Introduction of the updated DHSSPS consent forms, information booklets

and regional consent policy - early miscarriage and baby

Dr Grainne McCusker, Clinical Director Pathology and Laboratory Services

Anne Coyle , Bereavement CoordinatorJanuary 2012

Hospital Post Mortem Examination

Background to review of forms

Revision was necessary following a Human Tissue Authority (HTA) inspection of pathology services in the Belfast and Western Trusts in 2009/10

A small number of amendments were needed for the form to comply with the current requirements of the Human Tissue Act (2004) e.g. retention of tissue for scheduled purposes

The HSC Pathology and Bereavement Networks were tasked with revising the existing forms and booklets

 

Purpose of forms To record the consent decisions made by an

individual in a ‘qualifying relationship’ or with ‘parental responsibility’ to the deceased about the undertaking of a post mortem examination and the storage, further use and disposal of the tissue and organs examined

There are now 3 PM consent forms

1) Adult/Child (forms merged)2) Baby (up to 28 days old)3) Early Miscarriage Forms colour coded with

accompanying information booklet

Order of form changed e.g. confirmation of consent is now last section

Checklist aid on the back

Plans for Introduction to clinical areas and training New training programme that includes an e-learning

module is in development and should be available from April 2013

In the meantime - holding updates to prepare clinicians who may seek consent for PM

Initial focus on the areas where a consented PM is requested most - Obstetric, Gynaecology and Neonatology

NB Evidence that the clinician who has taken consent for PM has attended training is now audited by HTA

Specific responsibilities for staff working in obstetric and gynaecology practice1. Explaining the examination that is possible to

help patients understand its purpose and make decisions

2. Recording consent decisions for the histopathological examination of early miscarriages

3. Recording consent decisions for hospital PM examination of a baby

NB these forms also record the wishes of the parents in relation to what happens to the tissue/fetus after examination

PM consent in context… Consent is a process, not an

event, whereby individuals freely agree to specified procedures, fully informed of the purpose, advantages, disadvantages and alternatives. 

The process may involve several conversations, questions and explanations in preparation for the formal consent being recorded

Preparing to discuss post mortem with the family You will be seeking

consent at a time when relatives are distressed and vulnerable

Breaking bad news guidance and communication strategies can be helpful

The process is a team effort

The discussion should include… Honest, clear, objective information The opportunity to ask questions Reasonable time to reach decisions Privacy for discussion with other family members Emotional/psychological support An opportunity to change their minds within an

agreed time limit A realistic timeframe for results and the way in

which these will be communicated

Documenting Consent… Use the correct consent

form The forms are in triplicate -

please ensure copies reach their destination;

NB: if PM is offered and consent declined, a consent form must always be completed to record that decision, then a copy given to the person from whom consent was sought and the remaining copies filed in the patient’s notes

Histopatholological Examination and Disposal of Early Miscarriages This form is to be used when

there is no fetus or any foetus present is less than 6cm Crown Rump size, usually a first trimester loss

Consent is required for the examination of the fetus or fetal parts

5 sections

Advice for completing this form Part 1 – Patient details Part 2 – Information for patient about tissue

examination – this section explains that the miscarried tissue, usually placental and decidua only, is routinely examined but the mothers consent is specifically needed for the examination of any embryo, fetus or fetal parts that may be found in in the tissue sample in the laboratory

Part 3 - Examination of Fetal remains - records the patient’s consent decision for this examination in the relevant tick box

Advice for completing this form

Part 4 – Disposal of Tissue from miscarriage – this section explains that the hospital cremates any unprocessed tissue after examination. The tick boxes only need to be completed if the woman indicates that she wants the tissue returned after examination to dispose of personally*

Part 5 – Confirmation of Consent Decision – follow instructions to record both the patients and consent takers signatures

Consent for Hospital Post Mortem Examination of a Baby This consent form must

be used for all babies > 6cms crown rump size and up to 28 days of age.

NB It might be necessary for you to view the fetus to decide on the correct examination to request and correct form to use

Advice for completing this form Part 1 – Baby’s and Mother’s details: DO NOT USE

ADDRESSOGRAPH LABELS as information needs to go through all copies

Part 2 – Extent of PM examination – this section explains that the PM may be full, limited to a particular part of the body or an external examination only. The tick boxes record the mother’s/parent’s decision for the extent of the examination

Part 3 – Tissue Samples: storage and further use- this section records the mother’s/parent’s decisions for the storage and further use of tissue samples taken as part of the PM examination

Advice for completing this form Part 4 – Retention of organs for further examination-

explains that sometimes an organ(s) may need to be retained for a few weeks before it can be examined. It also records consent for disposal of these organ(s)

Part 5 – Choice regarding burial or cremation of baby- records the mother’s/parent’s decision in relation to return of their baby’s body. They can indicate if they want the baby returned to them for a family burial/cremation or choose the hospital to arrange disposal. In the Southern Trust hospital disposal is by cremation 

Part 6 – Confirmation of Consent Decision – follow instructions to record both the mother’s/parent’s and the consent taker’s signatures

Checklist – arranging the PM

The Checklist on the back of the form guides its completion and triggers the arrangements required to organise the PM.Please lean lightly on the checklist to minimise marks transferring onto the consent form – having the form fully open helps

Protocol for arranging examination < 20 weeks gestation: Placenta/POC/Fetus is sent to the

laboratory (CAH or DHH) and onward to Belfast if a PM is required

> 20 weeks gestation: fetus/baby sent to Mortuary who arrange for transfer to Belfast if PM requested

Key points

liaise with nursing/midwifery staff to contact the Laboratory or Mortuary to let them know to expect a fetus and start arrangements for transfer

it is important that the doctor taking consent contacts the Regional Paediatric Pathology Service to arrange/book the PM

Regional Policy for Consent for Hospital PM Examination

Guides practice regarding consent for hospital PM examination across all HSC Trusts.

Outlines the procedure and process summary for obtaining valid consent in compliance with the Human Tissue Act.

Useful contacts

Dr Grainne McCusker (CAH) Consultant Pathologist Ext 2685 or

Grainne.McCusker@southerntrust.hscni.net

Anne Coyle, Trust Bereavement Coordinator (CAH)

Ext 3861 or Anne.Coyle@southerntrust.hscni.net