| (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.
|
