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

2.  Definition  Goals of POCT  Uses  Is it a rapid test?  Tests available  Advantages  Disadvantages  Management issues  How to assure quality  Accreditation of POCT

3. 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.

4. 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

5. 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

6. 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.

8. 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.

10. 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 !)

11. 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-

12. 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

13.  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

15. 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

18. 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......