protocol content represent differences in considered judgment about how to put these standards into practice.
Roundtable participants provided their protocols for discussion, and for inclusion in this report (Appendix F). Table 4-1 summarizes the content of these protocols in relation to four specific recommendations from the 1997 IOM report.
There are minor local variations in protocol provisions for medications and for family options during the withdrawal of support. These variations are based on the preferences and practices of hospitals, OPOs, and organ recovery and transplant surgeons.
There is substantial consensus on obtaining patient or family consent for premortem cannulation. There is one exception in this area. When a patient has died following failed resuscitation efforts, Washington Hospital Center places cannulae and begins in situ organ preservation to keep the option of donation open until the family can be contacted. This intervention for uncontrolled non-heart-beating donation was developed through a program of community outreach and oversight and is permitted by local legislation.
There is substantial consensus on allowing a five-minute interval to elapse between the cessation of cardiopulmonary function and the start of organ recovery. There are variations in the way this interval is specified in the protocols. The declaration of death always precedes organ recovery. If the declaring physician incorporates the five minute interval into the declaration of death, organ recovery follows immediately. If not, the organ recovery team waits five minutes after the declaration of death before proceeding with recovery.
The University of Pittsburgh declares death and begins organ recovery after two minutes of pulselessness, apnea, and unresponsiveness (Appendix F). This center finds the empirical data on autoresuscitation adequate to support a two-minute interval. This variation is based on considered judgment about clinically and ethically acceptable practice and on expert interpretation of the available data.
These variations suggest that even with a strong commitment to ethical practice and a reliance on the best clinical data available, there is room for significant differences of opinion on non-heart-beating donation practices.
Workshop participants recognized the value of consistency in key areas to avoid confusion and to maintain public, provider, and family trust in the donation system. The committee concurred with the 1997 IOM report in recommending that a five minute interval be allowed to elapse between the cessation of cardiopulmonary function and the declaration of death. However, full consensus was not achieved at the workshop. This is an area in which well-considered judgments continue to differ. As such, it is a decision point at which different options may be followed, but the grounds for selecting one option over another should be clearly specified.