Development↦Biobanking↦Quality Control↦Quality Control Indicators
Was betrifft es? Warum ist das wichtig?
Quality Control (QC) is an integral part of a Quality Management System. An aspect of QC in biobanking is the definition and measurement of Quality-Control-Indicators. QC-Indicators are performance indicators regarding critical biobanking steps that must be monitored and controlled.
The performance of QC-indicators:
- Allow for the ongoing monitoring of biobank operational processes
- Indicate whether the compliance of Quality expectations are met
- Feed into the implementation of biobanking improvement measures
QC-Indicators provide information on the compliance with:
- Staff qualification and training
- Sample workflow processes (e.g. process relevant SOPs/WIs)
- Biobank governance,
- Ethics requirements (e.g. EC, Declaration of Taipei), regulatory requirements (e.g. Swiss law), international standards (e.g. ISO)
- Database entry guidelines (e.g. BIMS)
- Safety guidelines for both donors, staff, and environment
- Facility management and maintenance guidelines
- The reporting and documentation of non-conformities (e.g. non-compliance)
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Example: DNA/RNA in a biological sample
- Aim: to ensure that DNA/RNA analytical results obtained at different time points are comparable
- Requirement: to comply with ISO 20387 defining validated sample processing procedures for the preservation of tissue DNA and RNA.
- QC-indicator: a minimal delta (e.g. to ensure elapsed time between sample collection and processing is less than 45 minutes)
- QC-Indicator result: Calculated elapsed time between sample collection and processing
- Documentation:
- Time-lapse less than 45 minutes. QC-Indicator compliance
- Time-lapse more than 45 minutes. Non-adherence to required QC-Indicator, and occurrence of non-conformity. Implementation of follow-up procedures (e.g. sample destruction)
Was muss ich befolgen?
Define the processes of your biobank. Focus on:
- Organizational Requirements (e.g. reference to biobank regulation)
- Resource requirements (e.g. qualified staff, facilities, BIMS)
- Sample workflow requirements
Establish risk-based QC-steps:
- Defined QC-Indicators that must be complied with in order to ensure the quality of your biobank
- In the event of non-conformity, plan applicable risk control-measures
According to your QC strategy:
- Document risks management procedures in a SOP/WI, or in a project/study relevant Risk Assessment Form
- Plan additional QC risk control-measures, such as:
- Internal biobank audits (e.g. SBP Quality Labels)
- Management reviews
Example of Biological Material (BM) QC-steps with defined QC-Indicators:
- Cell viability: minimum % of viable cells required for analysis
- Yield: minimum amount of total cells needed for diagnosis
- Volume: minimum amount of collected BM (e.g. blood or serum) needed for analysis
- Sterility: presence of non-contaminated cells
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Examples of identified biobanking risks and the implementation of risk control-measures:
- Facility and equipment:
- Risks: freezer break-down, incorrect measurement of pipettes and scales, lack of processing solutions
- Risk control-measures: freezer emergency plan, regular calibration of measuring equipment, regular inventory checks
- Donor and staff safety:
- Risks: staff exposed to toxic chemicals, lack of donor consent
- Risk control-measures: staff trainings, implementation of safety procedures, and of informed consent procedures (e.g. documented in SOPs/WIs)
- Data security:
- Risk: accidental disclosure of data to the public, accidental deletion of data
- Risk control-measures: BIMS with access control and audit trail
Wo kann ich Hilfe anfordern?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic - see in particular
- SBP Labels: Quality with biobanking best practice standards
SBP Documents
SOPs, Forms and Templates – see in particular
- Quality control strategy implementation SOP
- Quality control results
- Risk management SOP
References
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost)- General Requirements for Biobanking – see in particular section
- 7.8 Quality control of BM and associated data
- Quality management system requirements
Declaration of Taipei – see in particular principles
- 1 – 7 Preamble