August 08, 2017
TO: Chief Executive Officers, Chief Medical Officers, Chief Nursing Officers, Compliance Officers, and Governmental Relations Officers of HAP Member Hospitals and Health Systems
FROM: Jennifer Jordan, Vice President, Regulatory Advocacy Hospital and Healthsystem Association of Pennsylvania
SUBJECT: Pennsylvania Department of Health Rescinds Past Guidance regarding Obtaining Informed Consent
Issue: On July 31, 2017, the Pennsylvania Department of Health (DOH) rescinded its November 6, 2012, guidance related to obtaining consent for Peripherally Inserted Central Catheter (PICC) Line insertion and blood transfusions.
Member Action: HAP recommends that members take note of this development and evaluate their informed consent processes. We recommend that members take the following actions:
- Review your current policies, procedures, medical staff bylaws and privileges related to obtaining informed consent
- Consult your legal counsel to ensure that your practices align with your organization’s assessment of the current common law and statutory requirements
- Alert HAP if DOH surveyors or accreditation organizations surveying to DOH standards flag or cite “informed consent” issues during the course of a licensure survey or complaint investigation
DOH Message Board Post: On July 31, 2017, DOH posted the following message on its facility message board:
“The Pennsylvania Department of Health is rescinding in its entirety the guidance dated November 6, 2012 regarding PICC Lines, and on administering and obtaining consent for blood transfusions. To the extent the guidance conflicts with the June 20, 2017 ruling of the Pennsylvania Supreme Court in Shinal v. Toms, it is no longer valid.”
Upon reading the message board post, HAP reached out to DOH staff to learn whether or not the message board post indicates a change in DOH’s enforcement related to informed consent. In a verbal conversation on August 1, 2017, DOH staff took the position that the July 31 post does not mark a change in the department’s enforcement approach related to informed consent. DOH stated that surveyors will continue to look for signed consent forms and confirm that hospitals have (and follow) policies for obtaining informed consent consistent with MCARE Act.
DOH staff indicated that, at this time, DOH does not intend to provide formal guidance related to the Shinal v Toms decision.
Shinal v. Toms: In its June 20 ruling regarding Shinal v. Toms, the Pennsylvania Supreme Court held 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. The Court stated that informed consent requires direct communication between the 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.
Please see HAP’s June 30 Bulletin for more information about the ruling.
HAP Next Steps: HAP will continue to monitor for any emerging developments related to the Shinal v Toms and advocate on behalf of our members.
- HAP will continue to monitor Professional Licensure Boards to alert members about any potential practice impact. We meet regularly with DOH’s Division of Acute and Ambulatory Care (DAAC) leadership and will keep you informed if DAAC plans to adjust their enforcement approach.
- HAP is actively investigating legislative options to remedy the resulting operational burden. We are engaging members to shape our legislative advocacy strategy. HAP is convening a joint meeting of its Physician Leadership Advisory Group and Committee on Quality and Care Management members, today, August 3 at 12 p.m. to discuss the practical implication of the decision and solicit input necessary to shape our legislative strategy. We will alert members to future opportunities to provide feedback and input.
- HAP is engaging other provider stakeholders including The Pennsylvania Medical Society, Pennsylvania Society of Physician Assistants, and Pennsylvania Coalition of Nurse Practitioners to identify ways that we can coordinate our efforts to clarify and modernize the statutory landscape.