Model protocol for tissue donation
The model protocol for post-mortem organ and tissue donation describes the course of the donation procedure step by step.
1. The tissue donation process
This protocol describes the procedure for post-mortem tissue donation. The procedure consists of 8 steps, some of which run in parallel. These steps are described chapter by chapter.
The diagram shows which steps are involved and in which chapters they are addressed.
The tissue donation process starts with the identification of potential donors. Next, the process for obtaining consent for the donation begins. Naturally, information is provided to the family about what tissue donation entails. Once consent or agreement has been obtained, the donor is registered with the Organ Center and tissue retrieval is initiated.
2. Donor identification
A tissue donor can be identified and registered anywhere in the hospital. This chapter describes:
- Which patients are eligible for tissue donation?
- What are the most common contraindications for tissue donation?
2.1. Conditions for tissue donation
Any deceased person who meets the conditions below can become a tissue donor:
- The date and time of death are known.
- None of the three general contraindications apply.
In all other cases, consult the Organ Center via 071 579 57 95 regarding the possibility of tissue donation.
2.2. General contraindications
Table 4 lists the most common general contraindications for tissue donation. Do any of the mentioned diseases or disorders apply to the past? If so, tissue donation is not possible. Only in that case is it not necessary to consult the Donor Register.
If no general contraindication according to Table 4 applies, contact the Organ Center to discuss or register a tissue donor. The Organ Center has the latest information regarding tissue-specific contraindications for tissue donation.
Table 4: General contraindications for tissue donation
| Contraindication | Examples and explanation |
|---|---|
| BMI > 40 | |
| Hematological malignant and premalignant conditions at the time of death or in the past. | Leukemia, non-Hodgkin lymphoma, multiple myeloma, polycythemia vera, and myelodysplastic syndrome. |
| Degenerative diseases of the central nervous system of unknown origin or with a prion-like pathogenesis. | Parkinson's, ALS, MS, and all forms of dementia. |
2.3. Donation not possible, what now?
Is there a contraindication as described in table 4? Then tissue donation is not possible. In that case, do complete the donation form and indicate: 'No donation'. Fill in the contraindication(s) as well.
3. Consult the Donor Register and determine subsequent steps
For tissue donation, consulting the Donor Register and determining the subsequent steps is the same as for organ donation.
See: Model protocol for organ donation: Consulting the Donor Register. You will find here:
- How, by whom, and when should the Donor Register be consulted?
- What do the various registrations mean, and what is expected of the official per type of registration?
A distinction is made between competent patients and incompetent patients. For incompetent patients, the procedure for tissue donation differs slightly from that for organ donation (see 3.3 organ donation)
Organ Donation Act (Wod)
All paragraphs in chapter 3 are a practical elaboration of the Organ Donation Act (Wod). Therefore, no deviation from these is permitted. Figure 11 shows where these steps are located in the tissue donation process.
4. The donation conversation
Following the consultation of the Donor Register, a conversation with the patient's next of kin regarding their registration in the Donor Register always takes place. We refer to this conversation as the initial part of the donation conversation.
The guidelines for this conversation are the same for tissue donation as for organ donation. Therefore, we refer you to the Model Protocol for Organ Donation Donation Conversation (chapter 4).
That chapter describes:
- What are the starting points for the conversation and interaction with the next of kin?
- Who conducts this conversation?
- With which next of kin and surviving relatives does the conversation take place?
- How can the official handle any objections to the registration or the donation?
Chapter 4 is a practical elaboration of the Organ Donation Act (Wod). Therefore, no deviation from this is permitted.
5. Provision of information to family
Throughout the entire procedure, it is important to properly inform the family of the (potential) donor about the donation process. This is the responsibility of the physician. This chapter provides the physician with tools for this purpose.
Various topics may be discussed during the conversation with the family about tissue donation.
- General information.
- Donation of specific tissues.
- Discussing the registration in the Donor Register and – if necessary – asking for consent for donation is covered in chapter 4.
Throughout the process, it is important to respond to the family's need for information. This is up to your professional judgment as a physician.
5.1. General topics
In the conversation with the family about tissue donation, it is advisable to discuss at least the following:
- Tell the family which tissues the deceased can donate based on the contraindications and what these tissues can be used for after donation. Indicate that it will only become clear after retrieval and medical screening whether, and which tissues, can actually be transplanted. Hand over the brochure: 'Tissue donation: information for relatives'. Order form can be found at: information material
- Indicate that the donor will be treated with respect throughout the entire procedure.
- Is there a case of unnatural death? If so, state that permission from the public prosecutor is required for the release of the body. Tissues can only be retrieved after the public prosecutor has released the body.
- State that the deceased can be laid out in the usual manner and be buried or cremated. Laying out at home is also possible.
- Indicate that the deceased may have to stay in the hospital for a few hours longer due to the retrieval procedure. This can be 8 to 30 hours longer. Mention that the funeral director must contact the mortuary as soon as possible regarding when the deceased can be picked up after donation. This must happen within 3 hours after the end of the donation.
- After retrieval of the tissues, further research is necessary to rule out any risks and to check whether the quality of the tissues is sufficient. The research is conducted by the staff physician of the NTS and the tissue bank. Tell them that it can happen that donated tissue turns out not to be suitable for transplantation.
- Ask if the relatives wish to be kept informed of the donation by means of a letter.
- If tissue turns out not to be suitable for transplantation, it can be used for transplantation-related research. No transplantation-related research is conducted if the donor or their family has objected to this.
Share the online information or give the family the brochure 'Tissue Donation - Information for surviving relatives' (order it here). This allows them to read through the information at their own pace.
5.2. Information about specific tissues
This section describes for each tissue what it is used for, how the donation and retrieval procedure works, and what points of attention there are when laying out the donor. Which topics are discussed depends on the information needs of the family.
5.2.1. Eye tissue
Transplantations of donated eye tissue aim to greatly improve the recipient's vision and reduce pain. Eye tissue transplantation can take place in people with perforations, keratoconus, congenital abnormalities, infections, a tumor, or trauma.
Donation procedure
During eye tissue donation, the retrieval team removes the entire eye. They place prostheses back. The eyelids are closed, after which nothing more of the retrieval can be seen. After eye tissue donation, a bluish discoloration around the eyes can sometimes be seen. The funeral director or retrieval team will cosmetically restore this.
5.2.2. Skin tissue
Donated skin tissue can be used in various ways. First, it is used as a temporary biological dressing in the treatment of burns. This reduces pain, increases the chance of survival, and reduces scarring. Once the burn has healed, the donor skin eventually falls off by itself. Therefore, donor skin usually does not grow onto the body as the person's own skin. Second, skin tissue is used as an implant for abdominal wall defects. This involves 'full-thickness' skin. This does grow onto the body as the person's own skin.
Donation procedure
The retrieval team takes skin from the back, flank, legs, and buttocks of the deceased. These are usually thin layers of skin. Sometimes a thicker layer is also taken from the back. After the procedure, the deceased is dressed in a suit that covers the body. This may be slightly visible at the neck and arms, but it is usually easy to conceal under the clothing of the deceased. The suit is necessary because the body may lose fluids after the procedure. The funeral director can no longer wash the body of the deceased after skin donation.
5.2.3. Heart valves
Donated heart valves are used for reconstructive surgery of congenital abnormalities and after certain bacterial infections. These involve patients whose heart is no longer able to properly pump blood through the body, resulting in the body receiving too little oxygen. This leads to severe fatigue and shortness of breath. A transplanted heart valve can help patients lead a normal life again.
Donation procedure
The heart valves are retrieved via a sternotomy, using a Y-incision. For a heart valve donation, the entire heart is removed. At the heart valve bank, the valves are dissected and inspected. If permission has been granted for this, a limited pathological-anatomical examination can be performed on the remains of the heart.
The incision wound is closed after donation, sutured, and covered with a plaster. If clothing covers it (for the viewing/laying out), nothing of it can be seen. However, it is advised not to dress the donor in low-cut clothing, as the plaster may then be visible.
5.2.4. Bone, cartilage, and tendon tissue
Donated bone, cartilage, and tendons are mainly used in orthopedic surgery. Donor bone can replace affected bone after, for example, cancer or surgery. In this way, donor bone can prevent the need for limb amputations. Cartilage is primarily used for the reconstruction of the nose. Tendon tissue is used to repair damaged joints. For rheumatism patients, transplanted tendon tissue can be a solution.
Donation procedure
Bone, cartilage, and tendon tissue must be retrieved in an operating room because this must be done sterilely. Operating room staff do not need to be present. The retrieval team brings all necessary materials themselves. The retrieval procedure takes approximately 6 hours, including preparation and completion.
Bone is removed from the legs, upper arms, pelvis, and sometimes the ribs. Occasionally, a piece of bone from an elbow or a shoulder blade is retrieved. The latter only happens if a patient is on the waiting list for it. Various tendons are removed from the legs, such as the Achilles and toe flexor tendons.
Rib cartilage can be retrieved from donors who donate bone and tendon tissue as well as heart valves. Retrieval of the rib cartilage takes place after the heart has been removed and before the thorax is closed. The rib cartilage is attached to the sternum at the front of the chest. The rib cartilage is retrieved starting from halfway down the sternum, alternating downwards. In this way, the shape of the chest cavity is preserved as well as possible after retrieval. On the outside, it looks the same as after the donation of heart valves.
The retrieved bone tissue is replaced by naturally degradable prostheses. The incision wounds are sutured and covered with plasters. If clothing is worn over this, nothing can be seen. However, it is advised not to dress the donor in shorts, a short skirt, or short-sleeved clothing, as the plasters might then be visible. Should the surviving relatives have indicated that they do want this, the retrieval team will take this into account. Surviving relatives can no longer wash the deceased themselves after a bone donation. There are no connections between the prostheses, which means the body is less stable during dressing and will feel different.
6. Registering a donor
This chapter describes how the physician registers a tissue donor with the Organ Centre, and what conditions apply to this. This chapter also discusses the intake interview and the questions asked during it. Finally, this chapter outlines the procedures that apply to the acceptance or rejection of a registered donor.
6.1 Registering a donor
A tissue donor is registered with the Organ Centre via 071 579 57 95. An intake interview takes place with an employee of the Organ Centre. Depending on the complexity of the donor and the number of suitable tissues, the intake interview takes an average of about 20 minutes.
6.2 When must a donor be registered?
In the event of any death in the hospital, it is mandatory to investigate whether donation is possible. A donor can be registered for tissue donation if the 3 criteria below are met:
- At the time of registration, no general contraindications are known.
- The Donor Register has been consulted.
- The donor or surviving relatives have given permission or consent for tissue donation. In the case of an unnatural death, permission from the public prosecutor for the release of the body is also required for tissue donation prior to retrieval. The public prosecutor's permission can also be obtained after registration.
6.3 Who can register a donor?
Which officials within your hospital are allowed to register a donor is described in Appendix 1. The person registering the donor is registered in the BIG register or does so under the responsibility of an official registered in the BIG register. It is important that the person registering the donor possesses sufficient medical knowledge and knows the deceased's file. The person registering the donor must be certain:
- that there is consent for tissue donation from the donor or their surviving relatives. And:
- that the family is sufficiently informed about the tissue donation process.
6.4 What does the intake interview involve?
When registering a donor, an intake interview takes place with an employee of the Organ Centre. This interview discusses whether the potential donor is suitable for tissue donation.
The Organ Centre employee asks questions about the medical and social situation of the donor. Based on this information, they assess whether the patient is medically suitable for tissue donation.
6.5 What questions can you expect in the intake interview?
During the intake interview, the Organ Centre employee asks questions. It is wise to be prepared for this by looking up the requested information in advance and discussing it with the surviving relatives where necessary. The tissue questionnaire contains:
- Questions about the medical file
- Questions for the surviving relatives
- Tissue-specific questions
- Practical questions
6.6 Following the registration of the donor
After you have registered the donor, the deceased can be transferred to the mortuary. In some cases, this has already happened. The transfer takes place according to the hospital's usual procedure. Send a fully completed and signed donation form along to the mortuary. Tell the mortuary employee that a donation will still take place. Raise the head slightly so that it is higher than the chest (for example, with a pillow).
If it appears that the deceased is suitable to donate tissues, the deceased must be cooled in the mortuary within 6 hours of circulatory arrest.
Look in chapter 7 for more information on the preparation for tissue retrieval.
What if the Organ Centre needs more information?
Following the registration interview, the Organ Centre evaluates the donor. The Organ Centre may need more information in order to accept the donor.
To this end, the Organ Centre may contact the general practitioner, or in specific cases, an attending specialist in another hospital. Whether this is necessary depends on the tissues in question and the amount of information you, as the registering physician, were able to provide.
6.7 What is the procedure upon acceptance of the donor?
The Organ Centre informs the registering physician by telephone regarding the acceptance of the donor. The physician will then also be informed as to which tissues the acceptance applies to.
Subsequently, it is the physician's duty to inform the donor's surviving relatives about the acceptance. Once the donor has been accepted by the Organ Centre, the retrieval team is called up. This team is responsible for the retrieval of the tissues.
6.8 What is the procedure upon rejection of the donor?
If a tissue donor has been registered and the Organ Centre has determined that the deceased cannot donate, the Organ Centre will notify the registering physician of this by telephone.
The Organ Centre will also call the mortuary to communicate that no tissue will be retrieved. Subsequently, it is the physician's duty to inform the donor's surviving relatives about the rejection.
6.9 What rules apply to the sharing of medical data?
The Organ Centre requires relevant medical information about the donor in order to assess whether the tissues are suitable for donation. The central objective is to keep the risks for the recipient(s) of the tissue(s) as low as possible. Therefore, it is important to map out these risks as completely as possible.
For that reason, the Organ Centre has the authority to request all data from healthcare institutions that are important for the medical screening of tissue donors. This is laid down in the Wod (Tissue-based Materials Act). If an institution fails to share this data with the Organ Centre, the tissue donation cannot proceed. The Organ Centre ensures that the data is adequately protected.
7. Preparation for tissue retrieval
This chapter provides (practical) information on the steps preceding tissue retrieval. This chapter also describes the priorities set when multiple tissues are available for donation. Finally, the chapter addresses the situation in which an autopsy on the body must take place in addition to the tissue donation.
7.1 Cooling the donor and elevating the head
The first step in the tissue donation procedure is cooling the donor. This must be done in a cold room. Cooling with a cooling plate alone is insufficient. The following guidelines apply for this:
- Preferably place the donor in the cold room within 6 hours of death.
Is the donor also donating eye tissue?
- Position the donor's head higher, so that it is higher than the chest.
- Close the eyelids.
- Do not place eye caps.
Was the donor not cooled within 6 hours of death? Then we refer to this as an uncooled donor. In that case, it is not always possible anymore to retrieve (all) tissues. Would you like to know what the possibilities are with an uncooled donor? Then contact the Organ Centre via 071 579 57 95.
7.2 Tissue retrieval: where, when and how long?
Tissues are retrieved by a specially trained tissue retrieval team. Tissues can be retrieved in a mortuary, autopsy room or funeral home. Only in the case of bone, cartilage and tendon tissue donation must the retrieval take place in an operating theatre.
In Table 7 you can see per type of tissue:
- At which location can the tissues be retrieved?
- How long does the procedure take?
- How soon must the retrieval begin after death?
Table 7: Practical information on tissue retrieval
| Type of tissue | Location of retrieval | Duration of retrieval procedure | Start of retrieval procedure for a donor cooled within 6 hours | Start retrieval procedure for uncooled donor |
|---|---|---|---|---|
| Eye tissue | Mortuary | ± 1 hour | Within 24 hours | Within 12 hours |
| Skin | Mortuary | ± 1.5 hours | Within 24 hours | Within 12 hours |
| Heart valves | Mortuary | ± 2 hours | Within 24 hours | Not possible |
| Bone and tendon tissue | Operating room | ± 6 hours | Within 24 hours | Within 12 hours |
Please note:
- A dissection table with water drainage is required for skin retrieval.
7.3 Collecting post-mortem blood
Before tissues are retrieved, the tissue retrieval team collects post-mortem blood from the donor. Serology tests are performed on this blood. This checks whether the donor had any diseases that could pose a hazard to the recipient.
Is it not possible to collect blood from the donor? Or is this blood unsuitable for performing the serology tests? Then the Organ Centre will check whether blood from the donor is available in the hospital that was collected earlier and is suitable for these tests. If this blood is available, it will be used for the serology tests. The tissues can then still be donated.
Is there no suitable blood available? Then the tissue donation cannot proceed. The Organ Centre will inform the notifying physician about this.
7.4 Autopsy and tissue retrieval: sequence and conditions
Will an autopsy be performed on the donor's body? If so, the following conditions apply to the sequence of tissue retrieval and the autopsy:
- Ocular tissue and skin can be retrieved both before and after the autopsy.
- Heart valves can only be retrieved before the autopsy.
- Bone, cartilage, and tendon tissue are preferably retrieved before the autopsy, but this can also be done afterwards if necessary.
- A combination of autopsy and skin, bone, and tendon tissue donation is not possible. In that case, the skin donation will not proceed.
If tissue retrieval takes place after the autopsy, blood from the donor must be secured before the autopsy begins. This blood is required for serological testing. The Organ Centre, together with the retrieval teams, ensures that this is done.
In the case of heart valve donation, the registering physician and the Organ Centre will discuss during the intake interview whether the heart must remain available for autopsy or whether it can be donated.
Following donation, a limited pathological-anatomical examination of the remaining parts of the heart can be performed upon request. The Organ Centre can provide more information on which conditions and abnormalities can still be identified from the pathological-anatomical examination after donation. The results of this examination are communicated to the registering physician or pathologist.
7.5 Other procedures in combination with tissue donation
7.5.1 Thanatopraxy (temporary embalming)
Thanatopraxy is generally possible in combination with the donation of ocular tissue and heart valves. Due to vascular damage, the combination of thanatopraxy with skin donation and with bone and tendon tissue donation is not possible.
There is sometimes a lack of clarity among surviving relatives or physicians regarding the possibilities for thanatopraxy after donation. Thanatopraxy is now offered and performed by a large number of funeral directors. In practice, the experience and expertise of thanatopractors vary, as does the information provided by the funeral director/thanatopractor to the surviving relatives. Some thanatopractors inform the relatives that the combination with donation is not possible because they cannot perform the procedure after donation. As a result, surviving relatives are sometimes forced to make a choice. Unfortunately, the NTS has limited influence on this.
7.5.2 Ritual washing
Washing rituals, which occur in various religions, involve the use of water to purify the body and mind. After the ritual washing, the body is wrapped in a white cloth and may no longer be touched. Therefore, tissue donation must take place before the ritual washing. Skin donation is not possible in the event of a ritual washing, but donation of other tissues is. Discuss the combination of donation and ritual washing with the Organ Centre.
7.5.3 Combination of organ and tissue donation and body donation to science
It can happen that a deceased person has registered with an anatomical institute and consent for donation has also been given. The NTS cannot check whether a deceased person has registered with an anatomical institute. The NTS only discovers this if the physician reports it during consultation or registration. In most cases, the physician is aware of this because the surviving relatives have indicated it to the physician.
Some universities (anatomical institutes) can still accept a body for science following organ and tissue donation, but not all of them. Furthermore, it is not always possible to donate all tissues in combination with body donation to science. This depends, among other things, on the method of preservation and therefore varies per anatomical institute. The Organ Centre knows per anatomical institute whether the combination of organ or tissue donation and body donation to science is possible.
If someone has given consent for organ and tissue donation and has also registered with an anatomical institute, donation generally takes precedence. The Organ Centre employee advises the physician to inform the surviving relatives about this. If the combination of donation and body donation to science is not possible, the surviving relatives must make a choice.
8. Aftercare for surviving relatives in a tissue donation procedure
This chapter describes how the NTS informs the donor's surviving relatives about the results of the tissue donation. This only happens if the relatives wish this themselves. The chapter also describes where relatives can go with questions and how thank-you letters from recipients are handled. Diagram 16 indicates that this step takes place after the tissue donation procedure.
8.1 Checking the need for aftercare information with the surviving relatives
When a tissue donor is registered with the Organ Center, the Organ Center employee asks whether the surviving relatives need information about the donation. This concerns information about which tissues have been recovered.
Explicitly ask the surviving relatives whether or not they wish to receive this information. This prevents them from receiving information they do not appreciate. If they do wish to receive the information, ask the surviving relatives for the correct correspondence address and the recipient's last name and initials. This ensures that this information reaches the right person.
8.2 How and about what are the surviving relatives informed?
If the donor's surviving relatives have indicated that they wish to receive information about the donation, they will receive a letter from the NTS within a few days to a week. In this letter, the NTS lets them know which tissues were recovered from the donor. The donation coordinator handles the provision of information to the registering physician in the hospital.
This letter to the surviving relatives is also accompanied by the brochure 'After tissue donation, information for loved ones'. This brochure contains general information about tissue donation.
Do the surviving relatives have specific questions about the tissue donation? Then they can contact the NTS, mentioning the reference number from the recovery letter, via:nabestaanden@transplantatiestichting.nl.
8.3 Thank-you letters from recipients of donated tissues
It occurs with some regularity that a recipient of tissues wants to thank the donor's surviving relatives. The NTS or a donation coordinator from the hospital in question then acts as an intermediary and forwards the thank-you letter anonymously, in consultation with the surviving relatives.
8.4 How is the family informed if the donor donates both organs and tissues?
Has a donor donated both organs and tissues? Then the involved organ donation coordinator ensures that the family is adequately informed about this.