Two-dimensional (2D) barcodes have the potential to streamline immunization practices by allowing vaccine information to be documented in an electronic health record (EHR) instantly and accurately, saving staff time and preventing errors.
2D barcoding technology includes:
- product information,
- lot number, and
- expiration date.
For details on implementing 2D barcoding in your practice, view the AAP Clinician Guidance below
AAP Clinician Guidance
Currently there are linear (1-dimensional) barcodes on all vaccine vials and syringes. Linear barcodes contain only a limited amount of information which does not include all of the information that practices are required to record in a patient's chart. 2-dimensional (2D) barcoding technology allows inclusion of most of the pertinent information, with the exception of site/route and administering personnel information. Changing this technology constitutes a label change for manufacturers, which must be approved by the Food and Drug Administration (FDA). Thanks to meetings between the FDA, AAP, and manufacturers, the FDA has set up guidance for manufacturers to apply for an exception to the linear barcoding rules just for vaccines. As of November 2011, manufacturer guidance has been finalized and applications for exceptions should follow soon.
The 2D barcode includes:
- the Global Trade Identification Number (GTIN), which houses the National Drug Code and can be used to determine manufacturer and name of the vaccine,
- the Lot/Batch Number, and
- Expiration Date.
The CDC is adding 2D barcodes to their Vaccine Information Statements (VIS), as well, so that VIS publication date can be included in a medical record or registry. It is important to note that, at this time, 2D barcodes are only being promoted on the vaccine vial or syringe (unit dose). Because of federal efforts around serialization to prevent counterfeit drug distribution, the outer packaging of vaccines will not yet include this technology.
Electronic Inventory Control could result in increased vaccination rates by improved product availability or control and reduction in errors when an alarm alerts user when duplicate or inappropriate vaccine is ordered. Electronic Inventory Control would allow a practice to rectify the physical count of vaccine product with vaccine product billed.
With an Electronic Health Record:
- When a vaccine first comes into the office, enter the inventory module of the EHR.
- Select an entry for a new vaccine.
- Scan a vial from the package and check that the lot number, expiration date, etc have populated correctly.
Without an Electronic Health Record:
- Inventory Control could be done through a Practice Management System if no EHR is available.
- When vaccine product is administered, scan the product into the practice management system to bill it and send it to the immunization registry.
- At certain intervals, rectify the physical vaccine count with the vaccine products billed.
With an Electronic Health Record:
- When patient enters, office reception staff can access state immunization registry or an EHR with decision support and determine if patient is in need of any immunizations. The reception staff can then give the parent/patient appropriate VIS sheets and suggest they review and discuss any questions or concerns with the nurse or doctor. This step helps to avoid missed opportunities and is another way to give the message that the office cares about a family's concerns.
- When patient is examined, physician or other appropriate professional orders the immunization(s) to be administered.
- The EHR checks the order against the patient's record, for verification of need.
- Staff receives the order and obtains the vial.
- Staff scans the vial to determine if it is the correct vial by matching it to the order. Performing the scan from the patient's 'chart' enters the immunization into the patient's permanent record, uploads it to the registry, and subtracts the dose from the practice inventory.
- Vaccine and administration are billed electronically through the practice management system.
Without an Electronic Health Record:
- Physician or other orders immunization to be administered.
- Staff receives the order, verifies the need by checking the patient record, then obtains the vial.
- Staff scans the vial to determine if it is the correct vial.
- If peel off label is available, paste onto the immunization log in the paper chart or print a new immunization log.
- Automatically enters the record of administration and charges into the practice management system (PMS) when the patient's account number is entered.
- Automatically subtracts from PMS inventory module.
(For paper charts. This would happen automatically in an EHR.)
- Some registries will accept information from a Practice Management System.
- If not, log in to the registry and the patient's record. Scan the vial. Consider using the registry for clinical decision support to validate that the correct dose is being administered.
Billed to correct patient or payer
- Send billing information to the correct patient or payer through the Practice Management System.
Separation of VFC and "Private Purchase" Vaccines
2D-barcoding alone is not able to separate VFC and privately purchased vaccines; however, by programming and assigning certain lot numbers or expiration dates to public or private stock, EHR or practice management systems can assist with inventory control of each separate stock. When the vaccine (with lot number assigned in the EHR) is scanned for administration and the wrong vaccine is scanned, the EHR vaccine inventory control system will alert the provider. Currently, providers rely on human recognition of alphanumeric lot numbers of multiple digits in order to keep the inventory separate.
While 2D barcoding is being rolled out, offices will likely have a combination of vaccines that do and do not have 2D barcoding for another year or two. Electronic systems need to be prepared to handle both manual data entry and the scanned entry. Some practices may choose to create their own barcodes for products without it in the interim. Talk to your vendors about how to accomplish this.
This section is written with the help of GS1, a global standards group that has aided the AAP with writing the manufacturers' guidance.
There are a number of providers who make excellent scanning equipment available on the market. Like in any commercial market, different products have different strengths and weaknesses. The exact choice of scanner will depend on many factors including price, operating environment, etc. There are, however, factors which are likely to impact your office:
- Choose only a scanner that is of medical device quality and is "disinfectant ready". Please make sure to check the scanner specification sheet for this specific feature.
- Be sure that the specific barcode reader you are considering for purchase is compatible with, or has the stated ability, to recognize and translate 2D barcodes.
- Software compatibility: discuss functionality with your EHR or registry vendor to ensure that you are purchasing a brand that will work with their software. While a scanner is not built for any software out of the box, they are configured per the software that is supposed to capture scanned data. Make sure the software used to configure the scanner can interact with the EHR or registry software.
- The optics and sensors: quality of an image is important for readability. While important, the number of pixels is not the only factor in determining image quality. Indeed the sensor will have an ability to deal with a certain number of pixels and, in very broad terms, the larger the number of pixels the better the definition of the image will be. The scanner will also make use of lenses. The focal length is not provided and some will be better at reading from a distance and others at reading close up. In very broad terms, reading very small bar codes is best done with a scanner with short focal distance, and reading larger codes is better done with a larger focal distance.
There are 3 basic types of scanners that can be used in an office:
- Corded: These are the most commonly used scanners. They are usually attached to a computer via USB or a serial port. They are also the least expensive. All data processing and decoding is done on the computer. Corded scanners get their power from the computer they are plugged in to, so they do not need a separate docking station. This may be convenient if you keep the scanner close to the nursing station where vaccines are prepared. This model can be replicated for as many work stations as nurses use in an office.
- Cordless (Bluetooth): These are also commonly used and are essentially the same as corded scanners, except that they communicate via a Bluetooth base station, which in turn is attached to a computer. They are especially useful in cases where the scanning needs to be performed in hard-to-reach areas. All data processing and decoding is done on the computer. They can cost up to twice the corded scanners for a comparable model. Cordless might be more convenient if scanning is taking place at the refrigerator or for practices that draw up vaccines in the same room prior to administration. A caution with Bluetooth devices: devices must be paired with an individual receiving computer and they don't switch based on which one happens to be closest. Most desktop computers do not have built in Bluetooth capabilities, either. There would need to be a pairing of a laptop/tablet (many of which come with Bluetooth capabilities embedded) or an external USB Bluetooth device would need to be purchased to plug into the desktop. If this were to work in an exam room, a scanner would need to be paired with a desktop or laptop for each exam room, or the medical staff would have to carry a scanner-laptop/tablet pair in addition to the vaccines.
- Wireless (Wi-fi) with in-built processing support: These scanners are mostly used in mobile application here access to a computer is impossible or not practical. Most devices have an in-built operating system and act like a computer themselves. The scanning, decoding and processing happens on the device itself. These can cost up four times the corded scanners. EHR vendors would also have to custom program the device for feedback to the EHR.
While there is a large variety to choose from, the ultimate choice will depend on what best suits a practice, based upon actual usage and cost.
Commercially available scanners can be used in conjunction with a configuration utility that can be used to specify data formatting rules. These utilities are vendor proprietary and can be used for the following functions:
- Specify data formatting rules
- Firmware upgrades
- Management of configurations
Data formatting rules can be configured to match the specific requirements of the providers' EHR system, or for that matter any system. It is important that the vendor has a mature and user friendly configuration utility that can be used by office staff at a later date. In the absence of this, the Provider staff will have to be dependent upon the vendor for their future needs.
The following information has been adapted with permission from the Automated Identification of Vaccine Product workflow produced by the Public Health Advisory Committee in Canada.
|Will vials be scanned at the point of vaccine delivery?|| |
|Who will be responsible for vial handling and scanning?|| |
|Will the data validate using an Electronic Health Record or registry?|| |
|Will you use the system for both inventory control and record keeping?|| |
|How will information be entered into the registry (eg, uploaded from EHR, uploaded separately)?|| |
|Who is involved in the vaccine administration workflow?|| |
|What happens during the workflow?|| |
|Why does the current workflow exist?|| |
|Is the current workflow linked to a barcode scanning system?|| |
|How is the current workflow performed? || |
|What are the gaps in the current workflow?|| |
|Where will scanners be made available in the office and to whom?|| |
|Will vaccine inventory be received as individual vials or in batches?|| |
|How will staff manage unidentifiable product?|| |
|Will staff be able to override the barcode entry?|| |
|What alternative method of vaccine entry will be provided if the scanner is not operative?|| |
Key Decisions: Scanner Selection
|Does the current hardware support scanning technology?|| |
|How will the scanner interface with the hardware?|| |
|Will the scanner be able to read the required barcode element size and resolution?|| |
|Will the scanner require external power supply?|| |
|What aiming support do users have for the scanner?|| |
|Will the scanner require any pre-calibration?|| |
|Will the scanner automatically read barcodes or will the user need to depress a key/trigger?|| |
|Will the scanner provide feedback of a successful scan?|| |
|Will the scanner enter a carriage return (confirmation) after scanning the barcode?|| |
|Will the scanner be portable or on a fixed cable?|| |
|Will the scanner be free standing or rest in a cradle?|| |
Key Decisions: Training and Support Materials
|How will practice procedures and office trainings be modified to integrate scanning procedures and information on scanner use?|| |
|How will immunization staff be trained on setting up the scanner for use?|| |
|How will scanning procedures and scanner use be demonstrated to system users?|| |
|How will immunization staff be trained to use the scanners?|| |
|What materials will support scanning in the immunization setting?|| |
list of 2D barcoded vaccines currently shipping. Click here for a PDF to the checklists above.