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 per chapter.
The diagram shows which steps are involved and in which chapters they are covered.
The tissue donation process starts with the identification of potential donors. After that, the process for obtaining consent for the donation begins. This naturally involves providing information 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 begins.
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.
- There are none of the three general contraindications.
In all other cases, consult the Organ Center at 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. Is there a history of any of the mentioned diseases or conditions? If so, tissue donation is not possible. In that case, it is not necessary to consult the Donor Register.
If there is no general contraindication according to Table 4, contact the Organ Center for consultation or to 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 (Kahler's disease), 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? If so, tissue donation is not possible. In that case, please fill out the donation form and indicate: 'No donation'. Include the contraindication(s).
3. Consult the Donor Register and determine follow-up steps
For tissue donation, the same rules apply as for organ donation regarding consulting the Donor Register and determining follow-up steps.
See: Model protocol for organ donation: Consulting the Donor Register. You will find here:
- How, by whom, and when must the Donor Register be consulted?
- What do the different 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 is slightly different than 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). Deviations from this are therefore not permitted. Figure 11 shows where these steps are located in the tissue donation process.
4. The donation conversation
After consulting the Donor Register, a conversation always takes place with the patient's next of kin regarding the registration in the Donor Register. We call this conversation 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 to the Model Protocol Organ Donation Donation Conversation (chapter 4).
That chapter describes:
- What are the principles 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). Deviations from this are therefore not permitted.
5. Providing information to family
Throughout the entire procedure, it is important to keep the family of the (potential) donor well-informed 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 addressed 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 – requesting consent for donation is covered in chapter 4.
Throughout the entire process, it is important to respond to the family's need for information. This is left 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 contraindications and what these tissues can be used for after donation. Indicate that it will only be clear after the retrieval and medical screening whether, and which, tissues can actually be transplanted. Hand over the brochure: Tissue Donation
- Indicate that the donor is treated with respect throughout the entire procedure.
- Is it a case of non-natural death? If so, explain that the public prosecutor's permission is required for the release of the body. Tissues can only be retrieved after the public prosecutor has released the body.
- Explain that the deceased can be laid out and buried or cremated in the usual manner. Laying out at home is also possible.
- Indicate that the deceased may need to remain 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 collected after donation. This must happen within 3 hours after the completion of the donation.
- After the retrieval of the tissues, further examination is necessary to rule out any risks and to check whether the quality of the tissues is sufficient. The examination is performed by the NTS staff physician and the tissue bank. Explain that it may happen that donated tissue turns out to be unsuitable for transplantation.
- Ask if the next of kin wish to be kept informed about the donation by means of a letter.
- If tissue turns out to be unsuitable for transplantation, it can be used for transplantation-oriented research. No transplantation-oriented research is conducted if the donor or their family has objected to this.
Share the online information or give the family the leaflet 'Tissue Donation - Information for surviving relatives' (order it here). This allows them to read through the information again at their leisure.
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
Transplants of donated eye tissue aim to significantly 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
When donating eye tissue, the retrieval team removes the entire eye. They place prostheses back. The eyelids are closed, after which nothing of the removal can be seen. After eye tissue donation, some discoloration around the eyes may sometimes be visible. The funeral director or the retrieval team will restore this cosmetically.
5.2.2. Skin tissue
Donated skin tissue can be used in various ways. Firstly, 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. Donor skin therefore usually does not grow on as one's own skin. Secondly, skin tissue is used as an implant for abdominal wall defects. This involves 'full-thickness' skin. This does grow on as one's own skin.
Donation procedure
The retrieval team takes skin from the back, the side, the legs, and the buttocks of the deceased. These are usually thin layers of skin. A thicker layer is sometimes also taken from the back. After the operation, 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 hide under the deceased's clothing. The suit is necessary because the body may lose fluid after the operation. 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 some bacterial infections. This concerns patients whose heart is no longer able to pump blood through the body properly, causing the body to receive 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, by means of a Y-incision. For a heart valve donation, the entire heart is removed. The valves are dissected out at the heart valve bank. If permission is granted for this, a limited pathological-anatomical examination can be performed on the remains of the heart.
The incision wound is closed, sutured, and covered with a plaster after donation. If clothing is worn over it (for the laying out), nothing can be seen. It is, however, advised not to dress the donor in low-cut clothing, as the plaster may then be visible.
5.2.4. Blood vessels
In the case of infected prostheses, it may be decided to transplant blood vessels. The patient's own blood vessels are then too damaged.
5.2.5. Bone, cartilage, and tendon tissue
Donated bone, cartilage, and tendons are primarily used in orthopedic surgery. Donor bone can replace damaged bone after, for example, cancer or surgery. In this way, donor bone can prevent the need for limb amputation. Cartilage is mainly used for nasal reconstruction. 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 removed in an operating room because this must be done under sterile conditions. No OR staff 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 shoulder blade is removed. The latter only happens if there is a patient 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 removed from donors who donate bone and tendon tissue as well as heart valves. Removal 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 removed alternately downwards starting from halfway down the sternum. In this way, the shape of the chest is preserved as well as possible after the removal. On the outside, it looks the same as after the donation of heart valves.
The removed 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 may then be visible. If the next of kin have indicated that they do wish to do this, the retrieval team will take this into account. Next of kin cannot wash the deceased themselves after a bone donation. There are no connections between the prostheses, which means the body is less stable and will feel different during dressing.
6. Registering a donor
This chapter describes how the physician registers a tissue donor with the Organ Center and the conditions that apply to this. This chapter also covers the intake interview and the questions asked during it. Finally, this chapter states 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 Center via 071 579 57 95. An intake interview takes place with an employee of the Organ Center. Depending on the complexity of the donor and the number of suitable tissues, the intake interview takes approximately 20 minutes on average.
6.2 When must a donor be registered?
For every 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 the next of kin have given permission or consent for tissue donation. In the case of an unnatural death, permission from the public prosecutor is also required for the release of the body for tissue donation prior to removal. Permission from the public prosecutor can also be obtained after registration.
6.3 Who may 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 who is registered in the BIG register. It is important that the person registering the donor possesses sufficient medical knowledge and is familiar with the file of the deceased. The person registering the donor must be certain of:
- that there is consent for tissue donation from the donor or their next of kin. And:
- that the family is sufficiently informed about the tissue donation process.
6.4 What does the intake interview entail?
When registering a donor, an intake interview takes place with an employee of the Organ Center. In this interview, it is discussed whether the potential donor is suitable for tissue donation.
The Organ Center employee asks questions about the donor's medical and social situation. 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 Center employee asks questions. It is wise to be prepared for this by looking up the requested information in advance and discussing it with the next of kin where necessary. The tissue questionnaire contains:
- Questions about the medical record
- Questions for the next of kin
- Tissue-specific questions
- Practical questions
6.6 After donor registration
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 to the mortuary. Tell the mortuary staff that a donation is still going to take place. Position the head slightly higher so that it is higher than the chest (for example, with a pillow).
If it appears that the deceased is suitable for donating tissues, the deceased must be cooled within 6 hours after circulatory arrest.
Seechapter 7 for more information about preparing for tissue retrieval.
What if the Organ Center needs more information?
After the registration call, the Organ Center assesses the donor. It may be that the Organ Center needs more information to be able to accept the donor.
For this purpose, the Organ Center may contact the general practitioner, or in specific cases, a treating specialist at another hospital. Whether this is necessary depends on the tissues in question and the amount of information you, as the registering physician, have been able to provide.
6.7 What is the procedure upon acceptance of the donor?
The Organ Center informs the registering physician by telephone about the acceptance of the donor. The physician is then also informed for which tissues the acceptance applies.
Subsequently, it is the physician's task to inform the donor's next of kin about the acceptance. After the donor has been accepted by the Organ Center, the retrieval team is called in. 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 Center has determined that the deceased cannot donate, the Organ Center will inform the registering physician by telephone.
The Organ Center also calls the mortuary to inform them that no tissue will be retrieved. Subsequently, it is the physician's task to inform the donor's next of kin about the rejection.
6.9 What rules apply to the sharing of medical data?
The Organ Center requires relevant medical information about the donor to assess whether the tissues are suitable for donation. The central focus is to ensure that the risks to the recipient of the tissue(s) are as small as possible. Therefore, it is important to map these risks as completely as possible.
For this reason, the Organ Center 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 (Wet op de orgaandonatie - Organ Donation Act). If an institution does not share this data with the Organ Center, the tissue donation cannot proceed. The Organ Center ensures that the data is adequately protected.
7. Preparation for tissue retrieval
This chapter provides (practical) information about the steps that precede tissue retrieval. This chapter also describes the priorities that are set if multiple tissues are available for donation. Finally, the chapter addresses the situation in which an autopsy must be performed on the body 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 storage room. Cooling with only a cooling plate is insufficient. The following guidelines apply to this:
- Preferably place the donor in the cold storage unit within 6 hours after death.
Is the donor also donating eye tissue?
- Place the donor's head slightly higher, so that it is higher than the chest.
- Close the eyelids.
- Do not place eye caps.
Has the donor not been cooled within 6 hours after death? Then we refer to this as an uncooled donor. In that case, it is not always possible to retrieve (all) tissues. Would you like to know what the possibilities are for an uncooled donor? Please contact the Organ Center at 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 room.
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 quickly must the retrieval begin after death?
Table 7: Practical information regarding tissue retrieval
| Type of tissue | Location of retrieval | Duration of retrieval procedure | Start of retrieval procedure for a donor cooled within 6 hours | Start of retrieval procedure for an 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 |
Note:
- For skin retrieval, a dissection table with a water drain is required.
7.3 Post-mortem blood collection
Before tissues are retrieved, the tissue retrieval team collects post-mortem blood from the donor. Serology tests are performed on this blood. This is to check whether the donor had any diseases that could pose a risk to the recipient.
Is it not possible to collect blood from the donor? Or is this blood unsuitable for performing the serology tests? In that case, the Organ Center 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 Center will inform the notifying physician about this.
7.4 Autopsy and tissue retrieval: sequence and conditions
Is an autopsy being performed on the donor's body? If so, the following conditions apply to the sequence of tissue retrieval and the autopsy:
- Eye tissue and skin can be retrieved 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 Center, together with the retrieval teams, ensures that this is done.
In the case of heart valve donation, the notifying physician and the Organ Center will discuss during the intake interview whether the heart must remain available for autopsy or if it can be donated.
After donation, a limited pathological-anatomical examination can be performed on the remains of the heart if desired. The Organ Center 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 passed on to the notifying physician or pathologist.
7.5 Other procedures in combination with tissue donation
7.5.1 Thanatopraxy (light embalming)
Thanatopraxy is generally possible in combination with the donation of eye tissue and heart valves. Due to damage to blood vessels, the combination of thanatopraxy with skin donation and with bone and tendon tissue donation is not possible.
There is sometimes confusion 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. The experience and expertise of thanatopractors vary in practice, as does the information provided by the funeral director/thanatopractor to the surviving relatives. Some thanatopractors inform relatives that the combination with donation is not possible because they cannot perform the procedure after donation. As a result, relatives are sometimes forced to make a choice. The NTS unfortunately 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 must no longer be touched. Therefore, tissue donation must take place before the ritual washing. Skin donation is not possible with a ritual washing, but donation of other tissues is. Discuss the combination of donation with the ritual washing with the Organ Center.
7.5.3 Combination of organ and tissue donation and body donation to science
It may occur that a deceased person has registered with an anatomical institute and there is also consent for donation. The NTS cannot see whether a deceased person has registered with an anatomical institute. The NTS only finds out if the physician reports this during consultation or notification. In most cases, the physician is aware of this because the surviving relatives have indicated it to the physician.
Some universities (anatomical institutes) can accept a body for science even after organ and tissue donation, but not all. Furthermore, not all tissues can always be donated in combination with body donation to science. This depends, among other things, on the method of preservation and therefore differs per anatomical institute. The Organ Center knows for each anatomical institute whether the combination of organ or tissue donation and body donation is possible.
If someone has given consent for organ and tissue donation and has also registered with an anatomical institute, donation generally takes priority. The Organ Center staff member advises the physician to inform the surviving relatives about this. When the combination of donation and body donation 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 next of kin about the results of the tissue donation. This only happens if the next of kin wish for this themselves. The chapter also describes where the next of kin can go with questions and how thank-you letters from recipients are handled. Figure 16 indicates that this step takes place after the tissue donation procedure.
8.1 Checking the need for aftercare information with the next of kin
If a tissue donor has been registered with the Organ Center, the Organ Center employee asks whether the next of kin would like information about the donation. This concerns information about which tissues have been retrieved.
Explicitly ask the next of kin whether or not they wish to receive this information. This prevents them from receiving information they do not want. If they do wish to receive the information, ask the next of kin for the correct correspondence address and the recipient's surname and initials. This ensures that this information reaches the right person.
8.2 How and about what are the next of kin informed?
If the donor's next of kin have indicated that they wish to receive information about the donation, they will receive a letter from the NTS within a few days. In this letter, the NTS states which tissues were retrieved from the donor. The donation coordinator provides the information to the registering physician at the hospital.
The 'After tissue donation' brochure is also enclosed with this letter to the next of kin. This brochure contains general information about tissue donation.
Do the next of kin have specific questions about the tissue donation? They can then contact the NTS by email, stating the reference number from the retrieval letter:nabestaanden@transplantatiestichting.nl.
8.3 Thank-you letters from recipients of donated tissues
It happens regularly that a recipient of tissues wants to thank the donor's next of kin. The NTS or a donation coordinator from the relevant hospital then acts as an intermediary and, in consultation with the next of kin, forwards the thank-you letter anonymously.
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.