities in Part 3 Schedule 3B:; or 930 7.19.3.1 7.4 MBq (200 µCi);
931 7.19.3.2 1000 times the quantities in Part 3 Schedule 3B; and 932 Commented [JSJ93]: Added, consistent with the requirements of 10 CFR 35.63(c)(3)(ii). This provision has been in federal rule for a number of years, but was omitted during prior rule amendments.
NRC Compatibility H&S Commented [JJ94]:
Correction of numbering errors made in this section.
Commented [JSJ95]: Section 7.19 is revised for consistency with the 2018 amendments to 10 CFR 35.65.
NRC Compatibility D NRC RATS 2018-1 Commented [JSJ96]: This provision is not new to federal rule, but was previously omitted from Colorado rule.
NRC Compatibility D Document 1 HRG Page 53 of 138
7.19.47.19.1.5 Technetium-99m in amounts as needed.
933 7.19.2 Radioactive material in sealed sources authorized by this provision shall not be:
934 7.19.2.1 Used for medical use as defined in 7.2 except in accordance with the 935 requirements in 7.40; or 936 7.19.2.1 Combined (i.e., bundled or aggregated) to create an activity greater than 937 the maximum activity of any single sealed source authorized under 7.19.
938 7.19.3 A licensee using calibration, transmission, and reference sources in accordance with the 939 requirements in 7.19.1 or 7.19.2 need not list these sources on a specific medical use 940 license.
941 7.20 Requirements for Possession of Sealed Sources and Brachytherapy Sources.Requirements for 942 possession of sealed sources and brachytherapy sources.
943 7.20.1 A licensee in possession of any sealed source or brachytherapy source shall follow the radiation 944 safety and handling instructions supplied by the manufacturer or equivalent instructions approved 945 by the Department and shall maintain the instructions for the duration of source use in a legible 946 form convenient to users.
947 7.20.2 A licensee in possession of a sealed source shall test the source for leakage:
948 7.20.2.1 In accordance with Part 4 of these regulations; andTest the source for leakage 949 before its first use unless the licensee has a certificate from the supplier 950 indicating that the sources was tested within 6 months before transfer to 951 the licensee; and 952 7.20.2.2 Test the source for leakage Atat intervals not to exceed 6 months or at 953 intervals approved by the Department, another Agreement State, a Licensing 954 State or the NRC in the Sealed Source and Device Registry.
955 7.20.2.3 A licensee shall retain records of leak tests required by 7.20.2 for 3 years.
956 The records must include the model number, and serial number if one has 957 been assigned, of each source tested; the identity of each source by 958 radionuclide and its estimated activity; the results of the test; the date of 959 the test; and the name of the individual who performed the test.
960 7.20.3 To satisfy the leak test requirements of 7.20, the licensee shall measure the sample so that the 961 leak test can detect the presence of 185 Bq (0.005 uCi) of radioactive material in the sample.
962 7.20.4 If the leak test reveals the presence of 0.005 microcurie (185 Bq) or more of removable 963 contamination, the licensee shall:
964 7.20.4.1 Immediately withdraw the sealed source from use and store, dispose or cause it 965 to be repaired in accordance with the requirements of these regulations; and 966 7.20.4.2 File a written report with the Department within 5 days of receiving the leak test 967 result, including the model number and serial number, if assigned, of the leaking source, 968 the radionuclide and its estimated activity, the date and results of the test, and the action 969 taken.
970 7.20.5 A licensee in possession of a sealed source or brachytherapy source, except for a gamma 971 stereotactic radiosurgery source, shall conduct a semi-annual physical inventory of all such 972 sources. The licensee shall retain each inventory record for 3 years. The inventory records 973 shallmust contain the model number of each source, and serial number if one has been 974 Commented [JSJ97]: This is a new provision/requirement in federal rule, added for consistency with the 2018 amendments to 10 CFR Part 35.65(b).
The added language clarifies that while sources may be authorized under 7.19 (35.50) they may only be used for medical purposes under the requirements of 7.40 (35.500).
The NRC considers the exposure of humans/patients to a radioactive source to be medical use.
Compatibility D NRC RATS 2018-1 CROSS
REFERENCES:
7.2 = 10 CFR 35.2 7.40 = 10 CFR 35.500 Commented [JSJ98]: This is a new provision/requirement, added for consistency with the 2018 amendments to 10 CFR Part 35.65(c).
Compatibility D NRC RATS 2018-1 CROSS
REFERENCES:
7.19.1 = 10 CFR 35.65(a) 7.19.2 = 10 CFR 35.65(b)
Commented [JSJ99]: Rather than defer to Part 4, the requirements are incorporated into Part 7, consistent with the format of 10 CFR 35.67. These requirements are the same as those currently found in Part 4.
[Non-RATS item]
Commented [JSJ100]: This provision is added for clarity consistent with 10 CFR 35.67(d).
The provision in Part 4 pertaining to recordkeeping for leak test is not specific with regard to the leak testing record. The proposed language adds clarity to the recordkeepoing (and similar to the existing requirement for source inventory in 7.20.5).
The proposed change also provides some regulatory relief by reducing the duration that leak test records must be maintained - from 5 years to 3 years.
[Non-RATS item]
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assigned, the identity of each source by radionuclide and its estimated activity, the location of 975 each source, and the name of the individual who performed the inventory.
976 7.21 Reports and Notifications of Misadministrations.Report and notification of a medical event.
977 7.21.1 Other than events that result from intervention by a patient or human research subject, a licensee 978 shall report any event in which the administration of radioactive material or radiation from 979 radioactive material results in:A licensee shall report any event as a medical event, except 980 for an event that results from patient or human research subject intervention, in which:
981 7.21.1.1 The administration of radioactive material or radiation from radioactive 982 material, except permanent implant brachytherapy, results in:
983 7.21.1.1 (1)
A dose that differs from the prescribed dose or dose that would have 984 resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective 985 dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) 986 shallow dose equivalent to the skin; and either 987 (1)
(a)
The total dose delivered differs from the prescribed dose by 20 percent 988 or more; 989 (2)
(b)
The total dosage delivered differs from the prescribed dosage by 20 990 percent or more or falls outside the prescribed dosage range; or 991 (3)
(c)
The fractionated dose delivered differs from the prescribed dose, for a 992 single fraction, by 50 percent or more.
993 7.21.1.2 (2)
A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv 994 (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the 995 skin from any of the following:
996 (1)
(a)
An administration of a wrong radioactive drug containing 997 radioactive material or the wrong radionuclide for a brachytherapy 998 procedure; 999 (2)
(b)
An administration of a radioactive drug containing radioactive 1000 material by the wrong route of administration; 1001 (3)
(c)
An administration of a dose or dosage to the wrong individual or 1002 human research subject; 1003 (4)
(d)
An administration of a dose or dosage delivered by the wrong 1004 mode of treatment; or 1005 (5)
(e)
A leaking sealed source.
1006 7.21.1.3 (3)
A dose to the skin or an organ or tissue other than the treatment site that 1007 exceeds by:
1008 (a) 0.5 Sievert (50 rem) to an organ or tissue and0.5 Sievert (50 1009 rem) or more the expected dose to that site from the procedure if 1010 the administration had been given in accordance with the written 1011 directive prepared or revised before administration; and 1012 (b) 50 percent of the dose expected from the administration defined 1013 in the written directive (excluding, for permanent implants, seeds that 1014 were implanted in the correct site but migrated outside the treatment 1015 Commented [JJ101]: Consistent with current NRC language in 10 CFR 35, Part 7 is being modified to change the term misadministration to medical event.
Commented [JJ102]: Reworded for consistency with 10 CFR 35.3045.
Due to the change in certain requirements related to permanent implant brachytherapy, the requirements pertaining to medical events for these materials are modified in 7.21.
NRC Compatibility C NRC RATS 2018-1 Commented [JSJ103]: Language pertaining to human research subject intervention is retained from the current rule although it is not found in 10 CFR 35.
Commented [JSJ104]: 35.3045(a)(1)(ii)(A)
NRC Compatibility C Document 1 HRG Page 55 of 138
site).50 percent or more the expected dose to that site from the 1016 procedure if the administration had been given in accordance with 1017 the written directive prepared or revised before administration.
1018 7.21.1.2 For permanent implant brachytherapy, the administration of radioactive 1019 material or radiation from radioactive material (excluding sources that were 1020 implanted in the correct site but migrated outside the treatment site) that 1021 results in:
1022 (1)
The total source strength administered differing by 20 % or more 1023 from the total source strength documented in the post-implantation 1024 portion of the written directive; 1025 (2)
The total source strength administered outside of the treatment site 1026 exceeding 20 % of the total source strength documented in the 1027 post-implantation portion of the written directive; or 1028 (3)
An administration that includes any of the following:
1029 1030 (a)
The wrong radionuclide; 1031 1032 (b)
The wrong individual or human research subject; 1033 1034 (c)
Sealed source(s) implanted directly into a location 1035 discontiguous from the treatment site, as documented in the 1036 post-implantation portion of the written directive; or 1037 1038 (d)
A leaking sealed source resulting in a dose that exceeds 0.5 1039 Sv (50 rem) to an organ or tissue.
1040 7.21.2 A licensee shall report any event resulting from intervention of a patient or human research 1041 subject in which the administration of radioactive material or radiation from radioactive material 1042 results, or will result in, unintended permanent functional damage to an organ or a physiological 1043 system, as determined by a physician.
1044 7.21.3 The licensee shall notify the Agency by telephone the Department no later than the next 1045 calendar day after discovery of the misadministrationmedical event.
1046 7.21.4 The licensee shall submit a written report to the AgencyDepartment within 15 days after 1047 discovery of the misadministrationmedical event.
1048 7.21.4.1 The written report must include:
1049 (1)
The licensee's name; 1050 (2)
The name of the prescribing physician; 1051 (3)
A brief description of the event; 1052 (4)
Why the event occurred; 1053 (5)
The effect, if any, on the individual(s) who received the administration; 1054 (6)
What actionsActions, if any, that have been taken, or are planned, to prevent 1055 recurrence; and 1056 Commented [JSJ105]: This is a new requirement added consistent with the 2018 amendments to 10 CFR 35.3045(a)(2) pertaining to permanent implant brachytherapy.
NRC RATS 2018-1 NRC Compatibility C Document 1 HRG Page 56 of 138
(7)
Certification that the licensee notified the individual (or the individual's 1057 responsible relative or guardian), and if not, why not.
1058 7.21.4.2 The report may not contain the individual's name or any other information that 1059 could lead to identification of the individual.
1060 7.21.5 The licensee shall provide notification of the misadministrationmedical event to the referring 1061 physician and also notify the individual who is the subject of the misadministrationmedical event 1062 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 discovery, unless the referring physician personally informs the 1063 licensee either that he or she will inform the individual or that, based on medical judgment, telling 1064 the individual would be harmful. The licensee is not required to notify the individual without first 1065 consulting the referring physician. If the referring physician or the affected individual cannot be 1066 reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall notify the individual as soon as possible thereafter.
1067 The licensee may not delay any appropriate medical care for the individual, including any 1068 necessary remedial care as a result of the misadministrationmedical event, because of any 1069 delay in notification. To meet the requirements of this paragraph7.21.5, the notification of the 1070 individual who is the subject of the misadministrationmedical event may be made instead to that 1071 individual's responsible relative or guardian. If a verbal notification is made, the licensee shall 1072 inform the individual, or appropriate responsible relative or guardian, that a written description of 1073 the event can be obtained from the licensee upon request. The licensee shall provide such a 1074 written description if requested.
1075 7.21.6 Aside from the notification requirement, nothing in this section affects any rights or duties of 1076 licensees and physicians in relation to each other, to individuals affected by the 1077 misadministrationmedical event, or to that individual's responsible relatives or guardians.
1078 7.21.7 A licensee shall retain a record of a misadministration for 3 years. The record must contain:
1079 7.21.7.1 The licensee's name; 1080 7.21.7.1 Names of the individuals involved; 1081 7.21.7.1 The social security number or other identification number if one has been 1082 assigned, of the individual who is the subject of the misadministration; 1083 7.21.7.1 A brief description of the event and why it occurred; 1084 7.21.7.1 The effect, if any, on the individual; 1085 7.21.7.1 The actions, if any, taken, or planned, to prevent recurrence; and 1086 7.21.7.1 Whether the licensee notified the individual (or the individual's responsible 1087 relative or guardian) and, if not, whether such failure to notify was based on guidance 1088 from the referring physician.
1089 7.21.7 A licensee shall:
1090 7.21.7.1 Annotate a copy of the report provided to the Department with the:
1091 (1)
Name of the individual who is the subject of the event; and 1092 (2)
Identification number or if no other identification number is available, the 1093 social security number of the individual who is the subject of the event; 1094 and 1095 7.21.7.2 Provide a copy of the annotated report to the referring physician, if other 1096 than the licensee, no later than 15 days after the discovery of the event.
1097 Commented [JSJ106]: This provision is replaced by the revised requirements in new 7.21.7 (below).
Commented [JSJ107]: In part, this provision replaces some requirements of the prior 7.21.7, consistent with 10 CFR 35.3045(g).
Commented [JSJ108]: This provision is rephrased to conform to an NRC (federal) rulemaking that is currently in process for 10 CFR 35.3045. The federal rulemaking is intended to provide protection of social security information by limiting its use in regulatory documents where possible.
Proposing this change now is expected to help eliminate the need for a future rulemaking.
Refer to FR 85 33527 for additional information.
Document 1 HRG Page 57 of 138
7.21.8 A copy of the record required under 7.21.7 shall be provided to the referring physician if other 1098 than the licensee, within 15 days after discovery of the misadministration.
1099 7.22 Notification to the Department of Deceased Patients or Human Research Subjects Containing 1100 Radioactive Material.Notification to the Department of deceased patients or human research 1101 subjects containing radioactive material.
1102 7.22.1 The licensee shall notify the Department by telephone immediately upon discovery that a patient 1103 or human research subject containing radioactive material has died, and it is possible that any 1104 individual could receive exposures in excess of Part 4, section 4.14 as a result of the deceased's 1105 body.
1106 7.22.2 The licensee shall submit a written report to the Department within 30 days after discovery that 1107 the patient or human research subject referenced in 7.22.1 has died. The written report must 1108 include the:
1109 7.22.2.1 Licensee's name; 1110 7.22.2.2 Date of death; 1111 7.22.2.3 Radionuclide, chemical and physical form and calculated activity at time of death; 1112 and 1113 7.22.2.4 Names (or titles) and address(es) of known individuals who might have received 1114 exposures exceeding 5 mSv (500 mrem).
1115 7.22.3 The licensee shall retain a record of each written report required by 7.22 for 3 years.
1116 7.23 Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child.Report and 1117 notification of a dose to an embryo/fetus or a nursing child 1118 7.23.1 A licensee shall report any dose to an embryo/fetus that is greater than 5 mSv (500 mrem) dose 1119 equivalent that is a result of an administration of radioactive material or radiation from radioactive 1120 material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, 1121 in advance, by the authorized user.
1122 7.23.2 A licensee shall report any dose to a nursing child, that was not specifically approved, in advance, 1123 by the authorized user, that is a result of an administration of radioactive material to a breast 1124 feeding individual that:
1125 7.23.2.1 Is greater than 5 millisievert (500 mrem) total effective dose equivalent; or 1126 7.23.2.2 Has resulted in unintended permanent functional damage to an organ or a 1127 physiological system of the child, as determined by a physician.
1128 7.23.3 The licensee shall notify by telephone the AgencyDepartment no later than the next calendar day 1129 after discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 1130 7.23.2.
1131 7.23.4 The licensee shall submit a written report to the AgencyDepartment within 15 days after 1132 discovery of a dose to the embryo/fetus or nursing child that requires a report in 7.23.1 or 7.23.2.
1133 7.23.4.1 The written report must include:
1134 (1)
The licensee's name; 1135 (2)
The name of the prescribing physician; 1136 Commented [JSJ109]: This provision is replaced by new 7.21.7.2.
Document 1 HRG Page 58 of 138
(3)
A brief description of the event; 1137 (4)
Why the event occurred; 1138 (5)
The effect on the embryo/fetus or the nursing child; 1139 (6)
What actions, if any, have been taken, or are planned, to prevent recurrence; and 1140 (7)
Certification that the licensee notified the pregnant individual or mother (or the 1141 mother's or child's responsible relative or guardian), and if not, why not.
1142 7.23.4.2 The report must not contain the individual's or child's name or any other 1143 information that could lead to identification of the individual or child.
1144 7.23.5 The licensee shall notifyprovide notification of the event to the referring physician and also 1145 notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 1146 hours0.0133 days <br />0.318 hours <br />0.00189 weeks <br />4.36053e-4 months <br /> after discovery of an event that would require reporting under 7.23.1 or 7.23.2, unless the 1147 referring physician personally informs the licensee either that he or she will inform the mother or 1148 that, based on medical judgment, telling the mother would be harmful. The licensee is not 1149 required to notify the mother without first consulting with the referring physician. If the referring 1150 physician or mother cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, the licensee shall make the appropriate 1151 notifications as soon as possible thereafter. The licensee may not delay any appropriate medical 1152 care for the embryo/fetus or for the nursing child, including any necessary remedial care as a 1153 result of the event, because of any delay in notification. To meet the requirements of this 1154 paragraph7.23.5, the notification may be made to the mother's or child's responsible relative or 1155 guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee 1156 shall inform the mother, or the mother's or child's responsible relative or guardian, that a written 1157 description of the event can be obtained from the licensee upon request. The licensee shall 1158 provide such a written description if requested.
1159 7.23.6 A licensee shall: retain a record of a dose to an embryo/fetus or a nursing child for 3 years. The 1160 record must contain:
1161 7.23.6.1 The licensee's name; 1162 7.23.6.2 Names of all the individuals involved; 1163 7.23.6.3 Social security number or other identification number if one has been assigned to 1164 the pregnant individual or nursing child who is the subject of the event; 1165 7.23.6.4 A brief description of the event and why it occurred; 1166 7.23.6.5 The effect, if any, on the embryo/fetus or nursing child; 1167 7.23.6.6 The actions, if any, taken, or planned, to prevent recurrence; and 1168 7.23.6.7 Whether the licensee notified the pregnant individual or mother (or the mother's 1169 or child's responsible relative or guardian) and, if not, whether such failure to 1170 notify was based on guidance from the referring physician.
1171 7.23.6.1 Annotate a copy of the report provided to the Department with the:
1172 (1)
Name of the pregnant individual or the nursing child who is the 1173 subject of the event; and 1174 Commented [JSJ110]: This provision replaces 7.23.6.1 through 7.23.6.7, consistent with the approach and format used in 10 CFR Part 35.3047, and to parallel the changes to 7.21.7.
Current provision 7.23.4 provides requirements for the contents of the specified report, which is largely repeated in the prior language of 7.23.6 that is proposed for deletion. The proposed change to 7.23.6 streamlines the process by requiring the licensee to annotate the existing required report with the specified information.
Proposing this change now is expected to help eliminate the need for a future rulemaking.
Document 1 HRG Page 59 of 138
(2)
Identification number or if no other identification number is 1175 available, the social security number of the individual who is the 1176 subject of the event.
1177 7.23.7 A copy of the record required under 7.23.6 shall be provided to the referring physician, if other 1178 than the licensee, within 15 days after discovery of the event.
1179 7.24 Vial Shields and Labels.Labeling of vials and syringes.
1180 7.24.1 A licensee shall require each individual preparing or handling a vial that contains a 1181 radiopharmaceutical to keep the vial in a vial radiation shield.
1182 7.24.2 Each syringe and vial that contains a radioactive drug shall be labeled to identify the radioactive 1183 drug, to include the isotope and amount of radioactivity. Each syringe shield and vial shield shall 1184 also be labeled unless the label on the syringe or vial is visible when shielded.
1185 7.25 Surveys for Contamination and Ambient Exposure Rate.Surveys for contamination and 1186 ambient exposure rate.
1187 7.25.1 Surveys required by 7.25.2 and 7.25.3 are in addition to surveys required by Part 4.
1188 7.25.2 Daily Survey Requirements 1189 7.25.2.1 At the end of each day of use, a licensee shall survey with an exposure rate 1190 instrument, all areas where radioactive drugs containing radioactive material 1191 requiring a written directive were prepared for use or administered.
1192 (1)
A licensee does not need to perform the surveys required by 7.25.2.1 in an area 1193 where patients or human research subjects are confined when they cannot be 1194 released pursuant to 7.26.
1195 7.25.2.2 At the end of each day of use, a licensee shall survey for removable 1196 contamination all areas where generators and bulk radioactive drugs are 1197 prepared for use. An instrument capable of detecting 33.3 becquerels (2000 1198 dpm) of contamination on each wipe sample shall be used.
1199 7.25.3 Weekly Survey Requirements 1200 7.25.3.1 At least once each week, a licensee shall survey, with an exposure rate 1201 instrument, all areas where radioactive drugs or radioactive wastes are stored.
1202 7.25.3.2 At least once each week, a licensee shall survey for removable contamination in 1203 all areas where radioactive materials other than sealed sources as defined in 1204 Part 7 are stored. An instrument capable of detecting 33.3 becquerels (2000 1205 dpm) of contamination on each wipe sample shall be used.
1206 7.25.4 A licensee shall establish action levels for the surveys required by 7.25.2 and 7.25.3 and shall 1207 require that the individual performing the survey immediately notify the Radiation Safety Officer if 1208 action levels are exceeded.
1209 7.25.5 A licensee shall retain a record of each survey required by 7.25.1, 7.25.2 and 7.25.3 for 3 years.
1210 The record must include:
1211 7.25.5.1 The date of the survey; 1212 7.25.5.2 The results of the survey; 1213 Commented [JSJ111]: This provision is rephrased to conform to an NRC (federal) rulemaking that is currently in process for 10 CFR Part 35.3047. The federal rulemaking is intended to provide protection of social security information by limiting its use in regulatory documents where possible.
Refer to FR 85 33527 for additional information.
Document 1 HRG Page 60 of 138
7.25.5.3 The instrument used to make the survey (including, if applicable, that the 1214 instrument was checked for consistent response with a dedicated check source 1215 prior to each daily use); and 1216 7.25.5.4 The name of the individual who performed the survey.
1217 7.26 Release of Individuals Containing Radioactive Drugs or Implants.Release of individuals 1218 containing unsealed radioactive material or implants containing radioactive material.
1219 7.26.1 A licensee may authorize the release from the licensees control of any individual who has been 1220 administered radioactive drugs or permanent implants containing radioactive material if the total 1221 effective dose equivalent to any other individual from exposure to the released individual is not 1222 likely to exceed 5 mSv (0.5 rem).1 1223 1 Appendix U of U.S. Nuclear Regulatory Commission NUREG-1556, Vol. 9, Consolidated Guidance 1224 About Materials Licenses: Program Specific Guidance About Medical Licenses describes methods for 1225 calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 1226 5 mSv (0.5 rem).
1227 7.26.2 A licensee shall provide the released individual or the individuals parent or guardian with 1228 instructions, including written instructions on the actions recommended to maintain doses to other 1229 individuals as low as is reasonably achievable if the total effective dose equivalent to any other 1230 individual is likely to exceed 1 mSv (0.1 rem).
1231 7.26.2.1 If the total effective dose equivalent to a nursing infant or child could exceed 1 1232 mSv (0.1 rem) assuming there were no interruption in breast-feeding, the 1233 instructions shall also include:
1234 (1)
Guidance on the interruption or discontinuation of breast-feeding; and 1235 (2)
Information on the potential consequences, if any, of failure to follow the 1236 guidance.
1237 7.26.3 If the total effective dose equivalent to a nursing infant or child could exceed 5 mSv (0.5 rem) 1238 from continued breast-feeding, the licensee shall maintain a record that the instructions required 1239 by 7.26.2 were provided to a breast-feeding woman.
1240 7.26.4 The licensee shall maintain a record of the basis for authorizing the release of an individual in 1241 accordance with 7.26, if the total effective dose equivalent is calculated by:
1242 7.26.4.1 Using the retained activity rather than the administered activity; 1243 7.26.4.2 Using an occupancy factor less than 0.25 at 1 meter; 1244 7.26.4.3 Using the biological or effective half-live; and 1245 7.26.4.4 Considering the shielding by tissue.
1246 7.26.5 The records required by 7.26.3 and 7.26.4 must be retained for 3 years after the date of release 1247 of the individual.
1248 7.26.6 Reports of Patient Departure Prior to Authorized Release.
1249 7.26.6.1 The licensee shall notify the Department by telephone immediately upon 1250 discovery that a patient or human research subject has departed from the 1251 licensee's facility without authorization under 7.26.
1252 Document 1 HRG Page 61 of 138
7.26.6.2 The licensee shall submit a written report to the Department within 30 days after 1253 discovery of the unauthorized departure. The written report must include:
1254 (1)
The licensee's name; 1255 (2)
The date and time of the unauthorized departure; 1256 (3)
The projected date and time when release would have occurred; 1257 (4)
The address of the patient's or human research subject's home or anticipated 1258 destination following departure; 1259 (5)
The radionuclide, chemical and physical form and calculated activity at time of 1260 release; 1261 (6)
The apparent reason(s) for the departure prior to authorized release; and 1262 (7)
A description of any changes in the licensee's patient release criteria or patient 1263 instructions that are designed to avoid a recurrence of such an event.
1264 7.27 Mobile Nuclear Medicine Service Technical Requirements.Mobile nuclear medicine service 1265 technical requirements.
1266 A licensee providing mobile nuclear medicine service shall:
1267 7.27.1 Transport to each clients address of use only syringes or vials containing prepared drugs or 1268 radioactive materials that are intended for reconstitution of radioactive drug kits; 1269 7.27.2 Bring into each clients address of use all radioactive material to be used and, before leaving, 1270 remove all unused radioactive material and associated radioactive waste; 1271 7.27.3 Secure or keep under constant surveillance and immediate control all radioactive material when 1272 in transit or at a clients address of use; 1273 7.27.4 Check instruments used to measure the activity of unsealed radioactive material for proper 1274 function before medical use at each client's address or on each day of use, whichever is more 1275 frequent. At a minimum, the check for proper function shall include a constancy check; 1276 7.27.5 Check survey instruments for consistent response with a dedicated check source before use at 1277 each client's address; 1278 7.27.6 Prior to leaving a clients address of use, perform area surveys and survey for removable 1279 contamination in all areas of use, to ensure compliance with Part 4 of these regulations; and 1280 7.27.7 Retain a record of each survey required by 7.27.6 for 3 years. The record must include the date 1281 of the survey, the results of the survey, the instrument used to make the survey, and the name of 1282 the individual who performed the survey.
1283 7.28 Storage of Volatiles and Gases.
1284 7.28.1 A licensee shall store volatile radioactive materials and radioactive gases in a radiation shield and 1285 container.
1286 7.28.2 A licensee shall store and use a multi-dose container in a properly functioning fume hood.
1287 7.28.3 A licensee who administers radioactive aerosols or gases shall do so with a system that will keep 1288 airborne concentrations within the limits prescribed in Part 4 of these regulations.
1289 Document 1 HRG Page 62 of 138
7.28.3.1 The system shall either be directly vented to the atmosphere through an air 1290 exhaust or provide for collection and decay or disposal of the aerosol or gas in a 1291 shielded container.
1292 7.28.3.2 A licensee shall check the operation of collection systems monthly. Records of 1293 these checks shall be maintained for 3 years.
1294 7.29 Decay-In-Storage.Decay-in-storage.
1295 7.29.1 A licensee may hold radioactive material with a physical half-life of less than or equal to 120 days 1296 for decay-in-storage before disposal without regard forto its radioactivity if the licenseeit:
1297 7.29.1.1 Monitors radioactive material at the container surface before disposal and 1298 determines that its radioactivity cannot be distinguished from the background 1299 radiation level with aan appropriate radiation detection survey instrumentmeter 1300 set on its most sensitive scale and with no interposed shielding; and 1301 7.29.1.32 Removes or obliterates all radiation labels, except for radiation labels on 1302 materials that are within containers and that will be handledmanaged as 1303 biomedical waste after they have been released from the licensee; and 1304 7.29.1.4 Separates and monitors each generator column individually with all radiation 1305 shielding removed to ensure that its contents have decayed to background 1306 radiation level before disposal.
1307 7.29.2 Records of Decay-in-Storage.
1308 For radioactive material disposed in accordance with 7.29.1, the licensee shall retain a record of 1309 each disposal for 3 years.A licensee shall retain a record of each disposal permitted under 1310 7.29.1 as follows:
1311 7.29.2.1 A licensee shall maintain records of the disposal of licensed materials, as 1312 required by 7.29, for 3 years. The record must include the date of the disposal, 1313 the survey instrument used, the background radiation level, the radiation level 1314 measured at the surface of each waste container, and the name of the individual 1315 who performed the survey.
1316 SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, 1317 AND EXCRETION STUDIES 1318 Section D - Unsealed Radioactive Material - Written Directive Not Required 1319 7.30 Use of Unsealed Radioactive Material for Uptake, Dilution, and Excretion Studies for which a 1320 Written Directive is Not Required.Use of unsealed radioactive material for uptake, dilution, 1321 and excretion studies for which a written directive is not required.
1322 7.30.1 A licensee may use any unsealed radioactive material, in quantities that do not require a written 1323 directive, as described in 7.11, for a diagnostic use involving measurements of uptake, dilution, or 1324 excretion that:Except for quantities that require a written directive under 7.11.2, a licensee 1325 may use any unsealed radioactive material prepared for medical use for uptake, dilution, 1326 or excretion studies that is:
1327 7.30.1.1 Is obtained fromObtained from:
1328 (1) aA manufacturer or preparer licensed pursuant tounder Part 3, Section 1329 3.12.10 or equivalent regulations of another Agreement State, a 1330 Licensing State, or NRC; or; 1331 Commented [JSJ112]: Wording and formatting/alignment modifications were made for consistency with 10 CFR 35.92.
Commented [JSJ113]:
This provision combines the requirements found in 10 CFR 35.92(b) and 10 CFR 35.2092.
The CFR (Part 35) structure retains recordkeeping requirements in one area of the rule, while in Part 7, the recordkeeping requirements are generally retained with the requirement that drives the record.
The proposed language does not change the requirement found in current rule.
Commented [JSJ114]: Modified format to sentence case for consistency with 10 CFR Part 35.
Commented [JSJ115]: Language updated for consistency with the flow and format of 10 CFR 35.100.
[Non-NRC RATS 2018-1 items]
CROSS REFERENCES USED IN THIS SECTION:
7.11.2 = 10 CFR 35.40(b) 3.8.10 = 10 CFR 30.32(j)
Document 1 HRG Page 63 of 138
(2)
A PET radioactive drug producer licensed under Part 3, Section 1332 3.8.10 or equivalent regulations of an Agreement State or NRC; or 1333 7.30.1.2 Excluding production of PET radioactive material, is prepared by an authorized 1334 nuclear pharmacist, a physician who is an authorized user and who meets the 1335 requirements specified in Appendix 7E, Appendix 7F, or Appendix 7E3.1(2)(g), or 1336 an individual under the supervision of either as specified in 7.10; 1337 7.30.1.2 Excluding production of PET radionuclides, prepared by:
1338 (1)
An authorized nuclear pharmacist; 1339 (2)
A physician who is an authorized user and who meets the 1340 requirements specified in Appendix 7E, or Appendix 7F and Section 1341 7E3.1(2)(g) of Appendix 7E; or 1342 (3)
An individual under the supervision, as specified in 7.10, of the 1343 authorized nuclear pharmacist in 7.30.1.2(1) or the physician who is 1344 an authorized user in 7.30.1.2(2); or 1345 1346 7.30.1.3 Is oObtained from and prepared by a Department, Agreement State, Licensing 1347 State or NRC licensee for use in research in accordance with a Radioactive Drug 1348 Research Committee-approved protocol or an Investigational New Drug (IND) 1349 protocol accepted by FDA; or 1350 7.30.1.4 Is pPrepared by the licensee for use in research in accordance with a 1351 Radioactive Drug Research Committee-approved application or an 1352 Investigational New Drug (IND) protocol accepted by FDA for use in research.
1353 7.30.2 Authorized User Training For Uptake, Dilution, And Excretion Studies.
1354 The licensee shall require an authorized user of an unsealed radioactive material for the uses 1355 authorized under 7.30 to meet the requirements of Appendix 7D.
1356 7.31 Possession of Survey Instrument.Reserved 1357 A licensee authorized to use radioactive material for uptake, dilution, and excretion studies shall 1358 possess a portable radiation detection survey instrument capable of detecting dose rates over the 1359 range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour. The instrument shall be 1360 operable and calibrated in accordance with 7.17.
1361 SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN 1362 DIRECTIVE NOT REQUIRED 1363 7.32 Use of Unsealed Radioactive Material for Imaging and Localization Studies for which a Written 1364 Directive is Not Required.Use of unsealed radioactive material for imaging and localizations 1365 studies for which a written directive is not required.
1366 Except for quantities that require a written directive under 7.11, a licensee may use any unsealed 1367 radioactive material prepared for medical use for imaging and localization studies that is:
1368 7.32.1 A licensee may use, for imaging and localization studies, any radioactive material prepared for 1369 medical use, in quantities that do not require a written directive, as described in 7.11, that:
1370 7.32.1 Obtained from:
1371 Commented [JSJ116]:
CROSS
REFERENCES:
Appendix 7E = 10 CFR 35.290 Appendix 7F = 10 CFR 35.390 Section 7E3.1(2)(g) of App 7E = 35.290(c)(1)(ii)(G) 7.10 = 10 CFR 35.27 Commented [JSJ117]: This requirement does not appear in 10 CFR Part 35. The requirement originated from G.45 in SSR Part G (2003) and is believed to be unnecessary.
Commented [JSJ118]:
Section 7.32 is modified for consistency with the format and content of 10 CFR 35.200.
CROSS REFERENCES IN THIS SECTION:
7.11 = 10 CFR 35.40(b) 3.8.10 = 10 CFR 30.32(j)
Document 1 HRG Page 64 of 138
7.32.1.1 Is obtained from a A manufacturer or preparer licensed pursuant to Part 3, 1372 Section 3.12.10 or equivalent regulations of another Agreement State, a 1373 Licensing State, or NRC; or; 1374 7.32.1.2 A PET radioactive drug producer licensed under Part 3, Section 3.8.10; or 1375 7.32.1.2 Excluding production of PET radioactive material, is prepared by an authorized 1376 nuclear pharmacist, a physician who is an authorized user and who meets the 1377 requirements specified in Appendix 7E, or Appendix 7F and Appendix 7E3.1(2)(g), or an 1378 individual under the supervision of either as specified in 7.10.
1379 7.32.2 Excluding production of PET radionuclides, prepared by:
1380 7.32.2.1 An authorized nuclear pharmacist; 1381 7.32.2.2 A physician who is an authorized user and who meets the requirements 1382 specified in Appendix 7E, or Appendix 7F and 7E3.1(2)(g); or 1383 7.32.2.3 An individual under the supervision, as specified in 7.10, of the authorized 1384 nuclear pharmacist in 7.32.2.1 or the physician who is an authorized user in 1385 7.32.2.2; 1386 7.32.1.37.32.3 Is oObtained from and prepared by a Department, Agreement State, Licensing State or 1387 NRC licensee for use in research in accordance with a Radioactive Drug Research 1388 Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by 1389 FDA; or 1390 7.32.1.47.32.4 Is pPrepared by the licensee in accordance with a Radioactive Drug Research 1391 Committee-approved application or an Investigational New Drug (IND) protocol accepted 1392 by FDA for use in research.
1393 7.32.25 Authorized User Training for Imaging and Localization Studies for which a Written Directive is Not 1394 Required.
1395 The licensee shall require an authorized user of an unsealed radioactive material for the uses 1396 authorized under 7.32 to meet the requirements of Appendix 7E.
1397 7.33 Radionuclide Contaminants.Permissible molybdenum-99, strontium-82, and strontium-85 1398 concentrations.
1399 7.33.1 A licensee shallmay not administer to humans a radioactive drug containingthat contains:
1400 7.33.1.1 More than 0.15 kBq of molybdenum-99 per MBq of technetium-99m (0.15 µCi of 1401 99Mo per mCi of 99mTc).; or 1402 7.33.1.2 More than 0.02 kBq of strontium-82 per MBq of rubidium-82 chloride injection 1403 (0.02 µCi of 82Sr per mCi of 82Rb chloride); or more than 0.2 kBq of strontium-1404 85 per MBq of rubidium-82 chloride injection (0.2 µCi of 85Sr per mCi of 1405 82Rb).
1406 7.33.1.3 More than 0.2 kBq of strontium-85 per MBq of rubidium-82 chloride injection (0.2 1407
µCi of 85Sr per mCi of 82Rb).
1408 7.33.2 To demonstrate compliance with 7.33.1, the licensee preparing radioactive drugs from 1409 radionuclide generators shall measure the concentration of radionuclide contaminant in:
1410 7.33.2.1 Each eluate after receipt of a molybdenum-99/technetium-99m generator; 1411 Commented [JSJ119]: This provision is replaced with the reformatted requirements of 7.32.2 below.
Commented [JSJ120]:
CROSS REFERENCES IN THIS SECTION:
Appendix 7E = 10 CFR 35.290 Appendix 7F = 10 CFR 35.390 7E3.1(2)(g) = 10 CFR 35.290(c)(1)(ii)(G) 7.10 = 10 CFR 35.27 7.32.2.1 = paragraph (b)(1) of 10 CFR 35.200 7.32.2.2 = paragraph (b)(2) of 10 CFR 35.200 Commented [JSJ121]:
This provision is revised to follow the format of 10 CFR 35.204(a). This is a change in formatting only and does not change the current requirement.
Commented [JSJ122]: This provision is combined with 7.33.1.2 (above) consistent with the formatting of 10 CFR 35.204(a)(2).
Document 1 HRG Page 65 of 138
7.33.2.2 Each eluate or extract, before the first patient use of the day, as appropriate for 1412 other than molybdenum-99/technetium-99m generator systems.
1413 7.33.2 A licensee that uses molybdenum-99/technetium-99m generators for preparing a 1414 technetium-99m radioactive drug shall measure the molybdenum-99 concentration in each 1415 eluate from a generator to demonstrate compliance with 7.33.1.
1416 7.33.3 A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 1417 radioactive drug shall, before the first patient use of the day, measure the concentration of 1418 radionuclides strontium-82 and strontium-85 to demonstrate compliance with 7.33.1.
1419 7.33.3 Records of Radionuclide Purity.
1420 A licensee who must measure radionuclide contaminant concentration shall retain a record of 1421 each radionuclide contaminant test for 3 years. The record shall include, for each measured 1422 elution of radionuclide used to prepare a radioactive drug, the ratio of the measures expressed as 1423 kBq of contaminant per MBq of desired radionuclide (µCi/ mCi), the time and date of the test, and 1424 the name of the individual who made the measurement.
1425 1426 7.33.4 If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and 1427 strontium-85 concentrations, the licensee shall retain a record of each measurement as 1428 follows:
1429 1430 7.33.4.1 A licensee shall maintain a record of the molybdenum-99 concentration or 1431 strontium-82 and strontium-85 concentration tests required by 7.33.2 and 1432 7.33.3 for 3 years. The record must include:
1433 1434 (1)
For each measured elution of technetium-99m, the ratio of the measures 1435 expressed as kilobecquerel of molybdenum-99 per megabecquerel of 1436 technetium-99m (or microcuries of molybdenum per millicurie of 1437 technetium), the time and date of the measurement, and the name of the 1438 individual who made the measurement; or 1439 1440 (2)
For each measured elution of rubidium-82, the ratio of the measures 1441 expressed as kilobecquerel of strontium-82 per megabecquerel of 1442 rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium),
1443 kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or 1444 microcuries of strontium-85 per millicurie of rubidium), the time and date of 1445 the measurement, and the name of the individual who made the 1446 measurement.
1447 7.33.5 The licensee shall report any measurement that exceeds the limits in 7.33.1 at the time of 1448 generator elution, as follows:
1449 Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, 1450 and strontium-85 concentrations.
1451 7.33.5.1 The licensee shall notify by telephone the Department and the distributor of 1452 the generator within 7 calendar days after discovery that an eluate 1453 exceeded the permissible concentration listed in 7.33.1 at the time of 1454 generator elution. The telephone report to the Department must include the 1455 manufacturer, model number, and serial number (or lot number) of the 1456 generator; the results of the measurement; the date of the measurement; 1457 whether dosages were administered to patients or human research 1458 subjects, when the distributor was notified, and the action taken.
1459 7.33.5.2 The licensee shall submit a written report to the Department within 30 1460 calendar days after discovery of an eluate exceeding the permissible 1461 concentration at the time of generator elution. The written report must 1462 Commented [JSJ123]: Language is revised for consistency with 10 CFR 35.204(b).
The revised language does not effectively change the requirement from the current Part 7 requirement - only the wording is changed.
NRC Compatibility H&S NRC RATS 2018-1 Commented [JSJ124]: Revised language for consistency with 10 CFR 35.204(c).
NRC Compatibility H&S NRC RATS 2018-1 Commented [JSJ125]: This provision is replaced by 7.33.4.
Commented [JSJ126]: Recordkeeping requirement language is updated for consistency with the 2018 changes to 10 CFR 35.204(d) and 10 CFR 35.2204.
This provision replaces (prior) 7.33.3. The proposed requirements are similar to those found in 7.33.3 with slight variation in wording. The proposed wording is specific to the type of generator rather than the more generic language of the current provision.
NRC Compatibility H&S NRC RATS 2018-1 CROSS REFERENCES IN THIS SECTION:
7.33.2 = 10 CFR 35.204(b) 7.33.3 = 10 CFR 35.204(c)
Commented [JSJ127]: Reporting language is updated for consistency with the 2018 changes to 10 CFR 35.
This provision combines the requirements of 35.204(e) for reporting/notification of an eluate that exceeds the specified limits, and the associated recordkeeping requirements of 10 CFR 35.3204.
The proposed language provides some regulatory relief by specifying that the Department and distributor be notified by telephone within 7 days (rather than immediately) when a generator elution exceeds the specific criteria. The licensee must follow up within 30 days with a written report.
While Colorado rule has required notification to the Department (per prior 7.33.4) when generator contamination exceeds specific limits, federal rule prior to the 2018 amendment did not have such notification requirement.
NRC Compatibility H&S NRC RATS 2018-1 Document 1 HRG Page 66 of 138
include the action taken by the licensee; the patient dose assessment; the 1463 methodology used to make this dose assessment if the eluate was 1464 administered to patients or human research subjects; and the probable 1465 cause and an assessment of failure in the licensees equipment, 1466 procedures or training that contributed to the excessive readings if an error 1467 occurred in the licensees breakthrough determination; and the information 1468 in the telephone report as required by 7.33.5.1.
1469 7.33.4 Immediate Report.
1470 A licensee shall report immediately to the Department each occurrence of radionuclide 1471 contaminant concentration exceeding a limit specified in 7.33.1.
1472 7.34 Aerosols and Ggases.
1473 Provided the conditions of 7.28 are met, a licensee shall use radioactive aerosols or gases only if 1474 specific application is made to and approved by the Department.
1475 7.35 Radiation Detection Capability.Reserved 1476 A licensee authorized to use radioactive material pursuant to 7.32, 7.36, or 7.42 shall possess 1477 portable radiation detection survey instrumentation capable of detecting dose rates over the 1478 range 1.0 µSv (0.1 mrem) per hour to 500 µSv (50 mrem) per hour and over the range of 10 µSv 1479 (1 mrem) per hour to 10 mSv (1 rem) per hour. Each instrument shall be operable and calibrated 1480 in accordance with 7.17.
1481 SPECIFIC REQUIREMENTS FOR THE USE OF UNSEALED RADIOACTIVE MATERIAL - WRITTEN 1482 DIRECTIVE REQUIRED 1483 Section E - Unsealed Radioactive Material - Written Directive Required 1484 7.36 Use of Unsealed Radioactive Material for Which A Written Directive Is Required.Use of unsealed 1485 radioactive material for which a written directive is required.
1486 7.36.1 A licensee may use any unsealed radioactive material identified in 7F2.1(2)(f) prepared for 1487 diagnostic or therapeutic medical use and for which a written directive is required that is:
1488 7.36.1.1 Obtained from:
1489 7.36.1.1 (1)
Is obtained from a manufacturer or preparer licensed pursuant to 3.12.10 1490 or equivalent regulations of another Agreement State, a Licensing State, 1491 or NRC; orA manufacturer or preparer licensed under Part 3, Section 1492 3.12.10 or equivalent regulations of NRC or an Agreement State; or 1493 (2)
A PET radioactive drug producer licensed under Part 3, Section 1494 3.8.10 or equivalent Agreement State or NRC regulations; or 1495 7.36.1.2 Excluding production of PET radioactive material, is prepared by: an authorized 1496 nuclear pharmacist, a physician who is an authorized user and who meets the 1497 requirements specified in Appendix 7E, or Appendix 7F, or an individual under 1498 the supervision of either as specified in 7.10; 1499 (1)
An authorized nuclear pharmacist; 1500 (2)
A physician who is an authorized user and who meets the 1501 requirements specified in Appendix 7E, or Appendix 7F; or 1502 Commented [JSJ128]:
Provision is deleted as the general requirements of Part 4 apply. Licensees are required to possess instruments capable of performing measurements needed to demonstrate compliance with the license and regulations.
Commented [JSJ129]: Section header added for consistency with 10 CFR Part 35.
Commented [JSJ130]: Section has been reformatted for alignment and consistency with 10 CFR 35.300.
Introductory text in 7.36.1 revised for consistency with 2018 changes to 35.300 per NRC RATS 2018-1 (Compatibility B).
Other changes in 7.36.1 and 7.36.2 are not associated with NRC RATS 2018-1.
CROSS
REFERENCES:
7F2.1(2)(f) = 10 CFR 35.390(b)(1)(ii)(G) 3.8.10 = 10 CFR 35.32(j) 7.10 = 10 CFR 35.27 7.36.1.2(1) = 10 CFR 35.300(b)(1) 7.36.1.2(2) = 10 CFR 35.300(b)(2)
Commented [JSJ131]:
This is a change in formatting only - no requirements are changing.
Document 1 HRG Page 67 of 138
(3)
An individual under the supervision, as specified in 7.10, of the 1503 authorized nuclear pharmacist in 7.36.1.2(1) or the physician who is 1504 authorized under 7.36.1.2(2); or 1505 7.36.1.3 Is obtainedObtained from and prepared by a Department, Agreement State, 1506 Licensing State or NRC licensee for use in research in accordance witha 1507 Radioactive Drug Research Committee-approved protocol or an Investigational 1508 New Drug (IND) protocol accepted by FDA; or 1509 7.36.1.4 Is prepared by the licensee in accordance with a Radioactive Drug Research 1510 Committee-approved application or an Investigational New Drug (IND) protocol 1511 accepted by FDA for use in research.Prepared by the licensee for use in 1512 research in accordance with an Investigational New Drug (IND) protocol 1513 accepted by FDA.
1514 7.36.2 Authorized User Training For Use Of Any Unsealed Radioactive Material For Diagnostic Or 1515 Therapeutic Medical Use For Which A Written Directive Is Required.
1516 The licensee shall require an authorized user of an unsealed radioactive material for diagnostic or 1517 therapeutic medical use for which a written directive is required under 7.36 to meet the 1518 requirements of Appendix 7F.
1519 7.36.3 Authorized User Training For Oral Administration of < / = 1.22 GBq 131 I (33 mCi) Sodium Iodide 1520 Requiring A Written Directive.
1521 The licensee shall require an authorized user of an unsealed radioactive material for oral 1522 administration of < / = 1.22 GBq 131 I (33 mCi) sodium iodide requiring a written directive under 1523 7.36 to meet the requirements of Appendix 7G.
1524 7.36.4 Authorized User Training For Oral Administration Of > 1.22 GBq 131 I (33 mCi) Sodium Iodide 1525 Requiring A Written Directive.
1526 The licensee shall require an authorized user of an unsealed radioactive material for oral 1527 administration of > 1.22 GBq 131 I (33 mCi) sodium iodide requiring a written directive under 7.36 1528 to meet the requirements of Appendix 7H.
1529 7.36.5 Authorized User Training For Parenteral Administration Requiring A Written Directive.
1530 The licensee shall require an authorized user of an unsealed radioactive material for parenteral 1531 administration requiring a written directive under 7.36 to meet the requirements of Appendix 7I.
1532 7.37 Safety Iinstruction.
1533 In addition to the requirements of Part 10 of these regulations:
1534 7.37.1 TheA licensee shall provide radiation safety instruction, initially and at least annually, to 1535 personnel caring for patients or human research subjects that have received therapy with a 1536 radioactive drug, and who cannot be released in accordance with 7.26. To satisfy this 1537 requirement, the instruction must be commensurate with the duties of the personnel and 1538 include:
1539 7.37.2 The instruction required by 7.37.1 shall be appropriate for the duties of the personnel and include:
1540 7.37.21.1 Patient or human research subject control; 1541 7.37.21.2 Visitor control, to include the following;including:
1542 Commented [JSJ132]:
Consistent with federal rule in 10 CFR Part 35.300(c), the reference to the Radioactive Drug Research Committee is deleted.
Ref: NRC Letter 02/20/2020 Commented [JSJ133]: Section 7.37 is revised for consistency with the wording and formatting of 10 CFR 35.310.
These changes are not associated with RATS 2018-1.
NRC Compatibility H&S (7.37.1)
Commented [JSJ134]: This requirement is incorporated into 7.37.1.
Commented [JSJ135]:
Visitation requirements are clarified, consistent with 10 CFR Part 35.310.
Document 1 HRG Page 68 of 138
(1)
Routine visitation to hospitalized individuals in accordance with Part 4, Section 1543 4.14.1.1 of these regulations; and 1544 (2)
Visitation authorized in accordance with Part 4, Section 4.14.2; 1545 7.37.1.3(2)
Contamination control; 1546 7.37.1.4(3)
Waste control; and 1547 7.37.1.5(4)
Notification of the RSO, or his or her designee, and thean authorized user if the 1548 patient or the human research subject dies or has a medical emergency or dies.
1549 7.37.32 A licensee shall keepretain a record of individuals receiving safety instructions required by 1550 7.37.1 and maintain such records for 3 years. The record shallmust include a list of the topics 1551 covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the 1552 individual(s) who gaveprovided the instruction.
1553 7.38 Safety Pprecautions.
1554 7.38.1 For each patient or human research subject receiving radiopharmaceutical therapy and 1555 hospitalized for compliance with 7.26 who cannot be released under 7.26, a licensee shall:
1556 7.38.1.1 Quarter the patient or the human research subject either in:
1557 (1)
A private room with a private sanitary facility; or 1558 (2)
A room, with a private sanitary facility, with another individual who also has 1559 received similar radiopharmaceutical therapy with unsealed radioactive 1560 material and who also cannot be released in accordance with 7.26; and 1561 7.38.1.2 Visibly post the patient's or the human research subjects doorroom with a 1562 Caution: Radioactive Materials sign. and 1563 7.38.1.3 Nnote on the door or onin the patient's or the human research subjects chart 1564 where and how long visitors may stay in the patient's or the human research 1565 subjects room; and 1566 7.38.1.34 Either monitor material and items removed from the patient's or the human 1567 research subjects room to determine that their radioactivity cannot be 1568 distinguished from the natural background radiation level with a radiation 1569 detection survey instrument set on its most sensitive scale and with no 1570 interposed shielding, or handle suchthe materials and items as radioactive 1571 waste.
1572 7.38.2 A licensee shall notify the RSO, or his or her designee, and thean authorized user immediately if 1573 the hospitalized patient dies or has a medical emergency and notify the Department as required 1574 by 7.39.as soon as possible if the patient or human research subject has a medical 1575 emergency or dies.
1576 7.39 Emergency Notification.Reserved.
1577 The licensee shall notify the Department in accordance with 7.22 if it is possible that any 1578 individual could receive exposures in excess of 4.14 as a result of a deceased's body.
1579 SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR DIAGNOSIS 1580 Section F - Sealed Sources for Diagnosis 1581 Commented [JSJ136]: 7.37.2 combines the requirements of 10 CFR 35.310 and the recordkeeping requirements of 10 CFR 35.2310.
NRC Compatibility D Commented [JSJ137]: 7.38 is revised for consistency with 10 CFR 35.315.
These changes are not associated with RATS 2018-1.
NRC Compatibility H&S (7.38)
CROSS
REFERENCES:
7.26 = 10 CFR 35.75 Commented [JSJ138]: This provision is redundant with the requirements of 7.22 and is therefore deleted here.
Document 1 HRG Page 69 of 138
7.40 Use of Sealed Sources for Diagnosis.Use of sealed sources and medical devices for 1582 diagnosis.
1583 7.40.1 A licensee shall use for diagnostic medical uses only sealed sources:
1584 7.40.1.1 Approved in the Sealed Source and Device Registry; and 1585 7.40.1.2 Handled in accordance with the manufacturer's radiation safety and handling 1586 instructions:
1587 7.40.1 A licensee must use only sealed sources that are not in medical devices for diagnostic 1588 medical uses if the sealed sources are approved in the Sealed Source and Device Registry 1589 for diagnostic medicine. The sealed sources may be used for diagnostic medical uses that 1590 are not explicitly listed in the Sealed Source and Device Registry but must be used in 1591 accordance with the radiation safety conditions and limitations described in the Sealed 1592 Source and Device Registry.
1593 7.40.2 A licensee must only use medical devices containing sealed sources for diagnostic 1594 medical uses if both the sealed sources and medical devices are approved in the Sealed 1595 Source and Device Registry for diagnostic medical uses. The diagnostic medical devices 1596 may be used for diagnostic medical uses that are not explicitly listed in the Sealed Source 1597 and Device Registry but must be used in accordance with the radiation safety conditions 1598 and limitations described in the Sealed Source and Device Registry.
1599 7.40.3 Sealed sources and devices for diagnostic medical uses may be used in research in 1600 accordance with and active Investigational Device Exemption (IDE) application accepted 1601 by the U.S. Food and Drug Administration provided the requirements of 7.14.1 are met.
1602 7.40.24 Authorized User Training For Use Of Sealed Sources For Diagnosis.Training for use of sealed 1603 sources and medical devices for diagnosis.
1604 The licensee shall require an authorized user under 7.40 to meet the requirements of Appendix 1605 7J.
1606 SPECIFIC REQUIREMENTS FOR THE USE OF SEALED SOURCES FOR MANUAL 1607 BRACHYTHERAPY 1608 Section G - Manual Brachytherapy 1609 7.41 Calibration Measurements of Brachytherapy Sealed Sources.Calibration measurements of 1610 brachytherapy sources.
1611 7.41.1 Prior toBefore the first medical use of a brachytherapy sealed source on or after October 25, 1612 2005, a licensee shall perform the followinghave:
1613 7.41.1.1 Determined the source output or activity using a dosimetry system that meets the 1614 requirements of 7.53; 1615 7.41.1.2 Determined source positioning accuracy within applicators; and 1616 7.41.1.3 Used published protocols currently accepted by nationally recognized bodies to 1617 meet the requirements of 7.41.1.1 and 7.41.1.2.
1618 7.41.2 A Instead of a licensee making its own measurements as required in 7.41.1, the licensee 1619 may use measurements provided by the source manufacturer or by a calibration laboratory 1620 accredited by the American Association of Physicists in Medicine that are made in accordance 1621 with 7.41.1.
1622 Commented [JSJ139]: 7.40 is revised for consistency with 10 CFR 35.500 as a result of 2018 changes to 10 CFR 35 (RATS 2018-1).
NRC Compatibility C (7.40)
CROSS REFERENCES IN THIS SECTION:
7.14.1 = 10 CFR 35.49(a)
Commented [JSJ140]: Section 7.41 is updated for consistency with the wording of 10 CFR 35.432. These changes are not associated with NRC RATS 2018-1.
CROSS
REFERENCES:
7.53 = 10 CFR 35.630(a)
Document 1 HRG Page 70 of 138
7.41.3 A licensee shall mathematically correct the outputs or activities determined in 7.41.1 for physical 1623 decay at intervals consistent with 1.0 percent physical decay.
1624 7.41.4 An authorized medical physicist shall perform or review the measurements and calculations made 1625 pursuant to 7.41.1, 7.41.2, or 7.41.3.
1626 7.41.5 A licensee shall retain a record of each calibration as follows:
1627 1628 7.41.5.1 A licensee shall maintain a record of the calibrations of brachytherapy 1629 sources required by 7.41.1 for 3 years after the last use of the source.
1630 1631 7.41.5.2 The record must include:
1632 1633 (1)
The date of the calibration; 1634 1635 (2)
The manufacturer's name, model number, and serial number for the 1636 source and the instruments used to calibrate the source; 1637 1638 (3)
The source output or activity; 1639 1640 (4)
The source positioning accuracy within the applicators; and 1641 1642 (5)
The name of the individual, the source manufacturer, or the 1643 calibration laboratory that performed the calibration.
1644 7.41.6 Strontium-90 sources for ophthalmic treatments.
1645 7.41.5 Only an authorized medical physicist shall calculate the activity of each strontium-90 source that 1646 is used to determine the treatment times for ophthalmic treatments. The actual source output 1647 shall consider decay based on the activity determined in accordance with paragraphs 7.41.1, 1648 7.41.2, or 7.41.3.
1649 7.41.6.1 Licensees who use strontium-90 for ophthalmic treatments must ensure 1650 that certain activities as specified in 7.41.6.2 are performed by either:
1651 (1)
An authorized medical physicist; or 1652 (2)
An individual who:
1653 (a)
Is identified as an ophthalmic physicist on a specific medical use 1654 license issued by NRC or an Agreement State; permit issued by a 1655 NRC or Agreement State broad scope medical use licensee; 1656 medical use permit issued by a NRC master material licensee; or 1657 permit issued by a NRC master material licensee broad scope 1658 medical use permittee; and 1659 (b)
Holds a masters or doctors degree in physics, medical physics, 1660 other physical sciences, engineering, or applied mathematics from 1661 an accredited college or university; and 1662 (c)
Has successfully completed 1 year full-time training in medical 1663 physics and an additional year of full-time work experience under 1664 the supervision of a medical physicist; and 1665 (d)
Has documented training in:
1666 Commented [JSJ141]: Provision revised for consistency with 10 CFR 35.432(d). This provision replaces (prior) 7.41.6.
10 CFR 35.432(d) references 10 CFR 35.2432 for the recordkeeping requirement. In Part 7, the recordkeeping requirement is incorporated into the section that mandates the requirement in the body of the rule.
NRC Compatibility D CROSS
REFERENCES:
7.41.1 = 10 CFR 35.432 Commented [JSJ142]: Language in this section is amended and expanded for consistency with the 2018 amendments to 10 CFR 35.433 as related to the new term and requirements associated with an ophthalmic physicist.
7.41.6.1 (~10 CFR 35.433(a)) = NRC B Compatibility
[Previously, this provision was a compatibility H&S]
7.41.6.3 (~10 CFR 35.433(c)) = NRC D Compatibility All remaining 10 CFR 35.433 provisions paralleled in 7.41.6 are NRC H&S Compatibility NRC RATS 2018-1 CROSS
REFERENCES:
7.41.6.2 = 10 CFR 35.433(b)
Commented [JSJ143]: This provision is revised and replaced by the added language in 7.41.6.2.
Document 1 HRG Page 71 of 138
(i)
The creation, modification, and completion of written 1667 directives; 1668 (ii)
Procedures for administrations requiring a written directive; 1669 and 1670 (iii)
Performing the calibration measurements of brachytherapy 1671 sources as detailed in 7.41.1 through 7.41.5.
1672 7.41.6.2 The individuals who are identified in 7.41.6.1 must:
1673 (1)
Calculate the activity of each strontium-90 source that is used to determine 1674 the treatment times for ophthalmic treatments. The decay must be based 1675 on the activity determined under 7.41.1 through 7.41.5; and 1676 (2)
Assist the licensee in developing, implementing, and maintaining written 1677 procedures to provide high confidence that the administration is in 1678 accordance with the written directive. These procedures must include the 1679 frequencies that the individual meeting the requirements in 7.41.6.1 will 1680 observe treatments, review the treatment methodology, calculate treatment 1681 time for the prescribed dose, and review records to verify that the 1682 administrations were in accordance with the written directives.
1683 7.41.6.3 Licensees must retain a record of the activity of each strontium-90 source 1684 as follows:
1685 (1)
A licensee shall maintain a record of the activity of a strontium-90 source 1686 required by 7.41.6 for the life of the source.
1687 1688 (2)
The record must include:
1689 1690 (a)
The date and initial activity of the source as determined under 1691 7.41.1 through 7.41.5; and 1692 1693 (b)
For each decay calculation, the date and the source activity as 1694 determined under 7.41.6.
1695 7.41.6 A licensee shall retain a record of each calibration on brachytherapy sources required by 7.41.1 1696 for 3 years after the last use of the source. The record must include the date of the calibration; the 1697 manufacturer's name, model number, and serial number for the source and the instruments used 1698 to calibrate the source; the source output or activity; source positioning accuracy within 1699 applicators; and the signature of the authorized medical physicist.
1700 7.41.7 A licensee shall retain a record of decay calculations required by 7.41.5 for the life of the source.
1701 The record must include the date and initial activity of the source as determined under 7.41, and 1702 for each decay calculation, the date, the source activity and the signature of the authorized 1703 medical physicist.
1704 7.42 Use of Ssealed Ssources Ffor Mmanual Bbrachytherapy.
1705 7.42.1 A licensee shall use for manual brachytherapy only sealed sources:A licensee must use only 1706 brachytherapy sources:
1707 7.42.1.1 Approved in the Sealed Source and Device Registry; or for manual 1708 brachytherapy use. The manual brachytherapy sources may be used for 1709 manual brachytherapy uses that are not explicitly listed in the Sealed 1710 Source and Device Registry, but must be used in accordance with the 1711 Commented [JSJ144]: This provision is incorporated for consistency with 10 CFR 35.2433.
This provision replaces the current requirement found in (prior) 7.41.7 (below), although the Part 35 requirement does not explicitly require the medical physicist signature. It is implied however since a medical physicist is required to perform activity calculations.
NRC Compatibility D (35.2433).
Commented [JSJ145]: This provision is replaced by 7.41.5 (above) to better align with the format and wording of 10 CFR
- 35.
Commented [JSJ146]: This provision is replaced by 7.41.6.3 (above).
Commented [JSJ147]: This provision is updated for consistency with the 2018 amendments to 10 CFR 35.400.
Similar to the proposed requirements in 7.40, the language here is modified to clarify that sources may be used for purposes not explicitly listed in the Sealed Source and Device Registry.
NRC Compatibility C NRC RATS 2018-1 Document 1 HRG Page 72 of 138
radiation safety conditions and limitations described in the Sealed Source 1712 and Device Registry; or 1713 7.42.1.2 In research to deliver therapeutic doses for medical use in accordance with 1714 an effectiveactive Investigational Device Exemption (IDE) application accepted 1715 by the FDA provided the requirements of 7.14.1 are met.
1716 7.42.2 Authorized User Training For Use Of Sealed Sources For Manual Brachytherapy.
1717 The licensee shall require an authorized user under 7.42 to meet the requirements of Appendix 1718 7K.
1719 7.42.3 Authorized User Training For Use Of Strontium-90 Sealed Sources For Ophthalmic Uses.
1720 The licensee shall require an authorized user of strontium-90 sealed sources for ophthalmic uses 1721 under 7.42 to meet the requirements of Appendix 7L.
1722 7.43 Safety Iinstruction.
1723 In addition to the requirements of Part 10 of these regulations:
1724 7.43.1 The licensee shall provide radiation safety instruction, initially and at least annually, to personnel 1725 caring for patients or human research subjects that are undergoing implant therapy and cannot 1726 be released in accordance with 7.26.
1727 7.43.2 The instruction required by 7.43.1 shall be commensurate with the duties of the personnel and 1728 include:
1729 7.43.2.1 Size and appearance of the brachytherapy sources; 1730 7.43.2.2 Safe handling and shielding instructions in case of a dislodged source; 1731 7.43.2.3 Patient or human research subject control; 1732 7.43.2.4 Visitor control, including both; 1733 (1)
Routine visitation to hospitalized individuals in accordance with 4.14.1.1; and 1734 (2)
Visitation authorized in accordance with 4.14.3; and 1735 7.43.2.5 Notification of the RSO, or his or her designee, and the authorized user if the 1736 patient or the human research subject dies or has a medical emergency.
1737 7.43.3 A licensee shall keepretain a record of individuals receiving safety instructions required by 1738 7.43.1 and maintain such records for 3 years. The record shallmust include a list of the topics 1739 covered, the date of the instruction, the names(s) of the attendee(s), and the name(s) of the 1740 individual(s) who gaveprovided the instruction.
1741 7.44 Safety Pprecautions.
1742 7.44.1 For each patient or the human research subject that is receiving brachytherapy and cannot be 1743 released in accordance with 7.26, a licensee shall:
1744 7.44.1.1 Not place the patient or the human research subject in the same room with a 1745 patient who is not receiving radiation therapy; 1746 Commented [JSJ148]: 7.43.3 combines the requirements of 10 CFR 35.410 and 10 CFR 35.2310.
NRC Compatibility D Document 1 HRG Page 73 of 138
7.44.1.2 Visibly post the patient's or human research subjects door with a Caution:
1747 Radioactive Material sign and note on the door or on the patient's or human 1748 research subjects chart where and how long visitors may stay in the patient's or 1749 human research subjects room.
1750 7.44.2 A licensee shall have emergency response equipment available near each treatment room to 1751 respond to a source that inadvertently becomes:
1752 7.44.2.1 Dislodged from the patient; or 1753 7.44.2.2 Lodged within the patient following removal of the source applicators.
1754 7.44.3 A licensee shall notify the RSO, or his or her designee, and thean authorized user immediatelyas 1755 soon as possible if the hospitalized patient or human research subject dies or has a medical 1756 emergency or diesand notify the Department as required by 7.39.
1757 7.45 Brachytherapy Ssources Iinventory.
1758 7.45.1 A licensee shall maintain accountability at all times for all brachytherapy sources in storage or 1759 use.
1760 7.45.2 PromptlyAs soon as possible after removing brachytherapy sources from a patient or a human 1761 research subject, a licensee shall return brachytherapy sources to a secure storage area and 1762 count or otherwise verify the number returned to ensure that all sources taken from the storage 1763 area have been returned.
1764 7.45.3 A licensee shall maintain a record of brachytherapy source accountability for 3 years.
1765 7.45.3.1 For temporary implants, the record must include: the number and activity of 1766 sources:
1767 (1)
The number and activity of sources Rremoved from storage, the time and date 1768 they were removed from storage, the name of the individual who removed them 1769 from storage, and the location of use; and 1770 (2)
The number and activity of sources returned to storageNot implanted, the 1771 time and date they were returned to storage, and the name of the individual who 1772 returned them to storage.
1773 7.45.3.2 For permanent implants, the record must include: the number and activity of 1774 sources:
1775 (1)
The number and activity of sources Rremoved from storage, the date they 1776 were removed from storage, and the name of the individual who removed them 1777 from storage; 1778 (2)
The number and activity of sources not implanted, the date they were 1779 Rreturned to storage, the date they were returned to storage, and the name of 1780 the individual who returned them to storage; and 1781 (3)
The number and activity of sources Ppermanently implanted in the patient or 1782 human research subject.
1783 7.46 Surveys After Source Implant and Removal.Surveys after source implant and removal.
1784 7.46.1 Immediately after implanting sources in a patient or a human research subject, the licensee shall 1785 perform a survey to locate and account for all sources that have not been implanted.
1786 Commented [JSJ149]: 7.39 is proposed for deletion due to overlap/redundancy with 7.22, so the reference to that section is deleted here.
Commented [JSJ150]: Some language updated for consistency with 10 CFR 35.406(b).
Commented [JSJ151]: Section 7.45.3 has been formatted for alignment.
Provisions reworded for consistency with the format of 10 CFR 35.2406.
Document 1 HRG Page 74 of 138
7.46.2 Immediately after removing the last temporary implant source from a patient or a human research 1787 subject, the licensee shall perform a radiation survey of the patient with a radiation detection 1788 survey instrument to confirm that all sources have been removed. The licensee shall not release 1789 from confinement for medical care a patient treated by temporary implant until all sources have 1790 been removed.
1791 7.46.3 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.46.1 1792 and 7.6.27.46.2 for 3 years. Each record shallmust include the date and results of the survey, the 1793 survey instrument used, and the name of the individual who made the survey.
1794 7.47 Therapy-related Computer Systems.Therapy-related computer systems.
1795 7.47.1 The licensee shall perform acceptance testing on the treatment planning system in accordance 1796 with published protocols accepted by nationally recognized bodies.
1797 7.47.2 At a minimum, the acceptance testing required by 7.47.1 shall include, as applicable, verification 1798 of:
1799 7.47.2.1 The source-specific input parameters required by the dose calculation algorithm; 1800 7.47.2.12 The accuracy of dose, dwell time, and treatment time calculations at 1801 representative points; 1802 7.47.2.13 The accuracy of isodose plots and graphic displays; and 1803 1804 7.47.2.14 The accuracy of the software used to determine radioactive source positions 1805 from radiographic images.
1806 1807 Section H - Photon Emitting Remote Afterloader Units, Teletheraphy Units, and Gamma 1808 Stereotactic Radiosurgery Units 1809 SPECIFIC REQUIREMENTS FOR PHOTON-EMITTING REMOTE AFTERLOADER UNITS, 1810 TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS 1811 7.48 Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic 1812 Radiosurgery Unit.Use of a sealed source in a remote afterloader unit, teletherapy unit, or 1813 gamma stereotactic radiosurgery unit.
1814 7.48.1 A licensee shall use sealed sources in remote afterloader units, teletherapy units, or gamma 1815 stereotactic radiosurgery units for therapeutic medical uses:
1816 7.48.1.1 Approved in the Sealed Source and Device Registry; and 1817 7.48.1.2 In research in accordance with an active Investigational Device Exemption (IDE) 1818 application accepted by the FDA provided the requirements of 7.14.1 are met.
1819 7.48.1 A licensee must only use sealed sources:
1820 7.48.1.1 Approved and as provided for in the Sealed Source and Device Registry in 1821 photon emitting remote afterloader units, teletherapy units, or gamma 1822 stereotactic radiosurgery units to deliver therapeutic doses for medical 1823 uses; or 1824 7.48.1.2 In research involving photon-emitting remote afterloader units, teletherapy 1825 units, or gamma stereotactic radiosurgery units in accordance with an 1826 active Investigational Device Exemption (IDE) application accepted by the 1827 Commented [JJ152]: Correction of numbering error.
Commented [JSJ153]: Due to changes in wording this provision is replaced in its entirety by new provision 7.48.1.
Commented [JSJ154]: As a result of the 2018 amendments to 10 CFR 35.600, this provision is revised.
Consistent with federal rule, the revised provision makes a distinction between the devices (afterloader, teletherapy, gamma stereotactic radiosurgery units) and the radioactive sources contained within these units as there is typically a separate sealed source and device registry (SSDR) for each.
Additionally, the wording is revised to allow the units to be used for medical uses that are not explicitly listed in the SSDR.
NRC RATS 2018-1 NRC Compatibility C CROSS
REFERENCES:
7.14.1 = 10 CFR 35.49(a)
Document 1 HRG Page 75 of 138
U.S. Food and Drug Administration provided the requirements of 7.14.1 are 1828 met.
1829 1830 7.48.2 A licensee must use photon-emitting remote afterloader units, teletherapy units, or gamma 1831 stereotactic radiosurgery units:
1832 1833 7.48.2.1 Approved in the Sealed Source and Device Registry to deliver a therapeutic 1834 dose for medical use. These devices may be used for therapeutic medical 1835 treatments that are not explicitly provided for in the Sealed Source and 1836 Device Registry, but must be used in accordance with radiation safety 1837 conditions and limitations described in the Sealed Source and Device 1838 Registry; or 1839 1840 7.48.2.2 In research in accordance with an active Investigational Device Exemption 1841 (IDE) application accepted by the FDA provided the requirements of 7.14.1 1842 are met.
1843 7.48.27.48.3 Authorized User Training For Use of a Remote Afterloader Unit, Teletherapy Unit, or 1844 Gamma Stereotactic Radiosurgery Unit.
1845 The licensee shall require an authorized user under 7.48 to meet the requirements of Appendix 1846 7M.
1847 7.49 Installation, Mmaintenance, Aadjustment, and Rrepair.
1848 7.49.1 Only a person specifically licensed by the Department, another Agreement State, or the NRC 1849 shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma 1850 stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving 1851 unit, or other electronic or mechanical component that could expose the source(s), reduce the 1852 shielding around the source(s), or compromise the radiation safety of the unit or the source(s).
1853 7.49.2 Except for low dose-rate remote afterloader units, only a person specifically licensed by the 1854 Department, another Agreement State, a Licensing State, or the NRC shall install, replace, 1855 relocate, or remove a sealed source or source contained in other remote afterloader units, 1856 teletherapy units, or gamma stereotactic radiosurgery units.
1857 7.49.3 For a low dose-rate remote afterloader unit, only a person specifically licensed by the 1858 Department, another Agreement State, a Licensing State, or the NRC, or an authorized medical 1859 physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.
1860 7.49.4 A licensee shall retain a record of the installation, maintenance, adjustment and repair done onof 1861 remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units for 3 years.
1862 For each installation, maintenance, adjustment and repair, Tthe record shallmust include the 1863 date, description of the service, and name(s) of the individual(s) who performed the work.
1864 7.50 Surveys of Patients and Human Research Subjects Treated with a Remote Afterloader 1865 Unit.Surveys of patients and human research subjects treated with a remote afterloader.
1866 7.50.1 Before releasing a patient or a human research subject from licensee control, a licensee shall 1867 make a survey of the patient or the human research subject and the remote afterloader unit with a 1868 portable radiation detection survey instrument to confirm that the source(s) has been removed 1869 from the patient or human research subject and returned to the safe, shielded position.
1870 7.50.2 A licensee shall maintain a record of patient surveys which demonstrate compliance with 7.50.1 1871 for 3 years. Each record shall include the date and results of the survey, the survey instrument 1872 used, and the name of the individual who made the survey.
1873 Commented [JSJ155]: Language modified for consistency with 10 CFR 35.2605.
Document 1 HRG Page 76 of 138
7.51 Safety Procedures and Instructions for a Remote Afterloader Unit, Teletherapy Unit, or Gamma 1874 Stereotactic Radiosurgery Unit.Safety procedures and instructions for remote afterloader 1875 units, teletherapy units, or gamma stereotactic radiosurgery units.
1876 7.51.1 A licensee shall:
1877 7.51.1.1 Secure the unit, the console, the console keys, and the treatment room when not 1878 in use or unattended; 1879 7.51.1.2 Permit only individuals approved by the authorized user, RSO, or authorized 1880 medical physicist to be present in the treatment room during treatment with the 1881 source(s), if such presence is necessary and justified; 1882 7.51.1.3 Prevent dual operation of more than one radiation producing device in a 1883 treatment room, if applicable; and 1884 7.51.1.4 Develop, implement, and maintain written procedures for responding to an 1885 abnormal situation when the operator is unable to place the source(s) in the 1886 shielded position, or remove the patient or human research subject from the 1887 radiation field with controls from outside the treatment room. ThisThese 1888 procedures must include:
1889 (1)
Instructions for responding to equipment failures and the names of the individuals 1890 responsible for implementing corrective actions; 1891 (2)
The process for restricting access to and posting of the treatment area to 1892 minimize the risk of inadvertent exposure; and 1893 (3)
The names and telephone numbers of the authorized users, the authorized 1894 medical physicist, and the RSO to be contacted if the unit or console operates 1895 abnormally.
1896 7.51.2 A copy of the procedures required by 7.51.1.4 shallmust be physically located at the unit console.
1897 7.51.3 A licensee shall conspicuously post instructions at the unit console to inform the operator of the 1898 names and telephone numbers of the authorized users, the authorized medical physicist, and the 1899 RSO to be contacted if the unit or console operates abnormally.A licensee shall post 1900 instructions at the unit console to inform the operator of:
1901 7.51.3.1 The location of the procedures required by 7.51.1.4; and 1902 7.51.3.2 The names and telephone numbers of the authorized users, the authorized 1903 medical physicist, and the Radiation Safety Officer to be contacted if the 1904 unit or console operates abnormally.
1905 7.51.4 Operational and safety training.
1906 1907 7.51.4.1 Prior to the first use for patient treatment of a new unit or an existing unit 1908 with a manufacturer upgrade that affects the operation and safety of the 1909 unit, a licensee shall ensure that vendor operational and safety training is 1910 provided to all individuals who will operate the unit. The vendor operational 1911 and safety training must be provided by the device manufacturer or by an 1912 individual certified by the device manufacturer to provide the operational 1913 and safety training.
1914 7.51.4.2 A licensee shall provide operational and safety instructions, initially and at least 1915 annually, to all individuals who operate athe unit at the facility, as appropriate to 1916 Commented [JSJ156]: Reformatted to remove capitalization and for consistency with wording of 10 CFR 35.610. Section has been formatted for alignment.
Commented [JSJ157]: Provision revised to fit the format of 10 CFR 35.610(c).
Commented [JSJ158]: This sub-section heading is added for formatting and numbering purposes to parallel/maintain consistency with the flow and format of 10 CFR 35.610(d).
Commented [JSJ159]: This is a new provision added for consistency with the 2018 amendments/additions to 10 CFR
- 35. 610(d).
This requirement specifies that training must be provided by the vendor or individual certified by the device manufacturer following an upgrade impacting the operation and safety of the unit and prior to the first use on a patient. Also see NRC FAQ
- 51, #52 for further information.
NRC RATS 2018-1 NRC Compatibility H&S for all but 35.610(f) / 7.51.6, which is compatibility D Document 1 HRG Page 77 of 138
the individual's assigned duties., in: The instructions shall include instruction 1917 in:
1918 7.51.4.1(1)
The procedures identified in 7.51.1.4; and 1919 7.51.4.2(2)
The operating procedures for the unit.
1920 7.51.5 A licensee shall ensure that operators, authorized medical physicists, and authorized users 1921 participate in drills of the emergency procedures, initially and at least annually.
1922 7.51.6 A licensee shall keepretain a record of individuals receiving instruction required by 7.51.4 in 1923 accordance with the following:and maintain such records for 3 years. The record shall include 1924 a list of the topics covered, the date of instruction, the names(s) of the attendee(s), and the 1925 name(s) of the individual(s) who gave the instruction.
1926 (1)
A licensee shall maintain a record of the operational and safety instructions 1927 required by 7.51.4 for 3 years. The record must include a list of the topics covered, 1928 the date of the instruction, the name(s) of the attendee(s), and the name(s) of the 1929 individual(s) who provided the instruction.
1930 7.51.7 A licensee shall retain a copy of the procedures required by 7.51.1.4 and 7.51.4.2(2) until 1931 the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma 1932 stereotactic radiosurgery unit.
1933 7.52 Doors, Interlocks, and Warning Systems.Safety precautions for remote afterloader units, 1934 teletherapy units, and gamma stereotactic radiosurgery units.
1935 7.52.1 A licensee shall control access to the treatment room by a door at each entrance.
1936 7.52.2 A licensee shall equip each entrance to the treatment room with an electrical interlock system that 1937 shallwill:
1938 7.52.2.1 Prevent the operator from initiating the treatment cycle unless each treatment 1939 room entrance door is closed; 1940 7.52.2.2 Cause the source(s) to be shielded promptly when an entrance door is opened; 1941 and 1942 7.52.2.3 Prevent the source(s) from being exposed following an interlock interruption until 1943 all treatment room entrance doors are closed and the source(s) on/off control is 1944 reset at the console.
1945 7.52.3 A licensee shall require any individual entering the treatment room to assure, through the use of 1946 appropriate radiation monitors, that radiation levels have returned to ambient levels.
1947 7.52.4 Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment 1948 room with viewing and intercom systems to permit continuous observation of the patient or the 1949 human research subject from the treatment console during irradiation.
1950 7.52.5 For licensed activities where sources are placed within the patient's or human research subject's 1951 body, a licensee shall only conduct treatments which allow for expeditious removal of a 1952 decoupled or jammed source.
1953 7.52.6 In addition to the requirements specified in 7.52.1 through 7.52.5, a licensee shall:
1954 7.52.6.1 For low dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader 1955 units, require:
1956 Commented [JSJ160]: This provision has been reformatted to better align with language in 10 CFR 35.610(f) and 10 CFR 35.2310.
The proposed language does not significantly change the current requirements.
NRC RATS 2018-1 NRC Compatibility D (for 35.610(f) and 35.2310)
Commented [JSJ161]: Added for consistency with 10 CFR 35.610(g) and 10 CFR 35.2610. The proposed provision combines the requirements of these two provisions.
Provision (g) of 10 CFR 35.610 was revised as a result of the 2018 amendments.
NRC RATS 2018-1 NRC Compatibility H&S Commented [JSJ162]: Title of this section revised for consistency with 10 CFR 35.615.
Provisions in 7.52 have been formatted for alignment which is not indicated by strikeout/revised text.
Document 1 HRG Page 78 of 138
(1)
An authorized medical physicist and either an authorized user or a physician, 1957 under the supervision of an authorized user, who has been trained in the 1958 operation and emergency response for the unit, to be physically present during 1959 the initiation of all patient treatments involving the unit; and 1960 (2)
An authorized medical physicist and either an authorized user or an individual, 1961 under the supervision of an authorized user, who has been trained to remove the 1962 source applicator(s) in the event of an emergency involving the unit, to be 1963 immediately available during continuation of all patient treatments involving the 1964 unit.
1965 7.52.6.2 For high dose-rate remote afterloader units, require:
1966 (1)
An authorized user and an authorized medical physicist to be physically present 1967 during the initiation of all patient treatments involving the unit; and 1968 (2)
An authorized medical physicist and either an authorized user or a physician, 1969 under the supervision of an authorized user, who has been trained in the 1970 operation and emergency response for the unit, to be physically present during 1971 continuation of all patient treatments involving the unit.
1972 7.52.6.3 For gamma stereotactic radiosurgery units, require an authorized user and an 1973 authorized medical physicist to be physically present throughout all patient 1974 treatments involving the unit.
1975 7.52.6.4 If a patient or research subject suffers a medical emergency during radiation 1976 therapy:
1977 (1)
Cease the therapy immediately; 1978 (2)
Remove the source(s); and 1979 (3)
Provide appropriate care to the patient or research subject.
1980 7.52.6.5 If the patient expires during treatment, remove the source(s) before further 1981 actions are taken.
1982 7.52.6.6 Notify the RSO, or his or her designee, and an authorized user as soon as 1983 possible, if the patient or human research subject has a medical emergency and, 1984 immediately, if the patient dies.
1985 7.52.7 A licensee shall have applicable emergency response equipment available near each treatment 1986 room, to respond to a situation in which a source inadvertentlysource:
1987 7.52.7.1 RemainsRemaining in the unshielded position; or 1988 7.52.7.2 Lodgesd within the patient following completion of the treatment.
1989 7.53 Dosimetry Eequipment.
1990 7.53.1 Except for low dose-rate remote afterloader sources where the source output or activity is 1991 determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for 1992 use. To satisfy this requirement, one of the following two conditions shallmust be met:
1993 7.53.1.1 The system shallmust have been calibrated using a system or source traceable 1994 to the National Institute of Standards and Technology and published protocols 1995 accepted by nationally recognized bodies, or by a calibration laboratory 1996 Document 1 HRG Page 79 of 138
accredited by the American Association of Physicists in Medicine. The calibration 1997 shall have been performed within the previous 2 years and after any servicing 1998 that may have affected system calibration; or 1999 7.53.1.2 The system shallmust have been calibrated within the previous 4 years; 18 to 30 2000 months after that calibration, the system shall have been intercompared with 2001 another dosimetry system that was calibrated within the past 24 months by the 2002 National Institute of Standards and Technology or by a calibration laboratory 2003 accredited by the American Association of Physicists in Medicine. The results of 2004 the intercomparison must have indicated that the calibration factor of the 2005 licensee's system had not changed by more than 2 percent. The licensee shall 2006 not use the intercomparison result to change the calibration factor. When 2007 intercomparing dosimetry systems to be used for calibrating sealed sources for 2008 therapeutic units, the licensee shall use a comparable unit with beam attenuators 2009 or collimators, as applicable, and sources of the same radionuclide as the source 2010 used at the licensee's facility.
2011 7.53.2 The licensee shall have available for use a dosimetry system for spot-check output 2012 measurements. To meet this requirement, the system may be compared with a system that has 2013 been calibrated in accordance with 7.53.1. This comparison shall have been performed within the 2014 previous year and after each servicing that may have affected system calibration. The spot-check 2015 system may be the same system used to meet the requirement in 7.53.1.
2016 7.53.3 The licensee shall maintainretain a record of each calibration, intercomparison, and comparison 2017 for the duration of the license. For each calibration, intercomparison, or comparison, the record 2018 shallmust include:
2019 7.53.3.1 The date; 2020 7.53.3.2 The manufacturers name, the model numbers and serial numbers of the 2021 instruments that were calibrated, intercompared, or compared as required by 2022 7.53.1 and 7.53.2; 2023 7.53.3.3 The correction factor that werewas determined from the calibration or 2024 comparison or the apparent correction factor that was determined from an 2025 intercomparison; 2026 7.53.3.4 The names of the individuals who performed the calibration, intercomparison, or 2027 comparison.
2028 7.54 Full Ccalibration Mmeasurements on Tteletherapy Uunits.
2029 7.54.1 A licensee authorized to use a teletherapy unit for medical use shall perform full calibration 2030 measurements on each teletherapy unit:
2031 7.54.1.1 Before the first medical use of the unit; 2032 7.54.1.2 Before medical use under the following conditions:
2033 (1)
Whenever spot-check measurements indicate that the output differs by more 2034 than 5 percent from the output obtained at the last full calibration corrected 2035 mathematically for radioactive decay; 2036 (2)
Following replacement of the source or following reinstallation of the teletherapy 2037 unit in a new location; and 2038 Document 1 HRG Page 80 of 138
(3)
Following any repair of the teletherapy unit that includes removal of the source or 2039 major repair of the components associated with the source exposure assembly; 2040 and 2041 7.54.1.3 At intervals not exceeding 1 year.
2042 7.54.2 To satisfy the requirement of 7.54.1, full calibration measurements shall include determination of:
2043 7.54.2.1 The output within +/- 3 percent for the range of field sizes and for the distance or 2044 range of distances used for medical use; 2045 7.54.2.2 The coincidence of the radiation field and the field indicated by the light beam 2046 localizing device; 2047 7.54.2.3 The uniformity of the radiation field and its dependence on the orientation of the 2048 useful beam; 2049 7.54.2.4 Timer accuracy, constancy, and linearity; 2050 7.54.2.5 On off error; and 2051 7.54.2.6 The accuracy of all distance measuring and localization devices in medical use.
2052 7.54.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of 2053 exposure conditions. The remaining radiation measurements required in 7.54.2.1 may then be 2054 made using a dosimetry system that indicates relative dose rates.
2055 7.54.4 A licensee shall make full calibration measurements required by 7.54.1 in accordance with 2056 published protocols accepted by nationally recognized bodies.
2057 7.54.5 A licensee shall correct mathematically the outputs determined in 7.54.2.1 for physical decay for 2058 intervals not exceeding 1 month for cobalt 60, 6 months for cesium 137, or at intervals consistent 2059 with 1 percent decay for all other nuclides.
2060 7.54.6 Full calibration measurements required by 7.54.1 and physical decay corrections required by 2061 7.54.5 shall be performed by the authorized medical physicist.
2062 7.54.7 A licensee shall maintain a record of each calibration for the duration of the license. The record 2063 shall include:
2064 7.54.7.1 The date of the calibration; 2065 7.54.7.2 The manufacturer's name, model number, and serial number for the teletherapy 2066 unit, source(s), and instruments used to calibrate the teletherapy unit; 2067 7.54.7.3 The results and assessments of the full calibrations; and 2068 7.54.7.4 The signature of the authorized medical physicist who performed the full 2069 calibration.
2070 7.55 Full Ccalibration Mmeasurements on Rremote Aafterloader Uunits.
2071 7.55.1 A licensee authorized to use a remote afterloader unit for medical use shall perform full 2072 calibration measurements on each unit:
2073 7.55.1.1 Before the first medical use of the unit; 2074 Document 1 HRG Page 81 of 138
7.55.1.2 Before medical use under the following conditions:
2075 (1)
Following replacement of the source or following reinstallation of the unit in a new 2076 location outside the facility; and 2077 (2)
Following any repair of the unit that includes removal of the source or major 2078 repair of the components associated with the source exposure assembly; and 2079 7.55.1.3 At intervals not exceeding one (1) calendar quarter for high dose-rate, medium 2080 dose-rate, and pulsed dose-rate remote afterloader units with sources whose 2081 half-life exceeds 75 days; and 2082 7.55.1.4 At intervals not exceeding 1 year for low dose-rate remote afterloader units.
2083 7.55.2 To satisfy the requirement of 7.55.1, full calibration measurements must include, as applicable, 2084 determination of:
2085 7.55.2.1 The output within +/- 5 percent; 2086 7.55.2.2 Source positioning accuracy to within +/- 1 millimeter; 2087 7.55.2.3 Source retraction with backup battery upon power failure; 2088 7.55.2.4 Length of the source transfer tubes; 2089 7.55.2.5 Timer accuracy and linearity over the typical range of use; 2090 7.55.2.6 Length of the applicators; and 2091 7.55.2.7 Function of the source transfer tubes, applicators, and transfer tube-applicator 2092 interfaces.
2093 7.55.3 In addition to the requirements for full calibrations for low dose-rate remote afterloader units in 2094 7.55.2, a licensee shall perform an autoradiograph of the source(s) to verify inventory and 2095 source(s) arrangement at intervals not exceeding one quarter.
2096 7.55.4 A licensee shall use the dosimetry system described in 7.53 to measure the output.
2097 7.55.5 A licensee shall make full calibration measurements required by 7.55.1 of this section in 2098 accordance with published protocols accepted by nationally recognized bodies.
2099 7.55.6 For low dose-rate remote afterloader units, a licensee may use measurements provided by the 2100 source manufacturer that are made in accordance with 7.55.1 through 7.55.5.
2101 7.55.7 A licensee shall mathematically correct the outputs determined in 7.55.2.1 for physical decay at 2102 intervals consistent with 1 percent physical decay.
2103 7.55.8 Full calibration measurements required by 7.55.1 and physical decay corrections required by 2104 7.55.7 must be performed by the authorized medical physicist.
2105 7.55.9 A licensee shall retain a record of each calibration for the duration of the license. The record shall 2106 include:
2107 7.55.9.1 The date of the calibration; 2108 Document 1 HRG Page 82 of 138
7.55.9.2 The manufacturer's name, model number, and serial number for the remote 2109 afterloader unit, source(s), and instruments used to calibrate the remote 2110 afterloader unit; 2111 7.55.9.3 The results and assessments of the full calibrations; 2112
- 7. 55.9.4 The results of the autoradiograph required for low dose-rate remote afterloader 2113 units; and 2114
- 7. 55.9.5 The signature of the authorized medical physicist who performed the full 2115 calibration.
2116 7.56 Full Ccalibration Mmeasurements on Ggamma Sstereotactic Rradiosurgery Uunits.
2117 7.56.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall 2118 perform full calibration measurements on each unit:
2119 7.56.1.1 Before the first medical use of the unit; 2120 7.56.1.2 Before medical use under the following conditions:
2121 (1)
Whenever spot-check measurements indicate that the output differs by more 2122 than 5 percent from the output obtained at the last full calibration corrected 2123 mathematically for radioactive decay; 2124 (2)
Following replacement of the sources or following reinstallation of the gamma 2125 stereotactic radiosurgery unit in a new location; and 2126 (3)
Following any repair of the gamma stereotactic radiosurgery unit that includes 2127 removal of the sources or major repair of the components associated with the 2128 source assembly; and 2129 7.56.1.3 At intervals not exceeding 1 year, with the exception that relative helmet factors 2130 need only be determined before the first medical use of a helmet and following 2131 any damage to a helmet.
2132 7.56.2 To satisfy the requirement of 7.56.1, full calibration measurements must include determination of:
2133 7.56.2.1 The output within +/-3 percent; 2134 7.56.2.2 Relative helmet factors; 2135 7.56.2.3 Isocenter coincidence; 2136 7.56.2.4 Timer accuracy and linearity over the range of use; 2137 7.56.2.5 On-off error; 2138 7.56.2.6 Trunnion centricity; 2139 7.56.2.7 Treatment table retraction mechanism, using backup battery power or hydraulic 2140 backups with the unit off; 2141 7.56.2.8 Helmet microswitches; 2142 7.56.2.9 Emergency timing circuits; and 2143 Document 1 HRG Page 83 of 138
7.56.2.10 Stereotactic frames and localizing devices (trunnions).
2144 7.56.3 A licensee shall use the dosimetry system described in 7.53 to measure the output for one set of 2145 exposure conditions. The remaining radiation measurements required in 7.56.2.1 may be made 2146 using a dosimetry system that indicates relative dose rates.
2147 7.56.4 A licensee shall make full calibration measurements required by 7.56.1 in accordance with 2148 published protocols accepted by nationally recognized bodies.
2149 7.56.5 A licensee shall mathematically correct the outputs determined in 7.56.2.1 at intervals not 2150 exceeding 1 month for cobalt-60 and at intervals consistent with 1 percent physical decay for all 2151 other radionuclides.
2152 7.56.6 Full calibration measurements required by 7.56.1 and physical decay corrections required by 2153 7.56.5 must be performed by the authorized medical physicist.
2154 7.56.7 A licensee shall retain a record of each calibration for the duration of the license. The record shall 2155 include:
2156
- 7. 56.7.1 The date of the calibration; 2157
- 7. 56.7.2 The manufacturer's name, model number, and serial number for the gamma 2158 stereotactic radiosurgery unit, source(s), and instruments used to calibrate the 2159 gamma stereotactic radiosurgery unit; 2160
- 7. 56.7.3 The results and assessments of the full calibrations; 2161
- 7. 56.7.4 The signature of the authorized medical physicist who performed the full 2162 calibration.
2163 7.57 Radiation Ssurveys of Ttherapeutic Ttreatment Uunits.
2164 7.57.1 A licensee authorized to use radioactive material in remote afterloader units, teletherapy units, 2165 and gamma stereotactic radiosurgery units shall possess a portable radiation detection survey 2166 instrument capable of detecting dose rates over the range of 1 µSv (0.1 mrem) per hour to 500 2167
µSv (50 mrem) per hour, and a portable radiation measurement survey instrument capable of 2168 measuring dose rates over the range of 10 µSv (1 mrem) per hour to 10 mSv (1 rem) per hour.
2169 The instruments shall be operable and calibrated in accordance with 7.17.
2170 7.57.2 In addition to the survey requirements in Part 4 of these regulations, a person licensed pursuant 2171 to Part 7 shall make surveys to ensure that the maximum radiation levels and average radiation 2172 levels from the surface of the main source safe with the source(s) in the shielded position does 2173 not exceed the levels stated in the Sealed Source and Device Registry.
2174 7.57.3 The licensee shall make the survey required by 7.57.2 at installation of a new source and 2175 following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or 2176 mechanical component that could expose the source, reduce the shielding around the source(s),
2177 or compromise the radiation safety of the unit or the source(s).
2178 Records of surveys of therapeutic treatment units 2179 7.57.4 A licensee shall retain a record of the radiation surveys required by 7.57.2 for the duration of use 2180 of the unit. The record must include:
2181 7.57.4.1 The date of the measurements; 2182 Document 1 HRG Page 84 of 138
7.57.4.2 The manufacturer's name, model number and serial number of the treatment 2183 unit, source, and instrument used to measure radiation levels; 2184 7.57.4.3 Each dose rate measured around the source while the unit is in the off position 2185 and the average of all measurements; and 2186 7.57.4.4 The signature of the authorized medical physicistindividual who performed the 2187 test.
2188 7.58 Periodic sSpot Cchecks for Tteletherapy Uunits.
2189 7.58.1 A licensee authorized to use teletherapy units for medical use shall perform output spot checks 2190 on each teletherapy unit once in each calendar month, includingthat include determination of:
2191 7.58.1.1 Timer accuracy, and timer linearity over the range of use; 2192 7.58.1.2 On off error; 2193 7.58.1.3 The coincidence of the radiation field and the field indicated by the light beam 2194 localizing device; 2195 7.58.1.4 The accuracy of all distance measuring and localization devices used for medical 2196 use; 2197 7.58.1.5 The output for one typical set of operating conditions measured with the 2198 dosimetry system described in 7.53; and 2199 7.58.1.6 The difference between the measurement made in 7.58.1.5 and the anticipated 2200 output, expressed as a percentage of the anticipated output (i.e., the value 2201 obtained at last full calibration corrected mathematically for physical decay).
2202 7.58.2 A licensee shall perform spot checks required by 7.58.1 in accordance with procedures 2203 established by the authorized medical physicist. That individual need not actually perform the 2204 output spot-check measurements.
2205 7.58.3 A licensee shall have the authorized medical physicist review the results of each spot check 2206 within 15 days. The authorized medical physicist shall promptly notify the licensee in writing of the 2207 results of each spot check.
2208 7.58.4 A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks 2209 of each teletherapy facility once in each calendar month and after each source installation to 2210 assure proper operation of:
2211 7.58.4.1 Electrical interlocks at each teletherapy room entrance; 2212 7.58.4.2 Electrical or mechanical stops installed for the purpose of limiting use of the 2213 primary beam of radiation restriction of source housing angulation or elevation, 2214 carriage or stand travel, and operation of the beam on off mechanism; 2215 7.58.4.3 Source exposure indicator lights on the teletherapy unit, on the control console, 2216 and in the facility; 2217 7.58.4.4 Viewing and intercom systems; 2218 7.58.4.5 Treatment room doors from inside and outside the treatment room; and 2219 Commented [JSJ163]: 35.2652(b)(4)
Document 1 HRG Page 85 of 138
7.58.4.6 Electrically assisted treatment room doors with the teletherapy unit electrical 2220 power turned off.
2221 7.58.5 If the results of the checks required in 7.58.4 indicate the malfunction of any system, a licensee 2222 shall lock the control console in the off position and not use the unit except as may be 2223 necessary to repair, replace, or check the malfunctioning system.
2224 7.58.6 A licensee shall maintain a record of each spot check required by 7.58.1 and 7.58.54, and a 2225 copy of the procedures required by 7.58.2 for 3 years. The record shall include:
2226 7.58.6.1 The date of the spot check; 2227 7.58.6.2 The manufacturer's name, model number, and serial number for the teletherapy 2228 unit, source, and instrument used to measure the output of the teletherapy unit; 2229 7.58.6.3 An assessment of timer linearity and constancy; 2230 7.58.6.4 The calculated on off error; 2231 7.58.6.5 A determination of the coincidence of the radiation field and the field indicated by 2232 the light beam localizing device 2233 7.58.6.6 The determined accuracy of each distance measuring or localization device; 2234 7.58.6.7 The difference between the anticipated output and the measured output; 2235 7.58.6.8 Notations indicating the operability of each entrance door electrical interlock, 2236 each electrical or mechanical stop, each source exposure indicator light, and the 2237 viewing and intercom system and doors; and 2238 7.58.6.9 The name of the individual who performed the periodic spot check and the 2239 signature of the authorized medical physicist who reviewed the record of the spot 2240 check.
2241 7.59 Periodic Sspot Cchecks for Rremote Aafterloader Uunits.
2242 7.59.1 A licensee authorized to use remote afterloader units for medical use shall perform spot checks of 2243 each remote afterloader facility and on each unit:
2244 7.59.1.1 At the beginning of each day of use of a high dose-rate, medium dose-rate or 2245 pulsed dose-rate remote afterloader unit; 2246 7.59.1.2 Prior to each patient treatment with a low dose-rate remote afterloader unit; and 2247 7.59.1.3 After each source installation.
2248 7.59.2 The licensee shall have the authorized medical physicist establish written procedures for 2249 performing the spot checks required in 7.59.1 The authorized medical physicist need not actually 2250 perform the spot-check measurements.
2251 7.59.3 A licensee shall have the authorized medical physicist review the results of each spot check 2252 within 15 days. The authorized medical physicist shall notify the licensee as soon as possible in 2253 writing of the results of each spot check.
2254 7.59.4 To satisfy the requirements of 7.59.1, spot checks must, at a minimum, assure proper operation 2255 of:
2256 Commented [JSJ164]: Correction of cross-reference error and additional language added for consistency with 10 CFR 35.642(f) to clarify that a copy of the procedures used for spot checks must also be maintained.
7.58.6 combines the provisions of 10 CFR 35.642 and 10 CFR 35.2642.
Document 1 HRG Page 86 of 138
7.59.4.1 Emergency response equipment; 2257 7.59.4.2 Viewing and intercom systems in each high dose-rate, medium dose-rate and 2258 pulsed dose-rate remote afterloader facility; 2259 7.59.4.3 Radiation monitors used to indicate the source position; 2260 7.59.4.4 Electrical interlocks at each remote afterloader unit room entrance; 2261 7.59.4.5 Source exposure indicator lights on the remote afterloader unit, on the control 2262 console, and in the facility; 2263 7.59.4.6 Timer accuracy; 2264 7.59.4.7 Clock (date and time) in the unit's computer; and 2265 7.59.4.8 Decayed source(s) activity in the unit's computer.
2266 7.59.5 If the results of the checks required in 7.59.4 indicate the malfunction of any system, a licensee 2267 shall lock the control console in the off position and not use the unit except as may be necessary 2268 to repair, replace, or check the malfunctioning system.
2269 7.59.6 A licensee shall retain a record of each check required by 7.59.4, and a copy of the procedures 2270 required by 7.59.2 for 3 years. The record must include, as applicable:
2271 7.59.6.1 The date of the spot check; 2272 7.59.6.2 The manufacturer's name, model number, and serial number for the remote 2273 afterloader unit and source; 2274 7.59.6.3 An assessment of timer accuracy; 2275 7.59.6.4 Notations indicating the operability of each entrance door electrical interlock, 2276 radiation monitors, source exposure indicator lights, viewing and intercom 2277 systems, and clock and decayed source activity in the unit's computer; and 2278 7.59.6.5 The name of the individual who performed the periodic spot check and the 2279 signature of the authorized medical physicist who reviewed the record of the spot 2280 check.
2281 7.60 Additional Ttechnical Rrequirements for Mmobile Rremote Aafterloader Uunits.
2282 7.60.1 A licensee providing mobile remote afterloader service shall:
2283 7.60.1.1 Check survey instruments for consistent response before medical use at each 2284 address of use or on each day of use, whichever is more frequent; and 2285 7.60.1.2 Account for all sources before departure from a client's address of use.
2286 7.60.2 In addition to the periodic spot checks required by 7.59, a licensee authorized to use mobile 2287 afterloaders for medical use shall perform checks on each remote afterloader unit before use at 2288 each address of use. At a minimum, checks must be made to verify the operation of:
2289 7.60.2.1 Electrical interlocks on treatment area access points; 2290 7.60.2.2 Source exposure indicator lights on the remote afterloader unit, on the control 2291 console, and in the facility; 2292 Commented [JSJ165]: Additional language added for consistency with 10 CFR 35.643 to clarify that a copy of the procedures used for spot checks must also be maintained.
7.59.6 combines the provisions of 10 CFR 35.643 and 10 CFR 35.2643.
This provision has been formatted and aligned.
Commented [JSJ166]: Select provisions in 7.60 have been formatted for alignment purposes which are not easily reflected by text changes/redlines.
Document 1 HRG Page 87 of 138
7.60.2.3 Viewing and intercom systems; 2293 7.60.2.4 Applicators, source transfer tubes, and transfer tube-applicator interfaces; 2294 7.60.2.5 Radiation monitors used to indicate room exposures; 2295 7.60.2.6 Source positioning (accuracy); and 2296 7.60.2.7 Radiation monitors used to indicate whether the source has returned to a safe 2297 shielded position.
2298 7.60.3 In addition to the requirements for checks in 7.60.2, a licensee shall ensure overall proper 2299 operation of the remote afterloader unit by conducting a simulated cycle of treatment before use 2300 at each address of use.
2301 7.60.4 If the results of the checks required in 7.60.2 indicate the malfunction of any system, a licensee 2302 shall lock the control console in the off position and not use the unit except as may be necessary 2303 to repair, replace, or check the malfunctioning system.
2304 7.60.5 A licensee shall retain a record of each check for mobile remote afterloader units required by 2305 7.60.2 for 3 years. The record must include:
2306 7.60.5.1 The date of the check; 2307 7.60.5.2 The manufacturer's name, model number, and serial number of the remote 2308 afterloader unit; 2309 7.60.5.3 Notations accounting for all sources before the licensee departs from a facility; 2310 7.60.5.4 Notations indicating the operability of each entrance door electrical interlock, 2311 radiation monitors, source exposure indicator lights, viewing and intercom 2312 system, applicators, and source transfer tubes, and source positioning accuracy; 2313 and 2314 7.60.5.5 The signature of the individual who performed the check.
2315 7.61 Periodic Sspot Cchecks for Ggamma Sstereotactic Rradiosurgery Uunits.
2316 7.61.1 A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall 2317 perform spot -checks of each gamma stereotactic radiosurgery facility and on each unit:
2318 7.61.1.1 Monthly; 2319 7.61.1.2 At the beginning of each day of useBefore the first use on a given day; and 2320 7.61.1.3 After each source installation.
2321 7.61.2 The licensee shall have the authorized medical physicist:A licensee shall:
2322 7.61.2.1 Establish written procedures for performing the spot checks required in 7.61.1; 2323 andPerform the measurements required by 7.61.1 in accordance with 2324 written procedures established by the authorized medical physicist. That 2325 individual need not actually perform the spot check measurements.
2326 7.61.2.2 Have the authorized medical physicist Rreview the results of each spot -check 2327 required by 7.61.1.1 within 15 days. of the check. The authorized medical 2328 physicist need not actually perform the spot-check measurements. The 2329 Commented [JSJ167]: Section 7.61.2 revised for consistency with 10 CFR 35.645. This change is not a RATS item.
Commented [JSJ168]: The language regarding the AMP not being required to perform the spot check is incorporated into 7.61.2.1 (above).
Document 1 HRG Page 88 of 138
authorized medical physicist shall notify the licensee as soon as possible, in 2330 writing, of the results of theeach spot -check.
2331 7.61.3 To satisfy the requirements of 7.61.1.1 spot checks must, at a minimum:
2332 7.61.3.1 Assure proper operation of:
2333 (1)
Treatment table retraction mechanism, using backup battery power or hydraulic 2334 backups with the unit off; 2335 (2)
Helmet microswitches; 2336 (3)
Emergency timing circuits; and 2337 (4)
Stereotactic frames and localizing devices (trunnions).
2338 7.61.3.2 Determine:
2339 (1)
The output for one typical set of operating conditions measured with the 2340 dosimetry system described in 7.53.2; 2341 (2)
The difference between the measurement made in 7.61.3.2(1) and the 2342 anticipated output, expressed as a percentage of the anticipated output (i.e., the 2343 value obtained at last full calibration corrected mathematically for physical 2344 decay);
2345 (3)
Source output against computer calculation; 2346 (4)
Timer accuracy and linearity over the range of use; 2347 (5)
On-off error; and 2348 (6)
Trunnion centricity.
2349 7.61.4 To satisfy the requirements of 7.61.1.2 and 7.61.1.3, spot -checks must assure proper operation 2350 of:
2351 7.61.4.1 Electrical interlocks at each gamma stereotactic radiosurgery room entrance; 2352 7.61.4.2 Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on 2353 the control console, and in the facility; 2354 7.61.4.3 Viewing and intercom systems; 2355 7.61.4.4 Timer termination; 2356 7.61.4.5 Radiation monitors used to indicate room exposures; and 2357 7.61.4.6 Emergency off buttons.
2358 7.61.5 A licensee shall arrange for prompt repair of any system identified in 7.61.3 that is not operating 2359 properly.
2360 7.61.6 If the results of the checks required in 7.61.4 indicate the malfunction of any system, a licensee 2361 shall lock the control console in the off position and not use the unit except as may be necessary 2362 to repair, replace, or check the malfunctioning system.
2363 Document 1 HRG Page 89 of 138
7.61.7 A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units 2364 required by 7.61.3 and 7.61.4 for 3 years. The record must include:
2365 7.61.7.1 The date of the spot check; 2366 7.61.7.2 The manufacturer's name, model number, and serial number for the gamma 2367 stereotactic radiosurgery unit and the instrument used to measure the output of 2368 the unit; 2369 7.61.7.3 An assessment of timer linearity and accuracy; 2370 7.61.7.4 The calculated on-off error; 2371 7.61.7.5 A determination of trunnion centricity; 2372 7.61.7.6 The difference between the anticipated output and the measured output; 2373 7.61.7.7 An assessment of source output against computer calculations; 2374 7.61.7.8 Notations indicating the operability of radiation monitors, helmet microswitches, 2375 emergency timing circuits, emergency off buttons, electrical interlocks, source 2376 exposure indicator lights, viewing and intercom systems, timer termination, 2377 treatment table retraction mechanism, and stereotactic frames and localizing 2378 devices (trunnions); and 2379 7.61.7.9 The name of the individual who performed the periodic spot check and the 2380 signature of the authorized medical physicist who reviewed the record of the spot 2381 check.
2382 7.61.8 A licensee shall retain a copy of the procedures required by 7.61.2 until the licensee no 2383 longer possesses the gamma stereotactic radiosurgery unit.
2384 7.62 Other Mmedical Uuses of Rradioactive Mmaterial or Rradiation Ffrom Rradioactive Mmaterial.
2385 7.62.1 A licensee may use radioactive material or a radiation source approved for medical use that is not 2386 specifically addressed in Part 7 if:
2387 7.62.1.1 The applicant or licensee has submitted the information required by 7.3.4.2, 2388 7.3.4.3, and 7.3.4.4; and 2389 7.62.1.2 The applicant or licensee has received written approval from the Department, an 2390 Agreement State, Licensing State, or NRC in a license and uses the material in 2391 accordance with the regulations and specific conditions that the Department, 2392 Agreement State, Licensing State, or NRC considers necessary for the medical 2393 use of the material.
2394 7.63 Five Year Inspection.Full-inspection servicing for teletherapy and gamma stereotactic 2395 radiosurgery units 2396 7.63.1 A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully 2397 inspected and serviced during source replacement or at intervals not to exceed 5 years, 2398 whichever comes first, to assure proper functioning of the source exposure mechanism. A 2399 licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully 2400 inspected and serviced during each source replacement to assure proper functioning of 2401 the source exposure mechanism and other safety components. The interval between each 2402 full inspection servicing shall not exceed 5 years for each teletherapy unit and shall not 2403 exceed 7 years for each gamma stereotactic radiosurgery unit.
2404 Commented [JSJ169]: This section has been formatted/aligned for appearance. Alignment corrections may not appear as strike out/changed text.
Clarifying language added for consistency with 10 CFR 35.2645(a).
Commented [JSJ170]: This provision parallels the requirement of 10 CFR 35.2645(c).
Commented [JJ171]: Updated for consistency with changes to 10 CFR 35.655(a).
The title was changed to reflect the revised/extended servicing interval (from 5 years to 7 years) for gamma stereotactic radiosurgery (GSR) units.
In consideration of the 6 month periodic maintenance interval and due to the high cost of source replacement for GSR units, stakeholders (nationally) requested a change in this servicing interval.
NRC Compatibility H&S RATS 2018-1 Document 1 HRG Page 90 of 138
7.63.2 This inspection and servicing shall only be performed by persons specifically licensed to do so by 2405 the Department, another Agreement State, a Licensing State, or the NRC.
2406 Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.
2407 7.63.3 A licensee shall keepmaintain a record of the full-inspection and servicing for teletherapy and 2408 gamma stereotactic radiosurgery units required by 7.63 for the duration of the licenseuse of 2409 the unit.
The record shall contain:
2410 7.63.4 The record required by 7.63.3 must contain:
2411 7.63.34.1 The inspector's radioactive materials license number; 2412 7.63.34.2 The date of inspection; 2413 7.63.34.3 The manufacturer's name and model number and serial number of both the 2414 treatment unit and source; 2415 7.63.3.4 A list of components inspected and serviced; 2416 7.63.3.54.4 A list of components inspected and serviced, and the type of service; and 2417 7.63.3.6 A list of components replaced; and 2418 7.63.3.7 The signature of the inspector.
2419 7.63.4.5 The signature of the inspector.
2420 7.64 Therapy-related computer systems.
2421 7.64.1 The licensee shall perform acceptance testing on the treatment planning system in 2422 accordance with published protocols accepted by nationally recognized bodies.
2423 7.64.2 At a minimum, the acceptance testing required by 7.64.1 shall include, as applicable, 2424 verification of:
2425 7.64.2.1 The source-specific input parameters required by the dose calculation 2426 algorithm; 2427 7.64.2.2 The accuracy of dose, dwell time, and treatment time calculations at 2428 representative points; 2429 7.64.2.3 The accuracy of isodose plots and graphic displays; and 2430 7.64.2.4 The accuracy of the software used to determine radioactive source 2431 positions from radiographic images.
2432 7.64.2.5 The accuracy of electronic transfer of the treatment delivery parameters to 2433 the treatment delivery unit from the treatment planning system.
2434 Section I - Recentness of training.
2435 7.65 The training and experience specified in 7.65.1 through 7.65.6 must have been obtained 2436 within the 7 years preceding the date of application or the individual must have had related 2437 continuing education and experience since the required training and experience was 2438 completed.
2439 Commented [JSJ172]: Updated for consistency with 10 CFR 35.2655.
NRC Compatibility D CROSS
REFERENCE:
7.63 = 10 CFR 35.655 Commented [JSJ173]: Prior provisions 7.63.3.4 and 7.63.3.5 are replaced by an equivalent requirement in 7.63.4.4.
Commented [JSJ174]: There is no equivalent provision in 10 CFR 35.
Commented [JSJ175]: Prior provision 7.63.3.7 is replaced by an equivalent requirement in 7.63.4.5.
Commented [JSJ176]: Provision added for consistency with 10 CFR 35.657.
With the exception of 7.64.2.5, these requirements are equivalent to those already found in the current 7.47 found in Section G for manual brachytherapy. They are added (repeated) here for consistency with the format of the federal rule which is best suited to the computer based systems used with the afterloader, teletherapy, and GSR devices of Section H. The provision of 10 CFR 35.657(e) is incorporated in 7.64.2.5 as it previously omitted.
This is not a RATS item.
Commented [JSJ177]: This provision parallels requirements in 10 CFR Part 35.59, and replaces and consolidates similar existing requirements that are repeated in the appendices of the current (in effect) rule (now proposed for deletion).
Document 1 HRG Page 91 of 138
2440 7.65.1 Section B,Section I, Appendix 7A, 7B, 7C, and 7P.
2441 7.65.2 Section D, Appendix 7D, and 7E.
2442 7.65.3 Section E, Appendix 7F, 7G, 7H and 7I.
2443 7.65.4 Section F, Appendix 7J.
2444 7.65.5 Section G, Appendix 7K and Appendix 7L.
2445 7.65.6 Section H, and Appendix 7M.
2446 2447 Commented [JSJ178]: Section B refers to provisions 7.7 through 7.14 (inclusive) pertaining to general administrative requirements which parallels subpart B of 10 CFR 35, with the following exceptions: due to formatting differences and limitations, Section B of Part 7 does not directly include 7.65 (Section I) or specific references to Appendix 7A, 7B, 7C, and 7P. Therefore, these provisions are explicitly listed.
Commented [JSJ179]: Section D refers to provisions 7.30 through 7.34 (inclusive) pertaining to unsealed radioactive material NOT requiring a written directive which parallels subpart D of 10 CFR 35.
Commented [JSJ180]: Section E refers to provisions 7.36 through 7.38 (inclusive) pertaining to unsealed radioactive material requiring a written directive which parallels subpart E of 10 CFR 35.
Commented [JSJ181]: Section F refers to provision 7.40 for sealed sources for diagnosis which parallels subpart G of 10 CFR 35.
Commented [JSJ182]: Section G refers to provisions 7.41 through 7.47 (inclusive) pertaining to manual brachytherapy which parallels subpart F of 10 CFR 35.
Commented [JSJ183]: Section H refers to 7.48 through 7.63, and Appendix 7M which parallels subpart H of 10 CFR
- 35.
Document 1 HRG Page 92 of 138
PART 7, APPENDIX 7A: TRAINING FOR RADIATION SAFETY OFFICER (RSO) AND ASSOCIATE 2448 RADIATION SAFETY OFFICER (ARSO) 2449 TheExcept as provided in Appendix 7P, the licensee shall require thean individual fulfilling the 2450 responsibilities of the Radiation Safety Officer (RSO) or an individual assigned duties and tasks as an 2451 Associate Radiation Safety Officer (ARSO) as provided in 7.7 to be an individual who:
2452 7A1 Is certified by a specialty board whose certification process has been recognized by NRC or an 2453 Agreement State and who meets the requirements in paragraphs 7A4 and 7A5 of this Appendix.
2454 NRC recognized specialty boards are posted on the NRC website at 2455 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. Is certified by a 2456 specialty board whose certification process has been recognized by the NRC or an 2457 Agreement State and who meets the requirements in 7A4 of this Appendix. The names of 2458 board certifications that have been recognized by the NRC or an Agreement State are 2459 posted on the NRCs Medical Uses Licensee Toolkit Web page. To have its certification 2460 process recognized, a specialty board shall require all candidates for certification to:
2461 To have its certification process recognized, a specialty board shall require all candidates for certification 2462 to:
2463 7A1.1 2464 (1)
Hold a bachelor's or graduate degree from an accredited college or university in 2465 physical science or engineering or biological science with a minimum of 20 2466 college credits in physical science; 2467 and 2468 (2)
Have 5 or more years of professional experience in health physics (graduate 2469 training may be substituted for no more than 2 years of the required 2470 experience) including at least 3 years in applied health physics;, provided:
2471 (a)
At least 3 years are in applied health physics; 2472 and 2473 (b)
Graduate training may substitute for no more than 2 years of the required 2474 5 years of experience; 2475 and 2476 (3)
Pass an examination administered by diplomates of the specialty board, which 2477 evaluates knowledge and competence in radiation physics and instrumentation, 2478 radiation protection, mathematics pertaining to the use and measurement of 2479 radioactivity, radiation biology, and radiation dosimetry; 2480 or 2481 7A1.2 2482 (1)
Hold a master's or doctor's degree in physics, medical physics, other physical 2483 science, engineering, or applied mathematics from an accredited college or 2484 university; 2485 and 2486 Commented [JJ184]: For final publication, insert a page break to ensure each new appendices begins at the top of the page.
Commented [JJ185]: Introductory text modified, consistent with 2018 amendments to 10 CFR 35.50.
The changes incorporate the requirements associated with the new Associate Radiation Safety Officer terminology.
NRC Compatibility B NRC RATS 2018-1 NOTE: The changes in this and in other subsequent appendices are similar and include the following:
- 1. Removal of the specific NRC web address (where the accepted board certifications are located) and use a more generic website reference.
- 2. Relocation of the recentness of training requirements to Section 7.65.
- 3. Relocation (and revision of) the requirements for an experienced individual to the new (proposed) Appendix 7P.
Commented [JJ186]: Wording and format updated for consistency and alignment of 10 CFR 35.50(a).
There is no change to the requirement. Only the formatting is changed to better align with CFR.
Document 1 HRG Page 93 of 138
(2)
Have 2 years of full-time practical training and/or supervised experience in 2487 medical physics: that is:
2488 (a)
Under the supervision of a medical physicist who is certified in medical 2489 physics by a specialty board recognized by an Agreement State or NRC; 2490 or 2491 (b)
In clinical nuclear medicine facilities providing diagnostic and / or 2492 therapeutic services under the general supervision direction of 2493 physicians who meet the requirements for Authorized Users in 2494 7A7Appendix 7P, Appendix 7E or Appendix 7F; 2495 and 2496 (3)
Pass an examination administered by diplomates of the specialty board, that 2497 assesses knowledge and competence in clinical diagnostic radiological or 2498 nuclear medicine physics and in radiation safety.
2499 or 2500 7A2 Has satisfied the following criteria:
2501 7A2.1 Has completed a structured educational program consisting of both:
2502 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
2503 (a)
Radiation physics and instrumentation; 2504 (b)
Radiation protection; 2505 (c)
Mathematics pertaining to the use and measurement of radioactivity; 2506 (d)
Radiation biology; and 2507 (e)
Radiation dosimetry; 2508 and 2509 (2) 1One year of full-time radiation safety experience, under the supervision of the 2510 individual identified as anthe RSO or Alternate RSO, on an NRC or an 2511 Agreement State license or NRC license or permit issued by a NRC master 2512 material licensee that authorizes similar type(s) of use(s) of radioactive material.,
2513 involving the following: An Associate Radiation Safety Officer may provide 2514 supervision for those areas for which the Associate Radiation Safety 2515 Officer is authorized on a NRC or an Agreement State license or permit 2516 issued by a NRC master material licensee. The full-time radiation safety 2517 experience must involve the following:
2518 (a)
Shipping, receiving, and performing related radiation surveys; 2519 (b)
Using and performing checks for proper operation of dose 2520 calibratorsinstruments used to determine the activity of dosages, 2521 survey meters, and, if appropriate, instruments used to measure 2522 radionuclides; 2523 (c)
Securing and controlling radioactive material; 2524 Commented [JSJ187]: This provision is revised for consistency with the 2018 amendments to 10 CFR 35.50(b)(1)(ii).
With the introduction of the concept of an Associate RSO (as defined in Section 7.2) arising from the 2018 amendments to Part 35, the revised language in this requirement clarifies that for an individual who is in the process of becoming a RSO for a medical licensee, the experience gained while under the supervision of an Associate RSO is acceptable for those areas for which the Associate RSO is authorized on the license.
Document 1 HRG Page 94 of 138
(d)
Using administrative controls to avoid mistakes in the administration of 2525 radioactive material; 2526 (e)
Using procedures to prevent or minimize radioactive contamination and 2527 using proper decontamination procedures; 2528 (f)
Using emergency procedures to control radioactive material; and 2529 (g)
Disposing of radioactive material; 2530 and 2531 7A2.2 This individual must obtain a written attestation, signed by a preceptor RSO or 2532 ARSO who has experience with the radiation safety aspects of similar types of use 2533 of radioactive material for which the individual is seeking approval as a RSO or an 2534 ARSO. The written attestation must state that the individual has satisfactorily 2535 completed the requirements in 7A2.1 and 7A4 of Appendix 7A and is able to 2536 independently fulfill the radiation safety related duties as a RSO or as an ARSO for 2537 a medical use license; 2538 or 2539 7A3 Meets the following requirements:
2540 7A3.1 Is a medical physicist who has been certified by a specialty board whose certification 2541 process has been recognized by the NRC or an Agreement State under Appendix 7B, 2542 Section 7B1, and has experience inwith the radiation safety aspects for of similar types 2543 of use of radioactive material for which the licensee is seekingseeks the approval of the 2544 individual as Radiation Safety OfficerRSO or an ARSO, and who meets the requirements 2545 in 7A4 and 7A5.
2546 or 2547 7A3.2 Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist 2548 identified on the licensees license and has experience with the radiation safety aspects 2549 of similar types of use of radioactive materials for which the individual has RSO 2550 responsibilities;Is an authorized user, authorized medical physicist, or authorized 2551 nuclear pharmacist identified on a Department, NRC or an Agreement State 2552 license, a permit issued by a NRC master material license, a permit issued by a 2553 NRC or an Agreement State licensee of broad scope, or a permit issued by a NRC 2554 master material broad scope permitee, has experience with the radiation safety 2555 aspects of similar types of use of radioactive material for which the licensee seeks 2556 the approval of the individual as the RSO or ARSO, and meets the requirements in 2557 7A4; 2558 or 2559 7A3.3 Has experience with the radiation safety aspects of the types of use of radioactive 2560 material for which the individual is seeking simultaneous approval both as the 2561 Radiation Safety Officer and the authorized user on the same new medical use 2562 permit issued by a NRC master material license. The individual must also meet the 2563 requirements in 7A4.
2564 and 2565 7A4 Has provided written attestation(s), signed by a preceptor RSO, that the individual has 2566 satisfactorily completed the requirements in 7A5 and in 7A1.1(1) and 7A1.1(2) or 7A1.2(1) and 2567 Commented [JJ188]: 35.50(c)
Commented [JJ189]: 35.50(c)(3).
NRC Compatibility B RATS 2018-1 Document 1 HRG Page 95 of 138
7A1.2(2) or 7A2.1 or 7A3.1 or 7A3.2, and has achieved a level of radiation safety knowledge 2568 sufficient to function independently as an RSO for a medical use licensee; 2569 and 2570 7A57A4 Has training in the radiation safety, regulatory issues, and emergency procedures for the 2571 types(s) of use for which a licensee seeks approval. This training requirement may be satisfied by 2572 completing training that is supervised by an RSO, Alternate RSO, an Associate RSO, authorized 2573 medical physicist, authorized nuclear pharmacist, or authorized user, as appropriate, who is 2574 authorized on an Agreement State or NRC license for the type(s) of use of radioactive material for 2575 which the licensee is seeking approval.
2576 and 2577 7A6 Meets the following recentness of training requirements:
2578 7A6.1 The training and experience required by Appendix 7A shall have been obtained within the 2579 7 years preceding the date of license application or amendment request; 2580 or 2581 7A6.2 The individual must have had related, documented continuing education and experience 2582 since the required training and experience was obtained.
2583 or 2584 7A7 Meets the following requirements for an experienced Radiation Safety Officer:
2585 7A7.1 An individual identified as a Radiation Safety Officer on a license issued by the NRC or 2586 Agreement State, a permit issued under an NRC or Agreement State broad scope 2587 license before October 25, 2005, are not required to comply with the training 2588 requirements of 7A1 through 7A6.7A7.2 Individuals not required to comply with the 2589 training requirements of 7A1 through 7A6 may serve as preceptors for, and supervisors 2590 of, applicants seeking authorization on licenses for the same uses for which these 2591 individuals are authorized.
2592 2593 2594 Commented [JJ190]: This provision is updated for consistency with the 2018 amendment to 10 CFR 35.50(d).
Commented [JJ191]:
Here and in multiple subsequent Appendices, the requirements for recentness of training have been relocated to new provision 7.65 in order to consolidate the requirements in one location in the rule. (The requirements of 7.65 parallel the requirements of 10 CFR 35.59.)
Commented [JJ192]:
Here and in multiple subsequent Appendices, the requirements for an experienced authorized individual is replaced with the requirements contained in (new) Appendix 7P in order to consolidate the requirements in one location.
The requirements of Appendix 7P parallel the requirements of 10 CFR 35.57.
Document 1 HRG Page 96 of 138
PART 7, APPENDIX 7B: TRAINING FOR AN AUTHORIZED MEDICAL PHYSICIST (AMP) 2595 The licensee shall require each authorized medical physicist to be an individual who:Except as 2596 provided in Appendix 7P, the licensee shall require the authorized medical physicist to be an 2597 individual who:
2598 7B1 Is certified by a medical specialty board whose certification process has been recognized by the 2599 NRC or an Agreement State and who meets the requirements in paragraph 7B2.3 and 7B3 of this 2600 Appendix. NRC recognized specialty boards are posted on the NRC website at 2601 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.Is certified by a 2602 specialty board whose certification process has been recognized by the NRC or an 2603 Agreement State and who meets the requirements in 7B3 of this Appendix. The names of 2604 board certifications that have been recognized by the NRC or an Agreement State are 2605 posted on the NRCs Medical Uses Licensee Toolkit Web page. To have its certification 2606 process recognized, a specialty board shall require all candidates for certification to:
2607 7B1.1 To have its certification process recognized, a specialty board shall require all candidates 2608 for certification to:
2609 (1)7B1.1 Hold a master's or doctor's degree in physics, medical physics, other physical 2610 science, engineering, or applied mathematics from an accredited college or university; 2611 and 2612 (2)7B1.2 Have 2 years of full-time practical training and/or supervised experience in 2613 medical physics:
2614 (a1)
Under the supervision of a medical physicist who is certified in medical physics 2615 by a specialty board whose certification process has been recognized under 2616 7B1 by the NRC or an Agreement State or NRC; 2617 or 2618 (b2)
In clinical radiation facilities providing high energy, external beam therapy 2619 (photons and electrons with energies greater than or equal to 1 million electron 2620 volts) and brachytherapy services under the direction of physicians who meet the 2621 requirements for authorized users in 7B5Appendix 7P, Appendix 7K or Appendix 2622 7M; 2623 and 2624 (3)7B1.3 Pass an examination administered by diplomates of the specialty board, that 2625 assesses knowledge and competence in clinical radiation therapy, radiation safety, 2626 calibration, quality assurance, and treatment planning for external beam therapy, 2627 brachytherapy, and stereotactic radiosurgery; 2628 or 2629 7B2 Has satisfied the following criteria:
2630 7B2.1 Holds a master's or doctor's degree in physics, medical physics, other physical science, 2631 engineering, or applied mathematics from an accredited college or university; and has 2632 completed 1 year of full-time training in medical physics and an additional year of 2633 full-time work experience under the supervision of an individual who meets the 2634 requirements for an authorized medical physicist for the type(s) of use for which 2635 the individual is seeking authorization. This training and work experience must be 2636 Commented [JJ193]: For final publication, insert a page break to ensure each new appendices begins at the top of the page.
Commented [JJ194]: Appendix 7B is updated for consistency with the 2018 amendments to 10 CFR 35.51.
NRC RATS 2018-1 NRC Compatibility B Document 1 HRG Page 97 of 138
conducted in clinical radiation facilities that provide high-energy, external beam 2637 therapy (photons and electrons with energies greater than or equal to 1 million 2638 electron volts) and brachytherapy services and must include:
2639 and 2640 7B2.2 Has completed 1 year of full-time training in medical physics and an additional year of 2641 full-time work experience under the supervision of an individual who meets the 2642 requirements for an authorized medical physicist for the type(s) of use for which the 2643 individual is seeking authorization.
2644 (1)
The training and work experience of 7B2.2 must be:
2645 Conducted in clinical radiation facilities that provide high-energy, external beam 2646 therapy (photons or electrons with energies greater than or equal to 1 MeV) and 2647 brachytherapy services and must include:
2648 (a1)
Performing sealed source leak tests and inventories; 2649 (b2)
Performing decay corrections; 2650 (c3)
Performing full calibration and periodic spot checks of external beam treatment 2651 units, stereotactic radiosurgery units, and remote afterloading units as applicable; 2652 and 2653 (d4)
Conducting radiation surveys around external beam treatment units, stereotactic 2654 radiosurgery units, and remote afterloading units as applicable; 2655 and 2656 7B2.32 Has obtained written attestation that the individual has satisfactorily completed the 2657 requirements in: 7B2.1 and 7B3, and is able to independently fulfill the radiation 2658 safety-related duties as an authorized medical physicist for each type of 2659 therapeutic medical unit for which the individual is requesting authorized medical 2660 physicist status. The written attestation must be signed by a preceptor authorized 2661 medical physicist who meets the requirements in Appendix 7B, Appendix 7P, or 2662 equivalent NRC or Agreement State requirements for an authorized medical 2663 physicist for each type of therapeutic medical unit for which the individual is 2664 requesting authorized medical physicist status.
2665 (1) 7B3 and 7B1.1(1) and 7B1.1(2);
2666 or 2667 (2) 7B2 and 7B3; 2668 and 2669 (3)
Has achieved a level of competency sufficient to function independently as an 2670 authorized medical physicist for each type of therapeutic medical unit for which 2671 the individual is requesting authorized medical physicist status. The written 2672 attestation must be signed by a preceptor authorized medical physicist who 2673 meets the requirements in this Appendix (7B), 7B5, or equivalent NRC or 2674 Agreement State requirements for an authorized medical physicist for each type 2675 of therapeutic medical unit for which the individual is requesting authorized 2676 medical physicist status; 2677 Commented [JSJ195]: This provision is replaced by the prior updated provision in 7B2.1 in keeping with the format and flow of 10 CFR 35.51.
Commented [JJ196]: Updated for consistency with 10 CFR 35.51(b)(2).
Document 1 HRG Page 98 of 138
and 2678 7B3 Has met the following requirements:
2679 7B3.1 Has training for the type(s) of use for which authorization is sought that includes:
2680 (1)
Hands-on device operation, 2681 (2)
Safety procedures, 2682 (3)
Clinical use, 2683 and 2684 (4)
The operation of a treatment planning system.
2685 7B3.2 The training required by 7B3.1 may be satisfied by:
2686 (1)
Satisfactorily completing a training program provided by the vendor; 2687 or 2688 Through training supervised by an authorized medical physicist authorized for the type(s) 2689 of use for which the individual is seeking authorization.
2690 7B3 Has training for the type(s) of use for which authorization is sought that includes hands-on 2691 device operation, safety procedures, clinical use, and the operation of a treatment 2692 planning system. This training requirement may be satisfied by satisfactorily completing 2693 either a training program provided by the vendor or by training supervised by an 2694 authorized medical physicist authorized for the type(s) of use for which the individual is 2695 seeking authorization.
2696 7B4 Meets the following recentness of training requirements:
2697 7B4.1 Training and experience required by Appendix 7B shall have been obtained within the 7 2698 years preceding the date of license application or amendment request; 2699 or 2700 7B4.2 The individual must have had related, documented, continuing education and experience 2701 since the required training and experience was obtained.
2702 or 2703 7B5 Meets the following requirements for an experienced authorized medical physicist:
2704 7B5.1 An individual identified as an authorized medical physicist on a license issued by the 2705 NRC or Agreement State, a permit issued under an NRC or Agreement State broad 2706 scope license before October 25, 2005, are not required to comply with the training 2707 requirements of 7B1 through 7B4.
2708 or 2709 2710 7B5.2 An experienced medical physicist who has demonstrated to the Department experience 2711 in the type(s) of use for which the individual is requesting authorized medical physicist 2712 Commented [JSJ197]: This provision is replaced by revised 7B3 (below) to maintain the flow and format of 10 CFR 35.51(c).
The requirements remain the same. Only the numbering and some phrasing has changed.
Document 1 HRG Page 99 of 138
status (and thus need not comply with the specific training and experience requirements 2713 of 7B1 through 7B4):
2714 (1)
Having been certified before October 25, 2005 by the American Board of 2715 Radiology in:
2716 (a)
Therapeutic radiological physics; 2717 (b)
Roentgen ray and gamma ray physics; 2718 (c)
X-ray and radium physics; 2719 or 2720 (d)
Radiological physics; 2721 or 2722 (2)
Having been certified before October 25, 2005 by the American Board of Medical 2723 Physics in radiation oncology physics; 2724 and 2725 (3)
Has sufficient work experience that includes the tasks listed in 7.13.2 and/or 2726 other sections of these regulations related to medical physics, as applicable 2727 (having also satisfied 7B2.1 and being trained in therapeutic radiological 2728 physics).
2729 7B5.3 Individuals not required to comply with the training requirements of 7B1 through 7B4 may 2730 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 2731 for the same uses for which these individuals are authorized.
2732 2733 Document 1 HRG Page 100 of 138
PART 7, APPENDIX 7C: TRAINING FOR AND AUTHORIZED NUCLEAR PHARMACIST (ANP) 2734 The licensee shall require each authorized nuclear pharmacist to be a pharmacist who has a 2735 current active Colorado State Board of Pharmacy license and who:Except as provided in 2736 Appendix 7P, the licensee shall require the authorized nuclear pharmacist to be a pharmacist 2737 who:
2738 7C1 Is certified by a medical specialty board whose certification process has been recognized by the 2739 NRC or an Agreement State and who meets the requirements in paragraph 7C2.2 of this 2740 Appendix. NRC recognized specialty boards are posted on the NRC website at 2741 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.Is certified by a 2742 specialty board whose certification process has been recognized by the NRC or an 2743 Agreement State. The names of board certifications that have been recognized by the NRC 2744 or an Agreement State are posted on the NRCs Medical Uses Licensee Toolkit Web page.
2745 To have its certification process recognized, a specialty board shall require all candidates 2746 for certification to:
2747 7C1.1 To have its certification process recognized, a specialty board shall require all candidates 2748 for certification to:
2749 (1)7C1.1 Have graduated from a pharmacy program accredited by the American Council 2750 on Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy 2751 Graduate Examination Committee (FPGEC) examination; 2752 (2)7C1.2 Hold a current, active license to practice pharmacy; 2753 (3)7C1.3 Provide evidence of having acquired at least 4000 hours0.0463 days <br />1.111 hours <br />0.00661 weeks <br />0.00152 months <br /> of training/experience in 2754 nuclear pharmacy practice. (aAcademic training may be substituted for no more 2755 than 2000 hours0.0231 days <br />0.556 hours <br />0.00331 weeks <br />7.61e-4 months <br /> of the required training and experience);
2756 and 2757 (4)7C1.3 Pass an examination, in nuclear pharmacy administered by diplomates of the 2758 specialty board, whichthat assesses knowledge and competency in 2759 procurement, compounding, quality assurance, dispensing, distribution, health 2760 and safety, radiation safety, provision of information and consultation, monitoring 2761 patient outcomes, and research and development.;
2762 or 2763 7C2 Has satisfied the following criteria:
2764 7C2.1 Has completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> in a structured educational program that includesconsisting of 2765 both:
2766 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
2767 (a)
Radiation physics and instrumentation; 2768 (b)
Radiation protection; 2769 (c)
Mathematics pertaining to the use and measurement of radioactivity; 2770 (d)
Chemistry of radioactive material for medical use; and 2771 (e)
Radiation biology; 2772 Commented [JJ198]: For final publication, insert a page break to ensure each new appendices begins at the top of the page.
Appendix 7C is amended, consistent with the 2018 revisions to 10 CFR 35.55.
NRC RATS 2018-1 NRC Compatibility B Commented [JJ199]: 35.55(b)(1)(i)(A) - (E)
(a) = 35.55(b)(1)(i)(A)
(b) = 35.55(b)(1)(i)(B)
(c) = 35.55(b)(1)(i)(C)
(d) = 35.55(b)(1)(i)(D)
(e) = 35.55(b)(1)(i)(E)
Document 1 HRG Page 101 of 138
and 2773 (2)
Supervised practical experience in nuclear pharmacy involving:
2774 (a)
Shipping, receiving, and performing related radiation surveys; 2775 (b)
Using and performing checks for proper operation of instruments to 2776 determine the activity of dosages, survey meters, and, if appropriate, 2777 instruments used to measure alpha-or beta-emitting radionuclides; 2778 (c)
Calculating, assaying, and safely preparing dosages for patients or 2779 human research subjects; 2780 (d)
Using administrative controls to avoid misadministrationsmedical events 2781 in the administration of radioactive material; 2782 and 2783 (e)
Using procedures to prevent or minimize radioactive contamination and 2784 using proper decontamination procedures; 2785 and 2786 7C2.2 Has provided obtained written attestation(s), signed by a preceptor authorized nuclear 2787 pharmacist, that the individual has satisfactorily completed the requirements in 7C1.1(1),
2788 7C1.1(2), and 7C1.1(3) or 7C27C2.1, and has achieved a level of competency sufficient 2789 to function independently is able to independently fulfill the radiation safety related 2790 duties as an authorized nuclear pharmacist.
2791 and 2792 7C3 Meets the following recentness of training requirements:
2793 7C3.1 The training and experience required by Appendix 7C shall have been obtained within the 2794 7 years preceding the date of license application or amendment request; 2795 or 2796 7C3.2 The individual must have had related, documented, continuing education and experience 2797 since the required training and experience was obtained.
2798 or 2799 7C4 Meets the following requirements for an experienced authorized nuclear pharmacist.
2800 7C4.1 An individual identified as an authorized nuclear pharmacist on a license issued by the 2801 NRC or Agreement State, a permit issued under an NRC or Agreement State broad 2802 scope license before October 25, 2005, are not required to comply with the training 2803 requirements of 7C1 through 7C3.
2804 7C4.2 Individuals not required to comply with the training requirements of 7C1 through 7C3 may 2805 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 2806 for the same uses for which these individuals are authorized.
2807 2808 Commented [JJ200]: 35.55(b)(1)(ii)(A) - (E)
= (a) through (e)
Commented [JJ201]: Updated for consistency with 35.55(b)(2).
NRC Compatibility B RATS 2018-1 Document 1 HRG Page 102 of 138
PART 7, APPENDIX 7D: AUTHORIZED USER TRAINING FOR UPTAKE, DILUTION AND EXCRETION 2809 STUDIES (7.30 USES) 2810 The licensee shall require an authorized user of an unsealed radioactive material for the uses authorized 2811 under 7.30 to be a physician who has a current active State of Colorado license and:Except as provided 2812 in Appendix 7P, the licensee shall require an authorized user of unsealed radioactive material for 2813 the uses authorized under 7.30 to be a physician who:
2814 2815 7D1 Is certified by a medical specialty board whose certification process has been recognized by the 2816 NRC or an Agreement State. and who meets the requirements in paragraph 7D3.2 of this 2817 Appendix. NRC recognized specialty boards are posted on the NRC website at 2818 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The names of board 2819 certifications that have been recognized by the NRC or an Agreement State are posted on 2820 the NRCs Medical Uses Licensee Toolkit web page. To have its certification process 2821 recognized, a specialty board shall require all candidates for certification to:
2822 7D1.1 To have its certification process recognized, a specialty board shall require that all 2823 candidates for certification to:(1)Complete 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of training and experience in basic 2824 radionuclide handling techniques and radiation safety applicable to the medical use of unsealed 2825 radioactive materials for uptake, dilution, and excretion studies as described in 7D3.1(1) through 2826 7D3.1(2)(f);
2827 and 2828 (2)7D1.2 Pass an examination, administered by diplomates of the specialty board, that 2829 assesses knowledge and competence in radiation safety, radionuclide handling, and quality 2830 control.;
2831 or 2832 7D2 Is an authorized user under Appendix 7E, Appendix 7F, or equivalent Agreement State or NRC 2833 requirements; or 7D3 2834 or 2835 7D3 Has satisfied the following criteria:
2836 7D3.1 Has satisfactorily completed 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of training and experience, including a minimum of 2837 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training, in basic radionuclide handling techniques applicable 2838 to the medical use of unsealed radioactive materials for uptake, dilution, and excretion studies.
2839 The training and experience must include:
2840 (1)
Classroom and laboratory training in the following areas:
2841 (a)
Radiation physics and instrumentation; 2842 (b)
Radiation protection; 2843 (c)
Mathematics pertaining to the use and measurement of radioactivity; 2844 (d)
Chemistry of radioactive material for medical use; and 2845 (e)
Radiation biology; 2846 and 2847 (2)
Work experience under the supervision of an authorized user who meets the 2848 requirements of 7D5in Appendix 7P, 7D, 7E, 7F, or equivalent Agreement State 2849 or NRC requirements, involving:
2850 (a)
Ordering, receiving, and unpacking radioactive materials safely and 2851 performing the related radiation surveys; 2852 (b)
Performing quality control procedures on instruments used to determine 2853 the activity of dosages and performing checks for proper operation of 2854 survey meters; 2855 (c)
Calculating, measuring, and safely preparing patient or human research 2856 subject dosages; 2857 Commented [JJ202]:
For final publication, insert a page break to ensure each new appendices begins at the top of the page.
Appendix 7D is updated for consistency with the 2018 amendments to 10 CFR 35.190.
Appendix 7D has been realigned/formatted for consistency with the formatting of other sections of Part 7 and with the flow and format of 10 CFR 35.
Compatibility B NRC RATS 2018-1 Commented [JSJ203]: Section 7D3 has been realigned/formatted for consistency with other sections of Part 7 and the flow and format of 10 CFR 35.
7D3 is an unnumbered header to align with 10 CFR Part 35 structure.
Document 1 HRG Page 103 of 138
(d)
Using administrative controls to prevent a misadministrationmedical 2858 event involving the use of unsealed radioactive material; 2859 (e)
Using procedures to contain spilled radioactive material safely and using 2860 proper decontamination procedures; and 2861 (f)
Administering dosages to patients or human research subjects; 2862 And 2863 7D3.2 Has provided written attestation(s), signed by a preceptor authorized user who meets the 2864 requirements of 7D5, Appendix 7D, Appendix 7E, or Appendix 7F, or equivalent 2865 Agreement State or NRC requirements, that the individual has satisfactorily completed 2866 the requirements in 7D1.1(1) or 7D3.1, and has achieved a level of competency sufficient 2867 to function independently as an authorized user for the medical uses authorized under 2868 7.30.Has obtained written attestation that the individual has satisfactorily 2869 completed the requirements in 7D3.1 and is able to independently fulfill the 2870 radiation safety-related duties as an authorized user for the medical uses 2871 authorized under 7.30. The attestation must be obtained from either:
2872 (1)
A preceptor authorized user who meets the requirements in Appendix 7P, 2873 Appendix 7D, Appendix 7E, or Appendix 7F, or equivalent NRC or 2874 Agreement State requirements; or 2875 (2)
A residency program director who affirms in writing that the attestation 2876 represents the consensus of the residency program faculty where at least 2877 one faculty member is an authorized user who meets the requirements in 2878 Appendix 7P, Appendix 7D, Appendix 7E, Appendix 7F, or equivalent NRC 2879 or Agreement State requirements, and concurs with the attestation 2880 provided by the residency program director. The residency training 2881 program must be approved by the Residency Review Committee of the 2882 Accreditation Council for Graduate Medical Education or the Royal College 2883 of Physicians and Surgeons of Canada or the Council on Postdoctoral 2884 Training of the American Osteopathic Association and must include 2885 training and experience specified in 7D3.1.
2886 and 2887 7D4 Meets the following recentness of training requirements:
2888 7D4.1 The training and experience required by Appendix 7D shall have been obtained within the 2889 7 years preceding the date of license application or amendment request; or 2890 7D4.2 The individual must have had related, documented, continuing education and experience 2891 since the required training and experience was obtained.
2892 or 2893 7D5 Meets the following requirements for an experienced authorized user for 7.30 uses:
2894 7D5.1 An individual identified as an authorized user for the medical use of radioactive material 2895 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 2896 Agreement State broad scope license that authorizes medical use before October 25, 2005, 2897 who perform only those medical uses for which they were authorized on that date are not 2898 required to comply with the training requirements of 7D1 through 7D4.
2899 7D5.2 Individuals not required to comply with the training requirements of 7D1 through 7D4 may 2900 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 2901 for the same uses for which these individuals are authorized.
2902 2903 Commented [JSJ204]: Here, and in other appendices governing training requirements for authorized users, the requirements for attestation statements are revised, consistent with the 2018 amendments to 10 CFR 35.
In general, the requirements for a physician to become an authorized user to be named on a license for a specific type of radioactive materials use are through one of three mechanisms:
(1) they are currently a named authorized user on an existing Department, NRC or other agreement state license; OR (2) they are board certified by a board that has been recognized by the Department, NRC or an agreement state for the particular type of use; OR (3) they do not yet meet the requirements of (1) or (2) and therefore must demonstrate adequate training and experience through the alternate pathway mechanism and provide a signed preceptor statement.
The proposed language provides some regulatory relief by no longer requiring a preceptor statement for individuals who are board certified by a recognized board.
The revised language of this appendices allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Document 1 HRG Page 104 of 138
PART 7, APPENDIX 7E: AUTHORIZED USER TRAINING FOR IMAGING AND LOCALIZATION 2904 STUDIES (7.32 USES) 2905 The licensee shall require an authorized user of an unsealed radioactive material for the uses 2906 authorized under 7.32 to be a physician who has a current active State of Colorado license 2907 and:Except as provided in Appendix 7P, the licensee shall require an authorized user of unsealed 2908 radioactive material for the uses authorized under 7.32 to be a physician who:
2909 7E1 Is certified by a medical specialty board whose certification process has been recognized by the 2910 NRC or an Agreement State and who meets the requirements in paragraph 7E3.2 of this 2911 Appendix. NRC recognized specialty boards are posted on the NRC website at 2912 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. Is certified by a 2913 medical specialty board whose certification process has been recognized by the NRC or 2914 an Agreement State. The names of board certifications that have been recognized by the 2915 NRC or an Agreement State are posted on the NRC's Medical Uses Licensee Toolkit web 2916 page. To have its certification process recognized, a specialty board shall require all 2917 candidates for certification to:
2918 7E1.1 To have its certification process recognized, a specialty board shall require all candidates 2919 for certification to:
2920 (1) 2921 7E1.1 Complete 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience in basic radionuclide handling techniques 2922 and radiation safety applicable to the medical use of unsealed radioactive materials for 2923 imaging and localization studies as described in 7E3.1(1) through 7E3.1(2)(g);
2924 and 2925 (2) 2926 7E1.2 Pass an examination, administered by diplomates of the specialty board, which assesses 2927 knowledge and competence in radiation safety, radionuclide handling, and quality control; 2928 or 2929 7E2 Is an authorized user under Appendix 7F and meets the requirements in 7E3.1(2)(g), or 2930 equivalent Agreement State or NRC requirements; 2931 or 2932 7E3 Has satisfied the following criteria:
2933 7E3.1 Has satisfactorily completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, including a minimum of 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom 2934 and laboratory training in basic radionuclide handling techniques applicable to the 2935 medical use of unsealed radioactive materials for imaging and localization studies. The 2936 training and experience must include at a minimum:
2937 (1)
Classroom and laboratory training in the following areas:
2938 (a)
Radiation physics and instrumentation; 2939 (b)
Radiation protection; 2940 (c)
Mathematics pertaining to the use and measurement of radioactivity; 2941 Commented [JJ205]: For final publication, insert a page break such that each appendix begins on a new page.
This appendix is updated for format and content, consistent with the 2018 amendments to 10 CFR 35.290.
Document 1 HRG Page 105 of 138
(d)
Chemistry of radioactive material for medical use; and 2942 (e)
Radiation biology; 2943 and 2944 (2)
Work experience under the supervision of an authorized user who meets the 2945 requirements of 7E5, 7E, or 7F and 7E3.1(2)(g), or equivalent Agreement State 2946 or NRC requirements, involving:
2947 2948 (2)
Work experience, under the supervision of an authorized user who meets 2949 the requirements in Appendix 7P, 7E, or 7F and 7E3.1(2)(g), or equivalent 2950 NRC or Agreement State requirements. An authorized nuclear pharmacist 2951 who meets the requirements in Appendix 7C or Appendix 7P may provide 2952 the supervised work experience for 7E3.1(2)(g). Work experience must 2953 involve:
2954 (a)
Ordering, receiving, and unpacking radioactive materials safely and 2955 performing the related radiation surveys; 2956 (b)
Performing quality control procedures on instruments used to determine 2957 the activity of dosages and performing checks for proper operation of 2958 survey meters; 2959 (c)
Calculating, measuring, and safely preparing patient or human research 2960 subject dosages; 2961 (d)
Using administrative controls to prevent a misadministrationmedical 2962 event involving the use of unsealed radioactive material; 2963 (e)
Using procedures to safely contain spilled radioactive material safely 2964 and using proper decontamination procedures; and 2965 (f)
Administering dosages to patients or human research subjects; and 2966 (g)
Eluting generator systems appropriate for preparation of radioactive 2967 drugs for imaging and localization studies, measuring and testing the 2968 eluate for radiochemical purity, and processing the eluate with reagent 2969 kits to prepare labeled radioactive drugs; 2970 and 2971 7E3.2 Has provided written attestation(s), signed by a preceptor authorized user who meets the 2972 requirements of 7E5, Appendix 7E, or Appendix 7F and 7E3.1(2)(g), or equivalent 2973 Agreement State or NRC requirements, that the individual has satisfactorily completed 2974 the requirements in 7E1.1(1) or 7E3, and has achieved a level of competency sufficient to 2975 function independently as an authorized user for the medical uses authorized under 7.30 2976 and 7.32. Has obtained written attestation that the individual has satisfactorily 2977 completed the requirements in 7E3.1 and is able to independently fulfill the 2978 radiation safety-related duties as an authorized user for the medical uses 2979 authorized under 7.30 and 7.32. The attestation must be obtained from either:
2980 2981 (1)
A preceptor authorized user who meets the requirements in Appendix 7P, 2982 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement State 2983 requirements; 2984 2985 or 2986 2987 Document 1 HRG Page 106 of 138
(2)
A residency program director who affirms in writing that the attestation 2988 represents the consensus of the residency program faculty where at least 2989 one faculty member is an authorized user who meets the requirements in 2990 Appendix 7P, 7E, or 7F and 7E3.1(2)(g), or equivalent NRC or Agreement 2991 State requirements, and concurs with the attestation provided by the 2992 residency program director. The residency training program must be 2993 approved by the Residency Review Committee of the Accreditation Council 2994 for Graduate Medical Education or the Royal College of Physicians and 2995 Surgeons of Canada or the Council on Postdoctoral Training of the 2996 American Osteopathic Association and must include training and 2997 experience specified in 7E3.1.
2998 and 2999 7E4 Meets the following recentness of training requirements:
3000 7E4.1 The training and experience required by Appendix 7E shall have been obtained within the 3001 7 years preceding the date of license application or amendment request; 3002 or 3003 7E4.2 The individual must have had related, documented, continuing education and experience 3004 since the required training and experience was obtained.
3005 or 3006 7E5 Meets the following requirements for an experienced authorized user for 7.32 uses:
3007 7E5.1 An individual identified as an authorized user for the medical use of radioactive material 3008 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3009 Agreement State broad scope license that authorizes medical use before October 25, 3010 2005, who perform only those medical uses for which they were authorized on that date 3011 are not required to comply with the training requirements of 7E1 through 7E4.7E5.2 3012 Individuals not required to comply with the training requirements of 7E1 through 7E4 may 3013 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3014 for the same uses for which these individuals are authorized.
3015 3016 3017 Commented [JSJ206]: The requirements for attestation statements are revised, consistent with the 2018 amendments to 10 CFR 35.
The revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Commented [JSJ207]: Requirements for recentness of training is now addressed in 7.65 Commented [JSJ208]: Training for experienced individuals is now addressed in Appendix 7P.
Document 1 HRG Page 107 of 138
PART 7, APPENDIX 7F: AUTHORIZED USER TRAINING FOR DIAGNOSTIC OR THERAPEUTIC USE 3018 OF UNSEALED RADIOACTIVE MATERIAL REQUIRING FOR WHICH A WRITTEN DIRECTIVE IS 3019 REQUIRED (7.36.2 USES) 3020 3021 The licensee shall require an authorized user of an unsealed radioactive material for the uses 3022 authorized under 7.36.2 to be a physician who has a current active State of Colorado license and:
3023 Except as provided in Appendix 7P, the licensee shall require an authorized user of unsealed 3024 radioactive material for the uses authorized under 7.36 to be a physician who:
3025 7F1 Is certified by a medical specialty board whose certification process has been recognized by the 3026 NRC or an Agreement State and who meets the requirements in paragraph 7F2.1(2)(f) and 7F2.2 3027 of this Appendix. NRC recognized specialty boards are posted on the NRC website at 3028 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
3029 3030 7F1 Is certified by a medical specialty board whose certification process has been recognized 3031 by the NRC or an Agreement State and who meets the requirements in 7F2.1(2)(f). The 3032 names of board certifications that have been recognized by the NRC or an Agreement 3033 State are posted on the NRC's Medical Uses Licensee Toolkit web page. To be recognized, 3034 a specialty board shall require all candidates for certification to:
3035 7F1.1 To have its certification process recognized, a specialty board shall require all candidates 3036 for certification to:
3037 (1)
Successfully complete residency training in a radiation therapy or nuclear medicine 3038 training program or a program in a related medical specialty. These residency training 3039 programs must include 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience as described in 7F2.1(1) 3040 through 7F2.1(2)(e). Eligible training programs must be approved by the Residency 3041 Review Committee of the Accreditation Council for Graduate Medical Education, the 3042 Royal College of Physicians and Surgeons of Canada, or the Committee on Post-3043 GraduateCouncil on Postdoctoral Training of the American Osteopathic Association; 3044 and 3045 (2)7F1.2 Pass an examination, administered by diplomates of the specialty board, which 3046 tests knowledge and competence in radiation safety, radionuclide handling, quality 3047 assurance, and clinical use of unsealed radioactive material for which a written directive 3048 is required; 3049 or 3050 7F2 Has satisfied the following criteria:
3051 7F2.1 Has satisfactorily completed 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> of training and experience, including a minimum 3052 of 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training, in basic radionuclide handling 3053 techniques applicable to the medical use of unsealed radioactive material requiring a 3054 written directive. The training and experience must include:
3055 (1)
Classroom and laboratory training in the following areas:
3056 (a)
Radiation physics and instrumentation; 3057 (b)
Radiation protection; 3058 (c)
Mathematics pertaining to the use and measurement of radioactivity; 3059 (d)
Chemistry of radioactive material for medical use; and 3060 Commented [JJ209]: For final publication, insert a page break such that each appendix begins on a new page.
Changes to this appendix are based on the 2018 amendments to 10 CFR 35.390.
NRC RATS 2018-1 All of 10 CFR 35.390 is NRC compatibility B Commented [JSJ210]:
Consistent with federal rule, this provision is amended to eliminate the requirement for a preceptor statement for individuals who have a board certification identified on NRCs medical toolkit web page for the applicable use. The board certification combined with the recentness of training requirements (found in 7.65) are deemed acceptable to demonstrate adequate training and experience for regulatory purposes.
Commented [JSJ211]:
Revised to use the correct terminology for the residency approval organization of the American Osteopathic Association.
Commented [JSJ212]: Clarifying wording added for consistency with 10 CFR Part 35.390(b)(1).
Ref: NRC Letter 02/20/2020 Document 1 HRG Page 108 of 138
(e)
Radiation biology; 3061 and 3062 (2)
Work experience, under the supervision of an authorized user who meets the 3063 requirements of 7F4Appendix 7P, or 7F, or equivalent Agreement State or NRC 3064 requirements. A supervising authorized user, who meets the requirements in 3065 7F2.1, must also have experience in administering dosages in the same dosage 3066 category or categories (i.e., 7F2.1(2)(f)) as the individual requesting authorized 3067 user status. The work experience must involve:
3068 (a)
Ordering, receiving, and unpacking radioactive materials safely and 3069 performing the related radiation surveys; 3070 (b)
Performing quality control procedures on instruments used to determine 3071 the activity of dosages and performing checks for proper operation of 3072 survey meters; 3073 (c)
Calculating, measuring, and safely preparing patient or human research 3074 subject dosages; 3075 (d)
Using administrative controls to prevent a misadministrationmedical 3076 event involving the use of unsealed radioactive material; 3077 (e)
Using procedures to contain spilled radioactive material safely and using 3078 proper decontamination procedures; 3079 and 3080 (f)
Administering dosages of radioactive drugs to patients or human 3081 research subjects involving a minimum of 3 cases in each of the 3082 following categories for which the individual is requesting authorized user 3083 status:Administering dosages of radioactive drugs to patients or 3084 human research subjects from the three categories in 7F2.1(2)(f).
3085 Radioactive drugs containing radionuclides in categories not 3086 included in 7F2.1(2)(f) are regulated under 7.62. This work 3087 experience must involve a minimum of three cases in each of the 3088 following categories for which the individual is requesting 3089 authorized user status:
3090 (i)
Oral administration of less than or equal to 1.22 3091 GBqgigabecquerels (33 mCimillicuries) of Nasodium iodide I-3092 131, for which a written directive is required; 3093 (ii)
Oral administration of greater than 1.22 GBq (33 mCi) of Na I-3094 131 for which a written directive is required [experience with at 3095 least 3 cases in 7F2.1(2)(f)(ii) also satisfies the requirement in 3096 category 7F2.1(2)(f)(i)];Oral administration of greater than 3097 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;2 3098 (iii)
Parenteral administration of any radioactive drug that contains 3099 a radionuclide that is primarily used for its electron 3100 emission, beta emitterradiation characteristics, alpha 3101 radiation characteristics, or a photon-emitting radionuclide with 3102 a photon energy less than 150 keV, for which a written directive 3103 is required; 3104 Commented [JJ213]: Updated for consistency with 10 CFR 35.390(b)(1)(ii)(G).
NRC Compatibility B Commented [JSJ214]: Note that footnote 2 is associated with this provision.
Document 1 HRG Page 109 of 138
and/or 3105 (iv)
Parenteral administration of any other radionuclide for which a 3106 written directive is required; 3107 and 3108 7F2.2 Has provided written attestation(s), that the individual has satisfactorily completed the 3109 requirements in 7F1.1(1) and 7F2.1(2)(f) or 7F2.1, and has achieved a level of 3110 competency sufficient to function independently as an authorized user for the medical 3111 uses authorized under 7.36. The written attestation must be signed by a preceptor 3112 authorized user who:Has obtained written attestation that the individual has 3113 satisfactorily completed the requirements in 7F2.1 and is able to independently 3114 fulfill the radiation safety-related duties as an authorized user for the medical uses 3115 authorized under 7.36. The attestation must be obtained from either:
3116 (1)
Meets the requirements in 7F4, Appendix 7F, or equivalent NRC or Agreement 3117 State requirements; andA preceptor authorized user who meets the 3118 requirements in 7P, 7F, or equivalent Agreement State requirements and 3119 has experience in administering dosages in the same dosage category or 3120 categories as the individual requesting authorized user status; or 3121 (2)
The preceptor authorized user, who meets the requirements in 7F2.1 must have 3122 experience in administering dosages in the same dosage category or categories 3123 (i.e., 7F2.1(2)(f)) as the individual requesting authorized user status.A residency 3124 program director who affirms in writing that the attestation represents the 3125 consensus of the residency program faculty where at least one faculty 3126 member is an authorized user who meets the requirements in 7P, 7F, or 3127 equivalent Agreement State or NRC requirements, has experience in 3128 administering dosages in the same dosage category or categories as the 3129 individual requesting authorized user status, and concurs with the 3130 attestation provided by the residency program director. The residency 3131 training program must be approved by the Residency Review Committee of 3132 the Accreditation Council for Graduate Medical Education or the Royal 3133 College of Physicians and Surgeons of Canada or the Council on 3134 Postdoctoral Training of the American Osteopathic Association and must 3135 include training and experience specified in 7F2.1.
3136 3137 2 Experience with at least three cases in Category 7F2.1(2)(f)(ii) also satisfies the requirement in 3138 Category 7F2.1(2)(f)(i).
3139 and 3140 7F3 Meets the following recentness of training requirements:
3141 7F3.1 The training and experience required by Appendix 7F shall have been obtained: within 3142 the 7 years preceding the date of license application or amendment request; 3143 or 3144 7F3.2 The individual must have had related, documented, continuing education and experience 3145 since the required training and experience was obtained.
3146 or 3147 7F4 Meets the following requirements for an experienced authorized user for 7.36.2 uses:
3148 Commented [JSJ215]: This provision is revised, based on the 2018 amendments to 10 CFR 35.390(b)(2)(i) and replaces the language in the current 7F2.2(2).
The previously referenced requirements of 7F4 are now addressed in Appendix 7P.
The revised provision clarifies that the preceptor must have experience administering materials in the same categories as the individual requesting authorization. This provision would apply to an individual who may be an authorized user named on a license for other types of use, but would like obtain authorization in 7F.
Commented [JSJ216]: This is a new provision based on the 2018 amendments to 10 CFR 35.390(b)(2)(ii).
For recent graduates of medical training programs, the revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Commented [JSJ217]:
This provision has been replaced by 7.65, which parallels the requirements of 10 CFR 35.59.
Commented [JSJ218]: This provision has been replaced by Appendix 7P, consistent with the format of 10 CFR 35.390.
Document 1 HRG Page 110 of 138
7F4.1 An individual identified as an authorized user for the medical use of radioactive material 3149 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3150 Agreement State broad scope license that authorizes medical use before October 25, 3151 2005, who perform only those medical uses for which they were authorized on that date 3152 are not required to comply with the training requirements of 7F1 through 7F3.
3153 7F4.2 Individuals not required to comply with the training requirements of 7F1 through 7F3 may 3154 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3155 for the same uses for which these individuals are authorized.
3156 3157 Document 1 HRG Page 111 of 138
PART 7, APPENDIX 7G: AUTHORIZED USER TRAINING FOR THE ORAL ADMINISTRATION OF 3158 SODIUM IODIDE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES LESS THAN OR 3159 EQUAL TO 1.22 Gbqgigabeckquerels I (33 mCimillicuries) (7.36.3 USES) 3160 The licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a 3161 written directive in quantities less than or equal to 1.22 GBq (33 mCi), to be a physician who has a current 3162 active State of Colorado license and:Except as provided in Appendix 7P, the licensee shall require 3163 an authorized user for the oral administration of sodium iodide requiring a written directive in 3164 quantities less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who:
3165 3166 7G1 Is certified by a medical specialty board whose certification process includes all of the 3167 requirements in 7G3.1 and 7G3.1(2)7G3.2 of this Appendix and whose certification process has 3168 been recognized by the NRC or an Agreement State. and who meets the requirements in 3169 paragraph 7G3.1(3) of this Appendix. NRC recognized specialty boards are posted on the NRC 3170 website at http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.The names of 3171 board certifications that have been recognized by the NRC or an Agreement State are 3172 posted on the NRC's Medical Uses Licensee Toolkit web page; 3173 or 3174 7G2 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii),
3175 Appendix 7H, or equivalent NRC or Agreement State requirements; 3176 or 3177 7G3 Has satisfied the following criteria:
3178 7G3.1 Has satisfactorilysuccessfully completed 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, 3179 applicable to the medical use of sodium iodide I-131 for procedures requiring a written 3180 directive.: The training must include:
3181 (1)
The 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 must include:
3182 (a1)
Radiation physics and instrumentation; 3183 (b2)
Radiation protection; 3184 (c3)
Mathematics pertaining to the use and measurement of radioactivity; 3185 (d4)
Chemistry of radioactive material for medical use; and 3186 (e5)
Radiation biology; 3187 and 3188 7G3.2(2)
Has work experience, under the supervision of an authorized user who meets the 3189 requirements of 7G5in Appendix 7P, or Appendix 7F, Appendix 7G, Appendix 7H or 3190 equivalent Agreement State or NRC requirements. A supervising authorized user, who 3191 meets the requirements in 7F2.1, must also have experience in administering dosages as 3192 specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii). as the individual requesting authorized user 3193 status. The work experience must involve:
3194 (a1)
Ordering, receiving, and unpacking radioactive materials safely and performing 3195 the related radiation surveys; 3196 Commented [JJ219]: For final publication, insert a page break such that each appendix begins on a new page.
Appendix 7G is updated for consistency with 10 CFR 35.392.
Commented [JSJ220]:
Consistent with federal rule, this provision is amended to eliminate the requirement for a preceptor statement for individuals who have a board certification identified on NRCs medical toolkit web page for the applicable use. The board certification combined with the recentness of training requirements (found in 7.65) are deemed acceptable to demonstrate adequate training and experience for regulatory purposes.
Document 1 HRG Page 112 of 138
(b2)
Performing quality control procedures on instruments used to determine the 3197 activity of dosages and performing checks for proper operation of survey meters; 3198 (c3)
Calculating, measuring, and safely preparing patient or human research subject 3199 dosages; 3200 (d4)
Using administrative controls to prevent a misadministrationmedical event 3201 involving the use of unsealed radioactive material; 3202 (e5)
Using procedures to contain spilled radioactive material safely and using proper 3203 decontamination procedures; 3204 and 3205 (f6)
Administering dosages to patients or human research subjects that includes at 3206 least 3 cases involving the oral administration of less than or equal to 1.22 3207 gigabecquerels (33 millicuries) of sodium iodide I-131; 3208 and 3209 7G3.3(3)
Has provided written attestation(s), that the individual has completed the 3210 requirements of 7G3.1(1) and 7G3.1(2), and has achieved a level of competency 3211 sufficient to function independently as an authorized user for the medical uses of 3212 unsealed radioactive materials using Na I-131 authorized under 7.36. The written 3213 attestation must be signed by a preceptor authorized user who:Has obtained written 3214 attestation that the individual has satisfactorily completed the requirements in 3215 7G3.1 and 7G3.2, and is able to independently fulfill the radiation safety-related 3216 duties as an authorized user for oral administration of less than or equal to 1.22 3217 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized 3218 under 7.36. The attestation must be obtained from either:
3219 (a1)
A preceptor authorized user who Mmeets the requirements in 7G5Appendix 3220 7P, Appendix 7F, Appendix 7G, or Appendix 7H, or equivalent NRC or 3221 Agreement State requirements and has experience administering dosages as 3222 specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii);
3223 andor 3224 (b)
The preceptor authorized user, who meets the requirements in 7F2.1 must have 3225 experience in administering dosages as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii).
3226 (2)
A residency program director who affirms in writing that the attestation 3227 represents the consensus of the residency program faculty where at least 3228 one faculty member is an authorized user who meets the requirements in 3229 Appendix 7P, Appendix 7F, Appendix 7G, Appendix 7H, or equivalent NRC 3230 or Agreement State requirements, has experience in administering dosages 3231 as specified in 7F2.1(2)(f)(i) or 7F2.1(2)(f)(ii), and concurs with the 3232 attestation provided by the residency program director. The residency 3233 training program must be approved by the Residency Review Committee of 3234 the Accreditation Council for Graduate Medical Education or the Royal 3235 College of Physicians and Surgeons of Canada or the Council on 3236 Postdoctoral Training of the American Osteopathic Association and must 3237 include training and experience specified in 7G3.1 and 7G3.2.
3238 and 3239 7G4 Meets the following recentness of training requirements:
3240 7G4.1 The training and experience required by Appendix 7G shall have been obtained within 3241 the 7 years preceding the date of license application or amendment request; 3242 Commented [JSJ221]:
The revised provision clarifies that the preceptor must have experience administering materials in the same categories as the individual requesting authorization. This provision would apply to an individual who may be an authorized user named on a license for other types of use, but would like obtain authorization for uses under 7G.
Commented [JSJ222]: This provision is new, based on the 2018 amendments to 10 CFR 35.392(c)(3)(ii).
For recent graduates, the revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Document 1 HRG Page 113 of 138
or 3243 7G4.2 The individual must have had related, documented, continuing education and experience 3244 since the required training and experience was obtained.
3245 or 3246 7G5 Meets the following requirements for an experienced authorized user for 7.36.3 uses:
3247 7G5.1 An individual identified as an authorized user for the medical use of radioactive material 3248 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3249 Agreement State broad scope license that authorizes medical use before October 25, 3250 2005, who perform only those medical uses for which they were authorized on that date 3251 are not required to comply with the training requirements of 7G1 through 7G4.
3252 7G5.2 Individuals not required to comply with the training requirements of 7G1 through 7G4 may 3253 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3254 for the same uses for which these individuals are authorized.
3255 3256 Document 1 HRG Page 114 of 138
PART 7, APPENDIX 7H: AUTHORIZED USER TRAINING FOR THE ORAL ADMINISTRATION OF 3257 SODIUM IODIDE I-131 REQUIRING A WRITTEN DIRECTIVE IN QUANTITIES GREATER THAN 1.22 3258 GBqGIGABECQUERELS (33 mCimillicuries) (7.36.4 USES) 3259 The licensee shall require an authorized user for the oral administration of sodium iodide I-131 3260 requiring a written directive in quantities greater than 1.22 GBq (33 mCi), to be a physician who 3261 has a current active State of Colorado license and:Except as provided in Appendix 7P, the 3262 licensee shall require an authorized user for the oral administration of sodium iodide I-131 3263 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a 3264 physician who:
3265 3266 7H1 Is certified by a medical specialty board whose certification process includes all of the 3267 requirements in 7H3.1, and 7H3.1(2)7H3.2 and whose certification has been recognized by the 3268 NRC or an Agreement State., and who meets the requirements in paragraph 7H3.2 of this 3269 Appendix. NRC recognized specialty boards are posted on the NRC website at 3270 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The names of board 3271 certifications that have been recognized by the NRC or an Agreement State are posted on 3272 the NRC's Medical Uses Licensee Toolkit web page; 3273 or 3274 7H2 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(ii), or equivalent NRC or 3275 Agreement State requirements; 3276 or 3277 7H3 Has satisfied the following criteria:
3278 7H3.1 Has satisfactorilysuccessfully completed 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, 3279 applicable to the medical use of sodium iodide I-131 for procedures requiring a written 3280 directive. The training must include:
3281 (1)
The 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 must include:
3282 (a1)
Radiation physics and instrumentation; 3283 (b2)
Radiation protection; 3284 (c3)
Mathematics pertaining to the use and measurement of radioactivity; 3285 (d4)
Chemistry of radioactive material for medical use; and 3286 (e5)
Radiation biology; 3287 and 3288 7H3.2(2)
Has work experience, under the supervision of an authorized user who meets the 3289 requirements ofin 7H5Appendix 7P, Appendix 7F, Appendix 7H or equivalent 3290 Agreement State or NRC requirements. A supervising authorized user, who meets the 3291 requirements in 7F2.17F2, must also have experience in administering dosages as 3292 specified in 7F2.1(2)(f)(ii). The work experience must involve:
3293 (a1)
Ordering, receiving, and unpacking radioactive materials safely and performing 3294 the related radiation surveys; 3295 (b2)
Performing quality control procedures on instruments used to determine the 3296 activity of dosages and performing checks for proper operation of survey meters; 3297 Commented [JJ223]: For final publication, insert a page break such that each appendix begins on a new page.
Appendix 7H is updated for consistency with the format and 2018 updates to 10 CFR 35.394.
Document 1 HRG Page 115 of 138
(c3)
Calculating, measuring, and safely preparing patient or human research subject 3298 dosages; 3299 (d4)
Using administrative controls to prevent a misadministrationmedical event 3300 involving the use of unsealed radioactive material; 3301 (e5)
Using procedures to contain spilled radioactive material safely and using proper 3302 decontamination procedures; 3303 and 3304 (f6)
Administering dosages to patients or human research subjects, that includes at 3305 least 3 cases involving the oral administration of greater than 1.22 3306 gigabecquerels (33 millicuries) of sodium iodide I-131; 3307 andand 3308 7H3.3(3)
Has provided written attestation(s), that the individual has completed the 3309 requirements of 7H3.1(1) and 7H3.1(2), and has achieved a level of competency 3310 sufficient to function independently as an authorized user for the medical uses of 3311 unsealed radioactive materials using Na I-131 in activities greater than 1.22 GBq (33 3312 mCi) authorized under 7.36. The written attestation must be signed by a preceptor 3313 authorized user who:Has obtained written attestation that the individual has 3314 satisfactorily completed the requirements in 7H3.1 and 7H3.2, and is able to 3315 independently fulfill the radiation safety-related duties as an authorized user for 3316 oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium 3317 iodide I-131 for medical uses authorized under 7.36. The attestation must be 3318 obtained from either:
3319 (1)
A preceptor authorized user who Meetsmeets the requirements in 3320 7H5Appendix 7P, Appendix 7F, or Appendix 7H, or equivalent NRC or Agreement State 3321 requirements; and has experience in administering dosages as specified in 3322 7F2.1(2)(f)(ii); or 3323 andand 3324 (2)
The preceptor authorized user, who meets the requirements in 7F2.1 must have 3325 experience in administering dosages as specified in 7F2.1(2)(f)(ii).
3326 (2)
A residency program director who affirms in writing that the attestation 3327 represents the consensus of the residency program faculty where at least 3328 one faculty member is an authorized user who meets the requirements in 3329 Appendix 7P, Appendix 7F, Appendix 7H, or equivalent NRC or Agreement 3330 State requirements, has experience in administering dosages as specified 3331 in F2.1(2)(f)(ii), and concurs with the attestation provided by the residency 3332 program director. The residency training program must be approved by the 3333 Residency Review Committee of the Accreditation Council for Graduate 3334 Medical Education or the Royal College of Physicians and Surgeons of 3335 Canada or the Council on Postdoctoral Training of the American 3336 Osteopathic Association and must include training and experience 3337 specified in 7H3.1 and 7H3.2.
3338 and 3339 7H4 Meets the following recentness of training requirements:
3340 7H4.1 The training and experience required by Appendix 7H shall have been obtained within the 3341 7 years preceding the date of license application or amendment request; 3342 Commented [JSJ224]: This provision is new, based on the 2018 amendments to 10 CFR 35.392(c)(3)(ii).
For recent graduates, the revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Document 1 HRG Page 116 of 138
or 3343 7H4.2 The individual must have had related, documented, continuing education and experience 3344 since the required training and experience was obtained.
3345 or 3346 7H5 Meets the following requirements for an experienced authorized user for 7.36.4 uses:
3347 7H5.1 An individual identified as an authorized user for the medical use of radioactive material 3348 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3349 Agreement State broad scope license that authorizes medical use before October 25, 3350 2005, who perform only those medical uses for which they were authorized on that date 3351 are not required to comply with the training requirements of 7H1 through 7H4.
3352 7H5.2 Individuals not required to comply with the training requirements of 7H1 through 7H4 may 3353 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3354 for the same uses for which these individuals are authorized.
3355 3356 Document 1 HRG Page 117 of 138
PART 7, APPENDIX 7I: AUTHORIZED USER TRAINING FOR THE PARENTERAL ADMINISTRATION 3357 OF UNSEALED RADIOACTIVE MATERIAL REQUIRING A WRITTEN DIRECTIVE (7.36.5 USES) 3358 The licensee shall require an authorized user for parenteral administration of unsealed radioactive 3359 material for which a written directive is required to be a physician who has a current active State 3360 of Colorado license and:
3361 7I1 Except as provided in Appendix 7P, the licensee shall require an authorized user for the 3362 parenteral administration requiring a written directive to be a physician who:
3363 7I1.1 Is an authorized user under Appendix 7F for uses listed in 7F2.1(2)(f)(iii) or 3364 7F2.1(2)(f)(iv), or equivalent NRC or Agreement State requirements; 3365 or 3366 7I1.2 Is an authorized user under Appendix 7K, Appendix 7M, or equivalent NRC or 3367 Agreement State requirements and who meets the requirements in 7I2; 3368 or 3369 7I1.3 Is certified by a medical specialty board whose certification process has been 3370 recognized by the NRC or an Agreement State under Appendix 7K or Appendix 7M, 3371 and who meets the requirements in paragraph 7I2 of this section.
3372 or 3373 7I2 Is an authorized user under Appendix 7K, Appendix 7M, or equivalent NRC or Agreement State 3374 requirements and who meets the requirements in 7I4; 3375 or 3376 7I3 Is certified by a medical specialty board whose certification process has been recognized by the 3377 NRC or an Agreement State under Appendix 7K or Appendix 7M, and who meets the 3378 requirements in paragraph 7I4 of this section.
3379 or 3380 7I4 Has satisfied the following criteria:
3381 7I2 The physician:
3382 7I4.12.1 Has satisfactorilysuccessfully completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory 3383 training, applicable to parenteral administrations listed in 7F2.1(2)(f)(iii)., for which a 3384 written directive is required, of any beta emitter, or any photon-emitting radionuclide with 3385 a photon energy less than 150 keV, and/or parenteral administration of any other 3386 radionuclide for which a written directive is required. The training must include:
3387 (1)
The training must include:
3388 (a)(1)
Radiation physics and instrumentation; 3389 (b)(2)
Radiation protection; 3390 (c)(3)
Mathematics pertaining to the use and measurement of radioactivity; 3391 (d)(4)
Chemistry of radioactive material for medical use; 3392 and 3393 (e)(5)
Radiation biology; 3394 andand 3395 Commented [JJ225]: For final publication, insert a page break such that each appendix begins on a new page.
This appendix is updated for consistency with the 2018 amendments to 10 CFR 35.396.
NRC RATS 2018-1 NRC Compatibility B Commented [JSJ226]: Provision replaced by 7I1.2 above.
Commented [JSJ227]: Provision replaced by 7I1.3 above.
Document 1 HRG Page 118 of 138
(2)7I2.2 Has work experience under the supervision of an authorized user who meets the 3396 requirements of Appendix 7P7I6, Appendix 7F, Appendix 7I, or equivalent Agreement 3397 State or NRC requirements, in the parenteral administrations listed in 7F2.1(2)(f)(iii)., for 3398 which a written directive is required, of any beta emitter, or any photon-emitting 3399 radionuclide with a photon energy less than 150 keV, and/or parenteral administration of 3400 any other radionuclide for which a written directive is required. A supervising authorized 3401 user, who meets the requirements in 7F, must have experience in administering dosages 3402 as specified in 7F2.1(2)(f)(iii) and/or 7F2.1(2)(f)(iv). A supervising authorized user, 3403 who meets the requirements in Appendix 7F, 7I, or equivalent Agreement State or 3404 NRC requirements, must have experience in administering dosages in the same 3405 category or categories as the individual requesting authorized user status. The 3406 work experience must involve:
3407 (a)(1)
Ordering, receiving, and unpacking radioactive materials safely and performing 3408 the related radiation surveys; 3409 (b)(2)
Performing quality control procedures on instruments used to determine the 3410 activity of dosages and performing checks for proper operation of survey meters; 3411 (c)(3)
Calculating, measuring, and safely preparing patient or human research subject 3412 dosages; 3413 (d)(4)
Using administrative controls to prevent a misadministrationmedical event 3414 involving the use of unsealed radioactive material; 3415 (e)(5)
Using procedures to contain spilled radioactive material safely and using proper 3416 decontamination procedures; 3417 and 3418 (f)(6)
Administering dosages to patients or human research subjects that include:
3419 (i)
At at least 3 cases involving the parenteral administrations as specified in 3420 7F2.1(2)(f)(iii), for which a written directive is required, of any beta emitter, or 3421 any photon-emitting radionuclide with a photon energy less than 150 keV; 3422 and/or 3423 (ii)
At least 3 cases involving the parenteral administration of any other radionuclide, 3424 for which a written directive is required; 3425 and 3426 (3)7I2.3 Has providedobtained written attestation(s) that the individual has satisfactorily 3427 completed the requirements in 7I2 or 7I37I2.1 or 7I2.2, and has achieved a level of 3428 competency sufficient to function is able to independently fulfill the radiation safety-3429 related duties as an authorized user for the parenteral administration of unsealed 3430 radioactive materials requiring a written directive. The written attestation must be signed 3431 by a preceptor authorized user who:The attestation must be obtained from either:
3432 (a)
Meets the requirements in 7I6, Appendix F, or Appendix I, or equivalent 3433 NRC or Agreement State requirements; 3434 and 3435 Document 1 HRG Page 119 of 138
(b)
Meets the requirements in Appendix 7F must have experience in 3436 administering dosages as specified in 7F2.1(2)(f)(iii) and/or 3437 7F2.1(2)(f)(iv).
3438 (1)
A preceptor authorized user who meets the requirements in Appendix 7P, 3439 Appendix 7F, 7I, or equivalent Agreement State or NRC requirements. A 3440 preceptor authorized user who meets the requirements in Appendix 7F, 7I, 3441 or equivalent Agreement State or NRC requirements, must have experience 3442 in administering dosages in the same category or categories as the 3443 individuals requesting authorized user status; 3444 or 3445 (2)
A residency program director who affirms in writing that the attestation 3446 represents the consensus of the residency program faculty where at least 3447 one faculty member is an authorized user who meets the requirements in 3448 Appendix 7P, Appendix 7F, Appendix 7I, or equivalent Agreement State or 3449 NRC requirements, has experience in administering dosages in the same 3450 dose category or categories as the individual requesting authorized user 3451 status, and concurs with the attestation provided by the residency program 3452 director. The residency training program must be approved by the 3453 Residency Review Committee of the Accreditation Council for Graduate 3454 Medical Education or the Royal College of Physicians and Surgeons of 3455 Canada or the Council on Postdoctoral Training of the American 3456 Osteopathic Association and must include training and experience 3457 specified in 7I2.1 and 7I2.2.
3458 and 3459 7I5 Meets the following recentness of training requirements:
3460 7I5.1 The training and experience required by Appendix 7I shall have been obtained within the 3461 7 years preceding the date of license application or amendment request; 3462 or 3463 7I5.2 The individual must have had related, documented, continuing education and experience 3464 since the required training and experience was obtained.
3465 or 3466 7I6 Meets the following requirements for an experienced authorized user for 7.36.5 uses:
3467 7I6.1 An individual identified as an authorized user for the medical use of radioactive material 3468 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3469 Agreement State broad scope license that authorizes medical use before October 25, 3470 2005, who perform only those medical uses for which they were authorized on that date 3471 are not required to comply with the training requirements of 7I1 through 7I5.
3472 7I6.2 Individuals not required to comply with the training requirements of 7I1 through 7I5 may 3473 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3474 for the same uses for which these individuals are authorized.
3475 3476 Commented [JSJ228]:
For recent graduates, the revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Commented [JSJ229]: The recentness of training requirements have been relocated to a single location in 7.65.
Commented [JSJ230]: The requirements for an experienced authorized individual have been consolidated in Appendix 7P.
Document 1 HRG Page 120 of 138
PART 7, APPENDIX 7J: AUTHORIZED USER TRAINING FOR USE OF SEALED SOURCES AND 3477 MEDICAL DEVICES FOR DIAGNOSIS (7.40 USES) 3478 The licensee shall require an authorized user of a diagnostic sealed source for use in a device 3479 authorized under 7.40 to be a physician, dentist or podiatrist who has a current active State of 3480 Colorado license and:Except as provided in Appendix 7P, the licensee shall require the authorized 3481 user of a diagnostic sealed source or a device authorized under 7.40 to be a physician, dentist, or 3482 podiatrist who:
3483 7J1 Is certified by a specialty board whose certification process includes all of the requirements in 7J2 3484 and 7J3, and whose certification process has been recognized by the NRC or an Agreement 3485 State.; NRC recognized specialty boards are posted on the NRC website at 3486 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.Is certified by a 3487 specialty board whose certification process includes all of the requirements in 7J3 and 3488 7J4 and whose certification process has been recognized by the NRC or an Agreement 3489 State. The names of board certifications that have been recognized by the NRC or an 3490 Agreement State are posted on the NRCs Medical Uses Licensee Toolkit web page; 3491 or 3492 7J2 Has satisfied the following criteria:Is an authorized user for uses listed in 7.32 or equivalent 3493 NRC or Agreement State requirements; 3494 or 3495 7J2.17J3 Has completed 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> of classroom and laboratory training in basic radionuclide 3496 handling techniques specifically applicable to the use of the device. The training must include 3497 (1)
The training must include:
3498 (a1)
Radiation physics and instrumentation; 3499 (b2)
Radiation protection; 3500 (c3)
Mathematics pertaining to the use and measurement of radioactivity; 3501 (d4)
Radiation biology; 3502 and 3503 7J34 Has completed training in the use of the device for the uses requested.
3504 and 3505 7J4 Meets the following recentness of training requirements:
3506 7J4.1 The training and experience required by Appendix 7J shall have been obtained within the 3507 7 years preceding the date of license application or amendment request; 3508 or 3509 7J4.2 The individual must have had related, documented, continuing education and experience 3510 since the required training and experience was obtained.
3511 or 3512 7J5 Meets the following requirements for an experienced authorized user for 7.40 uses:
3513 7J5.1 An individual identified as an authorized user for the medical use of radioactive material 3514 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3515 Commented [JJ231]: For final publication, insert a page break such that each appendix begins on a new page.
This appendix is updated for consistency with the 2018 amendments to 10 CFR 35.590.
Document 1 HRG Page 121 of 138
Agreement State broad scope license that authorizes medical use before October 25, 3516 2005, who perform only those medical uses for which they were authorized on that date 3517 are not required to comply with the training requirements of 7J1 through 7J4.;
3518 7J5.2 Individuals not required to comply with the training requirements of 7J1 through 7J4 may 3519 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3520 for the same uses for which these individuals are authorized.
3521 3522 Document 1 HRG Page 122 of 138
PART 7, APPENDIX 7K: AUTHORIZED USER TRAINING FOR THE USE OF MANUAL 3523 BRACHYTHERAPY SOURCES (7.42 USES) 3524 The licensee shall require an authorized user of a manual brachytherapy source for the uses 3525 authorized under 7.42 to be a physician who has a current active State of Colorado license 3526 and:Except as provided in Appendix 7P, the licensee shall require an authorized of a manual 3527 brachytherapy source for the uses authorized under 7.42 to be a physician who:
3528 3529 7K1 Is certified by a medical specialty board whose certification process has been recognized by the 3530 NRC or an Agreement State., and who meets the requirements in paragraph 7K2.3 of this 3531 Appendix. NRC recognized specialty boards are posted on the NRC website at 3532 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.The names of board 3533 certifications that have been recognized by the NRC or an Agreement State are posted on 3534 the NRCs Medical Uses Licensee Toolkit web page. To have its certification process 3535 recognized, a specialty board shall require all candidates for certification to:
3536 7K1.1 To have its certification process recognized, a specialty board shall require all candidates for 3537 certification to:
3538 (1)7K1.1 Successfully complete a minimum of 3 years of residency training in a radiation 3539 oncology program approved by the Residency Review Committee of the 3540 Accreditation Council for Graduate Medical Education or the Royal College of 3541 Physicians and Surgeons of Canada or the Committee on Post-GraduateCouncil 3542 on Postdoctoral Training of the American Osteopathic Association; and 3543 and 3544 (2)7K1.2 Pass an examination, administered by diplomates of the specialty board, that 3545 tests knowledge and competence in radiation safety, radionuclide handling, 3546 treatment planning, quality assurance, and clinical use of manual brachytherapy; 3547 or 3548 7K2 Has satisfied the following criteria:
3549 7K2.1 Has satisfactorily completed a structured educational program in basic radionuclide 3550 handling techniques applicable to the medical use of manual brachytherapy sources, that 3551 includes:
3552 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
3553 (a)
Radiation physics and instrumentation; 3554 (b)
Radiation protection; 3555 (c)
Mathematics pertaining to the use and measurement of radioactivity; 3556 (d)
Radiation biology; 3557 and 3558 (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of work experience, under the supervision of an authorized user who 3559 meets the requirements in 7K4Appendix 7P, Appendix 7K, or equivalent NRC or 3560 Agreement State requirements at a medical institutionfacility authorized to use 3561 radioactive materials under 7.42, involving:
3562 (a)
Ordering, receiving, and unpacking radioactive materials safely and 3563 performing the related radiation surveys; 3564 (b)
Checking survey meters for proper operation; 3565 (c)
Preparing, implanting, and removing brachytherapy sources; 3566 Commented [JJ232]: For final publication, insert a page break such that each appendix begins on a new page.
This appendix is updated for consistency with the 2018 amendments to 10 CFR 35.490.
NRC RATS 2018-1 NRC Compatibility B Commented [JSJ233]:
Revised to use the correct terminology for the residency approval organization of the American Osteopathic Association.
Commented [JSJ234]: The change in this provision is updated for consistency with the 2018 amendments to 10 CFR 35.490(b)(1)(ii).
The current term medical institution (as specifically defined in 7.2) unnecessarily limits where the work experience for an authorized user can be obtained. The language is modified to medical facility which will allow physician authorized users additional flexibility.
Document 1 HRG Page 123 of 138
(d)
Maintaining running inventories of material on hand; 3567 (e)
Using administrative controls to prevent a misadministrationmedical 3568 event involving the use of radioactive material; 3569 (f)
Using emergency procedures to control radioactive material; 3570 and 3571 7K2.2 Has completed 3 years of supervised clinical experience in radiation oncology, under an 3572 authorized user who meets the requirements in 7K4Appendix 7P, Appendix 7K, or 3573 equivalent Agreement State or NRC requirements, provided that the experience:
3574 (a)
Isas part of a formal training program approved by the Residency Review Committee for 3575 Radiation Oncology of the Accreditation Council for Graduate Medical Education or the 3576 Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral 3577 Training of the American Osteopathic Association.; This experience may be obtained 3578 concurrently with the supervised work experience required by 7K2.1 3579 and 3580 (b)
May be obtained concurrently with the supervised work experience required by 3581 7K2.1(2).
3582 and 3583 7K2.3 Has provided written attestation(s), signed by a preceptor authorized user who meets the 3584 requirements in 7K4, Appendix 7K, or equivalent Agreement State or NRC requirements, 3585 that the individual has satisfactorily completed the requirements in 7K1.1(1), or 3586 paragraphs 7K2.1 and 7K2.2, and has achieved a level of competency sufficient to 3587 function independently as an authorized user of manual brachytherapy sources for the 3588 medical uses authorized under 7.42.Has obtained written attestation that the 3589 individual has satisfactorily completed the requirements in 7K2.1 and 7K2.2 and is 3590 able to independently fulfill the radiation safety-related duties as an authorized 3591 user of manual brachytherapy sources for the medical uses authorized under 7.42.
3592 The attestation must be obtained from either:
3593 (1)
A preceptor authorized user who meets the requirements in Appendix 7P, 3594 Appendix 7K, or equivalent Agreement State or NRC requirements.
3595 or 3596 (2)
A residency program director who affirms in writing that the attestation 3597 represents the consensus of the residency program faculty where at least 3598 one faculty member is an authorized user who meets the requirements in 3599 Appendix 7P, Appendix 7K, or equivalent Agreement State or NRC 3600 requirements, and concurs with the attestation provided by the residency 3601 program director. The residency training program must be approved by the 3602 Residency Review Committee of the Accreditation Council for Graduate 3603 Medical Education or the Royal College of Physicians and Surgeons of 3604 Canada or the Council on Postdoctoral Training of the American 3605 Osteopathic Association and must include training and experience 3606 specified in 7K2.1 and 7K2.2.
3607 and 3608 7K3 Meets the following recentness of training requirements:
3609 Commented [JSJ235]:
For recent graduates, the revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Document 1 HRG Page 124 of 138
7K3.1 The training and experience required by Appendix 7K shall have been obtained: within 3610 the 7 years preceding the date of license application or amendment request; 3611 or 3612 7K3.2 The individual must have had related, documented, continuing education and experience 3613 since the required training and experience was obtained.
3614 or 3615 7K4 Meets the following requirements for an experienced authorized user for 7.42 uses:
3616 7K4.1 An individual identified as an authorized user for the medical use of radioactive material 3617 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3618 Agreement State broad scope license that authorizes medical use before October 25, 3619 2005, who perform only those medical uses for which they were authorized on that date 3620 are not required to comply with the training requirements of 7K1 through 7K3.
3621 7K4.2 Individuals not required to comply with the training requirements of 7K1 through 7K3 may 3622 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3623 for the same uses for which these individuals are authorized.
3624 3625 Document 1 HRG Page 125 of 138
PART 7, APPENDIX 7L: AUTHORIZED USER TRAINING FOR OPHTHALMIC USE OF STRONTIUM-3626 90 (7.42 USES) 3627 The licensee shall require an authorized user of a Strontium-90 source for ophthalmic radiotherapy 3628 authorized under 7.42 to be a physician who has a current active State of Colorado license and:Except 3629 as provided in Appendix 7P, the licensee shall require the authorized of strontium-90 for 3630 ophthalmic radiotherapy to be a physician who:
3631 7L1 Is an authorized user under Appendix 7K or equivalent NRC or Agreement State requirements; 3632 or 3633 7L2 Has satisfied the following criteria:
3634 7L2.1 Has satisfactorily completed 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 applicable to 3635 the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:
3636 (1)
The training must include:
3637 (a1)
Radiation physics and instrumentation; 3638 (b2)
Radiation protection; 3639 (c3)
Mathematics pertaining to the use and measurement of radioactivity; and 3640 (d4)
Radiation biology; 3641 and 3642 (2)7L2.2 Supervised clinical training in ophthalmic radiotherapy under the supervision of 3643 an authorized user at a medical institution, clinic, or private practice that includes the use 3644 of strontium-90 for the ophthalmic treatment of five individuals,. This supervised clinical 3645 training must involve:
3646 (a1)
Examination of each individual to be treated; 3647 (b2)
Calculation of the dose to be administered; 3648 (c3)
Administration of the dose; and 3649 (d4)
Follow-up and review of each individual's case history; 3650 and 3651 (3)7L3.3 Has providedobtained written attestation(s), signed by a preceptor authorized 3652 user who meets the requirements in 7L4Appendix 7P, Appendix 7K, Appendix 7L, or 3653 equivalent NRC or Agreement State requirements, that the individual has satisfactorily 3654 completed the requirements of 7L27L2.1 and 7L2.2 and has achieved a level of 3655 competency sufficient to function independently as an authorized user of strontium-90 for 3656 ophthalmic radiotherapy uses authorized under 7.42.is able to independently fulfill the 3657 radiation safety-related duties as an authorized user of strontium-90 for ophthalmic 3658 use.
3659 and 3660 7L3 Meets the following recentness of training requirements:
3661 Commented [JJ236]: For final publication, insert a page break such that each appendix begins on a new page.
10 CFR 35.491 NRC RATS 2018-1 NRC Compatibility B Document 1 HRG Page 126 of 138
7L3.1 The training and experience required by Appendix 7L shall have been obtained within the 3662 7 years preceding the date of license application or amendment request; 3663 or 3664 7L3.2 The individual must have had related, documented, continuing education and experience 3665 since the required training and experience was obtained.
3666 or 3667 7L4 Meets the following requirements for an experienced authorized user for 7.42 opthalmic 3668 radiotherapy uses:
3669 7L4.1 An individual identified as an authorized user for the medical use of radioactive material 3670 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3671 Agreement State broad scope license that authorizes medical use before October 25, 3672 2005, who perform only those medical uses for which they were authorized on that date 3673 are not required to comply with the training requirements of 7L1 through 7L3.
3674 7L4.2 Individuals not required to comply with the training requirements of 7L1 through 7L3 may 3675 serve as preceptors for, and supervisors of, applicants seeking authorization on licenses 3676 for the same uses for which these individuals are authorized.
3677 3678 Document 1 HRG Page 127 of 138
PART 7, APPENDIX 7M: AUTHORIZED USER TRAINING FOR USE OF SEALED SOURCES IN 3679 REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC 3680 RADIOSURGERY UNITS (7.48 USES) 3681 The licensee shall require an authorized user of a sealed source for use in a device authorized under 3682 7.48 to be a physician who has a current active State of Colorado license and:Except as provided in 3683 Appendix 7P, the licensee shall require an authorized user of a sealed source for a use authorized 3684 under 7.48 to be a physician who:
3685 3686 7M1 Is certified by a medical specialty board whose certification process has been recognized by the 3687 NRC or an Agreement State and who meets the requirements in paragraph 7M2.3 and 7M3. of 3688 this Appendix. NRC recognized specialty boards are posted on the NRC website at 3689 http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html. The names of board 3690 certifications that have been recognized by the NRC or an Agreement State are posted on 3691 the NRCs Medical Uses Licensee Toolkit web page. To have its certification process 3692 recognized, a specialty board shall require all candidates for certification to:
3693 7M1.1 To have its certification process recognized, a specialty board shall require all candidates 3694 for certification to:
3695 (1)7M1.1 Successfully complete a minimum of 3 years of residency training in a radiation 3696 therapy program approved by the Residency Review Committee of the Accreditation 3697 Council for Graduate Medical Education or the Royal College of Physicians and 3698 Surgeons of Canada or the Committee on Post-GraduateCouncil on Postdoctoral 3699 Training of the American Osteopathic Association; 3700 and 3701 (1)7M1.2 Pass an examination, administered by diplomates of the specialty board, which 3702 tests knowledge and competence in radiation safety, radionuclide handling, treatment 3703 planning, quality assurance, and clinical use of stereotactic radiosurgery, remote 3704 afterloaders and external beam therapy; 3705 or 3706 7M2 Has satisfied the following criteria:
3707 7M2.1 Has satisfactorily completed a structured educational program in basic radionuclide 3708 handling techniques applicable to the use of a sealed sources in a therapeutic medical 3709 unit that includes:
3710 (1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training in the following areas:
3711 (a)
Radiation physics and instrumentation; 3712 (b)
Radiation protection; 3713 (c)
Mathematics pertaining to the use and measurement of radioactivity; and 3714 (d)
Radiation biology; 3715 and 3716 Commented [JJ237]: For final publication, insert a page break such that each appendix begins on a new page.
This appendix is updated for consistency with the 2018 changes to 10 CFR 35.690.
NRC RATS 2018-1 NRC Compatibility B Commented [JSJ238]:
Revised to use the correct terminology for the residency approval organization of the American Osteopathic Association.
Document 1 HRG Page 128 of 138
(2) 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 authorized 3717 user who meets the requirements in 7M5Appendix 7P, Appendix 7M, or 3718 equivalent Agreement State or NRC requirements at a medical institutionfacility 3719 that is authorized to use radioactive materials in 7.48, involving:
3720 (a)
Reviewing full calibration measurements and periodic spot checks; 3721 (b)
Preparing treatment plans and calculating treatment doses and times; 3722 (c)
Using administrative controls to prevent a misadministrationmedical 3723 event involving the use of radioactive material; 3724 (d)
Implementing emergency procedures to be followed in the event of the 3725 abnormal operation of the medical unit or console; 3726 (e)
Checking and using survey meters; and 3727 (f)
Selecting the proper dose and how it is to be administered; 3728 and 3729 7M2.2 Has completed 3 years of supervised clinical experience in radiation therapy, under an 3730 authorized user who meets the requirements in 7M5Appendix 7P, Appendix 7M, or 3731 equivalent Agreement State or NRC requirements, as part of a formal training program 3732 approved by the Residency Review Committee for Radiation Oncology of the 3733 Accreditation Council for Graduate Medical Education or the Royal College of Physicians 3734 and Surgeons of Canada or the CommitteeCouncil on Postdoctoral Training of the 3735 American Osteopathic Association. This experience may be obtained concurrently with 3736 the supervised work experience required by paragraph 7M2.1(2) of this section; and; 3737 and 3738 7M2.3 Has provided written attestation(s) that the individual has satisfactorily completed the 3739 requirements of 7M1 or 7M2.1 and 7M2.2, and 7M3, and has achieved a level of 3740 competency sufficient to function independently as an authorized user of each type of 3741 therapeutic medical unit for which the individual is requesting authorized user status. The 3742 written attestation must be signed by a preceptor authorized user who meets the 3743 requirements in 7M5, Appendix 7M, or equivalent Agreement State or NRC requirements 3744 for an authorized user for each type of therapeutic medical unit for which the individual is 3745 requesting authorized user status; Has obtained written attestation that the individual 3746 has satisfactorily completed the requirements in 7M2.1 and 7M2.2 and 7M3; and is 3747 able to independently fulfill the radiation safety-related duties as an authorized 3748 user of each type of therapeutic medical unit for which the individual is requesting 3749 authorized user status. The attestation must be obtained from either:
3750 (1)
A preceptor authorized user who meets the requirements in Appendix 7P, 3751 Appendix 7M, or equivalent Agreement State or NRC requirements for the 3752 type(s) of therapeutic medical unit for which the individual is requesting 3753 authorized user status; 3754 or 3755 (2)
A residency program director who affirms in writing that the attestation 3756 represents the consensus of the residency program faculty where at least 3757 one faculty member is an authorized user who meets the requirements in 3758 Appendix 7P, Appendix 7M, or equivalent Agreement State or NRC 3759 requirements, for the type(s) of therapeutic medical unit for which the 3760 Commented [JSJ239]:
Committee appear to be incorrect here and in NRC rule.
Council appears to be consistent with other uses in part 35.
Clarification from NRC is pending Commented [JSJ240]:
For recent graduates, the revised language of this provision allows for residency program directors to sign off/provide the attestations for individuals who are demonstrating training through the alternate pathway.
Document 1 HRG Page 129 of 138
individual is requesting authorized user status, and concurs with the 3761 attestation provided by the residency program director. The residency 3762 training program must be approved by the Residency Review Committee of 3763 the Accreditation Council for Graduate Medical Education or the Royal 3764 College of Physicians and Surgeons of Canada or the Council on 3765 Postdoctoral Training of the American Osteopathic Association and must 3766 include training and experience specified in 7M2.1 and 7M2.2.
3767 and 3768 7M3 Has received training in device operation, safety procedures, and clinical use for the type(s) of 3769 use for which authorization is sought. This training requirement may be satisfied by: satisfactory 3770 completion of a training program provided by the vendor for new users or by receiving 3771 training supervised by an authorized user or authorized medical physicist, as appropriate, 3772 who is authorized for the type(s) of use for which the individual is seeking authorization.
3773 7M3.1 Satisfactorily completing a vendor training program; 3774 or 3775 7M3.2 By receiving training supervised by an authorized user or authorized medical physicist, as 3776 appropriate, who is authorized for the type(s) of use for which the individual is seeking 3777 authorization; 3778 and 3779 7M4 Meets the following recentness of training requirements:
3780 7M4.1 The training and experience required by Appendix 7M shall have been obtained within 3781 the 7 years preceding the date of license application or amendment request; 3782 or 3783 7M4.2 The individual must have had related, documented, continuing education and experience 3784 since the required training and experience was obtained.
3785 or 3786 7M5 Meets the following requirements for an experienced authorized user for 7.48 uses.
3787 7M5.1 An individual identified as an authorized user for the medical use of radioactive material 3788 on a license issued by the NRC or Agreement State, a permit issued under an NRC or 3789 Agreement State broad scope license that authorizes medical use before October 25, 3790 2005, who perform only those medical uses for which they were authorized on that date 3791 are not required to comply with the training requirements of 7M1 through 7M4.
3792 7M5.2 Individuals not required to comply with the training requirements of 7M1 through 7M4 3793 may serve as preceptors for, and supervisors of, applicants seeking authorization on 3794 licenses for the same uses for which these individuals are authorized.
3795 3796 3797 Document 1 HRG Page 130 of 138
PART 7, APPENDIX 7N: NUCLEAR MEDICINE TECHNOLOGIST (NMT) ADEQUATE RADIATION 3798 SAFETY TRAINING AND EXPERIENCE 3799 The licensee shall require the nuclear medicine technologist using radioactive materials under the 3800 supervision of an authorized user to be an individual who can, upon the request of the 3801 Department, demonstrate:
3802 7N1 Has provided: Evidence of:
3803 7N1.1 Evidence of:(1) Current registration with The American Registry of Radiologic 3804 Technologists with competency in Nuclear Medicine (ARRT(N));
3805 or 3806 7N1.2(2) Current certification by The Nuclear Medicine Technology Certification Board in Nuclear 3807 Medicine (CNMT);
3808 or 3809 7N1.3(3) Being board-eligible to take the CNMT or ARRT(N) examination; 3810 or 3811 7N1.4(4) Current certification by a recognized specialty board recognized in writing by the 3812 Department(see 7N5);
3813 and 3814 7N1.2 Has provided written attestation(s), signed by a preceptor authorized user, that the 3815 individual has achieved a level of competency sufficient to function independently as a 3816 nuclear medicine technologist; 3817 (1)
Each preceptor authorized user supervising the experiential training required by 3818 Appendix 7N shall meet the requirements of Appendix 7N, or equivalent 3819 Agreement State or NRC requirements.
3820 or 3821 7N2 Has satisfied the following criteria:
3822 7N2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the 3823 individual has satisfactorily completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> in a structured educational program in 3824 basic radionuclide handling techniques applicable to the medical use of unsealed 3825 radioactive materials, including:
3826 (1)
Classroom and laboratory training in the following areas:
3827 (a)
Radiation physics and instrumentation; 3828 (b)
Radiation protection; 3829 (c)
Mathematics pertaining to the use and measurement of radioactivity; 3830 (d)
Chemistry of radioactive material for medical use; and 3831 (e)
Radiation biology; and 3832 Commented [JJ241]: There are no equivalent requirements in NRC regulations. NRC does not recognize nuclear medicine technologists.
Also see provision 7.10 of the proposed rule.
Commented [JJ242]: For final publication, insert a page break such that each appendix begins on a new page.
Commented [JSJ243]:
This proposed change eliminates the option of an alternate pathway for Nuclear Medicine Technologists, effectively requiring certification.
Document 1 HRG Page 131 of 138
(2)
Work experience, involving:
3833 (a)
Ordering, receiving, and unpacking radioactive materials safely and 3834 performing the related radiation surveys; 3835 (b)
Quality Control checking of instruments used to determine the activity of 3836 dosages and performing checks for proper operation of survey meters; 3837 (c)
Calculating, measuring, and safely preparing patient or human research 3838 subject dosages; 3839 (d)
Using administrative controls to prevent a misadministration involving the 3840 use of unsealed radioactive material; 3841 (e)
Using procedures to contain spilled radioactive material safely and using 3842 proper decontamination procedures; and 3843 (f)
Administering dosages to patients or human research subjects; 3844 7N2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the 3845 individual has achieved a level of competency sufficient to function independently as a 3846 nuclear medicine technologist; 3847 or 3848 7N32 Has demonstratedIs able to demonstrate adequate prior experience as:
3849 7N32.1 A full-time nuclear medicine technologist for a minimum of two years performing during 3850 the past five-year period prior to August 14, 2020 under the supervision of an 3851 authorized user and has provided written attestation(s), signed by a preceptor authorized 3852 user, that the individual has achieved a level of competency sufficient to function 3853 independently as a nuclear medicine technologist; 3854 or 3855 7N32.2 An experienced nuclear medicine technologist working at a facility holding a Department 3856 license before October 25, 2005. (and thus need not comply with the requirements of 3857 7N2);
3858 7N4 Meets the following recentness of training requirements:
3859 7N4.1 The training and experience required by Appendix 7N shall have been obtained within the 3860 7 years preceding the date of license application or amendment request; 3861 or 3862 7N4.2 The individual must have had related, documented, continuing education and experience 3863 since the required training and experience was obtained.
3864 7N5 To be recognized by the Department, a specialty board shall require that each candidate for 3865 certification as a nuclear medicine technologist satisfactorily complete a certification process that 3866 includes all of the training requirements in 7N2.1.
3867 3868 Document 1 HRG Page 132 of 138
PART 7, APPENDIX 7O: RADIATION THERAPY TECHNOLOGIST (RTT) ADEQUATE RADIATION 3869 SAFETY TRAINING AND EXPERIENCERESERVED 3870 The licensee shall require the radiation therapy technologist using radioactive materials under the 3871 supervision of an authorized user to be an individual who:
3872 7O1 Has provided:
3873 7O1.1 Evidence of:
3874 (1)
Current registration with The American Registry of Radiologic Technologists with 3875 competency in Radiation Therapy; 3876 or 3877 (2)
Current certification by a recognized specialty board (see 7O5);
3878 or 3879 (3)
Being board-eligible to take the ARRT(T) examination; 3880 or 3881 (4)
Having successfully completed a training program in radiation therapy which has 3882 resulted in a certificate, associate degree, or baccalaureate degree in a 3883 radiologic technology program that complies with the requirements of the Joint 3884 Review Committee on Education in Radiologic Technology (consult the 3885 Essentials and Guidelines of an Accredited Educational Program for the 3886 Radiation Therapy Technologist, Joint Review Committee on Education in 3887 Radiologic Technology, 1988);
3888 and 3889 7O1.2 Written attestation(s), signed by a preceptor authorized user, that the individual has 3890 achieved a level of competency sufficient to function independently as a radiation therapy 3891 technologist; 3892 (1)
Each preceptor authorized user supervising the experiential training required by 3893 Appendix 7O shall meet the requirements of Appendix 7O, or equivalent 3894 Agreement State or NRC requirements.
3895 or 3896 7O2 Has satisfied the following criteria:
3897 7O2.1 Has provided written attestation(s), signed by a preceptor authorized user, that the 3898 individual has satisfactorily completed 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> in a structured educational program in 3899 basic radionuclide handling techniques applicable to the medical use of unsealed 3900 radioactive materials, including:
3901 (1)
Classroom and laboratory training in the following areas:
3902 (a)
Radiation physics and instrumentation; 3903 (b)
Radiation protection; 3904 Commented [JSJ244]:
The requirements of this appendix is proposed for deletion as it is generally not used by the radiation program during licensing or compliance activities. The radiation program is generally unaware of radiation therapy technologists who are performing activities involving radioactive material.
Requirements for radiation therapy technologists are generally dictated by the specific facilities occupational and/or accreditation requirements.
There is no equivalent to these requirements in 10 CFR Part
- 35.
Document 1 HRG Page 133 of 138
(c)
Mathematics pertaining to the use and measurement of radioactivity; 3905 (d)
Radiation biology; 3906 and 3907 (2)
Work experience, involving:
3908 (a)
Ordering, receiving, and unpacking radioactive materials safely and 3909 performing the related radiation surveys; 3910 (b)
Assisting the authorized user in simulating the patient for treatment; 3911 (c)
Preparing the patient for treatment; 3912 (d)
Implementing treatment plans as prescribed by the authorized user; 3913 (e)
Providing written documentation of treatment setup and patient 3914 treatments; 3915 (f)
Quality control checks to determine that devices used to deliver the 3916 radiation doses are in compliance with institutional standards and 3917 performing checks for proper operation of survey meters; 3918 (g)
Preparing or assisting in the preparation of sources, and implantation 3919 and removal of sealed sources; 3920 (h)
Delivering doses to patients or human research subjects under the 3921 supervision of the authorized user; 3922 (i)
Maintaining running inventories of radioactive material on hand; 3923 (j)
Using administrative controls to prevent a misadministration involving the 3924 use of radioactive material; and, 3925 (k)
Properly implementing emergency procedures; 3926 7O2.2 Has provided written attestation(s), signed by a preceptor authorized user, that the 3927 individual has achieved a level of competency sufficient to function independently as a 3928 radiation therapy technologist; 3929 or 3930 7O3 Has demonstrated adequate prior experience as:
3931 7O3.1 A full-time radiation therapy technologist for a minimum of two years performing during 3932 the past five-year period under the supervision of an authorized user and has provided 3933 written attestation(s), signed by a preceptor authorized user, that the individual has 3934 achieved a level of competency sufficient to function independently as a radiation therapy 3935 technologist; 3936 or 3937 7O3.2 An experienced radiation therapy technologist working at a facility holding a Department 3938 license before October 25, 2005 (and thus need not comply with the requirements of 3939 7O2);
3940 Document 1 HRG Page 134 of 138
7O4 Meets the following recentness of training requirements:
3941 7O4.1 The training and experience required by Appendix 7O shall have been obtained within 3942 the 7 years preceding the date of license application or amendment request; 3943 or 3944 7O4.2 The individual must have had related, documented, continuing education and experience 3945 since the required training and experience was obtained.
3946 7O5 To be recognized by the Department, a specialty board shall require that each candidate for 3947 certification as a radiation therapy technologist satisfactorily complete a certification process that 3948 includes all of the training requirements in 7O2.1.
3949 3950 Document 1 HRG Page 135 of 138
PART 7, APPENDIX 7P: TRAINING FOR EXPERIENCED RADIATION SAFETY OFFICER, 3951 TELETHERAPY OR MEDICAL PHYSICIST, AUTHORIZED MEDICAL PHYSICIST, AUTHORIZED 3952 USER, NUCLEAR PHARMACIST, AND AUTHORIZED NUCLEAR PHARMACIST.
3953 7P1 3954 7P1.1 An individual identified on a Department, NRC or an Agreement State license or a 3955 permit issued by a Department, NRC or an Agreement State broad scope licensee 3956 or master material license permit or by a master material license permittee of 3957 broad scope as a Radiation Safety Officer, a teletherapy or medical physicist, an 3958 authorized medical physicist, a nuclear pharmacist or an authorized nuclear 3959 pharmacist on or before August 14, 2020 need not comply with the training 3960 requirements of Appendix 7A, 7B, or 7C, respectively, except the Radiation Safety 3961 Officers and authorized medical physicists identified in 7P1.1 must meet the 3962 training requirements in 7A4 of Appendix 7A or 7B3 of Appendix 7B, as 3963 appropriate, for any material or uses for which they were not authorized prior to 3964 this date.
3965 7P1.2 Any individual certified by the American Board of Health Physics in 3966 Comprehensive Health Physics; American Board of Radiology; American Board of 3967 Nuclear Medicine; American Board of Science in Nuclear Medicine; Board of 3968 Pharmaceutical Specialties in Nuclear Pharmacy; American Board of Medical 3969 Physics in radiation oncology physics; Royal College of Physicians and Surgeons 3970 of Canada in nuclear medicine; American Osteopathic Board of Radiology; or 3971 American Osteopathic Board of Nuclear Medicine on or before October 24, 2005, 3972 need not comply with the training requirements of Appendix 7A to be identified as 3973 a Radiation Safety Officer or as an Associate Radiation Safety Officer on an NRC or 3974 an Agreement State license or NRC master material license permit for those 3975 materials and uses that these individuals performed on or before October 24, 2005.
3976 7P1.3 Any individual certified by the American Board of Radiology in therapeutic 3977 radiological physics, Roentgen ray and gamma ray physics, xray and radium 3978 physics, or radiological physics, or certified by the American Board of Medical 3979 Physics in radiation oncology physics, on or before October 24, 2005, need not 3980 comply with the training requirements for an authorized medical physicist 3981 described in Appendix 7B, for those materials and uses that these individuals 3982 performed on or before October 24, 2005.
3983 7P1.4 A Radiation Safety Officer, a medical physicist, or a nuclear pharmacist, who used 3984 only accelerator-produced radioactive materials, discrete sources of radium-226, 3985 or both, for medical uses or in the practice of nuclear pharmacy at a Government 3986 agency or Federally recognized Indian Tribe before November 30, 2007, or at all 3987 other locations of use before August 8, 2009, or an earlier date as noticed by the 3988 NRC, need not comply with the training requirements of Appendix 7A, 7B, or 7C 3989 respectively, when performing the same uses. A nuclear pharmacist, who prepared 3990 only radioactive drugs containing accelerator-produced radioactive materials, or a 3991 medical physicist, who used only accelerator-produced radioactive materials, at 3992 the locations and during the time period identified in 7P1.4, qualifies as an 3993 authorized nuclear pharmacist or an authorized medical physicist, respectively, for 3994 those materials and uses performed before these dates, for the purposes of the 3995 regulations.
3996 7P2 3997 7P2.1 Physicians, dentists, or podiatrists identified as authorized users for the medical 3998 use of radioactive material on a license issued by the NRC or an Agreement State, 3999 a permit issued by a NRC master material licensee, a permit issued by a NRC or an 4000 Commented [JJ245]:
This is a new appendix that parallels the requirements found in 10 CFR 35.57, which was amended in 2018.
Some requirements of this appendix are already contained in and are repeated multiple times in the existing Appendices of Part 7. Within this proposed rule, the requirements for an experienced authorized individual (such as RSO, medical physicist, authorized user, etc.) would be captured in one location rather than being repeated in multiple locations in the rule, parallel with the approach used in 10 CFR 35. This appendix will consolidate the requirements in one location and replace multiple (repeated) provisions found in other appendices.
As a result of the 2018 changes to the CFR, the following provisions are new: 7P1.2, 7P1.3, and 7P2.2(1) through (4).
These provisions were added to federal rule in 2018 based on a stakeholder petition to NRC to address (correct) a grandfathering related issue that existed in the (federal) rule prior to 2018.
August 14, 2020 is the anticipated effective date of the Part 7 rule under the current rulemaking schedule.
NRC RATS 2018-1 All provisions are NRC Compatibility B, with the exception of 7P1.4, which is compatibility D.
Document 1 HRG Page 136 of 138
Agreement State broad scope licensee, or a permit issued by a NRC master 4001 material license broad scope permittee on or before August 14, 2020, who perform 4002 only those medical uses for which they were authorized on or before that date 4003 need not comply with the training requirements of Sections D through H.
4004 7P2.2 Physicians, dentists, or podiatrists not identified as authorized users for the 4005 medical use of radioactive material on a license issued by the NRC or an 4006 Agreement State, a permit issued by a NRC master material licensee, a permit 4007 issued by a NRC or an Agreement State broad scope licensee, or a permit issued 4008 by a NRC master material license of broad scope on or before October 24, 2005, 4009 need not comply with the training requirements of Sections D through H for those 4010 materials and uses that these individuals performed on or before October 24, 2005, 4011 as follows:
4012 (1)
For uses authorized under 7.30 or 7.32, or oral administration of sodium 4013 iodide I-131 requiring a written directive for imaging and localization 4014 purposes, a physician who was certified on or before October 24, 2005, in 4015 nuclear medicine by the American Board of Nuclear Medicine; diagnostic 4016 radiology by the American Board of Radiology; diagnostic radiology or 4017 radiology by the American Osteopathic Board of Radiology; nuclear 4018 medicine by the Royal College of Physicians and Surgeons of Canada; or 4019 American Osteopathic Board of Nuclear Medicine in nuclear medicine; 4020 (2)
For uses authorized under 7.36, a physician who was certified on or before 4021 October 24, 2005, by the American Board of Nuclear Medicine; the 4022 American Board of Radiology in radiology, therapeutic radiology, or 4023 radiation oncology; nuclear medicine by the Royal College of Physicians 4024 and Surgeons of Canada; or the American Osteopathic Board of Radiology 4025 after 1984; 4026 (3)
For uses authorized under 7.42 or 7.48, a physician who was certified on or 4027 before October 24, 2005, in radiology, therapeutic radiology or radiation 4028 oncology by the American Board of Radiology; radiation oncology by the 4029 American Osteopathic Board of Radiology; radiology, with specialization in 4030 radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of 4031 the Royal College of Radiology"; or therapeutic radiology by the Canadian 4032 Royal College of Physicians and Surgeons; and 4033 (4)
For uses authorized under 7.40, a physician who was certified on or before 4034 October 24, 2005, in radiology, diagnostic radiology, therapeutic radiology, 4035 or radiation oncology by the American Board of Radiology; nuclear 4036 medicine by the American Board of Nuclear Medicine; diagnostic radiology 4037 or radiology by the American Osteopathic Board of Radiology; or nuclear 4038 medicine by the Royal College of Physicians and Surgeons of Canada.
4039 7P2.3 Physicians, dentists, or podiatrists who used only accelerator-produced 4040 radioactive materials, discrete sources of radium-226, or both, for medical uses 4041 performed at a Government agency or Federally recognized Indian Tribe before 4042 November 30, 2007, or at all other locations of use before August 8, 2009, or an 4043 earlier date as noticed by the NRC, need not comply with the training requirements 4044 of Sections D through H when performing the same medical uses. A physician, 4045 dentist, or podiatrist, who used only accelerator-produced radioactive materials, 4046 discrete sources of radium-226, or both, for medical uses at the locations and time 4047 period identified in 7P2, qualifies as an authorized user for those materials and 4048 uses performed before these dates, for the purposes of the regulations.
4049 Document 1 HRG Page 137 of 138
7P3 Individuals who need not comply with training requirements as described in Appendix 7P 4050 may serve as preceptors for, and supervisors of, applicants seeking authorization on 4051 Department licenses for the same uses for which these individuals are authorized.
4052 4053 Document 1 HRG Page 138 of 138