Information Notice 2012-08, High Dose-Rate Remote Afterloader (Hdr) Physical Presence Requirements
ML11320A228 | |
Person / Time | |
---|---|
Issue date: | 04/10/2012 |
From: | Brian Mcdermott NRC/FSME/DMSSA |
To: | |
Rivera-Cappella, Gretchen 415-5944 | |
References | |
IN-12-008 | |
Download: ML11320A228 (7) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555 April 10, 2012 NRC INFORMATION NOTICE 2012-08: HIGH DOSE-RATE REMOTE AFTERLOADER (HDR)
PHYSICAL PRESENCE REQUIREMENTS
ADDRESSEES
All U.S. Nuclear Regulatory Commission (NRC) high dose-rate remote afterloader (HDR)
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 remind addressees of the HDR physical
presence requirements described in 10 CFR 35.615(f)(2). No specific action or written
response is required. It is expected that recipients will review the information for applicability to
their facilities and consider actions, as appropriate, to avoid similar issues. The NRC is
providing this IN to the Agreement States for their information and for distribution to their HDR
licensees as appropriate.
DESCRIPTION OF CIRCUMSTANCES
During inspections of HDR facilities, the NRC staff has identified several issues associated with
implementation of the physical presence requirement in 10 CFR 35.615(f)(2). The following is a
brief overview of NRC staff findings:
Case #1 During an inspection in 2008, NRC inspectors noted that the licensees procedures allowed an
authorized user (AU) to designate and train a non-AU physician to fulfill the physical presence
requirement during the initiation and continuation of HDR treatments.
Case #2 During an inspection in 2008 to follow-up on a reported medical event, NRC inspectors noted
that an AU was not within normal hearing distance of the HDR console and was not able to
assist the authorized medical physicist (AMP) in responding to a device error message. The
AMPs erroneous response to the error message resulted in a medical event. In this event, the
AU was not afforded the opportunity to review the error message or the AMPs response to the
error message, which resulted in a change from the intended treatment position.
ML11320A228 Case #3 During an inspection in 2009, NRC inspectors observed that the only person physically present
at the console during an HDR patient treatment was the AMP, who also served as the Radiation
Safety Officer (RSO). The AMP/RSO stated that the AU had been present for initiation of the
treatment, but then had to leave for a meeting outside of the department. The AU stated they
were typically physically present for the initiation but not during continuation of HDR treatments.
The AU usually remained within the Radiation Oncology Department, seeing other patients or
working in their office, but did not remain within hearing distance of normal voice of the HDR
control console.
Case #4 During an inspection in 2010, NRC inspectors observed a patient undergoing an HDR treatment
and noted when the treatment was initiated the AMP was not present at the console, but a
dosimetrist and the AU were present. The AMP was in another area of the Radiation Oncology
Department, not within hearing distance of normal voice of the HDR control console, at the
initiation of the patient treatment.
Case #5 During an inspection in 2010, NRC inspectors noted that an AU and AMP were present for the
initiation and continuation of patient treatment as required by 10 CFR 35.615(f)(2). However, when reviewing the licensees procedures for HDR treatments, the inspectors noted that the
procedures did not appear to meet the physical presence requirements contained in the
regulations. Specifically, the inspectors noted that the licensees procedures allowed for either
an AU or AMP to be physically present. The licensee indicated that the procedures had been
developed in accordance with the manufacturers instructions.
Case #6 During an inspection in 2011, NRC inspectors identified that after initiation of an HDR treatment, the AU routinely left the console area to conduct various tasks or to sometimes see patients in
other rooms within the Radiation Oncology Department. Typically, the door to the console area
was closed to maintain patient privacy. During HDR treatments, the AU periodically checked
the treatment progress, and met with the patient at the conclusion of the treatment. The
licensee also described that the AU could be summoned by the intercom to return to the
treatment area if needed.
DISCUSSION
After analyzing these incidents, the NRC staff has recognized three types of errors associated
with licensee interpretation of the physical presence requirement for HDR treatments. The
errors are described in detail below and include: (1) the AU or AMP was not physically present
in the HDR console area during initiation or continuation of a patient treatment; (2) the AU or
AMP relied on alternate personnel to meet the physical presence requirements; and (3) the
licensees procedures allowed either the AU or AMP to leave the console area. The regulations in 10 CFR 35.615(f)(2) state that the licensee shall, for [HDR] units, require an
[AU] and an [AMP] to be physically present during the initiation of all patient treatments involving
the unit; and an [AMP] and either an [AU] or a physician, under the supervision of an [AU], who
has been trained in the operation and emergency response for the unit, to be physically present
during continuation of all patient treatments involving the unit. The meaning of physically
present as used in the regulations was defined in the April 24, 2002 Federal Register Notice,Section V, Summary of Changes, (67 FR 20355) as within hearing distance of normal voice.
The word normal as used within the context of normal hearing distance should be given its
dictionary meaning of regular, average, or not deviating from an established rule.
Based on the definition for normal voice, the NRC has determined that the need for a raised
voice in order for the AU and AMP to communicate with each other does not fit the definition of
normal as used within the context of normal hearing distance. Therefore, the location of the
HDR console (for instance, around a corner or behind a door), or high background noise due to
loud equipment, will affect what the normal hearing distance is. Licensees should take into
consideration the specific environment in which the HDR unit is operating, remaining mindful
that communication between the AU and AMP must be such that the use of a raised voice is not
necessary. Furthermore, the NRC has determined for other therapy devices that the use of
communication devices, such as walkie talkies, intercoms, or any device used to transmit or
amplify the human voice, does not meet the description of normal hearing distance [see
Regulatory Issue Summary (RIS) 2005-023], and therefore, their use is not allowed as a means
of fulfilling the physical presence requirement in 10 CFR 35.615.
The NRC found that in some cases, licensees misinterpreted the physical presence
requirements in 10 CFR 35.615 as being met if the AU and AMP were present only during
initiation of the treatment. In other cases, licensees believed that either the AU or AMP could be
present for initiation of the treatment only. And finally, many licensees believed that as long as
the individual not present was able to be rapidly summoned via a raised voice or intercom, that
physical presence was met. In the cases described, the NRC found that licensees either were
not aware of the details of the regulations or were not taking into account their specific operating
conditions when determining what constituted physical presence within hearing distance of
normal voice. Licensee procedures should include consideration of their specific operating
conditions to ensure that both an AU and AMP are physically present within normal hearing
distance of the HDR treatment console during initiation of the patient treatment and that an
AMP and either the AU or a non-AU physician who meets the requirements in 10 CFR
35.615(f)(2)(ii) are physically present within normal hearing distance of the HDR treatment
console during continuation of the patient treatment. In addition, licensees who have adopted
manufacturers guidance should review their procedures to ensure that the regulatory
requirements are correctly stated.
The NRC also notes that the regulations do not define initiation of treatment or specifically
describe whether this statement refers to only the first fraction of a treatment course (e.g.,
during fraction one of five) or to only the first fraction to be delivered on that day, and not to
initiation of each treatment fraction. However, to verify that the correct dose is being delivered, it is important to emphasize that the AU and AMP must be physically present during the
initiation of each treatment fraction. Therefore, initiation of treatment should be considered as
the initiation of each treatment fraction and not solely the initiation of the course of treatment. The NRC also believes that the inherent risk of the HDR procedures justifies the need for a
properly trained AU (or AU-supervised physician for continuation) and AMP to be available at all
times to verify dose, monitor device operations, and respond to an emergency situation.
Therefore, the regulations do not allow for the presence of any other personnel (e.g.,
dosimetrist) to meet the physical presence requirements of an AMP under any circumstances
(initiation or continuation); an AMP must always be physically present during initiation and
continuation of HDR treatments. Also, in addition to the AMP, although 10 CFR 35.615(f)(2)(ii)
allows a non-AU physician under the supervision of an AU to fulfill the physical presence
requirements during the continuation of an HDR treatment, 10 CFR 35.615(f)(2)(i) allows only
an AU to fulfill the physical presence requirements during the initiation of an HDR treatment.
This ensures appropriate personnel are available to verify that the correct dose is being
delivered to the patient (i.e., AU and AMP) and to respond to an emergency (i.e., AMP and
physician trained to respond to emergencies).
For additional information, licensees can find frequently asked questions regarding the physical
presence requirement during HDR treatments on the NRCs Medical Uses Licensee Toolkit
Web site, at: http://www.nrc.gov/materials/miau/med-use-toolkit/faqs-part35.html.
RELATED GENERIC COMMUNICATION
RIS 2005-23, Clarification of the Physical Presence Requirement During Gamma Stereotactic
Radiosurgery Treatments.
CONTACT
This IN requires no specific action or written response. If you have any questions about the
information in this notice, please contact one of the technical contacts listed below or the
appropriate regional office.
/Pam Henderson for/RA/
Brian J. McDermott, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Programs
Technical Contact:
Penny Lanzisera, RI
(610) 337-5169 E-mail: Penny.Lanzisera@nrc.gov
Enclosure:
List of Recently Issued FSME Generic
Communications The NRC also believes that the inherent risk of the HDR procedures justifies the need for a properly
trained AU (or AU-supervised physician for continuation) and AMP to be available at all times to verify
dose, monitor device operations, and respond to an emergency situation. Therefore, the regulations do
not allow for the presence of any other personnel (e.g., dosimetrist) to meet the physical presence
requirements of an AMP under any circumstances (initiation or continuation); an AMP must always be
physically present during initiation and continuation of HDR treatments. Also, in addition to the AMP,
although 10 CFR 35.615(f)(2)(ii) allows a non-AU physician under the supervision of an AU to fulfill the
physical presence requirements during the continuation of an HDR treatment, 10 CFR 35.615(f)(2)(i)
allows only an AU to fulfill the physical presence requirements during the initiation of an HDR treatment.
This ensures appropriate personnel are available to verify that the correct dose is being delivered to the
patient (i.e., AU and AMP) and to respond to an emergency (i.e., AMP and physician trained to respond
to emergencies).
For additional information, licensees can find frequently asked questions regarding the physical presence
requirement during HDR treatments on the NRCs Medical Uses Licensee Toolkit Web site, at:
http://www.nrc.gov/materials/miau/med-use-toolkit/faqs-part35.html.
CONTACT
This IN requires no specific action or written response. If you have any questions about the information in
this notice, please contact one of the technical contacts listed below or the appropriate regional office.
/Pam Henderson for/RA/
Brian J. McDermott, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Programs
Technical Contact:
Penny Lanzisera, RI
(610) 337-5169 E-mail: Penny.Lanzisera@nrc.gov
Enclosure:
List of Recently Issued FSME Generic
Communications
ML11320A228 OFC RI/DNMS RI/DNMS FSME/RMSB FSME/RMSB
NAME PLanzisera *MFerdas MFuller AMcIntosh
DATE 10/18/11 10/18/11 10/20/11 10/18/11 OFC FSME/RMSB OGC FSME/MSSA FSME/MSSA
NAME CEinberg BJones PHenderson BMcDermott
DATE 10/23/11 11/3/11 4/10/12 4/1012 OFFICIAL RECORD COPY
Enclosure
IN 2012-08 Page 1of 2 List of Recently Issued Office of Federal and State Material
and Environmental Management Programs Generic Communications
Date GC No. Subject
Addressees
03/20/2012 RIS-2012-04 Notice of Revision to the Criteria for All U.S. Nuclear Regulatory Commission
Identifying Materials Licensees for materials licensees (including fuel cycle
Discussion at the Agency Action facilities and master material licensees),
Review Meeting Agreement State Radiation Control
Program Directors, and State Liaison
Officers.
01/17/2012 RIS-2012-01 Availability of Safety Culture Policy All U.S. Nuclear Regulatory Commission
Statement licensees, certificate holders, permit
holders, authorization holders, holders of
quality assurance program approvals, vendors and suppliers of safety-related
components, and applicants subject to
NRC authority. All Agreement State
Radiation Control Program Directors, State
Liaison Officers, and other interested
stakeholders.
12/14/2011 RIS-2006-20, Guidance for Receiving All community water systems in the U.S.
Rev. 1 Enforcement Discretion When Nuclear Regulatory Commission non- Concentrating Uranium at Agreement States that, while treating
Community Water Systems drinking water, may accumulate and
concentrate naturally-occurring uranium in
media, effluents, and other residuals, above 0.05 percent by weight. All
Agreement State and Non-Agreement
State Radiation Control Program Directors
and State Liaison Officers
09/29/2011 RIS-2011-11 Regarding Long-Term Surveillance All holders of operating licenses for
Charge for Conventional or Heap conventional or heap leach uranium
Leach Uranium Recovery Facilities recovery facilities; holders of licenses for
Licensed Under 10 CFR Part 40 conventional or heap leach uranium
recovery facilities in decommissioning;
companies that have submitted
applications to construct new conventional
or heap leach uranium recovery facilities or
letters of intent to submit such applications;
UMTRCA
Title II sites; Agreement State Radiation
Control Program Directors, and State
Liaison Officers
08/31/2011 RIS-2011-10 Informing Licensees About the All U.S. Nuclear Regulatory Commission
NRCs Public Web Site for licensees, certificate holders, permit
Significant Enforcement Actions holders, applicants, Agreement State
When Evaluating Individuals for Radiation Control Program Directors, State
Employment Liaison Officers, and other interested
stakeholders.
Enclosure
IN 2012-08 Page 1of 2 List of Recently Issued Office of Federal and State Material
and Environmental Management Programs Generic Communications
Date GC No. Subject
Addressees
08/16/2011 RIS-2011-09 Available Resources Associated All U.S. Nuclear Regulatory Commission
with Extended Storage of Low-Level licensees, certificate holders, permit
Radioactive Waste holders, authorization holders, holders of
quality assurance program approvals, vendors and suppliers of safety-related
components, and applicants subject to
NRC authority. All Agreement State
Radiation Control Program Directors, State
Liaison Officers, and other interested
stakeholders.
Note: This list contains the six most recently issued generic communications, issued by the Office of Federal and
State Materials and Environmental Management Programs (FSME). A full listing of all generic communications
may be viewed at the NRC public website at the following address: http://www.nrc.gov/reading-rm/doc- collections/gen-comm/index.html