Current through all regulations passed and filed through September 16, 2024
(A)
A freestanding
children's hospital with a level IV neonatal care service may also provide a
level III obstetrical service. In addition to the requirements of paragraphs
(B) to (K) of rule
3701-7-11 of the Administrative
Code, a freestanding children's hospital with a level IV neonatal care service
and a level III obstetrical service shall provide antepartum, intrapartum and
postpartum care for obstetrical patients, including:
(1)
All low-risk
patients;
(2)
All uncomplicated patients with higher-risk
conditions;
(3)
All high-risk patients;
(4)
Patients with
more complex maternal or fetal conditions as identified by the service, such as
patients:
(a)
With suspected placenta accreta or placenta previa with prior uterine
surgery;
(b)
With suspected placenta percreta;
(c)
With adult
respiratory syndrome; or
(d)
Requiring expectant management of early severe
preeclampsia at less than thirty-four weeks of gestation;
(5)
Intensive care through an on-site intensive care unit that is equipped
to:
(a)
Provide
labor and delivery in the intensive care unit;
(b)
Provide medical
and surgical care of complex obstetrical conditions; and
(c)
Bring intensive
care unit services to the obstetrical unit;
(6)
The management of
unanticipated complications of labor and delivery; and
(7)
The management of
emergencies.
(B)
Obstetric transfer. A freestanding children's hospital
with a level IV neonatal care service and a level III obstetrical service shall
transfer to a level IV obstetric service care any pregnant woman for
intrapartum care:
(1)
With a complex medical condition that requires critical
care or intensive care beyond that which the facility can provide;
or
(2)
If the newborn is anticipated to need advanced medical
and surgical care beyond that which the transferring service is licensed to
provide.
Exception: A level III obstetrical
service may provide care where an emergency medical condition exists as defined
by the Emergency Medical Treatment and Labor Act,
42
U.S.C. 1395dd (2012), and is evidenced by the
following:
(a)
The mother is having contractions; and
(b)
When, in the
clinical judgment of a qualified obstetrical practitioner working under that
practitioner's scope of practice:
(i)
There is inadequate time to effect a safe transfer of
the mother to an appropriate higher level hospital before delivery;
or
(ii)
The transfer will pose a threat to the health or safety
of either the mother or the fetus.
(C)
When
considering a woman's condition and the likelihood of pregnancy-related
complications, paragraphs (A) and (B) of this rule do not preclude the
admission of:
(1)
A pregnant woman to the maternity unit for care or
services for a non-obstetrical issue, but that may require monitoring of the
health of the mother, the fetus, or both;
(2)
Women for
antepartum care at any stage of the maternity cycle where labor is not
imminent;
(3)
Non-infectious gynecologic patients; or
(4)
Non-infectious
female surgical patients in accordance with policies and procedures approved by
the service's director.
(D)
Informed consent.
When discussing transfer of a pregnant woman to another facility in accordance
with this rule, the transferring service shall document and provide the patient
or patient's legal guardian with:
(1)
The recommendations from any consultations with a level
IV obstetrical service;
(2)
The risks and benefits associated with the patient's
transfer or retention; and
(3)
Any other
information required by the hospital's policies and procedures.
(E)
In the
event the patient or patient's legal guardian refuses transfer to a recommended
hospital, the service shall document the refusal of transfer and provide
treatment to the patient or patients in accordance with hospital policies and
procedures. The service shall update the patient or patient's legal guardian as
the patient's condition warrants.
(F)
Written service
plan. Each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service shall, using licensed health care
professionals acting within the scopes of their practice, include in the
written service plan required by paragraph (C) of rule
3701-7-11 of the Administrative
Code:
(1)
The
more complex maternal or fetal conditions for which the care will be provided
based on the:
(a)
Patient population;
(b)
Acuity of
patients;
(c)
Volume of patients; and
(d)
Competency of
staff;
(2)
Criteria for determining those conditions that can be
routinely managed by the service;
(3)
Admission to the
service;
(4)
Discharge from the service;
(5)
A risk assessment
of obstetric patients to ensure identification of appropriate consultation
requirements for or referral of high-risk patients;
(6)
Education for
mothers regarding personal care and nutrition, newborn care and nutrition, and
newborn feeding;
(7)
Consultation for and referral of obstetric
transports;
(8)
The coordination and facilitation, on a twenty-four
hour basis, of obstetric transports;
(9)
Consultation for
maternal-fetal medicine on a twenty-four hour basis;
(10)
The provision of
opportunities for graduate medical education such as pediatric or
obstetrics-gynecology residencies;
(11)
Participation,
on an ongoing basis, in basic or clinical obstetrics research;
and
(12)
The provision of multi-disciplinary planning relating
to management and therapy through the postpartum period.
(G)
Each
freestanding children's hospital with a level IV neonatal care service and a
level III obstetrical service shall, in accordance with accepted standards of
practice, develop and follow written policies and procedures to implement the
additional component of the written service plan required by paragraph (F) of
this rule.
(H)
Each provider shall have the ability to perform all of
the following:
(1)
An emergency cesarean delivery in accordance with
facility policy, but no later than thirty minutes from the time that the
decision is made to perform the procedure;
(2)
Fetal monitoring;
and
(3)
Resuscitation and stabilization of newborns and
emergency care for the mother and newborn in each delivery
room.
(I)
Support services. Each freestanding children's hospital
with a level IV neonatal care service and a level III obstetrical service shall
have the support services required by paragraphs (E) and (F) of rule
3701-7-11 of the Administrative
Code available for adult obstetric patients.
(J)
Unit management.
In addition to the requirements of paragraphs (G) of rule
3701-7-11 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service shall have qualified individuals
on-staff appropriate for the services provided, including:
(1)
A board-certified
obstetrician director for the obstetrical service. The director of the
obstetrical service shall work with the director of the neonatal care service
required by paragraph (G)(1) of rule
3701-7-11 of the Administrative
Code to coordinate and integrate the requirements of paragraph (G)(1) of rule
3701-7-11 of the Administrative
Code, and to coordinate and integrate the following:
(a)
Coordination and
communication with support services and other obstetrical services;
and
(b)
Defining and establishing, in collaboration with other
members of the obstetric team, appropriate protocols and procedures for
obstetric patients.
(2)
A board-certified
maternal-fetal medicine subspecialist to serve as director of the
maternal-fetal medicine service;
(3)
A single,
designated registered nurse with a bachelor's degree in nursing and a master's
degree responsible for leading the organization and supervising the nursing
services in the obstetrical service;
(4)
A registered
nurse with a master's degree in nursing and an area of specialization in
perinatal care to provide clinical nursing expertise commensurate with the
patient acuity and services provided. The registered nurse required by
paragraph (G)(3) of rule
3701-7-11 of the Administrative
Code may meet this requirement with sufficient perinatal
expertise;
(5)
A director of obstetric anesthesia services who is a
board-eligible or board-certified anesthesiologist; and
(6)
A geneticist or
genetics counselor who is certified by the American college of medical genetics
or eligible for such certification to:
(a)
Identify
families at risk for genetic abnormalities;
(b)
Obtain family
genetic history;
(c)
Provide genetic counseling in complicated cases;
and
(d)
If necessary, refer complicated cases to an on-staff
medical geneticist.
(K)
Specialists. In
addition to the requirements of paragraph (H) of rule
3701-7-11 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service shall have medical, surgical,
radiological and pathology specialists either on-site or on-call based on the
medical needs of adult obstetric patients.
(L)
Sub-specialists.
In addition to the requirements of paragraph (I) of rule
3701-7-11 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service shall have qualified
sub-specialists available for consultation, and, if necessary, adult obstetric
patient care either on-site or at a nearby closely related hospital or
institution, appropriate for the services provided and based upon the medical
needs of the patient, that may include medical-surgical sub-specialists:
(1)
Maternal-fetal
medicine;
(2)
Critical care;
(3)
General
surgery;
(4)
Infectious disease;
(5)
Hematology;
(6)
Cardiology;
(7)
Nephrology;
and
(8)
Neurology.
(M)
For every
anticipated low-risk delivery or uncomplicated delivery with higher-risk
conditions, each provider shall have an obstetrician, physician, or certified
nurse midwife acting within their scope of practice and under a standard care
arrangement with a collaborating physician, in attendance.
For an unanticipated high risk
delivery, every attempt shall be made to secure a second physician or certified
nurse practitioner acting within their scope of practice and under a standard
care arrangement with a collaborating physician to care for the
neonate.
(N)
For every anticipated high-risk delivery, each provider
shall have in attendance:
(1)
An obstetrician or physician;
(2)
A second
physician or certified nurse practitioner acting within their scope of practice
and under a standard care arrangement with a collaborating physician to care
for the neonate; and
(3)
Members of the multi-disciplinary team required by
paragraph (Q) of this rule, one of whom can initiate resuscitation, and one of
whom can complete full resuscitation. This can be the same
individual.
(O)
For every delivery with more complex maternal or fetal
conditions, each provider shall have in attendance:
(1)
An obstetrician
or maternal fetal medicine specialist capable of performing a cesarean
section;
(2)
A neonatologist or physician to attend to the
neonate;
(3)
Maternal-fetal medicine or fetal surgeon, as
appropriate, during operative procedures; and
(4)
Members of the
multi-disciplinary team required by paragraph (Q) of this rule, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation. This
can be the same individual.
(P)
Each freestanding
children's hospital with a level IV neonatal care service and a level III
obstetrical service shall ensure every newborn requiring mechanical ventilation
or continuous positive airway pressure has an initial evaluation by a physician
or certified nurse practitioner (neonatal). If stable, qualified staff with
experience in newborn airway management and diagnosis and management of air
leaks must be on-site to care for such newborns.
(Q)
In addition to
the requirements of paragraph (J) of rule
3701-7-11 of the Administrative
Code, each freestanding children's hospital with a level IV neonatal care
service and a level III obstetrical service shall have on-duty, qualified staff
appropriate for the services provided including at minimum:
(1)
Registered nurse
staffing, including:
(a)
At least two registered nurses competent in obstetric
and neonatal care for labor and delivery;
(b)
A registered
nurse with obstetric and neonatal experience for each patient in the second
stage of labor;
(c)
A registered nurse to circulate for the cesarean
section deliveries; and
(d)
Additional registered nurses with the appropriate
education and demonstrated competence, commensurate with the acuity and volume
of patients served, to provide direct supervision of obstetric
patients;
(2)
At least one member of the nursing staff to attend to
newborns when they are not with the mother or her designee;
and;
(3)
A multi-disciplinary team, each of whom have
successfully completed the neonatal resuscitation program and can initiate
resuscitation. One member of the multi-disciplinary team shall be able to
complete full resuscitation.
