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HTA inspection process

HTA inspection process. 25 March 2009 Kate Rolfvondenbaumen. Aims of the presentation. Provide you with information about the inspection process Help you and your staff be better prepared for a site visit inspection. Total number of licensed human application establishments.

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HTA inspection process

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  1. HTA inspection process 25 March 2009 Kate Rolfvondenbaumen

  2. Aims of the presentation • Provide you with information about the inspection process • Help you and your staff be better prepared for a site visit inspection

  3. Total number of licensed human application establishments

  4. Statutory requirements • Legal obligation: • to satisfy ourselves that both the DI and the LH are suitable • establishment has appropriate premises, facilities and equipment • all procedures are carried out to required standards • governance and quality systems are in place to ensure safety to tissues and cells (and patients)

  5. Risk-based approach • Use a risk matrix to facilitate scheduling of phase two inspections • Must visit all establishments in the Human Application sector every two years • Documents used are The Human Tissue (Quality and Safety) for Human Applications Regulations 2007, compliance report, annual activity report, Human Tissue Act 2004, codes of practice and our Directions • Also consider DI response time, DI training and whistleblowers

  6. The inspection process • Phase one inspection • Desk-based • Phase two inspection • Site visit

  7. Phase one - desk based • Involves a review of the compliance form completed at the time of application • Reviewed by two separate members of the Regulation Directorate • Initial review will often involve multiple phone calls and/or emails with the DI to gather more information • He/she will make the initial recommendations of conditions or may provide advice and guidance if appropriate

  8. Second level of assessment • Further additional review of the report and the recommendations of the initial assessor • Can involve further clarification with the DI if needed • Licensing decision will be made and establishment notified • Details of the assessment are fed into the risk-matrix

  9. Phase two - site visit • To ensure that information included in the compliance report is an accurate reflection of the current situation • To follow up with any conditions that may have been placed on the licence

  10. Site inspection • Date agreed • Inspection team assigned • Lead inspector will contact the DI • Timetable will be agreed • List of required documents provided

  11. The inspection team • One or two members of the Regulation Directorate based on appropriate skills and understanding of the procedures • Occasionally there may be observers

  12. Timetable

  13. Key elements of a site visit • Introductory meeting • Includes DI, PDs, LH or CLHC, members of staff working under the licence • Aims of the meeting: • introduce the inspection team • explain the structure and statutory remit of the HTA • summarise the context of the inspection • outline the timetable for the day • opportunity for questions

  14. Visual inspection • Expect to visit all areas where licensed activities take place • This includes clean rooms, labs, storage areas • During the tour the inspectors may take the opportunity to speak informally to staff to gather information

  15. Documentation review • List of required documents will be provided prior to the inspection • Documents should be indexed and laid out in a logical sequence • Looking for evidence of document and version control as part of the quality system • Subsequent inspections we will be looking for changes to procedures, recent validations

  16. Audit trail • Key part of the inspection process • Several samples will be randomly selected and traced • Purpose is to: • ensure traceability from donor to recipient is in place • check the validity of the labelling • determine the correct consent has been obtained • where appropriate confirm the disposal requests have been complied with

  17. Interviews • Lead inspector will select individuals to interview based on the current information • Always include the DI • Other potential candidates include individuals listed as PDs on the licence, individuals working under the licence, the licence holder or the contact person

  18. Feedback meeting • Opportunity to feed back to the DI and others on key findings • Identification of probable conditions (if applicable) • Update on progress to meeting existing conditions • Offer advice and guidance • Highlight any areas of good practice we have identified

  19. Inspection report • Lead inspector will draft the report and send it within 28 calendar days • Comments for factual accuracy must be submitted within 14 calendar days • Includes any conditions which have been proposed or removed • Includes advice and guidance

  20. Feedback • Evaluation form sent to the establishment a few days after the inspection • All individuals who participated in the inspection can submit one • We value this feedback and use it to improve our quality of service

  21. Questions?

  22. www.hta.gov.uk

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