Current through Register Vol. 46, No. 39, September 25, 2024
(a)
Applicability.
This section shall apply to all general hospitals having
maternity and newborn services and providing pregnancy-related care for women
who are pregnant at any stage, parturient or within six weeks from delivery and
for infants 28 days of age or less or, regardless of age, who are less than
2,500 grams (51/2 pounds).
(b)
Definitions.
For the purposes of this section:
(1)
Perinatal services shall
mean those services provided in a particular hospital where, as a regular
practice, maternity patients and newborn infants receive care on a continuum
ranging from preconception services to care during all stages of pregnancy,
parturition, postpartum and neonatal care.
(2)
Perinatal regionalization
system shall mean the statewide organization of maternal and newborn
health care services, designed as set forth in Part 721 of this Title, to
ensure that mothers and newborns receive the care they need in a timely, safe
and effective manner.
(3)
Labor room shall mean a room for parturient patients in labor,
distinct from patient bedrooms and from operating or delivery rooms.
(4)
Delivery room shall mean
a room distinct from patient bedrooms and set apart for the delivery of
parturient patients.
(5)
Single unit maternity or labor-delivery-recovery-postpartum
model shall mean a model for family-centered maternity and newborn
care in which labor, delivery, nursery and postpartum care are all provided in
a single room and movable equipment is introduced and withdrawn from the room
as required to provide services and care to the mother and neonate.
(6)
Rooming-in shall mean an
arrangement which allows the mother and her newborn infant to be cared for
together, so that the mother may have access to her infant during all or a
substantial part of the day and night, not limited to feeding times.
(7)
Newborns shall mean all
infants 28 days of age or less.
(8)
Premature infant shall mean an infant whose gestational age at
birth calculated from the first day of the last menstrual period, or using
another reliable method for patients with an unreliable history, is less than
37 completed weeks or 258 completed days.
(9)
Low birth weight infant
shall mean an infant weighing less than 2,500 grams (51/2 pounds) at
birth.
(10)
Normal newborn
nursery shall mean a room for housing newborns who do not need
intensive care and are not suspected of nor diagnosed as having any
communicable condition.
(11)
Neonatal intensive care unit (NICU) shall mean a room at Level
II, Level III and Regional Perinatal Center perinatal care services for housing
newborns, including premature infants and low birth weight infants, who require
specialized care and who are not suspected of nor diagnosed as having any
communicable condition.
(12)
Observation nursery shall mean a room, physically separate
from the normal newborn nursery, where newborns exposed to potential sources of
infection and newborns suspected of but not diagnosed as having any
communicable condition may be observed pending diagnosis.
(13)
Isolation nursery shall
mean a room, physically separate from other nurseries, for the isolation of
newborns diagnosed as having any communicable condition.
(14)
Family planning shall
mean the planning and spacing of children by medically acceptable methods to
achieve pregnancy, or prevent unintended pregnancy.
(15)
Level I perinatal care
service shall mean a comprehensive maternal and newborn service as
defined by section
721.2(a) of this
Title.
(16)
Level II
perinatal care service shall mean a comprehensive maternal and newborn
service as defined by section
721.2(b) of this
Title.
(17)
Level III
perinatal care service shall mean a comprehensive maternal and newborn
service as defined by section
721.2(c) of this
Title.
(18)
Regional
perinatal center (RPC) shall mean a hospital or hospitals housing a
Level III perinatal care 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 as defined in Part 721 of this
Title.
(20)
Birth
center shall mean a place, other than a traditional hospital
childbirth unit or birthing room, where births are planned to occur away from
the mother's usual residence following a normal uncomplicated
pregnancy.
(21)
Birthing
room shall mean a hospital room designed as a homelike setting which
serves as a combined labor/delivery/recovery room and where family members or
other supporting persons may remain with a woman as much as possible throughout
the childbirth process.
(22)
Quality improvement shall mean improvement of the quality of
care provided by the RPC or affiliate hospitals through initiatives and
analyses designed to identify and then address potential problem areas in care
in its own hospital or in affiliated hospitals, or in the region as a whole,
through review of either sentinel cases or patterns of
care.
(c)
General
requirements.
(1) Hospitals providing
perinatal services shall provide such services in accordance with current
standards of professional practice. Written policies and procedures shall be
developed and implemented which address the following:
(i) the professional qualifications of the
hospital's obstetric and pediatric staff;
(ii) the requirements for consultation with a
qualified specialist when required by specific medical conditions;
(iii) the establishment and implementation of
rooming-in at the option of each patient unless the establishment or
implementation of such program for that patient is medically contraindicated or
unless the hospital does not have sufficient facilities to accommodate all such
requests;
(iv) protocols and
resources available to stabilize and assess newborns for their need of neonatal
intensive care; and
(v) the daily
care of maternity patients and infants in the perinatal
service.
(2) Medical
record for each maternity patient. The medical record for each maternity
patient admitted to the perinatal service shall be maintained in accordance
with section
405.10 of this Part and also shall
include the following:
(i) a copy or abstract
of the prenatal record, if existing, including a maternal history and physical
examination as well as results of maternal and fetal risk assessment, results
of maternal HIV, Hepatitis B and Group B strep testing if done, and ongoing
assessments of fetal growth and development and maternal health;
(ii) the results of a current physical
examination performed by staff granted privileges to perform such examination
that meets the requirements of section
405.9(b)(11) of
this Part; and
(iii) labor and
birth information including records of fetal monitoring and postpartum
assessment.
(3) Medical
record for each newborn. The medical record for each newborn shall be
cross-referenced with the mother's medical record and contain the following
additional information:
(i) newborn physical
assessment, including APGAR scores, presence or absence of three cord vessels,
ability to feed, vital signs and accommodation to extrauterine life;
(ii) newborn care, including the
administration of eye prophylasis and vitamin K;
(iii) description of maternal-newborn
interaction; and
(iv) orders for
newborn screening tests, including arrangements for screening for
hearing.
(4) The hospital
shall ensure the transfer to the newborn's medical records of a mother's HIV
test result, if one exists.
(5) The
hospital shall maintain in a timely manner in the perinatal service area, a
register of births, in which shall be recorded the name of each patient
admitted, date of admission, date and time of birth, type of delivery, names of
personnel present in the delivery room, sex, weight and gestational age of
infant, location of delivery and outcome of delivery. Any delivery for which
the institution is responsible for filing a birth certificate shall be listed
in this register.
(6) Control of
infection or other communicable condition. The provisions of section
405.11 of this Part shall apply to
the perinatal service. In addition, the following requirements relating to the
control of infection or other communicable conditions in the perinatal service
shall be met:
(i) each patient admitted to
the labor-delivery unit shall be screened for signs of, or exposure to,
infection. Those with suspected or confirmed communicable conditions shall be
reported to the responsible attending practitioner and the infection control
officer for observation or isolation as required;
(ii) isolation precautions shall be carried
out for patients in labor with confirmed or suspected infection. There shall be
at least one room readily available for the use of a maternity patient
requiring isolation. The hospital shall implement safe and effective isolation
precautions to prevent the spread of infection and assign professional and
other staff in the perinatal service in a manner that will prevent the spread
of infection. Written policies and procedures shall be developed and
implemented reflecting such isolation precautions;
(iii) the hospital shall adopt and implement
written policies and procedures governing the placement in observation or
isolation nurseries of infants exposed to or showing signs of developing an
infection or communicable condition. Such policies shall not unnecessarily
restrict the mother's access to her infant; and
(iv) infection control measures shall be
instituted to protect infants when the care and treatment of infants requires
common surfaces.
(7)
Preconception services. The hospital shall develop and implement written
policies and procedures for preconception services either onsite or through
referral arrangements. Services shall include but not be limited to family
planning, nutritional assessment and counseling, genetic screening and
counseling, and identification and treatment of medical conditions that could
adversely affect a future pregnancy.
(8) Hospital prenatal care activities.
(i) The hospital shall participate in and
shall provide or arrange for effective prenatal care activities including
conducting effective community outreach programs either directly or in
collaboration with community-based providers and practitioners who provide
prenatal care and services to women in the hospital service area. Activities
and services of a prenatal care program shall include but not be limited to the
following:
(a) active promotion of prenatal
care for pregnant women during the first trimester of pregnancy and making
services available to patients seeking initial care during each
trimester;
(b) the initial prenatal
care visit shall include a complete history, physical examination, pelvic
examination, laboratory screening, initiation of patient education, screening
for nutritional status, nutrition counseling and use of a standardized prenatal
risk assessment tool;
(c)
arrangements for repeat visits for follow-up prenatal care and
education;
(d) nutrition
counseling;
(e) psychosocial
support services as needed;
(f)
ongoing maternal and fetal risk assessment;
(g) prebooking for delivery; and
(h) providing HIV counseling and a clinical
recommendation for testing to pregnant women. Counseling and/or testing, if
accepted, shall be provided pursuant to Public Health Law, article 27-F.
Information regarding the woman's HIV counseling and HIV status must be
transferred as part of her medical history to the labor and delivery site.
Women with positive test results shall be referred to the necessary health and
social services within a clinically appropriate time.
(ii) To perform the activities and provide
the services in subparagraph (i) of this paragraph, the perinatal service shall
accommodate and coordinate services with primary care providers as follows:
(a) the hospital shall develop a memorandum
of understanding with each diagnostic and treatment center, prenatal care
provider who is not a member of the medical staff and prenatal care assistance
program in the hospital service area. These memoranda shall establish protocols
for the provision of prenatal care, testing, prebooking arrangements, timely
transfer of records and other necessary services; and
(b) the hospital shall require as a condition
of continuing medical staff membership that medical staff members provide to
maternity patients under their care prenatal care, prebooking arrangements,
testing, timely transfer of records and other necessary services. Written
policies and procedures implementing this requirement shall be
developed.
(iii)
Hospitals shall assure the availability of prenatal childbirth education
classes for all prebooked women which address as a minimum the anatomy and
physiology of pregnancy, labor and delivery, infant care and feeding,
breastfeeding, parenting, nutrition, the effects of smoking, alcohol and other
drugs on the fetus, what to expect if transferred, and the newborn screening
program with the distribution of newborn screening educational
literature.
(iv) The hospital shall
assure that each prebooked woman receives the hospital's maternity information
leaflet as described in PHL section 2803-j, which includes a written
description of available options for labor, delivery and postpartum services.
The attending practitioner shall:
(a) advise
the woman of options for treatment, care and technological support that are
expected to be available at the time of labor and delivery together with the
advantages and disadvantages of each option;
(b) answer fully any questions the woman may
have regarding the options available; and
(c) obtain from the woman her informed choice
of mode of treatment, care and technological support that are expected to be
necessary.
(9)
Hospitals in consultation with the medical staff shall develop memoranda of
understanding with free-standing birth centers in their service area, upon
request from such centers, for the prompt admission of women and newborns and
transfer of records of any birth center patient whose assessed condition
necessitates admission to the level of perinatal service provided by such
hospital.
(i) Such transfer shall be
accomplished in accordance with the provisions of sections
754.2(e),
754.4,
795.2 and
795.4 of this Title.
(ii) Unless already performed at a
free-standing birth center, newborns transferred to a hospital shall have
newborn screening performed at the hospital in accordance with Part 69 of this
Title.
(iii) The hospital, as part
of its quality improvement activities, shall review all maternal and/or newborn
transfers from birth centers to ensure adequacy of risk assessment and care,
that each transfer has been appropriately arranged, and that reasons for the
transfer have been documented clearly.
(10) Quality improvement activities. In
addition to the quality assurance provisions of section
405.6 of this Part, the hospital
shall, in conjunction with the medical staff and the nursing staff, monitor the
quality and appropriateness of patient care and ensure that identified problems
are reported to the quality assurance committee together with recommendations
for corrective action. In accordance with section
721.9 of this Title, the hospital
shall also perform quality improvement activities in accordance with its
perinatal affiliation agreement.
(11) Functioning of perinatal services.
(i) Inpatient perinatal services shall be
operated as closed units with limited access to unnecessary hospital
traffic.
(ii) The perinatal service
shall have available: services for the identification of high-risk mothers and
fetuses, continuous electronic fetal monitoring, Cesarean delivery capabilities
within 30 minutes of determination of need for such procedure, anesthesia
services available on a 24-hour basis, radiology and ultrasound examination,
with at least one ultrasound machine immediately available for use by the labor
and delivery service.
(12) Laboratory services. The perinatal
service shall have immediate access to the hospital's laboratory services
including a 24-hour capability to provide blood group, Rh type and
cross-matching, and basic emergency laboratory evaluations. Either ABO
Rh-specific or O-Rh-negative blood and fresh frozen plasma shall be available
at the facility at all times. Such other procedures as may be required by the
perinatal service shall be performed on a timely basis.
(13) Admissions.
(i) Women in need of medical care and
services pertaining to pregnancy, delivery and the puerperal period shall be
admitted to the maternity service. Such admission shall be consistent with
section 405.9 of this Part.
(a) Each patient shall be attended by a
licensed and currently registered obstetrician, family practitioner or licensed
midwife who will be responsible for the patient's care.
(b) A patient may not be sent home without
the prior knowledge and approval of her attending physician or licensed
midwife.
(ii) Admission
of nonobstetric patients.
(a) The hospital
shall develop and implement written policies and procedures for the admission
of nonobstetric female patients to the perinatal service area. The hospital
shall ensure that obstetric patients take precedence over nonobstetric patients
and that the safety and physical and psychological well-being of obstetric
patients are not jeopardized.
(b)
The following nonobstetric patients shall not be admitted to the maternity
service:
(1) patients undergoing radiation
therapy while they retain radioactive materials that have been administered
for, or that result from, such treatment; and
(2) patients in an acute, infectious state or
with signs and symptoms which may denote infection.
(c) If an acute or chronic infection or any
other condition which would have contraindicated admission to the perinatal
service is found during surgery or during any other period of hospitalization,
the patient shall be removed from the perinatal service
area.
(14)
Voluntary acknowledgement of paternity for a child born out of wedlock.
(i) If a child is born to an unmarried woman
and the putative father is readily identifiable to the responsible hospital
staff and available, the hospital shall:
(a)
provide to the child's mother and putative father documents and oral and
written instructions and information necessary for such mother and father to
complete an acknowledgement of paternity form in compliance with section
4135-b of
the Public Health Law and section
111-k of
the Social Services Law; and
(b)
file the executed acknowledgement of paternity with the registrar at the same
time at which the certificate of live birth is filed, if
possible.
(ii) The
hospital shall not be required to seek out or otherwise locate a putative
father who is not readily identifiable or available.
(15) Hospitals with a perinatal care service
shall participate in the perinatal regionalization system in accordance with
their level of care designations under Part 721 of this Title.
(16) Each hospital providing Level I, II or
III perinatal care services shall enter into a perinatal affiliation agreement
with its designated RPC in accordance with Part 721 of this Title. Level I and
II hospitals may also enter into transfer agreements in accordance with Part
721 with Level III hospitals.
(d)
High-risk antepartum services at
Level II, Level III and RPC perinatal services.
(1) Level II, Level III and/or RPC perinatal
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 intensive
care services.
(i) Hospitals providing Level
I or II perinatal care services shall develop, enter into and implement written
agreements with hospitals providing Level III and RPC perinatal care 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 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 care for 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 perinatal service.
(iv) Level II, Level III and RPC perinatal
care services shall maintain a nursing staff in accordance with the annual
clinical staffing plan established under paragraph (8) of subdivision (a) of
section 405.5 of this Title that is
appropriately trained and adequate in size to provide specialized care to
distressed patients. The number of patient care staff on duty during any shift
shall reflect the volume and acuity of patient services being provided during
that shift.
(v) An RPC shall:
(a) offer education and training to its
perinatal affiliates and associated birth centers. Education and training shall
be designed to update and enhance staff knowledge and familiarity with relevant
procedures and technological advances;
(b) review, in conjunction with its perinatal
affiliates, all cases of patients transferred to a higher level of care to
determine whether such transfers were appropriate and accomplished according to
established transfer agreements; and
(c) participate in case conferences with its
perinatal affiliates and associated birth centers to determine whether any
non-transferred high-risk cases were handled appropriately and whether the
transfer guidelines were adequate to address such circumstances;
(d) for purposes of participation in such
activities, the RPC representative or representatives shall be deemed member(s)
of the perinatal affiliate's quality assurance committee. RPC representatives
may only access confidential patient information for quality improvement
purposes through their roles on the affiliate hospitals' quality assurance
committees as set forth in the affiliation agreements and these regulations.
Members of hospitals' quality assurance committees must maintain the
confidentiality of patient information and are subject to the confidentiality
restrictions of Public Health Law section 2805-m.
(e)
Intrapartum
services.
(1) The hospital shall
develop and implement written policies and procedures that indicate the areas
of responsibility of both medical and nursing personnel for normal, high-risk,
and emergency deliveries. These policies and procedures shall be reviewed
yearly and made available to all staff. There also shall be written policies
for the care of pregnant patients when all antepartum and postpartum beds are
occupied.
(2) Written policies and
procedures shall be developed and implemented governing restrictions of entry
to the closed labor and delivery unit and the hospital shall ensure that,
unless medically contraindicated, the patient may choose to be accompanied
during labor and delivery by the father and/or other supportive person(s) who
can provide emotional comfort and encouragement. Any such contraindications
shall be noted in the medical record.
(3) Evaluation and preparation.
(i) In conjunction with the required updated
history and physical exam, the hospital shall provide for the following:
(a) laboratory data including serologic tests
for blood group, Rh type, syphillis and rubella titer;
(1) if the woman's serology is positive, a
cord blood serology shall be obtained. If the sample could not be taken prior
to the pregnancy's end, the serology shall be taken at the time of termination
of the pregnancy;
(2) the woman
shall be evaluated for the risk of sensitization to Rho (D) antigen and if the
use of Rh immune globulin is indicated, an appropriate dosage thereof shall be
administered to her as soon as possible within 72 hours after delivery or
termination of pregnancy;
(b) an assessment of the woman's HIV status
and the provision of testing in accordance with section
69-1.3(l) of this
Title;
(c) an admitting physical
examination which shall include the woman's blood pressure, pulse and
temperature, the fetal heart rate, the frequency, duration and evaluation of
the quality of the uterine contractions and which shall be recorded in the
patient's medical record. An evaluation of any complications should be made. If
there is suspected leakage of amniotic fluid or any unusual bleeding, the
attending physician or licensed midwife shall be notified immediately before a
pelvic examination is performed. When there are no complications or
contraindications, qualified nursing personnel may perform the initial pelvic
examination to evaluate labor status and the imminence of delivery. The
physician or licensed midwife responsible for the woman's care shall be
informed of her status, so that a decision can be made regarding further
management; and
(d) interval
assessments including physical and psychological status of the woman and fetal
status.
(ii)
Pharmacological or surgical induction or augmentation of labor.
(a)
Qualified practitioner
as referred to in this section shall mean a practitioner functioning within his
or her scope of practice according to State Education Law who meets the
hospital's criteria for privileging and credentialing practitioners in
management of labor and delivery in accordance with the hospital's policies and
procedures.
(b) Pharmacological or
surgical induction or augmentation of labor may be initiated only after a
qualified practitioner has evaluated the woman, determined that induction or
augmentation is medically necessary for the woman or fetus, recorded the
indication, obtained informed consent for induction or augmentation of labor,
and established a prospective plan of management acceptable to the woman. If
the qualified practitioner initiating these procedures does not have privileges
to perform cesarean deliveries, a physician who has such privileges shall be
contacted directly prior to initiation of the induction or augmentation and a
determination made that he or she shall be available within 30 minutes of
determination of the need to perform a cesarean delivery. If the patient has
had a previous cesarean delivery, a physician with cesarean privileges must be
immediately available during pharmacological induction or augmentation of
labor.
(c) Pharmacological or
surgical induction or augmentation shall be initiated by a qualified
practitioner. A qualified practitioner shall initiate the induction or
augmentation and shall remain with the woman for a period of time sufficient to
ensure that the procedures or medication has been well-tolerated and has caused
no adverse reaction. A physician capable of managing any reasonably foreseeable
complications from the induction or augmentation of labor shall be available
within a timeframe appropriate to the woman's needs.
(d) For pharmacological induction or
augmentation of labor, the hospital shall develop and implement a written
protocol for the preparation and administration of the oxytocic agent and/or
other substances used to induce or augment labor.
(e) During the entire time of the labor
induction or augmentation, the woman shall be monitored by staff who are
trained and competent in both the monitoring of fetal heart rate and uterine
contractions and interpretation of such monitoring. The monitoring shall be by
either electronic fetal monitoring or auscultation. Where auscultation is used
in lieu of electronic fetal monitoring, it shall be performed no less
frequently than every 15 minutes during the first stage of labor and every five
minutes during the second stage of labor.
(iii) No attempt shall be made to delay birth
of an infant by physical restraint or anesthesia.
(iv) Each maternity patient, when present in
a labor, delivery, birthing room or birth center shall be under the care of a
registered professional nurse available in accordance with the patient's
needs.
(v) The medical record shall
be updated to note whenever the woman's choice of position for labor, use of
drugs or technological support devices or mode of treatment and care cannot be
honored due to medical contraindications. Standing orders for drugs or
technological support devices may only be implemented after the nature and
consequences of the intervention have been explained to the woman, and the
woman agrees to such implementation.
(4) Delivery.
(i) Hospitals shall develop and implement
policies and procedures for the delivery room that shall require at least the
following:
(a) regular evaluation of maternal
blood pressure and pulse both during and after delivery; and
(b) fetal heart
evaluation.
(ii) Section
405.13 of this Part concerning
anesthesia services shall apply to the clinical perinatal service. The
anesthetist shall be informed in advance if complications with the delivery are
anticipated.
(iii) The perinatal
service and the medical staff shall designate in writing those situations which
require consultation with and/or transfer of responsibility from a licensed
midwife or a family practice physician to an obstetrician.
(iv) Alternative arrangements for the
organization of the perinatal service, including but not limited to birthing
rooms, birth centers or single unit maternity models, shall conform to
pertinent requirements of this section and Parts 711 and 712 of this Title.
Birth centers shall also conform to the patient care provisions of Part 754 of
this Title.
(v) Immediate care of
the newborn. The practitioner who delivers the baby shall be responsible for
the immediate postdelivery care of the newborn until another qualified person
assumes this duty. At all times, the newborn shall be attended by a physician
or licensed midwife and shall be under the care of a registered professional
nurse.
(a) Resuscitation of a distressed
newborn. The hospital shall develop and implement policies and procedures for
the recognition and immediate resuscitation of a distressed newborn. Level I
and II perinatal care services shall accomplish this in consultation with, and
with assistance of, the RPC with which the hospital has a perinatal affiliation
agreement. The policies and procedures shall include the following elements:
(1) the designation of a physician to assume
primary responsibility for the establishment of standards of care, review of
practices, maintenance of appropriate drugs and training of
personnel;
(2) approval of these
policies and procedures by the directors of maternity and newborn services,
anesthesia, pediatrics, nursing and by the medical staff;
(3) requirement for immediate availability of
needed resuscitative equipment and personnel;
(4) presence in the delivery room of a member
of the professional staff specifically qualified in newborn
resuscitation;
(5) capability to
provide short-term respiratory support including bag and mask
ventilation;
(6) procedures for the
stabilization of the distressed newborn;
(7) capability to perform endotracheal
intubation and umbilical vessel catheterization. For a Level I perinatal care
service, the perinatal affiliation agreement with its designated RPC shall
provide for staff training to develop current staff competence in these
procedures; and
(8) procedures for
the preparation and transfer of the distressed newborn to a Level III or RPC
perinatal care service when medically indicated.
(b) The hospital shall administer eye
prophylaxis and vitamin K in accordance with sections 12.2 and
12.3 of this Title, test for
phenylketonuria and other diseases and provide or arrange for newborn hearing
in accordance with Part 69 of this Title.
(c) The hospital shall conduct expedited HIV
testing of a newborn whose mother's HIV status is unknown at delivery in
accordance with section
69-1.3(l) of this
Title;
(d) A professional staff
person in attendance at a delivery shall ensure proper identification of a
newborn before it leaves the room where the delivery has occurred.
(1) The hospital shall ensure continuous
identification of the newborn infant during the entire period of
hospitalization including verification of identity after each separation and
reunion of mother and newborn. In addition to the development and
implementation of written policies and procedures for continuous
identification, further policies and procedures shall set forth steps to be
taken when the means of identification which has been placed on the newborn
becomes separated from the newborn.
(2) Newborns born of different mothers shall
not be present at the same time in the room where delivery/recovery takes
place, unless each has previously been identified by the methods prescribed in
this clause.
(e)
Circumcision, which shall be an elective procedure, shall not be performed
during the newborn stabilization period after
birth.
(f)
Postpartum care of mother.
Appropriate nursing care shall be available to the mother
during the period of recovery after delivery. At all times after delivery, the
mother shall have maximum access to her baby unless such access is medically
contraindicated and recorded in the appropriate medical record.
(1) The mother shall be transferred to the
postpartum area only after her vital signs have stabilized. The hospital shall
adopt and implement policies and procedures for identifying any postpartum
complications that arise and informing the responsible practitioner who shall
manage complications.
(2)
Postpartum monitoring shall include the following:
(i) vital signs shall be recorded on a
regular basis;
(ii) fluid intake
and output shall be recorded. The uterine fundus shall be frequently examined
to determine if it is well contracted and whether there is excessive
bleeding;
(iii) the patient's
practitioner shall be notified of any unusual findings;
(iv) nursing personnel qualified to recognize
postpartum emergencies and problems shall be immediately available to the
patient;
(v) the father or other
support person shall be allowed to remain with the mother during the recovery
period unless medically contraindicated or unless the nursing staff determines
that the continued presence of the individual would interfere with the
continuing care of the mother or other patients;
(vi) a physical assessment of the mother
shall be conducted in accordance with established protocols; and
(vii) unless medically contraindicated or
unacceptable to the mother, the newborn shall remain with the mother who shall
provide a preferred source of body warmth for the newborn. During this period
the newborn shall be closely observed for any abnormal signs and breastfeeding
shall be encouraged.
(3)
Education and orientation of the mother who is planning to raise the baby.
(i) The hospital shall provide instruction
and assistance to each maternity patient who has chosen to breastfeed and shall
provide information on the advantages of breastfeeding and possible impacts of
not breastfeeding to women who are undecided as to the feeding method for their
infants. As a minimum:
(a) the hospital shall
designate at least one person who is thoroughly trained in breastfeeding
physiology and management to be responsible for ensuring the implementation of
an effective breastfeeding program. At all times, there should be available at
least one staff member qualified to assist and encourage mothers with
breastfeeding;
(b) written policies
and procedures shall be developed, updated, implemented, and disseminated
annually to staff providing maternity or newborn care to assist and encourage
the mother to breastfeed which shall include, but not be limited to:
(1) prohibition of the application of
standing orders for anti-lactation drugs;
(2) placement of the newborn skin-to-skin for
breastfeeding immediately following delivery, unless contraindicated;
(3) restriction of the newborn's supplemental
feedings to those indicated by the medical condition of the newborn or of the
mother;
(4) provision for the
newborn to be fed on demand;
(5)
pacifiers or artificial nipples may be supplied by the hospital to
breastfeeding infants to decrease pain during procedures, for specific medical
reasons, or upon the specific request of the mother. Before providing a
pacifier or artificial nipple that has been requested by the mother, the
hospital shall educate the mother on the possible impacts to the success of
breastfeeding and discuss alternative methods for soothing her infant, and
document such education;
(6)
prohibition of the distribution of marketing materials, samples or gift packs
that include breast milk substitutes, bottles, nipples, pacifiers, or coupons
for any such items to pregnant women, mothers or their families;
(7) prohibition of the use of educational
materials that refer to proprietary product(s) or bear product logo(s), unless
specific to the mother's or infant's needs or condition; and
(8) prohibition of the distribution of any
materials that contain messages that promote or advertise infant food or drinks
other than breast milk.
(c) the hospital shall provide an education
program as soon after admission as possible which shall include but not be
limited to:
(1) the importance of scheduling
follow-up care with a pediatric care provider within the timeframe following
discharge as directed by the discharging pediatric care provider;
(2) the nutritional and physiological aspects
of human milk;
(3) the normal
process for establishing lactation, including care of the breasts, common
problems associated with breastfeeding and frequency of feeding;
(4) the potential impact of early use of
pacifiers on the establishment of breastfeeding;
(5) dietary requirements for
breastfeeding;
(6) diseases and
medication or other substances which may have an effect on
breastfeeding;
(7) sanitary
procedures to follow in collecting and storing human milk; and
(8) sources for advice and information
available to the mother following discharge;
(d) for mothers who have chosen formula
feeding or for whom breastfeeding is medically contraindicated, hospitals shall
provide individual training in formula preparation and feeding
techniques.
(ii) The
hospital shall provide to the mother instructions in caring for herself and her
baby. Topics to be covered shall include but not be limited: to self-care,
nutrition, breast examination, exercise, infant care including taking
temperature, feeding, bathing, diapering, infant growth and development and
parent-infant relationships.
(iii)
The hospital shall determine that the maternity patient can perform basic
self-care and infant care techniques prior to discharge or make arrangements
for postdischarge instruction.
(iv)
Each maternity patient shall be offered a program of instruction and counseling
in family planning, if requested by the patient, the hospital shall provide the
patient with a list, compiled by the department and made available to the
hospital, of providers offering the services requested.
(4) Visiting. The hospital shall develop and
implement written policies and procedures regarding visiting that:
(i) do not unreasonably restrict fathers or
other primary support person(s) from visitation to the mother during the
recovery period;
(ii) promote
family bonding by allowing regular visitation for the newborn's siblings in a
manner consistent with safety and infection control; and
(iii) permit visitations by other family
members and friends in a manner consistent with efficient hospital operation
and acceptable standards of care.
(5) Discharge planning. The discharge of
mother and newborn shall be performed in accordance with section
405.9 of this Part. In addition,
prior to discharge, the hospital shall determine that:
(i) sources of nutrition for the infant and
mother will be available and sufficient and if this is not confirmed, the
attending practitioner and an appropriate social services agency shall be
notified;
(ii) follow-up medical
arrangements, consistent with current perinatal guidelines and recommendations,
have been made for mother and newborn;
(iii) the mother has been informed of
community services, including the Special Supplemental Nutrition Program for
Women, Infants and Children (WIC), and shall make referrals to such community
services as appropriate;
(iv) the
mother has been instructed regarding normal postpartum events, care of breasts
and perineum, care of the urinary bladder, amounts of activity allowed, diet,
exercise, emotional response, family planning, resumption of coitus and signs
of common complications;
(v) the
mother has been advised on what to do if any complication or emergency
arises;
(vi) the newborn has had a
documented and complete physical examination and verification of a passage of
stool and urine;
(vii) the means of
identification of mother and newborn are matched. If the newborn is discharged
in the care of someone other than the mother, the hospital shall ensure that
the person or persons are entitled to the custody of the newborn; and
(viii) the newborn is stable; sucking and
swallowing abilities are normal. Routine medical evaluation of the neonate's
status at two to three days of age shall have been conducted or arranged.
Newborn screening shall be conducted at time of discharge, provided discharge
is greater than 24 hours after the birth, or between the third and fifth day of
life, whichever occurs first, in accordance with Part 69 of this
Title.
(g)
High-risk neonatal care.
(1) Each
hospital providing Level I, II or III perinatal care services shall enter into
a perinatal affiliation agreement with its designated RPC in accordance with
Part 721 of this Title. Level I and II hospitals may also enter into transfer
agreements in accordance with Part 721 of this Title with Level III hospitals.
(i) The perinatal affiliation agreements and
transfer agreements shall include provisions for standardized risk assessment
based on generally accepted standards of practice, stabilization and
resuscitation of newborns as necessary, newborn screening in accordance with
Part 69 of this Title, consultation, patient transport, transfer of maternal
and newborn records and any other features needed to ensure prompt and
efficient transport of newborns that minimize risks and provide the newborn
with needed services.
(ii) Unless
medically contraindicated, mothers shall be permitted to accompany distressed
newborns to receiving perinatal care facilities.
(iii) The perinatal affiliation agreements
and transfer agreements shall provide for the return of the distressed newborn
to the sending hospital when the condition has been stabilized and return is
medically appropriate.
(iv) If
transfer necessitates separating the mother and newborn, mothers who have
chosen to breastfeed should be encouraged to maintain lactation and breast milk
should be available to the newborn.
(2) Placement in nurseries.
(i) Healthy newborns shall be placed in a
normal newborn nursery. If a newborn in a normal newborn nursery is removed
temporarily from the perinatal service for any reason, the newborn may be
returned to the normal newborn nursery only if infection control measures
established by the hospital have been followed.
(ii) Newborns requiring specialized care
shall be placed in a NICU and hospitals shall develop and implement protocols
for all phases of treatment of such newborns. Newborns who are delivered in
perinatal care services that are not capable of providing all necessary care
and services shall be transferred to perinatal care services at hospitals that
can meet the newborns' needs.
(h)
Neonatal intensive care
services.
(1) Neonatal intensive care
services shall be provided by Level II, Level III and RPC perinatal care
hospitals.
(2) 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 services
after consultation with that service has established that the infant might
benefit from such transfer.
(ii)
Level III perinatal care services and RPCs shall consult with the hospital's
bioethical review committee which shall assist the service and provide guidance
to staff and families in the resolution of issues affecting the care, support
and treatment of severely ill, injured, or handicapped infants with
life-threatening conditions. The committee:
(a) shall consist of such members of the
medical staff, nursing staff, social work staff and administration as
designated by the governing body and such other community-based individuals
with experience in bioethical matters as may be chosen by the governing
body;
(b) shall operate in
accordance with written policies and procedures developed by the hospital. Such
policies shall establish the protocols for organization and functioning of the
committee and scope of responsibility for specified cases as well as
development of general review policies governing bioethical matters. The
hospital shall:
(1) ensure that the parents
are fully advised regarding the infant's condition, prognosis, options for
treatment, likely outcomes of such treatment and options, if any, for the
discontinuance of heroic life maintenance efforts; and
(2) ensure that any decision by competent
parents to continue life-sustaining efforts is implemented by the hospital;
and
(c) shall, in
conjunction with the attending physician(s), child protective services, the
medical staff and the governing body, recommend that the hospital obtain an
appropriate court order to undertake a course of treatment, in all cases when
in the judgment of the committee:
(1) the
parents do not have the capacity to make a decision; or
(2) the parents' decision on a course of
action is manifestly against the infant's best
interest.