IIIIIIIIIIIIIIIIII Point of care testing (POCT) Dr K.A.C.Wickramaratne.

IIIIIIIIIIIIIIIIIIPoint of care testing (POCT)

Dr K.A.C.Wickramaratne

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 ......