The Texas Department of Human Services (DHS) adopts 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 and §97.62 (Subchapter E, Home Health Aides and Medication Aides), and §97.71 and §97.72 (Subchapter F, Advisory Committees); and adopts 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 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 and §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 and §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. Sections 97.1, 97.2, 97.11, 97.15, 97.201, 97.214, 97.215, 97.217, 97.219, 97.220, 97.241, 97.243 - 97.245, 97.247 - 97.249, 97.256, 97.257, 97.281-97.285, 97.287, 97.289 - 97.293, 97.295, 97.296, 97.300, 97.301, 97.303, 97.321, 97.322, 97.401 - 97.407, 97.501, 97.502, 97.601, 97.602, and 97.701 are adopted with changes to the proposed text published in the April 27, 2001, issue of the Texas Register (26 TexReg 3159). Sections 97.3, 97.13, 97.14, 97.16, 97.211 - 97.213, 97.216, 97.218, 97.221, 97.222, 97.242, 97.246, 97.250 - 97.255, 97.286, 97.288, 97.294, 97.297 - 97.299, 97.302, 97.603, and 97.604 are adopted without changes and will not be republished. The phrase "Licensing Standards for" is added to the chapter title to identify the rules as licensing rules.

The department's justification for proposing and adopting the amendments, repeals, and new sections is set forth below, except for changes made in response to comments received, which are indicated in the individual responses to comments contained further on in this preamble. Justification for the amendments, repeals, and new sections is 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. DHS has been reviewing Chapter 97 since the HCSSA program was transferred to this agency in September 1999. 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 Subchapters C - F, all of existing Subchapters C - F are repealed and adopted 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, was repealed and readopted under 40 TAC §95.128 in the June 1, 2001, issue of the Texas Register (26 TexReg 3944). Section 97.71, concerning the HCSSA Advisory Council, and §97.72, concerning the DHS/Board of Nurse Examiners Memorandum of Understanding Advisory Committee, was repealed and readopted under 40 TAC §79.403(f) and (g) in the June 22, 2001, issue of the Texas Register (26 TexReg 4734).

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

New Subchapter D contains additional standards specific to special services 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 - 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 has been repealed and adopted 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 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.

New Subchapters E - 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.

References to the Health Care Financing Administration (HCFA) were changed to the Centers for Medicare & Medicaid Services (CMS) throughout the rules. The U.S. Department of Health and Human Services changed the name of the agency that runs the Medicare and joint federal-state Medicaid programs in June 2001.

A summary of the major proposed rule changes follows.

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

Under conditions of a license, language was proposed 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 was proposed to be deleted, because it was determined to exceed statutory authority. An agency would still provide notification to DHS 30 calendar days before the intended relocation. Notification requirements for certain agency changes were proposed to provide notification to DHS before the changes rather than after the changes occur. Language was also proposed to require criminal history checks for a new administrator and a new chief financial officer. Additionally, language was 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 amend the license to reflect the new licensed service areas. An exemption was proposed for emergencies.

New requirements were 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 was proposed to ensure that clients are educated in how to access care from another health care provider after regular business hours. Another new policy requirement was 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 was proposed. Rules had only reference the statutory language. Minimum standards for infection control were proposed. Language had only required a policy for infection control.

Minimum standards were proposed 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 was proposed and existing language was 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. Rules had not specified a time limit.

New language was proposed to strengthen the use of volunteers.

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

New language was 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 was 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 were proposed in accordance with statutory requirements. The rules make the licensee more accountable for the operations of the agency. New language requires an agency to have a written organizational structure in a chart or narrative format. The language clarifies DHS's expectations for the written organizational structure. New language was proposed to require the licensee to appoint the administrator as well as an alternate to act in the administrator's absence. Rules had assigned responsibility for the appointment of an alternate to the administrator.

The following additional job responsibilities were 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 rules to address client satisfaction. Additional qualifications for the administrator, including the alternate or other designee, were proposed. An administrator who qualifies under the training and experience qualification also must have a high school diploma or a general equivalency degree (GED). This also is 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 was proposed to allow the supervising nurse to be available in person or via telecommunication, so the supervising nurse can be located at all times. A proposed 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)."

A proposed 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 before 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 was 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 helps ensure higher quality of care and service. DHS also believes 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 were proposed. Language relating to the qualifications for the social worker when performing medical social services is added. The qualifications were inappropriately located in the definitions section. A requirement is been added that unlicensed personnel used 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 were proposed. The term "drug profile" 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 before 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 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 was removed as well. Some of the language relating to volunteers and client rights 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 were proposed. Requirements were 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 were proposed. Client rights specific to home dialysis were moved to Subchapter C and made applicable to all agencies. Requirements were added for having emergency drugs available as specified by the medical director. Standards for performing home dialysis were updated to reflect current standards.

Under DHS's survey procedures, language was 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 CMS or the agency withdraws from the Medicare program, the agency may operate only 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. DHS has had agencies that are licensed with the categories of "licensed and certified" and "personal assistance 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 allows the home health agency to regroup and educate the staff to provide skilled services.

The schedules of administrative penalties were 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 a penalty was 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 were made throughout the rules for the purpose of updating and clarifying language.

DHS received more than 130 written comments from American Habilitation Services, Longview; Christus Santa Rosa HomeCare, San Antonio; Calvert Home Health Care Inc., Lubbock; Quality Infusion Care Inc., Houston; Home and Community Support Services Agencies Advisory Council members; Nurses Today Inc., Dallas; Interim HealthCare, San Antonio, and Interim HealthCare, Corpus Christi; Austin Home Health Care Agency, Austin; Villa Visiting Nurses Home Care, Mt. Pleasant; Doctors Home HealthCare, Fort Worth; Associated Home Care, Terrell; Advanced Patient Care Inc., Beaumont; Texas Children's Home Health Services, Houston; Wilson Memorial Home Health, Floresville; Christus Health, Houston; Allstar Healthcare Inc., Arlington; Texas Association for Home Care, Austin; Allied Primary Home Care, San Antonio; Visiting Nurse Association, Dallas; Concepts of Care, McKinney; and Foundation Management Services Inc., Denton (submitted in conjunction with Covenant Health System). The Covenant Health System includes: Covenant Home Health Care--Lubbock, Covenant Home Health Care--Plainview, Denton Home Health Care--Denton, StarCare Home Health--San Antonio, StarCare Home Nursing--San Antonio, Covenant Home Nursing--Lubbock, Hospice of Lubbock and a number of branches across West and Central Texas. DHS gave all comments serious consideration and responded accordingly. Many comments resulted in changes to the proposed rules.

Most of the commenters were generally against specific sections of the proposed rules as demonstrated in the summary of comments. However, the commenters expressed concerns, offered suggestions, and requested clarification for certain areas of the rules. DHS considered whether the proposal was overly restrictive, and if it would promote the desired outcome and enhance quality of care.

Several parties expressed similar concerns. Comments are combined where appropriate with one response. A summary of the comments and DHS's responses follows.