SECTION 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 at all times for in-person visits when requested for prenatal and postnatal counseling of families within a time period consistent with current standards of professional practice and maternal-fetal care.

(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.

Source Note: The provisions of this §133.225 adopted to be effective March 1, 2018, 43 TexReg 887