Management and traceability of tissue samples retained by independent pathologists

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:

a. 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;

b. 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.

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.

DIs of HTA-licensed premises have statutory responsibilities under the Human Tissue Act 2004 and can refuse entry to any visitor whom they are not assured will comply with local systems and procedures. The HTA recommends DIs put in place the following steps in relation to the management of visiting pathologists:

a. A policy should be 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, including the steps to be taken in response to non-compliance with policies and procedures.

b. Written agreements should be in place with each independent pathologist, signed by both parties, which document that they will comply with all local policies and procedures in acknowledgement of the regulatory requirements in force under the HTA licence.

c. 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

DIs are responsible for ensuring that there are systems which provide for full traceability of all relevant material which is removed, used, stored and or disposed of on their premises. Where material is taken away or sent off-site, DIs must ensure that records are kept of where the material has gone. Cases should be identified where tissue is expected to be returned to the licensed establishment for repatriation with a body or returned to a family for burial or cremation, and steps taken to ensure that this takes place.

The traceability system must be supported by documented standard operating procedures (SOPs) and associated risk assessments which are subject to audit and regular review.

For each PM examination, a record should be made of the tissue retained, the case number and pathologist, along with appropriate details of where each tissue sample 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 X"). The name of the person who completes each entry should be recorded.

Receipt of PM material should also be recorded. For example, staff 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 list of samples. The receiving establishment should send confirmation of receipt to the sending establishment.

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.

Disposal

Disposal is not required to take place on HTA-licensed premises. Disposal records should be maintained by the establishment which carries out the disposal; however, independent pathologists should keep their own records regarding the delivery of PM material to an establishment for disposal.

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.

Guidance for independent pathologists

The HTA expects independent pathologists to:

a. attend training at establishments where they carry out post-mortem examinations;

b. enter into agreements which confirm that they will adhere to local policies and procedures which cover this work; and,

c. 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.