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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 133HOSPITAL LICENSING
SUBCHAPTER LCENTERS OF EXCELLENCE FOR FETAL DIAGNOSIS AND THERAPY
RULE §133.225Program 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

Cont'd...

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