2514 stenson dr | cedar park tx 78613 | 512-336-1005 | fax...

2514 Stenson Dr | Cedar Park TX 78613 | 512-336-1005 | Fax 512-336-1008 | [email protected]

HCSSA OVERVIEW | © 2012 | of 32

HCSSA OVERVIEW This training is designed to provide an introduction to most HCSSA regulations and laws, but regulations and laws will not be covered in their entirety. Because unlike a nursing home or assisted living facility where patients come to you, you are entering a patient’s home therefore you must be held to a higher standard. There is a greater level of trust involved. It remains the full responsibility of each agency to remain in compliance with applicable federal, state, and local regulations and/or laws governing HCSSAs and the services they provide. Agencies must be able to demonstrate compliance with applicable regulations and/or laws during the initial HCSSA survey and during any subsequent visits.

Both DADS and the Centers for Medicare and Medicaid Services (CMS) communicate routinely with providers to deliver current information on how to interpret and apply regulations. It is your responsibility to acquire the most current HCSSA information available.

To access current DADS communications, visit the DADS Provider Communications Website http://www.dads.state.tx.us/providers/communications/index.cfm

To receive free electronic notification of changes to the DADS website including the publication of new provider communications, setup your subscription at https://public.govdelivery.com/accounts/TXHHSC/subscriber/new?qsp=307

MODULE I ~ INTRODUCTION In this module we will review: • HCSSA Service Categories • Licensure, Certification, and Contracts • The Licensure Steps

HCSSA Service Categories Personal Assistance Services (PAS) §97.2(72) PAS is defined as ‘routine ongoing care or services required by an individual in a residence or independent living environment that enable the individual to engage in the activities of daily living or to perform the physical functions required for independent living, including respite services’.

Services allowable under the PAS category include the following: • personal care tasks, including bathing, dressing, grooming, feeding, exercising, toileting,

positioning, assisting with self-administered medications, routine hair and skin care, and transfer or ambulation

• health-related services performed under circumstances that are defined as not constituting the practice of professional nursing by the Board of Nursing (BON) through a memorandum of understanding with DADS in accordance with Health and Safety Code, §142.016

• health-related tasks provided by unlicensed personnel under the delegation of a registered nurse or that a registered nurse determines do not require delegation

Agencies offering PAS must maintain compliance with the following state regulations: • Health and Safety Code, Chapter 142 • Title 40 Texas Administrative Code, Chapter 97 ** • Title 40 Texas Administrative Code, Chapter 99 • Title 22 Texas Administrative Code, Part 11, Chapter 225

** PAS agencies must follow all sections of Subchapters A, B, C, E, F, G and the PAS-specific rule section in Subchapter D §97.404.

Agencies with only the PAS category may not receive reimbursements through Medicare, but some PAS agencies may qualify for certain Medicaid contracts.



Medicaid contracts that may be sought under the PAS service category include the following: • CLASS ~ Community Living Assistance and Support Services (non-skilled) • CMPAS ~ Consumer Managed Personal Assistance Services (non-skilled) • DBMD ~ Deaf and Blind with Multiple Disabilities (non-skilled) • FC ~ Family Care • PHC ~ Primary Home Care • SSPD ~ Special Services to Persons with Disabilities 24-Hour • Attendant Care (non-skilled) • In Home Respite (non-skilled)

Licensed Home Health Services (LHHS) §97.2(45) LHHS is defined as ‘the provision of one or more of the following health services required by an individual in a residence or independent living environment: • nursing including blood pressure monitoring and diabetes treatment; • physical, occupational, speech, or respiratory therapy; • medical social service; • intravenous therapy; • dialysis; • service provided by unlicensed personnel under the delegation or supervision of a licensed

health professional; • the furnishing of medical equipment and supplies, excluding drugs and medicines; or • nutritional counseling.

Agencies offering LHHS must remain in compliance with the following state regulations: • Health and Safety Code, Chapter 142 • Title 40 Texas Administrative Code, Chapter 97 ** • Title 40 Texas Administrative Code, Chapter 99 • Title 22 Texas Administrative Code, Part 11, Chapter 224 • Title 22 Texas Administrative Code, Part 11, Chapter 225

** LHHS agencies must follow all sections of Subchapters A, B, C, E, F, G and the LHHS-specific rule section in Subchapter D §97.401.

Agencies with only the LHHS category may not receive reimbursements through Medicare, but LHHS agencies may qualify for certain Medicaid contracts.

Medicaid contracts that may be sought under the LHHS service category include the following: • CBA ~ Community-Based Alternatives (skilled) • CLASS ~ Community Living Assistance and Support Services (skilled) • CWP ~ Consolidated Waiver Program (skilled) • DBMD ~ Deaf and Blind with Multiple Disabilities (skilled) • PACE ~ Program of All-Inclusive Care for the Elderly (skilled, private pay skilled)

Under the LHHS category, agencies may also provide services for any of the waiver programs available to the PAS category.

Licensed Home Health Services with Dialysis (LHHS-D) §97.2(45) Agencies with the LHHS service category that plan to provide peritoneal dialysis or hemodialysis in clients’ residences or independent living environments must designate the Home Dialysis Services option (LHHS-D) in their application.



Agencies offering LHHS-D must remain in compliance with the following state regulations: • Health and Safety Code, Chapter 142 • Title 40 Texas Administrative Code, Chapter 97 ** • Title 40 Texas Administrative Code, Chapter 99 • Title 22 Texas Administrative Code, Part 11, Chapter 224 • Title 22 Texas Administrative Code, Part 11, Chapter 225

** LHHS-D agencies must follow all sections of Subchapters A, B, C, E, F, G and the LHHS-specific rule section in Subchapter D §97.401(excluding §97.401(b)(2)(A) and (B)) and the dialysis-specific rules found at §97.405. If there is a conflict between §97.401 and §97.405, standards specified in the dialysis section §97.405 should be followed.

Agencies with only the LHHS-D category may not receive reimbursements through Medicare, but LHHS-D agencies may qualify for certain Medicaid contracts.

Medicaid contracts that may be sought under the LHHS-D service category include the following: • CBA ~ Community-Based Alternatives (skilled) • CLASS ~ Community Living Assistance and Support Services (skilled) • CWP ~ Consolidated Waiver Program (skilled) • DBMD ~ Deaf and Blind with Multiple Disabilities (skilled) • PACE ~ Program of All-Inclusive Care for the Elderly (skilled, private pay skilled)

Under the LHHS-D category, agencies may also provide services for any of the waiver programs available to the PAS category.

Licensed & Certified Home Health Services (LCHHS) §97.402(a); 42 CFR §484.14(a) Agencies that select the LCHHS category of service may apply to receive Medicare contracts and must therefore be certified as in compliance with the federal Medicare Conditions of Participation, in addition to being in compliance with state licensing standards. Medicare clients of LCHHS agencies must meet the federal criteria for homebound status and must require skilled care.

Federal regulations state that home health services provided include part-time or intermittent skilled nursing services and at least one other therapeutic service such as physical, speech, or occupational therapy; medical social services; or home health aide services. These services are made available on a visiting basis, in a place of residence used as a patient’s home.

Agencies offering LCHHS must remain in compliance with the following state regulations and federal laws: • Health and Safety Code, Chapter 142 • Title 40 Texas Administrative Code, Chapter 97 ** • Title 40 Texas Administrative Code, Chapter 99 • Title 22 Texas Administrative Code, Part 11, Chapter 224 • Title 22 Texas Administrative Code, Part 11, Chapter 225 • 42 Code of Federal Regulations Part 484 • Social Security Act ~ Title XVIII for Medicare, Title XIX for Medicaid

** LCHHS agencies must follow all sections of Subchapters A, B, C, E, F, G and the LCHHS-specific rule section in Subchapter D §97.402.

Agencies providing Home Dialysis Services must select either the LHHS or LCHHS service category, and follow dialysis-specific rules in Subchapter D §97.405.

Agencies with the LCHHS category qualify for both Medicare and Medicaid contracts.

Medicaid contracts that may be sought under the LCHHS service category include the following: • Medicare or Medicaid (fee-for-service) • CCP ~ Comprehensive Care Program (contracts requiring LCHHS category designation)



Under the LCHHS category, agencies may also provide services for any of the waiver programs available to the PAS or LHHS categories.

Licensed & Certified Home Health Services with Dialysis (LCHHS-D) §97.402(a); 42 CFR §484.14(a) Agencies that select the LCHHS-D category may receive Medicare reimbursement for services they provide.

In addition to the services offered by LCHHS agencies, agencies selecting the LCHHS-D category designation may offer peritoneal dialysis or hemodialysis in clients’ residences or independent living environments.

Agencies offering LCHHS-D must remain in compliance with the following state regulations and federal laws: • Health and Safety Code, Chapter 142 • Title 40 Texas Administrative Code, Chapter 97 ** • Title 40 Texas Administrative Code, Chapter 99 • Title 22 Texas Administrative Code, Part 11, Chapter 224 • Title 22 Texas Administrative Code, Part 11, Chapter 225 • 42 Code of Federal Regulations Part 484 • Social Security Act ~ Title XVIII for Medicare, Title XIX for Medicaid

** LCHHS-D agencies must follow all sections of Subchapters A, B, C, E, F, G and the LCHHS-specific rule section in Subchapter D §97.402 and the dialysis-specific rules found at §97.405. If there is a conflict between these standards, the standards specified in the dialysis section §97.405 should be followed.

Agencies with the LCHHS-D category qualify for both Medicare and Medicaid contracts.

Medicaid contracts that may be sought under the LCHHS-D service category include the following: • Medicare or Medicaid (fee-for-service) • CCP ~ Comprehensive Care Program (contracts requiring LCHHS-D category designation)

Under the LCHHS-D category, agencies may also provide services for any of the waiver programs available to the PAS or LHHS categories.

Hospice Services §97.2(47) Hospice services include those services provided to a client or a client’s family as part of a coordinated program focused on providing palliative care for terminally ill clients and support services for clients and their families.

Hospice services are available 24 hours a day, seven days a week, during the last stages of illness, during death, and during bereavement.

Hospice services are provided by a medically directed, interdisciplinary team.

Agencies offering Hospice Services must remain in compliance with the following state regulations and federal laws. • Health and Safety Code, Chapter 142 • Title 40 Texas Administrative Code, Chapter 97 ** • Title 40 Texas Administrative Code, Chapter 99 • Title 22 Texas Administrative Code, Part 11, Chapter 224 • Title 22 Texas Administrative Code, Part 11, Chapter 225 • 42 Code of Federal Regulations Part 418 • Social Security Act ~ Title XVIII for Medicare, Title XIX for Medicaid

** Hospice agencies must follow all sections of Subchapters A, B, C, E, F, G and the Hospice-specific rule section in Subchapter D §97.403.



Licensure, Certification, and Contracts Licensure §97.3; §97.19; §97.31; §97.521; §97.601 Licensure is mandatory. All HCSSAs must be licensed in order to legally operate in Texas.

To become licensed, agencies must: • Successfully complete the Presurvey computer based training. • Properly complete a license application. • Pay the required license fee.

You may request a licensure application packet and download all of the required application forms from DADS provider website. http://www.dads.state.tx.us/providers/HCSSA/howto.html

After an agency receives its initial license, it must admit at least one client and initiate services within six months, and submit a written request for an initial survey to the designated regional survey office at least six months after the effective date of the initial license. DADS may propose to revoke or suspend the initial license for failure to request an initial survey.

For an agency’s license to be renewed, the agency must be surveyed as satisfactory. The results of all inspections, surveys, follow-up visits, or complaint/incident investigations must show agencies to be in compliance with all current applicable state licensure and federal certification laws and rules.

To ensure compliance with all applicable laws and rules, DADS regularly surveys all licensed HCSSAs. After the initial survey, agencies are re-surveyed within 18 and then at least every 36 months thereafter. DADS also conducts surveys to investigate complaints.

License Fees §97.3; §97.25(a); §97.31 The schedule of fees for licensure of an agency authorized to provide one or more services is as follows: • Initial or change of ownership license: $1,750 • Renewal license: $1,750 • Initial or change of ownership branch office license: $1,750 • Renewal branch office license: $1,750 • Initial or change of ownership alternate delivery site license: $1,000 • Renewal alternate delivery site license: $600

An agency must resubmit the initial license application and initial license application fee if it undergoes a change of ownership. If this application is not received in a timely manner, the agency must additionally pay a late fee of $250.

Correct application fees must accompany all license applications. Applications will not be officially accepted until applicants pay all necessary license application fees.

DADS will accept the following as payment for application fees: certified checks, money orders, or personal checks made out to DADS.

Application fees are non-refundable, but requests for refunds may be made under certain circumstances. If DADS does not process an application within the time frames established in the regulations, the applicant may request that DADS reimburse the license fee. If DADS does not agree that the established time frames have been violated, or finds that good cause existed for exceeding the established time frames, DADS will deny the reimbursement request. Delays caused by a significant increase in applications or by another entity may be considered to be good cause.



Certification Certification is optional. HCSSAs may choose to seek certification for participation in Medicare. Medicare is health insurance coverage provided through the CMS and the Social Security Administration (SSA). The SSA determines whether an individual is eligible for Medicare. In general, Medicare is provided to: • People age 65 and older • Certain disabled people under age 65 • People of any age who have permanent kidney failure

If an agency seeking certification is found to be in substantial compliance with both state and federal regulations during the initial certification survey, DADS recommends to CMS that the agency be certified. Agencies can receive payment from CMS only after they have obtained Medicare certification from CMS.

Contracts Participation in Medicare-waiver contract programs is optional. Licensed and certified HCSSAs may seek to participate in Medicaid-waiver contract programs. • The waiver programs are administered by DADS Provider Services and/or the Health and

Human Services Commission (HHSC). Contract managers conduct on-site reviews to evaluate the agency’s compliance with contract requirements.

• A waiver program is a Medicaid program that provides home and community-based services to a limited number of eligible clients, usually aged and/or disabled. These programs are an alternative to institutional care in a nursing facility in accordance with the waiver provisions of the SSA §1915(c).

• Agencies seeking contracts must select appropriate service category, and comply with applicable contract rules in addition to all applicable local, state, and federal regulations.

For more information on Medicare Waiver Contract Programs, you may review the DADS publication, Access and Intake Services Community Options.

Accreditation §97.521(f) DADS recognizes certain accrediting organizations as having standards that meet or exceed those enforced by DADS. Agencies that obtain accreditation are exempt from regular DADS surveys. There are three accrediting organizations: • The Community Health Accreditation Program (CHAP) is recognized by DADS for both

federal certification and state licensing standards. • The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is recognized

by DADS for both federal certification and state licensing standards. • The Accreditation Commission for Health Care (ACHC) is recognized by DADS for federal

certification standards but it is not recognized by DADS for state licensing purposes.

DADS conducts complaint investigations at all agencies, including accredited agencies.

Licensure Steps All HCSSAs must obtain a license. • Step 1: Complete the Application • Step 2: Complete the Presurvey Computer Based Training • Step 3: Submit the Application • Step 4: Begin Providing Services to Clients • Step 5: Request an Initial Survey • Step 6: Prepare for the Initial Survey • Step 7: Complete the Initial Survey



Step 1: Complete the Application §97.13(b) License applications may be requested by calling Consumer Rights and Services at 1-800-458-9858 to request an application packet, or you can visit the DADS website.

The website contains forms and instructions. The forms are in an interactive format that allows for downloading and completion.

When applying for a license, an applicant must not provide incorrect or false information; or withhold information.

Step 2: Complete the Presurvey Computer Based Training §97.13(a) HCSSA license applicants must verify that all required participants (administrators, alternate administrators, supervising nurses, and alternate supervising nurses) have successfully completed each required Presurvey Computer Based Training module with a score of 70% or higher by mailing or faxing their signed certificates of completion to DADS. DADS will not accept HCSSA license applications without these signed certificates.

Required participants must successfully complete: • Module 1: Introduction to the Presurvey Conference • Module 2: General HCSSA Licensure Standards • An additional module for each service category their agency will offer (Modules 3-7)

Step 3: Submit the Application §97.15; §97.31 DADS processes application packets within the time frames specified in §97.31. Complete and furnish all documents and information that DADS requests in accordance with the application instructions. All submitted documents must be notarized copies or originals. If DADS notifies you that some or all of the required information is missing or incomplete, you must complete the missing information and re-submit it to DADS.

If you decide not to continue the application process after submitting the application packet and license fee, submit to DADS a written request to withdraw the application. DADS does not refund the license fee. DADS issues an initial license when DADS determines: • The application packet and license fee are complete and correct; and • The applicant meets all criteria for licensing.

Please note that the HCSSA license is good for two years from the date of issuance. Be sure to read over the license to verify that all information on the license is correct.

Step 4: Begin Providing Services to Clients §97.15; §97.31 The rules for initial licensure surveys require that an agency admit at least one client and initiate services within six months of receiving an initial license.

There are some additional qualifications to this rule: • Agencies seeking Medicare certification must have admitted and provided skilled care to at

least 10 qualified patients before requesting an initial certification survey in writing. The request for initial licensure survey can be a separate request. Seven of the 10 qualified patients must be active on the day of survey. Note that care rendered to Medicare beneficiaries before the effective date of the agency’s Medicare provider number will NOT be reimbursed. For more information see S&C #01-02.

• Agencies seeking to provide licensed home health services with personal assistance services, or licensed only hospice with personal assistance services must have admitted at least one client in the licensed home health or licensed hospice category prior to requesting an initial survey.



Step 5: Request an Initial Survey §97.521(c)–(f) When the agency is ready for survey and has admitted its first client, it should notify the designated survey office in writing no later than six months after the effective date of the initial license, unless the agency is JCAHO or CHAP accredited.

The written request made using DADS Form 2020, must include the following: • The date of admission of the first client • The name of the client

The agency must include a list with each patient’s name, address, phone number, HIC or Social Security number, date of admission, and physician’s name, or use DADS Form 2020, Notification of Readiness for Initial Survey. Mail or fax the request to the designated survey office where the agency is located.

The agency is responsible for ensuring that it is, in fact, ready for survey before notifying DADS of its readiness. Not being ready for survey when the surveyors arrive to conduct the survey may result in citation of licensure violations or enforcement actions, including denial of license renewal.

Step 6: Prepare for the Initial Survey §97.521 All surveys are unannounced; however, there are certain things you can do to be ready for your survey. Have the following information available and ready for review: • A list of clients who are receiving services or who have received services from the agency

for each category of service licensed. • The client records for each client admitted during the licensing period before the initial

survey. • All required agency policies. • All personnel records of agency employees, including administrators supervising nurses, and

their alternates.

The supervising nurse and alternate must also include current registration with the BON or proof from the Compact Licensure State to indicate each is currently registered to practice nursing in Texas.

When stating your agency’s service area in your policies, you must identify the service area by county.

Step 7: Complete the Initial Survey §97.210(c); §97.523(a), (c), and (g); §97.525 For the initial survey, the administrator or alternate administrator must be: • Present at the entrance conference • Available in person or by telephone during the survey • Present in person at the exit conference

For the initial survey, the supervising nurse or alternate supervising nurse must be available in person or by telephone, if necessary, to provide information unique to the duties and functions of the position during the survey.

If an agency must close during normal operating hours, it should post a notice on its door, or in a visible exterior location, that provides information on how to contact the person in charge and leave a message on an answering machine or similar electronic mechanism providing information regarding how to contact the administrator or supervising nurse or their alternates.

If complying with these requirements causes an interruption in client care provided by the administrator, alternate administrator, supervising nurse, or the alternate supervising nurse, the agency must contact the backup service provider to provide services to ensure continued client care during the initial survey.



Important facts about DADS' survey procedures: • The surveyor must be given access to all agency records maintained by the agency or

maintained on behalf of the agency. • The surveyor may not remove records from the agency without the agency’s consent. • The agency must provide copies of agency records requested by the surveyor. • All categories of service on the license will be surveyed. • The surveyor will review any agency records which help to determine compliance with the

licensing requirements; the review will include a sample of clients receiving any specialized services such as pediatrics, G-tubes, or IV therapy.

• If violations are found, the initial survey may result in enforcement actions, including denial, revocation, or suspension of the license or administrative penalties.

MODULE II ~ GENERAL HCSSA LICENSING STANDARDS In this module we will review: • General Provisions of HCSSA Licensure • Minimum Standards for All HCSSAs • Additional Standards for Specific Services • Survey Requirements and Procedures • Basic Guidelines for DADS Enforcement Processes

General Provisions of HCSSA Licensure Statutory Authority §97.1 The Health and Safety Code (HSC) Chapter 142 authorizes DADS to adopt minimum standards that a person or entity must meet in order to be licensed as a HCSSA and to qualify to provide certified home health services.

Under the HSC, DADS adopted the rules at 40 TAC Chapter 97, to establish the minimum standards for acceptable quality of care and serve as a basis for licensure and survey activities.

A violation of a minimum standard is a violation of law. It is also a violation of the law to provide home health services without a license. DADS issues the license authorizing each place of business to provide these services. Licensure is a prerequisite for Medicare certification. Exemptions from the licensing requirement are found at HSC §142.003.

Limitations §97.1 Requirements established by private or public funding sources such as health maintenance organizations, insurance companies, Medicaid, Medicare, or state-sponsored funding programs are separate and apart from the requirements of 40 TAC Chapter 97.

No matter what funding sources or requirements apply to an agency, the agency must still comply with the applicable provisions in HSC Chapter 142, and 40 TAC Chapter 97.

The agency is responsible for researching availability of any funding sources to cover the services it provides.

Minimum Standards for All HCSSAs The information covered in this section, 40 TAC Chapter 97 Subchapter C, applies to ALL HCSSAs regardless of category.

Conditions of a License Agency Operating Hours §97.210 An agency must adopt and enforce a written policy identifying the agency’s operating hours. If an agency is closed during its operating hours or between the hours of 8:00 am and 5:00 pm, Monday through Friday, the person in charge must: • Post a notice in a visible location outside the agency with information on how to contact the

person in charge; and



• Leave a message on an answering machine or similar electronic mechanism to provide information on how to contact the person in charge.

Display of License §97.211 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. Upon entering the agency, the surveyor will look for the license.

Additional Key Points Regarding the Agency License Licenses may not be altered in any way and they must not be transferred from one location to another without prior notification to DADS.

Notification of Changes DADS must be notified of the following changes in accordance with procedures outlined in the HCSSA licensing rules: • Ownership - the new owner must obtain a new license • Agency relocation, including branch office and alternate delivery site affiliation with a

different parent agency • Telephone number and operating hours • Name • Accreditation status • Agency closure and voluntary suspension of operations • Organization and/or key personnel • License category, including deletions and additions • Service area

Administration The following pages review the rules governing the agency’s administration found in 40 TAC Chapter 97 Subchapter C Division 3.

Administrator §97.243(a)–(b) A license holder or the license holder’s designee must designate a qualified individual to serve as the administrator of the agency. A license holder or the license holder’s designee must also designate in writing a qualified alternate administrator to act in the absence of the administrator.

An administrator must be responsible for implementing and supervising the administrative policies of the agency and administratively supervising the provision of all services. At a minimum, the administrator must: • Organize and direct the agency’s ongoing functions • Ensure the documentation of services provided is accurate and timely • Employ or contract with qualified personnel • Ensure adequate staff education and evaluations (refer to §97.245) • Ensure accuracy of public information materials and activities • Implement an effective budgeting and accounting system that promotes the health and

safety of clients • Supervise and evaluate client satisfaction reports on all clients served

Qualifications §97.244(a) These qualifications must be met before a person can be designated as the administrator or alternate administrator.



For an agency with an LHHS, LCHHS, or Hospice category, the administrator and alternate administrator must: • 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; or

• 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.

For an agency with only the PAS category, the administrator and the alternate administrator must: • Have a high school diploma or a GED with at least one year experience or training in

caring for individuals with functional disabilities; or • Have completed two years of full-time study at an accredited college or university in a

health-related field; or • Meet the qualifications described for LHHS, LCHHS, or Hospice.

Conditions §97.244(b) These qualifications must be met before a person can be designated as the administrator or alternate administrator: • An administrator and alternate administrator must be able to read, write, and

comprehend English. • An administrator and alternate administrator must meet the training requirements. • 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 an enforcement actions specified in §97.244(b) against the agency while the person was the administrator of the cited agency.

• An administrator and alternate administrator must not be convicted of an offense described in 40 TAC Chapter 99 relating to Criminal Convictions Barring Facility Licensure during the time frames described in that chapter.

Training §97.259 - §97.260 A first -time administrator and alternate administrator of an agency must each have completed a total of 24 clock hours of training in the administration of an agency as described below before the end of the 12 months after designation to the position.

The 24-hours of training described above 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. The training must be provided and produced by: • An academic institution; • A recognized state or national organization or association; • An approved independent contractor who consults with agencies; or • An approved agency.

This rule applies only to an administrator or alternate administrator designated as an administrator or alternate administrator for the first time on or after December 1, 2006.

Prior to designation, a first-time administrator or alternate administrator must complete eight clock hours of educational training in the administration of any agency that includes information on the licensing standards for an agency and applicable state and federal laws.



A first-time administrator or alternate administrator must each complete an additional 16 clock hours of educational training on the following subjects within the first 12 months after designation to the position. The 16 clock hours may be completed prior to designation if completed during the 12 months immediately preceding the date of designation. The additional 16 clock hours should include the following topics listed in §97.259(c): • Information regarding fraud and abuse detection and prevention • Legal issues regarding advance directives • Client rights, including the right to confidentiality • Agency responsibilities • Complaint investigation and resolution • Emergency preparedness planning and implementation • Abuse, neglect, and exploitation • Infection control • Nutrition for agencies licensed to provide inpatient hospice services • The Outcome and Assessment Information Set (OASIS) for agencies licensed to provide

licensed and certified home health services

Documentation of administrator and alternate administrator training must be on file at the agency. Documentation should contain the name of the class or workshop, the course content, the hours and dates of the training, and the name and contact information of the entity and trainer who provided the training. An administrator or alternate administrator must complete 12 clock hours of continuing educational training within each 12 months after the date of designation to the position. The continuing education requirement must include at least two of the following topics: • Any one of the educational training subjects listed above • Development and interpretation of agency policies • Basic principles of management in a licensed health-related setting • Ethics • Quality improvement • Risk assessment and management • Financial management • Skills for working with clients, families, and other professional service providers • Community resources • Marketing

If you were an agency administrator or alternate administrator designated as an agency administrator or alternate administrator before December 1, 2006, but have 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).

Supervising Nurse Supervision of Services §97.243(c) An agency licensed to provide licensed home health services, licensed and certified home health services, or hospice services must directly employ or contract with a qualified individual to serve as the supervising nurse. The exception to this rule is found at §97.243(c)(3). An agency must designate in writing a similarly qualified alternate to serve as supervising nurse in the absence of the supervising nurse.

The supervising nurse or alternate supervising nurse must: • Be available to the agency at all times in person or by telephone • Participate in activities relevant to professional services furnished • Participate in development of qualifications and assignment of personnel



• Ensure the client’s plan of care or care plan is executed as written • Ensure that an appropriate health care professional performs a reassessment of client’s

needs, including when there is a significant health status change in the client’s condition, at the physician’s request; and after hospital discharge

This rule does NOT apply to the PAS category.

Qualifications §97.244(c) For an agency without a home dialysis designation, a supervising nurse and alternate supervising nurse must: • Be a registered nurse (RN) licensed in Texas or in accordance with the BON rules for

Nurse Licensure Compact (NLC); and • Have at least one year experience as an RN within the last 36 months.

Staffing Policies §97.245 An agency must adopt and enforce written staffing policies that govern all personnel used by the agency, including employees, volunteers, and contractors. The staffing policies must: • Include requirements for orientation to policies, procedures, and objectives of the agency • Include requirements for participation by all personnel in job-specific training • Address participation by all personnel in appropriate employee development programs • Include a written job description and job qualifications for each position at the agency • Include procedures for processing criminal history checks and searches of the Nurse Aide

Registry (NAR) and the Employee Misconduct Registry (EMR) for unlicensed personnel (refer to §97.247)

• Ensure annual evaluation of employee and volunteer performance • Address employee and volunteer disciplinary action and procedures • Address use of volunteers (refer to §97.248) • Include a requirement that all direct care staff and staff who have direct contact with clients

either employed by or under contract with the agency sign a statement that they have read, understand, and will comply with all applicable agency policies

Personnel Records §97.246 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: • 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

• An application for employment or volunteer agreement • Verification of license, permits, references, job experience, and educational requirements

as conducted by the agency to verify qualifications for each position accepted • Performance evaluations and disciplinary actions • The signed statement about compliance with agency policies required by §97.245(b)(10)

For an unlicensed employee and unlicensed volunteer whose duties would or do include face-to-face contact with a client, a personnel record must also include: • A printed copy of the results of the initial and annual searches of the NAR and EMR

obtained from the DADS website • Documentation that the employee in accordance with §97.247(a)(4), or volunteer in

accordance with §97.247(b)(4), received written information about the EMR

Agencies may keep personnel records for employees and volunteers in any location, but must provide them upon request of a DADS surveyor within eight working hours, as specified in §97.507(c).



Verification of Employability §97.247 • According to the HSC §253.008, home health agencies must conduct background checks

of unlicensed persons, volunteers, and contractors using the EMR and the NAR both before hire and annually. For more information see PL #10-37.

• Agencies may not employ any persons listed as unemployable in the EMR or NAR or having been found to have committed an act of abuse, neglect or exploitation against a HCSSA client or facility resident. (refer to §97.246, §97.247, and §97.289)

• According to §97.247, agencies must also conduct initial criminal history checks of unlicensed persons, volunteers, and contractors having face-to-face contact with agency clients. For more information see PL #06-48.

Self-Reported Incidents of Abuse, Neglect & Exploitation §97.249 The agency must adopt and enforce a written policy for reporting alleged acts of abuse, neglect, or exploitation of clients and reportable conduct by an employee, volunteer, or contractor of the agency. For additional information, see PL #06-36.

An agency that has cause to believe that a client has been abused, exploited, or neglected by an employee of the agency must report the information immediately to: • The Department of Family and Protective Services (DFPS) 1-800-252-5400 or secure

website at www.txabusehotline.org • DADS 1-800-458-9858

Investigations §97.250 Abuse, Neglect, and Exploitation HCSSAs must adopt and enforce a written policy regarding procedures for investigating complaints and reports of abuse, neglect and exploitation. When there is a report of abuse, neglect and exploitation, the agency must: • Initiate an investigation of known and alleged acts of abuse, neglect and exploitation by

agency employees, including volunteers and contractors, immediately upon witnessing the act or upon receiving allegation.

• Send a written report of the investigation using Form 3613 to DADS State Office no later than the 10th day after reporting the act to DADS and DFPS.

• 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 delay.

Other Investigations The agency must investigate complaints made by a client, a client’s family or guardian, or a client’s health care provider regarding treatment or care provided by the agency; treatment or care that the agency failed to provide; or lack of respect for the client’s property by anyone providing services on behalf of the agency.

Peer Review §97.251 Agencies 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. • Registered Nurses ~ Occupations Code Chapter 301 • Occupational Therapists ~ Occupations Code Chapter 454 • Physical Therapists ~ Occupations Code Chapter 453 • Social Workers ~ Occupations Code Chapter 505 • Speech Language Pathologists/Audiologists ~ Occupations Code Chapter 401 • For other professional disciplines, see the Occupations Code



Financial Solvency and Business Records §97.252; §97.254 An agency must: • Have the financial ability to carry out its functions • Not knowingly pay employees or contract staff with checks from accounts with insufficient

funds • Have sufficient funds to meet payroll • Make business records relating to its financial ability to carry out its functions available to

DADS upon request • Maintain business records in their original state • Have accurate and properly dated entries in its business records • Make corrections in accordance with standard accounting practices • Adopt and enforce a written policy to ensure that billings and insurance claims are accurate

Solicitation of Patients §97.255 Solicitation of clients/patients is prohibited by Occupations Code, Chapter 102.

A person commits an offense of solicitation if the person knowingly offers to pay or agrees to accept, directly or indirectly, overtly or covertly, any remuneration in cash or in kind to or from another for securing or soliciting a patient or patronage for or from a person licensed, certified, or registered by a state health care regulatory agency.

Emergency Preparedness §97.256; §97.403 Agencies must maintain compliance with emergency preparedness guidelines found in §97.256 and HSC §142.0201.

According to §97.256, an agency must have a written emergency preparedness and response plan, based on its risk assessment of most likely potential disasters from natural and man-made causes, that comprehensively describes its approach to a disaster that could affect the need for its services or its ability to provide those services.

With the exception of a freestanding hospice, DADS does not require an agency to physically evacuate or transport a client.

Freestanding hospice evacuation rules are found at §97.403(w)(2)(e). Freestanding inpatient hospices have additional requirements for ensuring client safety in a natural disaster. Refer to §97.256 and §97.403.

Emergency Preparedness Plan §97.256 In order to develop, maintain, and implement an emergency preparedness and response plan, an agency must: • Involve the administrator, supervising nurse, agency disaster coordinator and an alternate

disaster coordinator. • Designate by title one employee and at least one alternate to act as the agency's disaster

coordinator. • 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.

• 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.

• 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).

• Describe the actions and responsibilities of agency staff in each phase of emergency planning, including mitigation, preparedness, response, and recovery.



An agency must describe the following for the response and recovery phases of the plan: • The actions and responsibilities when warning of an emergency is not provided • Who at the agency will initiate each phase • A primary mode of communication and alternate communication or alert systems in the

event of telephone or power failure • Procedures for communicating with:

Staff Clients or persons responsible for a client's emergency response plan Local, state, and federal emergency management agencies Other entities including DADS and other healthcare providers and suppliers

An agency’s emergency preparedness and response plan must include procedures to triage clients that allow the agency to: • 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 • Categorize clients into groups based on:

The services the agency provides to a client The client’s need for continuity of the services the agency provides The availability of someone to assume responsibility for a client’s emergency

response

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: • Cannot provide or arrange for his or her transportation • Has special health care needs requiring special transportation assistance

If the agency identifies a client who may need evacuation assistance, agency personnel must provide the client with the amount of assistance the client requests to complete the registration process for evacuations assistance if the client: • Wants to register with the Transportation Assistance Registry, accessed by dialing 2-1-1 • Is not already registered, as reported by the client or legally authorized representative

An agency must provide and discuss the following information about emergency preparedness with each client: • The actions and responsibilities of agency staff during and immediately following an

emergency. • Client's responsibilities in the agency's emergency preparedness and response plan. • Materials that describe survival tips and plans for evacuation and sheltering in place. • A list of community disaster resources that may assist a client during a disaster, including

the transportation assistance registry available through 2-1-1, and other community disaster resource 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 resource directly or instruction to call 2-1-1 for more information about community disaster resources.

An agency must: • Orient and train employees, volunteers, and contractors about their responsibilities in the

agency's emergency preparedness and response plan. • 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. • As part of this annual internal review, test the response phase of the emergency

preparedness and response plan in a planned drill if not tested during an actual emergency response. Except for a freestanding hospice, a planned drill can be limited to the agency's procedure for communicating with staff.



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.

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.

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: • The date the record was reproduced • The agency staff member who reproduced the record • How the original record was damaged

An agency must notify and provide the following information to the DADS HCSSA licensing unit no later than five working days after any of the following temporary changes resulting from the effects of an emergency or disaster: • If temporarily relocating, the agency must provide DADS with the license number, date of

temporary relocation, the new physical address, phone number of the temporary location and the date an agency returns to a place of business after the temporary relocation.

• If temporarily expanding, the agency must provide DADS with the license number and revised boundaries of the service area, the date the expansion begins, and the date the expansion ends.

• The notice and information must be submitted by fax or e-mail. If fax and e-mail are unavailable, notifications can be provided by telephone, but must be provided in writing as soon as possible. If communication with the DADS licensing unit is not possible, an agency may fax, e-mail, or telephone the designated survey office to provide notification.

Provision and Coordination of Treatment and Services The following pages review the rules governing how the agency provides and coordinates treatments and services found in 40 TAC Chapter 97 Subchapter C Division 4.

Client Care Policies §97.281 An agency must adopt and enforce written policies that specify client care practices related to the scope of services it provides. The written policy must include the following elements if covered under the scope of services provided by the agency: • Initial assessment, reassessment • Start of care, transfer, and discharge • Intravenous services • Care of the pediatric client • Triaging clients in the event of disaster; how to handle emergencies in the home • Safety of staff • Procedures the staff will perform for clients • Psychiatric nursing procedures • Patient and caregiver teaching relating to disease process/procedures • Care of the dying patient/client • Care planning • Receiving physician orders • Performing waived testing, medication monitoring and anything else pertaining to client

care



Client Rights, Responsibilities, and Conduct §97.282 An agency must adopt and enforce a written policy governing client conduct and responsibility as well as client rights. The written policy must include a procedure by which a client may lodge a grievance without fear of reprisal. The agency must: • Protect and promote the client’s rights • Comply with provisions of HRC Chapter 102

At the time of admission, the agency must provide each client a written statement specifying where to direct complaints against the agency. The statement may also inform the client that a complaint against the agency may be directed to the administrator of the agency.

Before initiating care or treatments, the agency must provide each client, or their legal representative, a written notice of all policies governing client rights, responsibilities, and conduct.

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.

Advance Directives §97.283 An agency must maintain a written policy regarding implementation of advance directives. The policy must be in compliance with HSC 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 the advance directive.

The agency must provide written notice to an individual of the advance directives policy at the earlier of: • The time of admission to receive services • The time the agency begins providing care to the individual

DADS may assess an administrative penalty of $500 against an agency that violates the requirement for the provision of a written statement regarding advance directives.

Infection Control §97.285 An agency must adopt and enforce written policies addressing infection control, including preventing the spread of infectious and communicable diseases. The policies must ensure compliance by the agency, employees, and contractors with: • Communicable Disease Prevention and Control Act, HSC Chapter 81 • Occupational Safety and Health Administration (OSHA), Title 29 CFR Part 1910.1030 and

Appendix A, relating to Bloodborne Pathogens • HSC Chapter 85 Subchapter I, concerning preventing the transmission of human

immunodeficiency virus and hepatitis B virus

The policies must also require documentation of infections that the client acquires while receiving services from the agency. There are different requirements for documentation of infections for PAS-only agencies.

Disposal of Special or Medical Waste §97.286 An agency must adopt and enforce a written policy for the safe handling and disposal of biohazardous waste and materials, if applicable.

The agency must provide both verbal and written instructions to clients regarding the proper procedure for disposing of sharps.

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.



Quality Assessment & Performance Improvement §97.287 An agency must maintain a Quality Assessment and Performance Improvement (QAPI) program that is implemented by a QAPI committee. At a minimum, the QAPI committee must consist of the administrator; the supervising nurse or therapist, or the supervisor of an agency licensed to provide personal assistance services; and an individual representing the scope of services provided by the agency. The QAPI committee must meet twice a year or more often, if needed.

Maintenance of QAPI Program The QAPI program must: • Be ongoing • Be focused on client outcomes that are measurable • Have a written plan of implementation

System of Measures The program must include a system that measures significant outcomes for optimal care; and an annual evaluation of the total operation, including services provided under contract or arrangement. The QAPI committee must use the measures in care planning and coordination of services and events. The measures must include as appropriate for the scope of services provided by the agency an analysis of services furnished to clients contained in active and closed records and a review of: • Negative client outcomes • Complaints and incidents of unprofessional conduct by licensed staff and misconduct by

unlicensed staff • Infection control activities • Medication administration and errors • Effectiveness and safety of all services provided, including competency of the agency's

clinical staff, promptness of service delivery; and appropriateness of the agency's responses to client complaints and incidents

The measures must also include a determination that services have been performed as outlined in the service plan, care plan, or plan of care; and an analysis of client complaint and satisfaction survey data.

Coordination of Services §97.288 An agency must adopt and enforce a written policy that requires effective coordination of care with all service providers involved in the care of a client; this includes physicians, contracted health professionals, and other agencies. The agency must document, in the client’s record, steps that were taken to coordinate services.

Independent Contractors & Arranged Services §97.289 If an agency uses independent contractors, the agency must have a contract with each independent contractor that performs services. The contract must be enforced by the agency and clearly designate: • That clients are accepted for care only by the agency • Services to be provided by the contractor and how they will be provided • The necessity of the contractor to conform to all applicable agency policies, including

personnel qualifications • The contractor's responsibility for participating in developing the plan of care, care plan or

individualized service plan • The manner in which services will be coordinated and evaluated by the agency in

accordance with §97.288



• The procedures for submitting information and documentation by the contractor in accordance with the agency's client record policies; scheduling of visits by the contractor or the agency; periodic client evaluation by the contractor; and determining charges and reimbursement payable by the agency for the contractor's services under the contract

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 requirements specified in §97.289.

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: • Searches the NAR and the EMR before the unlicensed person's first face-to-face contact

with a client of the agency using the DADS website to confirm that the unlicensed person is not listed in either registry as unemployable.

• Provides written information to the unlicensed person about the EMR that complies with the requirements of §93.3(c).

• Searches the NAR and the EMR at least every twelve months using the DADS website to confirm that the person is not listed in either registry as unemployable.

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 conducts a criminal history check before the unlicensed person's first face-to-face contact with a client of the agency; and verifies that the unlicensed person's criminal history information does not include a conviction that bars employment under the HSC §250.006.

An agency is not required to maintain a personnel record for independent contractors or staff who provides 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: • That independent contractors or staff under arrangement meet the agency's written job

qualifications for the position and duties performed. • The agency ensures compliance with §97.289(c) for unlicensed staff providing services to

the agency's clients under arrangement. • The agency complies with §97.289(d) 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 HSC §250.006.

Backup Services & After Hours Care §97.290 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.

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 and has signed a written agreement to be the backup service provider.

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.



Agency Dissolution §97.291 The agency must adopt and enforce a written policy that describes the agency’s contingency plan. The plan must: • Be implemented in the event of dissolution to assure continuity of client care • Be consistent with §97.295 • Comply with §97.217(a)(2)

See the closure requirements in §97.604 for additional requirements.

Agency and Client Agreement & Disclosure §97.292 An agency must provide the client or the client’s family a written agreement for services and obtain an acknowledgement of receipt of this written agreement, which includes: • Notification of client rights • Documentation that client was notified of the availability of medical power of attorney for

health care, advanced directives, or ‘Do-Not-Resuscitate’ orders • Services to be provided • Supervision by the agency of services provided • 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 • A written statement that has procedures for filing a complaint in accordance with

§97.282(d) • A client agreement to and acknowledgement of services by home health medication aides

Client List and Services §97.293 An agency must maintain a current list of clients for each category of service licensed. The list must include: • The client’s name • The identification or clinical record number • The start of care date or admission date • The certification period (if applicable) • Diagnosis or functional assessment (as appropriate) • All services delivered to the client by the agency and under contract • All disciplines providing services

Initiation of Care §97.294 An agency must adopt and enforce a written policy establishing the time frame for initiating care or services.

Client Transfer or Discharge §97.295 Notification Except in an emergency, an agency intending to transfer or discharge a client must provide written notification to the client or the client’s parent, family, spouse, significant other, or legal representative; and notify the client’s attending physician or practitioner if he is involved in the agency’s care of the client.

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

If the agency delivers the written notice by mail: • The notice must be mailed at least eight working days before the date of discharge or

transfer. • 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.



Documentation An agency must keep the following in the client’s file: • A copy of the written notification provided to the client or the client’s parent, family,

spouse, significant other, or legal representative. • Documentation of the personal contact with the client if the required notice was delivered

by mail. • Documentation that the client’s attending physician or practitioner was notified of the

date of discharge.

Physician Delegation §97.296 Requirements An agency must adopt and enforce a written policy that states whether 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.

Accepting Physician Delegation Physician delegation may be accepted if the following are received from the physician: • The name of the client • The name of the delegating physician • The tasks to be performed • The names of the individuals to perform the tasks • The time frame for the delegation order • If the task is medication administration, the medication to be given, route, dose, and

frequency

Receipt of Physician's Orders §97.297 Policy Requirement An agency must adopt and enforce a written policy describing protocols and procedures agency staff must follow when receiving physician’s orders.

Verbal Orders The policy must address the time frame for countersignature of physician verbal orders.

Faxed Physician Orders Signed physician orders may be submitted via fax machine. The agency is not required to have the original signature on file but must be able to obtain an original signature if an issue surfaces that would require verification of an original signature.

Nurse Delegation §97.298 An agency must adopt and enforce a written policy to ensure compliance with the following rules adopted by the BON for the State of Texas: • 22 TAC Chapter 224 • 22 TAC Chapter 225

Requirements for RN delegation for personal assistance services clients are located at §97.404.

Medication Administration §97.300 An agency must adopt and enforce a written policy for maintaining a current medication list and a current medication administration record for clients to whom agency staff administers medications. Administration of medications must be ordered by the client’s practitioner.



The medication list must be used to identify: • Possible ineffective drug therapy • Adverse reactions • Significant side effects • Drug allergies • Contraindications

The agency must document in the medication administration record or clinical notes any medication that is not administered and the reason why it was not administered.

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.

Client Records §97.301 An agency must establish and maintain a client record system to ensure that care and services provided are completely and accurately documented, readily accessible, and systematically organized to facilitate the compilation and retrieval of information. The agency must: • Establish a record for each client • Adopt and enforce written procedures regarding use and removal of records, release of

information, and the incorporation of clinical, progress, or other notes into the record • Establish an area for original client record storage at the agency’s place of business • Protect information against loss or damage • Ensure that each record is treated with confidentiality, is safeguarded against loss and

unofficial use, and is maintained according to professional standards of practice

The clinical record must be original, a microfilmed copy, an optical disc imaging system, or a certified copy. A signed paper record may include a physician’s stamped signature if certain requirements are met.

Computerized records must meet all requirements of paper records, including protection from unofficial use and retention for a minimum of five years after the discharge of the client.

The client record must include the following, as applicable to the scope of services provided: • Application for services that includes all required information • Initial health assessment, pertinent medical history, and subsequent health assessments • Care plan, plan of care, or individualized service plan • Clinical and progress notes, which must be written the day service is rendered and

incorporated into the client record within 14 working days • Current medication list (if medication is administered by agency staff) • Medication administration record (if medication is administered by agency staff) • Records of supervisory visits • Complete documentation of all known services and significant events • Acknowledgement of receipt of a copy of the Rights of the Elderly (clients 60 yrs & older) • Acknowledgement of client’s receipt of the agency’s policy regarding abuse, neglect, or

exploitation of clients • Documentation the client has been informed of how to register a complaint • Discharge summary that includes the reason for the discharge • Client agreement to and acknowledgment of services by home health medication aides, if

home health medication aides are used • Acknowledgement of receipt of the notice of advance directives • Services provided to the client's family (as applicable) • Consent and authorization and election forms (as applicable)



Pronouncement of Death §97.302 An agency must adopt and enforce a written policy on pronouncement of death if that function is carried out by an agency RN. The policy must be in compliance with HSC §671.001.

Branch Offices The following pages review the rules governing branch offices found in 40 TAC Chapter 97 Subchapter C Division 5.

Application of Regulations §97.321(a)-(b); §97.402 A branch office operates as 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 the licensing standards.

A branch office providing licensed and certified home health services must comply with the standards for certified agencies.

Service Areas §97.321(c) There are five important facts to keep in mind about service areas. • The service area of a branch office must be located within the parent agency’s service

area. • A branch office must not provide services outside its licensed service area. • A branch office must maintain adequate staff to provide services and to supervise the

provision of services within the service area. • A branch office may expand its service area at any time during the licensure period.

Unless exempted, a branch office must submit to DADS a written notice to expand its service area at least 30 days before the expansion.

• 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.

Requirements §97.243(d)(1); §97.321(d) & (f) 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. • The original active client record must be kept at the branch office. • The parent agency must approve all branch office policies and procedures. This approval

must be documented and filed in the parent and branch offices. • 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. • An agency must adopt and enforce a written policy relating to the supervision of branch

offices, if established.

Enforcement Issues §97.321(e) • Issuance or renewal of a branch office license is contingent upon compliance with the

statute and 40 TAC Chapter 97, by the parent agency and the branch office. • DADS may take enforcement action against a parent agency license for a branch office’s

failure to comply with laws or rules. • Revocation, suspension, denial, or surrender of a parent agency license will result in the

same action being taken for all branch office licenses of the parent agency.



Additional Standards for Specific Services Agencies offering services, such as psychoactive services, home intravenous therapy, and pediatric clients, must adhere to the applicable rules.

Psychoactive Services §97.406 An agency must adopt and enforce a written policy relating to the provision of psychoactive treatments consistent with §97.406.

Skilled nursing psychoactive treatments must be under the direction of a physician. Psychoactive treatments may only be provided by a physician or a registered nurse.

A registered nurse providing skilled nursing psychoactive treatments must be qualified. The agency must have written documentation of this person’s qualifications.

The initial health assessment of a client receiving skilled nursing psychoactive treatments must include five components: • Mental status including psychological and behavioral status • Sensory and motor function • Cranial nerve function • Language function • Any other criteria established by an agency’s policy

Home Intravenous Therapy §97.407 General Requirements A physician’s order must be written specifically for intravenous therapy. Care coordination must be provided in order to ensure continuity of care. Written policies and procedures regarding the agency’s provision of intravenous therapy must include, but are not limited to, addressing initiation, medication administration, monitoring, and discontinuation. Actions must be implemented prior to and during all intravenous therapy to minimize the risk of anaphylaxis or other adverse reactions as stated in the agency’s written policy.

Nursing Services Intravenous therapy must be provided by a licensed nurse. To ensure that prescribed care is administered safely, the licensed nurse must have the knowledge and documented competency to interpret and implement the written order. The responsibilities of the licensed nurse must be clearly delineated in written policies and procedures. A registered nurse must be available 24 hours a day.

Client and Caregiver Role The client and caregiver must be assessed for the ability to safely administer the prescribed intravenous therapy as per agency written criteria. If the client or caregiver is willing and able to safely administer the prescribed intravenous therapy, the agency must offer to teach the client or caregiver such administration. An ongoing assessment of client and caregiver compliance in performing intravenous therapy related procedures must be done at periodic intervals. The client and caregiver must be provided with 24-hour access to appropriate health care professionals employed by or having a contract with the agency.

Pediatric Clients Staffing Policies §97.245(b)(9) An agency’s written staffing policies must 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 competence in the care of pediatric clients.

Client Care Practices §97.281(4) If pediatric clients are served by the agency, the agency must adopt and enforce a written policy that specifies the agency’s client care practices for the care of pediatric clients.



Client Records §97.301(a)(9)(A) A pediatric client’s record must include client application for services including, but not limited to: • Full name • Sex • Date of birth • Name, address, and telephone number of parents of a minor child, or legal guardian, or

others as identified by the individual • Physician’s name and telephone numbers, including emergency numbers • Services requested

Directive to Physicians HSC §166.035 & §166.085 The following persons may execute a directive on behalf of a qualified patient who is younger than 18 years of age: • The patient’s spouse, if the spouse is an adult • The patient’s parents • The patient’s legal guardian

A written directive executed under these rules is effective without regard to whether the document has been notarized. Consequently, a physician, health care facility, or health care professional may not require that the directive be notarized or that a person use a form provided by the physician, health care facility, or health care professional.

Survey Requirements and Procedures General Provisions §97.2(95); §97.210(c); §97.505; §97.507; §97.509 The survey determines if the agency is meeting requirements of the statute and licensing rules. The surveyor may conduct an on-site survey at reasonable times during business hours defined as 8:00am - 5:00pm, Monday through Friday and at times considered necessary in order to ensure compliance with regulations.

Surveys are unannounced in that DADS does not give prior notice of a survey.

By applying for and holding a license, the agency consents to entry and survey by DADS. If the agency does not cooperate with the survey, DADS may take enforcement action to deny, revoke, or suspend the license.

If an agency is applying for or renewing a branch office or alternate delivery site license, a survey covers all locations. Also, if an agency is applying for a license to provide more than one category of service, a survey covers all provided services of the agency.

The requirements for an initial survey are found in §97.521.

For more information on what to expect during your agency's survey, please see PL #11-01.

Survey Frequency §97.501; §97.502 An initial survey is conducted after the agency notifies DADS that it is ready for survey. After the initial survey, the agency will be surveyed within 18 months; subsequent surveys will be conducted at least every 36 months thereafter.

Surveys are also conducted to investigate complaints regarding: • The provision of licensed home health services, licensed and certified home health services,

hospice services, or personal assistance services that are alleged to have violated 40 TAC Chapter 97, or HSC Chapter 142.

• The provision of licensed and certified home health services or hospice services that are alleged to be out of compliance with federal requirements.

• Complaints or self-reported incidents where the alleged victim of abuse, neglect or exploitation is an agency client and the alleged perpetrator of the abuse, neglect, or exploitation is an employee, volunteer, or contractor.



A survey may be conducted for the renewal of a license or the issuance of a branch office or alternate delivery site license.

Staff Availability During Surveys §97.523(a)–(c) According to §97.523(a)-(c), administrators, supervising nurses and their alternates must be available during surveys.

Administrator and Alternate Administrator For an initial survey, the administrator or alternate administrator must be present at the entrance conference, available in person or by telephone during the survey, and present in person at the exit conference. For a survey other than an initial survey, the administrator or alternate administrator must be available in person or by telephone during the entrance conference and the survey, and must be present in person at the exit conference.

Supervising Nurse and Alternate Supervising Nurse The supervising nurse or alternate supervising nurse must be available in person or by telephone, if necessary, to provide information unique to the duties and functions of the position during the survey.

Surveyor Entry §97.210(c); §97.523(d)–(f) If the surveyor arrives to conduct a survey during the agency’s regular business hours or between the hours of 8:00am and 5:00pm and finds the agency closed, the administrator, alternate administrator, or designated agency representative must provide the surveyor entry within two hours after the surveyor’s arrival at the agency.

The agency representative who may grant entry to a surveyor must be designated in writing by the administrator.

If the required personnel are not available, the surveyor may recommend an enforcement action against the agency.

If an agency is closed during operating hours, or between 8:00am and 5:00pm, Monday through Friday, a note providing information on how to contact the person in charge must be posted in a visible location outside the agency.

Survey Procedures §97.525, PL #11-01 Before beginning the survey, the surveyor holds an entrance conference with agency personnel to inform the agency of the purpose of the survey. The surveyor explains the survey process and provides agency personnel with the opportunity to ask questions. All attendees must sign the entrance conference attendance sheet.

The surveyor will explain that: • If the agency is Licensed and Certified (LCHHS), a minimum of 11 clinical records will be

reviewed, including both active and discharged records. • If the agency provides Licensed Home Health (LHHS) or Personal Assistance Services

(PAS), a minimum of 10 clinical records will be reviewed, including both active and discharged records.

• A minimum of 3 client home visits will be conducted, depending on the number of clients the agency serves.

• The following agency systems will be reviewed: Administrative records; Complaint tracking system; Quality assurance plan and activities; Policies and Procedures; and Employee files and qualifications.

The surveyor will communicate openly with you throughout the survey. The surveyor will require copies of documentation reviewed. The copies assist the surveyor in determining survey findings.



Post-Survey Procedures §97.527(a)–(f) After completing the survey, the surveyor conducts an exit conference with agency representatives. During this conference, the surveyor will provide and review a list of preliminary findings. All persons present at the exit conference must sign the exit conference attendance sheet. You will also be given an opportunity to submit an evaluation of the survey.

The agency may submit additional written documentation to DADS after the exit conference only if the additional documentation and facts were described to the surveyor during the exit conference. The additional written documentation and facts must be submitted to the designated survey office within two working days after the end of the exit conference.

If additional violations or deficiencies are identified after the exit conference, another face-to-face exit conference will be held with the agency.

Official written notification of survey findings will be provided to the agency within 10 working days after the exit conference. Written notification includes a statement of violations and instructions for submitting an acceptable plan of correction. The agency will be informed of procedures for requesting an informal review of any deficiencies or violations cited.

Severity of Violations §97.527(g)(2)(A)-(D) Violations are classified by severity as Severity Level A and Severity Level B. • A Severity Level A violation is a minor violation. • A Severity Level B violation is a violation that results in serious harm or death of a client;

constitutes a serious threat to the health or safety of a client; or substantially limits the agency’s capacity to provide care.

Plan of Correction §97.527(g)-(j) The agency must submit an acceptable plan of correction for each violation or deficiency no later than 10 days following receipt of the official written notification of the survey findings. An acceptable plan of correction includes the corrective measures and the time frame with which the agency must comply to ensure correction of a violation.

If DADS finds the plan of correction unacceptable, the agency receives written notice and is provided one additional opportunity to submit an acceptable plan of correction. The revised plan of correction must be submitted no later than 30 days after receiving written notice that the original plan of correction was not acceptable.

If the agency fails to submit an acceptable plan of correction, DADS may recommend enforcement action against the agency.

If the agency fails to correct each violation or deficiency by the date on the plan of correction, enforcement action may be taken against the agency.

An agency must submit a plan of correction in response to an official written notification of survey findings that declares a violation or deficiency, even if the agency disagrees with the survey findings.

The agency will receive instructions for how to write a plan of correction with the official written notification of survey findings.

Time Frames for Correcting Violations §97.527(g)(1)–(3) As explained earlier, TAC classifies violations based on their severity. Minor violations are classified as ‘Severity Level A’ and major violations are classified as ‘Severity Level B’. This classification system is discussed in detail in the ‘Enforcement’ section of this course. • If the violation is Severity Level B and results in serious harm or death of a client or

constitutes a serious threat to the health or safety of a client, the agency must address it immediately and correct it within 2 days.



• If the violation is Severity Level B and substantially limits the agency’s capacity to provide care, the agency must correct it within 7 days.

• If the violation is Severity Level A that has or had minor or no health or safety significance, the agency must correct it within 20 days.

• If the violation is not designated as either Severity Level A or Severity Level B, the agency must correct it within 60 days.

Informal Review of Deficiencies (IRoD) §97.527(g)(4) and (i)–(k) If the agency disagrees with the survey findings, it may request an IRoD. The IRoD is an informal administrative process and is requested when the agency disagrees with a cited licensure violation or Medicare deficiency. It allows the agency to refute the citation and demonstrate compliance. An acceptable plan of correction must be submitted for each deficiency or violation cited, including the one in question.

As a result of the IRoD, the deficiency or violation may: • Be deleted • Have a portion deleted • Have evidence moved to a more appropriate tag or TAC section • Be sustained

For additional direction regarding how to request an IRoD, please see PL #11-15.

The agency will receive instructions for how to request an IRoD with the official written notification of the survey findings.

Basic Guidelines for DADS Enforcement Processes This section will review the enforcement process found in 40 TAC Chapter 97 Subchapter F.

Enforcement Actions §97.601(a) DADS may take one of the following enforcement actions against an agency: • Denial of license application • License suspension or revocation • Administrative penalties • Immediate license suspension or revocation

Denial of License Application §97.601(b) DADS may deny a license application for the reasons set out in §97.21.

License Suspension or Revocation §97.601(c); HSC §142.011(c) DADS may suspend or revoke an agency’s license if the license holder, the controlling person, the affiliate, the administrator, or the alternate administrator: • Fails to comply with 40 TAC Chapter 97 • Fails to comply with the statute • Engages in conduct that violates Occupations Code Chapter 102

DADS may also suspend or revoke an agency’s license to provide licensed and certified home health services if the agency fails to maintain its Medicare certification.

Administrative Penalties §97.601(d) DADS may assess an administrative penalty against an agency. DADS may consider the assessment of past administrative penalties when considering another enforcement action against an agency. Administrative penalties are discussed in greater detail later in this course.

Immediate License Suspension or Revocation §97.601(e) DADS may immediately suspend or revoke an agency’s license when the health and safety of persons are threatened. If DADS issues an order for immediate suspension or revocation of the agency’s license, DADS provides immediate notice to the controlling person, administrator, or



alternate administrator of the agency by fax and either by certified mail with return receipt requested or hand delivery.

An order for immediate suspension or revocation goes into effect immediately. An agency is entitled to a formal administrative hearing not later than seven days after the effective date of the order for immediate suspension or revocation.

Opportunity to Show Compliance §97.601(f)–(h) Before revocation or suspension of an agency’s license or denial of an application for the renewal of an agency’s license, DADS gives the license holder a notice by personal service or by registered or certified mail of the facts or conduct alleged to warrant the proposed action, with a copy sent to the agency; and an opportunity to show compliance with all requirements of law for the retention of the license by sending DADS Regulatory Services office a written request.

The request must: • Be postmarked within 10 days of the date of DADS notice and be received in DADS

Regulatory Services office within 10 days of the date of the postmark • Contain specific documentation refuting DADS allegations

DADS limits its review to the documentation submitted by the license holder and information DADS used as the basis for its proposed action. An agency may not attend DADS’ meeting to review the opportunity to show compliance. DADS gives a license holder a written affirmation or reversal of the proposed action.

After an opportunity to show compliance, DADS sends a license holder a written notice that: • Informs the license holder of DADS decision • Provides the agency with an opportunity to appeal DADS decision through a formal hearing

process

An applicant or license holder has the right to make a formal appeal after receipt of DADS’ notification of denial of an application for an initial license or renewal of a license and suspension or revocation of a license.

Surrender of License §97.601(i) Upon suspension, revocation, or nonrenewal of a license, the license holder must: • Return the original license to DADS • Follow its contingency plan in accordance with §97.291

Administrative Penalties §97.602 DADS may assess an administrative penalty against a person who violates HSC Chapter 142; a provision in 40 TAC Chapter 97 for which a penalty may be assessed; or Occupations Code Chapter 102, if related to the provision of home health, hospice, or personal assistance services.

The schedule of appropriate and graduated penalties for each violation is based on the following criteria: • The seriousness of the violation, including the nature, circumstances, extent, and gravity of

the violation and the hazard of the violation to the health or safety of clients • The history of previous violations by a person or a controlling person with respect to that

person • Whether the affected agency identified the violation as part of its internal quality assurance

process and made a good faith, substantial effort to correct the violation in a timely manner • The amount necessary to deter future violations • Efforts made to correct the violation • Any other matters that justice may require

In determining which violation warrants a penalty, DADS considers the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation, the hazard of the



violation to the health or safety of clients; and whether the affected agency identified the violation as part of its internal quality assurance program and made a good faith, substantial effort to correct the violation in a timely manner.

Except as provided in §97.602(e) and (f), DADS provides an agency with an opportunity to correct a violation in accordance with the time frames established in §97.527(g)(2) before assessing an administrative penalty if a plan of correction has been implemented. • DADS may not assess an administrative penalty for a minor violation unless the violation is

of a continuing nature or is not corrected in accordance with an accepted plan of correction. • DADS may assess an administrative penalty for a subsequent occurrence of a minor

violation when cited within three years from the date the agency first received written notice of the violation.

• DADS does not assess an administrative penalty for a subsequent occurrence of a minor violation when cited more than three years from the date the agency first received written notice of the violation.

DADS may assess an administrative penalty without providing an agency with an opportunity to correct a violation if DADS determines that the violation: • Results in serious harm to or death of a client • Constitutes a serious threat to the health or safety of a client • Substantially limits the agency's capacity to provide care • Involves the provisions of HRC Chapter 102

DADS may assess an administrative penalty without providing an agency with an opportunity to correct a violation if DADS determines that the violation is a violation in which a person: • Makes a false statement that the person knows or should know is false of a material fact on

an application for issuance or renewal of a license or in an attachment to the application; or with respect to a matter under investigation by DADS.

• Refuses to allow a representative of DADS to inspect a book, record, or file required to be maintained by an agency.

• Willfully interferes with work of a representative of DADS or enforcement of Chapter 97. • Willfully interferes with a representative of DADS preserving evidence of a violation of this

chapter or a rule, standard, or order adopted or license issued under Chapter 97. • Fails to pay a penalty assessed by DADS under this chapter not later than the 10th day after

the date the assessment of the penalty becomes final. • Fails to submit a plan of correction not later than the 10th day after the date the person

receives a statement of licensing violations; or an acceptable plan of correction not later than the 30th day after the date the person receives notification from DADS that the previously submitted plan of correction is not acceptable.

In regard to advance directives, as provided in HSC §142.0145, DADS assesses an administrative penalty of $500 for a violation of §97.283 without providing an agency with an opportunity to correct the violation.

Administrative penalties vary between $100 and $1,000 for each violation, and have three ranges for different types of violations. Each day that a violation occurs before the date on which the person receives written notice of the violation is considered one violation. Each day that a violation occurs after the date on which an agency receives written notice of the violation constitutes a separate violation. • A Severity Level A violation is a violation that has or has had minor or no client health or

safety significance. DADS assesses a penalty for a Severity Level A violation only if the violation is of a continuing nature or was not corrected in accordance with an accepted plan of correction. The penalty range for a Severity Level A violation is $100 - $250 per violation. DADS may assess a separate Severity Level A administrative penalty for each of the rules listed in the table.



• A Severity Level B violation is a violation that results in serious harm to or death of a client; constitutes an actual serious threat to the health or safety of a client; or substantially limits the agency's capacity to provide care. The penalty for a Severity Level B violation that results in serious harm to or death of a client is $1,000; those that constitute an actual serious threat to the health or safety of a client are $500- $1,000; and those that substantially limit the agency's capacity to provide care are $500-$750. As provided in §97.602(e), a Severity Level B violation is a violation for which DADS may assess an administrative penalty without providing an agency with an opportunity to correct the violation. DADS may assess a separate Severity Level B administrative penalty for each of the rules listed in the table.

If DADS assesses an administrative penalty, DADS provides a written notice of violation letter to an agency which includes a brief summary of the violation; the amount of the proposed penalty; and a statement of the agency's right to a formal administrative hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty. An agency may accept DADS determination not later than 20 days after the date on which the agency receives the notice of violation letter, including the proposed penalty, or may make a written request for a formal administrative hearing on the determination. • If an agency notified of a violation accepts DADS determination, the DADS commissioner or

the commissioner's designee issues an order approving the determination and ordering that the agency pay the proposed penalty.

• If an agency notified of a violation does not accept DADS determination, the agency must submit to the HHSC a written request for a formal administrative hearing on the determination and must not pay the proposed penalty. Remittance of the penalty to DADS is deemed acceptance by the agency of DADS determination, is final, and waives the agency's right to a formal administrative hearing.

• If an agency notified of a violation fails to respond to the notice of violation letter within the required time frame, the DADS commissioner or the commissioner's designee issues an order approving the determination and ordering the agency pay the proposed penalty.

• If an agency requests a formal administrative hearing, the hearing is held in accordance with HSC §142.0172 & §142.0173, and the formal hearing procedures in 1 TAC Chapter 357, Subchapter I.

Other Enforcement Actions Court Actions §97.603 If a person operates an agency without a license, the person is liable for a civil penalty of not less than $1,000 or more than $2,500 for each day of violation. If a person violates the licensing requirements of the statute, DADS may petition the district court to restrain the person from continuing the violation.

Surrender or Expiration of a License §97.604 After a survey in which a surveyor cited deficiencies, an agency may surrender its license or allow its license to expire to avoid enforcement action by DADS.

If an agency surrenders its license before the expiration date, the agency must return its original license and provide the following information to DADS: • The effective date of closure • The location of client records • The name and address of the client record custodian • A statement signed & dated by the license holder agreeing to the surrender of the license • The disposition of active clients at the time of closure

If an agency surrenders its license or allows its license to expire, DADS denies an application for license by the agency, its license holder, and its affiliate for one year after the date of the surrender or expiration.

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