International comparative analyses of incidents reporting systems for healthcare risk management

Authors


Correspondence
Youping Li, Chinese Evidence-based Medicine Center,
West China Hospital, Sichuan University,
No. 37 Guoxue Xiang,
Chengdu 610041, China
Tel: +86-28-85423040
Fax: +86-28-85422253
Email: yzmylab@hotmail.com

Abstract

Objective To compare administration of incidence reporting systems for healthcare risk management in the United Kingdom, the United States, Canada, Australia, and Taiwan, and to provide evidence and recommendations for healthcare risk management policy in China.

Methods We searched the official websites of the healthcare risk management agencies of the four countries and one district for laws, regulatory documents, research reports, reviews, and evaluation forms concerned with healthcare risk management and assessment. Descriptive comparative analysis was performed on relevant documents.

Results (1) A total of 142 documents were included in this study. The United States had the most relevant documents (68). (2) The type of incidents from reporting systems has expanded from medication errors and hospital-acquired infections to near-misses, and now includes all patient safety incidents. (3) The incidence-reporting systems can be grouped into two models: government-led and legal/regulatory/NGO-collaborative. (4) In two cases, reporting systems were established for specific incident types: One for death or serious injury events (the sentinel events database in Britain, SIRL), and one for healthcare-associated infections (NHSN in America). (5) Compared to the four countries, Taiwan's system put more emphasis on public welfare, confidentiality, and information sharing. The contents of reporting there covered every aspect of risk management to create a more secure environment.

Conclusion (1) Britain's national reporting and learning system was representative of a government-led model; (2) The United States was the earliest country to have a reporting system, which included a limited range of incident types. Management of incidents became more reliable with increased application of laws, regulations, and guidances; (3) Both the Canadian and the Australian systems drew from the American experience and are still developing; (4) The Taiwanese system was comprehensive and is an instructional case.

This is the second article in a series of comparative analyses of healthcare risk management. These articles focus on the concepts, policies and regulations, institutional management, incidence reporting systems, and tools of risk assessment and performance evaluation of healthcare risk management, as well as early warning systems, in the United Kingdom, the United States, Canada, Australia, and Taiwan. The purpose of this series is to provide evidence and policy recommendations on national healthcare risk management for health policy decision makers. In this article, we report on management mechanisms of incident reporting systems for healthcare risk management.

Methods

See article one in this series for search methods, inclusion criteria, quality assessment, data selection extraction, and analysis (1). In keeping with the aims of the study and the principles of non-classical systematic review, we mainly searched official websites. We used a simple classification system for included documents. Moreover, we chose the reporting systems which were relative perfect in state or province level for further comparison.

Results

A total of 142 documents were included in this study. The United States had the most relevant documents (68).

Overview of incident reporting systems

The United States first started monitoring medication errors in 1987. It then developed several types of reporting systems administered by the government or NGOs, with some overlap in monitoring and management. Only events that affected patients (as opposed to near misses) had to be reported. Britain has used feedback learning mechanisms to establish a unified national reporting and learning system, standardized definitions of terms, and relevant policy guidelines. The Canadian system is led by the Department of Health, which designated the professional association to manage the Canadian Medication Incident Reporting and Prevention System (CMIRPS) whose name is not rational, in fact, it included the patient safety incidents to be reported. Reporting of incidents in Australia is managed by state governments and NGOs, and includes both events that occurred and near misses. Taiwan has adopted the US model to deal with all patient safety incidents (Table 1).

Table 1.  Overview of incident reporting systems
CountryCharacteristics of incidents reporting systems
NameDate StartedVoluntary/MandatoryOrganizationAim(s)CoverageIncident type
USA (2–8)MERP1987VoluntaryISMPProvide expert analysis of the systemic causes of medication errors and disseminates recommendations for preventionNationalErrors, near-errors, or hazardous conditions
The Sentinel Event Database1995Partly mandatoryJCAHOIncrease general knowledge about sentinel events, their causes, and strategies for preventionNationalSentinel events
MEDMARX1998VoluntaryUSPTrack and identify trends in adverse drug reactions and medication errorsNationalMedication errors
NHSN2005Partly mandatoryCDCEnable healthcare facilities to collect and use data about healthcare-associated infections, adherence to clinical practices known to prevent such infections, incidence or prevalence of multidrug-resistant organisms within their organizations, trends and coverage of healthcare personnel safety and vaccination, and adverse events related to the transfusion of blood and blood productsNationalHealthcare- associated infections
UK (9–11)NRLS2003MandatoryNPSACollect, collate, and store data on patient safety incidents, and provide feedback to the NHS on how this key component of healthcare can be improved, through a range of reports, alerts, and other guidanceNHS organizationsPatient safety incidents
SIRL2010MandatoryCQC• Provide a nationally consistent definition of a serious incident that requires investigation;
• Clarify roles and responsibilities;
• Provide guidelines to ensure that all incidents are reported to relevant bodies in order to ensure full investigation of and learning events
NHS organizationsSerious patient safety incidents
Canada (12,13)CMIRPS2002VoluntaryCIHI• Coordinate the capture, analysis, and dissemination of information on medication incidents;
• Enhance the safety of the medication system for Canadians;
• Support effective use of resources through reduction of potential or actual harm caused by preventable medication incidents
NationalMedication errors
Australia (14,15)AIMS1998Partly mandatoryNPSFCollect, classify, analyze, manage, and draw lessons from things that go wrong in healthcare.NationalNear misses; sentinel events
Taiwan (16,17)TRP2003VoluntaryDepartment of HealthImprove patient safety, and create a culture of safety for medical treatment and medical institutions to share and learn from experiences.ProvincePatient safety incident

Comparison of incidents reporting systems

Table 2.  Comparison of incidents reporting systems in four countries and one district
CountryOrganizationVoluntary/MandatoryPrivacyCoverageType of incident
National/StateNGOMandatoryPartly mandatoryVoluntaryNationalProvince/StateMedication errorsHealthcare-associated infectionsSentinel eventsNear missesPatient safety incident
USA     
Australia       
Canada    
UK       
Taiwan        
Summary1. USA: Both governmental agencies and NGOs administer systems;
2. Australia: Incident reporting systems are developed by NGOs;
3. Canada: Health Canada guides, supervises, and disperses funds; NGOs designated by Health Canada undertake operational management reporting system
4. UK: Department of Health is the sole administrator
5.Taiwan: Equivalent to the management of provincial level.
1. UK: The only national mandatory reporting system;
2. USA & Australia: Some mandatory and some voluntary reporting.
3. Canada & Taiwan: Completely voluntary.
 UK: Covers only England and Wales.Medication errors were the first incidents to have a reporting system, in 1987 in the United States (MERP). Reporting then expanded to other incident types and other areas.
USA: medication errors, sentinel events, healthcare-associated infections.
Australia: near misses, sentinel events.
Canada, UK, and Taiwan: All patient safety incidents.

The National Reporting and Learning System in the United Kingdom

The reporting system is managed centrally in the United Kingdom, in keeping with the traditional governance system of the country (Table 3).

Table 3.  The National Reporting and Learning System (NRLS)
Time Stated2003
Administrative organizationNPSA
CommissionEnables the NPSA to identify patterns and themes in patient safety, and provide feedback to the NHS on how this key component of healthcare can be improved, through a range of reports, alerts, and other guidance
ReporterNHS organization, staff, doctors, patients, and relatives of patients
CoverageEngland and Wales
How to report1. Directly via an electronic form (eForm)
2. Through the local risk management system (90%)
What to report• The service type (acute, mental health, primary care) where the patient safety incident occurred
• The location of incident
• Date and time of the incident
• Contributing factors (e.g., problems with communication, education and training, or equipment and resources; patient characteristics)
• Description of what happened
• Actions planned or taken to date to prevent a recurrence
• Patient details: age range, date of birth, sex, ethnic group, disability
• Degree of harm to the patient (severity) – e.g., no harm, low, moderate, severe, death
• Actions taken to prevent the incident from affecting the patient(s)
• Effect of the incident on the patient (physical, psychological, etc.)
Grading of patient safety incidentsA. No harm:• Impact prevented – Any patient safety incident that had the potential to cause harm but was prevented, resulting in no harm to people receiving NHS-funded care.
• Impact not prevented – Any patient safety incident that was not prevented, but did not cause harm to people receiving NHS-funded care.
B. Low: Any patient safety incident that required extra observation or minor treatment and caused minimal harm to one or more persons receiving NHS-funded care.
C. Moderate: Any patient safety incident that resulted in a moderate increase in treatment and caused significant but not permanent harm to one or more persons receiving NHS-funded care.
D. Severe: Any patient safety incident that appears to have resulted in permanent harm to one or more persons receiving NHS-funded care.
E. Death: Any patient safety incident that directly resulted in the death of one or more persons receiving NHS-funded care.

Risk management of patient safety and early warning monitoring is managed entirely by the government in the United Kingdom, which established the National Patient Safety Agency and started the national reporting and learning system (NRLS). NRLS was integrated into existing local risk management systems (which account for 90% of the total reports), rather than built from scratch. At present, the system only covers England and Wales (no explanation was found about why it does not cover Scotland or Northern Ireland). A standardized reporting form was developed for different groups of reporters to facilitate data compilation and analysis. Furthermore, NRLS also developed event classification standards, allowing the agency to quickly determine the appropriate response level.

Comparison of incident reporting systems in the United States, Canada, and Australia

Table 4.  Comparison of MERP, MEDMARX, CMIRPS, and AIMS
CountryUSACanadaAustralia
Incident reporting systemMEDMARXMERPCMIRPSAIMS
Year Started1998198720021998
OrganizationUSPISMPISMP Canada CIHINPSF
DatabaseNational Internet database (commercial)National confidential voluntary reporting system (non-profit)National confidential voluntary reporting system (non-profit)Partly mandatory (commercial)
Type of incidentMedication errors All patient safety incidentsNear misses and sentinel events
AimsTrack and trend adverse drug reactions and medication errorsImprove medication safety• Coordinate the capture, analysis, and dissemination of information on medication incidents
• Enhance the safety of the medication use system for Canadians
• Support effective use of resources through reduction of potential or actual harm caused by preventable medication incidents
Collect, classify, analyze, manage, and learn from medical errors
Services• Leverage a standardized terminology and classification system that is continuously updated with the latest medication data elements;
• Easily generate compelling presentations on medication errors and adverse drug reactions for management and committee meetings;
• Analyze data comparisons between similar facilities for performance measurement;
• Find common trends across like facilities throughout a region or nation;
• Review interventions used by others to improve medication safety;
• Seamless transfer Quantros Event;
• Report manager medication and ADR events into the MEDMARX system
Provide expert analysis of the systematic causes of medication errors and disseminate recommendations for prevention• Data standards development and maintenance;
• Secure data collection, transmission protocols, processing, and data quality;
• Analysis and reporting;
• Promotion and communication services; and
• Client support services
• Client-defined incident data capture form;
• Single point of entry for multiple data sources;
• Unique HIT-Classification™ to reveal the how and why of incidents;
• Comprehensive analysis, including a range of reports;
• Sophisticated security & administrative controls;
• Workflow tool for management of corrective actions, notifications (sentinel events) and responses;
• Risk register tool for integrated risk management
What to reportMedication data• Administering the wrong drug, strength, or dose of medications; confusion over look-alike/sound-alike drugs; incorrect route of administration; calculation or preparation errors; misuse of medical equipment; and errors in prescribing, transcribing, dispensing, and monitoring of medications.
• Description of the error or preventable adverse drug reaction.
• Was this an actual medication error (which affected the patient), or a potential error that was discovered before it reached the patient?
• Patient outcome.
• Type of practice site (hospital, private office, retail pharmacy, drug company, long-term care facility, etc.).
Same as MERP, with the addition of date and time of incident; possible contributing factors; type of health service provider; contact information of reporting person.User-defined data collection form
  • The generic name (INN or official name) of all products involved.
• The brand name of all products involved.
• The dosage form, concentration or strength, etc.
• How was the error discovered/intercepted?
• Recommendations for error prevention.
  
Event classificationDefined by USPCIHI leads in collection and processing of standardized data reported by health service organizations (HSOs), including management issues related to data quality.AIMS classification
UsersHospitals and healthcare facilitiesFDA MedWatch program and the manufacturer/labelerRegistered or unregistered individual users or organizations that require information 
Reporting waysHospitals and health care systems participate in MEDMARX voluntarily and subscribe to it on an annual basise-Forme-Form; oral or written documents; tape; CD-ROM; softwareSoftware
Feedback and LearningAnnual reportExpert analysisReports (Query-based reports; descriptive reports, Ad Hoc reports, academic research reports, etc.); bulletinsAnalysis report
NotesIn an effort to focus full attention and resources on its core standards-setting activities, USP transferred the MEDMARX reporting program to Quantros in December of 2008.In keeping with its privacy practices, if a practitioner inadvertently reports identifying patient information, ISMP Canada has mechanisms in place for prompt deletion/destruction of identifiable information. ISMP Canada does not use, store, or disclose identifiable patient information. Where practitioners voluntarily submit their contact information, this information is kept only as long as is necessary for the purpose of conducting follow up investigations or to clarify information relating to a specific medication incident.Single point of entry for multiple data sources
Similarities1. All systems were managed by NGOs and mainly reported medication errors;
2. Data collection, classification, analysis, information management, feedback and learning mechanisms aimed at strengthening the drug safety and/or all aspects of patients safety.
3. Emphasize definition of terms and data standardization, event recognition, and classification concepts
Differences1. Both AIMS and MEDMARX are commercial systems with no government funding, and rely on co-sponsorship with other organizations or their own income to maintain the operation of information products, so the range of information shared is relatively limited.
2. MEDMARX is an open internet database, so its information privacy is weak
3. AIMS is a single point of entry for multiple data sources, which enables different constituents to report data, but may lead to variability in data collection. Customized reports may thus omit some important information and analysis
Advantages of CMIRPS1.Funding:• Federal government funding through Health Canada
• Federal/provincial/territorial cost sharing with provincial and territorial Ministries of Health.
• Blended approach – while the government will continue to provide some funding, a certain percentage (yet-to-be determined) of revenues will be generated from sales of products and services on a cost-recovery basis.
2. Voluntary, confidential, and non-profit.
3. Reporting: various reporting channels, unified reporting form, designed for registered users, user participating in data analysis, sharing of information.

The Sentinel Events Database in the United States vs. the Serious Incident Reporting and Learning Framework in the United Kingdom

Table 5.  Comparison of serious incident reporting systems in the United States and the United Kingdom
CountryUSAUK
Reporting SystemSentinel Event DatabaseSerious Incident Reporting and Learning Framework (SIRL)
Date Started19952010
OrganizationThe Joint CommissionThe Care Quality Commission
Coverage areaNationalOnly England and Wales
Reporting descriptionsPartly mandatoryMandatory
Type of incidentSentinel eventSerious incident
Event objectsPatientsPatients, staff, visitors, or members of the public;Health care facilities
Incident outcomeUnexpected occurrence involving death or serious physical or psychological injury• Death or serious harm
• A scenario that prevents or threatens to prevent a provider organization's ability to continue to deliver healthcare services
• Allegations of abuse
• Adverse media coverage or public concern about the organization or the wider National Health System
Aims• To improve patient care, treatment, and services and prevent sentinel events;
• To focus the attention of an organization that has experienced a sentinel event on understanding the causes that underlie the event, and on changing the organization's systems and processes to reduce the probability of future events;
• To increase general knowledge about sentinel events, their causes, and strategies for prevention;
• To maintain the confidence of the public and accredited organizations in the accreditation process.
Improving patient safety
ServicesCollects and analyzes data on sentinel events, root causes, action plans, and follow-up activities• Provides a nationally consistent definition of a serious incident that requires investigation;
• Clarifies roles and responsibilities;
• Provides information on requirements and timescales;
• Draws together legal and regulatory requirements associated with the management of serious incidents and which form the basis of this framework;
• Provides an overarching framework developed from good practices, along with signposting tools and resources that support good practices;
• Provides guidelines to ensure that all incidents are reported to relevant bodies to ensure full investigation (including independent investigations) and learning from the event
Who is subject to reporting?Health care facilitiesNational Health Service organizations
Incident categoriesNon-reviewable Sentinel Events:• Any “near miss”
• Full or expected return of limb or bodily function to the same level as prior to the adverse event by discharge or within two weeks of the initial loss of said function
• Any sentinel event that has not affected a recipient of care (patient, client, resident)
General Serious Incident:• Unexpected or avoidable death of one or more patients, staff, visitors, or members of the public;
• Serious harm to one or more patients, staff, visitors, or members of the public or outcome need for life-saving intervention, major surgical/medical intervention, where “serious harm” constitutes permanent harm, shortened life expectancy, or
• Medication errors that do not result in death or major permanent loss of function.
• Suicide other than in an around-the-clock care setting or following elopement from such a setting.
• A death or loss of function following a discharge “against medical advice .”
• Unsuccessful suicide attempts unless resulting in major permanent loss of function.
• Minor degrees of hemolysis not caused by a major blood group incompatibility and with no clinical sequelae.
• 
prolonged pain or psychological harm (this includes incidents graded under the NPSA definition of severe harm);
• A scenario that prevents or threatens to prevent a provider organization's ability to continue to deliver healthcare services, for example, actual or potential loss of personal/organizational information, damage to property, reputation or the environment, or IT failure;
• Allegations of abuse;
• Adverse media coverage or public concern about the organization or the wider NHS;
Reviewable Sentinel Events:• Any patient death, paralysis, coma, or other major permanent loss of function associated with a medication error.
• A patient commits suicide within 72 hours of being discharged from a hospital setting that provides staffed around-the-clock care.
• Any elopement (unauthorized departure) of a patient from an around-the-clock care setting resulting in a temporally related death (suicide, accidental death, or homicide) or major permanent loss of function.
• A hospital operates on the wrong side of the patient's body.
• Any intrapartum (related to the birth process) maternal death.
• Any perinatal death unrelated to a congenital condition in an infant having a birth weight greater than 2,500 grams.
“Never Events”:• Wrong site surgery;
• Retained instrument post-operation;
• Wrong route administration of chemotherapy;
• Misplaced naso-gastric or orogastric tube not detected prior to use;
• Inpatient suicide using non-collapsible rails;
• Escape from within the secure perimeter of medium or high security mental health services by patients who are transferred prisoners;
• In-hospital maternal death from post-partum hemorrhage after elective caesarean section;
• Intravenous administration of mis-selected concentrated potassium chloride.
• A patient is abducted from the hospital where he or she receives care, treatment, or services.
• Assault, homicide, or other crime resulting in patient death or major permanent loss of function.
• A patient fall that results in death or major permanent loss of function as a direct result of the injuries sustained in the fall.
• Hemolytic transfusion reaction involving major blood group incompatibilities.
• A foreign body, such as a sponge or forceps, left in a patient after surgery.
 
NotesThe Joint Commission ensures the confidentiality of the data if disputes can be resolved through the legal channels.Specific reporting processes and monitoring of serious adverse events and response classification.
Summary1.USA: A. Events are limited to those that affect patients;
 B. The Joint Commission has a clear list of reviewable events, saving processing time.
2.UK: A. Event objects include patients, staff, and visitors at public health facilities;
 B. For health facilities, negative media coverage or public opinion and allegations of abuse are included in the reporting range;
 C. Never events and updated annually

Comparison reporting and feedback systems

Table 6.  Comparison of reporting and feedback systems in four countries
Reporting and feedback systemUKCanadaAustraliaUSANotes
Eligible reportersHealthcare facilitiesSome US states require that incidents be reported by insurance companies or plaintiffs’ lawyers, perhaps because the division of medical responsibilities is different.
Individual practitioners 
Staff 
Patients or their relativesUnknown 
Spectator 
Insurance companies or plaintiff lawyers 
Reporting channelse-FormCanada provided all means of available communication and encouraged reporting.
Oral or written reports/complaints 
Existing risk management systems 
Other forms (e.g., tapes, CDs, software) 
What to reportDate1. Different countries have different reporting requirements
2. The source of information about the event and its impact was required information in some countries.
Location 
Information source 
Contributing factors (such as communication, education, training, equipment, resources, and environment) 
Description of event 
General patient information (age, gender, etc.) 
Measures to prevent recurrence 
Severity 
Preventive measures? 
Actions to reduce the impact of events 
Impact of events on the patient (physical, psychological) 
Other information (medical conditions, contact information of reporting person) 
Agencies receiving reportsPatient safety organization 
Government health departments 
Others (national practitioners database, consumer affairs, etc.) 
Learning venueMeeting or forum 
Education and training workshops 

The National Healthcare Safety Network in the United States

Table 7.  The National Healthcare Safety Network (NHSN) in the United States
NameThe National Healthcare Safety Network
Year Started2005
InstitutionCDC
Voluntary or mandatory?Partly voluntary
Included databasesNational Healthcare Safety Network, The Dialysis Surveillance Network, The National Surveillance Of Healthcare Workers
Type of eventsHealthcare-associated infections
What to reportCLABSI – Central line-associated bloodstream infection
CLIP – Central line insertion practices adherence
VAP – Ventilator-associated pneumonia
CAUTI – Catheter-associated urinary tract infection
DE – Dialysis Event
SSI – Surgical site infection
PPP – Post-procedure pneumonia
Antimicrobial use and resistance options (MDRO/CDAD) module
AimsEnable healthcare facilities to collect and use data about healthcare-associated infections, adherence to clinical practices known to prevent healthcare-associated infections, incidence or prevalence of multidrug-resistant organisms within their organizations, trends and coverage of healthcare personnel safety and vaccination, and adverse events related to transfusion of blood and blood products.
ComponentsPatient Safety, Healthcare Personnel Safety, Biovigilance, and Research and Development.

The Indiana hospital medical error reporting rule vs. the Taiwan patient safety reporting system

We compared the hospital medical error reporting rule for the US state of Indiana with Taiwan's patient safety reporting system. We chose Indiana for purposes of comparison because it was one of the best-developed state or province-level reporting systems. The contents of the entries where similar in the two systems, but Taiwan had a more detailed description of entries in the patient safety field (Table 8).

Table 8.  The Indiana hospital medical error reporting rule vs. Taiwan's patient safety reporting system
 Indiana hospital medical error reporting ruleTaiwan patient safety reporting system
Date Started20092003
Implementing organizationIndiana State Department of HealthTaiwan Department of Health 
Mandatory or voluntary?MandatoryVoluntary 
ReporterHospitalHospital or individual 
Reporting channelsInternet, software, written reportsInternet, written reports 
Institution receiving reportsState Department of HealthTaiwan Department of Health 
Type of eventsSurgical events1. Surgery performed on the wrong body part
2. Surgery performed on the wrong patient
3. Wrong surgical procedure performed on a patient
4. Retention of a foreign object in a patient after surgery or other invasive procedure
5. Intraoperative or immediately postoperative death in an ASA Class I patient
1. Surgical events: Preoperative, intraoperative, postoperative
2. Anesthesia incidents
Device events1. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the hospital
2. Patient death or serious disability associated with the use or function of a device in patient care in which the device is used or functions other than as intended
3. Patient death or serious disability associated with an intravascular air embolism that occurs while being cared for in the hospital
1. Pipeline incidents: Pipeline slippage, loss, misconnection, blockage, failure to turn on, etc.
2. Examination, clinical laboratory, or pathological events
Patient protection events1. Patient death or serious disability associated with patient elopement
2. Patient suicide or attempted suicide resulting in serious disability, while being cared for in the hospital
1. Accidental falls to the ground or another surface
2. Injurious behavior events, such as verbal conflict, physical attacks, suicide, suicide attempt, or self-injury
Care management events1. Patient death or serious disability associated with a medication error
2. Patient death or serious disability associated with a hemolytic reaction due to the administration of ABO/HLA incompatible blood or blood products
3. Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in the hospital
4. Patient death or serious disability associated with hypoglycemia that begins while the patient is being cared for in the hospital
1. Abnormal events associated with drug administration
2. Blood transfusion transfusion-related anomalies
3. Medical, treatment and care measures related to abnormal events
4. Unexpected cardiac arrest events occurring during inpatient treatment for an unrelated disease
 5. Death or serious disability (kernicterus) associated with failure to identify and treat hyperbilirubinemia in neonates
6. Stage 3 or Stage 4 pressure ulcers acquired after admission to the hospital
7. Patient death or serious disability resulting from joint movement therapy performed in the hospital
8. Artificial insemination with the wrong donor sperm egg
 
Environmental events1. Patient death or serious disability associated with an electric shock while being cared for in the hospital
2. Any incident in which a line designated for oxygen or other gas to be delivered to a patient
3. Patient death or serious disability associated with a burn incurred from any source while being cared for in the hospital
4. Patient death or serious disability associated with a fall while being cared for in the hospital
5. Patient death or serious disability associated with the use of restraints or bed rails while being cared for in the hospital
Events linked to hospital buildings, access roads, natural disasters, hazardous materials leaks, and other environmental conditions (the effects of these events are usually not limited to one person)
Criminal events1. Any instance of care ordered or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider
2. Abduction of a patient of any age
3. Sexual assault on a patient within or on the grounds of the hospital
4. Death or significant injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of the hospital
Security events. such as theft, harassment, abduction, abuse, missing patients, or homicide
Others-Abnormal events other than those described above
Reporting processEvent identification→Assessment→ReportingReceive report→Identification→ Taiwan Patient-Safety Reporting System (TRP) management process
Reporting deadlineThe report shall be submitted not later than 15 working days after the reportable event is determined to have occurred by the hospital's quality assessment and improvement program; and be submitted not later than 4 months after the potentially reportable event is brought to the program's attentionUploading data regularly on 15th each month; Database Import: Uploading by hospital IT staff regularly
Feedback and learning-The Department of Health immediate alert, the root cause analysis (RCA) for serious events, trend analysis, risk analysis, system investigation of data, recommendations

Reporting incident types

Table 9.  Comparison of reporting incident types
CategorySub-category/description (12 items)USAUKCanadaAustraliaTaiwan
Surgical eventsOperative events
Anesthesia eventsUnknownUnknownUnknown
Device events 
Patient protection eventsInfant discharged to the wrong person, fall, suicide, self-injury, etc.
Care management eventsDrug events
Blood transfusion events
Environmental eventsIncidents related to electric shock, the use of bed rails, etc.
Criminal eventsE.g., theft, harassment, abduction, abuse, missing patient, homicide
Public incidentsProblems with hospital buildings, access roads, natural disasters, hazardous materials leaks, etc. (effects are usually not limited to one person)
Public opinion eventsAdverse media coverage or public concern about the organization
Information security eventsInformation loss of agency or personal; network problems, etc.
Total sub-categories (per region) 10116810

Three of the countries included environmental and criminal in their reporting systems (Table 9). Canada and Australia did not include public events, and only Britain required reporting of public opinion incidents and information security incidents.

Discussion

The healthcare risk management and monitoring systems in the five regions can be grouped into two systems, a government-led model and a collaborative model involving both legal and regulatory systems and NGOs.

Government-led model

Britain's national reporting and learning system was the representative government-led model. The British government implemented it by integrating and making improvements to the preexisting risk management systems. NRLS was implemented with centralized management, including capital investment and management, data collection standards, and unified reporting methods. The content of reports extends to all areas of patient safety, as well as public opinion information security, and the safety of staff, visitors, residents, and medical institutions. The system includes complete classification, identification, and the response mechanisms.

Collaborative model

MERP and MEDMARX in the United States, CMIRPS in Canada, and AIMS in Australia are all examples of the collaborative model. All of these agencies are managed by non-government organizations, which developed their own standards for data collection, events classification and identification, and response. . In all three countries, reporting systems initially focused on specific types of incidents, and later expanded. Canada's CMIRPS, which started up in 2009, was based on the model of the United States Pharmacopoeia Committee MEDMARX. The United States Pharmacopoeia Commission is thus the only external source for CMIRPS.

In both the United States and Australia, the reporting systems are commercial entities with no government funding, so they mainly rely on cooperation with other organizations and service sales to maintain operations. This limits their coverage, data sharing, and research results. In contrast, Canada both provides federal and provincial government funding for reporting, and allows the NGOs to obtain income by selling information services. In addition, Canada's SMIRPS provides education, training, and support services for provincial systems in order to better enhance patient safety mechanisms.

Special-purpose reporting systems

The sentinel events database in the United States and the serious incident reporting and learning framework in the United Kingdom are incident reporting systems for death and serious injury, and employ event classification and grading.

The US National Healthcare Safety Network

NHSN is administrated by the Centers for Disease Control and consists of three databases: the National Healthcare Safety Network, the Dialysis Surveillance Network, and the National Surveillance of Healthcare Workers. It mainly collects and analyzes data about healthcare-associated infections, adherence to clinical practices known to prevent these infections, the incidence of multidrug-resistant bacteria, trends and coverage of healthcare personnel safety and vaccination, and adverse events related to transfusion of blood and blood products.

Management of incidents reporting varied from state to state in the United States, and we chose the Indiana state government mandatory reporting rule to compare with the Taiwan patient safety reporting system because of the comprehensive nature of the Indiana system. Reporting of incidents is administrated by the Indiana state government, which mandates reporting by hospitals. Types of incidents to be reported included surgical, equipment, patient protection, care management, environmental, and criminal. Similarly, Taiwan Patient-Safety Reporting System (TPR) was managed by the Taiwan Department of Health, which collects reports submitted by both hospitals and individuals. More types of incidents were monitored than in Indiana, including public accidents and security events. So TPR managed all links of potential healthcare risk and was beneficial to control all situation.

Limitations

This study was commissioned by the Institute of Hospital Administration in China's Ministry of Health to compare relevant laws and regulations, institutional settings, and operational mechanisms of healthcare management and early warning in the United States, Britain, Canada, Australia, and Taiwan. Therefore, searches did not extend to other countries and databases. Evidence grades of included documents were defined by the authors, as there are no recognized standards for grading policy evidence.

Conclusion

Britain's national reporting and learning system was the only government-led model, and was a complete system combining public welfare, learning, and interaction.

The United States had the earliest system, and the type of reporting was limited initially. But with the implementation of additional laws, regulations, and guidance, the management of incidents became more thorough, although the federal government delegates some authority to state governments and NGOs.

In devising its own system, the Canadian government drew from the experience of the United States while devising a new cooperative model for government and professional associations. But the national regulation of the medical profession was still an edition in 1867, while provinces have introduced their own laws and regulations.

The Australian system is in development stage. It is a decentralized system that draws on the experiences of other countries.

Compared to the US state of Indiana, Taiwan's system puts more emphasis on public welfare, confidentiality, and information sharing. The contents of reports covered every aspect of risk management in order to create a more secure environment.