Lecture 5A & B Flashcards
What is the 3 main frame of quality management system
Pre-examination
examination
Post-examination
What is the optimal path of workflow
Procedures:
Processes:
Policies
What is the procedure of the workflow
Standard operating
procedures. “How to do it”
What is the process of the workflow
carrying out quality
policies to transform inputs into
outputs. “How it happens”
What is the policies of the workflow
: documented
statement of overall intentions
and direction of the
organization. “What to do”
What part of the workflow is in the laboratory section manual
Procedures
Which part of the workflow is in the quality system manual
Processes
Policies:
What does the lab section manual step-by-step protocal ensures
- Consistency (multiple staff)
- Accuracy (not relying upon memory)
- Quality (complies with standard)
What is Document Controlled Laboratory Manual
making sure all the documents are up to dated
and make sure all things done in the lab are documented
Traceability
What is equipment log and maintenance in lab
• Asset register
• Maintenance schedule
• Cleaning roster
• Calibration (e.g. micropipettes every 3 months)
• Metrological traceability:
result can be related to a reference through documented
unbroken chain of calibrations e.g. balance
What is quality assurance
• Planned and systematic set of quality activities focused
on providing confidence that quality requirements will
be fulfilled
• Quality assurance panel (QAP), proficiency test
• Quality assurance versus quality control?
What is the Enrolment in Quality Assurance Panels
- Accreditation requirement
- Education
- Verify methods & procedures
- Identify problems
- Assess performance
- Comparison with peers
- Demonstrate competence
What are the few quality management system
Section manual Biosafety SOPs Staff training Quality system manual Defined management structure GLP Document control Internal audits Quality assurance panels Quality control Method validation Equipment maintenance Result recording & reporting
What is gap analysis
Implementation of changes required to
improve the system will come from
audits, QAP, management review, quality
indicators (e.g. turnaround time)
Outdated
What is PDCA
Plan
Do
Check
Act
What is (ISO
• International Organization for Standardization (ISO)
• Standards Australia: development and adoption of
standards in Australia but do not enforce, regulate or
certify compliance with these standards
What is the international standard organization the australia use
• National Association of Testing Authorities (NATA)
• Established in Australia in 1947, first laboratory
accreditation body
• NATA determines a facility’s technical competence
based on the relevant international standard
• Only endorsed assessing body for pathology
accreditation in Australia
What is Laboratory biosafety
containment principles, technologies, and practices implemented to prevent unintentional exposure to pathogens and toxins, or their unintentional release
What is Laboratory biosecurity
protection,
control and accountability for valuable
biological materials within laboratories, in
order to prevent their unauthorized
access, loss, theft, misuse, diversion, or
intentional release
What are the two categories based on scientific assessment of risk during transportation
- Category A: capable of causing permanent disability, lifethreatening or fatal disease in otherwise healthy humans or animals
eg. Avian paramyxovirus type 1 – velogenic Newcastle disease virus - Category B: does not meet the criteria for inclusion in Category A
eg. swabs for investigation of equine influenza infection; stool specimens for
diagnostic testing
What SSBA
Security Sensitive Biological Agents
• National standards for the handling, storage, disposal and
transport of SSBA and suspected SSBA
What are the two tiers of Security Sensitive Biological Agents (SSBA)?
• Tier 1 agents pose the highest security risk
e.g. foot-and-mouth disease virus, highly pathogenic influenza virus
infecting humans
• Tier 2 agents pose a high security risk
e.g. sheep pox virus and goat pox virus, Yellow fever virus
What is Equine influenza
Outbreak 2007 • Exotic disease in Australia • Routine vaccination not permitted except for horses intended for export • Largest exotic animal disease event in Australia
What is the main detection of equine influenza virus
Detection of virus or virus product from nasal swabs
What are the type of Diagnostic Laboratory Tests
- Antigen/pathogen detection: ELISA, PCR, EM
- Serology: single or paired sample
- Histopathology
- Culture (tropism)
What are the factors on Diagnostic Laboratory Tests
- Specificity including wild vs vaccine
- Sensitivity
- Validation
- Controls
- Timeliness
What is the reservoir for Global Rinderpest
• Disease of cloven-hoofed animals, cattle most
important reservoir
• Morbillivirus related to viruses causing peste
des petits ruminants, canine distemper &
measles
• Differential diagnosis includes bovine viral
diarrhea and foot-and-mouth disease
What is the AMP model
Biorisk Management =
Assessment + Mitigation +
Performance
Waht is the likelihood and consequences of risk
Likelihood
Factors that affect
whether or not the
incident happens
Consequences
Factors that affect
the severity of the
incident
What is the Mitigation: hierarchy of controls
Elimination or Substitution Engineering Controls Administrative Controls Practices and Procedures Personal Protective Equipment
What is the Assessment of biorisk management
Risk identification
Hazard/threat identification
Likelihood evaluation
Consequences evaluation
What is Mitigation of biorisk management
Elimination or Substitution Engineering Controls Administrative Control Practices and Procedures Personal Protective Equipment
What is the performance of biorisk management
Gap analysis
