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 requirements grouped and ordered logically) Clinical Data Prothrombin Time (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

8. Data Objects

18. References 1.Lutze G. Useful facts about coagulation. Mannheim: Roche Diagnostics GmbH, 2000. (data on file) 2.Wagner C, Dati F. Thromboplastinzeit (german article). In: Thomas L, ed. Labor und Diagnose: TH-Books Verlagsgesellschaft, 2000; 613-616. 1.Kovaks MJ et al. Thromb Haemost 1994; 71: 727-730.

19. Domain Information Model