ML072270127 

 UNITED STATES 

 NUCLEAR REGULATORY COMMISSION 

 OFFICE OF FEDERAL AND STATE MATERIALS 

 AND ENVIRONMENTAL MANAGEMENT PROGRAMS 

 WASHINGTON, DC 20555-0001 

 

 December 14, 2007 

NRC INFORMATION NOTICE 2007-38: ENSURING COMPLETE AND ACCURATE 

INFORMATION IN THE DOCUMENTATION OF 

TRAINING AND EXPERIENCE FOR INDIVIDUALS 

SEEKING APPROVAL AS MEDICAL 

AUTHORIZED USERS 

ADDRESSEES

All U.S. Nuclear Regulatory Commission (NRC) medical use licensees and NRC master 

materials licensees. All Agreement State Radiation Control Program Directors and State Liaison 

Officers. 

PURPOSE

The NRC is issuing this information notice (IN) to inform addressees of the importance of 

verifying the completeness and accuracy of information provided by individuals seeking 

authorization for medical use from the NRC under the alternate pathway. Approval under the 

alternate pathway is based on an evaluation of an individual=s training and experience against 

the requirements specified in Title 10 of the Code of Federal Regulations Part 35, “Medical Use 

of Byproduct Material,” (10 CFR Part 35) for the particular authorization being sought. 

Recipients should review the information for applicability to their facilities and consider actions, 

as appropriate, to ensure the completeness and accuracy of the information provided in support 

of individuals seeking authorization under the alternate pathway. However, suggestions 

contained in this IN are not new NRC requirements; therefore, no specific action or written 

response is required. The NRC is providing this IN to the Agreement States for their information 

and for distribution to their medical licensees as appropriate. 

DESCRIPTION OF CIRCUMSTANCES

Recently, NRC has identified several instances where licensees have provided documentation 

of training and experience for proposed authorized individuals (i.e., physician authorized users 

(AUs) or authorized medical physicists (AMPs)) that contained false or inaccurate information. 

In each case, the proposed authorized individuals sought authorization by the alternate pathway. 

In the first case, a licensee submitted an amendment request to add a number of medical 

physicists to its license as AMPs and included a preceptor statement for a Junior Medical 

Physicist who was seeking authorization under the alternate pathway. An AMP who was listed 

on the licensee=s license completed the Junior Physicist=s preceptor statement. Based on an 

investigation by the NRC Office of Investigations (OI), the NRC determined that the preceptor 

statement was inaccurate in that it documented dates of clinical training that exceeded the dates 

of actual training received by the Junior Medical Physicist. The NRC concluded that the actions 

of the preceptor AMP were deliberate, in that he knew that the preceptor statement was 

inaccurate at the time it was submitted to the licensee and then subsequently to the NRC. The 
IN-2007-38 

Page 2 of 3 

licensee is responsible for the acts and omissions of its employees and contractors and their 

employees, and thus the agency determined that the submission of the inaccurate information 

by the licensee to the NRC was a deliberate violation of 10 CFR 30.9(a). This section of the 

regulations requires, in part, that information provided to the Commission by a licensee or an 

applicant for a license shall be complete and accurate in all material respects. As a result, the 

NRC cited the licensee for a Severity Level III violation of 10 CFR 30.9(a) and levied a civil 

penalty of $3,250.00. Severity Level III violations are causes for significant regulatory concern. 

Furthermore, the NRC determined that the AMP, who was a contractor or employee of the 

licensee, deliberately provided inaccurate information to the licensee that caused the licensee to 

violate NRC regulations. Therefore, the agency issued the AMP a Severity Level III Notice of 

Violation for violation of 10 CFR 30.10, ADeliberate misconduct.@ This regulation requires, in 

part, that an employee, contractor (including a consultant or supplier), or subcontractor of a 

licensee or applicant for a license may not engage in deliberate misconduct that causes a 

licensee or applicant for a license to violate any requirement, and may not deliberately submit to 

the NRC, the licensee, or the license applicant, information that the person submitting the 

information knows to be incomplete or inaccurate in some respect material to the NRC. 

In the second case, involving the same AMP and Junior Medical Physicist and the same 

inaccurate preceptor statement, a different licensee submitted an amendment request to add the 

Junior Medical Physicist to its license. However, in this case, before submitting the amendment 

request to the NRC, the licensee=s Radiation Safety Officer (RSO) conducted interviews with the 

AMP and the Junior Medical Physicist in an attempt to verify the accuracy of the information 

contained in the preceptor statement. Both the AMP and the Junior Medical Physicist informed 

the RSO that the information in the preceptor statement was accurate. The licensee 

subsequently submitted the amendment request with the inaccurate preceptor statement. As in 

the first case, the NRC concluded that the actions of the AMP and the Junior Medical Physicist 

were deliberate. However, because the licensee=s RSO did attempt to verify the accuracy of the 

information contained in the preceptor statement by interviewing both individuals, before 

submitting it to the NRC, the agency classified the violation of 10 CFR 30.9(a) as a Severity 

Level IV violation and did not propose a civil penalty. Severity Level IV violations are less 

significant than Severity Level III violations. The NRC determined that the AMP and the Junior 

Medical Physicist, who were both contractors or employees of a licensee, deliberately provided 

materially inaccurate information to the licensee and caused the licensee to violate 10 CFR 

30.9(a). The AMP and the Junior Physicist both received Severity Level III Notices of Violation 

for violation of 10 CFR 30.10. 

In the third case, a diagnostic nuclear medicine licensee provided a proposed AU with a copy of 

a sample preceptor letter that contained blank spaces to be completed by the proposed AU and 

a preceptor AU. The blank spaces were for the documentation of the number of hours of 

supervised clinical and work experience in diagnostic nuclear medicine received by the 

proposed AU and for the signature of the supervising preceptor AU. The blank spaces of the 

preceptor letter were filled in, the letter was signed by the preceptor AU and the proposed AU, 

and the letter was returned to the licensee. The licensee did not question the authenticity or 

accuracy of the number of hours of supervised clinical and work experience identified in the 

preceptor letter. The licensee submitted a license amendment application to add the proposed 

AU to its license and included the preceptor letter as supporting documentation. The NRC 

approved the amendment and added the physician to the license as an AU. However, based on 

an OI investigation, the NRC determined that the preceptor letter was materially inaccurate. 

Specifically, the preceptor admitted to signing the letter without reading the details and 

acknowledged that the number of hours of supervised clinical work experience was inaccurate. 

As a result, the AU was subsequently removed from the license. The NRC issued separate 
IN-2007-38 

Page 3 of 3 

Severity Level III Notices of Violation to the licensee and proposed AU for having violated 10 

CFR 30.9(a). 

DISCUSSION

In the first and third cases described above, the licensees did not fulfill their responsibility to take 

reasonable steps to verify that the proposed AU or AMP had actually received the training and 

experience claimed before submitting their license amendment applications to the NRC. NRC 

regulations in 10 CFR 30.9(a) require, in part, that information provided to the Commission by a 

licensee or applicant for a license shall be complete and accurate in all material respects. It is 

the licensee=s and applicant=s responsibility to ensure the completeness and accuracy of all 

information it provides to the NRC. Licensees and applicants for a license should consider 

contacting preceptors as well as training program directors and continuing medical education 

providers to verify that the training and experience submitted by proposed individuals (i.e., AUs, 

AMPs, authorized nuclear pharmacists and radiation safety officers) is accurate and 

commensurate with the training and experience required by the applicable sections of 10 CFR 

Part 35. 

Whether or not a licensee is aware of the incompleteness or inaccuracy of the information it 

submits to the NRC, a violation of 10 CFR 30.9, ACompleteness and accuracy of information,@

occurs when inaccurate or incomplete information is submitted because licensees are 

responsible for the completeness and accuracy of the information they submit to the NRC. In 

addition, if the licensee willfully submits inaccurate or incomplete information to the NRC, or if 

inaccurate or incomplete information submitted to the NRC is determined to have been willfully 

supplied to the licensee by an employee, contractor, consultant, supplier, or subcontractor of the 

licensee, the licensee=s violation of 10 CFR 30.9 may also be considered willful as the licensee 

is responsible for the conduct of its agents. Such violations will result in the consideration of 

escalated enforcement action against the licensee, including possible civil penalties. In addition, 

individuals who deliberately provide materially incomplete or inaccurate information to licensees 

or applicants for a license in connection with a submission to the NRC may be subject to NRC 

enforcement action under 10 CFR 30.10 and to criminal prosecution. 

CONTACT

This IN requires no specific action or written response. If you have any questions about the 

information in this notice, please contact the technical contact below, or the appropriate regional 

office. 

 /RA/ 

 

 Janet R. Schlueter, Director 

 Division of Materials Safety 

 and State Agreements 

 Office of Federal and State Materials 

and Environmental Management Programs 

Technical Contact: Tara Weidner, RI 

(610) 337-5272 

E-mail: tlw@nrc.gov 

Enclosure: 

ARecently Issued FSME/NMSS Generic Communications@
IN-2007-38 

Page 2 of 3 

Severity Level III Notices of Violation to the licensee and proposed AU for having violated 10 CFR 30.9(a). 

DISCUSSION

In the first and third cases described above, the licensees did not fulfill their responsibility to take 

reasonable steps to verify that the proposed AU or AMP had actually received the training and experience 

claimed before submitting their license amendment applications to the NRC. NRC regulations in 10 CFR 

30.9(a) require, in part, that information provided to the Commission by a licensee or applicant for a 

license shall be complete and accurate in all material respects. It is the licensee=s and applicant=s 

responsibility to ensure the completeness and accuracy of all information it provides to the NRC. 

Licensees and applicants for a license should consider contacting preceptors as well as training program 

directors and continuing medical education providers to verify that the training and experience submitted 

by proposed individuals (i.e., AUs, AMPs, authorized nuclear pharmacists and radiation safety officers) is 

accurate and commensurate with the training and experience required by the applicable sections of 10 

CFR Part 35. 

Whether or not a licensee is aware of the incompleteness or inaccuracy of the information it submits to the 

NRC, a violation of 10 CFR 30.9, ACompleteness and accuracy of information,@ occurs when inaccurate or 

incomplete information is submitted because licensees are responsible for the completeness and 

accuracy of the information they submit to the NRC. In addition, if the licensee willfully submits inaccurate 

or incomplete information to the NRC, or if inaccurate or incomplete information submitted to the NRC is 

determined to have been willfully supplied to the licensee by an employee, contractor, consultant, supplier, 

or subcontractor of the licensee, the licensee=s violation of 10 CFR 30.9 may also be considered willful as 

the licensee is responsible for the conduct of its agents. Such violations will result in the consideration of 

escalated enforcement action against the licensee, including possible civil penalties. In addition, 

individuals who deliberately provide materially incomplete or inaccurate information to licensees or 

applicants for a license in connection with a submission to the NRC may be subject to NRC enforcement 

action under 10 CFR 30.10 and to criminal prosecution. 

CONTACT

This IN requires no specific action or written response. If you have any questions about the information in 

this notice, please contact the technical contact below, or the appropriate regional office. 

Janet R. Schlueter, Director 

Division of Materials Safety 

 and State Agreements 

Office of Federal and State Materials 

 and Environmental Management Programs 

Technical Contact: Tara Weidner, RI 

(610) 337-5272 

E-mail: tlw@nrc.gov

Enclosure: 

ARecently Issued FSME/NMSS Generic Communications@ ML072270127

OFFICE DNMS DNMS DNMS RI/ORA RI/OI 

NAME TWeidner PHenderson BHolian DHolody EWilson 

DATE 

OFFICE RI/RC FSME/DMSSA FSME/DMSSA OE OGC FSME/DMSSA 

NAME KFarrar CFlannery SWastler NHiltion for 

C.CarpenterB

concurrence with 

FCameron JSchlueter 

DATE 8/13/07 08/14/07 10/26/07 12/11/07 12/14/07 

OFFICIAL RECORD COPY 
Enclosure 

IN-2007-38 

Page 1 of 2 

Recently Issued FSME/NMSS Generic Communications 

Date GC No. Subject Addressees 

02/02/07 IN-07-03 Reportable Medical Events 

Involving Patients Receiving 

Dosages of Sodium 

Iodide Iodine-131 Less Than the 

Prescribed Dosage Because of 

Capsules Remaining in Vials after 

Administration

All NRC medical use licensees and NRC 

master materials licensees. All 

Agreement State Radiation Control 

Program Directors and State Liaison 

Officers.

02/28/07 IN-07-08 Potential Vulnerabilities of TimeReliant Computer-Based Systems 

Due to Change in Daylight Saving 

Time Dates 

All NRC licensees and all Agreement 

State Radiation Control Program 

Directors and State Liaison Officers. 

03/13/07 IN-07-10 Yttrium-90 Theraspheres® and 

Sirspheres® Impurities 

All NRC medical licensees and NRC 

master materials licensees. All 

Agreement State Radiation Control 

Program Directors and State Liaison 

Officers. 

04/04/07 IN-07-13 Use of As-Found Conditions To 

Evaluate Criticality-Related 

Process Upsets at Fuel Cycle 

Facilities 

All licensees authorized to possess a 

critical mass of special nuclear material. 

05/02/07 IN-07-16 Common Violations of the 

Increased Controls Requirements 

and Related Guidance Documents 

All licensees who are implementing the 

NRC order imposing increased controls 

(EA-05-090), issued November 14, 2005, 

and December 22, 2005. 

07/19/07 IN-07-25 Suggestions from the Advisory 

Committee on the Medical Use of 

Isotopes for Consideration To 

Improve Compliance with Sodium 

Iodide I-131 Written Directive 

Requirements in 10 CFR 35.40 

and Supervision Requirements in 

10 CFR 35.27 

All NRC medical use licensees and NRC 

master materials licensees. All 

Agreement State Radiation Control 

Program Directors and State Liaison 

Officers. 

10/17/07 IN-07-35 Varian Medical Systems 

Varisource HDR Events: Iridium192 Source Pulled From Shielded 

Position 

All NRC medical use licensees and NRC 

master materials licensees authorized to 

possess or use a Varian Medical 

Systems VariSource High Dose Rate 

Remote Afterloader. All Agreement State 

Radiation Control Program Directors and 

State Liaison Officers 

03/01/07 RIS-07-03 Ionizing Radiation Warning 

Symbol 

All NRC licensees and certificate holders. 

 All Radiation Control Program Directors 

and State Liaison Officers. 

03/09/07 RIS-07-04 Personally Identifiable Information 

Submitted to the U.S. Nuclear 

Regulatory Commission 

All holders of operating licenses for 

nuclear power reactors and holders of 

and applicants for certificates for reactor 

designs. All licensees, certificate 

holders, applicants, and other entities 

subject to regulation by the NRC for the 

use of source, byproduct, and special 

nuclear material. 
Enclosure 

IN-2007-38 

Page 2 of 2 

Date GC No. Subject Addressees 

03/20/07 RIS-07-05 Status and Plans for 

Implementation of NRC Regulatory 

Authority for Certain Naturally 

Occurring and AcceleratorProduced Radioactive Material 

All NRC materials licensees, Radiation 

Control Program Directors, State Liaison 

Officers, and NRC=s Advisory Committee 

on the Medical Uses of Isotopes. 

04/05/07 RIS-07-07 Clarification of Increased Controls 

for Licensees That Possess 

Collocated Radioactive Material 

During Transportation Activities 

All NRC licensees issued the NRC=s 

order imposing increased controls and all 

Radiation Control Program Directors and 

State Liaison Officers. 

05/15/07 RIS-07-10 Subscriptions to New List Server 

for Automatic Notifications of 

Medical-Related Generic 

Communications, Federal Register

Notices and Newsletters 

All NRC medical-use licensees and NRC 

medical use licensees and NRC master 

materials licensees. All Radiation Control 

Program Directors and State Liaison 

Officers. 

06/27/07 RIS-06-27, 

Suppl. 1 

Availability of NRC 313A Series of 

Forms and Guidance for Their 

Completion 

All NRC medical use licensees, 

commercial nuclear pharmacy licensees, 

and NRC master materials licensees. All 

Radiation Control Program Directors and 

State Liaison Officers. 

08/31/07 RIS-07-13 Verification of the Authenticity of 

Materials Possession Licenses 

All NRC materials licensees. All 

Agreement State Radiation Control 

Program Directors and State Liaison 

Officers. 

06/05/07 RIS-07-14 NRC Regulatory Issue Summary 

2007-14 Fingerprinting 

Requirements for Licensees 

Implementing the Increased 

Control Order 

All NRC licensees that have received the 

Increased Controls (IC) requirements. All 

Agreement State Radiation Control 

Program Directors and State Liaison 

Officers. 

06/05/07 RIS-07-15 NRC Regulatory Issue Summary 

2007-15 Unescorted Access to 

Materials for Non-Manufacturer 

and Distributor Service Providers 

All NRC licensees that are nonmanufacturer and distributor (non-M&D) 

service providers. All Agreement State 

Radiation Control Program Directors and 

State Liaison Officers. 

10/04/07 RIS-07-22 Status Update for Implementation 

of NRC Regulatory Authority for 

Certain naturally-Occurring and 

Accelerator-Produced Radioactive 

Material 

All NRC materials licensees, radiation 

control program directors, State liaison 

officers, and the NRC’s Advisory 

Committee on the Medical Uses of 

Isotopes. 

10/04/07 RIS-07-23 Date for Operation of National 

Source Tracking System 

All licensees authorized to possess 

Category 1 or Category 2 quantities of 

radioactive materials. All Radiation 

Control Program Directors and State 

Liaison Officers. 

Note: A full listing of generic communications may be viewed at the NRC public Web site at 

http://www.nrc.gov/reading-rm/doc-collections/gen-com.