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ISBT 128 Time to Go Live

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Allows for expanded description of product codes and future expansion. ... Billing systems will need to accommodate the ISBT 128 data structure and the new ... – PowerPoint PPT presentation

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Title: ISBT 128 Time to Go Live


1
ISBT 128 Time to Go Live!
  • Debra Bowman, MT(ASCP)SBB
  • Executive Director of Quality Regulatory
    Affairs
  • Kentucky Blood Center

2
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!

3
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    then rescinded.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

4
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.

5
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.

6
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).

7
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.

8
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.

9
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.

10
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.

11
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.

12
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.

13
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.

14
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.

15
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.

19
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.

20
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.

21
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
51
What can you expect when KBC goes live?
52
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

53
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

54
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.

55
Designated Donations
  • All are eligible for crossover, so will use
    volunteer donation type.
  • Intended recipient information on tag as we
    currently do.

56
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

57
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

58
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

59
CMV
  • Will no longer have a separate CMV negative
    sticker.
  • CMV negative will be specified in lower right
    quadrant as special testing.

60
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.

61
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

62
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.

63
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.

64
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?

65
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.

66
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?

67
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.

68
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!

69
For Help
  • Visit hospital section on KBCs website to view
    materials.
  • Contact
  • Lisa Honaker (859) 519-3737 for IT help
  • Shelley Vish (859) 519-3702 for billing help
  • Debbie Bowman (859) 519-3717 for general
    questions

70
Summary
  • It is finally happening!
  • There are a lot of resources to help you make the
    transition.
  • CHANGE IS GOOD!!!!!!!!!!!
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