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Written Statement

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National Summit on Medical Errors and Patient Safety Research

Panel 5: State Coalitions and Public Policy Advocates

Testimony of Randolph Peto, Massachusetts Coalition for the Prevention of Medical Errors


The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.

Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.

Disclaimer and Copyright Statements


The Massachusetts Coalition for the Prevention of Medical Errors is pleased to testify today on the critical research questions that must be answered to accelerate and advance a national patient safety agenda.

Massachusetts is at the forefront of a national discussion about how best to prevent medical errors. We are the first state in the nation to have formed a broad-based coalition of providers, clinicians, and regulators who are committed to working in a cooperative spirit to share information about the causes of errors and strategies for prevention.

And the Coalition is taking action with best practices, communication, and collaboration. Since the groupís formation three years ago, we have developed and disseminated best practices, a consumer pamphlet, and a series of safety alerts to address medication errors. We have also begun a series of new initiatives—focused on restraints, wrong-site surgery, and regulatory overlap and duplication.

Massachusetts has a wealth of expertise in quality improvement and error prevention in the membership of our coalition. Many of the recommendations from the Institute of Medicine (IOM) and Quality Interagency Coordination Task Force reports are underway in our state. Our collective experience has taught us that there is no quick fix but there are significant opportunities for improvement now. Whether we are fostering cultural change, making system improvements, implementing computer order-entry, or moving towards national reporting systems, it is important to recognize that these changes take time, resources, thoughtful study, and the active participation of the highest levels of leadership.

A unique opportunity exists for leadership at the national level in creating a new model of patient safety. The Agency for Healthcare Research and Quality could help us achieve our common goal by finding ways to fund research in initiatives and pilot projects that address the following critical questions:

What are the barriers to accelerating the use of best practices to prevent medical errors? Are the barriers institution specific, or related to broader systemic factors present in our nationís healthcare system? What are the strategies for working through these barriers?

There is a gap between the identification of evidence-based "best" practice in medical error prevention and the transference of that knowledge into "actual" practice. We know through recent studies that errors, while made by individuals, are often the result of faulty systems. Other industries have taught us that by incorporating principles to reduce human error into the design of work, the likelihood of errors will be greatly reduced. Yet, we are at the very early stages of this learning process. Research is needed to better understand how to apply these principles in a cost-effective way to the health care setting. We need to understand the barriers to implementing evidence-based practices and identify strategies for overcoming these barriers.

Much has been written about the prevention of medication errors, in particular, the effectiveness of computer physician-order entry (CPOE) systems to reduce medication errors. In 1999, the Massachusetts Hospital Association (MHA) and the Massachusetts Coalition for the Prevention of Medical Errors issued a set of recommendations to prevent medication errors. These recommendations were based on a survey conducted by the MHA in collaboration with the Institute for Safe Medication Practices to identify the different approaches used by hospitals in the administration of medications. This information, along with an extensive review of the literature, was used to develop a set of best practices to prevent medication errors. These practices have been widely circulated and are being adopted.

One of the long-term best practice recommendations involved the implementation of CPOE systems. However, successful implementation of this safety initiative is dependent upon a variety of factors, some beyond the control of the hospital. To better understand these factors, we have begun a pilot project to explore the feasibility of implementing CPOE systems in two mid-size community hospitals under the leadership of Senator Richard Moore, our stateís Senate Chair of the Health Care Committee. The focus of this project is to determine whether CPOE systems can be implemented in a cost-effective way in a community hospital environment and to create a template or pathway for other community hospitals to follow.

This process, while in its very early stages, has identified significant barriers of cost, physician buy-in, technological readiness, and interface problems between different computer systems. It has brought home the message to all participating that these problems need to be resolved before CPOE can be made universally available. We need research such as this to help identify barriers to implementation, and to develop cost-effective implementation models for facilities of different sizes and types. We also must identify the appropriate phasing in of a CPOE system; what features have the most return on improved safety with their implementation?

We also need research on the best ways to accelerate the use of non-computerized medical error prevention strategies or best practices. We need to find ways to build on the expertise of others in the field (e.g., The Institute for Healthcare Improvement). People have experience striking improvements with preprinted order sets.

We need to better understand the best ways to disseminate information on best practices to the health care field and provide opportunities for providers to share the lessons learned in implementing those practices.

Finally, as healthcare rapidly moves out of the inpatient setting, we must begin to take the lessons learned in the hospital and apply them to other healthcare settings. This research is critical to advancing the patient safety agenda.

What are the evaluation systems for determining the impact of patient safety initiatives?

We are in a new era of public accountability and there is no going back. We need to work publicly and collaboratively to reduce medical errors. Yet, finding ways of measuring the impact of our safety initiatives on error reduction is an enormous challenge. We must find ways of demonstrating that we are doing everything we can to make our system as error-proof as possible while simultaneously creating a safe environment that supports open dialogue about errors, their causes, and their solutions.

It would be very difficult to determine the impact of patient safety initiatives through the monitoring of error rates at the federal level with any scientific validity. One of the goals in the early years of the patient safety movement is to create a culture of safety, which would encourage the increased reporting of events so that the causes and solutions can be better understood. If we are successful, we expect to see the numbers of reported events go up, not down. Counting "events" to determine what impact, if any, may unintentionally result in an environment that is less likely to foster open reporting.

In addition, there is no universally standardized definition as to what constitutes a "medical error," which makes it extremely difficult to monitor error rates. We also do not know the true incidence of errors. It would be very difficult to set a certain percent reduction in errors and measure achievement, whether using a voluntary or mandated reporting database.

In the early days of the Coalitionís formation, we consciously chose not to collect data about errors or incidents. While the self-reporting of medical errors without fear was seen as a major hurdle that must be addressed, the confidentiality and immunity in dealing with medical errors and reporting requirements were recognized by all as controversial. To ensure that the Coalition did not get stuck on this issue, consensus was reached early on to focus on "best practices." It was felt that enough data were available through the literature, the state health department, the state board of registration in medicineís patient care assessment updates, and JCAHO to help target our error prevention strategies.

The Coalition is now faced with the challenge of how best to evaluate the effectiveness of our model. One of the ways we have approached this question is to survey hospitals to determine the progress that has been made in implementing the best practices to prevent medication errors. We expect to find hospitals at different stages in the journey with stories to share and hope to gather information about what kinds of tools are needed to help accelerate implementation. Research that focuses on the practical application of best practices is very much needed.

The Coalition has also experienced more subtle ways of evaluating the impact of the Coalition model on patient safety, which should be factored in to a national research agenda. For example, part of the Coalitionís mission was to elevate the discussion about errors and prevention to the highest levels in our organizations and make error prevention and patient safety a top priority throughout our state. We are well on our way towards achieving this goal. We have also begun to see a more cooperative spirit among providers and regulators.

Do existing cost-effective and secure mandatory reporting systems for errors that have resulted in patient harm, have an impact in terms of error reduction, i.e., do confidential systems actually make a difference?

Massachusetts has had mandated reporting for many years. We have two state reporting mandates with sometimes overlapping requirements and different confidentiality provisions. We have learned that mandated reporting by itself is not the answer. We have to take the lessons learned from these incidents and translate them into strategies that the health care community can use to prevent medical errors. We are beginning to do this through the work of the Coalition.

Secondly, the movement towards increased reporting by different state and federal agencies, JCAHO, and others is occurring at a time of enormous financial pressure for health care providers and agencies. As we move forward in the national debate over voluntary vs. mandatory reporting, confidential vs. public reporting, it will be important to avoid the creation of another layer of reporting, and avoid overlap and duplication. This will ensure that resources are focused where they should be—on making our healthcare system as safe as possible.

Thirdly, we do not know whether reporting has had an impact on patient safety or whether confidential reporting yields greater information than public reporting. Before pursuing a national mandated reporting agenda, it is important to evaluate the effectiveness of the current systems on patient safety. We need to better understand why existing systems are not being used to their fullest potential, whether broad or narrowly defined definitions result in the greatest yield, what the right balance is between public accountability and confidentiality, and how to promote a cooperative relationship between regulators and providers.

We also need to identify the best methods of analyzing reporting data and getting the lessons learned back out to the healthcare community in a timely fashion. Counting errors will do little to improve patient safety. The benefits of studying medical errors come from analyzing the events to learn how to reduce risk and to share that knowledge throughout healthcare. We also have learned that adequate funding is key, so we must have better knowledge of the cost implications of implementing these systems.

Despite the significant differences in state statute reporting requirements, is it possible to standardize a secure, near-miss reporting system so that we can learn from aggregate data?

Research is needed to fund pilot projects in the private sector or through public-private partnerships to determine the key factors for successful implementation of a secure, near-miss reporting system. Some of the questions that must be answered include: how large will the potential number of reports be submitted under a near-miss reporting system, and how expensive will it be to operate such a system? How will the data be analyzed and shared with the health care community? How will confidentiality be maintained? What are the protections that would have to be in place to foster candid reporting? Should it be voluntary or mandatory? Where will the data reside? Is it possible for coalitions of providers and regulators, such as the Massachusetts Coalition for the Prevention of Medical Errors, to constitute a model for regional-based reporting? Will confidential external reporting decrease the amount of internal reporting? We need to understand what type of systems would best serve the goals of patient safety.

Establishment of an effective non-punitive environment in healthcare institutions will require a dramatic culture change for institutions, professional licensing boards, accrediting bodies, and regulators: What are the extent of these changes? What should successful organizational and inter-organizational practice look like, and what are the steps to move these efforts forward now.

The IOM report has sparked a national debate about the role of institutional and individual accountability. As institutions move towards this new systems-based model, there is confusion about how to navigate individual accountability and the assessment of competency. Within institutions, considerable tension has emerged between individuals" perception of their own accountability (do no harm), informal comments by colleagues of individual actions, and discomfort among leadership in embracing a non-punitive environment.

Institutions and individuals are not the only partners in this new model. Professional licensing boards, accrediting agencies, and regulatory bodies have significant oversight responsibility for safety with a particular focus on the role of individuals. Even with todayís emphasis on the systems-based focus, there is a growing public demand for these agencies to more aggressively identify the poor performers in the healthcare industry.

There is also a perception that institutional and regulatory efforts are not aligned, may in some cases be strained, and lack good models of collaborative practice. It is often viewed that they stymie the work of each other and lead to frustrations throughout the industry. There is concern that while the institutions may be focusing responsibly on systems, "bad actors" are left untouched. When regulatory agencies focus on individuals, they may be perceived as being out of line with current systems thinking and making professionals adverse to candid disclosure.

There is a role for both individual and institutional accountability in this new model of error prevention. Researchers are just beginning to identify models for looking at the role of individuals in a systems based model. This work needs to be advanced and applied. Successful models of collaborative practice must be identified and shared. In their absence, new models of collaborative practice need to be developed in a fashion that encourages collaboration and risk sharing and protects all parties during the research aspects of development. Educational programs involving healthcare institutions, professional associations, and regulatory bodies need to be developed and held around the perspectives, capabilities, and needs of each.

The Massachusetts Coalition appreciates this opportunity to testify and is committed to working with the Agency for Healthcare Research and Quality and other organizations to move this important research agenda in patient safety forward.

Current as of September 2000


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