POCT, LIS, New Analyser/Service, Outage Flashcards
What does POCT refer to?
Locations? Devices?
Any testing that is performed outside of the hospital laboratory. The test result is available without the sample being sent to the laboratory.
Locations include - home, GP, pharmacy, ICU, outpatient clinics, theatre
Devices - bench top, portable/hand-held
What are some advantages of POCT? (5)
- Fast TAT - prompt therapy can be initiated
- Convenient
- Testing is usually simple
- Reduced problems with specimen transport and identification
- Small volume sample
What are some of the challenges with POCT? (5)
- Potential for inaccurate results:
- calibration
- QC
- staff not adhering/complying to protocols - Problems with over-testing/investigating
- Staff are non-laboratory workers - need adequate training, may be problems with adherence to protocols, documentation of QC
- Flags on bench top analysers may be limited
- Possible medicolegal and safety issues
What should POCT do?
POCT should generate results that are comparable to those of the local laboratory.
Responsibilities of POCT team/lab manager (5)
- Implementation of POCT
- QC and EQA
- Monitoring and auditing
- Documentation on all aspects
- Health and Safety
Discuss how you would implement a new POCT system.
How to implement a new POCT
- Need a multidisciplinary team for implementation and running
- POCT coordinator, Key Operator, Clinical nurse manager of ward/department
- Members depend on the location and type of POCT.
- POCT Management Team - Pre-acquisition assessment - Identify the need for POCT
- New test/new methodology/replace equipment
- Screening vs diagnostic vs both
- Benefit analysis:
- what is the clinical need and what are the alternatives?
- what will it offer over standard laboratory testing?
- TAT
- cost savings
- How many people will use it?
- Anticipated test volumes? (per day, per week etc.) - Performance assessment of the device(s).
- Consider appropriateness, cost-effectiveness, sensitivity and specificity of the test as well as precision, accuracy and reliability
- Consider size, functions, cost, reagents, waste, ease of use, safety, how QC and calibration are performed, interface with LIS
- Precision, accuracy, reliability
Once the POC test and device has been chosen, the POCT team must next…
- Validation of methodology and test performance
- validation report
- compare results to main laboratory - Work out the results interpretation
- normal range, highs and lows, actions to be taken - Development of all SOPs, manuals, troubleshooting guides, H&S
- Training of all users - need a certification process
- how many people will use it?
- Most problems in POCT are preanalytical, therefore a preanalytical SOP is very important - Develop a monitoring and auditing program
- Equipment maintenance and cleaning
- Reagent records e.g. batch numbers, expiry dates - Ensure the POCT system has QC and is part of the EQA program
- Each day the item is used QC should be performed. Key operator is responsible for results
- Results sent to POCT coordinator and results kept for specified length of time (7 years)
What should be done if QC results are out of range for POCT?
Is this a problem with the control material or the test?
First check the Control System:
⇒ Check that the correct control materials have been used, are in date, have been properly stored and have been properly prepared with sufficient volume.
Look at different controls (low, normal and high) ⇒ all out suggests systematic error
Re-run using fresh QC material along with existing QC material ⇒ both out suggests systematic error
- Shut down POCT until fault has been corrected. Make a sign “Out of Order” and inform all staff.
- All tests to be performed in the main laboratory
- Review all tests performed after last normal QC and inform clinicians. May need to arrange repeats.
Discuss how you would evaluate a new analyser for your laboratory.
Assess instrument requirements
- Clinical and technical teams required.
Instrument needs to meet the clinical and laboratory requirements - how many samples/tests a day, range of tests required, number of tests per sample, level of automation.
review other labs
- Costs - purchasing vs leasing, set-up, running, consumables, cost per test. Ideally want a cost-benefit.
- Environment and physical requirements - size, dimensions, power/water/compressed air. Does lab need modifying?
- Safety - noise, vibration, handling of chemicals
- Operation of instrument
- Assess operation manuals and guides.
- Ease of use? - Staff training.
- IT requirements. Level of automation. Integration with LIS.
- Maintenance and service requirements. Is there a service contract with with the instrument?
Then perform a validation study: Sensitivity, specificity, accuracy, precision, range and linearity, carry-over, robustness How does instrument perform in EQA? TAT? Reliability
How do you determine the accuracy of an instrument?
Accuracy = comparability.
Run large numbers against existing instrument
How do you determine the precision of an instrument?
Precision = getting the same result on repeated testing.
Example would be running tests each day for 5 days. Repeat run 3 times each day. Each run contains normal, high and low.
Suppliers will provide a CV (coefficient of variation) - check to see if this is correct.
How do you establish reference intervals?
Can verify manufacturer’s reference intervals (less time consuming) or do own ones. E.g need large population of normal - must stratify by age and sex and determine the population is healthy and representative.
Principles of implementation of a new instrument in your laboratory?
- Physical/environmental - size/dimensions, water/power/gas requirements
- Develop SOPs and guidelines from pre-analytical to post-analytical phase. Operating manuals, critical values, trouble-shooting etc.
- Staff training, competency assessments, number of staff required
- Calibration of instrument
- Instrument validation - sensitivity, specificity, accuracy, precision, range and linearity, reference intervals, carryover, what to do if out of range. Critical values.
- Develop QC and EQA programmes
- IT requirements, interfaces, incorporation into LIS
- Maintenance and servicing programme
What factors should be considered when setting up a satellite laboratory?
- What population will the laboratory serve?
- What services are provided in the hospital? CTSU? ICU? Renal? Obstetric?
- What is the population? Age/Size/Fluctuations
- Will the laboratory operate 24/7? - What tests will be performed on site vs send-away? Manual vs automatic?
- Anticipated test volumes? - Instrumentation?
- Size of laboratory, number of instruments?
- Physical requirements of instruments - noise, vibration, power, gas - Costs of laboratory set up, including building, instrument purchasing, staff training, maintenance
- Staffing - how many? On site after hours vs off-site?
- Staff training - Development of SOPs and guidelines including safety
- Instrument validation
- Establishment of QA programme linked back to main laboratory. Need to have Quality Management System.
- IT requirements - incorporated into LIS, linked with main laboratory
- Servicing and maintenance program
- Laboratory management
- Accreditation - IANZ
What is a LIS?
Laboratory information system is an integral part of a modern laboratory. In most laboratories, it is not only a means to track samples but a software system that manages many aspects of laboratory informatics.
How would you choose a new LIS?
Committee, Assess requirements, Document work flow of laboratory before looking a LIS options
- Consider requirements of the laboratory and what you would like LIS to cover
- Sample tracking (pre-analytical to post-analytical)
- Equipment and instruments e.g. calibration and servicing, maintenance, inventory. LIS may feed info into automated instruments and receive data from it.
- IT requirements e.g. interfaces, data management, mobile apps; intuitive, easy to use
- Security
- Quality management system e.g QC, EQA, documents
- Staff - training
- Administrative and financial - Cost - modules, how customised you want the LIS, consider upfront and ongoing costs.
- Implementation - ideally would like it to be easy to implement. Consider staff training required.
- 24/7 Service/Help desk
- Ability of the LIS to evolve
