105 CMR 130.616
Administration and Staffing
(A) Perinatal Committee.
Each maternal and newborn service shall establish a
multidisciplinary perinatal committee or its equivalent responsible for developing a coordinated
approach to maternal and newborn care
(2) Written Collaboration and Transfer Agreements.
(1) Each hospital with a maternal and newborn service that is not designated as a Level III
service shall develop a written collaboration/transfer agreement with at least one primary
Level III maternal and newborn service. The agreement shall include provisions for
consultation; guidelines for maternal and newborn transfer, including provision of relevant
medical information and ongoing patient-centered communications before, during and after
transport or retro-transfer; provision for professional educational offerings; and take into
consideration unusual circumstances, such as lack of available bed or patient request.
(2) Collaboration/transfer agreements between hospitals that regularlytransfer patients shall
include provisions for monitoring the quality of care provided to transfers with a focus on
outcomes.
(3) A maternal and newborn center located close to a level III service in another state may
develop an agreement with that center, provided the center meets the applicable regulations
for that state.
(C) Administrative Policies. Each maternal and newborn service shall develop and implement
written administrative policies that include, but are not limited to, previously discharged or retro-
transferred infants and antenatal patients, and include the following:
(1) on-site availability 24 hours a day, of at least one professional, licensed staff member
who is a provider of neonatal resuscitation and trained by a recognized program, such as the
American Academy of Pediatrics’ Neonatal Resuscitation Program (NRP).
(2) The maternal and newborn service shall be self-contained and discrete from other
hospital services and be situated so as to accommodate patient flow without passing through
other functional areas of the hospital. There shall be limited access to the service.
(D) Patient Care Policies. Each maternal and newborn service shall develop and implement
written patient care policies and procedures, supported by evidence based resources, which
include, but are not limited to:
(1) Pain Management;
(2) Care of the Newborn. Each maternal and newborn service shall develop and implement
written patient care policies and procedures, supported by evidence based resources, which
include, but are not limited to:
(a) Apgar scoring.
(b) Thermoregulation, including skin-to-skin contact when appropriate.
(c) Eye prophylaxis for ophthalmia neonatorum.
(d) Collection of cord blood sample.
(e) Vitamin K administration.
(f) Infant security policies and procedures developed in conjunction with the hospital’s
security and pediatric departments. At a minimum, the policy shall address:
1. a process for identifying the newborn at the time of delivery;
2. use of an acceptable identification system;
3. procedure for rebanding an infant;
4. identification of individuals who can remove a newborn from the nursery;
5. visitation policies outlining who is allowed to visit and when; and
6. a plan for educating parents regarding the security procedures.
(g) Promotion of parent-newborn contact.
(h) Infant feeding (including flexible schedule per parent’s request), output
measurement and skin-to-skin care.
(i) Comfort measures and reduction of pain and trauma during invasive procedures.
(j) Complete physical examination by a physician or neonatal nurse practitioner within
24 hours of birth or upon admission, including infants who are retrotransferred.
(k) Stabilization and management of the infant requiring transfer including the
opportunity for the family to see and touch the infant before transfer.
(l) Hearing screening through the Universal Newborn Screening Program.
1. Prior to the hearing screening of a newborn infant, the hospital or birth center
shall include information explaining the importance of newborn hearing screening
and follow up in materials distributed to parents or guardians in accordance with the
hospital’s established culturally and linguistically appropriate policies and
procedures.
2. Each birth hospital and birth center shall ensure a hearing screening is performed
on all newborn infants before the newborn infant is initially discharged to home in
accordance with the hospital’s established policies and procedures.
a. If a newborn infant is transferred directly from the birth hospital or birth
center to another hospital, the responsibility for screening lies with the hospital
from which the infant is initially discharged to home.
b. By three months of age, an infant shall receive hearing screening. If an infant
cannot be screened by the age of three months due to delayed physiological
development or physiological instability as a result of illness or premature birth,
the infant shall be screened prior to discharge and as early as physiological
development or stability will permit reliable screening.
3. Such screening shall not be performed if the parent or guardian of the newborn
infant objects to the screening based upon sincerely held religious beliefs.
4. If an infant is not successfully screened or missed a screening prior to discharge,
the birth hospital or birth center shall contact a Department approved screening center
to make an appointment for a screening.
5. The birth hospital or birth center shall inform, orally and in writing, a parent or
guardian of the newborn infant if the infant was not successfully screened or missed
a screening. This information shall also be provided in writing to the newborn
infant’s primary care physician and the Department through its electronic birth
certificate system or such mechanism as specified by the Department, and in
accordance with the hospital’s established policies and procedures.
a. Such notice shall occur prior to discharge whenever possible, but in any case
no later than ten days following discharge.
b. The birth hospital or birth center so informing the parent or guardian and
physician shall provide written information to the parent or guardian and
physician regarding appropriate follow-up for an infant who missed a screening
or was not successfully screened in accordance with the hospital’s established
policies and procedures.
6. If an infant did not pass the hearing screening, the birth hospital or birth center
shall contact a Department approved diagnostic test center to make an appointment
for a diagnostic test.
7. The birth hospital or birth center shall inform, orally and in writing, a parent or
guardian of the newborn infant if the infant did not pass the screening. This
information shall also be provided in writing to the newborn infant’s primary care
physician as well as to the Department through its electronic birth certificate system
or such mechanism as specified by the Department and in accordance with the
hospital’s established policies and procedures.
a. Such notice shall occur prior to discharge whenever possible, but in any case
no later than ten days following discharge.
b. The birth hospital or birth center so informing the parent or guardian and
physician shall provide written information to the parent or guardian and
physician regarding appropriate follow-up for an infant who did not pass the
screening.
8. Screening Protocols.
a. The birth hospital or birth center shall designate a program director who is
responsible for the provision of newborn infant hearing screening services. The
program director shall be an audiologist, neonatologist, pediatric
otolaryngologist, neonatal or perinatal nurse, or pediatrician. The program
director may delegate duties related to the oversight of the hearing screening
service to appropriately trained staff.
b. A licensed audiologist shall oversee the provision of screening services and
shall train the persons performing the screening.
c. Each birth hospital and birth center shall develop and update accordingly a
protocol for newborn hearing screening. The protocol shall identify, at minimum,
the necessary training and supervision of staff, maintenance of appropriate
equipment, screening methods, infection control procedures, documentation and
communication procedures, methods for ensuring appropriate follow-up for
newborns that did not pass the test or were not screened, quality review and data
reporting as required by the Department.
(m) Newborn blood screening required by statute.
(n) Appropriate administration of hepatitis B vaccine and hepatitis B immune globulin
to all infants according to the recommendation of the Centers for Disease Control
Advisory Committee on Immunization Practices and the Massachusetts Immunization
Program.
(o) Screening for critical congenital heart disease with pulse oximetry or other test
approved by the Department as set forth in guidelines, unless the parent or guardian of
the infant has objected to the screening based on sincerely held religious beliefs.
(3) Admission and/or treatment of patients who have delivered outside of the maternal and
newborn service or hospital, including home births.
(4) Use of the maternity service for gynecology patients. Gynecology patients shall not be
routinely cared for on a maternity unit. However, the hospital shall develop and implement
appropriate policies and procedures in the event that it is necessary for gynecology patients
to be placed on the unit.
(5) Protocols to ensure that the care of obstetrical patients hospitalized for medical/surgical
conditions is coordinated, including consultation with obstetrical services medical and
nursing staff.
(6) Policies for the safe and secure storage and handling of infant feedings, formula and
breast milk, including policies to ensure the correct labeling and identification of all infant
feeding.
(E) Quality Assurance and Education Program.
(1) Each maternal and newborn service shall have an ongoing documented, evidence-based,
quality assurance program including problem identification, action plans, evaluation and
follow-up. A multi-disciplinary approach shall be required.
(2) The quality assurance program shall include an annual Hearing Screening Program
Evaluation of critical performance data, including but not limited to, number of live births,
number of infants screened, number of infants who passed the screening, number of infants
who did not pass the screening in the right ear, number of infants who did not pass the
screening in the left ear, number of infants who did not pass the screening in both ears,
number of infants who missed screening or were unsuccessfully screened, the number of
infants referred for diagnostic testing, and the number of parents or guardians who refused
screening.
(F) Nurse Staffing. The Maternal and Newborn service shall meet the following requirements:
(1) A registered nurse who has successfully completed a recognized program in neonatal
resuscitation, such as the Neonatal Resuscitation Program (NRP), shall be present during the
delivery. A second registered nurse shall be immediatelyavailable as additional support until
the mother and infant are stabilized.
(2) A registered nurse shall be on duty in each patient care unit on every shift. The hospital
shall ensure that all licensed nursing staff caring for maternal and newborn patients have
demonstrated current competency in providing care in the specialty area. All licensed
nursing staff shall receive orientation and periodic in-service education related to the current
best practices for maternal and newborn care including training or documented skill in at
least the following areas:
(a) Evaluation of the condition of the mother, fetus and newborn.
(b) Assessment of risk during the labor, delivery, recovery and postpartum periods.
(c) Fetal assessment modalities including use of electronic fetal monitor, auscultation
tools, interpretation of fetal heart-rate patterns and initiation of appropriate nursing
interventions for non-reassuring patterns (for nurses caring for pregnant women).
(d) Nursing management of emergency situations that specifies communication and
decision-making responsibilities and chain of command.
(e) Adult and newborn resuscitation.
(f) Immediate care and assessment of the newborn.
(g) Family-centered care that is culturally and linguistically appropriate.
(h) Support of the normal processes of labor and birth.
(i) Mother and infant security.
(j) Initiation and support of lactation.
(3) The licensed nursing staff shall receive documented retraining in adult and neonatal
cardio-pulmonary resuscitation every two years and mock code drills every year. Each
maternal and newborn service shall provide licensed nursing staff with continuing education
in specialty areas of the service.
(4) The hospital shall plan, develop and budget its nurse staffing pattern for the maternal
and newborn service using data from a patient classification system acceptable to the
Department. If a classification system is not used, the hospital shall apply nationally
recognized staffing standards acceptable to the Department based upon the facility’s case-
mix and volume.
(G) Lactation Care and Services. Each hospital shall deliver culturally and linguistically
appropriate lactation care and services by staff members with knowledge and experience in
lactation management. At a minimum, each hospital shall provide every mother and infant
requiring advanced lactation support with ongoing consultation during the hospital stay from an
International Board Certified Lactation Consultant (IBCLC) or an individual with equivalent
training and experience. An educational program of lactation support for maternal and newborn
staff shall be offered by qualified staff.