Current through all regulations passed and filed through September 16, 2024
(A)
Obstetric
license. A level I obstetrical service shall provide antepartum, intrapartum
and postpartum care for obstetrical patients, including:
(1)
Low-risk
patients, such as patients with:
(a)
Term deliveries;
(b)
Singleton
deliveries; and
(c)
Deliveries with vertex presentation;
(2)
Selected uncomplicated patients with higher-risk conditions,
such as patients with:
(a)
Term twin gestation;
(b)
Trial of labor
after cesarean delivery;
(c)
Uncomplicated cesarean delivery; or
(d)
Preeclampsia
without severe features at term;
(3)
The management of
unanticipated complications of labor and delivery; and
(4)
The management of
emergencies.
(B)
Obstetric transfers. A level I obstetrical service
shall transfer to a level II, level III, or level IV obstetric service, as
appropriate, any pregnant woman for intrapartum care:
(1)
With a
complicated condition beyond those designated by the service;
or
(2)
At less than thirty-five weeks of her pregnancy.
Exception: A level I 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 evidenced by the
following:
(a)
The mother is having contractions; and
(b)
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 less than thirty-five weeks gestation 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 with uncomplicated and complicated conditions for
antepartum care 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 I neonatal care service shall
provide care to newborns, including to:
(1)
All low-risk
newborns;
(2)
Newborns with selected complicated conditions as
identified by the service, such as newborns who are:
(a)
Moderately ill
with problems that are expected to resolve rapidly and are not anticipated to
need specialty or subspecialty services on an urgent basis; and
(b)
Convalescing that
can be appropriately transferred from another service provider;
and
(3)
Newborns requiring emergency resuscitation or
stabilization for transport.
(E)
Newborn
transfers. When a level I obstetrical service cannot timely transfer a pregnant
woman pursuant to paragraph (B)(2) of this rule, the level I neonatal care
service shall transfer a newborn that is less than thirty five weeks gestation
to a neonatal care service or freestanding children's hospital licensed to
provide the needed care, unless all of the following conditions are met:
(1)
The level I
neonatal care service has in place a valid memorandum of agreement with one or
more neonatal care services licensed to provide the needed care, providing for
consultation on the retention of the infant between the level I neonatal care
service attending physician and a neonatologist on the staff of the neonatal
care service licensed to provide the needed care;
(2)
The consultation
with, and the concurrence of, the neonatologist on the staff of the neonatal
care service licensed to provide the needed care is documented by the level I
neonatal care service in the patient medical record and as otherwise may be
determined by the service. Such documentation shall be made available to the
director upon request; and
(3)
The risks and
benefits to the newborn for both retention at the level I neonatal care service
and transfer of the newborn to a neonatal care service licensed to provide the
needed care, are discussed with the parent, parents, or legal guardian of the
newborn and appropriately documented. Such documentation shall be made
available to the director upon request.
(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 higher-level
service;
(2)
The risks and benefits associated with with the
patient's transfer or retention; and
(3)
Any other
information required by the hospitals' 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
based on the "Guidelines for perinatal care" or other applicable professional
standard and address, at minimum:
(1)
The selected uncomplicated conditions for which 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 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 risk factors and clinical signs of
sepsis;
(iv)
Emotional support to parents with sick infants;
and
(v)
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 newborn patients to ensure identification of appropriate
consultation requirements for or referral of high-risk
patients;
(16)
Follow-up services to patients or the referral of
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; and
(20)
Criteria for the acceptance of both obstetric and
neonatal transports from other services, which may include the reverse
transport of newborns who otherwise do not meet the level I gestational age
restriction, based on demonstrated capability to provide the appropriate
services;
(21)
Developmental follow-up of at-risk newborns in the
service or referral of such newborns to appropriate programs.
(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 staff and support services to meet the needs of patients and have the
following staff and services on-site on a twenty-four hour basis:
(1)
Clinical
laboratory capable of providing any necessary testing; and
(2)
Blood, blood
products and substitutes.
(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 x-ray
capable of providing portable x-ray services;
(2)
Portable
ultrasound visualization equipment for diagnosis and
evaluation;
(3)
Pharmacy; and
(4)
Anesthesia,
except that when a patient or patients are receiving a labor epidural, an
anesthesiologist or certified registered nurse anesthetist acting within their
scope of practice and under the supervision of a physician, shall remain in
attendance with a patient until it is determined the patient is stable, but for
at least thirty minutes. After it is determined the patient is stable, an
anesthesiologist or certified registered nurse anesthetist may be on-call, but
shall remain available to return in accordance with facility policy, but no
longer than thirty minutes.
(M)
Unit management.
Each provider shall have qualified individuals on-staff appropriate for the
services provided including:
(1)
Co-directors of the obstetric and neonatal care service
responsible for the overall operation of the respective care service;
(a)
One co-director
shall be a board certified obstetrician or board certified family physician
with experience in obstetrics; and
(b)
One co-director
shall be a board certified pediatrician or a board certified family physician
with experience in pediatrics; and
(2)
A single,
dedicated registered nurse with a bachelor's degree in nursing, responsible for
leading the organization and supervision of nursing services in the obstetric
and newborn care services. Individuals employed in this position prior to the
effective date of this rule who remain in this position do not need to comply
with the degree requirement.
(N)
For every
anticipated low risk delivery or uncomplicated delivery with higher-risk
condition, each provider shall have an:
(1)
Obstetrician,
physician, or certified nurse midwife acting within their scope of practice and
under a standard care arrangement with a collaborating physician, in
attendance; and
(2)
Individual who has successfully completed the neonatal
resuscitation program and who can initiate and complete full resuscitation
on-site. This requirement may be met by a team of individuals who have
successfully completed the neonatal resuscitation program, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation.
For an unanticipated delivery of a
high-risk delivery as that term is used in paragraph (A)(3) of rule
3701-7-08 of the Administrative
Code, 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.
(O)
For every
anticipated high-risk delivery as that term is used in paragraph (A)(3) of rule
3701-7-08 of the Administrative
Code, each provider shall have in attendance:
(1)
An obstetrician
or physician;
(2)
A physician or certified nurse practitioner with
demonstrated expertise in neonatal care, to care for the neonate;
and
(3)
An individual who has successfully completed the
neonatal resuscitation program and who can initiate and complete full
resuscitation. This requirement may be met by a team of individuals who have
successfully completed the neonatal resuscitation program, one of whom can
initiate resuscitation, and one of whom can complete full
resuscitation.
(P)
Each provider shall have qualified staff on-duty
appropriate for the services provided including, at minimum:
(1)
Registered nurse
staffing to include:
(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 birth
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 obstetric patients;
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 newborns;
and
(2)
At least one member of the nursing staff to attend to
newborns when they are not with the mother or her designee.
(Q)
Other
disciplines. Each provider shall have the following practitioners
on-staff:
(1)
A
licensed social worker with knowledge of obstetric and neonatal psychosocial
and family support services;
(2)
A licensed
dietitian; and
(3)
A certified lactation consultant.
Replaces: Part of 3701-7-07, Part of 3701-7-08, and Part of
3701-7-09
