Quality management, Validation and Accreditation Flashcards
Name 6 components of a quality management system
- Quality planning (goals, objectives, customer requirements)
- Quality leadership (director/ manager- inspire the workforce, team, networking, education & training )
- Quality lab practice (good policies, procedures and people)
- Quality assurance
- Quality control
- Quality improvement
What is quality improvement?
The practice of continuously assessing and adjusting performance using statistically and scientifically accepted procedures.
Eg: product improvement, process improvement, staff improvement
What are SOPs?
Standard operating procedures (SOP)
= written standards for tests to maintain consistency in day to day performance.
SOPs avoid unauthorised variation – document controlled training resource.
What are the components of validation?
- Precision
- Accuracy
- Linearity
- Range of test and Limits of detection
- Carryover
- Uncertainty of measurement
- Robustness
- Sensitivity and specificity
What are the essential components that are assessed in laboratory accreditation?
- Laboratory management and organisation - Director, committee, section heads, safety officer etc. Strategic and business planning
- Staff - numbers, training, competency assessments
- Environment - safety, lighting, power, work areas. Safe system of work. Spaces.
- Equipment (Instruments and reagents) - maintenance, records, calibration, checks e.g. fridge temps, safety, operating instructions; selection, purchasing and management.
- Testing and Methods - Pre-analytical, analytical and post-analytical. Validation, SOPs,
- Quality management system - internal audits, quality leadership, documentation, quality improvement.
- QC and EQA. Corrective actions. - Records, reports, IT system
How is a pathologist involved in laboratory accreditation?
- Receiving end
2. Assessor end
How can a pathologist prepare for accreditation visit? (5)
- *Quality improvement is ongoing - should not be a scramble for a visit.
1. Knowledge - of standards, laboratory practice, tests
2. Leadership and laboratory supervision
3. Involvement - choice of equipment, validation procedures
4. Meetings
5. Training of staff
The pathologist as a laboratory accreditor (5)
- Knowledge of standards
- Confidentiality
- No conflict of interest
- Objective assessment
- Consider “acceptable” vs “best practice”
When is laboratory accreditation performed?
4-yearly cycle of assessment
1st year = big assessment
Annually = surveillance assessment
What is the role of laboratory accreditation?
Is the laboratory operating at an acceptable standard?
==> ensuring that every result/report is correct
Provide constructive advice
Documentation of deficiencies
How can reference intervals be established?
- Use reference intervals already established and validate them in your laboratory e.g. 20 subjects (must ensure same method and similar population). Often these were established a long time ago with different methods and populations.
» can be from manufacturer or another laboratory - Transfer RIs in own laboratory from old method to new method.
- Indirect method “a posteriori” approach. Use data already collected in your lab and use computer programs and statistics to eliminate unhealthy subjects.
- Establish your own RIs - select a statistically sufficient group (a minimum of 120) of healthy reference subjects. Need to collect health and demographic data on each but there is the risk of subclinical disease. Costly. Need informed consent etc.
How do you prepare for an accreditation visit?
Review/be familiar with standards - ISO15189
Review previous accreditation reports - look at non-conformities and recommendations
Address common non-conformities e.g. temperature checks of fridge, SOPs up to date, everything signed.
Document is submitted to IANZ for review before the site visit.
How do you reduce costs in the laboratory?
- Understand costs and finances first.
- Assets
- Liabilities
- Revenues - Review business and strategic plan. Consider future costs and direction.
- Staff = major cost in running lab
- increase automation, consider digital morphology, AI etc.
- reduce over-time and increase part-time contractors
- staff can cover more than one department - Review tests and instruments/equipment and supplies
- look at those which generate money and those that cost money to run. Can some be contacted out?
- batch tests
- instrument purchase vs leasing
- consumables - bulk buying (can liaise with other labs) - Overheads and indirect costs
Building - lease, maintenance, upgrades, security, cleaning etc.
Sustainability - large expense is power (fridges, ventilation, instruments etc). Need to have energy-saving plans
Lab design - flexible work benches, offices etc. so the spaces can be used for more than one purpose
