Fillable Nrc Form 313a Aud (Saint Louis University)

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Nrc Form 313a Aud (Saint Louis University)

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Supervisor meets the requirements below, or equivalent Agreement State requirements (check all that apply).
35.500 Sealed sources for diagnosis (specify device)
NRC FORM 313A (AUD)
(06-2016)
AUTHORIZED USER TRAINING AND EXPERIENCE
AND PRECEPTOR ATTESTATION
(for uses defined under 35.100, 35.200, and 35.500)
[10 CFR 35.190, 35.290, and 35.590]
U.S. NUCLEAR REGULATORY COMMISSION
NRC FORM 313A (AUD) (06-2016)
PAGE 1
APPROVED BY OMB: NO. 3150-0120
EXPIRES: 06/30/2019
Name of Proposed Authorized User
State or Territory Where Licensed
Requested Authorization(s) (check all that apply)
35.100 Uptake, dilution, and excretion studies
35.200 Imaging and localization studies
PART I -- TRAINING AND EXPERIENCE
(Select one of the three methods below)
1. Board Certification
a. Provide a copy of the board certification.
b. If using only 35.500 materials, stop here. If using 35.100 and 35.200 materials, skip to and complete Part II
Preceptor Attestation.
2. Current 35.390 Authorized User Seeking Additional 35.290 Authorization
a. Authorized user on Materials License
meeting 10 CFR 35.390 or equivalent Agreement
State requirements seeking authorization for 35.290.
Description of Experience
Eluting generator systems
appropriate for the preparation of
radioactive drugs for imaging and
localization studies, measuring and
testing the eluate for radionuclidic
purity, and processing the eluate
with reagent kits to prepare labeled
radioactive drugs
Location of Experience/License or
Permit Number of Facility
Clock
Hours
Dates of
Experience*
Total Hours of Experience:
35.290 35.390 + generator experience in 32.290(c)(1)(ii)(G)
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.
*
b. Supervised Work Experience.
(If more than one supervising individual is necessary to document supervised work experience, provide multiple
copies of this section.)
Supervising Individual
License/Permit Number listing supervising individual as an
authorized user
NRC FORM 313A (AUD)
(06-2016)
U.S. NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
3. Training and Experience for Proposed Authorized User
Description of Training
Radiation physics and
instrumentation
Location of Training
Clock
Hours
Dates of
Training*
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:
Description of Experience
Must Include:
Ordering, receiving, and unpacking
radioactive materials safely and
performing the related radiation
surveys
Location of Experience/License or
Permit Number of Facility
Confirm
Dates of
Experience*
Performing quality control
procedures on instruments used to
determine the activity of dosages
and performing checks for proper
operation of survey meters
PAGE 2
Classroom and Laboratory Training.a.
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.)
b.
Total Hours of
Experience:
Supervised Work Experience
No
Yes
No
Yes
NRC FORM 313A (AUD) (06-2016)
NRC FORM 313A (AUD)
(06-2016)
U.S. NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
Supervising Individual
License/Permit Number listing supervising individual as an
authorized user
Supervisor meets the requirements below, or equivalent Agreement State requirements (check one).
35.190 35.290 35.390 35.390 + generator experience in 35.290(c)(1)(ii)(G)
Device Type of Training Location and Dates
PAGE 3
Description of Experience
Must Include:
Location of Experience/License or
Permit Number of Facility
Confirm
Dates of
Experience*
Using administrative controls to
prevent a medical event involving the
use of unsealed byproduct material
Using procedures to contain spilled
byproduct material safely and using
proper decontamination procedures
Administering dosages of radioactive
drugs to patients or human research
subjects
Eluting generator systems appropriate
for the preparation of radioactive
drugs for imaging and localization
studies, measuring and testing the
eluate for radionuclidic purity, and
processing the eluate with reagent
kits to prepare labeled radioactive
drugs
3. Training and Experience for Proposed Authorized User (continued)
Supervised Work Experience. (continued)b.
For 35.500 uses only, stop here. For 35.100 and 35.200 uses, skip to and complete Part II Preceptor
Attestation.
c. For 35.590 only, provide documentation of training on use of the device.
d.
No
Yes
No
Yes
No
Yes
No
Yes
Calculating, measuring, and safely
preparing patient or human research
subject dosages
No
Yes
NRC FORM 313A (AUD) (06-2016)
NRC FORM 313A (AUD)
(06-2016)
U.S. NUCLEAR REGULATORY COMMISSION
AUTHORIZED USER TRAINING AND EXPERIENCE AND PRECEPTOR ATTESTATION (continued)
PART II – PRECEPTOR ATTESTATION
PAGE 4
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. (Not
required to meet training requirements in 35.590)
First Section
Check one of the following for each use requested:
For 35.190
Board Certification
I attest that
Name of Proposed Authorized User
has satisfactorily completed the requirements in
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
Name of Proposed Authorized User
has satisfactorily completed the 60 hours of training and
experience, including a minimum of 8 hours of classroom and laboratory training, 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
Board Certification
I attest that
Name of Proposed Authorized User
has satisfactorily completed the requirements in
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 35.200.
OR
Training and Experience
I attest that
Name of Proposed Authorized User
has satisfactorily completed the 700 hours of training
and experience, including a minimum of 80 hours of classroom and laboratory training, 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 35.200.
Second 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
Name of Preceptor
Signature
Telephone Number Date
License/Permit Number/Facility Name
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."
NRC FORM 313A (AUD) (06-2016)
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Nrc Form 313a Aud (Saint Louis University)

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Completed 21 July 2020

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