Current through Reg. 49, No. 38; September 20, 2024
(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.
