October 17, 2013
John Roberts, M.D.
Board of Directors
Organ Procurement and Transplantation Network/United Network on Organ Sharing
700 North 4th Street
Richmond, VA 23218
Dear Dr. Roberts:
Thank you for the opportunity to comment on the revised Requirements for Controlled Donation after Circulatory Death (DCD) Protocols (“Requirements”) provided by Mr. Richard Pietroski, Chair of the OPTN Organ Procurement Organization Committee. I am submitting the comments below on behalf of Not Dead Yet in the hope that they will be considered by the OPTN Ethics Committee next week, as well as the Board of Directors at its November meeting.
These comments are a follow up to five previous letters concerning the Donation after Cardiac/Circulatory Death protocols and Bylaws rewrites, dated January 3, June 14 and August 28, 2012, and June 19 and September 9, 2013, copies of which are attached for reference.
Our previous letters emphasize the importance of ensuring that individuals and families are able to make informed decisions about the withdrawal of life sustaining treatment prior to and independent from any contacts from organ procurement organizations (OPOs) or related organ procurement activities. We are concerned that organ procurement activities may unfairly and wrongfully tip the scales in health care decision-making at a vulnerable time by conveying the message that someone’s organs are more valuable to others, and to society, than his or her continued life with significant disabilities. I urge you to review our previous letters for a complete discussion of those issues.
The Introduction to Section 2.8’s Requirements continues to state:
Potential DCD donors are limited to patients whose medical treatment no longer offers a medical benefit as determined by the patient’s primary healthcare provider and in consideration of any available advanced directive executed by the patient.
This provision is objectionable and inconsistent with principles of patient autonomy because it allows the primary healthcare provider to determine whether medical treatment offers a benefit, not the patient or healthcare proxy, and only “in consideration” of an advance directive. In the majority of states, which have “futile care” statutes allowing doctors to overrule patients who desire life-sustaining treatment, a futile care decision by a doctor would make the patient a potential DCD donor under the proposed policy. We sincerely hope that this is not OPTN’s intent, but is an unintended consequence that requires further revisions to the language.
With respect to the timing of organ procurement discussions, the proposed Requirements state:
The timing of a potential DCD donor evaluation and donation discussion shall be coordinated with the OPO and the patient’s healthcare team, in accordance with hospital policy. Although the donation discussion should ideally occur after the decision to withdraw life-sustaining measures, the patient’s healthcare team and the OPO must collaboratively develop a communication plan, with consideration for first person authorization laws and advanced directives, to determine on a case-by-case basis the most appropriate time to engage the legal next of kin in the donation discussions or to allow for family-initiated discussions regarding organ donation.
While we appreciate the acknowledgement that “the donation discussion should ideally occur after the decision to withdraw life-sustaining measures”, this admission falls far short of a “Requirement” and is virtually meaningless as guidance for hospital or OPO activity.
The Requirements should be viewed as akin to regulations, developed by OPTN but subject to approval by the U.S. Dept. of Health and Human Services. To be effective, like regulations, the Requirements must be clear and specific, and there must be consequences for failure to comply with them. Even then, enforcement can be difficult in the face of competing interests. Unfortunately, the proposed Requirement is not clear, specific or enforceable, making it insufficient and unacceptable.
The Introduction also states, “DCD protocols should continue to be developed through collaboration between OPOs, transplants centers, and donor hospitals.” By deferring to individual OPOs, transplant centers and hospitals on such crucial issues, this proposal suggests that there is no scientific research to guide the formation of a uniform public policy governing organ procurement. Yet the Institute of Medicine has repeatedly made recommendations consistent with our position on the timing issue. OPTN/UNOS should be providing leadership in protecting patient autonomy rather than abdicating its responsibility to establish clear Requirements that protect both individuals and the integrity of the transplant system.
A final issue that we would like to address in this comment is raised by Section 2.8 D, which provides:
Conditions involving a potential DCD donor being medically treated/supported in a conscious mental state shall require that the OPO confirms that the healthcare team has assessed the patient’s competency and capacity to make withdrawal/support and other medical decisions.
This provision obviously pertains to conscious people on ventilators, people with disabilities, whether their conditions are life-long and chronic, such as neuromuscular disabilities, or acquired, such as spinal cord injury or brain injury. For members of Not Dead Yet and our allies among national disability rights organizations run by people with disabilities, these issues are often deeply personal. Many of us know people who wanted to die when they first became disabled, but later changed their minds and are grateful to be alive. Society’s biases against disability are overwhelming, and are at least as prevalent in the medical profession as in society at large, if not more so. More essential than “competency and capacity” as these have been defined in the medical world, the real issue is informed consent. We would ask, how could the healthcare team, ignorant as they are about living with a technology-dependent disability, possibly make a valid determination, in isolation from the disability community, of whether there is informed consent to withdraw life support? Add to medical ignorance about disability the mission of the OPO to procure organs, and we see the makings of a perfect storm that poses a direct threat to the lives of people with disabilities. In the face of this direct threat, our concerns continue to be marginalized rather than substantively addressed.
We urge both the Ethics Committee and the OPTN Board to refrain from acting on the pending proposals before you have carried out your duty to protect the interests of potential organ donors as well as safeguard public trust in the integrity of the organ procurement and transplantation system.
Please contact me with any questions you may have and, above all, create a system that all of us can trust to value our lives. Thank you for your time and attention.
Diane Coleman, JD