Model Protocol

Overview of all changes in the Model Protocol for post-mortem organ and tissue donation.

This Model Protocol is an example protocol for hospitals. Hospitals can use it to review their own hospital protocol and adjust it as necessary.

Normative chaptersThis Model Protocol complies with the legal requirements for a hospital protocol. The chapters in the protocol have varying legal statuses. If a chapter has a normative basis – and therefore may not be deviated from – this is explicitly stated.

Powers

This Model Protocol does not always specify which personnel are authorized to perform a particular task. The hospital must determine this for itself. This can differ from hospital to hospital.

See alsoformin which the competent officials can be displayed.

Facilitating tissue donation should be a guiding principle for healthcare institutions, but they are not obliged to enable donation. A physician is not required to consult the Donor Register if this procedure cannot be performed at the healthcare institution. If this is the case, then the healthcare institution must have a donation protocol in place. If there are no contraindications for tissue donation, the attending physician determines, based on their own professional responsibility, whether the Donor Register is consulted. This also applies to the general practitioner if the patient dies at home.

• The ‘Guide to the Quality and Safety of Organs for Transplantation’ is a comprehensive European guideline featuring the latest insights and standards for organ donation and transplantation, based on recent scientific research.
• Edition: EDQM, Council of Europe – 9th edition (2025).

Download the guideline

For readability, the masculine form 'he' is used in this protocol. It should, of course, be understood that 'she/her' and 'they/them' are also implied.

Patient

A person admitted to the hospital, whose death is imminent or who has died, and who may be a donor.

Next of kin

Next of kin may, under the Organ Donation Act (ODA), have decision-making authority in certain cases. Next of kin have the option to object to the nature of the registration or to the donation. This primarily concerns the partner. In their absence or unavailability: blood relatives (1st and 2nd degree). And in their absence or unavailability: relatives by marriage (1st and 2nd degree). No distinction is made between the 1st and 2nd degree.

N.B.: In the Wod, the term 'next of kin' is also used for situations where the patient has not yet died. This also applies to this protocol.

Read who exactly is considered next of kin (4.7)

Loved ones

People who played a (significant) role in the patient's life, such as a neighbor or a good friend, including (but not limited to) next of kin up to the 2nd degree.

NB: In the Wod, a clear distinction is made between next of kin and bereaved family members. When it comes to informing about the registration and the subsequent steps, the official can address all next of kin. However, as soon as consent for donation is required, only the bereaved family members are authorized to make decisions. Furthermore, only the bereaved family members may object to the nature of the registration or the donation. A next of kin who is not a bereaved family member may not do so.

Donation conversation

The entirety of conversations with the next of kin in the context of a possible donation. The donation conversation takes place prior to any potential tissue and/or organ retrieval and after the 'bad news conversation' has been held.
The donation conversation comprises 2 components:

• Initial phase: a conversation in which the official discusses the registration in the Donor Register with the next of kin. In this conversation, the official also provides information about donation and, if applicable, requests consent for donation from the next of kin up to the second degree or from a specific person.
• Specific part: a conversation in which the official provides more information about which specific organs, tissues, and collected necessary bodily material are medically suitable for donation. For this, he asks the next of kin for information about the patient's social and medical history. The official also discusses the planning of the procedure in this conversation.

Note: The above division into the 'initial part' and the 'specific part' of the donation conversation has been made to provide more structure and clarity. However, such a separation cannot be made so strictly in practice, as the same topics may arise in both parts. In that case, the initial part and the specific part are combined into a single conversation. This also depends on the specific information needs of the next of kin.

Official

Person who conducts the initial part of the donation conversation. The professional can be a doctor or another medical professional.

Incapable

This concerns incapacity to make decisions regarding organ and tissue donation. An incapacitated person is someone who ‘is unable to reasonably appreciate the interests involved’ and who cannot ‘weigh the significance of the facts in light of their own priorities’.

In the case of donation, someone is deemed to lack capacity if they are unable to understand what donation entails and/or to comprehend the consequences of donation. Consequently, this person lacks the basis upon which individuals with capacity make their choices. People with an intellectual disability are not necessarily deemed to lack capacity when it comes to donation. Whether someone lacks capacity is a medical assessment, not a legal one.

See 3.4.1. for children younger than 12 years old

Duty to ascertain

The duty of verification pertains to the patient's capacity to make decisions. In the new organ donation act, it has been decided to explicitly lay down this duty of verification. The relevant article contains the conditions that must be met before the procedure for removing organs/tissues begins. One of those conditions is that the designated professional must ascertain the patient's capacity to make decisions at the time of registration.

To make plausible

In the case of a 'yes' or 'no objection' registration, next of kin can make a case for (4.10) that the registration does not correspond to the patient's wish.

Are the next of kin convinced that the 'yes' or 'no objection' registration is incorrect? Then they must communicate this and explain it to the official. No specific form is required for how they do this. The law refers to 'making plausible,' without further definition. It is not about 'proving,' but about 'setting out' and 'explaining.' The official asks the next of kin to explain why they believe the registration does not correspond with the patient's wish.

If they can explain this convincingly enough, then the registration can be invalidated, and the information from the next of kin will apply. It is up to the professional judgment of the official to decide whether he can trust that the registration matches the patient's wishes.

Resident

A natural person who is registered in the Personal Records Database. In practice, this means that this person has their actual place of residence in the Netherlands.

Quality Standard Donation

Quality standard developed as part of the 2020 amendment to the Organ Donation Act. This quality standard focuses on consulting the Donor Register and the subsequent conversation with next of kin and bereaved relatives. The standard records existing donation practices and translates the new components of the Wod into practice. The quality standard has been integrated into chapters 3 and 4 of this model protocol.

To the Quality Standard

These abbreviations appear in the Model Protocol.

The most important laws and guidelines for donation in the Netherlands are:

• EU Directive 2010/53/EU
• EU Directive 2004/23/EC
• Organ Donation Act
• Human Bodily Material Safety and Quality Act
• Decree on Requirements for Human Bodily Material 2006

• Appendix 1:Contact details of donation professionals and authorities of officials. This is a blank version. Each hospital fills in its own overview.
• Appendix 2:Brain Death Determination Form
• Appendix 3:National overarching hepatitis B protocol (2.7)

The Model Protocol for Post-mortem Organ and Tissue Donation is a publication of the Dutch Transplant Foundation (NTS).

• Haagse Schouwweg 6 - 2332 KG - Leiden.
• PO Box 2304 - 2301 CH - Leiden.
• info@transplantatiestichting.nl

All rights reserved. No part of this publication may be reproduced, in any form or by any means, without prior permission from the Dutch Transplant Foundation.

The publication was released in collaboration with: the Ministry of Health, Welfare and Sport, (various working groups within) the Dutch Transplantation Society, and the Dutch Society for Intensive Care.

This publication was made possible in part thanks to financial support from the Ministry of Health, Welfare and Sport.