Section 130.650 - Level III Maternal and Newborn Service or a Freestanding Pediatric Hospital with Neonatal Subspecialty Services(A)Level III Service. The Level III maternal and newborn service has the capabilities to provide care for stable to severely ill newborns, well newborns, premature infants, and infants who require neonatal intensive care services. The maternal service has the capability to manage complex maternal conditions with the expertise of a Critical Care Obstetrics Team.(B) A service shall be eligible for designation as a Level III service with a neonatal intensive care nursery if one of the following conditions is met: (1) the service has a minimum of 2,000 births per year in any one of the past three years; or(2) the service has satisfactorily demonstrated to the Department that a minimum volume of 2,000 births per year will be reached in the next three years; or(3) the service has satisfactorily demonstrated that the percent of low birth weight infants (< 2,500 grams) delivered is no less than 10% of the annual births.(C) The Level III service shall meet the requirements of a Level I, IIA, and IIB service, and those requirements contained in 105 CMR 130.601 through 130.628 and, in addition, the requirements set forth in 105 CMR 130.650(D) and (E).(D)Maternal Service .(1)Administration and Staffing. (a) A physician certified by the American Board of Obstetrics and Gynecology with a subspecialty(special competency) in maternal-fetal medicine shall be designated medical director of the maternal service. This obstetrician shall collaborate with the neonatologist responsible for the neonatal intensive care unit in the medical management of the maternal and newborn service.(b) An obstetrician with full privileges shall be available in-house 24 hours a day.(c) At a minimum, a second obstetrician or obstetrician in training who has completed the second year of post-graduate residency shall be immediately available to the unit, inhouse, 24 hours a day.(d) The hospital shall designate a registered nurse who has responsibility and accountability for the 24 hour a day nursing management of the Level III Maternal Service. At a minimum, such nurse shall be master's-prepared and have additional education in the maternal specialty area. She or he shall also have at least five years of clinical experience, two of which are in the specialty area, and, in addition, meet the qualifications for the position as defined by hospital policy.(e) Qualified registered nurses shall be on duty to care for maternal patients 24 hours a day. The team of nurses shall demonstrate competencies in critical care as required by hospital policies and be Advanced Cardiac Life Support certified or have equivalent training and experience.(f) A dietician registered by the Commission on Dietetic Registration with expertise in both normal and high risk maternal and newborn nutritional needs and with access to neonatal nutritional resources shall be available seven days a week.(2)Services. The Level III Maternal Service shall provide the following: (a) Anesthesia, in-house, 24 hours a day.(b) Radiology and imaging, in-house, 24 hours a day.(c) Clinical laboratory services including on-unit capabilities for microchemical fetal blood sample monitoring 24 hours a day.(d) Access within the facility or through referral to another Level III facility to intrauterine transfusions and surgery.(e) Adult subspecialty services including general surgery, thoracic surgery, neurosurgery, cardiology, urology, internal medicine, hematology, neurology, genetics and psychiatry.(f) Intensive care unit services and invasive cardio-vascular monitoring.(3)Policies and Procedures. In addition to the policies and procedures required pursuant to 105 CMR 130.601 through 130.628, a Level III service shall develop policies and procedures for the following: (a) Admission and transfer criteria.(b) Maternal/fetal research.(c) Other policies and procedures as deemed appropriate by the hospital perinatal committee. Such policies and procedures shall be submitted to the Department upon request.
(E)Neonatal Intensive Care Unit. The Neonatal Intensive Care Unit shall meet the requirements of a Level I, IIA, IIB, and III service, as well as those requirements contained in 105 CMR 130.601 through 130.628 and 130.650(D) and (E). (1)Administration and Staffing. (a) A board-certified neonatologist shall be designated the medical director of the Neonatal Intensive Care Unit. The medical director or his or her designee shall be available on-call 24 hours a day.(b) A neonatologist shall be available in-house 24 hours a day.(c) At a minimum, a pediatrician or a pediatrician-in-training who has completed the second year of post-graduate residency shall be present in-house and immediately available to the unit, 24 hours a day.(d) A nurse designated by the hospital shall be responsible for the 24 hours a day nursing management of the neonatal intensive care service. At a minimum, this nurse shall be masters-prepared and have experience and advanced education in caring for sick newborns. She or he shall have at least five years of clinical experience, two of which are in the specialty area, and, in addition, meet the qualifications for the position as defined by hospital policy.(e) Qualified registered nurses shall be on duty to care for newborns 24 hours a day. The team of nurses shall demonstrate competencies in critical care as defined by hospital policy and be Neonatal Resuscitation Program (NRP) certified.(f) A freestanding pediatric hospital with a neonatology subspecialty shall meet the requirements for a nurse educator stipulated in 105 CMR 130.640(D)(1)(a).(g) A masters-prepared licensed social worker with experience in assessment of perinatal patients (mother/infant dyad), education, discharge planning, community follow-up programs, referrals and home care arrangements shall be available as needed to meet patient needs.(h) A respiratory therapist trained in the neonatology specialty area shall be available to the unit 24 hours a day.(i) A lactation consultant shall be available seven days a week. Lactation consultants shall have training and experience in providing care and services to infants with special needs and their families.(2)Services. The Neonatal Intensive Care Unit shall be located within either a hospital with Level III Maternal and Newborn Service or a Freestanding Pediatric Hospital with Neonatal Subspecialty Services. The Level III Neonatal Intensive Care Unit shall provide the following:
(a) Access to emergency transport team for transferring sick newborns from the birth hospital to the neonatal intensive care unit.(b) Ventilatory assistance and/or complex respiratory management including high-frequency ventilation.(c) Capability of continuous intravenous administration of vasopressor agents.(d) Insertion and maintenance of all types of venous and arterial lines.(e) Nitric oxide therapy.(f) Exchange transfusions.(g) Cardio-respiratory monitoring including oxygen saturation monitoring.(h) Complex nutritional and metabolic management including total parenteral nutrition. (i) Full range of emergency pediatric radiology and subspecialty services available 24 hours a day.(j) Full range of laboratory services including microchemistry and full service blood bank available 24 hours a day.(k) Access to emergency surgical interventions in the newborn (or written agreements with other institutions providing subspecialty surgical procedures) available 24 hours a day.(m) Access to pediatric subspecialty consultation and services including surgery, neurology, cardiology, gastroenterology, infectious disease, hematology and genetics available 24 hours a day.(n) Availability of developmental consultation, including occupational and physical therapies.(o) Continuous involvement of parents in infant's care and opportunity for mothers to room-in for pre-discharge education in caring for the infant.(p) Crisis-oriented support and ongoing psychosocial services including social work service and the availability of psychiatric consultation for the parents. (Provision for parent support group is recommended.)(q) Transport capabilities to return patients to a hospital with a Level I or II service.(r) Ethics committee for ongoing review of complex patient care issues with focus on parental involvement in decision making.(s) Professional education program, including educational offerings to collaborating community hospitals.(t) Parent education appropriate to meet the needs of the infant and family.(3)Policies and Procedures. The neonatal intensive care unit shall have written policies and procedures for the following:(a) Orientation and ongoing education for registered nurses in the theoretical framework and skills required to practice in the NICU.(b) Emergency transport of infants from collaborating hospitals. These policies shall require the presence of a physician, physician assistant with neonatology training or neonatology specialty-trained nurse on the transport team and access to telephone consultation with a neonatologist.(c) Newborn pain and substance exposure management.(d) Each hospital with a Level III maternal and newborn service shall develop and maintain quality improvement initiatives including participation in the Vermont Oxford Network's Very Low Birth Weight Database, and shall make Vermont Oxford Network data reports available to the Department upon request.(e) Other policies and procedures as determined by the hospital perinatal committee or the multidisciplinary neonatal intensive care committee.(4)Records. In addition to meeting the requirements for records contained in 105 CMR 130.627(B), the newborn's record shall also contain documentation of the following: (a) Diagnostic and treatment modalities.(b) Family-infant interactions.(c) Psychosocial evaluation.(d) Staff-parent communication and parental response to the infant's condition.(e) Parent education and involvement in both normal and specialized care-giving.(f) The process used to make decisions where ethical questions are raised, including parental involvement in the process.(g) Application of research protocols in the care of the infant.(h) Where need identified, a plan for and patient response to positive infant stimulation program.(i) Written discharge plans with referrals to community agencies such as parent support groups, visiting nurse associations and early intervention programs.(5)Environment and Equipment. The Neonatal Intensive Care Unit shall contain at a minimum the following equipment and be responsible for appropriate maintenance per hospital policy:(a) Sleeping space shall be provided for parents who spend extended periods of time with the infant.(b) A consultation/demonstration room for private discussions shall be located convenient to the neonatal intensive care unit.(c) Availability of breastfeeding pump room.(d) Percutaneous oxygen monitor.(e) Arterial and venous catheterization equipment.(f) Ventilators with heated humidity and alarm systems(g) Transducers for invasive cardiac monitoring.(h) Transport isolette(s).(i) Separate nutrition support area.Amended by Mass Register Issue 1343, eff. 4/7/2017.