Comment: Concerning §97.220(a)(2), a commenter noted there may be, as there currently is, an emergency when a HCSSA might provide services outside of its service area. Language should be added for exceptions such as "unless otherwise permitted by these regulations in the event of an emergency."

Response: The agency does not agree with the comment. Section 97.220(c)(2) allows for an extension of a HCSSA's service area without 30 days notice in the event of an emergency. The rule language was not changed in response to this comment.

Comment: Concerning §§97.220(c)(1) and (2), 97.321(c)(3)(A), and 97.322(c)(3)(A), a commenter believed that a requirement for a HCSSA to request expansion of a service area may lead to arbitrary denials of the expansion and wants the language to require only a notice. The commenter cited Senate Bill 983 of the 76th Texas Legislature as saying that it specifically stated that the agency was not to limit service area based on time or distance.

Response: The agency does not agree that a requirement for a HCSSA to request expansion of a service area may lead to arbitrary denials of the expansion. The proposed rule language was intended to prohibit expansion when certain enforcement actions were pending against the HCSSA. Also, Senate Bill 983 of the 76th legislative session asked HHSC to contact the Centers for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration, to request that CMS adopt certain rules concerning HCSSAs. It did not cover state licensing rules. However, the rule language was changed in response to this request to require only a notice. The agency intends to continue further discussion with external stakeholders on this issue.

Comment: Concerning §97.245(b)(5), a commenter asked whether criminal history checks and searches of the nurse aide registry and the employee misconduct registry include independent contractor personnel. Section 97.245 seems to include training requirements for all personnel, including independent contractors, so for safety purposes should these checks not also be conducted.

Response: The agency does not require a HCSSA to perform a criminal history check on employees, volunteers, or contractors of an independent contractor. No change in the rule was made in response to this comment.

Comment: Concerning §97.249(c), a commenter asked in addition to the word "immediately" perhaps a "no later than" time frame should be added to ensure timely communication.

Response: The agency's intent is that a report of abuse, neglect, and exploitation be made as soon as the reporter has "cause to believe" an act of abuse, neglect, or exploitation has occurred as defined in §97.249(a)(2). This is consistent with current rules for other long-term care programs. Using a time frame other than "immediately" could cause reporters to wait to report the act, directly and negatively affecting client health and safety. The rule was not changed in response to this comment.

Comment: Concerning §97.250(a), a commenter noted that a HCSSA's policies must address how it handles both complaints and reports of abuse, neglect, and exploitation. This is not an "either/or" requirement. If "and" is used, it makes it very clear that HCSSA's policy must address both investigation requirements as outlined in the rule under subsections (b) and (c).

Response: The agency agrees with the comment and made a change as suggested to §97.250(a).

Comment: Concerning §97.250(b), a commenter suggested adding the words "For reports of" to subsection (b) to further clarify that the process outlined in paragraphs (1) - (3) is exclusive to the investigation of reports of abuse, neglect, and exploitation and is not applicable to investigations of complaints.

Response: The agency agrees with the comment and made a change to §97.250(b) to reflect that paragraphs (1) - (3) apply only to reports of abuse, neglect, and exploitation.

Comment: Concerning §97.253(d), a commenter asked whether a HCSSA's actual drug testing policy, which might be hard for non-HCSSA personnel to read, or an explanation of that policy must be provided. The commenter favored an explanation of the policy.

Response: The agency disagrees with the comment and the rule language was not changed in response to this comment. The rule was rewritten to require disclosure by the HCSSA of the HCSSA's policies. While there is no requirement in the chapter regarding the quality of HCSSA policies, the policies should be clearly written, in a manner that clients and employees can understand. This rule is based on Health and Safety Code, §142.007, which requires a HCSSA to provide to the following persons a written statement describing the HCSSA's policy for the drug testing of employees who have direct contact with clients: (1) each person applying for services from the HCSSA; and (2) any person requesting the information. The agency's interpretation of §142.007 requires the HCSSA to provide the actual policy rather than an explanation of the policy because the agency thinks it is more useful to persons receiving the information.

Comment: Concerning §97.282(d), a commenter noted that this requirement applies to every category of licensure and suggested that adding the categories would make this clear.

Response: The agency agrees with the comment and added the categories of licensure to §97.282(d).

Comment: Concerning §97.285(2)(A) and (B), a commenter recommended the addition of "as disclosed by the client" to make it clear that personal assistance services agencies are only required to document what was disclosed to them by the client.

Response: The agency added the suggested language to §97.285(2)(B) in response to this comment. Subparagraphs (A) and (B) were reordered to clarify and improve the section.

Comment: Concerning §97.288(a), a commenter believed the rule as proposed implies that the HCSSA should control the coordination of care efforts of other entities involved in the client's care. The rule should be rewritten to state that HCSSA staff must coordinate care with all other service providers, including the physicians, contractors and other agencies.

Response: The agency does not agree with the comment that the rule as proposed implies that the HCSSA must control the coordination of care efforts of other entities. The intent, as in the existing rule and in the proposed language, is that the HCSSA must ensure coordination among all service providers. This concept is not new. However, the agency has made the suggested change to §97.288(a) to clarify the intent of the rule.

Comment: Concerning §97.300, a commenter believed the intent of the rule section has been changed. This rule has always applied to medication administration only. The original language that initiated the subsection formerly stated, "If an agency administers medication to its clients, the agency must adopt and enforce a written policy for maintaining a current medication list and medication administration record." Everything that follows is based on the premise that it is required because medications are being administered. The proposed language takes the medication list out of its original context making this a requirement regardless of whether the HCSSA administers medication. The commenter requests that the agency reorder the language as suggested.

Response: The agency agrees with the comments and has added language to the section so that it applies only to clients to whom agency staff administer medications.

Comment: Concerning §97.301(a)(6)(A)(iii), a commenter expressed that the requirement that a HCSSA obtain a new authorization letter from the physician annually and that a physician's authorization letter is void one year from the date of the letter is overly burdensome with no benefit to equal that burden. The commenter suggested that the rule put the burden on the HCSSA to ensure that doctor's orders are valid and that the fax signature remains valid.

Response: The agency disagrees with the comment. The intent of the rule is that a HCSSA ensure at least annually that the physician is aware of the use of the stamped signature and continues to authorize its use. The rule language was not changed in response to this comment.

Comment: Concerning §97.501(a)(2), a commenter asked if the subsection applies to home health surveys only or to hospice and personal assistance services surveys as well.

Response: The subsection refers to all categories of licensure and no change in the rule was made in response to this comment.

Comment: Concerning §97.501(a)(3) and (4), a commenter requested that the licensure categories be added to the rule for clarity.

Response: The agency agrees with the comment and added the categories of licensure to §97.501(3) and (4) as requested.

Comment: Concerning §97.521(b), a commenter suggested that a HCSSA be required to have admitted a client for the higher-skilled licensure category, even if it is not required to admit a client under every authorized license category.

Response: The agency agrees with the commenter and the rule language was changed in response to this comment to include the requirement that a HCSSA admit a client in the appropriate category. The agency did not use "higher-skilled" because licensure categories are not ranked as higher- or lower-skilled.

Comment: Concerning §97.523(c), a commenter believed that the proposed rule is confusing and unclear. The commenter stated that personal assistance services (PAS) supervisors are not administrative level personnel and should not be required to be available to provide information during the survey.

Response: The agency changed §97.523(c) to delete the requirement that a PAS supervisor must be available to provide information if needed during the survey. The agency intends to continue further discussion with stakeholders on the issue of PAS supervision.

Comment: Concerning §97.525(a)(1)(B), a commenter asked if the rule allows a surveyor to pull records beyond the current survey period. The commenter suggested clarifying language such as "reviews any agency records relevant to the current survey period that the surveyor believes."

Response: The agency's intent is that the surveyor has the ability to fully investigate any and all allegations relevant to the survey or investigation of allegations regardless of the date of the most recent survey. This may include records that were or were not reviewed in a recent survey, but that are relevant to the current survey. The agency does not intend to re-cite deficient practices previously noted in other surveys. The rule language was not changed in response to this comment.

Comment: Concerning §97.527(g)(2)(A), a commenter asked who determines serious harm to a client or a serious threat to the health or safety of a client, and whether there are guidelines to make this determination.

Response: The surveyor, in cooperation with the program manager and other DADS staff, makes the initial determination as to what is a serious threat or actual serious harm to a client. DADS staff use the state licensing rules, the State Operations Manual (for licensed and certified agencies), and survey protocols to make this determination. No change to the rule was made in response to this comment.

Comment: Concerning §97.527(k)(2)(A), a commenter noted that the time frame for compliance is based on a postmark date. Regardless, the HCSSA cannot guarantee receipt at the DADS address.

Response: The agency disagrees with the comment and the rule language was not changed in response to this comment. This requirement is consistent with other long-term care programs. The HCSSA may call DADS to confirm DADS' receipt of the application before the deadline.

Comment: Concerning §97.601(e), a commenter believes the proposed rule goes beyond the intent of the statute, Health and Safety Code, §142.011. The statute clearly states "The department may immediately suspend or revoke a license when the health and safety of persons are threatened." The intent was to give DADS the ability to issue immediate suspensions or revocations based upon a pervasive practice that severely impacted the HCSSA's ability to care for their clients rather than an incident isolated to one client.

Response: The agency does not agree with commenter's interpretation of the intent of Health and Safety Code, §142.011. However, the agency changed the language as requested by the commenter in §97.601(e) to make the rule once again match the statutory language.

Comment: Concerning §97.601(f)(1)(A), a commenter noted that registered or certified mail is used as evidence of DADS notice. Registered or certified mail should be used as the standard as proof for all notices, whether for DADS or the HCSSA.

Response: The agency disagrees with the comment. Section 97.601(f)(1)(A) mirrors Government Code, §2001.054(c)(1), which states the agency gives notice by personal service or by registered or certified mail to the license holder of facts or conduct alleged to warrant the intended action. In other words, this type of notice is required by law in this situation. Historically, the agency has not required license holders to use registered or certified mail when they submit items to the agency, although they are free to do so. Sending notice by registered or certified mail is an added expense that the agency is unwilling to require. The HCSSA may call DADS to confirm DADS' receipt of the material before the deadline. No change to the rule was made in response to this comment.

Comment: Concerning §97.601(g), a commenter believed the proposed language is inconsistent with §97.601(e)(1), which states notice of immediate suspension or revocation will be delivered via certified mail with return receipt requested or by hand-delivery. If the agency is going to group notifications for different types of enforcement action together, then the agency should keep the method of delivery consistent.

Response: The agency agrees with the comment and has made the two provisions for §97.601(e)(1) and §97.601(g) consistent. Under both provisions, notification must be made both by fax and either by certified mail with return receipt requested or hand-delivery.

Comment: Concerning §97.601(h)(4), a commenter believed as a matter of procedure, due process allows a party to request a default judgment from the judge if the party is unable to make it to the hearing. The rule as proposed implies that if a person is unable to make it to the hearing (even if for good cause) the agency will take action as a matter of law. Since this is a matter of procedure, the commenter suggested this would be more appropriately addressed by the HHSC Appeals Division rules or by the State Office of Administrative Hearings rules. If the agency is attempting to let HCSSAs know of potential consequences, the language should be permissive rather than mandatory.

Response: The agency agrees that this language is not appropriately included in these rules and has removed the proposed language from §97.601(h)(4) and renumbered the remaining paragraphs under subsection (h).

Comment: Concerning §97.601(h)(5) and (6), a commenter believed the proposed language in this section is quite different from the present rule. The present language follows Government Code, §2001.054, which speaks to when an adverse action is final. The commenter recommends the agency use the current language located at §97.601(e)(5).

Response: The agency does not agree with the comment. Section 97.601(h)(5) and (6) comply with Government Code, §2001.054, and do not represent a substantive change from the agency's current rule. A HCSSA must continue to make timely renewal applications during the appeal because the license that would be upheld in the appeal is only a one-year license, and a HCSSA must not operate without a valid license. The rule language was not changed in response to this comment.

Comment: Concerning §97.602(b)(2)(A) and (B), a commenter expressed that the degrees of violation are interesting in that they go from minor for a Level A violation to serious harm or death or serious threat to the health or safety of a client with no intermediate level. Perhaps §97.602(b)(2)(B)(iii) "substantially limits the agency's capacity to provide care" could become an intermediate level of violation between levels A and B.

Response: The agency does not agree that the proposed language should be amended based on this comment. Adding an intermediate level of violation would need time for serious study and input from all interested stakeholders. However, an amendment to the rule concerning the possibility for intermediate penalties will be considered at a later date. The rule language was not changed in response to this comment.

Comment: Concerning §97.602(d)(1) and (2), a commenter suggested that the proposed rule goes beyond the statute, Health and Safety Code, §142.017(b), which specifically states the assessments occur after receipt of written notice. Nothing in the statute allows DADS to assess penalties before the written statement of violations is received by the HCSSA. The commenter suggested that DADS utilize the language provided by the commenter, which directly tracks the licensure statute.

Response: The agency agrees with the comment and has amended the language in §97.602(d)(1) and (2) as requested.

Comment: Concerning §97.604(a), a commenter asked if DADS can still take action against the owners of a HCSSA that has a surrendered or expired license and, if so, whether this should be spelled out in the rule.

Response: The rule allows a HCSSA to surrender its license or allow its license to expire to avoid enforcement action by DADS. If a HCSSA surrenders its license in lieu of enforcement action, DADS will not continue to take enforcement action against the owners of a formerly licensed HCSSA. However, in accordance with §97.11(g)(3)(B) and §97.604(c), surrendering or allowing a HCSSA license to expire in lieu of enforcement action is a bar to licensure for 12 months. No change to the rule was made in response to this comment.

Comment: Concerning §97.604(c), a commenter asked if the one-year denial of a licensure application applies if a branch license only is surrendered and a HCSSA wishes to reopen that branch.

Response: The question, as written, appears to assume that enforcement action is taken against the branch license. This assumption is not correct. Enforcement action is taken against the parent license and would continue regardless of branch office closure. The branch office is merely an extension of the parent and should not be considered a separate entity. No change to the rule was made in response to this comment.

In addition, changes were made to clarify §§97.210, 97.291, 97.525, and 97.602.

The change to §97.210(c) added language to clarify that a HCSSA must provide notice of how to contact the person in charge during the HCSSA's operating hours or between 8:00 a.m. to 5:00 p.m., Monday through Friday, if the HCSSA is closed.

The change to §97.291 corrected a cross-reference and the change to §97.525 corrected punctuation to improve the accuracy of the sections.

The change to §97.602(g)(2)(B) corrected the rule language to state that a HCSSA must submit the request for a formal administrative hearing to the Health and Human Services Commission (HHSC), because management of hearings now resides with HHSC.

Because the rule language in §§97.220, 97.321, and 97.322 concerning service areas, §97.300 concerning medication administration, and §97.241 concerning management criteria has been changed, the administrative penalties charts in §97.602(e)(1) and (2) have been updated to reflect those changes.

The amendments are adopted under Texas Government Code, §531.0055, which provides that the HHSC executive commissioner shall adopt rules for the operation and provision of services by the health and human services agencies, including DADS; Texas Human Resources Code, §161.021, which provides that the Aging and Disability Services Council shall study and make recommendations to the HHSC executive commissioner and the DADS commissioner regarding rules governing the delivery of services to persons who are served or regulated by DADS; and Texas Health and Safety Code, Chapter 142, which provides DADS with the authority to adopt rules for licensing and regulation of home and community support services agencies.