Perinatal Designation
Criteria
(excerpted from NYSDOH
Regulations 2003)
[(14)](15) Level I perinatal care [program] service shall mean a comprehensive maternal and newborn service [services program provided by a hospital designated as such by the department for women who have been assessed as having a normal, low-risk pregnancy and having a fetus which has been assessed as developing normally and without apparent complications. A woman at low risk means a woman with a normal, medical surgical and obstetrical history and a normal uncomplicated prenatal course as determined by adequate prenatal care, and prospects for a normal, uncomplicated birth] as defined by Section 721.2(a) of this Title.
[(15)](16) Level II perinatal care [program]service
shall mean a comprehensive maternal and newborn service [services
program provided by a hospital designated as such by the department for women
who have been assessed as having the potential or likelihood for a complicated
or high-risk delivery and/or bearing a fetus exhibiting the potential for
unusual or high-risk development who may require an intermediate or intensive
level of specialized care services. Such programs may also provide services to
women requiring care normally provided at Level I programs] as defined by
Section 721.2(b) of this Title.
[(16)](17) Level III perinatal care[program] service shall mean a comprehensive maternal and newborn service [services program provided by a hospital designated as such by the department, provided by a tertiary care hospital for women who have been assessed as high-risk patients and/or are bearing high-risk fetuses as determined by a standardized risk assessment tool, who will require the highest level of specialized care. Such programs may also provide services to women requiring care normally provided at Level I and II programs] as defined by Section 721.2(c) of this Title.
[(17)](18) Regional perinatal [care]center (“RPC”)
shall mean a [facility]hospital or hospitals housing a Level III
perinatal care [program and designated as such by the department, serving a given
designated region which provides all aspects of maternal and neonatal care and
whose functions and responsibilities also include education, evaluation and
data collection within that region] service as defined in Section 721.2(d)
of this Title.
(19) Perinatal affiliates shall mean Level I,
Level II and Level III hospitals which have a current perinatal affiliation
agreement with a specific RPC as defined in Section 721.11 of this Title.
[(d)](c) High- risk antepartum services at Level II[and], Level III and RPC perinatal [care programs]services.
(1) Level II [and], Level III and RPC perinatal [care programs]services shall develop and implement written policies and procedures to indicate where pregnant patients with obstetric, medical, or surgical complications are to be assigned to provide for their continuous observation and care.
(2) Maternal [special] intensive care services. (i) Hospitals providing Level I or II perinatal care [programs]services shall develop, enter into and implement written agreements with hospitals providing Level III and RPC perinatal care [programs]services for the transfer of obstetric patients whose physical conditions are evaluated as needing such higher level of care.
(ii) Hospitals which provide multiple levels of [maternal special] perinatal care services shall develop and implement written protocols and procedures for the in-house transfer of patients who are evaluated as requiring a level of care other than the level being provided in the area where the patient is currently located.
(iii) Evaluation of the patient's condition and need for [special] intensive care services shall be conducted in accordance with standardized risk assessment criteria based on generally accepted standards of practice which shall be adopted in writing and implemented uniformly throughout the [maternity] perinatal service.
(iv)
[Perinatal care programs.
Hospitals] Level II, Level
III and RPC perinatal care services shall [(a)] maintain a nursing staff
that is appropriately trained and adequate in size to provide specialized care
to distressed mothers and infants. The number of patient care staff on duty
during any shift shall reflect the volume and nature of patient services being
provided during that shift [; and] .
[(b) a regional perinatal care center] (v) An RPC shall:
[(1)](a) offer education and training to [all hospitals] its perinatal affiliates and associated birth centers [in the region which provide maternity and newborn services]. Education and training shall be designed to update and enhance staff knowledge and familiarity with relevant procedures and technological advances;
[(2)](b) review, in conjunction with its perinatal affiliates, all cases of patients transferred to [the regional center] a higher level of care to determine whether such transfers were appropriate and accomplished according to established transfer agreements; and
[(3)](c)
participate in case conferences with [hospitals]its perinatal affiliates
and associated birth centers [in the region] to determine whether any
non-transferred high risk cases
[which resulted in a poor pregnancy outcome] were handled appropriately and
whether the transfer guidelines were adequate to address such
circumstances. For purposes of
participation in such activities, the RPC representative or representatives
shall be deemed member(s) of the affiliate’s quality assurance committee.
Newborns requiring extraordinary care
shall be placed in a [special care nursery]NICU and hospitals shall
develop and implement protocols for all phases of treatment of such
newborns. Newborns [requiring
extraordinary care] who are delivered
in [Level 1] perinatal care [programs]services that are not capable of
providing all necessary care and services shall be transferred to [Level
III] perinatal care [programs]services at hospitals that can meet the
newborns’ needs.
(h) [Neonatal special care services provided by Level II and III perinatal care facilities.
(1)
Level III perinatal care facilities which provide neonatal special care services
and are designated as regional perinatal care centers shall provide care and
services in accord with the patient care provisions of section 708.5(f)(3) of this Title.] Neonatal intensive care services.
(1)
Neonatal intensive care services shall be provided by Level II, Level III and
RPC perinatal care hospitals.
(2)
[Level II and III perinatal care facilities providing intensive and/or
intermediate neonatal care but not designated as regional perinatal care
centers shall provide care and services in accord with the patient care
provisions of section 708.5(f)(4) and (5) of this Title. ] Decisions regarding the appropriate level
of care and the need for transport of a neonate to a higher level of care shall
be made consistent with generally accepted standards of care and the hospital’s
perinatal affiliation agreement.
(3) Treatment of severely ill, injured, or handicapped infants with life-threatening conditions.
(i) Severely ill, injured or handicapped infants exhibiting life-threatening conditions shall be transferred to and/or treated at RPCs or other hospitals having Level III perinatal care [programs]services after consultation with that [program]service has established that the infant might benefit from such transfer.
721.2 Definitions
(a) Level I
perinatal care service means a comprehensive maternal and newborn service
provided by a hospital designated as such by the department for normal low-risk
newborns and for women who have been assessed as having a normal, low-risk
pregnancy and having a fetus which has been assessed as developing normally and
without apparent complications.
(b) Level II
perinatal care means a comprehensive maternal and newborn service provided by a
hospital designated as such by the department which includes services for
moderately high-risk newborns and for women who have been assessed as having
the potential or likelihood for a moderately complicated or high-risk delivery
and/or bearing a fetus exhibiting the potential for unusual or high-risk
development. Such services may also provide services to women requiring care
normally provided at Level I perinatal care services.
(c)
Level III perinatal care means a
comprehensive maternal and newborn service provided by a hospital designated as
such by the department and which includes services for women and newborns who have been assessed as high-risk patients
and/or are bearing high-risk fetuses , who will require a high level of
specialized care. Such programs may
also provide services to women and newborns requiring care normally provided at
Level I and II perinatal care services; or
(d)
Regional Perinatal Center (RPC) means a hospital or hospitals housing a
perinatal care service which meets the standards for a Level III perinatal care
service but which also, includes highly specialized services that may not be
available at all Level III hospitals, and designated as such by the
department. An RPC serves a geographic
area or a group of perinatal affiliates.
It provides all aspects of comprehensive maternal and neonatal care, and
its functions and responsibilities also include efforts to coordinate and
improve quality of perinatal care among its affiliates, attending level
consultation regarding patient transfer and clinical management, transport of
high-risk patients, outreach to affiliates to determine educational needs,
education and training of affiliate hospitals, data collection, evaluation and
analysis within that region. If two or
more hospitals jointly sponsor an RPC, they must define in a written agreement
between or among the hospitals comprising the RPC how the aforementioned
functions and responsibilities will be carried out.
(e) Perinatal affiliation agreement shall
mean a written agreement between a Level I, II or III perinatal care hospital,
and that hospital’s designated RPC. A
perinatal affiliation agreement shall include provisions for, at a minimum:
(1) criteria, policies and procedures for
transfer of patients, with appropriate consent, to the RPC and from the RPC
back to the sending hospital;
(2)
criteria and process for consultation;
(3)
participation in the statewide perinatal data system;
(4) cooperation in outreach, education, training
and data collection activities; and
(5)
authority for one geographically accessible RPC to participate in quality
assurance/quality improvement reviews of the quality of the affiliate’s
perinatal care with the RPC designating appropriate RPC staff to review and
participate in quality assurance and quality improvement activities at the
affiliate hospital site. For purposes
of such review and participation, the RPC representative or representatives
shall be deemed member(s) of the affiliate’s quality assurance committee;
(6)
RPC involvement in the development of written agreements among perinatal affiliates
including criteria regarding transport of women and newborns;
(7)
timely consultation on treatment plans for women and neonates who develop or
exhibit unanticipated conditions which may require transfer to a higher level
of care;
(8)
resolution of disputes or disagreements between the RPC and the perinatal
affiliate, including disagreements regarding interpretation of affiliation
agreement criteria for consultation and/or transfer. In cases of disputes or disagreement between an affiliate and its
RPC, the affiliate and the RPC shall follow the dispute resolution process
outlined in their perinatal affiliation agreement. If the dispute is not resolved within sixty days, the parties
must request review by the department.
The department shall initiate compliance reviews at both sites, advise
each facility of its findings, and require corrective action, as indicated, to
resolve the dispute. This process shall
not interfere with the timely and proper transfer of mothers and newborns.
(f)
Transfer agreement shall mean a written agreement between a Level I or II perinatal service and a Level III
hospital for the transfer of patients requiring Level III care. Perinatal
transfer agreements shall address the provision and/or coordination of all
high-risk maternal and newborn transports.
The agreements shall reflect the following:
(1)
the maximum allowable surface travel time to reach a Level III or RPC hospital
shall be two hours under usual weather and road conditions, and the receiving
hospital shall be accessible and convenient
to the mother’s place of residence whenever possible;
(2)
mutually agreed criteria for determining when consultation and/or transfer is
required;
(3)
procedures and responsibility for arranging transport;
(4)
requirement for 24-hour availability of appropriately qualified RPC medical
staff to respond to calls from affiliates;
(5)
policies for obtaining patient or parent/guardian consent for patient transfer
and to exchange medical information;
(6)
procedures for making arrangements for transfer to another hospital if the
receiving hospital is unable to accept the transfer due to capacity/bed
limitations;
(7)
a provision that an emergency transport shall depart within thirty minutes of
the request for transfer;
(8)
provisions for the back transfer of newborns who no longer need Level III or
RPC care but who need continuing care in a hospital located near their home
communities shall be part of the perinatal affiliation and/or transfer
agreements between two hospitals; and
(9)
higher level hospitals shall inform referring hospitals of major changes in
status of transferred patients, with patient’s consent.
(g) Definitions contained in section 405.21(b)
of this Title shall apply to this Part.
721.3 Perinatal designation of hospitals.
(a)
Perinatal services will be designated by the Commissioner based on the
following:
(1)
each hospital designated as a Level I, Level II or Level III hospital shall
enter a written perinatal affiliation agreement with an RPC;
(2)
the level of care currently provided by the hospital shall meet the definition,
standards and criterion set forth in this Part for a Level I, Level II, Level
III perinatal service or RPC;
(3)
for level II, Level III and RPCs, the number of births and intensity of
neonatal care at the hospital during the previous full calendar year must meet
the following minimum volume standards:
(i)
a Level II perinatal care hospital shall provide no fewer than 1,200 high risk newborn patient days annually, and
no fewer than 150 high risk maternal patient days annually;
(ii)
a Level III perinatal care hospital shall provide no fewer than 2,000 high risk
newborn patient days annually, and no fewer than 250 high risk maternal patient
days annually;
(iii)
RPCs shall provide no fewer than 4,000 high risk newborn patient days annually,
and no fewer than 400 high risk maternal patient days annually. An RPC shall provide quality assurance and
improvement services to a group of perinatal affiliates with a minimum total of
8,000 births each year;
(4)
the availability of appropriate medical, nursing, and other staffing as
described in this Part supportive of the perinatal service at the hospital; and
(5)
surface travel time for transfers. The
surface travel time to reach a Level II hospital, a Level III hospital, or an
RPC within the geographic area or affiliative perinatal network, under usual
travel conditions shall be no more than two hours. Transfer decisions must be
based on the appropriate level of
perinatal care required, and care shall be provided at a hospital offering the
appropriate level of care which is accessible and convenient to the mother’s place of residence whenever
feasible.
(6) the geographic distribution of
designated hospitals throughout the state to ensure access to appropriate
levels of care throughout the state;
(7) such other additional information as the
Commissioner may require to make the designation.
721.4 Patient care and patient transfers.
(a) Each hospital providing perinatal care services
shall provide patient care in accordance with the following:
(1)
A Level I perinatal care service hospital shall evaluate and stabilize all
women and neonates.
(i) For patients needing a higher level of care,
it shall consult with a higher level hospital and arrange for timely transfer
to a Level III perinatal care service hospital or an RPC that provides the
appropriate level of perinatal care.
(ii) For healthy women with an anticipated
delivery at 36 weeks gestation or later and for healthy newborns with a
birthweight of 2,500 grams or more, it shall provide continuing care until
their discharge.
(iii)
Except in unusual circumstances, smaller and more premature infants shall be
delivered at higher level hospitals; if such an infant is born at a Level I
perinatal care hospital, he/she shall be transferred promptly after birth.
(iv)
Women and neonates who have relatively minor problems that
do not require advanced laboratory, radiologic, or consultation services may
remain in the Level I perinatal care hospital.
(v)
When it is known that the newborn may require immediate
complex care, it shall be delivered at a Level III perinatal care hospital or
an RPC whenever possible.
(vi) Level I perinatal care hospitals shall also
provide care for convalescing babies who have been transferred from Level
II, Level III and RPC perinatal care
hospitals.
(2)
A Level II perinatal care services hospital shall:
(i)
perform the Level I perinatal care services described in paragraph (1) above
and be capable of providing care for moderately high-risk women, fetuses and
newborns and moderately ill women and newborns who have problems that do not
require highly specialized care; and
(ii)
stabilize ill women and newborns and women whose fetuses are expected to need
complex care, consult with a higher level hospital and arrange for timely
transfer to a hospital that provides the appropriate level of prenatal
care.
(iii)
Level II perinatal care hospitals are qualified to deliver infants with an
anticipated delivery at 30 weeks
gestation or later and with an anticipated
birthweight of 1,250 grams or more.
(iv)
Except in unusual circumstances, infants smaller and more premature than is
described at subparagraph (iii) of this paragraph shall be delivered at Level
III hospitals or RPCs. If an infant who
is smaller or a lower gestational age than described in subparagraph (iii) of
this paragraph is born at the Level II hospital, he/she shall be transferred
promptly after birth.
(3)
A Level III perinatal care services hospital shall:
(i) perform Level I and Level II perinatal care services described in paragraphs (1) and (2) of this subdivision and shall care for women, fetuses, and newborns who may require complex care.
(ii)
stabilize ill women and newborns prior to transfer, including women whose
newborns are expected to need the most complex care, consult with its
designated RPC, and transfer if appropriate.
(iii)
Women in unstable medical and/or obstetric situations shall be cared for at a
Level III hospital or an RPC.
(4)
Regional Perinatal Care Centers (RPC) shall perform Level I, Level II and Level
III perinatal care services described in paragraphs (1), (2), and (3) of this
subdivision and shall also care for women, fetuses, and newborns who require
highly specialized services not available at the Level III care hospital, such
as sophisticated ventilation techniques (e.g., high-frequency ventilation and
extracorporeal membrane oxygenation ), cardiac surgery or neurosurgery.
(b) Ventilation for distressed newborns. Resuscitation and ventilation of neonates
who require cardiorespiratory assistance shall be performed at each Level of
perinatal care and in the following ways:
(1)
at a Level I perinatal care services hospital the ventilation of distressed
newborns shall be immediate resuscitation after birth as appropriate,
stabilization, and assisted ventilation of
newborns until timely transfer to a hospital that provides a higher
level of perinatal care;
(2)
at a Level II perinatal care hospital the ventilation of a distressed newborn
shall be as described in paragraph (1) above and, in addition, standard
short-term mechanical ventilation. A Level II perinatal care hospital may care
for infants requiring assisted ventilation and/or 50% or more oxygen for no
more than four days. By the fourth day
of a newborn’s receipt of assisted ventilation or oxygen at 50% or more, the
Level II hospital shall consult with its designated RPC regarding the status of
the newborn and determine whether to transfer the newborn to a higher level
hospital. If after such consultation
the neonate stays at the Level II hospital, that hospital may retain the
neonate for no more than a total of seven days on assisted ventilation or oxygen
at 50% and must then transfer the neonate to a Level III hospital or to an RPC.
(3)
at Level III perinatal care services hospitals and RPCs the ventilation of a
distressed newborn shall be as described in paragraphs (1) and (2) of this
subdivision and, in addition, may also include
long-term standard mechanical ventilation and complex ventilation
techniques, such as high‑frequency ventilation and extracorporeal
membrane oxygenation (ECMO).
(2)
When a newborn and/or mother requires transfer, care shall be provided at a
hospital providing the appropriate
level of perinatal care which
is, whenever feasible, accessible and convenient to the mother’s place of
residence. When mothers and their
infants need different levels of care, efforts shall be made to keep the mother‑newborn
dyad together. Level III hospitals and
RPCs shall return a newborn to the sending hospital when the condition has been
stabilized and return is medically appropriate.
721.5 Responsibilities and qualifications of
chiefs of services at each designated level.
The qualifications and responsibilities for each designated level shall
be as follows:
(a) Level I perinatal care service. Care shall be coordinated jointly by the
chiefs of obstetrics, pediatrics,
family practice, nursing, anesthesia, and midwifery. For facilities that do not have chiefs of
service in all such areas, each discipline shall have effective input in care
coordination. The coordinators of
perinatal care at a Level I perinatal care services hospital shall be
responsible for developing policy, maintaining standards of care, and
collaborating and consulting with professional staff of hospitals providing
Level II and Level III perinatal care services and RPC perinatal care in the
region. In hospitals that do not
separate maternity and newborn services, one person may be given the
responsibility for coordinating perinatal care;
(b) Level II perinatal care service. A board-certified obstetrician with special
interest, experience, and expertise in maternal-fetal medicine shall be the
chief of the obstetric service at a Level II care hospital. A full-time board-certified pediatrician
with subspecialty certification in neonatal medicine or equivalent training and
experience shall be the chief of the neonatal care services. These physicians shall jointly coordinate
the hospital’s perinatal care services and, in conjunction with the chiefs of
anesthesiology, nursing, midwifery, and family practice, and other patient care
and administration staff, shall develop policies concerning staffing,
procedures, equipment, and supplies; maintaining standards of care; and
planning, developing, and coordinating in-hospital professional educational
programs;
(c) Level III perinatal care services. The chief of the maternal-fetal medicine
service at a hospital providing Level III perinatal care shall be a full-time,
board-certified obstetrician with interest, experience and special competence
in maternal-fetal medicine; subspecialty certification in maternal-fetal
medicine is recommended. The director
of a newborn intensive care service at a Level III hospital shall be a
full-time, board-certified pediatrician with subspecialty certification in
neonatal medicine. These physicians
shall jointly coordinate the hospital’s perinatal care services in order to
ensure provision of a comprehensive continuum of high quality care to mothers
and newborns. In conjunction with the
chiefs of anesthesiology, nursing, midwifery, and family practice, and other
patient care and administrative staff, these physicians shall be responsible
for developing policies concerning staffing, procedures, equipment, and
supplies; maintaining standards of care; and planning, developing, and
coordinating in-hospital professional educational programs;
(d) RPC care. The chief of the maternal-fetal
medicine service at an RPC shall be a full-time, board-certified obstetrician
with subspecialty certification in maternal-fetal medicine. The chief of a newborn intensive care
service at an RPC shall be a full-time, board-certified pediatrician with
subspecialty certification in neonatal medicine. These physicians shall jointly
coordinate perinatal care services in order to ensure provision of a
comprehensive continuum of high quality care to mothers and newborns. In
conjunction with the chiefs of anesthesiology , nursing, midwifery, and family
practice, and other patient care and administration staff, these physicians
shall be responsible for developing policies concerning staffing, procedures,
equipment, and supplies; maintaining standards of care; and planning,
developing, and coordinating in-hospital professional educational
programs. The chiefs of maternal-fetal
medicine and neonatology will also be responsible for providing outreach and
professional education programs, participating
in the evaluation and improvement of perinatal care in the region, and
coordinating the services provided at their hospital with those provided at
Level I, Level II and Level III care hospitals in the region.
721.6 Qualifications and responsibilities of licensed obstetrical practitioners
at each designated level of care. The
qualifications and responsibilities of licensed obstetrical practitioners at
each designated level of care shall be:
(a) Level I perinatal care: A physician or licensed midwife with
appropriate training and expertise shall attend all deliveries. At least one person capable of initiating
neonatal resuscitation shall be present at every delivery. An ultrasound machine shall be readily
available to labor and delivery. A
radiologist or obstetrician skilled in interpretation of ultrasound scans shall
be available within 20 minutes;
(b) Level II perinatal care: A physician or licensed midwife with
appropriate training and expertise shall attend all deliveries. At least one person capable of initiating neonatal
resuscitation shall be present at every delivery. An ultrasound machine shall be readily available to labor and
delivery. A radiologist or obstetrician skilled in interpretation of ultrasound
scans shall be available 24 hours a day within a timeframe appropriate to meet
the patient’s needs. Portable,
neonatal-appropriate equipment and appropriately trained personnel to
administer the service must be available within a timeframe appropriate to meet
the patient’s needs. Care for
moderately high-risk women and neonates shall be provided by appropriately
qualified physicians. General
pediatricians and general obstetricians with the expertise to assume
responsibility for acute care for infants and women, shall be immediately
available within 20 minutes, 24 hours a day to provide needed services. The chief of obstetric anesthesia services
shall be board-certified in anesthesia and shall have training and experience
in obstetric anesthesia. A
neonatologist shall be available within a timeframe appropriate to meet the
patient’s needs 24 hours a day . The
hospital staff shall also include a radiologist skilled in interpretation of
ultrasound scans, a clinical pathologist , personnel qualified to administer
specialized pharmaceutical services to newborns, and a designated, in-house
credentialed person for neonatal resuscitation, all of whom shall be available
24 hours a day. Personnel with
credentials to administer obstetric anesthesia shall be readily available. Specialized adult and pediatric medical and
surgical consultation shall be readily available;
(c) Level III and RPC perinatal care: A physician or licensed midwife with
appropriate training and expertise shall attend all deliveries. At least one person capable of initiating
neonatal resuscitation should be present at every delivery. An ultrasound machine shall be readily
available to labor and delivery. A
radiologist, obstetrician or maternal-fetal medicine specialist skilled in
interpretation of ultrasound scans shall be available in-house 24 hours a
day. Portable, neonatal-appropriate
equipment and appropriately trained personnel to administer the service must be
available within a timeframe appropriate to meet the patient’s needs. Maternal-fetal medicine specialists and
neonatologists who care for high risk mothers and newborns in the Level III or
RPC hospital shall have qualifications equivalent to those of the chief of
their service as described in section 721.5(c) and (d) of the Title. A maternal-fetal medicine specialist and a
neonatologist shall be readily available for consultation 24 hours a day. Obstetric
and neonatal diagnostic imaging, provided by radiologists with special
expertise in diagnosis of maternal and
neonatal disease and its complications, shall be available 24 hours a
day. Pediatric and adult subspecialists
in cardiology, neurology, hematology, genetics, nephrology, metabolism,
endocrinology, gastroenterology, nutrition, radiology, infectious diseases,
pulmonology, immunology, and pharmacology shall be available for
consultation. In addition, pediatric
surgeons and pediatric surgical subspecialists, e.g., cardiovascular,
neurological, orthopedic, ophthalmologic, urologic, and otolaryngological
surgeons, shall be available for consultation and care. Pathologists with special competence in placental, fetal, and neonatal
disease shall be members of the Level III or regional perinatal center
staff. A clinical pathologist shall be
available 24 hours a day. A
board-certified anesthesiologist with special training or experience in
maternal-fetal anesthesia shall be in charge of obstetric anesthesia services
at a Level III or regional perinatal center facility, and personnel with
credentials in the administration of obstetric anesthesia shall be available
for all deliveries. Personnel with
credentials in the administration of neonatal and pediatric anesthesia shall be
readily available as needed. Personnel
qualified to prepare, dispense and administer specialized pharmaceutical
services to newborns shall be available 24 hours a day.
721.7 Nursing Care. In addition
to providing nursing care that meets generally accepted professional standards,
hospitals shall meet the following additional nursing requirements at each
designated level of care.
(a) Level I perinatal care service
hospital. Maternal and newborn nursing
care shall be provided under the direct supervision of a registered nurse. All obstetric nursing personnel shall be
qualified in interpretation of fetal heart rate monitoring and understand the physiology
of labor. All newborn nursing personnel
shall be qualified in assessment of the newborn and all aspects of routine
monitoring and care, including education and support related to breastfeeding.
(b) Level II care hospital. In addition to the qualifications described
in subdivision (a) of this section, direct patient care shall be provided by
registered nurses who have education or experience in the care of moderately
high-risk women and/or newborns. All
nurses caring for ill women or newborns shall possess demonstrated knowledge in
the observation and treatment of such patients, including cardiorespiratory
monitoring. Registered nurses in a Level II perinatal care hospital shall be
able to: monitor and support the stability of cardiopulmonary, neurologic,
metabolic, and thermal functions; assist with special procedures such as lumbar
puncture, endotracheal intubation, and umbilical catheterization; and perform
emergency resuscitation.
(c) Level III perinatal care hospital. Responsibilities of registered nurses shall
include those defined in subdivisions (a) and (b) of this section. In addition, registered nurses in the Level
III perinatal care hospital shall have specialty certification or advanced training
and experience in the nursing management of high-risk women, neonates and their
families. They shall also be
experienced in caring for unstable women and neonates with multi-organ system
problems and in specialized care technology.
An advanced practice nurse shall be available to the staff for
consultation and support on nursing care issues. Assessment and monitoring activities shall remain the
responsibility of a registered nurse or
advanced practice nurse in obstetric-neonatal nursing, even when personnel with
a mixture of skills are used;
(d) RPC.
Responsibilities of registered nurses shall include those defined in
subdivisions (a), (b), and (c) of this section. In addition, nurses with special training shall participate in
regional perinatal center responsibilities such as outreach, training,
education and support.
721.8 Ancillary personnel. The
ancillary personnel requirements for each designated level are as follows:
(a) All designated Level I, II, III perinatal
care services and RPCs shall have:
(1)
an organized plan of action that includes personnel and equipment for
identification and immediate resuscitation of newborns and mothers requiring
cardiorespiratory assistance;
(2)
personnel who are capable of determining blood type, cross-matching blood, and
performing antibody testing and who are available on a 24-hour basis;
(3)
infection control personnel responsible for surveillance of infections in women
and neonates, as well as for the development of an appropriate environmental
control program;
(4)
a radiologic technician available 24 hours a day to perform imaging;
(5)
at least one staff member with expertise in lactation and breastfeeding
management responsible for the hospital’s breastfeeding support program, as
described in section 405.21(f)(3)(i) of this Title;
(6)
at least one staff member with expertise in bereavement responsible for the
hospital’s bereavement activities, including a systematic approach to ensuring
that individuals in need receive such services;
(7)
at least one qualified social worker available who has experience with the
socioeconomic and psychosocial problems of pregnant women, ill neonates, and
their families assigned to the perinatal service. Additional qualified
social workers sufficient to meet the needs of women and newborns are
required when there is a high volume of medical activity or psychosocial need;
(8)
licensed practical nurses and other licensed patient care staff with
demonstrated knowledge and clinical competence in the nursing care of women,
fetuses, and newborns during labor, delivery, and the postpartum and neonatal
periods.
(9)
The need for other support personnel shall depend on the intensity and level of
sophistication of the other support services provided and shall be
sufficient to meet the needs of the
patients.
(b) Additional requirements for Level II, Level
III perinatal care services and RPC designation:
(1)
at least one occupational or physical therapist with neonatal expertise;
(2)
at least one registered dietician/nutritionist who has special training in
perinatal nutrition and can plan diets that meet the special needs of high-risk
women and neonates;
(3)
appropriate and adequate numbers of the nursing staff who are trained in
breastfeeding support for mothers and infants with special needs;
(4)
qualified personnel for support services, such as laboratory studies,
radiologic studies, and ultrasound examinations, who are available 24 hours a
day; and
(5) respiratory therapists or nurses with special training who can supervise the assisted ventilation of neonates with cardiopulmonary disease.