TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 97. COMMUNICABLE DISEASES

Subchapter B. IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION

25 TAC §97.63, §97.77

The Texas Department of Health (department) proposes amendments to §§97.63 and 97.77 concerning immunization requirements for children in Texas elementary and secondary schools and institutions of higher education. These amendments accomplish two changes. The first change clarifies the applicability of these requirements to all students enrolled in health-related courses that will involve direct patient contact in medical or dental care facilities. The existing language suggests to some readers that these rules apply only to specific subgroups of students. A second change is required to allow a newly licensed dosing regimen for hepatitis B vaccine to meet the existing requirement for that vaccine. Rules currently require three doses of hepatitis B vaccine. One brand of hepatitis B vaccine has recently been licensed by the Food and Drug Administration (FDA) for a two-dose series. The proposed change will allow physicians to use this regimen to meet school and day-care attendance requirements. Use of this alternative regimen (and any other alternatives that may be approved in the future) is acceptable only when it is clearly documented that an alternative regimen was followed. Documentation must include both the vaccine manufacturer and dosage for all doses received of that vaccine. Sections 97.61-97.62, 97.65, 97.67, and 97-71-97.77(d) are also open for comment. They are being reviewed in accordance with the requirements of the General Appropriations Act, 75th Legislature (1997), Article IX, Sec. 167, and the General Appropriations Act, 76th Legislature (1999), Article IX, §9-10.13, and Government Code §2001.039, added by Chapter 1499, Article 1, §1.11(a), 76th Legislature (1999). Sections 97.61-97.62, 97.65, 97.67, and 97-71-97.77(d) have been reviewed and the department has determined that the reasons for adopting the sections continue to exist; however, revisions are proposed for §§97.63, 97.77(e) and 97.77(f).

The department published a Notice of Intention to Review §§97.61-63, 97.65, 97.67, and 97.71-97.77 as required by Government Code §2001.039 in the Texas Register on January 14, 2000 (25 TexReg 275). Comments in support of this section were received from representatives of the Texas Pediatric Society and the Texas Medical Association.

Robert D. Crider, 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 the section as proposed.

Mr. Crider has also determined that for the first five years the sections are in effect, the public benefit anticipated as a result of enforcing the sections will be improved compliance with the immunization requirements. There will be no effect on small businesses or micro-businesses because these rules apply only to individuals and educational institutions. There are no anticipated economic costs to persons who are required to comply with the amendments as proposed. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Mr. Robert D. Crider, M.S., M.P.A., Director, Immunization Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512)458-7284, or (800) 252-9152. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

These amendments are proposed under Education Code §51.933 which authorizes the Texas Board of Health (board) to require immunizations for students at any institution of higher education who are pursuing a course of study in a human or animal health profession; Health and Safety Code, §81.004, which authorizes the board to adopt rules necessary for the effective administration and implementation of this chapter; §81.023, which authorizes the board to develop immunization requirements for children; and §12.001 which requires the board to adopt rules for the performance of each duty imposed by law on the board or department.

These amendments affect the Health and Safety Code, Chapter 81.

§97.63.Required Immunizations.

(a)-(b)

(No change.)

(c)

The following immunizations are required in the respective age groupings. A child or student must meet all the immunization requirements specific to an age group upon first entering the age group. Implementation of requirements for hepatitis B vaccine for adolescents and varicella vaccine and hepatitis A for all ages is contingent upon the appropriation of funds to the department for these purposes. By July 1 of each odd-numbered year, the department will publish a statement on whether or not these vaccines have been funded and are required as specified.

(1)- (2)

(No change.)

(3)

Students in institutions of higher education (colleges, universities, and other teaching facilities above the high school level).

(A)

Applicability. This paragraph applies to all students enrolled in health- related courses which will involve direct patient contact in medical or dental care facilities. This includes all medical interns; residents; fellows; and others who are being trained in medical schools, hospitals, and health science centers listed in the Texas Higher Education Coordinating Board's list of higher education in Texas; and students attending two-year and four-year colleges whose course work involves direct patient contact regardless of: number of courses taken; number of hours taken; and classification of student. Subparagraph (I) of this paragraph also applies to veterinary medical students whose course work involves direct contact with animals or animal remains regardless of number of courses taken; number of hours taken; and classification of student. The department will assist institutions of higher education to educate all students of the need for immunizations and will assist in the provision of vaccines as resources allow.

(B)

Provisional enrollment. Students referenced in this paragraph may be provisionally enrolled for up to one semester or one quarter. The provisional enrollment will allow students to attend classes while obtaining the required immunizations and documentation (immunization records) of required immunizations. Student health care providers cannot be provisionally enrolled without receipt of at least one dose of MMR vaccine if direct patient contact will occur during the provisional enrollment period. For further information see §97.62 of this title (relating to Exclusions from Compliance); §97.65 of this title; §97.67 of this title; §97.73 of this title (relating to Acceptable Documents of Immunizations); and §97.77 of this title. Other sections of this chapter regarding immunizations also affect college/university students and institutions of higher education.

(C)

(No Change.)

(D)

Tetanus/Diphtheria. Beginning January 1, 1992, tetanus/diphtheria toxoid (Td) is required for all students defined previously [ medical interns, residents, fellows, and students enrolled in health-related courses as defined ] in subparagraph (A) of this paragraph. Students enrolled in health-related courses must have received one dose of Td within the past ten years. For recordkeeping, only one date (month, day, year) for Td must be recorded, this dose is the Td dose administered within the past ten years.

(E)

(No Change).

(F)

Rubella. Beginning January 1, 1992:

(i)

all students defined previously [ enrolled in health- related courses defined previously ] in subparagraph (A) of this paragraph must show, prior to patient contact, proof of either:

(I)- (II)

(No Change.)

(ii)

(No Change.)

(G)

(No Change.)

(H)

Hepatitis B. Beginning January 1, 1992 , [ : ]

[ (i) ]

all students defined previously in subparagraph (A) of this paragraph [ medical and dental students, residents, and interns ] shall receive a complete series of hepatitis B vaccine prior to the start of direct patient care or show serologic confirmation of immunity to hepatitis B virus. [ All other students enrolled in health-related courses are encouraged to receive the complete series of hepatitis B vaccine; and ]

[ (ii)

all medical and dental interns and residents who are incompletely immunized against hepatitis B virus prior to the start of direct patient care shall complete the series as rapidly as is medically feasible, show serologic confirmation of immunity to hepatitis B virus, or serologic evidence of infection. ] For further information see §97.67 of this title.

(I)

(No Change.)

(J)

Varicella. Beginning August 1, 1999, varicella vaccine is required of all students defined previously [ medical interns, residents, fellows, and students enrolled in health-related courses as defined ] in subparagraph (A) of this paragraph. One dose of vaccine is required for students who received this vaccine prior to 13 years of age; two doses are required for students who were not vaccinated before their thirteenth birthday. All doses of this vaccine must have been received on or after the first birthday. A history of varicella illness (chickenpox) validated by the student, the student's parent or the student's physician or serologic confirmation of varicella immunity is acceptable in lieu of vaccine. For further information, see §97.67 of this title.

§97.77.Remarks and Special Recommendations.

(a)-(d)

(No Change.)

(e)

In some circumstances, the United States Food and Drug Administration may approve the use of an alternative dosage schedule for an existing vaccine. These alternative regimens may be used to meet the requirements specified in §97.63 of this title (relating to Required Immunizations) only when alternative regimens are fully documented. Such documentation must include vaccine manufacturer and dosage received for each dose of that vaccine.

(f)

[ (e) ] Authorities in child-care facilities, schools, and institutions of higher education are required by Health and Safety Code, Chapter 81, Subchapter C, to report, on the day of recognition, all suspected or known cases of vaccine-preventable diseases that occur among students/children or staff, to the local health authority, the city or county health department/district, the city or county health officer, the public health regional office, or the Texas Department of Health in Austin, thus alerting health officials to possible outbreaks of these diseases.

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 May 31, 2000.

TRD-200003866

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: July 16, 2000

For further information, please call: (512) 458-7236


Chapter 137. BIRTHING CENTERS

Subchapter D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES

25 TAC §137.44, §137.55

The Texas Department of Health (department) proposes amendments to §137.44 and §137.55 concerning the regulation of birthing centers. Specifically, the sections cover serologic testing for syphilis and human immunodeficiency virus (HIV) infection, and other state and federal compliance requirements.

Section 137.44 of the birthing center licensing rules requires a birthing center to ensure that its birth attendants comply with Health and Safety Code §81.090 (Act). Prior to the amendments to the Act made by Senate Bill 519, 76th Legislature, 1999, the Act required a physician, or other person permitted by law to attend a pregnant woman during gestation or at delivery of an infant, to take or cause to be taken a sample of the woman's blood at the first examination and visit and to submit the sample to an approved laboratory for testing for syphilis and for HIV infection. The Act also required that a sample be taken from the mother or from the umbilical cord of the infant within 24 hours of delivery and submitted to an approved laboratory for the same testing. Senate Bill 519, 76th Legislature, 1999, amended the Act by adding hepatitis B infection to the list of standard serologic tests that are required, and changed the language relating to the sample of blood from the mother or from the umbilical cord of the infant within 24 hours of delivery, to the mother on admission for delivery. The amendment to §137.44 changes the title of the section to include hepatitis B, and removes the language relating to within 24 hours of delivery.

The amendment to §137.55 concerning other state and federal compliance requirements adds a new subsection (m) which requires birthing centers to comply with the provisions of Health and Safety Code Chapter 47 relating to hearing loss in newborns. New Health and Safety Code Chapter 47 was established by House Bill 714, 76th Legislature, 1999. The department has proposed rules at 25 Texas Administrative Code §§37.501-37.512 which define the department's role in establishing the newborn hearing screening, tracking, and intervention program mandated by Health and Safety Code, Chapter 47. The proposed rules appeared in the Texas Register on December 3, 1999, (24 TexReg 10715).

Jann Melton-Kissel, Bureau of Licensing and Compliance, has determined that for the first five years the proposed sections are in effect, there will be no fiscal implications for state or local governments as a result of enforcing or administering the sections.

Ms. Melton-Kissel also has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing the section will be to ensure compliance by birthing centers with the new legislative mandates. There will be no cost to small/micro businesses to comply with these sections as proposed. (Costs to small or micro businesses which are birthing centers associated with the purchase of the hearing screening equipment required by Health and Safety Code Chapter 47, are addressed in rules proposed by the department at 25 Texas Administrative Code §§37.501-37.512, published in the December 3, 1999, issue of the Texas Register , discussed earlier in this preamble.) There are no anticipated economic costs to persons who are required to comply with the section as proposed. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Cecil Jones, Program Director, Consolidated Programs, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, telephone (512) 834-6646. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

The amendments are proposed under Health and Safety Code, Chapter 244, which authorizes the department to adopt minimum standards necessary to implement Health and Safety Code Chapter 244; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

The amendments affect Health and Safety Code, Chapters 12 and 244.

§137.44.Serologic Test for Syphilis , [ and ] Human Immunodeficiency Virus (HIV) Infection , and Hepatitis B Infection .

A center shall ensure that its birth attendants comply with Health and Safety Code, §81.090 relating to serologic testing during pregnancy [ test for syphilis and HIV infection during pregnancy and within 24 hours of delivery ]. The center shall ensure that the results of any HIV test are kept confidential pursuant to the Health and Safety Code, §81.103.

§137.55.Other State and Federal Compliance Requirements.

(a) - (l)

(No change.)

(m)

A birthing center shall comply with Health and Safety Code, Chapter 47, relating to newborn hearing screening.

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 May 24, 2000.

TRD-200003682

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: July 16, 2000

For further information, please call: (512) 458-7236


Part 2. TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION

Chapter 407. INTERNAL FACILITIES MANAGEMENT

Subchapter E. TDMHMR HISTORICALLY UNDERUTILIZED BUSINESS PROGRAM

25 TAC §407.200

(Editor's note: The text of the following section proposed for repeal will not be published. The section may be examined in the offices of the Texas Department of Mental Health and Mental Retardation or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The Texas Department of Mental Health and Mental Retardation (TDMHMR) proposes the repeal of §407.200, concerning TDMHMR historically underutilized business program, of Chapter 407, governing internal facilities management. The repeal is proposed contemporaneously with the proposal of Chapter 417, Subchapter E, §417.201, governing the same matters.

The proposal of the repeal of §407.200 and the proposal of new §417.201 are made to fulfill the requirements of Texas Government Code §2161.003, which requires state agencies to adopt General Services Commission (GSC) rules for historically underutilized businesses (HUBs) for construction projects and purchases of goods and services paid for with state-appropriated funds The repeal and replacement of §407.200 with §417.201 also would fulfill the requirements of the Texas Government Code, §2001.039, concerning the periodic review of agency rules.

Bill Campbell, deputy commissioner for finance and administration, has determined that for each year of the first five years the proposed repeal is in effect, enforcing or administering the section does not have foreseeable economic implications relating to cost or revenue of the state or local governments.

Mr. Campbell also has determined that, for each year of the first five years the proposed repeal is in effect, the public benefit expected is the good faith effort to increase purchases and contract awards to HUBs. It is anticipated that there would be no additional economic cost to persons required to comply with the proposed section.

It is anticipated that the proposed repeal will not affect a local economy.

It is anticipated that the proposed repeal will not have an adverse economic effect on small businesses or micro-businesses because the proposed new section, which would not place additional requirements on small businesses or micro-businesses, would replace the section proposed for repeal.

Written comments on the proposed repeal may be sent to Linda Logan, director, Policy Development, Texas Department of Mental Health and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668, within 30 days of publication.

The repeal is proposed under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board (board) with broad rulemaking authority; and Texas Government Code, §2161.003, which requires state agencies to adopt the GSC rules governing HUBs.

The proposed repeal would affect the Texas Government Code, §2161.003.

§407.200.TDMHMR Historically Underutilized Business Program.

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 June 2, 2000.

TRD-200003896

Charles Cooper

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Earliest possible date of adoption: July 16, 2000

For further information, please call: (512) 206-4670


Chapter 417. AGENCY AND FACILITY RESPONSIBILITIES

Subchapter E. TDMHMR HISTORICALLY UNDERUTILIZED BUSINESS PROGRAM

25 TAC §417.201

The Texas Department of Mental Health and Mental Retardation (TDMHMR) proposes new Subchapter E, §417.201, concerning the TDMHMR historically underutilized business program, of Chapter 417, governing agency and facility responsibilities. The new section would replace §407.200, relating to TDMHMR historically underutilized business program, of Chapter 407, concerning internal facilities management, which is contemporaneously proposed for repeal in this issue of the Texas Register .

The proposal of new §417.201 and the contemporaneous proposal of the repeal of §407.200 are made to fulfill the requirements of Texas Government Code §2161.003, which requires state agencies to adopt General Services Commission (GSC) rules governing historically underutilized businesses (HUBs) for construction projects and purchases of goods and services paid for with state-appropriated funds The repeal and replacement §407.200 with §417.201 also would fulfill the requirements of the Texas Government Code, §2001.039, concerning the periodic review of agency rules.

Bill Campbell, deputy commissioner for finance and administration, has determined that for each year of the first five years the proposed new section is in effect, enforcing or administering the section does not have foreseeable economic implications relating to cost or revenue of the state or local governments.

Mr. Campbell also has determined that for each year of the first five years the proposed new section is in effect, the public benefit expected is the good faith effort to increase purchases and contract awards to HUBs. It is anticipated that there would be no additional economic cost to persons required to comply with the proposed new section.

It is anticipated that the proposed new section will not affect a local economy.

It is anticipated that the proposed new section will not have an adverse economic effect on small businesses or micro-businesses because they do not place additional requirements on small businesses or micro-businesses than those in the rules proposed for repeal.

Written comments on the proposal may be sent to Linda Logan, director, Policy Development, Texas Department of Mental Health and Mental Retardation, P.O. Box 12668, Austin, Texas 78711-2668, within 30 days of publication.

The section is proposed under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; and Texas Government Code, §2161.003, which requires state agencies to adopt the GSC rules governing HUBs.

The section would affect the Texas Government Code, §2161.003.

§417.201.TDMHMR Historically Underutilized Business Program.

(a)

Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts by reference rules of the General Services Commission (GSC) contained in 1 TAC §111.11-.27 (relating to Historically Underutilized Business Certification Program).

(b)

Copies of the GSC rule are filed in the Office of Policy Development, TDMHMR, 909 West 45th Street, Austin, Texas 78751, and may be reviewed during regular business hours.

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 June 2, 2000.

TRD-200003897

Charles Cooper

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Earliest possible date of adoption: July 16, 2000

For further information, please call: (512) 206-4670