Post on 28-Dec-2015
Definition Goals of POCT Uses Is it a rapid test? Tests available Advantages Disadvantages Management issues How to assure quality Accreditation of POCT
What is POCT ?
Analytical test performed outside the laboratory by health care providers
Performance of tests –“bed side”
“POCT is medical testing at or near the site of care.”
“Point‐of‐care testing (POCT) refers to any testing conducted outside a lab, in a hospital, in a clinic or by a health care organization providing ambulatory care.
Goals of POCT
Improve quality of patient care Enhance efficiency of patient care Increase physician and patient satisfaction Improve patient education Decrease liability risk ? ? Minimize burden at central level
Where POCT is used?
ICU, Accident and emergency department Operating theatres Dialysis units, Neonatal units OPD, casualty wards, domestic care (health
care team) Other special treatment centers – DF Mass disasters
Does the POCT need to be an instrument‐
free dipstick or RDT? • Widely used ASSURED criteria for rapid tests by WHO:
A = affordable
S = sensitive
S = specific
U = user friendly -simple to perform
R = robust and rapid (results available in less than 30 minutes)
E = equipment free
D = deliverable to those who need the test •
The type of device does not define a POCT test. POCT range from simplest dipsticks to sophisticated automated molecular tests on portable analysers and imaging systems.
What tests available?POCT ranges between three levels of complexity,
simple procedures - capillary glucose testing, urine dipstick
moderate‐complexity procedures - microscopy of urine
or high‐complexity procedures - PCR, TEG, resonant micro sensing platform for
ultrasonic characterization of blood coagulation.
Advantages
Identify critical diagnosis / screen quickly Evidence available on site Speed – less turnaround time ! Smaller sample volume – less waste Full time equivalent (FTI) Impact
doctor patient confidence
Improved outcome and patient education
cost saving – (not always !)
Disadvantages
Lower accuracy and precision – future can be promising
Less skilled personnel to perform tests – can be trained
Higher supply cost - ??
Lack of comparability – need standardization
Lack of data systems -
Difficulty in assuring quality-
Difficulty in managing testing-
Management issues
Who should perform ? Doctor or a nursing officer - training
Responsibility ? Ward staff or Laboratory
Documentation and monitoring Test results not linked to devices, no printouts, no signatures,
no validation !
Maintenance
Quality assurance – Test method – validation – ? Compared with gold
standard ?
Test calibration – metrological traceability
IQC - Very difficult –
EQA – not available freely
Market driven concerns Highly competitive and rapidly evolving
The device available today may not be usable next year
Repetition in both POCT and central – test duplication
How to assure quality
Selection of a validated method with traceability
method with a reasonable accuracy,
precision and measurement uncertainty
Selection of a method with ability to monitor performance (IQC and EQA)
Setting up POCT management team
Training of personnel
Establishing documentation system
Preparation of SOPs/manuals
Accreditation of POCT.! Accreditation as per ISO 22870 ; Point of care testing
requirements for quality and competence
Similar to ISO 15189
All the requirements of ISO 15189 and ISO 22870 Management requirements
QMS, quality objectives, preventive, corrective ,review
Technical requirements Personnel , training, accommodation and environment,
equipment, pre- examination, examination, post examination ......