National Focus and Leadership

Center for Patient Safety

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

Research Planning

• Hold national summits on medical error and patient safety research: AHRQ will lead the convening of conferences and expert meetings to review the information needs of those who wish to improve safety, assess the current state of patient safety research, set coordinated research agendas, and develop adequate reporting mechanisms. VA will lead a summit on lessons learned from its experiences in improving patient safety, and the FDA will lead a summit on drug errors. These summits will take place within 1 year.
• Establish joint research solicitations (including partnerships between AHRQ, CDC, FDA, and VA) for:

—Fundamental Research on Errors: Investigate root causes analysis, informatics, the role(s) of human factors, and legal/judicial issues.
—Research on Reporting Systems: Identify critical components of successful reporting systems used for learning, examine options for voluntary and mandatory reporting systems, implement and evaluate demonstration programs for reporting, evaluate existing State mandatory reporting systems, and investigate techniques and methods for analyzing and disseminating patient safety data (including integration into a National Quality Report being prepared by DHHS under the leadership of AHRQ and CDC).
—Applied Research on Patient Safety: Test the application of human factors knowledge to the design of health care products, processes, and systems; identify best practices in reducing errors; fund patient safety "Centers of Research Excellence"; and support research and demonstrations on-site, as well as level-of-care and cross-cutting research, such as in diagnostic accuracy, informatics applications, and systems re-engineering.
• Develop tools for the public and private sector to support efforts to enhance patient safety, including:
—Applications: Identify tools and approaches from other industries that could be applied to the health care sector and develop community-based settings that can serve as laboratories for error reduction through medical specialty societies, primary care networks, and integrated service delivery networks.
—Measures: Develop and evaluate data specifications for reporting on patient safety and work with the Quality Forum and other private- and public-sector efforts on developing consensus around a core set of measures for patient safety.

• Finalize a QuIC Research Agenda on Working Conditions and Patient Safety. The QuIC will finalize a research agenda to explore the relationship between health care workers’ working conditions and the quality of patient care, including patient safety. CDC and AHRQ will coordinate this activity with VA and other agencies.

Return to Contents

Identifying and Learning From Errors

Accountability

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

Learning from Errors

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

Peer Review Protections

• The QuIC supports the extension of peer review protections to facilitate reporting of errors in a blame-free environment, and will propose considerations of confidentiality that will not undermine current mechanisms to address criminal activity or negligence.
• As part the development of the national reporting system, appropriate electronic protections (i.e., firewalls and encryption) will be constructed to ensure that the confidentiality of the patients involved and the clinician or institution providing the information is maintained, and that the information gathered will not be used for punitive purposes. Experience with reporting systems in other industries demonstrates that this approach encourages reporting of errors.

Return to Contents

Setting Performance Standards and Expectations for Safety

Raising the Standards for Health Care Organizations

• HCFA will use its power as a purchaser and regulator to promote the use of effective error-reduction initiatives in the health care institutions with which it deals.
• HCFA will publish regulations this year requiring hospitals participating in the Medicare Program to ongoing medical error reduction programs.
• OPM will follow the lead of selected private purchasers to raise the standard for participation by requiring that all health plans with which it contracts seek accreditation from an independent, national accrediting organization that includes evaluation of patient safety and programs to reduce errors in health care.
• In its call letter for the 2001 contract year, OPM will ask health plans to encourage their preferred hospitals to use automated prescription systems and other integrated data systems. OPM will encourage health plans to annotate PPO directories to indicate which hospitals and physicians’ offices use such automated programs.

Raising the Standards for Health Care Professionals

The QuIC will:

• Develop and evaluate programs introducing health professionals to errors analysis and the challenges of practicing in a technically complex environment, explore the use and testing of simulators and automation as education tools, support training in errors research and evaluation, and develop patient safety expertise at the State level using the CDC’s Epidemic Intelligence Service as a model.
• Convene a meeting of the accrediting, licensing, and certifying bodies of the health professions to review information on medical errors in the context of current practice requirements and propose methods of strengthening health professions’ education in the areas of medical error prevention and medical error evaluation as a means of improving patient safety.
• Collaborate with the Federation of State Medical Boards and other entities to encourage that error reduction and prevention education be a provision for relicensing of health professionals.
• Collaborate in the planning, implementation, and evaluation of a national summit addressing patient safety and medical error reduction programs, and in producing directives for the future.
• Provide training within the QuIC agencies that provide care to encourage use of patient safety information and encourage enhanced reporting in partnership with private-sector accreditors, purchasers, and providers.
• Provide technical assistance to State or professional agencies seeking to ensure a basic level of knowledge for health care providers on patient safety issues.

Safe Use of Drugs and Devices

Within 1 year, the FDA will initiate programs to:

• Develop additional standards for proprietary drug names to avoid name confusion.
• Develop standards for packaging to prevent dosing and drug mix-ups.
• Develop new label standards for drugs, highlight drug–drug interactions, potential dosing errors, and address other common errors related to medications.
• Implement the Phase II pilot study of the Congressionally mandated Medical Product Surveillance Network (MedSUN).
• Intensify efforts to ensure manufacturers’ compliance with FDA programs, specifically naming, labeling, and packaging.
• Provide access to databases linked to health care systems and other sources of adverse-event and marketing data, and link these to existing registries of product users.
• Complete the on-line Adverse Event Reporting Systems (AERS) for drugs and biologics.
• Strengthen FDA's analytical and investigative capacities.
• Strengthen FDA outreach activities and collaboration with other Government agencies and stakeholders.

Return to Contents

Implementing Safety Systems in Health Care Organizations

• Under the leadership of the CQuIPS, the QuIC will promote, at the executive level, the development and dissemination of evidence-based, best patient-safety practices to provider organizations.
• QuIC participants, including HCFA, VA, DoD, AHRQ, CDC, and FDA, will explore opportunities with private-sector accreditation, purchaser, and provider organizations to develop organization-based, patient-safety models that could be evaluated, and if found effective, disseminated widely. In addition, these stakeholders will be engaged in a regular dialogue with QuIC participants to ensure that the stakeholders’organizational needs are being met through Federal research and reporting initiatives.
• Through its exemplary patient safety program, VA will continue to scrutinize its care provision for opportunities to improve safety, and develop and expand its reporting system.
• VA will invest $47.6 million this year to increase patient safety training for staff (select for details in Chapter 3).
• DoD will invest $64 million in FY 2001 to begin implementation of a new computerized medical record system, including an automated order entry system for pharmaceuticals (details in Chapter 3).
• Other QuIC direct-care providers will initiate patient safety programs (e.g., HRSA’s community health care centers are investigating the most effective programs that can be implemented in their health care delivery systems).
• QuIC member agencies will begin a collaborative project this summer with the Institute for Healthcare Improvement to reduce errors in high-hazard health care delivery settings.

Building Public Awareness of Medical Errors

• 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.

Building Purchasers’ Awareness of the Problem

• 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.

Working with Providers to Improve 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.

Using Decision-support Systems and Information Technologies

• 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.

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

• 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.

Return to Contents

Standards

• The QuIC and its member agencies will ask independent accrediting organizations to demonstrate how they are coordinating and strengthening their patient safety standards.
• AHRQ’s CQuIPS, through the research agenda articulated above, will develop evidence-based measures that integrate human factors and lessons from other industries.
• As with the DQIP measurement set, the QuIC will solicit formal adoption and use by member agencies of common, validated, and standardized performance measures in the area of error reduction. The QuIC will work with certifying boards for healthcare professionals to incorporate these measures into certification and recertification programs where appropriate.
• QuIC agencies will encourage their private-sector partner organizations to support the implementation of more rigorous safety standards and will act to facilitate the ability of private-sector partners to do so.
• The QuIC will work through the Quality Forum, the NPSF, and the NPSP to collaborate with private-sector organizations, industry representatives, academic institutions, and scientific and health care professionals to examine issues related to standards, to test standards of performance measurement, and to establish a set of core standards.
• DOL will build on an existing collaboration with the National Association of Insurance Commissioners (NAIC) to exchange information between DOL, the States, employers, plans, and individual patients on medical errors and safe, high-quality health care.
• OPM will participate with private-sector organizations in the development of standards and measures, will share QuIC-adopted standards and measures with its health plans, and advocate the use of such standards and measures throughout plan networks.
• OPM will also begin collecting performance measurement data from its participating plans, and will make performance information available to beneficiaries of the Federal Employees Health Benefits Program.
• Patient safety and reducing medical errors will be a featured topic at OPM’s Fall 2000 annual health plan conference.

Return to Contents

Data Integration

• The QuIC members will work with and support the Quality Forum in its identification of a core set of errors reporting data.
• AHRQ, working with its QuIC partners, will identify existing data sets (such as the State mandatory errors reporting data) that can be brought together to enhance the Nation’s knowledge and understanding of errors. Based upon experience with the HCUP and the CDC’s data integration efforts, AHRQ will work with those entities that have the data, to determine the feasibility of pooling the data and using this resource to learn about opportunities to reduce errors and enhance patient safety.
• OPM will discuss with health plans and preferred provider organizations the development of strategies for focusing disease management programs and integrated data systems on the goal of avoiding medical errors and improving patient outcomes.
• HCFA, in collaboration with FDA and AHRQ, will develop a strategy for incorporating initiatives to increase patient safety into the pharmacy benefit managers program under an expanded Medicare drug benefit.

Return to Contents