Transcript ISBT-128: It’s Finally Happening!

ISBT-128: It’s Finally Happening!
KABB Spring Meeting
March 10, 2007
Debra Bowman, MT(ASCP)SBB
Quality Assurance Director
Kentucky Blood Center
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What Is It All About?
The International Society for Blood
Transfusion (ISBT) has developed a
replacement for the ABC Codabar
symbology which is currently used to label
blood components.
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How Long Have We Been
Talking About This?
FOR YEARS!!!!!!
In 1997 AABB hosted a workshop to discuss
implementation issues.
AABB had standard requiring implementation
that was later rescinded.
Now AABB requires implementation by May
1, 2008
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What Is It All About?
ISBT 128 is a uniform labeling standard for
blood components designed to capture
information regarding identification and
content of blood and blood products and to
make that information universally
accessible to the international blood
banking community.
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What Is It All About?
The new ISBT 128 bar code symbology
was designed to capture additional and
more complex information within the bar
code.
The technology was developed through
international consensus and allows for
world wide standardization of information
for labeling and data exchange .
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What Is It All About?
It is an internationally agreed upon
information technology standard that
includes specifications for labeling of blood
components and for data transfer.
ISBT 128 will be maintained through the
International Council for Commonality in
Blood Bank Automation (ICCBBA).
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Why?
The current Codabar technology has
reached its limit of usefulness in a world of
increasingly complex information
technology.
Today’s world is one where there is
increased globalization.
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Why?
It is common for blood centers to sell
products in the global market.
During times of disaster, blood products
may be shared around the world.
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What Are the Advantages?
Allows for more complex information to be
encoded.
Is more secure because it has 3 self
checking features per character.
Misscans are extremely rare.
Provides uniform label format.
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Advantages
Provides unique donation ID number world
wide. (DIN- Donation Identification
Number)
Allows for expanded description of product
codes and future expansion.
Captures special test information.
Enhanced tracability features.
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Advantages
Can be used with RIF technology.
Double density coding.
No hand written data on labels.
Decreased inventory of pre-printed labels.
Decreased label stress testing.
More efficient label inventory management.
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ISBT 128 Standard
Provides standard layout of blood
product label.
Defines data identifiers for the bar
code used in blood, tissue, stem cell
labeling and data transfer.
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ISBT 128 Standard
Defines data structures that carry
information.
Defines technical details for the bar
code.
Defines concatenation principles.
Includes tables of definitions.
Identifies ICCBBA as the authority.
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US Authorities
FDA approved and provided guidance
in the U.S. Industry Consensus
Standard for the Uniform Labeling of
Blood and Blood Components Using
ISBT 128 Version 2.0.0, published in
the Federal Register in November
2005.
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US Authorities
21 CFR 610.121 (c) 13 took effect on
April 26, 2005 and requires blood
banks to have certain information in
machine readable format on the labels,
including facility identifier, donor ID,
product code, and ABO/Rh of the
donor.
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US Authorities
AABB in the Association Bulletin #0512 established a May 1, 2008
implementation deadline for accredited
blood centers and hospital transfusion
services.
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Visual Differences
Donation Identification Number (DIN) will
be longer – 13 characters.
Product codes will be different and will
include donation types and splits.
Printed product description will be different.
Expiration date will be in different location
and will be eye-readable as 15 NOV 2006.
Labels will all be black and white. No color.
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Data Identifiers
Data identifiers allow software to
identify the contents of the data stream
and validate that it belongs in the field
intended.
Data cannot be entered into the wrong
field.
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Data Identifiers
Allow data to be entered into the
correct field no matter what order it is
entered.
Allows data to be concatenated which
means that two related bar codes are
read at one time.
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Check Digits
Uses Check digits on number series
Donor Identification Number (DIN)
Patient medical record numbers
1234567 9 where 9 is calculated from the
other numbers in the set.
Get error message for invalid entry.
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Credit
These next slides are
from the November
15, 2006 AABB
Audioconference
because “it doesn’t get
any better than
this!” >>>>>>>>>>
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Example of Use With
Patient Identification
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How Do Hospitals Get
Ready?
Check with your blood supplier to see
when their implementation date is.
Most blood centers will work with hospital
customers to help them prepare.
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How Do Hospitals Get
Ready?
Gather educational resources.
FDA Guidance at
http://www.fda.gov/cber/gdlns/ISBT12
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ISBT Code 128 Implementation Plan
at aabb.org
General information, technical
information, registration information,
registered vendor list at ICCBBA.org 59
How Do Hospitals Get
Ready?
Register with ICCBBA if your
transfusion service is going to modify
products and apply ISBT 128 labels.
Note: Registration costs $200 initially
and
$100 annually if you do not
collect products.
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How Do Hospitals Get
Ready?
Check with your computer software vendor
to make sure your software is ISBT 129
compatible.
Check your scanners to make sure they can
read ISBT 128 labels.
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How Do Hospitals Get
Ready?
Check your printers to make sure they can
print ISBT 128 labels if you are going to
modify products. (Will need to be 300 dpi.)
Determine what labels you will need to
print. Ex. Labels for pooling, leukoreducing
or splitting products.
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How Do Hospitals Get
Ready?
Form an implementation team.
Create an implementation plan, using the
aabb plan as a guide.
Budget for and purchase any software or
hardware that you do not currently have.
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How Do Hospitals Get
Ready?
Determine what forms will need to be
revised.
Determine which SOP’s will need to be
revised.
Determine what training will need to
be done.
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How Do Hospitals Get
Ready?
Determine what label supplies will
need to be purchased.
Review your processes and determine
how they will change.
Include such departments as nursing,
OR, ER, and accounting in your
planning.
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How Do Hospitals Get
Ready?
Plan how to handle units during
transition.
Write validation plans for your
hardware, software, labels, processes,
SOP’s and training plans.
Execute your validation.
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Things to Consider
Hospital billing systems will need to
accommodate the ISBT 128 data
structure and the new 13 digit DIN’s.
Any manual forms will need to be
updated to allow for longer unit
numbers and product codes.
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Things to Consider
During transition you will need a way
to handle both ISBT 128 and Codabar
to account for frozen product that are
still in inventory and labeled with
Codabar.
New expiration date location may be
obscured by blood bag cup holders.
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Things to Consider
A blood center that has already
implemented reported that their
hospitals reported an average of:
45 hours planning and implementing.
$1000 for scanners
$300 for license fees
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Summary
It is finally happening!
There are a lot of resources to help you
make the transition.
CHANGE IS GOOD!!!!!!!!!!!
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