This skeptical view is supported by the trial lawyers’ trumpeting of medical error data from the Institute of Medicine’s (IOM) landmark 1999 report, To Err Is Human: Building a Safer Health System, without recognizing the report’s fundamental contention that "the focus must shift from blaming individuals for past errors to a focus on preventing future errors by designing safety into the system."

If health care providers pointed out this selective use of the IOM report or engaged in serious consideration of the issue, at least publicly, they risked contributing to a shift in focus away from "lawsuit abuse" to medical errors.

In the end, however, malpractice reform and patient safety became inextricably combined in the legislation. But while the connection between medical errors and medical malpractice is undeniable, the relationship between error reduction measures and malpractice litigation is complex, with the two frequently at odds with each other.

As the IOM report points out, reporting of errors is necessary for designing error reduction initiatives, but fear of litigation frequently prevents errors from being reported in the first place. Litigation also saps resources out of the health care system that could otherwise be used to institute expensive safety initiatives such as computerized physician order entry. And while Gov. Schweiker has said that the law’s patient safety measures will provide up to a five percent reduction in malpractice insurance premiums, the law’s requirement that patients be notified about medical errors could lead to an increase in malpractice liability.

Details of the New Law

The patient safety provisions of Pa.’s new law, much like the IOM recommendations, establish a structure and process rather than particular patient safety measures. The provisions also provide no funding for implementing patient safety measures. They strike a balance between a systems approach designed to prevent future errors, which is favored by hospitals and physicians, and an approach designed to hold health care providers accountable for errors, which is favored by trial lawyers.

The centerpiece is the establishment of a Patient Safety Authority. The Authority will be chaired by the state physician general, and include five other Pa. health care professionals appointed by the governor, and five residents of the state appointed by the legislature and governor. The primary function of the Authority is to collect and analyze data about medical errors in the state and issue recommendations for changes in health care practices and procedures to reduce medical errors. The Authority must contract with a company that will actually do the data collection and analysis as well as recommend changes in health care practices, which ultimately require the approval of the state Department of Health. Medical facility compliance with recommended changes can be considered by the Health Department as part of licensure decisions, but cannot be considered mandatory unless adopted as a department regulation. The Authority must issue an annual report of its activities and findings to the Health Department and Legislature, including recommendations for statutory or regulatory changes to improve patient safety. Safety performance and trends and recommended changes must be communicated to medical facilities and posted on a website accessible to the public. Funding for the Authority will be raised through a surcharge paid by medical facilities on top of their licensing fees.

Medical facilities—defined as ambulatory surgical centers, birth centers and hospitals—must develop, implement and comply with an internal patient safety plan, which must be approved by the state Health Department. The safety plan must designate a patient safety officer, establish a patient safety committee, establish a system for health care workers to report medical errors, prohibit retaliation against a health care worker for reporting a medical error, and provide for notification to patients affected by medical errors defined as "serious events."

The law divides medical errors into two types: serious events and incidents. A medical error is treated as a serious event if the clinical care of a patient in a medical facility (1) causes the patient’s death or (2) compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. Clinical care in a medical facility is considered an incident if it could have injured a patient, but did not cause an unanticipated injury or require the delivery of additional health care services to the patient.

The IOM report draws a similar distinction between types of errors, but with important differences. The report defines serious adverse events as deaths or serious injuries resulting from a medical intervention, only a subset of which are the result of errors. The second type of error is one that results in no harm or very minimal patient harm, sometimes termed a near miss.

The IOM report distinguishes these two types of errors in order to develop separate error reporting systems: a government-run, mandatory reporting system for serious adverse events and non-governmental, voluntary reporting systems for near misses. The primary purpose of the mandatory system is to hold providers accountable for mistakes, including public disclosure and possible penalties, while the primary purpose of the voluntary system is safety improvement and its data should be protected from disclosure, particularly from litigation. "Protecting such information," the IOM report states, "encourages disclosure of problems and a proactive approach to correcting problems before serious harm occurs."

An entire chapter of the IOM report is devoted to protecting voluntary reporting systems from legal discovery because the prominence of litigation can be a substantial deterrent to the development and maintenance of reporting systems. Perhaps the most provocative passage on the connection between malpractice litigation and medical error reduction is contained in this chapter: "The committee believes that a different approach to promoting the collection, sharing, and analysis of such data . . . would be to change the legal environment in which health care organizations and providers operate. Exclusive enterprise liability, shifting liability for medical injuries from individual practitioners to responsible organizations, has been suggested to possess several advantages over the current liability system. One of these is to remove the fear of personal liability from individual health care workers, eliminating this incentive to hide errors. Another proposed reform, no-fault compensation for medical injuries, might promote reporting by eliminating the adversarial inquiry into fault and blame that characterizes the current liability system."

Instead of establishing separate reporting systems for serious events and incidents, Pa.’s law has a single government-run, mandatory system for both, including disclosure protections for both and somewhat different reporting requirements for serious events and incidents. The Pa. law also requires reporting of infrastructure failures: an undesirable or unintended event, occurrence or situation involving the physical plant or the service delivery systems of a medical facility or the discontinuation or significant disruption of a service which could seriously compromise patient safety.

Health care workers are required to report serious events or incidents to their medical facility within 24 hours. Medical facilities are required to report the occurrence of a serious event or infrastructure failure to the Health Department and the Authority within 24 hours of the medical facility’s confirmation of the occurrence of the serious event. Medical facilities are required to report incidents to the Authority, but not the Health Department, and there is no stipulated time within which it must be reported. The names of individuals involved in the reported serious events and incidents must be left out of the report to the Health Department and Authority. All of these reports are confidential and shall not be discoverable or admissible as evidence in any civil or administrative action or proceeding.

Medical facilities must also notify a patient or his/her family of a serious event occurring in the patient’s care within seven days of the discovery of the serious event. There is no requirement to notify patients of incidents.

There are stiff penalties for not reporting a serious event or infrastructure failure, but no penalty for not reporting an incident. If a medical facility discovers that one of its health care professionals failed to report a serious event, that facility must report the professional to his/her licensing board. A health care worker altering or destroying patient records to cover up errors is a ground for suspension by the state Board of Medicine. A medical facility’s (1) failure to develop and comply with its patient safety plan; (2) failure to report a serious event or infrastructure failure; or (3) failure to notify a patient or his/her family of a serious event, is a violation of the Health Care Facilities Act and is subject to any penalty under that law. In addition, a medical facility that fails to report a serious event or infrastructure failure, or fails to notify a licensure board that one of its health care professionals failed to report a serious event, is subject to an administrative penalty of $1000 per day.

In an effort to link improved patient safety with reduced malpractice insurance premiums, the law provides for patient safety discounts. Medical facilities can apply to the Pa. insurance commissioner for certification of any program recommended by the Authority that results in a reduction in serious incidents at the facility and the commissioner will then determine the level of discount.

Reactions to the New Law

The patient safety provisions of the law are different from proposals originally drafted by the Hospital & Healthsystem Association of Pennsylvania (HAP) and the Pennsylvania Medical Society (PMS), which wanted to grant much more flexibility and autonomy to providers in reporting errors, said PMS General Counsel Ken Jones, Esq.

PMS and HAP had proposed an entirely non-punitive error reporting mechanism—similar to one adopted by the airline industry—to encourage reporting by anyone in the system at any time. Such a system, according to Jones, would more effectively encourage reporting of medical errors by avoiding a focus on fault, creating instead a culture of safety without imposing layers of state rules and penalties.

"We were going to give hospitals and physicians much more latitude on how to improve patient safety, based on their experience," said Jones. For example, he noted, some hospitals might focus on one area of improvement, such as cardiac care, while other hospitals could focus on other contexts of patient safety. The trial lawyers wanted more state and legal oversight, Jones added.

PMS and HAP had also proposed allocating funds drawn from physician licensure fees to the state Medical Board to improve the efficiency of its disciplinary process and allow it to hire a full-time executive director and attorneys from outside the state system, said Jones. The administration was not supportive of that proposal, he noted.

Even though the IOM report and other authoritative studies on medical errors have already highlighted specific interventions—such as automated prescribing systems—as the best ways to reduce the most serious errors, Jones said he would not want specific interventions written into the law, given that studies of medical error interventions have just recently begun.

He believes that Patient Safety Authority’s subcontracting with entities to analyze the error report data will ultimately reduce medical errors by identifying specific problems and recommending improvements. Jones said that he wouldn’t be surprised if automated prescribing systems is one of the Authority’s early suggestions. "The questions is, how much will that cost," Jones added.

Nobody involved in drafting the law discussed automated prescribing systems or any other specific error reduction intervention, nor did they discuss funding for any, said Jones. No one proposed that a portion of malpractice jury awards go to improving the quality of health care, on the assumption that the trial bar would not support such a proposal, Jones added.

No definitive analysis is available of what impact the law’s patient safety provisions will have on medical malpractice premiums, according to Jones. He thinks the Schweiker administration’s estimate that the provisions would reduce premiums by five percent overall is speculative.

Although it would appear that requiring physicians and hospitals to inform patients of serious errors could only increase the number of lawsuits, Jones said that preliminary studies of that issue by the JCAHO and the VA Hospital system suggest that the reporting requirement would not raise liability exposure, and may even reduce it somewhat.

John Combs M.D., of HAP, is optimistic that the new law will encourage reporting of errors. He indicated that the Department of Health has seen dramatic increases in the number of events reported in the past year, which he attributes to increased awareness about patient safety. Furthermore, he indicated that the structure of the new law with patient safety officers in each hospital facilitates reporting and monitoring of compliance with the mandated reporting.

"There is now a clearly defined statutory obligation for facilities to report safety violations. And there are explicit mechanisms for dealing with these reports," said Combs, noting that the new law takes a statewide and systematic approach to improving patient safety by requiring annual reporting to the General Assembly.

The requirement that the Patient Safety Authority contract with an outside third party to administer many of the law’s requirements is designed to ensure that these things get done, Combs added, citing precedents in NASA and other government agencies where program operations have been outsourced as a means to ensure that results are achieved.

Mark Phenicie, legislative counsel for the Pennsylvania Trial Lawyer’s Association (PaTLA) reported that his group feels the law contains valuable provisions for improved safety and said that the patient notification requirement was an important item for attorneys. But he also said the law does not give the public enough information about good and bad doctors.

One of the things that PaTLA wants to see, according to Phenicie, is mandatory open reporting on doctors, similar to what is done in Massachusetts, where details of malpractice settlements against doctors are made available on the Internet and through a toll-free phone number. The other thing PaTLA wants is more action by the Bureau of Professional and Occupational Affairs in reviewing complaints against doctors and disciplining them. He claimed that the Bureau has a backlog of 1,300 complaints and that it has not disciplined a single doctor in two years.