TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 13. HEALTH PLANNING AND RESOURCE DEVELOPMENT

Subchapter F. MEDICALLY UNDERSERVED AREAS AND RESIDENT PHARMACISTS

25 TAC §13.61

The Texas Department of Health (department) proposes new §13.61 concerning medically underserved areas. The new section is proposed in response to the Education Code, Chapter 61, §61.854 which directs each college of pharmacy to give priority consideration to an applicant for a resident pharmacy position who demonstrates willingness to practice pharmacy in medically underserved areas, as defined by the department.

The proposed definition for "medically underserved areas" is an appropriate definition because for over twenty years it has been used by the department and other agencies to denote areas that have a shortage of specific health professionals and/or health care services. It is a federal term defined by the U.S. Department of Health and Human Services (DHHS) and encompasses two medically underserved designation types - Health Professional Shortage Area and Medically Underserved Area. Numerous state and federal programs use one or more of these designation types to identify "medically underserved areas" for their programmatic activities. The department identifies medically underserved areas in the state for designation by DHHS.

Frederic E. Shaw, M.D., J.D., Assistant Commissioner for Policy and Planning, has determined that for each year of the first five-year period the section is in effect, there will be no fiscal implications to state or local government as a result of enforcing or administering the new section as proposed.

Dr. Shaw has also determined that for each year of the first five years the section is in effect, the public benefit anticipated as a result of this section will be clarification of the term "medically underserved area" for use in determining preference for applicants for resident pharmacy positions in colleges of pharmacy. There will be no effect on small businesses or micro-businesses because those businesses are not subject to this section. There are no economic costs to persons who are required to comply with this section as proposed. There will be no effect on local employment.

Comments on the proposal may be submitted to Ann Henry, Acting Director, Office of Policy and Planning, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7261. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

The new section is proposed under the Education Code, §61.854 which authorizes the department to define the term "medically underserved areas," and the Health and Safety Code, §12.001 which authorizes the Texas Board of Health (board) to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The section will affect the Education Code, §61.854.

§13.61.Medically Underserved Areas and Resident Pharmacists.

(a)

This section implements the responsibility of the Texas Department of Health to define the term "medically underserved areas" under the Education Code, §61.854. That section provides that each college of pharmacy shall give priority consideration to an applicant for a resident pharmacist position who demonstrates a willingness to practice pharmacy in medically underserved areas of this state, as defined by the Texas Department of Health.

(b)

The term, "medically underserved areas," is defined as meeting any of the criteria:

(1)

an area in a metropolitan or non-metropolitan area of Texas (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the delivery of health services) which the United States Secretary of Health and Human Services (secretary) determines has a primary care physician shortage and which is not reasonably accessible to an adequately served area as delineated in 42 United States Code (U.S.C.), §254e (42 Code of Federal Regulations (C.F.R.), Part 5);

(2)

a population group which the secretary determines to have such a primary care physician shortage as delineated in 42 U.S.C., §254e (42 C.F.R. Part 5);

(3)

a public or nonprofit private medical facility or other facility which the secretary determines has such a primary care physician shortage as delineated in 42 U.S.C., §254e (42 C.F.R., Part 5); or

(4)

an area with a medically underserved population designated by the secretary as having a shortage of primary care physicians and personal health services as defined in 42 U.S.C., §254c (42 C.F.R., Part 491.5, Subpart A).

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 26, 2000.

TRD-200003750

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: July 9, 2000

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


Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

Subchapter T. SCHOOL-BASED HEALTH CENTERS

25 TAC §§37.531 - 37.538

The Texas Department of Health (department) proposes new §§37.531-37.538 concerning school-based health centers. The new sections are proposed to implement House Bill 2202, Acts 1999, 76th Legislature, §1, which added Education Code, §38.011. This legislation requires the Texas Board of Health (board) to adopt rules to establish procedures for awarding grants to assist school districts with the costs of operating school-based health centers, and to establish standards for health care centers supported by such grants. Specifically, the sections cover the purpose of the rules; definitions; number of awards; dollar amount of awards; matching funds; competitive process, guidelines for requests for proposals; and standards for school-based health centers.

Roy Middleton, Director, Division of Financial Management, Associateship for Community Health and Resources Development, has determined that for the first five-year period the sections are in effect, there will be no loss or increase in revenue, no additional estimated costs, and no estimated reductions in costs. As a result of administering the proposed rules, therefore, there will be no fiscal implications for state government. The proposed rules are simply procedural in nature and specify the means by which funds are to be awarded, subject to the availability of funds, and the standards under which the funded centers will operate. Fiscal implications for local government are variable based on the amount of the grant provided to a particular school district in support of a school-based health center. The maximum possible increase in the school district's biennial budget as a result of its selection for funding through a department grant under this section will be $250,000, all of which must be earmarked for support of the school-based health center described in the funded applicant's proposal. An additional fiscal implication for local government is that any school district receiving funding must provide matching funds and/or in- kind match equal to a proportion of the grant funds, an amount that is indeterminate at present but will be specified in the Request for Proposals.

Roy Middleton has also determined that for the first five years the sections are in effect, the public benefit will be the support of school-based health centers in at least two geographic areas. Mr. Middleton has further determined that there will be no adverse economic effect on any micro- businesses or small businesses, no cost to any persons, and no impact on local employment as a result of the implementation of the new sections, because expenditures for services delivered by health care providers not employed by school districts will increase absolutely, rather than being shifted among current providers.

Comments on the proposal may be submitted in writing to Ruth E. Andersen, School Health Program, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756; by fax at (512) 458-7256; or by telephone at (512) 458-7111, ext. 3014. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

The new sections are proposed under Education Code, §38.011(n), which requires the commissioner of health to adopt rules to establish procedures for awarding grants in accordance with the section; Education Code, §38.011(q), which requires the commissioner of health to adopt rules establishing standards for health care centers funded through said grants; and Health and Safety Code, §12.001, which authorizes the Texas Board of Health (board) to adopt rules for its procedure and for the performance of each duty imposed by law on the board, the department, or the commissioner of health.

The proposed new sections will affect Health and Safety Code, Chapter 32; and Education Code, §§38.0095, 38.011, and 38.012.

§37.531.Purpose.

The purpose of these sections is to establish rules for awarding grants to assist school districts with the costs of operating school-based health centers and to establish standards for the funded centers.

§37.532.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

(1)

Applicant - A school district applying for a grant from the Texas Department of Health to assist with the costs of operating a school-based health center.

(2)

Conventional health services Family and home support; health care, including immunizations; dental health care; health education; and preventive health strategies.

(3)

Department The Texas Department of Health.

(4)

Funded applicant A school district that applies for a grant from the Texas Department of Health to assist with the costs of operating a school-based health center and with which the Texas Department of Health subsequently executes a contract to operate a school-based health center.

(5)

Grant - A sum of money awarded to a selected applicant on the basis of a Request for Proposals that results in a contract.

(6)

Local health education and health care advisory council - Persons appointed by the board of trustees of a school district to make recommendations to the district concerning the establishment of school-based health centers and to assist the district in ensuring that local community values are reflected in the operation of each center. In addition to the majority of appointees who shall be parents of students, the board of trustees shall also appoint at least one person from each of the following groups:

(A)

teachers;

(B)

school administrators;

(C)

licensed health care professionals;

(D)

the clergy;

(E)

law enforcement;

(F)

the business community;

(G)

senior citizens; and

(H)

students.

(7)

Low property wealth per student - An assessed valuation per student in the applicant school district of no more than 25% of the state average assessed valuation per student.

(8)

Rural area - A county with a population of not greater than 50,000, or an area that has been designated under state or federal law as:

(A)

a health professional shortage area;

(B)

a medically underserved area; or

(C)

a medically underserved community as defined by the Center for Rural Health Initiatives.

(9)

School-based health center - An entity established by a school district or by a school district jointly with a public health agency at one or more campuses in the school district to deliver cooperative health care programs, prevention of emerging health threats that are specific to the district, and conventional health services for students and their families.

(10)

Treatment occasion - A number of instances of treatment that constitute a course of treatment for an identified problem or condition.

§37.533.Number of Awards.

The department shall award grants to at least two applicants each state Fiscal Year.

§37.534.Dollar Amount of Awards.

Grants awarded by the department shall not exceed $250,000 per applicant per biennium.

§37.535.Matching Funds.

Funded applicants shall assure the department that matching funds obtained from nonfederal sources, including in-kind contributions, community or foundation grants, individual contributions, and local government agency operating funds, shall be available to the school-based health center project.

§37.536.Competitive Process.

The department shall award grants to applicants annually through a competitive Request for Proposals (RFP) process administered in accord with all applicable policies and procedures of the department, including the RFP guidelines that appear in §37.537 of this title (related to Guidelines for Requests for Proposals).

§37.537.Guidelines for Requests for Proposals.

The department shall complete one Request for Proposals (RFP) process for school-based health centers per state fiscal year according to the following guidelines.

(1)

Proposals submitted in response to the RFP for school-based health centers shall be screened, reviewed, and evaluated according to a competitive process described in full in the RFP.

(2)

The department's School Health Program shall utilize a standard evaluation instrument for scoring applicants' proposals. A copy of the instrument shall be included in the RFP.

(3)

A primary review of all applicants' proposals shall be performed by a member of the School Health Program staff. The reviewer shall award the same number of bonus points to each applicant located in a rural area and/or that has low property wealth per student.

(4)

The School Health Program shall select and train evaluators to score proposals after primary review.

(5)

Proposals shall be evaluated based on the applicant's ability to comply with the department's standards for school-based health centers described in §37.538 of this title (relating to Standards for School-Based Health Centers).

§37.538.Standards for School-Based Health Centers.

Funded applicants shall comply with the following standards for school-based health care centers.

(1)

Community-based solutions. The funded applicant shall facilitate collaboration among families, schools, and members of the community to assess and meet the health needs of the community's children and families. The funded applicant shall utilize the following strategies for facilitating community-based solutions:

(A)

Establish a local health education and health care advisory council to make recommendations to the district on the establishment of school-based health centers and to assist the district in ensuring that local community values are reflected in the operation of each center and in the provision of health education.

(B)

Establish and/or enhance links between school personnel, school-based health center personnel, other health/social services providers and agencies in the community, and other supportive community sectors.

(C)

Enable students and families to be responsible decision-makers in promoting their own health and well-being, making connections with community systems that help to prevent the social isolation and alienation of individuals and families, and using the health care system wisely.

(D)

Encourage parental involvement in and management of the health care of children receiving services from the center; encourage parental accompaniment of any child younger than 15 years of age at visits to the center; notify the child's parent in writing at least one week in advance of the scheduled appointment; and encourage the parent to attend the appointment.

(2)

Administration. The funded applicant shall plan and administer a school-based health center that meets the health needs of the community's children and families by use of the following strategies:

(A)

Deliver primary and preventive health services to children and families in a school-based setting.

(B)

Establish efficient, client-friendly procedures for utilizing all available sources of funding to compensate the district for services provided by the school-based health center, including money available under the state Medicaid program, a state children's health plan program, private health insurance or health benefit plans, and the ability of those using a school-based health center to pay for the services.

(C)

Contract for provision of services at the school-based health center if necessary and appropriate.

(D)

Develop and present a specific, detailed plan for future funding of the school-based health center that demonstrates how the center will continue to operate when grant funding is no longer available.

(E)

Research, develop, and implement the forms and administrative procedures necessary to remain in compliance with all applicable and relevant legislation and regulations. Required procedures contained in applicable legislation for operation of school-based health centers include but are not limited to the following:

(i)

provision of services to a student only if the school district or the provider with whom the district contracts has obtained written consent to the services from the student's parent or guardian within the one-year period preceding the date on which the services are provided, and the consent has not been revoked;

(ii)

joint identification by school-based health center staff and the student's parent or guardian of any health-related concerns of the student that may affect the student's health and/or success in school;

(iii)

provision of neither reproductive services, counseling, nor referrals through the school-based health center using grant funds awarded under this subchapter;

(iv)

provision of all services by only appropriately licensed, certified, or credentialed professionals as required by law;

(v)

referral of a student for mental health services only upon notification of and with the written consent of the student's parent, guardian, or other person having legal control of the student;

(vi)

a good faith effort by staff of a school-based health center located in a rural area described by §37.532(8) of this title (relating to Definitions) to identify and coordinate with existing health care providers;

(vii)

provision of notice by the staff of the school-based health center to the primary care physician of a student who has received services;

(viii)

coordination by the staff of the school-based health center with the primary care physician of any person who has a primary care physician under the state Medicaid program or another health plan before delivering a service;

(ix)

utilization of all available sources of funding to compensate the school district or provider with whom the district contracts for services provided by a school- based health center; and

(x)

conduct or facilitation of the conduct of client surveys in school-based health centers by funded applicants.

(3)

Emphasis on prevention. A funded applicant shall provide for primary emphasis on the delivery of conventional health services and secondary emphasis on the implementation of population-based models that prevent emerging health threats by use of the following strategies:

(A)

increasing substantially the number of children in the community with health-care (medical) homes;

(B)

facilitating access to appropriate primary and preventive care for children and families;

(C)

educating, enabling, and empowering individuals for healthier lifestyles;

(D)

involving the community in identifying priorities and developing health promotion strategies; and

(E)

relying on the evidence of effective prevention to develop interventions that can demonstrate impact.

(4)

Focus on outcomes. A funded applicant shall focus on the achievement of outcomes that can be documented, using the following strategies:

(A)

delivering conventional health services and disease prevention of emerging health threats through access to appropriate primary and preventive care for children and families through a program designed to achieve the following goals:

(i)

a reduction in student absenteeism and drop-out rates;

(ii)

an increase in each student's ability to meet his or her academic potential; and

(iii)

stabilization of each student's physical well-being.

(B)

A funded applicant shall research, document, analyze, and evaluate outcomes, including the goals listed in subparagraph (A) of this paragraph, by activities that include but are not limited to the following:

(i)

gathering data and statistics, monitoring outcomes, and producing data by use of quantitative measurement systems to report on project impact as required by the Request For Proposals;

(ii)

providing quarterly reports as required by the department;

(iii)

conducting client surveys and other qualitative measures of client satisfaction; and

(iv)

producing an annual written report that includes a project evaluation with baseline data; data and analysis from client surveys; any available statistics related to increased academic success, improved student health, and improved performance on student assessment instruments administered under Education Code, Chapter 39, Subchapter B; and other information as specified by the department.

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 26, 2000.

TRD-200003768

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: July 9, 2000

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


Chapter 229. FOOD AND DRUG

Subchapter E. CANNED FOODS

25 TAC §§229.61 - 229.72

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

The Texas Department of Health (department) proposes the repeal of §§229.61 - 229.72, concerning canned foods. The repeal of these rules is necessary because the rules have become obsolete because they are now covered under the Good Manufacturing Practices and Good Warehousing Practices, Chapter 229, Food and Drug, §§229.211 - 229.222.

Pursuant to the Government Code, §2001.039, each state agency is required to review and consider for readoption each rule adopted by that agency. The sections have been reviewed and the department has determined that reasons for adopting the sections no longer exist.

The department published a Notice of Intention to Review for §§229.61 - 229.72 as required by Government Code, §2001.029 in the Texas Register on April 7, 2000, (25 TexReg 3062).

Robert D. Sowards, Jr., Director, Manufactured Foods Division, has determined that for each year of the first five-year period the sections are no longer in effect there will be no fiscal implications to state government or local government as a result of the repeal.

Mr. Sowards also has determined that for each year of the first five years the sections are repealed, the public benefit anticipated as a result of repealing the sections is that the department will be consistent with federal regulations. There will be no effect on small businesses nor micro-businesses. There are no anticipated economic costs to persons who are required to comply with the sections as repealed. There is no impact on local employment.

Comments on the proposal may be submitted to Robert D. Sowards, Jr., Director, Manufactured Foods Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 719-0243. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

The repeals are proposed under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §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 the commissioner of health.

The repeals affect the Health and Safety Code, Chapter 431; Chapter 12; and the Government Code, §2001.039 as passed by the 76th Legislature.

§229.61.General Provisions.

§229.62.Approved Buildings.

§229.63.Implements.

§229.64.Knives.

§229.65.Vegetable Containers.

§229.66.Toilet Facilities.

§229.67.Water Supply.

§229.68.Lavatories.

§229.69.Employee Clothing.

§229.70.Drinking Fountains.

§229.71.Sanitary Supervisor.

§229.72.Nuisances.

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 25, 2000.

TRD-200003719

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: July 9, 2000

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


Subchapter S. PESTICIDES IN FOOD

25 TAC §229.334

The Texas Department of Health (department) proposes an amendment to §229.334 concerning the memorandum of understanding covering the testing for pesticides in food. The amendment will update the location of the memorandum for review by the public.

Pursuant to the Government Code, §2001.039, each agency is required to review and consider for readoption each rule adopted by that agency. The section has been reviewed and the department has determined that reasons for adopting the section continue to exist.

The department published a Notice of Intention to Review for §229.34 as required by Government Code, §2001.039 in the Texas Register on April 7, 2000, (25 TexReg 3062).

Robert D. Sowards, Jr., Director, Manufactured Foods Division, has determined that for each year of the first five-year period the section is in effect the public benefit anticipated as a result of enforcing the section will be knowledge of the exact location where the memorandum can be reviewed. There will be no fiscal implications to state government or local government as a result of the amendment.

Mr. Sowards also has determined that for each year of the first five years the section is amended, there will be no effect on the public, small businesses or micro-businesses. There are no anticipated economic costs to persons who are required to comply with the section amended. There is no impact on local employment.

Comments on the amendment may be submitted to Robert D. Sowards, Jr., Director, Manufactured Foods Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 719-0243. Comments will be accepted 30 days following publication of the proposal in the Texas Register .

The amendment is proposed under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §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 the commissioner of health.

The amendment affects the Health and Safety Code, Chapter 431, Chapter 12; and the Government Code, §2001.039, as passed by the 76th Legislature.

§229.334.Memorandum of Understanding Covering the Testing for Pesticides in Food.

(a)

The Texas Department of Health adopts by reference a memorandum of understanding (MOU) covering the positive results of testing conducted for pesticide in food. The MOU is entered into between the Texas Department of Health, Texas Department of Agriculture, Southwest Region of the United States Food and Drug Administration, and the Office of the Texas State Chemist of the Texas Agricultural Experiment Station.

(b)

Copies of the MOU are available on the Bureau of Food and Drug Safety website, http://www.tdh.state.tx.us/bfds/bfds-hom.htm. Copies are also filed in the office of the Bureau of Food and Drug Safety, [ Division of Food and Drugs, ] Texas Department of Health, 2201 Donley Drive, Suite 200, [ 1100 West 49th Street, ] Austin, Texas 78758 [ 78756 ] , 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 May 25, 2000.

TRD-200003718

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: July 9, 2000

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