TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 139. ABORTION FACILITY REPORTING AND LICENSING

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC) proposes amendments to §139.2, concerning Definitions; §139.4, concerning Monthly Reporting Requirements for All Abortions Performed; §139.5, concerning Additional Reporting Requirements; §139.32, concerning License Denial, Suspension, Probation, or Revocation; §139.50, concerning Disclosure Requirements; §139.52, concerning Patient Education/Information Services; §139.53, concerning Medical and Clinical Services; and §139.55, concerning Clinical Records.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with Senate Bill (S.B.) 8, 87th Legislature, 2021, Regular Session, and S.B. 4, 87th Legislature, 2021, Second Called Session. S.B. 8 requires physicians who perform an abortion on or after September 1, 2021, to maintain certain documentation regarding the reasons for an abortion and prohibits HHSC from enforcing Texas Health and Safety Code (HSC) Chapter 171, Subchapter H, concerning Detection of Fetal Heartbeat. S.B. 4 amends abortion complication reporting requirements and requirements for providing abortion-inducing drugs for abortions performed on or after December 2, 2021. The proposal is also necessary to remove outdated information and ensure consistency with current HHSC terminology.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §139.2 updates and adds definitions for consistency with S.B. 8 and S.B. 4 and makes non-substantive updates to ensure consistency with current HHSC terminology.

The proposed amendments to §139.4 and §139.5 update these sections to comply with S.B. 4 and S.B. 8, clarify a report under this section must include information as required by the online electronic reporting system, and remove outdated language regarding reporting procedures prior to the establishment of the online system. The proposed amendments to this section also replace the term "commission" with "HHSC" and make other non-substantive updates to increase consistency with current HHS rule drafting guidelines.

The proposed amendment to §139.32 adds language to comply with S.B. 8, which prohibits HHSC from enforcing HSC Chapter 171, Subchapter H, replaces "department" with "HHSC" to reflect the transition of regulatory authority under this chapter from the Department of State Health Services (DSHS) to HHSC, removes a redundant paragraph, updates internal references, and makes non-substantive edits to increase consistency with HHS rule drafting guidelines.

The proposed amendment to §139.50 updates language for consistency with S.B. 4, updates language for submitting complaints to HHSC, and replaces "department" with "HHSC" to reflect the transition of regulatory authority under this chapter from DSHS to HHSC.

The proposed amendment to §139.52 removes Figure: 25 TAC §139.52(a)(1) and updates language regarding the required informed consent form required under HSC §171.012.

The proposed amendment to §139.53 clarifies the written consent obtained must be in accordance with §139.50 of this chapter to ensure consistency with S.B. 4's provisions and makes non-substantive edits to increase consistency with HHS rule drafting guidelines.

The proposed amendment to §139.55 updates the section for consistency with S.B. 8 and replaces the reference to "department" with HHSC to reflect the transition of regulatory authority under this chapter from DSHS to HHSC. The proposed amendment also removes outdated information related to abortion reporting, as this information is now reported monthly and electronically.

FISCAL NOTE

Trey Wood, 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 do not have foreseeable implications relating to costs or revenues of state or local governments.

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 not affect fees paid to HHSC;

(5) the proposed rules will not create a new rule;

(6) the proposed rules will expand existing rules;

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

(8) HHSC has insufficient information to determine the proposed rules' effect on the state's economy.

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

Trey Wood has also determined that there will be an adverse economic effect on small businesses or micro-businesses, or rural communities.

HHSC is unable to provide an estimate of the number of small businesses and micro businesses affected by S.B. 8 or S.B. 4. The proposed rules related to S.B. 8 and S.B. 4's provisions regarding provision of an abortion-inducing drug apply to abortion facilities, which include abortion facilities licensed under HSC Chapter 245 and ambulatory surgical centers (ASCs) and general and special hospitals where abortions are performed. There are approximately a total of 26 licensed abortion facilities and ASCs where an abortion may be performed and approximately 646 licensed general and special hospitals.

The proposed rules related to S.B. 4's complication reporting provisions apply to the facilities that diagnose or treat an abortion complication or adverse event which may include licensed abortion facilities, ASCs, general and special hospitals, and freestanding emergency medical care facilities. A total of 1,450 businesses are licensed under these categories.

HHSC is adopting and implementing these rules to comply with statutes and has no regulatory flexibility regarding their adoption.

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; and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.

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 publicly accessible information consistent with statutory requirements for physician documentation, abortion complication reporting, and drug-induced abortion requirements, which will likely enhance the health and safety of Texans across the state.

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 will incur economic costs because there are costs expected for updating the required abortion sonogram and election forms and for developing or purchasing training and for training staff on the new requirements of S.B. 4 and S.B. 8. HHSC is unable to provide an estimate regarding the specific costs to entities to comply with the rules as proposed.

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 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_PRT@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 22R024" in the subject line.

SUBCHAPTER A. GENERAL PROVISIONS

25 TAC §§139.2, 139.4, 139.5

STATUTORY AUTHORITY

The amendments 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 Texas Health and Safety Code §171.006, which authorizes HHSC to adopt rules regarding abortion complication reporting, and §§245.009 -245.010, which require HHSC to adopt rules necessary to implement Chapter 245, including rules to protect the health and safety of a patient of an abortion facility, and provisions requiring compliance with Chapter 171, Subchapter B.

The amendments are necessary to implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapters 171 and 245.

§139.2.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 abortion may be performed only by a physician licensed to practice medicine in this state.] 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; [or]

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

(6) [(5)] 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 [title] (relating to Licensed Abortion Facility Staffing Requirements and Qualifications).

(7) [(6)] 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) [(7)] 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) [(8)] 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) [(9)] 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) [(10)] 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) [(11)] 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) [(12)] Commission--The Texas Health and Human Services Commission.

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

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

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

(17) [(16)] Department--The Department of State Health Services.

(18) [(17)] Director--The director of the Health Care Regulation [Quality] Department of HHSC [the commission] or their [his or her] designee.

(19) [(18)] 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) [(19)] Ectopic pregnancy--The implantation of a fertilized egg or embryo outside of the uterus.

(21) [(20)] 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) [(21)] 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) [(22)] Executive Commissioner--The Executive Commissioner of the Texas Health and Human Services Commission.

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

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

(26) [(25)] 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) [(26)] 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) [(27)] 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) [(28)] 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) [(29)] Inspection--An on-site inspection by HHSC [the commission] in which a standard-by-standard evaluation is conducted.

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

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

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

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

(35) [(34)] Medical abortion--The administration or use of a medication or combination of medications to induce an abortion, with the purpose of terminating the pregnancy of a woman known to be pregnant. Medical abortion does not include forms of birth control. A medical abortion may also be referred to as a "medication abortion," a "chemical abortion," a "drug-induced abortion," "RU-486," or the "Mifeprex regimen."

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

(37) [(36)] 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) [(37)] Noncritical items--Items that come in contact with intact skin.

(39) [(38)] 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) [(39)] Patient--A pregnant female on whom an abortion is performed or induced, but shall in no event be construed to include a fetus.

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

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

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

(44) [(43)] 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) [(44)] 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) [(45)] Pregnant unemancipated minor certification form--The document prepared by HHSC [the commission] and used by physicians to certify the medical indications supporting the judgment for the immediate abortion of a pregnant minor.

(47) [(46)] Pre-inspection conference--A conference held with HHSC [commission] 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) [(47)] 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 [they] are licensed or certified.

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

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

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

(52) [(51)] 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) [(52)] Standards--Minimum requirements under the Act and this chapter.

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

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

(56) [(55)] 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) [(56)] 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) [(57)] Third trimester certification form--The document prepared by HHSC [the commission] 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) [(58)] Third trimester--A gestational period of not less than 26 weeks (following last-menstrual period (LMP)).

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

§139.4.Monthly Reporting Requirements for All Abortions Performed or Induced.

(a) The purpose of this section is to implement the monthly abortion reporting requirements under Health and Safety Code (HSC) §245.011 for physicians who perform or induce one or more abortions during the preceding calendar month. A report must be submitted for each abortion performed or induced.

(b) The report may not identify by any means the patient.

(c) The report must include all information the Texas Health and Human Services Commission (HHSC) requires through its secure electronic reporting system in accordance with HSC Chapters 171 and 245.[:]

[(1) whether the abortion facility at which the abortion is performed is licensed under this chapter;]

[(2) the patient's year of birth, race, marital status, and state and county of residence;]

[(3) the type of abortion procedure;]

[(4) the date the abortion was performed;]

[(5) whether the patient survived the abortion, and if the patient did not survive, the cause of death;]

[(6) the probable post-fertilization age of the unborn child based on the best medical judgment of the attending physician at the time of the procedure;]

[(7) the date, if known, of the patient's last menstrual cycle;]

[(8) the number of previous live births of the patient;]

[(9) the number of previous induced abortions of the patient;]

[(10) whether the patient viewed the printed material provided under Health and Safety Code, Chapter 171;]

[(11) whether the sonogram image, verbal explanation of the image, and the audio of the heart sounds were made available to the patient;]

[(12) whether the patient completed the "Abortion and Sonogram" election form;]

[(13) the method used to dispose of embryonic and fetal tissue remains;]

[(14) if the patient is younger than 18 years of age, as documented in the patient's medical record, whether authorization for the abortion was obtained by:]

[(A) written consent of the patient's parent, managing conservator, or legal guardian under Occupations Code, §164.052(a)(19) and whether the consent was given:]

[(i) in person at the location where the abortion was performed; or]

[(ii) at a place other than the location where the abortion was performed;]

[(B) judicial authorization under Family Code, §33.003 or §33.004 and:]

[(i) if applicable, the process the physician or physician's agent used to inform the patient of the availability of petitioning for judicial authorization as an alternative to the written consent required by Occupations Code, §164.052(a)(19);]

[(ii) whether the court forms were provided to the patient by the physician or the physician's agent;]

[(iii) whether the physician or the physician's agent made arrangements for the patient's court appearance; and]

[(iv) if known, whether the patient became pregnant while in foster care or in the managing conservatorship of the Department of Family and Protective Services;]

[(C) consent of the patient because the patient had the disabilities of minority removed; or]

[(D) the physician's conclusion, documented in the patient's medical record, that on the basis of the physician's good-faith clinical judgment:]

[(i) a condition existed that complicated the medical condition of the patient and necessitated the immediate abortion to avert the patient's death or to avoid a serious risk of substantial impairment of a major bodily function; and]

[(ii) there was insufficient time to obtain the consent of the patient's parent, managing conservator, or legal guardian;]

[(15) the method of pregnancy verification; and]

[(16) the type of anesthesia, if any, used in the procedure: intravenous sedation or general anesthesia.]

(d) Except as provided by HSC [Health and Safety Code,] §245.023, all information and records held by HHSC [the commission or the department] under this chapter are confidential and are not open records for the purposes of Government Code[,] Chapter 552. That information may not be released or made public on subpoena, or otherwise, except that release may be made:

(1) for statistical purposes, but only if a person, patient, physician performing or inducing an abortion, the county in which a minor obtained judicial authorization for an abortion under Family Code Chapter 33, [Family Code,] or abortion facility is not identified;

(2) with the consent of each person, patient, physician, and abortion facility identified in the information released;

(3) to medical personnel, appropriate state agencies, or county and district courts to enforce this chapter;

(4) to appropriate state licensing boards to enforce state licensing laws; or

(5) to licensed medical or health care personnel currently treating the patient.

(e) The reporting period for each physician is the preceding calendar month in which the physician performed or induced one or more abortions. Each physician who performs or induces one or more abortions shall submit the abortion report(s) to HHSC [the commission] no later than the 15th day of the subsequent month.

(f) The abortion reports shall be submitted via the [a] secure electronic reporting system established and maintained by HHSC. [the commission. Until this system is established, the abortion reports shall be submitted on forms approved by the commission, by certified mail marked as confidential, to the Department of State Health Services, Vital Statistics Unit, Post Office Box 4124, Austin, Texas 78765-4124.]

(g) Not later than the seventh day after the date the report required by this section is due, HHSC [the commission] shall notify the Texas Medical Board of a violation of this section.

(h) HHSC [The commission] shall publish on its Internet website a monthly report containing aggregate data of the information in the reports submitted under this section. HHSC's [The commission's] monthly report may not identify by any means an abortion facility, a physician performing or inducing an abortion, the county in which a minor obtained judicial authorization for an abortion under [Chapter 33 of the] Family Code Chapter 33, or a patient.

§139.5.Additional Reporting Requirements.

In addition to the annual reporting required by §139.4 of this subchapter [title] (relating to Monthly Reporting Requirements for All Abortions Performed or Induced), physicians and health care facilities subject to this chapter shall comply with this section when performing or inducing third trimester abortions, when performing or inducing emergency abortions, and when diagnosing or treating abortion complications.

(1) Reporting requirements for third trimester abortions.

(A) The purpose of this paragraph is to establish procedures for reporting third trimester abortions as required by the Medical Practice Act, Occupations Code[,] Chapters 151 - 160[,] and 162 - 165.

(B) A physician who performs or induces a third trimester abortion of a viable fetus with a biparietal diameter of 60 millimeters or greater shall certify in writing to the Texas Health and Human Services Commission (HHSC) [commission] the medical indications supporting the physician's judgment that the abortion is either necessary to prevent the death or a substantial risk of serious impairment to the physical or mental health of the woman, or the fetus has a severe and irreversible abnormality, as identified through reliable diagnostic procedures.

(C) The certification shall be made on a form approved by HHSC [the commission].

(D) The certification form and any supporting documents shall be submitted via the [a] secure electronic reporting system established and maintained by HHSC. [the commission. Until this system is established, the certification form and any supporting documents shall be submitted to the Department of State Health Services, Vital Statistics Unit, Post Office Box 4124, Austin, Texas 78765-4124, not later than the 30th day after the date the abortion was performed.]

(E) HHSC [The commission] shall retain the certification form and supporting documents as a cross-reference to the annual reporting requirements of the Act and this section. The certification form and supporting documents retained by HHSC [the commission] are confidential. Any release of the documents shall be in accordance with the provisions of the Medical Practice Act, Occupations Code[,] Chapters 151 - 160[,] and 162 - 165.

(F) A physician performing or inducing abortions at a licensed abortion facility who fails to submit the certification form required under this paragraph may subject the licensed facility to denial, suspension, probation, or revocation of the license in accordance with §139.32 of this chapter [title] (relating to License Denial, Suspension, Probation, or Revocation).

(2) Reporting requirements for emergency abortions.

(A) The purpose of this paragraph is to establish procedures for reporting emergency abortions performed or induced as authorized by Family Code[,] §33.002, Health and Safety Code[,] §171.0124, and Health and Safety Code[,] §285.202.

(B) A physician who performs or induces an emergency abortion shall certify in writing to HHSC [the commission] that a medical emergency exists.

(C) The certification shall be made on a form approved by HHSC [the commission].

(D) The certification form shall be submitted via the [a] secure electronic reporting system established and maintained by HHSC. [the commission. Until this system is established, the certification form shall be submitted to the Department of State Health Services, Vital Statistics Unit, Post Office Box 4124, Austin, Texas 78765-4124 not later than 30 days after the date the abortion was performed.]

(E) A physician performing or inducing abortions at a licensed abortion facility who fails to submit the certification form required by this paragraph may subject the licensed facility to denial, suspension, probation, or revocation of the license in accordance with §139.32 of this chapter [title].

(3) Reporting requirements for abortion complications.

(A) Within three business days after the date the complication is diagnosed or treated, a physician shall submit to HHSC [the commission] an abortion complication report.

(B) Within 30 calendar days after the date the complication is diagnosed or treated, a hospital, abortion facility, freestanding emergency medical care facility, or health care facility that provides emergency medical care as defined by Health and Safety Code[,] §773.003 shall submit to HHSC [the commission] an abortion complication report.

(C) The certification form shall be submitted via the [a] secure electronic reporting system established and maintained by HHSC. [the commission. Until this system is established, the certification form shall be submitted to the Department of State Health Services, Vital Statistics Unit, Post Office Box 4124, Austin, Texas 78765-4124.]

(D) A report submitted under this paragraph may not identify the physician who performed or induced the abortion, other than the reporting physician, or the patient.

(E) The report must include all information HHSC requires through its secure electronic reporting system in accordance with Health and Safety Code Chapters 171 and 245. [identify the name of the physician submitting the report or the name and type of health care facility submitting the report, must include the most specific, accurate, and complete reporting for the highest level of specificity, and must include, if known:]

[(i) the date of the abortion that caused or may have caused the complication;]

[(ii) the type of abortion that caused or may have caused the complication;]

[(iii) the name and type of facility where the abortion was performed;]

[(iv) the name, date and type of facility where the complication was diagnosed and treated;]

[(v) description of complications;]

[(vi) the number of weeks of gestation at which the abortion was performed;]

[(vii) the number of previous live births of the patient;]

[(viii) the number of previous induced abortions of the patient;]

[(ix) the type of anesthesia, if any, used in the procedure: intravenous sedation or general anesthesia;]

[(x) the patient's year of birth, race, marital status, and state and county of residence; and]

[(xi) the date of the first date of the patient's last menstrual period that occurred before the date of the abortion that caused or may have caused the complication.]

(F) HHSC [The commission] shall notify the Texas Medical Board of a violation of this paragraph by a physician.

(G) HHSC [The commission] shall publish on its Internet website an annual report containing aggregate data of the information in the reports submitted under this paragraph for the previous calendar year. The annual report may not include any duplicative data and may not identify by any means an abortion facility, a physician, or a patient.

(H) The third separate violation of this paragraph by a facility required to report under subparagraph (B) of this paragraph constitutes cause for the revocation or suspension of the facility's license, permit, registration, certificate, or other authority or for other disciplinary action against the facility.

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 April 22, 2022.

TRD-202201563

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: June 5, 2022

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


SUBCHAPTER C. ENFORCEMENT

25 TAC §139.32

STATUTORY AUTHORITY

The amendment is 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 Texas Health and Safety Code §171.006, which authorizes HHSC to adopt rules regarding abortion complication reporting, and §§245.009 -245.010, which require HHSC to adopt rules necessary to implement Chapter 245, including rules to protect the health and safety of a patient of an abortion facility, and provisions requiring compliance with Chapter 171, Subchapter B.

The amendment is necessary to implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapters 171 and 245.

§139.32.License Denial, Suspension, Probation, or Revocation.

(a) The Texas Health and Human Services Commission (HHSC) [department] may refuse to issue or renew a license for a facility if the facility fails to comply with any provisions of the Act, this chapter, or Health and Safety Code[,] Chapter 171.

(b) Notwithstanding any other part of this chapter, HHSC is prohibited under Health and Safety Code §171.005 and §171.207 from enforcing Health and Safety Code Chapter 171, Subchapter H (relating to Detection of Fetal Heartbeat).

(c) [(b)] HHSC [The department] may suspend, place on probation, or revoke the license of a facility for one or more of the following reasons:

(1) the facility commits fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to HHSC [the department] or required to be maintained by the facility pursuant to the Act;

(2) the facility or any of its employees materially alters any license issued by HHSC [the department];

(3) the facility or its employees commits an act which causes immediate jeopardy to the health and safety of a patient;

(4) the facility is cited for deficiencies and fails to submit an acceptable plan of correction in accordance with this chapter;

(5) the facility has been cited for deficiencies and fails to timely comply with minimum standards for licensure within the dates designated in the plan of correction;

(6) the facility or any of its employees has aided, abetted, or permitted the commission of an illegal act;

(7) the facility or any of its employees fails to comply with any provisions of the Act or this chapter;

(8) the facility is not in compliance with minimum standards for licensure;

(9) the facility fails to provide the required application or renewal information;

(10) the facility fails to comply with an order of the commissioner or another enforcement procedure under the Act;

(11) the facility discloses an action described in §139.23(c)(2)(C)(xi) and (xii) of this chapter [title] (relating to Application Procedures and Issuance of Licenses);

(12) the facility knowingly employs as the facility administrator or chief financial officer an individual who was convicted of a felony or misdemeanor listed in subsection (d) [(c)] of this section; or

(13) the facility has a history of failure to comply with the rules adopted under this chapter.[; or]

[(14) the facility has aided, abetted or permitted the commission of an illegal act.]

(d) [(c)] HHSC [The department] may deny a person a license or suspend or revoke an existing license on the grounds that the person has been convicted of a felony or misdemeanor that directly relates to the duties and responsibilities of the ownership or operation of a facility.

(1) In determining whether a criminal conviction directly relates to the duties and responsibilities of the ownership or operation of a licensed abortion facility, and in determining the fitness of a person who has been convicted of a crime to perform such duties and responsibilities, HHSC [the department] shall consider the provisions of Occupations Code[,] Chapter 53.

(2) HHSC [The department] is entitled to obtain criminal history information maintained by the Texas Department of Public Safety (Government Code[,] §411.122), the Federal Bureau of Investigation (Government Code[,] §411.087), or any other law enforcement agency to investigate the eligibility of an applicant for an initial or renewal license and to investigate the continued eligibility of a licensee.

(3) The following felonies and misdemeanors directly relate to the duties and responsibilities of the ownership or operation of a licensed abortion facility because these criminal offenses demonstrate impaired ability to own or operate a facility:

(A) a misdemeanor violation of Health and Safety Code[,] Chapter 171 or Chapter 245;

(B) a misdemeanor or felony involving moral turpitude;

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

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

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

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

(G) a misdemeanor or felony under the Penal Code:

(i) Title 4--offenses of attempting or conspiring to commit any of the offenses in this clause;

(ii) Title 5--offenses against the person;

(iii) Title 7--offenses against property;

(iv) Title 8--offenses against public administration;

(v) Title 9--offenses against public order and decency;

(vi) Title 10--offenses against public health, safety or morals; or

(vii) Title 11--offenses involving organized crime.

(4) Offenses listed in paragraph (3) of this subsection are not exclusive in that HHSC [the department] may consider similar criminal convictions from other state, federal, foreign or military jurisdictions which indicate an impaired ability or tendency for the person to be unable to own or operate a facility.

(5) A license holder's license shall be revoked on the license holder's imprisonment following a felony conviction, felony community supervision revocation, revocation of parole, or revocation of mandatory supervision.

(e) [(d)] All proceedings for the denial, suspension, probation, or revocation of a license under this section shall be conducted at the State Office of Administrative Hearings, and in accordance with Health and Safety Code[,] Chapter 245; Government Code[,] Chapter 2001; and Chapter 1, Subchapter B [the Formal Hearing Procedures of the Department of State Health Services, §§1.21, 1.23, 1.25, and 1.27] of this title (relating to Formal Hearing Procedures).

(f) [(e)] A person who has had a facility license revoked under this section may not apply for a license under this chapter for one year following the date of revocation.

(g) [(f)] After an on-site inspection in which deficiencies were cited by the surveyor, a facility may surrender its license before expiration or allow its license to expire in lieu of HHSC [the department] proceeding with enforcement action. HHSC [The department] may accept such submission, or reject it and proceed with an enforcement action. The facility, its owner(s), and its affiliates may not reapply for a license for six months from the date of the surrender or expiration.

(h) [(g)] If HHSC [the department] suspends a license, the suspension shall remain in effect until HHSC [the department] determines that the reason for suspension no longer exists. An HHSC [A department] surveyor shall conduct an inspection of the facility prior to making a determination.

(1) During the time of suspension, the suspended license holder shall return the original license certificate to HHSC [the department].

(2) If a suspension overlaps a renewal date, the suspended license holder shall comply with the renewal procedures in this chapter; however, HHSC [the department] may not renew the license until HHSC [the department] determines that the reason for suspension no longer exists.

(3) If suspension is for more than one year, the suspended license holder may apply to HHSC [the department] for cancellation of the suspension only after one year following the initial date of the suspension.

(i) [(h)] If HHSC [the department] revokes or does not renew a license, a person may reapply for a license (subject to subsection (e) [(d)] of this section), by complying with the requirements and procedures in this chapter at the time of reapplication. HHSC [The department] may refuse to issue a license, if the reason for revocation or non-renewal continues to exist, and may consider the enforcement history of the applicant, administrator, or clinical director in making such a determination.

(j) [(i)] Upon revocation or non-renewal, a license holder shall return the original license certificate to HHSC [the department].

(k) [(j)] Upon a licensee's felony conviction, felony probation revocation, revocation of parole, or revocation of mandatory supervision, the license shall be revoked.

(l) [(k)] If HHSC [the department] finds that a licensed abortion facility is in repeated noncompliance with Health and Safety Code[,] Chapter 171 or Chapter 245, or rules adopted under this chapter, but the noncompliance does not in any way involve the health and safety of the public or an individual, HHSC [the department] may schedule the facility for probation rather than suspending or revoking the facility's license.

(m) [(l)] HHSC [The department] may suspend or revoke the license of a licensed abortion facility that does not correct items that were in noncompliance or that does not comply with Health and Safety Code[,] Chapter 171 or Chapter 245, or rules adopted under this chapter within the applicable probation period.

(n) [(m)] HHSC [The department] may suspend or revoke a license to be effective immediately when a situation(s) is identified that poses immediate jeopardy to the health and safety of person(s) at the facility.

(1) HHSC [The department] shall immediately give the licensee adequate notice of the action taken, the legal grounds for the action, and the procedure governing appeal of the action.

(2) HHSC [The department] shall set a hearing date not later than the 14th day after the effective date of the suspension or revocation.

(3) HHSC [The department] shall also notify the facility in writing of the emergency action, the legal grounds for the action, the effective date of the emergency action, the procedure governing appeal of the action, and the date set for the hearing. This notice shall be sent by certified mail, return receipt requested, or by personal delivery. The hearing shall be conducted at the State Office of Administrative Hearings, and pursuant to [the ] Health and Safety Code[,] Chapter 245; Government Code[,] Chapter 2001; and the [department's] formal hearing procedures set out in Chapter 1, Subchapter B [§§1.21, 1.23, 1.25, and 1.27] of this title.

(o) [(n)] If a person violates the licensing requirements of the Act or rules adopted under the Act, HHSC [the department] may petition the district court for a temporary restraining order to restrain the person from continuing the violation or operating without a license.

(p) [(o)] If a person operates a facility without a license as required by this chapter and the Act, the person is liable for a civil penalty of not less than $1,000 nor more than $2,500 for each day of violation.

(q) [(p)] If a facility has had enforcement action taken by HHSC [the department] against it, the facility, its owner(s), or its affiliate(s) may not apply for a facility license for one year following the effective date of the enforcement action. For purposes of this subsection only, the term "enforcement action" means license revocation, suspension, emergency suspension, or denial or injunctive action, but does not include administrative penalties or civil penalties. If HHSC [the department] prevails in one enforcement action (e.g., injunctive action) against the facility but also proceeds with another enforcement action (e.g., revocation) based on some or all of the same violations, but HHSC [the department] does not prevail in the second enforcement action (e.g., the facility prevails), the prohibition in this paragraph does not apply.

(r) [(q)] If HHSC [the department] revokes or does not renew a license and the one-year period described in subsection (q) [(p)] of this section has passed, a person may reapply for a license by complying with the requirements and procedures in this chapter at the time of reapplication. HHSC [The department] may refuse to issue a license, if the reason for revocation or non-renewal continues to exist.

(s) [(r)] Upon revocation or non-renewal, a license holder shall return the license to HHSC [the department].

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 April 22, 2022.

TRD-202201564

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: June 5, 2022

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


SUBCHAPTER D. MINIMUM STANDARDS FOR LICENSED ABORTION FACILITIES

25 TAC §§139.50, 139.52, 139.53, 139.55

STATUTORY AUTHORITY

The amendments 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 Texas Health and Safety Code §171.006, which authorizes HHSC to adopt rules regarding abortion complication reporting, and §§245.009 -245.010, which require HHSC to adopt rules necessary to implement Chapter 245, including rules to protect the health and safety of a patient of an abortion facility, and provisions requiring compliance with Chapter 171, Subchapter B.

The amendments are necessary to implement Texas Government Code §531.0055 and Texas Health and Safety Code Chapters 171 and 245.

§139.50.Disclosure Requirements.

(a) At the time a woman on whom the abortion is to be performed or induced initially consults with a licensed abortion facility, the facility shall comply with the following.

(1) Provide the woman with a written statement indicating the number of the toll-free telephone line which is maintained by the Texas Health and Human Services Commission (HHSC) [department ] to provide specific information relating to licensed abortion facilities in Texas. The statement shall be in accordance with §139.6 of this chapter [title] (relating to Public Information; Toll-Free Telephone Number).

(2) Provide the woman with a written statement identifying HHSC [the department] as the responsible agency for facility complaint investigations. The statement shall indicate that a person may direct a complaint to HHSC Complaint and Incident Intake (CII) and include current CII contact information, as specified by HHSC. [inform persons to register complaints with the Manager, Health Facility Compliance Group, Department of State Health Services, Post Office Box 149347, Austin, Texas 78714-9347. Complaints shall be registered with the department in writing. A complainant shall provide his/her name.] All complaints are [shall be] confidential.

(3) Provide the woman with a copy of HHSC's [the department's] "A Woman's Right to Know" booklet created for women seeking an abortion, if the woman chooses to view it.

(4) Provide the woman with a copy of HHSC's [the department's] "A Woman's Right to Know" resource directory (required by Health and Safety Code[,] §171.015), if the woman chooses to view it.

(5) Inform the woman of her option to view HHSC's [the department's] "A Woman's Right to Know" booklet and resource directory on HHSC's Internet website [the World Wide Web] and provide her with the Internet address for obtaining the information.

(6) Provide the woman with a written statement that she may call HHSC [the department] at (888) 973-0022, if the facility does not provide her with the information required in paragraphs (3) and (4) of this subsection.

(b) The facility shall ensure that the woman on whom the abortion is to be performed or induced receives [has been provided with] all information required for voluntary and informed consent, in accordance with [as mandated by] Health and Safety Code §171.012 [, §171.012(a)(1) and (2)] at least 24 hours prior to the abortion procedure.

(c) The facility shall initiate a clinical record for the woman on whom the abortion is to be performed or induced at the time of the initial consultation. The following information pertaining to disclosure, as described in this section, shall be documented in the clinical record:

(1) the date and time of the initial consultation;

(2) the method by the which the information required under subsections (a) and (b) of this section was provided; and

(3) the name and title of individual(s) who provided or verified the information required under subsections (a) and (b) of this section.

§139.52.Patient Education/Information Services.

(a) A licensed abortion facility shall ensure patient education/information services are provided to each woman on whom the abortion is to be performed or induced to:

(1) ensure compliance with Health and Safety Code[,] §171.011 (relating to Informed Consent Required), and §171.012 (relating to Voluntary Informed Consent) concerning informed consent by utilizing the sonogram and election form as set out in Health and Safety Code §171.012 [the department's certification form], signed by the woman prior to an abortion procedure, and maintained in the patient's clinical record;

[Figure: 25 TAC §139.52(a)(1)]

(2) prepare the patient for surgery in a manner that facilitates her safety and comfort;

(3) assist the patient in reaching a decision about the method of post-procedure birth control she will use, if any, and respect her choices; and

(4) ensure, when medically appropriate, the patient is advised of the physician's obligation to take all reasonable steps to maintain the life and health of a child who is born alive.

(b) A licensed abortion facility shall, if needed, refer a patient to a licensed mental health practitioner who provides therapeutic intervention.

§139.53.Medical and Clinical Services.

(a) Surgical abortion.

(1) The medical consultant shall be responsible for implementing and supervising the medical and clinical policies of the facility.

(2) All medical and clinical services of the facility, with the exception of the abortion procedure, shall be provided under the direction of a physician or registered nurse who assumes responsibility for the clinical employees' performance in the facility.

(3) A licensed abortion facility shall ensure that a surgical consent form is signed by the patient prior to the procedure being started, that the patient is informed of the risks and the benefits of the procedure, and that the patient recognizes the alternatives to abortion. Informed consent shall be in accordance with rules adopted by the Texas Medical Disclosure Panel under §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A), §601.4 of this title (relating to Disclosure and Consent Form), and Health and Safety Code[,] §171.011 (relating to Informed Consent Required), and §171.012 (relating to Voluntary Informed Consent).

(4) A licensed abortion facility shall ensure that the attending physician, advanced practice registered nurse, or physician assistant has obtained and documented a preoperative history, physical exam, and laboratory studies, including verification of pregnancy.

(5) A licensed abortion facility shall ensure that:

(A) the attending physician examines each patient immediately prior to surgery to evaluate the risk to the procedure; and

(B) the person administering the anesthetic agent(s) examines the patient immediately prior to surgery to evaluate the risk of anesthesia.

(6) The administration of anesthesia shall be in accordance with §139.59 of this subchapter [title] (relating to Anesthesia Services).

(7) An abortion shall be performed only by a physician.

(8) A physician, advanced practice registered nurse, physician assistant, registered nurse, or licensed vocational nurse shall be in the facility whenever there is a patient in the procedure room or recovery room. While a patient is in the procedure room or recovery room she shall not be left unattended.

(9) The recovery room(s) at the facility shall be supervised by a physician, advanced practice registered nurse, physician assistant, or registered nurse. This supervisor shall be available for recovery room staff within a recommended 10 minutes with a maximum required 15 minutes while any patient is in the recovery room.

(10) A physician shall be available for the facility while any patient is in the recovery room within a recommended 10 minutes and a maximum required 15 minutes.

(11) The facility shall ensure that a patient is fully reactive and her vital signs are stable before discharging the patient from the facility upon written order by the attending physician.

(12) All fetal tissue shall be examined grossly at the time of the procedure. In the absence of visible fetal parts or placenta, the tissue may be examined by magnification for the detection of villi. If this examination is inconclusive, the tissue shall be sent to a pathology lab. The results of the tissue examination shall be recorded in the patient's clinical record.

(13) A facility shall meet the requirements set forth by the department in §§1.131 - 1.137 of this title (relating to Definition, Treatment, and Disposition of Special Waste from Health Care-Related Facilities).

(b) Medical abortion.

(1) The medical consultant shall be responsible for implementing and supervising the medical and clinical policies of the facility.

(2) All medical and clinical services of the facility, with the exception of the abortion procedure, shall be provided under the direction of a physician or registered nurse who assumes responsibility for the clinical employees' performance in the facility.

(3) A licensed abortion facility shall ensure:

(A) the physician(s) providing medical abortion is able to accurately date a pregnancy;

(B) the physician(s) is able to determine that the pregnancy is not an ectopic gestation;

(C) the physician(s) is able to provide surgical intervention or provide for the patient to receive a surgical abortion if necessary; and

(D) patients have access to medical facilities equipped to provide blood transfusion and patient resuscitation, if necessary.

(4) A licensed abortion facility shall ensure follow-up examination and services are provided to patients requesting medical abortion.

(5) A licensed abortion facility shall ensure that the attending physician, advanced practice registered nurse, or physician assistant has obtained and documented a pre-procedure history, physical exam, and laboratory studies, including verification of pregnancy.

(6) A licensed abortion facility shall ensure:

(A) written consent is obtained from the patient prior to the commencement of the abortion procedure in accordance with §139.50 of this chapter (relating to Disclosure Requirements);

(B) the patient is informed of the risks and benefits of the procedure;

(C) the patient is informed of the possibility that a surgical abortion may be required;

(D) the patient is informed of the alternatives to abortion; and

(E) informed consent is in accordance with rules adopted by the Texas Medical Disclosure Panel under §601.2 of this title, §601.4 of this title, and Health and Safety Code[,] §171.011 and §171.012.

(7) A licensed abortion facility shall provide the patient with written discharge instructions including a direct referral to a physician who shall accept the patient for surgical abortion.

(c) Requirements of a physician. A physician performing or inducing an abortion must, on the date the abortion is performed or induced, have active admitting privileges at a hospital that:

(1) is located not further than 30 miles from the location at which the abortion is performed or induced; and

(2) provides obstetrical or gynecological health care services.

§139.55.Clinical Records.

(a) A licensed abortion facility shall maintain a daily patient roster of all patients receiving abortion services. This daily patient roster shall be retained for a period of five years.

(b) A licensed abortion facility shall establish and maintain a clinical record for each patient. A licensed abortion facility shall maintain the record to assure that the care and services provided to each patient is completely and accurately documented, and readily and systematically organized to facilitate the compilation and retrieval of information. [Information required for the annual abortion report shall be readily retrievable from the clinical record.]

(1) The facility shall have written procedures which are adopted, implemented, and enforced regarding the removal of records and the release of information. A facility shall not release any portion of a patient record to anyone other than the patient except as allowed by law.

(2) All information regarding the care and services shall be centralized in the record and be protected against loss or damage and unofficial use.

(3) The facility shall establish an area for patient record storage. The patient records shall be retrievable within two hours by the facility for patients whose date of the last visit is less than twelve months. For patients whose date of the last visit is greater than twelve months, records shall be retrievable within ten days.

(4) The facility shall ensure that each record is treated with confidentiality.

(5) The clinical record shall be an original, a microfilmed copy, an optical disc imaging system or other electronic means, or a certified copy. An original record includes manually signed paper records or electronically signed computer records. Computerized records shall meet all requirements of paper records including protection from unofficial use and retention for the period specified in subsection (d) of this section. Systems shall assure that entries regarding the delivery of care or services are not altered without evidence and explanation of such alteration.

(6) A facility shall maintain clinical records in their original state. Each entry shall be accurate, dated with the date of entry, and signed by the individual making the entry. Correction fluid or tape shall not be used in the record. Corrections shall be made by striking through the error with a single line, and shall include the date the correction was made and the initials of the person making the correction.

(c) The clinical record shall contain:

(1) patient identifying information;

(2) name of physician;

(3) diagnosis;

(4) history and physical;

(5) a preanesthesia evaluation performed by personnel approved by the facility to provide anesthesia services;

(6) laboratory reports;

(7) report of gross and/or microscopic examination of tissue obtained during a surgical abortion;

(8) allergies/drug reactions;

(9) physician's orders;

(10) progress notes to include at a minimum notations of vital signs; signs and symptoms; response to medication(s) and treatment(s); and any changes in physical or emotional condition(s). These notations shall be written, dated, and signed by the individual(s) delivering patient care no later than 10 days from the day the patient is discharged from the facility;

(11) education/information and referral notes;

(12) signed patient consent form;

(13) medication administration records. Notations of all pharmaceutical agents shall include the time and date administered, the name of the individual administering the agent, and the signature of the person making the notation if different than the individual administering the agent;

(14) condition on discharge;

(15) the medical examination or written referral, if obtained;

(16) physician documentation of viability or nonviability of fetus(es) at a gestational age greater than 26 weeks; [and]

(17) for patients receiving moderate sedation/analgesia or deep sedation/analgesia:

(A) a minimum of blood pressure, pulse, and respirations shall be obtained and recorded before sedation, during sedation, during the procedure, during the initial recovery period, and before discharge from the facility; and

(B) the patient's blood oxygenation shall be assessed and recorded, a minimum of at the time of sedation, during the procedure, and after the procedure;[.]

(18) for an abortion performed or induced because of a medical emergency, a written document executed by the physician certifying the abortion is necessary due to a medical emergency and specifying the medical condition requiring the abortion;

(19) for an abortion performed or induced to preserve the health of the patient, a written document executed by the physician specifying the medical condition the abortion is asserted to address and providing the medical rationale for the physician's conclusion that the abortion is necessary to address the medical condition; and

(20) for an abortion performed or induced for a reason other than an abortion described by paragraph (19) of this subsection, a written document executed by the physician specifying that maternal health is not a purpose of the abortion.

(d) A licensed abortion facility shall retain clinical records for adults for seven years from the time of discharge and clinical records for minors for five years past the age the patient reaches majority.

(e) A licensed abortion facility may not destroy patient records that relate to any matter that is involved in litigation if the facility knows the litigation has not been finally resolved.

(f) If a licensed abortion facility closes, there shall be an arrangement for the preservation of inactive records to ensure compliance with this section. The facility shall send the Texas Health and Human Services Commission [department] written notification of the reason for closure, the location of the patient records, and the name and address of the patient record custodian. If a facility closes with an active patient roster, a copy of the active patient record shall be transferred with the patient to the receiving facility or other health care facility in order to assure continuity of care and services to the patient.

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 April 22, 2022.

TRD-202201565

Karen Ray

Chief Counsel

Department of State Health Services

Earliest possible date of adoption: June 5, 2022

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