Quality Assurance Flashcards
What is Quality Control?
checking that equipment or investigations/tests are running correctly
What factors could affect test results?
reagents
operator
equipment (old or new?)
Why is quality control important?
- informs us if equipment is working properly
- reduces risk of false positives/negatives
What is a Levey-Jennings plot?
- It is a graph that plots QC values for a lab test to check if it is performing optimally
- when a test is first validated and verified, 20 in house control samples will be run to get the mean and standard deviation
What are the westgard rules?
- they determine if a run can be accepted/rejected
e.g: if a run is +/- 3 standard deviations away from the mean the run is rejected, if the run is +/- 2 standard deviations away from the mean, this rule is used as a warning rule to trigger inspection of the control data
What is Quality Assurance?
- This process involves monitoring all practices and procedures associated with the service provided, not just the lab assay procedure
- It includes pre-analytical, analytical and post-analytical procedures
What occurs in the Pre-Analytical stage?
- request is generated and sample is specified
- appropriate collection vessel is selected
- sample is taken under appropriate conditions
- sample is labelled
- sample is stored correctly and delivered to lab immediately
What occurs at the analytical stage?
- sample is received by specimen reception staff
- SOPs are followed
- reagent storage and assay conditions are checked regularly
- quality controls are included
What can go wrong during the analytical stage?
- quality control can be mismanaged
- out of date reagents
- cleanliness of machines
- are staff trained and competent
What occurs at the Post-Analytical Stage?
- results are recorded in a clear and logical fashion
- results are provided by telephone, in a timely manner
- a clear written report is delivered to the correct site
What are some Quality Indicators?
1) Turnaround Time: time from specimen arrival in laboratory to the results being issued
2) Other QI’s: Audits, Document Reviews, Mandatory Training
What are some factors that can affect turnaround time?
- nature of the test: bacterial cultures/histopathology can take time
- context of test: A&E samples will require a quick TAT, whilst routine antenatal screening is less urgent
What are the two types of quality assessments?
1) Internal Quality Assessments
2) External Quality Assessment
What is an IQA?
- used to monitor precision of tests, carried out daily, compares with diff results of the same hospital
- checks the whole process from specimen reception to reporting using a ‘blind’ test of a sample which has been run previously
- results can show changes in test performance/ calibration issues, issues with reagents
What is an EQA?
- National External Quality Assessment Schemes (NEQAS) provides samples
- samples are run and then sent back to NEQAS and scored based on accuracy
- done weekly/monthly
- results are compared to other labs
- can show errors/ problems with equipment
- can highlight areas for improvement and pick up on training issues
What is the Quality Management System?
- helps to coordinate and direct an organisations activities to meet customer and regulatory requirements and improve its effectiveness on a continuous basis
- all hospitals will have a QMS and quality manager
What does a Quality Management System take into account?
1) Policy
2) Plans and Objectives
3) Processes: what happens in practice
4) Procedures: provide the info to conduct the processes
5) Records: evidence that procedures are carried out
What are Audits?
- they assess the quality of a test
What are the types of Audits?
1) Vertical Audit: an audit of the different processes/assays in one department
2) Horizontal Audit: an audit of the same process across different departments
3) Examination/Witness audit: an audit in which the process of a specific assay is witnessed and viewed
What is UKAS (United Kingdom Accreditation Service)
- governance body in pathology
- labs can be accredited by UKAS
- they will visit hospitals to see if they are complying with set standards
What do UKAS audits assess?
- they assess and accredit the competence of a lab to carry out: calibration, tests, types of tests, sampling activities
How are labs accredited?
- initially a lab will send UKAS a copy of its quality manual, as well as info on its actives, equipment and staff
- pre-checks and a lab assessment
- summary of findings
What is Care Quality Commission?
- they register care providers, monitor and inspect services, take action to protect people who use services
What are the CQC values?
- Excellence
- Caring
- Integrity
- Teamwork
