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Vice President of Healthcare Risk Services
Tom Snyder x5852

Manager, Healthcare Risk Services
Phyllis DeCola x5897

What Must The Patient Be Told After An Adverse Event?
Page 3

Can a doctor be sued for lack of informed consent for post –surgical discussions?

Yes. The Liguori case described above involved a patient family’s claim that following a surgical mishap the attending surgeon failed to provide them with information which would have been “material” to a reasonable person in deciding whether to permit the defendant doctors and hospital to continue to care for their mother. They claimed the right of “self determination” enjoyed by every patient was violated by the attending surgeon, and that if they had been told the true cause and extent of their mother’s injury they would have transferred her from an “unsafe environment” in time to prevent complications including a deep, infected bedsore which caused her death due to sepsis. The jury accepted the doctor’s account of his post-operative conversation with the patient’s family. However, had the jury found for the plaintiffs they would have been permitted to enter an award against the doctor for part of the injuries suffered and the alleged wrongful death of the patient. This would likely have been paid by the doctor’s malpractice insurance company, along with the cost of the doctor’s defense, but would also have resulted in a substantial increase in the doctor’s malpractice premium, or perhaps even cancellation.

 

What is the Patient Safety Act and how does it apply to adverse events?

Purpose- In April 2004 the New Jersey Legislature enacted the Patient Safety Act, in response to their finding that “health care literature demonstrates that the great majority of medical errors result from system problems, not individual incompetence” and that preventable errors were “inherent in all systems”. The Legislature’s goal was to create a system that would allow for the detection and analysis of medical errors while creating a “non-punitive culture that focuses on improving health care, not assigning blame.” While finding that health care facilities and professionals must be held accountable for “serious preventable adverse events” the Legislature also recognized that “punitive environments … may be a deterrent to the exchange of information required to reduce the opportunity for errors to occur in the complex systems of health care delivery.”[12]

 

Therefore by mandating the “confidential disclosure of the most serious, preventable adverse events” and also encouraging the “voluntary, anonymous and confidential disclosure of less serious adverse events, as well as preventable events and near misses the State seeks to increase the amount of information on system failures, analyze the sources of these failures and disseminate information on effective practices for reducing system failures and improving the safety of patients.”[13] Annual summaries are issued by the Dept. of Health and Senior Services.

 

Patient Safety Plan-The Act requires health care facilities to create a “patient safety plan” which includes the formation of a committee and teams of facility staff, “comprised of personnel who are representative of the facility’s various disciplines” and who are competent “to conduct analysis and application of evidence based patient safety practices in order to reduce the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures, and … to conduct analyses of near-misses, with particular attention to serious preventable adverse events and adverse events.”[14] The law requires health care facilities to report “every serious preventable adverse event that occurs in that facility” to the N.J. Dept. of Health and Senior Services and to assure that the patient is informed.[15] The law also requires the health care facility to create a process for ongoing patient safety training for facility personnel.

 

Definitions- An event means a “discrete, auditable and clearly defined occurrence”. A near miss is an “occurrence that could have resulted in an adverse event but the adverse event was prevented.” An adverse event is “an event that is a negative consequence of care that results in unintended injury or illness, which may or may not have been preventable”. A preventable event is “an event that could have been anticipated and prepared against but occurs because of an error or other system failure.” A serious preventable adverse event is defined as “an adverse event that is a preventable event and results in death or loss of a body part, or disability or loss of bodily function lasting more than seven days or still present at the time of discharge from the health care facility.” Health care facility is one licensed by the State of New Jersey.[16]



[12]   N.J.S.A. 26:2H-12.24.

 

[13]   Ibid.

 

[14]   Ibid. 12.25(b).

 

[15]   Ibid. 12.25 (c), (d).

 

[16]   Ibid. 12.25 (a).

 

Adverse Events, page 4  

  

 

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