1. caTrack: efficient, quality data capture for caTissue. Mahesh Nalkande, Sameer Pendharkar, Preeti Lodha, Abhijeet Kashnia, Taru Jain, Rachita Yadav, Sarita Tony, Fernanda Rankin, Amber McMahon, Dr. Susanne Ragg, Dr. Gunther Schadow Regenstrief Institute PERSISTENT

2. Agenda Sample use cases involving data entry Problem Definition Solution caTrack workflows caTrack Demo Technical insight Future enhancements

3. Sample use cases involving data entry

4. Use case 1 : Assigning position to container 1 2 3 4

5. Use case 2 : Participant Registration 1

6. Use case 3 : Specimen collection storage location assignment 1 2 3

7. 4

8. Use case 4 : Adding events to specimens 1 2 4 3

9. Problem Definition Problems or anticipated problems with these workflows: 1.Much clicking and typing involved. 2.Keeping event time is inexact, scribble on paper. 3.Risk of data entry errors. 4.Average time spent per operation is 2-3 minutes.

10. How does caTrack solve these problems? caTrack - barcode based PDA application Automatic Data Capture (ADC) Log collection and processing steps as you go Off-line operation, independent of WiFi Network When done, populates with caTissue repository Minimizes data entry efforts Keeps accurate time of all events Enables specimen quality tracking

11. How does caTrack fit in tissue banking system? Scan Participant Barcode Scan Storage container / specimen barcode Scan Centrifuge barcode. Storage location Grid map. Lab Technician caTrack caTissue Application BioSpecimen Database caTrack Business Logic PDA with Scanner Web Service

12. A complete workflow… Sticks SCG label to the Specimen Collection Form Sticks specimen label to a blank specimen vial Lab Technician Collection Kit -> Specimen Collection form + Labeled vial + second SCG label to be pasted on the Consent form + second identical specimen label Clinical Research Coordinator Sticks the second SCG label on the Consent Form Surgeon Takes the Collection Kit Collects specimen into the vial Fills in details on the Specimen Collection Form Puts the vial inside a mini-cooler Logs in to caTrack application, by scanning his user badge or tapping on ‘UserContext’ 1 2 8 3 74 65

13. caTrack usecases Current scope of caTrack:  Set the collected and received events of a specimen on first scan.  Assign a storage location to specimens.  Transfer specimens or containers within containers.  Add frozen, centrifuge events on specimens.

14. caTrack workflow Initialization Login : Scan User Batch Scan centrifuge Scan Specimens Scan containerScan Specimens/containers

15. Demo

16. Initial Application Screen The caTrack application has been started. The initial screen is blank. The connectivity icon tells whether it is connected to server or not.

17. Scanning A User Scanning a User barcode. Or press the user context button.

18. Scanning a box Scan the barcode on the Storage container

19. Scanning the Specimen vial Scan the barcode on the specimen vial, which is received by the Biobank.

20. Map View By default highest empty location within container is assigned. Map view to change the location of specimen vial within the storage container.

21. Uploaded Data in caTissue

22. Finite State Machine (FSM) caTrack design is based on a FSM State machine encodes the workflows – configurable through xml file Example for simple workflow: User Box Initial User/ scUser Reset / Reset Box/scBox User/User Reset Reset/Reset Vial/Error Unkn own/erEvent Box / scBox Vial / maBox:vial Unknown / erEvent

23. How caTrack works? Read configuration items, finite state machine and storage container information from XML file. Accept input from barcode scanner. Check for next state and action to be taken using finite state machine. Display message to user and change the state Entry point Download Storage container information Upload the storage container information caTrack Web Service caTissue Suite HTTP Service caTissue Database caTrack PDA Application

24. Future Enhancements Check if specimen is placed in correct box – obey restrictions on container Better display of specimen label on PDA screen On scan of patient label, query hospital system for participant information Add additional specimen events, e.g. Review Retrieval, shipping and tracking – Loading a shipping container is supported today – Display “shopping list” for efficient retrieval Support multiple PDA within same site Site-specific configuration in multi-site setting

25. Deployment Requirements caTrack is freely available under LGPL license Software requirements – caTissue – ActiveSync –.NET Compact Framework Hardware Requirements – PDA with Windows Mobile 5.0 – Barcode scanner

26. Conclusion caTrack adds to efficient high-throughput biospecimen banking by – Eliminating time consuming data entry steps – Capturing accurate specimen quality detail – Decreasing the error rate

27. Acknowledgements Dr. Gunther Schadow Dr. Susanne Ragg Sarita Tony Fernanda Rankin Amber McMahon Sharmila Jothirajah Persistent Systems Ltd Preeti Lodha Sameer Pendharkar Abhijeet Kashnia Taru Jain Rachita Yadav Madhurima B. Abhijit Naik Sarfraz Shaikh Sonal Shah Komal Gulati Indiana University

28. Questions?? mahesh_nalkande@persistent.co.in gschadow@regenstrief.org