The Texas Department of Human Services (DHS) proposes amendments to §§97.1-97.3 (Subchapter A, General Provisions), §97.11, §§97.13-97.16 (Subchapter B, Application and Issuance of a License); the repeal of §§97.21-97.28 (Subchapter C, Service Standards), §§97.51-97.54 (Subchapter D, Enforcement), §§97.61-97.62 (Subchapter E, Home Health Aides and Medication Aides), and §§97.71-97.72 (Subchapter F, Advisory Committees); and proposes new §97.201 (new Subchapter C, Minimum Standards for All Home and Community Support Services Agencies (HCSSAs), General Provisions), §§97.211-97.222 (new Subchapter C, Minimum Standards for All HCSSAs, Conditions of a License), §§97.241-97.257 (new Subchapter C, Minimum Standards for All HCSSAs, Agency Administration), §§97.281-97.303 (new Subchapter C, Minimum Standards for All HCSSAs, Provision and Coordination of Treatment and Services), and §§97.321-97.322 (new Subchapter C, Minimum Standards for All HCSSAs, Branch Offices and Alternate Delivery Sites), §§97.401-97.407 (new Subchapter D, Additional Standards Specific to License Category and Specific to Special Services), §§97.501-97.502 (new Subchapter E, Surveys), §§97.601-97.604 (new Subchapter F, Enforcement), and §97.701 (new Subchapter G, Home Health Aides), in its Licensing Standards for Home and Community Support Services Agencies chapter. The phrase "Licensing Standards for" is being added to the chapter title to identify the rules as licensing rules.

DHS has been reviewing Chapter 97 since the HCSSA program was transferred to this agency in September 1999 in order to reorganize the rule base, clarify ambiguous wording, eliminate duplication, strengthen the licensure standards where needed and to reformat the end product to make it more consumer friendly. This rule package is the second part of a three-part review of Chapter 97. The second part of the review concentrated on Subchapter C, Service Standards.

To accommodate the reorganization of Subchapter C and to allow for the future expansion of Subchapter B, all of existing Subchapters C - F are being repealed and proposed as new rules under Chapter 97, Subchapters C - G, with the exception of §97.62, §97.71, and 97.72. Section 97.62, concerning home health medication aides, is being repealed and has been proposed as 40 TAC §95.128 in the March 30, 2001, issue of the Texas Register. Section 97.71, concerning the HCSSA Advisory Council, and §97.72, concerning the DHS/Board of Nurse Examiners Memorandum of Understanding Advisory Committee, are being repealed and have been proposed as new 40 TAC §79.403(f) and (g) in the April 13, 2001, issue of the Texas Register.

New Subchapter C contains the minimum standards that are applicable to all HCSSAs.

New Subchapter D contains additional standards that are specific to license category and specific to special services that an agency may provide. The license categories covered under Subchapter D include licensed home health services, licensed and certified home health services, hospice services, personal assistance services, home dialysis services, psychoactive services, and home intravenous therapy.

New Subchapters E and G contain the procedures for survey and complaint investigation and enforcement, and requirements for home health aides. Existing §97.54, concerning criminal history checks for unlicensed personnel was inappropriately located in the rule base under enforcement and is being repealed and proposed as new §97.247 under agency responsibilities in new Subchapter C. These subchapters and the criminal history check procedures have not yet been subject to a review to reorganize the rule base, clarify ambiguous wording, eliminate duplication and to reformat the end product to make it more consumer friendly; however, certain revisions were made to address concerns in the rules in need of immediate attention. These revisions are described in the summary of rule changes further on in this preamble.

New Subchapters E and G, as well as rule language covering the HCSSA Advisory Council, the DHS/Board of Nurse Examiners MOU Advisory Committee, and criminal history check procedures will undergo a complete review by DHS during the third and final part of the a three part schedule for review of Chapter 97 rules.

A summary of the major rule changes included in this proposal is as follows.

New definitions are added and existing definitions are amended for clarification, to remove regulatory language, and to comply with statutory changes.

Under conditions of a license, language is added to require an agency to post notice of any changes in the agency license so the public is made aware of any changes in an agency's license. Language that required DHS's approval prior to an agency transfer is being deleted, because it was determined to exceed statutory authority. An agency must still provide notification to DHS 30 calendar days before the intended relocation. Notification requirements for certain agency changes are being amended to provide notification to DHS before the changes rather than after the changes occur. Language is also proposed to require criminal history checks for a new administrator and a new chief financial officer. Additionally, language is proposed to require an agency to provide written notice 30 days prior to the expansion of its service area, instead of 30 days after the effective date of the expansion. This includes parent agencies, branch offices, and administrative support sites. This will allow DHS time to review compliance history. An exemption is proposed for emergencies that will be determined by DHS.

New requirements are proposed for policies governing client conduct and responsibility and client rights applicable to all agencies, peer review to ensure that all professional disciplines comply with their respective professional practice act, and drug testing of an agency's employees if testing is performed by an agency. A new policy requirement is added to ensure that clients are educated in how to access care from another health care provider after regular business hours. Another new policy requirement is proposed that requires an agency to ensure that all employees are fully informed and understand all of the agency's policies.

Statutory language specific to advance directives policy requirements is added. Current rules just reference the statutory language. Minimum standards for infection control are established. Existing language just requires a policy for infection control.

Minimum standards are established for a Quality Assurance (QA) Program, QA committee membership, and frequency of QA committee meetings. Existing rules were determined to be too vague.

New language is proposed and existing language is amended to require that the steps taken to coordinate services be documented in the client record, to clarify existing client record requirements, and to establish a time limit of 14 days for incorporating clinical and progress notes into the clinical record. Current rules do not specify a time limit.

New language is added to strengthen the use of volunteers.

Two new agency disclosure requirements are proposed for reporting of abuse, neglect, or exploitation of a client, and for an agreement to and acknowledgement of services by home health medication aides.

New language is proposed to require that lists of clients be maintained for each category of service licensed and specific information be included on the list. This will enable DHS surveyors to survey an agency based on category of service provided.

Language is proposed to allow physician orders to be received via facsimile and to require an agency to adopt a policy for protocols to follow when accepting physician orders via facsimile.

Management and ownership responsibilities are added in accordance with statutory requirements. The rules will make the licensee more accountable for the operations of the agency. New language requires that an agency have a written organization structure in a chart or narrative format. The language clarifies DHS's expectations for the written organization structure. New language also requires the licensee to appoint the administrator as well as an alternate to act in the administrator's absence. Existing rules assign responsibility for the appointment of an alternate to the administrator.

The following additional job responsibilities are proposed for the administrator: to ensure adequate staff education and evaluations, and to supervise and evaluate client satisfaction survey reports. Health and Safety Code, §142.0011, added in 1999, requires the rules to address client satisfaction. Additional qualifications for the administrator, including the alternate or other designee, are added. An administrator who qualifies under the training and experience qualification must also have a high school diploma or a GED. This is also added to the qualifications for the administrator of an agency licensed to deliver personal assistance services only. Continuing education (CE) requirements are added as a condition of employment for the administrator. The administrator must have documented completion of a minimum of six clock hours per year at a health service administration seminar.

New language is added to allow the supervising nurse to be available in person or via telecommunication, so that the supervising nurse could be located at all times. An amendment to the qualification that requires the supervising nurse to "be a registered nurse (RN)" clarifies that the registered nurse must to be "licensed in the state of Texas or in accordance with the Board of Nurse Examiners rules for Nurse Licensure Compact (NLC)."

An amendment to the qualification that establishes the experience requirements for the supervising nurse requires at least two years of current experience as a registered nurse in a health care setting that provides care for children, adults, or geriatric clients. For experience to be considered current, it must have been obtained within three years prior to assuming the role of supervising nurse. One year of experience working as a consultant or in some other capacity that entailed administering home health care standards may be substituted for one year of the required nursing experience. DHS is concerned that many agencies were filling these positions with individuals without any real experience in the area of a home or health care setting that provides for children, adults, or geriatric clients. There is real concern that individuals may be reentering the nursing field after a period of time and are not current on the latest information or best practices. This area is changing so rapidly that it is important that professionals, who are acting in the role of a supervising nurse and are directing other staff, be well-informed and knowledgeable about the most recent medical and social advances. DHS believes that increasing the experience requirements for the supervising nurse will help ensure higher quality of care and service. DHS also believes that many of the current quality of care and service concerns that are occurring at agencies will decrease by requiring a more experienced supervising nurse.

Under standards specific to licensed home health agencies, the following changes are proposed. Language relating to the qualifications for the social worker when performing medical social services is added. The qualifications are inappropriately located in the definitions section in current rules. A requirement is added that unlicensed personnel utilized by an agency to provide home health services be required to demonstrate competency in the task assigned when competency cannot be determined through education, license or certification, or experience.

Under standards specific to agencies licensed to provide hospice services, the following changes are proposed. The term "drug profile" is changed to "medication list" and the definition of "medication list" is modified to reflect the change in the definition section. An agency must keep a medication list, and a pharmacy keeps a drug profile. Language is added to require the hospice physician or registered nurse to contact the client within 24 hours prior to the start of care to determine the immediate care and support needs of the client. Language that prohibited a hospice from discontinuing care provided to or discharging a client because of the client's inability to pay for that care is being removed because the rule was determined to exceed DHS's authority to impose as a licensing standard. In addition, the administrative penalty for violation of that rule is being removed as well. Some of the language relating to volunteers and client rights is moved to Subchapter C to apply to all licensed categories of agencies.

Under standards specific to agencies licensed to provide personal assistance services (PAS), the following changes are proposed. Requirements are added for including the "planned date of service initiation" in the individualized service plan. Gastrostomy tube (g-tube) feedings or medication administration are no longer limited to short-term respite care. The proposal also clarifies language relating to the qualified trainer of a training and competency program for the performance of g-tube feedings.

Under standards specific to agencies licensed to provide home dialysis services, the following changes are proposed. Client rights specific to home dialysis are moved to Subchapter C and made applicable to all agencies. Requirements are added for having emergency drugs available as specified by the medical director. Standards for performing home dialysis are updated to reflect current standards.

Under DHS's survey procedures, language is added to state that immediate enforcement action will be taken for failure to grant access to all books, records, or other documents maintained by or on behalf of the agency to the extent necessary to ensure compliance with the statute, rules, an order of the commissioner, a court order granting injunctive relief, or other enforcement action. Additionally, the proposal clarifies that, if Medicare certification for a licensed and certified agency is denied by the Health Care Financing Administration (HCFA) or the agency withdraws from the Medicare program, the agency may only operate under the category remaining on the current license.

Under DHS's procedures for license denial, suspension, or revocation, if DHS takes enforcement action against an agency, its owner(s), or its affiliate(s), the agency may not apply for an agency license "or make any requests to change categories of license for one year" following the effective date of the enforcement action. The language "or make any requests to change categories of a license for one year" is new language. DHS has had agencies that are licensed with the categories of "licensed and certified" and "personal assistant services," when their licensed and certified (Medicare) category is terminated for poor quality of care and they want to add the category of licensed home health services. A year's wait would allow the home health agency to regroup and educate the staff to provide skilled services.

The schedules of administrative penalties are amended to reflect the reorganization of the new rules. In instances where a rule previously applied only to one category of license but now applies to all categories of licenses and where there was a penalty already established for violation of that rule, the penalty will be applied to all categories of licenses for failure to comply. The schedule of penalties are more streamlined to reflect the elimination of duplication and the reorganization of the rule base.

Additional minor changes are made throughout the rules for the purpose of updating and clarifying language.

Eric M. Bost, commissioner, has determined that for the first five-year period the sections are in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the sections.

Mr. Bost also has determined that for each year of the first five years the section are in effect the public benefit anticipated as a result of adoption of the proposed rule will be more consumer-friendly rules that have been streamlined by clarifying ambiguous wording, eliminating duplication, strengthening the licensure process, and reformatting. As a result of the new requirements for six clock hours of continuing education, there may be an increase in economic cost to persons who are administrators of home and community support services agencies and are required to comply with the proposed sections. It is difficult to determine if there will be an increase in cost, because some continuing education is provided at no cost. Also, if an administrator presently receives at least six clock hours of the required continuing education per year, there will be no additional cost to the individual. Some HCSSAs may opt to pay for the continuing education if there is a cost. The estimated cost to individuals, small businesses, microbusinesses, or large businesses will depend on who pays and is estimated to be under $500 annually.

Questions about the content of this proposal may be directed to Linda Kotek at (512) 438-3158 in DHS's Long Term Care Section. Written comments on the proposal may be submitted to Supervisor, Rules and Handbooks Unit-049, Texas Department of Human Services E-205, P.O. Box 149030, Austin, Texas 78714-9030, within 30 days of publication in the Texas Register.

Under §2007.003(b) of the Texas Government Code, the department has determined that Chapter 2007 of the Government Code does not apply to these rules. Accordingly, the department is not required to complete a takings impact assessment regarding these rules.

The amendments are proposed under the Health and Safety Code, Chapter 142, which provides the department with the authority to adopt rules for the licensing and regulation of home and community support services agencies.

The amendments implement the Health and Safety Code, Chapter 142.001-142.030.