Chapter 3. AHRQ's Patient Safety Initiative: Breadth and Depth for Sustainable Improvements (continued)
AHRQ's Patient Safety Initiative: Building Foundations, Reducing Risk
Patient safety is a worldwide issue, and research activities related to patient safety are truly international in nature. As part of the capacity building and implementation process and to maximize shared learning, it is essential that AHRQ coordinate and integrate its research and development activities with those of other countries. Therefore, AHRQ has included international cooperation as an essential component in its overall patient safety research initiative. This cooperation began with inviting international representatives to the September 2000 National Summit on Medical Errors and Patient Safety Research. Representatives from New Zealand, Australia, and the United Kingdom participated.
Some of the most active and productive cooperative international activities are occurring between the United States and the United Kingdom. On October 10, 2001, Secretary of Health and Human Services, Tommy G. Thompson, and the United Kingdom's Secretary of State for Health, the Honorable Alan Milburn, signed an agreement to formalize the U.S-U.K. collaboration to improve the quality of health care. Cooperative activities have already been undertaken between the United States and the United Kingdom in the area of patient safety research and initiative activities. A working collaboration in patient safety now exists between the United States and the United Kingdom with established lines of communication and active cooperative activities. This collaboration has been ongoing since June 2001 and is accelerating its pace and accomplishments.
U.S.-U.K. activities include:
- Joint participation in research agenda building and review of research applications. There has been extensive participation between AHRQ and U.K. patient safety research teams in coordinating the activities in both countries.
- A representative from the United Kingdom sits on the steering committee of the Patient Safety Research Coordinating Center (PSRCC) funded by AHRQ. The PSRCC provides technical assistance to AHRQ and selected other patient safety grantees, facilitates sharing of information among patient safety grantees, and provides logistical support for AHRQ's annual patient safety conferences.
- The first transatlantic U.S.-U.K. Patient Safety Research Methods Workshop, "Patient Safety Methodology," was conducted September 8-10, 2002. The papers presented at this workshop have been published as a special supplement, Patient Safety Methodology, by the journal Quality and Safety in Health Care, volume 12, supplement 2, December 2003. Information on the U.S.-U.K. Patient Safety Research Methodology Workshop (Iceland September 8-10, 2002) is available at: http://www.publichealth.bham.ac.uk/psrp/pdf/iceland_report_revisedmar03.pdf.
- The second transatlantic U.S.-U.K. Patient Safety Research Methods Workshop, "Safety by Design," was conducted September 23-24, 2003. The papers from this workshop will also be published in Quality and Safety in Health Care.
In addition to the activities with the United Kingdom, AHRQ has established informal networks with international patient safety researchers in a variety of countries including Australia, Canada, Denmark, France, Germany, the Netherlands, New Zealand, Norway, Sweden, and Japan. Because patient safety is a worldwide issue, the United States has much to learn from other countries.
- The Evidence Report/Technology Assessment Number 43, Making Health Care Safer: A Critical Analysis of Patient Safety Practices19 has been translated into Japanese.
- AHRQ has given permission for MedWave and Nikkei BP to translate the AHRQ WebM&M into Japanese and set up a direct link to the AHRQ WebM&M site. MedWave is a specialized medical Web site for the Japanese medical and nursing professions representing more than 36,000 subscribers who receive subscriptions free of charge. Nikkei BP publications reach a combined readership of over 2.9 million with annual magazine circulation exceeding 52 million.
Patient Safety Improvement Corps (PSIC)
An essential part of building capacity is training State departments of health teams, which include their selected hospital partners, in techniques useful in identifying potential risks, analyzing medical error reports using tools such as root cause analysis, and developing and implementing effective, sustainable interventions. The primary goal of the PSIC training is to:
- Provide State-selected teams in the field (e.g., patient safety officers or those responsible for analyzing reported errors and developing effective, sustainable interventions) the knowledge and skills to identify risks, conduct valuable investigations of medical errors by identifying their root causes with an emphasis on systems issues.
- Prepare meaningful reports on their findings.
- Develop, implement, and sustain system changes based on report findings.
- Measure their impact on safety (i.e., the elimination or reduction of hazards leading to improved patient safety) once those changes have been implemented.
Given the VA's experience in conducting education programs for the residents treating patients in the VA system and other hospital staff in this country and elsewhere, AHRQ is using an interagency agreement with the VA to develop and implement this program for State staff and their selected hospital partners. The VA will be able to call on other Federal sector safety and patient safety faculty expertise including AHRQ, the National Aeronautics and Space Administration, and the Uniformed Services University of the Health Sciences.
The training program will take place in three 1-week sessions over a 9-month period and include concepts such as patient safety science (introductory and advanced), human factors, measurement (including descriptive statistics), evaluation, organizational theory, safety culture, change implementation and management, medical errors reporting and analysis, and medical-legal issues. Training tools will also be included and focus on root cause analysis (using a variety of methods and including the identification of the strengths and weaknesses of each method), health care failure mode and effects analysis, probabilistic risk assessment, AHRQ's patient safety indicators, and medical errors reporting.
Participants will complete a project during the program. Evaluation of students, faculty, and the overall program will be conducted. Over time, this initial training program will be converted to compact disk- and Web-based mediums with specific face-to-face training moving to a train-the-trainer program. In addition to State staff and their selected partners, this program will likely be opened to other Federal agency staff (e.g., DoD, CMS, and private-sector quality improvement organizations funded by CMS).
Patient Safety Task Force
Since other Federal agencies consider patient safety a high priority, the Secretary of DHHS officially announced the establishment of a Patient Safety Task Force (PSTF) in April 2001 at the National Summit on Patient Safety Data Collection and Use. The PSTF's mission is to coordinate research and analysis efforts, integrate existing data collection on medical errors and adverse events, and collaborate on reducing the occurrence of injuries that result from medical error. The PSTF brings together AHRQ, CDC, the CMS, and the FDA to integrate and coordinate their activities related to patient safety and the reduction of medical errors.
The PSTF concentrated its initial efforts on the integration of Federal reporting systems. In this effort it has involved the stakeholder community of users of data both from a reporting and analysis standpoint. The summit established priorities for a national patient safety network and database. As in all other major patient safety projects, user and stakeholder input from such organizations as the American Hospital Association, American Medical Association, State departments of health, and risk managers had a primary consideration in the planning, development, and implementation of the national patient safety network and database.
Recent efforts to reduce costs and streamline the delivery of care have led to significant changes in the health care workplace. These changes in working conditions have affected health care workers. Kovner points out that these conditions have had a negative effect on the quality of the care provided.20 Because the experience of other industries indicates that differences in the equipment and physical characteristics of the work space, changes in work process, and differences in staffing can affect the quality of the products or services they produce, it is reasonable to hypothesize that changes in the health care workplace may be affecting the quality of care.
Increasing our understanding of how working conditions affect health care workers and the resultant risks of errors and quality of services for patients is of major importance to the health care industry, particularly for those who manage or oversee health care organizations, and set policies that affect the physical or organizational working conditions of health care workers. Research is needed to understand if workplace conditions actually affect quality and if so, how quality is affected and how successful interventions can be encouraged.
In collaboration with other Federal agencies involved in the QuIC, AHRQ has held two conferences to seek evidence documenting the effects of key elements of working conditions such as staffing levels, working hours, physical environment, workflow design, and organizational culture on the quality of care provided to patients. These conferences demonstrated that while research has linked many aspects of working conditions to the quality of the goods or services produced in other industries, there have been limited studies done in the health care field.
Therefore, the Agency has funded grants to:
- Explore the relationship between working conditions that effect health care workers and the safety and quality of care they provide.
- Test innovative approaches to working conditions that have been effective in improving the quality of a product or service in industries other than health care.
These grants are identifying, characterizing, and directly measuring the effect of the health care work environment on the safety and quality of care provided by health care workers. A total of 22 working conditions grants are being funded that focus on quality or safety.
An AHRQ-sponsored evidence report, The Effect of Health Care Working Conditions on Patient Safety,21 was released March 2003. While this report highlights the need for further research, the findings from this report suggest that evidence exists to support several recommendations related to working conditions and the delivery of health care. Findings include:
- Strategies to increase staffing levels of licensed and unlicensed nurses in both acute-care hospitals and nursing homes will likely lead to improved patient outcomes.
- Preventable complications are lower when complex technical procedures are performed by physicians who conduct them frequently (i.e., high-volume physicians).
- Duration of experience of the health professional is associated with better patient outcomes for some types of clinical care.
- Systems to reduce interruptions and distractions will likely reduce the incidence of medical errors.
- Systems to improve information exchange, transfer of responsibility, and continuity of care between hospital and nonhospital settings ("hand offs") decrease medication errors, and, in some settings, hospital re-admissions.
Initial research on patient safety was investigator initiated, and this work has created a foundation for current research. AHRQ has funded a number of investigator-initiated grants as part of its overall research initiative and continues to support such research. Investigators apply for funding using AHRQ's established program announcements (PA) and not the funding opportunities specified in a Request for Applications (RFA). There are two types of grant opportunities for investigators: small research (R03) grants with a maximum of $100,000 per year for 2 years, and regular large grants (R01) with a maximum of $500,000 per year in direct costs. The small grants help investigators test new research methods and conduct pilot type projects. The R01 grants are intended to sponsor large scale studies with established approaches to research methods and design. Over the past 2 years, AHRQ has funded a number of small and large grants in patient safety outside the six designated RFAs. They include studies of sleep and fatigue's impact on medical errors, risk communication, hospital-reported medical injuries, reducing adverse drug events, and the effects of extended work hours on patient safety just to name a few.
Raising Awareness: Dissemination and Outreach Efforts
One important element of dealing with medical errors is raising awareness of their existence. The publicity surrounding the release of To Err is Human and the press coverage occurring since that time have raised awareness about the problem of medical errors and patient safety. But a great deal of information sharing about those issues is needed to raise awareness about the complexities of medical errors and patient safety. AHRQ has initiated three types of activities directed at raising awareness:
- A dissemination and education grants program.
- A conference program.
- The User Liaison Program (ULP).
Systems-related Best Practices Grants
Within weeks of the IOM's release of To Err is Human, AHRQ issued a research solicitation focused on projects designed to improve patient safety by identifying and preventing avoidable system errors. Six patient safety projects resulting from this solicitation were funded in 2000. The projects and institutions receiving awards follow:
- Virginia Commonwealth University: Characterizing Medical Error: A Primary Care Study.
- New England Medical Center: TIPI Systems to Reduce Errors in Emergency Cardiac Care.
- University of Maryland: Brief Risky High-Benefit Procedures: Best Practice Model.
- Stanford University: Developing Best Practices for Patient Safety.
- Brigham and Women's Hospital: Improving Safety by Computerizing Outpatient Prescribing.
- University of Texas Medical School-Houston: Teamwork and Error in Neonatal Intensive Care.
These projects were completed in September 2003 and provide major contributions to the knowledge base in patient safety.
Clinical Informatics to Promote Patient Safety (CLIPS)
Clinical informatics applications for improving patient safety represent an important area of research for patient safety. To study these issues, on February 21, 2001, AHRQ issued an RFA on the use of clinical informatics and information technology (IT) to reduce medical errors and improve patient safety. Specifically, AHRQ sought projects to develop and test the use of innovative technologies, such as hand-held electronic medication and specimen management systems, training simulators for medical education, computerized bar-coding, patient bracelets, smart cards, and automated medication dispensing systems in clinical settings. The main objective of the RFA was to assess the extent to which such innovations, when applied in various health care settings, contribute to measurable and sustainable improvements in patient safety.
Research resulting from this RFA should help all users of the research better understand the opportunities and barriers to using IT to improve the safety of health care. Funded projects were required to use rigorous scientific methods to assess the effect of the IT innovation on medical error rates and other measures of patient safety. These projects are evaluating IT tools that alert providers to information that may be critical to the provision of high quality care, develop strategies to address barriers to successful adoption of innovative IT applications, document the costs and resources associated with the IT applications, or evaluate transferability to other settings. Eleven grants were awarded for a 3-year period with a closing date of September 2004.
Table 13. Funded CLIPS Grants
|Principal Investigator (PI)||Institution||Project Title|
|Novak, Richard M.||University of Illinois at Chicago||HIV treatment error reduction using a genotype database|
|White, Richard H.||University of California Davis||Informatics Tools to Reduce Warfarin Errors|
|Hripcsak, George||Columbia University Health Sciences||Mining Complex Clinical Data for Patient Safety Research|
|Galt, Kimberly A.||Creighton University||Personal Digital Assistant Devices and Medication Error|
|Cook, Richard I.||University of Chicago||Linking User Error to Lab and Field Study of Medical IT|
|Berner, Eta S.||University of Alabama at Birmingham||Improving Primary Care Patient Safety with Handheld DSS|
|Lapane, Kate||Brown University||Pharmacist Technology for Nursing Home Resident Safety|
|Lozano, Paula||University of Washington||Using Handheld Technology to Reduce Errors in ADHD Care|
|Fried, Marvin P.||Montefiore Medical Center (Bronx, NY)||Identifying and Reducing Errors with Surgical Simulation|
|Johnson, Kevin B.||Johns Hopkins University||Electronic Prescribing—Medication Errors in Pediatrics|
|Teigland, Christie L.||Foundation for Long Term Care||Using Prospective MDS Data to Enhance Resident Safety|
Identifying Proven Safe Practices
Ensuring patient safety involves identification of safe practices and establishing operational systems that will minimize, in the long run, the likelihood of medical errors and their adverse consequences. A safe practice is a type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures. Two examples of AHRQ's research-to-implementation activities follow.
Making Health Care Safer: A Critical Analysis of Patient Safety Practices
As part of identifying effective practices, AHRQ commissioned a systematic review of patient safety practices by the University of California at San Francisco-Stanford University Evidence-based Practice Center. The report, Evidence Report/Technology Assessment Number 43, Making Health Care Safer: A Critical Analysis of Patient Safety Practices,19 identified a total of 79 practices for review and discussion. This report received a tremendous amount of attention and there were several thousand requests for it over the past 2 years. It represents the first compilation of patient safety practices supported by a review of the related evidence behind them.
A number of clear opportunities for safety improvement were identified in the report (e.g., use of perioperative beta-blockers to prevent perioperative morbidity and mortality, use of real-time ultrasound guidance during central catheter insertion to prevent complications, appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk). A number of practices in which further research is likely to be highly beneficial were also noted (e.g., use of silver alloy-coated catheters to prevent hospital acquired urinary tract infection, use of perioperative glucose control and supplemental perioperative oxygen to prevent surgical site infections, anticoagulation services and clinics for anticoagulation treatment using Coumadin).
Evidence of the response to the report is found in two editorials published in the Journal of the American Medical Association,22,23 that discussed various aspects of the evidence-based approach used in crafting the report. As these editorials in the medical literature demonstrate, there is an active interest in exploring safe practices for improving patient safety. The report has served as a starting point for determining what evidence-based safe practices have likely benefits but need further research and which practices institutions might consider adopting.
Safe Practices for Better Health Care
As health care institutions struggle with the issue of patient safety and seek solutions, we noted a need for recommendations on what safe practices should be adopted to make health care safer. AHRQ and CMS asked the National Quality Forum (NQF), to develop a set of recommendations for safe practices. The NQF is a not-for-profit membership organization created to develop and implement a national strategy for health care quality measurement and reporting. The NQF, a national standards setting organization, could make recommendations to be used by other organizations seeking guidance on adoption and implementation of safe practices. The NQF used the EPC report noted above as a starting point for the consensus development process, and supplemented it with information from several other sources.
To provide a pragmatic and structured method for consistently assessing candidate safe practices, all practices were evaluated based on the following five criteria: specificity, benefit, evidence of effectiveness, generalizability, and readiness. A final set of 30 practices demonstrated to be effective in reducing the occurrence of adverse health care events was created. The practices are organized into five broad categories for improving patient safety by:
- Promoting a culture of safety.
- Matching service delivery capabilities to health care needs.
- Facilitating information transfer and clear communication.
- Adopting safe practices in specific clinical settings for the specific processes of care.
- Increasing safe medication use.
The NQF Safe Practices for Better Healthcare24 was released January 30, 2003.
Safe Practices Implementation Challenge Grants
In April 2003, AHRQ and the Patient Safety Task Force announced the availability of FY 2003 funds ($3 million) to assist health care institutions to:
- Assess risks and known hazards to patients in the process of care leading to preventable injuries or harm, and devise intervention strategies.
- Implement safe practices that show evidence of eliminating or reducing the known risks and hazard associated with the process of care.
Under this cooperative agreement, AHRQ will provide up to 50 percent of the total cost of the projects, and the grant recipients are required to provide a minimum of 50 percent of the total cost. The Agency received 117 applications, unprecedented in AHRQ's history for a single request for proposal. The level of enthusiasm and interest from universities, hospitals, clinics, faith-based organizations, and State and local government agencies was most impressive and demonstrates the interest and the need to facilitate implementation of evidence-based safe practices that eliminate identified hazards and/or reduce the risk of harm to patients. AHRQ made a total of 13 awards: six 1-year risk assessment projects and seven 2-year implementation projects as part of the challenge grant program.
Risk Assessment Grants
- Boston Medical Center, Boston, MA: $200,000.
- St. Jude Children's Research Hospital, Memphis, TN: $200,000.
- Beth Israel Deaconess Medical Center, Boston, MA: $199,968.
- Veterans Medical Research Foundation, San Diego, CA: $187,895.
- Oregon Department of Human Services, Portland, OR: $165,205.
- University of Chicago, Chicago, IL: $139,400.
- Sacred Heart Medical Center Foundation, Eugene, OR: $498,720.
- University of Missouri-Columbia, Columbia, MO: $470,620.
- Johns Hopkins University, Baltimore, MD: $454,590.
- Kaiser Foundation Research Institute, Oakland, CA: $443,767.
- University of Iowa, Iowa City, IA: $400,000.
- Cincinnati Foundation for Biomedical Research and Education, Cincinnati, OH: $327,721.
- University of Wisconsin-Madison, Madison, WI: $270,175.
Total Awards: $3,958,061.
QuIC Error Workgroup Activities
Within the structure of the QuIC there are a number of workgroups that provide a framework for interagency cooperation to address specific problems of patient safety and quality. One of these workgroups is the Errors Workgroup, which has been meeting regularly and has identified several agenda items concerning specific patient safety issues and methods for responding to known hazards to patient safety. The group has identified specific projects including the development of patient safety measures and an evaluation of DoD team training activities.
Development of Organizational Safety Culture Instrument
Organizational culture is a key element in the success of any patient safety program. If the organization's culture is not supportive of efforts to improve patient safety and there is distrust in critical areas such as reporting of events, patient safety improvement efforts are likely to fail. The QuIC Errors Workgroup has been revising existing culture surveys to provide a valid and reliable instrument that is in the public domain and can be used by health care institutions. The safety culture survey has been pilot tested and is now available for distribution and use by health care organizations as a public domain instrument. The DoD and the VA plan wide use of the instrument and there is interest in using the instrument in the United Kingdom as part of their National Patient Safety Agency activities.
Evaluation of DoD Team Training Activities
Interdisciplinary team training is specifically addressed in the IOM's To Err is Human (Recommendation 8.1). There has been little external, independent evaluation of team training programs in health care to date. The DoD currently funds a number of team training activities in health care which are applying the principles and practices of crew resource management in aviation to patient safety. The DoD requested that AHRQ conduct an independent evaluation of DoD medical team training programs which are prototypes with the potential for wide application outside the DoD. Thus the opportunity exists to use the evaluation process to identify a model approach to the evaluation of any medical team training program that is applying crew resource management principles and practices to the health care setting.
In addition, this project has developed an evaluation model and tool kit of sufficient breadth to be applicable to multiple medical domains. As the last step, a program evaluation of three separate medical team training efforts in the emergency department, family practice, and obstetrics settings within DoD using the assessment instruments and evaluation model/toolkit will be conducted. The materials and reports of this project are being distributed nationally.
In carrying out the patient safety research agenda, it became clear to AHRQ that there was a need for greater coordination and evaluation than typical on smaller scale research initiatives. The use of external coordination and evaluation services through contracts has proved to be highly effective at a number of research agencies in DHHS, including the National Institutes of Health. With this experience in mind, the Agency determined to create two centers to provide support services to the Agency for the patient safety portfolio—an AHRQ Patient Safety Research Coordination Center (PSRCC) and an AHRQ Patient Safety Initiative Evaluation Center.
Summary of AHRQ's Patient Safety Initiative
AHRQ has successfully built the foundation for a national Patient Safety Initiative that addresses the issues and recommendations outlined by the IOM report To Err is Human which are in the Agency's control.
We must remember that the field of patient safety is in its infancy and, as we move forward, we are challenged to maintain and enhance the momentum. It is not an easy task—it is a long-term endeavor. Significant progress has been made and AHRQ is well positioned to move the Patient Safety Initiative forward.
While our Centers of Excellence are doing outstanding work, we must provide opportunities for new resources to explore the basic science of medical error and patient safety. We have a strong group of developing centers (DCERPS), some of which are already proving that they can compete for other funding from AHRQ and elsewhere. Research exploring the impact of working conditions on patient safety and the quality of care will produce important findings that can and will be used to improve the safety of patients. We have established an effective working relationship with patient safety researchers and program personnel in the United Kingdom, and there is a growing network of researchers internationally who are collaborating in addressing the issue of patient safety.
We are building the foundation and addressing the need for training professionals to work in the field of patient safety with our training grants and the new Patient Safety Improvement Corps (PSIC). Conducting this program in cooperation with Federal partners is an example of addressing significant issues in a cooperative and cost-effective manner. Without such training efforts and the investment in human capital to help combat medical error, the momentum cannot be sustained. By focusing training on those who can apply the approaches in their local areas and home institutions and teach others, the PSIC has the potential to result in broad implementation of proven safety practices.
We now have recommendations for safe practices that health care organizations can select to help reduce the risk of harm and improve the process of care. Both the report of AHRQ's Evidence-based Practice Centers, Making Health Care Safer: A Critical Analysis of Patient Safety Practices,19 and the recommendations of the NQF are necessary first steps. While additional strategies are being developed, attention to implementation is also needed. The Patient Safety Challenge Grants program implemented in FY 2003 is a major step in moving from identifying threats to identifying effective practices and implementing, monitoring, and evaluating them.
We also need to concentrate on implementing patient safety data standards for reporting systems so that we do not create data graveyards of incompatible patient safety data and reporting systems that do not allow information to be used as an error management resource. AHRQ and its partners in the Patient Safety Task Force have made great strides in integrating the separate and often isolated reporting efforts. Within DHHS, the efforts of the Patient Safety Task Force are a dynamic example of Secretary Thompson's One Department concept. The Patient Safety Network is the foundation of a national reporting system that can link together not only Federal reporting efforts but those of various States and private groups for improved patient safety.
Combating medical errors and ensuring continuous improvement in the safety and quality of health care require commitment and resolve. There are a growing number of dedicated leaders, health professionals, consumers, and patients who are working hard to achieve a new level of safety in U.S. health care. Human error will always be a fact; however, as a Nation, we must embrace a vision of minimal injury associated with the delivery of health care. Systems must be developed and implemented to eliminate, reduce, or mitigate the impact of error. With the commitment of patient safety funders, researchers, and practitioners, we can improve patient safety and achieve that vision.