The Standards for Pediatric Immunization Practice
Does your child's health care provider meet the Standards?
In May 1992, responding to a recent resurgence of measles, the U.S. Public Health Service and a diverse group of medical and public health experts established the Standards for Pediatric Immunization Practices. These Standards, which were approved by the U.S. Public Health Service and endorsed by the American Academy of Pediatrics, represent the most desirable practices for all health care providers and immunization programs.
While addressed to health professionals, the Standards provide the public with guidelines on what should be expected of the providers and programs responsible for their child's immunization care. And while the language published in 1992 applies to childhood vaccinations, much of it applies to adult immunizations as well.
The full text follows, with an explanation of each standard, as adapted from the National Vaccine Advisory Committee's (NVAC's) discussions of the Standards. (1)
Ideally, immunizations should be given as part of comprehensive child health care. This is the ultimate goal toward which the nation must strive if all of America's children are to benefit from the best primary disease prevention our health care system has to offer.
Overall improvement in our primary care delivery system requires intensive effort and will take time. However, we should not wait for changes in this system before providing immunizations more effectively to our children. Current health care policies and practices in all settings result in the failure to deliver vaccines on schedule to many of our vulnerable preschool-aged children. This failure is due primarily to barriers that impeded vaccine delivery and to missed opportunities during clinic visits.
Changes in policies and practices can immediately improve coverage. The present system should be geared to "user-friendly," family-centered, culturally sensitive, and comprehensive primary health care that can provide rapid, efficient, and consumer-oriented services to the users, i.e., children and their parents. The failure to do so is evidenced by the recent resurgence of measles and measles-related childhood mortality, which may be an omen of other vaccine-preventable disease outbreaks.
Present childhood immunization practices must be changed if we wish to protect the nation's children and immunize 90% of two-year-olds by the year 2000.
The following standards for pediatric immunization practices address these issues. These standards are recommended for use by all health professionals in the public and private sector who administer vaccines to or manage immunization services for infants and children. These Standards represent the most desirable immunization practices which health providers should strive to achieve to the extent possible. By adopting these Standards, providers can begin to enhance and change their own policies and practices.
While not all providers will have the funds necessary to implement the Standards immediately, those providers and programs lacking the resources to implement the Standards fully should find them a useful tool in better delineating immunization needs and in obtaining additional resources in the future in order to achieve the Healthy People 2000 immunization objective.
Standard 1: Immunization services are readily available.
By readily available, NVAC meant that the times immunization services are provided should be in keeping with the schedules of today's working parents, as well as the needs of parents who are at home full- or part-time.
NVAC suggested non-traditional times, such as weekends, evenings, early mornings, and lunch-hours, as possibilities. NVAC also suggested integrating immunization services into days and hours when other child health services, such as the Special Supplemental Food Program for Women, Infants, and Children (WIC) are offered.
NVAC also recommended that providers should keep an adequate stock of vaccines on hand, to prevent missed immunizations or the need for return visits.
Standard 2: No barriers or unnecessary prerequisites to the receipt of vaccines exist.
NVAC viewed "by appointment only" systems as barriers to immunization in both public and private settings and suggested walk-in services with waiting times of no more than 30 minutes.
NVAC suggested that such services should be provided in conjunction with rapid and efficient screening (to assess the child's current health and vaccination status, for example) and should not be contingent on receiving other comprehensive health services. NVAC determined that, unless a child has symptoms of illness, or the visit is a combined-purpose visit, a physical examination is not required at the time of an immunization. It is sufficient for the provider to observe the child's general state of health, ask the parent or guardian if the child is well, and question the parent or guardian about possible contraindications (reasons why the child should not be immunized).
Since every child needs consistent health care, parents who bring their child for "walk-in" immunization services should be counseled about the need for a personal primary care provider and should be given a referral to such a provider. In public clinics, immunizations should be provided according to a schedule (standing orders), rather than depending on individual written orders or referrals. This approach sidesteps the possibility of records being misplaced or immunization anniversaries being overlooked.
Standard 3: Immunization services are available free or for a minimal fee.
No child should miss immunizations because the parents cannot afford the fee.
For this reason, public clinics holding federal contracts for provision of immunizations must post a sign indicating that no one will be denied immunization services because of inability to pay. NVAC recommended that fees in both the public and the private sector should be reasonable.
Standard 4: Providers utilize all clinical encounters to screen and, when indicated, immunize children.
Every health care worker who sees your child should be alert to your child's immunization status, even in an emergency room setting or the office of a specialist.
If the immunizations are not up-to-date, immunization should be made available to your child during that visit or you should be referred back to the primary provider for immunization services.
Standard 5: Providers educate parents and guardians about immunization in general terms.
NVAC raised concerns not only about the need for information, but also that information should be presented in terms you can understand, including in another language, if necessary.
The provider should discuss with you the reasons why immunizations are so important, the diseases they prevent, the recommended immunization schedules, and why it's important for the immunizations to be given at the right ages. Also, your provider should instruct you to bring your child's immunization record to each visit, a step that will prevent both missed immunizations and unnecessary immunizations.
You should have an opportunity to discuss questions and raise any concerns, and your provider should have materials that you can take home to read and refresh your understanding of what was said.
Standard 6: Providers question parents or guardians about contraindications and, before immunizing a child, inform them in specific terms about the risks and benefits of the immunizations their child is to receive.
According to NVAC, you should be asked questions to determine (1) whether your child has ever had an adverse event in connection with an immunization, and (2) whether your child has any conditions or circumstances that indicate that immunization should be withheld or delayed (for example, "Has your child had any fever in the past few days?").
You have a right to know about the benefits as well as the risks of vaccines. For this reason, the U.S. federal government requires both public and private health-care providers to give you printed materials, called Vaccine Information Statements, regarding measles, mumps, rubella, diphtheria, tetanus, pertussis (whooping cough), and polio vaccinations, when your child will be having any of these. Furthermore, your health-care provider should review these statements with you.
Another type of printed material, called Important Information Statements, is required in public health clinics, and recommended in private settings, to inform you regarding other vaccinations, such as hepatitis B or Haemophilus influenzae type b. All of these materials should be current and available in appropriate languages. Your provider should also ask you if you have read the materials and whether you have any questions about the information you have been given.
Standard 7: Providers follow only true contraindications.
Your provider should exercise informed, good judgment about what constitutes a medically sound reason for withholding an immunization, using the guidelines published by the Advisory Committee on Immunization Practices, the Committee on Infectious Diseases of the American Academy of Pediatrics, and the American Academy of Family Physicians.
Standard 8: Providers administer simultaneously all vaccine doses for which a child is eligible at the time of each visit.
Available evidence suggests that simultaneous administration of childhood immunizations is safe and effective.
Measles, mumps, rubella vaccine should always be used in combination form for childhood immunizations. Simultaneous administration or combined-form vaccines reduce the number of visits or shots that are needed and help to ensure that your child completes all needed vaccinations.
Standard 9: Providers use accurate and complete recording procedures.
This standard specifies the orderly approach that should be taken to ensure accurate record-keeping, so that needed vaccinations will not be missed and unnecessary vaccinations will not be given.
Immunization providers are required by law to record what vaccine was given, the date the vaccine was given (month, day, year), the name of the manufacturer of the vaccine, the lot number, the signature and title of the person who gave the vaccine, and the address where the vaccine was given. NVAC believes that in addition, the parent or guardian should be given a permanent record to keep and carry to office visits for updates. If this record is lost, a replacement with complete immunization data should be provided.
Providers should verify vaccination histories from previous providers whenever possible, and if the provider of an immunization is not the primary care physician, a report of vaccines given should be sent to the primary care provider.
Standard 10: Providers co-schedule immunization appointments in conjunction with appointments for other child health services.
This standard recommends efficient use of the parent's and child's time, as well as an opportunity to provide immunizations that might otherwise be missed.
Standard 11: Providers report adverse events following immunization promptly, accurately, and completely.
You, as a parent, should be encouraged to report any adverse events that are or appear to be associated with a vaccination.
In turn, your health-care provider should record the event fully in the medical record and promptly report any such events that are clinically significant to the national Vaccine Adverse Event Reporting System (VAERS), regardless of whether the event is believed to be related to the vaccine. The toll-free telephone number for VAERS is 1-800-822-7967.(2)
Standard 12: Providers operate a tracking system.
Your health-care provider is responsible for keeping accurate, up-to-date records of your child's immunizations and for alerting you when immunizations are due.
Computer systems make this easier, but providers who have not converted their records to computer storage should maintain a manual system. Children who are at high risk for not completing their immunization series should be given special attention in the tracking system.
Standard 13: Providers adhere to appropriate procedures for vaccine management.
To keep their potency, vaccines must be handled and stored appropriately, according to the directions in the manufacturer's package inserts.
A good sign in any medical office is that one qualified individual is charged with responsibility for monitoring the vaccine supplies: how many are on hand, where they are stored, how they are handled (e.g., are they returned to the refrigerator promptly?), and the expiration dates that are stamped on the bottles.
Standard 14: Providers conduct semi-annual audits to assess immunization coverage levels and to review immunization records in the patient populations they serve.
Audits are an essential and routine measure in any type of health care.
Hospitals audit how many beds are in use in a given period, the type and number of surgical procedures performed, how many patients died while in the hospital and why, the types of medications prescribed, and the charges for services. Clinics perform similar audits.
Individual practitioners may be less inclined to do in-depth audits, but a random sample of records can reveal the percent of children who are up-to-date by their second birthday, identify missed opportunities for simultaneous immunization, and assess the quality of the records that are being kept. These are vital steps to assure quality care for your child. How do you know if your provider performs such audits? Ask the office nurse.
Standard 15: Providers maintain up-to-date, easily retrievable medical protocols at all locations where vaccines are administered.
A medical protocol is a detailed description of how a procedure will be done. Today's medical technology is changing at unprecedented speed, so health-care providers cannot rely entirely on memory or previous experience for how to use medical equipment or medications. They must have technical information at hand, either in a computer database or in printed "handbook" form that can be used by both experienced and new staff.
If you see your physician, nurse, or pharmacist checking for a dosage, the name of a medication, or other information, interpret it as a sign that this health professional is committed to accuracy, safety, and state-of-the-art care.
Standard 16: Providers operate with patient-oriented and community-based approaches.
Health-care workers spend the majority of their days indoors, working long and intensely focused days. Sometimes they become so attached to their routines that any suggestion that things should be done differently is viewed as an affront.
Nevertheless, if your provider is not asking you if things are going well, don't hesitate to speak up. If you are finding it difficult to bring your child in during the day for immunizations, say so. If the waits are so long that your child is becoming fussy and you are on the verge of walking out, your provider needs to know this.
Under this standard, providers in the public sector are especially obligated to look to the community to be sure that their services are reaching everyone, not just the people who come in routinely. They should be using a variety of methods to inform the public about immunizations and should be publicizing the places and times that these are available.
Standard 17: Vaccines are administered by properly trained individuals.
This does not mean that only a physician or nurse should administer vaccinations. In fact, specifying so may create barriers to immunization.
In emergency circumstances – for example, after a natural disaster – the need for typhoid or other immunizations may suddenly be in the thousands per day, and available medical personnel would not be able to meet this need. In the fall, the demand for flu shots can be very high, overwhelming normal office routines and resulting in long, tedious waits. In low-income neighborhoods, the demand for no-cost publicly funded immunizations may be high.
The tendency for meeting these needs today is to use non-traditional sites, even grocery stores, and to use non-traditional providers to administer vaccinations. In many states, pharmacists can routinely give immunizations. Few people would think of their dentist as an immunization provider, but why not? In each of these cases, immunizations can be safe as long as the people giving the vaccines have been appropriately trained and all other protocols, such as using sterile methods and keeping accurate records, are kept.
Standard 18: Providers receive ongoing education and training on current immunization recommendations.
Vaccines, immunization techniques, and vaccination schedules change periodically. For example, the recommended method of administering polio vaccine was recently changed from oral polio vaccine to a series of injections using the inactivated form of the vaccine.
The change is important because it establishes a safer method. Your health-care provider should be up-to-date on this and other changes in immunization recommendations.
Whom to call if you have specific vaccine safety questions
For additional information on your vaccine safety questions, call:
CDC/National Immunization Program Resource Center
1. National Immunization Program. Standards for Pediatric Immunization Practices [monograph]. 7th printing. Washington, DC: Department of Health and Human Services, United States Public Health Service, Centers for Disease Control and Prevention, February 1996.
2. Food and Drug Administration. Vaccine adverse event reporting system [brochure]. Washington, DC: FDA, no date.