Hospital Initiatives


Setting up a multi-organ transplantation programme
– the prerequisites and the pitfalls

Setting up a multi-organ transplantation programme in any clinical facility is a massive endeavour and is made even more so when supporting social structures and legislation are not in place. Abrar Khan, MD, MS, MPhil, FACS, well experienced in setting up organ transplantation programmes, goes behind the scenes to look at the requirements and difficulties of establishing such a programme.

Starting a multi-organ transplantation programme is arguably the most difficult of medical programmes to initiate, not only because it requires highly skilled surgeons and physicians and is resource intensive (technical requirements), but also because its success depends upon the prevailing legislative, social, cultural, and religious environments (non-technical requirements).

In different regions of the world technical and non-technical obstacles assume different magnitudes. For example, in the United States the law accepts the concept of brain death, where a person is declared dead because his entire brain has been injured beyond recovery and has no function whatsoever. Also in the US, people mostly accept the concept of donating their loved ones’ organs upon death. In this setting, establishing only the technical infrastructure is the major challenge.

On the other hand, in the UAE, for example, death is defined as complete cessation of the heart and respiratory system and brain death is not clearly stated as being one of the definitions of death. In fact, until now, there wasn’t much incentive to codify such a definition for organ donation as most citizens would travel abroad to acquire organs for transplantation. Donating one’s organs or a loved one’s organs upon brain death is a relatively novel concept for the UAE.

Two factors have made it essential for the UAE to develop its own organ transplantation infrastructure. One, travelling abroad for organ transplantation has become increasingly expensive, and two, the recent Istanbul Declaration – an international agreement which aims to combat organ trafficking and transplant tourism – calls for countries to locally implement programmes that will prevent organ failure and completely meet the organ needs of its own citizens.

Formidable challenge

The challenge of starting a transplantation programme from the ground up is a formidable one as the UAE lacks both the technical and the non-technical infrastructure.

Starting a transplantation programme anywhere should be undertaken with a significant degree of forethought. The person ultimately responsible for this endeavour must clearly understand the challenges and risks associated with doing so. Fledgling transplantation programmes can fail anywhere and many have done so, even in the United States. Even in the most favourable circumstances, where societal and legal attitudes are accommodating and available hospital resources are abundant, it takes a long time to start a transplantation programme and take it to completion – much longer than any other medical or surgical programme.

Most of the start-up work is not visible to any but a few people. It is important to clarify to the administration that during the first few years it will seem like nothing is really happening, because indeed there will be very few, if any, transplants done. Most people, physicians and administration alike, associate a surgeon’s success with the number of surgeries done. In fact, in the US remuneration is closely tied to the number and magnitude of surgeries performed. Therefore, it is absolutely crucial to make sure that the sponsoring governmental institution, the hospital administration, and the Department of Surgery realise that there will be a long start-up time and a large consumption of resources upfront.

Realistic expectations

Stakeholders should express realistic expectations depending upon the specific prevailing conditions. This is especially important as the magnitude of non-visible work necessary to successfully launch a multiorgan programme is tremendous. At times, the person undertaking this endeavour will in short order be referred to as “not doing much” around the hospital. It is important that the responsible person possess the ability to weather such criticism with aplomb and not get discouraged. This is part of developing a transplant programme in any hospital and in any country.

The next most important point for a person starting a transplant programme is to determine with a reasonable degree of accuracy whether or not the administration and various departments in the hospital fully support its development. It is well known, once a transplant programme is established, that the timing for any given transplant operation is inherently unpredictable (an organ may appear at any time – and almost without fail it will arrive at 2 am). This is, understandably, never a favourite of many departments in the hospital.

The various departments’ disposition on starting a transplantation programme can be hard to gauge during initial visits to the hospital as everybody is generally on their best behaviour. Thus, what is even more important to measure is whether hospital administration has the ability to make sure that all departments are aligned with the goal. New programmes can certainly be sabotaged and such sabotage comes in two forms – internal and external. Internal usually consists of tying up the fledgling programme in myriad committees, procedures and policies, creating huge issues over minor laboratory variations and incessantly delaying the patients’ transplants, not coming to crucial meetings that would move the patients’ workups forward, discouraging patients from getting transplanted at that institution, and the list goes on. External sabotage usually consists of giving outside referring physicians negative and false information about the new team and programme thus drying up the referral base. The saboteurs will also try to convey the same false information to the sponsoring government institution. Such antics are common in every country.

Lastly, it is also imperative to gauge whether or not the institution has the financial resources to support multiorgan transplantation – it is expensive.

If the above mentioned and myriad other obstacles can be overcome the potential rewards and benefits experienced by the person starting the programme, by the hospital, and especially by the patients, are palpably tremendous.

The UAE example

The UAE did not, as of February 2008, have a transplant programme. Patients, who could afford to, travelled abroad. Others simply stayed on artificial support or died. The Health Authority of Abu Dhabi (HAAD), SEHA (the operational arm of HAAD), and Sheikh Khalifa Medical City-Cleveland Clinic (SKMC) made a very sincere and deep commitment in 2007 to create a comprehensive multi-organ transplant programme. The UAE represented an especially challenging situation as there was no transplant infrastructure, no team personnel, no significant expertise, no legislation to support brain death, no clear legislation allowing organ donation from brain dead donors, no organ procurement infrastructure, and a culture which was not informed or educated regarding organ donation. Thus, this was genuinely a start-from-theground- up procedure. There was clear support from the administration and from HAAD and they certainly had the financial wherewithal to support transplantation. Thus, in this case, both the technical and non-technical aspects had to be developed from the grass roots level.

At present, UAE is performing living related kidney transplants and is working swiftly to get “brain death” legislation passed and move on to liver, pancreas, heart and lung transplantation. Currently, all the Gulf countries have transplantation programmes in various degrees of development and Saudi Arabia has the most developed one. Saudi Arabia and all other Gulf countries also legally accept brain death as one of the two definitions of death.

Technical requirements

The technical requirements for a multi-organ programme (liver, kidney, pancreas, small bowel) are legion. In order for a hospital to perform, for example, a liver transplant successfully and smoothly, essentially every major department in the hospital has to be functioning optimally. There are essentially four broad categories that need to be focused on.

Leadership: Acquiring the right person to lead the programme is the sine qua non of getting the programme off the ground. It must be noted carefully that no matter how many pieces of equipment or fancy buildings a hospital might have, once the first patient enters the operating room this patient must leave the hospital with a perfect outcome. And the second patient! And the third! For achieving this uncompromisingly positive outcome, the maturity and technical expertise of the surgeon is of utmost importance. The hospital and the programme may recover from one bad outcome in the beginning, but recovering from a second or third negative outcome is very difficult.

Personnel: Acquiring or training all other personnel that are responsible for providing crucial support for the transplant patient is essential and this can take a rather long time if there is no infrastructure.

Procurement: Establishing the organ procurement infrastructure is clearly of paramount importance – for as the saying goes “no organs, no transplant.”

Social structures: Creating favourable social, legal, cultural and religious environments, when they do not exist, is also pivotal to the success of a transplantation programme.

An inspirational academic once stated that if you want to start an educational institution, the first thing you do is establish a world class library – if there is money left over then hire some teachers. In any endeavour, it is necessary to clearly identify and distill from the seemingly important, the essential issues necessary to start the journey in the right direction. These core requirements vary depending on the environment. Currently, in the UAE these core requirements involve recruiting an expert surgical/anaesthetic transplantation team and swiftly passing legislation that codifies brain death and organ donation. If these two things can be achieved, the multi-organ transplantation programme can rapidly move towards completely fulfilling the country’s transplantation needs. In the UAE the government is currently focused on legislating brain death as one of the definitions of death and such legislation is expected to be in place by early 2009. Once passed, it is expected there would be no shortage of organs. In fact, there are so many traffic accidents that even if 50% of the potential donors agreed to donate there would most likely be an excess of organs in the UAE (an estimate by the author). At SKMC alone, and that’s only one hospital, there are two to four potential donors per month.

The details

Let’s look at the above four broad categories in some detail. The initial few people, and the leader, who agree to start a transplantation programme from the ground up, in any country, will experience much excitement, exhilaration, exasperation, frustration, absolute dejection and continuous rejection …how appealing!

People are in fact the most valuable asset a hospital has and choosing the right people to initiate the programme is crucial. Why? First, they need to be technical experts in their fields, especially the surgeons. As mentioned above, persistent negative outcomes in a fledgling programme are usually not tolerated. Second, these initial people need to be in possession of a certain character… they need to be very resilient. Any time there is change – and implementation of a multi-organ transplantation programme in a large hospital is a big change – there will be resistance. Resistance comes from many quarters, is prevalent in any large organisation and in any country.

There are two major reasons for it. First, there may be an individual or a department who foresees a major or unfavourable change in their working routine, and second, there may be an individual or a department who sees a large erosion of their influence, power or resources. These two groups will generally try very hard, either openly or surreptitiously, to resist change. This is damaging behaviour – damaging to both the hospital and its patients. It can even completely derail the implementation of a new and valuable programme. However, such derailment does not concern such individuals or departments as they are concerned only with their own needs. It is very difficult to deal with such problems and this is where the newly arrived team may need assistance from colleagues and superiors who support the programme.

Developing or acquiring expertise in other departments within the hospital is the second major task at hand. This requires working with various departments to ascertain whether they have the equipment and personnel needed to take care of, for example, a complicated liver transplant patient. The initial transplant team, or their leader, needs to sit down with all the leaders of these departments and carefully assess their capabilities, identify the deficiencies, and then rectify them. Whereas a complete list would be beyond the scope of this article some of these departments include: Anaesthesia – personnel experienced in liver transplantation anaesthesia

Intensive care – physicians and nurses trained in taking care of transplant patients and familiar with administration of immunosuppressive drugs

Blood banking – extremely important as liver transplants can consume large volumes of blood products

Operating room – needs to have specialised equipment, very expensive, and trained personnel

Nursing personnel – skilled nurses are essential for taking care of these complex patients Human Leukocyte Antigen (HLA) laboratory – cannot do multi-organ transplantation without an HLA laboratory that is intimately familiar with the latest in molecular and cellular immunology, transplant hepatology, transplant nephrology, and immunology and immunosuppression.

As an example of the problems one might face, let’s take the example of the blood banking issue in Abu Dhabi. Adequate blood product supplies are essential for starting liver transplantation, yet Abu Dhabi Blood Bank has only one mobile bus which can reach out to potential blood donors. What’s more, there was a recent ruling in Abu Dhabi that blood donors will no longer be paid for donating. This is anticipated to cause a decline in the amount of blood products available and may very well affect the development of the transplantation programme.

Procurement

Establishing the organ procurement infrastructure is yet another absolute requirement that demands the full attention of the initial team. This assumes that legislation codifying brain death and organ donation either already exists or will soon be enacted.

Establishing a good organ procurement network means establishing an organisation akin to United Network for Organ Sharing (UNOS) in the United States or the Saudi Center for Organ Transplantation (SCOT) in Saudi Arabia. This organisation establishes contact with hospitals for rapid identification of potential donors, helps establish brain death, helps the potential donor’s doctors and nurses create an “approach” team (the people who will approach the family to request donation), manages the medical aspects of the potential donor, matches the organs to recipients on the waiting list, transports the now consented donor to the operating room, assists the surgeon in preparing the patient for organ retrieval, properly manages and packages the organs, and delivers the organs to wherever the designated recipient will receive his transplant.

This is a complex undertaking and it is essential that this process, especially the creation of the approach team, be refined to the extreme to maximise organ donation. As an example, issues that might affect whether a family decides to donate or not include the following: who gives them the bad news of their loved one’s death (does the family trust him/her?), where the news is given (bedside or elsewhere), how much time elapsed between giving them the bad news and requesting donation, who requests donation (ethnic background, position in team taking care of donor, etc), where is the donation request made (by bedside, elsewhere), amount of lighting in the room where the request is made, etc. It becomes readily clear that a large amount of teaching and education in each hospital is necessary to create optimal approach teams.

Organ procurement is pivotal and much attention is being paid to this aspect of developing a transplantation infrastructure in the UAE. SKMC is developing a comprehensive network to efficiently and skillfully handle organ procurement.

Legislation

Legislation codifying brain death and organ donation is the first step in realising a bona fide multi-organ transplantation infrastructure for the country. Once the law is passed there needs to be a comprehensive educational and information campaign for the country. This campaign is very useful for any country at any stage of infrastructural development, as it increases awareness and thus donation rates. However, such a campaign is especially important for a country like the UAE where there is little social awareness of organ donation.

Summary

Starting a multi-organ transplantation programme is a major endeavour and is orders of magnitude more complex than starting other programmes such as cardiac surgery, vascular surgery or any other medical specialty. The reasons are straightforward: it requires a high degree of functionality from many other specialties in the hospital, it entails operating on and putting at risk perfectly healthy people e.g. living organ donors (not done in any other medical specialty), it requires travelling from hospital to hospital looking for people who are brain dead to help your patient (not done in any other specialty), and most confounding, it is intimately dependent upon law, society, religion and culture. It is a major challenge to start such a programme and most importantly, it requires many years and significant resources up front. However, once achieved, there are few endeavours as satisfying and rewarding as setting up an organ transplantation programme.

■ Abrar Khan, MD, MS, MPhil, FACS is Senior Consultant and Director, Transplantation and Hepatobiliary Surgery at Sheikh Khalifa Medical City-Cleveland Clinic Foundation (SKMC), Abu Dhabi. He is a multiorgan Transplant Surgeon and Immunologist and has successfully started, from the ground up, two multi-organ transplantation programmes – one in the United States and one in Abu Dhabi. He is the author of many clinical and basic immunology papers, and has been educated, trained and employed variously at University of California - Berkeley, McGill University, University of California - San Francisco, Harvard Medical School, Yale University - Graduate School of Immunobiology, University of Pittsburgh - Starzl Transplantation Institute, University of Vermont - School of Medicine, and Columbia University (NY). He came from the USA to Abu Dhabi in October 2007 to help start the Transplantation Programme at SKMC.


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ate of upload: 25th January 2009

                                  
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