Rhb Form 313A Ce PDF Details

In the evolving landscape of radiology and nuclear medicine, the importance of maintaining rigorous standards for authorized users cannot be overstated. Among the raft of documentation and regulatory compliance requirements, the RHB Form 313A (CE) emerges as a critical tool in the California Department of Public Health's armory. Issued in July 2010, this document serves a dual purpose: it is both a testament to the completion of required refresher training and an attestation by a preceptor on a candidate's readiness to handle radioactive materials for a range of medical applications, including but not limited to uptake, dilution, excretion studies, imaging, and localization studies, as well as the use of unsealed byproduct material across a variety of clinical uses under specific sections of the 10 CFR 35. The form meticulously outlines the prerequisites for individuals seeking authorization or continuation of their status as authorized users. It encapsulates the essence of comprehensive training and hands-on experience in the field, requiring detailed documentation of continuing education, prior authorization, board certification, and clinical training experience accumulated over recent years. Moreover, it emphasizes the relationship between the aspiring authorized user and their preceptor, who plays a pivotal role in validating the candidate's competence and readiness to perform independently in a highly specialized and sensitive medical field.

QuestionAnswer
Form NameRhb Form 313A Ce
Form Length4 pages
Fillable?No
Fillable fields0
Avg. time to fill out1 min
Other namesRHB RML 313A(CE) rhb313a form

Form Preview Example

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

RHB FORM 313A (CE)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

AUTHORIZED USER REFRESHER TRAINING AND PRECEPTOR ATTESTATION (for uses defined under 35.100, 35.200, 35.300, 35.400, 35.500, and 35.600) [10CFR 35.190, 35.290, 35.390, 35.392, 35.394, 35.396, 35.590, and 35.690]

Name of Proposed Authorized User

State or Territory Where Licensed

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 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

35.400 Manual Brachytherapy sources 35.400 Opthalmic use of Strontium-90

35.500

Sealed sources for diagnosis (specify device_____________________)

35.600

Remote afterloader unit(s)

35.600 Teletherapy unit(s)

35.600 Gamma stereotactic radiosurgery unit(s)

PART I – TRAINING AND EXPERIENCE

(Complete entire section)

*Training and Experience, including board certification, must have been obtained within the seven years preceding the date of application or the individual must have obtained related continuing education and experience since the initial required training and experience was completed. Provide dates, duration, and description of continuing education and experience related to the types of uses checked above, obtained within the past seven years.

1. Training and experience obtained over seven years ago:

1. Board Certification

OSpecialty Board and Category: ___________________________________________

OMonth and Year Certified: _______________________________________________

OR

2. Past Authorized User

OCalifornia Radioactive Materials Number: _______________________, or attach a copy of the NRC or Agreement State License.

Page 1 of 4

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

RHB FORM 313A (CE)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

CONTINUING EDUCATION AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

2. Continuing education and experience within the past seven years:

 

 

 

 

Type and Length of Training

 

 

 

 

LECTURE/

 

SUPERVISED

 

 

 

 

LABORATORY

LABORATORY

 

 

 

 

COURSES

 

EXPERIENCE

FIELD OF TRAINING

LOCATION AND DATES OF TRAINING

(HOURS)

 

(HOURS)

A

 

B

C

 

D

a. Radiation physics and instrumentation

 

 

 

 

 

 

 

b. Radiation protection

 

 

 

 

 

 

 

c. Mathematics pertaining to use and

 

 

 

 

 

 

 

measurement of radioactivity

 

 

 

 

 

 

 

d. Chemistry of byproduct material for

 

 

 

 

 

 

 

medical use (not required for 35.590)

 

 

 

 

 

 

 

e. Radiation biology

 

 

 

 

 

 

 

4. Clinical Training and Experience (Use back if more space is needed)

 

 

 

 

For 35.300 or any subset of clinical uses under 35.300, complete this section. For all others, skip to page 3.

 

 

 

Number of Cases

 

Location of Experience/License

 

 

 

Description of Experience

Involving Personal

 

 

Dates of Experience*

 

or Permit Number of Facility

 

 

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

 

 

With experience administering dosages of:

 

 

 

Oral NaI-131 requiring a written directive in quantities less

35.392

 

 

than or equal to 1.22 gigabecquerels (33 millicuries)

 

 

 

 

 

 

 

35.394

 

 

Oral NaI-131 in quantities greater than 1.22

 

 

gigabecquerels (33 millicuries)

 

 

35.396

 

 

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 2 of 4

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

RHB FORM 313A (CE)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

CONTINUING EDUCATION AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

KEY TO COLUMN C—Personal participation consists of:

a.Supervised examination of patients to determine the suitability for radionuclide diagnosis and/or treatment and recommendation for prescribed dosage.

b.Dose calibration and actual administration of dose to the patient including calculation of the radiation dose and related measurements.

c.Supervised interpretation of results of diagnostic studies.

d.Adequate period of training to enable physician to manage radioactive patients and follow patients through diagnosis and therapy.

ISOTOPE

A

CONDITIONS DIAGNOSED OR

TREATED

B

NUMBER OF

CASES

INVOLVING

PERSONAL

PARTICIPATION

C

COMMENTS

(Additional information or comments may be submitted in duplicate on separate sheets)

D

Complete Part II Preceptor Attestation.

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

I attest that __________________________________ has satisfactorily completed the training and experience

Name of Proposed Authorized User

documented in this form and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses requested above.

Page 3 of 4

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

RHB FORM 313A (CE)

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

(7-2010)

CONTINUING EDUCATION AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)

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 4 of 4