Information Notice 2007-38, Ensuring Complete and Accurate Information in the Documentation of Training and Experience for Individuals Seeking Medical Authorization Under the Alternate Pathway
| ML072270127 | |
| Person / Time | |
|---|---|
| Issue date: | 12/14/2007 |
| From: | Schlueter J NRC/FSME/DMSSA |
| To: | |
| References | |
| IN-07-038 | |
| Download: ML072270127 (6) | |
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 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 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 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 FCameron JSchlueter
C.CarpenterB
concurrence with
DATE 8/13/07 08/14/07 10/26/07 12/11/07 12/14/07 OFFICIAL RECORD COPY
Enclosure
IN-2007-38 Recently Issued FSME/NMSS Generic Communications
Date GC No. Subject
Addressees
02/02/07 IN-07-03 Reportable Medical Events All NRC medical use licensees and NRC
Involving Patients Receiving master materials licensees. All
Dosages of Sodium Agreement State Radiation Control
Iodide Iodine-131 Less Than the Program Directors and State Liaison
Prescribed Dosage Because of Officers.
Capsules Remaining in Vials after
Administration
02/28/07 IN-07-08 Potential Vulnerabilities of Time- All NRC licensees and all Agreement
Reliant Computer-Based Systems State Radiation Control Program
Due to Change in Daylight Saving Directors and State Liaison Officers.
Time Dates
03/13/07 IN-07-10 Yttrium-90 Theraspheres and All NRC medical licensees and NRC
Sirspheres Impurities 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 All licensees authorized to possess a
Evaluate Criticality-Related critical mass of special nuclear material.
Process Upsets at Fuel Cycle
Facilities
05/02/07 IN-07-16 Common Violations of the All licensees who are implementing the
Increased Controls Requirements NRC order imposing increased controls
and Related Guidance Documents (EA-05-090), issued November 14, 2005, and December 22, 2005.
07/19/07 IN-07-25 Suggestions from the Advisory All NRC medical use licensees and NRC
Committee on the Medical Use of master materials licensees. All
Isotopes for Consideration To Agreement State Radiation Control
Improve Compliance with Sodium Program Directors and State Liaison
Iodide I-131 Written Directive Officers.
Requirements in 10 CFR 35.40
and Supervision Requirements in
10/17/07 IN-07-35 Varian Medical Systems All NRC medical use licensees and NRC
Varisource HDR Events: Iridium- master materials licensees authorized to
192 Source Pulled From Shielded possess or use a Varian Medical
Position 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 All NRC licensees and certificate holders.
Symbol All Radiation Control Program Directors
and State Liaison Officers.
03/09/07 RIS-07-04 Personally Identifiable Information All holders of operating licenses for
Submitted to the U.S. Nuclear nuclear power reactors and holders of
Regulatory Commission 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 Date GC No. Subject
Addressees
03/20/07 RIS-07-05 Status and Plans for All NRC materials licensees, Radiation
Implementation of NRC Regulatory Control Program Directors, State Liaison
Authority for Certain Naturally Officers, and NRC=s Advisory Committee
Occurring and Accelerator- on the Medical Uses of Isotopes.
Produced Radioactive Material
04/05/07 RIS-07-07 Clarification of Increased Controls All NRC licensees issued the NRC=s
for Licensees That Possess order imposing increased controls and all
Collocated Radioactive Material Radiation Control Program Directors and
During Transportation Activities State Liaison Officers.
05/15/07 RIS-07-10 Subscriptions to New List Server All NRC medical-use licensees and NRC
for Automatic Notifications of medical use licensees and NRC master
Medical-Related Generic materials licensees. All Radiation Control
Communications, Federal Register Program Directors and State Liaison
Notices and Newsletters Officers.
06/27/07 RIS-06-27, Availability of NRC 313A Series of All NRC medical use licensees, Suppl. 1 Forms and Guidance for Their commercial nuclear pharmacy licensees, Completion 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 All NRC materials licensees. All
Materials Possession Licenses Agreement State Radiation Control
Program Directors and State Liaison
Officers.
06/05/07 RIS-07-14 NRC Regulatory Issue Summary All NRC licensees that have received the
2007-14 Fingerprinting Increased Controls (IC) requirements. All
Requirements for Licensees Agreement State Radiation Control
Implementing the Increased Program Directors and State Liaison
Control Order Officers.
06/05/07 RIS-07-15 NRC Regulatory Issue Summary All NRC licensees that are non-
2007-15 Unescorted Access to manufacturer and distributor (non-M&D)
Materials for Non-Manufacturer service providers. All Agreement State
and Distributor Service Providers Radiation Control Program Directors and
State Liaison Officers.
10/04/07 RIS-07-22 Status Update for Implementation All NRC materials licensees, radiation
of NRC Regulatory Authority for control program directors, State liaison
Certain naturally-Occurring and officers, and the NRCs Advisory
Accelerator-Produced Radioactive Committee on the Medical Uses of
Material Isotopes.
10/04/07 RIS-07-23 Date for Operation of National All licensees authorized to possess
Source Tracking System 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.