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Oncology Publications Oncology Department

11-11-2016

Radiation Oncology Quality and SafetyConsiderations in Low Resource Settings: AMedical Physics PerspectiveJacob Van DykThe University of Western Ontario, vandyk@uwo.ca

Ahmed Meghzifene

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Citation of this paper:Van Dyk, Jacob and Meghzifene, Ahmed, "Radiation Oncology Quality and Safety Considerations in Low Resource Settings: AMedical Physics Perspective" (2016). Oncology Publications. 117.https://ir.lib.uwo.ca/oncpub/117

Author’s Accepted Manuscript

Radiation Oncology Quality and SafetyConsiderations in Low Resource Settings: AMedical Physics Perspective

Jacob Van Dyk, Ahmed Meghzifene

PII: S1053-4296(16)30063-7DOI: http://dx.doi.org/10.1016/j.semradonc.2016.11.004Reference: YSRAO50575

To appear in: Seminars in Radiation Oncology

Cite this article as: Jacob Van Dyk and Ahmed Meghzifene, Radiation OncologyQuality and Safety Considerations in Low Resource Settings: A Medical PhysicsP e r s p e c t i v e , Seminars in Radiation Oncology,http://dx.doi.org/10.1016/j.semradonc.2016.11.004

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RADIATION ONCOLOGY QUALITY AND SAFETY CONSIDERATIONS IN LOW

RESOURCE SETTINGS: A MEDICAL PHYSICS PERSPECTIVE

Jacob Van Dyk, DSc,* Ahmed Meghzifene, PhD+

* Jacob Van Dyk BSc, MSc, FCCPM, FAAPM, FCOMP, DSc(hon), Professor Emeritus,

Departments of Oncology and Medical Biophysics, Western University, London, Ontario,

Canada

+ Ahmed Meghzifene PhD, Section Head, Dosimetry and Medical Radiation Physics Section,

Division of Human Health, Department of Nuclear Sciences and Applications, International

Atomic Energy Agency (IAEA), Vienna, Austria

Address reprint requests to Jacob Van Dyk, DSc, 146 Parks Edge Crescent, London, Ontario,

Canada N6K 3P7. E-mail: vandyk@uwo.ca Phone: 519-472-2951

Disclosure: Jacob Van Dyk has a license agreement with Modus Medical Devices Inc., London,

Ontario, Canada associated with radiation therapy quality assurance equipment.

Page 2 of 34

Abstract

The last few years have seen a significant growth of interest in the global radiation therapy crisis.

Various organizations have quantified the need and are providing aid in support of addressing the

shortfalls existing in many low-to-middle income countries (LMICs). With the tremendous

demand for new facilities, equipment and personnel, it is very important to recognize the quality

and safety challenges and to address them directly. An examination of publications on quality

and safety in radiation therapy indicates a consistency in a number of the recommendations;

however, these authoritative reports were generally based on input from high-resourced contexts.

Here we review these recommendations with a special emphasis on issues that are significant in

LMICs. While multidimensional, training and staffing are top priorities; any support provided to

lower resourced settings must address the numerous facets associated with quality and safety

indicators. Strong partnerships between high-income and other countries will enhance the

development of safe and resource-appropriate strategies for advancing the radiation treatment

process. The real challenge is the engagement of a strong spirit of cooperation, collaboration and

communication between the multiple organizations in support of reducing the cancer divide and

improving the provision of safe and effective radiation therapy.

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1. Introduction

There has been a recent increased recognition of the growing cancer crisis, especially in low-to-

middle income countries (LMICs). This is clearly demonstrated by Figure 1(a) which shows a

significant increase in the number of publications dealing with the global cancer problem of

which nearly 30% were published in 2014 and 2015. What is noteworthy, however, is that a

similar publications search on the global radiotherapy problem yielded about 3% of the global

cancer papers and of those about 80% were published in 2014 and 2015 (Figure 1(b)). The most

significant recent report is the Lancet Oncology Commission on global access to radiotherapy1.

This report indicates that radiation therapy (RT) is essential for effective cancer treatment, but the

availability of RT in LMICs is unacceptably low. It quantifies the shortfall in access to RT by

country and globally for 2015 to 2035 based on current and projected need, and it shows the

substantial health and economic benefits to investing in RT in spite of the high up-front costs.

The projections to 2035 indicate the need for very significant growth in RT facilities and

personnel so that 22,000 additional medical physicists will be required in LMICs to meet the

overall demand and recommends an action in human resource capacity building of at least 6,000

newly trained medical physicists by 2025. With this tremendous demand for new facilities,

equipment and personnel, it is important to recognize the quality and safety considerations in the

lower resourced settings and to address them directly as a means of maximizing treatment quality

and minimizing potential patient mis-administrations.

As pointed out in a report by the International Atomic Energy Agency (IAEA) on inequity in

cancer care2, “quality” in health care is a multidimensional concept3 with components of

‘inequality’ (or disparity) encompassing all the other elements of ‘quality’. A program to improve

quality must therefore include activities to address the inequality problem. While this paper does

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not address the problems of solving basic inequalities, it does address quality issues related to

societal contexts where RT infrastructure is just being developed.

2. The Radiation Treatment Process and Elements of Quality and Safety

The radiation treatment process is complex with multiple steps and involves various professional

personnel. Elements of quality and safety occur at both the programmatic and individual patient

level as shown in Figure 2.

3. Impact of Quality on Patient Outcome

There is growing quantitative evidence that the quality of radiation treatment has a direct impact

on clinical outcomes. A recent review4 which specifically addressed the question “Does quality

of radiotherapy predict outcomes of multicenter cooperative group trials?” found, through a

thorough literature review, that in nearly half the trials, clinical failure rates were significantly

higher after inadequate versus adequate RT and that significantly worse overall and progression-

free survival occurred after poor quality RT. Peters et al 5 demonstrated significantly inferior

outcomes for those patients with major deficiencies in their treatment plans from data submitted

for review for a large international phase III trial of head and neck cancers comprised of 687

patients. They noted that centers treating only a few patients are the major source of quality

problems. Analogous data regarding dosimetry audit pass rates have been presented by the

Radiological Physics Center / Imaging and Radiation Oncology Core and demonstrated that the

pass rates improved with the number of machines in the department, with a pass rate of about

78% for departments with 1 to 2 machines versus 86% for departments with 5 or more

machines6.

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The problem of treatment errors is a more extreme manifestation of poor treatment quality and

has the potential for much more significant negative short term clinical consequences7-10

. New

technologies provide new risks of treatment errors as indicated by the 2009 ICRP report8, the

articles from the New York Times11

and multiple other reports12-15

.

4. Overview of Quality and Safety Considerations

In 1988, the World Health Organization defined quality assurance (QA) as “all those procedures

that ensure consistency of the medical prescription and the safe fulfillment of that prescription as

regards to the target volume, together with minimal dose to normal tissue, minimal exposure of

personnel, and adequate patient monitoring aimed at determining the end result of treatment”16

.

Thus, the components of QA include:

Dose delivered to the target according to the prescription

Safe dose to normal tissues

Minimal dose to personnel

Patient monitoring

Over the years, multiple reports have been written on quality assurance programs and quality

control procedures with the aim of safely delivering the prescribed dose to the patient. However,

in spite of these reports, treatment errors have occurred, albeit in only a very small percentage (1-

2%) of all RT patients treated 17, 18

, with the rate of serious or adverse errors estimated to be

around 0.2% per patient 18, 19

. Over the last decade, various international and national

organizations have provided recommendations on how RT can be made safer. Dunscombe 20

performed a detailed review of seven authoritative reports 8-10, 21-24

published since 2008 which

provided 117 recommendations. Through a mapping exercise, the 117 recommendations were

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distilled to 61 unique recommendations with 12 topics being identified in three or more of the

seven documents. These were, in order of most to least cited: training, staffing, documentation,

incident learning, communication, checklists, quality control and preventive maintenance,

dosimetric audit, accreditation, minimizing interruptions, prospective risk assessment, and safety

culture. IAEA TRS43025

summarized common errors in treatment planning to be related to

education, documentation, verification, and communication. Clearly these overlap directly with

the 12 topics identified from the authoritative reports.

5. Issues in Low Resourced Settings

5.1 Planning and Integration of Radiotherapy in National Health Programs

The Lancet Oncology Commission1 on expanding global access to RT had five “Calls for

Action” with the first being a target that 80% of countries should have national cancer plans that

include RT by the year 2020. Clearly, if national plans are not in place, the likelihood of any RT

occurring in the country is low. The access to RT problem is most acute in sub-Saharan Africa,

where most countries almost completely lack radiation therapy facilities. The IAEA is working

together with pre-eminent cancer-related health organizations to leverage the effectiveness of

radiation medicine, particularly in LMICs, by integrating it into comprehensive national cancer

programs26

. They, along with the World Health Organization (WHO), have developed a National

Cancer Control Programme/Plan (NCCP) Core Capacity Self-Assessment Tool that has been

used to obtain a simple and quick qualitative overview of national cancer control planning and

on-going activities. The results from 50 member states highlight specific areas where WHO,

IAEA and partners could strengthen collaboration with countries to leverage on-going

interventions and improve availability of resources. Clearly, cancer plans are essential for RT to

be reasonably organized in a national context.

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5.2 Adequate Facilities

In a systematic review of the published literature, Grover et al27

found 49 articles that addressed

RT capacity in LMICs. They concluded that: (1) there is a dearth of publications on RT therapy

infrastructure in LMICs; (2) based on limited published data, availability of RT resources reflects

the countries’ economic status; (3) the challenges of delivering radiation therapy in LMICs are

multidimensional and include: (a) lack of physical resources, (b) lack of human personnel, and

(c) lack of data. Furthermore, access to existing RT and affordability of care remain large

problems.

The Lancet Oncology Commission report1 demonstrated that by the year 2035 the following

resources would be needed in LMICs to provide equal access to RT globally: (1) 6,300

departments with two-megavoltage RT machines each; (2) 12,600 megavoltage RT machines; (3)

6,300 CT scanners; and (4) 30,000 Radiation Oncologists, 22,100 Medical Physicists and 78,300

Radiation Therapists, all to be trained. The second Call for Action in this report is a target of

increasing RT capacity by 25% by 2025.

5.3 Funding for Up-to-Date Equipment

The most significant RT challenges in LMICs include the quality and quantity of physical

resources, the scarceness of skilled human resources, and the unequal distribution of available

resources1, 27, 28

. The number, age, and quality of machines contribute to suboptimal RT capacity

with many countries relying on machines that are more than 20 years old, which brings their

functionality and reliability into question27, 29

. These issues all relate to a lack of adequate

funding, often based on the lack of appropriate NCCPs.

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5.4 Trained Staff and Local Education and Training Programs for Clinically Qualified Medical

Physicists

Most reports on the availability of radiation oncology personnel and training programs indicate

that there are not enough qualified professional staff to treat the number of patients requiring RT.

The insufficient number of personnel is in part due to the insufficient number of training

programs available locally. In view of the recognized deficiencies in human resources and

financing, the Lancet Oncology Commission’s1 Actions 3 and 4 aim for training 7,500 radiation

oncologists, 6,000 Medical Physicists and 20,000 Radiation Therapists by 2025 and target a $46

billion investment by 2025 to establish RT and training infrastructure in LMICs.

5.5 Resources for Equipment Parts and Qualified Support Staff for Maintaining Complex RT

Equipment

Efficient equipment service and maintenance are key components of continuous operation of an

RT facility. Stories abound of how equipment in LMICs sits idle because of a lack of

maintenance support or a lack of funding for such support30-32

.

5.6 New Departments Often Start de novo in LMICs

When a new radiation therapy facility is developed in a high income country, basic infrastructure

for planning and architectural design is readily available and education and training programs are

in place to train radiation oncology-related professionals. Furthermore, continuing education

programs and certification procedures are available through professional organizations and

certifying bodies. In many LMICs such support is often not available nor can they get much

support from colleagues from nearby centers because often there are no nearby centers. Thus,

training and education is a very significant challenge in these settings. Furthermore, the planning

of new departments is frequently performed by non-radiation oncology specialists who often do

Page 9 of 34

not understand that radiation oncology-related professional staff should be part of the planning

discussions in developing a new RT facility and should be available before the new center opens

(see Programmatic QA in Figure 2). In addition, decisions on equipment specifications are often

taken without input from a medical physicist, leading to the purchase of inadequate equipment or

lack of connectivity to existing systems. Whatever education and training mechanisms are

developed, they should be as close to home as possible to match the training with the nearby

medical/technological environment and to minimize the “brain drain”33

.

6. Considerations for New Facilities or Upgrade of Existing Facilities

In planning for new departments or additional machines in existing departments, the IAEA has

developed some excellent resources2, 34-36

. Crucial to describing the operation of a new radiation

oncology facility are five principal components: (1) facility design and development, (2)

equipment, (3) consumable materials, (4) human resources and (5) procedures. A clear chain of

authority and communication needs to be established early. One of the general concerns in

developing a new cancer program is that decisions are made from the “top down” sometimes

without consultation with the appropriate radiation oncology-related professionals. This has

resulted in significant cost over-runs and time delays. Once the project to commission a RT

facility has been approved, a team of professionals needs to be constituted to manage the project.

If expertise is not available locally, external experts should be consulted. At a minimum, the team

should include qualified: architect, structural engineer, mechanical engineer, electrical engineer,

cost consultant, clinical medical physicist, and radiation oncologist34

. Ideally, key individuals

will be available as part of the planning process, but the full staffing complement should be

available when the center starts patient treatments.

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6.1 Donated Equipment

Resource constraints in LMICs often encourage the consideration of donated medical equipment.

Such donations allow for the surplus from high resource settings to be passed on to low resource

settings; however, if poorly executed, donations could turn into a burden for the recipient,

wasting money, human resources, and with long term implications on the healthcare systems.

Furthermore, the lack of appropriately trained staff could have significant implications for safety

and quality. These issues are of particular significance for the high technology, complex and

expensive equipment used in RT.

The WHO has developed resources on donated equipment including a guidance manual37

. The

following main barriers to effective donation of medical equipment have been identified:

Lack of genuine partnership between donor and recipient

Insufficient appreciation for the challenges of the recipient’s context

Limited standardized inventory of medical equipment in resource constrained settings to

identify needs

Insufficient support for the long term integration of new equipment

Insufficient connectivity between activities of various organizations working on donations

Lack of accountability - no tracking and monitoring of donations and no existing

quantification framework for impact of donations

Insufficient capacity and capacity building programs for recipients

The IOMP working with the AAPM has a joint equipment donation program specifically focused

on equipment associated with radiation medicine. The bottom line, however, is that equipment

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donations are often more of a hindrance than help to LMICs; thus, there needs to be well thought

out plans before embarking on the donation of expensive and complex equipment.

7. Lessons Learned from Past Experience

The seven authoritative reports referred to in the Dunscombe paper20

provide guidance on

delivering safe RT, based on lessons learned from past experience – experience which is

primarily based on high income contexts. The question is what the corresponding risks are in

lower income settings. Table 1 lists the topics of the 12 top most cited recommendations made in

these papers. Based on our national and international experience, our interactions with medical

physicists in both low and high income settings, and published reports, we have estimated a level

of risk in LMIC contexts. While not a precise science, it is a way of raising concerns which we

hope will be useful to the development of RT programs. Brief comments are made on several of

the recommendation categories.

7.1 Training

Insufficient numbers of radiation therapy professionals and inadequate training of existing staff

members are one of the main causes of radiation therapy mis-administrations and inferior quality

treatments. “Education” provides the theoretical knowledge and is usually given through

university programs. “Training” provides the skills to perform specialized tasks. For Medical

Physics activities, training is the “on-the-job” learning usually given through a clinical residency

program. In addition to learning how to perform specific tasks, the prime purposes of education

and training of Medical Physicists is to be able to solve unexpected and unique problems,

combined with providing safe, competent, independent and effective service in the clinical

environment. The specialized training for specific technologies can be quickly outdated with the

evolution of new technologies. Both the IOMP38

and the IAEA39

recommend a postgraduate

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degree in Medical Physics, generally an MSc or equivalent, and clinical training for a period not

less than two years. European and IAEA surveys indicate that the minimum academic education

and clinical training time frame for employment as a hospital medical physicist varies between

three and nine years, with an average of six years39

.

According to Datta et al28

, 55 LMICs, representing 358 million people, have no access to RT.

Clearly, these 55 countries have no Medical Physics training programs. Even in some countries

with RT, education and training are non-existent or at an embryonic stage. Thus, there is a

“bootstrapping” problem of how to provide education and training without existing experienced

university and clinical staff to lead the necessary education and training programs. There are

several considerations in this context. For development of new facilities or expansion of existing

facilities in LMICs, a multidimensional approach can be used whereby the national government,

international government or non-government agencies, not-for-profit volunteer organizations as

well as foreign hospitals and universities work in partnership to establish or expand existing

programs. Organizations like the IAEA are heavily involved in support of infrastructure

enhancement in low income settings29, 40-42

. Member states of the IAEA can apply for assistance

through their country projects since development of RT programs usually include human

resource improvement components of expert missions, scientific visits, fellowships, and national

courses or workshops40

. Regional and interregional training courses and projects are also

available. In addition, there are multiple volunteer and non-profit organizations in support of

infrastructure and educational development both at the broader and grassroots levels. Examples

include International Cancer Experts Corps (ICEC) (www.ICECcancer.org ) and Medical

Physicists Without Borders (MPWB) (www.mpwb.org ). A link in the latter website

(http://www.mpwb.org/page-18070 ) provides further hyperlinks to multiple organizations in

support of radiation therapy activities in low-to-middle income settings. Novel solutions to

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education and training issues are possible through collaboration between international

organizations, local governments, and regional organizations29

.

7.2 Staffing

Inadequate resources mean that multiple facets of healthcare are underfinanced including

equipment and staff. Staffing recommendations have been provided by various organizations.

Many of the original staffing recommendations were based primarily on patient numbers35

. A

European survey indicated that the guidelines across Europe are far from uniform and the metrics

used for capital and human resources are variable43

. Recent, more advanced staffing algorithms

are activity-based and account for patient workload, technology, techniques, procedures and

infrastructure so that they are more relevant for the reality in local circumstances44-46

and are

applicable to environments that range from 2-D RT to intensity modulation with image guidance,

motion management and 4-D considerations. The IAEA algorithm is accompanied by a

spreadsheet calculator so that it can be used as a practical tool for determining staffing levels46

.

7.3 Documentation/Standard Operating Procedures

The literature shows that 70%-80% of incidents (defined as “an unwanted or unexpected change

from a normal system behavior that causes or has the potential to cause an adverse effect to

persons or equipment”) are primarily caused by either lack of, inadequate, or failure to follow

standard procedures18, 47

. Thorough documentation is essential along with the mandate to follow

procedures as documented. Unfortunately, when staffing levels are constrained, documentation is

one of the first things to be compromised. Considerations for reducing treatment uncertainties

include the implementation of clear policies, guidelines and procedures, good documentation of

the policies and procedures as well as the results of acceptance, commissioning and QC tests6. If

the acceptance, commissioning and QC procedures are not documented, then it is effectively

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equivalent to not having performed them at all. If there is staff turnover, the new incoming staff

member will not know what procedures have occurred to commission the equipment. If there are

no protocols for patient procedures, it will be difficult to maintain consistency from one patient to

the next. Stringent QA review can have a positive impact on every day clinical practice48

. A

policies and procedures manual should be available in every department and should be reviewed

and updated annually.

7.4 Incident Learning

The Institute of Medicine’s report on “To Err is Human: Building a Safer Health System”49

was

one of the first reports to overtly emphasize that we should learn from our (or others’) mistakes.

Since the year 2000, much activity and publicity has been given on the development of incident

learning systems and various examples have shown how the error rate has been reduced as a

result of openly disclosing errors and learning from past mistakes18, 47, 50

. However, open

disclosure of errors and a well-documented incident learning process requires a working

environment of trust and agreement that patient treatment errors are not the problem of

individuals but they are a result of an inadequate quality management system. Unfortunately, in

the past and in some cultural environments, there is a tendency to want to blame individuals for

patient-related treatment errors. In some cultural contexts, the “no blame” concepts are very

difficult to accept and implement. However, without an overt acceptance of an incident learning

mentality, the error rates are not likely to decrease.

The IAEA has developed a web based user system, SAFety in Radiation ONcology (SAFRON)

for improving the safety and quality of patient care in radiation therapy by sharing knowledge

about incidents and near incidents. SAFRON allows radiotherapy centers to contribute incidents

and near misses to an international learning system, allowing the participating centers to share

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and receive information on incidents and near misses. By pooling information on the incidents,

causality and corrective actions, radiotherapy facilities can develop a safety system that can

prevent or reduce the likelihood of an incident occurring at their facility.

7.5 Communication/Questioning

A well-developed safety culture includes an atmosphere of open and non-threatening

communication. The emphasis should be on “no question is a dumb question” so that all staff will

readily ask questions of their peers, superiors and subordinates without feeling intimidated. One

study performed a cross-cultural survey of medical residents to determine perceived barriers in

questioning and challenging authority51

. The conclusion was that organizational and professional

culture may be as important, if not more so, than national culture to encourage "speaking up".

Residents (and staff) should be encouraged to overcome barriers to challenging their colleagues,

and training programs should foster improved relationships and communication between trainers

and trainees.

7.6 Checklists

The fourth most effective risk mitigation strategy proposed by the Institute for Safe Medication

Practices (ISMP) is the use of reminders, double checks and checklists52

. In WHO’s

Radiotherapy Risk Profile9 one of the suggested risk reduction interventions for all stages of the

radiation therapy process includes information transfer with redundancy. However, the challenge

of checklists is the potential for automaticity20

whereby procedures are repeated by rote without

careful thought. This results in the risk of copying errors. This automaticity is a significant

concern in busy understaffed departments as might occur in lower resourced environments. Thus,

an emphasis should be placed on developing policies and procedures that are simultaneously

effective and efficient with appropriate redundancies and checklists.

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7.7 Quality Control/Preventative Maintenance

Numerous reports have been written by national and international organizations on QC protocols

for RT-related technologies and procedures, many of which are available on-line53

. Vendors

provide detailed documentation on preventative maintenance procedures. The trend is towards

facility-unique QC programs through the use of failure modes and effects analysis (FMEA)

whereby risk assessment is made on a local basis; however, this is still an evolving process and

has not yet been practically implemented in a low resourced RT environment22

.

7.8 Dosimetric Audit

Dosimetric audits for low income settings have been in use since 1969 by the IAEA/WHO and

have proven to be an invaluable guide for identifying errors and reducing uncertainties54

. These

audits have improved the practice and accuracy of dosimetry in a wide range of RT centers and

have helped in maintaining these levels over time6. Over the years the audits have evolved from

mailed thermoluminescent dosimetry (TLD) measurements under reference conditions to non-

reference conditions55

and then to on-site end-to-end tests56

. These audits have been found so

useful that the IAEA, in its report on Accuracy Requirements and Uncertainties in Radiotherapy6

made the recommendation that “An independent dosimetry audit should be performed for every

new installation that is about to embark on radiation treatments. In addition, regular (e.g. annual)

audits should be performed using remote services or on-site visits (or equivalent).”

The IAEA audit program has been extended to include a review of the total RT care process

including observations concerning buildings, human resources, treatment and dosimetry

equipment, comprehensive patient care, adherence to standards of radiation protection and

establishment of quality assurance program, education and research57

. The quality assurance team

for radiation oncology (QUATRO) program includes an on-site team visit with a radiation

oncologist, medical physicist, radiation therapist, and a fourth member with special competencies

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such as a radiation protection officer from the visited country58

. The QUATRO audits have

proved to be a valuable tool for identifying weaknesses in infrastructure, human resources and

procedures in RT centers and have been applied primarily to LMICs.

7.10 Minimizing Interruptions

Interruptions and distractions have been shown to result in significant treatment safety concerns

in different clinical contexts59

60

. General recommendations include “no interruption zones” and

educational programs on risks associated with untimely interruptions. Other factors that were

identified as contributing to errors included cluttered therapy workstations containing multiple

computer monitors as components of various aspects of treatment, and staff traffic patterns that

do not shield the radiation therapist from extraneous conversations and interruptions21

. These

issues could be of additional concern in low income environments with non-optimum ergonomic

settings and understaffed conditions.

7.12 Safety Culture

A patient safety culture is referred to as the employees' shared beliefs, values and attitudes

regarding patient safety in an organization, all of which are reflected in the daily operational

clinical practice. A recent survey61

identified 7 subcultures of a patient safety culture: (a)

leadership, (b) teamwork, (c) evidence-based, (d) communication, (e) learning, (f) just, and (g)

patient-centered. Successful patient error reporting programs are dependent on the level of

importance given by management and it is this level of importance that determines the

organizational culture62

. An organizational culture that seeks to prevent patient harm is

characterized by effective communication, shared values about the importance of safety, and the

presence of systems that help the organization learn from errors and prevent them from occurring.

Reason63

took lessons from industry to make sense of the high number of adverse events in health

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care. He indicated that only a systems approach (as opposed to the “person” approach of blaming

an individual) will create a safer health-care culture because it is easier to change the conditions

people work in than change human actions. When a system fails, the immediate question should

be why it failed rather than who caused it to fail, e.g., which safeguards failed? Reason created

the “Swiss cheese” model64

to explain how faults in the different layers of the system can lead to

accidents/mistakes/incidents. According to the Institute of Medicine49

, “the biggest challenge to

moving toward a safer health system is changing the culture from one of blaming individuals for

errors to one in which errors are not treated as personal failures, but as opportunities to improve

the system and prevent harm.”

One manifestation of a patient safety culture is the implementation of a dedicated formal quality

assurance committee consisting of a multidisciplinary team (e.g., radiation oncologists, medical

physicists, medical dosimetrists, and radiation therapists) that meets regularly and serves as

liaison with leadership and hospital-wide safety committees45

.

In summary, a safety culture consists of an environment where patient safety is addressed as (1) a

priority from top management and down, (2) no blame is assigned to (patient) errors - errors are a

systems problem, (3) open communication at all levels is encouraged including an attitude of no

question is too dumb, (4) an error reporting system is in place so that lessons can be learned from

errors, and (5) team work is encouraged, with all team members having equal and important

roles. Unfortunately, different societal/cultural contexts may make a safety culture difficult to

implement; however, it is lessons from transformative organizations that have encouraged the

patient safety culture as being a significant approach to minimizing patient adverse events.

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8. Broad Quality and Safety Matters for Low-Resourced Settings

The specific issues for low resourced settings are not all that different from issues that existed

within high resourced settings a number of years ago, with high resourced settings having moved

forward in the meantime. Hopefully the high-resourced contexts can provide guidance and a

higher rate of implementation for lower-resourced circumstances. The broad issues of significant

concern include: (1) support from upper level management and encouragement for quality and

safety considerations along with the development of a QA culture, (2) concern about the lack of

professional recognition of medical physicists, (3) lack of educational infrastructure to educate

and train locally, (4) appropriate budgets especially for radiation technology service and

maintenance, (5) development and recording of quality metrics, and (6) support through national

and international initiatives.

8.1 Administrative Support

Quality and safety will receive much greater emphasis in an environment where they are actively

supported and promoted by senior management. The first general conclusion from a meeting

entitled “Safety in Radiation Therapy: A Call to Action” held in Miami, Florida in June 2010,

which was sponsored by the AAPM and ASTRO and hosted by 13 North American related

organizations, was that “policies and procedures to improve patient safety are successful only if

senior management emphasizes their importance. At the institutional level, safety must be

supported and encouraged by the institution's board of directors and senior management. At the

level of individual services, such as radiation oncology, the physician director, departmental

administrator, chief physicist, and chief therapist must emphasize the importance of patient

safety.”21

In some contexts this requires significant cultural shifts. However, the first step to

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transformation is recognition of the issue, the second step is open discussion and the third step is

implementation.

8.2 Professional Recognition of Medical Physicists

The profession of medical physicist is often not understood, primarily as a result its highly

specialized nature as well as its minimal presence in low-income countries65

,66

. High income

countries have about 15 to 20 medical physicists per million population while in developing

countries there may be 1 to 5 per million and in many low-income countries there are none. In

numerous countries, where the profession is not formally recognized, medical physicists are often

recruited and employed under other designations such as technician, biomedical engineer, or

research assistant. Such inappropriate recognition has a direct impact on their socio-economic

and professional status in health-care teams65

. The Bonn Call-for-Action Joint Position Statement

by the IAEA and WHO concluded that recognizing medical physics as a skilled, independent

health care profession, is a key step to strengthening radiation safety culture in health care67

.

8.3 Educational Infrastructure

The Lancet Oncology Commission report1 called for new approaches to train RT professionals

globally, with the creation of new core curricula, innovative learning methods, and international

credentialing to expand the RT workforce. Training should become part of the mandate of each

national RT center to self-propagate the required skills, enabling national expansion of cancer

therapies and providing the ability to replace staff as they leave or are recruited out of country.

Potential tools, techniques and procedures that can aid education and training in resource limited

environments include: (1) e-learning68-71

, (2) e-mentoring/e-rounds72

(e.g.,

http://chartrounds.com/), (3) collaborative course development/education/training39, 73

, and (4)

courses provided by national/international organizations74

.

Page 21 of 34

8.4 Partnerships and Peer-to-Peer Collaborations

While the growing cancer divide is becoming increasingly recognized1, 26, 28, 30, 40, 75

the solution

in support of reducing the divide is very complex since it involves multiple social, economic,

cultural and political facets. , Approaches to improving the availability of safe and effective RT

in LMICs, will require collaboration between multiple organizations including local

governments, regional, international as well as non-government organizations40, 41

. Advanced and

coordinated planning by governments, professional and other not-for-profit volunteer

organizations will be essential to the success of these initiatives. The number of organizations

involved is significant as indicated by the 34 examples listed in Table 2. Thus, coordination will

be crucial.

Regarding the involvement of professionals in LMIC contexts, the International Cancer Experts

Corps (ICEC) proposes an altruistic service along with a philosophy that global health becomes

an integral part of the spectrum of academic and professional careers with a goal that 20% of time

be devoted to this activity. Students and residents can also consider this part of their community

service and altruistic efforts76

.

9. Summary and Conclusions

The radiation treatment process is complex involving sophisticated high technology equipment

and multiple professionals including radiation oncologists, medical physicists and radiation

therapists. The complexity, sophistication, high up-front costs and a lack of trained professional

staff have been a deterrent for implementation of RT in many LMICs. However, with appropriate

political and organizational will these barriers can be overcome and indeed are beneficial to both

the healthcare of individuals as well as to a nation’s economic status. The quality, safety and

benefits of radiation treatment are strongly dependent on the quality and safety culture. Strong

Page 22 of 34

partnerships between multiple organizations and countries will enhance the development of safe

and resource-appropriate strategies for advancing the radiation treatment process.

Page 23 of 34

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Figure Captions

Figure 1. Number of publications from PubMed search done in January 2016: (a) with the words

“global” and “cancer” in the title; (b) with the words “global” and (“radiotherapy” or “radiation

therapy” or “radiation oncology”) in the title.

Figure 2. Elements of quality assurance (QA) activities occur at both the programmatic and

individual patient levels. (Adapted from an unpublished figure from M. Milosevic.)

Tables

Table 1. Top cited recommendations20

for patient safety and estimated level of concern in low-

to-middle income countries.

Recommendation Estimated risk level in LMICs * Very low risk

***** Very high risk

Training *****

Staffing *****

Documentation/SOP ***

Incident learning ***

Communication/questioning ***

Check lists ***

QC/PM ****

Dosimetric audit ****

Accreditation ***

Minimizing interruptions ****

Prospective risk assessment **

Safety culture ***

Page 30 of 34

Table 2. Organizations in support of enriching RT capabilities in LMICs.

Organization Web Link Comment

1 Above and Beyond

Cancer

https://aboveandbeyondcancer.org

/

A public charity with a mission to

elevate the lives of those touched

by cancer. Along with getting to

mountaintops, they are devoted to

advocacy and leading an example

for healthy living and cancer

prevention in their communities.

2 Academic Model

Providing Access to

Healthcare (AMPATH)

www.ampathkenya.org Consortium of North American

academic health centers led by

Indiana University working in

partnership with the Government

of Kenya.

3 African Organization for

Research and Training in

Cancer (AORTC)

www.aortic-africa.org AORTC is dedicated to the

promotion of cancer control in

Africa.

4 Alliance des Ligues

Francophones Africaines

& Mediteraneennes

(ALIAM ) ("Alliance of

African & Mediteranean

French Speaking

Leagues")

www.aliam.org ALIAM was founded by common

agreement between the

representatives of multiple

associations from multiple

Francophone countries to fight

against cancer.

5 American Association of

Physicists in Medicine

(AAPM)

www.AAPM.org Through various international

committees and on-line

educational resources for

developing countries.

6 American Society for

Radiation Oncology

(ASTRO)

www.ASTRO.org Through its International

Education Subcommittee (IES)

7 American Society of

Radiological

Technologists Foundation

http://foundation.asrt.org/ It invests money raised in medical

imaging technologists and

radiation therapists who want to

deliver the safest and highest-

quality patient care possible

around the world and more.

8 Association

Cancérologues sans

Frontières (“Oncologists

Without Borders”)

www.cancerologuesansfrontieres.

com

"Oncologists Without Borders"

was created in 1998 to promote

oncology in developing countries.

It is a non-profit organization.

9 BOTSwana Oncology

Global Outreach Program

(BOTSOGO)

www.botsogo.org Works to improve access to quality

cancer care in Botswana

Page 31 of 34

1

0

ChartRounds www.chartrounds.com ChartRounds brings together

academic disease site specialists

from leading cancer treatment

institutions and connects them

with the Chartrounds network of

over 1300 physicians and medical

physicists.

1

1

Cure4kids www.cure4kids.org Cure4Kids is an online resource

for healthcare professionals

dedicated to enhancing the care of

children who have cancer and

other life-threatening diseases in

countries around the globe.

1

2

European Society for

Radiotherapy and

Oncology

www.estro.org Advances all aspects of Radiation

Oncology through a range of

activities, including teaching

courses in Europe and beyond.

1

3

Foundation for Cancer

Care in Tanzania

www.tanzaniacancercare.org The Foundation for Cancer Care in

Tanzania enhances cancer care to

improve the lives of the citizens of

Tanzania through education,

programs for prevention and

screening, and services providing

treatment and palliation.

1

4

Global Oncology www.globalonc.org Global Oncology is a volunteer

community of physicians,

scientists, designers, engineers,

public health experts, policy

makers, nurses, lawyers, students,

and other professionals working in

teams to help people throughout

the world who are treating cancer

and its related pain.

1

5

Global RT http://globalrt.org GlobalRT is a movement to turn

radiotherapy into a global health

priority. It provides a virtual

platform for education, exchange,

and action around the essential

nature of radiotherapy for cancer

care.

1

6

International Agency for

Research on Cancer

(IARC)

www.iarc.fr IARC is the specialized cancer

agency of the World Health

Organization to promote

international collaboration in

cancer research.

1

7

International Atomic

Energy Agency (IAEA)

(a) Programme of Action

for Cancer Therapy

(PACT)

http://cancer.iaea.org/mission.asp

PACT strives for global

partnerships to confront the cancer

crisis in developing countries, with

Page 32 of 34

(b) Human Health

Campus

(c) Technical Cooperation

https://nucleus.iaea.org/HHW/

https://www.iaea.org/technicalcoo

peration/

WHO, and the Joint Programme

on Cancer Control established in

2009.

Online information resource for

health professionals working in

nuclear medicine, radiation

oncology, medical physics, and

nutrition.

Supports human resource capacity

building, networking, knowledge

sharing, partnership facilitation

and procurement of equipment.

1

8

International Campaign

for Establishment and

Development of Oncology

Centers (ICEDOC)

www.icedoc.org A non-governmental organization

which aims to lessen the human

suffering from cancer all over the

world.

1

9

International Cancer

Experts Corps (ICEC)

www.iceccancer.org "Partnering to transform global

cancer care"

2

0

International Cancer

Research Partnership

(ICRP)

https://www.icrpartnership.org/ ICRP is a unique alliance of cancer

organizations working together to

enhance global collaboration and

strategic coordination of research.

2

1

International Network for

Cancer Treatment and

Research (INCTR)

www.inctr.org A not-for-profit organization

dedicated to helping build capacity

for cancer research and treatment

in developing countries.

2

2

International Organization

for Medical Physics

(IOMP)

www.iomp.org Advances medical physics practice

worldwide by disseminating

scientific and technical

information, fostering educational

and professional development of

medical physics and promoting the

highest quality medical services

for patients.

2

3

Medical Physicists

Without Borders (MPWB)

www.mpwb.org MPWB is a not for profit,

membership-based volunteer

organization to support the

effective and safe use of physics

and technologies in medicine

through advising, training,

demonstrating and/or participating

in medical physics-related

activities, especially in LMICs.

2

4

Mephida www.okonmedphys.com Mephida is an independent NGO

with a novel approach to improve

cancer care in Africa through

medical physics services.

2

5

Physicien Médical Sans

Frontière

www.pmsf.asso.fr French-based non-government

organization with expertise in

Medical Physics and devoted to

Page 33 of 34

the fight against cancer.

2

6

Pink Ribbon Red Ribbon http://pinkribbonredribbon.org A global organization powered by

partnerships, Pink Ribbon Red

Ribbon saves lives from cancer in

countries where the need is

greatest.

2

7

Rad-Aid www.rad-aid.org Its mission is to improve and

optimize access to medical

imaging and radiology in poor and

developing regions of the world

for increasing radiology’s

contribution to global public health

initiatives and patient care.

2

8

Radiating Hope www.radiatinghope.org Volunteer-run, mountain climbing,

cancer-cure focused, non-profit

organization with the mission of

improving cancer care, specifically

radiation oncology care, around

the globe.

2

9

Radiation Safety Without

Borders

https://hps.org/documents/rswb_fl

yer.pdf

An initiative of the Health Physics

Society to provide peer support to

radiation safety professionals in

developing countries.

3

0

TreatSafely Foundation www.treatsafely.org A free, peer-to-peer training and

sharing site that hosts clinically

practical, very useful videos and

documents.

3

1

Union for International

Control of Cancer (UICC)

www.uicc.org The UICC is a membership-based

organization which unites the

cancer community to reduce the

global cancer burden, to promote

greater equity, and to integrate

cancer control into the world

health and development agenda.

3

2

World Cancer Research

Fund International

(WCRF)

www.wcrf.org WCRF is the world’s leading

authority on the link between diet,

weight, physical activity and

cancer. It is a not-for-profit

organization that leads and unifies

a network of cancer prevention

charities with a global reach.

3

3

World Health

Organization (WHO) -

Cancer

www.who.int/cancer/en/ This is the component of the WHO

website devoted to cancer.

3

4

Worldwide Cancer

Research (WCR)

www.worldwidecancerresearch.or

g

WCR is a charity which funds

research anywhere in the world.

Page 34 of 34