| Consent standards | |
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| C1 Consent is obtained in accordance with the requirements of the Human Tissue Act 2004 (HT Act) and as set out in the HTA’s Codes of Practice |
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| a) Consent procedures are documented and these, along with any associated documents, comply with the HT Act and the HTA’s Codes of Practice. |
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| b) Consent forms are available to those using or releasing relevant material for a scheduled purpose. |
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| c) Where applicable, there are agreements with other parties to ensure that consent is obtained in accordance with the requirements of the HT Act and the HTA’s Codes of Practice. |
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| d) Written information is provided to those from whom consent is sought, which reflects the requirements of the HT Act and the HTA’s Codes of Practice. |
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| e) Language translations are available when appropriate. |
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| f) Information is available in formats appropriate to the situation. |
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| C2 Staff involved in seeking consent receive training and support in the essential requirements of taking consent |
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| a) There is suitable training and support of staff involved in seeking consent, which addresses the requirements of the HT Act and the HTA’s Codes of Practice. |
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| b) Records demonstrate up-to-date staff training. |
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| c) Competency is assessed and maintained. |
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| Governance and quality system standards |
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| GQ1 All aspects of the establishments work are governed by documented policies and procedures as part of the overall governance process |
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| a) Ratified, documented and up-to-date policies and procedures are in place, covering all licensable activities |
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| Guidance |
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| At a minimum, it is expected that most establishments will have standard operating procedures (SOPs) covering the following activities: |
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- consent;
- collection;
- receipt;
- labelling;
- specimen preperation / preservation;
- storage;
- relevant transport arrangements;
- cleaning and decontaminsation;
- disposal.
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| A standard operating procedure (SOP) should be a clear and accurate representation of an existing procedure or process, preferably set out in the format of a stepwise guide. SOPs should be understandable to enable new staff to follow a procedure from beginning to end. They should be detailed enough to ensure uniformity between staff in the performance of a specific function and should be followed to the letter by all staff who have been appropriately trained. |
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| People undertaking the processes should be involved in developing the SOPs to ensure that the written procedures reflect actual practices. Regular review of SOPs will help to prevent incremental departure from written processes with passing time and allow establishments to identify improvements. Establishments should introduce a system to record that staff have read and understood SOPs. |
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| If human tissue is to be transferred between establishments, consideration must be given to minimise the likelihood of theft, damage or loss during transport. Some form of formal transfer arrangement, for example, as part of a Material Transfer Agreement (MTA) should define how the human tissue is preserved, any potential contamination risks associated with it; and who is responsible for disposal, if applicable. |
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| b) There is a document control system. |
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| Guidance |
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| Governance documents should include: |
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- revision history and version number;
- 'effective from' date;
- review date (at least every three years);
- pagination;
- author and reviewer names.
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| c) There are change control mechanisms for the implementation of new operational procedures. |
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| d) Matters relating to HTA-licensed activities are discussed at regular governance meetings, involving establishment staff. |
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| e) There is a system for managing complaints. |
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| GQ2 There is a documented system of audit |
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| a) There is a documented schedule of audits covering licensable activities |
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| b) Audit findings include who is responsible for follow-up actions and the timeframes for completing these |
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| GQ3 Staff are appropriately qualified and trained in techniques relevant to their work and are continuously updating their skills |
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| a) Qualifications of staff and all training are recorded, records showing attendance at training. |
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| b) There are documented induction training programmes for new staff. |
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| c) Training provisions include those for visiting staff. |
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| d) Staff have appraisals and personal development plans. |
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| GQ4 There is a systematic and planned approach to the management of records |
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| a) There are suitable systems for the creation, review, amendment, retention and destruction of records. |
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| b) There are provisions for back-up / recovery in the event of loss of records. |
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| c) Systems ensure data protection, confidentiality and public disclosure (whistle-blowing). |
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| GQ5 There are systems to ensure that all adverse events are investigated promptly |
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| a) Staff are instructed in how to use incident reporting systems |
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| b) Effective corrective and preventive actions are taken where necessary and improvements in practice are made. |
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| Relevant examples of adverse events include: |
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- specimen loss;
- missing or incorrect documentation;
- security breach;
- abnormalities in storage temperature readings;
- inappropriate disposal.
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| GQ6 Risk assessments of the establishment’s practices and processes are completed regularly, recorded and monitored |
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| a) There are documented risk assessments for all practices and processes requiring compliance with the HT Act and the HTA’s Codes of Practice. |
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| Risk assessments should include the risks relating to the premises, practices and procedures connected with licensed activities, including: |
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- receiving and/or storing specimens without appropriate consent documentation;
- storing or using human tissue after consent withdrawal;
- storage failure or other damage affecting human tissue quality for useful research;
- loss of human tissue;
- sample mix-up or loss of traceability;
- transport of specimens to and from the establishment;
- security arrangements;
- incorrect disposal.
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| b) Risk assessments are reviewed regularly. |
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| Guidance |
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| Risk assessments should be reviewed periodically (typically, every 1-3 years) and the actions to mitigate risks updated as necessary. |
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| Risk assessments should also be reviewed following an incident. |
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| c) Staff can access risk assessments and are made aware of risks during training. |
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| Traceability |
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| T1 A coding and records system facilitates the traceability of bodies and human tissue, ensuring a robust audit trail |
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| a) There is an identification system which assigns a unique code to each donation and to each of the products associated with it. |
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| b) A register of donated material, and the associated products where relevant, is maintained. |
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| c) An audit trail is maintained, which includes details of: when and where the bodies or tissue were acquired and received; the consent obtained; all sample storage locations; the uses to which any material was put; when and where the material was transferred, and to whom. |
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| d) A system is in place to ensure that traceability of relevant material is maintained during transport. |
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| e) Records of transportation and delivery are kept. |
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| f) Records of any agreements with courier or transport companies are kept. |
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| g) Records of any agreements with recipients of relevant material are kept. |
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| T2 Bodies and human tissue are disposed of in an appropriate manner |
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| a) Disposal is carried out in accordance with the HTA’s Codes of Practice. |
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| b) The date, reason for disposal and the method used are documented. |
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| Premises, facilities and equipment standards |
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| PFE1 The premises are secure and fit for purpose |
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| a) An assessment of the premises has been carried out to ensure that they are appropriate for the purpose. |
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| b) Arrangements are in place to ensure that the premises are secure and confidentiality is maintained. |
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| c) There are documented cleaning and decontamination procedures . |
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| Guidance |
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| Documented cleaning and decontamination procedures should be supported by schedules. |
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| PFE2 There are appropriate facilities for the storage of bodies and human tissue |
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| a) There is sufficient storage capacity. |
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| b) Where relevant, storage arrangements ensure the dignity of the deceased. |
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| c) Storage conditions are monitored, recorded and acted on when required. |
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| Guidance |
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| Documented temperature monitoring allows establishments to easily visualise and identify when temperatures are out-of-range. It can also demonstrate temperature trends, to identify when storage conditions may be deteriorating and to alert staff to developing equipment failure. Temperature alarms should be regulary tested and manually challenged periodically to ensure that they are operating as expected. |
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| Signs should be added to freezers to define alarm set points for the temperature ranges so that staff are visually reminded of minimum and maximum temperatures. |
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| Where storage is critical, an appropriate remote temperature monitoring alarm and callout system may be required. |
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| Checks and filling of liquid nitrogen dewars should be documented. |
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| Where material can be stored at ambient/room temperature, this does not mean that storage conditions do not need to be monitored. |
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| d) There are documented contingency plans in place in case of failure in storage area. |
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| Guidance |
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| The establishment must have contingency arrangements in place should there be an emergency situation that renders the premises unusable for the storage of human tissue; this may need to be through a formalised arrangement with another HTA-licensed establishment for transfer of material. |
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| General guidance |
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| Areas used for storage of human tissue for use in research must provide an environment that is safe for those working under the licence and preserves the integrity of the tissue. |
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| Refrigerators, freezers and other vessels which contain human tissue should be appropriately labelled so that staff are aware of the necessity to maintain the quality, safety and security of such material and prevent mix-ups with other tissues. |
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| PFE3 Equipment is appropriate for use, maintained, validated and where appropriate monitored |
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| a) Equipment is subject to recommended calibration, validation, maintenance, monitoring, and records are kept. |
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| b) Users have access to instructions for equipment and are aware of how to report an equipment problem. |
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