Introduction

This implementation plan guidance has been prepared by the international Cellular Therapy Coding and Labeling Advisory Group (CTCLAG) to assist cellular therapy facilities with implementation of ISBT 128. The group has identified and addressed issues related to ISBT 128 implementation and logistics. Information provided is intended to be used as a guideline to be modified as necessary for each site.

It should be noted that this document was written with an international audience in mind. It therefore does not endeavor to give details about specific standards or national/supranational regulatory requirements. The user is responsible for adhering to applicable requirements.

This plan should be read and used in combination with the accompanying paper Terminology and Labeling of Cellular Products—1. Standards, and the ISBT 128 Standard Technical Specification.¹ These standards will be incorporated into future editions of the ISBT 128 Standard Bounded Lists and Definitions and the ISBT 128 Standard Product Code Structure and Labeling (Cellular Therapy).^{2, 3}

This document also assumes that the appropriate staff Medical Director, Laboratory manager(s), Quality Officer, Information Technology manager(s), and other key personnel] have evaluated the benefits and costs of implementing ISBT 128 and the decision to implement it has been made. Therefore, this document is intended to assist this group with the implementation.

Identify project manager

Once the decision to implement ISBT 128 is made, in all likelihood, one person within the institution will orchestrate the facility's conversion into ISBT 128. The earlier this person is identified and willingly accepts the responsibility for the project, the better. This person is identified as the Project Manager. Identifying stakeholders, and obtaining their acceptance and commitment for participation is key to successful implementation of ISBT 128.

Assemble and review educational materials

The Project Manager should assemble pertinent education materials that are readily available regarding ISBT 128. Various resource materials are available [AABB, ICCBBA]. These materials should be studied and utilized in planning, implementation and training.

Executive management buy-in

Once the Project Manager understands ISBT 128 and the impact it will have on operations, the appropriate executive staff (those who may not have taken part in the process of deciding to implement ISBT 128) must be informed of the decision to implement ISBT 128. Discussing ISBT 128 with this staff will enable the team to plan and give the project necessary support. A sample summary of ISBT 128 information that can be used to start this process may be found in Appendix A.

Inform administration and laboratory supervisors about conversion

Informing the laboratory administration and other laboratory supervisors about the pending change to ISBT 128 should be done as well. Cell product facilities operate in a variety of business models with a wide variety of organizational administrative models. Some cell product facilities stand alone; others operate as part of a hospital transfusion service or a blood center. Other laboratories may not be affiliated with a hospital at all. Recognizing the characteristics of your unique situation will help determine other groups with whom you will coordinate. For example, do other departments provide testing services to the cellular therapy lab? If so, they will need to know about the change in Donation Identification Numbers since that will affect sample handling. Inform and involve these affected departments in the planning process.

If your cell collection and/or processing facility are within a hospital but under a different department than the transfusion service, enlist your medical director or administrators to assist with collaboration if issues exist. Given the patient safety considerations and the move in all healthcare facilities towards bar coding technology, resistance will likely be minimal. It is critical to ensure the full buy-in of end users of the products at an early stage in the implementation and involve them in the planning process. This assures the smooth implementation across the organization. This engagement should include 'selling' the benefits of such a change to ensure staff does not see this as only a bureaucratic exercise, but with real benefits for the patient.

To assist in the planning process, samples of labels may be needed. ISBT 128 formatted labels have been available for blood and blood components for several years and samples may be obtained from a variety of vendors. The blood banks and transfusion services who have implemented ISBT 128 can be consulted for assistance with technical support, software use and/or recommendations and label inventory questions.

Change control measures

Once key players are identified and management staff informed, the appropriate change control measures should be followed according to facility standard operating procedures. These measures should include writing a validation plan and an implementation plan, as well as updating the Quality Plan.

Determine level of involvement

The level of involvement will affect the amount of work to be done. The equipment, software and supplies needed, as well as the need to register with ICCBBA, will vary depending on how ISBT 128 is utilized. Costs will vary accordingly. Software may represent the most significant cost but, depending on the operational setting, may not be needed or may already be present. Existing software may or may not require modification or upgrading.

Equipment, software and supplies

A general outline of the equipment, software and supply considerations based on level of involvement is included in Table 1, which focuses on the use of ISBT 128 in labeling. It should be noted that the standard is also suitable for the electronic transmission of information. Use of this feature enables organizations to quickly and efficiently share product information.

Table 1 - Description of preliminary activities needed based on automation levels.

Full table

ICCBBA registration

Early in the process, you will need to determine if you must register with ICCBBA. All facilities that will apply ISBT 128 bar codes on cellular therapy product labels are required to register with ICCBBA. Additionally, vendors who utilize ISBT 128 data structures are required to register with ICCBBA. If your facility handles both hematopoietic progenitor cells (HPCs) and blood, and has already registered with ICCBBA, it is not necessary to register the HPC activities separately. You may contact the ICCBBA office by fax or e-mail to request registration information (or see www.iccbba.org). Once you are registered and licensed, you will be given access to the technical documentation and databases necessary for the implementation of ISBT 128.

Though costs and prices change, registration, at the time of printing this document (2007), costs US$200 (one-time fee) for all facilities. Additionally, an annual licensing fee based on the volume of HPCs or blood collected is due. This is currently US 1.125 cents per unit collected per year with a minimum payment of US$100. Facilities that process, but do not collect HPC products, pay an annual US$100 per year licensing fee. All these fees apply to facilities in countries with a High Human Development Index (HDI) as measured by the United Nations. Countries in Medium and Low HDI pay a reduced fee. For more information, see www.iccbba.org.

Understand product codes

A current list of terms and their definitions used in ISBT 128 may be found in the accompanying Terminology and Labeling of Cellular Products—1. Standards (later to be incorporated into ISBT 128 Standard Bounded Lists and Definitions, available to registered users on the ICCBBA website). The product code database is also found on the ICCBBA website (cellular therapy product codes begin with the letter 'S'). The terminology work group of CTCLAG considered international practices and developed language to allow for future developments. Attempts have been made to ensure harmonization of terminology with various standard setting organizations and with the Circular of Information for the Use of Cellular Therapy Products.⁴

Label design

Label design should follow that outlined in the accompanying article. This document describes the design of both full and partial labels.

Full-size labels are 100 (+/-2) mm 100 (+/2) mm (4 4inches). The minimum information that must be bar coded on full labels includes the Donation Identification Number (which includes the facility identification number), the product code, and the ABO/Rh (when applicable). Other information may be required to be bar coded based on national regulatory requirements.

Information that will be bar coded on partial labels will vary depending on the size of the label and the bar code symbology used. If a linear bar code is used, it may only be possible to bar code the Donation Identification Number. If a two-dimensional (2-D) bar code symbology is used, more information may be encoded. The accompanying article describes these options.

Various standard setting organizations and regulatory agencies may require that other information (for example, the expiration date, if applicable) appear on labels, but not necessarily be bar coded. Be certain to take these additional requirements into account when selecting labels or on-demand labeling software.

Existing inventory

Owing to the labile nature of cryopreserved cellular therapy products, inventory in storage should not be removed and relabeled if there is any risk to the product quality. Rather, ISBT 128 should be utilized on product labels going forward after the cell collection and/or processing facility implementation date.

Obtain equipment, software and supplies

You may need to purchase equipment, software and supplies.

Equipment

Scanners. For those who would read the bar-coded labels, scanners will be necessary. Where ISBT 128-information is being encoded into a linear bar code, Code 128 is used. If a 2-D bar code is used, Data Matrix is recommended.⁵

Most existing bar code scanners should be able to read Code 128 and to auto-discriminate between it and other bar code symbologies. However, these scanners may not be able to read concatenated bar codes. Concatenation allows the reading of two bar codes as a single message, which can improve process control and efficiency. While the ability to read concatenated bar codes is not required, it is a nice feature for improving quality and safety. Some existing scanners may be upgraded to allow concatenation, while others may not. Product documentation or your vendor should be consulted to determine if your scanner(s) has (have) this capability.

Because some labels used for cellular therapy products are very small, 2-D bar codes may be used. As mentioned above, Data Matrix is the preferred symbology for ISBT 128-information. Therefore, if new scanners must be purchased, consideration should be given to selecting an imaging scanner capable of reading both 2-D bar codes and linear Code 128.

If parameters on your scanner may be set to limit which bar code symbologies will be read, they should be set to read only those symbologies that you intend to be read (for example, Code 128, Codabar and Data Matrix).

Label printers. Thermal transfer bar code label printers for on-demand printing have been favored by the vendors of on-demand label printing software and have been successfully employed since the late 1980s in blood banking. It is recommended that printers with 300 dots per inch resolution be used to meet high-density and small-type font requirements needed on partial labels. Full resin-type thermal transfer print ribbons matched to the synthetic label stocks should be used in order to provide the maximum durability.

Software

If you do not have software that supports ISBT 128, you may decide to purchase it or develop it in-house. If you decide to purchase software, you will need to go through supplier qualification and related procedures according to the facility's standard operating procedures. Once a vendor is selected (or in-house developed software is available), develop a validation plan for the installation and functionality testing of the new software. Parallel operation of the current and new systems may be advisable. Remember to include installation, upgrade and maintenance details in agreements and related standard operating procedures. For example, the company may have upgrades available in the future and you might want to negotiate up front how this will be handled, paid for, validated and so on.

Labels

All labels ought to be constructed of materials that will withstand water, freezing, bleach disinfecting, abrasion and other common solvents. There may be regulatory requirements for the type of adhesive used.

Several label options exist.

1. Labels may be ordered from label manufacturers. These may be stock labels or may be custom made for each facility. Vendors that are registered with ICCBBA are listed at http://www.iccbba.org > Registration and Licensing > Licensed Vendors and Software Developers. Collection and expiration dates (with highly variable information) do not need to be bar coded facilitating the purchase of stock labels.
2. Labels may be printed on-demand. Labels may be printed using either stand-alone software; software interfaced to your laboratory or facility software, or be included with your laboratory software. Consult your software vendor to determine what options exist for your system.
3. A combination of pre-printed labels and on-demand labels may be used. Some organizations may choose to purchase some labels where special needs exist (in-process product code labels) but create on demand labels for other needs (for example, final labels where computer control of the labeling process is desired).

Quality control

All new equipment, software, supplies (including labels), and processes must be validated. This should be done according to your facility's policies and procedures, as well as any applicable standards and regulations and vendor recommendations. Valid and invalid labels that may be used for validation purposes may be found on the ICCBBA website.

A special consideration applies to facilities that do not ordinarily scan bar codes. Because such facilities may place bar-coded labels on products that will be shipped to facilities that will read the bar codes, such labels should be validated. Appendix B contains a possible mechanism to validate these labels. Validated bar code scanners from other departments may be used for this purpose.

Please remember that governmental regulations may also apply and compliance with national or supranational directives is the facility's responsibility. Examples of this include, but are not limited to, requirements for adhesives and biologic product handling. As noted in the introduction, these and other requirements are outside the scope of this document.

Planning

Transition phase: not every facility will convert into ISBT 128 at the same time.

• Determine how you will enter, process, dispense and infuse ISBT 128 labeled products if they are received by your institution before your implementation date.
• Consider whether upgrades to current information systems will be needed and when they are going to be available.
• Review labels from potential suppliers to be sure you can read all bar codes on their product labels.
• Incorporate the new labels into your label qualification procedures.
• Determine who is responsible for patient wristband bar coding if your facility uses it. It may be only used for pharmaceuticals or administrative issues currently, but this is likely to be expanded. If possible, work with other departments to select systems that can read both ISBT 128 and bar codes used in other applications
• Since facilities with products in storage will likely not re-label existing products, maintain processes, procedures and training to accommodate these labels.

Costs

As mentioned above, costs will vary significantly depending on the automation level of the facility and its complexity. Rough estimate equipment costs are listed on Table 2, which is accurate as of the time (2007) of printing this document. This is intended to be used only as a guide and neither the CTCLAG nor the sponsoring agencies make warranties or assurances regarding these prices.

Table 2 - Sample components and approximate costs.

Full table

Audit procedures

Audit policies and procedures to ensure that they contain updated ISBT 128 information. Additionally, be sure to modify related plans (for example, Quality, Emergency Response, Contingency, Computer-down or Back-up plans) as necessary.

Registration with governmental agencies

Specific requirements vary between and sometimes, within, countries. It is up to each facility to determine what materials, if any, must be filed with the relevant regulatory agencies.

Develop training materials

Identify who will require training, which standard operating procedures will be involved, and what materials will be needed. Develop a training plan and time line for the training. Remember that anyone who must handle the products (nursing staff, physicians), handle the testing samples (other laboratory personnel), handle the data (Information Technology staff) or must deal with product codes (billing personnel) must receive training on the changes to the system.

Several slide presentations and other training tools are available on the ICCBBA web site.

Assess progress

As a part of the Quality Assurance Plan, track the implementation progress and success. It is important to track progress positively by identifying all equipment, staff, processes and so on, impacted and 'signing-off' against each aspect to gain assurance that the systems and processes in use are 'ISBT 128 ready'. Once ISBT 128 is implemented, evaluate whether it has increased or decreased errors and accidents. This information may be very important when documenting and/or identifying corrections for the errors and accidents identified. In conclusion, the implementation of this system should be rolled into existing systems including quality and process control systems according to facility policies and procedures, similar to the implementation of any new technology system.

The Cellular Therapy Coding and Labeling Advisory Group will continue to monitor the progress of this initiative and, whenever possible, will work to assist facilities in obtaining updated information, educational and training materials. On behalf of the following organizations, we thank you for supporting this improvement in your cellular therapy product facility and in the field, as a whole.

References

1. ICCBBA Inc. ISBT 128 Technical Specification, version 3.0.0. January 2007 ICCBBA Inc. www.iccbba.org ISBN 978-1-933243-02-3. ICCBBA, Inc. 1615 Orange Tree Lane, Suite 200 Redlands, CA 92374, USA. Tel: +1 909-266-3140. Fax: 909-266-1828. E-mail: iccbba@iccbba.org; http://www.iccbba.org.
2. ICCBBA Inc. ISBT 128 Standard: Product Coding—Bounded Lists and Definitions, version 3.3.x. April 2007. http://www.iccbba.org.
3. ICCBBA Inc. ISBT 128 Standard Product Code Structure and Labeling (Cellular Therapy) Version 2.0.0. January 2007. http://www.iccbba.org.
4. AABB. Circular of Information for the Use of Cellular Therapy Products. AABB, American Association of Tissue Banks, American Red Cross, American Society for Blood and Marrow Transplantation, American Society for Apheresis, America's Blood Centers, Foundation for the Accreditation of Cellular Therapy, ICCBBA Inc. International Society for Cellular Therapy, National Marrow Donor Program 2005. http://www.aabb.org.
5. ISO/IEC. Data Matrix Bar Code Symbology Specification, ISO/IEC 16022:2006.

Appendices

Appendix A

Sample educational summary

Several major organizations from North America and Europe have joined to provide recommendations and guidance for implementing an important safety measure for products—machine-readable or bar-coded labels. With an increasing number of products crossing international lines and variability in product naming and processing procedures, significant margin for error exists. These organizations have worked together to develop uniform nomenclature (Circular of Information) and most recently, uniform-labeling requirements.

With this initiative, the most critical information [facility identifier, unique donation identification number, product name and ABO/Rh (if known)] will be both eye- and machine-readable. Additional mandatory information (such as the expiration and collection dates) that must appear on the label may and may not be bar coded, depending on the size of the label and the amount of information required. Attached labels and accompanying paperwork would carry the remaining information. The group has developed all key elements including label templates, terminology and a simple implementation plan. The plan contains basic information and suggestions for all levels of facility automation, from completely manual to completely automated. There are provisions for those who do not have access to automation, but given the patient safety benefits of computer verification of product and patient identity, it is hoped that all facilities will eventually take this approach.

This system for encoding information and standardized labeling is called ISBT 128. ISBT is the acronym for the International Society of Blood Transfusion, which began the effort to standardize labeling worldwide; 128 is the linear bar code symbology ('language') used with ISBT 128. The system has been in use in cellular therapy, blood and tissue banks worldwide for almost a decade.

Appendix B

Bar-coded label validation

Purpose: The purpose of this procedure is to assist in the validation of ISBT 128 bar-coded labels in facilities that apply bar-coded labels but do not normally scan the bar codes.

Scope: This procedure pertains to the scanning of ISBT 128 Donation Identification Number (DIN), ABO and Product Code bar codes.

References: ISBT 128 Standard Technical Specification and User's Manual for bar code scanner.

Equipment: Computer with a text program such as Word or Notepad; Validated bar code scanner capable of reading Code 128; ISBT 128 bar coded labels (Donation Identification Number, ABO/Rh and Product codes).

Procedure

1. Open up a text program (such as Microsoft Word or Notepad) to display the scan output.
2. Plug the scanner into the same computer as your text program. Activate the necessary symbology on the scanner from the User's Manual.
3. Verify whether the scanner can read ISBT 128 data structures by scanning Code 128 bar codes that are usually found in the operator's manual for the scanner.
4. Scan bar codes on a sampling of each type of ISBT 128 labels (Donation Identification Numbers, ABO/Rh and Product Codes) to be validated. The scanned information should appear on the screen in your text program.
5. Compare the output in the text program against the eye-readable text beneath each bar code. Each output should display a data identifier (see Table below) and followed by the eye-readable text. Characters you should see before the eye-readable text are

   

6. The number of labels that must be scanned to validate the labels is dependent on facility policies and procedures.
7. Interpretation:

7.1.

Output should match the data identifier plus the eye-readable text beneath the bar code.

7.2.

An error message, rather than incorrect data, should appear if problems occur.

7.3.

The bar code should be successfully read on the first scan the vast majority of the time.

7.4.

Exact acceptance criteria must be established by each facility.

Acknowledgements

The CTCLAG wishes to thank the additional volunteers who participated in writing and reviewing this Implementation Plan.