Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 130.000 - Hospital Licensure
Subpart D - SUPPLEMENTARY STANDARDS: PARTICULAR SERVICES
Section 130.640 - Level IIA and IIIB: Community-based Maternal and Newborn Service with a Special Care Nursery
Universal Citation: 105 CMR 130.000 MA Code of Regs 130.640
Current through Register 1531, September 27, 2024
(A) Level IIA Service. Level IIA capabilities include the management of pregnancies of 34 weeks gestation or greater, and the management of pregnancy complications not requiring the facilities and resources of Level IIB or Level III services. Level IIA capabilities include the care and management of the stable to moderately ill newborn, well newborns, premature infants and infants who require special care services (including retro-transferred infants).
A service shall be eligible to apply for designation as a Level IIA service with a special care nursery if one of the following conditions is met:
(1) the service has
a minimum of 1,500 births per year in any one of the past three years prior to
the initiation of the service designation request; or
(2) the service has satisfactorily
demonstrated to the Department that a minimum volume of 1,500 births per year
will be reached in the next three years; or
(3) the service has satisfactorily
demonstrated to the Department that the hospital meets Level IIA quality and
competency requirements and therefore the designation is warranted. Following
the designation, a Level IIA service shall maintain a minimum volume of 1,500
births.
(B) Level IIB Service. Level IIB capabilities include the care and management of pregnancies of 32 weeks gestation or greater, and the management of pregnancy complications not requiring the facilities and resources a Level III service. Level IIB capabilities include the care and management of the stable to moderately ill newborn, well newborns, premature infants and infants who require special care services (including retro-transferred infants). Level IIB service includes the care of infants requiring Continuous Positive Airway Pressure (CPAP), in compliance with guidelines established by the Department.
A service shall be eligible to apply for designation as a Level IIB service with special care nursery if one of the following conditions is met:
(1) the service has a minimum
of 2,000 births per year in any one of the past three years prior to the
initiation of the service designation request; or
(2) the service has a minimum volume of 2,500
births for each of the two years after the designation as a Level IIA services;
or
(3) the service has
satisfactorily demonstrated to the Department that the hospital meets Level IIB
quality and competency requirements and therefore the designation is warranted.
Following the designation, a Level IIB service shall maintain a minimum volume
of 2,000 births.
(C) The Level IIA or IIB Community-based Maternal-Newborn Service shall meet the requirements of a Level I service and those requirements contained in 105 CMR 130.601 through 130.630 and 130.640(D) through (E), unless otherwise specified.
(D) Maternal Service.
(1)
Administration and Staffing.
(a)
Nursing.
1. The hospital shall designate a registered
nurse who has responsibility and accountability for the 24 hour nursing
management of the Level II service. At a minimum, such nurse shall be prepared
at the baccalaureate level and have additional education in the specialty area.
She or he shall also have at least two years experience in the specialty area
and meet the qualifications for the management position as defined by hospital
policy.
2. In a Level IIA service,
a registered nurse educator, prepared at the baccalaureate level (master's
preferred) shall have dedicated responsibility for coordinating and providing
education activities to enhance staff knowledge of relevant procedures and
technological advances for staff of the maternal and newborn service.
3. In a Level IIB service, at a minimum a
full time master's prepared clinical nurse educator, preferably a specialist
with clinical experience in perinatology or neonatology or a neonatal nurse
practitioner shall be available with dedicated responsibility for coordinating
education for maternal and newborn staff.
(b) A licensed social worker with experience
in maternal and child health shall be available to provide services to mothers
and families.
(2)
Services. Each Level II Maternal Service shall provide
the following:
(a) Radiology, in-house, 24
hours a day.
(b) Clinical
laboratory services including microchemical fetal blood sample monitoring, in
house, 24 hours a day.
(c)
Ultrasound and amniocentesis services in-house, 24 hours a day.
(d) Specialty services for the mothers
including, but not limited to, general surgery, cardiology, urology, internal
medicine, hematology and neurology.
(e) Access to genetics counseling.
(3)
Policies and
Procedures. Each Level II Maternal Service shall have written
policies and procedures as required by
105 CMR
130.601 through
130.628
and, in addition, the following:
(a) n
organized plan for a team approach to deliveries that requires the presence of
a pediatrician and an anesthesiologist in the delivery room and properly
defines their responsibilities. The hospital's perinatal committee shall
establish policies, definitions, and conditions of delivery requiring a team
approach.
(b) Other policies and
procedures as deemed appropriate by the hospital perinatal committee. Such
policies shall be submitted to the Department upon request.
(E) Special Care Nursery.
(1)
Administration and Staffing.
(a) A neonatologist certified by the American
Board of Pediatrics in neonatology shall be designated the medical director of
the Special Care Nursery. A pediatrician meeting the requirements of 105 CMR
130.640(E)(1)(b) shall be designated to act in the absence of the
director.
(b) A neonatologist
certification in neonatology by the American Board of Pediatrics shall be
available on-call 24 hours a day.
(c) The hospital shall designate a registered
nurse who has responsibility and accountability for the 24 hour nursing
management of the Special Care Nursery service. At a minimum, such nurse shall
be baccalaureate-prepared and have additional education in the neonatology
specialty area. She or he shall have at least two years experience in the
specialty area and meet the qualifications for the management position as
defined by hospital policy.
(2)
Special On-site Staffing
Requirements. Each hospital providing special care nursery
services shall provide on-site coverage 24 hours a day by either a
neonatologist, pediatrician or a physician who meets the requirements of 105
CMR 130.640(E)(2)(a) or neonatal nurse practitioner who meets the requirements
of 105 CMR 130.640(E)(2)(b), who shall be immediately available to the special
care nursery and the delivery room.
(a)
Pediatricians. A pediatrician qualified to provide
on-site coverage in the special care nursery shall be either a pediatric
resident who, at a minimum, has completed the second year of post-graduate
residency training with at least two months neonatal intensive care unit
rotations or a pediatrician. Pediatricians shall meet the hospital's
requirements for special care nursery privileges. Pediatric residents shall
meet criteria for special care nursery coverage established by the Director of
the special care nursery. At a minimum, criteria for privileges and coverage
shall include the specific clinical skills to provide emergency newborn
resuscitation in the delivery room and essential special care nursery skills
such as intubation, emergency pneumothorax management, umbilical artery
catheterization, and drawing arterial blood gases. Before assignment to provide
on-site coverage, pediatricians and residents shall successfully complete the
American Heart Association/American Academy of Pediatrics neonatal
resuscitation course (or an equivalent).
(b)
Neonatal Nurse
Practitioner.
1. A neonatal nurse
practitioner qualified to provide on-site coverage in the special care nursery
shall:
a. be certified as a neonatal nurse
practitioner by a nationally recognized organization; and
b. be authorized to practice as an advanced
practice registered nurse by the Massachusetts Board of Registration in
Nursing.
2. Before
assignment to provide on-site coverage, each neonatal nurse practitioner shall
successfully complete the American Heart Association/ American Academy of
Pediatrics neonatal resuscitation course (or an equivalent).
3. Neonatal nurse practitioners shall be
credentialed through the hospital's nursing department and medical staff. The
neonatal nurse practitioner shall engage in prescriptive practice in accordance
with written guidelines mutually developed and agreed upon between the nurse
practitioner and the physician supervising the nurse practitioner's
prescriptive practice. The written guidelines will conform to
244
CMR 4.07(2)(b). Neonatal
nurse practitioners shall also meet the criteria for delivery room and special
care nursery coverage established by the director of the special care nursery.
Criteria shall include the skills necessary to provide emergency care to
newborns as outlined in 105 CMR 130.640(E)(3)(a).
4. The nurse practitioner providing Level II
coverage shall have at least one year's recent experience functioning as a
neonatal nurse practitioner on a service that provides high risk obstetrical
and neonatal intensive care unit services.
5. Neonatal nurse practitioners shall be part
of a team providing patient care and not retained only to provide off hour or
holiday coverage at the level II service. The schedule for coverage of the
delivery room and special care nursery shall reflect that pediatricians and
neonatal nurse practitioners who are members of the team share responsibility
for covering all shifts and collaborate in the ongoing care of infants and
their families and in professional education activities.
6. There shall be written policies and
procedures outlining the specific criteria for summoning pediatrician or
neonatologist back-up coverage for consultation and for on-site assistance in
the delivery room and special care nursery.
(3)
Services. Each
Level IIA or IIB Special Care Nursery shall provide the following, unless
otherwise specified:
(a) Provision of a
neutral-thermal environment.
(b)
Continuous and long-term oxygen administration via nasal
cannula and hood, including oxygen saturation monitoring.
(c) Pharmacological treatment of apnea of
prematurity.
(d) Capabilities to
insert and maintain intravenous therapy for hydration and medication
administration, in house, 24 hours a day.
(e) Umbilical artery and venous catheter
insertion and maintenance.
(f)
Continuous electronic cardio-respiratory monitoring.
(g) Blood transfusion capability (exchange
transfusion optional).
(h)
Naso-gastric, oro-gastric and oro-jejunal feedings.
(i) Parenteral nutrition.
(j) Access within the facility or through
arrangement with Level III facilities to subspecialty services or consultation
with pediatric surgery, neurology, cardiology and genetics.
(k) CPAP services in compliance with
guidelines established by the Department.
(4)
Policies and Procedures for
Transfer.
(a) In a Level IIA
service a mechanical ventilator or CPAP may be initiated and used in a Special
Care Nursery prior to a transfer to a Level III service when the Medical
Director of the Special Care Nursery approves such use and when all of the
following conditions are met:
1. A
neonatologist remains immediately available in the hospital at all
times.
2. A respiratory therapist
with experience in neonatal ventilation remains at the infant's bedside at all
times.
3. The Special Care Nursery
is arranging for transport of the infant to the Level III service.
4. The mechanical ventilator is used only
while the infant is awaiting the transport.
(b) In a Level IIB service a mechanical
ventilator may be initiated and used in a Special Care Nursery prior to a
transfer to a Level III service when the Medical Director of the Special Care
Nursery approves such use and when all of the following conditions are met:
1. A neonatologist remains immediately
available in the hospital at all times.
2. A respiratory therapist with experience in
neonatal ventilation remains at the infant's bedside at all times.
3. The Special Care Nursery is arranging for
transport of the infant to the Level III service.
4. The mechanical ventilator is used only
while the infant is awaiting the transport.
(5)
Other Policies and
Procedures. The Special Care Nursery shall have written policies
and procedures for the following:
(a)
Orientation and ongoing education for registered nurses including the
theoretical framework and skills required to practice in the Special Care
Nursery.
(b) Other policies and
procedures as deemed appropriate by the hospital perinatal
committee.
(6)
Records. In addition to meeting the requirements for
records contained in
105 CMR
130.627(B), the record of a
newborn treated in a Special Care Nursery shall also contain documentation of
the following:
(a) Diagnostic and treatment
modalities.
(b) Family-infant
interactions.
(c) Parents'
understanding of infant's condition, progress and treatment.
(d) Parent education and involvement in both
normal and specialized care-giving.
(e) Where indicated, the plan for and patient
response to infant stimulation program.
(f) Referrals to community agencies such as
parent support groups, visiting nurse associations and early intervention
programs.
(7)
Environment and Equipment. The Special Care Nursery
shall contain, at a minimum, the following equipment and be responsible for
appropriate maintenance, per hospital policy:
(a) Incubators.
(b) Cardio-respiratory monitors with high/low
alarm.
(c) Warming
table(s).
(d) Infusion
pumps.
(e) Oxygen humidification
and warming system.
(f) Oxygen
analyzer.
(g) Umbilical artery/vein
catheterization equipment.
(h)
Neonatal resuscitation medications and equipment as described by the American
Academy of Pediatrics Neonatal Resuscitation Program guidelines.
(8)
Construction and
Arrangement of Special Care Nursery. The construction and
arrangement of the Special Care Nursery shall permit immediate observation and
accessibility of infants to personnel. Total nursery space, exclusive of
anteroom, shall provide an average floor space of 50 square feet for each
incubator or bassinet.
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