Proposed Rules Title 26

TITLE 26. HEALTH AND HUMAN SERVICES

PART 1. HEALTH AND HUMAN SERVICES COMMISSION

CHAPTER 509. FREESTANDING EMERGENCY MEDICAL CARE FACILITIES

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes new rules in Texas Administrative Code Title 26, Part 1, Chapter 509, concerning Freestanding Emergency Medical Care Facilities. The new chapter consists of §§509.1, 509.2, 509.21 - 509.30, 509.41 - 509.66, 509.81 - 509.86, and 509.101 - 509.108.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with House Bill (H.B.) 2041 and H.B. 1112, 86th Legislature, Regular Session, 2019, which amended Texas Health and Safety Code (HSC) Chapter 254, relating to the regulation of Freestanding Emergency Medical Care Facilities. H.B. 2041 requires freestanding emergency medical care (FEMC) facilities to comply with updated advertising requirements, which includes disclosure of facility fees and clarification of health benefit plans that are accepted by the facility, and it requires FEMC facilities to provide a disclosure statement to patients. H.B. 2041 requires an FEMC facility that closes or whose license is expired, suspended, or revoked to remove their signs from the facility. H.B. 1112 similarly requires a closed FEMC facility or an FEMC facility whose license is expired, suspended, or revoked to remove their signage. This proposal also complies with Senate Bill (S.B.) 425, 84th Legislature, Regular Session, 2015, which amended HSC Chapter 254 to require an FEMC facility to post a notice regarding facility fees and provide other consumer information to patients.

A previous version of these rules was proposed in the January 22, 2021, issue of the Texas Register (46 TexReg 520) and expired without being adopted. This new version takes into account comments HHSC received during the previous public comment period, and the public will have another 31-day period to comment on this new version of these proposed rules.

The proposal will also revise sections in the subchapters on Inspection and Investigation Procedures and Enforcement to outline facility documentation expectations to increase consistency across facility rule sets, update language to reflect the transition to HHSC and the relocation of rules from Title 25 to Title 26, and correct outdated references and citations.

To implement this change, rules in Title 25 Chapter 131, Freestanding Emergency Medical Care Facilities, are being repealed and new rules proposed in Title 26 Chapter 509, Freestanding Emergency Medical Care Facilities. The repeal of Title 25 Chapter 131 is proposed elsewhere in this issue of the Texas Register.

SECTION-BY-SECTION SUMMARY

Proposed new Subchapter A, General Provisions, composed of §509.1 and §509.2, provides the purpose of the chapter and definitions used in the chapter. This new subchapter is consistent with the previous Title 25 Chapter 131, Subchapter A, but with edits to correct outdated titles, remove a term not used in the chapter, and update contact information.

Proposed new Subchapter B, Licensing Requirements, composed of §§509.21 - 509.30, provides guidelines on application for initial and renewal licensure, facility closures, facility types, changes of ownership, and fees. Section 509.26, Inactive Status and Closure, updates the previous language in repealed Title 25 §131.27 to clarify the inactive status and closure guidelines for a facility that does not provide services under its license for more than five calendar days. This section also implements H.B. 1112 and H.B. 2041 to require a facility remove signs indicating that the facility is in operation from within view of the general public when it closes or its license is expired, suspended, or revoked. Section 509.30, Fees, increases the term for initial and renewal licenses from one year to two years and accordingly doubles the corresponding license fees because that amount is reasonable and necessary to defray the cost of administering Texas Health and Safety Code Chapter 254 over that timeframe. This new subchapter is consistent with the previous Title 25 Chapter 131, Subchapter B, but with edits to correct citations and remove outdated information.

Proposed new §§509.41 - 509.66, in Subchapter C, Operational Requirements, detail requirements for proper facility operational standards, including administration, staffing, training, services provided, medical records, infection control, patient rights, and quality assurance. These new sections are consistent with the rules in previous Title 25, Chapter 131, Subchapter C, but with edits to remove outdated information on programs and requirements that no longer exist. Proposed new §509.41, Operational Standards, implements H.B. 1112 and H.B. 2041 to outline advertising and marketing requirements relating to insurers and health benefit plans. These changes also clarify the regulatory consequences of violating these requirements by making false, misleading, or deceptive claims. Proposed new §509.60, Patient Rights, further clarifies and simplifies marketing and advertising guidelines and implements H.B. 2041 by requiring facilities to post a notice of fees and provide a written disclosure statement that details the facility's fees and accepted health benefit plans to a patient or their legally authorized representative. Section 509.60 also implements S.B. 425 by requiring facilities to comply with HSC Chapter 324, Subchapter C.

Proposed new Subchapter D, Inspection and Investigation Procedures, composed of §§509.81 - 509.86, makes comprehensive updates to HHSC's inspection and investigation procedures for FEMC facilities to clarify provider expectations and provide greater consistency between this chapter and rules for other facility types.

Proposed new Subchapter E, Enforcement, composed of §§509.101 - 509.108, provides criteria for enforcement actions, including denial of licensure, suspension, revocation, probation, and administrative penalties. This new subchapter is consistent with the previous Title 25, Chapter 131, Subchapter B, but with edits to correct outdated titles, citations, and contact information, and increase consistency with Texas Health and Safety Code Chapter 254 and rules for other facility types.

FISCAL NOTE

Trey Wood, HHSC Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of local governments.

For the first five years that the rules will be in effect, enforcing or administering the rules does have foreseeable implications relating to revenues of state government. New applicants for FEMC facilities will pay the initial license fee of $7,410 per year for two years rather than for one year as in the current rule. The proposal, therefore, causes the licensees to pay the initial license fee of $7,410 for an additional year, rather than paying the renewal fee of $3,035 in the second year. This second-year payment at the higher fee results in additional fee income to the agency of $4,375 ($7,410 - $3,035) for each new applicant in the second year of an initial applicant's license.

HHSC lacks data to estimate how many new applicants there will be for new FEMC facility licenses in any year and therefore cannot provide an estimate of the probable new revenue from this proposal.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of HHSC employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will affect fees paid to HHSC;

(5) the proposed rules will create new rules;

(6) the proposed rules will expand and repeal existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Trey Wood has also determined that there may be an adverse economic effect on small businesses and micro-businesses as the rules are proposed.

The proposed rules require the approximately 215 FEMC facilities licensed statewide to comply with the new advertising, signage, and fee disclosure requirements outlined in Texas Health and Safety Code, Chapter 254. In addition, FEMC facilities will be required to comply with updated investigations and enforcement procedures. HHSC lacks sufficient data to estimate the number of FEMC facilities designated as small businesses or micro-businesses that will be impacted by the proposed rules as well as the adverse economic effect of the proposal. No FEMC facilities meet the definition of a rural community.

HHSC has also determined that alternative methods to achieve the purpose of the proposed rules for small businesses or micro-businesses would not be consistent with the health, safety, and environmental and economic welfare of the state in providing adequate oversight to FEMC facilities or compliance with the Texas Health and Safety Code.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT AND COSTS

Stephen Pahl, Deputy Executive Commissioner for Regulatory Services, has determined that for each year of the first five years the rules are in effect, the public benefit will be increased transparency regarding facility fees and health benefit plans, more stringent advertising guidelines, and reduced confusion regarding whether a facility is open to the public. In addition, the public will benefit from more accurate and up-to-date rule language, greater clarity regarding facility expectations during inspections and investigations, and consistency with existing statutes.

Trey Wood has also determined that for the first five years the rules are in effect, persons who are required to comply with the proposed rules may incur economic costs because the proposed rules require FEMC facilities to develop, implement, and enforce policies and procedures that ensure accurate and transparent advertising, fee disclosures, and signage specified under Texas Health and Safety Code Chapter 254. Facilities will also be required to comply with new requirements regarding facility fees, inspections, and investigations. HHSC assumes those facilities may incur costs for required documentation and staff training, as well as new advertising and disclosure requirements. HHSC lacks sufficient information to provide an estimate of costs to persons required to comply at this time.

TAKINGS IMPACT ASSESSMENT

HHSC has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to the Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st Street, Austin, Texas 78751; or emailed to HCR_PRU@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 23R024" in the subject line.

SUBCHAPTER A. GENERAL PROVISIONS

26 TAC §509.1, §509.2

STATUTORY AUTHORITY

The new rules are authorized by Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services agencies, and to implement Texas Health and Safety Code §254.101, which authorizes HHSC to adopt rules regarding FEMC facilities.

The new rules implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 254.

§509.1.Purpose.

(a) The purpose of this chapter is to implement Texas Health and Safety Code Chapter 254, referred to as "the Act" throughout this chapter, which requires freestanding emergency medical care facilities to be licensed by the Texas Health and Human Services Commission.

(b) This chapter provides:

(1) procedures for obtaining a freestanding emergency medical care facility license;

(2) minimum standards for freestanding emergency medical care facility functions and services;

(3) patient rights standards; discrimination or retaliation standards;

(4) patient transfer and other policy and protocol requirements;

(5) reporting, posting, and training requirements relating to abuse and neglect;

(6) standards for voluntary agreements;

(7) inspection and investigation procedures;

(8) enforcement standards; fire prevention and protection requirements;

(9) general safety standards;

(10) physical plant and construction requirements; and

(11) standards for preparing, submitting, reviewing, and approval of construction documents.

(c) Compliance with this chapter does not constitute release from the requirements of other applicable federal, state, or local laws, codes, rules, regulations, and ordinances. This chapter must be followed where it exceeds other requirements.

§509.2.Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Act--Texas Health and Safety Code Chapter 254, titled Freestanding Emergency Medical Care Facilities.

(2) Action plan--A written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling, or eliminating identified problem areas.

(3) Administrator--A person who is a physician, is a registered nurse, has a baccalaureate or postgraduate degree in administration or a health-related field, or has one year of administrative experience in a health-care setting.

(4) Advanced practice registered nurse (APRN)--A registered nurse authorized by the Texas Board of Nursing to practice as an advanced practice registered nurse in Texas. The term includes a nurse practitioner, nurse midwife, nurse anesthetist, and clinical nurse specialist. The term is synonymous with "advanced nurse practitioner."

(5) Adverse event--An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.

(6) Applicant--A person who seeks a freestanding emergency medical care facility license from the Texas Health and Human Services Commission (HHSC) and who is legally responsible for operation of the freestanding emergency medical care facility, whether by lease or ownership.

(7) Certified registered nurse anesthetist (CRNA)--A registered nurse who has current certification from the Council on Certification of Nurse Anesthetists and is currently authorized to practice as an advanced practice registered nurse by the Texas Board of Nursing.

(8) Change of ownership--Change in the person legally responsible for operation of the facility, whether by lease or by ownership.

(9) Designated provider--A provider of health care services selected by a health maintenance organization, a self-insured business corporation, a beneficial society, the Veterans Administration, TRICARE, a business corporation, an employee organization, a county, a public hospital, a hospital district, or any other entity to provide health care services to a patient with whom the entity has a contractual, statutory, or regulatory relationship that creates an obligation for the entity to provide the services to the patient.

(10) Disposal--Discharge, deposit, injection, dumping, spilling, leaking, or placing any solid waste or hazardous waste (containerized or uncontainerized) into or on any land or water so that solid waste or hazardous waste, or any constituent thereof, may enter the environment or be emitted into the air or discharge into any waters, including groundwaters.

(11) Emergency care--Health care services provided in a freestanding emergency medical care facility to evaluate and stabilize medical conditions of a recent onset and severity, including severe pain, that would lead a prudent layperson possessing an average knowledge of medicine and health to believe that the person's condition, sickness, or injury is of such a nature that failure to get immediate medical care could result in:

(A) placing the person's health in serious jeopardy;

(B) serious impairment to bodily functions;

(D) serious disfigurement; or

(E) in the case of a pregnant woman, serious jeopardy to the health of the woman or fetus.

(12) Facility--A freestanding emergency medical care facility.

(13) Freestanding emergency medical care facility--A facility that is structurally separate and distinct from a hospital and which receives an individual and provides emergency care as defined in this section.

(14) Freestanding emergency medical care facility administration--The administrative body of a freestanding emergency medical care facility headed by an individual who has the authority to represent the facility and who is responsible for operation of the facility according to the policies and procedures of the facility's governing body.

(15) Governing body--The governing authority of a freestanding emergency medical care facility that is responsible for a facility's organization, management, control, and operation, including appointment of the medical staff; and includes the owner or partners for a freestanding emergency medical care facility owned or operated by an individual or partners or corporation.

(16) HHSC--Texas Health and Human Services Commission.

(17) Licensed vocational nurse (LVN)--A person who is currently licensed by the Texas Board of Nursing as a licensed vocational nurse.

(18) Licensee--The person or governmental unit named in the application for issuance of a facility license.

(19) Medical director--A physician who is board certified or board eligible in emergency medicine, or board certified in primary care with a minimum of two years of emergency care experience.

(20) Medical staff--A physician or group of physicians, podiatrist or group of podiatrists, and dentist or group of dentists who by action of the governing body of a facility are privileged to work in and use the facility.

(21) Owner--One of the following persons or governmental unit that will hold, or does hold, a license issued under the Act in the person's name or the person's assumed name:

(A) a corporation;

(B) a governmental unit;

(D) an individual;

(E) a partnership, if a partnership name is stated in a written partnership agreement, or an assumed name certificate;

(F) all partners in a partnership if a partnership name is not stated in a written partnership agreement, or an assumed name certificate; or

(G) all co-owners under any other business arrangement.

(22) Patient--An individual who presents for diagnosis or treatment.

(23) Person--An individual, firm, partnership, corporation, association, or joint stock company, including a receiver, trustee, assignee, or other similar representative of such an entity.

(24) Physician--An individual licensed by the Texas Medical Board and authorized to practice medicine in the state of Texas.

(25) Physician assistant--An individual licensed as a physician assistant by the Texas State Board of Physician Assistant Examiners.

(26) Practitioner--A health care professional licensed in the state of Texas, other than a physician, podiatrist, or dentist. A practitioner shall practice in a manner consistent with their underlying practice act.

(27) Prelicensure conference--A conference held between HHSC staff and the applicant or the applicant's representative to review licensure rules and survey documents and provide consultation before the on-site licensure inspection.

(28) Premises--A building where patients receive emergency services from a freestanding emergency medical care facility.

(29) Quality assessment and performance improvement (QAPI)--An ongoing program that measures, analyzes, and tracks quality indicators related to improving health outcomes and patient care emphasizing a multidisciplinary approach. The program implements improvement plans and evaluates the implementation until resolution is achieved.

(30) Registered nurse (RN)--An individual who is currently licensed by the Texas Board of Nursing as a registered nurse.

(31) Sexual assault survivor--An individual who is a victim of a sexual assault, regardless of whether a report is made, or a conviction is obtained in the incident.

(32) Stabilize--To provide necessary medical treatment of an emergency medical condition to ensure, within reasonable medical probability, that the condition is not likely to deteriorate materially from or during the transfer of the individual from a facility.

(33) Transfer--Movement (including the discharge) of an individual outside a facility at the direction of and after personal examination and evaluation by the facility physician. Transfer does not include movement outside a facility of an individual who has been declared dead or who leaves the facility against the advice of a physician.

(34) Transfer agreement--A referral, transmission, or admission agreement with a hospital.

(35) Universal precautions--Procedures for disinfecting and sterilizing reusable medical devices and appropriate use of infection control, including hand washing, use of protective barriers, and use and disposal of needles and other sharp instruments, as those procedures are defined by the Centers for Disease Control and Prevention (CDC) of the United States Department of Health and Human Services. This term includes standard precautions as defined by CDC, which are designed to reduce the risk of transmission of bloodborne and other pathogens in healthcare facilities.

(36) Violation--Failure to comply with the Act, another statute, a rule or standard, or an order issued by the executive commissioner of HHSC or the executive commissioner's designee, adopted or enforced under the Act.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 29, 2023.

TRD-202302359

Karen Ray

Chief Counsel

Health and Human Services Commission

Earliest possible date of adoption: August 13, 2023

For further information, please call: (512) 834-4591

SUBCHAPTER B. LICENSING REQUIREMENTS

26 TAC §§509.21 - 509.30

STATUTORY AUTHORITY

The new rules implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 254.

§509.21.General.

(a) License required.

(1) Except as provided in §509.22 of this subchapter (related to Exemptions from Licensure), a person may not establish or operate a freestanding emergency medical care facility in this state without a license issued by the Texas Health and Human Services Commission (HHSC).

(2) A facility or person shall not hold itself out to the public as a freestanding emergency medical care facility or advertise, market, or otherwise promote the services using the terms "emergency," "ER," or any similar term that would give the impression that the facility or person is providing emergency care.

(3) An applicant shall submit a license application in accordance with §509.24 of this subchapter (relating to Application and Issuance of Initial License). The applicant shall retain copies of all application documents submitted to HHSC.

(b) Compliance requirements. A facility shall comply with the provisions of the Act and this chapter during the licensing period.

(1) Each separate facility location shall have a separate license.

(2) HHSC issues a facility license for the premises and person or governmental unit named in the application.

(3) A facility shall not have more than one health facility license for the same physical address. The premises of a facility license shall be separated from any other occupancy or licensed health facility by a minimum of a one-hour fire rated wall.

(4) A facility license authorizes only emergency care services and procedures that are related to providing emergency care.

(d) License display requirements. A facility shall prominently and conspicuously display the facility license in a public area of the licensed premises that is readily visible to patients, employees, and visitors.

(e) License alterations prohibited. A facility license shall not be altered.

(f) License transfer prohibited. A facility license shall not be transferred or assigned. The facility shall comply with the provisions of §509.27 of this subchapter (relating to Change of Ownership) in the event of a change in the ownership of a facility.

(g) Changes that affect the license.

(1) A facility shall notify HHSC in writing before:

(A) any construction, renovation, or modification of the facility buildings as described in 25 TAC Chapter 131, Subchapter G (relating to Physical Plant and Construction Requirements); or

(B) facility operations cease.

(2) A facility shall notify HHSC in writing not later than the third calendar day after:

(A) a facility modifies its evacuation or smoke compartment relocation plans in accordance with the requirements of NFPA 101: Life Safety Code (2018); or

(B) a facility's fire alarm system or sprinkler system becomes non-operational.

(3) A facility shall notify HHSC in writing not later than the 10th calendar day after the effective date of:

(A) a change in certification or accreditation status; or

(B) a change in facility name, mailing address, telephone number, or administrator.

(4) A facility that becomes inactive or closes shall meet the requirements in §509.26 of this subchapter (relating to Inactive Status and Closure).

§509.22.Exemptions from Licensure.

The following facilities are not required to be licensed under this chapter:

(1) an office or clinic owned and operated by a manufacturing facility solely for the purposes of treating its employees and contractors;

(2) a temporary emergency clinic in a disaster area;

(3) an office or clinic of a licensed physician, dentist, optometrist, or podiatrist;

(4) a licensed nursing home;

(5) a licensed hospital;

(6) a hospital that is owned and operated by this state;

(7) a facility located within or connected to a licensed hospital or a hospital that is owned and operated by this state;

(8) a facility that is owned or operated by a licensed hospital or a hospital that is owned and operated by this state and is:

(A) surveyed as a service of the hospital by an organization that has been granted deeming authority as a national accreditation program for hospitals by the Centers for Medicare and Medicaid Services (CMS); or

(B) granted provider-based status by CMS; or

(9) a licensed ambulatory surgical center.

§509.23.Unlicensed Facilities.

(a) If the Texas Health and Human Services Commission (HHSC) has reason to believe that a person or facility may be providing emergency medical care services as defined in this chapter without a license, HHSC will notify the person or facility in writing by certified mail, return receipt requested. Not later than 20 calendar days after the date the person or facility receives the notice, the person or facility shall submit to HHSC either:

(1) an application for a license and the nonrefundable license fee;

(2) a claim for exemption under §509.22 of this subchapter (relating to Exemptions from Licensure); or

(3) documentation sufficient to establish that freestanding emergency medical care services are not being provided, including a notarized statement that freestanding emergency medical care services are not being provided and listing the types of services that are provided.

(b) If a person or facility submits an application for a license, HHSC will process the application in accordance with §509.25 of this subchapter (relating to Application and Issuance of Initial License).

(c) If the person or facility submits a claim for exemption, HHSC shall evaluate the claim for exemption and notify the person or facility in writing of the proposed decision within 30 calendar days following receipt of the claim for exemption.

(d) If the person or facility submits sufficient documentation, under subsection (a)(3) of this section, to establish that the facility does not provide freestanding emergency medical services, HHSC shall notify the person or facility in writing that no license is required not later than 30 calendar days after HHSC receives the documentation.

(e) If HHSC determines the documentation submitted under subsection (a)(3) of this section is insufficient, HHSC shall notify the person or facility in writing not later than 30 calendar days after HHSC received the documentation. The person or facility shall have the opportunity to respond not later than 10 calendar days after the date the facility receives the notice. Not later than 10 calendar days after the date HHSC receives the facility's response, HHSC shall notify the person or facility in writing of HHSC's determination.

§509.24.Application and Issuance of Initial License.

(a) All first-time applications for licensing are applications for an initial license, including applications from unlicensed operational facilities and licensed facilities for which a change of ownership or relocation is anticipated.

(b) The applicant shall submit the completed application, the information required in subsection (d) of this section, and the nonrefundable license fee to the Texas Health and Human Services Commission (HHSC) 90 days before the projected opening date of the facility.

(1) the name, address, and social security number of the owner or sole proprietor, if the owner of the facility is a sole proprietor;

(2) the name, address, and social security number of each general partner who is an individual, if the facility is a partnership;

(3) the name, address, and social security number of any individual who has an ownership interest of more than 25 percent in the corporation, if the facility is a corporation;

(4) the name, medical license number, and medical license expiration date of any physician licensed by the Texas Medical Board who has a financial interest in the facility or in any entity that has an ownership interest in the facility;

(5) the name, medical license number, and medical license expiration date of the medical chief of staff;

(6) the name, nursing license number, and nursing license expiration date of the director of nursing;

(7) affirmation that at least one physician licensed in the state of Texas and at least one registered nurse licensed in the state of Texas will be on site during all hours of operation;

(8) information concerning the applicant and the applicant's affiliates and managers, as applicable:

(A) denial, suspension, probation, or revocation of a facility license in any state or any other enforcement action, such as court civil or criminal action in any state;

(B) surrendering a license before expiration of the license or allowing a license to expire in lieu of HHSC proceeding with enforcement action;

(D) Medicare or Medicaid sanctions or penalties relating to operation of a health care facility or home and community support services agency;

(E) operation of a health care facility or home and community support services agency that has been decertified or terminated from participation in any state under Medicare or Medicaid; or

(F) debarment, exclusion, or contract cancellation in any state from Medicare or Medicaid;

(9) for the two-year period preceding the application date, information concerning the applicant and the applicant's affiliates and managers, as applicable:

(A) federal or state (any state) criminal misdemeanor arrests or convictions;

(B) federal, state (any state), or local tax liens;

(D) eviction involving any property or space used as a health care facility in any state;

(E) injunctive orders from any court; or

(F) unresolved final federal or state (any state) Medicare or Medicaid audit exceptions;

(10) the number of emergency treatment stations;

(11) a copy of the facility's patient transfer policy and procedure for the immediate transfer to a hospital of patients requiring emergency care beyond the capabilities of the facility developed in accordance with §509.65 of this chapter (relating to Patient Transfer Policy) and signed by the chairman and the secretary of the governing body that attests the date the policy was adopted by the governing body and its effective date;

(12) a copy of the facility's memorandum of transfer form, which contains at a minimum the information described in §509.65 of this chapter;

(13) a copy of a written agreement the facility has with a hospital, which provides for the prompt transfer to and the admission by the hospital of any patient when services are needed but are unavailable or beyond the capabilities of the facility in accordance with §509.66 of this chapter (relating to Patient Transfer Agreements); and

(14) a copy of a passing fire inspection report indicating approval by the local fire authority in whose jurisdiction the facility is based that is dated no earlier than one year before the opening date of the facility.

(d) The address provided on the application shall be the physical location at which the facility is or will be operating.

(e) Upon receipt of the application, HHSC shall review the application to determine whether it is complete. If HHSC determines that the application is not complete, HHSC shall notify the facility in writing.

(f) The applicant or the applicant's representative shall attend a prelicensure conference at the office designated by HHSC. HHSC may waive the prelicensure conference requirement.

(g) After the facility has participated in a prelicensure conference or the prelicensure conference has been waived at HHSC's discretion, the facility has received an approved architectural inspection conducted by HHSC, and HHSC has determined the facility is in compliance with subsections (c) - (e) of this section, HHSC shall issue a license to the facility to provide freestanding emergency medical care services in accordance with this chapter.

(h) The license shall be effective on the date the facility is determined to be in compliance with subsections (c) - (g) of this section.

(i) The license expires on the last day of the 24th month after issuance.

(j) If an applicant decides not to continue the application process for a license, the applicant may withdraw its application. The applicant shall submit to HHSC a written request to withdraw. HHSC shall acknowledge receipt of the request to withdraw.

(k) If the applicant does not complete all requirements of subsections (b) - (d) and (f) of this section within six months after the date HHSC's health care facility licensing unit receives confirmation that HHSC received the application and payment, HHSC will withdraw the application. Any fee paid for a withdrawn application is nonrefundable, as indicated by §509.30(d) of this subchapter (relating to Fees).

(l) During the initial licensing period, HHSC shall conduct an inspection of the facility to ascertain compliance with the provisions of the Act and this chapter.

(1) The facility shall request HHSC conduct an on-site inspection after the facility provides services to at least one patient.

(2) The facility shall be providing services at the time of the inspection.

§509.25.Application and Issuance of Renewal License.

(a) The Texas Health and Human Services Commission (HHSC) may send written notice of expiration of a license to a facility no later than 60 calendar days before the expiration date. If the applicant has not received notice, it is the duty of the applicant to notify HHSC and request a renewal application.

(b) The facility shall submit to HHSC no later than 30 calendar days before the expiration date of the license:

(1) a completed renewal application form;

(2) a nonrefundable license fee;

(3) a copy of a passing fire inspection report conducted within the last 12 months and one from the year prior indicating approval by the local fire authority in whose jurisdiction the facility is based, as HHSC requires annual fire safety inspections for a facility's continued licensure status; and

(4) if the facility is accredited by the Joint Commission or other accrediting organization, documented evidence of current accreditation status.

(c) HHSC shall issue a renewal license to a facility that submits a renewal application in accordance with subsection (b) of this section and meets the minimum standards for a license set forth in this chapter.

(d) Renewal licenses shall be valid for two years from the previous expiration date.

(e) If a facility fails to timely submit a complete application and fee in accordance with subsection (b) of this section, HHSC shall notify the facility that the facility shall cease providing freestanding emergency medical care (FEMC) services. If the facility provides HHSC with sufficient evidence the facility submitted a complete application and fee in a timely manner and the facility adhered to all required dates, HHSC will dismiss the cessation notice prohibiting the facility from providing FEMC services. If the facility does not provide sufficient evidence, the facility shall immediately return the license to HHSC within 30 days of HHSC's notification.

(f) If a facility does not correct a deficiency in the renewal application within 10 business days after the date HHSC notifies the facility of the deficiency, HHSC may deny the renewal application. Any fee paid for a denied renewal application is nonrefundable, as indicated by §509.30(d) of this subchapter (relating to Fees).

(g) If a license expires and a facility wishes to provide FEMC services after the expiration date of the license, the facility shall reapply for a license under §509.24 of this subchapter (relating to Application and Issuance of Initial License).

§509.26.Inactive Status and Closure.

(a) A facility that does not provide services under its license for more than five calendar days shall inform the Texas Health and Human Services Commission (HHSC), and HHSC will change the status of the facility license to inactive.

(1) To be eligible for inactive status, a facility must be in good standing with no pending enforcement action or investigation.

(2) The licensee is responsible for any license renewal requirements or fees, and for proper maintenance of patient records, while the license is inactive.

(3) A license may not remain inactive for more than 60 calendar days.

(4) To reactivate the license, the facility must inform HHSC no later than 60 calendar days after the facility stopped providing services under its license.

(5) A facility that does not reactivate its license by the 60th calendar day after it stopped providing services has constructively surrendered its license, and HHSC will consider the facility closed.

(b) A facility shall notify HHSC in writing before closure of the facility.

(1) The facility shall dispose of medical records in accordance with §509.54 of this chapter (relating to Medical Records).

(2) The facility shall appropriately discharge or transfer all patients before the facility closes.

(3) A license becomes invalid when a facility closes. The facility shall return the licensure certificate to HHSC not later than 30 calendar days after the facility closes.

(c) A facility that closes, or for which a license issued under this chapter expires or is suspended or revoked, shall immediately remove or cause to be removed any signs within view of the general public indicating that the facility is in operation as required under Texas Health and Safety Code §254.158 (relating to Removal of Signs).

§509.27.Change of Ownership.

(a) When a facility plans to change its ownership, the new owner shall submit:

(1) an application for an initial license and nonrefundable fee to the Texas Health and Human Services Commission (HHSC) no later than 30 calendar days before the date of the change of ownership in accordance with §509.24 of this subchapter (relating to Application and Issuance of Initial License); and

(2) notwithstanding §509.24(c)(14) of this subchapter, a copy of a passing fire inspection report conducted within the last 12 months and one from the year prior indicating approval by the local fire authority in whose jurisdiction the facility is based. Annual fire safety inspections are required for continued licensure status.

(b) In addition to the documents required in §509.24 of this subchapter, the applicant shall submit a copy of the signed bill of sale or lease agreement that reflects the effective date of the change of ownership.

(c) The applicant is not required to submit a transfer agreement that HHSC has previously approved if the applicant notifies HHSC in writing that it has adopted the transfer agreement.

(d) A facility is not required to submit an application for change of ownership if the facility changes only its name. If a facility changes its name, the facility must notify HHSC no later than 10 calendar days after the effective date of the change.

(e) For a change of ownership, HHSC may waive the initial licensure on-site health inspection required by §509.24(l) of this subchapter and the initial on-site construction inspection required by 25 TAC Chapter 131, Subchapter G (relating to Physical Plant and Construction Requirements).

(f) If the applicant does not complete all requirements of subsection (a) and (b) of this section within six months after the date HHSC's health facility licensing unit receives confirmation that HHSC received the application and payment, HHSC will withdraw the application. Any fee paid for a withdrawn application is nonrefundable, as indicated by §509.30(d) of this subchapter (relating to Fees).

(g) When the new owner has complied with the provisions of §509.24 of this subchapter, HHSC shall issue a license that is effective as of the date of the change of ownership.

(h) HHSC shall set the expiration date of the license in accordance with §509.24 of this subchapter.

(i) The previous owner's license becomes void as of the effective date of the new owner's license.

§509.28.Conditions of Licensure.

(a) A facility license is issued only for the premises and person or governmental unit named on the application.

(b) A facility license is issued for a single physical location and shall not include multiple buildings or offsite locations.

(c) A license shall not be transferred or assigned from one person or governmental unit to another person or governmental unit.

(d) A license shall not be transferred from one facility location to another.

(e) If a facility is relocating, the facility shall complete and submit a license application and nonrefundable fee no later than 30 calendar days before facility relocation. The Texas Health and Human Services Commission (HHSC) shall process the application in accordance with §509.24 of this subchapter (relating to Application and Issuance of Initial License). An initial license for the relocated facility is effective on the date the relocation occurred. The previous license is void on the date of relocation.

(f) A facility that changes its telephone number shall send HHSC written notice of the change no later than 30 calendar days after the number has changed.

(g) If a facility's name changes, the facility shall notify HHSC in writing no later than 30 calendar days after the effective date of the name change.

§509.29.Time Periods for Processing and Issuing Licenses.

(a) The date a license application is received is the date the application reaches the Texas Health and Human Services Commission (HHSC).

(b) An application for an initial license is complete when HHSC has received the application fee and received, reviewed, and found acceptable the information described in §509.24 of this subchapter (relating to Application and Issuance of Initial License).

(c) An application for a renewal license is complete when HHSC has received the application fee and received, reviewed, and found acceptable the information described in §509.25 of this subchapter (relating to Application and Issuance of Renewal License).

(d) HHSC shall process an application from an applicant for an initial license or a facility for a renewal license in accordance with the following time periods.

(1) The first time period begins on the date HHSC receives the complete application and ends on the date HHSC issues the license. The first time period is 45 calendar days.

(2) If HHSC receives an incomplete application, the first time period ends on the date HHSC issues a written notice to the applicant or facility that the application is incomplete. The written notice shall describe the specific information HHSC requires before HHSC considers the application complete.

(3) For incomplete applications, the second time period begins on the date HHSC receives the last item necessary to complete the application and ends on the date HHSC issues the license. The second time period is 45 calendar days.

(e) In the event HHSC does not process the application in the time periods stated in subsection (d) of this section, the applicant has the right to request that HHSC reimburse in full the fee paid in that particular application process. If HHSC does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, HHSC shall deny the request.

(f) Good cause for exceeding the period established is considered to exist if:

(1) the number of applications for licenses to be processed exceeds by 15 percent or more the number processed in the same calendar quarter the preceding year;

(2) another public or private entity used in the application process caused the delay; or

(3) other conditions existed giving good cause for exceeding the established periods.

(g) If the request for reimbursement as authorized by subsection (e) of this section is denied, the applicant may then appeal to the HHSC Executive Commissioner (executive commissioner) for a resolution of the dispute. The applicant shall give written notice to the executive commissioner requesting reimbursement of the fee paid because the application was not processed within the established time period. HHSC shall submit a written report of the facts related to the processing of the application and good cause for exceeding the established time periods. HHSC shall make the final decision and provide written notification of the decision to the applicant and HHSC.

(h) If a hearing is proposed during the processing of the application, the hearing shall be conducted under Texas Government Code Chapter 2001 (relating to Administrative Procedure); 1 TAC Chapter 357, Subchapter I (relating to Hearings Under the Administrative Procedure Act); and 1 TAC Chapter 155 (relating to Rules of Procedure).

§509.30.Fees.

(a) The fee for an initial license (includes change of ownership or relocation) is $14,820. The license term is two years.

(b) The fee for a renewal license is $6,070. The license term is two years.

(d) Fees paid to the Texas Health and Human Services Commission (HHSC) are not refundable, except as indicated in §509.29 of this subchapter (relating to Time Periods for Processing and Issuing Licenses).

(e) All fees shall be paid to HHSC.

(f) HHSC collects subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online, in accordance with Texas Government Code §2054.111 (relating to Use of State Electronic Internet Portal Project) and §2054.252 (State Electronic Internet Portal Project).

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 29, 2023.

TRD-202302360

Karen Ray

Chief Counsel

Health and Human Services Commission

Earliest possible date of adoption: August 13, 2023

For further information, please call: (512) 834-4591

SUBCHAPTER C. OPERATIONAL REQUIREMENTS

26 TAC §§509.41 - 509.66

STATUTORY AUTHORITY

The new rules implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 254.

§509.41.Operational Standards.

(a) A facility shall have an identified governing body fully responsible for organization, management, control, and operation of the facility, including the appointment of the facility's medical director. The medical director shall be board certified or board eligible in emergency medicine, or board certified in primary care with at least two years emergency care experience.

(b) The governing body shall adopt, implement, and enforce written policies and procedures for the total operation and all services provided by the facility.

(c) The governing body is responsible for all services furnished in the facility, whether furnished directly or under contract. The governing body shall ensure services are provided in a safe and effective manner that permits the facility to comply with all applicable rules and standards.

(d) The governing body shall ensure the medical staff has on file current written bylaws, rules, and regulations that are adopted, implemented, and enforced.

(e) The governing body shall disclose all owners of the facility to the Texas Health and Human Services Commission (HHSC).

(f) The governing body shall meet at least annually and keep minutes or other records necessary for orderly conduct of the facility. Each meeting held by the facility governing body shall be a separate meeting with separate minutes from any other governing body meeting.

(g) If the governing body elects, appoints, or employs officers and administrators to carry out its directives, the governing body shall define the authority, responsibility, and functions of all such positions.

(h) The governing body shall develop a process for appointing or reappointing medical staff, and for assigning or curtailing medical privileges.

(i) The governing body shall provide (in a manner consistent with state law and based on evidence of education, training, and current competence) for the initial appointment, reappointment, and assignment or curtailment of privileges and practice for non-physician health care personnel and practitioners.

(j) The governing body shall encourage personnel to participate in continuing education that is relevant to their responsibilities within the facility.

(k) The governing body shall adopt, implement, and enforce written policies to ensure compliance with applicable state and federal laws.

(l) In accordance with Texas Health and Safety Code §254.157 (relating to Certain Advertising Prohibited), a facility may not advertise or hold itself out as a network provider, including by stating that the facility "takes" or "accepts" any insurer, health maintenance organization, health benefit plan, or health benefit plan network, unless the facility is a network provider of a health benefit plan issuer.

(m) A facility may not post the name or logo of a health benefit plan issuer in any signage or marketing materials if the facility is an out-of-network provider for all of the issuer's health benefit plans.

(n) A facility shall assess, and the governing body shall review, patient satisfaction with services and environment no less than annually.

§509.42.Governing Body Responsibilities.

The governing body shall address and is fully responsible, either directly or by appropriate professional delegation, for operation and performance of the facility. Governing body responsibilities include:

(1) determining the mission, goals, and objectives of the facility;

(2) ensuring that facilities and personnel are adequate and appropriate to carry out the mission;

(3) ensuring a physical environment that protects the health and safety of patients, personnel, and the public;

(4) establishing an organizational structure and specifying functional relationships among the various components of the facility;

(5) adopting, implementing, and enforcing bylaws or similar rules and regulations for the orderly development and management of the facility;

(6) adopting, implementing, and enforcing policies or procedures necessary for orderly conduct of the facility;

(7) reviewing and approving the facility's training program for staff;

(8) ensuring that all equipment used by facility staff or patients is properly used and maintained per manufacturer recommendations;

(9) adopting, implementing, and enforcing policies or procedures related to emergency planning and disaster preparedness, including reviewing the facility's disaster preparedness plan at least annually;

(10) ensuring there is a quality assessment and performance improvement (QAPI) program to evaluate the provision of patient care, including quarterly review and monitoring of QAPI activities;

(11) reviewing legal and ethical matters concerning the facility and its staff, when necessary, and responding appropriately;

(12) maintaining effective communication throughout the facility;

(13) establishing a system of financial management and accountability that includes an audit or financial review appropriate to the facility;

(14) adopting, implementing, and enforcing policies for provision of radiological services;

(15) adopting, implementing, and enforcing policies for provision of laboratory services;

(16) adopting, implementing, and enforcing policies for provision of pharmacy services;

(17) adopting, implementing, and enforcing policies for collection, processing, maintenance, storage, retrieval, authentication, and distribution of patient medical records and reports;

(18) adopting, implementing, and enforcing a policy on the rights of patients and complying with all state and federal patient rights requirements;

(19) adopting, implementing, and enforcing policies for provision of an effective procedure for the immediate transfer to a licensed hospital of patients requiring emergency care beyond the capabilities of the facility, including a transfer agreement with a hospital licensed in this state in accordance with §509.66 of this subchapter (relating to Patient Transfer Agreements);

(20) adopting, implementing, and enforcing policies for all individuals that arrive at the facility to ensure they are provided an appropriate medical screening examination within the capability of the facility, including ancillary services routinely available to determine whether or not the individual needs emergency care as defined in §509.2 of this chapter (relating to Definitions), and that if emergency care is determined to be needed, the facility shall provide any necessary stabilizing treatment or arrange an appropriate transfer the individual as defined in §509.65 of this subchapter (relating to Patient Transfer Policy);

(21) adopting, implementing, and enforcing protocols to be used in determining death and for filing autopsy reports that comply with Texas Health and Safety Code Chapter 671 (relating to Determination of Death and Autopsy Reports);

(22) approving all major contracts or arrangements affecting the medical care provided under its auspices, including those concerning:

(A) services of physicians and practitioners;

(B) use of external laboratories; and

(C) an effective procedure for obtaining emergency laboratory, radiology, and pharmaceutical services when these services are not immediately available due to system failure;

(23) formulating long-range plans in accordance with the mission, goals, and objectives of the facility;

(24) operating the facility without limitation because of color, race, age, sex, religion, national origin, or disability;

(25) ensuring that all marketing and advertising concerning the facility does not imply that it provides care or services that the facility is not capable of providing; and

(26) developing a system of risk management appropriate to the facility, including:

(A) periodic review of all litigation involving the facility, its staff, physicians, and practitioners regarding activities in the facility;

(B) periodic review of all incidents reported by staff and patients;

(D) evaluation of patient complaints.

§509.43.Administration.

(a) The facility administration shall adopt, implement, and enforce administrative policies, procedures, and controls to ensure orderly and efficient management of the facility. Administrative responsibilities shall include:

(1) enforcing policies delegated by the governing body;

(2) employing qualified management personnel;

(3) long- and short-range planning for the needs of the facility, as determined by the governing body;

(4) using methods of communicating and reporting, designed to ensure orderly flow of information within the facility;

(5) controlling purchase, maintenance, and distribution of the equipment, materials, and facilities of the facility;

(6) establishing lines of authority, accountability, and supervision of personnel;

(7) establishing controls relating to custody of the official documents of the facility; and

(8) maintaining confidentiality, security, and physical safety of data on patients and staff.

(b) The facility administration shall adopt, implement, and enforce personnel policies to facilitate attainment of the mission, goals, and objectives of the facility. Personnel policies shall:

(1) define and delineate functional responsibilities and authority;

(2) require employment of personnel with qualifications commensurate with job responsibilities and authority, including appropriate licensure or certification;

(3) require documented periodic appraisal of each person's job performance;

(4) specify responsibilities and privileges of employment;

(5) be made known to employees at the time of employment; and

(6) provide and document adequate orientation and training to familiarize all personnel with the facility's policies, procedures, equipment, and facilities.

(c) A facility shall adopt, implement, and enforce personnel policies that address and are relevant to all employees and contractors.

(d) A facility shall develop appropriate job descriptions for each employee position.

§509.44.Medical Director.

(a) The medical director shall be on-site at the facility when necessary to fulfill the responsibilities of the position, as described by this chapter and the governing body.

(b) Notwithstanding subsection (a) of this section, each facility's medical director shall be on-site at the facility for at least 12 hours per month.

(1) organizing the emergency services to be provided at the facility;

(2) supervising and overseeing the infection control program and quality assessment and performance improvement (QAPI) program; and

(3) regularly attending meetings of the infection control program and QAPI program.

(d) The medical director shall have the authority to contract with outside persons for performance of the facility's peer review activities, as necessary.

§509.45.Medical Staff.

(a) The medical staff shall periodically conduct appraisals of its members according to medical staff bylaws.

(b) The medical staff shall examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidate.

(c) The medical staff shall be well-organized and accountable to the governing body for the quality of the medical care provided to patients.

(1) The medical staff shall be organized in a manner approved by the governing body.

(2) If the medical staff has an executive committee, the members of the committee shall be doctors of medicine or osteopathy.

(3) The facility shall maintain records of medical staff meetings.

(4) The governing body shall assign responsibility for organization and conduct of the medical staff only to an individual physician.

(5) Each medical staff member shall sign a statement signifying they will abide by medical staff and facility policies.

(d) The medical staff shall adopt, implement, and enforce written bylaws, rules, and regulations to carry out its responsibilities. The bylaws shall:

(1) be approved by the governing body;

(2) include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, consultant);

(3) describe the organization of the medical staff;

(4) describe the qualifications a candidate must meet for the medical staff to recommend the governing body appoint the candidate; and

(5) include criteria for determining the privileges to be granted and a procedure for applying the criteria to individuals requesting privileges. To be privileged, a physician must have at least one year of experience in emergency services, and current certification in advanced cardiac life support, pediatric advanced life support, and advanced trauma life support.

§509.46.Facility Staffing and Training.

(a) A facility shall have personnel qualified to operate emergency equipment and to provide emergency care to patients that is on site and available at all times.

(b) A facility shall comply with the following nursing services staffing and training requirements.

(1) There shall be an organized nursing service under the direction of a qualified registered nurse (RN). The facility shall be staffed to ensure the nursing needs of all patients are met.

(2) There shall be a written plan of administrative authority for all nursing services with responsibilities and duties of each category of nursing personnel delineated and a written job description for each category. The scope of nursing services shall be limited to nursing care rendered to patients as authorized by Texas Occupations Code Chapter 301 (relating to Nurses).

(A) The responsible individual for nursing services shall be a qualified RN whose responsibility and authority shall be clearly defined and shall include supervision of both personnel performance and patient care.

(B) There shall be a written delineation of functions, qualifications, and patient care responsibilities for all categories of nursing personnel.

(3) There shall be an adequate number of RNs on duty to meet minimum staff requirements, including supervisory and staff RNs, to ensure the immediate availability of an RN for emergency care or for any patient when needed.

(4) There shall be other nursing personnel in sufficient numbers to provide nursing care not requiring the service of an RN. An RN shall assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the preparation and qualifications of the nursing staff available.

(5) An RN qualified, at a minimum, with current certification in advanced cardiac life support and pediatric advanced life support shall be on duty at the facility at all times whenever patients are present in the facility.

(6) All direct care staff members shall maintain current certification and competency in basic cardiac life support.

(7) The facility shall establish a nursing peer review committee to conduct nursing peer review, to the extent required by Texas Occupations Code Chapter 303 (relating to Nursing Peer Review).

(c) In addition to meeting the requirements for nursing staff under subsection (b) of this section, a facility shall comply with the following minimum staffing requirements:

(1) A facility that provides only topical anesthesia, local anesthesia, or minimal sedation shall have a second individual, who is trained and currently certified in basic cardiac life support, on duty at the facility until all patients have been discharged from the facility.

(2) A facility that provides moderate sedation or analgesia shall have the following additional staff:

(A) a second individual, who is trained and currently certified in basic cardiac life support, on duty at the facility until all patients have been discharged from the facility; and

(B) an individual trained and currently certified in advanced cardiac life support and pediatric advanced life support, until all patients have been discharged.

(3) A facility that provides deep sedation or analgesia or regional anesthesia shall have the following additional staff:

(A) a second individual, who is trained and currently certified in basic cardiac life support, on duty at the facility until all patients have been discharged from the facility; and

(B) an individual who is trained and currently certified in advanced cardiac life support and pediatric advanced life support, on duty and sufficiently free of other duties to enable the individual to respond rapidly to emergency situations, until all patients have been discharged.

§509.47.Emergency Services.

(a) A facility shall provide to each patient, without regard to the individual's ability to pay, an appropriate medical screening, examination, and stabilization within the facility's capability, including ancillary services routinely available to the facility, to determine whether an emergency medical condition exists, and any necessary stabilizing treatment.

(b) The organization of emergency services shall be appropriate to the scope of the services offered. The services shall be organized under the direction of a qualified physician member of the medical staff who is the medical director or clinical director.

(c) A facility shall maintain patient medical records for all emergency patients. The medical records shall contain patient identification, complaints, name of physician, name of nurse, time admitted to the emergency suite, treatment, time discharged, and disposition.

(d) A facility shall comply with the following personnel requirements.

(1) There shall be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility.

(2) As determined by the medical staff, there must always be at least one person qualified and at least one nurse with current advanced cardiac life support and pediatric advanced life support certification on duty and on-site a to initiate immediate appropriate lifesaving measures.

(3) Qualified personnel shall always be physically present in the emergency treatment area.

(4) One or more physicians shall always be on-site during facility hours of operation.

(5) A facility shall maintain schedules, names, and telephone numbers of all physicians and others on emergency call duty, including alternates. The facility shall retain the schedules for at least one year.

(e) Adequate age-appropriate supplies and equipment shall be available and in readiness for use. Equipment and supplies shall be available for the administration of intravenous medications as well as facilities for the control of bleeding and emergency splinting of fractures. The facility shall periodically test the emergency equipment according to its policy.

(f) Age-appropriate emergency equipment and supplies shall include:

(1) emergency call system;

(2) oxygen;

(3) mechanical ventilatory assistance equipment, including airways, manual breathing bag, and mask;

(4) cardiac defibrillator;

(5) cardiac monitoring equipment;

(6) laryngoscopes and endotracheal tubes;

(7) suction equipment;

(8) emergency drugs and supplies specified by the medical staff;

(9) stabilization devices for cervical injuries;

(10) blood pressure monitoring equipment; and

(11) pulse oximeter or similar medical device to measure blood oxygenation.

(g) A facility shall participate in the local Emergency Medical Service (EMS) system, based on the facility's capabilities and capacity, and the locale's existing EMS plan and protocols.

(h) A facility shall comply with the following emergency services requirements for sexual assault survivors.

(1) This subsection does not affect the duty of a facility to comply with subsection (a) of this section.

(2) The facility shall develop, implement, and enforce policies and procedures to ensure that after a sexual assault survivor presents to the facility following a sexual assault, the facility shall provide the care specified under Texas Health and Safety Code Chapter 323, Subchapter A (relating to Emergency Services for Survivors of Sexual Assault).

§509.48.Anesthesia.

(a) If a facility furnishes anesthesia services, the facility shall provide these services in a well-organized manner under the medical direction of a physician approved by the governing body and qualified in accordance with Texas Occupations Code Title 3, Subtitle B (relating to Physicians) and Texas Occupations Code Chapter 301 (relating to Nurses), as appropriate.

(b) A facility that furnishes anesthesia services shall comply with Texas Occupations Code Chapter 162, Subchapter C (relating to Anesthesia in Outpatient Setting), unless the facility is exempt under Texas Occupations Code §162.103 (relating to Applicability).

(d) Anesthesia services provided in the facility shall be limited to those that are recommended by the medical staff and approved by the governing body, which may include the following.

(1) Topical anesthesia--An anesthetic agent applied directly or by spray to the skin or mucous membranes, intended to produce transient and reversible loss of sensation to the circumscribed area.

(2) Local anesthesia--Administering an agent that produces a transient and reversible loss of sensation to a circumscribed portion of the body.

(3) Regional anesthesia--Anesthetic injected around a single nerve, a network of nerves, or vein that serves the area involved in a surgical procedure to block pain.

(4) Minimal sedation (anxiolysis)--A drug-induced state during which patients respond normally to oral commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

(5) Moderate sedation or analgesia ("conscious sedation")--A drug-induced depression of consciousness during which patients respond purposefully to oral commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. (Reflex withdrawal from a painful stimulus is not considered a purposeful response.)

(6) Deep sedation or analgesia--A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. (Reflex withdrawal from a painful stimulus is not considered a purposeful response.)

(e) The medical staff shall develop written policies and practice guidelines for the anesthesia service, which the governing body shall adopt, implement, and enforce. The policies and guidelines shall include consideration of the applicable practice standards and guidelines of the American Society of Anesthesiologists, the American Association of Nurse Anesthetists, and the licensing rules and standards applicable to those categories of licensed professionals qualified to administer anesthesia.

(f) Only personnel who have been approved by the facility to provide anesthesia services shall administer anesthesia. All approvals or delegations of anesthesia services as authorized by law shall be documented and include the training, experience, and qualifications of the person who provided the service. A qualified registered nurse (RN) who is not a certified registered nurse anesthetist (CRNA) may, in accordance with the orders of the physician or CRNA, administer topical anesthesia, local anesthesia, minimal sedation and moderate sedation, in accordance with all applicable rules, polices, directives, and guidelines issued by the Texas Board of Nursing. When an RN who is not a CRNA administers sedation, as permitted in this paragraph, the facility shall:

(1) verify the RN has the requisite training, education, and experience;

(2) maintain documentation to support that the RN has demonstrated competency in administering sedation;

(3) with input from the facility's qualified anesthesia providers, develop, implement, and enforce detailed written policies and procedures to guide the RN; and

(4) ensure that, when administering sedation during a procedure, the RN has no other duties except to monitor the patient.

(g) Anesthesia shall not be administered unless the physician has evaluated the patient immediately before the procedure to assess the risk of the anesthesia and of the procedure to be performed.

(h) A patient who has received anesthesia shall be evaluated for proper anesthesia recovery by the physician, or the person administering the anesthesia, before discharge using criteria approved by the medical staff.

(i) A patient shall be evaluated immediately before leaving the facility by a physician, the person administering the anesthesia, or an RN acting in accordance with physician's orders and written policies, procedures, and criteria developed by the medical staff.

(j) Emergency equipment and supplies appropriate for the type of anesthesia services provided shall always be maintained and accessible to staff.

(k) All facilities shall provide at least the following functioning equipment and supplies:

(1) suctioning equipment, including a source of suction and suction catheters in appropriate sizes for the population being served;

(2) a source of compressed oxygen;

(3) basic airway management equipment, including oral and nasal airways, face masks, and self-inflating breathing bag valve set;

(4) blood pressure monitoring equipment; and

(5) emergency medications specified by the medical staff and appropriate to the type of procedures and anesthesia services provided by the facility.

(l) In addition to the equipment and supplies required under subsection (k) of this section, a facility that provides moderate sedation/analgesia, deep sedation/analgesia, or regional analgesia shall provide:

(1) intravenous equipment, including catheters, tubing, fluids, dressing supplies, and appropriately sized needles and syringes;

(2) advanced airway management equipment, including laryngoscopes and an assortment of blades, endotracheal tubes, and stylets in appropriate sizes for the population being served;

(3) a mechanism for monitoring blood oxygenation, such as pulse oximetry;

(4) electrocardiographic monitoring equipment;

(5) cardiac defibrillator; and

(6) pharmacologic antagonists, as specified by the medical staff and appropriate to the type of anesthesia services provided.

§509.49.Laboratory and Pathology Services.

(a) A facility shall maintain directly, or have immediately available on the premises, adequate laboratory services to meet the needs of its patients.

(b) Laboratory services shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in accordance with the requirements specified in Code of Federal Regulations, Title 42 (42 CFR), Part 493 (relating to Laboratory Requirements). CLIA 1988 applies to all facilities with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment, or for health assessment.

(c) A facility shall ensure that all laboratory services provided to its patients through a contractual agreement are performed in a facility certified in the appropriate specialties and subspecialties of service in accordance with the requirements specified in 42 CFR Part 493 to comply with CLIA 1988.

(d) Emergency laboratory services shall be available on the premises during hours of operation, including:

(1) assays for cardiac markers;

(2) hematology;

(3) chemistry; and

(4) pregnancy testing.

(e) A written description of services provided shall be available to the medical staff.

(f) The laboratory shall ensure proper receipt and reporting of tissue specimens.

(g) The medical staff and a pathologist shall determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examination.

(h) When blood and blood components are stored, the facility shall have written procedures readily available containing directions on how to maintain the blood and blood components within permissible temperatures and including instructions to follow in the event of a power failure or other disruption of refrigeration.

(1) Blood transfusions shall be prescribed in accordance with facility policy and administered in accordance with a written protocol for administering blood and blood components and using infusion devices and ancillary equipment.

(2) Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to adopted, implemented, and enforced facility policy.

(3) Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.

(4) Facility staff shall observe the patient for potential adverse reactions during the transfusion and for an appropriate time thereafter and document the observations and patient's response.

(5) Pre-transfusion and post-transfusion vital signs shall be recorded.

(6) Following the transfusion, the blood transfusion record or a copy shall be made a part of the patient's medical record.

(i) The facility shall establish a mechanism for ensuring that the patient's physician or other licensed health care professional is made aware of critical value lab results, as established by the medical staff, before or after the patient is discharged. A physician shall read, date, sign, and authenticate all laboratory reports.

(j) A facility that provides laboratory services shall adopt, implement, and enforce written policies and procedures to manage, minimize, or eliminate the risks to laboratory personnel of exposure to potentially hazardous chemicals in the laboratory.

§509.50.Pharmaceutical Services.

(a) The facility shall be licensed as required by the Texas State Board of Pharmacy.

(b) The facility shall adopt, implement, and enforce policy and procedures for pharmaceutical services.

(c) The facility shall provide drugs, controlled substances, and biologicals in a safe and effective manner in accordance with professional practices and comply with all state and federal laws and regulations regarding pharmaceutical services.

(d) The facility may make pharmaceutical services available through contractual agreement. Pharmaceutical services provided under contract shall meet the same ethical practices, professional practices, and legal requirements that would be required if those services were provided directly by the facility.

§509.51.Radiology.

(a) The facility shall adopt, implement, and enforce policies and procedures for emergency radiological procedures.

(b) The facility shall provide radiological services that are immediately available on the premises to meet the emergency needs of patients and to adequately support the facility's clinical capabilities, including plain film X-ray.

(c) The facility shall provide computed tomography (CT) scan services and ultrasound services that are immediately available on the premises.

(d) A physician shall read, date, sign, and authenticate all examination reports.

(e) The radiology department shall meet all applicable federal, state, and local laws, codes, standards, rules, regulations, and ordinances.

(f) Procedure manuals shall include procedures for all examinations performed, infection control in the facility, treatment and examination rooms, personnel dress code, and equipment cleaning.

(g) Policies shall address the quality aspects of radiology services, including:

(1) performing radiology services only on the written order of a physician, advanced practice registered nurse, or other authorized practitioner (such orders shall be accompanied by a concise statement of the reason for the examination); and

(2) limiting the use of any radioactive sources in the facility to physicians who have been granted privileges for such use based on their training, experience, and current competence.

(h) Policies shall address safety, including:

(1) regulating use, removal, handling, and storage of any radioactive material that is required to be licensed by the Texas Department of State Health Services Radiation Control Program;

(2) precautions against electrical, mechanical, and radiation hazards;

(3) proper shielding where radiation sources are used;

(4) acceptable monitoring devices for all personnel who might be exposed to radiation that shall be worn by such personnel in any area with a radiation hazard;

(5) maintenance of radiation exposure records on personnel; and

(6) authenticated dated reports of all examinations performed added to the patient's medical record.

§509.52.Respiratory Services.

(a) The facility shall meet the respiratory needs of the patients in accordance with acceptable standards of practice.

(b) The facility shall adopt, implement, and enforce policies and procedures that describe the provision of respiratory care services in the facility.

(c) The organization of the respiratory care services shall be appropriate to the scope and complexity of the services offered.

(d) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures shall be designated in writing.

(e) If blood gases or other clinical laboratory tests are performed, staff shall comply with Clinical Laboratory Improvement Amendments of 1988 in accordance with the requirements specified in Code of Federal Regulations, Title 42, Part 493 (relating to Laboratory Services).

(f) Respiratory services shall be provided only on, and in accordance with, the orders of a physician, advanced practice registered nurse, or other authorized practitioner.

§509.53.Surgical Services within the Scope of the Practice of Emergency Medicine.

(a) Surgical procedures performed in the facility shall be limited to those emergency procedures that are approved by the governing body on the recommendation of medical staff.

(b) Adequate supervision of surgical procedures conducted in the facility shall be a responsibility of the governing body, recommended by medical staff, and provided by appropriate medical staff.

(c) Surgical procedures shall be performed only by physicians or practitioners who are licensed to perform surgical procedures in Texas and who have been granted privileges to perform those procedures by the governing body, on the recommendation of the medical staff, and after medical review of the physician's or practitioner's documented education, training, experience, and current competence.

(d) Surgical procedures to be performed in the facility shall be reviewed periodically as part of the peer review portion of the facility's quality assessment and performance improvement program.

(e) An appropriate history, physical examination, and pertinent preoperative diagnostic studies shall be incorporated into the patient's medical record before a surgical procedure.

(f) Unless otherwise provided by law, the necessity or appropriateness of the proposed surgical procedure, as well as any available alternative treatment techniques, shall be discussed with the patient, or if applicable, with the patient's legal representative before the surgical procedure.

(g) Licensed nurses and other personnel assisting in the provision of surgical services shall be appropriately trained and supervised and available in sufficient numbers for the surgical care provided.

(h) Each treatment or examination room shall be designed and equipped so that the types of surgical procedures conducted can be performed in a manner that protects the lives and ensures the physical safety of all persons in the area.

(1) If flammable agents are present in a treatment or examination room, the room shall be constructed and equipped in compliance with standards established by the National Fire Protection Association (NFPA 99, Annex 2, Flammable Anesthetizing Locations, 1999) and with applicable state and local fire codes.

(2) If nonflammable agents are present in a treatment or examination room, the room shall be constructed and equipped in compliance with standards established by the National Fire Protection Association (NFPA 99, Chapters 4 and 8, 1999) and with applicable state and local fire codes.

(i) With the exception of those tissues exempted by the governing body after medical review, tissues removed shall be examined by a pathologist, whose signed or authenticated report of the examination shall be made a part of the patient's medical record.

(j) A description of the findings and techniques of surgical procedures shall be accurately and completely incorporated into the patient's medical record immediately after the procedure by the physician or practitioner who performed the procedure. If the description is dictated, an accurate written summary shall be immediately available to the physicians and practitioners providing patient care and shall become a part of the patient's medical record.

(k) The facility shall provide adequate space, equipment, and personnel to ensure a safe environment for treating patients during surgical procedures, including adequate safeguards to protect the patient from cross infection.

(1) The facility shall isolate patients with communicable diseases.

(2) Acceptable aseptic techniques shall be used by all persons.

(3) Suitable equipment for rapid and routine sterilization shall be available.

(4) The facility shall implement environmental controls that ensure a safe and sanitary environment.

(l) Written policies and procedures for decontaminating, disinfecting, sterilizing, and storing sterile supplies shall be adopted, implemented, and enforced as described in §509.57 of this subchapter (relating to Sterilization).

(m) Emergency power adequate for the type of surgical procedures performed shall be available.

(n) Periodic calibration and preventive maintenance of all equipment shall be provided in accordance with manufacturer's guidelines.

(o) Unless otherwise provided by law, the informed consent of the patient or, if applicable, of the patient's legal representative shall be obtained before a surgical procedure is performed.

(p) The facility shall establish a written procedure for observing and caring for the patient during and after surgical procedures.

(q) The facility shall establish written protocols for instructing patients in self-care after surgical procedures, including written instructions to be given to patients who receive conscious sedation or regional anesthesia.

(r) Patients who have received anesthesia, other than solely topical anesthesia, shall be allowed to leave the facility only in the company of a responsible adult, unless the physician, physician assistant, or an advanced practice registered nurse writes an order that the patient may leave without the company of a responsible adult.

(s) The facility shall develop an effective written procedure for the immediately transferring to a hospital patients requiring emergency care beyond the capabilities of the facility. The facility shall have a written transfer agreement with a hospital as set forth in §509.65 of this subchapter (relating to Patient Transfer Policy).

§509.54.Medical Records.

(a) The facility shall develop and maintain a system for collecting, processing, maintaining, storing, retrieving, authenticating, and distributing patient medical records.

(b) The facility shall establish an individual medical record for each patient.

(c) All clinical information relevant to a patient shall be readily available to physicians or practitioners involved in the care of that patient.

(d) Except when otherwise required or permitted by law, any record that contains clinical, social, financial, or other data on a patient shall be strictly confidential and shall be protected from loss, tampering, alteration, improper destruction, and unauthorized or inadvertent disclosure.

(e) The facility shall designate a person to be in charge of medical records. The person's responsibilities include:

(1) confidential, secure, and safe storage of medical records;

(2) timely retrieval of individual medical records on request;

(3) specific identification of each patient's medical record;

(4) supervision of collecting, processing, maintaining, storing, retrieving, and distributing medical records; and

(5) maintenance of a predetermined organized medical record format.

(f) The facility shall retain medical records in their original or legally reproduced form for a period of at least 10 years. A legally reproduced form is a medical record retained in hard copy, microform (microfilm or microfiche), or electronic medium. The facility shall retain films, scans, and other image records for a period of at least five years.

(1) The facility shall not destroy medical records that relate to any matter that is involved in litigation if the facility knows the litigation has not been finally resolved.

(2) For medical records of a patient less than 18 years of age at the time of last treatment, the facility may dispose of those medical records after the date of the patient's 20th birthday or after the 10th anniversary of the date on which the patient was last treated, whichever date is later, unless the records are related to a matter that is involved in litigation that the facility knows has not been finally resolved.

(3) If a facility plans to close, the facility shall arrange for disposition of the medical records in accordance with applicable law. The facility shall notify the Texas Health and Human Services Commission at the time of closure of the disposition of the medical records, including where the medical records will be stored and the name, address, and phone number of the custodian of the records.

(g) Except when otherwise required by law, the content and format of medical records, including the sequence of information, shall be uniform.

(h) Medical records shall be available to authorized physicians and practitioners any time the facility is open to patients.

(i) The facility shall include in patients' medical records:

(1) complete patient identification;

(2) date, time, and means of arrival and discharge;

(3) allergies and untoward reactions to drugs recorded in a prominent and uniform location;

(4) all medications administered and the drug dose, route of administration, frequency of administration, and quantity of all drugs administered or dispensed to the patient by the facility and entered on the patient's medical record;

(5) significant medical history of illness and results of physical examination, including the patient's vital signs;

(6) a description of any care given to the patient before the patient's arrival at the facility;

(7) a complete detailed description of treatment and procedures performed in the facility;

(8) clinical observations including the results of treatment, procedures, and tests;

(9) diagnostic impression;

(10) a pre-anesthesia evaluation by an individual qualified to administer anesthesia when administered;

(11) a pathology report on all tissues removed, except those exempted by the governing body;

(12) documentation of a properly executed informed consent when necessary;

(13) for patients with a length of stay greater than eight hours, an evaluation of nutritional needs and evidence of how identified needs were met;

(14) evidence of patient evaluation by a physician or advanced practice registered nurse before dismissal; and

(15) conclusion at the termination of evaluation or treatment, including final disposition, the patient's condition on discharge or transfer, and any instructions given to the patient or family for follow-up care.

(j) Medical advice given to a patient by telephone shall be entered in the patient's medical record and dated, timed, and authenticated.

(k) Entries in medical records shall be legible, accurate, complete, dated, timed, and authenticated by the person responsible for providing or evaluating the service provided no later than 48 hours after discharge.

(l) To ensure continuity of care, medical records shall be transferred to the physician, practitioner, or facility to whom the patient was referred, if applicable.

§509.55.Infection Control.

(a) The facility shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The facility shall have an infection control program for prevention, control, and surveillance of infections and communicable diseases.

(1) The facility shall designate an infection control professional. The facility shall adopt, implement, and enforce policies governing prevention, control, and surveillance of infections and communicable diseases.

(2) The facility shall have a system for identifying, reporting, investigating, and controlling health care-associated infections and communicable diseases between patients and personnel.

(3) The infection control professional shall maintain a log of all reportable diseases and health care-associated infections designated as epidemiologically significant according to the facility's infection control policies.

(4) The facility shall adopt, implement, and enforce a written policy for reporting all reportable diseases to the local health authority and the Texas Department of State Health Services Infectious Disease Prevention Section, in accordance with 25 TAC Chapter 97 (relating to Communicable Diseases).

(5) The infection control program shall include active participation by the medical staff, nursing staff, pharmacist, and other practitioners as appropriate.

(b) The medical director is responsible for ensuring the facility-wide quality assessment and performance improvement program and training programs address problems identified by the infection control professional.

(c) The medical director is responsible for ensuring that the facility implements successful corrective action plans in affected problem areas.

(d) The facility shall adopt, implement, and enforce a written policy to monitor compliance of the facility and its personnel and medical staff with universal precautions in accordance with Texas Health and Safety Code Chapter 85 (relating to Acquired Immune Deficiency Syndrome and Human Immunodeficiency Virus Infection).

§509.56.Sanitary Conditions and Hygienic Practices.

(a) General infection control measures. Universal precautions shall be followed in the facility for all patient care activities in accordance with Code of Federal Regulations, Title 29 §1910.1030(d)(1) - (3) (relating to Bloodborne Pathogens) and Texas Health and Safety Code Chapter 85, Subchapter I (relating to Prevention of Transmission of HIV and Hepatitis B Virus by Infected Health Care Workers).

(b) Physical environment.

(1) A facility shall develop, implement, and enforce policies and procedures to provide and actively monitor a safe, functional, comfortable, and sanitary environment that minimizes or prevents transmission of infectious diseases for all patients and visitors and the public.

(2) Blood spills shall be cleaned immediately or as soon as is practical with a disposable cloth and an appropriate chemical disinfectant.

(A) If a commercial liquid chemical disinfectant is used, the surface shall be subjected to intermediate-level disinfection in accordance with the manufacturer's directions for use.

(B) If a solution of chlorine bleach (sodium hypochlorite) is used, the solution shall be at least 1:100 sodium hypochlorite and mixed in accordance with the manufacturer's directions for use. The surface to be treated shall be compatible with this type of chemical treatment.

§509.57.Sterilization.

(a) A person qualified by education, training, and experience shall supervise the sterilization of all supplies and equipment. Staff responsible for sterilizing supplies and equipment shall participate in a documented continuing education program. New employees shall receive initial orientation and on-the-job training. Staff using chemical disinfectants shall have received training on their use.

(b) The facility shall adopt, implement, and enforce written policies and procedures for decontamination and sterilization activities. Policies shall include receiving, cleaning, decontaminating, disinfecting, preparing, and sterilizing reusable items, as well as assembling, wrapping, storing, distributing, and quality control of sterile items and equipment. The infection control practitioner or committee shall review and approve these written policies at least every other year.

(c) Every facility shall provide equipment adequate for sterilizing supplies and equipment, as needed. Equipment shall be maintained and operated to accurately sterilize the various materials required.

(d) Where cleaning, preparation, and sterilization functions are performed in the same room or unit, the physical facilities, equipment, and policies and procedures for their use, shall effectively separate soiled or contaminated supplies and equipment from clean or sterilized supplies and equipment. Hand-washing facilities shall be provided, and a separate sink shall be provided for safe disposal of liquid waste.

(e) All containers for solutions, drugs, flammable solvents, ether, alcohol, and medicated supplies shall be clearly labeled to indicate contents. Containers that are sterilized by the facility shall be labeled to be identifiable before and after sterilization. Sterilized items shall have a load control identification that indicates the sterilizer used, the cycle or load number, and the sterilization date.

(f) A facility shall comply with the following sterilizer requirements.

(1) Steam sterilizers (saturated steam under pressure) shall be used to sterilize heat- and moisture-stable items. Steam sterilizers shall be used according to manufacturer's written instructions.

(2) Ethylene oxide (EO) sterilizers shall be used for processing heat- and moisture-sensitive items. EO sterilizers and aerators shall be used and vented according to the manufacturer's written instructions.

(3) Flash sterilizers shall be used only for emergency sterilization of clean, unwrapped instruments and porous items.

(g) A facility shall comply with the following sterilization preparation requirements.

(1) All items to be sterilized shall be prepared to reduce the bioburden. All items shall be thoroughly cleaned, decontaminated, and prepared in a clean, controlled environment.

(2) All articles to be sterilized shall be arranged so all surfaces will be directly exposed to the sterilizing agent for the prescribed time and temperature.

(3) All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized.

(h) A facility shall comply with the following external chemical indicator requirements.

(1) External chemical indicators, also known as sterilization process indicators, shall be used on each package to be sterilized, including items being flash sterilized to indicate that items have been exposed to the sterilization process.

(2) The indicator results shall be interpreted according to manufacturer's written instructions and indicator reaction specifications.

(3) A log shall be maintained with the load identification, indicator results, and identification of the contents of the load.

(i) Biological indicators are commercially available microorganisms (e.g., United States Food and Drug Administration-approved strips or vials of Bacillus species endospores) that can be used to verify the performance of waste treatment equipment and processes or sterilization equipment and processes.

(1) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used.

(2) Biological indicators shall be included in at least one run each week of use for steam sterilizers, at least one run each day of use for low-temperature hydrogen peroxide gas sterilizers, and every load for EO sterilizers.

(3) Biological indicators shall be included in every load that contains implantable objects.

(4) A log shall be maintained with the load identification, biological indicator results, and identification of the contents of the load.

(5) If a test is positive, the sterilizer shall immediately be taken out of service.

(A) Implantable items shall be recalled and reprocessed if a biological indicator test (spore test) is positive.

(B) All available items shall be recalled and reprocessed if a sterilizer malfunction is found, and a list of those items not retrieved in the recall shall be submitted to infection control.

(C) A malfunctioning sterilizer shall not be put back into use until it has been serviced and successfully tested according to the manufacturer's recommendations.

(j) A facility shall comply with the following disinfection requirements.

(1) The facility shall adopt, implement, and enforce written policies, approved by the infection control committee, for the use of chemical disinfectants.

(2) The manufacturer's written instructions for the use of disinfectants shall be followed.

(3) An expiration date, determined according to manufacturer's written recommendations, shall be marked on the container of disinfection solution currently in use.

(4) Disinfectant solutions shall be kept covered and used in well-ventilated areas.

(5) Chemical germicides that are registered with the United States Environmental Protection Agency as "sterilants" may be used either for sterilization or high-level disinfection.

(6) All staff personnel using chemical disinfectants shall receive training on their use.

(k) A facility shall comply with the following performance record requirements.

(1) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of five years.

(2) Each sterilizer shall be monitored continuously during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained and shall include:

(A) the sterilizer identification;

(B) sterilization date;

(D) contents of each load;

(E) duration and temperature of exposure phase (if not provided on sterilizer recording charts);

(F) identification of operator or operators;

(G) results of biological tests and dates performed;

(H) time-temperature recording charts from each sterilizer;

(I) gas concentration and relative humidity (if applicable); and

(J) any other test results.

(l) Storage of sterilized items shall comply with the following requirements.

(1) Sterilized items shall be transported to maintain cleanliness and sterility and to prevent physical damage.

(2) Sterilized items shall be stored in well-ventilated, limited access areas with controlled temperature and humidity.

(3) The facility shall adopt, implement, and enforce a policy that describes the mechanism used to determine the shelf life of sterilized packages.

(m) Qualified personnel shall perform preventive maintenance of all sterilizers on a scheduled basis according to adopted, implemented, and enforced policy, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review at the facility within two hours of request by the Texas Health and Human Services Commission.

§509.58.Linen and Laundry Services.

(a) The facility shall adopt, implement, and enforce policies to provide sufficient clean linen to ensure the comfort of the patient.

(b) For purposes of this subsection, contaminated linen is linen that has been soiled with blood or other potentially infectious materials or may contain sharps. Other potentially infectious materials means:

(1) the following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;

(2) any unfixed tissue or organ (other than intact skin) from a human (living or dead); and

(3) Human Immunodeficiency Virus (HIV)-containing cell or tissue cultures, organ cultures, and HIV or Hepatitis B Virus (HBV)-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

(c) The facility, whether it operates its own laundry or uses a commercial service, shall ensure that employees of a facility involved in transporting, processing, or otherwise handling clean or soiled linen shall be given initial and follow-up in-service training to ensure a safe product for patients and to safeguard employees in their work.

(d) Employees who have contact with contaminated linen shall wear gloves and other appropriate personal protective equipment.

(e) Clean linen shall be handled, transported, and stored by methods that will ensure its cleanliness.

(f) Contaminated linen shall be handled as little as possible and with a minimum of agitation.

(1) Contaminated linen shall not be sorted or rinsed in patient care areas.

(2) Contaminated linen shall be bagged or put into carts at the location where it was used.

(3) Contaminated linen shall be placed and transported in bags or containers that are labeled or color-coded.

(4) Bags containing contaminated linen shall be closed before transport.

(5) Whenever contaminated linen is wet and presents a reasonable likelihood of soak-through or leakage from the bag or container, the linen shall be deposited and transported in bags that prevent leakage of fluids to the exterior.

(g) All linen placed in chutes shall be bagged.

(h) If chutes are not used to convey linen to a central receiving or sorting room, adequate space shall be allocated in the facility for holding the bagged contaminated linen.

(i) Linen shall be processed in the following manner.

(1) If hot water is used, linen shall be washed with detergent in water with a temperature of at least 71 degrees Centigrade (160 degrees Fahrenheit) for 25 minutes.

(2) If low-temperature (less than or equal to 70 degrees Centigrade, 158 degrees Fahrenheit) laundry cycles are used, chemicals suitable for low-temperature washing at proper use concentration shall be used.

(3) Fabrics soiled with blood may be commercially dry cleaned (because dry cleaning eliminates the risk of pathogen transmission).

(4) Flammable liquids shall not be used to process laundry but may be used for equipment maintenance.

§509.59.Waste and Waste Disposal.

(a) Special waste and liquid or sewage waste management.

(1) Facilities shall comply with the requirements set forth by the Texas Commission on Environmental Quality (TCEQ) in 30 TAC Chapter 326 (relating to Medical Waste Management).

(2) All sewage and liquid wastes shall be disposed of in a municipal sewerage system or a septic tank system permitted by the TCEQ in accordance with 30 TAC Chapter 285 (relating to On-Site Sewage Facilities).

(3) Facilities shall comply with the requirements set forth in 25 TAC Chapter 1, Subchapter K (relating to Definition, Treatment, and Disposition of Special Waste from Health Care-Related Facilities).

(b) Waste receptacles.

(1) Waste receptacles shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles shall be routinely emptied of their contents at a central location into closed containers.

(2) Waste receptacles shall be properly cleaned with soap and hot water, followed by treatment of inside surfaces of the receptacles with a germicidal agent.

(3) All containers for other municipal solid waste shall be leak-resistant, have tight-fitting covers, and be rodent-proof.

(4) Non-reusable containers shall be of suitable strength to minimize animal scavenging or rupture during collection operations.

§509.60.Patient Rights.

(a) Patients shall be treated with respect, consideration, and dignity.

(b) Patients shall be provided appropriate privacy.

(c) Patient records shall be treated confidentially. Patients shall be given the opportunity to approve or refuse release of patient records, except when release of the records is authorized by law.

(d) Patients shall be provided, to the degree known, appropriate information concerning their diagnosis, treatment, and prognosis. When it is medically inadvisable to give such information to a patient, the information shall be provided to a person designated by the patient or a legally authorized person.

(e) Patients shall be given the opportunity to participate in decisions involving their health care, except when the patient's participation is contraindicated for medical reasons.

(f) The facility shall provide information to patients and staff concerning:

(1) patient rights, including those specified in subsections (a) - (e) of this section;

(2) patient conduct and responsibilities;

(3) services available at the facility;

(4) fees for services provided;

(5) payment policies; and

(6) methods for expressing complaints and suggestions to the facility.

(g) Marketing or advertising shall not be misleading to patients.

(h) A facility shall post a notice of fees in accordance with Texas Health and Safety Code §254.155 (relating to Notice of Fees).

(i) A facility shall provide to a patient or a patient's legally authorized representative a written disclosure statement, detailing the facility's fees and health benefit plans, in accordance with Texas Health and Safety Code §254.156 (relating to Disclosure Statement Required).

(j) A facility shall comply with Texas Health and Safety Code Chapter 324, Subchapter C (relating to Billing of Facility Services and Supplies).

§509.61.Abuse and Neglect.

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

(1) Abuse--The negligent or willful infliction of injury, unreasonable confinement, intimidation, or cruel punishment, including pain or sexual abuse, that adversely affects the physical, mental, or emotional welfare of a patient.

(2) Exploitation--The use of a patient's resources for monetary or personal benefit, profit, or gain without the informed consent of the patient.

(3) Illegal conduct--Conduct prohibited by law.

(4) Neglect--The failure to provide goods or services that are necessary to avoid adversely affecting the physical, mental, or emotional welfare of a patient.

(5) Unethical conduct--Conduct prohibited by the ethical standards adopted by state or national professional organizations for their respective professions or by rules established by the state licensing agency for the respective profession.

(6) Unprofessional conduct--Conduct prohibited under rules adopted by the state licensing agency for the respective profession.

(b) The facility or a person associated with a facility, including an employee, volunteer, health care professional, or other person, shall immediately report all incidents of abuse, neglect, exploitation, illegal conduct, unethical conduct, or unprofessional conduct to the Texas Health and Human Services Commission (HHSC) and any other appropriate regulatory agency. This includes any information that would reasonably cause a person to believe that an incident of abuse, neglect, exploitation, illegal conduct, unethical conduct, or unprofessional conduct has occurred, is occurring, or will occur.

(c) A facility shall prominently and conspicuously post for display a statement of the duty to report abuse, neglect, exploitation, illegal conduct, unethical conduct, or unprofessional conduct.

(1) The display shall be posted in a public area of the facility and shall be readily visible to patients, residents, volunteers, employees, and visitors.

(2) The statement shall be in English and in a second language as appropriate to the demographic makeup of the community served.

(3) The statement shall contain the contact information for HHSC Complaint and Incident Intake.

§509.62.Reporting Requirements.

(a) A facility shall report the following incidents to the Texas Health and Human Services Commission (HHSC):

(1) the death of a patient while under the care of the facility;

(2) a patient stay exceeding 23 hours; and

(3) 9-1-1 activation or the emergency transfer of a patient from the facility to a hospital.

(b) Reports under subsection (a) of this section shall be on a form provided by HHSC. The report shall contain a written explanation of the incident and the name of the individual responsible. The report shall be submitted online or through a telephone call to HHSC Complaint and Incident Intake not later than the 10th business day after the incident.

(c) A facility shall report any abuse, theft, or diversion of controlled drugs in accordance with applicable federal and state laws and shall report the incident to the chief executive officer of the facility.

(d) A facility shall report occurrences of fires in the facility as specified under 25 TAC Chapter 131, Subchapter F (relating to Fire Prevention Safety Requirements).

§509.63.Quality Assessment and Performance Improvement.

(a) Each facility shall develop, implement, maintain, and evaluate an effective, ongoing, facility-wide, data-driven, interdisciplinary quality assessment and performance improvement (QAPI) program. The program shall be individualized to the facility and meet the criteria and standards described in this section.

(b) The program shall reflect the complexity of the facility's organization and services involved. All facility services (including services furnished under contract or arrangement) shall focus on indicators related to improved health outcomes and prevention and reduction of medical errors.

(c) The program shall include an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with the identification and reduction of medical errors.

(d) The facility shall demonstrate that facility staff, including the medical, nursing, and pharmacy staff, evaluate the provision of emergency care and patient services, set treatment goals, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until resolution is achieved.

(e) The facility shall measure, analyze, and track quality indicators, or other aspects of performance that the facility adopts or develops, that reflect processes of care and facility operations.

(f) The facility shall provide evidence supporting that the facility continuously reviews aggregate patient data, including identification and tracking of patient infections, for trends.

(g) Core staff members, including the medical, nursing, and pharmacy staff, shall actively participate in the QAPI activities, including QAPI meetings.

(1) QAPI meetings shall be held monthly, or more often as necessary, to identify or correct problems.

(2) QAPI meetings shall be documented.

(h) The facility's QAPI program shall include:

(1) an ongoing review of key elements of care using comparative and trend data to include aggregate patient data;

(2) identification of areas where performance measures or outcomes indicate an opportunity for improvement;

(3) appointment of interdisciplinary improvement teams to:

(A) identify, measure, analyze, and track indicators for variation from desired outcomes;

(B) create and implement improvement plans;

(D) continue monitoring and improvement activities until resolution of the improvement plan;

(4) establishing and monitoring quality indicators related to improved health outcomes, which includes establishing and monitoring a level of performance consistent with current professional knowledge for each quality assessment indicator that must influence or relate to the desired outcomes themselves;

(5) monthly measurement, analysis, and tracking of at least the following indicators:

(A) infection control (staff and patient screening; standard precautions);

(B) adverse events;

(D) complaints and suggestions (from patients, family, or staff);

(E) staffing to include orientation, training, delegation, licensing and certification, and non-adherence to policies and procedures by facility staff;

(F) safety (fire and disaster preparedness, use of the Texas Health and Human Services Commission (HHSC) emergency/disaster notification form, and disposal of special waste); and

(G) clinical records review to include treatment errors and medication errors; and

(6) the facility shall continuously monitor performance, take actions that result in performance improvement, and track performance to ensure that improvements are sustained over time. The facility shall immediately correct any identified problems that threaten the health and safety of patients.

(i) HHSC may review a facility's QAPI activities to determine compliance with this section.

(1) An HHSC inspector shall verify that the facility has a QAPI program, which addresses concerns relating to quality of care provided to its patients and that the core staff members have knowledge of and the ability to access the facility's QAPI program.

(2) HHSC may not require disclosure of QAPI program records, except when disclosure is necessary for HHSC to determine compliance with this section.

§509.64.Safety and Preparedness.

(a) The facility shall follow the requirements in 25 TAC Chapter 131, Subchapter F (relating to Fire Prevention and Safety Requirements).

(b) The facility shall submit emergency and disaster information to the Texas Health and Human Services Commission (HHSC) using the HHSC Emergency/Disaster Notification form located on HHSC's website.

(c) The facility shall obtain an annual fire safety inspection from the local fire authority in whose jurisdiction the facility is based.

§509.65.Patient Transfer Policy.

(a) General.

(1) The governing body of each facility shall adopt, implement, and enforce a policy relating to patient transfers that is consistent with this section and contains each of the requirements in subsection (b) of this section. The policies shall identify facility staff that has authority to represent the facility and the physician regarding transfers from the facility.

(2) The governing body shall adopt the transfer policy after consultation with the medical staff, and the transfer policy shall apply to transfers to hospitals licensed under Texas Health and Safety Code Chapter 241 (relating to Hospitals) and Chapter 577 (relating to Private Mental Hospitals and Other Mental Health Facilities), as well as transfers to hospitals that are exempt from licensing.

(3) The transfer policy shall govern transfers not covered by a transfer agreement.

(4) The transfer policy shall include a written operational plan to provide for patient transfer transportation services if the facility does not provide its own patient transfer transportation services.

(5) The governing body, after consultation with the medical staff, shall implement its transfer policy by adopting transfer agreements with hospitals in accordance with §509.66 of this subchapter (relating to Patient Transfer Agreements).

(6) The transfer policy shall recognize and comply with the applicable requirements of Texas Health and Safety Code Chapter 61 (relating to Indigent Health Care and Treatment Act).

(7) The transfer policy shall acknowledge contractual obligations and comply with statutory or regulatory obligations that may exist concerning a patient and a designated provider.

(8) The transfer policy shall require that all reasonable steps are taken to secure the written informed consent of a patient, or a person acting on a patient's behalf, when refusing a transfer or related examination and treatment. Reasonable steps include:

(A) a factual explanation of the increased medical risks to the patient reasonably expected from not being transferred, examined, or treated at the transferring hospital;

(B) a factual explanation of any increased risks to the patient from not effecting the transfer; and

(C) a factual explanation of the medical benefits reasonably expected from the provision of appropriate treatment at another hospital.

(9) The informed refusal of a patient, or a person acting on a patient's behalf, to examination, evaluation, or transfer shall be documented and signed if possible by the patient or by a person acting on the patient's behalf, dated and witnessed by the attending physician or facility employee, and placed in the patient's medical record.

(10) The transfer policy shall recognize the right of an individual to request a transfer into the care of a physician and a hospital of the individual's own choosing.

(b) Requirements for transfer of patients from facilities to hospitals.

(1) The transfer policy shall provide that the transfer of a patient may not be predicated upon arbitrary, capricious, or unreasonable discrimination based upon race, religion, national origin, age, sex, physical condition, economic status, insurance status, or ability to pay.

(2) The transfer policy shall recognize the right of an individual to request transfer into the care of a physician and hospital of the individual's own choosing; however, if a patient requests or consents to transfer for economic reasons and the patient's choice is predicated upon or influenced by representations made by the transferring physician or facility administration regarding the availability of medical care and hospital services at a reduced cost or no cost to the patient, physician or facility administration shall fully disclose to the patient the eligibility requirements established by the patient's chosen physician or hospital.

(3) The transfer policy shall provide that each patient who arrives at the facility is:

(A) evaluated by a physician at the time the patient presents; and

(B) personally examined and evaluated by the physician before an attempt to transfer is made.

(4) The policy of the transferring facility and receiving hospital shall provide that licensed nurses and other qualified personnel are available and on duty to assist with patient transfers. The policy shall provide that written protocols or standing delegation orders are in place to guide facility personnel when a patient requires transfer to another hospital.

(5) Special requirements related to the transfer of patients who have emergency medical conditions:

(A) If a patient at a facility has an emergency medical condition that has not been stabilized, or when stabilization of the patient's vital signs is not possible because the facility does not have the appropriate equipment or personnel to correct the underlying process, the facility shall evaluate and treat the patient and transfer the patient as quickly as possible.

(B) The transfer policy shall provide that the facility may not transfer a patient with an emergency medical condition that has not been stabilized unless:

(i) the individual or the individual's legally authorized representative, after being informed of the facility's obligations under this section and the risk of transfer, requests the transfer, in writing, and indicates the reasons for the request, as well as that he or she is aware of the risks and benefits of the transfer; or

(ii) a physician has signed a certification, which includes a summary of the risks and benefits, that, based on the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at a hospital outweigh the increased risks to the patient and, in the case of labor, to the unborn child from effecting the transfer.

(C) Except as is specifically provided in subsection (a)(6) and (7) of this section, the transfer policy shall provide that the transfer of patients who have emergency medical conditions, as determined by a physician, shall be undertaken for medical reasons only. The facility must provide medical treatment within its capacity that minimizes the risks to the individual's health and, in the case of a woman in labor, the health of the unborn child.

(6) The transfer policy shall provide for the following physician's duties and standard of care requirements.

(A) The transferring physician shall determine and order life support measures that are medically appropriate to stabilize the patient before transfer and to sustain the patient during transfer.

(B) The transferring physician shall determine and order the utilization of appropriate personnel and equipment for the transfer.

(C) In determining the use of medically appropriate life support measures, personnel, and equipment, the transferring physician shall exercise that degree of care that a reasonable and prudent physician exercising ordinary care in the same or similar locality would use for the transfer.

(D) Except as allowed under paragraph (5)(B) of this subsection, before each patient transfer, the physician who authorizes the transfer shall personally examine and evaluate the patient to determine the patient's medical needs and to ensure that the proper transfer procedures are used.

(E) Before transfer, the transferring physician shall ensure that a receiving hospital and physician that are appropriate to the medical needs of the patient have accepted responsibility for the patient's medical treatment and hospital care.

(7) The facility's medical staff shall review appropriate records of patients transferred from the facility to determine that the appropriate standard of care has been met.

(8) A facility shall comply with the following medical record requirements.

(A) The facility's policy shall require that a copy of those portions of the patient's medical record that are available and relevant to the transfer and to the continuing care of the patient be forwarded to the receiving physician and receiving hospital with the patient. If all necessary medical records for the continued care of the patient are not available at the time the patient is transferred, the records shall be forwarded to the receiving physician and hospital as soon as possible.

(B) The medical record shall contain at least:

(i) a brief description of the patient's medical history and physical examination;

(ii) a working diagnosis and recorded observations of physical assessment of the patient's condition at the time of transfer;

(iii) the reason for the transfer;

(iv) the results of all diagnostic tests, such as laboratory tests;

(v) pertinent radiological films and reports; and

(vi) any other pertinent information.

(9) A facility shall comply with the following memorandum of transfer requirements.

(A) The facility's policy shall require that a memorandum of transfer be completed for every patient who is transferred.

(B) The memorandum shall contain the:

(i) patient's full name, if known;

(ii) patient's race, religion, national origin, age, sex, physical handicap, if known;

(iii) patient's address and next of kin, address, and phone number, if known;

(iv) names, telephone numbers, and addresses of the transferring and receiving physicians;

(v) names, addresses, and telephone numbers of the transferring facility and receiving hospital;

(vi) time and date on which the patient first presented or was presented to the transferring physician and transferring facility;

(vii) time and date on which the transferring physician secured a receiving physician;

(viii) name, date, and time hospital administration was contacted in the receiving hospital;

(ix) signature, time, and title of the transferring facility administration who contacted the receiving hospital;

(x) certification required by paragraph (5)(B)(ii) of this subsection, if applicable (the certification may be part of the memorandum of transfer form or may be on a separate form attached to the memorandum of transfer form);

(xi) time and date on which the receiving physician assumed responsibility for the patient;

(xii) time and date on which the patient arrived at the receiving hospital;

(xiii) signature and date of receiving hospital administration;

(xiv) type of vehicle and company used to transport the patient;

(xv) type of equipment and personnel needed in the transfer;

(xvi) name and city of hospital to which patient was transported;

(xvii) diagnosis by transferring physician; and

(xviii) attachments by transferring facility.

(C) A copy of the memorandum of transfer shall be retained by the transferring facility. The memorandum shall be filed separately from the patient's medical record and in a manner that will facilitate its inspection by HHSC. All memorandum of transfer forms filed separately shall be retained for at least five years.

(1) the facility fails to comply with the requirements of this section; or

(2) the governing body fails or refuses to:

(A) adopt a transfer policy that is consistent with this section and contains each of the requirements in subsection (b) of this section;

(B) adopt a memorandum of transfer form that meets the minimum requirements for content contained in this section; or

§509.66.Patient Transfer Agreements.

(a) General provisions.

(1) Patient transfer agreements between a facility and hospitals are mandatory.

(2) The facility shall submit the transfer agreement to the Texas Health and Human Services Commission (HHSC) for review to determine if the agreement meets the requirements of subsection (b) of this section.

(3) Multiple transfer agreements may be entered into by a facility based upon the type or level of medical services available at other hospitals.

(b) Minimum requirements for patient transfer agreements. Patient transfer agreements shall include specific language that is consistent with:

(1) Texas Health and Safety Code Chapter 61 (relating to Indigent Health Care Treatment Act), in accordance with §509.65(a)(6) of this subchapter (relating to Patient Transfer Policy);

(2) discrimination, in accordance with §509.65(b)(1) of this subchapter;

(3) patient's right to request transfer, in accordance with §509.65(b)(2) of this subchapter;

(4) transfer of patients with emergency medical conditions, in accordance with §509.65(b)(5) of this subchapter;

(5) physician's duties and standard of care, in accordance with §509.65(b)(6) of this chapter;

(6) medical records, in accordance with §509.65(b)(8) of this subchapter; and

(7) memorandum of transfer, in accordance with §509.65(b)(9) of this chapter.

(1) The facility shall submit the following documents to HHSC for review so HHSC may determine whether the transfer agreements comply with this section's requirements:

(A) a copy of the current or proposed agreement signed by the representatives of the facility and the hospital;

(B) the date of the adoption of the agreement; and

(2) HHSC may waive the documents submission required under paragraph (1) of this subsection to avoid the repetitious submission of required documentation and approved agreements.

(3) If a governing body or a governing body's designee executes a transfer agreement and the entire text of that agreement consists of the entire text of an agreement that has been previously approved by HHSC, the governing body or the governing body's designee is not required to submit the later agreement for review. On the date the later agreement is fully executed and before the later agreement is implemented, the governing body or the governing body's designee shall give notice to HHSC that the later agreement has been executed.

(4) HHSC shall review the agreement not later than 30 calendar days after the date HHSC receives the agreement to determine if the agreement is consistent with the requirements of this section.

(5) After HHSC review of the agreement, if HHSC determines that the agreement is consistent with the requirements contained in this section, HHSC shall notify the facility administration that the agreement has been approved.

(6) If HHSC determines that the agreement is not consistent with the requirements contained in this section, HHSC shall give notice to the facility administration that the agreement is deficient and provide recommendations for correction.

(7) A transfer agreement will be considered in compliance if it is consistent with the rules that were in effect at the time the transfer agreement was executed and approved by HHSC.

(d) Amendments to an agreement.

(1) The governing body of a facility or governing body's designee may adopt proposed amendments to a transfer agreement that has been approved by HHSC. Before the facility implements the amendments, the governing body or the governing body's designee shall submit the proposed amendments to HHSC for review in the same manner as the agreement was submitted.

(2) HHSC shall review the amendments and approve or reject them in the same manner as provided for the review of the agreement.

(e) Complaints. Complaints alleging a violation of a transfer agreement shall be treated in the same manner as complaints alleging violations of the Act or this chapter.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 29, 2023.

TRD-202302361

Karen Ray

Chief Counsel

Health and Human Services Commission

Earliest possible date of adoption: August 13, 2023

For further information, please call: (512) 834-4591

SUBCHAPTER D. INSPECTION AND INVESTIGATION PROCEDURES

26 TAC §§509.81 - 509.86

STATUTORY AUTHORITY

The new rules implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 254.

§509.81.Integrity of Inspections and Investigations.

(a) In order to preserve the integrity of the Texas Health and Human Services Commission's (HHSC's) inspection and investigation process, a facility:

(1) shall not record, listen to, or eavesdrop on any HHSC interview with facility staff or patients unless HHSC has granted permission; or

(2) shall not record, listen to, or eavesdrop on any internal discussion by or among HHSC staff unless it first informs HHSC staff that it will do so and obtains HHSC's written approval before beginning to record, listen to, or eavesdrop on the discussion.

(b) A facility shall inform HHSC when security cameras or other existing recording devices in the facility are in operation during any internal discussion by or among HHSC staff.

§509.82.Inspections.

(a) The Texas Health and Human Services Commission (HHSC) may conduct an unannounced, on-site inspection of a facility at any reasonable time, including when treatment services are provided, to inspect, investigate, or evaluate compliance with or prevent a violation of:

(1) any applicable statute or rule;

(2) a facility's plan of correction;

(3) an order or special order of the executive commissioner or the executive commissioner's designee;

(4) a court order granting injunctive relief; or

(5) for other purposes relating to regulation of the facility.

(b) An applicant or licensee, by applying for or holding a license, consents to entry and inspection of any of its facilities by HHSC.

(1) initial, change of ownership, or relocation inspections for the issuance of a new license;

(2) inspections related to changes in status, such as new construction or changes in services, designs, or bed numbers;

(3) routine inspections, which may be conducted without notice and at HHSC's discretion, or prior to renewal;

(4) follow-up on-site inspections, conducted to evaluate implementation of a plan of correction for previously cited deficiencies;

(5) inspections to determine if an unlicensed facility is offering or providing, or purporting to offer or provide, treatment; and

(6) entry in conjunction with any other federal, state, or local agency's entry.

(d) A facility shall cooperate with any HHSC inspection and shall permit HHSC to examine the facility's grounds, buildings, books, records, and other documents and information maintained by or on behalf of the facility.

(e) A facility shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.

(f) A facility shall permit HHSC to inspect and copy any requested information, unless prohibited by law. If it is necessary for HHSC to remove documents or other records from the facility, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.

(g) HHSC shall maintain the confidentiality of facility records as applicable under state and federal law.

(h) Upon entry, HHSC holds an entrance conference with the facility's designated representative to explain the nature, scope, and estimated duration of the inspection.

(i) During the inspection, the HHSC representative gives the facility representative an opportunity to submit information and evidence relevant to matters of compliance being evaluated.

(j) When an inspection is complete, the HHSC representative holds an exit conference with the facility representative to inform the facility representative of any preliminary findings of the inspection, including possible health and safety concerns. The facility may provide any final documentation regarding compliance during the exit conference.

§509.83.Complaint Investigations.

(a) At the time of the initial physician assessment, a facility shall provide each patient and applicable consenter with a written statement identifying the Texas Health and Human Services Commission (HHSC) as the agency responsible for investigating complaints against the facility.

(1) The statement shall inform persons that they may direct a complaint to HHSC Complaint and Incident Intake (CII) and include current CII contact information, as specified by HHSC.

(2) The facility shall prominently and conspicuously post this statement in patient common areas and in visitor's areas and waiting rooms so that it is readily visible to patients, employees, and visitors. The information shall be in English and in a second language appropriate to the demographic makeup of the community served.

(b) HHSC evaluates all complaints. A complaint must be submitted using HHSC's current CII contact information for that purpose, as described in subsection (a) of this section.

(c) HHSC documents, evaluates, and prioritizes complaints based on the seriousness of the alleged violation and the level of risk to patients, personnel, and the public.

(1) Allegations determined to be within HHSC's regulatory jurisdiction relating to freestanding emergency medical care facilities may be investigated under this chapter.

(2) HHSC may refer complaints outside HHSC's jurisdiction to an appropriate agency, as applicable.

(d) HHSC shall conduct investigations to evaluate a facility's compliance following a complaint of abuse, neglect, or exploitation; or a complaint related to the health and safety of patients.

(e) HHSC may conduct an unannounced, on-site investigation of a facility at any reasonable time, including when treatment services are provided, to inspect or investigate:

(1) a facility's compliance with any applicable statute or rule;

(2) a facility's plan of correction;

(3) a facility's compliance with an order of the executive commissioner or the executive commissioner's designee;

(4) a facility's compliance with a court order granting injunctive relief; or

(5) for other purposes relating to regulation of the facility.

(f) An applicant or licensee, by applying for or holding a license, consents to entry and investigation of any of its facilities by HHSC.

(g) A facility shall cooperate with any HHSC investigation and shall permit HHSC to examine the facility's grounds, buildings, books, records, and other documents and information maintained by, or on behalf of, the facility.

(h) A facility shall permit HHSC access to interview members of the governing body, personnel, and patients, including the opportunity to request a written statement.

(i) HHSC shall maintain the confidentiality of facility records as applicable under state and federal law.

(j) A facility shall permit HHSC to inspect and copy any requested information. If it is necessary for HHSC to remove documents or other records from the facility, HHSC provides a written description of the information being removed and when it is expected to be returned. HHSC makes a reasonable effort, consistent with the circumstances, to return any records removed in a timely manner.

(k) Upon entry, the HHSC representative holds an entrance conference with the facility's designated representative to explain the nature, scope, and estimated duration of the investigation.

(l) The HHSC representative holds an exit conference with the representative to inform the facility representative of any preliminary findings of the investigation. The facility may provide any final documentation regarding compliance during the exit conference.

(m) Once an investigation is complete, HHSC reviews the evidence from the investigation to evaluate whether there is a preponderance of evidence supporting the allegations contained in the complaint.

§509.84.Notice.

(a) A facility is deemed to have received any Texas Health and Human Services Commission (HHSC) correspondence on the date of receipt, or three business days after mailing, whichever is earlier.

(b) When HHSC finds deficiencies:

(1) HHSC provides the facility with a written Statement of Deficiencies (SOD) within 10 business days after the exit conference via U.S. Postal Service or electronic mail.

(2) Within 10 calendar days after the facility's receipt of the SOD, the facility shall return to HHSC a written Plan of Correction (POC) that addresses each cited deficiency, including timeframes for corrections, together with any additional evidence of compliance.

(A) HHSC determines if a POC and proposed timeframes are acceptable, and, if accepted, notifies the facility in writing.

(B) If HHSC does not accept the POC, HHSC notifies the facility in writing and requests the facility submit a modified POC and any additional evidence no later than 10 business days after HHSC notifies the facility in writing.

(C) The facility shall correct the identified deficiencies and submit to HHSC evidence verifying implementation of corrective action within the timeframes set forth in the POC, or as otherwise specified by HHSC.

(3) Regardless of the facility's compliance with this subsection or HHSC's acceptance of a facility's POC, HHSC may, at any time, propose to take enforcement action as appropriate under this chapter.

§509.85.Professional Conduct.

In addition to any enforcement action under this chapter, the Texas Health and Human Services Commission reports, in writing, to the appropriate licensing board any issue or complaint relating to the conduct of a licensed professional, intern, or applicant for professional licensure.

§509.86.Complaint Against an HHSC Representative.

A facility may register a complaint against a Texas Health and Human Services Commission (HHSC) representative who conducts an inspection or investigation under this subchapter by following the procedure listed on the HHSC website.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 29, 2023.

TRD-202302362

Karen Ray

Chief Counsel

Health and Human Services Commission

Earliest possible date of adoption: August 13, 2023

For further information, please call: (512) 834-4591

SUBCHAPTER E. ENFORCEMENT

26 TAC §§509.101 - 509.108

STATUTORY AUTHORITY

The new rules implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapter 254.

§509.101.Enforcement.

(a) Enforcement is a process by which a sanction is proposed, and if warranted, imposed on an applicant or licensee regulated by the Texas Health and Human Services Commission (HHSC) for failure to comply with applicable statutes, rules, and orders.

(b) HHSC has jurisdiction to enforce violations of the Act and this chapter.

(1) failure to comply with any applicable provision of Texas Health and Safety Code (HSC), including Chapter 254 (relating to Freestanding Emergency Medical Care Facilities);

(2) failure to comply with any provision of this chapter or any other applicable laws;

(3) the facility, or any of its employees, commits an act which causes actual harm or risk of harm to the health or safety of a patient;

(4) the facility, or any of its employees, materially alters any license issued by HHSC;

(5) failure to comply with minimum standards for licensure;

(6) failure to provide a complete license application;

(7) failure to comply with an order of the executive commissioner or another enforcement procedure under the Act;

(8) a history of failure to comply with the applicable rules relating to patient environment, health, safety, and rights;

(9) the facility aiding, committing, abetting, or permitting the commission of an illegal act;

(10) the facility, or any of its employees, committing fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to HHSC or required to be maintained by the facility pursuant to the Act and the provisions of this chapter;

(11) failure to timely pay an assessed administrative penalty as required by HHSC;

(12) failure to submit an acceptable plan of correction for cited deficiencies within the timeframe required by HHSC;

(13) failure to timely implement plans of corrections to deficiencies cited by HHSC within the dates designated in the plan of correction; or

(14) failure to comply with applicable requirements within a designated probation period.

(d) If HHSC proposes to deny, suspend, revoke a license, or impose an administrative penalty, HHSC shall send a notice of the proposed action by certified mail, return receipt requested, at the address shown in the current records of HHSC, or HHSC may personally deliver the notice. The notice to deny, suspend, or revoke a license, or impose an administrative penalty, shall state the alleged facts or conduct to warrant the proposed action, provide an opportunity to demonstrate or achieve compliance, and shall state that the applicant or license holder has an opportunity for a hearing before taking the action.

(e) Within 20 calendar days after receipt of the notice, the applicant or licensee may notify HHSC, in writing, of acceptance of HHSC's determination or request a hearing.

(f) A request for a hearing by the applicant or licensee shall be in writing and submitted to HHSC within 20 calendar days after receipt of the notice. Receipt of the notice is presumed to occur on the third day after the date HHSC mails the notice to the last known address of the applicant or licensee.

(1) A hearing shall be conducted pursuant to Government Code Chapter 2001 (relating to Administrative Procedure) and 1 TAC Chapter 357, Subchapter I (relating to Hearings Under the Administrative Procedure Act).

(2) If an applicant or licensee does not request a hearing in writing within 20 calendar days after receiving notice of the proposed action, the applicant or licensee is deemed to have waived the opportunity for a hearing and HHSC shall take the proposed action.

§509.102.Denial of a License.

The Texas Health and Human Services Commission (HHSC) has jurisdiction to enforce violations of the Act and this chapter. HHSC may deny a license if the applicant:

(1) fails to provide timely and sufficient information required by HHSC that is directly related to the application; or

(2) has had the following actions taken against the applicant within the two-year period preceding the application:

(A) decertification or cancellation of its contract under the Medicare or Medicaid program in any state;

(B) federal Medicare or state Medicaid sanctions or penalties;

(D) unsatisfied final judgments;

(E) eviction involving any property or space used as a freestanding emergency medical care (FEMC) facility in any state;

(F) unresolved federal Medicare or state Medicaid audit exceptions;

(G) denial, suspension, or revocation of an FEMC facility license, a hospital license, a private psychiatric hospital license, or a license for any health care facility in any state; or

(H) a court injunction prohibiting ownership or operation of a facility.

§509.103.Suspension; Revocation.

(a) The Texas Health and Human Services Commission (HHSC) may deny a person or entity a license or suspend or revoke an existing license on the grounds that the person or entity has been convicted of a felony or misdemeanor that directly relates to the duties and responsibilities of the ownership or operation of a facility.

(b) In determining whether a criminal conviction directly relates, HHSC shall apply the requirements and consider the provisions of Texas Occupations Code Chapter 53 (relating to Consequences of Criminal Conviction).

(c) The following felonies and misdemeanors directly relate to the duties and responsibilities of the ownership or operation of a health care facility because these criminal offenses indicate an ability or a tendency for the person to be unable to own or operate a facility:

(1) a misdemeanor violation of the Act;

(2) a misdemeanor or felony involving moral turpitude;

(3) a misdemeanor or felony relating to deceptive business practices;

(4) a misdemeanor or felony of practicing any health-related profession without a required license;

(5) a misdemeanor or felony under any federal or state law relating to drugs, dangerous drugs, or controlled substances;

(6) a misdemeanor or felony under Texas Penal Code (TPC) Title 5, involving a patient or a client of any health care facility, a home and community support services agency or a health care professional;

(7) a misdemeanor or felony under TPC:

(A) Title 4, concerning offenses of attempting or conspiring to commit any of the offenses in this paragraph;

(B) Title 5, concerning offenses against the person;

(D) Title 8, concerning offenses against public administration;

(E) Title 9, concerning offenses against public order and decency;

(F) Title 10, concerning offenses against public health, safety, and morals; or

(G) Title 11, concerning offenses involving organized crime.

(8) Offenses listed in this subsection are not exclusive in that HHSC may consider similar criminal convictions from other state, federal, foreign, or military jurisdictions that indicate an inability or tendency for the person or entity to be unable to own or operate a facility.

(d) HHSC shall revoke a license on the licensee's imprisonment following a felony conviction, felony community supervision revocation, revocation of parole, or revocation of mandatory supervision.

§509.104.Emergency Suspension.

(a) The Texas Health and Human Services Commission (HHSC) may issue an emergency order to suspend a facility's license issued under this chapter, if HHSC has reasonable cause to believe that the conduct of a license holder creates an immediate danger to public health and safety.

(b) An emergency suspension under this section is effective immediately without a hearing on notice to the license holder.

(c) On written request of the license holder to HHSC for a hearing, HHSC shall refer the matter to the State Office of Administrative Hearings. An administrative law judge of the office shall conduct a hearing, not earlier than the 10th day or later than the 30th day after the date HHSC receives the hearing request, to determine if the emergency suspension is to be continued, modified, or rescinded.

(d) A hearing and any appeal under this section are governed by HHSC rules for a contested case hearing and Texas Government Code Chapter 2001 (relating to Administrative Procedure).

§509.105.Probation.

(a) If the Texas Health and Human Services Commission (HHSC) finds that a facility is in repeated noncompliance with the Act or this chapter but that the noncompliance does not endanger public health and safety, HHSC may place the facility on probation rather than suspending or revoking the facility's license.

(b) HHSC shall provide notice to the facility of the probation and of the items of noncompliance not later than the 10th day before the date the probation period begins.

(d) During the probation period, the facility shall correct the items of noncompliance and report the corrections to HHSC for approval.

(e) HHSC may verify the corrective actions through an on-site inspection.

(f) HHSC may suspend or revoke the license of a facility that does not correct items of noncompliance or that does not comply with the Act or this chapter within the applicable probation period.

§509.106.Injunction.

Pursuant to Texas Health and Safety Code §254.203 (relating to Injunction), the Texas Health and Human Services Commission (HHSC) may petition a district court for a temporary restraining order to restrain a continuing violation of the standards or licensing requirements provided under the Act or Texas Health and Safety Code Section 254.158 (relating to Removal of Signs) if HHSC finds that the violation creates an immediate threat to the health and safety of the patients of a facility or of the public.

§509.107.Administrative Penalty.

(a) The Texas Health and Human Services Commission (HHSC) may impose an administrative penalty on a person licensed under the Act who violates the Act, this chapter, or an order adopted under this chapter.

(b) The amount of the penalty may not exceed $1,000 for each violation. Each day a violation continues or occurs is a separate violation for purposes of imposing a penalty.

(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;

(2) the threat to health or safety caused by the violation;

(3) the history of previous violations;

(4) the amount necessary to deter a future violation;

(5) whether the violator demonstrated good faith efforts to come into compliance; and

(6) any other matter that justice may require.

(d) If HHSC initially determines that a violation occurred, HHSC shall give written notice of the report by certified mail to the person.

(e) The notice under subsection (d) of this section shall include:

(1) a brief summary of the alleged violation;

(2) a statement of the amount of the recommended penalty; and

(3) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both.

(f) Within 20 calendar days after the date the person receives the notice under subsection (d) of this section, the person in writing may:

(1) accept the determination and recommended penalty of HHSC; or

(2) make a request for a hearing on the occurrence of the violation, the amount of the penalty, or both.

(g) If the person accepts the determination and recommended penalty or if the person fails to respond to the notice, the executive commissioner or the executive commissioner's designee by order shall approve the determination and impose the recommended penalty.

(h) If the person requests a hearing, the executive commissioner shall refer the matter to the State Office of Administrative Hearings (SOAH), which will set the hearing date. HHSC shall give written notice of the time and place of the hearing to the person. An administrative law judge with SOAH will conduct the hearing.

(i) The administrative law judge will make findings of fact and conclusions of law and issue to the executive commissioner a proposal for a decision about the occurrence of the violation and the amount of a proposed penalty.

(j) Based on the findings of fact, conclusions of law, and proposal for a decision, the executive commissioner by order may:

(1) find that a violation occurred and impose a penalty; or

(2) find that a violation did not occur.

(k) The notice of the order under subsection (j) of this section that HHSC sends to the person in accordance with Texas Government Code Chapter 2001 (relating to Administrative Procedure) must include a statement of the right of the person to judicial review of the order.

§509.108.Payment of Administrative Penalty; Judicial Review.

(a) Within 30 calendar days after the date an order of the executive commissioner under §509.107(k) of this subchapter (relating to Administrative Penalty) that imposes an administrative penalty becomes final, the person shall:

(1) pay the penalty; or

(2) pursuant to Texas Health and Safety Code (HSC) §254.206 (relating to Payment and Collection of Administrative Penalty; Judicial Review), file a petition for judicial review of the executive commissioner's order contesting the occurrence of the violation, the amount of the penalty, or both.

(b) Within the 30-day period prescribed by subsection (a) of this section, a person who files a petition for judicial review may:

(1) stay enforcement of the penalty by:

(A) paying the penalty to the court for placement in an escrow account; or

(B) giving the court a supersedeas bond that is approved by the court for the amount of the penalty, and that is effective until all judicial review of the commissioner's order is final; or

(2) request the court to stay enforcement of the penalty by:

(A) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(B) sending a copy of the affidavit to the executive commissioner by certified mail.

(3) If the executive commissioner receives a copy of an affidavit under paragraph (2)(B) of this subsection, the executive commissioner may file with the court, within five days after the date the copy is received, a contest to the affidavit. In accordance with HSC §254.206(c), the court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(c) If the person does not pay the penalty and the enforcement of the penalty is not stayed, HHSC may refer the matter to the attorney general for collection of the penalty. As provided by HSC §254.206(d), the attorney general may sue to collect the penalty.

(d) A decision by the court is governed by HSC §254.206(e) and (f) and provides the following.

(1) If the court sustains the finding that a violation occurred, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty.

(2) If the court does not sustain the finding that a violation occurred, the court shall order that a penalty is not owed.

(e) The remittance of penalty and interest is governed by HSC §254.206(g) and provides the following.

(1) If the person paid the penalty and if the amount of the penalty is reduced or the penalty is not upheld by the court, the court shall order, when the court's judgment becomes final, that the appropriate amount plus accrued interest be remitted to the person within 30 days after the date that the judgment of the court becomes final.

(2) The interest accrues at the rate charged on loans to depository institutions by the New York Federal Reserve Bank.

(3) The interest shall be paid for the period beginning on the date the penalty is paid and ending on the date the penalty is remitted.

(f) The release of supersedeas bond is governed by HSC §254.206(h) and provides the following.

(1) If the person gave a supersedeas bond and the court does not uphold the penalty, the court shall order, when the court's judgment becomes final, the release of the bond.

(2) If the person gave a supersedeas bond and the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the reduced amount.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on June 29, 2023.

TRD-202302363

Karen Ray

Chief Counsel

Health and Human Services Commission

Earliest possible date of adoption: August 13, 2023

For further information, please call: (512) 834-4591