The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on January 16, 1998, enters this order finally adopting the repeal of §§137.1 - 137.11, and new §§137.1 - 137.4, 137.11 - 137.13, 137.21 - 137.23, and 137.31 - 137.34, 137.36 - 137.55, concerning licensure and regulation of birthing centers. The new sections are adopted with changes to the proposed text as published in the July 22, 1997, issue of the Texas Register TexReg 6818). Proposed §137.35 is being withdrawn from consideration for adoption; §137.35 is reserved for use at a later time. The repeal of §§137.1 - 137.11 are adopted without changes and will not be republished.

The sections being repealed were adopted October 1986 to implement the Texas Birthing Center Licensing Act (Act) created by the 69th Legislature, 1985. These sections have not been substantially revised since that time. Since the implementation of the current rules, many changes have taken place. The department has experienced increased costs associated with regulating birthing centers and has determined the need for stronger compliance measures. The fees have been increased to make the program self-supporting. The application procedures for obtaining a license and enforcement provisions have been updated to meet the need for stronger compliance measures. The new sections will increase the quality of care for women choosing to give birth to their babies in a birthing center.

The current sections are being repealed and replaced by the new sections with the advice of the Birthing Center Ad Hoc Rules Committee (committee), which includes physicians, certified nurse midwives, documented midwives, and two registered nurses from an area hospital, one member of a local city health department and department staff from the Health Facility Licensing Division, the Health Facility Compliance Division, the Bureau of Vital Statistics, and the Bureau of Clinical and Nutrition Services. The new sections reflect reorganization of the current sections; development of new language to address the areas of concern identified by the committee and department staff; and the deletion of current language to eliminate identified contradictions or unnecessary regulation.

The new sections do not address the issues of work and the practice of the clinicians in the birthing center be they certified nurse midwives, documented midwives, or physicians. The clinicians practicing in the centers are subject to their respective regulatory and licensing boards. Issues about practice and complaints would be referred to the appropriate licensing boards and would not fall within the purview of the birthing center regulations.

Sections 137.1 - 137.11 are being repealed to reorganize the chapter and update current language covering definitions; unregulated centers; exemptions; issuance and renewal of licenses; surveys; conditions of license; license denial, suspension, or revocation; operational and clinical standards; complaints and reporting of incidents; and access to records.

New Subchapter A, §§137.1 - 137.4, covers general provisions. The general provisions include the purpose and scope for these rules; updated and clarified definitions of words and terms used throughout the chapter; a new schedule of fees which increases the license fee from $300 to $1,000 effective March 1, 1998, and the renewal license fee from $300 to $1,000 effective March 1, 1999; and the general provisions for licensure. Obsolete definitions have been removed, new definitions have been added, and other definitions have been clarified to reflect current terminology for the industry. The fee increases have been set by the Board of Health and are necessary to cover increased administrative costs that are incurred by the department to regulate birthing centers. Publication of these rules provide the required notification of fee increase required by Texas Civil Statutes, Article IX, §77. The general provisions for licensure state the minimum provisions for obtaining a birthing center license.

New Subchapter B, §§137.11 - 137.13, establishes new licensing procedures. The new licensing procedures provide: updated license application and renewal procedures; updated requirements regarding change of ownership or services and closure of a birthing center; and the time period for processing a license. There will no longer be a Category A and a Category B license as these rules apply to all birthing centers. The information required to accompany the application has been expanded to provide the department with necessary information to better protect the health and safety of mothers and their newborn infants. Applicants will be required to disclose specific previous criminal convictions and enforcement actions that may affect licensure.

New Subchapter C, §§137.21 - 137.23, establishes new enforcement procedures. The new section update and clarify survey procedures to reflect current practices; procedures for denial, suspension or revocation of a license; and procedures for handling complaints. The updated enforcement procedures provide the department with procedures for ensuring that birthing centers comply with the Act and these rules. Surveys will be performed by the department every three years instead of every year, unless the birthing center has received written deficiencies.

New Subchapter D, §§137.31 - 137.55, establishes new operational and clinical standards for the provision and coordination of treatment and services provided by a birthing center. The standards include: operational and clinical policies and procedures; organizational structure and delegation of authority; personnel policies; qualifications and duties of staff (including supervision of professional and non-professional personnel); student health care professionals; physical, environmental, and infection control standards for birthing centers; disposition of medical waste; general requirements governing the provision and coordination of treatment and services; risk assessments; emergency services; disclosure requirements; prenatal care; serologic test for syphilis and Human Immunodeficiency Virus (HIV) infection; physician delegation; physician consultant procedures; and procedures for drugs and biologicals; labor and birth procedures; procedures for the care of the infant; discharge procedures; postpartum and postnatal care of the mother and infant; quality assurance program; clinical records; reporting and filing requirements; and other state and federal compliance requirements.

The additional physical and environmental requirements for birthing centers include: providing a safe and sanitary environment that is properly constructed; providing a functioning sink and toilet; providing emergency lighting and a written fire and disaster plan; and ensuring that appropriate equipment is available to disinfect and sterilize instruments, equipment and supplies before use in the center. Birthing centers will be required to develop, implement, and enforce written policies governing the provision and coordination of treatment and services. Infection control standards have been established which require a birthing center to adopt, implement and enforce written standards for the prevention and control of nosocomial infections. These policies cover universal (standard) precautions; workplace guidelines; educational course work or training; cleaning and laundry services; decontamination, disinfection, and sterilization; and storage of sterile supplies.

The birthing center will be required to provide the department with its organizational structure which clearly defines its lines of authority. Minimum qualifications and duties have been added for professional and nonprofessional staff. Birthing centers will be required to ensure that its birth attendants comply with accepted standards of practice be they certified nurse midwives, documented midwives, or physicians. A birthing center is required to have a quality assurance program. This program shall cover all health and safety aspects of client care for both mother and infant; and identify and address quality issues and implement corrective action plans. A birthing center will be required to file the birth certificate or ensure that its birth attendants file the birth certificate. If the Board of Health requires data collection relating to birth defects, the birthing center shall make this data available. Other federal and state requirements have been added relating specifically to documented midwives, laboratory and pharmacy services, professional nurse and licensed vocational nurse reporting and peer review, occupational safety and health, physician assistants, prescription medical devices, and trade and consumer practices, with which birthing centers are required to comply.

Since birthing centers are no longer categorized as Category A or B, references to a specific category have been deleted. The requirements for clinical records have been updated to reflect current standards and allow the clinical record to be maintained as an original, a microfilmed copy, an optical disc imaging system, or a certified copy. A birthing center shall ensure that its birth attendants have clients tested for syphilis and HIV infection during pregnancy and within 24 hours of delivery. If a birthing center allows its documented midwives and certified nurse midwives to accept delegation of tasks by a physician, physician delegation provisions have been specified. A birthing center will be required to have procedures for consulting with a physician who shall be available within a recommended 20 minutes but with a required maximum of 30 minutes for emergency care. Provisions have been added to address student midwives and student health care professionals to allow them to obtain their clinical experience in a birthing center.

In addition to the specific changes mentioned, other changes have been made to clarify and strengthen the intent of these sections as a result of public comment.

The department held two public hearings at the following times and places: 10:00 a.m., Monday, August 18, 1997, Texas Department of Health, 1100 West 49th Street, Room K-100 Lecture Hall, Austin, Texas; and at 10:00 a.m., Friday, August 22, 1997, Brownsville City Library, 2600 Central Blvd., Brownsville, Texas. No one attended the public hearing in Austin.

The following is a summary of comments received at the public hearing in Brownsville and during the comment period which ended September 5, 1997.

COMMENT: Concerning the rules in general, a commenter asked "Can the department send staff to provide some kind of courses or training where we can actually be doing some of the procedures, like administering oxygen and doing an episiotomy, so that we can be giving better services to our patients?"

RESPONSE: The department responds that providing training of this type is beyond the scope of what the department can provide; however the department will share the commenter's question with the Texas Midwifery Board.

COMMENT: Concerning the rules in general, several commenters suggested inserting the word "documented" before the word "midwife" throughout the rules whenever there is reference made to the Texas Midwifery Act, because certified nurse-midwives are not regulated by the Texas Midwifery Act, but instead by the Board of Nurse Examiners. Several commenters also suggested that the word "midwife" be changed to "birth attendant" where appropriate.

RESPONSE: The department agrees and has included the word "documented" before the word "midwife" in areas of the rules that relate only to documented midwives. The department has also changed the term "midwife" to "birth attendant" throughout the rules in places where it is the department's intent that the rules apply to all birth attendants. The department added the phrase "comply/conform to accepted standards of practice" throughout the rules where appropriate to state that birth attendants shall only provide services within their respective scope of practice. In §137.40, relating to risk assessments, the following language has been inserted as new subsection (a) and subsequent subsections were relettered "A center shall adopt, implement, and enforce a written risk assessment system that complies with this section, conforms to accepted standards of practice, and has been approved by the center's clinical director." This means, for example, that if a birth attendant's practice allows him or her to accept a client whose condition is other than low risk (by medical waiver), he or she will not be allowed to accept the client while functioning in a birthing center, because a birthing center is licensed to accept only clients with a low-risk pregnancy.

COMMENT: Concerning the rules in general, a commenter asked for clarification regarding what the department's role is regarding complaints about licensed health care professionals.

RESPONSE: The department agrees that clarification is needed and has added the following language in paragraph (9) of §137.21(d) "The department shall refer issues and complaints relating to the conduct or action by licensed health care professionals to their appropriate licensing boards" and in clause (viii) of §137.34(a)(1)(B) "ensure that issues and complaints relating to the conduct or actions by licensed health care professional(s) are referred and reported to the appropriate licensing board, and that such review and action taken is documented."

COMMENT: Concerning §137.2 relating to definitions, §137.40(b)(1) relating to risk assessments, and §137.46(b) relating to physician consultant procedures, a commenter asked for clarification for the definitions of "physician" and "physician consultant" when used in the language in proposed §137.40(b)(1) (adopted (c)(1)) and §137.46(b). The commenter was not clear as to whether or not the physician consultant had to be a Texas licensed physician.

RESPONSE: The department agrees that the definitions and language need clarification to reflect the department's requirement that the physician consultant be a Texas licensed physician. In §137.46(b), the department replaced the word "should" with the word "shall" to say "...shall be a Texas licensed physician ..." to be consistent with the definition of "physician." The definition of "physician consultant" has been clarified to read "A physician who is currently licensed under the Medical Practice Act, Texas Civil Statutes, Article 4495b, to practice medicine and who consults with the center."

COMMENT: Concerning §137.2 relating to definitions, several commenters suggested striking the definition of "midwife" because the terms "documented midwife" and "certified nurse-midwife" are already defined.

RESPONSE: The department understands the commenters concern, but believes that the commenters concern has been clarified by changing the term "midwife" to "birth attendant" where applicable. However, the term "birth attendant" includes a physician, so in areas of the rules that relate only to certified nurse midwives and documented nurse midwives the term "midwife" is used, therefore the definition of "midwife" still applies.

COMMENT: Concerning §137.3 relating to fees, a commenter stated "I feel the $1,000 fee is too high, because I perform only a few deliveries every year as do a lot of my friends who are midwives and own birthing centers. We want the department to consider a sliding fee scale for midwives based upon the number of deliveries per year and adjust the fee according." The commenter questioned if it would be possible for her to appeal the fee? In addition, two written comments were received expressing similar concerns.

RESPONSE: The department understands the commenter's concern, however the department's costs associated with regulating a birthing center are the same regardless of the number of births performed by a center. The fees have not increased since 1986 when the rules were first adopted, and the department's costs associated with regulating birthing centers have increased substantially since 1986. The Texas Birthing Center Licensing Act, Health and Safety Code, Chapter 244, provides the Board of Health (board) with the authority to establish fees to make the licensing program self-supporting. There are no provisions for appealing fees adopted by the board. The department made no changes as a result of the comment.

COMMENT: Concerning §137.11(b)(4)(N), the commenter stated that centers should not be required to have fax machines.

RESPONSE: The department agrees that a fax machine should not be required and has added the words "if available" after the words "fax number."

COMMENT: Concerning §137.21(d), a commenter stated that the language was too prescriptive and provided alternate language for the survey process.

RESPONSE: The department agrees that the requirements are too prescriptive for birthing centers. The department has revised the language in subsection (d) as suggested to more accurately reflect the survey process for birthing centers.

COMMENT: Concerning the §137.21(d), a commenter was concerned that there was no provision for revisits to facilities when deficiencies are cited during a survey.

RESPONSE: The department refers the commenter to §137.21(a), which states that the department may conduct a survey at other times as it considers necessary to ensure compliance with the Act and the rules adopted under the Act. No change was made as a result of the comment.

COMMENT: Concerning proposed §137.21(d)(4), a commenter was concerned that there was no provision for a surveyor to mail a statement of deficiencies to the facility instead of providing the statement onsite.

RESPONSE: The department agrees that a provision for mailing the statement of deficiencies should be included in the rules and has added language in §137.21(d)(8)(a) to allow a statement of deficiencies to be mailed or faxed to the center within 10 days after the exit conference.

COMMENT: Concerning proposed §137.21(d)(6), a commenter stated that there was no time limit set for a center to correct a deficiency.

RESPONSE: The department responded that the time limit to correct a deficiency is at the discretion of the department. However, as stated in §137.21(d)(8)(D), a center must correct a deficiency within the time documented on the plan of correction form or within 60 days of the date of expiration of the license whichever comes first.

COMMENT: Concerning §137.34(a)(1)(A), several commenters stated that the qualifications of the administrator were too strict and could prevent some birth attendants from meeting the stated standard.

RESPONSE: The department agrees that the qualifications for the administrator need to be clarified to allow birth attendants to qualify as a center's administrator and has added language to clarify that a birth attendant may be an administrator of a center. The department also added language to §137.34(a), which allows one person to act in the capacity of the administrator, the clinical director, and the birth attendant provided that person meets all the qualifications and is capable of performing all of the duties specifically stated for each position. In addition, in §137.34(a)(1)(A)(i), the qualifications for the administrator have been modified to require that if the administrator does not meet the qualifications of a birth attendant, the administrator must have six months training or experience in business administration or have at least six months full-time supervisory or administrative experience in a health care or a health related facility.

COMMENT: Concerning §134.34(a)(1)(A)(i) and (ii), a commenter considered the language unfair, if not illegal, relating to limiting the qualification for the administrator of a center to a person who has not been employed in the last year as an administrator with another center or health related facility at the time the center or facility was cited for violations of a licensing law or rule which resulted in enforcement action taken against the center or health related facility. The commenter asked "What if the violation was secondary to a certified nurse midwife or documented midwife who wasn't following the protocols set by the administrator?"

RESPONSE: The department understands the commenter's concerns and agrees that clarification is needed and has added the following language in §137.34(a)(1)(A)(ii) to clarify the term "enforcement action": "For purposes of this clause only, the term "enforcement action" means license revocation, suspension, emergency suspension, or denial of a license or injunction action but does not include administrative or civil penalties. If the department prevails in one enforcement action (e.g. injunctive action) against the center 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 action (e.g., the center prevails), the prohibition in this clause does not apply."

COMMENT: Concerning §137.34, a commenter suggested that the entire section be deleted because the administrator, clinical director and other staff members are defined in the definitions.

RESPONSE: The department disagrees, as §137.34 contains the qualifications and duties of staff which the department is legislatively mandated to do by the Act. A definition section does not and may not contain required regulatory language.

COMMENT: Concerning §137.34(a)(1), (2) and (3), a commenter stated that if the administrator, clinical director, or the owner is a documented midwife, the rules as written could be interpreted to mean that a documented midwife would be allowed to supervise a certified nurse midwife or a physician.

RESPONSE: The department agrees that the language needs clarification. Language has been added in §137.34(a) to address that in the event the center's birth attendants include a documented midwife, a certified nurse midwife, or a physician, the certified nurse midwife or the physician shall be the clinical director.

COMMENT: Concerning §137.35, financial solvency, a commenter thought the section was extremely restrictive and that any birth center that is not paying employees will not be able to retain these employees and would be subject to penalty under other laws. The commenter suggested that the section be deleted in its entirety.

RESPONSE: The department agrees and has withdrawn the section; however the language "A center shall have the financial ability to carry out its functions under the Act and this chapter." has been retained and moved to §137.4(j) relating to general provisions for licensure.

COMMENT: Concerning §137.37, a commenter requested that the rules relating to infection control practices be expanded to clarify standards relating to universal precautions, sterilization practices, and training or education. The commenter indicated that the rules as proposed were very vague and left interpretation of infection control practices wide open.

RESPONSE: The department agrees and has revised the proposed language and added new language regarding infection control standards to more appropriately describe what is expected of a birthing center.

COMMENT: Concerning §137.39, a commenter asked if student midwives and student health care professionals would be allowed to obtain clinical experience at a birthing center.

RESPONSE: The department agrees that student midwives and student health care professionals should be able to gain clinical experience in a birthing center and has added language as new subsections (g) and (h) in §137.39 which sets out the criteria for student midwives and student health care professionals working in a center.

COMMENT: Concerning §137.40, a commenter asked if the risk assessment involves some assessments that the nurses will think is only in their purview.

RESPONSE: The department understands the commenters concern, however the performance of risk assessment is determined by each birthing center with concurrence the minimum requirements set out in the rules.

COMMENT: Concerning §137.41, a commenter asked if a center is required to have written policies and procedures in place to cover the provision of emergency services.

RESPONSE: The department responds that a facility must adopt, implement, and enforce written policies to provide emergency services. These policies shall include the use of emergency equipment and emergency medications. The department has added clarifying language.

COMMENT: Concerning §137.41, emergency medications and equipment, a commenter asked if documented midwives will be allowed to do more than they should be doing.

RESPONSE: The department disagrees that the language is unclear and has not made any changes as a result of the comment. Documented midwives are expected to follow the rules adopted by the Texas Midwifery Board. Section 137.41 does not conflict with those rules.

COMMENT: Concerning §137.43, relating to prenatal care, a commenter wanted the word "documented" added before the word "midwives" because the language sites the Texas Midwifery Act.

RESPONSE: The department understands the commenters concern; however the intent was to require birthing centers to ensure that its birth attendants comply with accepted standards of practice with regard to prenatal care if provided. The department has clarified the language to reflect this intent. The department has also changed language all throughout the rules where the proposed language pertained specifically to documented midwives to state that birth attendants shall provide services within their respective scope of practice and within the limitations of these rules.

COMMENT: Concerning §137.48(d), a commenter requested that the term "adult" be defined.

RESPONSE: The department disagrees that the term "adult" needs to be defined as this is defined by other state law.

COMMENT: Concerning §137.48(e), a commenter wanted the language changed to "A birth attendant shall be available within ten minutes whenever a client is in the center."

RESPONSE: The department disagrees, because the suggested language is too restrictive. No changes were made as a result of the comment.

COMMENT: Concerning §137.51, several commenters stated that in many birth centers run by physicians and nurse-midwives the mothers and babies receive well-woman and well-baby care for longer than the six-week restriction stated in the rules, and requested that the restriction be removed.

RESPONSE: The department agrees and has removed the six-week restriction as this restriction applies only to the practice of documented midwives. The department has added language to clarify that follow-up care shall be in accordance with accepted standards of practice.

COMMENT: Concerning §137.52, relating to quality assurance, a commenter requested clarification of the intent of this section.

RESPONSE: The department agrees and has expanded this section to include a mechanism to address quality issues and corrective action plans as necessary.

COMMENT: Concerning §137.54, a commenter asked if the reporting requirements included a stillborn.

RESPONSE: The department responded that the rules do include reporting a stillborn and has added clarifying language.

COMMENT: Concerning §137.55, several comments were received requesting clarification of the requirement that birthing centers comply with various practice laws.

RESPONSE: The department agrees that clarification is needed and has changed the language throughout §137.55 to state a center utilizing the services of certain licensed professionals shall ensure that these persons comply with their respective licensing law while functioning in his or her capacity at or for the center. Other language has been clarified to state that if the center provides pharmacy services it shall comply with the Texas Pharmacy Act.

COMMENT: Concerning proposed §137.55(h) (now §137.55(f)), which requires a birthing center ensure that its physicians comply with the Medical Practice Act, Texas Civil Statutes, Article 4495b, a commenter asked if there was a way to refer a patient to a physician in Mexico for a urinary infection or any kind of infection, because financially it is less expensive in Mexico, most of her patients can't afford Texas physicians. The commenter asked if the rules allow midwives to accept documentation from physicians in foreign countries such as Mexico and requested that the issue be addressed in the rules.

RESPONSE: The department responded that §137.55(h) does not address patient referrals; it requires birthing centers in which physicians provide service to be sure that these physicians are licensed under the Medical Practice Act, Texas Civil Statutes, Article 4495b. The department has clarified language in §137.40, to require a birthing center to refer or transfer a woman to a hospital or physician consultant at any time a client's condition deviates from a low-risk pregnancy. The definition of "physician consultant" is "a physician who is currently licensed under the Medical Practice Act, Texas Civil Statutes, Article 4495-1, to practice medicine"; this means that a birthing center must refer a client who has an infection to a Texas licensed physician. However, this does not limit a women's right to choose whether or not to go to that physician or to see a physician in Mexico for treatment of her infection. If the woman's risk condition is upgraded to low risk, she may be readmitted to the birthing center for services. The birthing center may accept documentation of services from a physician licensed to practice medicine in another state or foreign country such as Mexico, provided the documentation is reviewed by a licensed health care professional within their scope of practice. The State of Texas does not have the authority to monitor the quality of services provided by physicians in Mexico or any other foreign countries. For this reason the department requires referral to a Texas licensed physician. The department's goal is to promote quality health care for women and to ensure that a woman receives the best possible quality of care for herself and her child when choosing to deliver in a Texas licensed birthing center.

COMMENT: Concerning §137.55, relating to birthing center physicians and laboratory services, several commenters asked the following questions: (1) "Are test results from a physician in Mexico acceptable for documentation since physicians in Mexico are not required to comply with the Medical Practice Act, Texas Civil Statutes, Article 4495b or the Clinical Laboratory Improvement Amendments of 1988, 42 United States Code, §263a (CLIA)?" (2) "Are specimens that are drawn by the midwives in their birthing centers, using certain types of laboratory procedures (cord blood, syphilis tests, etc.), regulated by the Federal requirements under Clinical Laboratory Improvement Act (CLIA), or can these laboratory procedures be exempt from CLIA regulation?" (3) "Can the rules state whether or not a birthing center has to comply with CLIA requirements if they draw these types of specimens?"

RESPONSE: The department will continue to allow birthing centers to accept documentation from foreign countries, such as Mexico, with acceptance and concurrence of such documentation by a licensed health care professional within their scope of practice. The department has added language to clarify this intent as new subsection (f) in §137.39 as follows: "A center that provides care or services to a client based upon laboratory, radiological or ultrasonography reports or medical records from another state or country, shall have these reports and records reviewed by a licensed health care professional within his or her scope of practice. The clinical record shall contain evidence of the licensed health care professional's review of these reports and records and of any recommendations." In addition, to further clarify this intent, language was added in §137.55(c) as follows: " If a center accepts laboratory test results from another state or foreign country, such as Mexico, the laboratory documents must be reviewed and approved by a licensed health care professional within his or her scope of practice." A birthing center which allows its birth attendants to draw blood for testing is required to comply with CLIA regulations as stated in §137.55(c). There are no waivers or exemptions for the procedures described by the commenter.

COMMENT: Concerning §137.55(c), which states the requirement for laboratory results to be CLIA approved, a commenter stated that currently department surveyors honor lab results from Mexico on clients of birthing centers, and further questioned if this practice will be discontinued when the new rules are adopted?

RESPONSE: As previously stated, it is the department's main objective to ensure that birthing centers provide their clients with the best possible quality of care. The rules have been strengthened to provide the department with the means to regulate the quality of care provided by Texas licensed birthing centers. Language has been added to allow centers to accept laboratory test results from another state or foreign country such as Mexico, provided the laboratory documents have been reviewed and approved by a licensed health care professional within their scope of practice.

Department staff made the following changes.

In §137.2, the department made changes to proposed definitions of the following words and terms: affiliate, birth attendant, birthing center and center, health care facility, hospital, low-risk, nosocomial infection, minimally qualified person, physician assistant, physician consultant, and referral hospital. Most of the changes made to the proposed definitions were for clarification purposes. Changes other than for clarification purposes include the following changes. The definition of "affiliate" reduced the percentage of direct ownership for a corporation to be at least 5% instead of 10%. The definition for "health care facility" was changed to include the language "or home and community support services agency." The definition of "hospital" was clarified to include the following language "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 sq.)." The definition for "low-risk" was modified to include the word "pregnancy" and the definition for "normal uncomplicated pregnancy" was deleted because the term was changed to "low-risk pregnancy" throughout the rules. The definition for "physician consultant" was clarified to require the physician consultant to be a physician who is currently licensed under the Medical Practice Act.

In §137.2, the department added several new definitions to provide clarification for new language added in the final rules as a result of public comment. New definitions are included for the following words: critical item, decontamination, disinfection, licensed health care professional, non-critical items, plan of correction, quality, quality assurance, quality improvement, semi-critical items, standards, sterile field, and sterilization.

In §137.3(a)(1)(A), concerning the initial licensing fee, the effective date of the fee increase was changed from "January 1, 1998" to "March 1, 1998" for applicants for an initial license. In §137.3(a)(2), concerning annual renewal license, the effective date of the fee increase for renewal of a license was changed from "January 1, 1999 to March 1, 1999." Also in §137.3(a)(1)(A) the words "a center operating" was changed to "an application submitted" to clarify the intended meaning.

In §137.4(d), concerning general provisions for licensure, the words "in labor" replaced the words "or initiate services" to clarify that a center may not admit a client who is in labor until it has received an initial license.

In §137.11(b)(4)(K), the names and addresses of minimally qualified persons are required to be submitted with the application for licensure.

In §137.11(f)(1), the sentence "The administrator or birth attendant shall attend the presurvey conference" was deleted because it was too prescriptive. The center is responsible for determining who is best qualified to attend the presurvey conference.

In §137.11(f)(2)(B)(i), subclause (II) was deleted because it was not applicable to birthing centers.

In §137.11(f)(3), concerning the effective period of an initial license, language was added to clarify the expiration date of an initial license.

In §137.11(g)(2) and (g)(3)(C), concerning procedures for renewing a license, the requirement that a self-survey report be completed as part of the renewal process was determined to be unnecessary because a center is now required to have an on-going quality assurance process which includes a self evaluation process.

In §137.11(g)(5) (proposed as §137.11(g)(6)), the date an annual license expires was included to provide clarification.

In §137.11 (i)(6), concerning general requirements for renewal of an annual license, language was added to require a licensee, who decides not to renew its license, to cease providing services and return the original license certificate to the department.

In§137.21(b)(3), the sentence "If the administrator or his or her designee is not present at the surveyor's arrival, the survey will not be conducted" was deleted. It was determined that because of the travel costs involved, a department representative should be able to conduct the on-site survey instead of having to reschedule at an additional cost to the department. In accordance with this section of the rules, the center is required to have an administrative designee available in the absence of the administrator. The department representative will cooperate with the center's staff in ensuring that the administrator is informed of its presence for the on-site visit.

In §137.21(d), concerning survey procedures, language was extensively clarified to reflect current survey practices.

In §137.22(a)(5)(B), concerning license denial, suspension, or revocation, several offenses (misdemeanors and felonies) were added which may effect licensure, because the department determined that these offenses directly relate to the ability of the licensee to operate a center.

In §137.22(b), concerning notification of proposed denial, suspension, or revocation of a license, procedures were added for when a notice is returned or undeliverable. If a notice is returned or undeliverable, the department may publish a notice in the newspaper.

In §137.22(e), concerning the effective time of a suspension, the following language was added as paragraph (3) in the final rules "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."

In §137.23(e), concerning notification of a complaint investigation, the department added language to state that the department is not required to give notification prior to the investigation.

In §137.34(a)(1)(B), language was added to the duties of the administrator requiring the administrator to ensure all billings or insurance claims (e.g. Medicaid) submitted are accurate as follows: "(vii) implement an effective budgeting and accounting system which must include an auditing system for monitoring state or federal funds. The administrator shall ensure all billings or insurance claims (e.g. Medicaid) submitted are accurate." to address the requirement for an auditing system for monitoring state or federal funds.

In §137.34(a)(1)(B), the following language was added as clauses (viii) and (ix) to require the administrator to "ensure that issues and complaints relating to the conduct or actions by licensed health care professional(s) are referred and reported to the appropriate licensing board, and that such review and action taken is documented; and administratively conduct or supervise the resolution(s) of compliant(s) received from clients in the delivery of their care or services received at the center."

In §137.38(1), concerning disposal of placentas and all biomedical waste, the language was changed to require compliance with department rules at 25 TAC, §§1.131 - 1.137 relating to disposal of special waste.

In §137.38(3), concerning the release of the placenta to the family at the time of discharge, language was added to clarify that release of the placenta included release to the client.

In §137.39, concerning general requirements for the provision and coordination of treatment and services, language was added as new subsection (e) which requires a center to ensure that its licensed health care professional practice within the scope of their practice and within the constraints of applicable state laws and regulations governing their practice, and that they must follow the facility's written policies and procedures.

In §137.40, concerning risk assessments, the language was modified to clarify that the risk assessment system must be written in compliance with this section, conform to accepted standards of practice, and be approved by the center's clinical director; and that the system must be applied to clients prior to admission and throughout the pregnancy for continuation of services and during the postpartum period. The language relating to referral and transfer of a client when her condition deviates from a low-risk pregnancy has been clarified. Language has been added to require that the transfer or referral of a client be documented in the clinical record.

In §137.52(a), language was added to require a center to adopt, implement, and enforce a written quality assurance (QA) program. Language was added to require a center's quality assurance program to address issues of unprofessional conduct by any member of the center's staff and/or staff by contract; the integrity of surgical instruments, medical equipment, and patient supplies; the services performed in the facility as they relate to appropriateness of diagnosis and treatment; and medication therapy practices. Language was added to require the center to identify and address any quality issues and implement corrective action plans as necessary, and to require the center to take and document remedial action to address deficiencies found through activities of the QA program.

In §137.53, language was added to clarify that "At the time of an on-site survey, all clinical records must be readily retrievable for review within two hours of the request." Also language was added to state that the clinical record must contain documentation that a birth certificate was filed, or if applicable, a death certificate was filed.

In §137.54, language was added to require an administrator or birth attendant to file a death certificate in the event of the death of a client, an infant, or a stillbirth.

The department made several other changes for the purpose of clarification.

The following associations or entities provided comments on the rules: Materidad Cristo Rey, Mission, Texas; Santa Maria Birth Center, Brownsville, Texas; Holy Family Birth Services, Weslaco, Texas; The Birth Center at Copperas Cove, Copperas Cove, Texas; the legislative liaison for the Consortium of Texas Certified Nurse-Midwives, Austin, Texas; and several individuals. The commenters were generally in favor of the rules; however, they expressed concerns and asked questions as described in the summary of comments.