Current through all regulations passed and filed through September 16, 2024
(A)
Obstetric
license. 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 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)
Neonatal license.
A level III neonatal care service shall provide intensive, intermediate and
routine care to newborns, including to:
(1)
All low risk
newborns;
(2)
All complicated newborns;
(3)
Extremely low
birth weight infants;
(4)
Newborns requiring advanced respiratory care, other
than extracorporeal membrane oxygenation, including high-frequency ventilation
and inhaled nitric oxide. This paragraph notwithstanding, a level III neonatal
care service that was providing pulmonary extracorporeal membrane oxygenation
that did not require cardiac intervention under rule
3701-7-11 of the Administrative
Code as it existed prior to the effective date of this rule may continue to
provide extracorporeal membrane oxygenation that does not require cardiac
intervention;
(5)
Newborns requiring major surgery as identified by the
service, other than newborns requiring immediate surgical repair of serious
congenital cardiac malformations that require cardiopulmonary bypass, as
designated by the service, either on-site or at a nearby, closely-related
institution; and
(6)
Newborns that require emergency resuscitation or
stabilization for transport.
(E)
Newborn
transfers. When a level III obstetrical service cannot timely transfer a
pregnant woman pursuant to paragraph (B)(2) of this rule, the level III
neonatal care service shall transfer a newborn to a level IV neonatal care
service if the newborn is anticipated to need advanced medical or surgical care
beyond that which the transferring service is licensed to provide, unless all
of the following are met:
(1)
The level III neonatal care service has in place a
valid memorandum of agreement with one or more level IV neonatal care services,
providing for consultation on the retention of the infant between the level III
neonatal care service attending physician and the neonatologist on the staff of
the level IV neonatal care service;
(2)
The consultation
with, and the concurrence of, the neonatologist on the staff of the level IV
neonatal care service is documented by the level III neonatal care service in
the patient medical record and as otherwise may be determined by the service;
and
(3)
The risks and benefits to the newborn for both
retention at the level III neonatal care service and transfer of the newborn to
a level IV neonatal care service are discussed with the parent, parents, or
legal guardian of the newborn and appropriately documented.
(F)
Informed consent. When discussing transfer of a pregnant woman or a newborn 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 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.
(G)
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.
(H)
Written service plan. Each provider shall, using
licensed health care professionals acting within their scopes of practice,
develop a written service plan for the care and services to be provided by the
service. The written service plan shall be in accordance with the "Guidelines
for perinatal care" or other applicable professional standard and address, at
minimum:
(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)
Patient care in
accordance with accepted professional standards;
(6)
Referrals for
obtaining public health, dietetic, genetic, and toxicology services not
available in-house;
(7)
Minimum competency requirements for staff in accordance
with recognized national standards and ensure that all staff are competent to
perform services based on education, experience and demonstrated
ability;
(8)
Administration of blood and blood
products;
(9)
Provision of phototherapy;
(10)
Provision of
respiratory therapy;
(11)
Unit-based surgeries and surgical suite-based
surgeries;
(12)
Post-mortem care;
(13)
A formal
education program for staff including, at minimum:
(a)
The neonatal
resuscitation program. The service shall ensure all labor and delivery
registered nurses and any other practitioner likely to attend to a neonate at a
high risk or more complicated delivery receive training in the neonatal
resuscitation program; and
(b)
A post-
resuscitation program. The service shall ensure individuals caring for newborns
receive training in a post resuscitation program to include, at minimum:
(i)
The
identification and treatment of signs and symptoms related to hypoglycemia,
hypothermia, and pneumothorax;
(ii)
Blood pressure
(normal ranges, factors that can impair cardiac output);
(iii)
Lab work,
including perinatal and postnatal risks factors and clinical signs of
sepsis;
(iv)
Principles of assisted ventilation, continuous positive
airway pressure, positive pressure ventilation, assisting and securing
endo-tracheal tube insertion, and chest x-rays;
(v)
Emotional support
to parents with sick infants; and
(vi)
Quality
improvement to identify problems and the importance of debriefing to evaluate
care in the post-resuscitation period; and
(c)
Ongoing
continuing education;
(14)
Provision of
care by direct care staff to individuals in other areas of the hospital,
including, but not limited to the emergency department and the intensive care
unit;
(15)
Risk assessment of obstetric and neonatal patients to
ensure identification of appropriate consultation requirements for or referral
of high-risk patients;
(16)
Follow-up services to patients or refer patients for
appropriate follow-up;
(17)
Education for mothers regarding personal care and
nutrition, newborn care and nutrition, and newborn feeding;
(18)
Infection
control, consistent with current infection control guidelines issued by the
United States centers for disease control and prevention;
(19)
Consultation for
and referral of both obstetric and neonatal transports;
(20)
The coordination
and facilitation, on a twenty-four hour basis, of both obstetric and neonatal
transports, which may include the reverse transport of
newborns;
(21)
Consultation for maternal-fetal medicine on a
twenty-four hour basis;
(22)
Developmental follow-up of at-risk newborns in the
service or referral of such newborns to appropriate programs;
(23)
Continuing
education for referring hospitals;
(24)
Provision of
opportunities for graduate medical education such as pediatric or
obstetrics-gynecology residencies and neonatal or maternal-fetal medicine
fellowships;
(25)
Provision of opportunities for clinical experience for
purposes of graduate nursing education, or continuing education, or
both;
(26)
Participation, on an ongoing basis, in basic or
clinical obstetrics or neonatology research; and
(27)
Provision of
multi-disciplinary planning relating to management and therapy through the
postpartum period.
(I)
Each provider
shall, in accordance with accepted professional standards, develop and follow
written policies and procedures to implement the written service plan required
by paragraph (H) of this rule.
(J)
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.
(K)
Support services (on-site). Each provider shall have
the following staff and services on-site on a twenty-four hour basis:
(1)
Clinical
laboratory, capable of providing any necessary testing;
(2)
Blood, blood
products, and substitutes;
(3)
Diagnostic
imaging, including:
(a)
X-ray; and
(b)
Computed
tomography;
(4)
Portable ultrasound visualization equipment for
diagnosis and evaluation;
(5)
Pharmacy;
(6)
Respiratory
therapy and pulmonary; and
(7)
Anesthesia.
(L)
Support services (on-call). On a twenty four hour
basis, each provider shall have the following services on-site, with staff
necessary to provide the services on-call:
(1)
Diagnostic
imaging, including:
(a)
Magnetic resonance imaging;
(b)
Fluoroscopy;
and
(c)
Echocardiography; and
(2)
Biomedical
engineering.
(M)
Unit management: Each provider shall have qualified
individuals on-staff appropriate for the services provided, including:
(1)
A board-certified
obstetrician and a board-certified neonatologist as co-directors for the
obstetric and neonatal care service. The co-directors shall coordinate and
integrate the following:
(a)
A system for consultation;
(b)
In-service
education programs;
(c)
Coordination and communication with support services
and other obstetrical services;
(d)
Defining and
establishing, in collaboration with other members of the obstetric team,
appropriate protocols and procedures for obstetric patients;
and
(e)
Treatment of patients in the neonatal intensive care
unit who are not under the care of other physicians;
(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 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 neonatal care service;
(5)
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;
(6)
A director of
obstetric anesthesia services who is a board-eligible or board-certified
anesthesiologist;
(7)
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.
(N)
Specialists. Each
provider shall have medical, surgical, radiological and pathology specialists
either on-site or on-call based on the medical needs of the
patients.
(O)
Sub-specialists. Each provider shall have qualified
sub-specialists available for consultation, and, if necessary, 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:
(1)
Medical-surgical:
(a)
Maternal-fetal
medicine;
(b)
Critical care;
(c)
General
surgery;
(d)
Infectious disease;
(e)
Hematology;
(f)
Cardiology;
(g)
Nephrology; and
(h) Neurology;
(2)
Pediatric:
(a)
Hematology;
(b)
Nephrology
(c)
Metabolic;
(d)
Endocrinology;
(e)
Gastroenterology;
(f)
Nutrition;
(g)
Immunology;
and
(h)
Pharmacology; and
(3)
Pediatric
surgical:
(a)
Orthopedic surgeons;
(b)
Urologic surgeons; and
(c)
Otolaryngologic
surgeons.
(P)
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 to care for the neonate.
(Q)
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 (T) of this rule, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation. This
can be the same individual.
(R)
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 (T) of this rule, one of whom can initiate resuscitation, and one of
whom can complete full resuscitation. This can be the same
individual.
(S)
Each provider 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.
(T)
Each provider 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;
(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 newborns;
and
(e)
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;
and
(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 can initiate resuscitation. One member of the multi-disciplinary
team shall be capable of completing full resuscitation.
(U)
Other
disciplines. Each provider shall have the following practitioners
on-staff:
(1)
A
licensed social worker to provide psychosocial assessments and family support
services. Additional social workers shall be provided based upon the size and
needs of the patient population;
(2)
A licensed
dietitian with knowledge of maternal and newborn nutrition and knowledge of
parenteral/enteral nutrition management of at-risk newborns;
and
(3)
A certified lactation consultant. Additional certified
lactation consultants shall be provided based upon the size and needs of the
patient population.
Replaces: Part of 3701-7-07, Part of 3701-7-08, and Part of
3701-7-11
