Quality Management in Radiotherapy

Introduction

Quality management (QM) is ‘the coordinated activities to direct and control radiotherapy procedures with regard to quality. The main aim of quality in radiotherapy is safe and effective treatment. In addition to ensuring that all treatments are optimized, a quality system should ensure that all possible measures are taken to prevent inappropriate exposures from occurring.

Safety culture

It is important that all cancer centres develop and nurture the concept of safety culture. The concept of safety culture arose following the Chernobyl accident and has been encouraged and developed by the IAEA, the nuclear power industry and many other organisations.

Safety culture is the combination of attitudes, ideas, commitment and actions that determine how safety is managed in an organisation. These concepts have been formulated into definitions by numerous groups. Two widely used examples of these definitions are:

• That assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, nuclear plant safety issues receive the attention warranted by their significance. International Nuclear Safety Advisory group (INSAG)
• The product of individual and group values, attitudes, perceptions, competencies, and patterns of behaviour that determine the commitment to, and the style and proficiency of, an organization's health and safety management. U.K. Health and Safety Commission (HSC)

An important concept is that development of a safety culture requires active participation from all workers, at all levels of an organisation. There must be a strong perception that management values safety and expects it to be a normal and accepted characteristic of the workplace, influencing the attitudes and behaviour of all workers.

The importance of a strong safety culture has become apparent in the detailed analysis of occupational accidents and disasters. It has become clear that organisations that have not developed a strong safety culture are vulnerable to accidents and failure. It is insufficient for workers to simply follow organisational processes. It is necessary for all workers to be alert for potential problems and for management to develop trust, so that incidents and near misses can be explored in a no-blame manner, to improve processes.

Organisations that have a good safety record and a safety culture tend to have the following characteristics:

Strong leadership with senior management commitment to safety, even at the expense of throughput.

Continual reflection regarding work practices, through monitoring, analysis and feedback for improvement.

Governance

Although all workers have individual responsibility for components of risk management, compliance with protocols and development of a safety culture, these concepts will not become entrenched as the organisational norm unless they are backed by unconditional management support. It is the responsibility of senior management to instil these qualities into an organisation, and to create an environment that supports them.

There are a number of steps that management must undertake to promote good risk management. These include:

• Demonstrating the commitment of senior management to the principles of risk management
• Emphasising a commitment to staff safety and a no blame approach to incident reporting
• Timely and thorough investigation of incidents and accidents, which are reported in a transparent manner
• Ensuring that staff have appropriate competency based training and re-training
• Ensuring the development of clear policies and procedures, and ensuring compliance
• Ensuring clear lines of communication
• Supporting and facilitating risk management activities including quality cycle activities, monitoring and data collection
• Ensuring that all equipment meets the required standards.

It cannot be emphasised too strongly that a safety culture cannot develop within an organisation without a sound governance structure. It is recommended that centres create a formal Quality Improvement Committee, chaired by a senior member of the management team, and with representatives form all the relevant groupings within the centre. Meetings of the Committee should be held regularly, and proceedings recorded with action points.

Auditing radiotherapy centres – internal audits

Peer review is a quality improvement and risk management process, the purpose of which is to protect patients from health professionals who have made poor management and treatment decisions. As the name implies, the concept of peer review is that the performance of one health professional is assessed by a group of his/her peers, or equals.

Peer review in medicine has been undertaken for many decades in a variety of guises. It may be a formal or an informal process; it may occur regularly or only in response to an identified problem; it may have implications for credentialing, scope of practice and remediation or as a routine component of the ongoing quality improvement program.

In radiotherapy, peer review is frequently carried out as an informal weekly process whereby all patients commencing radiation treatment are presented to a gathering of the radiation oncologists, radiation therapists and medical physicists in the centre. The patient's salient clinical features are presented, together with the management plan and some radiation treatment details. The participants provide feedback regarding the adequacy of the proposed management and/or treatment plan. In larger centres with subspecialist teams, peer review may be carried out within the subspecialist team. It is good practice to document the conclusions of any discussion.

At the other end of the spectrum, peer review is a formal process used to assess the competency of a health professional. This process may be a routine component of the organisation's quality improvement program, occurring every 1-2 years, or it may occur in response to an incident or complaint. A panel is convened to assess competency; this may include a retrospective review of the health professional's cases, or attendance at the health professional's clinics or procedures by a member of the peer review team, to observe the health professional's competency. In these circumstances the review process must be fair, unbiased and transparent, with the right of appeal.

It is important to emphasise that the function of peer review is to protect patients from harm. Each centres must determine the optimal manner to achieve this goal, within the local rules of the institution and the legislative framework of the country.

Auditing radiotherapy centres – external audits

As part of a comprehensive approach to quality assurance (QA) in the treatment of cancer by radiation, an independent external audit (peer review) is important to ensure adequate quality of practice and delivery of treatment. Quality audits can be of various types and levels, either reviewing specific critical parts of the radiotherapy process (partial audit) or assessing the whole process (comprehensive audit).

The IAEA has a long history of providing assistance for dosimetry (partial) audits in radiotherapy to its Member States. Together with the World Health Organization (WHO), it has operated postal audit programmes using thermoluminescence dosimeters (TLD) to verify the calibration of radiotherapy beams since 1969.

The IAEA has received numerous requests from developing countries to perform comprehensive audits of radiotherapy programmes to assess the whole process, including aspects such as organization, infrastructure and clinical and medical physics components. The objective of a comprehensive clinical audit is to review and evaluate the quality of all components of the practice of radiotherapy at the institution, including its professional competence, with a view for quality improvement. A multidisciplinary team comprising a radiation oncologist, a medical physicist and a radiotherapy technologist carries out the audit.

Incident reporting

The management of incidents, accidents and near misses is an important and critical component of risk management and safety within an organisation. Before discussing the significance of incident reporting, some definitions are necessary.

• An incident is a generic term defined as an unplanned event that results in, or may have resulted in, injury, damage or loss.
• An accident is an incident that has resulted in injury, damage or loss.
• A near miss is an incident that may have resulted in injury, damage or loss, but did not.

Incident reporting is also a component of incident management, which includes the immediate response to the incident, to remove immediate danger and to restore the facility to normal operation as soon as possible.

Incidents are an important signal to an organisation that the safety systems have failed. This may be indicative of an isolated deficiency in safety, or of more widespread organisational vulnerability to failure. In either case it is important to investigate the causes of the incident and its subsequent management, to reduce both the risk of further incidents and their impact.

For an incident reporting system to be effective, all incidents must be documented. This involves development and implementation of the following steps:

• An agreed definition of the events that are deemed to be incidents
• A scale of significance of the incident (for example the INES scale)
• A no blame culture that encourages reporting, rather than hiding of incidents
• A mechanism for reporting - preferable electronic (for example ROSIS)

Once the incident is documented, it must be investigated, analysed and reported to management. The report includes recommendations for changes in procedures, to reduce the risk of recurrence and/or injury or damage. These tasks should be the responsibility of an Incident Committee, which is a subcommittee of the Quality Improvement Committee. It is important that analysis of the incident is sufficiently detailed to identify the root causes which underlie incidents and initiate them. Using root cause analysis, it should be possible to determine all the steps leading from the root cause to the incident. In this manner, the root cause may be eliminated, or further preventative actions undertaken to reduce the risk that the root cause will initiate further incidents.

The associated links provide examples of incident reporting systems.

Safety of your staff

A radiation oncology facility represents a potentially dangerous workplace for staff, with many possible occupational hazards. In order to create a safe working environment for staff, affirmative actions are required by both management and individual workers.

Actions required by management include the following

• Ensuring that all equipment is well maintained, particularly with regard to radiation and electrical safety
• Ensuring that the workplace is safe, with adequate lighting and ventilation
• Ensure that placards, posters and barriers are erected to inform staff of hazards and to prevent entry to restricted zones.
• Ensuring compliance with relevant Occupational Health and Safety (OHS) regulations
• Development of an orientation program for new staff
• Requirement for training for new tasks and re-training for existing tasks
• Development of a safety culture throughout the organisation
• Development and support of a quality improvement program for risk management and a quality cycle for quality improvement
• Development and support of an incident reporting system that ensures all incidents and near misses are investigated promptly, with remedial action as appropriate.
• Initiate and support drills and emergency preparedness exercises.

Actions required by individual workers include

• Develop attitudes and behaviours that are aligned and contribute to a safety culture
• Being aware of the implications of their own actions
• Observe all OHS and other policies and procedures within the organisation
• Use the recommended manual handling technique
• Practice universal precautions for infection control and added precautions as required
• Maintain vigilance for hazards and promptly report any issues
• Be aware of emergency response procedures and participate in drills and emergency preparedness exercises
• Anticipate and avoid potentially dangerous or hazardous situations
• Be aware of access to security personnel.

Remember, staff should be the greatest asset of an organisation. A safe organisation is likely to be an efficient organisation.

Clinical research

The importance of research in the context of quality improvement cannot be stressed too much. Research provides new knowledge that should be used to guide future practice. It is important that centres become involved in research, as this will provide knowledge of the local situation. It may not be appropriate to implement changes based on data from centres in other global regions, due to possible marked differences in populations, disease profiles, co-morbidities, and treatments.

Retrospective

Retrospective studies are a very useful method that helps to determine the outcomes achieved by a service. Retrospective studies in oncology frequently relate to the outcome of a particular disease, with the typical endpoints being survival, disease free survival, local control and the rate of specified complications. Through statistical analysis that corrects for differences in the major variables, comparison of the outcomes with published data provides a guide to the performance of the centre. In this manner retrospective studies may serve to generate hypotheses that should be tested in prospective studies.

Prospective

Prospective clinical studies are utilised to gather new data or to test hypotheses. In most cases in oncology, prospective clinical studies can be classified into 3 broad categories, being phase I, phase II and phase III studies. These are defined briefly as:

• Phase I study - This is used predominantly in new drug assessment, and involves assessment of the pharmacology and tolerability of drugs
• Phase II study - This utilises the results of the phase I study to determine whether the drug or other treatment demonstrates efficacy in the treatment of a particular cancer and whether this new treatment shows sufficient promise to warrant a phase III trial.
• Phase III study - The phase III study is a randomised controlled clinical trial, in which the new treatment is compared with the current standard treatment. 

ARBR is actively involved in a number of Phase II studies. For example, a large work program is related to resource sparing studies, in which a novel hypofractionated radiation schedule is compared with a standard schedule.

QUATRO

The IAEA has developed a methodology for comprehensive quality audits of radiotherapy practices called Quality Assurance Team for Radiation Oncology (QUATRO). QUATRO audits are organized by the IAEA in response to voluntary requests by eligible radiotherapy centres. They draw on high level international experts with broad experience in the field who comprise the auditing teams for QUATRO missions. Teams are composed of a radiation oncologist (RO), medical physicist (MP) and RTT. They receive specialized training in order to ensure consistency in the auditing approach among the teams and between geographical regions.