Evaluation of errors and provision of patient care without fear of retribution are essential if the subject of patient safety is to be adequately addressed. There must be a climate that encourages practitioners to self-disclose errors free from fear of litigation and personal repercussions and that supports frank and honest discussions about care of patients when it goes wrong. There are numerous issues related to why providers are reluctant to publically report data required by the Centers for Medicare & Medicaid Services (CMS), The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and other regulatory and accrediting bodies. These issues include errors, blame, ethics, and economic pressures, to name a few. There is a very real risk that public data reporting for quality improvement and patient safety purposes could be used to punish providers and the organizations in which they practice. This risk can be decreased with appropriate statutory protection.

WHY IS PROTECTION OF PATIENT SAFETY AND QUALITY DATA SO IMPORTANT?

Healthcare systems and the individuals providing care in them compose a complex set of interdependent systems, each essential in assuring the delivery of a quality final product. Providers of healthcare have self-evaluated their quality performance in a variety of ways for many years. The emphasis of such evaluation has always been on improvement of processes, human performance, or systems. Information collected as a part of a facility's quality-improvement efforts helps providers determine how, when, and where medical mistakes occur and assists providers in developing interventions and methodology to prevent similar occurrences. However, data that are useful to quality managers are also useful to malpractice attorneys pressing legal claims on behalf of patients injured by adverse events. While those who work in healthcare generally appreciate the complexities that are associated with adverse events, the injured patient rarely does, and neither does the general public. And what they understand when they see data about errors is not the complexity of the process, but a system that is failing its customers.

Healthcare administrators have an obligation to examine their people, their processes, and their systems. They also have an obligation to ask tough questions and make sure that action is taken to improve how care is delivered. Fear of legal action, such as lawsuits and professional sanctions, in a punitive environment may chill providers' willingness to generate information about errors, thereby limiting what can be learned about medical mistakes. To encourage physicians to review the work and behavior of their colleagues with candor, and for healthcare administrators to effectively evaluate their systems and processes, it is important to understand the statutory protections that are afforded to quality data. When information is handled in a manner inconsistent with statutory provision, the privilege and protection afforded under the statutes may be compromised.

THE ENVIRONMENT

At the national level there is continued pressure for providers to publicly report quality data. The CMS Hospital Quality Initiative1 has objectives that include having standardized reporting of quality measures from hospitals across the United States. The CMS objectives also include development of a forum to make the data from this reporting publicly available for use by consumers in making decisions about where to seek treatment. This voluntary reporting initiative has been tied to market basket increases in Medicare reimbursement for hospitals. Implementation of this process makes it financially impossible for hospitals to choose not to participate. Although these data now reside in a publicly accessible database and are accessible via the Internet to consumers, it is still, in many circumstances, the same data that are used by providers to analyze quality of care delivery in their organizations and to determine opportunities to improve systems and processes of care delivery.

While this information is being reported to a federal database and will be available to the public, there are no legal assurances that individuals and their legal counsel cannot use these data in support of purported medical malpractice. This information should be afforded some level of legal protection in regards to providers who are reporting the data. In proposed amendments to the Public Health Service Act-HR 663 and SB 720, otherwise known as the Patient Safety and Quality Improvement Act of 2003-it is proposed that there be formal designation of national patient safety organizations and that these organizations be afforded statutory protections. It is believed that these federal protections will enhance voluntary reporting of patient safety data and thus provide accurate national benchmarking data with which to improve care and enhance patient safety.

This is a beginning in recognizing the recommendations of the Institute of Medicine (IOM) report,2 that called on Congress to provide legal protections with respect to information reported for purposes of quality improvement and patient safety. While these proposed legislative initiatives were not successful in the 2004 federal legislative session, it is likely that they will successfully be reintroduced in the 109th Congress.

Finding balance in the need for public reporting, the use of centralized databases for analysis of error to enhance patient safety, and the implementation of sound, quality improvement programs in healthcare systems along with appropriate legal protections is essential. This balance will support the work of healthcare administrators in building the environment that successfully promotes frank and honest conversations to address medical errors in healthcare.

If those in healthcare really want to enhance patient safety, they must have the ability to evaluate errors without fear of retribution. The development of a blameless culture for provision of patient care can only be done with assurances that the errors, or near misses, that are reported cannot be used to punish the individual and will be used to improve the system. There must be a climate that encourages practitioners to self disclose errors free from fear of litigation and supports frank and honest discussions. The work being done by the Agency for Healthcare Research and Quality, CMS, JCAHO, and other national organizations regarding patient safety focuses on two levels: one, having the data available to caregivers to benchmark and improve their performance; and two, consumer access to information to make informed healthcare decisions.

Healthcare and consumer agencies must find balance in these purposes and assure that a system is designed to collect accurate data in an understandable manner. This will ensure that consumers have information to make informed healthcare decisions. It is also important that healthcare providers and public policy makers are cautious that the information given to patients via public patient safety databases does not give patients information that leads them to the wrong conclusions.

CONCLUSION

Without statutory protection of quality data reported for the purpose of quality improvement and patient safety, there is risk of building a system that can and likely will be used to punish the providers so desperately needed in the healthcare system. Whatever conclusions are made regarding public reporting of patient safety and quality improvement data, the recommendations in the IOM report To Err is Human2 must be taken seriously along with action to build legal protections at both the state and federal level in conjunction with the mandate to report.

REFERENCES