Model Protocol

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

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

Normative chapters

This Model Protocol complies with the requirements that the law sets 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.

Authorities

This Model Protocol does not always indicate which officials are authorized to perform a specific task. The hospital must determine this itself. This may vary per hospital.

See also fillable form in which the authorized officials can be indicated.

Facilitating tissue donation should be the starting point for healthcare institutions, but they are not obliged to make donation possible. A physician does not have to consult the Donor Register if this procedure is not possible within the healthcare institution. If this is the case, the healthcare institution must have a donation protocol. If there are no contraindications for tissue donation, the attending physician determines from 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 containing the latest insights and standards for organ donation and transplantation, based on recent scientific research.
• Publisher: EDQM, Council of Europe – 9th edition (2025).

Download the guideline

For readability, the male pronoun is used in this protocol. Naturally, she/her and they/them can also be read here.

Patient

A person admitted to the hospital, whose death is expected soon or who has passed away, and who may potentially be a donor.

Next of kin

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

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

Read who exactly falls under the next of kin (4.7)

Loved ones

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

NB: In the Wod, a clear distinction is made between 'loved ones' and 'next of kin'. When it comes to informing about the registration and subsequent steps, the official may address all loved ones. However, as soon as consent for donation is required, only the next of kin have decision-making authority. Furthermore, only the next of kin may object to the nature of the registration or to the donation. A loved one who is not next of kin may not do this.

Donation conversation

The entirety of conversations with loved ones in the context of a potential donation. The donation conversation takes place prior to any tissue and/or organ removal and after the 'bad news conversation' has been conducted.
The donation conversation consists of 2 parts:

• Initial part: conversation in which the official discusses the registration in the Donor Register with the loved ones. In this conversation, the official also provides information about donation and – if applicable – asks the next of kin up to the 2nd degree or a specific person for consent for donation.
• Specific part: conversation in which the official provides more information about which specific organs, tissues, and harvested required body material are medically suitable for donation. For this, they ask the loved ones for information about the patient's social and medical history. The official also discusses the planning of the procedure in this conversation.

NB: The above division into the 'initial part' and the 'specific part' of the donation conversation was made to provide more structure and clarity. However, in practice, such a separation cannot be made so strictly, as the same items may occur in both parts. In that case, the initial part and the specific part are merged into a single conversation. This also depends on the specific information needs of the loved ones.

Official

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

Incompetent

This concerns incapacity regarding organ and tissue donation. An incompetent person is someone who is 'unable to reasonably assess the interests involved' and who cannot 'weigh the significance of the facts in light of their own priorities'.

In the case of donation, a person lacks capacity if they are unable to understand what donation entails and/or to foresee the consequences of donation. As a result, this person lacks the basis upon which capable persons base their choice. People with an intellectual disability are not necessarily incapable when it comes to donation. Whether someone lacks capacity is a medical assessment, not a legal one.

See 3.4.1. for children under 12 years of age

Duty of due care

The duty of due care pertains to the patient's decision-making capacity. The new Organ Donation Act explicitly establishes this duty of due care. The relevant article contains the conditions that must be met before the procedure for organ/tissue removal begins. One of those conditions is that the designated official must ascertain the patient's capacity at the time of registration.

Make plausible

In the event of a 'yes' or 'no objection' registration, surviving relatives can make it plausible (4.10) that the registration does not correspond to the patient's wishes.

Are the surviving relatives convinced that the 'yes' or 'no objection' registration is incorrect? Then they must make this known and explain it to the official. How they do this is informal. The law speaks of 'making plausible', without this being further defined. It is not about 'proving', but about 'setting out' and 'explaining'. The official asks the surviving relatives to explain why they believe the registration does not correspond to the patient's wishes.

If they can explain this sufficiently convincingly, the registration may become invalid and the information from the surviving relatives applies. It is up to the professional judgment of the official to decide whether they can trust that the registration corresponds to the patient's wishes.

Resident

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

Donation Quality Standard

Quality standard drawn up in the context of the 2020 amendment to the Organ Donation Act. This quality standard focuses on consulting the Donor Register and the subsequent conversation with relatives and surviving relatives. The standard records existing donation practices and translates the new elements of the Organ Donation Act into practice. The quality standard is 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 2010/45/EU (pdf, 810 kb)
• EU Directive 2004/23/EC (pdf, 246 kb)
• Organ Donation Act
• Body Material Safety and Quality Act
• Body Material Safety and Quality Decree
• Body Material Safety and Quality Regulation

• Appendix 1: Contact details of donation professionals and authorities of officials. This is a blank version. Each hospital completes its own overview.
• Appendix 2: Brain death determination form
• Appendix 3: National umbrella 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.
• Postbus 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.

This publication was produced in cooperation with: the Ministry of Health, Welfare and Sport, (various working groups within) the Dutch Transplant Society and the Dutch Society for Intensive Care.

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