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.
Cont'd... |
