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Presentation to the Hospital Blood Bank Supervisors Association (Transfusion Medicine Auto-ID applications being developed) by Clive Hohberger, RFID Systems Architect, Blood Center of Wisconsin

Presentation to the Hospital Blood Bank Supervisors Association (Transfusion Medicine Auto-ID applications being developed) by Clive Hohberger, RFID Systems Architect, Blood Center of Wisconsin

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  • 1. RFID IN THE BLOOD SUPPLY CHAIN CLIVE HOHBERGER PHD MBA RFID SYSTEM ARCHITECT, BLOODCENTER OF WISCONSIN THE HOSPITAL BLOOD BANK SUPERVISORS ASSOCIATION 21ST SPRING SYMPOSIUM: 26 MARCH 2011•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 2. TRANSFUSION MEDICINE RFID CONSORTIUM•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 3. BACKGROUND AND MOTIVATION “Health care has to look at medical errors not as a special case of medicine, but rather as a special case of error …. And apply technologies and approaches used in other fields to reduce errors and improve patient outcomes.”•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 4. VISION AND PURPOSE • The use of RFID technology has the potential to advance both patient safety and operational efficiency and effectiveness. • To realize the benefits of RFID, there must be consistent standards for its use throughout the entire blood supply chain. • The technology must also be integrated with existing bar code labeling standards and blood and transfusion systems in use.•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 5. HOW RFID WORKS Use of radio signaling for automatic identification – Radio Frequency IDentification Tag RFID Reader Antenna Computer • An antenna/reader transmits an RF signal to the tag. • The batteryless RFID tag harvests the reader’s broadcasted RF energy to transmit a signal representing its data. • The antenna/reader receives the tag signal and decodes the data. • The reader formats the data and passes to a host system for processing. • The reader rapidly repeats the read at a quick and predefined interval.•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 6. RFID ADVANTAGES OVER BAR CODES • Ability to read, write and update information on wristband • Wristband can function as a “portable data base” • Ability to store and transfer more data • No line of sight required • Can read through clothing, bed clothes, wrist • Less need to disrupt patient to read wristband • Can be used to locate and track patients • Excellent environmental resistance when embedded • Patient can be bathed with it on • Resistant to body fluids, medication, food 13•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 7. GUIDING PRINCIPLES • Augment existing ISBT128 barcode based blood center operations and hospital transfusion systems, not replace them • RFID augments bar codes AND bar codes back up RFID tag • The RFID based system solution will NOT perform critical functions already performed by a Blood Enterprise Computing System (BECS); it complements the BECS. • Adhere to basic RFID Guideline recommendations from the ISBT RFID Working Party ( see: Vox Sanguinis, April 2010) • http://www3.interscience.wiley.com/journal/123338524/issue • Use of ISBT128 labeling, data structures and messaging • Tag will not substitute, replace, or contradict any required ISBT128 barcode or key labeling information • Include read verifications against the original bar code as validation•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 8. WHERE RFID WILL HELP IN BLOOD CENTERS Document Identify and Create RFID- Current Prioritize Enabled Processes “Pain Points” Processes Reconciling data • Build RFID unit / container relationships enabling with physical reality better tracking and faster reconciliation Physically locating • Use RFID to increase granularity of “last seen” products scan, increasing precision of known location Time out of • Provide alerts if the time between “last seen” in a temperature temp controlled locations is too long controlled locations Scanning multiple • Use RFID’s ability to read multiple units items simultaneously to drastically improve efficiency•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 9. Donor Sites Blood Center Hospital Point of Use Testing Transportation HospitalBlood Center RFIDprocesses alsosupport downstreamRFID processes in Inventorythe hospital Transportation Manufacturing•©TRANSFUSION MEDICINE RFID CONSORTIUM Shipping
  • 10. BLOOD CENTER PROCESSES Donation Site  Donation Site BDR BDR pouch Donation Site Pick - ups 1. Initialize New Blood Bag 2. Packing Containers Test tube set Blood bag container 3. Load and release a Pick-up Test tube container Blood bag set Work Station Collect Pack Load & Release Pick-up Blood Center • Blood Center Disposal Returns from Hospital Transfusion Services 1. Check-in Donations Quarantine 2. Label Product Find and Reconcile Work Station Find and Move 3. Check-in Inventory Donation Check-in Returns Shipments to Hospital 4. Verify Shipment Site Pick-ups Component Pending Available Pending Transfusion Services 5. Check-in Imports Inventory Mfg Inventory Shipment check -in Work Station Work Station Work Station Work Station 6. Check-in Returns Check-in Label Product Check-in Check in Imports Inventory Imports from other Donations Blood Centers Work Station•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 11. IMPACT ANALYSIS CONCLUSION – BLOOD CENTERS • It is technically feasible to implement 13.56 MHz (HF) RFID- enabled processes in the blood bank supply chain • Assessed economic justification for RFID enablement • Quality gains (eliminating discards and “lost products”) by better reconciliation and “last seen” guidance • Efficiency gains with reconciling and better data, less individual bag scanning • Cost of infrastructure and implementing new processes may be recovered by a blood center in 2-3 years • Assessed patient safety justification for RFID enablement • Safety justification for RFID enablement resides primarily in the hospital • Blood centers need to provide tracking capabilities that hospitals can leverage•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 12. WHERE WE ARE TODAY- BLOOD CENTERS • Completed FDA-required RF safety testing on blood products • Selected 13.56 MHz ISO 18000-3 mode 1 tags and readers • Implementing and extending ISBT RFID Guidelines • Conducting additional performance and survivability testing with the tags and equipment selected • S3edge has developed RFID middleware based on Microsoft BizTalk RFID and completed two rounds of blood center applications software testing • Pilot installation and testing at BloodCenter of Wisconsin begins in 3Q11•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 13. TECHNOLOGY SELECTION•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 14. BUILDING UPON THE ISBT RFID GUIDELINES • Principles of the Guidelines have been implemented by the RFID Consortium • Guidelines build on ISBT128 bar code labeling standard • Members of the RFID consortium participated in their development • In doing an actual implementation of RFID, many new things have been learned which have allowed the consortium to evolve the guidelines•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 15. TAG AND DATA STRUCTURE ASSUMPTIONS • A fundamental assumption underlying ISBT128 is that the blood product label should carry all the key data about the product • Database access may not be available at a disaster or battlefield site where transfusion occurs (ex: Haiti ) • RFID tags enable additional information about the product to be stored • 13.56 MHz ISO 18000-3 mode 1 tags will be used • Conform to ISBT Guidelines • Global frequency standard; tags and readers widely supported • Tags on blood bags must survive • Centrifugation • Blast freezing of plasma and dry ice contact • Gamma irradiation•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 16. PHYSICALLY TAGGING BLOOD PRODUCTS • Existing preprinted ISBT128 Donation Number (DIN) bar code label sets will continue to be used for now • At Donation Site, apply 14x31 mm RFID tag under DIN label • On RBC product bag for whole blood collection in a 3-bag collection set • Manufactured blood products (ex: plasma) get a blank RFID tag applied and programmed during final product labeling • In the future, tags may be pre-applied and pre-encoded by the bag manufacturers•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 17. TAG TESTING CONDITIONS • Each tag was attached to a simulated blood bag • Testing was also done in three different containers • Cooler (≤ 17 bags) • Packed with ice • Styrofoam box (≤ 30 bags) – Packed with ice, dry ice or warmer gel packs • Refrigerator tray (≤ 12)•©TRANSFUSION MEDICINE RFID CONSORTIUM 17
  • 18. TUNNEL AND PAD ANTENNA READERS • Tunnel readers used at check in and outbound shipment to read Coleman and box coolers and platelet warmer boxes without opening • Pad reader antenna used during final labeling, tray reading and by hospital•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 19. UNITECH PA600 MOBILE CLINICAL ASSISTANT • Primary reader used at donation site and at transfusion sites • Bar code laser scanner • 13.56 MHz RFID reader • 802.11g wireless LAN • Dual thumb triggers • Li-ion rechargeable battery•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 20. RFID TAG MEMORY STRUCTURE ASSUMPTIONS • Only ISBT128 compliant data structures are used in tag memory • Designed for Code 128 bar codes, but are data carrier independent • Uses 7-bit ISO 646 (ASCII) characters • Additional ISBT128 data structures will be designed for RFID features not supported in ISBT128 barcodes•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 21. RFID TAG DATA HANDLING AT THE BLOOD CENTER Data written to the fixed user memory of the RFID tag during blood center processing Component Blood Component Final Remanufacturing: Donation Manufacturing: Labeling Redefine Product Define Product Product ID, ISBT 128 Procedure Expiration Date Step Time ABO/Rh Donation ID Type, Date and Expiration Time Stamp Stamp Times Write Once Write Once Re-Writable Write Once & Lock & Lock Re-Writable & Lock & Lock At Critical Process Steps•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 22. RFID TAG DATA HANDLING AT THE HOSPITAL Data written to the fixed user memory area of the RFID tag during transfusion services processes: Issue and Return Product Component Release for to Blood Modification Transfusion Center (1) Product ID, Patient ID Patient Expiration Date Step Stamp Time Stamp Number DOB Expiration Time Re-Writable Re-Writable Re-Writable Re-Writable At Critical (1) MUST clear Patient ID Number & DOB data blocks Process Steps•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 23. SAFETY OF HF RFID WITH BLOOD PRODUCTS•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 24. MANDATE FROM FDA TO CONSORTIUM: “You can do all the testing you want with RFID tags on blood bags, but you can’t transfuse a single unit of that blood until you prove that exposure to the RFID reader radiation hasn’t compromised the safety or efficacy of that blood product” Dr. Jay Epstein, Director Office of Blood Research & Review FDA CBER March 15, 2007•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 25. “LIMIT TEST” CONCEPT • Expose a small group of blood components to higher RF power levels and longer times that ever would be seen in practice • Assay blood samples at 7h and 24h for thermal and biochemical changes • Compare exposed product with unexposed control group Parameter Real-Life Limit Test RF exposure time <20 m over lifetime 23-25 hours with 1h break RF magnetic ~1 Amp/meter 5 Amps/meter field strength Relative total RF =1x 330-360x exposure, in Joules•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 26. 2007 & 2010 LIMIT TEST RESULTS • 2007 tests: Red blood cell (RBC) and platelet products did had no increased cellular/protein degradation after high levels of extended exposure to RF • Joule heating by the RF field had acceptable effects on the temperature rise of RBC and platelet products • Davis, Rodeina, J Gottschall, A Gutierrez, C Hohberger, D Veeramani and J Holcombe. Transfusion 2010;50:1596-1603. • Results led to approval by FDA on April 21, 2008 to go-ahead to prototype and pilot HF RFID with RBCs and platelets • FDA also requested additional tests on plasma and aged RBCs (near 42 days). These tests were run in early 2010; results under evaluation by FDA • RBC results consistent with prior tests • Plasma temperature rise due to Joule heating was acceptable with no impact on coagulation factors•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 27. HOSPITAL RFID SOLUTION•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 28. TRANSFUSION SERVICES RFID-ENABLED TOUCH POINTS Begin Transfusion End Transfusion Hospital Blood Bank Point of care match Returns To Blood Center Return Pending return to blood RFID Work Station center Reclaim Pad reader Patient Pad reader Disposal Shipments from Blood Center Pending RFID Work Station Available check-in Storage movement RFID Work Station BECS Work Release Station to floor Pad reader Issued and Receive Pending RFID Work Station BECS Labeling Release Station Pad reader Label Dispense Check-in Location Check-out Location•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 29. HOSPITAL TRANSFUSION PROCESSES  Transfusion Services Use Case Scenarios 1. Receive a shipment from the blood center 2. Label a blood bag (required to update the RFID tag information) 3. Release a blood bag to the hospital floor 4. Reclaim a blood bag from the hospital floor 5. Dispose of a blood bag (required to clear HIPAA data from the tag) 6. Pack and ship a return shipment to the blood center  Hospital Floor Use Case Scenarios 1. Sample collection – match sample tube ID with patient ID 2. Transfuse begin and complete the transfusion of a blood bag 3. Track location and movement – of blood bags in hospital storage locations•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 30. HOSPITAL PAIN POINTS SUMMARY Document Identify and Create Current Prioritize RFID-Enabled Processes “Pain Points” Processes Pain Point Benefit of an RFID Enabled Solution 1) Identifying correct Patient Alert care giver if identifiers don’t match Can use RFID enabled wristbands 2) Identifying collection tube Ensure proper labeling is performed in a timely basis 3) Ensure correct matching of key Automate checking /confirmation of step completion process elements (tube, TRF,…) 4) Ensuring compatibility tests results Automate checking /confirmation of step completion are checked 5) Tracking time and temperature Increased granularity of “last seen” scan, thereby increasing accuracy of metric tracking (time out of cooler, etc.)•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 31. HOSPITAL TRANSFUSION SERVICES - IT NETWORK Hospital BECS Spotlight Server At Bedside In Blood Bank WLAN RFID/bar Hospital LAN code readers w Spotlight Mobile Bluetooth paddle USB barcode RFID reader readers Fixed RFID PAD Readers•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 32. POINT OF CARE: RFID-AUGMENTED 3-WAY MATCH Step 1: RN obtains and carries Step 2: RN launches the “Begin Step 3: When transfusion Step 4: RN disposes of the following into the patient’s Transfusion” application: completes, an RN starts the transfusion material as room. “Complete Transfusion” appropriate. 1) Scan RN ID badge** application: · RN ID tag** 2) Scan patient wrist band · Blood Bag 3) Scan blood bag 1) Scan ID badge** · Handheld bar code/ 4) Validate match with the BECS 2) Scan patient wrist band RFID reader 5) If transfusion is OK to proceed – 3) Confirm transfusion completion RN select “Transfuse” & starts the and enters results (OK, transfusion*** aborted, etc.) 6) If transfusion is delayed - 4) Scans blood bag tag select “Delayed” and return the (deletes HIPAA data from tag) blood bag to the blood bank 5) Selects OK Patient Patient Disposal ** ID tag RFID scan can be replaced with a handheld login or bar code scan of ID tag. *** Time out of temperature controlled environment can be checked and an alert signaled hered.•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 33. TRANSFUSION DISPENSE, CONFIRMATION AND START • Airport-style display in the blood bank displays all blood products currently “Issued” • A fixed RFID reader scans each blood bag as it exits the blood bank (e.g., is sent in the pneumatic tube) - the transfusions status is updated to “Dispensed” • The transfusion nurse uses a handheld reader to begin the transfusion– (scanner displays shown) • Scans the patient wrist band • Scans the blood bag • Confirms the match and selects “start” – the transfusion status is updated to “Started”•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 34. SCAN BARCODE OR RFID WRIST BAND FOR ID•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 35. RECORD PATIENT ID FOR 3 WAY MATCH•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 36. SCAN UNIT TO VERIFY MATCHES ORDER AND ID•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 37. TELL IT SYSTEM THAT TRANSFUSION IS IN PROCESS•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 38. HANDHELD CAN COLLECT VITAL SIGNS FOR RECORD•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 39. TRANSFUSION COMPLETION AND CLOSE-OUT • The transfusion nurse uses a handheld reader to complete the transfusion • Scans the patient wrist band • Enters the transfusion results • Scans the blood bag to complete the transfusion – the transfusion status is updated to “Complete” • Scanner deletes all HIPAA info from the RFID tag on bag•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 40. SUMMARY OF HOSPITAL BENEFITS • Transfusion Safety (Reducing/eliminating errors) • Automate issue and release of blood • Record / monitor chain of custody•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 41. PATIENT SAFETY ROI MODEL: ERRORS EFFECTS Transfusion processes errors Identification / location related errors Adverse Reactions Patient effects Overall Mortality Index Overall Morbidity Index Before After Before After Gain % Gain %•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 42. IMPACT ANALYSIS CONCLUSIONS – HOSPITALS • Economic justification for RFID enablement • It is economically justifiable to invest in RFID infrastructure and implementing new processes as cost may be recovered by a large hospital in 2-3 years. • Patient Safety justification for RFID enablement • Patient safety model analysis provides promise that mortality rates could be improved by use of RFID • Morbidity effects will be studied next•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 43. KEY CHALLENGES • No universal hospital transfusion process • Information systems integration • Integration with other concurrent care processes • Safety gains – • Difficult to track/ confirm • Biovigilance system development and adoption • Fear of the unknown/ invisible • Nursing compliance•©TRANSFUSION MEDICINE RFID CONSORTIUM 4
  • 44. WHERE WE ARE TODAY – HOSPITAL SOLUTION • Process review and reengineering performed with two participating hospitals • Solution functional specifications completed – in final validation • S3edge is developing SpotLight RFID middleware based on Microsoft BizTalk RFID • Will perform first round of hospital applications software testing in 3Q11•©TRANSFUSION MEDICINE RFID CONSORTIUM
  • 45. FOR FURTHER INFORMATION AND UPDATES www.transfusionmedicineRFID.org•©TRANSFUSION MEDICINE RFID CONSORTIUM