Keywords

1 Introduction

Primum non nocere, ‘first, do no harm’, is the underlying tenet of healthcare. The vast majority of healthcare practitioners do not go to work intending to do harm; however, no individual, machine or system is infallible and every individual does things that could, or do, result in harm. Errors are inevitable. By knowing what happens and why, it is possible to put systems into place to minimize frequency, maximize detection and minimize impact. One way to detect incidents, including near misses, is by using a dedicated incident reporting system. An incident reporting system collects data, analyses causes, classifies events, develops solutions and advocates their use.

Incident reporting is a way to detect real or potential harm. A well-constructed and utilized incident reporting system is able to detect near misses, which in other high-risk industries account for most of the reported incidents. Incident reporting is well established in many high-risk industries, such as aviation, oil, gas, nuclear power, and rail; and has been shown to improve safety and reduce adverse events [32]. Although incident reporting in healthcare has been in existence for decades, its routine use as a quality improvement and safety tool is less well accepted, despite this being a core component to improve patient safety [7].

Examples of safety improvements in healthcare that have been brought about by the use of incident reporting are the routine use of pulse oximetry and capnography in general anesthesia [28]. Perhaps the most significant benefit is an increased awareness of risk and safety, which is not easily measured.

2 What Are Incidents and Why Do They Happen

A patient safety incident, or incident, is defined as ‘an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient’ [31]. Incidents in healthcare are like icebergs: the visible tips are the incidents that result in harm; the majority, equivalent to the submerged parts of the icebergs, are near misses i.e. incidents that did not reach the patient.

Most, if not all, incidents are the result of a sequence of events; but each event in isolation would not have resulted in harm. A near miss is when the combination of circumstances results in the potential harm being detected and mitigated before an adverse outcome occurs. This scenario is well described by Reason’s Swiss cheese model (Fig. 11.1) [25, 26]. Whilst individual actions may have a significant impact on safety, it is the culture and working environment that affect the thinking and behavior of the practitioners, and encourage or constrain safe practice.

Fig. 11.1
figure 1

Swiss cheese model. The slices of cheese represent the barriers in place to prevent harm but no preventative strategy is totally reliable. The holes in the cheese represent deficiencies in the barriers. By having several preventative strategies in place it is more likely that a potential harm will be detected and mitigated before it reaches the patient. Occasionally, however, the holes line up and the patient is harmed. Incident reports can be used to analyze these incidents and the knowledge gained can be used to strengthen the defences (Reproduced with adaptation from ‘Reason J (2000) Human error: models and management. BMJ 320(7237):768–70’, with permission from the BMJ Publishing Group Ltd)

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3 Why Report Incidents

Errors are prevalent in healthcare. For example, up to 18,000 Australian patients died from healthcare mistakes and over 16 % of admissions were associated with an adverse event [28]. The Institute of Medicine in the USA published ‘To err is human’ [11], in which it was reported that between 44,000 and 98,000 Americans died each year as a result of preventable medical errors, more than the number of deaths from common malignancies such as breast cancer. A key finding of this report is that most of the harm was due to system issues rather than bad or incompetent practitioners or other staff. The report recommended that the American government should ‘… develop, disseminate, and evaluate tools for identifying and analyzing errors …’; and ‘… identify and learn from errors by (1) developing a nationwide public mandatory reporting system and (2) encouraging healthcare organizations and practitioners to develop and participate in voluntary reporting systems …’. This report further commented that ‘… (voluntary) systems can focus on a much broader set of errors, mainly on those that do no harm or result in minimal harm, thus helping to detect the system weaknesses that should be fixed before the occurrence of any serious harm, thereby providing rich information to the healthcare organizations in support of their quality improvement efforts…’.

In the United Kingdom approximately 900,000 incidents are reported within the National Health Service (NHS) every year and approximately 2,000 of these result in death [15]. These figures demonstrate that error is common in healthcare. In order to understand errors, reduce incidents and improve patient safety, it is important to capture the data on all incidents including near misses, rather than just those resulting in harm. Incident reporting is more likely to capture this type of data than other methods of studying patient safety, errors and incidents.

The practice of radiology and medical imaging can be reviewed and audited more easily than other specialties where exposures, images, reports, and other data produced and recorded. However, the scope of this data is very limited because the vast majority of incidents including all near misses and much of the information about the underlying causes are not captured. In order to obtain this information, including the data that enables the identification of the underlying causes, a more comprehensive approach such as an incident reporting system is needed.

4 Components of an Incident Reporting System

The National Patient Safety Agency (NPSA) in the United Kingdom, published ‘Seven Steps to Patient Safety’ [16, 17] and describes the following elements as the ‘circle of safety’:

  1. 1.

    Reporting;

  2. 2.

    Analysis;

  3. 3.

    Solution development;

  4. 4.

    Implementation;

  5. 5.

    Audit and monitoring;

  6. 6.

    Feedback; and

  7. 7.

    Reporting.

4.1 Reporting System

A good incident reporting system should: be independent, trustworthy, relevant, non-punitive, accessible to all, and user-friendly; encourage entry of honest, thoughtful narrative and data; and have peer involvement. The design must balance the need for adequate information against the time required. Unfortunately, under reporting is widespread [18, 27].

4.1.1 Scope

An incident reporting system for radiology and medical imaging includes all the events along the patient journey. A reportable event is not limited to the acquisition and interpretation of images or performance of procedures, i.e. events relating to patient preparation, referral communication, result delivery etc. should also be recorded. These events can occur outside a radiology department. In a British study of anesthetic equipment failure, nine incidents occurred in remote sites, mostly in radiology [6]. These anesthetic incidents should also be part of a radiology incident database.

4.1.2 Common Taxonomy

A common language for patient safety to be used in the classification, analysis and dissemination of the findings facilitates the sharing of data and the lessons learned [28]. The World Health Organization (WHO) has developed a conceptual framework [31] that is currently being developed into a classification. Common terminology enables computer-aided data analysis. This is important when analyzing large volumes of data and detecting trends [14].

4.1.3 WHO Classification Framework

A diagram illustrating the WHO conceptual framework for the classification of patient safety is shown in Fig. 11.2 [38]. For any incident there are usually several contributing factors or hazards, some of which may be mitigated by actions taken to reduce risk. The outcome, whether a near miss or harm occurring to the patient or organization will depend on when the incident is detected and the effectiveness of the mitigating and ameliorating factors. Information from all stages is useful in developing strategies and tools to prevent further incidents.

Fig. 11.2
figure 2

The WHO Conceptual Framework for the International Classification for Patient Safety. This diagram shows the stages in the development and detection of incidents. This information, when captured in an incident report, can be used to analyze, classify and group incidents and devise strategies to prevent, detect and mitigate further occurrences of incidents (Reproduced from ‘Chapter 2, page 8 of Conceptual Framework for the International Classification for Patient Safety (2009) WHO, Geneva’ with permission from the World Health Organization)

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Some examples of the contributing factors to a misidentification incident (e.g. procedure performed on a wrong patient) could include: poor communication between staff, wrong name on request form, two patients with the same or similar name, and inability to communicate due to coma, a minor, dementia or language barrier etc. Patient characteristics are demographic data, reason(s) for seeking care and the primary diagnosis. Actions taken to reduce the risk could include a robust patient identification policy, e.g. asking the patient to actively identify himself or herself rather than asking ‘Are you John Smith?’ An example of detection and mitigating factors is the crosschecking of patient identification before a procedure. These are secondary and tertiary prevention strategies.

Patient outcomes could either be a near miss, a delay in receiving the correct procedure, or receiving an unnecessary procedure and/or radiation exposure. Organizational outcomes could include root cause analysis leading to sanction or review for incorrectly irradiating a patient. Ameliorating actions could include an apology to the patient and treatment of any harm sustained. Actions taken to reduce risk after the event could be the development of a robust patient identification policy and the education of staff and patients to ensure proper implementation.

4.1.4 Data Fields

The following fields are suggested as the essential data required for a reporting system [21]:

  1. 1.

    The discovery:

    1. (a)

      Who discovered the incident

    2. (b)

      How was it discovered

  2. 2.

    The event:

    1. (a)

      What happened: type of event and narrative

    2. (b)

      Where in the care process did the event occur and at what stage was it discovered

    3. (c)

      When did it occur

    4. (d)

      Who was involved (type of staff, not necessarily named)

    5. (e)

      Why did it happen: primary and secondary causes

    6. (f)

      Risk assessment: severity, probability and preventability

    7. (g)

      Narrative of the event including the contributing factors and ancillary information

    8. (h)

      Product information

    9. (i)

      Patient demographics, diagnosis, procedure and co-morbidities

The other important elements are the contributing and mitigating factors, consequences, modifiers and prevention strategies.

4.1.5 Paper Or Electronic Forms

Traditional incident reports have been paper documents that needed to be read, collated, classified and analyzed. This was time-consuming and prone to problems, especially when interpreting illegible handwriting. Whilst there is a role for this format in those settings without internet access, its use is becoming less common.

Electronic or on-line report filing is common in healthcare. Electronic data entry has many advantages, not least computer-aided analysis, classification and data search. Another advantage is the ability to pose questions that are specific to the type of incident. For example, different information would be required for a patient identification incident compared with an equipment failure incident. On-line reporting allows incidents to be reported from anywhere and at any time. Making incident reporting easy and contemporaneous is important.

As with all computer-based processes, stringent attention to data security including encryption before transmission and storage, and data back up/duplication to safeguard against system failure are required. The ability to use the reporting system on a variety of platforms and software is critical.

The use of ‘pick-lists’ and forcing functions ensure the essential data are entered. An ability to enter free narrative text is important [18], because this can be an important source of information about what happened, the events before the incident, what actions reduced the harm and what actions could potentially have prevented the incident. A system may be custom-designed or an existing proven program may be modified to meet the requirements of radiology and medical imaging. One such programme is the Advanced Incident Management System AIMS™ software [2], which is used for the Radiology Event Register (RaER) database [24].

In some industries such as aviation, reports can be filed by telephone initially. A final written documentation is still needed and this can be done by fax. Staffing a call centre increases cost but this option increases accessibility especially if other means are not readily available.

4.1.6 A Collaborative Or Stand-Alone Database

An incident reporting system for radiology and medical imaging can be part of a large collaborative international, national or hospital-wide reporting system or a stand-alone, dedicated database.

A national database such as the National Reporting and Learning System (NRLS) in the United Kingdom obtains data directly from the local risk management systems (LRMS) used in hospitals and other healthcare organizations. Data is entered once and is available in two systems. It is possible to report incidents directly to the NRLS, including by patients and carers. The data is shared with other organizations when the incidents are relevant, e.g. incidents involving medical devices or drug reactions. Such system has the benefit of single data entry from any field of healthcare but the data unique to radiology may not be specifically recorded. Vendors of risk management systems are able to include relevant datasets in their products so they can interact with larger systems [16, 17].

An international incident reporting model for radiology and medical imaging is the RaER, a peer-led and radiology-specific database that collects data from Australia and New Zealand [24]. Such a system is not a substitute for reporting incidents into a hospital database. Ideally data should be available in both systems after a single entry.

Whilst a stand-alone, facility-based reporting system can collect data about the common problems, it may not detect trends or support analysis. Since many different incidents occur infrequently, it is important to share and aggregate this data for an analysis of the risks and trends, as is the case for adverse drug reactions.

An incident collection agency must operate independently from an enforcement authority, maintain patient confidentiality, comply with legal requirements and preferably be endorsed by the stakeholders. Local access to a reporting system is essential as this facilitates the timely collection of data. The dispersion of reports amongst the different systems, e.g. hospital, national, radiation regulatory body etc. should be avoided [30].

4.1.7 Voluntary Or Mandatory Reporting

Ideally all incidents should be recorded in an incident reporting database; in reality many are not [18, 27]. As voluntary reporting has varying degrees of success, the reporting of serious incidents is often mandated and is a legal requirement. In aviation the reporting of serious incidents is required by law. Whilst this is also meant to be the case in healthcare, e.g. in the notification of wrong side, wrong site and wrong patient operations etc., it does not always occur. There are many reasons why this may not happen. Improving the safety culture and accepting incident reporting increase reporting rates. The ability of a system to accept voluntary reports about any aspect of patient care or any other perceived risk within an organization will give the greatest opportunity to detect potential threats and vulnerabilities within systems and will improve patient safety [21].

4.1.8 Known, Confidential Or Anonymous Reporting

Reporting an incident can cause anxiety about possible backlash from colleagues, employers or other organizations. In some cases reports have been used punitively [27]. The person reporting an incident may fear being blamed for doing something wrong, even if the actions were not deliberate; of being made a scapegoat i.e. blame the person rather than fix the system; of backlash from other individuals or organizations who may be scrutinized or found to be imperfect as a result of the report. Protecting the identity of the person reporting an incident is therefore critical. This could be achieved by confidential reporting either by legislation or permitting anonymous reporting of incidents [29].

Confidentiality has a clear advantage: the person who reported an incident can be asked to provide more information. This method is used in aviation and in the NRLS. In aviation the accident investigation and regulatory bodies are separate entities. This is important, as the investigating body cannot have a punitive role. Legislation describes what can and cannot be disclosed to others outside the investigating authority.

If an organization does not have a just culture i.e. one that is based on fairness and justice, and one that seeks to balance the need to learn from mistakes and the need to take disciplinary action [38]; there may be hesitation to provide full and frank details or to report at all. With confidential reporting, individuals are accountable for their actions. Whilst confidential reporting provides the best opportunity to gather extra information this is only possible where a fair and just culture exists and there is clear protection from punitive action be it from litigation, employers or colleagues.

The extent to which an individual’s identity is kept confidential varies. In some systems the reporter’s managers or those able to influence the reporter’s career or employment will not see the report. In others the report is sent to the reporter’s line manager. In those practices without a robust just culture this will inhibit reporting, as staff will fear punitive actions.

An anonymous reporting system gives the reporter an added layer of protection: without detailed forensic analysis of IP address, fax number or handwriting it is not possible to know the reporter’s identity. There are, however, major disadvantages, in particular more detailed information cannot be obtained. Fears of malicious reporting have been raised if the reporter is neither identifiable nor accountable. This has not been the experience in reviewing and analyzing the reports in the RaER database or in other large professionally based reporting systems [36].

Regardless of the chosen method, any identifying material about staff and patient must be removed before a report is analyzed, sent to another party, published as a safety alert or used in any other way.

4.1.9 Who Should and Who Does Report

All healthcare stakeholders need to be able to report incidents (NPSA 2004): not just clinical staff such as doctors, nurses and radiographers but also clerical and other non-clinical staff. Patients and carers also need to be able to report incidents: these may be gathered by feedback surveys or correspondence to the healthcare facility or patient advocates.

The reporting rates by nurses are typically higher than doctors [13, 27]. This is probably a reflection of the differences in training and culture. This does, however, lead to bias in the type of incidents reported and data recorded [27]. This is particularly true in anonymous reporting, as there is no way of getting more information to fill in the gaps and explore the causative factors.

4.1.10 Accountability

Whichever system is used to collect data individuals must be accountable for their actions [17]. This needs to be done in a way that does not deter reporting or learning from incidents. This can be a difficult outcome to achieve, hence the need for a just culture.

4.1.11 Ethics

Incident reporting is a quality improvement activity and in many jurisdictions is subject to statutory immunity. Open disclosure is good practice and is best performed independently of the report: anonymous reports cannot always be linked to individual patients.

4.1.12 Resources

Funding is necessary to establish and maintain the infrastructure for the database, including the collection, analysis and classification of data; development of solutions; and dissemination of guidance, tools, and educational material. The cost of this is far less than that needed for litigation and further patient care due to these incidents.

4.2 Barriers and Enablers

Fear, poor awareness and understanding, administrative issues, and the efforts required affect incident reporting [16, 37]. Simpler forms, easier access to and confidence in the reporting system, stakeholder awareness and education in incident reporting, and a non-punitive environment increase incident reporting [4].

A study of over 200 Japanese teaching hospitals noted that incident reporting by medical practitioners was more common when online reporting was possible, the time required to complete the report was short, and education about safety and incident reporting and dedicated patient-safety staff were employed [8].

Seven factors were described as either barriers or enablers to incident reporting: system access; system user-friendliness; perceived system confidentiality and security; staff training in and knowledge of incident reporting; feedback following incident reporting; workplace safety and incident reporting culture; and value or skepticism towards incident reporting [4]. Training that was perceived as good or helpful increased the rate of reporting. Security, accessibility and a local safety culture were important enablers.

Not recognizing errors, wrongly assuming near misses and minor events are too trivial to report, and mistakenly believing that certain events should not be reported, result in under-reporting. Poor understanding of the terms used in incident reporting forms or software can decrease reporting [18].

4.2.1 Fear

Fear of being blamed for an error or its adverse consequences, or perceived as incompetent by peers are reasons for not reporting incidents. Fear of being perceived as telling tales, penalized, or sued; and anonymity not being respected hinder reporting [21]. The language used in incident reporting forms and in follow-up questions must be carefully chosen to avoid suggestion of blame and to reinforce the value of reporting. Interestingly, immunity from punishment did not affect but the time required to complete the incident form did affect reports filed by Japanese nurses [8].

4.2.2 Organizational Issues

The organizational barriers include a lack of feedback and acknowledgement following incident reporting [16] and a perceived mismatch between an organization’s response and the severity of the incident outcome. Feeling that suggestions to improve safety are being ignored hinders reporting. Hierarchical rather than team-oriented cultures are associated with lower reporting rates [37]. The NPSA noted that reports by doctors are over-represented in the incidents entered directly into NRLS [18]. This suggests there are barriers to reporting locally and the extra protection offered by an independent reporting agency is important, at least until the doctors are more confident that the workplace culture is just and non-punitive.

4.2.3 Leadership

For incident reporting to become and stay as a part of the culture, i.e. ‘the way we do things around here’, it is essential to have the support and active promotion by an organization’s leadership [16]. Whilst managers and directors need to promote reporting, the active participation of opinion leaders or champions is vital.

4.2.4 Incentives

Incentives for reporting incidents can be used to encourage participation. Continuing professional development (CPD) credits are offered to radiologists in Australia and New Zealand whenever a report is filed in the RaER database. Radiology trainees are required to file incident reports as part of their training. From a broader perspective, another key motivation is a contribution to better patient safety by the sharing of information anonymously with other practitioners and thus minimizing future errors [5].

4.3 Closing the Loop

Collecting data is ineffective if it is not used to improve patient safety. Incidents need to be analyzed and classified; and solutions developed, communicated and evaluated [30].

4.3.1 Data Analysis

A classification system is needed to analyze incident data. The use of a common system helps data sharing and comparison. This should be constructed to meet the specific needs of the clinical field. For example, RaER uses a dedicated classification based on AIMS, which in turn uses the WHO’s international classification for patient safety [31].

The risk posed by an incident should be evaluated according to its severity and likelihood (Fig. 11.3). A risk matrix is a commonly used tool [35]. This maps the severity of impact against the likelihood of occurrence and can help to prioritize analysis and development of solutions.

Fig. 11.3
figure 3

Risk evaluation. The risk for an incident is evaluated by taking into account of the likelihood i.e. probability shown in rows, and the consequence i.e. severity of damage shown in columns. The risks are grouped as either extreme, high, moderate or low. Risk evaluation enables the identification of incidents with higher risk and the prioritization of corrective actions

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When analyzing incidents, three key steps need to be reviewed [34]:

  1. 1.

    The events preceding and leading up to the incident;

  2. 2.

    The problems and errors that occurred during the incident; and

  3. 3.

    The factors contributing to the incident.

By identifying the contributory factors and system issues it is possible to develop solutions to improve quality and safety. Whilst some incidents are common, others are very rare in any setting. By pooling the incident data, rare events are readily recognized rather than being regarded as ‘one off’ events. This is one way in which rare adverse drug reactions are detected.

4.3.2 Solution Development

Some solutions may be apparent from the narrative text; others may need a review by experts from other fields or an application of solutions from others. The individuals who report the incidents are often aware of the ways in which these events could have been avoided. Common themes may be detected by examining the narrative. The contribution of radiology, patient safety and human factors experts in the development of solutions for incidents in radiology and medical imaging will most likely result in solutions that will work in practice.

4.3.3 Implementation Strategies

The effective implementation of preventive and corrective actions needs clear communication of workable and practical safety solutions. Clear communication about the rationales for the patient safety strategy, education on how to use the solutions, and implementation assistance all contribute to the uptake of a new policy or procedure. Sometimes it is necessary to mandate changes by legislation. Medicolegal risk is a powerful motivator.

Following an analysis of the radiology incidents in the NRLS, the NPSA in conjunction with the Royal College of Radiologists have modified the WHO’s surgery safety checklist for use in radiology (NPSA 2012a, [20]). The key items included in this checklist are the confirmation of:

  1. 1.

    Compliance with radiation exposure regulations;

  2. 2.

    Renal function;

  3. 3.

    Bleeding risks;

  4. 4.

    Recording of implanted devices; and

  5. 5.

    Specimen labeling.

Additional requirements include team briefings and debriefings and the marking of the procedure site.

Using a number of education strategies simultaneously recognizes the fact that individuals learn in different ways. These strategies can include email, letters, visual or audio broadcasts or recordings, workshops and seminars. The contents might contain case studies, data analysis and safety improvement solutions. The NPSA issues ‘safety alert broadcasts’. Medical defence organizations send newsletters and some hold workshops and seminars. Informal communication of information conveyed through professional networks is not sufficiently robust and cannot guarantee that everyone will be informed.

4.3.4 Audit and Monitoring

The effectiveness of any new process or policy must be assessed. A suitable period of time for education and implementation is necessary before audit is performed. The results of audit and ongoing monitoring can determine how effective a strategy is in the workplace and what if anything needs to be changed to achieve the intended safety improvement.

4.3.5 Feedback

Timely feedback showing how incident reporting is improving healthcare is vital [16]. An acknowledgement of reports informs the reporters that their efforts and concerns are valued. Feedback about the effectiveness and user-friendliness of safety improvement solutions is invaluable and can often explain why the uptake has been satisfactory or less than expected.

4.3.6 Closing the Loop

Continued incident reporting closes the loop. An increase in incident reporting is associated with a timely acknowledgement of reports and the development and implementation of solutions. Ongoing incident reporting helps to identify new threats, detect recurrence of old threats and encourage the reflection on patient safety and therefore safer practice.

5 Benefits

Better use of resources, reduced costs, increased responsiveness and pre-empting complaints are cited as benefits [16]. These benefits are in addition to safer care, which also can improve staff morale.

6 Limitations

The limitations of incident reporting systems include under-reporting and reporting bias. Under-reporting is inherent in any voluntary system. By its very nature, incident reporting will not capture all events. In one review, under-reporting has been estimated to range from 50 % to 96 % [8]. Another review noted near misses are widely under-reported both in its databases and the literature and concluded that it is impossible to determine the magnitude or frequency of any problem [27].

When compared with a review of medical records, incident reporting is more likely to find near misses or incidents resulting in no or little harm than catastrophic incidents, and is unlikely to include known side effects and complications [22].

Another bias is that some incident types, such as medical device failures, are more likely to be reported to other agencies. The reporting of incidents varies between staff groups. The data collected depends on the design of the reporting system and this can reflect the background of those who set up the database. The details may not be as complete as, for example, root cause analyses [16]. Unless there are robust links between the different databases it is necessary to report related incidents more than once: this may result in under-reporting in each individual database. Incident reporting is subject to hindsight bias and lost information [32]: a reporting system needs to be designed to minimize these risks.

7 Reporting Systems

7.1 Radiology Event Register (RaER)

The Radiology Events Register [9, 24] is a radiology incident reporting system established in 2006 as part of the Royal Australian and New Zealand College of Radiologists’ (RANZCR) Quality Use of Diagnostic Imaging Program [12]. The Australian Patient Safety Foundation (APSF), an organization with a long history of incident report collection and analysis, manages this database.

The aims of the RaER are to:

  1. 1.

    Collect data on errors that occur in radiology and medical imaging;

  2. 2.

    Classify and analyze this data; thus gaining an understanding of the types of incidents, the contributing factors, the mitigating factors and outcomes; and

  3. 3.

    Disseminate this information to improve patient safety.

The model chosen was on-line, anonymous and open to anyone, professional or lay, who had experienced an incident in radiology and medical imaging.

As incident reporting is not a part of the culture in radiology, an extensive education campaign was conducted to demonstrate the system, its ease of use and value. Modifications were made, based on feedback from the users. The RaER is peer-led and driven and is not connected to any regulatory body or employer. The on-line reporting feature means that it is easy to report an incident from anywhere with internet access.

The RaER database does not replace other hospital-based or agency-based incident reporting systems. Ideally, there would be links between these databases and the relevant information need to be entered only once.

7.2 Other Reporting Systems

The first specialty-specific incident reporting databases were in anesthesia. Given the potential for catastrophic harm for an event to occur very quickly to an individual patient, this is perhaps not surprising.

The Radiation Oncology Safety Information System (ROSIS) is a voluntary international incident reporting system for radiation oncology developed under the auspices of the European Society of Therapeutic Radiology and Oncology in 2001 [23]. French practitioners are legally required to report over-exposures in radiotherapy [3]. Based on more than 7,500 incidents the WHO classified the radiotherapy processes and outlined the procedural risks and controls.

In addition to RaER, examples of other incident reporting systems for radiology are: Radiology Events and Discrepancies (READ), Safety in Radiological Procedures Program (SAFRAD) and General Radiology Improvement Database (GRID). The Royal College of Radiologists (RCR) has established an incident reporting database named READ: access is restricted to RCR members and fellows via password-protected login [33]. The International Atomic Energy Agency launched SAFRAD as a reporting system for over-exposures in fluoroscopy [10]. It informs the practitioners of the causes and the controls. The General Radiology Improvement Database is an initiative from the American College of Radiology as part of the National Radiology Data Registry (NRDR). It collects and aggregates data such as turnaround times and incident rates and uses these data to establish benchmarks and to improve practice [1].

There are several databases devoted to incidents in general practice. Most hospitals and healthcare systems have an incident reporting system. This ranges from small systems based in individual hospitals to nation-wide systems such as NRLS set up in England and Wales by the NHS in 2003. During 2009, the NRLS had recorded a total of 16,112 incidents involving radiology and 15,239 of these resulted in no or low patient harm [20].

8 Other Methods of Error Detection

There are many other ways to detect error, each with it own strengths and weaknesses. As these methods often gather different sorts of information they are complementary to incident reporting. Examples include: morbidity and mortality meeting, audit, medical record review, complaint analysis, prospective risk assessment, confidential review, observational study, organizational review, blind double reporting in radiology etc. [30].

9 Challenges and Innovations

An incident reporting culture is not widespread in medicine and radiology in particular, resulting in low reporting rates [9]. Despite strong promotion, the logging of incidents has not been an overwhelming success. The use of innovative approaches by including the requirement to log incidents during training, i.e. ‘educate the young and regulate the old’ and by awarding CPD credits for incident reporting hopefully will change the reporting culture and rate over time.

On-going improvements to the incident reporting system is essential, e.g. by making the data fields in the incident form less ambiguous, more intuitive and user-friendly, thus facilitating reporting and minimizing the time required. Any hurdles encountered during report filing will only discourage reporting in the future. Systems where relevant incidents entered into a database are automatically shared with other craft-specific databases, after removal of identifying information, would be invaluable. The technology to do this is currently available [16]. Finally, the development of a just culture based on fairness and social justice in the workplace is necessary to encourage the reporting of incidents.

10 Conclusion

There are many actions used to improve quality and to minimize error in radiology and medical imaging, e.g. by strengthening awareness, research, education, and infrastructure. Past experience has laid a strong foundation and provides guidance to future actions meeting the needs of the different stakeholders. Radiologists have a responsibility to provide quality radiology and medical imaging procedures and a duty to ensure safe and effective patient care. Leading the charge through advocacy for and participation in incident reporting and collaborating with other experts in patient safety, radiologists will ensure good medical practice and position the specialty at the forefront of quality and safety. As radiology and medical imaging play a pivotal role in the management of almost all in-patients and many outpatients, effective implementation of incident reporting will bring real benefits to the community.