Statement of Kenneth T. Segel, Director, Pittsburgh Regional Healthcare Initiative, Pittsburgh, Pennsylvania

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

Hearing on Legislation to Reduce Medical Errors

September 10, 2002

Chairman Johnson, Congressman Stark and Members of the Subcommittee:

Thank you for your invitation to comment on H.R. 4889, the Patient Safety Improvement Act of 2002.  It was an honor for Karen Wolk Feinstein, Ph.D., Chair of PRHI to testify before you on patient safety issues this spring, and we are honored to be asked to provide you with our perspective again today.  Given the depth and sensitivity with which you have examined these issues, the importance of the legislation you have compiled is not a surprise.

As brief background to my comments, I want to provide an update on the patient safety activities of the Pittsburgh Regional Healthcare Initiative (PRHI).

PRHI is a collaborative effort among all of the region’s major stakeholders in health care, including clinicians, hospitals, insurance plans, corporations and small-business purchasing alliances, labor, and even the Attorney General of Pennsylvania.  Our goal is to establish the world benchmark for patient outcomes in Southwestern Pennsylvania, by identifying and solving problems “at the point where patients are cared for.”  We have five major clinical improvement projects, and two major patient safety projects.   We take much of the inspiration for our efforts from Pittsburgh-based Alcoa, which under now-Treasury Secretary Paul O’Neill, became the world’s safest organization.

PRHI now includes 42 hospitals working collaboratively to eliminate medication errors and nosocomial (healthcare acquired) infections.  As part of that effort, participating hospitals are all using the same medication error (US Pharmacopeia’s MedMARx) and nosocomial infection reporting systems (the Centers for Disease Control’s NNIS).  In this work, we have received invaluable assistance from critical federal partners, including the Centers for Disease Control, the Agency for Healthcare Research and Quality, and the Center for Medicare and Medicaid Services.

We have seen encouraging but early signs of progress, including drops in our first targeted type of infection – catheter associated blood stream infections in intensive care units -- which have fallen by 28% in one year.  We have also seen sharp increases in the number of medication errors reported.  While Pittsburgh area hospitals constitute roughly 5% of the hospitals using MedMARx nationally, they contribute roughly 10% of the medication error reports.  Of course this is encouraging news, because the vast majority of medication errors are unreported, and only by reporting can they be learned from and other errors prevented.  Through our additional collaborative efforts to improve clinical outcomes for patients, we have seen a 14% drop in mortality following cardiac bypass operations in one year (between 1999 and 2000), and are the only region in Pennsylvania with a lower death rate than could be expected given the risk-level of our cardiac patients.  40 more cardiac bypass patients are alive today because of the work of our cardiac surgery community.

So, we are acting to address the concerns identified by the Institute of Medicine and our own community. 

Despite progress, however, our efforts continue to be slowed dramatically by the cautiousness of most hospitals and clinicians to share information about errors openly due to fear of suit for even the discussion and analysis of errors.  This introduces tortuous procedures and cautions into the process of error reporting, analysis, sharing of learning, and improvement as a result. 

In that context, we believe H.R. 4889 would promote the more open, honest, and effective reporting, and analysis of errors that medicine desperately requires.  You have modeled your efforts on other high-risk industries such as aviation and nuclear power where such approaches have proven to save lives.  We hope your colleagues in Congress recognize the urgency of echoing these models in health care, where lives are being lost every day for lack of such a protected reporting and analysis structure.

To be most useful to you, I want to comment on a few critical aspects of the bill as presently structured, and suggest modifications that might strengthen it.  As our experience “on the ground” has taught us, the devil is in the details of how the critical provisions of this legislation would be interpreted in the courts and by the healthcare legal community.

Patient Safety Data Covered (section 1181(e)(1)(a) and 1181(e)(1)(c))

1) We were very encouraged to see that your legislation does not limit protection to patient safety data collected “solely” for the purposes of reporting to a patient safety organization, such as other federal legislation has proposed.  This is essential to reflect the “real world” of healthcare delivery and hospital processes.    The inclusion of the word “solely” or an equivalent restriction would impose the creation of parallel processes of error identification, analysis and corrective action on institutions.  They would be left with the present faulty patchwork of peer review law to “protect” any internal error reporting and patient safety improvements that were not initiated “solely” in relation to a patient safety organization.  This would lead to less than enthusiastic and complete use of the patient safety organization reporting process.  We urge you to stand firm for your “common sense” approach to this critical definition. 

2) In this regard, we strongly recommend that you make explicit that the bill’s protections would apply to corrective actions taken by a provider internally in response to patient safety data, even before waiting for feedback from a patient safety organization.  Again, this reflects operating reality.   The goal is to have errors surfaced and resolved as close to “real time” as possible.  If providers are forced to wait for external direction and feedback from a PSO before taking any action on data they report in order to enjoy any legal protection regarding the corrective action having been taken, we would undermine the likely scale and impact of corrective steps.

This clarification is especially important given the requirements for independence of the PSOs. 

Definition of Health Care Provider (1181(d))

3) We recommend that you expand the definition of covered entities to include health insurers.   Because of their comprehensive data sets, insurers often have rich information about errors and error prevention efforts that should be available for learning under the protections of this act.  Absent explicit inclusion of insurers as entities that can report and derive protection under the legislation, this source of knowledge will go untapped by the nation.

Interoperability of Health Care Information Technology Systems (1184)

4) We want to applaud this component of the legislation and urge you to take all steps within your power to see that such interoperability standards are established.  The gains to quality and safety of health care, and efficiency of the healthcare delivery system would be truly enormous.

Voluntary or Mandatory Reporting

We understand that one of the issues under discussion is whether reporting by healthcare organizations under the proposed Act should be voluntary or mandatory.  This is a challenging public policy question – one that will be played out in Pennsylvania over the next several years due to the passage of legislation requiring reporting of safety incidents within 24 hours of confirmation.  But let us suggest that there should be years of trust-building with the healthcare community in a voluntary error-reporting system before Congress consider mandatory reporting provisions.  If Congress proceeds with a mandatory requirement right away, it will frame the issue in the traditional mode of regulatory compliance played between regulators and providers, and within healthcare institutions will leave implementation firmly in the hands of the conservative, cautious lawyers that so influence hospital practice in these areas.  An opportunity to redefine how we approach issues of healthcare performance will have been lost.

In that mode, we would encourage Congress to think boldly in terms of “carrots” instead of just sticks to encourage future reporting. 

In conclusion, we applaud your leadership and sensitivity in moving this essential legislation.  We believe that if its essential protections can be enacted into law, it can make a profound impact on the safety, quality and value of healthcare services in our community, and the United States.