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【社会人文】医与法:不良事件的保密制度

Law and medicine: Adverse event confidentiality
December 18, 2008

By Miles J. Zaremski, J.D.
Imagine being a medical specialist who has been involved in an adverse event--one that, through no real fault of your own, caused death or serious injury to a patient. Should your future patients have a right to know of your involvement?

That is the issue Florida physicians are dealing with in the wake of a recent decision by the Florida Supreme Court earlier this year. The case was known as Florida Hospital Waterman, Inc. etc.,vs. Teresa M. Buster, etc., et al (No. SC06-912).

In November 2004, Florida voters passed a state constitutional amendment titled “Patients’ Right to Know About Adverse Medical Incidents.” The amendment allowed patients to obtain “any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident” - as long as the identity of the patients involved in the incidents wasn’t revealed, and other privacy restrictions were adhered to. This included incidents that had to be reported to a government agency, or those that were reported to health care facility review committees. The amendment was to become effective immediately.

About 6 months later, in June 2005, the Florida legislature attempted to clarify the amendment legislatively, stating that existing restrictions on use of records in court cases stay in place and that “discovering such documents does not mean that any of them can be introduced into evidence in a lawsuit ... and [they] may not be used for any purpose, including impeachment, in any civil or administrative action against a health care facility or health care provider.”

Because of the legislature’s action, two lower courts in Florida were asked to decide whether the amendment passed by the voters was retroactive - that is, did it apply to records that existed before the amendment was passed? One court held the amendment was retroactive; the other did not. The Florida Supreme Court, in a 4-3 decision (with a sharply worded dissent), found that the amendment was indeed retroactive. The court also found that several subsections of new law were in conflict with the amendment passed by the voters, and were therefore unconstitutional.

The Florida high court noted that access to peer review information is not to be limited to only those who are themselves patients since that restriction is not contained within the amendment. But more importantly, the court also said that because part of the new law allows current laws restricting access to adverse incidents to remain in place, the new law is in conflict with the amendment passed by the voters and therefore “cannot stand.”

The dissenting justices argued that the amendment should not be applied retroactively. They noted that hospitals are required to perform peer review as part of medical quality assurance, and that the hospitals should be able to keep peer review records from being used in legal cases. Now that the majority has found the amendment to be retroactive, the dissenters pointed out, that allows for the discovery of records previously kept confidential, a consequence that is “legally unsupportable” and “fundamentally unfair”.

The Florida Supreme Court goofed. In its fervor to address the issue of retroactivity, it created more of a problem than it should have. The majority eviscerates what has become the linchpin for a health care facility’s ability to ensure quality of care: its peer review function.

For example, let’s take a situation in which a hospital’s peer review committee obtains documents relating to an adverse medical incident. From those documents, the peer review committee makes a decision about the care rendered by a particular doctor.

Before the Florida Hospital Waterman case came down, there was an expectation that documents considered by a peer review committee would be privileged from discovery and not admissible in a legal proceeding. With Florida HospitalWaterman, no longer would such documents be cloaked with the protections against discovery provided in Florida. This would be inconsistent with protections against discovery provided in most - if not all - states having peer review statutes.

And, again, according to Florida Hospital Waterman, the right to see such evidence can pertain to documents that existed as of the date the Florida voters passed the constitutional amendment. How far back can the documents go? The court never says.

Another problem is that, for example, an accrediting organization such as the Joint Commission--which credentials a considerable portion of our nation’s hospitals and other health care facilities--may find some difficulty with the Florida Waterman’s majority’s decision. One area the Joint Commission looks at in its accreditation process are “sentinel events”--those involving deaths or serious injuries. What if a sentinel event is intertwined with an adverse medical incident? All such information would be usable in legal cases under Florida Hospital Waterman, which may make hospital administrators uncomfortable if the commission asks them to produce sentinel event information during an accreditation or reaccreditation process.

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作者:admin@医学,生命科学    2011-06-27 17:44
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