[Federal Register Volume 87, Number 247 (Tuesday, December 27, 2022)]
[Notices]
[Pages 79364-79372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28136]
-----------------------------------------------------------------------
NUCLEAR REGULATORY COMMISSION
[EA-22-003; NRC-2022-0196]
In the Matter of Cabell Huntington Hospital
AGENCY: Nuclear Regulatory Commission.
ACTION: Confirmatory order; issuance.
-----------------------------------------------------------------------
SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
Confirmatory Order to Cabell Huntington Hospital (CHH) to memorialize
the agreement reached during an alternative dispute resolution
mediation session held on August 24, 2022. The Confirmatory Order
contains commitments made to resolve 14 apparent violations of NRC
requirements related to the development and implementation of CHH's
radiation protection program, CHH's compliance with occupational dose
limits, and CHH's possession of licensed material at an unauthorized
location. These violations were identified during NRC inspections and
an investigation conducted by the NRC Office of Investigations. The
Confirmatory Order is effective upon issuance.
DATES: The Confirmatory Order was issued on November 10, 2022.
ADDRESSES: Please refer to Docket ID NRC-2022-0196 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly available information related to this document
using any of the following methods:
Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0196. Address
questions about Docket IDs in Regulations.gov to Stacy Schumann;
telephone: 301-415-0624; email: [email protected]. For technical
questions, contact the individual listed in the ``For Further
Information Contact'' section of this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Document collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, contact the NRC's Public Document
Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email
to [email protected]. The ADAMS accession number for each document
referenced (if it is available in ADAMS) is provided the first time
that it is mentioned in this document.
NRC's PDR: You may examine and purchase copies of public
documents, by appointment, at the NRC's PDR, Room P1 B35, One White
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make
an appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between
8:00 a.m. and 4:00 p.m. Eastern Time (ET), Monday through Friday,
except Federal holidays
FOR FURTHER INFORMATION CONTACT: Cherie Crisden, Region I, U.S. Nuclear
Regulatory Commission, 475 Allendale Road, Suite 102, King of Prussia,
PA 19406; telephone: 610-337-5061, email: [email protected].
SUPPLEMENTARY INFORMATION: The text of the Order is attached.
Dated: December 21, 2022.
For the Nuclear Regulatory Commission.
Raymond K. Lorson,
Regional Administrator, NRC Region I.
[[Page 79365]]
[GRAPHIC] [TIFF OMITTED] TN27DE22.036
[[Page 79366]]
[GRAPHIC] [TIFF OMITTED] TN27DE22.037
United States of America
Nuclear Regulatory Commission
In the Matter of: CABELL HUNTINGTON HOSPITAL
Docket No. 03003370
License No. 47-00404-02
EA-22-003
Confirmatory Order Modifying License (Effective Upon Issuance)
I
Cabell Huntington Hospital (CHH) is the holder of byproduct
materials License No. 47-00404-02 issued by the U.S. Nuclear Regulatory
Commission (NRC or Commission) pursuant to Part 35 of Title 10 of the
Code of Federal Regulations (10 CFR), ``Medical Use of Byproduct
Material.'' The license authorizes the use of byproduct materials by
CHH, in accordance with conditions specified therein. CHH has multiple
medical facilities in West
[[Page 79367]]
Virginia and is authorized to possess and use byproduct material for
diagnostic and therapeutic medical uses.
This Confirmatory Order is the result of an agreement reached
during an Alternative Dispute Resolution (ADR) mediation session
conducted on August 24, 2022.
II
On June 22, 2022, the NRC issued Inspection Report No. 03003370/
2021001 to CHH. The report documented the results of a routine
inspection in May 2021, that reviewed the activities performed under
the NRC license held by CHH to ensure that activities were performed in
accordance with NRC requirements and with the conditions of the
license. The inspection report also documented the results of
additional NRC inspection activities associated with a CHH report to
the NRC on October 23, 2021, concerning an overexposure to an
authorized user (AU) of Yttrium-90 (Y-90), and an incident on November
8, 2021, involving the receipt of licensed material at an unauthorized
location.
In addition to the inspection, on June 21, 2021, the NRC's Office
of Investigations (OI) opened an investigation (OI Case No. 1-2021-015)
to determine whether interventional radiologists (IRs) who were
authorized users of Y-90 at CHH deliberately failed to wear their
supplied dosimetry when administering Y-90 and whether the Radiation
Safety Officer (RSO) deliberately failed to require interventional
radiologists to wear their dosimetry during Y-90 procedures.
Based on the results of the inspection and investigation, the NRC
identified 14 apparent violations, of which 11 were considered for
escalated enforcement action. One of the apparent violations being
considered for escalated enforcement was determined to be willful. This
violation involved CHH's failure to monitor occupational exposure to
radiation from licensed and unlicensed radiation sources under the
control of the licensee, as required by 10 CFR 20.1502(a)(1), and the
apparent willful failure to wear dosimetry by an authorized user of Y-
90. Although the violation was determined to be willful, it did not
adversely impact patient safety. The other 10 violations considered for
escalated enforcement involved CHH's failure to: (1) Develop, document,
and implement a radiation protection program commensurate with the
scope and extent of licensed activities and sufficient to ensure
compliance with the provisions of 10 CFR part 20; (2) provide the RSO
with sufficient management prerogative to identify radiation safety
problems and stop unsafe operations; (3) instruct individuals who are
likely to receive in a year an occupational dose in excess of 100 mrem
in the applicable provisions of NRC regulations and requirements in its
license for the protection of personnel from exposure to radiation and/
or radioactive material; (4) reduce the dose that an individual may be
allowed to receive in the current year by the amount of occupational
dose received while employed by any other person; (5) control the
occupational dose to the skin or to any extremity of individual adults
to an annual dose limit of 50 rem shallow-dose equivalent; (6) control
the occupational dose to individual adults to an annual dose limit of 5
rem total effective dose equivalent; (7) control the occupational dose
to the lens of the eye of individual adults to an annual dose limit of
15 rem dose equivalent; (8) confine possession and use of byproduct
materials to the locations and purposes authorized by its license; (9)
control and maintain constant surveillance of licensed material that is
in a controlled or unrestricted area and that is not in storage; and
(10) comply with the applicable requirements of the Department of
Transportation regulations appropriate to the mode of transport. By
letter dated June 22, 2022, the NRC notified CHH of the results of the
inspection and OI investigation and offered CHH the opportunity to (1)
attend a predecisional enforcement conference or (2) participate in an
ADR mediation session, in an effort to resolve these concerns.
In response to the NRC's letter, CHH requested the use of the NRC's
ADR process. On August 24, 2022, the NRC and CHH met in an ADR session
mediated by a professional mediator, arranged through Cornell
University's Institute on Conflict Resolution. The ADR process is one
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
During the ADR mediation session, CHH and the NRC reached a
preliminary settlement agreement. The elements of that agreement are
set forth below:
Whereas the NRC acknowledges that CHH has taken several corrective
actions in response to the violations so as to preclude the occurrence
of similar violations in the future. These corrective actions were
documented in Inspection Report 03003370/2021001 dated June 22, 2022.
In addition to actions described in the report, CHH created and filled
a full-time Assistant Radiation Safety Officer position to assist in
the implementation of its Radiation Protection Program, in addition to
other actions that were described at the ADR session conducted on
August 24, 2022.
Select corrective actions [already completed and described during
the ADR session] are described below:
1. CHH developed a centralized radiation safety policy titled
``Mountain Health Network Comprehensive Radiation Safety Policy'' that
applies to all CHH facilities. The policy includes instructions on the
use of dosimetry, compliance requirements with the licensee's
occupational monitoring program, and additional detail on indicators of
improper dosimeter use. CHH has also instituted an ALARA [as low as
reasonably achievable] review process for unused or unusually low
dosimetry results.
2. CHH developed and assigned an electronic training module to the
[lR AUs] that provides instruction on the proper use of dosimetry.
3. One [AU] that had exceeded occupational dose limits in calendar
year (CY) 2021 was not permitted to work with licensed material for the
remainder of CY 2021.
4. CHH provided in-person instruction to supply chain and security
staff instructing them to not transport radioactive material to or from
CHH facilities.
5. CHH has created an electronic learning module that will be
assigned to all staff and will communicate that radioactive material is
not to be transported to or from CHH facilities by staff.
6. CHH revised its policy titled ``Ordering and Receiving
Radioactive Material'' to include additional communication information
and cautions. Additionally, the policy has been revised to include a
system for ordering lr-192 sources.
7. CHH revised its policy titled ``Safely Opening Radioactive
Material Packages'' to include [receipt of] lr-192 sources.
8. CHH created a policy regarding the shipping and receiving of lr-
192 sources.
9. CHH restructured its Radiation Safety Committee such that it is
now a single committee with oversight of all authorized locations of
use.
Therefore, the parties agree to the following terms and conditions:
[[Page 79368]]
I. Terms and Conditions to be taken by CHH
A. Development of a Resource Plan
1. CHH shall review the Radiation Protection Program oversight
functions of the RSO and develop a resource plan to ensure compliance
with NRC requirements. CHH shall review the appliable guidance in
NUREG-1556, ``Consolidated Guidance About Materials Licenses,'' to
determine the activities required to be performed by the RSO and to
evaluate the resources needed to ensure those activities are adequately
completed.
Within 30 days of the effective date of the confirmatory order, CHH
shall inform the NRC that the action is complete by sending a letter to
the Region I Administrator, along with a copy of the resource plan. The
resource plan shall include the individuals' names, qualifications, and
time commitment. The reporting structure of the qualified individuals
must be documented in the resource plan. The resource plan shall be
maintained and made available for NRC inspection for a period of three
years after the date of submission of the resource plan to the NRC.
Beginning one year after the date of submission of the resource
plan to the NRC, CHH shall review annually and document planned versus
actual resources expended by December 31, 2023, and December 31, 2024.
The results of these reviews shall be made available for NRC inspection
for a period of three years after the date of submission of the
resource plan to the NRC.
B. Radiation Safety Committee Charter Development and Implementation
1. CHH shall develop and, after receipt of NRC approval, implement
a Radiation Safety Committee (RSC) charter. The charter shall include
clearly defined RSC's membership with documented roles and
responsibilities for each member, including deliverables and
accountability expectations. The charter shall also identify a CHH
senior manager to serve as the chairman of the RSC, a reporting
structure of the RSC, and applicable training requirements for all RSC
members on the roles and responsibilities of their positions within the
RSC.
Within 180 days of the effective date of the confirmatory order,
CHH shall inform the NRC that CHH has developed an RSC charter by
sending a letter to the Region I Administrator and submitting the RSC
charter and associated member training materials for NRC review and
approval (prior to initial implementation). CHH will notify the NRC in
writing of any changes to the RSC charter for a period of up to three
years from the date of the receipt of NRC approval of the RSC charter.
2. CHH shall maintain copies of RSC member training materials for a
period of 3 years after a training has been conducted for review during
NRC inspection. Records of training participation shall include the
individual's name, title, and date of training; these records shall
also be maintained by CHH and made available during NRC inspection for
3 years after the associated training has been conducted.
C. Third Party Audit
1. Within 360 days of the effective date of the confirmatory order,
CHH shall have one or more independent third-party national consulting
firms complete [an audit] of CHH's radiation protection program. The
audit shall focus on identifying issues and providing recommendations
to the licensee. The audit shall include, at a minimum, the following
elements:
a. The authority and oversight of the consultant RSO and the
adequacy of the RSO contract.
b. The process and procedures for ordering and receiving various
types of radioactive material, including the different methods for
purchasing and receiving radioactive material, and how communication
impacts this process.
c. The occupational monitoring program, to include an assessment of
the adequacy of procedures, dosimetry selection, and program
implementation.
d. CHH's nuclear safety culture relative to the NRC's safety
culture policy statement (https://www.nrc.gov/about-nrc/safety-culture/sc-policy-statement.html) or equivalent. Specifically, the audit shall
identify organizational opportunities to improve nuclear safety
culture. This would include training for applicable radiation safety
staff and the need for workshops for CHH leadership, as appropriate.
2. CHH shall submit the name and qualifications of the third-party
consultant(s) for NRC approval within 90 days of the effective date of
the confirmatory order.
3. Within 45 days of completing the third-party audit pursuant to
Section I.C.1, CHH shall inform the NRC that the third-party audit is
complete by sending a letter to the Region I Administrator. CHH shall
maintain and make the results of the audit, including any non-
compliances identified, recommendations, and any corrective actions
taken or not taken (and why such action was not taken) as a result of
the audit, and a copy of the planned actions available for review
during NRC inspection for a period of 3 years from the date of NRC
notification pursuant to Section I.C.3.
D. Program Assessment
1. Within 180 days of the effective date of the confirmatory order,
CHH shall complete a review of the radiation protection program.
Specifically, CHH shall analyze, as part of this review, what actions
would be needed for it to shift to performance-based oversight of
radiation protection, with clear expectations for continuous
improvement. The review shall address, at a minimum, whether the
following actions would be warranted to implement a performance-based
approach: unannounced area audits, process audits, walk downs by
management, 1:1 meetings when new managers become responsible for
elements of the radiation protection program, processes for determining
how to handle areas of non-compliance, and ALARA investigations of
abnormal dosimetry results. At a minimum, the radiation protection
program shall include documentation of the responsible individual(s),
assessment objectives, minimum criteria to consider an assessment
complete, frequency of each assessment, action to be taken when
findings occur, management and RSC notification of assessment findings.
2. Within 90 days of completing the review pursuant to Section
I.D.1, CHH shall inform the NRC that the action is complete by sending
a letter to the Region I Administrator, with a written copy of CHH's
radiation protection policies and procedures, specifying any revisions
made in response to the review conducted pursuant to Section I.D.1. Any
policies, findings, and related documentation shall be maintained and
made available for NRC inspection for a period 3 years following
completion of this action.
E. Training Program
Within 270 days of the effective date of the confirmatory order,
CHH shall complete a review of its current radiation protection
training program and revise it consistent with the guidance provided in
NUREG-1556. Specifically, the review shall assess the sufficiency of
training, shall be informed by the results of any periodic assessments
of the radiation protection program, and shall establish record-keeping
requirements.
1. Within 30 days of completing the review, CHH shall inform the
NRC of the completion of the review by sending a letter to the Region I
Administrator
[[Page 79369]]
documenting any planned changes to its training program. The letter
shall include a description of the standards used to inform the scope
and conduct of the review. CHH shall maintain and make its radiation
protection training program, along with associated radiation protection
training materials, available to the NRC for inspection for a period of
three years after notification to the NRC of the completion of the
review.
F. External Communication
1. Within 720 days of the effective date of the confirmatory order,
CHH shall have conducted the following communications of the importance
of ALARA practices with applicable industry clinicians/physician
related organizations. Specifically:
a. CHH shall have attempted at least three times to provide a
presentation to a national organization that has a membership comprised
of physician authorized users of byproduct material. The presentation
shall include a description of the reported exposure received by an AU
at CHH including the practice used (i.e., hand in the beam), magnitude
of exposure, lessons learned, the importance of adherence to NRC
requirements for occupational monitoring, and related corrective
actions undertaken by CHH. Within 30 days of completing the
presentation, CHH shall inform the NRC that the action is complete by
sending a letter to the Region I Administrator and shall make the
presentation materials available to the NRC for three years after the
presentation for review during NRC inspection. Presentation materials
shall consist of a slide show, at a minimum. If the presentation has
not been accepted after three submission attempts by CHH to different
national organizations, then CHH shall notify the NRC by sending a
letter to the Region I Administrator, including with the letter the
rejected presentation proposals, as well as intended presentation
materials.
b. CHH shall have attempted at least three times to publish a paper
in a journal that has a readership comprised of physician authorized
users of byproduct material. The paper shall include a description of
the reported exposure received by an AU at CHH including the practice
used (i.e., hand in the beam), magnitude of exposure, lessons learned,
the importance of adherence to NRC requirements for occupational
monitoring, and related corrective actions undertaken by CHH. Within 30
days of submitting the paper, CHH shall inform the NRC that the action
is complete by sending a letter to the Region I Administrator and shall
make the paper available to the NRC for three years after the paper is
submitted for review during NRC inspection. If the paper has not been
accepted for publication after three submission attempts have been made
by CHH to different journals, then CHH shall notify the NRC by sending
a letter to the Region I Administrator, all with copies of all versions
of the paper tendered for publication.
2. As specified below, CHH shall discuss the issues it encountered
related to the maintenance of its radiation protection program:
a. Within 720 days of the effective date of the confirmatory order,
CHH shall have attempted at least three times to provide a presentation
describing the issues related to the maintenance of its radiation
protection program, resolution of the issues, and the path to
compliance to a national organization that has a membership comprised
of health physics and radiation professionals. Within 30 days of
completing this presentation, CHH shall inform the NRC that the action
is complete by sending a letter to the Region I Administrator and shall
make the presentation materials available to the NRC for three years
after the presentation for review during NRC inspection. Presentation
materials shall consist of a slide show, at a minimum. If the
presentation has not been accepted after three submission attempts by
CHH to different national organizations, then CHH shall notify the NRC
by sending a letter to the Region I Administrator, including with the
letter the rejected presentation proposals, as well as intended
presentation materials.
b. Within 720 days of the effective date of the confirmatory order,
CHH shall have attempted at least three times to have a paper published
by a national journal that has a readership comprised of health physics
and radiation professionals related to the issues related to the
maintenance of its radiation protection program, resolution of the
issues, and the path to compliance. Within 30 days of a paper
submission attempt, CHH shall inform the NRC that the action is
complete by sending a letter to the Region I Administrator and shall
make the paper available to the NRC for three years after the paper is
submitted for review during NRC inspection. If the paper has not been
accepted for publication after three submission attempts have been made
by CHH to different journals, then CHH shall notify the NRC by sending
a letter to the Region I Administrator, along with copies of all
versions of the paper tendered for publication.
II. Terms and Conditions To Be Taken by NRC
1. The NRC agrees not to issue a civil penalty and does not intend
to take further action for the violations described in inspection
report 03003370/2021001.
2. The NRC agrees to not issue a separate Notice of Violation in
addition to the confirmatory order but, rather, to describe the
violations in the body of the confirmatory order instead. The
description will include that one of the violations involved the
deliberate actions of a non-employee authorized user for failure to
wear required occupational dose monitoring devices and that this
violation did not impact patient care.
3. For the NRC's future civil penalty assessment purposes as
discussed in the NRC Enforcement Policy, the NRC agrees that the
issuance of this Confirmatory Order will be considered as escalated
enforcement.
4. The NRC will issue a press release to coincide with the issuance
of the confirmatory order.
5. In the event of the transfer of the license of Cabell Huntington
Hospital to another entity, the terms and conditions set forth
hereunder shall continue to apply to the Cabell Huntington Hospital and
accordingly survive any transfer of ownership or license.
On November 7, 2022, CHH consented to issuing this Confirmatory
Order with the commitments, as described in Section V below. CHH
further agrees that this Confirmatory Order is to be effective upon
issuance, the agreement memorialized in this Confirmatory Order settles
the matter between the parties, and that CHH has waived its right to a
hearing.
IV
Because CHH has agreed to take additional actions to address NRC
concerns, as set forth in Section III above, the NRC has concluded that
its concerns can be resolved through issuance of this Confirmatory
Order.
The NRC finds that CHH's actions completed, as described in Section
III above, combined with the commitments as set forth in Section V, are
acceptable and necessary; the NRC concludes that with these commitments
in place the public health and safety will be reasonably assured. In
view of the foregoing, the NRC has determined that public health and
safety require that CHH's commitments be confirmed by this Confirmatory
Order. Based on the above and CHH's consent, this
[[Page 79370]]
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,
Effective Upon Issuance, That License No. 47-00404-02 Is Modified as
Follows:
A. Development of a Resource Plan
1. CHH shall review the Radiation Protection Program oversight
functions of the RSO and develop a resource plan to ensure compliance
with NRC requirements. CHH shall review the appliable guidance in
NUREG-1556 to determine the activities required to be performed by the
RSO and to evaluate the resources needed to ensure those activities are
adequately completed.
Within 30 days of the effective date of the Confirmatory Order, CHH
shall inform the NRC that the action is complete by sending a letter to
the Region I Administrator, along with a copy of the resource plan. The
resource plan shall include the individuals' names, qualifications, and
time commitment. The reporting structure of the qualified individuals
must be documented in the resource plan. The resource plan shall be
maintained and made available for NRC inspection for a period of three
years after the date of submission of the resource plan to the NRC.
Beginning one year after the date of submission of the resource
plan to the NRC, CHH shall review planned versus actual resources
expended during calendar year 2023 and document the findings of the
review by December 31, 2023. CHH shall perform a similar review for
calendar year 2024 and document the findings by December 31, 2024. The
results of these reviews shall be made available for NRC inspection for
a period of three years after the date of submission of the resource
plan to the NRC.
B. Radiation Safety Committee (RSC) Charter Development and
Implementation
1. CHH shall develop and, after receipt of NRC approval (as
described below), implement an RSC charter. The charter shall include
clearly defined RSC's membership with documented roles and
responsibilities for each member, including deliverables and
accountability expectations. The charter shall also identify a CHH
senior manager to serve as the chairman of the RSC, a reporting
structure of the RSC, and applicable training requirements for all RSC
members on the roles and responsibilities of their positions within the
RSC.
Within 180 days of the effective date of the Confirmatory Order,
CHH shall inform the NRC that CHH has developed an RSC charter by
sending a letter to the Region I Administrator and submitting the RSC
charter and associated member training materials for NRC review and
approval (prior to initial implementation). CHH will notify the NRC in
writing of any changes to the RSC charter for a period of up to three
years from the date of the receipt of NRC approval of the RSC charter.
2. CHH shall maintain copies of RSC member training materials for a
period of 3 years after a training has been conducted for review during
NRC inspection. Records of training participation shall include the
individual's name, title, and date of training; these records shall
also be maintained by CHH and made available during NRC inspection for
3 years after the associated training has been conducted.
C. Third Party Audit
1. Within 360 days of the effective date of the Confirmatory Order,
CHH shall engage at least one independent third-party national
consulting firm to complete an audit of CHH's radiation protection
program. The audit shall focus on identifying issues and providing
recommendations to the licensee. The audit shall include, at a minimum,
the following elements:
a. The authority and oversight of the consultant RSO and the
adequacy of the RSO contract.
b. The process and procedures for ordering and receiving various
types of radioactive material, including the different methods for
purchasing and receiving radioactive material, and how communication
impacts this process.
c. The occupational monitoring program, to include an assessment of
the adequacy of procedures, dosimetry selection, and program
implementation.
d. CHH's nuclear safety culture relative to the NRC's safety
culture policy statements https://www.nrc.gov/about-nrc/safety-culture/sc-policy-statement.html or equivalent. Specifically, the audit shall
identify organizational opportunities to improve nuclear safety
culture. This would include training for applicable radiation safety
staff and the need for workshops for CHH leadership, as appropriate.
2. CHH shall submit the name and qualifications of the third-party
consultant(s) for NRC approval within 90 days of the effective date of
the Confirmatory Order.
3. Within 45 days of completing the third-party audit pursuant to
Section V.C.1, CHH shall inform the NRC that the third-party audit is
complete by sending a letter to the Region I Administrator. CHH shall
maintain and make the results of the audit, including any findings
identified, recommendations, and any corrective actions taken or not
taken (and why such action was not taken) as a result of the audit, and
a copy of the planned actions, available for review during NRC
inspection for a period of 3 years from the date of NRC notification
pursuant to Section V.C.3.
D. Program Assessment
1. Within 180 days of the effective date of the Confirmatory Order,
CHH shall complete an assessment of its radiation protection program.
Specifically, CHH shall analyze, as part of this assessment, what
actions would be needed for it to shift to performance-based oversight
of radiation protection, with clear expectations for continuous
improvement. The assessment shall address, at a minimum, whether the
following actions would be warranted to implement a performance-based
approach: unannounced area audits, process audits, walk downs by
management, one-on-one meetings when new managers become responsible
for elements of the radiation protection program, processes for
determining how to handle areas of non-compliance, and ALARA
investigations of abnormal dosimetry results. At a minimum, the
radiation protection program policies and procedures for conducting
periodic evaluations shall be updated and shall include documentation
of the responsible individual(s), evaluation objectives, minimum
criteria to consider an evaluation complete, frequency of each
evaluation, action to be taken when findings occur, and management and
RSC notification of evaluation findings.
2. Within 90 days of completing the assessment pursuant to Section
V.D.1, CHH shall inform the NRC that the action is complete by sending
a letter to the Region I Administrator, with a written copy of CHH's
radiation protection policies and procedures, specifying any revisions
made in response to the assessment conducted pursuant to Section V.D.1.
Any policies, findings, and related documentation shall be maintained
and made available for NRC inspection for a period 3 years following
completion of this action.
[[Page 79371]]
E. Training Program
1. Within 270 days of the effective date of the Confirmatory Order,
CHH shall complete a review of its current radiation protection
training program and revise it consistent with the guidance provided in
NUREG-1556. Specifically, the review shall assess the sufficiency of
training, shall be informed by the results of any periodic assessments
of the radiation protection program, and shall establish record-keeping
requirements.
2. Within 30 days of completing the review pursuant to Section
V.E.1, CHH shall inform the NRC of the completion of the review by
sending a letter to the Region I Administrator documenting any planned
changes to its training program. The letter shall include a description
of the standards used to inform the scope and conduct of the review.
CHH shall maintain and make its radiation protection training program,
along with associated radiation protection training materials,
available to the NRC for inspection for a period of three years after
notification to the NRC of the completion of the review.
F. External Communication
1. Within 720 days of the effective date of the Confirmatory Order,
CHH shall have conducted the following communications of the importance
of ALARA practices with applicable industry clinicians/physician
related organizations:
a. CHH shall have attempted at least three times to provide a
presentation to a national organization that has a membership comprised
of physician authorized users of byproduct material. The presentation
shall include a description of the reported exposure received by an AU
at CHH including the practice used (i.e., hand in the beam), magnitude
of exposure, lessons learned, the importance of adherence to NRC
requirements for occupational monitoring, and related corrective
actions undertaken by CHH. Within 30 days of completing the
presentation, CHH shall inform the NRC that the action is complete by
sending a letter to the Region I Administrator and shall make the
presentation materials available to the NRC for review during NRC
inspections for three years after the presentation. Presentation
materials shall consist of a slide show, at a minimum. If the
presentation has not been accepted after three submission attempts by
CHH to different national organizations, then CHH shall notify the NRC
by sending a letter to the Region I Administrator, including with the
letter the rejected presentation proposals, as well as intended
presentation materials.
b. CHH shall have attempted at least three times to publish a paper
in a journal that has a readership comprised of physician authorized
users of byproduct material. The paper shall include a description of
the reported exposure received by an AU at CHH including the practice
used (i.e., hand in the beam), magnitude of exposure, lessons learned,
the importance of adherence to NRC requirements for occupational
monitoring, and related corrective actions undertaken by CHH.
Within 30 days of a paper submission attempt, CHH shall inform the
NRC that the action is complete by sending a letter to the Region I
Administrator and shall make the paper available to the NRC for review
during NRC inspections for three years after the paper is submitted to
the journal for review. If the paper has not been accepted for
publication after three submission attempts have been made by CHH to
different journals, then CHH shall notify the NRC by sending a letter
to the Region I Administrator, all with copies of all versions of the
paper tendered for publication.
2. As specified below, CHH shall discuss the issues it encountered
related to the maintenance of its radiation protection program.
a. Within 720 days of the effective date of the Confirmatory Order,
CHH shall have attempted at least three times to provide a presentation
describing the issues related to the maintenance of its radiation
protection program, resolution of the issues, and the path to
compliance to a national organization that has a membership comprised
of health physics and radiation professionals. Within 30 days of
completing this presentation, CHH shall inform the NRC that the action
is complete by sending a letter to the Region I Administrator and shall
make the presentation materials available to the NRC for three years
after the presentation for review during NRC inspection. Presentation
materials shall consist of a slide show, at a minimum. If the
presentation has not been accepted after three submission attempts by
CHH to different national organizations, then CHH shall notify the NRC
by sending a letter to the Region I Administrator, including with the
letter the rejected presentation proposals, as well as intended
presentation materials.
b. Within 720 days of the effective date of the Confirmatory Order,
CHH shall have attempted at least three times to have a paper published
by a national journal that has a readership comprised of health physics
and radiation professionals related to the issues related to the
maintenance of its radiation protection program, resolution of the
issues, and the path to compliance. Within 30 days of a paper
submission attempt, CHH shall inform the NRC that the action is
complete by sending a letter to the Region I Administrator and shall
make the paper available to the NRC during NRC inspections for three
years after the paper is submitted to the journal for review. If the
paper has not been accepted for publication after three submission
attempts have been made by CHH to different journals, then CHH shall
notify the NRC by sending a letter to the Region I Administrator, along
with copies of all versions of the paper tendered for publication.
This agreement is binding upon successors and assignees of CHH. The
Regional Administrator, Region I, may relax or rescind, in writing, any
of the above conditions upon demonstration by CHH or its successors of
good cause.
VI
In accordance with 10 CFR 2.202 and 10 CFR 2.309, any person
adversely affected by this Confirmatory Order, other than CHH, may
request a hearing within thirty (30) calendar days of the date of
issuance of this Confirmatory Order. 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
documents filed by an interested State, local governmental body,
Federally recognized Indian Tribe, or designated agency thereof that
requests to participate under 10 CFR 2.315(c), must be filed in
accordance with 10 CFR 2.302. 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,
unless an exemption permitting an alternative filing method, as further
discussed, is granted. Detailed guidance on electronic submissions is
located in the ``Guidance for Electronic Submissions to the NRC''
(ADAMS Accession No. ML13031A056) and on the NRC's public website at
https://www.nrc.gov/site-help/e-submittals.html.
To comply with the procedural requirements of E-Filing, at least 10
[[Page 79372]]
days prior to the filing deadline, the participant should contact the
Office of the Secretary by email at [email protected], or by
telephone at 301-415-1677, to (1) request a digital identification (ID)
certificate, which allows the participant (or its counsel or
representative) to digitally sign submissions and access the E-Filing
system for any proceeding in which it is participating; and (2) advise
the Secretary that the participant will be submitting a petition or
other adjudicatory document (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 proceeding if the
Secretary has not already established an electronic docket.
Information about applying for a digital ID certificate is
available on the NRC's public website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. After a digital ID certificate is
obtained and a docket created, the participant must submit adjudicatory
documents in Portable Document Format. Guidance on submissions is
available on the NRC's public website at https://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the
time the document is 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. ET on the due date. Upon receipt of a
transmission, the E-Filing system time-stamps the document and sends
the submitter an email confirming receipt of the document. The E-Filing
system also distributes an email that provides access to the document
to the NRC's 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 document on those
participants separately. Therefore, applicants and other participants
(or their counsel or representative) must apply for and receive a
digital ID certificate before adjudicatory documents are filed to
obtain access to the documents via the E-Filing system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic
Filing Help Desk through the ``Contact Us'' link located on the NRC's
public website at https://www.nrc.gov/site-help/e-submittals.html, by
email to [email protected], or by a toll-free call at 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9:00
a.m. and 6:00 p.m., ET, Monday through Friday, except Federal holidays.
Participants who believe that they have 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
stating why there is good cause for not filing electronically and
requesting authorization to continue to submit documents in paper
format. Such filings must be submitted in accordance with 10 CFR
2.302(b)-(d). Participants filing adjudicatory documents in this manner
are responsible for serving their documents on all other participants.
Participants granted an exemption under 10 CFR 2.302(g)(2) must still
meet the electronic formatting requirement in 10 CFR 2.302(g)(1),
unless the participant also seeks and is granted an exemption from 10
CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in the
NRC's electronic hearing docket, which is publicly available at https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the
presiding officer. If you do not have an NRC-issued digital ID
certificate as previously described, click ``cancel'' when the link
requests certificates and you will be automatically directed to the
NRC's electronic hearing dockets where you will be able to access any
publicly available documents in a particular hearing docket.
Participants are requested not to include personal privacy information
such as social security numbers, home addresses, or personal phone
numbers in their filings 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
should not include copyrighted materials in their submission.
If a person other than CHH requests a hearing, that person shall
set forth with particularity the manner in which their 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 hearings. 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 30 days from the date of
this Confirmatory Order 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.
For the Nuclear Regulatory Commission
Raymond K. Lorson,
Deputy Regional Administrator, NRC Region I.
Dated this 10th day of November 2022
[FR Doc. 2022-28136 Filed 12-23-22; 8:45 am]
BILLING CODE 7590-01-P