TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 133. HOSPITAL LICENSING

SUBCHAPTER K. HOSPITAL LEVEL OF CARE DESIGNATIONS FOR MATERNAL CARE

25 TAC §§133.201 - 133.210

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (DSHS), proposes new §133.201, concerning Purpose; §133.202, concerning Definitions; §133.203, concerning General Requirements; §133.204 concerning Designation Process; §133.205 concerning Program Requirements; §133.206, concerning Maternal Designation Level I; §133.207, concerning Maternal Designation Level II; §133.208, concerning Maternal Designation Level III; §133.209, concerning Maternal Designation Level IV; and §133.210, concerning Survey Team.

BACKGROUND AND PURPOSE

The purpose of the new sections is to comply with House Bill 15, 83rd Legislature, Regular Session, 2013, which added Health and Safety Code, Subchapter H, Hospital Level of Care Designations for Neonatal and Maternal Care, §§241.181 - 241.187. HB 3433, 84th Legislature, Regular Session, 2015, amended Health and Safety Code, Chapter 241 and requires the development of initial rules to create the neonatal/maternal level of care designation by March 1, 2018. This rulemaking addresses the maternal level of care designation only. The neonatal level of care designation rules were adopted in June 2016. The designation for maternal level of care is an eligibility requirement for Medicaid reimbursement. It is estimated that approximately 225 - 250 facilities will apply for one or both designations.

SECTION-BY-SECTION SUMMARY

Proposed new §133.201, Purpose, describes the purpose of Maternal Level of Care Designation for Subchapter K.

Proposed new §133.202, Definitions, lists the definitions of Maternal Level of Care Designation for Subchapter K.

Proposed new §133.203, General Requirements, identifies the four levels of maternal care; the role of the DSHS Office of Emergency Medical Services/Trauma Services (office) in the designation process; states that facilities seeking neonatal or maternal designation for Levels II-IV shall be surveyed through a DSHS approved organization; and also establishes Perinatal Care Regions.

Proposed new §133.204, Designation Process, addresses the application submittal; renewals of designations; designation fee schedule; surveyor credentials; and an appeal process. Initial applications will receive staggered designations. Renewals will be for the full three-year designation term.

Proposed new §133.205, Program Requirements, provides an outline of the general requirements each hospital must meet.

The criteria for the four levels of maternal designation are included in §133.206, Maternal Designation Level I; §133.207, Maternal Designation Level II; §133.208, Maternal Designation Level III; and §133.209, Maternal Designation Level IV. Conversely to the Trauma Designation requirements found in 25 TAC Chapter 157, Subchapter G, Emergency Medical Services Trauma Systems, Level IV is the highest level of care and Level I is the lowest level of care.

Proposed new §133.210, Survey Team, addresses the composition of the on-site survey team, criteria for surveyor credentials, conflict of interest, and confidentiality and privilege protection.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for the first year that the sections will be in effect, there will be fiscal implications to the state as a result of enforcing and administering the sections as proposed. For fiscal year 2018 and in subsequent years, staffing costs will be offset by revenue generated by level of care designation fees established to recover costs associated with administering the program. It is expected that approximately 225-250 facilities will apply for one or both designations and will pay the following fees: $250 for Level I (<=100 beds); $750 (>100 beds); $1,500 for Level II; $2,000 for Level III; and $2,500 for Level IV, which will be deposited to the General Revenue Dedicated Fund.

For each year of the first five years that the sections will be in effect, there may be fiscal implications for local governments should that governmental entity own and operate a hospital that becomes designated. DSHS would be required to assign the appropriate level of care designations and to review the designations every three years; initial designations would be required to be completed by August 31, 2020, for maternal services. Any hospital failing to meet at least the minimum requirements at the lowest level (Level I) of care designation would be prohibited from receiving a designation and would be unable to receive Medicaid reimbursement for maternal services beginning September 1, 2020.

The fiscal impact of prohibiting Medicaid reimbursement for maternal services for any hospital failing to meet the minimum requirements at the lowest level (Level I) of care designation cannot be determined. Until the system for assigning levels of care has been established, it cannot be determined whether or not any hospital would be prohibited from receiving Medicaid reimbursement.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the sections will be in effect:

(1) the proposed rules will create a government program;

(2) implementation of the proposed rules will create new employee positions;

(3) implementation of the proposed rules will not require an increase or decrease in future legislative appropriations;

(4) the proposed rules will require an increase in fees paid to the agency;

(5) the proposed rules will create new rules;

(6) the proposed rules will not expand, limit, or repeal an existing rule;

(7) the proposed rules will increase the number of individuals subject to the rules; and

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

SMALL BUSINESS AND MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS AND ECONOMIC COSTS TO PERSONS

Jane Guerrero, Director, Office of EMS/Trauma Systems, Consumer Protection Division, has determined that there could be an adverse impact on small businesses, micro-businesses, rural communities or persons if they operate a hospital. A hospital will be required to pay a non-refundable application fee for a three-year designation of maternal care for Levels I - IV that vary from $250 to $2,500 depending on the level of designation sought to cover the costs.

There is an additional cost to the hospital for an on-site survey to verify compliance with the requirements for designation of maternal care for Levels II - IV facilities. An on-site survey is not required for the Level I hospital. Although the survey organizations must be approved by the DSHS office, the office does not determine the fee that the survey organization may charge. Anticipated costs based upon similar survey types and can range from $6,000 up to $20,000.

A hospital seeking a renewal of designation will also be required to pay for the renewal application and survey fees.

IMPACT ON LOCAL EMPLOYMENT

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Ms. Guerrero has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections is that designation of hospitals will facilitate the maternal care at hospitals with the appropriate capabilities necessary to improve the maternal outcomes in Texas.

REGULATORY ANALYSIS

DSHS has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Government Code, §2007.043.

PUBLIC HEARING

A public hearing to receive comments on the proposal will be scheduled after publication in the Texas Register and will be held at 9:00 a.m. on December 20, 2017, at the Department of State Health Services, Main Campus, Room M100, 1100 West 49th Street, Austin, Texas. The meeting date will be posted on the Office of EMS and Trauma Systems website http://dshs.texas.gov/emstraumasystems/ruldraft.shtm. Please contact Elizabeth Stevenson at DSHS.EMS-TRAUMA@dshs.texas.gov for information.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Elizabeth Stevenson, Designation Manager, Office of EMS/Trauma Systems, Consumer Protection Division, Department of State Health Services, Mail Code 1876, P.O. Box 149347, Austin, Texas 78714-9347; by email to DSHS.EMS-TRAUMA@dshs.texas.gov; or by fax to (512) 834-6736. Comments will be accepted for 35 days following publication of this proposal in the Texas Register.

To be considered, comments must be submitted no later than 35 days after the date of this issue of the Texas Register. The last day to submit comments falls on a Friday; therefore, comments must be: (1) postmarked or shipped before the last day of the comment period; or (2) faxed or emailed by midnight on the last day of the comment period. When faxing or emailing comments, please indicate "Comments on Proposed Rule 25R048" in the subject line.

STATUTORY AUTHORITY

The new rules are authorized by Health and Safety Code, Chapter 241, which provides DSHS with the authority to adopt rules establishing the levels of care for maternal care, establish a process for assignment or amendment of the levels of care to hospitals, divide the state into perinatal care regions, and facilitate transfer agreements through regional coordination; and by Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Health and Safety Code, Chapter 1001.

The new rules are authorized by Health and Safety Code, Chapters 241 and 1001; and Government Code, Chapter 531.

§133.201.Purpose.

The purpose of this subchapter is to implement Health and Safety Code, Chapter 241, Subchapter H, Hospital Level of Care Designations for Neonatal and Maternal Care, which requires a level of care designation of maternal services to be eligible to receive reimbursement through the Medicaid program for maternal services.

§133.202.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) ACLS--Advanced Cardiovascular Life Support. A resuscitation course that was developed and is administered by the American Heart Association.

(2) Antepartum--The period beginning on the date of conception and ending on delivery.

(3) Attestation--A written statement, signed by the chief executive officer of the facility, verifying the results of a self-survey represent a true and accurate assessment of the facility's capabilities required in this subchapter.

(4) Available--Relating to staff who can be contacted for consultation at all times without delay.

(5) CAP--Corrective Action(s) Plan. A plan for the facility developed by the Office of EMS/Trauma Systems that describes the actions required of the facility to correct identified deficiencies to ensure compliance with the applicable designation requirements.

(6) Commission--The Health and Human Services Commission.

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

(8) Designation--A formal recognition by the executive commissioner of a facility's maternal care capabilities and commitment, for a period of three years.

(9) Executive commissioner--The executive commissioner of the Health and Human Services Commission.

(10) Immediately--Without delay.

(11) Infant--A child from birth to one year of age.

(12) Intrapartum--During labor and delivery or childbirth.

(13) Lactation consultant--A health care professional who specializes in the clinical management of breastfeeding.

(14) Maternal--Pertaining to the mother.

(15) MFM--Maternal Fetal Medicine.

(16) MMD--Maternal Medical Director.

(17) MPM--Maternal Program Manager.

(18) Neonate--An infant from birth through 28 completed days after.

(19) Obstetrics--Related to pregnancy, childbirth, and the postpartum period.

(20) Office--Office of Emergency Medical Services (EMS)/Trauma Systems.

(21) On-site--At the facility and able to rapidly arrive at the patient bedside for urgent requests.

(22) PCR--Perinatal Care Region.

(23) Perinatal--Of, relating to, or being the period around childbirth, especially the five months before and one month after birth.

(24) POC--Plan of Correction. A report submitted to the office by the facility detailing how the facility will correct any deficiencies cited in the survey report or documented in the self-attestation.

(25) Postpartum--The six-week period following pregnancy or delivery.

(26) QAPI Program--Quality Assessment and Performance Improvement Program.

(27) RAC--Regional Advisory Council as described in §157.123 of this title (relating to Regional Emergency Medical Services/Trauma Systems).

(28) Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

(29) TSA--Trauma Service Area as described in §157.122 of this title (relating to Trauma Service Areas).

(30) Urgent--Requiring immediate action or attention.

§133.203.General Requirements.

(a) The Office of Emergency Medical Services (EMS)/Trauma Systems (office) shall recommend to the Executive Commissioner of the Health and Human Services Commission (executive commissioner) the designation of an applicant/healthcare facility as a maternal facility at the level for each location of a facility, which the office deems appropriate.

(b) A healthcare facility is defined under this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.

(c) Each location shall be considered separately for designation and the office will determine the designation level for that location, based on, but not limited to, the location's own resources and level of care capabilities; Perinatal Care Region (PCR) capabilities; and compliance with Chapter 133 of this title (relating to Hospital Licensing).

(1) Level I (Basic Care). The Level I maternal designated facility will:

(A) provide care for pregnant and postpartum patients who are generally healthy, and do not have medical, surgical, or obstetrical conditions that present a significant risk of maternal morbidity or mortality; and

(B) have skilled personnel with documented training, competencies and annual continuing education specific for the patient population served.

(2) Level II (Specialty Care). The Level II maternal designated facility will:

(A) provide care for pregnant and postpartum patients with medical, surgical, and/or obstetrical conditions that present a low to moderate risk of maternal morbidity or mortality; and

(B) have skilled personnel with documented training, competencies and annual continuing education specific for the patient population served.

(3) Level III (Subspecialty Care). The Level III maternal designated facility will:

(A) provide care for pregnant and postpartum patients with low risk conditions to significant complex medical, surgical and/or obstetrical conditions that present a high risk of maternal morbidity or mortality;

(B) ensure access to consultation to a full range of medical and maternal subspecialists and surgical specialists, and behavioral health specialists;

(C) ensure capability to perform major surgery on-site;

(D) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians and/or Obstetrics and Gynecology physicians with obstetrics training and privileges in maternal care;

(E) have skilled personnel with documented training, competencies and annual continuing education, specific for the population served;

(F) facilitate transports; and

(G) provide outreach education to lower level designated facilities, including the Quality Assessment and Performance Improvement (QAPI) process.

(4) Level IV (Comprehensive Care). The Level IV maternal designated facility will:

(A) provide comprehensive care for pregnant and postpartum patients with low risk conditions to the most complex medical, surgical and/or obstetrical conditions and their fetuses, that present a high risk of maternal morbidity or mortality;

(B) ensure access to on-site consultation to a comprehensive range of medical and maternal subspecialists, surgical specialists and behavioral health specialists;

(C) ensure capability to perform major surgery on-site;

(D) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians and/or Obstetrics and Gynecology physicians with obstetrics training, experience and privileges in maternal care;

(E) have a maternal fetal medicine critical care team with expertise and privileges to manage or co-manage highly complex, critically ill or unstable maternal patients;

(F) have skilled personnel with documented training, competencies and annual continuing education, specific for the patient population served;

(G) facilitate transports; and

(H) provide outreach education to lower level designated facilities, including the QAPI process.

(d) Facilities seeking maternal facility designation shall be surveyed through an organization approved by the office to verify that the facility is meeting office-approved relevant maternal facility requirements. The facility shall bear the cost of the survey.

(e) PCRs.

(1) The PCRs are established for descriptive and regional planning purposes and not for the purpose of restricting patient referral.

(2) The PCRs will consider and facilitate transfer agreements through regional coordination.

(3) A written plan identifies all resources available in the PCRs for perinatal care, including resources for emergency and disaster preparedness.

(4) The PCRs are geographically divided by counties and are integrated into the existing 22 TSAs and the applicable Regional Advisory Council (RAC) of the TSA provided in §157.122 of this title (relating to Trauma Service Areas) and §157.123 of this title (relating to Regional Emergency Medical Services/Trauma Systems); will be administratively supported by the RAC; and will have fair and equitable representation on the board of the applicable RAC.

(5) Multiple PCRs can meet together for the purposes of mutual collaboration.

§133.204.Designation Process.

(a) Designation application packet. The applicant shall submit the packet that includes the following documents to the Office of EMS/Trauma Systems (office) within 120 days of the facility's survey date:

(1) an accurate and complete designation application form for the appropriate level of designation, including full payment of the designation fee as listed in subsection (d) of this section;

(2) any subsequent documents requested by the office;

(3) a completed maternal attestation and self-survey report for Level I applicants or a designation survey report, including patient case reviews if required by the office for Level II, III and IV applicants;

(4) a plan of correction (POC), detailing how the facility will correct any deficiencies cited in the survey report, to include: the corrective action; the title of the person responsible for ensuring the correction(s) is implemented; how the corrective action will be monitored; and the date by which the POC will be completed; and

(5) evidence of participation in the applicable Perinatal Care Region (PCR).

(b) Renewal of designation. The applicant shall submit the documents described in subsection (a)(1) - (5) of this section to the office not more than 180 days prior to the designation expiration date and at least 60 days prior to the designation expiration date.

(c) If a facility seeking designation fails to meet the requirements in subsection (a)(1) - (5) of this section, the application shall be denied.

(d) Non-refundable application fees for the three-year designation period are as follows:

(1) Level I maternal facility applicants, the fees are as follows:

(A) <=100 licensed beds, the fee is $250.00; or

(B) >100 licensed beds, the fee is $750.00.

(2) Level II maternal facility applicants, the fee is $1,500.00.

(3) Level III maternal facility applicants, the fee is $2,000.00.

(4) Level IV maternal facility applicants, the fee is $2,500.00.

(A) All completed applications, received on or before July 1, 2020, including the application fee, evidence of participation in the PCR, an appropriate attestation if required, survey report, and that meet the requirements of the requested designation level, will be issued a designation for the full three-year term.

(B) Any facility that has not completed an on-site survey to verify compliance with the requirements for a Level II, III or IV designation at the time of application must provide a self-survey and attestation and will receive a Level I designation. The office, at its sole discretion may recommend a designation for less than the full three-year term. A designation for less than the full three-year term will have a pro-rated application fee consistent with the one, two or three-year term length.

(C) A facility applying for Level I designation requiring an attestation may receive a shorter term designation at the discretion of the office. A designation for less than the full three-year term will have a pro-rated application fee.

(D) The office, at its discretion, may designate a facility for a shorter term designation for any application received prior to September 1, 2020.

(E) An application for a higher or lower level designation may be submitted at any time.

(e) If a facility disagrees with the level(s) determined by the office to be appropriate for initial designation or re-designation, it may make an appeal in writing not later than 60 days after issuance of the level determination to the director of the office. The written appeal must include a signed letter from the facility's governing board with an explanation of how the facility meets the requirements for the designation level.

(1) If the office upholds its original determination, the director of the office will give written notice of such to the facility not later than 30 days of its receipt of the applicant's complete written appeal.

(2) The facility may, not later than 30 days of the office's sending written notification of its denial, submit a written request for further review. Such written appeal shall then go to the director of the office.

(f) The surveyor(s) shall provide the facility with a written, signed survey report regarding their evaluation of the facility's compliance with maternal program requirements. This survey report shall be forwarded to the facility no later than 30 days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the office if it intends to continue the designation process.

(g) The office shall review the findings of the survey report and any POC submitted by the facility, to determine compliance with the maternal designation program requirements.

(1) A recommendation for designation shall be made to the executive commissioner based on compliance with the requirements.

(2) A maternal level of care designation shall not be denied to a facility that meets the minimum requirements for that level of care designation.

(3) If a facility does not meet the requirements for the level of designation requested, the office shall recommend designation for the facility at the highest level for which it qualifies and notify the facility of the requirements it must meet to achieve the requested level of designation.

(4) If a facility does not comply with requirements, the office shall notify the facility of deficiencies and required corrective action(s) plan (CAP).

(A) The facility shall submit to the office reports as required and outlined in the CAP. The office may require a second survey to ensure compliance with the requirements. The cost of the survey will be at the expense of the facility.

(B) If the office substantiates action that brings the facility into compliance with the requirements, the office shall recommend designation to the executive commissioner.

(C) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee.

(D) Membership on a designation review committee will:

(i) be voluntary

(ii) be appointed by the office director;

(iii) be representative of maternal care providers and appropriate levels of designated maternal facilities;

(iv) exclude any representative with a conflict of interest; and

(v) include representation from the office and the Perinatal Advisory Council.

(E) If a designation review committee disagrees with the office's recommendation for corrective action, the records shall be referred to the Associate Commissioner of the Consumer Protection Division for recommendation to the executive commissioner.

(F) If a facility disagrees with the office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with a hearing request referenced in §133.121 of this title (relating to Enforcement Action), and Government Code, Chapter 2001.

§133.205.Program Requirements.

(a) Designated facilities shall have a family centered philosophy. The facility environment for perinatal care shall meet the physiologic and psychosocial needs of the mothers, infants, and families. Parents shall have reasonable access to their infants at all times and be encouraged to participate in the care of their infants.

(b) Program Plan. The facility shall develop a written plan of the maternal program that includes a detailed description of the scope of services available to all maternal patients, defines the maternal patient population evaluated and/or treated, transferred, or transported by the facility, that is consistent with accepted professional standards of practice for maternal care, and ensures the health and safety of patients.

(1) The written plan and the program policies and procedures shall be reviewed and approved by the facility's governing body. The governing body shall ensure that the requirements of this section are implemented and enforced.

(2) The written maternal program plan shall include, at a minimum:

(A) Program policies and procedures that are:

(i) based upon current standards of maternal practice; and

(ii) adopted, implemented and enforced for the maternal services it provides;

(B) a periodic review and revision schedule for all maternal care policies and procedures;

(C) written triage, stabilization, and transfer guidelines for pregnant and postpartum patients that include consultation and transport services;

(D) written guidelines or protocols for prevention, early identification, early diagnosis, and therapy for conditions that place the pregnant or postpartum patient at risk for morbidity and/or mortality;

(E) provisions for unit specific disaster response to include evacuation of maternal patients and infants to appropriate levels of care;

(F) a Quality Assessment and Performance Improvement (QAPI) Program as described in §133.41 of this title (relating to Hospital Functions and Services). The facility shall demonstrate that the maternal program evaluates the provision of maternal care on an ongoing basis, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until a resolution is achieved. The maternal program shall measure, analyze, and track quality indicators and other aspects of performance that the facility adopts or develops that reflect processes of care and is outcome based. Evidence shall support that aggregate patient data is continuously reviewed for trends and data is submitted to the department as requested;

(G) requirements for minimal credentials for all staff participating in the care of maternal patients;

(H) provisions for providing continuing staff education, including annual competency and skills assessment that is appropriate for the patient population served;

(I) a perinatal staff registered nurse as a representative on the nurse staffing committee under §133.41 of this title; and

(J) the availability of all necessary equipment and services to provide the appropriate level of care and support of the patient population served.

(c) Medical Staff. The facility shall have an organized maternal program that is recognized by the medical staff and approved by the facility's governing body.

(1) The credentialing of the maternal medical staff shall include a process for the delineation of privileges for maternal care.

(2) The maternal medical staff will participate in ongoing staff and team based education and training in the care of the maternal patient.

(d) Medical Director. There shall be an identified Maternal Medical Director (MMD) and/or Transport Medical Director (TMD) as appropriate, responsible for the provision of maternal care services and credentialed by the facility for the treatment of maternal patients. The responsibilities and authority of the MMD and/or TMD shall include:

(1) examining qualifications of medical staff requesting maternal privileges and making recommendations to the appropriate committee for such privileges;

(2) assuring maternal medical staff competency in managing obstetrical emergencies, complications and resuscitation techniques;

(3) monitoring maternal patient care from transport if applicable, to admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Program;

(4) participating in ongoing maternal staff and team based education and training in the care of the maternal patient;

(5) overseeing the inter-facility maternal transport;

(6) collaborating with the MPM in areas to include: developing and/or revising policies, procedures and guidelines, assuring medical staff and personnel competency, education and training; and the QAPI Program;

(7) frequently leading and participating in the maternal QAPI meetings;

(8) ensuring that the QAPI Program is specific to maternal and fetal care, is ongoing, data driven and outcome based;

(9) clinically active and practicing physician participating in maternal care at the facility where medical director services are provided;

(10) maintaining active staff privileges as defined in the facility's medical staff bylaws; and

(11) developing collaborative relationships with other MMD(s) of designated facilities within the applicable Perinatal Care Region.

(e) Maternal Program Manager (MPM). The MPM responsible for the provision of maternal care services shall be identified by the facility and:

(1) be a registered nurse with perinatal experience;

(2) be a clinically active and practicing registered nurse participating in maternal care at the facility where program manager services are provided;

(3) has the authority and responsibility to monitor the provision of maternal patient care services from admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Program;

(4) collaborates with the MMD in areas to include: developing and/or revising policies, procedures and guide­lines; assuring staff competency, education, and training and the QAPI Program;

(5) frequently leads and participates in the maternal QAPI meetings;

(6) ensures that the QAPI Program is specific to maternal and fetal care, is ongoing, data driven and outcome based; and

(7) develops collaborative relationships with other MPM(s) of designated facilities within the applicable Perinatal Care Region.

§133.206.Maternal Designation Level I.

(a) Level I (Basic Care). The Level I maternal designated facility will:

(1) provide care for pregnant and postpartum patients who are generally healthy, and do not have medical, surgical, or obstetrical conditions that present a significant risk of maternal morbidity or mortality; and

(2) have skilled personnel with documented training, competencies and annual continuing education specific for the patient population served.

(b) Maternal Medical Director (MMD). The MMD shall be a physician who:

(1) is a family medicine physician or an obstetrics and gynecology physician, with obstetrics training and experience, and with privileges in maternal care;

(2) demonstrates administrative skills and oversight of the Quality Assessment and Performance Improvement (QAPI) program; and

(3) has completed annual continuing education specific to maternal care.

(c) Program Functions and Services.

(1) Triage and assessment of all patients admitted to the perinatal service.

(A) Pregnant patients who are identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility shall be transferred to a higher level neonatal designated facility prior to delivery unless the transfer is unsafe.

(B) Pregnant or postpartum patients identified with conditions and/or complications that require a higher level of maternal care shall be transferred to a higher level maternal designated facility unless the transfer is unsafe.

(2) Provide care for patients with uncomplicated pregnancies with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal and/or maternal care.

(3) An obstetrics and gynecology physician with obstetrics training and experience shall be available at all times.

(4) Medical, surgical and behavioral health specialists shall be available at all times for consultation appropriate to the patient population served.

(5) Ensure that a qualified physician or certified nurse midwife with appropriate physician back-up is available to attend all deliveries or other obstetrical emergencies.

(6) The primary physician or certified nurse midwife with competence in the care of pregnant patients, whose credentials have been reviewed by the MMD and is on call:

(A) shall arrive at the patient bedside within 30 minutes of an urgent request; and

(B) shall complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated conditions.

(7) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:

(A) shall operate under guidelines reviewed and approved by the MMD; and

(B) shall have a formal arrangement with a physician with obstetrics training and/or experience, and with maternal privileges who will:

(i) provide back-up and consultation;

(ii) arrive at the patient bedside within 30 minutes of an urgent request; and

(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.

(8) An on-call schedule of providers, back-up providers, and provision for patients without a physician will be readily available to facility and maternal staff and posted on the labor and delivery unit.

(9) Ensure that physicians providing back-up coverage shall arrive at the patient bedside within 30 minutes of an urgent request.

(10) Appropriate anesthesia, laboratory, pharmacy, radiology, respiratory therapy, ultrasonography and blood bank services shall be available on a 24-hour basis as described in §133.41 of this title (relating to Hospital Functions and Services) respectively.

(A) Anesthesia personnel with training and experience in obstetric anesthesia shall be available at all times and arrive to the patient bedside within 30 minutes of an urgent request.

(B) Laboratory and blood bank services shall have guidelines or protocols for:

(i) massive blood component transfusion;

(ii) emergency release of blood components; and

(iii) management of multiple blood component therapy.

(C) Medical Imaging Services.

(i) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.

(ii) There shall be regular monitoring of the preliminary versus final reading in the QAPI Program.

(iii) Basic ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times.

(iv) A portable ultrasound machine immediately available at all times to the labor and delivery and antepartum unit.

(D) A pharmacist shall be available for consultation at all times.

(11) Obstetrical Services.

(A) The ability to begin an emergency cesarean delivery and ensure the availability of a physician with the training, skills, and privileges to perform the surgery within a time period consistent with current standards of professional practice and maternal care.

(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.

(C) A trial of labor for patients with prior cesarean delivery shall have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.

(12) Resuscitation. The facility shall have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:

(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS and the skills to perform a complete resuscitation; and

(B) ensures that resuscitation equipment, including difficult airway management equipment for pregnant and postpartum patients, is immediately available at all times to the labor and delivery, antepartum and postpartum areas.

(13) The facility shall have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity and/or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:

(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage and/or coagulopathy;

(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;

(C) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;

(D) sepsis and/or systemic infection in the pregnant or postpartum patient;

(E) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;

(F) shoulder dystocia, including assessment of risk factors, counseling of patient, and multi-disciplinary management; and

(G) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.

(14) Perinatal Education. A registered nurse with experience in maternal care shall provide the supervision and coordination of staff education. Perinatal education for high risk events will be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.

(15) Support personnel with knowledge and skills in breastfeeding and lactation to meet the needs of maternal patients shall be available at all times.

(16) Social services, pastoral care and bereavement services shall be provided as appropriate to meet the needs of the patient population served.

(17) Dietician or nutritionist available with appropriate training and experience for population served in compliance with the requirements in §133.41 of this title.

§133.207.Maternal Designation Level II.

(a) Level II (Specialty Care). The Level II maternal designated facility will:

(1) provide care for pregnant and postpartum patients with medical, surgical, and/or obstetrical conditions that present a low to moderate risk of maternal morbidity or mortality; and

(2) have skilled personnel with documented training, competencies and annual continuing education specific for the patient population served.

(b) Maternal Medical Director (MMD). The MMD shall be a physician who:

(1) is a family medicine physician, an obstetrics and gynecology physician, or maternal fetal medicine physician, all with obstetrics training and experience, and with privileges in maternal care;

(2) demonstrates administrative skills and oversight of the Quality Assessment and Performance Improvement (QAPI) program; and

(3) has completed annual continuing education specific to maternal care, including complicated conditions.

(c) Program Functions and Services.

(1) Triage and assessment of all patients admitted to the perinatal service.

(A) Pregnant patients identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility shall be transferred to a higher level neonatal designated facility prior to delivery unless the transfer is unsafe.

(B) Pregnant or postpartum patients identified with conditions and/or complications that require a higher level of maternal care shall be transferred to a higher level maternal designated facility unless the transfer is unsafe.

(2) Provide care for pregnant patients with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal and/or maternal care.

(3) An obstetrics and gynecology physician with obstetrics training and experience, and with maternal privileges, shall be available at all times and arrives at the patient bedside within 30 minutes of an urgent request.

(4) A board certified maternal fetal medicine physician with maternal privileges shall be available at all times for consultation.

(5) Medical and surgical physicians shall be available at all times and arrive at the patient bedside within 30 minutes of an urgent request.

(6) Specialists, including behavioral health, shall be available at all times for consultation appropriate to the patient population served.

(7) Ensure that a qualified physician or certified nurse midwife with appropriate physician back-up is available to attend all deliveries or other obstetrical emergencies.

(8) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on-call:

(A) shall arrive at the patient bedside within 30 minutes of an urgent request; and

(B) shall complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated conditions.

(9) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:

(A) shall operate under guidelines reviewed and approved by the MMD; and

(B) shall have a formal arrangement with a physician with obstetrics training and/or experience, and with maternal privileges who will:

(i) provide back-up and consultation;

(ii) arrive at the patient bedside within 30 minutes of an urgent request; and

(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.

(10) An on-call schedule of providers, back-up providers, and provision for patients without a physician will be readily available to facility and maternal staff and posted on the labor and delivery unit.

(11) Ensure that the physician providing back-up coverage shall arrive at the patient bedside within 30 minutes of an urgent request.

(12) The appropriate anesthesia, laboratory, pharmacy, radiology, respiratory therapy, ultrasonography and blood bank services shall be available on a 24-hour basis as described in §133.41 of this title (relating to Hospital Functions and Services) respectively.

(A) Anesthesia personnel with training and experience in obstetric anesthesia shall be available at all times and arrive to the patient bedside within 30 minutes of an urgent request.

(B) An anesthesiologist with training and/or experience in obstetric anesthesia shall be available at all times for consultation.

(C) Laboratory and blood bank services shall be capable of:

(i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma and/or cryoprecipitate, and platelet products on-site at all times;

(ii) implementing a massive transfusion protocol;

(iii) ensuring guidelines for emergency release of blood components; and

(iv) managing multiple blood component therapy.

(D) Medical Imaging Services.

(i) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.

(ii) There shall be regular monitoring of the preliminary versus final reading in the QAPI Program.

(iii) Computed Tomography (CT) imaging and interpretation available at all times.

(iv) Basic ultrasonographic imaging for maternal or fetal assessment, including interpretation shall be available at all times.

(v) A portable ultrasound machine immediately available at all times to the labor and delivery and antepartum unit.

(E) A pharmacist shall be available for consultation at all times.

(13) Obstetrical Services.

(A) The ability to begin an emergency cesarean delivery and ensure the availability of a physician with the training, skills, and privileges to perform the surgery within a time period consistent with current standards of professional practice and maternal care.

(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.

(C) A trial of labor for patients with prior cesarean delivery shall have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.

(14) Resuscitation. The facility shall have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:

(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS and the skills to perform a complete resuscitation; and

(B) ensures that resuscitation equipment, for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas. Difficult airway management equipment shall be immediately available at all times to these areas.

(15) The facility shall have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity and/or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:

(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage and/or coagulopathy;

(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;

(C) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;

(D) sepsis and/or systemic infection in the pregnant or postpartum patient;

(E) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;

(F) shoulder dystocia, including assessment of risk factors, counseling of patient, and multi-disciplinary management; and

(G) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.

(16) The facility shall have nursing leadership and staff with training and experience in the provision of maternal nursing care who will coordinate with respective neonatal services.

(17) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, shall provide the supervision and coordination of staff education. Perinatal education for high risk events will be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.

(18) Support personnel with knowledge and skills in breastfeeding and lactation to meet the needs of maternal patients shall be available at all times.

(19) Social services, pastoral care and bereavement services shall be provided as appropriate to meet the needs of the patient population served.

(20) Dietician or nutritionist available with appropriate training and experience for population served in compliance with the requirements in §133.41 of this title.

§133.208.Maternal Designation Level III.

(a) A Level III (Subspecialty Care). The Level III maternal designated facility will:

(1) provide care for pregnant and postpartum patients with low risk conditions to significant complex medical, surgical and/or obstetrical conditions that present a high risk of maternal morbidity or mortality;

(2) ensure access to consultation to a full range of medical and maternal subspecialists, surgical specialists, and behavioral health specialists;

(3) ensure capability to perform major surgery on-site;

(4) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians and/or Obstetrics and Gynecology Physicians with obstetrics training and privileges in maternal care;

(5) have skilled personnel with documented training, competencies and annual continuing education, specific for the population served;

(6) facilitate transports; and

(7) provide outreach education to lower level designated facilities, including the Quality Assessment and Performance Improvement (QAPI) process.

(b) Maternal Medical Director (MMD). The MMD shall be a physician who:

(1) is a board certified obstetrics and gynecology physician with obstetrics training and experience, or a board certified maternal fetal medicine physician, both with privileges in maternal care;

(2) demonstrates administrative skills and oversight of the QAPI Program; and

(3) has completed annual continuing education specific to maternal care, including complicated conditions.

(c) If the facility has its own transport program, there shall be an identified Transport Medical Director (TMD). The TMD shall be a physician who is a board/certified maternal fetal medicine specialist or board certified obstetrics and gynecology physician with privileges and experience in obstetrical care and maternal transport.

(d) Program Functions and Services.

(1) Triage and assessment of all patients admitted to the perinatal service.

(A) Pregnant patients who are identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility shall be transferred to a higher level neonatal designated facility prior to delivery unless the transfer is unsafe.

(B) Pregnant or postpartum patients identified with conditions and/or complications that require a higher level of maternal care shall be transferred to a higher level maternal designated facility unless the transfer is unsafe.

(2) Provide care for pregnant patients with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal and/or maternal care.

(3) Supportive and emergency care shall be delivered by appropriately trained personnel for unanticipated maternal-fetal problems that occur requiring a higher level of maternal care, until the patient is stabilized or transferred;

(4) An obstetrics and gynecology physician with maternal privileges shall be on-site at all times and available for urgent situations.

(5) Maternal Fetal Medicine physician with inpatient privileges shall be available at all times for consultation and arrives at the patient bedside to co-manage patients.

(6) Intensive Care Services. The facility shall provide critical care services for critically ill pregnant or postpartum patients, including fetal monitoring in the Intensive Care Unit (ICU), respiratory failure and ventilator support, procedure for emergency cesarean, coordination of nursing care, and consultative or co-management roles to facilitate collaboration.

(7) Medical and surgical physicians, including critical care specialists, shall be available at all times and arrive at the patient bedside within 30 minutes of an urgent request.

(8) Consultation by a behavioral health professional, with training and/or experience in maternal counseling shall be available at all times and arrive for in-person visits when requested within a time period consistent with current standards of professional practice and maternal care.

(9) Ensure that a qualified physician, or a certified nurse midwife with appropriate physician back-up, is available to attend all deliveries or other obstetrical emergencies.

(10) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on call:

(A) shall arrive at the patient bedside within 30 minutes for an urgent request; and

(B) shall complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated and critical conditions.

(11) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:

(A) shall operate under guidelines reviewed and approved by the MMD; and

(B) shall have a formal arrangement with a physician with obstetrics training and/or experience, and with maternal privileges who will:

(i) provide back-up and consultation;

(ii) arrive at the patient bedside within 30 minutes of an urgent request; and

(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.

(12) An on-call schedule of providers, back-up providers, and provision for patients without a physician will be readily available to facility and maternal staff and posted on the labor and delivery unit.

(13) Ensure that the physician providing back-up coverage shall arrive at the patient bedside within 30 minutes for an urgent request.

(14) Anesthesia Services shall comply with the requirements found at §133.41 of this title (relating to Hospital Functions and Services) and shall have:

(A) anesthesia personnel with experience and expertise in obstetric anesthesia shall be available on-site at all times;

(B) a board certified anesthesiologist with training or experience in obstetric anesthesia in charge of obstetric anesthesia services;

(C) an anesthesiologist with training and/or experience in obstetric anesthesia, including critically ill obstetric patients available for consultation at all times, and arrive at the patient bedside within 30 minutes for urgent requests; and

(D) anesthesia personnel on call, including back-up contact information, posted and readily available to the facility and maternal staff and posted in the labor and delivery area.

(15) Laboratory Services shall comply with the requirements found at §133.41 of this title and shall have:

(A) laboratory personnel on-site at all times;

(B) a blood bank capable of:

(i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma, cryoprecipitate, and platelet components on-site at the facility at all times;

(ii) implementing a massive transfusion protocol;

(iii) ensuring guidelines for emergency release of blood components; and

(iv) managing multiple blood component therapy; and

(C) perinatal pathology services available.

(16) Medical Imaging Services shall comply with the requirements found at §133.41 of this title and shall have:

(A) personnel appropriately trained in the use of x-ray equipment available on-site at all times;

(B) advanced imaging, including computed tomography (CT), magnetic resonance imaging (MRI), and echocardiography available at all times;

(C) interpretation of CT, MRI and echocardiography within a time period consistent with current standards of professional practice and maternal care;

(D) basic ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times; and

(E) a portable ultrasound machine available in the labor and delivery and antepartum unit.

(17) Pharmacy services shall comply with the requirements found in §133.41 of this title and shall have a pharmacist with experience in perinatal pharmacology available at all times.

(18) Respiratory Therapy Services shall comply with the requirements found at §133.41 of this title and have a respiratory therapist immediately available on-site at all times.

(19) Obstetrical Services.

(A) The ability to begin an emergency cesarean delivery within a time period consistent with current standards of professional practice and maternal care.

(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.

(C) A trial of labor for patients with prior cesarean delivery shall have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.

(20) Resuscitation. The facility shall have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:

(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS and the skills to perform a complete resuscitation; and

(B) ensures that resuscitation equipment, including difficult airway management equipment for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas.

(21) The facility shall have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity and/or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:

(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage and/or coagulopathy;

(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;

(C) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;

(D) sepsis and/or systemic infection in the pregnant or postpartum patient;

(E) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;

(F) shoulder dystocia, including assessment of risk factors, counseling of patient, and multi-disciplinary management; and

(G) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.

(22) The facility shall have nursing leadership and staff with training and experience in the provision of maternal nursing care who will coordinate with respective neonatal services.

(23) The facility shall have a program for genetic diagnosis and counseling for genetic disorders, or a policy and process for consultation referral to an appropriate facility.

(24) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, shall provide the supervision and coordination of staff education. Perinatal education for high risk events will be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.

(25) Support personnel with knowledge and skills in breastfeeding to meet the needs of maternal patients shall be available at all times.

(26) A certified lactation consultant shall be available at all times.

(27) Social services, pastoral care and bereavement services shall be provided as appropriate to meet the needs of the patient population served.

(28) Dietician or nutritionist available with training and experience in maternal nutrition and can plan diets that meet the needs of the pregnant and postpartum patient shall comply with the requirements in §133.41 of this title.

§133.209.Maternal Designation Level IV.

(a) A Level IV (Comprehensive Care). The Level IV maternal designated facility will:

(1) provide comprehensive care for pregnant and postpartum patients with low risk conditions to the most complex medical, surgical and/or obstetrical conditions and their fetuses, that present a high risk of maternal morbidity or mortality;

(2) ensure access to on-site consultation to a comprehensive range of medical and maternal subspecialists, surgical specialists and behavioral health specialists;

(3) ensure capability to perform major surgery on-site;

(4) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians and/or Obstetrics and Gynecology physicians with obstetrics training, experience and privileges in maternal care;

(5) have a maternal fetal medicine critical care team with expertise and privileges to manage or co-manage highly complex, critically ill or unstable maternal patients;

(6) have skilled personnel with documented training, competencies and annual continuing education, specific for the patient population served;

(7) facilitate transports; and

(8) provide outreach education to lower level designated facilities, including the Quality Assessment and Performance Improvement (QAPI) process.

(b) Maternal Medical Director (MMD). The MMD shall be a physician who:

(1) is a board certified obstetrics and gynecology physician with expertise in the area of critical care obstetrics; or a board certified maternal fetal medicine physician, both with privileges in maternal care;

(2) demonstrates administrative skills and oversight of the QAPI Program; and

(3) has completed annual continuing education specific to maternal care, including complicated conditions.

(c) If the facility has its own transport program, there shall be an identified Transport Medical Director (TMD). The TMD shall be a physician who is a board certified maternal fetal medicine physician or board certified obstetrics and gynecology physician with obstetrics privileges, with expertise and experience in critically ill maternal transport.

(d) Program Functions and Services.

(1) Triage and assessment of all patients admitted to the perinatal service.

(A) Pregnant patients who are identified at high risk of delivering a neonate that requires a higher level of neonatal care shall be transferred to a higher level neonatal designated facility prior to delivery unless the transfer is unsafe.

(B) Pregnant or postpartum patients identified with conditions and/or complications that require a service not available at the facility, shall be transferred to an appropriate maternal designated facility unless the transfer is unsafe.

(2) Supportive and emergency care shall be delivered by appropriately trained personnel, for unanticipated maternal-fetal problems that occur during labor and delivery, through the disposition of the patient.

(3) A board certified obstetrics and gynecology physician with maternal privileges shall be on-site at all times and available for urgent situations.

(4) Ensure that a qualified physician, or a certified nurse midwife with appropriate physician back-up, is available to attend all deliveries or other obstetrical emergencies.

(5) Intensive Care Services. The facility shall have an adult Intensive Care Unit (ICU) and critical care capabilities for maternal patients, including:

(A) a comprehensive range of medical and surgical critical care specialists and advanced subspecialists on the medical staff;

(B) a maternal fetal medicine critical care team with experience and expertise in the care of complex or critically ill maternal patients available to co-manage maternal patients; and

(C) availability of obstetric nursing and support personnel with experience in care for critically ill maternal patients.

(6) Maternal Fetal Medicine Critical Care Team. The facility shall have a Maternal Fetal Medicine (MFM) critical care team with expertise to assume responsibility for pregnant or postpartum patients who are in critical condition or have complex medical conditions, including;

(A) co-management of ICU-admitted obstetric patients;

(B) an MFM team member with full obstetrical privileges available at all times for on-site consultation and management; and

(C) a board-certified MFM with expertise in critical care obstetrics to lead the team.

(7) Management of critically ill pregnant or postpartum patients, including fetal monitoring in the ICU, respiratory failure and ventilator support, procedure for emergency cesarean, coordination of nursing care, and consultative or co-management roles to facilitate collaboration.

(8) Behavioral Health Services.

(A) Consultation by a behavioral health professional, with experience in maternal and/or neonatal counseling shall be available on-site at all times for in-person visits when requested for prenatal, peri-operative, and postnatal needs of the patient within a time period consistent with current standards of professional practice and maternal care.

(B) Consultation by a psychiatrist, with experience in maternal and/or neonatal counseling shall be available for in-person visits when requested within a time period consistent with current standards of professional practice and maternal care.

(9) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on call:

(A) shall arrive at the patient bedside within 30 minutes for an urgent request; and

(B) shall complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated and critical conditions.

(10) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:

(A) shall operate under guidelines reviewed and approved by the MMD; and

(B) shall have a formal arrangement with a physician with obstetrics training and/or experience, and with maternal privileges who will:

(i) provide back-up and consultation;

(ii) arrive at the patient bedside within 30 minutes of an urgent request; and

(iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.

(11) An on-call schedule of providers, back-up providers, and provision for patients without a physician will be readily available to facility and maternal staff and posted on the labor and delivery unit.

(12) Ensure that the physician providing back-up coverage shall arrive at the patient bedside within 30 minutes for an urgent request.

(13) Anesthesia Services shall comply with the requirements found at §133.41 of this title (relating to Hospital Functions and Services) and shall have:

(A) anesthesia personnel with experience and expertise in obstetric anesthesia shall be available on-site at all times;

(B) a board certified anesthesiologist with training and/or experience in obstetric anesthesia in charge of obstetric anesthesia services;

(C) a board certified anesthesiologist with training and/or experience in obstetric anesthesia, including critically ill obstetric patients available for consultation at all times, and arrive at the patient bedside within 30 minutes for urgent requests; and

(D) anesthesia personnel on call, including back-up contact information, posted and readily available to the facility and maternal staff and posted in the labor and delivery area.

(14) Laboratory Services shall comply with the requirements found at §133.41 of this title and shall have:

(A) laboratory personnel on-site at all times;

(B) a blood bank capable of:

(i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma, cryoprecipitate, and platelet components on-site at all times;

(ii) implementing a massive transfusion protocol;

(iii) ensuring guidelines for emergency release of blood components; and

(iv) managing multiple blood component therapy; and

(C) perinatal pathology services available.

(15) Medical Imaging Services shall comply with the requirements found at §133.41 of this title and shall have:

(A) personnel appropriately trained in the use of x-ray equipment available on-site at all times;

(B) advanced imaging, including computed tomography (CT), magnetic resonance imaging (MRI), and echocardiography available at all times;

(C) interpretation of CT, MRI and echocardiography within a time period consistent with current standards of professional practice and maternal care;

(D) a radiologist with critical interventional radiology skills available at all times;

(E) advanced ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times; and

(F) a portable ultrasound machine available in the labor and delivery and antepartum unit.

(16) Pharmacy services shall comply with the requirements found in §133.41 of this title and shall have a pharmacist with experience in perinatal pharmacology available at all times.

(17) Respiratory Therapy Services shall comply with the requirements found at §133.41 of this title and shall have a respiratory therapist immediately available on-site at all times.

(18) Obstetrical Services.

(A) The ability to begin an emergency cesarean delivery within a time period consistent with current standards of professional practice and maternal care.

(B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.

(C) A trial of labor for patients with prior cesarean delivery shall have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.

(19) Resuscitation. The facility shall have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:

(A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS and the skills to perform a complete resuscitation; and

(B) ensures that resuscitation equipment, including difficult airway management equipment for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas.

(20) The facility shall have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity and/or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:

(A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage and/or coagulopathy;

(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;

(C) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;

(D) sepsis and/or systemic infection in the pregnant or postpartum patient;

(E) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;

(F) shoulder dystocia, including assessment of risk factors, counseling of patient, and multi-disciplinary management; and

(G) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.

(21) The facility shall have nursing leadership and staff with training and experience in the provision of maternal critical care who will coordinate with respective neonatal services.

(22) The facility shall have a program for genetic diagnosis and counseling for genetic disorders, or a policy and process for consultation referral to an appropriate facility.

(23) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, shall provide the supervision and coordination of staff education. Perinatal education for high risk events will be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.

(24) Support personnel with knowledge and skills in breastfeeding to meet the needs of maternal patients shall be available at all times.

(25) A certified lactation consultant shall be available at all times.

(26) Social services, pastoral care and bereavement services shall be provided as appropriate to meet the needs of the patient population served.

(27) Dietician or nutritionist available with training and experience in maternal nutrition and can plan diets that meet the needs of the pregnant and postpartum patient and critically ill maternal patient shall comply with the requirements in §133.41 of this title.

§133.210.Survey Team.

(a) The survey team composition shall be as follows:

(1) Level I facilities maternal program staff shall conduct a self-survey, documenting the findings on the approved office survey form. The office may periodically require validation of the survey findings, by an on-site review conducted by department staff.

(2) Level II facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum one obstetrics and gynecology physician and one maternal nurse, all approved in advance by the office and currently active in the management of maternal patients at a facility providing the same or a higher level of maternal care.

(3) Level III facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum one obstetrics and gynecology physician or maternal fetal medicine physician and one maternal nurse, all approved in advance by the office and currently active in the management of maternal patients at a facility providing the same or a higher level of maternal care. An additional surveyor may be requested by the facility or at the discretion of the office.

(4) Level IV facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum one obstetrics and gynecology physician, a maternal fetal medicine physician and one maternal nurse, all approved in advance by the office and currently active in the management of maternal patients at a facility providing the same level of maternal care.

(b) Office-credentialed surveyors must meet the following criteria:

(1) have at least three years of experience in the care of maternal patients;

(2) be currently employed and practicing in the coordination of care for maternal patients;

(3) have direct experience in the preparation for and successful completion of maternal facility verification and/or designation;

(4) have successfully completed an office-approved maternal facility site surveyor course and be successfully re-credentialed every four years; and

(5) have current credentials as follows:

(A) a registered nurse who has successfully completed an office-approved site survey internship; or

(B) a physician who is board certified in the respective specialty, and has successfully completed an office-approved site survey internship.

(c) All members of the survey team, except department staff, shall come from a Perinatal Care Region outside the facility's location and at least 100 miles from the facility. There shall be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.

(d) The survey team shall evaluate the facility's compliance with the designation criteria by:

(1) reviewing medical records; staff rosters and schedules; documentation of QAPI Program activities, including peer review; the program plan; policies and procedures; and other documents relevant to maternal care;

(2) reviewing equipment and the physical plant;

(3) conducting interviews with facility personnel and surveyors may meet privately with individuals or groups of personnel; and

(4) evaluating appropriate use of telemedicine capabilities where applicable.

(e) All information and materials submitted by a facility to the office under Health and Safety Code, §241.183(d), are subject to confidentiality as articulated in Health and Safety Code, §241.184, Confidentially; Privilege, and are not subject to disclosure under Government Code, Chapter 552, or discovery, subpoena, or other means of legal compulsion for release to any person.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on November 2, 2017.

TRD-201704442

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 17, 2017

For further information, please call: (512) 776-6972


SUBCHAPTER L. CENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY

25 TAC §§133.221 - 133.226

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (DSHS), proposes new §133.221, concerning Purpose; §133.222, concerning Definitions; §133.223, concerning General Requirements; §133.224, concerning Designation Process; new §133.225, concerning Program Requirements; and §133.226, Surveyors.

BACKGROUND AND PURPOSE

The purpose of the new sections is to comply with House Bill (HB) 2131, 84th Legislature, Regular Session, 2015, which added Health and Safety Code, Chapter 32, Subchapter D, Centers of Excellence for Fetal Diagnosis and Therapy, §§32.071 - 32.073. HB 2131 requires the development of rules to create a designation program for Centers of Excellence for Fetal Diagnosis and Therapy by March 1, 2018.

The Centers of Excellence for Fetal Diagnosis and Therapy designation is voluntary and will be awarded to a facility that is a Level IV Neonatal Level of Care designated facility, is a Level IV Maternal Level of Care designated facility, is verified by the American College of Surgeons as a Pediatric Surgery Center, and has met the Centers of Excellence for Fetal Diagnosis and Therapy criteria in these rules.

The Centers of Excellence for Fetal Diagnosis and Therapy designation would include comprehensive maternal, fetal, and neonatal health care for pregnant women with high risk medical complications and fetuses with congenital anomalies and genetic conditions. DSHS would be required to review the designations every three years. It is estimated that approximately 2 - 4 Texas facilities will apply for the designation.

SECTION-BY-SECTION SUMMARY

Proposed new §133.221, Purpose, describes the purpose of the Centers of Excellence for Fetal Diagnosis and Therapy designation for Subchapter L.

Proposed new §133.222, Definitions, lists the definitions of the Centers of Excellence for Fetal Diagnosis and Therapy designation for Subchapter L.

Proposed new §133.223, General Requirements, identifies requirements for the Centers of Excellence for Fetal Diagnosis and Therapy designation; the role of the Office of Emergency Medical Services (EMS)/Trauma Systems (office) in the designation process; and states that facilities seeking the Centers of Excellence for Fetal Diagnosis and Therapy designation shall be surveyed through a DSHS approved organization.

Proposed new §133.224, Designation Process, addresses the application submittal; designation fee schedule; and an appeal process.

Proposed new §133.225, Program Requirements, provides an outline of the general requirements each facility must meet.

Proposed new §133.226, Surveyors, addresses the composition of the on-site surveyors; criteria for surveyor credentials; conflict of interest; and confidentiality and privilege protection.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the sections will be in effect, there will be no additional fiscal impact for state government as duties can be performed within existing resources for the proposed sections.

It is anticipated that one hospital per year will be designated at a cost of $2,500 and that hospitals will not become designated until the beginning of fiscal year 2019. The fees are established to recover costs associated with administering the Centers of Excellence for Fetal Diagnosis and Therapy Program.

For each year of the first five years that the sections will be in effect, there may be fiscal implications for local governments should that governmental entity own and operate a facility that becomes designated. The number of designations for government owned facilities cannot be determined at this time.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the sections will be in effect:

(1) the proposed rules will create a government program and participation in this program is voluntary;

(2) implementation of the proposed rules will not affect the number of employee positions;

(3) implementation of the proposed rules will not require an increase or decrease in future legislative appropriations;

(4) the proposed rules will require an increase in fees paid to the agency;

(5) the proposed rules will create new rules;

(6) the proposed rules will not expand, limit, or repeal an existing rule;

(7) the proposed rules will increase the number of individuals subject to the rules; and

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

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

Jane Guerrero, Director, Office of EMS/Trauma Systems, Consumer Protection Division, has determined that there will be no adverse impact on small businesses, micro-businesses, or rural communities required to comply with the sections as proposed. Participation in the Centers of Excellence for Fetal Diagnosis and Therapy Designation is voluntary and not linked to Medicaid reimbursement for services. These rules are expected to impact two to four of the largest hospitals in Texas, if they choose to designate, which are considered neither small nor micro-businesses.

ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT

There are anticipated economic costs to persons who comply with the sections as proposed. Although the survey organizations must be approved by the DSHS office, the office does not determine the fee that the survey organization may charge. There is a cost to the applicant for an on-site survey to verify compliance with the requirements for designation of Centers of Excellence for Fetal Diagnosis and Therapy. The cost of the on-site survey(s) can range from $20,000 - $30,000.

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas.

PUBLIC BENEFIT

Ms. Guerrero has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections is that designation of hospitals will facilitate healthy fetal outcomes in this state.

REGULATORY ANALYSIS

DSHS has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Government Code, §2007.043.

PUBLIC HEARING

A public hearing to receive comments on the proposal will be scheduled after publication in the Texas Register and will be held on December 20, 2017, at 1:00 p.m. at the Department of State Health Services, Main Campus, M100, 1100 West 49th Street, Austin, Texas. The meeting date will be posted on the Office of EMS and Trauma Systems website http://dshs.texas.gov/emstraumasystems/ruldraft.shtm. Please contact Elizabeth Stevenson at DSHS.EMS-TRAUMA@dshs.texas.gov for information.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Elizabeth Stevenson, Designation Manager, Office of EMS/Trauma Systems, Consumer Protection Division, Department of State Health Services, Mail Code 1876, P.O. Box 149347, Austin, Texas 78714-9347; by email to DSHS.EMS-TRAUMA@dshs.texas.gov; or by fax to (512) 834-6736. Comments will be accepted for 35 days following publication of this proposal in the Texas Register.

To be considered, comments must be submitted no later than 35 days after the date of this issue of the Texas Register. The last day to submit comments falls on a Friday; therefore, comments must be: (1) postmarked or shipped before the last day of the comment period; or (2) faxed or emailed by midnight on the last day of the comment period. When faxing or emailing comments, please indicate "Comments on Proposed Rule 25R047" in the subject line.

STATUTORY AUTHORITY

The new rules are authorized by Health and Safety Code, §§32.071 - 32.073, which establishes authority to adopt rules; Health and Safety Code, Chapter 241, which provides DSHS with the authority to adopt rules establishing the levels of care for maternal care, establish a process for assignment or amendment of the levels of care to hospitals, divide the state into perinatal care regions, and facilitate transfer agreements through regional coordination; and by Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Health and Safety Code, Chapter 1001.

The new rules are authorized by Health and Safety Code, Chapters 32, 241 and Chapter 1001; and Government Code, Chapter 531.

§133.221.Purpose.

The purpose of this subchapter is to implement Health and Safety Code, Chapter 32, Subchapter D, Centers of Excellence for Fetal Diagnosis and Therapy designation, to achieve healthy fetal outcomes in this state.

§133.222.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Antenatal--Occurring or existing before birth, referring to both the care of the woman during pregnancy and the growth and development of the fetus.

(2) Available--Relating to staff who can be contacted for consultation at all times without delay.

(3) CEFDT--A facility designated as a Center of Excellence for Fetal Diagnosis and Therapy.

(4) Commission--The Health and Human Services Commission.

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

(6) Designation--A formal recognition by the department of a facility's fetal diagnosis and therapy care capabilities and commitment, for a period of three years.

(7) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.

(8) Fetal--Of, relating to, or being a fetus.

(9) CEFDTMD--CEFDT Medical Director.

(10) CEFDTPM--CEFDT Program Manager.

(11) Innovation--A new method of investigation or an experiment undertaken to benefit an individual patient.

(12) Level I evidence-based metrics--Evidence from a systematic review of all relevant randomized controlled trials (RCTs) or evidence-based clinical practice guidelines from major national perinatal organizations, based on systematic reviews of RCTs.

(13) Maternal--Pertaining to the pregnant patient or mother.

(14) Maternal-Fetal Patient--Pertaining to the pregnant patient and her fetus(es).

(15) Office--Office of Emergency Medical Services (EMS)/Trauma Systems.

(16) On-site--At the facility and able to rapidly arrive at the patient bedside for urgent requests.

(17) PCR--Perinatal Care Region.

(18) Perinatal--Of, relating to, or being the period around childbirth, especially the five months before and one month after birth.

(19) Research--An investigation or experiment undertaken to create generalized knowledge about a particular subject.

(20) Urgent--Requiring immediate action or attention.

§133.223.General Requirements.

(a) The Office of EMS/Trauma Systems (office) shall recommend to the Executive Commissioner of the Health and Human Services Commission (executive commissioner) the designation of an applicant/healthcare facility as a Center of Excellence for Fetal Diagnosis and Therapy for each location of a facility, which the office deems appropriate.

(b) A healthcare facility is defined under this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.

(c) Each location shall be considered separately for designation and the office will determine the designation for that location, based on, but not limited to, the location's own resources and level of care capabilities; Perinatal Care Region (PCR) capabilities; and compliance with Chapter 133 of this title, (relating to Hospital Licensing).

(d) A CEFDT shall:

(1) provide the highest level of maternal, fetal, and neonatal care for patients with the least to most complex fetal conditions;

(2) provide at a minimum, all fetal therapies and interventions proven effective antenatally based on level I evidence-based metrics;

(3) have skilled medical staff and personnel with documented training, competencies and continuing education specific for the patient population served;

(4) offer fetal diagnosis and therapy through an extensive multi-specialty clinical program that is affiliated and collaborates extensively with a medical school in this state;

(5) demonstrate a significant commitment to research in and advancing the field of fetal diagnosis and therapy;

(6) offer advanced training programs in fetal diagnosis and therapy;

(7) provide appropriate long-term monitoring and follow-up care for patients, including measuring short-term and long-term patient diagnostic and therapeutic outcomes;

(8) provide outreach and education to maternal and/or neonatal designated facilities, including the Quality Assessment and Performance Improvement (QAPI) process;

(9) hold current verification for maternal-fetal surgical care from an organization approved by the department;

(10) hold current verification from the American College of Surgeons as a Level I Children's Surgery Center;

(11) be designated by the department as a Level IV Maternal Level of Care facility;

(12) be designated by the department as a Level IV Neonatal Level of Care facility;

(13) participate in CEFDT meetings twice a year as determined by the department:

(A) for the purposes of mutual collaboration;

(B) to discuss inclusion criteria for fetal intervention and biopsychosocial outcome variables both short-term and long-term; and

(C) to participate in a multi-disciplinary performance improvement process; and

(14) have facility specific treatment outcomes vetted and approved by the department for public posting on the facility website for public access and/or redirect the public to the facility specific outcomes posted on the department's website.

(e) Facilities seeking designation shall be surveyed through an organization approved by the office to verify that the facility is meeting office-approved relevant requirements. The facility shall bear the cost of the survey.

§133.224.Designation Process.

(a) Designation application packet. The applicant shall submit the packet that includes the following documents, to the Office of EMS/Trauma Systems (office) within 120 days of the facility's verification for maternal-fetal surgical care:

(1) an accurate and complete designation application form for designation, including full payment of the designation fee as listed in subsection (d) of this section;

(2) evidence of current Level IV Neonatal designation;

(3) evidence of current Level IV Maternal designation;

(4) evidence of current verification for maternal-fetal surgical care, including patient case reviews;

(5) evidence of current verification from the American College of Surgeons as a Level I Children's Surgery Center, including patient case reviews;

(6) a letter of support from the facility's governing board supporting provisions for the collection and evaluation of short-term and long-term outcomes;

(7) evidence of participation in the CEFDT meetings twice a year;

(8) evidence of outcomes posted for public access; and

(9) any subsequent documents requested by the office.

(b) Renewal of designation. The applicant shall submit the documents described in subsection (a)(1) - (9) of this section to the office not more than 180 days prior to the designation expiration date and at least 60 days prior to the designation expiration date.

(c) If a facility seeking designation fails to meet the requirements in subsection (a)(1) - (9) of this section, the application shall be denied.

(d) Non-refundable application fee of $2,500.00 for the three-year designation period shall be submitted with the application or renewal.

(e) If a facility disagrees with the designation determination by the office for initial designation or renewal of designation, it may make an appeal in writing not later than 60 days after issuance of the determination to the director of the office. The written appeal must include a signed letter from the facility's governing board with an explanation of the basis for its appeal.

(1) If the office upholds its original determination, the director of the office will give written notice of such to the facility not later than 30 days of its receipt of the applicant's complete written appeal.

(2) The facility may, not later than 30 days of the office's issuance of written notification of its denial, submit a written request for further review. Such written appeal shall be submitted to the Associate Commissioner of the Consumer Protection Division (associate commissioner).

(f) The survey organization shall provide the facility with a written, signed survey report regarding their evaluation of the facility's compliance with the Centers of Excellence for Fetal Diagnosis and Therapy designation requirements. This survey report shall be forwarded to the facility no later than 30 days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the office if it intends to continue the designation process.

(g) The office shall review the application packet documents submitted by the facility, to determine compliance with the Centers of Excellence for Fetal Diagnosis and Therapy designation requirements.

(1) A recommendation for designation shall be made to the executive commissioner based on compliance with the designation requirements.

(2) A Centers of Excellence for Fetal Diagnosis and Therapy designation shall not be denied to a facility that meets the minimum requirements for designation.

(A) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee.

(B) Membership on a designation review committee will:

(i) be voluntary;

(ii) be appointed by the office director;

(iii) be representative of fetal diagnosis and therapy providers, and the highest levels of neonatal and maternal care designated facilities;

(iv) exclude any representative with a conflict of interest; and

(v) include representation from the office.

(C) If a designation review committee disagrees with the office's recommendation, the records shall be referred to the associate commissioner for recommendation.

(D) If a facility disagrees with the office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with a hearing request referenced in §133.121(9) of this title (relating to Enforcement Action), and Government Code, Chapter 2001.

§133.225.Program Requirements.

(a) A CEFDT shall provide patient-centered and family-centered health care. The environment for maternal-fetal care shall comprehensively meet the physiologic and psychosocial needs of the pregnant patient, their infants, and families.

(b) Program Plan. The CEFDT shall develop a written plan of an organized program that includes a detailed description of the scope of services available to the maternal-fetal patient, defines the maternal-fetal patient population evaluated and/or treated by the CEFDT, which is consistent with accepted professional standards of practice for maternal-fetal care, and ensures the health and safety of patients.

(1) The written plan and the program policies and procedures shall be reviewed and approved by the facility's governing body. The governing body shall ensure that the requirements of this section are implemented and enforced.

(2) The written program plan shall include, at a minimum:

(A) program policies and procedures that are:

(i) based upon current standards of fetal diagnosis and therapy practice; and

(ii) adopted, implemented and enforced for the maternal-fetal services it provides;

(B) a periodic review and revision schedule for all maternal-fetal care policies and procedures;

(C) a Quality Assessment/Performance Improvement (QAPI) Program as described in §133.41 of this title (relating to Hospital Functions and Services). The CEFDT shall demonstrate that the QAPI Program evaluates the provision of maternal-fetal care on an ongoing basis, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until a resolution is achieved. The QAPI Program shall measure, analyze, and track quality indicators or other aspects of performance that the CEFDT adopts or develops that reflect processes of care and is outcome based. Aggregate patient data must be continuously reviewed for trends. QAPI data must be submitted to the department as requested;

(D) appropriate follow up for all infants through an established referral process;

(E) short-term and long-term outcomes of the pregnant patient and her fetus(es) after fetal interventions will be monitored by the CEFDT;

(F) requirements for minimal credentials for all staff participating in the care of maternal-fetal patients;

(G) provisions for providing continuing staff education, including annual competency and skills assessment that is appropriate for the patient population served; and

(H) procedures to ensure the availability of all necessary equipment and services to provide the appropriate level of care and support of the patient population served.

(c) Medical Staff. The facility shall have an organized fetal therapy and diagnosis program that is recognized by the medical staff and approved by the facility's governing body. The credentialing of the medical staff shall include a process for the delineation of privileges for maternal-fetal care.

(d) CEFDT Medical Director (CEFDTMD). There shall be an identified CEFDTMD responsible for the provision of fetal therapy and diagnosis services and credentialed by the facility for the treatment of maternal-fetal patients.

(1) The CEFDTMD shall be a physician who:

(A) is a board certified maternal-fetal medicine (MFM) physician or a board certified pediatric surgeon, with additional training and expertise in maternal-fetal care and fetal interventions;

(B) demonstrates administrative skills and oversight of the CEFDT QAPI Program;

(C) completes annual continuing medical education specific to fetal medicine and/or fetal interventions;

(D) is a clinically active and practicing physician participating in maternal-fetal care and fetal interventions at the facility where medical director services are provided; and

(E) maintains active staff maternal-fetal privileges as defined in the facility's medical staff bylaws.

(2) The CEFDTMD shall have the authority and responsibility to monitor maternal-fetal patient care from outpatient navigation, admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Program.

(3) The responsibilities and authority of the CEFDTMD shall include:

(A) examining qualifications of medical staff requesting fetal diagnosis and therapy privileges and making recommendations to the appropriate committee for such privileges;

(B) collaborating with the CEFDTPM in areas to include: developing and/or revising policies, procedures and guidelines for maternal-fetal care, assuring medical staff and personnel competency, education and training in maternal-fetal care; and directing the QAPI Program that is specific to maternal-fetal care and fetal interventions, is ongoing, data driven and outcome based;

(C) frequently leading and participating in the CEFDT QAPI meetings;

(D) participating in CEFDT meetings twice a year as determined by the department; and

(E) providing an annual report of aggregate short-term and long-term outcomes data as requested by the department.

(e) CEFDT Program Manager (CEFDTPM). There shall be an identified CEFDTPM responsible for the provision of fetal diagnosis and therapy clinical care services for maternal-fetal patients.

(1) The CEFDTPM shall be a registered nurse who:

(A) has experience and/or training in maternal-fetal care and fetal interventions;

(B) demonstrates administrative skills and oversight of the CEFDT QAPI Program;

(C) completes annual continuing education specific to maternal-fetal care and fetal interventions; and

(D) is a clinically active and practicing registered nurse participating in maternal-fetal care at the facility where program manager services are provided.

(2) The CEFDTPM shall have the authority and responsibility to monitor maternal-fetal patient care from outpatient navigation, admission, stabilization, operative intervention(s) if applicable, through discharge, and inclusive of the QAPI Program.

(3) The responsibilities and authority of the CEFDTPM shall include:

(A) examining qualifications of staff providing maternal-fetal care services;

(B) collaborating with the CEFDTMD in areas to include: developing and/or revising policies, procedures and guidelines for maternal-fetal care, assuring medical staff and personnel competency, education and training in maternal-fetal care; and directing the QAPI Program that is specific to maternal-fetal care and fetal interventions, is ongoing, data driven and outcome based;

(C) frequently leading and participating in the CEFDT QAPI meetings;

(D) participating in CEFDT meetings twice a year as determined by the department; and

(E) providing an annual report of aggregate short-term and long-term outcomes data as requested by the department.

(f) The facility shall identify medical staff responsible for the provision of maternal-fetal care services, available for in person consultation, and credentialed by the facility for the treatment of maternal-fetal patients, to include:

(1) a board certified MFM physician, who shall:

(A) have primary responsibility for the direct, comprehensive, and coordinated medical care of patients undergoing fetal interventions; and

(B) be available at all times to the bedside within a time period consistent with current standards of professional practice and maternal-fetal care; and

(2) a board certified pediatric surgeon with training and expertise in fetal intervention;

(3) a board certified pediatric neurosurgeon with training and expertise in fetal intervention;

(4) a board certified neonatologist with training and expertise in the care of neonates following fetal interventions;

(5) a board certified pediatric cardiologist with expertise in the performance and interpretation of fetal echocardiography shall be available and provide interpretation within a time period consistent with current standards of professional practice and maternal-fetal care;

(6) a board certified anesthesiologist with expertise in maternal-fetal physiology and uterine relaxation methods shall be available at all times for consultation and to arrive at the bedside if anesthesia is required for fetal interventions;

(7) a board certified pediatric urologist;

(8) a board certified pediatric nephrologist;

(9) a board certified pediatric palliative care medicine physician; and

(10) other board certified pediatric subspecialists, including cardiovascular surgery, craniofacial surgery, gastroenterology, orthopedic surgery, plastic surgery and rehabilitative medicine.

(g) The identified medical staff responsible for the provision of maternal-fetal care services shall:

(1) complete annual continuing medical education specific to maternal-fetal care and fetal interventions;

(2) be a clinically active and practicing physician participating in maternal-fetal care and fetal interventions at the CEFDT; and

(3) maintain active staff fetal diagnosis and therapy privileges as defined in the facility's medical staff bylaws.

(h) Medical Ethicist. A medical ethicist with expertise in clinical perinatal medical ethics shall be an active member of the fetal diagnosis and therapy program, including frequent participation in conferences, and providing in person ethical consultations and participation in research.

(i) Genetic Counseling. Board eligible/certified genetic counselors or a board eligible/certified physician with specialized training in prenatal genetic counseling shall be available for in person prenatal consultation as requested.

(j) Palliative Care. Personnel with training and/or experience in palliative care shall be available on-site at all times for prenatal and postnatal counseling of families.

(1) Personnel shall have perinatal-specific training in the support of maternal and/or pediatric patients and families.

(2) Personnel shall be trained to organize clinical protocols, birth plans, and to provide staff education.

(k) Child Life Specialist. A child life specialist shall be available for in person consultation as requested and be licensed as a Certified Child Life Specialist.

(l) Clinical Coordinators shall be identified as the primary point of contact for the family.

(1) At least one Clinical Coordinator shall be a registered nurse with experience in maternal or neonatal care.

(2) Clinical Coordinators engaged in research shall have completed the research ethics training/human subjects' protection training as appropriate.

(m) Research Support.

(1) Identify a research coordinator who shall have a Certified Clinical Research Professional or a Certified Clinical Research Associate credential or equivalent.

(2) A research coordinator shall collect, analyze, and abstract data as needed for research and follow up of perinatal outcomes.

(n) Medical Imaging Services.

(1) A board certified pediatric radiologist with expertise in the interpretation of fetal Magnetic Resonance Imaging (MRI) shall be available and provide interpretation within 24 hours upon completion of study.

(2) A Perinatal Sonographer shall:

(A) be registered through the American Registry for Diagnostic Medical Sonography, Cardiovascular Credentialing International, American Registry for Radiologic Technologists, or an organization approved by the department; and

(B) have documented continuing education as required for advanced certifications, and demonstrate competence in mainstream fetal diagnostic ultrasounds and new diagnostic modalities as available.

(3) Ultrasound Imaging. The ultrasound unit shall be accredited by The American Institute of Ultrasound in Medicine or the American College of Radiology or an organization approved by the department.

(4) Fetal Echocardiography. The facility's Fetal Echocardiography program shall be accredited by The American Institute of Ultrasound in Medicine or the Intersocietal Accreditation Commission or an organization approved by the department.

(5) Magnetic Resonance Imaging (MRI). The facility's MRI program shall be accredited by The American College of Radiology or an organization approved by the department.

(o) Laboratory Services.

(1) Perinatal pathology services shall be available on-site.

(2) Reference lab capabilities, or agreements with specialized testing centers, shall be available for specialized testing for perinatal genetic testing, fetal conditions, and infections.

(p) CEFDT Innovation Committee (committee). A multidisciplinary, objective committee will review fetal interventions that are innovative, but not mainstream medicine or research.

(1) The committee shall include medical and nursing personnel with maternal-fetal knowledge and expertise, ethicists, genetic counselors, and non-medical patient advocates, as appropriate for the proposed study.

(2) The chair of the committee shall have an independent objective view of the proposed intervention.

(3) The members of the committee may or may not be directly involved with the CEFDT, but shall not be directly involved in the proposed innovation.

(4) The committee decisions shall be independent and without conflict of interest, either due to direct care of the patient or by affiliation or financial gain.

(5) Documentation of in-depth discussions and actions implemented will be maintained by the CEFDT.

(6) All non-standard fetal interventions shall have formal approval by the committee prior to the intervention.

(7) The committee has the final authority to approve or disapprove the innovative intervention.

(q) The CEFDT shall provide a monthly multidisciplinary conference, involving CEFDT medical staff, nurses, ethicists, and ancillary staff, to discuss the options for prenatal and postnatal management of fetal anomalies and other conditions. Emergent fetal interventions performed prior to the conference will be discussed at the next monthly meeting after the procedure. The facility shall maintain documentation of meetings, in depth discussion of the options, and plan for management for all fetal therapy patients.

§133.226.Surveyors.

(a) A CEFDT shall be surveyed by a team, approved by the office, which is multi-disciplinary and includes at a minimum one board certified physician that is active in the management of maternal-fetal patients and/or performs fetal interventions; and a nurse active in the management of maternal-fetal patients, at a facility providing the same level of maternal-fetal care. An additional surveyor may be requested by the facility or at the discretion of the office.

(b) Office-credentialed surveyors must meet the following criteria:

(1) have at least three years of experience in the care of maternal-fetal patients and/or fetal interventions;

(2) be currently employed and clinically practicing in the coordination of care for maternal-fetal patients and fetal interventions;

(3) have direct experience in the preparation for and successful completion of a Centers of Excellence for Fetal Diagnosis and Therapy verification and/or designation;

(4) have successfully completed an office-approved Centers of Excellence for Fetal Diagnosis and Therapy site surveyor course and be successfully re-credentialed every four years; and

(5) have current credentials as:

(A) a registered nurse with maternal-fetal experience who has successfully completed an office-approved site survey internship; or

(B) a physician who is board certified in the respective specialty, and has successfully completed an office-approved site survey internship.

(c) All surveyors, except department staff, shall come from a Perinatal Care Region outside the facility's location and at least 100 miles from the facility. There shall be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.

(d) The surveyors shall evaluate the facility's compliance with the designation criteria by:

(1) reviewing medical records; staff rosters and schedules; documentation of QAPI Program activities, including peer review; the program plan; policies and procedures; and other documents relevant to fetal diagnosis and therapy services;

(2) reviewing equipment and the physical plant; and

(3) conducting interviews with facility personnel; surveyors may meet privately with individuals or groups of personnel.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on November 2, 2017.

TRD-201704441

Barbara L. Klein

Interim General Counsel

Department of State Health Services

Earliest possible date of adoption: December 17, 2017

For further information, please call: (512) 776-6972


CHAPTER 138. DISPOSITION OF EMBRYONIC AND FETAL TISSUE REMAINS

25 TAC §§138.1 - 138.8

The Health and Human Services Commission (HHSC) proposes new rules for §138.1 concerning Purpose; §138.2 concerning Definitions; §138.3 concerning Scope, Exemptions; §138.4 concerning Application of this Chapter; §138.5 concerning Approved Methods of Treatment and Disposition; §138.6 concerning Storage, Handling, and Transport Authorization; §138.7 concerning Storage, Handling, and Transport Requirements; and §138.8 concerning Burial or Cremation Assistance Registry.

BACKGROUND AND PURPOSE

The proposed rules are required by Senate Bill 8, 85th Legislature, 2017, Regular Session, which added Texas Health and Safety Code, Chapter 697, relating to the disposition of embryonic and fetal tissue remains. This legislation requires HHSC to adopt rules to implement Chapter 697.

SECTION-BY-SECTION SUMMARY

New §138.1 explains the purpose of the rules is to implement Texas Health and Safety Code, Chapter 697, which requires the dignified disposition of embryonic and fetal tissue remains.

New §138.2 contains the definitions that apply to this chapter, including the definitions of embryonic and fetal tissue remains, cremation, incineration, and interment.

New §138.3 explains the scope of this chapter and exemptions, including fetal tissue donated under Texas Health and Safety Code, Chapter 173; embryonic and fetal tissue required to be released to the parent of an unborn child under Texas Health and Safety Code, §241.010; and embryonic and fetal tissue expelled or removed from the human body once the person is outside of a health care facility.

New §138.4 describes the application of this chapter to types of health care facilities including abortion facilities, ambulatory surgical centers, and hospitals; prohibits disclosure of confidential information; and states that this chapter does not require a birth or death certificate or a burial transit permit.

New §138.5 lists the authorized methods of treatment and disposition of embryonic and fetal tissue remains as interment, cremation, incineration followed by interment, or steam disinfection followed by interment and includes cremation standards and recordkeeping requirements.

New §138.6 allows anyone authorized by the Texas Commission on Environmental Quality or the Texas Funeral Services Commission to store or transport embryonic and fetal tissue remains and describes the required methods of storage, handling, and transport of embryonic and fetal tissue remains.

New §138.7 lists the requirements for the proper storage, handling and transport of embryonic and fetal tissue remains.

New §138.8 establishes a registry of entities willing to provide or assist with free common burials or free or low-cost private burials of embryonic and fetal tissue remains. This section also includes the procedures for inclusion and removal from the registry list and how to request the registry list.

FISCAL NOTE

Greta Rymal, HHSC Deputy Executive Commissioner for Financial Services, has determined that for each year of the first five years that the sections will be in effect, there will be no fiscal implications to state or local governments as a result of enforcing and administering the sections as proposed.

GOVERNMENT GROWTH IMPACT STATEMENT

HHSC has determined that during the first five years that the sections will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of employee positions;

(3) implementation of the proposed rules will not require an increase or decrease in future legislative appropriations;

(4) the proposed rules will not affect fees paid to the agency;

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

(6) the proposed rules will expand existing rules;

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

(8) The rules are unlikely to have a significant impact on the state's economy because fetal tissue disposition is currently regulated. Although these rules are likely to have neutral impact on the state's economy, HHSC lacks sufficient data to predict the impact with certainty.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS AND ECONOMIC COSTS TO PERSONS

Ms. Rymal estimates that 236 health care facilities may be small or micro-businesses, handle tissue resulting from induced or spontaneous abortions, and may be affected by these requirements. Based on the current rules and information available to HHSC, health care facilities required to comply with the rules, currently provide for or contract for the disposition of embryonic and fetal tissue. The proposed rules prescribe alternative methods of disposition of embryonic and fetal tissue. These proposed alternatives may have a small incremental cost but that cost is expected to be off-set by the cost currently being expended for disposition. Different costs may arise based on a health care facility's decisions regarding the use of burial or cremation. The proposed rules allow the disposition of remains together, thereby reducing costs to an amount estimated to be commensurate with current methods used for disposition. HHSC notes that in comments submitted previously, private parties have offered to bury embryonic and fetal remains without charge. Other parties may also offer discounted or free services associated with the disposition of embryonic and fetal tissue. For these reasons, HHSC estimates little to no fiscal impact.

The previous fiscal impact review identified a per facility, per year cost of $425 for cremation and burial. Costs of burial ranged between $300 and $1,500 and costs of cremation were estimated at $125. Common cremation and/or burial are permissible under these rules, so these costs will not be a per procedure cost. If there is a realized increased cost to small businesses or rural communities, HHSC has determined that there are no alternatives of achieving the purpose of the proposed rule because new Chapter 697 requires each health care facility to comply with state law. Further, there are multiple low-cost alternatives that a small or micro business may use to achieve compliance with the law and rules. In testimony submitted in Whole Woman's Health v Hellerstedt, Case No. A-16-CA-1300-SS, US District Court, Western District of Texas, Austin Division, witnesses stated that they identified a provider who could comply with the revised embryonic and fetal disposition rules at an anticipated increased cost of between $.52 and $1.56 per patient. Additionally, the testimony in that case demonstrated that there was at least one private and one charitable organization that stated that they would provide disposition in compliance with these rules throughout the state.

IMPACT ON LOCAL EMPLOYMENT

There is no anticipated negative impact on local employment.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to implement Senate Bill 8, 85th Legislature, 2017, Regular Session.

PUBLIC BENEFIT

David Kostroun, HHSC Deputy Executive Commissioner of Regulatory Services, has determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of adopting and enforcing these rules will express the state's profound respect for the life of the unborn by providing for the dignified disposition of embryonic and fetal tissue remains.

REGULATORY ANALYSIS OF MAJOR ENVIRONMENTAL RULES

HHSC has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

HHSC has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted to the Health and Human Services Commission, Mail Code 1065, P.O. Box 13247, Austin, Texas 78711, or by email to Regulatory_Rules_Comments@hhsc.state.tx.us. Please specify "Comments on Chapter 697 Proposed Rules" in the subject line. HHSC intends by this section to invite public comment on each of the new rules. Comments are accepted for 30 days following publication of the proposal in the Texas Register.

To be considered, comments must be submitted no later than 30 days following publication of the proposal in the Texas Register. The last day to submit comments falls on a Sunday; however, comments postmarked, shipped, or emailed before midnight on the following Monday will be accepted.

STATUTORY AUTHORITY

Texas Health and Safety Code, Chapter 697, as adopted in Senate Bill 8, 85th Legislature, 2017, Regular Session, requires the dignified disposition of embryonic and fetal tissue remains. New Texas Health and Safety Code, §697.009, requires the Executive Commissioner to adopt rules governing new Chapter 697. Texas Government Code, §531.0055, authorizes the Executive Commissioner to adopt rules and policies necessary for the operation and provision of health and human services.

The new rules are authorized by Texas Health and Safety Code, Chapter 697, and Texas Government Code, Chapter 531.

In addition to the express authority of Chapter 697 of the Health and Safety Code, HHSC took into consideration a variety of statutes that express the Legislature's will to afford the level of protection and dignity to unborn children as state law affords to adults and children. See, e.g., Texas Penal Code, §1.07(26) (defining "individual" to include "an unborn child at every stage of gestation from fertilization until birth"); Texas Civil Practice and Remedies Code, §71.001(4) (defining "individual" in the wrongful death statute to include "an unborn child at every stage of gestation from fertilization until birth"); Texas Estates Code, §1002.002 (allowing for appointment of attorney ad litem for an unborn person in a guardianship proceeding); Texas Health and Safety Code, §241.010 (requiring hospitals to release to a parent remains of an unborn child who dies as a result of an unintended, intrauterine death). The rules carry out the agency's duty to protect public health in a manner that is consonant with the State's respect for life and dignity of the unborn. The agency accomplished this through amendments to the rules and inclusion of new provisions in the rules, including prohibiting the disposal of fetal tissue in a landfill and eliminating grinding as a method of fetal tissue disposition, that afford protection and dignity to the unborn consistent with the Legislature's expression of its intent. These rules provide a comparable level of protection to public health, while eliminating disposition options that are clearly incompatible with the Legislature's articulated objective of protecting the dignity of the unborn. The adopted rules meet the HHSC's duties under law, while properly weighing considerations regarding public health, overall public benefit, and costs.

Additional provisions considered include: Texas Penal Code, §1.07(26) relating to criminal penalties for harm to unborn person; Texas Civil Practice and Remedies Code, §71.001(4) relating to civil liability for killing unborn person; Texas Estates Code, §1054.007 relating to guardianship representation for unborn persons in a guardianship proceeding; Texas Estates Code, §1002.002 regarding the definition of "attorney ad litem" which includes representation of an "unborn person;" Texas Property Code, §115.014 relating to authority of a court to appoint a guardian ad litem to represent the interest of an unborn; Texas Health and Safety Code, §241.010 relating to requirement that hospitals release to a parent remains of an unborn child who dies as a result of an unintended, intrauterine death; Preamble of House Bill (HB) 2, 83rd Legislature, Second Called Session, 2013, effective October 29, 2013, relating to the compelling state interest in protecting the lives of unborn children from the stage at which substantial medical evidence indicates that an unborn child is capable of feeling pain is intended to be separate from and independent of the compelling state interest in protecting the lives of unborn children from the stage of viability, and neither state interest is intended to replace the other; Texas Health and Safety Code, §170.002 relating to the prohibition against a person intentionally or knowingly performing an abortion on a woman who is pregnant with a viable unborn child during the third trimester of the pregnancy; and Texas Health and Safety Code, §171.012 relating to requirement for sonograms of pre-viable unborn children before abortion.

§138.1.Purpose.

The purpose of this chapter is to implement the Health and Safety Code, Chapter 697, which requires the dignified disposition of embryonic and fetal tissue remains.

§138.2.Definitions.

The following words and terms, when used in this chapter, must have the following meanings unless the context clearly indicates otherwise.

(1) Burial--The act of depositing embryonic and fetal tissue remains in a grave, crypt, vault, or tomb, or at sea.

(2) Burial park--A tract of land that is used or intended to be used for the interment of embryonic and fetal tissue remains in graves.

(3) Cemetery--A tract of land that is used or intended to be used for the permanent interment of embryonic and fetal tissue remains, and includes:

(A) a burial park for earth interments;

(B) a mausoleum for crypt or vault interments;

(C) a columbarium for cinerary interments; or

(D) a combination of one or more of subparagraphs (A) - (C) of this paragraph.

(4) Columbarium--A structure or room or other space in a building or structure of most durable and lasting fireproof construction; or a plot of earth, containing niches, used, or intended to be used, to contain cremated embryonic and fetal tissue remains.

(5) HHSC--The Texas Health and Human Services Commission.

(6) Cremation--The irreversible process of reducing tissue or remains to ashes or bone fragments through direct flame, extreme heat, and evaporation.

(7) Crematory--A building or structure containing one or more furnaces used, or intended to be used, for the reduction (by burning) of human remains or embryonic and fetal tissue remains to cremated remains.

(8) Crypt or vault--The chamber in a mausoleum of sufficient size to inter the uncremated embryonic and fetal tissue remains.

(9) Entombment--The permanent interment of embryonic and fetal tissue remains in a crypt or vault.

(10) Embryonic and fetal tissue remains--An embryo, a fetus, body parts, or organs from a pregnancy that terminates in the death of the embryo or fetus and for which the issuance of a fetal death certificate is not required by state law. The term does not include the umbilical cord, placenta, gestational sac, blood, or body fluids.

(11) Executive Commissioner--The Executive Commissioner of the Health and Human Services Commission.

(12) Grave--A space of ground in a burial park that is used, or intended to be used for the permanent interment in the ground of embryonic and fetal tissue remains.

(13) Health care facilities--Include the following:

(A) ambulatory surgical centers;

(B) abortion clinics;

(C) birthing centers;

(D) clinics;

(E) emergency medical services;

(F) freestanding emergency medical care facilities;

(G) hospitals;

(H) professional offices, including the offices of physicians; and

(I) other health care-related facilities that provide health or medical care to a pregnant woman.

(14) Incineration--The process of burning embryonic and fetal tissue remains in an incinerator as defined in Title 30, Texas Administrative Code, Chapter 101 under conditions in conformance with standards prescribed in Title 30, Texas Administrative Code, Chapter 111 by the Texas Commission on Environmental Quality.

(15) Interment--The disposition of embryonic and fetal tissue remains by entombment, burial, or placement in a niche.

(16) Mausoleum--A structure or building of most durable and lasting fireproof construction used, or intended to be used, for the entombment of embryonic and fetal tissue remains.

(17) Niche--A recess or space in a columbarium used, or intended to be used, for the permanent interment of the cremated remains of embryonic and fetal tissue remains.

(18) Steam disinfection--The act of subjecting embryonic and fetal tissue remains to steam under pressure under those conditions which effect disinfection.

§138.3.Scope, Exemptions.

(a) Unless specifically exempted, all embryonic and fetal tissue remains from health care facilities must be treated as provided in this chapter.

(b) To the extent this chapter conflicts with Title 25, Texas Administrative Code, Chapter 1, Subchapter K, this chapter prevails.

(c) This chapter does not apply to:

(1) placentas designated for sale and obtained from a licensed hospital or a licensed birthing center;

(2) in vitro tissue cultures;

(3) human fetal tissue donated in accordance with Texas Health and Safety Code, Chapter 173;

(4) disposition of embryonic and fetal tissue remains of a single pregnancy, body parts, or tissue (including bulk blood), transferred for disposition to a licensed funeral director in accordance with Texas Health and Safety Code, Chapter 711, and Title 25, Texas Administrative Code Chapter 181 (relating to Vital Statistics), with the consent of the person or persons authorized to consent to the disposition of the fetal remains, body parts, or tissue (including bulk blood).

(5) human tissue, including embryonic and fetal tissue, that is expelled or removed from the human body once the person is outside of a health-care facility;

(6) embryonic and fetal tissue required to be released to the parent of an unborn child pursuant to Texas Health and Safety Code, §241.010; and

(7) a placenta removed from a hospital or birthing center pursuant to Texas Health and Safety Code, Chapter 172.

(d) Notwithstanding any other law or rule, the umbilical cord, placenta, gestational sac, blood, or body fluids from a pregnancy terminating in the death of the embryo or fetus for which the issuance of a fetal death certificate is not required by state law may be disposed of in the same manner as and with the embryonic and fetal tissue remains from that same pregnancy as authorized by this chapter.

§138.4.Application of this Chapter.

(a) This chapter may not be used to require or authorize disclosure of confidential information, including personally identifiable or personally sensitive information, not permitted to be disclosed by state or federal privacy or confidentiality laws.

(b) This chapter does not require the issuance of a birth or death certificate or a burial transit permit for the proper disposition of embryonic and fetal tissue remains from health care facilities.

(c) This chapter does not extend or modify requirements of Texas Health and Safety Code, Chapters 711 and 716, or Texas Occupations Code, Chapter 651, to disposition of embryonic and fetal tissue remains.

(d) This chapter applies to embryonic and fetal tissue remains from health care facilities.

§138.5.Approved Methods of Treatment and Disposition.

(a) Embryonic and fetal tissue remains, regardless of the period of gestation, except as provided by §138.3 of this chapter (relating to Scope, Exemptions), must be subjected to one of the following methods of treatment and disposal:

(1) interment;

(2) cremation;

(3) incineration followed by interment; or

(4) steam disinfection followed by interment.

(b) Embryonic and fetal tissue remains that undergo cremation must be placed in a cremation container that:

(1) is made of combustible materials suitable for cremation;

(2) provides a complete covering of the remains;

(3) is resistant to leakage or spillage; and

(4) protects the health and safety of crematory personnel.

(c) The ashes resulting from the cremation or incineration of embryonic and fetal tissue remains:

(1) may be interred or scattered in any manner authorized by law for human remains; and

(2) may not be placed in a landfill or sewer system.

(d) The facility treating the embryonic and fetal tissue remains must maintain records to document the treatment of the embryonic and fetal tissue remains from health care facilities processed at the facility as to method and conditions of treatment in accordance with Title 30, Texas Administrative Code, Chapter 326.

(e) The facility treating the embryonic and fetal tissue remains is responsible for establishing the conditions necessary for operation of each method used at the facility to ensure the reduction of microbial activity of any embryonic and fetal tissue remains.

(f) A health care facility responsible for disposing of embryonic and fetal tissue remains may coordinate with an entity in the registry established under §138.8 of this chapter, (relating to Burial or Cremation Assistance Registry), in an effort to reduce the cost associated with burial or cremation of the embryonic and fetal tissue remains.

§138.6.Storage, Handling, and Transport Authorization.

(a) Any person or entity that is licensed, permitted or otherwise authorized by the Texas Funeral Services Commission to store, handle or transport human remains is authorized to store, handle or transport embryonic and fetal tissue remains.

(b) Any person or entity that is licensed, permitted or otherwise authorized by the Texas Commission on Environmental Quality to store, handle or transport special waste from health care facilities is authorized to store, handle or transport embryonic and fetal tissue remains.

§138.7.Storage, Handling, and Transport Requirements.

(a) A container which contains untreated embryonic and fetal tissue remains must be placed in an outer container that is leak resistant, impervious to moisture, of sufficient strength to prevent tearing and bursting under normal conditions of use and handling, and sealed to prevent leakage.

(b) The outer container holding untreated embryonic and fetal tissue remains must be labeled with a warning legend in English and in Spanish, along with the international symbol for biohazardous material on the sides of the container. The wording of the warning legend must be substantially similar to the following: "CAUTION, contains material which may be biohazardous" and "PRECAUCIÓN, contiene material que pueden ser peligro biológico."

(c) Untreated embryonic and fetal tissue remains may be transported by the generating facility or must be released only to transporters using transportation units that:

(1) have a fully enclosed, leak-proof remains storage area;

(2) protect the remains from mechanical stress or compaction;

(3) carry spill cleanup equipment; and

(4) have a compartment where remains are transported that must:

(A) be maintained in a sanitary condition;

(B) be locked when the vehicle or trailer is in motion;

(C) be locked or secured when remains are present in the compartment except during loading or unloading of remains;

(D) have a floor and sides made of an impervious, nonporous material;

(E) have all discharge openings securely closed during operation of the vehicle or trailer;

(F) maintain a temperature of 45 degrees Fahrenheit or less for remains transported for longer than 72 hours during post-collection storage period; and

(G) be disinfected before being used to transport any material other than remains or untreated medical waste.

(d) Cremated embryonic and fetal tissue remains may be transported in any manner in this state and must be disposed of in accordance with this chapter.

§138.8.Burial or Cremation Assistance Registry.

The registry is created to identify persons or entities who choose to provide financial or other assistance for the cremation or burial of embryonic or fetal tissue remains.

(1) The following persons or entities may apply for inclusion on the registry by submitting an application on a form prescribed by HHSC:

(A) participating funeral homes and cemeteries willing to provide free common burials or free or low-cost private burials that certify that they will do so in compliance with applicable law; and

(B) private nonprofit organizations that will provide financial assistance for the costs associated with burial or cremation of embryonic and fetal tissue remains.

(2) An application will be approved if the applicant meets the requirements of paragraph (1) of this section.

(3) An application will be disapproved if the applicant has:

(A) not met the requirements in paragraph (1) of this section; or

(B) failed or refused to properly complete or submit any application form, or deliberately presented false information on any form or document required by HHSC.

(4) Upon approval of an application, the applicant's name will be placed on the registry. HHSC will provide notice of placement on the registry to each approved applicant.

(5) A person or entity may be removed from the registry at the sole discretion of HHSC upon evidence that a registrant has failed to provide the services for which it was placed on the registry. HHSC will notify, in writing, a registrant of its removal from the registry. The denial or removal from the registry is not subject to Texas Government Code, Chapter 2001.

(6) A request under this section will not be considered a petition for the adoption of rules.

(7) Obtaining Registry Information.

(A) HHSC will make the registry information available upon request to a physician, a health care facility, or the agent of a physician or health care facility.

(B) A request from a physician, a health care facility, or the agent of a physician or health care facility must be submitted to HHSC on a form prescribed by HHSC.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on November 6, 2017.

TRD-201704475

Karen Ray

Chief Counsel of Health and Human Services

Department of State Health Services

Earliest possible date of adoption: December 17, 2017

For further information, please call: (512) 424-6530