In this chapter, the QuIC responds to recommendations from the IOM report and describes how the Federal Government can act on the issues of medical error and patient safety. This includes responses by the QuIC, as an interagency coordinating organization, as well as responses by individual agencies of the QuIC.

National Focus and Leadership

Center for Patient Safety

IOM Recommendation

Congress should create a Center for Patient Safety within the Agency for Health Care Policy and Research. This Center should:

• Set the national goals for patient safety, track progress in meeting these goals, and issue an annual report to the President and Congress on patient safety.
• Develop knowledge and understanding of errors in health care by developing a research agenda, funding Centers of Excellence, evaluating methods for identifying and preventing errors, and funding dissemination and communication activities to improve patient safety (IOM; 1999, page 6).

QuIC Response

The IOM’s recommendations build upon AHRQ’s focus on health care quality, its expertise, and its track record in funding research, training, and dissemination activities. AHRQ will take immediate action to expand the mission of the Center for Quality Measurement and Improvement, creating the Center for Quality Improvement and Patient Safety (CQuIPS), which will provide leadership in reducing medical error and improving patient safety. Integration of the patient safety agenda within AHRQ’s existing quality improvement efforts reflects an approach similar to that used by the IOM, in which its work on patient safety was included within a broader "Quality in America" framework.

The formation of CQuIPS explicitly recognizes that patient safety and quality improvement are complementary activities with great potential for synergy. Furthermore, establishing the Center takes advantage of AHRQ’s current infrastructure, which includes a center focusing on quality improvement and a task force that advises the Director on matters related to patient safety and medical errors. The Center will develop initiatives in these areas and facilitate communication between the Agency and external organizations. In the Center’s first year, the President has proposed a budget of an additional $20 million to be spent on research.

The Center will:

1. Conduct and provide grants and contracts for extramural research on patient safety and the causes of medical errors, and on the effectiveness of programs to reduce them.
2. Include patient safety within the broader focus of quality measurement and improvement.
3. Bring together individuals and groups from the public and private sectors with an interest in patient safety.

Because the Center’s role will not include regulatory, payer, or provider functions, it is well positioned to share information from both the private and public sectors (e.g., pooling and analyzing results of State mandatory error reporting systems). Additionally, patient safety will be integrated into the activities of other organizational units within AHRQ.

The Center’s functions will be coordinated with and complementary to other private-sector and Federal initiatives focused on error reduction and improved patient safety. For example, VA, CDC, HCFA, FDA, DoD, the National Patient Safety Foundation (NPSF), the National Patient Safety Partnership (NPSP), and professional societies all have expertise relevant to identifying and reducing medical errors and improving patient safety. Their collaboration via the QuIC will enhance the Center’s functions. One example of such collaboration will be the Center's development of a curriculum for QuIC participants on reducing medical errors that can be used as a model and expanded by other public- and private-sector organizations.

• AHRQ will take immediate action to establish the Center for Quality Improvement and Patient Safety (CQuIPS), which will replace and broaden the mission of AHRQ’s Center for Quality Measurement and Improvement.
• CQuIPS will coordinate with and complement other public- and private-sector initiatives to improve patient safety.
• QuIC will coordinate Federal activities on patient safety, as it does on the broader quality agenda. This will include both regular meetings of the QuIC and use of its current structure to redirect QuIC working group efforts towards enhancing patient safety.
• AHRQ will sponsor a program to educate personnel of QuIC member agencies about patient safety, bringing them together with leading researchers on human factors analysis, systems design, error reporting, and quality improvement. This curriculum will serve as a model and be expanded for future educational activities with private-sector partners.
• QuIC agencies such as OPM, HCFA, DoD, and VA will demonstrate their national leadership as purchasers and providers of care, developing model programs that use information on errors to improve patient safety.
• Federal agencies and other bodies, including AHRQ, FDA, CDC, and HCFA, will collaborate to provide national leadership in developing and testing systems of mandatory reporting for public accountability.

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Research Planning

IOM Recommendation

Develop a research agenda, conduct and fund intramural and extramural research to assess the magnitude of errors and the role of human factors, and test and evaluate approaches for preventing errors.

QuIC Response

A substantial research program is central to the overall effort to improve patient safety and reduce medical errors. Without the evidence base that research provides, efforts to reduce errors and improve safety are unlikely to be fully productive, and may even be harmful. An example of an event with potential for harm is the automation of health care processes without due consideration of system design and human–technology interfaces. Automating a flawed system may invite errors and further mask their occurrence.

Research also is needed on the role of patients in helping to reduce errors. While much is known about the power of patient participation in helping to improve overall patient outcomes and satisfaction, research is sparse regarding the patient’s role in error reduction (e.g., wrong-site surgery, medication errors). In general, further research is needed on how best to measure medical errors, explore options for reporting them, understand why they occur, and test the success and cost-effectiveness of various approaches to improving safety, including the patient’s role in helping to prevent errors.

A number of research activities are currently underway in Federal agencies and departments. In December 1999, AHRQ released a request for grant applications to research the effectiveness of the transfer and application of "best practices" to reduce medical errors that are frequent, serious, and preventable. AHRQ also is supporting a project conducted by the NPSF that identifies and gathers information on public- and private-sector agencies and organizations funding research on medical errors and patient safety. This is effort helps to coordinate research initiatives, prevent overlaps, and identify research gaps.

Other agencies and departments also have research projects underway. VA is evaluating grant applications focused on mitigating adverse drug events and has established four Patient Safety Centers of Inquiry to develop innovative solutions to critical challenges in patient safety. HCFA is funding the Study of Clinically Relevant Indicators for Pharmacologic Therapy (SCRIPT) to develop and test a core set of measures that can be used to evaluate and improve medication use associated with significant morbidity, mortality, and unnecessary cost. The FDA is strengthening its understanding of the impact of pre- and postmarket risk management decisions, which includes exploring the association between errors and medical products, human factors and pharmaceutical name confusion, patient communication, exposure to risk, and improved methods for extracting information from both large reporting databases and patient medical records.

Federal agency collaborative efforts also are underway. For example, in 1999 AHRQ funded four Centers for Education and Research on Therapeutics (CERTs). Established as part of the FDA Modernization Act of 1997 and administered by AHRQ in collaboration with the FDA, the CERTs examine the benefits and risks of new drugs, biologics, and medical devices. Under the aegis of the QuIC, several agencies and departments will implement a project in 2000 focused on identifying and reducing medical errors in high-hazard health care environments.

While important and timely, however, these initiatives fall short of meeting the ambitious research agenda described in the IOM report.

The QuIC proposes a broad research initiative aimed at developing evidence-based approaches to reducing medical error and improving patient safety, but it will require substantial additional funding. With coordination, direction, and input through AHRQ’s new CQuIPS, this initiative will include setting a coordinated research agenda, supporting research and demonstrations, evaluating programs, developing tools and training initiatives, and disseminating findings. Potential components of this initiative are outlined below.

• Hold national summits on medical error and patient safety research: AHRQ will lead the convening of conferences and expert meetings to review the information needs of those who wish to improve safety, assess the current state of patient safety research, set coordinated research agendas, and develop adequate reporting mechanisms. VA will lead a summit on lessons learned from its experiences in improving patient safety, and the FDA will lead a summit on drug errors. These summits will take place within 1 year.
• Establish joint research solicitations (including partnerships between AHRQ, CDC, FDA, and VA) for:
—Fundamental Research on Errors: Investigate root causes analysis, informatics, the role(s) of human factors, and legal/judicial issues.
—Research on Reporting Systems: Identify critical components of successful reporting systems used for learning, examine options for voluntary and mandatory reporting systems, implement and evaluate demonstration programs for reporting, evaluate existing State mandatory reporting systems, and investigate techniques and methods for analyzing and disseminating patient safety data (including integration into a National Quality Report being prepared by DHHS under the leadership of AHRQ and CDC).
—Applied Research on Patient Safety: Test the application of human factors knowledge to the design of health care products, processes, and systems; identify best practices in reducing errors; fund patient safety "Centers of Research Excellence"; and support research and demonstrations on-site, as well as level-of-care and cross-cutting research, such as in diagnostic accuracy, informatics applications, and systems re-engineering.

• Develop tools for the public and private sector to support efforts to enhance patient safety, including:
—Applications: Identify tools and approaches from other industries that could be applied to the health care sector and develop community-based settings that can serve as laboratories for error reduction through medical specialty societies, primary care networks, and integrated service delivery networks.
—Measures: Develop and evaluate data specifications for reporting on patient safety and work with the Quality Forum and other private- and public-sector efforts on developing consensus around a core set of measures for patient safety.
• Finalize a QuIC Research Agenda on Working Conditions and Patient Safety. The QuIC will finalize a research agenda to explore the relationship between health care workers’ working conditions and the quality of patient care, including patient safety. CDC and AHRQ will coordinate this activity with VA and other agencies.

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Identifying and Learning From Errors

IOM Recommendations

A nationwide mandatory reporting system should be established that provides for the collection of standardized information by State governments about adverse events that result in death or serious harm. Reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care delivery settings. Congress should:

—Designate the Forum for Health Care Quality Measurement and Reporting as the entity responsible for promulgating and maintaining a core set of reporting standards to be used by States. Reporting standards should include a nomenclature and taxonomy.
—Require all health care organizations to report standardized information on a defined list of adverse events.
—Provide funds and technical expertise for State governments to establish or adapt their current error reporting systems to collect the standardized information, analyze it, and conduct followup action as needed with health care organizations. Should a State choose not to implement the mandatory reporting system, the Department of Health and Human Services should act as the body responsible for data collection and analysis. Further, the Center for Patient Safety should be designated to:

1. Convene States to share information and expertise, and evaluate alternative approaches taken for implementing reporting programs, identify best practices for implementation, and assess the impact of State programs.
2. Receive and analyze aggregate reports from States to identify persistent safety issues that require more intensive analysis and/or a broader based response (e.g., designing prototype systems or requesting a response by agencies, manufacturers or others).

The development of voluntary reporting efforts should be encouraged. The Center for Patient Safety should:

• Describe and disseminate information on external voluntary reporting programs to encourage greater participation in them and track the development of new reporting systems as they form.
• Convene sponsors and users of external reporting systems to evaluate what works and what does not work in the programs and ways to make them more effective.
• Periodically assess whether additional efforts are needed to address gaps in information to improve patient safety and to encourage health care organizations to participate in voluntary reporting programs and
• Fund and evaluate pilot projects for reporting systems, both within individual health care organizations and within collaborative efforts among health care organizations.

QuIC Response

The IOM report states that to decrease the incidence of errors in the health care system, it is necessary to have and use information. The IOM’s recommendations reflect two important information needs that are vital to efforts to improve safety. First, the public expects and has a right to information that will demonstrate that the health care delivery system is as safe as possible. Second, there is the need for data and information in support of efforts to learn why errors occur and what changes are effective in preventing errors or minimizing their effects. Both needs can be met only through the development of effective data collection systems. Additionally, accountability and learning will only be achieved if the data are analyzed and information is fed back to the users.

The kind of information that is produced from these systems needs to be useful to those who can act on it. Learning systems must be designed to produce information for providers, drug and device manufacturers and others. Accountability systems must meet the information needs of the public, public policymakers, and purchasers. The data needs for accountability and those for learning are complementary but not identical.

The QuIC believes that the IOM is correct in identifying these information needs, and will take steps—in collaboration with a variety of other organizations—to begin to meet them. As appropriate, the QuIC supports the extension of peer review protections to encourage reporting. Details of these extensions are given in "Peer Review Protections," below.

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Accountability

The Federal agencies are committed to providing the public with information about the safety of the health care delivery system, in general, and about the providers from which they can choose. To that end, the QuIC proposes that the Quality Forum identify those patient safety practices that health care organizations have adopted and that have been proven through research to be effective in reducing errors. The QuIC anticipates that the Quality Forum will encourage health care organizations to adopt these practices and inform the public of their use.

As a start, OPM will require that the provider organizations with which it does business have patient safety programs in place and provide public information on what those programs do. This information will be disseminated broadly on OPM’s Web site and through other mechanisms available to it. Methods for insuring this reporting are further described in "Raising the Standards for Health Care Organizations" and "Raising the Standards for Health Care Professionals."

While information on what programs are in place will be useful, it may not be sufficient to ensure the public is able to make the decisions it wants to make about its health care. Therefore, the QuIC proposes to look at how to provide useful information on errors to the public. This examination will consist of two separate parts.

First, AHRQ will lead a QuIC effort to examine the existing State reporting systems that have been designed for public accountability, to learn what their common characteristics are, how effective they have been in providing information to the public, and what have been the most successful elements of those programs. This information will be shared with the States that currently operate error reporting systems and others that are considering developing such systems, as a means of encouraging improvement and expansion of State reporting. The goal would be for all States to have a reporting system for errors within 3 years. If, at the end of 3 years, all States have not implemented reporting systems, the QuIC will recommend options to the President so that all health care institutions are reporting serious errors.

Second, HCFA will experiment with creating its own program for collecting and reporting publicly on medical errors that result in significant harm to patients and are preventable, given the current state of knowledge. Examples of such events are: surgery on the wrong body part, surgery on the wrong patient, and suicide while the patient is being watched to prevent a suicide. HCFA proposes to conduct a pilot study of such a mandatory reporting system for these events in collaboration with a State. It will work with the Quality Forum or similar entity to develop a finite list of events to be reported, and will ensure they have unambiguous definitions. In addition, HCFA will ask the Quality Forum or other entity to advise it on how best to report the information to the public to ensure it is understandable and useful.

HCFA will work with the chosen State to require that such events are reported by all hospitals in the State and published on a hospital-by-hospital basis. The published data will be stripped of all information that might jeopardize patient confidentiality. In the course of the pilot study, HCFA will refine any definitions and work out the operational issues of enforcement and reporting mechanics with the State Survey and Certification agency. HCFA and its QuIC partners will evaluate whether consumers found this information valuable and what they understood about it, and how they used it. Finally, HCFA and its QuIC partners will evaluate the impact of such a system on confidential reporting for learning from errors.

If successful, based on the results and evaluation of the pilot study by HCFA and its QuIC partners, HCFA will move towards a national mandatory reporting system for all hospitals participating in the Medicare program, with the intent of making the data publicly available.

Serious errors and accidents also occur during the collection, testing, and administration of human blood. On January 27, 2000, the DHHS Advisory Committee on Blood Safety and Availability recommended, among other things, facilitating development of technology to prevent misidentification of blood products and/or recipients. By the end of the year, FDA will release regulations to improve the safety of blood transfusions by requiring the over 3,000 blood banks and establishments dealing with blood products to report errors and accidents, such as mistyping blood products and adverse events affecting donors, that affect patient safety. Currently, only 400 blood banks are required to report such errors.

In addition to broad public accountability, the IOM asserted that providers have the responsibility to provide information to affected individuals and their families about mistakes that cause serious injury or death. The QuIC agrees with this recommendation. However, subsequent investigations by the health care organization into the causes of error need not be shared.

• The QuIC will ask the Quality Forum to define unambiguously, within 12 months, a set of egregious errors that are preventable and should never occur. These measures will serve as criteria for a HCFA-sponsored mandatory reporting demonstration project with a State that already has an existing mandatory reporting requirement. HCFA will publish the hospital rates for these events without patient identifiers.
• HCFA and its QuIC partners will evaluate whether consumers found this information valuable and what they understood about it. Based on these results, HCFA will move towards a national mandatory reporting system, with publication of findings, for all hospitals participating in Medicare.
• Federal agencies, in partnership with other organizations, will develop options for mandatory reporting systems that provide the public and purchasers with publicly available information about programs and procedures in place to reduce errors. This work will require the development of evidence-based, systems-level measures in collaboration with the Quality Forum.
• OPM will require that health plans have error reduction plans, and will report on its Web site whether the health plans have reliable patient safety initiatives in place.
• QuIC will ask the Quality Forum to identify, within 12 months, patient safety practices that institutions should undertake and urges that information about whether the measures are in place be made available to the public.
• FDA will report to the public on the safety of drugs, devices, and biologic products.
• QuIC proposes that State and Federal mandatory reporting systems, as well as those of private accrediting and other oversight groups, be evaluated to determine the ways in which they are helpful in assuring public accountability for patient safety, and that these results be used to develop future reporting systems.
• AHRQ will include information on patient safety in the National Quality Report it is developing in collaboration with other agencies, in particular, the National Center for Health Statistics.
• OPM will require that health plans describe their patient safety initiatives, will make patient safety information available in both print and electronic formats for the open enrollment period in Fall, 2000, and will expand its web site to include information about programs designed to reduce errors and enhance patient safety.
• OPM will encourage health plans to annotate Preferred Provider Organization (PPO) directories to indicate which hospitals and physicians’ offices use automated information systems.
• FDA will improve the safety of transfusions by expanding mandatory reporting requirements for blood bank errors and accidents, so that they apply to all registered blood establishments.

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Learning from Errors

To learn from errors, the aviation industry experimented with different models, but found it most useful to have a large national database of information that can be analyzed for patterns of underlying causes of mistakes. This ensures that data from events that rarely occur, but which have dire consequences, can be more readily identified. At the moment, no comprehensive system of data collection exists that will drive the Nation’s efforts to learn from medical errors.

To inform its thinking about how such a system should be constructed, the QuIC reviewed data collection systems that have been designed to support learning systems in other industries. Successful reporting programs possess the following common characteristics.

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Characteristics of an Ideal Reporting System for Learning

• The intent and goal of the reporting system are clear to all interested parties.
• Active leadership support is ensured at all levels.
• Reports are accepted from all interested parties.
• Reports are confidential and identifying information has been removed.
• Reports are used for prevention, not punishment.
• Reports are analyzed by technically expert peers, from multiple perspectives.
• Reporting is easy to do and captures rich detail.
• Reporters and larger interested communities receive timely feedback.
• Pilot testing and prototyping of the system takes place before large scale roll-out occurs.

Currently, several databases exist that collect information on specific types or errors, such as CDC’s hospital acquired infections reporting systems, FDA’s adverse drug and device event reporting systems, and the JCAHO’s sentinel event system. Others exist that collect information on errors that occur in a particular health care system, such as VA’s error reporting system. As previously mentioned, some States have data collection systems for the facilities within their boundaries.

The QuIC believes that the fastest way to create a useful and analyzable data set would be to integrate the data from these existing databases and from any others that exist. AHRQ has experience in creating such harmony from disparate data collections. Within its Healthcare Cost and Utilization Project (HCUP), AHRQ currently employs cooperative agreements with 22 States to ensure the collection of a core set of administrative data from hospital discharges that are then aggregated. These data are then made available for research and analysis, in a way that protects patient and provider identities. The QuIC proposes that a similar method should be used to create an errors database that can be used to provide important insights into the causes and effective methods for prevention of errors. AHRQ will lead an effort to gather information from those who run the existing error data-collection systems, including the Federal, State and private-sector systems. This evaluation of existing systems will be used to determine whether they can be aggregated into a single database.

The aviation reporting system, which the IOM and others have suggested as a model that health care should emulate, depends on the collection of as much information as possible about close calls (which are sometimes called near misses) as well as errors that actually resulted in harm. To encourage people to report errors and speed the availability of information, the aviation system protects the identity of those who report and those who are involved in the incident. The QuIC will encourage States and others to include sufficient protections on the information to ensure that providers will report errors. This issue is discussed more fully in the section on Peer Review Protections.

A common set of core measures is necessary to integrate a broad array of data collected through different reporting systems. The Quality Forum can ably undertake the creation of a common set of core measures for a national errors database. The QuIC agencies would support such an effort by the Quality Forum or other appropriate private-sector body.

Patients can reveal information about their care experiences, including errors that occurred during their care, that are not otherwise available. Systems will also be created that will enable patients to report errors and adverse events, using a standard reporting format that will complement the error reporting and collection activities of health care professionals and facilities. To collect such data, the QuIC will design a Web-based error reporting mechanism.

Within six months, HCFA, working with a Peer Review Organization (PRO) program, will develop a pilot study of a confidential, penalty-free learning system with several hospitals on a voluntary basis.

First, the PRO will assemble routine hospital error reports to create a highly confidential database of documented errors occurring in the participating hospitals. This database would include both near misses and actual patient harm. The PRO will use the standard taxonomy of medical errors adopted by the Quality Forum, and use the collected data for education and technical assistance, not for punitive actions. This is consistent with the educational strategy that PROs have adopted over the past decade.

Second, the PRO will provide support for provider and practitioner error reduction programs through participating in local root cause analysis of near misses as well as the episodic serious adverse events, to identify patterns of medical errors. The PRO will feed back and interpret information from the database, convene workgroups of interested and expert parties, and facilitate the exchange of best practices that could be shared between participating hospitals. The PRO will also provide the data, with all identifiers removed, to AHRQ, HCFA, and other partners and investigators. With this information, the PRO will work with hospitals and practitioners on systems interventions to reduce medical errors.

Beginning this spring, the Department of Defense will implement a new reporting system in its 500 hospitals and clinics, which serve approximately 8 million patients. This reporting system will be modeled on the system in operation at the Department of Veterans Affairs and will be used to provide health care professionals and facilities with the information necessary to protect patient safety. This system will begin to be pilot tested in August of 2000, will collect information on adverse events, medication errors, close calls, and other patient safety issues. Under this system, patients or their families are notified when a serious medical mistake has been made.

The VA currently operates a mandatory reporting system. By the end of the year, the VA will implement a voluntary reporting system for both adverse events and close calls nationwide. Information will be collected by an independent external entity, analyzed, and disseminated to all VA health care networks to help prevent medical errors before they occur. Implementing this system is likely to lead to a richer database of information, as incidents are reported on a de-identified basis, and will allow researchers to compare the effectiveness of identified systems to de-identified ones.

While the aggregate database is being created, Federal agencies, such as the VA, CDC, and FDA will continue to examine their own data for critical information on why errors occur and how to avoid them. This information will continue to be communicated to appropriate health care organizations, manufacturers, and others who need to act on it. Once the database has been created, AHRQ will lead Federal efforts to expand both the knowledge of errors and communication with providers and others who can act on this information. Both information about methods shown to be effective in reducing errors and particular hazards will be communicated to providers.

The information about what methods have been shown to be effective in reducing errors will also be shared with organizations that have health care oversight or purchasing responsibilities, so that they can choose to incorporate them into their efforts to ensure accountability as appropriate. This forms a natural link between the learning systems and the accountability systems for error reduction. Health care provider organizations can be held responsible for adopting methods shown to be effective in reducing errors, and the public should be given information that demonstrates such initiatives are in place and are effective.

• The new Center for Quality Improvement and Patient Safety (CQuIPS) at AHRQ will identify existing State and Federal reporting systems (both mandatory and voluntary), evaluate their suitability in helping to build a national system of errors reporting, and evaluate how their data collection or enforcement efforts can be enhanced to improve the value of those systems.
• QuIC will work with the Quality Forum to develop reporting criteria that assure that information can be pooled and shared as needed across organizations.
• CQuIPS, working with the QuIC, will describe and disseminate information on characteristics of existing voluntary reporting programs associated with successful error reduction and patient safety improvement efforts. FDA, CDC, and NASA will provide expertise in the development of these nonpunitive systems.
• Within six months, HCFA, working with a Peer Review Organization (PRO) program, will develop a pilot of a confidential, penalty-free learning system with several hospitals on a voluntary basis.
• Federal agencies, including the FDA, VA, DoD, CDC, HCFA, and AHRQ, will integrate data from different sources and conduct and support analysis to identify error prone procedures, products, and systems.
• By August 2000, the DoD will complete development of a patient safety improvement program based on a reporting system modeled on that of the VA.
• VA will establish a voluntary reporting system to supplement its existing mandatory system.
• AHRQ, in collaboration with other Federal agencies, will investigate, develop and test strategies to provide effective feedback to clinicians and institutions on methods for improving patient safety.
• Federal agencies will assist health care providers to develop the skills necessary for analyzing adverse events and near misses (e.g., root cause analysis, trending, search tools). Federal agencies providing health care will develop internal systems to 1) identify and report errors to clinicians and other decision makers, and 2) learn from those errors and near misses to prevent future events.
• Outreach to Stakeholders: QuIC will develop programs to foster the dissemination of research findings to end users through activities such as AHRQ’s User Liaison Program; provide support to the Quality Forum to increase the national discussion on errors, their reduction, and standardized measures of errors; and fund collaborative agreements with health care professional organizations that foster education, track patient safety initiatives, provide input to the new patient safety research centers, and translate, disseminate, and promote adoption of research findings.
• Patient Safety Clearinghouse: AHRQ will develop a clearinghouse in partnership with other Federal agencies and private-sector organizations to provide an objective source of state-of-the art information on patient safety.
• AHRQ will initiate a "National Morbidity & Mortality Conference" posting selected cases (stripped of identifying information) in a public forum via Internet technology, and establish a Web site where patients can report incidents that will be analyzed to identify emerging problems.

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Analysis and Feedback

On pages 85 and 86, the IOM report summarizes two important points: 1) caution must be exercised when calculating rates from any type of adverse event reporting system; and 2) the goal of reporting systems is not to count the number of reports.

Successful error reporting systems are analysis and feedback systems. The key to their success starts with a highly visible ability to properly analyze cases and recommend changes to those who are empowered to implement them. Experts in the field of patient safety report that understanding the "root" of the problem and the "contributing" factors are winning strategies; counting errors and comparing performance are not.

Feedback to key decision makers and those who report is the second part of all successful error reporting systems. The CDC and FDA have found that lack of feedback was one of two main reasons for failed "mandatory" systems. Other activities contributing to success include: 1) training for those with reporting responsibilities; and 2) free software and generic data to aid internal analysis.

Experience with other reporting systems for improving safety demonstrates the importance of closing the feedback loop. Timely and usable feedback is crucial in making the system useful to those who report. Therefore, reporting formats should include both free-text narrative and standardized information as well as indicate how those who report can use the feedback.

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