Please see below for a number of frequently asked questions from a specific category. Simply select one of the questions of interest, the answer will then appear below. For the complete list of categories please visit the main FAQs page.
Our intention in extending the publication scheme is to be more transparent about the regulatory action we take. This is in the public interest. We want to maintain and enhance the confidence of the public, on whose behalf we regulate. An establishment that is inspected has the benefit of the advice and assessment of the HTA inspection team. Publication of the inspection report allows other stakeholders to have the benefit of this information as well. This will help raise standards and improve performance against the regulatory requirements because stakeholders will be able to use the information in the reports to identify shortfalls with regulatory requirements themselves. (Back to top)
Yes. The HTA and other health regulators are required to comply with the MacRory report (“Regulatory Justice: Making Sanctions Effective” – Professor Richard MacRory). The MacRory report requires that regulators who undertake enforcement actions do so in a transparent way.
The rationale for Macrory’s recommendations is that regulators should be more accountable to those they regulate and to those on whose behalf they are regulating.
Some establishments in our remit need to hold a HTA licence to carry out their work. We assess these establishments against regulatory requirements when they first apply to the HTA for a licence and then we inspect the establishment on a site visit to check the regulatory requirements have been met.
For establishments in the human application sector, the Human Tissue (Quality and Safety for Human Application) Regulations 2007 requires an inspection to be conducted every two years.
As part of the inspection process, the HTA inspection team works with staff in the establishment to help them meet standards. Where there are shortfalls with our standards Designated Individuals (DIs) are asked to work with the HTA to agree how they will address identified shortfalls.
Inspections are scheduled based on risk. Regulation managers use their professional judgement and assess information. We calculate risk each time we are in receipt of information about an establishment in our remit (e.g. after receiving a licence application or after previous inspections). The risk we refer to here is regulatory risk, which is the risk of our standards not being met or legal and regulatory requirements not being adhere to.
Where the HTA determines that a licensing standard is not met, the improvements required are stated and the level of the shortfall is classified as ‘Critical’, ‘Major’ or ‘Minor’.
If we identify a minor or major shortfall then we ask the establishment to identify the measures that need to be taken to address these shortfalls and document this in a corrective and preventative action plan (CAPA). Alternatively, for example where critical shortfalls are identified we may inform an establishment about actions which must be taken immediately. We do this by issuing legal orders called ‘directions’ which usually require an establishment to take action with immediate effect from the date the special directions come into force. We require confirmation that action has been taken by the date we specify and establishments that fail to do so may risk more serious regulatory action such as suspension or revocation of an HTA licence. In other cases of critical shortfalls, we consider what other action may be taken, including adding conditions to the licence or even suspending or revoking the licence.
Directions require the DI and Licence Holder to improve ways of working so that standards are met. It is mandatory for these directions to be followed straightaway.
Inspection reports detail background information about the activities the establishment is carrying out and an indication of any shortfalls in meeting the HTA standards. In addition there are several appendices to the report:
- appendix 1 outlines the HTA inspection process
- appendix 2 outlines the classification of the level of shortfall
- appendix 3 outlines the full set of standards that an establishment has been assessed against
HTA-licensed establishments are required to meet our standards. The standards fall into four broad categories:
- governance and quality systems
- premises, facilities and equipment
The full list of standards is outlined in Appendix 3 of the inspection report.
When major or minor shortfalls have been identified following the inspection site visit, the establishment will be asked to complete a corrective and preventative action (CAPA) plan which outlines the steps that will be taken to address the shortfalls.
Yes. Once the report has been drafted it will be sent to Designated Individuals (DIs) and Licence Holders to check for factual accuracy.
In addition, there will be an opportunity for DIs and Licence Holders to identify information they believe to be commercially sensitive. This will be during the stage of checking the factual accuracy of the inspection report. DIs and Licence Holders will be asked to provide reasons for why they believe the information to be commercially sensitive. The HTA will make a final decision on whether to redact or not based on principles within the FOI Act.