Three Fully Licensed Elective Angioplasty Hospitals Fight to Preserve Patient Safety Rules
Cooper University Hospital, Deborah Heart and Lung Center and Our Lady of Lourdes Medical Center today announced an effort to preserve patient safety rules that require hospitals performing elective angioplasty to be licensed and capable of performing onsite open-heart surgery in case complications call for prompt, aggressive treatment.
Proposals to weaken the rules will be introduced at the Health Care Advisory Board on July 19. NJ Department of Health Commissioner Fred Jacobs has proposed changes to the safety rules so hospitals without onsite cardiac surgical capability can participate in a clinical experiment.
“Eighteen hospitals across the state are already fully licensed to perform elective angioplasty as well as open heart surgery to provide the ‘safety net’ mandated by the New Jersey Department of Health and Senior Services,” said Dr. Jan Weber, Chief, Division of Cardiology Our Lady of Lourdes Medical Center. “There certainly is no need to expand elective angioplasty service to hospitals that are not qualified under existing safety regulations. New Jersey’s existing safety regulations are supported by clinical guidelines of the American Heart Association, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions.”
“If New Jersey weakens its safety regulations, patient safety will suffer. Existing studies have shown that angioplasty-related deaths increase 38 percent when elective angioplasty is performed at a center without onsite cardiac surgical backup,” said Dr. Joseph Parrillo, Director, Cooper Heart Institute, Cardiovascular and Critical Care Services, Cooper University Hospital.
The campaign will challenge the safety of the elective angioplasty experiment and question whether patients are being properly informed that the experiment violates clinical guidelines. Informational advertisements on the experiment’s risks will appear in newspapers around the state. (Editors: A copy of the advertisement is attached.)
In a case brought by the three hospitals, the New Jersey Supreme Court ruled May 31, 2007 that the NJ Department of Health and Senior Services ignored its own safety rules and regulatory procedures when it allowed nine hospitals to participate in the experiment. None of the nine hospitals perform open-heart surgery, which is required by state regulations in order to protect patients.
If the new rules are not approved, unqualified New Jersey hospitals will stop performing elective angioplasty on November 30, 2007.
Questions on Elective Angioplasty Experiment
Q. What is elective angioplasty?
A. Elective angioplasty involves a scheduled procedure to insert a catheter into the patient’s arteries and use a stent or balloon to clear blockages that may be impeding blood flow to the heart.
Q. How did the Supreme Court get into this issue and what did it rule?
A. The New Jersey Department of Health and Senior Services authorized nine hospitals to participate in an experiment to test whether elective angioplasty should be performed in hospitals without onsite surgical capability. Citing “concerns for the process and for patient well-being,” the Court ruled the project be stopped unless New Jersey decides to change its current patient safety regulations to create an exception that would allow the experiment to proceed.
Q. What is the role of the Health Care Administration Board?
A. The Board has the statutory duty to advise the Commissioner of Health on health care policy and it reviews regulations that the Commissioner wishes to propose. The Supreme Court found that the Commissioner ignored the safety protections built into the regulatory process by bypassing the Board on this issue. With the new rule proposed by the Commissioner, the Board will consider the issue for the first time on July 19.
Q. Is this an issue of patient convenience? Without this experiment, will segments of the state’s population be denied access to elective angioplasty?
A. Eighteen hospitals in New Jersey currently perform elective angioplasty with on-site surgical backup. Each has undergone a vigorous review and is properly licensed by the New Jersey State Department of Health and Senior Services to perform cardiac surgery and elective angioplasty. There is more than enough capacity at these hospitals to meet patient demand for this procedure. Everyone in New Jersey lives within close proximity to one or more of these hospitals, so access is not an issue.
Q. Isn’t this just an economically driven issue being fought between hospitals competing for market share?
A. No, it is an issue of patient safety. While some hospitals may have an economic motivation for wanting to enter the elective angioplasty field, New Jersey’s patient safety regulations require that they must have onsite cardiac surgical facilities to do so. These requirements should not be cast aside for this experiment.