Plague of Errors

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http://governing.com/articles/8med.htm

 

Plague of Errors

 

Hospital infection rates are rising and killing 90,000 patients a year.

Can the states put a stop to it?

 

By JOHN BUNTIN

 

An October evening in 2002 at Allegheny General Hospital in Pittsburgh,

Dr. Rick Shannon faced a crisis: Sixteen patients in two intensive care

units had been exposed to a deadly pulmonary infection. Fearing even

wider exposure, Shannon, the chief of medicine at the hospital, closed

down surgical suites that had been serving the ICU patients and began a

desperate search for the culprit.

 

 

Five days later, his staff had the guilty parties in hand: three

“dirty” bronchoscopes — thin, tubular instruments about the width of a

pencil that allow a physician to directly examine lung tissue and even

take tissue samples. The scopes, which are threaded down a patient’s

nose or mouth and into the windpipe, are marvels of modern medicine.

Their use in most large hospitals is routine. So routine that, in an

effort to keep them readily available to its physicians, Allegheny

General had recently adopted a faster chemical sterilization regime.

The change in procedure turned out to be a disastrous mistake.

 

The patients at Allegheny General that fall evening were relatively

fortunate. Only one died from the infection. However, while the sudden

intensity of the outbreak was unusual, the appearance of a dangerous

infection in a hospital is not. Every year, an estimated 2 million

Americans — approximately 5 percent of hospital patients — contract a

hospital-acquired infection during the course of a hospital stay. Some

90,000 of them die — more than the number of people who die from breast

cancer or automobile accidents. And the situation is getting worse.

Since 1975, the infection rate has escalated by 36 percent.

 

For years, the medical establishment has downplayed the problem, seeing

it as a regrettable side effect of advances in medical technology and

practice. “We have patients that are older with more underlying

disease,” explains Dr. Denise Cardo, director of the division of health

care quality promotion at the Centers for Disease Control and

Prevention. “We do many more underlying procedures than we did before.

We may have more infections, but that’s very different from saying that

we’re not preventing infections.”

 

This position is, however, becoming less and less tenable. Researchers

have been gathering compelling evidence that measures as simple as more

vigorous hand-washing by hospital personnel could save as many as

30,000 patients a year. Moreover, a handful of hospitals, including

Allegheny General in Pittsburgh, have demonstrated that, with active

and appropriate procedures in place, some of the most dangerous

infections — infections that American hospitals have tolerated for

decades — can be dramatically reduced, indeed almost eliminated.

 

To a small but passionate number of policy makers and physicians, what

once appeared to be a tragic side effect of modern medicine now looks

increasingly like a case of inexcusable negligence. State legsilators

and regulators are taking notice. Thirty-two states are currently

considering legislation that would require hospitals to report

hospital-acquired infection to state authorities. Six states — Florida,

Illinois, Missouri, New York, Pennsylvania and Virginia — have already

passed such legislation. But only one — Pennsylvania — is on the verge

of implementing a fully functional system.

 

It is not easy for states to regulate the delivery of health care.

Medicine is a largely self-governing profession. Agencies such as the

CDC have traditionally enjoyed enormous respect — and deference — both

from the public and from states. Hospitals have essentially been

allowed to regulate themselves through voluntary participation in the

Joint Commission on the Accreditation of Health Care Organizations, a

nonprofit group that oversees hospital accreditation. Infection-control

practices have been governed by the Association for Professionals in

Infection Control and the Society for Healthcare Epidemiology of

America.

 

None of these groups are accustomed to being challenged by state

lawmakers or bureaucrats. But that is precisely what is happening in

Pennsylvania, where a previously obscure state agency — the

Pennsylvania Health Care Cost Containment Council (PHC4) — began

collecting infection data from the state’s 180-plus acute-care

hospitals in 2002. Earlier this year, it released information that

suggests Pennsylvania’s hospitals have vastly under-reported the scope

of their infection problems. It also calculated that the four

hospital-acquired infections PHC4 is currently tracking cost the state

Medicaid program and state employees benefits plan upwards of $125

million last year and that the cost to private insurers was even higher

— close to $1 billion. PHC4 also found that a hospital within the state

— Allegheny General — was already pioneering an effective way to combat

the infection problem.

 

PHC4 has taken the position that public accountability — making public

the figures on all infections at every hospital in the state — is the

key to improving health care outcomes. Its critics — and they are

legion within the self-regulatory establishment — argue that

improvement can come not from broadcasting errors but by establishing a

“safe learning environment” where providers can air their mistakes and,

in so doing, improve procedures. At issue is a fundamental question

that every state confronts: What public policy approach will do the

most to save lives?

 

FOUNDING FATHERS

 

PHC4 was created in 1986 as a state health data organization. It was

backed by two constituencies determined to rein in health care costs —

the business community and organized labor. Hospitals were required to

report billing and administrative data to the council. The council,

however, was seen as little more than “a data graveyard,” and it was

almost phased out. But it got a second wind. In 1998, with health care

costs on the rise, Marc Volavka became the executive director of the

council. As chief of staff to former House Speaker Jim Mandarino,

Volavka had drafted the legislation that originally created PHC4. He

was determined to turn the council into an active player in state

health policy. PHC4 started digging into the administrative and billing

data that hospitals in the state are legally obligated to report to the

council. It was during this exercise that PHC4 came across some

disturbing data.

 

As council researchers assessed the scope of complications from care by

looking at hospital readmissions in 2002, they tallied nearly 74,000

readmissions over the preceding 12 months and found that more than

16,000 people were readmitted because of complications arising from

surgery or from infections.

 

The council calculated that if hospitals with higher-than-average

readmission rates could reduce those rates to the state average, the

result would be $115 million a year in savings. The council further

identified 6,000 surgical “misadventures” that resulted in an

additional $365 million in charges. But when the council published this

readmissions data, it met with outright denial. In a letter to the

commission, the chairman of the board of the Pennsylvania Hospital

Association wrote that “the vast majority” of the surgical

misadventures were caused by “accidental punctures or lacerations

during procedures.” The chairman argued that incidents of this sort

should be viewed as “a known risk or anticipated outcome, given the

patient’s medical condition or physiology.” So, too, with infections.

 

The council was no longer willing to accept this proposition. One of

the reasons was a remarkable experiment underway in Pittsburgh in

conjunction with an unusual collaborative known as the Pittsburgh

Regional Health Initiative.

 

AVOIDABLE RISK

 

PRHI is the brainchild of Alcoa chief-turned-Treasury Secretary Paul

O’Neill. Its goal is to apply to hospital practices the principles

Alcoa had used to eliminate workplace errors and thereby improve the

quality of health care in southwestern Pennsylvania. Allegheny General

was one of 40-odd hospitals in the region that had agreed to

participate in the effort, and in the fall of 2001 — a year before

Allegheny General experienced its frightening surge in pulmonary

infections — Rick Shannon got a call from Allegheny General’s chief

executive officer. He wanted Shannon to know that PRHI was preparing

its report on heart surgery success rates and that Allegheny would have

to address some none-too-good numbers. His job at this point, quips

Shannon, was “to go defend our hospital’s honor.”

 

Not a tough job: Since patients at urban teaching hospitals are

typically poorer and sicker than patients at other hospitals, urban

hospital executives confronted with bad numbers almost always argue

that their numbers should be “risk adjusted” to reflect the population

they are serving. But when Shannon arrived at the meeting, something

unusual happened. He found himself agreeing with what was being said.

To wit, that medicine was an industry that could benefit from good

industrial engineering and that hospitals should embrace production

principles pioneered by innovative firms such as Toyota. At that

moment, Shannon says, “I drank the Kool-Aid that changed my life.”

 

When disaster in the form of a pulmonary infection cluster struck in

Allegheny’s ICUs one year later, Shannon was ready to apply these

principles to his own institution. First, he invited people who had had

bronchoscope procedures to come forward for testing, a suggestion that

appalled the hospital’s legal team. His next proposal was even more

radical: completely eliminate one of the most lethal forms of infection

— infections from the central line inserted into a patient’s vein and

used to deliver medications and draw blood samples — from the two ICUs

under his direct control.

 

Any effort to change hospital procedures begins with nurses. When

Shannon presented this goal to the nurses in his ICUs, they had a very

clear reaction: They thought he was crazy. “We thought infections were

just part of having a central line,” says nursing coordinator Pamela

Chapman.

 

They soon learned otherwise. Residents were assigned to review medical

records to discover causes of death. Infections were investigated

immediately and exhaustively. For example, when staff discovered that

bronchoscopes were being cleaned using a quick but ineffective chemical

sterilization process, they asked, “Why do we need to use this faster

process in the first place?” The ultimate answer was surprising:

Physicians were performing more bronchoscopes in response to an upsurge

in ventilator-related pneumonia, which in turn resulted from a change

in antibiotic regime. By drilling down to the root cause of the

problem, Shannon’s team managed to identify causes that might otherwise

have gone undetected. In the year before Shannon instituted his

reforms, 37 patients developed central-line infections, and 51 percent

of those died. In the year that followed the implementation of his

team’s reforms, only 6 patients developed an infection, and only one of

those patients died.

 

The realization that these infections could be prevented had a profound

impact on the ICU. Previously, “nurses were shielded from the emotional

costs by sterile data that said 5.1 infections per 1,000 line days” —

the average infection rate reported by the CDC — “is good,” Shannon

says. “But when the nurses began to see that half the people who get

this die and it’s preventable? It’s preventable. That really changed

things.” Nursing staff were soon developing a whole host of innovative

ways to reduce infections.

 

Allegheny General’s nurses weren’t the only group determined to put a

system in place to support change. So was PHC4. To Marc Volavka and

many council members, Shannon’s findings implied that hospital-acquired

infections were not in fact a regrettable side effect of medical

advances but rather a preventable tragedy. PHC4 determined that the

best way to spur change was to begin publishing hospital infection

rates. In November 2003, PHC4 informed Pennsylvania’s hospitals that

they would have to start reporting infections to the agency, starting

in January 2004.

 

THE COUNTERPOINT

 

Medicine is a status-sensitive profession. Physicians with experience

and credentials are accustomed to being treated respectfully if not

deferentially. In the field of infection control, few are accorded

greater esteem than Dr. P.J. Brennan. As the chief safety officer for

the University of Pennsylvania health system, Brennan is responsible

for the safety of more than 72,000 patients a year. He also is the

chair of the CDC’s Healthcare Infection Control Practices Advisory

Committee.

 

Brennan is by no means an outspoken PHC4 critic. When the council

announced that it planned to address the infection issue, his first

reaction was to call and offer his assistance. However, it’s clear that

on the whole the council’s foray into his specialty has been an

upsetting experience.

 

”In Pennsylvania, there was no involvement of the provider community or

infectious disease control specialists in setting the mandate,” says

Brennan. “And it was done in a rather precipitous way.” As a result, he

worries that patients may suffer as Pennsylvania’s infectious disease

control specialists struggle to respond to new demands to track a whole

array of infections.

 

Brennan’s CDC advisory committee and other PHC4 critics are

particularly disturbed by two aspects of Pennsylvania’s approach: the

attempt to capture outcomes and the use of administrative and billing

data.

 

Instead of focusing on outcomes, the CDC and the Joint Commission on

Accreditation of Health Care Organizations recommend emphasizing

process measures — things such as the proper pre-surgical prophylaxis

and hand-washing. “If you don’t give them the tools to do better, data

won’t help at all,” says Margaret VanAmringe, vice president for public

policy at JCAHCO. “They will find ways to hide data or find some way to

obfuscate.”

 

”You’ve got to work with the community,” she continues. “You can’t just

get up there and badmouth the provider community. It expends political

capital, gets people angry and makes it harder to work with the

provider community after the fact.”

 

At the root of the conflict between PHC4 and its critics is a

philosophical difference about how best to reduce errors and improve

quality. Both camps want “actionable” information that will drive

systemic change. However, PHC4 is focused on providing that information

to purchasers, be they businesses, labor unions, insurers or individual

consumers. In contrast, PHC4’s critics insist that this focus on

purchasers is misguided.

 

”Put out these gross statistics and people get all alarmed, but what

are they going to do with this data?” asks VanAmringe. “If you think

hospitals are going to scramble and fix it, then maybe, but I don’t

think that’s what will happen. I think they will look at the data and

call it what it is — meaningless.”

 

Instead of pursuing the chimera of public accountability, many of

PHC4’s critics have called on the council to learn from other

industries that have successfully reduced errors. The first step is

provider buy-in. The second is to create a safe learning environment

where hospitals can share mistakes and learn from each other — without

fear of litigation.

 

The Pennsylvania Patient Safety Authority, which was created in part in

response to soaring medical malpractice insurance premiums, embodies

this approach. Reports to it are confidential; feedback comes in the

form of periodic “advisories” to the provider community. A look at the

agency’s latest annual report reveals that hospitals reported only 747

instances of hospital-acquired infections. That’s a strikingly small

number — “a lower number than we expected,” says Alan Rabinowitz,

executive director of the agency. However, he’s unconcerned by the low

figure. “Our goal is to reduce patient harm, not count numbers,” he

says.

 

PHC4 has brushed aside these criticisms as ill-formed or off-base — or

worse, as mere efforts to sabotage their efforts. This summer, PHC4

finished collecting its first full year of data. According to council

documents obtained by Governing, Pennsylvania’s 180-odd acute-care

hospitals reported 12,000 infections in 2004 in the four categories the

council was tracking. However, when PHC4 examined billing data, they

found 120,000 cases where hospitals appeared to have billed insurers

for what looked like episodes of infection.

 

When PHC4 staff drilled down even further, they found something

interesting. Of the 180 acute-care hospitals that are legally bound to

report infection data, 20 facilities accounted for 55 percent of the

reported infections; 160 hospitals accounted for the other 45 percent.

If the 20 hospitals that reported the majority of infections

represented a proportionate number of patients, this finding would not

have raised any questions. But that is not the case.

 

Not surprisingly, the Pennsylvania Hospital Association and other

critics reach a very different conclusion about the billing data. “In

fact, billing codes used often do not reflect infections acquired in

hospitals,” Brennan says. The infections could have been acquired in

the community or could be illnesses that hospitals treated as

infections but later determined to have been something else entirely.

In Brennan’s view, the gap between the 12,000 infections reported and

120,000 infections billed “has no significance at all.”

 

Marc Volavka sees things differently. His bottom line: “If you bill for

it and get paid for it, you ought to be accountable for it.”

 

In the face of what it sees as noncompliance, PHC4 has turned up the

pressure. Early this summer, it sent hospitals a letter reminding them

of their obligation to report infections and of the statutory penalty

for noncompliance, fines of up to $10,000 a day. Hospitals also

received information comparing their reporting and billing rates to

other comparable institutions.

 

Beginning in 2006, hospitals will be required to report virtually all

types of infection — a requirement that some infection-control

specialists warn will be ignored as unreasonable or unworkable.

The council has informed the hospital association that beginning in

2006, hospitals will be required to report virtually all other types of

infection — a requirement that some infection-control specialists warn

will be ignored as unreasonable or unworkable.

 

Council members say they’re ready for a confrontation. “We’ve laid a

marker down and any hospital administrator or infectious disease

section head who doesn’t believe it’s coming is about to get a rude

surprise,” says Cliff Shannon, a council member who represents a

Pittsburgh-area business purchasing group. “The legislature’s tolerance

for this is going to be about zero.”

 

For now, though, PHC4 is holding off on reporting hospital-specific

infection data. “The reason we have not released and will not release

hospital-by-hospital information is that the best hospitals in the

state in terms of compliance with the law would be the very ones that

would look the worst,” says Volavka, “and that would be absolutely

unfair.” What remains to be seen is whether the council will ultimately

succeed in extracting accurate data from all of the state’s hospitals.

Volavka says PHC4 is determined to try — even if it means taking on

entrenched interests publicly. “What is not working is quiet, voluntary

collection and fighting over very complicated definitions of what is or

is not infection,” he says.

 

Volavka points out that most of the people opposed to public reporting

today were against it five or 10 years ago when the efforts first got

underway. “They’ll say that public accountability has never been

utilized by consumers, but in those areas where public reporting has

been utilized, it has and does get the attention of the provider

community. And it does force the provider community to improve. I do

believe that public reporting is public accountability. Whether they

like it or not, they are forced to pay attention.”

 

 

" The liberty of a democracy is not safe if the people tolerate the growth of

private power to a point where it becomes stronger than their democratic State

itself. That, in its essence, is Fascism - ownership of government by an

individual, by a group or by any controlling private power. " -Franklin Delano

Roosevelt

 

" I believe there are more instances of the abridgment of the freedom of the

people by gradual and silent encroachments of those in power than by violent and

sudden usurpations. " -James Madison