Rhb Form 313A PDF Details

Navigating through the complexities of the RHB 313A form reveals a meticulous framework designed to validate and acknowledge the expertise of individuals aiming to become authorized users of radioactive materials within medical settings in California. This form, serving as a gateway, ensures that applicants possess the necessary training, experience, and board certification relevant to the specialty they wish to practice. It meticulously categorizes authorization requirements into areas such as the use of unsealed byproduct material, uptake, dilution, excretion studies, and imaging, alongside localization studies which demand strict adherence to protocols for safety and effectiveness. Additionally, the form extends to those seeking to broaden their scope of practice, necessitating documentation of further education and hands-on experience. At its core, the RHB 313A form embodies a comprehensive attestation process, inclusive of a preceptor's verification of an applicant's capabilities, solidifying the individual's competence and ensuring public health and safety. This structured approach not only underscores the significance of specialized training but also emphasizes ongoing education, making it a pivotal component in the licensing and regulation of medical professionals handling radioactive substances.

QuestionAnswer
Form NameRhb Form 313A
Form Length7 pages
Fillable?No
Fillable fields0
Avg. time to fill out1 min 45 sec
Other namesParenteral, NaI-131, RHB, 10cfr35

Form Preview Example

□
PART I – TRAINING AND EXPERIENCE (Select one of the three methods below)
* Training and Experience, including board certification, must have been obtained within the 7 years preceding the date of application or the individual must have obtained related continuing education and experience since the required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the uses checked above.
□1. Board Certification
a. Provide a copy of the board certification in appropriate specialty.
b. If using only 35.500 materials, stop here. If using only 35.100 and 35.200 materials, skip to and complete Part II Preceptor Attestation.
c. For 35.390, provide documentation on supervised clinical case experience. The table in section 3.c. may be used to document this experience. Complete Part II Preceptor Attestation.
d. For 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Complete Part II Preceptor Attestation.
□2. Current Authorized User Seeking Additional Authorization
a. Authorized User on California Radioactive Materials License Number: ________________, under the requirements below
35.500 Sealed sources for diagnosis (specify device_____________________)
OR (select one of the subset of clinical uses for 35.300)
□35.300 Oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)
□35.300 Oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries)
□35.300 Parenteral administration of any beta-emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
□35.300 Parenteral administration of any other radionuclide for which a written directive is required
Requested Authorizations (check all that apply)
□ 35.100 Uptake, dilution, and excretion studies □ 35.200 Imaging and localization studies
□ 35.300 Use of unsealed byproduct material for which a written directive is required
Name of Proposed Authorized User
State or Territory Where Licensed
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION
(for uses defined under 35.100, 35.200, 35.300, and 35.500)
[10CFR 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, and 35.590]
RHB FORM 313A (AU) (7-2010)
CALIFORNIA DEPARTMENT OF PUBLIC HEALTH
For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

or equivalent Agreement State requirements (attach a copy of the NRC or Agreement State license). Check all that apply.

□35.190 □ 35.290

□

35.390

or

□ 35.392 and/or □

35.394

□

35.490

or

□ 35.491 only □

35.690

Page 1 of 7

For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

RHB FORM 313A (AU)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

b.If currently authorized under 35.100 requesting 35.200 authorization, provide documentation on classroom and laboratory training and supervised work experience. The tables in sections 3.a. and 3.b. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

c.If currently authorized under 35.100 and/or 35.200 and requesting 35.300 authorization, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

d.If currently authorized for 35.390 and requesting authorization for 35.290 only, provide documentation on generator experience in table 3.b.

e.If currently authorized for a subset of clinical uses under 35.300, requesting additional subset of clinical uses, provide documentation on additional required supervised clinical case experience. The table in section 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation. If requesting 35.100, 35.200, and/or 35.300 authorization(s), provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

f.If currently authorized under 35.490 or 35.690 and requesting authorization for 35.396, provide documentation on classroom and laboratory training, supervised work experience, and supervised clinical case experience. The tables in sections 3.a., 3.b., and 3.c. may be used to document this experience. Also provide completed Part II Preceptor Attestation.

g.If currently authorized under any of the above uses and seeking 35.500 authorization, provide documentation on training on use of the requested device(s). Table in section 3.d. may be used to document this experience.

□3. Training and Experience for Proposed Authorized User

a.Classroom and Laboratory Training (completion of this table is required for all authorizations)

Description of Training

Location of Training

Clock Hours

Dates of

Training*

 

 

 

 

 

 

 

Radiation physics and instrumentation

 

 

 

 

 

 

 

Radiation protection

 

 

 

 

 

 

 

Mathematics pertaining to the use and

 

 

 

measurement of radioactivity

 

 

 

 

 

 

 

Chemistry of byproduct material for medical

 

 

 

use (not required for 35.590)

 

 

 

 

 

 

 

Radiation biology

 

 

 

 

 

 

 

 

Total Hours of Training:

 

 

 

 

 

 

b.Supervised Work Experience (completion of this table is not required for 35.590).

(If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.)

Supervised Work Experience

 

Total Hours of Experience:

 

 

 

 

 

 

Description of Experience

Location of Experience/License or Permit

Confirm

Dates of

Must Include:

Number of Facility

Experience*

 

 

 

 

 

 

Ordering, receiving, and unpacking

 

 

□ Yes

 

radioactive materials safely and

 

 

 

performing the related radiation surveys

 

 

□ No

 

 

 

 

 

Page 2 of 7

For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

RHB FORM 313A (AU)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

 

 

 

 

 

 

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Performing quality control procedures on

 

□

Yes

 

 

 

instruments used to determine the

 

 

 

 

 

 

 

 

activity of dosages and performing

 

 

 

 

 

checks for proper operation of survey

 

□ No

 

 

 

meters

 

 

 

Calculating, measuring, and safely

 

□ Yes

 

 

 

preparing patient or human research

 

 

 

subject dosages

 

□ No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Using administrative controls to prevent

 

□ Yes

 

 

 

a medical event involving the use of

 

 

 

unsealed byproduct material

 

□ No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Using procedures to contain spilled

 

□ Yes

 

 

 

byproduct material safely and using

 

 

 

proper decontamination procedures

 

□ No

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Administering dosages of radioactive

 

□ Yes

 

 

 

drugs to patients or human research

 

 

 

subjects (not required for 35.390, 35.392,

 

□ No

 

 

 

35.394, and 35.396)

 

 

 

Eluting generator systems appropriate

 

□ Yes

 

 

 

for the preparation of radioactive drugs

 

 

 

for imaging and localization studies,

 

□

 

 

 

 

measuring and testing the eluate for

 

No

 

 

radionuclide purity, and processing the

 

 

 

 

 

eluate with reagent kits to prepare

 

 

 

 

 

 

labeled radioactive drugs (required for

 

 

 

 

 

35.290)

 

 

 

 

 

 

 

 

 

 

 

 

Supervising Individual

License/Permit Number listing supervising individual as an authorized user (if not listed on a California Radioactive Materials License, attach a copy of NRC or Agreement State license)

Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply)**.

□35.190

□35.290

□35.390

□35.390 + generator

experience in 35.290(c)(1)(ii)(G)

□ 35.392

□ 35.394

□ 35.396

With experience administering dosages of:

□Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

□Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

□Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive

□Parenteral administration of any other radionuclide requiring a written directive

**Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

Page 3 of 7

For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

RHB FORM 313A (AU)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

c.Supervised Clinical Case Experience (completion of this table is not required for 35.190, 35.290, and 35.590)

(If more than one supervising individual is necessary to document supervised work experience, provide multiple copies of this section.)

 

Number of Cases

Location of Experience/License

Dates of

Description of Experience

Involving Personal

or Permit Number of Facility

Experience*

 

Participation

 

 

 

Oral administration of sodium iodide I-131

 

 

 

requiring a written directive in quantities less

 

 

 

than or equal to 1.22 gigabecquerels (33

 

 

 

millicuries)

 

 

 

 

 

 

 

Oral administration of sodium iodide I-131

 

 

 

requiring a written directive in quantities

 

 

 

greater than 1.22 gigabecquerels (33

 

 

 

millicuries)

 

 

 

 

 

 

 

Parenteral administration of any beta-emitter,

 

 

 

or photon-emitting radionuclide with a photon

 

 

 

energy less than 150 keV for which a written

 

 

 

directive is required

 

 

 

Parenteral administration of any other

 

 

 

radionuclide for which a written directive is

 

 

 

required

 

 

 

(List radionuclides)

 

 

 

 

 

 

 

Supervising Individual

License/Permit Number listing supervising individual as an authorized user (if not listed on a California Radioactive Materials License, attach a copy of NRC or Agreement State license)

Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply)**.

□35.390

□35.392

□35.394

□35.396

With experience administering dosages of:

□Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

□Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

□Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive

□Parenteral administration of any other radionuclide requiring a written directive

**Supervising Authorized User must have experience in administering dosages in the same dosage category or categories as the individual requesting authorized user status.

d.For 35.590 only, provide documentation of training on use of the device.

Device

Type of Training

Location and Dates

e. For 35.500 uses only, stop here. For All other uses, complete Part II Preceptor Attestation.

Page 4 of 7

For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

RHB FORM 313A (AU)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

PART II – PRECEPTOR ATTESTATION

Note: This part must be completed by the individual's preceptor. The preceptor does not have to be the supervising individual as long as the preceptor provides, directs, or verifies training and experience required. If more than one preceptor is necessary to document experience, obtain a separate preceptor statement from each.

By checking the boxes below, the preceptor is attesting that the individual has knowledge to fulfill the duties of the position sought and not attesting to the individual's "general clinical competency."

First Section

For 35.190: Check one of the following and skip to Third Section

Board Certification

□I attest that __________________________________ has satisfactorily completed the training and experience

Name of Proposed Authorized User

requirements 10 CFR 35.190(a)(1) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100.

OR

Training and Experience

□I attest that __________________________________ has satisfactorily completed the 60 hours of training and

Name of Proposed Authorized User

experience, including a minimum of 8 hours of classroom and laboratory training, as required by 10 CFR 35.190(c)(1), and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100.

For 35.290: Check one of the following and skip to Third Section

Board Certification

□I attest that __________________________________ has satisfactorily completed the training and experience

Name of Proposed Authorized User

requirements 10 CFR 35.290(a)(1) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 10 CFR 35.200.

OR

Training and Experience

□I attest that __________________________________ has satisfactorily completed the 700 hours of training and

Name of Proposed Authorized User

experience, including a minimum of 80 hours of classroom and laboratory training, as required by 10 CFR 35.290(c)(1), and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 10 CFR 35.100 and 10 CFR 35.200.

For 35.390: Check one of the following and continue to Second Section

Board Certification

□I attest that __________________________________ has satisfactorily completed the training and experience

Name of Proposed Authorized User

requirements in 35.390(a)(1).

OR

Page 5 of 7

OR
Current 35.490 or 35.690 Authorized User:
□ I attest that __________________________________ is an authorized user under 10 CFR 35.490 or 35.690 or
Name of Proposed Authorized User
equivalent Agreement State requirements, has satisfactorily completed the 80 hours of classroom and laboratory training, as required by 10 CFR 35.396 (d)(1), and the supervised work and clinical case experience required by 35.396(d)(2), and has achieved a level of competency sufficient to function independently as an authorized user for:
Page 6 of 7
Parenteral administration of any other radionuclide for which a written directive is required
□
Name of Proposed Authorized User
requirements of 35.396(c), has satisfactorily completed the 80 hours of classroom and laboratory training required by 10 CFR 35.396 (d)(1) and the supervised work and clinical case experience required by 35.396(d)(2), and has achieved a level of competency sufficient to function independently as an authorized user for:
□ Parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required
Name of Proposed Authorized User
laboratory training, as required by 10 CFR 35.394 (c)(1), and the supervised work and clinical case experience required in 35.394(c)(2).
For 35.396: Check one of the following and continue to Second Section Board Certification:
□ I attest that __________________________________ has satisfactorily completed the board certification
I attest that __________________________________ has satisfactorily completed the 80 hours of training and
□
Name of Proposed Authorized User
laboratory training, as required by 10 CFR 35.392 (c)(1), and the supervised work and clinical case experience required in 35.392(c)(2).
For 35.394 (Identical Attestation Statement Regardless of Training and Experience Pathway): Check one of the following and continue to Second Section
I attest that __________________________________ has satisfactorily completed the 80 hours of training and
□
Name of Proposed Authorized User
requirements in 35.290(a)(1) and additional training as required by 10 CFR 35.390(b)(1).
For 35.392 (Identical Attestation Statement Regardless of Training and Experience Pathway): Check one of the following and continue to Second Section
I attest that __________________________________ has satisfactorily completed the training and experience
□
I attest that __________________________________ has satisfactorily completed the 700 hours of training and
Name of Proposed Authorized User
experience, including a minimum of 200 hours of classroom and laboratory training, as required by 10 CFR 35.390(b)(1).
OR
□

For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

RHB FORM 313A (AU)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

Training and Experience

For 2008 10 CFR 35, visit http://www.access.gpo.gov/nara/cfr/waisidx_08/10cfr35_08.html.

RHB FORM 313A (AU)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

□Parenteral administration of any beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required

□Parenteral administration of any other radionuclide for which a written directive is required

Second Section (required for 35.390, 35.392, 35.394, and 35.396 only)

Complete and continue to Third Section

□I attest that __________________________________ has satisfactorily completed the required clinical case

Name of Proposed Authorized User

experience required in 35.390(b)(1)(ii)(G) listed below, and has satisfactorily achieved a level of competency to function independently as an authorized user for:

□Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

□Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

□Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive

□Parenteral administration of any other radionuclide requiring a written directive

Third Section

Complete the following for preceptor attestation and signature:

□I meet the requirements below, or equivalent Agreement State requirements, as an authorized user for:

□ 35.190

□ 35.290

□ 35.390

□ 35.390+ generator experience

□ 35.392

□ 35.394

□ 35.396

 

Complete the following for 35.390, 35.392, 35.394, and 35.396.

□I have experience administering dosages in the following categories for which the proposed Authorized User is requesting authorization.

□Oral NaI-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries)

□Oral NaI-131 in quantities greater than 1.22 gigabecquerels (33 millicuries)

□Parenteral administration of beta-emitter, or photon-emitting radionuclide with a photon energy less than 150 keV requiring a written directive

□Parenteral administration of any other radionuclide requiring a written directive

Name of Preceptor

Signature

Telephone Number

Date

License/Permit Number and Facility Name (if not a California Radioactive Materials License, attach a copy of NRC or Agreement State license)

Page 7 of 7

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