Statement of Michael B. Wood, M.D., President and Chief Executive Officer,
Mayo Foundation, Rochester, Minnesota, and Member, Healthcare Leadership Council

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

Hearing on Legislation to Reduce Medical Errors

September 10, 2002

Madam Chairman, I appreciate this opportunity to speak with you today on a matter of utmost importance to all Americans, the level of safety afforded to each and every patient who enters our health care system. This committee is to be commended for the attention you are giving to this vitally-important issue.

I am President and Chief Executive Officer of the Mayo Foundation, based in Rochester, Minnesota. All of us at Mayo are proud of our institution's worldwide reputation for excellence in clinical practice, education and medical research. We are devoted to innovation and constant improvement B principles that we apply intensely to the area of patient safety.

Today, I am testifying on behalf of my colleagues and counterparts who are members of the Healthcare Leadership Council. The HLC is a coalition of chief executives of the nation's leading health care companies and organizations representing all sectors of health care. We meet on a regular basis to jointly develop policies, plans and programs to achieve our vision of a patient-centered 21st century health care system.

It is important that an organization like the HLC be centrally involved in a national discussion on the best ways to improve patient safety. No single health care sector can act in a vacuum in addressing this issue. Hospitals, medical device manufacturers, health plans, pharmaceutical companies, pharmacies, purchasing companies B all must work in consensus to achieve new advances in patient safety, and to ensure that those advances have widespread implementation.

The HLC is developing this consensus through its Chief Executive Task Force on Patient Safety. Through this task force, leaders from all sectors of health care are working cooperatively to elevate public confidence in patient safety. We are united behind a self-initiated protocol for addressing patient safety positively and responsibly.

Other HLC member companies are involved in increased use of computerized physician order entry, computerized on-floor pharmacies, and scanning barcodes at the patient's bedside to reduce the potential for medication errors. As well, manufacturers are instituting dose-by-dose packaging, improving dosage and interaction instructions, and eliminating look-alike packages and product names.

Many hospitals are voluntarily submitting error data to organizations like the Joint Commission on Accreditation of Health Organizations and U.S. Pharmacopia, where they receive helpful analysis and feedback on how to avoid similar errors in the future. These are just a few of the many examples of activities underway within a health care industry that is committed to error reduction and improved safety.

We are seeing the development of a strong public-private partnership to enhance patient safety. In addition to the innovations and improvements taking place in the public sector, patients will be well served if Congress adopts measures such as the bill you introduced, Madam Chairman, H.R. 4889, the "Patient Safety Improvement Act of 2002." Legislation such as this will provide a valuable assist to health care providers in conducting the kind of information sharing essential to quality improvement. The members of the Healthcare Leadership Council stand ready to work with you to see this approach become law.

In my testimony today, I would like to address three points that are absolutely critical if we are to significantly reduce medical errors and give all patients the confidence that they will receive care that is safe and of the highest quality. First, we must consider the critical role information technology will play in improving patient safety. Second, we need to emphasize the importance of confidentiality and voluntary reporting in the handling of errors, so that we can use the knowledge gained from medical errors to build better, safer health care systems. And, finally, we need to discuss the best methods for developing safe practice standards.

As I mentioned previously, the Mayo Clinic is moving toward a completely paperless environment, including paperless patient records. We have, in fact, completed this process at our Jacksonville, Florida facility. We are doing this because we believe the use of information technology can help ensure the completeness of the patient record, make it more accessible for all health professionals involved in the patient's care, and reduce the possibility of errors. With an electronic record, there is greater assurance that information concerning diagnoses, medication, imminent surgeries and the like is accurate and complete.

There is no question that information technology has enormous potential to help us reduce the possibility of errors, and health care organizations, lawmakers and other policy officials should support the automation of patient safety systems to the greatest extent possible. The Institute of Medicine is urging a new generation of patient safety systems that are automated, information system-based and driven by sound technologies. Certainly, a voluntary health information infrastructure should be encouraged and facilitated as rapidly and as broadly as possible.

There are challenges in this area for which we must develop solutions. Some hospitals, facing budget constraints, are reluctant to purchase these technologies because of concerns that they cannot be integrated with their current IT systems, or because they fear newer, better systems could soon be released which would make their major technology investments obsolete.

The health care industry must work together to develop standards that will encourage widespread usage of information technology systems. HLC is a founding member of the National Association of Health Information Technology. Madam Chairman, you called upon the industry to act proactively in this area, saying that "if you don't, we will." We take that charge very seriously and, with the creation of NAHIT, we intend to work toward standards that will maximize the advantages technology can bring in reducing medical errors. We also intend to work closely with the medical information technology board that H.R. 4889 would create to ensure the development and dissemination of best practices in medical information technology.

Our success in improving patient safety will be largely dependent upon the environment we create for handling medical errors and mining the vitally-important knowledge that can be gained from those occurrences. We must have a culture of awareness, not a culture of blame.

Health care providers must be able to collect and analyze patient safety data, and to use that information to develop better, safer systems. There is a mutual exclusivity between laws that perpetuate litigation and our efforts to transform adverse events and "near mises" into permanent and pervasive system improvements. To put it simply, an increased likelihood of lawsuits will drive this critically-important information underground. The same philosophy applies to the issue of voluntary versus mandatory reporting. We must use positive incentives to encourage hospitals and providers to swiftly report health care delivery problems. Mandatory reporting would be viewed as a punitive effort by the government to extract information from private entities B information that could then be used against them in costly litigation.

Current mandatory reporting programs have been less successful than their supporters envisioned. Compliance with these programs has been inconsistent, due to the punitive nature of the programs and ineffective use of the submitted data. Mandatory reporting requirements, and the increased likelihood of punitive results against health care professionals and organizations, has effectively suppressed error reporting and inhibited open discussion about medical errors.

Existing voluntary reporting systems, on the other hand, have been successful because of their strong focus on improving practitioner performance instead of punitive results. Examples of successful voluntary systems, such as those from the aviation and motor vehicle industries, show dramatic improvements in reporting levels, product design and personnel training. We can learn from these examples that quality improvement requires the design of systems focused on prevention of human error rather than on assigning blame.

Lawmakers must carefully consider any new laws or regulations that could actually do damage to the current health care system by making errors and "near misses" even harder to identify. Confidentiality protections should be instituted to protect organizations from the fear of litigation that would inhibit and prevent the sharing of information. We are pleased, Madam Chairman, to see such peer review protections included in your legislation. With this protection, hospitals will be encouraged to share information with organizations that can analyze it to determine common error patterns and recommend system improvements.

To improve patient safety nationwide, we must create this culture of awareness nationwide as well. Today, some states have strong peer review protections while others do not. These inconsistencies serve as barriers for any patient safety initiatives that involve institutions in multiple states. Moreover, information relating to patient safety and "near-misses" may run the risk of losing peer review protection when shared outside of an institution. This often creates a greater degree of liability exposure than many providers are willing to tolerate.

We would all agree that safe practice standards should be in effect to assure the highest quality of care for all patients, regardless of the physician or institution treating them. We must carefully consider, though, how to develop the most effective standards that will have widespread acceptance and the flexibility to accommodate new innovations in health care.

We believe that nationally-recognized safe practice standards should be developed only through analysis of conclusive data on broad, evidence-based effectiveness and feasibility. And these standards must consider evolving science. Additionally, we must recognize that not all health care institutions or patient populations are exactly alike and, therefore, health care organizations should be encouraged to adopt safe practice programs that are applicable to their unique specialties, patient populations and specific risk points.

Some have expressed the belief that government should develop and enforce universal standards of care. Rigid government regulations in this arena, we believe, would not serve the best interests of patients. Knowledge and innovation in health care is constantly evolving, constantly improving. The practices we freeze in place today with regulatory mandates could well be outdated in mere months.

It is vitally important that practice standards not stifle scientific innovations. If a set of safe practices were to become universally-required standards of care, they could effectively establish a ceiling for patient safety practices, and discourage further innovations for even safer practices. While one might argue that national practice standards could be periodically reviewed and updated, the well-known reality is that our current regulatory process does not accommodate the kind of rapid and substantial changes that new technologies can necessitate. There is also concern that government-enforced standards of care may not be feasible for all hospitals and health providers throughout the nation.

There is a commitment on the part of the health care industry to develop safe practice standards B standards that are meaningful, feasible and that will encourage, not stifle, future improvements. The Healthcare Leadership Council is an active member of the National Quality Forum, and we will continue to work extensively to develop workable standards to achieve the best in patient care.

In closing, I want to again commend this committee for the energy and attention it is focusing on this important issue. Having a hearing like this is conducive to developing the culture of awareness to which I alluded earlier. I am confident that government and the health care industry can work together cooperatively and constructively to create an environment that encourages constant quality improvement. This is an important challenge affecting the lives and safety of every American patient, and it is a challenge that we intend to meet. Once again, thank you for this opportunity to share the views of the Healthcare Leadership Council.