Auto-ID in the Blood Supply Chain

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

TRANSFUSION MEDICINE RFID CONSORTIUM


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.”


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.


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.


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

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


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


Donor Sites Blood Center Hospital

Point of Use
Testing

Transportation

Hospital

Blood Center RFID
processes also
support downstream
RFID processes in Inventory
the hospital
Transportation
Manufacturing

Shipping

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


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


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


TECHNOLOGY SELECTION


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


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


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


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

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


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


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


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


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


SAFETY OF HF RFID WITH BLOOD
PRODUCTS


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


“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


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


HOSPITAL RFID SOLUTION


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


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


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.)


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


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 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”


SCAN BARCODE OR RFID WRIST BAND FOR ID


RECORD PATIENT ID FOR 3 WAY MATCH


SCAN UNIT TO VERIFY MATCHES ORDER AND ID


TELL IT SYSTEM THAT TRANSFUSION IS IN PROCESS


HANDHELD CAN COLLECT VITAL SIGNS FOR RECORD


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


SUMMARY OF HOSPITAL BENEFITS

• Transfusion Safety (Reducing/eliminating errors)
• Automate issue and release of blood
• Record / monitor chain of custody


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 %

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


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

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


FOR FURTHER INFORMATION AND UPDATES
www.transfusionmedicineRFID.org


Auto-ID in the Blood Supply Chain

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