26 Tex. Admin. Code § 504.2 - Definitions

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

(1) Abortion--The act of using or prescribing an instrument, a drug, a medicine, or any other substance, device, or means with the intent to cause the death of an unborn child of a woman known to be pregnant. The term does not include birth control devices or oral contraceptives. An act is not an abortion if the act is done with the intent to save the life or preserve the health of an unborn child; remove a dead, unborn child whose death was caused by spontaneous abortion; or remove an ectopic pregnancy.

(2) Abortion complication or adverse event--Any harmful event or adverse outcome with respect to a patient related to an abortion that is performed on the patient or induced and that is diagnosed or treated by a health care practitioner or at a health care facility, including:

(A) shock;

(B) uterine perforation;

(C) cervical laceration;

(D) hemorrhage;

(E) aspiration or allergic response;

(F) infection;

(G) sepsis;

(H) death of the patient;

(I) incomplete abortion;

(J) damage to the uterus;

(K) an infant born alive after the abortion;

(L) blood clots resulting in pulmonary embolism or deep vein thrombosis;

(M) failure to actually terminate the pregnancy;

(N) pelvic inflammatory disease;

(O) endometritis;

(P) missed ectopic pregnancy;

(Q) cardiac arrest;

(R) respiratory arrest;

(S) renal failure;

(T) metabolic disorder;

(U) embolism;

(V) coma;

(W) placenta previa in subsequent pregnancies;

(X) preterm delivery in subsequent pregnancies;

(Y) fluid accumulation in the abdomen;

(Z) hemolytic reaction resulting from the administration of ABO-incompatible blood or blood products;

(AA) adverse reactions to anesthesia or other drugs; or

(BB) any other adverse event as defined by the United States Food and Drug Administration's criteria provided by MedWatch Reporting System.

(3) Abortion facility--A place where abortions are performed or induced.

(4) Abortion-inducing drug--A drug, medicine, or any other substance, including a regimen of two or more drugs, medicines, or substances, prescribed, dispensed, or administered with the intent of terminating a clinically diagnosable pregnancy of a woman and with knowledge that the termination will, with reasonable likelihood, cause the death of the woman's unborn child. The term includes off-label use of drugs, medicines, or other substances known to have abortion-inducing properties that are prescribed, dispensed, or administered with the intent of causing an abortion, including the Mifeprex regimen, misoprostol (Cytotec), and methotrexate. The term does not include a drug, medicine, or other substance that may be known to cause an abortion but is prescribed, dispensed, or administered for other medical reasons.

(5) Act--Texas Abortion Facility Reporting and Licensing Act, Health and Safety Code Chapter 245.

(6) Administrator--A person who:

(A) is delegated the responsibility for the implementation and proper application of policies, programs, and services established for the licensed abortion facility; and

(B) meets the qualifications established in § 139.46(2) of this chapter (relating to Licensed Abortion Facility Staffing Requirements and Qualifications).

(7) Advanced practice registered nurse (APRN)--A registered nurse approved by the Texas Board of Nursing to practice as an advanced practice registered nurse on the basis of completion of an advanced educational program. The term includes a nurse practitioner, nurse midwife, nurse anesthetist, and clinical nurse specialist. The term is synonymous with "advanced nurse practitioner."

(8) Affidavit--A written statement, sworn to or affirmed, and witnessed by a witness whose signature and printed name appears on the affidavit. "Notarized affidavit" in these rules means an affidavit in which the statement is witnessed by a notary acting pursuant to Government Code Chapter 406.

(9) Affiliate--With respect to an applicant or owner which is:

(A) a corporation--includes each officer, consultant, stockholder with a direct ownership of at least 5.0%, subsidiary, and parent company;

(B) a limited liability company--includes each officer, member, and parent company;

(C) an individual--includes:

(i) the individual's spouse;

(ii) each partnership and each partner thereof of which the individual or any affiliate of the individual is a partner; and

(iii) each corporation in which the individual is an officer, consultant, or stockholder with a direct ownership of at least 5.0%;

(D) a partnership--includes each partner and any parent company; and

(E) a group of co-owners under any other business arrangement--includes each officer, consultant, or the equivalent under the specific business arrangement and each parent company.

(10) Applicant--The owner of an abortion facility which is applying for a license under the Act. For the purpose of this chapter, the word "owner" includes nonprofit organization.

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

(12) Change of ownership--A sole proprietor who transfers all or part of the facility's ownership to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a facility owned by a partnership; or a corporate sale, transfer, reorganization, or merger of the corporation which owns the facility if sale, transfer, reorganization, or merger causes a change in the facility's ownership to another person or persons.

(13) Commission--The Texas Health and Human Services Commission.

(14) Condition on discharge--A statement on the condition of the patient at the time of discharge.

(15) Critical item--All surgical instruments and objects that are introduced directly into the bloodstream or into other normally sterile areas of the body.

(16) Decontamination--The physical and chemical process that renders an inanimate object safe for further handling.

(17) Department--The Department of State Health Services.

(18) Director--The director of the Health Care Regulation Department of HHSC or their designee.

(19) Disinfection--The destruction or removal of vegetative bacteria, fungi, and most viruses but not necessarily spores; the process does not remove all organisms but reduces them to a level that is not harmful to a person's health. There are three levels of disinfection:

(A) high-level disinfection--kills all organisms, except high levels of bacterial spores, and is effected with a chemical germicide cleared for marketing as a sterilant by the United States Food and Drug Administration;

(B) intermediate-level disinfection--kills mycobacteria, most viruses, and bacteria with a chemical germicide registered as a "tuberculocide" by the United States Environmental Protection Agency (EPA); and

(C) low-level disinfection--kills some viruses and bacteria with a chemical germicide registered as a hospital disinfectant by the EPA.

(20) Ectopic pregnancy--The implantation of a fertilized egg or embryo outside of the uterus.

(21) Education and information staff--A professional or nonprofessional person who is trained to provide information on abortion procedures, alternatives, informed consent, and family planning services.

(22) Embryonic and fetal tissue remains--An embryo, a fetus, body parts, or organs from a pregnancy that terminates in the death of the embryo or fetus and for which the issuance of a fetal death certificate is not required by state law. The term does not include the umbilical cord, placenta, gestational sac, blood, or body fluids.

(23) Executive Commissioner--The Executive Commissioner of the Texas Health and Human Services Commission.

(24) Facility--A licensed abortion facility as defined in this section.

(25) Fetus--An individual human organism from fertilization until birth.

(26) Health care facility--Any type of facility or home and community support services agency licensed to provide health care in any state or is certified for Medicare (Title XVIII) or Medicaid (Title XIX) participation in any state.

(27) Health care worker--Any person who furnishes health care services in a direct patient care situation under a license, certificate, or registration issued by the State of Texas or a person providing direct patient care in the course of a training or educational program.

(28) Hospital--A facility that is licensed under the Texas Hospital Licensing Law, Health and Safety Code Chapter 241, or if exempt from licensure, certified by the United States Department of Health and Human Services as in compliance with the conditions of participation for hospitals in Title XVIII, Social Security Act (42 United States Code §§ 1395 et. seq.).

(29) Immediate jeopardy to health and safety--A situation in which there is a high probability that serious harm or injury to patients could occur at any time or already has occurred and may well occur again, if patients are not protected effectively from the harm or if the threat is not removed.

(30) Inspection--An on-site inspection by HHSC in which a standard-by-standard evaluation is conducted.

(31) Licensed abortion facility--A place licensed by HHSC under Health and Safety Code Chapter 245, where abortions are performed or induced.

(32) Licensed mental health practitioner--A person licensed in the State of Texas to provide counseling or psychotherapeutic services.

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

(34) Licensee--A person or entity who is currently licensed as an abortion facility.

(35) Medical abortion--The administration or use of an abortion-inducing drug to induce an abortion, and may also be referred to as a "medication abortion," a "chemical abortion," a "drug-induced abortion," "RU-486," or the "Mifeprex regimen."

(36) Medical consultant--A physician who is designated to supervise the medical services of the facility.

(37) Nonprofessional personnel--Personnel of the facility who are not licensed or certified under the laws of this state to provide a service and shall function under the delegated authority of a physician, registered nurse, or other licensed health professional who assumes responsibility for their performance in the licensed abortion facility.

(38) Noncritical items--Items that come in contact with intact skin.

(39) Notarized copy--A copy attached to a notarized affidavit which states that the attached copy(ies) are true and correct copies of the original documents.

(40) Patient--A pregnant female on whom an abortion is performed or induced, but shall in no event be construed to include a fetus.

(41) Person--Any individual, firm, partnership, corporation, or association.

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

(43) Physician assistant--A person licensed as a physician assistant by the Texas Physician Assistant Board.

(44) Plan of correction--A written strategy for correcting a licensing violation. The plan of correction shall be developed by the facility, and shall address the systemic operation(s) of the facility as the systemic operation(s) apply to the deficiency.

(45) Post-procedure infection--An infection acquired at or during an admission to a facility; there shall be no evidence that the infection was present or incubating at the time of admission to the facility. Post-procedure infections and their complications that may occur after an abortion include, but are not limited to, endometritis and other infections of the female reproductive tract, laboratory-confirmed or clinical sepsis, septic pelvic thrombophlebitis, and disseminated intravascular coagulopathy.

(46) Pregnant unemancipated minor certification form--The document prepared by HHSC and used by physicians to certify the medical indications supporting the judgment for the immediate abortion of a pregnant minor.

(47) Pre-inspection conference--A conference held with HHSC staff and the applicant or his or her representative to review licensure standards, inspection documents, and provide consultation prior to the on-site licensure inspection.

(48) Professional personnel--Patient care personnel of the facility currently licensed or certified under the laws of this state to use a title and provide the type of service for which the patient care personnel are licensed or certified.

(49) Quality assurance--An ongoing, objective, and systematic process of monitoring, evaluating, and improving the appropriateness, and effectiveness of care.

(50) Quality improvement--An organized, structured process that selectively identifies improvement projects to achieve improvements in products or services.

(51) Registered nurse (RN)--A person who is currently licensed by the Texas Board of Nursing as a registered nurse.

(52) Semicritical items--Items that come in contact with nonintact skin or mucous membranes. Semicritical items may include respiratory therapy equipment, anesthesia equipment, bronchoscopes, and thermometers.

(53) Standards--Minimum requirements under the Act and this chapter.

(54) Sterile field--The operative area of the body and anything that directly contacts this area.

(55) Sterilization--The use of a physical or chemical procedure to destroy all microbial life, including bacterial endospores.

(56) Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity that includes initial direction and periodic inspection of the actual act of accomplishing the function or activity.

(57) Surgical abortion--The use of instruments, aspiration, and/or suction to induce an abortion, with the purpose of terminating the pregnancy of a woman known to be pregnant.

(58) Third trimester certification form--The document prepared by HHSC and used by physicians to certify the medical indications supporting the judgment for the abortion of a viable fetus during the third trimester of pregnancy.

(59) Third trimester--A gestational period of not less than 26 weeks (following last-menstrual period (LMP)).

(60) Unemancipated minor--A minor who is unmarried and has not had the disabilities of minority removed under Family Code Chapter 31.

Notes

26 Tex. Admin. Code § 504.2

Transferred from 25 TAC § 139.2 Texas Register, Volume 49, Number 50, December 13, 2024, TexReg 10119 eff. 12/31/2024