Current through all regulations passed and filed through September 16, 2024
(A)
Obstetric
license. A level II 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)
Selected high-risk patients as identified by the
service, such as patients with:
(a)
Severe preeclampsia; or
(b)
Placenta previa
with prior uterine surgery in which a placenta accreta has been ruled out by
ultrasound or magnetic resonance imaging;
(4)
The management of
unanticipated complications of labor and delivery; and
(5)
The management of
emergencies.
(B)
Obstetric transfer. A level II obstetrical service
shall transfer to a level III or level IV obstetric service, as appropriate, of
any pregnant woman for intrapartum care:
(1)
With a high-risk
condition beyond those designated by the service; or
(2)
At less than
thirty-two weeks gestation or with a fetus expected to weigh less than one
thousand five hundred grams.
Exception: A level II 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 less than thirty two 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, complicated, and high-risk
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 II neonatal care service
shall provide intermediate and routine care to newborns, including to:
(1)
All low-risk
newborns;
(2)
All uncomplicated newborns;
(3)
Newborns with
selected complicated conditions as identified by the service, such as
newborns:
(a)
With physiologic immaturity such as apnea of prematurity;
(b)
With an inability
to maintain body temperature;
(c)
With an inability
to take oral feedings;
(d)
Who are moderately ill with problems that are expected
to resolve rapidly and are not anticipated to need sub-specialty services on an
urgent basis; and
(e)
Who are convalescing from intensive
care;
(4)
Newborns requiring mechanical ventilation for brief
durations of less than twenty-four hours or continuous positive airway
pressure, except the twenty-four hour period may be extended if the newborn is
stable and improving, and the newborn does not require numerous interventions
for time periods nearing twenty-four hours over the course of days; and
(5)
Newborns requiring emergency resuscitation or stabilization for
transport.
(E)
Newborn transfer. When a level II obstetrical service
cannot effect a timely transfer of a pregnant woman pursuant to paragraph
(B)(2) of this rule, the level II neonatal care service shall transfer a
newborn that is less than thirty-two weeks gestation or weighs less than one
thousand five hundred grams to a neonatal care service licensed to provide the
needed care unless all of the following conditions are met:
(1)
The level II
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 II neonatal care
service attending physician and a neonatologist on the staff of that 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 II
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 II 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 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
based on the "Guidelines for perinatal care" or other applicable professional
standard and address, at minimum:
(1)
The selected high-risk 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 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 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 or referral of both obstetric and
neonatal transports;
(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 II gestational age
and weight restrictions, based on demonstrated capability to provide the
appropriate services;
(21)
Consultation for maternal-fetal medicine on a
twenty-four hour basis; and
(22)
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;
(2)
Blood, blood
products, and substitutes;
(3)
Diagnostic
imaging limited to x-ray;
(4)
Portable ultrasound visualization equipment for
diagnosis and evaluation; and
(5)
Respiratory
therapy and pulmonary.
(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)
Computed tomography;
(b)
Magnetic
resonance imaging; and
(c)
Fluoroscopy;
(2)
Pharmacy;
(3)
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; and
(4)
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 pediatrician as co-directors of the
obstetric and neonatal care service. The co-directors shall establish
procedures for patients and shall integrate and coordinate a system for
consultation, in-service education and communication with referring obstetric
and neonatal care services;
(2)
A neonatologist
or a pediatrician in consultation with an on-staff neonatologist, to manage the
care of newborns and to provide for:
(a)
A system for consultation and referral;
(b)
Continuing
education programs;
(c)
Communication and coordination with the obstetrical
service; and
(d)
Defining and establishing appropriate policies,
protocols, and procedures for the unit nursery or nurseries and neonatal
follow-up as may be indicated;
(3)
A director of
anesthesia services who is a board eligible or board certified
anesthesiologist;
(4)
A single, designated, full-time registered nurse with a
bachelor's degree in nursing with demonstrated expertise in obstetric care, or
neonatal care, or both responsible for leading the organization and supervising
of nursing services in the neonatal care service and the obstetrical
service.
(5)
A registered nurse to provide clinical perinatal
nursing expertise commensurate with the patient acuity and services provided.
Expertise may be demonstrated through education, certification or a minimum of
five years perinatal experience;
(N)
Specialists. Each
provider shall have medical, surgical, radiological and pathology specialists
on-call based upon the medical needs of the patients.
(O)
Sub-specialists.
Each provider shall have a maternal-fetal medicine sub-specialist available for
consultation.
(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 acting within their scope of practice and under a standard
care arrangement with a collaborating physician 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 (S) of this rule, one of whom can initiate resuscitation, and one of
whom can complete full resuscitation. This can be the same
individual.
(R)
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.
(S)
Each provider shall have qualified staff on-duty
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;
(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 capable of completing full
resuscitation.
(T)
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.
Replaces: Part of 3701-7-07, Part of 3701-7-08, and
3701-7-10
