Various Pretesting Activities (see attached list)

Attachment M - 7317-SSSCL – Director’s Special Sworn Status Cover Letter for Providers

FROM THE DIRECTOR

US CENSUS BUREAU

The U.S. Public Health Service is committed to reaching the Healthy People 2010 objective that at least

90 percent of children in the United States complete their primary vaccination series by their second birthday. To measure progress toward this goal, the Centers for Disease Control and Prevention conducts the National Immunization Survey (NIS). One component of this survey is the Provider Record Check Study. This study collects and reports the most complete information available on the current vaccination levels of preschool children for each state.

On behalf of the Centers for Disease Control and Prevention (CDC), the U.S. Census Bureau is conducting a special study of the National Immunization Survey Provider Record Check Study to measure a new sampling methodology that may improve the coverage of eligible children. While your office or clinic may have participated in this important survey in the past, we ask for your help by making it possible to test these new methods and determine whether they result in improvements to the survey.

We are requesting information from all medical providers on vaccinations given and the dates of vaccination for children 19 through 35 months of age whose parent or guardian participated in the telephone survey. We are allowed to obtain immunization information from your records because the parent/guardian agreed to participate in this study, and verbally consented during their interview to allow us to contact you for their child(ren)’s immunization information. The protected health information requested is the minimum necessary to determine the vaccination status of children in the survey. Enclosed for your information and reference is an article from the Morbidity and Mortality Weekly Report about vaccination coverage levels in the nation. This report is based on the vaccination history reports from medical providers. A copy of the Immunization History Questionnaire that will need to be completed for each child is also enclosed.

Please be assured that there are several ways that the Privacy Rule (as mandated by the Health Insurance Portability and Accountability Act (HIPAA)) allows you to participate in the NIS. Disclosures of patient data are permitted for public health surveillance purposes. In addition, a Privacy Board at the CDC has reviewed this study. Furthermore, a parent or guardian has given verbal authorization for the release of the child’s immunization history to us. Documentation of this verbal consent will be included in the request for immunization data. We invite you to visit the CDC respondent website http://www.cdc.gov/nis for information regarding the survey, including important policies and procedures regarding confidentiality and meeting the HIPAA Privacy Rule requirements. Additional information regarding HIPAA is available at the following website: http://www.hhs.gov/ocr/privacy/hipaa/understanding/special/publichealth/index.html. The Census Bureau will provide you with all of the documentation needed for accounting purposes.

This survey is authorized by Title 42, United States Code, Sections 306 & 2102(a)(7) of the Public Health Service Act and by The National Childhood Vaccine Injury Act of 1986. Legal authorization for the Census Bureau to conduct the survey is granted by Title 13, United States Code, Section 8. The information you provide will be treated confidentially, as specified by law in Section 9 of Title 13. We will not release any information that could identify you, your practice, your facility, the child, or the child’s family. The information collected will be used for statistical purposes only. Although your participation is voluntary, we hope that you will choose to participate in this very important study.

You may participate by completing the enclosed Immunization Survey Special Sworn Status form(s). This form gives you authorization to help the Census Bureau in performing its duty and protects the confidentiality of the children selected for this survey. By signing this form you agree to keep the identity of patients involved in this study confidential. An explanation of the steps to take to maintain this confidentiality is included in this packet. Please note that a separate form (BC-1759(P)) must be completed by each person who will have access to the data sent by the Census Bureau and/or who will be completing the questionnaire(s) for this survey. Copies of the form can be made if additional forms are needed; however, the signature on each form must be original. Furthermore, for your convenience the information in Part A of this form for the Practice/Clinic/Hospital has been preprinted. Please make any corrections to this information on the form. Mail all completed forms in the enclosed prepaid envelope to:

U.S. Census Bureau

Attention SPB/DSPU/64C,

1201 E 10th Street,

Jeffersonville, IN 47132-0001

We request that the Immunization Survey Special Sworn Status forms be completed and returned within seven (7) days of receipt of this letter. Once we receive the signed form(s), we will send copies of the form(s) used to document the parent/guardian verbal consent to disclose information from their child(ren)’s immunization record(s) and copies of the Immunization History Questionnaire(s) to be completed. We estimate that each questionnaire will take approximately 15 minutes to complete. Efforts will be made to consolidate multiple requests for immunization records for children in your practice. However, as the survey collects information continuously over several months, you may receive additional requests for immunization information on other children for whom you provide medical care.

If you have any questions or comments about the enclosed material, or the records being requested, please call 1-XXX-XXX-XXXX. Your participation in the National Immunization Survey Provider Record Check Study is greatly appreciated.

Sincerely,

[Electronic Signature] [Electronic Signature]

[Director’s Name] Anne Schuchat, M.D.

Director, U.S. Census Bureau Rear Admiral, United States Public Health Service

Director, National Center for Immunization and Respiratory Diseases

Enclosures:

Immunization Survey Special Sworn Status Forms (2)

Explanation of the Immunization Special Sworn Status (2)

Immunization History Questionnaire

MMWR article

Frequently Asked Questions about the HIPAA and the NIS

Business Reply Envelope