ARCHIVED - Governments and Patient Safety in Australia, the United Kingdom and the United States: A Review of Policies, Institutional and Funding Frameworks, and Current Initiatives: Final Report [Health Canada, 2002]

Prepared by J. Paul Gardner, G. Ross Baker, Peter Norton and Adalsteinn D. Brown

Prepared for the Advisory Committee on Health Services
Working Group on Quality of Health Care Services

August 2002

Table of Contents

Introduction

In the United States the Institute of Medicine concluded that medical systems failure is the largest preventable cause of death. In the UK it is estimated that 10% of hospital patients are accidentally injured. The estimated costs of these deaths and injuries range into the billions. It can reasonably be assumed that this problem is extant in all advanced health care systems.

Initiatives to prevent these failures and injuries are most advanced in Australia, the United Kingdom, and the United States.

This paper compares the policies, institutions, and funding the governments in these three countries are using to reduce failures and errors. The appendix describes the major initiatives in each country.

In comparing the patient safety initiatives across the three countries it is, of course, necessary to take into consideration the structure of their health care systems and governments. Federalism in particular is a factor in how patient safety initiatives are delivered.

The health care systems vary considerably in the extent to which there is government direction, funding, and operation. Thus, in order to compare policies or initiatives, it is sometimes necessary to compare a public initiative in one country with a private initiative in another to put government involvement in patient safety in the context of all patient safety initiatives.

The first section outlines the policies governments and their health care partners have adopted. There is a policy consensus across all three countries.

The second section reviews the institutional frameworks being used to develop and deliver patient safety initiatives. Institutions are divided into policy and advisory bodies, and operating agencies. Here there are considerable differences, as might be expected because of different health care and governmental systems.

The third section reports on the funding support governments in the three countries are providing to patient safety initiatives. There are also considerable differences in the amount of support and what is being supported.

Most initiatives are still at an early stage, having been initiated within the last two years. There has as yet been no comprehensive evaluation of these countries' initiatives, but there are a few examples of assessments of clinical initiatives, and the UK has evaluated its pilot incident reporting system.

Policy Frameworks

Definitions of Patient Safety

There is as yet no universally agreed definition of patient safety. Perhaps the most elegant definition is in the U.S. report To Err is Human. It defined patient safety as "freedom from accidental injury". The New South Wales (Australia) definition elaborates on this:

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.[i]

In the Harvard Medical Practice Study an "adverse event" was defined as "an unintended injury that was caused by medical management and that resulted in measurable disability". However, even in the absence of injury there may still have been a "near miss" - a concept borrowed from aviation safety - that should be reported and analysed.

In the U.K. there is has also been discussion of the need for patient safety monitoring to identify not just accidents but also providers whose negligent or intentional acts harm patients.

Incidence Rates

All three countries recognize that there is a significant incidence of patients being injured in their health care systems. The evidence comes from various sources.

1. Reports and Inquiries

The 1991 Harvard Medical Practice Study was the first large-scale study of the incidence of adverse events in hospitals. The researchers 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. 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.[ii] The estimates of the number of deaths annually from adverse events range from 44,000 to 98,000.

The Quality in Australian Health Care Study used the Harvard Medical Practice Study methodology. This 1995 study found an adverse event rate of 16.6% in Australian hospitals. This rate meant 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 a preventable adverse event.[iii] Further analysis of the Australian data designed to make it more comparable to the U.S. methods have reduce the overall incidence to about 13%.

In the UK a report titled An organisation with a memory noted:

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.[iv]

In June 2002 the Chief Medical Officer stated that annually one million hospital patients - one in 10 - will suffer some accidental injury.[v] A pilot study by Charles Vincent in two teaching hospitals using the Australian chart review tools identified an incidence of adverse events of 11% of patients. The Bristol Inquiry estimated that deaths due to adverse events in the UK may be as high as 25,000.

2. Surveys

The Australian Commonwealth Department of Health and Aged Care commissioned a public opinion survey of 1501 Australians. 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 survey notes that the 45-54 age group is most likely to believe that patient safety is becoming worse.[vi]

In the U.S. the Commonwealth Fund released the results of a 2002 survey that included patient safety questions:

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.

Nationally, these reports translate into an estimated 22.8 million people with at least one family member... who experienced a mistake....[vii]

3. Malpractice Costs

The incidence and costs of physician malpractice are an indicator of the rate of patient safety problems despite the fact that the majority of injured patients are not compensated. Costs have been increasing dramatically in all three countries. Australia's largest malpractice organization has recently gone bankrupt. The U.S. Congress is debating legislation designed to reduce malpractice liability costs. In the U.S. average awards for malpractice claims rose 76% from 1996 to 1999.[viii] In the U.K. the total annual cost for settling claims has risen sevenfold since 1995-96. The rate of new claims against specialists rose by 72% between 1990 and 1998. [ixi]

4. Media Responses

The media in all three countries have given extensive coverage to patient safety issues, and in particular to the high incidence rates. Major media organizations such as the New York Times, Wall Street Journal, Philadelphia Inquirer, Boston Globe and CBS have run features on patient safety. Perhaps the most compelling image was used to describe the U.S. death rate from medical errors: "Two 747s crashing every three days". [x]

Governments' Responses

1. Government Leadership

In all three countries, governments responded to the issue by taking a leading role in the development of patient safety initiatives.

In Australia, the national Australian Health Ministers Conference - the senior coordinating body for health policy matters - has been instrumental in developing patient safety initiatives. For example, in 1999 it established the Australian Council for Safety and Quality in Health Care. The Commonwealth (national) government transfers funding to the states/territories for patient safety initiatives and the two levels of government have agreements - described in a later section - that include the following provision:

The Commonwealth and [state/territorial government] agree that there is a need for national commitment, in partnership with clinicians and consumers, to healthcare safety and quality improvement and recognize that there are some safety and quality issues which are best dealt with at the national level. [xi]

Australian state and territorial governments are also taking a leading role. All states have patient safety strategies and Quality Councils that have a mandate to further patient safety initiatives. Some states have a branch of the health ministry managing patient safety.

In the United Kingdom, the most important patient safety official is the Chief Medical Officer of the Department of Health. Many reports and consultation papers are issued from his office. In 2001 alone, seven major government reports on patient safety were published. The UK government has developed and funded five new agencies that include patient safety in their mandates.

In the United States, President Clinton gave patient safety a very high profile when he responded to the Institute of Medicine's report To Err is Human. A coordinating body - the Quality Interagency Council (QuIC) - has worked to develop the response of federal agencies to patient safety. and In addition, the Agency for Health Care Research And Quality (AHRQ) has played a leading role in the development of patient safety research and related initiatives. To cover the private health care sector, the government-sponsored National Quality Forum has also helped to coordinate some patient safety related activities through its role in developing and implementing a national strategy for health care quality measurement and reporting.

2. Targets and Goals for Error Reduction

The Australian Safety and Quality Council's Action Plan has established 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 [xii]

In June 2000, the UK government set four specific targets:

  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. [xiii]

In addition to these four targets other high-risk areas of clinical practice are being identified so that further early-targeted action can be considered where appropriate. 'Cross-cutting' initiatives have been identified where introducing a focus on safety could lead to risk reduction. These include:

  • reviewing the safety environment - identifying changes in care practices that could reduce risk and improve patient safety
  • reviewing clinical practice - in conjunction with Royal Colleges, professional organisations and specialist associations to identify high risk procedures
  • purchasing for safety - addressing safety as part of buying policy throughout the NHS
  • design for safety - seeking input from the world of design to identify previously unrecognised opportunities for improved safety
  • computers to reduce error - examining across a broad field the potential for computers to reduce the occurrence and impact of error
  • safety briefings - identifying the scope for formal 'pre-procedure' safety briefings in a selected number of high risk clinical situations
  • risk simulation - enhancing the capacity for staff to be exposed to and handle risk in simulation laboratories
  • patients' role in safety - examining comprehensively the potential for patients themselves to help to promote and achieve safety goals.

In the United States, President Clinton adopted the targets set by the Institute of Medicine to reduce medical errors by 50% over five years. Specifically, the Centers for Disease Control and Prevention set seven challenges that are linked to this 50% reduction target:

  1. Reduce catheter-associated adverse events by 50% among patients in health care 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 health care personnel
  7. Achieve 100% adherence to ACIP (Advisory Committee on Immunization Practices) guidelines for immunization of health care personnel

In July 2002 the U.S. Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced six goals to be achieved through accreditation and related activities:

  1. Improve the accuracy of patient identification
  2. Improve the effectiveness of communication among caregivers
  3. Improve the safety of using high-alert medications
  4. Eliminate wrong-site, wrong patient and wrong-procedure surgery
  5. Improve the safety of using infusion pumps
  6. Improve the effectiveness of clinical alarm systems [xiv]

JCAHO expects to issue National Patient Safety Goals and Recommendations each year and will make aggregate data on achievement of the goals public each year.

3. Research

All the governments recognize that much research is required to improve patient safety. The United States leads research efforts because of its major research funding commitment - US$50 million. Virtually all of U.S. federal funding is committed to research and demonstration projects, with half of it related to incident reporting system research.

The UK has committed £2.5 million to patient safety research. The Department of Health's Research and Development Directorate is targeting funding to:

  • build research infrastructure e.g. by helping to establish centres of excellence, and/or networks of centres and research units
  • build capability e.g. by promoting research that is multi-disciplinary, by investing in postgraduate training and/or research programmes
  • establish themed programmes of related projects
4. Funding and Institutions

Later sections deal with government funding provided for patient safety initiatives and institutions that were established at government behest to deliver patient safety programs. It is important to note that in Australia and the UK - both of which have largely publicly funded health care services - virtually all the patient safety initiatives are government controlled, government sponsored, government funded, and accountable to government.

In the United States, the situation is different. The Leapfrog Group is a good example of how private sector health care purchasing has become instrumental in implementing hospital patient safety initiatives. The Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) initiatives in patient safety are funded by the accreditation fees paid by health care organizations.

Policy Assumptions about Patient Safety

Across the three jurisdictions there is a commonality in policy assumptions.

1. Significant hidden costs of doing nothing

The Australian Patient Safety Foundation notes that the cost of adverse events exceeds AUS$2 billion per year. The Task Force on Quality in Australian Health Care in 1996 estimated that preventable adverse events were costing the Australian health care system an estimated $867 million per year - 1.7 million bed days. The $867 million did not include litigation costs, settlement costs, ongoing disability costs, or loss of productivity.

As previously noted, in the UK adverse events are estimated to cost at least £2 billion per year. In addition,

The NHS pays out around £400 million a year settlement of clinical negligence claims, and has a potential liability of around £2.6 billion for existing and expected claims [xv]

In the U.S. To Err is Human estimated the annual cost of medical errors as $37.6 billion, with about $17 billion deemed preventable with half - $8.5 billion - being for direct health care costs. These estimates are based on varying assumptions that prevent direct comparison, but are notable for their large scale.

2. Relationship Between Quality and Safety

In the United States and Australia, patient safety is an integral part of efforts to improve the quality of health care. As one Australian report put it, "There is a strong correlation between safety and quality - diminished standards of safety reflect poor quality service". [xvi] In the United States, the Quality Interagency Council (QuIC) has worked to coordinate federal government responses in the patient safety effort, and in Australia it is the Safety and Quality Council that has the major role in coordinating activities. These examples suggest that the boundaries between safety and quality efforts are often difficult to establish. It is also difficult to disaggregate safety funding from quality funding.

Initially patient safety efforts appear to have been regarded as a subsidiary effort to quality. However, in recent years patient safety efforts have become a primary focus, and are seen as a necessary condition for any effective quality program. For example, this year's U.S. federal budget reduced the budget of QuIC but increased the allocation for patient safety.

The New South Wales Framework states that, "Quality oriented health service [includes] an emphasis on preventing adverse outcomes through simplifying and improving the processes of care."

In the UK more emphasis has been placed on patient safety outside of a quality context. This is perhaps the result of patient safety initiatives emerging from highly publicized "scandalous" incidents such as those at the Bristol Infirmary that have required that the NHS acknowledge the need to improve oversight of clinical activities. Some processes and institutions such as the National Patient Safety Authority are dedicated to patient safety while others such as the Commission for Health Improvement have a role in both patient safety and quality initiatives.

In all three jurisdictions, there would be no disagreement about the closeness of the links between patient safety and quality; however, the relationship between patient safety efforts and more general quality improvement initiatives is still evolving.

3. Systems approach - detect and prevent patterns of errors

A model often cited by patient safety advocates is the airline industry's successful efforts to improve aviation safety. In the United States, for example, the aviation industry reduced its accident rate by two-thirds between 1950 and 1990.[xvii] This was accomplished by making safety a priority, by looking for systems explanations for mistakes instead of blaming individuals, and by instituting an industry-wide error reporting system.

A good summation of a systems approach to health care is found in the UK report An organisation with a memory:

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. [xviii]

There is also a corollary concept that systems need to be designed to overcome human deficiencies:

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 [xix]

4. Culture change - don't blame individuals

The systems logic extends to the notion that in order to identify systems problems, the problems must be identified and reported. Moreover, the organizational culture must encourage reporting. The current culture in health care organizations discourages identifying and reporting errors. The reasons for this include: fear of litigation; fear of discipline or colleagues' disfavour; and the human predisposition to avoid admitting having made a mistake.

The policies of all three countries are premised on the need for significant change in the thinking and behaviour of health care providers and health care institutions about the causes of medical errors and how to prevent them. Culture change is one of the key concepts in all three countries.

New South Wales, for example, postponed the introduction of its incident reporting system in order to persuade providers and institutions about the benefits of the system and increase the acceptability of reporting incidents.

Another aspect of culture change is reinforcing the concept that anyone can make a mistake and that there should be no penalty for doing so. The quotes below from three different reports illustrate this:

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. [xx]

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. [xxi]

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. [xxii]

5. Reporting systems for errors and near-misses

All three countries have or are developing national or state-level incident reporting agencies. These are described in more detail in the next section. The policy rationale for reporting systems is well described in the UK report An organisation with a memory:

  • 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. [xxiii]

A reporting system in Western Australia described its purpose as follows:

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.

There has been considerable debate about whether reporting of incidents should be voluntary or mandatory. The UK will likely be the first jurisdiction to have a national and mandatory reporting system. Australia is in the process of developing a national system based on the aggregation of state systems; it is not yet clear whether this system will be mandatory nationally or just in several states. In the U.S. there have been several Congressional hearings on the benefits and disadvantages of different approaches to reporting and several bills proposed, none of which have been passed through Congress. The Joint Commission has a voluntary sentinel events reporting system for hospitals, but it has had difficulty in using this information effectively.

6. Root Cause Analysis

Obtaining incident report data is just the first step. In the three countries there is recognition that root cause analysis of serious incidents is essential.

The cornerstone of the requirements ... 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 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.... [xxiv]

All three countries are making significant investments in root cause analysis. For example, in the UK the National Patient Safety Agency is dedicated to incident reporting and root cause analysis. In the State of Victoria there is a Root Cause Analysis and Risk Reduction Action Plan. In the United States the Veterans Administration's National Center for Patient Safety uses root cause analysis to analyze adverse events and design ways to prevent incidents reoccurring.

Root cause analysis is often done both locally at the site of the incident, regionally (in the UK) and by a national agency looking for patterns. A key challenge is finding ways to share the results of root cause analysis between organizations.

7. Feedback to Providers and Institutions

Providers and institutions need to see the benefits of participating in incident reporting and root cause analysis systems. The obvious benefit is that they get to share the experiences of others, giving them the potential to avoid accidents that happened to the others.

In the UK the National Patient Safety Agency has a mandate to "collect reports from throughout the country and initiate preventative measures, so the whole country can learn from each case, and patient safety throughout the whole NHS will be improved every time". The Veterans Administration in the United States operates a web site to disseminate root cause analysis findings.

The findings are also of use to the standard-setting organizations such as the National Institute of Clinical Studies in Australia and the National Institute for Clinical Excellence in the UK.

8. Patient Involvement and Complaints

By being better informed about their health care, patients may be able to prevent errors. For example, patients may be able to spot a prescribing or dispensing error by being familiar with medications appropriate for their condition.

In almost every Australian patient safety process there is a commitment to patient involvement. The National Expert Advisory Group's first "national action" was to "support methods to enable increased consumer participation in health care". The Australian National Strategy's first point is to enhance "Consumer/Community Involvement in Decision Making". The Safety and Quality Council's priorities include "Actively promoting opportunities for consumer feedback and participation".

In Australia and the UK patient complaints are viewed as important sources of information about patient safety and quality. The mechanisms used are described in a section below.

One U.S. observer noted that the strong consumer focus of the patient safety movement has been a critical success factor, allowing groups such as Leapfrog to be successful in demanding institutions to implement patient safety measures.

In the United States, the National Patient Safety Foundation has undertaken concerted efforts to involve patients in providing feedback about ways to improve care.

9. Need for Malpractice Reform: Cost and Disclosure

There are three factors driving malpractice reform: crises in the cost and availability of coverage; the conflict between the need for culture change and the litigious tradition as it relates to disclosure; and the inefficiency of tort proceedings as a mechanism for improving practitioner behaviours and organizational practices.

Some malpractice actions stem from medical errors. The rising costs of malpractice might be reversed in part by effective patient safety programs. All three countries are currently dealing with crisis situations in the availability and cost of malpractice coverage for physicians and institutions. All three countries have legislative reform processes underway.

Patient safety first captured the Australian government's attention in the early 1990s because of concerns about malpractice coverage. Currently there is a crisis, with the organization having 73% of the market going out of business in April 2002. United Medical Protection - similar to the Canadian Medical Protective Association - represented more than 40,000 of Australia's 55,000 doctors. This forced the Commonwealth government to guarantee coverage to physicians.

In a communiqué on guaranteeing coverage, the Australian and state Ministers 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.

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. [xxv]

In July 2002 the Commonwealth government announced a review of medical indemnity issues chaired by a Supreme couCourt judge.

The UK also has rapidly escalating malpractice costs that are of concern to the government. As noted earlier, malpractice claims have risen sevenfold since 1995-96. The estimated net present value of outstanding claims was £2.6 billion in March 2000. The UK is concerned about the possibility that a litigious malpractice environment might inhibit the culture change necessary to operate effective patient safety programs. The Bristol Inquiry 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. [xxvi]

In its response to the Bristol Inquiry, the government said:

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. [xxvii]

In the consultation document for the preparation of the White Paper, the Chief Medical Officer asked for comments on two alternative schemes:

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?

What would be the potential benefits and dis-benefits in introducing a system of fixed tariffs for specific injuries?

The White Paper has not yet been published.

The United States is also 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. 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, limit the statute of limitations, and base damage awards on culpability.

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. This report, in support of the HEALTH bill, states:

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. [xxviii]

According to many experts, the #1 barrier to more effective quality improvement systems in health care organizations is fear of creating new avenues of liability by conducting earnest analyses of how health care can be improved. [xxix]

The report also cites a study that concluded, "Tort law's overly emotional and individualized approach...has been a tragic failure". [xxx]

Institutional Frameworks

Policy Making and Advisory Bodies

1. Political Direction

In each country senior policymakers have been involved in the development of patient safety initiatives. This differs from country to country.

In the United States, President Clinton endorsed the findings of the Institute of Medicines study To Err is Human, creating the Quality Interagency Coordination Task Force to develop the government response. In Australia, the Australian Health Ministers Conference is the directing body of patient safety efforts. In the UK, the Minister of Health takes the political lead.

2. National Policy Development and Advisory Bodies

Each country then has a differing structure for providing advice to government about patient safety initiatives.

In Australia, the senior advisory body is the Australian Safety and Quality Council. The Council, established in 2000, has 22 members, most of whom are medical academics or heads of patient safety programs. It provides advice, develops national action plans, negotiates funding with governments, and provides frequent reports to the Ministers of Health and the public. With both national and state representation, the Council develops standards in cooperation with state officials with a view to making the standards national.

In the United States, the Quality Interagency Coordination Task Force (QuIC) has a mandate to coordinate Federal Government efforts to reduce medical error. Initially it was chaired by the Secretaries of Health and Labor, with the membership drawn from 11 federal government agencies. The Bush administration has been less supportive of these activities than the previous Clinton administration. The government-sponsored National Quality Forum through its mandate to develop quality reporting, attempts to coordinate patient safety efforts in private health care.

In the United Kingdom, there is no policy advisory body. The Bristol Inquiry recommended the establishment of a Council for the Quality of Health Care, but the government has not committed itself to establishing it.

3. State-Level Policy Development, Advisory and Coordinating Bodies

Australian state and territorial governments have under a variety of names "Quality Councils" that have responsibility for patient safety initiatives. Under the Australian Health Funding Agreements, states and territories are obliged to have strategic plans that incorporate patient safety initiatives. All these councils are advisory, dealing with matters such as evaluation of patient safety programs, review of strategies, and liaison with the national Safety and Quality Council.

Because of the early stage of devolution in Britain, Wales and Scotland have not yet developed their own patient safety structures. England essentially remains a unitary state governed by the parliament at Westminster with the National Health Service and the Department of Health playing a national role. Wales adopts many of England's patient safety initiatives while Scotland has adopted a few.

In the United States, the pattern is for state provider associations to band together to form patient safety coalitions. (See appendix for examples.) Typically, these coalitions would include the associations representing hospitals, physicians, nurses, pharmacists and health consumers. In some cases these coalitions have state government representation. In addition, the state-level Quality Improvement Organizations (QIOs) created by the federal Centers for Medicare and Medicaid Services from the former Peer Review Organizations have adopted some oversight responsibility for patient safety in Medicare and Medicaid activities.

4. Government Administrative Oversight

In Australia, government-run patient safety initiatives are all at the state level. As described below, the Commonwealth government provides transfer payment funding for patient safety initiatives but does not operate any itself.

The larger Australian states have Quality Branches in their departments of health that oversee patient safety funding and programming. The directors of these branches sit on a State Quality Officials Forum, a body that advises the Safety and Quality Council.

In the United Kingdom, patient safety efforts are lead at the administrative level by the Chief Medical Officer of the Department of Health.

Because of the nature of its health care system and because of conflicts between sponsors of different legislative initiatives, the United States federal government does not have any agency that administers nationally-mandated patient safety initiatives.

5. Private Sector Organizations

In Australia and the United States there are significant private sector national organizations involved in patient safety. These private sector organizations in most cases preceded the establishment of government-sponsored institutions. Several have been selected and described below to illustrate the role they play and how in a very real sense they facilitated the establishment of public sector initiatives by initially raising the public profile of patient safety issues.

The Australian Patient Safety Foundation (APSF) was founded in 1989. 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. APSF initially arose to address anaesthesia safety issues. Its main focus has become the Australian Incident Monitoring System (AIMS), Australia's first voluntary monitoring system.

The U.S National Patient Safety Foundation was established in 1997 by the American Medical Association with support from several foundations and corporations. Its mission is 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, and to ensure uptake of research.

The U.S. Leapfrog Group, comprised of more than 100 public and private organizations that provide health care benefits, 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. 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.

The U.S. Patient Safety Institute (PSI) is a collaborative initiative involving a number of technology and other for profit enterprises with the goals of improving care and lowering health care costs by using technology to enhance patient-provider relationships. PSI initiatives focus on the development of low-cost information technology-driven solutions to patient safety problems.

6. Local Advisory or Governing Bodies

New South Wales has 17 Area Quality Councils that are committees of the Area Health Service Boards, the operating agencies. The purpose of the Councils is 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." The Area Councils also provide reports and recommendations to the state's Council on Quality in Health Care. Each area has a Patient Safety Officer provided by the state government to run the developing incident reporting system.

The UK government introduced clinical governance in 1998. In the UK, "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." [xxxi]

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. [xxxii]

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 [xxxiii]

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

The Veteran's Administration in the US has established four Patient Safety Centers that provide assistance and training to VA health facilities in developing patient safety activities.

Operating Agencies

1. Incident Reporting Agencies

Incident reporting systems can be compared on the basis of whether they are

  • National, state, or local
  • Voluntary or mandatory
  • Reporting sentinel[1] events only, other injuries, or "near-misses"
  • Using the results locally only or reporting them to a regional or national authority
  • Covering hospitals only or also including primary care
Incident Reporting Systems
Jurisdiction Agency Date Started or Starting Voluntary/
Mandatory
Coverage Type of Incidents Report Goes To
Australia: National Australian Patient Safety Foundation - AIMS 1994 Voluntary Hospitals Did or could have caused harm  
Australia: Victoria State Government 2002 Mandatory Hospitals Adverse Events, Near Misses Aggregate to State Government
Australia: Victoria State Government 2001 Mandatory Hospitals Sentinel Events State Government in 5 days
Australia: Western Metropolitan Health Services 2001 Mandatory Hospital Network   Local
United Kingdom National Patient Safety Agency 2002(in pilot) Mandatory National - hospitals & primary care All incidents, even if no harm NPSA
United States: National Joint Commission on Accreditation of Healthcare Organizations   Voluntary Hospitals Sentinel Events JCAHO
United States: National Veterans Administration 1999 Mandatory VA Hospitals All incidents - voluntary for near misses VA
United States: State Various States e.g. New York   Mandatory All Hospitals Sentinel Events State Government

There are several other Australian state initiatives being developed that are not included in the table. (See appendix for details.) States are also discussing the possibility of mandating the use of the AIMS system nation-wide.

Experience in other jurisdictions suggest that there are several issues that can be anticipated in the development of any reporting system:

  • Culture Change: as discussed previously cultural change is a necessary condition for the success of any reporting system
  • Legal: providers and institutions must be satisfied that reports of incidents made in good faith will not have adverse medico-legal consequences. Protection of information against discovery may be necessary to encourage reporting
  • Scope of Incident Coverage and Ensuing Volume: is the system to report sentinel events only, events with injuries, near misses, or all of them? The wider the definitional net for incidents, the greater the volume of reports. The system must be scaled to receive and analyse all reports; otherwise, the reporters will lose faith in the system
  • Voluntary or Mandatory: government systems are always mandatory (because of course only governments can mandate) and private initiatives are voluntary. In some cases private initiatives, such as hospital accreditation in the U.S. may become quasi-mandatory because of the requirement that facilities that receive federal Medicare funding be accredited
  • Acute Care Hospitals Only or Also Primary Care, Long-term Care, and Community Care: most of the reporting systems encompass hospitals only, the one major exception being the UK NPSA system that intends in the future to cover primary-care as well
  • Resources - locally and centrally: local hospitals and other contributors must have trained staff to administer the system and train others; the central agency receiving the data must be able to receive the data and communicate effectively with the contributors
  • IT Issues: new reporting system should be computerized for ease of access, submission and speed of transmission for the reporting entity and receipt by the central agency. However, as the UK discovered, this means challenges in integrating various existing systems and platforms into a functional system
  • Coding: in order to detect the underlying patterns of incidents they must be uniformly coded locally (for accuracy); this requires agreement on the coding system to be used and local training in its use
  • Training: all health care providers must be trained (and acculturated) about the system and how they should use it. A small cadre of devotees is not enough to ensure success Who Gets the Reports: the raw data and the subsequent root cause analysis conclusions can be limited to local access, or forwarded to a regional authority, or possibly sent on to a national authority
  • When Reports are Submitted: mandatory reporting can be required in a matter of a few days in the case of Sentinel events, or be incorporated into an institution's annual report in the case of less serious events
  • Anonymity: protecting patient and provider identities is certainly the norm, but in some systems (e.g. NPSA in the UK) the possibility is left open to share the information with other authorities such as public health or the police, depending on the nature of the event

Incident reporting is by no means a mature process. The system in the United Kingdom and state systems in Australia are still in development. The UK National Patient Safety Agency (NPSA) recently announced the results of a pilot project that enhanced capture and analysis of incidents in 40 NHS Trusts. NPSA experienced difficulties with setting up systems in primary care and mental health but results showed about 10% of those patients in acute care hospitals experience adverse events and identified clusters appearing in acute care. The earliest system - Australia's AIM - continues to be enhanced. The VA Health System in the US has implemented a system based on the aviation reporting system. The Agency for Health Research and Quality (AHRQ) in the U.S. is spending US$25 million to research reporting systems. Thus, it is premature to pass judgment on the effectiveness of any system.

2. Root Cause Analysis Systems and Results Reporting

All of the reporting systems in the table above have root cause analysis built into them. In most systems, the root cause analysis is done locally and forwarded to a central authority. The central authority then has the responsibility to look for patterns emerging within the database, and where a pattern is detected to inform the health care community and the public of the newly identified risk.

3. Institutional Assessment/Review/Accreditation

In all three countries there is a link between institutional assessment /reviews/accreditation and patient safety and quality initiatives. The assumption is that patient safety and quality can be assured to some extent by an accreditation or review process that reviews policies, procedures and resources related to patient safety and quality initiatives.

There are, however, differences in how this is done. The UK takes a governmental approach and Australia and the United States take a nongovernmental approach.

The UK has the Commission for Health Improvement[2] devoted to assessing trusts' safety and quality performance - Clinical Governance Reviews - on a four-year cycle. It been operating since 1999 and also has a mandate to investigate systemic failures. CHI is a government-sponsored and funded institution with authority to conduct these investigations and reviews and make its findings public. It also monitors local and national implementation of national clinical guidelines.

The Australians do not have a comparable body, but the Safety and Quality Council is undertaking a review of the institutional accreditation process. In a discussion paper the Council states that accreditation does not currently equal an assurance that health care is being provided safely in the accredited setting. The Council intends to develop "core safety standards" for use by accreditation agencies. The Australians may introduce a system of competitive accreditation agencies on a model similar to that of hiring outside auditors.

In the United States the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accredits more than 17,000 health care organizations and programs. The JCAHO has developed patient safety standards that are incorporated in its hospital accreditation process:

In July 2001, additional patient safety standards went into effect for hospitals. These standards address a number of significant patient safety issues including the implementation of patient safety programs; the responsibility of organization leadership to create a culture of safety; the prevention of medical errors through the prospective analysis and re-design of vulnerable patient systems (e.g. the ordering, preparation and dispensing of medications); and the hospital's responsibility to tell a patient if he or she has been harmed by the care provided. JCAHO is considering implementing similar patient safety standards throughout its accreditation programs.... About 50 percent of JCAHO standards are directly related to safety, with additional standards indirectly related to safety.

Purchasers in the US are developing standards that may serve as a de facto form of accreditation. The Leapfrog Group, composed of Fortune 100 companies, uses its combined purchasing power with health plans and health care providers to reward institutions that meet specified standards. Its initial standards include whether a hospital has computer physician order entry systems, evidence-based hospital referral, and 24/7 availability of critical-care certified physicians in ICUs. Hospitals with these capabilities are given a higher score during RFP evaluations.

4. Individual Provider Assessment

The UK is unique in having a system to appraise every physician working in the National Health Service every year. This system started in 2001 for specialists and 2002 for family physicians. A peer physician trained as an appraiser performs the appraisal. The process is designed to give physicians feedback on their past performance and to identify developmental needs. However, if an appraiser perceives a physician is putting patients at risk, appropriate action is taken by the employer.

One of the appropriate actions would be to refer the physician to the new National Clinical Assessment Authority. The NCAA can either provide advice to a local authority or perform a full assessment. Its reports are confidential, except when a statutory power to require information is invoked, such as by the General Medical Council.

5. Clinical Guideline Setting and Dissemination

Governments recognize that clinical guidelines contribute substantially to patient safety and quality. Governments in all three countries have funded national clinical guideline institutions.

All three institutions disseminate guidelines and fund guideline research. The U.S. and UK institutions develop guidelines; the Australian one uses guidelines from other sources.

The Australian National Institute of Clinical Studies (NICS) has a mandate to close the gaps between evidence and clinical practice and to facilitate cultural change in clinical practice. It does not develop clinical standards itself, but identifies them and informs the Australian health care community.

The UK's National Institute for Clinical Excellence (NICE) provides patients, health professionals and the public with "reliable guidance on current best practice". It has a mandate to develop clinical guidelines - it has published five and has 31 others in preparation. Physicians "are expected to take the guidance fully into account when exercising their clinical judgment". NICE is also developing clinical audit tools for use by health professionals to monitor how well its guidelines are being followed. NICE also advises the government about which procedures, pharmaceuticals and technologies should be paid for by the NHS.

The U.S. Agency for Healthcare Research and Quality (AHRQ) sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decision-makers-patients and clinicians, health system leaders, purchasers, and policymakers-make more informed decisions and improve the quality of health care services. AHRQ also operates the National Guideline Clearinghouse.

Of the three institutions the UK NICE has the broadest role and the most authority, in part because of its direct links to the NHS and in part because it is more directive in relation to funding and compliance.

6. Professional Governing Bodies' Role

In the United States and Australia, professional governing bodies are creatures of the states and territories. In the UK they are organized nationally. No evidence was found in any of the three countries of any governing professional body playing any significant role in patient safety initiatives.

In Australia governing bodies are not represented on state or national quality and safety councils. No governing body publications or statements about patient safety or quality were found.

In the UK, the professional governing bodies are undergoing reform. The Bristol Inquiry noted weaknesses in the current regulatory bodies and recommended that there be more effective coordination of their work and clearer accountability mechanisms. This fall parliament will consider the National Health Services Reform and Health Care Professions Bill that contains a Council for the Regulation of Health Care Professionals. The Council would have the authority to investigate and report on the performance of each regulatory body, and direct the regulatory body to make rules, regulations, bylaws and schemes, and to appeal any regulatory body disciplinary decision it considers too lenient.

The General Medical Council is considering a re-evaluation scheme for physicians but this appears to be several years away. It is noteworthy that the GMC is responding less quickly compared to the government in establishing new programs to address patient safety issues.

However, the General Medical Council, along with other senior medical organizations, has endorsed the government's patient safety initiatives in a joint statement entitled A Commitment to Quality, A Quest for Excellence.

In the U.S., many patient safety initiatives are organized at the national level, thus possibly excluding any significant state regulatory presence. However, patient safety initiatives at the state level seem to include voluntary professional associations but exclude professional regulators.

7. Patient Involvement and Complaints

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 with a broad mandate to investigate complaints against individual providers, hospitals and any other public or private facility where care is provided, as well as unregulated providers. These commissions may refer a matter to a professional disciplinary body and prosecute the complaint before the disciplinary body. The commissions have 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 a 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 [xxxiv]

In the UK the NHS has a formalized complaints procedure at the local level with a higher-level independent review. A recent review of this process has prompted the government to introduce reforms. The reforms include 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.[xxxv] In the UK the government is committed to providing more information to patients. In the future data on the performance of consultants and their units/teams will be published for the use of both clinicians and patients.[xxxvi] A National Knowledge Service will support the delivery of high quality information for patients and staff. [xxxvii]

In the U.S. there appears to be no national mechanism to use patient complaints as a means of identifying system failures and errors. However, a number of large systems, including the Veterans Administration and for-profit health systems have developed mechanisms for collecting patient complaints.

Funding Frameworks

Australia

Australia funds patient safety and quality initiatives with both Commonwealth (federal) funding and state/territorial funds. These funds are then flowed to health care programs and patient safety and quality initiatives.

1. Commonwealth Funding
Transfer Payments to States and Territories

The Commonwealth government contributes to healthcare funding. The breakdown of health expenditure is: Commonwealth government, 47%; state/territorial governments, 23%; and non-government, 30%.[xxxviii] Commonwealth funds are transferred to state/territorial governments on the basis of a new mechanism, Australian Health Care Agreements (AHCA). The first agreements cover the period from July 1, 1998 to June 30, 2003.

The agreements cover more than just funding for services, and include a section on "Quality Improvement and Enhancement". They specify that Commonwealth funds can be allocated to states and territories to support quality improvement programs.

The Commonwealth government has allocated approximately AUS$660 million across Australia over the five years for quality and safety initiatives.[xxxix] The funding is allocated on a population basis.

Organizational Funding - Safety and Quality Council

The Commonwealth Government funds the national Safety and Quality Council. The 2001-2002 budget allocated $22 million over four years. State and territorial governments have committed a further $33 million over five years to the Council. The table below breaks down the Council's expenditure plan.

Quality and Safety Council 5 Year Budget
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
2. State Funding
Transfers to Programs and Institutions

Most states and territories flow the Australian Health Care Agreement quality and safety funding directly to their regional health authorities who are supposed to spend the funds on quality and safety initiatives. However, the accountability mechanisms between the two levels of government and between the state/territorial governments and their regional health authorities in relation to the safety and quality funds are weak. It is not possible to separate safety from quality, but Australian officials say that safety initiatives are being highlighted.

Some states have AHCA-funded programs. Victoria - with a population of 4.8 million - has a "quality bonus" program of $43.5 million that is putting in place quality and safety systems. There is another $33 million allocated to 43 quality projects that relate to access indicators.

Queensland - with a population of 3.6 million - has earmarked $23 million of its AHCA funding specifically for patient safety initiatives.

The negotiations for the renewal of the AHCA are beginning, and state patient safety officials are proposing better accountability for the safety and quality funding.

Organizational Funding

As noted above state and territorial governments have committed $33 million over five years to the national Safety and Quality Council to fund its action plan.

In addition, states and territories have their own quality councils. Funding models vary. For example, Victoria's Quality Council has an annual administrative budget of $3 million. New South Wales' Council on Quality in Health Care does not have its own administrative budget; it is funded by the Health Quality Branch.

Quality and Safety Branches

Some state health departments have quality and safety branches that are responsible for patient safety. New South Wales' Health Quality Branch has a budget of $1.5 million and eight staff devoted to patient safety initiatives.

Victoria's Quality and Care Continuity Branch has about 15 staff working on patient safety initiatives.

United Kingdom

UK funding for patient safety initiatives comes entirely from the Department of Health and its National Health Service. About £47 million (CDN$116 million) is spent annually on agencies working entirely or substantially on patient safety.

Organization Budget

Commission for Health Improvement

£11.3M

National Institute for Clinical Excellence

£13.1M

National Patient Safety Agency

£15M

National Clinical Assessment Authority

£7.7M

TOTAL

£47.1M

Because of the NHS' directing role over its trusts, it can and does mandate patient safety requirements that are accomplished from within existing resources. For example, clinical governance is a local responsibility mandated centrally by the NHS with resources provided to have a clinician responsible for it. Trusts are also directed to provide release time to physicians to allow them to prepare for their annual appraisals.

The NHS is also funding a Patient Safety Research Program. Its budget is £2.5M.

United States

Patient safety funding in the United States comes from a mix of government and private sources.

1. Federal Government

The Agency for Healthcare Quality and Research is the predominant federal agency involved in patient safety. It has an overall budget of US$251.7 million, of which $60 million is devoted to its Patient Safety Initiative. This funding includes money for research ($50 million), for challenge grants that will provide incentives to put patient safety systems-based interventions

2. Private Sector Incentives - Leapfrog Group

As noted above, Leapfrog Group members give hospitals with computer physician order entry systems, evidence-based hospital referral, and 24/7 availability of critical-care certified physicians in ICUs an advantage in the tendering process for employee health care benefits. Implementing these measures - especially computer physician order entry systems - requires significant investment. However, governments are not funding hospitals for these enhancements.

Nevertheless, some hospitals feel compelled to comply. Sutter Health, a large medical centre network in northern California with 25 hospitals and more than 100 clinical locations, has announced that it will spend US$50M on technology related to Leapfrog Group standards. This includes bar coding patient identification bracelets and linking them to computerized medication systems to ensure that the right patient gets the right medication. Sutter is receiving no funding from the federal or state government.

3. Private Sector Funding

The table below reports some of the larger private sector patient safety initiatives in the U.S. and their annual budgets.

Agency Budget U.S.$M

National Patient Safety Foundation

2.4

Leapfrog Group

0.8

Joint Commission on Accreditation of Healthcare Organizations*

51.0

Institute for Safe Medication Practices

3.0

National Quality Forum **

2.5

Total

59.7

* Half of $102m total budget ** Startup grant

Comparison and Analysis of Strategies

Summary of Strategies

Australian Strategy:

  • Commonwealth (federal) leadership, with the majority of the funding coming from the Commonwealth government, with significant state/territorial buy-in and additional funding
  • A national Safety and Quality Council that provides policy direction and attempts to build federal/state/territorial consensus and program co-operation
  • Lots of Safety and Quality Council policy papers and consultation
  • State/territorial and local health authority program implementation
  • Emphasis on incident reporting systems and root cause analysis
  • Almost all efforts currently focussed on hospitals
  • Reform of accreditation systems to be more effective on patient safety
  • Most Safety and Quality Council funding going to culture change

UK Strategy:

  • Department of Health and National Health Service leadership and direction
  • Use of numerous mechanisms including governance, regulation, accountability and reporting, funding and research
  • Provider and institutional-based accountability to national, centralized bodies
  • National patient safety organizations and frameworks set up by government to set clinical policy (NICE)(NSF), run incident reporting system (NPSA), assess physicians (NCAA), and assess and investigate institutions (CHI)(NCSC)
  • Local quality and safety requirements through clinical governance requirements
  • National, mandatory incident reporting and root cause analysis
  • No funds flowed to local institutions (trusts) for patient safety, but requirements imposed on them such as release time for physician assessment and clinical governance
  • Annual peer assessments of physicians
  • Comprehensive program scope that includes hospitals and primary care
  • Both public and private health care included

U.S. Strategy:

  • Federal government funding limited to research and program funding for Veterans Administration hospital programs
  • Little, if any, state funding of patient safety, with some states running sentinel incident reporting systems
  • Research is primary federal government focus, with majority of this funding going to develop incident reporting systems
  • No federal money going to hospitals to develop or operate patient safety programs; hospitals seem to be bearing the costs of patient safety themselves
  • Considerable focus on technology solutions such as computerized order entry systems, drug bar-coding etc.
  • Reliance on accreditation (JCAHO) that includes patient safety program review
  • Private sector funding being used as a driver - Leapfrog Group employers demanding patient safety measures in health programs they use for employees
  • Many private sector agencies contributing to patient safety efforts
  • Efforts largely limited to hospitals and drugs

Similarities in Strategies

As noted above all three countries share essentially the same policy assumptions about patient safety. This includes the understanding that adverse events in health care settings are common. Whether the rate is 3.7% or 22% does not affect the issue because even at the lowest rate the number of patients affected is dramatic. The lowest rate produces an extrapolated minimum 44,000 annual deaths in the U.S. The U.S. Institute of Medicine considers medical errors to be the largest avoidable cause of death.

All three strategies rely on reporting systems and root cause analysis: in Australia a mix of mandatory state/territorial government systems and voluntary organization systems for hospitals; in the UK a mandatory government system for hospitals and primary care; and in the U.S. a mix of voluntary national systems (JCAHO) and mandatory state systems for hospitals. Most reporting systems are in the developmental stage. In the UK pilot project NHS Trusts struggled with root cause analysis and positive feedback.

None of the countries are using professional governing bodies to deliver patient safety programs. Given the mandate of professional governing bodies to protect the public, their limited role may seem odd. In the case of the UK, it would appear that the General Medical Council has been found ineffective as evidenced by the outcome of the Bristol Inquiry. However, it may be unrealistic to assume that professional governing bodies can do much about patient safety given that their authority and history is largely limited to dealing after the fact in a disciplinary context with individual practitioners, and the fact that their mandates have not included dealing with institutions and multi-provider systems. They also have limited financial resources. (Some Canadian governing bodies have assumed a more proactive role with peer assessment programs and have expressed interest in patient safety initiatives. There may be more opportunity for governing body involvement here.)

The U.S. especially and the UK are funding research efforts. Australia's strategy appears to be to rely largely on others' results. Half of the U.S.'s annual US$50 million patient safety research budget goes to developing incident reporting systems. This is a reminder that the reporting systems are far from perfected.

All three countries face crises in medical liability coverage and recognize that they either need to reform their litigation systems or eliminate them entirely. There is also the recognition that incident reporting systems are not compatible with a litigious environment where disclosure may be legally detrimental. The U.S. Congress is attempting to reform indemnity laws, the UK is soon to publish a White Paper, and Australia has just formed a judicial commission.

Differences in Strategies

The roles national governments play is significantly different. In the UK the national government is clearly in charge, directing and funding all the initiatives. In Australia, the federal system limits the role of the national government, but this has not prevented the Commonwealth government from exercising national policy and funding leadership and achieving a consensus about the priority of safety and quality initiatives.

In the U.S. there is little federal leadership and less funding. The leadership roles envisaged for the AHRQ and QuIC have not materialized, in part because the Bush administration has placed more emphasis on the role of the Centers for Medicare and Medicaid Services. Most patient safety initiatives are operated and funded by private sector organizations and the hospitals themselves. The scale of involvement is somewhat proportional to the scale of public funding of the health care system. Not surprisingly, the national government's funding of health care is a predictor of the level of involvement in patient safety.

With the notable exception of research funding, only the UK has extended patient safety initiatives to primary care. Evidence suggests this is necessary. The Commonwealth Fund patient survey in the U.S. found that many medication errors occurred in physicians' offices; in the UK 11% of physicians referred to the National Clinical Assessment Authority were primary care physicians.

The U.S. strategy relies less on providers and culture change and more on research and technology. This focus may be influenced by the strong role played by the Agency for Healthcare Research and Quality which is primarily a research funding body. Perhaps this is also a consequence of the U.S. model being influenced by aviation safety where systems are designed to overcome human weaknesses.

The U.S. is the only country where private sector initiatives such as the Leapfrog Group have more direct health care delivery impact than government ones. The U.S. federal government does not seem to be using Medicare and Medicaid funding to require patient safety improvements.

The UK has the most uniform application of patient safety initiatives. Australia is next, but the federal system with differing sizes of states and territories precludes uniform application, although the Australian Health Care Agreements per capita funding mitigates this to some extent. The U.S. lacks any national government-mandated standards, but the JCAHO's accreditation might be considered a de facto national standard.

Funding Analysis

In Australia and the UK, the national governments - as the major funders of hospitals and other health care services - are investing in patient safety initiatives. In the U.S. governments fund 45% of health care, but they are not investing an amount comparable to the UK or Australia if the number and cost of preventable incidents and deaths are benchmarks.

Incident Costs and Government Patient Safety Investments
  Cost Estimate of Preventable Incidents Estimated Annual Deaths - Range Patient Safety Investment $ Canadian
Australia AUS$867m 10-14,000 AUS$141m $120m
United Kingdom £2,000m 25,000 £47m $117m
United States US$17,000m 44-100,000 US$60m $95m

It needs to be emphasized that these figures do not reflect the total amounts being spent on patient safety in each country. In the United States in particular, most of the costs of patient safety initiative seem to be being borne by hospitals that are initiating programs to meet JCAHO standards or buying computer systems to meet Leapfrog Group requirements.

The scale of investment being made by governments varies significantly, as the table below illustrates.

Government's Per Capita Patient Safety Investments
  Annual Investment Population Per Capita $ Canadian per capita

Australia

AUS$141

19m

$7.42

$6.38

United Kingdom

£47m

59m

£0.86

$2.13

United States

US$60m

273m

$0.22

$0.35

U.S. with private

US$119.7

273m

$0.44

$0.70

The Australian figure is likely somewhat inflated because it includes the Australian Health Care Agreements' quality funding. However, even if half of this funding is not at all related to patient safety it still means that Australia is investing the most per capita. Australia is the only one of the three countries to flow government patient safety funding to front line delivery organizations - the states/territories flow AHCA funds to local health authorities.

As patient safety initiatives mature and effective measures become available, the next steps will require capital and operating investment in hospitals, physicians' offices and other health care settings. The U.S. strategy may be the most expensive to implement because it is largely technology-based. It seems likely that all governments' investment will have to substantially increase if technology solutions such as computer ordering systems, drug bar code systems, and computerized incident reporting are to be implemented.

Evaluations of Strategies

Most patient safety initiatives are in their infancy, having been started in 2001 or 2002, or being currently piloted. There has been no evaluation of any of the three countries' overall efforts. None of the governments seem to have undertaken any evaluation, or if they have, made it public.

It may be necessary to have a fully developed incident reporting system in place for several years before results can be evaluated.

Two evaluations of the effectiveness of clinical patient safety measures in the U.S. are described in the appendix.

Endnotes

[i] A Framework for Managing the Quality of Health Services in New South Wales. NSW Health, p. 2

[ii] Brennan et al, Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study 1. New England Journal of Medicine, 324:370, 1991

[iii] Commonwealth Department of Health and Family Services, Task Force on Quality in Australian Health Care: Final Report

[iv] Ibid, p.5

[v] 1m patients suffer harm in NHS hospitals. Guardian, June 19, 2002

[vi] Richard B. Clark, Australian Patient Safety Survey. Commonwealth Department of Health and Aged Care, August 2001

[vii] Karen Davis et al., Room for Improvement: Patients Report on the Quality of their Health Care. The Commonwealth Fund, April 2002, pp.3-4

[viii] U.S. Department of Health and Human Services, Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Costs by Fixing Our Medical Liability System. Washington. July 24. 2002, p. 9

[ix] National Audit Office, Handling clinical negligence claims in England, May 2001, p. 1

[x] Quoted in 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

[xi] Commonwealth of Australia, Australian Health Care Agreement with State of New South Wales, paragraph 29, p.9

[xii] Safety and Quality Council, Action Plan 2001, p. 4

[xiii] Building a safer NHS for patients, p. 45

[xiv] www.jcaho.org News release July 24, 2002

[xv] National Audit Office, Handling clinical negligence claims in England, May 2001

[xvi] Enduring Solutions, A Patient Safety Plan for the ACT. February 1999, p. v

[xvii] Institute of Medicine, To Err is Human, p. 4

[xviii] Ibid, p. 21

[xix] Enduring Solutions, A Patient Safety Plan for the ACT. February 1999, p. v

[xx] National Health Service, A Commitment to Quality, a Quest for Excellence. June 2001, p. 7

[xxi] Ibid, p. 17

[xxii] Ibid, p. i

[xxiii] Ibid, p.46

[xxiv] 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

[xxv] Communique: Ministerial Meeting on Medical Indemnity, April 23, 2002

[xxvi] Op. cit., p. 451

[xxvii] Op. cit., p. 162

[xxviii] U.S. Department of Health and Human Services,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

[xxix] Ibid, p. 6

[xxx] Ibid, p.7

[xxxi] Department of Health, Shifting the Balance of Power, The Next Steps, p. 44

[xxxii] www.doh.gov.uk/clinicalgovernance

[xxxiii] Nigel Starey, What is clinical governance? Hayward Medical Communications, p.2

[xxxiv] NSW Health Complaints Commission, The Complaints Process, p. 8.

[xxxv] Response to Bristol, p. 141

[xxxvi] Ibid, p. 12

[xxxvii] Ibid, p. 5

[xxxviii] Commonwealth Department of Health and Aged Care, Australia: Selected Health Care Delivery and Financing Statistics - September 2000, p. 4.

[xxxix] Australian Capital Territory Government, Quality First: a commitment to quality and safety and act health services. p. 5

Appendix

The Appendix to: Governments and Patient Safety in Australia, the United Kingdom and the United States - August 2002 is available upon request. To obtain an electronic copy, please contact Health Canada General Inquiries.


  1. Sentinel events are defined as "relatively infrequent, clear-cut events that will occur independently of a patient's condition; commonly reflect hospital system and process deficiency; and result in unnecessary outcomes for patients." Often they are enumerated by the reporting agency. See appendix.
  2. 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.
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