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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
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Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Dec 19, 2015

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Page 1: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Safe Anticoagulation Management using Point of

Care

Dr. Tony AvadesSr. Consultant and Head of Chemistry,

Endocrinology and POCT SectionsDLMP

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 2: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 3: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 4: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Evolution of healthcare and laboratory medicine

Future for health care provider and POCT

Reversal of Centralization, since centralization can lengthen the diagnostic decisionBut more economically from the lab standard

4

Home

Doctors clinic

Hospital

Page 5: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

5

Page 6: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

• 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 & PathologyPoint of Care Testing (POCT) Section

Page 7: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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.

Page 8: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 9: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.
Page 10: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

• 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

Page 11: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 12: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 13: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.
Page 14: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Anti Coagulation POCT

• PT/INR• ACT• TEG

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 15: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Why do we need anticoagulant study?

Clotting is associated with disease conditionsArtificial heart valve replacementMyocardial IschaemiaAtrial 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 & PathologyPoint of Care Testing (POCT) Section

Page 16: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

• 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 & PathologyPoint of Care Testing (POCT) Section

Page 17: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 18: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

HMC POCT PT/INR devices

Instrument Manufacturer Fresh whole blood

Citrated whole blood

Citrated plasma

Sample size

CoagCheck Roche Yes No No 10 – 25ul

Hemochron ITC Yes No No 25ul

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 19: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Roche CoaguChek XS ProSystem Components CoaguChek XS Pro

Handheld Base Unit*

Handheld Battery Pack*

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section 19

Page 20: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 & PathologyPoint of Care Testing (POCT) Section

Page 21: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Hemochron

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 22: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Hemochron Signature Elite Components

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section 22

Page 23: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Hemochron Jr. Test Cuvettes

• Test type is read automatically from the cuvette. Cuvette Intended Use Specimen Reporting 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 blood Celite 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 blood Celite Equivalent Seconds

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 24: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

ACT

• Coagulation initiated by an activator• Clot detection is change in pump driven blood

movement• Strong activator kaolin or celite

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 25: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Why use ACT

• Monitoring hemostatsis for heparin anticoagulant therapy

Bleeding clotting

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 26: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

• 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 & PathologyPoint of Care Testing (POCT) Section

Page 27: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

ACT• Cardiac surgery• Percutaneous coronary intervention (PCI)• Interventional cardiology• ECMO• Critical care• Interventional radiology• Electrophysiology• Vascular surgery

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 28: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 29: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

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 assurancesDepartment of Laboratory Medicine & Pathology

Point of Care Testing (POCT) Section

Page 30: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

• TEG measures viscoelastic properties (viscosity) of whole blood.

• The clot viscoelasticity depends on– Fibrinogen– Platelets– Coagulation– Fibrinolytic proteins

Thromboelastograph (TEG)

Page 31: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

TEGTEG- abnormal hemostasis and fibronolysis• Hepatic disease• Cardiac Surgery• ECMO• Assessment of bleeding peri-operatively and following trauma

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section

Page 32: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

• 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 & PathologyPoint of Care Testing (POCT) Section

TEG and NICE guidelines

Page 33: Safe Anticoagulation Management using Point of Care Dr. Tony Avades Sr. Consultant and Head of Chemistry, Endocrinology and POCT Sections DLMP Department.

THANK YOU

Department of Laboratory Medicine & PathologyPoint of Care Testing (POCT) Section