While the IOM report offered many useful recommendations for improving the safety of the health care system, additional actions can and should be taken to reduce errors. Federal agencies have been working on a variety of projects designed to reduce medical errors and, in many instances, are the national leaders in experimenting with programs intended to promote safety. A brief description is provided below of some of the current activities, as well as recommendations for additional activities to reduce errors through increased awareness of medical errors; commitment of substantial resources to further research; the use of information systems; and the redesign of systems, procedures, and medical products.

Building Public Awareness of Medical Errors

Well-informed patients are key participants in the effort to enhance the quality and safety of American health care. The right question from a patient at the right time may be the intervention that averts an error. As the IOM report recognizes, the public largely believes that it is protected from errors and safety problems. For instance, the public assumes that licensure and accreditation confer a "Good Housekeeping Seal of Approval" on practitioners and institutions (Institute of Medicine, 1999). Thus, the public assumes that they can implicitly trust those professionals and facilities to do the right thing in the right way. Despite health professionals’ best attempts to make patients’ assumptions a reality, the available evidence about medical errors suggests that reality falls short. In that respect, patients’ understanding of the medical errors situation is not substantially different from their understanding of other confusing aspects of the health care system. For example, the Employee Benefit Research Institute (EBRI) reports that only 21 percent of managed care participants know they are in this type of plan. Instituting a national patient safety electronic bulletin board, as indicated in "Learning from Errors" in Chapter 2, will not only enable patients to report errors that they see or experience, but will also aid in improving the public’s general understanding of patient safety.

Although some members of the public are aware that the health care environment itself is less safe than previously assumed, they have made few demands for improvement of the system. A 1997 survey by the National Patient Safety Foundation found that many people view errors as a problem that can be fixed by getting rid of bad providers, rather than as the consequence of delivering care within a complex delivery system.

Clearly, an ongoing, aggressive public information and education effort is needed to increase all Americans' understanding of both how medical errors occur and what steps they can take to prevent such errors. This campaign must carefully address the tension between the need for increasing general awareness with the competing need of ensuring that patients are not afraid of receiving necessary care.

The QuIC agencies, working in close collaboration with private-sector organizations, can develop consistent patient safety messages and themes that can be used by Federal agencies and private-sector employers, health care purchasers, and others to disseminate a powerful and consistent message to individuals about their role in ensuring the quality of their own health care. The QuIC has established the Enhancing Patient and Consumer Information working group with the specific intent of providing the public with clearer and more consistent information about health care quality—and patient safety is a key part of that information. The QuIC agencies see this work group as a foundation for strengthening the effectiveness of the actions that agencies might have otherwise taken independently.

In particular, Federal agencies that provide or purchase health care have a responsibility to work with their constituencies to increase awareness of patient safety issues and the role their constituents can play in improving safety. For instance, part of HCFA’s and OPM’s mission in purchasing health care is to provide information to enrollees that will help them choose their health coverage. These agencies are exploring how to educate enrollees so that they can understand and evaluate issues related to medical errors and take appropriate actions. HCFA and OPM also lead the QuIC working group on patient and consumer information, which provides a natural vehicle for extending the messages to other Federal beneficiaries and the public.

A number of other mechanisms exist to extend the work of this work group to more people. It is possible to use public–private partnerships to communicate the patient safety message to a variety of audiences through recently developed mechanisms. These partnerships include the NPSF, NPSP, and the Quality Forum, and are summarized in the "Actions" section that follows.

• Through the QuIC’s Enhancing Patient and Consumer Information Working Group, led by OPM and HCFA, Federal agencies will develop and coordinate an information campaign for their constituencies and beneficiaries to increase their awareness of the problem of medical errors and patient safety.
• AHRQ will develop generic material for the public on preventing medical errors that Federal agencies can disseminate, reprint, or adapt. This material will enable patients to become more involved in their care and to be more active participants in the decisionmaking surrounding their care.
• The CQuIPS will develop and test patient safety questions for inclusion in the patient survey now being developed for provider-level assessment of health care.
• HCFA will conduct research aimed at shaping programs to educate beneficiaries about medical errors.
• Within 1 year, FDA will increase collaborative programs with patient and consumer groups regarding patient safety.
• FDA will enhance its interactions with the public through meetings with consumer and patient organizations, and through grass-roots informational meetings. The meetings will focus on patient needs and the safe use of medical products, particularly for home use. The meetings will also discuss how to reach patients with important information on safe use of medical products—including through the use of local networks, the Internet, and electronic and print media. This will occur within 1 year.
• Patient safety and reducing medical errors will be a featured topic at OPM’s Fall 2000 annual health plan conference.

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Building Purchasers’ Awareness of the Problem

Just as with Federal purchasers of health care, it is critical that employers who sponsor group health plans understand that quality, not just cost, is a factor to be considered in selecting health care providers for their employees. In 1998, the DOL’s Pension and Welfare Benefits Administration (PWBA) issued a letter making clear that, where the selection involves the disposition of employee benefit plan assets, taking quality into account is part of a plan decisionmaker's responsibility under the Employee Retirement Income Security Act (ERISA).

To assist employers in meeting this obligation, the DOL launched the Health Benefits Education Campaign in December 1998. One of the goals of the Campaign, a coalition of the DOL with both public- and private-sector partners, is to inform employees about issues of quality and safety under their employer-provided health benefits so that they can make informed health benefits decisions. The Campaign further seeks to inform employers of the value of providing quality and affordable health benefits to their employees. It provides a forum for sharing with the private sector the information learned from other QuIC agencies on quality care, setting and implementing standards, developing and implementing data integration techniques, and effectively communicating with consumers.

A number of employers and employer health care coalitions are already taking the initiative of making safe medical practice an important criterion in selecting the health insurance they provide to their workers. For example, the National Business Coalition on Health (NBCH), a Campaign partner, is developing a set of standards that employers can voluntarily use to evaluate safety and quality in health plans. The Business Roundtable, another Campaign partner, has allocated funds for the Leapfrog Group, an organization of eight executives of some of the Nation’s biggest companies and health care purchasers, including OPM, to encourage all employers to make safety and quality in health care a top priority. DOL will, through the Campaign, work with plans, employers, and participants to advance the provision of safe, high-quality health benefits. Some of the work that is being done is summarized in the "Actions" section that follows.

• Building on existing relationships with purchasers and business coalitions, such as the National Business Coalition on Health, and the Washington (DC) and Midwest Business Coalitions on Health, DOL, HCFA, OPM, and AHRQ will spearhead the QuIC’s efforts to promote collaborative programs with other public- and private-sector partners to increase purchasers’ and providers’ awareness of medical errors as a health care problem and of steps that each can take to address this problem, such as addressing patients’ health literacy skills.
• At the Federal Benefits Conference (June 2000), OPM will share information about patient safety with representatives from Federal agencies throughout the Nation.

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Working With Providers to Improve Patient Safety

In addition to information for patients and purchasers, information is needed for health professionals, facilities, and systems of care to ensure that they understand the scope of the medical errors problem and its impact. Results from surveys and focus groups conducted by VA, involving both VA and private-sector facilities, have shown that a substantial portion of doctors, nurses, and others working in health care facilities do not believe that medical errors present a significant threat to patients. If they believe that medical errors and issues of patient safety are isolated, random events, efforts to reduce the current incidence of preventable errors will not be successful.

The public’s perception is that the health professional credentialing and institutional accreditation processes provide meaningful assurances of the quality of care. It is crucial that professional societies, accrediting bodies, and licensure organizations use their roles to promote patient safety by ensuring that those whom they credential and accredit are knowledgeable about issues of safety and implement procedural changes that have been shown to reduce the likelihood of error. Help by these organizations is paramount in fostering awareness and understanding of issues about medical errors and patient safety.

The QuIC agencies will work collaboratively with professional societies to promote awareness of the medical errors problems and to identify ways to improve the education, credentialing and accrediting processes to rigorously examine safety knowledge and practices. AHRQ will work with private-sector groups, such as NPSF, NPSP, and the Quality Forum to educate providers and purchasers about improving patient safety.

• Through the QuIC, Federal agencies will take advantage of existing resources to promote collaborative patient safety programs involving agency constituents, the health professions community, the public, academia, and other stakeholders, such as the American Medical Association, the American Nurses Association, NPSF, NPSP, and the Quality Forum.
• VA will develop and run pilot patient safety education programs for medical residents and students.

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Using Decision-Support Systems and Information Technologies

The Federal Government has played a pivotal role in the application of information technology to health care. The predecessor of AHRQ funded some of the earliest research on computerized patient records, studies evaluating the impact of computer reminder systems on laboratory testing errors, and research on the effect of computers on drug ordering. VA and DoD are recognized national leaders in the implementation of electronic medical records and decision-support tools. They have recently joined in partnership with the Indian Health Service (IHS) to develop a prototype for a computerized medical record system. In addition, many private-sector leaders in health care informatics, such as Intermountain Healthcare and the Brigham and Women’s Hospital, have used Federal grants to develop and test their systems. The President has also requested $20 million in the FY 2001 Budget for the Health Informatics Initiative, which includes support for strategies to address the problem of medical errors through enhanced information technology.

Although the success of health care informatics models is well documented and their applicability to patient safety is clear, they have not been widely adopted. A Federal effort to further knowledge about the application and effectiveness of these technologies to patient safety improvement and to promote the appropriate adoption of these tools would build on a strong foundation of prior work and put health care technologies to use in improving the quality of care for Americans.

One example of where the QuIC could have an impact through its participants’ activities is in the area of electronic records and order entry. Most health care providers currently work with handwritten patient notes, which are often difficult to read, not readily available, incomplete, and prone to alteration, destruction, and loss. Electronic medical records and interactive decision-support tools have the potential to allow health care providers timely knowledge of a patient’s health history and improve clinical care. Electronic access to a patient's chart removes uncertainties regarding the patient's health history. Further, well-designed electronic systems can give physicians, nurses, and other providers essential access to the most current results of consultations, laboratory tests, x-rays and other studies, and to previous test results. Structured, electronic order entry systems that require complete data entry remove ambiguities that arise from incomplete information or illegible writing.

Moreover, real-time decision support constitutes a powerful technology that can help address the significant problem of medication errors. Decision-support systems can intercept errors, such as interactions between incompatible medications and the prescription of drugs to which the patient's electronic medical record notes an allergy. Patient factors relevant to the dosing of particular medications can also be evaluated electronically; drug overdosing or underdosing can be corrected by accounting for a patient’s age, weight, and kidney function. Taken further, better choices of medications for a particular condition can be recommended, such as the most diagnosis-appropriate antibiotic. Finally, bar-coding of medications and use of robotics in dispensing medications can ensure that the appropriate medication is provided to the appropriate patient at the appropriate time.

Health care organizations can more easily and reliably aggregate their electronic records to look for trends and provide data for research on patient safety issues without relying on costly chart reviews. Provider profiles can be used to provide helpful feedback to clinicians and to identify needs for training and system changes. Health care organization profiles can be developed for any level of the organization to look for systemic problems and evaluate interventions.

However, there is a real need to involve clinicians and other users in the design of systems at an early stage to optimize usability. Increased emphasis on design controls for manufacturers is needed to ensure that usability testing occurs throughout development, especially in the premarket design phase of medical device development. Continued development, taking into account knowledge of human factors and results of usability testing, is needed. Use of human factors standards, such as nationally or internationally accepted standards for products and the human factors standards used by NASA and DoD, could aid in that process.

Information technology has tremendous potential to reduce errors in health care by providing information when it is needed, providing clinical feedback, and alerting providers to potential problems. But, as noted earlier, information technology also has the potential to cause errors. Therefore, attention to human factors and other aspects of system design is vital. Additional research is needed to explore the safety and effectiveness of, for example, decision-support systems embedded in software and other technical aspects of medical products.

• AHRQ and CDC will expand research efforts in the area of informatics to include initiatives aimed at developing and evaluating electronic systems to identify, track, and address patient safety concerns.
• CQuIPS at AHRQ, along with VA, DoD, FDA and other QuIC member agencies, will evaluate the effectiveness of automated physician order-entry systems in hospitals.
• DoD, VA, and IHS will introduce electronic patient records to offer structured documentation and a common clinical lexicon for practitioners working throughout those systems. The QuIC will encourage other potential Federal participants to do likewise.

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Using Standardized Procedures, Checklists, and the Results of Human Factors Research

Embedding checklists and standardized procedures in medical devices (as has been done with anesthesia gas machines) needs to be expanded to many more medical devices to protect patient safety. The American National Standards Institute (ANSI) is leading an effort to develop U.S. national standards for medical device alarms and human factors-based engineering designs of medical devices. The Association for the Advancement of Medical Instrumentation is developing human factors standards for medical devices. The development of standard operating procedures can also help. For example, the Occupational Safety and Health Administration’s (OSHA’s) Bloodborne Pathogens Standard requiring proper disposal of contaminated sharps and needles ensures a safer environment for both workers and patients. The DHHS Advisory Committee on Blood Safety and Availability has issued recommendations to prevent errors and accidents in the collection and administration of blood.

FDA's Quality Systems Regulation, which governs the design process for medical devices, provides manufacturers with guidance on human factors design principles and information on how to conduct a risk assessment to qualify their design, and serves as a model for other programs. The internationally recognized expertise in human factors research of NASA, DoD, and FAA could be applied to the improvement of patient safety with the establishment of appropriate links to the QuIC participants.

Additionally, recognizing that many problems are not detected until after a product has been marketed, FDA believes that strengthening its premarket activities, including those related to human factors, will aid in reducing problems that users may encounter with medical products in clinical use. For example, premarket testing of standardized procedures for operation and maintenance of products, user instructions, and labels would aid in detecting and preventing errors associated with the use of medical products. FDA proposes to encourage manufacturers to explore human factors issues through the use of premarket focus groups as well as through user testing of the product in its intended environment.

Health care organizations need to develop staff awareness of the need for continuous improvement of quality, processes, and performance as another critical component of error reduction. The Federal health care delivery systems have been providing meaningful quality improvement training to personnel at their delivery sites for several years. Error reduction has been a strong focus for some programs, such as those at VA. For example, quality improvement training led to concentrated potassium chloride containers being removed from patient care settings. This kind of information can be shared broadly with other health care providers to emulate VA’s success.

• CDC and FDA will work with the DHHS Advisory Committee on Blood Safety and Availability to help ensure that the highest quality standards are met in blood collection and transfusion.
• Within 1 year, FDA will begin working with manufacturers of medical products to explore incorporating standards, including human factors standards, into guidance to ensure that medical products are designed to minimize the chance of errors.
• NASA will be invited to become a participant in QuIC activities and bring its understanding and experience in redesigning processes and procedures to enhance safety. Linkages between NASA and the CQuIPS will be established through the NASA Medical Policy Board.
• The QuIC will sponsor an educational program, noted in the section on research above, to increase the awareness of Federal regulators and policymakers regarding patient safety, human factors, and systems-based improvement.
• VA will continue to work with private-sector organizations (e. g., the American Hospital Association and JCAHO) to explore the utility of its comprehensive error analysis and corrective action system.

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