Division 1, General Provisions

 

§97.201 Applicability

(a) This subchapter applies to a home and community support services agency providing licensed home health services or licensed and certified home health services with and without home dialysis designation, hospice services, or personal assistance services.

(b) In addition to the minimum standards in this subchapter, an agency must also comply with applicable standards in Subchapter D of this chapter (relating to Additional Standards Specific to License Category and Specific to Special Services) and Subchapter H of this chapter (relating to Standards Specific to Agencies Licensed to Provide Hospice Services).

 

§97.202 Habilitation

(a) An agency may provide habilitation.

(b) An agency that provides habilitation must provide habilitation in accordance with this chapter, including any licensure standards in Subchapter D of this chapter that apply to the categories of service designated on the agency’s license.

 

Division 2, Conditions of License

 

§97.208 Reporting Changes in Application Information and Fees

(a) If certain information provided on an initial or renewal application changes after DADS issues the license, an agency must report the change to DADS. The agency must use the Home and Community Support Services Agency License Application, (DADS Form 2021), to report the change. To avoid a late fee, a change must be reported within the time frame specified for the type of change.

(1) For requirements on reporting a change in the agency's location, see §97.213 of this subchapter (relating to Agency Relocation);

(2) For requirements on reporting a change in the agency's contact information and operating hours, see §97.214 of this subchapter (relating to Notification Procedures for a Change in Agency Contact Information and Operating Hours);

(3) For requirements on reporting a change to the agency's name, see §97.215 of this subchapter (relating to Notification Procedures for an Agency Name Change);

(4) For requirements on reporting a change in the agency's organizational management personnel, see §97.218 of this subchapter (relating to Agency Organizational Changes);

(5) For requirements on adding or deleting a category of service to the license, see §97.219 of this subchapter (relating to Procedures for Adding or Deleting a Category to the License); and

(6) For requirements on expanding or reducing the agency's service area, see §97.220 of this subchapter (relating to Service Areas).

(b) The schedule of fees an agency must pay when the agency timely submits DADS Form 2021 to report changes in application information is as follows.

(1) An agency is not required to pay a fee if the agency reports changes to contact information and operating hours, within the required time frame, as specified in §97.214 of this subchapter.

(2) An agency is not required to pay a fee if the agency reports a change in the alternate administrator, within the required time frame, as specified in §97.218 of this subchapter.

(3) An agency must pay a fee of $30 if the agency, within the required time frame, reports one or more of the following changes:

(A) a change in physical location, as specified in §97.213 of this subchapter;

(B) a change in name (legal entity or doing business as), as specified in §97.215 of this subchapter;

(C) a change in administrator, chief financial officer or controlling person, as specified in §97.218 of this subchapter;

(D) a change in category of service designated on a license, as specified in §97.219 of this subchapter; or

(E) a change in service area, as specified in §97.220 of this subchapter.

(c) If an agency untimely submits DADS Form 2021 to report one or more changes referenced in subsection (a) of this section, the agency must pay a late fee of $100. If an agency must pay a fee of $30 for reporting a change referenced in subsection (b)(3) of this section, the $100 late fee is in addition to the $30 fee.

(d) If DADS determines, based on review of an agency's renewal application, that an agency did not report a change in application information as required by this section, DADS notifies the agency in writing of the fee amount due for payment.

(e) If DADS determines, based on a survey, that an agency did not report a change in application information as required by this section, DADS notifies the agency in writing of the fee amount due for payment. Reporting the change and paying the required fee does not preclude DADS from taking other enforcement action against the agency as specified in §97.601 of this chapter (relating to Enforcement Actions).

(f) If an agency pays a fee to DADS to report a change in application information, the fee is not refundable. DADS accepts payment for a required fee as described in §97.3(f) of this chapter (relating to License Fees).

(g) DADS may suspend or revoke a license or deny an application for a renewal license if an agency does not pay a fee as required by this section within 30 days after DADS provides written notice of a fee amount due for payment. Within 10 days after receipt of DADS written notice of a fee amount due for payment, an agency may submit proof to DADS that the agency:

(1) submitted DADS Form 2021 to timely report a change in application information as specified in each rule referenced in subsection (a) of this section; or

(2) paid the fee amount required by this section when the agency submitted DADS Form 2021.

 

§97.210 Agency Operating Hours

(a) An agency must adopt and enforce a written policy identifying the agency's operating hours.

(b) For the purposes of this section, the person in charge means the administrator, the designated alternate administrator, the supervising nurse, or the alternate supervising nurse.

(c) If an agency is closed during the agency's operating hours or between the hours of 8:00 a.m. and 5:00 p.m. Monday through Friday, the person in charge must:

(1) post a notice in a visible location outside the agency that will provide information regarding how to contact the person in charge; and

(2) leave a message on an answering machine or similar electronic mechanism that will provide information regarding how to contact the person in charge.

 

§97.211 Display of License

The license must be displayed in a conspicuous place in the designated place of business. If the information on the license is officially amended during the licensure period, a notice must be posted beside the license to provide public notice of the change.

 

§97.212 License Alteration Prohibited

A license may not be altered.

 

§97.213 Agency Relocation

(a) An agency must not transfer a license from one location to another without prior notice to DADS. If an agency is considering relocation, the agency must submit written notice to DADS to report a change in physical location at least 30 days before the intended relocation unless DADS grants the agency an exemption from the 30-day time frame as specified in subsection (b) of this section. A change in physical location for a hospice inpatient unit requires DADS to conduct a survey to approve the new location.

(b) An agency must notify DADS immediately if an unexpected situation beyond the agency’s control makes it impossible for the agency to submit written notice to DADS no later than 30 days before the agency relocates. DADS grants or denies the exemption.

(1) If DADS grants the exemption, the agency must submit written notice to DADS as described in subsection (c) of this section within 30 days after the date DADS grants the exemption.

(2) If DADS denies the exemption, the agency may not relocate until at least 30 days after the agency submits the written notice to DADS as described in subsection (c) of this section.

(c) An agency must use the Home and Community Support Services Agency License Application, (DADS Form 2021), to submit the written notice and follow the instructions on the DADS website for reporting a change in physical location.

(d) If an agency reports a change in physical location, the agency must pay a fee and may be subject to a late fee, as described in §97.208 of this subchapter (relating to Reporting Changes in Application Information and Fees).

(e) DADS sends the agency a Notification of Change reflecting the new location. The agency must post the Notification of Change beside its license in accordance with §97.211 of this subchapter (relating to Display of License).

(f) A Medicare certified home health and hospice agency must comply with applicable federal laws and regulations and the requirements of this section for reporting an agency relocation. A change in physical location for a Medicare-certified agency requires DADS review.

(g) An agency is exempt from the requirements in subsections (a)–(d) of this section when reporting a temporary relocation that results from the effects of an emergency or disaster, as specified in §97.256(o) of this subchapter (relating to Emergency Preparedness Planning and Implementation).

 

§97.214 Notification Procedures for a Change in Agency Contact Information and Operating Hours

(a) An agency must submit written notice to DADS no later than seven days after a change in the agency's:

(1) telephone number; or

(2) mailing address, if different than the physical location.

(b) An agency must notify DADS no later than seven days after a change in the agency's operating hours.

(c) An agency must use the Home and Community Support Services Agency License Application, (DADS Form 2021), to submit the written notice and follow the instructions on DADS website for reporting the changes described in subsections (a) and (b) of this section.

(d) If an agency reports the information after the timeframes required by this section, the agency must pay a late fee as described in §97.208 of this subchapter (relating to Reporting Changes in Application Information and Fees).

 

§97.215 Notification Procedures for an Agency Name Change

 

(a) If an agency intends to change its name (legal entity or doing business as), but does not undergo a change of ownership as defined in §97.23(b) of this chapter (relating to Change of Ownership), the agency must report the name change to DADS no later than seven days after the effective date of the name change.

(b) An agency must use the Home and Community Support Services Agency License Application, (DADS Form 2021), to submit the written notice and follow the instructions on DADS website for reporting a name change.

(c) If an agency reports a name change, the agency must pay a fee and may be subject to a late fee, as described in §97.208 of this subchapter (relating to Reporting Changes in Application Information and Fees).

(d) After DADS receives and verifies the required documents and information, DADS sends the agency a Notification of Change reflecting the agency's new name. The agency must post the Notification of Change beside its license in accordance with §97.211 of this subchapter (relating to Display of License).

 

§97.216 Change in Agency Certification Status

 

(a) An agency must notify DADS in writing no later than five days after the agency decides to voluntarily withdraw from the Medicare Program. If an agency's voluntary withdrawal from the Medicare Program is based on the permanent closure of the agency, the agency must also comply with §97.217 of this subchapter (relating to Agency Closure Procedures and Voluntary Suspension of Operations).

(b) If an agency chooses to voluntarily withdraw from the Medicare Program, or if CMS involuntarily terminates or denies its certification, the license will be affected as follows:

(1) If an agency licensed to provide licensed and certified home health services has no other license categories remaining on the license after losing its Medicare certification, its license is void and the agency must cease operation. If the agency wants to resume providing services, it must apply for an initial license.

(2) If a Medicare-certified agency has another license category remaining on the current license and the agency wants to continue providing services under the remaining license category, DADS surveys the agency under the remaining license category.

(c) As specified in §97.601(c)(2) of this chapter (relating to Enforcement Actions), DADS may take enforcement action against an agency licensed to provide licensed and certified home health services if the agency fails to maintain its Medicare certification. The agency may request an administrative hearing in accordance with §97.601 of this chapter to contest the enforcement action taken by DADS against the agency.

 

§97.217 Agency Closure Procedures and Voluntary Suspension of Operations

 

(a) Permanent closure. An agency must notify DADS in writing within five days before the permanent closure of the agency, branch office, or alternate delivery site.

(1) The agency must include in the written notice the reason for closing, the location of the client records (active and inactive), and the name and address of the client record custodian.

(2) If the agency closes with an active client roster, the agency must transfer a copy of the active client record with the client to the receiving agency in order to ensure continuity of care and services to the client.

(3) The agency must mail or return the initial license or renewal license to DADS at the end of the day that services ceased.

(4) If an agency continues to operate after the closure date specified in the notice, DADS may take enforcement action against the agency.

(b) Applicability. This subsection applies to an agency licensed to provide licensed home health services, personal assistance services, and licensed-only hospice services.

(1) Voluntary suspension of operations occurs when an agency voluntarily suspends its normal business operations for 10 or more consecutive days. A voluntary suspension of operations may not last longer than the licensure renewal period. If an agency voluntarily suspends operations, the agency must:

(A) discharge or arrange for backup services for active clients;

(B) provide written notification to the designated survey office at least five days before the voluntary suspension of operations or within two working days before the voluntary suspension of operations if an emergency occurs that is beyond the agency's control; and

(C) post a notice of voluntary suspension of operations on the entry door of the agency and leave a message on an answering machine or with an answering service that informs callers of the voluntary suspension of operations.

(2) An agency must notify the Home and Community Support Services Agencies Licensing Unit in writing no later than seven days after resuming operations.

 

§97.218 Agency Organizational Changes

 

(a) If a change occurs in the following management personnel, an agency must submit written notice to DADS no later than seven days after the date of a change in:

(1) administrator;

(2) alternate administrator;

(3) chief financial officer; or

(4) controlling person, as defined in §97.2 of this chapter (relating to Definitions).

(b) An agency must use the Home and Community Support Services Agency License Application, (DADS Form 2021), to submit the written notice and follow the instructions on DADS website for reporting a change in the management personnel listed in subsection (a) of this section.

(c) If an agency reports a change in the administrator, chief financial officer or controlling person, the agency must pay a fee and may be subject to a late fee, as described in §97.208 of this subchapter (relating to Reporting Changes in Application Information and Fees).

(d) An agency is not required to pay a fee to report a change in alternate administrator, but the agency must pay a late fee, as described in §97.208 of this subchapter, if the agency does not report the change within the time frame required in this section.

(e) A change in the management personnel listed in subsection (a) of this section requires DADS evaluation and approval. DADS reviews the required documents and information submitted. DADS notifies an agency if the information the agency provides does not reflect that a person listed in subsection (a)(1)-(4) of this section meets the required qualifications.

 

§97.219 Procedures for Adding or Deleting a Category to the License

 

(a) To add or delete a category of service to a license, an agency must submit written notice to DADS at least 30 days before the addition or deletion of the category.

(b) DADS either approves or denies the addition of a category of service no later than 30 days after DADS receives the written notice. An agency must not provide the services under the category the agency is adding until the agency receives written notice of approval from DADS.

(1) To add a category of service to a license, an agency must:

(A) be in substantial compliance with the statute and this chapter; and

(B) have no enforcement action pending against the license.

(2) If DADS denies the addition of a category of service, DADS informs the agency of the reason for denial.

(3) DADS may conduct a survey after the approval of a category.

(c) DADS receipt of a request to delete a category from a license does not preclude DADS from taking enforcement action as appropriate in accordance with Subchapter F of this chapter (relating to Enforcement).

(d) An agency must use the Home and Community Support Services Agency License Application, (DADS Form 2021), to submit the written notice and follow the instructions on DADS website for requesting to add or delete a category of service.

(e) If an agency reports a change in a category of service, the agency must pay a fee and may be subject to a late fee, as described in §97.208 of this subchapter (relating to Reporting Changes in Application Information and Fees).

(f) When DADS adds or deletes a category of service, DADS sends the agency a Notification of Change reflecting the change in the category of service. The agency must post the Notification of Change beside its license in accordance with §97.211 of this subchapter (relating to Display of License).

 

§97.220 Service Areas

 

(a) An agency must identify its licensed service area. A branch office or alternate delivery site must be located within the parent agency's licensed service area. An agency must not provide services outside its licensed service area, except as provided in subsections (i) and (j) of this section.

(b) An agency must maintain adequate staff to provide services and to supervise the provision of services.

(c) An agency may expand its service area at any time during the licensure period. An agency must submit written notice to DADS to expand the agency's service area at least 30 days before the expansion unless DADS grants the agency an exemption from the 30-day time frame as specified in subsection (d) of this section.

(d) An agency is exempt from the requirement to submit written notice to DADS no later than 30 days before the agency expands its service area if DADS determines an emergency situation exists that would affect client health and safety.

(1) An agency must notify DADS immediately of a possible emergency situation that would affect client health and safety.

(2) DADS grants or denies an exemption from the 30-day written notice requirement.

(A) If DADS grants an exemption, the agency must submit written notice to DADS, as described in subsection (e) of this section, no later than 30 days after the date DADS grants the exemption.

(B) If DADS denies an exemption, the agency may not expand agency's service area until at least 30 days after the agency submits the written notice to DADS as described in subsection (e) of this section.

(e) If an agency intends to expand or reduce the agency's service area, the agency must submit written notice to DADS by using the Home and Community Support Services Agency License Application, (DADS Form 2021), following the instructions on the DADS website for requesting to expand or reduce the agency's service area.

(f) If an agency reports a change in service area, the agency must pay a fee and may be subject to a late fee, as described in §97.208 of this subchapter (relating to Reporting Changes in Application Information and Fees).

(g) An agency may reduce its service area at any time during the licensure period. An agency must submit written notice to DADS informing DADS that the agency reduced its service area no later than 10 days after the reduction.

(h) DADS sends the agency a Notification of Change reflecting the change in service area. An agency is not required to post the Notification of Change in service area beside its license.

(i) An agency is exempt from the requirements described in subsections (c)-(f) of this section if a temporary expansion results from an emergency or disaster, as specified in §97.256(o) of this subchapter (relating to Emergency Preparedness Planning and Implementation).

(j) An agency may provide services to a client outside the agency’s licensed service area but within the state of Texas in accordance with this subsection and, for an agency licensed to provide hospice services, the additional standards in §97.830 of this chapter (relating to Provision of Hospice Core Services).

(1) The agency may provide the services for no more than 60 consecutive days unless the agency expands its service area as described in subsections (e) and (f) of this section, except the written notice to DADS must be postmarked no later than the 60th day to comply with this subsection and avoid a late fee.

(2)The client must reside in the agency’s service area and be receiving services from the agency at the time the client leaves the agency’s service area.

(3)The agency must maintain compliance with the statute and this chapter and, if applicable, federal home health and hospice regulations.

(4)The agency must document in the client record the start and end dates for the services.

(5)An agency's ability to provide services to a client outside its service area may depend on regulations or requirements established by the client's private or public funding source, including a health maintenance organization or other private third-party insurance, Medicaid (Title XIX of the Social Security Act), Medicare (Title XVIII of the Social Security Act), or a state-funded program. The agency is responsible for knowing these requirements.

(k) If a client notifies an agency that the client is leaving the agency’s service area and the agency does not provide services in accordance with subjection (j), the agency must inform the client that leaving its service area will require the agency to:

(1) place the client's services on hold in accordance with the agency's written policy required by §97.281 of this subchapter (relating to Client Care Policies) until the client returns to the agency's service area;

(2) transfer and discharge the client in accordance with §97.295 of this subchapter (relating to Client Transfer or Discharge Notification Requirements) and the agency's written policy required by §97.281 of this subchapter; or

(3) discharge the client in accordance with §97.295 of this subchapter and the agency's written policy required by §97.281 of this subchapter.

 

§97.222 Compliance

 

An agency must maintain satisfactory compliance with all the provisions of the statute and this chapter to maintain licensure.

 

Division 3, Agency Administration

§97.241 Management

 

(a) Agency policies. The license holder is responsible for the conduct of the agency and for adoption, implementation, enforcement and monitoring of adherence to the written policies required throughout this chapter. The license holder is also responsible for ensuring that these policies comply with the statute and the applicable provisions of this chapter and are administered to provide safe, professional, quality health care.

(b) Criminal conviction. The persons described in §97.11(g) of this chapter (relating to Criteria and Eligibility for Licensing) must not have been convicted of an offense described in Chapter 99 of this title (relating to Criminal Convictions Barring Facility Licensure), during the time frames described in that chapter.

(c) Documentation. The license holder must ensure that all documents submitted to DADS or maintained by the agency pursuant to this chapter are accurate and do not misrepresent or conceal a material fact.

(d) Compliance with enforcement orders. The license holder must comply with an order of the DADS commissioner or other enforcement orders that may be imposed on the agency in accordance with the statute and this chapter.

 

§97.242 Organizational Structure and Lines of Authority

 

(a) An agency must prepare and maintain a current written description of the agency's organizational structure. The document may be either in the form of a chart or a narrative.

(b) The description must include:

(1) all services provided by the agency;

(2) the governing body, the administrator, the supervising nurse, advisory committee, interdisciplinary team, and staff, as appropriate, based on services provided by the agency; and

(3) the lines of authority and the delegation of responsibility down to and including the client care level.

 

§97.243 Administrative and Supervisory Responsibilities

 

(a) Administrative responsibilities.

(1) A license holder or the license holder's designee must designate an individual who meets the qualifications and conditions set out in §97.244 of this chapter (relating to Administrator Qualifications and Conditions and Supervising Nurse Qualifications) to serve as the administrator of the agency.

(2) A license holder or the license holder's designee must designate in writing an alternate administrator who meets the qualifications and conditions of an administrator to act in the absence of the administrator.

(b) Administrator responsibilities.

(1) An administrator must be responsible for implementing and supervising the administrative policies and operations of the agency and for administratively supervising the provision of all services to agency clients on a day-to-day basis. An administrator must:

(A) manage the daily operations of the agency;

(B) organize and direct the agency's ongoing functions;

(C) administratively supervise the provision of quality care to agency clients;

(D) supervise to ensure implementation of agency policy and procedures;

(E) ensure that the documentation of services provided is accurate and timely;

(F) employ or contract with qualified personnel;

(G) ensure adequate staff education and evaluations according to requirements in §97.245(b) of this chapter (relating to Staffing Policies);

(H) ensure the accuracy of public information materials and activities;

(I) implement an effective budgeting and accounting system that promotes the health and safety of the agency's clients; and

(J) supervise and evaluate client satisfaction survey reports on all clients served.

(2) An administrator or alternate administrator must be available to agency personnel in person or by telephone during the agency's operating hours and in accordance with the rules in this chapter, including §97.210 of this subchapter (relating to Agency Operating Hours), §97.404(h)(2) of this chapter (relating to Standards Specific to Agencies Licensed to Provide Personal Assistance Services), §97.523 of this chapter (relating to Personnel Requirements for a Survey), and §97.527 of this chapter (relating to Post-Survey Procedures).

(3) An administrator must designate in writing an agency employee who must provide DADS surveyors entry to the agency in accordance with §97.523(e) of this chapter (relating to Personnel Requirements for a Survey) if the administrator and alternate administrator are not available.

(c) Supervision of services.

(1) Except as provided in paragraph (3) of this subsection, an agency licensed to provide licensed home health services, licensed and certified home health services, or hospice services must directly employ or contract with an individual who meets the qualifications in §97.244 of this chapter to serve as the supervising nurse.

(2) An agency must designate in writing a similarly qualified alternate to serve as supervising nurse in the absence of the supervising nurse.

(A) The supervising nurse or alternate supervising nurse must:

(i) be available to agency personnel at all times in person or by telephone;

(ii) participate in activities relevant to services furnished, including the development of qualifications and assignment of agency personnel;

(iii) ensure that a client's plan of care or care plan is executed as written; and

(iv) ensure that an appropriate health care professional performs a reassessment of a client's needs:

(I) when there is a significant health status change in the client's condition;

(II) at the physician's request; or

(III) after hospital discharge

(B) A supervising nurse may also be the administrator of the agency if the supervising nurse meets the qualifications and conditions of an administrator described in §97.244(a) and (b) of this chapter.

(3) An agency that provides only physical, occupational, speech or respiratory therapy, medical social services, or nutritional counseling is not required to employ or contract with a supervising nurse. A qualified licensed professional must supervise these services, as applicable.

(d) Supervision of branch offices and alternate delivery sites. An agency must adopt and enforce a written policy relating to the supervision of branch offices or alternate delivery sites, if established. This policy must be consistent with the following:

(1) for a branch office, §97.27 of this chapter (relating to Application and Issuance of a Branch Office License) and §97.321 of this chapter (relating to Standards for Branch Offices);

(2) for an alternate delivery site, §97.29 of this chapter (relating to Application and Issuance of an Alternate Delivery Site License) and §97.322 of this chapter (relating to Standards for Alternate Delivery Sites).

 

§97.244 Administrator Qualifications and Conditions and Supervising Nurse Qualifications

 

(a) Administrator qualifications.

(1) For an agency licensed to provide licensed home health services, licensed and certified home health services, or hospice services, the administrator and the alternate administrator must:

(A) be a licensed physician, registered nurse, licensed social worker, licensed therapist, or licensed nursing home administrator with at least one year of management or supervisory experience in a health-related setting, such as:

(i) a home and community support services agency;

(ii) a hospital;

(iii) a nursing facility;

(iv) a hospice;

(v) an outpatient rehabilitation center;

(vi) a psychiatric facility;

(vii) an intermediate care facility for individuals with an intellectual disability or related conditions; or

(viii) a licensed health care delivery setting providing services for individuals with functional disabilities; or

(B) have a high school diploma or a general equivalency degree (GED) with at least two years of management or supervisory experience in a health-related setting, such as:

(i) a home and community support services agency;

(ii) a hospital;

(iii) a nursing facility;

(iv) a hospice;

(v) an outpatient rehabilitation center;

(vi) a psychiatric facility;

(vii) an intermediate care facility for individuals with an intellectual disability or related conditions; or

(viii) a licensed health care delivery setting providing services for individuals with functional disabilities.

(2) For an agency licensed to provide hospice services, in addition to the qualifications listed in paragraph (1)(A) or (B) of this subsection, the administrator and the alternate administrator must:

(A) be a hospice employee; and

(B) have any additional education and experience required by the hospice's governing body as specified in the agency's job description.

(3) For an agency licensed to provide only personal assistance services, the administrator and the alternate administrator must meet at least one of the following qualifications:

(A) have a high school diploma or a GED with at least one year experience or training in caring for individuals with functional disabilities;

(B) have completed two years of full-time study at an accredited college or university in a health-related field; or

(C) meet the qualifications listed in paragraph (1)(A) or (B) of this subsection.

(b) Administrator conditions.

(1) An administrator and alternate administrator must be able to read, write, and comprehend English.

(2) An administrator and alternate administrator designated as an administrator or alternate administrator for the first time on or after December 1, 2006, must meet the initial educational training requirements specified in §97.259 of this subchapter (relating to Initial Educational Training in Administration of Agencies).

(3) An administrator and alternate administrator designated as an administrator or alternate administrator before December 1, 2006, must meet the continuing education requirements specified in §97.260 of this subchapter (relating to Continuing Education in Administration of Agencies).

(4) A person is not eligible to be the administrator or alternate administrator of any agency if the person was the administrator of an agency cited with a violation that resulted in DADS taking enforcement action against the agency while the person was the administrator of the cited agency.

(A) This paragraph applies for 12 months after the date of the enforcement action.

(B) For purposes of this paragraph, enforcement action means license revocation, suspension, emergency suspension of a license, denial of an application for a license, or the imposition of an injunction but does not include administrative or civil penalties.

(C) If DADS prevails in one enforcement action against the agency and also proceeds with, but does not prevail in, another enforcement action based on some or all of the same violations, this paragraph does not apply.

(5) An administrator and alternate administrator must not be convicted of an offense described in Chapter 99 of this title (relating to Denial or Refusal of License) during the time frames described in that chapter.

(c) Supervising nurse qualifications.

(1) For an agency without a home dialysis designation, a supervising nurse and alternate supervising nurse must each:

(A) be a registered nurse (RN) licensed in Texas or in accordance with the Texas Board of Nursing rules for Nurse Licensure Compact (NLC); and

(B) have at least one year experience as an RN within the last 36 months.

(2) For an agency with home dialysis designation, a supervising nurse and alternate supervising nurse must each:

(A) be an RN licensed in Texas or in accordance with the Texas Board of Nursing rules for NLC, and:

(i) have at least three years of current experience in hemodialysis; or

(ii) have at least two years of experience as an RN and hold a current certification from a nationally recognized board in nephrology nursing or hemodialysis; or

(B) be a nephrologist or physician with training or demonstrated experience in the care of ESRD clients.

 

§97.245 Staffing Policies

 

(a) An agency must adopt and enforce staffing policies that govern all personnel used by the agency, including employees, volunteers and contractors.

(b) An agency's written staffing policies must:

(1) include requirements for orientation to the policies, procedures, and objectives of the agency;

(2) include requirements for participation by all personnel in job-specific training. Agency training program policies must:

(A) ensure personnel are properly oriented to tasks performed;

(B) ensure demonstration of competency for tasks when competency cannot be determined through education, license, certification or experience;

(C) ensure a continuing systematic program for the training of all personnel; and

(D) ensure personnel are informed of changes in techniques, philosophies, goals, client's rights, and products relating to client's care;

(3) address participation by all personnel in appropriate employee development programs;

(4) include a written job description (statement of those functions and responsibilities which constitute job requirements) and job qualifications (specific education and training necessary to perform the job) for each position within the agency;

(5) include procedures for processing criminal history checks and searches of the nurse aide registry and the employee misconduct registry for unlicensed personnel in accordance with §97.247 of this subchapter (relating to Employability and Use of Unlicensed Persons);

(6) ensure annual evaluation of employee and volunteer performance;

(7) address employee and volunteer disciplinary action and procedures;

(8) if volunteers are used by the agency, address the use of volunteers. The policy must be in compliance with §97.248 of this subchapter (relating to Volunteers);

(9) address requirements for providing and supervising services to pediatric clients. Services provided to pediatric clients must be provided by staff who have been instructed and have demonstrated competency in the care of pediatric clients; and

(10) include a requirement that all personnel who are direct care staff and who have direct contact with clients (employed by or under contract with the agency) sign a statement that they have read, understand, and will comply with all applicable agency policies.

 

§97.246 Personnel Records

 

(a) An agency must maintain a personnel record for an employee and volunteer. A personnel record may be maintained electronically if it meets the same requirements as a paper record. All information must be kept current. A personnel record must include the following:

(1) a signed job description and qualifications for each position accepted or a signed statement that the person read the job description and qualifications for each position accepted;

(2) an application for employment or volunteer agreement;

(3) verification of license, permits, references, job experience, and educational requirements as conducted by the agency to verify qualifications for each position accepted;

(4) performance evaluations and disciplinary actions;

(5) the signed statement about compliance with agency policies required by §97.245(b)(10) of this subchapter (relating to Staffing Policies), if applicable; and

(6) for an unlicensed employee and unlicensed volunteer whose duties would or do include face-to-face contact with a client:

(A) a printed copy of the results of the initial and annual searches of the nurse aide registry (NAR) and employee misconduct registry (EMR) obtained from the DADS Internet website; and

(B) documentation that the employee, in accordance with §97.247(a)(4) of this subchapter (relating to Verification of Employability and Use of Unlicensed Persons), or volunteer, in accordance with §97.247(b)(4), received written information about the EMR.

(b) An agency may keep a complete and accurate personnel record for an employee and volunteer in any location as determined by the agency. An agency must provide personnel records not stored at the site of a survey upon request by a DADS' surveyor as specified in §97.507(c) of this chapter (relating to Agency Cooperation with a Survey).

 

§97.247 Verification of Employability and Use of Unlicensed Persons

 

(a) The provisions in this subsection apply to an unlicensed applicant for employment and an unlicensed employee, if the person’s duties would or do include face-to-face contact with a client.

(1) An agency must conduct a criminal history check authorized by, and in compliance with, Texas Health and Safety Code (THSC), Chapter 250 (relating to Nurse Aide Registry and Criminal History Checks of Employees and Applicants for Employment in Certain Facilities Serving the Elderly or Persons with Disabilities) for an unlicensed applicant for employment and an unlicensed employee.

(2) The agency must not employ an unlicensed applicant whose criminal history check includes a conviction listed in THSC §250.006 that bars employment or a conviction the agency has determined is a contraindication to employment. If an applicant's or employee's criminal history check includes a conviction of an offense that is not listed in THSC §250.006, the agency must document its review of the conviction and its determination of whether the conviction is a contraindication to employment.

(3) Before the agency hires an unlicensed applicant, or before an unlicensed employee’s first face-to-face contact with a client, the agency must search the nurse aide registry (NAR) and the employee misconduct registry (EMR) using the DADS Internet website to determine if the applicant or employee is listed in either registry as unemployable. The agency must not employ an unlicensed applicant who is listed as unemployable in either registry.

(4) The agency must provide written information about the EMR to an unlicensed employee in compliance with the requirements of §93.3(c) of this title (relating to Employment and Registry Information).

(5) In addition to the initial verification of employability, the agency must search the NAR and the EMR to determine if the employee is listed as unemployable in either registry as follows:

(A) for an employee most recently hired before September 1, 2009, by August 31, 2011, and at least every twelve months thereafter; and

(B) for an employee most recently hired on or after September 1, 2009, at least every 12 months.

(6) The agency must immediately discharge an unlicensed employee whose duties would or do include face-to-face contact with a client when the agency becomes aware:

(A) that the employee is designated in the NAR or the EMR as unemployable; or

(B) that the employee’s criminal history check reveals conviction of a crime that bars employment or that the agency has determined is a contraindication to employment.

(b) The provisions in this subsection apply to an unlicensed volunteer, if the person’s duties would or do include face-to-face contact with a client.

(1) An agency must conduct a criminal history check before an unlicensed volunteer’s first face-to-face contact with a client of the agency.

(2) The agency must not use the services of an unlicensed volunteer for duties that would or do include face-to-face contact with a client whose criminal history information includes a conviction that bars employment under THSC §250.006 or a conviction the agency has determined is a contraindication to employment. If an unlicensed volunteer's criminal history check includes a conviction of an offense not listed in THSC §250.006, the agency must document its review of the conviction and its determination of whether the conviction is a contraindication to employment.

(3) Before an unlicensed volunteer’s first face-to-face contact with a client, the agency must conduct a search of the NAR and the EMR using the DADS Internet website to determine if an unlicensed volunteer is listed in either registry as unemployable. The agency must not use the services of an unlicensed volunteer who is listed as unemployable in either registry.

(4) The agency must provide written information about the EMR that complies with the requirements of §93.3(c) of this title to an unlicensed volunteer within five working days from the date of the person's first face-to-face contact with a client.

(5) In addition to the initial verification of employability, the agency must search the NAR and the EMR to determine if a volunteer is designated in either registry as unemployable, as follows:

(A) for a volunteer with face-to-face contact with a client for the first time before September 1, 2009, by August 31, 2011, and at least every twelve months thereafter; and

(B) for a volunteer with face-to-face contact with a client for the first time on or after September 1, 2009, at least every twelve months.

(6) The agency must immediately stop using the services of an unlicensed volunteer for duties that would or do include face-to-face contact with a client when the agency becomes aware:

(A) that the unlicensed volunteer is designated in the NAR or the EMR as unemployable; or

(B) that the unlicensed volunteer’s criminal history check reveals conviction of a crime that bars employment or that the agency has determined is a contraindication to employment.

(c) Upon request by DADS, an agency must provide documentation to demonstrate compliance with subsections (a) and (b) of this section.

(d) An agency that contracts with another agency or organization for an unlicensed person to provide home health services, hospice services, or personal assistance services under arrangement must also comply with the requirements in §97.289(c)-(d) of this subchapter (relating to Independent Contractors and Arranged Services).

 

§97.248 Volunteers

 

(a) This section applies to all licensed agencies. However, agencies certified by CMS to provide hospice services also must comply with 42 CFR, §418.78, Conditions of Participation — Volunteers.

(b) If an agency uses volunteers, the agency must use volunteers in defined roles under the supervision of a designated agency employee.

(1) A volunteer must meet the same requirements and standards in this chapter that apply to agency employees performing the same activities.

(2) An agency may use volunteers in administrative and direct client care roles.

(3) Volunteers must document services provided to a client and, if applicable, services provided to the client's family.

 

§97.249 Self-Reported Incidents of Abuse, Neglect, and Exploitation

 

(a) The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise.

(1) Abuse, neglect, and exploitation of a client 18 years of age and older have the meanings assigned by the Texas Human Resources Code, §48.002.

(2) Abuse, neglect, and exploitation of a child have the meanings assigned by the Texas Family Code, §261.401.

(3) Employee means an individual directly employed by an agency, a contractor, or a volunteer.

(4) Cause to believe means that an agency knows, suspects, or receives an allegation regarding abuse, neglect, or exploitation.

(b) An agency must adopt and enforce a written policy relating to the agency’s procedures for reporting alleged acts of abuse, neglect, and exploitation of a client by an employee of the agency.

(c) If an agency has cause to believe that a client served by the agency has been abused, neglected, or exploited by an agency employee, the agency must report the information immediately, meaning within 24 hours, to:

(1) the Department of Family and Protective Services (DFPS) at 1-800-252-5400, or through the DFPS secure website at www.txabusehotline.org; and

(2) DADS at 1-800-458-9858.

 

§97.250 Agency Investigations

 

(a) Written policy.

(1) An agency must adopt and enforce a written policy relating to the agency's procedures for investigating complaints and reports of abuse, neglect, and exploitation.

(2) The policy must meet the requirements of this section.

(b) Reports of abuse, neglect, and exploitation (ANE).

(1) Immediately upon witnessing the act or upon receipt of the allegation, an agency must initiate an investigation of known and alleged acts of ANE by agency employees, including volunteers and contractors.

(2) An agency must complete DADS' Provider Investigation Report form and include the following information:

(A) incident date;

(B) the alleged victim;

(C) the alleged perpetrator;

(D) any witnesses;

(E) the allegation;

(F) any injury or adverse affect;

(G) any assessments made;

(H) any treatment required;

(I) the investigation summary; and

(J) any action taken.

(3) An agency must send the completed DADS’ Provider Investigation Report form to DADS’ Complaint Intake Unit no later than the 10th day after reporting the act to the Department of Family and Protective Services and DADS.

(c) Agency complaint investigations.

(1) An agency must investigate complaints made by a client, a client's family or guardian, or a client's health care provider, in accordance with this subsection, regarding:

(A) treatment or care that was furnished by the agency;

(B) treatment or care that the agency failed to furnish; or

(C) a lack of respect for the client's property by anyone furnishing services on behalf of the agency.

(2) An agency must:

(A) document receipt of the complaint and initiate a complaint investigation within 10 days after the agency's receipt of the complaint; and

(B) document all components of the investigation.

(d) Completing agency investigations. An agency must complete the investigation and documentation within 30 days after the agency receives a complaint or report of abuse, neglect, and exploitation, unless the agency has and documents reasonable cause for a delay.

(e) Retaliation.

(1) An agency may not retaliate against a person for filing a complaint, presenting a grievance, or providing, in good faith, information relating to home health, hospice, or personal assistance services provided by the agency.

(2) An agency is not prohibited from terminating an employee for a reason other than retaliation.

 

§97.251 Peer Review

 

An agency must adopt and enforce a written policy to ensure that all professional disciplines comply with their respective professional practice acts or title acts relating to reporting and peer review.

 

§97.252 Financial Solvency and Business Records

 

An agency must have the financial ability to carry out its functions.

(1) An agency must not intentionally or knowingly pay employees or contracted staff with checks from accounts with insufficient funds.

(2) An agency must have sufficient funds to meet its payroll.

(3) An agency must make available to DADS upon request business records relating to its ability to carry out its functions. If there is a question relating to the accuracy of the records or the agency's financial ability to carry out its functions, DADS or its designee may conduct a more extensive review of the records.

(4) An agency must maintain business records in their original state. Each entry must be accurate and dated with the date of entry. Correction fluid or tape may not be used in the record. Corrections must be made in accordance with standard accounting practices.

 

§97.253 Disclosure of Drug Testing Policy

 

(a) An agency must have a written policy describing whether it will conduct drug testing of its employees who have direct contact with clients.

(b) If an agency conducts drug testing, the written policy must describe the method by which drug testing is conducted.

(c) If an agency does not practice drug testing of its employees, the written policy must state that the agency does not conduct drug testing of its employees.

(d) An agency must provide a copy of the policy to anyone applying for services from the agency and any person who requests it.

 

§97.254 Billing and Insurance Claims

 

The agency must adopt and enforce a written policy to ensure that the agency submits accurate billings and insurance claims.

 

§97.255 Prohibition of Solicitation of Patients

 

(a) An agency must adopt and enforce a written policy to ensure compliance of the agency and its employees and contractors with the Texas Occupations Code, Chapter 102 (relating to Solicitation of Patients). For the purpose of this section a patient is considered to be a client.

(b) DADS may take enforcement action against an agency in accordance with §97.601 of this chapter (relating to Enforcement Actions) and §97.602 of this chapter (relating to Administrative Penalties), if the agency violates Texas Occupations Code, §102.001 (relating to Soliciting Patients; Offense) or §102.006 (relating to Failure to Disclose; Offense).

 

§97.256 Emergency Preparedness Planning and Implementation

 

(a) An agency must have a written emergency preparedness and response plan that comprehensively describes its approach to a disaster that could affect the need for its services or its ability to provide those services. The written plan must be based on a risk assessment that identifies the disasters from natural and man-made causes that are likely to occur in the agency's service area. With the exception of a freestanding hospice inpatient unit, DADS does not require an agency to physically evacuate or transport a client.

(b) Agency personnel that must be involved with developing, maintaining, and implementing an agency's emergency preparedness and response plan include:

(1) the administrator;

(2) the supervising nurse, if the agency is required to employ or contract with a supervising nurse as required by §97.243 of this subchapter (relating to Administrative and Supervisory Responsibilities);

(3) the agency disaster coordinator; and

(4) the alternate disaster coordinator.

(c) An agency's written emergency preparedness and response plan must:

(1) designate, by title, an employee, and at least one alternate employee to act as the agency's disaster coordinator;

(2) include a continuity of operations business plan that addresses emergency financial needs, essential functions for client services, critical personnel, and how to return to normal operations as quickly as possible;

(3) include how the agency will monitor disaster-related news and information, including after hours, weekends, and holidays, to receive warnings of imminent and occurring disasters;

(4) include procedures to release client information in the event of a disaster, in accordance with the agency's written policy required by §97.301(a)(2) of this subchapter (relating to Client Records); and

(5) describe the actions and responsibilities of agency staff in each phase of emergency planning, including mitigation, preparedness, response, and recovery.

(d) The response and recovery phases of the plan must describe:

(1) the actions and responsibilities of agency staff when warning of an emergency is not provided;

(2) who at the agency will initiate each phase;

(3) a primary mode of communication and alternate communication or alert systems in the event of telephone or power failure; and

(4) procedures for communicating with:

(A) staff;

(B) clients or persons responsible for a client's emergency response plan;

(C) local, state, and federal emergency management agencies; and

(D) other entities including DADS and other healthcare providers and suppliers.

(e) An agency's emergency preparedness and response plan must include procedures to triage clients that allow the agency to:

(1) readily access recorded information about an active client's triage category in the event of an emergency to implement the agency's response and recovery phases, as described in subsection (d) of this section; and

(2) categorize clients into groups based on:

(A) the services the agency provides to a client;

(B) the client's need for continuity of the services the agency provides; and

(C) the availability of someone to assume responsibility for a client's emergency response plan if needed by the client.

(f) The agency's emergency preparedness and response plan must include procedures to identify a client who may need evacuation assistance from local or state jurisdictions because the client:

(1) cannot provide or arrange for his or her transportation; or

(2) has special health care needs requiring special transportation assistance.

(g) If the agency identifies a client who may need evacuation assistance, as described in subsection (f) of this section, agency personnel must provide the client with the amount of assistance the client requests to complete the registration process for evacuation assistance if the client:

(1) wants to register with the Transportation Assistance Registry, accessed by dialing 2-1-1; and

(2) is not already registered, as reported by the client or legally authorized representative.

(h) An agency must provide and discuss the following information about emergency preparedness with each client:

(1) the actions and responsibilities of agency staff during and immediately following an emergency;

(2) the client's responsibilities in the agency's emergency preparedness and response plan;

(3) materials that describe survival tips and plans for evacuation and sheltering in place; and

(4) a list of community disaster resources that may assist a client during a disaster, including the Transportation Assistance Registry available through 2-1-1 Texas, and other community disaster resources provided by local, state, and federal emergency management agencies. An agency's list of community disaster resources must include information on how to contact the resources directly or instructions to call 2-1-1 for more information about community disaster resources.

(i) An agency must orient and train employees, volunteers, and contractors about their responsibilities in the agency's emergency preparedness and response plan.

(j) An agency must complete an internal review of the plan at least annually, and after each actual emergency response, to evaluate its effectiveness and to update the plan as needed.

(k) As part of the annual internal review, an agency must test the response phase of its emergency preparedness and response plan in a planned drill if not tested during an actual emergency response. Except for a freestanding hospice inpatient unit, a planned drill can be limited to the agency's procedures for communicating with staff.

(l) An agency must make a good faith effort to comply with the requirements of this section during a disaster. If the agency is unable to comply with any of the requirements of this section, it must document in the agency's records attempts of staff to follow procedures outlined in the agency's emergency preparedness and response plan.

(m) An agency is not required to continue to provide care to clients in emergency situations that are beyond the agency's control and that make it impossible to provide services, such as when roads are impassable or when a client relocates to a place unknown to the agency. An agency may establish links to local emergency operations centers to determine a mechanism by which to approach specific areas within a disaster area in order for the agency to reach its clients.

(n) If written records are damaged during a disaster, the agency must not reproduce or recreate client records except from existing electronic records. Records reproduced from existing electronic records must include:

(1) the date the record was reproduced;

(2) the agency staff member who reproduced the record; and

(3) how the original record was damaged.

(o) Notwithstanding the provisions specified in Division 2 of this subchapter (relating to Conditions of a License), no later than five working days after an agency temporarily relocates a place of business, or temporarily expands its service area resulting from the effects of an emergency or disaster, an agency must notify and provide the following information to the DADS Home and Community Support Services Agencies licensing unit:

(1) if temporarily relocating a place of business:

(A) the license number for the place of business and the date of relocation;

(B) the physical address and phone number of the location; and

(C) the date the agency returns to a place of business after the relocation; or

(2) if temporarily expanding the service area to provide services during a disaster:

(A) the license number and revised boundaries of the service area;

(B) the date the expansion begins; and

(C) the date the expansion ends.

(p) An agency must provide the notice and information described in subsection (o) of this section by fax or email. If fax and email are unavailable, the agency may notify the DADS licensing unit by telephone, but must provide the notice and information in writing as soon as possible. If communication with the DADS licensing unit is not possible, the agency must provide the notice and information by fax, e-mail, or telephone to the designated survey office.

 

§97.257 Medicare Certification Optional

 

(a) An agency that applies for the category of licensed and certified home health services must comply with the regulations in the Medicare Conditions of Participation for Home Health Agencies, 42 CFR, Part 484, pending approval of certification granted by CMS. After DADS receives written approval from CMS, DADS amends the licensing status of the agency to include the licensed and certified home health services category.

(b) An agency providing hospice services and applying for participation in the Medicare program must comply with the Medicare Conditions of Participation for Hospice Care, 42 CFR Part 418, pending approval of certification granted by CMS. After DADS receives written approval from CMS, DADS enters the hospice provider number issued by CMS into its Home and Community Support Services Agencies database but does not amend the hospice services category on the license.

 

§97.259 Initial Educational Training in Administration of Agencies

 

(a) This section applies only to an administrator and alternate administrator designated as an administrator or alternate administrator for the first time on or after December 1, 2006.

(b) In addition to the qualifications and conditions described in §97.244 of this division (relating to Administrator Qualifications and Conditions and Supervising Nurse Qualifications), a first-time administrator and alternate administrator of an agency must each complete a total of 24 clock hours of educational training in the administration of an agency before the end of the first 12 months after designation to the position.

(c) Prior to designation, a first-time administrator or alternate administrator must complete eight clock hours of educational training in the administration of an agency. The initial eight clock hours must be completed during the 12 months immediately preceding the date of designation to the position. The initial eight clock hours must include:

(1) information on the licensing standards for an agency; and

(2) information on the state and federal laws applicable to an agency, including:

(A) the Texas Health and Safety Code, Chapter 142, Home and Community Support Services, and Chapter 250, Nurse Aide Registry and Criminal History Checks of Employees and Applicants for Employment in Certain Facilities Serving the Elderly or Persons with Disabilities;

(B) the Texas Human Resources Code, Chapter 102, Rights of the Elderly;

(C) the Americans with Disabilities Act;

(D) the Civil Rights Act of 1991;

(E) the Rehabilitation Act of 1993;

(F) the Family and Medical Leave Act of 1993; and

(G) the Occupational Safety and Health Administration requirements.

(d) A first-time administrator and alternate administrator must complete an additional 16 clock hours of educational training before the end of the first 12 months after designation to the position. Any of the additional 16 clock hours may be completed prior to designation if completed during the 12 months immediately preceding the date of designation to the position. The additional 16 clock hours must include the following subjects and may include other topics related to the duties of an administrator:

(1) information regarding fraud and abuse detection and prevention;

(2) legal issues regarding advance directives;

(3) client rights, including the right to confidentiality;

(4) agency responsibilities;

(5) complaint investigation and resolution;

(6) emergency preparedness planning and implementation;

(7) abuse, neglect, and exploitation;

(8) infection control;

(9) nutrition (for agencies licensed to provide inpatient hospice services); and

(10) the Outcome and Assessment Information Set (OASIS) (for agencies licensed to provide licensed and certified home health services).

(e) The 24-hour educational training requirement described in subsection (b) of this section must be met through structured, formalized classes, correspondence courses, competency-based computer courses, training videos, distance learning programs, or off-site training courses. Subject matter that deals with the internal affairs of an organization does not qualify for credit.

(1) The training must be provided or produced by:

(A) an academic institution;

(B) a recognized state or national organization or association;

(C) an independent contractor who consults with agencies; or

(D) an agency.

(2) If an agency or independent contractor provides or produces the training, the training must be approved by DADS or recognized by a state or national organization or association. The agency must maintain documentation of this approval or recognition for review by DADS surveyors.

(3) A first-time administrator and alternate administrator may apply joint training provided by DADS toward the 24 hours of educational training required by this section if the joint training meets the educational training requirements described in subsections (c) and (d) of this section.

(f) Documentation of administrator and alternate administrator training must:

(1) be on file at the agency; and

(2) contain the name of the class or workshop, the course content (such as the curriculum), the hours and dates of the training, and the name and contact information of the entity and trainer who provided the training.

(g) A first-time administrator and alternate administrator must not apply a pre-survey conference toward the 24 hours of educational training required in this section.

(h) After completing the 24 hours of initial educational training prior to or during the first 12 months after designation as a first-time administrator and alternate administrator, an administrator and alternate administrator must then complete the continuing education requirements as specified in §97.260 of this division (relating to Continuing Education in Administration of Agencies) in each subsequent 12-month period after designation.

 

§97.260 Continuing Education in Administration of Agencies

 

(a) In addition to the qualifications and conditions described in §97.244 of this division (relating to Administrator Qualifications and Conditions and Supervising Nurse Qualifications), an administrator and alternate administrator must complete 12 clock hours of continuing education within each 12-month period beginning with the date of designation. The 12 clock hours of continuing education must include at least two of the following topics and may include other topics related to the duties of an administrator:

(1) any one of the educational training subjects listed in §97.259(d) of this division (relating to Initial Educational Training in Administration of Agencies);

(2) development and interpretation of agency policies;

(3) basic principles of management in a licensed health-related setting;

(4) ethics;

(5) quality improvement;

(6) risk assessment and management;

(7) financial management;

(8) skills for working with clients, families, and other professional service providers;

(9) community resources; or

(10) marketing.

(b) This subsection applies only to an agency administrator or alternate administrator designated as an agency administrator or alternate administrator before December 1, 2006, who has not served as an administrator or alternate administrator for 180 days or more immediately preceding the date of designation. Within the first 12 months after the date of designation, at least eight of the 12 clock hours of continuing education must include the topics listed in §97.259(c) of this division. The remaining fours hours of continuing education must include topics related to the duties of an administrator and may include the topics listed in subsection (a) of this section.

(c) Documentation of administrator and alternate administrator continuing education must:

(1) be on file at the agency; and

(2) contain the name of the class or workshop, the topics covered, and the hours and dates of the training.

(d) An administrator or alternate administrator must not apply the pre-survey conference toward the continuing education requirements in this section.

 

Division 4, Provision and Coordination of Treatment and Services

§97.281 Client Care Policies

 

An agency must adopt and enforce a written policy that specifies the agency'sclient care practices. The written policy must include the following elements if covered under the scope of services provided by the agency:

(1) initial assessment, reassessment;

(2) start of care, placing services on hold, transfer, and discharge;

(3) intravenous services;

(4) care of the pediatric client;

(5) triaging clients in the event of disaster;

(6) how to handle emergencies in the home;

(7) safety of staff;

(8) procedures the staff will perform for clients, such as dressing changes, Foley catheter changes, wound irrigation, administration of medication;

(9) psychiatric nursing procedures;

(10) patient and caregiver teaching relating to disease process/procedures;

(11) care planning;

(12) care of the dying patient/client;

(13) receiving physician orders;

(14) performing waived testing;

(15) medication monitoring; and

(16) anything else pertaining to client care.

 

§97.282 Client Conduct and Responsibility and Client Rights

 

(a) An agency must adopt and enforce a written policy governing client conduct and responsibility and client rights in accordance with this section. The written policy must include a grievance mechanism under which a client can participate without fear of reprisal.

(b) An agency must protect and promote the rights of all clients.

(c) An agency must comply with the provisions of the Texas Human Resources Code, Chapter 102, Rights of the Elderly, which applies to a client 60 years of age or older.

(d) At the time of admission, an agency must provide a client who receives licensed home health services, licensed and certified home health services, hospice services, or personal assistance services with a written statement that informs the client that a complaint against the agency may be directed to the Department of Aging and Disability Services, DADS' Consumer Rights and Services Division, P.O. Box 149030, Austin, Texas 78714-9030, toll free 1-800-458-9858. The statement also may inform the client that a complaint against the agency may be directed to the administrator of the agency. The statement about complaints directed to the administrator also must include the time frame in which the agency will review and resolve the complaint.

(e) In advance of furnishing care to a client or during the initial evaluation visit before the initiation of treatment, an agency must provide the client or their legal representative with a written notice of all policies governing client conduct and responsibility and client rights.

(f) A client has the following rights:

(1) A client has the right to be informed in advance about the care to be furnished, the plan of care, expected outcomes, barriers to treatment, and any changes in the care to be furnished. The agency must ensure that written informed consent specifying the type of care and services that may be provided by the agency has been obtained for every client, either from the client or their legal representative. The client or the legal representative must sign or mark the consent form.

(2) A client has the right to participate in planning the care or treatment and in planning a change in the care or treatment.

(A) An agency must advise or consult with the client or legal representative in advance of any change in the care or treatment.

(B) A client has the right to refuse care and services.

(C) A client has the right to be informed, before care is initiated, of the extent to which payment may be expected from the client, a third-party payer, and any other source of funding known to the agency.

(3) A client has the right to have assistance in understanding and exercising the client's rights. The agency must maintain documentation showing that it has complied with the requirements of this paragraph and that the client demonstrates understanding of the client's rights.

(4) A client has the right to exercise rights as a client of the agency.

(5) A client has the right to have the client's person and property treated with consideration, respect, and full recognition of the client's individuality and personal needs.

(6) A client has the right to be free from abuse, neglect, and exploitation by an agency employee, volunteer, or contractor.

(7) A client has the right to confidential treatment of the client's personal and medical records.

(8) A client has the right to voice grievances regarding treatment or care that is or fails to be furnished, or regarding the lack of respect for property by anyone who is furnishing services on behalf of the agency and must not be subjected to discrimination or reprisal for doing so.

(g) In the case of a client adjudged incompetent, the rights of the client are exercised by the person appointed by law to act on the client's behalf.

(h) In the case of a client who has not been adjudged incompetent, any legal representative may exercise the client's rights to the extent permitted by law.

 

§97.283 Advance Directives

 

(a) An agency must maintain a written policy regarding implementation of advance directives. The policy must be in compliance with the Advance Directives Act, Health and Safety Code, Chapter 166. The policy must include a clear and precise statement of any procedure the agency is unwilling or unable to provide or withhold in accordance with an advance directive.

(b) The agency must provide written notice to a client of the written policy required by subsection (a) of this section. The notice must be provided at the earlier of:

(1) the time the client is admitted to receive services from the agency; or

(2) the time the agency begins providing care to the client.

(c) If, at the time notice must be provided under subsection (b) of this section, the client is incompetent or otherwise incapacitated and unable to receive the notice, the agency must provide the required written notice, in the following order of preference, to:

(1) the client's legal guardian;

(2) a person responsible for the health care decisions of the client;

(3) the client's spouse;

(4) the client's adult child;

(5) the client's parent; or

(6) the person admitting the client.

(d) If subsection (c) of this section applies, except as provided by subsection (e) of this section, if an agency is unable, after a diligent search, to locate an individual listed by subsection (c) of this section, the agency is not required to provide the notice.

(e) If a client who was incompetent or otherwise incapacitated and unable to receive the notice required by this section at the time notice was to be provided under subsection (b) of this section later becomes able to receive the notice, the agency must provide the written notice at the time the client becomes able to receive the notice.

(f) DADS assesses an administrative penalty of $500 without an opportunity to correct against an agency that violates this section.

 

§97.284 Laboratory Services

 

An agency that provides laboratory services must adopt and enforce a written policy to ensure that the agency meets the Clinical Laboratory Improvement Act, 42 United States Code Annotated, §263a, (CLIA 1988). CLIA 1988 applies to all agencies 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.

 

§97.285 Infection Control

 

An agency must adopt and enforce written policies addressing infection control including the prevention of the spread of infectious and communicable disease. The policies must:

(1) ensure compliance by the agency, its employees, and its contractors with:

(A) the Communicable Disease Prevention and Control Act, Health and Safety Code, Chapter 81;

(B) the Occupational Safety and Health Administration (OSHA), 29 CFR Part 1910.1030 and Appendix A relating to Bloodborne Pathogens; and

(C) the Health and Safety Code, Chapter 85, Subchapter I, concerning the prevention of the transmission of human immunodeficiency virus and hepatitis B virus; and

(2) require documentation of infections that the client acquires while receiving services from the agency.

(A) If an agency is licensed to provide only personal assistance services, documentation must include the date that the infection was disclosed to the agency employee, the client's name, and treatment.

(B) If an agency is licensed to provide services other than personal assistance services, documentation must include the date that the infection was detected, the client's name, primary diagnosis, signs and symptoms, type of infection, pathogens identified, and treatment as disclosed by the client.

 

§97.286 Disposal of Special or Medical Waste

 

(a) An agency must adopt and enforce a written policy for the safe handling and disposal of biohazardous waste and materials, if applicable.

(b) An agency that generates special or medical waste while providing home health services must dispose of the waste according to the requirements in 25 TAC, §§1.131-1.137 (relating to Definition, Treatment, and Disposition of Special Waste from Health Care-Related Facilities). An agency must provide both verbal and written instructions to the agency's clients regarding the proper procedure for disposing of sharps. For purposes of this subsection, sharps include hypodermic needles, hypodermic syringes with attached needles, scalpel blades, razor blades, disposable razors, disposable scissors used in medical procedures, and intravenous stylets and rigid introducers.

 

§97.287 Quality Assessment and Performance Improvement

 

(a) Quality Assessment and Performance Improvement (QAPI) Program.

(1) An agency must maintain a QAPI Program that is implemented by a QAPI Committee. The QAPI Program must be ongoing, focused on client outcomes that are measurable, and have a written plan of implementation. The QAPI Committee must review and update or revise the plan of implementation at least once within a calendar year, or more often if needed. The QAPI Program must include:

(A) a system that measures significant outcomes for optimal care. The QAPI Committee must use the measures in the care planning and coordination of services and events. The measures must include the following as appropriate for the scope of services provided by the agency:

(i) an analysis of a representative sample of services furnished to clients contained in both active and closed records;

(ii) a review of:

(I) negative client care outcomes;

(II) complaints and incidents of unprofessional conduct by licensed staff and misconduct by unlicensed staff;

(III) infection control activities;

(IV) medication administration and errors; and

(V) effectiveness and safety of all services provided, including:

(-a-) the competency of the agency's clinical staff;

(-b-) the promptness of service delivery; and

(-c-) the appropriateness of the agency's responses to client complaints and incidents;

(iii) a determination that services have been performed as outlined in the individualized service plan, care plan, or plan of care; and

(iv) an analysis of client complaint and satisfaction survey data; and

(B) an annual evaluation of the total operation, including services provided under contract or arrangement.

(i) An agency must use the evaluation to correct identified problems and, if necessary, to revise policies.

(ii) An agency must document corrective action to ensure that improvements are sustained over time.

(2) An agency must immediately correct identified problems that directly or potentially threaten the client care and safety.

(3) QAPI documents must be kept confidential and be made available to DADS staff upon request.

(b) QAPI Committee membership. At a minimum, the QAPI Committee must consist of:

(1) the administrator;

(2) the supervising nurse or therapist, or the supervisor of an agency licensed to provide personal assistance services; and

(3) an individual representing the scope of services provided by the agency.

(c) Frequency of QAPI Committee meeting. The QAPI Committee must meet twice a year or more often if needed.

 

§97.288 Coordination of Services

 

(a) An agency must adopt and enforce a written policy regarding coordination of services to ensure the effective exchange of information, reporting, and coordination of client services among:

(1) all agency personnel providing care and services, whether the care and services are provided directly or under arrangement;

(2) the agency and other providers of health care services involved in the care of a client, if known by the agency; and

(3) the agency and a licensed facility, group home, foster home, or boarding home facility in which a client resides.

(b) The agency must include documentation in the client record of coordination of services as specified in subsection (a) of this section.

(c) In this section, other providers of health care services involved in the care of a client may include:

(1) a physician;

(2) another agency;

(3) an adult day care center;

(4) an outpatient facility; and

(5) a managed care organization.

 

§97.289 Independent Contractors and Arranged Services

 

(a) Independent contractors. If an agency uses independent contractors, there must be a contract between each independent contractor that performs services and the agency. The contract must be enforced by the agency and clearly designate:

(1) that clients are accepted for care only by the agency;

(2) the services to be provided by the contractor and how they will be provided (i.e. per visit, per hours, etc.);

(3) the necessity of the contractor to conform to all applicable agency policies, including personnel qualifications;

(4) the contractor's responsibility for participating in developing the plan of care, care plan or individualized service plan;

(5) the manner in which services will be coordinated and evaluated by the agency in accordance with §97.288 of this subchapter (relating to Coordination of Services);

(6) the procedures for:

(A) submitting information and documentation by the contractor in accordance with the agency's client record policies;

(B) scheduling of visits by the contractor or the agency;

(C) periodic client evaluation by the contractor; and

(D) determining charges and reimbursement payable by the agency for the contractor's services under the contract.

(b) Arranged services. Home health services, hospice services, or personal assistance services provided by an agency under arrangement with another agency or organization must be provided under a written contract conforming to the requirements specified in subsection (a) of this section.

(c) If an agency contracts with another agency or organization for an unlicensed person to provide home health services, hospice services, or personal assistance services under arrangement, the agency must ensure that either it or the contracting agency or organization:

(1) searches the nurse aide registry (NAR) and the employee misconduct registry (EMR) before the unlicensed person's first face-to-face contact with a client of the agency using the DADS Internet website to confirm that the unlicensed person is not listed in either registry as unemployable;

(2) provides written information to the unlicensed person about the EMR that complies with the requirements of §93.3(c) of this title (relating to Employment and Registry Information); and

(3) searches the NAR and the EMR at least every twelve months using the DADS Internet website to confirm that the person is not listed in either registry as unemployable.

(d) If an agency contracts with another agency or organization for an unlicensed person to provide home health services, hospice services, or personal assistance services under arrangement, the agency must ensure that the contracting agency or organization:

(1) conducts a criminal history check before the unlicensed person's first face-to-face contact with a client of the agency; and

(2) verifies that the unlicensed person's criminal history information does not include a conviction that bars employment under the Texas Health and Safety Code §250.006.

(e) Documentation for contract staff. An agency is not required to maintain a personnel record for independent contractors or staff who provide services under arrangement with another agency or organization. Upon request by DADS, an agency must provide documentation at the site of a survey within eight working hours of the request to demonstrate:

(1) that independent contractors or staff under arrangement meet the agency's written job qualifications for the position and duties performed;

(2) the agency ensures compliance with subsection (c) of this section for unlicensed staff providing services to the agency’s clients under arrangement; and

(3) the agency complies with subsection (d) of this section for unlicensed staff providing services to the agency's clients under arrangement by providing a written statement, signed by a person authorized to make decisions on personnel matters for the contracting agency or organization, attesting that a criminal history check was conducted before an unlicensed person's first face-to-face contact with a client and did not include a conviction barring employment under THSC §250.006.

 

§97.290 Backup Services and After Hours Care

 

(a) Backup services. An agency must adopt and enforce a written policy to ensure that backup services are available when an agency employee or contractor is not available to deliver the services.

(1) Backup services may be provided by an agency employee, a contractor, or the client's designee who is willing and able to provide the necessary services.

(2) If the client's designee has agreed to provide backup services required by this section, the agency must have the designee sign a written agreement to be the backup service provider. The agency must keep the agreement in the client's file.

(3) An agency must not coerce a client to accept backup services.

(b) After hours care. An agency must adopt and enforce a written policy to ensure that clients are educated in how to access care from the agency or another health care provider after regular business hours.

 

§97.291 Agency Dissolution

 

An agency must adopt and enforce a written policy that describes the agency'swritten contingency plan.

(1) The plan must be implemented in the event of dissolution to assure continuity of client care.

(2) The plan must:

(A) be consistent with §97.295 of this title (relating to Client Transfer or Discharge Notification Requirements);

(B) include procedures for:

(i) notifying the client of the agency's dissolution;

(ii) documenting the notification;

(iii) carrying out the notification; and

(C) comply with §97.217(a)(2) of this chapter (relating to Agency Closure Procedures and Voluntary Suspension of Operations).

 

§97.292 Agency and Client Agreement and Disclosure

 

(a) The agency must provide the client or the client's family with a written agreement for services. The agency must comply with the terms of the agreement. The agreement must include at a minimum the following:

(1) notification of client rights;

(2) documentation concerning notification to the client of the availability of medical power of attorney for health care, advance directive or "Do Not Resuscitate" orders in accordance with the applicable law;

(3) services to be provided;

(4) supervision by the agency of services provided;

(5) agency charges for services rendered if the charges will be paid in full or in part by the client or the client's family, or on request;

(6) a written statement containing procedures for filing a complaint in accordance with §97.282(d) of this chapter (relating to Client Conduct and Responsibility and Client Rights); and

(7) a client agreement to and acknowledgement of services by home health medication aides, if home health medication aides are used.

(b) The agency must obtain an acknowledgment of receipt from the client or his family of the items listed under subsection (a) of this section. This acknowledgment of receipt must be kept in the client's record.

 

§97.293 Client List and Services

 

An agency must maintain a current list of clients for each category of service licensed.

(1) The list must include all services being delivered by the agency and services being delivered under contract.

(2) The client list must include the client's name, identification or clinical record number, start of care date or admission date, certification period (if applicable), diagnosis(es) or functional assessment (as appropriate), and the disciplines that are providing services.

 

§97.294 Time Frame(s) for the Initiation of Care or Services

 

An agency must adopt and enforce a written policy establishing time frame(s) for the initiation of care or services.

 

§97.295 Client Transfer or Discharge Notification Requirements

 

(a) Except as provided in subsection (e) of this section, an agency intending to transfer or discharge a client must:

(1) provide written notification to the client or the client's parent, family, spouse, significant other or legal representative; and

(2) notify the client's attending physician or practitioner if he is involved in the agency's care of the client.

(b) An agency must ensure delivery of the written notification no later than five days before the date on which the client will be transferred or discharged.

(c) The agency must deliver the required notice by hand or by mail.

(d) If the agency delivers the written notice by mail:

(1) the notice must be mailed at least eight working days before the date of discharge or transfer; and

(2) the agency must speak with the client by telephone or in person to ensure the client's knowledge of the transfer or discharge at least five days before the date of discharge or transfer.

(e) An agency may transfer or discharge a client without prior notice required by subsection (b) of this section:

(1) upon the client's request;

(2) if the client's medical needs require transfer, such as a medical emergency;

(3) in the event of a disaster when the client's health and safety is at risk in accordance with provisions of §97.256 of this chapter (relating to Emergency Preparedness Planning and Implementation);

(4) for the protection of staff or a client after the agency has made a documented reasonable effort to notify the client, the client's family and physician, and appropriate state or local authorities of the agency's concerns for staff or client safety, and in accordance with agency policy;

(5) according to physician orders; or

(6) if the client fails to pay for services, except as prohibited by federal law.

(f) An agency must keep the following in the client's file:

(1) a copy of the written notification provided to the client or the client's parent, family, spouse, significant other or legal representative;

(2) documentation of the personal contact with the client if the required notice was delivered by mail; and

(3) documentation that the client's attending physician or practitioner was notified of the date of discharge.

 

§97.296 Physician Delegation and Performance of Physician-Delegated Tasks

 

(a) An agency must adopt and enforce a written policy that states whether or not physician delegation will be honored by the agency. If an agency accepts physician delegation, the agency must comply with the Medical Practice Act, Occupations Code, Chapter 157, concerning physician delegation.

(b) An agency may accept delegation from a physician only if the agency receives the following from the physician:

(1) the name of the client;

(2) the name of the delegating physician;

(3) the task(s) to be performed;

(4) the name of the individual(s) to perform the task(s);

(5) the time frame for the delegation order; and

(6) if the task is medication administration, the medication to be given, route, dose and frequency.

 

§97.297 Receipt of Physician Orders

 

An agency must adopt and enforce a written policy describing protocols and procedures agency staff must follow when receiving physician orders.

(1) The policy must address the time frame for countersignature of physician verbal orders.

(2) Signed physician orders may be submitted via facsimile machine. The agency is not required to have the original signatures on file. However, the agency must be able to obtain original signatures if an issue surfaces that would require verification of an original signature. The policy must include protocols to follow when accepting physician orders via facsimile. If physician orders are accepted via facsimile, the policy must:

(A) outline safeguards to assure that transmitted information is sent to the appropriate individual; and

(B) outline the procedures to be followed in the case of misdirected transmission.

 

§97.298 Delegation of Nursing Tasks by Registered Professional Nurses to Unlicensed Personnel and Tasks Not Requiring Delegation

 

(a) An agency must adopt and enforce a written policy to ensure compliance with the following rules adopted by the Texas Board of Nursing:

(1) 22 TAC, Chapter 224 (relating to Delegation of Nursing Tasks by Registered Professional Nurses to Unlicensed Personnel for Clients with Acute Conditions or in Acute Care Environments); and

(2) 22 TAC, Chapter 225 (relating to RN Delegation to Unlicensed Personnel and Tasks Not Requiring Delegation in Independent Living Environments for Clients with Stable and Predictable Conditions).

(b) Requirements for RN delegation for personal assistance service clients are located in §97.404 of this chapter (relating to Standards Specific to Agencies Licensed to Provide Personal Assistance Services).

 

§97.299 Nursing Education, Licensure and Practice

 

If providing nursing services, an agency must adopt and enforce a written policy to ensure compliance with the rules of the Texas Board of Nursing adopted at 22 TAC Chapters 211-226 (relating to Nursing Continuing Education, Licensure, and Practice in the State of Texas).

 

§97.300 Medication Administration

 

(a) This section applies only to clients to whom agency staff administer medications.

(b) An agency must adopt and enforce a written policy for maintaining a current medication list and a current medication administration record.

(1) A client's practitioner must order administration of medication.

(2) An agency may incorporate a current medication list and medication administration record into one document.

(A) An agency must use the medication list to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies and contraindications.

(B) An agency must document in the medication administration record or clinical notes any medication that is not administered and the reason it was not administered.

(3) An individual delivering care must report any adverse reaction to a supervisor and document this in the client's record on the day of occurrence. If the adverse reaction occurs after regular business hours, the individual delivering care must report the adverse reaction as soon as it is disclosed.

 

§97.301 Client Records

 

(a) In accordance with accepted principles of practice, an agency must establish and maintain a client record system to ensure that the care and services provided to each client are completely and accurately documented, readily accessible and systematically organized to facilitate the compilation and retrieval of information.

(1) An agency must establish a record for each client and must maintain the record in accordance with and contain the information described in paragraph (9) of this subsection. An agency must keep a single file or separate files for each category of service provided to the client and the client's family. Hospice services provided to a client's family must be documented in the clinical record.

(2) The agency must adopt and enforce written procedures regarding the use and removal of records, the release of information, and when applicable, the incorporation of clinical, progress, or other notes into the client record. An agency may not release any portion of a client record to anyone other than the client except as allowed by law.

(3) All information regarding the client's care and services must be centralized in the client's record and be protected against loss or damage.

(4) The agency must establish an area for original active client record storage at the agency's place of business. The original active client record must be stored at the place of business (parent agency, branch office or alternate delivery site) from which services are actually provided. Original active client records must not be stored at an administrative support site or records storage facility.

(5) The agency must ensure that each client's record is treated with confidentiality, safeguarded against loss and unofficial use, and is maintained according to professional standards of practice.

(6) A clinical record must be an original, a microfilmed copy, an optical disc imaging system or a certified copy.

(A) An original record is a signed paper record or an electronically signed computer record. A signed paper record may include a physicians' stamped signature if the agency meets the following requirements:

(i) An agency must have on file at the agency a current written authorization letter from the physician whose signature the stamp represents, stating that he is the only person authorized to have the stamp and use it.

(ii) The authorization letter must be dated before a stamped record from the physician was accepted by the agency.

(iii) An agency must obtain a new authorization letter from the physician annually. A physician authorization letter is void one year from the date of the letter.

(iv) The authorization letter must be manually signed by the physician and include a copy of the stamped signature that the physician will use.

(B) Computerized records must meet all requirements of paper records including protection from unofficial use and retention for the period specified in subsection (b) of this section.

(C) An agency must ensure that entries regarding the delivery of care or services are not altered without evidence and explanation of such alteration.

(7) Each entry to the client record must be current, accurate, signed and dated with the date of entry by the individual making the entry. The record must include all services whether furnished directly or under arrangement. Correction fluid or tape must not be used in the record. Corrections must be made by striking through the error with a single line and must include the date the correction was made and the initials of the person making the correction.

(8) Inactive client records may be preserved on microfilm, optical disc or other electronic means and may be stored at the parent agency location, branch office, alternate delivery site, administrative support site or records storage facility. Security must be maintained and the record must be readily retrievable by the agency.

(9) Each client record must include the following elements as applicable to the scope of services provided by the agency:

(A) client application for services including, but not limited to: full name; sex; date of birth; name, address and telephone number of parent(s) of a minor child or legal guardian, or other(s) as identified by the individual; physician's name and telephone numbers, including emergency numbers; and services requested;

(B) initial health assessment, pertinent medical history and subsequent health assessments;

(C) care plan, plan of care, or individualized service plan, as applicable. The care plan or the plan of care must include, as applicable, medication, dietary, treatment, and activities orders. The requirements for the individualized service plan for personal assistance service clients are located in §97.404 of this chapter (relating to Standards Specific to Agencies Licensed to Provide Personal Assistance Services). The requirements for the plan of care for hospice clients are located in §97.403 of this chapter (relating to Standards Specific to Agencies Licensed to Provide Hospice Services);

(D) clinical and progress notes. Such notes must be written the day service is rendered and incorporated into the client record within 14 working days;

(E) current medication list;

(F) medication administration record (if medication is administered by agency staff). Notation must also be made in the medication administration record or in the clinical notes of medications not given and the reason. Any adverse reaction must be reported to a supervisor and documented in the client record;

(G) records of supervisory visits;

(H) complete documentation of all known services and significant events. Documentation must show that effective interchange, reporting, and coordination of care occurs as required in §97.288 of this chapter (relating to Coordination of Services);

(I) for clients 60 years and older, acknowledgment of the client's receipt of a copy of the Human Resources Code, Chapter 102, Rights of the Elderly;

(J) acknowledgment of the client's receipt of the agency's policy relating to the reporting of abuse, neglect or exploitation of a client;

(K) documentation that the client has been informed of how to register a complaint in accordance with §97.282(d) of this chapter (relating to Client Conduct and Responsibility and client Rights);

(L) client agreement to and acknowledgment of services by home health medication aides, if home health medication aides are used;

(M) discharge summary, including the reason for discharge or transfer and the agency's documented notice to the client, the client's physician (if applicable), and other individuals as required in §97.295 of this chapter (relating to Client Transfer or Discharge Notification Requirements);

(N) acknowledgement of receipt of the notice of advance directives;

(O) services provided to the client's family (as applicable); and

(P) consent and authorization and election forms, as applicable.

(b) An agency must adopt and enforce a written policy relating to the retention of records in accordance with this subsection.

(1) An agency must retain original client records for a minimum of five years after the discharge of the client.

(2) The agency may not destroy client records that relate to any matter that is involved in litigation if the agency knows the litigation has not been finally resolved.

(3) There must be an arrangement for the preservation of inactive records to insure compliance with this subsection.

 

§97.302 Pronouncement of Death

 

An agency must adopt and enforce a written policy on pronouncement of death if that function is carried out by an agency registered nurse. The policy must be in compliance with the Health and Safety Code, §671.001 (concerning Determination of Death and Autopsy Reports).

 

§97.303 Standards for Possession of Sterile Water or Saline, Certain Vaccines or Tuberculin, and Certain Dangerous Drugs

 

An agency that possesses sterile water or saline, certain vaccines or tuberculin, or certain dangerous drugs as specified by this section must comply with the provisions of this section.

(1) Possession of sterile water or saline. An agency or its employees who are registered nurses or licensed vocational nurses may purchase, store or transport for the purpose of administering to their home health or hospice clients under physician's orders:

(A) sterile water for injection and irrigation; and

(B) sterile saline for injection and irrigation.

(2) Possession of certain vaccines or tuberculin.

(A) An agency or its employees who are registered nurses or licensed vocational nurses may purchase, store or transport for the purpose of administering to the agency's employees, home health or hospice clients, or client family members under physician's standing orders the following dangerous drugs:

(i) hepatitis B vaccine;

(ii) influenza vaccine;

(iii) tuberculin purified protein derivative for tuberculosis testing; and

(iv) pneumococcal polysaccharide vaccine.

(B) An agency that purchases, stores or transports a vaccine or tuberculin under this section must ensure that any standing order for the vaccine or tuberculin:

(i) is signed and dated by the physician;

(ii) identifies the vaccine or tuberculin covered by the order;

(iii) indicates that the recipient of the vaccine or tuberculin has been assessed as an appropriate candidate to receive the vaccine or tuberculin and has been assessed for the absence of any contraindication;

(iv) indicates that appropriate procedures are established for responding to any negative reaction to the vaccine or tuberculin; and

(v) orders that a specific medication or category of medication be administered if the recipient has a negative reaction to the vaccine or tuberculin.

(3) Possession of certain dangerous drugs.

(A) In compliance with Health and Safety Code, §142.0063, an agency or its employees who are registered nurses or licensed vocational nurses may purchase, store, or transport for the purpose of administering to their home health or hospice patients, in accordance with subparagraph (C) of this paragraph, the following dangerous drugs:

(i) any of the following items in a sealed portable container of a size determined by the dispensing pharmacist:

(I) 1,000 milliliters of 0.9% sodium chloride intravenous infusion;

(II) 1,000 milliliters of 5.0% dextrose in water injection; or

(III) sterile saline; or

(ii) not more than five dosage units of any of the following items in an individually sealed, unused portable container:

(I) heparin sodium lock flush in a concentration of 10 units per milliliter or 100 units per milliliter;

(II) epinephrine HCI solution in a concentration of one to 1,000;

(III) diphenhydramine HCI solution in a concentration of 50 milligrams per milliliter;

(IV) methylprednisolone in a concentration of 125 milligrams per two milliliters;

(V) naloxone in a concentration of one milligram per milliliter in a two-milliliter vial;

(VI) promethazine in a concentration of 25 milligrams per milliliter;

(VII) glucagon in a concentration of one milligram per milliliter;

(VIII) furosemide in a concentration of 10 milligrams per milliliter;

(IX) lidocaine 2.5% and prilocaine 2.5% cream in a five-gram tube; or

(X) lidocaine HCL solution in a concentration of 1% in a two-milliliter vial.

(B) An agency or the agency's authorized employees may purchase, store, or transport dangerous drugs in a sealed portable container only if the agency has established policies and procedures to ensure that:

(i) the container is handled properly with respect to storage, transportation, and temperature stability;

(ii) a drug is removed from the container only on a physician's written or oral order;

(iii) the administration of any drug in the container is performed in accordance with a specific treatment protocol; and

(iv) the agency maintains a written record of the dates and times the container is in the possession of a registered nurse or licensed vocational nurse.

(C) An agency or the agency's authorized employee who administers a drug listed in subparagraph (A) of this paragraph may administer the drug only in the client's residence under physician's orders in connection with the provision of emergency treatment or the adjustment of:

(i) parenteral drug therapy; or

(ii) vaccine or tuberculin administration.

(D) If an agency or the agency's authorized employee administers a drug listed in subparagraph (A) of this paragraph pursuant to a physician's oral order, the agency must receive a signed copy of the order:

(i) not later than 24 hours after receipt of the order, reduce the order to written form and send a copy of the form to the dispensing pharmacy by mail or facsimile transmission; and

(ii) not later than 20 days after receipt of the order, send a copy of the order as signed by and received from the physician to the dispensing pharmacy.

(E) A pharmacist that dispenses a sealed portable container under this subsection will ensure that the container:

(i) is designed to allow access to the contents of the container only if a tamper-proof seal is broken;

(ii) bears a label that lists the drugs in the container and provides notice of the container's expiration date, which is the earlier of:

(I) the date that is six months after the date on which the container is dispensed; or

(II) the earliest expiration date of any drug in the container; and

(iii) remains in the pharmacy or under the control of a pharmacist, registered nurse, or licensed vocational nurse.

(F) If an agency or the agency's authorized employee purchases, stores, or transports a sealed portable container under this subsection, the agency must deliver the container to the dispensing pharmacy for verification of drug quality, quantity, integrity, and expiration dates not later than the earlier of:

(i) the seventh day after the date on which the seal on the container is broken; or

(ii) the date for which notice is provided on the container label.

(G) A pharmacy that dispenses a sealed portable container under this section is required to take reasonable precautionary measures to ensure that the agency receiving the container complies with subparagraph (F) of this paragraph. On receipt of a container under subparagraph (F) of this paragraph, the pharmacy will perform an inventory of the drugs used from the container and will restock and reseal the container before delivering the container to the agency for reuse.

 

Division 5, Branch Offices and Alternate Delivery Sites

§97.321 Standards for Branch Offices

 

(a) A branch office operates as a part of the parent agency and must comply with the same regulations as the parent agency. The parent agency is responsible for ensuring that its branches comply with licensing standards.

(b) A branch office providing licensed and certified home health services must comply with the standards for certified agencies in §97.402 of this chapter (relating to Standards Specific to Licensed and Certified Home Health Services).

(c) The service area of a branch office must be located within the parent agency's service area.

(1) A branch office must not provide services outside its licensed service area.

(2) A branch office must maintain adequate staff to provide services and to supervise the provision of services within the service area.

(3) A branch office may expand its service area at any time during the licensure period.

(A) Unless exempted under subparagraph (B) of the paragraph, a branch office must submit to DADS a written notice to expand its service area at least 30 days before the expansion. The notice must include:

(i) revised boundaries of the branch office's original service area;

(ii) the effective date of the expansion; and

(iii) an updated list of management and supervisory personnel (including names), if changes are made.

(B) An agency is exempt from the 30-day written notice requirement under subparagraph (A) of this paragraph if DADS determines an emergency exists that would impact client health and safety. An agency must notify DADS immediately of a possible emergency. DADS determines if an exemption can be granted.

(4) A branch office may reduce its service area at any time during the licensure period by sending DADS written notification of the reduction, revised boundaries of the branch office's original service area, and the effective date of the reduction.

(d) A parent agency and a branch office providing home health or personal assistance services must meet the following requirements:

(1) The parent agency administrator or alternate administrator, or supervising nurse or alternate supervising nurse must conduct an on-site supervisory visit to the branch office at least monthly. The parent agency may visit the branch office more frequently considering the size of the service area and the scope of services provided by the parent agency. The supervisory visits must be documented and include the date of the visit, the content of the consultation, the individuals in attendance, and the recommendations of the staff.

(2) The original active clinical record must be kept at the branch office.

(3) The parent agency must approve all branch office policies and procedures. This approval must be documented and filed in the parent and branch offices.

(e) DADS issues or renews a branch office license for applicants who meet the requirements of this section.

(1) Issuance or renewal of a branch office license is contingent upon compliance with the statute and this chapter by the parent agency and branch office.

(2) DADS may take enforcement action against a parent agency license for a branch office's failure to comply with the statute or this chapter in accordance with Subchapter F of this chapter (relating to Enforcement).

(3) Revocation, suspension, denial, or surrender of a parent agency license will result in the same revocation, suspension, denial, or surrender of a branch office license for all branch office licenses of the parent agency.

(f) A branch office may offer fewer health services or categories than the parent office but may not offer health services or categories that are not also offered by the parent agency.

 

§97.322 Standards for Alternate Delivery Sites

 

(a) An alternate delivery site (ADS) must comply with the statute and this chapter, including the additional standards in Subchapter H of this chapter (relating to Standards Specific to Agencies Licensed to Provide Hospice Services).

(b) If certified by CMS, an ADS must comply with the applicable federal rules and regulations for hospice agencies in 42 CFR, Part 418, Hospice Care.

(c) A parent agency and an ADS must meet the following requirements:

(1) The parent agency administrator or alternate administrator, or supervising nurse or alternate supervising nurse must conduct an on-site supervisory visit to the ADS at least monthly. The parent agency may visit the ADS more frequently considering the size of the service area provided by the parent agency. The supervisory visits must be documented and include the date of the visit, the content of the consultation, the individuals in attendance, and the recommendations of the staff.

(2) The parent agency must approve all ADS policies and procedures. This approval must be documented and filed in the parent agency and ADS.

(d) Issuance or renewal of an ADS license is contingent upon compliance by the parent agency and ADS with the statute and this chapter.

(1) DADS may take enforcement action against a parent agency license for an ADS' failure to comply with the statute or this chapter in accordance with Subchapter F of this chapter (relating to Enforcement).

(2) Revocation, suspension, denial or surrender of a parent agency license results in the same revocation, suspension, denial or surrender of all ADS licenses of the parent agency.