(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.
