Regulatory alerts

Issued 5 August 2024

Notice for

• Designated Individuals in the Human Application sector 
• Licence contacts in the Organ Donation and Transplantation sector

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about a recent case of Chikungunya in an individual in France.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 2 August 2024, the French Agence de la Biomédecine reported that one autochthonous human case of Chikungunya was confirmed in the Ile de France region.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential Chikungunya transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of 
Chikungunya and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of Chikungunya in Europe can be found here. 

Issued 5 August 2024

Notice for

• Licence Holders, Designated Individuals and Persons Designated in the human application sector

This alert is being issued by the Human Tissue Authority (HTA) following last week’s National Patient Safety Alert about the shortage of Human Albumin 4.5% and 5% dose vials.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

The alert includes a list of actions to be completed as soon as possible and not later than 07 August 2024: CAS-ViewAlert (mhra.gov.uk)

Issued 15 July 2024

Notice for  

• Designated Individuals in the Human Application sector  
• Licence contacts in the Organ Donation and Transplantation sector  

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of West Nile Virus (WNV) in individuals in Spain.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 15 July 2024, the National Transplant Organization reported that five autochthonous human cases of WNV were confirmed in the province of Seville (Andalucia region, in the South of Spain).

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential WNV transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of  
WNV and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of WNV in Europe can be found here.  

Issued 15 July 2024

Notice for

•    Designated Individuals in the Human Application sector  
•    Licence contacts in the Organ Donation and Transplantation sector  

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of Dengue in individuals in France.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 4 July 2024, the Agence de la Biomédecine (France) reported that an autochthonous case of Dengue has been confirmed in the department of Hérault (34), Occitanie region.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential Dengue transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of  
Dengue and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of Dengue in Europe can be found here.  

Issued 02 April 2024

Notice for

• Licence contacts in Organ Donation and Transplantation Sector
• Living Donor Coordinators 

Scope

This alert is being issued by the Human Tissue Authority to notify licensed establishments about the Supply of Information about Transplants Regulations 2024 (‘Regulations’) , which came into force on 1 April 2024.

Issue

The Regulations make it a statutory requirement for all ‘relevant clinicians’ in England, Wales and Northern Ireland who work closely with patients that need, or have received, an organ transplant to report the following information to the HTA:

• if they have a reasonable suspicion that an organ donation and transplantation-related offence may have been committed under the Human Tissue Act or Modern Slavery legislation, and 
• if they are made aware that a patient has received an organ transplant outside the UK.

Failing to report under the Regulations is an offence, and clinicians risk criminal charges amounting to a fine for failing to report, or an unlimited fine for providing false or misleading information.

Action taken by the HTA

The HTA has issued this alert to all licensed establishments that may be in contact with ‘relevant clinicians’ who are required to report information under the Regulations. It has also prepared guidance to support relevant clinicians, which includes what information should be reported, how to submit a report and what to tell patients.

Action for establishments

All licensed establishments within the Organ Donation and Transplantation sector must:

• review relevant policies and procedures to ensure they align with the Regulations, and 
• notify the relevant clinicians within their establishment of the statutory duty to report.

Where relevant, licensed establishments should share this regulatory alert with its referring centres.

 

Issued to DI and corporate licence holders in the Anatomy sector

Storage of a body for anatomical examination following changes to the system in England and Wales for certifying cause of death

With effect from 9 September 2024, a new system is being introduced in England and Wales to provide independent scrutiny of deaths. All deaths not investigated by a coroner will be reviewed by NHS medical examiners.

The main change is that attending medical practitioners must share the certificate and proposed cause of death with a medical examiner, which will be scrutinised before submission to the registrar. Significantly, the attending practitioner’s certificate will not have any legal status until confirmed by a medical examiner.

The new system also enables a senior coroner to refer a case to a medical examiner in exceptional circumstances where there is no attending medical practitioner, or one is not available within a reasonable time. In such circumstances, the medical examiner may certify the death by completing a medical examiner certificate.

An amendment to the Human Tissue Act 2004 will be brought into force. This will allow for the lawful storage of a body of a deceased person for use for the purpose of anatomical examination if done with appropriate consent, and after the confirmation of the cause of death by a medical examiner or the issue by a medical examiner of a certificate of the cause of death.

Our Code Practice on Anatomical examination makes it clear that the lawful storage of a body for anatomical examination requires appropriate consent to be in place and that the death certificate is signed. The medical examiner system does not change the fundamental system that death certificates must be duly signed. 

We will update our Code of Practice when it is next revised.

issued 13 August 2024

To all Designated individuals and License Holders 

We will adopt a new approach to regulation from September 2024 when most on-site assessments of HTA post mortem licensed premises will be taking place without notice. This is to maintain compliance in the post mortem sector.  

This is being driven by the increased severity of shortfalls we are finding and, in some cases, a failure to take corrective and preventive action following inspection.
Please be prepared to make documents available to our Regulation Managers on request (list below).

We will continue to work with you, through the inspection process, to help you comply with published standards but we ask you to be fully prepared for
our Regulation Managers.

The time between inspections may vary, in some cases it may be sooner than you expected. HTA attendance on site will always be at a reasonable time to observe working practices and procedures.

If you have any questions about this, please contact us at: Licensing@hta.gov.uk

Please have these documents ready for your inspection:

Consent

Adult

• Example (blank) hospital PM consent form
• PM consent SOP
• PM consent policy
• PM Information provided to the family of the deceased 

Perinatal/Paediatric

• Example (blank) hospital PM consent form 
• PM consent SOP
• PM consent policy
• PM Information provided to the family of the deceased 

Governance and Quality

SOPs

• Admission of bodies (including same/similar names, unknown bodies and out of hours)
• Release of bodies (including same/similar names and out of hours)
• PM examination (including responsibilities of APTs and pathologists, management of high-risk cases)
• Evisceration and reconstruction
• Viewing of the deceased (including out-of-hours and on the maternity ward if it is covered by the licence)
• Storage arrangements for bodies
• Condition checking of bodies
• Long-term storage of bodies
• Transfer of bodies internally (e.g. for PMCT, contingency storage or the return of babies/foetuses to the maternity ward for viewing)
• Transfer of bodies externally (e.g. for PM examination or contingency storage)
• Contingency plan
• Contingency storage arrangements
• Cleaning and Decontamination
• Cleaning records (if these cannot be reviewed onsite):
• PM room(s)
• Body store(s)
• Fridges/freezers
• PPE
• Retention of tissue/organs following a PM examination (including record keeping and traceability)
• Disposal of tissue (including blocks and slides), which ensures disposal in line with the wishes of the deceased’s family
• Transfer of organs and tissue (including blocks and slides) off site to other establishments (including confirmation of receipt) and to pathologists who may review tissue slides at home.
• Records management (including document control, version control, deviations, and staff acknowledgement)
• Lone working
• Mortuary security and access (including a list of people who have access by job role)
• Access to the mortuary and supervision of non-mortuary staff, contractors and visitors
• Incident reporting and management, including HTARIs
• Incident log for last 24 months for all mortuary incidents and any incidents from other areas covered by the licence e.g. in maternity). 

Policies covering

• Data protection
• Confidentiality
• Freedom of information
• Public disclosure (whistleblowing)
• Duty of candour
• Sudden Unexpected Death in Infants and Children (SUDIC) policy/protocol (if applicable) 

Meeting Minutes

Minutes of the last four

• mortuary staff meetings
• governance meetings relating to licensed activities

Audits

• Audit schedules for licensed activities, from this year and last year (including types and frequency of audits)
• The last 2 audit reports for traceability of tissue (including supporting information to demonstrate any non-conformances have been addressed)
• The last 2 audit reports for traceability of bodies (including supporting information to demonstrate any non-conformances have been addressed)
• The last 2 mortuary security/access audits (including any supporting information to demonstrate any non-conformances have been addressed). 

Risk Assessments

Relating to:

• Admission, release and transfer of bodies
• PM examination
• Specimens
• Security
• Lone working
• Viewings
• Body storage
• Risk assessments relating specifically the HTARI categories
• Details of any risks included on the establishment’s organisation risk register 

Training Records (if these cannot be reviewed onsite):

• Mortuary staff training records (including mandatory training)
• Mortuary staff competency records
• Mortuary staff appraisal records
• Mortuary staff induction (if there is relatively recent example to review)
• Porter training records
• Porter competency records
• Training records of staff who seek consent for adult PM examinations
• Training records of staff who seek consent for paed/perinatal PM examinations
• Competency records of staff who seek consent for adult PM examinations
• Competency records of staff who seek consent for paed/perinatal PM examinations 
• Training records for any other staff completing activities under the licence (e.g. funeral directors admitting bodies out of hours, or bereavement staff carrying out viewings)
• Competency records for any other staff completing activities under the licence (e.g. funeral directors admitting bodies out of hours, or bereavement staff carrying out viewings) 

Service Records (if these cannot be reviewed onsite):

For:

• Fridges (including for any contingency storage units)
• Freezers (including for any contingency storage units)
• Trolleys/Hoists
• PM table
• Saws 

For each site, if applicable

• Most recent PM room ventilation report showing number of air changes per hour ac/h) for each PM room, if applicable (if this cannot be reviewed onsite) 

For information from the Human Tissue Act 2004

Duty of the designated individual

It shall be the duty of the individual designated in a licence as the person under whose supervision the licensed activity is authorised to be carried on to secure

(a) that the other persons to whom the licence applies are suitable persons to participate in the carrying-on of the licensed activity,

(b) that suitable practices are used in the course of carrying on that activity, and

(c) that the conditions of the licence are complied with.

SCHEDULE 5 Powers of inspection, entry, search and seizure

Inspection of statutory records

1(1) A duly authorised person may require a person to produce for inspection any records which he is required to keep by, or by virtue of, this Act.

(2) Where records which a person is so required to keep are stored in any electronic form, the power under sub-paragraph (1) includes power to require the records to be made available for inspection

(a) in a visible and legible form, or

(b) in a form from which they can readily be produced in a visible and legible form

(3) A duly authorised person may inspect and take copies of any records produced for inspection in pursuance of a requirement under this paragraph

Entry and inspection of licensed premises

2(1) A duly authorised person may at any reasonable time enter and inspect any premises in respect of which a licence is in force

(2) The power in sub-paragraph (1) is exercisable for purposes of the Authority’s functions in relation to licences

Issue date 28 March 2024

Update to all establishments licensed under the Post Mortem Sector

Scope
This update is being issued by the Human Tissue Authority (HTA) to inform establishments undertaking activity under a Post Mortem licence the guidance for the submission and completion of HTA Reportable Incidents has been reviewed and updated.
Please circulate this information to staff within your establishment undertaking activities under the Post Mortem Licence.

Issue
Due to the increased severity and quantity of incidents reported. We have completed a thorough internal review of the wording of, and guidance associated with the reporting of incidents to the HTA.
This update is to ensure that all establishments are aware of the updated guidance and review and update policies and procedures instructing staff on the reporting of incidents to reflect the current guidance.

Action taken by the HTA

• The addition of a definition of reportable incidents
• Corporate Licence Holder contacts will be copied into initial emails and incident closure notices.
• HTA may share information pertaining to incidents with other regulators.
• Information for establishments on the completion of the incident summary to include immediate corrective actions.
• A Decision tree to support the reporting of incidents relating to Accidental Damage during Post Mortem Examination.

Actions for establishments

• Review establishment SOPs and Policies to ensure these reflect the updated guidance.
• Share the guidance with all staff and persons designated undertaking activity under the license during staff meetings.
• Remove any hard copies of the previous guidance from circulation.

This information is available on the HTA website at:  HTARI Guidance for establishments

Issued 26 January 2024
 
Notice for all licensed establishments.
 
Licence fees for the 2024 to 2025 financial year

Dear colleague,

The Human Tissue Authority (HTA) has published licence fee levels for the 2024 to 2025 business year. The new fees can be found on our website.

As indicated to establishments in December, the HTA needs to make a notable, above inflation increase to license fees in 2024 to 2025. The licence fees for 2024 to 2025 reflect the increased pressure faced by HTA of rising costs amid unprecedented increases in inflation, as well as a change in funding policy from our sponsor department, the Department of Health and Social Care (DHSC).

As an executive agency of the DHSC, we are funded in part from Grant-in-Aid from DHSC and devolved administrations, but the main source of resourcing is derived through licence fees charged to licensed establishments.

The HTA will be writing to the human application establishments to request purchase orders prior to issuing invoices in April 2024. In the autumn of 2024 a further request will be made to establishments in the other five sectors.

If you have any questions regarding HTA licence fees, please email: finance@hta.gov.uk.

Issued 21 December 2023

Notice for  
•    Designated Individuals in the Human Application sector 

Scope
This alert is being issued by the Human Tissue Authority (HTA) and includes information about OriGen Accessory Sets with yellowed syringes.

The HTA has been made aware of a Medical Device Recall/Field Safety Notice issued by OriGen into the following issue.

RF-T15 assembly that had a yellowed syringe.  It was determined that the yellowed syringe was moulded with a new polypropylene resin that is not rated for gamma sterilization.

On 19 December 2023 OriGen quarantined all impacted lots of syringe assemblies and syringes and OriGen has initiated a medical device recall/field safety notice of the impacted lots.

Affected Lots
Part/Model # Part Description Lot(s)
•    RF-T15 6ml syringe with a female luer with 15cm sealed SCD tubing.
Lot Numbers:
V23276 (Please note that, as confirmed by Origen on 4 Jan 2024, Lot number V23276 is not affected and should be excluded from the list.)
V23277
V23278
V23639

•    15-RF60-T 60ml syringe on a female luer with 15cm sealed SCD tubing.
Lot number: V23281

Action taken by the HTA
The HTA has issued this alert to all HTA-licensed establishments that handle tissues and cells in the human application sector for wider awareness. 

Actions for establishments 
Users of any of these products are advised to contact OriGen for further advice and guidance and to review the Field Safety Notice issued by the company. 
Users are also advised to review Medicines and Healthcare products Regulatory Agency’s (MHRA) for further information and updates.

https://www.gov.uk/drug-device-alerts

Issued 4 August 2023 

Notice for  

•    Designated Individuals in the Human Application sector  
•    Licence contacts in the Organ Donation and Transplantation sector  

Scope 

This alert is being issued by the Human Tissue Authority (HTA) and includes information about a recent case of West Nile Virus (WNV) in Bordeaux, France 

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice. 

Issue 

On 1 August 2023, the L’Agence Régionale de Santé Nouvelle-Aquitaine (France) issued a press release of the first autochthonous human case of WNV infection in a person residing in Bordeaux (Gare district), in the department of Gironde. 

Action taken by the HTA 

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of WNV cases in areas not normally associated with this virus. 

Actions for establishments 

This alert is to ensure that all establishments are aware of the recent reports of WNV and can review their donor selection and evaluation procedures accordingly. 

Up-to-date information on cases of WNV in Europe can be found here.  

Issued 1 February 2023 

Notice for  

• Licence contacts in the Organ Donation and Transplantation sector  

• Designated Individuals in the Human Application sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about microbial contamination/discolouration, particulate matter within solution and leakage of bags of Carnamedica Belzer UW® Cold Storage and Machine Perfusion solutions, imported by Bridge to Life.  

 
Issue

The HTA has been made aware of an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) and Bridge to Life into the following issues: 

- Discolouration of solution / microbial contamination and leaking bags 

    - Carnamedica Belzer UW® Cold Storage Solution, 1L size / BUWC1 

    - Carnamedica Belzer UW® Machine Perfusion Solution MPSC 

- Particles in solution 

    - Carnamedica Belzer UW® Cold Storage Solution, 2L size / BUWC2 

On 20 January 2023, Bridge to Life implemented a temporary voluntary suspension of supply of specific manufacturing lots of Belzer UW Cold Storage Solution and Belzer UW Machine Perfusion Solution to the UK. 

The manufacturer is conducting an investigation on the following known impacted lot numbers: 010722, 022422, 030122, 030222, 030322, 030722, 061022, 081222, 090122, 110822,110922, 123021. The safety investigation is on-going - lot numbers not listed as impacted cannot be guaranteed to be unaffected by the issues identified to date. Findings will be reported to MHRA for review. Safety related communication on how to minimise the associated risk has been published on the MHRA website.   

Action taken by the HTA 

The HTA has issued this alert to all HTA-licensed establishments that handle human organs, tissues and cells in the solid organ transplantation and human application sectors for wider awareness. 

Actions for establishments 

Users of any of these products are advised to contact Bridge to Life for further advice and guidance and to review the Field Safety Notice issued by the company. A link to the Field Safety Notice is provided below: 

Medicines and Healthcare products Regulatory Agency (filecamp.com)  

Users are also advised to review the information published by the MHRA in relation to this matter and to follow the guidance that has been issued regarding reporting of incidents. A link to the MHRA’s guidance is provided below:  

Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid; DSI/2023/002 - GOV.UK (www.gov.uk).  

Issued 20 December 2023

Notice for Designated Individuals and Corporate Licence Holders in the Human Application Sector
 
Annual activity data collection

On Monday 8 January 2024, the HTA will commence collecting annual activity data from all establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended).  Submission of this data is a requirement under the standard conditions of your licence. Failure to submit data before the deadline may result in regulatory action by the HTA.
 
Data must be submitted via the HTA Portal between 9.00 am Monday 8 January 2024 and 5.00 pm on Friday 29 March 2024.

How to submit your data

You will need to submit your data directly on the HTA Portal.

We strongly recommend that you read our guidance on how to submit your data. The guidance sets out the questions that form this year's submission and step-by-step instructions on how to complete your data submission.

The questions that form this year’s data collection may be found under the section “Annual Activity Data Questions”
 
If you did not carry out any licensable activities during 2023, you will still need to submit a data return before the deadline. If you wish to vary or revoke any part of your licence, please email licensing@hta.gov.uk at your earliest convenience.

For further information, please email licensing@hta.gov.uk or call 020 7269 1900.
 

Issued 13 December 2023 

Notice for Living Donor Coordinators and Independent Assessors

Mandatory IA refresher training 

There is an increased risk posed by the growing threat of human trafficking for the purpose of obtaining organs for transplantation, which has highlighted the need for additional training. We are inviting Independent Assessors to attend one mandatory training session.  

The training sessions will be delivered virtually via Teams. These will be co-delivered by the HTA and the Modern Slavery and Child Exploitation Partnership & Training team in the Metropolitan Police. 

Each session will cover the following key topics: 

• Understanding legal changes 

• Higher risk factors and potential red flags to look out for during IA interviews 

• Interviewing non-UK resident donors 

• Question and answer session. 

Training session options 

We have scheduled three Teams training sessions. Each IA must attend one of these sessions: 

• 29 January 2024 – 13:00 – 14:15 

• 15 February 2024 – 10:00 – 11:15am 

• 23 February 2024 – 9:30 – 10:45am 

We will be sending out a survey for you to confirm your attendance at one of the sessions. 

If you have any questions about the training sessions, or you know you cannot attend any of these sessions, please contact us at transplants@hta.gov.uk  

Updated guidance on evidence of relationship for Independent Assessor (IA) interviews 

Acceptable evidence of relationship 

We are no longer able to accept affidavits and family trees as evidence of a claimed relationship. 

Acceptable evidence includes but is not limited to: 

• Birth certificates, adoption certificates, marriage certificates, civil partnership certificates. 

• Proof of joint residence, such as utility bills or mortgage/rent statements in joint names 

• Photographs which clearly span the duration of the relationship and where both donor and recipient are in the photographs; 

• Text/WhatsApp/email/social media messages spanning the duration of the relationship, where appropriate.  

If the donor and recipient are unable to provide any of the above, please contact the Living Organ Donation team for advice at transplants@hta.gov.uk  

Recording the documents seen in IA reports 

IAs are reminded to clearly state in their reports the documents which have been seen in terms of both ID and evidence of claimed relationship. 

Example: 

For proof of ID, I have seen UK passports for both the donor and recipient. 

For evidence of relationship, I have seen a birth certificate which shows the donor is the recipient’s father. 

In addition I have seen 10 photos spanning a period of 15 years between 2008 and 2023. These photos include both the donor and recipient at various different social settings including at a party and on holiday in Greece. The donor and recipient are clearly identifiable in these photos. 

Triangulation of ID and evidence of relationship documents 

In order to streamline processes and prevent delays, it is advisable that Living Donor Coordinators (LDCs) ensure the ID and evidence of relationship documents are available and view these themselves in advance of the IA interviews. This mitigates the risk of delays in decision making due to incomplete or inadequate information being presented at a late stage. This applies to every living organ donation case.  

Virtual interviews - Where possible, IAs need to be provided with the ID and evidence of relationship documents ahead of the interview. This must be done in line with internal hospital data protection policies.  

Non-UK resident donors - Units need to ask for, and view, all ID and evidence of relationship documents prior to considering a letter of support for a visa. Visas should not be supported where clear evidence of a genetic or close personal relationship with the intended recipient in the UK cannot be provided. 

UK Visas and Immigration guidelines make clear that a genetic relationship is where the donor is a blood relative to the identified recipient in the UK. Close personal relationships would typically include spouse, partner, or close friend. It would not extend to relationships established via media/social media campaigns. 

Update regarding COVID risks and the assessment of living organ donations. 

After careful consideration and discussion with units, we have decided to update our previous guidance on COVID.  

It is no longer mandatory for transplant units and IAs to include specific confirmation of the donor’s understanding of the risks associated with COVID in referral letters or IA reports. 

Units are now expected to follow their own procedures in relation to describing COVID risks to donors and recipients. 

Issued 10 November 2023

Notice for the following role holders within the Post Mortem Sector: 
 • All Designated Individuals  
• All Corporate Licence Holder Contacts 
• All Persons Designate 

Scope

This update is being issued by the Human Tissue Authority (HTA) to provide guidance on mortuary capacity issues. 
Please circulate this information to staff within your establishment undertaking activities under the Post Mortem Licence. 

Issue 

Mortuary capacity issues and service pressures that may require additional capacity. 

Actions for establishments 

Licensed establishments are encouraged to revisit existing HTA Guidance on contingency storage arrangements for the deceased: 
https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-contingency-storage-arrangements 

If additional storage is required, please inform the HTA of this by email to: Licensing@hta.gov.uk  

In particular, the following information should be supplied to the HTA: 

• Address and postcode the unit will be located 
• Number of additional capacity spaces (fridge and freezer) 
• Proximity to the mortuary 
• Who will have access (APTs / porters / FDs etc) and how will transfer to this unit be completed 
• Will the deceased be released directly to funeral directors from this site / unit (if applicable) 
• Details of security arrangements in place and whether there is any oversight of activity in this area by the public 
• Temperature monitoring arrangements 
• Traceability arrangements – bodies of same / similar name and location recording 
• Approximate time it will be in use for  

An extension of storage capacity and location(s) increases the risks which are associated with licensable activities. Establishments should therefore undertake risk assessments, ensure sufficient training is provided to staff and ensure current SOPs, policies and procedures reflect current practice. In respect of the risk of release of the wrong body, establishments should review existing guidance: https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/release-wrong-body-incidents-post-mortem-sector 

Where additional storage will be off-site and bodies are being held for a scheduled purpose, a HTA licence is required. Guidance on the HTA’s emergency mortuary licensing can be found at: https://www.hta.gov.uk/guidance-professionals/licences-roles-and-fees/licensing/applying-our-licences/emergency-mortuary 

Establishments are reminded of their obligations to report to the HTA any incidents that fall within the categories outlined in our guidance that can be found at: https://www.hta.gov.uk/guidance-professionals/regulated-sectors/post-mortem/post-mortem-hta-reportable-incidents-htaris 
 

Issue date 18 July 2023

Scope 

This update is being issued by the Human Tissue Authority (HTA) to provide an update and guidance on living organ donation procedures. 

Background

We are facing an increased risk of human trafficking for organ removal, necessitating heightened vigilance and adherence to robust processes.

Revised Guidance for transplant teams and Independent Assessors will be published by the end of 2023, and mandatory refresher training, including information on trafficking indicators, will be implemented for assessors by April 2024.

There has been a rise in complex cases with remote donor-recipient relationships, often lacking sufficient evidence. Delays may occur, so adherence to guidance is crucial.

Advice for Independent assessor

Please read this update provided by the Head of Regulation for Organ Donation and Transplantation.

Issue Date 18 July 2023

Scope 

This update is being issued by the Human Tissue Authority (HTA) to provide an update and guidance on living organ donation procedures. 

Background

We are facing an increased risk of human trafficking for organ removal, necessitating heightened vigilance and adherence to robust processes.

Revised Guidance for transplant teams and Independent Assessors will be published by the end of 2023, and mandatory refresher training, including information on trafficking indicators, will be implemented for assessors by April 2024.

There has been a rise in complex cases with remote donor-recipient relationships, often lacking sufficient evidence. Delays may occur, so adherence to guidance is crucial.

Advice for living donation coordinators

Please read this update provided by the Head of Regulation for Organ Donation and Transplantation.

Issue date 13 July 2023 

Scope 

This update is being issued by the Human Tissue Authority (HTA) to provide advice and guidance on managing storage facilities during a heat wave.  

Please circulate this information to staff within your establishment undertaking activities under the post mortem licence.  

Background  

Last summer, we saw temperatures in the United Kingdom rise to over 40°C.  

Between July and August 2022, there were 15 reports of ‘Major Equipment Failure’ in the post mortem sector directly associated with the heat waves. Where temperatures exceed the normal working range of most fridge and freezers, especially for extended periods of time, there are risks of the fridge and freezer units becoming overworked leading to failure. In such scenarios, there is a risk to establishments’ ability to maintain the dignity of the deceased. 

Advice for establishments 

Licensed establishments should consider the following to minimise the risk of equipment failure:  

• Monitor room temperatures where fridges and freezer units are located Where  temperatures  exceed normal working conditions, cooling systems such as air conditioning units, room cooling equipment and fans should be considered.
• Where compressor units are internal, establishments should ensure  there is sufficient air flow around them. Consider an alternative location, allowing more air flow if possible. 
• Where there is potential for external compressor units to be in direct sunlight the use of reflective coverings should be explored.  
• Regular temperature monitoring will help to identify trends and the extent of any variations in storage temperatures. 
• Establishments should check their temperature alarm triggers to ensure they are set correctly and there is a process in place if they are activated outside of usual working hours or shifts.  The settings should ensure that the condition of bodies and tissue is appropriately preserved.  
• The frequency of alarm testing may be increased, and this testing should also cover out of hours call outs.  
• Temporary storage facilities may be less efficient at maintaining internal temperatures, especially in hot weather. Where storage capacity is an ongoing issue, this should be escalated to the relevant Trust, Health Board or Local Authority. 
• Establishments are advised to contact their servicing and maintenance suppliers and/or internal estates departments to discuss arrangements during periods of hot weather.  
• Establishments should consider entering into mutual aid agreements with neighbouring organisations in order to provide and obtain support in case of capacity shortages. 

Establishments should report to the HTA any incidents that fall within the categories outlined in our guidance.  It can be found here: https://www.hta.gov.uk/guidance-professionals/regulated-sectors/post-mortem/post-mortem-hta-reportable-incidents-htaris   

Issue date 30 June 2023 

Updated versions of the HTA’s Codes of Practice (except Code F, Part two: Deceased organ and tissue donation which was published on 1 June 2023), have been published including new Directions.  

Minor changes have been made to the Codes of Practice to ensure they accurately reflect recent legislative changes and policy updates – such as the introduction of Deemed Consent in Northern Ireland – and include updated references and other minor changes. 

An updated version of Code F, Part two: Deceased organ and tissue donation has been published, including new Directions.  

Code F, Part two was approved by Parliament and reflects the introduction of deemed consent for deceased organ and tissue donation for the purpose of transplantation in Northern Ireland. 

Updated 13 June 2023: Due to technical difficulties, circulating the sector questionnaires to individual establishments has been delayed. This is expected to be resolved shortly and we have extended the deadline to complete and submit to 7 July.

Issued 23 May 2023

Notice for

Corporate Licence Holder contacts, Designated Individuals, Named Contacts and Persons Designated.

Scope

We will be carrying out a data collection exercise from licensed establishments.

Establishments in the Anatomy, Post-Mortem, Research, Public Display and Organ Donation and Transplantation sectors will be asked to complete a short questionnaire with simplified answer options. The responses we receive will inform our assessment allocation and prioritisation. The data we receive will also inform our understanding of risks and activities within establishments and sectors. 

In the Human Application sector, we will be requesting information relating to preparation processes for which a Preparation Process Dossier (PPD) has not been submitted. Establishments will not be required to submit PPDs as part of this exercise. Establishments that are licensed to store relevant material for use for a scheduled purpose under the Human Tissue Act 2004 will be asked to complete a Research data collection questionnaire.

Actions for establishments

The invitation to complete the questionnaire will be sent via email to Designated Individuals and Named Contacts from 1 June 2023. We require responses to be submitted via the HTA portal by 30 June 2023 at the latest. 

It is a requirement under licensing conditions to report this data to us. We advise that all Designated Individuals and Named Contacts check that they are registered on the HTA portal with their current email address.

Action by the HTA

For each sector licensed under the Human Tissue Act 2004, we will analyse the data and provide a high-level overview of findings. For relevant establishments in the Human Application and Organ Donation & Transplantation sectors, this exercise will ensure our licensing records are accurate and up to date and we may contact you for further information

Issued 6 April 2023

Notice for  

• Licence contacts in the Organ Donation and Transplantation sector  
• Designated Individuals in the Human Application sector 

The Medicines and Healthcare products Regulatory Agency (MHRA) has published an update on defects identified with Belzer solutions, manufactured by Carnamedica (UK Responsible Person Bridge to Life). Please read details here:

https://www.gov.uk/drug-device-alerts/belzer-uw-cold-storage-solution-and-belzer-mps-uw-machine-perfusion-solution-manufactured-by-carnamedica-ukrp-bridge-to-life-contamination-of-fluid-update-to-dsi-slash-2023-slash-002-dsi-slash-2023-slash-005

Issued 31 January 2023

We’ve published an updated version of our Anatomy sector Licensing Standards and Guidance

The updated version was informed by an internal review and engagement with external stakeholders.

In making these updates, we have also taken into account the revisions that we made to the guidance that supports our Post Mortem sector licensing standards in 2022.

The updated guidance includes the following:

• staff training (C2 and GQ3 standards)
• expectations for documents and governance aspects (GQ1 standards)
• control and monitoring of access (GQ1 and GQ2 standards)
• having due regard to other legislation (GQ4 standards)
• examples of adverse events (GQ5 standards)
• examples of risk assessments (GQ6 standards)
• premises suitability and security (PFE1 standards)
• storage arrangements to maintain the dignity of the deceased (PFE2 standards)

Please note that we are not making any changes to the standards themselves, which are brought into force by our Codes of Practice and have to be approved by Parliament.

Issued 10 January 2023 

Notice for the following role holders within the Post Mortem Sector: 

• All Designated Individuals  

• All Corporate Licence Holder Contacts 

• All Persons Designate 

Scope

This update is being issued by the Human Tissue Authority (HTA) to provide advice and guidance on managing mortuary capacity issues. 

Please circulate this information to staff within your establishment undertaking activities under the Post Mortem Licence. 

Issue 

Excess deaths within the United Kingdom has inevitably resulted in mortuary capacity issues and service pressures. 

Actions for establishments 

Licensed establishments are encouraged to revisit existing HTA Guidance on contingency storage arrangements for the deceased: 

https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/guidance-contingency-storage-arrangements 

If additional storage is required, please inform the HTA of this by email to: Licensing@hta.gov.uk  

In particular, the following information should be supplied to the HTA: 

• Address and postcode the unit will be located 

• Number of additional capacity spaces (fridge and freezer) 

• Proximity to the mortuary 

• Who will have access (APTs / porters / FDs etc) and how will transfer to this unit be completed 

• Will the deceased be released directly to funeral directors from this site / unit (if applicable) 

• Details of security arrangements in place and whether there is any oversight of activity in this area by the public 

• Temperature monitoring arrangements 

• Traceability arrangements – bodies of same / similar name and location recording 

• Approximate time it will be in use for  

An extension of storage capacity and location(s) increases the risks which are associated with licensable activities. Establishments should therefore undertake risk assessments, ensure sufficient training is provided to staff and ensure current SOPs, policies and procedures reflect current practice. In respect of the risk of release of the wrong body, establishments should review existing guidance: https://www.hta.gov.uk/guidance-professionals/guidance-sector/post-mortem/release-wrong-body-incidents-post-mortem-sector 

Where additional storage will be off-site and bodies are being held for a scheduled purpose, a HTA licence is required. Guidance on the HTA’s emergency mortuary licensing can be found at:  https://www.hta.gov.uk/guidance-professionals/licences-roles-and-fees/licensing/applying-our-licences/emergency-mortuary 

Establishments are reminded of their obligations to report to the HTA any incidents that fall within the categories outlined in our guidance that can be found at: https://www.hta.gov.uk/guidance-professionals/regulated-sectors/post-mortem/post-mortem-hta-reportable-incidents-htaris 

Issued 28 September 2022

Notice for 

•    Designated Individuals in the Human Application sector 
•    Licence contacts in the Organ Donation and Transplantation sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about locally-acquired Dengue cases in France.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 26 September 2022, the Agence Nationale de Securité du Médicament (ANSM) in France created an alert on the EU Rapid Alert on Substances of Human Origin platform detailing 36 locally-acquired human cases of Dengue, as follows:

In Occitania region:

- One case in the city of Perpignan, Pyrénées-Orientales with onset of symptoms in mid-June 2022.

- Four cases in the city of Andrest (situated close to Tarbes) and in the city of Rabastens (30 km from Toulouse), Hautes-Pyrénées with onset of symptoms in July-August 2022.

- Four cases in the city of Salvetat Saint Gilles (situated close to Toulouse) with onset of symptoms in the second half of August 2022.

In Provence-Alps-Cote d'Azur region:

- Six cases in the city of Fayence, Var with onset of symptoms between end of June and end of July 2022.

- Twenty-one cases in the cities of St Jeannet, Gattières, and Gaude (situated close to Nice), Alpes-Maritimes with onset of symptoms in August-September 2022.

The outbreaks in the cities of Perpignan and in Fayence are now considered to be over. For the other three outbreaks, additional cases might be detected.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of these cases.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of Dengue and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of Dengue in Europe can be found on the ECDC website.

Issued 14 November 2022

Organ transplantation – quality and safety update

An updated version of The Quality and Safety of Organs Intended for Transplantation: A documentary framework has been published, to include new directions. 

Under the new directions, where an organ is sent to an establishment for assessment or recovery purposes and a mechanical perfusion device is used, the establishment under whose licence this activity takes place must record and store any organ characterisation and traceability data generated by the establishment, for a period of 30 years. 

Issued 4 October 2022

We’ve published an updated version of Post-mortem Examination Licensing Standards and Guidance.

We completed a thorough internal review of the wording of, and guidance associated with the following overarching licensing standards: GQ1, GQ2, GQ4, GQ6, T1, PFE1, PFE2 and PFE3.

These standards are broadly concerned with effective control and monitoring of access, storage arrangements that maintain the dignity of the deceased, and oversight of visitors and contractors.   

The updates are as follows: 

Governance and quality systems

• GQ1a): additional guidance on procedures taking account of both standard and out-of-hours arrangements. 

• GQ1b): additional guidance emphasises that bodies should not be held in unrefrigerated conditions for prolonged periods of time to ensure dignity, safety and to preserve evidence of cause of death. 

• GQ1d): includes guidance relating to regular reviews of SOPs. 

• GQ2a): includes guidance on auditing of CCTV as well as records of mortuary access. 

• GQ2b): includes guidance on implementing processes to ensure feedback of audit findings and embedding of up- to- date procedures. 

• GQ4a): includes guidance on record management procedures to include records of access to the mortuary. 

• GQ6a): Additional guidance to include risks to security within risk assessments.  

Premises, facilities and equipment

• PFE1d): Additional guidance ensuring security arrangements are robust with effective mechanisms to strictly control access. CCTV is acknowledged to be an important security measure but should not be used in a way that compromises dignity. Systems should prevent inappropriate access or use of of images. 

• PFE1e): Additional guidance on monitoring and documenting of entry into the mortuary or body storage facility; DI oversight in respect of lone working arrangements; and auditing of records relating to mortuary access. 

• PFE2g): Guidance added to emphasise that shrouding practices should preserve the dignity of the deceased. 

Issued 17 February 2021

Notice for 

•    Designated Individuals in the Human Application sector 

Scope

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application to raise awareness of the potential contamination risks to cryopreserved stem cells.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

A Field Safety Notice (FSN) has been placed on the Medicines & Healthcare products Regulatory Agency’s (MHRA) website.

The notice concerns the leaking of graft into the "pocket” in the seam of the stem cell transplant freezing bag when the graft was mixed. There was also a hole in the pocket from which the graft leaked out and which posed a risk of contamination to the graft. A “pocket” was observed in other bags of the same LOT.

Action taken by the HTA

The HTA has issued this alert to ensure that all HTA-licensed establishments in the human application sector which undertake cryopreservation of haematopoietic stem cells are aware of the field safety notice.

The FSN can be found on the MHRA's website.

The product identified in the FSN is as follows:

Miltenyi CryoMACS Freezing Bag 750, Product code 200-074-403, LOT 720070537, EXP 2023-06-29.

Actions for establishments

Establishments using the product listed above should contact Miltenyi Norden Biotec AB, Sweden for further information:

• Miltenyi Biotec Norden AB, Medicon Village, Scheeletorget 1, 223 81 Lund, Sweden
• Phone: +46 46 280 7280
• Email: macs@miltenyibiotec.se

Please contact the HTA on 020 7269 1900 or email enquiries@hta.gov.uk if you would like any further advice on the above notice.

Issued 21 October 2020

Notice for 

•    Designated Individuals in the Human Application sector 
•    Licence contacts in the Organ Donation and Transplantation sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about a recent case of West Nile Virus (WNV) in an individual in the Netherlands.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 21 October 2020, The Netherlands - Dutch Health Care Inspectorate created an alert on the EU Rapid Alert on Substances of Human Origin platform of one male confirmed case of locally acquired West Nile Virus infection. The case coincides with the discovery of WNV in birds and mosquitos in the Utrecht region in August and September 2020.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential WNV transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of WNV and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of WNV in Europe can be found on the European Centre for Disease Prevention and Control’s website.

Information on updated JPAC guidance can be found on JPAC's website.

Issued 24 August 2020 

Notice for  

•    Designated Individuals in the Human Application sector  
•    Licence contacts in the Organ Donation and Transplantation sector  

Scope 

This alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of West Nile Virus (WNV) in individuals in Spain.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice. 

Issue 

On 21 August 2020, the National Transplant Organization in Spain created an alert on the EU Rapid Alert on Substances of Human Origin platform confirming an outbreak of neuro-invasive West-Nile virus infection in the province of Seville (Andalucía region), Spain. 

Action taken by the HTA 

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential WNV transmission from donors to recipients. 

Actions for establishments 

This alert is to ensure that all establishments are aware of the recent reports of WNV and can review their donor selection and evaluation procedures accordingly. 

Up-to-date information on cases of WNV in Europe can be found on the European Centre for Disease Prevention and Control's website.  

Information on updated JPAC guidance can be found on JPAC's website. 

Issued 3 October 2019

Notice for 

•    Designated Individuals in the Human Application sector 
•    Licence contacts in the Organ Donation and Transplantation sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about a recent case of Dengue in an individual in Spain.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 2 October 2019, the Organización Nacional de Trasplantes (ONT) in Spain created an alert on the EU Rapid Alert on Substances of Human Origin platform confirming a case of Dengue in a person residing in a municipality of Santa Coloma de Gramanet (Barcelona) in the region of Catalonia. This case has been considered as a possible autochthonous case.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential Dengue transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of Dengue and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of Dengue in Europe can be found on the ECDC website.

Issued 20 August 2019 – updated 13 September 2019

Notice for 

•    Designated Individuals in the Human Application sector 
•    Licence contacts in the Organ Donation and Transplantation sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of West Nile Virus (WNV) in individuals in France, Austria and Romania.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 5 August 2019, the Agence Nationale de Securité du Médicament (ANSM) in France created an alert on the EU Rapid Alert on Substances of Human Origin (RATC) platform confirming a case of neuro-invasive West-Nile virus infection in a person residing in Frejus (Var department) in southern France. The patient did not report any recent travel outside the Var department. Therefore, this case is considered autochthonous and most likely acquired in the city of Frejus.

On 20 August 2019, Austrian Agency for Health and Food Safety - Federal Office for Safety in Healthcare created an alert on the same platform advising of the first confirmed WNV case in the region of Lower Austria.

Update: On 13 September 2019, the Ministry of Health – Directorate of Public Health Control (Romania) created an alert on the RATC platform advising of eight confirmed cases of West Nile meningitis / encephalitis during the period 30 July 2019 – 1 September 2019. The confirmed cases are from Bucuresti (1), Constanta (3), Tulcea (2), Olt (1), and Buzau (1).

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential WNV transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of WNV and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on cases of WNV in Europe can be found on the ECDC website.

Issued: 14 August 2018

Notice for:

•    Designated Individuals in the Human Application sector 
•    Licence contacts in the Organ Donation and Transplantation sector 

Scope

This alert is being issued by the Human Tissue Authority (HTA) and includes information about recent cases of West Nile Virus (WNV) in individuals in Romania and France.

Please circulate this information to staff within your establishment undertaking activities which may be affected by this notice.

Issue

On 3 August 2018, the Romanian Directorate of Public Health Control created an alert on the EU Rapid Alert on Substances of Human Origin platform advising that seven individuals in the counties of Braila, Bacau, Bucuresti, Ilfn, Botosani, Dolj and Olt had been diagnosed as infected with WNV.

On 11 August 2018, the Agence Nationale de Securité du Médicament (ANSM) in France created an alert on the same platform advising of 3 autochthonous human cases of WNV (1 confirmed and 2 probable) in the city of Nice in the Alpes-Maritimes department of France.

On 13 August, the European Centre for Disease Prevention and Control (ECDC) issued a rapid risk assessment relating to the early large increase in WNV infections reported in the EU/EEA and EU neighbouring countries.

On 15 August, the Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC) updated the Geographical Disease Risk Index (GDRI) for France and Monaco.

Action taken by the HTA

The HTA has issued this alert to all UK establishments that handle human tissues and cells for human application or are involved in solid organ transplantation to raise awareness of potential WNV transmission from donors to recipients.

Actions for establishments

This alert is to ensure that all establishments are aware of the recent reports of WNV and can review their donor selection and evaluation procedures accordingly.

Up-to-date information on WNV and a copy of the rapid risk assessment produced by the ECDC can be found on their website.  The GDRI information can be found on there's.