11073-10418 INR

1. 11073-10418 INR Purpose • Monitor the coagulation of blood for those on anti-coagulation therapy • Monitor for therapeutic levels of medication • Monitor for safe levels of therapy • Advise on adjustment to therapy • Titrate to therapeutic level Approach • Coagulability measured from sample of arterial or venous blood using thromboplastin to determine prothrombin time (PT) • Different thromboplastins available and will give different results INR - International Normalized Ratio • Determines coagulation time compared to normalized reference • Allows values from different thromboplastins to be compared • Given as a simple number

2. Use Cases Health care professional testing and therapy management • Regular measurement to maintain therapeutic level by a health care professional • Management by the health care professional Self testing • Regular measurement to maintain therapeutic level by the patient • Measurements sent to health care professional for advice • Warnings if out of therapeutic range or if severely out of range Self management • Regular measurement to maintain therapeutic level by the patient • Patient advised how to self manage • Device may have target level, information on drug and dose and intelligence to advise on medication change

3. Use Cases Patient Care Pathway • Patient is under medical care of primary “physician” (will vary by country and system) who has responsibility for regime • Measurements reviewed and advice may be given to alter medication • Warnings if out of therapeutic range and medical intervention required • Warnings if severely out of range

4. Data Requirements(this defines the data that the INR must provide in some way) • INR - required • Date and time stamp - required • Target therapeutic range – required • INR value out of therapeutic range – required • INR value at dangerous clinical level – required • INR value out of clinical range – required • Status of measurement – required • Batch/code number – required • Device alarm conditions - required • Serial # - required • Prothrombin Time (PT) - supplemental • Quick Value – supplemental • International Sensitivity Index (ISI) – supplemental • Medication – supplemental • Review period - supplemental • Recommended new level of medication – supplemental • Device type / model - supplemental • Manufacturer - supplemental • User Identifier – supplemental • Additional information - supplemental

5. Data Objects(defines the objects needed to satisfy the data requirements) • INR – required • Target therapeutic range – required • INR value out of therapeutic range – required • INR value at dangerous clinical level – required • INR value out of clinical range – required • Batch/code number – required • Status of measurement - required • Device alarm conditions – required • Prothrombin Time (PT) - supplemental • Quick Value – supplemental • International Sensitivity Index (ISI) – supplemental • Medication – supplemental • Review period - supplemental • Recommended new level of medication – supplemental • Additional information - supplemental

6. Data Attributes(specifies data that already is defined as an attribute or otherwise) • Date and time stamp – required • Serial # - required • Device type / model - supplemental • Manufacturer - supplemental • User Identifier – supplemental • Following may be included in Status of Measurement • INR value out of therapeutic range – required* • INR value at dangerous clinical level – required* • INR value out of clinical range – required*

7. Data Objects(defines the objects needed to satisfy the data requirementsgrouped and ordered logically) • Clinical Data • ProthrombinTime (PT) - supplemental • Quick Value – supplemental • INR – required • Batch/code number – required • International Sensitivity Index (ISI) – supplemental • Status of measurement – required* • Monitoring • Target therapeutic range – required • Management • Medication – supplemental • Review period - supplemental • Recommended new level of medication – supplemental • Additional information – supplemental • Device • Device alarm conditions – required

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18. References References • Lutze G. Useful facts about coagulation. Mannheim: Roche Diagnostics GmbH, 2000. (data on file) • Wagner C, Dati F. Thromboplastinzeit (german article). In: Thomas L, ed. Labor und Diagnose: TH-Books Verlagsgesellschaft, 2000; 613-616. • Kovaks MJ et al. Thromb Haemost 1994; 71: 727-730.

19. Domain Information Model