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Documenting Vaccination

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Documenting Vaccination
Where can I find a list of vaccines currently licensed for use in the U.S.?
CDC maintains a sortable list of vaccine names at www.cdc.gov/vaccines/about/terms/USVaccines.html.
When we are giving multiple injections in a limb, what is the best way to accurately document the injection site?
One way to handle this is to indicate if the vaccination was given either in the "upper" or "lower" portion of the injection area selected (e.g., DTaP: right thigh, upper; Hib: right thigh, lower; or PCV13: left thigh, upper; HepB: left thigh, lower). It is helpful if everyone in your office or clinic uses the same sites for each vaccine. Use of a standardized site map can facilitate this. Here are some helpful site maps for different ages so you can record where shots were given:
For infants and toddlers: www.eziz.org/assets/docs/IMM-718.pdf
For adolescents: www.aimtoolkit.org/pdf/7_Givingallthedoses_adolescent_013113.pdf
For adults: www.eziz.org/assets/docs/IMM-718A.pdf
We frequently see patients, such as immigrants who do not have records of past vaccination or who insist they or their children are up to date. Should we accept their undocumented vaccination history?
Vaccination providers frequently encounter people who do not have adequate documentation of vaccinations. Providers should only accept written, dated records as evidence of vaccination. With the exception of influenza vaccine and pneumococcal polysaccharide vaccine, self-reported doses of vaccine without written documentation should not be accepted. An attempt to locate missing records should be made whenever possible by contacting previous healthcare providers, reviewing state or local immunization information systems, and searching for a personally held record. However, if records cannot be located or will definitely not be available anywhere because of the patient's circumstances, children without adequate documentation should be considered susceptible and should be started on the age-appropriate vaccination schedule. Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, or hepatitis A,). Helpful guidance about which vaccines may have been previously recommended outside the U.S. is available at www.who.int/immunization/policy/immunization_tables/en.
In general, although it is not ideal, receiving extra doses of vaccine poses no medical problem. Receiving excessive doses of tetanus toxoid (DTaP, DT, Tdap, or Td) can increase the risk of a local adverse reaction, however. For details, consult the ACIP General Recommendations on Immunization, available at www.cdc.gov/mmwr/pdf/rr/rr6002.pdf, page 10
We sometimes encounter patients with foreign vaccination records. We suspect that some of these records are not valid. What should we do?
If a provider suspects an invalid vaccination, including those from persons vaccinated outside the U.S., one of two approaches can be taken. Repeating the vaccinations is an acceptable option. Doing so is generally safe and avoids the need to obtain and interpret serologic tests. If avoiding unnecessary injections is desired, judicious use of serologic testing might be helpful in determining which immunizations are needed. This may be particularly helpful in determining tetanus and diphtheria antitoxin levels for children whose records indicate 3 or more doses of DTP or DTaP. This issue is discussed in the ACIP General Recommendations on Immunization, available at www.cdc.gov/mmwr/pdf/rr/rr6002.pdf, page 10 and pages 27-29.
Where can I find names of vaccines used outside the U.S.?
Appendix B of the CDC publication Epidemiology and Prevention of Vaccine-Preventable Diseases ("The Pink Book") contains a list of vaccines used outside the U.S. You'll find Appendix B at www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/foreign-products-tables.pdf.
Since the Health Insurance Portability and Accountability Act (HIPAA) went into effect, we are unsure if we can share immunization information on our pediatric patients with staff in schools or daycare facilities.
Healthcare providers (or other covered entities) may share immunization information with schools or daycare facilities, without authorization, if permitted or required by state law. These state laws would not be preempted by the HIPAA Privacy Rule [45 CFR 160.203(c)].
If a patient or parent refuses recommended vaccinations, is it necessary for them to sign a refusal form, or is the provider's documentation sufficient?
There is no federal law requiring such documentation. Several major medical organizations, including the American Academy of Pediatrics, have stated that healthcare providers may decide it is in their best interest to formally document a parent's refusal to accept vaccination for their (minor) child. To read a discussion on this topic and to access a prototype refusal form, see "Decision to not vaccinate my child" that can be accessed at www.immunize.org/catg.d/p4059.pdf.
How can I find out if our state or locality has an Immunization Information System (IIS) in which I might participate?
Significant progress has been made in the development of IISs. Much of this information is available from the American Immunization Registry Association (AIRA) at www.immregistries.org. AIRA provides a forum through which IIS programs, as well as interested organizations, individuals, and communities combine efforts and share knowledge that promotes IIS activities as a resource for both IISs and immunization programs. To view the current status of IIS development in your state, go to AIRA's Registry Profiles and click on a state on the map to bring up a list of IISs in that state. Clicking on an IIS will display information about that IIS, including programmatic and technical contact information. If you would like to participate, contact your state health department immunization program. Phone numbers are available at www.immunize.org/coordinators.
If my state has an Immunization Information System (IIS, or registry) do I still need to give the patient a vaccine record card?
Yes. Patient-held cards are an extremely important part of a person's medical history. The person may move to an area without a registry, and the personal record may be the only vaccination record available. In addition, even within a state, all healthcare providers may not participate in the registry, and the personal record card would be needed.
Please explain the federal requirements for all healthcare providers that administer vaccines under the National Childhood Vaccine Injury Act.
The National Childhood Vaccine Injury Act (NCVIA), enacted in 1986, set forth 3 basic requirements for all vaccination providers, which are:
Providers must give the patient (or parent/legal representative of a minor) a copy of the relevant federal "Vaccine Information Statement" (VIS) for the vaccine they are about to receive.
Providers must record certain information about the vaccine(s) administered in the patient's medical record or a permanent office log.
Providers must document any adverse event following the vaccination that the patient experiences and that becomes known to the provider, whether or not it is felt to be caused by the vaccine, and submit the report to the Vaccine Adverse Event Reporting System (VAERS).
What do we legally need to record when giving an immunization to a patient?
It is important to know the federal requirements for documenting the vaccines administered to your patients. The requirements are defined in the National Childhood Vaccine Injury Act enacted in 1986. The law applies to all routinely recommended childhood vaccines, regardless of the age of the patient receiving the vaccines. The only vaccines not included in this law are pneumococcal polysaccharide, zoster, and certain infrequently used vaccines, such as rabies and Japanese encephalitis.
The following information must be documented on the patient's paper or electronic medical record or on a permanent office log:
1. The vaccine manufacturer.
2.   The lot number of the vaccine.
3.   The date the vaccine is administered.
4.   The name, office address, and title of the healthcare provider administering the vaccine.
5.   The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
6.   The date the VIS is given to the patient, parent, or guardian.
The federally required information should be both permanent and accessible.
Federal law does not require a parent, patient, or guardian to sign a consent form in order to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient under federal law.
Which vaccines are covered by NCVIA?
NCVIA requirements apply to diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), varicella, seasonal influenza (inactivated and live attenuated), pneumococcal conjugate, meningococcal, rotavirus, and human papillomavirus (HPV) vaccine.
When and to whom is it required to give Vaccine Information Statements (VISs)?
The National Childhood Vaccine Injury Act requires that a VIS must be given to parents, legal representatives, or adult patients before administering the vaccine. A VIS must be provided prior to each dose, not just the first dose. Providers should be sure they are using the most current version of each VIS. Current VISs and their dates are available from on the CDC's website at www.cdc.gov/vaccines/hcp/vis/index.html and from IAC's website at www.immunize.org/vis.
Where can I get instructions on how, why, and when to use the federally-mandated VISs?
Instructions on the use of VISs and many additional items are available on the CDC website at www.cdc.gov/vaccines/hcp/vis/index.html or from your state immunization program. You can also visit IAC's website at www.immunize.org/vis for links to many important documents about the use of VISs.
When are VISs released for new vaccines?
An interim VIS can sometimes be released soon after licensure of the vaccine or after the official vote by ACIP is taken. The interim VIS is not replaced with a final version until the ACIP recommendations have been published and the new VIS has been developed according to legally-mandated procedures.
Is it required to use a VIS in an emergency room when we give Td/Tdap to a patient?
Yes. The National Childhood Vaccine Injury Act requires that a VIS be given to people of any age before they receive a dose of any vaccine included in the Act. Tetanus and diphtheria toxoids (and pertussis vaccine) are included in the Act. If the patient is unaccompanied and unable to clearly read and understand the information in the VIS (e.g., the patient is unconscious), this should be noted in the patient's chart.
Does the federal law that requires providing patients with VISs apply when administering influenza vaccine to employees and volunteers in hospitals or other workplaces?
Yes. Employees and volunteers are considered patients, and you need to provide them with a VIS. If a vaccine is covered under the National Childhood Vaccine Injury Act—and almost all vaccines routinely administered to adults are (with the exception of PPSV and zoster)—it is mandatory under federal law to give the VIS for that vaccine to the patient. So when you give influenza vaccine to employees and staff, you are required by law to provide them with a VIS.
You can find more details about the requirements for using VISs at www.cdc.gov/vaccines/hcp/vis/about/required-use-instructions.html. For VISs in multiple languages, go to www.immunize.org/vis.
Our large pediatric practice is struggling with the requirement to provide VISs to the parents of every child we vaccinate. We would like to create a re-usable packet of laminated VIS sheets (fastened together on a ring). We plan to place a packet in each exam room for parents to read prior to vaccine administration. On the bottom of each sheet would be a statement, "If you would like a copy of this sheet to take home, please ask our staff." This will ensure that parents are given the VIS sheets to read prior to vaccine administration. It will also help save paper. Our experience is that many parents throw out the VIS documents or leave them behind in the waiting room. Is this an acceptable procedure?
Many clinicians are looking for ways to reduce paper use. Your solution will meet the spirit of the federal law, as long as you make sure to encourage the patient (or parent) to take home a paper copy of the VIS and to refer to it if needed (e.g., if they need to know what to do if there is an adverse event or how to contact VAERS). Patients can also download VISs onto mobile devices. For more information about this technology, go to www.cdc.gov/vaccines/hcp/vis/mobile.html.
We operate an acute care hospital and commonly give vaccinations to our employees and patients. Are we required to use VISs, or does that apply only to patients seen in outpatient settings?
VISs must be given to all people, including adults, before administering HPV, Td, Tdap, MMR, varicella, hepatitis A, hepatitis B, meningococcal, influenza, or polio vaccine. Current VISs are available from the CDC's website at www.cdc.gov/vaccines/hcp/vis/index.html and from the Immunization Action Coalition's (IAC) website at www.immunize.org/vis. You'll also find many VIS translations on IAC's website at www.immunize.org/vis.
When using VISs and providing vaccines, is a parent/guardian signature required?
No. There is no federal requirement for signed consent for any dose of vaccine. The federal requirement is to provide all adult patients or parents/legal representatives of minor children with the appropriate VIS for each dose of vaccine administered. Federal law also requires that you record the date you gave the VIS to the patient or minor child's parent/legal representative and the edition date of the VIS, among other items, in the patient's medical record. Some clinics, agencies, and/or state immunization programs may have requirements for signatures. Contact information for your state health department is available at www.immunize.org/coordinators.
Where can I get VISs for some of the newer combination vaccines?
CDC currently has no plans to develop VISs for Pediarix, Comvax, Twinrix, Kinrix, or Pentacel. When administering these combination vaccines, use the VISs for all component vaccines. For certain combination vaccines given to children, you can use the multi-vaccine VIS and check the appropriate box(es), just as you would if you were administering the individual vaccines. If the multi-vaccine VIS is unavailable, you should use the individual vaccine VISs. A VIS was developed for MMRV vaccine because of its unique adverse reaction profile.
It seems CDC is changing the format of VISs. Do we have to throw our old supply away and use the new ones?
Not necessarily. CDC is in the process of re-releasing all VISs in a slightly modified format. The modified VISs have a consistent look and use consistent language in the sections common to all VISs. Modified VISs will not necessarily be new, but may simply be redesigned versions of existing VISs and have the same edition dates as existing VISs. Providers do not need to discard their existing VIS stocks when nothing but the VIS format has been changed. CDC posts information on its website to alert healthcare providers when the older version of a VIS should not be used. This information is available on CDC's web section titled “What's New with VISs”, available at www.cdc.gov/vaccines/hcp/vis/what-is-new.html.
Why does CDC include 2D barcodes on VISs now?
As part of a modernization initiative, CDC began adding barcodes to VISs in 2012. The addition of the barcode is intended primarily to help immunization providers save time by allowing them to scan certain required information about the VIS (for example, the name and edition date of the VIS) into an electronic medical record, immunization information system, or other electronic database. Scanning the barcode instead of manually recording the information is optional at this time but can be advantageous to the practice.
Using 2D barcodes requires a 2D barcode scanner and software that is programmed to accept and process data contained in the VIS barcodes. Providers may continue to use any VISs they printed before CDC started adding barcodes as long as the VIS content is otherwise the same. For more information about barcodes and scanning, visit www.cdc.gov/vaccines/hcp/vis/barcodes.html.
Where can I get foreign language VISs?
CDC publishes VISs in English only; all translations have been developed by others. To access all currently available VISs in more than 35 languages and links to some alternative formats (audio/video), go to IAC's website at www.immunize.org/vis.
This page was reviewed on July 31, 2014
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