Patient safety reporting systems:

A literature review of
international practice

June 2016
Contents
1. Introduction.....................................................................................................................................................3
2. Approach.........................................................................................................................................................3
3. History of PSRS............................................................................................................................................ 4
4. Challenges facing PSRS............................................................................................................................5
5. Characteristics of successful PSRS.......................................................................................................7
6. Role and characteristics of national PSRS...........................................................................................8
7. Best-practice approaches for local PSRS..........................................................................................11
8. Best-practice approaches for national PSRS....................................................................................14
9. Key questions for PSRS...........................................................................................................................17
What should be reported?........................................................................................................................17
How can we increase meaningful reporting?.....................................................................................18
How can we give patients a stronger voice in reporting and learning?.....................................18
How do we enable reporting and learning from all care settings, across the patient
journey?......................................................................................................................................................... 19
How do we close the feedback loop?...................................................................................................20
10. Emerging thinking on patient safety and management...............................................................21
Continuous improvement of patient safety.........................................................................................21
Safety strategies for the real world........................................................................................................22
Measuring and monitoring safety.......................................................................................................... 23
Transforming patient safety: a sector-wide, systems approach..................................................25
Patient safety management models and systems...........................................................................26
Renovating the NRLS and ideas for other national reporting systems.....................................27
11. Summary and key messages...............................................................................................................29
References........................................................................................................................................................30
Appendix A: Patient safety reporting systems in overseas jurisdictions.......................................33
Appendix B: Five general modes of feedback for incident reporting systems,
with examples...................................................................................................................................................39
Appendix C: Fifteen system requirements for effective safety feedback for
incident reporting.............................................................................................................................................40
Appendix D: Framework for safety action and information feedback from incident reporting 41
Appendix E: Analysis of safety along the patient journey..................................................................42

List of tables and figures

Table 1: Characteristics of successful patient safety reporting systems................................. 8
Table 2: What PSRS can achieve and what they should not do............................................. 9
Table 3: Requirements for a population-level function to recognise and respond to patient
safety risks using clinical expertise....................................................................................... 10
Table 4: Best-practice approaches for local PSRS............................................................... 12
Table 5: Best-practice approaches for national PSRS.......................................................... 14
Figure 1: A framework for safety measurement and monitoring........................................... 24

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1. Introduction
The most important knowledge in the field of patient safety is how to prevent harm to
patients during treatment and care. The fundamental role of patient safety reporting
systems is to enhance patient safety by learning from failures of the health care
system.
Sir Liam Donaldson (Chair, World Alliance for Patient Safety)[1]
Patient safety reporting in New Zealand is guided by the National Reportable Events
Policy. Under this policy, all health and disability service providers who have obligations
under the Health and Disability Services (Safety) Act 2001, and those providers who
voluntarily comply with the policy, must report patient safety incidents to the Health Quality &
Safety Commission (‘the Commission’) where significant harm or death may have occurred.
[2] The Commission publishes an annual report on adverse events that have occurred within
the health and disability sector.[3]
To inform a scheduled review of the National Reportable Events Policy, the Commission has
conducted a brief scan of overseas literature on patient safety reporting systems (PSRS).
Findings from the literature scan, along with feedback from stakeholder interviews in May
and June 2016, will help identify key issues to explore during the policy review. Findings will
also inform a wider review of the adverse event learning programme’s strategic direction.
This report summarises the findings of the literature scan.

2. Approach
The overall objective of the literature scan was to describe best and emerging practices
for PSRS, including approaches in overseas jurisdictions. This report provides the context
for findings on best-practice and overseas approaches by giving a brief history of PSRS
(Section 3), summarising key challenges facing PSRS (Section 4) and key features of
successful PSRS (Section 5), and giving an overview of the role of national PSRS (Section
6). Detailed outlines of best -practice approaches for local and national PSRS follow,
including brief commentary on approaches in overseas jurisdictions (Sections 7 and 8). In
the final sections, the report briefly re-visits some of the key questions about PSRS (Section
9), highlights emerging thinking on patient safety and its management (Section 10) and
draws together the key messages from the literature (Section 11). It is expected that findings
on best practice for local PSRS, and emerging thinking on the role of PSRS, will interest
those involved with patient safety reporting in district health boards and other health care
organisations.
Scope: The literature search included published and unpublished (‘grey’) English
language literature written since 2013.
Method: Finding relevant published literature involved searching four large databases: Ovid
MEDLINE (R), Embase, Scopus and the Cochrane Library. For unpublished literature, the
process was to use specialised Google searching and grey literature search engines (for
example, greylit.org), as well as to review the websites of relevant non-governmental,
government and think tank organisations. Search terms such as ‘incident reporting’,
‘reporting and learning system’, ‘safety reporting system’, ‘organisational learning’, ‘near

3
miss’ and ‘adverse event’ were used separately and in combination. Where articles
gained through these methods made other relevant citations, those citations were also
sourced.
Limitations: Findings are based on a limited scan of overseas literature rather than a
systematic review. It is expected that additional key themes will emerge from
stakeholder interviews and the wider policy review process.
Terms used: Patient safety terms used vary widely in the literature, in different jurisdictions
and even between different New Zealand agencies. Drawing on the World Health
Organization Draft Guidelines for Adverse Event Reporting and Learning Systems,[1] this
report uses the following definitions.
• Patient safety incident is any deviation from usual medical care that causes harm to a
patient or presents a risk of harm. This term includes adverse events and near misses.
• Adverse event is an incident relating to medical management that causes harm to a
patient. Medical management covers all aspects of care, including diagnosis and
treatment, failure to diagnose or treat, and the systems and equipment used to deliver
care. Other sources sometimes use the terms ‘sentinel event’ or ‘critical incident’ to
refer to an adverse event, but for this review we will use adverse event.
• Near miss is an incident that has the potential to cause an adverse event but fails to do
so because of chance or because someone stops it from happening. It is assumed that
the underlying systems failures for near misses are the same as for actual adverse
events.
• Never event is a patient safety incident that results in serious patient harm or death
and that could have been prevented by using organisational checks and balances.
• Patient safety reporting system (PSRS) is the processes and technology involved in
standardising, formatting, communicating, giving feedback on, analysing, learning about
and responding to reported incidents as well as in making known any lessons learned
from such incidents. Other sources sometimes use ‘incident reporting system’ or
‘reportable events system’ to refer to PSRS.
The Commission will consider terms used in its review of the National Reportable
Events Policy 2012 and adverse events learning programme.

3. History of PSRS
Health care systems originally adapted PSRS from the systems of aviation and other
industries where safety is critical. They introduced PSRS into health care because they
wished to achieve the level of resilience and response to error that high-risk industries have
achieved. In 1999 the United States Institute of Medicine’s landmark report, To Err Is
Human, recommended sweeping changes to the health care system to improve patients’
safety.[4] Drawing on the work of aviation and other high-risk industries, the report
specifically recommended adopting nationwide mandatory reporting systems that provide for
‘the collection of standardised information by governments about adverse events that result
in death or serious harm’. In 2000 the United Kingdom’s Department of Health published its
own landmark report, An Organisation with a Memory, which also recommended creating a
national system for reporting and analysing adverse health care events.[5]

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PSRS are now one of the most widespread strategies for improving safety in health care.
Recommended by international and national bodies as a key method to learn more about
risks to patient safety and how to improve it, PSRS are part of health care systems around
the world. They operate at various levels – national, regional, within health care
organisations and within specialty areas or departments – and in both public and private
organisations. Some focus on a specific type of incident or event. Although PSRS adopt
various formats, most have the same core operating model.
• Frontline workers submit reports about situations in which a patient was harmed or had
the potential to be harmed.
• Reported incidents are investigated.
• Key issues that need to be resolved and improved are identified and acted on.

4. Challenges facing PSRS

Although many countries have been quick to adopt them, PSRS around the world face many
challenges, such as the following.
• Lack of evidence that patient safety reporting actually improves patient safety: In the 15-
plus years since To Err Is Human was published, health care practitioners have submitted
millions of patient safety incident reports around the world; in the United Kingdom alone, the
National Reporting and Learning System (NRLS) receives more than 1.5 million reports each
year.[6] As yet, however, there is little evidence that incident reporting helps to deliver safer
health care.[7,8] There is also no strong evidence that PSRS perform any better than other
methods of reporting.[9] In fact, research shows PSRS detect only a small percentage of
relevant patient safety incidents.[10]
• Pressure on PSRS to provide both a learning platform and a reporting and
surveillance system: PSRS are increasingly being drawn into performance
management as incident data is used to hold organisations to account for safety
performance.[11,12] A system that tries to perform both reporting and learning roles
can create confusion and undermine its effectiveness. For example, in the United
Kingdom the NRLS cannot work as a meaningful reporting or accountability system
because reporting is voluntary with guaranteed anonymity at the national level. Yet it
also cannot fulfil its learning role because it receives such an overwhelming volume of
reports, it cannot give meaningful feedback to reporters.[13]
• Barriers to reporting: Research has identified a range of barriers to incident reporting
including time pressures, resource constraints, uncertainty about what to report, apathy
about reporting and its value, unfamiliarity with the reporting system, and fear of getting
in trouble or getting someone else in trouble.[13] A recent study found that health care
practitioners most often chose to ‘fix and forget’ safety problems, rather than ‘fix and
report’ them, when they faced problems they themselves could resolve.[14] Under-
reporting makes incident reporting less useful, not least because the reports that are
submitted provide a biased snapshot of issues within a health care organisation.[15]
• Inadequate report processing: PSRS tend to generate a large volume of highly diverse
reports that health care organisations often do not have the resources to process.
[11,15,16] Experts consider that the reasons for high volumes of reports are that PSRS:

5
− focus on reporting at the expense of investigation, learning and sharing – ‘we collect too
much and do too little’[12]
− focus on increasing reporting rates, where high levels of reporting are equated with
a stronger safety culture[11,12]
− have ambiguous and broad criteria for reportable incidents, leading to large numbers of
reports on common events (for example, falls), many of which provide little or no new
information for systems improvement[12,15,16]
− do not have effective triaging mechanisms to prioritise the reports that should
be investigated further.[15]
• Insufficient action from reporting: One of the major weaknesses of incident reporting,
which is likely to contribute to under-reporting, is that health care professionals tend not
to gain feedback or see action taken after they report an adverse event.[15] PSRS often
do not produce in-depth analyses or strong interventions to reduce risks to patient safety,
with the result that meaningful change is rare and most interventions involve education
and training. Many investigations are superficial because resources and expertise in
incident investigation are limited.[16]
• Few doctors are involved: Doctors tend not to report events, limiting the type of events
reported, which in turn limits learning opportunities for the organisation. Some reasons
why doctors are less engaged in PSRS are that they mistrust patient safety reporting
because they are afraid of how reports will be used, are uncertain about what to report,
and do not get feedback or see action resulting from reporting. Other reasons are that
PSRS tend not to produce learning relevant to local practices and there is little peer-
reviewed literature that supports incident reporting.[11,15]
• Inadequate funding and institutional support: Some patient safety experts believe
many PSRS have been under-resourced, at national, state and local levels, contributing
to the problems with processing and acting on incident reports.[11] PSRS can be under-
resourced both through inadequate financial support and through a shortage of
adequately trained and skilled analysts to deal with the volume and diversity of reports.
A related challenge that experts identify is that PSRS lack effective governance and
clear roles and responsibilities.
• Failure to capture developments in health information technology: Experts agree
that, in the future, adverse event reporting has to take full advantage of electronic
health records and related technologies.[11]

Patient safety experts and health care organisations alike are working to address the
challenges faced by PSRS and improve their effectiveness. They are exploring
questions such as: What is the role of national versus local systems? What should be
reported? How can we increase meaningful reporting? How can we give patients a
stronger voice in reporting and learning? How do we enable reporting and learning from
all care settings, across the patient journey? How do we close the feedback loop? The
following sections consider expert views on these and other questions.

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5. Characteristics of successful PSRS

A successful reporting and learning system to enhance patient safety is one in which
reporting is safe for the individuals who report, reporting leads to a constructive response,
expertise and adequate financial resources are available to allow for meaningful analysis
of reports, and the reporting system is capable of disseminating information on hazards
and recommendations for changes.[1]

In 2005 the World Health Organization Draft Guidelines for Adverse Event Reporting
and Learning Systems set out basic design and implementation principles and success
characteristics for PSRS. Although published more than a decade ago, many of the
principles and approaches remain relevant today. Key elements are outlined below.[1]
• Purpose: The fundamental role of PSRS is to enhance patient safety by learning from
failures of the health care system. Reporting – by health care practitioners within an
organisation and by the health care organisation to a broader audience through a
system-wide, regional or national reporting system – is a tool to help health care
organisations and systems learn from incidents and improve patient safety.
• Function: The most important function of PSRS is to use the results of data analysis
and investigation to make and communicate recommendations for systems change.
Reporting in itself does not improve patient safety. It is the action taken in response
to reporting that leads to change.
• Objectives: The objectives of PSRS tend to consider reporting and accountability as
well as learning. Both types of objectives can support learning and improvement.
However, the weighting applied to each one will influence system design features
such as whether reporting is mandatory or voluntary and whether reports are held in
confidence or made public. For example, a reporting system that focuses on learning
and system design usually involves voluntary reporting and spans a broad scope of
reportable incidents. A reporting system that focuses on accountability usually has
mandatory reporting of selected types of serious incidents.
• Characteristics: Table 1 lists characteristics that various patient safety experts have
identified (and that the World Health Organization has reproduced in its guidelines)
as essential to the success of PSRS.

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Table 1: Characteristics of successful patient safety reporting systems[17]

Non-punitive Reporters are free from fear of retaliation against themselves or

punishment of others as a result of reporting.
Confidential The identities of the patient, reporter and institution are never
revealed.
Independent The reporting system is independent of any authority with power to
punish the reporter or the organisation.
Expert analysis Experts who understand the clinical circumstances and are trained to
recognise underlying system causes evaluate the reports.
Timely Reports are analysed promptly and recommendations are rapidly
communicated to those who need to know, especially when serious
hazards are identified.
Systems- Recommendations focus on changes in systems, processes or
oriented products, rather than being targeted at individual performance.
Responsive The agency that receives reports is capable of communicating
recommendations widely. Participating organisations commit to
implementing recommendations whenever possible.

6. Role and characteristics of national PSRS

A national public safety reporting system is a mechanism for collating, classifying,
analysing and acting on patient safety problems at a national level.[18] International
bodies recommend states and countries establish national or regional reporting systems so
that they can gather together, at a regional or national level, reports and analyses of
incidents made at a local level.[4,5,19] Some specific benefits of analysing large collections
of patient safety incidents are that this approach makes it possible to:[20]
• identify and understand risks to patient safety that rarely occur and so are unlikely to be
characterised at a hospital or local level
• gain early warnings of the inevitable yet unforeseen new risks associated with changes
in health care practices and the introduction of new technologies
• identify common contributing factors or repeated patterns of error by drawing
together information on incidents from many different institutions.
National PSRS allow findings from local systems to be applied widely and have a national,
system-wide impact. For an overall patient safety reporting system to work, national and
local level systems need to complement each other. Systems at the local level must do the
initial reporting on the incident, handle and analyse it, and deal with immediate implications.
However, a national system can complement this work by establishing a framework to
encourage and support local reporting, by sharing lessons learned across systems and by
enabling wider surveillance of problems.[21]
Patient safety experts agree that the primary roles of national PSRS are to identify safety
issues, detect uncommon conditions and share learning (see Table 2).[11] National PSRS
cannot, and should not, monitor the incidence of harm in health care organisations or
compare organisations (see Box 1). They can, however, provide indicators of the safety

8
culture of an organisation. These recommendations are consistent with those in other
literature.[16,22,23]

Table 2: What PSRS can achieve and what they should not do[11]

Roles national PSRS can fulfil Roles national PSRS cannot fulfil
Identify safety issues Identify unsafe health professionals
Detect rare events Identify unsafe hospitals
Share safety solutions between Measure how safe one health care
organisations organisation is compared with another
Provide indicators of the safety culture of an Measure the incidence of harm in a health
organisation system
Monitor never events (through mandatory
reporting)

Box 1: Why PSRS cannot measure safety[16]

Because events are under-reported, PSRS cannot provide an accurate measure of safety.
In addition, different methods of detecting events identify different types of events so that it
is difficult to draw firm conclusions about patient safety.
• Some types of events are reported more than others (bias).
• Among reported events, some types of events have a lower threshold for reporting than
others. (For example, some report near misses; others report only those incidents that
result in patient harm.)
• Some types of events are reported often (eg, falls) while others are under-reported
(eg, medication incidents).
• Some groups of health professionals report adverse events regularly (eg, nurses)
while others report incidents infrequently (eg, physicians).
To get a valid measure of the rate of adverse events, it is necessary to:
1. use a consistent surveillance system that detects both the event and the population
at risk (as outlined above, adverse event monitoring does not gather this information
consistently)
2. clearly define the event (few adverse events in health care are well defined)
3. clearly define the population at risk (the populations in health care are usually
not defined).

The Australian Patient Safety Foundation has identified desirable attributes of national PSRS
based on lessons learned from the Australian Incident Management System.[18] In
particular, PSRS should have:
• an independent body for patient safety surveillance that coordinates the system
• agreed frameworks for: patient safety, reporting systems and a surveillance system
• agreed standards for reporting
• a single, clinically useful classification system for events that go wrong
• a national repository for data from all available sources about these events

9
• data collected across the whole spectrum of health care
• mechanisms for setting priorities at local, national and international levels
• a just system, accommodating the needs and rights of: patients and their relatives,
friends and carers, health professionals, health facilities and society at large
• separate processes for accountability and ‘systems learnings’
• explicit criteria for deciding whether the process should be open for accountability
or provide protection and qualified privilege
• a blame-free culture for reporting
• the right to anonymity for reporters
• qualified legal privilege for quality and safety improvement (‘systems learnings’)
information
• ownership of ‘systems learnings’ information by those who provide it
• systems for rapid feedback and evidence of action
• mechanisms for involving and informing all stakeholders
• mechanisms for sharing successful strategies internationally.
Authors with experience in managing large-scale PSRS in Australia, the United Kingdom and
North America have identified the requirements for a population-level function to recognise
and respond to patient safety risks using clinical expertise. As Table 3 shows, this framework
sets requirements for the system, personnel and a multi-staged risk surveillance, review and
response process. Like the Australian Patient Safety Foundation, the authors highlight the
need for mechanisms to prioritise which local reports get reviewed at a national level and
which trigger a national response. They also emphasise the importance of having a
multidisciplinary team to manage the risk surveillance, review and response process.[20]

Table 3: Requirements for a population-level function to recognise and respond to

patient safety risks using clinical expertise[20]
System 1. A means for reporting incidents that is available to all health care
requirements workers and is adequately resourced, non-punitive, independent
and confidential.
2. Software to collect incidents and other information from multiple
sources and institutions. This may directly collect information in one
database (eg, Danish Patient Safety Database) or upload it from
independent systems into a central repository (eg, NRLS).
3. A system for producing and managing reports for each stage of the
risk surveillance, review and response process (see below).
4. A system to communicate corrective strategies to health care
organisations.

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Personnel A multidisciplinary team of clinicians, subject experts and human
requirements factors experts should advise and manage the risk surveillance, review
and response process.
• Clinicians’ understanding of typical workflows and the operations of
health care organisations helps them to interpret incidents.
• Subject experts help in understanding the patterns of contributing
and contextual factors.
• Human factors personnel can advise on common error mechanisms
and how to develop corrective strategies that are strong and
sustainable.
Risk surveillance, 1. Undertake surveillance – categorical or free-text algorithms can
review and extract those incidents more likely to require a national response.
response Prioritise those incidents associated with serious harm.
process
2. Identify a ‘trigger’ incident – to identify new or under-recognised
patient safety risks requiring a national response, criteria are risks:
that are ‘novel’, not well known, involve new technologies or
processes or are part of a pattern or trend of similar but previously
unrecognised incidents; and for which there is evidence of actual
or potential significant patient harm; and for which preventive and
corrective actions are feasible, are not already widespread and
may be implemented in a cost-effective manner.
3. Collect like incidents.
4. Characterise the relevant incident type – using a framework such
as the International Classification for Patient Safety.
5. Identify preventive and corrective strategies.
6. Develop materials for a response (eg, an alert).
7. Pilot test and refine.
8. Share information about alerts and corrective strategies.
9. Evaluate.

7. Best-practice approaches for local PSRS

Table 4 summarises best-practice approaches for local PSRS. Key sources include the 2005
World Health Organization guidelines, a 2016 Delphi consensus study with patient safety
experts on the role of PSRS and a 2014 report by the Reporting and Learning Subgroup of
the European Commission Patient Safety and Quality of Care working group.[1,11,22] For
further information on what to report, ways to increase reporting and closing the feedback
loop, see Section 9.

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Table 4: Best-practice approaches for local PSRS

Recommended approach
Reporting • Just or no-blame cultural environment [1,22] – top management of
environment health care systems and organisations should spread the message
of a ‘blame-free and non-punitive’ objective. [23]
• Strong leadership and accountability [22,23] – health care
organisations should have an executive board member responsible
for patient safety and should be accountable for investigating their
own reports.[11]
• Health care organisations should share an understanding of what a
patient safety incident is and the purpose of incident
reporting.[22,23]
Reportable • The system should define incidents broadly, allowing reporting of a
incidents wide range of safety information and events.[1,11,22]
- Reporting systems may be open-ended and aim to capture incidents
along the entire spectrum of care delivery, or they may focus on
particular events or pre-defined serious incidents.
- A simple list is easier to understand and helps personnel to focus on
certain issues; however, if the criteria for what incidents to report are
too limited, useful lessons may be missed.
- With a broad definition, personnel may report any concerns,
including near misses, providing a rich resource for learning and
systems improvement; however, many events that offer no new
learning also get reported.
• Report near misses and never events.[11]
• Health care organisations should not determine their own reporting
priorities; a central system should set these.[11]
Requirement to • Make reporting voluntary, except in certain circumstances – see
report below.[1,19]
• A voluntary system should gather information on near misses and
medication incidents.[11]
• A mandatory system should gather information on never events or
serious events such as wrong site surgery, device failures and
hospital-acquired infections.[11]
• Regulations on sanctions-free reporting and clear rules of
confidentiality should accompany mandatory systems.[22]
People who Reporters should include:
report • all health care organisation staff[22,23]
• patients, relatives and other informal caregivers.[1,19]
Mode of Reporting should:
reporting • be confidential[1,19,22,23]
• allow for the opportunity to report anonymously.[1,19,22]
Incident • Use a common classification system that makes it easier to compare
classification data across care providers.[1,11,22, 23]

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Report form • Standardised reporting forms, including free-text and structured
response fields, are recommended because:[1,22,23]
- highly structured reporting helps with data analysis
- free-text or narrative reporting can capture context and story,
allowing the conditions that contributed to the error to be
explored and understood.
• The minimum data set should cover:
- basic profile of patient (age, gender, ethnicity – anonymised),
time, date and location of incident (care setting, specialty),
identity of provider organisation (Some authors suggest that, to
increase reporting, reporters should be required to provide only
this information; a patient safety specialist can provide the
rest[16])
- incident type and patient outcome (using classification scheme),
description of what happened, action taken, root cause of event
and preventative measures taken.
• Reporters should have quick and ready access to report
forms.[16,22,23]
Use simple systems so that staff can use them with little or no
training.[16]
• Use electronic/web-based reporting to promote data accuracy, make
it easier to transmit information and simplify analysis.[22]
• Use different reporting forms for health care professionals and for
patients and relatives.[22]
Incident • Analyse incidents at the level of the health care organisation.[11]
analysis • Generate solutions locally and communicate them nationally.[11]
• Experts who have insight into the subject and are trained to
recognise underlying system causes should analyse the
incident.[1,22]
• Staff should be encouraged to propose solutions for incidents at the
time of reporting.[11]
• Analysis of all incident types is desirable; however, near misses are
of a lower priority for investigation; prioritise never events and
incidents leading to death and severe harm for investigation.[11]
• Common findings of an incident analysis describe the problem, draw
conclusions and set out an action plan.[22]
Feedback • The receiving health care organisation should give timely, individual
feedback to the person reporting; it should acknowledge to the
reporter that it has received their report and keep them informed of
next steps and actions taken.[11,22,23]
Learning • Managers should share reports with staff.[16]
• Share lessons at local, regional, national and international
levels.[16]
Other data • PSRS do not provide a complete picture of risks, hazards and
sources system vulnerabilities; find support for patient safety reporting data
from other sources of information on patient safety incidents (eg,
complaints, administrative data, laboratory data, pharmacy data,
staff surveys, patient surveys).[22]

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8. Best-practice approaches for national PSRS
As Section 6 has explained, a national public safety reporting system is a system for
collating, classifying, analysing and acting on local incidents at a national level. The World
Health Organization guidelines suggest looking at national PSRS as an extension of local
systems.[1] To this end, national reporting systems have many of the same characteristics
and requirements as local systems (for example, non-punitive, independent, preferring
voluntary reporting, using clinical expertise in analysis). Table 5 highlights recommended
approaches for national PSRS that are distinct from those recommended for local systems.
For more information on prioritising reporting and analysis at a national level, see Section 9.

Table 5: Best-practice approaches for national PSRS

Recommended approach
Reportable • Prioritise which incidents to report to the national PSRS.[11,16]
incidents • Report and analyse both locally and nationally incidents with the
potential to be solved nationally, such as never events, device
failures, hospital-acquired infections and medication incidents.[11]
Report form • To support learning, collect detailed data/reports for each individual
incident (following the recommendations for the minimum data set
for local PSRS) rather than summary tables for each health care
organisation.[22]
Report review • Have a process that anonymises all incoming reports and removes
all personally identifiable information.[22]
• Have a process to ensure the quality of data in incoming reports,
including correct classification.[22]
• Prioritise incoming reports for review using algorithms to extract
incidents more likely to need a national response – prioritise
incidents associated with serious harm.[20,22]
• Review process should: [22]
-at a minimum, identify hazards in the health care system and
prioritise them for further evaluation
-be expert – evaluated by experts who understand the clinical
circumstances under which incidents occur and who are trained
to recognise underlying systems causes
-be credible – involving both independence and content experts
-be timely – reviewing reports without delay and sharing
recommendations promptly; when serious hazards are identified,
give notification of it rapidly
-result in preventive recommendations.

14
Data transfer • Provide for automatic, online dataflow between local and national
from local to systems using a Cloud platform or by integrating local systems with
national PSRS the national system.[22]
• Avoid batched transfer of data to keep up speed of data processing
and to minimise delays between local reporting and central
review.[22]
• Ensure data security (availability, integrity, access restriction) when
transporting, storing, sharing and archiving data.[22]
• Store basic data from all different sources of reports – or allow for it
to be viewed as a unified structure – in a way that allows for
integrated analysis [22]
Care settings • Cover all care settings (hospitals, laboratory settings, imaging
services, rehabilitation institutions, outpatient clinics, primary care,
pharmacies, substance abuse treatment centres, ambulance
services, home care agencies, providers of health care in social
services).[22]
• Involve both public and private organisations.[22]
Other data • PSRS do not provide a complete picture of risks, hazards and
sources system vulnerabilities. Use other sources of information to support
incident report data, for example, incidents detected from
administrative data, complaints, health and safety incidents,
inquests, claims, clinical audits, routine data, observations and
informal conversations with patients, families and staff. Introduce
mechanisms at national level to collect this information and share
the lessons learned.[1,22]
• Link automatically with pharmacovigilance and other similar systems
to avoid duplication of reporting.[22]
Sharing lessons • Methods of learning from reports include: alerts about new hazards,
learned sharing lessons learned from incident investigation; analysing
multiple reports to find trends and hazards; analysing multiple
reports to gain insights into underlying system failures and develop
best-practice recommendations.[1]
• Share preventive measures through existing channels where
possible.[22]
• Include changes in relevant, existing policies instead of merely
issuing new standalone safety alerts.[22]
• Consider providing central support for implementing change and,
where appropriate, resource that support.[22]

Patient safety reporting in overseas jurisdictions: Appendix A provides an overview of

some of the key features of PSRS in England and Wales (NRLS, the National Reporting and
Learning System), Scotland (no national PSRS but a National Framework to guide local
National Health Service (NHS) boards in managing adverse events), Denmark (DPSD,
Danish Patient Safety Database) and British Columbia, Canada (BC PSLS, British Columbia
Patient Safety and Learning System). Below is a summary of key information about these
PSRS.

15
• Reportable incidents: The NRLS, Scottish National Framework and BC PSLS include
near misses. The DPSD focuses on specified adverse events only. The NRLS
includes never events.
• Requirement to report: Most reporting is voluntary, apart from mandatory reporting of
specified serious incidents.
• People who report: The NRLS, DPSD and BC PSLS all enable patient reporting. The
reporting form they give to patients is different from the one for health care organisations
and practitioners. The Scottish system does not have patient reporting.
• Mode of reporting: The NRLS, DPSD and BC PSLS all ensure confidential reporting
and enable (if not actively encourage) anonymous reporting. Only a small proportion
of Scottish NHS boards enable anonymous reporting.
• Incident classification: Classification approaches tend to be based on the World Health
Organization International Classification for Patient Safety, or at least align with it.
Different jurisdictions use slightly different categories of severity.
• Report form: All reporting from local to national PSRS is electronic. Reporting to the
NRLS, DPSD and BC PSLS is direct to a centralised database. Scotland has no
mechanism for national reporting.
• Incident analysis: The systems analyse incidents at the local level. In addition, the
NRLS and DPSD review more serious incidents at a national level.
• Care settings: The DPSD and PSLS receive reports from across the care spectrum,
including private health care providers. The NRLS includes reporting from a wide range of
NHS-funded organisations but not private providers. The Scottish national approach has so
far focused on acute settings but is moving to include other care settings as well.
• Information sharing: The different systems use a wide range of mechanisms for
sharing information and knowledge. Of particular note, the BC PSLS in Canada uses a
publicly accessible online blog and the Scottish National Framework uses a Community
of Practice website.
• Future developments: Key developments underway in the United Kingdom include
conducting a significant project to re-develop the national patient safety management
system and establishing the Healthcare Safety Investigation Branch to support incident
analysis. Denmark is renovating its Knowledge Platform. Both Canada and Scotland are
aiming to establish national PSRS.

16
9. Key questions for PSRS
This section specifically addresses the questions raised in Section 4, drawing together the
best-practice approaches outlined in Tables 4 and 5 above with additional commentary and
expert opinion.

What should be reported?

Use broad definitions of reportable incidents at the local level, to allow reporting of a
wide range of safety information and incidents and generate a rich resource for learning
and systems improvement.[22] Include near misses and never events – see below.[11]
Set priorities to determine which incidents get reported to national PSRS from local
systems. National bodies can limit the volume of national reports by specifying incidents of
national interest, rather than receiving all reports. They may then be able to focus on current
safety priorities and be selective about which incidents they use national resources to
investigate. Events such as patient falls may not need to be collected at a national level as
they are well understood and their prevention well evidenced.[12] Some suggested
approaches to prioritise reporting are to:
• focus on a finite set of events likely to be of greatest benefit to learning and systems
improvement, which may be based on level of harm, frequency, preventability or
regional/national priority[16]
• report incidents with the potential to be solved nationally such as never events, device
failures, hospital-acquired infections and medication incidents.[11]
Near misses: Indistinguishable from adverse events in all but outcomes, near misses are
opportunities for quality improvement. The Measurement and Monitoring of Safety states
that ‘the focus is moving from counting harms after the event towards looking at hazards
that might give rise to error, or safety failure before harm has occurred’.[24] Experts strongly
agree that incidents reported to local PSRS should include near misses.[11,22] There is less
consensus about whether or which near misses should be reported at a national level.
Evidence indicates that near misses are under-reported and poorly understood in health
care settings. One study found that health care practitioners tend to ‘fix and forget’ (rather
than ‘fix and report’) when they encounter near misses. It also identified a view among
health care practitioners that reporting near misses would create overburdening paperwork.
[14] One suggestion for addressing under-reporting is to make it mandatory to report higher-
risk near misses – those that could have resulted in death or disability.[25]
Never events: Reporting never events can raise the profile of patient safety and strengthen
the focus on reducing and eliminating those events that can be prevented outright through
strong clinical and organisational systems. An organisational culture that minimises or
eliminates never events is also likely to reduce other preventable harms.[26] Experts
consulted in the Delphi consensus study on the role of national PSRS agreed that reporting
of never events should be mandatory, at both local and national levels.[11] Several
jurisdictions, including Canada[26] and the United Kingdom,[27] have developed lists of
never events.
The United Kingdom requires never events to be reported to the NRLS.[27] The NHS policy
on never events states that this type of event has the potential to highlight weaknesses in

17
how an organisation manages fundamental safety processes. Reporting never events
therefore provides the NHS with an essential lever for improving patient safety. The United
Kingdom defines never events as a type of serious incident that meet the following criteria:
• they are wholly preventable
• they have the potential to cause serious patient harm or death
• there is evidence that the category of never event has occurred in the past
• occurrence of the never event is easily recognised and clearly defined.

How can we increase meaningful reporting?

Authors of recent studies have made some clear recommendations for how to improve
meaningful reporting to PSRS (outlined below) . For further important insights relevant to
this question, see Section 10 on emerging thinking for patient safety and safety
measurement, and the question below on ‘closing the feedback loop’.
Make reporting easier: Health care providers should have quick and ready access to PSRS
(electronic, web-based). Systems should be so simple that staff can use them with little or no
training. Systems should ask for a minimal amount of information. Instead of asking the
reporting health care practitioner to categorise the event, rate the event and identify causes,
the report form might just need to ask for a free-text description and some identifying
information; a patient safety expert familiar with incident reporting can further investigate
events that have merit.[16]
Give feedback and take action. A lack of feedback and visible action as a consequence of
reporting is one of the major weaknesses of incident reporting. Give timely feedback to the
person who reports an event – this is a way of checking understanding of the report and
communicates that somebody is listening and cares about the event. Managers should
share reports with staff. In this way, they educate the staff about risks in their environment,
gain their ideas on how to further reduce risk and inform them that action occurs in response
to such staff reports. Share lessons at local, regional, national and international levels.
Leaders should devote institutional resources to not just collecting data but also analysing
events and mediating risk. When staff observe that the institution is willing to change based
on their feedback, the safety culture really starts to change.[16]
Improve physicians’ engagement: Support physicians to feel truly safe when reporting.
Establish strong medical leadership of PSRS that values medical reporting and results-
based reporting of adverse events. Demonstrate that reporting has led to tangible action
locally. Link electronic health records to electronically submitted incident reports so that
reporters can track the progress of their incident report. Clarify roles and responsibilities
for incident analysis and ownership of related actions.[15]

How can we give patients a stronger voice in reporting

and learning?
There is broad agreement that patients, relatives and, to a lesser extent, the public should
be able to report to PSRS. Many jurisdictions, including those this review covers (Appendix
A), allow patients to report.[28]

18
Patients and relatives are a potentially rich resource for learning and improving patient
safety. Patients can provide timely and important information about the safety of care
that complements information recorded in staff reporting systems.[29]
• Patients can report safety incidents that would otherwise go undetected.[30]
• Patients may be in a better position than their caregivers to identify failures in
handovers and gaps between providers across the continuum of care.[1]
• A patient may experience an injury that is not obvious until after they are discharged
from a hospital and therefore no one other than the patient or relative could report it.[1]
• Patients are highly motivated to report errors or problems in their care.[31] They are
often experts in their disease and health condition and eager to participate in developing
interventions to prevent clinical incidents.[32]
Few researchers have studied patient reporting of incidents. More research is needed on
patient self-reporting systems, and on how well-used, usable and useful they are.[32] Areas
of specific interest include: How can PSRS make patient and family reporting easier? What
are the specific requirements of the system? What mechanisms are needed to capture the
qualitative information patients provide? Do either systems or culture need to change? What
extra resources are needed?[22]
Interventions to encourage and enable patients to become involved need to be developed
and evaluated. Studies have indicated one barrier to patients using PSRS is that they often
prefer to report incidents to a researcher rather than to a national or local reporting system.
[30,33] In Denmark, when patient safety reporting is introduced, uptake is slow at first but
increases over time as awareness of the opportunity grows.[22] This slow start may be in
part because PSRS usually see patient reporting as an extension to health care providers’
reporting, and add it to the reporting system in the later stages of development. The design
therefore may not be optimal to encourage and enable patients and families to report. One
solution may be for patients to design, manage and administer surveys, creating a tool that
patients are more confident about using to report incidents.[31]
Where patients can report incidents as part of a wider PSRS, they should be made aware of
this possibility in the same way as they are made aware that they can complain or receive
compensation. They should also be made aware that incident reporting is separate from
formal complaint and litigation procedures. Reporting should use a similar structure and
classification as reporting for health care providers, making it easier to conduct a structured
analysis of the data. However, the design of the report form should also keep in mind the
needs of people who are not trained health professionals.[22]

How do we enable reporting and learning from all care

settings, across the patient journey?
There is strong agreement that PSRS should cover all care settings and should enable
reporting for both public and private health care organisations. Of the jurisdictions reviewed
for this report, three (NRLS, DPSD and BC PSLS) have reporting from across the care
spectrum. However, only the DPSD and BC PSLS include private health care providers.
Many PSRS are set up around acute care, which involves a range of different people. It can be
difficult to apply this system to other care settings, such as primary care or specialised
outpatient care, where providers are fragmented (for example, a single doctor with a single

19
nurse) and not part of a bigger organisation. Further, care settings may differ in their
reporting methods. One recommendation is to develop PSRS based on generic best -
practice and to add the specifics of care settings in later phases of development.[22] In the
United Kingdom, where the NRLS accepts reports from primary care settings, only 1 percent
of reports come from primary care. This lack of reporting reduces patient safety across care
settings as secondary care staff have little information about incidents patients have
experienced in their earlier interactions with the health service, which in turn limits
understanding of where and to what extent patients experience incidents across the sector.
[35] The United Kingdom is looking at how to enhance and support reporting from non-acute
care settings, particularly primary care.
Some patient safety experts believe that, because primary care has specific complexities,
and because physicians are important reporters of incidents in primary care (unlike in
hospital settings), primary care needs a sector-specific PSRS. An expert group with
extensive experience of working with European reporting systems has developed
recommendations on the content and structure of such a system.[34]
Evidence shows PSRS can work in primary care settings. One study of a web-based primary
care reporting system found that near misses occur frequently in office practice, mainly
involve administrative and communication problems and occasionally present a significant
risk of patient harm.[34]

How do we close the feedback loop?

Lack of feedback is a key barrier to incident reporting. ‘Closing the safety feedback loop’
means using information from reported incidents to improve the safety of frontline
clinical work systems.
If feedback is to contribute meaningfully to the overall improvement project, it cannot just
involve passively giving out the information. It is better understood as an active process of
communication that sustains a continuous cycle of learning, reporting and learning.
Feedback also plays a role in establishing accountability, as staff are more likely to report
when they are certain that someone will review and act on their report.[35] Box 2 identifies
essential elements of effective feedback.
The Safety Action and Information
Feedback from Incident Reporting Box 2: Effective feedback in
(SAIFIR) model sets out requirements for incident reporting systems[35]
feedback in a patient safety incident 1. Includes visible sponsorship from
reporting and learning system.[36] The local leadership.
model has been developed from a 2. Preserves anonymity without
scoping review of research and expert compromising learning.
advice from world leaders in safety in 3. Rewards reporters and
high-risk industries. reinforces reporting.
The SAIFIR model includes five distinct 4. Supports prioritisation of resources
modes of action and information feedback for improvement.
and 15 system requirements for safety 5. Involves and engages frontline staff
feedback processes at the organisational in the safety improvement process.
level (see Appendices B and C). An 6. Is specific and relevant to its audience.
overall Framework for Safety Action and
7. Occurs at multiple points in the
alerting and response process.
20
8. Facilitates dialogue between relevant
stakeholders.
Information Feedback from Incident Reporting draws together the feedback modes
and system requirements (see Appendix D).
Key messages from the review are that:

• effective safety feedback is not just about publicising incident rates but rather
involves timely, visible and repeatable corrective action and quality improvement
processes
• it is important to use multiple ways of feeding back actions and safety information to
promote safety awareness, improve clinical processes and maintain reporting
• risk management systems in health care organisations would benefit from a
comprehensive, common framework that has multiple modes of feedback (such as the
SAIFIR Framework).
A United Kingdom study of incident reporting in National Health Service trusts found that no
trusts used all of the best-practice requirements outlined in the SAIFIR model or used all the
five modes of feedback.[37] The authors recommended:
• building feedback into the regular reporting of patient safety issues at all levels, crucially
to the board and externally, and evaluating that feedback
• providing feedback to reporters that covers all types in the SAIFIR model, using
available information technology, paper and face-to-face methods of communication
• making the content and format of feedback part of working systems, not a bolt-on, and
having users evaluate it regularly
• providing feedback involving both information and action in all SAIFIR feedback modes,
with much greater emphasis on modifying working practices, monitoring impact, and
publicising the success of individuals and the organisation in improving patient safety.

10. Emerging thinking on patient safety and

management
This section briefly describes emerging perspectives on patient safety and how to manage
it. It does not comprehensively summarise these perspectives nor analyse their implications
for patient safety reporting. Instead, these perspectives are included to highlight different
ways of thinking about patient safety that will offer both opportunity and challenge for patient
safety reporting in the future.

Continuous improvement of patient safety

The Health Foundation’s recent report, Continuous Improvement of Patient Safety, makes the
case for changing the way the National Health Service approaches patient safety. It argues that
change is needed in: how safety is understood, because current approaches to measurement
don’t provide the full picture; how safety is improved, because existing approaches alone will
not address the most intractable problems; and how risk is perceived, because comfort-seeking
behaviours will not create a genuine culture of learning.[38]

21
The report paints a picture of what safer care might look like in the future:
A safer care system is conceived from the perspective of the patient, following his or
her journey through different care settings, irrespective of organisational
boundaries. It is networked, so that successes and failures identified in one part of
the system can be readily accessed, understood and built on in another. And it is
judged not by the prevalence of adverse events, but by the ability to proactively
identify hazards and risks before they harm patients.

Safety strategies for the real world

In recent books, Safer Healthcare: Strategies for the real world and The Measurement
and Monitoring of Safety, Charles Vincent and his colleagues pick up many of the themes
highlighted by The Health Foundation.
In Safer Healthcare, Vincent and Amalberti argue that current patient strategies need to be
complemented by strategies aimed at managing risk in ‘the real world’.[39] They suggest
that most current safety initiatives are ‘optimising strategies’ – either attempts to improve the
reliability of clinical processes or wider system improvement initiatives. In contrast, we have
few safety strategies aimed at managing risk in the often complex and adverse daily working
conditions of health care. Developing considered approaches to managing risk in such
situations is a priority for the next phase of patient safety.
Vincent and Amalberti outline key five transitions that they believe are needed to move from
the current vision of patient safety to the broader vision we need for the future (see Box 3).
Considering what these new directions mean for incident analysis, Vincent and Amalberti
point to an urgent need to return to the original purpose of incident analysis,
comprehensively investigate a much smaller number of events and consider the findings in
the context of an overall safety and quality improvement programme. In their opinion, we can
largely achieve this approach with the methods we already have. However, we also need to
think about how we include events seen as harmful from a patient perspective (for example,
poor communication) and how we reflect the importance of improving care over time.
To this end, Vincent and Amalberti propose a new approach to incident analysis (ALARME).
This approach extends the current ALARM framework/London Protocol to consider
contributing factors along the whole patient journey and pays attention to successes,
failures, recovery and mitigation. It involves patients, family, and hospital and community
practitioners (see Appendix E).

22
The authors also suggest that patients and families should select a proportion of incidents
for analysis and be encouraged to contribute as much as they can to analyses. The patient
perspective will help us to understand the longer-term safety problems and to develop new
techniques and innovations.

Box 3: Transitions to a broader vision of patient safety[39]

1. See safety through the patient’s eyes: Our current approach to patient safety
assumes the quality of health care is generally high but occasional safety incidents
and adverse events occur; this is a vision of safety from the perspective of health care
professionals. In seeing safety through the patient’s eyes, we would focus on overall
coordination of care rather than isolated errors and incidents, and on the role of
patients and families in monitoring and maintaining safety.
2. Consider benefit and harm along the patient journey: If we see safety through the
patient’s eyes, we must also see safety in the context of the patient journey. This
means we need to examine episodes of care and consider both benefit and harm over
an extended time.
3. Achieve patient safety by managing risk over time: Achieving patient safety
involves minimising incidents but also managing risk over longer periods, which will
require additional skills and methods. We accept in this vision that errors are inevitable
but that, in a safe system, very few of those errors will have any consequences for the
patient.
4. Adapt a range of safety models: Different health settings need to approach safety
in very different ways. Because health care covers many different types of activity and
clinical settings, we cannot use one primary model.
5. Develop a wider range of safety strategies: We should extend our safety strategies
to include risk control, monitoring and adaptation, and mitigation.

Measuring and monitoring safety

A lack of reliable information on safety and quality of care may be holding back
improvements in patient safety. Some authors believe that a move from unsystematic
methods, such as voluntary reporting, towards systematic measures is needed.[40] In The
Measurement and Monitoring of Safety, Vincent and colleagues propose a framework for
measuring and monitoring safety that brings together several conceptual and technical
aspects of safety.[24] The framework highlights the key dimensions that the authors believe
any safety and monitoring approach should include to give a comprehensive and well -
rounded picture of an organisation’s safety. These dimensions respond to five critical
questions about an organisation’s safety.
1. Has patient care been safe in the past?
2. Are our clinical systems and processes reliable?
3. Is care safe today?
4. Will care be safe in the future?
5. Are we responding and improving?

23
The five dimensions themselves are as follows (see also Figure 1).
1. Past harm covers both psychological and physical measures. Incident reporting is one
approach to measuring past harm. The authors note the need for more specific and
nuanced measures of harm that can be tracked over time and can demonstrate
whether health care is becoming safer.
2. Reliability, or ‘failure-free operation over time’, applies to measures of behaviour,
processes and systems. For health care to be truly reliable, the authors suggest
organisations need to look towards the ambitious goal of identifying and monitoring
all processes that are critical to safety.
3. Sensitivity to operations is the information and capacity to monitor safety on an
hourly or daily basis.
4. Anticipation and preparedness mean the ability to anticipate, and be prepared for,
problems. As these concepts are relatively undeveloped in health care, both
research and practice need to explore them further.
5. Integration and learning mean the ability to respond to, and improve from, safety
information. Health care organisations take many different approaches to integrating and
learning from the various sources of safety information. Whatever the approach,
feedback, action and improvement are key elements in integration and learning. Health
care organisations must balance collecting and integrating safety information with
appraising how to use it to deliver meaningful feedback, action and improvement (see
‘How do we close the feedback loop?’ in Section 9).

Figure 1: A framework for safety measurement and monitoring[24]

24
Vincent and colleagues suggest 10 guiding principles for safety measurement and
monitoring.
1. A single measure of safety is a fantasy.
2. Safety monitoring is critical and does not receive enough attention.
3. Approaches to safety should involve anticipation and be proactive.
4. Integration and learning: Invest in technology and expertise in data analysis.
5. Map safety measurement and monitoring across the organisation.
6. Blend externally required metrics with local development.
7. Be clear about purpose when developing safety measures.
8. Empower health care professionals and devolve responsibility for developing
and monitoring safety metrics.
9. Regulators and the regulated must collaborate.
10. Beware of perverse incentives.

Transforming patient safety: a sector-wide, systems approach

Other authors echo the call to revisit patient safety concepts and approaches and renovate
PSRS.
The World Innovation Summit for Health (WISH) Patient Safety Forum 2015 makes the case
for a systems approach to patient safety.[41] The authors state that the goals of patient
safety must be clearly stated, designed throughout the health care sector, and woven into
health care system operations. This approach also needs to use tools (or enablers) to move
health care from its current state into one that has eliminated preventable harm (including
metrics), as well as to address system-level gaps (including risk assessment) (see Box 4).

25
 Box 4: Enablers and system-level gaps for transforming patient safety[41]
Enablers System-level gaps
• Policy and regulation help 1. Holistic sector-wide approach: Patient safety
rather than hinder safety interventions must: evolve to work for the safety
improvements and keep up of the whole health system; be designed using a
minimum patient safety systems approach; be implemented using proven
standards. methods for large-scale organisational change; be
• Patient safety is a core value tailored to local cultures and resources; and align
of the culture. the perspectives of strategy, operation and
implementation.
• Leadership influences
2. System integrators: Health care must fully
patient safety at all levels of
embrace a disciplined approach to patient safety
health care.
that other industries have used. Each element of
• Education leads to informed patient safety, such as legal, regulatory and
decision-making and a technical systems, needs system integrators. In
resilient system. turn, these integrators must work together to
• Transparency and open create an overall integrated system of safety.
disclosure are professional 3. Risk assessment and performance reporting:
expectations. PSRS require comprehensive and methodical
• Metrics are used to evaluate analyses coupled with industry-wide learning and
progress and success. improvement, similar to programmes implemented
• Technology helps in providing in the aviation and transportation industries.
health care without 4. Patient safety regulation: Patient safety requires a
constraining it. regulatory body at the national or regional level that
• Patient safety is sustainable. has legal powers to strongly enforce the system,
along with standards of performance, robust data
• Patients and their families are
collection, and methodical analysis.
engaged partners in achieving
5. Cross-disciplinary science for safety: Research
patient safety.
laboratories for health care that combine basic and
• Patient safety research applied research and development involving
considers the different diverse fields of expertise must be created. Open
disciplines of health care. business models for communicating their findings
widely must also be supported.

Patient safety management models and systems

A 2011 Finnish report notes that safety concepts and how they are understood shape the
success of efforts to manage and improve safety in health care, as in any other sector
where safety is critical. Yet theoretical foundations are often unstated or unclear in patient
safety research and development. The authors clarify basic concepts related to patient
safety management as a first step towards developing a general model for patient safety
management.[42]
• Patient safety (the desired result of safety management) is an organisation’s ability to
function safely. Safety comes from the way social and technological factors interact in
an organisation. An organisation improves safety by creating good conditions for work,
rather than just by constraining performance.
• Safety model represents patient safety as a phenomenon affected by the system and
describes what makes a system safe or unsafe. A systemic approach considers both
successes and failures to be inevitable in organisational behaviour. It emphasises non-

26
 linear interactions, in which many parties and actions can contribute to an event at
many different parts of a sequence.
• Safety management model should be in line with both the definition of patient
safety and the safety model. It identifies the elements necessary to manage and
improve patient safety. An organisation should consider safety together with the
overall management of the organisation.
• Safety management system consists of the systematic organisational processes
needed to steer the organisation to ensure and develop safety. An organisation must
make it part of its management approach. It aims at both assessing and eliminating risks
and ensuring the organisation has appropriate conditions for safety throughout its
lifetime. It takes into account the specific characteristics of the organisation.

Renovating the NRLS and ideas for other national reporting

systems
The NRLS Research and Development programme report describes the current state of
patient safety incident reporting in the National Health Service. Building on NRLS research,
it also suggests how systems like the NRLS can take advantage of developments in
technology and understanding of human behaviour.[35]
The authors suggest improving the NRLS and related local reporting systems in the
following ways.
• Differentiate national from local systems. At a national level, creating a working
incident reporting system is an end in itself but in local systems it can also be a
means to support a relevant learning system.
• Provide data about frequent incidents to local improvement bodies, which should
continue to collect data on, assess and respond to common patient safety incidents
(‘casting the net wide and shallow’).
• Specify a limited number of incidents for which reports will be collected nationally
and collect structured and free-text data about them through a web portal.
• Nationally track patient safety incidents in priority areas like primary care, mental
health and community care.
• Improve the reporting functions with features such as user-friendly interfaces, effective
incident classification systems and new technologies for better platforms, feedback and
analytics.
In future, incident reporting systems should use digital resources such as smartphone
technology, so that staff can report in near real-time using a device they are accustomed to.
From there, the organisation could then store this information in a Cloud-based system. It
will also be important to build new systems based on behavioural insights from user-centred
design with the aim of limiting the burden on staff and reducing human error. Designing a
reporting system that invites staff to use it will be paramount (for example, making reporting
interfaces visually pleasing, and providing an approachable amount of text and question
fields). By taking advantage of these technological developments, the NRLS will be better
placed to modernise and engage people more strongly in the reporting process. Box 5 briefly
describes CareReport, a prototype, app-based incident reporting system that the authors of
this report developed.

27
 Box 5: CareReport[35]
• Provides a platform for collecting and storing staff
reports about patient safety incidents, including a
feedback loop between reporters and risk managers.
• Works online but has also been designed to operate as
an app for smartphones or tablets capable of offline
reporting.
• Requires a significantly reduced number of fields
for reporters to complete.
• Has an interface based on behavioural insights to limit
scope for human error and confusion (for example, the
data is presented as a scroll-down menu rather than in
free-text boxes). It includes a free-text box to allow
reporters to give further details of the event.
• Uses natural language processing to automatically
classify events described in free-text boxes based on
a defined taxonomy.
• Provides a dashboard feature that automatically feeds is
fed into an analysis system, which in turn can produce
easy-to-understand graphs and charts.
• Directs learning from local safety initiatives to a national
shared learning platform.

This brief overview of emerging thinking on patient safety and its management reminds us
of the critical importance of a systems approach to patient safety and the need to see
patient safety reporting in the context of a wider patient safety management system. It
provides us with new ways of thinking about, understanding and measuring patient safety
that better reflect the realities of today’s health care systems and the role of patients. Finally,
in view of all the work involved in renovating the United Kingdom’s patient safety
management system, it highlights and reinforces the critical issues for national-level PSRS.

28
11. Summary and key messages
This scan of overseas literature has explored a wide range of topics relating to patient safety
reporting. It began by describing the introduction of PSRS to health care systems around the
world and the challenges that have emerged since then: there is a shortage of evidence that
PSRS are effective; PSRS objectives are unclear; PSRS are receiving large volumes of
reports but these seem to be producing little action; and people face barriers to reporting. By
setting out the characteristics of successful PSRS, outlining the role of national PSRS as
distinct from local PSRS and detailing best-practice approaches to national and local PSRS,
this report has highlighted some possible solutions to the challenges for PSRS and has
answered some questions about PSRS. From the discussion of new ways of thinking about
patient safety, coupled with information about approaches in other jurisdictions and planned
directions, it further indicates how patient safety measurement might develop in the future.
The following clear directions have emerged from this review.
• Be clear about the distinct yet complementary roles of national versus local PSRS and
design systems that take account of these different roles.
• Be clear about what role of a particular patient safety reporting system is. In particular,
identify whether its primary focus is on learning or on reporting and accountability.
• Prioritise reports submitted at national level and, at both national and local
levels, prioritise degree/level of investigation.
• Improve feedback. This is a critical dimension of a learning system and essential
for motivating reporting.
• Take full advantage of new digital technologies, electronic health records and
understanding of human behaviour to make reporting easier and more engaging and to
improve the quality and effectiveness of data transfer and information sharing.
• Re-orient PSRS to put patients and their experience of health and the health care
system at the centre.
This report has presented findings of a limited scan of overseas literature. It has not been
possible to address all relevant aspects of the wider topic and some of the topics it has
addressed broadly would benefit from more in-depth investigation.

29
References
1. World Alliance for Patient Safety. 2005. World Health Organization Draft Guidelines
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32
Appendix A: Patient safety reporting systems in overseas jurisdictions
United Kingdom Scotland[43,44] Denmark[44] British Columbia, EU Member States[22]
(England and Canada[44]
Wales)[44]
Name of National Reporting and No national PSRS Danish Patient Safety No national PSRS for
system Learning System NHS regional boards Database (DPSD) adverse events
(NRLS) use standalone patient DPSD administered by BC Patient Safety and
Patient Safety Domain safety management National Agency for Learning System
of NHS England system Patients’ Rights and (PSLS) (provincial)
oversees the NRLS; National Framework Complaints
The Imperial College provides national (independent
Healthcare NHS Trust* approach to support government institution;
administers it providers to effectively also maintains
manage adverse complaints and
events; NHS boards compensation cases
are expected to adopt systems – the three are
this Framework not linked)
Reportable Any unintended or No common definitions Specified adverse All patient safety Definitions vary across
incidents unexpected incident National Framework: events incidents including Member States –for
that could have led to -All events that could Includes near misses adverse events, near example:
harm (near miss) or did have resulted in misses, safety hazards, - severity of incident
lead to harm for one or harm (near misses) patient complaints and (Norway)
more patients receiving or did result in harm claims - incident type
NHS-funded health to people or groups (Hungary)
care of people (patients, - combination of
Includes never events service users, staff) incident severity
Actual (not potential) -Includes clinical and and type (Denmark
level of harm must be non-clinical events and Italy)
reported - near misses only
Serious incidents (Germany)

33
 United Kingdom Scotland[43,44] Denmark[44] British Columbia, EU Member States[22]
(England and Canada[44]
Wales)[44]
(includes never events) -broadly defined
must be reported on (NRLS)
Strategic Executive
Information System
and to the Care Quality
Commission via the
NRLS
Requirement Voluntary Voluntary Mandatory for specified Voluntary Mix of mandatory and
to report Mandatory for serious Specific adverse events adverse events for Mandatory for serious voluntary systems
incidents required to be reported health professionals events
NHS organisations to national or UK-level (provided for in
‘obliged’ to report systems legislation)
patient safety incidents National Framework
to NRLS -Mandatory for
specified events for
NHS boards
People who Health professionals Health professionals Health professionals Health professionals Varies: health
report Health organisations Patients and relatives Patients and relatives professionals, health
organisations, patients,
Patients and relatives
relatives, public
Public
Mode of Anonymous and Anonymous reporting Anonymous reporting Anonymous reporting Different approaches to
reporting confidential (NHS trust available in some NHS available but available but keeping incidents
identifier maintained) boards discouraged; discouraged; identifying confidential and
identifying oneself seen oneself seen as anonymous
as expression of expression of
confidence in 'just confidence in 'just
culture' and the culture' and the
reporting system reporting system

34
 United Kingdom Scotland[43,44] Denmark[44] British Columbia, EU Member States[22]
(England and Canada[44]
Wales)[44]
Incident Own classification No common Danish classification Modified version of Several Member States
classification system, closely aligned classification system, similar to International draw on International
with World Health National Framework: International Classification for Classification for
Organization’s Classification for Patient Safety Patient Safety
- Incidents
International Patient Safety
categorised on
Classification for impact of harm: (1) Categories of severity:
Patient Safety permanent harm; no harm, mild harm,
Incident types (2) temporary harm; moderate harm,
classified into (3) no harm serious harm, death
categories (eg, patient
accident, treatment,
procedure) and by
degree of harm (no
harm, mild, low,
severe, death)
Report form e-forms for health National Framework: Electronic Patient’s view Data sets exchanged
professionals, the - Electronic between local and
patients and public - Minimum central level PSRS vary
information set across Member States
but data set outlined in
Table 4 is usually the
minimum
Incident Local analysis Local analysis by NHS Local analysis Most Member States
analysis All serious incidents boards National Agency for use an epidemiological
investigated through National Framework: Patients’ Rights and analysis model,
Patient Safety Domain, - All adverse events Complaints: including root cause
including incidents that subject to review - Analyses more analysis
offer potential for - Guidance provided serious incidents at
national learning or on level of review national level
represent new or and review process - Conducts specific

35
 United Kingdom Scotland[43,44] Denmark[44] British Columbia, EU Member States[22]
(England and Canada[44]
Wales)[44]
emerging risks (including analyses based on
standardised alerts and special
approach to writing focus areas
adverse event
review reports1)
Human factors
approach emphasised
Data transfer Online reporting direct No national Online; direct to the Online reporting to Almost all Member
from local to to NRLS or through measurement around national database central database States have online
national PSRS local NHS organisation adverse events Reports are reporting, often in
(reports can be automatically combination with paper
uploaded from local forwarded to the county reporting. Hungary has
risk management where the event a reporting app that can
systems to NRLS or occurred, where be used on any
submitted via NRLS e- reports are recorded, internet-enabled device
form) analysed and de-
identified, and to the
National Board of
Health, which keeps a
register of adverse
events
Care settings Available to NHS- NHS boards only Available across care Available across care Some Member States
funded health care National Framework: spectrum, including spectrum, including include care settings
organisations, including -Intention to cover all private providers private providers other than hospitals
primary care and
care settings
pharmacies (initially focused on
acute care)

1 www.healthcareimprovementscotland.org/our_work/governance_and_assurance/management_of_adverse_events/adverse_events_consultation1.aspx

36
 United Kingdom Scotland[43,44] Denmark[44] British Columbia, EU Member States[22]
(England and Canada[44]
Wales)[44]
Other data Data sharing NHS boards share Data sharing Participation
sources agreements information with agreements agreements between
NRLS data triangulated different national and PSLS and health
with other data sources UK agencies authorities govern data
flows
Learning Safety alerts (shared Safety alerts Safety alerts Safety alerts
via National Patient No national reporting Various information Various reports
Safety Alerting System) Community of Practice sharing channels used published through BC
Organisational-level aims to share tools and by DPSD PSLS publications
patient safety incident key learnings from Danish Patient Safety My Reports supports
reports adverse event reviews Agency required under quick analysis of
NRLS data published legislation to share incidents and issues
online learnings from system Online blog available to
Plans to report never nationally and with the public
events six-monthly other agencies
Other NHS England Patient National Framework Focus on ‘just culture’, Focus on ‘just culture’,
Safety Concern promotes a just and supported in legislation supported in legislation
process – framework to positive safety culture Danish health system PSLS comprises online
share and manage Community of Practice supplements patient modules and tools:
patient safety website supports safety information from Safety Events (primary
concerns, as identified sharing of good DPSD with other tools module); Complaints;
by Patient Safety practice and methods (eg, Claims; Safety Alerts;
Domain, at regional audits using IHI Global Risk Register;
level Trigger tool, patient Recommendations
Quality Surveillance safety walkarounds)
Groups coordinate
patient safety
intelligence
National Patient Safety

37
 United Kingdom Scotland[43,44] Denmark[44] British Columbia, EU Member States[22]
(England and Canada[44]
Wales)[44]
Alerting System
(NPSAS) alerts NHS
organisations to risks
and provides guidance
on potential patient
safety incidents
Developments Patient Safety Incident Long-term aspiration to Approach to National System for
Management System have a national system information and Incident Reporting
project – redeveloping for sharing learning knowledge sharing is (which collects
patient safety from adverse events under review; medication incident
management system, National Information Knowledge Platform data) is expected to
due 2016/17 and Intelligence being developed expand to provide
Healthcare Safety Framework for Health Canada-wide adverse
Investigation Branch, and Social Care – event reporting system
operating since April Scottish government’s Working on
2016, offers support strategic framework for development of
and guidance to NHS sharing patient safety indicators for patient
organisations on data and intelligence safety-related
investigations, and for 2014 to 2020 measures
carries out certain
investigations itself
Work underway to
support non-acute
sectors of health care
to report more
* The National Patient Safety Agency, which has recently been disestablished, previously managed the NRLS. NHS England’s Patient Safety Domain
has taken over its key functions.

38
Appendix B: Five general modes of feedback for incident reporting systems,
with examples
Mode Type Content and examples
A. Bounce back Information to reporter Acknowledge report filed (eg, automated response)
Debrief reporter (eg, telephone debriefing)
Provide advice from safety experts (feedback in issue type)
Outline issue process (and decision to escalate)
B. Rapid Action within local Measures taken against immediate threats to safety or serious issues that have been marked for
response work systems fast-tracking
Temporary fixes/workarounds until in-depth investigation process can be completed (withdraw
equipment; monitor procedure; alert staff)
C. Raise risk Information to all Safety awareness publications (posted/online bulletins and alerts on specific issues; periodic
awareness frontline personnel newsletters with example cases and summary statistics)
Highlight vulnerabilities and promote correct procedures
D. Inform staff of Information to reporter Report back to reporter on issue progress and actions resulting from their report
actions taken and wider reporting
Widely publicise corrective actions taken to resolve safety issue to encourage reporting (eg, using
community
visible leadership support)
E. Improve work Action within local Specific actions and implementation plans for permanent improvements to work systems to address
systems safety work systems contributing factors evident in reported incidents
Changes to tools, equipment, working environment, standard working procedures, training
programmes etc
Evaluate and monitor effectiveness of solutions and repeat
Source: NIHR Imperial Patient Safety Translational Research Centre. 2016. NRLS Research and Development. A report prepared for NHS England. URL:
www.imperial.ac.uk/media/imperial-college/institute-of-global-health-innovation/IMPJ4219-NRLS-report_010316-INTS-WEB.pdf (accessed 18 June 2016).

39
Appendix C: Fifteen system requirements for effective safety feedback
for incident reporting
1. Feedback at multiple levels of the organisation or system
2. Appropriateness of mode of delivery or channel for feedback
3. Relevance of content to local work place and systems
4. Integration of feedback within the design of safety information systems
5. Control of feedback and sensitivity to information requirements of different user groups
6. Empowering frontline staff to take responsibility for improving safety in local
work systems
7. Capability for rapid feedback cycles and immediate comprehension of risks
8. Direct feedback to reporters and key issue stakeholders
9. Feedback processes are established, continuous, clearly defined and
commonly understood
10. Integration of safety feedback within working routines of frontline staff
11. Improvements made within local work systems are visible
12. Frontline personnel consider the source and content of feedback to be credible
13. Feedback preserves confidentiality and fosters trust between reporters and
policy developers
14. Visible senior-level support for systems improvement and safety initiatives
15. Double-loop learning to improve the effectiveness of the organisation’s safety-
feedback process
Source: NIHR Imperial Patient Safety Translational Research Centre. 2016. NRLS Research and Development. A report prepared for NHS England. URL:
www.imperial.ac.uk/media/imperial-college/institute-of-global-health-innovation/IMPJ4219-NRLS-report_010316-INTS-WEB.pdf (accessed 18 June 2016).

40
Appendix D: Framework for safety action and information feedback from
incident reporting

Source: NIHR Imperial Patient Safety Translational Research Centre. 2016. NRLS Research and Development. A report prepared for NHS England. URL:
www.imperial.ac.uk/media/imperial-college/institute-of-global-health-innovation/IMPJ4219-NRLS-report_010316-INTS-WEB.pdf (accessed 18 June 2016).

41
Appendix E: Analysis of safety along the patient
journey

Source: Vincent C, Amalberti R. 2016. Safer Healthcare: Strategies for the real world. URL:
http://link.springer.com/book/10.1007/978-3-319-25559-0 (accessed 16 June 2016).

42