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News and regulatory updates from the Human Tissue Authority.
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Issue 48 / February 2015

HTA news

Sector news

Anatomy Sector

Human application sector

Post mortem sector

Research sector

HTA news

HTA launches new website

The HTA has redesigned its website as part of our ongoing commitment to enhance the quality and accessibility of the information and guidance we provide to professionals working in areas we regulate, and members of the public who our regulation protects.

The new website offers:

We are currently inviting people to explore the new website and give us feedback, using the feedback button to the bottom-right of the site.

Compliance updates from those licensed under the HT Act 2004 or the Transplantation Regulations 2012

To ensure that we have up-to-date licensing information and assurances of continued suitability to be licensed, we will be requesting compliance updates later this year, as we did in 2013. Read more.

DNA questions

The HTA has reviewed and updated its frequently asked questions about the analysis of DNA under the Human Tissue Act, drawing on questions that have been asked in the course of answering enquiries and visiting establishments.

New Mental Health Act code of practice

A revised code of practice for the Mental Health Act 1983 has been published by the Department of Health.

HTA in the news

The Daily Mirror reported on a grandmother who has given her kidney to her five-year-old granddaughter. The new joint regulator ‘one stop shop’ for regenerative medicine was mentioned in Genetic Engineering & Biotechnology news. Some of the benefits and challenges of regulation were outlined in an online piece by the technical curator of Barts Pathology Museum. West Sussex Trading Standards officers secured a conviction against a licensed establishment that collects and stores stem cells. Finally, it was announced that Rosie Glazebrook, an HTA Board Member, has been appointed as a new member to the General Optical Council – well done Rosie.

Sector news

Anatomy sector

HTA to publish a report on the anatomy sector

In May 2014, the HTA completed its first cycle of site visit inspections for all establishments licensed in the anatomy sector. We will soon publish a summary report (via this newsletter) that will collate the findings and provide an analysis of the trends and themes. In also setting out good practice, we aim to share people’s successes and provide support to others.

Human application sector news

Annual activity data 2014

Thank you to all those who submitted their annual activity data on time. We are currently collating it and chasing up any outstanding submissions, last year we received data from every establishment that was required to submit it.

Human T-lymphotropic virus testing

In 2012 the HTA successfully negotiated with the EU Commission an amendment to the wording of the testing requirements for human T-lymphotropic virus (HTLV). This amendment has been implemented into UK law by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2014. The Regulations came into force on the 15 December 2014. Read more.

Coding and import of tissues and cells

Coding and Import Directives for Tissues and Cells are being put into place in order to implement a single European coding system. This will verify equivalent standards of quality and safety for imported tissues and cells. Read more.

Post mortem sector

Royal College of Pathologists guidance for DIs

As part of a review of guidance on post mortem working, the Royal College of Pathologists’ Death Investigation Group Subcommittee will be developing guidance for Designated Individuals on how they can oversee practice by implementing an audit against RCPath’s standards for coroners’ pathologists in post mortem examinations of deaths that appear not to be suspicious. This could then be used to provide assurance to the HTA on inspections. In the meantime, the HTA has completed a mapping exercise of our standards against those of the Royal College of Pathologists, you can download this here.

Post mortem sector workshops

There are some places available at our March workshop in London on 4 March. We are putting together an interesting and informative programme, which will include a range of HTA and external speakers and an update on HTA policy and guidance. To book your place, please complete the form here.

Mortuary practice: advice on marking bodies

At its last meeting, the HTA’s Histopathology Working Group (HWG) agreed that it was not acceptable practice to write identification details on bodies. The use of labels and wrist/ankle bands is an effective and more respectful way of recording identification details. Guidance on this topic will be included in the next version of the HTA code of practice. In the meantime, mortuary staff are advised that HTA inspectors will be particularly mindful of this when carrying out traceability audits during site visits.

Contingency arrangements for mortuaries during busy periods

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. In addition, we understand that recent guidance from the Chief Coroner on the approach that should be taken to deaths in care homes under deprivation of liberty safeguards may have contributed to increased demand on mortuary space. Please read our guidance about contingency arrangements for mortuaries during busy periods and contact the HTA if you are experiencing difficulties. You can download the Chief Coroner’s guidance here.

Respond to Government consultation on releasing a dead body from hospital

The Department of Health has opened a consultation to seek views on the ‘release of a dead body from hospital’ good practice form. The HTA will be responding to the consultation and we encourage those with an interest in this area to respond too. More here.

Pregnancy loss guidance – update

Revised guidance for doctors/healthcare professionals on sensitive disposal of fetal material following pregnancy loss or termination of pregnancy is currently being finalised and we hope to be able to publish it soon.

October Histopathology Working Group meeting

Minutes of the October meeting of the HWG are now available on the HTA website. The HTA is grateful for the continued participation of members of the Group, whose expertise and advice help ensure that we remain abreast of current issues affecting the sector.

Strategic framework for the efficient management of healthcare estates and facilities

The Department of Health has issued Guidance for NHS organisations on achieving efficiency savings and reducing costs in NHS estates. Part B (page 51) contains a section on decommissioning which we would like to draw to the attention of PM sector DIs.

Research sector

Updated research and human tissue legislation summaries

The Medical Research Council’s Regulatory Support Centre, in collaboration with the HTA, has updated the research and human tissue legislation summaries on consent and licensing. The summaries are on the MRC’s website.

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