ISBT 128 Time to Go Live

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ISBT 128 Time to Go Live!

• Debra Bowman, MT(ASCP)SBB
• Executive Director of Quality Regulatory
  Affairs
• Kentucky Blood Center

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It Is Finally Happening

• After much talk, lots of planning, and an
  enormous amount of hard work, KBC will go live
  with ISBT 128 on December 6, 2009!

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How Long Have We Talked About This?

• FOR YEARS!!!
• 1997 AABB hosted workshop to discuss
  implementation.
• AABB published standard requiring implementation,
  then rescinded.
• 25th Edition of standards required implementation
  by May 2008 or apply for variance

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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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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.
• Designed to capture additional and more complex
  information than Codabar.

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What Is It All About?

• Standardizes labeling of blood components
  worldwide.
• 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.
• Todays world is one where there is increased
  globalization and it is more common to share
  blood products 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.
• Mis-scans are extremely rare.
• Provides uniform label format data can be read
  worldwide no matter what the language.

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Advantages

• Provides unique DIN (Donation Identification
  Number) world wide with no repeat for 100 years.
• Allows for expanded description of product
  codes and future expansion.
• Captures special test information.
• Enhanced traceability features.

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Advantages

• Can be used with RFID 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 codes 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 Standards established a May 1, 2008
  implementation deadline for accredited blood
  centers and hospital transfusion services. They
  did allow for variances. New standards do not
  allow for variances.

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So What Can You Expect?
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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 2009.
• Labels will all be black and white. No color.
• No collection date.

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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 identifiers ensure data cannot be entered
  into the wrong field.

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Data Identifiers

• Allows data to be entered into the correct field
  no matter the order in which 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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Eye Readable Product Names

• Class General Description Whole Blood, Red
  Cells, Fresh Frozen Plasma, etc
• Modifier Description that distinguishes from
  others in class Apheresis, leukocyte reduced,
  deglycerolized, etc
• Attributes Core conditions Anticoagulant,
  volume, storage requirements, etc

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Example of Use With Patient Identification
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What can you expect when KBC goes live?
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KBC - DIN

• KBCs Facility ID is 0382 so all DINs will start
  with W0382
• Will use 2010 when we start on 12/6/09. Can use a
  given year for one month before and after.
• Ex. W038210XXXXXX

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Donation Types

• KBC product codes will use the following
  designations for donation type
• V for volunteer
• 1 for autologous non-biohazard
• X for autologous biohazard

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Autologous Donations

• ABO/RH smaller and have different eye-readable
  and machine-readable codes than those for
  homologous donors.
• Intended recipient information prints and is
  placed above face label.

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Designated Donations

• All are eligible for crossover, so will use
  volunteer donation type.
• Intended recipient information on tag as we
  currently do.

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Split Units

• Will no longer have As, Bs, or Cs added to
  unit number.
• Product code shows that unit is split A0, B0
  and C0.
• If split is further divided, would indicate as
  Aa, Ab, etc

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Apheresis Red Cells and Platelets

• If collected as a double or triple, will have
  eye-readable information at bottom of face label
  that says 1st container, 2nd container, etc
• Will have product code specific for 1st
  container, 2nd container, etc

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Fresh Frozen Plasma

• Will be labeled with codes that correspond to
  volume.
• Pricing will be by volume.
• Many will be splits with A0, B0, etc

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CMV

• Will no longer have a separate CMV negative
  sticker.
• CMV negative will be specified in lower right
  quadrant as special testing.

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Imports

• Imports will no longer be relabeled with a KBC
  unit number (DIN) since all DINs are unique.
• Exception will be if we import a Codabar labeled
  unit, which will be relabeled with a KBC Codabar.
  Do not anticipate this happening.

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Mixed Inventory

• Will have mixed inventory until all Codabar units
  are used.
• 5 days for platelets
• 42 days for red cells
• 1 year for frozen plasma products
• 10 years for frozen red cells
• Modified Codabar-labeled products will be
  relabeled in Codabar

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Preparation for 12/6/09

• Will need to take computer down for most of the
  day to install new programs.
• Will not collect products that day.
• Will make inventory adjustments to make up for
  not collecting on that day.
• Will stock hospitals as flush as possible on 12/5
  to minimize manual shipping on 12/6.

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Hospital Readiness Checks

• Hopefully, your facility has already used the
  information that has been previously provided and
  is prepared for this change.
• The following slides are reminders of things to
  consider in your readiness check.

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Hospital Readiness Checks

• If you have a blood bank computer, have you
  validated that the system is ISBT 128 ready and
  performs as expected? Do your scanners read ISBT
  128 and Codabar?
• If you do not have a computer, have you evaluated
  all your forms to ensure that 13 digit DIN and
  longer product codes and descriptions can be
  accommodated?

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Hospital Readiness Checks

• Have you reviewed your SOPs and forms to
  determine which ones need to be revised? Are they
  revised?
• Have you evaluated training needs and prepared
  the necessary training plans? Dont forget that
  in addition to blood bank staff, nursing and OR
  staff need to be trained as well. Also consider
  if accounting staff need to be trained.

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Hospital Readiness Checks

• If your facility modifies, pools, splits or
  aliquots units have you
• Registered with ICCBA?
• Ordered appropriate preprinted labels or
• Validated your software and printer will print
  appropriate labels?

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Other Things to Consider

• Billing systems will need to accommodate the
  ISBT 128 data structure and the new 13 digit
  DINs.
• You will need to maintain ability to read both
  ISBT 128 and Codabar for the length of time that
  Codabar products may be received.

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Other Things to Consider

• The expiration date on units may be obscured by
  the cups used to hold units which could
  interfere with good inventory management.
• Little unexpected things will crop up, requiring
  patience and perseverance!

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For Help

• Visit hospital section on KBCs website to view
  materials.
• Contact
• Lisa Honaker [phone] for IT help
• Shelley Vish [phone] for billing help
• Debbie Bowman [phone] for general
  questions

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Summary

• It is finally happening!
• There are a lot of resources to help you make the
  transition.
• CHANGE IS GOOD!!!!!!!!!!!