September 8, 1998

Mr. Robert D. Crider, Jr.
Director, Immunization Division
1100 West 49th Street
Austin, TX 78756

Dear Mr. Crider:

On March 17, 1998, the Texas Conservative Coalition (TCC) submitted written testimony concerning proposed rules for the immunization tracking registry. In response to that and other public testimony, the Texas Department of Health (TDH) rewrote the rules addressing concerns regarding express parental permission for information to be included in the database.

While the new proposed rules appear to be an improvement over the original rules, there remain several issues that should be addressed and questions that should be answered prior to the adoption of the rules by the Board of Health. Please consider the following:

1. 100. 1(3) - Establishes that all providers of immunizations become agents of the TDH. What is the purpose of making all providers agents of the TDH? Is there a public health benefit which could be created by this provision? Would providers have a lower level of liability if they failed to abide by reporting or confidentiality rules if they were agents of the department?
2. 100. 1(6) - Defines "vaccine" differently than the originally proposed rules. What are the implications of changing the definition? Does the change in definition broaden the scope of immunizations which will be tracked? Does thc new definition differ in any way from any statutory definition of the word "vaccine?"
3. 100.2(a)(1) - Provides for the reporting of demographic information as well as the immunization record of a child to the registry. While the Texas Legislature passed legislation giving TDH the express right to collect immunization records, the legislation carefully described what constituted an immunization record The proposed rules differentiate between demographic information and an immunization record Under what statutory authority is the department collecting demographic information? Even if the department has parental consent to collect the information, what are the limitations of what TDH will ask for under this provision?
4. 100.2(a)(2)(C). (D), (E) and (G) - Provides for the release of information from the registry to entities that are not provided for by statute. For example, the information may be released to a health care plan in which a child is or was enrolled. Why should information be released to a health plan in which a child is no longer participating?
5. 100.2(a)(3) - Provides for a release form for parents to allow for the re-release of information to immunization registries in other states. The language would also allow for the release of information to a national registry in the event one is created. Texas legislators carefully crafted legislation to ensure a parent’s right to include or remove their child’s information in the state registry. This section of rules may be the most objectionable, because once the information is released outside the state of Texas, parents will have no rights concerning their child's information. Furthermore, if the intent of the rules is to allow for the information to be released at the national level, parents should be expressly notified that the information will be released at that level. The information in the registry is already accessible to physicians, schools and daycare centers in other states. It should be a parent’s prerogative to expressly enter their child’s information into another state's registry.
6. 100.2(b) - Allows for a parent’s consent for a child’s future immunization information to be included in the registry by indicating approval on the birth certificate. While this is not prohibited or addressed statutorily, it raises concerns about parents being asked to sign consent forms for the release of medical records at a vulnerable time. Furthermore, anecdotal reports indicate that some parents have stated they did not want to consent to the inclusion of their child’s information in the registry; however, their child's birth certificate indicated that they had consented.
7. 100.7(a) - Allows the department to inspect the immunization records stored with the provider. The original rules provided that the department could inspect the parts of a patient’s medical records as necessary to verify the accuracy of submitted data. The TCC objected to that language because of the danger of compromising confidential medical records. The new language is even more objectionable, because it allows for the inspection of the immunization records stored with the provider for the purpose of verifying submitted data. However, it does not expressly limit the inspection to only those files for which parental consent for release has been obtained. Parent's who do not want their children’s information in this registry also do not want the department inspecting their children’s immunization records.

In conclusion, while the department has made some strides to address the concerns of legislators and parents, those who fear the governmental tracking of law abiding citizens in a free society have not been appeased. On behalf of the Board and members of the TCC, I request that the TDH carefully consider our concerns and not adopt rules until these questions have been answered and the issues resolved to ensure that the privacy of medical records of Texas' children not be compromised against the wishes of their parents

Sincerely,
Kathi Seay
Executive Director, TCC

cc: Commissioner Archer
Board of Health
TCC Board and Members