General information on inspections
At a minimum, the following individuals should read this guidance:
- the Designated Individual (DI);
- the Licence Holder / Licence Holder (LH) representative;
- the Person(s) Designated on a licence (PD);
- all interviewees at a site visit inspection.
Human Tissue Act 2004 (HT Act)
The HT Act applies to England, Wales and Northern Ireland. Scotland has its own law called the Human Tissue (Scotland) Act 2006, but the HTA was asked by the Scottish Government to approve transplants from living donors and license organisations that procure, store, test, process, distribute, import and/or export human tissues and/or cells that are intended to treat patients, on its behalf.
Consent is the most important principle of the HT Act. Consent must be given for bodies, body parts, organs and tissues to be stored and used for specific purposes. The HT Act and the work of the HTA have introduced major changes which have had a positive impact on professionals, patients and families.
Together they have given the public confidence that their wishes will be respected and professionals the confidence that they are working within a clear framework and regulated by an organisation that understands their work. The HTA does not regulate the diagnosis or treatment of illnesses in living people, as this is not covered by the HT Act.
Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations)
Under the Q&S Regulations, the HTA is responsible for licensing organisations that: procure, store, test, process, distribute, import and/or export human tissues and/or cells that are intended to treat patients. Examples include: collecting umbilical cord blood in maternity units, storing corneas in eye banks, and processing cartilage for repairing knee injuries.
HTA Directions 001/2021 consolidate and clarify the standards required under the Q&S Regulations. Establishments are required to meet the standards which are detailed in the Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment as implemented by HTA Directions 001/2021.
As part of the regulatory framework, the HTA licenses establishments and carries out inspections to assess whether sector specific standards are met. The HTA’s
authority to carry out site visit inspections is defined in Schedule 5 of the HT Act and Part 5 of the Q&S Regulations.
The HTA regulates establishments in the following sectors:
- Human Application (tissues and cells intended for patient treatment) sector – under the Q&S Regulations
- Post Mortem sector – under the HT Act
- Research sector – under the HT Act
- Anatomy sector – under the HT Act
- Public Display sector – under the HT Act
The HTA has a legal obligation to satisfy itself that:
a) the Designated Individual (DI) is a suitable person to supervise the activity authorised by the licence and that he/she undertakes the following duties, ensuring that:
- other persons to whom the licence applies are suitable persons to participate in the carrying on of the licensed activity;
- suitable practices are used in the course of carrying on the activity;
- the conditions of the licence are complied with.
DIs responsible for licences granted under the Q&S Regulations have the following additional duties:
- secure that the conditions of third party agreements, in relation to the licensed activities authorised to be carried out under their supervision are complied with and;
- secure that the information and confidentiality requirements of Section 13(1) of the Q&S Regulations, are complied with.
b) the Licence Applicant or Licence Holder is a suitable person to be a holder of the licence
c) any premises are suitable for the activity carried on under the authority of a licence
To fulfil its statutory responsibilities, the HTA must be able to assess whether an establishment is suitable to carry out one or more of the activities regulated by the HTA. Suitability is assessed through a process of inspection.
To enable the HTA to make effective judgements, we developed standards with input from professionals working in the sectors we license. These licensing standards form the basis of the licence application and our inspection process. These standards are mandatory for all establishments we license and cover four broad themes:
- governance and quality systems
- premises, facilities and equipment
Meeting the HTA standards is assessed using a four-point scale: standard not met, standard partially met, standard almost met and standard fully met.
Where a shortfall in meeting the standards is identified during a site visit inspection, a shortfall will be noted and assessed as either a critical, major or minor shortfall.
The inspection process
The HTA defines inspection as a process encompassing desk-based assessment, on-site assessment and analysis of information to assess whether the conditions of a licence and HTA licensing standards are met.
Site visit inspections
Site visit inspections are conducted based on the findings from a desk based assessment and any other relevant information. The focus during a site visit inspection is on reviewing operational policies and procedures, inspection of premises, scrutiny of practices which involves review of documentation, and in some cases interviews with a range of staff at the establishment. This allows the HTA to identify any shortfalls in relation to the standards and the conditions of a licence, assess whether the HTA is satisfied with the suitability (as defined in paragraph 11) of an establishment to carry out one or more of the activities regulated by the HTA, offer advice on areas for improvements and identify any particular examples of strengths or robust practice.
Establishments that have received a number of previous HTA inspections may be selected to receive a themed inspection, in order to reduce the burden of regulation on those establishments. Themed inspections will be carried out when the HTA believes that the nature of the licensed activity is lower in risk compared with other establishments involved with human tissues and cells inpatient treatment. Themed inspections will focus on specific HTA Standards which the HTA has identified as common shortfalls across the human application sector in 2013, and will include the following themes:
- Quality Management
- Quality Management System
- Policies and procedures
- Internal audits
- Risk Management
- Risk assessments
- Serious adverse events and reactions
- Donor selection
- Equipment monitoring and maintenance
- Packaging, labelling and distribution agreements
- Storage for end use
- Equipment monitoring and maintenance
There is flexibility within the themes and the HTA may decide to include additional standards within the focus of the inspection. These standards may reflect shortfalls or conditions which have been added to the licence previously, or SAEARs / complaints / information gained from other regulators that have arisen since the last inspection. The HTA will notify the DI of these in advance of the inspection.
Themed inspections provide an opportunity for establishments to demonstrate compliance with the HTA Standards in specific areas, and to follow up on other issues that have arisen since the previous inspection. Focusing on these themes will require less time to prepare documents for the inspection; the focus on a narrower set of HTA Standards than usual will allow the HTA to provide more advice and guidance in these respective areas.
Where an inspection identifies that a standard is not being met or the establishment is not meeting the conditions of a licence, advice may be offered or regulatory action may be taken
Where the HTA is not presented with evidence that the standards or conditions of a licence have been met, a lack of evidence indicates they are not being met.
Shortfalls in meeting the HTA standards
HTA standards are defined for each sector we regulate and are used by the HTA to assess the suitability of an establishment to carry on the licensed activity. It is mandatory for establishments in each sector to meet the standards. Where a standard is not met, the HTA will identify the shortfall and report the level of the shortfall to the establishment as a critical, major or minor. The establishment will be required to produce a corrective and preventative action plan that details how it will address the shortfall identified. The HTA will define timelines for the completion of the action plan and the corrective and preventative actions. The action plan should be submitted to the HTA within 14 days of receipt of the final site visit inspection report unless the HTA has given a shorter timeline because of the seriousness of the shortfall identified. The timelines for completion of the actions in the plan are not fixed but as a guideline;
- critical shortfalls require immediate action;
- major shortfalls require actions to be completed within 1- 2 months; and
- minor shortfalls require actions to be completed within 3 – 4 months.
The HTA will assess progress towards addressing any shortfalls identified. If the HTA cannot confirm that appropriate corrective or protective action has been taken to address a shortfall, the HTA may decide to take further regulatory action.
If a critical shortfall is identified, there are several different types of regulatory action that may be considered. These include variation of licences through, for example, the imposition of additional conditions; the issue of Directions; suspension of a licence or revocation of a licence. The action that the HTA will require an establishment to take following the identification of shortfalls is based on an assessment of risks to patient safety and/or tissue integrity and/or public confidence and/or whether there has been a breach of the HT Act, codes of practice, Q&S Regulations or HTA Directions.
Licences are granted with a number of statutory and standard conditions. These conditions must be met by all licensed establishments.
Where an inspection (either desk-based or site visit) identifies a shortfall, and it is of a serious nature (for example where protection of the public cannot be maintained) additional licensing conditions may be proposed for an establishment’s licence to regulate the activities carried out under the licence.
A risk-based approach to site visit inspections
The HTA uses a risk-based regulatory approach to prioritise site visit inspections. In this context, the risk the HTA refers to is regulatory risk, i.e. the risk of not meeting the requirements of the legislation that the HTA was set up to implement. The primary documents that inform the framework for regulatory risk are: the HT Act and the associated Regulations, including for the human application sector, the Q&S Regulations. The legislation is supported by other documents that are developed by the HTA. Where possible, we develop this additional guidance with input from those we regulate. These documents include Codes of Practice, Directions, and licensing standards.
The HTA has a statutory responsibility to undertake an inspection of all establishments involved in activities for human application (tissues and cells intended for patient treatment) every 2 years.
The HTA targets site visit inspections at those establishments deemed to be at highest risk both across sectors and within sectors. We also conduct site visit inspections of low-risk establishments. We do this to assess the validity of the risk assessment methods we use when scheduling inspections, which in turn helps to ensure that the assessment of risk is appropriate. The inspections also allow the HTA to gather knowledge from high performing organisations and to share learning across our stakeholders.