Wednesday, August 01, 2007

Donation Difficulties: the Case in San Luis Obispo

Those of us involved in supporting families when patients are dying, and sometimes through decisions regarding donation of organs and/or tissues of patients who have died, will be following the news closely. In San Luis Obispo, California, a transplant surgeon has been charged with dependent adult abuse, administering a harmful substance, and unlawful prescribing of sedatives. You can read news of the case here.

I have been involved in working with families considering donation for twenty years. I am trained by the local organ procurement organization to approach families about donation of tissues after a patient has died cardiac death (as distinct from brain death). I orient new nurses in my hospital to procedures at the time of death, and to working with the organ procurement organization. Therefore, I certainly have opinions of the facts as presented.

I will admit that my first question was whether this was another situation like that of Anna Pou, Lori Budo, and Cheri Landry in New Orleans. Were the facts ambiguous and arguable? Might this be a case of incrementally increasing pain medications for the right reasons – to relieve pain – that unfortunately ended when the patient died? It would certainly be possible for that to happen, and to be misunderstood by the grieving family, or regulators, or both.

However, the specific allegations of this case certainly rule out that possibility. Whether the physician is convicted, there are some definite concerns here regarding events.

Perhaps it would be best to begin with the process of seeking consent for organ and tissue donation. In all cases, the first step is assessment of the patient for severe brain injury. Broadly, we can identify three categories from the assessment: 1) the patient is brain dead, the brain so damaged that without the support of a mechanical ventilator (a “breathing machine”) all functions controlled by the nervous system would already have stopped; 2) the patient is so severely brain damaged that in best medical judgment the patient will not survive, but some basic functions like breathing could continue for a long time; or 3) the patient’s brain damage is less severe, and in best medical experience there is some possibility of recovery. Patients in category 1 may be eligible to donate solid organs, such as heart, liver, lungs, etc – our most common image of organ donation. Patients in category 2 may be eligible to “donate after cardiac death;” that is, it may be possible to recover kidneys if done quickly after breathing and heart function have been stopped long enough to verify death, usually five minutes. Patients in category 3 are not eligible to donate organs at all. (Any patient, whether on a ventilator or suffering brain damage or not, may be eligible after cardiac death – after the heart has stopped –to donate tissues – skin, long bone, heart valves, certain blood vessels, etc.)

In all cases of organ donation, whether in category 1 or 2, there is a point where there must be an independent judgment about the patient’s death. In category 1 that point is the diagnosis of brain death itself. Proper practice requires that the assessment of the extent of brain injury, the possibility of recovery, and the diagnosis that the patient is brain dead must be made without consideration of the patient’s eligibility to donate. Commonly, the diagnosis is made by a neurologist or neurosurgeon, or by a physician with expertise in intensive care, or by more than one such physician. The diagnosis is not properly made by a surgeon involved in transplant because of concern about conflicts of interest. Again, in proper practice that diagnosis is confirmed by appropriate medical tests, and the family is informed. Only after the family is informed that the patient is dead due to brain death is it appropriate to approach the family about the possibility of donation, unless family members bring it up themselves. (This last is also true of tissue donation: only after the patient has died and the family has had some period to accept this would it be appropriate to approach the family about donating tissues.)

In category 2, there is no diagnosis of brain death. Instead, there is a complete assessment of the brain injury and of the patient’s likelihood of recovery. The family is then informed by the physician that the possibility of the patient’s recovery is very poor. Families then face decisions of how aggressive to be in continuing support, and of what the patient would want regarding his or her own care. Some families – these days, perhaps most families – will decide that it is appropriate to stop medical intervention and allow natural death. For a patient who might be eligible for donation after cardiac death, this is the decision that must be fully independent. The family’s decision about continuing or withdrawing life support must be independent of any consideration of possibilities of donation. Again, only after they have been informed and have made their decision to withdraw care, and shared that decision with medical staff is it appropriate to approach the family about the possibility of donation, unless family members have raised the issue themselves.

To some extent, specific facts still need to be determined in court. In addition to the criminal case, there is a civil suit brought by the patient's mother against the physician, and also against the hospital, the system that owns the hospital, and the regional organ procurement organization. Many have begun to wonder what the consequences of these legal actions will be for efforts at organ and tissue donation both regionally and across the nation.

Of particular interest to me is that this has been investigated by the Center for Medicare and Medicaid Services (CMS). Institutions that receive funds through Medicare and/or Medicaid are required to follow federal regulations regarding organ and tissue donation, and compliance with those regulations is overseen by CMS. In addition, regional organ procurement organizations are subject to review by CMS and by the Health Resources and Services Administration (HRSA). An institution that isn't compliant can lose all Medicare and Medicaid reimbursement - for almost all institutions, a significant loss indeed. Usually, when there's a concern about compliant, it's because the institution hasn't been consistent enough in working with the organ procurement organization to be sure all patients who die are assessed for eligibility to donate, and that families of all eligible patients are approached to request donation. In this case, the concern would seem to be from the other pole: that some person or persons in this case were too proactive, and did not care for the patient and family appropriately. Direct involvement by CMS focuses high stakes for the institutions involved, and not just for one doctor.

At any given time in recent years, there have been between 75,000 and 80,000 persons on waiting lists who might benefit from organ donation. In recent years there have been between 20,000 and 25,000 organs donated. Today, according to the United Network for Organ Sharing (UNOS), an umbrella organization for regional organ procurement organizations, there are more than 98,000 currently on waiting lists, while through April of this year more than less than 10,000 transplants have occurred from less than 5,000 donors. Those discrepancies have for some time had the attention of Congress, and Congress has watched intently the work of CMS and UNOS in encouraging institutions and individuals to support donation. With all that attention, institutions are certainly concerned to comply with all regulations, and to cooperate with CMS and organ procurement organizations in identifying patients eligible to donate, and in properly approaching their families. If in individual or institution have been inappropriate in caring for a patient or in caring for a family in this process, the consequences could ripple through the nation's donation and transplant system. Many of us will be watching this case, knowing it could directly or indirectly affect what we do.


Anonymous said...

You must be the President of the OPTN! You got all the answers - huh? DCD is killing people. Go to WWW.MYFOXNY.COM and search - organ donation controversy. You know what's really going on - and so do I. May GOD give me strength.

Marshall said...

Anonymous, I wish you had idenitified yourself. I take your concern seriously.

I did look at the story available on line here. It appears to me that this was another case of procedures not being followed. It sounds like the family is appropriately seeking information and relief, and that appropriate authorities are investigating. I think judgment needs to await their discovery of facts. I'm not sure ambush journalism is helpful. I am also aware that there are federal requirements regardingprivacy of medical records that would prevent anyone, including the representative of CORE, from discussing the case under those circumstances.

No, I don't work for the local organ procurement organization, although I am responsible in our hospital for overseeing compliance with federal requirements, including policies and procedures regarding donation after cardiac death (DCD). I know that when a family makes the decision to withdraw support based on full information and their own values, and are approached after that about donation with appropriate sensitivity to their own values, DCD is not per se "killing people." There are those who believe that withdrawing support under any circumstances is inappropriate have a right to their opinion, but they're addressing a different point in the process.