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Pennsylvania State Senate
04/18/2024 11:42 PM
Pennsylvania State Senate
https://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=S&SPick=20210&cosponId=34311
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Senate of Pennsylvania
Session of 2021 - 2022 Regular Session

MEMORANDUM

Posted: January 21, 2021 04:48 PM
From: Senator John R. Gordner
To: All Senate members
Subject: Informed Consent under the MCare Act
 
I plan on reintroducing legislation that seeks a legislative remedy to address a Pennsylvania Supreme Court decision which significantly restricted a physician’s ability to delegate the duty to obtain the informed consent of a patient prior to specified procedures under the Medical Care Availability and Reduction of Error (MCare) Act.  Under section 504 of the MCare Act, a physician has a duty to obtain the informed consent of a patient or a patient’s authorized representative prior to conducting the following procedures:
 
(1) Performing surgery, including the related administration of anesthesia.
(2) Administering radiation or chemotherapy.
(3) Administering a blood transfusion.
(4) Inserting a surgical device or appliance.
(5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.
 
In June 2017, the Pennsylvania Supreme Court ruled, in a 4-3 decision in the case of Shinal v. Toms, 162 A.3d 429 (Pa. 2017), that physicians have a non-delegable duty under the MCare Act to obtain a patient’s informed consent.  Additionally, the Court ruled that communications between a physician’s qualified staff members and patients will no longer be admissible at trial to establish whether the physician obtained informed consent.
 
This ruling severely hampers the concept of team-based care and ignores the realities of present-day health care.  It further takes away a physician’s medical expertise and judgment in determining how best to serve his or her patients.  As Justice Max Baer’s dissent noted, “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.” 
 
My legislation will:
  • Clarify that while physicians remain responsible for the overall care of their patients, the task of obtaining a patient’s informed consent may be delegated by a physician to a “qualified practitioner.”
  • Allow health care facilities and physicians to develop policies and procedures regarding informed consent concerning when qualified practitioners other than physicians may obtain informed consent.
  • Allow physicians and other qualified practitioners to rely on information provided by another qualified practitioner to obtain the informed consent of the patient and allow this information to be used as evidence in a proceeding in which it is alleged that the physician or other qualified practitioner failed to obtain informed consent.
  • Clarify requirements in human research conducted pursuant to federal law and regulations related to informed consent.
  • Clarify when a physician or qualified staff person is required to obtain a separate or new informed consent from a patient when informed consent was already obtained.
This legislation is supported by the Pennsylvania Medical Society (PAMED) and The Hospital and Healthsystem Association of Pennsylvania (HAP).
 
While physicians should be held to very high standards, we must provide them with the ability to determine when to employ the assistance of other qualified practitioners within a framework that still ensures patients are protected and have access to information they need to make informed decisions about very important health care matters.
 
This legislation was introduced in the 2019-2020 session as Senate Bill 761.
 
Thank you for your consideration and please feel free to contact my office if you have any questions regarding this proposed legislation. 
 


Introduced as SB425