UNIVERSITY OF LEICESTER STANDARD OPERATING PROCEDURES. University of Leicester (UoL) Research Governance Office HTA-1006-UoL

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1 UNIVERSITY OF LEICESTER STANDARD OPERATING PROCEDURES University of Leicester (UoL) Research Governance Office HTA-1006-UoL Audit of Research Licenced Human Tissue Authority Facilities Within University of Leicester (UoL) OFFICE BASE Research Governance Office University of Leicester Academic Department Leicester General Hospital Gwendolen Road Leicester LE5 4PW Version 1 - Effective Date: June 2016 SOP HTA-1006-UoL Version 1 June 2016 Page 1 of 10 Next Review: June 2018

2 Standard Operating Procedure: HTA-1006-UoL Audit of Research Licenced Human Tissue Authority Facilities Within University of Leicester (UoL) Research Governance Office June Background This document has been produced in accordance with The Human Tissue Act (2004). It should be read in conjunction with the University s Policy on compliance with the Human Tissue Act in Research, HTA Standards and the Human Tissue Authority s (HTA) Codes of Practice. The Human Tissue Act must be followed by all researchers working under the University s Research Licence and those transferring HTA relevant material as part of an ethically approved research project. 2 Purpose The purpose of this Standard Operating Procedure is to set out the procedure for conducting an internal audit. The main aim of the internal audit is to ensure that all licensed activities related to human tissue, including consent, transportation, storage and disposal are conducted in accordance with the Human Tissue Act (2004) and that internal systems for compliance are effectively in place. To comply with the HT Act it is necessary to ensure that there is a clear and robust audit trail from the collection of human material, through processing, storage, use and distribution, to final use/disposal. All human material acquired by University of Leicester staff and students and any external individuals for storage under a HTA licence must be recorded and its use, distribution and disposal accounted for. These audits therefore aim to support researchers to identify any gaps in compliance and enable solutions to be implemented to meet regulatory standards. 3 Audit Schedule Internal audits are typically conducted by the HTA Governance Officer (HGO) or suitably trained delegated member of staff from Research Governance Office and/or Designated Individual (DI); however a suitably trained individual may be asked to escort the HGO and help conduct these audits under certain circumstances. An internal HTA audit will be conducted at least once a year and for all tissue collections stored under the licence, unless otherwise agreed with the Designated Individual. The audit duration will vary dependent on the size and complexity of the group. The HTA Governance Officer maintains a list of all the research departments operating under the University s Research HTA Licence. At the beginning of each calendar year, the HTA Governance Officer works together with the Persons Designated (PD) (or departmental HTA contact) to agree a suitable date and time to SOP HTA-1006-UoL Version 1 June 2016 Page 2 of 10 Next Review: June 2018

3 conduct the internal HTA audit that year. Once dates have been agreed, an audit schedule for that year is drawn up and presented to the Designated Individual for review. Dates for audits are subject to change, and may be updated throughout the year based on any staff changes, resource or change in processes. Any changes to the audit schedule will be agreed with the DI and the audit schedule updated. Audits can be conducted on a risk assessment basis and triggered where a failure has been reported. These audits can be either be targeted at certain aspects of the licencing requirements, or may be a more general audit to ensure that the group is working within the regulations. The format of these internal audits is set out below. Audit Schedule Preparation Audit Audit report Corrective Actions/ Preventative actions Audit closure The objectives of an internal audit are to: 4 Audit Plan Determine whether or not the tissue is covered by the licence and ensure patient consent is in place; Ensure the premises and equipment used for the storage of human tissue is compliant with HTA guidance and requirements; Ensure that essential documentation relating to all aspects of the human tissue are held by the department/unit; Ensure that SOPs are being followed during the handling/processing of tissue; Ensure that an audit trail is in place from receipt of sample to disposal; Ensure that the health and safety of staff are protected; Identify any problems and suggest solutions; Ensure that those involved are fully trained and experienced and that staff have received the appropriate level of training. In advance of the audit, the HTA Governance Officer will send the auditees e.g. PD, departmental contact, departmental manager and local researchers (not exclusive to these roles) an audit agenda, detailing the proposed structure for the audit. The audit agenda will vary depending on the reason for the audit, the size/scale of the group, type of collection and any perceived risk. There will be opportunity for the auditee to suggest anything that they would like to be included on the agenda. Auditees will also be provided with: A copy of the link to the HTA standards A copy of any previous internal or external audit reports and agreed corrective/preventative actions A copy of the HTA check-list and previous report (where appropriate) Appendix 1. A list of documents/information required in advance of the audit SOP HTA-1006-UoL Version 1 June 2016 Page 3 of 10 Next Review: June 2018

4 In addition, information that may be requested from auditees in advance of the audit includes: Details on sample numbers and types A list of collections stored, including any REC numbers A staff list and training status Study protocol and ethics documentation Consent forms/patient information leaflets Copies of any MTAs or supply agreements. The information required will be communicated with the auditees in advance of the audit to allow them time to prepare. It is the responsibility of the auditees to book a room that is suitable to conduct the audit in, which is free from distractions, and has space to examine documents. To facilitate the audit, it should be ensured that all quality documents are prepared in advance and made readily available for audit on the day including: Local Standard Operating Procedures etc. Ethics documentation Staff training records Equipment maintenance records Sample transfer documents (e.g. MTAs, courier paperwork) Sample tracking records including disposal records HTA Departmental Master File A list of records required under the Human Tissue Act is provided in Appendix 3. This list is not exhaustive, but should provide guidance on what records may be requested on the day. 5 Audit On the day of the audit, the audit will commence with an opening meeting, chaired by the HGO and/or DI. It is important that all key staff attend this meeting. The aim of the opening meeting is to introduce the audit, go through the audit agenda for the day, and requirements of staff. Any findings from previous audits will be discussed and any outstanding actions identified for assessment during the audit. There will also be the opportunity to highlight any proposed changes to the agenda (e.g. if any members of staff are off sick/unavailable, or certain aspects have to be rescheduled). The audit will then begin, in accordance with the audit agenda. Members of the department who are not involved in certain aspects of the audit may leave until required. SOP HTA-1006-UoL Version 1 June 2016 Page 4 of 10 Next Review: June 2018

5 The audit will involve a desk based review of paperwork, and a laboratory based review of the premises, facilities and equipment, examining compliance against the four HTA standards: 1. Consent 2. Governance and Quality 3. Premises, Facilities and Equipment 4. Disposal The audit check-list will be used to facilitate the audit. See Appendix 2 for a copy of the standards with best practice guidance. The audit will also include a sample traceability audit, selecting samples at random from the group s sample tracking system, and retrieving these in the laboratory, followed by a reverse audit, selecting samples at random from the freezer, and finding these in the sample tracking system. Where possible, for samples selected during the sample traceability audit, associated consent forms will also be inspected. This may require a follow-up audit involving clinical staff. Following completion of the audit, there will be a closing meeting to summarise the audit activities, to recognised good practice and discuss any observations and possible corrective actions. 6 Audit report An internal audit report will be issued within fifteen working days of the audit detailing the inspection observations to the PD, Departmental manager and any researchers involved in the audit. Where the report may take longer (e.g. due to further investigations, or follow up audits), this will be communicated with the auditees. Audit reports will be written in sufficient detail to thoroughly document the audit discussions and findings. Where-ever possible, references will be provided to the HTA Standards that each observation relates to, and recommendations provided for a course of action. Audit findings will be categorised as follows: SOP HTA-1006-UoL Version 1 June 2016 Page 5 of 10 Next Review: June 2018

6 Critical shortfall A shortfall which poses a significant risk to human safety and/or dignity or is in breach of the Human Tissue Act 2004 or associated directions Or - A contribution 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. Major shortfall Minor shortfall Other 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 codes of practice, the Human Tissue Act, and other professional and statutory guidelines, or Has the potential to become a critical shortfall unless addressed Or - A combination of a number of minor shortfalls, none of which is major in its own right, but which together could constitute a major shortfall and should be explained and reported as such. A shortfall which cannot be classified as either critical or major, but which indicates a departure from expected standards/good practice. Where a shortfall has not been identified, but areas for improvement have been identified, leading to the auditor providing advice to the auditee on improvements. The first draft of the report (Appendix 1) will be provided to the PD and Department Head for review and the auditee given the opportunity to highlight where any areas may have been misrepresented or missed. Once satisfied that the report provides a true reflection of the inspection findings, the report will be finalised. The HTA Governance Officer will then: Retain the original signed copy of inspection report and any associated documentation. Send a fully copy to the auditee, PD/HTA departmental contact/departmental head and DI. Internal audit reports will not be shown to outside agencies unless required as part of regulatory inspections. 7 Corrective Actions/Preventative Actions (CAPA) SOP HTA-1006-UoL Version 1 June 2016 Page 6 of 10 Next Review: June 2018

7 The auditee should respond to any report observations within twenty (20) working days of receiving the audit report, with an action plan for any corrective/preventative actions required, and expected completion dates. Where complex observations require a more detailed response, or in agreed exceptional circumstances, a longer period (e.g. twenty-five (25) working days) may be assigned, with the agreement of the HGO and/or DI. In the event of a response not being issued within four (4) weeks, a position statement, detailing the reasons why and the expected time frame for completion should be forwarded to the HGO. Once agreed with the HGO, actions will be added to the CAPA table. The HGO will keep a log of all audit findings and CAPA with reminders for completion. As each action is completed, the action taken, completion date and person completing the action should be documented and the information provided to the auditor. The auditor may also request a further audit of the facility to confirm that corrective actions have been implemented. 8 Audit closure On completion of all corrective and preventative actions, the audit will be considered complete. 9 Departmental Self-Inspection In addition to internal inspections from the HTA Governance Officer or suitably trained delegated member of staff from Research Governance office or and/or Designated individual, it is recommended that departments also conduct regular self-inspection audits to assess performance against internal, external and regulatory standards, and react to any changes in regulations. Self-inspection audits may cover more than the HTA Research Licence requirements; however, where a self-inspection is raised to assess compliance under the University s Research HTA Licence, a copy of the self-inspection report should be sent to the HGO as soon as it becomes available. Self-inspection reports may be used to facilitate internal audits by the HGO and/or DI and demonstrate commitment to improving quality systems. 10 Responsibilities SOP HTA-1006-UoL Version 1 June 2016 Page 7 of 10 Next Review: June 2018

8 Responsibility Undertaken by Activity 1. Designated Individual (DI) HTA Governance Officer or equivalent post within the Research Governance Office. Conduct the HTA compliance audits. Ensure audits are completed on a yearly basis. Maintain list of departments operating under HTA licence. Plan and circulate HTA audit schedule. Send audit agenda out before the day of the audit. Audit report to be issued within 15 working days of completion of audit. Retain final audit report and send copies to PD/HTA contact, departmental heads and DI. Keep log of audit findings and corrective action/preventative actions (CAPA) as completed. Close audit once all CAPA actions completed. Lead external HTA audits 2. Person Designated (PD) PD, HTA Departmental contact or equivalent post within the Research Governance Office. Escort HGO and or DI during departmental audit. Identify individuals and arrange availability for audit. Submit all information requested by HGO in a timely manner before start of audit. Book suitable room to conduct audit. Prepare quality documents in advance of audit. (Appendix 3) Review daft report and agree content for circulation. Send response to final report within twenty (20) working days of receiving final audit report. Prepare corrective action/preventative action plan to resolve audit findings. Conduct/arrange self-audits to ensure performance against internal, external and regulatory standards. Provide support when external audits are conducted. 3. All individuals Research scientists, Department lab manager Ensure that there is a clear and robust audit trail from the collection of human material, through processing, storage, use and distribution, to final use/disposal. 4. Designated Individual (DI) Designated Individual (DI) Review of HTA audit schedule. Review and sign off final audit once completed. 11 Monitoring and Audit Criteria SOP HTA-1006-UoL Version 1 June 2016 Page 8 of 10 Next Review: June 2018

9 Key Performance Indicator Review of documented processes Method of Assessment Research Governance HTA Departmental audits. Frequency Annual HTA research governance audit. Lead HTA Research Governance Officer. SOP HTA-1006-UoL Version 1 June 2016 Page 9 of 10 Next Review: June 2018

10 This table is used to track the development and approval of the document and any changes made on revised / reviewed versions. DEVELOPMENT AND APPROVAL RECORD FOR THIS DOCUMENT Author Tracey Edwards Job Title: HTA Research Governance Officer Reviewed College of MBS&P Human Tissue Act Committee by: Approved by: Designated Individual Professor Andrew Wardlaw Date Approved: REVIEW RECORD Date Issue Number Reviewed By Description Of Changes (If Any) DISTRIBUTION RECORD: Date Name Dept Received SOP HTA-1006-UoL Version 1 June 2016 Page 10 of 10 Next Review: June 2018