[Federal Register Volume 71, Number 24 (Monday, February 6, 2006)]
[Notices]
[Pages 6100-6101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1568]
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NUCLEAR REGULATORY COMMISSION
[EA-05-136]
In the Matter of Digirad Imaging Solutions, Inc.; Confirmatory
Order (Effective Immediately)
Digirad Imaging Solutions, Incorporated (DIGIRAD or Licensee) is
the holder of Byproduct Material License 31-30666-01 issued by the
Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR
Parts 30 and 35. This mobile medical license authorizes possession of
radionuclides for medical diagnosis, including uptake, dilution and
excretion studies permitted by 10 CFR 35.100; and imaging and
localization studies permitted by 10 CFR 35.200. The license further
authorizes possession and use of byproduct material at specified
facilities located in Indiana, Michigan, Missouri, New Jersey,
Pennsylvania, Virginia, and West Virginia. The license also authorizes
use of byproduct material at temporary jobsites of the licensee
anywhere in the United States where the NRC maintains jurisdiction for
regulating the use of licensed material, including areas of exclusive
Federal jurisdiction within Agreement States. The license was
originally issued on August 21, 2001, was due to expire on July 31,
2005, and is currently under timely renewal pursuant to 10 CFR
30.36(a)(1).
On August 6, 2004, the NRC Office of Investigations (OI) initiated
an investigation (OI Case No. 1-2004-034) to determine if a physician
listed on the DIGIRAD NRC license submitted false information to
DIGIRAD in October 2003 to become an Authorized User (AU) on its
existing NRC license. Based on the evidence developed during its
investigations, OI substantiated that false and/or inaccurate
information was submitted to DIGIRAD by the physician for the purpose
of adding that physician as an AU on the existing DIGIRAD NRC license.
The results of the investigation completed on June 15, 2005, were sent
to DIGIRAD in a letter dated September 15, 2005. This letter stated
that a physician listed as an AU on DIGIRAD's NRC license deliberately
provided inaccurate information to DIGIRAD to become an AU on DIGIRAD's
license, but that DIGIRAD did not knowingly submit the false
information to the NRC in an amendment request dated October 16, 2003,
that it submitted to the NRC to add the physician to the list of AUs on
the license.
Subsequent to becoming aware of the NRC investigation and of the
apparent violation, DIGIRAD took several actions to assure that these
events would not recur. These actions included: (a) Immediately
removing two AUs from its license; (b) cancelling a contract it had
with one of the physicians; (c) attaching to physicians and preceptors
statement form a notice equivalent to the following: ``Notice to
Physician and Preceptor: 10 CFR 30.9(a) and 30.10(a) require that all
information provided to the Nuclear Regulatory Commission by a licensee
or its agents shall be complete and accurate in all material respects.
The submission of false information constitutes a serious violation of
applicable regulations and may cause you or us to be fined, to lose
licensing privileges, or to suffer other significant penalties.''; and
(d) requiring any physician that is added to its license to sign and
date a document containing a statement equivalent to the following:
``In connection with my application to be named as an Authorized User
on Digirad Imaging Solution's (``DIS'') radioactive materials license,
I am aware that the submission of information that is not complete and
accurate in all material respects is a violation of 10 CFR Sections
30.9(a) and 30.10(a). I hereby represent and warrant that, to the best
of my knowledge, the information I have submitted to DIS in connection
with my application to be named as an Authorized User is complete and
accurate in all material respects.''
Also, in response to the NRC's September 15, 2005, letter, DIGIRAD
requested the use of Alternative Dispute Resolution (ADR) to resolve
this apparent violation and pending enforcement action. ADR is a
process in which a neutral mediator, with no decision-making authority,
assists the NRC and DIGIRAD to resolve any disagreements on whether a
violation occurred, the appropriate enforcement action, and the
appropriate corrective actions. An ADR session was held between DIGIRAD
and the NRC in King of Prussia, PA, on November 14, 2005, and was
mediated by a professional mediator, arranged through Cornell
University's Institute of Conflict Management. Based on discussions at
the ADR mediation session, as well as subsequent discussions held on
December 14 and 15, 2005, between Vera Pardee, Vice President and
General Counsel for DIGIRAD, and Karl Farrar, Region I Counsel, a
settlement agreement was reached. The elements of the settlement
agreement consisted of the following:
1. The NRC and DIGIRAD agreed to disagree on the violation being in
careless disregard of NRC requirements.
2. DIGIRAD took the corrective actions described in Section II
above prior to attending the ADR Mediation Session on November 14,
2005.
3. As a means to provide added assurance to meet the requirements
of 10 CFR 30.9(a) and 30.10(a), DIGIRAD agreed that for all future NRC
AU applicants, on a yearly basis, it will audit the training and
experience credentials of the first 10 AU applicants and 25% of any
applications received after the first 10. DIGIRAD will audit by
endeavoring to locate and call preceptors as well as Continuing Medical
Education providers to verify the information given by the AU
applicants. This does not eliminate the requirement that DIGIRAD
provide complete and accurate information to the NRC on all AU
applicants. The
[[Page 6101]]
results of this audit will be documented and submitted to the NRC at
the end of a two-year period. However, DIGIRAD will notify the NRC as
soon as practicable after identification of any discrepancies
identified as a result of the audit. If no falsifications are uncovered
during the two-year period, DIGIRAD will discontinue the practice.
4. In addition, DIGIRAD will take other actions to ensure that
similar violations will not recur. These actions will include the Vice
President and Corporate Radiation Safety Officer preparing and
submitting a commentary to (a) the Journal of Nuclear Medicine, (b) the
Journal of Nuclear Medicine Technology, and (c) the Journal of Medical
Physics to provide an opportunity for other licensees in the industry
to learn from this incident. DIGIRAD will advise NRC upon completion of
these items and not later than one year from the date of this
agreement.
5. In light of the corrective actions that DIGIRAD has taken or has
committed to take as described in Items 2, 3 and 4, the NRC agreed to
issue a Severity Level III Notice of Violation to DIGIRAD (10 CFR
30.9(a)), but to not issue a Civil Penalty. This action will be
publicly available in ADAMS and on the NRC ``Significant Enforcement
Actions'' Web site, and the NRC will issue a press release announcing
this action, as well as the actions DIGIRAD has taken and committed to
take to address the violation.
6. DIGIRAD agreed to issuance of a Confirmatory Order confirming
this agreement.
In light of the actions DIGIRAD has taken and agreed to take to
correct the violation and prevent recurrence, as set forth in section
III above, the NRC has concluded that its concerns regarding the
violation can be resolved through the NRC's confirmation of the
commitments as outlined in this Confirmatory Order.
I find that DIGIRAD's commitments as set forth in section III above
are acceptable. However, in view of the foregoing, I have determined
that these commitments shall be confirmed by this Confirmatory Order.
Based on the above and DIGIRAD's consent, this Confirmatory Order is
immediately effective upon issuance.
Accordingly, pursuant to Sections 103, 161b, 161i, 161o, 182, and
186 of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202 and 10 CFR part 30 and 35, it is hereby
ordered, that by August 23, 2006:
1. DIGIRAD will audit, for all future NRC AU applicants, on a
yearly basis, the training and experience credentials of the first 10
AU applicants and 25% of any applications received after the first 10.
DIGIRAD will audit by endeavoring to locate and call preceptors as well
as Continuing Medical Education providers to verify the information
given by the AU applicants. This does not eliminate the requirement
that DIGIRAD provide complete and accurate information to the NRC on
all AU applicants. The results of this audit will be documented and
submitted to the NRC at the end of a two-year period. However, DIGIRAD
will notify the NRC as soon as practicable after identification of any
discrepancies identified as a result of the audit. If no falsifications
are uncovered during the two-year period, DIGIRAD will discontinue the
practice.
2. The DIGIRAD Vice President and Corporate Radiation Safety
Officer will prepare and submit a commentary regarding this violation
to the Journals of Nuclear Medicine, Nuclear Medicine Technology, and
Medical Physics to provide an opportunity for other licensees in the
industry to learn from this incident.
3. DIGIRAD will advise NRC upon completion of these items and not
later than one year from the date of this agreement.
The Director, Office of Enforcement, may relax or rescind, in
writing, any of the above conditions upon a showing by DIGIRAD of good
cause.
Any person adversely affected by this Confirmatory Order, other
than DIGIRAD, may request a hearing within 20 days of its issuance.
Where good cause is shown, consideration will be given to extending the
time to request a hearing. A request for extension of time must be made
in writing to the Director, Office of Enforcement, U.S. Nuclear
Regulatory Commission, Washington, DC 20555, and must include a
statement of good cause for the extension. Any request for a hearing
shall be submitted to the Secretary, U.S. Nuclear Regulatory
Commission, ATTN: Chief, Rulemaking and Adjudications Staff,
Washington, DC 20555. Copies of the hearing request shall also be sent
to the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, to the Assistant General Counsel for
Materials Litigation and Enforcement, to the Director of the Division
of Regulatory Improvement Programs at the same address, and to MSHMC.
Because of continuing disruptions in delivery of mail to United States
Government offices, it is requested that answers and requests for
hearing be transmitted to the Secretary of the Commission either by
means of facsimile transmission to 301-415-1101 or by e-mail to
[email protected] and also to the Office of the General Counsel by
means of facsimile transmission to 301-415-3725 or e-mail to
[email protected]. If such a person requests a hearing, that person
shall set forth with particularity the manner in which his interest is
adversely affected by this Order and shall address the criteria set
forth in 10 CFR 2.714(d).
If a hearing is requested by a person whose interest is adversely
affected, the Commission will issue an Order designating the time and
place of any hearing. If a hearing is held, the issue to be considered
at such hearing shall be whether this Confirmatory Order shall be
sustained. An answer or a request for a hearing shall not stay the
effectiveness date of this order.
Dated this 27th day of January 2006.
For the Nuclear Regulatory Commission.
Michael Johnson,
Office of Enforcement.
[FR Doc. E6-1568 Filed 2-3-06; 8:45 am]
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