Version Control Sheet Procedure/ Guideline/Protocol Title Purpose of Procedure/ Guideline/Protocol Version Number Applicable to which Staff Date to be uploaded to Trust Intranet Author of Procedure/Guideline/ Protocol Consultation Periods Authorised Date Authorising Authority Authorisation Information Next Review Date (3 year default) Keywords Links From Other Sections Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory Guideline for Staff Reference Version 1.0 Midwifery & Obstetric Staff within Integrated Maternity & Women’s Health Division ???? Integrated Maternity & Women’s Health Division Guideline Committee 26/08/10 – 16/09/10 ???? Integrated Maternity & Women’s Health Division Guideline Committee Amendments Required Approved Not Approved Deferred 2013 SHSCT Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory (27 September 2010) Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory 1. Introduction 1.1 When a patient experiences a pregnancy loss at any gestation they have a right to know that their baby will be treated by everyone in a respectful manner. Staff should be aware of and sensitive to the feelings of the patient or couple and provide information and support in a format and language which is appropriate and will be helpful to their particular circumstances and consistent with their needs, abilities and preferences. Staff will remember that the availability of written and other information does not negate their personal support role. 1.2 Staff must take account of the patient’s wishes with regard to explaining any examination of the pregnancy tissue and the options available for disposal. 1.3 This protocol applies to the handling and transfer to laboratory services of early miscarriage tissue/products of conception i.e. Tissue from a pregnancy that ended in the first trimester and/or where the fetus, if present, is <6cms crown-rump measurement Tissue from a pregnancy that ended before 20 weeks gestation and/or where the fetus, if present, is >6cms crown-rump measurement 2. Handling and Transfer Protocol 2.1 All miscarriage tissue/products of conception, including ectopic pregnancies, should be sent for histopathological examination to the laboratory, to confirm pregnancy and examine for molar disease etc. (see laboratory services handbook on intranet) having first obtained the patient’s consent. 2.2 Tissue from an early pregnancy loss that has been passed in the ward/theatre where there is a no visible fetus or where any fetus present is less than 6cms, should be SHSCT Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory (27 September 2010) transferred to the laboratory fixed in Formalin in an opaque container labelled with the patients details. 2.3. If more than one sample of tissue is passed when a patient has miscarried e.g. some tissue passed in ward before going to theatre where more will be retrieved, this tissue may be transferred discretely with the patient to theatre so that all the tissue can be sent to the laboratory together. 2.4 Where a foetus is greater that 6cm size it would be suitable for a full post mortem investigation. Where consent for this examination has been given it will take place at the Paediatric Pathology Service in Belfast who advise the following; The fetus should be sent fresh to the laboratory in Daisy Hill or Craigavon as quickly as possible in an opaque white box labelled with the patient’s details from where it will be transferred to Belfast. In order to maintain the integrity of the fetal tissue there should be as little handling of the fetus as possible. To keep the tissue moist the fetus may be placed in a clear plastic bag before placing it in the white box. To prevent movement in transit some non absorbent padding may be required in the base of the white box. Formalin is not required for this transfer. Any placental tissue should be put in a plastic bag and placed separately in a white plastic bucket without formalin and sent with the fetus in its box to the Laboratory. 2.5 Individual samples must be labelled as well as the transport container. 2.6 A “Consent Form for Histopathological Examination and Disposal of Early Miscarriages” should be completed by a member of the medical/nursing team who has received training on the principles of consent and bereavement care in these circumstances. This form is for tissue from a pregnancy that ended before 12 weeks gestation where any foetus visible is less that 6cms. This examination usually takes place in the Trust’s histopathology laboratory. 2.7 A “Consent Form for a Hospital Post Mortem Examination of a Baby” should be completed for a pregnancy that ended before 20 weeks gestation and where the fetus is greater than 6cms. This examination takes place at the Regional Paediatric Pathology Service, Royal Victoria Hospital, Belfast. The laboratory/Mortuary service will arrange this transfer. 2.8 The Regional Paediatric Pathology Service requests that the doctor seeking consent for this examination informs them that a baby post mortem is required (see attached protocol for arranging a post mortem). The Regional Paediatric Pathology Service can be contacted by calling (028) 90632625 or (028) 90633274 or during Out of Hours/Weekends call 07714345277 and leave a message. Information the Paediatric Pathology Service require include the Mother’s name and address, ward and hospital, gestational age and expected time of arrival if possible. SHSCT Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory (27 September 2010) 2.9 The consent forms are in triplicate; the white copy of the consent form should be sent with the sample to the laboratory, a copy should be given to the patient and a copy retained in the medical record. Consent forms must travel with the sample. NB it is the mother’s details that are required on the form i.e. Baby of …etc. 2.10 If consent for an Evacuation of Retained Products of Conception (ERPC) procedure is being sought, it would be appropriate to seek consent for examination and disposal of tissue at the same time and send the consent form to theatre with the patient. When it has not been possible to discuss or complete the appropriate consent for examination form before going to theatre e.g. in an emergency, this should be completed as soon as possible after surgery and sent to the laboratory. 2.11 The consent process also requires that the patient should be made aware of the disposal options available once the pregnancy tissue has been examined and that their wishes are recorded on the consent form. 2.12 For first trimester miscarriages and/or where any fetus is less than 6 cms size, a ‘Histopathology/Cytopathology Request Form’ must also be completed and accompany the specimen to the laboratory. 2.13 For foetuses greater than 6 cms size, if a post mortem is required, a member of the medical staff must complete a clinical summary on the ‘Request Form for PM Examination of a Baby’ as required by the Regional Paediatric Pathology Service and forward to the laboratory with the foetus. 2.14 All specimens must either accompany the patient to theatre or be placed in the ward collection box. 3. Out of hours/ weekends arrangements. 3.1 If a fetus requires a post mortem, staff must be aware that the tissue will be placed in the laboratory fridge and therefore must ensure that the on call laboratory services are contacted and informed of the imminent transfer of fetal tissue. DHH – inform the Biomedical Scientist on-call CAH – inform the Haematology Biomedical Scientist on-call Both of these numbers are available via the switchboard 4. Arrangement for Transfer to Laboratory 4.1 All fetuses/products of conception specimens from pregnancies that ended less than 20 weeks gestation are to go to the laboratory on the respective hospital sites along with the appropriate examination request and consent forms. 4.2 Nursing/Midwifery staff should contact the onsite Laboratory to inform them of the transfer. SHSCT Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory (27 September 2010) 4.3 For fetuses greater than 6 cms a Body Transfer Form should be completed and attached to the fetal container to accompany it to the Laboratory. 5. Disposal of Tissue Following examination, disposal of tissue should be as directed by the patient on the consent form Options: If hospital disposal is selected, the tissue will be cremated at Roselawn. As indicated on the consent form ashes cannot be returned as so little ash is produced. If the patient wishes to take the remains home for burial the tissue will be sent to the hospital mortuary where the mortuary technician will contact the family to arrange for them to collect the tissue. SHSCT Procedure for the Handling of Early Miscarriage Tissue/Products of Conception up to 20 weeks gestation in the Ward/Theatre and Transfer to Laboratory (27 September 2010) 1. Protocol for Arranging Pathology Examination of Miscarriage Tissue of Less Than 20 Weeks Gestation Consideration should be given to the pathological examination of the Products of Conception (POC) for all women who miscarry. In “Early miscarriage”, where there is no visible fetus or any fetus is less than 6cms size, limited pathological examination of the tissue can be carried out in the local Histopathology Laboratory. For miscarriages, where the fetus is greater than 6cms size, a full post-mortem examination may be possible. The size of any fetus determines the degree of examination, where the examination takes place, how the products of conception (POC) are transferred to the Pathology Services and the types of Consent Form and Pathological Examination Request Form used. Staff involved with seeking and obtaining consent and supporting relatives must have a knowledge of the post mortem process and procedures and have attended relevant training No Fetus or Fetus Less Than 6 cms Fetus Greater than 6 cms (up to 20 weeks) Consent Form Required – “Consent Form for Histopathological Examination and Disposal of Early Miscarriages” Consent Form Required - “Consent for Post Mortem Examination of a Baby” Discuss examination with Mother (and Partner) – Information Booklet available Discuss examination with Mother (and Partner) Record if Consent for Examination is given or withheld. Complete section that records patient’s wishes regarding disposal of remains Correct Completion/Filing of Consent Form: Use ink- not address label 1. White Copy with POC to Laboratory 2. Yellow Copy to Mother 3. Pink Copy placed in Mother’s Medical Record Record if Consent for Post Mortem is given or withheld. Complete section that records patient’s wishes regarding disposal of remains Correct Completion/filing of Consent Form: Use ink – not address label 1. White Copy with fetus and placenta to Laboratory 2. Yellow Copy to Mother 3. Pink Copy placed in Mother’s Medical Record Complete appropriate Pathology Examination Request Form Regional Paediatric Pathology Post Mortem Request Form Complete appropriate Pathology Examination Request Form. ie Histopathology/Cytopathology Request Form Mode of Transfer: Doctor should telephone Regional Paediatric Pathology Service: 028 90632625 or 028 90633274 to “book” Post Mortem and discuss case. Out of Hours/Weekends call 07714345277 and leave a message Opaque White Bucket Formalin Transfer to Onsite Laboratory: Nursing/Midwifery staff should contact the onsite Laboratory informing them of the transfer Send to Local Laboratory with all required forms Mode of Transfer: Suitable sized white box for fetus, no formalin. All other tissue including placenta in separate white bucket No formalin. Transfer to Onsite Laboratory: Nursing/Midwifery staff should contact the onsite Laboratory informing them of the transfer and complete Tissue/Body Transfer Form Send to Laboratory with all required forms. Laboratory will arrange onward transfer to Regional Paediatric Pathology. SHSCT Protocol for arranging pathology examination of miscarriage tissue less than 20 weeks Gestation (G. McCusker / A. Coyle 27 September 2010)