Current through all regulations passed and filed through September 16, 2024
(A)
Obstetric
license. A level IV 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;
(5)
Patients with the
most complex medical conditions as identified by the service, or patients who
are critically ill, including patients with:
(a)
Severe maternal
cardiac conditions;
(b)
Severe pulmonary hypertension or liver
failure;
(c)
Pregnant women requiring neurosurgery or cardiac
surgery; and
(d)
Pregnant women in unstable condition and in need of an
organ transplant;
(6)
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;
(7)
The management of
unanticipated complications of labor and delivery; and
(8)
The management of
emergencies.
(B)
A level IV neonatal care service must be located in a
hospital or other institution and 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 newborns;
(4)
Newborns requiring advanced respiratory care, including
extracorporeal membrane oxygenation; and
(5)
Newborns
requiring major newborn surgery, including surgical repair of serious
congenital malformations that require cardiac bypass.
(C)
A
level IV obstetrical service may admit:
(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;
(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)
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 complex medical conditions and critical illnesses
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 complex delivery receive training in the neonatal resuscitation
program;
(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 or referral for
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 or
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 refer 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.
(E)
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 (D) of this rule.
(F)
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.
(G)
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.
(H)
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.
(I)
Unit management:
Each provider shall have qualified individuals on-staff appropriate for the
services provided, including:
(1)
A board-certified maternal-fetal medicine subspecialist
or 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 obstetric care
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 care 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 certified by the
American college of medical 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.
(J)
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.
(K)
Sub-specialists. Each provider shall have, either
on-site or at a nearby closely related hospital or institution qualified
subspecialists 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;
(c)
Otolaryngologic
surgeons;
(d)
Cardiovascular surgeons;
(e)
Neurosurgeons;
and
(f)
Anesthesiologists.
(L)
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.
(M)
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 (P) of this rule, one of whom can initiate resuscitation, and one of
whom can complete full resuscitation. This can be the same
individual.
(N)
For every delivery with more complex maternal or fetal
conditions, delivery of the most complex medical conditions, or delivery of
critically ill patients, 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 (P) of this rule, one of whom can
initiate resuscitation, and one of whom can complete full resuscitation. This
can be the same individual.
(O)
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.
(P)
Each provider
shall have qualified staff on-duty for direct care of patients, 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 cesarean
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.
(Q)
Other disciplines. Each provider shall have the
following practitioners on-staff:
(1)
A licensed social worker to provide psychosocial
assessments, family support services, and medical social work. 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