radiation oncology practice standards part b guidelines v2

RADIATION ONCOLOGY PRACTICE STANDARDS

Part B: Guidelines

RANZCR ASMIRT ACPSEM CNSA NZCNC

Part B presents guidelines in support of the 16 fundamental standards (Part A) developed

for radiation oncology practices. It should be read in conjunction with the 16 standards.

The Tripartite Committee, formed in 1998, is a peak group in Radiation Oncology representing the three key professions involved in radiation therapy:

• The Royal Australian and New Zealand College of Radiologists (RANZCR), Faculty of Radiation Oncology (FRO),

• Australian Society of Medical Imaging and Radiation Therapy (ASMIRT).

• The Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM). In 2019 the Tripartite Committee was replaced by the Radiation Oncology Alliance with the inclusion of radiation oncology nurses supported by the Cancer Nurses Society of Australia (CNSA). The main objectives of the Alliance are:

• To represent a key forum for collaboration between the radiation therapy professions in the areas of quality, standards, workforce and public interest.

• To act as an important liaison point for the Department of Health, and its committees and working groups.

• To communicate key sector priorities to the Government and to the public.

• To maintain good communication between FRO, ASMIRT, ACPSEM, CNSA. The Royal Australian and New Zealand College of Radiologists, the Faculty of Radiation Oncology, Australian Society of Medical Imaging and Radiation Therapy (formerly, Australian Institute of Radiography) and the Australasian College of Physical Scientists and Engineers in Medicine, received Australian Government funding support for the development and publication of the original Radiation Oncology Practice Standards and Supplementary Guide.

Radiation Oncology Practice Standards Part B: Guidelines Version 2, 2017

Tripartite Standards Working Group Page i

TABLE OF CONTENTS

INTRODUCTION................................................................................................................................ 1 BACKGROUND ............................................................................................................................................. 1 THE CURRENT SITUATION ..................................................................................................................... 2

SCOPE................................................................................................................................................... 3

ACRONYMS AND ABBREVIATIONS ............................................................................................ 4

STANDARDS ....................................................................................................................................... 5 FACILITY MANAGEMENT......................................................................................................................... 5 STANDARD 1—STAFF .............................................................................................................................. 5 STANDARD 2—WORKFORCE PROFILE .............................................................................................. 8 STANDARD 3—MANAGEMENT OF RADIATION ONCOLOGY PATIENT RECORDS ................ 9 STANDARD 4—DATA MANAGEMENT ............................................................................................... 11 STANDARD 5—FACILITY INFRASTRUCTURE ................................................................................ 13 STANDARD 6—FACILITY PROCESS MANAGEMENT ..................................................................... 16 STANDARD 7—RADIATION THERAPY EQUIPMENT.................................................................... 18 TREATMENT PLANNING AND DELIVERY ......................................................................................... 21 STANDARD 8—THE RADIATION THERAPY TREATMENT PRESCRIPTION .......................... 21 STANDARD 9—PLANNING PROCEDURES ........................................................................................ 23 STANDARD 10—DOSIMETRY .............................................................................................................. 27 STANDARD 11—RADIATION THERAPY TREATMENT DELIVERY........................................... 30 SAFETY AND QUALITY MANAGEMENT ............................................................................................. 33 STANDARD 12—SAFETY, QUALITY AND IMPROVEMENT PROCESSES ................................. 33 STANDARD 13—RADIATION SAFETY ............................................................................................... 36 STANDARD 14—INCIDENT MONITORING PROGRAM ................................................................. 39 STANDARD 15—DOSIMETRIC INTERCOMPARISON .................................................................... 40 STANDARD 16 — CLINICAL TRIALS AND EVIDENCE BASED PRACTICE ............................... 41

DEFINITIONS ................................................................................................................................... 45

REFERENCES .................................................................................................................................... 48

Radiation Oncology Practice Standards Part B: Guidelines

RO Practice Standards Working Group Page 1

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INTRODUCTION 1

BACKGROUND 2

In 2002 the report A Vision for Radiotherapy by Professor Peter Baume [1] identified a number 3

of national safety and quality issues relating to radiation oncology. The Radiation Oncology 4

Jurisdictional Implementation Group (ROJIG) was established to develop a response to the 5

Baume enquiry. In 2003 it produced a report recommending the development of a quality 6

program to be implemented as a priority. The Radiation Oncology Reform Implementation 7

Committee (RORIC) was then established and tasked with the development and 8

implementation of a quality program. The Quality Working Group was set up as a sub-9

committee of RORIC. It identified the need for profession agreed practice standards as a key 10

component of a quality system. 11

12

The main professionals providing radiation therapy treatment are radiation oncologists, 13

radiation therapists and radiation oncology medical physicists. These professions are 14

represented by the following organisations within the Tripartite Committee: 15

• Royal Australian and New Zealand College of Radiologists (RANZCR), Faculty of 16

Radiation Oncology (FRO) 17

• Australian Society of Medical Imaging and Radiation Therapy (ASMIRT) 18

• Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) 19

In 2019 the Tripartite recognised the contribution of radiation oncology nurses (RON) to patient 20

care and changed the name of the group to the Radiation Oncology Alliance, thereby including 21

RONs as part of the professional groups. Th current review of the Radiation Oncology Practice 22

Standards (ROPS) has provided an opportunity to incorporate the Radiation Oncology Nursing 23

Practice Principles into the ROPS. 24

• The nursing organisations involved are: 25

o Cancer Nurses Society of Australia (CNSA) 26

o New Zealand Cancer Nurses College (NZCNC) 27

28

Nominees from these professional bodies constitute the Alliance. 29

30

The Tripartite Committee—funded by the then Department of Health and Ageing (DoHA) 31

through RANZCR—commenced work to develop radiation oncology practice standards. Draft 32

Standards were developed and reviewed by the Tripartite Committee along with numerous 33

volunteers from the three professions and submitted to DoHA in early 2007. These Standards 34

were edited by members of the professions in consultation with quality standards experts 35

(Tripartite Standards Working Group) under the auspices of the Tripartite Committee. The 36

resultant 16 basic Standards were published in draft form as Radiation Oncology Practice 37

Standards in 2008. DoHA and the professions believed it to be essential to pilot the 38

acceptance of and ability to implement these standards. A number of public and private 39

facilities volunteered to trial them. The National Association of Testing Authorities (NATA) was 40

contracted to assist the facilities with the trial and to provide feedback to the Tripartite 41

Committee and to the Quality Working Group. 42

43

The use of the Radiation Oncology Practice Standards—Part A: Fundamentals is likely to 44



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underpin reform in the sector. 45

46

THE CURRENT SITUATION 47

As mentioned above, the 16 Standards were distilled from the original draft standards that 48

were presented to DoHA in 2007. The latter were extremely detailed and expansive and have 49

undergone fine-tuning by members of the editing group with review by the three professions 50

culminating in this document. It is anticipated that radiation oncology facilities, in particular 51

new facilities, will find it a valuable resource supporting the Radiation Oncology Practice 52

Standards—Part A: Fundamentals thereby assisting in the provision of safe and effective 53

radiation therapy to oncology patients. 54 55



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SCOPE 56

57

The Radiation Oncology Practice Standards—Part A: Fundamentals and Part B: Guidelines 58

are considered to be essential to the delivery of safe quality care to radiation oncology 59

patients; as such, both documents should be read together. This document provides additional 60

essential material in support of the Standards and should be used to complement them. The 61

two documents are linked by identical headings and descriptors for each individual standard 62

and criterion. As the Standards are interrelated inevitably there will be some duplication both 63

within and between the two documents. 64

65

The Standards are compliant with the Australian Commission on Safety and Quality in 66

Healthcare National Safety and Quality Health Service Standards.[2] 67

68 69



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ACRONYMS AND ABBREVIATIONS 70

71 AAPM American Association of Physicists in Medicine ACHS Australian Council on Healthcare Standards ACPSEM Australasian College of Physical Scientists and Engineers in

Medicine ACSQHC Australian Commission on Safety and Quality in Health Care ARPANSA Australian Radiation Protection and Nuclear Safety Agency ASMIRT Australian Society of Medical Imaging and Radiation Therapy AS/NZS Australian Standard / New Zealand Standard CNSA CTV

Cancer Nursing Society of Australia Clinical target volume

DH Department of Health, United Kingdom DICOM Digital Imaging and Communications in Medicine DoH Department of Health (formerly Department of Health and Ageing)

ESTRO European Society for Therapeutic Radiation Oncology FRO Faculty of Radiation Oncology, the Royal Australian and New

Zealand College of Radiologists GTV Gross tumour volume IAEA International Atomic Energy Agency ICRP International Commission on Radiological Protection ICRU International Commission on Radiation Units and Measurements IMRT Intensity modulated radiation therapy IPEM Institute of Physics and Engineering in Medicine ISO International Organisation for Standardisation MLC Multileaf collimator MU Monitor units NCCI National Cancer Control Initiative NHS National Health Service, United Kingdom NZCNC PTV

New Zealand Cancer Nurses College Planning target volume.

QA Quality assurance RANZCR Royal Australian and New Zealand College of Radiologists RCR Royal College of Radiologists RO Radiation oncologist ROJIG Radiation Oncology Jurisdictional Implementation Group ROMP Radiation oncology medical physicist RON RORIC

Radiation oncology nurse Radiation Oncology Reform Implementation Committee

RSO Radiation safety officer RT Radiation therapist TROG Trans-Tasman Radiation Oncology Group WH&S Work health and safety

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STANDARDS 73

FACILITY MANAGEMENT 74

STANDARD 1—STAFF 75

Staff competence is ensured by recruitment and selection procedures and maintained 76

by staff development and a performance review system. 77

78

CRITERION 1.1 79

There are registers of current registration/licence to practise for all applicable staff. 80

81

SUPPLEMENTARY COMMENTARY 82

All Radiation Oncologists (ROs), Radiation Therapists (RTs), Radiation Oncology Medical 83

Physicists (ROMPs) and Radiation Oncology Nurses (RON) are appropriately qualified and 84

maintain their eligibility to their professional associations and meet requirements of regulatory 85

bodies. 86

87

Staff members who work with ionising radiation or radioactive substances in states with 88

radiation licensing may be required to record induction and continuing radiation safety training. 89

Practitioners in other states are monitored by their state registration board or radiation safety 90

committee. 91

92

A competency is defined as proficiency, ability or a skill set based on a complex range of 93

knowledge, skills and attitudes.[3] Clinical competencies will develop from “learning in 94

context”.[4] 95

96

Advances in radiation oncology technology and its application in clinical practice require on-97

going training and education programs.[5] Training in clinical centres forms a significant 98

component of qualification and professional accreditation as an RO, ROMP and RT. 99

100

ROs achieve Fellowship through training at facilities accredited by the Royal Australian and 101

New Zealand College of Radiologists (RANZCR) and supervised by the RANZCR Radiation 102

Oncology Education and Training Committee.[6] Overseas trained specialists who wish to have 103

their specialist medical qualifications recognised in Australia initially apply to the Australian 104

Medical Council for registration to practise as ROs. Both an assessment of their training and 105

experience and a formal examination conducted under the auspices of the RANZCR are 106

required prior to their eligibility for recognition as a specialist in radiation oncology and for 107

Fellowship of the College.[6] 108

109

RTs must complete either an undergraduate degree or a graduate entry degree from an 110

accredited university. In both streams, radiation therapists are required to meet AHPRA’'s 111

professional capabilities for registration, to ensure they are safe and competent practitioners. 112

Following graduation both groups are then also eligible for recommendation for a 'Statement 113

of Accreditation' from the Australian Society of Medical Imaging and Radiation Therapy 114

(ASMIRT) [7] 115

To practice in Australia under protected titles, Radiation Therapist’s must be registered with 116



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the Medical Radiation Practice Board of Australia under the National Registration and 117

Accreditation Scheme (the National Scheme). Resumption of Professional Practice 118

candidates and overseas graduates with qualifications from institutions with programs that 119

have not been approved by ASMIRT must undertake an Assessment of Qualifications gained 120

outside Australia in Radiation Therapy, to demonstrate skills and knowledge of modern 121

radiation therapy practice including technology applications and treatment techniques. A 122

Statement of Qualification will be granted and a letter for use in the immigration process 123

issued. [8] 124

125

ROMPs are medical physicists who are registered with the Australasian College of Physical 126

Scientists and Engineers in Medicine (ACPSEM) on the ACPSEM Qualified Medical Physics 127

Specialists (QMPS) Register in Radiation Oncology, or who have an equivalent level of 128

training, skills, knowledge and expertise to a person on the register as determined by a 129

relevant authority. To gain registration a medical physicist needs to be awarded certification 130

in radiation oncology by the ACPSEM Radiation Oncology Certification Panel or be 131

determined by the panel that they have achieved an equivalent level of competency. Medical 132

physicists achieve certification through the ACPSEM either by successful completion of 133

ACPSEM Training, Education and Assessment Program (TEAP), or through an assessment 134

of them having completed a program equivalent to the TEAP that may include the requirement 135

for additional training and education to match the TEAP standards. For a medical physicist to 136

maintain their registration with the ACPSEM they are required to abide by the ACPSEM Code 137

of Ethics and to undertake continuous professional development. 138

RONs are registered or enrolled nurses who provide comprehensive, holistic, high-quality 139 radiation oncology nursing care for patients as part of the cancer continuum. RONs are 140 accredited annually through the Australian Health Practitioners Regulation Agency (AHPRA) 141 for Nursing and Midwifery attaining the mandatory registration requirements of the agency and 142 Board. RONs work in a radiation therapy setting, have specialist knowledge and skills related 143 to radiation oncology, and identify as a radiation oncology nurse. Radiation oncology nurses 144 support departmental issues of safety and quality care, and work within the mandatory and 145 legislative requirements of the role. 146

147

CRITERION 1.2 148

Performance review systems supported by staff development programs are in place and 149

current. 150

151


A professional development program at each facility is recommended for all staff. In addition, 153

performance review can have a significant effect on skill development and practice.[9] 154

155

The range of competencies required in radiation therapy treatment can be divided into three 156

areas: clinical expertise, risk management and professional responsibilities. 157

158

The competencies needed by medical specialists include the roles of medical expert, clinical 159

decision maker, communicator, collaborator, health advocate, manager, scholar and 160

professional.[10] 161



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Radiation Therapist’s competencies involve Professional Practice, Communication, Clinical 162

Knowledge and Application, Critical Thinking and Quality Assurance Evaluation, Safe Delivery 163

and Clinical Management, as well as, Lifelong Learning [8]. 164

The ROMP competencies span across all aspects of dosimetry in the areas of radiation 165

therapy equipment commissioning, accuracy, reliability and quality assurance, radiology 166

physics and radiation safety and emerging technologies related to medical physics and 167

biomedical engineering. RON competencies are determined by the local authority and also 168

include clinical decision maker, communicator, collaborator, patient advocate, manager, 169

scholar and professional. 170

171

To support these competencies, participation in education and continuing professional 172

development (CPD) is recommended. Continuing education (CE) is shown to improve 173

theknowledge, skills and behaviour of health professionals as well as enhancing patient health 174

outcomes. CE is most effective when it is ongoing, interactive, and contextually relevant and 175

based on needs assessment.[11] The supervision of staff is enhanced when mentorship is 176

provided by staff with skills and training as an educator.[12]. Interprofessional education relating 177

to common issues is a recognised mode of learning with and from professional colleagues 178

where teamwork and collaboration are important competencies.[13] 179

To reduce adverse clinical incidents, staffing levels and non-clinical time for training and 180

development should be reviewed regularly to take account of the facility’s current workload, 181

research and development activities, maintenance of quality systems and pressures 182

associated with commissioning new equipment or systems.[14] 183

184

Participation in CPD is mandatory for AHPRA registration and/or registration with the New 185

Zealand MRTB. 186

187

The ACPSEM provides a CPD register for its members to facilitate professional responsibilities 188

in maintaining professional standards of practice. 189

190

SUPPLEMENTARY EVIDENCE 191

• Staff members have documented current position descriptions that describe their 192

required skills and knowledge. 193

• Documentation of orientation provided for all new staff. 194

• There is a CPD policy that describes the support for participation in continuing 195

professional development such as in-house programs, mentorship, study leave, 196

conferences and workshops and evidence to prove the CPD policy is being used. 197

• Access to other facilities for training is available where relevant. 198

• Staff members responsible for the education, training and supervision of fellow 199

colleagues have access to further instruction and support. 200

201

202

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STANDARD 2—WORKFORCE PROFILE 204

The workforce is managed to ensure delivery of safe quality care. 205

206

CRITERION 2.1 207

Staffing numbers are established to safely meet planned patient care capacity. 208

209


The mix of skill and experience within the workforce should be evaluated and managed 211

according to service, safety and quality objectives and facility operation. 212

213

Health care systems that have similar resource levels to Australia provide points of reference 214

for workforce profiles for ROs, RTs and ROMPs.[16-22]. 215

216

Expert clinician narratives acknowledge that best staffing principles for RONs is to 217

assign a nurse to the same patients as an RO under the line management of a nurse 218

Manager, advanced practice nurse and/or nurse educator. Further nursing resources will 219

include specialty resources such as gamma knife, brachytherapy, paediatrics and research, 220

and evening shifts.[23] 221

222

CRITERION 2.2 223

Rosters and schedules incorporate time for non-direct patient care activities applicable to the 224

facility’s service delivery profile. 225

226


Rosters and scheduling should be considered in terms of the availability of skilled and 228

experienced staff. Rostering should facilitate skill development, maintenance and continuing 229

education with the support of management through the provision of financial and non-financial 230

resources. 231

232


• There is a protocol that describes the process and frequency for workforce evaluation 234

and management activities consistent with the recommendations of the respective 235

professional bodies. 236

• Data are collected and monitored to support workforce planning. 237

• Records of financial and non-financial support provided to allow staff to participate in 238

non-direct patient care activities. 239

• There are policies to facilitate recruitment and retention of skilled staff and evidence to 240

show the success of the policies. 241

• There is a system for managing the availability of staff, whether directly employed by the 242

facility or providing services under contractual arrangements. 243

• Rosters show protected non-patient care time is available to assist all staff to undertake 244

continuing education. 245

246

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STANDARD 3—MANAGEMENT OF RADIATION ONCOLOGY PATIENT RECORDS 248

Management of the radiation oncology patient record supports safe, quality care. 249

250

CRITERION 3.1 251

The radiation oncology patient record is the primary, comprehensive source of information for 252

the delivery of patient care within the radiation therapy department and complies with 253

jurisdictional legislation. 254

255


Records, administrative and recording practices are structured to provide a relevant, accurate 257

and retrievable description of the patient’s progress through their treatment. Records may be 258

a composite of paper and electronic systems. Information relevant to patient care from other 259

sources should be available to staff within the department - ideally by incorporating into the 260

patient record. 261

262

The precise detail, timing and location of any previous and current radiation treatment, 263

including site, technique, verification procedures, delivered dose and number of fractions 264

should be obtained and clearly recorded in the individual patient health record. 265

266

Staff responsible for radiation treatment of an individual patient should be identified in the 267

radiation treatment record. 268

269

CRITERION 3.2 270

The radiation oncology patient record and databases containing patient information are 271

logged, secure, accessible by authorised personnel only and are retained according to 272

jurisdictional requirements. 273

274


The individual patient health record should be structured to allow sufficient access to 276

necessary information by all health professionals involved in providing care. 277

278

Data have a role as a clinical and legal record and as a planning tool. Information relating to 279

a patient’s treatment is important for evaluating outcomes and can affect future treatment for 280

that patient. 281

282

Records should be stored securely and the data retrievable through explicit privacy and 283

confidentiality procedures. 284

285

Record-keepers in possession or control of a record that contains personal information must 286

ensure that it is protected by security safeguards against theft, loss, unauthorised access, use, 287

modifications or disclosures, and against other misuse. 288

289

Facilities should plan and design systems such that the duration of storage complies with 290

jurisdictional requirements. The ability to retrieve electronic information at a later date will 291

require additional planning in relation to upgrade and obsolescence of any electronic systems. 292



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293


• The patient ID is recorded on each page of the treatment chart, whether paper or 295

electronic format. 296

• Specific treatment related data are recorded at each treatment session, including the 297

identity of at least two (2) accredited persons delivering treatment. 298

• There is a policy defining the levels of physical and electronic restriction of access to 299

facility records. 300

• There are documented procedures for storage of electronic information when systems 301

are upgraded or changed. (Examples include the ability to access information from 302

previous electronic systems, and the existence of a DICOM archive for radiation therapy 303

images, plans and dose distributions.) 304

• Tenders relating to the upgrade or replacement of system components that hold 305

electronic data include specifications for comprehensive data migration to ensure that 306

previous data is still accessible. 307

308

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STANDARD 4—DATA MANAGEMENT 310

The management of data supports clinical activities and reporting requirements. 311

312

CRITERION 4.1 313

The management of clinical data is planned, systematic and supports clinical audit, clinical 314

trials, outcomes analysis and existing cancer registry requirements. 315

316


Data items and definitions should be based on national data dictionaries to facilitate 318

comparisons of outcomes, choices and treatment. There is agreement in principle between 319

Australian jurisdictions to adopt a nationwide core clinical data set and dictionary.[22] In any 320

radiation oncology facility, the data to be collected will need to consider the requirements of a 321

national data set as well as those of other reporting bodies. For example, professional bodies 322

and statutory authorities require monitoring and audit of specific aspects of radiation therapy 323

practice for quality assurance activities. 324

325

In each facility and jurisdiction there is a wide variety of stakeholders with differing data 326

requirements. These may include clinicians, administrators and research groups and it is 327

useful to consult these groups when planning or reviewing data collection.[22,23] 328

329

Strategic planning for data collection should include a multidisciplinary data management 330

team led by an appointed data custodian. Understanding user needs is imperative to maintain 331

the relevance and accuracy of data and ongoing support for its collection.[25,26] Periodic audit 332

of databases helps to ensure data integrity and improve patient management and organisation 333

planning. Reporting the outcomes of data audits can improve staff communication, 334

professional satisfaction and confidence in data collection activities. Any resulting 335

improvements in data quality and integrity are then likely to contribute to improved 336

management of cancer patients.[14,25] 337

338

CRITERION 4.2 339

Disease/diagnosis and staging data conform to recognised classification systems in 340

accordance with facility policies. 341

342


Data collections within radiation oncology facilities are used for the assessment of care of 344

patients, health policy development, clinical research, clinical improvement and health service 345

provision so it is important that the data are accurate and current.[25-28] 346

347

Accurate reporting of cancer incidence, cancer management, facility activities and treatment 348

outcomes are dependent on reliable and comprehensive data.[25,28,30] Accordingly, data 349

collection processes need to consider the reliability of data sources and timeliness of data 350

entry.[33-35] 351

352

The accuracy of data collection and data transcription depends on appropriate training for staff 353

in current data collection practices and recognised classification systems. 354



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355

CRITERION 4.3 356

There is a facility-agreed minimum data set used for each patient that meets the facility’s 357

clinical decision making and reporting responsibilities. 358

359


Epidemiological research relies upon verifiable source data.[28] 361

362

Data collected should be sufficient to allow care delivery to be tracked, monitored and 363

evaluated. Provision of training in data entry, adequate staffing levels and resources are 364

important to achieve compliance.[25,28,30] 365

366

Monitoring demographic trends in cancer incidence, clinical practice trends and clinical 367

outcomes may assist in forward planning for resources, facilities and infrastructure. 368

369


• Toxicity detail provided by clinicians is consistent with the definitions specified in the 371

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events 372

(CTCAE v5.0) or a recognised equivalent. 373

• There is an appointed data custodian who has responsibility for the control and security 374

of data collection and accuracy of entry. 375

• The data management plan should address: 376

o consistency and continuity between electronic and paper records; 377

o accountabilities; 378

o data collection; 379

o data storage needs of the organisation at all levels; 380

o timeliness of data entry; 381

o date stamping of events; and 382

o management of events that are not date-stamped. 383

• The data management plan should include guidelines for ROs, RTs and ROMPs and 384

RONs about the format of data provision and entry. 385

• There are scheduled reviews of the needs of staff for data resources, particularly with 386

respect to identifying deficits, the use of available resources and prioritising strategies for 387

improvement. 388

• There is a policy relating to facility response to data requests from professional and 389

statutory bodies for identified clinical indicators. 390

391

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STANDARD 5—FACILITY INFRASTRUCTURE 393

The facility infrastructure promotes safe quality care and accountability in the delivery 394

of radiation treatment services. 395

396

CRITERION 5.1 397

The strategic planning process addresses the operational and physical organisation of the 398

facility and takes account of changing needs. 399

400


A rational estimate of the number of megavoltage treatment units required is dependent on a 402

number of factors. These include: the proportion of patients with given cancer type with 403

indication for radiation therapy treatment; the incidence of these cancer types; radiation re-404

treatment rates; and the machine throughput in terms of number of treatment courses per year 405

for a linear accelerator. 406

407

Long term planning and investment is needed; to train the highly specialised staff required to 408

prescribe, plan and deliver radiation therapy, provide treatment units and equipment and build 409

the facilities for them.[31] 410

411

The facility’s strategic plan should consider: 412

• the patient pathway; 413

• communication and information systems; 414

• measurement, quality assurance (QA) and quality improvement (QI) programs and 415

process control systems; 416

• waste management; 417

• emergency and disaster management; 418

• security and safety management; 419

• risk, incident and complaints management; 420

• Work Health and Safety (WHS); 421

• processes for addressing codes of ethics, conduct; 422

• processes for strategic alignment with local environmental needs, state and national 423

directives, benchmarks or guidelines; 424

• processes for assessing, evaluating, and adapting to emergent technologies and 425

techniques; and 426

• resources, financial, accounting, governance, and asset processes.[32] 427

428

The process of strategic planning should also identify when, where and how to provide allied 429

health services, as access to these services and care is essential to the delivery of quality 430

radiation therapy services.[33] 431

432

Staff involvement is crucial to organisational success. A participative culture involving all 433

stakeholders, including patients and consumers will encourage individuals to work together in 434

adapting and meeting new challenges, reshaping work patterns and redesigning job roles.[34] 435

436

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CRITERION 5.2 438

Facility management and performance are based on a multidisciplinary approach to ensure 439

accountability and safety in the delivery of radiation treatment services. 440

441


Operational infrastructure design addresses: resources, reward systems, physical work 443

environment and job design; staff training and development; staff well-being; processes for 444

monitoring and managing change; and processes for ensuring alignment with the overall 445

strategic design.[32] 446

447

The most important component in safe practice is qualified personnel. The safe and efficient 448

operation of each item of equipment requires equipment system specific training.[35] 449

450

Radiation therapy requires a multidisciplinary approach to the justification, adoption and 451

implementation of new processes, technologies and techniques, as changes in the operational 452

design and performance in one area may increase or decrease workloads in others. 453

454

Clearly defined leadership and organisational arrangements help ensure radiation therapy 455

services are of a high quality.[27] 456

457

CRITERION 5.3 458

The physical infrastructure and environment including patient, staff and public amenities are 459

designed, managed and maintained to support safe practice in the delivery of radiation 460

therapy. 461

462


The physical infrastructure and environment of facilities must reflect their strategic objectives 464

and operational infrastructure. These are important safety and quality considerations in facility 465

design. 466

467

The facility should employ staff or contracted services with appropriate qualifications in room 468

design, shielding and radiation safety. 469

470

The functional performance specifications for all equipment need to meet local requirements 471

and relevant standards, and any deviations identified, documented and justified.[35-38] 472

473

Life-cycle management includes upgrade and replacement planning, failure contingency 474

planning, repairs, modifications, maintenance and calibration programs, service and 475

operations logbook systems.[39] Adherence to manufacturer’s specifications for life-span limits 476

on equipment and systems will also ensure patient and staff safety and continuity of service. 477

478

The facility should comply with radiation protection legislation, including shielding 479

requirements and equipment. When designing radiation shielding for a treatment room, factors 480

that need to be considered include: workload of the equipment and the way it will be used; 481

and the intended use and occupancy of adjacent rooms. 482

483



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When purchasing new or replacement equipment, radiation protection requirements for 484

shielding design, interlocks, control rooms etc should be considered. All differences should be 485

identified, and any additional works specified by qualified expert(s), and included in the 486

equipment purchase process. These would include changes in external beam energy; for 487

example, by replacement of cobalt unit with linear accelerator of higher beam energy, requiring 488

additional bunker shielding; installation of HDR unit and required control area and interlock 489

systems. 490

491

The IAEA [40] stipulates the requirements for dedicated ‘hot laboratories’ for the use of unsealed 492

sources. This includes the provisions for storage, shielding fume cupboards and support 493

services. 494

495

The IAEA [40] states that any modifications to building design subsequent to initial approval will 496

be subject to a new approval process. 497

498

The IAEA [40] states that relevant areas in the facility should be classified as controlled or 499

supervised when specific protection measures and safety procedures are needed to control 500

normal exposure and to prevent potential exposure. 501

502


• The facility, its services and amenities are easily located, suitably signposted and have 504

access for the disabled. 505

• Annual workloads and equipment performance, including comparisons to published and 506

local benchmarks, are measured, monitored and documented. 507

• There is a structured system of communication and reporting processes across the 508

facility. 509

• Records of the life-cycle management for all equipment and systems (maintenance 510

programs, upgrade paths, end-of-life projections, replacement programs) are maintained. 511

• Records of resource allocation (financial, personnel, time) for systems commissioning 512

and implementation; support equipment and accessories to meet optimal QA, safety, 513

dosimetry and calibration requirements are maintained. 514

• Records of shielding designs, calculations for radiation therapy equipment and details of 515

measurements to verify shielding designs are maintained. 516

517

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STANDARD 6—FACILITY PROCESS MANAGEMENT 519

The provision of radiation therapy treatment services is timely, coordinated and 520

equitable to ensure optimal patient outcomes. 521

522

CRITERION 6.1 523

The patient pathway is co-ordinated to provide optimal patient outcomes within available 524

resources. 525

526


A patient’s progress through a care facility is often referred to as the patient pathway. Fully 528

understanding this pathway by mapping the processes is a key element for organising patient 529

flow; ensuring that diagnosis, referral, treatment planning, treatment delivery, supplementary 530

care and review are as efficient and patient-friendly as possible. 531

532

Other factors may impact on facility process management, for example staffing and equipment 533

resources. Monitoring and benchmarking suitable indicators will highlight issues that need 534

addressing. 535

536

CRITERION 6.2 537

Care is provided in a timely manner according to patient need. 538

539


Waiting time is one indicator of quality of care. It is defined as “the time elapsed between the 541

radiation oncologist’s decision that treatment should commence (ready for care) to the first 542

treatment being delivered”. That decision is influenced by post-operative healing phase, post-543

chemotherapy recovery phase, patient requested delay, time for treatment of intercurrent 544

morbidities that make the patient unfit to start treatment and any other delay beyond the control 545

of the facility. These delays should be separately recorded.[41,42] 546

547

Clinical need and resource availability affect waiting list management. Undue delay, treatment 548

interruption and unplanned treatment prolongation may result in adverse clinical outcomes 549

and/or patient harm, reduction in patient satisfaction, negative impact on relatives and carers, 550

negative impact on staff morale and increased demand for labour resources. 551

552

The Board of the Faculty of Clinical Oncology[43] list the five major causes of unscheduled 553

interruptions to radical radiation therapy: 554

• machine and staff availability; 555

• public holidays/statutory days; 556

• patient transport problems; 557

• medical problems; and 558

• social circumstances that lead to a patient’s failure to attend for treatment as scheduled. 559

560

Measures to address delay, treatment interruption or prolongation include: 561

• adjusted working hours (but this practice is not recommended as a long-term solution);[42] 562

• provision and maintenance of adequate resources; 563



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• avoidance of the adverse effects of prolonged breaks over public holidays by appropriate 564

treatment scheduling; 565

• planned scheduling of machine downtime to avoid treatment interruptions; and 566

• compensation measures, including: 567

o twice daily fractionation, minimum six-hour interval; 568

o weekend treatment; 569

o use of biologically equivalent dose in fewer fractions to achieve planned overall 570

time, where risks of normal tissue complication allow; and 571

o additional fractions where compensation cannot be achieved within the original 572

planned time.[44] 573

574

Benchmarking through the regular monitoring of equipment capacity helps identify future 575

planning and resource needs.[42,45] 576

577


• There is a written protocol that describes the principles of the patient pathway. 579

• Minutes and records from multidisciplinary team meetings that address the patient 580

pathway and facility needs. 581

• There is a protocol for prioritising patients based on clinical need. 582

• Data on process indicators are provided to authorised organisations on request to allow 583

benchmarking against other facilities. 584

• Audits of compliance with patient pathway policies and protocols. 585

• There is a policy for the transfer of patients to other facilities when treatment is extended, 586

machine downtime or when patients cannot be accommodated in the facility. 587

• There are reporting mechanisms adhering to nationally agreed standards enabling 588

comparisons of waiting times. 589

590

591



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STANDARD 7—RADIATION THERAPY EQUIPMENT 592

Radiation therapy equipment performs to specifications that ensure accurate and safe 593

clinical treatment. 594

595

CRITERION 7.1 596

Qualified, trained and experienced staff specify requirements of new radiation therapy 597

equipment. 598

599


All radiation therapy equipment including software supports the clinical application, safety and 601

accuracy of treatment planning and delivery. 602

603

The acquisition of new radiation therapy equipment should follow a needs analysis with input 604

from a multidisciplinary team. 605

606

Compliance to relevant Australian and New Zealand Standards encompasses environmental 607

conditions, protection against abnormal operation and fault conditions including electric shock 608

hazards and mechanical hazards, as well as protection against hazards from unwanted or 609

excessive radiation, and the accuracy of operating data. 610

611

It is the responsibility of the manufacturer to provide all relevant documentation for equipment 612

function and maintenance. 613

614

CRITERION 7.2 615

New radiation therapy equipment, and any modification to same, is installed, acceptance 616

tested and commissioned for clinical use by qualified personnel. To ensure accurate and safe 617

clinical usage, any newly commissioned equipment requires independent dosimetry 618

intercomparison. 619

620


The equipment commissioning and QA records constitute the primary sources of information 622

to support the accuracy and safety of radiation delivery. 623

624

It is essential that installation of equipment—or modification to existing equipment—is 625

performed only by suitably trained staff. Before modifications are made to existing equipment, 626

staff should consult the manufacturer to establish if the planned modifications will affect 627

performance of the equipment. 628

629

Acceptance testing is done to ensure that equipment performs to the specifications agreed in 630

the purchase contract. Qualified staff should perform acceptance testing in conjunction with 631

the manufacturer or their agent. Where particular local needs have been identified in the 632

purchasing process, these should be tested with reference to the specified requirements. The 633

warranty period commences when the equipment is accepted. 634

635

Data obtained during acceptance testing provides the information on which to base decision 636



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about the life-cycle of the equipment. 637

638

Equipment commissioning can be divided into three phases—verification of adherence to 639

specifications, data acquisition and beam modelling. The baseline information obtained during 640

this process provides the foundation for the future QA program. 641

642

It is essential to include software in all QA considerations. All changes to software should be 643

subject to stringent acceptance, commissioning and QA checks as for initial commissioning. 644

645

Software changes from manufacturers may be mandatory, to fix a known problem, or may be 646

elective; for example, to acquire increased functionality. In advance of proposed changes, 647

release notes should be obtained from the manufacturers and the scope of the changes and 648

implications for clinical use discussed with them. 649

650

Any software change should be scheduled to minimise disruption to clinical treatments, and 651

to allow sufficient time for checking and QA before release for clinical use. Some checking 652

programs are extensive, such as treatment planning system upgrades to the software. 653

654

All staff using software should be trained. 655

656

If any of the specifications are not met, it is essential the vendor, all affected staff and the 657

regulatory authority (where applicable) be notified. 658

659

CRITERION 7.3 660

There is a preventative maintenance program for radiation therapy equipment that ensures 661

safety, reliability, reproducibility and accuracy. 662

663


The functional performance of radiation therapy equipment may be affected by breakdown, 665

ageing or deterioration of any component. The output, laser checks and isocentre of the 666

treatment machine need to be verified daily. 667

668

Maintenance may be carried out by the manufacturer’s representative, or by in-house staff 669

who are trained and qualified. 670

671

CRITERION 7.4 672

There is a quality assurance (QA) program to assess the ongoing performance of all radiation 673

therapy equipment used in treatment planning and delivery. 674

675


Equipment commissioning and QA records provide evidence that all radiation therapy devices, 677

both software and hardware, are maintained and monitored to ensure that the accuracy of 678

dose delivery and imaging meets national and international standards. These provide the 679

basis of an audit trail. 680

681

QA procedures may involve all members of the multidisciplinary team, depending on the 682



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equipment. These processes may be managed by a QA committee and should be approached 683

from an organisational viewpoint and not be patient specific. 684

685

ROMPs are responsible for withdrawal of or restrictions to clinical use of equipment, when 686

performance does not comply with stated baselines and tolerances or is not fit for clinical 687

purpose as determined by the multidisciplinary team.[45] After any upgrade or modification of 688

equipment by the manufacturer, the ROMP is responsible for ensuring appropriate checks are 689

performed [46] and QA procedures put in place. 690

691

All staff performing equipment QA procedures must be trained and be familiar with local 692

practices. The QA committee is responsible for local guidelines on the introduction of new 693

equipment or techniques. 694

695

The QA program should have planned periodic reviews—and should also be reviewed 696

consequent to the publication of new or revised national or international guidelines—to ensure 697

that it continues to cover all aspects of treatment techniques in use. 698

699


• There are guidelines to describe the procedure for determining equipment specification. 701

These guidelines include advice on ensuring compliance with statutory regulation and 702

safety requirements. These guidelines address occupational health and safety, clinical 703

requirements and training needs. 704

• There is a documented strategy for the purchase and replacement of equipment, which 705

includes consideration of budgetary measures. 706

• User manuals and equipment documentation and/or specification are available including 707

notifications and alerts from manufacturers. The method of dissemination of this material 708

to all users is defined. 709

• Vendor equipment documentation demonstrates that equipment requirements comply 710

with Australian and New Zealand Standards. 711

• Records are maintained as documented evidence of equipment and safety training, and 712

evidence is provided that these are reviewed prior to staff/operator rotation on to 713

equipment. 714

• Registration documents are available in accordance with appropriate legislation. 715

• Logs of all service reports are maintained for both planned and corrective maintenance 716

activities. Service reports contain detailed information on work completed and the 717

performance of equipment with reference to manufacturer’s specifications. 718

• All staff and contractors who perform maintenance work on equipment have appropriate 719

training and qualifications and can be identified. 720

721

722



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TREATMENT PLANNING AND DELIVERY 723

STANDARD 8—THE RADIATION THERAPY TREATMENT PRESCRIPTION 724

The radiation therapy treatment prescription documents the intended course of 725

treatment for the individual patient. 726

727

CRITERION 8.1 728

Patients are informed of the benefits and risks of the proposed radiation therapy treatment 729

and their consent is documented by the consenting clinician. 730

731


Informed decision-making is an important component of high quality health care. 733

Patients are entitled to make their own decisions about whether to undergo proposed radiation 734

therapy treatment and need information to make these decisions.[47] The information should 735

be provided in a format and manner that helps patients understand their diagnosis and the 736

proposed radiation treatment. Patient involvement in the development of written information 737

makes it more relevant, easier to read and more understandable, without increasing their 738

anxiety.[53] It needs to be appropriate to the patient’s circumstances, personality, expectations, 739

fears, beliefs, values and cultural background.[49] 740

741

Written information is a source of information that complements the information provided 742

verbally by the consulting radiation oncologist. Written information should be offered to 743

patients rather than expecting them to find it.[39] This should include information that is 744

anatomical-site specific and information about radiation therapy treatment issues in general, 745

including the use of permanent skin marks. 746

747

Information should describe the potential side effects for each individual patient. Advice for 748

dealing with and managing side effects should also be included and there should be an 749

identified point of contact for patient queries. 750

751

Written information for patients should be evidence based and reviewed regularly to ensure it 752

remains current.[50] 753

754

It is important to tailor written information to the local population, which includes providing it in 755

the major languages spoken within the area. 756

757

CRITERION 8.2 758

The radiation therapy treatment prescription conforms to legislation, licensing regulations, 759

policies and clinical protocols and guidelines. 760

761


The radiation therapy treatment prescription is the primary source of information for the 763

planning and delivery of safe radiation therapy treatment and documents the intended course 764

of treatment. 765

766

Data items essential to prescribing radiation therapy treatment are documented in the radiation 767



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therapy treatment prescription by the radiation oncologist. The use of consistent and common 768

datasets and terminology known by all staff enables the prescribed treatment to be accurately 769

interpreted. 770

771

The use of prescription templates is common practice in Australia. Templates may be pre-772

printed prescription sheets or in electronic form. Their use enables all prescriptions for 773

radiation treatment within a facility to conform to a common format and provide consistent 774

information. 775

776

National and international disease-related protocols and treatment guidelines are useful 777

evidence-based tools that contribute to consistency in the prescribing of treatment. 778

779

Reports from the International Commission on Radiation Units and Measurements [56-61] 780

provide recommendations for the prescribing, recording, and reporting of radiation therapy 781

treatment. Use of these internationally recognised guidelines allows comparison between 782

facilities, and is often mandated in clinical trials. 783

784

CRITERION 8.3 785

Radiation therapy treatment prescriptions are regularly audited by peer review. 786

787


There is evidence that ongoing audits of treatment contribute to the continuing quality 789

improvement of radiation therapy practice and staff education.[4,9] 790

791


• The staff education program includes the principles of informed consent and their 793

application. 794

• There is a procedure for involvement of professional interpreter services. 795

• Evidence-based written information, including the potential side effects, is available to 796

patients about anatomical-site specific treatment and radiation therapy treatment issues. 797

• Information for patients is written in the main languages spoken in the local population 798

and contains contact details for patient queries. 799

• Written information for patients is regularly reviewed and includes input from patients. 800

• There is a policy that states the requirements and definitions to be used for prescribing 801

radiation therapy treatment. 802

• Nationally and internationally endorsed disease-related protocols for the prescription of 803

radiation therapy treatment are available. 804

• There is a documented policy for the conduct of radiation therapy treatment prescription 805

audits that describes: 806

o the frequency of audits; 807

o the number of records to be audited; 808

o the personnel to be involved in the audit; and 809

o the reporting requirements after the audit; for example, compliance with 810

protocols. 811

812



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STANDARD 9—PLANNING PROCEDURES 813

Comprehensive, safe and consistent planning procedures promote optimal treatment 814

outcomes. 815

816

CRITERION 9.1 817

Treatment planning protocols are documented, accessible to staff and endorse evidence-818

based best practice. If there is no clinical protocol available for the procedure/treatment, as far 819

as possible, the procedure/treatment should follow the best available protocol. 820

821


Uniformity of treatment planning protocols is desirable so as to enable evaluation of treatment 823

outcome. Regular auditing of treatment planning protocols is an important quality assurance 824

initiative.[62,63] 825

826

Treatment planning protocols encompass: patient positioning, immobilisation and monitoring, 827

simulation and imaging, contouring and target definition, suggested beam positioning, plan 828

development and evaluation. 829

830

The contouring procedure, which encompasses the treatment voluming process, delineates 831

all relevant regions of interest including, external contour, gross tumour volume (GTV) or 832

clinical target volume (CTV) or planning target volume (PTV), organs at risk (OAR), air cavities, 833

bolus, artifacts and fiducial markers, using manual and/or computer-assisted methods. [55, 57, 834 56, 59] Uniformity can be improved by adopting standardised nomeclatue. 835

836

Quantitative data displays encompassing dose statistics, dose volume histograms and 837

biological modelling—tumour control probability (TCP) and normal tissue complication 838

probability (NTCP)—can be utilised to obtain quantitative information about an isodose 839

distribution.[60,61] 840

841

Checking the record of radiation therapy treatment—including the developed, evaluated and 842

approved isodose plan—before a patient commences treatment, minimises the risk of 843

planning-induced treatment errors.[62] 844

845

Treatment planning system software requires a comprehensive quality control procedure to 846

ensure that the plan development and evaluation are accurate.[37,59,63-66] 847

848

CRITERION 9.2 849

External and internal immobilisation methods and equipment are fit for purpose. 850

851


A comfortable, stable and reproducible patient position is essential for the delivery of 853

consistent and accurate radiation therapy and can be achieved using an immobilisation 854

device/method.[37,59, 63-70] 855

856

All staff who use immobilisation devices should have relevant technical knowledge, and be 857



Version 3, 2021

aware of the usefulness, limitation/s and application of each immobilisation device. 858

859

All immobilisation devices should undergo a risk assessment and comprehensive clinical 860

evaluation—including the effect on dose delivery—so that both patient safety and treatment 861

outcomes are not compromised.[47, 68,71-73] 862

863

To determine the most appropriate immobilisation device for each patient and promote optimal 864

treatment outcomes it is essential to consider the principles of stability and reproducibility, 865

comfort, individual needs, organ motion and the complexity of the proposed radiation therapy 866

technique.[74-78] 867

868

The optimal treatment position is achieved and reproducibility errors are minimised by 869

comprehensive documentation that itemises patient immobilisation and set-up details.[62,79-81] 870

871

Every personalised immobilisation device should be labelled to avoid incorrect use.[6] It is 872

important to check that the correct device is used for each patient and there is visual 873

verification by a second person. 874

875

It is necessary that all patients requiring an internal immobilisation method are given adequate 876

instructions to maximise stability and reproducibility of patient position, as well as ensuring 877

patient safety.[74] 878

879

Where external immobilisation devices restrain patients, it is essential to have an action plan 880

for rapid release to minimise patient distress.[63] 881

882

Access to mould room facilities is required for the manufacture of custom immobilisation 883

devices and additional treatment requirements 884

Any immobilisation devices that are reused at a later date on another patient must have clear 885

infection control measures in place. 886

887

Other items that may be used every day on the same patient must have specific cleaning, 888

storing and infection control measures in place. 889

890

CRITERION 9.3 891

Planning and imaging procedures localise, delineate and define target volumes and organs at 892

risk, as well as enabling treatment verification. 893

894


The pre-simulation process is important to promote accuracy and efficiency.[59,68] Timely 896

information for patients helps reduce anxiety, increases willingness to comply with treatment, 897

and promotes reproducibility of patient position.[69,70,82] 898

899

Patient position and immobilisation is determined at simulation. The simulation procedure 900

combines the planning imaging process with the technical and clinical planning process. 901

902

Ensuring patient privacy, dignity and comfort is essential at all times. 903



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904

Implementing an infection control policy minimises the harm that can arise from the 905

transmission of health care associated infections, thereby ensuring patient and staff safety, 906

and improving quality of care.[83,84] 907

908

Virtual simulation permits the radiation oncologist and radiation therapist to access a 909

computed tomography (CT) data set to define a volume, treatment field and the isocentre. 910

911

Pre-treatment verification allows the radiation oncologist and radiation therapist to evaluate 912

the feasibility of a proposed treatment plan, acquire verification images or re-evaluate a 913

previously defined treatment field.[68] 914

915

Planning and imaging equipment should be compatible with other equipment used in the 916

facility to enable accurate and timely communication of digital images. 917

918

The dose a patient receives while undergoing planning and imaging procedures should be ‘as 919

low as reasonably achievable’ (ALARA) to promote patient safety. 920

921

Comprehensive and accurate labelling of all planning images ensures image data can be used 922

for quality improvement, education and research activities, and also as an important quality 923

assurance procedure to minimise reproducibility errors and avoid incorrect use.[41,62,89] 924

925

All planning images and planning data need to be durable, confidential, stored securely and 926

easily accessible. 927

928

Nursing Practice Principle 1: Care delivery is tailored to the specific needs and preferences 929

of each individual. Refer to Appendix A. 930

931

Definition: Patient centred care is the provision of care that is respectful of, and responsive 932 to, individual patient preferences, needs and values; ensuring that patient values guide all 933 clinical decisions.[1] 934 935 Nursing Practice Principle 3: The information and education needs of patients and their 936

carers are identified and met. Refer to Appendix A. 937

938


• Records from multidisciplinary working parties established to develop treatment planning 940

protocols for new techniques. 941

• All treatment planning procedures including imaging, contouring (manual or computer-942

assisted) and target definition are documented in the patient’s record. 943

• Treatment planning protocols are accessible in designated work areas used by ROs, 944

RTs and ROMPs. 945

• There is a policy for the review of treatment planning protocols. 946

• There is a policy for checking the accuracy of all volumes, including manual contours, 947

3D-generated volumes, automatically rendered volumes and interpolated volumes. 948

• Treatment plans and isodose distributions are compliant with treatment protocols. 949



Version 3, 2021

• The chosen immobilisation device, with settings where applicable and patient set-up 950

information are accurately documented and verified by another staff member during 951

simulation. 952

• Procedures are monitored and evaluated to ensure that all data required for simulation, 953

including images are requested, collated and reviewed prior to the patient’s simulation 954

appointment. 955

• There is a documented policy for checking of all simulation data. 956

• Verbal and written information explaining simulation and treatment is given to all patients 957

prior to the simulation procedure. 958

• There are instructions available for patients on how to signal for help if they experience 959

distress during the planning procedure. 960

• Documented quality assurance activities that monitor, evaluate and address: 961

o image quality, including issues of noise, distortion, artefacts, contrast, resolution, 962

compression and reconstruction; 963

o image communication and integrity, including the conformance of planning 964

equipment with DICOM; and 965

o image systems, including transfer between hardware and software systems. 966

• There is a policy that describes the best practice procedures for imaging each region of 967

the body in relation to the: size of the imaged area or upper and lower scanning levels; 968

type of views imaged per technique or the thickness of slices; and the standard 969

exposures or recommended settings. 970

971

972



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STANDARD 10—DOSIMETRY 973

A dosimetry system, consistent with national and/or international standards, ensures 974

the safety and accuracy of the prescribed radiation dose for all clinical treatments. 975

976

CRITERION 10.1 977

Dose measurement ensures compliance of the dose delivery with the treatment prescription. 978

979


Accurate dosimetry can only be attained by strictly following a specific protocol that defines 981

the method and appropriate correction factors to determine absorbed does at the reference 982

point (formalism). In Australia dosimetry formalism is determined by the Australasian College 983

of Physical Scientists and Engineers in Medicine (ACPSEM).[67] 984

985

ROMPs are responsible for the calibration of dosimetry equipment and must ensure that it is 986

fit for the purpose of accurately measuring dose. 987

988

CRITERION 10.2 989

The calibration of the radiation dose delivered by all clinical treatment units is consistent with 990

dosimetry codes of practice recommended by national regulatory authorities. 991

992


Accuracy in the dose delivery of treatment equipment is verified through periodic independent 994

dosimetry audit.[86] 995

996

Treatment delivery equipment must be calibrated using dosimetry equipment with calibrations 997

traceable to the national dose standard kept by a national standards laboratory. [59,63,87] 998

999

CRITERION 10.3 1000

A system for the calculation of dose distributions in the patient ensures that all doses can be 1001

directly related to the absolute dose determined for the treatment equipment under reference 1002

conditions. 1003

1004


The purpose of the treatment planning data must be identified, as well as the date of issue, 1006

document name and number. The data must have clear guidance for its use and its limitations 1007

specified.[37,67,86] 1008

1009

For purpose of audit, the data sources must be traceable with details of measurement 1010

conditions.[86,87] Inaugural data collection at new treatment units should be verified with 1011

relevant published reference data as endorsed by the ACPSEM.[67] 1012

1013

For purposes of ongoing quality assurance, all dosimetry data should be saved as reference 1014

data in a suitable format [67] and all superseded data must be withdrawn from clinical use to 1015

prevent accidental use of outdated data. 1016

1017



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CRITERION 10.4 1018

Calculation of monitor units (MU), exposure times or dwell times required to deliver each 1019

prescribed dose are independently checked. 1020

1021


Treatment planning systems (TPS) and independent dose calculations systems should be 1023

commissioned according to international best practice and national ACPSEM 1024

recommendations.[67,85,88] 1025

1026

All calculations of dose to a patient must be independently checked by a second authorised 1027

RT or ROMP before treatment is delivered. This check should be performed using an 1028

independent dosimetry system to verify the calculation process and that the appropriate 1029

dosimetry data have been applied. Software or processes to perform the monitor unit check 1030

calculation should be independent of the primary calculation; for example, software and 1031

machine data files should not be shared in the calculations. 1032

1033

If there are changes to the treatment plan or monitor units, any new calculated dosimetric 1034

data, including monitor units are to be subject to the same calculation and checking processes 1035

as the initial calculation process. 1036

1037

To verify the entire dose calculation chain, the dosimetry for any new treatment delivery 1038

equipment, TPS (including changes to algorithms) and new treatment technique should be 1039

verified by a ROMP by dose measurement in a phantom before clinical implementation.[67,89,90] 1040

1041

CRITERION 10.5 1042

There is a system for independent verification of dose delivery to individual patients. 1043

1044


In-vivo dosimetry should be used to verify new methods of dose calculations, including new 1046

treatment planning systems; new treatment techniques or modalities, when new beam 1047

modifiers are introduced; and to assess dose to critical organs or structures.[89-91] 1048

1049

The ROMP is responsible for establishing and maintaining the accuracy of in-vivo dosimeters 1050

according to ACPSEM recommendations and/or international recommendations, where 1051

appropriate. 1052

1053

In-vivo dosimeters may perturb the incident radiation beam, which means that the effect of the 1054

in-vivo dosimeter on the dose distribution should be assessed by a ROMP and approved by 1055

the prescribing RO. 1056

1057

CRITERION 10.6 1058

For SBRT/SRS treatments where CTV to PTV margins are a small and geometric accuracy is 1059 critically important, a system shall be in place to ensure that the required geometric accuracy 1060 is routinely achievable. 1061 1062



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Typically an end-to-end test with the capability to test the geometrical accuracy of the entire 1064 treatment chain combined with an audit of patient immobilisation would satisfy this 1065 requirement. The Australian Clinical Dosimetry Service includes a suitable end-to-end test in 1066 their stereotactic level III audits. 1067 1068


• There is documentation that dosimetry equipment is checked at least at the frequency 1070

recommended by the ACPSEM. 1071

• Documentation of actions taken to re-calibrate equipment following independent and 1072

internal audit processes. 1073

• Documented systems for control of all data used in patient dose calculations are 1074

available. 1075

• There are documented pre-defined or set action levels to determine if independent dose 1076

calculations are outside tolerance limits. 1077

• There is access to in-vivo dosimetry equipment for patient dose monitoring. 1078

• The procedure for in-vivo dosimetry is based on national and international 1079

recommendations. 1080

• Patient in-vivo dosimetry records or reports are available as part of the medical record of 1081

treatment. 1082

• There is documentation to demonstrate that the geometrical integrity of the treatment 1083

chain in check in its entirety at least annually, and individual components more 1084

frequently.[92] 1085

1086

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STANDARD 11—RADIATION THERAPY TREATMENT DELIVERY 1088

Treatment is delivered correctly, accurately, safely and consistently with due 1089

consideration of the patient’s rights and responsibilities. 1090

1091

CRITERION 11.1 1092

Verification procedures are used that minimise the risk of incorrect patient, incorrect dose and 1093

anatomical treatment misplacement. 1094

1095


It is important to treat a patient with the correct treatment to the correct site otherwise a 1097

misadministration occurs. The National Safety and Quality Health Service Standards, 1098

standard 5 (Patient Identification, A) requires “At least three approved patient identifiers are 1099

used when providing care, therapy or services”.[2] 1100

1101

The site to be treated should be verified daily with the patient. This may be done by: asking 1102

the patient to state the site (including laterality) to be treated; using a photograph of the 1103

treatment site or field marks; or using an anatomical diagram displaying the location of 1104

treatment fields. 1105

1106

Patient confidentiality should be protected in the identification process. 1107

1108

Accredited or credentialed persons delivering the first treatment should use more than one 1109

source of information to crosscheck data in the electronic record and verify (RV) system; for 1110

example, treatment plan, patient’s health record, set-up, and isocentre heights. Regular 1111

checks of the RV system should be undertaken to monitor the integrity of these data. 1112

1113

Any changes to treatment should be recorded in the patient’s treatment chart or electronic 1114

record with the identification of the person making the change and the recorded date of the 1115

changes. 1116

1117

A position verification process is used to monitor patient positional differences and 1118

uncertainties and facilitate accurate treatment delivery through the adoption of appropriate 1119

action levels and clearly specified interventions. The frequency of verification images depends 1120

on the site treated, treatment intent, the immobilisation device used, an individual patient’s 1121

condition and the intended degree of reproducibility sought. 1122

1123

Checks of the source/focus to surface distance (SSD/FSD) before the first treatment and at 1124

regular intervals verify that the patient geometry is as expected in the treatment plan. They 1125

also detect changes in patient shape over time; for example, due to weight loss. Day to day 1126

variations in patient set up are likely to be random and smaller in magnitude than first day 1127

variations. Other influences in positioning accuracy include disease change and modification 1128

to set up or shielding. 1129

1130

Verification of the treatment isocentre and field position is done prior to the first treatment and 1131

re-evaluated at regular intervals during the course of treatment. This may be done by 1132



Version 3, 2021

comparing it to the digitally reconstructed radiograph (DRR), CBCT or other localisation 1133

methods such as fiducial markers. 1134

1135

Orthovoltage, superficial x-ray and electron treatments should have the field position verified 1136

visually at the treatment unit at the time of each treatment to decrease the incidence of field 1137

placement errors. 1138

1139

CRITERION 11.2 1140

Patients are observed during radiation delivery and monitored according to need. 1141

1142


A visual monitoring system is essential for patient safety. In instances where patients may 1144

require assistance, or in an emergency; for example, if a patient vomits, treatment can be 1145

suspended immediately. 1146

1147

CRITERION 11.3 1148

Patients are reviewed for their fitness to continue and for their psychosocial needs throughout 1149

a course of treatment. 1150

Nursing Practice Principle 2: The information and education needs of patients and their 1151 carers are identified and met. Refer to Appendix A. 1152 1153


Weekly review should include documentation of any radiation-induced side effects (preferably 1155

using a recognised acute toxicity scale) with documention of any interventions provided or 1156

recommended. All interventions suggested or introduced must be followed up to determine 1157

effectiveness. 1158

1159

Progress reviews allow the patient’s psychosocial wellbeing to be monitored and any issues 1160

managed in an appropriate and timely manner. 1161

1162

Patients should be given the opportunity to discuss any relevant issues with staff throughout 1163

their treatment course. 1164

1165

Nursing Practice Principle 4: Healthcare professionals are skilled in identifying the 1166

potential effects of radiation therapy and the impact of treatment on patients. Refer to 1167

Appendix A. 1168

1169

Nursing Practice Principle 5: Optimal patient outcomes are achieved through effective 1170

multidisciplinary teamwork. Refer to Appendix A. 1171

1172


• There is a system to cross-check specific data prior to the first treatment to ensure all 1174

aspects of the intended plan are met, including: 1175

o that the treatment plan has been signed by the treating radiation oncologist; 1176

o that the treatment plan, chart and/or electronic record and verify (RV) system 1177



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have been checked at least once; 1178

o where relevant, that digitally reconstructed radiographs (DRR) or simulation 1179

images have been checked at least once; 1180

o that an independent monitor unit calculation (or dose measurement for modulated 1181

treatments) has been performed; 1182

o Appropriate treatment parameter data are crosschecked to the treatment plan 1183

and set-up at the first treatment session and whenever there is any modification 1184

of the treatment plan. 1185

• There is a written protocol on verification imaging requirements, which includes 1186

frequency of imaging for various sites, radiographic technique, radiation exposure, 1187

acceptable variation from isocentre and the process of review. 1188

• Specialised staff and ancillary support equipment are available to deliver radiation therapy 1189

treatment safely to: patients undergoing chemotherapy concurrently with radiation therapy, 1190

paediatric patients, patients with cardiac pacemakers or implanted defibrillators, and 1191

patients with other special needs. 1192

1193

1194



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SAFETY AND QUALITY MANAGEMENT 1195

STANDARD 12—SAFETY, QUALITY AND IMPROVEMENT PROCESSES 1196

Safety and quality processes ensure safe, quality patient care with a commitment to 1197

quality improvement. 1198

1199

CRITERION 12.1 1200

Facility governance acknowledges and supports safe practice, quality improvement, 1201

innovation and the safe and considered introduction of new technologies. 1202

1203


Risk management proactively reduces identified risk to an acceptable level with preventative 1205

measures rather than reactive remedies. It plays a vital role in supporting and informing 1206

decision-making in providing a safe and secure environment for patients, staff and the 1207

public.[96] 1208

1209

CRITERION 12.2 1210

Risk to patients, staff and the public is managed in accordance with the relevant WH&S 1211

legislation for the respective jurisdiction, national standards and the principles of safe practice. 1212

1213


Risk Management and the Guidelines for Managing Risk in the Healthcare Sector (AS/NZS 1215

4360: 2004) describe a coordinated approach to clinical risk management. Two Australian 1216

bodies provide direction on safe working practices and environments. 1217

1218

Safe Work Australia requires that facilities provide a safe environment for all employees in 1219

compliance with relevant workplace safety directives. It also requires each facility to have an 1220

incident notification, investigation and reporting system for all staff and patient incidents that 1221

complies with workplace safety directives. In addition, all staff should be trained in manual 1222

handling procedures relevant to their daily duties.[94] 1223

1224

The National Occupational Health and Safety Commission require all facilities to meet all 1225

building regulations contained in the Occupational Health and Safety Act. It also requires each 1226

facility to ensure that all chemical use and chemical storage meets relevant Occupational 1227

Health and Safety Acts. Risk assessments on all equipment and chemical use should be 1228

undertaken and reviewed on an annual basis. 1229

1230

Similar information is available from the New Zealand Department of Labour. 1231

1232

Good cleaning practices help to reduce infection hazards and have a direct influence on the 1233

quality of care. The cleanliness of the facility should be maintained and monitored. 1234

1235

CRITERION 12.3 1236

Facility governance, policies and procedures incorporate the intent of The Australian Charter 1237

of Healthcare Rights or the Code of Health and Disability Services Consumers' Rights in New 1238

Zealand. 1239



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1240


There are procedures to address patients’ rights and needs. 1242

1243

Feedback on patient satisfaction is regularly obtained, analysed, reported and responded to. 1244

‘Complaint’ handling procedures should be readily available to any individual about whom a 1245

participating organisation holds personal information. The facility is required to promote this 1246

process and ensure that it is easy to use and free of charge.[2] 1247

1248

There are ten underlying principles in the Australian Privacy Act (1988): collection, use and 1249

disclosure, data quality, data security, openness, access and correction, identifiers, 1250

anonymity, trans-border data flows and sensitive information.[95] 1251

1252

The Australian Privacy Act (1988) and the Australian Freedom of Information Act (1982) 1253

outline processes for sharing of relevant patient information between health professionals.[96,97] 1254

1255

CRITERION 12.4 1256

The technical quality of care and patient outcome is evaluated, compared to benchmarks for 1257

best practice, and acted upon accordingly. 1258

1259


Quality audit entails systematic and independent evaluation of the quality system or its 1261

components to assess performance and to identify areas that need updating or improvement. 1262

A quality audit documents current practice, and can lead to improved service delivery.[6,98] 1263

1264

Chart rounds or clinical audits provide a useful forum for in-house peer review, education and 1265

effective real-time communication among all members of the multidisciplinary team 1266

responsible for delivering radiation therapy treatment.[99] It is paramount to good patient care 1267

for this communication to be clear, precise and accurate in detail. A regular chart audit should 1268

be a part of the quality assurance program of every radiation oncology facility.[100] 1269

Nursing Practice Principle 6: Patients and their carers have the opportunity to participate in 1270 all aspects of care. Refer to Appendix A. 1271 1272


• A designated multidisciplinary committee oversees all quality improvement activities. 1274

• Risk management strategies are used to overcome potential threats and weaknesses in 1275

the provision of radiation therapy treatment services. 1276

• There are programs to educate all staff on quality improvement processes. 1277

• There is an elected occupational health and safety officer responsible for liaising 1278

between with management and staff about safe work conditions and compliance with the 1279

relevant WH&S legislation. 1280

• There is an up to date ‘hazardous chemical database’ and relevant ‘material safety data 1281

sheets’ available at the point of storage of hazardous chemicals. 1282

• There is protective equipment, including gloves, goggles; aprons and adequate fume 1283

cupboards available for staff when working with chemical hazards. 1284



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• Equipment safety notes are available to all staff expected to use clinical equipment. 1285

• There is a fire and emergency evacuation plan with which all staff are familiar. All staff 1286

should attend an orientation program about the plan and annual training updates. 1287

• Manual handling refresher training is conducted by clinical staff on an annual basis. 1288

• There is correct signage to alert staff, patients and the public of all potential hazards, 1289

including flammable chemicals, radiation warnings and electrical hazards. 1290

• There is an infection control policy that includes procedures and equipment consistent 1291

with national minimum standards and infection control principles that identifies the 1292

potential health risks and safety precautions, specifies action plans and documentation 1293

procedures, and describes routine work and cleaning practices. This policy is revised 1294

and updated regularly. 1295

• There is a manual of standard operating procedures and protocols that is readily 1296

accessible to all staff employed or contracted to provide services. 1297

• There is a formal complaint handling procedure. 1298

• There is a policy for the provision of patient information to other health care providers. 1299

• Professional interpreters are provided for patients from culturally diverse backgrounds 1300

who have difficulty understanding the English language. 1301

• The physical environment is conducive to maintaining patient dignity and privacy. 1302

• There are regular patient chart rounds or clinical audits e.g. RANZCR Guidelines for 1303

Safe Practice of Stereotactic Body Radiation Therapy [101] . 1304

• The treatment chart is checked upon completion of a course of radiation therapy 1305

treatment for concordance with the prescribed treatment. 1306

1307

1308

https://www.ranzcr.com/search/s%20afe-practice-of-stereotactic-body-%20radiation-therapy-guidelines

https://www.ranzcr.com/search/s%20afe-practice-of-stereotactic-body-%20radiation-therapy-guidelines



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STANDARD 13—RADIATION SAFETY 1309

All radiation exposures are managed to minimise risk to patients, staff and the public. 1310

1311

CRITERION 13.1 1312

The management plan for radiation safety defines responsibilities and delegations of all 1313

persons involved with radiation exposures and management of radiation safety. 1314

1315


The responsible person has the overall management responsibility and control of the 1317

radioactive source, radiation-producing equipment or medical practice. It may be a natural 1318

person, a corporation, chief executive officer or director of medical services for example.[99] 1319

1320

Each facility that uses radiation is legally required to appoint a natural person as a radiation 1321

safety officer (RSO) to manage radiation safety. In radiation oncology facilities that person will 1322

generally be a senior physicist. 1323

1324

The radiation safety management plan must comply with jurisdictional legislative 1325

requirements. Sufficient resources are needed to support its practical application. The plan 1326

needs to address areas relevant to radiation safety (current IAEA BSS standards): 1327

• work practices for managing medical exposures including the management of pregnant 1328

patients; 1329

• roles and responsibilities in the facility, including reporting and delegation; 1330

• staff training and resource allocation; 1331

• protection and monitoring of staff, patients and areas accessible by the public, quality 1332

assurance procedures and records for all equipment used in the treatment delivery 1333

pathway; 1334

• incident and accident reporting; 1335

• maintenance of records as required by regulatory authority, for workers, radiation 1336

sources and apparatus, and premises; and 1337

• emergency procedures. 1338

1339

The multidisciplinary radiation safety committee should monitor compliance with legislative 1340

requirements, and make recommendations to the facility. 1341

1342

The main duty holders under safety regulations for radiation oncology facilities must be 1343

qualified and one or more must be closely involved in every radiation therapy practice or 1344

procedure.[47] As the radiation therapy treatment prescription provides the justification for the 1345

exposure of the patient, the radiation oncologist maintains responsibility for overall radiation 1346

protection of the patient (IAEA BSS). 1347

1348

CRITERION 13.2 1349

The radiation oncology facility maintains a register of equipment, staff and safety notifications 1350

relating to radiation safety and ensures notification and communication as required by the 1351

regulatory authority. 1352

1353



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The information required on radiation equipment includes treatment room location, beam 1355

energy and modality. Radiation source information required includes the source type, its 1356

strength and location. The location of radioactive sources should be easy to access by all 1357

emergency staff, including fire fighters and police. 1358

1359

Licences are required to acquire, transport and dispose of sealed and unsealed sources for 1360

diagnostic and therapeutic use. The RSO must ensure that there is safe storage accessible 1361

only by qualified staff and that, sources are handled only by qualified staff. Safety procedures 1362

will include: measures to prevent theft, damage and unauthorised use or disposal; processes 1363

to ensure radioactive sources are under control at all times; procedures to ensure that 1364

receivers possess valid authorisation; and periodic inventory. 1365

1366

Legislation in each jurisdiction specifies the acceptable dose limits around premises and in 1367

controlled areas. The RSO must ensure there is compliance with these dose limits and that 1368

interlocks and warning signals are as specified by the legislation. 1369

1370

The Code of Practice states that the responsible person has accountability for the movement, 1371

management and safe discharge of brachytherapy patients. Furthermore, the responsible 1372

person must minimise the risk of contamination from accidental spill or the loss of sources, 1373

and ensure the safe movement and removal of radioactive sources. 1374

1375

In the event of a patient death while undergoing treatment with radioactive substances, 1376

whether sealed or unsealed, and if the deceased still retains, in or on the body, significant 1377

amounts of radioactivity the RSO must detail administrative procedures and instruct all 1378

persons who have a risk of exposure to the deceased. 1379

1380

CRITERION 13.3 1381

Appropriate equipment and resources are available for radiation survey measurement in both 1382

routine checks and emergency situations. 1383

1384


Radiation oncology facilities must protect the health and safety of staff from the harmful effects 1386

of radiation by personal monitoring, protective equipment and training. 1387

1388

All staff with access to controlled areas, including administrative, nursing and cleaning staff, 1389

need personal monitoring devices.[97] Records of personal monitoring must be regularly 1390

checked by the RSO or delegate. Unusual doses, including doses in excess of the norm but 1391

not necessarily in excess of prescribed limits, need to be investigated and, if necessary, 1392

remedial action taken. Staff must be advised of their radiation assessment results. 1393

1394

Defence-in-depth principles are applied to procedures and processes involving radiation. 1395

These refer to the use of sufficient layers of physical or procedural measures in the facility 1396

design and operating procedures to prevent accidents, minimise harm from error and restore 1397

safety should an accident occur.[97] 1398

1399



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Equipment for monitoring radiation and for use in responding to emergency situations includes 1400

a calibrated survey meter that is traceable to a national standard, electronic personal 1401

dosimeters, spill kit, source handing devices, and protective clothing. In the selection of 1402

equipment available and used for the measurement of radiation dose or radioactive 1403

contamination, there should be surplus equipment, which ensures backup. 1404

1405

The radiation safety committee should ensure that people in a facility know their role and the 1406

procedures to be followed in the event of a radiation accident or unplanned exposure. Specific 1407

equipment is required to assess the scope of a radiation emergency or accident and it is the 1408

legal responsibility of the facility to ensure these resources are available. The RSO must 1409

ensure its availability and current calibrations. In the event of an emergency the RSO must 1410

ensure that a system is in place to contact the appropriate staff qualified to deal with the 1411

emergency. 1412

1413

CRITERION 13.4 1414

There is regular review of all radiation safety procedures and physical verification to confirm 1415

continuing radiation safety. 1416

1417


The radiation management plan should include a review of any changes in techniques and 1419

equipment for radiation safety; identify and address any failures and shortcomings; and 1420

maintain the cooperation of all staff, who should be consulted and informed about radiation 1421

safety management. 1422

1423


• Working conditions in respect to occupational exposure to radiation are adapted for 1425

female workers who notify their employer should they become pregnant. 1426

• There are protocols, conforming to respective state, national and international 1427

regulations, for the handling and management of brachytherapy and unsealed sources. 1428

• There are protocols based on defence-in-depth principles for radiation emergency 1429

situations that include communication with all qualified staff. 1430

• Records of the calibration of all radiation survey measurement devices are maintained. 1431

1432

1433



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STANDARD 14—INCIDENT MONITORING PROGRAM 1434

Participation in incident monitoring programs provides confidence that radiation is 1435

safely delivered in a radiation oncology facility with a safety-conscious culture 1436

focused on learning and prevention of error. 1437

1438

CRITERION 14.1 1439

The radiation oncology facility participates in an incident monitoring program. 1440

1441


Governance ensures accountability of clinical performance and the delivery of safe treatment. 1443

1444

All incidents and adverse events that occur within the facility must be recorded. Not all will be 1445

directly related to the physical delivery of radiation therapy. The RSO must ensure immediate 1446

internal reporting of any radiation incident or unplanned exposure, including assessments of 1447

significance, results of investigation and any corrective action taken. 1448

1449

Incident reporting mechanisms such as root cause analysis, micro systems analysis and 1450

failure mode and effects analysis are methods of documenting and analysing errors and may 1451

be used to audit risk management interventions. A register of all incidents and errors occurring 1452

in a radiation oncology practice is an essential part of a quality program.[7] 1453

1454

Documentation and records of clinical data should be detailed enough to enable reconstruction 1455

of events in the future.[37,60,99,103,106] 1456

1457

An open disclosure policy is supported by management. The staff members are trained in 1458

open disclosure processes. 1459

1460


• There is a non-punitive reporting system that encourages feedback on safety issues that 1462

includes clinical performance. 1463

• In the event of unintended dose being delivered there are copies of reports to the 1464

relevant authority and any subsequent advice received from the authority. 1465

• There is evidence of open disclosure practice. 1466

• There is a process that enables the sharing of information on lessons learned from 1467

adverse events with other parts of the health system and other facilities. 1468

1469



Version 3, 2021

STANDARD 15—DOSIMETRIC INTERCOMPARISON 1470

Regular participation in dosimetric intercomparisions ensures confidence that 1471

radiation dose is accurately delivered in a radiation oncology facility. 1472

1473

CRITERION 15.1 1474

The radiation oncology facility participates in ongoing dosimetric intercomparisons of at least 1475

one photon beam and one electron beam every two (2) years, and on commissioning any new 1476

equipment. 1477

1478

CRITERION 15.2 1479

Intercomparisons include at least one level III dosimetric intercomparison every four (4) years 1480

using a treatment scenario relevant for the particular centre. 1481

1482


The IAEA recommends that all teletherapy equipment outputs are compared at least once 1484

every two years in a regional, national or international program for independent dose 1485

verification.[45] Dosimetric intercomparison is necessary to independently verify the 1486

performance of the radiation equipment and should ideally be performed by an independent 1487

centre. Examples for this are the Radiological Physics Centre in Houston 1488

(http://rpc.mdanderson.org/RPC/home.htm) or the EQUAL network in Europe (EQUAL via 1489

http://www.estro.be/) and now the Australian Clinical Dosimetry Service (ACDS). 1490

1491

Three different levels of complexity are defined for dosimetric intercomparisons:[105] 1492

• Level I: This constitutes an independent check of beam calibration under reference 1493

conditions in a physical phantom, usually water. It typically consists of only one 1494

measurement point. Such services are offered; for example, by the ACDS, Radiological 1495

Physics Center (Houston) and the IAEA. 1496

• Level II: A level II intercomparison verifies not only the dose under reference conditions 1497

but also the accuracy of some other factors required for treatment planning. As electron 1498

dosimetry intrinsically requires a verification of depth dose to determine the appropriate 1499

point of measurement and the electron energy, electron intercomparisons are necessarily 1500

a level II dosimetric exercise.[106] The measurements in level II dosimetric intercomparisons 1501

are done in a physical phantom, however, this may include inhomogeneities and/or surface 1502

contour changes.[107] 1503

• Level III: A level III intercomparison requires the use of an anthropomorphic phantom 1504

which is planned and treated as similar to a patient as possible. This can be a full 1505

anthropomorphic phantom[108] or a semi-anatomical phantom.[109-111] 1506

1507

The advantage of a level III dosimetric intercomparison is that the entire treatment chain from 1508

the acquisition of diagnostic images to the treatment set-up and delivery can be verified. The 1509

disadvantage of verifying many steps in one procedure is that it is often difficult to identify 1510

which step has contributed to a particular outcome. As such it is required to repeat 1511

measurements and check smaller segments of the treatment chain if the overall level III check 1512

identifies a problem. 1513

1514

http://rpc.mdanderson.org/RPC/home.htm

http://www.estro.be/



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A level III dosimetric intercomparison also records the influences of differences in treatment 1515

technique and equipment available in participating centres. 1516

1517

Intercomparisons are also useful to verify other aspects of the radiation therapy delivery. 1518

Examples are brachytherapy [112] and electron irradiation.[106] 1519

1520

Participation in clinical trials requires rigorous quality assurance. Dosimetric intercomparisons 1521

constitute an important part of the process ensuring that treatment in all centres participating 1522

in a multicentre trial is performed in a similar way. 1523

1524

Dosimetric intercomparisons reduce the risk of a serious error. Many of the incidences 1525

reported in IAEA safety report series 17[89] could have been prevented if regular dosimetric 1526

intercomparisons were performed. 1527

1528

Participation in dosimetric intercomparisons itself improves performance—centres who have 1529

previously participated in an external dosimetric audit are less likely to be outside of an 1530

accepted limit on further dosimetric audits than centres that never participated in an 1531

intercomparisons.[113] 1532

1533


• The radiation oncology facility also participates in dosimetric intercomparisons of at 1535 least one kilovoltage (kV) beam every two years. 1536

1537



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STANDARD 16 — CLINICAL TRIALS AND EVIDENCE BASED PRACTICE 1538

Any participation in human clinical trials is supported by governance and 1539

infrastructure to ensure quality care oversight. 1540

1541

Evidence based practice ensures the integration of the best current evidence with 1542

clinical expertise to provide optimal care to each patient. 1543

1544

CRITERION 16.1 1545

Participation in clinical trials conforms to international guidelines of good clinical practice. 1546

1547


Optimal models of cancer care describe improvements in quality that occur through 1549

participation in clinical trials, based on better outcomes for trial participants and changes in 1550

culture that arise from clinical research. These include changes in attitude to reviewing the 1551

evidence base of treatment, compliance with protocols, and an improvement in evidence-1552

based practice. 1553

1554

Clinical trials are research investigations in which people volunteer to test new treatments, 1555

interventions or tests as a means to prevent, detect, treat or manage various diseases or 1556

medical conditions.[114] 1557

1558

The World Health Organization (WHO) definition for a clinical trial is 1559

‘any research study that prospectively assigns human participants or groups of humans to 1560 one or more health-related interventions to evaluate the effects on health outcomes’. 1561

In Australia, all research involving humans must comply with the principles set out in the 1562 following guidelines: 1563

• National Statement on Ethical Conduct in Human Research (2007) — updated 1564 2018 (National Health and Medical Research Council)(link is external) 1565

• Australian Code for the Responsible Conduct of Research (link is external) 1566 (developed jointly by the National Health and Medical Research Council, the 1567 Australian Research Council and Universities Australia) 1568

• Applicable State and Territory guidelines. 1569 1570

Clinical trials of medicines and medical devices also must comply with: 1571

• ICH Guideline for Good Clinical Practice (link is external) - (Therapeutic Goods 1572 Administration) 1573 1574

Clinical trials of medical devices must also comply with: 1575

• ISO 14155:2020 Medical devices (link is external) - Clinical investigation of medical 1576 devices for human subjects: Good clinical practice (ISO) 1577

1578

The infrastructure required for participation in clinical trials is dependent on factors related to 1579

the individual trial. This means that the indicators used by most multi-centre trials groups relate 1580

to accrual, and data completeness and accuracy (see figure 1 and table 1 below). 1581

1582

http://https/nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

http://https/nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

https://nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

https://www.tga.gov.au/publication/note-guidance-good-clinical-practice

https://www.iso.org/standard/71690.html



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Figure 1 [115,116] 1583

• Knowledge and experience of conducting and managing patients in a clinical trial. 1584 • Adequate funding and infrastructure support for clinical trials activity, particularly with the 1585

appointment of a local data manager/clinical trial coordinator, file storage space, and technology 1586 requirements. 1587

• Systems in place to ensure staff work to appropriate guidelines and standards. 1588 • Systems in place to provide training, education and development. 1589 • Ability to work within ethical and legal framework, such as International Committee on 1590

Harmonisation, Good Clinical Practice, Therapeutic Goods Administration. 1591

1592 Table 1: Clinical trial processes audit (source: RTOG, 2005: Appendix IV) 1593

Acceptable

minimum %

Eligibility and percent of patients evaluable 80

Percent complete forms—no additional inquiries 80

Timeliness of forms submission (including pathology and

chemotherapy flow sheets)

80

Submission of initial treatment planning data 80

Responsiveness to additional inquiries 80

Submission of treatment data on completed cases 80

1594

A multidisciplinary model of care is believed to provide the best outcomes and participation by 1595

the following groups should be considered: ROs, ROMPs, RTs, physicians, surgeons, 1596

radiologists, pathologists, pharmacists, nurses, data managers and clinical trial coordinators. 1597

1598

If the trial necessitates advanced, complex planning or treatment radiation techniques, a 1599

higher level of QA is required when compared to a trial incorporating standard radiotherapy.[115] 1600

1601

As part of research governance, centres should have a research review meeting as a quality 1602

process to review the operational aspects of research, including infrastructure, feasibility, 1603

accrual, protocol compliance, and other technical issues; for example, dosimetric aspects of 1604

compliance. 1605

1606

The Code of Practice for Exposure of Humans to Ionizing Radiation for Research Purposes 1607

requires all research involving the use of ionising radiation conducted in facilities shall be in 1608

accordance with legislation as described in the Radiation Protection Series No. 8.[118] 1609

1610

16.2 EVIDENCE BASED PRACTICE 1611

All clinical services are provided using evidence based or best practice principles. 1612

Commentary 16.2 1613

Evidence based practice underpins the provision of safe, quality care in all aspects of 1614 radiation oncology. 1615

Evidence-based clinical practice guidelines and recommendations are designed to assist 1616 decision making and guide best practice in the management of cancer. 1617



Version 3, 2021

These guidelines are based on the best evidence available at the time of publication and are 1618 a guide to appropriate practice, to be followed subject to the clinician’s judgement and the 1619 person’s preference in each individual case. 1620

As new evidence becomes available, existing resources may be updated or topic-specific 1621 updates may be developed to act as supplements to existing documents. [119,120] 1622

As per the Australian Commission On Safety And Quality In Health Care action 1.27[2]: 1623

The health service organisation has processes that: 1624

a. Provide clinicians with ready access to best-practice guidelines, integrated care 1625 pathways, clinical pathways and decision support tools relevant to their clinical 1626 practice 1627

b. Support clinicians to use the best available evidence, including relevant clinical care 1628 standards developed by the Australian Commission on Safety and Quality in Health 1629 Care 1630

Good clinical governance promotes clinical practice that is effective and evidence based. 1631 Provides clinicians with ready access to best-practice guidelines, integrated care pathways, 1632 clinical pathways, decision support tools, and the clinical care standards.[2,116,121] Radiation 1633 Oncology departments that, due to size and restricted resources, cannot develop their own 1634 practice guidelines are encouraged to identify and endorse clinical guidelines and pathways 1635 appropriate to their service. 1636

Radiation oncology services can contribute to the generation and promotion of evidence based 1637 practice through peer reviewed research, presentations and publications of locally run 1638 research activities within the accepted ethical rules and hierarchies of evidence. 1639

1640 SUPPLEMENTARY EVIDENCE 1641

• Ethics approval of all clinical trials from a committee in accordance with NHMRC or 1642

Health and Disability Ethics Committee (HEDC) guidelines. 1643

• The governance of clinical trial research is consistent with national and international 1644

standards, in particular those related to informed patient consent. 1645

• Infrastructure is sufficient to support clinical trials. This includes staffing, data 1646

management resources and facilities for file storage. 1647

• Regular research review meetings occur. 1648

• Evidence of departmental accepted and endorsed clinical guidelines and protocols. 1649

• Evidence of regular reviews of the endorsed clinical guidelines and protocols. 1650

• Evidence of departments generation and promotion of evidence-based practice 1651

through research, presentation and publications. 1652

• Committee and meeting records in which decisions about the implementation and use 1653

of best-practice guidelines, pathways and decision support tools and clinical care 1654

standards were discussed. 1655

• Audit results of adherence to available best-practice guidelines, decision support tools 1656

and clinical care standards. 1657

1658

https://www.safetyandquality.gov.au/node/3923

https://www.safetyandquality.gov.au/node/3923



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DEFINITIONS 1659

1660 Acceptance testing The process of verifying that equipment (both hardware and

software) operates to performance specifications agreed between the vendor and customer according to a mutually agreed acceptance protocol.

Accuracy Closeness of the agreement between the result of a measurement and a true value of the measurand (International vocabulary of basic and general terms in Metrology (VIM) draft 2004 revision, definition 3.5). If the true value cannot be determined, then an accepted value may be used as a substitute.

Brachytherapy Radiation treatment using radioactive material (mostly an encapsulated source) brought into close contact with the treatment area (often by surgical means).

Bolus Material (typically equivalent in density to normal tissue) placed directly on the patient in order to alter the dose distribution within the patient.

Commissioning The process of acquiring all the data from a piece of equipment that is required to make it clinically useable in a specific department. Therefore, the commissioning procedure will depend on clinical requirements in a particular centre and other equipment available. For radiation delivery devices commissioning can be divided into three phases: • data acquisition • beam modelling • verification.

Contouring A procedure that involves outlining regions and anatomical structures of interest including, but not limited to external patient contour, GTV/CTV/PTV, OAR, air cavities, bolus, artefacts and fiducial markers—using manual and/or computer-assisted methods.

Dosimetry The measurement of absorbed dose in matter resulting from exposure to ionising radiations. In the context of the standards ‘Dosimetry’ refers to the measurement of physical dose and the provision of these dose measurements for the purpose of treatment planning. Dosimetry can be classified as relative or absolute dosimetry.

Equipment In the context of the standards, the term equipment applies to all hardware and software used in a radiation therapy department.

Facility A real entity that provides radiation therapy services. Facility infrastructure

The framework of the amenities, both physical and operational, that support an organisational unit’s operation and function. This basic architecture and its ‘fit’ with the environment determine how well the unit functions and how adaptive it is to change and future requirements.

Incident An error, a near miss or any adverse event relating to patient care or patient, visitor and staff safety.

Intensity modulated radiation therapy

This term is used to describe the attempt to optimise the dose distribution during external beam radiation therapy delivery. Each radiation field is divided into small segments with varying radiation intensity which allows for target shape, location and the geometry of overlaying tissues. IMRT fields are typically designed using computer driven (or aided) optimisation. This is often referred to as ‘inverse treatment planning’.



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Interlock A device which can inhibit radiation from commencing or terminate an irradiation process when a certain condition occurs (e.g. someone entering the treatment room).

In-vivo dosimetry The measurement of absorbed dose to the patient at the time of treatment. The measured dose is compared with the planned dose to verify dose delivery. Doses are commonly measured with small detectors which will not affect the therapeutic dose distribution. These detectors may be diodes, thermoluminescent dosimeters (TLDs) or similar devices.

Isocentre A point at the intersection of the rotational axes of gantry, collimator and treatment couch.

Monitor units A MU corresponds to a known amount of charge collected on the internal ion chamber of a linear accelerator. The ion chamber can be calibrated so that the number of MUs relates to the absorbed dose of radiation delivered to the reference point under reference conditions. A MU is a measure of linear accelerator output. Commonly, linear accelerators are calibrated for a specific energy such that 100 MU gives an absorbed dose of 1 Gy under reference conditions.

Multileaf collimator A device that is mounted in the collimator or replaces one of the collimator pairs. It consists of movable leaves which can be positioned freely to allow conformal shielding of organs at risk.

Organisation The legal entity to which a radiation oncology service is affiliated. Operational infrastructure

The management and business systems, structure and processes of the unit, the unit’s services and staff.

Patient pathway A patient’s progress through a facility. Phantom In radiation therapy, the term ‘phantom’ is used to describe a

material and structure which models the radiation absorption and scattering properties of human tissues of interest.

Quality assurance All the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality.

Quality care Care based on commonly accepted best practice and the associated patient outcomes.

Quality control The techniques and methods built into an organisation’s operations to control individual processes.

Quality improvement Actions taken to review and enhance the quality of a process and/or service.

Quality program Encompasses all quality activities as listed. Radiation oncology medical physicist

A person who is qualified in medical physics to perform the necessary dosimetric calculations, measurements and monitoring in radiation oncology. A suitable person will: (a) be on the Qualified Medical Physics Specialists (QMPS) Register in Radiation Oncology held by the Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM); or (b) have an equivalent level of training, skills, knowledge and expertise to a person listed on the ACPSEM Qualified Medical Physics Specialists (QMPS) Register in Radiation Oncology as determined by a relevant authority.

Radiation oncologist A person who is registered as a medical practitioner by the relevant Medical Board and is a fellow of the RANZCR or equivalent and is licensed to prescribe radiation therapy.

Radiation oncology patient record

The primary source of information and includes the treatment chart (prescription and treatment sheet; paper based or electronic), all



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dosimetry and calculation data, as well as localisation and position verification data and images.

Radiation oncology service

The sum total of all affiliated radiation oncology facilities.

Radiation therapist A person who is qualified to standards set by the ASMIRT or registered to practise according to jurisdictional requirements.

Radiation therapy equipment

For the purposes of the standards such equipment is defined as all hardware and software relevant to:

• patient imaging whether radiation emitting or not;

• the planning and calculation of radiation dose to a patient;

• the delivery of radiation treatment to a patient; and

• monitoring, measuring and/or otherwise controlling radiation dose.

Radiation safety officer

A suitably qualified and experienced person who oversees all activities involving ionising radiation in a workplace. As such, the RSO is also responsible for training of others. Consequently, some of the duties may be delegated. The role and responsibilities of an RSO are defined by national standards.

Ready for care Is when the patient is ready to commence radiation treatment as agreed between the patient and the radiation oncologist. Patients are not considered to be ready for care if:

• the radiation oncologist considers treatment should not commence because the patient is in a postoperative healing phase and/or a post chemotherapy phase;

• any existing morbidities require prior therapy; or

• a delay is requested by the patient. Responsible person The person who has the overall management responsibility and

control of the radioactive source, radiation-producing equipment or medical practice. It may be a natural person, a corporation, chief executive officer or director of medical services for example [104]

Service See radiation oncology service. Suitably qualified Means registered (for regulated professions) or eligible for

registration on the ACPSEM Register of Qualified Medical Physics Specialists (for medical physicists), and licensed (where required) to practice according to relevant jurisdictional legislation and the defined scope of practice for that profession; and within any organisationally defined credentialing requirements applicable to specific aspects of practice.

Technical quality of care

Refers to the delivery of correct dose to the correct patient to the correct anatomical site as prescribed.

Treatment planning system

The computer hardware and software (including dose calculation algorithms) used to develop, evaluate and display a radiation treatment plan.

Treatment verification

The process of imaging and evaluating the position of the treatment isocentre, radiation treatment field and/or its shape, or anatomical volume against that determined in the treatment planning process.

Verification Sometimes referred to as Record and Verify or R&V, commonly refers to the matching of a simulated or planned treatment parameter with that set on the treatment unit for treatment delivery.

Waiting time The interval between the ready for care date and first radiation treatment being delivered.

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Appendix A- Nursing Practice Principles 2034

(to follow) 2035

radiation oncology practice standards part b guidelines v2

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