Documentation Dilemma: Tips for Maintaining Immunization Records
Federal rules are very specific.
Everybody knows how to document a shot, right? Wrong! Although it’s easy to document correctly, many clinicians simply don’t know how to do it properly. Or, they forget that the federal government has very specific rules about immunization documentation.1
By documentation, the federal government means the way you record that you administered an immunization and the way you inform patients about what vaccine(s) they received.2,3 Approximately one-fourth of immunization entries are incomplete.4 Additionally, vaccine abbreviations—DtaP, Tdap, DT, Td—are so similar, many clinicians inadvertently transpose letters, creating errors.5
Table 1 presents (1) some important points about vaccinations and immunization documentation and (2) tips on how to find documentation that may be saved in different places.
The 1986 National Childhood Vaccine Injury Act was enacted to reduce manufacturers’ potential liability from injury claims. It is basically a no-fault system to compensate the very few people who sustain injuries due to vaccines and to ensure that the US vaccine supply stays stable. It requires all clinicians who administer immunizations to do the following for specific vaccines (Table 2)7:
- Give the patient (or parent/legal representative of a minor) a copy of the relevant federal Vaccine Information Statement (VIS) for the vaccine they will receive.
- Record certain information about the vaccine(s) administered in the patient’s medical record or a permanent log.
- Document any adverse event(s) the patient experiences after vaccination, whether or not the clinician believes it is related to the vaccine, and submit the report to the Vaccine Adverse Event Reporting System (VAERS).8
Vaccine Information Statements
The Centers for Disease Control and Prevention (CDC) creates all VISs. The concise 1- to 2-page documents explain the vaccine’s benefits and risks in vocabulary that vaccine recipients should be able to understand. Many VISs are available in languages other than English; the CDC offers some VISs in 41 languages. When new products are approved, the CDC creates a VIS as soon as possible after the Advisory Committee on Immunization Practices (ACIP) makes recommendations. Clinicians can administer the new vaccine even if the VIS is unavailable; they should be sure to counsel patients about benefits and risks.7,9
Remind patients to save the VIS because it has information that may be useful later; for example, if they think they are having side effects. The astute pharmacist may note that the content of some VISs differs from the vaccine manufacturer’s complete prescribing information. The CDC uses ACIP’s recommendations, which occasionally differ from those made by the manufacturer, to develop these documents. Pharmacists will see the greatest difference in the adverse event (AE) section. The ACIP generally recognizes only AEs linked causally to the vaccine, while the FDA requires manufacturers to include all AEs associated with a vaccine during clinical trials, even if they were temporary.9
Clinicians must provide the most current version of the VIS to patients. The CDC updates VISs only when necessary, so some VISs have older dates. The CDC’s VIS website (www.cdc.gov/vaccines/hcp/vis/index.html) always has the most current version.7,9
VISs are not, as many people believe, informed consent documents. Patients do not need to sign them, and clinicians do not need to retain copies. Each state has its own laws about informed consent, however, so pharmacists need to be aware of, and stay current on, local requirements.9-11
Permanent Record, Please
Federal requirements mandate that clinicians document 5 things in their permanent records when they administer a vaccine3:
- The vaccine’s name and manufacturer
- The vaccine’s lot number and expiration date (necessary for public health surveillance and implementation of vaccine product recalls)
- The administration site
- Your name, address, title, and signature (electronic is acceptable)
- The VIS edition date and the date the patient or parent receives the VIS; each VIS now has a bar code that can be used by sites that have 2-dimensional bar-code readers
There are various ways to document immunizations. Paper records and electronic records are best when they include an immunization template (for examples, see www.immunize.org or call 651-647-9009) that can be printed and given to patients who need documentation or just so the patient has a record.10 In addition, consider providing or updating patients’ wallet-size cards, which they can carry with them; if patients don’t have personal immunization records, suggest that they start carrying them. The Immunization Action Coalition offers many free tools to help (1) immunizers improve their documentation and (2) patients keep track of their own immunizations.
Ms. Wick is a visiting professor at the University of Connecticut School of Pharmacy and a certified pharmacist immunizer.
- Immunization Action Coalition. Clinic resources. www.immunize.org/clinic/documenting-vaccination.asp. Accessed August 9, 2013.
- Immunization Action Coalition. It’s federal law! www.immunize.org/catg.d/p2027.pdf. Accessed August 9, 2013.
- O’Connor AC, Kennedy ED, Loomis RJ, et al. Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking. Vaccine. 201328;31:3179-3186.
- Centers for Disease Control and Prevention. VAERS vaccine lot information. National Center for Immunization and Respiratory Diseases, Atlanta, GA, 2011 [unpublished data].
- Wilton R, Pennisi AJ. Evaluating the accuracy of transcribed computer-stored immunization data. Pediatrics. 1994;94(part 1):902-906.
- Immunization Action Coalition. Tips for locating old immunization records. www.immunize.org/catg.d/p3065.pdf. Accessed August 9, 2013.
- National Vaccine Information Center. National childhood vaccine injury act of 1986. http://www.nvic.org/Vaccine-Laws/1986-Vaccine-Injury-Law.aspx. Accessed August 9, 2013.
- US Department of Health and Human Services. Vaccine adverse event reporting system (VAERS). http://vaers.hhs.gov/index. Accessed August 10, 2013.
- Centers for Disease Control and Prevention. VIS frequently asked questions. http://www.cdc.gov/vaccines/hcp/vis/about/vis-faqs.html. Accessed August 9, 2013.
- Salazar M, Stinson KE, Sillau SH, Good L, Newman LS. Web-based electronic health records improve data completeness and reduce medical discrepancies in employee vaccination programs. Infect Control Hosp Epidemiol. 2012;33:84-86.
- Centers for Disease Control and Prevention. Vaccine information statements. www.cdc.gov/vaccines/hcp/vis/index.html. Accessed August 9, 2013.