sábado, 28 de abril de 2012

Vaccines: Pubs/VIS Barcodes

Vaccines: Pubs/VIS Barcodes

Barcodes on Vaccine Information Statements


Barcodes Added to VIS

Beginning in April 2012 new and updated VISs will contain a 2D Barcode.
As part of a modernization initiative, CDC is adding two-dimensional (2D) "data matrix" barcodes to Vaccine Information Statements. Currently this technology is designed primarily to help immunization providers record required information about the VIS, by allowing them to scan the name and edition date of a VIS into an electronic medical record, immunization information system, or other electronic database.
Image of 2D barcode
Figure 1: A two-dimensional Data Matrix barcode
Click image to see larger
NOTE: Scanning the barcode instead of manually recording the information is optional.

What will be required for use of barcodes

Using these barcodes will require a 2D barcode scanner and software that is programmed to accept and process data contained in the VIS barcodes.
First, you need to configure your computer systems to accept the information from the scanner. Second, you need to acquire a barcode scanner that supports reading Data Matrix barcodes.

Answers to Frequently Asked Questions

See the following "Frequently Asked Questions" for more information.
Information for EMR Vendors/Programmers and Immunization Grantees:
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FAQs (in general) about Barcodes

  1. What is the purpose of the barcode on the bottom of the VIS?
    The purpose of the barcode on the bottom of the VIS is to provide an opportunity to electronically capture the VIS document type (e.g. influenza, MMR) and the edition date of the VIS, as required by the National Childhood Vaccine Injury Act (NCVIA). Providers will have the option to scan the VIS barcode instead of manually recording this information. Use of the barcode will not be required.
  2. Are there any benefits to scanning the 2D barcode?
    Scanning the 2D barcode may reduce the time needed to record the VIS information and, more importantly, also reduce the chance of errors in transcribing this information. Additionally, in the future electronic media records (EMR) vendors may support reading the 2D barcode into the EMR system and validate it against the vaccine administered to the patient.
  3. What information does the barcode contain?
    The new 2D barcode contains the VIS document type (e.g. influenza, measles/mumps/rubella) and the VIS edition date.
  4. Do immunization providers have to do anything new or different with the new VIS, now or in the future?
    You can continue to record the VIS document type and edition date manually, as you do now. Once you obtain a barcode scanner and program your computer systems to accept the data from the VIS barcode, you will be able to scan the barcode to enter the name and edition date into the system.
  5. What is the relationship between the VIS barcode and the proposed 2D barcodes on vaccine vials and syringes?
    There is no relationship between the VIS barcode and the proposed 2D barcodes on vaccine vials and syringes. Both barcodes are Data Matrix barcodes, but they contain different information. The proposed vaccine barcodes contain a global trade item number (GTIN) to identify the product (and also manufacturer), and the vaccine's expiration date and lot number.
  6. Is there anything else we should know about this change to the VIS?
    To take advantage of this technology, your computer systems will need to be updated. Various technical changes will need to be made to your computer and EMR systems. See the sections below for more information.
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FAQs from Providers

  1. Is there any advantage to scanning the barcode if an office uses only paper records?
    No. Scanning the VIS barcode will typically only benefit immunizers who use some form of an electronic record-keeping system.
  2. What are the first steps we need to do to use the VIS barcodes in our office?
    First, you need to configure your computer systems to accept the information from the scanner. Second, you need to acquire a 2D barcode scanner that supports reading Data Matrix barcodes.
  3. What should I do if the barcode information does not populate the EMR?
    If the barcode information does not populate the electronic media record (EMR), enter the VIS document type and the edition date manually, without the scanner. Ensure that your barcode scanner supports reading 2D barcodes, and that your software is configured correctly. If you believe the error is with your barcode scanner, contact its manufacturer or retailer. If you believe the error is with your software, contact your technical support representative.
  4. We use photocopies of the VISs. Will that cause problems scanning the barcode?
    No, using a photocopy of a VIS should not be an issue. However, we recommend you have one master copy, and make copies only from that master. The quality of the barcode and the probability that the scanner will not be able to read the barcode increases as the number of copies of a copy increases.
  5. I copy the VIS onto colored paper. Will that cause problems scanning the barcode?
    No, using colored paper should not be an issue. Barcode scanners have the most difficulty reading barcodes on darker papers, such as dark greens and blues. If you have trouble scanning a VIS barcode on a dark paper, try using a lighter color.
  6. Will laminating copies of the VIS cause problems scanning the barcode?
    No, using laminated copies should not be an issue. Barcode scanners can capture the barcode on VISs that are laminated or stored in plastic sleeves.
  7. Will there be different barcodes for non-English translations of VISs?
    No. Because the information is the same on the English and non-English versions of the VIS, the 2D barcodes will also be the same, representing the same document type and edition date.
  8. This barcode looks different from the ones I usually see, what is the difference?
    There are two primary types of barcodes, linear and 2D. Linear and 2D barcodes serve the same purpose, however 2D barcodes can store more information in less area.
    image of linear barcode
    Figure 2
    Linear barcode for Anthrax VIS
    image of 2D barcode
    Figure 3
    2D barcode for Anthrax VIS
  1. Will we have to start scanning the VIS?
    No, scanning the barcode instead of manually recording the information is optional.
  2. What costs are associated with using the VIS barcode?
    Some costs will have to be incurred to adopt this technology. For example, a barcode reader will have to be obtained (typically they can start at about $300.00) and some software or configuration changes may be needed to translate the barcode information to the fields in your computer system.
  3. Will CDC subsidize any costs associated with adopting this technology?
    No.
  4. When I scan the barcode in to my computer system, I see numbers, not text. Is this correct?
    No. Your software system should be able to translate those numbers into the VIS document type and edition date. If you do not see a text description of the VIS document type, contact your software vendor.
  5. Currently, we scan the linear barcodes on vaccines but this barcode is different. Will we have to change our barcode scanning devices?
    It depends. Some barcode scanners support reading 2D barcodes as well as linear barcodes. Others, usually older models, can only read linear barcodes. In the future if you wish to read the 2D barcode, you may need to purchase a new barcode scanner. A 2D barcode scanner that can read Data Matrix barcodes will also be necessary to read 2D barcodes on vaccine vials and syringes. See question 5 under "General FAQs" for more information.
  6. If I purchase a 2D barcode scanner now, when will I need to replace it with a new one?
    Typically for accounting purposes, 2D barcode scanners are expected to work for five years.
  7. What will my electronic medical record (EMR) vendor need to do so I can scan the barcode information into my system?
    Your electronic medical record vendor may need to add fields to the EMR to contain the VIS document type and edition date. In addition, they will need to access a "lookup table" provided by CDC, to translate the numerical data stored in the barcode and determine the VIS document type.
  8. What kind of barcode scanner do I need to read the barcode?
    You need a barcode scanner capable of decoding a 2D Data Matrix barcode, which are offered by many manufacturers. We do not recommend a particular manufacturer. The American Academy of Pediatrics has a guide on choosing a barcode scanner. See the section Choosing a Barcode ScannerExternal Web Site Policy in the Clinical Guidance document found on AAP’s website.
  9. How do I record the Multiple Vaccine VIS in an EMR system?
    Just like the other VISs, the Multiple Vaccine VIS will have its own barcode containing the VIS document type and edition date. Scan the Multiple Vaccine VIS separately for each vaccine for which it was used.
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FAQs from EMR Vendors

  1. What new data does our application need to accommodate?
    There are two fields contained in the 2D barcode on the VIS. The first field is a code that identifies the VIS document type (MMR, seasonal influenza, anthrax, etc.). The second field is the edition date of the VIS.
    The data structure for the code is a GS1 Global Document Type Identifier (GDTI). The GDTI Application Identifier is (253). There is a "lookup table," which lists the VIS document type, its associated code, and related information. The data structure for the edition date is YYMMDD. The edition (publication) date Application Identifier is (11). We expect that EMR vendors can translate the GDTI to the VIS document type and edition date to an easily understood date format.
  2. What customized needs will our customers have in capturing/reporting new VIS data?
    Immunizers will need the barcode data (i.e. GDTI and the VIS edition date) translated into unambiguous text description. Many systems today record the vaccine administered as a proxy for the VIS document type. However, if a system wants to record the VIS document type provided to the patient, a new field for the VIS document type could be used. The GDTI’s associated VIS document type would populate this field.
  3. Will our customers be required to make these changes?
    Presently, providers are not required to record VIS information electronically, nor are there plans to require them to do so.
  4. Will providers need to provide grantee IIS with new 2D barcode data?
    There is no expectation that the addition of a barcode to the VIS will change reporting requirements to grantee IISs.
  5. Does CDC plan to subsidize or otherwise incent EMR developers for incorporating the new VIS data coding?
    The CDC has no plans to subsidize or otherwise provide incentives to EMR developers for incorporating the new VIS data coding.
  6. Should this information be included in the HL7 messages or reported to the IIS?
    Currently, there is no federal requirement to report this information to the IIS. However, HL7 does have LOINC Codes 29768-9 and 29769-7 for “Date Vaccine Information Statement Published” and “Date Vaccine Information Statement Presented”, respectively. A LOINC Code for the VIS document type is planned to be added to the HL7 implementation guide in 2012. Detailed message specifications are included in the HL7 implementation guideExternal Web Site Policy.
  7. Are technical specifications available for the data embedded in the new VIS?
    Yes. Please see the GS1 websiteExternal Web Site Policy for more information regarding the Data Matrix barcode and the data elements for GDTI and edition (publication) date. The GDTI is the first data element in the barcode and the edition date is the second data element in the barcode. A short summaryExternal Web Site PolicyAdobe Acrobat print-friendly PDF file [126KB, 4 pages] can also be found on the GS1 website.
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FAQs from Grantees

  1. Does CDC require any new reporting from the VIS barcodes?
    No. The CDC does not require new reporting from the VIS barcodes which contain information on the VIS document type and edition date. The reporting process by grantees and immunizers should remain the same.
  2. How will our providers report the VIS data to a grantee system, such as a registry?
    The barcoded information does not contain any data that is not currently on the VIS, and there is no requirement that immunizers supply VIS data to the grantees. However, there is no LOINC code for the VIS document type. The HL7 implementation guide is being adjusted to include the VIS document type. See question 6 of "FAQs for EMR Vendors" above.
  3. What are the costs associated with recording the VIS information in our registry?
    Those costs vary by grantee, depending on the systems already in place. If the grantee does not require the transmission of the two VIS data items, then there are no additional costs. However, if the grantee chooses to collect this information, then the costs will vary, depending on the systems already in place, the software used, and the extent of software modification required.
  4. Will any changes be mandated?
    No. There is not a requirement to scan the VIS information. Providers may continue entering this information manually as they do now.
  5. Will we have to change the structure of our IIS?
    It depends. The IIS structure will only need to change if you want to record the VIS document type as a separate field as opposed to using the vaccine administered as a proxy for the VIS document type.
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Converting Barcode Data into English


Translating the VIS 2D Barcode Numbers to Human Readable Text

When a VIS barcode is scanned, it is input into the EMR, IIS, or other computer system as a series of digits. The computer system must be programmed to translate this coded entry into “human readable” text, identifying the VIS name (i.e., the name of the vaccine) and the VIS edition date.
For example, 253088698300001111110714 translates to “Adenovirus VIS, 7/14/2011.”
Each 2D barcode consists of two fields, each preceded by a “GS1 Application Identifier" (AI). The first field is an 11-digit code that identifies the VIS document type (e.g., MMR, influenza, anthrax) and is preceded by the AI (253). The second data item, the edition date or publication date, is preceded by the AI (11). The data structure for the edition date is YYMMDD. (The AIs are highlighted in the above example to show their positions.)
The vendor will need to access a “Lookup Table” to associate each code with its “human readable” equivalent:
EMR vendors may also need to add fields to the EMR to record the VIS document type and edition date. Currently, the VIS document type may not be recorded; the actual vaccine administered may be used by providers as a proxy.

Lookup Table Description

The VIS-Lookup-Table consists of six columns, with a row for each VIS code:
  1. The first column, "VIS Document Type Description / Concept Name," shows the human readable text of the VIS.
  2. The second column, "Edition Date," shows the edition or publication date, using the month/day/year structure, as it appears on the VIS, e.g. 7/14/2011.
  3. The third column, "VIS Fully-encoded text string," shows the code for the entire barcode numerical sequence. This code contains both data items, including the AIs.
  4. The fourth column, "VIS GDTI document code / Concept code," shows the code for the document type. This is the same code as the first field of the VIS Fully-encoded text string (column 3). It is included to give vendors another option when structuring the translation.
  5. The fifth column, "Edition Status," indicates whether the VIS represented by each row is the current, or a past, edition. When a VIS is updated, a new barcode must be generated to reflect the new edition date. Both current and historical codes will be maintained in the VIS Lookup Table. While edition dates will change over time, the VIS GDTI document code will remain the same.
  6. The sixth column, "Last Updated Date," shows the date of change in the VIS Lookup Table. This can be used to identify new table additions.

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