|Year : 2013 | Volume
| Issue : 3 | Page : 143-149
Healthcare incident reporting system in several countries: Concepts, infrastructure and features
Mohammad H Yarmohammadian1, Fatemeh Rezaei2, Masoud Ferdosi1, Abbas Haghshenas3
1 Health Management and Economics Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
2 Health Services Administration, Faculty of Management and Medical Information, Isfahan University of Medical Sciences, Isfahan, Iran
3 Family Physician, Faculty of Health, University of Technology of Sydney, Sydney, Australia
|Date of Web Publication||20-Mar-2014|
Health Services Administration, Faculty of Management and Medical Information, Isfahan University of Medical Sciences, Isfahan
Source of Support: None, Conflict of Interest: None
Background: Critical Incident Reporting System (CIRs) and in a wider scope Patient Safety Reporting Systems (PSRS) are reporting systems that identify operational errors of an organization, analyze root causes of them and recognize priorities and modifiable issues for further investigation. Also, need of resources and management are reflected in organizational challenges. Vital errors and incidents in healthcare require health organizations to have reporting systems. Materials and Methods: This is a descriptive and comparative study. The scope of this study included related reporting systems of selected countries such as the United States, Australia, England, Ireland and Denmark. Data was gathered from systematic internet search, Websites of ministries of health and websites of reporting systems included: DPSD, 'CIS', 'NRLS', ISMP and AIM. Results: Comparative criteria of reporting systems were developed under 12 scopes. These include 3 Infrastructure criteria and 9 process criteria and 4criteria of process criteria which were descriptive and 5 criteria of them were evaluative. Considering infrastructure criteria, most reporting systems are designed voluntarily, reporting internally, with the aim of learning and observing confidentiality at both individual and organizational levels. In terms of process-evaluative criteria in selected reporting systems, adverse event and close calls were often reported through closed multiple choice elements reporting forms received from secondary and tertiary healthcare coverage levels with responsibility of personnel. Prospective data collection is also less applicable in selected reporting systems. In terms of process-descriptive criteria, reporting is often performed through website, regional/local department, paper and Reports are disseminated and feedback provided to the referral organizations or staffs after classifying and analyzing them through a risk assessment model (like RCA or Systemic approach). Conclusion: Social, political and cultural infrastructure, affect the purpose of a reporting system and the purpose itself determines type, confidentiality, reported events scope and contributory factors of a reporting system.
Keywords: Adverse event reporting systems, Critical incident reporting system, critical incident report, Patient safety reporting systems
|How to cite this article:|
Yarmohammadian MH, Rezaei F, Ferdosi M, Haghshenas A. Healthcare incident reporting system in several countries: Concepts, infrastructure and features. Int J Health Syst Disaster Manage 2013;1:143-9
|How to cite this URL:|
Yarmohammadian MH, Rezaei F, Ferdosi M, Haghshenas A. Healthcare incident reporting system in several countries: Concepts, infrastructure and features. Int J Health Syst Disaster Manage [serial online] 2013 [cited 2019 Sep 23];1:143-9. Available from: http://www.ijhsdm.org/text.asp?2013/1/3/143/129137
| Introduction|| |
In the past two decades, researchers have emphasized the need for a system to gather information and improve hospital systems to minimize errors in health care. To achieve this goal "Critical Incidents Survey" technique was ﬁrst used in the 1940s by Flanagan, as a technique to improve safety and performance among military pilots. Then Cooper and colleagues, in 1978, used a 'modiﬁed critical incident technique' by interviewing anesthetists and describing preventable incidents.  Critical Incident Reporting Systems (CIR's) are any structured report of untoward and preventable outcomes of event's which could lead to patient injury or harm.  In healthcare systems, we cannot just rely on CIRs, because all incident reports' deal with human lives. So, we need to apply a more extended scope of report systems, namely, Patient Safety Reporting Systems (PSRS). PSRS are systems used to identify safety hazards, prioritize where to focus resources, develop interventions to mitigate these hazards, and evaluate whether the interventions reduced harm. These systems can be used depending on the conditions of each country at national or regional or local level. 
National reporting systems provide a clearer picture of the patient safety issues that need to be prioritized across the service, develop patient safety approaches and also direct future research.  The main purpose of national reporting systems is analysis or evaluating received reports in order to change and promote the safety level of the organization. These reporting systems should provide staff with feedback on results of reported incidents and produce a visible useful response to justify resources, expanded, and to increase the motivation to continuously report incidents. , In fact, the feedback of analyzed results of a report is much more important than the report.
Almost every reporting system is a newly developed system. Although most reporting systems are experienced in data collection and confidentiality of reports, less attention is spent on analysis and dissemination of results.  Recent studies focus on prerequisite requirements for successful reporting systems and the issues discussed in the instructional draft of World Health Organization, has also emphasized on all aspects of a reporting system. Study of Doupi about reporting systems of European Union countries, Peter Pronovost and colleagues in Intensive Care units of the Johns Hopkins Hospital, Kantelhardt in Germany and Mahajan in United Kingdom all reviewed essential features of reporting systems. ,,, In this study features of a reporting system that should be determined before implementing has been discussed so that no problems will be encountered. This has been compared in different systems.
| Materials and Methods|| |
This is a descriptive-comparative study done from September 2012 through February 2013. First comparative criteria were extracted from electronic resources including ISI, Scopus, Elsevier, Google Scholar, WHO (draft guidelines for adverse event reporting) and websites of different reporting systems in selected countries. These websites included National Board of Health (NBH) in Denmark responsible for surveying Danish Patient Safety Database (DPSD), National Patient Safety Agency (NPSA) in United Kingdom responsible for surveying National Reporting and Learning System (NRLS), State Claim Agency in Ireland responsible for surveying Clinical Indemnity Scheme (CIS), Institute for Safe Medication Practices in USA (ISMP), Australian Patient Safety Foundation responsible for surveying Australian Incident Monitoring System (AIMS) and websites of Ministry of Health in selected countries. Countries introduced by WHO draft guidelines, for adverse event reporting and some European Union countries were compared with defined criteria. The reason for selecting American, Australian and England reporting systems, was their advancement and long history and experience of these countries in the field of medical record programs and departments. In addition Ireland and Denmark have national reporting systems and in this study, criterion for setting up national reporting systems has been extracted from studies that signify the necessary requirements for implementing reporting systems at national levels.
| Results|| |
Comparative criteria for reporting systems were developed in twelve thematic scopes, which included three infrastructure and nine process features. Four of nine process features were descriptive criteria and five of nine process features were evaluative criteria. Infrastructure features included types of reporting systems (voluntary or mandatory, private or governmental, internal or external report), confidentiality (at three levels, national, organizational and individual) and objectives (learning and re-designing systems and being responsive to public accountability). The process-evaluative criteria included incident types, which must be reported in every incident reporting system, individuals or organizations to report results, data collection methods, coverage level and design of reporting forms multiple-choice element or narrative box. Process-descriptive criteria include classifications of incidents, error in different groups, analysis of reports, dissemination of results how to state reports to the reporting system and distribution and feedback of analyzed results.
Results indicated that mentioned criteria were already considered in guidelines of reviewed reporting systems and compared in [Table 1], [Table 2] and [Table 3]. [Table 1] compared infrastructure features with its criteria in five reporting systems.
|Table 1: Compared reporting systems in selected countries in terms of infrastructure features|
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|Table 2: Compared reporting systems in selected countries in terms of process features|
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|Table 3: Compared reporting systems in selected countries in terms of process features|
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It can be seen from tables that CIS and AIM reporting systems have both mandatory and voluntary report. More details about this subject can be explained according to the WHO draft guidelines. WHO clarified two main determinants for this criterion, including types of organization, as reporters and events. For example, reporting could be mandatory for sentinel event or teaching hospitals but voluntary for other organizations. Also, it can be permanent for events that cause permanent damage or cause death and voluntary for other incidents.  In terms of third infrastructure criteria, only DPSD reporting system in Denmark respect national level confidentiality for patients, reporters and even organizations.  So it could be concluded that DPSD is an internal reporting system in which information would be shared just in healthcare systems but not in external regulatory and legal agencies.  Policy could be considered as a determinant of reporting systems types including, public, private or non-profit, but it is significant to notice that even private and non-profit reporting systems could be applied at national level like AIM and ISMP. , Since CIS reporting system has responsibility for managing clinical negligence claims and associated risks, it encompasses both aspects of objective criteria but it has an internal reporting system, because the scheme covers only claims alleging medical malpractice or clinical negligence and the associated risk management issues and does not cover Employer's Liability or Public Liability claims against health agencies. These are already covered under policies of insurance with commercial insurers. 
Nine process features were compared and evaluated in [Table 2] and [Table 3]. [Table 2] compares five criteria including reporters, event types, data collection, reporting form and coverage level.
The first criterion [Table 2] divides the responsibility of reporting incidents to three dimensions. For a mandatory reporting system which is under the supervision of a regulatory agency, typically the organization is responsible for reporting accidents like HIQA* reporting systems which has not been shown in the pervious study. But in a voluntary reporting system, in which the main objective is learning from experiences and contributing design error, both organization and staff could undertake the responsibility of reporting.  Reporting systems like AIM and CIS which have both voluntary and mandatory aspects, would consider mandatory aspect for organizations and voluntary for staff and specialist. According to the WHO guidelines, one of the advantages of error reporting systems is participation of patients and their families in reporting event and it should be considered at the time of designing a reporting system, but some countries (eg. Denmark) do not have this aspect of the criterion (patients as reporters).
The second criterion is incident type categorized into eight classes according to the WHO guidelines. Since reporting close calls has no harm, the reporter is not at risk of blame or litigation and it could be applied in both voluntary and mandatory (CIS) reporting systems. Although reporting systems with responsibility to external regulatory and legal agencies like DPSD, must report AEs(Adverse Event) or SEs (sentinel event). However, other types of events could be considered in the reporting system, according to their capacity and ability to analyze masses of data. ,
The third criterion indicates four methods for data collection which could be applied according to economical, technological and knowledge capacities of a country. Various combinations of these methods are possible, for example, Denmark first collects and analyzes data from departments where incidents have occurred, then if the incident is serious or widespread, the information is referred to representatives from the five Danish Regions so that they report to the national board of health (both external and internal sources). ,, Data collection method of Australian reporting system includes all methods except prospective approach since in addition to importing data of standardized reporting form into APSF software, other source of information like medical record review, medico-legal investigation, complaint review and is considered. , Like the Australian reporting system, the CIS system encompasses all methods, including analysis of malpractice claims, error reporting systems, clinical surveillance, patient care observation and medical record review except prospective approach. ,, Data collection method of England reporting system uses external and retrospective approaches which include electronic reporting forms, patient and families patient reports and local risk management system (LRMS) of after two hours. Investigation of reports submitted locally, remains the responsibility of the local organizations. ,, Institute for Safe Medication Practices (ISMP) which excludes external source of information, gathers information through interview, observation, and FMEA methodology. ,,,
The forth criterion included two aspects: Multiple-choice Element and Narrative Box (described from what had happened according to the reporter's point of view). No information is found for the DPSD reporting system. The Multiple-choice Element aspect determines inputs of a database; therefore, fewer resources are needed for analysis than the Narrative text approach. But Narrative text approach provides deeper insight into the nature of the defects. ,,
The fifth criterion indicated that the primary level of service delivery is not covered by the DPSD system.  but CIS covers "Patient Houses" as primary level of service delivery  in which GPs are also present and nursing care is also performed. AIM also cover all levels of service delivery except some of rural areas. 
[Table 3] compares four criteria, which include classification methods, analysis methods, and way of reporting, feedback and disseminations.
In terms of the sixth criterion, DPSD system classifies events into nine categories. These included events associated with medication, surgical/invasive procedures, concerned falls, suicide and attempted suicide, anesthetic procedures, mistaken patient identity or staff miscommunication, breaks in continuity, cardiac arrest or unexpected death and other types of events.  The Australian Incident Monitoring System (AIMS) classified events according to the Generic Reference Model (GRM), which utilizes the Healthcare Incident Types Classification (HIT Classification) to extract salient information about an event through a series of user-friendly, cascading, natural language questions. Items included are, explanation of information about an event (type, component, person involved, timing of the incident, timing of detection, method of detection, preventability), placing the event in its proper context, and recording system and/or human based factors, contributing to the event, factors minimizing or aggravating outcomes or consequences, and outcomes for the patient and organization. , In The United Kingdom's National Reporting and Learning System (NRLS), events are categorized into six groups including incident details (i.e. type, location, specialty area, outcome); patient details (i.e. demographic and pertinent clinical information); medication; medical devices; staff details; and contributing factors. Contributing factors include those related to the patient, the task, team or social dynamics, the environment, communication, education and training, equipment and resources, medication, and/or organizational structure.  Process-based ISMP reporting system is classified according to 10 key elements including (1) patient information, (2) drug information, (3) communication of drug orders and other drug information, (4) drug labeling, packaging, and nomenclature, (5) drug standardization, storage and distribution, (6) medication device acquisition, use, and monitoring, (7) environmental factor, work flow, and staffing pattern, (8) staff competency and education, (9) patient education, (10) quality processes and risk management. ,
According to the seventh criterion, data analysis in Denmark is done through Safety Assessment Code (SAC) system, in which each event is assigned a risk score on a scale of 1 to 3 based on its severity and probability of occurrence. Almost all analysis is done at an organizational level but Root Cause Analysis (RCA) of adverse events having a high risk score is done at five regional levels.  The England reporting system applies Human Factor Approach (HFA) with a systematic analysis viewpoint to incidents and events. In addition to considering the human factor role in occurrence of incidence, it also investigates technological and organizational issues. Pattern analysis and recognition of trends or clusters during this time will lead to recognition of important changes in a system and this is considered another type of analysis. , Like NRLS system, CIS is done through STARS web, which enables aggregated statistical analysis and supports detection of trends both at the enterprise and national level. , ISMP reporting systems use various methodology for risk analysis like Failure Mode and Effective Analysis (FMEA), Hazard Identification Model (HIM), Root Cause Analysis (RCA), Human Error Approach (HEA), and Comprehensive Proactive Risk Assessment (CPRA). ,,
Except routine reporting systems, NRLS and DPSD have developed specific mechanisms to report incidents. The Local Risk Management System (LRMS) in England collects most patient reports from hospitals and other organizations and then sends it to the NPSA. Also, an electronic web-based reporting form has been developed as an interim measure for those organizations that have not yet established an LRMS. , In Denmark, representatives from the five Danish Regions and the hospitals are involved in collecting data on patients and analyzing adverse events and making sure that the data is anonymous before being forwarded to the National Board of Health.
| Discussion|| |
In this study we have found two main category of reporting features. These categories and subdivided categories can be seen in the figure below. We have considered two main categories of reporting system including infrastructure feature and process feature. Process feature is subdivided into descriptive and evaluative criteria. Reviewed study of Doupi investigated the experiences of reporting systems in Europe (England, Scotland, Ireland and Denmark). In this study, the main characteristics of national reporting systems such as objectives, nature and confidentiality aspects were introduced. Process features such as who are the reporters, how does reporting take place, anonymity, what is reported, analysis and dissemination were introduced. Our study introduced four more process features, which included data collection, reporting form, classification and coverage level. Subcategories of both main and process features are maintained with more details in this study. 
In the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, six criteria in selected countries were reviewed. These included types of reporting systems (objectives, governmental or private or non-governmental, mandatory or voluntary), event types, reporters, techniques of reporting and analysis, dissemination and feedback of results. As you can see, WHO considered all mentioned criteria ambiguously and under a broader scope compared to our study. 
Study of Peter Pronovost and colleagues entitled as "Improving the value of patient safety reporting systems" developed an incident reporting systems for Intensive Care Unit named (ICUSRS) and then evaluated its potential benefits, challenges and limitations faced by PSRS. The challenges are explained in more detail with mentioned criteria in our study. These are, what to report, how can reporting burden and costs be minimized, how to conduct expert reviews and prioritize safety efforts, how to place incidents into taxonomies, how do we know that the reporting system actually improved patient safety, who should be responsible for attempting risk mitigation as debated in our study. In the Peter Pronovost's study, main features of a focused reporting system (ICU care) is considered. But mentioned structures for PSRS have been produced. In our study ISMP is a focus reporting system for medication and the criteria is discussed in a broader scope. 
Kantelhardt and colleagues introduced a mono-institutional anonymous critical incident reporting system in a neurosurgical department in Germany. Criteria purposed in this study included determining reporters' responsibilities (the staff of the neurosurgical department were advised to report incidents in their area of responsibility), designing reporting forms, data collection, data analysis and assessment of speciﬁc countermeasures. In addition, this focused reporting system assesses possible counterstrategies by developing the Müller formula before implementing them. Our study does not recommend a specific formula for analysis of strategies proposed in the reporting form and more details are explained for each criterion because of a focus system. 
Four main infrastructure criteria were necessitated as requirements of a successful incident reporting system by Mahajan. These criteria included data input (independent and non-punitive in reporting systems), the data (gathering information through reporting forms), analysis (the need to apply a standardized methodology and expert analysis through determining reportable events, HFA) and feedback. As it could be seen, our study considered all of the above criteria but didn't judge about the effectiveness or application of each criteria. 
As a result, it could be concluded that signiﬁcant problems remain with local and national incident reporting systems. These include fear of punitive action, poor safety culture in an organization, lack of understanding among clinicians about what should be reported, lack of awareness of how the reported incidents will be analyzed, and how will the reports ultimately lead to changes, which will improve patient safety. In particular, lack of systematic analysis of the reports and feedback directly to the clinicians are seen as major barriers to clinical engagement. Feedback directly to the clinicians is extremely important for keeping them 'in the loop' for their continued engagement, and it should target different levels of analyses. Finally, it should inform what actions, and at what level/stage, have been taken in response to the reported incidents. For this, local and national systems will be required to work in close cooperation, so that the lessons can be learnt and actions taken within an organization, and across organizations. 
| Conclusion|| |
This study determined prerequisite requirement for setting up an incident reporting system and then compared the situation in five selected countries. Each criterion was applied in various ways in selected countries depending on their political, social, cultural, economical and technological infrastructure. In open-reporting culture countries, reporters are not at risk of litigation, their identities will remain confidential, and thus incident-reporting systems are more efficient and successful. They have no authority and no power to punish the reporter or organization if it alters the outcome. Such an independent system in developed countries is applied through web-based systems for receiving and analyzing reports and disseminating results with regard to confidentiality. 
Usually learning reporting systems are voluntary systems which clarify wider scope of event types and contributing factors. These are always internal reporting systems and their reports are sent to an agency or other national body from a hospital or other health-care organization. On the other hand accountability systems are usually mandatory and restricted to a list of defined serious events. These are always external reporting systems and should be responsible to external regulatory and legal agencies [Figure 1].
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[Table 1], [Table 2], [Table 3]