1. Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

2. Point of Care testing (POCT) Tests that are performed at the bedside..near patient.. physician office = Point of care. All diagnostic tests evolved from Point of care Example is urine test at the bedside> moved to>>side room>>moved inside the lab Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

3. POCT Technology New technological innovation is delivering – Improved – Simple – Shorter analysis time – Smaller Devices Laboratory concerns – Non-lab personnel carrying out lab work – Quality Assurance – Encroaching on the lab territory 3 Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

4. Evolution of healthcare and laboratory medicine Future for health care provider and POCT Reversal of Centralization, since centralization can lengthen the diagnostic decision But more economically from the lab standard 4 Home Doctors clinic Hospital

5. Doctor ↔ PatientPrepare request formPhlebotomySample transportRegister samplePrepare sampleAnalyze sampleQuality controlValidate result Report resultTransmit resultRecord result in EMR 5

6. POCT tests designed to be used at or near the site where the patient is located, that do not require permanent dedicated space, are performed outside the physical facilities of the clinical laboratories and that is performed by non-laboratory personnel. College of American Pathologists (CAP) Point of Care Testing Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

7. POCT HMC Policy 7211 The policy is formulated for all Hamad Medical Corporation services and staff for the establishment of a safe and functional POCT program. It is for all laboratory tests approved by the POCT Coordinating and Steering Committee.

8. The availability of the result within minutes of asking the clinical question improves the outcome BUT have to ensure safety and quality Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

10. Risk is the chance of suffering harm / error and it can be estimated from the probability of the event and the severity of the harm. Safe POCT is achieved by application of the approved policy, procedures and practices to the task of analysing, evaluation, controlling and monitoring risk. Risk management of POCT activities is by validating the tests before use, trouble shooting of failed QC, performing maintenance, ensuring operators are trained, inventory control. Defining Risk for POCT

11. Main risks of POCT Unqualified lab users-Nurses – Have minimum lab skills perform POCT testing – They are focused on patient care Quality Control – A liquid sample of known concentration – Preferably two levels are used to prove stability of the testing. – It detects systemic error not random error Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

12. Role of POCT co-ordiator Training Competency assessment Quality control, internal and external Writing and reviewing the Operating procedures Devices and inventory control Ensuring Results are – reported with an appropriate reference ranges – documented with patient record which are accessible by all care giver Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

14. Anti Coagulation POCT PT/INR ACT TEG Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

15. Why do we need anticoagulant study? Clotting is associated with disease conditions  Artificial heart valve replacement  Myocardial Ischaemia  Atrial fibrillation (AF)  Deep Vein Thrombosis (DVT)  Pulmonary embolus  Hereditary disorders ~ deficiencies in blood proteins or production of antibodies that cause the blood to clot or prevent the blood from clotting Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

16. PT = Prothrombin Time. It is a measure of how quickly blood clots. INR = International Normalized Ratio The ideal target INR range will vary from person to person depending on a variety of factors such as; Reason for taking anticoagulants Medical conditions Other issues. The traditional way to run a PT-INR test is to have blood drawn and sent to a lab, where the test is conducted Why Do We Need PT/INR Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

17. PT/INR Measure of the extrinsic pathway POCT devices strips containing thromboplastin reagents (variable sources) Fresh whole blood Clot detection – The lab uses either optical or mechanical means – POCT Capillary or pump-induced movement Oscillation change of a magnetic particle Electro-current by alteration of fluorescence Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

18. HMC POCT PT/INR devices InstrumentManufacturerFresh whole blood Citrated whole blood Citrated plasma Sample size CoagCheckRocheYesNo 10 – 25ul HemochronITCYesNo 25ul Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

19. Roche CoaguChek XS Pro System Components CoaguChek XS Pro Handheld Base Unit* Handheld Battery Pack * Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section 19

20. Principle The CoaguChek test strip contains recombinant thromboplastin reagent. When the whole blood sample is applied, the reagent is solved and an electrochemical reaction takes place which is transformed into a clotting time value being displayed on the meter screen in INR values. The international sensitivity index (ISI) for the system has been established as 1 Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

21. Hemochron Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

22. Hemochron Signature Elite Components Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section 22

23. Hemochron Jr. Test Cuvettes Test type is read automatically from the cuvette. CuvetteIntended UseSpecimenReporting Unit ACT-LR Monitors low to moderate heparin doses up to 2.5 units/mL of blood. Used in procedures such as cardiac catherization, Extracorporeal Membrane Oxygenation (ECMO), dialysis and Pertaneous Transluminal Cornary Angioplasty. Whole bloodCelite Equivalent Seconds ACT+ Monitors moderate to high levels of heparin (1- 6 units/mL ). Unaffected by aprotinin upto 500 KIU/mL of blood, hypothermia, and hemodilution. Whole bloodCelite Equivalent Seconds Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

24. ACT Coagulation initiated by an activator Clot detection is change in pump driven blood movement Strong activator kaolin or celite Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

25. Why use ACT Monitoring hemostatsis for heparin anticoagulant therapy Bleeding clotting Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

26. Rapid TAT Rapidly adjust anticoagulant dose Heparin – half life varies by patient – Dose required varies by patient – Potency varies by lot Direct thrombin inhibitors – very short half life – Require immediate intervention – No antidote available Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

27. ACT Cardiac surgery Percutaneous coronary intervention (PCI) Interventional cardiology ECMO Critical care Interventional radiology Electrophysiology Vascular surgery Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

28. ACT Activated clotting time POC Only Low, moderate or high dose heparin System dependent APTT Activated partial thromboplastin time Laboratory Low dose heparin only System dependent upper limit Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

29. Challenges Variation in tests results based on the device used INR corrects for variation, not with ACT End-user knowledge of the pre-analytical variables- Training – Sample type: cap avoid messaging, arterial or venous avoid trauma – Size: – timing of collection-immediately Quality assurances Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

30. TEG measures viscoelastic properties (viscosity) of whole blood. The clot viscoelasticity depends on – Fibrinogen – Platelets – Coagulation – Fibrinolytic proteins Thromboelastograph (TEG)

31. TEG TEG- abnormal hemostasis and fibronolysis Hepatic disease Cardiac Surgery ECMO Assessment of bleeding peri-operatively and following trauma Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section

32. Viscoelastometric POC MAY be useful to help determine if bleeding is because of a problem with the blood’s ability to clot, or because of a surgical bleed. This helps the right treatment to stop the bleeding. Using these systems MAY mean that patients are less likely to need a blood transfusion during surgery or need more operations to investigate further bleeding. TEG is recommended to help monitor blood clotting during and after heart surgery by healthcare professionals who have had appropriate training NICE August 2014 Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section TEG and NICE guidelines

33. THANK YOU Department of Laboratory Medicine & Pathology Point of Care Testing (POCT) Section