New Jersey Reporter/Epicenter Conferences
Health Care Quality and Patient Safety: The Cost of Reform, the Cost of Doing Nothing
By Mark J. Magyar

During a 16-year career in which he was fired or asked to leave six New Jersey and Pennsylvania hospitals, nurse Charles Cullen was investigated for homicide, was found to be hoarding powerful heart medications, was convicted of breaking-and-entering, made at least three suicide attempts, and exhibited all sorts of additional suspicious behavior.

Yet these transgressions – and a more difficult-to-discern pattern of suspicious deaths and higher mortality rates during the shifts Cullen worked, particularly after joining the staff of the Somerset Medical Center in 2002 – were never reported to the New Jersey Nursing Board or other authorities who could have flagged Cullen’s behavior. Instead, Cullen succeeded in intentionally administering fatal drug overdoses to up to 40 patients, many of whom appeared to their families to be doing fine, but were dead by morning.

While Cullen’s murders were intentional, the systemic failures that enabled Cullen’s behavior to evade detection are part of a much larger problem in the American health care system.

Inadequate oversight and information-sharing, nursing shortages, the failure to implement new technologies because of fiscal constraints, and a culture of secrecy exacerbated by fear of malpractice lawsuits are among the leading factors that are blamed for tens of thousands of needless patient deaths due to medical errors every year.

The crisis in “health care quality” – a term that understates what is in reality a life-and-death issue – is a national disease, but various health care quality rankings show that the symptoms are particularly acute in New Jersey.

While the National Institute of Medicine’s 2000 report, To Err is Human: Building a Safer Health System, first captured national headlines with its estimate that 44,000 to 98,000 Americans die unnecessarily every year due to preventable medical error, the state-by-state health quality data released by Dr. Stephen F. Jencks, Director of the Quality Improvement Group for the Centers for Medicare and Medicaid Services, was equally shocking.

Jencks’ study of 1999 treatment afforded to Medicare patients nationwide showed that New Jersey ranked 41st out of the 50 states – and last in the Northeast – on a broad range of health quality “best practices.” Two years later, when Jencks repeated the study – whose results were released this year -- New Jersey had dropped to 43rd and ranked in the bottom quartile in improvements made between the 1999 and 2001 studies.
“There is no question that the Jencks study accurately reflects a poor state of affairs in New Jersey,” said Dr. Joel C. Cantor, director of the Center for State Health Policy at Rutgers University.

Extrapolating from the National Institute of Medicine’s estimates, David Knowlton, a former deputy state health commissioner who heads the New Jersey Health Care Quality Institute, estimates that more than 1,700 New Jerseyans die unnecessarily each year due to medical error.
“ We can – and should – do better,” said Dr. Clifton Lacy, state Commissioner of Health and Senior Services. “Quality, cost and access are the major issues facing our health care system, and they are inextricably linked.

“ Poor quality drives up costs because we have to spend more money fixing mistakes and providing expensive acute care for chronic problems that should have been addressed earlier,” Lacy said. “And rising health care costs make health insurance less affordable, which increases the already large number of uninsured patients that are such a burden to the system.”

A 1999 study cited by the Institute of Medicine estimated the national cost of medical errors at $37.6 billion a year, including $17 billion from medical errors that should have been preventable. These figures were the equivalent of 4 percent of total national health care expenditures – more than the total amount spent caring for AIDS and HIV patients.

"Medical errors are a growing concern with regard to the quality of care that people receive and the additional cost that they add to the system,” said Michele K. Guhl, President of the Association of Health Plans of New Jersey and a former state Commissioner of Human Services.
In New Jersey, the reports by Jencks and the National Institute of Medicine sparked a wave of external pressure from health payer groups and internal reforms throughout the health care industry, particularly hospitals, which have put increased effort and clout into multidisciplinary quality review boards.

The state Department of Health and Senior Services has issued highly publicized reports that ranked New Jersey nursing homes, HMOs and hospitals on quality issues, and a state judge ruled that malpractice settlements by physicians were matters of public record, prompting their publication in newspapers and on the Web.

With the bargaining power of the New Jersey Medical Society weakened within the Democratic-controlled Legislature as a result of a noisy battle over medical malpractice reform, Senator Joseph Vitale managed to win passage of the Patient Safety Act, which is designed to ensure that hospitals and other health care facilities report medical errors.

In response to the growing din of concern over the Cullen case, a second Vitale bill is pending that would shield hospitals and other health care facilities against lawsuits for reporting unflattering information about employees, while requiring criminal background checks of health care workers whose licenses are up for renewal.
“New Jersey’s health care quality rankings are poor compared to the rest of the country,” Vitale noted. “Hopefully, the new medical reporting law will begin to correct that. When acute care and long-term care facilities are able to compare the causes of human and technical error, that will go a long way toward preventing the same mistake in the future.
“ The health care system operates within a culture of secrecy,” he said. “We’re trying to create a culture of cooperation, and we think we can do that by protecting the confidentiality of the information reported from being used in lawsuits. It’s going to be up to the state Department of Health to do its job and to make sure that information on systemic errors is shared throughout the system.”

Rating the Quality of Care

While the Institute of Medicine report and the Jencks study elevated the issue of health quality and medical errors, they are not without their critics.
The Institute of Medicine report made national headlines with its estimate of 44,000 to 98,000 unnecessary patient deaths per year, but examination of the estimate shows that it was based on a pair of studies of 15,000 nonpsychiatric discharges in Colorado and Utah in 1992 and 30,195 cases in New York State hospitals in 1984.

A subsequent study by the federal Agency for Health Care Research and Quality concluded that 33,000 patients die each year due to medical error, although it cautioned that its estimate might be low.

Fixing such a number is difficult even with perfect reporting systems, however, and the extent of medical error reporting systems can vary widely from state to state and from hospital to hospital. A 2003 examination of New Jersey’s medical error reporting system by the Star-Ledger’s Carol Campbell, which included an examination of hospital error reports filed with the state, found significant underreporting of medical errors.
Furthermore, internal investigations in New Jersey and Pennsylvania hospitals where “killer nurse” Charles Cullen worked has revealed just how difficult it is to draw a line between deaths due to error and “normal” deaths.

In fact, Dr. Richard Goldstein, President of the New Jersey Council of Teaching Hospitals, said hospitals and physicians may know less about causes of death today because fewer and fewer autopsies are being performed.

As to the Jencks data that benchmarks New Jersey against other states in following “best practices” for health care quality, Aline Holmes, director of the New Jersey Hospital Association’s Quality Institute, noted that the Jencks studies focus on whether specific processes are followed, not on patient outcomes. but she acknowledged that the methodology is basically sound because the Center for Medicare and Medicaid Services audits the data.

“ The best measure really is patient outcomes,” said Dr. John Brennan, Vice President of Emergency Medicine at the nine-hospital St. Barnabas Health Care System. “Yes, the use of beta-blockers for patients with myocardial infarctions is generally the best practice, but some patients are right not to have the medication. But that is what the Jencks study measures.”

Nevertheless, Commissioner Lacy, Goldstein, Knowlton and Cantor assert that the Jencks data, in particular, provides a valid benchmark for the quality of the health care practiced in New Jersey.

“ The practices measured by the Jencks study are truly no-brainers,” Lacy said. “No one can argue that these are not the practices that should be followed in the vast majority of cases, and that following these practices saves lives.”

“We don’t know why the rankings are so low,” Goldstein said. “But we can offer educated hypotheses.”
Based on research, Cantor and other experts point to a series of factors.

First, the New Jersey marketplace is particularly competitive. Hospitals are squeezed financially, which makes it difficult for them to invest in quality programs. “One reason New Jersey hospitals are constrained is that there are too many of them, so they are in a lousy bargaining position with the State, insurance companies and payer coalitions,” Cantor said. “Furthermore, there have been reductions in payments at the federal level. Medicaid has always been a very constrained payer, and Medicare has tightened up over the years.”

Second, New Jersey has a high proportion of specialty physicians and subspecialty physicians, which makes the coordination of hospital care for patients much more complicated.

“ Often, it’s not clear who’s responsible for which decision, and more things can go wrong when there are more practitioners involved making handoffs,” Cantor said. “If somebody is in the hospital with a serious condition, he may have a cardiologist and a pulmonist and an internist all from different practices.” This also contributes to New Jersey’s above-average length of hospital stay and average hospital costs that are among the highest in the nation, Cantor said.

Both Holmes and Deborah Briggs, Senior Vice President for Health Policy and Advocacy for the New Jersey Council of Teaching Hospitals, noted that New Jersey has many one, two and three doctor practices packed into a densely populated state, and that patients frequently move from doctor’s office to doctor’s office with no medical records on prior treatment.

Fourth, New Jersey hospitals and physicians have been slow to embrace the Computerized Pharmaceutical Order Entry system and other electronic technology that eliminates medical errors caused by poor or illegible handwriting. Part of the reason is financial: Information technology systems are expensive for small doctor’s offices and for financially strapped hospitals alike.

No entity in New Jersey has taken on the leadership role that the Massachusetts Medical Society has exercised in seeking to get all physicians to use the same computerized pharmaceutical entry system in that state.

“ If there were resources available, for example, for moving toward computerized order entry, that would be a good use of public funds,” Cantor said. “Data linkage across systems – Medicaid and Pharmaceutical Assistance for the Aged and Disabled (PAAD) – would be tremendously helpful in cutting medical errors, as would bringing in technology that flags staff when information is needed from records and reminds staff to administer aspirin at discharge for heart attack patients.

“ The technology is there, but the will and the money isn’t,” he said.

Fifth, Jencks himself noted the relatively low ratio of Registered Nurses to patients in New Jersey hospitals.

Sixth, New Jersey may have too many hospitals performing too many complex operations.

“ One of the Leapfrog group’s three initiatives to improve quality focuses on the volume of operations performed as a measure of success,” Brennan noted. “This is a little controversial because the New England Journal of Medicine just came out and said it’s not the particular volume of cases a hospital gets, but the volume a particular physician does. It’s probably a mixture of the two. If you have physicians with expertise at a hospital that handles a lot of spinal trauma cases, you’re going to get better results on average than by going to a hospital or a doctor that rarely handles such cases.”

Finally, most experts agreed that New Jersey state government and its health care sector were relatively late to focus on the quality issue. “Leadership counts,” Cantor said.

Over the past several years, Commissioner Lacy has used the bully pulpit of his office to bring attention to bear on health care quality issues.
Lacy followed up on the Jencks data by issuing a pair of reports in July that ranked New Jersey’s hospitals on their treatment of heart attacks and pneumonia in the same way that the Jencks study ranked individual states. (The full report can be accessed on the web at www.doh.state.nj.us.)

“ This report allows hospitals to see how well they perform compared to their peers and to hospitals statewide,” said Dr. Peter Gross, chair of internal medicine at Hackensack University Medical Center and co-chair of the Health Department’s Quality Improvement Advisory Committee.
Lacy released the report at Robert Wood Johnson Hospital Hamilton, which ranked in the top five statewide on both sets of measures.

“ Providing information like this is critical to empowering patients to make decisions about their own care,” Vitale said. “Information is power, especially in a health care system where so little information has been available for such a long time.”

Hospitals: Quality Through Collaboration

Hospital systems like St. Barnabas, Robert Wood Johnson and Atlantic Health System have been putting increasing emphasis on cross-disciplinary quality initiatives and internal reporting. The St. Barnabas program, for example, brings together the system’s seven vice presidents and the chairs of the medical societies of each of St. Barnabas’ nine hospitals in a working group that oversees a series of specialty committees that have created their own report cards and protocols for best practices.

“ We have finally come into an era where electronic information systems are sufficiently sophisticated for us to collect and measure data and spot trends,” Brennan said. “Just as important as the technology, however, is the commitment of the front-line personnel to make a difference for patient. We’re all going through a cultural change in how we work.”

The New Jersey Hospital Association has created its own Quality Institute to coordinate quality activities across hospitals statewide.
“ We haven’t paid enough attention to quality in the past,” said Aline Holmes, a Registered Nurse in Vietnam who served as a Director of Nursing and as CEO in New Jersey hospitals before taking over as director of the NJHA’s new Quality Institute.

The NJHA Quality Institute has set a series of specific goals, including reducing the intensive-care mortality rate in New Jersey hospitals by 20 percent by May 2005, cutting the average length of stay in intensive-care units by one day, and trimming the cost by 20 percent.

The focus on intensive care is logical: The national Leapfrog initiative, which is being spearheaded in the Garden State by the New Jersey Health Care Payers Coalition, made the presence of specially-trained intensivists one of its three priority initiatives for improving health care quality.
While some New Jersey hospitals have intensivists, Brennan noted, other hospitals at looking at creating VISCU (Virtual ICU) units where intensivists can monitor care electronically from centralized stations, a practice that is underway in other states.

Other NJHA Quality Institute goals include reducing the incidence of both vertebrae-associated pneumonia and catheter-related blood infection to the 25th percentile on the Centers for Disease Control rankings.

The Quality Institute has drafted standard protocols for marking a surgical site and a list of banned abbreviations that are prone to mix-up and subsequent medical error. Other Quality Institute committees are working on best practices for computerized pharmaceutical order entry, bar coding of patients, radio frequency identification systems and other information technology advances that could eliminate as much as one-third of all medical errors.

The mix of leadership on quality initiatives in New Jersey is unusual in that it is being led by state officials, health payer groups and hospitals.
“I know that in some states, including Maine, New Hampshire and Vermont (which ranked as the top three states in both Jencks studies), the quality improvement effort has had a lot of medical staff leadership,” Holmes said. “We have not had as much physician leadership in this state.”
New Jersey’s physicians would not necessarily disagree with Holmes’ statement. The reason, they would say, is malpractice.

Physicians: The Impact of Malpractice

To Dr. S. Manzoor Abidi, a neurologist and the new President of the Medical Society of New Jersey, it’s hard to talk about quality without talking about malpractice
Interviewed the week that the Star-Ledger and other newspapers ran front-page stories that listed the names of physicians and the malpractice awards they had paid, Abidi was fuming.

“ Doctors want zero percent mistakes, but it’s hard for hospitals, doctors or nurses to report those mistakes when we have no confidence that the information won’t be used against us,” Abidi said.

He and state Medical Society Executive Director Michael Kornett praised the provision of Vitale’s new law that promised confidentiality on the reporting of medical errors, but noted that malpractice settlements were supposedly confidential too.

“ Now that physicians are being branded in the papers with a Scarlet Letter, the incentive is going to be to fight every case,” Kornett said.
Abidi and other physicians argue that “there is a difference between malpractice and maloccurrence.”

“ I’m a neurologist, and the vast majority of cases of cerebral palsy are genetically determined long before a child is delivered,” Abidi said. “But juries award huge multi-million-dollar settlements because they feel sorry for the family and they think the insurance company has deep pockets. Liability insurance goes up and physicians are forced to practice defensive medicine. We could save several billion dollars in insurance costs and cover the costs of the uninsured and charity case if we could reform the system.”

Abidi noted that his son, a top orthopedic surgeon, decided not to practice in Philadelphia or South Jersey, where malpractice insurance would have cost $175,000, and moved to California, where he pays $49,000 a year.

Nicholas Abidi isn’t alone.“ What scares the hell out of me is that none of our OB/GYN residents are staying in New Jersey because of the malpractice situation,” said Dr. Ronald Librizzi, President of the Obstetrical/Gynecological Society of New Jersey. “We need to do something before we have an access to care problem. We only have half the OB/GYNs we had a few years ago.”

As a result, the doctor pool in New Jersey is steadily getting older.

“ In 1970, 35 percent of New Jersey physicians were below the age of 35,” Abidi noted. “Today, we’re down to 8 percent. Where are all the young physicians? They’re going to states with low malpractice costs.”

The aging physician pool has an impact on quality, said New Jersey Council of Teaching Hospitals’ Deborah Briggs.
“ Younger physicians who grew up with computers are going to be more comfortable with computerized order entry,” she said, “and they are also more willing to join larger practices as employees, rather than hanging out their own shingle. Larger practices can better afford the newest technology.”

Vitale, one of the Democrats targeted by the Medical Society of New Jersey’s expensive, but unsuccessful, effort to put Republicans in control of the Legislature in the 2003 election in an effort to win malpractice reform, dismissed the physicians’ arguments seeking to link quality to malpractice reform. “Whatever you try to do, all they want to talk about is malpractice,” he said with exasperation.

But tort reform is essential not only to improving quality, but to controlling cost, Brennan contended. “The high costs of defensive medicine to protect against lawsuits is money that should be going into improving the quality of care,” he said.

Nurses: The RN Shortage

In examining the reasons for New Jersey’s low ranking in his study, Dr. Jencks concluded that New Jersey’s relatively low staffing ratio of Registered Nurses to patients had the strongest correlation to the state’s relatively poor results. He would get no argument from New Jersey nurses.
“ We have always felt certain that the RN staffing levels had a lot to do with it when we’ve tried to figure out why things are so chaotic and how to improve the system,” said Sharon Rainer, associate director of the New Jersey Nurses Association.

Rainer cites an Eagleton Poll that shows 80 percent of New Jerseyans believe nursing levels should be mandated by the state government, but acknowledges that “there has not been much support for mandating nursing ratios in the Legislature because they believe the Hospital Association’s argument that there is a nursing shortage.”

The problem, she said, goes deeper than that. “Our nursing schools are full, we have long waiting lists, but when nurses come out, they only last a year,” she said. “The problem is not getting new nurses into hospitals, it’s keeping them there.” The problem, she said, is at least partially due to the work environment.

Vitale agreed that the Legislature needs to work on increasing the numbers of Registered Nurses, but asserted that the solution lies in tuition assistance plans that will enable nurses with associate’s degrees and degrees from diploma schools to go back to complete their RN training and earn baccalaureate degrees.

“ There is a national nursing shortage,” Vitale insisted, “and the only way we could fill the nursing void in our hospitals was to expedite the entry of more and more nurses with only two or three years of training into the system. That’s a trend we need to reverse.”

The Role of State Policy: The Future
Richard Goldstein is frustrated.

“ We are on the threshold of amazing new changes in the delivery of health care,” Goldstein said. “We’re less than 10 years out from making real use of the benefits of stem cell research. Genomics and nanotechnology hold great promise for the quality of health care, all of which will have major implications for health care policy. But our system of health care governance simply isn’t up to the task.

“When I was health commissioner, we had a highly regulated system,” Goldstein said. “The commissioner today doesn’t have all the powers I had. Today, no one person is in charge of quality, financial issues and operational efficiency. Instead, we have responsibility for health care falling under seven different departments, and all of the overlapping bureaucracies and regulations do not make it easy to create the necessary change.”

Goldstein said the health commissioner’s powers began to shrink when the much-maligned DRG hospital rate-setting system was abolished in 1992 and 1993, just before he took office with the new Whitman administration. The DRG system collapsed, Goldstein contended, not because it was inefficient, but because the burden of paying for charity care added first 19 percent, then 23 percent to hospital bills.

Goldstein’s New Jersey Council of Teaching Hospitals has issued a State Government Reform Plan that urges the state government to develop a 10-year strategic plan for health care reform and create a Health Agency Oversight Board chaired by a single commissioner as the ultimate authority for health care reform as its top two priorities

“ We need to figure out a new strategy that puts one person in charge of health care, whether it is the health commissioner or a health czar in the Governor’s Office,” said Goldstein. “And we need to put a system in place so that 10 years from now, we are all working with the same information technology system.”

Mark J. Magyar is President of the Public Policy Center of New Jersey and Editor of New Jersey Reporter.