Senate passes patient safety bill with new error reporting system

From: yelxol (willlocksley_at_aol.com)
Date: 08/03/04 

Date: 2 Aug 2004 18:44:07 -0700

Senate passes patient safety bill with new error reporting system
The measure would allow physicians and hospitals to convey data on
medical mistakes without worrying about sanctions.

By Joel B. Finkelstein, AMNews staff. Aug. 9, 2004.

Washington -- A national system for collecting medical error data
seems closer to reality than ever before.

On July 22, the Senate passed its version of patient safety
legislation, which will now have to be reconciled with the House
measure approved in March of last year. The legislation's proponents
have high hopes that a final agreement can be hammered out and passed
by Congress this year.

The bill has bipartisan support from powerful members of each party,
including Senate Majority Leader Bill Frist, MD (R, Tenn.), and Sens.
Edward Kennedy (D, Mass.) and Judd Gregg (R, N.H.).

"You have all these people saying we have to pass it," said Donald J.
Palmisano, MD, immediate past president of the American Medical
Association, which has been part of a large coalition urging passage.
"The support was bipartisan, and it was a win for patients and
physicians."

While differing in details, the Senate measure is similar to the House
bill in that they both would authorize creation of patient safety
organizations and establish a set of criteria by which they could be
credentialed. These groups would be responsible for collecting and
collating data on medical errors, as well as producing reports to help
institutions and physicians' practices correct systematic problems
that lead to those errors.

"The bill eliminates the shame-and-blame mentality and encourages
voluntary, confidential reporting for review by experts and feedback
so that the systems can be changed where the errors occurred," said
Dr. Palmisano. "The lessons learned can be shared in a de-identified
fashion so that everyone benefits."

Data collected by the patient safety organizations could be stripped
of personal information and sent on to federal agencies or other
organizations for analyses of nationwide trends.

It's important that patient safety organizations demonstrate a benefit
from the information they collect, said Henri R. Manasse Jr., PhD,
executive vice president and CEO of the American Society of Health
System Pharmacists.

Error reporting systems also have the potential to change the tone in
the medical liability system, he said.

Naturally, if reporting leads to fewer errors, that will reduce the
number of lawsuits against physicians, Dr. Palmisano said.
Voluntary and confidential

While the legislation does not make error reporting mandatory,
physicians and hospitals would have little to lose from submitting
reports to these groups because the documents would be kept
confidential.

But reporting error data to a patient safety organization would not
protect the original information from use in a lawsuit.

"Anyone who wants to make a claim against a physician or a hospital or
a nurse still has available all the usual means for discovery of
information," Dr. Palmisano said.

Currently, six states and several national groups already have some
experience with error reporting, but the federal legislation would
create a different system in distinct ways.

For example, states with patient safety laws mandate that hospitals
and other medical institutions report errors that lead to serious
patient injuries. Many states also make this information public.
Reporting laws passed more recently in some states are mandatory but
confidential.

Experts seem to agree that a voluntary system combined with strict
confidentiality of the information is the best way to encourage people
to report their mistakes.

Simply put, mandatory is not necessarily mandatory if people are
afraid to report information that can later be used against them, said
Paul M. Schyve, MD, senior vice president of the Joint Commission on
Accreditation of Healthcare Organizations.

"Because of the fear of disclosure that might then come back and hurt
them, organizations have been very hesitant to report this kind of
information, what goes wrong and why," he said. "The absence of this
kind of protection actually has slowed our country's ability to make
advances in the area of patient safety."

Although the federal reporting requirement would be voluntary, the
legislation does not call for preempting state laws, meaning reporting
of some events would still be mandatory in states with required
disclosure.
More data to mine

The state reporting systems also differ from the federal proposal in
that they collect information on only egregious errors -- what have
become known as "never events," shorthand for the contention that they
never should have happened.

The federal legislation calls for collecting a much larger pool of
data on minor errors and near misses that potentially could uncover a
multitude of systematic problems.

"Near misses, with just a little extra push here or there, could have
become one of these serious events and, as a result, you can learn
from the near misses," Dr. Schyve said. "Because near misses are much
more common than the actual bad event, you may actually have more data
to learn from when you're collecting the near misses."

Developing the local and national infrastructure needed to collect
these new data and turn them into useful information for physicians
and others will be a complex task. The patient safety organizations
will have to adhere to relatively strict credentialing requirements
but still could take many different forms, experts said.

While the groups might work on a regional basis to collect information
from local institutions, they also could work nationally,
concentrating on specific types of errors such as prescribing or
surgical mistakes.

Above these regional or specialty organizations, national groups could
use the de-identified data to create virtual databases that paint a
bigger picture of trends in medical errors.

The enormous potential for finding new and effective ways to reduce
medical errors is one of the reasons many people in the medical
community are so enthusiastic about passage of this legislation.

"It's a monumental accomplishment, and it opens the door to rapid
advancement in patient safety akin to the successful model of the
aviation reporting system," Dr. Palmisano said.

ADDITIONAL INFORMATION:
Weblink

Thomas, the federal legislative information service, for bill summary,
status and full text of the Patient Safety and Quality Improvement Act
(HR 663) (thomas.loc.gov)

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