ML20211K407

From kanterella
Revision as of 11:30, 6 May 2021 by StriderTol (talk | contribs) (StriderTol Bot insert)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search
Training & Experience
ML20211K407
Person / Time
Issue date: 09/30/1997
From:
NRC COMMISSION (OCM)
To:
References
RULE-PR-35-MISC NUDOCS 9710090230
Download: ML20211K407 (23)


Text

f '

'i-September 30,1997 TRAINING AND EXPERIENCE NOTE Following Commission approval of the staffs program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language,' using a modality-based approach. As directed by the Commission, the staff ,

has developed alternatives, with draft rule text, for the more significant issues associated with the regulation of the medical use of byproduct material. These altematives to regulation in specific areas are intended to help focus the discussion during the NRC's public meetings and the meetings with medical professional societies during the Fall of 1997 and to assist the staff in developing the proposed rule language.

The alternatives represent a broad range of possibilities and are being provided to stimulate input from members the public in an effort to encourage all interested parties to provide input into the dev_elopment of the revised regulation. . The NRC staff

has not selected any attemative at this time, and is open to additional attematives which might be proposed that are consistent with the guidance provided by the Ccmmission.

l c

g(f3d /b eDi&L t/se e

?

.14,D b , y ( (TV 9710090230 970930

~

<M EE"mEE eon W@@@@ ,,3 y . ,r

~

,
' ry ?'

- a a_ . , , - - . . , - - - - . = . , _ _. s . _ _ __.-- _.-..e l

9/29/97 PART 35 TRAINING AND EXPERIENCE

, Summarv of Alternatives - Authorized Urar

1. Status quo (i.e., M.D + Board certification or specified number of hours of training and experience).
2. M.D. + Board certification or specified number of hours of training and experience (with 4 a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will no' be listed in the rule, but insteaa will be a certification that is approved by the NRC.
3. M.D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.
4. M.D. only.

! 5. M.D. + exam.

6. M.D. + exam + clinical experience.

NOTES The Alternatives represent various combinations of training and experience criteria that could be used to demonstrate that an authorized user can receive, possess, use, and transfer radioactive material consistent with radiation safety practices and in accordance with the regulations.

4 These key elements are listed below with a reference to the Aitemative that '.7corporates the

, element.

1. Is it necessary to state the need for clinical experience in the training and experience requirement? If yes, sne Attematives 1,2,3, end 6.
2. How should a potential authorized user demonstrate that they have obtaine.d knowledge about the safe handling of radioactive material?
a. If by industry certification (e.g., American Board of Nuclear Medicine, American Board of Radiology, etc.), see Attematives 1,2, and 3.
b. If by radiation safety exam, see Attematives 3,5, and 6.

1

0 i

I e

ALTERNATIVES AVAILARLE FOR EACH MODALITY Altemative i Altemative 2 Altemative 3 Altemative 4 Altemative 5 Alternative 6 Low Cbse / / / / / /

Unsealed Diagnostic HG' Dose / / / No / /

Uc maled NA 4 Low Dose / / / No / /

Sealed Brachy-therapy Low Dosa / / / / / /

Sealed Diagnostic

_ Teletherapy / / / No / /

HDR / / / No / /

Gamma-Knife / / / No / /

Emerging / / / / / /

Technology 2

. . _. __.___ . _ . _ _ _ _ _ - _ , _ _ . . _ . _ _ . _ _ _ _ . _ . . _ _ . _ - . . _ . ~ _

.:. l ALTERNATIVE 1: Status quo (i.e., M.D. + Board certification or specified number of hours of

~

j; training and experience).

Pton i

1. More than one meant, to meet authorized user criteria.

2J Modality specific.

3. Easy to use if board certified by a board listed or if have completed a training program.
4. Assures that user has radiction safety training if training hour option is Ngued.

l-1- 5. Has a clinical experience component.

l h

} 1. Reference to a training program that is not in existence (e.g., 35.910(c) - six month training r F program).

i l 2. Limits approval to boards specifically listed and must amend regulations to add or delete a

board.

i 3. Training hours required may not accurately reflect the risk of the modality (i.e., not risk I based).

l- 4, No process developed for periodic review and assurance of certifying board standing.

t- 5. _NRC must review / accept any certifying boards not listed.

i

6. - Requiring hours in radiation safety training does not assure understanding of radiation safety, j

Current Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a)is certified by:

(1) The American Board of Nuclear Medicine; (2) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; . _ _ _

(3) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

- (4) The American Osteopathic Board of Radiology after 1984; or 3

1 I _- -_ , - . _

_ . . . _ . . - . . . . . . . _ . . .- . . - - . _ . _ = .

~

(b) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as

- follows:

(1) 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of classroom and laboratory training that includes:

- (i) Radiation physics and instrumentation;

. (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; and

., (2) Supervised clinical experience under the supervision of an authorized user at a medical .

i- institution that includes; (1) Use of iodine 131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in 10 individuals; and (ii) Use of lodine-131 for treatment of thyroid carcinoma in 3 individuals.

1 a  !

l 4

I

)

i i

F 4

l ALTERNATIVE 2: M.D, + Board certification or specified number of hours of training and-experience (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience). Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

EIQ1

1. More than one means to meet authorized user criteria.
2. Modality specific.

< 3. Easy to use if board certified or if have completed a training program.

4. Emphasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the risk of the modality increases).

S. Board changes do not require rulemaking.

6. Assures that user has radiation safety training if training hour option is pursued.-
7. - Clinical experience component is included.

C908

1. ' NRC must review / accept certifying board.
2. A mechanism must be developed to notify the public of the NRC accepted boards.

' 3. No process developed for periodic review and assurance of certifying board standing.

4. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) is certified by a medical specialty board whose certification process includes all of the L training and experience requirements in Section 35.930(b) and whose certification has been

!- - accepted by the NRC; or -

(b) Has completed hours of training (e.g.,120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals; and has had supervised radiopharmaceutical administration experience.

(1) The classroom and laboratory training shall include:

5-

l (1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology.

(2) The supervised work experience under the supervision of an authodzed user shall include:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the I related radiation surveys;

{

(ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper i operation of survey meters; (iii) Calculating and safety preparing patient or human research subject dosages; (iv) Using administrative controls to prevent the misadministration of byproduct material; and

- (v) Using procedures te contain spilled byproduct material safely and using proper decontamination procedures.

(3) The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a medical institution shall include:

(1) Oral administration in 10 individuals of iodine-131 or diagnostic studies (involving dosages of sodium iodide 1-131 in quantities greater than 30 microcuries) or for treatment of hyperthyroidism or cardiac dysfunction; or (ii) Parenteral administration in 3 individuals of: phosphorus-32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium.89 or samarium-153 for treatment of bc.ie metastasis; and (iii) Oral administration in 3 individuals of iodine-131 for treatment of thyroid carcinoma.

6

l ALTERNATIVE 3: M.D. + Board certification or specified number of hours of training (with a change in the number of hours to focus on radiation safety, with minimal requirements for clinical experience) + exam. Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

P. Inn

1. More than one means to meet authorized user criteria.
2. Modality specific.
3. Easy to use if board certified.
4. Emphasis on radiation safety for the number of hours of training required (i.e., risk based if the number of hours required increases as the risk of the modality increases).
5. Board changes do not require rulemaking, i 6. Standardized method for testing a baseline of awareness / knowledge.

l 7. Added assurance that tested individual is aware of radiation safety issues (i.e., baseline).

8. Clinical experience component is included.

L CQD1

1. NRC must review / accept certifying board.
2. A mechanism must be developed to notify the public of the NRC accepted boards.
3. Process required for periodic review and assurance of cert;fying board requirements.
4. Resource intensive to develop and administer exam and maintain testing program.
5. Added expense to person taking exam (e.g., cost to travel to exam location).

Draft Rule __Tsu(1 The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician who:

(a) is certified by examination by a medical specialty board whose certification process includes all of the training and experience requirements in Section 35.930(b) and whose certification hac been accepted by the NRC; or (b) Has completed hours of training (e.g.,120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable 7

to the use of therapeutic radiopharmaceuticals; has had supervised radiopharmaceutical -

administration experience; and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or

' an organization or entity approved by the Commission.

' (1) The classroom and laboratory training shall include:

- (1) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology, (2) The supervised work experience under the supervision of an authorized user shall include:

(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys; (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper L

operation of survey meters;

- (iii) Calculating and safely preparing patient or human research subject dosages; (iv) Using administrative controls to prevent thc misadministration of byproduct material; and (v) Using procedures to contain spilled byproduct material safely and using proper ,

decontamination procedures.

(3) The supervised radiopharmaceutical adminirtration experience under the supervision of an authorized user at a medical institution shallinclude:

(l) Oral administration in 10 individuals of iodine-131 or diagnostic studies (involving dosages of sodium iodide 1 131 in quantities greater than 30 microcuries) Or for treatment of hyperthyroidism or cardiac dysfunction; or

- (ii) Parenteral administrat!on in 3 individuals of: phosphorus 32 for treatment of myeloproliferative disorders or intracavitary cancer; or strontium-8g or samarium-153 for treatment of bone metastasis; and (iii) Oral adrtaistration in 3 individuals of iodine-131 for treatment of thyroid carcinoma, 8-

f ,

-- i

~

' ALTERNATIVE 4: M.D. only. '

tj Ema-- -- --

1. No NRC specified training required to practice medicine using radioactive material.
2. Easier to approve authorized users.

' 3. L Licensee is given complete latitude to review and determine the radiation safety and -

modality specif.c qualifications of a practitioner.

~

4. Supports a high y performance based approach.

g 1

1. May not accurately reflect risk of modaldy (i.e., not risk-based).
2. No assurance that user has received radiation safety training.

3.1 No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk-based).

Draft Rule Text:

The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a_ physician.

t9

' 7. :

Al.TERNAI!VEA M D.'+ exam.

2001:

1.f Modality specific if tailor test to each modality.

2. ' Standardized method for testing a baseline of awareness / knowledge.
3. Added assurance that tested individual is aware of radiation safety issues (i.e., baseline). -

- 4. No NRC specified training required to practice medicine using radioactive material.

i CODE

, 1. Resource intensive to develop and administer exam and maintain testing program.

2. Added expense to person taking exam (e.g., cost to travel to exam location).
3. No specific clinical experience required. This may not accurately reflect the risk of the modality (i.e., not risk-based). 4
4. - Relies on exam results to show that individual has received appropriate radiation safety

_ training.

Draft Rule Text The licensee shall require the authorized user of radiopharmaceuticals in Section 35.300 to be a physician and has demonstrated sufficient knowledge in radiation safety commensurate

.with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

10

7

,a1 _

ALTERNATIVE 6: M.D. + exam + clinical experience.-

-- gggg :

L 1. Modality specific if tailor test and experience to each modality.

2; Standardized method for testing a baseline _of awreness/ knowledge.

3. Added assurance that tested individual is aware of radiation safety issues (i.e., baseline).

l

- 4. _ Clinical experience component is included.

v CDDE

1. Resource intensive to develop and administer exam and maintain testing program. .

l L 2. Added expense to person taking exam (e.g., cost to travel to exam location).

3. Relies on exam results to show that individual has received sopropriate radiation safety -

training.

Qtatt Rule Text The $censee shall require the authorized user of radiopharmaceuticals in Section 35.300 to i

.be a physician who;

(a) Has demonstrated sufficient knowledge in radiation safety commensurate with the use i requested by passing an examination given by the Commission or an organization or entity approved by the Commission; and

. (b) Has had supervised radiopharmaceutical administration experience. The supervised radiopharmaceutical administration experience under the supervision of an authorized user at a :

- medical institution shall include: '

- (1) Oral administration in 10 individuals of iodine-131 or diagnostic studies (involving

dosages of sodium lodide I-131 in quantities greater than 30 microcuries) or for treatment of

' hyperthyroidism or cardiac dysfunction; or- _

(2) Parenteral administration in 3 individuals of; phosphorus 32 for treatment of

myeloproliferative disorders or intracavitary cancer; or strontium-89 or samarium-153 for treatment of bone metastasis; and (3) Oral administration in 3 individuals of iodine-131 for treatment of thyroid carcinoma.

11

l AUTHORl7.ED USER OVERVIEW ALTERNATIVES KEY ITEMS FOR CONSIDERAllON 1 2 3 4 5 6 More than one means to meet training and experience X X 4X criteria.  ;

Modality specific. X X X X X Easy to use if beard certified. X X X Emphasis on radiation safety training when training and X X experience required, (i.0,, risk based)

Board changes do not re quire rulemaking, X X i Standardized method for testing a baseline of training and X X X experience, Licensee given complete latitude to review and approve X users.

Resource intensive to develop and administer exam. .X X X Added expense to person aking exam. X X X f

Added assurance that tected individualis aware of radiation X X X safety issues.

Clinical experience comp.o lent included. X X X X 12

{

)

\ - .

Summarv of Alternatives - Radiation Safety Officer

1. Status quo (i.e., Board certification or specified number of training hours along with one

. year of training under an RCO or identified as an authorized user on a license).

2. Board certification by a %ard approved by the NRC or specified number of training hours to-.

Include experience with the types and forms of radioactive material to be used at the facility.

Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

6

3. Board certification by a board approved by the NRC or specified number of training hours to i include experience with the types and forms of radioactive material to be used at the facility i

+ exain. Note, the specific board certifications will not be listed in the rule, but instead will  ;

be a certification that is approved by the NRC. 1

4. Exam only.
5. One year of full-time experience at a medicalinstitution under the supervision of a radiation safety officer + exam.

l 13

\

1 ALTERNATIVE 1: Status quo (i.e., Board certification or specified number of training hours along with one year of training urder an RSO or identified as an authorized user on a license).

Erss

1. More than one means to neet RSO criterie.
2. Easy to use if board certified by a board listed or if named as an authorized user on a license.
3. Assures that RSO has radiation safety training if training hour option is pursued.

QQui

1. Not risk-based. Same training requirement regardless of level of use, i
2. Assumes that an authorized user has suffdent radiation safety training.
3. Limits to specific boards listed in the rule and nmst amend regulations to add or delete boards.
4. Number of hours specified may not eccurately reflect the risk of each modality.
5. NRC must review / accept any certifying boards not listed.
6. Requiring hours in radiation safety training does not assure understanding of radiation safety.

Current Rule Text:

The licensee shall requir0 an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(a) is certified by' (1) American Board of Health Physics in Comprehensive Health Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or 14

-e.

(b) Has had classroom and laboratory training and experience as follows:

- (1) 200_ hours of classroom and laboratory training that includes:

(I) Radiation physics and instrumentation;

. (ii) Radiation protection;

- (iii) Mathematics pertaining to the use and measurement of radioactivity; l (iv) kadiation biology; and (v) Radiopharmaceutical chemistry; and _

_ (2) One year of full time experience as a radiation safety techat logist at a medical institution -

l -- under the supervision of the individualidentified as the Radiation $ fety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; or

- (c) Be an authorized user identified on the licensee's license.

4 1

l 15

=,_

ALTERNATIVE 2i Board certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used

- at the facility. Note, the specific board certifications will not be listed in the rule, but inst (ad will be a certification that is approved by the NRC.

E.tDa

-1. More than one means to meet RSO criteria.

2, - Modality specific if experience and training hours are tai *ored for each modality.

3. Easy to use if board certifed,
t. . Board changes do not require rulemaking.
5. Assures that RSO has radiation safety training if training hour option is pursued.

o gang

1. NRC must review / accept certifying board.'
2. A mechanism must be developed for notifying the public of NRC accepted boards.
3. To approve an authorized user to be RSO, the AU must meet the specifed RSO criteria.

)

4.- Requiring hours in radiation safety training does not assure understandinhof radiation -

safety.

- Draft Rule Text:

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

._ _(a) Is' certified by a specialty board whose certification process includes all of the training and experience requirements in Section 35.900(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the type and forms of radioactive material to be usedc

~ (1) The classroom and laboratory training shall include:

(1) Radation physics and instrumentation;

-(ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; (iv) Radiation biology;

(v) Radiopharmaceutical chemistry.

(2) The st pervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:

(I) Authorizing the purchase of radioactive material; (ii) Receiving and opening packages of radioactive material; (iii) Storing radioactive material; (iv) Keeping an inventore record of radioactive material; (v) Using radioactive matmial safely; (vi) Taking emergency action if control of radioactive materialis lost; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of radioactive material; and (x) Training personnel who work in or frequent areas where radioactive material is used or stored.

i 17

ALTERNATIVE 3: Poard certification by a board approved by the NRC or specified number of training hours to include experience with the types and forms of radioactive material to be used l at the facility + exam.- Note, the specific board certifications will not be listed in the rule, but instead will be a certification that is approved by the NRC.

P_ ton -

1. More than one means to meet RSO criteria.

l

2. Modality specific if experience and training hours are tailored for each modality.
3. Easy to use if board certified.
4. Board changes do not require rulemaking.
5. Standardized method for testing a baseline of awareness / knowledge.
6. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

CQDa

1. . NRC must review / accept certifying board.
2. A mechanism must be developed for notifying the public of NRC accepted boards.
3. To approve an authorized user to be RSO, the AU must meet the specified RSO criteria.
4. Resource intensive to develop and administer exam and maintain testing program.
5. Added expense to person taking exam (a.g., cost to travel to exam location).-

Draft Rule Text:

The licensee shall require an individual fulfilling the recponsibilities of the Radiation Safety Officer to bc an individual who:

(a) is certified by examination by a specialty board whose certification process includes all of the training and experience requirements in Section 35.900(b) and whose certification has been accepted by the NRC; or (b) Has completed hours of training (e.g.,200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br />) that includes classroom and laboratory training and supervised work experience, in basic radioisotope handling techniques applicable to the type and forms of radioactive material to be used; and has demonstrated sufficient knowledge in radiation safety commensurate with the use requested by passing an examination given by the Commission or an organization or entity approved by the Commission.

(1) The classroom and laboratory training shall include:

18

e (1) Radiation physics and instrumentation; (ii) Radiaticr. protection; (iii) Mathematics pertaining to the use and measurement of radiosctivity; -

- (iv) Radiation biology; (v) Radiopharmaceutical chemistry, (2) The supervised work experience, under the supervision of a Radiation Safety Officer on a Commission or Agreement State license that authorizes the use of byproduct material similar to the use requested shallinclude:

(i) Authorizing the purchase of radioactive material; (ii) Receiving and opening packages of radioactive material; (iii) Storing radioactive material; (iv) Keeping an inventory record of radioactive material; (v) Using radioactive material safely; (vi) Taking emergency action if control of radioactive material is lost; (vii) Performing periodic radiation surveys; (viii) Performing checks of survey instruments and other safety equipment; (ix) Disposing of radioactive material; and (x) Training personnel who work in or frequent areas where radioactive material is used or stored.

i 4 -

19

c.)

c ALTERNATIVE 4: Exam only.

Erga--

1. Modality specific if tailor test to each modality.
2. Standardized method for testing a baseline of awareness / knowledge.

~

3. Added assurance that tested individualis aware of radiation safety issues (i.e., baseline).

l C9Da l- 1;- Resource intensive to develop and administer exam and maintain testing program.-

I

2. Added expense to person taking exam (e.g., cost to travel to exam location).

' 3. Relies on exam results to show that individual has received appropriate radiation safaty training.-

4. To apprcve an authorized user to be RSO, the AU must meet the specified RSO criteria.

Draft Rule Text:

I -

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who has demonstrated sufficient knowledge in radiation safety -

commensurate with the use requested by passing an examination given by the Commission or

.an organization or entity approved by the Commission.

l

-l 20

sf

_4 ALTERNATIVE 5. One year of full-time experience at a medicalinstitution under the supervision of a radiation safety officer + exam.-

ECQA -

1. Assures that RSO has radiation safety training at a medicalinstitution.

I 2 Standardized method for testing a baseline of awareness / knowledge.

3. Added assurance that tested individual is aware of radiation safety issues.

CDDR

1. Not risk-based. Same training requirement regardless of level of use.-
2. Amount of time specified may not accurately reflect the risk of each modality.
3. _ Resource intensive to develop and administer exam and maintain testing program.
4. Added expense to person taking the exam.

Draft Rule Text-1 i

The licensee shall require an individual fulfilling the responsibilities of the Radiation Safety Officer to be an individual who:

(a) Has completed one year of full time experience at a medical institution under the supervision of the individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material and,-

(b) Has demonstrated sufficient knowledge in the radiation safety commensurate with the ,

use requested by passing an examination given by the Commission or an organization or entity -

approved by the Commission.

}

21

J Summarv of Alternatives . Authorized Physicist and Author! zed Nuclear Pharmacist i;

Attematives for training and experience are similar to the alternatives provided for the radiation safety officer, except for the text discussing an authorized user requesting to be listed as a radiation safety officer. However, care must be taken to ensure that the training and experience for physicists is commensurate with the type of physics performed.

1 l

t 22

. -