Adopted Rules Title 25

TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 139. ABORTION FACILITY REPORTING AND LICENSING

The Executive Commissioner of the Health and Human Services Commission (commission) on behalf of the Department of State Health Services (department) adopts the repeal of §§139.1 - 139.8, 139.21 - 139.25, 139.31 - 139.33, and 139.41 - 139.60 and new §§139.1 - 139.8, 139.21 - 139.25, 139.31 - 139.33, and 139.41 - 139.60, concerning the regulation of abortion facilities. New §§139.2, 139.6, 139.8, 139.23, 139.46 - 139.49, 139.51, 139.53, 139.54, 139.57, and 139.59 are adopted with changes to the proposed text as published in the December 19, 2008, issue of the Texas Register (33 TexReg 10269). The repeal of §§139.1 - 139.8, 139.21 - 139.25, 139.31 - 139.33, and 139.41 - 139.60 and new §§139.1, 139.3 - 139.5, 139.7, 139.21, 139.22, 139.24, 139.25, 139.31 - 139.33, 139.41 - 139.45, 139.50, 139.52, 139.55, 139.56, 139.58 and 139.60 are adopted without changes and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The repeals and new sections are necessary to update and clarify the rules. Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 139.1 - 139.8, 139.21 - 139.25, 139.31 - 139.33, and 139.41 - 139.60 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

SECTION-BY-SECTION SUMMARY

New §§139.1 - 139.8, 139.21 - 139.25, 139.31 - 139.33, and 139.41 - 139.60 provide clarification to the rules and update references to statutes and rules, the names and contact information of boards, the department and its programs. The new §139.2 deletes definitions not used in the rules, adds the definitions of advanced practice nurse, fetus, medical abortion, physician assistant, and surgical abortion, and revises the definitions of certified registered nurse anesthetist, director, licensed vocational nurse, physician, and registered nurse. The new §§139.21 - 139.23 delete references to certain dates. The new §139.49 clarifies the use of steam sterilizers. The new §139.50 and §139.52 clarify that disclosure, patient education and information services are to be provided to a woman on whom the abortion is to be performed. The new §139.54 deletes language concerning the scope of practice for licensed vocational nurses and changes nursing services to licensed health care professionals. The new §139.55 requires a preanesthesia evaluation by personnel approved to provide anesthesia services. The new §139.59 revises anesthesia services using language similar to the ambulatory surgical center rules for consistency.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenters were individuals, associations, and/or groups, including the following: Texas Association of Nurse Anesthetists, Texas Society of Anesthesiologists, Whole Woman's Health, LLC, Society of Diagnostic Medical Sonography, Texas Association of Planned Parenthood Affiliates, and Texas Alliance for Life. The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments.

Comment: Concerning Chapter 139, one commenter suggested a requirement for mandatory credentialing of sonographers to include minimum education standards for credentialing, and sonography laboratory accreditation.

Response: The commission disagrees. Section 139.46(4) provides that the requirements and qualifications for training and experience of ancillary staff are prescribed by the facility administrator and the medical consultant as needed. Section 139.41(a) provides that the licensee is responsible for "developing, implementing, enforcing, and monitoring written policies governing the facility's total operation, and for ensuring that these policies comply with the Act and the applicable provisions of this chapter and are administered so as to provide health care in a safe and professionally acceptable environment." Section 139.41(a)(2) specifically references "clinical policies governing medical and clinical practices and procedures of the facility." No change has been made to the rule as a result of this comment.

Comment: Concerning Chapter 139, one commenter suggested adding a requirement that any abortion performed on a minor require the written, notarized consent of a parent as required by the Board of Medical Examiners.

Response: The commission disagrees. Parental consent for an abortion performed on a minor is not required under certain circumstances as set out in Family Code, Chapter 33. The suggested requirement would be in conflict with existing law. No change has been made to the rule as a result of this comment.

Comment: Concerning §139.1(b), one commenter requests that entities that advertise they perform abortions should be required to obtain a license as an abortion facility.

Response: The commission disagrees. The Health and Safety Code, §245.004, sets out exemptions from licensing which include (1) a hospital licensed under Chapter 241 (Texas Hospital Licensing Law); (2) the office of a physician licensed under Subtitle B, Title 3, Occupations Code, unless the office is used for the purpose of performing more than 50 abortions in any 12-month period; or (3) an ambulatory surgical center licensed under Chapter 243. No change has been made to the rule as a result of this comment.

Comment: Concerning §139.2(5) and (10), 139.6(e), 139.8(b)(2), 139.23(c)(2)(C)(x), 139.46(3)(A), 139.53(a)(4), (8), (9), (b)(5), 139.54(a)(2), and 139.57(a)(2)(C), one commenter requested that the term "advanced practice nurse" be changed to "advanced practice registered nurse" throughout the proposed rules to agree with amendments to the Texas Board of Nursing rules adopted on November 14, 2008.

Response: The commission agrees with the commenter and has replaced the term "advanced practice nurse" with "advanced practice registered nurse."

Comment: Concerning §139.2(10), one commenter requested that the words "currently licensed" and "authorized" be deleted to remove redundancy from the definition.

Response: The commission agrees with the commenter and has deleted "currently licensed," but disagrees that "authorized" be deleted because the term "authorized" is in agreement with 22 Texas Administrative Code, Part 11, Chapter 221, §221.2.

Comment: Concerning §139.2(30) and (52), one commenter states that there should be only one definition of abortion and cites the statute Health and Safety Code, Chapter 245, which has only a single definition of abortion and does not distinguish between surgical and medical methods of abortion.

Response: The commission disagrees. The general definition of abortion is provided in §139.2(1), which does not distinguish between surgical and medical methods of abortion. The two distinct types of abortions available require differentiation and specific regulatory requirements to protect the health and safety of patients, hence the addition of the definitions in §139.2(30) and (52). No change has been made to the rule as a result of this comment.

Comment: Concerning §139.48(1)(C) and (2), and §139.49, one commenter proposes that facilities that perform only medication abortion be exempted from these requirements.

Response: Concerning §139.48(1)(C), the commission agrees that facilities that do not administer moderate sedation/analgesia, deep sedation/analgesia or general anesthesia do not require a separate recovery room and has added "if moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia are administered at the facility." Concerning §139.48(2), the commission agrees and has added "in facilities that provide vacuum aspiration." Equipment for vacuum aspiration should be electrically safe and designed to prevent reverse pump action. The standard applies to any facility that performs vacuum aspiration. Concerning §139.49, the commission disagrees that an abortion facility would be exempted from the entire section regarding infection control standards. Concerning §139.49(d)(2), the commission agrees that facilities performing only medical abortions should not be required to ensure that surgical instruments are available for performing conventional cervical dilatation and curettage and has added "if this procedure is available at the facility."

Comment: Concerning §139.53(a)(5)(A) and (B), and §139.55(c)(5), one commenter stated that the effect of the current proposal would be to authorize registered nurses to perform preanesthesia evaluations of patients for anesthesia risk factors. The evaluation of a patient for risks associated with anesthesia should be performed by a physician, and the proposed language compromises patient safety.

Response: The commission disagrees with the commenter. These rules address the responsibilities of the person administering anesthesia and do not compromise patient safety. In addition to the pre-anesthesia evaluation, the rule at §139.59(e) requires the physician to evaluate the patient immediately prior to the procedure to assess the risk of the anesthesia and of the procedure to be performed. No change has been made to the rule as a result of this comment.

Comment: Concerning §139.53(a)(10), one commenter suggested that "available" be defined as able to be physically present in the facility to assume responsibility for the delivery of patient care services within five minutes.

Response: The commission disagrees with the commenter. This would be a substantive change to the proposed rules. The scope of service delivery in an abortion facility is extremely limited in comparison with an ambulatory surgical center or hospital and incorporating such a requirement would necessitate extensive research and stakeholder input. No change has been made to the rule as a result of this comment.

Comment: Concerning §139.59, one commenter proposes that no changes should be made to the abortion facilities anesthesia services requirements as it would impose onerous ambulatory surgical center anesthesia requirements on abortion facilities.

Response: The commission agrees that with the advent of medical abortions, some changes to §139.59 are warranted and have been made. Sections 139.59(a), (b), (d), (d)(4), (e), (f) and (j)(2)(E) were revised with regard to facilities which do not administer moderate sedation/analgesia, deep sedation/analgesia or general anesthesia and are specifically addressed in the following comments.

Comment: Concerning §139.59(a), one commenter suggested that topical, local and minimal anesthesia be excluded from the regulations of anesthesia services for purposes of staffing or patient monitoring.

Response: The commission disagrees. Section 139.59(c) states that the facility medical staff develops written policies and practice guidelines for the anesthesia service in accordance with standards, guidelines, and applicable licensing rules. No change has been made to the rule as a result of this comment.

Comment: Concerning §139.59(b), one commenter states there is no need for an "anesthesia department" in abortion facilities utilizing minimal or moderation sedation.

Response: The commission agrees and has deleted "the" and added "an" in reference to "anesthesia department," and has added the phrase "required if moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia are administered at the facility and shall be." The commission has added the word "when" to §139.59(a) to read "Anesthesia services when provided in the abortion facility shall be limited to those that are approved by the governing body, which may include the following."

Comment: Concerning §139.59(d), one commenter suggested adding the words "or CRNA" as a CRNA may need to direct a registered nurse to administer a sedative drug during surgery.

Response: The commission agrees and has added the words "or CRNA."

Comment: Concerning §139.59(d)(4), one commenter states that the requirement for the registered nurse to have no other duties except to monitor the patient is unnecessary and unreasonable as applied to certain types of minimal sedation used in abortion procedures, such as a one-time dose of ibuprofen (or similar analgesic medication) and diazepam (or similar oral sedative) which do not require the level of training of a registered nurse. The commenter suggests that certain types of minimal sedation commonly used in abortion procedures can be administered by a qualified individual for the unsupervised treatment of anxiety or pain.

Response: The commission agrees and has added the term "moderate" to indicate that a registered nurse who is not a CRNA shall "ensure that, when administering moderate sedation during a procedure, the registered nurse has no other duties except to monitor the patient." Per §139.59(d)(1) - (3), the facility is required to verify that the registered nurse administering sedation has the requisite training, education, and experience; to maintain documentation to support that the registered nurse has demonstrated competency in the administration of sedation; and to develop, implement and enforce detailed, written policies and procedures to guide the registered nurse. Per the Nurse Practice Act of 22 Texas Administrative Code, Part 11, §217.11, the registered nurse must comply with and is responsible to (B) Implement measures to promote a safe environment for clients and others; (C) Know the rationale for and the effects of medications and treatments and shall correctly administer the same; and (M) Institute appropriate nursing interventions that might be required to stabilize a client's condition and/or prevent complications.

Comment: Concerning §139.59(e), one commenter requested that the rule be changed to require the physician, an anesthesiologist, or the certified registered nurse anesthetist (CRNA) who will be administering the anesthesia to evaluate the patient immediately prior to the procedure to assess the risk of anesthesia relative to the procedure to be performed. One of the commenters requested the term "physician" be changed to "operating surgeon."

Response: The commission disagrees with the commenter as the rule requires the physician to evaluate the patient immediately prior to the procedure to assess the risk of the anesthesia and to assess the risk of the procedure to be performed. The commission agrees with the commenter to change "physician" to "operating surgeon."

Comment: Concerning §139.59(f), two commenters requested that "CRNA" be added to the list of personnel required to be available until all of his or her patients operated on that day have been discharged to the recovery room.

Response: The commission agrees with the commenter and has added "CRNA."

Comment: Concerning §139.59(j)(2)(D), one commenter suggested that the requirement for electrocardiographic monitoring equipment in abortion facilities using moderate sedation is unnecessary.

Response: The commission disagrees. Section 139.59(j)(2)(D) states that facilities that provide sedation, to include moderate sedation/analgesia, deep sedation/analgesia, regional analgesia and/or general anesthesia require electrocardiographic monitoring equipment. No change has been made to the rule as a result of this comment.

Comment: Concerning §139.59(j)(2)(E), one commenter suggested that the requirement for cardiovertor-defibrillator equipment in abortion facilities using moderate sedation is unnecessary.

Response: The commission agrees and has deleted the term "cardiovertor-defibrillator" and has added the term "cardiac defibrillator" to enable facilities to determine the type of defibrillator appropriate for the type of anesthesia services provided at the facility.

Comment: Concerning §139.59(j)(2)(E), one commenter clarified the difference between a cardiovertor-defibrillator (implantable device) and a cardioversion-defibrillator (used in advanced cardiopulmonary resuscitation). The commenter suggested that the requirement for cardiovertor-defibrillator equipment in abortion facilities using moderate sedation is unreasonable. The commenter proposed either (a) only an AED (automated external defibrillator) or (b) a cardioversion-defibrillator or an AED at facilities that provide only moderate sedation.

Response: The commission agrees and has deleted "cardiovertor-defibrillator" and has added "cardiac defibrillator" to enable facilities to determine the type of defibrillator related to specific anesthesia services provided at the facility.

The following changes have been made to correct errors and provide consistency of terms.

Change: Concerning §139.2(38), the agency name "Texas State Board of Physician Assistant Examiners" was corrected to "Texas Physician Assistant Board."

Change: Concerning §139.47(b)(2), the words "color, sex, or disability" were added for consistency concerning the employment of personnel.

Change: Concerning §139.51(6), the word "creed" was deleted and the words "color, age, sex, religion or disability" were added for consistency concerning women's access to care and treatment.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

SUBCHAPTER A. GENERAL PROVISIONS

25 TAC §§139.1 - 139.8

STATUTORY AUTHORITY

The repeals are authorized by Health and Safety Code, §245.009, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the issuance, renewal, denial, suspension, and revocation of each license; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902279

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

25 TAC §§139.1 - 139.8

STATUTORY AUTHORITY

The new rules are authorized by Health and Safety Code, §245.009, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the issuance, renewal, denial, suspension, and revocation of each license; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

§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 use of any means to terminate the pregnancy of a female known by the attending physician to be pregnant, with the intention that the termination of the pregnancy by those means will, with reasonable likelihood, cause the death of the fetus. 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.

(2) Abortion facility--A place where abortions are performed.

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

(4) 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 title (relating to Licensed Abortion Facility Staffing Requirements and Qualifications).

(5) 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."

(6) 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.

(7) 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;

(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.

(8) Ambulatory surgical center--An ambulatory surgical center licensed under Health and Safety Code, Chapter 243.

(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.

(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.

(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.

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

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

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

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

(16) Director--The director of the Patient Quality Care Unit of the department or his or her designee.

(17) 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.

(18) 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.

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

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

(21) 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.

(22) 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.

(23) 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.).

(24) 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.

(25) Inspection--An on-site inspection by the department in which a standard-by-standard evaluation is conducted.

(26) Licensed abortion facility--A place licensed by the department under Health and Safety Code, Chapter 245, where abortions are performed.

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

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

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

(30) Medical abortion--The 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.

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

(32) 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.

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

(34) 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.

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

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

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

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

(39) 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 system(s) operation(s) of the facility as the system(s) operation(s) apply to the deficiency.

(40) 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.

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

(42) Pre-inspection conference--A conference held with department 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.

(43) 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 they are licensed or certified.

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

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

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

(47) 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.

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

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

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

(51) 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.

(52) 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.

(53) Third trimester certification form--The document prepared by the Department of State Health Services 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.

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

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

§139.6.Public Information; Toll-Free Telephone Number.

(a) An abortion facility shall provide to a woman, at the time the woman initially consults the facility, a written statement indicating the number of the toll-free telephone number maintained under subsection (d) of this section. The written statement shall be available in English and Spanish.

(1) The following form is an example of the statement in English.

Figure: 25 TAC §139.6(a)(1)

(2) The following form is an example of the statement in Spanish.

Figure: 25 TAC §139.6(a)(2)

(b) The department on request shall make the following information available to the public:

(1) the status of the license of any abortion facility;

(2) the date of the last inspection of the facility, any violation discovered during that inspection that would pose a health risk to a patient at the facility, any challenge raised by the facility to the allegation that there was a violation, and any corrective action that is acceptable to the department and that is being undertaken by the facility with respect to the violation; and

(3) an administrative or civil penalty imposed against the facility or a physician who provides services at the facility, professional discipline imposed against a physician who provides services at the facility, and any criminal conviction of the facility or a physician who provides services at the facility that is relevant to services provided at the facility.

(c) Subsection (b) of this section does not require the department to provide information that is not in the possession of the department. In accordance with Health and Safety Code, §245.023(b), the Texas Medical Board (board) is required to provide to the department information in the possession of the board that the department is required to provide under subsection (b) of this section.

(d) In accordance with Health and Safety Code, §245.023(c), the department shall maintain a toll-free telephone number that a person may call to obtain the information described by subsection (b) of this section.

(e) This section does not authorize the department to the release of the name, address, or phone number of any employee or patient of an abortion facility or of a physician, advanced practice registered nurse, or physician assistant who provides services at an abortion facility.

§139.8.Quality Assurance.

(a) Quality Assurance (QA) Program. A licensed abortion facility shall maintain a QA program in the facility which shall be implemented by a QA committee. The QA program shall be ongoing and have a written plan of implementation. This plan shall be reviewed and updated or revised at least annually by the QA Committee. The QA program shall include measures for quality improvement in the measurement of the facility's delivery of service. Quality assurance documents pertinent to the facility shall be kept within the facility.

(b) QA committee membership. At a minimum, the QA committee shall consist of at least:

(1) the medical consultant designated by the facility;

(2) an advanced practice registered nurse, a physician assistant, a registered nurse, or a licensed vocational nurse; and

(3) at least two other members of the facility's staff.

(c) Frequency of QA committee meetings. The QA committee, by consensus, shall meet at least quarterly to identify issues with respect to which quality assurance activities are necessary.

(d) Minimum responsibilities. The QA committee shall:

(1) evaluate all organized services related to patient care, including services furnished by contract;

(2) ensure that there is a review of any abortion procedure complication(s), and shall make use of the findings in the development and revision of facility policies;

(3) address issues of unprofessional conduct by any member of the facility's staff (including contract staff);

(4) monitor infection control as outlined in §139.49 of this title (relating to Infection Control Standards) and post-procedure infections as outlined in §139.41 of this title (relating to Policy Development and Review);

(5) address medication therapy practices;

(6) address the integrity of surgical instruments, medical equipment, and patient supplies; and

(7) address services performed in the facility as they relate to appropriateness of diagnosis and treatment.

(e) Patient care and service issues. The QA committee shall identify and address patient care services and information issues and implement corrective action plans as necessary.

(1) Identifying issues that necessitate corrective action. The QA committee shall be responsible for identifying issues that necessitate corrective action by the committee, such as issues which negatively affect care or services provided to patients.

(2) Plan of corrective action. The QA committee shall develop and implement plans of action to correct identified deficiencies.

(3) Remedial action. The QA committee shall take and document remedial action to address deficiencies found through the QA program. The facility shall document the outcome of the remedial action.

(f) Departmental review.

(1) The department shall not use good faith efforts by the QA committee to identify and correct deficiencies as a basis for deficiency(ies), citation(s), or sanction(s).

(2) Department surveyors shall verify that:

(A) the facility has a QA committee which addresses concerns; and

(B) the facility staff know how to access that process.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902280

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER B. LICENSING PROCEDURES

25 TAC §§139.21 - 139.25

STATUTORY AUTHORITY

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902281

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

25 TAC §§139.21 - 139.25

STATUTORY AUTHORITY

§139.23.Application Procedures and Issuance of Licenses.

(a) Purpose. This section establishes the application procedures that an abortion facility shall follow to obtain a license to operate as a licensed abortion facility in Texas.

(b) Definitions. The following terms when used in this section shall have the following meaning.

(1) Initial license--A license which is issued by the department to all first-time applicants for an abortion facility license, including those from unlicensed operating facilities and licensed facilities for which a change of ownership is anticipated, that meet the requirements of the Act and this chapter and have successfully completed the application procedures for an initial license as set out in subsection (c) of this section. Initial licenses shall expire in two years.

(2) Renewal license--A license issued by the department to a licensed abortion facility that meets all requirements of the Act and this chapter and has completed the application procedures for obtaining a renewal license as set out in subsection (d) of this section. Renewal licenses shall expire in two years.

(c) Application procedures for an initial license. This subsection establishes the application procedures for obtaining an initial license.

(1) Request for an application. Upon request for an abortion facility license, the department shall furnish a person with an application packet. Applications may also be obtained and submitted through the department's web site.

(2) Application requirements. The applicant shall submit the information listed in subparagraph (C) of this paragraph to the department.

(A) An applicant shall not misstate a material fact on any documents required to be submitted under this subsection.

(B) The application form shall be accurate and complete and shall contain original signatures. The initial license fee shall accompany the application.

(C) The following documents shall be submitted with the original application form prescribed by the department and shall be originals or notarized copies:

(i) information on the applicant including name, street address, mailing address, social security number or franchise tax identification number, date of birth, and driver's license number;

(ii) the name, mailing address, and street address of the abortion facility. The address provided on the application shall be the address from which the abortion facility will be operating and providing services;

(iii) the telephone number of the facility, the telephone number where the administrator can usually be reached when the facility is closed, and if the facility has a fax machine, the fax number;

(iv) a list of names and business addresses of all persons who own any percentage interest in the applicant including:

(I) each limited partner and general partner if the applicant is a partnership; and

(II) each shareholder, member, director, and officer if the applicant is a corporation, limited liability company, or other business entity;

(v) a list of any businesses with which the applicant subcontracts and in which the persons listed under clause (iv) of this subparagraph hold any percentage of the ownership;

(vi) if the applicant has held or holds an abortion facility license or has been or is an affiliate of another licensed facility, the relationship, including the name and current or last address of the other facility, and the date such relationship commenced and, if applicable, the date it was terminated;

(vii) if the facility is operated by or proposed to be operated under a management contract, the names and addresses of any person and organization having an ownership interest of any percentage in the management company;

(viii) a notarized affidavit attesting that the applicant is capable of meeting the requirements of this chapter;

(ix) an organizational structure of the staffing for the abortion facility. The organizational structure shall include full disclosure in writing of the names and addresses of all owners and persons controlling any ownership interest in the abortion facility. In the case of corporations, holding companies, partnerships, and similar organizations, the names and addresses of officers, directors, and stockholders, both beneficial and of record, when holding any percent, shall be disclosed. In the case of a nonprofit corporation, the names and addresses of the officers and directors shall be disclosed;

(x) the name(s), address(es), and Texas physician license number(s) of the physician(s) (including the facility's designated medical consultant), and all advanced practice registered nurse(s) and physician assistant(s) who will provide services at the abortion facility;

(xi) the following data concerning the applicant, the applicant's affiliates, and the managers of the applicant:

(I) denial, suspension, probation, or revocation of an abortion facility license in any state, a license for any health care facility or a license for a home and community support services agency (agency) in any state or any other enforcement action, such as (but not limited to) court civil or criminal action in any state;

(II) denial, suspension, probation, or revocation of or other enforcement action against an abortion facility license in any state, a license for any health care facility in any state, or a license for an agency in any state which is or was proposed by the licensing agency and the status of the proposal;

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

(IV) federal or state (any state) criminal felony arrests or convictions;

(V) Medicare or Medicaid sanctions or penalties relating to the operation of a health care facility or agency;

(VI) operation of a health care facility or agency that has been decertified or terminated from participation in any state under Medicare or Medicaid; or

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

(xii) for the two-year period preceding the application date, the following data concerning the applicant, the applicant's affiliates, and the managers of the applicant:

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

(II) federal or state (any state) tax liens;

(III) unsatisfied final judgments;

(IV) eviction involving any property or space used as an abortion facility or health care facility in any state;

(V) injunctive orders from any court; or

(VI) unresolved final Medicare or Medicaid audit exceptions.

(3) Applicant copy. The applicant shall retain a copy of all documentation that is submitted to the department.

(4) Application processing. Upon the department's receipt of the application form, the required information described in paragraph (2)(C) of this subsection, and the initial license fee from an applicant, the department shall review the material to determine whether it is complete and correct.

(A) The time periods for reviewing the material shall be in accordance with §139.25 of this title (relating to Time Periods for Processing and Issuing a License).

(B) If an abortion facility receives a notice from the department that some or all of the information required under paragraph (2)(C) of this subsection is deficient, the facility shall submit the required information no later than six months from the date of the notice.

(i) A facility which fails to submit the required information within six months from the notice date is considered to have withdrawn its application for an initial license. The license fee shall not be refunded.

(ii) A facility which has withdrawn its application shall reapply for a license in accordance with this subsection, if it wishes to continue the application process. A new license fee is required.

(5) Withdrawal from the application process. If an applicant decides at any time not to continue the application process for an initial license, the application shall be withdrawn upon written request from the applicant.

(6) Issuance of an initial license.

(A) Time periods for processing. The time periods for processing an initial application shall be in accordance with §139.25 of this title.

(B) Effective period of an initial license. The initial license is valid for two years. The initial license expires on the last day of the month ending the licensure period.

(C) Pre-inspection conference. Once the department has determined that the application form, the information required to accompany the application form, and the initial license fee are complete and correct, the department shall schedule a pre-inspection conference with the applicant in order to inform the applicant or his or her designee of the standards for the operation of the abortion facility. The department, at its discretion, may waive the pre-inspection conference. Upon recommendation by the pre-inspection conference, the department shall issue an initial license to the facility.

(D) Pre-inspection recommendation. After the pre-inspection conference has been held, the department shall:

(i) issue an initial license to the owner of a facility, if the facility is found to be in compliance with the department's requirements for initial licensure; or

(ii) deny the application, if the facility has not complied with the department's requirements for issuing an initial license. The procedure for denial of a license shall be in accordance with §139.32 of this title (relating to License Denial, Suspension, Probation, or Revocation).

(7) A department representative shall inspect the abortion facility in accordance with §139.31 of this title (relating to On-Site Inspections and Complaint Investigations of a Licensed Abortion Facility) within 60 days after the issuance of an initial license. If the department determines that a facility is not in compliance with the provisions of the Act or this chapter after the initial on-site inspection, the department shall notify the facility. Notification shall be in accordance with §139.32 of this title.

(8) If for any reason, an applicant decides not to continue the application process, the applicant shall submit to the department a written request to withdraw its application. If an initial license has been issued, the applicant shall cease providing abortion services and return the initial license to the department with its written request to withdraw. The department shall acknowledge receipt of the request to withdraw. The license fee shall not be refunded.

(9) Continuing compliance by the abortion facility with the provisions of the Act and this chapter is required during the initial license period.

(d) Application procedures for renewal of a license.

(1) The department shall send notice of expiration of a license to the licensee at least 60 days before the expiration date of the license. If the licensee has not received notice of expiration from the department 45 days prior to the expiration date, it is the duty of the licensee to notify the department and request an application for a renewal license.

(2) The licensee shall submit the following items to the department by certified mail, marked confidential, and postmarked no later than 30 days prior to the expiration date of the license:

(A) a complete and accurate renewal application form;

(B) current updated documents containing all the information required in subsection (c)(2)(C) of this section; and

(3) A facility shall not misstate a material fact on any documents required to be submitted to the department or required to be maintained by the facility in accordance with the provisions of the Act and this chapter.

(4) A department surveyor shall inspect a licensed abortion facility in accordance with §139.31(b) of this title.

(5) If a licensee makes timely and sufficient application for renewal, the license shall not expire until the department issues the renewal license or until the department denies renewal of the license.

(A) The department shall issue a renewal license to a licensee who meets the minimum standards for a license in accordance with the provisions of the Act and this chapter.

(B) The department may propose to deny the issuance of a renewal license if:

(i) based on the inspection report, the department determines that the abortion facility does not meet or is in violation of any of the provisions of the Act or this chapter;

(ii) renewal is prohibited by the Education Code, §57.491, relating to defaults on guaranteed student loans;

(iii) a facility discloses any of the actions or offenses listed in subsection (c)(2)(C)(xi) and (xii) of this section; and

(iv) a facility fails to file abortion reports in accordance with §139.4 of this title (relating to Annual Reporting Requirements for All Abortions Performed) or fails to ensure that the physicians report is filed in accordance with §139.5 of this title (relating to Additional Reporting Requirements for Physicians).

(6) If a licensee makes a timely application for renewal of a license, and action to revoke, suspend, place on probation, or deny renewal of the license is pending, the license does not expire but does extend until the application for renewal is granted or denied after the opportunity for a formal hearing. A renewal license shall not be issued unless the department has determined the reason for the proposed action no longer exists.

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

(8) If the department revokes or does not renew a license, a person may apply for an initial license by complying with the requirements of the Act and this chapter at the time of reapplication. The department may refuse to issue a license, if the reason for revocation or non-renewal continues to exist.

(9) Upon revocation or non-renewal, a license holder shall return the original license to the department.

(10) The procedures for revocation, suspension, probation, or denial of a license shall be in accordance with §139.32 of this title.

(e) Failure to timely renew a license.

(1) If a licensee fails to timely renew a license in accordance with subsection (d) of this section, the department shall notify the licensee that the facility shall cease operation on the expiration date of the license.

(2) To continue providing services at the abortion facility after the expiration of the license, the owner shall apply for an initial license in accordance with subsection (c) of this section.

(f) Frequency of inspections. Inspections of the abortion facility shall be performed at a frequency prescribed by and in accordance with §139.31 of this title.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902282

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER C. ENFORCEMENT

25 TAC §§139.31 - 139.33

STATUTORY AUTHORITY

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902283

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

25 TAC §§139.31 - 139.33

STATUTORY AUTHORITY

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902284

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER D. MINIMUM STANDARDS FOR LICENSED ABORTION FACILITIES

25 TAC §§139.41 - 139.60

STATUTORY AUTHORITY

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902285

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972

25 TAC §§139.41 - 139.60

STATUTORY AUTHORITY

§139.46.Licensed Abortion Facility Staffing Requirements and Qualifications.

A licensed abortion facility shall have an adequate number of personnel qualified under this section available to provide direct patient care as needed by all patients; and administrative and nonclinical services needed to maintain the operation of the facility in accordance with the provisions of the Act and this chapter.

(1) Medical consultant. The medical consultant shall be a physician.

(2) Administrator.

(A) The administrator shall be at least 18 years of age, and shall meet at least one of the following qualifications:

(i) be a licensed health care professional;

(ii) have a baccalaureate degree, a postgraduate degree, or a professional degree and one year administrative experience in a health care or health-related field; or

(iii) have a minimum of two years of administrative experience in a health care or health-related facility.

(B) The administrator shall not have been employed in the last year as an administrator with another abortion facility or health-related facility at the time the facility was cited for violations of a licensing law or rule which resulted in enforcement action taken against the abortion facility or health-related facility. For purposes of this subparagraph only, the term "enforcement action" means license revocation, suspension, emergency suspension, probation, denial or injunctive action, but does not include administrative penalties or civil penalties. If 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 the department does not prevail in the second enforcement action (e.g., the facility prevails), the prohibition in this paragraph does not apply.

(C) The administrator shall not have been convicted of a felony or misdemeanor listed in §139.32 of this title (relating to License Denial, Suspension, Probation, or Revocation).

(3) Direct patient care staff.

(A) Medical staff. The medical staff shall include a physician and may include an advanced practice registered nurse or a physician assistant.

(B) Nursing staff. The nursing staff shall include a registered nurse(s) or a licensed vocational nurse(s).

(C) Education and information staff. Staff providing education and information services at the facility shall be a person(s) who is trained to provide information on surgical abortion procedures, medical abortions, alternatives to abortion, consent form, and family planning services, and meets at least one of the following additional qualifications:

(i) has one year experience in a health care facility;

(ii) has a baccalaureate degree; or

(iii) is a licensed professional mental health practitioner who provides therapeutic intervention.

(D) Laboratory staff. The laboratory staff shall include a person(s) who is trained to provide the laboratory services for the facility as determined by the medical consultant.

(4) Ancillary staff. Ancillary staff may include professional or nonprofessional staff who shall have training and experience to perform duties as prescribed by the administrator and the medical consultant as needed.

§139.47.Licensed Abortion Facility Administration.

(a) The administrator shall be responsible for implementing and supervising the administrative policies of the facility.

(b) The administrator shall:

(1) employ a qualified staff adequate in number to:

(A) provide the medical and clinical services;

(B) provide the nonclinical services; and

(2) ensure that employment of personnel is without regard to age, race, color, religion, national origin, sex, or disability;

(3) ensure that all medical and clinical personnel hold current Texas licenses to practice their respective disciplines/professions, if applicable;

(4) develop and make available to all staff and the department, a policy and procedure manual including protocols and description of the roles and responsibilities of all personnel;

(5) ensure that assignment of duties and functions to each employee are commensurate with his/her licensure, certification, and experience and competence;

(6) ensure that staff receive training, education, and orientation to their specific job description, facility personnel policies, philosophy, and emergency procedures in accordance with this section;

(7) schedule employee evaluations;

(8) maintain employee and patient records;

(9) ensure the accuracy of public education information materials and activities in relation to abortion, birth control, and sexually-transmitted diseases. The department shall be the primary resource for human immunodeficiency virus (HIV) education, prevention, risk reduction materials, policies, and information. Educational materials may be obtained by writing or calling the Department of State Health Services Warehouse, Literature and Forms, 1100 West 49th Street Austin, Texas 78756, (512) 458-7761;

(10) implement an effective budgeting, accounting, and auditing system for receipt of state or federal funds;

(11) ensure that all advertisements for the facility include the unique identifying license number assigned by the department in accordance with §139.7 of this title (relating to Unique Identifying Number; Disclosure in Advertisement);

(12) ensure that a woman on whom the abortion is to be performed, at the time of initial on-site consultation, receives the information required to be disclosed under §139.50 of this title (relating to Disclosure Requirements); and

(13) ensure that the reporting requirements of §139.4 of this title (relating to Annual Reporting Requirements for All Abortions Performed) are performed.

(c) A licensed abortion facility shall report violations of practice acts and conditions of license for its licensed health care professional(s) to the appropriate licensing board. If the patient is unsatisfied with the facility's findings, the facility shall provide the complainant with the name, address, and telephone number of the appropriate licensing board. The facility shall document the review and action taken by the facility.

§139.48.Physical and Environmental Requirements.

The physical and environmental requirements for a licensed abortion facility are as follows.

(1) A facility shall:

(A) have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients and staff at all times;

(B) equip each procedure room so that procedures can be performed in a manner that assures the physical safety of all individuals in the area;

(C) have a separate recovery room if moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia are administered at the facility;

(D) have a written protocol for emergency evacuation for fire and other disasters tailored to the facility's geographic location. Each staff member employed by or under contract with the facility shall be able to demonstrate their role or responsibility to implement the facility's emergency evacuation protocol required by this subparagraph;

(E) store hazardous cleaning solutions and compounds in a secure manner and label substances;

(F) have the capacity to provide patients with liquids. The facility may provide commercially packaged food to patients in individual servings. If other food is provided by the facility, it shall be subject to the requirements of §§229.161 - 229.171 of this title (relating to Texas Food Establishments);

(G) provide clean hand washing facilities for patients and staff including running water, and soap;

(H) have two functioning sinks and a functioning toilet; and

(I) have equipment available to sterilize instruments, equipment, and supplies in accordance with §139.49(d) of this title (relating to Infection Control Standards) before use in the facility.

(2) The equipment for vacuum aspiration shall be electrically safe and designed to prevent reverse pump action in facilities that provide vacuum aspiration.

(3) Projects involving alterations of and additions to existing buildings shall be programmed and phased so that on-site construction shall minimize disruptions of existing functions. Access, exit ways, and fire protection shall be maintained so that the safety of the occupants shall not be jeopardized during construction.

§139.49.Infection Control Standards.

(a) Written policies. A licensed abortion facility shall develop, implement, and enforce infection control policies and procedures to minimize the transmission of post-procedure infections. These policies shall include, but not be limited to, the prevention of the transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Mycobacterium tuberculosis (TB), and Streptococcus species (S. spp.); educational course requirements; cleaning and laundry requirements; and decontamination, disinfection, sterilization, and storage of sterile supplies.

(b) Prevention and control of the transmission of HIV, HBV, HCV, TB, and S. spp.

(1) Universal/standard precautions.

(A) An abortion facility shall ensure that all staff comply with universal/standard precautions as defined in this paragraph.

(i) Universal/standard precautions includes procedures for disinfection and sterilization of reusable medical devices and the appropriate use of infection control, including hand washing, the use of protective barriers, and the use and disposal of needles and other sharp instruments.

(ii) Universal/standard precautions synthesize the major points of universal precautions with the points of body substance precautions and apply them to all patients receiving care in facilities, regardless of their diagnosis or presumed infection status.

(I) Universal/standard precautions apply to:

(-a-) blood;

(-b-) body fluids, secretions, and excretions except sweat, regardless of whether or not they contain visible blood;

(-c-) nonintact skin; and

(-d-) mucous membranes.

(II) Universal/standard precautions are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in facilities.

(B) A licensed abortion facility shall establish procedures for monitoring compliance with universal/standard precautions described in subparagraph (A) of this paragraph.

(2) Health care workers infected with the HIV or HBV. A licensed abortion facility shall adopt, implement, and enforce a written policy to ensure compliance of the facility and all of the health care workers within the facility with the Health and Safety Code, Chapter 85, Subchapter I, concerning the prevention of the transmission of HIV and HBV by infected health care workers.

(3) Educational course work and training. A licensed abortion facility shall require its health care workers to complete educational course work or training in infection control and barrier precautions, including basic concepts of disease transmission, scientifically accepted principles and practices for infection control and engineering and work practice controls. To fulfill the requirements of this paragraph, course work and training may include formal education courses or in-house training or workshops provided by the facility. The course work and training shall include, but not be limited to:

(A) HIV infection prevention; and

(B) HBV, HCV, TB, and S. spp. infection prevention based on universal/standard precautions as defined in paragraph (1) of this subsection;

(D) epidemic control.

(1) A licensed abortion facility shall develop, implement, and enforce written policies and procedures on cleaning the procedure room(s).

(2) A licensed abortion facility shall develop, implement, and enforce written policies and procedures for the handling, processing, storing, and transporting of clean and dirty laundry.

(3) A licensed abortion facility may provide cleaning and laundry services directly or by contract in accordance with Occupational Safety and Health Administration's Standards, 29 Code of Federal Regulations, Subpart Z. Bloodborne Pathogens.

(d) Policies and procedures for decontamination, disinfection, sterilization, and storage of sterile supplies. A licensed abortion facility shall have written policies covering its procedures for the decontamination and sterilization activities performed. Policies shall include, but not be limited to, the receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of critical items (reusable items), as well as those for the assembly, wrapping, storage, distribution, and the monitoring and control of sterile items and equipment.

(1) Supervision. The decontamination, disinfection, and sterilization of all supplies and equipment shall be under the supervision of a person qualified by education, training, or experience.

(2) Quantity of sterile surgical instruments. The facility shall ensure that surgical instruments are sufficient in number to permit sterilization of the instrument(s) used for each procedure and adequate to perform conventional cervical dilatation and curettage if this procedure is available at the facility.

(3) Inspection of surgical instruments.

(A) All instruments shall undergo inspection before being packaged for reuse or storage. Routine inspection of instruments shall be made to assure clean locks, crevices, and serrations.

(B) Inspection procedures shall be thorough and include visual and manual inspection for condition and function.

(i) Cutting edges shall be checked for sharpness; tips shall be properly aligned, and box locks shall be clean and free from buildup of soap, detergent, dried blood, or tissue.

(ii) There shall be no evident cracks or fissures in the box locks, and the hinges shall work freely.

(iii) Ratchets shall hold and be routinely tested.

(iv) There shall be no corrosion or pitting of the finish.

(C) Instruments needing maintenance shall be taken out of service and repaired by someone qualified to repair surgical instruments.

(D) To protect the instrument and its protective finish, impact markers or electric engravers shall not be used for instrument identification. Instrument identification shall be accomplished by the instrument manufacturer, employing methods which shall not damage the instrument or its protective finish.

(4) Items to be disinfected and sterilized.

(A) Critical items.

(i) Critical items include all surgical instruments and objects that are introduced directly into the bloodstream or into other normally sterile areas of the body and shall be sterilized in accordance with this subsection.

(ii) All items that come in contact with the sterile field during the operative procedure shall be sterile.

(B) Semicritical items.

(i) Semicritical items include items that come in contact with nonintact skin or mucous membranes. Semicritical items shall be free of microorganisms, except bacterial spores. Semicritical items may include respiratory therapy equipment, anesthesia equipment, bronchoscopes, and thermometers.

(ii) High-level disinfection shall be used for semicritical items.

(i) Noncritical items include items that come in contact with intact skin.

(ii) Intermediate-level or low-level disinfection shall be used for noncritical items.

(5) Equipment and sterilization procedures. Effective sterilization of instruments depends on performing correct methods of cleaning, packaging, arrangement of items in the sterilizer, and storage. The following procedures shall be included in the written policies as required in this subsection to provide effective sterilization measures.

(A) Equipment. A licensed abortion facility shall provide sterilization equipment adequate to meet the requirements of this paragraph for sterilization of critical items. Equipment shall be maintained and operated to perform, with accuracy, the sterilization of critical items.

(B) Environmental requirements. Where cleaning, preparation, and sterilization functions are performed in the same room or unit, the physical facilities, equipment, and the written policies and procedures for their use shall be such as to effectively separate soiled or contaminated supplies and equipment from the clean or sterilized supplies and equipment.

(i) A facility shall have a sink for hand washing. This sink shall not be used for cleaning instruments or disposal of liquid waste.

(ii) A facility shall have a separate sink for cleaning instruments and disposal of liquid waste. Hand washing shall only be performed at this sink after it has been disinfected.

(i) All items to be sterilized shall be prepared to reduce the bioburden. All items shall be thoroughly cleaned, decontaminated and prepared in a clean, controlled environment. Cleaning is the removal of all adherent visible soil from the surfaces, crevices, joints, and lumens of instruments. Decontamination is the physical/chemical process that renders an inanimate object safe for further handling.

(ii) One of the following methods of cleaning and decontamination shall be used as appropriate.

(I) Manual cleaning. Manual cleaning of instruments at the sink is permitted.

(II) Ultrasonic cleaning. Ultrasonic cleaning of instruments cleans by cavitation and reduces the need for hand scrubbing. When grossly soiled items are placed in the ultrasonic cleaner the water shall be changed more than once a shift. If using this method for cleaning, chambers shall be covered to prevent potential hazards to personnel from aerosolization of the contents.

(III) Washer-sterilizers. Washer-sterilizers clean by using rotating spray arms to create water jets that clean by impingement and appropriate soap and disinfectant. These machines shall reach a temperature of 140 degrees Celsius (285 degrees Fahrenheit).

(IV) Washer-decontaminator machines. Washer-decontaminator machines clean by numerous water jets and a high pH of detergent even if instruments are grossly soiled. The thorough cleaning is followed by a neutralizing rinse to quickly restore the pH to neutral.

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

(D) Packaging.

(i) All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized, and to provide an effective barrier to microorganisms. Acceptable packaging includes peel pouches, perforated metal trays, or rigid trays. Muslin packs shall be limited in size to 12 inches by 12 inches by 20 inches with a maximum weight of 12 pounds. Wrapped instrument trays shall not exceed 17 pounds.

(ii) All items shall be labeled for each sterilizer load as to the date and time of sterilization, the sterilizing load number, and the autoclave.

(E) External chemical indicators.

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

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

(F) Biological indicators.

(i) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used (e.g., Bacillus stearothermophilus for steam sterilizers).

(ii) Biological indicators shall be included in at least one run each day of use for steam sterilizers.

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

(iv) If a test is positive, the sterilizer shall immediately be taken out of service. A malfunctioning sterilizer shall not be put back into use until it has been serviced and successfully tested according to the manufacturer's recommendations.

(v) All available items shall be recalled and reprocessed if a sterilizer malfunction is found. A list of all items which were used after the last negative biological indicator test shall be submitted to the administrator.

(G) Sterilizers.

(i) Steam sterilizers (saturated steam under pressure) shall be utilized for sterilization of heat and moisture stable items. Steam sterilizers shall be used according to manufacturer's written instructions.

(ii) Other sterilizers shall be used in accordance with the manufacturer's instructions.

(H) Maintenance of sterility.

(i) Items that are properly packaged and sterilized shall remain sterile indefinitely unless the package becomes wet or torn, has a broken seal, is damaged in some way, or is suspected of being compromised.

(ii) Medication or materials within a package that deteriorate with the passage of time shall be dated according to the manufacturer's recommendations.

(iii) All packages shall be inspected before use. If a package is torn, wet, discolored, has a broken seal, or is damaged, the item may not be used. The item shall be returned to sterile processing for reprocessing.

(I) Commercially packaged items. Commercially packaged items are considered sterile according to the manufacturer's instructions.

(J) Storage of sterilized items. The loss of sterility is event related, not time related. The facility shall ensure proper storage and handling of items in a manner that does not compromise the packaging of the product.

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

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

(iii) Sterilized items shall be positioned so that the packaging is not crushed, bent, compressed, or punctured so that their sterility is not compromised.

(iv) Storage of supplies shall be in areas that are designated for storage.

(K) Disinfection.

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

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

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

(L) Performance records.

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

(ii) Each sterilizer shall be monitored during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained either manually or machine generated and shall include:

(I) the sterilizer identification;

(II) sterilization date and time;

(III) load number;

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

(V) identification of operator(s);

(VI) results of biological tests and dates performed; and

(VII) time-temperature recording charts from each sterilizer (if not provided on sterilizer recording charts).

(M) Preventive maintenance. Preventive maintenance of all sterilizers shall be performed according to individual policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review to the facility within two hours of request by the department.

§139.51.Patient Rights at the Facility.

A licensed abortion facility shall ensure that all women on whom the abortion is to be performed:

(1) be allowed to make her own choice and self-determination;

(2) are ensured the right to personal privacy and confidentiality of her choices and decisions;

(3) are ensured the right to voluntary and informed consent as defined in Health and Safety Code, §171.012, without paying a fee for the informational materials;

(4) are ensured individual counseling concerning private medical information and to be given a private opportunity to ask questions;

(5) be allowed to view their medical record, including the sonogram, if one has been performed, at any time as provided by law;

(6) have access to care and treatment consistent with available resources and generally accepted standards regardless of race, color, national origin, age, sex, religion or disability;

(7) are allowed to ask additional questions after giving consent and to withdraw consent while still medically safe to do so;

(8) are provided freedom from abuse, neglect, or exploitation as those terms are defined in §1.204 of this title (relating to Abuse, Neglect, and Exploitation Defined); and

(9) be allowed to review the department's informational materials as described in Health and Safety Code, §171.014 and §171.015.

§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 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.

(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;

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

(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.

§139.54.Health Care Services.

(a) Definition. For the purposes of this section, the term "health care professional" includes:

(1) a physician;

(2) an advanced practice registered nurse;

(3) a physician assistant;

(4) a registered nurse;

(5) a licensed vocational nurse; or

(6) a licensed mental health practitioner.

(b) Licensed health care professionals.

(1) A licensed abortion facility shall ensure that its licensed health care professionals practice within the scope of their practice and within the constraints of applicable state laws and regulations governing their practice and follow the facility's written policies and procedures.

(2) A licensed abortion facility may allow physicians to train nonlicensed personnel, age 18 years or above, to extract blood for laboratory testing and to administer intravenous fluids.

(c) Student health care professionals. If the facility has a contract or agreement with an accredited school of health care to use their facility for a portion of the students' clinical experience, those students may provide care under the following conditions.

(1) Students may be used in facilities, provided the instructor gives class supervision and assumes responsibility for all student activities occurring within the facility. If the student is licensed, such as a licensed vocational nurse attending a registered nurse program for licensure as a registered nurse, the facility shall ensure that the administration of any medication(s) is within the student's licensed scope of practice.

(2) All instruction shall be provided by the school's instructor or his or her designee.

(3) A student may administer medications only if:

(A) on assignment as a student of their school of health care; and

(B) the instructor is on the premises and directly supervises the administration of medication by an unlicensed student, and the administration of such medication is within the instructor's licensed scope of practice.

(4) Students shall not be used to fulfill the requirement for administration of medications by licensed personnel.

(5) Students shall not be considered when determining staffing needs required by the facility.

§139.57.Discharge and Follow-up Referrals.

(a) A licensed abortion facility shall develop and implement written discharge instructions which shall include:

(1) a list of complications (developed by the facility in conjunction with a physician who practices in the facility) that warrant the patient contacting the facility, which shall include, but not be limited to:

(A) pain;

(B) fever; and

(2) a statement of the facility's plan to respond to the patient in the event the patient experiences any of the complications listed in the discharge instructions to include:

(A) the mechanism by which the patient may contact the facility on a 24-hour basis by telephone answering machine or service, or by direct contact with an individual;

(B) the facility's requirement that every reasonable effort be made and documented to respond to the patient within 30 minutes of the patient's call;

(C) assurance that the responding individual shall be a physician, advanced practice registered nurse, physician assistant, registered nurse, or licensed vocational nurse; and

(D) information that the patient may also contact the emergency medical service or present for care at the emergency room of a hospital in addition to contacting the facility; and

(3) information concerning the need for a post-abortion examination.

(b) A facility shall provide a patient with a copy of the written discharge instructions described in subsection (a) of this section.

(1) examination or referral of all patients who report complications, as identified in the list required by subsection (a)(1) of this section, to the facility after an abortion procedure. The written policy and procedure shall require:

(A) the facility to maintain a written system of documentation of patients who report post-abortion complications within 14 days of the procedure date;

(B) documentation of the facility's action following a patient's reporting of post-abortion complications to be placed in the patient's record; and

(C) the patients' records to be maintained for adults for seven years and for minors five years past the age the patient reaches majority; and

(2) periodic review of the record keeping system for post-abortion complications to identify problems and potential problems and to make changes in order to resolve the problems.

§139.59.Anesthesia Services.

(a) Anesthesia services, when provided in the abortion facility, shall be limited to those that are approved by the governing body, which may include the following:

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

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

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

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

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

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

(7) General anesthesia--A drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

(b) An anesthesia department shall be required if moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia are administered at the facility and shall be under the medical direction of a physician approved by the governing body upon the recommendation of the abortion facility medical staff.

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

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

(1) verify that the registered nurse has the requisite training, education, and experience;

(2) maintain documentation to support that the registered nurse has demonstrated competency in the administration of sedation;

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

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

(e) Anesthesia shall not be administered unless the operating surgeon has evaluated the patient immediately prior to the procedure to assess the risk of the anesthesia and of the procedure to be performed.

(f) The CRNA, the anesthesiologist, or the operating surgeon shall be available until all of his or her patients operated on that day have been discharged from the recovery room.

(g) Patients who have received anesthesia shall be evaluated for proper anesthesia recovery by the operating surgeon or the person administering the anesthesia prior to discharge from the recovery room using criteria approved by the medical staff.

(h) Patients who remain in the facility for extended observation following discharge from the recovery room shall be evaluated immediately prior to leaving the facility by a physician, the person administering the anesthesia, or a registered nurse acting in accordance with physician's orders and written policies, procedures and criteria developed by the medical staff.

(i) A physician shall be on call and able to respond physically or by telephone within 30 minutes until all patients have been discharged from the abortion facility.

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

(1) Functioning equipment and supplies which are required for all facilities include:

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

(B) source of compressed oxygen;

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

(D) blood pressure monitoring equipment; and

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

(2) In addition to the equipment and supplies required under paragraph (1) of this subsection, facilities which provide moderate sedation/analgesia, deep sedation/analgesia, regional analgesia and/or general anesthesia shall provide the following:

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

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

(D) electrocardiographic monitoring equipment;

(E) cardiac defibrillator; and

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

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on June 8, 2009.

TRD-200902286

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 28, 2009

Proposal publication date: December 19, 2008

For further information, please call: (512) 458-7111 x6972