§ 2800.30. Informed consent process.

 (a)  Initiation of process.

   (1)  When a licensee determines that a competent resident’s decision, behavior or action creates a dangerous situation and places the competent resident, other residents or staff members at risk of harm by the competent resident’s wish to exercise independence in directing the manner in which the competent resident receives care, the licensee may initiate an informed consent process to address the identified risk and to reach a mutually agreed-upon plan of action with the competent resident or the resident’s designated person. The initiation of an informed consent process does not guarantee that an informed consent agreement, which is agreeable to all parties, will be reached and executed.

   (2)  When a competent resident wishes to exercise independence in directing the manner in which the competent resident receives care, the competent resident may initiate an informed consent process to modify the support plan and attempt to reach a mutually agreed upon plan of action with the licensee.

   (3)  An incompetent resident shall be eligible for an informed consent agreement only if the resident’s legal representative is included in the negotiation of the informed consent agreement and executes the agreement.

 (b)  Notification.

   (1)  When the licensee chooses to initiate an informed consent process, the provider shall do so by notifying the competent resident and, if applicable, the resident’s designated person in writing and orally. The notification must include the contact information for the ombudsman. For incompetent residents, the ombudsman shall be automatically notified by the licensee. Notification shall be documented in the resident’s file by the licensee.

   (2)  When a competent resident chooses to initiate an informed consent negotiation, the competent resident shall do so by notifying the licensee in writing and orally. Notification shall be documented in the competent resident’s file by the licensee. When a legal representative for an incompetent resident chooses to initiate an informed consent negotiation, the legal representative shall do so by notifying the licensee in writing or orally. Notification shall be documented in the incompetent resident’s file by the licensee.

 (c)  Resident’s involvement. A resident who is not incompetent shall be entitled, but is not required, to involve his legal representative and physician, and any other individual the competent resident wants involved, to participate or assist in the discussion of the competent resident’s wish to exercise independence and, if necessary, in developing a satisfactory informed consent agreement that balances the competent resident’s choices and capabilities with the possibility that the choices will place the resident, other residents or staff members at risk of harm.

 (d)  Informed consent meeting.

   (1)  In a manner the competent resident can understand, the licensee shall discuss the competent resident’s wish to exercise independence in directing the manner in which he receives care. The discussion must relate to the decision, behavior or action that places the competent resident, other residents or staff members at risk of harm and hazards inherent in the resident’s action. The discussion must include reasonable alternatives, if any, for mitigating the risk, the significant benefits and disadvantages of each alternative and the most likely outcome of each alternative. In the case of an incompetent resident, the incompetent resident’s legal representative shall participate in the discussion.

   (2)  A resident may not have the right to place other residents or staff members at risk, but, consistent with statutory and regulatory requirements, may elect to proceed with a decision, behavior or action affecting only his own safety or health status, foregoing alternatives for mitigating the risk, after consideration of the benefits and disadvantages of the alternatives including his wish to exercise independence in directing the manner in which he receives care. The licensee shall evaluate whether the competent resident understands and appreciates the nature and consequences of the risk, including the significant benefits and disadvantages of each alternative considered, and then shall further ascertain whether the competent resident is consenting to accept or mitigate the risk with full knowledge and forethought.

 (e)  Successful negotiation. If the parties agree, the informed consent agreement shall be reduced to writing and signed by all parties, including all individuals engaged in the negotiation at the request of the competent resident, and shall be retained in the resident’s file as part of the service plan.

 (f)  Unsuccessful negotiation. If the parties do not agree, the licensee shall notify the resident, the resident’s legal representative and the individuals engaged in the informed consent negotiation at the request of the resident. The residence shall include contact information on the local ombudsman or the appropriate advocacy organization and whether the licensee will issue a notice of discharge.

 (g)  Freedom from duress. An informed consent agreement must be voluntary and free of force, fraud, deceit, duress, coercion or undue influence, provided that a licensee retains the right to issue a notice of involuntary discharge in the event a resident’s decision, behavior or action creates a dangerous situation and places other residents or staff members at risk of harm and, after a discussion of the risk, the resident declines alternatives to mitigate the risk.

 (h)  Individualized nature. An informed consent agreement must be unique to the resident’s situation and his wish to exercise independence in directing the manner in which he receives care. The informed consent agreement shall be utilized only when a resident’s decision, behavior or action creates a situation and places the resident, other residents or staff members at risk of harm. A licensee may not require execution of an informed consent agreement as a standard condition of admission.

 (i)  Liability. Execution of an informed consent agreement does not constitute a waiver of liability beyond the scope of the agreement or with respect to acts of negligence, tort, products defect, breach of fiduciary duty, contract violation, or any other claim or cause of action. An informed consent agreement does not relieve a licensee of liability for violation of statutory or regulatory requirements promulgated under this chapter nor does it affect the enforceability of regulatory provisions including those provisions governing admission or discharge or the permissible level of care in an assisted living residence.

 (j)  Change in resident’s condition. An informed consent agreement must be updated following a significant change in the resident’s condition that affects the risk potential to the resident, other residents or staff members.

 (k)  Either party has a right to rescind the informed consent agreement within 30 days of execution of the agreement.

Cross References

   This section cited in 55 Pa. Code Appendix A (relating to assisted living resident rights: during residency and during discharge or termination of residency).



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