2002 gov patient securit e

36

APPENDIX AUSTRALIA��40 Background��.�..40 System of Government��.40 Description of Health Care System ��40 Intergovernmental Relations��.40 National Initiatives��42 Australian Patient Safety Foundation 1989��42 Review of Professional Indemnity Arrangements for Health Care Professionals 1991-95��42 Task Force on Quality in Australian Health Care 1995-96��..42 National 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��.��.46 Commonwealth Health Occasional Paper on Quality 2000��49 National Institute of Clinical Studies 2001��..50 State/Territorial Initiatives��..51 New South Wales��...51 Victoria��..56 Queensland��..61 Western Australia��64 Australian Capital Territory��65 Error Reporting Systems and Data Analysis��68 Australian Incident Monitoring System (AIMS)��..68 NSW Performance Indicators��...70 Victoria Clinical Incident Reporting��..70 Victoria Sentinel Event Reporting and Root Cause Analysis��..70 Queensland Incident Monitoring��..70 Western Australia Computerized Incident Management System��...70 ACT Adverse Event Incident Monitoring System��..70 Data Reporting and Analysis��71 Public and Media Opinion��..72 Australian Patient Safety Survey 2001��...72 Medical Error Action Group��...73 Former President, Australian Medical Association��73 The Australian Commentary��.73 Regulatory, Legal and Insurance Issues��75 Qualified Privilege��...75 Malpractice Insurance Issues��77 Role of Professional Governing Bodies��...80 Complaints Commissions��...80

37

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

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

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

Reports and Inquiries��.. 86 A First Class Service: Quality in the new NHS � 1997�..�� 86 Supporting doctors, protecting patients � 1999��.. 86 An organization with a memory � 2000�.��..� 87 Assuring the Quality of Medical Practice � 2001��.�� 90 Building a safer NHS for patients: Implementing an organization with a memory � 2001..��91 Appraisal for consultants working in the NHS � 2001�.�..��.. 91 Handling clinical negligence claims in England � 2001��91 A Commitment to Quality, a Quest for Excellence � 2001..��.92 Bristol Royal Infirmary Inquiry: Final Report � 2001��..��...92 Doing Less Harm: Improving the safety and quality of care through reporting, analyzing and learning from adverse incidents involving NHS patients � 2001�� 94 Learning from Bristol: The Department of Health's Response - 2002. ��. 94 National Initiatives. ��..��. 96 Error Elimination/Reduction Targets�..�� 96 NHS Clinical Governance � Duty of Quality��..�� 97 Commission for Health Improvement��.�..��98 National Institute for Clinical Excellence.��..100 National Service Frameworks..��..�� 100 Clinical Risk Management Standards�� 102 Annual Physician Appraisals�..��102 National Clinical Assessment Authority��...�� 103 National Patient Safety Agency..�� 104 National Care Standards Commission��.. 105 NHS Patient Safety Research Program��. 105 Error Reporting Systems and Data Analysis�..��106 An Organisation with a Memory�..��106 Building a safer NHS for patients��106 Doing Less Harm��..��106 Pilot Project��..��.109

38

Public and Media Opinion��111 Action for Victims of Medical Accidents��.��111 Media Coverage��..��.111 Regulatory, Legal and Insurance Issues��.��112 Malpractice Insurance Issues��.112 Patient Complaints��...117 Role of Professional Governing Bodies��118 Qualified Privilege��119 Gaps��..120 Future Plans��121 Announcements Made in Response to Bristol Inquiry��121 Other Future Initiatives��.122

UNITED STATES��.123 Background��123 Health Care System��123 Reports and Studies��.��124 Harvard Medical Practice Study��.��124 To Err is Human��...124 Doing What Counts for Patient Safety��.��.127 Making Health Care Safer��..127 Crossing the Quality Chasm: A New Health System for the 21st Century��.128 National Initiatives��..��. 130 Targets��.��. 130 Quality Interagency Coordination Task Force��.131 Agency for Healthcare Research and Quality��.132 AHRQ Research Program��..133 Veterans Administration��..134 Joint Commission on Accreditation of Healthcare Organizations��134 National Patient Safety Foundation��..136 Leapfrog Group��136 MedWatch��.137 Institute for Safe Medication Practices��.138 National Quality Forum��139 Patient Safety Institute��140 State Initiatives��..�� 141 California��141 Massachusetts��..141 Minnesota��..142 Pennsylvania��.142 Rhode Island��.143 Texas��..143 Wisconsin��..144 Virginia ��..144

39

Error Reporting Systems and Data Analysis��.��.145 Public and Media Opinion��146 Commonwealth Fund Patient Survey��146 Pushing the profession: how the news media turned patient safety into a priority ��...146 Regulatory, Legal and Insurance Issues��.147 Malpractice Insurance��..147 Qualified Privilege��.149 Assessments of Patient Safety Initiatives��..150 Making Health Care Safer��..��.150 The Challenge of Assessing Patient Safety in America's Hospitals��.151 Gaps��..154 Hospital Focus��...154 Reporting is Largely Voluntary��154 Lack of Overall Coordination��..154 Commission But Not Omission��...154 Self-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 the United States - August 2002

40

AUSTRALIA BACKGROUND System of Government Australia is a federal state with 6 States and 2 Territories. The Constitution gives the Commonwealth (federal) Parliament specified powers; all other powers reside 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 in national 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 a wide range of community and public health services including school health, dental health, maternal and child health and environmental health programs. The State and Territory governments directly fund a broad range of health services. The Commonwealth funds most medical services out of hospital, and most health research. The Commonwealth, States and Territories jointly fund public hospitals and community care 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 of Medicare. The latter accounts for 30% of health expenditure. Intergovernmental Relations Australian Health Ministers� Conference The Australian Health Ministers� Conference (AHMC) is the senior coordinating body for health policy matters. Over the years, it has commissioned and received several reports on patient safety and quality issues.


41

For example, in August 1999 it agreed to the establishment of the Australian Council for Safety and Quality in Health Care. In August 2001 the conference received and endorsed the Council's annual report. Australian Health Ministers� Advisory Council The Australian Health Ministers' Advisory Council (AHMAC) is the primary national advisory body reporting to the AHMC, and facilitates governments' participation in national programs, thereby achieving a degree of uniformity. The members are the Heads of the Health authorities of the Federal, State and Territory 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 all individuals and organisations with an interest in patient safety. It has representatives on its Council from medical and other health care colleges and the 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 care process than from being in traffic, and 400-fold greater risk than working in the chemical industry." ii It notes that the cost of adverse events exceeds $2 billion per 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 - 10 years if the necessary investments are made in a systematic approach to this problem". APSF initially arose to address anaesthesia safety issues. Its main focus has become 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 Care Professionals and Quality in Australian Health Care Study 1991-1995 This review (�PIR�) was the earliest government initiative that prompted concerns about patient safety. In an effort to obtain data about the incidence of adverse events, it commissioned the Quality in Australian Health Care Study, which used the Harvard Medical Practice Study methodology. The Australian study suggested that there were likely around 230,000 preventable adverse events in Australian hospitals each year, that 30,000 people suffered a permanent disability of some kind, and that between 10,000 and 14,000 people died because 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 Study prompted the Australian Health Ministers Conference of 1995 to establish this task force. Its terms of reference were:


43

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

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

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

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

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

• Recommend further analysis or research to identify and improve control of preventable adverse 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 based on an adverse event ratio of 16.6 percent in Australian hospitals; that would account 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, settlement costs, ongoing disability costs, or loss of productivity. The Task Force made 56 recommendations in its 1996 final report. The key recommendations 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 programs iv

The Task Force estimated that the implementation cost for the Safety and Quality Council would be $166.3 million over five years. An additional $152.4 million would 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 on Safety and Quality in Australian Health Care (NEAG) in October 1996 following receipt of the recommendations of the Task Force on Quality in Australian Health


44

Care. NEAG�s role was to advise Health Ministers on mechanisms for enhancement of the quality of Australian health care. NEAG issued an interim report in April 1998 v and a final report in July 1999 vi. In its 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 improvement rests 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 parties about areas for quality improvement, and to ensure that patients, their families and careers and health care agencies receive timely advice about incidents.

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

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

6. Develop a national framework for health service performance measurement and reporting.

7. Facilitate improvements in the quality of current accreditation mechanisms that address 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 a system-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 collaborative approaches to health care delivery. viii

NEAG also reiterated the Task Force�s recommendation that a Safety and Quality Council be established. It recommended that governments provide $17.4 million over four years to support the implementation of the �national actions� and to establish the Safety and Quality Council. Australian Health Care Agreements 1998-2003 The Commonwealth government contributes to medicare funding. The breakdown of health expenditure is: Commonwealth government, 47%; state governments, 23%; and non-government, 30%. ix These funds are transferred to State/Territorial governments on the basis of a new mechanism, Australian


45

Health Care Agreements. 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 �Quality Improvement 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 for national commitment, in partnership with clinicians and consumers, to health care safety and quality improvement and recognize that there are some safety and quality issues which 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 grant year of the Agreement, a Strategic Plan to advance quality improvement and enhancement 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 the national 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, and

fostering 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 the dissemination of best practice. xii

The Agreements specify that Commonwealth funds can be allocated to states and territories to support quality improvement and enhancement programs throughout the life of the Agreements. The Commonwealth government has allocated 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 territories agreed 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 Quality

6. 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 was the 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 Australian body. The Council has 22 members, 10 of whom are identified as professors. Twelve are physicians. Most members wear at least two hats. For example, they have related 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 a lawyer. The Council receives advice and assistance from the State Quality Officials Form, a body the Council created. The Council's role is, �To lead national efforts to promote systemic improvements in the safety and quality of health care in Australia with a particular focus on minimizing 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 and quality improvement

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


47

3. Negotiate with the Commonwealth, states and territories, the private and non-government sectors for funding to support action in agreed priority areas

4. Widely disseminate information on activities of the Council including reporting to Health ministers and publicly at the agreed intervals

The 2001-2002 Commonwealth budget committed $22 million over four years to support the Council�s work.xvi State and Territorial governments have committed an additional $33 million over five years to fund the Council's action plan programs. "Lead jurisdictions" volunteer to head up various projects. Safety and Quality Council Action Plan 2001 This Action Plan has four priority areas: 1. Better use of data to identify, learn from and prevent error and system failure 2. Supporting those who work in the health system to practice safely 3. Actively promoting opportunities for consumer feedback and participation 4. Redesigning systems and facilitating a culture of safety xvii In each priority area numerous actions are outlined. A few are reproduced below: • Producing a First National Report to Health Ministers on Patient Safety with particular focus

on deaths and serious injury attributable to health care and to outline the planned implementation of a national reporting system including � recommendations about the possible role for mandatory reporting in relation to serious errors and the solutions being put in place to address known risk factors

• New South Wales and Queensland to lead national work to develop national standards for robust models of credentialing and clinical privileging in health care facilities encompassing consideration of peer and performance review processes and effective approaches to organizational accountability for safety and quality improvement

• Tasmania to lead work on developing standards and guidelines for health care providers and facilities about actions to take place when an adverse event has occurred (for example, to avoid "communication shut down") xviii

The budget breakdown for the four priority areas outlined above is:

AUS$ Millions Year 1 Year 2 Year 3 Year 4 Year 5 Total Data & Information 1,350 3,900 3,750 2,550 2.050 13,600 Standards and Accreditation 360 1,500 3,800 3,200 2,700 11,560 Consumer Feedback & Participation

490 900 1,350 1,000 750 4,490

Cultural Change 2,600 8,650 6,300 4,900 3,900 26,350 TOTAL 4,800 14,950 15,200 11,650 9,400 56,000


48

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 for Consultation

• A Draft Model for Medical Registration -- for consultation

• Public Interest in Health Care Qualified Privilege: Issues Paper in Safety in Numbers: A Technical Options Paper for a National Approach to the Use of 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, professional registration and renewal, and the granting of hospital privileges. These are described 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 facility has been accredited that it equates with an assurance that health care is provided safely�. xix

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

To ensure an appropriate evidence base and a clear link with safety, the development of core safety standards should be led by professionals qualified and experienced in the evaluation of clinical research, evidence-based medicine and standards development. The National Institute of Clinical Studies [described below] or the National Health and Medical 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 a similar, 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 current system 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 practice in an area of medicine in which they are demonstrably competent� medical graduates may be granted registration on completion of internship and have this renewed for 40 or 50 years without any commitment to maintaining and updating their knowledge and skill�. xxii The Council proposes that professional development and recency of practice be directly linked to renewal of medical registration. xxiii Credentials and Clinical Privileges Guidelines This paper proposes principles and processes for a national guideline on granting and renewing institutional clinical privileges. Some of the principles are:

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

• The [institution�s] governing body will have systems in place for the early identification and management of compromised performance including that relating to incompetent or impaired practitioners xxiv

Commonwealth Health Occasional Paper on Quality 2000 The Commonwealth Department of Health and Aged Care published an Occasional Paper in 2000 titled,� The Quality of Australian Health Care: Current Issues and Future Directions.� xxv Although largely a literature review, it does provide 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 and Sutherland (1998) note, it is, after all, rare to find anyone who is opposed to the notion of high quality. Within Australia, however, there has been little evidence that key stakeholders have a shared understanding of the concept of quality. There is an absence of agreed standards and a lack of explicit, agreed national goals for quality improvement. In a complex health care environment, this has made it difficult to drive forward a meaningful and appropriately integrated national quality agenda. This situation has been marked by continuing debate about the extent of the gap between existing and optimal 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 continuing improvement in quality and safety of health care are best built into system design and financing arrangements;

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

• strengthening the capacity of consumers to play an informed role in achieving health care quality (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 including support for national mechanisms such as the Australian Council for Safety and Quality in Health 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 safety improvement 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 the gaps between evidence and clinical practice, in those areas that will effect significant change for the Australian community" and to "facilitate cultural and attitudinal 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� that have this responsibility. NICS does, however, need to work with these organizations to develop and implement effective mechanisms for the transfer of this evidence into improved clinical care. xxx

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


51

STATE/TERRITORIAL INITIATIVES The table below summarizes state/territorial activities in patient safety. NSW Victoria Queens-

land Western

Aust. South Aust .

Tasmania ACT Northern Territory

Quality Council ! ! ! ! ! Strategic Plan ! ! ! ! ! Area Quality Councils

!

Quality Branch ! ! Reporting System

! Plan

Root Cause Analysis

!

Chart Review ! Risk Management

! !

At this stage we have been unable to obtain information about South Australia, Tasmania and the Northern Territory. To qualify for Commonwealth quality and safety funding they likely have established quality councils and have developed strategic 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 Council reports to the Minister of Health. The Council's Terms of References are as follows:

Role

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


52

• Provide advice and make recommendations as appropriate on any other matter concerning 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 the Committee, in particular to provide recommendations about the routine availability of meaningful 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 improving health care

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

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

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

The Council has 18 members, most of whom are physicians. Also included are a nurse, a consumer, and a representative of the airline industry. The Council has a 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 care services in NSW.

2. Measurement and improvement of patient safety using selected quality of care indicators.

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

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

The Council has a series of working parties, including one on "Safety". The terms 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 advice and recommendations, consulting with stakeholders and reviewing the Council�s Terms of Reference.

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

• Recommend measurement and improvement of patient safety using selected quality of care measures

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

• Recommend an implementation and research agenda designed to demonstrate how such a framework would operate. This should include a specific project that can 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 Care developed A Framework for Managing the Quality of Health Services in NSW (the �Framework�). This report identifies "six dimensions of quality", the first of which is �safety�. Safety is defined as:

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

The Framework includes a list of "characteristics" of a "quality oriented health service" that includes "an emphasis on preventing adverse outcomes through simplifying and improving the processes of care." Another characteristic is: "A robust advisory and reporting structure designed to promote the quality improvement 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 is a 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 is inevitable accompaniment of the human condition, even among conscientious professionals with high standards. Errors must be accepted as evidence of system flaws and 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 a committee of the Area Health Service Board, the operating agency. The purpose of the Council would be to "define and, measure, monitor, improve, and report to, consumers, the clinicians and managers on the services, the Area Health Service Board, 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 in improving the quality of health care for the people in NSW;


55

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

• To commission studies, projects and other work designed to improve the quality of 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 in health care and about issues relating to the quality of health care;

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

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

Quality of Care Indicator Reporting As part of the implementation of the framework, Area Health Services are being required to provide regular reports to the Quality of Health Care Unit in the Department of Health about the quality of health care they are providing. One set of 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 2000 Report xxxviii, NSW reported that no safety indicators were available for immediate use. Victoria With a population of 4.8 million Victoria is Australia�s second-largest state. In 2001-2002 Victoria is introducing 5 new patient safety initiatives outlined in the Clinical Risk Management Strategy, 2001 xxxix (the �Strategy�), based on the report 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 a comprehensive approach to Clinical Risk Management (CRM).


57

As is illustrated below, the report�s recommendations about reporting systems have been implemented.

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


58

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

• Advise the Minister for Health and the Department of Human Services on the actions that 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 Consultative Councils, Department of Human Services Advisory Committees, and Health Service Quality Committees, in fostering quality improvement in Victoria�s health services.

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

• Analyse information about systemic safety and quality issues presented to the Council 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 practice approaches for dissemination.

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

• Provide advice on matters relevant to the quality of health services in Victoria as requested 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 a predominantly medical membership. According to the Clinical Risk Management Strategy, the Victorian Quality Council will receive recommendations from regional Consultative Councils. The Victorian Quality Council�s endorsement of recommendations will be required prior to statewide system changes being made.xli The Council has not yet produced any reports. Clinical Incident Reporting In addition to its Sentinel Event Reporting system, Victoria is also introducing a Clinical Incident Reporting system:

Metropolitan health services and large regional hospitals are expected to implement an incident reporting system to receive reports of adverse events, potential adverse events and 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 should actively encourage hospital staff to participate.

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


59

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

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

Four Victorian hospital networks also use the Australian Incident Monitoring System. Statewide Sentinel Event Reporting In addition to the Clinical Events Reporting system, Victoria is also introducing statewide Sentinel Event Reporting. Sentinel events are defined as "relatively infrequent, clear-cut events that will occur independently of a patient's condition; commonly reflect hospital system and processed deficiency; and result in unnecessary outcomes for patients."xliii Part of the Sentinel Event Reporting Form is reproduced below to illustrate the system�s scope.


60

All hospitals are required to report Sentinel Events to the Department of Human Services 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 a Sentinel Event, the hospital must submit a Root Cause Analysis on the form specified by the Department. The form being used is a modified version of the Joint 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 the organization intends to implement, to reduce the risk of similar Sentinel Events occurring in the future. The RRAP should address responsibility for implementation of each Action Item identified, pilot testing as appropriate, timelines, book or journal references considered in the development of the Action Items, and strategies for measuring the effectiveness of the Action Items. xliv

Limited Adverse Occurrence Screening (LAOS) Victoria is also introducing, initially in Melbourne and its suburbs [called Metropolitan Health] and large regional hospitals, followed by rural hospitals, a chart review system called Limited Adverse Occurrence Screening. It is described 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 a consequence of the patient�s disease or treatment.� The adverse event is then classified according to the certainty with which an adverse event has occurred, severity and preventability. Adverse events are analysed, and recommendations aimed at preventing these events from recurring are made and implemented. LAOS is an effective way of identifying local system problems in clinical care, and has been shown to be an effective mechanism for engaging physicians in the process of clinical risk management (CRM). As its name suggests, it does not aim to identify all adverse events, and as such it limits the number of adverse events detected. Despite the limitations in being able to produce quantitative data about adverse events, there is evidence of a decline in adverse events found when using these criteria.xlv

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

• Death

• Unplanned return to operating suite within 7 days

• Transfer from general ward to intensive care


61

• 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 Care Report by each hospital. The Report is expected to include the following information 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 events detected; and

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

The Strategy states that, �Current successful [LAOS] programs have a full time staff member dedicated to the program�, and ��the involvement of respected physicians and nursing staff with a proportion of their paid work hours dedicated to the program�. Quality and Care Continuity Branch The introduction of these new systems into Victorian hospitals is being supported by 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 is undertaking the following patient safety initiatives:

• Strategic Plan for Quality: Quality Improvement and Enhancement Program: 1999 � 2004

• Queensland Health Council on Safety and Quality in Health Care

• Clinical and Non-clinical Risk Management Program


62

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 to report on the performance of services in Queensland Health.

2. Encouraging members of the community to take active responsibility for

their health and well-being by being informed and involving them in health service decision-making

3. Developing a culture of quality through continuous education of health

service providers to ensure health services are safe, appropriate, effective, efficient, and accessible

4. Improving the coordination of health services and programs and

collaboration between health service providers and with other government and non-government sectors

5. Developing client/patient-centred information systems to facilitate the

delivery and evaluation of health services 6. Providing evidence based health services which are outcome focused and

encourage 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 and training of staff, particularly clinicians, and the use of an evidence-based approach in the delivery of health services." xlix Although many of the 22 program areas will undoubtedly contribute to patient safety, two are directly relevant. The first one is Risk Management. This is to develop �a risk management framework for clinical and non-clinical areas throughout the organization" by June 2003. By that time the expected deliverables are:

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


63

• Model for system-wide monitoring and review The Risk Management program is also to develop an Incident Monitoring system by June 2003. The Plan does not set out strategies or deliverables. The second program directly related to patient safety is Patient Complaints and Surveys. By June 2003 this program is expected to deliver the following:

• Corporate policy and guidelines for collection and use of data management 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 within Queensland Health incorporate risk management and quality improvement approaches

2. To endorse an operational plan to guide the implementation of clinical risk management 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 quality improvement strategies across Queensland Health's Zonal Health Services, Units and Branches

6. To critically appraise and incorporate where appropriate, international and national innovations in health service development, particularly in the areas 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.


64

Western Australia The State of Western Australia has a population of 1.9 million. Western Australia has 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 initiatives are embedded in an overall quality improvement plan. Interim Quality Council The Strategic Quality Plan called for the establishment of a Western Australia Health Services Quality Council. The purpose was to �provide overall guidance at a macro level. The implementation of the Strategic Quality Plan will be influenced by this Council. The Council will oversee a system-wide perspective on 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 available on it at this time. Risk Management Initiative Western Australia intends to develop and implement an integrated risk management 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 health industry

• Ensure that management and employees are accountable for risk management

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


65

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

It is expected that this system will enable efficient aggregation and analysis of data to identify baseline incident rates, trends and patterns of incidents and contributing factors. It will also promote the development and evaluation of initiatives to prevent and reduce the number and severity of clinical incidents. The system will be introduced to all Metropolitan 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 MHS and to the hospitals and health services on a quarterly basis in order that areas of concern may be identified and remedial action taken. A new method of categorizing complaints has been developed in order to maximize the usefulness of the information. Medico-legal claims have similarly been placed under much closer clinical scrutiny to inform administrators and clinicians of the principal issues that give rise to legal action and which adversely affect patient care. lii

MHS also reported that it had received $300,000 funding from the Interim Quality Council for three projects, including the Monitoring of Adverse Events: a public health approach. Australian Capital Territory (Canberra) The Australian Capital Territory (ACT) has a population 320,000. It has taken the following 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 system o legislative requirement for all health facilities to participate in quality

improvement o 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 the assumptions about patient safety:

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


66

• there is a strong correlation between safety and quality - diminished standards of safety reflect 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 the safety and quality of health care services; and

• error is an inevitable part of the human condition - systems need to be designed to recognize this and not to be based upon unrealistic expectations of perfection liii

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 the implementation of the strategic plan and action plan outlined below. The Forum has representation from hospitals, community care agencies, the consumers association, 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 under the Australian Health Care Agreement. It also responds to an earlier Patient Safety Action Plan commissioned by the territorial government. A survey done as part of the earlier Plan found the following in ACT health care facilities:

• Cultural and practical problems dealing with mistakes and system based errors;

• very little measurement of outcomes across the system and few feedback loops 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:


67

Goal: Potential risks to consumers are avoided and inadvertent harm minimized in the care 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 goal quoted 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 annual deidentified public reports on trends, recommendations for action and progress from recommendations from the previous year


68

ERROR REPORTING SYSTEMS AND DATA ANALYSIS This section consolidates information on Australian error reporting and data analysis 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 Safety Foundation. The State/Territorial reporting systems are new, mandatory, with the information going to the State/Territorial health departments. It is not always clear what the relationship is going to be between the AIMS system and the new State/Territorial systems. There is also the issue of whether individual case or aggregate 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 was changed to an incident monitoring model usable on an institutional basis rather than merely a specialty basis. The Commonwealth Government provided funding for this change so that the results could be used by the Professional Indemnity 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 Australian Capital Territory and Western Australia and to parts of New South Wales, Tasmania and Queensland. 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, what the contributing factors were, what treatments or investigations are ordered, what factors minimized the adverse outcome, and what could have been done to prevent the incident. The first part of the form is filled out by health care providers and the second part by an institution's management. The management part of the form collects information about the incidence outcome. The data on the form is coded locally using a �Generic Occurrence Classification� system developed by APSF. The AIMS database had almost 26,000 incident reports in its database at April 2001. 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 Quality of 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 does not appear to be an adverse incident reporting system per se. AIMS is not being used uniformly across New South Wales. Thus, this appears to believe a significant gap in Australian incident reporting because New South Wales is the largest state. Victoria Clinical Incident Reporting As noted above, Victoria�s hospitals were to have a clinical incident reporting system 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 introducing statewide Sentinel Event Reporting. Sentinel events are defined as "relatively infrequent, clear-cut events that will occur independently of a patient's condition; commonly reflect hospital system and processed deficiency; and result in unnecessary outcomes for patients�. The reports are sent to the Victoria Department of Human Services. Queensland Incident Monitoring The Queensland Risk Management program plans to develop an Incident Monitoring system by June 2003. Western Australia Computerized Incident Management System The largest health care provider organization in the state is the Metropolitan Health Services (MHS). It operates 12 hospitals and other facilities in the greater Perth area. In its Annual Report 2000/2001 the MHS reports that it has implemented a Computerized Incident Management System. ACT Adverse Event Incident Monitoring System As part of its Action Plan, the Australian Capital Territory plans to implement a statewide adverse event incident monitoring system/program.


71

Summary Table: Reporting Systems State/Territory AIMS State Incident

System State Sentinel Event System

New South Wales Partial Victoria Partial Yes Yes Queensland Partial Planned Western Australia All Planned South Australia All Tasmania Partial Australian Capital Planned Planned Northern Territory All

Data Reporting and Analysis Safety in Numbers: A Technical Options Paper for a National Approach to the 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 and adverse events in ways that are useful for improving safety and very few give any information about factors that contribute to the occurrence of these events. There is no single source of statistics that provides a reliable measure of the frequency or nature of adverse 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 place which meet agreed national specifications and are capable of contributing nationally consistent 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 an adverse 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 which lead to serious patient harm lvii


72

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 were similar to ones used by the National Patient Safety Foundation in a 1997 survey. "This survey represents the self-reported experiences of the general population using lay judgments of risk and what constitutes an adverse event". The survey found a 6.5% incidence of self-reported adverse events. The survey also asked whether patient safety has improved, stayed the same or become worse. The chart below reports the responses by age group.

Source: Richard B. Clark, Australian Patient Safety Survey. Commonwealth Department of Health and Aged Care, August 2001, p. 85 The survey author notes that the 45-54 age group is most likely to believe that patient safety is becoming worse.

Patient Safety Trend by Age Group


73

Medical Error Action Group This is a public interest organization that claims to have 11,000 members. lviii It has submitted a brief to the Commonwealth government proposing that a system similar to that used by the Veterans Affairs Medical Centre in Lexington, Kentucky be adopted in Australia. This system encourages the admission of medical mistakes and volunteers compensation to victims. Former President, Australian Medical Association In a commentary broadcast on the Australian Broadcasting Company national radio 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 30 years and a good deal of related activity. However, I believe that very little that is truly effective is being achieved. A quick glance at the daily media only serves to confirm this, the latest being three cases of deaths associated with errors in blood transfusions in three of our hospitals. The rate of so-called "adverse events" producing 18,000 avoidable deaths annually has been well documented. Long experience in this area convinces me that governments, hospitals and doctors simply have not addressed the fundamentals needed to provide a solution to the problem� the establishment of committees at National or State level, no matter how prestigious the memberships, will never enable Governments to guarantee quality of care in hospitals. Improving quality can only occur at the workface. Government's role is to introduce "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 a lengthy commentary by Mike Steketee, the papers national affairs editor, entitled, "Nation dawdles over hospital deaths". This ran just after the Institute of Medicine study was published in the United States. The piece is quite critical of the Australian initiatives:

This [U.S. and British] sense of urgency about a rapidly emerging issue is notably absent in Australia�. Federal Health Minister Michael Wooldridge has just appointed Bruce Barraclough of the College of Surgeons to head a 20 member Australian Council for Safety and Quality in Health Care. It is the first substantial measure the Federal Government 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 which suggested there was a serious problem. There have been some steps taken since then by the NSW and Victorian governments but very few by other states and the Commonwealth, 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 a view of the health system which is broader then your average college president". But he is far from a radical.


74

Like Wooldridge, Barraclough discounts the actual figures on adverse events, while acknowledging 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 any reforms. But doctors are part of the problem and they have resisted changes which they believe contain even the slightest hint of inhibiting their clinical freedom. The concern is whether the changes will go far enough� Having been among the first to look at this issue in 1995, Australia now shows every sign of being left behind in its response.


75

REGULATORY, LEGAL AND INSURANCE ISSUES Qualified Privilege Both the Commonwealth Government and State governments have "qualified privilege schemes" to protect information used in quality assurance or practice improvement programs. The Commonwealth scheme applies to quality assurance processes that take place in more than one state, or where a quality assurance activity involves a methodology that is new in Australia or has the potential to affect the quality of health care on a national scale. In the Commonwealth scheme, the quality assurance program must seek a declaration from the Commonwealth Minister of Health that the program is covered by the legislation. There is an application and review process to determine 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 previous activity; and

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

Once designated, a quality assurance activity must keep confidential all the information that identifies individuals that became known solely as a result of the declared activity. The confidentiality requirement does not apply to aggregate, no-identifying information. The State schemes apply to quality assurance bodies that operate in only one state, and usually the Commonwealth scheme is not used in such State-specific programs. The chart below summarizes the various provisions of Commonwealth and State schemes.


76

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 proposed National Principles to Underpin Qualified Privilege. These are:

• Qualified privilege schemes should seek to strike an appropriate balance between the public interest in access to information, and the public interest in removing barriers to participation by health care professionals in meaningful safety and quality activities

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

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

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

• An avenue should be available for referral to appropriate professional, administrative and 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 would be regarded as unacceptable standard of care


77

• Participants of protected activities and the broader community should be aware of qualified 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 be administratively simple and transparent to both the public and the health care industry. lx

It would appear that all the Australian qualified privilege schemes are somewhat compromised by the fact that Freedom of Information Legislation overrides all of them.lxi Malpractice Insurance Issues Review of Professional Indemnity Arrangements for Health Care Professionals This Review (�PIR�) occurred between 1991 and 1995 and was commissioned by the Commonwealth Government. The concerns that prompted its establishment were:

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

• operation of the current fault-based compensation systems sometimes conflicts with broader public health policies such as the desirability of immunization. For example, by acting as deterrent to manufacturers of therapeutic goods and doctors where their activity is 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 been rapidly increasing; and

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

In 1991 the PIR commissioned a feasibility study on reproducing the Harvard Medical 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 the Commonwealth Minister for Human Services and Health in June 1995:

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


78

In response to the study results, the Australian Health Ministers Conference in June 1995 agreed to establish the Task Force on Quality in Australian Health Care. 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 outcomes which arise out of health care in the Australian health care system - probably considerably in excess of 400,000, with around 230,000 being preventable with current knowledge 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 was likely to prevent the person returning to work or normal activities for between 1-12 months, 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 preventable and 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 with tort reform and removing disincentives from rural practice. lxvi It did note the relationship 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 the collapse of the country's largest malpractice insurer, United Medical Protection. UMP is akin to the Canadian Medical Protective Association. UMP was formed in 1997 when the British Medical Protection Society and Medical Defence Union left the Australian market. UMP represented more than 40,000 of Australia's 55,000 doctors. This had been preceded by the bankruptcy of HIH, Australia's largest insurance group. It had covered some physicians. The situation has also recently been exacerbated by the withdrawal of the U.S. St. Paul group from all malpractice insurance markets, including Australia. In 2000, UMP paid out an unprecedented $95.8 million to 1,035 claimants. One payout was $9.3 million, with eight additional cases receiving payouts of more than $1 million. In that year, it had more than 20,000 incidents on its books and


79

more than 4,000 unsettled claims. lxvii In December 2000, UMP called on all its members to pay an additional year's premium to boost its reserves. It also imposed 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 to enter the medical indemnity market on July 1, 2002 provided the following conditions are met:

• Cover be provided on a "claims made" basis for incidents occurring after the entry of commercial 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 a more sustainable basis.lxviii

On April 23, 2002 a Ministerial Meeting on Medical Indemnity was held in Canberra. It included all Health Ministers and the Commonwealth Minister for Revenue and Assistant Treasurer. The Commonwealth agreed to introduce legislation to make tax changes to encourage structured settlements and to develop broadly based tort law reform measures. The Ministers also noted the relationship to patient safety:

Health Ministers therefore reaffirmed their commitment to joint Commonwealth, State and Territory 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 from medical events. They agreed that:

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

• Health Ministers will develop nationally consistent legislative proposals to ensure that 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 all medical negligence claims. It will include data from the Health Insurance Commission compensation recovery database, and efforts will be made to include data from Medical Defence Organizations. It is hoped that the database will be ready by July 2002. lxx


80

In June 2002 the Commonwealth and state governments jointly appointed a panel chaired by a Supreme Court judge to investigate various aspects of negligence 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 professional governing bodies do not appear to have played any significant role in the development of patient safety initiatives. For example, they appear not to be represented 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 quality were found. The medical licensing bodies� peer review processes are reactive � requiring a complaint � rather than proactive. However, this may change as a result of an item in the Safety and Quality Council�s Action Plan:

New South Wales and Queensland to lead national work to develop national standards for robust models of credentialing and clinical privileging in health care facilities encompassing consideration of peer and performance review processes and effective approaches 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 Complaints Commissions. The latter are independent statutory bodies. Complaints may also be registered against hospitals and any other public or private facility where care is provided, as well as unregulated providers. The commission has independent investigatory power. In New South Wales, for example, 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 should be 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 a recommendation 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 error reporting system (AIMS) it is not universally used across the country. The Victorian 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. There appear 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 cases seem to be excluded.


82

FUTURE PLANS Australian Health System Safety Surveillance Unit It has been agreed that an Australian Health System Safety Surveillance Unit will be established by the Australian Patient Safety Foundation as a Collaborating Unit of the Australian Institute of Health and Welfare to coordinate the ongoing collation and analysis of information at a national level.lxxv (This Institute is akin to 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 national database for all medical negligence claims. It will include data from the Health Insurance Commission compensation recovery database, and efforts will be made to include data from Medical Defence Organizations. It is hoped that the database 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 identified medication safety as a priority area and proposed a project to �reduce medication error 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 regulation to identify barriers to and opportunities to improve safety.lxxvii


83

Chronology of Australian Patient Safety Initiatives

1989 Australian Patient Safety Foundation (APSF) established 1991-1995 National Review of Professional Indemnity Arrangements for

Health Care Professionals

1995 Task Force on Quality in Australian Health Care established 1995 Quality in Australian Health Care Study released 1995 State of Victoria Professional Indemnity Review 1996 National Expert Advisory Group on Safety and Quality in

Australian Health Care (NEAG) established by Australian Health Ministers

1996 APSF establishes Australian Incident Monitoring System (AIMS)

1998-2003 Australian Health Care Agreements allocate $660 million of Commonwealth funding to hospitals quality and safety initiatives

1999 NEAG�s Final Report, Implementing Safety and Quality Enhancement in Health Care released

2000 Improving Patient Safety in Victorian Hospitals published

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

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

2001 Australian Patient Safety Survey published


84

UNITED KINGDOM BACKGROUND System of Government In 1998 the U.K. introduced devolution of certain authority to Scotland and Wales, thus transferring political decision-making in some defined areas from the U.K. Parliament at Westminster to the Scottish Parliament and the National Assembly for Wales. Some areas are reserved for Westminster, including the regulation of the professions. Other areas, such as �health and personal social services�, have been devolved to Scotland and Wales. Scottish Ministers exercise executive authority over the National Health Service (NHS) in Scotland, for example. In Wales, the National Assembly for Wales exercises both legislative and executive authority, including over the Welsh NHS. Westminster continues to govern England. Scotland and Wales can co-operate administratively with England through �concordat� agreements. lxxviii Thus, there are three jurisdictions in the U.K. responsible for the delivery of health care. In this paper, all initiatives apply to England, most have been adopted 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 care delivery vehicle. The regional structure of the NHS is in the midst of changing from 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 for the 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 are hospital-based organizations, but can also provide community services.lxxix The English NHS structure is illustrated below:


85

Source: NHS Website

The U.K. spends 6.7% of GDP on health. lxxx The government plans to increase NHS 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 59.1 million.


86

REPORTS AND INQUIRIES In the last four years there have been eleven significant reports published in the U.K. that deal directly with patient safety matters. These reports have provided significant impetus for the development of patient safety initiatives. These initiatives are described below, but first we review the reports. They are presented in chronological order to show the development of patient safety issues. Seven of these reports have been published in the last 18 months. The milestone reports were An Organisation with a Memory in May 2000 and The Bristol 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 of accessibility, rate variability and quality. Although the paper did not deal explicitly with patient safety issues, many of the initiatives announced in the paper have come to have a direct bearing on patient safety. Among the initiatives announced 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 cases hitting the headlines which have shown that a small number of doctors are providing poor or inadequate care�[which is damaging] public confidence in the ability of the National Health Service to deal with problems quickly, effectively and fairly�. lxxxii The paper stated that, �The current procedures for detecting and dealing with poor clinical performance are fragmented and inflexible�.lxxxiii In the paper, �The Government proposes the abolition of the existing disciplinary procedures and the establishment of a new integrated process involving NHS and professional bodies.� lxxxiv The proposed new procedures were:

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


87

• 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�s disciplinary 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 Support Centre.

The Assessment and Support Centres proposal was not implemented. Instead, a National 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 from adverse events in the National Health Service, chaired by the Chief Medical Officer. The expert group included physicians, professors of medicine, professors of nursing, hospital administrators, risk management experts, psychologists, and officials involved in adverse event investigations. The terms of reference were:

To examine the extent to which the National Health Service and its constituent organizations have the capability to learn from untoward incidents and service failures so that similar occurrences are avoided in the future. To draw conclusions and make recommendations.lxxxv

Of all the U.K. reports, this is the most comprehensive and influential. It has attracted significant international attention. Many of the initiatives outlined below stem 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) adverse events might occur each year in the NHS hospital sector, resulting in a £2 billion direct cost in addition to hospital days alone; some adverse events might be inevitable complications 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 to drugs

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

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


88

• 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 to cost the NHS nearly £1 billion. lxxxvii

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

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

The report develops the idea of a �safety culture� in organizations that transcends any specific measures. The report notes, " Airlines operate globally with similar equipment, training and licensing, but the risk to passengers among different 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 critical subcomponents of an informed culture:

• a reporting culture: creating an organizational climate in which people are prepared to report their errors or near-misses. As part of this process data need to be properly analyzed 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 people are encouraged to provide safety-related information - at the same time being clear about where the line is drawn between acceptable and unacceptable behaviours.

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

• a learning culture: the willingness and confidence to draw the appropriate conclusions from its safety information system, and the will to implement major reforms where their need 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 the effects of individual failures

• Sound safety information systems are a precondition for systematic learning from failures. 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 be learned before a major incident occurs

• Given appropriate approaches to analysis, it is possible to identify common themes or characteristics in failures which should be of use in helping to predict and prevent future adverse events.xcii

The report analyzed gaps in the National Health Service incident reporting systems:

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

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

• Regional Offices of the NHS Executive are charged with establishing and maintaining systems for reporting and monitoring incidents beyond the organizations immediately concerned, but there are major differences in the approach taken in the eight parts of the country

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

• There is no standardized approach to investigating serious incidents at any level. Most involve internal enquiries, some involved in external enquiries but the way in which a decision 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 of Dr. Harold Shipman, the Lancashire General Practitioner convicted earlier this year of murdering 15 of his patients, is fortunately exceptional, yet it serves as a powerful illustration of the implications of the major deficit in the reporting of serious adverse events at source ". xciv


90

The report made 10 recommendations:

1. Introduce a mandatory reporting scheme for adverse health care events and specified near 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 adverse health 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 adverse health 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 of the safety and quality measures the NHS is putting in place, the details of which can 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 who represents a danger to patients from practicing until his fitness to practice has been demonstrated

• Placing a statutory duty on the GMC to notify employers and any other person or body who 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 deal with complaints against practitioners. It also notes, "Where concerns remain about the individual self-regulatory bodies, [the Council�s] role could evolve". xcvi


91

Building a safer NHS for patients: Implementing An Organization with a Memory � April 2001 The Government accepted all the recommendations made in An organization with 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 adverse events 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 annual peer appraisal. This document includes the forms that appraised and appraisers must fill out. �The appraisal process will not of itself result in the generation of significant amounts of new evidence or information, rather it will capture the information 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 Service Litigation Service (NHSLS). The NHSLS covers many NHS trusts, including doctors working in trust hospitals. It currently handles 42% of claims. (Claims against general practitioners are covered by medical protective associations or private insurers.) The audit found the following:

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

• The rate of new claims per thousand finished consultant episodes rose by 72% 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 in March 2000

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


92

A Commitment to Quality, a Quest for Excellence � June 2001 This was a joint statement of the medical profession, the Government, and the National Health Service. The medical organizations signing were: the General Medical Council, the Royal College of Surgeons of England, the Academy of Medical Royal Colleges, the Joint Consultants Committee, and the Specialist Training Authority. The medical organizations endorsed the government's plans to 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 people can 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 make improvements in clinical quality a cornerstone of reform in the NHS. It is change in NHS cultures 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 State for Health, John Denham, stated that, "� the last few years have seen a series of high profile medical scandals". ci Undoubtedly, one of the scandals happened at the Bristol Royal Infirmary's paediatric cardiac surgical service. The Public Inquiry that investigated the service concluded that, "In the period from 1991 to 1995 between 30 and 35 more children under 1 died after open heart surgery in the Bristol Unit than might have been expected had the Unit been typical of other PCS units in England at the time," ciiand that the mortality rate was "roughly double that elsewhere in five out 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 of care. There were no standards for evaluating performance. There was confusion throughout 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 the foundation of quality". cv As part of its terms of reference, the Inquiry was also to make recommendations that could "help secure high-quality care across the NHS". At a system level, the Inquiry stated the following:


93

Around 5% of the 8.5 million patients admitted to hospitals in England and Wales each year experience an adverse event which may be preventable with the exercise of ordinary standards of care. How many of these events led to death is not known but it may 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 the report �An Organisation with a Memory� by the Chief Medical Officer�s expert group on learning from adverse events in the NHS. The National Patient Safety Agency proposed as a consequence of that report should, like all other such bodies which contribute to the regulation 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 environment in 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 and type of sentinel events in the NHS to establish a baseline against which improvements can be made and measured.

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

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

The National Patient Safety Agency, in the exercise of its function of surveillance of sentinel 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 publish regular 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 where they occur, which takes into account not only the conduct of individuals, but also the wider contributing 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 available means of communication, (including a confidential telephone reporting line).

Members of staff in the NHS should receive immunity from disciplinary action by the employer 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 a criminal offence.

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

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


94

There should be a stipulation in every healthcare professional�s contract that sentinel events must be reported, that reporting can be confidential, and that reporting within a specified time will not attract disciplinary action.

The process of reporting of sentinel events should be integrated into every trust�s internal communications, induction training and other staff training. Staff must know what is expected 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, bring together managers in the NHS, representatives of the pharmaceutical companies and manufacturers 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 of Health:

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

The Report recommended the formation of two new bodies to oversee the regulation of health care: a Council for the Quality of Healthcare to bring together those bodies which regulate healthcare standards and institutions; and a Council for the Regulation of Health care professionals to bring together bodies regulating health care professions. Doing Less Harm: Improving the safety and quality of care through reporting, analyzing and learning from adverse incidents involving NHS patients � August 2001 This is a Department of Health/National Patient Safety Agency consultation document that describes work in progress to design a national adverse patient incident reporting system. The proposed system is described below in the section on 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 Kennedy Report) the Secretary of State for Health, Alan Milburn, noted that, "Bristol was the turning point in the history of the NHS. We are determined that some good can come from the tragedy that took place there". cix


95

The Response endorsed "the Kennedy Report�s arguments for separation of the Department of Health's role in management and regulation�". cx and accepted the recommendations that a Council for Quality of Health Care and Council for the Regulation of Health Care professionals be established. By the time the Bristol Inquiry Report had been published, the Government had already committed itself to numerous patient safety initiatives, as the summaries of the preceding reports illustrate. Nevertheless, the government's response outlined more new initiatives. These include:

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

• Patient Advice and Liaison Services to assist patients in managing and accessing 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 their

teams for use by both clinicians and patients • NHS bodies directed to fund treatments recommended by National

Institute for Clinical Excellence effective January 2002, and NICE guidance no longer needing the approval of the Secretary of State for Health before dissemination

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


96

NATIONAL INITIATIVES 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 the initiatives.

Organization Mandate/Process Started Budget NHS Litigation Authority

Clinical Risk Management Standards Compliance Assessments

1997

Department of Health

National Service Frameworks 1998

NHS Organizations Clinical governance 1998 Commission for Health Improvement

Investigate serious systemic service failures Conduct clinical governance reviews

1999 £11.3M

National Institute for Clinical Excellence

Health technology assessments Develop clinical guidelines Promote clinical audits

2000 £13.1M

National Patient Safety Agency

Mandatory reporting of errors and near-misses

2001

Department of Health

Error Reduction/Elimination Targets 2001

National Health Service

Mandatory annual physician appraisals

2001-2

National Clinical Assessment Authority

Assess individual physicians referred by employers

2002 £7.7M

National Care Standards Commission

Regulate private and voluntary health care

2002

In the section below the initiatives are described individually, but it is important to note that they also are inter-related. For example, a physician�s unsatisfactory NHS appraisal could lead to the National Clinical Assessment Authority becoming involved. Given the newness of most agencies and processes all the inter-relationships have not yet been developed. Error Elimination/Reduction Targets In its response to An Organization with a Memory, the Government committed itself to four targets:


97

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

2. To reduce by 25% the number of instances of harm in the field of obstetrics and gynaecology 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 end of 2005

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

These targets were chosen because they are �visible and unambiguous� " and reflected "different facets of the problem of medical error". cxii Each target area has an expert in the field assigned to look at ways of achieving the required reductions. As the reporting and analytical systems mature, new targets will be identified. NHS Clinical Governance 1999 The government�s 1998 White Paper, A First Class Service: Quality in the new NHS introduced the concept of clinical governance. In the U.K., �Every local NHS organization has a statutory duty to assure, monitor and improve the quality of its services. This has been implemented through the clinical governance programme.� cxiii

Clinical governance can be defined as a framework through which NHS organizations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.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 scrutiny cxv

Every NHS organization must nominate a clinician to be responsible for clinical governance and report to the chief executive and board. The Commission for Health Improvement, described below, oversees clinical governance.


98

Commission for Health Improvement

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

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

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

" review and monitor local and national implementation of national guidelines in the form of the 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 NHS incident enquiries in England and Wales;

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

The two prominent products of the Commission are investigations and clinical governance 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 of processes and standards, a pattern of incidents of widespread public concern or other 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 as organisational practices. In an investigation, CHI will draw attention to areas that are failing and make recommendations to ensure that improvement is achieved. The investigators organisation's regional office in England or the National Assembly for Wales will ensure the recommendations are implemented.

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

To date CHI has released 6 investigation reports.


99

Clinical Governance Reviews CHI visits every NHS trust and health authority, including primary care groups every four years to conduct a clinical governance review. There are about 500 NHS organizations. CHI�s model for clinical governance and evaluation questions are reproduced below.

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

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

" Resources and processes: how robust are its processes for achieving quality improvement, such as consultation and patient involvement and clinical audit? How effective 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 level of patient care? cxviii

In its recent response to the Bristol Inquiry, the Government mentioned strengthening CHI by giving it the role of inspection of NHS organizations and service providers against the standard set for NHS, not just investigating problems. CHI spent £11.3M in 2000-01. cxix


100

National Institute for Clinical Excellence The National Institute for Clinical Excellence (NICE) was established in 2000 " to provide patients, health professionals and the public with authoritative, robust and 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 in preparation. 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 their clinical 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 in order to understand and act upon the causes. We will recommend simple methods that health 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 cover additional 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 will be measured. cxxiii

The developmental process is collaborative:

Each NSF is developed with the assistance of an external reference group (ERG) which brings together health professionals, service users and carers, health service managers, partner agencies, and other advocates. ERGs adopt an inclusive process to engage the


101

full range of views. The Department of Health supports the ERGs and manages the overall 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, renal services, and children's national services.


102

Clinical Risk Management Standards The NHS Litigation Authority (NHSLA) runs a Clinical Negligence Scheme for Trusts that �provide a means for trusts to fund cost of clinical negligence litigation and to encourage and support effective management of claims and risk". The scheme includes Clinical Risk Management Standards. cxxv Every three years trusts are assessed for compliance with the standards. Trusts may receive as much as a 25% discount on their premium if they attain the highest level of compliance. 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 in the following categories:

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

o Good medical care o Maintaining good medical practice o Working relationship with colleagues o Relations with patients o Teaching and training o Probity o 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 the appraisee. 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 appraiser believes that the activities of the appraisee are such as to put patients at risk, the appraisal process should be stopped and action taken�. cxxvii


103

The NHS appraisal system is designed to dovetail with the developing General Medical Council five-year revalidation of fitness to practice. GP Appraisal Effective April 1, 2002, appraisal of general practitioners working in the National Health Service is mandatory. The process is very similar to the consultants� process outlined above. The GP being appraised fills out a form, including a development plan, and is interviewed by a peer GP trained to do appraisals. According to the Department of Health, the process �is about identifying development needs, not performance management. It is a positive process, to give GPs feedback on their past performance, to chart continuing progress and identified 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 - assesses systemic 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, taking referrals 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 objective assessment. Following such an assessment, it will advise referring organisation on appropriate courses of action. This way, problems may be more effectively and speedily addressed. cxxix

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

NCAA has memoranda of understanding with the Commission for Health Improvement and the General Medical Council that outline how potentially overlapping 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 assessments by 2004-05. cxxx NCAA has a budget of £7.7M in 20002-03. cxxxi


104

National Patient Safety Agency 2001 One of the government�s responses to An organization with a memory was the creation of a National Patient Safety Agency (NPSA):

The NPSA is an independent body created in July 2001 to co-ordinate the efforts of the entire country to report, and more importantly to learn from, adverse events occurring in the 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 without fear of personal reprimand. It will then collect reports from throughout the country and initiate 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 NHS for 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 but catastrophic 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 of causation, 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 despite widespread dissemination of strategies which have been shown to work?cxxxiii

The NPSA�s major responsibility is to develop and operate a national error reporting and analysis system. Its current state of development is described in the section below, Error Reporting Systems and Data Analysis.


105

National Care Standards Commission

The National Care Standards Commission (NCSC) is a new, independent public body set up under the Care Standards Act 2000 to regulate private and voluntary health care services and social care throughout England. On 1st April 2002 NCSC took responsibility for the registration and inspection of services that include the following independent (non-NHS) health care establishments, some of which 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 on ensuring that patients receive treatment and services that are both safe and quality assured. cxxxiv

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

15. �(1) Subject to regulation 6(3), the registered person shall provide treatment and any other services to patients in accordance with the statement of purpose, and shall ensure that the treatment and any other services provided to each patient� (a) meet his individual needs; (b) reflect published research evidence, and guidance issued by the appropriate professional and 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 Patient Safety Research Program is pursing. The questions are found on page 88 above.


106

The program seeks to avoid duplication of research in other countries, especially that funded by the Agency for Health Care Research and Quality (AHRQ) in the United States. The program funds applied research with potential immediate impact for Health Services. It is currently inviting proposals to be submitted. ERROR REPORTING SYSTEMS AND DATA ANALYSIS The Department of Health is committed to introducing a mandatory reporting and root 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 the first half of 2002. The sub-sections below outline the history of policy development, 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 incident reporting 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 reporting system:

• 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 levels cxxxv

It also gave a mandate to the new National Patient Safety Agency to begin developing 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 reporting system. It states:

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


107

patients�. Identifying and addressing dysfunctional systems is, therefore, the key to reducing future risk of harm� and is the ethos behind the new national system�.cxxxvi

It identifies 10 �key requirements� for local management, reporting, analysing and learning from adverse events:

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

2. The incident is managed and reported to a designated person, or persons, in accordance with 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 relevant external 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 stakeholder reporting 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 three working days of the date of occurrence. For category red adverse events only (i.e. where serious actual harm has resulted), this information is also reported within three working days 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 local organization and reported to the National Patient Safety Agency within 45 working days of occurrence of the incident. For category red adverse events only, (i.e. where serious actual harm has resulted), this information is also reported within 45 working days to the relevant Regional Office of the Department of Health.

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

9. Aggregate reviews of local incident data/information are carried out on an ongoing basis by the organisation and the significant results communicated to local stakeholders. Aggregate review reports are sent to the National Patient Safety Agency on a quarterly basis.

10. Lessons are learned from individual adverse patient incidents, from local aggregate reviews and from wider experiences, including feedback from the National Patient Safety Agency, other agencies/bodies and benchmarking. Improvement strategies aimed at reducing risk to future patients are implemented and monitored by the organisation. Where appropriate, local staff learn lessons and change practice in order to improve the safety 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)


108

• When the incident occurred? (date/time) • Where the incident occurred? (specialty/location) • Who was involved? (patient and staff descriptions, not names, gender, age and

ethnic 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 agency

or body? cxxxviii The reporter subjectively grades the incident in terms of the degree of risk of harm and the likelihood of recurrence on the charts below by marking a box on each of the charts.

Source: Doing Less Harm, p. 24 As noted in point 7 of the Key Requirements above, a root cause analysis of category red incidents must be submitted to NSPA. The document provides an overview 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))


109

• 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, including

media 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 the reporting 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 ran a pilot project reporting system at 28 NHS Trusts in England and Wales. The system solution obtained was from the Australian Patient Safety Foundation. The key findings of the evaluation were:

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

• Such buy-in required a comprehensive communication and education program

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


110

• Systems need to be simplified to make transmission of data as straightforward 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 ten hospital patients � one million per year - are accidentally injured.


111

PUBLIC AND MEDIA OPINION Action for Victims of Medical Accidents The organization Action for Victims of Medical Accidents (AVMA), a charity specializing in providing free independent advice and support to patients who have 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 system for preventing avoidable medical accidents. AVMA also works closely with selected members of the legal profession to ensure that patients have effective, responsive and sympathetic redress for what they have suffered�. Above all AVMA works to raise medical 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 uniquely endorsed to by the Legal Services Commission to select and accredit which solicitors are able 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 safety issues.

Media Coverage

Media coverage of both medical errors and governments� responses has been extensive. For example, the BBC carried 33 stories about the Bristol Inquiry, the Guardian 30, the Times 11, and the Telegraph 11. cxliv


112

REGULATORY, LEGAL AND INSURANCE ISSUES Malpractice Insurance Issues Background The U.K. has a mixed public/private system of providing health care institutions and physicians with malpractice liability protection. The National Health Service Litigation Service (NHSLS) covers many NHS trusts, including doctors working in trust hospitals. It currently handles 42% of claims. General practitioners working outside NHS hospitals are covered by medical protective associations or private insurers. As reported above, a recent audit of NHSLS found the following:

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

• The rate of new claims per thousand finished consultant episodes rose by 72% 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 in March 2000

The charts below illustrate the growth in costs and claims.

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


113

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 a reduction in claims, but rather that numerous claims have not yet been reported. The National Audit Office report found that in 65% of settlements in 1999-2000 below £50,000, the legal and other costs exceeded damages awarded. cxlv In response, the NHSLS is proposing �to launch a Small Claims Manifesto, whereby for low value claims, without litigation and for fixed costs, we will offer a fixed timetable 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 sentinel events represented by the clinical negligence system, this system should be abolished. It should be replaced by an alternative system for compensating those patients who suffer harm arising out of the treatment from the NHS. An expert group should be established to advise on the appropriate method of compensation to be adopted.cxlvii

White Paper The government response, Learning from Bristol, stated:


114

We agree that the current system of clinical negligence compensation needs to be reformed. A White Paper will be published early in 2002 setting out proposals for reforms to the system. This will be informed by a committee, chaired by the Chief Medical Officer, 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 of policy questions that are reproduced below.

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

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

• What is it about the current system which limits its perceived fairness and transparency? 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 organisations managing clinical risk as effectively as they might and, if so, what changes would help to address these? What might be the benefits and dis-benefits of such changes?

• What changes to the current system for dealing with clinical negligence claims would help to ensure that the appropriate lessons were learned from mistakes and further strengthen the incentives to improve the quality of clinical care? What might be the benefits and dis-benefits of such changes?

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

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

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


115

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


116

• What would be the potential benefits and dis-benefits in introducing a system of fixed tariffs for specific injuries? How feasible would it be to introduce such a system? What would be the barriers to change? Would such a system be most valuable if applied to small and medium-sized claims 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 for other personal injuries litigation?

• How do you perceive the current interface between the NHS complaints procedure and the system for dealing with clinical negligence claims? What would be the benefits and dis-benefits of integrating the two systems to streamline 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 to reflect 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 indemnities rather than up-front damages payments?

• What are the potential advantages, disadvantages and barriers to the establishment of a formal Rehabilitation Initiatives, to limit the effect of injuries and their consequent trauma and financial loss? Are there any limitations, in terms of existing expertise and capacity within NHS and Social Services, which affect the practicality of introducing such an initiative? 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? How might such a body work? Are there any existing organisations whose role could be developed to undertake such a function? How might it interact with a system for no-fault compensation, fixed tariffs or the NHS complaints procedure?


117

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

• What, if any, inconsistency is there between the funding arrangements for claimants and defendants costs? What changes might be appropriate to improve the control of costs generally and strengthen incentives to bring claims (especially large ones) to an early conclusion and address the disproportion of costs to damages in relation to small and medium-sized claims?

• What operational links should there be between the system for dealing with clinical negligence claims, the clinical governance framework, risk management 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 reported that, " �ministers hope [these measures] will cap the spiralling legal costs of claims 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 a system 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 causes hundreds of thousands not to find certain things." cli Patient Complaints The NHS has a formalized complaints procedure. Complainants may seek local resolution of their complaint or they may proceed to a non-local independent review. The Bristol Inquiry made recommendations about reforming this system to make it more responsive:

There should be a clear system, in the form of a �one-stop shop� in every trust, for addressing the concerns of a patient about the care provided by, or the conduct of, a healthcare professional. clii

The results of a recent review confirmed that the current complaints procedure is not working at all well from the perspective of complainants:


118

• Among individuals whose complaint was dealt with locally, only one-third believe that their complaint had been handled well. No more than 20-30% were satisfied with the time 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 with the 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. A significant 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 of information and support. The most important structural failure is the perceived lack of independence in the convening decision and in the review process generally. cliii

The Government is introducing reforms to the complaints process. This includes introducing a Patient Advocacy and Liaison Service (PALS) into every NHS Trust. 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, Modernising Regulation in the Health Professions. The introduction states:

It is clear from the Kennedy Report [Bristol Inquiry] and the experience of professional regulation 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 more effective co-ordination of their work and clearer and more robust accountability mechanisms. clv

Legislation � the National Health Services Reform and Health Care Professions Bill � has been introduced and is scheduled for further debate this fall. The Bill contains provisions for the establishment of a Council for the Regulation of Health Care Professionals, as recommended by the Bristol Inquiry. The Council would have a majority of public members appointed by governments, and a minority 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


119

The intention is to make the professional regulatory bodies accountable to the Council; 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 new standard-setting and investigatory agencies, seems to have put in place parallel systems for all governing bodies� functions except entry to practice and discipline. 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 their

employers 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 local

National Service Trust, all of whom will have Patient Advisory and Liaison Services

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

Governing bodies are often partners or recipients of information from these other systems, but the public and the rest of the health care system do not need to rely exclusively on the jurisdiction of a governing body to have a complaint investigated. The General Medical Council in particular does not seem to be keeping pace with the government�s reforms. Its proposals for mandatory physician revalidation are on a five-year implementation schedule, while the government�s own parallel reforms will be accomplished well before then. Qualified Privilege We have been unable to discover at this point whether there is any statutory protection of information collected for quality review purposes. However, NPSA says:

All information supplied to the NPSA, through the national reporting system, will be anonymous. Reports made to the NPSA outside of the national reporting system, by patients or by staff for example, will be confidential.clvi


120

GAPS With at least seven national agencies involved in patient safety initiatives, the issue may be one of overlaps rather than gaps. The UK government recently announced that it is creating a new Commission for Healthcare Audit and Inspection (CHAI) that will bring together the Audit Commission, Commission for Healthcare Improvement and National Care Standards Commission.


121

FUTURE PLANS Announcements Made In Response to Bristol Inquiry, January 2002 Council for the Quality of Health Care and Council for the Regulation of Healthcare Professionals The Bristol Inquiry recommended that two new councils be established to bring together the various bodies that regulate health care. �These overarching organizations must ensure that there is an integrated and co-ordinated approach to setting standards, monitoring performance, and inspection and validation. Issues of overlap and of gaps between the various bodies must be addressed and resolved.� clvii The Government accepted these recommendations but has not yet set up the councils. Legislation to establish the �Regulation� council has been introduced. The councils will report to Parliament. clviii The government �will take further steps at the earliest opportunity to rationalise the 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 clinical negligence �early in 2002�. To date, this paper has not been published. A committee headed by the Chief Medical Officer is consulting widely about the issues and options. clx National Knowledge Service A National Knowledge Service will support the delivery of high quality information for 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 be published 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 building block for the other information the NHS needs in order to monitor quality�. clxiii


122

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 legislation has not yet passed and plans are still being developed:

In relation to revalidation, precise policy is still being developed and the information currently available on this site is intended to give a broad outline of the process of revalidation and what is required. Also, although it is recommended that doctors begin collecting information for revalidation as soon as legislation is passed, they will not be required 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 clinical governance in primary care�. clxv


123

UNITED STATES BACKGROUND Health Care System The U.S. health care system is typically described as an outlier in the Organization for Economic Cooperation and Development. It has the highest level of spending and one of the lowest levels of government spending, although the government at the federal, state, and local levels do provide more than 1/3rd of total health care funding through:

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

• the Medicaid Program (state-level system of insurance for a portion of the indigent 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 health services research through the National Institutes of Health, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. Health care organizations are accredited by the Joint Commission on Accreditation of Healthcare Organizations, providers are licensed by state bodies, and professional qualifications (e.g. specializations) are typically awarded by national colleges. Health care is typically highly managed whether provided by a public or private actor.


124

REPORTS AND STUDIES Harvard Medical Practice Study - 1991 This research, reported in the New England Journal of Medicine, was the first large scale study of the incidence of adverse events in hospitals. The researchers, Lucian Leape, Troyen Brennan and others, based at Harvard University, used chart reviews of 30,195 patients in 51 New York State hospitals to 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. Negligent care was responsible for 28% of all injuries. A two stage screening process was used to derive these rates. Trained nurses or health record technologists using 18 screening criteria first screened the records. If the records met one or more of these criteria, they were then reviewed independently by two physicians who identified adverse events and instances of negligence. In the study an �adverse event� was defined as �an unintended injury that was caused by medical management and that resulted in measurable disability�. Negligence as defined as �failure to meet the standard of care reasonably expected 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 operative events, including wound infections and complications, which comprised about half 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 hospital records in two states, Utah and Colorado, was carried out in the late 1990s. The Utah/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 its report, 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 Health Care project undertaken by the Institute of Medicine, a non-profit organization in the 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 and media savvy summary of the research literature on adverse events (notably the estimate of 44,000 to 98,000 deaths each year as a result of adverse events in


125

US hospitals) and on the prestigious and influential panel that contributed to the report. The overall mandate of the committee was to develop a strategy that would result in 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 one that would capture the interest of the public. Hence this issue was dealt with in a separate publication. Moving beyond a summary of the research evidence, the report offers a view of safety building on the experience of other industries, and the lessons learned by anaesthesia to create safer systems. The report recommendations lay out a national agenda for reducing �errors� in health care and improving patient safety in a four-tiered approach. These include:

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

• identifying and learning from errors through immediate and strong mandatory reporting efforts, as well as the encouragement of voluntary efforts, both with the aim of making sure the system continues to be made safer for patients

• raising the standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers and professional groups; and

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

Among the key recommendations of the report are the establishment of a Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ), focused on setting national goals for patient safety, tracking progress on these goals and developing a research agenda for understanding errors in health care. The most controversial aspect of the report was its embrace of mandatory reporting of adverse events that result in death or serious harm. The report recommended that hospitals and other institutions and ambulatory programs should be required to report such events to an independent body, the National Forum for Health Care Quality Measurement and Reporting. The report simultaneously recommends the development of voluntary reporting efforts assisted by the Center for Patient Safety. To protect institutions and professionals from the impact of such reporting, the committee recommended that Congress pass legislation to extend peer review protections to patient safety and quality improvement data.


126

Other recommendations in the report address the setting of performance standards and expectations for safety and implementing safety systems in health care organizations.


127

Doing What Counts for Patient Safety - 2000 The Quality Interagency Coordination Task Force was created by President Clinton as an umbrella organization coordinating efforts by US federal agencies to improve the quality of health care in America. Following the release of the IOM report, To Err is Human, President Clinton asked the Task Force to conduct a review of the report. The specific mandate of the Task Force was to evaluate the recommendations of the IOM report and to develop a strategy to identify threats to patient safety and ways to reduce health care errors. The QuIC agencies identified a number of key activities that could be undertaken by the federal government to reduce errors, implement a system of public accountability, develop a robust knowledge base about medical errors, and change the culture in health care organizations to promote the recognition of errors and improve patient safety. The report proposed:

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

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

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

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

In addition to mandatory reporting, the QuIC report advocates the development of voluntary reporting systems, the setting of patient safety performance standards and the implementation of medication systems and other methods to improve patient safety. Specific strategies were identified for healthcare organizations, such as veterans and other hospitals administered by federal agencies. 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 practices and rated them in terms of evidence to support more widespread implementation. The results are described below in the �Assessments of Patient Safety Initiatives� section.


128

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 Care in America released its second major report, Crossing the Quality Chasm. The report provides a wide-ranging analysis of the sources of poor quality in US health care and offers a detailed agenda for improving performance. The report begins with a critical overview, based on a detailed assessment of the research literature of the quality problems in US health care. The authors identify the failure to make best use of available resources, the difficulties in translating research advances into practice, the inadequate implementation of information technology, and the failure to develop system approaches to chronic illness care as critical problems for US health care. As an approach for improving performance the report urges the adoption of six aims. Health care should be:

• safe � avoiding injuries to patients from the care that is intended to help them

• effective � proving services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit

• patient-centered � providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions

• timely � reducing waits and sometimes harmful delays for both those who receive 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 care envisioned through the six aims. Instead, the committee argues that there is a need for a new system design, based on �new rules�. These rules would support a system that was designed to meet the needs of patients and to ensure that they are fully informed, retain control and participate in care delivery wherever possible, and receive care that is respectful of their values and preferences. At the same time, the new system should ensure that scientific knowledge about care was available to caregivers. The 10 new rules are:

1. Care based on continuous healing relationships 2. Customization based on patient needs and values 3. The patient as the source of control 4. Shared knowledge and the free flow of information


129

5. Evidence-based decision making 6. Safety as a system property 7. The need for transparency 8. Anticipation of needs 9. Continuous decrease in waste 10. Cooperation among clinicians

To create a new system based on the six aims and the new rules will require transformation 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 improving the quality of health care in America. The issues of patient safety and the reduction of health care errors are critical parts of this analysis, but they are woven 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, including workshops for professionals and educators designed to help translate the report into action.


130

NATIONAL INITIATIVES The US system is typified by a diversity of initiatives. Some of these, such as the National Coordinating Council on Medication Error Reporting and Prevention that started in 1995, represent early privately-initiated responses to research on medical errors. Virtually all of the organizations operating on a national level have coordination of existing initiatives as one of their goals and the support of a voluntary or mandatory reporting system. Although virtually all of these organizations also endorse a culture of safety and the importance of a system-level response, they all also focus on the promulgation of best practices stories that highlight individual or institutional level activity. The US response is also distinguished by its strong focus on adoption of existing patient education initiatives. A number of organizations provide guidance on discussing medical errors with patients and their families and a number of others such as the National Council on Patient Education and Information have rolled patient safety into their mandate. Finally, the US experience can also be characterized by the strong private sector presence and the integration of this presence into government policy (e.g. the National Quality Forum officially launched by then Vice-President Al Gore). The National Patient Safety Foundation (see below) derives strong support from the private sector, while organizations such as Mederror provide a wealth of continuing education materials around patient safety for providers. Targets - 2000 Clinton Administration On February 19, 2000, President Clinton adopted the target set by Institute of Medicine in To Err is Human, namely to reduce medical errors by 50% over five years. 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 error

reduction 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 error

reduction initiatives at Department of Defense and Veterans Administration hospitals

• expanded peer review protections, and • initiated 100 hospital data collection pilot projects


131

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 in healthcare settings

2. Reduce targeted surgical adverse events by 50% 3. Reduce hospitalizations and mortality from respiratory tract infections

among long-term care patients by 50% 4. Reduce targeted antimicrobial-resistant bacterial infections by 50% by:

a. preventing infections; diagnosing and treating infections appropriately;

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 Immunization

Practices) 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 of Health and Human Services and Labour - organized to coordinate Federal Government efforts to reduce error. The stated goal of QuIC is:

� to ensure that all Federal agencies that purchase, provide, study, or regulate health care services are working in a coordinated way toward the common goal of improving the quality of care. The QuIC seeks to provide information to help people make choices, to improve the care purchased and delivered by the Government, and to develop the infrastructure needed to improve the health care system.

Federal Government agencies involved include:

• Agency for Healthcare Research and Quality (lead agency for the federal government and support for research in patient safety)

• Centers for Disease Control (support efforts in infection reduction)

• Healthcare Financing Administration, now the Commission for Medicare Services (error reduction through Peer Review Organizations),


132

• Veterans� Affairs and Department of Defence (error reduction through improved patient care 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 virtually all of them with the exception of those areas where it sees federal-state jurisdictional issues or logistical barriers (such as data collection). Responses and strategies by individual organizations are detailed below. QuIC is linked to the Agency for Healthcare Research and Quality, which is described below. Agency for Healthcare Research and Quality (AHRQ) The AHRQ is the health services research arm of the U.S. Department of Health and Human Services (HHS) and the lead federal organization on patient safety and the chief funding source for research on patient safety. It supported the release of a systematic review of the literature entitled Making Health Care Safer by 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 has focussed on different topics. The most recent one seeks proposals to:

(1) explore the relationship between working conditions that affect health care workers and the safety and quality of care they provide, and

(2) test innovative approaches to working conditions that have been effective in improving the quality of a product or service in other industries. clxvi

It has supported conferences and educational programs and published several documents targeted towards hospitals, providers, researchers, the media, and patients. clxvii The paragraph below outlines AHRQ�s budget and illustrates that patient safety is AHRQ�s top budget priority:

For Fiscal Year (FY) 2003, the President has requested from Congress an appropriation of $251,700,000, a decrease of $48,659,000 (16.2%) from the Agency's FY 2002


133

appropriation. The request provides a $5 million increase for the Secretary's Patient Safety Initiative, maintains funding for several priority programs, provides no new funds for non-patient safety research and training grants, and reflects a $33,754,000 general reduction 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 $50 million for 94 new grants, contracts, and other activities to fund research aimed at reducing medical errors and improving patient safety�. There are six categories of funding:

• Supporting demonstration projects to report medical errors data (24 projects, $24.7 million)

• Using computers and information technology to prevent medical errors (22 projects, $5.3 million)

• 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 assist researchers to interact. AHRQ�s research priorities are:

• the epidemiology of errors � e.g. the types and rates of errors in different health care settings

• the infrastructure to improve patient safety � e.g. needed analytic capacity and organizational culture

• information systems � e.g. development of common definitions of a reporting system and how to evaluate its success; and

• knowing what interventions should be adopted and how to encourage adoption of patient safety practices clxix

The funded projects will be evaluated by the Patient Safety Program Evaluation Center, described below in the �Assessments of Patient Safety Initiatives� section.


134

Veterans Administration (VA) The VA has adopted several approaches to reducing error and promoting safety through its 172 hospitals. VA National Centre for Patient Safety This centre focuses on prevention of error through use of root cause analysis and work based on high reliability organizations. They run a web-based clxx information service that includes information on tips for reducing error, commonly requested resources, and a course of health care failure mode effects analysis and root cause analysis. They also focus very strongly on the development of a culture 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), serving over 11 million patients nationwide, have begun to implement computerized physician order entry systems, proven effective in reducing medical errors. In addition, Veterans Affairs has implemented a computerized medical record in all their 172 hospitals, making it possible to reduce errors by providing complete information about patients at the point of care. Over the past three years, the VA created an error reporting system, established four Centers of Inquiry for Patient Safety, and began to use barcode technology to reduce medication errors� It is also worthwhile noting the VA operates a mandatory error reporting system for adverse events that should soon include a voluntary system that collects 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 all VA hospitals.clxxi

Joint Commission on Accreditation of Healthcare Organizations (JCAHO) The Joint Commission evaluates and accredits more than 17,000 health care organizations and programs in the United States. An independent, not-for-profit organization, JCAHO is the U.S.�s predominant health care standards-setting and accrediting body. The JCAHO has taken a lead in the reporting of patient safety problems and has stated 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 by dissemination strategies and periodic evaluation of initiatives to reduce error. clxxii Although JCAHO provided a reporting mechanism for hospitals for a period of time, this effort has been suspended. It also provides a sentinel event report that


135

describes causes and solutions for sources of error clxxiii and has struck an advisory committee on patient safety. Although patient safety practices have been included in its guidelines for accreditation, application of these standards has also been temporarily suspended. JCAHO�s official involvement in patient safety is its sentinel event policy (the suspended reporting policy that included root cause analysis), the sentinel event alert and other newletters and educational products. Its Office of Quality Management also tracks other quality problems and complaints, and participates in legislative and coalition work to reduce medical error. clxxiv


136

National Patient Safety Foundation - 1997 The National Patient Safety Foundation was established in 1997 by the American Medical Association, CAN HealthPro and 3M. In 1998 the mission of the Foundation was amended to �to improve measurably patient safety in the delivery of health care� through a program that focuses on the systematization and development of new knowledge around error prevention and public and professional advocacy to improve awareness of patient safety issues and support for 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 appropriate direction to researchers. More specifically activities include research grant competitions, awards for best practices in error reduction and communication with the public about safety, consensus programs, and educational conferences and programs. NPSF had a budget of $2.4 million in 2000. Leapfrog Group Comprised of more than 100 public and private organizations that provide health care benefits, the Leapfrog Group works with medical experts throughout the U.S. to identify problems and propose solutions that it believes will improve hospital systems that could break down and harm patients. The group focuses on urban area hospitals. Approximately 32 million health care consumers in all 50 states are covered by Leapfrog employers who include: AT&T, Boeing, DaimlerChrysler, Delta Airlines, Exxon, Ford, General Motors, General Electric, General Mills, 3M, Proctor and Gamble, and Xerox. They spend collectively US$53 billion on health benefits. Leapfrog members use their purchasing power with health plans and health care providers to reward institutions that meet specified standards. For example,

� purchasers will highlight a common set of discrete delivery system improvements likely to yield the largest safety gains ("safety leaps"). These will be earmarked for special visibility in purchasers' interaction with providers, insurers/ administrators, and consumers. For example, purchasers will use common RFP questions to rate the implementation status of the safety leaps for their plans and providers and explicitly integrate such status information 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 have been transformed into the safety standards.

• Computer Physician Order Entry: Physician order entry in hospitals should be computerized. Adverse drug events are the leading cause of avoidable death and


137

disability in American hospitals. As documented in research by Dr. David Bates at Brigham and Women's Hospital, computer physician order entry (CPOE) is a highly effective discrete remedy. In well-managed installations, its costs are likely to be offset substantially by savings from the avoided costs of treating complications.

• Evidence-Based Hospital Referral: Elective treatment should be guided by providers to hospitals and clinical teams with superior outcomes, when valid comparative outcome measurement systems exist. Where outcome comparisons do not exist, such guidance should be based on scientific evidence of volume-outcome relationships. For many treatments, the scientific literature documents significantly superior patient outcomes in hospitals with higher volumes or with teaching programs clxxv

Leapfrog researchers say if the three patient practices are implemented by all non-rural hospitals in the country, 522,000 medical errors a year could be eliminated 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 complex task of improving quality and suggests that a uniform solution will work for every hospital in every community. CPOE, in particular, is not a simple solution. Implementation costs for this customized technology range from $1 million to $20 million per hospital, and that's not counting the significant yearly maintenance and training costs. clxxvi

There is further discussion of Leapfrog in the section below on �Assessments of Patient Safety Initiatives�. MedWatch The U.S. drug and medical device adverse event reporting program is MedWatch:

MedWatch, the FDA Safety Information and Adverse Event Reporting Program, serves both health care professionals and the medical product-using public. We provide important 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, dietary supplements and infant formulas). Medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are quickly disseminated to the medical community and the general public via this web site.


138

Institute for Safe Medication Practices The ISMP works with health care practitioners and institutions, regulatory agencies, professional organizations and the pharmaceutical industry:

ISMP provides an independent review of medication errors that have been voluntarily submitted by practitioners to a national Medication Errors Reporting Program (MERP) operated by the United States Pharmacopeia (USP) in the USA. Information from the reports may be used by USP to impact on drug standards. All information derived from the MERP is shared with the U.S. Food and Drug Administration and pharmaceutical companies whose products are mentioned in reports. clxxvii

ISMP focuses its efforts on improvements in medication labelling distribution, and other delivery characteristics. It also participates in collaborative exercises around patient safety and sponsors forums and other educational activities. It is a non-profit organization and has a national advisory board of practitioners to assist in problem solving.

ISMP is also a key player in much of the American Hospital Association�s efforts to improve patient safety. The AHA website points out that:

In November 1999, the AHA Board of Trustees made improving patient safety a priority and targeted medication safety as its first objective. When the Institute of Medicine released its "To Err is Human" report in December 1999 that shined the national spotlight on 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 hospitals and the people and communities we serve. It goes to the heart of public trust and confidence, both vital to our future.

To provide expertise and leadership to these efforts, the AHA has formed a relationship with the Institute for Safe Medication Practices, the foremost authority on medication safety practices in hospitals and health systems. AHA is also working closely with the Massachusetts Hospital Association and Massachusetts Coalition for the Prevention of Medical 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 the development of policy around patient safety.


139

National Quality Forum The National Quality Forum was launched by the federal government at the same time as Quality Interagency Council with the mandate to reduce error in private 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 delivery of quality services.� clxxix The Forum�s major goals are to:

1. Ensure system-wide capacity to evaluate and report on the quality of care 2. Promote and inform consumer choice and further consumer understanding and use of

quality measures 3. Enable providers to use data to improve performance 4. Allow meaningful quality comparisons of health care providers and plans 5. Promote competition on the quality of health care services 6. Use broad representation to marshal market forces for quality 7. Reduce the burdens on providers and health plans by enabling them to collect consistent

data that avoids duplication.� Its major stated tasks are:

1. Develop a framework based on national aims to coordinate and promote quality measurement and reporting

2. Develop a comprehensive plan for implementing quality measurement, data collection and reporting standards in the public domain to ensure the availability of comparative information on the quality of care that will be furnished by all sectors of the health care industry, 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 and communication plan for use by all stakeholders

5. Plan and promote analysis, use, and dissemination of quality information in a manner that is accessible to the public to enhance consumer choice and quality improvement, and to foster public understanding and use of quality information. Public reporting will be the responsibility of national, regional, and local organizations. The Quality Forum will not be the 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 and rationalize measures development

7. Assess adoption of quality reporting

8. Set a research and development agenda, including definition of priorities for health care improvement and measurement


140

9. Encourage development of health information systems and technology to support quality measurement, reporting, and improvement. clxxx

It recently released reports on error and minorities and several sets of performance measurement indicators. In many cases, the efforts of the Forum are 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 of improving care and lowering health care costs by using technology to enhance patient-provider relationships. PSI reflects the integration of distributed networks management theory with the culture of safety work. It is independent of other organizations concerned with patient safety. The PSI initiatives focus on the development 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 provides real-time, secure, patient-centric clinical information in five key areas that physicians agree are critical for delivering quality care: diagnoses, laboratory results, medications, allergies and immunizations�PSI will offer access to the system through publicly available, open-standard technology. clxxxi

The PSI is supported by several leading, publicly traded information technology companies that have substantial commercial interests in the development of web-based secure data transfer systems. PSI currently has demonstration projects and is in the process of building its board and advisory committees.


141

STATE INITIATIVES A number of initiatives have been launched at the state level. These initiatives generally 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 by reducing the risk of civil disclosure or promoting a systems approach to reducing error. A selection of these initiatives is described below. California A good example of the adoption of the patient safety agenda and coordination of quality improvement activities is the California Institute for Health Systems Performance:

The California Institute for Health Systems Performance (CIHSP) is a non-profit, public benefit corporation charged with expanding the field of performance measurement through the establishment of comprehensive, standardized health care measurement systems. CIHSP is dedicated to the improvement of the health of all Californians by establishing 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 a number of years and has added patient safety to the list of issues it is addressing. It has produced �A Practical Tool Kit for addressing medication errors� that �hospitals can use when considering how best to proceed in choosing and applying a variety of technological solutions, including CPOE, to prevent medication errors in the hospital setting�. clxxxiii It has also produced a primer on physician order entry that �provides an overview on computerized physician order entry (CPOE) systems, which have been shown to reduce medical errors and contain costs. The report describes how CPOE systems work, discusses key features of the systems and the installation process, and provides case studies of hospitals that have implemented CPOE.� clxxxiv Massachusetts

The Massachusetts Coalition for the Prevention of Medical Errors was established in 1998 to develop a campaign in the Commonwealth to improve patient safety and reduce medical errors. A mission statement, structure, and process have been developed and 21 organizations have confirmed their commitment to the coalition�s mission and goals. The goals of the Coalition are to disseminate knowledge and information about the causes of sentinel events and develop strategies for prevention. The Coalition plans to drive improvement by making this information available to health professionals and health care


142

institutions for use in their own quality improvement programs through a statewide campaign. This initiative seeks to strengthen the public�s trust and confidence in the health care delivery system as well, by increasing awareness of error prevention strategies through public and professional education. Additional objectives include providing a forum to promote collaboration among organizations with the common goals of improving care and stimulating a coordinated series of spin-off projects. The formation of the Coalition was a response to the increased focus on medical errors � The evolution of the Coalition is a dynamic and continually changing process. clxxxv

The coalition�s stated goals are of interest because they represent one state�s efforts to develop specific, targeted partnerships. Its stated goals are:

Establish a mechanism to identify and implement best practices to minimize medical errors; increase awareness of error prevention strategies through public and professional education; and identify areas of mutual interest and minimize duplication of regulatory and 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 and promulgation of best practices, but it has also worked in specific and relatively under-addressed areas such as restraint use and ambulatory care. It has also worked towards clear statements around the relationship between institutional and system accountability and patient safety. Minnesota The Minnesota Alliance for Patient Safety provides another example of an umbrella organization. It was founded in 2000 as �a partnership among the Minnesota Hospital and Healthcare Partnership, Minnesota Medical Association, Minnesota Department of Health and more than 50 other public-private health care organizations working together to improve patient safety.� clxxxvi It has a number of standing sub-committees that are addressing critical issues around patient safety programs and legislation including committees on communication and education, best practices, data privacy and measurement. The Alliance also uses 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 statewide organizations with the goal of reducing patient injury from medical error. These organizations 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 patient safety, the PPSC is working to make patient safety a top priority for all stakeholders across the Commonwealth who influence patient care .clxxxvii


143

The collaborative has identified three areas of work focused on best practices, cultural change, and communications and supported this work with focus groups/expert panels and the development of a website and communications strategy including conferences. The collaborative has been very successful in involving hospitals in its work:

An ongoing inventory of safety practices of Pennsylvania healthcare organizations has been conducted with the support of the Pennsylvania peer review organization. Responses have been received from over 70 hospitals outlining 108 safety practices. The best of these will be communicated to the provider community through a series of regional 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 the development of a culture of safety. clxxxviii Rhode Island Rhode Islands� recently formed Quality Institute was originally formed in response to the proposed merger of health plans. The Institute now works towards the improvement of a variety of dimensions of quality including, but not limited to, patient safety:

Rhode Island Attorney General Sheldon Whitehouse has announced the launching of The Rhode Island Quality Institute, which will promote coordination and collaborative relationships, with the intent to make health care safer, reduce waste, and rework the health care system and its incentives for Rhode Island residents. � the Quality Institute is comprised of hospitals, physicians, nurses, business leaders, insurance companies and governmental representatives. At the Whitehouse's direction, the participants have worked to identify key areas of health care that will lead to safer and more cost effective medical 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 Pharmacy Congress. TPSA Chair John Holcomb, M.D., a pulmonary specialist in San Antonio, said that 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 no funded mandates to address the problems, TPSA's only incentive is to do the right thing for patients and to eliminate preventable medical errors. cxc


144

Wisconsin The Madison Patient Safety Collaborative provides an example of local level coordination. Its website notes that, �The Madison Patient Safety Collaborative's primary mission is to provide a structure for area healthcare providers to work collaboratively to develop, share and implement patient safety solutions within the community.� Its most recent activities were summarized as:

The collaborative's most mature initiative focuses on eliminating the use of error-prone abbreviations in prescription drug orders. In June 2001, the MPSC established a workgroup charged with reducing patient falls. Members will design, implement and evaluate a common, targeted intervention designed to prevent the occurrence and harmful outcomes of patient falls. In an effort to involve and inform consumers, the MPSC has also created an educational brochure for consumers regarding safe medication use in various health care locations and the home. cxci

Virginia Virginians Improving Patient Care and Safety is a coalition of almost 50 public and 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 care system safer for patients and the public. You can help too. The single most important way you can help to prevent errors is to be an active member of your health care team. That means taking part in every decision about your health care. Research shows that patients who are more involved with their care tend to get better results. cxcii

This group has produced a book entitled BE INVOLVED IN YOUR HEALTH CARE. Tips to Help Prevent Medical Errors. cxciii The Virginia experience also brings an example of specific legislation to support sharing of data around patient safety (Senate Bill 316) that increases protection from civil disclosure for activities involving analysis of patient safety problems.cxciv


145

ERROR REPORTING SYSTEMS AND DATA ANALYSIS

Although patient safety is the second most important issue driving the development 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. A recent 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 might easily have been prevented with better data and backup from information systems. Since the 1999 Institute of Medicine report that 44,000 to 98,000 people die annually from medical mistakes, concerns about patient safety have been mounting in the medical community and among legislators. Combined with recent horror stories about botched clinical 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 of the licensing process. There has been talk of national legislation aimed at reducing medical 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 as computer 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 can help," says Mitch Morris, an oncologist who runs the clinical practice group at First Consulting Group in Dallas. "They understand this is something they have to pay attention 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. These common findings are:

• error reporting systems that are mandatory should be limited to serious errors

• error reporting systems that are voluntary may take in a number of other types of adverse events and near misses

• error reporting systems should be backed up by techniques such as root cause analysis that allow organizations to identify the causes of those errors

• error reporting system are focusing on hospital care

• error reporting systems should be matched to evaluations of techniques and strategies to reduce error

• error reporting systems and subsequent analyses should not put providers at increased risk of civil prosecution, but these systems should not be allowed to hide negligence or criminal activity by providers.


146

Public and Media Opinion Commonwealth Fund Patient Survey The Commonwealth Fund is a private foundation that supports independent research on health and social issues and makes grants to improve health care practice 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 were included:

Twenty-two percent of respondents reported that they or a family member had experienced a medical error of some kind. Ten percent reported that they or a family member 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 prescription at a pharmacy or while hospitalized. About one-third (33%) of those reporting a prescription error said it occurred while hospitalized. About half (51%) of those experiencing an error at a doctor�s office or hospital reported that the problem was very serious, while 22% of those experiencing a medication error reported 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 one family member� who experienced a mistake in a doctor�s office or hospital or were given the wrong medication or dose. Based on an evaluation of these errors, an estimated 8.1 million households reported the error to be a very serious problem.cxcvi

The authors speculate based on the survey results that the Institute of Medicine�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 the profession: how the news media turned patient safety into a priority� cxcvii analysed media involvement in patient safety issues. The U.S. media did two things 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 dramatic imagery to illustrate the scope of the problem - �Two 747s crashing every three days�. The media also extensively covered the release of To Err is Human and subsequent follow-up reports.


147

REGULATORY, LEGAL AND INSURANCE ISSUES Malpractice Insurance The link between malpractice insurance and patient safety is, of course, that some of the malpractice actions stem from medical errors. The rising costs of malpractice might be reversed in part by effective patient safety programs. Like Australia, the United States is in the midst of a medical malpractice coverage crisis. Costs are rising so dramatically that insurers are leaving the medical malpractice 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 be reaching 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 medical malpractice will generate a 2001 underwriting loss of approximately US$940 million. St. Paul�s 2001 premiums for medical malpractice were approximately $530 million. cxcviii According to the American Hospital Association, insurance carriers are leaving the liability insurance business in large numbers, leaving physicians 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 Hospitals Medical malpractice claims for New Jersey hospitals jumped 250% over the past three years. The average hospital saw its premiums increase from US$373,328 in 1999 to US$942,539 in 2002. Physician liability premiums can reach US$94,000 and higher. Medical liability premiums in Ohio have increased by more than 100% in many areas. The growing premiums are causing doctors to leave their practices, stop performing high-risk procedures, retire early or move in search of lower insurance rates. cci Tort Reform Legislation In April 2002 a bill - the Help Efficient Accessible, Low-cost Timely Health Care Act (HEALTH) - was introduced in Congress. It is designed to curb medical liability insurance premiums and punitive jury awards. The Act would:

• place a $250,000 limit on non-economic damages • limit plaintiff attorney contingency fees


148

• limit the statute of limitations • base damage awards on culpability

However, some congressmen are concerned that even with tort reform, there is no guarantee that high premiums would decrease. The Pennsylvania General Assembly has approved medical liability insurance reform legislation. Among other things, the legislation reduces the amount that hospitals and other providers must pay for malpractice insurance and makes changes to when patients can sue, such as placing a four-year statute of limitation on most suits. Federal Government Position In July 2002 the U.S. Department of Health and Human Services published Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Costs by Fixing our Medical Liability System. It states that �problems have reached crisis proportions� and notes the relationship with incident reporting:

Excessive litigation is impeding efforts to improve quality of care. Hospitals, doctors, and nurses are reluctant to report problems and participate in joint efforts to improve care because they fear being dragged into lawsuits, even if they did nothing wrong. ccii

The federal government estimates that malpractice coverage and defensive medicine 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 of the 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, unlimited compensation for their �economic losses�, including the loss of the ability to provide valuable unpaid services like care for children or a parent

• Ensure that recoveries for non-economic damages could not exceed a reasonable amount ($250,000)

• Reserve punitive damages for cases that justify them�where there is clear and convincing proof that the defendant acted with malicious intent or deliberately failed to avoid unnecessary injury to the patient�and avoid unreasonable awards (anything in excess 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 thus ensure that the money is there for the injured patient when needed

• Ensure that old cases cannot be brought years after an event when medical standards may 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 the claimant 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 as health insurance

• Provide that defendants pay any judgement in proportion to their fault, not on the bsis of how 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 submitted voluntarily to patient safety improvement systems� ccvi was introduced in Congress . The Act would also:

• Recognize the Agency for Healthcare Research and Quality as the leader in patient safety for funding research and for dissemination of information learned 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 being developed

• Recognize that to be effective, these systems must have the buy-in, trust and cooperation of the health care providers ccvii

The American Hospital Association believes that the bill would create a safe environment supporting candid discussion of errors, and encourages caregivers to share medical error information voluntarily. Apparently the bill has the support of the Bush administration. Health and Human Services Secretary Tommy Thompson is quoted as saying that �the tri-partisan bill builds upon the administration's commitment to patient safety�. ccviii A companion bill has been introduced in the House of Representatives.


150

ASSESSMENTS OF PATIENT SAFETY INITIATIVES Making Health Care Safer A Critical Analysis of Patient Safety Practices - 2001 This report by the Agency for Healthcare Research and Quality reported on a project aimed at collecting and reviewing �the existing evidence on practices relevant to improving patient safety�. ccix The report notes:

Readers familiar with the state of evidence regarding quality improvement in 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 the field. 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 because their use is evident to the participants.

• Second, capturing all relevant outcomes, including "near misses"(such as a nurse catching an excessive dosage of a drug just before it is administered to a patient) and actual harm, is often very difficult.

• Third, many effective practices are multidimensional, and sorting out precisely which part of the intervention works is often quite challenging.

• Fourth, many of the patient safety problems that generate the most concern (wrong-site surgery, for example) are uncommon enough that demonstrating the success of a "safety practice" in a statistically meaningful manner with respect to outcomes is all but impossible.

• Finally, establishing firm epidemiologic links between presumed (and accepted) causes and adverse events is critical, and frequently difficult.ccxi

The authors of this study � academics at Stanford and the University of California San 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 perioperative

morbidity and mortality. 3. Use of maximum sterile barriers while placing central intravenous catheters to prevent

infections.


151

4. Appropriate use of antibiotic prophylaxis in surgical patients to prevent perioperative infections.

5. Asking that patients recall and restate what they have been told during the informed consent 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 prevent

complications. 9. Patient self-management for warfarin (Coumadin�) to achieve appropriate outpatient

anticoagulation and prevent complications. 10. Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in

critically ill and surgical patients. 11. Use of antibiotic-impregnated central venous catheters to prevent catheter-related

infections. ccxii

In its conclusion, the authors note that �� this review seeks to plant a seed for future implementation and research by organizing and evaluating the relevant literature�. ccxiii The Challenge of Assessing Patient Safety in America�s Hospitals - 2002 This hospital-funded study set out to define criteria for standards patient safety measures. It appears to be a response to the Leapfrog Group�s incentives related to 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 very significant. 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 to benefit patient safety and quality. Criteria for assessing patient safety would help guide the evaluation of initiatives suggested as potential standards for promoting quality and safety in America�s health care system. ccxiv

The figure below outlines the criteria for standards:


152

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 the UCSF-Stanford group that produced Making Health Care Safer. The results produced below overlap some of the Leapfrog Group�s recommended measures.

Source: The Challenge of Assessing Patient Safety in America�s Hospitals, p. 12


153

One point of disagreement between Leapfrog and the American Hospital Association is the former�s emphasis on urban hospitals and the latter�s position that standards should be applicable to all hospitals. The authors� note:

Although the promise of incentives for hospitals that can successfully implement patient safety programs is certainly an important step toward building better collaboration between purchasers of health care and America�s hospitals, the immediate resources that may be required for some initiatives may be prohibitive for many hospitals, thus precluding the promise of such collaboration. ccxv


154

GAPS Hospital Focus As in Australia, patient safety programs focus almost entirely on hospitals and other institutions. There appears to be little happening regarding drug safety (outside hospitals) or community health care services. Current taxonomies focus on institution-based care. Reporting is Largely Voluntary Current approach to reporting is to support limited state-based mandatory reporting systems. Common elements may make it possible to integrate data in a consistent 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 new efforts, the integration or combination of older efforts, and repackaging of older efforts. In this case, true integration of activities may be impossible, but there are some differences emerging in recommendations, even from organizations like IOM and federal government. Commission But Not Omission Errors of omission focus have received attention in the literature and attention from Medicare, but relatively little attention in terms of documenting or promulgating 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 patient

safety to public • identification of barriers to mandatory and voluntary reporting (including

evaluation of existing reporting systems) • resolution of state-federal jurisdiction issues


155

• development of consistent federal response - e.g. across transfer payment organizations, for example those receiving Medicare, and across government facilities such as VA hospitals

FUTURE PLANS AHRQ Patient Safety Program Evaluation Center Recently the Agency for Healthcare Research and Quality and Research issued a RFP to establish a patient safety program evaluation center. The mandate of the 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 and objects and make recommendations for improvement.

4. Assess overall initiative impacts, outcomes, and adoption diffusion using both qualitative and quantitative assessment approaches.

5. Document and prepare evaluation reports to various audiences and stakeholders indicating the results of AHRQ's funded patient safety research and project activities. ccxvi

The RFP closed on June 7, 2002.


156

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.2 iii 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.26 iv 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. April 1998. 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. i viii Ibid, p. v ix 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 29 xii "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. 135-6 xiii Australian Capital Territory Government, Quality First: a commitment to quality and safety and act health services. p. 5 xiv Australian Health Care Agreements: Annual Performance Report 1998-99, p. 135-6 xv Safety and Quality Council, Action Plan 2001,p. 31 xvi Commonwealth of Australia, Budget 2001-2002, Health Fact Sheet 6: Safer health care xvii Safety and Quality Council, Action Plan 2001, p. 4 xviii Ibid, p. pp. 5-7 xix Safety and Quality Council, Core Standards for Health Care Safety � Consultation Paper, August 2001, p. 5. xx Ibid, p.5 xxi Safety and Quality Council, A Draft Model for Medical Registration August 2001, p. 6. xxii Ibid, p. 6. xxiii Ibid, pages 7 and 9-10 xxiv 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. 2000 xxvi Ibid, p. 4 xxvii Ibid, p. 39 xxviii Ibid, p.41 xxix National Institute of Clinical Studies, Strategic Plan 2001 -- 2004, p.1 xxx Ibid, p.8 xxxi www.health.nsw.gov.au/quality/macqhc.html xxxii Ibid xxxiii www.health.nsw.gov.au/quality/wp/safety.html xxxiv A Framework for Managing the Quality of Health Services in New South Wales. NSW Health, p. 2


157

xxxv Ibid, pp.14-15 xxxvi Ibid, p. 17 xxxvii www.health.nsw.gov.au/quality/history.html xxxviii NSW Health. Quality of Healthcare Indicators Set: Definitions. November 2000 xxxix Victorian Department of Human Services, Clinical Risk Management Strategy 2001 xl www.qualitycouncil.health.vic.gov.au/termsref.htm xli Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.17 xlii http://clinicalrisk.health.vic.gov.au/report.htm xliii Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.12 xliv Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.16 xlv http://clinicalrisk.health.vic.gov.au/limit.htm xlvi Victorian Department of Human Services, Clinical Risk Management Strategy 2001, p.9 xlvii Ibid, p. 10 xlviii Queensland Health, Strategic Plan for Quality: Quality Improvement and Enhancement Program: 1999-2004. Revised Edition October 2000 xlix Ibid, p.6 l Health Department of Western Australia, Strategic Quality Plan Western Australia 1998 8/99 - 2002/3, pages not numbered li Metropolitan Health Services - Annual Report 2000/2001, p.42 lii Ibid, p.42 liii Enduring Solutions, A Patient Safety Plan for the ACT. February 1999, p. v liv Australian Capital Territory Government, Quality First: a commitment to quality and safety and act health services. p. 25 lv Runciman, op.cit., 3 lvi Safety and Quality Council, Safety In Numbers: A Technical Options Paper for a National Approach to the Use of Data for Safer Health Care., p. 4 lvii Ibid, pp, 5-7 lviii Australian Broadcasting Corp., Lateline program, April 30th 2002 lix Commonwealth Department of Health and Aging, The Commonwealth Qualified Privilege Scheme, p.2 lx 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. 2 lxiii Ibid, p. 26 lxiv Ibid, p. xiv lxv Ibid, p. xvii lxvi 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, 2000 lxviii Press release, Commonwealth Minister for Revenue, April 30, 2002. lxix Communique: Ministerial Meeting on Medical Indemnity, April 23, 2002 lxx Ibid lxxi ABC News Online, Panel to review liability, medical indemnity, July 3, 2002. lxxii op. cit., p. 6 lxxiii 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. 17 lxxvii Safety and Quality Council, Core Standards for Health Care, p. 3 lxxviii Oonagh Gay, Devolution and Concordats. House of Commons Library Research Paper 99/84. October 1999, pp. 2-10 lxxix www.nhs.uk/thenhsexplained lxxx Pocket World in Figures, 2002 Edition. The Economist, p. 223


158

lxxxi www.nhs.uk/thenhsexplained lxxxii 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. 1 lxxxiii Ibid, p. 2 lxxxiv Ibid, p.5 lxxxv 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.6 lxxxvi Ibid, p.5 lxxxvii Ibid, pp. vii-viii lxxxviii Ibid, p. 21 lxxxix Ibid, p. 35 xc Ibid, p. 35 xci Ibid, p.37 xcii Ibid, p.46 xciii Ibid, p.54 xciv Ibid, p.70 xcv Ibid, pp. 80-86 xcvi National Health Service, Assuring the Quality of Medical Practice: Implementing Supporting doctors protecting patients, pp. 28-29 xcvii Department of Health, Building a safer NHS for patients: Implementing an organization with a memory, p. 9 xcviii 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. 1-3 c National Health Service, A Commitment to Quality, a Quest for Excellence. June 2001, p. 7 ci op. cit, p.1 cii BRI Inquiry: Final Report, p. 2 ciii Ibid, p. 4 civ Ibid, p.2 cv Ibid, p. 11 cvi Ibid, p.16 cvii Ibid, pp. 450-451 cviii Ibid, p. 442 cix 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. 13 cx Ibid. p. 4 cxi Building a safer NHS for patients, p. 45 cxii p. 46 cxiii Department of Health, Shifting the Balance of Power, The Next Steps, p. 44 cxiv www.doh.gov.uk/clinicalgovernance cxv Nigel Starey, What is clinical governance? Hayward Medical Communications, p.2 cxvi www.chi.nhs.uk/ eng/about/what.shtml cxvii www.chi.nhs.uk/eng/inv/index.shtml cxviii www.chi.nhs.uk/eng/cgr/assessing.shtml cxix CHI, Combined Annual Report and Accounts, 2000-2001, p.25 cxx www.nice.org.uk cxxi Ibid cxxii Ibid cxxiii A First Class Service, Setting quality standards, paragraph 2.34 cxxiv www.doh.gov.uk/nsf/about.htm cxxv NHS Litigation Service, CNST Clinical Risk Management Standards, June 2000 cxxvi National Health Service, Appraisal for consultants working in the NHS, p.5 cxxvii Ibid cxxviii www.doh.gov.uk/gpappraisal


159

cxxix www.ncaa.nhs.uk cxxx NCAA, Corporate Plan 2002-2005, pp. 16-17 cxxxi NCAA, Business Plan 2002-03, p. 25 cxxxii www.npsa.org.uk/ cxxxiii op. cit., p. 59 cxxxiv www.carestandards.org.uk/ cxxxv p. 42 cxxxvi 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. 7-8 cxxxvii Ibid, pp. 9-10 cxxxviii Ibid, p. 33 cxxxix Ibid, p. 42 cxl Ibid, p. 28 cxli National Patient Safety Agency, Pilot Project Evaluation Report, pp. 6-9 cxlii 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 sources cxlv Op. cit., p. 1 cxlvi National Health Service Litigation Authority, Report and Accounts 2001, p. 4 cxlvii Op. cit., p. 451 cxlviii Op. cit., p. 162 cxlix www.doh.gov.uk/clinicalnegligencereform/ cl David Batty, �Bid to cap NHS negligence payouts�, Guardian, August 28, 2001 cli Gaby Hinsliff, �Patients �should not have right to sue��, Guardian, January 13, 2002 clii Op. cit., p. 142 cliii NHS Complaints Procedure National Evaluation, pp. 3-4 cliv Response to Bristol, p. 141 clv National Health Service, Modernising Regulation in the Health Professions: Consultation Document, August 2001, p. 2 clvi NPSA website FAQ page clvii op. cit., p. 442 clviii Learning from Bristol, pp. 3 and 10 clix Ibid, p. 3 clx Ibid, p. 8 and www.doh.gov.uk/clinicalnegligencereform/ clxi Ibid, p. 5 clxii Ibid, p. 12 clxiii Ibid, p. 11 clxiv 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.htm clxix AHRQ Focus on Research. AHRQ Pub. No. 02-MO21, March 2002 clxx 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#D clxxvi AHA Trustee, January 1, 2002 clxxvii http://www.ismp.org/Pages/about.html


160

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.htm cxciii http://www.vipcs.org/patients/index.htm cxciv http://legis.state.va.us/jchc/SD24_2002.pdf cxcv 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. 3-4 cxcvii M.L. Millenson, �Pushing the profession: how the news media turned patient safety into a priority.� Quality and Safety in Health Care 2002; 11: 57-63 cxcviii www2.stpaul.com/spc/corp/spcnews.nsf/ cxcix AHA News Now, June 11, 2002 cc Ibid, June cci Ibid, June 11, 2002 ccii 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. 1 cciii Ibid, p. 7 cciv Ibid, p. 11 ccv Ibid, p. 19 ccvi www.senate.gov~jeffords/press ccvii AHA News Now, June 10, 2002 ccviii Ibid ccix Shojania et al., Making Healthcare Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment No. 42. AHRQ Publication No. 01-E058, Rockville, MD: Agency for Healthcare Research and Quality, July 2001 ccx Ibid, p. 2 ccxi Ibid ccxii Ibid, p. 6 ccxiii Ibid, p. 8 ccxiv Dorothy L. George et al., The Challenge of Assessing Patient Safety in America�s Hospitals. Protocare Sciences. Santa Monica CA. January, 2002 ccxv Ibid, p. 2 ccxvi www.ahrq.gov/fund/rfp02010.htm

2002 gov patient securit e

Documents