American Association of Health Plans (AAHP)

Additional Statement, Submitted by Charles M. Cutler, M.D., Chief Medical Officer; Carmella A. Bocchino, MBA RN, Vice President, Medical Affairs

The American Association of Health Plans (AAHP) appreciates the opportunity to provide a written statement on the important topic of the medical errors research for the National Summit on Medical Errors and Patient Safety Research sponsored by the Quality Interagency Coordination Taskforce (QuIC). AAHP represents more than 1,000 HMOs, PPOs, and similar network plans providing coverage to more than 150 million Americans. AAHP member plans are dedicated to a philosophy of care that puts patients first by providing coordinated, comprehensive health care.

Patient safety and medical errors are important issues that must be addressed in a thoughtful, but active and aggressive manner if we are to improve the quality of health care in the United States. The Institute of Medicine (IOM) report has performed an important service by raising the public's awareness about the long-standing problem of medical errors and we applaud the Institute's goal to improve patient safety. We also recognize the efforts of the QuIC Taskforce to bring the issue of medical errors research to the forefront, and we support the Taskforce as it moves forward to implement the federal agency recommendations highlighted in its response to the IOM report.

AAHP feels that research targeted to improving patient safety and reducing medical errors is critically important in improving health care in the United States. In our written statement, the following areas will be addressed:

• The ability to identify errors and other risks to patient safety is crucial to diagnosing and treating the root causes of medical errors. To do this, we need to create an environment supportive of patient safety that diminishes the "culture of blame" and encourages and fosters reporting by incorporating certain elements into error reporting systems;
• The current status of research relevant to medical errors and patient safety; and
• Research opportunities in the outpatient setting that include roles for physicians and other health care professionals, health plans, pharmacy organizations and governmental agencies.

Identifying Medical Errors

Creating an Environment supportive of patient safety. We wholeheartedly support research that aims to improve patient safety and reduce medical errors. The first step in this research agenda is to identify the problem. Only then will we be able to adequately assess the impact of errors in healthcare and implement systems to prevent these events from recurring. In order to accomplish these goals, we need to create an environment supportive of patient safety and reporting errors, misadventures, and potential threats to patient safety.

Mandating reporting in a vacuum will not lead to better outcomes. To quote from Human Error in Medicine, " It is imperative that an atmosphere be created in which medical care personnel can freely provide data about errors and near errors they experience." (Bogner, Human Error in Medicine, 1994) As an example of how a supportive environment can promote effective reporting, the federal Aviation Safety Reporting System has established incentives and safe harbors that contribute to the reporting of almost 20,000 errors each year. Aviation officials point to a system that is viewed by workers as confidential and non-punitive. What we can learn from the experiences in the aviation industry is that there are many factors that will impact the success of measures to improve patient safety and these elements must be considered in order to develop an effective research agenda.

Accordingly, AAHP believes that the following elements must be embraced if we are to encourage health care providers to report medical errors, and move away from a "culture of blame" and put our health care system on a path toward improving patient safety.

• Error reporting must be tied to significant malpractice reforms. Fear of litigation has interfered with efforts to identify medical errors. The culture of blame pervades every aspect of medicine, from affecting patient safety to increasing medical costs by encouraging the practice of "defensive medicine." In order to promote a more positive environment for reporting and identifying medical errors, we need to enact malpractice reforms applicable to health care claims.
• Reported information is strictly confidential. While the IOM report supports confidentiality for errors not defined as "serious adverse events," we feel there must be strong confidentiality protections for both mandatory and voluntary error-reporting systems, in part so that reports themselves cannot be used as a basis for initiating or pursuing liability claims. It is critical to recognize that failing to adopt a policy of strict confidentiality for error reports simply means that errors will not be reported, and therefore will go uncorrected, leading to more unnecessary patient injuries. Precedent for maintaining the confidentiality of reported errors already exists in state peer review laws and regulations.
• Analyzed data is reported in aggregate. While researchers will need access to the identity of the individuals and institutions that have committed an error for the purpose of analyzing the data, public reports should not use any individually or institutionally identifiable information.
• Data is reported to a national entity. The IOM recommends that data be collected on a state-by-state basis. However, this would complicate the ability to easily access data and to identify system-wide trends. A national system, based on uniform data collection, is needed to identify the underlying systemic causes of medical errors.
• Data is used and not warehoused. Error reports are useless if they are not analyzed and if the resulting information is not fed back to those providing for and delivering health care. The entity that receives error reports should have the capability to analyze them and to make the reports available to bona fide research organizations for analysis.

The above elements are embodied in AAHP's Statement of Principles on Patient Safety adopted by AAHP's Board of Directors earlier this year. AAHP also supports the general principles for patient safety reporting systems that were developed by a coalition of healthcare organizations and professionals convened by the United States Pharmacopeia (USP). These principles which address the following five areas cover many of the same areas as AAHP's Statement of Principles:

1. Creating an environment for safety;
2. Data analysis - information submitted to reporting systems must be comprehensively analyzed;
3. Confidentiality - protections for patients, healthcare professionals and healthcare organizations are essential;
4. Information sharing - reporting systems should facilitate the sharing of patient safety information; and
5. Legal status of reporting information - information developed in connection with reporting systems should be privileged for purposes of federal and state judicial proceedings in civil matters and for the purposes of federal and state administrative proceedings.

Only under a new environment including malpractice reforms and strict confidentiality does AAHP believe mandatory reporting for serious adverse events attributable to medical error is an appropriate and effective way in which to conduct research related to the reduction of medical errors in the healthcare system. Such reporting must be tied to incentives to change current behavior of under-reporting errors, if we are to make headway in promoting patient safety. In the absence of these changes our efforts to begin to address the problem of medical mistakes will be hindered.

Other Issues Raised. In order to appropriately identify medical errors that may be used as a framework for applied research, there are a host of other issues that must be addressed related to the error reporting. To list a few:

• What type of errors will be reported and what criteria will be used to categorize these errors? Not all errors are of such gravity to require mandatory reporting. Clearly defined criteria must be developed that will identify and distinguish between egregious errors that will be reported on a mandatory basis, versus errors that are less serious and will be reported voluntarily. Effective and timely communication of these definitions to the entire healthcare industry is essential.
• Who will be able to report errors? Will patients or their family members, in addition to medical professionals, be viewed as a source of error reporting? Additionally, will the process of self-reporting work by itself?
• What other types of information would be included in an error report? There will need to be clear parameters on what type of information is necessary to track medical errors. Even with confidentiality provisions in place, the error reports will be based on material that may be extremely sensitive to all involved parties. To determine what information is presented in the error report, the question of what error data will be needed to perform an initial evaluation and subsequent root cause analyses must be answered.
• Who will have access to the data and how will it be used? There will be broad interest in obtaining the data, and it is critical to ensure that the data is only used for the purposes of improving patient safety. Provisions relating to data security and confidentiality procedures will have to be put into place.
• What is the most efficient way to collect data on errors? A concise algorithm that details the elements of the reporting system (e.g. types of errors reported, the criteria used to categorize these errors, who will report errors, and who will have access to the data) may be an effective method to provide a framework for data collection that could be easily communicated to the health care industry.
• What are the key barriers to reporting and how can they be removed or minimized? In order to produce accurate and complete data to support research into medical errors, key barriers to reporting must be identified and addressed. More initiatives focused on the effectiveness of the methods used to discourage non-reporting such as providing incentives to practitioners are needed.

"Culture of Blame". A major area of research and inquiry is related to the creation of an environment supportive of patient safety. Why have we not been able to effectively improve patient safety when we have evidence of the proliferation of medical errors, based on the findings of the IOM report?

In order to answer this question, we need to examine the atmosphere in which physicians, hospitals and other health care providers function. Most medical errors result from a series of often subtle events in the systems that deliver care, and not from the negligence of individual practitioners or institutions. Obviously, a "culture of blame" is not conducive to the identification and reporting of errors-the essential precondition for understanding why an error has occurred and what changes are necessary to avoid its repetition. This was noted by both the IOM and President Clinton's Advisory Commission on Consumer Protection and Quality in the Health Care Industry in 1998.

• Patient safety is "hindered through the liability system and the threat of malpractice, which discourages the disclosure of errors. The discoverability of data under legal proceedings encourages silence about errors committed or observed. Most errors and safety issues go undetected and unreported, both externally and within health care organizations." To Err is Human, Institute of Medicine, 1999
• "[P]erhaps the most significant deterrent to the identification of errors is the threat of costly, adversarial malpractice litigation." President Clinton's Advisory Commission on Consumer Protection and Quality in the Health Care Industry, Final Report, 1998

Direct evidence of the impact of litigation on patient safety is not hard to find. In considering Joint Commission on Accreditation of Healthcare Organizations (JCAHO) policy to require reporting of all "sentinel events" that occur in hospitals (defined as all unexpected occurrences that resulted or could have resulted in a patient's death or serious injury), the American Medical Association (AMA) House of Delegates determined it could not support the requirement due to the fear of lawsuits such reporting would generate. Clearly then, we need to replace the "culture of blame" that inhibits the identification of medical errors, and in doing so, perpetuates them. In its place, we need to create an environment that encourages the reporting of errors and enables all participants in the health care delivery system to learn from mistakes in an effort to prevent them from recurring.

Proceed to Next Section
Top of Page