Human Tissue Authority

The regulator for human tissue and organs

Appendix 1: Licensing and inspection processes

Inspections 

We use the term ‘inspection’ to describe when we visit an establishment to meet with staff, view premises and facilities, and review policies and procedures. 

We carry out inspections to assess if the Designated Individual (DI) is suitable to supervise the activity covered by the licence, as it is their responsibility to ensure that: 

  • other staff working under the licence are suitable; 
  • suitable practices are used when carrying out the activity; and 
  • the conditions of the licence are met. 

We also need to be satisfied that the licence applicant or holder, the establishment’s premises, and the practices relating to licensed activities, are suitable. 

To help us reach our decisions, we have developed standards under four headings: Consent; Governance and Quality; Premises, Facilities and Equipment; and Disposal. 

After every site visit inspection, we write a report documenting our findings. Where the HTA determines that a licensing standard is not met, the improvements required will be stated and the level of the shortfall will be classified as ‘Critical’, ‘Major’ or ‘Minor’. Where the HTA is not presented with evidence that an establishment meets the requirements of an expected standard, it works on the premise that a lack of evidence indicates a shortfall. 

The action an establishment will be required to make following the identification of a shortfall is based on the HTA’s assessment of risk of harm and/or a breach of the HT Act or associated Directions. 


Critical shortfall: 

A shortfall which poses a significant risk to human safety and/or dignity or is a breach of the Human Tissue Act 2004 (HT Act) or associated Directions 

or 

A combination of several major shortfalls, none of which is critical on its own, but which together could constitute a critical shortfall and should be explained and reported as such.

A critical shortfall may result in one or more of the following: 

(1) A notice of proposal being issued to revoke the licence 
(2) Some or all of the licensable activity at the establishment ceasing with immediate effect until a corrective action plan is developed, agreed by the HTA and implemented. 
(3) A notice of suspension of licensable activities.
(4) Additional conditions being proposed 
(5) Directions being issued requiring specific action to be taken straightaway 


Major shortfall: 

A non-critical shortfall that: 

  • poses a risk to human safety and/or dignity, or 
  • indicates a failure to carry out satisfactory procedures, or 
  • indicates a breach of the relevant CoPs, the HT Act and other relevant professional and statutory guidelines, or 
  • has the potential to become a critical shortfall unless addressed 

or 

A combination of several minor shortfalls, none of which is major on its own, but which, together, could constitute a major shortfall and should be explained and reported as such.
 
In response to a major shortfall, an establishment is expected to implement corrective and preventive actions within 1-2 months of the issue of the final inspection report. Major shortfalls pose a higher level of risk and therefore a shorter deadline is given, compared to minor shortfalls, to ensure the level of risk is reduced in an appropriate timeframe. 


Minor shortfall: 

A shortfall which cannot be classified as either critical or major, but which indicates a departure from expected standards.
 
This category of shortfall requires the development of a corrective action plan, the results of which will usually be assessed by the HTA either by desk based or site visit. 
In response to a minor shortfall, an establishment is expected to implement corrective and preventive actions within 3-4 months of the issue of the final inspection report. 

 

Follow up actions 

A template corrective and preventive action plan will be sent as a separate Word document with both the draft and final inspection report. The establishment must complete this template and return it to the HTA within 14 days of the issue of the final report. 

Based on the level of the shortfall, the HTA will consider the most suitable type of follow-up of the completion of the corrective and preventive action plan. This may include a combination of 

  • a follow-up site-visit inspection 
  • a request for information that shows completion of actions 
  • monitoring of the action plan completion 
  • follow up at next desk-based or site-visit inspection. 

After an assessment of the establishment’s proposed action plan, they are notified of the follow-up approach the HTA will take.

Reports for site visit inspections which have taken place since 1 November 2010 are published on our website.

 

Last updated on: 3 Aug 2016