Summer 2005
New Federal Patient Safety Law
The federal government took a cue from state legislators in Pennsylvania and elsewhere when George W. Bush signed into law the Patient Safety and Quality Improvement Act of 2005 on July 29, 2005. Very much like the MCARE Act that had been enacted in Pennsylvania in 2002, the Patient Safety and Quality Improvement Act is predicated upon, in part, the 1999 Institute of Medicine report focused upon hospital safety called "To Err is Human." Like the MCARE Act, the success of the federal law depends upon the health system industry and practitioners' acceptance of the culture of disclosure, whereby the lines of communication among hospital staff, the administration, and with patients, are open.
Under the federal law, physicians and other health care professionals are encouraged to report adverse events and/or near misses, much in the same fashion as they are now being required to do under Pennsylvania law. It is unclear at this point how the federal law is going to be implemented. It is possible that the Pennsylvania Department of Health, which currently administers the MCARE Act, will also be required to implement the federal act by providing certification of compliance for both.
There is some insulation from liability for physicians and other reporting health care professionals with respect to adverse events to foster sharing of information. For health care professionals, physicians and health care facilities, the new federal law is only one more legal construct with which they must comply.
Complying with the various statutes and regulations that pertain to health care professionals and facilities today is an enormous task, particularly when the Department of Health has indicated that it is now going to emphasize enforcement of MCARE with respect to its reporting obligations, and the sharing of information without the fear of retribution.
The responsibilities for reporting for physicians and health care professionals and health care facilities alike are largely the same as that which are already required by state law and the Joint Commission on Accreditation for health care facilities. However, these laws are created in order to foster a collegial discussion designed to reduce medical errors and human error in the health care area. Navigating through the various laws poses an arduous task with which attorneys familiar with multiple levels of health care compliance can offer valuable assistance.
Pennsylvania's Focus Upon Patient Safety
Programs to ensure compliance with the multitude of regulatory schemes, both federal and state, have become even more essential with the enactment of MCARE, the development of new acute facility regulations, and now federal reporting obligations created in the interest of patient safety.
With MCARE, the Pennsylvania Department of Health has been assisting with Pennsylvania's effort to focus upon patient safety matters, and reduction of medical errors. The general hospital regulations, currently Chapter 51 of the Pennsylvania Code, are being revised, with a roll-out date estimated in two years. The proposed regulations are expected to be published for official notice and comment in 2007. Health care facilities should be on the lookout for draft regulations to be posted in the next couple months for unofficial comments.
These long awaited regulations are needed more than ever, now that MCARE, enacted in 2002, has altered the reporting obligations and mechanisms for facilities, physicians and health care professionals. Under MCARE, health care professionals and physicians in a facility, as well as the facility itself, are required to report adverse events, "serious events" and/or near misses to varying degrees to either the Department of Health or the Patient Safety Authority to comply with the Act.
Health care facilities that are regulated by the Pennsylvania Department of Health need to be mindful of their reporting obligations since MCARE's enactment. Although new regulations are on the horizon, the Department of Health has increased its efforts to monitor and enforce MCARE, and compliance with its reporting requirements.
Internal EMTALA Screening Policies Set the Standards for Hospitals
EMTALA (Emergency Medical Treatment and Active Labor Act) has become a hotbed of compliance again as the courts interpret the obligations erected by the federal law. Federal courts have, for the most part, been disinclined to find EMTALA violations. However, a federal court of appeals opinion issued in July held that a hospital could be liable for failing to follow internal policies and procedures.
Hospitals must be prepared to comply with their policies and procedures drafted to comport with EMTALA obligations to avoid liability and penalties under the statute. As hospitals and their emergency staff are aware, EMTALA requires that each person who presents to an emergency department be screened and/or stabilized with appropriate medical treatment as deemed necessary based on the screening prior to discharge. The triage that is provided as part of the screening process administered by an emergency department must be performed in accordance with internal procedures, or the hospital may be the basis for liability for an EMTALA violation.
EMTALA creates a private right of action for persons harmed by its violation, such as through a failure to properly screen. The screening administered is designed to assess the treatment needs of an emergency department patient. If the screening is not administered in accordance with hospital policy, the hospital subjects itself to potential liability on a stabilization claim. The screening must be administered even-handedly, such that each patient is treated equally regardless of insurance coverage or ability to pay.
For more information about EMTALA obligations as interpreted by the courts, and compliance assistance with any of the above laws, contact the author Lucinda C. Glinn at lcglinn@nssh.com.
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