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National Immunization Survey

Frequently Asked Questions for the National Immunization Survey

 

Parents and Guardians

 

What is the purpose of the survey?

The purpose of the National Immunization Survey is to monitor the immunizations of children across the country. It has been discovered that many children are not receiving their required immunizations, and this could potentially lead to the re-emergence of many serious diseases.

Who uses this information?

The National Center for Health Statistics and the National Center for Immunizations and Respiratory Diseases (both agencies are part of the Centers for Disease Control and Prevention) will use the results of the study to help improve children's health. By monitoring immunization across the country, the Centers for Disease Control and Prevention is able to assess the extent to which the country, States, and certain metropolitan areas are reaching the immunization goals of the Childhood Immunization Initiative. The results of the study do not involve any personal identifying information from survey participants. They are available only at the metropolitan, State, or national level.

How are telephone numbers selected?

A computer randomly generates the telephone numbers that are used for the study's telephone survey.  No person or organization provides the study with any telephone numbers. (The survey involves conducting interviews with people across the entire country.)

Is there a letter that explains the study?

Most households selected for the study receive a letter in advance [PDF - 47 KB] that explains the purpose of the study. This letter is from Charles Rothwell, Acting Director of the National Center for Health Statistics. Not all selected households receive a letter in advance, however, because the study does not have the mailing address for all telephone numbers selected for the study. You may contact the study's telephone survey researchers at 1-877-267-8154 to have a letter sent to your home.

What is the legal authorization for the study?

The study is being conducted on behalf of the U.S. Centers for Disease Control and Prevention, and it is authorized by the Public Health Service Act [Sections 306 & 2102(a)(7)]. You may call our toll-free number 1-800-223-8118 to verify the legitimacy of this survey and obtain more information. Please mention protocol #2013-01.

How is confidentiality of information assured?

Confidentiality is mandated by law. Findings will be issued only in summary form and U.S. law requires that the name of study participants not be associated with any answers. The federal laws that require all information we collect to be held in strict confidence are the Privacy Act of 1974, Section 308(d) of the Public Health Service Act [42 U.S.C. 242m(d)], and the Confidential Information Protection and Statistical Efficiency Act (PL 107-347). If any federal employee, contractor, or agent gives out confidential information not authorized by law, he or she can be fired, fined, and/or imprisoned.

Why does the study request information from the children's medical provider?

We have discovered that vaccination information from doctors and clinics tends to be the most up-to-date and comprehensive and that the quality of the study's results is much improved by combining the information given by households with that given by medical providers. It is important that we obtain the most reliable information possible about children's vaccinations so that we can provide the public with reliable estimates.

Will the medical provider give a child's full medical history to the CDC?

No. With the permission of a parent or legal guardian, we send a request form, along with a record of the parent or guardian's consent, to the child's doctor or clinic. The request form asks specifically about the vaccination records only, and we do not expect providers to give any other information.

Once immunization data have been collected, identifying information is no longer necessary or used. The Centers for Disease Control and Prevention assure you that any names of children, as well as any names of doctors or clinics, will not be used in any study results.

What information is available about immunizations and about places that provide immunizations?

For more information regarding vaccinations or the phone number of a doctor or clinic near you, please call the Centers for Disease Control and Prevention Information Contact Center at (800) 232-4636 (1-800-CDC-INFO) and select option 1. For more information about immunization, please visit the Web site for the National Center for Immunizations and Respiratory Diseases.

 

Vaccination Providers

 

Cover letter [PDF - 76 KB]  and questionnaire for vaccination providers [PDF - 263 KB] requested to participate in the National Immunization Survey Provider Study.  You can also view the NIS Documentation Notice for HIPAA Accounting [PDF - 14 KB] here.

 

Why is the National Immunization Survey Requestion Information from Providers?

We have discovered that sources of vaccination information from doctors and clinics are the most up-to-date and comprehensive and that the quality of the study's results is much improved by combining the information given by households with that given by these medical providers.  It is important that we obtain the most reliable information possible about children's vaccinations so that we can provide the public with reliable estimates.

Does the Privacy Rule allow me to participate in the NIS?

The Privacy Rule permits you to make disclosures of protected health information without signed patient authorization for public health purposes and for research that has been approved by an Institutional Review Board (IRB).  This survey meets both of those criteria.

Does the NIS have any documentation of patient authorization?

While not required by the Privacy Rule, a parent or guardian has given verbal authorization for the release of the child’s immunization history to us.  Documentation of this verbal consent is provided to you with the request for immunization data.

Am I required to comply with the HIPAA Privacy Rule?

Health care providers who transmit financial and administrative health information electronically must comply with the Rule as of April 14, 2003.  For example, if you submit claims electronically, you would be required to comply with the Rule.

What is protected health information?

Protected health information includes all medical records and other individually identifiable information used or disclosed by an entity subject to the Privacy Rule.  This would include directly identifiable information such as patient names, and other information such as social security numbers that could be used to identify an individual.

What do I have to do to participate and comply with the Privacy Rule?

There are several things that would ensure that you comply with the Rule when participating in the survey.  First, the privacy notice that you provide to your patients must indicate that patient information may be disclosed for research or public health purposes.   Many of the model notices that have been developed and made available by professional associations provide for this.

Also, we have provided and made available on our website the material that you may need to verify, under the requirements of the Privacy Rule, that you are allowed to disclose to CDC the information requested as part of this survey.  This includes the authority under which CDC is collecting this information and that the information being collected is the minimum necessary. Please see: http://www.cdc.gov/vaccines

Finally, you will need to keep track of disclosures made for this survey.  We will give you a document that contains the information that you need to keep track of the disclosures.

Is there any other information that I need to assess to ensure that my disclosure is authorized under the Privacy Rule?

No. The letter that you received requesting that you participate in this survey is from Rear Admiral, United States Public Health Service, Dr. Anne Schuchat, M.D. Dr. Schuchat is the Director of the National Center for Immunization and Respiratory Diseases, which is part of CDC. The Privacy Rule specifies that you are allowed to disclose information requested for public health purposes to public health agencies such as CDC without patient authorization. The Rule also states that for research projects you may rely on documentation that we have provided indicating that an Institutional Review Board (IRB) has approved a waiver to allow for disclosure with verbal authorization from a parent or legal guardian of the information we are requesting in this survey.

What demonstrates that you are a public health authority?

The survey is sponsored by the National Center for Immunizations and Respiratory Diseases and the National Center for Health Statistics, agencies of the CDC.  CDC is a public health authority whose mission is to protect the health of the public.  The letter that we sent asking you to participate was sent on official CDC letterhead and described our legislative authority to conduct this survey.

Why do I have to account for these disclosures?

Under the Privacy Rule, patients have a right to an accounting of disclosures that have been made of their identifiable information for various purposes, including disclosures for public health and research purposes. We have provided you with a form to account for the disclosures made as part of this survey.

Do I need to worry about whether this is the minimum necessary information for the purposes of the project?

No. The Privacy Rule specifies that in providing information to public agencies, such as CDC, you may rely on our representation that the request constitutes the minimum necessary information required.  This issue is also considered as part of the Institutional Review Board (IRB) approval process, and the Privacy Rule specifies that you may rely on the documentation of IRB approval that the information requested is the minimum necessary for the research purpose.

Do I have to have an Institutional Review Board (IRB) review this research project?

No. For research projects, only one IRB must review the project and CDC’s IRB, know as the Research Ethics Review Board, ERB, (which has the authority to review such projects under the Regulations for the Protection of Human Subjects) has done so.  We have a document that indicates that a waiver has been approved by an IRB for this survey, and contains the documentation that is required by the Privacy Rule.  If you desire, your IRB may review the project as well.

What if I want my Institutional Review Board (IRB) to review this project?

Your IRB could verify that the documentation we have provided adheres to the requirements of the Privacy Rule.

Where can I find the requirements of the Privacy Rule?

HIPAA guidelines are available at the following website: http://www.hhs.gov/ocr/hipaa/

The following parts of the rule were referred to above:

  • Disclosures without patient authorization – 45 CFR 164.512
  • Disclosures for public health activities – 45 CFR 164.512(b) 
  • Disclosures for research purposes – 45 CFR 164.512(i)
  • Verification requirements – 45 CFR 164.514(h)
  • Privacy notice – 45 CFR 164.520
  • Accounting of disclosures – 45 CFR 164.528
  • Minimum necessary requirements – 45 CFR 164.502(b) and 45 CFR 164.514(d)

The following files may also be useful:

Under what legal authority do you collect this information?

This study is authorized by Section 306 of the Public Health Service Act and the National Childhood Vaccine Injury Act of 1986. Through the partnership with the National Center for Health Statistics, the information you supply will be treated confidentially and used for statistical purposes only, as specified by law in Section 308(d) of the Public Health Service Act and the Confidential Information Protection and Statistical Efficiency Act. Information that could identify you, your practice, your facility, the child, or the child's family will not be released. Although your participation is voluntary, we hope that you will choose to participate.

How do I return an immunization history questionnaire?

A pre-paid, addressed envelope was included in the packet of materials along with the request for information about the child’s immunizations. If you do not have the envelope, the address is:

NORC at the University of Chicago
National Immunization Survey
1 North State Street, FL 16
Chicago, IL  60602

If it is more convenient you may fax the information to our toll-free number: 1-866-324-8659

Is it necessary to fill out the entire form?

If you prefer, you may attach a photocopy of the child’s immunization history to the questionnaire and just complete the items on the first page.

Is there someone I can talk with about the NIS provider study?

If you have any questions or comments about the materials being requested, please call 1-800-817-4316. If you would like additional information about the National Immunization Survey, please call Ms. Marcie Cynamon at (301) 458-4174, with the National Center for Health Statistics.  Your participation in the National Immunization Survey Provider Record Check Study is greatly appreciated.

What do I do if this child is not my patient or if I have no immunization records for this child?

The first item on the front page of the questionnaire (see below) allows you to indicate this. Please check the appropriate option and return the form so that we do not send you a second request for the information.

1. Which of the following best describes your immunization records for this child?

[] You have all or partial immunization records for this child.
[] This facility gives immunizations only at birth (hospital).
[] Other – Explain
[] You have provided care to this child, but do not have immunization records.
[] You have no record of providing care to this child.

 

Frequently Asked Questions by Parents and Guardians (NIS Teen)

 

What is the purpose of the survey?

Many adolescents are not receiving all of the recommended immunizations. By monitoring and reporting on national immunization rates, the public health agencies in your area will have the information necessary to help prevent outbreaks of many serious diseases.

New vaccines have become available and are recommended for all adolescents. Immunization has the potential to protect not only the health of adolescents, but their friends, families, and communities.

Who uses this information?

The National Center for Immunizations and Respiratory Diseases and the National Center for Health Statistics (both part of the Centers for Disease Control and Prevention) will use the results of the study to help improve the health and well-being of adolescents aged 13 through 17. By monitoring immunizations across the country, the Centers for Disease Control and Prevention are able to assess the extent to which the country is reaching immunization goals for this population. No personal identifying information from survey participants will be released or published.

How are telephone numbers selected?

A computer randomly generates the telephone numbers that are used for the study's telephone survey. The NIS-Teen conducts interviews with people across the entire country.

Is there a letter that explains the study?

Most households selected for the study receive a letter in advance [PDF - 47 KB] that explains the purpose of the study. This letter is from Dr. Edward J. Sondik, Director of the National Center for Health Statistics. Not all selected households receive a letter in advance, because the study does not have the mailing address for all telephone numbers selected. You may view the letter or contact the study's telephone survey researchers at 1-877-267-8154 to have a letter sent to your home or to ask us questions about the survey.

What is the legal authorization for the study?

The study, which is conducted on behalf of the U.S. Centers for Disease Control and Prevention, is authorized by the Public Health Service Act [Sections 306 & 2102(a)(7)]. You may call our toll-free number 1-800-223-8118 to verify the legitimacy of this survey and obtain more information. Please mention protocol #2013-01.

How is confidentiality of information assured?

Confidentiality is mandated by law. Findings will be issued only in summary form and U.S. law requires that the name of study participants not be associated with any answers. The federal laws that require all information we collect to be held in strict confidence are the Privacy Act of 1974, Section 308(d) of the Public Health Service Act [42 U.S.C. 242m(d)], and the Confidential Information Protection and Statistical Efficiency Act (PL 107-347). If any federal employee, contractor, or agent gives out confidential information not authorized by law, he or she can be fired, fined, and/or imprisoned.

What information is available about immunizations and about places that provide immunizations?

For more information regarding vaccinations or the phone number of a doctor or clinic near you, please call the Centers for Disease Control and Prevention Information Contact Center at 1-800-232-4636 (1-800-CDC-INFO) and select option 1. For more information about immunization, please visit the web site for the National Center for Immunizations and Respiratory Diseases. National Center for Immunizations And Respiratory Diseases.

 

Frequently Asked Questions by Vaccination Providers (NIS Teen)

 

Cover letter [PDF - 71 KB]  and the questionnaire for vaccination providers [PDF - 93 KB] requested to participate in the National Immunization Survey Provider Study.  You can also view the NIS Documentation Notice for HIPAA Accounting [PDF - 14 KB] here.

 

Why is the National Immunization Survey Teen requesting information from providers?

We have discovered that sources of vaccination information from doctors and clinics are the most up-to-date and comprehensive and that the quality of the study's results is much improved by combining the information given by households with that given by these medical providers. It is important that we obtain the most reliable information possible about adolescents’ vaccinations so that we can provide the public with reliable estimates.

Does the Privacy Rule allow me to participate in the NIS-Teen?

The Privacy Rule permits you to make disclosures of protected health information without signed patient authorization for public health purposes and for research that has been approved by an Institutional Review Board (IRB). This survey meets both of those criteria.

Does the NIS-Teen have any documentation of patient authorization?

While not required by the Privacy Rule, a parent or guardian has given verbal authorization for the release of the adolescent’s immunization history to us. Documentation of this verbal consent is provided to you with the request for immunization data.

Am I required to comply with the HIPAA Privacy Rule?

Health care providers who transmit financial and administrative health information electronically must comply with the Rule as of April 14, 2003. For example, if you submit claims electronically, you would be required to comply with the Rule.

What is protected health information?

Protected health information includes all medical records and other individually identifiable information used or disclosed by an entity subject to the Privacy Rule.  This would include directly identifiable information such as patient names, and other information such as social security numbers that could be used to identify an individual.

What do I have to do to participate and comply with the Privacy Rule?

There are several things that would ensure that you comply with the Rule when participating in the survey.  First, the privacy notice that you provide to your patients must indicate that patient information may be disclosed for research or public health purposes. Many of the model notices that have been developed and made available by professional associations provide for this.

Also, we have provided and made available on our website the material that you may need to verify, under the requirements of the Privacy Rule, that you are allowed to disclose to CDC the information requested as part of this survey. This includes the authority under which CDC is collecting this information and that the information being collected is the minimum necessary.

Finally, you will need to keep track of disclosures made for this survey. We will give you a document that contains the information that you need to keep track of the disclosures.

Is there any other information that I need to assess to ensure that my disclosure is authorized under the Privacy Rule?

No. The letter that you received requesting that you participate in this survey is from Rear Admiral, United States Public Health Service, Dr. Anne Schuchat, M.D. Dr. Schuchat is the Director of the National Center for Immunization and Respiratory Diseases, which is part of CDC. The Privacy Rule specifies that you are allowed to disclose information requested for public health purposes to public health agencies such as CDC without patient authorization. The Rule also states that for research projects you may rely on documentation that we have provided indicating that an Institutional Review Board (IRB) has approved a waiver to allow for disclosure with verbal authorization from a parent or legal guardian of the information we are requesting in this survey.

What demonstrates that you are a public health authority?

The survey is sponsored by the National Center for Immunizations and Respiratory Diseases and the National Center for Health Statistics, agencies of the CDC. CDC is a public health authority whose mission is to protect the health of the public. The letter that we sent asking you to participate was sent on official CDC letterhead and described our legislative authority to conduct this survey.

Why do I have to account for these disclosures?

Under the Privacy Rule, patients have a right to an accounting of disclosures that have been made of their identifiable information for various purposes, including disclosures for public health and research purposes. We will provide you with the information you need to account for the disclosures made as part of this survey.

Do I need to worry about whether this is the minimum necessary information for the purposes of the project?

No. The Privacy Rule specifies that in providing information to public agencies, such as CDC, you may rely on our representation that the request constitutes the minimum necessary information required. This issue is also considered as part of the Institutional Review Board (IRB) approval process, and the Privacy Rule specifies that you may rely on the documentation of IRB approval that the information requested is the minimum necessary for the research purpose.

Do I have to have an Institutional Review Board (IRB) review this research project?

No. For research projects, only one IRB must review the project and CDC’s IRB, know as the Research Ethics Review Board, ERB, (which has the authority to review such projects under the Regulations for the Protection of Human Subjects) has done so.  We have a document that indicates that a waiver has been approved by an IRB for this survey, and contains the documentation that is required by the Privacy Rule.  If you desire, your IRB may review the project as well.

What if I want my Institutional Review Board (IRB) to review this project?

Your IRB could verify that the documentation we have provided adheres to the requirements of the Privacy Rule.

Where can I find the requirements of the Privacy Rule?

The entire text of the Privacy Rule can be found at http://www.hhs.gov/ocr/hipaa/

The following parts of the rule were referred to above:

  • Disclosures without patient authorization – 45 CFR 164.512
  • Disclosures for public health activities – 45 CFR 164.512(b) 
  • Disclosures for research purposes – 45 CFR 164.512(i)
  • Verification requirements – 45 CFR 164.514(h)
  • Privacy notice – 45 CFR 164.520
  • Accounting of disclosures – 45 CFR 164.528
  • Minimum necessary requirements – 45 CFR 164.502(b) and 45 CFR 164.514(d)
  • HIPAA guidelines are also available at the following website: http://www.hhs.gov/ocr/hipaa/

Under what legal authority do you collect this information?

This study is authorized by Section 306 of the Public Health Service Act and the National Childhood Vaccine Injury Act of 1986. Through the partnership with the National Center for Health Statistics, the information you supply will be treated confidentially and used for statistical purposes only, as specified by law in Section 308(d) of the Public Health Service Act and the Confidential Information Protection and Statistical Efficiency Act. Information that could identify you, your practice, your facility, the child, or the child's family will not be released. Although your participation is voluntary, we hope that you will choose to participate.

How do I return an immunization history questionnaire?

A pre-paid, addressed envelope was included in the packet of materials along with the request for information about the child’s immunizations. If you do not have the envelope, the address is:

NORC at the University of Chicago
National Immunization Survey
1 North State Street, FL 16
Chicago, IL  60602

If it is more convenient you may fax the information to our toll-free number: 1-866-324-8659

Is it necessary to fill out the entire form?

If you prefer, you may attach a photocopy of the child’s immunization history to the questionnaire and just complete the items on the first page.

Is there someone I can talk with about the NIS-Teen provider survey?

If you have any questions or comments about the materials being requested, please call 1-800-817-4316. If you would like additional information about the National Immunization Survey-Teen, please call Dr. Christina Dorell, MD, MPH, at 404-639-5198, with the National Center for Immunizations and Respiratory Diseases. Your participation in the National Immunization Survey-Teen Provider Record Check Study is greatly appreciated.

What do I do if this adolescent is not my patient or if I have no immunization records for this adolescent?

The first item on the front page of the questionnaire (see below) allows you to indicate this. Please check the appropriate option and return the form so that we do not send you a second request for the information.

1. Which of the following best describes your immunization records for this adolescent?

[] You have all or partial immunization records for this adolescent.
[] Other – Explain
[] You have provided care to this adolescent, but do not have immunization records.
[] You have no record of providing care to this adolescent.

 

Respondents to the National Immunization Survey (NIS Adult)

 

What is the purpose of this study?

This study is designed to help researchers better understand why some adults choose not to get vaccinated for preventable diseases. The data collected from households like yours will help us to understand if certain groups of the population have lower vaccination rates than others. Health care agencies will use this data to ensure that resources are allocated accordingly. Local, state and federal health care agencies will use the information collected to improve vaccination rates among adults (in your area).

Who uses this information?

The National Center for Health Statistics and the National Center for Immunization and Respiratory Diseases (both agencies are part of the Centers for Disease Control and Prevention) will use the results of the study to improve the health and well-being of adults. Through monitoring of this information, Centers for Disease Control and Prevention are able to assess whether immunization goals are being reached. No personal identifiers from survey participants will be released or published.

How are telephone numbers selected?

Numbers are selected in one of two ways. A computer scientifically selects some telephone numbers and others were included as a result of recent participation in the National Health Interview Survey. Regardless of how a number is included, each is selected to represent the community, and since one cannot replace another, input is key to our success.

Is there a letter that explains the study?

Most households selected for the study receive a letter in advance that explains the purpose of the study. This letter is from Dr. Edward J. Sondik, Director of the National Center for Health Statistics. Not all selected households receive a letter in advance, however, because the study does not have the mailing address for all telephone numbers selected for the study. You may view the letter [PDF - 47 KB] or contact the study's telephone survey researchers at 1-800-993-0495 to have a letter sent to your home or to ask us questions about the survey.

What is the legal authorization for the study?

The study, which is conducted on behalf of the U.S. Centers for Disease Control and Prevention, is authorized by the Public Health Service Act [Sections 306 & 2102(a)(7)]. You may call our toll-free number 1-800-223-8118 to verify the legitimacy of this survey and obtain more information. Please mention protocol #2006-04.

How is confidentiality of information assured?

Confidentiality is mandated by law. Findings will be issued only in summary form and U.S. law requires that the name of study participants not be associated with any answers. Unauthorized disclosure of confidential information is punishable by fines ranging from $5,000 to $50,000 and could result in imprisonment for up to 5 years. Also, a section of the NCHS Staff Manual on Confidentiality further explains the prohibitions against disclosure of confidential information.

What information is available about immunizations and about places that provide immunizations?

For more information regarding vaccinations or the phone number of a doctor or clinic near you, please call the Centers for Disease Control and Prevention Information Contact Center at 1-800-232-4636 (1-800-CDC-INFO) and select option 1. For more information about immunization, please visit the web site for the National Center for Immunizations and Respiratory Diseases.

 

 
Spanish (Español)

 

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