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Guide to Completion of the Post Mortem Licence Application The following activities can only take place under the authority of a licence from the Human Tissue Authority:

The making of a post-mortem examination

The storage of the body of a deceased person or relevant material1 which has come from a human body for use for a Scheduled Purpose2

The removal from the body of a deceased person (otherwise than in the course of an anatomical examination or a post-mortem examination) of relevant material of which the body consists or which it contains, for use for a Scheduled Purpose

This document outlines the legal framework of the licensing system, explains the application process and provides guidance on how to complete the application form. Our Code of Practice 3 provides additional guidance on the licensing requirements for the Post Mortem sector.

General 1. The Human Tissue Authority (HTA) was established under the Human Tissue Act (HT Act). The HTA

licenses a number of activities and undertakes inspections of establishments carrying out these activities to ensure the requirements of the HT Act are being met.

2. We operate a continuous licensing system, with an annual licensing fee, although in some

circumstances we can issue fixed-term licences. 3. The HTA must receive an application before it can grant a licence. The application must specify the

premises at which the licensable activities will take place. Where the establishment has multiple sites, such as a main site with remote satellite sites where bodies, body parts or tissue samples are stored, we can accept a single application, provided:

The same Designated Individual (DI) is appointed for all sites; and

All sites work to the same procedures and governance arrangements.

1 Go to http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm for more information on relevant

material 2 See Schedule 1 of the HT Act (Scheduled Purposes) Part 1 and Part 2

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4. Satellite sites are premises under the same governance arrangements as the main site (the hub), which are supervised by the same DI. We issue separate licences for the hub and for each satellite site, under the same licensing number. Satellite sites are eligible for a reduced licence fee.

Completing and submitting a licence application 5. Licence applications must be downloaded from the HTA website and submitted by email to

licensing.enquiries@hta.gov.uk. 6. The application form has three sections:

Information about the establishment

Information about the DI and the Licence Holder

Information about how the HTA licensing standards are met 7. The licensing standards section contains four sets of standards that applicants must assess and

evaluate their performance against. These are:

Consent

Governance and Quality Systems

Premises, Facilities and Equipment

Disposal 8. The application form will be evaluated using the evidence on the application form. The evaluation

will enable us to make an informed and proportionate licensing decision.

9. Examples of evidence have been provided beneath each standard to help you provide examples of how you meet the HTA standards. You should include details of what procedures you have in place to meet each standard, or if the standard is not being fully met, what you are doing in order to achieve the standard. Key strengths or areas identified for improvement can also be given.

10. We do not require documented evidence to be supplied with the application; for example you may

list relevant standard operating procedures, but we do not need you to send these documents with the application.

11. The establishment should assess its performance against the standards using a scale of 1–4, based

on the evidence submitted for each standard. The scores are not cumulative and each standard is evaluated individually. The ratings are:

N/A Not applicable

1 Standard not met

2 Standard partially met

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3 Standard almost met

4 Standard fully met or exceeded

12. Where a standard is not applicable please select ‘N/A’ and provide an explanation of why the

standard is not applicable to your establishment. 13. We may contact applicants and undertake a site visit to obtain any additional information or

evidence required. This could be at any stage in the application process. 14. Where applications are deemed to be complete, we will aim to issue a licence offer within 20

working days of receipt of the application.

15. Any incorrect or misleading information provided in an application could lead to the revocation of any licence granted.

Granting a licence 16. A licence will be granted when we receive written acknowledgement of the licence offer from the

proposed DI and the Licence Holder.

17. If a licence application is refused or granted with conditions and the applicant chooses to challenge this decision, the proposed Licence Holder and/or the proposed DI must give notice of their intention to make representations within 28 days from the date that notice of the proposed licensing decision was given by the HTA (i.e. the date on the Licence Offer/Notice of Proposal letter). This is a strict time limit laid down by statute.

18. Notification of the intention to make representations may be given to the HTA either orally or in writing by the person entitled to make representations. If the request is given orally, it must be made to the Authority’s Director of Regulation, one of the Regulation Managers or one of the Heads of Regulation only. The person receiving the oral request to make representations will record the request and confirm this in writing to the person proposing to make representations.

19. The person entitled to make representations must after any oral request then confirm their intention to make representations in writing to the HTA. This may be by letter, email and/or fax to the Director of Regulation.

20. The following section gives specific help on completing the Application Form. Please contact us by

emailing licensing.enquiries@hta.gov.uk if you need further information about any part of the application form or our process for considering licence applications.

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How to complete the application form Establishment Information 21. Establishment name

Careful consideration should be given to where the licensed activities are going to take place and whether they extend to more than one area within the premises. Include the department name if applicable. 22. Establishment address A licence application must specify the premises where the activities are to take place. This should be the address of the main site. Where the licensed activity will take place at more than one premises, such as a main site with satellite sites. In this case a separate satellite licence would be needed for each site, however a single application for multiple licences may be made. 23. Names of person(s) who have consented to be designated on the licence (where the establishment

is applying for a licence(s) on single premises) The HT Act allows the DI to designate persons on the licence, with their agreement. Persons Designated can support a DI in overseeing licensable activities.

Satellite Sites 24. Address of satellite site premises and activities to be licensed

Satellite sites are premises under the same governance arrangements as the main site (hub) and are supervised by the same DI. Each satellite site will have its own licence. 25. Names of person(s) who have consented to be designated on the licence at the satellite premises There must be a primary Person Designated at each satellite site who can direct licensable activities at the site and is accountable to the DI. Please provide the name of the primary Person(s) Designated on the licence for the satellite premises and any additional persons to be designated on the licence of the satellite premises.

Application to be Designated Individual (DI) 26. Information about the role of the DI is available on our website.

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27. With regard to the organisational structure of the establishment, please indicate the lines of responsibility between the DI and any persons working under the licence

We must be satisfied the DI is able and willing to supervise the licensed activities. The relationship between the DI and those working under the licence should be described here, as well as the DI’s position in the overall governance structure. 28. Please explain how the DI ensures that staff, who will be working under the licence, are

appropriately qualified and trained in techniques relevant to their work and continuously update their skills

The DI must ensure that suitable practices are carried out by those undertaking the licensed activities; staff training is an important part of this. The DI’s role in ensuring that staff working under a licence are suitably qualified and trained should be described here. 29. Declaration

The DI must read and acknowledge each statement in this section.

Application to be Licence Holder/Corporate Licence Holder 30. The applicant can be a person or a corporate body and must be suitable to hold the position of

Licence Holder. If the applicant is a corporate body, the application to be a Corporate Licence Holder must be completed with a suitable person identified as Licence Holder contact.

31. Declaration The Licence Holder or Corporate Licence Holder contact must read and acknowledge each statement in this section.

Licensing Standards 32. The licensing standards are separated into four main themes: consent; governance and quality

systems; premises, facilities and equipment and disposal. Each of these four sections must be completed.

33. It is important for establishments to demonstrate how they meet HTA quality standards. For each

standard below, we have given examples of how this can be achieved.

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Consent standards

C1 Consent is obtained in accordance with the requirements of the Human Tissue Act 2004 (HT Act) and as set out in the code of practice

There is a documented policy which governs consent for post-mortem examination and the retention of tissue and reflects the requirements of the HT Act and the latest version of the HTA Code of Practice on consent.

There is a documented SOP detailing the consent process (including who is able to take consent, what training they must receive, and what information must be provided to those giving consent for post-mortem examination).

There is written information about the consent process (provided to those giving consent), which reflects the requirements of the HT Act and the latest version of the HTA Code of Practice on consent.

C2 Information about the consent process is provided and in a variety of formats

Relatives are given an opportunity to ask questions.

Relatives are given an opportunity to change their minds and is it made clear who should be contacted in this event.

Information contains clear guidance on options for how tissue may be handled after the post-mortem examination (repatriated with the body, returned to the family for burial/cremation, disposed of or stored for future use).

Where consent is sought for tissue to be retained for future use, information is provided about the potential uses in order to ensure that informed consent is obtained.

Information on the consent process is available in different languages and formats, or there is access to interpreters/translators.

C3 Staff involved in seeking consent receive training and support in the implications and essential requirements of taking consent

There is a training programme for taking consent for post-mortem examination and tissue retention which addresses the requirements of the HT Act and HTA code of practice on consent.

Refresher training is available (e.g. annually).

Attendance at consent training is documented.

If untrained staff are involved in consent taking, they are always accompanied by a trained individual.

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Governance and quality systems standards

GQ1 All aspects of the establishments work are supported by ratified documented policies and procedures as part of the overall governance process

Documented policies and SOPs cover all mortuary/laboratory procedures relevant to the licensed activity. These may include:

o post-mortem examination, including the responsibilities of the APTs and Pathologists (e.g. evisceration) and management of high risk cases

o record keeping o receipt and release of bodies, which reflect out of hours arrangements o lone working in the mortuary o transfer of bodies and tissue (including blocks and slides) to other establishments or off

site o ensuring that tissue is handled in line with documented wishes of the relatives o disposal of tissue (including blocks and slides)

(Note that individual SOPs for each activity are not required. Some SOPs will cover more than one activity.)

Policies and procedures are regularly reviewed (for example, every 1-3 years).

There is a system for recording that staff have read and understood the latest versions of these documents.

Deviations from documented SOPs are recorded and monitored.

GQ2 There is a documented system of quality management and audit

There is a quality manual which includes mortuary activities.

Policies and SOPs are version controlled (and only the latest versions available for use).

There is a schedule for audits to be carried out (which may include vertical and/or horizontal audits).

Audits include compliance with documented procedures, records (for completeness) and traceability.

Audit findings document who is responsible for follow up actions and the timeframe for completing those actions.

Regular audits of tissue being stored at the establishment ensure that staff are fully aware what material is held and why.

There is a complaints system in place.

GQ3 Staff are appropriately qualified and trained in techniques relevant to their work and are continuously updating their skills

Staff are appropriately trained/qualified or supervised.

Staff have annual appraisals.

Staff are given opportunities to attend training courses, either internally or externally.

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Attendance by staff at training events is recorded.

There is a documented training programme for new mortuary staff (e.g. competency checklist).

GQ4 There is a systematic and planned approach to the management of records

There is a system for managing records which includes which records must be maintained, how they are backed up, where records are kept, how long each type of record is retained and who has access to each type of record.

There are documented SOPs for record management.

GQ5 There are documented procedures for donor selection and exclusion, including donor criteria.

This standard is not relevant to the post mortem sector, so you do not need to provide a response to it.

GQ6 A coding and records system facilitates traceability of bodies, body parts, tissues and cells, ensuring a robust audit trail

Organs and tissue samples taken during PM examination are fully traceable.

Details of organs retained and the number of wax blocks and tissue slides made are recorded.

The traceability system includes the movement of tissue samples between establishments.

Details are recorded of tissue that is repatriated or released with the body for burial or cremation.

Regular audits of tissue storage and traceability are undertaken to ensure compliance with operational procedures; tissue samples found which are not being stored with consent are disposed of with reference to the family’s wishes.

GQ7 There are systems to ensure that all adverse events, reactions and / or incidents are investigated promptly

Staff are trained in how to use the incident reporting system.

Staff know how to identify incidents and near-misses which must be reported, including those that must be reported to the HTA

The incident reporting system clearly outline responsibilities for reporting, investigating and follow up for incidents.

The incident reporting system ensures that follow up actions are identified (i.e. corrective and preventative actions) and completed.

Information about incidents is shared with all staff (including the reporter) to avoid repeat errors.

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GQ8 Risk assessments of the establishment’s practices and processes are completed regularly and are recorded and monitored appropriately

All procedures related to the licensed activities (as outlined in standard GQ1) are risk assessed.

Risk assessments include risks associated with non-compliance with HTA standards as well as health and safety risks.

Risk assessments are reviewed regularly (along with SOPs), for example every 1-3 years.

Risk assessments include how to mitigate the identified risks; this includes actions that need to be taken, who is responsible for each action, deadlines for completing actions and confirmation that actions have been completed.

Premises, facilities and equipment standards

PFE1 The premises are fit for purpose

There is sufficient space for the activities to be carried out.

Refrigerated storage units are in good working condition and well maintained.

Surfaces are made of non-porous materials.

The premises are in reasonable condition (structure and cleanliness of floors, walls, entranceways).

The premises are secure (e.g. there is controlled access to bodies, tissue, equipment and records).

PFE2 Environmental controls are in place to avoid potential contamination

There is clear separation of clean, transitional and dirty zones (e.g. doors, floor markings, signs).

There is appropriate PPE available and routinely worn by staff.

There is adequate critical equipment and/or PPE available for high risk post mortems.

There are documented cleaning and decontamination procedures.

There are documented cleaning schedule and records of cleaning and decontamination.

PFE3 There are appropriate facilities for the storage of bodies, body parts, tissues and cells, consumables and records.

There is sufficient capacity for storage of bodies, organs and tissues.

Temperatures of fridges and freezers are monitored on a regular basis.

There are documented contingency plans in place should there be a power failure, or overflow.

Bodies are shrouded whilst in storage.

There is separate storage for infants and babies. If not, special measures are taken for the bodies of infants and babies.

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PFE 4 Systems are in place to protect the quality and integrity of bodies, body parts, tissues and cells during transport and delivery to a destination

There are documented procedures for transportation of bodies and tissue anywhere outside the mortuary (e.g. lab, other establishment), including record-keeping requirements.

There are written agreements in place with any external parties (e.g. undertaker, or courier) who transport bodies and/or tissue behalf of the establishment (laboratory or mortuary).

(Note that coroners usually have their own agreements with external parties for transportation bodies and tissue; however, documentation for traceability purposes must still be maintained by the establishment for these cases.)

PFE5 Equipment is appropriate for use, maintained, quality assured, validated and where appropriate monitored

Items of equipment in the mortuary are in a good condition and appropriate for use: o fridges / Freezers o hydraulic trolleys o post mortem tables o hoists o saws (manual and/or oscillating) o PPE for high risk cases (e.g. respirators)

The use of porous materials is kept to a minimum and has been risk assessed

Maintenance/service records are kept for equipment, including fridges/freezers, trolleys, post mortem tables (if downdraught) and post mortem suite ventilation. (Note that these records may be held by the mortuary or centrally by the Trust, e.g. Estates Department.)

Disposal standards

D1 There is a clear and sensitive policy for disposing of human organs and tissue

There is a documented Trust or mortuary/laboratory policy for the disposal of human tissue, which reflects the requirements of the HTA code of practice on disposal.

The policy states the position with regard to the retention and use of microscope slides, and in particular that tissue slides must be disposed of or returned to the family in accordance with their wishes if consent is not obtained for their continued storage and future use once the PM has concluded.

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D2 Post Mortem tissue is disposed of if consent is not given for its storage and use for scheduled purposes

There are documented procedures for disposal of human tissue, which include methods of disposal for whole organs, wet tissue, wax blocks and microscope slides.

Tissue is disposed of in accordance with the documented wishes of the deceased person’s family.

Disposal details of organs and tissue blocks are recorded, including the date and method of disposal.

There is a rolling programme of tissue disposal that ensures that tissue, including microscope slides, is disposed of in a timely fashion when it is no longer needed for the purposes of the post mortem examination.

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Glossary

Anatomical examination

Examination by dissection for the purpose of teaching, studying or conducting research into the structure of the human body.

Code of practice The HTA codes of practice provide guidance and lay down expected standards for each of the sectors we regulate. There are nine codes available via the HTA website.

Designated Individual (DI)

The individual designated on the licence to supervise the licensable activities being carried out. DIs are trained by the HTA to carry out this important role and they have statutory responsibilities they must fulfil. Further guidance is provided on the HTA website.

Existing holdings The body of a deceased person, or any relevant material which has come from the human body, held immediately prior to 1 September 2006.

Licensed premises

Where the licensed activity takes place. If the licensed activity will take place at more than one place, a separate licence will be issued for each place. Premises in different streets or with different postal codes are considered as being in different places. In contrast, different buildings on a hospital site could be regarded as the same place.

Licence Holder (LH)

The person who holds a licence and is responsible for the payment of any fees charged by the HTA. The LH can be a corporate body. Where the applicant is not the proposed DI, the HTA must be satisfied that the applicant is a suitable person to be the holder of the licence.

Person designated (PD)

A person, or persons, nominated by the DI (in writing to the HTA) who has the ability to 'direct' others in relation to the conduct of activities licensed under the Human Tissue Act 2004. There must be a Person Designated at each satellite site who can direct activities that are licensed there and who is accountable to the DI at the main hub site.

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Post-mortem examination (PME)

Dissection and examination of a body after death, principally in order to determine the cause of death or the presence of disease processes. A hospital post-mortem examination is carried out with appropriate consent to gain a fuller understanding of the deceased person's illness or the cause of death, and to enhance future medical care. Coroners' post-mortem examinations are carried out under the authority of the coroner and without consent to assist coroners in carrying out their functions.

Relevant material Defined by the HT Act as material other than gametes, which consists of, or includes, human cells. In the HT Act, references to relevant material from a human body do not include: (a) embryos outside the human body, or (b) hair and nail from the body of a living person. See policy guidance on how to apply this definition on the HTA website.

Serious Untoward Incident (SUI)

An incident that occurs in post mortem sector establishments which are categorised by the HTA and must be reported accordingly. Further information is available on the HTA website.

Service Level Agreement (SLA)

A formal agreement between two parties to provide a service

Standard operating procedure (SOP)

A document which provides detailed, written instructions to achieve uniformity of the performance of a specific operation, function or task. An SOP must be written with sufficient detail so that someone with limited experience or knowledge of the procedure can successfully reproduce it without supervision.

Tissue Any and all constituent part/s of the human body formed by cells.