This document describes the HTA’s policy on the management and traceability of tissue samples retained by independent pathologists when undertaking post mortem examinations (PME) at HTA-licensed premises where they are not employed.
The aims of this policy are:
- to set out the HTA’s expectations with regards to the management and traceability of tissue samples retained by independent pathologists, and the responsibilities of the Designated Individual (DI) at the premises on which the PME takes place;
- to document the HTA’s position on licensing requirements in relation to PM tissue stored by independent pathologists whilst awaiting instruction from coroners and police, and
- to mitigate the risks of non-compliance with HTA standards and regulatory requirements.
Through enquiries and inspections, the HTA has become aware of the need for clarification about the practices of independent pathologists. There are several situations where independent pathologists visit HTA-licensed establishments to carry out post mortem examinations:
- Where there are no staff pathologists, for example at public mortuaries
- Where there are vacancies which require external pathologists to be used on a temporary basis
- Where there are no forensic pathologists on staff
- Where staff pathologists carry out surgical histopathology only (some NHS Trusts have adopted this approach in response to the rarity of consented/hospital post mortems).
It is routine practice for independent pathologists to take or send PM tissue away from the originating establishment for laboratory processing and/or analyses. This may be because these services are not available at the establishment where the post mortem took place, or because the pathologist has preferred laboratory services based where their offices are located or with another provider.
When the laboratory analyses are complete, independent pathologists may store PM tissue on their own premises whilst they await the receipt of disposal instructions from the coroner or police.
It is the HTA’s position that premises on which independent pathologists store relevant material whilst they are awaiting disposal instructions from coroners or the police do not require an HTA licence.
In agreeing this policy, the HTA has taken into account two key factors: (i) the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 allow a licensing exemption where relevant material is sent from a licensed establishment to unlicensed premises for analyses, as long as it is returned to the licensed establishment on completion of the analysis* ; (ii) the storage of relevant material while awaiting instructions from a coroner or police regarding the end of their authority and the family’s wishes for handling the material is not considered to be storage for a scheduled purpose.
Traceability and storage of PM material
Designated Individuals are responsible for ensuring full traceability of all relevant material which is removed, used, stored and disposed of on their premises. Where material is taken or sent off-site, they must ensure that records are kept of where the material is going. Cases should be identified where tissue is expected to be returned to the family.
Disposal is not required to take place on licensed premises. Disposal records should be maintained by the disposing establishment; however independent pathologists should keep their own records regarding the delivery of PM material to an establishment for disposal. Return of material to the originating establishment for repatriation with a body or release for burial or cremation should be recorded in accordance with existing local procedures.
Management of visiting pathologists by establishments
Independent pathologists who carry out licensed activities on HTA licensed premises are acting under the direction of the DI and must adhere to local policies and procedures, which are in place to ensure that the work they carry out meets HTA standards and other regulatory requirements.
Establishments must have systems and procedures in place which govern the activities carried out by independent pathologists, including a policy which covers entry to the premises, induction training and the expectation that local policies and procedures will be adhered to.
DIs of HTA-licensed premises have statutory responsibilities under the Human Tissue Act 2004 and can refuse entry and/or practice to any visitor whom they are not assured will comply with local systems and procedures. The HTA recommends the following steps are taken in relation to the management of visiting pathologists:
- a policy is put in place which covers entry to the licensed premises, training and introduction to the establishment’s operational procedures and the expectation that local policies and procedures will be adhered to;
- the policy sets out the steps to be taken in response to non compliance with policies and procedures;
- written agreements are put in place with each independent pathologist, which document that they will comply with all local policies and procedures in acknowledgement of the regulatory requirements in force under the HTA licence. These agreements should be signed and held by both parties;
- incidents of failure to adhere to local policies or procedure should be managed within the establishments’ existing governance systems to ensure they are escalated and managed appropriately.
Traceability and safety of relevant material
Establishments are responsible for ensuring full traceability of all relevant material which is removed, used, stored and disposed of on their premises.
A system should be put in place to ensure traceability of material retained following PM examination which is transferred in and out of the mortuary. The system should cover the transfer of material for analyses (whether on or off-site) and the identification of cases where material will be returned to the mortuary for repatriation with a body, returned to a family for burial or cremation, or disposal.
The traceability system must be supported by documented standard operating procedures (SOPs) and associated risk assessments which are subject to audit and regular review.
After each PM examination, a record should be made to identify the case number and pathologist along with appropriate details of where each tissue is sent (for example: Hospital X toxicology lab, London), the date the tissue left the mortuary and transportation information (for example, courier receipt number or "taken by pathologist"). The person who completes each entry should be recorded.
Documentation of the receipt of PM material is good practice. For example, on-site personnel can sign and date a log book when material is taken to the laboratory and returned to the mortuary. When material is sent to external establishments it should be accompanied by a detailed list of the shipment; external sites can fax this list back to the mortuary to confirm receipt. The return of material to the mortuary for any reason should also be recorded.
Transport companies, couriers or the pathologist may transport material between the establishment and the referral site. It is recommended that establishments have written agreements with external parties which transport PM material on their behalf which describe the responsibilities of each party and describe any labelling, packaging, record-keeping and transportation requirements (for example, a specified temperature range).
Records of the time and date of disposal should be kept, along with details of where the disposal took place. This information should be contained in a documented procedure on disposal.
Where material is returned to the mortuary for repatriation with a body, return to a family for burial or cremation, or disposal, the date on which the requested action is carried out should be documented. In cases of disposal records must also include the disposal method.
Guidance for independent pathologists
The HTA expects independent pathologists
- to attend training at establishments where they carry out their post mortem activities
- to enter into agreements which confirm that they will adhere to local policies and procedures which cover this work
- to comply with all requirements as outlined at individual establishments.
Independent pathologists should keep their own records about relevant material which is in their possession and when it is taken to establishments for repatriation with a body, return to a family for burial or cremation, or disposal.
For details of enforcement action relating to regulatory non-compliance, refer to the HTA’s enforcement policy HTA-POL-035.
This policy will be reviewed every two years.
Human Tissue Act 2004; The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 ; HTA codes of practice 2009: Consent; Post-mortem examination
*The material may be disposed of rather than being returned to the licensed premises from where it came, and records of disposal should be maintained in order to ensure full traceability. This arrangement should be documented in the agreement between the licensed establishment and the independent pathologist.