One year after the law’s passage, the Patient Safety Authority has an 11-member board and an administrator. But it is still working to find an outside vendor to handle the medical-error data gathering and analysis processes. Mandatory reporting of medical errors to the PSA likely won’t begin until sometime this fall, estimated Alan Rabinowitz, the authority’s new administrator.

The growing criticism of the authority’s pace of operation highlights just how high medical-error reduction efforts have risen on the state legislative agenda. The implementation of Act 13 is being watched closely because the law addresses two sides of the same coin: malpractice tort reform and patient safety.

The law is premised on the belief that a malpractice system that blames individuals is actually an impediment to improving patient safety. Thus, Act 13 set up an infrastructure to allow medical errors to be viewed in their systemic context, rather than from an individual-blame context.

But it remains to be seen if Act 13 will do what legislators intended on the patient-safety front. The devil is in the details, many of which rest with the Patient Safety Authority getting off the ground. In addition, some legislators are introducing still more patient protection measures into the General Assembly.

Impatience About Start-Up

William Casey, counsel to Senate Democratic Whip Michael O’Pake, expressed impatience with the Patient Safety Authority’s performance.

"The gist of the issue is that the Patient Safety Authority has accomplished very little of what it’s been expected to accomplish. Statutorily, they’re required to submit their first report May 1 to the Department of Health and the General Assembly. It’s not going to happen," Casey said.

Barbara Grill, press secretary for House Democratic Leader William DeWeese, echoed that criticism.

"We believe that the Patient Safety Authority is moving along too slowly and that we do need to strengthen patient safety measures outside of this authority," Grill said.

In particular, she said DeWeese is considering physician profiling legislation as a way to give patients more information about who is treating them. Such legislation would call for a web site or some other public forum where patients could view general details of a physician’s medical malpractice awards or settlements, for example.

Grill said the House Democratic leader’s staff is currently studying the physician profiling model used in Massachusetts, which makes public physicians’ paid malpractice claims within the last 10 years. The state’s system lists the number of payments made due to the settlement of a malpractice claim, or a judgment against the doctor in a malpractice suit, or when an arbitration award is made. The profile doesn’t include dollar amounts, but instead lists whether the amount was below, equal to or above the average of malpractice payments made in the physician’s specialty.

Grill said DeWeese is waiting for Gov. Rendell’s Task Force on Malpractice Reform to complete its work before moving ahead with any additional legislation.

Building From Ground Up

The authority’s Rabinowitz, a former chief of staff at the state Department of Health, defended the authority’s performance, saying it had to start from the ground up, including finding and renting office space.

Rabinowitz was named last November to his post, at an annual salary of $84,000.

He said the authority has contracted with Computer Aid Inc. of Allentown, Pa., to write the request-for-proposals document to find an outside contractor to collect and analyze Pennsylvania’s medical error data.

"This is a very complex process and it’s very important that the request for proposals reflects the full intent of the law and desired outcomes," said Rabinowitz.

"We want a detailed RFP that is not prescriptive because we’re looking for a measure of creative response from an experienced information technology contractor, but we don’t want to leave it open-ended either," he said.

Computer Aid Inc. signed a $68,000 contract with the Patient Safety Authority on Feb. 20. Rabinowitz said he expects the request for proposals to be sent out formally in April or May.

From there, he said, it is hoped that the Patient Safety Authority’s medical error reporting system will be implemented on a phased-in basis sometime in the early fall.

Rabinowitz said the authority’s board "is leaning toward an electronic reporting system, although there will likely be some alternative" for individuals who want to make a totally anonymous report of an error.

Specifically, Act 13 requires three types of facilities to report errors: hospitals, birthing centers and ambulatory surgical facilities. Medical errors are divided into two types: serious events and incidents.

Serious events are those which cause death or which compromise patient safety, resulting in an unanticipated injury that requires more health services. Under Act 13, they must be reported to the Department of Health and the Patient Safety Authority.

In addition, medical facilities must give patients and their families written notice of a serious event occurring in the patients’ care within seven days of discovery of the event.

Incidents are events that could have injured a patient but did not and also did not require additional medical services. They must be reported to the Patient Safety Authority only. There is no patient or family notification requirement when incidents occur.

Administrative Outlook

The Patient Safety Authority is funded through a surcharge imposed by the Department of Health on hospitals, birthing centers and ambulatory surgical facilities. Act 13 called for a total of $5 million to be raised the first year. The Health Department set the surcharge at about $105 per licensed bed, meaning that a 300-bed hospital, for example, would have paid $31,761 toward the Patient Safety Trust Fund.

The Department of Health has collected $4.96 million so far, said Richard Lee, deputy secretary for quality assurance.

Rabinowitz said the Patient Safety Authority’s administrative overhead costs will be very small. He and an assistant are the authority’s only two employees.

"Because the charge to the authority is pretty well-defined to contract with an outside entity, it was clear that this would not be an agency that would be growth oriented in its own staff," he said.

"My assumption has been that we will operate with minimal staff - maybe a third or fourth person, but we’re not going to be hiring 20 analysts because we’re contracting with an outside entity," Rabinowitz said.

As for the authority’s goal of analyzing medical error data and making recommendations to improve the system, Rabinowitz said he believes "there is real potential to identify trends and reoccurrences that doesn’t exist now."

The authority, working through its contractor, will monitor medical error reports, keeping an eye out for any trends or common occurrences that should be flagged.

"There’d be no reason to wait if a trend was observed. If it was something of immediate concern, we would contact that specific facility immediately," he added.

Key Connection, Debate

Act 13, with its patient safety and malpractice reform components, goes to the heart of the patient safety debate: will the medical system be made safer by making the malpractice system more or less punitive?

"Patient safety is intimately connected to tort reform," said William Sage, M.D., J.D., principal investigator on The Pew Charitable Trusts Project on Medical Liability in Pennsylvania. A professor at Columbia Law School, he is a nationally known expert on medical malpractice.

"We have learned a lot about medical errors since the last malpractice crisis in the 1980s, including that far too many avoidable errors occur, that faulty systems cause errors in addition to individual lapses, that most injuries resulting from errors never generate lawsuits and that punitive response to error deter physicians from reporting and learning from near misses," he said.

Sage added that meaningful tort reform "is not just a matter of sheltering physicians from lawsuits, but requires improving incentives to discuss safety, reduce errors and compensate injured patients."

In particular, Sage pointed to the two alternatives laid out in a 2002 Institute of Medicine report on "Fostering Rapid Advances in Health Care." He served on the committee that produced the report.

The first alternative is called "provider-based early payment," under which medical facilities would voluntarily agree to deal with medical errors in a new way. They would identify the errors, tell patients about them and pay early compensation. In exchange, the medical facilities liability exposure would be capped and they would be protected from subsequent litigation.

The second IOM option is a statewide administrative resolution approach, which would be more sweeping and not voluntary. A state-based system would determine appropriate compensation for errors and would substitute for litigation.

Sage added that while error reduction would likely mean fewer lawsuit-related costs, there is no proof that reducing errors saves on overall health spending.

"Policy advocates often use budgetary arguments for improvements in health care quality, such as savings from preventive care or early detection and treatment of disease. Experience shows these arguments are usually overstated," he said.

Nevertheless, Sage said, "whether or not it saves money, reducing errors is a good thing."

As for the effectiveness of Act 13, Sage said it’s too early to predict, but that the law is a "reasonable start."

He did praise several facets of the law, citing in particular its requirement that patients be notified immediately in writing when a serious error occurs.

"I think what has emerged (in Act 13) has tremendous promise and sets forth a solid framework for continued progress after the current liability insurance crisis subsides," Sage said.

"In particular, the written notice requirement when serious events occur in hospitals puts Pennsylvania at the forefront of national efforts to involve patients more directly in patient safety," he said.

Sage added that while negotiations prior to passage of Act 13 were difficult, "it was courageous of the stakeholders to set aside their distrust of one another and agree that telling patients about errors is simply the right thing to do."

An Opposing View

Not everyone, however, believes making the system less punitive is the way to proceed.

Public Citizen, a Washington-based consumer watchdog group, takes a different view.

"A lot of what we hear from patient safety reformers is that we need to eliminate the culture of shame and blame - that we need to look at things as a system and not blame physicians. I think there is some merit to that but to suggest that approach should be taken to the exclusion of the accountability approach, I disagree with that," said Jackson Williams, Public Citizen’s legislative counsel.

Williams said three factors hold doctors and hospitals accountable: the tort system, the disciplinary system and the market place.

"Our feeling is that the tort system is the only thing that’s working of those three and it makes no sense to water it down. ... We need to keep up these three accountability approaches and add a patient safety approach. But don’t link an increase in patient safety systems approach with a decrease in the accountability approach. That’s what I see your Act 13 doing," Williams said.

He added that while there are inefficiencies in the current medical malpractice tort system - such as its expense and long waiting times - capping the amounts paid is not a way to lower costs.

"Lowering the amount paid (out in awards) doesn’t lower costs -it shifts the costs. The costs will always be there. They may not be compensated but they’ll always be there," he said.

"The only way to reduce the cost of the tort system is to reduce the cost of injuries. That’s where the weeding out of bad docs, etc. comes in," Williams said.

Public Citizen issued a report in February claiming that Pennsylvania has the highest rate in the nation of physicians who repeatedly settle or lose medical malpractice lawsuits. The report said that half of all the money awarded in Pennsylvania medical malpractice cases was paid on behalf of doctors settling three or more complaints, while only 5.1 percent of physicians who made five or more malpractice payments were disciplined by the state board of medicine.

The Pennsylvania Medical Society vehemently disputed the consumer group’s data, saying that it either "used faulty analysis ... or intentionally inflated the statistics to deceive the public."

Similarly, the state Board of Medicine disputed Public Citizen’s findings. A board spokeswoman said that the board is diligent in its tracking and prosecuting of cases.

The number of cases opened by the board doubled to 1,664 in 2001 from 834 cases in 2000, according to the board’s 2002 annual report. Actual suspension of licenses, however, remained flat in both years, with the board suspending 32 physicians’ licenses in 2000 and 2001.

Hospitals’ Reporting Squeeze

As the Patient Safety Authority works to get its reporting system in gear, physicians and hospitals are doing their own preparations.

One key challenge facing hospitals, surgical facilities and birthing centers - as well as the health department and Patient Safety Authority - is coordinating what gets reported and to whom.

That’s because the Department of Health has had its own mandatory medical-error reporting law since 1997. Known as "Chapter 51" reporting, the state’s hospitals, nursing facilities and ambulatory surgical facilities must report serious events to the Department of Health.

But Act 13 altered the definitions of what needs to be reported and to whom. For example, medical incidents - also referred to as near-misses - don’t need to be reported under Chapter 51 of the Health Care Facilities Act. But under Act 13, facilities will have to report them to the Patient Safety Authority.

In addition, Act 13 required facilities to appoint patient safety officers, get patient safety plans approved by the state Department of Health, and hold regular meetings of newly formed patient safety committees.

All of which has caused some headaches for the state’s hospitals and health systems.

"We have hospitals in this inbetween land of reporting (errors) under Chapter 51 but trying to manage things with patient safety committees to get ready to report under Act 13," said Lynn Leighton, director of clinical services for the Hospital & Healthsystem Association of Pennsylvania.

"Right now, all these definitions are not real clean and it’s a little bit of a struggle," Leighton said.

The health department’s Lee acknowledged such difficulties and said that he considers one of his department’s main responsibilities under Act 13 is "to adjust Chapter 51 reporting to fit in with the new Patient Safety Authority data."

The Health Department reviews all Chapter 51 medical-error reports and acts on them, depending on their severity. But he noted that the department regulates facilities, while the Department of State - through it medical professional boards - regulates individual practitioners.

So if a Chapter 51 error report flagged an apparent act of gross negligence on the part of a doctor, the department would share that information with the state Board of Medicine, which licenses the state’s doctors. The board would handle the error report investigation from there, Lee said.

Under Chapter 51, the health department has sanctioning powers. The department, for example, recently re-issued Central Montgomery Medical Center’s full operating license after fining it $12,700 for not reporting two medication mix-ups, the Philadelphia Inquirer reported.

Other Legislative Approaches

While Act 13 is sweeping in its provisions on malpractice reform and patient safety measures, few would argue it is the end-all and be-all.

In fact, state Rep. Phyllis Mundy, a Democrat from Kingston, Luzerne County, recently introduced two bills aimed at shoring up patient safety.

House Bill 845 would offer health providers a 20 percent discount on their medical malpractice premiums if they implemented a Department of Health-approved total quality management system, such as ISO-9000 for health care.

"I’d like to prevent errors before they occur and I think focusing on total quality management in the health care field is the way to go about that," Mundy said.

She added that the 20 percent discount would be "negotiable" in the legislative process - and that the measure would be voluntary.

Mundy also introduced House Bill 204 that would require any health care facility, before being licensed, to prove that it can perform enough procedures of a certain type to be clinically effective. Facilities would have to perform at least the minimum number of procedures in any given specialty as set by the Health Department before being licensed.

"There are standards in place now" about how many open-heart surgeries need to be performed for a facility to be clinically effective, for example, "but they’re not tied to licensure," Mundy said.

Despite criticism from some circles, several health care observers said they remain optimistic about provisions of Act 13.

Allen Vaida, executive director of the Institute for Safe Medication Practices, said Act 13 has great potential because it mandates "that something be done with the (error) data that is collected."

"There are a lot of states with reporting programs, but the question is: what do you do with the information that doctors and hospitals are giving you? Many times, the information goes into a black hole," Vaida said.

The Huntingdon Valley, Pa.-based institute is preparing to jointly bid with ECRI, a Plymouth Meeting, Pa. nonprofit health services research agency for the Patient Safety Authority contract, Vaida said.

"We’ve always believed that medical errors occur largely because there are system problems and you shouldn’t point fingers at individuals to try to fix the system," he added.

"Now that thinking is popular and we continue to promote voluntary, non-punitive reporting" of errors, he said.