Current through all regulations passed and filed through September 16, 2024
(A)
A freestanding
children's hospital with a level III neonatal care service shall provide care
for for newborns, including:
(1)
Low-risk newborns;
(2)
Convalescing and
moderately ill newborns;
(3)
Extremely low birth weight infants;
(4)
Newborns who
require advanced respiratory care, other than extracorporeal membrane
oxygenation, such as high-frequency ventilation and inhaled nitric oxide;
and
(5)
Newborns who require major surgery other than surgical
repair of serious congenital cardiac malformations that require cardiopulmonary
bypass.
(B)
A freestanding children's hospital with a level IV
neonatal care service shall provide care for for newborns and fetuses,
including:
(1)
Low-risk newborns;
(2)
Convalescing and moderately ill
newborns;
(3)
Extremely low birth weight infants;
(4)
Newborns who
require advanced respiratory care, including extracorporeal membrane
oxygenation;
(5)
Newborns who require major surgery, such as surgical
repair of serious congenital cardiac malformations that require cardiopulmonary
bypass;
(6)
Newborns at extreme high-risk;
(7)
Newborns
receiving specialized services such as:
(a)
Cardiac
surgery;
(b)
Organ transplants; or
(c)
Treatments of
rare inborn metabolic errors.
(C)
Written service
plan. Each freestanding children's hospital with a level III or level IV
neonatal care service shall, using licensed health care professionals acting
within the scopes of their practice, develop a written service plan for the
care and services to be provided. The written service plan shall be based on
the "Guidelines for perinatal care" and address, at minimum:
(1)
The specialized
services provided by the service 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 unit;
(4)
Discharge from
the unit;
(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)
Provision of a
formal education program for staff that includes, at minimum:
(a)
The neonatal
resuscitation program. The service shall ensure all labor and delivery
registered nurses and any other practitioner likely to attend a high risk
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
direct care staff to provide care 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 neonatal patients to ensure
identification of appropriate consultation requirements or referral of
high-risk patients;
(16)
Follow-up services to patients or refer patients for
appropriate follow-up;
(17)
Infection control, consistent with current infection
control guidelines issued by the United States centers for disease control and
prevention;
(18)
Consultation or referral of neonatal
transport;
(19)
Coordination and facilitation of neonatal transports
from referring hospitals on a twenty four hour basis;
(20)
Consultation for
neonatal care services on a twenty-four hour basis;
(21)
Developmental
follow-up of at-risk newborns in the service or refer such newborns to
appropriate programs;
(22)
Provision of developmental follow-up of at-risk
newborns in the service or refer such newborns to appropriate
programs;
(23)
Continuing education for referring
hospital;
(24)
Provision of opportunities for graduate medical
education such as pediatric residencies or neonatal medicine
fellowships;
(25)
Provision of opportunities for clinical experience for
purposes of graduate nursing education, or continuing education, or
both;
(26)
Participation in basic or clinical neonatology research
on an ongoing basis; and
(27)
Provision of multidisciplinary planning related to
management and therapy for newborn care.
(D)
Each provider
shall, in accordance with accepted standards of practice, develop and follow
written policies and procedures to implement the written service plan required
by paragraph (C) of this rule.
(E)
Support services.
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.
(F)
On a twenty four hour basis, each provider shall have
the following services on-site, with staff necessary to provide the service
on-call:
(1)
Diagnostic imaging, including:
(a)
Magnetic resonance imaging;
(b)
Fluoroscopy;
and
(c)
Echocardiography; and
(2)
Biomedical
engineering.
(G)
Each provider shall have qualified individuals on-staff
appropriate for the services provided including:
(1)
A board certified
neonatologist as director of the neonatal care service. The director shall
coordinate and integrate the following, including:
(a)
A system for
consultation;
(b)
In-service education programs;
(c)
Coordination and
communication with support services;
(d)
In collaboration
with other members of the neonatal team, define and establish appropriate
protocols and procedures for newborn patients; and
(e)
Treatment of
patients in the neonatal intensive care unit who are not under the care of
other physicians;
(2)
A single,
designated registered nurse with a bachelor's degree in nursing and a master's
degree responsible for leading the organization and supervision of nursing
services in the neonatal care service; and
(3)
A registered
nurse with a master's degree in nursing and an area of specialization in
neonatal health to provide clinical nursing expertise commensurate with the
patient acuity and services provided.
(H)
Specialists.
Medical, surgical, radiological and pathology specialists shall be on-call
based on the medical needs of the patients.
(I)
Sub-specialists.
Each freestanding children's hospital with a level III or level IV neonatal
care service shall have, either on-site or at a nearby closely related hospital
or institution, qualified sub-specialists that may include:
(1)
Pediatric:
(a)
Nephrologists;
(b)
Hematologists;
(c)
Metabologists;
(d)
Endocrinologists;
(e)
Gastroenterologists;
(f)
Nutritionists;
(g)
Infectious
disease;
(h) Pulmonologists;
(i)
Immunologists;
and
(j) Pharmacologists;
(2)
Pediatric
surgical:
(a)
Orthopedic surgeons;
(b)
Urologic surgeons; and
(c)
Otolaryngologic
surgeons; and
(3)
For a freestanding children's hospital with a level IV
neonatal care service, additional pediatric surgical:
(a)
Cardiovascular
surgeons; and
(b)
Neurosurgeons.
(J)
Each provider
shall have sufficient registered nurses with the appropriate education and
demonstrated competence, commensurate with the acuity and volume of patients
served, on-duty at all times to provide direct supervision of
newborns.
(K)
Other disciplines. Each provider shall have the
following practitioners on-staff:
(1)
At least one 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
3701-7-12
