This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Discuss the 2017 ruling by the Supreme Court of Pennsylvania regarding whether a physician can delegate informed consent
2. List which features constitute informed consent
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
Faculty: Susan J. Gross, MD, receives consulting fees from Genoox, Inc., and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Dec 31 2017 through Dec 31 2019, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
In June 2017, the Supreme Court of Pennsylvania determined that “A physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient’s informed consent. Informed consent requires direct communication between physician and patient, and contemplates a back-and-forth, face-to-face exchange, which might include questions that the patient feels the physician must answer personally before the patient feels informed and becomes willing to consent” (emphasis added).
This shocking decision now requires physicians across the Commonwealth of Pennsylvania to change their practice for obtaining informed consent from patients. Physicians now must personally obtain informed consent as well as personally answer their patients’ questions. Physician assistants, nurses, and other medical personnel can no longer obtain informed consent.
As the dissenting opinion stated, “Today’s decision will have a far-reaching, negative impact on the manner in which physicians serve their patients. For fear of legal liability, physicians now must be involved with every aspect of informing their patients’ consent, thus delaying seriously ill patients access to physicians and the critical services that they provide.”
This landmark decision arose from a medical malpractice lawsuit where the patient alleged that the operating neurosurgeon failed to explain the risks of the surgery for a recurrent non-malignant tumor in the pituitary region of her brain or to offer her the lower risk surgical alternative of subtotal resection of the benign tumor, followed by radiation. During the surgery, the patient’s carotid artery was perforated, resulting in hemorrhage, stroke, brain injury, and partial blindness. The patient met once with the neurosurgeon but had her questions about the surgery answered on two separate visits by a physician assistant. In 2002, Pennsylvania enacted the Medical Care Availability and Reduction of Error Fund (“MCARE”) Act. This Act plainly states that that “a physician owes a duty to a patient to obtain informed consent[.]” Therefore, the trial jury could not consider in its deliberations whether the information was given to the patient by the physician assistant. The jury had returned a verdict in favor the neurosurgeon. With this June 2017 ruling, the case must undergo a new trial.
The process of informed consent will depend upon the jurisdiction in which you practice. A review of your informed consent process is warranted even if you do not practice in Pennsylvania.
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This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.