IAEA-TECDOC-1040

XA9848503

Design and implementation of aradiotherapy programme:
Clinical, medical physics, radiation
protection and safety aspects

INTERNATIONAL ATOMIC ENERGY AGENCY

J\

29-49

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FOREWORD
The incidence of cancer in the world is increasing, particularly in relation to prolonged life
expectancy from worldwide improvements in standards of living. According to recent estimates of
the International Agency for Research on Cancer (IARC) and the World Health Organization(WHO), approximately nine million new cancer cases are being detected per year worldwide, withslightly more than half of the cases occurring in developing countries. By the year 2015 this number
is expected to increase to about 15 million cases, of which two thirds will occur in developing
countries. About half of all cancer patients receive radiotherapy, either as part of their primary
treatment or in connection with recurrences or palliation.
Radiotherapy is a multidisciplinary speciality which uses complex equipment and radiation
sources for delivery of treatment. It is estimated that approximately 2500 teletherapy machines are
currently installed in developing countries, where the cancer incidence is about 75-150 cases per
100 000 inhabitants. This figure is significantly below the estimated needs of almost 5000 machines,
based on a rate of approximately one machine per every 500 new cases of cancer. A conservative
estimate points at a need of about 10000 machines by the year 2015. Although this figure might
appear difficult to achieve, the number of treatment units in developing countries is increasing
considerably. The number of brachytherapy sources and devices is increasing at a similar rate as
well. With this in perspective, in addition to the enormous need for qualified professionals (radiation
oncologists, medical physicists, radiotherapy technicians, radiation protection officer, maintenanceengineers, etc.) capable of operating new radiotherapy equipment, the development of the medical
infrastructure for cancer treatment appears to be a substantial undertaking in forthcoming years.
It is widely acknowledged that the clinical aspects (diagnosis, decision, indication fortreatment, follow-up) as well as the procedures related to the physical and technical aspects of patient
treatment must be subjected to careful control and planning in order to ensure safe, high quality
radiotherapy. Whilst it has long been recognized that the physical aspects of quality assurance inradiotherapy are vital to achieve an effective and safe treatment, it has been increasingly
acknowledged only recently that a systematic approach is absolutely necessary to all steps withinclinical and technical aspects of a radiotherapy programme as well.
The need to establish general guidelines at the IAEA, taking into account clinical, medical
physics, radiation protection and safety considerations, for designing and implementing radiotherapy
programmes in Member States has been identified through the Member States' increased interest in
the efficient and safe application of radiation in health care. Several consultants and advisory groupmeetings were convened to prepare a report providing a basis for establishing a programme inradiotherapy.
The present TECDOC is addressed to all professionals and administrators involved in thedevelopment, implementation and management of a radiotherapy programme in order to establish acommon and consistent framework where all steps and procedures in radiotherapy are taken into
account. The IAEA staff members responsible for this publication were P. Ortiz-Lopez (NSRW) and
P. Andreo (RIHU).

EDITORIAL NOTE
In preparing this publication for press, staff of the IAEA have made up the pages from theoriginal manuscripts as submitted by the authors. The views expressed do not necessarily reflect
those of the IAEA, the governments of the nominating Member States or the nominatingorganizations.
Throughout the text names of Member States are retained as they were when the text wascompiled.
The use of particular designations of countries or territories does not imply any judgement by
the publisher, the IAEA, as to the legal status of such countries or territories, of their authorities
and institutions or of the delimitation of their boundaries.
The mention of names of specific companies or products (whether or not indicated asregistered) does not imply any intention to infringe proprietary rights, nor should it be construed
as an endorsement or recommendation on the part of the IAEA.

CONTENTS
1.

INTRODUCTION.......................................................................................................... 1

1.1.
2.

PROGRAMME DESIGN AND IMPLEMENTATION FLOW.................................... 4

2.1.

2.2.

2.3.
3.

Programme design................................................................................................. 4
2.1.1. Assessment of national needs and countrywide distribution ofradiotherapy facilities.................................................................................. 4
2.1.2. Assessment of institution's clinical needs ................................................... 4
2.1.3. Assessment of institution's resources.......................................................... 5
2.1.4. Programme formulation .............................................................................. 5
Programme implementation................................................................................. 6
2.2.1. Staff training................................................................................................ 6
2.2.2. Equipment specification.............................................................................. 6
2.2.3. Facility planning and construction.............................................................. 7
2.2.4. Equipment delivery ..................................................................................... 7
2.2.5. Planning and initiation of the treatment...................................................... 8
Follow-up and assessment..................................................................................... 8

STAFF REQUIREMENTS FOR A RADIATION THERAPY PROGRAMME .......... 8
3.1.
3.2.

4.

Global cancer burden and the need for radiotherapy ............................................ 1

Hospital administrators..........................................................................................
Radiotherapy staffing............................................................................................
3.2.1. Patient load assessment...............................................................................
3.2.2. Staff ............................................................................................................

9
9
9
9

RADIOTHERAPY FACILITY DESIGN....................................................................... 17
4.1.

4.2.

4.3.

External beam therapy........................................................................................... 17
4.1.1. Examination rooms...................................................................................... 17
4.1.2. Simulator room............................................................................................ 17
4.1.3. Treatment planning room............................................................................ 17
4.1.4. Mould room................................................................................................. 18
4.1.5. Treatment room........................................................................................... 18
4.1.6. Waiting areas............................................................................................... 18
Low dose rate (LDR) brachytherapy..................................................................... 18
4.2.1. Source storage and preparation room.......................................................... 19
4.2.2. Operating room............................................................................................ 19
4.2.3. Treatment planning room............................................................................ 19
4.2.4. Patient room ................................................................................................ 19
4.2.5. Additional requirements for LDRremote-afterloading............................... 19High dose rate (HDR) brachytherapy.................................................................... 20
4.3.1. Options........................................................................................................20
4.3.2. Operating room............................................................................................ 20
4.3.3. Outpatient surgery room.............................................................................. 21
4.3.4. Treatment planning room............................................................................ 21
4.3.5. Treatment room.......................................................................................... 21

5.

EQUIPMENT................................................................................................................. 21
5.1. Introduction........................................................................................................... 21
5.2. Equipment for external beam radiotherapy........................................................... 22
5.2.1. Simulator..................................................................................................... 22
5.2.2. Treatment planning equipment.................................................................... 22
5.2.3. Teletherapy unit...........................................................................................225.2.4. Quality assurance equipment....................................................................... 22
5.2.5. Radiation safety equipment......................................................................... 225.3. Equipment for brachytherapy................................................................................ 22
5.3.1. Imaging equipment...................................................................................... 23
5.3.2. Equipment for treatment planning............................................................... 23
5.3.3. Treatment delivery equipment..................................................................... 23
5.3.4. Quality assurance equipment....................................................................... 24
5.3.5. Equipment for radiation safety and source handling................................... 25

6.

QUALITY ASSURANCE OF THE RADIOTHERAPY PROGRAMME AND
PATIENT RADIATION PROTECTION....................................................................... 25
6.1. Clinical aspects of the quality assurance programme........................................... 26
6.1.1. Treatment policies....................................................................................... 26
6.1.2. Clinical case conferences for review of proposed/recent patient
treatments.................................................................................................... 26
6.1.3. Clinical follow-up and statistical review..................................................... 26
6.2. Physical aspects of the quality control programme............................................... 26
6.3. Radiotherapy planning and delivery...................................................................... 27
6.3.1. Initial evaluation.......................................................................................... 27
6.3.2. Therapeutic decision.................................................................................... 28
6.3.3. External beam radiotherapy......................................................................... 28
6.3.4. Brachytherapy .............................................................................................29
6.4. Maintenance programme....................................................................................... 30
6.4.1. Preventive maintenance...............................................................................31
6.4.2. Repair.......................................................................................................... 31
6.4.3. Spare parts................................................................................................... 31
6.5. Investigation of accidental medical exposures...................................................... 31
6.6. Quality audits ........................................................................................................ 31

7.

RADIATION PROTECTION AND SAFETY OF SOURCES ..................................... 32
7.1. General..................................................................................................................32
7.2. Organization and managerial measures................................................................. 32
7.2.1. Management policy..................................................................................... 32
7.2.2. Staffing and training.................................................................................... 32
7.2.3. Reassessment of training needs................................................................... 33
7.3. Description of equipment and sources .................................................................. 33
7.4. Facility layout, shielding and interlocks................................................................ 34
7.4.1. External beam.............................................................................................. 34
7.4.2. Brachytherapy ............................................................................................. 35
7.5. Individual monitoring............................................................................................ 36
7.6. Classification of areas ........................................................................................... 36

7.7. Rules and supervision............................................................................................ 36
7.7.1. Procedures for external beam therapy......................................................... 36
7.7.2. Procedures for brachytherapy...................................................................... 36
7.7.3. Supervision..................................................................................................38
7.8. Accident prevention .............................................................................................. 38
7.9. Emergency plans ................................................................................................... 39
7.9.1. Lost source .................................................................................................. 39
7.9.2. Stuck source ................................................................................................ 39
7.9.3. Contamination............................................................................................. 39
7.9.4. Patient accidental exposure......................................................................... 39
7.9.5. Staff irradiation............................................................................................39
APPENDIX A: RESPONSIBILITIES OF THE RADIATION ONCOLOGIST AND
THE MEDICAL PHYSICIST........................................................................ 41
APPENDIX B: SPECIFICATIONS FOR A TREATMENT SIMULATOR.......................... 43
APPENDIX C: EQUIPMENT REQUIREMENTS FOR COMPUTERIZEDTREATMENT PLANNING SYSTEMS ....................................................... 47
APPENDIX D: SPECIFICATIONS FOR A 60Co TELETHERAPY UNIT AND ITSRADIATION SOURCE................................................................................. 51
APPENDIX E: BASIC EQUIPMENT RECOMMENDED FOR DOSIMETRY IN
EXTERNAL RADIATION THERAPY........................................................ 55
APPENDIX F: COMPARISON BETWEEN HIGH-DOSE-RATE (HDR) AND LOWDOSE-RATE (LDR) BRACHYTHERAPY.................................................. 57
APPENDIX G: SPECIFICATION OF EQUIPMENT FOR REMOTE LDR AND HDR
AFTERLOADING BRACHYTHERAPY.....................................................59
APPENDIX H: LICENSING...................................................................................................63
APPENDIX I: CONSIDERATIONS FOR A QUALITY ASSURANCE PROGRAMMEIN RADIATION ONCOLOGY..................................................................... 73

APPENDIX J: RADIATION SHIELDING FOR EXTERNAL BEAM FACILITY ............. 87
REFERENCES.........................................................................................................................91
CONTRIBUTORS TO DRAFTING AND REVIEW.............................................................. 93

RECENT IAEA PUBLICATIONS ON CLINICAL, MEDICAL PHYSICS,
RADIATION PROTECTION AND SAFETY ASPECTS OF RADIOTHERAPY................ 95

1. INTRODUCTION
During the last few years there has been an increased demand from Member States for theInternational Atomic Energy Agency (IAEA) to provide assistance, including the provision ofradiation sources and equipment, in establishing radiotherapy programmes for the treatment ofcancer patients. This is usually made through the Technical Co-operation (TC) projects. The
provision of this assistance and equipment without a systematic approach to ensure clinical,
dosimetnc, safety and maintenance aspects could jeopardize the outcome of the treatment of thepatient (with either unacceptably high complication or recurrence rates), and might result in an
unacceptable risk of accidents. In addition, all projects carried out with the assistance of the IAEA
must be in compliance with the International Basic Safety Standards for Protection against Ionizing
Radiation and for the Safety of Radiation Sources (BSS) [I]. The present report has been
produced so that the IAEA staff, expert consultants, or missions and their counterparts from IAEA
Member States, will have a consistent and systematic approach to establishing and upgrading aradiotherapy programme. It covers both "External Beam Radiotherapy" with MCo teletherapy unitsand "Brachytherapy."

1.1 GLOBAL CANCER BURDEN AND THE NEED FOR RADIOTHERAPY
According to estimates made by the International Agency for Research on Cancer (IARC)
there are currently (1990 estimate) more than nine million new cancer cases per year world-widewith slightly more than half of the cases occurring in developing countries. By the year 2015 thisnumber is expected to increase to about 15 million cases, of which two-thirds will occur indeveloping countries.
The distribution of cancer cases between the sexes world-wide is fairly even 4.77 million
cases occurring in males and 4.55 million cases in females. Since the incidence of cancer increases
by age, the majority of new cases occur in the age group 65+ years. The age distribution of cancer is,
however, quite different in developed and developing countries; there are significantly more cancer
cases in childhood, adolescence and young ages in the developing countries, while cancer in theelderly still dominates in developed countries (Figure 1).
2500 T

2000./

ISQO-/

1000

500--

0-14

15-44

45-54

55-64

65+

FIG. 1. Age distribution of cancer cases in developed and developing countries 1990 In the age group0-14 yrs there are 5 times more cases in the developing countries and in the age group 15-45 almost 3
times more (IARC 1990 estimate, by courtesy of DM. Parkin, IARC, Lyon).

Overall, the most common tumour world-wide is cancer of the lung, with an annual
incidence of almost 1.2 million cases, followed by stomach cancer (0.90 million), breast cancer

(0.84 million), colorectal cancer (0.80 million) and cancer of the mouth and pharynx (0.51 million)(Figure 2a). In males the most common tumour is cancer of the lung, followed by stomach (Figure2b). In females, breast cancer is the most common tumour type, followed by cancer of the cervix(Figure 2c).

Total

Lung
StomachBreastColon-Rectum
Mouth-Pharynx
Liver
Cervix uten

Oesophagus
Prostate

Lymphoma
Bladder

Leukemia
Pancreas
Ovary
Larynx105

Corpus uten

FIG. 2a. World-wide distribution of cancer types 1990, ranked by total number of cases forvarious diagnoses. (IARC 1990 estimate, by courtesy ofD.M. Parkin, IARC, Lyon).

MaleDeveloped

Developing

countries500

fOO 300 200

countries
100

100 200 300 WO 500

I , I , I , I
472

417 Lung

356

StomachColon-Rectum
Prostate
Mouth-Pharynx
Liver
Oesophagus

Bladder
Lymphoma
Larynx

Leukemia
Pancreas
KidneyMal Melanoma
Myeloma

FIG 2b. World-wide distribution of cancer types 1990, ranked by total number of cases forvarious diagnoses for males. (IARC 1990 estimate, by courtesy ofD.M. Parkin, IARC, Lyon).

Female500400

Developed

Developing

countries

countries

300

200

100

0

100

200

300 400500

I I I , I , I I I I I I I I I I I I I I I
1367
|371

BreastCervixuten
Colon-Rectum

S tomach
Lung

Ovary
Mouth-Pharynx

Corpus uteri
Liver
Oesophagus
Lymphoma
Leukemia
Pancreas

Bladder
KidneyMal Melanoma
Myeloma
LarynxFIG.

2c. World-wide distribution of cancer types 1990,

various diagnoses for female. (IARC 1990

ranked by total number of cases for

estimate, by courtesy ofD.M. Parkin, IARC, Lyon).

The incidence of different cancer types varies considerably among regions, and examples
involving the most common tumour types in males and females are given here. Female breast cancer
reaches high incidence rates in the USA,slightly lower rates in Western Europe, and the lowest
rates being reported from Eastern European countries, Asia, and Africa. Cancer of the cervix is theleading female cancer in developing countries. In males, lung cancer shows the highest rates in the
Maoris of New Zealand and black populations of the USA;the lowest rates are seen in India andAfrica. A similar pattern is seen for female lung cancel'. Stomach cancer in males has high rates in
the Far East, median rates in eastern Europe, and low rates in the USA.
Populations migrating from one country to another with a very different cancer pattern, tend
to approach the incidence rates of their new home country. This effect has been studied extensively,
especially for populations from the Far East moving to California.
It should be recognized that incidence data will change over time due to a number of factors,
real or apparent. The most important real factor is demographic change, in particular, ageing of the
population due to elimination of diseases causing early death. This will inevitably lead to anincreased number of cancer cases. Real factors are also true changes in cancer incidence due tochanges of life-style, socio-economic development, and exposure to environmental agents. Amongthe factors apparently raising incidence figures are the increasing awareness of cancer diseases in
the population; availability of diagnostic procedures (this also includes the introduction of screening
programs which will increase the incidence, albeit temporarily), and improvement in cancer
registration techniques. Due to the interplay of all these factors, the rates of change varyconsiderably throughout the world.
The most obvious example of real change in cancer incidence is the alarming increase oflung cancer, in particular in developing countries due to the acquisition of smoking habits. Other
examples of real increase in incidence are observed in breast cancer and melanoma, breast cancer
incidence now approaching that of cervical cancer in developing countries. Gastric cancer, the mostcommon type of cancer ten years ago, is decreasing world-wide.
The pattern of cancer has a profound influence on the need for radiotherapy in a particularcountry. The high incidence of a certain tumour type in some populations, such as cancer of thenasopharynx, also may influence the need for specific radiotherapy resources in a region.

An advisory group in 1993 [17] estimated that "approximately 2300 megavoltage
teletherapy units are currently installed in developing countries, primarily cobalt-60 units. In thesecountries, the typical incidence of new cancer patients is 75 to 150 per 100,000 population. To servea current population of 4.4 billion, assuming 4.4 million new cancer cases per year, 50% of which
requiring radiotherapy, and assuming one machine per 500 new cancer cases treated, the current
need is for a total of 4,400 machines. By the year 2015, barring a dramatic and unforeseen cure forcancer, a total of 10,000 machines will be needed to provide treatment for an estimated 10 million
new cancer cases per year in developing countries." For comparison, "the number of megavoltage
machines per I million of population ranges from 8.2 in the USA to 3.4 fn the UK, with 70-90%
of the machines being electron accelerators."

2. PROGRAMME DESIGN AND IMPLEMENTATION FLOWThis section outlines the flow of analysis and activities for initiating a new radiation therapy
programme (external beam and/or brachytherapy) or enhancing the capabilities of an existing
programme. Emphasis is placed upon developing a comprehensive programme that addresses allelements of such a programme, including adequate professional personnel and essential
infrastructure needs as well as specific equipment and training needs. The institution's clinical andtechnical needs should be identified.

2.1 PROGRAMME DESIGN
A systematic approach is applied for designing a radiotherapy programme. All of these steps
should be considered in detail.
2.1.1

Assessment of national needs and countrywide distribution of radiotherapy facilities

The projected annual number of patients needing radiation therapy should be assessed as
described below. If no national register on cancer is available, this should be extrapolated fromcountry population and age distribution using as much regional hospital data as available. The siting
and facilities in individual radiotherapy departments should be compared to the national population
distribution.
The benefits to patients of a wider national distribution of radiation oncology facilities atother regional hospitals with adequate diagnostic and surgical infrastructure should be carefully
evaluated before embarking on expansion of an existing department.
2.1.2

Assessment of Institution's Clinical Needs

Surgery, radiation therapy and systemic chemotherapy remain the basis of the managementof patients with cancer. A radiotherapy department should be integrated in a comprehensive cancer
treatment programme. The projected annual number of patients needing radiation therapy should beassessed as described in Section 3.2.1. Useful data sources include hospital admission records fromprevious years, stated patient numbers from the institution's radiation oncologists and otheroncology physicians, and demographic data characterizing the hospital's client population. Other
relevant information includes enthusiasm of current and potential referring physicians for enhanced
radiation therapy capability and deficiencies in existing referral patterns and treatment policies. The
raw patient accrual data should be stratified according to tumour site, stage, and other presentation
factors required to define the needs for different types of radiation therapy. The result of thisanalysis should be a projected annualized rates of accrual of patients requiring various types ofradiation therapy (external beam and/or brachytherapy) as part of their treatment. If the requirements
for radiation therapy are not well known by the institute's counterpart radiation oncologist andphysicist, sending an appropriately pre-project mission is highly indicated.

2.13 Assessment of Institution's Resources

The institution's current capability for handling the clinical need should be carefully
assessed including:a) Professional and technical personnel, including radiation oncologists, medical physicists andother medical subspecialists (i.e., surgical, medical, pathologists and gynaecologic oncologists)needed. In assessing the adequacy of radiation oncology professional staffing, the total
workload of the department for both external beam therapy and brachytherapy should beconsidered.
b) Status of existing programme infrastructure, including radiation protection, quality assurance,and clinical peer-review and policy formulation programmes outlined in Section 3.
Shortcomings and steps to resolve them should be identified at this time and included as part ofthe project.
c) The status and character of any existing radiotherapy programme (external beam andbrachytherapy), including patient numbers and procedure types, and quality assurance
processes.
d) Existing capital resources including operating rooms, treatment delivery equipment, treatment
planning equipment (planning system and imaging systems), and dosimetry equipment.
e) Hospital administration commitment and/or government for funding capital and programme
operating expenses.
f) Library facilities with access to the appropriate clinical and scientific journals.
2.1.4 Programme Formulation

A initial evaluation should be developed which describes all resources (personnel,
equipment and space renovation) required to realize the identified clinical needs such that theresultant programme conforms to the minimal standards of practice outlined in Section 3. This
involves comparing the programme needed to carry out the clinical aims according to the practicestandards of Section 3 with the existing resources, and identifying additional needs. The options
selected will depend on many factors: patient load, clinical training, biases and the institute's
interest, and availability of funds. Especially with technically advanced treatment equipment, a costbenefit analysis that demonstrates that the proposed facility meets the institute's goals in terms ofpatient work load, clinical capability, and institutional resources available to support the programmeshould be prepared.
The initial evaluation should include the following elements:a) A description of the radiotherapy programme, including patient capacity and the facility
required.
b) Major pieces of equipment, additional personnel, and major space renovation or construction
should be briefly described. The division of costs, between the institution and its sponsors
should be addressed.
c) Additional personnel needed should be described and justified according to Section 3. Emphasisshould be placed on having adequate professional radiation oncology staff (physicians andphysicists) to support the radiotherapy programme without jeopardizing other programmes.
d) Institutional deficiencies (quality assurance, radiation protection, maintenance, etc.) should be
described and an action plan outlined for correction of the deficit.
e) Equipment needs (teletherapy machines, simulators, sources, remote afterloaders, planningsystems, etc.) should be described in enough detail that a budget can be prepared.
f) The need for external training of the radiation oncology professional staff (physicians,
physicists and technicians). Describe the need for on-site technical experts for training andhelping to manage programme implementation and monitoring its progress. External training ofcounterpart personnel should be identified.
g) All major construction and space renovation should be described in detail,h) A plan for equipment acquisition and commissioning should be developed consistent with thetraining of staff.

i)

A plan for clinical implementation including procedure and quality assurance programme
development, training of ancillary personnel, and programme initiation should be developed.
j) An overall work plan or time line, describing the sequence of detailed equipment specificationand facility planning, construction, equipment delivery, acceptance and commissioning andclinical implementation should be developed including expert services and training programme.
The co-ordination of these activities with expert consultants should be addressed.
k) Finally, a master budget should be prepared. The entity (hospital administration, country
government) responsible for funding each major item should be identified. The institutionscommitment to the project, including funding, must be included.

2.2 PROGRAMME IMPLEMENTATIONThis section describes the process of implementing the programme, following acceptance,
and includes training, equipment specification, detailed design and construction of the physicalfacilities, commissioning and initiation of patient treatments.

2.2.1 Staff Training
Early in the process, a decision should be made about additional training required for thehospital staff. A plan to train these personnel before the equipment installation should be developed.
This plan should include who will be trained, the host institution that will provide the training, andwhen the training will occur. Resources invested early in training may well pay significant dividends
later, improving the efficiency of the later planning and implementation.
Refer to Section 3 for a discussion of the training required for the staff physician(s) and physicist(s).
Note the preference for having the physician and physicist trained in the same host institution and at
the same time.
Training may also be necessary for maintenance technicians and support personnel.
It must be realized that a high standard in radiotherapy can only be achieved and maintained by fulltime specialists. It involves team approach and close collaboration with all the specialists, including
pathology, involved in the diagnosis and treatment of cancer.
2.2.2 Equipment Specification

Refer to Section 5 and Appendix B - G for a complete description of the types of equipment

needed. The teletherapy machine, simulator, radioactive sources, remote afterloading device (if any),
applicators, treatment planning system, dosimetry equipment, quality control equipment, andradiation protection instruments will need to be specified and arrangements made for their purchasein a cost-effective manner.
2.2.2.1 Contractual Considerations

Elements that are important to the life of the equipment and to safety should be addressed
early in the planning stage and be included in contractual form, such as:a) Compliance with quality and safety standardsb) Acceptance tests and conditions to correct deficiencies revealed during acceptancec) Warranty conditionsd) Enforceable assurances on availability of maintenance support, factory support, manuals andspare parts.
e) Possible training of local engineers.
It is suggested that at least 50% of the contract price be withheld until completion of the
programme has been accepted by an expert.

2.2.3 Facility Planning and Construction
The process of finalizing the detailed plan of the facility will involve many steps and will
depend upon whether this is a new facility or the remodelling of an existing facility. These are
outlined here in general terms in a reasonable sequence, but any actual planning process needs to beflexible and iterative. The planning may involve external experts, but must always involve the local
hospital staff who will be actually performing the radiation therapy treatments, as well as
representatives of the local funding agency, such as the hospital administration and the equipment
manufacturer.
2.2.3.1 A rchitectural and Constructional Drawings

Refer to Section 4 for a complete description of facility design issues. The layout of the
facility should be planned considering equipment requirements, water and electrical utilities needed,
room shielding required and climate control. Careful attention must be focused on the flow ofpatients in the treatment facility. The layout should be planned in accordance with internationallyaccepted radiation safety standards and in consultation with the radiation oncologist, physicist andthe equipment manufacturer.
2.2.3.2 Licensing

The radiotherapy installation needs to be licensed by the National Regulatory Authority. As
a radiotherapy installation needs major construction, it is most likely that Regulatory Authorities inMember States shall provide authorization before construction begins. Therefore the application fora license must be prepared at an early stage. It should contain all the relevant elements to assure theRegulatory Authority that the planned facility will be safe. An example of a detailed outline of theelements for a license is given in the Appendix H.

2.2.3.3 Scheduling
The delivery of equipment should be co-ordinated with the construction schedule. The
teletherapy machine and radioactive sources may not be delivered until the facility is ready toreceive them safely. The staff must have completed training and be prepared to receive theequipment also.
Equipment that is needed to test and commission the teletherapy unit, the radioactive
sources and afterloading device should arrive early enough to be tested before use.
The arrival of technical expert(s) should be scheduled so that all the necessary equipment ispresent, the facility is prepared, and the staff is ready to make use of the expertise.
2.2.3.4 Construction

During the construction phase, there must be individual(s) on site with the knowledge andauthority to supervise and inspect the construction. This person must have sufficient training, which
may have been received from agency experts, to check the specialized requirements of theradiotherapy facility.

2.2.4 Equipment Delivery

A number of important steps must be taken before, during, and immediately after theequipment arrives. These will typically be done by the local staff with help from an outside expert, if
necessary. It is recommended that the expert assists the local staff to develop procedures, equipment
test, etc. The expert should not directly do the work, since the local staff must develop the expertiseand confidence to carry on after the expert's departure.

2241

Acceptance Testing and Commissioning

Radiation sources need to be safely received, registered and stored, the radiation
measurement equipment tested and calibrated, the shielding of special rooms measured, the radiation
sources tested and calibrated, and the remote afterloader (if any) and teletherapy unit (if any)
commissioned
It is best to have the specific procedures for all of these steps worked out and written inadvance The record-keeping system should also be in place The time required to accomplish all
this preparation can be substantial, measured in weeks or months It may be possible to do some ofthe preparatory procedure writing in parallel with the training and facility planning steps
Once the procedures are written and the equipment is on site, actual testing andcommissioning of the facility, equipment, sources, etc , can be accomplished This entire process
will be lengthy as well, again taking several weeks Refer to Section 6.2 for details
2242 Quality Control and Radiation Safety Procedures

After the commissioning has been finished, the specific tests needed for ongoing quality
control and radiation safety assurance will need to carried out Refer to Section 6 and Appendices IJ for details
2.2.5

Planning and Initiation of the Treatment

2.2.5 1 Clinical Procedure Design
The radiation oncologist will determine the overall treatment techniques and specifictreatment procedures keeping in mind that those procedures evolve in time The physicist will needto prepare the technical work instructions associated with each type of treatment, such as proceduresfor calculation of doses and treatment times, source handling, associated quality control steps, etc
Section 6 has more details on these requirements
The importance of careful planning for each type of radiotherapy treatment must be
appreciated by all, since the correct execution of the treatment is the purpose of the entire
programme.

2252 Training and Rehearsal

Before actually treating any patients, staff will need to be trained in the treatment
procedures, and each type of treatment should be rehearsed in detail Any omissions or problems
with the treatment procedures can then be identified and corrected

2 3 FOLLOW-UP AND ASSESSMENT
Some months after treatments have begun, the Agency arranges for a follow-up visit by anexpert to assess the programme and, if needed, recommend changes The expert should participate in
the daily routine to properly assess the performance of the equipment and the professionals involved
in its use

3. STAFF REQUIREMENTS FOR A RADIATION THERAPYPROGRAMMEThis Section covers in detail the various staff required in a radiation therapy programme
The overall purpose is to give the Agency, the expert on a mission, and the institute's counterpart acomprehensive view so that the entire project can be designed and implemented in a manner thatbest assures the radiation therapy treatments are efficacious and safeA radiotherapy programme generally consists of both external beam and brachytherapy
capabilities and both aspects will be considered together in this section. However where externalbeam and brachytherapy differ this will be pointed out so that those institutions interested inpursuing only one or the other may readily determine the specific requirements.

3.1 HOSPITAL ADMINISTRATORS
Hospital administrators and/or other officials play a key role in determining the initial andongoing support provided to the physician and physicist in setting up and maintaining a radiation
therapy programme. Issues such as equipment procurement, facility design, and staffing levels
involve financial considerations that affect the entire institution. Training may need to be provided
for these individuals so that the process is approached comprehensively and with foresight.
Administrators should be aware that starting or expanding a radiation therapy programme involves
much more than acquiring new equipment. It is essential to allocate adequate funds for staff,
treatment planning and dosimetry equipment, and training. Provision must also be made for ongoingneeds, such as, maintenance, source replacement and an adequate stock of spare parts.

3.2 RADIOTHERAPY STAFFING
3.2.1

Patient Load Assessment

Before initiating a radiotherapy programme, the number of annual patient treatments shallbe estimated. The population within the area from which the institution will draw patients and theannual cancer ratio for that area will yield the approximate number of new cancer patients per year.
Approximately 50-60% of these patients should receive radiation therapy, alone or as an alternative
treatment. An estimate of how many of these patients will be seen at the institution should be madeand compared to the actual patients seen annually. Unusually high cancer rate in the area for specificlocalisation (e.g., lung, oral cavity, nasopharynx, etc.), in which radiotherapy is more frequently
used should be taken into account. Utilization rates must account for possible new uses ofradiotherapy as adjunctive therapy.
For brachytherapy the number of patients seen annually in the institution with malignancies
that are potentially treatable by brachytherapy should be determined. Appropriate categories include
intracavitary and interstitial treatments. The total number of anticipated brachytherapy treatments
can be estimated taking into account the stage of the disease sites amenable to the treatment. Careshould be taken in estimating the number of brachytherapy patients because many of them will
require external beam therapy as well.
3.2.2

Staff

The clinical use of ionizing radiation is a complex process involving highly trained
personnel in a variety of interrelated activities.
TheBSS [1] requires that:a) no patient be administered therapeutic medical exposure unless the exposure is prescribed by a
medical practitioner;b) medical practitioners be assigned the primary task and obligation of ensuring overall patient
protection and safety in the prescription of, and during the delivery of, medical exposure;c) medical and paramedical personnel be available as needed, and either be health professionals or
have appropriate training adequately to discharge assigned tasks in the conduct of thetherapeutic procedure that the medical practitioner prescribes;d) for therapeutic uses of radiation (including teletherapy and brachytherapy), the calibration,
dosimetry and quality assurance be conducted by or under the supervision of a qualified expert
in radiotherapy physics;e) training criteria be specified or be subject to approval, as appropriate, by the Regulatory
Authority in consultation with relevant professional bodies.

The key staff functions in external beam radiation therapy are shown in Table LA and thefunctions involved in radiation therapy are listed in Table I.B and I.C for external beam andbrachytherapy respectively. These tables have been adapted from reference [2], "Radiation
Oncology in Integrated Cancer Management, Report of the Inter-Society Council for Radiation
Oncology, December, 1991." This report is frequently designated "The Blue Book". Minimum
personnel requirements, based on clinical load, are given in Table n, also from reference [2]. Other
recommendations for the staffing in medical physics can be found in a joint report by ESTROEFOMP [3].
It must be emphasized that the most important component of any programme is qualified
personnel. It is vital that all the staff dealing with radiation sources and patients have the necessary
educational background and specialized training. Investment in equipment without concomitantinvestment in training is dangerous.
It is also important that training not only include practical details of individual procedures,
but also how to design treatment approaches which are comprehensive, reproducible, of highquality, and safe. Successful design and implementation of such treatments requires that the hospitaladministration, physicians, physicists, and other support staff work together toward common goals.
The main categories of the staff required along with their responsibilities and training
requirements are listed in Tables I and II.
3.2.2.7 Physician

The physician practicing radiation therapy must first be trained and experienced inoncological practice with post-graduate training in radiation oncology.
The physician will set the overall treatment policy for the radiation therapy programme andshould participate in the design of the facility and the procurement of equipment. For individual
patients the physician is responsible for the patients care, including the details of the treatment andthe patient's follow-up evaluation.
The physician also practicing brachytherapy must first be trained as a radiation oncologist
and experienced in oncological practice. The physician should also have specific training inbrachytherapy at an institution with an established practice, so that the indications for patient
selection, applicator insertion, catheter placement and dose prescription can be learned under thesupervision of experienced mentors. The length of this training will depend on many factors, butwill usually be measured in months. Such a visit should be undertaken whenever a substantially new
form of brachytherapy is introduced into an existing practice, for example when adding high dose
rate brachytherapy.
The physician will set the overall treatment policies for the brachytherapy programme andshould participate in the design of the brachytherapy facility and the procurement of equipment. For
individual patients, the physician is responsible for selecting and inserting the applicator or placing
catheters, prescribing the dose, reviewing and approving the dose calculations, overseeing the dosedelivery, removing the applicator or catheters, and the patient's follow-up evaluation.
3.2.2.2 Medical Physicist

The medical physicist's responsibilities cover four major areas: dosimetry, radiation safety,
quality control, and equipment selection.
In dosimetry the medical physicist helps minimize the probability of patient injury and poor
treatment outcome by assisting in devising, for each patient, an appropriate treatment regimen, andreviewing all patient treatment plans. The medical physicist is responsible for the calibration of theoutput of the treatment machine on a routine basis and assuring that all physical data being used by
the facility are accurate and adequate.
Radiation safety requires the establishment and maintenance of a radiation protection
programme designed to ensure the safety of staff and the public. There is also a need to design andcertify all radiation shielding for the treatment facilities. These duties will be the responsibility ofthe medical physicist, and/or the Radiation Protection Officer who may or may not be the same10

person The administrative structure will vary depending on the nation, the facility and theresources, what matters is that the necessary authority is available
For quality control, the medical physicist will be involved with establishing and running aquality control program for the facility
The medical physicist, in association with the radiation oncologist determines the treatment
equipment needs of the facility Generally this includes medical physicist involvement in preparing
bid specifications and evaluating vendor quotations with respect to both technical requirements andcost effectiveness
The medical physicist should have at least an advanced university degree in a physicalscience or engineering, at least one year of academic and clinical training in radiation oncology
physics, and additional training of at least one month in brachytherapy physics at an establishedcentre, preferably the same centre visited by the physician if these treatments are to be done In thismanner a consistent and comprehensive practice can be developed
For radiation therapy the medical physicist is responsible for ensunng that the treatmentprescribed by the physician is in fact delivered accurately and safely Together with the physician,the medical physicist will design and implement all the elements of the radiation therapy programmethat are described in this report These include, equipment selection, facility design, quality controlof radiation sources and treatment delivery devices, dose calculation and treatment planning,
maintenance, training of ancillary staff, and radiation protection
It must be understood that the practice of radiation therapy absolutely requires that thehospital have a suitable medical physicist on staff It must also be understood that newbrachytherapy responsibilities cannot simply be added to the duties of a medical physicist alreadyresponsible for teletherapy physics It is not sufficient that the physics staff be trained, they mustalso be available in sufficient numbers to carry out all the required duties
The specific number of physics staff required will depend on the number of patients treated,
the type of implants performed, and the complexity of the dose calculation required, and whether atreatment planning computer is to be used However as a minimum each radiotherapy centre shallhave one medical physicist on staff
A high dose rate (HDR) remote afterloading programme requires more technical support
than one using low dose rate (LDR) sources The physician and medical physicist should be present
dunng each treatment, because frequently the degree of complexity of high dose rate planning isgreater than low dose rate brachytherapy The greater potential hazards associated with high activity
sources also requires the presence of a physician and a medical physicist
Large programmes in brachytherapy (300-500 procedures annually) in addition externalbeam therapy will generally require at least a half-time medical physicist dedicated to brachytherapy
and an additional two or three support personnel If customized treatment planning and/or remote
afterloading is practiced, at least one full-time medical physicist devoted to brachytherapy will beneeded with an additional two or three support personnel
The responsibilities of the radiation oncologist and medical physicist are summarized in Appendix
A
3 2 2 3 Ancillary Technical Staff

In addition to the physician and the medical physicist, a radiation therapy programme will
require radiation therapy technologists, dosimetnsts and radiation oncology nurses These
individuals must have a degree, granted by a university or medical school, for academic studies andclinical training for a penod of three or four years
Although the physician and medical physicist may delegate specific duties to these
personnel as appropriate, they will retain the responsibility for providing adequate supervision andtraining For example, computenzed dose calculations may be performed by a "treatment planner
dosimetnst", or preparation of low dose rate sources for patient treatments and maintenance of thesource inventory may be delegated to a "source curator" Such individuals can perform valuable
service as technicians, especially where more highly trained persons are rare, but they should not begiven responsibilities beyond their professional competence11

A clear delimitation of responsibilities is particularly important in the case of dosimetrists or
technologists. In some institutions these professionals substitute medical physicists, and treatment
planning and delivery procedures are made without the supervision of a qualified medical physicist.
Whether this is done for economical or practical reasons, such methodology is not appropriate andmight have detrimental consequences for the patient. For example, the lack of education in
specialized areas of mathematics and physics restricts the understanding of the algorithms used inmodern computerized treatment planning systems; this can easily jeopardize the interpretation of
results produced by limitations of the treatment planning system. The role of the dosimetrist is toassist the medical physicist, not to replace him or her.
3.2.2.4 Social worker and Dietician

An appropriately trained social worker is required to help the patient and family witharrangements regarding transport, employment, care of children, etc. This staff member should bewell informed on radiation procedures to ally initial fears and clarify misconceptions arising from
communications from technical and medical staff. The role of this staff member in ensuring patientcompliance with what are repetitive, unfamiliar procedures, is pivotal to obtaining cure. A dietician
to assist the patients with their nutritional needs during treatment is helpful. Radiation oncology
nurses may be able to perform some of the duties of the social worker and dietician.
3.2.2.5 Maintenance Personnel

If there is a large amount of equipment, such as, several external therapy units andsimulators, block cutting equipment, treatment planning computers, tissue compensation devices,
etc., it might be advisable to ensure the immediate availability of trained engineering maintenancestaff.
If remote afterloading devices are used in the brachytherapy programme, then provisionmust be made for servicing the devices. This may be best accomplished with service agreementswith the manufacturer. Alternatively, staff will need to be trained in the repair and preventative
maintenance to be given to that equipment as well as in the basics of radiation protection. It will beadvisable to have a functional set of manual afterloading devices to allow a continuation of proper
treatment of patients when the remote afterloading equipment is out of service.
3.2.2.6 Radiation protection officer

The radiation protection officer is defined in the BSS [1] as "an individual technicallycompetent in radiation protection matters relevant for a given type of practice who is designated by theregistrant or licensee to oversee the application of the requirements of the Standards". In aradiotherapy facility, the radiation protection officer should design the radiation protection and safety
programme, and oversee its compliance. He/she should prepare the license application, especially thesafety assessment for radiotherapy sources, and as a result, include measures for accident prevention
and mitigation. Depending on the size of the department, the radiation protection officer functions canbe assigned to the medical physicist, but there should be a formal assignment of responsibilities, withclear identification of the line of authority, with respect to radiation protection and safety.

12

TABLE I.A. KEY STAFF FUNCTIONS IN CLINICAL RADIATION THERAPY [2]Key staff

1. Clinical evaluation

Radiation oncologist

2. Therapeutic decision

Radiation oncologist

Supportive role

3. Target volume localization

Tumour volume

Rad. oncologist & physicist

Simulator, technician/dosimetrist

Sensitive critical organs

Radiation oncologist

Patient contour

Physicist

Simulator, technician/dosimetrist
Simulator, technician/dosimetrist

4. Treatment planning
Beam data-computerization
Computation of beams

Physicist
Physicist

Dosimetrist

Shielding blocks, treatment aids,
etc.

Dosimetrist/
Mould Room technician

Radiation oncologist/
physicist

Analysis of alternate plans

Radiation oncologist/physicist

Dosimetrist

Selection of treatment plan

Radiation oncologist/physicist/
dosimetrist

Dose calculation

Dosimetrist

Physicist

Radiation oncologist/
Simulator technician

Dosimetrist/physicist

Radiation oncologist/
dosimetrist/
therapy technician
Radiation oncologist/
therapy technician

Dosimetrist/physicist

5. Simulation/verification of treatmentplan

6. Treatment

First day set-up
Localization films
Daily treatment

Radiation therapy technician

7. Evaluation during treatment

Radiation oncologist/ nurse

8. Follow-up exams

Radiation oncologist/ nurse

Dosimetrist/physicist

Rad. therapy
technician/social
worker/dietician
Data manager/social worker/dietician

13

TABLE I B PROCESS OF RADIATION THERAPY (EXTERNAL BEAM) [2]
1 Clinical evaluation

Initial multidisciplmary evaluation of patient
Decision for radiation therapy
Assessment of pathobiology of tumour
Staging

2 Therapeutic decision-making

Selection of treatment goals-cure/palhation
Choice of modalities of treatment

3 Target volume localization

Definition of tumour extent and potential
routes of spread
Identification of sensitive organs and tissues

4 Treatment planning

Selection of treatment technique
Computation of dose distribution andverification of accuracy
Determination of dose/time/volume
relationship

5 Simulation of treatment

Selection of immobilization devices
Radiographic documentation of treatment
ports
Measurement of patient
Construction of patient contours
Shaping of fields

6 Fabrication of treatment aids

Construction of custom blocks, compensating
filters

7 Treatment

Initial verification of treatment set-up
Verification of accuracy of repeatedtreatments
Continual assessment of equipment
performance
Periodic checks of dosimetry, record keeping

8 Patient evaluation during treatment

Evaluation of tumour response
Assessment of tolerance to treatment

9 Follow-up evaluation

Evaluation of tumour control
Assessment of complications of treatment

14

TABLE I C PROCESS OF RADIATION THERAPY (BRACHYTHERAPY) [2]

1 Clinical evaluation

Initial multidisciplmary evaluation of patient
Decision for radiation therapy
Assessment of pathobioloby of tumour
Staging

2 Therapeutic decision-making

Selection of treatment goals-cure/palhation
Choice of modalities of treatment

3 Target volume localization

Definition of tumour extent and potential
routes of spread
Identification of sensitive organs and tissues

4 Treatment planning

Selection of volume to be treatedSelection of geometry for application
Computation of doses and dose distributions
Estimation of tolerance to procedure
Check off of equipment
Arrangement for surgical suite and anaesthesia

5 Treatment

Examination of anaesthetised patient
Review of initial treatment plan
Implantation

6 Verification of implantation

Orthogonal or stereo radiographs

7 Dosimetry

Calculation from actual implantation
Establishment of time for removal

8 Patient evaluation dunng treatment

Assessment of tolerance
Check of position of implant

9 Removal of implant
10 Follow-up evaluation

Assessment of early and late sequela
Evaluation of tumour control

15

TABLE II MINIMUM PERSONNEL REQUIREMENTS FOR CLINICAL RADIATION THERAPY [2]Category

Staffing

Radiation Oncologist-m-Chief

One per program

Staff Radiation Oncologist

One additional for each 200-250 patientstreated annually No more than 25-30
patients under treatment by a single
physician

Radiation Physicist

One per center for up to 400 patientsannually Additional in ratio of 1 per 400
patients treated annually

Treatment Planning Staff
Dosimetnst or Physics Assistant

One per 300 patients treated annually

Physics Technologist (Mould Room)

One per 600 patients treated annually

Radiation Therapy Technologist
Supervisor

Staff (Treatment)

One per center2 per megavoltage unit up to 25 patientstreated daily per unit, 4 per megavoltage unit

up to 50 patients

Staff (Simulation)

2 for every 500 patients simulated annually

Staff (Brachytherapy)

As needed

Treatment Aid Technologist

As needed, usually one per 300-400 patientstreated annually

Nurse

One per center for up to 300 patients treatedannually and an additional one per 300
patients treated annually

Social Worker

As needed to provide service

DieticianAs needed to provide service

Physical Therapist

As needed to provide service

Maintenance Engineer/Electronics Technician

One per 2 megavoltage units or 1
megavoltage unit and a simulator if
equipment serviced "m-house"164. RADIOTHERAPY FACILITY DESIGN
Facilities for radiotherapy fall into three groups: external beam radiotherapy, low dose-rate(LDR) brachytherapy and high dose-rate (HDR) brachytherapy. The same basic considerations apply
to all: (i) medical and physical well-being of the patient, (ii) protection of the patient, staff, visitors,
and other members of the public from radiation hazards and (iii) geographical and functional
integration of the various activities related to the treatment of the patient.
Space common to all three modalities include office space for physicians and physicists,
laboratories, dark room, registration area and file room.
A physics laboratory with cabinet space to store phantoms, ionization chambers,
electrometers, cables and film should be available. If TLD and film dosimetry are available an area
should be designed for these activities. The darkroom should be conveniently located near theexternal beam therapy and the brachytherapy activities.
An area should be designated for clerical staff to receive bookings and register new patients,
sign in patients under treatment and retrieve files for follow-up patients. A file storage area should
be provided.
It is preferable to provide air conditioning for the facility, however as a minimum air
conditioning should be provided for the treatment planning room and treatment control areas where
computers are located.

4.1 EXTERNAL BEAM THERAPYAn external beam facility requires examination rooms, simulator room, treatment planningroom, mould room, treatment room, and waiting areas. Design of the simulator room, treatment
planning room and treatment room should be performed in consultation with the manufacturer of theequipment. Power, air conditioning and emergency system requirements must be considered.

4.1.1 Examination Rooms
Examination rooms should be in close proximity to the treatment room. The examination
rooms should include a standard and gynaecological examination table, a head and neckexamination chair, appropriate examination instruments and medical supplies.
4.1.2 Simulator Room

The shielding of the simulator room shall be designed according to the recommendations of
NCRP Report 491 [5] paying due regard to requirements of the BSS [1] and the Regulatory
Authority. The room should be large enough to accommodate the simulator allowing the full rangeof motion of the treatment table. A means of securely mounting patient positioning lasers to the wallat points appropriate to project lines through the isocenter should be included in the plans. Meansfor dimming the room lights should be considered in the design of the room. Adequate space shouldbe planned for cabinetry to store treatment devices and daily quality assurance equipment. If theimmobilization devices are to be fabricated in the simulator room, cabinet space to store supplies fortheir fabrication will be required. A sink should be provided in this room.
A viewing window should be provided for the control room. Light boxes in the control roomand simulator room are useful.

4.13 Treatment Planning Room
The treatment planning room should be located in proximity to the simulator room although
the two areas do not have to be adjacent. The room should be large enough to house the treatment
planning computer with its video monitor, a printer and plotter, a digitizer tablet, and other required1
Al the time of preparation of this document, NCRP Report 49 was in the process of revision All references to NCRP 49 should be to
the revised document when it appears

17

computer equipment. Space will also be required for supplies of paper and pens or ink for the printerand plotter. An area designed to accommodate an L-shaped arrangement of the digitizer tablet andvideo monitor is frequently more desirable than a linear arrangement with the two devices side-byside. It is also desirable to provide space for light boxes and a high intensity light for viewing CT
scans and plane X-ray films.
4.1.4 Mould RoomSpace should be planned for a mould room to fabricate custom designed blocks andcompensators. Room for a block cutter and counter top workspace for pouring and mounting theblocks is required. Storage space for supplies of Styrofoam, trays and shielding material for custom
blocking is necessary. Adequate ventilation should be provided if shielding materials are melted inthis area. If immobilization devices are fabricated in the mould room space for a patient couch will
be required.

4.1.5 Treatment Room
The treatment room shielding should be designed in accordance with the recommendationsof NCRP Report 49 [5] paying due regard to requirements of the BSS [1] and the Regulatory
Authority. A sign should be posted on the door warning of the radiation hazard, in accordance with
Regulatory Authority. The room should be large enough to accommodate the treatment machineallowing the full range of motion of the treatment table. A door interlock or other suitable means toprevent unauthorized access shall be provided and a power-fail-safe area radiation monitor should
be visible on entering the room. Means for dimming the room lights should be considered in thedesign of the room. Adequate space should be planned for cabinetry to store treatment devices,
immobilization devices, blocks and daily quality assurance equipment. A means of securely
mounting patient positioning lasers to the wall at points appropriate to project lines through theisocenter should be included in the plans.
Space for a console immediately outside the treatment area overlooking the treatment room
door shall be planned. This console area should be large enough to accommodate not only thecontrol console for the unit but a work space for the treatment technologist and space for anintercom and closed circuit television system (if there is no viewing window). The console area
should also accommodate any computer equipment associated with the treatment machine. This may
include an information management system, electronic imaging, or treatment time calculation
systems.
4.1.6 Waiting Areas

It is desirable to have separate waiting areas for patients attending clinical visits and thoseawaiting treatment. The clinical waiting area should have space for approximately eight patients foreach physician.
The treatment waiting area should be adjacent to the treatment room with space for seatingof about twelve people for each machine. There should also be an area provided for stretcher
patients. This area should be adjacent to the treatment area but preferably separated from theambulatory patients. The area should be large enough to accommodate three stretchers.
4.2 LOW DOSE RATE (LDR) BRACHYTHERAPYFor radiation protection purposes, LDR brachytherapy should employ either manual or
remote afterloading equipment except for some situations (permanent implants, eye implants).
Either modality will require a source storage and preparation room, operating room, treatment
planning room and patient room. These facilities should not be too widely separated in order toreduce distances over which the patient and sources have to be transported. The relative proximityof these facilities can significantly influence procedure flow and efficiency. Facility design shouldincorporate features to avoid elevator transport of patients containing radioactive sources.

18

Sterilization facilities for applicators will also be required. The sterilization process should beappropriate to prevent damage of the applicators.
4.2.1 Source storage and preparation room

This room should be designed in accordance with the recommendations of NCRP Report 49[5] paying due regards to requirements of the BSS [1] and the Regulatory Authority, and be
provided with a locked door to control access to the radioactive material. A sign should be posted on
the door warning of the radiation hazard, in accordance with Regulatory Authority. It should containshielded storage for all sources and have facilities for receiving, preparing, calibrating and returningsources. An area radiation monitor should be visible on entering the room and while preparing thesources. Space for a workbench should be provided. A cabinet for the necessary instruments,
equipment, treatment aids, and the required documents should also be available. Space for source
transportation trolleys should be provided. It may also be necessary to provide storage to allow
decay of sources to safe levels.

4.2.2 Operating room
If anaesthesia is required for placement of applicators or catheters to contain the radiation
sources, an operating room facility and recovery room are required. A X-ray unit, preferably withfluoroscopic capabilities, is desirable in the operating room because it enables the position of theapplicator or catheters to be checked, and if necessary repositioned, before the patient leaves theoperating suite. In addition localization X-rays (orthogonal or stereo shift X-rays) required for dose
calculation purposes can be taken with this unit. If no X-ray unit is in the operating room thesefunctions must be available elsewhere.
4.2.3 Treatment Planning Room

The treatment planning room should be located in proximity to the operating room although
the two areas do not have to be adjacent. Other design elements of the treatment planning room may
be found in Section 4.1.3.
4.2.4 Patient room

It is preferable to house each LDR brachytherapy patient in a separate room. The roomshould be shielded according to recommendations in NCRP Report 49 [5] paying due regards torequirements of BSS [1] and Regulatory Authority. A sign should be posted on the door warning of
the radiation hazard in accordance with Regulatory Authority. If several rooms are required theyshould be adjacent to each other. The patient should be attended by nurses with special training incare of radiation therapy patients. Storage for a bed side shield and emergency source container
should also be provided.

4.2.5 Additional Requirements for LDR Remote-Afterloading
The major benefit of remote afterloading is reduction of exposure to nursing staff, otherpersonnel, and visitors. Other shielding requirements for uncontrolled areas surrounding thetreatment area are unchanged.
Additional requirements for remote afterloading include:a) Additional floor space and required utilities (dedicated compressed air and power sources).
b) Door interlock or other suitable means to prevent unauthorized access to the patient's room.
c) A power-fail-safe area radiation monitor in the patient room.

194.3 HIGH DOSE RATE (HDR) BRACHYTHERAPY
An increased demand to the Agency from developing Member States on HDR brachytherapy
equipment is expected in the near future. The reason is that some types of cancer, suitable to betreated with brachytherapy, are very frequent in developing countries and HDR brachytherapy may
be the only practical solution to successfully treat a large number of patients. On the other hand, if
HDR is introduced without adequate expertise in conventional brachytherapy, training andorganizational arrangements, it may lead to an unacceptable risk. In order to reach balanced
decisions for the Safety, Clinical-Radiotherapy and Physical-Dosimetry aspects of the projects, asystematic approach has been adopted by the Agency where upon analysis of the benefit/risk ratio, acase by case study will consider if the country satisfies the following criteria:a) Demonstrable volume of patient workload justifying the need for the HDR brachytherapy
equipment.
b) Long departmental experience with other forms of brachytherapy, including the ability to planand calculate brachytherapy treatments and maintain appropriate quality assurance and safety
procedures.
c) At least three radiation oncologists and one medical physicist whom can satisfy requirement (b).
d) All practitioners (radiation oncologists and medical physicists) must receive training on thespecific model of equipment supplied by the Agency, including the Treatment Planning Systemand safety/emergency procedures for the particular model of equipment.
For reasons of safety and quality, all equipment delivered by the Agency will beaccompanied by a document issued by the Agency asking the recipient that all repairs may only beundertaken by factory authorized (namely, trained and certified) personnel.
4.3.1 Options
If the feasibility of sharing a shielded treatment room between an HDR unit and anothercurrently-used treatment machine is considered, it should be carefully evaluated. To avoid
scheduling problems considerations should include the anticipated number of HDR procedures aswell as the number of external beam treatments. This report recommends against this strategy inmost instances.
An HDR brachytherapy facility requires (i) an operating room or outpatient surgery room,(ii) a radiographic imaging system, (iii) treatment room, and (iv) treatment planning area. The
relative proximity of these facilities can significantly influence procedure flow and efficiency. Three
major options for the first three of these items, in order of increasing capitalcost, are:a) Treatment room for the HDR unit, and shared use of existing operating or procedure rooms andimaging systems, such as a simulator. The patient transport (between operating room, imaging
room and treatment room) reduces efficiency and hinders immobilization of the applicatorsystem.
b) A treatment room for both applicator insertion and treatment with imaging performed
elsewhere. Conditions for anaesthesia and sterility might require a significant investment. In
addition other medical staff, e.g., gynaecologic oncologist and anaesthesiologist, should becommitted to supplying medical services outside their usual venue. As above, the patienttransport (between operating room, imaging room and treatment room) reduces efficiency andhinders immobilization of the applicator systemc) Integrated brachytherapy suite. This option adds a dedicated imaging system in the treatment
room to approach (b). This option is the most efficient requiring no transport of the patient
between the different steps.

4.3.2 Operating RoomFor design elements of the operating room, please refer to Section 4.2.2.

20

4.3.3 Outpatient Surgery Room

If anaesthesia is not required for placement of applicators or catheters to contain theradiation sources, an outpatient surgery room may be used. A X-ray unit, preferably withfluoroscopic capabilities, in this room is desirable because it enables the position of the applicator orcatheters to be checked, and if necessary repositioned, before the patient leaves this room. In
addition, localization X-rays (orthogonal or stereo shift X-rays) required for dose calculation
purposes can be taken with this unit. If no X-ray unit is in this room these functions must be
available elsewhere.

4.3.4

Treatment Planning Room
Design elements of the Treatment Planning Room may be found in Section 4.1.3.

4.3.5

Treatment RoomHDR brachytherapy must be performed in a properly shielded and secured area. The roomshould be shielded according to recommendations in NCRP Report 49 [5] paying due regard torequirements of the BSS [1] and the Regulatory Authority. A door interlock or other suitable means
to prevent unauthorized access shall be provided and a power-fail-safe area radiation monitor should
be visible on entering the room. A sign should be posted on the door warning of the radiation
hazard, in accordance with Regulatory Authority. Space for a console immediately outside thetreatment area overlooking the treatment room door shall be planned. This console area should belarge enough to accommodate not only the control console for the unit but a work space for theradiographer and space for an intercom and closed circuit television system (if there is no viewing
window). The console area should also accommodate any computer equipment associated with thetreatment machine. It is also desirable to provide space for light boxes for viewing CT scans andplane X-ray films.
In contrast to external beam treatment units, the location of the HDR source is notmechanically fixed to a single point in the room and is uncollimated; every wall must serve as a
primary barrier. For these reasons in an external beam treatment room used for HDR, existing
barriers designed to protect against scattered and leakage radiation may not be adequate.

5. EQUIPMENT

5.1 INTRODUCTION
Before any equipment is selected, the clinical goal of radiation therapy should be clearly
defined to ensure that the specifications of the equipment under consideration satisfy the clinicalneeds. The choice of the equipment that will meet most of the clinical needs in the local situation
should be made jointly by the responsible radiation oncologist and the medical physicist. The choiceof the kind of treatment delivery system will affect the other equipment needs.
The BSS (BSS.H.13) [1] requires that equipment consisting of radiation generators andthose containing sealed sources needed for medical exposures whether imported or manufactured in
the country where it is used:a) conform to applicable standards of the International Electrotechnical Commission (EC) and theInternational Standards Organization (ISO) or the equivalent standardsb) performance specifications and operating and maintenance instructions, including protection
and safety instructions, be provided in a major world language understandable to the users andin compliance with the relevant EC or ISO standards with regard to accompanying documents,
and that this information be translated into local language when appropriate. When equipment
manufactured in one country is to be exported into another country with the Agency's
assistance, documentary evidence (i.e., a copy) of the National Standards has to be provided

21

with the quotation (bid) to assess whether the national standards are actually equivalent to EEC
and ISO.

5.2 EQUIPMENT FOR EXTERNAL BEAM RADIOTHERAPY
The equipment needs for external beam radiation therapy fall into five main categories:
simulation, treatment planning, treatment delivery, quality assurance and radiation safety.
5.2.1 Simulator
The simulator should meet the specifications enumerated in Appendix B, Specifications fora Treatment Simulator. Additional information can be found in the report published by the British
Institute of Radiology [6].
5.2.2 Treatment Planning Equipment

The treatment planning system should meet the specifications enumerated in Appendix C
and must meet the needs of the external beam radiotherapy treatments as determined by the clinicalgoals of the department.
A programmable calculator or a personal computer may be used to calculate treatment
times, based on either the treatment plan or a central axis depth. If a personal computer is available
it should include application programs of a spreadsheet and a word processor. The spreadsheet may
be used to develop programs to calculate treatment time, analyze machine data and verify
calculations of the treatment planning computer. The word processor may be used for writing
reports including results of acceptance testing, commissioning measurements, calibrations andquality assurance tests, and patient in-vivo measurements. The word processor is also useful for
writing dosimetry and treatment policies and procedures required by the quality assurance program.
A contouring device should be available for contouring the patient for entry to the treatment
planning computer. The contour device could be Plaster of Paris strips, a lead solder wire, or otherdevice expressly designed for patient contouring.
5.2.3

Teletherapy Unit

The ^Co teletherapy unit should meet the specifications enumerated in Appendix D. This
report does not consider provisions by the Agency of a clinical accelerator.
5.2.4

Quality Assurance Equipment

lonometric and film dosimetry systems should be available for quality assurance(commissioning, calibration and quality control) of the teletherapy unit. These systems should meetthe specifications enumerated in Appendix E. The ionometric systems should also conform to thespecifications in the IAEA TRS-277 [7] or TRS-381 [8] and should have been calibrated at astandards laboratory within the last two years. Supplementary equipment listed in Appendix Eshould also be available.

5.2.5 Radiation Safety Equipment
This instrumentation should include a power-fail-safe radiation area monitor inside the ^Cotreatment room, a Geiger-Mueller survey meter and a large volume ionization chamber.

5.3 EQUIPMENT FOR BRACHYTHERAPY
The equipment needs for brachytherapy fall into five main categories: imaging, treatment
planning, treatment delivery (including afterloading equipment, sources, source storage andtransportation, and applicators), quality assurance and radiation safety and source handling.

22

The following distinctions in brachytherapy modalities are made: manually afterloaded low
dose rate brachytherapy, remote afterloaded low dose rate brachytherapy and remote afterloadedhigh dose rate brachytherapy.
5.3.1 Imaging Equipment
Although it is possible to state the delivered tumour dose for some fixed brachytherapy
applicators, individual treatment planning is desirable to assess the dose to critical normal structuresin all cases. For treatment planning the applicator and source geometry need to be reconstructed.
The most common method is reconstruction by means of a pair of orthogonal radiographs. A X-ray
unit with fluoroscopic capabilities in the operating room is desirable because it enables the positionof the applicator or catheters to be checked, and if necessary repositioned, before the patient leaves
the operating suite. In addition localization X-rays (orthogonal or stereo shift X-rays) required for
dose calculation purposes can be taken with this unit. If imaging equipment is not available in theoperating room, use of an isocentric simulator is preferred. If a simulator is not available, nonisocentric (diagnostic) X-ray equipment can be used, but a fixed geometric structure containing
fiducial markers (sometimes designated as a "localization box") is often needed to derive or verify
the parameters needed for reconstruction (magnification factors and radiography angles).
In order to visualize the positions of sources during treatment, radio-opaque dummy sources
should be inserted in the applicator or in the catheters while taking the localization X-rays.
5.3.2 Equipment for Treatment Planning
For the selection of a treatment planning system it is essential to verify that the system cansatisfy the needs of the brachytherapy treatment as set by the clinical goal. Treatment planningsystems should meet the recommendations in Appendix C and must meet the needs of thebrachytherapy treatments as determined by the clinical goals of the department.
A programmable calculator or a personal computer may be used to calculate treatment times fromthe prescription based on the treatment plan. If a personal computer is available it should include
application programs of a spreadsheet and a word processor. The spreadsheet may be used todevelop programs to maintain a database for the source inventory, decay source activities
automatically, calculate treatment times, and verify calculations of the treatment planning computer.
The word processor may be used for writing reports including results of acceptance testing,commissioning measurements, calibrations and quality assurance tests, and patient in-vivo
measurements. The word processor is also useful for writing dosimetry and treatment policies andprocedures required by the quality assurance program.
5.33 Treatment Delivery Equipment
The decision whether to use a remote afterloading system instead of manual afterloading for
LDR brachytherapy should be based on a balance of advantages of a remote afterloader (mainly areduction of radiation exposure for hospital personnel) against the disadvantages (cost of purchasing
and maintenance, increased complexity and possible lack of technical support).
Similarly, the choice between HDR and LDR brachytherapy should be based on a carefulconsideration of the local clinical situation. This balance will depend strongly both on the local
clinical goals of brachytherapy and on the local factors like patient load, available staff andresources, see Section 4.3. Further considerations on these two treatment modalities are given in
Appendix F.
Both LDR and HDR sources should be accompanied by a source certificate, specifying:a) the source strength, preferably in terms of Reference Air Kerma Rate (RAKR), i.e. the air
kerma rate to air, in air, at a reference distance of 1 m, corrected for air attenuation andscattering (this quantity is expressed in uGy h"' at 1 m, c.f. ICRU Report 38).
b) the quality control tests applied to the source.
The choice of applicators depends entirely on the treatment protocol and must be compatible
with the clinical preference of the physician.

23

If manually afterloaded LDR sources are used, a source storage container should be locatedin the source preparation room. The shielding requirements should meet the criterion specified in
BSS [1]. A transport container is needed to transport prepared sources to the patient treatment area.
5.5.3.1 Low Dose Rate (LDR) Afterloading

LDR brachytherapy may be performed either manually or with a remote afterloading unit.
The low dose rate remote afterloading units should meet the specifications enumerated in Appendix
G.
Currently, the most common isotopes for LDR brachytherapy are 137Cs, 125I, and I92lr. 137Cs
sources can be obtained as line sources (needles or thin tubes for interstitial applications, spheroidalshaped pellets or tubes for intracavitary applications). 125I is available as seeds. I92lr LDR sources
can be obtained in many different forms, e.g. as flexible wires in coils or sealed in plastic catheters,
as ribbons (strands of small cylindrical seeds, usually sealed in plastic catheters) or in a form that
may be used directly for interstitial implants (e.g. "hairpins").
In the decision as to the type of sources to use when starting a brachytherapy programme,
the problem of how to dispose of sources after their useful life must be solved. Except for 137Cs allbrachytherapy sources have a limited period of use, because decay of the sources leads to longer
treatment times, and for older sources there is an increased risk of damage to the source integrity.
5.3.3.2 High Dose Rate (HDR) Remote Afterloading Units

The high dose rate remote afterloading units should meet the specifications enumerated inAppendix G.
For HDR brachytherapy, I92lr sources are used because the sources can be fabricated as thin,
flexible wires and 192Ir has a high specific activity permitting the realization of high activity sources.
However I92lr has a rather short half time (approximately 74 days) that necessitates frequent source
exchange. The 192Ir source in the HDR afterloader should be exchanged by the manufacturer every
three months.
Sources of '37Cs and ^Co are also available for HDR treatments, although their use is not as
common as in the case of 192Ir.
5.3.4 Quality Assurance Equipment

Equipment for dosimetry and quality assurance (calibration and quality control) should
conform to the recommendations enumerated in Appendix G. Preferably the calibration of theionometric system should be performed at a standards laboratory every second year. If this is notpossible it is recommended that a calibrated brachytherapy source similar in construction to sources
used clinically be acquired to calibrate the ionometric system. For verification of high dose rate
source calibrations it is desirable to have a specially designed well-type ionization chamber with acalibration traceable to a standards laboratory.
In order to verify the uniformity of a line source, film autoradiography is frequently used.
An alternative possibility is using a detector with a narrow collimator aperture, over which the line
source is moved to obtain a relative measurement of the linear source strength. If autoradiography isused a densitometer should be available in the department. To ensure reproducible placement of line
sources parallel to the film, an autoradiography jig can be used.
If a HDR afterloader with a single stepping source is used, it is mandatory to verify theaccuracy of the source cable drive mechanism to position the source. The afterloading machine
should be equipped with a device ("source position check ruler") in which the source cable pushes asmall marker out to a position measurable along a ruler.
For high dose rate remote afterloaders, special autoradiography phantoms have beendeveloped to visualize the actual source positions together with fiducial markers caused byscattering at the edges of a number of lead sheets. The use of such a phantom for quality assurance
has the advantage that the actual source positions are verified rather than the positions of radioopaque dummy sources on a radiograph.

245.3.5Equipment for Radiation Safety and Source Handling

Equipment for radiation safety and source handling should be available according to therecommendations enumerated in Appendix G.
Special considerations for LDR source handling include:a) A workbench in the source preparation room equipped with an L-block (workbench shielding)having a lead glass viewing window.
b) Magnifying glass and illumination for visual inspection of sources.
c) Source manipulators, such as forceps.
d) If iridium wires are used, a dedicated source preparation station is needed to cut wires to therequired length and seal them in plastic catheters.
e) If iridium wires/seeds are used in a variety of different lengths, several storage container are
needed to allow easy and reliable retrieval of the different line sources in stock.
f) For protection of personnel during patient source loading and unloading and during care of thepatient, movable lead shields are required.
g) Finger dosimeters.
Special considerations for HDR source handling in case of a failure of the afterloading unit include:a) A storage container present in the treatment room to serve as an emergency source container incase of failure of the afterloader in retracting the source.
b) A remote manipulator.
c) A rod mounted GM detector for source localization.

6. QUALITY ASSURANCE OF THE RADIOTHERAPY PROGRAMMEAND PATIENT RADIATION PROTECTION
Quality Assurance in radiotherapy consists of procedures that ensure a consistent and safe
fulfilment of the dose prescription to the target volume with minimal dose to normal tissues andminimal exposure to personnel and the public. It involves both clinical and physics aspects. The
main areas will include clinical policies, treatment planning and delivery, a quality control
programme for machine and equipment performance, maintenance programmes and investigative
procedures for accidental medical exposures. The establishment of such a comprehensive quality
assurance programme shall be in accordance with the BSS. [1] and the guidelines given by WHO[9]. An important aspect of any quality assurance program is continuous quality improvement (CQI),
a commitment of the staff to continuously strive to improve treatment based on new information
learned from their quality assurance program and new techniques developed by the radiation therapy
community at large. Continuing medical and medical physics education are essential aspects of CQI.
Journal clubs, monthly departmental meetings to review treatment outcomes and unexpectedmorbidity, visiting lecturers and attendance at professional meetings are strongly encouraged. An
effective quality assurance program demands a strong commitment from the departmental andinstitutional leadership to provide the necessary resources of time, personnel and capital.
The objective of patient safety as defined in the BSS (n 18a), i.e., to ensure that exposure of
normal tissue during radiotherapy be kept as low as reasonably achievable consistent with delivering
the required dose to the planning target volume, is part of the objective of the treatment itself. The
measures to ensure quality of a radiotherapy treatment inherently provide for patient safety and forthe avoidance of accidental exposure. The patient safety is integrated, therefore, with the quality
assurance of the radiotherapy treatments.
A documented quality assurance programme consists of policy statements, written
management procedures, work instructions, data sets and reference documents, prescription sheets,
request forms, records, etc. Policy statements commit all staff within an organization to follow aparticular policy and are made by persons in senior managerial positions. A management proceduredefines how a particular objective is achieved, and should be written by the person with overall
responsibility for that procedure. For ease of up-dating, and for ease of document control and ofaudit, each written procedure should have limited aims and a limited scope. In addition to stating theaims and scope, each procedure should (i) list key responsibilities with a statement of who has

25overall responsibility for that procedure, (11) list any documentation that may be required to enable
that procedure to be earned out (e g work instructions, data sets, etc ), (in) list the documentationthat is generated as part of that procedure, and (iv) contain an outline method indicating who is
responsible for different aspects of the work described, and how they interact with, and pass
responsibility to, technical and professional staff from other sections (e g medical staff, physicists,
technicians, nurses, etc )It is essential that the management of the installation makes the appropnate arrangements toinsure that the radiotherapy equipment is available to the medical physicists to carry out the Quality
Control measurements (see Appendix I)

6 1 CLINICAL ASPECTS OF THE QUALITY ASSURANCE PROGRAMME
Prior to embarking on a radiotherapy programme of treatments, the chief radiation
oncologist at the centre concerned should formulate the centre's policies in respect of the items
discussed below These items constitute the basis of the clinical aspects of quality assurance

6.1.1 Treatment Policies
Treatment policies serve to prevent a mismatch of treatment philosophies, and to allow any
non-standard practice to be questioned Once the treatment policies have been defined by theappropnate physician for the full range of radiotherapy (external and brachytherapy) techniques
proposed, they should be implemented in conjunction with the medical physicist The prescribed
doses (or ranges of prescribed doses) and the overall treatment regimens should be defined for
different disease sites, tumour stage, and presentations

6.1.2 Clinical Case Conferences for Review of Proposed/Recent Patient Treatments
It is desirable that regular case conferences are held involving all technical and professional
personnel who may have a part to play in ensuring the quality of the treatment The purpose is to
mitigate against mistakes arising from incomplete understanding of the clinical problems and of theaims of treatment Such meetings also provide a forum for continuing resource assessment Where
possible, times, locations, and a list of expected attendees should form part of the policy statement
6.1.3 Clinical follow-up and Statistical Review

Every effort should be made to assess the outcome of treatments and to compare local
results with those published by established practitioners who are following similar treatment
policies and regimens The purpose is to allow controlled and safe introduction of improvements totreatment regimes If local results are significantly worse then there should be a mechanism toreview, and possibly change, local procedures Statistical methods must follow accepted practiceand where possible advice should be sought from a professional statistician The methods of datacollection and storage, and the mechanisms for follow-up, review, and technique revision should be
documented

6 2 PHYSICAL ASPECTS OF THE QUALITY CONTROL PROGRAMME
Once the equipment has been shown to meet its specifications and accepted from the
manufacturer (see Section 2 2 2 1), it will then be commissioned for clinical use The results of thecommissioning tests serve as reference for subsequent checks All measurements should be recorded
in a logbook As this logbook serves as the principal archival source for all acceptance tests andcommissioning measurements, the logbook should have sequentially numbered pages of high quality
paper and these pages should be sewn in, not glued in. Logbooks with inferior paper can quickly
degrade The glue used for attaching the pages in logbooks also deteriorates with time and use andpages can fall out and be lost26

The acceptance tests demonstrate the equipment meets or exceeds the bid specifications.
Frequently acceptance tests follow a protocol supplied by the manufacturer, but the purchaser may
develop his/her own protocol. In either case the acceptance test protocol must be part of thepurchase order for the equipment, so that both sides agree to what constitutes acceptance of theequipment and both sides are aware of the expectations of other party.
Acceptance tests protocols specify what tests will be performed, what equipment is used to performthese tests and what the results of these tests should be. They constitute a legal document in which
the medical physicist confirms that the equipment met the specifications of the bid.
At the completion of acceptance tests, commissioning measurements begin. During commissioning
measurements the physicist will measure all the data required to place the unit into clinical service.
The physicist must assure that all data needed to perform any anticipated clinical procedure isacquired at this time. The data should be acquired in the format required for entry into the treatment
planning computer. All data should be compiled into a loose leaf notebook for archival purposes.
The pages of the notebook should be dated and signed by the physicist. This notebook format also
serves well for maintaining a set of data to perform hand calculation of treatment times.
Immediately at the conclusion of the commissioning measurements, quality control tests
should be established. A good equipment quality control programme should specify:a) the different tests to be performed,b) the equipment, including serial numbers, used to perform the tests,c) the geometry of the tests,d) the frequency of the tests,e) who performs the tests,f) the expected results,g) tolerance values, andh) actions required when the tolerance levels are exceeded.
It must be emphasised that checks should be performed only by qualified and experienced
persons, such as the medical physicist, who can delegate the work to persons he/she has trained.
Regardless of who performs the tests the physicist remains the responsible party for assuring thecorrect performance of the equipment.
The physicist must also verify that the data in the treatment planning computer, any
computer used to calculate treatment times, and in the loose leaf notebooks are correct andconsistent.
The details of a quality control and safety programme are given in Appendix I, which ismainly based on the reference "Comprehensive QA for radiation oncology. Report of AAPM
Radiation Therapy Committee Task Group 40," by Kutcher et al, Med. Phys. 21: 581-618, 1994 [4].
Further information can be found in the ESTRO publication "Quality assurance in radiotherapy,"
Radiother. Oncol.,35, 61-73, 1995 [10].
6.3 RADIOTHERAPY PLANNING AND DELIVERYThis section discusses procedures which occur between the consultation, or examination, at
which the decision is taken to treat a patient by radiotherapy and the completion of that treatment.

63.1

Initial Evaluation

The overall responsibility for procedures under this heading will lie with the radiation
oncologist. The aim will be to ensure that appropriate clinical management decisions are taken forthe particular site, stage, extent, etc. of the disease, and that an unambiguous prescription is written.
Methods for examination procedures should state the nature of the examinations required, givereference to staging protocols, treatment protocols, etc. and state where the results of theexaminations, and any consequent clinical management decisions, are recorded.
A very critical step is the initial evaluation of the patient and the extent and nature of thetumour. This includes a complete physical examination of the patient and review of all diagnostic
studies such as radiographs, radionuclide scans, ultrasound, laboratory data, pathology slides, andreports. It is important for the radiation oncologist to be aware of the biological and pathological27

characteristics of the tumour, as well as clinical manifestations, so that probable sub-clinicalextensions of the tumour can be included in the treated volume The full extent of the lesions should
be determined and staged accordingly
6.3.2

Therapeutic Decision

The therapeutic decision includes a determination of the goal of therapy (cure or palliation),
evaluation of the alternative therapeutic approaches and a choice of the therapeutic modalities to be
used in the patient
6.33 External Beam Radiotherapy
6331 Tumour Location

Once it is determined that the radiation therapy is to be administered, it is critical to assess theextent and location of the tumour volume and the surrounding normal structures This can beaccomplished by physical examination and appropnate imaging modalities, e g, radiographic orradionuclide studies, computed tomography, ultrasound, or magnetic resonance imaging The
clinical target volume can then be determined
6332 Treatment Planning

Treatment planning involves several steps, including localization and/or simulation,
procedures earned out using a special radiographic unit (simulator) that can reproduce the geometricconditions of the patient on the radiation therapy machines The tumour and normal structures must
be localized in a geometry identical to that used during the delivery of the treatment, the planningtarget volume is determined at this time Depending on the complexity of the treatment, portals canbe designed directly in the simulator or their size, orientation, weight, etc may be determined withthe aid of a treatment planning computer system
The physician prescnbes the dose to the tumour and any organs at nsk and the physicist
carries out calculation of doses, computation of beams, and isodose distributions The physician, in
consultation with the physicist, will analyze the alternative plans of therapy and select the best forthe patient Dose calculations can also be performed by properly trained staff (technicians,
radiographers, or dosimetnsts) under the supervision of the physicist
The need for immobilization and repositioning devices, shielding blocks, masks, andcompensating filters must be assessed dunng the treatment planning procedure If necessary, theseaids will be designed by the physician and constructed by the treatment planning teamAt the completion of the treatment planning process, it may be advisable to use thesimulator again to simulate the patient with the final treatment portals, including the immobilization
devices and shielding blocks in position prior to the initial treatment
With the emergence of 3D conformal therapy and intensity modulated radiation therapy
employing non-coplanar beams, the treatment planning process may increasingly include the use of
a computed tomography(CT) scanner as a "virtual simulator " An important aspect in the use of a
CT scanner for treatment planning is that the patient support assembly(PSA) of the scanner must beflat to match the treatment machine PSA rather than the more usual concave PSA of CT scanners
An insert with a flat top and curved bottom that fits the curvature of the CT support assembly is aneasy method to achieve this goal
6333 Treatment Delivery

The treatment is earned out by the radiotherapy technician under the supervision of thephysician and/or the physicist Regardless of the degree of participation by the physicist thephysician remains the sole individual responsible for all clinical aspects of the treatment The
participation of the three professionals is always convenient for the first treatment, especially with28

complex beam set-ups. Periodically, portal films and verification of doses recorded on the charts are
performed.
The physician will evaluate the patient at least weekly during the course of therapy to assesstumour response and tolerance of the patient to the treatment. Examinations may be carried out more
often, particularly when there is need for supportive care, such as to improve the nutrition of thepatient, prescribe medication to decrease symptoms, treat current diseases, and provide instructions
and medication to treat the side effects of therapy.
The radiation oncologist will work closely and communicate with the referring physician toco-ordinate the overall care of the patient and to integrate the radiation therapy with othertherapeutic modalities.
6.3.3.4 Periodic Evaluation and follow-up

Periodic follow-up examinations after treatment are critical, not only to evaluate the generalcondition of the patient and tumour response but also to detect recurrences early, should they
happen, and to observe the effects of irradiation on the normal tissues.
Table I.B in Section 3 outlines the above steps for external beam radiotherapy.
6.3.4 Brachytherapy
6.3.4.1 Examination and Prescription
For some brachytherapy treatment techniques the prescriptions will be written prior toinsertion of the sources; for others it may be more appropriate to write the prescription after theinsertion of sources. In either case the prescription should be written on a prescription sheet which
has been designed for that purpose, and signed by the responsible clinician. There should be aprocedure whereby the prescription is independently checked (e.g. by a different calculation
method) for compatibility with the departmental policy and a record should be made of that check.

6.3.4.2 Insertion of the Applicator or Catheter and Source Preparation
The overall responsibility for the insertion procedures themselves will again lie with theradiation oncologist. Procedures for preparation of sources and the calibration of instruments should
be carefully defined. Critical procedures (e.g. source preparation) should incorporate an independent
check and authorization signature. Following a manual application there may be unused sources thatmust be returned to an appropriate storage location. There should be a procedure to ensure this isachieved safely and efficiently, independently checked, and that the source locations log isappropriately up-dated.
The overall responsibility for the imaging procedure lies with the radiation oncologist.
Generally at the time of the brachytherapy procedure, dummy sources (i.e. non radioactive) are
inserted into the applicator or catheters. Radiographs of the implant are then obtained for two
purposes: i) to see that the position and arrangement of the implant is correct, and ii) to determine
the location of the sources (shown by the dummy sources) in order to calculate the dose distribution
and to select the appropriate activity of the sources required to deliver the dose. At this time theclinician can make an immediate decision on whether or not to continue with the treatment or tomodify the application. As described in Section 5, orthogonal or stereo shifted radiographs might berequired.

6.3.4.3 Treatment PlanningThe overall responsibility for calculation of dose and dose distribution to determine theduration of the implant will lie with the medical physicist. The planning procedures must becompatible with the chosen clinical practice, and must include a method of independent verification.
These procedures will define how the specific treatment parameters are passed to the person

29controlling treatment delivery The final treatment parameters must be approved by the prescnbingradiation oncologist
6344 Treatment Delivery

The overall responsibility for treatment delivery and particularly for the termination oftreatment will lie with the radiation oncologist The mam procedures will cover (i) treatment start-up(for afterloading treatments), (11) patient and/or applicator monitoring to ensure the continuing
integrity of the application, (in) emergency procedures with clearly stated action criteria, (iv)procedures for unplanned activity or treatment interruption (e g for additional check radiography),and (v) completion procedures including removal of sources and applicators and, where appropnate,
the safe return of sources to appropnate storage locations Further technical procedures will coverchecking of the returned sources and the up-dating of source location records
6345 Periodic Evaluation and Follow-up

Penodic follow-up examination after treatment is critical, not only to evaluate the generalcondition of the patient and tumour response but also to detect recurrences early, should they
happen, and to observe the effects of irradiation on the normal tissues
Table I C in Section 3 outlines the procedures listed above

64 MAINTENANCE PROGRAMME
Any radiotherapy programme requires ongoing maintenance for the teletherapy units,
remote afterloading devices, and any other major pieces of equipment (i e , computers, etc ) A
maintenance strategy determined at the beginning of a project is essential m achieving andmaintaining

a)
b)
c)
d)
e)

low down times
high quality treatments
treatment schedules (fractionation)
patient and staff safety andaccident prevention
Three lines of maintenance can be considereda) in house service for frequent small repairsb) local support by a specialized maintenance company, usually a representative of the supplierc) prompt support by the manufacturer for major repairs
The approach generally taken is a combination of the above The scope and limitations ofeach should be clearly established in writing and the necessary training and certification by the
manufacturer should be arranged No option is inexpensive, but neglect of maintenance is even more
expensive as it can lead to unacceptable and even dangerous consequences The equipment
containing large amounts of radioactive material (^Co units and remote afterloader) may require alicensed source handler to carry out the maintenance
Overall management of the maintenance programme should be provided by the medical
physicist Since maintenance staff will be working around hazardous radioactive materials andpotentially affecting basic safety mechanisms in the devices the help and co-operation of theradiation protection supervisor should be sought The programme should be developed with the cooperation and assistance of the manufacturer of the equipment, and the level of on-site support will
depend partially on the availability of timely support from the manufacturer
Each of the procedures developed as part of this programme should clearly establish who isauthonzed to perform the service, who must be notified before and after service is performed, andwhat records are to be kept After each major repair or preventative maintenance, a complete set of
quality control measurements should be done30

6.4.1 Preventive Maintenance
Procedures should include provision of preventative maintenance services. These
procedures should identify the frequency of service and items to be checked following the
manufacturer's recommendations. A service contract including preventative maintenance may be
preferred since both parts and expertise will be provided by the manufacturer.
6.4.2 Repair

Written procedures should establish who is authorized to work on various components ofthe system, recognizing the hazards and potential consequences associated with different subsystems
and radioactive sources. Specific repair procedures should use the manufacturer's documentationand training materials. Again, a service contract may be the preferred route, since in practice it isdifficult for local staff to maintain the expertise required to repair the equipment when problems
occur infrequently. There should be a formal procedure for notifying the medical physicist any time
there is a repair regardless of its importance. For safety reasons, the medical physicist will decide
the extent of quality control required.

6.43 Spare parts
Funds must be allocated for the purchase of an adequate supply of spare parts to be
maintained on site. A kit of spare parts and sources for parts not included in the kit are necessary.
Maintenance manuals in a major world language and understandable to the users (i.e. themaintenance engineer) are required by BSS (BSS 11.13) [1]. Particular attention should be paid tothe possibility and advisability of substituting components obtained from local vendors. It may becost-effective to do so, but only if the substitutes are of sufficient quality and compatibility.

6.5 INVESTIGATION OF ACCIDENTAL MEDICAL EXPOSURESIn accordance with BSS (BSS 11.29-30) [1]. the following shall be promptly investigated:
any therapeutic treatment delivered to either the wrong patient or the wrong tissue, or using thewrong radioisotope, or with a dose or dose fractionation differing substantially from the values
prescribed by the radiation oncologist or that may lead to undue acute secondary effects.
b) any equipment failure, accident, error, mishap, miscalculation or other unusual occurrence withthe potential for causing a patient dose significantly different from that intended.
In most cases the radiation physicist will be the most appropriate person to undertake suchan investigation which should include:a) a calculation or estimation of the doses received and their distribution within the patient;b) corrective measures required to prevent recurrence of such an accident;c) method to implement any corrective measures.
Following the investigation a report of the incident should be made to the appropriate
hospital safety committee. This report should contain the findings of this investigation. Unless there
is an over-riding medical reason not to, the radiation oncologist, after consultation with the patient's
referring physician, shall inform the patient about the incident in a timely manner.
a)

6.6 QUALITY AUDITS
A quality audit is an independent examination and evaluation of the quality assurance
activities and results. Individuals performing these audits must not be directly responsible for theactivities that are audited. Ideally quality audits review the entire quality assurance process. Quality
audits may be conducted by personnel within the institution as well as those from outside theinstitution. At larger institutions internal audits may include staff members reviewing each others'
treatment plans and outcomes on a scheduled, periodic basis. However, even at larger institutions anexternal review by qualified experts is an important aspect of any quality audit program. In regards
to an external quality audit, the best results are achieved with site visits by outside, qualified
31

experts; however this is an expensive process. A less expensive alternative may include a "selfstudy." This approach involves the outside review team forwarding a packet of questions to which
the reviewed organization responds. The reviewers then evaluate these responses. Other examples ofquality audits of a more limited nature are the postal TLD services that audit radiation source
calibrations. Organizations offering these services include the IAEA/WHO, ESTRO in Europe andthe Radiological Physics Center and Radiation Dosimetry Services in North America.

7. RADIATION PROTECTION AND SAFETY OF SOURCES

7.1 GENERAL
Before initiating construction of the radiotherapy facility, the approval by the Regulatory
Authority has to be obtained. Otherwise, if the safety review by the Regulatory Authority is
performed after initiating construction, it may occur that the Regulatory Authority requires
modifications at a late stage of construction that may be costly or even impracticable in the case ofradiotherapy.
The areas which need to be addressed are listed in Appendix H; typically these areas are thedescription of radiation sources, facility design, managerial and organizational arrangements,
personnel, training, operating procedures and resources.
The application needs to include statements on the arrangements and procedures that thelicensee will observe during construction and operations. In addition, the user should not make anychanges that affect safety without the knowledge of the Regulatory Authority. It the modifications
are substantial and affect safety, the Regulatory Authority may require an additional application.

7.2 ORGANIZATION AND MANAGERIAL MEASURES
7.2.1 Management policy

An overall policy on safety culture, defense-in-depth, and source accountability relies
primarily on the policy that management introduces and supports.
In some serious accidents2, management allowed safety systems to degrade significantly andworkers to improvise procedures or continue operations when a safety system failed, or to operate
without sufficient training, quality assurance programme or documented and rehearsed procedures.
Workers may have perceived that management encourage deviation from procedures in order toperform the job more quickly.
The whole radiation protection programme needs its own defense-in-depth mechanism,
which can be complemented through independent audits of the programme with formal reports
issued to the participants on a periodic basis.
7.2.2 Staffing and training

As discussed in Section 3, sufficient and trained staff has to be assigned and their
responsibilities be clearly defined. With regard to medical exposure in radiotherapy, the overall
responsibility for patient protection, has to be assigned to medical practitioners and calibration,
dosimetry and quality assurance has to be conducted under the supervision of a qualified expert in
The IAEA has developed a repository of information on incidents and accidents with the purpose of disseminating the lessons to be learnedin order to prevent similar events from occurring in any place of the world Periodical reports are planned, the first of them involving
radiotherapy is expected in 1998

32

radiotherapy physics (usually a medical physicist). The duties of the radiation protection officer(RPO) may be covered by the qualified expert in radiotherapy physics (the medical physicist),
depending on the size of the radiotherapy department.
The radiation protection programme cannot rely solely on the above professionals for its
operation. Rather, every staff member who comes into contact with the sources must be trained intheir role for each procedure and in basic radiation safety. These individuals include:a) radiotherapy technologistsb) source handlersc) nursesd) patient transporterse) maintenance engineers or technicians
Each of these individuals needs to be taught to identify the type of source that they workwith and how to know if the source is in a safe or non-safe condition. They must also know what
immediate steps to take during an emergency and especially how to contact the RPO or his designee.
Example syllabus for each category of worker have been given for example by the NCRP [11].
The lines of authority and responsibilities needs to be clearly drawn and documented within
the programme.
7.2.3 Reassessment of training needs

The staffing, responsibilities and training needs are to be reassessed any time theradiotherapy department introduces a new equipment, expands activities, incorporates new treatment
modalities. The reassessment needs to check both the quantity of the personnel available and thetraining. A typical example is the purchase of a new machine with the view to increase the numberof patients to be treated; the introduction of an accelerator or a brachytherapy HDR machine. Staff
needs has to be identified before it becomes insufficient or inadequately trained to operate thedepartment safely, in the case of an expansion. Failure to do so has caused severe accidents
involving a large number of patients [see footnote 2].

7.3 DESCRIPTION OF EQUIPMENT AND SOURCES
The most important safety issue with regards to the safety in design is to ensure that
equipment meets EC and sealed sources meet ISO standards and the applicant needs to clearly
identify the model and manufacturer, since there will be a generic authorization for each model thatis intended to be sold and installed in the country.
It may well be, especially in a developing country, that the equipment is donated after being
used in another country. If the equipment is old, it may not meet safety standards and become aproblem for the recipient rather than a help. In this case, recipients, before accepting a donation
should ensure that equipment meets safety standards and is likely to work safely. For this purpose,
the recipient needs to require:a) a safety assessment of the equipmentb) a quality control test, before the donor decommissions the machine, and submit the test results
to the Regulatory Authority in the recipient countryc) a full, safe and workable maintenance strategy
The full maintenance strategy is especially critical in the case of accelerators, since a wrong
repair can cause severe injuries or even deaths.
Each sealed source should be purchased with a calibration certificate which details it
isotopic activity on a certain date, its encapsulation, and its manufacturer's model and serial number.
The exact source type and size, including encapsulation, is very important information; not only forsource calibration, but also to ensure that the sources are only used with compatible applicators andwith appropriate cleaning techniques.
The recommended working life (RWL) under specified conditions for use need to beobserved. When the RWL is exceeded the sources may still be in good use but a safety assessment
needs to be made and the frequency of wipe and other test may need to be reconsidered.

33

7 4 FACILITY LAYOUT, SHIELDING AND INTERLOCKS
7.4.1 External beam
7411

LayoutInitial considerations for an external beam treatment unit should give careful consideration
to a number of points which will impact the radiation aspects of the programmea) The types of use and proximity of the work and public access spaces beyond the treatment room
will play a major role in the amount of shielding required in each of the barriers It is best to
keep highly occupied areas as far away from the room as possible and conversely surround theroom with spaces that are not able to be occupied or have very low controlled occupancy (suchas a roof which can have access controlled by locks or signs which prevent entry)b) Consideration needs to also be given to the ease of access to the room by patients and for the
installation and replacement of equipment A maze is the most practical solution for Co-60
external beam treatment rooms If well designed, the maze makes a heavy door unnecessary It
should be noted that the staff enters 100 times per day into the room, and heavy doors may
become impracticable Motor dnven doors are expensive and slow and are usually not necessary
for Co-60 irradiation rooms The maze also allows easy penetration of the treatment room vault
over the maze door for ventilation and electrical conduits and only a minimal amount of
scattered radiation will come through the penetrationc) Primary barrier widths should be about 0 67 times the distance from source to the barrier, while
their thickness is determined by the methods discussed in Appendix Jd) It is necessary to supply an open access conduit for equipment cables and test cables near theunit control (Reference to the manufacturer's accompanying documents) This can be done byassuring that the line-of-sight of the conduit does not intercept any surface inside the room
which can be struck by the primary beame) Care should be taken to ensure that there are no voids including conduits in any of the primarybarriersf) Any junction boxes in the secondary walls should be backed with 4 cm of steel with a 3 cm
margin on the sides
An example calculation spreadsheet for a Cobalt 60 therapy source is shown in Appendix J
7412

Interlocks and signs

In addition to layout and shielding considerations there are safety interlocks and procedures
which need to be incorporated into the programmea) The door to the treatment room should have a fail safe interlock to switch off the radiation beam(i e return the source to the shielded position) if the door is opened during the treatment
Restart of the irradiation should require both the closing of the door and activation of a switch
at the control consoleb) The door to the room should have a sign which indicates the room is a radiation area and/or
contains radioactive materialsc) There should be a visible light at the door to the room which shows if the source is on
Typically this will be red when the source is on and green when it is offd) There should be a battery operated scatter radiation detector inside the room which shows when
the source is one) There should be emergency buttons located inside the room to shut off the radiation and theseshould be reachable without passing through the radiation beamf) There should be audio communication from the patient during the treatment34

7.4.2 Brachytherapy
7.4.2.1 Layout and shielding

Low Dose Rate brachytherapy can performed by manually loading the sources into theapplicators, which have been placed into the patient, or by using a remote loading unit which storesthe sources until they are needed and then drives them into position in the applicator.
The remote afterloader acts as its own storage safe and allows one to retract the sources into
the safe position whenever anyone, such as a nurse, needs to be around the patient. Therefore staff
exposures can be kept to a very low level.
With manually loaded sources there is need of an actual shielded and locked container
which is usually kept in a locked room. Security for the sources is of the utmost importance. Thisroom can also serve for loading the sources into the applicators.
If the sources are only the LDR type and they are always stored in a locked shielded safe
within the room, except while loading and unloading the applicators, the room itself does not need
to be shielded. It will usually have a work area with an L-block shield for the source loader to use
while identifying and loading the sources into the applicator. Since sources and their identifying
marks are very small it is useful to have a leaded glass viewing window on the L-block along with amagnifying lens mounted to a light assembly.
The patient rooms which house the LDR brachytherapy patients until they are ready fordischarge, may not need to have shielding in their walls if mobile lead shields around the patient's
bed are made available.
A sink in this room can aid in the cleaning of the applicators. However, the sink ha led also
to loss of sources, for instance, when the patient removed a source and disposed of it through thesink. This can be prevented by placing a filter to prevent any source from falling down the drain.
High Dose Rate remote afterloading units require some special considerations in theirlayout and shielding. Each of the walls, the ceiling and the floor of an HDR room is a primarybarrier and shall be of adequate thickness to protect the staff and public who must remain outside
the room during the treatments. If the source may be positioned anywhere inside the room theresulting calculated barrier thickness can be very large since distance cannot be assumed to aid in
the protection beyond any barrier. Thus it is advisable to require the source to be located within adefined area of the room and to use a chain or electrical interlock to ensure that it cannot be turnedon (i.e. the source driven outside of its protective housing) unless the HDR unit is in that prescribedarea. The room should be designed so that:a) there is an interlock on the door which will cause the source to be retracted into its shielded
housing if the door is opened during the time the source is on,b) there is an indicator at the door to the room as well as at the treatment console of the source 'onoff status,c) there is a battery operated scatter radiation detector inside the room which shows when thesource is on,d) there are emergency procedures for safely removing the source from the patient and quickly
storing it in a safe location in the event that it does not retract all the way into its source housing
when expected. This requires that a wire cutter sufficient to cut the source cable and a shieldedstorage container be located inside the treatment room,e) the door to the room should be marked for the radioactive materials which are within and there
should be an indication of how to contact the responsible radiation safety individual in the eventof an emergency.
7.4.2.2 Interlocks and signs

Doors to the source storage rooms need to be locked and have a sign indicating that there isradioactive materials stored within. There should also be an indication of the responsible person tocontact in the event that entry is needed such as for fire safety purposes.

357.5 INDIVIDUAL MONITORING
Certain staff need to be monitored with individual dosimeters while others, because of thedefined procedures, have their exposures restricted by limiting their access to the radiation sources.
Those most likely to require monitoring are the: radiation oncologists, qualified experts incharge of the radiotherapy physics, RPO, source handlers, and any nursing or other staff who must
spend unrestricted amounts of time with patients who contain sources.
Staff whose access to the sources can be restricted may not need to be monitored directly,
but they will still need to be trained so that they recognize the radiation sources and can comply with
their restricted access.

Visitors and other members of the public need to be supervised by the authorized personnel
and RPO.

7.6 CLASSIFICATION OF AREAS
There are areas in radiotherapy to be classified as controlled or supervised areas as definedby the BSS.
The controlled areas are the treatment rooms for all external beam and brachytherapy
treatments as well as the source storage and preparation rooms. In addition, these areas will require
special access restrictions by means of door interlocks and signs when sources are exposed.
The supervised areas are the operating consoles of the external beam treatment unit and the
HDR unit as well as any area where calculated exposure rates through shielding barriers are likely toresult in exposures of 1 mSv in a year

7.7 RULES AND SUPERVISION
The following procedures need to be prepared:a)emergency: teletherapy, HDRb) wipe testingc) area surveys
d)inventory of radiation sources

7.7.1 Procedures for external beam therapy
Safe operations of external beam treatment units require procedures in place such as: wipe
tests, area surveys, emergency interlock checks, and source status checks; as well as procedures for
emergencies such as a source which becomes stuck in the on or partially on position.
Such procedures require that the necessary equipment be available, calibrated and in goodworking order. These include:a)a radiation monitor GM-type,b) a radiation monitor type ionization chamber, with scales from jiSv to 10 Sv/hr,c) wipe test capabilitiesd) personal alarm dosimeters, especially for emergency intervention.
The procedures for the use of this equipment should recognize that some instruments willlock up in a very high radiation field and read erroneously. Hence the procedure should require athree step process: 1. check the battery 2. check the monitor response with a check source and 3.
turn the monitor on and start reading the radiation dose rate level from outside the room where thesource is located.
7.7.2 Procedures for brachytherapy
LDR and HDR sources have certain operating procedures for their safe use in common:

36a) Source inventories should be performed which show the location and current activity of eachsource at the facility with a unique identifier for each source. This may be either a color codedor letter/number identifier.
b) Sources should never be left on preparation surfaces. They must be in storage, in transit, or in
the patient.
c) Leak tests (using moist wipes) must be performed and documented on a periodic basis and thesemust have a sensitivity sufficient to ensure detect a very low increase above the backgroundradiation. For the HDR unit, the wipe tests are only performed on the afterloading drive
assembly and transport containers since the source itself has too high a dose rate to allow thissort of test.
d) Area surveys should be performed periodically around the source storage facilities for LDR andHDR sources.
e) The storage facilities must be marked to indicate that they contain radioactive materials andhow to contact the responsible radiation safety individual in the event of an emergency.
f) The storage facilities must be kept locked at all times.
g) After every temporary brachytherapy treatment, the patient should be monitored with aradiation detection (GM type) survey meter so ensure that no activity remains in the patient.
h) All source transfers must be done according to the requirements of the Regulatory Authority
and must be done with identified persons who receive and sign for the sources.
Procedures which are unique to LDR sources are:a) The sources should be inspected visually for possible damage after each use by means ofmagnifying viewers and a leaded viewing window in a shielded work area.
b). A diagram at the source storage safe which shows exact locations of each source within thesafe, aids in reducing the time it takes to locate and identify a source.
c) Sources should only be handled with long forceps or tongs,d) When transporting the sources a mobile shielded container is needed and the shortest routepossible should be used.
e) Sources which come into direct contact with body tissues will require cleaning and possible
sterilization after each use. This can subject the sources to possible damage from heat, abrasion,
chemical attack, and mechanical stresses. Therefore these sources must be inspected after every
use.
f) The work surfaces should be easily cleaned and brightly lighted to make it easy to find any
sources which are dropped.
g) If the source storage and preparation room is also the applicator loading room, there should be asink for cleaning of the applicators. However, a sink can also lead to a loss of sources to thesewerage when inadvertently a source is left in the applicator or a patient removes a source andthrows it through the sink. This can be prevented by a filter in its drain.
Procedures which are unique to HDR sources are:h) The HDR afterioader needs to undergo routine QA tests at the beginning of each treatment day.
See AAPM Report [22]i) The couplings and transfer tubes needs to be checked before each HDR treatment to ensure that
there is nothing to prevent the source motion.
j) Emergency safety precautions require having an emergency container available in the treatment
room, as well as an emergency kit containing surgical clamps and long-handled forceps for
manipulation of the source guide tubes and applicators if the source fails to return to the safe, orfor other source retrieval actions. The emergency container should be placed close to the patientand should be sufficiently large enough so that it can accept the entire applicator assembly containing the source - removed from any patientk) Manufacturers provide suggested emergency procedures if the source fails to return to the safe.
These generally are short single page synopsis, suitable for posting, of the necessary sequential
steps involved in the emergency procedure. They assume the physical integrity of the applicator
is maintained. These procedures are specific to the actual afterloading unit but generally involvethe following sequence:
Each step assumes that if the previous action fails to lead to recovery, then the following
action is required. The general sequence is: 1) observation at console of error message and37emergency indicators (audible and visible alarms); 2) recovery at the console (e.g., pressing an
emergency off button): 3) entry into the room with a portable radiation survey meter (opening thedoor activates the interlock that retracts the source); 4) observation of radiation levels in theroom (by mounted monitors or portable survey meters); 5) recovery at the afterloading unit(pressing an emergency off button on the remote afterloading unit (RAU);6) manual retraction of
the source (using a hand crank); 7) patient survey and RAU survey (confirming source is in thesafe); 8) applicator removal and placement in the emergency container; 9) patient survey andemergency container survey (to confirm source is not in the patient and is in the emergency
container); and 10) removal of patient from the vault (with subsequent redundant survey monitor.
7.73 Supervision

Sufficient supervision needs to be exercised in order to avoid a degradation of safety bygiving the impression that management tolerates that procedures are not followed. When supervisors
failed to make the procedures and rules understood or to take actions when rules are violated,
accidents eventually happened. Effective management provides comprehensive safety training tosupervisors and holds supervisors accountable for worker observance of rules and procedures.

7.8 ACCIDENT PREVENTION
When developing a project request the following has to be considered:a) radiotherapy depends largely on human performanceb) there are a large number of steps from the prescription of the treatment to the delivery of theradiation dose,c) interaction and communication between humans from different professions is present in most of
the stepsd) sophisticated equipment is combined with very manual work
It is not surprising that most accidents are due to:a) human mistakes in any of the steps (particularly severe and affecting many patients are errors incommissioning and calibration of the beams and sources).
b) communication errors (including poorly documented data of the treatment)c) misinterpretation of signalsd) failure to recognize an abnormal situation (training is oriented to deal with normal conditions;when something goes wrong, it is rarely recognized early, before it becomes an accident)e) maintenance problems
Human factors leading to accidents do not only apply to radiation emitting devices andsources, but also to treatment planning systems.
When applying for assistance to develop a radiotherapy programme, a sufficient defence-indepth needs to be demonstrated and integrated with radiotherapy quality assurance, in order toprevent that a human mistake or equipment failure results in an accident. This implies:a) Redundant, independent procedures for safety critical steps (for example for calibration ofbeams, two independent persons should determine the absorbed dose)b) Training on accidents case studies to identify and deal with abnormal conditionsc) Written and rehearsed procedures including communication procedures and protocolsd) A thorough maintenance strategy, with provisions to ensure that only personnel with training
and certification of the manufacturer performs repairse) Emergency planning to mitigate the consequences of a human error or equipment faultf) Arrangements for investigating and reporting accidental exposures as defined in the BSS 11.29
and 30, and for deriving and applying preventive and corrective measures, according to theresults of the investigation

38

7.9 EMERGENCY PLANS
The greatest hazard to staff, public and patients occurs when events do not follow accepted
procedures. For such situations there need to be well thought out emergency plans which are concise
and easily followed, and these should be developed before the start-up of a radiation treatment
programme. The types of situations which need to be planned for include:

7.9.1 Lost source
In this event it is critical that an up-to-date inventory exists so that it can be determined
immediately, which source(s) is (are) missing, what is their type and activity, when and where they
where last known to be, and who last took possession of them.
The area where the sources were last know to be should be closed to entry and exit until asurvey has been performed. This search needs to be performed with the most sensitive radiation
detection (usually GM type) survey meter.
7.9.2 Stuck source

There should be emergency procedures posted at the treatment unit for this event. In
general, the first steps are to use the source driving mechanism to return the source to shielding
position (external beam or HDR unit). If this is not immediately successful and there is a patientpresent, the patient must be removed from the source area and the area must be secured from further
entry until the RPO is notified and takes control of the situation.
7.93 Contamination

In this situation radioactive material has spread outside of its container or encapsulation. It
is very important that the area is closed to further entry and that all who were in the area remain tobe surveyed and de-contaminated if necessary. If there are windows or other ventilation present,
these should be closed and the RPO should take control of the situation.
Emergency procedures should be posted at the control console for the event that theradiation source does not turn off. These should deal with the safe evacuation of the patient from theroom and securing the room from further entry until appropriate experts have arrived. There should
also be a statement of how to contact the responsible radiation safety individual in the event of an
emergency.
7.9.4 Patient accidental exposure

The BSS requirements on investigation of accidental medical exposure have been
already referred to in section 6, including incident reporting and corrective measures to be taken.
Formal procedures need to be developed to report and deal with the situation upon detection of an
exposure different than intended.
7.9.5 Staff irradiation
Arrangements and training are needed to recognize an abnormal exposure as well as formal
procedures and prompt communication to the RPO.

39

TABLE III. CLASSIFICATION OF RADIATION AREAS, INTERLOCKS AND CONTROLS
AreaControlled/ or Supervised

Signs

Interlocks
Door interrupt

On/off lightRad. area

Rad materials

1. Ext. beam treatment rm

controlled

yes

yes

yes

yes

2. Ext. beam control console

supervisednoat console

on dooron door

3. LDR source storage rm

controlled

no

yes

4. Manual LDR pt. Treatment rm

controlled

no

no

no

yes

5. Afterloaded LDR pt. treatment rm

controlled

yes

no

yes

yes

6. HDR treatment rm

controlled

yes

yes

yes

yes

no, but door always lockedEl

To provide a high standard of clinical physics service and supervision.

Responsibilities:• Specification of therapy equipment (external beam, brachytherapy,
simulators, CT and imaging systems, and treatment planning systems)
assuring its radiation safety.

The director of the Radiation Oncology department is responsible for theoverall care of the patient.

Responsibilities:

Consultation and clinical evaluation

Establishment of treatment plan, including dose prescription

Treatment execution, participation on a regular basis

On-treatment evaluations and patient monitoring

Treatment summary

Follow-up and evaluation of the treatment

«

•

•

•

•

•

Evaluation and optimization of treatment planning• Supervision of therapy equipment maintenance_______• Establishment of QA procedures in radiotherapy regarding delivery of
the treatment, radiation safety, quality control and regulatory compliance•• Establishment of treatment planning technical aspects and treatment
procedures• Establishment of dose calculation procedures• Measurement and analysis of beam data; tabulation of beam data forclinical use• Acceptance testing, commissioning and QA (including calibration) of
therapy equipment

The Medical Physicist_______(Hospital Physicist. Radiation Oncology Physicist)____The Radiation Oncologist(Physician, Medical Doctor)

Adapted from AAPM TG-40 [4]RESPONSIBILITIES OF THE RADIATION ONCOLOGIST AND
THE MEDICAL PHYSICISTAppendix A

Appendix B
SPECIFICATIONS FOR A TREATMENT SIMULATOR

B.I. TECHNICAL SPECIFICATIONS
All performance specifications and tests shall conform with standards of the International
Electrotechnical Commission (EC) for radiotherapy simulators [12, 13], and of the International
Standards Organization (ISO) for radiation sources[14-16].
Gantry- Gantry motorized with isocentric design- Gantry rotation: 0-360 deg- X-ray focus-isocenter distance ± 80 cm- Isocenter height above floor level < 130 cm- Isocenter maximal sphere 3.0 mm diameter- Hand held control of parameters inside treatment room.
- X-ray Housing and Collimator- X-ray tube and housing, with rotating anode, even in fluoroscopy. Two focii- X-ray beam collimated by motorized diaphragm with both local and remote control.
- Field defined by wires, independent of the X-ray beam diaphragm, motorized with both local andremote control- Projection of the wires shall be < 2.5 mm at the isocenter- Collimator rotation ±100 deg. Manual and/or motorized rotation.
- Optical distance indication range SAD ± 20 cm- Maximal field size at isocenter > 30 cm x 30 cm- Minimal field size at isocenter < 5 cm x 5 cm
- Symmetry better than ± 3 %- Light/radiation field congruence < 2 mm
- Transparent shadow tray
Couch Table- X-ray transparent table top- Isocentric rotation ± 90 deg- Patient lateral motion range ±20 cm- Motorized vertical movement, with minimum height: < 80 cm, and not less than 40 cm
below isocenter, and at least up to 3 cm above the isocenter- Longitudinal range > 70 cm- Table top sag < than 5 mm with a patient of 80 kg
Remote Control Console- Movement and light controls should be provided together with the appropriate X-ray control
switches: gantry, collimator, image intensifier, and couch
X-ray Generator- Fluoro/radiography- 30 kW high frequency generator; otherwise > 50 kW,- Radiography 125 kVp and 300 mAs. Flouroscopy up to 15 mA
Imaging System- Image intensifier with > 23 cm diameter- Image intensifier lateral/ longitudinal movements- Maximum vertical source to input screen distance > 175 cm- 35 cm x 43 cm cassette film holder, including four cassette43

- TV circuit and monitor TV
Options and Accessories- Three lasers for patient centenng- Front pointer- Interlocks devices against collision

B2 SAFETY COMPLIANCE
Compliance with safety requirements in the International Basic Safety Standards forProtection against Ionizing Radiation and for the Safety of Radiation Sources (BSS) [1] and theInternational Electrotechmcal Commission Standards (IEC), shall be substantiated by providing with
the quotation the results of type tests according to IEC [13]B 3 ACCOMPANYING DOCUMENTS
The accompanying documents shall comply with BSS and IEC standards According to the
BSS, Appendix II 13, performance specifications and operating and maintenance instructions shallbe provided in a major world language, understandable to the users The users are primarily
radiographers and maintenance personnel, but also physicists and radiation oncologists may use theequipment
The documentation shall include- Performance specifications- Operating instructions- Installation documents including data to calculate shielding, masses, forces and momentums,
ventilation shafts and conduits for cables, pieces to anchor the equipment and couch during
construction- Preventive maintenance instructions and service manual

B 4 ACCEPTANCE TEST
An acceptance test to comply with the present specifications will be performed by an expert
provided by the Agency
A satisfactory result of the acceptance test is a precondition for payment

B5 WARRANTY AND SERVICE
Hospital administrators typically require warranty and service terms similar to the ones listed
here to prevent lengthy downtimes that may adversely impact patient treatments and or lead to
accidents- Delivery time no more than four months- Specify the time needed for manufacturer-installation This installation shall be included in thepnce- Warranty one year starting after formal acceptance- Maintenance and service (preconditions for the purchase of equipment)+ Training for m-house engineers, in the local language, included in the quotation, specify
duration, location, programme, etc (first-line service)+ Availability of manufacturer service at national or regional level, indicate address of the nearest
service location, number and qualification of the maintenance engineers in that location(second-line service)+ When the above fails to solve the service request, availability of engineer from the factory inless than one week (third-line service)44

+ Permanent service support by immediate specialized response by phone (phone-service) and/or
e-mail; consultation for repair and maintenance in a language understandable to the user (BSS)+ Spare parts kit included. Specify spare parts+ Service rates and conditions; price per hour, per diem, response time, etc.
- Availability of contracted maintenance: up-time3 (> 95 %), with acceptance of penalties for latedelivery of service, extended installations or periods of initial non performance according toequipment specifications- Training of staff (physicians, physicists and operators) in the use of the machine

B.6. GENERAL REMARKS
The equipment quoted in the bid will be supplied with all interconnection devices necessary
for a correct and total function in the country of destination.

3

Up-time is operation without down time (see ref [1])NEXT PACE(S) I
left BLANK I

45

Appendix C
EQUIPMENT REQUIREMENTS FORCOMPUTERIZED TREATMENT PLANNING SYSTEMS
C.I. HARD WARE
- Computer PC based with :+ Screen co-ordinate positioning (joystick, mouse, light pen)
+ Colour display monitor for high resolution presentation of graphics, ( matrix >256 x 256),
multi-presentation (text and images).
- Data input/output devices :+ Digitizer for image size 40 cm x 50 cm or greater+ Resolution better than 0.5 mm- Printer- Plotter-I- DIN A3 format or continuous paper 40 cm wide
+ Number of colours > 4+ Resolution better than 0.5 mm+ Reproducibility better than 0.5 mm

C.2. SOFTWARE
If absolute dose calculations (time) are performed, the system shall provide a detailed list of
all corrections (wedges, tray, decay, etc.) and physical constants (gamma factors, half life, etc.).
External therapy-

2D calculations for 60Co beams
Fixed SSD and isocentric calculations.
Calculation with > 6 simultaneous external beams
Irregular field calculation
Obliquity and distance correction
Tissue inhomogeneity correction
Wedge calculation
Ability to modify contour to accommodate bolus

Brachytherapy-

Source position reconstruction from X-ray film.
Sources : 137Cs, 192Ir, 1251
Correction for source filtration
Support most common gynaecological applicators: Henschke, Fletcher-Suit, Manchester andDelouche.
- Calculation for point and line sources and combination of them
- Source rotation display

47

Data input- Manually acquired patient contours.
- User radiation beams data (possibility for extracting data tables and plotting distributions)- Source position and anatomical landmarks for brachytherapy.
Data output- Real size plots

C.3 OPTIONS-

CT image input
For high energy photon and electron beam 2 5 D2Combination of photon and electron beams.
Combinations of external beams and brachytherapy
Arc therapy treatment planning
Output for customized blocks.
Output plots at varying scale.
Selection of bolus density

C 4. COMPLIANCE WITH STANDARDS AND SAFETY
Since IEC standards on TPSs are not yet available, either- The PDA certification of the US, or- Documented Quality Assurance procedures (e.g. AAPM TG-40 [4]) venfied by a manufacturerindependent quality audit group and published in peer review literature, shall be requested as a
substitute

C 5. ACCOMPANYING DOCUMENTS
The accompanying documents shall comply with the International Basic Safety Standards for
Radiation Protection and the Safety of Radiation Source (BSS) as well as the EC. According to the
BSS, Appendix U.3, "performance specifications and operating and maintenance instructions shall be
provided in a major world language, understandable to the users...". Potential users of TPSs are
medical physicists, radiotherapists, and engineers
The documentation shall include:- Performance specifications.
- Operating instructions- Details on the algorithms used for the calculations- Trouble shooting procedures- Preventive maintenance and service manuals.
- Commitment by the supplier that any changes in software or hardware will be reflected in asimultaneously updated manual.

2

As opposed to 3D, 2 5D means that calculations are performed in 2D, ignoring scattering from adjacent structures/CT
slices, whereas the display can still be done in 3D48

C.6. ACCEPTANCE TEST
An acceptance test to comply with the present specifications shall be performed by an expert
provided by the Agency.
A satisfactory result of the acceptance test shall be a precondition for payment.

C.I. WARRANTY AND SERVICE
Hospital administrators typically require warranty and service terms similar to the ones listed
here to prevent lengthy downtimes that may adversely impact patient treatments and or lead to
accidents.
- Delivery time: no more than four months.
- Specify the time needed for manufacturer-installation. This installation shall be included in theprice.
- Warranty: one year starting after formal definite acceptance- Maintenance and service (preconditions for the purchase of equipment):+ Availability of manufacturer service at national or regional level (indicate address of the nearest
service location, number and qualification of the maintenance engineers in that location)+ When the above fails to solve the service request, availability of engineer from the factory inless than one week
- Service rates and conditions (price per hour, per diem, response time)- Upgrades of purchased items of software at no cost for at least for three years- Training of staff (physicians, physicists and operators) in the use of the system- Permanent service support by immediate qualified response by phone, fax or e-mail for repair andmaintenance.
- Consumables should be available locally- Spare parts kit included in the price. Specify spare parts

C.8. GENERAL REMARKS
The equipment quoted in the bid will be supplied with all interconnection devices necessary
for a correct and total function in the country of destination.

NEXT PAGE(S) "left BLANK

49

Appendix D
SPECIFICATIONS FOR A 60Co TELETHERAPY UNIT AND ITSRADIATION SOURCE

D.I. CLINICAL CONSIDERATIONSThe specifications given below are based on clinical requirements (treatment sites, size oftarget volumes and geometry, treatment time, etc.), as well as on requirements to fulfil treatment
fractionation schemes without clinically unacceptable interruptions. The medical requirement
considerations are the same as those described in a recent joint report by PAHO/WHO/IAEA/UNIDO
on the design of megavoltage x-ray machines for cancer treatment in developing countries [17].

D.2. TECHNICAL SPECIFICATIONS
All performance specifications and tests shall conform with standards of the International
Electrotechnical Commission (EEC) for equipment [12, 18], and of the International Standards
Organization (ISO) for radiation sources [14-16].
Gantry and treatment head-Gantry motorized with isocentric design
Gantry rotation: 0-360 deg
Source isocenter distance SAD > 80 cm
Isocenter height above floor level < 130 cm
Isocenter clearance (with devices inserted) > 15 cm
Isocenter maximal sphere 3.0 mm diameter
Hand held control of parameters inside treatment room
Collimator+ Collimator jaw indication: mechanical or electrical with mechanical backup+ Collimator rotation ±100 deg. Manual and/or motorized rotation- Optical distance indication range: SAD ± 20 cm, with mechanical backup- Secondary collimators (trimmers) to reduce penumbra- Transparent shadow tray for secondary collimation (blocks) to support blocks up to 20 kg. To
allow treatment at any angle with blocks it shall be possible to fix blocking tray to the collimator
without use of hand tools. A standard set of blocks shall be supplied. It shall be possible to use
blocks and wedges simultaneously.
Radiation field-

Maximal field size at isocenter > 30 cm x 30 cm (50% isodose level)
Minimal field size at isocenter < 5 cm x 5 cm (50% isodose level)
Symmetry better than ±3 %Uniformity of ±3 % over 80 % of the field
Light/radiation field congruence < 2 mm
Source diameter < 2.5 cm
A penumbra < 1 cm should be achievable, either with trimmers or blocks
Output >1.5 Gy/min at isocenter (at the depth of dmax) for a 10 cm x 10 cm field at acceptance test.
At least two wedges angles (15 and 45 deg) should be available for 8 cm W x 15 cm. Insertion of51

wedges must not restrict use of secondary collimation Max field size covered by wedge specified
on the wedge Wedges shall be fixed for colhmator and gantry rotation It shall be possible to use
blocks and wedges simultaneously

Couch table-

Table top with transparent window up to the maximal field size
Angle of rotation of the top ± 180 deg
Isocentnc rotation ± 90 deg
Patient lateral motion range ±20 cm (necessary for treatment of lateral fields without moving thepatient, respective of the couch, from initial positioning This shall be achieved either by moving
the table top laterally or by a combination of the isocentnc and column rotation)- Motorized vertical movement, with minimum height < 80 cm, and not less than 40 cm below
isocenter, and at least up to 3 cm above the isocenter- Longitudinal range > 70 cm- Table top sag < 5 mm with a patient of 80 kg
Control console- General ON/OFF key
Options and accessories-

Counterweight or beamstopper
Independent head rotation on arm (range ± 90 deg )Couch table with centred spine section
Area monitor with acoustic/optical signal of radiation
3 Lasers for patient centring
35 cm x 43 cm cassette holder for portal films, including four cassettes
TV closed circuit or window
Immobilization devices for arms, legs and head
BackpointerInter-communicator with the patient (two stations)

D3 SAFETY COMPLIANCE
Compliance with safety requirements in the International Basic Safety Standards forProtection against Ionizing Radiation and for the Safety of Radiation Sources (BSS) [1] and theInternational Electrotechmcal Commission Standards (IEC), shall be substantiated by providing with
the quotation the results of type tests according to IEC-601-2-11 [18]

D 4 ACCOMPANYING DOCUMENTS
The accompanying documents shall comply with BSS, IEC-601-1 and IEC-601-2-11 According
to the BSS, Appendix II3, "performance specifications and operating and maintenance instructions
shall be provided in a major world language, understandable to the users " The users are primarily
radiographers and maintenance personnel, but also physicists and radiation oncologists may use theequipment
The documentation shall include- Performance specifications- Operating instructions- Installation document including data to calculate shielding, masses, forces and momentums,

52

ventilation shafts and conduits for cables, pieces to anchor the equipment and couch during
construction- Preventive maintenance instructions and service manual- Isodose charts

D5 ACCEPTANCE TEST
An acceptance test to comply with the present specifications will be performed by an expert
provided by the Agency
A satisfactory result of the acceptance test is a precondition for payment

D 6. WARRANTY AND SERVICE
Hospital administrators typically require warranty and service terms similar to the ones listed
here to prevent lengthy downtimes that may adversely impact patient treatments and or lead to
accidents- Delivery time no more than four months- Specify the time needed for manufacturer-installation. This installation shall be included in the
price- Warranty one year starting after formal acceptance- Maintenance and service (preconditions for the purchase of equipment)+ Training for m-house engineers, in the local language, included in the quotation, specify
duration, location, programme, etc (first-line service)+ Availability of manufacturer service at national or regional level, indicate address of the nearest
service location, number and qualification of the maintenance engineers in that location(second-line service)+ When the above fails to solve the service request, availability of engineer from the factory inless than one week (third-line service)+ Permanent service support by immediate specialized response by phone (phone-service) and/or
e-mail, consultation for repair and maintenance in a language understandable to the user (BSS)+ Spare pans kit included Specify spare parts+ Service rates and conditions, price per hour, per diem, response time, etc+ Availability of contracted maintenance up-time4 (> 95 %), with acceptance of penalties for latedelivery of service, extended installations or periods of initial non-performance according toequipment specifications+ Price for source replacement should include replacement source and cost of removal of oldsource+ The procedure for source exchange shall not require more than 24 h excluding acceptance test
and Quality Assurance- Training of staff (physicians, physicists and operators) in the use of the machine

D7 GENERAL REMARKS
The equipment quoted in the bid will be supplied with all interconnection devices necessary
for a correct and total function in the country of destination4

Up-time is operation without down time (see ref [1])NEXT PAGE(S) I
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53

Appendix £BASIC EQUIPMENT RECOMMENDED FOR DOSIMETRY IN
EXTERNAL RADIATION THERAPY
Although clinical accelerators are not dealt with in this report, recommendations are included here forcomparison of the minimum equipment needs in different treatment units
Basic equipment

Type of installation
•°Co

LINAC
LINAC
photonswith_______only___electrons
X
X
X

1

lonization chamber Farmer-type, 0 6 cm3 approx , plastic walls(robust), '"Co build-up cap, 10 m cable, 10 m extension cable,
extension connectors calibrated at a Standards Laboratory in terms of
air kerma (do not include calibration in terms of absorbed dose towater until IAEA CoP is available) The chamber model must be
included in IAEA dosimetry publications [7, 8]2Highly recommended, in addition
lonization chamber Farmer-type, 0 6 cm3 approx , graphite walls, ^Co
build-up cap, 10 m cable calibrated at a Standards Laboratory in termsof air kerma (do not include calibration in terms of absorbed dose towater until IAEA CoP is available) The chamber model must be
included in IAEA dosimetry publications [7, 8]

X

3

lonization chamber, 01-03 cm3 approx , cylindrical, 10 m cable

X

(max

electrode diameter 1 mm)

4Radioactive source for checking stability of cylindrical lonizationchambers

5

Plane-parallel lonization chamber for electrons (mm guard ring 4mm)
The chamber model must be included in IAEA dosimetry

X

X

X

X

X

X

X

X

publications [7, 8]

6Electrometer compatible with chambers above and following specs in
IAEA dosimetry publications [7, 8], calibrated or compared at aStandards Laboratory

7

Additional electrometer with varying voltage bias (V1/V2 ratio equal
or greater than 3), possibility to reverse the polarity

8

Water phantom for calibration and checks, 20x20x 10 cm3 approx ,PMMA walls, including holder for lonization chambers

9

Water phantom for calibration, 30x40x40 cm3 approx , PMMA walls,
including holder for ion chambers with manual steps or automatic
system to vary the position of the chamber

10

Plastic slab phantom for verification of field size and coincidence ofradiation and light field Used also for output verification, with holes
for the chambers, and TLD

X

11 Barometer (mm scale 1 mb or hPa, or 0 5 mm Hg), pref aneroid typeor digital, calibrated or compared at a Standards Laboratory

X

X

X

55

Type of installation

Basic equipment

LINAC
photons

LINAC
with

only___electrons

12

Thermometer (mm scale 0.25 deg C), calibrated or compared at aStandards Laboratory

X

13

Densitometer to measure x-ray film optical density, with manual
reader and co-ordinate system
OD cal. film-stnp for check of instrument OD scale.

X

Requires having access to film development

14

Densitometer to measure x-ray film optical density, with automatic
register and co-ordinate system.
OD cal. film-stnp for check of instrument OD scale
Requires having access to film development

15

Radiation field analyser to measure isodose distributions, 50x50x40
cm3 approx water tank, phantom trolley with vertical movement,

X

X

water pump

Supplementary equipment
X
X

X
X

X

X

X

X

X

X

1 TLD system (both redundant dosimetry and "in-vivo")
2. Array of diodes or ion-chambers for Quality Assurance daily checks
3 Precision water level
4. Calliper, metal ruler

5. Multi-meter (volt, ohm)

X

ADDITIONAL EQUIPMENT FOR LOW-ENERGY X-RAYS DOSIMETRY

For the range of qualities from 100 to 300 kV items in the previous list can be used if theionization chamber is calibrated at a Standards Laboratory over the range of qualities in clinical use.
Below 100 kV the following equipment is required.
1. Ionization chamber for kV X-rays, parallel-plate 0.3 cm3, 10 m cablecalibrated at a Standards Laboratory in terms of air kerma for x-rays, at least for three calibration
qualities between
10 kV and 100 kV. Both the kV and the HVL should be stated in the calibration certificate
2 Plastic phantom for kV X-rays parallel-plate ion chamber

56

Appendix F
COMPARISON BETWEEN HIGH-DOSE-RATE (HDR) AND LOWDOSE-RATE (LDR) BRACHYTHERAPY
The comparison between HDR and LDR brachytherapy is complex and depends upon many
variables and the end points chosen from the comparison. If there was a clear clinical advantage of
one over the other (e.g. an improved survival rate with comparable or less complications) then the
choice, as to which to use, might be easier. As it is no such distinction now exists and the choice must
depend upon other factors.
The types of clinical cases most frequently seen at a given institution might help. If a large
number of bronchogenic and oesophageal cancers are seen then HDR brachytherapy might bepreferred because these cases are difficult if not impossible to treat with LDR.
However it is likely that the clinical cases most frequently seen are gynaecological tumours
which can be treated well with either HDR or LDR.
If LDR brachytherapy is performed then the treatment may proceed along the following lines:- Applicator insertion in the operating room under general anaesthesia (or possibly a spinal block).
Radiation Oncologist, anaesthesiologist and support staff need to be present.
- Verification of applicator position using mobile X-ray unit.
- Removal of patient to the Imaging department. Orthogonal X-ray taken. Subsequently patient taken
to hospital room.
- Radiation Oncologist, physicist, dosimetrist review the films and decide upon number and strengthof sources to be used.
- Treatment planning computer calculation of the isodose distribution around implant. Anticipatedsource loading could be changed. Length of treatment time calculated.
- Dosimetrist, physicist, or source curator prepares the sources, in the source preparation room, forloading.
- Source loaded (manually) into the applicator in the patient implants in hospital room by trained
personnel. Although this room should ideally be shielded, bedside shields, distance and reduced
occupancy in adjacent rooms can be used as a substitute- Patient in the hospital for several days, time for nursing care limited by radiation and visits
restricted.
- Sources removed by the trained personnel occasionally some of the sources may be removed
earlier or later than planned to obtain a desired dose distribution- Patient discharged.
- The patient may return in a couple of weeks for a second treatment.
Several such procedures could be done on any given day. Generally the number is restricted by
the availability of sources, applicators, operation room and hospital beds.
Modifications of this approach will take place if remote afterloading in used. However theoverall approach is the same.
For HDR remote afterloading, the procedure may be as follows:- Applicator insertion in the special procedures room under sedation (or local anaesthesia).
Radiation Oncologist and support staff present.
- Verification of applicator position and taking of orthogonal films with the special diagnostic
radiation equipment (Often a treatment simulator).
- Removal of patient to a holding area to wait for dose calculations- Dose calculations by the physicist in conjunction with the radiation oncologist on the treatment
planning computer using the orthogonal films.
- Patient moved to the treatment room and remote afterloader programmed to deliver the desired
treatment.
- Treatment given. This will take several minutes. Physicist will be present during the treatment.
- Patient taken back to the procedures room for the removal of the applicators.

57

- Patient is allowed to go home.
- Patient returns several times at intervals dependent on the fractionation schedule to complete
treatment. The above procedure will be repeated every time.
It is essential to recognize that no more than 3-8 HDR procedures can be performed per day on
a single machine, depending on the complexity of treatment planning required. For example, if 200
cases of locally advanced cervix carcinoma are anticipated, and each patient is to receive 4 fractions,an average daily load of 3-4 procedures per day will be expected. Since the primary advantages of
HDR over LDR are potential cost savings and patient convenience, institutions should weigh carefully
the advantages and disadvantages of HDR. HDR treatments dramatically increase the physician andphysicist resources that must be allocated to brachytherapy while reducing the need for inpatient beds.
The relative cost and availability of these resources should be compared and the cost savings, if any,
compared to the cost of amortizing the capital investment required and costs of source replacement
and machine maintenance.

58Appendix G
SPECIFICATION OF EQUIPMENT FOR REMOTE LDR AND HDR
AFTERLOADING BRACHYTHERAPY

G 1 EQUIPMENT FOR LOW-DOSE-RATE (LDR)
BRACHYTHERAPY

G.I.I

AFTERLOADINGTechnical Specifications

All performance specifications and tests shall conform with standards of the International
Electrotechmcal Commission (EC) for equipment, and of the International Standards Organization(ISO) for radiation sources It is required- Source positioning reproducibihty ±1 mm- Automatic power-failure source retraction- Intermediate source storage container- Minimum of 3 source channels for intracavitary and endolurmnal treatments, 4 source channels
highly desirable- Remote nurse alarm station

G.I.2. Safety compliance
Shall comply with the International Basic Safety Standards for Protection against Ionizing
Radiation and for the Safety of Radiation Sources (BSS)[1] and the relevant EC standards [19]G.I.3. Accompanying documents-

Shall comply with the BSS as well as the relevant IEC standards- Performance specifications- Operating instructions- Installation documents including requirements on shielding, power, ventilation, compressed air or
any other items- Preventive maintenance and service manuals- Source exchange instructions

G.1.4. Acceptance test

An acceptance test to show compliance with agreed upon specifications will be performed by
an expert provided by the Agency

A satisfactory result is a precondition for payment
G.1.5. Warranty and service- Delivery within four months, specify installation time
- One year warranty starting on acceptance date
- Maintenance and service training for hospital engineer, present availability of manufacturer
service at national or regional level (give address and number of qualified engineers)- Training of staff (physicians, physicists and operators) in the use of the equipment- Prices shall include transportation and installation- Price for source exchange, including rates for disposal of old sources and including transportation

59

G.I.6. general remarks

The equipment quoted in the bid will be supplied with all interconnection devices necessary
for a correct and total function in the country of destination
G 2 MINIMUM EQUIPMENT RECOMMENDED FOR LOW-DOSE-RATE (LDR)
BRACHYTHERAPYManualLDR

RemoteLDR"Ir source loading and cutting devices

X

X

2

Source storage and transport containers (for Remote LDR this should be part ofthe equipment) within the department

X

X

3

Source handling instruments and accessories (in source preparation room andpatient loading room)X

4

Area radiation monitor in treatment room with light signal outside the entrance
door, power-fail-safe

X

X

5

Portable radiation monitor instrument

X

X

6

Highly recommended Area radiation monitor with audio signal at the entrance
to the treatment room

X

X

7

Emergency container and emergency source handling instruments at thetreatment room

X

X

8

Radioactive waste storage

X

X

9

Equipment for source/applicator localization and identification (e g X-ray)

X

X

10

Dummy sources for applicator localization in patient

X

X

11

Patient couch adapted for LDR brachytherapy applications gyn , H&N,
bronch (leg rests, film cassette holders, anaesthesia requirements, etc )

X

X

12

Device for fixation of connector between transportation tube-applicator tubes topatient13

Set of applicators for intracavitary (e g Henschke, Fletcher-Suit, Manchester orDelouche type) and interstitial treatments

X

14

Radiation protection barrier for source loading in patients and for patient careX

15 Portable radiation protection bamers in case of insufficient protection inX___patient ward walls and door__________________________________

60

G.3. EQUIPMENT FOR REMOTE HIGH-DOSE-RATE (HDR)
BRACHYTHERAPY

AFTERLOADING

G.3.1. Technical Specifications

All performance specifications and tests shall conform with the relevant standards of the IEC(as no EEC standard exists for HDR equipment at the time of writing, relevant parts of that for low
dose rate equipment shall be used) and the International Standards Organization (ISO). Alternatively
the AAPM report No 41 [20] and AAPM recommendations by TG-43 and TG-56 [21, 22] should be
used.
- Manual emergency source retraction- Automatic power-failure source retraction- Source positioning reproducibility ±1 mm- Minimum of 3 source channels for intracavitary and endoluminal treatments; 4 source channels,
highly desirable- TPS including optimization, treatment parameter transfer to treatment unit
- Automatic correction for source decay in case of 192Ir- Dummy source simulation before treatment
G.3.2. Safety Compliance

Shall comply with the International Basic Safety Standards for Protection against Ionizing
Radiation and for the Safety of Radiation Sources (BSS) [1] and the relevant IEC standards [12, 19].
G.33. Accompanying Documents

Shall comply with the BSS as well as the relevant IEC standards- Performance specifications- Operating instructions- Installation documents including requirements on shielding, power, ventilation, compressed air or
any other items- Preventive maintenance and service manuals- Source exchange instructions
G.3.4. Acceptance Test

An acceptance test to show compliance with agreed upon specifications will be performed by
an expert provided by the Agency.
A satisfactory result is a precondition for payment.
G.3.5. Warranty and Service- Delivery within four months; specify installation time
- One year warranty starting on acceptance date
- Maintenance and service: training for hospital engineer, present availability of manufacturer
service at national or regional level (give address and number of qualified engineers)- Prices shall include transportation and installation- Price for source exchange, including rates for disposal of old sources and including transportation

G.3.6. Genera] Remarks
The equipment quoted in the bid will be supplied with all interconnection devices necessary
for a correct and total function in the country of destination.

61

G 4 MINIMUM EQUIPMENT RECOMMENDED FOR HIGH DOSE RATE (HDR)
BRACHYTHERAPY
NoteHigh dose rate brach\therapy is potentially a high risk technique and extreme accuracy and care isessential Adequate and well trained staff (radiation oncologists, physicists, nurses etc ) is required In addition
the expected increase in number of patients should be accompanied by a corresponding increase of staff
members The short response time required for emergency actions (minutes) imposes the need for the presence ofboth a physician and physicist trained in emergence procedures during all applications

1 Area radiation monitor in treatment room connected to the door interlock with power-fail-safe audio signal
independent of treatment equipment
2 Portable radiation monitor instrument at the entrance of the treatment room door
3 Highly recommended Area radiation monitor with audio signal at the entrance to the treatment room
4 Emergency container and emergency source handling devices at the entrance of the treatment room door
5 Equipment for applicator localization and identification (e g X-ray unit)
6 Dummy sources for applicator localization
7 Treatment coach adapted for HDR brachytherapy gyn , bronch (leg rests, film cassette holders, anaesthesia
requirements, etc)
8 Set of applicators for intracavitary (e g Henschke, Fletcher-Suit, Manchester or Delouche type) andendolummal treatments
9 Device for applicator fixation to treatment coach__________________________________

G 5 MINIMUM EQUIPMENT RECOMMENDED FOR IMPLEMENTING QUALITYASSURANCE PROGRAMMES IN BRACHYTHERAPY
Items

Type of installation
ManualLDR

Well-type icnization chamber or Isotope Calibrator with source holding
inserts, calibrated at a Standards Laboratory for the clinical sources
available
If '37Cs sources are not available a long-lived reference source for

X

RemoteLDR
X

Remote HDR

X

X

X

checking well chamber stability
Facility to verify source homogeneity
Requires having access to film developmentandsourcepositionX

Barometer (mm scale) 1 mb or 0 5 mm Hg), pref aneroid type or digital,
calibrated or compared at a Standards Laboratory (if not available inexternal radiotherapy)
Thermometer (mm scale 0 25 deg C), calibrated or compared atStandard Laboratory (if not available in external radiotherapy)
Caliper, metal ruler

62

X

X

Appendix H
LICENSING

H.I. APPLICATION FOR AUTHORIZATION AND SAFETY REVIEW PLAN FOR
RADIOTHERAPYTYPE OF AUTHORIZATION___ New Application___ Amendment to existing authorization number:___ Renewal of Authorization number: ______PURPOSE OF APPLICATION___ Construction (Complete Sections I through III)___ Import/Purchase (Complete Sections I and II)___ Use/Begin operation (Complete Sections I through V)
You may refer to previous submissions by date and application or authorization numbers).

The legal person who will be responsible for using any sealed source or radiation generator must,
unless the source is exempted, submit the following information to the regulatory authority.

GENERAL INFORMATIONName and Address of organisation:
Main address
Mailing address (if different)

Name and information about qualified experts:
Expertise: Radiation Protection Officer
Name: _____________________
Degree: ____________________

Address of use (if different)

Expertise: Radiation Oncology
Name: ___
Degree: __Certification: ____________________

Certification:

Experience: __________________

Experience:

Telephone number:

Expertise: Radiotherapy Physics
Name: ___
Degree: __Certification:.
Experience: _Expertise:
Name: ____
Degree: ___Certification: _Experience: _63

The responsible representative of the legal person:

Name: _____________________

Telephone number.

Title: _______________________

Facsimile number _e-mail address __Proposed date of installation and/or commissioning of facilities and equipment:

SIGNATURE AND CERTIFICATION

Signature of the authorised representative of the legal person
Printed name: __________________________
Title: _________________________________

Date: ________________________________
Notes:

1. The Regulatory Authority may require additional information to fully consider this application
prior to issuing an authorization.

2. In the event that all the above information is not available at the time of application, theRegulatory Authority may issue an authorization limiting the applicant to import, acquire, or store
radiation sources, or construct facilities. Complete information will be required from theapplicant prior to authorising use of the radiation sources.
3. Medical exposure may be under the jurisdiction of a regulatory authority other than the regulatoryauthority responsible for occupational and public exposure. However, the authorised user should

address the items in Section Vfor referral to any appropriate authority.

64H.2. SOURCES AND EQUIPMENT
For external beam therapy specify the following:
Type: (Accelerator, x-ray generator, or gamma)

Name of manufacturer:_______________
Address:

Model No. and Name:Country of manufacture:.

Year of manufacture:
Type of gantry: (Stationary or rotary)
Output Gy/min at isocenter: ______

Describe the movement of the treatment table:

a. For Gamma external beam units:
i)
ii)
iii)
iv)
v)
vi)
vii)

Radionuclide:
Model No. of the source:
Initial activity of sources:
Number of units installed:
Maximum design activity of the associated equipment:
Total activity installed:
Types of source carrier or shutter (exposure mechanism):b. For Accelerators:i)Maximum energy (MeV) or nominal accelerating potential (kV, MV):ii)
Maximum current (mA):
For External beam therapy, describe the features that will be available, including:a. External Beam Therapy Electrical Indicators/ Interlocks (treatment room door, head lock, offshield, hand control, treatment mode - Fixed / Arc / Skip / Rotation, treatment angle, source draweror shutter, emergency stop buttons to interrupt the irradiation, head collision switch, fixed area
radiation monitor).
b. External Beam Source Head Displays (Beam "OFF" indicator, beam "ON" indicator, head lockindicator, collimator rotation indicator, off shield indicator, light field displays).
i)performance specifications and operating and maintenance instructions, including
protection and safety instructions, be provided in a major world language
understandable to the users and in compliance with the relevant EC or ISO

65

ii)

standards with regard to "accompanying documents," and that this information betranslated into local languages when appropriate;
where practicable, the operating terminology (or its abbreviations) and operating
values be displayed on operating consoles in a major world language acceptable tothe user.

c. Teletherapy Control Console Displays (beam "OFF" indicator, beam "ON" indicator, head lockindicator, off shield indicator, arm position indicator, door position indicator).

d. Teletherapy Control Console Functionsi)power switchii)
reset switchiii)
beam "ON" switch
iv)
beam "OFF" switchv)
timer switch (with treatment & elapsed time displays)vi)
treatment mode selection switch - Fixed/ Arc/ Skipvii)
rotation selection switch for clockwise & anti-clockwise rotation)
For brachytherapy, specify:
Devices:
Manufacturer:

Sources:
Manufacturer:

Model Radionuclide:No:

Type ofloading:
Manual (M)Remote (R)
M R
M R
M R
M R

Dose Rate: Number Maximum
High (H)ActivityofLow (L) Channels:(Remote)
H L
H L
H L
H L

Total
Number ofModel Radionuclide: Physical type: Physicaldimensions
No:
Ribbon (R)Activitysources:
Wire (W)and shape (per cm (total activity
Individual (I)for wires for wire)andribbons)
R W I
R W I
R W I
R W I
R W I
R W I
R W I

Standards
Indicate to which IEC and ISO standards does the equipment and sources used for medical exposure
conform:

For remotely loaded brachytherapy sources, describe the equipment features including:a. Door to treatment room electrically interlocked with source movement mechanism, andb. Fixed area radiation monitor.

66

For manual brachytherapy, describe source handling devices that will be available including:a. Source storage and transport container,
b. Source handling devices and accessories (such as tongs, lead containers, etc.), andc. Radiation protection barrier during manual source loading in patient.
Servicing of equipment
Identify who will be authorised to perform service and maintenance on the equipment and theirauthorization number:

H.3. FACILITIESApproval should be obtained from the Regulatory Authority before starting construction of thetreatment rooms.

In an attachment to this application, describe the facilities, including:

Location of the facility
Provide a detailed description of the location of the radiotherapy facilities including surrounding
structures or rooms and activities.

Layout of facilities
Describe factors such as the layout of the facility and its safety systems, including:a. building materials,
b. alarms,c. shielding,d. engineering controls (mechanical interlocks, warning safety devices, emergency stop buttons
inside/outside enclosure, prevention of unauthorised personnel entering area, and means of escapeor communication from within enclosure).
Sketch or drawing
Attach a detailed sketch or drawing of the facility showing the above details. Include on the drawings
any penetrations or openings in the shielding materials such as conduits or ventilation ducts.

Dose rate calculations
Taking into account existing shielding, provide calculations of the maximum dose rates expected in
all areas outside the treatment room(s) which could be occupied. For these calculations, assume any
radiation beam is oriented in the position that would result in the highest directional exposures.
Include a statement of all assumptions used in the calculations.

H.4. RADIATION PROTECTION AND SAFETY PROGRAMMEIn an attachment to this application, describe the radiation protection programme, including:

Organisational structurea. Describe your organisation and management control systems including assignment ofresponsibilities related to radiation safety. In particular include: staffing levels, equipment
selection, other assignments of the Radiation Protection Officer, authority of the Radiation
Protection Officer to stop unsafe operations, personnel training, and maintenance of records.

67

b. Identify the authorised users, radiation physicist, and Radiation Protection Officer by name andinclude their training, qualifications, and experience. (Note: the authorised user, radiation

physicist, and/or Radiation Protection Officer may be the same individual).

c. Confirm that training will include: explanation of written procedures, use of equipment (radiation
source and instrumentation), meanings of warning signals, and a method to confirm adequacy of
training (testing or demonstrations).
Individual monitoring and classification and monitoring of areasa. Describe your programme for monitoring the workplace (BSS, 1.37-1.40), including: the quantities
to be measured, where and when the measurements are to be made, the measurement methods andprocedures, and reference levels and the actions to be taken if they are exceeded.
b. Describe your policies and procedures for classification of controlled and supervised areas. (BSS,
I.21-I.25).
c. Describe personal dosimeters provided to workers and your policies for assigning dosimetry toindividual workers (BSS, I.32-I.36).
Denote type:
i)
Film
ii)
ThermoLuminescent Dosimeter (TLD)
iii)
Direct Reading Dosimeter (DRD)iv)
other: _____________________

Local rules and supervision
a. Describe your local rules and procedures regarding: investigation or authorised levels, protective
measures and safety provisions, providing adequate supervision, providing workers information
regarding health risks due to occupational exposure, and emergency planning instruction (BSS,
I.26-I.27).

b. Provide copies of your operating and safety procedures including: area access control, entry
procedures, source inventory and leak testing , etc.
c. Describe your training program to ensure all appropriate personnel are adequately trained in theoperating procedures (BSS, 1.27).
d. Describe your policies regarding notification by female workers of pregnancy and the instructions
you will provide to female workers (BSS, 1.16-1.17 and 1.27).
e. Describe your programme of health surveillance based on general principles of occupational healthand designed to assess the initial and continuing fitness of workers for their intended tasks (BSS,
I.41-I.43).

Quality assurance
a. Describe your program to periodically review procedures, maintain procedures current andavailable, and your procedure modification process.
b. Describe your program for optimising occupational and public exposures to levels as low asreasonably achievable.

Transportation of radioactive material
If you will be transporting or shipping new or used sources, describe your arrangements for
preparation and transport of packages containing radioactive sources (IAEA Safety Series 6). These
procedures should address: documentation of package certification, package surveys, transfer / receipt
documents, and details of shipments preparation.

68

Emergency procedures
Provide your emergency procedures to address potential emergencies such as potential damage to thesource, loss of source shielding, or stuck sources, and misadministration to patients. If otheremergencies are envisaged, please provide additional appropriate emergency procedures.

Transfer or disposal of radioactive sources
Describe arrangements for transfer or disposal of spent radioactive sources.
System of Records (BSS; 2.40,1.44-I.49,11.31-1132), including:a. Disposal of spent sourcesb. Personnel exposurei)current records
ii)prior work historyc. Area surveysi)dose or dose rateii)
contaminationd. Instrument tests and calibrations
e. Tests for radioactive sealed source leakage,f. Inventory of sources and accountability
g. Audits and reviews of radiation safety program
h. Incident and accident investigation reports
i. Maintenance and repair work
j. Facility modifications
k. Training provided
1. Evidence of health surveillance of workers
m. Transportation
n. Patient discharge surveyso. Clinical dosimetry records

H.5. MEDICAL EXPOSURE
If appropriate for the purposes of the Regulatory Authority, in an attachment to this application,
describe the programme to control medical exposure, including:(BSS requirements related to this section may be found in Appendix II "Medical Exposure. ")Responsibilities for medical exposurea. Describe your arrangements to assure that patient treatment will only be prescribed by medical

practitioners.
b. Describe your arrangements to assure that calibration, dosimetry and quality assurance
requirements for therapy are conducted by or under the supervision of a qualified expert inradiotherapy physics.

c. Describe criteria and arrangements to ensure an adequate number of trained medical andparamedical personnel to discharge assigned tasks.
Justification of medical exposures

a. Describe your arrangements to ensure that the therapeutic benefits will be weighted against theradiation detriment they might cause, taking into account the benefits and risks of available
alternative techniques that do not involve medical exposure.
b. Confirm that exposure of humans for medical research will always be in accordance with theHelsinki Declaration and will follow the guidelines for its application prepared by the Council forInternational Organizations of Medical Sciences and the World Health Organisation.
69

c Confirm that each exposure of humans for medical research is subject to the advice of an Ethical
Review Committee or other similar institutional body
Optimisation of patient protection

a Descnbe your arrangements to ensure that with regard to equipment consisting of radiation
generators or containing sealed sources for medical exposuresb the equipment conforms to applicable standards of the International Electrotechmcal Commission(DEC) and the ISO or to equivalent national standards (whether imported into or manufactured in
the country where it is used),c performance specifications and operating and maintenance instructions, including protection andsafety instructions, will be provided in a major world language understandable to the users and incompliance with the relevant EC or ISO standards with regard to "accompanying documents", andthat this information be translated into local languages when appropriate,d where practicable, the operating terminology (or its abbreviations) and operating values will be
displayed on operating consoles, in a major world language acceptable to the user
Calibrationa Descnbe your systems to ensure the calibration of sources used for medical is exposure traceable
to a Standards dosimetry laboratoryb Descnbe radiotherapy equipment calibration in terms of radiation quality or energy and either
absorbed dose or absorbed dose rate at a predefined distance under specified conditions (IAEA
Technical Report Senes No 277 )c Descnbe procedures for calibration of sealed sources as of a reference date, for activity or at a

specific distance in terms of reference air kerma in air or absorbed dose rate in a specific medium
d Descnbe your programme of calibration to be earned out at commissioning of a unit, after
maintenance that could affect dosimetry and at penodic intervals
Clinical dosimetry

Descnbe your arrangements to ensure determination and documentation of
a in radiological examinations, representative values for typical sized adult patients of entrance
surface doses, dose-area products, dose rates and exposure times, or organ doses,b for each patient treated with external beam radiotherapy equipment, the maximum and minimum
absorbed doses to the planning target volume together with the absorbed dose to a relevant pointsuch as the centre of the planning target volume, plus the dose to other relevant points selected by
the medical practitioner prescnbing the treatment,c in brachytherapeutic treatments performed with sealed sources, the absorbed doses at selected
relevant points in each patient,d in diagnosis or treatment with unsealed sources, representative absorbed doses to patients, ande in all radiotherapeutic treatments, the absorbed doses to relevant organs
Quality assurance for medical exposure

Descnbe your quality assurance programme (BSS II 22) which should include the items listed below
The programme must include arrangements made to insure that the radiotherapy equipment beavailable during enough time to carry out the Quality Control measurementsa Verification of the appropnate physical and clinical factors used in treatment including
measurements of physical parameters at the time of commissioning and periodically thereafterb Written records of relevant procedures and results70

c. Verification of the appropriate calibration and conditions of operation of dosimetry and monitoring
equipment.

d. Verification of patient identity.
e. Regular and independent quality audit reviews.

Investigation of accidental medical exposure
Describe the procedures to promptly investigate any of the following incidents:
a. any therapeutic treatment delivered to either the wrong patient or the wrong tissue, or using thewrong pharmaceutical, or with a dose fractionation differing substantially from the values
prescribed by the medical practitioner or which may lead to undue acute secondary effects;
b. any diagnostic exposure substantially greater than intended or resulting in doses repeatedly andsubstantially exceeding the established guidance levels; andc. any equipment failure, accident, error, mishap or other unusual occurrence with the potential forcausing a patient exposure significantly different from that intended.
With respect to any investigation:a. calculate or estimate the doses received and their distribution within the patient;b. indicate the corrective measures required to prevent recurrence of such an incident;c. implement all the corrective measures that are under their own responsibility;
d. submit to the Regulatory Authority, as soon as possible after the investigation or as otherwise
specified by the Regulatory Authority, a written report which states the cause of the incident andincludes the information specified in (a) to (c), as relevant, and any other information required by
the Regulatory Authority; ande. inform the patient and his or her doctor about the incident.
Dose constraints to comforters and visitors to patients
Describe your procedures to ensure that the dose of any comforter or visitor of patients beunlikely to exceed 5 mSv during the patient's treatment.

71

Appendix I
CONSIDERATIONS FOR A QUALITY ASSURANCE PROGRAMME IN
RADIATION ONCOLOGY

I.I. INTRODUCTION
The role of quality assurance in radiation oncology has received increasing attention in thelast few years and its importance is now fully recognized in maintaining consistent accuracy of theabsorbed dose delivered to patients undergoing radiation therapy [4, 9, 10, 23]. Sources of error canderive from deficiencies in tumour localization, patient immobilization, field placement, daily patient
set-up, dose calibration and calculation as well as from equipment related problems.

As already introduced in Section 6, the quality assurance program in radiation therapy,
therefore, covers a wide range of areas, often involving several medical disciplines and the medical
institution's management. Co-ordination, therefore, is critical among medical physicists, dosimetrists,
maintenance engineers, radiation oncologists, radiotherapy technologists (radiographers), othermedical disciplines and management. In many institutions the medical physicist is best placed tooversee such a program.
The aim of a physics quality control (QC) program for radiation therapy is an ongoingevaluation of the functional performance characteristics of the associated equipment and calculations,because these characteristics influence both the geometrical and dosimetric accuracy of the applied
dose. There are two main parts of such a program: (i) periodic QC measurements and evaluation and(ii) regular preventative maintenance. The medical physicist should be responsible for making surethat both parts of the program are carried out.
The three main areas for sources of inaccuracy in dose delivery can be identified as:a) Physical dosimetry, i.e., the commissioning and calibration of treatment machines and sources.
b) Treatment planning, i.e., the delineation of the target volume and critical structures, acquisition ofpatient specific factors and dose distribution calculations.
c) Patient treatment, i.e., the set-up of the patient and the recording of the treatment and final
verification of the accuracy of the delivered dose.
Any equipment QC program will be based upon a complete determination of baseline values
at the time of acceptance and commissioning of the equipment. Data for any machine should not beassumed to be identical to similar machines until verified. Most manufacturers provide in written
form, their acceptance test procedures which list the mechanical and radiation parameters that will
provide the benchmark for the equipment. Commissioning provides the detailed information about theequipment, e.g., tables of beam data. This data obtained for each piece of equipment adds to thebenchmark data. Once the acceptance tests, commissioning and calibrations have been completed a
QC program must commence to insure that the accuracy of the treatments is maintained, i.e., the goalof such a program is to assure that the performance characteristics established during commissioningshows no serious deviations. A QC programme also provides data and techniques to be used following
any machine repairs. It is essential that the management of the installation makes the appropriatearrangements to insure that the radiotherapy equipment is available to the medical physicists to carryout the Quality Control measurements.
Many references in this appendix are made to the publication "Comprehensive QA forradiation oncology. Report of AAPM Radiation Therapy Committee Task Group 40," by Kutcher etal, Med. Phys. 21:581-618, 1994 [4]. This publication will subsequently be referred to as AAPM TG40. Detailed QC procedures can also be found in various other publications [24, 25].

73

I 2 THE QC PROGRAM IN RADIATION THERAPY
QC in a radiation therapy department covers a wide range of activities and the treatment
process can be viewed in many different ways. For the purposes of this discussion four main areas

have been identified They area) External Beam Treatmentsb) Brachytherapy Treatmentsc) Measurement Equipmentd) Clinical Aspects of the Treatments
In developing a QC program it is important to use measurement techniques that are simple
and rapid to minimize the test time and reproducible at a level adequate to determine parameterchanges smaller than the tolerance or action level

1.3 THE QC OF ^CO UNITS
Recommended QC tests for ^Co units are given in Table 11 It should be noted that in many
countnes the specification, performance and quality control of ^Co teletherapy units may be
mandated by governmental regulations If this is the case then these governmental regulations must be
adhered to

14 THE QC OF SIMULATORS
Since simulators are designed to reproduce the geometric conditions of the radiation therapy
equipment they are subject to the same mechanical checks as the treatment unit In addition, thesimulator should be checked for image quality according to guidelines for diagnostic radiography
units [26, 27] Table III summarizes the QC tests for simulators

15 THE QC OF EXTERNAL BEAM MEASUREMENT EQUIPMENT
The measurement equipment is equally important as the radiation treatment equipment andshould be part of the QC program The recommended QC tests, frequency, and tolerance limits are
given in Table I III
Redundancy is an important part of any QC programme The IAEA/WHO TLD postal systemprovides a redundant dose measuring system Redundancy in dose calibration equipment is necessary
to assure that instruments are maintaining their calibration Although Sr does not provide a truly
redundant system it does provide a means of assuring the constancy of the calibration system A ^Co
teletherapy machine can be use as part of a constancy system If only one dosimetry system isavailable, a redundant system should be formed with a dosimetry system at another institution withannual mtercompansons, if possible.

74

TABLE 11. QC OF^Co UNITS*
Adapted from AAPM TG-40.
Frequency

Procedure

Tolerance

Daily

SafetyDoor interlock

Functional

Radiation room monitor

Functional

Audio-visual monitor
Mechanical
LasersDistance indicator (ODI)

Functional
2 mm
2 mm

WeeklyCheck of source positioning

3 mmMonthly

Dosimetry
Output constancy
Mechanical checks
Light/radiation field coincidence
Field size indicator (colhmator setting)Gantry and colhmator angle indicator
Cross-hair centring
Latching of wedges, trays
Safety interlocks
Emergency off
Wedge interlocks

Annual

Dosimetry
Output constancy
Field size dependence of output constancy
Central axis dosimetry parameter constancy (PDD/TAR)
Transmission factor constancy for all standard accessories
Wedge transmission factor constancy
Timer linearity and error
Output constancy vs gantry angle
Beam uniformity vs gantry angle
Off axis points measurements with and without wedges
Safety Interlocks
Follow test procedures of manufacturers
Mechanical Checks
Colhmator rotation isocenter
Gantry rotation isocenter
Couch rotation isocenter
Coincidence of collim , gantry, couch axis with isocenter
Coincidence of radiation and mechanical isocenter
Table top sag with 80 kg mass evenly distnbuted
Vertical travel of table
Field-light intensity

2%
3 mm
2 mm
Ideg
2 mm
Functional
Functional
Functional
2%
2%
2%
2%
2%
1%
2%
3%
3%
Functional
2 mm diameter
3 mm diameter
2 mm diameter
2 mm diameter

2 mm diameter
5 mm
2 mm
Functional

All these procedures should be earned out during commissioning Appropriate tests should be performed following any repair of theteletherapy unit
The tolerance listed in the tables should be interpreted to mean that if a parameter either (I) exceeds the tabulated value (e g, themeasured isocenter under gantry rotation exceeds 2 mm diameter), or (2) that the change in the parameter exceeds the nominal value(e g the output changes by more than 2%), then an action is required The distinction is emphasized by the use of the term constancy

for the latter case Moreover for constancy, percent values are plus/minus the deviation of the parameter with respect to its nominal
value distances are referenced to the isocenler or nominal SSD (3)75TABLE III QUALITY CONTROL OF SIMULATORS
Adapted from AAPM TG-40
Frequency

Procedure

Tolerance

Daily

Localizing lasers
Distance indicator (ODI)

2 mm
2 mm

Monthly

Field size indicator
Gantry/collimator angle indicators
Cross-hair centering
Focal spot-axis indicator
Fluoroscopic image quality
Emergency/collision avoidanceLight/radiation field coincidence
Film processor sensitometry

2 mm
1 deg
2 mm
2 mm
Baseline
Functional
2 mm or 1%
Baseline

AnnualMechanical Checks

Colhmator rotation isocenter
Gantry rotation isocenter
Couch rotation isocenter
Coincidence of colhmator, gantry, couch axes and isocenter
Table top sag with 80 kg mass evenly distributed
Vertical travel of couchRadiographic Checks
Exposure rate
Table top exposure with fluoroscopy
kVp and mAs calibration
High and low contrast resolutiona

2 mm diameter
3 mm diameter
2 mm diameter
2 mm diameter
5 mm
2 mm
Baseline
Baseline
Baseline
Baseline

The tolerances mean that the parameter exceeds the tabulated value (e g the measured isocenter under gantry rotation exceeds 2 mmdiameter)76

TABLE I.III. QC OF MEASUREMENT EQUIPMENT/, initial use for each mode used or following malfunction and repairs; E, each use (measurement
sequence) or ongoing evaluation; B, each batch or box at appropriate energy (dosimeter element
position should also be considered); D, documented and correction applied or noted in report ofmeasurement; M, monthly. Adapted from AAPM TG-40.
Instrument type
Local standard

b

Test

Frequency

Tolerance

SSDL calibration
Linearity
Venting
Extra-cameral signal(stem
effect)

2yc
2yc
I

D
0.5%
D
0.5%

E
E
I
E

0.1%
2%
D
D

LeakageRedundancy check1*
Recombination
Collecting potential
Field instruments

2yC

Local std. comparison
Linearity
Venting
Extra-cameral signal
Leakage
Recombination
Collecting potential

2y
2y
2y
2y
E
I
E

Local std. comparison

M

Film

Linearity
Extra-cameral signal
Dose response
Densitometer linearity
Processor

ly
I
B
ly
E

D
1%
D
D
D

TLD

Calibration
Linearity

E
I

D
D

Thermometer calibration

I

0.1 deg/C

Barometer calibration

3 moLinear rule calibration

I

Imm/Hg0.3%

Output check
Relative dose
Ion chamber

1%
D

D
D
0.1%
D
D

Uniformity/reproducibility

Accessories

Percent values are plus/minus the deviation of the parameter with respect lo the nominal, and distances are referred to the isocenteror nominal SSD
Local standard instrument has a calibration directly traceable to an SSDL and should be reserved for calibration of radiation beams.
field instruments, and intercompansons.
Without a redundancy program, this may be inadequate
With a radionuclide (e g , '"Sr) or chamber mtercompanson771.6. THE QC OF TREATMENT PLANNING COMPUTERSThe treatment planning computer is a critical component of the entire treatment process.
Computers may be used to calculate patient dose distributions and treatment time or monitor units fora given prescribed dose and fixed point dose calculations for irregular fields, etc. All such systems
should undergo acceptance testing and commissioning. Following acceptance testing andcommissioning a QC programme should be implemented.
Complete documentation by the manufacturer should include the methods for obtaining thebeam data and other data necessary to implement the system. The manufacturer should provide acomplete description of the physical models for dose calculations with expected accuracy andlimitations along with complete input-output and operating instructions. QC tests should be performed
after program modifications and as part of an ongoing QC program. Table I.IV. lists the recommended
QC for treatment planning systems and treatment time calculations.

TABLE I.IV. QC FOR TREATMENT PLANNING SYSTEMS AND TREATMENT TIMECALCULATIONS
Reproduced with permission ofAAPM TG-40.

Frequency

Test

Tolerance

Commissioning and following
software update

Understand algorithm
Single field or source isodose distributions
Treatment time calculations
Test cases

Functional b
2%a or 2 mm
2%
2% or 2 mm

I/O system

1 mm

Daily

I/O devicesmmMonthly

Checksum
Subset of reference Quality Assurance testset (when checksums not available)

No change
2% or 2 mm

I/O system

1 mm

Treatment time calculations
Reference Quality Assurance test set
I/O system2%d2% or 2 mm
1 mm

Annual% difference between calculation of the computer treatment planning system and measurement (or independent calculation)
In the region of high dose gradients the distance between isodose lines is more appropriate than % difference In addition, less accuracy
may be obtained near the end of single sources
These limits refer to the comparison of dose calculations at commissioning to the same calculations subsequently
These limits refer to comparison of calculations with measurement in a water lank78

I 7 THE QC OF EXTERNAL BEAM TREATMENT PLANNING
In this section, QC for the treatment planning process is discussed, followed by a discussionof QC for individual patients QC in treatment planning may refer to two distinct processes (1) Nongraphical planning in which the treatment time for the prescribed dose to a point on the central axis iscalculated using central axis percent depth dose, tissue phantom ratios or tissue maximum ratios, andbeam output calibration tables Furthermore, the field apertures, which define the treatment volume,are usually designed on radiographs obtained dunng localization/simulation, (2) graphical planning isused for many patients In this method, a target volume is defined from CT or orthogonal simulation
films, and the patient's contour is either obtained using a mechanical device (e g, lead solder wire) orfrom CT The field arrangements are designed and dose distributions calculated on one or a limited
number of axial cross sections using a computerized treatment planning system The radiation
oncologist prescribes the dose and fractionation schedule

1.7.1. The QC of the Treatment Planning Process
Treatment planning is a process that begins with patient data acquisition and continues
through graphical planning, plan implementation and treatment verification It entails interactions
among the entire radiation oncology treatment team, and the use of a computenzed treatment planningsystem Each step of the complex treatment planning process involves a number of issues relevant toquality assurance The process is represented schematically in Table I V
TABLE I V TREATMENT PLANNING PROCESS
Reproduced with permission ofAAPM TG-40
Process

Related QC Procedures

Positioning and immobilization

Port films Laser alignment

Localization (simulation)

Simulator QC including image quality and mechanical integrity

Patient data acquisition(CT, MRI, manual contouring)CT, MRI QC including image quality and mechanicalintegrity (Accuracy of mechanical contouring)

Data transfer to treatment planning system

QC of the entire data transfer process, including digitizers,
digital data transfer, etc

Definmons of target volumes

Peer review, e g , new patient planning conference, chartroundsDesign of beam portals

Independent check of delivery (e g , port films) and peer review

Computation of dose distributions

Machine data from commissioning and QC of treatment
machines Accuracy and QC of treatment planning system

Plan evaluation

Peer review of plan, e g , dunng chart rounds Independent
check by a medical physicist

Prescription

Written, signed, and dated

Computation of monitor units

Treatment planning system QC Independent check within 48
hours

Production of blocks, beam modifiers

QC for block cutting and compensator systems Port film
review

Plan implementation

Review of set-up by treatment planning team Chart review

Patient Quality Assurance

Treatment plan review Chart review after new or modified
field, weekly chart review, port film review In-vivo dosimetry
for unusual fields, cntical organ doses (e g , gonadal dose)
Status check, follow-up

79

1.7.2 The QC of the Individual Treatment Planning Process

All parameters in the treatment plan should be verified dunng the first set-up so that any
ambiguities or problems can be corrected immediately Special care should be taken to assure that all
beam modifying devices (blocks, wedges, compensators) are correctly positioned Although errors inblock fabrication and mounting are often discovered dunng the review of port films, wedge orcompensator misalignment is much more insidious, and may remain throughout the course oftreatment if not discovered dunng initial patient set-up A check of the initial set-up by the physicist
will minimize errors that may be undetected due to misunderstanding of the physical concepts Details
of QC recommendations for individual patients are given in Table I VI
TABLE IVI SUMMARY OF QC RECOMMENDATIONS FOR INDIVIDUAL PATIENTS
Adapted from AAPM TG-40
Procedure

Recommendations

Treatment time calculation

Reviewed prior to treatment by an authorized individual who
did not perform initial calculation, or when not possible (e g ,emergency treatment), then prior to 3rd fraction or before 10%of the dose has been delivered, whichever occurs first

Graphical treatment plan review

1 Reviewed prior to treatment, or when not possible, thenprior to 3rd fraction or before 10% of the dose has beendelivered, whichever occurs first
2 Reviewed by a medical physicist who did not formulate
treatment plan Where only one physicist and that person
performed the plan, then reviewed by another authorizedindividual

3 Review includes calculated treatment time, input-output
and plan quality
4 Independent calculation of dose at a point Compare foreach field with an independent calculation of dose to apoint using the calculated monitor units - the prescnbed
and calculated dose
5 If these differ by more than 5%, then the discrepancy
should be resolved before continuing treatment
Plan set-up

Radiation oncologist present at first set-up for major changes intreatment

Beam (portal) films, curative and high morbidity
palliative treatment In addiuon, ongoing patients

Initial films reviewed by radiation oncologist pnor to first risk
portal films (the standard is weekly) also reviewed by theradiation oncologist

Beam (portal) films—palliative patients

Films reviewed prior to second fraction

In-vivo dosimetry

1 All institutions should have access to TLD or other m-vivo
dosimetry systems
2 Should be used to measure dose to cnucal structures (e g ,lens, gonads)
3 May be used to record dose for unusual treatment
conditions

80

1.8. USE OF IN-VIVO DOSIMETRY IN A QC PROGRAMME
In-vivo dosimetry can be used to identify major deviations in the delivery of treatment and toverify and document the dose to critical structures. Thermoluminescent dosimetry (TLD) is often usedbecause the device is small and relatively easy to calibrate, while diodes have the advantage of
instantaneous readout. These in-vivo systems can have relatively large uncertainties which should beassessed before using them. In-vivo systems are useful for individual patient measurements andshould be considered as part of a comprehensive QC programme.

1.9. CHART REVIEWA procedure for checking the patient charts for the technical parameters of treatment should
be developed. An outline of the parameters to be checked and verified is given below.
1.9.1. Review of New or Modified Treatment Fields

The first task of chart review is to find any errors. The following specific areas of the chart
should be reviewed:a) Treatment Prescriptionb) Treatment Parametersc) Isodose Distribution, Special Dose Calculationd) Treatment Timee) In-Vivo Measurementsf) Daily Recordg) Previous Radiation Treatments

1.9.2. Weekly Chart Reviewa)In addition to the initial chart check a weekly review should take place and should include:
Review of Treatments for Previous Weekb) Cumulative Dose
1.9.3. Review at Completion of Treatment

As a final review before the chart is placed in a file, the following items should be checked:a) Prescribed dose deliveredb) Chart properly documented according to department policyc) Treatment summary included81

I 10 THE QC PROGRAMME FOR BRACHYTHERAPY
The following lists the elements that should be in a quality control programme forbrachy therapy Further details can be found in the references listed at the end of this appendix

1.10.1. Sources
Recommended QC tests for brachytherapy sources are given in Table IVIITABLE I VII QC TESTS FOR BRACHYTHERAPY SOURCES/, Initial purchase, D, Documented, and E, at every use Reproduced with permission ofAAPM TG-40
Type of source

Test

Long half-life description

Physical/chemical form
Source encapsulation
Radionuchde distribution andsource uniformity
Location of Radionuchde
Means of batch
Deviation from mean
Calibration verification
Physical/chemical form

Long half-life calibration

short half-life description

Source encapsulation

Short half-life calibration

Mean of batch
Deviation from mean6

Frequency

Tolerance

I
I
I

D
D
D

I
I
I
E
I
I
E

1 mm
3%
5%,D
a

D
D
3%
5%

Radionuchde distribution andsource uniformity
Visual check of source color code or measurement in a calibrator

For short half life sources this may not always be practical
V visual check autoradiograph or lonometnc check110 1 1 Identification
For sealed sources large enough to carry identification numbers or coloured, labelled tapes,
check that the accompanying certificate detailing the serial number and the different characteristics ofthe source are in agreement with the number engraved on the source
For small sources that cannot be identified individually (examples 192Ir wires or seed ribbons),
check separately in a well lomzation chamber and store in special containers Every time the source iscut, it should be identified again and stored in another compartment

7 / 0 7 2 Inventor}
This should be carried out with each new delivery of sources and updated every time a change
occurs, in particular when sources are used for patient loading, it should be checked that they are
returned after patient treatment Moreover, a general source inventory should be earned out at least
every month A logbook or record of all sources present in the department and their location should beavailable at any time82

1.10.1.3. Contamination

The manufacturer should provide a certificate detailing the tests used to check the level ofcontamination of each source. Periodic tests should be performed to ensure that no degradation of thesources has occurred (swab test). Results should be recorded in a logbook.
1.10.1.4. Uniformity of linear activity

Autoradiography may be used to verify uniformity of linear activity. To obtain an acceptable
precision a low-sensitivity film must be used and read out with a densitometer. For ribbon sources
distances between sources should be verified. A linear activimeter is an alternate method of verifying
uniformity of linear activity.
1.10.1.5. Calibration

The use of the International System (SI) of units has been obligatory since 1985, and it isrecommended that the intensity of a source be specified in terms of air kerma rate. Total reference air
kerma rate can be measured by placing the radioactive source in the iso-response region of a well-typechamber previously calibrated by a Standards Laboratory with a source of the same geometricalcharacteristics. Particular attention should be taken when measuring HDR sources to assure that themeasurement range of the instrument is appropriate and the collection voltage is high enough toprevent significant recombination.
1.10.2. The QC of Applicators

QC tests should be performed before initial use, after repairs and periodically according toTable I.VIII.
TABLE I.VIII. QC TESTS FOR BRACHYTHERAPY APPLICATORS/, initial use or following malfunction and repairs; D, documented and correction applied or noted inreport of measurement, when appropriate; and E, as a minimum, a visual inspection to verify that thedummy sources fairly represent the active source distribution.
Reproduced with permission ofAAPM TG-40.

Type of applicator

Test

Frequency

Tolerance

Intracavitary

Source location
Coincidence of dummy andactive sources
Location of shields
Coincidence of dummy andactive sourcesI, yearly
I

D
1 mm

Ib
IJE

D

Interstitial

1 mm

To reduce personnel exposure, the dummy source location may be checked in place of the active source, if it is established that thedummy and active source locations are coincident

Location of shields should be verified by radiograph before the first use. Before every use, the applicator may be shaken to listen forloose parts

83

TABLE IIX QC OF REMOTE AFTERLOADING BRACHYTHERAPY UNITS
Reproduced with permission ofAAPM TG-40
Frequency

Test

Tolerance

Each treatment day

Room safety door interlocks, lights, and alarms
Console functions, switches, batteries, printer
Visual inspection of source guides

Functional
Functional
Free of kinks andfirmly attached
Autoradiograph

Verify accuracy of nbbon preparation
Accuracy of source and dummy loading (dummies
used for spacing and/or simulation/verification)
Source positioning

1 mm

At each source change orquarterly

Calibration1
Timer function
Check accuracy of source guides and connectors
Mechanical integrity of applicators (by X-ray if
appropriate)

3%
1%
1 mm
Functional

AnnualDose calculation algorithm (at least one standard
3%, 1 mmsource configuration for each isotope)
Simulate emergency conditions
Verify source inventory_______________________

Weeklya

1 mm

It is worthwhile at source change to calibrate both new and old sources to establish and document reproducibility of calibration method

TABLE I X QC TESTS FOR BRACHYTHERAPY SOURCE CALIBRATOR/, initial use or following malfunction and repairs", S, isotope/source specific, D, documented andcorrection applied or noted in report of measurement, when appropriate, and E, each use(measurement sequence) or ongoing evaluation Reproduced with permission ofAAPM TG-40
Instrument type

Test

Well lonization chamberStandards Laboratory calibration

I,Sa

D

Precision
Linearity
Collection Efficiency
Geometrical/length dependence
Energy dependence
Source wall dependence
Venting
Redundant check
LeakageI
I, 2 year
I
I
I
I
I
E
E

2%
1%
1%
D

SSDL calibration

I,Sa

D

Accuracy of source chamber
distance
Redundancy
See Table I III for other tests

lyr, S

1%, D

E

D

In-air calibration chamberand external source holder

Frequency

Instruments or sources must have a calibration directly traceable to a Standards Laboratory

84

Tolerance

D
D
D
2%
D

1.10.3. QC of Remote Afterloading Devices
Recommended QC tests for remote afterloading devices are given in Table I.IX.
It should be noted that in many countries the specification, performance and quality control ofafterloading devices may be mandated by government regulations. If this is the case then theseregulations must be adhered to. If they are different from the recommendations given in Table I.IX
then the table should be modified to reflect the appropriate regulations.

1.10.4. Measurement Equipment for Brachytherapy
I. J0.4.1. Well-Type lonization Chambers

QC procedures for well-type ionization chambers are given in Table I.X.

1.10.5. The QC of Brachytherapy Treatment Planning System
A systematic validation of both software and hardware is required, both before first use andafter any major revision. In any event full commissioning should be repeated annually to ensure thatno unintentional modifications have been introduced. A log should be kept of all tests, detailing themethods used and the results. General aspects of the quality control of treatment planning systems are
given in table I.IV.
1.10.5.1. QC Tests of Computer Software

Prior to data entry, peer reviewed literature relating to the method of calculation should be
identified and studied carefully, together with the system documentation. Where a commercial
software supplier offers a training course then a physicist from the local department should attend. If
the source specification quantity required by the computer system is different from that used forsource calibration then a detailed record should be made of the method of conversion and of allconversion factors used in the process.
Some tests of dose and dose rate computation and display algorithms that should be
performed include:a) Dose rates at points around a single source should be calculated at defined points relative to thesource and the results should then be compared to reference values and/or hand calculations. The
exact co-ordinates of the calculation points should be entered, and the results should not beinterpolated from a display grid or isodose display.
b) Isodose displays around a single source should be generated and compared to reference data .
c) Dose rate computations with multiple sources should also be performed. Multiple source testing
for linear sources should include a test with sources in different orientations: one possibility
would be to calculate the dose rate at the centre of a cube with sources arranged along the twelve
edges. It is recommended that a test case with multiple sources should be run monthly as part ofongoing quality control, together with a check sum test if this is available. The software should betested over the limits of its expected clinical usage and must not be used outside these limits
without further testing. If the software is to be used for dose calculations following, say, an
intracavitary cervix application then there should be a test using sources in a geometry typical of
local practice, and the results compared to dose rates determine by hand calculations.
d) Correction for source decay, when included in the software, should be compared to handcalculations.
e) The co-ordinate transformations and scaling involved in calculating doses and dose rates inarbitrary planes with magnification should be tested.
The above tests should be considered as examples. Other tests may be necessary at each
institution depending on the clinical practice.
85

1.10.6. QC of Patient Treatment Plan

Computer generated treatment planning for each individual patient should be checked withhand calculations of dose at selected points. Various graphs and tables from pertinent literature can beused for this purpose. This verification process can be facilitated with computerized spreadsheets. The
data used for the verification should be for sources identical to the ones being used clinically andpertain to sources specified in the same units. In particular, confusion between various source
specifications can lead to large errors in dose rate calculations.

86

Appendix J
RADIATION SHIELDING FOR EXTERNAL BEAM FACILITY
Figure J.I shows the plan and elevation views of a Cobalt 60 radiation therapy vault. Notethat the use of a maze allows for a rather standard door with only 3.2 mm of lead in the door. The
figure also shows that the room requires primary thick barriers on the walls and ceiling wherever the
Cobalt 60 beam may aim since there is no beamstop attached to this unit. If there were space below
the floor, then the floor would also be a very thick primary barrier. However, because of the weight of
the treatment unit an its shielding it is always best to put such a facility on unexcavated ground.
The method described in NCRP [5], for calculating the necessary shielding is based on threesteps:• establishing a dose value P at a given, occupied area,• estimating the dose, D, that would be received if no shielding were to be provided, and• obtaining the attenuation factor that is necessary to reduce D to P, e.g., finding the ratio D/P.
In [5], the dose value P was the regulatory individual dose limit. International
recommendation has recently shifted from the traditional method of accepting P as the regulatory
individual dose limit, to the optimization of protection by using a collective dose.
However, as optimization of protection based on the collective dose is complex and subject toa number of uncertainties, an accepted, more practical method is the constrained optimization, basedon establishing a (source related) individual dose constraint, which is set to be below the regulatory
dose limit.
The advantage of using individual rather than collective dose values is that the method is
simple and robust and that the NCRP [5] methodology can be applied, with the only difference of
replacing the individual dose limit by the in individual dose constraint.
The ratio of P/D is then the fractional attenuation which must be supplied by the barrier wall.
If the barrier material such as concrete has a known tenth-value-layer thickness, TVL (in cm), then thewall thickness can be determined from the equation:(P/D) = 10E-( thickness/TVL)J.I DETERMINATION OF P
The constraint could be assumed to be '/i of the individual dose limit related to the source (theteletherapy unit). Since the dose is uniformly distributed throughout the year, the weekly dose
constraint for occupational exposure could be 10/50=0.2 mSv, corresponding to an ambient dose
equivalent of H*(d)=0.2 mSv/week.
For members of the public, the dose constraint would be 1/50*2=0.0 ImSv/week.

J.2 DETERMINATION OF D
Direct beam (calculation of primary barrier):

The weekly workload (W) is obtained: the dose delivered to a patient at the isocenter (usually
80 cm) is multiplied by (80/100)2 and by the number treatments per week, i.e., number of patients/day,

multiplied by 5 days/week.
Therefore, as an example, if 40 patients/day are to be treated with 2 Gy/patient, 5 days/week,
thus the workload at the isocenter is W=400 Gy/week There are actually three components to the dosevalue D
This dose value can be modified by the Use Factor (U) for the barrier (the fraction of thework performed with the beam directed to the barrier in question) and by the Occupancy Factor (T)for the position in question, which represents how much time during the treatment week mightsomeone be present. The modified dose is WUT.

87

The dose rate of the beam at one meter from the source, is converted to the dose at theposition in question by using the inverse of the square of the distance from the isocenter of thetreatment unit, e.g., the primary dose

D = WUT/d 2(1)

Leakage radiation:
There is the leakage radiation from the head of the unit (D|) which is given as the percent of
the primary dose rate (%1). Since leakage radiation is not a beam but a radiation field, the use factor is
U=l
The leakage dose isD, = WT(%l/100)/d 2(2)

Scattered radiation:
There is the radiation which is scattered to the position, mainly from the patient (DJ which is
given by the scatter fraction (a).
The scatter dose is

Ds = WT(a)/d 2(3)Note that both the leakage and the scatter components are also decreased by the square of the
distance from the isocenter.
Combination of the three types of radiation:
If there can be a primary beam directed to the position then that will be the greatest thickness
by far and that should be the design thickness for the barrier. If there is no primary beam at thebarrier, then use the bigger of the leakage or scatter thickness if one is bigger than the other by at least
one TVL, otherwise use the bigger value and add 0.333 TVL.
The use factor can only be less than 1 for the primary barriers since the barriers always haveleakage and scatter striking them when the beam is on.

J.3 EXAMPLE OF CALCULATION OF PRIMARY BARRIER
From figure J.I, if the point A is taken as the control console for the machine, the dose
constraint would be P=0.1 mSv/wk. Since this is a primary barrier the use factor U may be less than 1;
assuming U=0.25, i.e., the beam strikes the barrier only 1A of the "beam on" time. The operator isalways at the console when the beam is on so the occupancy T = 1. The unattenuated dose per week at
A is given by decreasing W by the square of the distance from the isocenter and by the use andoccupancy factors: U and T.
Dp = WUT/(dA)2 = 400*0.25*802/(120+160+80)2 = 5 Gy/week
Therefore, the primary barrier must attenuate the fraction 5/0.0001=50,000log (50,000)=4.69 TVL

If the TVL of concrete is 20.6 cm for concrete with 2.35 gm/cc. Therefor a thickness of 96.6
cm. A barrier of 100 cm would be used

J.4 EXAMPLE OF SECONDARY BARRIER
J.4.1 Leakage radiation
P = 0.01 mSv/wk as a dose constraint for members of the public (the ambient dose equivalent of 1 Svcorresponds numerically to 1 Gy absorbed dose for Co-60 at the dose maximum)
W = 400 Gy/week
U = 1 for all secondary barriers

T = 0.1 for an area occupied all the timedi = 200+60 cm% leakage = 0.05 % for the cobalt heada = 0.0009 for scatter
The barrier required by leakage is then given by eq (2)D, = (400*0.05/100)/2.62 = 0.03Gy/wk
and D/P= 0.03/0.00001 = 3,000
Therefore we need 3.4 TVL's or about 72 cm of concrete.

J.4.2 Example of secondary barrier for scatter radiation
Ds = 400*0.00097 (2.6)2 = 0.052 Gy/week
and Ds/P = 0.052/ 0.00001=5,200

J.43 Combination of leakage and scatter radiation
This indicates the need for 3.72 TVL's but one must remember that the energy of scatteredradiation is greatly reduced from the primary beam energy and is usually about 0.5 MeV which has a
TVL of 11.7 cm of concrete so 3.72 TVL's is 43.5 cm of concrete. Since this is more than one TVL
smaller than the leakage requirement one can just use the thickness required for leakage radiation, i.e.,
72cm.
Remark:It should be noted that there is a conceptual difference between using the dose limits for P andusing dose constraints. The use of dose limits for P was made in combination with conservative
factors, such as W, U, T, which provided a safety margin leading to actual doses that were well below
the limits, often 1/10 of the dose limit. The use of dose constraints is a step toward optimization(constrained optimization). Therefore, the safety margins should be reduced, since a safety margin isalready incorporated in the constraint. Conceptually, optimization should be used with realistic rather
than overestimated factors. Using conservative factors together with constraints goes beyond
optimization, i.e., it is "not optimized".
A typical conceptual error is to re-evaluate existing shielding, using dose constraints keeping
conservative factors, thus ignoring that the actual doses were 1/10 of the calculated ones or evenlower, e.g., ignoring existing safety margins. The result may be an increased barrier thickness, that is
not necessary, nor it is optimized and can not be considered as a good practice of protection.

89

OS

091

OZV

06

OB

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IAEA, Vienna (1987).
INTERNATIONAL ATOMIC ENERGY AGENCY, The use of plane-parallel ionizationchambers in high energy electron and photon beams. An International Code of Practice for
Dosimetry, Technical Reports Series No. 381, IAEA, Vienna (1997).
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EUROPEAN SOCIETY FOR THERAPEUTIC RADIOLOGY AND ONCOLOGY, Quality
assurance in radiotherapy, Radiother. Oncol. 35 (1995) 61-73.
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Radiation Protection for Medical and Allied Health Personnel, NCRP 105, NCRP, Bethesda,
MD(1989).
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INTERNATIONAL ELECTROTECHNICAL COMMISSION, Medical Electrical
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sources - General, ISO-1677-1977, ISO, Geneva, (1977).
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION, Sealed radioactive
sources - Leakage test methods, ISO/TR 4826, ISO, Geneva, (1979).
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CONTRIBUTORS TO DRAFTING AND REVIEW
Aguilar, V.

International Atomic Energy Agency

Almond, P.

James Graham. Brown Cancer Center, USA

Andreo, P.

International Atomic Energy Agency

Baeza, M.

Institute de Radiomedicina, Chile

Ezzell, G. A.

Harper Hospital and Wayne State University, USA

Habjouqa, A.

International Atomic Energy Agency

Horton, J.

M.D. Anderson Cancer Center, USA

Hudson, A.

National Radiation Protection Board, UK

Izewska, J.

International Atomic Energy Agency

Kamel, R.

International Atomic Energy Agency

Levin, V.

International Atomic Energy Agency

Llamas, A.

International Atomic Energy Agency

Liniecki, J.

Medical University of Lodz, Poland

Marinello, G.

Hopital Henri Mendor, France

Matscheko, G.

International Atomic Energy Agency

Mattsson, O.

Shalgren University Hospital, Sweden

Meghzifene, A.

International Atomic Energy Agency

Moller, T.

Southern Swedish Regional Tumour Registry, Sweden

Mukuna, B.

International Atomic Energy Agency

Oresegun, M.

International Atomic Energy Agency

Ortiz-Lopez, P.

International Atomic Energy Agency

Rodriguez, P.

MedTec Galicia, Spain

Shanta, A.

International Atomic Energy Agency

Stovall, M.

M.D. Anderson Cancer Center, USA

Tolli, H.

International Atomic Energy Agency

Viser, A.

Academic Hospital Rotterdam, The Netherlands

Volodin, V.

World Health Organization

Wilkinson, J.

Christie Hospital, UK

Williamson, J. F.

Mallinckrodt Institute of Radiology, USA

93

Consultants Meetings
Vienna, 22-24 May 1995, 11-15 December 1995, 3-7 June 1996,
20-25 October 1997, 8-12 December 1997, 4-8 May 1998

Advisory Group Meeting
Vienna, 9-12 December 1996

94

RECENT IAEA PUBLICATIONS ON CLINICAL, MEDICAL PHYSICS,
RADIATION PROTECTION AND SAFETY ASPECTS OF RADIOTHERAPY

1994 Measurement Assurance in Dosimetry (Proceeding Series - STI/PUB/930)
1994 Radiation Dose in Radiotherapy from Prescription to Delivery,
Proceedings of an IAEA Seminar in Leuven (IAEA-TECDOC-734)
1995 Calibration of Dosimeters Used in Radiotherapy (Technical Reports Series No. 374)

1996 Radiation Dose in Radiotherapy from Prescription to Delivery,
Proceedings of an IAEA Seminar in Rio de Janeiro (IAEA-TECDOC-896)
1996 Review of Data and Methods Recommended in the International Code of Practice,Technical Reports Series No. 277 for Absorbed Dose Determination in Photon andElectron Beams. (IAEA-TECDOC-897)
1996 FAO/IAEA/ILO/OECD(NEA)/PAHO/WHO, International Basic Safety Standards forProtection against Ionizing Radiation and for the Safety of Radiation Sources, Safety
Series No. 115

1997 The Use of Plane-Parallel lonization Chambers in High-Energy Electron and Photon
Beams. An International Code of Practice for Dosimetry. (Technical Reports Series
No. 381)1997 Absorbed Dose Determination in Photon and Electron Beams: An International Code ofPractice (Technical Reports Series No. 277, 2nd edition)
1997 Quality Assurance in Radiotherapy (IAEA-TECDOC-989)
1997 IAEA/ESTRO Monitor Unit Calculation for High-Energy Photon Beams.
ESTRO Physics for Clinical Radiotherapy, Booklet No. 3 (Garant Publ., Leuven)

1998 The Accidental Overexposure of Radiotherapy Patients in San Jose, Costa Rica (Special
Publication Series, STI/PUB/1027)95