Human Tissue Authority

The regulator for human tissue and organs

Inspection guidance - part 2: Site visits

This document is designed to provide you with information about the Human Tissue Authority (HTA) inspection process, so that you and your staff can prepare for an HTA inspection.

There is a first part of this guidance, covering general inspection information
The appendix - applicable to both parts one and two - can be downloaded here
The whole document - parts one and two, plus the appendix - can be downloaded here


Documentation required for a site visit inspection

Prior to the site visit, the DI, LH (or LH representative) and PD(s) should evaluate progress against meeting the HTA standards as well as meeting the statutory, standard and any additional licensing conditions placed on the licence.

The HTA inspector will request specific types of documentation. This should be available for the HTA inspector to review; both paper and electronic copies of the documentation are acceptable (see Annex 2 of this guide for lists of documentation which the HTA will require).

To aid planning of the inspection, the DI will usually be asked to send selected documents to the HTA prior to the site visit inspection.

The HTA inspection team

The HTA inspection team for themed inspections will usually consist of a single inspector, who will be an HTA Regulation Manager. In addition, other individuals may attend inspections as observers, for example HTA Authority Members.

Inspection timetable

The HTA inspector will liaise with the DI and/or LH (or LH representative) to confirm a timetable for the site visit inspection, and this will be sent out in advance of the visit.  During a site visit inspection, we will do our best to ensure that the day-to-day operation of the establishment continues.

The HTA inspector will draft a site visit inspection timetable based on the scope of the inspection, our knowledge of the establishment and its staff and the sector as a whole. (See Annex 1 for an example HTA inspection timetable.)

Inspector requirements

The inspector will require the use of one room for the duration of the inspection. The room will be used by the inspector as a base. The base room should be available for lunch and for review of documents.

It is preferable for the interviews with staff to take place in their normal working environment, or in the base room if this is more suitable.

It would be helpful if you could provide the inspector with lunch, for which costs can be reimbursed on application.

The site visit themed inspection format

Introductory meeting

There will be an introductory meeting with the DI, PD(s) and LH / LH representative. Any staff members involved with the licensed activities are welcome to attend if considered appropriate by the DI.

The aims of the meeting are to:

  • introduce the HTA inspector
  • for the establishment to introduce staff working under the HTA licence
  • summarise the context for the inspection
  • outline the timetable for the inspection
  • provide establishment staff with an opportunity to express any concerns and ask any questions

Visual inspection

The DI (or appropriate member of establishment staff) will be asked to show the inspector the various areas within the premises where the licensed activities take place.

Review of documents

To assist the inspector and to ensure that the review of documents runs smoothly, the documentation should be set out in a logical sequence. In addition, the documentation should either be indexed or a note should be provided to outline the documents provided. This is to ensure that the inspector can readily review and assess the documents to understand current working practices and to verify information.

Where documents are stored electronically the inspector should be set up with a computer for the duration of the inspection and be provided with the appropriate passwords and instruction.

It may be necessary to provide the inspector with patient records; these will form part of the document review as well as the traceability audit.

Traceability audit

Undertaking an audit of the traceability of stored material is a key part of the site visit inspection. Several samples from your register or database will be traced. If the information is available this may be from where the consent is recorded to the stored material and vice versa. However this will vary depending on the activities carried out by the establishment. The purpose of the audit is to check the accuracy of labelling, that correct consent has been obtained and recorded and, where appropriate, that disposal requests have been complied with. 

Interviews

Interviews can involve any staff that the inspector would like to interview. The inspector will always need to interview the DI. Additionally interviews may include the LH / LH representative, some or all PD(s) and a sample of other staff whose work is directly relevant to the activities authorised by the licence. In addition, inspectors will ask questions of staff working under the licence as they meet them during the inspection.

Feedback meeting

At the end of the site visit inspection, the inspector will provide feedback on key issues to the DI, PD(s) and the LH / LH representative. Any staff members involved with the licensed activities are welcome to attend if considered appropriate by the DI.

The inspector will also outline the next steps. Any particular examples of strengths or robust practice which have been observed during the site visit inspection will be outlined. He/she will also feedback on any shortfalls, 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, and also offer advice on improvements. The HTA may also update establishment staff on achievement with the statutory, standard and any additional licensing conditions on the licence.

Inspection Report

The inspection report will summarise the suitability of the establishment to carry out the activities regulated by the HTA, whether the conditions of the licence are met and whether the HTA licensing standards are being met. Where HTA licensing standards are not met, any shortfalls will be identified and the severity of these shortfalls reported. The report will also outline any regulatory action that the HTA considers necessary.

The inspector has responsibility for drafting the inspection report following the site visit inspection. The report will be reviewed by more senior members of HTA Regulation Directorate.  A draft copy will be sent to the DI by email within 28 calendar days to allow for a review of the factual accuracy of the report. Any comments on factual accuracy must be received within the following 14 calendar days. The inspector will consider these comments in finalising the inspection report. However, the inspector’s decision to amend the report will be based upon all the evidence that has been gathered to support the final report.

The inspector will finalise the report and send it to the DI by email. If the inspector has noted shortfalls, a timeline will be set for receipt of a corrective and preventative action plan from the establishment to address the shortfalls.

If more serious regulatory action is warranted by the evidence gained at a site visit inspection, for example if the HTA proposes to vary the licence to place additional licensing conditions, or revoke a licence, then a Notice of Proposal will be appended to the inspection report. The DI or LH/LH representative has 28 days to provide
 
notice of his/her intention to make representations against this proposal. If no notice of intention to make representations is made, a revised licensing annex A with any additional licensing conditions on the licence or a notice of decision will be sent out shortly after this period.

If the HTA believes a licence should be suspended or Directions should be issued to an establishment, these will be issued promptly following the site visit inspection; under these circumstances there is no opportunity to make representations

Evaluation of the inspection

An evaluation form will be given to the establishment at the feedback meeting which will invite feedback from inspected establishment staff about the inspection process. This information is used to report on, and where required, improve the HTA inspection process
 

Audience: