~U 

UNITED STATES 

SNRC NUCLEAR REGULATORY COMMISSION

Protecting People and the Environment

Training and Experience

(T&E). Requirements

April 29, 2008

Douglas F. Eggli, M.D.

Nuclear Medicine Physician

Advisory Committee on the Medical Uses

of Isotopes (ACMUI)
ACMUI Recommendation

* Nuclear Regulatory Commission (NRC) staff

should remove the attestation requirement for

board certified individuals

* NRC staff should rewrite the attestation

requirement for individuals seeking authorization

under the alternate pathway

- The rewritten attestation should not include

the word "competency" but should instead

read "has met the training and experience

requirements."

2
The Competency Problem

*Competency is difficult to quantitatively define

*Competency cannot be taught

*Competency cannot be reliably measured

*Competency cannot be guaranteed

- How long does a competency attestation last?

*Competency has legal liability risk

-Preceptors are reluctant to' accept this risk

3
Board Certification

* Approved boards have agreed to meet NRC

requirements.

- Certification processes are reviewed and

recognized by NRC

* A curriculum and a body of knowledge can be

defined

* Progress toward meeting defined requirements

can be measured

* Board certification indicates that T & E

requirements have been met.

- Maintenance of Certification provides ongoing

evidence of current knowledge

* An additional attestation is superfluous

4
Preceptor Attestation

" Training to board certification is a collective

process.

- The collective judgment of an entire residency

program and the board examination process

are employed

" Preceptor attestation is an individual process

- An individual preceptor typically would provide

only a small portion of the training and

experience

- Because of the liability, preceptors are

reluctant to attest to training and experience

not personally provided

5
Preceptor Attestation

* The problem is particularly acute for Radiation

Safety Officers (RSO)

- Any one license recognizes only one RSO

- The regulation requires a RSO preceptor for a

RSO candidate

RSO's are reluctant to precept individuals they

did not personally train

6
Preceptor Attestation

* Although the regulation has been

interpreted to allow a preceptor

to attest to "indirect knowledge"

of a candidate's training and

experience, the legal liability risk

discourages this in practice

7
ACMUI Recommendation

* ACMUI recommends that NRC

staff should remove the

attestation requirement for board

certified individuals

8
Alternate Pathway

" Most boards provide final certification following

residency

- The range is a few months to 2 years

- American Board of Radiology is the only board

that certifies residents by the completion of

residency

* This will change for residents entering

training no later than 2010

" This forces boards to train to the "Alternate

Pathway" requirements

- This was not the intent of the regulation

9
Alternate Pathway cont.

* Although the alternate pathway was

designed to allow individuals who are

not (or not yet)'certified by a

recognized board to achieve

authorized user status, the current

regulation functionally limits the

availability of the pathway

10
Alternate Pathway cont.

9 Preceptors are reluctant to write

Alternate Pathway preceptor

statements in part because of the

attestation of "competence"

*The result will be that graduates of

residency programs will be unable to

become authorized users for a variable

am .ount of time after completion of

residency

11
Alternate Pathway cont.-

* Graduates may be unable to work until

they achieve board certification

" Small and rural practices will be most

disadvantaged

" Diagnostic nuclear medicine studies

may be unavailable in some areas

12
ACMUI Recommendation on

Alternate Pathway

" ACMUI recommends that the standard used be

both measurable and achievable

- ACMUI recommends that the phrase "has met

the training and experience requirements"

replace the term "competency"

* This will permit graduates to practice clinical

nuclear medicine between completion of

residency and board certification

13
Summary

* ACMUI believes that the T&E requirements in 10

CFR Part 35 have had unintended consequences

for residency training

* If not corrected, those consequences will ripple

through to both the clinical practice and

availability of clinical nuclear medicine

* ACMUI believes that its recommendations will

mitigate the unintended adverse impact on both

the regulated community and the general public

14
Acronyms

" ACMUI - Advisory Committee on the

Medical Uses of Isotopes

" CFR- Code of Federal Regulations

" NRC- Nuclear Regulatory Commission

" RSO - Radiation Safety Officer

" T&E- Training and Experience

15
U..NRC UNITED STATES NUCLEAR REGULATORY COMMISSION

Protecting People and the Environment

Increased Controls &

Fingerprinting Orders

April 29, 2008

Richard J. Vetter, Ph.D.

Radiation Safety Officer (RSO) Representative

Advisory Committee on the Medical Uses of Isotopes

(ACMUI)
Issues with Fingerprinting Orders

" Cost to licensee

" Lack of justification

* Grandfathering of Trustworthy &

Reliable (T&R) employees

* Limited opportunity for ACMUI

input

2
Cost to Licensee

Fingerprinting costs for one licensee:

* Local fingerprinting: <$50

* NRC/FBI costs: $36

* Total per-employee <$90

* 400 employees @ $90: $36,000

3
Cost to Licensee cont.

Indirect costs (Salary &Benefits):

* Time away from work - 1 hour

* 400 lab employees @ $50

• Security (400 @ 0.25 hr)

* Health Physics (set-up, training,

communications, etc: 0.2 FTE)

$56

$20,000

$5000

$15,000

Total: $40,000

4
Cost to Licensee cont.

* Fingerprinting

" Indirect

• Total

$36,000

$40,000

$76,000

5
Cost to Licensee cont.

Budget: Outside Services

" Annual license fees

• Dosimeter service

" Fingerprinting

$29,000

$33,000

$76,000

* If margin = 2.4%, gross needed = $3.2M

" Repeat every 5 years??

6
Justification

" Unfunded mandate

" RSO must justify to management

" Not -based on a vulnerability analysis

* No security issues with irradiators

* Nuclear Materials Events Database (NMED): I

"lost" irradiator - 420 Ci; high school license

expired 1986; inspection in 2000 failed to

locate source (oversiqht).

7
Example

Researcher must be fingerprinted

* > 400 scientific publications

* Grants total $ millions

* Current research:

- collagen induced arthritis

- HLA-B27 gene linked spondyloarthropathies

- experimental autoimmune encephalomyelitis

- allergen induced asthma

- diabetes

- lupus

- coeliac disease

8
Grandfathering of T&R Employees

* Researcher should be grandfathered

* Current users passed T&R

determination

* Fingerprint requirement disqualifies

them

* All current users should be

grandfathered

9
ACMUI Input

" This is first opportunity for ACMUI to

address fingerprinting with The

Commission

• Email to NRC Staff (5/23/07)

" Ralph Lieto & I met with NRC

Implementation Task Force (7/31/07);

briefed ACMUI by conference call

8/15/07

10
Conclusions

" Initial costs significant

" Lack of justification for Category 2

sources

" T&R employees should be

grandfathered

" Lack of ACMUI input

11
I $

Acronyms

" ACMUI - Advisory Committee on the Medical

Uses of Isotopes

" FBI - Federal Bureau of Investigation

* NMED - Nuclear Materials Events Database

* NRC - Nuclear Regulatory Commission

* RSO - Radiation Safety Officer

* T&R - Trustworthy and Reliable

12