Chapter 3. AHRQ's Patient Safety Initiative: Breadth and Depth for Sustainable Improvements
AHRQ's Patient Safety Initiative: Building Foundations, Reducing Risk
In Senate Report No. 107-84, the Senate Committee on Appropriations requested that AHRQ describe how it was responding to applicable recommendations in IOM's report, To Err Is Human: Building a Safer Health System.1 This chapter addresses AHRQ efforts to develop a well-guided and effective Patient Safety Initiative, the status of those efforts, and our plans in for the near- and long-term. This section specifically addresses IOM Recommendations 4.1 and 8.1, the only recommendations relevant to the questions asked by Congress addressed in this report.
Congressional and IOM Guidance Lead To Major Role for AHRQ in Patient Safety
In its November 1999 landmark report on patient safety, To Err is Human, the IOM's Committee on Quality of Health Care in America made a number of specific recommendations regarding the role that AHRQ should play in patient safety. Recommendation 4.1 states:
Congress should create a Center for Patient Safety within the Agency for Healthcare Research and Quality. 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; and
- 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.1
AHRQ's reauthorizing legislation, signed into law on December 6, 1999, gave the Agency the mission of establishing a comprehensive Patient Safety Initiative. The reauthorization specified that the Director of AHRQ "shall conduct and support research and build private-public partnerships to:
- Identify the causes of preventable health care errors and patient injury in health care delivery.
- Develop, demonstrate, and evaluate strategies for reducing errors and improving patient safety.
- Disseminate such effective strategies throughout the health care industry."16
In FY 2001, AHRQ re-named its Center for Quality Measurement and Improvement as the Center for Quality Improvement and Patient Safety (CQuIPS). This was the initial step in a series of efforts to re-focus and concentrate in one organizational unit activities designed to improve the safety of the health care Americans receive.
CQuIPS leads patient safety planning, execution, and evaluation within AHRQ and has primary responsibility for:
- Evaluating methods for identifying and preventing medical errors.
- Developing and testing measures and methods for evaluating the quality of care and enhancing patient safety.
- Providing technical assistance and gathering information on the use of quality measures, consumer and patient information, and reporting on patient safety and the resulting effects.
- Developing and disseminating an annual report on health care quality in general, including patient safety specifically.
- Representing the Agency in meetings with domestic and international experts and organizations concerned with measuring and evaluating the quality of care and enhancing patient safety.
AHRQ's Long-Range Plan to Address Patient Safety
To shape the Patient Safety Initiative and develop an extensive research agenda, AHRQ sought input from a broad array of stakeholders and users, including AHRQ's National Advisory Council and the Federal Quality Interagency Coordination Task Force (QuIC). The QuIC includes other DHHS agencies as well as other Federal agencies involved in various aspects of the delivery, purchase, regulation, or study of health care services.
National Advisory Council
AHRQ's National Advisory Council is comprised of private-sector experts who contribute a varied perspective on the health care system. They advise AHRQ regarding research to promote improvements in the quality, safety, outcomes, and cost-effectiveness of clinical practice, and they advise AHRQ on strategies to promote improvements in the health care system. The private-sector members represent health plans, providers, purchasers, consumers, and researchers. Also serving in an ex-officio capacity are principal representatives of Federal agencies that address health care system issues:
- The Assistant Secretary for Health.
- Components of the Department of Health and Human Services, including the CDC, FDA, CMS, and NIH.
- The Department of Veterans Affairs.
- The Office of Personnel Management.
- The Department of Defense (Health Affairs).17
Quality Interagency Coordination Task Force
The purpose of the QuIC, which was established in 1998, is to ensure that all Federal agencies involved in purchasing, providing, studying, or regulating health care services are working in a coordinated manner toward the common goal of improving the quality of care. The QuIC is comprised of representatives of:
- The Departments of Health and Human Services, Labor, Defense, Veterans Affairs (VA), and Commerce.
- The Office of Management and Budget.
- The Office of Personnel Management.
- The U.S. Coast Guard.
- The Federal Bureau of Prisons.
- The National Highway Transportation and Safety Administration.
- The Federal Trade Commission.
In February 2000, QuIC issued a report, Doing What Counts for Patient Safety: Federal Action to Reduce Medical Errors and Their Impact.18 The QuIC report laid out a road map of more than 100 needed activities to:
- Create a national focus on reducing errors.
- Develop a knowledge base for learning about errors' causes and effective error prevention.
- Ensure accountability for safe health care delivery.
- Guarantee that patient safety practices are implemented.
Examples of the types of activities that were recommended included:
- Action to establish CQuIPS.
- Holding national summits on medical errors and patient safety research to help focus efforts on improving the safety of care.
- Initiating a Web-based morbidity and mortality-like program to expand the opportunity for learning from a single hospital to a national level.
- Integrating data from different sources to identify error-prone procedures.
- Initiating a Department of Veterans Affairs non-punitive medical error reporting system.
- Working with several hospitals on a voluntary basis to implement a CMS quality improvement organizations pilot project for confidential, penalty-free learning.
- Incorporating patient safety information into the National Healthcare Quality Report.
- Participating in an Institute for Healthcare Improvement collaborative focused on patient safety on behalf of QuIC members.
- Developing and piloting a VA patient safety education program for medical residents and students.
A majority of activities recommended in the QuIC's report have been initiated, are underway, or are completed. The QuIC continues to provide both guidance as well as a forum in which various Federal agencies can work together to address issues of patient safety. AHRQ works closely with its QuIC partners in designing, developing, and carrying out various patient safety and quality improvement activities.
In addition, AHRQ and its QuIC partners provide several public forums during which interested parties provide feedback on patient safety research and on setting a research agenda to reduce medical errors and improve patient safety. One such forum early in the initiative was the National Summit on Medical Errors and Patient Safety, which was attended by public and private-sector users and funders of health care research. Held in September 2000 in Washington, DC, the National Summit was a 1-day meeting designed to solicit responses from the users of patient safety research about their pressing needs, and to highlight specific research questions related to those needs. The following research areas were outlined:
- Epidemiology of errors.
- Infrastructure to improve patient safety.
- Information systems for improving patient safety.
- Knowing which interventions should be adopted to improve patient safety.
- Adoption of patient safety practices.
- Using patient safety information.
- Transition of care issues and patient safety.
- Maintaining vigilance for patient safety.
Another forum specifically designed to solicit clinician feedback on the proposed patient safety research agenda program plan was held in Chicago in November 2000. Information from this meeting was also used to craft AHRQ's research agenda on patient safety.
Background: Four Elements Supporting AHRQ's Patient Safety Initiative
Input from external sources and focused internal planning activities resulted in a broad, user-driven, action-oriented research agenda that was shaped into a national strategy for improving patient safety. AHRQ's intention is to go beyond simply describing and defining the problem of medical errors and threats to patient safety. The intent is to have a positive impact on patient safety by providing knowledge and tools to understand medical errors and to create solutions that mitigate or eliminate harm to patients suffered as a result of health care.
AHRQ's stated mission for its Patient Safety Initiative is to:
Identify, understand, and reduce the risk of harm associated with medical errors and health care system-related problems. This goal will be accomplished by eliminating or minimizing hazards known to compromise patient safety and increase the risk of injury to patients from health care.16
To support its initiative, AHRQ developed a long-term plan that includes four distinct elements. The plan requires sustained effort, and many projects span more than one element of activity.
AHRQ's research portfolio addresses questions such as when, how, and under what circumstances errors occur; how to develop the tools, data and training to answer future questions; and how to work with public and private partners to apply evidence-based approaches to the improvement of patient safety. As indicated in Chapter 1, AHRQ has adopted a multi-element model as the paradigm for the long range plan for patient safety. The four elements of activity are listed below and displayed in a matrix in Table 12.
- Element 1: Identifying threats to patient safety. Identify medical errors and causes of patient injury associated with the delivery of health care.
- Element 2: Identifying and evaluating effective patient safety practices. Identify, design, and evaluate practices that eliminate or mitigate the effects of medical errors and system-related risks and hazards which compromise patient safety.
- Element 3: Teaching, disseminating, and implementing effective patient safety practices.
- Educate health care providers, purchasers, patients, and policymakers about successful patient safety interventions and best practices.
- Disseminate information to a variety of users on the causes of and successful interventions to identify, reduce, eliminate, or mitigate the effects of error.
- Implement patient safety best-practices to reduce medical errors and improve patient safety.
- Raise awareness that patients are at risk for health care associated injury and harm (that is, harm caused by or associated with the delivery of health care).
- Adopt a positive patient safety culture.
- Element 4: Maintaining vigilance. Continually monitor and evaluate threats to patient safety to ensure that a positive safety culture is maintained and a safe environment continues. Such systems are absolutely necessary to ensure that interventions are achieving their objectives with no unintended effects.
Because the AHRQ Patient Safety Initiative began less than 2 years ago, most activity is focused on elements one through three. Even though efforts to improve the safety of health care delivered to Americans are well on their way, it is crucial to recognize that optimizing the safe delivery of health care is a multi-year endeavor. There is still much work to be done. Furthermore, AHRQ's efforts must be combined with those of others within DHHS, other Federal agencies, and the private sector.
Developing the Foundation: A Portfolio of Activities
While AHRQ initiated a focused call for patient safety research in FY 2000, it was not until FY 2001 that AHRQ received the $50 million appropriation which enabled the Agency to implement a large-scale Patient Safety Initiative. AHRQ received continued appropriations of $55 million in FY 2002 and $60 million in FY 2003 to carry out its Patient Safety Initiative. AHRQ uses a combination of grants and contracts to build and maintain its patient safety portfolio. With the award of these grants and contracts, AHRQ became the world's largest sponsor of patient safety research.
The following section briefly describes the major components within the context of the four distinct areas:
- Identifying threats.
- Identifying effective practices.
- Educating, disseminating, and implementing practices.
- Maintaining vigilance.
Table 12 shows the four elements of the Patient Safety Initiative and several of the major components of each element.
As an area of research, patient safety is in its infancy. Prior to the recent upsurge of activity, there have been some pioneering efforts but sustained research has been severely limited because of a lack of qualified researchers in the field and well defined research methods specifically directed at patient safety problems and issues. Research has been further hampered by a lack of basic knowledge about the epidemiology of medical errors.
AHRQ is addressing these shortcomings in patient safety research through activities to identify threats (i.e., understand the epidemiology of medical error) and build capacity for research and implementation of evidence-based interventions. Descriptions of the Agency's specific efforts to improve patient safety follow.
Centers of Excellence in Patient Safety Research
As called for in Recommendation 4.1 of the IOM's report To Err is Human,1 AHRQ sought to create Centers of Excellence in Patient Safety Research to support the development of multidisciplinary research teams to:
- Build the knowledge base on the scope and impact of medical errors, particularly for diverse care settings and populations.
- Identify the root causes of threats to patient safety and effective system approaches to prevent the occurrence of errors.
- Study the effectiveness of various interventions to capture information on medical errors.
- Evaluate the outcomes of promising interventions in a variety of health care settings.
Each of the three centers funded so far has a demonstrated capacity to fulfill the goals of this part of the initiative.
Research results from the Centers of Excellence are intended to enhance patient safety through fundamental and applied research, development of tools, conduct of demonstration projects, educational program development and implementation, and dissemination of results. Each center supports a broad, integrated, multidisciplinary, multi-project health services research program that brings together strong teams of experienced and new researchers. Each center has designed a process to share essential facilities, services, knowledge, and other resources. Together, the teams develop new methodologies and generate analytic measures for use across supported projects that assess factors leading to success in evaluating and monitoring patient safety, as well as factors leading to breaches in patient safety.
While we anticipated funding up to five centers, we found that the field was insufficiently developed, and only three centers were funded. The remaining resources originally allocated to funding the Centers of Excellence were shifted to support other portions of the Patient Safety Initiative including efforts to develop capacity for future Centers of Excellence in Patient Safety.
Developing Centers of Excellence in Patient Safety Research (DCERPS)
While there were a limited number of Centers of Excellence with established infrastructures that were able to begin conducting extensive multidisciplinary research in patient safety immediately, there were many organizations and institutions that had the potential to become major centers of research in patient safety. These institutions had conducted some patient safety research but needed additional funding to establish a more broad-based infrastructure and the multidisciplinary relationships necessary to expand capacity in order to become Centers of Excellence. AHRQ issued a solicitation to assist the developing centers, which are called DCERPS. The goal was to expand the Nation's capacity in patient safety research and implementation whether funded by AHRQ or others interested in patient safety, increase the patient safety knowledge base, and establish mechanisms to assure that new knowledge is incorporated into actual practice.
All DCERPS have completed their initial planning year and are now conducting one or more pilot studies. One DCERPS grantee has obtained additional grant funding from the National Patient Safety Foundation to conduct a project complementary to the one funded by AHRQ. Two members of two additional DCERPS have been approved for investigator initiated grants (R01s) enabling them to expand the research begun in their DCERPS projects. These three DCERPS have already met an Agency goal for this program by demonstrating the capacity to carry out research beyond the initial funding provided by AHRQ.
We anticipate that other DCERPS grantees will also become competitive in seeking continuing funding from a variety of sources including AHRQ to continue their patient safety research and implementation activities.
Established Networks for Patient Safety Research
AHRQ has established three research networks as a mechanism to carry out focused research in quality and health services research. They are the Integrated Delivery System Research Network (IDSRN), the HIV Research Network, and the Centers for Education and Research on Therapeutics (CERTs). These networks are important structural components to target research projects that take advantage of the unique capabilities of each individual network. It was a natural step to use these networks in conducting some of the AHRQ funded patient safety research.
The Integrated Delivery System Research Network
The IDSRN is a model of field-based research that links the Nation's top researchers with some of the largest health care systems to conduct research on cutting-edge issues in health care on an accelerated timetable. The IDSRN is used explicitly to capitalize on the research capacity of, and research opportunities occurring within, integrated delivery systems. The network creates, supports, and disseminates scientific evidence about what works and what does not work in terms of data and measurement systems and organizational "best practices" related to care delivery and research diffusion. AHRQ has contracts with nine IDSRNs that provide a cadre of delivery-affiliated researchers and sites to test ways to adapt and apply existing knowledge. The IDSRNs represent an excellent resource for studying risks and hazards to patient safety. Each year up to six patient safety research projects are conducted by the IDSRNs. As an example, projects have been completed or are underway to examine the role of leadership in:
- Enhancing patient safety.
- Examining the effect of using technology rules with computerized physician order entry.
- Validating AHRQ's patient safety indicators.
- Improving patient safety by improving compliance with clinical practice guidelines for diabetes management.
- Examining the relationship of provider characteristics to quality of care and medication errors in ambulatory care.
- Assessing ambulatory medication dosing errors in children.
HIV Research Network
The HIV Research Network includes 18 medical institutions that treat more than 16,000 patients with HIV disease and are located across the United States. Each institution assembles data on the clinical and demographic characteristics of their patients with HIV infection, the frequency of each patient's outpatient clinic visits, and the number of inpatient admissions. Participating institutions then send the information to the data coordinating center located at the Johns Hopkins School of Medicine. Information is consolidated into a single uniform database at the data coordinating center.
The HIV patient population is particularly vulnerable to risks and hazards in the process of care and represents a particular challenge to patient safety. Special funding for the study of patient safety in this important population is ongoing. For example, the patient interview schedule asks about possible adverse drug reactions and obtains information on the physician's response to these events. Other interview questions probe physician-patient communication regarding adherence and recognition of medication side effects. The medical record data provide information on rates of prophylaxis for Pneumocystis carinii pneumonia (PCP) and Mycobacterium avium complex (MAC). Analyses have been initiated that examine site variation in rates of PCP and MAC prophylaxis (for eligible patients). A network intranet site has been developed, on which members can exchange information on best practices instituted to minimize the risk of errors.
Centers for Education and Research on Therapeutics
The CERTs demonstration program is a national initiative to conduct research and provide education that advances the optimal use of therapeutics (i.e., drugs, medical devices, and biological products). The program, which consists of seven centers and a coordinating center, is administered as a cooperative agreement by AHRQ in consultation with the FDA. The research conducted in the CERTs program has three major aims:
- To increase awareness of both the uses and risks of new drugs and drug combinations, biological products, and devices as well as mechanisms to improve their safe and effective use.
- To provide clinical information to patients and consumers; health care providers; pharmacists, pharmacy benefit managers, and purchasers; HMOs, and health care delivery systems; insurers; and government agencies.
- To improve quality while reducing cost of care by increasing the appropriate use of drugs, biological products, and devices and by preventing their adverse effects and consequences of these effects (such as unnecessary hospitalizations).
Each of the seven CERTs actively engage in patient safety research through supplements to their core grants:
- One study is specifically designed to reduce errors in the use of medications that can affect cardiac repolarization (QT interval) and/or heart rate.
- An observational study is designed to measure the effects of selected medications, including naproxen, on risk of serious coronary heart disease.
- A third study seeks to determine the utility of error collection and prevention programs in the pediatric population.
- A fourth study is using a database to describe the frequency of events consistent with drug hypersensitivity (allergic-like) reactions.
- In a fifth study, the investigators are determining the frequency and patient-level determinants of receipt of urate-lowering medications among a sample of patients with asymptomatic hyperuricemia.
- In a sixth patient safety project, the investigators are studying methods to improve prescribing of medications that may cause Torsades de Pointes—a cardiac arrhythmia that may cause blackouts or even sudden death.
- In addition, two CERTs have additional patient safety grants, with one also serving as a Center of Excellence in Patient Safety and another serving as a health systems reporting demonstration grantee.
The CERTs program represents a powerful research network for conducting and developing research in the area of safety in the use of therapeutics.
An essential part of building capacity is assisting individuals to gain the skills that they need to become patient safety researchers. Through a series of established training grant mechanisms, AHRQ is granting dissertation support awards to young researchers who are working on their graduate degrees. The Agency also funds career development awards for junior researchers who show potential for patient safety research. In addition, AHRQ supports established researchers who wish to refocus their research in a new and emerging area like patient safety. AHRQ has set aside funds in its training grant program specifically to develop the capacity of new researchers in the field of patient safety. A total of nine training grants in patient safety have been funded. Examples of projects underway include investigation of the effect of medication errors in the pediatric intensive care unit, partnering with patients to identify adverse events, investigating the impact on patient safety of co-management using the hospital model, and investigating the effects of extended work hours on patient safety in intensive care units.
AHRQ WebM&M: Morbidity and Mortality Rounds on the Web
Morbidity and Mortality (M&M) conferences are routinely held in individual hospitals across the country to discuss specific cases that raise issues regarding medical errors and safety improvement. The findings from these hospital-specific M&M conferences are not routinely shared outside each individual hospital. This narrow sharing of information is a lost learning opportunity. To create a national forum to discuss and learn from medical errors, AHRQ saw the opportunity to use the Web to host national M&M conferences aimed at improving patient safety through analysis of anonymously submitted cases. AHRQ contracted with the University of California at San Francisco to carry out this vision.
The AHRQ WebM&M site offers the medical community a unique opportunity to learn about patient safety from the experiences of their colleagues across the country and around the world. The anonymity safeguards enable physicians to share their experiences without fear of reprisal. Their involvement educates other providers about how to prevent medical errors and improve patient safety. The AHRQ WebM&M displays five cases per month, one each in medicine, surgery, pediatrics, obstetrics/gynecology and a wild card category that may include cases from nursing, emergency departments, or pharmacy. One case each month is expanded into a "Spotlight Case" that includes an interactive learning module which features readers' polls, quizzes, and other multimedia elements. Practicing physicians may obtain continuing medical education credit by successfully completing the spotlight case and its questions, and trainees can receive certification. A PowerPoint® version of the spotlight case is available to download for educational use, such as in student teaching conferences or residents' reports.
The AHRQ WebM&M is already recognized as an important teaching and learning resource on medical errors. It is being used in hospitals and teaching facilities, and there are over 3,400 registered users (with voluntary registration) with the numbers continuing to grow. It fills a badly needed gap in training and education about medical errors and patient safety. It models a new way of thinking about and conducting the traditional M&M conference and it is a very public means of demonstrating how we can learn from errors. The Web site is at http://www.webmm.ahrq.gov.