Kathy Brient, MT(ASCP)SBB Laboratory Information … · ISBT 128-A Hospital Blood Center...

ISBT 128-A Hospital Blood Center Perspective

Kathy Kathy BrientBrient, MT(ASCP)SBB, MT(ASCP)SBBLaboratory Information System Laboratory Information System ManagerManagerSt. LukeSt. Luke’’s Episcopal Health Systems Episcopal Health Systemkbrientkbrient@@slehsleh.com.com

Hospital Blood Center Perspective

St. LukeSt. Luke’’s Episcopal Hospital is a 950 s Episcopal Hospital is a 950 bed tertiary care hospital in the Texas bed tertiary care hospital in the Texas Medical Center in Houston.Medical Center in Houston.Home of the Texas Heart Institute Home of the Texas Heart Institute Primary teaching hospital for Baylor Primary teaching hospital for Baylor College of Medicine.College of Medicine.Emphasis on Cardiovascular Care Emphasis on Cardiovascular Care

ISBT 128 Implementation

SLEH Blood Center collects and labels 60,000 SLEH Blood Center collects and labels 60,000 ISBT blood products annually.ISBT blood products annually.SLEH Transfusion Service transfuses 75,000 SLEH Transfusion Service transfuses 75,000 blood products annually.blood products annually.SLEH was uniquely positioned to implement SLEH was uniquely positioned to implement ISBT because all of our blood products are ISBT because all of our blood products are used internally.used internally.

We are not FDA licensed to ship out of state.We are not FDA licensed to ship out of state.

All of our donor testing is done by the Gulf All of our donor testing is done by the Gulf Coast Regional Blood Center.Coast Regional Blood Center.

ISBT 128 Implementation

With installation of our With installation of our Wyndgate SafetraceWyndgate SafetraceDonor system in 2002 we converted to ISBT Donor system in 2002 we converted to ISBT labeling on all of the products we produce.labeling on all of the products we produce.With installation of our With installation of our Safetrace Safetrace TX system TX system in July 2004 we converted to ISBT labeling in July 2004 we converted to ISBT labeling for all modified ISBT products for transfusion.for all modified ISBT products for transfusion.July 2004July 2004-- First veinFirst vein--toto--vein ISBT 128 vein ISBT 128 products were issued with electronic products were issued with electronic crossmatchcrossmatch..

21 CFR 606.121 c (13)FDA Final Ruling

Effective April 26, 2006, each label must have Effective April 26, 2006, each label must have machinemachine--readable information that contains, readable information that contains, at a minimum:at a minimum:

(A) A unique facility identifier;(A) A unique facility identifier;(B) Lot number relating to the donor;(B) Lot number relating to the donor;(C) Product code; and(C) Product code; and(D) ABO and(D) ABO and RhRh of the donor.of the donor.

Expiration Date/time barcode is not required Expiration Date/time barcode is not required but may be necessary for your software when but may be necessary for your software when doing label validation or issuing. Julian date doing label validation or issuing. Julian date will be expected by software for ISBT units.will be expected by software for ISBT units.

AABB Accreditation

Must have a written plan in place to Must have a written plan in place to implement ISBT by May 2008.implement ISBT by May 2008.

2525thth Edition of the StandardsEdition of the Standards

ICCBBA Registration

1 Registration per system under the same 1 Registration per system under the same corporate umbrella with same billing address.corporate umbrella with same billing address.Separate Facility Identification Number (FIN) for Separate Facility Identification Number (FIN) for every facility that applies ISBT labels.every facility that applies ISBT labels.Annual license fee to use the coding structure.Annual license fee to use the coding structure.Source for sample barcodes to use for validationSource for sample barcodes to use for validationProgram to search for the barcode you need.Program to search for the barcode you need.Forms to request new product codesForms to request new product codesOngoing maintenance of ISBT 128 for tissue and Ongoing maintenance of ISBT 128 for tissue and cells.cells.

ICCBBA Website New Documents

Product Code Database v 3.1.0Product Code Database v 3.1.0100 new product codes100 new product codes

Product Coding:Bounded Lists and Product Coding:Bounded Lists and Definitions v3.1.0Definitions v3.1.0

Include classes, modifiers, attributes which can Include classes, modifiers, attributes which can be used to search the database. be used to search the database.

Product Code Structure (Blood Product Code Structure (Blood Components) v2.0.0Components) v2.0.0Product Code StructureProduct Code Structure--Cellular Therapy Cellular Therapy v2.0.0v2.0.0Frequently asked questionsFrequently asked questions-- great resourcegreat resource

Where to begin?

Ask software vendor for guidance adding ISBT Ask software vendor for guidance adding ISBT product codes to system tables. product codes to system tables. Identify and list ISBT product codes for every Identify and list ISBT product codes for every

product you manufacture or modify.product you manufacture or modify.Develop your validation plan.Develop your validation plan.Request a variance from FDA for ISBT labelingRequest a variance from FDA for ISBT labeling

Due to anticoagulant appearing below the product Due to anticoagulant appearing below the product name.name.

Hardware Evaluation

Test your scanners ability to scan every field Test your scanners ability to scan every field in every screen.in every screen.

New scanners may be needed that read both New scanners may be needed that read both Codabar and ISBT. Codabar and ISBT.

Scanners must not convert case. Scanners must not convert case.

Find our from your software vendor what Find our from your software vendor what printers are validated with your software.printers are validated with your software.

Printer must be 300 dpi. Printer must be 300 dpi. Must have firmware to print ISBT 128 labelMust have firmware to print ISBT 128 labelOr purchase preprinted ISBT labels if low volume.Or purchase preprinted ISBT labels if low volume.

Blood Center Validation

Include all steps in your process and refine Include all steps in your process and refine plan as needed.plan as needed.

Registering donor with ISBT unit numberRegistering donor with ISBT unit numberComponent preparationComponent preparationEntering testing results Entering testing results Instrument testingInstrument testingLabel printingLabel printingLabel validationLabel validationComponent shippingComponent shippingComponent importingComponent importing

Blood Center Implementation Issues

Obtain ISBT unit number sets.Obtain ISBT unit number sets.Obtain software to format ISBT labels.Obtain software to format ISBT labels.Obtain printers with 300 dpiObtain printers with 300 dpi printheadprinthead and firmware and firmware to print ISBT. to print ISBT. Insure donor testing site can test on ISBT unit Insure donor testing site can test on ISBT unit numbers. If not, identify solution.numbers. If not, identify solution.If doing testing internally make sure all instruments If doing testing internally make sure all instruments can read ISBT barcodes on testing tubes. can read ISBT barcodes on testing tubes. Determine whether instruments can discriminate if Determine whether instruments can discriminate if testing both testing both Codabar Codabar and ISBT on same batch.and ISBT on same batch.

Blood CenterImplementation Issues

Obtain plasma boxes with opening big enough to Obtain plasma boxes with opening big enough to apply 4X4 label.apply 4X4 label.Insure forms and reports have sufficientInsure forms and reports have sufficientspace for 13 character unit number. space for 13 character unit number. Create templates with product barcodes to scan Create templates with product barcodes to scan during component manufacturing.during component manufacturing.Notify customers and provide sample labels for Notify customers and provide sample labels for system validation.system validation.Submit labels to FDA for approval if products are Submit labels to FDA for approval if products are licensed.licensed.

Transfusion Service Validation

Include all steps in your process and refine plan as Include all steps in your process and refine plan as needed. needed. Component shipping/importingComponent shipping/importingComponent modification (pooling, thawing, Component modification (pooling, thawing, irradiation,irradiation,leukoreductionleukoreduction))Modified label printingModified label printingModified label validationModified label validationProduct ID Tag printProduct ID Tag printComponent issueComponent issueComponent billing Component billing

Transfusion Service Implementation Issues

Registration with ICBBA is required if you apply ISBT Registration with ICBBA is required if you apply ISBT 128 labels. 128 labels.

Pool Pool -- new ISBT pool number requirednew ISBT pool number requiredAliquotAliquotIrradiate or Irradiate or LeukoreduceLeukoreduceThaw FFPThaw FFP-- if not transfused within 24 hrs must be if not transfused within 24 hrs must be relabeled as plasma.relabeled as plasma.

Plan for modified product labeling. (preprinted labels Plan for modified product labeling. (preprinted labels or on demand printers and software.)or on demand printers and software.)Plan for labeling during system downtime.Plan for labeling during system downtime.Obtain labels for validation from suppliers.Obtain labels for validation from suppliers.Notify nursing that unit numbers will be longer and Notify nursing that unit numbers will be longer and check that infusion records have space.check that infusion records have space.

Pooling Platelets

New donor identification number (DIN) New donor identification number (DIN) is required.is required.Pooling facility appears in upper left Pooling facility appears in upper left quadrant where the collection facility quadrant where the collection facility usually appears.usually appears.

Modified Labels

Leukoreduction or irradiation of products from another facility requires the modifying facility and FDA registration number and US License number to appear in the lower right quadrant on the label.The collection facility and FDA registration number and US License number appears in the upper left quadrant.

ISBT 128 Quality Improvements

Complying with the ISBT 128 standard Complying with the ISBT 128 standard ensured that multiple vendorensured that multiple vendor’’s software s software worked together without customization.worked together without customization.

Ability to scan every field every time.Ability to scan every field every time.ISBT 128 data structures clearly define ISBT 128 data structures clearly define each field.each field.


Better tracking by unit, product, and Better tracking by unit, product, and collection facility due to unique unit numbers.collection facility due to unique unit numbers.No possibility of running out of unit numbers No possibility of running out of unit numbers or duplicating another collection facility.or duplicating another collection facility.

ISBT Unit Number (BUI)W044604123456 K

Country Code (W for USA) Country Code (W for USA) 4 Digit Collection Facility ID4 Digit Collection Facility ID2 Digit Year of Collection2 Digit Year of Collection6 Digit Unit Serial Number 6 Digit Unit Serial Number (999,999 units)(999,999 units)Calculated Check DigitCalculated Check Digit

Calculated on the 13 Character BUICalculated on the 13 Character BUISupports Accurate Manual Data EntrySupports Accurate Manual Data EntryNonNon--data Character (Not in Barcode)data Character (Not in Barcode)

Reprinted with permission of Suzy Grabowski GCRBCReprinted with permission of Suzy Grabowski GCRBC

ISBT Expiration DateGregorian vs. Julian(Eye-readable vs. Barcode)

12/24/2001 vs. 001358 =>cyyjjj

=>=> ISBT Data IdentifierISBT Data Identifiercc Century (Century (22000000 -- 22009999))yyyy Year (Year (202001 01 -- 202099)99)jjjjjj Julian Date (001 Julian Date (001 -- 365)365)



Better tracking of multiple products collected Better tracking of multiple products collected by apheresis due to unique product codes. by apheresis due to unique product codes. (Platelet co(Platelet co--components, double RBC).components, double RBC).

Type of donationType of donation-- volunteer or paid is requiredvolunteer or paid is requiredType of donationType of donation-- autologousautologous, directed, is not , directed, is not required but helpful.required but helpful.O default is not allowed by FDA on O default is not allowed by FDA on transfusabletransfusableproducts.products.

ISBT Product Barcode

=<=<E0000E0000ttddss=<=< ISBT Data IdentifierISBT Data IdentifierE0000E0000 ISBT Assigned Product CodeISBT Assigned Product Codett Donation CodeDonation Codedd Division of Primary ProductDivision of Primary Productss Split of a DivisionSplit of a Division


ISBT Product Barcode

=< E0000=< E0000ttddssE0332E0332 LR IRR RBCLR IRR RBCE0332E0332VV LR IRR RBC LR IRR RBC VolunteerVolunteerE0332E0332VV0000 LR IRR RBC LR IRR RBC Volunteer Volunteer

UndividedUndivided//No SplitNo SplitE00332E00332VVAA00 LR IRR RBC LR IRR RBC VolunteerVolunteer

1 Division1 Division//No SplitNo SplitE00332E00332VVAAaa LR IRR RBC LR IRR RBC VolunteerVolunteer

1 Division1 Division//1 Split1 SplitReprinted with permission of Suzy Grabowski GCRBCReprinted with permission of Suzy Grabowski GCRBC


Platelet and RBC donationPlatelet and RBC donation

E3087E3087VV0000 Apheresis platelets product#1 Apheresis platelets product#1

E3088E3088VV0000 Apheresis platelets product#2 Apheresis platelets product#2

E0605E0605VV000 0 Apheresis RBC Apheresis RBC


Platelet and Plasma donationPlatelet and Plasma donation

E3077E3077VV0000 Apheresis plateletApheresis platelet––single productsingle productE1613E1613VV0000 Apheresis plasma 400Apheresis plasma 400--600ml600ml


Directed double RBC donationDirected double RBC donation

E0693E0693DD0000 Apheresis RBC product#1Apheresis RBC product#1E0694E0694DD000 0 Apheresis RBC product#2Apheresis RBC product#2


RBC donation typeRBC donation type

E0195E0195AA0000 CPDCPD--A1 RBCA1 RBC-- Autologous Autologous E0195E0195DD000 0 CPDCPD--A1 RBCA1 RBC-- DirectedDirectedE0195E0195VV0000 CPDCPD--A1 RBCA1 RBC-- AllogeneicAllogeneic


Better inventory management of autologous and Better inventory management of autologous and directed products. directed products.

Type of donation included in product code.Type of donation included in product code.Intended use included in ABO/RH.Intended use included in ABO/RH.

If directed is to be crossed over it should not If directed is to be crossed over it should not be encoded in the ABO/RH. Use Not Specified be encoded in the ABO/RH. Use Not Specified --AllogeneicAllogeneic..

ApheresisApheresis is now a modifier and not part of is now a modifier and not part of component class and should appear above the component class and should appear above the product class on the label. US v2.0product class on the label. US v2.0

ISBT Blood Group Barcode

=% =% ggggrree

=%=% ISBT Data IdentifierISBT Data Identifiergggg ABO/ABO/RhRh + + Intended UseIntended Userr KellKell / / RhRh / / MiltenbergerMiltenberger Phenotype Phenotype

(Not Used In US)(Not Used In US)ee Future Use by ICCBBAFuture Use by ICCBBA


ISBT Blood Groups=%=% ggggrere

99770000 O NEG O NEG Autologous Use OnlyAutologous Use Only

99880000 O NEG O NEG AutologousAutologous Only BiohazardOnly Biohazard

99550000 O NEGO NEG Not Specified (Allogeneic)Not Specified (Allogeneic)

99110000 O NEG O NEG Directed OnlyDirected Only

551100 00 O POS O POS Not Specified (Not Specified (AllogeneicAllogeneic))

66220000 A POSA POS Not Specified (Not Specified (AllogeneicAllogeneic))

88440000 AB POSAB POS Not Specified Not Specified ((AllogeneicAllogeneic))



Label for products modified in Transfusion Label for products modified in Transfusion Service much improved. Service much improved.

4X4 full face label can be printed for every 4X4 full face label can be printed for every product.product.Label validation software insures correct label.Label validation software insures correct label.Compare printer costCompare printer cost vsvs preprinted label cost.preprinted label cost.

CodabarCodabar Platelets can be pooled and assigned Platelets can be pooled and assigned ISBT pool number and relabeled as ISBT ISBT pool number and relabeled as ISBT product with full face label.product with full face label.

This may be software dependentThis may be software dependent..

Insert picture 3Insert picture 3-- Codabar Codabar labeled unit side labeled unit side by side with ISBT labeled unitby side with ISBT labeled unit


Eliminated preprintedEliminated preprinted codabarcodabar product product labels and handwritten expiration dates.labels and handwritten expiration dates.

Now used for remaining Now used for remaining Codabar Codabar products products only.only.


Standardization in ISBT 128 barcode labels Standardization in ISBT 128 barcode labels enable software applications to be written to enable software applications to be written to check product and patient identification prior check product and patient identification prior to administration to prevent errors.to administration to prevent errors.

One application has already received 510K One application has already received 510K clearance. We have installed Care Fusion clearance. We have installed Care Fusion BloodCareBloodCare..Allows software safety checks to extend Allows software safety checks to extend from blood donation to patient transfusion.from blood donation to patient transfusion.

References

AABB WebsiteAABB WebsiteFDA WebsiteFDA Website

www.www.fdafda..govgov-- Guidelines for IndustryGuidelines for Industry-- Bar Bar Code Label requirements.Code Label requirements.

ICCBBA Web SiteICCBBA Web Sitewww.www.aabbaabb.org.org--AABB ISBT Implementation Plan AABB ISBT Implementation Plan www.www.iccbbaiccbba.com.comComplete List of ISBT 128 Product CodeComplete List of ISBT 128 Product CodeUS Industry Consensus Standard for Uniform US Industry Consensus Standard for Uniform Labeling of Blood & Blood ComponentsLabeling of Blood & Blood ComponentsMembership InformationMembership Information

Date post:	03-May-2018
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