Link - http://www.fda.gov/cber/faq/barcodefaq.htm

Frequently Asked Questions

Bar Code Label Requirements for Blood and Blood Components

Is it true that we must label blood and blood components with specific machine-readable bar code information by April 26th, 2006?

• Yes, under the bar code label requirements final rule of Feb 26, 2004, products subject to the rule, including blood and blood components intended for transfusion, must be in compliance by April 26, 2006. The regulation for blood and blood components is located at 21 CFR 606.121©(13). The final rule is entitled: Bar Code Label Requirement for Human Drug Products and Biological Products (69 Federal Register 9120, February 26, 2004).

What machine-readable information is required for blood and blood components?

• 21 CFR 606.121©(13)(ii-iii) states the container label must bear encoded information in a format that is machine-readable and approved for use by the Director, Center for Biologics Evaluation and Research.
• Currently, two types of machine-readable label types are recognized by FDA: FDA recognized the use of Codabar (a specific bar code symbology) in 1985; and FDA accepted the use of ISBT 128, version 1.2.0, in 2000.
• Each label must have at a minimum: (A) A unique facility identifier; ( Lot number relating to the donor; © Product code; and, (D) ABO and Rh of the donor.

We are a transfusion service and very infrequently prepare split units, pediatric units, and pooled cryoprecipitate units; do we need machine-readable labels for these units?

• Yes, This situation was described in the preamble to the proposed rule (68 Federal Register 12500 at 12513):
• "The unit of blood or blood component label would contain the machine-readable information if the blood or blood component has any possibility of being transfused to a patient, whether or not the unit is actually transfused. Additionally, the phrase, "from which the blood or blood component can be taken and transfused to a patient" would include the circumstance where blood or a blood component is extracted or aspirated with a syringe from the container of blood or blood component in order to transfuse to a patient. This technique might be used when transfusing neonates or under other medically necessitated circumstances. In this case, the blood or blood component from which the aspirate is taken must have affixed to it a label containing the required machine-readable information. This would be consistent with the pre-existing requirement at § 606.121©(8)(iii) that requires specific statements if a product is intended for transfusion."

I have questions about how to encode facility identifiers and product codes for pooled and aliquoted units for Codabar or ISBT 128? Where do I get information about these issues?

• Please contact CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) at matt@cber.fda.gov for additional information. The regulation requires a unique facility identifier.

How will FDA evaluate compliance with the rule?

• Our investigators will evaluate compliance with these regulations during routine inspections of blood establishments.

May I request an exception or alternative under 21 CFR 640.120 for this requirement of the blood and blood component container label regulations?

• The purpose of the bar coding rule is to reduce transfusion errors and increase patient safety. CBER will carefully review any request for exception or alternative. The bar code regulation for drug products recognizes that exemptions may be warranted when compliance would adversely affect the drug’s safety, effectiveness, purity or potency or not be technologically feasible. In the preamble to the rule discussing exemptions for drug products, FDA noted that almost all drug products are capable of bearing a bar code. FDA noted that we would not consider written requests based on reasons such as financial reasons, a claimed low rate of medication errors, or a claim that the product is unique such that medication errors do not occur or rarely occur. In assessing requests for exemptions for blood and blood components, FDA would follow the same approach as that described in the drug regulations (21 CFR 201.25(d)).

Updated April 7, 2006

Do you know what the FDA is recommending to use as the ABO/Rh of pooled products, i.e. cryo?

Good question.

I just emailed FDA, I'll post my response from them once I receive it.

This isn't from the FDA but...

Another BB supervisor I talk to often said her site will use small barcoded ABORH labels for cryo and Plt pools with different ABORH types in the pool. She said they will apply an ABORH label for each ABORH type in the pool. If the small barcoded ABORH labels do not fit in the section of the base label for ABORH type then the labels will be applied on the bag along the top or bottom of the base label. She did say that these labels have an FDA approved adhesive.

I believe Shamrock makes this type of small barcoded ABORH labels. I also believe that SHamrock's BB labels meet FDA requirements for adhesive but check that out before purchasing.

I have received a response from FDA. They essentially stated it is best to only pool the same type, and if we need to pool different types we should apply each type label to the bag. So to reference Mindy's post above, it looks like the supervisor she referenced was right on the money.

I have requested from FDA that they allow me to post the entire email response. I'll let you know as soon as I get a reply.

FDA RESPOSNE

Cliff:

The information CBER provides is considered "public information" and you are free to post it. However, my e-mail to you was a direct response to your questions and may not apply to questions from others. Additionally, my e-mail is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

For contact information, please include the e-mail address for CBER's Manufacturer's Assistance Account:

matt@cber.fda.gov

Dear Cliff:

Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding the bar code rule. CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

You should preferably only be making pools of the same ABO type. The first version ISBT 128 bar codes only allow for pools of the same ABO blood types and this basically applies to Codabar. Please note that the number of units in the pool and their ABO group and Rh type either must be on the label or on an attached tie tag. The identification numbers of the individual units in the pool should be a part of your facility records. The pool number must be machine readable. The individual units numbers that are part of the pool should not be placed on the pooling bag at all. A separate record should be kept of the individual unit numbers in the pool along with the related assigned pooling number. We have told facilities that in cases where they can only use mixed blood types, the following solution would be acceptable: to affix each individual blood type label to the pooling bag.

Whenever the product from the original bag is placed into an unlabeled empty satellite bag, the facility identifier should be that of the facility that performs the pooling or dividing.

The following links may be helpful to you:

http://www.fda.gov/cber/gdlns/barcode.htm

http://www.fda.gov/cber/gdlns/unilabel.pdf

Also, this presentation given by CBER's Associate Director for Policy on bar code requirements:

http://www.fda.gov/cber/summaries/bldreg011706dm2.pdf

I hope this is helpful. If you have further questions, please contact me again.

Do you know a place where I can buy barcoded pool label(for pooled cryo)?

Try Shamrock @

http://www.shamrocklabels.com/

or Veriad(UAL) @

http://www.rrdonnelly.com/wwwRRD/Services/Produce/Labels/UnitedAdLabel/UnitedAdLabel.asp

We have ordered BX681 (pooled plt) and BX375 (pooled cryo) from them in the past. (This was a while ago and the numbers may not be current.) You may need to call them.

Linda Frederick

How is everyone handling the new requirement that you must have a unique facility identifier for modified and pooled product labels?

bbirder (and all)

If you are applying labels directly to the product, I'd ask for verification from the vendor that the labels are approved for direct adherence. Many years back, we tried to order labels from UAL and they told us their labels were not approved for direct adherence.

Mary,

When we relabel a product it has our facility registration in the ABO label.

Also, when we irradiate a product we use a RadSure and add an additional sticker that says Irradiated by Our Hospital, Registration #######

We do not have our FDA number so we are planning to use our CLIA#.

We do not have our FDA number so we are planning to use our CLIA#.

I don't understand.

Do you modify products that would require you to relabel them? If so, I suspect you must be FDA registered. The regisration number is on your annual registration form, and at the FDA site, click here.

All we do is split(for peds) and pool(cryo) products. I decided to use CLIA number from the information I got from AABB Forums:ASCC administrative forum...Barcode Labeling Rule for Split and Pooled Blood Products....

Gosh, we are all going to "go broke" buying labels!

How is everyone handling the new requirement that you must have a unique facility identifier for modified and pooled product labels?

I have been told Shammrock will make these labels for you with a readable barcode. The facility identifier is your facility if you are pooling plasma products, aliquoting pediatric units or reconstituting whole blood for exchange transfusion.

The FDA ruling states "Each label must have at a minimum (A) A unique facility identifier; ( Lot number relating to the donor; © Product code; and (D) ABO and Rh of the donor." http://www.fda.gov/cber/faq/barcodefaq.htm

The only problem I see with these requirements is obtaining a barcoded pool or aliquot number. Most systems assign these numbers and if they cannot print a barcode then they will not be in compliance.

A vendor can print the ABO/Rh, facility name, and component barcodes for you. They may have to be custom made, however, they may already be making these as everyone is in the same situation.

If I had to pool units of a different ABO/Rh then I would make two or more pools to satisfy this requirement.

Hope that helps and thanks for letting me add a little.

M Lister

Do you know a place where I can buy barcoded pool label(for pooled cryo)?

List of Label Companies

BD

1 Becton Drive MC314

Franklin Lakes, NJ 07417

www.bd.com

Care Fusion

1430 Spring Hill Road

Suite 510

McLean, VA 22102

703-714-0730 FAX: 703-714-9295

kathryn.sellers@carefusion.com

www.carefusion.com

Chek-Lab, Inc

PO Box 4455

Aurora, IL 60507

TEL: 630-896-0574 FAX: 630-896-0665

cheklab@xnet.com

Computype, Inc

2285 West County Road C

St. Paul, MN 55113-2567

TEL: 800-328-0852 FAX: 651-633-5580

Email: Laurie.Kasel@computype.com

www.computype.com

Digi-Trax Corporation

650 Heathrow Drive

Lincolnshire, IL 60069

800-356-6126

info@digi-trax.com

www.digi-trax.com

DataWorks Development

P.O. Box 174

Mountlake Terrace, WA 98043

425-673-1974 FAX: 425-673-2506

gary@dwdev.com

International Specialty Products

1361 Alps Road

Wayne, NJ 07470

TEL: 973-628-3383 FAX: 973-628-3016

Email: RFAIRMAN@ISPCORP.COM

www.ispcorp.com

Lattice, Inc.

1751 S. Naperville Road

Suite 100

Wheaton, IL 60187

TEL: 630-949-3250 FAX: 630-949-3299

Email: peterm@lattice.com

www.lattice.com

Mediware Information Systems, Inc.

Blood Bank Division

1900 Spring Road

Oak Brook, IL 60523

www.mediware.com

Schreiner Scientific Specialty System

Bruckmannring 22

D-85764

Oberschleissheim,

TEL: +49 89 31584-5400 FAX: +49 89 31584-5422

Email: steuerer@schreiner-medipharm.com

Shamrock Scientific Specialty System

34 Davis Drive

Bellwood, IL 60104

TEL: 800-323-0249 FAX: 800-248-1907

Email: sales@shamrocklabels.com

www.shamrocklabels.com

Typenex

303 E. Wacker Drive

Suite 311

Chicago, IL 60601

TEL: 866-897-3639 FAX: 312-297-7090

Email: erinm@typenex.com

www.typenex.com

Watson Label Products

10616 Trenton Ave

St. Louis, MO 63132

TEL: 800-678-6715 FAX: 314-493-9399

Hope this helps

We had our labels custom made by Centurian Label Systems in Howell, Michigan. There number is 1-800-248-4058 and web address is www.tshsc.com. Our quality specialist compared them with Shamrock and was happy with their product.

If you have interest in printing all required ISBT128 labels in your facility Digi-Trax Corporation has both a stand-alone PC system and an interfaced system...Hema Trax.LPS. We have Hema Trax interfaced or in process of interfacing to almost every computerized blood bank management system in the US. For details look at www.digi-trax.com or contact: 800-356-6126, info@digi-trax.com.; Fax 847-465-9055( 650 Heathrow Drive; Lincolnshire,IL 60069 )

I am planning to use Design Pro 5 limited edition(Avery.com) to make barcoded pool number.

Digi-Trax has Windows label design software that will drive most every popular thermal printer. You can design and save label designs and print from blank labels. The software from NiceWare International ( www.nicewareintl.com ) will also take data from most any data base. See www.digi-trax.com or contact info@digi-trax.com. Free demo versions are available.

You can buy all your labels from www.barcodeswest.com Talk to Mr. Brown

Has anyone using Safetrace bloodbank software have any success with ISBT implementation for unit labels and syringe labels. We are a transfusion service with many pedi patients and we do about 2000 units of rbcs and 1000 units of plasma products. We receive everything from the same supplier which has not yet been able to get ISBT loaded and it will not be for several years. [i personally do not understand why such a cumbersome system should be implemented. The ISBT is extremely formidable to many software and hardware systems. Why is there such a rush to advance this technology. I believe we are doing fine with the systems that are in place.]