Bradley D. Bastow, D. O., South Haven, Michigan; Confirmatory Order Modifying License, 56745-56749 [2013-22315]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56745-56749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22315]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-35710; License No. 21-32316-01; EA-13-025; NRC-2013-
0208]


Bradley D. Bastow, D. O., South Haven, Michigan; Confirmatory 
Order Modifying License

I

    Bradley D. Bastow, D. O., (Dr. Bastow or the licensee) is the 
holder of Materials License No. 21-32316-01 issued by the U.S. Nuclear 
Regulatory Commission (NRC) pursuant to part 30 of Title 10 of the Code 
of Federal Regulations (10 CFR) on April 20, 2001, and renewed on 
December 7, 2011. The license authorizes the operation of Bradley D. 
Bastow, D. O., at his place of business (Cardiology II, P.C.) 
(facility) in accordance with conditions specified therein. The 
facility is located on the licensee's site in South Haven, Michigan.
    This Confirmatory Order is the result of an agreement reached 
during an alternative dispute resolution (ADR) mediation session 
conducted on July 1, 2013.

II

    On February 28, and April 3, 2012, the NRC conducted a special 
inspection at the Bradley D. Bastow, D. O., facility in South Haven, 
Michigan, with continued in-office review through May 24, 2012. The 
details of the inspection were documented in NRC Inspection Report No. 
03035710/2012001(DNMS) issued on December 19, 2012. During the 
inspection, several unresolved items were identified that required 
further NRC review. The NRC Office of Investigations (OI) began an 
investigation on April 2, 2012 into several of the issues. OI completed 
its investigation on January 31, 2013.
    During the inspection and investigation, the NRC determined that 
Bradley D. Bastow, D. O., was in apparent violation of NRC requirements 
by: (1) Failing to perform weekly contamination surveys; (2) failing to 
perform storage area surveys; (3) failing to conduct a survey 
instrument calibration; (4) failing to monitor the external surfaces of 
labeled packages for radioactive contamination; (5) failing to conduct 
dose calibrator linearity tests that were calibrated with nationally 
recognized standards; (6) failing to conduct a formal annual review of 
the radiation safety program; (7) failing to ensure that records were 
complete and accurate; (8) failing to issue a whole body radiation 
exposure measuring device to an individual who was occupationally 
exposed to ionizing photon radiation on a regular basis and failing to 
issue a finger radiation exposure measuring device to an individual who 
handled radioactive material on a regular basis; (9) failing to read 
film badges on a monthly basis, and the named Radiation Safety Officer 
(RSO) failing to evaluate the results; (10) failing to leak test sealed 
sources at 6-month intervals; (11) failing to conduct a semi-annual 
physical inventory of all sealed sources in its possession; (12) 
failing to perform daily surveys; (13) failing to assay wipes for 
removable contamination using a procedure sufficiently sensitive to 
detect 2000 disintegrations per minute (dpm); and (14) the named RSO 
failing to ensure that radiation safety activities were being performed 
in accordance with licensee-approved procedures and regulatory 
requirements.
    On July 1, 2013, Bradley D. Bastow, D. O., and the NRC met in an 
ADR session mediated by a professional mediator, arranged through 
Cornell University's Institute on Conflict Resolution. ADR is a process 
in which a neutral mediator with no decision-making authority assists 
the parties in reaching an agreement on resolving any differences 
regarding the dispute. This confirmatory order is issued pursuant to 
the agreement reached during the ADR process.

III

    In response to the NRC's offer, Bradley D. Bastow, D. O., requested 
use

[[Page 56746]]

of the NRC ADR process to resolve differences it had with the NRC. 
During that ADR session, a preliminary settlement agreement was 
reached. The elements of the agreement consisted of the following:

A. Restoring Compliance

    A.1. The NRC will issue a written Notice of Violation to accompany 
the Order addressing the violations and the licensee will respond with 
how the violations were corrected, within 30 days of the date of the 
Order. The NRC agrees to group the violations to reduce the total 
number such that all the completeness and accuracy violations are 
discussed in one violation and all the survey violations are discussed 
in a second violation.
    A.2. Within 30 days of the date of the Order, the licensee will 
ensure that all equipment listed on the license (except the well 
counter) is restored to service, calibrated, and operable, including a 
back-up survey meter. In the case of the well counter, the licensee 
will either restore a well counter to service (calibrated and operable) 
or will provide a license amendment request for alternate 
instrumentation within 60 days of the date of the Order.

B. RSO Responsibilities and Involvement

    B.1. Within 90 days of the date of the Order, Dr. Bastow will 
complete a medical RSO refresher training class (approximately 8 
hours).
    B.2. Within 60 days of completion of the RSO training identified in 
B.1, Dr. Bastow will meet with and ``shadow'' for at least 8 hours 
another RSO who oversees a nuclear medical program. The licensee will 
retain documentation showing the name of the RSO whom he shadowed, 
contact information, approximate hours spent and insights gained. If 
Dr. Bastow is unable to shadow another RSO, then the licensee will 
document the names and contact information for three individuals whom 
he contacted, the dates of contact and the reasons they provided for 
not allowing him to shadow them.
    B.3. Upon issuance of the Order, the licensee will increase 
radiation safety program reviews from annually to quarterly for one 
year and provide a copy of the reports to the NRC within 60 days of 
completion of the audits. The reports must include all documented 
safety concerns raised by persons (staff and contractors) performing 
duties under the NRC license, along with any self-identified violations 
and the corrective actions taken to resolve the concerns. After the 
first year, the licensee will provide its annual written report to the 
NRC for the next three years. The reviews will be conducted by an 
independent consultant under contract with the licensee. The licensee 
must provide written certification that he has reviewed the report and 
agrees with the results of the review along with independent 
observations that he has made of the health of the radiation safety 
program; the licensee will also implement actions recommended in the 
report or document justification for not implementing the recommended 
actions.

C. Safety Culture

    C.1. Within 30 days of the date of the Order, the licensee will 
document a written Safety Culture Policy that applies to all persons 
(staff and contractors) performing duties under the NRC license. The 
policy must include that concerns will be documented, the actions taken 
to resolve the concerns, who resolved the concern, and when the 
concerned was resolved. Upon resolution of the concern, the documented 
concern is signed by both the concerned individual and the RSO that 
resolution was satisfactory. If the concern cannot be resolved, the 
documented concern should state why the concern cannot be resolved and 
the concerned individual understands why the concern cannot be 
resolved. The Safety Culture Policy must iterate that any concerned 
individual can contact the NRC (provide phone number and contact person 
at NRC) for additional action on nuclear safety issues if necessary. 
The licensee shall provide a copy of the policy to all persons (staff 
and contractors) performing duties under the NRC license and 
conspicuously post the policy or a notice about the policy in the 
licensee's office in several locations.
    C.2. Within 60 days of the date of the Order, the RSO will provide 
initial training to the staff and contractors performing duties under 
the NRC license regarding safety culture and raising safety concerns. 
For the next two years, the RSO will provide annual refresher training. 
The RSO will provide training to any new staff or contractors 
performing duties under the NRC license within 30 days of their 
arrival. Documentation of the training will be maintained for future 
inspection, including the dates of the training, the names of the 
attendees, and the subjects covered.
    C.3. Once a quarter beginning within 60 days of the date of the 
Order, the licensee will meet with each person (staff and contractors) 
performing duties under the NRC license to solicit concerns and will 
document any concerns and the actions taken to address them. This shall 
continue for at least three years. The results shall be documented in 
the quarterly or annual audit.

D. Accuracy and Completeness of Records

    D.1. Within 90 days of the date of the Order, the licensee will 
review its records for 2012 and 2013 against NRC requirements and 
license commitments. The licensee will verify that all required records 
(including all records and documents created in support of such 
records) are onsite and are available for inspection. Furthermore, the 
licensee shall ensure that any supporting worksheets are clearly 
attached. The licensee shall ensure all documentation is complete, 
accurate, clear, and legible and information is easily traceable from 
one form to another without question. For example, survey 
instrumentation shall clearly indicate model and serial numbers. If 
forms or documents contain signature blocks, the name of the signee 
will be printed or typed on the form and will include a date signed. 
This review shall be completed within 90 days of the date of the Order. 
Any discrepancies will be documented and the NRC informed within the 
following 30 days.
    D.2. The NRC agrees to waive any additional enforcement action for 
any additional examples of the violations described above identified as 
a result of the reconciliation effort identified in D.1.

E. Notification of Completion of Activities

    Unless otherwise specified, the licensee will submit written 
notification to: U.S. NRC Region III, Director, Division of Nuclear 
Material Safety, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-
4352.
    Upon completion of each specific action at six months, one year, 
and annually thereafter until total completion.
    F. The resulting Confirmatory Order will be considered an escalated 
enforcement action by the NRC for any future assessment of Bradley D. 
Bastow, D. O., as appropriate.
    G. In consideration of the commitments above, the NRC agrees to a 
civil penalty in the amount of $1,000 and to take no further 
enforcement action in the matter of EA-13-025 discussed in the NRC's 
letter to Dr. Bastow dated April 18, 2013.
    On August 22, 2013, Bradley D. Bastow, D. O., consented to issuing 
this Order with the commitments, as described in Section V below. 
Bradley D. Bastow, D. O., further agreed that this

[[Page 56747]]

Order is to be effective upon issuance and that the licensee has waived 
its right to a hearing.

IV

    Since the licensee has agreed to take additional actions to address 
NRC concerns, as set forth in Item III above, the NRC has concluded 
that its concerns can be resolved through issuance of this Confirmatory 
Order.
    I find that Bradley D. Bastow, D. O.'s commitments as set forth in 
Section V are acceptable and necessary and conclude that with these 
commitments the public health and safety are reasonably assured. In 
view of the foregoing, I have determined that public health and safety 
require that Bradley D. Bastow, D. O.'s commitments be confirmed by 
this Order. Based on the above and Bradley D. Bastow, D. O.'s consent, 
this Confirmatory Order is effective upon issuance.

V

    Accordingly, pursuant to Sections 81,161b, 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, it is hereby ordered, 
that license no. 21-32316-01 is modified as follows:

A. Restoring Compliance

    A.1. Within 30 days of the date of the Order, the licensee will 
respond with how the violations enclosed with the Order were corrected.
    A.2. Within 30 days of the date of the Order, the licensee will 
ensure that all equipment listed on the license (except the well 
counter) is restored to service, calibrated, and operable, including a 
back-up survey meter. In the case of the well counter, the licensee 
will either restore a well counter to service (calibrated and operable) 
or will provide a license amendment request for alternate 
instrumentation within 60 days of the date of the Order.

B. RSO Responsibilities and Involvement

    B.1 Within 90 days of the date of the Order, Dr. Bastow will 
complete a medical RSO refresher training class (approximately 8 
hours).
    B.2. Within 60 days of completion of the RSO training identified in 
B.1, Dr. Bastow will meet with and ``shadow'' for at least 8 hours 
another RSO who oversees a nuclear medical program. The licensee will 
retain documentation showing the name of the RSO whom he shadowed, 
contact information, approximate hours spent and insights gained. If 
Dr. Bastow is unable to shadow another RSO, then the licensee will 
document the names and contact information for three individuals whom 
he contacted, the dates of contact, and the reasons they provided for 
not allowing him to shadow them.
    B.3. Upon issuance of the Order, the licensee will increase 
radiation safety program reviews from annually to quarterly for one 
year, and provide a copy of the reports to the NRC within 60 days of 
completion of the reviews. The reports must include all documented 
safety concerns raised by persons (staff and contractors) performing 
duties under the NRC license, along with any self-identified violations 
and the corrective actions taken to resolve the concerns. After the 
first year, the licensee will provide its annual written report to the 
NRC for the next three years. The reviews will be conducted by an 
independent consultant under contract with the licensee. The licensee 
must provide written certification that he has reviewed the report and 
agrees with the results of the review along with independent 
observations that he has made of the health of the radiation safety 
program; the licensee will also implement actions recommended in the 
report or document justification for not implementing the recommended 
actions.

C. Safety Culture

    C.1. Within 30 days of the date of the Order, the licensee will 
document a written Safety Culture Policy that applies to all persons 
(staff and contractors) performing duties under the NRC license. The 
policy must include that all concerns will be documented, the actions 
to be taken by the licensee to resolve the concerns, which individual 
will be responsible for the resolution of the concerns, and the 
expected timeframe in which the concern will be resolved. Upon 
resolution of the concern, the documented concern is signed by both the 
concerned individual and the RSO that resolution was satisfactory. If 
the concern cannot be resolved, the documented concern should state why 
the concern cannot be resolved and that the concerned individual 
understands why the concern cannot be resolved. The Safety Culture 
Policy must iterate that any concerned individual can contact the NRC 
(provide phone number and contact person at NRC) for additional action 
on nuclear safety issues if necessary. The licensee shall provide a 
copy of the policy to all persons (staff and contractors) performing 
duties under the NRC license and conspicuously post the policy or a 
notice about the policy in the licensee's office in at least two 
locations.
    C.2. Within 60 days of the date of the Order, the RSO will provide 
initial training to the staff and contractors performing duties under 
the NRC license regarding safety culture and raising safety concerns. 
For the next two years, the RSO will provide annual refresher training. 
The RSO will provide training to any new staff or contractors 
performing duties under the NRC license within 30 days of their 
arrival. Documentation of the training will be maintained for future 
inspection, including the dates of the training, the names of the 
attendees, and the subjects covered.
    C.3. Once a quarter beginning within 60 days of the date of the 
Order, the licensee will meet with each person (staff and contractors) 
performing duties under the NRC license to solicit concerns and will 
document any concerns and the actions taken to address them. This shall 
continue for at least three years. The results shall be documented in 
the quarterly or annual audit.

D. Accuracy and Completeness of Records

    D.1 Within 90 days of the date of the Order, the licensee will 
review its records for 2012 and 2013 against NRC requirements and 
license commitments. The licensee will verify that all required records 
(including all records and documents created in support of such 
records) are onsite and are available for inspection. Furthermore, the 
licensee shall ensure that any supporting worksheets are clearly 
attached. This review shall be completed within 90 days of the date of 
the Order. Any discrepancies will be documented and the NRC informed 
within the following 30 days.
    The licensee shall ensure all documentation completed following 
issuance of the Order is complete, accurate, clear, and legible. For 
example, survey instrumentation shall clearly indicate model and serial 
numbers. If forms or documents contain signature blocks, the name of 
the signee will be printed or typed on the form and will include a date 
signed.

E. Notification of Completion of Activities

    Unless otherwise specified, the licensee will submit written 
notification to: U.S. NRC Region III, Director, Division of Nuclear 
Material Safety, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-
4352.
    Upon completion of each specific action at six months, one year, 
and

[[Page 56748]]

annually thereafter until total completion.
    F. Within 30 days of the date of the Order, the licensee shall pay 
the civil penalty in the amount of $1,000 in accordance with NUREG/BR-
0254 and submit to the Director, Office of Enforcement, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555, a statement indicating 
when and by what method payment was made.
    The Regional Administrator, Region Ill, may, in writing, relax or 
rescind any of the above conditions upon demonstration by Bradley D. 
Bastow, D. O., of good cause.

VI

    Any person adversely affected by this Confirmatory Order, other 
than Bradley D. Bastow, D. O., may request a hearing within 20 days of 
its publication in the Federal Register. 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 include a statement of good cause for the 
extension.
    All documents filed in NRC adjudicatory proceedings, including a 
request for hearing, a petition for leave to intervene, any motion or 
other document filed in the proceeding prior to the submission of a 
request for hearing or petition to intervene, and documents filed by 
interested governmental entities participating under 10 CFR 2.315(c), 
must be filed in accordance with the NRC E-Filing rule (72 FR 49139, 
August 28, 2007). The E-Filing process requires participants to submit 
and serve all adjudicatory documents over the internet, or in some 
cases to mail copies on electronic storage media. Participants may not 
submit paper copies of their filings unless they seek an exemption in 
accordance with the procedures described below.
    To comply with the procedural requirements of E-Filing, at least 
ten (10) days prior to the filing deadline, the participant should 
contact the Office of the Secretary by email at hearing.docket@nrc.gov, 
or by telephone at 301-415-1677, to request: (1) A digital ID 
certificate, which allows the participant (or its counsel or 
representative) to digitally sign documents and access the E-Submittal 
server for any proceeding in which it is participating; and (2) advise 
the Secretary that the participant will be submitting a request or 
petition for hearing (even in instances in which the participant, or 
its counsel or representative, already holds an NRC-issued digital ID 
certificate). Based upon this information, the Secretary will establish 
an electronic docket for the hearing in this proceeding if the 
Secretary has not already established an electronic docket.
    Information about applying for a digital ID certificate is 
available on NRC's public Web site at https://www.nrc.gov/site-help/e-submittals/apply-certificates.html. System requirements for accessing 
the E-Submittal server are detailed in NRC's ``Guidance for Electronic 
Submission,'' which is available on the agency's public Web site at 
https://www.nrc.gov/site-help/e-submittals.html. Participants may 
attempt to use other software not listed on the Web site, but should 
note that the NRC's E-Filing system does not support unlisted software, 
and the NRC Meta System Help Desk will not be able to offer assistance 
in using unlisted software.
    If a participant is electronically submitting a document to the NRC 
in accordance with the E-Filing rule, the participant must file the 
document using the NRC's online, Web-based submission form. In order to 
serve documents through the Electronic Information Exchange (EIE), 
users will be required to install a Web browser plug-in from the NRC 
Web site. Further information on the Web-based submission form, 
including the installation of the Web browser plug-in, is available on 
the NRC's public Web site at https://www.nrc.gov/site-help/e-submittals.html.
    Once a participant has obtained a digital ID certificate and a 
docket has been created, the participant can then submit a request for 
hearing or petition for leave to intervene. Submissions should be in 
Portable Document Format (PDF) in accordance with NRC guidance 
available on the NRC public Web site at https://www.nrc.gov/site-help/e-submittals.html. A filing is considered complete at the time the 
documents are submitted through the NRC's E-Filing system. To be 
timely, an electronic filing must be submitted to the E-Filing system 
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of 
a transmission, the E-Filing system time-stamps the document and sends 
the submitter an email notice confirming receipt of the document. The 
E-Filing system also distributes an email notice that provides access 
to the document to the NRC Office of the General Counsel and any others 
who have advised the Office of the Secretary that they wish to 
participate in the proceeding, so that the filer need not serve the 
documents on those participants separately. Therefore, applicants and 
other participants (or their counsel or representative) must apply for 
and receive a digital ID certificate before a hearing request/petition 
to intervene is filed so that they can obtain access to the document 
via the E-Filing system.
    A person filing electronically using the agency's adjudicatory E-
Filing system may seek assistance by contacting the NRC Meta System 
Help Desk through the ``Contact Us'' link located on the NRC Web site 
at https://www.nrc.gov/site-help/e-submittals.html, by email at 
MSHD.Resource@nrc.gov, or by a toll-free call at 866-672-7640. The NRC 
Meta System Help Desk is available between 8 a.m. and 8 p.m., Eastern 
Time, Monday through Friday, excluding government holidays.
    Participants who believe that they have a good cause for not 
submitting documents electronically must file an exemption request, in 
accordance with 10 CFR 2.302(g), with their initial paper filing 
requesting authorization to continue to submit documents in paper 
format. Such filings must be submitted by: (1) First class mail 
addressed to the Office of the Secretary of the Commission, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemaking and Adjudications Staff; or (2) courier, express mail, or 
expedited delivery service to the Office of the Secretary, Sixteenth 
Floor, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland, 20852, Attention: Rulemaking and Adjudications Staff. 
Participants filing a document in this manner are responsible for 
serving the document on all other participants. Filing is considered 
complete by first-class mail as of the time of deposit in the mail, or 
by courier, express mail, or expedited delivery service upon depositing 
the document with the provider of the service. A presiding officer, 
having granted an exemption request from using E-Filing, may require a 
participant or party to use E-Filing if the presiding officer 
subsequently determines that the reason for granting the exemption from 
use of E-Filing no longer exists.
    Documents submitted in adjudicatory proceedings will appear in 
NRC's electronic hearing docket which is available to the public at 
https://ehd1.nrc.gov/ehd/, unless excluded pursuant to an order of the 
Commission, or the presiding officer. Participants are requested not to 
include personal privacy information, such as social security numbers, 
home addresses, or home phone numbers in their filings,

[[Page 56749]]

unless an NRC regulation or other law requires submission of such 
information. With respect to copyrighted works, except for limited 
excerpts that serve the purpose of the adjudicatory filings and would 
constitute a Fair Use application, participants are requested not to 
include copyrighted materials in their submission.
    If a person other than the licensee requests a hearing, that person 
shall set forth with particularity the manner in which his interest is 
adversely affected by this Confirmatory Order and shall address the 
criteria set forth in 10 CFR 2.309(d) and (f).
    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 should be 
sustained.
    In the absence of any request for hearing, or written approval of 
an extension of time in which to request a hearing, the provisions 
specified in Section V above shall be final 20 days from the date this 
Confirmatory Order is published in the Federal Register without further 
order or proceedings. If an extension of time for requesting a hearing 
has been approved, the provisions specified in Section V shall be final 
when the extension expires if a hearing request has not been received.
    A request for hearing shall not stay the effectiveness of this 
order.

    Dated this 3rd day of September 2013.

    For the Nuclear Regulatory Commission.
Cynthia D. Pederson,
Regional Administrator, Region III.
[FR Doc. 2013-22315 Filed 9-12-13; 8:45 am]
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