The Texas Department of Health (department) proposes the repeal of §§91.1 - 91.7 and proposes new §§91.1 - 91.14, concerning reporting of cancer and other precancerous or tumorous disease incidence data to the department or its authorized representatives. The new sections specify who is required to report; what cancer information is to be reported; when, how and where this information should be reported; a cost-recovery method to access cancer information from facilities failing to report in the prescribed format; a definition of reporting non-compliance; quality assurance activities; immunity from liability for reporters; confidentiality and disclosure of cancer information; and requests for and release of statistical and personal cancer data.

The Cancer Registry Division has been awarded a grant by the United States Department of Health and Human Services, Centers for Disease Control and Prevention (DHHS/CDC) to provide for the support of a statewide population-based cancer registry that meets CDC standards for completeness, timeliness, and quality cancer registry data. The repeal and new sections are needed to implement Health and Safety Code, Chapter 82 (the Cancer Incidence Reporting Act) and to meet requirements of this cancer registry related federally funded grant.

Nancy S. Weiss, Ph.D., Director, Cancer Registry Division has determined that for the first five-year period the sections are in effect, there will be fiscal implications as a result of enforcing or administering the sections as proposed. The effect on state government will be an estimated increase in revenue to the state of approximately $210,000 per year as a result of the proposed cost-recovery data collection. In addition, these sections are necessary to continue to receive $1.1 million per year in federal grant funds. It is estimated that costs to the state to administer the new data collection method will equal the revenues received. There will be no fiscal implications for most local governments. Local governments which are providing cancer diagnosis and/or treatment will incur costs of approximately $7.00 per case (average of 30 minutes per case reported).

Dr. Weiss has also determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing the sections will be to have complete and accurate cancer data reported within six months of initial diagnosis or admission for the diagnosis or treatment of cancer. This will increase the availability of timely, statewide cancer incidence data for use in cancer prevention and control efforts in the State. The anticipated effect on small businesses (as well as large businesses) who do not report will be the cost of data collection by the department estimated to be $30 per unreported cancer case. The economic costs to persons who are required to comply with the sections as proposed will be the staff time to complete reporting requirements which is approximately 30 minutes per case (estimated $7.00 per case). There will be no impact on local employment.

Comments on the proposal may be submitted to Nancy S. Weiss, Ph.D., Director, Cancer Registry Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, (512) 467-2239. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

Cancer Registry

The Texas Department of Health (department) proposes the repeal of §§139.1 - 139.14, and proposes new §§139.1 - 139.8, 139.21 - 139.25, 139.31 - 139.34, and 139.41 - 139.60, concerning reporting and licensing of abortion facilities.

Sections 139.1 - 139.14 are being proposed for repeal to reorganize the chapter and to adopt language to implement recent legislation and to address areas of concern identified by Texas Department of Health staff. The department initially adopted the sections on May 15, 1986, to implement the Texas Abortion Facility Reporting and Licensing Act (Act), Health and Safety Code, Chapter 245, created by the 69th Texas Legislature, 1985. Since the initial adoption, the department has adopted amendments and added new sections to establish standards for facilities administering general anesthesia, to adopt a system for reporting post-abortion complications, and to establish procedures for renewal of a license if a licensee is on active duty with the armed forces of the United States of America serving outside the State of Texas when it is time to renew an abortion facility license. Since the implementation of the existing rules, the department has experienced increased costs associated with regulating abortion facilities and has determined the need for stronger compliance measures. The legislature passed several amendments to the Act during the 75th Legislature, 1997. House Bill 2856 amended Health and Safety Code, Chapter 245, by requiring the department to perform annual renewal inspections prior to the issuance of a renewal license; by requiring an abortion facility to include the facility's license number in its abortion advertisements; and by requiring the department to provide a toll-free information line to provide specific information relating to an abortion facility's performance. Senate Bill 407 also amended Health and Safety Code, Chapter 245, by providing the department with the authority to establish quality assurance measures for an abortion facility to evaluate its medical treatment and medical services and the coordination of these services provided at the facility; minimum standards relating to the management, ownership, and control of the facility; provisions for the release of confidential information to appropriate licensing boards to enforce state licensing laws; enforcement provisions to allow the department to immediately suspend or revoke a license when the health and safety of persons are threatened; and provisions for assessing an administrative penalty(ies) against a person who violates the Act or rules adopted under the Act and providing for an administrative review process. The department has increased licensing fees to make the program self-supporting, strengthened the application process and the enforcement provisions, and addressed the legislative amendments in the new sections.

New §§139.1 - 139.8 establish the general provisions for abortion facilities. Specifically, the sections include the purpose and scope of the chapter; updated and clarified definitions for words and terms used throughout the rules; requirements for abortion facilities operating without a license; qualifications for exemption from licensing requirements; annual reporting requirements for licensed and unlicensed abortion facilities; requirements for providing public information; requirements for abortion facility advertising; and requirements for ensuring quality assurance.

Obsolete definitions have been removed, new definitions have been added, and other definitions have been clarified to reflect current terminology used by the industry. Annual reporting requirements have been amended to allow electronic reporting and reporting on a monthly or quarterly basis.

New §139.6 implements House Bill 2856 which requires abortion facilities to provide a woman, at the time the woman initially consults the facility, a written statement indicating the number of a toll-free telephone line maintained by the department. The department is required to provide the status of the license of any abortion facility; the date of the abortion facility's last inspection of the facility; any violation discovered during the last 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; any corrective action that is acceptable to the department and that is being undertaken by the facility with respect to the violation; 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.

New §139.7 also implements House Bill 2856 to require abortion facilities to include their license number in "any abortion advertisement directly relating to the provision of abortion services at the facility." An "abortion advertisement" means any communication that advertises the availability of abortion services at an abortion facility and that is disseminated through a public medium, including an advertisement in a newspaper or other publication (e.g., telephone book yellow pages), or television, radio, or any other electronic medium; and any commercial use of the name of the facility as a provider of abortion services, including the use of the name in a directory, listing, or pamphlet.

New §139.8 implements Senate Bill 407 which requires the department to set minimum quality assurance standards for abortion facilities. An abortion facility will be required to have a quality assurance committee to evaluate all organized services related to patient care, including services furnished by contract; to ensure that there is a review of any abortion procedure complication(s) and make use of the findings in the development and revision of facility policies; to address issues of unprofessional conduct by any member of the facility's staff (including contract staff); to address infection control practices; to address medication therapy practices; to address the integrity of surgical instruments, medical equipment, and patient supplies; and to address services performed in the facility as they relate to appropriateness of diagnosis and treatment. The QA committee shall be responsible for identifying and addressing quality issues, and implementing corrective action plans as necessary.

New §§139.21 - 139.25 establishes the licensing procedures for abortion facilities. Specifically, the sections cover the general provisions for licensure, licensing fees, application procedures and issuance of licenses, change of ownership or services and closure of an abortion facility, and time periods for processing and issuing a license. The general provisions for licensure state the minimum provisions for obtaining a birthing center license. The licensing fees have been increased to make the program self-supporting. The licensing fees will be increased from $1000 annually to $2,500 annually. The application procedures include the procedures for applying for an initial license, a first annual license, and a renewal license. First time applicants and change of ownership applicants will be required to submit a fee of $1,000 and submit an application for an initial license which upon approval by the department will be effective for the 120 days. Within 45 days of receipt of the initial license, an applicant must submit an application and fee of $1,500 for the first annual license. This license will expire one year from the date of issuance of the initial license. The application fee for renewal of a license will be $2,500 annually. The Board of Health has the authority to set fee to cover administrative costs that are incurred by the department to regulate licensed abortion facilities. Publication of these rules provide the required notification of fee increase required by Texas Civil Statutes, Article IX, §77.

The application procedures for obtaining a license have been updated to meet the need for stronger compliance measures. For example, additional information applicants for a license will be required to disclose concerning the applicant, the applicant's affiliates, and the managers of the applicant, are any proposed or final actions relating to the denial, suspension, or revocation of an abortion facility license in any state, a license for any health care facility in any state, or a home and community support services agency in any state; court civil or criminal action; surrendering a license before expiration of a license or allowing a license to expire in lieu of the department proceeding with enforcement action; federal or state (any state) felony arrests or convictions; federal or state Medicaid or Medicare sanctions or penalties relating to the operation of a health care facility or agency; operation of a health care facility or agency that has been decertified or terminated from participation in any state under Medicare or Medicaid; debarment, exclusion, or contract cancellation in any state from Medicare or Medicaid; federal or state (any state) criminal misdemeanor arrests or convictions; federal or state (any state) tax liens; unsatisfied final judgements(s); eviction involving any property or space used as an abortion facility or health care facility in any state; injunctive orders from any court; or unresolved final federal or state (any state) Medicare or Medicaid audit exceptions.

The language regarding change of ownership has been clarified. When an abortion facility changes ownership, the buyer must submit a license application and license fee for initial license at least 60 calendar days prior to the desired date of the change ownership. The department is required to survey the facility within 60 days of the change of ownership. A facility is required to report business changes that affect the condition of a license within 15 calendar days of the effective date of the change.

New §§139.31 - 139.34 establish the provisions for enforcement of the rules. Specifically, the sections cover on-site surveys and complaint investigations; license denial, suspension, and revocation; administrative penalties; and recovery of costs.

New §139.31 establishes procedures for on-site surveys and complaint investigations. An on-site survey will determine if the requirements of the Act and the rules are being met. The department will conduct an on-site survey prior to issuing a first annual license and prior to renewing a facility license. These surveys will include a standard-by-standard evaluation of the facility. This section also includes procedures for the resolution of deficiencies. If the surveyor finds there is a deficiency(ies), the facility has the option to challenge any deficiency cited. Provisions for challenging a deficiency are included in this section as required by House Bill 2856. This section includes procedures for the investigation and resolution of valid complaints. The department will investigate all complaints relevant to the Act or these rules which are received against a licensed abortion facility.

New §139.32 states the reasons the department may refuse to issue or renew a license; the reasons the department may suspend or revoke a license; the reasons the department may suspend or revoke an existing valid license or disqualify a person from receiving a license because of a person's conviction of a felony or misdemeanor if the crime directly relates to the duties and responsibilities of a licensed facility; the procedures for notification of a proposed denial, suspension, or revocation of a license; and the procedures for suspending or revoking a license on an emergency basis. A facility which has had an enforcement action that resulted in license revocation, suspension, emergency suspension, or denial or injunctive action may not reapply for a license for one-year following the effective date of the enforcement action. If the department suspends a license, the suspension will remain in effect until the department determines that the reason for the suspension no longer exists. Following an on-site survey in which deficiencies are cited, a facility may surrender its license before the expiration or allow its license to expire in lieu of the department proceeding with enforcement action. If a facility surrenders its license or allows the license to expire, the facility may not reapply for a license for six months.

New §139.33 implements Senate Bill 407 which provides the department with the authority to assess administrative penalties against a person who violates the Act or a rule adopted under the Act. If, after an investigation of a possible violation and the facts surrounding that possible violation, the department determines that a violation has occurred, the department will give written notice of the violation to the person alleged to have committed the violation. In determining the amount of an administrative penalty to be assessed the department will consider the seriousness of the violation; the history of any previous violations; the amount necessary to deter future violations; any efforts made to correct the violation; and any other matters that justice may require. This section includes procedures for requesting a hearing and for requesting a judicial review of the commissioner of health's order, if the person so desires. A civil or administrative penalty collected under this section will be deposited in the state treasury to the credit of the general revenue fund.

New §139.34 establishes procedures for the recovery of "reasonable" expenses and costs against a person in an administrative hearing if, as a result of the hearing, the person's license is denied, suspended, or revoked or if administrative penalties are assessed against the person.

New §§139.41 - 139.60 establishes the minimum standards for licensed abortion facilities. Specifically, the sections cover policy development and review; delegation of authority and organizational structure; personnel policies; orientation, training, and demonstrated competency; personnel records; abortion facility staffing requirements and qualifications; facility administration; physical and environmental requirements; infection control standards; disclosure requirements; patient rights; patient education/information services; medical and clinical services; health care services; clinical records; emergency services; discharge and follow-up procedures; reporting requirements; anesthesia services; and other state and federal compliance requirements. The minimum standards for abortion facilities were developed with the advice of the Abortion Facility Ad Hoc Rules Task Force. Three subcommittees of the Task Force were appointed to work on three specific areas of concern: sterilization (infection control) issues, quality of care issues, and personnel qualification issues. The Task Force members include: a physician representative from Planned Parenthood of San Antonio; a representative from the Texas Family Planing Association; a nurse representative from the Association of Operating Room Nurses; an advocate representative from the Life Network and Heidi Group; a licensed mental health practitioner representative from Rio Grande Counseling Center; a facility owner representative from Fort Worth; and department representatives (a physician from the Division of Women's Health; a physician/epidemiologist from the Infectious Disease, Epidemiology, and Surveillance Division; a statistical analyst from the Bureau of Vital Statistics; the program director for the Abortion Facility Licensing Program, Health Facility Licensing Division (HFL); and a program specialist from the Rules and Policy Development Section, HFL.

New §139.41 requires an abortion facility to develop, implement, enforce, and monitor written administrative policies; clinical policies; a policy concerning the prohibition of illegal remuneration for soliciting patient or patronage; a fire safety policy; and policies on decontamination, disinfection, and sterilization, and storage of sterile supplies.

New §139.42 requires the licensee to appoint a medical consultant to be responsible for implementing and enforcing the clinical policies of the facility, and supervising all medical services provided at the facility; and to appoint an administrator to be responsible for implementing and supervising the administrative policies of the facility.

New §§139.43 - 139.44 require the licensee to develop, implement, and enforce policies which shall govern all personnel staffed by the center; and to develop and implement a written orientation and training program to familiarize all employees with the facilities policies, philosophy, job responsibilities of all staff, and emergency procedures. New §139.45 contains the minimum requirements for personnel records that must be maintained by the facility on each employee.

New §139.46 establishes the minimum staffing requirements and qualifications for licensed abortion facilities. An abortion facility is required to have an adequate number of qualified personnel to provide direct patient care and administrative and non-clinical services needed to maintain the operation of the facility. The minimum qualifications have been established for the medical consultant, the administrator, direct patient care staff, ancillary staff, and anesthesia staff. The medical consultant is required to be a physician licensed to practice medicine in the State of Texas. The administrator is required to either be a licensed health care professional; have a baccalaureate degree, a post graduate degree, or a professional degree and one year administrative experience in a health care or health-related field; or have a minimum of two years of administrative experience in a health care or health-related facility. The administrator must not have been employed in the last year as an administrator with another abortion facility or health-related facility at the time the facility was cited for violations of a licensing law or rule which resulted in enforcement action (license revocation, suspension, emergency suspension, or denial or injunctive action) taken against the abortion facility or health-related facility. An enforcement action 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 does not apply. Also, the administrator must not have been convicted of certain felonies or misdemeanors. The staff providing medical services must include a physician licensed to practice medicine in the State of Texas and may include advanced practice nurses and physician assistants. The nursing staff includes registered nurses or licensed vocational nurses. The staff providing the education and information services (formerly called counseling services) at a facility must be trained to provide information on abortion procedures, alternatives, consent form, and family planning services and either have one year experience in a health care facility, have a baccalaureate degree in a counseling related field, or be a licensed professional mental health practitioner. The laboratory staff must have at least a high school education or general equivalency degree (GED) and specific training as determined and prescribed by the medical consultant. All ancillary staff must have training and experience as prescribed by the administrator and the medical consultant. The anesthesia staff must meet the minimum staffing requirements and qualifications for each level of sedation as established in §139.59 relating to anesthesia services.

New §139.47 establishes the minimum responsibilities of the administrator of a facility. The main responsibility of an administrator will be to implement and supervise the administrative policies of the facility to ensure that facility operations comply with the Act and the rules adopted thereunder.

The physical and environmental requirements have been updated and clarified in §139.48 to ensure that all patients of a licensed abortion facility are cared for in safe and sanitary environment and with equipment essential to the health and welfare of the patients. A new standard has been added to require that a facility must have the capacity to provide liquids to its patients and may provide commercially packaged food in individual servings. If other food is provided by the facility, it will be subject to the department's food service sanitation standards adopted at 25 TAC §§229.161 - 229.171.

The department has identified the need for more stringent and standardized infection control standards for the prevention and control of the transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Mycobacterium tuberculosis (TB), and Streptococcus species (SP). New §139.49 establishes the minimum standards for infection control. These standards include universal/standard precautions; educational course requirements; cleaning and laundry requirements; and decontamination, disinfection, sterilization, and storage of sterile supplies. The standards for decontamination, disinfection, sterilization, and storage of sterile supplies are specifically stated in the rules for the purposes of ensuring a high standard of infection control and to standardize the infection control process. An abortion facility will be required to have written policies and procedures for the decontamination and sterilization activities performed at the facility. The policies include, but are not limited to, receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of reusable items, as well as for assembly, wrapping, storage, distribution, and quality control of sterile items and equipment.

New §139.50 contains the disclosure requirements which require a facility to provide to a woman at the time of initial on-site consultation with the facility a written statement indicating the number of a toll-free telephone line which will be maintained by the department to provide specific information relating to licensed abortion facilities in Texas which is mandated by Senate Bill 2856; and a written statement identifying the department as the responsible agency for facility complaint investigations.

New §139.51 establishes patient rights consistent with those of any other health care facilities. The licensee shall ensure that all patients are cared for in a manner and in an environment that enhances each patient's dignity and respect in full recognition of her individuality; receive care in a manner that maintains and enhances her self-esteem and self-worth; be allowed to make her own choice and self-determination; are ensured the right to personal privacy and confidentiality of her choices and decisions; have access to quality care and treatment consistent with available resources and generally accepted standards; and are allowed to ask additional questions after giving consent and to withdraw consent prior to the start of the procedure.

New §139.52 covers standards for patient education/information services. The existing standard refers to such services as counseling services. The terminology was changed to "patient education/information" because these services are considered more of an educational and informational nature and are not usually provided by a licensed mental health practitioner. New language was added, however, to require a facility to refer a patient to a licensed mental health practitioner who provides therapeutic intervention, if the facility determines that it is warranted.

New §139.53 establishes standards for the provision of medical and clinical services provided by an abortion facility. This section includes supervision and performance of medical and clinical services, informed consent, preoperative requirements, staffing requirements during and after the procedure, fetal tissue examination, discharge procedures, and disposal of special waste.

New §139.54 establishes standards for the provision of health care services. This section requires abortion facilities 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 comply with the facility's written policies and procedures. Provisions have been added to allow the administration of intravenous fluids or medications and extraction of blood for laboratory tests by licensed vocational nurses (LVNs) if the facility has documented that the LVN has received instruction and has demonstrated competence in performing such tasks. This section also covers the provision and supervision of health care services by student health care professionals.

New §139.55 covers the minimum standards for establishing and maintaining a clinical record for each patient. The requirements for clinical records have been updated to reflect current standards and allow inactive patient records to be maintained as an original, a microfilmed copy, an optical disc imaging system, or a certified copy. Inactive patient records are required to be retrievable within two hours by the facility. An abortion facility may not destroy patient records that relate to any matter that is involved in litigation if the center knows the litigation has not been finally resolved. In the event an abortion facility closes, provisions have been added for the preservation of inactive records to ensure compliance with the rules.

New §139.56 requires an abortion facility to have a readily accessible protocol in place for the management of medical emergencies. This section contains requirements for the transfer of patients requiring emergency care to a licensed hospital; and for personnel providing direct patient care.

New §139.57 covers discharge and follow-up referral procedures. This section requires an abortion facility to develop and implement written discharge instructions to be given to the patient upon discharge. The instructions must include a list of complications, a statement of the facility's plan to respond to the patient, and information concerning the need for a post-abortion examination. The facility must have a written policy and procedure for examination or referral of all patients who report complications and period review of the record keeping system for post-abortion complications to resolve potential problems. If a woman's death is a result of a complication of an abortion, the abortion facility is required to report the death to the department in accordance with the reporting requirements in §139.58.

New §139.59 establishes the minimum requirements for the various levels of sedation (anesthesia) used at a facility. This section defines the levels of sedation; the minimum staffing, training, and knowledge required for each level of sedation; the care management for each level of sedation; and the clinical and equipment standards required for each level of sedation.

New §139.60 specifically states other state and federal requirements that directly relate to the licensing of abortion facilities. The requirements include laboratory and pharmacy services, professional nurse and licensed vocational nurse reporting and peer review, occupational safety and health, physicians and physician assistants, prescription medical devices, and trade and consumer practices.

The proposed new sections do not address the issues of practice of the licensed professional health care staff in the abortion facility; however abortion facilities will be responsible for ensuring that licensed health professionals practice within their scope of practice while working in the facilities. The clinicians practicing in the centers are subject to their respective regulatory and licensing boards. Issues about practice and complaints will be referred to the appropriate licensing boards and do not fall within the purview of the abortion facility regulations.

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

Bernie Underwood, Chief of Staff Services, Health Care Quality and Standards, has determined that for each year of the first five-year period the sections are in effect, there will be fiscal implications as a result of enforcing or administering the sections as proposed. The effect on state government will be an estimated increase in revenue from the licensing fees of approximately $5,000 the first year that the sections will be in effect; and $77,500 each year thereafter for the next four years. The additional revenue generated will offset costs associated with administering these sections. There will be no effect on local government.

Ms. Underwood has also determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing the sections will be increased quality of care for the women choosing to have an abortion in a licensed abortion facility. There will be additional costs to small and large businesses, i.e. abortion facilities, as a result of the increase in licensing fees. First time applicants will be required to submit a fee of $1,000 for an initial license which will be effective for 120 days and will be required to submit an additional fee of $1,500 for a first annual license which will expire one year from the date of the issuance of the initial license. Subsequent renewal of a license will increase from $1000 annually to $2,500 annually. This represents an increase in costs to licensed facilities of $1,500 per year. The effective date of this fee increase will occur sometime in July, 1998. Other additional cost to abortion facilities, if any, will be based upon the facilities existing business structure and operation. There are no economic costs to persons (other than abortion facilities) who are required to comply with the sections as proposed. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Julia R. Beechinor, Director, Health Facility Licensing Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199, (Telephone (512) 834-6646). Comments will be accepted for a period of 30 days after publication of the proposal in the Texas Register . In addition, a public hearing will be held at the following time and place: 10:00 a.m., Wednesday, March 11, 1998, at the Texas Department of Health, Lecture Hall K-100, 1100 West 49th Street, Austin, Texas 78756.

Subchapter A. Abortion Facility Reporting and Licensing