Part 1. DEPARTMENT OF STATE HEALTH SERVICES

Chapter 13. HEALTH PLANNING AND RESOURCE DEVELOPMENT

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes amendments to §§13.11, 13.13 - 13.19, 13.31 - 13.34 and 13.61; the repeal of §§13.12, 13.20, and 13.41 - 13.48; and new §13.41, concerning data collection, designation of sites serving medically underserved populations, limited liability certification, and medically underserved areas and resident pharmacists.

BACKGROUND AND PURPOSE

In accordance with the requirements of the Government Code, §2001.039, the sections have been reviewed under the four-year rule review required by state law and the department has determined that reasons for adopting the sections continue to exist in that rules on this subject are needed; however the sections need amending or repeal as described in this preamble.

Section 13.11 and §§13.13 - 13.19 are proposed for amendment in order to require hospitals to submit data under Health and Safety Code, §311.033 and §311.045(a), by an online electronic system rather than by a paper survey form. Section 13.12 and §13.20 are proposed for repeal.

Sections 13.31 - 13.34 are proposed for amendment because of minor changes in language since the sections were last approved.

Sections 13.41 - 13.48 are proposed for repeal and replaced by new §13.41 in order to reflect new hospital reporting deadlines as required by Senate Bill (SB) 1378, 79th Legislature.

Section 13.61 is proposed for amendment due to minor editorial changes in language since the section was last approved.

SECTION-BY-SECTION SUMMARY

Subchapter B (Data Collection), §13.11 and §§13.13 - 13.19, are proposed for amendment to change the method of reporting by hospitals from "either a paper or electronic survey form" to an online electronic method only and as selected by the department. The online system will include two hospital surveys required by statute to be reported to the department by Health and Safety Code, §311.033 and §311.045(a): the Annual Survey of Hospitals (ASH, an online survey hosted by the American Hospital Association (AHA)) and the Annual Statement of Community Benefits Standard (ASCBS) paper survey. Combining these two surveys into one survey form will reduce the department's workload because it will no longer be necessary for department staff to enter ASCBS hospital charity care data by hand into a database file.

The proposed amended rules will also streamline how the data are edited and verified and will allow the department to more easily meet statutory reporting deadlines to the Offices of the Comptroller and Attorney General. These proposed amendments have been discussed with the Texas Hospital Association, AHA, and several hospital staff. The stakeholders believe the online system will help hospitals by requiring them to provide financial, utilization, and charity care data to the department through one survey form rather than two survey systems. The proposed amendment also substitutes Department of State Health Services for the older name of the agency, Texas Department of Health.

These rules are based on Health and Safety Code, §311.033 and §311.045(a). Since the enactment of these rules, the department has obtained the technology to collect and receive survey data from hospitals and systems through an electronic (online) system. Section 311.033 is the annual survey of hospitals that is already available online. These rules will no longer allow filing of a hard copy. Section 311.045(a) is the ASCBS. These rules will require online filing of the ASCBS. Section 311.046(a)(5) requires a nonprofit hospital and hospital system to prepare an annual report of the community benefits plan that shall include specific information along with completed Worksheet 1-A that computes the ratio of cost to charge for the fiscal year referred to in §311.046(a)(4). The worksheet was adopted by the department in August 1994 for use in the ASCBS survey. With the proposed change to electronic reporting in 2007, the department will continue to collect the salient information collected by Worksheet 1-A, but not in the same paper format. Section 311.046(b) requires nonprofit hospitals and hospital systems to prepare an annual report of their community benefits plan that contains specific hospital data and to report this information to the department. Filing the ASCBS online will satisfy part of the requirements of §311.046.

Subchapter C (Designation of Sites Serving Medically Underserved Populations), §§13.31 - 13.34, is proposed for amendment in order to authorize the department to use "Site-MUP" as an abbreviation for "sites serving medically underserved populations," to reflect a name change from Texas Department of Health to the Department of State Health Services, and to change who the applications should be mailed to in the Department of State Health Services, since the Office of Policy and Planning has been renamed the Center for Health Statistics.

Subchapter D (Limited Liability Certification), §§13.41 - 13.48, concerns the certification of a nonprofit hospital or hospital system as a legal entity for the purpose of limited liability of non-economic damage awards. It caps or limits the amount of money awarded to patients who sue hospitals for pain and suffering awards (non-economic damage awards). New §13.41 will incorporate the new statutory certification and reporting requirements and deadlines required by Senate Bill (SB) 1378, 79th Legislative Session. The proposed new rule covers definitions, eligibility rules for certification, mandatory deadline for hospitals to request certification, duties of the department in certifying hospitals and systems, how the department will verify eligibility, and the effective date of certification. Health and Safety Code, §311.0456, requires the department to certify nonprofit hospitals and hospital systems for limited liability for non-economic damage awards if the hospitals or hospital systems meet certain charity care criteria stated in the law. The date for the department to certify hospitals and hospital systems was changed by SB 1378 from April 30th of each year to December 31st of each year.

Subchapter F (Medically Underserved Areas and Resident Pharmacists), §13.61, is proposed for amendment to change the Texas Department of Health to the Department of State Health Services.

FISCAL NOTE

Bruce Gunn, Ph.D., Manager, Health Provider Resources Branch, Center for Health Statistics, has determined that for each year the sections will be in effect, there will be no fiscal impact on state or local governments as a result of administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Bruce Gunn, Ph.D. has also determined there will be no effect on small businesses or micro-businesses as a result of the proposed sections. This was determined by interpretation of the rules that those entities will not be required to alter their business practices to comply with the sections as proposed. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There will be no effect on local employment.

PUBLIC BENEFIT

Bruce Gunn, Ph.D. has determined that for each of the first five years that these sections are in effect, the following public benefits are anticipated:

Subchapter B, §13.11 and §§13.13 - 13.19. As a result of amending this subchapter and repealing §13.12 and §13.20, the department will collect more accurate and useful hospital financial, utilization, and charity care data and will improve the timeliness of submitting reports to the Texas State Comptroller's office and the Office of the Attorney General under the deadline required by §311.0455 related to nonprofit hospital data. The reason for this is that the data will be collected with an online survey rather than a paper survey.

Subchapter C, §§13.31 - 13.34. These amendments are editorial in nature and correct references to the department.

Subchapter D, §13.41. The public benefit will be the improved and timely determination of a hospital's eligibility for limited liability certification. The change in certification deadline from May 31st to December 31st will allow the hospital team to use edited and verified hospital data to certify hospitals because hospital charity care data are not routinely verified until later in the year, November through December. Public and for-profit hospitals are not affected by these sections and will not benefit from these amendments. New §13.41 will simplify the rules by incorporating the language in eight sections into one section.

Subchapter F, §13.61. These amendments are editorial in nature and correct references to the department.

REGULATORY ANALYSIS

The department has determined that these proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productively, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Bruce Gunn, Ph.D., Manager, Health Provider Resources Branch, Center for Health Statistics, Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7261 or by e-mail to bruce.gunn@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

Subchapter B. DATA COLLECTION

25 TAC §13.11, 13.13 - 13.19

STATUTORY AUTHORITY

The proposed amendments are authorized by the Education Code, §61.924 which authorizes the department to define medically underserved areas for the resident pharmacy positions; Occupations Code, §157.052 which authorizes the department to define medically underserved areas for sites at which advanced practice nurse practitioners and physician assistants may carry out prescription drug orders; Health and Safety Code, §§311.031 - 311.048 which requires hospitals, including nonprofit hospitals, to provide financial, utilization, and charity care data to the department; §311.0456 which authorizes the department to issue limited liability certification to nonprofit hospitals and hospital systems that meet stated criteria; §311.046 which describes the survey forms and methods of collection of data from nonprofit hospitals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for administration of Health and Safety Code, Chapter 1001.

The amendments affect Education Code, Chapter 61; Occupations Code, Chapter 157; Health and Safety Code, Chapters 311, 531 and 1001; and Government Code, Chapter 531. Review of the rules implements Government Code, §2001.039.

§13.11.Purpose and Scope .

The purpose of the sections in this subchapter [ chapter ] is to implement Health and Safety Code, Chapter 104, Subchapter D, which requires the department to adopt rules covering the collection of data from health care facilities, such as hospitals, and the dissemination of data to facilitate health planning and resource development; Health and Safety Code, Chapter 311, Subchapters C and D concerning the collection and reporting of hospital financial and utilization data including data regarding the provision of levels of charity care by certain nonprofit hospitals, and the submission of an annual report of a community benefits plan by certain nonprofit hospitals. The scope of this subchapter is to describe the criteria and procedures which the department will use in implementing data collection, dissemination, and reporting requirements. This subchapter will cover the collection and dissemination of data from the public or private hospitals that are included in the definition of the term "health care facilities" in the Health and Safety Code, Chapter 104, Subchapter A. The remaining entities included in the definition of the term "health care facilities" are not covered by this subchapter. If data covered by this subchapter will be collected from a public or private hospital that is a general or special hospital licensed under the Health and Safety Code, Chapter 241; a private mental hospital licensed under the Health and Safety Code, Chapter 577; or a treatment facility licensed under the Health and Safety Code, Chapter 464, the data will be collected under authority of and in compliance with the requirements of the Health and Safety Code, Chapters 104 and 311.

§13.13.Definitions.

The following words and terms, when used in this subchapter [ in these sections ], shall have the following meanings, unless the context clearly indicates otherwise.

[(1) Board--The Texas Board of Health.]

(1) [ (2) ] Chapter 104--Provisions relating to the data collection responsibilities of the Department of State Health Services [ Texas Department of Health ] as the state health planning and development agency found within the Health and Safety Code, Title 2.

(2) [ (3) ] Chapter 311--Provisions relating to the powers and duties of hospitals found within the Health and Safety Code, Title 4.

(3) [ (4) ] Charity care--The unreimbursed cost to a hospital of providing, funding, or otherwise financially supporting health care services on an inpatient or outpatient basis to a person classified by the hospital as financially or medically indigent and/or providing, funding or otherwise financially supporting health care services provided to financially indigent persons through other nonprofit or public outpatient clinics, hospitals or health care organizations.

(4) [ (5) ] Community benefits--The unreimbursed cost to a hospital of providing charity care, government-sponsored indigent health care, donations, education, government-sponsored program services, research, and subsidized health services. Community benefits do not include the cost to the hospital of paying any taxes or other governmental assessments.

(5) [ (6) ] Department--The Department of State Health Services [ Texas Department of Health ].

(6) [ (7) ] Donations--The unreimbursed costs of providing cash and in-kind services and gifts, including facilities, equipment, personnel, and programs, to other nonprofit or public outpatient clinics, hospitals, or health care organizations.

(7) [ (8) ] Education-related cost--The unreimbursed cost to a hospital of providing, funding, or otherwise financially supporting educational benefits, services, and programs including education of medical professionals and health care providers; scholarships and funding to medical schools, colleges, and universities for health professions education; education of patients concerning diseases and home care in response to community needs; and community health education through informational programs, publications, and outreach activities in response to community needs.

(8) [ (9) ] Financially indigent--An uninsured or underinsured person who is accepted for care with no obligation or a discounted obligation to pay for the services rendered based on the hospital's eligibility system.

(9) [ (10) ] Government sponsored indigent health care--The unreimbursed cost to a hospital of providing health care services to recipients of Medicaid and other federal, state, or local indigent health care programs, eligibility for which is based on financial need.

(10) [ (11) ] Government-sponsored program unreimbursed costs--The unreimbursed cost to the hospital of providing health care services to the beneficiaries of Medicare, the Civilian Health and Medical Program of the Uniformed Services, and other federal, state, or local government health care programs.

(11) [ (12) ] Health care facility--Regardless of ownership, a public or private hospital, skilled nursing facility, intermediate care facility, ambulatory surgical facility, family planning clinic which performs ambulatory surgical procedures, rural health initiative clinic, urban health initiative clinic, kidney disease treatment facility, inpatient rehabilitation facility, and other facilities as defined by federal law, but does not include the office of physicians or practitioners of the healing arts singly or in groups in the conduct of their profession.

(12) [ (13) ] Health care organization--A nonprofit or public organization that provides, funds, or otherwise financially supports health care services provided to financially indigent persons.

(13) [ (14) ] Hospital--A general or special hospital licensed under the Health and Safety Code, Chapter 241; a private mental hospital licensed under the Health and Safety Code, Chapter 577; and a treatment facility licensed under the Health and Safety Code, Chapter 464.

[(15) Hospital Data Advisory Committee--An advisory group, appointed by the board, which assists the department in carrying out its responsibilities under Health and Safety Code, Chapter 311.]

(14) [ (16) ] Hospital eligibility system--The financial criteria and procedure used by a hospital to determine if a patient is eligible for charity care. The system shall include income levels and means testing indexed to the federal poverty guidelines; provided, however, that a hospital may not establish an eligibility system which sets the income level eligible for charity care lower than that required by counties under §61.023 or higher, in the case of the financially indigent, than 200% of the federal poverty guidelines. A hospital may determine that a person is financially or medically indigent pursuant to the hospital's eligibility system after health care services are provided.

(15) [ (17) ] Hospital system--A system of local nonprofit hospitals under the common governance of a single corporate parent that are located within a radius of not more than 125 linear miles of the corporate parent.

(16) [ (18) ] Medically indigent--A person whose medical or hospital bills after payment by third-party payors exceed a specified percentage of the patient's annual gross income, determined in accordance with the hospital's eligibility system, and the person is financially unable to pay the remaining bill.

(17) [ (19) ] Net patient revenue--An accounting term that shall be calculated in accordance with generally accepted accounting principles for hospitals.

(18) [ (20) ] Nonprofit hospital--

(A) A hospital that is organized as a nonprofit corporation or a charitable trust under the laws of this state or any other state or country and is:

(i) eligible for tax-exempt bond financing; or

(ii) exempt from state franchise, sales, ad valorem, or other state or local taxes. For purposes of determining whether a hospital is "organized" as a nonprofit corporation or charitable trust, the department will look at the entity which holds the hospital license issued by the department; that is the entity which must be organized as a nonprofit corporation or charitable trust.

(B) A "nonprofit hospital" shall not include a hospital that:

(i) is exempt from state franchise, sales, ad valorem, or other state or local taxes;

(ii) does not receive payment for providing health care services to any inpatients or outpatients from any source including, but not limited to, the patient or any person legally obligated to support the patient, third-party payers, Medicare, Medicaid, or any other federal, state, or local indigent care program; payment for providing health care services does not include charitable donations, legacies, bequests, or grants or payments for research; and

(iii) does not discriminate on the basis of inability to pay, race, color, creed, religion, or gender in its provision of services.

(C) A "nonprofit hospital" does not include a hospital that is located in a county with a population under 50,000 where the entire county or the population of the entire county has been designated as a health professional shortage area. A "nonprofit hospital" includes a hospital that is located in a county with a population under 50,000 population where only a subpopulation, partial geographic area or a facility is designated as a health professional shortage area.

(19) [ (21) ] Patient data--Information derived from individual, acute care, inpatient, and outpatient discharge abstract records.

(20) [ (22) ] Subsidized health services--Services provided by a hospital in response to community needs for which the reimbursement is less than the hospital's cost for providing the services and which must be subsidized by other hospital or nonprofit supporting entity revenue sources. Subsidized health services include, but are not limited to, emergency and trauma care, neonatal intensive care, freestanding community clinics, and collaborative efforts with local government or private agencies in preventive medicine.

(21) [ (23) ] Survey--The annual data collection effort conducted by the department to implement the provisions of Health and Safety Code, Chapters 104 and 311.

(22) [ (24) ] Tax exempt benefits--All of the following, calculated in accordance with standard accounting principles for hospitals for tax purposes using the applicable statutes, rules and regulations regarding the calculation of these taxes:

(A) the dollar amount of federal, state, and local taxes foregone by a nonprofit hospital and its nonprofit supporting entities. For purposes of this definition federal, state, and local taxes include income, franchise, ad valorem, and sales taxes;

(B) the dollar amount of contributions received by a nonprofit hospital and its nonprofit supporting entities; and

(C) the value of tax-exempt bond financing received by a nonprofit hospital and its nonprofit supporting entities.

(23) [ (25) ] Unreimbursed costs--The costs a hospital incurs for providing services after subtracting payments received from any source for such services including but not limited to the following: third-party insurance payments; Medicare payments; Medicaid payments; Medicare education reimbursements; state reimbursements for education; payments from drug companies to pursue research; grant funds for research; and disproportionate share payments. For purposes of this definition, the term "costs" shall be calculated by applying the cost to charge ratios derived in accordance with generally accepted accounting principles for hospitals to billed charges. The calculation of the cost to charge ratios shall be based on the most recently completed and audited prior fiscal year of the hospital or hospital system. For purposes of this definition, charitable contributions and grants to a hospital, including transfers from endowment or other funds controlled by the hospital or its nonprofit supporting entities, shall not be subtracted from the costs of providing services for purposes of determining the unreimbursed costs of charity care and government-sponsored indigent health care.

§13.14. Annual Survey of Hospitals (ASH)-- Types of Data To Be Reported.

The types of ASH data which hospitals must submit [ report ] to the Department of State Health Services [ Texas Department of Health ] (department) through the online survey form are as follows:

(1) - (5) (No change.)

§13.15.Survey Forms and Methods of Reporting Data.

(a) The hospital shall use the online survey form specified by the Department of State Health Services [ Texas Department of Health ] (department) for reporting purposes. The department shall provide access to an [ a hard copy or ] electronic survey form, including instructions to each hospital on how to submit hospital data electronically [ for reporting electronically and on paper, to each hospital ] on an annual basis.

(b) The submitting of data for the Annual Survey of Hospitals (ASH) and the Annual Statement of Community Benefits Standard (ASCBS) will be collected by one online survey form; however, the ASCBS will be required only for nonprofit hospitals. In addition, nonprofit hospitals will be permitted to file the ASCBS at a separate date from filing of the ASH data since state law requires the ASCBS to be filed no later than 120 days after the hospital's fiscal year ends and that date may not coincide with the date for the ASH.

(c) [ (b) ] The hospitals shall complete all requested sections on the electronic survey form and submit [ return ] it electronically [ or in paper form by regular mail ] to the department within 60 days of receipt unless the nonprofit hospital chooses to submit the ASCBS at a different date as allowed by Chapter 311 . The hospitals shall submit [ report ] data for the hospitals' most recently completed fiscal year. A copy of the hospital's eligibility system and any other information requested shall be sent [ submitted ] to the department by regular mail.

(d) [ (c) ] The department may request missing or incomplete data by written or telephone request. Hospitals shall complete all requested follow-up in the time frame specified by the department.

(e) [ (d) ] A hospital may, but is not required to, provide the data for the ASH [ required by subsection (b) of this section ] if the hospital:

(1) is exempt from state franchise, sales, ad valorem, or other state or local taxes; and

(2) does not seek or receive reimbursement for providing health care services to patients from any source, including:

(A) the patient or any person legally obligated to support the patient;

(B) a third party payor; or

(C) Medicaid, Medicare, or any other federal, state, or local program for indigent health care.

§13.16.Verification Report.

The department shall send each reporting hospital a copy of its data verification report prior to the publication of the results of the Annual Survey of Hospitals [ survey ]. The hospital shall review the contents of the verification report provided by the department [ computer generated report ]. If modifications to the report are necessary, the appropriate changes shall be made on the report, and the hospital administrator shall sign and return the report to the department within 31 days of receipt. If no changes are reported within 31 days, the department shall consider the hospital's report verified.

§13.17.Duties of Nonprofit Hospitals under Health and Safety Code, Chapter 311.

(a) Annual report of the Community Benefits Plan (CBP) [ community benefits plan ].

(1) The annual CBP report [ of the community benefits plan ] may be filed with the department on a hospital or hospital system basis. A CBP developed by a hospital serves as a hospital's operational plan for serving the community's health care needs and sets out goals and objectives for providing community benefits that include charity care and government-sponsored indigent health care.

(2) A nonprofit hospital or hospital system shall file an annual CBP report [ of the community benefits plan ] with the department no later than April 30 of the following year.

(3) The nonprofit hospital's or hospital system's annual CBP report [ of the community benefits plan ] must include, at a minimum:

(A) (No change.)

(B) a disclosure of the health care needs of the community that were considered in developing the CBP [ community benefits plan ];

(C) - (E) (No change.)

(4) In addition to the annual CBP report [ of the community benefits plan ], a nonprofit hospital or hospital system shall file a completed worksheet as required by paragraph (3)(E) of this subsection no later than ten working days after the date the hospital or hospital system files its Medicare cost report.

(b) Annual statement of community benefits standard (ASCBS) .

(1) Each nonprofit hospital or hospital system shall also report the following information to the department as the ASCBS part of the online survey form [ part of the annual statement ]:

(A) - (H) (No change.)

(2) The ASCBS shall [ annual statement of community benefits standard may ] be filed online with the department on a hospital or hospital system basis.

(3) A nonprofit hospital or hospital system is required to file an annual statement with the department no later than 120 days after the hospital's or hospital system's fiscal year ends; however, the department will accept the ASCBS [ annual statement ] as partially fulfilling the requirement to submit an [ part of the acceptance of the ] annual report of the hospital or hospital system CBP [ community benefits plan ]. The ASCBS [ annual statement ] filed under this subsection shall be based on the most recently completed and audited prior fiscal year of the hospital and shall state which of the standards for providing community benefits has been satisfied. A nonprofit hospital or hospital system may elect to provide community benefits according to any of the following standards:

(A) - (C) (No change.)

(4) (No change.)

(5) A nonprofit hospital or hospital system shall use the ASCBS part of the online survey [ annual statement of community benefits standard ] form and accompanying worksheets developed by the department for reporting under this section. Hospitals electing to report on a system basis shall consolidate the individual hospital information into a single ASCBS [ annual statement of community benefits standard ] form for the online system. A separate set of worksheets shall be completed for each individual hospital included in the system.

(6) The department will accept written revisions of the ASCBS [ annual statement of community benefits standard ] for 30 days after the filing date.

(7) The department may request missing or incomplete data by written or telephone request. Nonprofit hospitals or hospital systems shall answer all requests received from the department [ complete all requested follow up ] in the time frame specified by the department.

(8) - (9) (No change.)

[(10) Under the Tax Code, §171.063(h), a requirement that a nonprofit hospital provide charity care and community benefits in order to be exempt from franchise tax may be satisfied by a donation of money to the Texas Healthy Kids Corporation established by the Health and Safety Code, Chapter 109, provided that:]

[(A) the money is donated to be used for a purpose described by the Health and Safety Code, §109.033(c); and]

[(B) not more than 10% of the charity care required under any provision of the Health and Safety Code, §311.045, may be satisfied by the donation.]

(10) [ (11) ] A nonprofit hospital or hospital system under contract with a local county to provide indigent health care services under Health and Safety Code, Chapter 61 may credit unreimbursed costs from direct care provided to an eligible county resident toward meeting the nonprofit hospital's or hospital system's charity care and government-sponsored indigent health care requirement.

(c) Reporting.

(1) The department shall notify nonprofit hospitals in writing that the annual report of the [ a ] community benefits plan and the online ASCBS form that [ statement of community benefits standard which ] includes a brief summary of charity care policy and community benefits must be filed in accordance with these rules.

(2) - (3) (No change.)

(4) All hospitals or hospital systems shall report any change of ownership which may affect the nonprofit status of the hospital or hospital system to the Center for Health Statistics, Hospital Survey Unit [ Office of Health Information and Analysis, formerly known as the Bureau of State Health Data and Policy Analysis ], at the department within 60 days of the effective date of the change.

(d) Posting of sign. Nonprofit hospitals shall prepare a statement notifying the public that the annual report of the CBP [ community benefits plan ] is public information, that it is filed with the department, and that it is available on request from the Center for Health Statistics, Hospital Survey Unit, Department of State Health Services [ Office of Health Information and Analysis, formerly known as the Bureau of State Health Data and Policy Analysis, Texas Department of Health ], 1100 West 49th Street, Austin, Texas 78756. The statement must indicate the report's availability date and be posted in prominent places throughout the hospital, including, but not limited to, the waiting areas of the emergency room and the admissions office. Nonprofit hospitals shall also print the statement in the patient guide or other materials that provide the patient with information about the hospital's admissions criteria.

(e) (No change.)

(f) Exemptions. A nonprofit hospital is exempt from the reporting requirement in subsection (c) of this section if the hospital is located in a county with a population under 50,000 and in which the entire county or the population of the entire county has been designated as a "Federally designated Health Professional Shortage Area (HPSA)" [ "health professional shortage area" ] during the current or any previous fiscal year and has continued to maintain that designation.

(g) (No change.)

§13.18.Noncompliance with Reporting Requirements.

(a) Reporting of data on the online survey form for the Annual Survey of Hospitals (ASH) [ Data reporting ].

(1) If a hospital does not submit the [ a ] completed online survey form to the Department of State Health Services [ Texas Department of Health ] (department) within the 60-day reporting period and in accordance with [ established in ] §13.15 of this title (relating to Survey Forms and Methods of Reporting Data), the department may institute the following procedures.

(A) The department will notify the entity in writing by certified mail, return receipt requested, that the entity is in noncompliance with department reporting requirements and may be in violation of the Health and Safety Code, Chapter 104. The written notification will also state that the commissioner [ of health ] may request that the attorney general institute and conduct a suit in the name of the state to recover civil penalties if the hospital fails to submit the requested data to the department within 30 days of the date the entity received the notification letter.

(B) If the department does not receive the requested data from the non-responding hospital within the specified time frame, the commissioner [ of health ] may notify the attorney general in writing of the entity's noncompliance. The department will send a copy of the written notification to the hospital.

(2) (No change.)

(b) Report of the Community Benefit Plan (CBP) and the online Annual Statement of Community Benefits Standard (ASCBS) [ Community benefit plans ].

(1) A nonprofit hospital or hospital system that does not timely submit a CBP report [ of the community benefits plan ] to the Department of State Health Services [ Texas Department of Health ] (department) according to the requirements and procedures established in these sections is subject to a civil penalty of not more than $1,000 for each day of noncompliance, under the provisions of Health and Safety Code, Chapter 311.

(2) If a nonprofit hospital or hospital system does not submit a CBP report [ of the community benefits plan ] to the department within the reporting period established in §13.17 of this title (relating to Duties of Nonprofit Hospitals under Health and Safety Code, Chapter 311), the department may institute the following procedures.

(A) The department will notify the entity in writing by certified mail, return receipt requested, that the entity is in noncompliance with department reporting requirements and may be in violation of the Health and Safety Code, Chapter 311. The written notification will also state that the commissioner [ of health ] may request that the attorney general institute and conduct a suit in the name of the state to recover civil penalties if the hospital or hospital system fails to submit the report to the department within ten days after receipt of the written notification letter.

(B) If the department does not receive the CBP report [ of the community benefits plan ] from the non-responding hospital or hospital system within the specified time frame, the commissioner [ of health ] may notify the attorney general in writing of the entity's noncompliance. The department will send a copy of the written notification to the hospital or hospital system.

§13.19.Confidential Data.

(a) The following data received by the Department of State Health Services [ Texas Department of Health ] (department) from a hospital is confidential under authority of the Health and Safety Code, Chapters 104 and 311:

(1) - (2) (No change.)

(b) - (c) (No change.)

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 August 17, 2007.

TRD-200703719

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972

25 TAC §13.12, §13.20

(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 Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

STATUTORY AUTHORITY

The proposed repeals are authorized by the Education Code, §61.924 which authorizes the department to define medically underserved areas for the resident pharmacy positions; Occupations Code, §157.052 which authorizes the department to define medically underserved areas for sites at which advanced practice nurse practitioners and physician assistants may carry out prescription drug orders; Health and Safety Code, §§311.031 - 311.048 which requires hospitals, including nonprofit hospitals, to provide financial, utilization, and charity care data to the department; §311.0456 which authorizes the department to issue limited liability certification to nonprofit hospitals and hospital systems that meet stated criteria; §311.046 which describes the survey forms and methods of collection of data from nonprofit hospitals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for administration of Health and Safety Code, Chapter 1001.

The repeals affect Education Code, Chapter 61; Occupations Code, Chapter 157; Health and Safety Code, Chapters 311, 531 and 1001; and Government Code, Chapter 531. Review of the rules implements Government Code, §2001.039.

§13.12.Scope.

§13.20.Open Records Request Procedures.

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 August 17, 2007.

TRD-200703720

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972

25 TAC §§13.31 - 13.34

STATUTORY AUTHORITY

The proposed amendments are authorized by the Education Code, §61.924 which authorizes the department to define medically underserved areas for the resident pharmacy positions; Occupations Code, §157.052 which authorizes the department to define medically underserved areas for sites at which advanced practice nurse practitioners and physician assistants may carry out prescription drug orders; Health and Safety Code, §§311.031 - 311.048 which requires hospitals, including nonprofit hospitals, to provide financial, utilization, and charity care data to the department; §311.0456 which authorizes the department to issue limited liability certification to nonprofit hospitals and hospital systems that meet stated criteria; §311.046 which describes the survey forms and methods of collection of data from nonprofit hospitals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for administration of Health and Safety Code, Chapter 1001.

The amendments affect Education Code, Chapter 61; Occupations Code, Chapter 157; Health and Safety Code, Chapters 311, 531 and 1001; and Government Code, Chapter 531. Review of the rules implements Government Code, §2001.039.

§13.31.Purpose and Scope.

(a) Purpose. The purpose of these sections is to implement the provisions in the Texas Occupations Code, §157.052, by the establishment of program rules for the determination of sites serving medically underserved populations (Site-MUPs) . Designated sites will be eligible for qualified advanced nurse practitioners and physician assistants to carry out prescription drug orders in accordance with rules developed by the Texas Board of Nurse Examiners and Texas Medical Board [ Texas Board of Medical Examiners ].

(b) Scope. The scope of these sections is to describe the criteria and procedures that the Department of State Health Services [ Texas Department of Health ] (department) will use in determining Site-MUPs [ sites serving medically underserved populations ]. The criteria will apply to sites not already qualified under the other definitions of eligible sites identified in the Texas Occupations Code, §157.052.

(c) Administration. The department shall designate Site-MUPs [ sites serving a medically underserved population ].

§13.32.Definitions.

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

(1) (No change.)

[(2) Board--The Texas Board of Health.]

(2) [ (3) ] Department--The Department of State Health Services [ Texas Department of Health ].

(3) [ (4) ] Eligible client populations--Residents meeting the eligibility criteria for participation in any of the following programs:

(A) federally funded health care programs, including, but not limited to: AIDS (health care delivery programs); community and migrant health centers (Public Health Service Act, §§329 and 330 grantees); family planning; homeless (including Public Health Service Act, §340 grantees); Medicaid; or Medicare;

(B) state funded health care programs, including, but not limited to: AIDS (health care delivery programs); children with special health care needs (CSHCN); Medicaid; state primary health care; or student health centers (state funded colleges and universities); or

(C) locally funded health care programs, including, but not limited to: locally supported nonprofit health care programs; programs funded by city or county governmental entities; or programs funded by hospital districts.

(4) [ (5) ] Primary care physicians--Physicians practicing in family/general practice, obstetrics/gynecology, internal medicine or pediatrics.

§13.33.Criteria for Designating Site-MUPs [ Sites Serving Medically Underserved Populations ].

(a) The department [ Texas Department of Health (department) ] will designate a site located in an area that has an insufficient number of physicians providing services to eligible client populations if it is determined that:

(1) - (2) (No change.)

(b) (No change.)

§13.34.Application Process.

(a) Applicants must submit an application form, provided by the department [ Texas Department of Health (department) ], which includes the following information:

(1) - (2) (No change.)

(3) adequate demonstration that the site meets the criteria in §13.33(a) or (b) of this title (relating to Criteria for Designating Site-MUPs [ Sites Serving Medically Underserved Populations ]); and

(4) (No change.)

(b) (No change.)

(c) Change in location of a designated site. A Site-MUP designation remains in effect if an applicant verifies that the new site remains in the original service area and provides the same services and staffing and serves the same populations that were originally used to designate the site under subsection (a)(1) or (2) of this section.

(d) [ (c) ] If a site is determined ineligible based on the criteria defined in §13.33 of this title [ (relating to Criteria for Designating Sites Serving Medically Underserved Populations) ], the department will notify the applicant in writing.

(e) [ (d) ] Applications should be directed to the Health Professions Resource Center, Center for Health Statistics, Department of State Health Services [ Director, Office of Policy and Planning, Texas Department of Health ], 1100 West 49th Street, Austin, Texas 78756-3199.

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 August 17, 2007.

TRD-200703721

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972

25 TAC §§13.41 - 13.48

(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 Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

STATUTORY AUTHORITY

The proposed repeals are authorized by the Education Code, §61.924 which authorizes the department to define medically underserved areas for the resident pharmacy positions; Occupations Code, §157.052 which authorizes the department to define medically underserved areas for sites at which advanced practice nurse practitioners and physician assistants may carry out prescription drug orders; Health and Safety Code, §§311.031 - 311.048 which requires hospitals, including nonprofit hospitals, to provide financial, utilization, and charity care data to the department; §311.0456 which authorizes the department to issue limited liability certification to nonprofit hospitals and hospital systems that meet stated criteria; §311.046 which describes the survey forms and methods of collection of data from nonprofit hospitals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for administration of Health and Safety Code, Chapter 1001.

The repeals affect Education Code, Chapter 61; Occupations Code, Chapter 157; Health and Safety Code, Chapters 311, 531 and 1001; and Government Code, Chapter 531. Review of the rule implements Government Code, §2001.039.

§13.41.Purpose and Authority.

§13.42.Definitions.

§13.43.Eligible Entities.

§13.44.Certification Criteria.

§13.45.Mandatory Submission Deadline.

§13.46.Duties of the Department.

§13.47.Effective Date of Certification.

§13.48.Effect of Certification.

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 August 17, 2007.

TRD-200703722

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972

25 TAC §13.41

STATUTORY AUTHORITY

The proposed new rule is authorized by the Education Code, §61.924 which authorizes the department to define medically underserved areas for the resident pharmacy positions; Occupations Code, §157.052 which authorizes the department to define medically underserved areas for sites at which advanced practice nurse practitioners and physician assistants may carry out prescription drug orders; Health and Safety Code, §§311.031 - 311.048 which requires hospitals, including nonprofit hospitals, to provide financial, utilization, and charity care data to the department; §311.0456 which authorizes the department to issue limited liability certification to nonprofit hospitals and hospital systems that meet stated criteria; §311.046 which describes the survey forms and methods of collection of data from nonprofit hospitals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for administration of Health and Safety Code, Chapter 1001.

The new rule affects Education Code, Chapter 61; Occupations Code, Chapter 157; Health and Safety Code, Chapters 311, 531 and 1001; and Government Code, Chapter 531. Review of the rule implements Government Code, §2001.039.

§13.41.Limited Liability Certification.

(a) Purpose. This section provides the criteria and procedures the department uses to determine a nonprofit hospital's or hospital system's eligibility for limited liability certification by the department.

(b) Authority. This section is authorized by Health and Safety Code, §311.0456 (§311.0456), which requires the department to receive, determine eligibility, and certify limited liability status for nonprofit hospitals or hospital systems that meet the requirements of these sections.

(c) Definitions. Terms used in this subchapter have the following meanings, unless the context clearly indicates otherwise. Terms not defined have their common meanings.

(1) Department--The Department of State Health Services.

(2) Charity care--Is defined in Health and Safety Code, §311.031(2).

(3) Net patient revenue--Is defined in Health and Safety Code, §311.042(8).

(d) Eligible Entities. This section applies to a nonprofit hospital and hospital system that:

(1) meets the definition of nonprofit hospital in the Health and Safety Code, §311.042(9)(A); or

(2) is a corporation certified by the Texas Medical Board as a nonprofit organization under Occupations Code, §162.001, whose sole member is a qualifying hospital or hospital system.

(e) Certification Criteria. A nonprofit hospital or hospital system that satisfies the eligibility criteria under this section must additionally meet the following certification criteria:

(1) provide charity care in an amount equal to or at least 8% of net patient revenue during the most recent fiscal year of the hospital or system; and

(2) provide at least 40% of the total charity care provided in the county in which the hospital is located.

(A) Charity care for purposes of this section is determined by the department by checking the report submitted by the hospital or system under the Health and Safety Code, §311.033 and the statement of community benefits and charity care submitted by the nonprofit hospital or hospital system under Health and Safety Code, §311.045.

(B) If a report under §311.033 is not available for all hospitals in a county in which a nonprofit hospital meeting the requirement in paragraph (1) of this subsection is requesting certification, the department shall determine the eligibility of the hospital or hospital system using other sources of verified charity care information available at the time of certification.

(f) Mandatory Submission Deadline. Not later than May 31 of each year for which certification is sought, a nonprofit hospital or hospital system must submit a written request for certification stating that the hospital or system is eligible for certification. Reports submitted after May 31 of each reporting year will not be considered for certification, and exceptions to the deadline will not be granted.

(g) Duties of the Department. The department will determine whether a hospital or hospital system is an eligible entity and meets the certification criteria not later than December 31 of the year in which the department receives the request.

(h) Effective Date of Certification. A certification issued under this section to a nonprofit hospital or hospital system takes effect on December 31 of that year for which certification is issued and expires on the anniversary of that date.

(i) Effect of Certification. Section 311.0456 describes the effect of certification on liability for noneconomic damages.

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 August 17, 2007.

TRD-200703723

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972

25 TAC §13.61

STATUTORY AUTHORITY

The proposed amendment is authorized by the Education Code, §61.924 which authorizes the department to define medically underserved areas for the resident pharmacy positions; Occupations Code, §157.052 which authorizes the department to define medically underserved areas for sites at which advanced practice nurse practitioners and physician assistants may carry out prescription drug orders; Health and Safety Code, §§311.031 - 311.048 which requires hospitals, including nonprofit hospitals, to provide financial, utilization, and charity care data to the department; §311.0456 which authorizes the department to issue limited liability certification to nonprofit hospitals and hospital systems that meet stated criteria; §311.046 which describes the survey forms and methods of collection of data from nonprofit hospitals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for administration of Health and Safety Code, Chapter 1001.

The amendment affects Education Code, Chapter 61; Occupations Code, Chapter 157; Health and Safety Code, Chapters 311, 531 and 1001; and Government Code, Chapter 531. Review of the rules implements Government Code, §2001.039.

§13.61.Medically Underserved Areas and Resident Pharmacists.

(a) This section implements the responsibility of the Department of State Health Services (department) [ Texas Department of Health ] to define the term "medically underserved areas" under the Education Code, §61.924 [ §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 department [ Texas Department of Health ].

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

(1) designated by the United States Secretary of Health and Human Services (secretary) as a whole county or partial county Health Professional Shortage Area (HPSA) [ 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 secretary [ 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) designated by the secretary as a population group HPSA 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) designated by the secretary as a facility HPSA for 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) designated by the secretary as an area with a medically underserved population (MUP) and [ 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 August 17, 2007.

TRD-200703724

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972

Subchapter A. RABIES CONTROL AND ERADICATION

25 TAC §§169.21 - 169.34

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes amendments to §§169.21 - 169.34, concerning the control of rabies.

BACKGROUND AND PURPOSE

These rules are necessary to comply with Health and Safety Code, Chapter 826, "Rabies," §826.011, which provides the Executive Commissioner of the Health and Human Services Commission with the authority to administer the rabies control program and adopt rules necessary to effectively administer the program.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 169.21 - 169.34 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

Specifically, the sections cover definitions, information relating to the control of rabies, preexposure rabies vaccination, reports of human exposure to rabies, facilities for the quarantining or impounding of animals, quarantine method and testing, requirements of a quarantine facility, vaccination requirement, disposition of domestic animals exposed to rabies, interstate movement of dogs and cats into Texas, international movement of dogs and cats into Texas, submission of specimens for laboratory examination, and statewide quarantine.

After carefully considering the alternatives, the department believes the rules as amended are the best method of implementing the statute to protect the public health with rules for the control and eradication of rabies in the State of Texas.

SECTION-BY-SECTION SUMMARY

The amendment to §169.21 modifies the language to make it more concise.

The amendment to §169.22 updates the definitions and the legacy agency name.

The amendment to §169.23 changes Zoonosis Control Division to Zoonosis Control Branch.

The amendment to §169.24 clarifies preexposure rabies vaccination.

The amendment to §169.25 clarifies potential rabies exposure.

The amendment to §169.26 updates the legacy agency name, clarifies facility and animal care requirements, and deletes the last paragraph because the date by which compliance was required has passed.

The amendment to §169.27 clarifies language relating to rabies exposure and animal quarantine and disposition.

The amendment to §169.28 clarifies and updates language relating to the requirements of quarantine facilities.

The amendment to §169.29 clarifies the rabies vaccination requirement.

The amendment to §169.30 clarifies language pertaining to disposition of domestic animals exposed to rabies.

The amendments to §169.31 and §169.32 clarify language pertaining to dogs and cats coming into Texas from other states and other countries.

The amendment to §169.33 updates the legacy agency name, and clarifies language pertaining to the submission of rabies specimens for laboratory examination.

The amendment to §169.34 replaces the board with the Executive Commissioner of the Health and Human Services Commission.

The proposed revisions to the sections update and clarify language to enable those subject to the sections to more readily comply. The amendments enhance implementation of a comprehensive rabies control program that will diminish public exposure to rabies, reduce morbidity and mortality from rabies among humans and animals, and provide for humane treatment of animals suspected of rabies.

FISCAL NOTE

Martha McGlothlin, Section Director, Community Preparedness Section, has determined that for each year of the first five-year period that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Ms. McGlothlin has also determined that there will be no effect on small businesses or micro-businesses required to comply with the sections as proposed. This was determined by interpretation of the rule that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the sections. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. The Texas Veterinary Medical Association and the Texas State Board of Medical Examiners were contacted about proposed changes to rabies vaccination certificate requirements; there is not an anticipated fiscal impact for veterinarians who will need to comply with these amendments. There is no anticipated negative impact on local employment.

PUBLIC BENEFIT

In addition, Ms. McGlothlin has also determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections will be that it enhances public health and safety by advising pre-exposure rabies vaccination of persons at high risk for rabies exposure; requiring reporting of potential exposure of humans to rabies; imposing quarantine or testing of animals that potentially exposed a human to rabies; setting standards for the humane and effective quarantine of these animals; establishing minimum standards for vaccination of dogs and cats against rabies with associated recordkeeping and records retention; establishing requirements for the disposition of domestic animals exposed to a rabid animal; establishing rabies vaccination requirements for interstate and international movement of dogs and cats into Texas; establishing standards for the submission of specimens to the department's laboratory for rabies testing; and establishing statewide rabies quarantine for particular wildlife species. After careful consideration of alternatives, the department concludes that the rules, as revised, provide a clear, concise comprehensive policy of rabies control that will diminish public exposure to rabies, reduce morbidity and mortality from rabies among humans and animals, and provide for humane treatment of animals suspected of rabies. This policy is the most efficient use of public and private resources to achieve these goals.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposed amendments do not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, do not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to Tom Sidwa, DVM, Department of State Health Services, Community Preparedness Section, Zoonosis Control Branch, 1100 West 49th Street, Austin, Texas 78756, or by email to Tom.Sidwa@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the proposed rules have been reviewed by legal counsel and found to be within the state agencies' authority to adopt.

STATUTORY AUTHORITY

The proposed amendments are authorized by Health and Safety Code, §826.011, which provides the department with the authority to administer the rabies control program and adopt rules necessary to effectively administer this program; §826.012, which provides that rules adopted by the department are minimum standards for rabies control; §826.042, which provides that the department shall adopt rules governing the testing of quarantined animals and the procedure for and method of quarantine; §826.045, which requires the department to adopt rules to enforce an area rabies quarantine; §826.051, which requires the department to adopt rules governing the types of facilities that may be used to quarantine or impound animals; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

The proposed amendments affect Health and Safety Code, Chapters 826 and 1001; and Government Code, Chapter 531. Review of the rules implements Government Code, §2001.039.

§169.21.Purpose.

The purpose of these sections is to protect [ the ] public health by establishing uniform rules for the control and eradication of rabies in the State of Texas, in accordance with Chapter 826 of the Texas Health and Safety Code.

§169.22.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise. Unless defined below, all words have definitions as provided in the Texas Health and Safety Code, §826.002.

(1) (No change.)

(2) Assistance animal [ dog ]-- An animal [ A dog ] that is specially trained or equipped to help a person with a disability [ physical challenge ] and that:

(A) is used by a person with a disability [ physical challenge ] who has satisfactorily completed a specific course of training in the use of the animal [ dog ]; and

(B) has been trained by an organization generally recognized by agencies involved in the rehabilitation of persons with disabilities [ a physical challenge ] as reputable and competent to provide animals [ dogs ] with training of this type.

(3) Cat--Any domestic cat, excluding hybrids [ Felis catus ].

(4) Confinement--The restriction of an animal to an area, in isolation from other animals and people, except for contact necessary for its care.

(5) [ (4) ] Currently vaccinated--Vaccinated and satisfying all the following criteria.

(A) The animal must have been vaccinated against rabies with a vaccine licensed by the United States Department of Agriculture (USDA) for that animal species at or after the minimum age requirement and using the recommended route of administration for the vaccine [ according to the label recommendations of a United States Department of Agriculture (USDA) approved vaccine ].

(B) At least 30 days have elapsed since the initial vaccination.

(C) The time elapsed since the most recent vaccination has not exceeded the recommended interval for booster vaccination as established by the manufacturer [ label recommendations of the vaccine ].

(6) [ (5) ] Custodian--A person or agency which feeds, shelters, harbors, owns, has possession or control of , or has the responsibility to control an animal.

(7) [ (6) ] Department-- The Department of State Health Services [ The Texas Department of Health (TDH) ].

(8) [ (7) ] Dog--Any domestic dog, excluding hybrids [ Canis familiaris, including hybrids ].

(9) [ (8) ] Domestic animal--Any animal normally adapted to live in intimate association with humans or for the advantage of humans.

[ (9) Domestic dog--Any Canis familiaris, excluding hybrids. ]

(10) Domestic ferret --Any Mustela putorius furo [ Mustela putorius furo ].

(11) Health service region--A contiguous group of Texas counties, so designated by the Executive Commissioner of the Health and Human Services Commission.

(12) [ (11) ] High - risk animals--Those animals which have a high probability of transmitting rabies; they include skunks, bats, [ species of ] foxes [ indigenous to North America ], coyotes, and raccoons.

(13) [ (12) ] Housing facility--Any room, building, or area used to contain a primary enclosure or enclosures.

(14) [ (13) ] Humanely killed--To cause the death of an animal by a method which:

(A) rapidly produces unconsciousness and death without [ visible evidence of ] pain or distress; or

(B) utilizes anesthesia produced by an agent which causes painless loss of consciousness, and death following such loss of consciousness.

(15) [ (14) ] Hybrid--Any offspring of two animals of different species.

(16) [ (15) ] Impoundment--The collecting and confining of an animal by a government entity or government contractor pursuant to a state or local ordinance [ because of a state or local ordinance or because of a contract with a county or municipality ].

(17) [ (16) ] Impoundment facility--An enclosure or a structure in which an animal is collected or confined by a government entity or government contractor pursuant to a state or local ordinance [ because of a state law or local ordinance or because of a contract with a county or municipality ].

[ (17) Isolation--The separation of an animal exposed or potentially exposed to rabies. ]

(18) Local rabies control authority--The officer designated by the municipal or county governing body under the Texas Health and Safety Code, §826.017 [ Chapter 826 ].

(19) Low - risk animals--Those animals which have a low probability of transmitting rabies; they include all animals of the orders Didelphimorphia [ Marsupialia ], Insectivora, Rodentia, Lagomorpha, and Xenarthra.

(20) Observation period--The time following a potential rabies exposure [ bite incident ] during which the [ biting animal's ] health status of the animal responsible for the potential exposure must be monitored. The observation period for [ domestic ] dogs, cats, and domestic ferrets (only) is 10 days (240 hours); the observation period for other animals, not including those defined as high risk or low risk, is 30 days. All observation periods are calculated from the time of the potential exposure.

(21) Police service animal [ dog ]-- An animal as defined in the Texas Penal Code, §38.151 [ Domestic dog that is owned or employed by a governmental law enforcement agency ].

(22) (No change.)

[ (23) Public health region--A contiguous group of Texas counties, so designated by the board. ]

(23) [ (24) ] Quarantine facility--A structure where animals are held for rabies observation.

(24) [ (25) ] Quarantine period--That portion of the observation period during which an animal that has potentially exposed a human to rabies [ a biting animal ] is under physical confinement [ physically confined ] for observation as provided for in §169.27 of this title (relating to Quarantine Method and Testing).

(25) [ (26) ] Sanitize--To make physically clean and to destroy disease-producing agents.

[ (27) Therapy dog--A dog that helps a person with a diagnosed emotional disorder for whom a letter has been issued by a physician stating that the removal of the animal would be detrimental to the person's emotional health. ]

(26) [ (28) ] Unowned animal--Any animal for which a custodian [ an owner ] has not been identified.

(27) [ (29) ] Vaccinated--Properly administered [ injected ] by or under the direct supervision of a [ licensed ] veterinarian with a rabies vaccine licensed for use in that species by the USDA [ United States Department of Agriculture ].

(28) Veterinarian--A person licensed to practice veterinary medicine in the United States.

(29) [ (30) ] Zoonosis Control Branch [ Zoonosis Control Division (ZCD) ]--The branch [ division ] within the department [ Texas Department of Health ] to which the responsibility for administering [ implementing ] these rules is assigned.

(30) [ (31) ] Zoonosis control representative--Any person employed by the department to perform zoonosis control duties [ ZCD ].

§169.23.Information Relating to the Control of Rabies.

The department's Zoonosis Control Branch [ Zoonosis Control Division (ZCD) ] will assume the responsibility of collecting, analyzing, and preparing monthly and annual summations of rabies activity in the state. These reports will be forwarded to national, state, and municipal agencies as required, and selected statistics will be sent to veterinary medical and animal control organizations throughout the state.

§169.24.Preexposure Rabies Vaccination [ Immunization ].

Preexposure rabies vaccinations [ immunization ] should be administered to all individuals whose activities place them at a significant risk of exposure to rabies, in accordance with the recommendations of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices [ CDC Immunization Practices Advisory Committee ] (ACIP).

§169.25.Reports of Human Exposure to Rabies.

(a) Any person having knowledge of a potential rabies exposure to a human [ as defined in the Texas Health and Safety Code, §826.041, ] will report the incident to the local rabies control authority as soon as possible after [ , but not later than 24 hours from the time of ] the incident. This requirement does not apply to contacts with [ bites by ] low - risk animals as defined in §169.22 of this title (relating to Definitions).

(b) The [ owner or ] custodian of an [ the potentially rabid ] animal that has potentially exposed a person to rabies will place that animal in quarantine or submit it for testing as prescribed in §169.27 of this title (relating to Quarantine Method and Testing).

(c) (No change.)

§169.26.Facilities for the Quarantining or Impounding of Animals.

(a) Generally.

(1) - (5) (No change.)

(6) Management. The manager of a quarantine facility should be either [ a licensed veterinarian or ] an individual who has satisfactorily completed an appropriate department [ TDH ] training course or a veterinarian .

(7) - (11) (No change.)

(12) Primary enclosures. Primary enclosures shall:

(A) - (E) (No change.)

(F) provide sufficient space to allow each animal to turn around fully, stand, sit, and lie in a comfortable [ normal ] position.

(b) Feeding.

(1) [ Dogs and cats shall be fed at least once a day except as directed by a licensed veterinarian. ] All [ The ] food shall be free from contamination, wholesome, palatable, and of sufficient quality and nutritive value to meet the normal daily requirements for the condition , size, and age [ and size ] of the animal [ dog or cat ].

(2) Dogs and cats shall be fed at least once a day, except as directed by a veterinarian.

(3) [ (2) ] Domestic ferrets shall have continuous [ 24-hour ] access to food. [ The food shall be free from contamination, wholesome, palatable, and of sufficient quality and nutritive value to meet the normal daily requirements for the condition, size, and age of the domestic ferret. ]

(4) [ (3) ] All other animals shall be fed appropriately as described on the packaging of a commercial, species-specific food or as directed by a veterinarian. [ Food receptacles shall be accessible to all dogs, cats, and domestic ferrets and shall be located so as to minimize contamination by excreta. Food pans or bowls shall be durable and kept clean and sanitary. Disposable food receptacles may be used but must be discarded after each feeding or for domestic ferrets, after 24 hours of use. Self feeders may be used for feeding dry pet foods and shall be kept clean and sanitary. ]

(5) Food receptacles shall be accessible to all animals and shall be located so as to minimize contamination by excreta. Food receptacles shall be durable and kept clean and sanitary. Disposable food receptacles may be used but must be discarded after each feeding or, for domestic ferrets, after 24 hours of use. Self feeders may be used for feeding dry foods to animals acclimated to their use.

(c) Watering. If potable water is not accessible to all animals [ dogs and cats ] at all times, it shall be offered to them at least twice daily for periods of not less than one hour, except as directed by a [ licensed ] veterinarian. Drinking bottles may be used for animals acclimated to their use. Domestic ferrets shall have potable water accessible at all times, provided in drinking bottles of appropriate size to maintain a fresh supply. Water receptacles shall be kept clean and sanitary.

(d) (No change.)

(e) Pest Control. A regular program for the control of insects, ectoparasites, and other pests shall be established and maintained. The facility shall be free of visible signs of insects, rodents, and other vermin infestations at all times.

(f) (No change.)

(g) This section applies to all animal shelters located in counties with a population of 75,000 or greater as required by the Texas Health and Safety Code, Chapter 823 , and to all quarantine or impoundment facilities regardless of county population.

[ (h) Impoundment facilities in counties with a population less than 75,000 have until January 16, 2005, to be in compliance with the minimum standards set forth in this section. ]

§169.27.Quarantine Method and Testing.

(a) When a [ domestic ] dog, cat, or domestic ferret which has potentially exposed [ bitten ] a human to rabies has been identified, the [ owner or ] custodian will [ be required to ] place the animal in quarantine as defined in the Texas Health and Safety Code, §826.002, until the end of the 10-day observation period. The observation period will begin at the time of the exposure. [ Unvaccinated animals should not be vaccinated against rabies during the observation period; however, animals may be treated for unrelated medical problems diagnosed by a veterinarian. The observation period will begin at the time of the bite incident. If the animal becomes ill during the observation period, the local rabies control authority must be notified by the person having possession of the animal. ] The animal must be placed in a department - licensed quarantine facility specified by the local rabies control authority and observed at least twice daily. However, the local rabies control authority may allow the animal to be quarantined [ placed ] in a veterinary clinic. As an alternative, the local rabies control authority may allow home confinement [ quarantine if the following criteria can be met ]. If the potential rabies exposure occurs in a city or county other than where the animal's custodian resides, the animal may be transferred to a department-licensed quarantine facility or a veterinary clinic in the city or county of the custodian's residence or allowed home confinement, if applicable, if there is mutual agreement to do so between the local rabies control authorities for the city or county where the exposure occurred and where the custodian resides. The alternative to quarantining (to include home confining) a dog, cat, or domestic ferret is to have the animal humanely killed in such a manner that the brain is not damaged and a suitable specimen (head with brain intact or brain) submitted to a department-designated laboratory for rabies testing as specified in subsection (h) of this section. To allow home confinement, the following criteria must be met.

(1) (No change.)

(2) The animal has been vaccinated against rabies and the time elapsed since the most recent vaccination has not exceeded the manufacturer [ label ] recommendations for the vaccine. If an unvaccinated animal is not over 16 weeks [ four months ] of age at the time of the potential exposure [ bite ], it may be allowed home confinement [ quarantine ].

(3) The local rabies control authority or a [ licensed ] veterinarian must observe the animal at least on the first and last days of the home confinement [ quarantine period ].

(4) The animal was not a stray [ ( ]as defined in the Texas Health and Safety Code, §826.002[ ) ] , at the time of the potential exposure [ bite ].

(b) A domestic animal which has potentially exposed a human and has been designated by the local rabies control authority as unowned may be humanely killed. A suitable specimen shall be submitted for rabies testing as specified in subsection (h) of this section. [ A domestic animal which has bitten a human and has been designated by the local rabies control authority as unclaimed may be humanely killed in such a manner that the brain is not mutilated. A suitable specimen (head with brain intact or brain) shall be submitted to a department certified laboratory for rabies diagnosis as specified in subsection (h) of this section. ]

(c) If the animal implicated in the potential exposure [ biting animal ] is a high - risk animal, it shall be humanely killed and a suitable specimen submitted for rabies testing as specified in subsection (h) of this section.

(d) If the [ biting ] animal implicated in the potential exposure is a low - risk animal, neither quarantine nor rabies testing will be required unless the local rabies control authority has cause to believe the [ biting ] animal is rabid, in which case it shall [ should ] be humanely killed and a suitable specimen submitted for rabies testing as specified in subsection (h) of this section.

(e) (No change.)

(f) If the [ biting ] animal implicated in the potential exposure is not included in subsection (a), (b), (c), (d), or (e) of this section, the [ biting ] animal will be humanely killed and a suitable specimen submitted for rabies testing as specified in subsection (h) of this section or the local rabies control authority may require the animal to be quarantined at a department-licensed quarantine facility or a veterinary clinic, or confined elsewhere as deemed appropriate by the local rabies control authority [ or suitably confined ] for the 30-day observation period as an alternative [ alternate method ] to killing and testing. If the potential rabies exposure occurs in a city or county other than where the animal's custodian resides, the animal may be transferred to a department-licensed quarantine facility or a veterinary clinic in the city or county of the custodian's residence or allowed confinement deemed appropriate if there is mutual agreement to do so between the local rabies control authorities for the city or county where the exposure occurred and where the custodian resides.

(g) Any animal required to be quarantined under this section, which cannot be maintained in [ a ] secure quarantine, shall be humanely killed and a suitable specimen submitted for rabies testing as specified in subsection (h) of this section.

(h) All laboratory specimens referred to in subsections (a) - (g) [ (b)-(g) ] of this section shall be submitted in accordance with §169.33 of this title (relating to Submission of Specimens for Laboratory Examination).

(i) At the discretion of the local rabies control authority, [ currently vaccinated ] assistance animals [ , therapy, and police dogs ] may not be required to be placed in quarantine (to include confinement) during the observation period.

(j) Police service animals are exempted from quarantine per the Texas Health and Safety Code, §826.048, including confinement.

(k) Animals should not be vaccinated against rabies during the observation period; however, animals may be treated for unrelated medical problems diagnosed by a veterinarian. If the animal becomes ill during the observation period, the local rabies control authority must be notified by the person having possession of the animal.

§169.28.Requirements of a Quarantine Facility.

(a) Quarantine procedures.

(1) A quarantine facility [ Quarantine facilities ] shall have and use written standard operating procedures (SOP) specific for that facility to ensure effective and safe quarantine procedures. The SOP shall be posted in the quarantine facility , or otherwise be readily available to all employees in the quarantine facility, and adhered to by each employee.

(2) An animal being quarantined because it [ which ] may have exposed a human to rabies [ and animals suspected of rabies that are placed in quarantine for observation ] must be maintained in a primary enclosure, separated from all other animals by a solid partition [ from all other animals in such a manner ] so that there is no possibility of physical contact between animals. An empty chamber between animals is not an acceptable alternative. To prevent rabies transmission, handling of rabies-suspect animals shall be minimized and carried out in a manner that avoids physical contact of other animals and people with the saliva of quarantined animals. Individuals handling animals suspected of shedding rabies virus should utilize appropriate personal protective equipment. To prevent escape, the primary enclosure [ chamber ] must be enclosed on all sides, including the top. Quarantine cages, runs, or rooms must have "Rabies Quarantine" signs posted.

[ (3) Unowned animals may be destroyed for rabies diagnosis prior to the end of the quarantine period. ]

(b) Facilities planning. Any entity [ county, city, town, or incorporated community ] desiring to construct a [ animal ] quarantine facility [ facilities ] shall submit plans to the department for review prior to beginning construction [ approval ].

(c) Inspection requirements of quarantine facilities.

(1) It will be the responsibility of the department to inspect all [ animal ] quarantine facilities , including those operated by government contractors . The inspection of the premises will be accomplished during ordinary business hours. All deficiencies will be documented in writing. Those that are of sufficient significance to affect the humane care or security of any animal housed within [ confined to ] the facility must be corrected within a reasonable period of time.

(2) (No change.)

(3) The quarantine facility manager has the right to appeal the results of the inspection [ evaluation ]. If the opinion of management of the quarantine facility is in conflict with the inspection [ evaluation ], he or she may request a review of the inspection by the manager [ director ] of the department's Zoonosis Control Branch. [ Zoonosis Control Division. In the event points of difference still remain, the supervisor may request a review of the inspection by the chief of the department's Bureau of Communicable Disease Control. ] The appeal [ Each of the appeals ] listed in this paragraph [ , when required, ] will be made in writing through the regional director's office of the health service [ public health ] region in which the quarantine [ animal ] facility is located.

§169.29.Vaccination Requirement.

(a) The [ owner or ] custodian (excluding animal shelters as defined in the Texas Health and Safety Code, §823.001 ) of each [ domestic ] dog or cat shall have the animal vaccinated against rabies by 16 weeks [ four months ] of age. The animal must be vaccinated by or under the direct supervision of a veterinarian with rabies vaccine licensed by the United States Department of Agriculture for that animal species at or after the minimum age requirement and using the recommended route of administration for the vaccine. The attending veterinarian has discretion as to when the subsequent vaccination will be scheduled as long as the revaccination due date does not exceed the recommended interval for booster vaccination as established by the manufacturer or vaccination requirements instituted by local ordinance. The custodian shall retain each vaccination certificate until the animal receives a subsequent booster. [ The animal must receive a booster within the 12-month interval following the initial vaccination. Every domestic dog or cat must be revaccinated against rabies at a minimum of at least once every three years with a rabies vaccine licensed by the United States Department of Agriculture. The vaccine must be administered according to label recommendations. ] Livestock (especially those that have frequent contact with humans), domestic ferrets, and wolf-dog hybrids should be vaccinated against rabies. The administration of a rabies vaccine in a species for which no licensed vaccine is available is at the discretion of the veterinarian; however, an animal receiving a rabies vaccine under these conditions will not be considered to be vaccinated against rabies virus in potential rabies exposure situations. [ Nothing in this section prohibits a veterinarian and owner or custodian from selecting a more frequent rabies vaccination interval. Health and Safety Code, §§826.014 and 826.015 allow local jurisdictions to establish more frequent rabies vaccination intervals. ]

(b) An official [ Official ] rabies vaccination certificate [ certificates ] shall be issued for each animal by the [ vaccinating ] veterinarian responsible for administration of the vaccine and contain the following information:

(1) custodian's [ owner's ] name, address, and telephone number;

(2) - (4) (No change.)

(5) revaccination due date [ date vaccination expires (revaccination due date) ];

(6) (No change.)

(7) veterinarian's signature , [ or ] signature stamp , or computerized signature, plus address, phone number, and license number.

(c) Each veterinarian who issues a rabies vaccination certificate, or the veterinary practice where the certificate was issued, shall retain a readily retrievable copy of the certificate [ A copy of each rabies vaccination certificate issued shall be retained by the issuing veterinarian and be readily retrievable ] for a period of not less than two years after the revaccination due date [ five years from the date of issuance ].

(d) (No change.)

§169.30.Disposition of Domestic Animals Exposed to Rabies.

(a) Not currently vaccinated animals which have been bitten by, directly exposed by physical contact with, or directly exposed to the fresh tissues of a high-risk animal that is either unavailable for testing or for which a negative test cannot be confirmed or a rabid animal [ or directly exposed by physical contact with a rabid animal or its fresh tissues ] shall be:

(1) (No change.)

(2) [ if sufficient justification for preserving the animal exists, the exposed animal shall be ] immediately vaccinated against rabies, placed in confinement [ strict isolation ] for 90 days, and given booster vaccinations during the third and eighth weeks of confinement [ isolation ]. For young animals, additional vaccinations may be necessary to ensure that the animal receives at least two vaccinations at or after the age prescribed by the United States Department of Agriculture (USDA) for the vaccine administered.

(b) Currently vaccinated animals which have been bitten by, directly exposed by physical contact with, or directly exposed to the fresh tissues of a high-risk animal that is either unavailable for testing or for which a negative test cannot be confirmed or a rabid animal [ or otherwise significantly exposed to a rabid animal ] shall be:

(1) (No change.)

(2) immediately [ if sufficient justification for preserving the animal exists, the exposed vaccinated animal shall be ] given a booster rabies vaccination [ immediately ] and placed in confinement [ strict isolation ] for 45 days.

(c) These provisions apply only to domestic animals for which a USDA-licensed [ an approved ] rabies vaccine is available.

(d) In situations where none of the requirements of this section are applicable, the recommendations contained in the latest edition of the publication titled The Compendium of Animal Rabies Control, published by the National Association of State Public Health Veterinarians, should be followed. The administration of a rabies vaccine in a species for which no licensed vaccine is available is at the discretion of the veterinarian; however, an animal receiving a rabies vaccine under these conditions will not be considered to be vaccinated against rabies virus in potential rabies exposure situations.

§169.31.Interstate Movement of Dogs and Cats into Texas.

Each dog and cat 12 weeks [ over three months ] of age or older to be transported into Texas for any purpose shall be admitted only when vaccinated against rabies and the time elapsed since the most recent vaccination has not exceeded the manufacturer [ label ] recommendations for the vaccine. If an initial vaccination was administered less than 30 days prior to arrival, the custodian should confine the dog or cat for the balance of the 30 days. Additionally, documentation [ identification ] must be provided by a vaccination certificate showing the date of vaccination, vaccine used, and signature of the [ licensed ] veterinarian responsible for administration of the vaccine [ who administered the vaccine ]. If the dog or cat is less than 12 weeks of age, the custodian should confine the animal until 30 days subsequent to its initial vaccination.

§169.32.International Movement of Dogs and Cats into Texas.

The federal government regulates the entry of pets into the United States; requirements set forth in this section are in addition to meeting federal requirements. Each dog and cat 12 weeks [ over three months ] of age or older to be transported into Texas for any purpose shall be admitted only when vaccinated against rabies and the time elapsed since the most recent vaccination has not exceeded the manufacturer [ label ] recommendations for the vaccine. If an initial vaccination was administered less than 30 days prior to arrival in the United States, the custodian must confine the dog or cat for the balance of the 30 days. Additionally, documentation [ identification ] must be provided by a vaccination certificate showing the date of vaccination, vaccine used, and signature of the veterinarian responsible for administration of the vaccine [ who administered the vaccine ]. Any dog or cat that has received a rabies vaccine not licensed by the United State Department of Agriculture or has been vaccinated under the authority of a veterinarian who was not licensed to practice veterinary medicine in the United States may be admitted but must be vaccinated according to Texas requirements within 30 days after entering Texas. If the dog or cat is less than 12 weeks of age, the custodian must confine the animal until 30 days subsequent to its initial vaccination. [ International movement of dogs and cats into Texas will also include any rules and regulations prescribed by the United States government. ]

§169.33.Submission of Specimens for Laboratory Examination.

Preparation of specimens either for shipment or for personal delivery for rabies diagnosis shall include the following.

(1) (No change.)

(2) The head of the suspect animal shall be separated from the body by a qualified person as soon as possible [ immediately ] after the death of the animal [ by a qualified person ]. Only the head shall be submitted with the exception that whole bats and small rodents may be submitted. If only the brain is submitted rather than the entire head, the minimum tissue requirements for rabies testing are a complete transverse cross section of the brain stem and tissue from one of the following: cerebellum or hippocampus [ parts of the cerebellum, hippocampus, and brain stem must be included ]. Submissions that do not meet these tissue requirements [ Specimens which do not include at least two of these three areas of the brain ] will be considered unsatisfactory due to a lack of sufficient material.

(3) The specimen [ head ] shall be immediately chilled to between 32 [ 45 ] degrees Fahrenheit and 45 [ 32 ] degrees Fahrenheit either in a refrigerator or by packing for shipping with sufficient amounts of refrigerants in the container ; the specimen [ .The head ] should not be frozen. When shipping, sufficient refrigerant shall be added so the specimen will remain chilled for a minimum of 48 hours. Do not use dry ice. Gel packs or similar refrigerants are recommended. Ice is not recommended.

(4) If specimens are shipped, containment in compliance with requirements in the Code of Federal Regulations (CFR), Title 49, [ two containers ] shall be used for packing. Packing methods shall prevent leakage and provide for proper identification (such as an identification number) of the specimen.

[ (A) The immediate (inner) container. Only one head shall be placed in each immediate container which shall be double plastic bags. Attach the owner's name or an identification number to each double-sealed plastic bag. Adhesive tape is useful. Do not use masking tape. ]

[ (B) The shipping (outer) container. ]

[ (i) The immediate container(s) shall be placed in an insulated shipping container of adequate strength to withstand shipping conditions, such as a styrofoam container inside a cardboard box. ]

[ (ii) Sufficient refrigerant shall be added so the head will remain chilled for a minimum of 48 hours. Do not use dry ice. Gel packs or similar refrigerants are recommended. Ice is not recommended but, if used, must be doubled-bagged in heavy-duty plastic bags. ]

[ (iii) Packing material, such as newspaper, shall be added to absorb water and blood in the event of leakage and buffer the specimens. ]

(5) [ (iv) ] A completed department [ Texas Department of Health ] Form G-9, Rabies Submission Form, which is available at the department's Laboratory Services Section, Department of State Health Services [ Bureau of Laboratories, Texas Department of Health ], 1100 West 49th Street, Austin, Texas 78756, is required for each specimen [ head ] submitted to the department's Laboratory Services Section . Each form must contain the same identification information provided with the specimen [ as located on the specimen bag ] as stated in paragraph (4) of this section [ subparagraph (A) of this paragraph ]. Submission form(s) shall be contained [ placed ] in a water-proof bag [ on top of the Styrofoam container inside the cardboard box. If a combination of a Styrofoam container and cardboard box is not used, the form(s) shall be placed on top of the packing material inside the outer container ].

(6) [ (v) ] Labeling on the outside of the shipping container shall be legible and include:

(A) [ (I) ] name, address, and telephone number of the [ appropriate ] laboratory [ (listed in paragraph (6) of this section) ];

(B) [ (II) ] name, [ the ] return address, [ name, ] and telephone number of the shipper; [ and ]

(C) language in compliance with requirements in the CFR, Title 49, pertaining to the shipment of infectious substances for diagnostic purposes; and

(D) [ (III) ] the following information [ statement ]: "RABIES IDENTIFICATION TEAM, LABORATORY SERVICES SECTION - REFRIGERATE ON ARRIVAL." [ "RABIES SUSPECT - REFRIGERATE ON ARRIVAL." ]

(7) [ (5) ] The following procedures are required for shipment:

(A) shipment shall be by bus or other reliable carrier; the department does not recommend the United States Postal Service. If an overnight carrier is used, such as United Parcel Service (UPS) or Federal Express, ship the specimen such that it will arrive by Friday or delay shipment until Monday. These services do not deliver to the department on the weekend;

(B) a shipping receipt will be obtained and retained by the shipper;

(C) at the time of the shipment, the shipper shall telephone the [ appropriate ] laboratory and notify laboratory personnel of the shipment; and

(D) the shipper shall provide the return postage (in the form of stamps, not money) if return of the shipping container is desired.

(8) Paragraphs (5) and (6) of this section apply to specimens submitted to the department's Laboratory Services Section. The appropriate form, labeling instructions, and shipping requirements for another department-designated laboratory can be obtained by contacting that laboratory; a list of these laboratories with their contact information will be maintained on the department's website.

[ (6) The certified laboratories in Texas are: ]

[ (A) Austin - Bureau of Laboratories, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, telephone the rabies shipment notification hotline at 1-800-252-8163, or the local telephone at: (512) 458-7595, (512) 458-7515, or (512) 458-7491. ]

[ (B) El Paso - Laboratory, El Paso City-County Health Department, 222 South Campbell, El Paso, Texas 79901, telephone: (915) 543-3536; ]

[ (C) Houston - Bureau of Laboratory Services, City of Houston Health Department, 1115 South Braeswood, Houston, Texas 77030, telephone: (713) 558-3468 or (713) 558-3467; ]

[ (D) San Antonio - Laboratory, San Antonio Metropolitan Health District, 332 West Commerce Street, Room 203, San Antonio, Texas 78205, telephone: (210) 207-8884. ]

§169.34.Statewide Quarantine.

(a) Declaration. The Executive Commissioner of the Health and Human Services Commission (HHSC) [ board ] declares a statewide rabies quarantine.

(1) - (2) (No change.)

(3) Animals subject to the statewide rabies quarantine include any live species of foxes indigenous to North America, coyote ( Canis latrans ) [ (Canis latrans) ], or raccoon ( Procyon lotor ) [ (Procyon lotor), or species of foxes indigenous to North America ].

(4) Transport exceptions. Animals subject to the statewide rabies quarantine may be transported by peace officers and individuals hired or contracted by local, state, or federal government agencies [ state or federal agencies or local governments ] to deal with stray animals when such transport is a part of their official duty. These animals may also be transported by employees of zoos or other institutions accredited by the American Association of Zoological Parks and Aquariums when such transport is part of their official duty. If an exempt individual transports such animals for release, the animals must be released within a ten-mile radius or within ten miles of the city limits of where they were originally captured.

(b) Executive Commissioner of the HHSC's [ Board's ] designee. The Executive Commissioner of the HHSC's [ board's ] designee is the commissioner of the Department of State Health Services , whom the Executive Commissioner of the HHSC [ board ] appoints to act as his or her [ its ] designee as described in the Texas Health and Safety Code, §826.045.

(c) - (d) (No change.)

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 August 20, 2007.

TRD-200703752

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 30, 2007

For further information, please call: (512) 458-7111 x6972