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Guide to the Governance & Quality Systems Standards
25 March 2009
Teena Chowdhury, Regulation Manager
Aims of this session
To outline what the HTA expects from you regarding Governance & Quality Systems (GQS) and why
To outline the DI’s responsibilities with respect to the GQS standards
Overview of the GQS standards
Eight GQS standards 70 sub-standards
Inspected over 100 human application establishments 162 conditions – GQS standards 807 advice & guidance – GQS standards
The GQS standards
GQ1: documented policies and procedures GQ2: quality management and audit GQ3: training and CPD GQ4: record management GQ5: donor selection GQ6: traceability GQ7: adverse events and adverse reactions GQ8: risk assessments
GQ1: All aspects of the establishment’s work are supported by ratified documented policies and procedures as part of the overall governance process
DI responsibilities
Procedures for all licensable activities
Procedures to ensure the integrity of tissues and cells
Procedures to minimise the risk of contamination
SOPs required by the HTA Directions Confidentiality Controlled access to health data/records Record control Donation & procurement (incl. consent), packaging, labeling,
transportation, distribution, receipt Receipt of tissues/cells Management of procured equipment/materials Recall Storage Disposal Control of packaging/storage areas Termination Traceability Serious Adverse Events and Reactions (SAEARS) Personnel management Maintenance of premises/facilities
GQ2: There is a documented system of quality management and audit
DI responsibilities
HTA Directions require DIs to have a quality management system in place which includes:
a quality manual SOPs as required by the HTA Directions guidelines training and reference manuals reporting forms donor records information on the final destination of tissues / cells
Quality manual - information to include:
organisation and responsibilities an outline of the structure of the system list / reference to location of policies and SOPs training and development records minutes risk assessments job descriptions
The “Quality Manager”
Reports to management on the efficacy of the quality system
Ensures audit and quality review are carried out
Ensures personnel are complying to the quality system
Does not need to be solely appointed for the purpose of quality management
Audit HTA compliance report – updated self
assessment every six months
Schedule of internal audits: record audit - are records legible and complete? process audit - are staff working to SOPs? traceability audit - can material be traced from donor to
recipient / disposal?
Independent audit every two years
GQ3: Staff are appropriately qualified and trained in techniques relevant to their work and are continuously updating their skills
Statutory role to ensure suitable persons work under the licence
Evidence that suitable persons work under the licence: induction trained personnel work under the licence CPD knowledge of the scientific and ethical principles relevant
to their work
Staffing levels
DI responsibilities
GQ4: There is a systematic and planned approach to the management of records
Why is this a requirement?
Major objective of the EUTCD is to ensure full traceability of tissues / cells
All relevant data must be documented, recorded and stored on validated systems
Contingency plan for the storage of records Audit for completeness, legibility and accuracy Computerised records backed up
Retention of records
Raw data which is critical to the safety and quality of tissues and cells must be kept for 10 years after the use, expiry date or disposal of tissues and/or cells
The minimum data to ensure traceability from donor to recipient must be kept for 30 years after the use, expiry date or disposal of tissues and / or cells
GQ5: There are documented procedures for donor selection and exclusion, including donor criteria
DI responsibilities
Donors are selected based on an analysis of the risks of the application of specific tissues / cells
Risks identified by: physical examination review of medical and behavioural history biological testing post-mortem examination (for deceased donors)
Donor selection criteria
cause of death unknown (in deceased donors)
history of diseases which may affect the quality and safety of tissues and cells (e.g. risk factors for CJD, systemic infection, degenerative neurological disorders)
if the above is present donors must be excluded unless justified by a documented risk assessment approved by the DI
Donor testing requirements
HIV 1 and 2 Anti-HIV-1,2
Hepatitis B HBsAg Anti HBc
Hepatitis C Anti-HCV-Ab
Syphilis
Implement to higher standards but not lower
Minimum requirements – as new tests come on to the market these testing requirements may change
Why is this a requirement?
To minimise the risk of disease transmission to the recipient
To reduce the risk of cross-contamination during the processing and storage of samples
GQ6: A coding and records system facilitates traceability of tissues and cells, ensuring a robust audit trail
DI responsibilities
Ensure traceability of tissues and cells from donor to recipient and vice versa
Ensure traceability of all products and material coming into contact with the tissues and cells
Procedures must be in place to ensure: unique and accurate identification of each donor,
donation and all products associated with the donation
all relevant data relating to products and materials coming into contact with tissues / cells received and distributed is traceable from donor to recipient, and vice versa
labelling of packages and containers containing tissues / cells received and distributed
Why is this a requirement?
So tissues and cells can be identified in the event of a recall
To protect patients e.g. in the event of infected tissue being issued
This is complex because activities may involve: global procurement of tissues and cells transfer to another country for processing or storage clinical application in another country
GQ7: There are systems to ensure that all adverse events, reactions and / or incidents are investigated promptly
Procedures must be in place to:
ensure adverse events and reactions are identified, reported, investigated and recorded and corrective or preventative actions are documented
identify and decide the fate of affected tissues / cells
receive and distribute national and local information (e.g. HTA regulatory alerts)
recall tissues / cells which include a description of responsibilities and actions to be taken in the event of a recall
report SAEARs online
GQ8: Risk assessments of the establishment’s practices and processes are completed regularly and
are recorded and monitored appropriately
DI responsibilities
All practices and processes are risk assessed
Review risk assessments at least annually and whenever changes occur which may affect the quality and safety of tissues / cells
Ensure staff can access these risk assessments
DI responsibilities
A documented risk assessment must be undertaken to determine the fate of all stored tissues and cells following:
the introduction of any new donor selection or testing criterion; or
any significantly modified processing step that enhances safety or quality
Questions?
www.hta.gov.uk
