Peer Review Protections

IOM Recommendation

Congress should pass legislation to extend peer review protections to data related to patient safety and quality improvement that are collected and analyzed by health care organizations for internal use or shared with others solely for purposes of improving safety and quality.

QuIC Response

As noted throughout the IOM report, solutions unique to one individual are essentially irrelevant. It is the system-wide, generalizable approach that is the cornerstone to success. The question "Who did it?" is not important. However, it is critical to find out what happened, why it happened, and how it can be prevented in the future.

Basic tenets of a successful reporting system are that those who report must feel safe in doing so and that their confidentiality must be protected. Reporting systems in which these factors are missing are generally unsuccessful in obtaining data, inaccurate, and incomplete. The experience of the aviation industry speaks to the importance of a confidential, blame-free reporting environment. The FAA and others have found major increases in reporting by removing the identity of the institution submitting the report.

On January 14, 2000, President Clinton acknowledged these characteristics of successful safety reporting systems when he announced a program that will provide immunity from punishment to airlines' personnel when they report to the FAA operational and procedural errors that threaten passenger safety. The program's goal, much like that of patient safety systems, is to identify trends early and address them before they cause harm or injury.

The program is committed to providing appropriate protections for data in the system, but the protections will depend on the nature of the data and reporting systems. Such statutory protections already exist in the Medicare program for mandatory reporting to the program's Peer Review Organizations (except when used in criminal investigations). These protections should be extended to protect voluntary reporting to achieve the greatest level of learning. The specific details of the appropriate legal protections must be negotiated with Congress, the industry, and States.

Previous discussion has focused on developing reporting systems for learning that deal with system-wide, rather than individual, performance issues. It is important to understand that individual performance issues are best addressed through credentialing, licensing, and other administrative mechanisms. The QuIC expects that will continue to be the case. However, it is important to note that safety reporting systems should never become a shield from necessary actions to address criminal activity or deliberately unsafe acts. The obligation to report these activities still exists, and mechanisms to address those issues should be maintained. For example, the Health Resources and Services Administration (HRSA)-sponsored National Practitioner Data Bank records disciplinary actions taken against providers. It is maintained, in part, to help institutions carry out their responsibility for patient safety by searching for and reviewing records of applicants who are seeking staff appointments.

• 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.

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Setting Performance Standards and Expectations for Safety

Raising the Standards for Health Care Organizations

IOM Recommendation

Performance standards and expectations for health care organizations should focus greater attention on patient safety.

• Regulators and accreditors should require health care organizations to implement meaningful patient safety programs with defined executive responsibility.
• Public and private purchasers should provide incentives to health care organizations to demonstrate continuous improvement in patient safety.

QuIC Response

Several QuIC member organizations are involved with regulation and accreditation. Some are also health care purchasers. A major purchaser of health care, HCFA, intends to require hospitals in the Medicare program to have an effective internal error reporting system and an effective evidence-based error reduction program for all patients as necessary components for certification and accreditation. The State survey agencies, acting as HCFA's contractors, and the hospital accreditation organizations, will monitor whether activities to reduce medical errors are occurring in Medicare participating hospitals. Enforcement actions will be taken only if such activities are not occurring. HCFA will conduct research and pilot studies or demonstrations in nursing homes, where experience with error measurement is more limited but the need may be equally great.

The current Conditions of Participation (CoP) for hospitals participating in Medicare require that the hospitals meet State laws, which includes error reduction systems. Thus, Medicare rules support existing State requirements for confidential reporting, whether voluntary or mandatory.

The Health Care Financing Administration will publish regulations this year requiring the over 6,000 hospitals participating in the Medicare program to have ongoing medical error reduction programs that would include, among other interventions, mechanisms to reduce medication errors. In order to comply with this new regulation, hospitals may choose to implement automated pharmacy order entry systems, include automatic safeguards against harmful drug interactions and other adverse side effects built into the treatment process, or institute decision-support systems.

Purchasers, both public and private, have leverage to stress the importance of a safe environment in which to deliver patient care. This leverage must put a premium on medical error reduction through identification, systems approaches to resolution, and assessment of overall effectiveness. Both through its own purchasing power and by working closely with private purchasers, HCFA will institute financial and burden-reduction incentives to move providers to create a safer health care environment. In addition, HCFA, as a purchaser, will work with and support accreditation organizations' efforts to set standards for patient safety, to measure and report results, and to use these standards in their purchasing decisions. The Office of Personnel Management (OPM) will require that all plans with which it contracts be accredited by organizations that include evaluation of patient safety programs in their accreditation process.

• 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.

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Raising the Standards for Health Care Professionals

IOM Recommendation

Performance standards and expectations for health professionals should focus greater attention on patient safety.

• Health professional licensing bodies should:
—Implement periodic re-examination and relicensing of doctors, nurses, and other key providers, based on both competence and knowledge of safety practices.
—Work with certifying and credentialing organizations to develop more effective methods to identify unsafe providers and take action.
• Professional societies should make visible commitment to patient safety by establishing a permanent committee dedicated to safety improvement. This committee should:
—Develop a curriculum on patient safety and encourage its adoption into training and certification requirements
—Disseminate on a regular basis information on patient safety to members through special sessions at annual conferences, journal articles and editorials, newsletters, publications, and Web sites.

QuIC Response

The QuIC proposes that the Federal Government take a lead role in fostering patient safety efforts through a concerted program in support of error reduction and improved safety. HRSA, HCFA, VA, DoD, OPM, and all other Federal agencies that provide or sponsor health services will collaborate in a five-part program to foster a reduction of medical errors and to promote health care quality This program will include:

1. Programs that directly impact health care quality in the community: HRSA, HCFA, OPM, and VA, with other appropriate agencies will foster community and professional programs that increase quality of health care (such as DQIP, the recently developed Diabetes Quality Improvement Project) and decrease errors (for example, pharmacy prescription surveillance programs). HRSA will use the Area Health Education Center (AHEC) Program and other programs that affect continuing professional education in the community to increase such error reduction and quality promotion programs.
2. Quality Infrastructure Development: Agencies such as DoD and VA, together with other agencies as appropriate, will develop studies and tools for error detection and reduction. These tools will reflect both internal experience as well as other scientific and evidence-based information.
3. Health Professionals Education and Training: HRSA, HCFA, and other Government agencies will foster development of courses and training materials that promote error reduction and patient safety by providing incentives through grants and contracts for the development of new curricula in health care quality and error reduction methodologies. These will explore clinical training programs that could incorporate the simulation models tested by VA, DoD, and others to reduce error in clinical training programs and the use of CDC's Epidemic Intelligence Services (EIS) as a model.
4. Licensing and Certification: The QuIC will convene a meeting of accrediting, licensing, and certifying bodies to propose, investigate, and evaluate educational methods to improve analysis, understanding, and prevention of medical errors. This will also include collaboration with the Federation of State Medical Boards and others to encourage education in these areas as a component of relicensing. HRSA, in coordination with State governments and other agencies involved with licensing and certification bodies, will assist licensing bodies to assure continuing competence among practitioners and to take appropriate actions to protect against unsafe providers. This will include provision for error-prevention education as part of the relicensure process.
5. Technical Assistance: The QuIC will provide technical assistance to State or professional agencies seeking to ensure a basic level of knowledge for health care providers on patient safety issues, promote model patient safety programs that include evidence based best patient safety practices to provider organizations, or help agencies implement the cultural change necessary to make reporting systems a success.

Priority components of such a four-part program include community quality measures, infrastructure development, health professional training, and licensing and certification measures. These programs will be carried out cooperatively by involved public- and private-sector institutions.

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.

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Safe Use of Drugs and Devices

IOM Recommendation

The Food and Drug Administration (FDA) should increase attention to the safe use of drugs in both pre- and postmarketing processes through the following actions:

• Develop and enforce standards for the design of drug packaging and labeling that will maximize safe use.
• Require pharmaceutical companies to test (using FDA-approved methods) proposed drug names to identify and remedy potential sound-alike and look-alike confusion with existing drug names.
• Work with physicians, pharmacists, consumers, and others to establish appropriate responses to problems identified through postmarketing surveillance, especially for concerns that are perceived to require immediate response to protect the safety of patients.

QuIC Response

The FDA works to ensure the safety and effectiveness of medical products, including drugs, medical devices, and biological products such as human blood. In May 1999 the FDA published a report, Managing the Risks from Medical Product Use, that evaluated its role in medical safety and discussed options for further improvements. The report emphasized the systems nature of medical safety and the role of the many stakeholders in the safety chain.

FDA is responsible, in conjunction with Institutional Review Boards, for oversight of patient and volunteer safety in clinical trials of investigational medical products. To this end, FDA reviews clinical protocols conducted under Investigational New Drug Applications and Investigational Device Applications, monitors the adverse events occurring in trials—reporting adverse events is mandatory for investigators and trial sponsors—and requires modification or cessation of trials when patient safety is an issue.

FDA has promulgated extensive safety criteria that medical products must meet prior to marketing. Drug, devices, and biological products must undergo laboratory and clinical testing and meet safety standards before approval. In addition to toxicological and human safety testing, these criteria include design controls and human factors testing for medical devices, and requirements for naming, packaging, and labeling pharmaceuticals. Strengthening criteria aimed at reducing name confusion, dosage errors, and device misuse, or improving comprehension of the product information, would reduce product-related errors. Improving product safety requirements will require additional research and collaboration with health care delivery systems, health care professionals, Government agencies, and manufacturers. Additional work could be done to implement human factors testing in the evaluation of medical devices, and to institute such testing for pharmaceuticals.

Threats to patient safety from medical products can arise from unsafe products or from unsafe use of medical products. Despite extensive premarket safety evaluation, unanticipated errors do occur as medical products are used in the health care system. Although FDA is extensively involved in the detection and prevention of such errors, many more steps can be taken to increase the safe use of these products. For example, FDA has completed Phase I of implementing the Congressionally mandated Medical Product Surveillance Network (MedSuN), an active reporting network. FDA now wants to implement a large-scale Phase II study that will allow the dissemination of data regarding emerging device problems to health care professionals and the public.

Although FDA engages in numerous outreach efforts, more safety information, in a more useful form, needs to be provided to users of medical products. Similar opportunities for increased efforts exist in the areas of risk detection, data analysis, risk management, and risk communication. The FDA, as outlined in the action items below, will take steps to increase its capacity to detect errors, investigate and understand them, and prevent further occurrences. The knowledge gained in these investigations can also be incorporated into premarket review activities, thus preventing repetition of errors with new medical products.

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.

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Implementing Safety Systems in Health Care Organizations

IOM Recommendations

Health care organizations and the professionals affiliated with them should make continual improvement in patient safety a declared and serious aim by establishing patient safety programs with defined executive responsibility. Patient safety programs should:

• Provide strong, clear, and visible attention to safety.
• Implement nonpunitive systems for reporting and analyzing errors within their organizations.
• Incorporate well-understood safety principles, such as standardization and simplification of equipment, supplies, and processes.
• Establish interdisciplinary team-training programs for providers that incorporate proven methods of team training, such as simulation.

Health care institutions should implement proven medication safety practices.

QuIC Response

Extensive "hands-on" communication is critical in building trust in the population from whom reports are expected. Systems perceived as punitive or exposing individuals or institutions to legal liability have proven to be much less effective than desired. For example, JCAHO has experienced significant difficulty in securing hospitals' participation in its "sentinel events" reporting system because of worries surrounding legal vulnerabilities or punitive actions.

Another factor influencing the success of safety programs is the level at which organizational responsibility is established. Experts suggest that safety programs within individual organizations or institutions are most effective when reporting is at the level of the chief executive officer. Responsibility and reporting at the level of the CEO makes the issue of organizational accountability clear. It ensures that patient safety has the attention of the highest levels of the organization. It sends a clear message throughout the organization that safety is a priority, and it helps remove the inherent conflicts of interest that may occur if the reporting occurs at lower levels.

Several Federal agencies have already undertaken the task of creating meaningful patient safety systems within their health care delivery organizations. VA has an exemplary patient safety program, and the DoD is developing one that is modeled after that of VA. The National Institutes of Health's Clinical Center has a long standing "Occurrence Reporting System" to report unanticipated patient care events. Further refinements of each system will be made.

This summer, the QuIC will be working with the Institute for Healthcare Improvement (IHI) to create an initiative that will test several strategies for rapidly reducing the number of errors committed. Our effort will be targeted specifically at health care delivery settings where patients are in need of urgent assistance and decisions have to be made rapidly, which we are calling "high-hazard environments." These would include emergency departments, operating rooms, intensive care units, and on-site rescue operations. This is the first such initiative targeted at error reduction in these high hazard environments. Based on the results of previous IHI initiatives, it is hoped that some sites will be able to achieve reductions of 25–30 percent in the number of errors within 12 to 15 months. The findings from this Federal effort will be shared broadly to help other organizations reduce errors in their own health care delivery settings.

Information technology offers other opportunities for the reduction of medical errors and is discussed in Chapter 3.

• 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 (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.

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Framework for Reporting Systems

A. Purpose: Data collected for one purpose are not easily used for another.

B. Reporting: Need clear definitions, easy mechanisms for reporting, system capable of using data for intended purpose (1).

• Learning
• Mandatory
• Need incentive (e.g., return of valuable information) to ensure reporting.
• Data need to be protected from discovery.
• Could include near misses likely to lead to major adverse event.
• Voluntary
• Reporter must see it in self-interest to report.
• Completeness of database contingent upon willingness to report.
• Could include near misses likely to lead to major adverse event.
• Accountability
• Mandatory
• Accountability aspect could be the review (i.e., audit) of the safety and error analysis process.
• Many systems already exist for high interest/high profile adverse events.
• Works best for events that are difficult to overlook.
• Voluntary
• Not applicable because no one would agree that something truly voluntary is a basis for accountability.

(1) Any criminal act identified through reporting systems will be handled with appropriate mechanisms.

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