TEXAS CONSERVATIVE COALITION
P.O. Box 2659 Austin, Texas 78768
Written Comments by Kathi Seay
With the Texas Conservative Coalitlon1
Regarding Proposal Rides for the Immunization Registry
Submitted to Robert D. Crider, Jr., M.S., M.P.A.
Director of the Immunization Division
Texas Department of Health
Members of the Texas Conservative Coalition (TCC) worked with representatives of the Texas Department of Health (TDH) during the regular session of the 75th Legislature in order to reach a compromise on legislation which would authorize an immunization registry. At that time, a number of issues of concern were addressed.
Many parents are opposed to a governmental agency tracking personal information on law abiding citizens. Therefore, it was crucial to those parents that they have the right to refuse to have their child's name included in the registry. Specifically, TCC members insisted that any legislation should have provisions for a parent's informed consent before information could be stored in the registry. House Bill 3054 was amended in the Senate to include both a provision for informed written consent and a provision that providers and health plans would not be required to submit data if they had not received written consent.
After reviewing the proposed rules for the immunization registry, some TCC members are concerned that the proposed rules would allow for the collection of more information than the Legislature intended. Furthermore, the rules never tell a provider or health plan that they are not required to provide an immunization history to the department for a person for whom consent has not been obtained in accordance with the guidelines. The rules are silent on how a provider or health plan may withhold that information; thereby, leading providers to believe that they must report every immunization. Because it was important enough for the Legislature to include in the legislation a provision which stated that providers and health plans would not be required to provide immunization history for whom consent had not been obtained, it would be prudent for the department to include a corresponding provision in the rules.
The following is a list of some of the concerns about the proposed rules:
(1) The Texas Conservative Coalition is an organization of and for state legislators committed to shaping public policy for the good of all Texans through the promotion of conservative principles. Those conservative principles are embodied in the concepts of limited government, free enterprise, individual liberties and traditional family values. Currently, the Coalition has 96 members -- 86 state representatives and 10 state senators. (Membership list attached.)
|
Section |
Point in Question |
Concern w/ Rules |
Legislation / Other Concerns |
|
100.1 |
Definition of immunization registry |
Rules state that ImmTrac would contain immunizations records and personal data for identification |
Provides only for a registry of immunization records. An immunization record is defined in the legislation (Sec. 161.008). The registry should be limited to this information only. |
|
100.1 |
Definition of provider |
Rules make providers agents of the TDH. |
Why is TDH making all providers agents to the dept.? |
|
100.2(a)(1)(E) |
Release of records to the director of the immunization division of the TDH or his designee |
Rules provide for the release of records to an individual not included in the legislation. |
Legislation specifies to whom the information may be released. (Sec. 161.008(c)(2). The director of the immunization division is not included. |
|
100.2(a)(2) |
Re-release of information |
Rules provide for the re-release of information |
There is no provision in the legislation for the re-release of this information. If this section of consent is in order to allow the dept. to share the information with a national immunization registry, the consent form should clearly state that so that parents will know that their child will be tracked at the national level. |
|
100.2(a)(4) |
Opting out of the registry procedure |
Rules require that if a parent chooses not to have a child included, the parent must mail the denial to the TDH. |
Not prohibited in legislation, however, a parent should be accorded the same service regardless of whether or not they include a child in the registry. If providers handle consent forms, they should also handle denial forms. |
|
100.2(b) |
Consent through birth certificate |
Rules provide the option for parental consent for inclusion in the registry on the birth certificate. The consent would be valid for life. |
Not prohibited or addressed in legislation. However, this may be a vulnerable time for some parents to sign consent forms. Parents should not be expected to sign consent forms for the release of medical records at the same time they are signing birth certificate. |
|
100.3(a) |
Assumption of consent |
Rules state that an insurance company, HMO, or other organization may assume consent has been given unless otherwise notified. |
Consent for inclusion in the database should never be assumed. It has either been given or denied. |
|
100.3(d) |
Requiring an attempt to obtain written consent |
Rules state that providers shall attempt to obtain written consent. |
Legislation stipulates that the written consent of a parent is required before information may be included in the registry. |
|
100.5(b) |
Definition of required information |
The rules require last name, first name, date of birth, sex and address of the child who is immunized, name of parent, guardian or managing conservator and relationship to child, vaccine administered and lot number and manufacturer of the vaccine administered. Other information specified on forms and data file layouts should be provided when available. |
The legislation only provides that the immunization record consists of the name and data of birth of the person immunized, dates of immunization, types of immunization administered and the name and address of the health car provider administering the immunization. The rules include information beyond what required by the legislation. |
|
100.5(c) |
Forwarding denials to the TDH |
The rules would require providers to report to the TDH the denial request of parents who do not want their child's immunization data to be included in the registry. |
The legislation requires only that information for persons for whom consent has been obtained be reported to the agency. (Sec. 161.007(b)) There is no requirement that providers furnish the names of those parents who do not wish their children to be tracked. |
|
100.5(f) |
Reportable information |
The rules require that providers report far more information that what is required by the legislation. |
See required information.(above). The additional information is not necessary in order to accomplish the goal of the tracking registry. |
|
100.6(a) |
Data quality assurance |
The rules stipulate that each provider would allow the department to inspect patient's medical records to verify the accuracy of submitted data. |
There is no provision for this in the legislation. Furthermore, this raises major concerns about confidentiality of medical records. |
|
100.9(a) |
Exchange of records |
The rules allow for the release of information to other state or national immunization registries. |
There is no provision for the sharing of records in the legislation. Parents should have to give specific consent for their child's records to become part of a national registry. This activity is not necessary to accomplish the stated goals of the registry. |