Good afternoon, everyone. Thank you for inviting us to speak. My colleague Jan Emerton, president-elect of the Canadian Association of Transplantation, is here with me.
Thank you for asking us to speak in request to the exclusionary criteria of the Canadian general standards that are appended to the Health Canada regulations on the safety of cells, tissues, and organs. The Canadian Association of Transplantation, or CAT, as we're known, has represented health care professions in the donation and transplant field for 21 years. Over the years CAT members have participated on steering committees and subsequent advisory committees for the development of these standards.
The purpose of these regulations is to minimize the potential health risk to recipients of cells, tissues, and organs. The most important component of the organ donation process is that of the donor assessment. This provides the information required for decisions regarding acceptance or exclusion of organs for the purpose of transplant.
The following presentation will outline two of the main aspects of the assessment, which include organ function and risk assessment, both of which are required in order for a transplant physician to arrive at an acceptance or exclusion decision.
The organ function component involves a review of past and current laboratory investigations to determine organ-specific function as well as additional direct and indirect testing, which may include x-ray studies, electrocardiograms, echocardiograms, bronchoscopies, cardiac catheterizations, and diagnostic imaging procedures.
The potential donor's past medical history is also reviewed to identify if specific diseases exist that may directly or indirectly impair the organ function. Examples of this would include hypertension, high cholesterol, diabetes, chronic pulmonary lung diseases, or cancer.
The risk assessment utilizes two primary tools to identify any potential for disease transmission. First, serological or blood testing is conducted to determine the presence of infectious disease such as hepatitis B, hepatitis C, human T cell lymphotropic virus types I or II, Epstein Barr virus, cytomegalovirus, or human immunodeficiency virus--HIV--the virus that causes AIDS.
In addition to serological testing, a medical-social history interview is also conducted to identify risk factors. A number of questions are asked, ranging from past hospital visits to recent travel and social behaviours. For example, recent travel to warm climates may indicate a higher risk for West Nile virus. Some social activities have been identified to statistically increase the risk potential for hepatitis B and C and HIV, initially identified by the Centres for Disease Control in a 1994 document.
These activities have become standard screening tools for the American Association of Tissue Banks, the Eye Bank Association of America, and most recently, the Canadian Standards Association in 2003. However, we have been using a screening process since 1996.
The medical-social history is conducted only by trained coordinators in a private setting. The history is reviewed with the potential donor's next of kin, significant life partner, or other appropriate individuals, utilizing a standardized history questionnaire. A medical and social history interview is conducted with sensitivity, discretion, and respect. The purpose of the interview is explained with a brief description of the types of questions that will be asked of these folks. This process allows the presumed historian the opportunity to decide if he or she is the best historian for these types of questions or if another person should be included.
The interview may take place in person or over the phone. The interviewer should indicate that due to the personal nature of the questions, only those individuals who are providing information should be present. The family is welcome to request that others remain in the room. However, it is helpful for the interviewer to request extra individuals leave the room to save the historian potential discomfort.
The interviewer is familiar with the medical-social history questionnaire and always asks questions in a sensitive manner. When given an affirmative answer, the interviewer strives to obtain as much information as possible about the answer. This may include direct quotations from the historian. The interviewer is always aware of non-verbal cues such as looking away, coughing, and fidgeting, which may indicate that a historian is being less than forthcoming, or that another person present has additional information that he is uncomfortable sharing with the group at this time.
In some cases, it may be helpful to ask the historian to recommend another individual who might be able to provide more information to the coordinator. A typical example would be a young adult donor; parents would be providing the medical history, and friends or siblings would be providing the social component to the history.
In addition, the final question for any medical and social history asks the interviewee to consider the donor's behavioural risk factors, and if there is any reason why organ and tissue donation should not proceed. No explanation is necessary from the interviewee. The intent of this question is to allow the next of kin, the significant life partner, or others the opportunity to stop the donation process when they are hesitant to disclose sensitive information regarding the donor.
If the answer is yes and the interviewee does not wish to give more specific information, the donor will be deferred. But again, organs may be used and deemed acceptable by the transplanting physician, when the risk of not receiving an organ is greater than that of disease transmission, through the use of exceptional distribution that includes the informed and verified consent of the recipient.
In summary, I would like to say that the Canadian Association of Transplantation has supported the development of the Health Canada regulations over the past decade. Our primary concern is that of maximizing safety and minimizing risk to the transplant recipients. We feel that the regulations do not discriminate against any individual wishing to donate organs, but instead ensure full assessment of potential donors that better enable transplant physicians to make risk-benefit decisions.
Thank you for allowing CAT to participate in this meeting today.