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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 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
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)
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
The inspection process • Phase one inspection • Desk-based • Phase two inspection • Site visit
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
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
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
Site inspection • Date agreed • Inspection team assigned • Lead inspector will contact the DI • Timetable will be agreed • List of required documents provided
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
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
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
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
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
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
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
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
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