TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 83. INNOVATION GRANTS

The Texas Department of Health (department) adopts new §§83.1 - 83.13 and 83.20 - 83.30 relating to the creation of innovation grants for essential public health services and for capital improvements in small urban hospitals. Sections 83.2, 83.3, 83.5 - 83.8, 83.10, 83.11, 83.21, 83.23, 83.26, and 83.28 are adopted with changes to the proposed text as published in the October 29, 1999 issue of the Texas Register (24 TexReg 9527). Sections 83.1, 83.4, 83.9, 83.12, 83.13, 83.20, 83.22, 83.24, 83.25, 83.27, 83.29, and 83.30 are adopted without changes, and therefore the sections will not be republished.

These rules are adopted to implement a portion of Acts 1999, 76th Legislature, Chapter 1391 (House Bill (HB) 1676), which creates the Permanent Fund for Children and Public Health and the Community Hospital Capital Improvement Fund. In addition, these rules are adopted to implement a portion of Acts 1999, 76th Legislature, Chapter 1378 (House Bill (HB) 1444), which establishes grants for essential public health services.

House Bill 1676 enacts the Government Code, §403.1055 which allows the earnings of the Permanent Fund for Children and Public Health to be appropriated to the department, for: (1) developing and demonstrating cost-effective prevention and intervention strategies for improving health outcomes; (2) providing grants to local communities to address specific public health priorities; and (3) providing grants to local communities for essential public health services as defined in the Health and Safety Code.

House Bill 1444 amends the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121. House Bill 1444 enacts the Health and Safety Code, §121.002 which defines essential public health services. House Bill 1444 also enacts the Health and Safety Code, §121.0065 which describes grants for essential public health services. The third part of the Permanent Fund for Children and Public Health in HB 1676 refers to the grant program authorized under HB 1444.

House Bill 1676 also enacts the Government Code, §403.1066 which creates the Community Hospital Capital Improvement Fund. House Bill 1676 allows the earnings of this fund to be appropriated to the department for providing grants, loans, or loan guarantees to small, urban public or private nonprofit community hospitals for capital improvements. The department will only award grants because of the projected administrative cost of providing loans or loan guarantees.

The sections are adopted to accomplish the following: define terms in the legislation, provide the department's philosophy in making the grants, discuss the sources and allocation of funds, establish who is eligible to receive the grants, provide the requirements for receiving the grants, establish the procedures for grant announcements, establish the procedures for grant applications, describe the competitive review process, and outline the selection criteria for awarding grants.

Concerning Subchapter A: Permanent Fund for Children and Public Health, the department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning the definition of closing date in §83.2(1), the words "or postmarked" were added to clarify the definition.

Change: Concerning §83.2(6), a definition of "minority populations" was added. The addition of the definition resulted in a renumbering of the definitions.

Change: Concerning §83.3(b), two changes were made. The phrase "for children and the public" was deleted because it was not needed. In addition, language was added to state that the innovations funded by the grants should be replicable in other parts of Texas. Replicability had been discussed with stakeholders prior to the public comment period but was inadvertently left out of the proposed rules.

Change: Concerning proposed §83.3(c), the department has chosen to delete this part of the philosophy section stating that the department intends that the grants shall be consistent with the department's vision, mission, and strategic plan. The department's selection criteria in §83.11 are a clearer statement of the funding desires of the department.

Change: Concerning new §83.3(c), the department changed the wording so that the statement says that grants are intended to bring about health status improvements that are demonstrable or measurable instead of demonstrable and measurable. The language "demonstrable or measurable" is also consistent with §83.11(a)(2).

Change: Concerning §83.5(f), the wording was simplified for clarity.

Change: Concerning §83.6(a)(2) and §83.6(a)(3), the words "in Texas" were added to the list of eligible grantees to clarify that grantees must be Texas entities.

Change: Concerning §83.7(d), "Part III" was added to clarify that the second sentence of this section was also addressing only Part III grants.

Change: Concerning §83.8(c)(3), language was added to clarify that there will be a maximum (and minimum) amount of money awarded for individual grants as well as for individual grantees.

Change: Concerning §83.10(b), the words "or potential" were deleted to clarify that the reviewers must only not be applicants in the request for proposal or other competitive process under consideration, not for all future competitive processes.

Change: Concerning §83.11(b)(1), language was added to state that the innovations funded by the grants should be replicable in other parts of Texas. Replicability had been discussed with stakeholders prior to the public comment period but was inadvertently left out of the proposed rules.

Change: Concerning §83.11(b)(2), language concerning obtaining and addressing community needs was added to make this criteria explicit in the section.

Change: Concerning §83.11(b)(4), the phrase "one or more" was added for clarification.

Change: Concerning §83.11(b)(6), the phrase, "such as publication in the public health or medical literature" was deleted. This example will be in the request for proposal instead, along with other possible dissemination methods.

Change: Concerning §83.11(b)(7), this preference was reworded to clarify the emphasis on strengthening essential public health services infrastructure.

Concerning Subchapter A: Permanent Fund for Children and Public Health, the following comments were received concerning the proposed sections. Following each comment are the department's response and any resulting changes.

Comment: Concerning the definitions of urban and rural areas, §83.2(8) and (9), one commenter suggested using the following definition for rural: "rural county means: (a) a county that has a population of 50,000 or less according to the most recent U.S. census; or (b) with respect to a county that has a population of more than 50,000 and that contains a geographic area that is not delineated as urbanized by the federal census bureau, that part of the county that is not delineated as urbanized."

Response: The department disagrees. The department used the definition from HB 1676 where it enacts Government Code, §106.201. Although that section relates to grants or loan programs administered by the Center for Rural Health Initiatives, the department believes that the definition in the rules is easily understandable and equitable. The department recognizes that there are many different statutory definitions for urban and rural areas. No change was made as a result of this comment.

Comment: Concerning §83.3(a) and §83.11(b)(1) four commenters suggested that the department should not focus on innovation. One commenter suggested that the preference for innovation should apply to Part I grants only.

Response: The department disagrees. Because of limited funding, the department must leverage grant funds and focusing on innovations is one way of accomplishing this. In addition, §83.11(b)(1) is a preference not a requirement for grant applications. However, in response to these comments, the department has added a definition of innovation in §83.2. Sections 83.3(b) and 83.11(b)(1) were modified to reflect the inclusion of the definition of innovation. The addition of the definition also resulted in a renumbering of the definitions.

Comment: Concerning §83.6(a)(1), five commenters suggested that the department should not be eligible to receive Part I grants.

Response: The department agrees with the commenters and has modified §83.6(a)(1) to delete the eligibility of the department to receive Part I grants. The department also removed §83.10(c) which described the competitive review process when the department applied for a Part I grant.

Comment: Concerning the proportion of funds to be allocated to grants for each part, §83.5(e), two commenters suggested that the funds should be distributed in equal amounts among the three parts.

Response: The department disagrees. The department believes that some flexibility in awarding grant funds among the three parts is necessary to be able to focus funds on the best proposals. No change was made as a result of this comment.

Comment: Concerning the division of Part III funds among urban and rural areas of the state, §83.5(f), one commenter suggested that the section should read, "grants made under Part III shall be allocated in a manner which reflects the geographical distribution of Texas citizens or the demand for public health programs and services in the state."

Response: The department disagrees. The department believes that the wording of this section is true to the legislative intent of HB 1444 which requires that Part III grants be distributed equally between urban and rural areas of the state. No change was made as a result of this comment.

Comment: Concerning eligibility for grants, §83.6(a), one commenter suggested that counties, municipalities, public health districts and political subdivisions should not be eligible for grants.

Response: The department disagrees. For Part III grants, HB 1444 delineates that the persons listed in §83.6(a)(3) may receive the grants. For Part I and II grants, the department believes that the list of eligible applicants correctly captures the intent of HB 1676 which states that local communities may receive Part II grants but places no limit on Part I grantees. No change was made as a result of this comment.

Comment: Concerning the requirements for grants, §83.7 (a), one commenter suggested that the rules should contain more details about the reasonable requirements for the grants.

Response: The department disagrees. The department believes the rules should be broad and flexible with details in the requests for proposals. However, the department intends to post for comments the draft request(s) for proposals on the innovation grants website at http://www.tdh.state.tx.us/innovation . No change was made as a result of this comment.

Comment: Concerning the requirements for grants, §83.7(d), two commenters suggested deleting the requirement that grant recipients under Part III must have a local health authority who is not the department's regional director.

Response: The department disagrees. House Bill 1444 requires a Part III grantee to appoint a health authority. HB 1444 and the Local Public Health Reorganization Act in §121.007 only allow a department regional director to serve as a health authority in the absence or incapacity of the jurisdiction's appointed health authority. No change was made as a result of this comment.

Comment: Concerning the department's training session for applicants, §83.8(d), one commenter suggested that the training sessions not be required for applicants.

Response: The department agrees and has modified the section to state that the training sessions are optional.

Comment: Concerning the training session(s) offered by the department to applicants, §83.8(d), one commenter suggested additional wording stating that the department will in no way consult or advise on the writing or otherwise review any grant before its submission and that the department will offer technical assistance equally to both urban and rural areas of the state.

Response: The department disagrees. The department does not believe that this wording is necessary in the rules. However, the department pledges to offer technical assistance, to the extent possible with available funding, to all interested parties. No change was made as a result of this comment.

Comment: Concerning review of applications, §83.10(b), one commenter suggested that the department create a standing advisory board to evaluate grant applications, give input regarding grant priorities, hear public comment and provide technical expertise.

Response: The department disagrees. The department prefers to maintain the Commissioner of Health's discretion in inviting advisors to participate in the grant process. No change was made as a result of this comment.

Comment: Concerning the selection criteria, §83.11(a)(1), one commenter suggested that all projects funded be consistent with accomplishing the provision of essential public health services.

Response: The department agrees. However, the department believes that the section is worded appropriately to accomplish this recommendation. No change was made as a result of this comment.

Comment: Concerning the selection criteria, §83.11(a)(1), three commenters suggested that the requirement that all applications address one or more of the essential public health services should be deleted because direct services should be funded through this grant program.

Response: The department disagrees. The department's focus in the grant program is on essential public health services as defined in the rules. To clarify this intent, a statement was added in §83.3(d) stating that grant funds will not be used to fund direct health care services except when those services are incidental to an essential public health service being addressed.

Comment: Concerning the selection criteria, §83.11(b), four commenters suggested adding a preference for applications that address issues related to children.

Response: The department disagrees. The department believes that public health innovations funded will address public health concerns for all Texans, including children. No change was made as a result of this comment.

Comment: Concerning selection criteria, §83.11(b)(3) one commenter suggested that matching funds should include those funds that are being or can be used for the provision of essential public health services by applicants. The commenter stated that "matching funds" should not necessarily mean the acquisition>

Response: The department agrees. The preference has been reworded to clarify that the preference addresses the commitment on the part of the applicant to spend future funds obtained by the applicant, in addition to the grant funds, during the grant period. The future funds may be a continuation of funds the applicant currently spends on essential public health services.

Comment: Concerning the selection criteria, §83.11(b)(3), one commenter suggested that the preference for matching funds or in-kind contributions be deleted.

Response: The department disagrees. Since the funding for innovation grants is limited, this selection preference is important to help ensure a broad provision of services, but, the preference is written broadly so that applicants can meet this preference in a number of ways. No change was made as a result of this comment.

Comment: Concerning the selection criteria, §83.11(b)(4), one commenter suggested that a preference for addressing underlying causes be eliminated.

Response: The department disagrees. The department believes that, in order to fully address public health problems, an understanding of their underlying causes is crucial. Projects funded through innovation grants should promote this understanding. No change was made as a result of this comment.

Comment: Concerning the selection criteria, §83.11(b)(8), four commenters suggested that the preference for a local board of health be removed.

Response: The department agrees in part. The department believes that local boards of health can be valuable in administering local public health. However, in deference to the commenters, the department has revised the preference to broaden the language to a preference for "local health boards or other appropriate advisory groups."

Concerning Subchapter B: Community Hospital Capital Improvement Fund, the department is making the following changes due to staff comments to clarify the intent and improve the accuracy of these sections.

Change: Concerning the definition of closing date, §83.21(1), the words "or postmarked" were added to clarify the definition.

Change: Concerning §83.21, paragraph (6) has been inserted to define essential public health services as defined in the Health and Safety Code, §121.002(1). The existing paragraph (6) has been renumbered (7). Paragraph (8) has been inserted to define rural area. The existing paragraph (8) has been renumbered (9). The definition of urban area has been modified accordingly so as not to conflict with the rural area definition.

Change: Concerning §83.23(a), the first sentence has been revised to read, "A public or private nonprofit community hospital licensed for 125 beds or fewer located in an urban area is eligible to apply for a grant." "Private" was inserted to clarify that both public and private nonprofit hospitals are eligible. "Licensed for" was inserted to clarify that the number of licensed beds, not the number of beds in operation, is a criterion for eligibility.

Concerning Subchapter B: Community Hospital Capital Improvement Fund, the following comments were received concerning the proposed sections. Following each comment are the department's response and any resulting change(s).

Comment: Concerning the definition of capital improvement in §83.21, a commenter requested that the definition be amended to expressly include information system hardware and software purchases.

Response: The department agrees and added modified language to the definition.

Comment: Concerning §83.22 regarding the sources and allocation of funds, a commenter agreed that the initial program should be limited to grants because of the administration expense cap. However, the commenter requested that, if additional funding increases program resources, the department should reconsider limiting the program to grants and offer loan and loan guarantee options with the input of stakeholders.

Response: The department agrees in part with the commenter. The program will only be awarding grants due to the expense involved in administering loans. Expansion beyond grants is not foreseen at this time but if changes are made to these sections, stakeholder input will be obtained. No change was made as a result of this comment.

Comment: Concerning the requirements for grants in §83.24(a), a commenter noted that community hospitals have limited resources to devote to grant writing and requested the convening of a stakeholder group discussion to ensure the department receives public input regarding the operational implications of grant application requirements.

Response: The department agrees in part with the commenter. In preparing the request for proposal (RFP) to solicit grant applications, the fact that community hospitals may be limited in their grant writing resources was taken into consideration. The department made every effort to keep requirements in the RFP to a minimum. The need to issue the RFP in a timely manner precluded the convening of a stakeholder group. However, after the grants are awarded, the department intends to contact each eligible recipient to solicit their comments regarding the RFP process. No change was made as a result of this comment.

Comment: Concerning §83.24(c), a commenter questioned the need for an annual report since a contract with the department will be executed with facilities receiving grant dollars, and contract items include reporting requirements. The commenter feels additional reporting requirements are burdensome and unnecessary and should be established in advance of program implementation.

Response: The department disagrees with the commenter. The department must make an annual report to the Legislative Budget Board on the permanent funds. The recipients' reports will assist the department in preparing its own report. The annual report is not an additional reporting requirement in that the reporting section of the general provisions in departmental contracts state that "PERFORMING AGENCY shall provide RECEIVING AGENCY other reports . . . RECEIVING AGENCY determines necessary to accomplish the objectives of this contract." In addition, all reporting requirements will be determined prior to program implementation and will be included in the contract. No change was made as a result of this comment.

Comment: Concerning §83.25, a commenter took exception to addressing grant requirements through a request for proposal (RFP) process. Rather, grant criteria should be established through the rulemaking process to ensure adequate input from the public and community hospital facilities. In addition, the commenter agreed that the department should maintain a list of persons to be notified of RFPs and suggested that this list include health care organizations.

Response: The department disagrees with the commenter. As a program evolves and experience is gained from funded projects, grant criteria may need to be revised accordingly. If the criteria are included in the rules, as opposed to the RFP, the rules would have to be amended each time a change is made in the criteria. This would place an undue burden upon the department. In addition, the department will maintain a list of applicants to be notified of the RFP, but this list will only include the eligible community hospitals, the Texas Hospital Association, the Texas Association of Public Hospitals, and not health care organizations in general. No change was made as a result of this comment.

Comment: Concerning the procedures for grant applications in §83.26, a commenter expressed the need for grant requirements to accommodate the limited resources and technical skills of eligible entities and requested a formal process to provide feedback regarding the grant requirements.

Response: The department agrees with the commenter and made every effort to keep requirements in the RFP to a minimum. After the grants are awarded, the department intends to contact each eligible recipient to solicit their comments regarding the RFP process. No change was made as a result of this comment.

Comment: Concerning §83.26(b), a commenter noted that the department is not required to provide training regarding the completion of a grant application in response to the request for proposal (RFP). Without the availability of technical assistance, the commenter requested that the department be required by rule to give written guidance as to the nature or cause of a grant application's incompleteness or inconsistency with program requirements. The commenter further asked that consideration be given to the ability of those entities to reapply for a grant within a specified time period.

Response: The department agrees in part with the commenter. The term "inconsistent" is vague. Subsection (b) has been modified to read "Applications that are substantially incomplete according to the requirements of this subchapter may be rejected without further consideration at the discretion of the department." Although not specified in the rules, the RFP clearly identifies items that must be included in the grant application along with a checklist. After the department receives an application and performs an initial cursory review, applicants who may have inadvertently omitted some item(s) will be contacted to ascertain whether the item(s) can be forwarded to the department in a timely manner. The department supports its right to reject applications that are "substantially incomplete." In addition, unsuccessful applicants will not be given an opportunity to reapply until the following RFP cycle. No further changes were made as a result of this comment.

Comment: Concerning §83.27(b), since the department is given sole discretion to approve or deny applications and determine program requirements, a commenter suggested the appointment of a volunteer advisory board or committee to provide another mechanism for stakeholder input.

Response: The department disagrees with the commenter. The request for proposal for the 200/2001 biennium under this grant program was issued November 19, 1999. Since, after the grants are awarded, the department intends to contact each eligible recipient to solicit their comments regarding the RFP process, the establishment of a separate advisory board or committee would be duplicative. No change was made as a result of this comment.

Comment: Concerning the competitive review process in §83.27, a commenter recommended requiring the department to establish by rule the creation of a group of advisors to review and make recommendations concerning the grant process. In addition, the group's composition should be addressed through the rulemaking process.

Response: The department disagrees with the commenter. Subsection (b) states that the department may invite advisors from inside or outside the department to provide review and make recommendations concerning the grant process. The department feels that the identification of the composition of the advisory group would restrict the department in the future from obtaining advice on a particular request for proposal from persons with appropriate background or knowledge. No change was made as a result of this comment.

Comment: Concerning the selection criteria in §83.28(b), a commenter disagreed with the inclusion of subsection (b) which states the department will give preference to grant applications that are directed toward capital improvements related to public health purposes. It is the commenter's opinion that preference for public health-related capital improvements is not contemplated by HB 1676. In addition, some grant applicants with critical capital needs would be placed at a disadvantage because their proposal did not address a public health purpose even if other expenditures had been made to support and/or provide for community public health needs.

Response: The department disagrees with the commenter. The title of HB 1676, which authorizes the Community Hospital Capital Improvement Fund, is "AN ACT relating to permanent funds for certain public health purposes." It is the department's contention that the legislative intent of the provisions contained in HB 1676 includes the funding of projects directed toward improving public health in Texas. Capital improvement projects that are not related to public health will not be summarily rejected. Rather, preference will be given to capital improvements related to an essential public health service. The language in §83.28(b) has been modified to clarify this preference.

On August 25, 1999, the department held a stakeholder meeting regarding the innovation grants. More than 30 individuals volunteered to closely review and comment on the draft proposed rules prior to Board consideration. The draft proposed rules and the proposed rules were posted on the department web site (http://www.tdh.state.tx.us/innovation). The draft final rules and the final rules will be posted on the website also. The draft proposed rules were considered by the Texas Association of Local Health Officials (TALHO) board on October 7, 1999, and by the Commissioner's Council on Local Public Health (CCLPH) on October 8, 1999. The draft final rules were considered by TALHO at their general meeting on December 9, 1999, and by CCLPH at their December 10, 1999, meeting. TALHO and CCLPH members agreed to inform their constituents about the proposed rules and solicit feedback.

The comments on the proposed rules received by the department during the comment period were submitted by: Children's Hospital Association of Texas, Texas Planning Council for Developmental Disabilities, Center for Public Policy Priorities, Texas Hospital Association, TALHO, CCLPH, Texas Medical Association, the Fort Bend County Judge, the Harris County Judge, the Jefferson County Judge, the director of the City of Houston Health and Human Services, and several individuals. The department made presentations to several groups about the rules including two presentations to the local health directors in region 2/3 and a presentation to the Texas Health Coalition. The department responded to numerous inquiries about the proposed rules. Department program staff solicited feedback on the proposed rules from stakeholders of their particular programs.

Overall, groups and individuals who reviewed the draft proposed rules and the posted proposed rules were satisfied with their content. However, several commenters raised questions, offered comments for clarification purposes and suggested clarifying language concerning specific provisions in the rules as discussed in the summary of comments.

Subchapter A. PERMANENT FUND FOR CHILDREN AND PUBLIC HEALTH

25 TAC §§83.1 - 83.13

The new sections are adopted under the Government Code, §403.1055 which provides the Texas Board of Health (board) with the authority to adopt rules concerning the Permanent Fund for Children and Public Health; Health and Safety Code, §121.0065 which provides the board with the authority to adopt rules for grants for essential public health services; Government Code, §403.1066 which provides the board with the authority to adopt rules concerning the Community Hospital Capital Improvement Fund; and Health and Safety Code, §12.001 which provides the board with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§83.2. Definitions.

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

(1)

Closing date - Date specified in the request for proposals as the date on which applications must be received or postmarked.

(2)

Commissioner - Commissioner of Health or his or her designee.

(3)

Department - Texas Department of Health.

(4)

Essential public health services - As defined in the Health and Safety Code, §121.002, services to:

(A)

monitor the health status of individuals in the community to identify community health problems;

(B)

diagnose and investigate community health problems and community health hazards;

(C)

inform, educate, and empower the community with respect to health issues;

(D)

mobilize community partnerships in identifying and solving community health problems;

(E)

develop policies and plans that support individual and community efforts to improve health;

(F)

enforce laws and rules that protect the public health and ensure safety in accordance with those laws and rules;

(G)

link individuals who have a need for community and personal health services to appropriate community and private providers;

(H)

ensure a competent workforce for the provision of essential public health services;

(I)

research new insights and innovative solutions to community health problems; and

(J)

evaluate the effectiveness, accessibility, and quality of personal and population-based health services in a community.

(5)

Innovation - A solution, analysis, intervention, program design, evaluation method, or administrative method that is substantially new to the area where the innovation is being introduced.

(6)

Minority populations - African-Americans, American Indians, Asians and Hispanics in Texas.

(7)

Nonprofit organization - A private, nonprofit, tax-exempt corporation, association or organization under Internal Revenue Code of 1986, §501(c)(3) (26 United States Code §501(c)(3)).

(8)

Rural area - A county that had a population in the most recent decennial United States census of 150,000 or less, or that part of a county with a population of greater than 150,000 that is not delineated as urbanized by the United States Census Bureau.

(9)

Urban area - A county or part of a county that is not a rural area.

§83.3. Philosophy.

(a)

The intent of the grants is to stimulate innovation in the delivery of essential public health services.

(b)

In making these grants, the goal of the department is to improve public health outcomes at the community level, using innovations that are replicable in other parts of Texas.

(c)

To the maximum extent possible, the grants are intended to bring about improvements in health status that are demonstrable or measurable.

(d)

Grant funds will not be used to fund direct health care services except when those services are incidental to an essential public health service being addressed.

§83.5. Sources and Allocation of Funds.

(a)

Funds for the grants shall be provided in accordance with the Government Code, §403.1055, relating to the Permanent Fund for Children and Public Health. Funds for Part III grants are also governed by the Health and Safety Code, §121.0065, relating to Grants for Essential Public Health Services.

(b)

All grants shall be awarded competitively according to the provisions of this subchapter.

(c)

Grants shall be made only to the extent that funds are appropriated and available.

(d)

The department shall have the authority and discretion to:

(1)

determine the purpose(s) of the grants pursuant to law and this subchapter;

(2)

approve or deny grant applications;

(3)

determine the number, size and duration of grants; and

(4)

modify or terminate grants.

(e)

The department shall determine the proportion of available funds to be granted under each part, provided that the funds available for each part shall be not less than 25% of the total amount of funds available. Such proportion shall be published in the request(s) for proposals.

(f)

Grants made under Part III shall be allocated in such a way so that the total amount of funds available is equally divided between services for rural and urban areas of the state.

(g)

If the funds for a part are not completely expended or allocated, the department shall have the authority to redistribute funds among the other two parts based on unfunded responses to a previous or subsequent request for proposals. The percentage in subsection (e) of this section shall not apply to the redistribution of funds.

(h)

The department shall not be liable, nor shall grant funds be used, for any costs incurred by applicants in the development, preparation, submission, or review of applications.

§83.6. Eligibility for Grants.

(a)

The following persons shall be eligible for the grants:

(1)

Part I grants. Any person or other entity, public or private, except the department;

(2)

Part II grants. Any county, municipality, public health district, other political subdivision or nonprofit organization in Texas; and

(3)

Part III grants. Any county, municipality, public health district, or other political subdivision in Texas.

(b)

An applicant may apply for grants under more than one part.

§83.7. Requirements for Grants.

(a)

The department shall specify reasonable requirements for grant applications.

(b)

Applicants for grants shall submit, as a part of their application, a preliminary plan to evaluate the effectiveness, accessibility, and quality of the essential public health services that are provided under the grant. If the applicant is awarded a grant, the grant recipient will work with the department to finalize the preliminary plan required in this section. The plan must, at a minimum:

(1)

identify the outcomes that are intended to result from the use of the grant money and establish a mechanism to measure those outcomes; and

(2)

establish performance standards for the delivery of essential public health services and a mechanism to measure compliance with those standards.

(c)

Grant recipients shall make quarterly reports to the department, in a form and at a time determined by the department.

(d)

Grant recipients under Part III must assure that they have a local health authority, as defined under the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121, prior to the grant funds being awarded. A department regional director cannot serve as the local health authority for Part III grant recipients.

§83.8. Procedures for Grant Announcements.

(a)

Before applications are requested, the department shall publish one or more notices of grant availability in the Texas Register . These notices shall also be distributed throughout the state through mail and electronic means. The notices will include details about the grants, instructions for obtaining a request for proposals, and the names of persons to contact in the department for further information.

(b)

The department shall maintain a list of persons to be notified of requests for proposals. Any person wanting to be placed on the list should contact: Commissioner of Health, Attention: TDH Innovation Grants, 1100 West 49th Street, Austin, Texas 78756.

(c)

The department shall develop and publish one or more requests for proposals, which shall contain details concerning, but not limited to, the following:

(1)

the nature and purpose(s) of the grants;

(2)

the total amount of funds available for the grants under each part;

(3)

the maximum and minimum dollar amounts that will be awarded for individual grants and for individual grantees;

(4)

the information and format required for grant applications;

(5)

information about the criteria used to judge grant applications; and

(6)

the closing date.

(d)

The department shall hold one or more optional training sessions at appropriate times, in a location(s) selected by the department, for the purpose of providing technical assistance to potential grant applicants. Travel and other expenses related to attendance at such sessions will not be paid by the department.

§83.10. Competitive Review Process.

(a)

Each application shall be reviewed by the department for completeness, relevance to the published request for proposals, adherence to department policies, general quality, technical merit, and budget appropriateness.

(b)

The department may invite an advisor or advisors to provide review and make recommendations concerning the grant process. Such advisor(s) may include any number of members from inside or outside the department, at the discretion of the commissioner. Advisor(s) from outside the department shall receive no compensation or reimbursement for expenses. No such advisor(s) shall be a current applicant for a grant under any part on which the advisor(s) would be making recommendations.

(c)

The department's review process shall be completed within 45 days after the closing date.

§83.11. Selection Criteria.

(a)

No grant shall be approved unless, in the opinion of the department:

(1)

the application addresses one or more essential public health services;

(2)

the application includes a workable plan to bring about improvements in health status that are demonstrable or measurable, or the application identifies specific positive outcomes;

(3)

the applicant provides a plan and method for evaluating the effectiveness of the activities carried out under the grant; and

(4)

with regard to Part II grants, the application addresses disparities in morbidity, mortality, or health status in minority populations.

(b)

A grant application will be given funding preference, in a manner determined by the department and announced in the request for proposal, to the extent that it:

(1)

demonstrates innovation(s) that are replicable in other parts of Texas;

(2)

documents the intent and ability of the applicant to communicate and collaborate with elements of the community that deliver essential public health services, health care providers, consumers, businesses, educational institutions, governmental agencies, law enforcement agencies, or religious institutions and how community needs have been or will be determined and addressed;

(3)

demonstrates a strong financial commitment on the part of the applicant toward the activities proposed including direct funding or significant in-kind contributions from the applicant, local entities, private donors, state agencies, federal grantors, or private foundations;

(4)

with respect to Part I and II grants, considers or inquires into one or more of the underlying causes of public health problems;

(5)

addresses or demonstrates cost-effectiveness or cost benefit;

(6)

includes a plan for the dissemination of methods, findings or conclusions;

(7)

with respect to Part III grants, demonstrates a contribution to strengthening of the essential public health services infrastructure

(8)

with respect to Part III grants, demonstrates that the applicant has or will develop a local health board or other appropriate advisory group during the grant period; or

(9)

contains such other information or criteria that the commissioner may specify and include in the request for proposals.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 21, 2000.

TRD-200000420

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 10, 2000

Proposal publication date: October 29, 1999

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


Subchapter B. COMMUNITY HOSPITAL CAPITAL IMPROVEMENT FUND

25 TAC §§83.20 - 83.30

The new sections are adopted under the Government Code, §403.1055 which provides the Texas Board of Health (board) with the authority to adopt rules concerning the Permanent Fund for Children and Public Health; Health and Safety Code, §121.0065 which provides the board with the authority to adopt rules for grants for essential public health services; Government Code, §403.1066 which provides the board with the authority to adopt rules concerning the Community Hospital Capital Improvement Fund; and Health and Safety Code, §12.001 which provides the board with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§83.21. Definitions.

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

(1)

Closing date - Date specified in the request for proposals as the date on which applications must be received or postmarked.

(2)

Commissioner - Commissioner of Health or his or her designee.

(3)

Capital improvement - The acquisition, construction, or improvement of a facility, equipment (including information system hardware and software), or real property for use in providing hospital services. The term includes designing, engineering, supervising, inspecting, surveying, and other expenses incidental to the acquisition, construction, or improvement.

(4)

Debt retirement - The reduction of interest and principal owed to another party. The retirement is typically by payment of cash or in exchange for assets, equity, or other consideration.

(5)

Department - Texas Department of Health.

(6)

Essential public health services - As defined in the Health and Safety Code, §121.002, services to:

(A)

monitor the health status of individuals in the community to identify community health problems;

(B)

diagnose and investigate community health problems and community health hazards;

(C)

inform, educate, and empower the community with respect to health issues;

(D)

mobilize community partnerships in identifying and solving community health problems;

(E)

develop policies and plans that support individual and community efforts to improve health;

(F)

enforce laws and rules that protect the public health and ensure safety in accordance with those laws and rules;

(G)

link individuals who have a need for community and personal health services to appropriate community and private providers;

(H)

ensure a competent workforce for the provision of essential public health services;

(I)

research new insights and innovative solutions to community health problems; and

(J)

evaluate the effectiveness, accessibility, and quality of personal and population-based health services in a community.

(7)

Operating expense - An expense, including an administrative expense, incurred in the daily operation of the grantee hospital.

(8)

Rural area - A county that had a population in the most recent decennial United States census of 150,000 or less, or that part of a county with a population of greater than 150,000 that is not delineated as urbanized by the United States Census Bureau.

(9)

Urban area - A county or part of a county that is not a rural area.

§83.23. Eligibility for Grants.

(a)

A public or private nonprofit community hospital licensed for 125 beds or fewer located in an urban area is eligible to apply for a grant. A hospital applying for a grant must be licensed as a general hospital under the Texas Hospital Licensing Law, Health and Safety Code, Chapter 241.

(b)

A hospital eligible to receive a rural health facility capital improvement grant, loan, or loan guarantee from the Center for Rural Health Initiatives under Health and Safety Code, Chapter 106, Subchapter G, is not eligible to receive a grant under this subchapter.

§83.26. Procedures for Grant Applications.

(a)

The department may specify any reasonable requirements for grant applications, including, but not limited to, length, format, authentication, and supporting documentation.

(b)

Applications that are substantially incomplete according to the requirements of this subchapter may be rejected without further consideration at the discretion of the department.

(c)

Applications received after the closing date will not be considered, unless the closing date is extended by the department.

(d)

Applicants will be given a minimum of 60 calendar days to file applications after a request for proposals is published. Applications must be received by the department on or before the closing date specified in the request for proposals.

§83.28. Selection Criteria.

(a)

No grant shall be approved unless, in the opinion of the department, it addresses only capital improvements and does not propose to expend funds for operating expenses or debt retirement.

(b)

A grant application will be given preference if the capital improvement(s) funded by the proposal are related to an essential public health service.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 21, 2000.

TRD-200000421

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 10, 2000

Proposal publication date: October 29, 1999

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


Chapter 125. SPECIAL CARE FACILITIES

25 TAC §125.6, §125.9

The Texas Department of Health (department) adopts an amendment to §125.6, and new §125.9, concerning special care facilities with changes to the proposed text as published in the September 24, 1999, issue of the Texas Register (24 TexReg 8080), as a result of staff comments received during the 30-day comment period.

The amendment to §125.6 will implement certain provisions of Senate Bill 1260, 76th Legislature, 1999. Senate Bill 1260 created the Advanced Directive Act, Health and Safety Code, Chapter 166, to replace the Natural Death Act. The bill also amended Chapter 248, Subchapter C, Health and Safety Code, by adding §248.0545 which requires the department to assess an administrative penalty of $500 against a special care facility that violates certain provisions of the Act. The amendment to §125.6 requires special care facilities to adopt policies and procedures for advance directives in accordance with the Advance Directive Act and includes provisions for the assessment of an administrative penalty against a facility for violation of the Act.

New §125.9 will implement Senate Bill 2085, Article 5, which amends Chapter 248, Health and Safety Code, by adding Subchapter D relating to administrative penalties for special care facilities. This subchapter sets forth standard language developed by the Sunset Advisory Commission regarding the imposition of an administrative penalty on a person who violates Chapter 248 or a rule adopted under that Chapter; the amount of the penalty; the report and notice of a violation and penalty; the penalty to be paid or hearing requested; a hearing; a decision by the commissioner; options following a decision to pay or appeal; stay enforcement of the penalty; collection of penalty; the decision by the court; the remittance of penalty and interest; the release of bond; and the administrative procedure. Section 125.9 incorporates the language of Subchapter D.

The department received no public comments during the comment period for this amendment and new section. However, the department is making the following minor changes due to staff comments to improve the readability and accuracy of the section.

Change: Concerning §125.6(a)(2)(L)(i), the entire phrase "relating to Statement Relating to Advance Directive" has been included within parenthetical marks.

Change: Concerning §125.9(a)(2), the word "subchapter" has been changed to "section" to reflect the correct subdivision of the rules that is referenced.

Change: Concerning §125.9(a)(3), the catch title "Administrative procedure" has been deleted in order to be consistent with the format of the other paragraphs within the subsection.

Change: Concerning §125.9(d)(2), following the phrase "commissioner of public health" the word "commissioner" enclosed in parenthetical marks has been added in order to clarify and provide consistency in the usage of the title throughout the section. In addition, the phrase "of public health" has been deleted from §125.9(e)(1), (e)(2)(B), (f)(1), (g), (h)(1)(B)(ii), and (h)(2) because of the clarification made to §125.9(d)(2).

Change: Concerning §125.9(e)(2), the Health and Safety Code reference has been corrected to §248.105(a).

The amendment and new section are adopted under Health and Safety Code, Chapter 166 which establishes the requirements governing the use of advance directives for certain health care facilities; Health and Safety Code, Subchapter C, §248.0545, which requires the department to assess an administrative penalty for violation by a special care facility of Health and Safety Code, Chapter 166; Health and Safety Code, Chapter 248, Subchapter D, which provides the department with the authority to assess administrative penalties against a special care facility for violation of Chapter 248 and the rules adopted thereunder; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§125.6.Standards.

(a)

Administrative management.

(1)

General requirements.

(A)

A special care facility shall comply with all applicable state and local laws.

(B)

The license will specify the maximum number of residents who can be cared for at any one time.

(C)

A special care facility license is not a license to provide day care services to children or adults; it allows the facility to provide only the services defined in the Special Care Facility Licensing Act (Act).

(D)

Each resident receiving services in a special care facility must be admitted for 24-hour residential care.

(E)

Copies of this chapter shall be available to the personnel and residents of the facility upon request.

(F)

The facility management upon request shall make available to the department representatives copies of pertinent facility documents or records which in the opinion of the representatives contain evidence of conditions that threaten the health and safety of residents. Such documents and records are residents' medical records including health care notes, pharmacy records, medication records, physicians' orders, and incident/accident reports concerning residents.

(G)

Each facility shall conspicuously and prominently post the facility license.

(H)

All accidents, whether resulting in injury, and any unusual incidents or abnormal events, including allegations of mistreatment of residents by staff, personnel, or visitors, shall be described in separate administrative records filed in the facility director's office. Certain procedures regarding accidents, unusual incidents, and abnormal events shall be observed as directed by the department.

(I)

Within 72 hours of admission, the facility must prepare a written inventory of the personal property a resident brings to the facility. The facility does not have to inventory the resident's clothing. If requested by the resident or responsible party, the inventory shall be updated. The facility should have a mechanism to protect resident clothing.

(J)

Grounds for denial, revocation, or suspension of the license in accordance with §125.7 of this title (relating to License Denial, Suspension, or Revocation and Criminal Penalties) may exist when there is substantiated evidence of the owner, director, or any employee willfully inflicting injury, physical suffering, or mental anguish on any resident in a facility; the failure of management, who is knowledgeable of a substantiated case of physical or mental abuse or neglect, to take corrective action; or the failure of management, who has cause to believe that a resident's physical or mental health or welfare has been or may be adversely affected by abuse or neglect caused by another person, to report it to the department.

(K)

A license may not be transferred or assigned.

(2)

Operating policies and procedures. The facility shall comply with its own written policies and procedures. All policies shall be reviewed and updated annually.

(A)

The facility shall have a written policy and procedure manual detailing the overall operating policies and procedures. The manual shall include information on admission and admission agreements, resident care services, charges or reimbursement for services, expectations of residents, transfers, discharges, complaint procedures, use of volunteers, protection of residents' personal property, and resident's rights.

(B)

A facility shall adopt, implement, and enforce a written policy for publicly known natural disaster preparedness for residents. The written policy shall include a plan for the reasonable mechanism for triaging residents; the notification of appropriate personnel, family members, and significant other in the event of a disaster; the identification of appropriate community resources; and the identification of possible evacuation procedures. The policy shall require how the facility will actually evacuate, transport, or triage residents should the circumstances of the disaster require such action.

(C)

A facility shall adopt, implement, and enforce a written policy to ensure compliance of the facility and its employees, volunteers, and contractors with the Health and Safety Code, §161.091, concerning the prohibition of illegal remuneration for securing or soliciting patients or patronage.

(D)

The facility shall have written personnel policies and procedures. These policies and procedures must be explained to employees when first employed and be made available to them.

(E)

In accordance with personnel policies, the facility may hire and retain employees with certain communicable diseases based on their abilities to perform on the job adequately and safely and on their willingness to follow prescribed measures to prevent the transmission of infections. Questions of employee infectious status and ability to perform duties should be resolved by consultation with a physician and/or local health authorities.

(F)

The requirements of subparagraph (E) of this paragraph shall apply to staff from outside resources and to volunteers.

(G)

The facility shall ensure that personnel records are correct and contain sufficient information to support placement in the assigned position (including a resume of training and experience). Where applicable, a current copy of the person's license or permit shall be in the file. If copying of a license is prohibited, the file shall include a notation of when the license was verified.

(H)

If the resident or the resident's responsible party entrusts the handling of cash to the facility, simple accounting records of receipts and expenditures of such cash shall be maintained. These funds must be separate from the facility's operating accounts.

(I)

The facility is encouraged to provide assistance to the residents in their securing or arranging for transportation to meet the residents' transportation needs.

(J)

In the case of an acute episode, a serious change in the resident's condition, or death, the resident's responsible party shall be notified as soon as possible.

(K)

If a facility does not employ a person qualified to provide a required or needed service, it shall have arrangements with an outside resource that has the necessary qualifications to provide the service directly to residents or to act as a consultant to the facility. Facility policies shall state the methods used to provide required or needed services. The facility may employ personnel or use appropriate volunteer services or arrange with outside resources to provide services to residents or to act as consultants to the facility. Regardless of the method or combinations of methods used, staff performing services must be appropriately qualified or supervised.

(L)

The facility shall develop, implement, and enforce policies and procedures regarding the use of advance directives in the facility. These policies and procedures shall be in accordance with the Advance Directive Act, Health and Safety Code, Chapter 166.

(i)

The department will assess an administrative penalty against a special care facility that violates Health and Safety Code, §166.004 (relating to Statement Relating to Advance Directive).

(ii)

A penalty assessed under this subparagraph shall be $500.

(iii)

The penalty will be assessed in accordance with §125.9 of this title (relating to Administrative Penalties).

(3)

Legal responsibility. There shall be an individual or individuals which assume(s) full legal responsibility for the overall conduct of the facility and are responsible for compliance with all applicable laws and rules of the department.

(4)

Facility director.

(A)

The facility director, who is to be accountable for the overall management of the facility, shall be named in writing.

(B)

The director's responsibilities shall be defined in writing.

(C)

If the facility can be successfully managed with less than the director's full-time management, the director may be less than full-time. In such instances, the director shall assign another responsible individual who can perform management tasks so that there is administrative management essentially for the usual and customary 40-hours-per-week business operations.

(D)

There shall be a competent individual authorized to be in charge of the facility when the director is absent.

(E)

The director shall be at least 18 years of age and shall be physically, mentally, and emotionally able to perform the duties of operating the facility.

(F)

The director shall be responsible for coordinating the provision of all services.

(5)

Medical care. The facility shall make arrangements for appropriate medical care as needed.

(6)

Staff development. Staff and/or volunteers shall be oriented to the basic philosophy of the facility and shall be given periodic training to update their knowledge and skills in providing care to residents. Training must include the facility's policy on confidentiality of patient's medical records. Training may be provided by the facility or by another appropriate entity.

(7)

Volunteer services.

(A)

The facility shall provide written guidelines to volunteers concerning areas such as confidentiality, infection control and sanitation, and security. It is recommended that volunteers sign a confidentiality agreement.

(B)

Volunteers may be utilized in the following areas and in any other area in which they have the necessary qualifications for the assignment such as peer counseling, support groups, advocacy, information and referral, assistance with activities of daily living, spiritual support, grief work for both resident and significant others, recreational programs, errands, transportation, and facility housekeeping and maintenance.

(C)

All volunteers will receive documented orientation to the facility which will include at a minimum location of fire alarm system; emergency procedures, including emergency phone numbers; evacuation plan; availability of counseling programs, support groups, and advocacy information; the facility's policy on confidentiality of medical records and information pertaining to patient's diagnosis, treatment, and identification; and the general mission statement of the facility.

(D)

All volunteers will receive documented training on job specifics of all assigned tasks. A detailed job description will be developed for each category of volunteer and be signed and dated by the volunteer acknowledging that he or she has read and understands the requirements and limitations of his or her assigned duties, and the facility's policy regarding the confidentiality of patient identity and information contained in medical records.

(E)

All volunteers who are performing duties that require licensure, certification, or registration must currently be licensed, certified, or registered by the appropriate board or agency and a copy of their credentials shall be kept on file in the facility. If the copying of a license or certification is prohibited, the file shall include a notation of when the license or certification was verified.

(b)

Minimum construction standards.

(1)

A facility that is classified as an institutional occupancy shall comply with the requirements found in National Fire Protection Association (NFPA), Life Safety Code (NFPA 101), Chapter 12 (concerning new construction) and Chapter 13 (concerning existing facilities), and building codes applicable to institutional use. New construction shall be subject to applicable local codes covering construction and electrical and mechanical systems for the occupancy. In the absence of, or absence of enforcement of the local codes, the department shall require conformance to the fundamentals of the following codes:

(A)

the appropriate sections of NFPA 101;

(B)

nationally recognized building codes, such as the Standard Building Code (1984) of the Southern Building Code Congress, International, Inc., or the Uniform Building Code (1988) of the International Conference of Building Officials. The nationally recognized codes used by a single facility shall be publications of the same group or organization so as to assure the intended continuity;

(C)

the Handbook of Fundamentals of the American Society of Heating, Refrigeration, and Air Conditioning Engineers; the NFPA National Electrical Code (NFPA 70);

(D)

for handicap provisions, American National Standards Institute, Standard A117.1-1980, the applicable requirements of the Texas General Services Commission, and the applicable provisions of the Americans with Disabilities Act and the regulations promulgated by that law; and

(E)

the National Standard Plumbing Code (1983) of the National Association of Plumbing Heating Cooling Contractors.

(2)

A facility may impose more stringent construction standards than the minimum construction standards in this subsection.

(3)

A facility that is classified by an occupancy other than institutional or which will house 16 or less residents shall comply with NFPA 101, Chapter 22, concerning residential board and care facilities.

(4)

All buildings or structures, new or existing, used as licensed facilities shall be in accordance with the standards in this chapter.

(5)

For existing buildings and structures which are converted to facilities, the department may modify those requirements, which, if strictly applied, would clearly be impractical in the judgment of the department. Any such modifications will be allowed only to the extent that reasonable accommodations to protect health and safety are provided and maintained.

(6)

Residents may not be admitted until all standards are met and approval for occupancy is granted by the department.

(7)

The facility shall conform to all applicable state laws and local codes and ordinances. When such laws, codes, and ordinances are more stringent than the provisions of this chapter, the more stringent requirements shall govern. Should state laws or local codes or ordinances be in conflict with the requirements of the standards in this chapter, the department shall be informed so that these conflicts may be legally resolved.

(8)

When a common wall exists between a facility and another occupancy, the common wall between the facility and the other occupancy shall be not less than a two-hour noncombustible fire-rated partition as is defined in NFPA 101, Chapter 6 (concerning features of fire protection), unless approved otherwise by the department. A licensed hospital, nursing home, custodial care home, or personal care home is not considered another occupancy for this purpose.

(9)

Planning, construction, procedures, and approvals shall be done in conformance with the following provisions.

(A)

A facility shall submit construction documents to the department if it is anticipated the facility is classified as institutional by the local building authority or will house 17 or more residents.

(B)

The construction documents shall be drawn to scale; include a plot plan; and indicate the usages of all spaces, sizes of areas and rooms, and the kind and location of fixed equipment.

(i)

The plot plan shall show all structures within 20 feet of the facility. If the local governmental unit has a building official charged with the enforcement of a local code, that authority's review of the drawings and specifications is required.

(ii)

The facility shall pay the required fee for plan review and inspection of construction at the time the proposed plans are submitted.

(C)

Before licensing, the facility shall be approved by the local fire marshal having jurisdiction for compliance with local ordinances or requirements. In the absence of a local fire marshal, the state fire marshal shall have jurisdiction. These approvals shall be provided to the department at the time of final inspection for licensure purposes.

(10)

Facility location shall be determined using the following considerations.

(A)

The facility shall be located so as to promote at all times the health, comfort, safety, and well-being of the residents.

(B)

The facility shall be serviced by a paid or volunteer fire fighting unit as approved by the department. Water supply for fire fighting purposes shall be as required or approved in writing by the fire fighting unit serving the area.

(C)

Any site conditions that can be considered a fire hazard, health hazard, or physical hazard shall be corrected by the facility as determined by the department.

(c)

Personal safety and comfort.

(1)

Fire alarm systems shall be required only in a facility which is required to have a system by local codes or under the applicable NFPA 101 occupancy category.

(2)

Approved smoke detectors shall be installed in all habitable areas, such as residential bedrooms, public areas, staff areas, and kitchens, except offices and workrooms. The primary power source for the smoke detector shall be from a commercial electrical source except that a facility which is licensed for six or less residents may use approved battery operated smoke detectors.

(3)

The fire alarm smoke detector systems shall be maintained in working condition at all times. The system will be tested on a regular basis not to exceed quarterly between tests. Documentation of quarterly tests shall be maintained.

(4)

Approved portable fire extinguishers shall be provided as required by the state or local fire authority having jurisdiction.

(5)

General fire safety shall be observed at all times.

(A)

Storage items shall be neatly arranged and placed to minimize fire hazard. Gasoline, volatile materials, paint, and similar products shall not be stored in the building housing the residents. Accumulations of extraneous material and refuse shall not be permitted. Storage of items, such as janitor supplies, shall be provided in closets or spaces separate from residential use areas.

(B)

The building shall be kept in good repair and electrical, heating, and cooling systems shall be maintained in a safe manner. Use of electrical appliances, devices, and lamps shall be such as not to overload circuits and not to require extension cords.

(C)

All fires shall be reported to the department within 72 hours; however, any fire causing injury or death to a resident shall be reported immediately to the department and appropriate law enforcement authority. A report of a fire to which the local fire authority has responded shall be followed by a copy of the local fire authority's report. All reports of fire shall be submitted to the department within 30 days on a form supplied by the department.

(D)

All personnel shall be familiar with the locations of fire-fighting equipment. There shall be a fire exit drill of personnel at least quarterly. Exit drills shall include suitable procedures to make sure that all persons in the building or all persons subject to the drill actually participate. In the conduct of the drills, emphasis shall be on the orderly evacuation under proper discipline rather than upon speed.

(6)

Waste and storage containers shall be used in the appropriate areas.

(A)

Metal wastebaskets of substantial gauge or Underwriters Laboratories, Inc. (UL) approved plastic trash containers shall be provided for bedrooms, offices, staff areas, lounges, and similar locations in a facility.

(B)

Garbage, waste, or trash containers provided for kitchens, janitor closets, laundries, general storage, and similar places must meet UL standards. Disposable plastic liners may be used in these containers for sanitation.

(C)

Plastic containers with lids are acceptable for storage of staple foods in the pantry. Dishwashing chemicals used in the kitchen may be stored in plastic containers provided they are the original containers in which the manufacturer packaged the chemicals.

(D)

All infectious waste and waste disposal procedures must comply with the department's rules and regulations concerning definition, treatment, and disposal of special waste from health-care related facilities, under Chapter 1 of this title (relating to Texas Board of Health).

(7)

The facility shall comply with the following requirements of safety and comfort.

(A)

All new carpet installed in public corridors and paths of egress shall have a maximum flame spread rate of 75 based on the "radiant panel test." Proper documentation must be provided on the letterhead of the testing company.

(B)

Only open flame heating devices which have been listed by a testing laboratory approved by the National Bureau of Standards shall be used in the appropriate locations within the facility. All fuel burning heating devices shall be vented. Working fireplaces shall have a glass enclosure that will withstand 650 degrees Fahrenheit temperature.

(C)

Smoking regulations and designated smoking areas shall be established. Ashtrays of noncombustible material and safe design shall be provided.

(D)

The facility shall develop and conspicuously post throughout the facility an emergency evacuation plan approved by the local fire marshal having jurisdiction and the department.

(E)

There shall be at least one non-coin operated telephone in the facility available to both staff and residents' use in case of emergency. Emergency telephone numbers shall be posted conspicuously at or near the telephone in a place that can be read while using the telephone.

(F)

Storage of hazardous items such as janitor supplies and equipment shall be provided in closets or spaces separate from resident-use areas. Closets or spaces shall be maintained in a safe and sanitary condition and ventilated in a manner commensurate with the use of the closet or space.

(G)

All exterior site conditions shall be designed, constructed, and maintained in the interest of resident safety. Guard rails, fences, and hand rails shall be provided where needed. Grounds, grass, shrubbery, trees, and other site features shall be maintained in a neat and attractive manner.

(H)

Tubs and showers shall have non-slip bottoms or floor surfaces, either built-in or applied to the surface.

(I)

All lavatories and bathing units shall be supplied with hot water in quantities to meet the needs of the residents. Hot water shall be controlled not to exceed 120 degrees Fahrenheit.

(J)

Cooling and heating shall be provided for resident comfort. Conditioning systems shall be capable of maintaining the comfort ranges of heating and cooling.

(K)

The facility shall be well ventilated through the use of windows, mechanical ventilation, or a combination of both.

(L)

Illumination, either natural or artificial, shall be provided to supply the needs of the residents and staff without eye strain or glare. Each resident bedroom shall have sufficient illumination for reading and general use.

(M)

A passenger elevator shall be provided in the facility for resident bedroom and use areas which are on the third floor or higher, the street floor being considered the first floor. Applicable codes shall be observed in the design and construction of elevators.

(N)

It is desirable that finish materials, colors, decorations, and furnishings contribute to physical and emotional comfort. Furniture shall be substantial and stable and of design commensurate with its function and use. Loose rugs creating a hazard shall not be permitted. Building features, furnishings, and furniture shall be provided and maintained free of hazardous conditions and in the interest of continuing resident benefit.

(O)

There shall be no occupancies or activities undesirable to the health and safety of the residents in the buildings or on the premises of the facility.

(d)

Sanitary environment.

(1)

Waste water and sewage shall be discharged into a state-approved municipal sewerage system; any exception shall be as approved by the department.

(2)

Water supply shall be as approved by the department. Quantity and pressure shall be as necessary to serve the needs of the facility.

(3)

Waste, trash, and garbage shall be disposed from the premises at regular intervals in accordance with state and local practices. Excessive accumulations are not permitted. Outside containers shall have tight fitting lids left in closed position. Containers shall be cleaned regularly.

(4)

The building and grounds shall be kept neat and free of refuse, litter, extraneous materials, and unsightly or injurious accumulations.

(5)

The facility will make every effort possible to guard against insects, rodents, rainwater, and other conditions adversely affecting a sanitary environment or the well-being of the residents.

(6)

Operable windows shall be insect screened.

(7)

An effective, safe, and continuing pest control program shall be provided. Pesticides, if used, shall be applied in accordance with all applicable laws and regulations, and shall be utilized and stored in a manner that is not hazardous to residents.

(8)

All bathrooms, toilet rooms, and other odor-producing rooms or areas for soiled and unsanitary operations shall be ventilated for odor control by means of operable windows or powered exhaust.

(9)

In kitchens and laundries, there shall be adequate equipment and procedures to avoid cross-contamination.

(10)

Floors shall be maintained in good condition and cleaned regularly; walls and ceilings shall be structurally maintained, repaired, and repainted or cleaned as needed. Storage areas, attics, and cellars shall be free of refuse and extraneous materials.

(11)

Clean linen shall be available in a quantity sufficient to meet the needs of the residents. Clean linens shall be stored in clean linen storage areas.

(e)

Accommodations.

(1)

Resident bedrooms.

(A)

Bedrooms shall be arranged and equipped for adequate delivery of services and for comfort and privacy.

(B)

Usable bedroom floor space shall be not less than 80 square feet for a one-bed room and not less than 60 square feet (40 square feet where bassinets or cribs are used) per bed for a multiple-bed room. Larger rooms are recommended for those residents needing nursing care. A bedroom shall be not less than eight feet in the smallest dimension, unless specifically approved otherwise by the department.

(C)

No more than four beds shall be in any bedroom unless approved otherwise by the department.

(D)

In the bedrooms and for each resident there shall be a bed, chair, table, dresser, and closet space or wardrobe providing security and privacy for clothing and personal belongings.

(E)

Each resident room shall have at least one operable outside window which can be readily opened from the inside without the use of tools. The height of the window sill shall not exceed 44 inches from the floor. Operable window sections may be restricted for security or safety reasons, but the required one operable section shall not be restricted to less than six inches. Each window shall be provided with a flame-retardant shade, curtain, or blind.

(F)

All resident rooms shall open upon a hallway or corridor leading to an exterior exit either by stairway or a door opening to the exterior.

(G)

All resident rooms shall be arranged for convenient and sheltered resident access to living or public areas, restrooms, and dining facilities.

(2)

Resident toilet and bathing facilities.

(A)

All bedrooms shall be served by separate private, connecting, or general toilet rooms for each sex (if the facility houses both sexes). The general toilet room or bathing room shall be accessible from a corridor or public space. A lavatory shall be readily accessible to each water closet. The facility shall provide at least one full bath on each resident sleeping floor.

(B)

One water closet and one lavatory shall be provided for each four residents or fraction thereof. Where the needs of residents require, the facility may supplement this number by using bedside commodes, although water closets are preferable. Provisions may be needed for additional toilets and handwashing facilities for staff and the general public if the department determines the residents' facilities are not conveniently accessible. One tub or one shower shall be provided for each six residents or fraction thereof.

(C)

Privacy partitions and shields shall be provided at water closets and bathing units in rooms for multi-resident use.

(D)

Soap and towel dispensers or the equivalent shall be provided at all handwashing facilities.

(3)

Recreation, living, or day room.

(A)

Recreation, living, or day room space and furniture shall be provided to allow seating of residents. Each facility shall have at least one space of not less than 144 square feet. A facility with a capacity of nine or more residents shall provide a space of 10 square feet more per resident in addition to the 144 square feet minimum.

(B)

At least one of the recreation, living, or day room areas shall have exterior windows providing a view to the outside.

(4)

Parking. The facility shall provide adequate parking accommodations for the staff, residents, and visitors.

(f)

Care and services.

(1)

Admission.

(A)

The facility shall have admission policies consonant with the mission of the facility in the care of persons. The facility may have restrictions on admission and retention of persons who use illegal drugs, who abuse alcohol, or whose actions are a threat to the health or safety of others.

(B)

Upon admission, the resident, responsible party, or facility responsible for the placement of the resident shall see that arrangements are made for the medical care of the resident by a designated attending physician or alternate physician.

(C)

The facility shall secure at the time of admission appropriate identifying information, including full name; sex; date of birth; usual occupation; social security number; family/friend name, address, and telephone number; and physician names and telephone numbers including emergency numbers.

(D)

There shall be in easily understood wording a written admission agreement between a facility and a resident. The agreement shall specify such details as services to be provided and how services will be reimbursed, and shall be based on the operational policies.

(E)

The facility shall maintain a chronological register of all residents admitted to and discharged from the facility. The register shall contain at least the name of the resident, date of birth, date of admission, date of discharge/death, and disposition (where resident went including address).

(F)

The facility shall have a written resident care document detailing the services provided. A list of the medications the resident is taking shall be included in the document. The resident, if capable, shall participate in the care document's preparation and update as needed. The facility is not required to obtain copies of records which document the care provided by other providers.

(2)

Staffing.

(A)

The facility shall be staffed with personnel or shall arrange through outside resources or volunteers for personnel in the quantity and of the disciplines, professions, or types necessary to provide the types and kinds of services stated in the policies of the facility.

(B)

For residents requiring nursing care, including the administration of injectable or intravenous medications or medications by tube into a body cavity, direct care facility personnel shall be registered professional nursing personnel, licensed vocational nursing personnel, or may be outside resource personnel or volunteers with the required qualifications.

(C)

There shall be personnel as needed to maintain cleanliness, sanitation, and safety; to prepare and serve meals; to keep a supply of clean linen; and to assure that each resident receives the kind and amount of supervision and care required to meet his or her basic needs. These personnel may be employees, be arranged for, be volunteers, or, where appropriate, be residents themselves, depending on the policies of the facility. In some facilities, these personnel may perform these functions on a periodic, as compared to an ongoing, basis.

(D)

At least one or more appropriate staff person(s) as needed shall be on duty at all times. Each shift or tour of duty shall have an appropriate staff person designated in charge. This person shall be qualified to recognize and respond to obvious sudden changes in a resident's condition and obtain necessary consultation or direct assistance by others.

(3)

Physician services.

(A)

Each resident shall have a designated attending physician who is in charge of the medical care of the resident.

(B)

The facility shall make a reasonable effort to contact the resident's physician within 72 hours after admission to obtain any information relating to the care of the resident. Any relevant information obtained from the physician will be recorded on the resident care document.

(C)

In the event of an acute illness, condition, or accident requiring medical and/or nursing care beyond the capabilities of the facility, the resident shall be transferred to a hospital or other health care facility as appropriate where needed services and facilities are available.

(4)

Nursing services.

(A)

Licensed nurses shall function consistent with the nursing practices recognized and authorized by their licensing boards in Texas.

(B)

When nursing services are provided, nursing personnel shall assure that residents requiring nursing care receive treatments, medications, and diets as prescribed; receive preventive care to discourage decubiti; are kept comfortable, clean, and well-groomed; are protected from accident and injury by adoption of indicated safety measures; and are treated with kindness and respect. Duties of nursing personnel consist of direct resident care and services.

(C)

Nursing or attendant personnel on duty shall be responsible to obtain emergency medical care when a resident's condition so requires and shall notify the applicable attending physician.

(5)

Infection control. The facility shall have written policies and procedures for the control of communicable diseases and infections in personnel, residents, volunteers, or visitors, and for a safe and sanitary environment. A facility shall adopt, implement, and enforce a written policy to ensure compliance of the facility and its employees, volunteers, and contractors with the Health and Safety Code, Chapter 85, Subchapter I, concerning the prevention of the transmission of human immunodeficiency virus and hepatitis B virus.

(6)

Resident file.

(A)

The facility shall maintain for each resident admitted a separate file with all entries kept current, dated, and signed by the recorder. The file shall include:

(i)

identification data as identified in paragraph (1)(C) of this subsection;

(ii)

medical history and physical exam reports, if available;

(iii)

any physician orders and progress notes, if available;

(iv)

any documentation of the resident's change in health condition requiring emergency procedures and/or health services provided by facility personnel;

(v)

other documents or reports related to the care of the resident as required by facility policy;

(vi)

if appropriate, documentation of nursing services provided and nursing staff observation as required by facility policy; and

(vii)

a list of medications the resident is taking.

(B)

The director shall be responsible for the organization and management of the resident file.

(C)

The facility will protect the resident file against loss, damage, destruction, and unauthorized use by:

(i)

safeguarding the confidentiality of the resident file and allowing access or release only as specifically allowed by federal or state laws;

(ii)

maintaining files in an organized manner, storing them in a protective device (manila folder, ring binder, envelope, etc.), and filing them using an organized system;

(iii)

recording entries in ink, computer, or typewritten format and keeping original reports and records; and

(iv)

storing files in a lockable area during non-use and after resident's discharge.

(D)

The following pertains to resident files.

(i)

Resident files must be retained for at least five years after services end. In the case of a minor, the resident file must be retained for at least three years after the minor reaches majority under state law.

(ii)

The facility may not destroy resident files that relate to any matter that is involved in litigation if the facility knows the litigation has not been finally resolved.

(iii)

Each resident of the facility shall have an opportunity to comply with the provisions of the Natural Death Act, Health and Safety Code, Chapter 672, if the resident desires to execute a directive under the Act.

(iv)

In the event of change of ownership, the new management shall maintain proof of the medical information required for the continuity of services of residents.

(7)

Medications.

(A)

Medications shall be provided as required for those residents on a physician-ordered medication therapy regimen.

(B)

Upon admission, and as part of the care plan, the admitting physician shall determine whether a resident can self-administer his or her medications or will require administration by qualified personnel in accordance with subparagraph (G) of this paragraph.

(C)

Each resident's health status shall be reviewed at least quarterly, or more often if indicated, to determine if any changes are necessary in the medication administration procedures.

(i)

The appropriateness for a resident to self-administer medications shall be reviewed by the facility director and attending physician.

(ii)

A resident's drug regimen review shall be incorporated into the individual's plan of care.

(D)

Residents self-administering their medications may:

(i)

keep them in their possession;

(ii)

secure their medications in a lockable cabinet in their room or within the room itself if the room is not shared with others and can be secured. Only the resident and authorized facility staff shall have access to the secured medications; or

(iii)

allow the facility to keep residents' medications in a central medication storage area under control of facility staff.

(E)

The central medication storage shall be lockable and shall be kept locked when facility staff are not actually in or at the storage area.

(F)

Residents may be permitted entrance or access to the storage area for the purpose of self-administering their medications or treatments or receiving assistance with their medication or treatment regimen. A facility staff member shall remain in or at the storage area the entire time any resident is in the storage area.

(G)

Medications that are administered to a resident shall be administered only by a registered professional nurse, licensed vocational nurse, practitioner, or individual under direct delegation orders by a physician and in conformance with all laws, rules, and recognized professional standards of practice. A home health agency who is providing services within a special care facility may use a home health medication aide in accordance with §115.62(c) of this title (relating to Home Health Medication Aides).

(i)

The person administering medications shall properly record in the appropriate record the medications administered. This record will be retained in the resident file.

(ii)

Medications may not be taken by or administered to residents unless the medication was obtained directly from or under a valid prescription or order of a physician. All medications administered to residents shall be upon written orders or verbal orders subsequently verified in writing by the treating physician.

(iii)

All injectables, intravenous solutions, or medications administered by way of a tube inserted in a cavity of the body shall be administered by a physician, registered professional nurse, or licensed vocational nurse under physician's orders.

(iv)

If administration of medications to residents is performed by a registered professional nurse or licensed vocational nurse the following shall apply.

(v)

There shall be a specific area designated for medication that is:

(I)

sufficient in size and/or space for the storage of all medications that are being administered to residents and for the preparation of medications for administration to residents;

(II)

lockable and shall be maintained locked at all times when not occupied;

(III)

accessible only to persons authorized to administer medications to residents;

(IV)

equipped with a sink having hot and cold water available at all times; and

(V)

adequately ventilated and temperature controlled.

(vi)

A medication storage cart may be used in addition to the medication room for the storage of residents' medications. When not in use, the medication storage cart must be kept locked in the locked medication room or in the designated locked storage room that shall be used only for the storage of the cart.

(H)

When a resident needs assistance with taking oral medication, only those individuals approved in writing by the director of the facility may provide that assistance.

(i)

A mechanism will be developed, implemented, and monitored by the facility director to insure that the resident is given only those medications that have been prescribed by the resident's physician at the intervals detailed on the resident's medication container.

(ii)

When assistance with taking oral medication is provided, the facility will maintain a medication record which documents the medication, date, and time taken. The name of the individual who assisted the resident taking the oral medication shall also be documented.

(iii)

The facility director or designee will monitor the medication records daily to insure accuracy.

(I)

Medication service policies and procedures shall be developed and maintained current.

(J)

Appropriate documentation shall assure that policies and procedures are reviewed at least annually.

(K)

Medication requiring refrigeration shall be stored in a separate designated area within the refrigerator in a manner which prevents contamination of the medications.

(L)

Medication under storage control of the facility shall be returned to the resident upon dismissal from the facility.

(M)

Medications of a resident shall not be used for another resident. When a resident is dismissed from or otherwise leaves the facility for a period of time greater than 48 hours, medications which had been under the control of the resident and left in the facility shall be secured under locked storage control of the facility until reclaimed by the resident and no longer than 90 days. Medications of deceased residents shall not remain in the facility for more than seven days after the resident's death. Medications of deceased residents and medications which have been left unclaimed in the facility for more than 90 days shall be handled in one of the following manners.

(i)

Medications may be returned to any licensed pharmacy for destruction in accordance with regulations of the Texas Board of Pharmacy governing the destruction of dangerous drugs or controlled substances. A record shall be maintained by the facility which itemizes the quantity and strength of each medication returned to a pharmacy for destruction. Such record shall be signed by the director of the facility and the pharmacist accepting the drugs for destruction and shall be retained in the resident's file.

(ii)

Medications may be destroyed beyond reclamation on site by the facility director. Drugs should be destroyed by incineration, if possible. Small amounts of drugs may be flushed into the sewer system unless prohibited by local ordinance. Large quantities of drugs may be destroyed by removing the drugs from the prescription containers, placing them in a strong plastic container, and adulterating the drugs with water or bleach.

(I)

A record of the destruction shall be maintained by the facility and include:

(-a-)

the name, strength, and quantity of the drug;

(-b-)

the method of destruction; and

(-c-)

the signature of the facility director who destroyed the drugs and signatures of two other individuals who witnessed the destruction.

(II)

This record shall be retained in the resident's file.

(N)

Controlled substances and drugs under storage control of the facility shall be kept separately locked in a permanently affixed compartment within the medicine room or medication storage cart.

(i)

A separate record must be maintained for each controlled substance and drug.

(ii)

The record shall include, but not be limited to, prescription number, name and strength of drug, date received by the facility, date and time each dose is provided, signature of person providing the dose, name of resident, and the original amount received with the balance verifiable by drug inventory at least daily.

(O)

All residents' medications shall be properly dispensed and/or labeled in accordance with applicable laws and regulations.

(8)

Dietary services.

(A)

A dining room, rooms, or space with appropriate furnishings shall be provided. The dining space and furnishings should allow the residents who can come to the dining room to dine at one sitting. Where alternate or second meal services are employed, those services must be equal in quantity, quality, and sanitation to the first serving.

(B)

The facility shall have a kitchen or dietary area to meet the food service needs of the residents. It shall include provisions for the storage, refrigeration, preparation, and serving of food; for dish and utensil cleaning; and for refuse storage and removal in accordance with §§229.161-229.173 of this title (relating to Food Service and Sanitation).

(C)

Meal service at intervals of at least three meals per day, seven days per week, shall be provided or arranged to be commensurate with the needs of the residents. Meals shall be palatable and meet the nutritional needs of the residents.

(D)

Procedures to prevent cross-contamination shall be observed in the storage, preparation, and distribution of food; in the cleaning of dishes, equipment, and work area; and in the storage and disposal of waste.

(E)

All dishes and utensils shall be washed in an automatic dishwasher or by the use of manual dishwashing procedures in accordance with §229.166 of this title (relating to Cleaning, Sanitization, and Storage of Equipment and Utensils).

(F)

Sanitary handwashing and drying provisions shall be provided in the kitchen area and shall include soap, water, and individual disposable towels.

(9)

Social services/pastoral care. Services to meet identified social, spiritual, and emotional needs shall be offered to the resident, the resident's family or responsible party, the resident's friend, and significant other persons. Acceptance of these services will be at the option of the resident.

(10)

Personal care services.

(A)

The facility shall provide personal care services required of residents to assist them in their day-to-day living.

(B)

All residents will need the following basic personal care services:

(i)

a safe, comfortable, and sanitary environment;

(ii)

a food service which provides wholesome and satisfying meals meeting general nutritional needs; and

(iii)

humane treatment, including responsible communication.

(C)

Some residents may need personal care services such as:

(i)

assistance with their medication regimen;

(ii)

assistance with hygiene;

(iii)

assistance with grooming, including clothing;

(iv)

assistance with ambulation; and

(v)

emotional support.

(D)

Some residents may be able to be cared for through personal care services without reliance on nursing services.

(11)

Humane treatment and resident rights.

(A)

As home-like an atmosphere as possible shall be provided. Restrictive rules shall be kept to a minimum. While some rules are necessary in group living to maintain a balance between individual wishes and group welfare, they shall not infringe upon a resident's rights of self-determination, privacy of person or thought, and personal dignity.

(B)

Through action and attitudes the facility staff shall help the residents develop and maintain self-respect, confidence, self-fulfillment, and meaningful relationships with other residents and staff.

(C)

All facility staff, including management staff and volunteers, shall, in the course of their tasks, provide emotional support.

(D)

Staff shall provide observation and precautionary measures to promote safety and protection from falling, wandering, and harm.

(E)

Abuse or punishment of residents in the facility is prohibited.

(F)

Each resident shall have unlimited freedom to move from the facility. A written release from the resident or the resident's responsible party is recommended.

(G)

No resident shall be discharged from the facility other than for reasons specified in the admission policies and without due notification.

(H)

To the extent practical, each resident shall have the right to keep and maintain his or her personal belongings in his or her possession.

(I)

Each resident shall have the right to keep and maintain his or her own finances.

(J)

Each resident shall have the right to participate in, or abstain from, religious observances.

(K)

Each resident shall have freedom to receive and send mail unopened and without undue delay.

(L)

Residents shall have the opportunity to receive visitors at reasonable hours but within reasonable limitations, as may be required by the facility in its operation policies.

(M)

Residents shall have as much freedom as possible in choice of clothing when provisions are available for laundry and dry cleaning at the individual resident's expense. Beautician and barber services shall be available for use by those desiring such outside service at the individual resident's expense.

(N)

The facility shall provide opportunities for meaningful activities and social relationships.

(O)

Use of volunteers from the community to participate and assist in meaningful resident activities is encouraged.

(P)

Rights of the elderly specified in the Human Resources Code, Title 6, Chapter 102, shall apply to residents 55 years of age or older.

(12)

Residential AIDS hospice designation.

(A)

General. A special care facility designated as a residential AIDS hospice shall meet the standards of this paragraph. These standards are in addition to the other standards described in this chapter which apply to special care facilities.

(B)

Provision of hospice services. Hospice services shall be provided as follows.

(i)

Palliative care. The facility shall provide exclusively palliative care that is reasonable and necessary to meet the needs of a resident and the management of the resident's terminal illness and related conditions.

(ii)

Support services. Support services shall be available to both the resident and the family.

(I)

There shall be an organized program for the provision of support services under the supervision of a qualified individual who may be a person with a master of social work, an accredited member of the clergy, or a person with appropriate training and experience.

(II)

Support services shall include social, spiritual, and emotional care provided to a resident and the family.

(iii)

Counseling services. Counseling services shall be available to the resident and the family. If provided, counseling services shall be identified as a need in the resident's plan of care described in clause (v) of this subparagraph.

(iv)

Bereavement services. Bereavement services shall be available to the family. The provision of bereavement services shall be:

(I)

provided in an organized program under the supervision of a qualified person who may be a person with a master of social work, an accredited member of the clergy, or a person with appropriate training and experience;

(II)

available to families for up to one year following the death of the resident; and

(III)

identified as a need for the family in the resident's plan of care described in clause (v) of this subparagraph.

(v)

Plan of care. The interdisciplinary team shall develop a plan of care for each resident receiving hospice services.

(I)

A registered nurse shall participate in developing the initial plan of care for each resident receiving hospice services.

(II)

The facility shall use an interdisciplinary team in implementing and reviewing the plan of care.

(-a-)

The interdisciplinary team shall consist of a physician, a registered nurse, and other appropriate members who are involved with the resident's care.

(-b-)

A member of the interdisciplinary team may be a volunteer, an employee of the facility, an individual under contract with facility, or an employee or representative of a home and community support services agency employed by the resident to provide services.

(-c-)

The interdisciplinary team shall review and revise the resident's plan of care periodically as necessary, but not less than once a month, in providing hospice services to the resident.

(III)

The plan of care shall identify the need for counseling and bereavement services, as appropriate.

(vi)

Clinical and medical review. A physician shall conduct a clinical and medical review of the care and services provided to a resident receiving hospice services. The physician conducting the review shall serve as a member of the interdisciplinary team described in clause (v)(II) of this subparagraph. The physician may be an employee, a volunteer, or a contracted consultant to the facility.

(C)

A special care facility's designation as a residential AIDS hospice must be approved by the department prior to the implementation of hospice services.

(i)

A special care facility may request designation as a residential AIDS hospice at the submission of the initial application by completing the applicable section on the initial application; or by submitting a written request to the department for the designation at any time during the renewal period.

(ii)

A written request for designation as a residential AIDS hospice submitted during a renewal period shall include the evidence described in §125.2(a)(15) of this title (relating to Application and Issuance of License for First-Time Applicants).

(iii)

The department shall send written notice approving or disapproving the designation to the facility. If disapproved, the written notice shall state the reasons for the disapproval and the facility may submit additional information to the department supporting the request for the designation.

(iv)

The facility may withdraw the residential AIDS hospice designation by submitting to the department a written request to withdraw. The written request to withdraw shall include the effective date of withdrawal. A facility which withdraws the designation must resubmit the request as described in clause (ii) of this subparagraph in order to re-establish hospice services.

(13)

Laboratory services. A facility which provides laboratory services must meet the requirements of federal Public Law 100-578, Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988 applies to all facilities with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(g)

Waivers, modifications, and variations to provisions of this section.

(1)

On the request of the facility, the department may grant a waiver or modification for certain provisions of the physical plant and environment which, in the opinion of the department, would be impractical for the facility to meet. In granting the waiver or approving the modification, the department shall determine that there will be no adverse effect on resident health or safety, and the requirement, if not waived or modified, would impose an unreasonable hardship on the facility in providing adequate care for the residents. The department may require offsetting or equivalent provisions in granting such a waiver or approving such a modification.

(2)

On the request of the facility, the department may grant a waiver or approve a variation for certain provisions of facility operation which, in the opinion of the department, would be impractical or inappropriate for the facility to meet. In granting the waiver or approving the variation, the department shall determine that there will be no adverse effect on resident health or safety, and the requirement, if not waived or varied, would impose an unreasonable hardship on the facility in providing adequate care to residents. The department may require offsetting or equivalent provisions in granting such a waiver or approving such a variation.

§125.9.Administrative Penalties.

(a)

Imposition of penalty.

(1)

The Texas Department of Health (department) may impose an administrative penalty on a person licensed under this chapter who violates the Act, this chapter, or order adopted under this chapter.

(2)

A penalty collected under this section shall be deposited in the state treasury in the general revenue fund.

(3)

A proceeding to impose the penalty is considered to be a contested case under Government Code, Chapter 2001.

(b)

Amount of penalty.

(1)

The amount of the penalty may not exceed $1,000 for each violation. Each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. The total amount of the penalty assessed for a violation continuing or occurring on separate days under this paragraph may not exceed $5,000.

(2)

In determining the amount of an administrative penalty assessed under this section, the department shall consider:

(A)

the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;

(B)

the threat to health or safety caused by the violation;

(C)

the history of previous violations;

(D)

the amount necessary to deter a future violation;

(E)

whether the violator demonstrated good faith, including when applicable whether the violator made good faith efforts to correct the violation; and

(F)

any other matter that justice may require.

(c)

Report and notice of violation and penalty.

(1)

If the department initially determines that a violation occurred, the department will give written notice of the report by certified mail to the person alleged to have committed the violation not later than 90 days following the survey exit date.

(2)

The notice must include:

(A)

a brief summary of the alleged violation;

(B)

a statement of the amount of the recommended penalty based on the factors listed in subsection (b)(2) of this section; and

(C)

a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both.

(d)

Penalty to be paid or hearing requested.

(1)

Within 20 days after the date the person receives the notice sent under subsection (c) of this section, the person in writing may:

(A)

accept the determination and recommended penalty of the department; or

(B)

make a request for a hearing on the occurrence of the violation, the amount of the penalty, or both.

(2)

If the person accepts the determination and recommended penalty or if the person fails to respond to the notice, the commissioner of public health (commissioner) or the commissioner's designee by order shall approve the determination and impose the recommended penalty.

(e)

Hearing.

(1)

If the person requests a hearing, the commissioner or the commissioner's designee shall refer the matter to the State Office of Administrative Hearings (SOAH).

(2)

As mandated by Health and Safety Code, §248.105(a), the SOAH shall promptly set a hearing date and give written notice of the time and place of the hearing to the person.

(A)

An administrative law judge of the SOAH shall conduct the hearing.

(B)

The administrative law judge shall make findings of fact and conclusions of law and promptly issue to the commissioner a proposal for a decision about the occurrence of the violation and the amount of a proposed penalty.

(f)

Decision by commissioner.

(1)

Based on the findings of fact, conclusions of law, and proposal for a decision made by the administrative law judge under subsection (e)(2) of this section, the commissioner or the commissioner's designee by order may find that a violation has occurred and may impose a penalty or may find that no violation has occurred.

(2)

The commissioner or the commissioner's designee shall give notice of the commissioner's order under paragraph (1) of this subsection to the person alleged to have committed the violation in accordance with Government Code, Chapter 2001. The notice must include:

(A)

a statement of the right of the person to judicial review of the order;

(B)

separate statements of the findings of fact and conclusions of law; and

(C)

the amount of any penalty assessed.

(g)

Options following decision: pay or appeal. Within 30 days after the date the order of the commissioner under subsection (f) of this section that imposes an administrative penalty becomes final, the person shall:

(1)

pay the penalty; or

(2)

appeal the penalty by filing a petition for judicial review of the commissioner's order contesting the occurrence of the violation, the amount of the penalty, or both.

(h)

Stay of enforcement of penalty.

(1)

Within the 30-day period prescribed by subsection (g) of this section, a person who files a petition for judicial review in accordance with subsection (g)(2) of this section may:

(A)

stay enforcement of the penalty by:

(i)

paying the penalty to the court for placement in an escrow account; or

(ii)

giving to the court a supersedeas bond that is approved by the court for the amount of the penalty and that is effective until all judicial review of the commissioner's order is final; or

(B)

request the court to stay enforcement of the penalty by:

(i)

filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(ii)

sending a copy of the affidavit to the commissioner by certified mail.

(2)

If the commissioner receives a copy of an affidavit under paragraph (1)(B) of this subsection, the commissioner may file with the court, within five days after the date the copy is received, a contest to the affidavit. In accordance with Health and Safety Code, §248.108(b), the court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(i)

Collection of penalty.

(1)

If the person does not pay the penalty and the enforcement of the penalty is not stayed, the department may refer the matter to the attorney general for collection of the penalty.

(2)

As provided by Health and Safety Code, §248.109(b), the attorney general may sue to collect the penalty.

(j)

Decision by court. A decision by the court is governed by Health and Safety Code, §248.110, and provides the following.

(1)

If the court sustains the finding that a violation occurred, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty.

(2)

If the court does not sustain the finding that a violation occurred, the court shall order that no penalty is owed.

(k)

Remittance of penalty and interest and release of supersedeas bond. The remittance of penalty and interest is governed by Health and Safety Code, §248.111 and provides the following.

(1)

If the person paid the penalty and if the amount of the penalty is reduced or the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, that the appropriate amount plus accrued interest be remitted to the person within 30 days after the date that the judgment of the court becomes final.

(2)

The interest accrues at the rate charged on loans to depository institutions by the New York Federal Reserve Bank.

(3)

The interest shall be paid for the period beginning on the date the penalty is paid and ending on the date the penalty is remitted.

(l)

Release of bond. The release of supersedeas bond is governed by Health and Safety Code, §248.112 and provides the following.

(1)

If the person gave a supersedeas bond and the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, the release of the bond.

(2)

If the person gave a supersedeas bond and the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the reduced amount.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 20, 2000.

TRD-200000390

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 9, 2000

Proposal publication date: September 24, 1999

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


Chapter 229. FOOD AND DRUG

The Texas Department of Health (department) adopts the repeal of §§229.87 - 229.88 and new §§229.87 - 229.91 concerning production, processing, and distribution of bottled and vended drinking water. New §229.89 and §229.90 are adopted with changes to the proposed text as published in the September 24, 1999, issue of the Texas Register (24 TexReg 8092). New §§229.87, 229.88 and 229.91and repealed §229.87 and §229.88 are adopted without changes, and therefore the sections will not be republished.

Specifically, the criteria and definitions in these sections shall apply to the production, processing, and distribution of safe and sanitary bottled and vended drinking water. The proposed new sections ensure that persons involved with the production, processing, and distribution of bottled and vended drinking water pass an examination and obtain a certificate of competency prior to engaging in the bottling or vending of drinking water.

Health and Safety Code, Chapter 441, Regulation of Bottled and Vended Drinking Water (the Act), enables the department to adopt rules that are necessary to implement certification of bottled and vended water operators that promote public health and safety. The Act specifically requires the department to assess a $25 application fee, test the applicant, and issue the certificate if the applicant passes the exam. The Act also permits the department to adopt rules relating to certificate renewals and disciplinary actions.

Pursuant to the Government Code, §2001.039, each state agency is required to review and consider for readoption each rule adopted by that agency. Sections 229.81 - 229.86 have been reviewed and the department has determined that reasons for adopting the sections continue to exist. Sections 229.81 - 229.86 are being readopted without any changes.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §229.89, one commenter urged the department to require attendance at an approved course in good manufacturing practices for bottled and vended water prior to taking the exam for a new certificate. The commenter stated that course attendance would provide the applicant with a broad range of essential knowledge that cannot be covered just by the test questions. The commenter suggested that an "approved course" include current information relevant to bottled water from industry and government sources.

Response: The department disagrees. Although the department strongly supports course attendance as one way to prepare applicants to pass the certification examination and obtain current information, the Act does not specify that applicants must attend a course nor does it authorize or require the department to approve courses. In addition, the department must recognize that knowledge required to pass the exam may be acquired through alternative education methods including self-study and job experience. Mandatory course attendance could pose a cost burden on bottled and vended water operators that was not deliberated during passage of the legislation. Therefore, the department concludes that the rules may not be amended to require mandatory course attendance prior to taking the certification exam. No change was made as a result of this comment.

Comment: Concerning §229.90(3), two comments urged the department to require applicants to attend a course prior to renewal of a certificate of competency. One comment suggested that attendance at three presentations on industry specific manufacturing or quality assurance topics by approved organizations be recognized as equivalent to course attendance. The objective is to obtain current information through continuing education.

Response: The department disagrees. The department recognizes that continuing education is needed to maintain current knowledge of changes in the bottled and vended water industry. However, the Act does not require course attendance for certificate renewal, nor does it authorize or require the department to approve courses, presentations, or industry organizations. In addition, mandatory attendance at courses or presentations would pose a cost burden on bottled and vended water operators that was not deliberated during passage of the legislation. The department intends to assess whether the certificate of competency should be renewed based in part on the compliance status and history of the firm represented by the bottled or vended operator. Therefore, for the reasons discussed above, the department concludes that the rules may not be amended to require mandatory attendance at courses or presentations prior to renewal of the certificate of competency. No change was made as a result of these comments.

Comment: Concerning §229.90(3), one commenter suggested that the department make a certificate valid for three years.

Response: The department agrees that a three year validation period is reasonable and will reduce the fiscal impact for the operators and State government. Therefore, language in §229.90(3) has been amended.

Comment: One commenter recommended §229.89(a) be changed to "After payment of the required fee, an applicant shall (have passed - deleted) pass a written examination prescribed by the department."

Response: The department disagrees with amending the language because it would require operators previously certified by the department to retake an exam, which was not the legislative intent. No change was made as a result of this comment.

Comment: Concerning §229.90(3), one commenter recommended changing the new certificate and the certificate renewal fee to $75 to compensate for extending the period of validation from one to three years.

Response: The department disagrees with this comment because the $25 fee to obtain or renew a certificate specified in Chapter 441 is adequate to recoup the department's costs. No change was made as a result of this comment.

The department is making the following changes to clarify the intent and improve the accuracy of the sections.

Change: Concerning adopted §229.89, the statement "The requirement for testing will be waived prior to June 1, 2000, for persons who have previously held a class "C" or higher Bottled and Vended Water Operators Certificate. Proof of previous certification will be required," has been added. This will allow persons who already have obtained knowledge of the bottled and vended water regulations to waive the requirement to take another test on the same basic information.

Change: Concerning §229.90(2), "Annual renewal" was changed to "Renewal" for clarity.

Change: Concerning adopted §229.90(3), the wording "Certificates can be renewed by submitting an application with the $25 renewal fee. Certificates are valid for up to three years. Certificates will expire on December 31st, within three years of the date of issue. Fees will not be prorated. If the department has not received an application for renewal by January 31st, following the expiration date the certificate holder shall submit a new application and retake the examination," has been added or changed for clarity. The sentence "All certificates will expire on December 31st of each year" has been deleted.

Subchapter F. PRODUCTION, PROCESSING, AND DISTRIBUTION OF BOTTLED AND VENDED DRINKING WATER

25 TAC §§229.87 - 229.91

The new sections are adopted under the Health and Safety Code, §146.010(a) and §146.015(a), which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of this Chapter; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§229.89. Examination.

(a)

After payment of the required fee, an applicant shall have passed a written examination prescribed by the department. To pass the examination for a certificate of competency, the applicant must make a score of 70% or more. In the case of failure, the applicant may reapply, pay another $25 application fee, and repeat the examination after a period of 30 days. The requirement for testing will be waived prior to June 1, 2000, for persons who have previously held a Class "C" or higher Bottled and Vended Water Operator's Certificate. Proof of previous certification will be required.

(b)

An instructor may administer the department's examination provided the instructor complies with the department's security agreement.

§229.90. Fees.

The fees for certification shall be established as follows.

(1)

Certification fee - $25.

(2)

Renewal fee - $25.

(3)

A certificate can be obtained by submitting an application with the $25 certification fee and receiving a passing score on the examination. Certificates can be renewed by submitting an application with the $25 renewal fee. Certificates are valid for up to three years. Certificates will expire on December 31st, within three years of the date of issue. Fees will not be prorated. If the department has not received an application for renewal by January 31st, following the expiration date, the certificate holder shall submit a new application and retake the examination.

(4)

Fees shall be paid by personal check, cashier's check, or money order. Cash cannot be accepted for payment of fees.

(5)

An applicant or holder of a certificate shall pay the required fee before taking the examination or receiving a certificate of competency.

(6)

All fees shall be made payable to the Texas Department of Health and are not refundable.

(7)

All applicants shall be in compliance with §1.301 of this title (relating to Suspension of License for Failure to Pay Child Support).

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2000.

TRD-200000323

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2000

Proposal publication date: September 24, 1999

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


25 TAC §229.87, §229.88

The repeals are adopted under the Health and Safety Code, §146.010(a) and §146.015(a), which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of this Chapter; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2000.

TRD-200000322

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2000

Proposal publication date: September 24, 1999

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