Frequently Asked Questions about the Surveys for Healthcare Professionals

A: We have discovered that sources of vaccination information from doctors and clinics are the most up-to-date and comprehensive, and more importantly, that the quality of the study's results is much improved by combining the information given by households with that given by the vaccination 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.

A: The HIPAA 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.

A: Healthcare 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.

A: Protected health information includes all medical records and other individually identifiable information used or disclosed by an entity subject to the HIPAA Privacy Rule. This would include directly identifiable information such as patient names or social security numbers.

A: There are several things you must do to ensure 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 include this information.

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

• NIS Documentation Notice for HIPAA Accounting (NEW PDF)
• HIPAA Overview

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.

A: No. The letter you received requesting that you participate in this survey is from Dr. Nancy Messonnier, 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.

A: The survey is sponsored by the National Center for Immunization and Respiratory Diseases, which is part of CDC. CDC is a public health agency 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 legal authority to conduct this survey.

A: Under the HIPAA 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.

A: No. The HIPAA Privacy Rule specifies that in providing information to public health 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.

A: No. For research projects, only one IRB must review the project. The Ethics Review Board, or ERB, has the authority to review such projects under the Regulations for the Protection of Human Subjects and has done so. We have a document that indicates that a HIPAA 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. Please feel free to call the Ethics Review Board at the toll-free number 1-800-223-8118 if you have any questions.

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

A: HIPAA guidelines are available 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)

The following may also be useful:

• HIPAA Privacy Rule and Public Health
• Clinical Research and the HIPAA Privacy Rule

A: This study is authorized by Section 306 of the Public Health Service Act and the National Childhood Vaccine Injury Act of 1986. The Centers for Disease Control and Prevention (CDC) and the contractor must treat, the information you supply confidentially and can only use the information for statistical purposes, as specified by law in Section 308(d) of the Public Health Service 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.

A: Federally Qualified Health Center, as defined under section 1905(l)(2) of the Social Security Act, receives grants under Section 330 of the Public Health Service Act. (B) The term “Federally-qualified health center” means an entity which:

1. is receiving a grant under section 330 of the Public Health Service Act[282],
2. (I) is receiving funding from such a grant under a contract with the recipient of such a grant, and
3. meets the requirements to receive a grant under section 330 of such Act.

A Rural Health Clinic, as defined under section 1905(l)(1) of the Social Security Act, is a clinic certified to receive special Medicare and Medicaid reimbursement.

An FQHC Look-Alike is an organization that meets all of the eligibility requirements of an organization that receives a PHS Section 330 grant, but does not receive grant funding.

Information about FQHCs is available from HRSA’s website at: http://www.bphc.hrsa.gov/about/index.html.

To find health centers: http://findahealthcenter.hrsa.gov/Search_HCC.aspx.

A: Deputization is the formal extension of VFC authority to provide VFC vaccines to eligible underinsured children from a participating FQHC or RHC to another VFC-enrolled provider. Under this arrangement, the deputizing FQHC or RHC retains its full scope of authority as a VFC provider while extending the authority to deputized VFC providers to immunize underinsured children with VFC vaccine.

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

NORC at the University of Chicago
National Immunization Survey
55 E Monroe Street, FL 19
Chicago, IL 60603

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

A: 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.

A: 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 questionnaire 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.

A: If you have any questions or comments about the materials being requested, please call NORC at the University of Chicago at 1-800-817-4316. Someone will be available to answer the call from 8AM to 5PM Central Time.

A: For information about the Immunization History Questionnaire:

• Call our survey contractor, NORC, toll -free at 1-800-817-4316 or e-mail NORC at nisinfo@norc.org.

For survey information:

• See About NIS.
• If you would like additional information about any of the National Immunization Surveys, please call the National Center for Immunization and Respiratory Diseases, at 1-404-718-4838 or e-mail at nis@cdc.gov.

For information about NIS and NIS Teen human subjects and confidentiality protection:

• Call the Research Ethics Review Board at the toll-free number 1-800-223-8118.

For information on the vaccinations:

• Visit CDC’s Vaccines website.

Your participation in the National Immunization Surveys Provider Record Check Study is greatly appreciated. Thank you for your help in ensuring the continued health of our nation’s children and teens.