Statement of Lucian L. Leape, M.D., Adjunct Professor of Health Policy,
Harvard School of Public Health, Harvard University, Cambridge, Massachusetts

Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means

Hearing on Legislation to Reduce Medical Errors

September 10, 2002

I wish to lend my strong support for the proposed Amendment to H.R. 4889 offered by Mrs. Johnson, provided it is amended to provide full protection from discovery for voluntarily reported patient safety data.

Progress in patient safety over the past two years has been astounding.  Virtually every national organization and all hospitals are changing their practices to reduce hazards of patient injury.  Many of those efforts have been facilitated by the strong leadership provided by the Agency for Healthcare Research and Quality.  While progress is never as fast as one would wish, injury rates have been reduced, and the pace of improvement is accelerating.

The proposed legislation addresses three important issues related to improving patient safety.  Two of these, Section 1183, establishing a Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ), and Section 1184, developing interoperability standards for health care information technology systems, are broadly supported; the third, protection for reporting, is more controversial.  Let me comment on the easy ones first.

Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ)

As I indicated in my testimony to the Senate Committee on Health, Education, Labor and Pensions last year, the Agency’s role in advancing patient safety has been exemplary.  With generous support from Congress, and under the outstanding leadership of the late John Eisenberg, AHRQ brought together diverse stakeholders to define areas in safety needing further research, disseminate information on known safe practices (such as medication safety), provided help for consumers, and requested and funded research proposals addressing a broad range of safety questions, including such diverse and important topics as the design and evaluation of reporting systems, improvement of medication systems, enhancing collaboration and teamwork, and the effect of working conditions on safe performance.  It commissioned the National Quality Forum to convene a panel that developed a standard list of serious reportable events that states may use in their mandatory reporting systems, and an expert panel that will soon release a list of safety practices.

In a very short time, the Agency has become what the IOM called for, and health care has desperately needed, both a central focus of activity in safety and a demonstration of a national commitment to safety that facilitates work at the local level, in hospitals and health care organizations.  This is government at its best:  not telling doctors and hospitals how to practice, but providing the research, resources and information needed for them to do what they need and want to do, make health care safe for all citizens.  AHRQ is now the major force for improving patient safety, and with continuing support it can become even more useful.   You should be very proud of this.

I strongly recommend that the Center for Patient Safety be given your endorsement through the proposed legislation establishing it as a permanent Center within AHRQ.

The initial funding of $50 million provided by Congress in fiscal year 2001 for the safety effort at AHRQ not only gave a “jump start” to safety research – over 90 projects in six areas – it has had another very important effect:  it has attracted a number of talented researchers and practitioners to work in patient safety.  This is particularly important at this time because this young field of health care safety has only a handful of experts.  Developing that expertise, which is analogous to specialty training in medicine, will take time, but a good beginning has been made.  It is, however, just a start.  The number needed is huge:  providing just one qualified person in each hospital, for example, requires nearly 5000.  If the momentum and commitment are to be sustained, funding for the Center for Patient Safety must be increased substantially each year.

Developing interoperability standards for health care information technology systems

Few technological advances have been so long in coming as the electronic (computerized) patient record.  For over 40 years, the prospect of having all of the patient’s medical information computerized and, thereby, easily accessed and evaluated by those who need to know, has eluded us.  A primary barrier has been the lack of standards for recording and retaining data that permit exchange between a diverse set of computers and data systems.  The time has come to sort this mess out and move ahead with computerization of patients’ medical records.  With proper safeguards, currently available, computerization would enable both patients and their doctors to instantly access information, regardless of where they are.  The benefits in terms of emergency care in far-off places are obvious.  Less dramatic, but much more common usage will be to facilitate exchange of information between specialists and other providers, which has great potential to reduce one of the common cause of errors:  faulty communication.

Not only would a standardized electronic medical record vastly improve the efficiency and safety of patient care, the ability to easily and accurately collect large volumes of clinical data would vastly accelerate the development of evidence needed for the evidence based methods to be disseminated and adopted as wisely specified in Section 1185.  In addition, with appropriate consent and confidentiality safeguards, the universal record could permit large population testing of new drugs within months of their release.  Unsuspected side effects could be detected within months, instead of years at present, saving thousands of lives.

I recommend not only passage of section 1184, and Section 3, establishment of a Medical  Information Technology Advisory Board, but also that Congress provide financial incentives, such as bonuses by CMS, for hospitals that implement computerized patient records.

Protection of voluntarily reported patient safety data

None of the recommendations from the IOM were as controversial as those for reporting of adverse events.  Much of the controversy arose from misunderstandings about the nature of mandatory reporting.  For many years, a number of states have had mandatory reporting systems in which hospitals (not doctors) are required to report particularly serious adverse events (not errors).   The IOM recommended that all states implement such programs, and further recommended standardizing the types of events to be reported in order to facilitate aggregation of data for learning purposes.  AHRQ commissioned the National Quality Forum (NQF) to develop such a list of serious reportable events, which it did and published last year.

The IOM also recommended that voluntary reporting of less serious events be encouraged.   Reporting systems can advance patient safety in several ways.  First, if incidents are promptly reported, it can serve as an “early warning system” to alert all providers of new hazards.  The medication error reporting program (MERP) run by the US Pharmacopoeia (USP) and the Institute for Safe Medication Practices (ISMP) has performed this function for medication errors for years, as does the FDA MedWatch program for adverse drug reactions.  Second, by aggregating large numbers of reports from many institutions, a national reporting system can identify patterns of injury that are not obvious to those at the local level, particularly for rare events or those with unusual causes.  Third, lessons learned by individual hospitals of new methods to prevent errors can be disseminated.  Fourth, analysis can lead to recommendations for “best practices” for all to follow.

It is important to recognize that reporting alone does not improve safety.  Reports must be analyzed and lead to recommendations for changes in care, and those changes must be implemented.  Analysis of reports is an expensive enterprise, requiring a high level of expertise.  It is far more costly than the data entry component of a reporting system, yet those costs have rarely been considered when proposals are made for a national system.  For example, the ASRS run by NASA for aviation receives over 30,000 reports annually and costs approximately $70 per case.  The annual number of preventable injuries in health care is estimated to be over 1 million.  A successful national reporting system for health care conducted at a similar level of expert analysis as ASRS could cost as much as $70 million per year. 

A more feasible option, which in fact is occurring, is the development of system-wide programs, such as that being developed by NASA for the VA, and specialty-based focused reporting programs, such as those developed by neonatal and adult intensivists.  Similar programs could be developed by other health care systems and specialties.

No voluntary reporting system will be successful, however, unless reporting is safe. Fear of discovery with potential adverse legal consequences is a major inhibitor of reporting by hospitals and doctors in all states.  Evidence from many sources, within and outside of medicine, as well as the accumulated experience of several decades, demonstrates that people will not report or discuss information that puts them at risk of adverse personal consequences. If we want this information in order to learn from our mistakes, we must make it safe for people to report.  The proposed legislation wisely provides legal protection for information submitted voluntarily to patient safety improvement systems. This feature is crucial for the success of all voluntary reporting systems, public or private.

Unfortunately, in Section 1182 (d) (2) PERMISSIBLE DISCLOSURES, Disciplinary Proceedings, those protections are removed if the information is needed as part of a disciplinary procedure.  That single clause nullifies all of the benefits of this section.  No thinking doctor, nurse or hospital administrator will provide potentially incriminating information to anyone under these circumstances.  They will not report.  Nor should we expect them to.  If this clause is retained, this legislation will have no impact on reporting.  It will not change the status quo.

Nor is this type of disclosure necessary.  Current regulations already mandate reporting of serious adverse events, including the results of investigations carried out by hospitals, in many states.  Disciplinary proceedings, whether within the hospital or conducted by State Medical Boards, are also governed by detailed and tested rules that assure fair and full exploration of instances of suspected misconduct.  State regulatory bodies have many legitimate methods for obtaining information.  It is only the reports that leave the hospital that need protection.  Much of the information is available in other places. The medical record is available, for example, and while the individual at risk cannot (rightfully, under our Constitution) be forced to testify against himself, other parties have both contractual and legal obligations to provide information.  That is more than sufficient to meet disciplinary needs.

I strongly recommend that the Committee delete section 1182 (d) (2).  If it remains, the so-called “protection” against discovery will be meaningless.