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APPENDIX

AUSTRALIA……………………………………………………40Background…………………………………………………………………….…..40System of Government……………………………………………………………………………….40Description of Health Care System …………………………………………………………………40Intergovernmental Relations………………………………………………………………………….40

National Initiatives…………………………………………………………………42 Australian Patient Safety Foundation 1989…………………………………………………………42Review of Professional Indemnity Arrangements for Health Care Professionals 1991-95……42Task Force on Quality in Australian Health Care 1995-96………………………………………..42National Expert Advisory Group on Quality and Safety 1996-99…………………………………43

Australian Health Care Agreements 1998-2003……………………………………………………44

National Quality/Patient Safety Strategy 1998-99………………………………………………….45 Australian Council for Safety and Quality in Health Care 2000…………………………….…….46Commonwealth Health Occasional Paper on Quality 2000………………………………………49National Institute of Clinical Studies 2001…………………………………………………………..50

State/Territorial Initiatives………………………………………………………..51New South Wales……………………………………………………………………………………...51Victoria…………………………………………………………………………………………………..56Queensland……………………………………………………………………………………………..61Western Australia………………………………………………………………………………………64

Australian Capital Territory……………………………………………………………………………65

Error Reporting Systems and Data Analysis…………………………………68 Australian Incident Monitoring System (AIMS)……………………………………………………..68NSW Performance Indicators………………………………………………………………………...70Victoria Clinical Incident Reporting…………………………………………………………………..70Victoria Sentinel Event Reporting and Root Cause Analysis……………………………………..70Queensland Incident Monitoring……………………………………………………………………..70Western Australia Computerized Incident Management System………………………………...70

ACT Adverse Event Incident Monitoring System…………………………………………………..70Data Reporting and Analysis…………………………………………………………………………71

Public and Media Opinion………………………………………………………..72 Australian Patient Safety Survey 2001……………………………………………………………...72Medical Error Action Group…………………………………………………………………………...73Former President, Australian Medical Association…………………………………………………73The Australian Commentary………………………………………………………………………….73

Regulatory, Legal and Insurance Issues………………………………………75 Qualified Privilege……………………………………………………………………………………...75Malpractice Insurance Issues…………………………………………………………………………77Role of Professional Governing Bodies……………………………………………………………...80Complaints Commissions……………………………………………………………………………...80



37

Gaps…………………………………………………………………………………… 81Reporting………………………………………………………………………………………………… 81Primary Care…..………………………………………………………………………………………. 81Private Hospitals Excluded……..………..…………………………………………………………… 81

Future Plans….…………..…..……………………………………………………… 82

Australian Health System Safety Surveillance Unit……….………………………………………… 82National Database for Medical Negligence Claims……………………………………………….. 82Safety and Quality Council Medication Safety Standards and Guidelines……………………….. 82Safety and Quality Council Review of Regulatory Barriers to Safety……………..……………… 82Chronology of Australian Patient Safety Initiatives……………………………………………………83

United Kingdom..……………………………………………. 84Background………….…………………………………………………………….. 84System of Government……………………………………………………………………………….. 84Health Care System………………….………………………………………………………………… 84

Reports and Inquiries…………………………………………………………….. 86

A First Class Service: Quality in the new NHS – 1997…..………………………………………… 86Supporting doctors, protecting patients – 1999…………………………………………………….. 86

An organization with a memory – 2000….………………………………………………………..… 87 Assuring the Quality of Medical Practice – 2001………….………………………………………… 90Building a safer NHS for patients: Implementing an organization with a memory – 2001..………91 Appraisal for consultants working in the NHS – 2001….…..……………………………………….. 91Handling clinical negligence claims in England – 2001………………………………………………91

A Commitment to Quality, a Quest for Excellence – 2001..………………………………………….92Bristol Royal Infirmary Inquiry: Final Report – 2001………..………………………………………...92Doing Less Harm: Improving the safety and quality of care through reporting, analyzing andlearning from adverse incidents involving NHS patients – 2001…………………………………… 94Learning from Bristol: The Department of Health's Response - 2002. ……………………………. 94

National Initiatives. ……………………..…………………………………………. 96Error Elimination/Reduction Targets…..……………………………………………………………… 96NHS Clinical Governance – Duty of Quality…………..……………………………………………… 97Commission for Health Improvement……….…..………………………………………………………98National Institute for Clinical Excellence.……………………………………………………………..100National Service Frameworks..………………………………………………..……………………… 100Clinical Risk Management Standards……………………………………………………………… 102 Annual Physician Appraisals…..………………………………………………………………………102National Clinical Assessment Authority…………...………………………………………………… 103National Patient Safety Agency..…………………………………………………………………… 104National Care Standards Commission…………………………………………………………….. 105NHS Patient Safety Research Program……………………………………………………………. 105

Error Reporting Systems and Data Analysis…..………………………………106 An Organisation with a Memory…..……………………………………………………………………106 Building a safer NHS for patients………………………………………………………………………106Doing Less Harm………..………………………………………………………………………………106Pilot Project……..……………………………………………………………………………………….109



38

Public and Media Opinion…………………………………………………………111 Action for Victims of Medical Accidents…….…………………………………………………………111

Media Coverage……..………………………………………………………………………………….111

Regulatory, Legal and Insurance Issues…………………………….…………112Malpractice Insurance Issues………………………………………………………………………….112

Patient Complaints……………………………………………………………………………………...117Role of Professional Governing Bodies………………………………………………………………118Qualified Privilege………………………………………………………………………………………119

Gaps…………………………………………………………………………………..120

Future Plans…………………………………………………………………………121 Announcements Made in Response to Bristol Inquiry………………………………………………121Other Future Initiatives………………………………………………………………………………….122

UNITED STATES…………………………………………….123Background…………………………………………………………………………123Health Care System……………………………………………………………………………………123

Reports and Studies…………………………………………………….…………124Harvard Medical Practice Study……………………………………………………………….………124To Err is Human………………………………………………………………………………………...124Doing What Counts for Patient Safety ………………………………………………………….…….127Making Health Care Safer ……………………………………………………………………………..127Crossing the Quality Chasm: A New Health System for the 21st Century……………………….128

National Initiatives…………………………………..……………………………. 130Targets……………………………………………………………….…………………………………. 130

Quality Interagency Coordination Task Force……………………………………………………….131 Agency for Healthcare Research and Quality……………………………………………………….132 AHRQ Research Program……………………………………………………………………………..133Veterans Administration………………………………………………………………………………..134Joint Commission on Accreditation of Healthcare Organizations…………………………………134National Patient Safety Foundation…………………………………………………………………..136Leapfrog Group…………………………………………………………………………………………136MedWatch……………………………………………………………………………………………….137Institute for Safe Medication Practices……………………………………………………………….138National Quality Forum…………………………………………………………………………………139Patient Safety Institute…………………………………………………………………………………140

State Initiatives……………..……………………………………………………… 141

California…………………………………………………………………………………………………141Massachusetts…………………………………………………………………………………………..141Minnesota………………………………………………………………………………………………..142Pennsylvania…………………………………………………………………………………………….142Rhode Island…………………………………………………………………………………………….143Texas……………………………………………………………………………………………………..143Wisconsin………………………………………………………………………………………………..144Virginia …………………………………………………………………………………………………..144



39

Error Reporting Systems and Data Analysis…………………….…………….145

Public and Media Opinion…………………………………………………………146Commonwealth Fund Patient Survey…………………………………………………………………146Pushing the profession: how the news media turned patient safety into a priority ……………...146

Regulatory, Legal and Insurance Issues……………………………………….147Malpractice Insurance…………………………………………………………………………………..147Qualified Privilege……………………………………………………………………………………….149

Assessments of Patient Safety Initiatives……………………………………..150Making Health Care Safer …………..………………………………………………………………….150The Challenge of Assessing Patient Safety in America's Hospitals……………………………….151

Gaps…………………………………………………………………………………..154Hospital Focus…………………………………………………………………………………………...154Reporting is Largely Voluntary…………………………………………………………………………154Lack of Overall Coordination…………………………………………………………………………..154

Commission But Not Omission………………………………………………………………………...154Self-Identified Gaps……………………………………………………………………………………..154

Future Plans…………………………………………………………………………155 AHRQ Patient Safety Program Evaluation Centre…………………………………………………..155

Endnotes……………………………………………………………………………..156



APPENDIX to: Governments and Patient Safety in Australia, the United Kingdom and theUnited States - August 2002

40

AUSTRALIA

BACKGROUND

System of Government

Australia is a federal state with 6 States and 2 Territories. The Constitution givesthe Commonwealth (federal) Parliament specified powers; all other powersreside at the state and territorial level.

Description of Health Care System

There are overlapping responsibilities for funding and delivering health care

services:

The Commonwealth currently has a leadership role in policymaking and particularly innational issues like public health, research and national information management.

The States and Territories are primarily responsible for the delivery and management of public health services and for maintaining direct relationships with most health care providers, including the regulation of health professions.

The States and Territories deliver public acute and psychiatric hospital services and awide range of community and public health services including school health, dentalhealth, maternal and child health and environmental health programs.

The State and Territory governments directly fund a broad range of health services. TheCommonwealth funds most medical services out of hospital, and most health research.The Commonwealth, States and Territories jointly fund public hospitals and communitycare for aged and disabled persons.

i

Australia has both public and private health care, with private insurance (or out-of-pocket) covering private hospital services and physicians opted-out ofMedicare. The latter accounts for 30% of health expenditure.

Intergovernmental Relations

Australian Health Ministers’ Conference

The Australian Health Ministers’ Conference (AHMC) is the senior coordinatingbody for health policy matters. Over the years, it has commissioned andreceived several reports on patient safety and quality issues.




41

For example, in August 1999 it agreed to the establishment of the AustralianCouncil for Safety and Quality in Health Care. In August 2001 the conferencereceived and endorsed the Council's annual report.

Australian Health Ministers’ Advisory Council

The Australian Health Ministers' Advisory Council (AHMAC) is the primarynational advisory body reporting to the AHMC, and facilitates governments'participation in national programs, thereby achieving a degree of uniformity. Themembers are the Heads of the Health authorities of the Federal, State andTerritory Governments.




42

NATIONAL INITIATIVES

Australian Patient Safety Foundation 1989

The Australian Patient Safety Foundation (APSF) was founded in 1989,preceding its American counterpart by eight years. Membership is open to allindividuals and organisations with an interest in patient safety. It hasrepresentatives on its Council from medical and other health care colleges andthe Consumers’ Health Forum, a national advocacy group.

The Foundation states that, "Simply being a patient in an acute care hospital in Australia carries, on average, a 40-fold greater risk of dying from the careprocess than from being in traffic, and 400-fold greater risk than working in thechemical industry." ii It notes that the cost of adverse events exceeds $2 billionper year. On a more positive note, the article says, "It may be estimated that as

much as half of the cost of this burden to society may be removed within 5 - 10years if the necessary investments are made in a systematic approach to thisproblem".

APSF initially arose to address anaesthesia safety issues. Its main focus hasbecome the

Australian Incident Monitoring System (AIMS), Australia's first monitoring system. AIMS arose to fill a need of the Professional Indemnity Review, described below.

Review of Professional Indemnity Arrangements for Health CareProfessionals and Quality in Australian Health Care Study 1991-1995

This review (“PIR”) was the earliest government initiative that prompted concernsabout patient safety. In an effort to obtain data about the incidence of adverseevents, it commissioned the Quality in Australian Health Care Study , which usedthe Harvard Medical Practice Study methodology. The Australian studysuggested that there were likely around 230,000 preventable adverse events in

Australian hospitals each year, that 30,000 people suffered a permanentdisability of some kind, and that between 10,000 and 14,000 people diedbecause of the preventable adverse event.

The PIR is described in more detail later.

Task Force on Quality in Australian Health Care 1995-1996

The release of the results of the Quality in Australian Health Care Studyprompted the Australian Health Ministers Conference of 1995 to establish thistask force. Its terms of reference were:




43

• Assess and assign priorities to the leading causes of adverse events and suggeststrategies able to be implemented immediately to address them;

• Recommend measures to improve the management of quality of care and hospitalsincluding ways in which patient records and other relevant data can be routinely reviewedand problems identified and acted on;

•

Recommend indicators to be used to monitor quality of care in Australian hospitals andsuggest priorities for the development and use of protocols relating to diagnosis andtreatment;

• Propose changes in health care professional education and training that may reduce theincidence of adverse events;

• Recommend other measures that may reduce the incidence of adverse events in thehealth system, both in and out of hospitals;

• Recommend further analysis or research to identify and improve control of preventableadverse events. iii

The Task Force estimated that preventable adverse events were costing the

Australian health care system an estimated $867 million per year. This is basedon an adverse event ratio of 16.6 percent in Australian hospitals; that wouldaccount for 3.3 million bed days, 1.7 million of which could be classified as“highly preventable”. The $867 million did not include litigation costs, settlementcosts, ongoing disability costs, or loss of productivity.

The Task Force made 56 recommendations in its 1996 final report. The keyrecommendations were:

• a Statement of Health Care Safety and Quality Principles be agreed upon

• a Safety and Quality in Health Care Council be established

• pilot projects continue to be funded

• a “generic occurrence classification” of adverse patient events be developed

• hospital accreditation become mandatory

• $3 million be invested in clinical guideline development

• health professional bodies develop recertification programsiv

The Task Force estimated that the implementation cost for the Safety and QualityCouncil would be $166.3 million over five years. An additional $152.4 millionwould have to be spent by hospitals. The Task Force noted that these costs

would be more than offset by savings from avoided adverse events.

National Expert Advisory Group on Quality and Safety 1996-1999

Australian Health Ministers established the National Expert Advisory Group onSafety and Quality in Australian Health Care (NEAG) in October 1996 followingreceipt of the recommendations of the Task Force on Quality in Australian Health




44

Care. NEAG’s role was to advise Health Ministers on mechanisms forenhancement of the quality of Australian health care.NEAG issued an interim report in April 1998 v and a final report in July 1999 vi. Inits final report, NEAG observed:

The Expert Group considers that the Australian health care system needs to embrace a"beyond blame" culture, whereby the responsibility for safety and quality improvementrests not with individuals, but with agencies, organizations and governments.

vii

NEAG identified 10 "national actions":

1. Support methods to enable increased consumer participation in health care.

2. Facilitate implementation of evidence-based practice.

3. Develop strategies and partnerships to improve information flows between all partiesabout areas for quality improvement, and to ensure that patients, their families andcareers and health care agencies receive timely advice about incidents.

4. Develop legislative changes that will allow the detailed, thorough investigation ofadverse events or "near misses" and the timely reporting of findings for theinformation of consumers and for action by organizations and health care providersin the system.

5. Facilitate agreement on common systems for the collection and analysis ofincidents, adverse events and complaints.

6. Develop a national framework for health service performance measurement andreporting.

7. Facilitate improvements in the quality of current accreditation mechanisms thataddress the safety and quality of the system in operation.

8. Facilitate improvements to the design and management of the health system that promotes smoother transitions for consumers across health service boundaries.

9. Research and develop clinical and administrative information systems that have asystem-wide focus and application.

10. Agree on national requirements for education and training for all health care providers to support their involvement in quality management and collaborativeapproaches to health care delivery.

viii

NEAG also reiterated the Task Force’s recommendation that a Safety andQuality Council be established. It recommended that governments provide $17.4million over four years to support the implementation of the “national actions” andto establish the Safety and Quality Council.

Australian Health Care Agreements 1998-2003

The Commonwealth government contributes to medicare funding. Thebreakdown of health expenditure is: Commonwealth government, 47%; stategovernments, 23%; and non-government, 30%. ix These funds are transferred toState/Territorial governments on the basis of a new mechanism, Australian




45

Health Care Agreement s. The first agreements cover the period from July 1,1998 to June 30, 2003.

The agreements cover more than just funding, and include a section on “QualityImprovement and Enhancement”. There is standard wording in all the

agreements on quality and safety issues:

The Commonwealth and [state/territorial government] agree that there is a need fornational commitment, in partnership with clinicians and consumers, to health care safetyand quality improvement and recognize that there are some safety and quality issueswhich are best dealt with at the national level.

x

The Agreements also require that:

The State Minister and the Commonwealth Minister will jointly agree, in the first grantyear of the Agreement, a Strategic Plan to advance quality improvement andenhancement of public hospital services during the term of this agreement xi

These State/Territorial Strategic Plans are described below in the State Initiatives section.

An attempt was made in 1998-99 to define what would be best dealt with at thenational level. The role of the Commonwealth was defined as:

• direct role in fostering the collaborative relationship between states/territories, national peak bodies, professional colleges, health educators and others on these issues; and

• supporting the development of national frameworks for integrating, connecting, andfostering innovation in health service quality.

The role of the States/Territories was defined as:

• Managing the delivery of quality health care services; and

• Building on the quality initiatives established by other jurisdictions and facilitating thedissemination of best practice.

xii

The Agreements specify that Commonwealth funds can be allocated to statesand territories to support quality improvement and enhancement programsthroughout the life of the Agreements. The Commonwealth government hasallocated approximately AUS$660 million across Australia for quality and safety

initiatives.xiii

National Quality/Patient Safety Strategy 1998-99

An initial multilateral meeting between the Commonwealth, states and territoriesagreed on the following goals:




46

1. Consumer/Community Involvement in Decision Making

2. Fostering Clinical Best Practice

3. Measuring Quality and Outcomes

4. Strengthening Accreditation

5. Promoting Accountability for Quality6. Enhancing Innovation

7. Supporting Information Systems for Quality xiv

Australian Council for Safety and Quality in Health Care 2000

The outcome of the recommendations of the Task Force and Expert Group wasthe establishment in 2000 of the Council for Safety and Quality in Health Care,generally known as the Safety and Quality Council . It is the senior Australianbody.

The Council has 22 members, 10 of whom are identified as professors. Twelveare physicians. Most members wear at least two hats. For example, they haverelated positions as:

• Chair, Australian Patient Safety Foundation

• Past President, Australian Medical Association• Chief Medical Officer, Commonwealth Department of Health• Head, National Institute of Clinical Studies• Chief Medical Officers of State Governments• Chair, State Quality Committee

• Head, National Health and Medical Research Council

Also on the Council are hospital administrators, nurses, consumers, and alawyer.

The Council receives advice and assistance from the State Quality OfficialsForm, a body the Council created.

The Council's role is, “To lead national efforts to promote systemic improvementsin the safety and quality of health care in Australia with a particular focus onminimizing the likelihood and effects of error". xv

The Council's tasks are to:

1. Provide advice to Health Ministers on national strategy and priority areas for safety andquality improvement

2. Develop, support, facilitate and evaluate national actions in the agreed priority areas






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Papers and Reports

The Council has also recently published numerous papers and reports, including:

• Core Standards for Health Care Safety: Consultation Paper

• Credentials and Clinical Privileges Guidelines: Working Draft forConsultation

• A Draft Model for Medical Registration -- for consultation

• Public Interest in Health Care Qualified Privilege: Issues Paper in Safety inNumbers: A Technical Options Paper for a National Approach to the Useof Data for Safer Health Care: Work in Progress

• Safety First: Report to the Australian Health Ministers Conference, 27 July

2000• Safety in Practice: Making Health Care Safer: Second Report to the

Australian Health Ministers Conference, 1 August 2001

Three of these papers deal with institutional accreditation, professionalregistration and renewal, and the granting of hospital privileges. These aredescribed below.

Core Standards for Health Care Safety: Consultation Paper

The paper observes about current accreditation processes:

… many people … believe, almost certainly incorrectly, that when they see that a facilityhas been accredited that it equates with an assurance that health care is providedsafely….

xix

This paper proposes the development and implementation of core safetystandards for use in external assessments of health care provider institutionssuch as hospitals. The paper proposes a development model:

To ensure an appropriate evidence base and a clear link with safety, the development ofcore safety standards should be led by professionals qualified and experienced in theevaluation of clinical research, evidence-based medicine and standards development.The National Institute of Clinical Studies [described below] or the National Health andMedical Research Council may be in a position to contribute to this endeavour.

xx

The paper notes that there is competition in industry for audit services and that asimilar, non-monopolistic market should be developed for health care.




49

A Draft Model for Medical Registration August 2001

The Council has concluded that, “…there are significant gaps in the currentsystem of medical registration that expose the community to unacceptable risk”.xxi In particular, “… medical registration cannot be considered to be a current

statement of a doctor’s competence. Nor does it ensure that doctors only practicein an area of medicine in which they are demonstrably competent… medicalgraduates may be granted registration on completion of internship and have thisrenewed for 40 or 50 years without any commitment to maintaining and updatingtheir knowledge and skill”. xxii

The Council proposes that professional development and recency of practice bedirectly linked to renewal of medical registration. xxiii

Credentials and Clinical Privileges Guidelines

This paper proposes principles and processes for a national guideline ongranting and renewing institutional clinical privileges.

Some of the principles are:

• All professional health care providers will have their credentials and clinical privilegesreviewed at regular intervals

• The [institution’s] governing body will have systems in place for the early identificationand management of compromised performance including that relating to incompetentor impaired practitioners

xxiv

Commonwealth Health Occasional Paper on Quality 2000

The Commonwealth Department of Health and Aged Care published anOccasional Paper in 2000 titled,” The Quality of Australian Health Care: CurrentIssues and Future Directions.” xxv Although largely a literature review, it doesprovide a rationale for government involvement in quality and safety initiatives,outlining some quality themes and next steps.

The paper summed up the Australian context:

Improving quality represents a widely popular articulation of policy - as Leatherman andSutherland (1998) note, it is, after all, rare to find anyone who is opposed to the notion ofhigh quality. Within Australia, however, there has been little evidence that keystakeholders have a shared understanding of the concept of quality. There is anabsence of agreed standards and a lack of explicit, agreed national goals for qualityimprovement. In a complex health care environment, this has made it difficult to driveforward a meaningful and appropriately integrated national quality agenda. This situationhas been marked by continuing debate about the extent of the gap between existing andoptimal levels of safety and quality in the Australian health care system.

xxvi




50

The Paper says that governments’ roles should incorporate:

• "Whole system thinking" taking into account considerations of how continuingimprovement in quality and safety of health care are best built into system design andfinancing arrangements;

• building on the support of clinical professions recognizing that effective quality is criticallydependent on the support and involvement of those who provide services;

• strengthening the capacity of consumers to play an informed role in achieving health carequality (at all levels of the system);

• a greater focus on data support which promotes learning (at all levels of the system)rather than judgment; and

• building public confidence in the system through strong national commitment includingsupport for national mechanisms such as the Australian Council for Safety and Quality inHealth Care and the National Institute of Clinical Studies

xxvii

The paper also identifies "key focus areas":

• Systemic approaches to quality and safety improvement

• measuring overall performance of the health care system and its component parts

• examining unexplained variation in clinical practice

• concern about the safety of health care, in particular preventable errors

• looking at how financing approaches can best be used to support quality and safetyimprovement at the local level

• strengthening opportunities for consumer and community involvement

• ensuring that the health workforce is appropriately equipped xxviii

National Institute of Clinical Studies 2001

The new National Institute of Clinical Studies (NICS) has a mandate to "close thegaps between evidence and clinical practice, in those areas that will effectsignificant change for the Australian community" and to "facilitate cultural andattitudinal change in clinical practices". xxix

It is not NICS's role to develop and collate the evidence that will improve clinical practice.There are already a number of national and international health research bodies… thathave this responsibility. NICS does, however, need to work with these organizations to

develop and implement effective mechanisms for the transfer of this evidence intoimproved clinical care. xxx

The Commonwealth Government has committed $1.5 million to establish theInstitute and $3.5 million annually for three years to implement the Institute'sstrategic plan. The CEO of the Institute is on the board of the Safety and QualityCouncil.




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STATE/TERRITORIAL INITIATIVES

The table below summarizes state/territorial activities in patient safety.

NSW Victoria Queens-land

Western Aust.

South Aust .

Tasmania ACT NorthernTerritory

Quality Council ! ! ! ! ! Strategic Plan ! ! ! ! ! Area QualityCouncils

!

Quality Branch ! ! ReportingSystem

! Plan

Root Cause Analysis

!

Chart Review !

RiskManagement

! !

At this stage we have been unable to obtain information about South Australia,Tasmania and the Northern Territory. To qualify for Commonwealth quality andsafety funding they likely have established quality councils and have developedstrategic plans, but there are no web site references for them.

New South Wales

With a population of 6.5 million, New South Wales is the largest state. The state’s

patient safety initiatives are part of its efforts to increase the quality of care.

The key elements of NSW’s patient safety strategy are:

• A state-wide Council on Quality in Health Care o A “Safety” Working Party under the Council

• A Framework for Managing the Quality of Health Services in NSW • Area Quality Councils to implement and manage the framework• A NSW Health Quality Branch in the Department of Health

Council on Quality in Health Care

The state has had a Council on Quality in Health Care since 1996. The Councilreports to the Minister of Health. The Council's Terms of References are asfollows:

Role

• Provide leadership for improving the quality of health care in NSW.




52

• Provide advice and make recommendations as appropriate on any other matterconcerning the quality of health care as required by the Minister or Director-General.

Objectives

1. Liaise with relevant stakeholders to incorporate principles for improving health care in

relevant plans and policies at a State and national level

2. Oversee the activities of the Unit for Quality in Health Care through its business planning cycle

3. Incorporate the consumer perspective of quality health care into the work of theCommittee, in particular to provide recommendations about the routine availability ofmeaningful and useful information to health care consumers

4. Provide input and advice on the education and training requirements of health care professionals and managers and consumers

5. Provide advice on appropriate research and development activities for improvinghealth care

6. Recommend a systemic approach to reduce inappropriate variation in the use ofhealth services in NSW and the measurement and improvement of patient safetyusing selected quality of care indicators

7. Identify barriers to the implementation of evidence-based health care improvementstrategies and make recommendations as to how those barriers may be overcome

8. Review and recommend on the outcomes of quality measurement through theFramework process xxxi

The Council has 18 members, most of whom are physicians. Also included are anurse, a consumer, and a representative of the airline industry. The Council hasa Departmental Reference Group attached to it.

The Council has identified four priority areas in its work plan:

1. A systematic approach to reduce inappropriate variation in the use of health careservices in NSW.

2. Measurement and improvement of patient safety using selected quality of careindicators.

3. Identification of barriers to the implementation of evidence-based health careimprovement strategies.

4. Incorporation of the consumer perspective of quality health care into the work ofthe Council .

xxxii

The Council has a series of working parties, including one on "Safety". Theterms of reference of this working party are quoted below:




53

Role

The role of this working party is to develop a workplan for the Council by providing adviceand recommendations, consulting with stakeholders and reviewing the Council’s Termsof Reference.

Scope of Work

The "Safety" working party will look at the following area:

• Recommend measurement and improvement of patient safety using selectedquality of care measures

• Develop a framework for managing the safety of Health Services in NSW

• Recommend an implementation and research agenda designed to demonstratehow such a framework would operate. This should include a specific project thatcan be commenced in this financial year.

• Any other related matter that the working party believes is required by the particular Term of Reference

These recommendations should at least include information on the resource and time

considerations for the projects.Timeline

It is expected that the working party will be able to provide a final report to the Council,with recommendations for action, by May 2001. xxxiii

Framework for Managing the Quality of Health Services in NSW

In conjunction with NSW Health, the Committee on Quality in Health Caredeveloped A Framework for Managing the Quality of Health Services in NSW(the “Framework”). This report identifies "six dimensions of quality", the first ofwhich is “safety”. Safety is defined as:

A major objective of any health care system should be the safe progress of consumersthrough all parts of the system. Harm from their care, by omission or commission, as wellas from the environment in which it is carried out, must be avoided and risk minimized incare delivery processes.

xxxiv

The Framework includes a list of "characteristics" of a "quality oriented healthservice" that includes "an emphasis on preventing adverse outcomes throughsimplifying and improving the processes of care." Another characteristic is: "Arobust advisory and reporting structure designed to promote the qualityimprovement of health services and to provide regular information to the Area

Health Service Board on the quality of services provided."

xxxv

The Framework outlines the preconditions for improving patient safety:

Fundamental to the improvement in the level of safety for patients in the health system isa thorough understanding of error in health care including

• the mechanisms and causes of error

• the detection of error




54

• methods for minimizing and preventing error.

Substantial cultural change will be needed if health services are to make meaningful progress in error reduction. All health providers "need to accept the notion that error isinevitable accompaniment of the human condition, even among conscientious

professionals with high standards. Errors must be accepted as evidence of system flawsand not of character flaws". Attention must therefore be given to system changes to

reduce the risk of error or its consequences for the patient. xxxvi

Area Quality Councils

The Framework includes a proposal for Area Quality Councils that would be acommittee of the Area Health Service Board, the operating agency. The purposeof the Council would be to "define and, measure, monitor, improve, and report to,consumers, the clinicians and managers on the services, the Area Health ServiceBoard, the Department of Health, and to the Minister for Health."

NSW Health Quality Branch

The NSW Quality Branch was formed in November 1999.

Functions of the Quality Branch

• To provide assistance and direction, when required, to Area Health Services inimproving the quality of health care for the people in NSW;




55

• To provide project and administrative support services to the NSW Council onQuality in Health Care;

• To commission studies, projects and other work designed to improve the qualityof the health care;

• To assist Area Health Services in the implementation of A Framework for

Managing the Quality of Health Services in NSW.• To provide policy advice to the Minister for Health, the Director-General and the

Deputy Director-General, Public Health and Chief Health Officer, about quality inhealth care and about issues relating to the quality of health care;

• To provide active participation in appropriate NSW and national networks at thelevel of both individuals and organisations;

• To undertake appropriate tasks concerning health care quality as directed by theMinister for Health or the Director-General.

xxxvii

Quality of Care Indicator Reporting

As part of the implementation of the framework, Area Health Services are beingrequired to provide regular reports to the Quality of Health Care Unit in theDepartment of Health about the quality of health care they are providing. One setof indicators deals with safety. Reporting was to be phased in in three stages.The following chart illustrates the three phases:




56

NSW continues to develop its performance indicators. In a November 2000Report xxxviii, NSW reported that no safety indicators were available for immediateuse.

Victoria

With a population of 4.8 million Victoria is Australia’s second-largest state. In2001-2002 Victoria is introducing 5 new patient safety initiatives outlined in the Clinical Risk Management Strategy, 2001 xxxix (the “Strategy”), based on thereport Improving Patient Safety in Victorian Hospitals, September 2000 ,described below. The initiatives are:

1. Victorian Quality Council

2. Clinical Incidents Reporting system

3. Sentinel Event Reporting system

4. Root Cause Analysis and Risk Reduction Action Plan system

5. Limited Adverse Occurrence Screening (LAOS) system for hospitals

These initiatives are co-ordinated by the Quality and Care Continuity Branch,Effectiveness Unit (Incorporating Safety) in the Department of Human Services.

Improving Patient Safety in Victorian Hospitals 2000

This report, done by a team from Monash University, recommended acomprehensive approach to Clinical Risk Management (CRM).




57

As is illustrated below, the report’s recommendations about reporting systemshave been implemented.

Source: Improving Patient Safety in Victorian Hospitals, p. xi




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Victorian Quality Council

The Victorian Quality Council held its first meeting in October 2001. Its terms ofreference are reproduced below:

• Advise the Minister for Health and the Department of Human Services on the actionsthat should be taken to improve safety and quality of care in Victoria.

• Develop a three-year strategy to improve the quality of Victoria’s health services, for presentation to the Minister for Health by 30 June 2002.

• Collaborate with stakeholders and other quality related bodies such as ConsultativeCouncils, Department of Human Services Advisory Committees, and Health ServiceQuality Committees, in fostering quality improvement in Victoria’s health services.

• Advise on the most effective ways to involve consumers in health care provision andthe improvement of health care safety and quality.

• Analyse information about systemic safety and quality issues presented to theCouncil and provide advice on strategies for system improvement.

• Review the effectiveness of actions taken to respond to quality issues identified by

expert bodies and Health Service Quality Committees and recommend best practiceapproaches for dissemination.

• Work with the Australian Council for Safety and Quality in Healthcare to develop andimplement a coherent national strategy for improved safety and quality in health carethat meets the needs of Victorians.

• Provide advice on matters relevant to the quality of health services in Victoria asrequested from time to time by the Minister for Health, or by stakeholders.

xl

Similar to the New South Wales Quality Council, Victoria’s council has apredominantly medical membership.

According to the Clinical Risk Management Strategy , the Victorian QualityCouncil will receive recommendations from regional Consultative Councils. TheVictorian Quality Council’s endorsement of recommendations will be requiredprior to statewide system changes being made.xli The Council has not yetproduced any reports.

Clinical Incident Reporting

In addition to its Sentinel Event Reporting system, Victoria is also introducing aClinical Incident Reporting system:

Metropolitan health services and large regional hospitals are expected to implement anincident reporting system to receive reports of adverse events, potential adverse eventsand near misses by January 2002. An appropriate method of analysing information and

providing feedback to hospital staff should be part of these systems. All hospitals shouldactively encourage hospital staff to participate.

Metropolitan health services and large regional hospitals will be required to analyseadverse events, potential adverse events and near misses reported through incidentreporting systems. Strategies implemented aimed at reducing the number of adverse




59

events, potential adverse events and near misses are to be reported in their AnnualQuality of Care Report 2002.

Rural hospitals are required to …report in their first Annual Quality of Care Report, due inSeptember 2002. xlii

Four Victorian hospital networks also use the Australian Incident MonitoringSystem.

Statewide Sentinel Event Reporting

In addition to the Clinical Events Reporting system, Victoria is also introducingstatewide Sentinel Event Reporting . Sentinel events are defined as "relativelyinfrequent, clear-cut events that will occur independently of a patient's condition;commonly reflect hospital system and processed deficiency; and result inunnecessary outcomes for patients."xliii Part of the Sentinel Event Reporting Formis reproduced below to illustrate the system’s scope.




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All hospitals are required to report Sentinel Events to the Department of HumanServices within five days of occurrence.

Root Cause Analysis and Risk Reduction Action Plan

Within 45 working days of notifying the Department of Human Services of aSentinel Event, the hospital must submit a Root Cause Analysis on the formspecified by the Department. The form being used is a modified version of theJoint Commission on Accreditation of Healthcare Organizations form.

According to the Strategy ,

The product of a RCA is a Risk Reduction Action Plan that identifies strategies theorganization intends to implement, to reduce the risk of similar Sentinel Events occurringin the future. The RRAP should address responsibility for implementation of each ActionItem identified, pilot testing as appropriate, timelines, book or journal references

considered in the development of the Action Items, and strategies for measuring theeffectiveness of the Action Items. xliv

Limited Adverse Occurrence Screening (LAOS)

Victoria is also introducing, initially in Melbourne and its suburbs [calledMetropolitan Health] and large regional hospitals, followed by rural hospitals, achart review system called Limited Adverse Occurrence Screening . It isdescribed below:

LAOS was developed at the Wimmera Base Hospital in Horsham Victoria. Briefly,histories are extracted based on the presence of one or more of eight screening criteria,and then reviewed by clinicians for the presence of an adverse event. An adverse event

is defined as ‘an untoward patient event, which under optimal conditions is not aconsequence of the patient’s disease or treatment.’ The adverse event is then classifiedaccording to the certainty with which an adverse event has occurred, severity and

preventability. Adverse events are analysed, and recommendations aimed at preventingthese events from recurring are made and implemented.

LAOS is an effective way of identifying local system problems in clinical care, and hasbeen shown to be an effective mechanism for engaging physicians in the process ofclinical risk management (CRM). As its name suggests, it does not aim to identify alladverse events, and as such it limits the number of adverse events detected. Despite thelimitations in being able to produce quantitative data about adverse events, there isevidence of a decline in adverse events found when using these criteria.

xlv

The Clinical Risk Management Strategy sets out the criteria for inclusion in theLAOS system. These are:

• Death

• Unplanned return to operating suite within 7 days

• Transfer from general ward to intensive care




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• Readmission within 28 days of discharge

• Cardiac/respiratory arrest

• Transfer to a larger acute care facility

• Length of stay > 21 days

• Booked for theatre and cancelled xlvi

The implementation of the Strategy also includes a new Annual Quality of CareReport by each hospital. The Report is expected to include the followinginformation from LAOS:

• Details of the screening criteria implemented

• The number of inpatient medical records screened and reviewed

• Hospital process and system modifications made in response to adverse eventsdetected; and

• Evidence of measurable improvements in the processes and outcomes of patient carefollowing actions taken in response to adverse events

xlvii

The Strategy states that, “Current successful [LAOS] programs have a full timestaff member dedicated to the program”, and “…the involvement of respectedphysicians and nursing staff with a proportion of their paid work hours dedicatedto the program”.

Quality and Care Continuity Branch

The introduction of these new systems into Victorian hospitals is being supportedby the Quality Framework Business Rules 2001/2002 issued by the Branch.

Queensland

With a population of 3.6 million, Queensland is Australia's third-largest state. It isundertaking the following patient safety initiatives:

• Strategic Plan for Quality: Quality Improvement and EnhancementProgram: 1999 – 2004

• Queensland Health Council on Safety and Quality in Health Care

• Clinical and Non-clinical Risk Management Program




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Strategic Plan for Quality

The Strategic Plan for Quality: Quality Improvement and Enhancement Program:1999 – 2004 xlviii (the “Plan”) was developed in consultation with health service

providers and consumers.

The plan has six objectives:

1. Implementing improved systems to manage the quality of services and toreport on the performance of services in Queensland Health.

2. Encouraging members of the community to take active responsibility fortheir health and well-being by being informed and involving them in healthservice decision-making

3. Developing a culture of quality through continuous education of healthservice providers to ensure health services are safe, appropriate,effective, efficient, and accessible

4. Improving the coordination of health services and programs andcollaboration between health service providers and with other governmentand non-government sectors

5. Developing client/patient-centred information systems to facilitate thedelivery and evaluation of health services

6. Providing evidence based health services which are outcome focused andencourage innovative practice

Clinical and Non-Clinical Risk Management Program

The plan has 22 program areas "whose major foci include incident monitoring,risk management, reduction in variation in service delivery, education andtraining of staff, particularly clinicians, and the use of an evidence-basedapproach in the delivery of health services." xlix

Although many of the 22 program areas will undoubtedly contribute to patientsafety, two are directly relevant. The first one is Risk Management. This is todevelop “a risk management framework for clinical and non-clinical areasthroughout the organization" by June 2003. By that time the expecteddeliverables are:

• Risk Management Strategy• Risk Registry• Risk Treatment and Financing Strategy




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• Model for system-wide monitoring and review

The Risk Management program is also to develop an Incident Monitoring systemby June 2003. The Plan does not set out strategies or deliverables.

The second program directly related to patient safety is Patient Complaints andSurveys. By June 2003 this program is expected to deliver the following:

• Corporate policy and guidelines for collection and use of datamanagement and reporting

• Educational resources• Database

Queensland Health Council on Safety and Quality in Health Care

The Council was established in March 1999 to oversee the quality agenda. Its

terms of references are:

1. To ensure that health service development and planning withinQueensland Health incorporate risk management and quality improvementapproaches

2. To endorse an operational plan to guide the implementation of clinical riskmanagement and quality improvement strategies

3. To align resources, skills and expertise with the delivery of the strategies

4. To monitor the implementation of the operational plan

5. To promote a corporate approach to risk management and qualityimprovement strategies across Queensland Health's Zonal HealthServices, Units and Branches

6. To critically appraise and incorporate where appropriate, international andnational innovations in health service development, particularly in theareas of risk management and quality improvement

The Council has been given the authority to redirect resources among the 22

program areas based on performance and outcomes.

The Queensland Council has five physicians and six civil servants as members. All the physician members appear to be civil servants as well.




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Western Australia

The State of Western Australia has a population of 1.9 million. Western Australiahas taken the following initiatives:

• Strategic Quality Plan: Western Australia 1998/9 - 2002/3• Risk Management Initiative• Interim Quality Council

• Risk Register

Strategic Quality Plan

Similar to other state initiatives described above, Western Australia's initiativesare embedded in an overall quality improvement plan.

Interim Quality Council

The Strategic Quality Plan called for the establishment of a Western AustraliaHealth Services Quality Council. The purpose was to “provide overall guidance ata macro level. The implementation of the Strategic Quality Plan will beinfluenced by this Council. The Council will oversee a system-wide perspectiveon quality and will use the Plan as a guide for overall direction for the future".

An Interim Quality Council has been established but no information is availableon it at this time.

Risk Management Initiative

Western Australia intends to develop and implement an integrated riskmanagement system. The plan has four objectives:

• Develop a seamless approach to corporate and clinical governance for risk management

• Develop the capacity to learn from near misses and failures

• Develop and implement integrated risk management standards for the government healthindustry

• Ensure that management and employees are accountable for risk management

• Ensure that risk management is an integral part of the organisational culture. l




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The largest health care provider organization in the state is the MetropolitanHealth Services (MHS). It operates 12 hospitals and other facilities in the greaterPerth area. In its Annual Report 2000/2001 the MHS reports that it hasimplemented a Computerized Incident Management System. According to theReport,

It is expected that this system will enable efficient aggregation and analysis of data toidentify baseline incident rates, trends and patterns of incidents and contributing factors.It will also promote the development and evaluation of initiatives to prevent and reducethe number and severity of clinical incidents. The system will be introduced to allMetropolitan and rural hospitals and Western Australia during the second half of 2001.

li

MHS has a Performance Evaluation Unit that analyzes risk management data:

De-identified complaints and medical legal claims are trended and reported to the MHSand to the hospitals and health services on a quarterly basis in order that areas ofconcern may be identified and remedial action taken. A new method of categorizingcomplaints has been developed in order to maximize the usefulness of the information.

Medico-legal claims have similarly been placed under much closer clinical scrutiny toinform administrators and clinicians of the principal issues that give rise to legal actionand which adversely affect patient care. lii

MHS also reported that it had received $300,000 funding from the Interim QualityCouncil for three projects, including the Monitoring of Adverse Events: a publichealth approach.

Australian Capital Territory (Canberra)

The Australian Capital Territory (ACT) has a population 320,000. It has taken thefollowing patient safety initiatives:

• ACT Health Care Quality and Safety Forum

• Quality First: a commitment to quality and safety in ACT health services• Action Plan to implement

o Territory-wide adverse event incident monitoring systemo legislative requirement for all health facilities to participate in quality

improvemento territory-wide Death Review Program

Patient Safety: An Overview and A Patient Safety Action Plan for the ACT

ACT’s initiatives were preceded by these two reports commissioned by the Australian Capital Territory Government. The Overview report summarized theassumptions about patient safety:

• There are human and financial costs which result from unsafe practices and poor qualityservice and those costs are often unavoidable




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• there is a strong correlation between safety and quality - diminished standards of safetyreflect poor quality service

• safety and quality are shared responsibilities - all stakeholders, i.e. purchasers, providers(at all levels), funders, governing bodies and consumers have a role in ensuring thesafety and quality of health care services; and

•

error is an inevitable part of the human condition - systems need to be designed torecognize this and not to be based upon unrealistic expectations of perfectionliii

These reports were a blueprint for the initiatives described below.

ACT Health Care Quality and Safety Forum

This Forum was established to advise the Minister of Health on theimplementation of the strategic plan and action plan outlined below. The Forumhas representation from hospitals, community care agencies, the consumersassociation, physicians, the Department of Health, the Complaints

Commissioner, and consumers.

The terms of reference of the Forum include:• providing advice on strategies and priorities• identifying emerging needs and issues• identifying barriers to the implementation of evidence based health care• recommending systemic approaches on the measurement and

improvement of patient safety using agreed to quality of care indicators• providing advice on priorities for funding. liv

Quality First: a commitment to quality and safety in ACT health services

This document was published in May 2001 and meets ACT’s requirements underthe Australian Health Care Agreement. It also responds to an earlier PatientSafety Action Plan commissioned by the territorial government. A survey doneas part of the earlier Plan found the following in ACT health care facilities:

• Cultural and practical problems dealing with mistakes and system basederrors;

• very little measurement of outcomes across the system and few feedbackloops to judge of actions were improving quality and safety;

• little involvement of consumers at the decision-making end of health care

planning and policy setting; and• a lack of systems in place to collect and analyzed the causes of adverse

events and to implement systematic prevention strategies

On patient safety Quality First states:




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Goal: Potential risks to consumers are avoided and inadvertent harm minimized in thecare delivery process.

Achieving better patient safety requires recognition within the health system that:

• Safety is the responsibility of all stakeholder;

•

error is an inevitable part of the human condition; and• there are human and financial costs which result from unsafe practices

Action Plan

Within Quality First there is an action plan related to the patient safety goalquoted above:

Objective: the development and implementation of mechanisms which are used to promote safety and continuous improvement

Action 1: Implement an ACT Health and Community Care portfolio wide adverse event

incident monitoring system/program.

Key focus areas for patient safety:1. Examine the ability to improve the quality use of medicines in hospitals.2. Review the haemovigilance surveillance information systems.3. Examine the approach of acute care services infection control procedures.4. Safety management system in the disability services.

Action 2 : Review legislation to:

• Require all health facilities to participate in quality improvement

• Provide statutory protection

• Ensure confidentiality of specified quality improvement activities

Action 3: Establish an ACT-wide Death Review Program which produces annualdeidentified public reports on trends, recommendations for action and

progress from recommendations from the previous year




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ERROR REPORTING SYSTEMS AND DATA ANALYSIS

This section consolidates information on Australian error reporting and dataanalysis described throughout this report. In some cases, additional detail is

available in the states section above. In summary, AIMS is an established,voluntary, anonymous system, with reports going to the Australian Patient SafetyFoundation. The State/Territorial reporting systems are new, mandatory, with theinformation going to the State/Territorial health departments. It is not alwaysclear what the relationship is going to be between the AIMS system and the newState/Territorial systems. There is also the issue of whether individual case oraggregate information is reported to government.

Australian Incident Monitoring System (AIMS)

AIMS was initiated in 1988 by the Australian Patient Safety Foundation as a

voluntary, anonymous, national anaesthesia incident reporting system. In 1993 AIMS was expanded to include other specialty areas. In 1994 the system waschanged to an incident monitoring model usable on an institutional basis ratherthan merely a specialty basis. The Commonwealth Government providedfunding for this change so that the results could be used by the ProfessionalIndemnity Review. Today the system is in widespread use:

It is currently in use in all South Australian public hospitals, in four networks in Victoria,and the Northern Territory; plans are underway for its introduction to all of the AustralianCapital Territory and Western Australia and to parts of New South Wales, Tasmania andQueensland. It is being used or has been trialed, by 12 medical specialties. The new,simpler, more comprehensive version, with the option of reporting electronically via the

Web AIMS+, is currently being trialed and introduced. lv

AIMS+ is a four-page form that collects information about what happened, whatthe contributing factors were, what treatments or investigations are ordered, whatfactors minimized the adverse outcome, and what could have been done toprevent the incident. The first part of the form is filled out by health careproviders and the second part by an institution's management. The managementpart of the form collects information about the incidence outcome. The data onthe form is coded locally using a “Generic Occurrence Classification” systemdeveloped by APSF.

The AIMS database had almost 26,000 incident reports in its database at April2001. The table below reports the types of events.




69




70

NSW Performance Indicators

Area Health Services are being required to provide regular reports to the Qualityof Health Care Unit in the Department of Health about the quality of health care

they are providing. One set of indicators deals with safety. However, this doesnot appear to be an adverse incident reporting system per se. AIMS is not beingused uniformly across New South Wales. Thus, this appears to believe asignificant gap in Australian incident reporting because New South Wales is thelargest state.

Victoria Clinical Incident Reporting

As noted above, Victoria’s hospitals were to have a clinical incident reportingsystem in place by January 2002. Several Victorian hospitals were already using

AIMS. Only aggregate information is reported to the Department of Human

Services.

Victoria Sentinel Event Reporting and Root Cause Analysis

In addition to the Clinical Events Reporting system, Victoria is also introducingstatewide Sentinel Event Reporting . Sentinel events are defined as "relativelyinfrequent, clear-cut events that will occur independently of a patient's condition;commonly reflect hospital system and processed deficiency; and result inunnecessary outcomes for patients”. The reports are sent to the VictoriaDepartment of Human Services.

Queensland Incident Monitoring

The Queensland Risk Management program plans to develop an IncidentMonitoring system by June 2003.

Western Australia Computerized Incident Management System

The largest health care provider organization in the state is the MetropolitanHealth Services (MHS). It operates 12 hospitals and other facilities in the greaterPerth area. In its Annual Report 2000/2001 the MHS reports that it hasimplemented a Computerized Incident Management System.

ACT Adverse Event Incident Monitoring System

As part of its Action Plan, the Australian Capital Territory plans to implement astatewide adverse event incident monitoring system/program.




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Summary Table: Reporting SystemsState/Territory AIMS State Incident

SystemState SentinelEvent System

New South Wales PartialVictoria Partial Yes YesQueensland Partial Planned

Western Australia All PlannedSouth Australia AllTasmania Partial

Australian Capital Planned PlannedNorthern Territory All

Data Reporting and Analysis

Safety in Numbers: A Technical Options Paper for a National Approach tothe Use of Data for Safer Health Care

This Safety and Quality Council paper states:

Most existing data collections have not been designed to collect data about incidents andadverse events in ways that are useful for improving safety and very few give anyinformation about factors that contribute to the occurrence of these events. There is nosingle source of statistics that provides a reliable measure of the frequency or nature ofadverse events. Nor is there a repository or regular reporting system for these data in

Australia or other developed countries.lvi

The Council proposed three targets:

Target 1

By January 2004, all health care facilities will have incident monitoring systems in placewhich meet agreed national specifications and are capable of contributing nationallyconsistent data for system improvement

Target 2

By 1 July 2003, all health care services and States and Territories will have in place processes for the review of patient deaths which meet agreed national specifications,with particular focus on:

1. identifying and reviewing patient deaths which may be attributable to anadverse event

2. promoting appropriate referral of deaths to coroners; and

3. improving national information on causes of death

Target 3

By January 2004, all health care services and States and territories will have in place processes which meet agreed national specifications for action on adverse events whichlead to serious patient harm

lvii




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PUBLIC AND MEDIA OPINION

Australian Patient Safety Survey 2001

The Commonwealth Department of Health and Aged Care commissioned this

public opinion survey of 1501 Australians. The telephone questions asked weresimilar to ones used by the National Patient Safety Foundation in a 1997 survey."This survey represents the self-reported experiences of the general populationusing lay judgments of risk and what constitutes an adverse event".

The survey found a 6.5% incidence of self-reported adverse events. The surveyalso asked whether patient safety has improved, stayed the same or becomeworse. The chart below reports the responses by age group.

Source: Richard B. Clark, Australian Patient Safety Survey . Commonwealth Department of Healthand Aged Care, August 2001, p. 85

The survey author notes that the 45-54 age group is most likely to believe thatpatient safety is becoming worse.

Patient Safety Trend by Age Group




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Medical Error Action Group

This is a public interest organization that claims to have 11,000 members. lviii Ithas submitted a brief to the Commonwealth government proposing that a systemsimilar to that used by the Veterans Affairs Medical Centre in Lexington,

Kentucky be adopted in Australia. This system encourages the admission ofmedical mistakes and volunteers compensation to victims.

Former President, Australian Medical Association

In a commentary broadcast on the Australian Broadcasting Company nationalradio service on Jan. 28, 2002 Dr. Lionel Wilson, former President of the

Australian Medical Association stated:

There's been a lot of talk about safety and quality in Australian hospitals for the past 30years and a good deal of related activity. However, I believe that very little that is trulyeffective is being achieved.

A quick glance at the daily media only serves to confirm this, the latest being three casesof deaths associated with errors in blood transfusions in three of our hospitals. The rateof so-called "adverse events" producing 18,000 avoidable deaths annually has been welldocumented. Long experience in this area convinces me that governments, hospitalsand doctors simply have not addressed the fundamentals needed to provide a solution tothe problem… the establishment of committees at National or State level, no matter how

prestigious the memberships, will never enable Governments to guarantee quality of carein hospitals. Improving quality can only occur at the workface. Government's role is tointroduce "drivers", that is incentives that target hospital Boards and Management.

The Australian Commentary

The Australian is a prestigious national newspaper. In January 2000 it ran alengthy commentary by Mike Steketee, the papers national affairs editor, entitled,"Nation dawdles over hospital deaths". This ran just after the Institute ofMedicine study was published in the United States. The piece is quite critical ofthe Australian initiatives:

This [U.S. and British] sense of urgency about a rapidly emerging issue is notably absentin Australia…. Federal Health Minister Michael Wooldridge has just appointed BruceBarraclough of the College of Surgeons to head a 20 member Australian Council forSafety and Quality in Health Care. It is the first substantial measure the FederalGovernment has taken to tackle medical mistakes and it came five months after health

ministers agreed to the council. That, in turn, was four years after the report whichsuggested there was a serious problem. There have been some steps taken since thenby the NSW and Victorian governments but very few by other states and theCommonwealth, which provides half the budgets of public hospitals.

Those looking for dramatic initiatives from the new council are likely to be disappointed.Dr. Barraclough is a highly regarded surgeon and, according to one colleague, “has aview of the health system which is broader then your average college president". But heis far from a radical.




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Like Wooldridge, Barraclough discounts the actual figures on adverse events, whileacknowledging the issue must be addressed. He is a strong defender of the medical

profession, which means he should be able to win the cooperation of doctors in anyreforms. But doctors are part of the problem and they have resisted changes which theybelieve contain even the slightest hint of inhibiting their clinical freedom. The concern iswhether the changes will go far enough…

Having been among the first to look at this issue in 1995, Australia now shows every signof being left behind in its response.




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REGULATORY, LEGAL AND INSURANCE ISSUES

Qualified Privilege

Both the Commonwealth Government and State governments have "qualifiedprivilege schemes" to protect information used in quality assurance or practiceimprovement programs.

The Commonwealth scheme applies to quality assurance processes that takeplace in more than one state, or where a quality assurance activity involves amethodology that is new in Australia or has the potential to affect the quality ofhealth care on a national scale.

In the Commonwealth scheme, the quality assurance program must seek adeclaration from the Commonwealth Minister of Health that the program is

covered by the legislation. There is an application and review process todetermine eligibility.

To be eligible, the Minister must be satisfied that the declaration will:

• Encourage full participation in the [quality assurance] activity, or in the case of an activity previously undertaken, encourage participation to a greater extent than in the previousactivity; and

• encourage acceptance, implementation and monitoring of any recommendations whicharise from the activity. lix

Once designated, a quality assurance activity must keep confidential all theinformation that identifies individuals that became known solely as a result of thedeclared activity. The confidentiality requirement does not apply to aggregate,no-identifying information.

The State schemes apply to quality assurance bodies that operate in only onestate, and usually the Commonwealth scheme is not used in such State-specificprograms.

The chart below summarizes the various provisions of Commonwealth and Stateschemes.




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Source: Quality and Safety Council, The Public Interest in Health Care Qualified Privilege. August 2001, p,14

In a recent review of qualified privilege, the Safety and Quality Council proposedNational Principles to Underpin Qualified Privilege. These are:

• Qualified privilege schemes should seek to strike an appropriate balance betweenthe public interest in access to information, and the public interest in removing

barriers to participation by health care professionals in meaningful safety and qualityactivities

• Organizations and individuals that benefit from qualified privilege should have acorresponding duty of openness to publish or disclose not individually identifyinginformation obtained in the course of the safety and quality activity. Specificrequirements should be established to disclose to the public meaningful, notindividually identifying information about safety and quality activities

• Qualified privilege should provide specified protection against defamation and certainother forms of civil litigation to participants of effective safety and quality activities

• The sort of information that is accorded protection through qualified privilege shouldbe clearly specified for each qualified privilege scheme

•

An avenue should be available for referral to appropriate professional, administrativeand legal bodies where there is evidence that:

o a serious offence may have been committed; and

o there are serious and continued variations in performance from what wouldbe regarded as unacceptable standard of care




77

• Participants of protected activities and the broader community should be aware ofqualified privilege schemes and have a clear understanding of the scope of

protection provided by the legislation

• The application and monitoring of compliance with the legislation needs to beadministratively simple and transparent to both the public and the health careindustry.

lx

It would appear that all the Australian qualified privilege schemes are somewhatcompromised by the fact that Freedom of Information Legislation overrides all ofthem.lxi

Malpractice Insurance Issues

Review of Professional Indemnity Arrangements for Health CareProfessionals

This Review (“PIR”) occurred between 1991 and 1995 and was commissioned bythe Commonwealth Government. The concerns that prompted its establishmentwere:

• very few people who suffer adverse health care outcomes are actually compensated andfor these people the common-law system is extremely costly and involves unreasonabledelays;

• operation of the current fault-based compensation systems sometimes conflicts withbroader public health policies such as the desirability of immunization. For example, byacting as deterrent to manufacturers of therapeutic goods and doctors where their activityis perceived to entail a high risk of being sued;

• the current indemnity, legal and compensation arrangements are ineffective in the prevention of adverse patient outcomes;

• the existing indemnity arrangements for health care professionals may be inadequate;

• the levels of subscriptions for indemnity for some health care professionals have beenrapidly increasing; and

• the law with regard to the vicarious liability of employers is inconsistent among the statesand in some respects inadequate. lxii

In 1991 the PIR commissioned a feasibility study on reproducing the HarvardMedical Practice Study in Australia. This was done in 1993 and became known

as the Quality in Australian Health Care Study . The results were released by theCommonwealth Minister for Human Services and Health in June 1995:

Extrapolation of the results of the Quality in Australian Health Care Study with respect toadverse events in the Australian hospital population in 1992 offers striking figures. Forexample, it indicates around 30,000 people suffered a permanent disability of some kindand between 10,000 - 14,000 died because of preventable adverse events. The totalnumber of adverse events which were preventable is likely to be around 230,000.

lxiii




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In response to the study results, the Australian Health Ministers Conference inJune 1995 agreed to establish the Task Force on Quality in Australian HealthCare. The Task Force is described above in the National Initiatives section.

In its final report in November 1995, the PIR stated:

In brief, the PIR’s research concludes that there are very many adverse patient outcomeswhich arise out of health care in the Australian health care system - probablyconsiderably in excess of 400,000, with around 230,000 being preventable with currentknowledge according to the results of the PIR’s Quality in Australian Health Care Study.While many of them involve only minor disabilities, 30% resulted in a disability which waslikely to prevent the person returning to work or normal activities for between 1-12months, and 20% resulted in some degree of permanent disability or death. lxiv

The PIR made 168 recommendations, the first of which was:

The PIR recommends that the Task Force on Quality in Australian Health Care gives

priority to:

(a) identifying those adverse events which are the most frequent and preventableand cause the greatest degree of disability or death (priority adverse events); and

(b) developing strategies to prevent the priority adverse event.lxv

Victoria Professional Indemnity Review 1995-1997

This review by a committee of the Victoria Parliament was largely consumed withtort reform and removing disincentives from rural practice. lxvi It did note therelationship between the incidence of adverse events and the need to have a

compensation system that is fair and efficient.

Bankruptcies and Withdrawal from Market of Malpractice Insurers

At the time of writing (June 2002), Australia was dealing with a crisis due to thecollapse of the country's largest malpractice insurer, United Medical Protection.UMP is akin to the Canadian Medical Protective Association. UMP was formed in1997 when the British Medical Protection Society and Medical Defence Union leftthe Australian market. UMP represented more than 40,000 of Australia's 55,000doctors.

This had been preceded by the bankruptcy of HIH, Australia's largest insurancegroup. It had covered some physicians. The situation has also recently beenexacerbated by the withdrawal of the U.S. St. Paul group from all malpracticeinsurance markets, including Australia.

In 2000, UMP paid out an unprecedented $95.8 million to 1,035 claimants. Onepayout was $9.3 million, with eight additional cases receiving payouts of morethan $1 million. In that year, it had more than 20,000 incidents on its books and




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more than 4,000 unsettled claims. lxvii In December 2000, UMP called on all itsmembers to pay an additional year's premium to boost its reserves. It alsoimposed an 8% premium hike.

UMP stopped doing business on April 28, 2002. This forced the Commonwealth

government to guarantee coverage to physicians until June 30, 2002.

Commercial and insurers have told the government that they are prepared toenter the medical indemnity market on July 1, 2002 provided the followingconditions are met:

• Cover be provided on a "claims made" basis for incidents occurring after the entry ofcommercial insurers into the market;

• cover be provided up to a limit, as is the case with most other forms of insurance; and

• State and Territories undertake substantial tort law reform to place future claims on amore sustainable basis.

lxviii

On April 23, 2002 a Ministerial Meeting on Medical Indemnity was held inCanberra. It included all Health Ministers and the Commonwealth Minister forRevenue and Assistant Treasurer. The Commonwealth agreed to introducelegislation to make tax changes to encourage structured settlements and todevelop broadly based tort law reform measures. The Ministers also noted therelationship to patient safety:

Health Ministers therefore reaffirmed their commitment to joint Commonwealth, State andTerritory action through the Australian Council for Safety and Quality in Health Care,aimed at reducing adverse medical outcomes; encouraging doctors to fully inform

patients of any risks; and more open disclosure when things go wrong.

Ministers noted that the Council has been allocated $451,000 to its open disclosure project, which has particular relevance to medical indemnity and claims arising frommedical events.

They agreed that:

• The Council will continue to develop a list of catastrophic adverse events forspecific action and make recommendations to Health Ministers by July 2002;and

• Health Ministers will develop nationally consistent legislative proposals to ensurethat a doctor’s expression of regret is not construed as an admission of liability.lxix

The Ministers also agreed to the establishment of a national database for allmedical negligence claims. It will include data from the Health InsuranceCommission compensation recovery database, and efforts will be made toinclude data from Medical Defence Organizations. It is hoped that the databasewill be ready by July 2002. lxx




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In June 2002 the Commonwealth and state governments jointly appointed apanel chaired by a Supreme Court judge to investigate various aspects ofnegligence law and report back to the government in stages. lxxi

Role of Professional Governing Bodies

Professions are governed at the state level. To date, Australian professionalgoverning bodies do not appear to have played any significant role in thedevelopment of patient safety initiatives. For example, they appear not to berepresented on the State Quality Councils, the Safety and Quality Council, the

Australian Patient Safety Foundation, or the National Institute of Clinical Studies.No governing body publications or statements about patient safety or qualitywere found.

The medical licensing bodies’ peer review processes are reactive – requiring acomplaint – rather than proactive. However, this may change as a result of anitem in the Safety and Quality Council’s Action Plan:

New South Wales and Queensland to lead national work to develop national standardsfor robust models of credentialing and clinical privileging in health care facilitiesencompassing consideration of peer and performance review processes and effectiveapproaches to organizational accountability for safety and quality improvement

lxxii

Complaints Commissions

In Australia, there are two bodies that handle complaints against health

practitioners – the professional governing bodies, and State Health ComplaintsCommissions. The latter are independent statutory bodies. Complaints may alsobe registered against hospitals and any other public or private facility where careis provided, as well as unregulated providers.

The commission has independent investigatory power. In New South Wales, forexample, the Health Complaints Commission must investigate a complaint when:

• it concerns an important public health and safety issue

• it raises significant questions about the care and treatment provided by health care practitioner, such as a doctor, dentist, or nurse

• disciplinary action against a health care practitioner may be required; or

• a health registration authority, such as a Medical Board, believes that a complaint shouldbe investigated

lxxiii

After the investigation, the Commission may:

• prosecute the complaint before a disciplinary body;




81

• intervene in any proceeding that may be taken before a disciplinary body;

• refer the complaint to the appropriate registration authority (if any) with arecommendation as to any disciplinary action the Commission considers appropriate;

• make adverse comments to the health care practitioner regarding the complaint;

• discontinue dealing with the complaint; or

• refer the matter to the Director of Public Prosecutions. lxxiv

GAPS

Reporting

Although Australia would appear to have the world’s most advanced errorreporting system (AIMS) it is not universally used across the country. TheVictorian Sentinel Event Reporting Form is used only in that state.

There are preliminary initiatives to apply AIMS to the entire country.

Primary Care

Australia’s patient safety efforts seem to be focused largely on hospitals. Thereappear to be no initiatives designed to reach primary care settings.

Private Hospitals Excluded

Most patient safety initiatives are government programs for government-funded

medicare services. The privately-funded hospitals and services in most casesseem to be excluded.




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FUTURE PLANS

Australian Health System Safety Surveillance Unit

It has been agreed that an Australian Health System Safety Surveillance Unit willbe established by the Australian Patient Safety Foundation as a CollaboratingUnit of the Australian Institute of Health and Welfare to coordinate the ongoingcollation and analysis of information at a national level.lxxv (This Institute is akinto the Canadian Institute for Health Information.)

National Database for Medical Negligence Claims

Health Ministers agreed in the spring of 2002 to the establishment of a nationaldatabase for all medical negligence claims. It will include data from the HealthInsurance Commission compensation recovery database, and efforts will bemade to include data from Medical Defence Organizations. It is hoped that thedatabase will be ready by July 2002.

Safety and Quality Council Medication Safety Standards and Guidelines

In its 2001 Report to Health Ministers, the Safety and Quality Council identifiedmedication safety as a priority area and proposed a project to “reduce medicationerror through system and process redesign”. lxxvi

Safety and Quality Council Review of Regulatory Barriers to Safety

The Council is considering a project to scope existing legislation and regulationto identify barriers to and opportunities to improve safety. lxxvii




83

Chronology of Australian Patient Safety Initiatives

1989 Australian Patient Safety Foundation (APSF) established1991-1995 National Review of Professional Indemnity Arrangements for

Health Care Professionals

1995 Task Force on Quality in Australian Health Care established1995 Quality in Australian Health Care Study released1995 State of Victoria Professional Indemnity Review1996 National Expert Advisory Group on Safety and Quality in

Australian Health Care (NEAG) established by AustralianHealth Ministers

1996 APSF establishes Australian Incident Monitoring System(AIMS)

1998-2003 Australian Health Care Agreements allocate $660 million ofCommonwealth funding to hospitals quality and safetyinitiatives

1999 NEAG’s Final Report, Implementing Safety and QualityEnhancement in Health Care released

2000 Improving Patient Safety in Victorian Hospitals published

2000-2001 States publish strategic plans and form quality councils tocomply with AHCA

2001 National Council for Safety and Quality established; $22mbudget over 4 years

2001 Australian Patient Safety Survey published




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UNITED KINGDOM

BACKGROUND

System of Government

In 1998 the U.K. introduced devolution of certain authority to Scotland andWales, thus transferring political decision-making in some defined areas from theU.K. Parliament at Westminster to the Scottish Parliament and the National

Assembly for Wales. Some areas are reserved for Westminster, including theregulation of the professions. Other areas, such as “health and personal socialservices”, have been devolved to Scotland and Wales. Scottish Ministersexercise executive authority over the National Health Service (NHS) in Scotland,for example. In Wales, the National Assembly for Wales exercises bothlegislative and executive authority, including over the Welsh NHS. Westminstercontinues to govern England. Scotland and Wales can co-operateadministratively with England through “concordat” agreements. lxxviii

Thus, there are three jurisdictions in the U.K. responsible for the delivery ofhealth care. In this paper, all initiatives apply to England, most have beenadopted by Wales, and some by Scotland.

Health Care System

The U.K. Department of Health has overall responsibility for health care in

England. The National Health Service (NHS) is the publically-funded health caredelivery vehicle. The regional structure of the NHS is in the midst of changingfrom 95 health authorities to 28 larger “strategic” health authorities.

Under the 28 new strategic authorities there will be primary care trusts (PCTs)and NHS trusts. The 303 PCTs “are the cornerstone of the NHS, responsible forthe planning and securing of health services…. Eventually they will control 75%of the NHS budget”. NHS trusts are found in large towns and cities and arehospital-based organizations, but can also provide community services.lxxix

The English NHS structure is illustrated below:




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Source: NHS Website

The U.K. spends 6.7% of GDP on health. lxxx The government plans to increaseNHS spending from £50B to £69B by 2005, placing the U.K. at the European

Union average for health care expenditure.lxxxi

The U.K. has a population of 59.1million.




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REPORTS AND INQUIRIES

In the last four years there have been eleven significant reports published in theU.K. that deal directly with patient safety matters. These reports have provided

significant impetus for the development of patient safety initiatives. Theseinitiatives are described below, but first we review the reports. They arepresented in chronological order to show the development of patient safetyissues. Seven of these reports have been published in the last 18 months. Themilestone reports were An Organisation with a Memory in May 2000 and TheBristol Royal Infirmary Inquiry Final Report in July 2001.

A First Class Service: Quality in the new NHS – December 1997

This paper, published by the then new Labour government, addressed issues ofaccessibility, rate variability and quality. Although the paper did not deal explicitlywith patient safety issues, many of the initiatives announced in the paper havecome to have a direct bearing on patient safety. Among the initiativesannounced by this paper were:

• National Service Frameworks• National Institute for Clinical Excellence• Clinical Governance• Commission for Health Improvement

These initiatives are described in the "National Initiatives" section below.

Supporting doctors, protecting patients - 1999

A consultation paper on preventing, recognizing and dealing with poor performance of doctors in the NHS in England – November 1999

This 1999 NHS consultation paper was prompted by “a growing number of caseshitting the headlines which have shown that a small number of doctors areproviding poor or inadequate care…[which is damaging] public confidence in theability of the National Health Service to deal with problems quickly, effectivelyand fairly”. lxxxii The paper stated that, “The current procedures for detecting and

dealing with poor clinical performance are fragmented and inflexible”.lxxxiii

In thepaper, “The Government proposes the abolition of the existing disciplinaryprocedures and the establishment of a new integrated process involving NHSand professional bodies.” lxxxiv The proposed new procedures were:

• Doubts or concerns about clinical performance would lead to referral to an Assessmentand Support Centre




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• Misconduct of a personal nature such as theft, sexual or racial harassment or violence,would be dealt with under the local employer’s internal disciplinary procedures

• Failure to fulfil contractual commitments…would also be dealt with under the employer’sdisciplinary procedures or contractor mechanisms

• Serious clinical problems or mistakes would warrant immediate referral to the General

Medical Council, without taking the step of referral to an Assessment and SupportCentre.

The Assessment and Support Centres proposal was not implemented. Instead, aNational Clinical Assessment Authority was established; this is described later.The implementation strategy report is described later in this section.

An Organization with a Memory – May 2000

An Organization with a Memory is the report of the expert group on learning fromadverse events in the National Health Service, chaired by the Chief Medical

Officer. The expert group included physicians, professors of medicine, professorsof nursing, hospital administrators, risk management experts, psychologists, andofficials involved in adverse event investigations.

The terms of reference were:

To examine the extent to which the National Health Service and its constituentorganizations have the capability to learn from untoward incidents and service failures sothat similar occurrences are avoided in the future. To draw conclusions and makerecommendations.

lxxxv

Of all the U.K. reports, this is the most comprehensive and influential. It hasattracted significant international attention. Many of the initiatives outlined belowstem from recommendations made by the expert group.

The expert group defined the problem as follows:

Research suggests that an estimated 850,000 (range 300,000 to 1.4 million) adverseevents might occur each year in the NHS hospital sector, resulting in a £2 billion directcost in addition to hospital days alone; some adverse events might be inevitablecomplications of treatment but around half might be avoidable.

lxxxvi

The report also notes that:

• 400 people die or are seriously injured in adverse events involving medical devices

• nearly 10,000 people are reported to have experienced serious adverse reactions todrugs

• around 1,150 people who have been in recent contact with mental health servicescommit suicide

• nearly 28,000 written complaints are made about aspects of clinical treatment in hospitals




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• the NHS pays out around £400 million a year settlement of clinical negligence claims,and has a potential liability of around £2.4 billion for existing and expected claims

• hospital acquired infections -- around 15% of which may be avoidable -- are estimated tocost the NHS nearly £1 billion. lxxxvii

The report strongly advocates taking a systems approach to errors rather thanblaming humans:

Human error is commonly blamed for failures because it is often the most readilyidentifiable factor operating in the period just prior to an adverse event. Yet two importantfacts about human error are often overlooked. First, the best people can make the worstmistakes. Second, far from being random, errors fall into recurrent patterns. lxxxviii

The report develops the idea of a “safety culture” in organizations thattranscends any specific measures. The report notes, " Airlines operate globallywith similar equipment, training and licensing, but the risk to passengers amongdifferent carriers varies by a factor of 42. A significant part of this variation can

probably be attributed to differing ‘safety cultures’”. lxxxix

A safety culture requires an “informed culture". The report outlines four criticalsubcomponents of an informed culture:

• a reporting culture: creating an organizational climate in which people are prepared toreport their errors or near-misses. As part of this process data need to be properlyanalyzed and fed back to staff making reports to show what action is being taken;

• a just culture: not a total absence of blame, but an atmosphere of trust in which peopleare encouraged to provide safety-related information - at the same time being clear aboutwhere the line is drawn between acceptable and unacceptable behaviours.

• a flexible culture: which respects the skills and abilities of "frontline" staff and whichallows control to pass to task experts on the spot; and

• a learning culture: the willingness and confidence to draw the appropriate conclusionsfrom its safety information system, and the will to implement major reforms where theirneed is indicated. xc

The report and suggests the following steps to create an informed culture:

• Raise awareness of the costs of not taking risks seriously

• Focus on "near misses" as well as actual incidents

•

Ensure that concerns can be reported without fear• Avoid simplistic counting

• Develop effectively lead teams as mechanisms for culture change

• Use external input to stimulate learning. xci




89

Some of the report’s conclusions include:

• Awareness of the nature, causes and incidences of failures is a vital component of prevention - (“You can't know what you don't know")

• Analysis of failures needs to look at root causes, not just proximal events; human errors

cannot sensibly be considered in isolation of wider processes and systems

• Error reduction and error management systems can help to prevent or mitigate theeffects of individual failures

• Sound safety information systems are a precondition for systematic learning fromfailures. They need to take account of the fact that low-level incidents or "near misses"can provide a useful barometer of more serious risks, and can allow lessons to belearned before a major incident occurs

• Given appropriate approaches to analysis, it is possible to identify common themes orcharacteristics in failures which should be of use in helping to predict and prevent futureadverse events.

xcii

The report analyzed gaps in the National Health Service incident reportingsystems:

• There is no standardized, operational definition of "adverse event" which would be easilyunderstood by all NHS staff

• The coverage and sophistication of local incident reporting systems, and the priorityafforded to them by NHS Trusts, varies widely. Incident reporting in primary care islargely ignored

• Regional Offices of the NHS Executive are charged with establishing and maintainingsystems for reporting and monitoring incidents beyond the organizations immediatelyconcerned, but there are major differences in the approach taken in the eight parts of thecountry

• The regional incident reporting systems undoubtedly miss some serious incidents andtake hardly any account of less serious incidents or those which do not harm patients butmight have done

• There is no standardized approach to investigating serious incidents at any level. Mostinvolve internal enquiries, some involved in external enquiries but the way in which adecision is taken or how they are carried out is inconsistent

• Current systems do not facilitate learning across the NHS as a whole. xciii

The report notes that most of the evidence on adverse events relates to hospital-based care. However, the report also stresses "that this report and its

conclusions are nevertheless of equal relevance to primary care…. The case ofDr. Harold Shipman, the Lancashire General Practitioner convicted earlier thisyear of murdering 15 of his patients, is fortunately exceptional, yet it serves as apowerful illustration of the implications of the major deficit in the reporting ofserious adverse events at source ". xciv




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The report made 10 recommendations:

1. Introduce a mandatory reporting scheme for adverse health care events and specifiednear misses

2. Introduce a scheme for confidential reporting by staff of adverse events and near misses

3. Encourage a reporting and questioning culture in the NHS

4. Introduce a single overall system for analyzing and disseminating lessons from adversehealth care events and near misses

5. Make better use of existing sources of information on adverse events

6. Improve the quality and relevance of NHS adverse event investigations and inquiries

7. Undertake a program of basic research into adverse health care events in the NHS

8. Make full use of new NHS information systems to help staff access learning from adversehealth care events and near misses

9. Act to ensure that important lessons are implemented quickly and consistently

10. Identify and address specific categories of serious recurring adverse health care event xcv

Assuring the Quality of Medical Practice – January 2001

This NHS report is the implementation strategy for Supporting doctors, protecting patients. It inaugurated the National Clinical Assessment Authority,which is described in the next section. It also provides a comprehensive view ofthe safety and quality measures the NHS is putting in place, the details of whichcan also be found in the next section.

The report also outlines legislative reforms introduced in 2000 to enhance the

powers of the General Medical Council:

• A new power to impose interim suspension or conditions quickly, to stop a doctor whorepresents a danger to patients from practicing until his fitness to practice has beendemonstrated

• Placing a statutory duty on the GMC to notify employers and any other person or bodywho may need to be informed, of doctors whose fitness to practice is under consideration

The report also endorses the formation of a new Council of Health Regulators,designed to develop common approaches across professions on how to dealwith complaints against practitioners. It also notes, "Where concerns remain

about the individual self-regulatory bodies, [the Council’s] role could evolve".xcvi




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Building a safer NHS for patients: Implementing An Organization with aMemory – April 2001

The Government accepted all the recommendations made in An organizationwith a memory . xcvii The Government’s response was titled, Building a safer NHS

for patients. The key commitments made by the government were:• the establishment of a National Patient Safety Agency

• the commitment to establish a new national reporting system for adverseevents and near misses

• the setting of specific error reduction and elimination targets

• a strategy for patient safety research

These programs and initiatives are described below in the “National Initiatives”section.

Appraisal for consultants working in the NHS – April 2001

Consultants (specialists) working in the NHS are required to undergo an annualpeer appraisal. This document includes the forms that appraised and appraisersmust fill out. “The appraisal process will not of itself result in the generation ofsignificant amounts of new evidence or information, rather it will capture theinformation that already exists.” xcviii The details of the appraisal process are described in a following section.

Handling clinical negligence claims in England - May 2001

The National Audit Office undertook an audit of the National Health ServiceLitigation Service (NHSLS). The NHSLS covers many NHS trusts, includingdoctors working in trust hospitals. It currently handles 42% of claims. (Claimsagainst general practitioners are covered by medical protective associations orprivate insurers.) The audit found the following:

• The total annual charge to NHS for settling claims has risen sevenfoldsince 1995-96

• The rate of new claims per thousand finished consultant episodes rose by72% between 1990 and 1998

• In 1999-2000 the NHS received 10,000 new claims and cleared 9,600;there were an estimated 23,000 claims outstanding

• The estimated net present value of outstanding claims was £2.6 billion inMarch 2000

The report did not examine measures taken to prevent negligent incidents fromhappening. xcix




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A Commitment to Quality, a Quest for Excellence – June 2001

This was a joint statement of the medical profession, the Government, and theNational Health Service. The medical organizations signing were: the General

Medical Council, the Royal College of Surgeons of England, the Academy ofMedical Royal Colleges, the Joint Consultants Committee, and the SpecialistTraining Authority. The medical organizations endorsed the government's plansto promote high-quality health care, including the initiatives in patient safety.

On patient safety, the statement says:

Medicine is not a perfect science. Sometimes things go wrong. Even the best peoplecan make the worst mistakes. Our shared commitment is to work to minimize errors,reduce their impact when they do occur, to learn from mistakes and to makeimprovements in clinical quality a cornerstone of reform in the NHS. It is change in NHScultures and systems, as much as changing how staff work, that will unlock the

improvements patients want to see.c

Bristol Royal Infirmary Inquiry: Final Report – July 2001

In the forward to Assuring the Quality of Medical Practice, the Minister of Statefor Health, John Denham, stated that, "… the last few years have seen a seriesof high profile medical scandals". ci

Undoubtedly, one of the scandals happened at the Bristol Royal Infirmary'spaediatric cardiac surgical service. The Public Inquiry that investigated the

service concluded that, "In the period from 1991 to 1995 between 30 and 35more children under 1 died after open heart surgery in the Bristol Unit than mighthave been expected had the Unit been typical of other PCS units in England atthe time," ciiand that the mortality rate was "roughly double that elsewhere in fiveout of seven years". ciii

The Inquiry said of its findings:

It is an account of a time when there was no agreed means of assessing the quality ofcare. There were no standards for evaluating performance. There was confusionthroughout the NHS as to who was responsible for monitoring the quality of care. civ

One of the Inquiries "guiding principles" was that "Patients’ safety must be thefoundation of quality". cv

As part of its terms of reference, the Inquiry was also to make recommendationsthat could "help secure high-quality care across the NHS". At a system level, theInquiry stated the following:




93

Around 5% of the 8.5 million patients admitted to hospitals in England and Wales eachyear experience an adverse event which may be preventable with the exercise ofordinary standards of care. How many of these events led to death is not known but itmay be as high as 25,000 people a year. cvi

The Inquiry made 198 recommendations, 16 of which fell under the heading "The

safety of care":

We support and endorse the broad framework of recommendations advocated in thereport “An Organisation with a Memory” by the Chief Medical Officer’s expert group onlearning from adverse events in the NHS. The National Patient Safety Agency proposedas a consequence of that report should, like all other such bodies which contribute to theregulation of the safety and quality of healthcare, be independent of the NHA and the DoH.

Every effort should be made to create in the NHS an open and non-punitive environmentin which it is safe to report and admit sentinel events.

Major studies should, as a matter of priority, be carried out to investigate the extent andtype of sentinel events in the NHS to establish a baseline against which improvements canbe made and measured.

A national reporting system

There should be a single, unified, accessible system for reporting and analyzing sentinelevents, with clear protocols indicating the categories of information which must bereported to a national database.

The national database of sentinel events should be managed by the National PatientSafety Agency, so as to ensure that a high degree of confidence is placed in the systemby the public.

The National Patient Safety Agency, in the exercise of its function of surveillance ofsentinel events, should be required to inform all trusts of the need for immediate action, in

the light of occurrences reported to it. The Agency should also be required to publishregular reports on patterns of sentinel events and proposed remedial actions.

All sentinel events should be subject to a form of structured analysis in the trust wherethey occur, which takes into account not only the conduct of individuals, but also the widercontributing factors within the organization which may have given rise to the event.

Incentives to encourage the reporting of sentinel events

The reporting of sentinel events must be made as easy as possible, using all availablemeans of communication, (including a confidential telephone reporting line).

Members of staff in the NHS should receive immunity from disciplinary action by theemployer or by a professional body if they report a sentinel event to the trust or to the

national database within 48 hours, except where they themselves have committed acriminal offence.

Members of staff in the NHS who cover up or do not report a sentinel event may besubject to disciplinary action by their employer or by their professional body.

The opportunity should exist to report a sentinel event in confidence.




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There should be a stipulation in every healthcare professional’s contract that sentinelevents must be reported, that reporting can be confidential, and that reporting within aspecified time will not attract disciplinary action.

The process of reporting of sentinel events should be integrated into every trust’s internalcommunications, induction training and other staff training. Staff must know what isexpected of them, to whom to report and what systems are in place to enable them to

report.

Designing for safety

The proposed National Patient Safety Agency should, as a matter of urgency, bringtogether managers in the NHS, representatives of the pharmaceutical companies andmanufacturers of medical equipment, members of the health care professions and the

public, to seek to apply approaches based on engineering and design so as to reduce(and eliminate to the extent possible) the incidence of sentinel events.

cvii

The Report also make recommendations about the role of the Department ofHealth:

The Department of Health's roles in relation to the National Health Service must in futurebe made explicit. The Department should have two roles. It should be the headquartersof the NHS. It should also establish an independent framework of regulation which willassure the quality of the care provided in and funded by the NHS, and the competence ofhealth care professionals. cviii

The Report recommended the formation of two new bodies to oversee theregulation of health care: a Council for the Quality of Healthcare to bring togetherthose bodies which regulate healthcare standards and institutions; and a Councilfor the Regulation of Health care professionals to bring together bodiesregulating health care professions.

Doing Less Harm: Improving the safety and quality of care throughreporting, analyzing and learning from adverse incidents involving NHS

patients – August 2001

This is a Department of Health/National Patient Safety Agency consultationdocument that describes work in progress to design a national adverse patientincident reporting system. The proposed system is described below in the sectionon Error Reporting Systems and Data Analysis.

Learning from Bristol: The Department of Health's Response – January

2002

In the Government's response to the Bristol Inquiry, (also known as the KennedyReport) the Secretary of State for Health, Alan Milburn, noted that, "Bristol wasthe turning point in the history of the NHS. We are determined that some goodcan come from the tragedy that took place there". cix




95

The Response endorsed "the Kennedy Report’s arguments for separation of theDepartment of Health's role in management and regulation…". cx and acceptedthe recommendations that a Council for Quality of Health Care and Council forthe Regulation of Health Care professionals be established.

By the time the Bristol Inquiry Report had been published, the Government hadalready committed itself to numerous patient safety initiatives, as the summariesof the preceding reports illustrate. Nevertheless, the government's responseoutlined more new initiatives. These include:

• A National Knowledge Service to deliver high-quality information topatients and staff

• Patient Advice and Liaison Services to assist patients in managing andaccessing information

• a White Paper on clinical negligence• guidance on root cause analysis to help trusts analyze adverse events

• publication of clinical data on the performance of specialists and theirteams for use by both clinicians and patients

• NHS bodies directed to fund treatments recommended by NationalInstitute for Clinical Excellence effective January 2002, and NICEguidance no longer needing the approval of the Secretary of State forHealth before dissemination

• strengthening Commission for Health Improvement by giving it the role ofinspection of NHS organizations and service providers against thestandard set for NHS




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In response to the concerns being expressed about patient safety, governments – particularly the U.K. Department of Health – began to form new agencies and

design new processes to address the issue. The table below summarizes theinitiatives.

Organization Mandate/Process Started Budget

NHS Litigation Authority

Clinical Risk Management StandardsCompliance Assessments

1997

Department ofHealth

National Service Frameworks 1998

NHS Organizations Clinical governance 1998Commission forHealth Improvement

Investigate serious systemic servicefailures

Conduct clinical governance reviews

1999 £11.3M

National Institute forClinical Excellence

Health technology assessmentsDevelop clinical guidelinesPromote clinical audits

2000 £13.1M

National PatientSafety Agency

Mandatory reporting of errors andnear-misses

2001

Department ofHealth

Error Reduction/Elimination Targets 2001

National HealthService

Mandatory annual physicianappraisals

2001-2

National Clinical

Assessment Authority

Assess individual physicians referred

by employers

2002 £7.7M

National CareStandardsCommission

Regulate private and voluntary healthcare

2002

In the section below the initiatives are described individually, but it is important tonote that they also are inter-related. For example, a physician’s unsatisfactoryNHS appraisal could lead to the National Clinical Assessment Authoritybecoming involved. Given the newness of most agencies and processes all theinter-relationships have not yet been developed.

Error Elimination/Reduction Targets

In its response to An Organization with a Memory , the Government committeditself to four targets:




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1. To reduce to zero the number of patients dying or being paralysed by maladministeredspinal injections by the end of 2001

2. To reduce by 25% the number of instances of harm in the field of obstetrics andgynaecology which result in litigation by the end of 2005

3. To reduce by 40% the number of serious errors in the use of prescribed drugs by the endof 2005

4. To reduce to zero the number of suicides by mental health patients as a result of hangingfrom non-collapsible bed or shower curtain rails on wards by March 2002.

cxi

These targets were chosen because they are “visible and unambiguous” " andreflected "different facets of the problem of medical error". cxii Each target areahas an expert in the field assigned to look at ways of achieving the requiredreductions. As the reporting and analytical systems mature, new targets will beidentified.

NHS Clinical Governance 1999

The government’s 1998 White Paper, A First Class Service: Quality in the newNHS introduced the concept of clinical governance. In the U.K., “Every localNHS organization has a statutory duty to assure, monitor and improve the qualityof its services. This has been implemented through the clinical governanceprogramme.” cxiii

Clinical governance can be defined as a framework through which NHS organizations areaccountable for continuously improving the quality of their services and safeguarding highstandards of care by creating an environment in which excellence in clinical care willflourish.

cxiv

The components of clinical governance are:

• Education – continuing professional development of clinicians

• Clinical audit – measurement of performance against agreed standards

• Clinical effectiveness – measurement of intervention effectiveness

• Risk management – minimizing risks to patients, practitioners, and the organization

• Research and development – carrying out and implementing research

• Openness – processes open to public scrutinycxv

Every NHS organization must nominate a clinician to be responsible for clinicalgovernance and report to the chief executive and board.

The Commission for Health Improvement, described below, oversees clinicalgovernance.




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Commission for Health Improvement

As stipulated in the U.K. Health Act (1999), the functions of Commission forHealth Improvement (CHI) are to:

" provide national leadership to develop and disseminate clinical governance principles;

" independently scrutinise local clinical governance arrangements to support, promote anddeliver high quality services. The Commission will conduct a rolling programme ofreviews of clinical governance arrangements visiting each NHS Trust, Primary CareTrust, and Health Authority every four years;

" review and monitor local and national implementation of national guidelines in the form ofthe National Service Frameworks (NSFs) and National Institute of Clinical Excellence(NICE) guidance;

" help the NHS identify and tackle serious or persistent clinical problems. The Commission

has the capacity for rapid investigation and intervention to help put these right;

" increasingly take on responsibility for overseeing and assisting with external NHSincident enquiries in England and Wales;

" seek to identify excellence and celebrate and share good practice, thus producingbenchmarks. cxvi

The two prominent products of the Commission are investigations and clinicalgovernance reviews.

Investigations

As noted above, CHI investigates systemic issues and the National Clinical Assessment Authority assesses individual doctors. CHI investigations are done“into serious service failures in the NHS. These failures may be a breakdown ofprocesses and standards, a pattern of incidents of widespread public concern orother issues that remain unresolved through other reviews or investigations”:

A CHI investigation aims to improve patient care and to make recommendations to restore public confidence in the NHS.

CHI will establish the cause of failures in the NHS by looking at individual as well asorganisational practices. In an investigation, CHI will draw attention to areas that are failing

and make recommendations to ensure that improvement is achieved. The investigatorsorganisation's regional office in England or the National Assembly for Wales will ensure therecommendations are implemented.

CHI will publish a report on the investigation findings and recommendations, which will bemade public and available on CHI's website.

cxvii

To date CHI has released 6 investigation reports.




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Clinical Governance Reviews

CHI visits every NHS trust and health authority, including primary care groupsevery four years to conduct a clinical governance review. There are about 500

NHS organizations. CHI’s model for clinical governance and evaluation questionsare reproduced below.

CHI evaluates clinical governance by exploring three key, interlinked areas identified in themodel:

" Strategic capacity : how far does the trust’s leadership set a clear overall directionthat focuses on patients? How well is it integrated throughout the trust?

" Resources and processes: how robust are its processes for achieving qualityimprovement, such as consultation and patient involvement and clinical audit? Howeffective are the trust’s arrangements for staff management and development?

" Information: what information is available about the patient experience, outcomes, processes and resources, and how does the trust use it strategically and at the levelof patient care? cxviii

In its recent response to the Bristol Inquiry, the Government mentionedstrengthening CHI by giving it the role of inspection of NHS organizations andservice providers against the standard set for NHS, not just investigatingproblems.

CHI spent £11.3M in 2000-01. cxix




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National Institute for Clinical Excellence

The National Institute for Clinical Excellence (NICE) was established in 2000 " toprovide patients, health professionals and the public with authoritative, robustand reliable guidance on current “best practice”. cxx NICE has three roles:

• health technology assessment• clinical guidelines for the management of individual conditions

• promoting clinical audits

Technology Assessment

To date NICE has completed 31 technology assessments and has a further 32 inpreparation.

Clinical Guidelines

NICE has published five guidelines and has 31 others in preparation. Doctors“are expected to take the guidance fully into account when exercising theirclinical judgement”.cxxi

Clinical Audits

Clinical Audits monitor the use of particular interventions, or the care received by patients,against agreed standards. Any departures from "best practices" can then be examined inorder to understand and act upon the causes. We will recommend simple methods thathealth professionals can use to monitor how they follow the guidance offered by NICE. cxxii

NICE has a budget of £10.6 million, with an additional £2.5 million to coveradditional projects.

National Service Frameworks

According to A First Class Service, National Service Frameworks (NSF) will:

• Set national standards and defined service models for a specific service or care group

• put in place programs to support implementation

• establish performance measures against which progress within an agreed time scale willbe measured.

cxxiii

The developmental process is collaborative:

Each NSF is developed with the assistance of an external reference group (ERG) whichbrings together health professionals, service users and carers, health service managers,

partner agencies, and other advocates. ERGs adopt an inclusive process to engage the




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full range of views. The Department of Health supports the ERGs and manages theoverall process.

cxxiv

Currently there are NSF’s in place for: cancer, coronary heart disease, diabetes,long-term conditions, mental health, older people, paediatric intensive care, renalservices, and children's national services.




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Clinical Risk Management Standards

The NHS Litigation Authority (NHSLA) runs a Clinical Negligence Scheme forTrusts that “provide a means for trusts to fund cost of clinical negligence litigation

and to encourage and support effective management of claims and risk". Thescheme includes Clinical Risk Management Standards. cxxv Every three yearstrusts are assessed for compliance with the standards. Trusts may receive asmuch as a 25% discount on their premium if they attain the highest level ofcompliance.

Annual Physician Appraisals – NHS 2001-2002

Consultants/Specialists

As noted above in the section on Appraisal for consultants working in the NHS,

consultants working in the NHS must undergo an annual appraisal by a peer,starting April 1, 2001. The appraisee fills out a form that asks for information inthe following categories:

• Personal Details• Details of Current Medical Activities• Record of Reference Documentation

o Good medical careo Maintaining good medical practiceo Working relationship with colleagueso Relations with patientso Teaching and trainingo Probityo Health

• Management Activity• Health (personal)• Research• Development Activity

The appraisee also must submit a Personal Development Plan.

The appraiser and appraisee meet to discuss the information and the appraiser

then completes a form with his/her commentary and the “actions agreed” by theappraisee.

Upon completion all these forms are forwarded to the NHS Chief Executive.cxxvi The procedures state that, “If, as a result of the appraisal process the appraiserbelieves that the activities of the appraisee are such as to put patients at risk, theappraisal process should be stopped and action taken”. cxxvii




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The NHS appraisal system is designed to dovetail with the developing GeneralMedical Council five-year revalidation of fitness to practice.

GP Appraisal

Effective April 1, 2002, appraisal of general practitioners working in the NationalHealth Service is mandatory. The process is very similar to the consultants’process outlined above. The GP being appraised fills out a form, including adevelopment plan, and is interviewed by a peer GP trained to do appraisals.

According to the Department of Health, the process “is about identifyingdevelopment needs, not performance management. It is a positive process, togive GPs feedback on their past performance, to chart continuing progress andidentified development needs.” cxxviii

National Clinical Assessment Authority 2002

This new authority began operating in April 2002. It assesses individual doctors;the Commission for Health Improvement (CHI) – described below - assessessystemic issues.

The Authority's aim is to provide a support service to the NHS when concerns over the performance of an individual doctor are raised. The NCAA will take referrals from doctors'employers - NHS Health Authorities, Hospital Trusts, Primary Care Groups and Trusts.The Authority will deal with concerns about doctors in difficulty by providing advice, takingreferrals and carrying out targeted assessments where necessary.

The NCAA will not take over the role of an employer, nor will it function as a regulator.Rather, it will help the employer or health authority by carrying out an objectiveassessment. Following such an assessment, it will advise referring organisation onappropriate courses of action. This way, problems may be more effectively and speedilyaddressed. cxxix

NCAA reports are confidential, except when a statutory power to require theinformation is invoked, such as by the General Medical Council.

NCAA has memoranda of understanding with the Commission for HealthImprovement and the General Medical Council that outline how potentiallyoverlapping cases are to be handled.

In its Corporate Plan, NCAA anticipates annually doing 770 “advice” cases –where the issue is handled locally with NCAA advice – and 120 full assessmentsby 2004-05. cxxx NCAA has a budget of £7.7M in 20002-03. cxxxi




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National Patient Safety Agency 2001

One of the government’s responses to An organization with a memory was thecreation of a National Patient Safety Agency (NPSA):

The NPSA is an independent body created in July 2001 to co-ordinate the efforts of theentire country to report, and more importantly to learn from, adverse events occurring inthe NHS.

As well as making sure events are reported in the first place the NPSA is trying to promote a blame-free culture in hospitals, encouraging doctors to report incidents withoutfear of personal reprimand. It will then collect reports from throughout the country andinitiate preventative measures, so that the whole country can learn from each case, and

patient safety throughout the NHS will be improved every time.cxxxii

The NPSA has adopted the research questions posed by Building a safer NHSfor patients as action items:

1 What are the main types of error and adverse event in different healthcare settings?

2 What methodologies would ensure effective patient and consumer involvement to enhance patient safety?

3 What strategies would ensure early detection of new risks before they result in a rare butcatastrophic event?

4 How can organisational cultures be achieved that are safety conscious, "reporting-friendly"and free of blame?

5 What methods can reduce error in particular specialist fields of medicine (eg, drug therapy)?

6 How can equipment acquisition and management policies reduce risk?

7 How can data collation, classification and analysis be enhanced to allow patterns ofcausation, presentation, detection, and amelioration to be elucidated?

8 What are the characteristics of good leadership of clinical teams that have a good approach to performance in patient safety?

9 Why does change to improve patient safety so often fail to be implemented despitewidespread dissemination of strategies which have been shown to work?

cxxxiii

The NPSA’s major responsibility is to develop and operate a national errorreporting and analysis system. Its current state of development is described inthe section below, Error Reporting Systems and Data Analysis.




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National Care Standards Commission

The National Care Standards Commission (NCSC) is a new, independent publicbody set up under the Care Standards Act 2000 to regulate private and voluntaryhealth care services and social care throughout England. On 1st April 2002

NCSC took responsibility for the registration and inspection of services thatinclude the following independent (non-NHS) health care establishments, some ofwhich have been brought under regulation for the first time:

• Exclusively Private Doctors• Private walk-in medical centres• Independent medical agencies• Acute hospitals• Mental health hospitals• Hospices• Maternity hospitals or clinics•

Abortion clinics• Nurses Agencies• Establishments prescribed techniques and technologies

There are national minimum standards for independent health care that focus onensuring that patients receive treatment and services that are both safe andquality assured. cxxxiv

Section 15 of the Care Standards Act places a quality of treatment requirementon all private providers:

15. —(1) Subject to regulation 6(3), the registered person shall provide treatment andany otherservices to patients in accordance with the statement of purpose, and shall ensure thatthetreatment and any other services provided to each patient—(a) meet his individual needs;(b) reflect published research evidence, and guidance issued by the appropriate

professionaland expert bodies, as to good practice in the treatment of the condition from which the

patient is suffering; and(c) are (where necessary) provided by means of appropriate equipment.

The National Clinical Assessment Authority may provide services to the NCSC.

NHS Patient Safety Research Program

An Organisation with a Memory listed research questions that a new NHS PatientSafety Research Program is pursing. The questions are found on page 88 above.




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The program seeks to avoid duplication of research in other countries, especiallythat funded by the Agency for Health Care Research and Quality (AHRQ) in theUnited States. The program funds applied research with potential immediateimpact for Health Services. It is currently inviting proposals to be submitted.


The Department of Health is committed to introducing a mandatory reporting androot cause analysis system for adverse patient incidents in 2002. A system has

just been pilot-tested and decisions on nation-wide roll-out will be made in thefirst half of 2002. The sub-sections below outline the history of policydevelopment, and report on the pilot project evaluation.

An Organization with a Memory

As noted above, An Organization with a Memory and the Bristol Inquiry both

recommended the establishment of a mandatory national adverse incidentreporting system, and the government accepted these recommendations.

Building a safer NHS for patients

In its response to An Organization with a Memory , Building a safer NHS for patients, the government set out eight principles for the new national reportingsystem:

• mandatory for individuals and organizations

• confidential but open and accessible

• generally blame-free and independent• simple to use but comprehensive in coverage and data collection

• systems learning and change at local level and national levelscxxxv

It also gave a mandate to the new National Patient Safety Agency to begindeveloping the system.

Doing Less Harm

This Department of Health/NPSA consultation document was published in

August 2001.It outlines in some detail the proposed mandatory adverse event reportingsystem. It states:

The cornerstone of the requirements set out in this document is the need to establish theunderlying cause(s) of serious incidents through root cause analysis. Unless the causesof adverse patient incidents are properly understood, lessons will not be learned andsuitable improvements made to secure a reduction in the risk of harm to future




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patients…. Identifying and addressing dysfunctional systems is, therefore, the key toreducing future risk of harm… and is the ethos behind the new national system….

cxxxvi

It identifies 10 “key requirements” for local management, reporting, analysing andlearning from adverse events:

1. All individuals involved directly or indirectly in patient care are aware of what constitutesan adverse patient incident.

2. The incident is managed and reported to a designated person, or persons, in accordancewith local arrangements.

3. All serious incidents are reported immediately to a locally designated person, or persons,and, where appropriate, information on these incidents is "fast-tracked" to relevantexternal stakeholders.

4. All reported incidents are graded according to the actual impact on the patient, and the potential future risk to patients in the organization, and reviewed to establish stakeholderreporting requirements.

5. Adverse patient incidents are subject to an appropriate level of local investigation and

causal analysis and, where relevant, an improvement strategy is prepared.

6. Incidents graded as red, are reported to the National Patient Safety Agency within threeworking days of the date of occurrence. For category red adverse events only (i.e. whereserious actual harm has resulted), this information is also reported within three workingdays to the relevant Regional Office of the Department of Health.

7. For all category red incidents, a full root cause analysis is undertaken by the localorganization and reported to the National Patient Safety Agency within 45 working daysof occurrence of the incident. For category red adverse events only, (i.e. where seriousactual harm has resulted), this information is also reported within 45 working days to therelevant Regional Office of the Department of Health.

8. Where appropriate, the organisation co-operates with the Department of Health toestablish the need for an independent investigation or inquiry, and also co-operates withother stakeholders who might be required to undertake investigations and/or inquiries intothe circumstances surrounding a particular adverse patient incident.

9. Aggregate reviews of local incident data/information are carried out on an ongoing basisby the organisation and the significant results communicated to local stakeholders.

Aggregate review reports are sent to the National Patient Safety Agency on a quarterlybasis.

10. Lessons are learned from individual adverse patient incidents, from local aggregatereviews and from wider experiences, including feedback from the National Patient Safety

Agency, other agencies/bodies and benchmarking. Improvement strategies aimed atreducing risk to future patients are implemented and monitored by the organisation.Where appropriate, local staff learn lessons and change practice in order to improve thesafety and quality of care of patients.

cxxxvii

The minimum data set for reporting an incident is reproduced below:

• Date of making report

• Reporting organisation

• Reporter (Name, job title, telephone, e-mail)

• Apparent outcome of incident in terms of harm (from matrix below)




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• When the incident occurred? (date/time)

• Where the incident occurred? (specialty/location)

• Who was involved? (patient and staff descriptions, not names, gender, age andethnic group)

• What happened? (including medical devices/equipment and/or medicines involved)

• What immediate action was taken?

•Whether information on the incident has been or will be reported to another agencyor body?

cxxxviii

The reporter subjectively grades the incident in terms of the degree of risk ofharm and the likelihood of recurrence on the charts below by marking a box oneach of the charts.

Source: Doing Less Harm, p. 24

As noted in point 7 of the Key Requirements above, a root cause analysis ofcategory red incidents must be submitted to NSPA. The document provides anoverview of root cause analysis and recommends some factors that should be

reviewed.

The minimum data set for the root cause analysis report is below:

• Context (Statement of problems(s); patient details, including co-morbidity; stage of care;etc.)

• How did the incident happen? (immediate cause(s))




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• Why did the incident happen? (Underlying/root cause(s))

• What preventive action was taken or proposed?

• What impact did the incident have (on the patient(s) and the organisation, includingmedia attention, increased length of stay and levels of care, impact on key objectives(e.g. waiting lists), and financial costs)?

• What factors did or could have minimised the impact of the incident?cxxxix

The document also outlines the agencies that might use information from thereporting and root cause analysis systems:

• Centre for Communicable Disease Control • Commission for Health Improvement • Confidential Inquiries • Coroner • Department of Health • Environmental Health • Food Standards Agency • Health Authority • Health and Safety Executive • Home Office – mental health notification

• Medical Devices Agency

• Medicines Control Agency

• National Patient Safety Agency

• NHS Estates – fire code

• NHS Litigation Authority

• Police

• Primary Care Trust

• Professional regulatory bodies• Public Health Laboratory Service

• Serious hazards of transfusion (SHOT) cxl

Pilot Project

Between November 2001 and April 2002 the National Patient Safety Agency rana pilot project reporting system at 28 NHS Trusts in England and Wales. Thesystem solution obtained was from the Australian Patient Safety Foundation. Thekey findings of the evaluation were:

• It is vitally important to have local executive and board buy-in to theobjectives of reporting and improving patient safety locally

• Such buy-in required a comprehensive communication and educationprogram

• NPSA needs to consider multiple approaches to risk assessment, whileencouraging standardized outputs




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• Systems need to be simplified to make transmission of data asstraightforward as possible

• Data category codes need to be standardized• In-depth data should be collected from areas of importance such as

obstetricscxli

Preliminary Data from the 28 pilot project sites were announced in June 2002:

• 27,110 incidents reported• 135 patients died – 35 from suicides• 2% of incidents considered catastrophic or very serious• 31 reports involving potassium chloride, with three deaths cxlii

On the basis of these data the Chief Medical Officer estimated that one in tenhospital patients – one million per year - are accidentally injured.




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PUBLIC AND MEDIA OPINION

Action for Victims of Medical Accidents

The organization Action for Victims of Medical Accidents (AVMA), a charityspecializing in providing free independent advice and support to patients whohave suffered a medical accident, was set up in 1982. According to its website,

In addition to helping individuals, AVMA campaigns tirelessly for a more effective systemfor preventing avoidable medical accidents. AVMA also works closely with selectedmembers of the legal profession to ensure that patients have effective, responsive andsympathetic redress for what they have suffered…. Above all AVMA works to raisemedical and legal standards and to ensure accountability when things have gone wrong.Our work is now recognised by many public organisations. For example we are uniquelyendorsed to by the Legal Services Commission to select and accredit which solicitors areable to apply for public funding for medical accidents. (The only other organisation

authorised to do this is the Law Society).

cxliii

AVMA spokespersons are often interviewed by the media about patient safetyissues.

Media Coverage

Media coverage of both medical errors and governments’ responses has beenextensive. For example, the BBC carried 33 stories about the Bristol Inquiry, theGuardian 30, the Times 11, and the Telegraph 11. cxliv




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Malpractice Insurance Issues

Background

The U.K. has a mixed public/private system of providing health care institutionsand physicians with malpractice liability protection. The National Health ServiceLitigation Service (NHSLS) covers many NHS trusts, including doctors working intrust hospitals. It currently handles 42% of claims. General practitioners workingoutside NHS hospitals are covered by medical protective associations or privateinsurers.

As reported above, a recent audit of NHSLS found the following:

• The total annual charge to NHS income and expenditure accounts forprovisions for settling claims has risen sevenfold since 1995-96

• The rate of new claims per thousand finished consultant episodes rose by72% between 1990 and 1998

• In 1999-2000 the NHS received 10,000 new claims and cleared 9,600;there were an estimated 23,000 claims outstanding

• The estimated net present value of outstanding claims was £2.6 billion inMarch 2000

The charts below illustrate the growth in costs and claims.

Source: National Health Service Litigation Authority, Report and Accounts 2001,p. 29




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Source: National Health Service Litigation Authority, Report and Accounts 2001,p. 30

The tailing off of these charts in recent years does not necessarily indicate areduction in claims, but rather that numerous claims have not yet been reported.

The National Audit Office report found that in 65% of settlements in 1999-2000below £50,000, the legal and other costs exceeded damages awarded. cxlv In

response, the NHSLS is proposing “to launch a Small Claims Manifesto, wherebyfor low value claims, without litigation and for fixed costs, we will offer a fixedtimetable to claimants for resolution of their claims”. cxlvi

Bristol Report

The Bristol Report, published in July 2001, recommended:

In order to remove the disincentive to open reporting and the discussion of sentinelevents represented by the clinical negligence system, this system should be abolished. Itshould be replaced by an alternative system for compensating those patients who sufferharm arising out of the treatment from the NHS. An expert group should be establishedto advise on the appropriate method of compensation to be adopted.cxlvii

White Paper

The government response, Learning from Bristol , stated:




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We agree that the current system of clinical negligence compensation needs to bereformed. A White Paper will be published early in 2002 setting out proposals for reformsto the system. This will be informed by a committee, chaired by the Chief MedicalOfficer, which is reviewing all the potential options for reform. cxlviii

The White Paper has not yet been released. The Chief Medical Officer has

published a consultation document entitled Call for Ideas that contains a list ofpolicy questions that are reproduced below.

• What are the current barriers to resolving complaints and concerns raisedby patients quickly and efficiently? What changes would help to overcomethese? What might be the benefits and dis-benefits of such changes?

• Which elements of the current system contribute most to the trauma offollowing through complaints and concerns - both for patients andclinicians? What changes would help to overcome these? What might bethe benefits and dis-benefits of such changes?

• What is it about the current system which limits its perceived fairness andtransparency? How might the system be changed to improve consistency?What might be the benefits and dis-benefits of such changes?

• Are there any barriers in the current system to NHS organisationsmanaging clinical risk as effectively as they might and, if so, what changeswould help to address these? What might be the benefits and dis-benefitsof such changes?

• What changes to the current system for dealing with clinical negligence

claims would help to ensure that the appropriate lessons were learned frommistakes and further strengthen the incentives to improve the quality ofclinical care? What might be the benefits and dis-benefits of such changes?

• Which characteristics of the current system contribute to the increasingoverall costs to the taxpayer of dealing with clinical negligence claims?What changes to the system might help to control overall costs? Whatmight be the benefits and dis-benefits of such changes?

• What changes to the current system would help to reduce the proportion ofcosts which are paid out to cover legal and administrative costs, rather thandamages? What might be the benefits and dis-benefits of such changes?

• Looking at the range of potential options for change which there might be inyour view, what barriers are there within the current NHS and legal systemswhich could prevent their swift implementation? Might there be anyunacceptable implications or effects on wider systems or other areas oflitigation and, if so, what are they?




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• What are the key examples of existing no-fault compensation schemeswhich the committee should examine in considering potential models forchange? And what are their benefits and dis-benefits?




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• What would be the potential benefits and dis-benefits in introducing asystem of fixed tariffs for specific injuries? How feasible would it be tointroduce such a system? What would be the barriers to change? Wouldsuch a system be most valuable if applied to small and medium-sizedclaims only, or for all claims? How might such a system work in practice?How could it interact with the NHS complaints procedure?

• What would the implications be of such no-fault or fixed tariff schemes forother personal injuries litigation?

• How do you perceive the current interface between the NHS complaints procedure and the system for dealing with clinical negligence claims? Whatwould be the benefits and dis-benefits of integrating the two systems tostreamline the resolution of concerns generally?

• What are the potential benefits and dis-benefits of the courts having the power to impose structured orders as well as lump sum orders?

• What would the implications of imposed structured orders be for other personal injury litigation?

• What are the benefits and dis-benefits of the current provision in statute(Law Reform (Personal Injuries) Act 1948 S2(4)), which allows claims toreflect the cost of private, rather than NHS care. Would there be any

potential adverse consequences from repealing that provision?

• What is the potential scope, looking at the possible benefits and dis-benefits, for addressing patients' future care needs though indemnitiesrather than up-front damages payments?

• What are the potential advantages, disadvantages and barriers to theestablishment of a formal Rehabilitation Initiatives, to limit the effect ofinjuries and their consequent trauma and financial loss? Are there anylimitations, in terms of existing expertise and capacity within NHS andSocial Services, which affect the practicality of introducing such aninitiative? How might these limitations be overcome?

• What might be the value in setting up a tribunal or commission to mediate,

arbitrate or determine claims? What would be the disadvantages? Howmight such a body work? Are there any existing organisations whose rolecould be developed to undertake such a function? How might it interact witha system for no-fault compensation, fixed tariffs or the NHS complaints

procedure?




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• What are the advantages of mediation? Are there any disadvantages?What are the current barriers to the use of mediation and other alternativedispute resolution techniques within the current system? What changescould be made which strengthened the incentives to mediate rather thanlitigate, and maximise its success in resolving concerns without adding tothe overall cost to the taxpayer? Should mediation be compulsory? Whatwould be the implications, here and elsewhere, of making it compulsory?

• What, if any, inconsistency is there between the funding arrangements forclaimants and defendants costs? What changes might be appropriate toimprove the control of costs generally and strengthen incentives to bringclaims (especially large ones) to an early conclusion and address thedisproportion of costs to damages in relation to small and medium-sizedclaims?

• What operational links should there be between the system for dealing with

clinical negligence claims, the clinical governance framework, riskmanagement processes and adverse incident reporting? What, if any,barriers are there to putting these in place?

cxlix

On the day of publication of this consultation document, the Guardian reportedthat, " …ministers hope [these measures] will cap the spiralling legal costs ofclaims against the NHS". cl

In the meantime, Professor Ian Kennedy, the head of the Bristol Inquiry,continues to lobby for an entirely no-fault system. He has rejected the option of asystem of fixed rate payments for specific medical injuries, with patients still free

to sue if they are dissatisfied. "Allowing two or three people to sue causeshundreds of thousands not to find certain things." cli

Patient Complaints

The NHS has a formalized complaints procedure. Complainants may seek localresolution of their complaint or they may proceed to a non-local independentreview.The Bristol Inquiry made recommendations about reforming this system to makeit more responsive:

There should be a clear system, in the form of a ‘one-stop shop’ in every trust, foraddressing the concerns of a patient about the care provided by, or the conduct of, ahealthcare professional.

clii

The results of a recent review confirmed that the current complaints procedure isnot working at all well from the perspective of complainants:




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• Among individuals whose complaint was dealt with locally, only one-third believe thattheir complaint had been handled well. No more than 20-30% were satisfied with thetime taken to deal with the complaint and a majority were dissatisfied with the outcome.

A majority thought that the current procedure was either unfair or biased and a high proportion found the process to be stressful or distressing.

• Among individuals who had requested independent review, around one quarter believed

that their complaint had been handled well. No more than one in ten were satisfied withthe time taken to resolve their complaint and only 13% were satisfied with the outcome. Almost three-quarters believe that the complaints procedure is either unfair or biased. Asignificant majority found the process to be stressful or distressing.

• The main causes of dissatisfaction among complainants are operational failures:unhelpful, aggressive or arrogant attitudes of staff, poor communication and the lack ofinformation and support. The most important structural failure is the perceived lack ofindependence in the convening decision and in the review process generally. cliii

The Government is introducing reforms to the complaints process. This includesintroducing a Patient Advocacy and Liaison Service (PALS) into every NHSTrust. One hundred “pathfinder” PALS were funded in 2001-02 at a cost of £10M.cliv

Role of Professional Governing Bodies

Council for the Regulation of Health Care Professionals

In August 2001 the Government published a consultation document, ModernisingRegulation in the Health Professions. The introduction states:

It is clear from the Kennedy Report [Bristol Inquiry] and the experience of professionalregulation in recent years that there are weaknesses in the current arrangements which

need to be addressed by reforms to the individual regulatory bodies, stronger and moreeffective co-ordination of their work and clearer and more robust accountabilitymechanisms.

clv

Legislation – the National Health Services Reform and Health Care ProfessionsBill – has been introduced and is scheduled for further debate this fall. The Billcontains provisions for the establishment of a Council for the Regulation ofHealth Care Professionals, as recommended by the Bristol Inquiry. The Councilwould have a majority of public members appointed by governments, and aminority of members appointed by the professional governing bodies.

The Council would have the authority to:

• investigate and report on the performance of each regulatory body• recommend changes to how regulatory bodies perform their functions• direct a regulatory body to make rules, regulations, by-laws and schemes• appeal any regulatory body disciplinary decision it considers too lenient




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The intention is to make the professional regulatory bodies accountable to theCouncil; it would in turn report to the Parliaments and the Welsh Assembly.

Impact of Other Reforms

The other recent reforms in Britain, including the establishment of numerous newstandard-setting and investigatory agencies, seems to have put in place parallelsystems for all governing bodies’ functions except entry to practice anddiscipline.

For example:

• practice standards are set by the National Institute for Clinical Excellence• annual physician appraisals are carried out by the NHS

• physicians whose fitness to practice is being questioned by theiremployers are assessed by the National Clinical Assessment Authority

•errors will be reported to the National Patient Safety Agency

• patients complaining about the care they receive complaining to their localNational Service Trust, all of whom will have Patient Advisory and LiaisonServices

• the proposed Council for the Regulation of Health Care Professionalswould be able to appeal a discipline decision it considers to be lenient

Governing bodies are often partners or recipients of information from these othersystems, but the public and the rest of the health care system do not need to relyexclusively on the jurisdiction of a governing body to have a complaintinvestigated.

The General Medical Council in particular does not seem to be keeping pace withthe government’s reforms. Its proposals for mandatory physician revalidation areon a five-year implementation schedule, while the government’s own parallelreforms will be accomplished well before then.

Qualified Privilege

We have been unable to discover at this point whether there is any statutoryprotection of information collected for quality review purposes. However, NPSA

says:

All information supplied to the NPSA, through the national reporting system, will beanonymous. Reports made to the NPSA outside of the national reporting system, by

patients or by staff for example, will be confidential.clvi




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GAPS

With at least seven national agencies involved in patient safety initiatives, theissue may be one of overlaps rather than gaps.

The UK government recently announced that it is creating a new Commission forHealthcare Audit and Inspection (CHAI) that will bring together the AuditCommission, Commission for Healthcare Improvement and National CareStandards Commission.




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FUTURE PLANS

Announcements Made In Response to Bristol Inquiry, January 2002

Council for the Quality of Health Care and Council for the Regulation ofHealthcare Professionals

The Bristol Inquiry recommended that two new councils be established to bringtogether the various bodies that regulate health care. “These overarchingorganizations must ensure that there is an integrated and co-ordinated approachto setting standards, monitoring performance, and inspection and validation.Issues of overlap and of gaps between the various bodies must be addressedand resolved.” clvii The Government accepted these recommendations but hasnot yet set up the councils. Legislation to establish the “Regulation” council hasbeen introduced. The councils will report to Parliament. clviii

The government “will take further steps at the earliest opportunity to rationalisethe number of bodies inspecting and regulating health and social care”. clix

White Paper on Clinical Negligence

The government announced that it would publish a White Paper on clinicalnegligence “early in 2002”. To date, this paper has not been published. Acommittee headed by the Chief Medical Officer is consulting widely about theissues and options. clx

National Knowledge Service

A National Knowledge Service will support the delivery of high quality informationfor patients and staff. clxi

Publication of Clinical Performance Data on Consultants and Their Teams

In the future data on the performance of consultants and their units/teams will bepublished for the use of both clinicians and patients. clxii

Electronic Patient Records

Electronic patient records will be introduced by 2005 and will “act as a buildingblock for the other information the NHS needs in order to monitor quality”. clxiii




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Other Future Initiatives

General Medical Council 5-Year Revalidation

Although the General Medical Council and the government have agreed to

introduce mandatory five-year revalidation of physician’s licenses, the legislationhas not yet passed and plans are still being developed:

In relation to revalidation, precise policy is still being developed and the informationcurrently available on this site is intended to give a broad outline of the process ofrevalidation and what is required. Also, although it is recommended that doctors begincollecting information for revalidation as soon as legislation is passed, they will not berequired to submit this information to the GMC for several years. clxiv

Audits of Clinical Governance

The National Audit Office plans two “studies to examine the success of theses

initiatives; one will look at clinical governance in hospitals; the other at clinicalgovernance in primary care”. clxv




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UNITED STATES

BACKGROUND

Health Care System

The U.S. health care system is typically described as an outlier in theOrganization for Economic Cooperation and Development. It has the highestlevel of spending and one of the lowest levels of government spending, althoughthe government at the federal, state, and local levels do provide more than 1/3 rd of total health care funding through:

• the Medicare Program (national insurance scheme for citizens 65 years ofage and older and those with disabilities)

• the Medicaid Program (state-level system of insurance for a portion of theindigent and low-income populations)

• the Veterans Administration to veterans• the Department of Defence to active members of the military

• the Federal Bureau of Prisons to federal prisoners

The federal government is the largest supporter of biomedical and healthservices research through the National Institutes of Health, the Centers forDisease Control and Prevention, and the Agency for Healthcare Research andQuality.

Health care organizations are accredited by the Joint Commission on Accreditation of Healthcare Organizations, providers are licensed by statebodies, and professional qualifications (e.g. specializations) are typically awardedby national colleges. Health care is typically highly managed whether provided bya public or private actor.




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REPORTS AND STUDIES

Harvard Medical Practice Study - 1991

This research, reported in the New England Journal of Medicine, was the firstlarge scale study of the incidence of adverse events in hospitals. Theresearchers, Lucian Leape, Troyen Brennan and others, based at HarvardUniversity, used chart reviews of 30,195 patients in 51 New York State hospitalsto determine the number who had been injured as a result of their care. Overall,3.7% had injuries; 58% of these events were judged to be preventable. Negligentcare was responsible for 28% of all injuries. A two stage screening process wasused to derive these rates. Trained nurses or health record technologists using18 screening criteria first screened the records. If the records met one or more ofthese criteria, they were then reviewed independently by two physicians whoidentified adverse events and instances of negligence.

In the study an “adverse event” was defined as “an unintended injury that wascaused by medical management and that resulted in measurable disability”.Negligence as defined as “failure to meet the standard of care reasonablyexpected of an average physician qualified to take care of the patient in question”The most common type of adverse event uncovered in the study were operativeevents, including wound infections and complications, which comprised abouthalf of the total events. The most common non-operative events were drug-related adverse events, which comprised 19% of all adverse events.

The methods used in the Harvard study have been the basis of subsequent

studies of hospital based adverse events in Australia, the U.K., New Zealand,and Denmark. A second U.S. study, using similar methods to review hospitalrecords in two states, Utah and Colorado, was carried out in the late 1990s. TheUtah/Colorado study found an incidence of adverse events of 2.9%.Extrapolation from the two US studies was used by the Institute of Medicine in itsreport, To Err is Human, to derive the estimate that between 44,000 and 98,000

Americans die in hospital each year as a result of adverse events.

To Err is Human - 1999

To Err is Human was the first of several reports issued by the Quality of HealthCare project undertaken by the Institute of Medicine, a non-profit organization inthe U.S. This report is credited as a major impetus in bringing the issue of“patient safety” to the forefront in the US. Its impact was based on its cogent andmedia savvy summary of the research literature on adverse events (notably theestimate of 44,000 to 98,000 deaths each year as a result of adverse events in




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US hospitals) and on the prestigious and influential panel that contributed to thereport.

The overall mandate of the committee was to develop a strategy that would resultin a “threshold improvement in quality over ten years”. The issue of adverse

events was seen by the committee as a critical marker of quality of care, and onethat would capture the interest of the public. Hence this issue was dealt with in aseparate publication. Moving beyond a summary of the research evidence, thereport offers a view of safety building on the experience of other industries, andthe lessons learned by anaesthesia to create safer systems.

The report recommendations lay out a national agenda for reducing “errors” inhealth care and improving patient safety in a four-tiered approach. These include:

• establishing a national focus to create leadership, research, tools andprotocols to enhance the knowledge base about safety;

• identifying and learning from errors through immediate and strongmandatory reporting efforts, as well as the encouragement of voluntaryefforts, both with the aim of making sure the system continues to be madesafer for patients

• raising the standards and expectations for improvements in safety throughthe actions of oversight organizations, group purchasers and professionalgroups; and

• creating safety systems inside healthcare organizations through theimplementation of safe practices at the delivery level.

Among the key recommendations of the report are the establishment of a Centerfor Patient Safety within the Agency for Healthcare Research and Quality(AHRQ), focused on setting national goals for patient safety, tracking progress onthese goals and developing a research agenda for understanding errors in healthcare.

The most controversial aspect of the report was its embrace of mandatoryreporting of adverse events that result in death or serious harm. The reportrecommended that hospitals and other institutions and ambulatory programsshould be required to report such events to an independent body, the NationalForum for Health Care Quality Measurement and Reporting. The reportsimultaneously recommends the development of voluntary reporting effortsassisted by the Center for Patient Safety. To protect institutions andprofessionals from the impact of such reporting, the committee recommendedthat Congress pass legislation to extend peer review protections to patient safetyand quality improvement data.




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Other recommendations in the report address the setting of performancestandards and expectations for safety and implementing safety systems in healthcare organizations.




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Doing What Counts for Patient Safety - 2000

The Quality Interagency Coordination Task Force was created by PresidentClinton as an umbrella organization coordinating efforts by US federal agencies

to improve the quality of health care in America. Following the release of the IOMreport, To Err is Human, President Clinton asked the Task Force to conduct areview of the report. The specific mandate of the Task Force was to evaluate therecommendations of the IOM report and to develop a strategy to identify threatsto patient safety and ways to reduce health care errors.

The QuIC agencies identified a number of key activities that could be undertakenby the federal government to reduce errors, implement a system of publicaccountability, develop a robust knowledge base about medical errors, andchange the culture in health care organizations to promote the recognition oferrors and improve patient safety. The report proposed:

• the development of a Center for Quality Improvement and Patient Safetyat AHRQ

• the establishment of mandatory state-based reporting systems to collectstandardized information on adverse events

• the development of safety measurement that would permit theidentification of healthcare errors, and

• the identification of patient safety practices that would reduce theincidence of adverse events.

In addition to mandatory reporting, the QuIC report advocates the developmentof voluntary reporting systems, the setting of patient safety performancestandards and the implementation of medication systems and other methods toimprove patient safety. Specific strategies were identified for healthcareorganizations, such as veterans and other hospitals administered by federalagencies.

Making Health Care Safer - 2001

This report, commissioned by the Agency for Healthcare Research and Quality,evaluated existing patient safety practices. The authors reviewed 79 practicesand rated them in terms of evidence to support more widespread implementation.The results are described below in the “Assessments of Patient Safety Initiatives”section.




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Crossing the Quality Chasm: A New Health System for the 21st Century

In March 2001, the Institute of Medicine Committee on the Quality of Health Carein America released its second major report, Crossing the Quality Chasm. The

report provides a wide-ranging analysis of the sources of poor quality in UShealth care and offers a detailed agenda for improving performance. The reportbegins with a critical overview, based on a detailed assessment of the researchliterature of the quality problems in US health care. The authors identify thefailure to make best use of available resources, the difficulties in translatingresearch advances into practice, the inadequate implementation of informationtechnology, and the failure to develop system approaches to chronic illness careas critical problems for US health care.

As an approach for improving performance the report urges the adoption of sixaims. Health care should be:

• safe – avoiding injuries to patients from the care that is intended to helpthem

• effective – proving services based on scientific knowledge to all who couldbenefit and refraining from providing services to those not likely to benefit

• patient -centered – providing care that is respectful of and responsive toindividual patient preferences, needs, and values and ensuring that patientvalues guide all clinical decisions

• timely – reducing waits and sometimes harmful delays for both those whoreceive care and those who give care

• efficient —avoiding waste, including waste of equipment, supplies, ideas

and energy • equitable – providing care that does not vary in quality because of

personal characteristics such as gender, ethnicity, geographic location,and socio-economic status.

The current system is seen as incapable of providing the high quality of careenvisioned through the six aims. Instead, the committee argues that there is aneed for a new system design, based on “new rules”. These rules would supporta system that was designed to meet the needs of patients and to ensure thatthey are fully informed, retain control and participate in care delivery whereverpossible, and receive care that is respectful of their values and preferences. At

the same time, the new system should ensure that scientific knowledge aboutcare was available to caregivers. The 10 new rules are:

1. Care based on continuous healing relationships2. Customization based on patient needs and values3. The patient as the source of control4. Shared knowledge and the free flow of information




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5. Evidence-based decision making6. Safety as a system property7. The need for transparency8. Anticipation of needs9. Continuous decrease in waste

10. Cooperation among clinicians

To create a new system based on the six aims and the new rules will requiretransformation at four levels: the individual practitioner, health care teams or“microsystems”, organizations and the broader systems that support care.Specific recommendations are outlined at each of these levels.

The Chasm report provides a detailed and theoretical framework for improvingthe quality of health care in America. The issues of patient safety and thereduction of health care errors are critical parts of this analysis, but they arewoven into a broader discussion of system change. Unlike the first report, To Err

is Human, the Chasm report has received much less media and public attention.However, the IOM has developed a series of dissemination exercises, includingworkshops for professionals and educators designed to help translate the reportinto action.




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The US system is typified by a diversity of initiatives. Some of these, such as theNational Coordinating Council on Medication Error Reporting and Prevention that

started in 1995, represent early privately-initiated responses to research onmedical errors. Virtually all of the organizations operating on a national level havecoordination of existing initiatives as one of their goals and the support of avoluntary or mandatory reporting system. Although virtually all of theseorganizations also endorse a culture of safety and the importance of a system-level response, they all also focus on the promulgation of best practices storiesthat highlight individual or institutional level activity.

The US response is also distinguished by its strong focus on adoption of existingpatient education initiatives. A number of organizations provide guidance ondiscussing medical errors with patients and their families and a number of others

such as the National Council on Patient Education and Information have rolledpatient safety into their mandate.

Finally, the US experience can also be characterized by the strong private sectorpresence and the integration of this presence into government policy (e.g. theNational Quality Forum officially launched by then Vice-President Al Gore). TheNational Patient Safety Foundation (see below) derives strong support from theprivate sector, while organizations such as Mederror provide a wealth ofcontinuing education materials around patient safety for providers.

Targets - 2000

Clinton AdministrationOn February 19, 2000, President Clinton adopted the target set by Institute ofMedicine in To Err is Human, namely to reduce medical errors by 50% over fiveyears. His statement:

• outlined the scope and size of the medical error problem• announced $20 million new funding for research to reduce errors

• required that all 6000 hospitals participating in Medicare have errorreduction programs in place

• provided $33 million for error reporting systems at the Food and Drug Administration

• announced substantial efforts to automate order entry and other errorreduction initiatives at Department of Defense and Veterans

Administration hospitals• expanded peer review protections, and• initiated 100 hospital data collection pilot projects




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Centers for Disease Control

The Centers have identified seven challenges that are linked to this 50%

reduction target:

1. Reduce catheter-associated adverse events by 50% among patients inhealthcare settings

2. Reduce targeted surgical adverse events by 50%

3. Reduce hospitalizations and mortality from respiratory tract infectionsamong long-term care patients by 50%

4. Reduce targeted antimicrobial-resistant bacterial infections by 50% by:

a. preventing infections; diagnosing and treating infectionsappropriately;

b. optimizing antimicrobial use, and

c. preventing transmission in healthcare settings;

5. Eliminate laboratory errors leading to adverse patient outcomes

6. Eliminate occupational needlestick injuries among healthcare personnel

7. Achieve 100% adherence to ACIP (Advisory Committee on ImmunizationPractices) guidelines for immunization of healthcare personnel

Quality Interagency Coordination Task Force (QuIC) - 1998

The QuIC is an umbrella organization - originally co-chaired by the Secretaries ofHealth and Human Services and Labour - organized to coordinate FederalGovernment efforts to reduce error. The stated goal of QuIC is:

… to ensure that all Federal agencies that purchase, provide, study, or regulate healthcare services are working in a coordinated way toward the common goal of improving thequality of care. The QuIC seeks to provide information to help people make choices, toimprove the care purchased and delivered by the Government, and to develop theinfrastructure needed to improve the health care system.

Federal Government agencies involved include:

• Agency for Healthcare Research and Quality (lead agency for the federal governmentand support for research in patient safety)

• Centers for Disease Control (support efforts in infection reduction)

• Healthcare Financing Administration, now the Commission for Medicare Services (errorreduction through Peer Review Organizations),




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• Veterans’ Affairs and Department of Defence (error reduction through improved patientcare processes).

• Office of Personnel Management,

• US Coast Guard

• Federal Bureau of Prisons

• National Highway Transportation and Safety Administration

• Federal Trade Commission

• Office of Management and Budget

• Department of Commerce.

QuIC has responded to all of the IOM recommendations and endorsed virtuallyall of them with the exception of those areas where it sees federal-state

jurisdictional issues or logistical barriers (such as data collection). Responsesand strategies by individual organizations are detailed below.

QuIC is linked to the Agency for Healthcare Research and Quality, which isdescribed below.

Agency for Healthcare Research and Quality (AHRQ)

The AHRQ is the health services research arm of the U.S. Department of Healthand Human Services (HHS) and the lead federal organization on patient safetyand the chief funding source for research on patient safety. It supported therelease of a systematic review of the literature entitled Making Health Care Saferby the Evidence Based Practice Center at the University of California at San

Francisco and Stanford University, described below.

It has launched at least five distinct RFA on patient safety research. Each hasfocussed on different topics. The most recent one seeks proposals to:

(1) explore the relationship between working conditions that affect health careworkers and the safety and quality of care they provide, and

(2) test innovative approaches to working conditions that have been effective inimproving the quality of a product or service in other industries. clxvi

It has supported conferences and educational programs and published severaldocuments targeted towards hospitals, providers, researchers, the media, andpatients. clxvii

The paragraph below outlines AHRQ’s budget and illustrates that patient safetyis AHRQ’s top budget priority:

For Fiscal Year (FY) 2003, the President has requested from Congress an appropriationof $251,700,000, a decrease of $48,659,000 (16.2%) from the Agency's FY 2002




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appropriation. The request provides a $5 million increase for the Secretary's PatientSafety Initiative, maintains funding for several priority programs, provides no new fundsfor non-patient safety research and training grants, and reflects a $33,754,000 generalreduction to grant and contract commitments.

clxviii

AHRQ research is described immediately below.

AHRQ Research Projects

The Agency for Healthcare Quality and Research in 2001 “awarded almost $50million for 94 new grants, contracts, and other activities to fund research aimed atreducing medical errors and improving patient safety”.

There are six categories of funding:

• Supporting demonstration projects to report medical errors data (24 projects, $24.7million)

• Using computers and information technology to prevent medical errors (22 projects, $5.3million)

• Understanding the impact of working conditions for health care workers on patient safety(8 projects, $3 million)

• Developing innovative approaches to improving patient safety (23 projects, $8 million)

• Disseminating research results (7 projects, $2.4 million)

• Additional patient safety initiatives (10 projects, $6.4 million)

AHRQ is also funding a Patient Safety Research Coordinating Center to assistresearchers to interact.

AHRQ’s research priorities are:

• the epidemiology of errors – e.g. the types and rates of errors in different health caresettings

• the infrastructure to improve patient safety – e.g. needed analytic capacity andorganizational culture

• information systems – e.g. development of common definitions of a reporting system andhow to evaluate its success; and

• knowing what interventions should be adopted and how to encourage adoption of patientsafety practices

clxix

The funded projects will be evaluated by the Patient Safety Program EvaluationCenter , described below in the “Assessments of Patient Safety Initiatives”section.




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Veterans Administration (VA)

The VA has adopted several approaches to reducing error and promoting safetythrough its 172 hospitals.

VA National Centre for Patient Safety

This centre focuses on prevention of error through use of root cause analysis andwork based on high reliability organizations. They run a web-based clxx information service that includes information on tips for reducing error, commonlyrequested resources, and a course of health care failure mode effects analysisand root cause analysis. They also focus very strongly on the development of aculture of safety that focuses on prevention instead of punishment.

Error Reduction Efforts by the VA and DoD.

These are well summarized in the QUiC report reproduced below:

The Department of Defense (DoD) and the Department of Veterans Affairs (VA), servingover 11 million patients nationwide, have begun to implement computerized physicianorder entry systems, proven effective in reducing medical errors. In addition, Veterans

Affairs has implemented a computerized medical record in all their 172 hospitals, makingit possible to reduce errors by providing complete information about patients at the pointof care. Over the past three years, the VA created an error reporting system, establishedfour Centers of Inquiry for Patient Safety, and began to use barcode technology to reducemedication errors” It is also worthwhile noting the VA operates a mandatory errorreporting system for adverse events that should soon include a voluntary system thatcollects data on near-misses. Plans for the voluntary system include its operation by an

independent external group and a method for disseminating error reports and alerts to allVA hospitals.

clxxi

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

The Joint Commission evaluates and accredits more than 17,000 health careorganizations and programs in the United States. An independent, not-for-profitorganization, JCAHO is the U.S.’s predominant health care standards-setting andaccrediting body.

The JCAHO has taken a lead in the reporting of patient safety problems and hasstated that patient safety reporting should be limited to major errors if mandatory,that it should include root cause analysis, and that it should be backed up bydissemination strategies and periodic evaluation of initiatives to reduce error. clxxii

Although JCAHO provided a reporting mechanism for hospitals for a period oftime, this effort has been suspended. It also provides a sentinel event report that




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describes causes and solutions for sources of error clxxiii and has struck anadvisory committee on patient safety.

Although patient safety practices have been included in its guidelines foraccreditation, application of these standards has also been temporarily

suspended. JCAHO’s official involvement in patient safety is its sentinel eventpolicy (the suspended reporting policy that included root cause analysis), thesentinel event alert and other newletters and educational products. Its Office ofQuality Management also tracks other quality problems and complaints, andparticipates in legislative and coalition work to reduce medical error. clxxiv




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National Patient Safety Foundation - 1997

The National Patient Safety Foundation was established in 1997 by the AmericanMedical Association, CAN HealthPro and 3M. In 1998 the mission of theFoundation was amended to “to improve measurably patient safety in the

delivery of health care” through a program that focuses on the systematizationand development of new knowledge around error prevention and public andprofessional advocacy to improve awareness of patient safety issues and supportfor their resolution.

It also sees an increasingly important role as a forum to connect researchers,professionals and the public to ensure uptake of research and appropriatedirection to researchers. More specifically activities include research grantcompetitions, awards for best practices in error reduction and communicationwith the public about safety, consensus programs, and educational conferencesand programs.

NPSF had a budget of $2.4 million in 2000.

Leapfrog Group

Comprised of more than 100 public and private organizations that provide healthcare benefits, the Leapfrog Group works with medical experts throughout theU.S. to identify problems and propose solutions that it believes will improvehospital systems that could break down and harm patients. The group focuses onurban area hospitals.

Approximately 32 million health care consumers in all 50 states are covered byLeapfrog employers who include: AT&T, Boeing, DaimlerChrysler, Delta Airlines,Exxon, Ford, General Motors, General Electric, General Mills, 3M, Proctor andGamble, and Xerox. They spend collectively US$53 billion on health benefits.

Leapfrog members use their purchasing power with health plans and health careproviders to reward institutions that meet specified standards. For example,

… purchasers will highlight a common set of discrete delivery system improvementslikely to yield the largest safety gains ("safety leaps"). These will be earmarked for specialvisibility in purchasers' interaction with providers, insurers/ administrators, andconsumers.

For example, purchasers will use common RFP questions to rate the implementationstatus of the safety leaps for their plans and providers and explicitly integrate such statusinformation into every method used to reward superior value (patient volume, price and/or

public recognition). With expert input, we identified three initial safety leaps, which havebeen transformed into the safety standards.

• Computer Physician Order Entry: Physician order entry in hospitals should becomputerized. Adverse drug events are the leading cause of avoidable death and




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disability in American hospitals. As documented in research by Dr. David Batesat Brigham and Women's Hospital, computer physician order entry (CPOE) is ahighly effective discrete remedy. In well-managed installations, its costs are likelyto be offset substantially by savings from the avoided costs of treatingcomplications.

•

Evidence-Based Hospital Referral: Elective treatment should be guided by providers to hospitals and clinical teams with superior outcomes, when validcomparative outcome measurement systems exist. Where outcome comparisonsdo not exist, such guidance should be based on scientific evidence of volume-outcome relationships. For many treatments, the scientific literature documentssignificantly superior patient outcomes in hospitals with higher volumes or withteaching programs

clxxv

Leapfrog researchers say if the three patient practices are implemented by allnon-rural hospitals in the country, 522,000 medical errors a year could beeliminated and 58,300 lives could be saved.

There is controversy about some of Leapfrog’s policies. The American Hospital Association

While the Leapfrog Group's goals are laudable, its approach oversimplifies the complextask of improving quality and suggests that a uniform solution will work for every hospitalin every community. CPOE, in particular, is not a simple solution. Implementation costsfor this customized technology range from $1 million to $20 million per hospital, and that'snot counting the significant yearly maintenance and training costs.

clxxvi

There is further discussion of Leapfrog in the section below on “Assessments ofPatient Safety Initiatives”.

MedWatch

The U.S. drug and medical device adverse event reporting program isMedWatch:

MedWatch, the FDA Safety Information and Adverse Event Reporting Program, servesboth health care professionals and the medical product-using public. We provideimportant and timely clinical information about safety issues involving medical products,including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and, special nutritional products (e.g., medical foods, dietarysupplements and infant formulas). Medical product safety alerts, recalls, withdrawals, andimportant labeling changes that may affect the health of all Americans are quicklydisseminated to the medical community and the general public via this web site.




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Institute for Safe Medication Practices

The ISMP works with health care practitioners and institutions, regulatoryagencies, professional organizations and the pharmaceutical industry:

ISMP provides an independent review of medication errors that have been voluntarilysubmitted by practitioners to a national Medication Errors Reporting Program (MERP)operated by the United States Pharmacopeia (USP) in the USA. Information from thereports may be used by USP to impact on drug standards. All information derived fromthe MERP is shared with the U.S. Food and Drug Administration and pharmaceuticalcompanies whose products are mentioned in reports.

clxxvii

ISMP focuses its efforts on improvements in medication labelling distribution, andother delivery characteristics. It also participates in collaborative exercisesaround patient safety and sponsors forums and other educational activities. It is anon-profit organization and has a national advisory board of practitioners toassist in problem solving.

ISMP is also a key player in much of the American Hospital Association’s effortsto improve patient safety. The AHA website points out that:

In November 1999, the AHA Board of Trustees made improving patient safety a priorityand targeted medication safety as its first objective. When the Institute of Medicinereleased its "To Err is Human" report in December 1999 that shined the national spotlighton medical errors, the nation’s hospitals earned high marks for our openness and for the

progress we are making. Why? Because it is an issue of critical importance to hospitalsand the people and communities we serve. It goes to the heart of public trust andconfidence, both vital to our future.

To provide expertise and leadership to these efforts, the AHA has formed a relationshipwith the Institute for Safe Medication Practices, the foremost authority on medicationsafety practices in hospitals and health systems. AHA is also working closely with theMassachusetts Hospital Association and Massachusetts Coalition for the Prevention ofMedical Errors, two organizations that have been leaders in the patient safety movement,as well as other state, regional, and metropolitan hospital associations.

clxxviii

AHA’s other work has been to ensure that hospitals have a voice in thedevelopment of policy around patient safety.




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National Quality Forum

The National Quality Forum was launched by the federal government at thesame time as Quality Interagency Council with the mandate to reduce error inprivate sector health care organizations. It is also a private sector body and will

work to promulgate “standard quality measurement tools to help all purchasers,providers, and consumers of health care better evaluate and ensure the deliveryof quality services.” clxxix

The Forum’s major goals are to:

1. Ensure system-wide capacity to evaluate and report on the quality of care2. Promote and inform consumer choice and further consumer understanding and use of

quality measures3. Enable providers to use data to improve performance4. Allow meaningful quality comparisons of health care providers and plans5. Promote competition on the quality of health care services

6. Use broad representation to marshal market forces for quality7. Reduce the burdens on providers and health plans by enabling them to collect consistentdata that avoids duplication.”

Its major stated tasks are:

1. Develop a framework based on national aims to coordinate and promote qualitymeasurement and reporting

2. Develop a comprehensive plan for implementing quality measurement, data collectionand reporting standards in the public domain to ensure the availability of comparativeinformation on the quality of care that will be furnished by all sectors of the health careindustry, including all payers, and widely reported to the public

3. Identify and endorse, on a periodic basis, core sets of quality performance and consumer protection measures to meet the common information needs of purchasers, consumers, providers, plans, quality oversight organizations, federal and state policy makers, and public health officials

4. Promote standardized measurement specifications, collection, verification and audit tools,and analytical tools for quality measurement and establish an effective education andcommunication plan for use by all stakeholders

5. Plan and promote analysis, use, and dissemination of quality information in a manner thatis accessible to the public to enhance consumer choice and quality improvement, and tofoster public understanding and use of quality information. Public reporting will be theresponsibility of national, regional, and local organizations. The Quality Forum will not bethe vehicle to release quality data or results of quality measurement analyses

6. Convene key organizations involved in developing quality performance measures [e.g., AHCPR, AHQA, AMA, ANA, FACCT, HCFA, JCAHO, NCQA] to coordinate andrationalize measures development

7. Assess adoption of quality reporting

8. Set a research and development agenda, including definition of priorities for health careimprovement and measurement




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9. Encourage development of health information systems and technology to support qualitymeasurement, reporting, and improvement.

clxxx

It recently released reports on error and minorities and several sets ofperformance measurement indicators. In many cases, the efforts of the Forumare as much directed towards performance measurement as towards error

specifically.

Patient Safety Institute (PSI)

PSI is a non-profit, collaborative and voluntary initiative with the goals ofimproving care and lowering health care costs by using technology to enhancepatient-provider relationships. PSI reflects the integration of distributed networksmanagement theory with the culture of safety work. It is independent of otherorganizations concerned with patient safety. The PSI initiatives focus on thedevelopment of low-cost information technology-driven solutions to patient safety

problems. Its web-site notes:

PSI is developing a communications network based on existing technology that providesreal-time, secure, patient-centric clinical information in five key areas that physiciansagree are critical for delivering quality care: diagnoses, laboratory results, medications,allergies and immunizations…PSI will offer access to the system through publiclyavailable, open-standard technology.

clxxxi

The PSI is supported by several leading, publicly traded information technologycompanies that have substantial commercial interests in the development ofweb-based secure data transfer systems. PSI currently has demonstrationprojects and is in the process of building its board and advisory committees.




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STATE INITIATIVES

A number of initiatives have been launched at the state level. These initiativesgenerally focus on the coordination or organization of existing quality

improvement efforts by providers, professional associations, and patient groups. A small number of initiatives seek specifically to promote a culture of safety byreducing the risk of civil disclosure or promoting a systems approach to reducingerror. A selection of these initiatives is described below.

California

A good example of the adoption of the patient safety agenda and coordination ofquality improvement activities is the California Institute for Health SystemsPerformance:

The California Institute for Health Systems Performance (CIHSP) is a non-profit, publicbenefit corporation charged with expanding the field of performance measurementthrough the establishment of comprehensive, standardized health care measurementsystems. CIHSP is dedicated to the improvement of the health of all Californians byestablishing measurement systems that are reliable, consensus-driven, collaborative,quality-focused and cost-efficient, and increase the accountability of the provider

community. clxxxii

The California Healthcare Foundation has been working on quality initiatives for anumber of years and has added patient safety to the list of issues it isaddressing. It has produced “A Practical Tool Kit for addressing medicationerrors’ that ‘hospitals can use when considering how best to proceed in choosing

and applying a variety of technological solutions, including CPOE, to preventmedication errors in the hospital setting”. clxxxiii

It has also produced a primer on physician order entry that “provides an overviewon computerized physician order entry (CPOE) systems, which have been shownto reduce medical errors and contain costs. The report describes how CPOEsystems work, discusses key features of the systems and the installationprocess, and provides case studies of hospitals that have implemented CPOE.”clxxxiv

Massachusetts

The Massachusetts Coalition for the Prevention of Medical Errors was established in1998 to develop a campaign in the Commonwealth to improve patient safety and reducemedical errors. A mission statement, structure, and process have been developed and 21organizations have confirmed their commitment to the coalition’s mission and goals. Thegoals of the Coalition are to disseminate knowledge and information about the causes ofsentinel events and develop strategies for prevention. The Coalition plans to driveimprovement by making this information available to health professionals and health care




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institutions for use in their own quality improvement programs through a statewidecampaign. This initiative seeks to strengthen the public’s trust and confidence in thehealth care delivery system as well, by increasing awareness of error preventionstrategies through public and professional education. Additional objectives include

providing a forum to promote collaboration among organizations with the common goalsof improving care and stimulating a coordinated series of spin-off projects. The formationof the Coalition was a response to the increased focus on medical errors … The evolutionof the Coalition is a dynamic and continually changing process. clxxxv

The coalition’s stated goals are of interest because they represent one state’sefforts to develop specific, targeted partnerships. Its stated goals are:

Establish a mechanism to identify and implement best practices to minimize medicalerrors; increase awareness of error prevention strategies through public and professionaleducation; and identify areas of mutual interest and minimize duplication of regulatoryand Joint Commission for the Accreditation of Healthcare Organizations (JCAHO)requirements so that efforts are focused on initiatives that can best improve patient care.

Like many organizations its efforts do focus on the identification andpromulgation of best practices, but it has also worked in specific and relativelyunder-addressed areas such as restraint use and ambulatory care. It has alsoworked towards clear statements around the relationship between institutionaland system accountability and patient safety.

Minnesota

The Minnesota Alliance for Patient Safety provides another example of anumbrella organization. It was founded in 2000 as “a partnership among theMinnesota Hospital and Healthcare Partnership, Minnesota Medical Association,

Minnesota Department of Health and more than 50 other public-private healthcare organizations working together to improve patient safety.” clxxxvi It has anumber of standing sub-committees that are addressing critical issues aroundpatient safety programs and legislation including committees on communicationand education, best practices, data privacy and measurement. The Alliance alsouses member input and analysis to respond to legislative activities.

Pennsylvania

Pennsylvania recently established of a patient safety collaborative:

The Pennsylvania Patient Safety Collaborative (PPSC) was formed by 26 statewideorganizations with the goal of reducing patient injury from medical error. Theseorganizations include representatives from government, consumers, labor, business,insurers, providers and practitioners Through education, sharing of effective safety

practices and disseminating resources to aid health care organizations improve patientsafety, the PPSC is working to make patient safety a top priority for all stakeholdersacross the Commonwealth who influence patient care .clxxxvii




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The collaborative has identified three areas of work focused on best practices,cultural change, and communications and supported this work with focusgroups/expert panels and the development of a website and communicationsstrategy including conferences.

The collaborative has been very successful in involving hospitals in its work:

An ongoing inventory of safety practices of Pennsylvania healthcare organizations hasbeen conducted with the support of the Pennsylvania peer review organization.Responses have been received from over 70 hospitals outlining 108 safety practices. Thebest of these will be communicated to the provider community through a series ofregional forums and through the publication of a safe practices compendium. Eventually,this work will be extended to all Pennsylvania healthcare organizations including long-term care, physician practices and retail pharmacies.

The collaborative has also developed and published a monograph on thedevelopment of a culture of safety. clxxxviii

Rhode Island

Rhode Islands’ recently formed Quality Institute was originally formed inresponse to the proposed merger of health plans. The Institute now workstowards the improvement of a variety of dimensions of quality including, but notlimited to, patient safety:

Rhode Island Attorney General Sheldon Whitehouse has announced the launching ofThe Rhode Island Quality Institute, which will promote coordination and collaborativerelationships, with the intent to make health care safer, reduce waste, and rework thehealth care system and its incentives for Rhode Island residents. … the Quality Institute

is comprised of hospitals, physicians, nurses, business leaders, insurance companiesand governmental representatives. At the Whitehouse's direction, the participants haveworked to identify key areas of health care that will lead to safer and more cost effectivemedical care in the state.

clxxxix

Texas

Texas’ largest provider organizations have formed a patient safety alliance:

Texas's four major health care associations have formed the Texas Patient Safety Alliance (TPSA) in a move to promote a safe patient experience for all Texas residents. Announced March 8, 2002 members of the TPSA are the Texas Hospital Association, the

Texas Nurses Association, the Texas Medical Association and the Texas PharmacyCongress. TPSA Chair John Holcomb, M.D., a pulmonary specialist in San Antonio, saidthat patient safety is a systemic issue involving hospitals, physicians, nurses, and

pharmacists. He said the group's goal is to develop practical approaches to make patients' health care as safe and effective as possible. Holcomb said since there are nofunded mandates to address the problems, TPSA's only incentive is to do the right thingfor patients and to eliminate preventable medical errors.

cxc




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Wisconsin

The Madison Patient Safety Collaborative provides an example of local levelcoordination. Its website notes that, ‘The Madison Patient Safety Collaborative'sprimary mission is to provide a structure for area healthcare providers to work

collaboratively to develop, share and implement patient safety solutions withinthe community.”

Its most recent activities were summarized as:

The collaborative's most mature initiative focuses on eliminating the use of error-proneabbreviations in prescription drug orders. In June 2001, the MPSC established aworkgroup charged with reducing patient falls. Members will design, implement andevaluate a common, targeted intervention designed to prevent the occurrence andharmful outcomes of patient falls. In an effort to involve and inform consumers, theMPSC has also created an educational brochure for consumers regarding safemedication use in various health care locations and the home. cxci

Virginia

Virginians Improving Patient Care and Safety is a coalition of almost 50 publicand private organizations:

Virginians Improving Patient Care and Safety, a coalition of hospitals, health care professionals and health plans, is working together to make the Virginia health caresystem safer for patients and the public. You can help too. The single most important wayyou can help to prevent errors is to be an active member of your health care team. Thatmeans taking part in every decision about your health care. Research shows that patientswho are more involved with their care tend to get better results.

cxcii

This group has produced a book entitled BE INVOLVED IN YOUR HEALTHCARE. Tips to Help Prevent Medical Errors. cxciii

The Virginia experience also brings an example of specific legislation to supportsharing of data around patient safety (Senate Bill 316) that increases protectionfrom civil disclosure for activities involving analysis of patient safety problems.cxciv




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Although patient safety is the second most important issue driving thedevelopment of the IT infrastructure necessary to support patient safety

improvements, the Health Insurance Portability and Accountability Act (HIPPA)will likely remain the driving force behind improvements in the IT infrastructure. Arecent Wall Street Journal article summarized the importance of patient safety,however, and stated:

Add to the mix the growing alarm about medical mistakes, especially those that mighteasily have been prevented with better data and backup from information systems. Sincethe 1999 Institute of Medicine report that 44,000 to 98,000 people die annually frommedical mistakes, concerns about patient safety have been mounting in the medicalcommunity and among legislators. Combined with recent horror stories about botchedclinical trials, efforts to fix the problems are finally gathering steam.

Several states have enacted legislation aimed at reducing medical error, and hospital-accreditation groups are moving to require evidence of new safety procedures as part ofthe licensing process. There has been talk of national legislation aimed at reducingmedical errors. And in hearings on Capitol Hill in recent months, a swarm of experts have

been called in to testify about how technology can help solve the problem such ascomputer systems that let doctors know if they've prescribed the wrong dosage of a drug.

"Hospital chief executives are totally clued in to the safety issue and how technology canhelp," says Mitch Morris, an oncologist who runs the clinical practice group at FirstConsulting Group in Dallas. "They understand this is something they have to payattention to and spend money on." cxcv

In general, however, error reporting initiatives by a number of the organizations

noted above and supported by the QuIC have agreed on a few key points. Thesecommon findings are:

• error reporting systems that are mandatory should be limited to seriouserrors

• error reporting systems that are voluntary may take in a number of othertypes of adverse events and near misses

• error reporting systems should be backed up by techniques such as rootcause analysis that allow organizations to identify the causes of thoseerrors

• error reporting system are focusing on hospital care

• error reporting systems should be matched to evaluations of techniquesand strategies to reduce error

• error reporting systems and subsequent analyses should not put providersat increased risk of civil prosecution, but these systems should not beallowed to hide negligence or criminal activity by providers.




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Public and Media Opinion

Commonwealth Fund Patient Survey

The Commonwealth Fund is a private foundation that supports independentresearch on health and social issues and makes grants to improve health carepractice and policy. In April 2002 it released the results of a survey of 6,722

Americans on health care quality issues. Questions about patient safety wereincluded:

Twenty-two percent of respondents reported that they or a family member hadexperienced a medical error of some kind. Ten percent reported that they or a familymember had gotten sicker as a result of a mistake at a doctor’s office or in the hospital,while 16% had been given the wrong medication or wrong dose when filling a prescriptionat a pharmacy or while hospitalized. About one-third (33%) of those reporting aprescription error said it occurred while hospitalized.

About half (51%) of those experiencing an error at a doctor’s office or hospital reportedthat the problem was very serious, while 22% of those experiencing a medication errorreported that the error turned out to be a very serious problem.

Nationally, these reports translate into an estimated 22.8 million people with a least onefamily member… who experienced a mistake in a doctor’s office or hospital or were giventhe wrong medication or dose. Based on an evaluation of these errors, an estimated 8.1million households reported the error to be a very serious problem.cxcvi

The authors speculate based on the survey results that the Institute ofMedicine’s estimate of 44,0000 to 98,000 deaths from adverse events in the U.S.

“may only be the tip of the iceberg”.

Pushing the profession: how the news media turned patient safety into a priority

A recent article in the journal Quality and Safety in Health Care, “Pushing theprofession: how the news media turned patient safety into a priority” cxcvii analysed media involvement in patient safety issues. The U.S. media did twothings that contributed to making patient safety a major public policy issue: first,major media such as National Public Radio, the Boston Globe, New Yorker,Philadelphia Inquirer, CBS ran exposes of medical errors that put a human face

on the victims and revealed patterns of errors; and second, they used dramaticimagery to illustrate the scope of the problem - “Two 747s crashing every threedays”.

The media also extensively covered the release of To Err is Human andsubsequent follow-up reports.




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Malpractice Insurance

The link between malpractice insurance and patient safety is, of course, thatsome of the malpractice actions stem from medical errors. The rising costs ofmalpractice might be reversed in part by effective patient safety programs. Like

Australia, the United States is in the midst of a medical malpractice coveragecrisis. Costs are rising so dramatically that insurers are leaving the medicalmalpractice field, remaining companies are dramatically increasing premiums,and Congress and state legislatures are struggling to find a legislative solution.

Although this situation has been chronic for some time, it now seems to bereaching an acute point.

Insurers Leaving the Field

St. Paul – the United States’ and the world’s largest malpractice insurance carrier- is exiting the medical malpractice business on a global basis through non-renewal upon policy expiration. The company is forecasting that medicalmalpractice will generate a 2001 underwriting loss of approximately US$940million. St. Paul’s 2001 premiums for medical malpractice were approximately$530 million. cxcviii According to the American Hospital Association, insurancecarriers are leaving the liability insurance business in large numbers, leavingphysicians without the ability to obtain coverage. cxcix

Claim Costs According to a study by the Stanford Consulting Group, the national average

claims cost for physicians involved in malpractice cases is $248,947. cc

Rising Premiums for Physicians and HospitalsMedical malpractice claims for New Jersey hospitals jumped 250% over the pastthree years. The average hospital saw its premiums increase from US$373,328in 1999 to US$942,539 in 2002. Physician liability premiums can reachUS$94,000 and higher. Medical liability premiums in Ohio have increased bymore than 100% in many areas.The growing premiums are causing doctors to leave their practices, stopperforming high-risk procedures, retire early or move in search of lowerinsurance rates. cci

Tort Reform LegislationIn April 2002 a bill - the Help Efficient Accessible, Low-cost Timely Health Care

Act (HEALTH) - was introduced in Congress. It is designed to curb medicalliability insurance premiums and punitive jury awards. The Act would:

• place a $250,000 limit on non-economic damages• limit plaintiff attorney contingency fees




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• limit the statute of limitations• base damage awards on culpability

However, some congressmen are concerned that even with tort reform, there isno guarantee that high premiums would decrease.

The Pennsylvania General Assembly has approved medical liability insurancereform legislation. Among other things, the legislation reduces the amount thathospitals and other providers must pay for malpractice insurance and makeschanges to when patients can sue, such as placing a four-year statute oflimitation on most suits.

Federal Government Position

In July 2002 the U.S. Department of Health and Human Services publishedConfronting the New Health Care Crisis: Improving Health Care Quality and

Lowering Costs by Fixing our Medical Liability System. It states that “problemshave reached crisis proportions” and notes the relationship with incidentreporting:

Excessive litigation is impeding efforts to improve quality of care. Hospitals, doctors, andnurses are reluctant to report problems and participate in joint efforts to improve carebecause they fear being dragged into lawsuits, even if they did nothing wrong.

ccii

The federal government estimates that malpractice coverage and defensivemedicine costs the government between $28.6 billion and $47.5 billion annually,and that this could be reduced by $25.3 and $44.3 billion if “reasonable limits”were placed on non-economic damages. It points out that the average award

rose 76% between 1996 and 1999. cciii

The report states, “The friction generated by operating the system takes most ofthe money… 72% is spent on legal, administrative, and related costs”. cciv

The President has endorsed the following “proven steps”:

• Improve the ability of all patients who are injured by negligence to get quicker, unlimitedcompensation for their “economic losses”, including the loss of the ability to providevaluable unpaid services like care for children or a parent

• Ensure that recoveries for non-economic damages could not exceed a reasonableamount ($250,000)

• Reserve punitive damages for cases that justify them—where there is clear andconvincing proof that the defendant acted with malicious intent or deliberately failed toavoid unnecessary injury to the patient—and avoid unreasonable awards (anything inexcess of the greater of two times economic damages or $250,000)

• Provide for payment of judgement over time rather than in one lump sum—and thusensure that the money is there for the injured patient when needed

• Ensure that old cases cannot be brought years after an event when medical standardsmay have changes or witnesses’ memories have faded, by providing that a case may not




149

be brought more than three years following the date of injury or one year after theclaimant discovers or, with reasonable diligence, should have discovered the injury

• Informing the jury if a plaintiff also has another source of payment for the injury, such ashealth insurance

• Provide that defendants pay any judgement in proportion to their fault, not on the bsis ofhow deep their pockets are

ccv

Qualified Privilege

Patient Safety and Quality Improvement Act

On June 5, 2002 the Patient Safety and Quality Improvement Act aimed at“reducing medical errors and providing legal protections for information submittedvoluntarily to patient safety improvement systems” ccvi was introduced inCongress.

The Act would also:

• Recognize the Agency for Healthcare Research and Quality as the leaderin patient safety for funding research and for dissemination of informationlearned about improving patient safety

• Recognize that there are many patient safety initiatives under way in the public and private sectors in which operational expertise is beingdeveloped

• Recognize that to be effective, these systems must have the buy-in, trustand cooperation of the health care providers ccvii

The American Hospital Association believes that the bill would create a safeenvironment supporting candid discussion of errors, and encourages caregiversto share medical error information voluntarily.

Apparently the bill has the support of the Bush administration. Health and HumanServices Secretary Tommy Thompson is quoted as saying that “the tri-partisanbill builds upon the administration's commitment to patient safety”. ccviii Acompanion bill has been introduced in the House of Representatives.




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ASSESSMENTS OF PATIENT SAFETY INITIATIVES

Making Health Care Safer

A Critical Analysis of Patient Safety Practices - 2001This report by the Agency for Healthcare Research and Quality reported on aproject aimed at collecting and reviewing “the existing evidence on practicesrelevant to improving patient safety”. ccix

The report notes:

Readers familiar with the state of evidence regarding quality improvementin areas of health care where this has been a research priority (e.g.cardiovascular care) may be surprised and even disappointed, by the

paucity of high quality evidence in other areas of health care for many

patient safety practices. One reason for this is the relative youth of thefield. ccx

The report also enumerates the difficulties in evaluating patient safety measures:

• Many practices (e.g., the presence of computerized physician order entry systems,modifying nurse staffing levels) cannot be the subject of double-blind studies becausetheir use is evident to the participants.

• Second, capturing all relevant outcomes, including "near misses"(such as a nursecatching an excessive dosage of a drug just before it is administered to a patient) andactual harm, is often very difficult.

• Third, many effective practices are multidimensional, and sorting out precisely which partof the intervention works is often quite challenging.

• Fourth, many of the patient safety problems that generate the most concern (wrong-sitesurgery, for example) are uncommon enough that demonstrating the success of a "safety

practice" in a statistically meaningful manner with respect to outcomes is all butimpossible.

• Finally, establishing firm epidemiologic links between presumed (and accepted) causesand adverse events is critical, and frequently difficult.

ccxi

The authors of this study – academics at Stanford and the University of CaliforniaSan Francisco – reviewed 79 practices and rated them in terms of evidence to

support more widespread implementation. The list below is in rank order:

1. Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk.

2. Use of perioperative beta-blockers in appropriate patients to prevent perioperativemorbidity and mortality.

3. Use of maximum sterile barriers while placing central intravenous catheters to preventinfections.




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4. Appropriate use of antibiotic prophylaxis in surgical patients to prevent perioperativeinfections.

5. Asking that patients recall and restate what they have been told during the informedconsent process.

6. Continuous aspiration of subglottic secretions (CASS) to prevent ventilator-associated pneumonia.

7. Use of pressure relieving bedding materials to prevent pressure ulcers.

8. Use of real-time ultrasound guidance during central line insertion to preventcomplications.

9. Patient self-management for warfarin (Coumadin™) to achieve appropriate outpatientanticoagulation and prevent complications.

10. Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition incritically ill and surgical patients.

11. Use of antibiotic-impregnated central venous catheters to prevent catheter-relatedinfections.

ccxii

In its conclusion, the authors note that “… this review seeks to plant a seed forfuture implementation and research by organizing and evaluating the relevantliterature”. ccxiii

The Challenge of Assessing Patient Safety in America’s Hospitals - 2002

This hospital-funded study set out to define criteria for standards patient safetymeasures. It appears to be a response to the Leapfrog Group’s incentives relatedto specified patient safety measures. According to the authors,

At a time when health care costs are escalating, it is important to recognize that the

human and capital resource investment necessary to establish or reform systems is verysignificant. Thus, consideration must be given to the complexity and diversity of U.S.hospitals when establishing standards of care to ensure resources are used wisely tobenefit patient safety and quality. Criteria for assessing patient safety would help guidethe evaluation of initiatives suggested as potential standards for promoting quality andsafety in America’s health care system.

ccxiv

The figure below outlines the criteria for standards:




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Source: The Challenge of Assessing Patient Safety in America’s Hospitals, p. 6

The authors then applied these criteria to 97 safe practices reviewed by theUCSF-Stanford group that produced Making Health Care Safer. The resultsproduced below overlap some of the Leapfrog Group’s recommended measures.

Source: The Challenge of Assessing Patient Safety in America’s Hospitals, p. 12




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One point of disagreement between Leapfrog and the American Hospital Association is the former’s emphasis on urban hospitals and the latter’s positionthat standards should be applicable to all hospitals. The authors’ note:

Although the promise of incentives for hospitals that can successfully implement patientsafety programs is certainly an important step toward building better collaboration

between purchasers of health care and America’s hospitals, the immediate resourcesthat may be required for some initiatives may be prohibitive for many hospitals, thus

precluding the promise of such collaboration.ccxv




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GAPS

Hospital Focus

As in Australia, patient safety programs focus almost entirely on hospitals andother institutions. There appears to be little happening regarding drug safety(outside hospitals) or community health care services. Current taxonomies focuson institution-based care.

Reporting is Largely Voluntary

Current approach to reporting is to support limited state-based mandatoryreporting systems. Common elements may make it possible to integrate data in aconsistent fashion for certain types of error, but multiple issues around type,format, and organization of reporting systems remain to be resolved.

Lack of Overall Coordination

No coordinating body for public, professional, and private patient safety issues.Norton has pointed out appropriately that patient safety initiatives represent newefforts, the integration or combination of older efforts, and repackaging of olderefforts. In this case, true integration of activities may be impossible, but there aresome differences emerging in recommendations, even from organizations likeIOM and federal government.

Commission But Not Omission

Errors of omission focus have received attention in the literature and attentionfrom Medicare, but relatively little attention in terms of documenting orpromulgating best practices.

Self-Identified Gaps

U.S. experts have identified the following gaps:

• definition of common set of measurements for patient safety

• identification of most effective way to communicate information on patientsafety to public

• identification of barriers to mandatory and voluntary reporting (includingevaluation of existing reporting systems)

• resolution of state-federal jurisdiction issues




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• development of consistent federal response - e.g. across transfer paymentorganizations, for example those receiving Medicare, and acrossgovernment facilities such as VA hospitals

FUTURE PLANS

AHRQ Patient Safety Program Evaluation Center

Recently the Agency for Healthcare Research and Quality and Research issueda RFP to establish a patient safety program evaluation center. The mandate ofthe center is to:

1. Develop and implement an overall evaluation plan for patient safety projects funded by AHRQ consistent with Agency requirements, GPRA (Government Performance Results

Act) requirements, initiative intents, and Congressional mandates.2. Develop baseline patient safety evaluation measures for determining context and

antecedent conditions existing prior to initiation or at the beginning of implementation of AHRQ's patient safety research initiative.

3. Utilize formative evaluation procedures, monitor progress at meeting initiative intents andobjects and make recommendations for improvement.

4. Assess overall initiative impacts, outcomes, and adoption diffusion using both qualitativeand quantitative assessment approaches.

5. Document and prepare evaluation reports to various audiences and stakeholdersindicating the results of AHRQ's funded patient safety research and project activities.

ccxvi

The RFP closed on June 7, 2002.




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ENDNOTES

i The Australian Health Care System: an outline. Commonwealth Department of Health and Aged Care,

September 2000.ii W.B. Runciman, Iatrogenic injury in Australia: a report prepared for the Australian Patient Safety

Foundation. October 2001, p.2iii Review of Professional Indemnity Arrangements for Health Care Professionals, Compensation and

Professional Indemnity in Health Care: Final Report . November 1995, Australian Government Publishing

Service. Canberra, p.26iv Commonwealth Department of Health and Family Services, Task Force on Quality in Australian Health

Care: Final Report ,v National Expert Advisory Group on Safety and Quality in Australian Health Care: Interim Report. April1998.vi National Expert Advisory Group on Safety and Quality and Australian Health Care, Implementing safety

and quality and enhancement in health care: National actions to support quality and safety improvement in

Australian health care. July 1999.vii Ibid, p. iviii Ibid, p. vix

Commonwealth Department of Health and Aged Care, Australia: Selected Health Care Delivery and Financing Statistics – September 2000, p. 4.x Commonwealth of Australia, Australian Health Care Agreement with State of New South Wales,

paragraph 29, p.9.xi Commonwealth of Australia, Australian Health Care Agreement with State of New South Wales,

paragraph 29, p.9.clause 29xii "A Framework for Health Care Safety and Quality Improvement Issues Best Dealt With at the National

Level", Australian Health Care Agreements: Annual Performance Report 1998-99, pp. 135-6xiii Australian Capital Territory Government, Quality First: a commitment to quality and safety and act

health services. p. 5xiv Australian Health Care Agreements: Annual Performance Report 1998-99, p. 135-6xv Safety and Quality Council, Action Plan 2001,p. 31xvi Commonwealth of Australia, Budget 2001-2002, Health Fact Sheet 6: Safer health care xvii Safety and Quality Council, Action Plan 2001, p. 4xviii Ibid, p. pp. 5-7xix Safety and Quality Council, Core Standards for Health Care Safety – Consultation Paper , August 2001,

p. 5.xx Ibid, p.5xxi Safety and Quality Council, A Draft Model for Medical Registration August 2001, p. 6. xxii Ibid, p. 6.xxiii Ibid, pages 7 and 9-10xxiv Safety and Quality Council, Credentials and Clinical Privileges Guidelines: Working Draft for

Consultation, August 2001, p. 2.xxv Commonwealth Department of Health and Aged Care, The Quality of Australian Health Care: Current

Issues and Future Directions. Occasional Papers: Health Financing Series, Volume 6. 2000xxvi Ibid, p. 4xxvii Ibid, p. 39xxviii Ibid, p.41xxix National Institute of Clinical Studies, Strategic Plan 2001 -- 2004, p.1xxx Ibid, p.8xxxi www.health.nsw.gov.au/quality/macqhc.htmlxxxii Ibidxxxiii www.health.nsw.gov.au/quality/wp/safety.htmlxxxiv A Framework for Managing the Quality of Health Services in New South Wales. NSW Health, p. 2




157

xxxv Ibid, pp.14-15xxxvi Ibid, p. 17xxxvii www.health.nsw.gov.au/quality/history.htmlxxxviii NSW Health. Quality of Healthcare Indicators Set: Definitions. November 2000xxxix Victorian Department of Human Services, Clinical Risk Management Strategy 2001 xl

www.qualitycouncil.health.vic.gov.au/termsref.htmxli Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.17xlii http://clinicalrisk.health.vic.gov.au/report.htmxliii Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.12xliv Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.16xlv http://clinicalrisk.health.vic.gov.au/limit.htmxlvi Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.9xlvii Ibid, p. 10xlviii Queensland Health , Strategic Plan for Quality: Quality Improvement and Enhancement Program:

1999-2004. Revised Edition October 2000xlix Ibid, p.6l Health Department of Western Australia, Strategic Quality Plan Western Australia 1998 8/99 - 2002/3,

pages not numberedli Metropolitan Health Services - Annual Report 2000/2001, p.42lii Ibid, p.42liii

Enduring Solutions, A Patient Safety Plan for the ACT . February 1999, p. vliv Australian Capital Territory Government, Quality First: a commitment to quality and safety and act

health services. p. 25lv Runciman, op.cit., 3lvi Safety and Quality Council , Safety In Numbers: A Technical Options Paper for a National Approach tothe Use of Data for Safer Health Care., p. 4lvii Ibid, pp, 5-7lviii Australian Broadcasting Corp., Lateline program, April 30th 2002 lix Commonwealth Department of Health and Aging, The Commonwealth Qualified Privilege Scheme, p.2lx Safety and Quality Council, The Public Interest in Health Care Qualified Privilege: Issues Paper , August

2001, p. 17.lxi Ibid, p. 14.

lxii Review of Professional Indemnity Arrangements for Health Care Professionals, Compensation and Professional Indemnity in Health Care: Final Report . November 1995, Australian Government Publishing

Service. Canberra, p. 2lxiii

Ibid, p. 26lxiv Ibid, p. xivlxv Ibid, p. xviilxvi Law Reform Committee, Victoria Parliament, Legal Liability of Health Service Providers lxvii Sydney Morning Herald, "Insurer pays out 96 million as patient complaints soar". November 23, 2000lxviii Press release, Commonwealth Minister for Revenue, April 30, 2002.lxix Communique: Ministerial Meeting on Medical Indemnity, April 23, 2002lxx Ibidlxxi ABC News Online, Panel to review liability, medical indemnity, July 3, 2002.lxxii op. cit., p. 6lxxiii

NSW Health Complaints Commission, The Complaints Process, p. 8.lxxiv Ibid, p. 11.lxxv Runciman, op. cit.lxxvi Safety and Quality Council, Safety In Practice. P. 17lxxvii Safety and Quality Council, Core Standards for Health Care, p. 3lxxviii

Oonagh Gay, Devolution and Concordats. House of Commons Library Research Paper 99/84. October1999, pp. 2-10lxxix www.nhs.uk/thenhsexplainedlxxx Pocket World in Figures, 2002 Edition. The Economist, p. 223




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lxxxi www.nhs.uk/thenhsexplainedlxxxii Department of Health, Supporting doctors, protecting patients – A consultation paper on preventing,recognizing, and dealing with poor performance of doctors in the NHS in England: Executive Summary, p.

1lxxxiii Ibid, p. 2lxxxiv

Ibid, p.5lxxxv Department of Health, An organization was a memory: report of an expert group on learning from

adverse events in the national health service chaired by the Chief Medical Officer , 2000, p.6lxxxvi Ibid, p.5lxxxvii Ibid, pp. vii-viiilxxxviii Ibid, p. 21lxxxix Ibid, p. 35xc Ibid, p. 35xci Ibid, p.37xcii Ibid, p.46xciii Ibid, p.54xciv Ibid, p.70xcv Ibid, pp. 80-86xcvi National Health Service, Assuring the Quality of Medical Practice: Implementing Supporting doctors

protecting patients, pp. 28-29xcvii

Department of Health, Building a safer NHS for patients: Implementing an organization with amemory, p. 9xcviii National Health Service, Appraisal for consultants working in the NHS , April 2001, p.3.xcix National Audit Office, Handling clinical negligence claims in England , May 2001, pp. 1-3c National Health Service, A Commitment to Quality, a Quest for Excellence. June 2001, p. 7ci op. cit, p.1cii BRI Inquiry: Final Report, p. 2ciii Ibid, p. 4civ Ibid, p.2cv Ibid, p. 11cvi Ibid, p.16cvii Ibid, pp. 450-451

cviii Ibid, p. 442cix Department of Health, Learning from Bristol: The Department of Health's Response to the Report of the

Public Inquiry into children's heart surgery at the Bristol Royal Infirmary 1984 - 1995, 2002, p. 13cx

Ibid. p. 4cxi Building a safer NHS for patients, p. 45cxii p. 46cxiii Department of Health, Shifting the Balance of Power, The Next Steps, p. 44cxiv www.doh.gov.uk/clinicalgovernancecxv Nigel Starey, What is clinical governance? Hayward Medical Communications, p.2cxvi www.chi.nhs.uk/ eng/about/what.shtmlcxvii www.chi.nhs.uk/eng/inv/index.shtmlcxviii www.chi.nhs.uk/eng/cgr/assessing.shtmlcxix CHI, Combined Annual Report and Accounts, 2000-2001, p.25cxx

www.nice.org.ukcxxi Ibidcxxii Ibidcxxiii A First Class Service, Setting quality standards, paragraph 2.34cxxiv www.doh.gov.uk/nsf/about.htmcxxv

NHS Litigation Service, CNST Clinical Risk Management Standards, June 2000cxxvi National Health Service, Appraisal for consultants working in the NHS , p.5cxxvii Ibidcxxviii www.doh.gov.uk/gpappraisal




159

cxxix www.ncaa.nhs.ukcxxx NCAA, Corporate Plan 2002-2005, pp. 16-17cxxxi NCAA, Business Plan 2002-03, p. 25cxxxii www.npsa.org.uk/cxxxiii op. cit., p. 59cxxxiv

www.carestandards.org.uk/cxxxv p. 42cxxxvi Department of Health & National Patient Safety Agency , Doing Less Harm: Improving the safety and

quality of care through reporting, analysing and learning from adverse incidents involving NHA patients –

Key requirements for health care providers, pp. 7-8cxxxvii Ibid, pp. 9-10cxxxviii Ibid, p. 33cxxxix Ibid, p. 42cxl Ibid, p. 28cxli National Patient Safety Agency, Pilot Project Evaluation Report , pp. 6-9cxlii Guardian Unlimited, 1m patients ‘suffer harm in NHS hospitals’ , June 19, 2002.cxliii www.avma.org.uk/cxliv Based on web archival search of these sourcescxlv Op. cit., p. 1cxlvi National Health Service Litigation Authority, Report and Accounts 2001, p. 4cxlvii

Op. cit., p. 451cxlviii Op. cit., p. 162cxlix www.doh.gov.uk/clinicalnegligencereform/cl David Batty, “Bid to cap NHS negligence payouts”, Guardian, August 28, 2001cli Gaby Hinsliff, “Patients ‘should not have right to sue’”, Guardian, January 13, 2002clii Op. cit., p. 142cliii NHS Complaints Procedure National Evaluation, pp. 3-4cliv Response to Bristol , p. 141clv National Health Service, Modernising Regulation in the Health Professions: Consultation Document ,

August 2001, p. 2clvi NPSA website FAQ pageclvii op. cit., p. 442

clviii Learning from Bristol , pp. 3 and 10clix Ibid, p. 3clx Ibid, p. 8 and www.doh.gov.uk/clinicalnegligencereform/clxi

Ibid, p. 5clxii Ibid, p. 12clxiii Ibid, p. 11clxiv www.revalidationuk.info/clxv National Audit Office, Handling clinical negligence claims in England , May 2001, p. 2.clxvi http://www.ahcpr.gov/news/press/pr2001/workrfapr.htm clxvii

See: http://www.ahcpr.gov/qual/errorsix.htm clxviii http://www.ahcpr.gov/about/cj2003/budbrf03.htmclxix AHRQ Focus on Research. AHRQ Pub. No. 02-MO21, March 2002clxx http://www.patientsafety.gov/

clxxi www.quic.gov/report/mederr2.htm clxxii

http://www.jcaho.org/accredited+organizations/long+term+care/sentinel+events/position+statements/index.

htm)clxxiii http://www.jcaho.org/about+us/news+letters/sentinel+event+alert/sea_26.htm clxxiv http://www.jcaho.org/accredited+organizations/patient+safety/index.htm clxxv www.leapfroggroup.org/purchase1.htm#Dclxxvi AHA Trustee, January 1, 2002clxxvii

http://www.ismp.org/Pages/about.html



clxxviii http://www.aha.org/medicationsafety/AHAinitiative.asp clxxix http://www.quic.gov/report/medderr2.htm clxxx http://www.qualityforum.org/mission/home.htm clxxxi http://www.ptsafety.org/ clxxxii http://www.cihsp.org/cgi-bin/efault.asp clxxxiii

http://www.chcf.org/topics/view.cfm?itemID=12682 clxxxiv http://www.chcf.org/topics/view.cfm?itemID=12542 clxxxv http://www.macoalition.org/ clxxxvi http://www.mnpatientsafety.org/about/index.htm clxxxvii http://www.haponline.org/quality/safety/papsc/)clxxxviii

http://www.haponline.org/quality/safety/papsc/elements/details.asp?ID=CW0hDUfO4DeP1Oa39bTa clxxxix http://www.riag.state.ri.us/press/Jun02/061002_RI%20Quality%20Institute%20Launched.htm cxc

http://www.healthforum.com/HFPubs/asp/Archive.asp cxci

http://www.madisonpatientsafety.org/about%20mpsc.htm cxcii http://www.vipcs.org/all_aboutus.htmcxciii

http://www.vipcs.org/patients/index.htm cxciv http://legis.state.va.us/jchc/SD24_2002.pdfcxcv Laura Landro, “Health Care Goes Digital: Doctors and hospitals find they can't stay offline any

longer , Wall Street Journal . June 10, 2002

cxcvi Karen Davis et al., Room for Improvement: Patients Report on the Quality of their Health Care. The

Commonwealth Fund, April 2002, pp. 3-4cxcvii M.L. Millenson, “Pushing the profession: how the news media turned patient safety into a priority.”

Quality and Safety in Health Care 2002; 11: 57-63cxcviii www2.stpaul.com/spc/corp/spcnews.nsf/cxcix AHA News Now, June 11, 2002cc Ibid, Junecci Ibid, June 11, 2002ccii U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and

Evaluation. Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Costs

by Fixing our Medical Liability System. Washington: July 24, 2002, p. 1cciii Ibid, p. 7cciv Ibid, p. 11

2002 Global Pat Safety Strategy

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