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Winter can be an especially challenging time of year for health services. For mortuaries, higher numbers of deaths can pose problems if adequate numbers of refrigerated storage spaces are unavailable.
This document is designed to provide you with information about the Human Tissue Authority (HTA) inspection process, so that you and your staff can prepare for an HTA inspection.
If the deceased person has not indicated their consent (or refusal) to post mortem removal, storage or use of their body or tissue for scheduled purposes, nor appointed a nominated representative, then the appropriate consent can be given by someone in a ‘qualifying relationship’ to the deceased...
EU Directives are being put in place for the coding and import of tissues and cells for human application (HA). These will be transposed into UK law during 2016 and the process of writing the UK Regulations is underway.Copies of these Directives and an overview from the Department of Health (DH...
Establishments that conduct human tissue research under recognised research ethics committee approvals are exempt from being licensed for the storage of relevant material for research under the HT Act 2004.
HTA-licensed establishments in the post mortem sector are required to report incidents (HTARIs), and those in the human application and organ donation and transplantation sectors are required to report serious adverse events or reactions (SAEARs), as part of their licensing with us.
On the 25 March 2015 the HTA published guidance aimed at professionals who work with women who have experienced a pregnancy loss or termination. The guidance sets out what is expected and how women should be involved in decision making about the sensitive handling of pregnancy remains.
The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells. This extended policy will allow collection of blood as a starting material for an ATMP to be performed under either a Tissues and Cells or Blood Establishment Licence.
In 2010, the HTA developed a new licence fee structure which has been in operation since 1 April 2011. The new fee structure followed consultation with stakeholders and is based on the activities of licensing each sector. The fee structure is reviewed each year and fees for the following year...