| (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.
Cont'd... |
