Ohio Administrative Code|Rule 3701-7-08 | Level II service standards.

                                                

(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 practitioners 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.

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