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Received: 9 May 2022 Revised: 9 August 2022 Accepted: 22 September 2022

DOI: 10.1002/acm2.13829

AAPM REPORTS & DOCUMENTS

AAPM medical physics practice guideline 13.a: HDR


brachytherapy, part A

Susan L. Richardson1 Ivan M. Buzurovic2 Gil’ad N. Cohen3


Wesley S. Culberson4 Claire Dempsey5 Bruce Libby6
Christopher S. Melhus7 Robin A. Miller8 Daniel J. Scanderbeg9
Samantha J. Simiele10

1
Swedish Medical Center, Seattle, Abstract
Washington, USA
The American Association of Physicists in Medicine (AAPM) is a nonprofit
2
Brigham & Women’s Hospital, Harvard professional society whose primary purposes are to advance the science, edu-
Medical School, Boston, MA, USA
cation, and professional practice of medical physics. The AAPM has more than
3
Memorial Sloan-Kettering Cancer Center, 8000 members and is the principal organization of medical physicists in the
New York, NY, USA
United States.
4
University of Wisconsin-Madison, Madison,
WI, USA
The AAPM will periodically define new practice guidelines for medical physics
5
practice to help advance the science of medical physics and to improve the qual-
Calvary Mater Newcastle Hospital
University of Newcastle, Callaghan, Australia
ity of service to patients throughout the United States. Existing medical physics
University of Washington, Seattle, USA practice guidelines (MPPGs) will be reviewed for the purpose of revision or
6
Moffitt Cancer Center, Tampa, FL, USA renewal, as appropriate, on their fifth anniversary or sooner.
7
Tufts Medical Center, Tufts University School
Each medical physics practice guideline represents a policy statement by the
of Medicine, Boston, MA, USA AAPM, has undergone a thorough consensus process in which it has been sub-
8
Multicare Regional Cancer Center,
jected to extensive review,and requires the approval of the Professional Council.
Northwest Medical Physics Center, Tacoma, The medical physics practice guidelines recognize that the safe and effective
WA, USA use of diagnostic and therapeutic radiology requires specific training, skills, and
9
UC San Diego, California, USA techniques, as described in each document. Reproduction or modification of
10
University of Texas MD Anderson Cancer the published practice guidelines and technical standards by those entities not
Center, Houston, TX, USA providing these services is not authorized.
The following terms are used in the AAPM practice guidelines:
Correspondence (1) Must and must not: Used to indicate that adherence to the recommendation
Susan Richardson, Swedish Medical Center,
1221 Madison Street, Seattle, WA is considered necessary to conform to this practice guideline.
98103-5626, USA. (2) Should and should not: Used to indicate a prudent practice to which
Email: [email protected] exceptions may occasionally be made in appropriate circumstances.

Approved by AAPM’s Executive Committee April 28, 2022.

KEYWORDS
brachytherapy, HDR, MPPG, practice guideline

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided
the original work is properly cited.
© 2023 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, LLC on behalf of The American Association of Physicists in Medicine.

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2 of 18 RICHARDSON ET AL.

Table of contents 8.2.3. Plan normalization, weighting, and


scaling. . . . . . . . . . . . . . . . . . . 14
1. DEFINITIONS AND ACRONYMS . . . . . . . . 2 8.2.4. Dose calculation grid . . . . . . . . . 14
2. INTRODUCTION . . . . . . . . . . . . . . . . . . 3 8.2.5. Point dose calculations . . . . . . . . 14
2.1. Scope . . . . . . . . . . . . . . . . . . . . . 3 8.2.6. Dose display . . . . . . . . . . . . . . 14
2.2. Disclaimer . . . . . . . . . . . . . . . . . . . 3 8.2.7. DVH calculation. . . . . . . . . . . . . 14
2.3. Background . . . . . . . . . . . . . . . . . . 3 8.3. Miscellaneous commissioning tests . . . . 14
3. REGULATORY REQUIREMENTS . . . . . . . . 3 8.3.1. Optimization validation . . . . . . . . 15
3.1. RAM licensing . . . . . . . . . . . . . . . . . 4 8.3.2. TPS output . . . . . . . . . . . . . . . 15
3.2. Personnel monitoring. . . . . . . . . . . . . 5 8.3.3. Applicators and catheters . . . . . . . 15
3.3. Shielding . . . . . . . . . . . . . . . . . . . . 5 8.3.4. Independent dose calculation . . . . 15
3.4. Security . . . . . . . . . . . . . . . . . . . . 5 8.3.5. Dry run testing . . . . . . . . . . . . . 16
3.5. Transportation regulations. . . . . . . . . . 5 9. CONCLUSIONS. . . . . . . . . . . . . . . . . . . 16
3.6. Records . . . . . . . . . . . . . . . . . . . . 5 AUTHOR CONTRIBUTION . . . . . . . . . . . . . . 16
3.7. Periodic spot checks . . . . . . . . . . . . . 5 ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . 16
3.8. Training. . . . . . . . . . . . . . . . . . . . . 5 CONFLICT OF INTEREST . . . . . . . . . . . . . . 16
3.9. Patient treatment . . . . . . . . . . . . . . . 5 REFERENCES . . . . . . . . . . . . . . . . . . . . . 16
4. CLINICAL PRACTICE RECOMMENDATIONS . 6
4.1. Accreditation standards . . . . . . . . . . . 6
4.2. Professional societies . . . . . . . . . . . . 6 1 DEFINITIONS AND ACRONYMS
4.3. Manufacturers. . . . . . . . . . . . . . . . . 7
5. FACILITY . . . . . . . . . . . . . . . . . . . . . . . 7 ABR: American Board of Radiology.
5.1. Vaults . . . . . . . . . . . . . . . . . . . . . . 7 ABS: American Brachytherapy Society.
5.1.1. Dedicated suites . . . . . . . . . . . . 7 ACR: American College of Radiology.
5.1.2. Shared suites . . . . . . . . . . . . . . 7 AMP: authorized medical physicist—an individual
5.1.3. Operating room settings. . . . . . . . 7 who meets the requirements listed in 10 CFR § 35.
5.1.4. Mobile HDR units. . . . . . . . . . . . 7 ASTRO: American Society for Radiation Oncology.
5.2. Imaging resources . . . . . . . . . . . . . . 8 AU: authorized user—a physician who meets the
5.3. Patient management . . . . . . . . . . . . . 8 requirements listed in 10 CFR § 35 or is identified as
5.4. Transportation and immobilization . . . . . 8 an AU on a license or permit regarding medical use of
6. STAFFING . . . . . . . . . . . . . . . . . . . . . . 8 byproduct material.
6.1. Participants . . . . . . . . . . . . . . . . . . 8 CBCT: Cone Beam Computed Tomography.
6.2. Training and competency . . . . . . . . . . 9 CFR: Code of Federal Regulations.
6.3. Credentialing . . . . . . . . . . . . . . . . . 9 COMP: Canadian Organization of Medical Physicists.
7. HARDWARE. . . . . . . . . . . . . . . . . . . . . 9 CPQR: Canadian Partnership for Quality Radiother-
7.1. Treatment Delivery System QA . . . . . . . 9 apy.
7.1.1. Source positioning accuracy . . . . . 10 Dosimetrist: a qualified medical dosimetrist as
7.1.2. Timer accuracy . . . . . . . . . . . . . 10 defined by the Association of Medical Dosimetrists
7.1.3. Timer linearity. . . . . . . . . . . . . . 10 as “an individual who is competent to practice under
7.2. Source strength . . . . . . . . . . . . . . . . 10 the supervision of a qualified physician and qualified
7.3. Applicators and TGTs . . . . . . . . . . . . 11 medical physicist.”
7.3.1. Autoradiography . . . . . . . . . . . . 11 ESTRO: European Society for Therapeutic Radiology
7.3.2. Applicator and TGT length . . . . . . 11 and Oncology.
7.3.3. Source positioning . . . . . . . . . . . 11 GEC: The Groupe Européen de Curiethérapie.
8. SOFTWARE . . . . . . . . . . . . . . . . . . . . . 12 HDR: high dose-rate brachytherapy—refers to dose
8.1. Treatment planning imaging and tool QA . 12 rates higher than 12 Gy/h (ICRU381 ).
8.1.1. Image transfer . . . . . . . . . . . . . 12 IAEA: International Atomic Energy Agency.
8.1.2. Orientation . . . . . . . . . . . . . . . 13 ICRP: International Commission on Radiological Pro-
8.1.3. Labeling . . . . . . . . . . . . . . . . . 13 tection.
8.1.4. Geometric accuracy . . . . . . . . . . 13 IFU: instructions for use—instructions for use pro-
8.1.5. Image registration . . . . . . . . . . . 13 vided from the manufacturer of applicators or devices.
8.1.6. Source, point, and line delineation . . 13 IPEM: Institute of Physics and Engineering in
8.1.7. External device interface . . . . . . . 13 Medicine.
8.2. Treatment planning source validation and IORT: Intraoperative Radiotherapy.
dose calculation . . . . . . . . . . . . . . . . 13 NCRP: National Council on Radiation Protection and
8.2.1. Source model data . . . . . . . . . . . 14 Measurements.
8.2.2. Source decay . . . . . . . . . . . . . . 14 NRC: Nuclear Regulatory Commission.
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RICHARDSON ET AL. 3 of 18

PMI: preventative maintenance inspection. 2.3 Background


QA: quality assurance—as defined in the AAPM Task
Group 100 report: “QA confirms the desired level of Brachytherapy enjoys a long and rich history that tran-
quality by demonstrating that the quality goals for a task scends the practice of radiation therapy. Shortly after
or parameter are met.” the first observations of self -inflicted biological effects
QC: quality control—as defined in the AAPM Task by Henri Becquerel and Pierre Curie, the first encapsu-
Group 100 report: “QC encompasses procedures that lated radium source was provided by Pierre and Marie
force the desirable level of quality by evaluating the Curie to Henri-Alexandri Danlos in Paris (1903) for
current status of a treatment parameter, comparing dermatological therapies. Over a century of advances
the parameter with the desired value, and acting on and development followed this first implementation of
the difference to achieve the goal.” radiation therapy.2 The modern nuclear era, including
QM: quality management—as defined in the AAPM human-induced radioactivity, and the advent of the com-
Task Group 100 report: “QM consists of all the activities puter age allowed brachytherapy to transform from a
designed to achieve the desired quality goals.” manually delivered qualitative practice to an automated,
QMP: qualified medical physicist—as defined by quantitative one. Mechanical advances in remote source
AAPM Professional Policy 1. afterloading provided significant radiation dose reduc-
RAM: radioactive material. tion to providers. Additionally, the preference to reduce
TGT: transfer guide tube. in-patient stays, which had a concomitant need for
expensive, shielded medical units, led to the advent of
HDR brachytherapy. Similar to how intensity-modulated
2 INTRODUCTION radiation therapy (IMRT) advanced external beam radi-
ation therapy in the 1990s, HDR brachytherapy was the
The goal of this report is to assist the clinical medi- high-tech treatment modality that advanced the field
cal physicist in assuring that key quality metrics and of brachytherapy in the 1980s. However, many of the
practice considerations are met to ensure the safe, reli- reported drivers of HDR brachytherapy at the time were
able, and reproducible application of high-dose rate socio-economical. Similar to IMRT, HDR brachytherapy
(HDR) brachytherapy. This guideline has been devel- lacked prospective clinical trials to demonstrate the clini-
oped to provide appropriate minimum standards for cal benefits and questions regarding dose, fractionation,
such services. The secondary goal is to provide rec- and their related radiobiological considerations were
ommendations to the regulatory community from the expected to take years to answer.3
experts on this practice guideline to guide the adop- Today, HDR brachytherapy is a commonly used ther-
tion of regulations in the future. This MPPG is limited apeutic technique. It is a resource-intensive modality
to iridium-192-based HDR brachytherapy and will not with an oversight by applicable government regulation
discuss electronic, low-dose rate, pulsed dose rate and recommended practices by professional societies,
brachytherapy, or any alternative radionuclides. accreditation standards, and many others. The follow-
ing section provides an overview of guiding regulations,
clinical practice recommendations, and manufacturers’
2.1 Scope responsibilities that are applicable to the practice of
HDR brachytherapy.
This report has been divided into two parts. Part A
describes the infrastructure and program design in the
creation of an afterloader-based HDR brachytherapy 3 REGULATORY REQUIREMENTS
program. Part B (a separate, subsequent report)
describes the clinical treatment processes including The Code of Federal Regulations (CFRs) are general
imaging, planning, and treatment delivery. rules applied nationally and are organized under the
United States president through the executive branch.
Regulatory responsibility for radioactive material is the
2.2 Disclaimer responsibility of the Nuclear Regulatory Commission
(NRC) and is listed as Title 10 in the CFRs. Federal
It is the responsibility of all healthcare staff to be famil- law allows states to administer their own regulatory pro-
iar with state and federal guidelines that may take grams so long as they meet or exceed the requirements
precedence over American Association of Physicists in of the CFRs. These agencies are subject to periodic
Medicine (AAPM) recommendations that are provided review by the NRC to maintain Agreement State status.
in this report. Each health care facility may have site- Medical physicists practicing in agreement states must
specific or state-mandated needs and requirements that review their state regulations as they may differ from the
may modify their usage of these recommendations. federal ones.
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4 of 18 RICHARDSON ET AL.

TA B L E 1 Regulations and supporting references for implementation of an HDR brachytherapy program

Regulations References Topics covered

RAM licensing 10 CFR § 30 The process by which an organization or individual may


10 CFR § 33 receive a license entitling them to receive, possess, use,
transfer, or deliver RAM
Personnel 10 CFR § 20 Standards of protection for the public against exposure to
monitoring IAEA safety standards no. GSR Part 38 radiation and the limits of exposure for radiation workers
NCRP report no. 1169
Shielding NCRP report no. 495 Guidance on shielding design
IPEM report 7510
IAEA safety report series 4711
Security 10 CFR § 37 Specifies the requirements for physical protection of large
quantities of radioactive material
10 CFR § 20.1801 Specifies security of stored materials
IAEA nuclear security series no. 11-G12
10 CFR §35.610 Specifies security of HDR hardware and computers
Transportation and 49 CFR § 173 General transportation requirements for RAM
handling IAEA safety standards no. SSR-6 (Rev. 1)13
10 CFR § 71 Packaging, shipment, and transport of RAM
10 CFR § 20.1906 Receiving and opening of RAM
49 CFR § 172 Receiving or packaging RAM
Records 10 CFR § 30.51 Receipt, inventory, acquisition, transfer, and disposal
10 CFR § 40.61
Periodic spot 10 CFR § 35.643 Periodic spot checks for remote afterloader units
checks ICRP publication 9714
Training 10 CFR § 19 Notices, instructions, and reports by licensees and regulated
ICRP publication 97 entities to RAM workers
Patient treatment 10 CFR § 35.615 AMP presence during treatment
10 CFR § 35.604 Radiation surveys
10 CFR § 35.610 Emergency Procedures
ICRP publication 97
Abbreviations: AMP, authorized medical physicist; CFR, code of federal regulations; IAEA, International Atomic Energy Agency; ICRP, International Commission on
Radiological Protection; IPEM, Institute of Physics and Engineering in Medicine; NCRP, National Council on Radiation Protection and Measurements; RAM, radioactive
material.

The NRC oversees the licensing of all naturally When readily available, international publications have
occurring or accelerator-produced materials (NARM) also been listed. All CFR reports can be accessed at
including nuclear reactor-produced materials. This lat- nrc.gov.
ter material is known as byproduct material. Title 10 Beyond the borders of the United States, most
CFR §37 describes physical protection of Category 1 sovereign nations have implemented regulations to
and Category 2 quantities of radioactive material (RAM). guide the use of radioactive materials. In support of
NRC defines these sources as “risk-significant sources” the peaceful use of atomic energy, the International
and they are listed in an IAEA publication.4 Most users Atomic Energy Agency (IAEA) was founded by the
will not trigger Category 2 requirements of greater than United Nations in 1957. It provides guidance and tech-
21.6 Ci or 799.2 GBq (for Ir-192) of contained activity nical cooperation for 172 member nations and partners
unless they have multiple afterloaders. However, newer worldwide.Its primary mission is to promote safe,secure,
afterloaders have better shielding and higher activity and peaceful nuclear technologies. In this light, the IAEA
sources (10–15 Ci), so each facility is responsible for assists in defining technical standards for the use of
evaluating their total on-site activity with regards to the radioactive and byproduct material some of which are
security of their sources and licensing requirements. listed in Table 1.
Due to potential variations in specific rules for the
current agreement states, the regulations in the fed-
eral register (i.e., the CFRs), which represent minimum 3.1 RAM licensing
compliance expectations, will be discussed in the sub-
sequent sections (I–VIII) where appropriate. Table 1 Any healthcare facility offering brachytherapy services
summarizes the legal references and topics discussed. must have a radioactive materials license that allows
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RICHARDSON ET AL. 5 of 18

them to receive, possess, utilize, and transport such around the receipt of RAM. Licensees must perform a
sources. This license becomes a mechanism by which wipe test within 3 h of the receipt of normal form RAM
the regulatory agency can supervise the use of radioac- during business hours (or by the beginning of the next
tive source and byproduct material and ensure that business day if delivered after hours) to assure that
licensees comply with applicable regulations.5 there were no leaks or spills of the material in tran-
sit by examining the packing for contamination. Some
HDR sources are sent as special form RAM and may
3.2 Personnel monitoring be exempted from wipe testing requirements (see 10
CFR § 20.1906). The AAPM virtual library contains two
Personnel monitoring for radiation workers is only excellent overviews of this training.6
required if there is an expectation that staff receives
greater than 10% of the regulatory limits; however,
brachytherapy providers should be actively monitored in 3.6 Records
the event of an emergency response.
The current regulations regarding source or by-product
material state that the records must be maintained for
3.3 Shielding the receipt, duration of possession, and the transfer or
disposition of the material for three years. Additionally,
There are no specific US regulations regarding shielding records for spots checks and surveys must be kept for 3
design or requirements, with the exception that shield- years. More details can be found in 10 CFR § 30.51 and
ing must be installed to ensure that the requirements 10 CFR § 40.61.
for radiation exposure to personnel and members of
the public in 10 CFR § 20 are met. National Council on 3.7 Periodic spot checks
Radiation Protection and Measurements (NCRP) report
No. 49 offers guidance on structural shielding design for This section will be addressed in Section 7.1.
gamma rays up to 10 MeV, which would include iridium-
based HDR. A regulatory agency may require review
and approval of shielding plans prior to the construction 3.8 Training
of a new facility or modification of an existing one.
Training of staff will be addressed in Section 6.2.

3.4 Security
3.9 Patient treatment
Source security is defined as a set of measures required
to prevent unauthorized access, damage, loss, theft, or Due to the rate of dose delivery in HDR brachytherapy,
unauthorized transfer of radioactive sources. NRC and an authorized medical physicist (AMP) and authorized
Agreement States established “a multilayered, compre- user (AU) must be physically present for the initiation of
hensive security program” to protect these sources. The all patient treatments. The AMP must remain immedi-
licensee must generate policies and procedures that ately available for the entire duration of treatments; a
govern the storage and transfer of radioactive mate- physician with training in emergency procedures may
rial to ensure compliance with this standard as per 10 replace the AU for the remaining duration of the treat-
CFR § 37. For example, designated storage areas and ments. The interpretation of physical presence was later
enhanced security measures may be helpful for compli- clarified as being within hearing distance of normally
ance. Regarding source receipt, the licensee is expected spoken voice.7 Additionally, AMPs and other involved
to expeditiously take possession of the package. This personnel must participate initially and annually in an
should require creating a lockable storage area where emergency drill. While most HDR brachytherapy sys-
packages are received before they can be surveyed and tems do not merit the enhanced physical security
transferred to a secure storage area. requirements listed in 10 CFR § 37, if the licensee
chooses to implement enhanced security practices (e.g.,
electronic door locks with biometric access) then the
3.5 Transportation regulations medical physicist must evaluate their potential role in
an emergency response to assure that the patient can
Shippers and transporters must receive specialty train- be quickly reached in the event of a system failure
ing in these regulations every 3 years to assure (e.g., power loss) or medical emergency (e.g., a cardiac
compliance (see 10 CFR §172). Licensees must estab- arrest). More information regarding these topics will be
lish processes to comply with specific requirements given in Part B of this practice guidance report.
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6 of 18 RICHARDSON ET AL.

4 CLINICAL PRACTICE TA B L E 2 Selected societal guidance documents on HDR


brachytherapy
RECOMMENDATIONS
Year pub-
4.1 Accreditation standards Topic Reference lished

General HDR AAPM report 4115 1993


There are multiple groups that provide practice accred- brachytherapy
AAPM report 4616 1994
itation to hospitals and free-standing radiation therapy QA/QC/QM
programs AAPM report 5917 1997
clinics. The accreditation may be used as a demon-
stration of the ability to meet specified standards and AAPM report 6118 1998
may be used in advertising efforts. Accreditation may ASTRO/PRO special article19 2014
be obtained by the American College of Radiology IAEA 2D to 3D20 2015
(ACR), the American Society for Radiation Oncology COMP/CPQR quality guidelines21 2018
(ASTRO) through the Accreditation Program for Excel- NCS code of practice22 2018
lence (APEx), or through the American College of Radi-
ACR/ABS/ASTRO practice 2020
ation Oncology (ACRO). To receive accreditation, sites parameter23
must demonstrate compliance with the accreditation
ACR/AAPM technical standard24 2020
standards set by the various organizations. At present,
there is no regulatory requirement or implication for Dosimetric AAPM and ESTRO report 22925 2012
formalisms
accreditation. and
consensus
data
4.2 Professional societies Uncertainties in AAPM/GEC-ESTRO report 13826 2011
brachytherapy
GEC-ESTRO/AAPM review27 2014
As a service to their members and to protect and ben-
efit members of the public, professional societies may Treatment AAPM report 6228 1998
planning CPQR quality guidelines29 2018
prepare guidance documents. The AAPM has produced
over 100 guidance reports on a variety of topics includ- Model-based AAPM report 18630 2012
ing HDR brachytherapy,and other aligned societies have dose
also published guidelines and recommendations for calculation
HDR brachytherapy including ASTRO, ACR, American Surface AAPM/GEC ESTRO report 25331 2020
Brachytherapy Society (ABS), and European Society brachytherapy
for Therapeutic Radiology and Oncology (ESTRO). A Safety and risk ICRP prevention of accidents32 2005
wide variety of international entities have also generated analysis
AAPM report 28333 2016
methodology
guidelines that may be useful. A summary of documents ASTRO safety is no accident34 2012 and
that may be of use to HDR practitioners is found in 2019
Table 2. Abbreviations: AAPM, American Association of Physicists in Medicine; ABS,
The AAPM has published numerous reports that American Brachytherapy Society; ACR, American College of Radiology; ASTRO,
American Society for Therapeutic Radiation Oncology; COMP, Canadian Orga-
address HDR brachytherapy in a variety of ways. Sev- nization of Medical Physicists; CPQR, Canadian Partnership for Quality
eral reports include quality assurance (QA) recommen- Radiotherapy; ESTRO, European Society for Therapeutic Radiology and Oncol-
dations for remote afterloaders, sources, applicators, ogy; GEC, The Groupe Européen de Curiethérapie; HDR, high-dose rate
brachytherapy; ICRP, International Commission on Radiological Protection; NCS,
and treatment planning systems (TPS). These form Nederlandse Commissie voor Stralingsdosimetrie; QA, quality assurance; QC,
the basis for most institution-specific QA programs. Of quality control; QM, quality management.
note, the most recent of these reports was published
in 1998, showing that it has been nearly 20 years since that may be of interest to HDR brachytherapy physi-
quantitative QA performance benchmark recommen- cists. COMP has published recent quality control (QC)
dations were defined by the AAPM for brachytherapy. guidelines for remote afterloaders, among other per-
Report 283 (known as the report of TG-100) introduced tinent recommendations. Helpful guidance documents
the concept of risk-analysis methods in the formation may also be found by other national organizations, such
of quality management (QM) protocols. There are also as the Netherlands Commission on Radiation Dosime-
educational resources from the AAPM Brachytherapy try group and the Australasian College of Physical
Summer School publications from 1994, 2005, 2013, Scientists and Engineers in Medicine, among others.
and 2017, which cover a wide variety of topics. While hundreds of guidance documents may inform
Clinicians may also refer to other national professional readers, health care facilities should follow their own
societies to draw from their experience and benefit internally defined and approved practices. Internal pol-
from their recommendations such as ESTRO and Cana- icy should outline key rules and requirements, while
dian Organization of Medical Physicists (COMP). These an associated procedure should describe the steps to
groups have sponsored a large number of publications ensure that policy goals are met.
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RICHARDSON ET AL. 7 of 18

4.3 Manufacturers maze and doorway will facilitate patient transport on a


gurney.
Vendors that market and sell medical equipment in the
United States must comply with Food and Drug Admin- 5.1.2 Shared suites
istration (FDA) regulations. The FDA is organized under
the Department of Health and Human Services in the Due to space limitations, especially within an exist-
executive branch. Regulations governing the lifecycle ing facility, it may not be possible to have a dedicated
of medical devices are located in Title 21 of the CFR, HDR brachytherapy suite. While this obviates the need
from preclinical use to labeling requirements. Medical to shield a room specifically for brachytherapy, regu-
device vendors have a responsibility to inform users of lations require the presence of interlocks to prevent
issues identified with a specific medical device. These the accidental use of the linac or simulator during a
typically take place as a Notice to Users or a Field brachytherapy treatment (and vice versa). While most
Change Order in the event that service is required, and linac vaults provide adequate shielding for a new HDR
the notices may require acknowledgment of receipt by brachytherapy source, a survey for hot spots or shield-
the end user. Users may be required to provide informa- ing defects should still be performed.35 Additionally, the
tion and access to a vendor in the event of a medical afterloader must be properly stored and secured in the
device malfunction. Maintaining contact with the vendor, treatment vault to comply with any state or federal reg-
for example, through a service contract, ensures that ulations. If shared with a simulator room to facilitate
users receive critical notifications and safety upgrades imaging, the patients should be imaged and treated on
and that preventative maintenance is performed as a non-radiopaque table. Retrofitting an imaging suite
recommended. Users should also ensure they have for brachytherapy may be expensive due to shield-
current copies of manufacturers’ instructions for use ing requirements. Information on the implementation of
(IFU) that define proper use, sterilization requirements HDR brachytherapy in a limited resource setting can be
(if applicable), and the product lifecycle. found elsewhere.36

5 FACILITY 5.1.3 Operating room settings

5.1 Vaults Intraoperative procedures where applicator insertion,


imaging, planning, and treatment are performed in one
The most common location of an HDR brachytherapy session under anesthesia are becoming increasingly
afterloader is in a dedicated vault or suite in which the common. Situating an afterloader in an operating room
unit is stored permanently and the patient is treated. An can allow for efficient treatment at the time of surgery,
alternative is to use another pre-existing shielded area but can introduce other complicating factors such as
of the hospital, such as a linac or imaging vault. Depend- increased training of nonradiation oncology personnel,
ing on the types of procedures performed at a facility, the need to interlock and shield multiple doors, addition
HDR brachytherapy in an intraoperative radiotherapy of warning lights and radiation monitors, and storage
(IORT) environment may require treatment in another and security of the afterloader.37 In the rare event of
department’s operating room. Each solution presents its an emergency, the patient may be under anesthesia
own unique challenges and benefits. and dependent on life support equipment and may not
be able to be moved out of the procedure or operating
room. Instead, the HDR afterloader (or source) must
5.1.1 Dedicated suites be isolated from the patient. This can be achieved
if a small shielded enclosure is constructed as part
A dedicated suite is the easiest solution as the patient of the room and serves both as an emergency con-
may wait in the vault during treatment planning and there tainer of the source and attached applicator(s) and
may be no competing procedures which require the as a secured routine storage area of the afterloading
movement of the patient. Equipment storage is usually unit.38 Additional challenges of this environment include
available through built-in cabinetry allowing QA devices, high-pressure treatment planning time constraints as
applicators, and transfer guide tubes (TGTs) to be stored anesthesia duration should be minimized, and operating
near the treatment area. Shielding should be designed room time is costly.
specifically for HDR radionuclide energy ranges and is
generally less costly than shielding for a linac vault. 5.1.4 Mobile HDR units
In the design phase, care should be taken to evaluate
patient procedures that require ancillary devices and It is possible to transport an HDR unit between multiple
equipment such as overhead lighting, surgical lighting, locations or to house an HDR unit in a shielded van. This
access to oxygen and anesthesia equipment, radio- may increase the ability to treat patients who otherwise
graphic needs, patient monitoring, and so forth. A wide could not travel for treatment. Ten CFR §35.2080 covers
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8 of 18 RICHARDSON ET AL.

TA B L E 3 Summary of facility types for HDR brachytherapy thesia or conscious sedation requires independent
treatments monitoring of the patient. If the patient is to be treated
Imaging while under anesthesia, vital signs must be monitored
Location Advantage Challenge devices from outside the treatment vault. Typical installations
Linac or Existing Storage, patient CT will include two independent cameras with one that can
simulator shielding and scheduling, CBCT be fixed onto the anesthesia equipment for monitoring.
vault space, hardware kV imaging Patients can also be medicated orally for pain and anx-
minimization interlocks ultrasound iety relief, which does not require additional monitoring
of patient
of the patient by trained personnel.
transport after
imaging
Dedicated Access, storage, Shielding cost, CT
suite patient timing space Portable 5.4 Transportation and immobilization
(brachy limitations, CT
only) patient CT on rails The absence of dedicated treatment suites with in-room
transportation CBCT imaging requires patients to be transported from the
if no in-room MR
area of applicator placement and/or imaging to the treat-
imaging kV imaging
ultrasound ment area. This can involve many separate movements
of the patient, especially if the applicator is placed in
Operating Access Shielding, Variable
room storage, an operating room. Proper training of staff as well as
multiple dedicated equipment to move the patient can help mit-
interlocks igate applicator or needle migration or displacement. If
possible, the applicator should also be fixed in place
with respect to the patient through the use of external
mobile medical services and is not be discussed further fixation. Options include external fixation devices, spe-
in this report. cial brachytherapy underwear, and homemade devices.
A summary table of advantages and challenges of Interstitial templates may be sutured to the patient, and
various facility types with optional imaging devices is glue or dental putty may be used to keep catheters
shown in Table 3 below: and needles in place. Commercial patient transport sys-
tems for the movement of brachytherapy patients can
be helpful. Regardless of the immobilization and trans-
5.2 Imaging resources port method, the patient should be imaged as close
to treatment initiation as possible to confirm applicator
In order to appropriately plan the HDR treatment, the
positioning.
patient should be imaged with the applicator in situ.
When the HDR unit is located in a facility that
Placement of the afterloader within a linear accelera-
is not attached to the health care facility where the
tor treatment vault can permit the use of the linac’s
applicator is placed, an ambulance service may be
imaging capabilities such as kV imaging and CBCT.Ded-
necessary to transport the patient. Regardless of the
icated brachytherapy suites can use a variety of imaging
distance involved, this type of transport can pose some
devices, such as a portable CT scanner, portable C-arm,
challenges: coordination and timing of transportation,
CT-on-rails, MR, or even an MR-on-rails. Both surface
support staff for transportation depending on pain con-
and intracavitary ultrasound can be utilized to assist in
trol methodology, type of anesthesia used for applicator
applicator placement as well as being used for plan-
placement, and applicator movement during transfer.
ning, such as in HDR prostate brachytherapy. The most
common setting is a departmental CT scanner with
patient transfer to the HDR treatment room. The physi-
6 STAFFING
cist should make best use of the imaging resources
available. For example, obtaining an MR scan during the
6.1 Participants
course of cervical brachytherapy can be performed at
a scanner located outside of the department either with
The brachytherapy treatment team may consist of a
or without the applicator in place.39,40 More information
multitude of different members including AU, resident
about treatment planning imaging and options will be
physician, AMP, physics resident, dosimetrist, nurse, ther-
provided in Part B of this report.
apist, and interdepartmental members like a breast
surgeon or anesthesiologist. Together, this team should
5.3 Patient management be informed about the particular patient and work in a
collaborative manner toward the ideal patient treatment.
In addition to the radiotherapy and imaging resources, This requires good communication and standardization
patients need to be medically managed. Use of anes- of policy and procedures.
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RICHARDSON ET AL. 9 of 18

The radiation oncologist is generally present, and the treatment unit and treatment planning system should
physicist or dosimetrist should be present during the be performed for all relevant staff involved in the HDR
placement of the treatment applicator. The presence brachytherapy program. This is particularly true for new
of interdepartmental personnel for applicator placement programs. Additionally, on-site training for the first few
will depend upon the policies and procedures at each cases of each treatment site should be attended by both
health care facility and the complexity of the patient the vendor and the treatment team. This includes both
treatment. Staffing needs may vary based on the type of a new afterloader facility, or new complex applicators
sedation used, such as full or conscious sedation. Mem- such as multicatheter breast brachytherapy or intersti-
bers outside of the radiation oncology team who may tial brachytherapy. Training must be documented, and
be needed for certain procedures include, but are not the documentation should include the training scope as
limited to anesthesiologists, scrub technicians, circula- well as a list of the individuals present.
tor nurses, or other medical doctors such as gynecologic
oncologists, breast surgeons, or urologists.
An AU and an AMP must be present for the initia- 6.3 Credentialing
tion of HDR brachytherapy. Members of the treatment
team who may be present during the treatment proce- Credentialing of staff can be complex and involve dif-
dure, but whose attendance is not mandatory include ferent departments and agencies. Medical staff is often
dosimetrists,nurses,and therapists.Additional members credentialed when newly hired.Training and licenses are
of the treatment team who may be present for appli- verified as part of the local hospital credentialing office
cator placement and/or treatment delivery, but who are in order to grant hospital privileges. To use radioac-
not required,include trainees such as radiation oncology tive material and be identified as an AU or AMP on a
or medical physics residents, and dosimetry or radia- RAM license, credentialing is commonly granted by the
tion therapy technology students. Treatment should be Radiation Safety Committee, the NRC, the Agreement
delivered in compliance with local regulations and facility State, or a combination of these entities. The radiation
policies. oncology department may also have its own workflows
in order to credential or deem individuals as compe-
tent to participate or perform an HDR brachytherapy
6.2 Training and competency procedure independently. In some instances, this may
involve proctoring and supervision of a defined num-
The federal and state regulations outline the specific ber of cases and may be site-specific. Each health care
education and training requirements for individuals hold- facility should develop an on-boarding procedure and
ing the titles of AMP, AU, and RSO (radiation safety associated documentation that includes how an individ-
officer). These requirements must be followed even if ual will demonstrate knowledge for the different types of
not articulated in this report as they are beyond the procedures performed locally. Each individual should be
scope of this MPPG. Additionally, individuals involved in responsible for reading the policies and procedures of
an HDR brachytherapy program must hold the appro- the brachytherapy program, observing and performing a
priate (advanced) degree for their specialty. With a predetermined number of cases under supervision, and
few exceptions, individuals must be board certified by demonstrating competency. This on-boarding process
the appropriate specialty board which may include the should be documented and maintained by the health
American Board of Radiology (ABR),American Board of care facility. Government-run health care facilities, such
Medical Physics (ABMP), Medical Dosimetry Certifica- as the Veterans Affairs health system, may have other
tion Board (MDCB), or American Registry of Radiology applicable rules that must be understood and followed
Technologists (ARRT). Team members must be licensed by the AMP. Annual refreshers or in-services as well
if employed in a state that requires licensure (FL, HI, NY, as annual competency evaluations may be helpful in
or TX). maintaining proficiency.
Regulations also outline the minimum expected initial
and continuing education requirements for participants
involved in an HDR brachytherapy program. Addi- 7 HARDWARE
tionally, such participants (not previously described)
should participate in emergency training, an emergency 7.1 Treatment Delivery System QA
response drill, HDR-specific radiation safety training,
and in-service training on an annual basis. Annual train- Broadly defined as “afterloader QA,” the following sec-
ing should be completed on all relevant equipment, tions describe the minimum frequency and tolerances
including the remote afterloader, applicators, transfer of a variety of tests required to ensure ongoing func-
tubes, and the treatment planning software. The work- tionality of the console area, the afterloader, as well
flow for each procedure should be reviewed annually. as specific tests to be performed during commission-
Vendor-supplied or vendor-supported training of the ing. Commissioning tests must be performed before
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10 of 18 RICHARDSON ET AL.

TA B L E 4 HDR brachytherapy afterloader QA with periodicity tained. Daily QA must be performed after any repair
and tolerance service to the afterloader. A discussion on appropriate
Tolerance source strength measurement methods also follows in
recom- Section 7.2. Items marked with a Roman numeral in the
mended Table are further explained in the sections that follow.
Periodic test description Frequency (required)

Source strength measurement SE 3% (5%)


Source positioning accuracyI SE, D 1 (2) mm 7.1.1 Source positioning accuracy
Source retraction with backup SE Functional
battery upon power failure The NRC required tolerance value of 1 mm may be diffi-
Timer accuracyII SE, D 1 s or 1% cult to achieve in a variety of applications but should be
whichever verifiable under a fixed test geometry that is used during
is greater source exchange. Since the source must be measured
Timer linearityIII AS 1% (3%) within a TGT that itself can only be measured to an accu-
Electrical interlocks at room SE, D Functional racy of 1 mm, a more practical tolerance value may be 2
entrance (door interlock(s)) mm as adopted by the report of TG-56 and COMP. The
Emergency source retraction SE, D Functional overall source position accuracy should be 1 mm and
button must be 2 mm.
“Last person” out button (if SE, D Functional
present)
Treatment interrupt button SE, D Functional 7.1.2 Timer accuracy
Source out indicators on the unit, SE, D Functional
console, wall, and so forth The timer on the console computer must be accurate
to deliver the intended radiation dose to the patient.
Audio/visual systems D Functional
The dwell time minimum threshold for various after-
Emergency response kit complete D Functional
loaders may be as low as 0.1 s, which cannot be
Independent radiation room D Functional verified via conventional means. One method to check
monitor and remote display
for gross errors is to use an independent stopwatch or
Calibrated survey meter present D Functional timer and deliver a fixed treatment time (using a rea-
Console computer date and time SE, D, 1h sonable clinical time where disparities due to human
accuracy Daylight reflexes are negligible). The accuracy must be within
time
1 s or 1% (whichever is greater) under these fixed test
changes
conditions.
Decayed source strength (or SE, D 1%
activity) in console (compared
to decay chart)
Catheter D Functional
7.1.3 Timer linearity
misconnect/channel/turret
check The dwell time linearity must be validated over at least
TPS to console software SE Functional three treatment times where transit time (typically 1–2 s)
communication is insignificant. For example, the well chamber reading
Abbreviations: AS, after service; D, daily (on patient treatment day); SE, source with a 60-s dwell must be twice the reading of a 30-s
exchange. dwell (to within 3%). If one accounts for and removes
the reading due to transit time, the agreement may be
closer to 1%. The linearity should not change over time
beginning clinical treatments and all tests in Table 4 unless the afterloader motor is adjusted for example, at
must be performed at this point. All ancillary equipment a PMI.
and accessories such as printers, barometers, clamps,
and so forth, must be tested prior to use. In cases
where the afterloader console is integrated with patient 7.2 Source strength
record and verify systems, that communication must
be validated at commissioning as well. An alternative The air-kerma strength of each 192 Ir source used for
plan transfer method should also be in place in case a HDR treatments must be accurately determined and
network disruption occurs to ensure that patients can be properly accounted for in each treatment. Upon receipt
treated timely and correctly. Vendors may perform pre- and installation of a new 192 Ir HDR source,the air-kerma
ventative maintenance inspections (PMIs) on an annual strength value will be provided by the manufacturer in a
or biannual basis, depending on the manufacturer and calibration certificate with a specific reference date and
service contract. Evidence of the PMI should be main- time. It is the responsibility of the user to verify this value
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RICHARDSON ET AL. 11 of 18

upon receipt of the source by performing measure- TA B L E 5 Applicator and transfer guide tube tests with frequency
ments using a calibrated well-type ionization chamber and tolerance
and electrometer. The well-chamber determined value Tolerance
must agree with the manufacturer’s source certificate’s recom-
value (both decay corrected to a reference date and mended
Test description Frequency (required)
time) to within 5% although typical agreements are
closer to 3%.41 If the measurement is outside of this Visual inspection of D Pass/Fail
agreement criteria, investigation into the possible rea- integrity of applicators,
tubes, and connections
sons must immediately be pursued. It is recommended
(used that day) by AU or
to check the reference date, the recorded ambient air AMP
conditions (temperature and pressure), and most recent
Autoradiography (if C Baseline
well chamber calibration coefficient before contacting possible)I
the manufacturer. It is uncommon for the difference to
Length of applicator and A, D (see text), C 1 mm (2 mm)
be greater than 5%, so treatments must not proceed TGT combinationII
until this discrepancy is resolved. Either vendor or insti-
Connection of source C Pass/Fail
tutional value may be used if it is applied consistently. TGTs, applicators, and
In the United States, the well-type ionization chamber transfer-tube interfaces
and electrometer should be calibrated by an Accredited Geometric integrity of C Pass/Fail
Dosimetry Calibration Laboratory (ADCL) at least once applicator
every 2 years with traceability to the National Institute Verification of source path C Baseline
of Standards and Technology (NIST). The well-chamber and any offsets
must have a holder specific for an HDR source catheter Confirmation of match C 1 mm (2 mm)
and the same holder must be used for the ADCL cali- between solid applicator
bration as well as the end user’s clinical source strength library and physical
measurement. The maximum reading of a source dwell applicator
position inside the well chamber should be determined Source positioning within As needed Baseline
by means of stepping the source in small increments certain applicatorsIII
through the well-chamber holder to find the position Abbreviations: A, annually; C, commissioning; D, daily (on day of use).

where the highest ionization current is produced. This


is commonly referred to as the well chamber sweet spot advent of solid applicator libraries, the users may have
and is unique to each well chamber and source holder. more confidence in vendor-provided offsets.

7.3 Applicators and TGTs 7.3.2 Applicator and TGT length


Applicator commissioning and QA rely on a variety of In general, if applicators are solid metal or plastic and
physical, imaging, and radiological tests to ensure posi- the TGTs are stored properly, the lengths of the applica-
tional, temporal, and dose delivery accuracy. In general, tor and TGT combination will rarely change more than 1
these tests are described in the AAPM Report 59.17 mm. All applicators and tubes that are in clinical rotation
The tests in Table 5 describe the QA tests that must be should be checked on at least an annual basis and com-
performed and refer to multi-use (i.e., not sterile single- pared to the commissioning baseline. The applicator +
use) applicators and TGTs. Items marked with a Roman TGT length should be checked prior to treatment initi-
numeral in the Table are further explained in the sections ation or at least once prior to a fractionated treatment
that follow. where the applicators are not removed between frac-
tions. As this is one of the most common HDR errors,43
site-specific recommendations will be given in part B of
7.3.1 Autoradiography this guideline.

Autoradiography used to be the standard method of


confirming the active source positioning within the appli- 7.3.3 Source positioning
cator and validation of any planning off -sets. However,
due to many clinics becoming “film free,”this has become Certain applicators may be highly sensitive to the
more challenging. Alternatives may still be possible positioning of the HDR source, which may change
using either C-arms or Linacs (particularly electron slightly over time and with repeated active runs and/or
beams) and radiochromic film.42 Care should be taken source exchanges. Examples may include tandem and
to properly identify the source path and locations within ring, complex gynecological applicators, conical skin
the applicator and any offsets characterized. With the applicators, and some shielded applicators. This may
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12 of 18 RICHARDSON ET AL.

affect the output (for conical applicators) or dose dis- these applicators are often MR-safe. Commissioning
tribution surrounding the applicators when a PMI or and validation of applicator geometry and function must
source exchange occurs. For these applicators, the IFU be performed and documented for each applicator, as
regarding QA should be followed and tests should be described above. Further guidance may be provided in
performed to ensure consistent dose delivery. If deter- the forthcoming report of TG-336 or other published
mined to be a reasonable approximation, offsets over works on 3D printing applications.44
multiple source exchanges and afterloaders can be Geometric accuracy of shielded applicators must be
averaged and used for clinical use. A good discussion verified after applicator assembly. A CT scan should
of source positional accuracy may be found in Kirisits be performed at commissioning to understand appli-
et al.27 cator geometry with and without shields in place.
Dynamic shields must be tested for functionality and
Applicators and TGT combination length measurements reproducibility.28 If shielding orientation is marked on the
must be performed annually while in routine use. A fail- applicator, it should be checked for correctness. Solid
ure mode and effects analysis or similar review could be applicators and the solid applicator library comparison
performed to inform the basis for more practical period- will be discussed in the treatment planning QA section
icity for those devices, which are found to not change and in Table 8.
with time. Part B of this report will discuss patient treat-
ment aspects regarding treatment length for planning
purposes. Applicator and transfer tube combinations 8 SOFTWARE
that have not been used in the past year should be
tested prior to clinical use. It is also good practice to 8.1 Treatment planning imaging
annually verify the accuracy of the adjustable length and tool QA
gauge and/or length measurement devices if applicable.
Single-use or one-time-use devices are considerably Treatment planning software commissioning tasks are
different in that they are often supplied by the manufac- designed to ensure that the new software package
turer sterile and may already be placed in a patient by handles clinical tasks such as image manipulation,
the time the patient presents for treatment in the facility. structure delineations, and dose calculation correctly
The specific patient handling aspects for these devices and some tests will need to be conducted to provide
will be handled in part B of this report.It is recommended a baseline for periodic checks such as annual QA.
that the AMP performs QA and testing with a nonsterile Software used for HDR brachytherapy treatment plan-
test device prior to clinical implementation. Some appli- ning may be dedicated to a specific HDR afterloader.
cators come nonsterilized and can be tested prior to In addition, various software packages exist to accom-
sterilization. For patient treatments, the combined length modate specific brachytherapy procedures. Interfaces
of the applicator and transfer tube must be measured with ancillary devices (such as an ultrasound stepper,
and documented at least once per device. etc.), configuration, networking, and workflow perfor-
Manufacturer specifications for end of life should be mance should be tested prior to the clinical use of the
followed as articulated in the IFU. However, using an software. New commissioning must be performed for
applicator beyond its stated end of life may be con- each new release of the software in addition to vendor-
sidered under some circumstances if care is taken to required testing. Routine clinical use of the software in
ensure the integrity of the applicator and mechanical an active brachytherapy program will reduce the need
functioning. Vendors recuse themselves from liability for repeated testing as loss of functionality or network
when equipment is used beyond end-of -life recom- connections would be noticed with normal use.
mendations. If the applicator exceeds the number of Imaging systems and treatment applicators used in
sterilization cycles, material fatigue and infection control HDR brachytherapy may result in imaging artifacts or
may become an issue. distortion, which may lead to incorrect patient dose.45,46
Homemade applicators (machined or 3D printed) add While a full discussion of artifacts is beyond the scope of
flexibility and the possibility to customize applicator this report, care should be taken to minimize and under-
geometry to the patient. The burden of establishing stand various imaging limitations. The imaging tests
biocompatibility for the materials used (especially if that must be performed (required) for TPS commission-
used interstitially or surgically), cleaning, and steriliza- ing include the recommendations in Table 6 and are
tion procedures must be determined by the hospital discussed in the text below:
team. Because of the high cost of validating repeated
cleaning and sterilization cycles between patients, these
applicators are typically single-use. Applicator design 8.1.1 Image transfer
and material selection should also reflect the imaging
modality intended to be used for planning and treat- Useability of images and image sets imported and
ment verification. Usually made of a plastic material, exported from the software including DICOM format and
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RICHARDSON ET AL. 13 of 18

TA B L E 6 HDR brachytherapy TPS imaging and planning tool active area of research and the registration and
validation tests dosimetric errors may be large, for example, when
Tolerance registering an image set without the applicator in situ
recommended to an image set containing an applicator.52,53
Test description (required) Required

Image transfer and Pass/Fail ✓


reconstruction 8.1.6 Source, point, and line delineation
Patient orientation Pass/Fail ✓
Labeling Pass/Fail ✓ Point delineation should be accurate to within 1 mm
when compared with DICOM coordinates. Both 2D and
Geometric accuracy Modality-dependent ✓
(see text) 3D structure interpolations and expansions should be
checked. Reference lines and reference points can be
Image registration Modality-dependent
(see text) used as surrogates to structure contours and may be
used for dose optimization and evaluation. 3D defini-
Contouring Functional
tion of the line and point coordinates should be verified.
Source, point, and line 1 mm (2 mm)
Structures may be contoured with the use of Boolean
delineation
operators that should be verified to be performing
External device interfaces Functional
correctly.
(e.g., steppers)

live video acquisition. Images should maintain quality 8.1.7 External device interface
and be free of distortion or degradation.
Some dedicated planning and delivery systems offer
an option for interfacing with external devices. New
8.1.2 Orientation devices are continually being developed to enhance the
safety and consistency of treatments. Examples include
Patient orientation is correctly displayed on images electronic and robotic steppers for prostate implants,
acquired using fixed imagers, mobile imagers, and navigational devices for spine brachytherapy, and elec-
non-DICOM image acquisition methods where patient tromagnetic tracking. Functional and operational checks
orientation is not included in the image data. of these devices should be performed but specific QA
tests are beyond the scope of this guidance report.

8.1.3 Labeling
8.2 Treatment planning source
Transfer of image data including image identifiers, validation and dose calculation
acquisition parameters, and imager information.
Prior to TPS commissioning, a qualified medical physi-
cist (QMP) must select the dose computation algo-
8.1.4 Geometric accuracy rithm(s) to be used clinically. The QMP should have
a clear understanding of the algorithm(s) chosen, the
The accuracy of the imaging set depends on the modal- source model parameters, and how each option affects
ity of the images. CT image accuracy should be within the resulting dose distributions. There are a variety of
1 mm in-plane47 and 2 mm elsewhere while MR should commercial and noncommercial brachytherapy treat-
be within 2 mm48,49 and ultrasound should be within 2 ment planning systems and a given TPS may include
mm or 2%.50 multiple dose calculation algorithms. The AAPM cur-
rently recommends using a modified AAPM report of
TG-43 dosimetry formalism for clinical dose calcula-
8.1.5 Image registration tion as defined in AAPM Report 22925 (subsequently
referred to as Report 229), which uses tabulated data
Rigid registration is most widely used. Multiple scans to allow calculation of point doses and 3D dose dis-
of the same phantom in different orientations can tributions. The tests for source validation and dose
be aligned and evaluated. Quantitative errors can calculation accuracy are provided in Table 7. Model-
be measured in some systems using point-to-point based dose calculation algorithms (MBDCAs) are also
matching between imaging sets and evaluating the commercially available and the AAPM report of TG-186
target registration error. Achievable target registration provides recommendations for commissioning these
errors should be in the 2–3-mm range.51 Deformable algorithms.54 Practice guidelines for MBDCA commis-
image registration for brachytherapy is currently an sioning are beyond the scope of this report. Due
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14 of 18 RICHARDSON ET AL.

TA B L E 7 HDR brachytherapy TPS source validation and dose 8.2.3 Plan normalization, weighting, and
calculation tests
scaling
Tolerance
recom- Treatment plans are often improved by adjusting iso-
Test mended Required
dose distributions globally or locally. Changing the
description Frequency (required) test
number of fractions or prescribed dose can also scale
Source C, Aa Exact ✓ the dwell times. Treatment times should be cross-
model checked to validate the correct scaling of the planned
dataI
time.
Source C, SE 1% ✓
decay (if
possible)II
Plan normal- C Functional ✓
8.2.4 Dose calculation grid
ization/
weighting/ Brachytherapy treatments often involve small calcula-
scalingIII tion volumes and dose accuracy can depend on the
Dose C Functional calculation grid size used. A large calculation grid may
calculation influence DVH calculations, particularly maximum point
gridIV doses within a contour. Typically, the dose grid resolution
Point dose C, Aa 2% (3%) ✓ may be set at 0.1–0.3 cm per dimension.
calculation
(single
source)V
Point dose C 3% (5%)
8.2.5 Point dose calculations
calculation
(multisource)V Either the source model data or a point dose calculation
Dose display C Functional may be verified on an annual basis as these two tests
(absolute investigate the same process. Users may wish to cre-
and ate a fixed geometry test plan and compare dosimetry
relative)VI annually. If MBDCAs are to be used, dose consistency
DVH C Functional ✓ with AAPM Report 229 based calculations should be
calculationVII verified as well as inhomogeneity and scatter modeling
Abbreviations: A, annual; C, commissioning; SE, source exchange.
a accuracy.
Perform either test––see discussion in 8.2.5.

to possible dosimetric implications on the treatment 8.2.6 Dose display


prescription, MBDCAs should not be used clinically with-
out rigorous validation and substantial brachytherapy The dose should display in both absolute (Gy) and rel-
experience. ative (%) doses. If applicators with shields are to be
used, a methodology for documentation and isodose
line reduction should be incorporated into the planning
8.2.1 Source model data guidelines if using the Report 229 formalism.

Source reference data used by the brachytherapy TPS


must be appropriate for the source type used for 8.2.7 DVH calculation
treatment delivery. It is recommended that consensus
datasets from Report 229 are used for dose calcula- According to the report of TG-53, DVH analysis
tions. When checking source parameters in a TPS, the should be performed at least annually. However, for a
input data must correspond exactly with the published brachytherapy TPS, the user is required to validate func-
consensus dataset for that source. tionality rather than accuracy. Interested users may use
the methodology of Gossman et al.55

8.2.2 Source decay


8.3 Miscellaneous commissioning
Some treatment planning systems allow the user to tests
account for radioactive decay. This should be checked
with an independent calculation or other validation Additional tests for software commissioning that should
method. or must be performed are included in Table 8. Some
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RICHARDSON ET AL. 15 of 18

TA B L E 8 HDR brachytherapy TPS commissioning tests

Treatment planning test Tolerance recommended Required


description Test specifics (required) test

Optimization validationI Manual dwell time/weight Functional


Dose shaper/graphical Functional
optimization
Geometric optimization Functional
Inverse planning Functional
TPS output validationII Printer or pdf function Functional
Data transfer integrity Functional ✓
Applicators and cathetersIII Solid applicator geometry 1 mm (2 mm) ✓
Source position 2 mm (3 mm) ✓
Depends on applicator and
modality
Shielding Functional
Independent calculationIVa Dose calculation Functional
Dry run validationV Basic end-to-end testing Functional ✓
a
Optional test.

tests may be vendor-specific and may not apply to all dwell position representation of a particular applicator
brachytherapy TPS, in which case the requirement is that may be imported into the planning system. Free
waived. hand needle and catheter reconstruction may require
image interpolation and rotations.
The TPS may have tools to assist with auto-
8.3.1 Optimization validation segmentation of the source path. These tools should
be checked, and their limitations documented. For exam-
Optimization of HDR brachytherapy treatment plans ple, noisy images, crossing of catheters/needles, use of
can occur in several ways, including, but not limited to, dummy wires, high curvature of the catheters, or use
manual dwell time or weight adjustments, dose shaper of non-CT images may impair correct detection of the
or graphical optimization, geometric optimization, and source path.CT range finders may be used for applicator
inverse planning algorithms. Assessment of optimiza- delineation and should also be evaluated for function-
tion should occur for each available optimization method ality. Digitized/reconstructed source positions within the
and should be completed for each treatment or appli- applicator should be within +/−2 mm of true source
cator type in clinical use in the department where positions. However, this limit may not be appropriate
appropriate. depending on the applicator and modality type used.

8.3.2 TPS output 8.3.4 Independent dose calculation

Treatment plan document verification as well as integrity In HDR brachytherapy, an independent treatment time
testing of data transfer from the TPS to treatment unit calculation has historically been performed to verify that
must be completed. the total dwell times and/or dose distribution is consis-
tent with the specified arrangement including source
positions, strength, and dwell times. There are a number
8.3.3 Applicators and catheters of commercial checking programs available, however,
these secondary programs rely on DICOM input from
For applicators with known geometry or applicators the TPS for secondary calculations and typically cannot
with template/solid applicator libraries, visualization and find planning errors. Software that performs indepen-
digitization/reconstruction must be verified and should dent dose calculations based on independent implant
agree to the known geometry within +/−1 mm by reconstruction has been reported,56 as have script-
superimposing a CT image of the applicator onto the based algorithms and other software packages that
geometrical representation of the applicator. A “solid” check for consistency of the plan with prescription, as
applicator refers to a vendor provided geometric and well as other electronic medical record parameters and
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16 of 18 RICHARDSON ET AL.

quality indices.57 The recommendation of this practice an adequate management plan. Disclosures of poten-
guideline is that any secondary dose calculations should tial Conflicts of Interest for each member of TG348
be optional as they lack true independence or are oth- are found at the close of this document. The mem-
erwise not readily available or practical. Any adopted bers of TG348 listed below attest that they have no
independent system can be verified using the TG53 potential Conflicts of Interest related to the subject
methodology (Appendix 5).28 They should be used with matter or materials presented in this document. Susan
care to ensure that dose calculation has not been cor- Richardson, PhD, Chair; Ivan Buzurovic, PhD; Wesley
rupted within the TPS, and only after implant geometry Culberson, PhD; Claire Dempsey, PhD; Bruce Libby,
and plan parameters have been independently verified. PhD;Christopher Melhus,PhD;Robin Miller,MS;Saman-
Other independent treatment time calculations (e.g., tha Simiele, PhD. The members of TG348 listed below
nomograms, Manchester and Quimby tables) may also disclose the following potential Conflict(s) of Interest
be valuable tools for HDR plan QA. Depending on the related to subject matter or materials presented in this
type of implant these methods can typically predict a document. Daniel Scanderbeg, PhD––Varian Medical––
plan total dwell time with an accuracy of 5–10%. A speaker/consultant Merit Medical––speaker/consultant;
secondary dose calculation is separate from an inde- Gil’ad Cohen, MS––Varian Medical––speaker.
pendent plan check that will be addressed in more detail
in part B.
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