Section 130.640 - Level IIA and IIIB: Community-based Maternal and Newborn Service with a Special Care Nursery(A)Level IIA Service. Level IIA capabilities include the management of pregnancies of 34 weeks gestation or greater, and the management of pregnancy complications not requiring the facilities and resources of Level IIB or Level III services. Level IIA capabilities include the care and management of the stable to moderately ill newborn, well newborns, premature infants and infants who require special care services (including retro-transferred infants). A service shall be eligible to apply for designation as a Level IIA service with a special care nursery if one of the following conditions is met:
(1) the service has a minimum of 1,500 births per year in any one of the past three years prior to the initiation of the service designation request; or(2) the service has satisfactorily demonstrated to the Department that a minimum volume of 1,500 births per year will be reached in the next three years; or(3) the service has satisfactorily demonstrated to the Department that the hospital meets Level IIA quality and competency requirements and therefore the designation is warranted. Following the designation, a Level IIA service shall maintain a minimum volume of 1,500 births.(B)Level IIB Service. Level IIB capabilities include the care and management of pregnancies of 32 weeks gestation or greater, and the management of pregnancy complications not requiring the facilities and resources a Level III service. Level IIB capabilities include the care and management of the stable to moderately ill newborn, well newborns, premature infants and infants who require special care services (including retro-transferred infants). Level IIB service includes the care of infants requiring Continuous Positive Airway Pressure (CPAP), in compliance with guidelines established by the Department. A service shall be eligible to apply for designation as a Level IIB service with special care nursery if one of the following conditions is met:
(1) the service has a minimum of 2,000 births per year in any one of the past three years prior to the initiation of the service designation request; or(2) the service has a minimum volume of 2,500 births for each of the two years after the designation as a Level IIA services; or(3) the service has satisfactorily demonstrated to the Department that the hospital meets Level IIB quality and competency requirements and therefore the designation is warranted. Following the designation, a Level IIB service shall maintain a minimum volume of 2,000 births.(C) The Level IIA or IIB Community-based Maternal-Newborn Service shall meet the requirements of a Level I service and those requirements contained in 105 CMR 130.601 through 130.630 and 130.640(D) through (E), unless otherwise specified.(D)Maternal Service.(1)Administration and Staffing. (a)Nursing. 1. The hospital shall designate a registered nurse who has responsibility and accountability for the 24 hour nursing management of the Level II service. At a minimum, such nurse shall be prepared at the baccalaureate level and have additional education in the specialty area. She or he shall also have at least two years experience in the specialty area and meet the qualifications for the management position as defined by hospital policy.2. In a Level IIA service, a registered nurse educator, prepared at the baccalaureate level (master's preferred) shall have dedicated responsibility for coordinating and providing education activities to enhance staff knowledge of relevant procedures and technological advances for staff of the maternal and newborn service.3. In a Level IIB service, at a minimum a full time master's prepared clinical nurse educator, preferably a specialist with clinical experience in perinatology or neonatology or a neonatal nurse practitioner shall be available with dedicated responsibility for coordinating education for maternal and newborn staff.(b) A licensed social worker with experience in maternal and child health shall be available to provide services to mothers and families.(2)Services. Each Level II Maternal Service shall provide the following:(a) Radiology, in-house, 24 hours a day.(b) Clinical laboratory services including microchemical fetal blood sample monitoring, in house, 24 hours a day.(c) Ultrasound and amniocentesis services in-house, 24 hours a day.(d) Specialty services for the mothers including, but not limited to, general surgery, cardiology, urology, internal medicine, hematology and neurology.(e) Access to genetics counseling.(3)Policies and Procedures. Each Level II Maternal Service shall have written policies and procedures as required by 105 CMR 130.601 through 130.628 and, in addition, the following: (a) n organized plan for a team approach to deliveries that requires the presence of a pediatrician and an anesthesiologist in the delivery room and properly defines their responsibilities. The hospital's perinatal committee shall establish policies, definitions, and conditions of delivery requiring a team approach.(b) Other policies and procedures as deemed appropriate by the hospital perinatal committee. Such policies shall be submitted to the Department upon request.(E)Special Care Nursery.(1)Administration and Staffing. (a) A neonatologist certified by the American Board of Pediatrics in neonatology shall be designated the medical director of the Special Care Nursery. A pediatrician meeting the requirements of 105 CMR 130.640(E)(1)(b) shall be designated to act in the absence of the director.(b) A neonatologist certification in neonatology by the American Board of Pediatrics shall be available on-call 24 hours a day.(c) The hospital shall designate a registered nurse who has responsibility and accountability for the 24 hour nursing management of the Special Care Nursery service. At a minimum, such nurse shall be baccalaureate-prepared and have additional education in the neonatology specialty area. She or he shall have at least two years experience in the specialty area and meet the qualifications for the management position as defined by hospital policy.(2)Special On-site Staffing Requirements. Each hospital providing special care nursery services shall provide on-site coverage 24 hours a day by either a neonatologist, pediatrician or a physician who meets the requirements of 105 CMR 130.640(E)(2)(a) or neonatal nurse practitioner who meets the requirements of 105 CMR 130.640(E)(2)(b), who shall be immediately available to the special care nursery and the delivery room.(a)Pediatricians. A pediatrician qualified to provide on-site coverage in the special care nursery shall be either a pediatric resident who, at a minimum, has completed the second year of post-graduate residency training with at least two months neonatal intensive care unit rotations or a pediatrician. Pediatricians shall meet the hospital's requirements for special care nursery privileges. Pediatric residents shall meet criteria for special care nursery coverage established by the Director of the special care nursery. At a minimum, criteria for privileges and coverage shall include the specific clinical skills to provide emergency newborn resuscitation in the delivery room and essential special care nursery skills such as intubation, emergency pneumothorax management, umbilical artery catheterization, and drawing arterial blood gases. Before assignment to provide on-site coverage, pediatricians and residents shall successfully complete the American Heart Association/American Academy of Pediatrics neonatal resuscitation course (or an equivalent).(b)Neonatal Nurse Practitioner.1. A neonatal nurse practitioner qualified to provide on-site coverage in the special care nursery shall:a. be certified as a neonatal nurse practitioner by a nationally recognized organization; and b. be authorized to practice as an advanced practice registered nurse by the Massachusetts Board of Registration in Nursing.2. Before assignment to provide on-site coverage, each neonatal nurse practitioner shall successfully complete the American Heart Association/ American Academy of Pediatrics neonatal resuscitation course (or an equivalent).3. Neonatal nurse practitioners shall be credentialed through the hospital's nursing department and medical staff. The neonatal nurse practitioner shall engage in prescriptive practice in accordance with written guidelines mutually developed and agreed upon between the nurse practitioner and the physician supervising the nurse practitioner's prescriptive practice. The written guidelines will conform to 244 CMR 4.07(2)(b). Neonatal nurse practitioners shall also meet the criteria for delivery room and special care nursery coverage established by the director of the special care nursery. Criteria shall include the skills necessary to provide emergency care to newborns as outlined in 105 CMR 130.640(E)(3)(a).4. The nurse practitioner providing Level II coverage shall have at least one year's recent experience functioning as a neonatal nurse practitioner on a service that provides high risk obstetrical and neonatal intensive care unit services.5. Neonatal nurse practitioners shall be part of a team providing patient care and not retained only to provide off hour or holiday coverage at the level II service. The schedule for coverage of the delivery room and special care nursery shall reflect that pediatricians and neonatal nurse practitioners who are members of the team share responsibility for covering all shifts and collaborate in the ongoing care of infants and their families and in professional education activities.6. There shall be written policies and procedures outlining the specific criteria for summoning pediatrician or neonatologist back-up coverage for consultation and for on-site assistance in the delivery room and special care nursery.(3)Services. Each Level IIA or IIB Special Care Nursery shall provide the following, unless otherwise specified: (a) Provision of a neutral-thermal environment.(b) Continuous and long-term oxygen administration via nasal cannula and hood, including oxygen saturation monitoring.(c) Pharmacological treatment of apnea of prematurity.(d) Capabilities to insert and maintain intravenous therapy for hydration and medication administration, in house, 24 hours a day.(e) Umbilical artery and venous catheter insertion and maintenance.(f) Continuous electronic cardio-respiratory monitoring.(g) Blood transfusion capability (exchange transfusion optional).(h) Naso-gastric, oro-gastric and oro-jejunal feedings.(i) Parenteral nutrition.(j) Access within the facility or through arrangement with Level III facilities to subspecialty services or consultation with pediatric surgery, neurology, cardiology and genetics.(k) CPAP services in compliance with guidelines established by the Department.(4)Policies and Procedures for Transfer.(a) In a Level IIA service a mechanical ventilator or CPAP may be initiated and used in a Special Care Nursery prior to a transfer to a Level III service when the Medical Director of the Special Care Nursery approves such use and when all of the following conditions are met:1. A neonatologist remains immediately available in the hospital at all times.2. A respiratory therapist with experience in neonatal ventilation remains at the infant's bedside at all times.3. The Special Care Nursery is arranging for transport of the infant to the Level III service.4. The mechanical ventilator is used only while the infant is awaiting the transport.(b) In a Level IIB service a mechanical ventilator may be initiated and used in a Special Care Nursery prior to a transfer to a Level III service when the Medical Director of the Special Care Nursery approves such use and when all of the following conditions are met: 1. A neonatologist remains immediately available in the hospital at all times.2. A respiratory therapist with experience in neonatal ventilation remains at the infant's bedside at all times.3. The Special Care Nursery is arranging for transport of the infant to the Level III service.4. The mechanical ventilator is used only while the infant is awaiting the transport. (5)Other Policies and Procedures. The Special Care Nursery shall have written policies and procedures for the following:(a) Orientation and ongoing education for registered nurses including the theoretical framework and skills required to practice in the Special Care Nursery.(b) Other policies and procedures as deemed appropriate by the hospital perinatal committee.(6)Records. In addition to meeting the requirements for records contained in 105 CMR 130.627(B), the record of a newborn treated in a Special Care Nursery shall also contain documentation of the following: (a) Diagnostic and treatment modalities.(b) Family-infant interactions.(c) Parents' understanding of infant's condition, progress and treatment.(d) Parent education and involvement in both normal and specialized care-giving.(e) Where indicated, the plan for and patient response to infant stimulation program.(f) Referrals to community agencies such as parent support groups, visiting nurse associations and early intervention programs.(7)Environment and Equipment. The Special Care Nursery shall contain, at a minimum, the following equipment and be responsible for appropriate maintenance, per hospital policy: (b) Cardio-respiratory monitors with high/low alarm.(e) Oxygen humidification and warming system.(g) Umbilical artery/vein catheterization equipment.(h) Neonatal resuscitation medications and equipment as described by the American Academy of Pediatrics Neonatal Resuscitation Program guidelines.(8)Construction and Arrangement of Special Care Nursery. The construction and arrangement of the Special Care Nursery shall permit immediate observation and accessibility of infants to personnel. Total nursery space, exclusive of anteroom, shall provide an average floor space of 50 square feet for each incubator or bassinet.Amended by Mass Register Issue 1343, eff. 4/7/2017.