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Texas Department of Health Proposed Rules for Registry Legislation HB 3054

To access this document directly from Texas Register, do the following:
1. Go to the web site: http://www.sos.state.tx.us/texreg/archive/February201998/PROPOSED/health-services.html.
2. Scroll down to Chapter 100. Immunization Registry.


TITLE health-services

Part I. Texas Department of Health

 Chapter 100. Immunization Registry

25 TAC 100.1-100.10

The Texas Department of Health (department) proposes new 100.1-100.10, concerning the establishment of an Immunization Registry. Specifically, the sections define terms used in this chapter; address the criteria for inclusion of information and its confidentiality; the responsibilities of providers and payers; the effect of withdrawing consent; the information to be reported to the registry; data quality assurance; the responsibilities of managed care, health maintenance, and insurance companies; reports back to providers; exchange of information between the department and providers; and use of registry data for school and day care enrollment. The 75th Legislature, 1997 enacted Chapter 900, adding Health and Safety Code, 161.007-161.009 requiring the department to establish an immunization registry and provide for the confidentiality of information it contains. These rules implement the legislation.

Robert D. Crider, Jr., M.S., M.P.A., Director, Immunization Division, has determined that for the first five year period the sections are in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the sections as proposed. Mr. Crider bases his estimate on the fiscal note prepared for the legislature on House Bill No. 3054, which became Chapter 900.

Mr. Crider has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of these sections, is a centralized immunization registry that is the most efficient method for providers, both public and private, to maintain and access a child's immunization history. The public benefits anticipated as a result of reporting to the immunization registry include: better health care for children with less illness and death due to vaccine-preventable diseases, reduced costs due to the elimination of "over-vaccination" or "re-vaccination" because of lost records, reduced occurrences of "missed opportunities" to vaccinate which unnecessarily increase the risk of a child for vaccine-preventable diseases, and greater opportunity for outreach activities in areas of Texas with low immunization levels. Because the immunization records are stored electronically and available from one source, physicians are able to reduce staff time researching immunization histories. The child's complete immunization record will also be more easily available to school nurses, child care centers, and universities which require immunization information for enrollment. Software, installation, training and support for the tracking system, including the phone line access to the database, are provided by the department. The major costs to small businesses associated with the program will be to those medical practices providing immunizations. There will be increased time spent providing information to patients on the program, and providing them with consent forms and forms to decline participation. The consent form is kept with the medical record, so staff time must be spent filing them. These costs will vary from one practice to another depending upon how many patients are treated, how many participate in the program, how much time is devoted to explaining the program to each patient, filing the consents and the value of the staff time devoted to these tasks, and how providers are reimbursed for providing immunizations. Mr. Crider estimates the average cost to be $1.00 per each patient encounter where an immunization is provided. The cost to small businesses will be reduced by automated and streamline billing of immunizations. Aside from the costs to small businesses, there will be certain costs imposed on other persons. Those who wish to decline participation or withdraw consent must communicate this to the department, involving minimal postage, currently $.32, soon to increase to $.35. Large insurers are required to submit data after 1998, and will incur certain staffing and transmittal costs, though larger entities will almost certainly file requested information electronically. The department estimates that the average insurer will incur costs equivalent to $500 per year of participation. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Robert D. Crider, Jr., M.S., M.P.A., Director, Immunization Division, 1100 West 49th Street, Austin, Texas, 78756, (512) 458-7284. Comments will be accepted for 30 days following the date of publication of this proposal in the Texas Register .

The new sections are proposed under the Health and Safety Code, 161.007 which requires the board to adopt rules to implement the immunization registry, and 12.001 which provides the board with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

These new sections affect the Health and Safety Code, Chapter 161.

100.1.Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

Department

-The Texas Department of Health or its authorized agents.

Division

-The Immunization Division of the Texas Department of Health, Central Office, 1100 West 49th Street, Austin, Texas, 78756.

Health Plan

-An insurance company, a health maintenance organization, or another organization that pays or reimburses a provider for immunizations administered.

Immunization history

-An accounting of all vaccines that a child has received.

Immunization record

-An accounting of all vaccines that a child has received.

Immunization registry (ImmTrac)

-The database or single repository that contains immunization records and personal data for identification. This database is confidential, and access to content is limited to authorized users.

Patient, client or child

-Person or individual to whom a vaccine has been administered.

Provider

-Any physician, health care professional, or facility personnel duly licensed to administer vaccines. All providers are eligible to participate in the registry. All providers become agents of the Texas Department of Health for the purposes of the Immunization Registry.

User

-An entity or individual authorized by the department to access registry data.

Vaccine

-Includes toxoids and other immunologic agents which are administered to children and adults to elicit an immune response and thus protect against an infectious disease.

100.2.Inclusion of Information and Confidentiality.

(a)

The immunization registry shall contain information on the immunization history that is obtained by the department under this section of each person who is younger than 18 years of age and for whom consent has been obtained in accordance with this subsection. The department shall remove from the registry information for any person for whom consent has been withdrawn under paragraph (3) of this section. The department shall obtain the written consent of a parent, managing conservator, or guardian of a patient before any information relating to the patient is included in the registry. The consent language should be substantially similar to the text of paragraphs (1), (2) and (3) of this section. The department shall prepare appropriate forms to obtain consent and on request furnish them to providers.

(1)

"I authorize the Texas Immunization Registry to release past, present, and future information concerning my child's immunizations to myself and any:

(A)

public health district;

(B)

local health department;

(C)

physician to the child;

(D)

school or day care facility in which the child is enrolled; and

(E)

the director of the immunization division of the department or his designee.

(2)

"I authorize any of the above entities to further re-release this information to promote the availability of accurate, complete and current, immunization records to those entities and individuals who provide immunization services and follow-up services for immunizations."

(3)

"I understand that I may withdraw, either the consent to place information on my child in the registry or my consent to release information from the registry at any time by written communication to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas, 78756."

(4)

A parent, managing conservator, or guardian of a patient, who agrees to participate should sign a signature block indicating their consent to participate. Parents who decline to participate should sign a statement stating: "I do not want to have my child participate in the Immunization Registry" or a similar statement. Parents choosing this option should mail their statement to the Texas Department of Health, Immunization Registry, 1100 West 49th Street, Austin, Texas, 78756.

(b)

The Bureau of Vital Statistics will provide the option for parental consent for inclusion in the registry on the birth certificate. This consent will be valid for life unless the parent, managing conservator or guardian notifies the department that consent is withdrawn.

(c)

As required by Health and Safety Code, 161.007, all information which identifies individuals shall be protected as medical information in accordance with the Medical Practice Act, Texas Civil Statutes Article 4495b, 5.08.

(d)

As provided in Health and Safety Code, 161.007(g), the department may use the registry to provide notices by mail, telephone, personal contact, or other means to a parent, managing conservator, or guardian regarding his or her child or ward who is due or overdue for a particular type of immunization according to the department's immunization schedule. The department shall consult with health care providers to determine the most efficient and cost-effective manner of using the registry to provide these notices.

(e)

A health care professional or health plan who provides information to the Immunization Registry in good faith pursuant to this section is not subject to civil liability, as described in Health and Safety Code, 161.007(g).

100.3.Providers, Health Plans, and Insurance Companies.

(a)

After December 31, 1998, an insurance company, a health maintenance organization, or another organization that pays or reimburses a claim for an immunization of a person younger than 18 years of age shall provide an immunization history to the department. On or before December 31, 1998, an insurance company, a health maintenance organization, or another organization that pays or reimburses a claim for an immunization of a person younger than 18 years of age may provide an immunization history to the department. Unless informed otherwise by the provider or the department, the organization may assume that consent has been given for any vaccine for which the provider submits a claim or encounter record.

(b)

A provider shall inform each parent, managing conservator, or guardian of each patient about the registry in writing, and provide them with an opportunity to consent to the inclusion of information in the registry.

(c)

External computer systems supplying the registry with immunization data will incorporate an indicator field that records whether written consent for inclusion has been obtained. These include, but or not limited to Integrated Client Encounter System (ICES), Women, Infant and Children (WIC) and Medicaid and other billing systems used by Texas insurers or health plans.

(d)

Providers shall attempt to obtain written consent for tracking and store the consent in the patient's medical record.

100.4.Withdrawal of Consent.

(a)

The department must remove the patient records from the registry upon the written request from a child's parent, managing conservator, or guardian.

(b)

Upon receipt of a request to withdraw described in 100.2(a)(3)of this title (relating to Inclusion of Information and Confidentiality), the entire patient/client record will be removed from the registry. A written confirmation will be provided to the parent, managing conservator, or guardian or withdrawal from the registry within 30 business days of receipt by the Immunization Division.

(c)

The department shall take precautions to see that children whose parent, guardian, or managing conservator have refused or withdrawn consent shall not be included in the registry.

(d)

The department shall prepare appropriate forms to refuse or withdraw consent to participate in the registry, and make them available to providers.

100.5.Reportable Information.

(a)

All vaccines administered after the effective date of these rules, reported to the department will be sent in a manner consistent with these rules and procedures issued by the department. All immunizations will be reported to the registry until the child's 18th birthday.

(b)

A provider reporting directly to the registry will submit all the information required. Required information consists of the following: 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.

(c)

Providers receiving written notifications from parents requesting that their child's immunization data not be reported to the registry will forward the request to the department in a manner prescribed by the department.

(d)

Beginning on January 1, 1997, vaccines administered will be reported to the department by paper forms, electronic transfer, faxed, mailed, telephone, or entered directly into ImmTrac within 30 business days of administering a vaccine in a format prescribed or approved by the department. Reporting by telephone is limited to medical practices that administer vaccine to less than 25 children per month.

(e)

Reports submitted by electronic transmission will meet data quality, format, security, and timeliness standards prescribed by the department.

(f)

Beginning on January 1, 1999, providers must report the following information:

(1)

provider information:

(A)

the health care professional's name (First, Middle Initial, Last);

(B)

business address (Street, City, Zip Code); and

(C)

business telephone number.

(2)

child and parent information:

(A)

child's name and address (First, Middle Initial, Last);

(B)

child's social security number (if known);

(C)

gender of the child;

(D)

child's date of birth; and

(E)

mother's maiden name (if known) (First and Last).

(3)

vaccine information:

(A)

type of vaccine administered;

(B)

date the vaccine was administered;

(C)

vaccine lot number - (if known); and

(D)

name of vaccine manufacturer (if known) If the record has been entered as historical data, lot number and manufacturer are not required. Historical data are immunizations that were given prior to the present date and/or administered by a different provider.

(g)

If consent is obtained, providers should enter historical immunization records.

(h)

After December 31, 1998, a provider shall submit immunization information to the state-wide immunization registry, if not submitted by the provider to an insurance company, health maintenance organization or other organization that pays or reimburses a claim or encounter for an immunization.

100.6.Data Quality Assurance.

(a)

For the purpose of assuring the quality of submitted data, each provider will allow the department to inspect such parts of a patient's medical records as are necessary to verify the accuracy of submitted data.

(b)

A provider will, upon request of the department, supply missing immunization information, if known, or clarify immunization information submitted to the department.

100.7.Managed Care Organizations, Health Maintenance Organizations and Other Insurers (with programs covering Texas residents), Will Provide Immunization Data to the Department.

(a)

Organizations to which providers submit a claim or encounter information for an immunization, will in turn submit the required immunization information to the department within 25 business days from receipt from the provider.

(b)

Automated data exchange will conform to standards prescribed by the department. Data exchange will follow the national standard for data exchange, known as Health Level 7 (HL7), when this format is completed.

100.8.Reports.

(a)

Authorized and registered providers or health plans may request recall and reminder reports from the tracking system to provide notices of an upcoming or overdue immunization.

(b)

The provider, health plan and the department will maintain the confidentiality of all immunization reports.

100.9.Exchange of Records.

(a)

The department, by written agreement with other providers and health plans, may transmit paper or electronic copies of immunization records or reports to registered users of the registry or to other state or national immunization registries.

(b)

The agreement will require that records be used only for immunization tracking and reporting purposes. The identity of a person named in the report will only be released as specified in the agreement.

100.10.Acceptability As An Immunization Record.

The immunization record obtained from the registry will be accepted as an official immunization record of the child for the purposes of satisfying the requirements of school immunization laws and for enrollment in day care facilities.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on February 9, 1998.

TRD-9801838

Susan K. Steeg
General Counsel
Texas Department of Health

Earliest possible date of adoption: March 22, 1998
For further information, please call: (512) 458-7236

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