DIRECTORATE OF PATHOLOGY Standard Operating Procedure PROCEDURE FOR THE SENSITIVE DISPOSAL OF THE NON VIABLE FETUS (i.e. up to 23 weeks and 6 days gestation) Recommending Committee: Approving Signature: Designation: Pathology Management Dr Sheila Kelly Consultant Histopathologist Date: April 2010 Version Number: 5 Date: April 2010 Review Date: March 2012 Responsible Officer: Karen Unsworth Equality Impact Assessment Outcome Level (high, medium, low) LOW Review date March 2012
Appendix 1 Minimum Data Set For Approval Process Title Procedure for the sensitive disposal of the Non Viable Fetus Author/s Departmental Service Manager Cellular Pathology/Mortuary Services Responsible officer Departmental Service Manager Cellular Pathology/Mortuary Services Purpose To ensure correct pathway is followed for sensitive disposal of the Non Viable Fetus Reference Page 10 of document Approval date April 2010 Implementation date April 2010 Amendment date April 2010 Version number 5 Review date April 2012 Consultation/recommending Obstetrics, Gynaecology and groups Midwifery Services Bereavement Office Pathology Department Clinical Risk Management Department Spiritual Care Department Cremation Authorities Royal Liverpool Children s Hospital- Alder Hey (RLCH) Histology Department Approved by Consultant Histopathologist Target population/distribution Clinical Staff For information to Laboratory and Mortuary staff Training needs Ward based training Financial consequences N/A Superseded document Procedure for the sensitive disposal of the Non Viable Fetus Version 4 Equality impact assessment April 2010 Page 2 of 10
Contents Clinical (Ward Based) Procedure o Non-Viable Fetuses Up To 15 Weeks And 6 Days Gestation/Products Of Conception. o Non- Viable Fetuses From 16 Weeks To 23 Weeks And 6 Days Gestation. Laboratory Procedure Implemenation And Audit N.B. The procedures for stillbirths are covered in the document: 'Procedure for the Sensitive Disposal of Stillborn infants' The procedure for live births at any gestational age are covered in the document Procedure for the Sensitive Disposal of Live births All enquiries relating to individual cases should initially be made to the Bereavement Office (Extension 1336), who will co-ordinate the Trust response. Further copies are available on the Intranet Page 3 of 10
CLINICAL (WARD BASED) PROCEDURE The procedures for dealing with products of conception and /or recognisable fetal remain up to 23 weeks and 6 days gestation are the same for all clinical staff. (See appendix 1 and appendix 2 Midwives documentation) The specimen should be fixed in formalin ONLY after appropriate ward based investigations are complete e.g. cytogenetics (COSHH 3, sensitiser). SPECIMENS WHICH ARE RECEIVED WITHOUT A COMPLETED CONSENT FORM AND/OR THE MINIMUM DATA SET FOR IDENTIFICATION AND/ OR APPROPRIATE CLINICAL DETAILS WILL BE RETURNED - THUS DELAYING THE REPORT Non-viable fetuses up to 15 weeks and 6 days gestation/products of conception. 1) Non- viable fetuses up to 15 weeks and 6 days gestation and products of conception undergo histological examination at Whiston. 2) These specimens MUST be placed in an appropriately sized opaque specimen container and covered with formalin. (COSHH 3, sensitiser) 3) The mother MUST complete Consent form 10. NOTE: Where communication is necessary with the patient/carer/next of kin Alternative formats of communication will be available on request (e.g. translation services, sign language services) 4) Clinical staff MUST: Complete Healthcare Professionals section of Consent Form 10. The white copy is to be sent to the Histology Department with the specimen and completed histology request form. The yellow copy is to be given to the mother. The blue copy is sent to the Bereavement Office. The pink copy is filed in the mother's medical records. 5) The specimen container MUST be labelled with the following information: mother's name a minimum of two from- Maternal date of birth, unit number, address date of miscarriage hazard status (as necessary) location (ward / department) Page 4 of 10
6) The specimen container MUST be accompanied by a signed completed histology request form giving the following information mother's name a minimum of two from - Maternal date of birth, unit number, address date of miscarriage hazard status (as necessary) location (ward / department) Consultant clinical information 7) If the mother does not wish for histopathological examination to be performed: Consent form 10 MUST be completed The fetus or products of conception must be placed in appropriately sized opaque specimen container and covered with formalin (COSHH 3, sensitiser) The white copy of Consent form 10 and a completed Histology request form are sent with the specimen to the Histology department for sensitive disposal. Non- viable fetuses from 16 weeks to 23 weeks and 6 days gestation. Fetus and Placenta to go to RLCH (Alder Hey) for post-mortem examination. 1) If the parents wish to have a post-mortem examination of a fetus from 16 weeks to 23 weeks and 6 days gestation this is carried out at RLCH (Alder Hey). 2) The Royal Liverpool Children s Hospital (Alder Hey) consent booklet and a Consent form 10 MUST be completed by the mother. 3) Clinical staff MUST: Complete Healthcare Professionals section of Consent Form 10. The white copy is to be sent to the Mortuary with the specimen. The yellow copy is to be given to the mother. The blue copy is sent to the Bereavement Office. The pink copy is filed in the mother's medical records. 4) The fetus and placenta should be placed in an appropriately sized opaque specimen container. 5) The specimen container MUST be labelled with the following information: mother's name a minimum of two from- Maternal date of birth, unit number, address date of miscarriage hazard status (as necessary) location (ward / department) Page 5 of 10
6) Clinical staff MUST complete a Royal Liverpool Children s Hospital - Alder Hey Request for fetal, perinatal or infant post mortem examination form. Mothers GP details MUST be completed. The fetus and placenta are sent to Whiston Mortuary together with the following: Document Required Request for fetal, perinatal or infant post mortem examination form. Photocopy of Mother s relevant case sheets Completed copy of Consent form 10 Blue copy of page 11 RLCH Blue copy of page 12 RLCH Blue copy of page 13 RLCH Blue copy of page 14 RLCH Blue copy of page 15 RLCH Blue copy of page 17 RLCH Blue copy of page 18 RLCH Blue copy of page 19 RLCH Notes This must be fully completed and signed. These must be sent This must be completed This must be completed This must be completed and one of the boxes ticked Child s name & unit number must be completed and one of A, B or C ticked Child s name & unit number must be completed and one of the boxes ticked Child s name & unit number must be completed and one of the boxes ticked This must be completed This must be completed Only if an interpreter has been used. UNLESS ALL THESE COMPLETED DOCUMENTS ARE RECEIVED, THE FETUS WILL NOT BE ACCEPTED IN THE WHISTON MORTUARY. RLCH WILL NOT CARRY OUT A POST-MORTEM EXAMINATION WITHOUT THE CORRECTLY COMPLETED PAPERWORK. 7) The fetus and placenta are transferred to RLCH (Alder Hey) by the Trust contracted Funeral director. Page 6 of 10
Non- viable fetuses from 16 weeks to 23 weeks and 6 days gestation cont d. Fetus not for examination Even if the mother does not wish for histopathological examination of the fetus Consent form 10 MUST be completed. The fetus must be placed in appropriately sized opaque specimen container and sent to Whiston Mortuary with the white copy of Consent form 10. Placenta only to go to RLCH (Alder Hey) for examination 1) If only the placenta is being sent to RLCH for examination the placenta must be placed in an appropriately sized opaque specimen container and covered with formalin (COSHH 3, sensitiser). 2) Complete the form Royal Liverpool Children s Hospital Alder Hey Request for examination of the placenta and a Histology request form. 3) Send the placenta and both completed request forms to Histology department at Whiston. 4) The placenta will be transferred to RLCH (Alder Hey) via Trust transport. Page 7 of 10
LABORATORY PROCEDURE St Helens and Knowsley Teaching Hospitals NHS Trust 1) Only specimens with an accompanying completed Consent Form 10 and a Histology Request Form will be given an accession number. Any specimens sent without either of the forms or an incomplete Consent form 10 MUST be returned to original sender/location. (See Histology SOPs 1.0, 1.3). 2) The completed consent form must accompany the request form through the laboratory and the reporting process and be filed with the request form. 3) The lid of the specimen container is labelled with a red spot. If the mother indicates on Consent form 10 that they wish any taken tissue to be reunited with the products of conception/fetus then the lid of the specimen container is also labelled with a green spot.(see Histology SOP 7.7). 4) The specimen should be examined by a pathologist and if following this it is determined that the specimen consists only of maternally derived tissues i.e. placenta/ decidua, the specimen can be disposed as per Trust policy (See Histology SOP 7.3) 5) If the examining pathologist identifies fetal tissues a Fetal tissue retention document and a Cremation Document (respecting individual religious, cultural and other wishes where cremation may not be appropriate) are to be completed by a Consultant Pathologist. These forms will be stored in the Fetal Retention Document file within the Histology department. 6) The pathological examination of such specimens will be tailored to take account of completed consent form: - if no consent has been obtained for the examination of fetal parts, placental tissue only will be sampled for microscopic examination, and examination of fetal tissues will be limited to external description and measurement. 7) When pathological investigations are complete the specimen must be sealed in a Bitran bag and placed in a casket labelled with the minimum data set for identification and the laboratory accession number. Specimens will be submitted for sensitive disposal unless the completed Consent form 10 indicates other arrangements are required (see point 9)). 8) Specimens are stored in the laboratory for 6 week, after which they are transferred to the Mortuary accompanied by the Fetal tissue retention document, cremation documents and photocopy of Consent form 10. (See Histology SOP 7.4). A record of all specimens sent for sensitive disposal is kept in the Histology department. Page 8 of 10
9) Specimens are stored in the Mortuary for 1 week, after which the specimens are collected by the Trust contracted funeral director for sensitive disposal. The Fetal tissue retention document must be completed by the Mortuary staff and the Funeral director. Four copies are made, one sent to the Histology Department, one to the Bereavement Office, one to be kept in file in the mortuary and one given to the funeral director. The Funeral director also takes the Cremation documents and the photocopy of Consent form10. The original completed document to be sent to the Medical Records Department to be filed in the mother's medical record. 10) If the family wish to be involved with the sensitive disposal of the specimen, the Bereavement Office should contact the Histology laboratory (ext. 1828) who will prepare the specimen for collection by the Funeral director. On the day of collection the relevant parts of 'Fetal tissue retention document' are completed by the member of Histology staff handing over the specimen and the Funeral director. Three copies are made, one given to the Funeral director, one sent to the Bereavement Office and one to be kept in file in the Histology department. The original completed document to be sent to the Medical Records Department to be filed in the mother's medical record. NOTES: All specimens can be tracked through the Histology department by use of the Telepath computer system or the filed paper records which are kept for 30 years. If anyone wishes to have a copy of the Histology SOPs listed please contact the department on ext 1828. COSHH hazards are numbered: 1 = Toxic 5 = Irritant 2 = Corrosive 6 = Explosive 3 = Harmful 7 = Oxidising 4 = Highly Flammable 8 = Toxic Fumes under Fire Conditions More detailed information in the form of Data Sheets is available in the Histology COSHH Handbook. Staff should familiarise themselves with COSHH data prior to performing a procedure. Page 9 of 10
Implementation and Audit St Helens and Knowsley Teaching Hospitals NHS Trust Implementation This policy will be available on the Trust intranet and will be a controlled document via the Pathology Quality Management System. Full adherence to the policy will be implemented one calendar month after authorisation. Audit Audit of compliance will be undertaken as part of the annual internal audit of the Pathology Quality Management System. References Human Tissue Authority Code of Practice 5 Disposal of Human Tissue September 2009 The Cremation (England and Wales) Regulations 2008 (effective January 2009) Page 10 of 10