TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 139. ABORTION FACILITY REPORTING AND LICENSING

The Texas Department of Health (department) adopts amendments to §§139.1-139.8, 139.21-139.25, 139.31-139.33, and 139.41-139.60, and the repeal of §139.34, concerning the regulation of abortion facilities. Sections 139.2, 139.6, 139.22, 139.23, 139.31-139.32, 139.41, 139.43, 139.50-139.52 and 139.58-139.59 are adopted with changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10051). Sections 139.1, 139.3-139.5, 139.7-139.8, 139.21, 139.24-139.25, 139.33, 139.42, 139.44-139.49, 139.53-139.57, and 139.60, and the repealed §139.34 are adopted without changes, and therefore the sections will not be republished.

The amendments are adopted based upon the department's review of 25 Texas Administrative Code, Chapter 139, as required by Government Code, §2001.039 and as required by legislation that affects the regulation of non-exempt abortion facilities.

Specifically, the amendment to §139.1 clarifies the reporting requirements for an abortion facility and defines exemptions for licensing requirements for abortion facilities. The amendment to §139.2 adds definitions, clarifies others, and deletes some definitions. The definitions were renumbered as necessary to reflect the changes. Amendments to §§139.3 and 139.4 add and delete language to better enable the department to enforce the requirements of these sections and for clarification purposes. The amendment to §139.5 adds probation to types of possible enforcement action that may be taken by the department, and updates language to reflect current statutes. The amendment to §139.6 deletes the requirement that violations not be disclosed that would pose a health risk until plans of correction have been submitted, changes "survey" to "inspection", and reflects current statutes. The amendment to §139.7 clarifies the intent of the section by adding "licensed" to abortion facilities, and deletes the requirement that the issuance of the unique license number may not coincide with the deadlines established by advertisers. The amendment to §139.8 deletes the requirement concerning facility quality assurance committee records.

The amendments to §§139.21, 139.22, and 139.23 add requirements for two-year licensure, a process for ordering probation as a sanction, and for an annual assessment fee to cover additional costs for Health and Safety Code, Chapter 171. Requirements for the first annual license, current letter from the state comptroller's office, and active military exception are deleted, simplifying the licensure process. The amendment to §139.24 adds the word "licensed" to "abortion facility," and substitutes the words "pre-inspection" and "inspection" for "pre-survey" and "survey" for clarification. The amendment also deletes the requirement to submit a license application for relocation of a facility; and adds a requirement for policies to address the preservation and release of medical records in the event a facility closes.

The amendment to §139.25 deletes language for first annual license to reflect changes to initial licensing procedures. The amendment to §139.31 replaces the word "survey" with "inspection"; adds the word "licensed" to "abortion facility"; adds the requirement that all on-site inspections will be unannounced; deletes specific department survey procedure language; and changes inspection processing times from five to 14 calendar days. Other changes are for clarity, and portions are deleted to reflect current departmental procedure.

The amendments to §§139.32 and 139.33 and the repeal of §139.34 add and delete language in order to clarify the department's enforcement process.

The amendments to §§139.41 - 139.45 add and delete language for clarification. Specific language is added to reflect new legislative requirements and to ensure compliance with existing governmental requirements. Language requiring compliance concerning the prohibition of illegal remuneration for securing or soliciting patients or patronage is deleted from this section because regulations prohibiting solicitation are now located in Occupations Code, Chapter 102. New language for compliance with this is added to §139.60. The amendments to §139.46 add "midlevel provider" and delete "physician extender" to reflect current terminology, delete the requirement that laboratory staff have a high school education, and change the wording for anesthesia staff to reflect current terminology.

Amendments to §§139.47 -139.49 change language to reflect current definitions, to reflect current standards of practice, and to delete obsolete language and policies.

The amendments to §139.50 add requirements for the facility to comply with the Health and Safety Code, Chapter 171. Additional language is added for clarification.

The amendments to §139.51 add language to meet requirements as described in Health and Safety Code, §§171.014 and 171.015 concerning informational materials and information relating to public and private agencies.

The amendment to §139.52 expands requirements for patient education/information services to ensure compliance with Health and Safety Code, §§171.011 and 171.012, concerning informed consent, and deletes obsolete language.

The amendment to §139.53 adds new language, and renumbers the section based on the separation of surgical and medical abortion requirements. Amendments also incorporate use of current terminology.

The amendment to §139.54 reflects the changed designation of licensed abortion facilities and certain staff positions. The amendment to §139.55 clarifies requirements for entry of information and retrieval of records by the facility, and clarifies requirements concerning documentation by facility in the patient's clinical record.

Language added to §139.57 and §139.58 defines medical record retention requirements and incorporates the term "licensed abortion facility." The amendment to §139.59 adds and deletes language to reflect current standards of practice for anesthesia services and to enable the department to better enforce this section. Training, knowledge, and staffing requirements are added.

The amendment to §139.60 includes language to reflect current standards of practice and revised statutory citations. Additional requirements were added in the areas of medical services and first aid, parental notice, and the facility's duty to assure staff compliance with current state and federal laws.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The sections have been reviewed and the department has determined that reasons for adopting the sections continue to exist. However, revisions to the sections are necessary.

The department published a Notice of Intention to Review for §§139.1-139.8, 139.21-139.25, 139.31-139.34 and 139.41-139.60 in the Texas Register in the July 18, 2003, issue (28 Tex Reg 5667). No comments were received due to publication of this notice.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting change(s).

Comment: Concerning the rules in general, some commenters made very general comments opposing the rules, and other commenters made non-specific comments supporting the rules. Many commenters requested the department review all the proposed rules and delete any language that was more restrictive than Health and Safety Code, Chapters 245 and 171.

Response: Health and Safety Code, Chapter 245, gives the department broad authority to develop minimum standards for abortion facilities. The department did review the proposed rules to ensure that the rules were consistent with the regulatory authority granted under Health and Safety Code, Chapters 245 and 171, and some changes were made, as discussed later in this preamble.

Comment: Concerning the rules in general, a commenter requested the department adopt a rule requiring abortion facilities to provide a copy of a minor's medical record to the minor's parents.

Response: The department disagrees. Parents of married minors and those minors who have had their legal disabilities removed are not entitled to obtain such a minor's medical record. The department does not have the authority to adopt a rule that requires abortion facilities to provide a copy of every minor's medical record to the minor's parents. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter requested that the department reconsider the proposed change in the definition of an abortion facility. The commenter believes that the definitions in Health and Safety Code, Chapter 245, give the department authority to enforce the chapter in all types of abortion facilities, not just licensed abortion facilities.

Response: The legislature exempted ambulatory surgical centers and certain physician's offices from licensure as abortion facilities under Health and Safety Code, Chapter 245. The department's authority under Health and Safety Code, Chapter 245, applies only to nonexempt facilities. However, the department's rules for abortion facilities have not made the department's interpretation clear. In the light of recent controversy and litigation over this issue, the department feels that a clarification is necessary at this time. The phrase "licensed abortion facility" was added throughout the proposed rules for purposes of distinguishing between the licensed and exempt facilities. The department has also made this change in §139.31(c)(4), and §139.32(k) and (l) in these final rules.

Comment: Concerning the rules in general, many commenters requested the department not adopt a detailed checklist for use by the facilities to document informed consent prior to an abortion procedure. Some commenters requested the department adopt a detailed checklist.

Response: The department disagrees with commenters who requested it not adopt a checklist. The department believes it is important that there be assurance that the woman is informed of each of the required elements of the Woman's Right to Know Act on the certification form. Therefore, the form has been revised to include a space where the woman will place her initials to acknowledge that the information listed on the form was provided.

Comment: Concerning the rules in general, one commenter requested that the department adopt a rule that required all abortion facility personnel to be subjected to a security check.

Response: The department disagrees. The statute does not authorize the adoption of a rule requiring security or criminal history checks of facility personnel. No changes were made as a result of this comment.

Comment: Concerning §139.2, one commenter recommended the department add a definition for nurse practitioner.

Response: The department agrees and has added the requested definition in renumbered §139.2(37).

Comment: Concerning §139.2(12), one commenter recommended the language in the definition of "Certified registered nurse anesthetist (CRNA)" be changed. The commenter suggested replacing the phrase "currently registered with" with the phrase "currently authorized by" and replacing the phrase "advanced nurse practitioner" with the phrase "certified registered nurse anesthetist".

Response: The department agrees and has made the recommended changes.

Comment: Concerning §139.6, one commenter requested that the department change the language pertaining to providing the woman with the toll-free telephone number from "at the time of the initial onsite consultation with the facility" to "at the time of the initial onsite consultation."

Response: The department disagrees. The language in Health and Safety Code, §245.042(d), specifies that the "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 line maintained under subsection (c)." No change was made as a result of the comment.

Comment: Concerning §139.21(i), one commenter recommended that the rule authorizing the department to assess a reasonable and necessary annual fee to defray costs be revised to clearly state that this fee would only reflect costs which were not related to the production and distribution of the Woman's Right to Know materials. The commenter believed the assessment of a fee to cover the costs of the materials required by Health and Safety Code, Chapter 171, would be unconstitutional.

Response: The department disagrees. Health and Safety Code, §245.007, expressly grants the department authority to set fees in amounts reasonable and necessary to defray the cost of administering Health and Safety Code Chapter 171. No change was made as a result of the comment.

Comment: Concerning §139.41(a)(8), which would require that a woman's identification be copied or that an affidavit be provided, many commenters stated the rule exceeds the requirements of Family Code, Chapter 33, and recommended the rule be deleted. There were also many commenters who supported the rule as proposed. One commenter noted that the statement in proposed §139.41(a)(8)(A) "...indicating that she does not have appropriate identification...", is not the same as the wording on the attached affidavit which states, "...I do not own identification."

Response: The department disagrees with commenters who recommend deletion of the rule. The department believes that retention of a copy of the identification presented is an appropriate method of documenting facilities' compliance with the parental notification requirements of Family Code, Chapter 33. The department agrees with the commenter regarding the wording of the affidavit, and the language in the affidavit form has been revised for consistency with §139.41(a)(8)(B).

Comment: Concerning §139.43(6), one commenter requested the department add the American Safety and Health Institute to the organizations listed in the paragraph that provide certification in basic life support.

Response: The department agrees and has added the name of the organization as requested.

Comment: Concerning §139.43(8), one commenter requested that the department specify that the required training on child abuse to be completed by all personnel must be the training which is developed jointly by the department and the Department of Protective and Regulatory Services.

Response: The department agrees, and has included this clarifying language in the final rule.

Comment: Concerning proposed §139.50(b)(2), many of the commenters stated that the proposed rule exceeded the language and intent of HSC, Chapter 171, by requiring that every woman receive a copy of the department's A Woman's Right to Know booklet which is now in relettered §139.50(a)(3). There were also many commenters who supported the rule as proposed.

Response: The department disagrees with the commenters who opposed the rule as proposed. The Merriam-Webster Collegiate Dictionary, Tenth Edition, defines the word "provide" as "to supply or make available." The rule only requires that the facility provide the woman with a copy of the department's A Woman's Right to Know booklet. The woman makes the decision to either accept the booklet or refuse it. Additional language has been included in the final rule to clarify that the woman must also be given the option of viewing the material on the Internet in §139.50(a)(5).

Comment: Concerning proposed §139.50(b)(3), many of the commenters stated that the proposed rule exceeded the language and intent of HSC, Chapter 171, by requiring that every woman receive a copy of the Woman's Right to Know resource directory. There were also many commenters who supported the rule as proposed.

Response: The department disagrees with the commenters who opposed the rule as proposed. The Merriam-Webster Collegiate Dictionary, Tenth Edition, defines the word "provide" as "to supply or make available." The rule only requires that the facility provide the woman with a copy of the department's Woman's Right to Know resource directory in relettered §139.50(a)(4). The woman makes the decision to either accept the resource directory or refuse it. Additional language has been included in the final rule to clarify that the woman must also be given the option of viewing the material on the Internet in §139.50(a)(5).

Comment: Concerning §139.51, one commenter requested that the department add to the rule a requirement which would prohibit the abortion facility from charging any fees before the 24-hour waiting period was over.

Response: The department disagrees. The department has no statutory authority to regulate the fees charged by any licensed facility. No change was made as a result of the comment.

Comment: Concerning §139.51(5), one commenter stated that it is important for a woman know that a sonogram is part of her medical record and that she has the right to see it. The commenter requested the department add the words "including her sonogram" to the rule.

Response: The department agrees and has added the requested language.

Comment: Concerning §139.52 in general, one commenter requested that the department restore the rule proposed for deletion that required the facility to "establish that the patient understands the nature and consequences of the procedure and recognizes alternatives to abortions."

Response: The department disagrees. This rule was amended because the determination of a patient's understanding is subjective, and not measurable, so there was no mechanism by which the facility could demonstrate compliance with the rule. No change was made as a result of the comment.

Comment: Concerning §139.52(a)(1), which requires that the woman sign the department's certification form prior to the abortion procedure, one commenter requested that the department add a requirement that the patient must receive a copy of the "consent form".

Response: The department does not believe the addition of this language is necessary. The form required in the rule is a certification form, not a consent form. The certification form is considered part of the clinical record, and if the patient requests a copy of the form, the facility will be expected to provide it. No change was made as a result of the comment.

Comment: Concerning Figure: 25 TAC, §139.52(a)(1), one commenter requested that the department change the term "unborn child" to "human fetus" on the certification form.

Response: The department disagrees as the term "unborn child" is the term used in HSC, Chapter 171. No change was made as a result of the comment.

Comment: Concerning §139.52(a)(4), many of the commenters requested that the proposed rule relating to taking all reasonable steps to maintain the life of the unborn child be deleted because the vast majority of abortions are performed in the first trimester, well before viability, and there is no such requirement in Texas law. There were also many commenters who supported the rule as proposed.

Response: The department believes that the determination of viability is a medical practice issue. Clarifying language has been added to the rule to allow the physician to determine at what point it would be medically appropriate to advise the patient of the physician's responsibilities to maintain the life and health of the child if born alive.

Comment: Concerning §139.53(b)(3)(A), one commenter requested the word "prescribing" be substituted for the word "providing" in the rule.

Response: The department disagrees based on the consensus of medical physician consultants, and language used in medical literature describing early medical abortion. No change was made as a result of the comment.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning the Spanish version form for the toll-free telephone number in §139.6(a)(2), the wording was not changed, but the last statement was indented to be consistent with the English version of the form in §139.6(a)(1).

Change: Concerning §139.22(g), the department has included language that reflects the authorization provided by Texas Government Code, §2054.111, to collect subscription and convenience fees for processing initial and renewal applications through TexasOnline.

Change: Concerning §139.23(d)(5)(B)(iv), the word "that" was inserted after the word "ensure" for clarity.

Change: Concerning §139.32(e)-(g), the department changed the word "center" to "facility" to reflect the terminology used throughout the chapter.

Change: Concerning §139.32(l), the word "Code" was added to complete the title of the Health and Safety Code.

Change: Concerning §139.50, the department has reorganized the section for the purpose of clarity. In addition, the department removed the requirement specifying that the initial consultation must be done onsite, which will allow for alternate methods of accomplishing the disclosure requirements. If the initial consultation is not conducted onsite, the facility will still be required to provide the written notifications and disclosures required in §139.50. These may be provided by email, facsimile transmission, or they may be sent by conventional mail. If the written notifications and Woman's Right to Know materials are sent by conventional mail, the abortion procedure cannot be scheduled until a minimum of 72 hours later. The facility will be required to document in the clinical record the method by which the required information was provided to the woman, the date and time it was provided, and the name and credentials of the facility representative providing it. This documentation will be used in the compliance monitoring of the facility during inspection. Also, in §139.50(a)(3) and (4), concerning "A Woman's Right to Know" booklet, the statement "if the woman chooses to view it." was added by the Board of Health.

Change: Concerning §139.58, the department changed the word "women's" to "woman's" as a correction.

Change: Concerning §139.59(e)(3), the department added the word "in" as a correction.

Change: Concerning Figure: 25 TAC, §139.52(a)(1), the Certification Form was reorganized to more clearly delineate the disclosure responsibilities of both the physician and the facility, and to include a line next to each item for the woman to confirm that the required information was provided.

The commenters included Senator Juan "Chuy" Hinojosa; Senator Eliot Shapleigh; Senator Jeff Wentworth; Representative Lon Burnam; Representative Frank J. Corte, Jr.; Representative Dawnna Dukes; Representative Jessica Farrar; Representative Elliott Naishtat; Representative Eddie Rodriguez; Representative Senfronia Thompson; Representative Michael M. Villarreal; National Council of Jewish Women, Texas State Public Affairs; Family Life Office Diocese of Fort Worth; Tyler Diocesan Council of Catholic Women of NCCU; Saint Anthony Catholic Church, Wylie, Texas; Texas Right to Life, Houston, Texas; Women's Health and Family Planning Association of Texas, Austin, Texas; Board of Nurse Examiners for the State of Texas; National Instructors Resource Center, ASHI Programs; ACLU Reproductive Freedom Project, New York; Center for Reproductive Rights, New York; Jane's Due Process, Austin; The Justice Foundation, San Antonio; Nova Health System, San Antonio; League of Women Voters of Texas, Austin; Texas Medical Association; Texas Association of Obstetricians and Gynecologists; Texas Association of Planned Parenthood Affiliates; Coalition for Nurses in Advanced Practice; and Project Rachel of San Antonio, Inc. In addition, numerous individuals commented. Commenters were neither for nor against the rules in their entirety; they expressed concerns, asked questions and suggested changes as discussed in the summary of comments.

Subchapter A. GENERAL PROVISIONS

25 TAC §§139.1 - 139.8

The amendments are adopted under the Health and Safety Code, Chapter 245, Health and Safety Code, Chapter 171, and the Health and Safety Code, §12.001, which provide the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these 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--Any act or procedure performed after pregnancy has been medically verified with the intent to cause the termination of a pregnancy other than for the purpose of either the birth of a live fetus or removing a dead fetus. This term does not include birth control devices or oral contraceptives.

(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) 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.

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

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

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

(C) an individual--includes:

(i) the individual's spouse;

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

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

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

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

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

(8) Anniversary Date--The same month and day of each year as the expiration date of the license.

(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 non-profit organization.

(10) Board--The Texas Board of Health.

(11) Certified nurse-midwife (CNM)--A person who is:

(A) a registered nurse who is currently licensed under the Nursing Practice Act, Texas Occupations Code, Chapters 301, and 304;

(B) recognized as an advanced practice nurse by the Board of Nurse Examiners for the State of Texas; and

(C) certified by the American College of Nurse-Midwives (ACNM) or ACNM Accreditation Council.

(12) Certified registered nurse anesthetist (CRNA)--A person who is currently licensed under the Nursing Practice Act, Texas Occupations Code, Chapters 301 and 304, as a registered nurse, has current certification from the Council of Certification-Recertification of the American Association of Nurse Anesthetists, and is currently authorized by the Board of Nurse Examiners as a certified registered nurse anesthetist.

(13) 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.

(14) Clinical nurse specialist--A person who is currently licensed under the Nursing Practice Act, Texas Occupations Code, Chapters 301 and 304, and recognized as a clinical nurse specialist by the Board of Nurse Examiners.

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

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

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

(18) Department--The Texas Department of Health.

(19) Director--The director of the Health Facility Licensing and Compliance Division of the Texas Department of Health or his or her designee.

(20) 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 Food and Drug Administration;

(B) intermediate-level disinfection--kills mycobacteria, most viruses, and bacteria with a chemical germicide registered as a "tuberculocide" by the 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.

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

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

(23) 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.

(24) 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.

(25) 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 conditions of participation for hospitals in Title XVIII, Social Security Act (42 United States Code, §1395 et. seq.).

(26) 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.

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

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

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

(30) Licensed vocational nurse (LVN)--A person who is currently licensed under Texas Occupations Code, Chapter 302, as a licensed vocational nurse.

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

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

(33) Midlevel provider--A midlevel provider is:

(A) an advance practice nurse who is registered currently licensed under the Nurse Practice Act, Texas Occupations Code, Chapters 301 and 304, and is recognized as an advanced practice nurse by the Board of Nurse Examiners (BNE) for the State of Texas. Advanced practice nurses may include, but not be limited to, the following:

(i) certified registered nurse anesthetist;

(ii) certified nurse midwife;

(iii) nurse practitioner;

(iv) clinical nurse specialist; and

(v) other titles as approved by the BNE; or

(B) a physician assistant currently licensed under the Physician Assistant Licensing Act, Texas Occupations Code, Chapter 204.

(34) Nonprofessional personnel--Personnel of the facility who are not licensed or certified under the laws of this state to provide a service and must 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.

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

(36) 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.

(37) Nurse practitioner--A person who is currently licensed under the Nursing Practice Act, Texas Occupations Act, Chapters 301 and 304, and recognized as a nurse practitioner by the Board of Nurse Examiners.

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

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

(40) Physician--An individual who is currently licensed to practice medicine under the Medical Practice Act, Texas Occupations Code, Chapters 151-165.

(41) 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.

(42) Postprocedure infection--An infection acquired at or during an admission to a facility; there must be no evidence that the infection was present or incubating at the time of admission to the facility. Postprocedure 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.

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

(44) 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.

(45) 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.

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

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

(48) Registered nurse (RN)--A person who is currently licensed under the Nursing Practice Act, Texas Occupations Code, Chapters 301 and 304 as a registered nurse.

(49) Sedation/analgesia levels--Levels of sedation /analgesia include:

(A) minimal sedation (anxiolysis);

(B) moderate sedation/analgesia ("conscious sedation");

(C) deep sedation/analgesia; and

(D) general anesthesia.

(50) 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.

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

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

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

(54) 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.

(55) Third trimester certification form--The document prepared by the Texas Department of Health 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.

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

(57) Unemancipated minor--A minor who is unmarried and has not had the disabilities of minority removed under the Texas 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 must 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 §245.023(b) of the Act, the Texas State Board of Medical Examiners (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 who provides services at an abortion facility.

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 January 16, 2004.

TRD-200400345

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Subchapter B. LICENSING PROCEDURES

25 TAC §§139.21 - 139.25

The amendments are adopted under the Health and Safety Code, Chapter 245, Health and Safety Code, Chapter 171, and the Health and Safety Code, §12.001, which provide the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these rules implements Government Code, §2001.039.

§139.22.Fees.

(a) The schedule of fees for an abortion facility license for all new, change of ownership, and renewal applications received prior to January 1, 2005, is as follows:

(1) initial license fee--$2,500;

(2) renewal license fee--$2,500; and

(3) change of ownership license fee--$2,500.

(b) Fees for renewal licenses issued January 1, 2005, through December 31, 2005, will be either $2,500 for one year or $5,000 for two years. The licensure period will be determined by the department prior to the licensure renewal date.

(c) Fees for two-year renewals for an abortion facility license for all initial, change of ownership, and renewal applications received on or after January 1, 2006, are as follows:

(1) initial license fee--$5000;

(2) renewal license fee--$5000; and

(3) change of ownership license fee--$5000.

(d) The department will not consider an application as officially submitted until the applicant pays the applicable licensing fee. The fee must accompany the application form.

(e) A license fee paid to the department is not refundable.

(f) Any remittance submitted to the department in payment of a required license fee must be in the form of a certified check, money order, or personal check made payable to the Texas Department of Health.

(g) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the TexasOnline Authority, to recover costs associated with application and renewal application processing through TexasOnline, in accordance with Texas Government Code, §2054.111.

(h) The department may make periodic reviews of its license fee schedule to ensure that the fees imposed are in amounts reasonable and necessary to defray the cost to the department of administering the Act.

(i) The department will assess an annual assessment fee as follows.

(1) In addition to application fees for initial, renewal, and change of ownership license fees, an annual assessment fee per year will be imposed by the department in amounts reasonable and necessary to defray costs.

(2) The amount of the one time per year annual assessment fee will be determined by the department on an annual basis.

(3) Fees will be divided into three categories based on a three year history:

(A) the average per year of the previous three years reported abortions equals less than 1000;

(B) the average per year of the previous three years reported abortions equals 1000 - 2999;

(C) the average per year of the previous three years reported abortions equals 3000 or more.

(4) Facilities identified in each category will be assessed a proportionate share of the costs.

(5) Licensees receiving an initial license will be assessed the least of the three fees in effect at the time of application for an initial or change of ownership license. The additional annual assessment fee is due at the same time as the application fee.

(6) The department shall notify each licensee of the amount assessed for the annual assessment fee by April 1, 2004, and by the first day of April for each subsequent year.

(7) The annual assessment fee must be received by the department no later than June 1, 2004, and the first day of June for each subsequent year.

(8) A licensee who fails to pay the assessed annual assessment fee will be subject to denial, revocation, probation, or suspension of a license as prescribed in §139.32 of this title (relating to License Denial, Suspension, Probation or Revocation).

§139.23.Application Procedures and Issuance of Licenses.

(a) Purpose. This section establishes the application procedures that an abortion facility must 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. This license expires 12 months after issuance up to January 1, 2005, and 24 months after January 1, 2005.

(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 issued January 1, 2005, through December 31, 2005, will expire in either one or two years, to be determined by the department prior to the time of license renewal. Renewal licenses issued January 1, 2006, or after, will 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 Texas Department of Health (department) will 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 must be accurate and complete and must contain original signatures. The initial license fee must accompany the application.

(C) The following documents must 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 ID 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 must 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 non-profit 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 midlevel providers 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 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) federal or state Medicaid or Medicare 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 federal or state (any state) 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 will not be refunded.

(ii) A facility which has withdrawn its application must reapply for a license in accordance with this section, 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 will be withdrawn upon written request from the applicant.

(6) Issuance of an initial license.

(A) 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 12 months up to January 1, 2005, and 24 months after January 1, 2005. The initial license expires on the last day of the month ending the licensure period.

(C) Pre-inspection. 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 will issue an initial license to the facility.

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

(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 onsite 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 must 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 will 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 will 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

(C) the renewal license fee.

(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 will 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 Texas 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 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 will 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 nonrenewal continues to exist.

(9) Upon revocation or nonrenewal, 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 must 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 must 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 (relating to On-Site Inspections and Complaint Investigations of a Licensed Abortion Facility).

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 January 16, 2004.

TRD-200400346

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Subchapter C. ENFORCEMENT

25 TAC §§139.31 - 139.33

The amendments are adopted under the Health and Safety Code, Chapter 245, Health and Safety Code, Chapter 171, and the Health and Safety Code, §12.001, which provide the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these rules implements Government Code, §2001.039.

§139.31.On-site Inspections and Complaint Investigations of a Licensed Abortion Facility.

(a) General. An on-site inspection shall determine if the requirements of the Act and this chapter are being met.

(1) An authorized representative of the department (surveyor) may enter the premises of a licensed abortion facility at reasonable times during business hours and at other times as it considers necessary to ensure compliance with:

(A) the Act and this chapter;

(B) an order of the commissioner of health (commissioner);

(C) a court order granting injunctive relief; or

(D) other enforcement actions.

(2) The surveyor is entitled to access all books, records, or other documents maintained by or on behalf of the facility to the extent necessary to ensure compliance with the Act, this chapter, an order of the commissioner, a court order granting injunctive relief, or other enforcement action. The department shall maintain the confidentiality of facility records as applicable under federal or state law. Ensuring compliance includes permitting photocopying by a department surveyor or providing photocopies to a department surveyor of any records or other information by or on behalf of the department as necessary to determine or verify compliance with the Act or this chapter.

(3) By applying for or holding a license, the facility consents to entry and inspection of the facility by the department or representative of the department in accordance with the Act and this chapter.

(b) Inspection procedures.

(1) All onsite inspections will be unannounced and conducted, at least, annually.

(2) The department's surveyor shall hold a conference with the person who is in charge of a licensed abortion facility prior to commencing the inspection for the purpose of explaining the nature and scope of the inspection. The surveyor shall hold an exit conference with the person who is in charge of the facility when the inspection is completed, and the surveyor shall identify any records that were duplicated. Any original facility records that are removed from a facility shall be removed only with the consent of the facility.

(3) The department's authorized representative shall hold an exit conference and fully inform the person who is in charge of the facility of the preliminary finding(s) of the inspection and shall give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings. The response shall be made a part of the inspection for all purposes and must be received by the department within 14 calendar days of receipt of the preliminary findings of the inspection by the facility.

(4) After the inspection is completed, the department shall provide the administrator of the facility specific and timely written notice of the findings of the inspection in accordance with paragraph (7) of this subsection.

(5) If the department determines that the facility is in compliance with minimum standards at the time of the on-site inspection, the department will send a license to the facility, if applicable.

(6) If the surveyor finds there are deficiencies, the department shall provide the facility with a statement of the deficiencies; the surveyor's recommendation for further action; or if there are no deficiencies found, a statement indicating this fact.

(7) If the department representative finds there are deficiencies, the facility and the department shall comply with the following procedure.

(A) The department shall provide the facility with a statement of deficiencies onsite at the time of the exit conference or within 14 calendar days of the exit conference.

(B) The facility administrator or person in charge shall sign the written statement of deficiencies and return it to the department with its plan of correction(s) for each deficiency within 14 calendar days of its receipt of the statement of deficiencies. The signature does not indicate the person's agreement with deficiencies stated on the form.

(C) The facility shall have the option to challenge any deficiency cited after receipt of the statement of deficiencies. A challenge to a deficiency(ies) shall be in accordance with this subparagraph.

(i) An initial challenge to a deficiency(ies) shall be submitted in writing no later than 14 calendar days from the facility's receipt of the statement of deficiencies to the program director for abortion facility licensing, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199. The initial written challenge shall include any and all documents supporting the facility's position.

(ii) If the initial challenge is favorable to the department, the facility may request a review of the initial challenge by submitting a written request to the Director, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199. The facility shall submit its written request for review of the initial challenge no later than 14 calendar days of its receipt of the department's response to the initial challenge. The department will not accept or review any documents that were not submitted with the initial challenge. A determination by the Director, Health Facility Licensing and Compliance Division, relating to a challenge to a deficiency(ies) will be considered the final determination by the department.

(iii) The department shall respond to any written challenge submitted under clauses (i) or (ii) of this subparagraph no later than 14 calendar days from its receipt.

(D) The department shall determine if the written plan of correction is acceptable. If the plan of correction(s) is not acceptable to the department, the department shall notify the facility and request that the plan of correction be modified by telephone or resubmitted no later than 14 calendar days from receipt of such request by the facility.

(E) If the facility does not come into compliance by the required date of correction, the department may propose to deny, suspend, place on probation, or revoke the license in accordance with §139.32 of this title (relating to License Denial, Suspension, Probation, or Revocation).

(F) Acceptance of a plan of correction by the department does not preclude the department from taking enforcement action as appropriate under §139.32 of this title.

(8) The department shall refer issues and complaints relating to the conduct or action(s) by licensed health care professionals to their appropriate licensing boards.

(c) Complaints.

(1) In accordance with §139.50 of this title (relating to Disclosure Requirements), all licensed abortion facilities are required to provide the patient and her guardian, if present, if the patient is a minor at time of the initial visit or if guardianship is required, with a written statement that complaints relating to the abortion facility may be registered with the Director, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.

(2) The department will evaluate all complaints against licensed abortion facilities. All complaints submitted to the department must be in writing and signed by the complainant. Only those allegations determined to be relevant to the Act or this chapter will be authorized for investigation. All information pertaining to a complaint is strictly confidential.

(3) The department or its authorized representative may enter the premises of an abortion facility during normal business hours as necessary to assure compliance with the Act and this chapter. The investigation may be conducted on-site, by phone or by mail.

(4) Conduct of the on-site investigation of a licensed abortion facility will include, but not be limited to:

(A) a conference prior to commencing the on-site investigation for the purpose of explaining the nature and scope of the investigation between the department's authorized representative and the administrator of the abortion facility, or his or her designee;

(B) an inspection of the facility;

(C) an inspection of medical records, personnel records, administrative files, reports, other records, and/or working papers;

(D) an interview with any physician or other health care practitioner, including abortion facility personnel who care for the recipient of abortion services;

(E) a conference at the conclusion of the inspection between the department's representative and the administrator or his or her designee of the facility; and

(F) identification by the department's representative of any facility documents that have been reproduced.

(5) If the department finds that there are deficiencies following the on-site inspection, the provisions of subsection (b)(6) and (7) of this section will apply.

(6) The department will review the report of the investigation and determine the validity of the complaint.

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

(a) The department may refuse to issue or renew a license for a facility if the facility fails to comply with any provisions of the Act, or Health and Safety Code, Chapters 245 and 171.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(14) has aided, abetted or permitted the commission of an illegal act;

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

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

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

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

(A) a misdemeanor violation of Health and Safety Code (HSC), Chapter 244;

(B) a misdemeanor or felony involving moral turpitude;

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

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

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

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

(G) a misdemeanor or felony under the TPC:

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

(ii) Title 5 - offenses against the person;

(iii) Title 7 - offenses against property;

(iv) Title 8 - offenses against public administration;

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

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

(vii) Title 11 - offenses involving organized crime.

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

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

(d) All proceedings for the denial, suspension, probation, or revocation of a license under this section will be conducted at the State Office of Administrative Hearings, and in accordance with Chapter 245 of the Texas Health and Safety Code, Chapter 2001 of the Texas Government Code, and the Formal Hearing Procedures of the Texas Department of Health (Texas Administrative Code, Title 25, Part 1).

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

(f) After an inspection in which deficiencies were cited by the surveyor, a facility may submit its license for voluntary cancellation in lieu of the department proceeding with enforcement action. The department may accept such submission or reject it and proceed with an enforcement action. The facility, its owner(s), and its affiliates may not reapply for a license for six months from the date of the surrender or expiration.

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

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

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

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

(h) If the department revokes or does not renew a license, a person may reapply for a license (subject to subsection (d) of this section), by complying with the requirements and procedures in 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 and may consider the enforcement history of the applicant, administrator or clinical director in making such a determination.

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

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

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

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

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

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

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

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

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

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

(p) If a facility has had enforcement action taken by the department against it, the facility, its owner(s), or its affiliate(s) may not apply for a facility license for one year following the effective date of the enforcement action. For purposes of this subsection only, the term "enforcement action" means license revocation, suspension, emergency suspension, or denial or injunctive action but does not include administrative penalties or civil penalties. If 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.

(q) If the department suspends a license, the suspension shall remain in effect until the department determines that the reason for suspension no longer exists. An authorized representative of the department shall conduct an on-site inspection of the facility prior to making a determination.

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

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

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

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

(s) Upon revocation or nonrenewal, a license holder shall return the license to the department.

(t) After an on-site inspection in which deficiencies were cited by the surveyor, a facility may surrender its license before expiration or allow its license to expire in lieu of the department proceeding with enforcement action. A facility may surrender before the expiration date by returning its original license to the department. If a facility surrenders or allows expiration of the license, the facility, its owner(s), and its affiliates may not reapply for a license for six months from the date of the surrender or expiration.

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 January 16, 2004.

TRD-200400347

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


25 TAC §139.34

The repeal is adopted under the Health and Safety Code, Chapter 245, Health and Safety Code, Chapter 171, and the Health and Safety Code, §12.001, which provide the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these 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 January 16, 2004.

TRD-200400348

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Subchapter D. MINIMUM STANDARDS FOR LICENSED ABORTION FACILITIES

25 TAC §§139.41 - 139.60

The amendments are adopted under the Health and Safety Code, Chapter 245, Health and Safety Code, Chapter 171, and the Health and Safety Code, §12.001, which provide the Texas Board of Health (board) with the authority to adopt rules for its procedures and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these rules implements Government Code, §2001.039.

§139.41.Policy Development and Review.

(a) The licensee shall be responsible for the conduct of the licensed abortion facility and shall assume full legal responsibility 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. These written polices shall include at a minimum the following:

(1) administrative policies governing the administration of the facility, covering at a minimum:

(A) personnel;

(B) employee orientation, training, and evaluation;

(C) employee and patient record system;

(D) auditing system for monitoring state or federal funds;

(E) advertisements for the facility;

(F) accuracy of public education information materials and activities in relation to abortion, birth control, and sexually-transmitted diseases;

(G) patient education/information services and referral services;

(H) reporting requirements; and

(I) procedures for the resolution of complaints regarding care or services rendered by licensed health professionals and other members of the facility staff, including contract services or staff. The facility shall document the receipt and the disposition of the complaint. The investigation and documentation must be completed within 30 calendar days after the facility receives the complaint, unless the facility has and documents reasonable cause for a delay.

(2) clinical policies governing medical and clinical practices and procedures of the facility, covering at a minimum:

(A) the provision of medical and clinical services;

(B) the provision of laboratory services;

(C) examination of fetal tissue;

(D) disposition of medical waste;

(E) emergency services;

(F) condition on discharge procedures;

(G) clinical records;

(H) reporting and filing requirements; and

(I) monitoring postprocedure infection(s).

(3) a policy to ensure that the facility is in compliance with fire safety provisions as required by the local codes;

(4) policies on decontamination, disinfection, and sterilization, and storage of sterile supplies;

(5) policies for parental notice for unemancipated pregnant minors as stipulated in Family Code, Chapter 33;

(6) policies for informed consent as stipulated in Health and Safety Code, Chapter 171, the Woman's Right to Know Act;

(7) policies for reporting suspected abuse or neglect as stipulated in Family Code, Chapter 261; and

(8) policies to ensure all women who present to obtain an abortion provide identification that includes the woman's date of birth.

(A) If the woman does not have identification stating her date of birth, she will be required to execute an affidavit on a form published by the department indicating that she does not have appropriate identification and indicating her date of birth on the affidavit.

Figure: 25 TAC §139.41(a)(8)(A)

(B) The facility will keep a copy of the identification presented or the affidavit in its files.

(b) The licensee, in fulfilling its responsibility under subsection (a) of this section, shall review the facility's written policies and procedures periodically, but no less than once every two years; date to indicate time of last review; revise as necessary; and enforce.

§139.43.Personnel Policies.

The licensee shall develop, implement and enforce policies which shall govern all personnel staffed by the facility using the following minimum criteria:

(1) job descriptions, including qualifications for all personnel providing direct or indirect patient care;

(2) a requirement for orientation of all employees, volunteers, students and contractors to the policies and objectives of the facility and participation by all personnel in employee training specific to their job;

(3) job-related training for each position;

(4) a requirement for an annual evaluation of employee performance;

(5) in service and continuing education requirements;

(6) a requirement that all personnel providing direct patient care be currently certified in basic life support by the American Heart Association, the American Red Cross, or the American Safety and Health Institute, or in accordance with their individual professional licensure requirements, and if required in their job description or job responsibilities;

(7) a requirement that all personnel having direct contact with patients (employed or contracting with the facility) sign a statement that they have read, understand, and will respect the rights of all patients as established in §139.51 of this title (relating to Patient Rights at the Facility); and

(8) a requirement that all personnel complete a training program developed jointly by the department and the Department of Protective and Regulatory Services (DPRS) concerning their individual duties to report child abuse, how to identify and recognize abuse, and the jurisdiction of DPRS and local law enforcement over child abuse.

§139.50.Disclosure Requirements.

(a) At the time of a woman's initial consultation with a licensed abortion facility, the facility shall comply with the following.

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

(2) Provide the woman with a written statement identifying the department as the responsible agency for facility complaint investigations. The statement shall inform persons to register complaints with the Director, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756. Complaints must be registered with the department in writing. A complainant must provide his/her name. All complaints shall be confidential.

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

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

(5) Inform the woman of her option to view the department's "A Woman's Right to Know" booklet and resource directory on the world wide web and provide her with the internet address for obtaining the information.

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

(b) The facility shall ensure that the woman has been provided with all information required for voluntary and informed consent, as mandated by HSC, §171.012(a)(1)-(2) at least 24 hours prior to the abortion procedure.

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

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

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

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

§139.51.Patient Rights at the Facility.

A licensed abortion facility shall ensure that all patients:

(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 (HSC), §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, creed, and national origin;

(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, or Exploitation Defined); and

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

§139.52.Patient Education/Information Services.

(a) A licensed abortion facility shall ensure patient education/information services are provided to each patient to:

(1) ensure compliance with Health and Safety Code, §§171.011 and 171.012, concerning informed consent by utilizing the department's certification form, signed by the woman prior to an abortion procedure, and maintained in the patient's clinical record;

Figure: 25 TAC §139.52(a)(1)

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

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

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

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

§139.58.Reporting Requirements.

A licensed abortion facility shall report a woman's death if it results from a complication(s) of an abortion. The report shall be made by phone or fax within one business day after the facility is notified of the death to the director of Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, Telephone (512) 834-6646, or Fax (512) 834-4514 or (512) 834-6709.

§139.59.Anesthesia Services.

(a) Organization of anesthesia services. The organization of anesthesia services shall be appropriate to the scope of the services offered.

(b) General. A licensed abortion facility may provide various levels of sedation/analgesia and/or general anesthesia as defined in subsection (c) of this section. The patient may progress spontaneously from one level to another. The determination of patient monitoring and staffing requirements shall be based on the provisions set out in this section and the patient's acuity and the potential response of the patient to the procedure.

(c) Definitions.

(1) 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.

(2) Moderate sedation/analgesia ("conscious sedation")--A drug-induced depression of consciousness during which patients respond purposefully (reflex withdrawal from a painful stimulus is NOT considered a purposeful response) 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.

(3) 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.

(4) 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.

(d) Minimum staffing for the management of the various levels of sedation/analgesia.

(1) Minimal sedation (anxiolysis). The minimum staffing required for administering minimal sedation (anxiolysis) and local anesthetic shall include the physician and sufficient support staff to perform the procedure.

(2) Moderate sedation/analgesia ("conscious sedation").

(A) The minimum staffing required for administering moderate sedation/analgesia ("conscious sedation") shall always include a minimum of:

(i) a physician, trained and experienced in the use of moderate sedation/analgesia ("conscious sedation"), airway management and resuscitation to manage the care of the patient; and

(ii) one trained, competent clinic staff person to monitor the patient at all times in the procedure and recovery room.

(B) The medical or nursing staff managing the anesthesia care of the patient under moderate sedation/analgesia ("conscious sedation") shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring.

(3) Deep sedation/analgesia.

(A) The minimum staffing during deep sedation/analgesia shall be in accordance with subsection (h) of this section.

(B) The person qualified and performing the administration of deep sedation/analgesia may not be the physician performing the procedure.

(4) General anesthesia.

(A) The minimum staffing during general anesthesia shall be in accordance with subsection (i) of this section.

(B) The person qualified and performing the administration of general anesthesia may not be the physician performing the procedure.

(e) Minimum training and knowledge.

(1) Minimal sedation (anxiolysis). All staff members managing the care of a patient under minimal sedation (anxiolysis) shall be certified in basic life support (BLS) with bi-annual recertification.

(2) Moderate sedation/analgesia ("conscious sedation").

(A) The medical or nursing staff managing the care of a patient receiving moderate sedation/analgesia ("conscious sedation") shall at a minimum have the following:

(i) training in BLS with bi-annual recertification;

(ii) annual training in the recognition of the cardiovascular and respiratory side effects of sedatives, as well as the variability of patient response; and

(iii) current knowledge of emergency supplies and equipment inventory and their use.

(B) The physician, physician extender, or nurse administering the medications shall know the pharmacology of the medications administered.

(3) Deep sedation/analgesia. The minimum training and knowledge required for providing deep sedation shall be in accordance with subsection (h) of this section.

(4) General anesthesia. The minimum training and knowledge required for providing general anesthesia shall be in accordance with subsection (i) of this section.

(f) Clinical and equipment standards for minimal sedation (anxiolysis) and local anesthetic. For licensed facilities administering minimal sedation (anxiolysis) or local anesthetic, the facility must have at a minimum, the following emergency equipment for local anesthetic and/or light sedation management:

(1) oxygen;

(2) mechanical ventilatory assistance equipment that includes airways and manual breathing bag;

(3) the ability to monitor blood pressure;

(4) emergency drugs as specified by the physician(s) on staff; and

(5) functioning oral suction machine apparatus.

(g) Procedure room requirements for moderate sedation/analgesia ("conscious sedation") and deep sedation/analgesia.

(1) Moderate sedation/analgesia ("conscious sedation"). The minimum standards for the procedure room(s) where moderate sedation/analgesia ("conscious sedation") is administered are as follows.

(A) The facility shall have the capability of monitoring blood pressure and oxygen saturation as well as a functioning oral suction machine apparatus.

(B) All patients receiving moderate sedation/analgesia ("conscious sedation") shall have a functional intravenous access in place. A functional intravenous access shall be placed in a patient's vein prior to the procedure and maintained until the patient has recovered from the effects of sedation as determined by the person administering the sedation or the physician performing the procedure.

(C) Emergency supplies and equipment shall be readily accessible and shall include the necessary drugs and equipment to resuscitate a non-breathing and unconscious patient. There shall be documentation that all emergency equipment and drugs are checked and maintained on a scheduled basis.

(D) Pharmacological antagonist medications and staff trained to administer these medications shall be readily available.

(2) Deep sedation/analgesia. The minimum standards for the procedure room where deep sedation/analgesia is administered shall be in accordance with subsection (h) of this section.

(3) General anesthesia. The minimum standards for the procedure room where general anesthesia is administered shall be in accordance with subsection (i) of this section.

(h) Standards for administering deep sedation/analgesia.

(1) A licensed abortion facility which provides deep sedation/analgesia shall provide professional staff; equipment for the administration (of deep sedation/analgesia); a post anesthesia care area; monitoring equipment for procedure room and post anesthesia recovery area sufficient for the provision of deep sedation/analgesia in accordance with the following American Society for Anesthesiologists standards and guidelines:

(A) Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists, dated April 2002;

(B) Standards, Guidelines, and Statements, dated October 2002, specifically:

(i) Basic Anesthetic Monitoring, dated October 21, 1986, as amended October 21, 1998; and

(ii) Standards for Post-Anesthesia Care, dated October 12, 1988, as amended October 19, 1994.

(2) If the provisions contained in the guidelines listed in paragraph (1) of this subsection conflict with this section, the provisions of this section supersede.

(3) Copies of the standards and guidelines are available for review at the Texas Department of Health, Health Facility Licensing and Compliance Division, Exchange Building, 8407 Wall Street, Austin, Texas 78754. Copies may also be obtained by writing the American Society of the Anesthesiologists, 520 North West Highway, Park Ridge, Illinois 60068-2573; Internet www.ASAhq.org; or by telephone at (847) 825-5586.

(i) Standards for administering general anesthesia.

(1) A licensed abortion facility which provides general anesthesia shall provide professional staff; equipment for the administration of general anesthesia; a post anesthesia care area; and monitoring equipment for procedure room and post anesthesia recovery area sufficient for the provision of general anesthesia. General anesthesia shall be provided in accordance with the following American Society for Anesthesiologists standards and guidelines: American Society of Anesthesiologists Standards, Guidelines, and Statements, dated October 2002, specifically:

(A) Guidelines for Office-Based Anesthesia, dated October 13, 1999;

(B) Basic Standards for Pre-anesthesia Care, dated October 14, 1987;

(C) Basic Anesthetic Monitoring, dated October 21, 1986, as amended October 21, 1998;

(D) Standards for Post-Anesthesia Care, dated October 12, 1988, as amended October 19, 1994; and

(E) Guidelines for Ambulatory Anesthesia and Surgery, dated October 11, 1997, as amended October 21, 1998.

(2) If the provisions contained in the guidelines listed in paragraph (1) of this subsection conflict with this section, the provisions of this section supersede.

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 January 16, 2004.

TRD-200400349

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Chapter 146. TRAINING AND REGULATION OF PROMOTORES(AS) OR COMMUNITY HEALTH WORKERS

25 TAC §146.2

The Texas Department of Health (department) adopts an amendment to §146.2, concerning the Promotor(a) or Community Health Worker Training and Certification Advisory Committee. This section is adopted without changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10076), and the section will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department related to the review of applications and the recommendation of qualifying applicants as sponsoring institutions, training instructors, or as promotores(as) or community health workers. The committee also recommends new or amended rules for the approval of the board. The committee was established under the Health and Safety Code, §11.016, which allowed the board to establish advisory committees. The committee is governed by the Government Code, Chapter 2110, concerning state agency advisory committees.

This section amends provisions relating to the operation of the committee. Specifically, the language is revised to improve the ability of the certification program and to expedite the process of reviewing applications for certification of promotores(as) or community health workers.

No public comments were received during the comment period for the rule.

The amendment is adopted under Health and Safety Code, §11.016, which allows the board to establish advisory committees; §48.003, which requires the board to adopt rules which "establish and operate a certification program for persons who act as promotoras or community health workers."; §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner; and Government Code, §2110.005, which requires the department to adopt rules stating the purpose and tasks of its advisory committees.

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 January 16, 2004.

TRD-200400362

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Chapter 159. TERTIARY MEDICAL CARE

25 TAC §159.1

The Texas Department of Health (department) adopts an amendment to §159.1, concerning the reimbursement to tertiary care facilities and Level IV trauma facilities. Section 159.1 is adopted without changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10077), and therefore the section will not be republished.

The rule implements the Health and Safety Code, Chapter 46, §§46.001-46.007, which identify the tertiary care account as a dedicated account in the general revenue fund and delineate the department's responsibilities to allocate these funds to compensate tertiary care facilities and Level IV trauma facilities for the costs of unreimbursed tertiary medical and stabilization services.

Chapter 46 was unchanged by the 78th Legislature; however, no funds were appropriated for reimbursement to facilities under Chapter 46. Therefore, for state fiscal years 2004 and 2005, no applications for reimbursement will be accepted by the department. In addition, the 78th Legislature amended one of the statutory sources of the funds. House Bill 2292 (Chapter 198, 78th Legislature, 2003), §2.34, deleted the mandate that some unclaimed lottery prize money be placed in the tertiary care account.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed the section and has determined that reasons for adopting the section continue to exist; however, a revision was needed in order to reflect changes to program administration and the condition precedent of the appropriation of funds. Although no funds are appropriated this biennium, since the reimbursement law was not changed, the department wants to keep this section in case funds are appropriated in later years.

The amendment expands upon the definition of tertiary medical services. The amendment also clarifies that annual notification by the department to facilities applies only if funds are appropriated for reimbursement and deletes obsolete language in subsection (e) regarding fiscal year 2000.

The department published a Notice of Intention to Review for §159.1 in the Texas Register on October 10, 2003 (28 Tex Reg 8900). No comments were received.

No public comments were received during the comment period for the rules.

The amendment is adopted under the Health and Safety Code, Chapter 46, §46.004, which requires the department to adopt rules to govern the collection of information from facilities on unreimbursed tertiary medical and stabilization services; and the Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health. The review of these 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 January 16, 2004.

TRD-200400335

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 458-7236


Chapter 265. GENERAL SANITATION

Subchapter B. TEXAS YOUTH CAMPS SAFETY AND HEALTH

25 TAC §265.26

The Texas Department of Health (department) adopts new §265.26, concerning the prohibition of nudity at youth camps except in limited situations. Section 265.26 is adopted with changes to the proposed text as published in the August 22, 2003, issue of the Texas Register (28 TexReg 6693), as a result of comments received during the 30 day comment period. Specifically, new §265.26 provides that a youth camp may not allow campers or staffers to be nude except when bathing, showering, changing clothing, or receiving medical attention. The new rule is necessary for the department to carry out its responsibilities under the Texas Youth Camp Safety and Health Act, Health and Safety Code, Chapter 141. The new rule is not due to recent legislation, but is in response to published comments from nudist associations that plan to operate nudist youth camps in Texas during the 2004 camping season.

The following comments were received concerning the proposed new rule. Following each comment is the department's response and any resulting change(s).

Comment: One commenter recommended extending the rule to camp staffers and suggested more direct language for addressing nudity at youth camps.

Response: The department agreed and included the necessary language involving camp staffers.

Comment: One commenter recommended extending the rule to cover nudity when receiving medical attention.

Response: The department agreed and included the necessary language involving medical attention.

The commenters were individuals representing the Camping Association for Mutual Progress and Camp John Marc, a youth camp for children with special medical needs. Both commenters were in favor of the new rule.

The new rule is adopted under the Health and Safety Code, §141.009, which provides the Texas Board of Health (board) with the authority to adopt rules to establish health and safety standards for youth camps; and the Health and Safety Code, §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§265.26.Nudity Prohibited.

A youth camp may not allow campers or staff to be nude, except when bathing, showering, changing clothing or receiving medical care.

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 January 16, 2004.

TRD-200400336

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: August 22, 2003

For further information, please call: (512) 458-7236


Chapter 295. OCCUPATIONAL HEALTH

Subchapter D. OCCUPATIONAL HEALTH RULES AND GUIDELINES

The Texas Department of Health (department) adopts the repeal of §§295.101-295.109, concerning occupational health rules and guidelines, and new §295.101, concerning recommended allowable concentrations of toxic gases that are being made available to the public. The repeal of §§295.101-295.109 and new §295.101 are adopted without changes to the proposed text as published in the August 22, 2003, issue of the Texas Register (28 TexReg 6699), and the sections will not be republished.

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). Section 295.101 has been reviewed and the department has determined that reasons for adopting the section continue to exist in that a rule on this subject is needed; however, §295.101 needed revisions as described in this preamble and is adopted as a new section under an amended subchapter heading. Sections 295.102-295.109 have been reviewed and the department has determined that the reasons for adopting the sections as rules no longer continue to exist.

A notice of intention to review for §§295.101-295.109 was published in the January 5, 2001, issue of the Texas Register (26 TexReg 245) for the state agency review of rules in accordance with Government Code, §2001.039. No comments were received by the department on these sections.

The repeal of existing §295.101 and new §295.101 are adopted in order to clarify the change in purpose of the section, remove obsolete exposure limits for hazardous substances, and provide recommended allowable concentrations of toxic gases. Sections 295.102-295.109 are repealed because the sections were intended by the Legislature to serve only as guidance standards, and publication of such information in rules limits the department's ability to provide the most current recommended occupational health standards using the most cost effective means. Guidance standards and other occupational safety and health information will now be available to the public via the program's website or by contacting the program at the address and telephone number provided in new §295.101(d).

The new title for Subchapter D, "Occupational Health Guidelines," clarifies that sections under this subchapter serve as occupational health guidelines, rather than enforceable occupational standards for places of employment. New §295.101(a) specifies that the information in the section is being provided in order to meet the requirement specified in the Health and Safety Code (HSC), §341.016(c)(1), for the department to provide the public with information on allowable concentrations of toxic gases. This subsection also clarifies that the department's authority to issue occupational standards is limited by the language in the Health and Safety Code, §341.016(c)(2), and the fact that since passage of HSC, §341.016 in 1945, the U.S. Occupational Safety and Health Administration (OSHA) has been given preemptive federal jurisdiction over occupational safety and health matters in Texas industrial establishments, i.e., in the private sector. Therefore, the information provided in the section is being provided as public information, rather than enforceable standards. New §295.101(b) provides information on how the department derived the List of Toxic Gases and Recommended Allowable Concentrations. Section 295.101(b) clarifies that the List of Toxic Gases includes only those gases that meet the OSHA Hazard Communication Standard's (29 Code of Federal Regulations, §1910.1200, Appendix A) definitions of "toxic" or "highly toxic" by inhalation. New §295.101(b) also clarifies that the toxic gases are identified by both chemical name and Chemical Abstract Service (CAS) Number and the Recommended Allowable Concentrations (RAC) for each gas was derived from the OSHA Permissible Exposure Limit for that substance, provided in both parts per million (ppm) and milligrams per cubic meter (mg/M3 ) of air, as appropriate. New §295.101(c) provides the List of Toxic Gases and RACs. New §295.101(d) provides a program mailing address and telephone number in order to ensure public access to the program's information.

No comments were received on the proposal during the comment period.

25 TAC §§295.101 - 295.109

The repeals are adopted under the Health and Safety Code, §341.002, which provides the Texas Board of Health (board) with the authority to adopt necessary rules to administer and enforce Chapter 341; §341.016(c)(1), which requires the department to make available to the state's citizens information concerning allowable concentrations of toxic gases; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. The review of these 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 January 16, 2004.

TRD-200400352

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: August 22, 2003

For further information, please call: (512) 458-7236


25 TAC §295.101

The new section is adopted under the Health and Safety Code, §341.002, which provides the Texas Board of Health (board) with the authority to adopt necessary rules to administer and enforce Chapter 341; §341.016(c)(1), which requires the department to make available to the state's citizens information concerning allowable concentrations of toxic gases; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. The review of the existing rules being repealed and this new rule 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 January 16, 2004.

TRD-200400353

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: August 22, 2003

For further information, please call: (512) 458-7236


Subchapter E. INDUSTRIAL HOMEWORK STANDARDS

25 TAC §§295.121 - 295.126

The Texas Department of Health (department) adopts the repeal of existing §§295.121-295.126, concerning industrial homework standards. Sections 295.121-295.126 are adopted without changes to the proposed text as published in the August 22, 2003, issue of the Texas Register (28 TexReg 6701), and will not be republished.

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 295.121-295.126 have been reviewed, and the department has determined that reasons for adopting the sections no longer continue to exist.

A notice of intention to review for §§295.121-295.126 was published in the January 5, 2001, issue of the Texas Register (26 TexReg 245) for the state agency review of rules in accordance with Government Code, §2001.039. No comments were received due to publication of this notice.

The repeal of §§295.121-295.126 removes unnecessary language and deletes an obsolete reference to a program created in 1937, when industrial homeworkers were commonly used to manufacture articles for employers. The existing rules contained language that is redundant with language in the Health and Safety Code (HSC), Chapter 143, the Industrial Homework Act, and the repeal removes unnecessary rules.

No comments were received on the proposal during the comment period.

The repeals are adopted under the Health and Safety Code (HSC), §143.010, which provides the Texas Board of Health (board) with the authority to adopt necessary rules to administer and enforce Chapter 143; and HSC, §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. The review of these 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 January 16, 2004.

TRD-200400354

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: August 22, 2003

For further information, please call: (512) 458-7236


Chapter 295. OCCUPATIONAL HEALTH

The Texas Department of Health (department) adopts the repeal of existing §§295.141-295.148, concerning standards for face and eye protection in public schools, and new §§295.141-295.143, concerning guidelines for selection and use of face and eye protection in public schools. The repeal of §§295.141-295.148 and new §§295.141-295.143 are adopted without changes to the proposed text as published in the August 22, 2003, issue of the Texas Register (28 TexReg 6702), and the sections will not be republished.

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 295.141-295.148 have been reviewed and the department has determined that reasons for adopting the sections continue to exist in that guidelines on this subject are needed. However, existing §§295.141-295.148 needed extensive revisions, as described in this preamble, and were repealed and replaced by new §§295.141-295.143, which are adopted under an amended subchapter heading.

A notice of intention to review for §§295.141-295.148 was published in the January 5, 2001, issue of the Texas Register (26 TexReg 245) for the state agency review of rules in accordance with Government Code, §2001.039. No comments were received due to publication of this notice.

Existing §§295.141-295.148 were repealed in order to clarify the change in applicability of the sections, remove obsolete standards and guidelines for face and eye protection, remove manufacturing and design standards that are not applicable to the purchasers of face and eye protection equipment, and facilitate adoption by reference of current and amended federal standards as guidelines for selection and use of face and eye protection.

The amended title for Subchapter F, "Guidelines for Selection and Use of Face and Eye Protection in Public Schools," clarifies that the sections under this subchapter are intended to serve as recommended guidelines for performing hazard assessments and making choices regarding the appropriate types of face and eye protection needed for certain activities in public schools, rather than serving as enforceable standards for the design and manufacture of face and eye protective equipment. New §295.141 clarifies that the rules are issued as health protection guidelines for selection and use of face and eye protection in public schools under the Health and Safety Code, §341.002(2), and are applicable to employees, students, and visitors who participate in certain educational activities and programs that pose a high risk for face or eye injuries. New §295.142 adopts by reference, as guidelines only, the standards for selection and use of eye and face personal protective equipment established by the U.S. Occupational Safety and Health Administration (OSHA), and adopts as a guideline, as amended, an OSHA reference document that assists employers in selecting eye and face protection based on workplace hazard assessments. New §295.143 provides a program mailing address and telephone number in order to ensure public access to the referenced documents and other program information.

No comments were received on the proposal during the comment period.

Subchapter F. STANDARDS FOR FACE AND EYE PROTECTION IN PUBLIC SCHOOLS

25 TAC §§295.141 - 295.148

The repeals are adopted under the Health and Safety Code, §341.002(2), which provides the Texas Board of Health (board) with the authority to establish standards and procedures for health protection measures; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. The review of these 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 January 16, 2004.

TRD-200400355

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: August 22, 2003

For further information, please call: (512) 458-7236


Subchapter F. GUIDELINES FOR SELECTION AND USE OF FACE AND EYE PROTECTION IN PUBLIC SCHOOLS

25 TAC §§295.141 - 295.143

The new rules are adopted under the Health and Safety Code, §341.002(2), which provides the Texas Board of Health (board) with the authority to establish standards and procedures for health protection measures; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. The review of these 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 January 16, 2004.

TRD-200400356

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 5, 2004

Proposal publication date: August 22, 2003

For further information, please call: (512) 458-7236


Part 2. TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION

Chapter 415. PROVIDER CLINICAL RESPONSIBILITIES

Subchapter G. DETERMINATION OF MANIFEST DANGEROUSNESS

25 TAC §415.305

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts amendments to §415.305 of Chapter 415, Subchapter G, concerning determination of manifest dangerousness without changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10079).

Revisions to the rules in 2002 resulted in an inadvertent change to a requirement for the TDMHMR Review Board (i.e., a unanimous vote in order to determine a person manifestly dangerous). In the previous version of the rules, a unanimous vote by facility review board members was required in order for a person to be determined manifestly dangerous and a unanimous vote by the TDMHMR Review Board members was required in order for a person to be determined not manifestly dangerous. In an effort to combine the procedures for facility review boards and the TDMHMR Review Board, the type of unanimous vote for facility review boards was also required of the TDMHMR Review Board. The amendment changes the type of unanimous vote for the TDMHMR Review Board to that which was required in the previous version of the rules.

No comment on the proposal was received.

This section is adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority, and the Texas Code of Criminal Procedure, Articles 46.02 and 46.03, which require the TDMHMR commissioner to appoint a review board to determine whether a person committed to the maximum security unit is manifestly dangerous.

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 January 15, 2004.

TRD-200400254

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: February 4, 2004

Proposal publication date: November 14, 2003

For further information, please call: (512) 206-4516


Chapter 417. AGENCY AND FACILITY RESPONSIBILITIES

Subchapter K. ABUSE, NEGLECT, AND EXPLOITATION IN TDMHMR FACILITIES

25 TAC §417.504

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts amendments to §417.504 of Chapter 417, Subchapter K, concerning abuse, neglect, and exploitation in TDMHMR facilities, with changes to the proposed text as published in the October 10, 2003, issue of the Texas Register (28 TexReg 8804).

The amendments redefine the types of allegations accepted for investigation by the Texas Department of Protective and Regulatory Services (TDPRS). TDPRS has adopted similar amendments in the December 19, 2003, issue of the Texas Register to initiate a workload reduction in response to a 25% reduction in funding for investigations in TDMHMR facilities by the 78th Legislature.

The definition of "verbal/emotional abuse" in §417.504(b)(1)(C) has been modified to clarify that the definition is met is the act or communication is of such a serious nature that a reasonable person would consider it harmful or causing distress.

Written comments on the proposal were received from the Parent Association for the Retarded of Texas (PART), Austin; Advocacy Incorporated, Austin; Texas Federation of Families for Children's Mental Health, Austin; and a parent of a state school resident, Garland.

Regarding the definition of "verbal/emotional abuse" in §417.504(b)(1)(C), two commenters were incredulous that if a person served were not capable of showing observable distress at being verbally or emotionally abused, then employees and others could curse, vilify, or degrade him or threaten him with physical or emotional harm. The commenters stated that "this is unbelievable that anyone with any compassion or common sense would think these actions are okay" if persons with mental retardation cannot show their pain. The commenters noted that the majority of persons served in state mental retardation facilities function in the severe range (one-year to three-year-old level) or profound range (under one-year-old level) and asked why anyone would want to give these individuals less protection. TDMHMR responds that it has revised the language in the definition to reflect a change made by TDPRS, who has statutory authority to define abuse. TDPRS has revised its definition in response to a similar comment and, accordingly, TDMHMR has revised related provisions within this rule. TDMHMR assures the commenters that verbal and emotional mistreatment of a person served is strictly prohibited and appropriate disciplinary action will be taken if TDMHMR determines that an employee has verbally or emotionally mistreated a person served. TDMHMR remains committed to providing care that respects the dignity and well being of persons served in its facilities.

Two commenters asked why the example language in §417.504(c) was being deleted. TDMHMR responds that the language was proposed as deleted so TDMHMR rules would not be inconsistent with TDPRS rules. TDPRS proposed two additional examples of general complaints that would not be investigated under its rules and TDMHMR chose not to reiterate all TDPRS's examples in its rules.

One commenter stated that the proposed rule amendment "provides excellent clarification of verbal/emotional abuse, and our organization supports its change." TDMHMR responds that it appreciates the commenter's support.

Another commenter stated that the proposed changes fundamentally alter the definition of verbal/emotional abuse to eliminate language that is pro-active and preventative and could serve as a deterrent to other potential perpetrators. The commenter expressed concern that "observable distress or harm" will be very difficult to operationalize and is a subjective determination. The commenter stated that "if these changes are adopted, we may experience an increase in allegations since the message that will be perceived is that certain types of allegations will not be investigated by PRS and therefore are not as serious." The commenter respectfully encouraged TDMHMR to enter into a dialogue with TDPRS to ensure a process is developed to transfer those allegations to TDMHMR with a certain amount of assurance that TDMHMR will address them, incorporate them into the data collection system and provide feedback to TDPRS on how the issue was addressed. The commenter indicated that her comments were supported by "Federation of Families, Mental Health Association in Texas and Texas Mental Health Consumers." TDMHMR responds that it has revised the language in the definition to reflect a change made by TDPRS, who has statutory authority to define abuse. TDPRS has revised its definition in response to a similar comment and, accordingly, TDMHMR has revised related provisions within this rule. TDMHMR remains committed to providing care that respects the dignity and well being of persons served in its facilities. This will include providing effective leadership to our employees and, when needed, taking appropriate disciplinary action. Regarding the development of a process to transfer to TDMHMR those allegations that won't be investigated by TDPRS, TDMHMR responds that TDPRS will refer those allegations (i.e., complaints) to the head of the facility who, as required by §417.504(c)(4), ensures the complaint is investigated administratively. Regarding assurances that TDMHMR will address the allegations, incorporate them into the data collection system, and provide feedback to TDPRS on how the issue was addressed, TDMHMR responds that the allegations will be investigated administratively as a general complaint as provided in §417.504(c)(4). TDMHMR notes that general complaint investigations are incorporated into facilities' data collection systems, but feedback is not provided to TDPRS.

The rule amendments are adopted under the Texas Health and Safety Code, §532.015(a), which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; the Texas Human Resources Code, Chapter 48, which requires the reporting and investigations of abuse, neglect, and exploitation of elderly and disabled persons; §48.255, which requires TDMHMR and TDPRS to develop joint rules to facilitate investigations in state mental health and mental retardation facilities; the Texas Family Code, Chapter 261, which requires the reporting and investigations of abuse or neglect of a child receiving services in a facility operated by TDMHMR; and §261.404, which requires TDMHMR and the Texas Department of Protective and Regulatory Services (TDPRS) to develop joint rules to facilitate investigations of a child receiving services in a facility operated by TDMHMR.

§417.504.Prohibition and Definitions of Abuse, Neglect, and Exploitation.

(a) Abuse, neglect, and exploitation of any person served is prohibited.

(b) Consistent with Chapter 711 of Title 40 (concerning Investigations in TDMHMR Facilities and Related Programs), the terms "abuse," "neglect," and "exploitation" are defined as follows when the alleged perpetrator is an employee, agent, contractor, or is unknown.

(1) Abuse is:

(A) physical abuse, which is:

(i) an act or failure to act performed knowingly, recklessly, or intentionally, including incitement to act, which caused or may have caused physical injury or death to a person served;

(ii) an act of inappropriate or excessive force or corporal punishment, regardless of whether the act results in a physical injury to a person served; or

(iii) the use of chemical or bodily restraints on a person served not in compliance with federal and state laws and regulations, including:

(I) Chapter 405, Subchapter F of this title (concerning Voluntary and Involuntary Behavioral Interventions in Mental Health Programs); and

(II) Chapter 405, Subchapter H of this title (concerning Behavior Management - Facilities Serving Persons with Mental Retardation);

(B) sexual abuse, which is any sexual activity involving an employee, agent, or contractor and a person served, including but not limited to:

(i) kissing a person served with sexual intent;

(ii) hugging a person served with sexual intent;

(iii) stroking a person served with sexual intent;

(iv) fondling a person served with sexual intent;

(v) engaging in with a person served:

(I) sexual conduct as defined in the Texas Penal Code, §43.01; or

(II) any activity that is obscene as defined in the Texas Penal Code, §43.21;

(vi) requesting, soliciting, or compelling a person served to engage in:

(I) sexual conduct as defined in the Texas Penal Code, §43.01; or

(II) any activity that is obscene as defined in the Texas Penal Code, §43.21;

(vii) in the presence of a person served:

(I) engaging in or displaying any activity that is obscene, as defined in the Texas Penal Code §43.21; or

(II) requesting, soliciting, or compelling another person to engage in any activity that is obscene, as defined in the Texas Penal Code §43.21;

(viii) committing sexual exploitation, as defined in the Texas Civil Practice and Remedies Code, §81.001, against a person served. A copy of the Texas Civil Practice and Remedies Code, §81.001, is referenced as Exhibit A in §417.516 of this title (relating to Exhibits);

(ix) committing sexual assault as defined in the Texas Penal Code §22.011, against a person served;

(x) committing aggravated sexual assault as defined in the Texas Penal Code, §22.021, against a person served; and

(xi) causing, permitting, encouraging, engaging in, or allowing the photographing, filming, videotaping, or depicting of a person served if the employee, agent, or contractor knew or should have known that the resulting photograph, film, videotape, or depiction of the person served is obscene as defined in the Texas Penal Code, §43.21, or is pornographic; and

(C) verbal/emotional abuse, which is any act or use of verbal or other communication, including gestures, to curse, vilify, or degrade a person served or threaten a person served with physical or emotional harm, that results in observable distress or harm to the person served or be of such a serious nature that a reasonable person would consider it harmful or causing distress.

(2) Neglect is a negligent act or omission by any individual responsible for providing services to a person served, which caused or may have caused physical or emotional injury or death to a person served or which placed a person served at risk of physical or emotional injury or death. Neglect includes, but is not limited to, the failure to:

(A) establish or carry out an appropriate individual program plan or treatment plan for a person served if such failure results in a specific incident or allegation involving a person served;

(B) provide adequate nutrition, clothing, or health care to a specific person served; or

(C) provide a safe environment for a specific person served, including the failure to maintain adequate numbers of appropriately trained staff if such failure results in a specific incident or allegation involving a person served.

(3) Exploitation is the illegal or improper act or process of using a person served or the resources of a person served for monetary or personal benefit, profit, or gain.

(c) Abuse, neglect, or exploitation does not include:

(1) the proper use of restraints and seclusion, including PMAB, and the approved application of behavior modification techniques as described in:

(A) Chapter 405, Subchapter F of this title, relating to Voluntary and Involuntary Behavioral Interventions in Mental Health Programs;

(B) Chapter 404, Subchapter E of this title, relating to Rights of Persons Receiving Mental Health Services; and

(C) Chapter 405, Subchapter H of this title, relating to Behavior Management -- Facilities Serving Persons With Mental Retardation;

(2) other actions taken in accordance with TDMHMR rules;

(3) such actions as an employee/agent/ contractor may reasonably believe to be immediately necessary to avoid imminent harm to self, persons served, or other individuals if such actions are limited only to those actions reasonably believed to be necessary under the existing circumstances. Such actions do not include acts of unnecessary force or the inappropriate use of restraints or seclusion, including PMAB; or

(4) general complaints (e.g., regarding rights violations; theft of property; the daily administrative operations of a facility). (Within 24 hours of receipt of such a complaint, the APS investigator refers the complaint to the head of the facility using the Adult Protective Services Referral Form, who ensures the complaint is investigated administratively by the head of the facility, the facility rights officer, or other appropriate parties.)

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 January 15, 2004.

TRD-200400255

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: February 4, 2004

Proposal publication date: October 10, 2003

For further information, please call: (512) 206-4516