Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 130.000 - Hospital Licensure
Subpart D - SUPPLEMENTARY STANDARDS: PARTICULAR SERVICES
Section 130.630 - Level I - Community-based Maternal and Newborn Service

Universal Citation: 105 CMR 130.000 MA Code of Regs 130.630

Current through Register 1531, September 27, 2024

The Level I capabilities include the management of uncomplicated pregnancies and the management of pregnancy complications not requiring the facilities and resources of Level IB, IIA, IIB or Level III services. The Level 1 service provides for the care and management of well newborns, stable infants born at 35 weeks gestation, including stable retro-transferred infants not needing Level IB, IIA, IIB or III services.

The Level I Service shall meet all of the General Requirements for Maternal and Newborn Services contained in 105 CMR 130.601 through 130.628 and, in addition, the following:

(A) Administration and Staffing.

(1) An obstetrician certified by the American Board of Obstetrics and Gynecology shall be designated as medical director of the maternal service. The medical director or his or her designee shall be available on-call 24 hours a day.

(2) A physician certified by the American Board of Pediatrics and experienced in the care of newborns shall be designated as medical director of the newborn service. The medical director or his or her designee shall be available on-call 24 hours a day.

(3) The medical directors of the maternal service and the newborn service shall collaborate in the overall medical management of the maternal and newborn service.

(4) An obstetrician with full privileges shall be available on-call 24 hours a day.

(5) A pediatrician, family practitioner or a neonatal nurse practitioner with full privileges shall be available on-call 24 hours a day.

(6) A registered nurse designated by the hospital shall be accountable for the 24 hour nursing management of the Level I service. At a minimum, this nurse shall be baccalaureate prepared (master's preferred) and have at least two years experience in the care of stable newborns.

(7) A registered nurse educator, prepared at the baccalaureate level, shall have dedicated responsibility for coordinating and providing educational and training activities to enhance staff knowledge of relevant procedures and technological advances for staff of the maternal and newborn service.

(8) Anesthesiologists shall be available in-house or on-call such that emergency cesarean deliveries can be started within 30 minutes of the recognition of the need for the procedure.

(B) Services. The Level I Maternal and Newborn Service shall provide the following services:

(1) Social risk assessment and social work services provided by a licensed social worker(s) with experience in social assessment of and planning for perinatal patients (mother/infant dyad), as determined appropriate by the patient(s) health care team. These services may be provided by the hospital social service department or through contracted services with public or private social service agencies.

(2) Nutritional consultation by a dietician registered by the Commission on Dietetic Registration and experienced in maternal and newborn nutritional needs available seven days a week, as determined appropriate by the patient(s) health care team.

(3) Medical risk assessment and early identification of high-risk maternal, fetal and newborn patients, including access to or consultation with subspecialty services 24 hours a day.

(4) Continuous internal and external electronic fetal monitoring and auscultation.

(5) Blood for transfusions including O negative and fresh frozen plasma 24 hours a day.

(6) Respiratory therapists shall be available on call 24 hours a day.

(7) Radiology services, including portable x-ray and ultrasound on-call 24 hours a day.

(8) Clinical laboratory services, including microchemistry, on-call 24 hours a day.

(9) Ongoing care, monitoring, stabilization, and resuscitation, available 24 hours a day for infants born in-house and for retrotransfers.

(10) Registered pharmacist services, available at a minimum by telephone consultation, with access to, at minimum, neonatal, pediatric and maternal pharmacological resources, and 24-hour access to emergency drugs.

(11) Emergency cesarean surgical birth within 30 minutes of the decision to perform the procedure.

(B) Policies and Procedures. The Level I Maternal and Newborn Service shall develop those policies and procedures listed in 105 CMR 130.601 through 130.628 and other policies and procedures as deemed appropriate by the hospital perinatal committee. Such policies shall be submitted to the Department upon request.

(C) Level IB Service Designation. The services capabilities include the management of uncomplicated pregnancies and the management of pregnancy complications not requiring the facilities and resources of Level IIA, IIB or Level III services. Provides for the care and management of well newborns, stable infants born at; 35 weeks gestation, including stable retro-transferred infants not needing Level IIA, IIB or III services. A Level I service may be designated as a Level IB service with a continuing care nursery service if the requirements of 105 CMR 130.630(E)(1) through (4) are met 24 hours a day, seven days a week:

(1) Administration and Staffing.
(a) A physician certified by the American Board of Pediatrics with experience in the care of special care newborns shall be designated as the medical director of the Level IB Continuing Care Nursery Service. The medical director or his or her designee shall be available on-call 24 hours a day.

(b) A pediatrician with Continuing Care Nursery privileges shall be available on-call 24 hours a day.

(c) Nursing.
1. The hospital shall designate a registered nurse who has responsibility and accountability for the 24 hour nursing management of the Continuing Care Nursery service. At a minimum, such nurse shall be baccalaureate prepared (master's preferred) and have additional education in the 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. The hospital shall provide a baccalaureate prepared nurse educator with dedicated responsibility for coordinating and providing education activities to enhance staff knowledge or relevant procedures and technological advances for staff of the maternal and newborn service.

(d) A respiratory therapist with pediatric experience trained in neonatal transition and disease pathology (e.g. NRP) shall be present in-house to provide consultation on oxygen therapy and equipment maintenance.

(e) A medical engineer shall be responsible for the maintenance and safe functioning of specialized equipment per written hospital policy.

(2) Services. For designation as a Level IB Continuing Care Nursery Service, the hospital shall provide Level I care and services as well as the following Level IB care and services 24 hours a day, seven days a week:
(a) Continuous oxygen administration and short term oxygen therapy via nasal cannula and/or oxyhood.

(b) Umbilical artery and vein line insertion and maintenance, and maintenance of peripheral inserted central catheter (PICC).

(c) Long term antibiotic therapy via PICC.

(d) Gavage feedings.

(e) Management of mild apnea of prematurity.

(f) Positive infant stimulation, as appropriate, including but not limited to tactile, kinesthetic, auditory and visual measures such as rocking, touching, and vocalization to support positive and reciprocal interaction between infant and parents.

(g) Radiology, including portable x-ray 24 hours a day. Access to radiologist on staff, available dailyto interpret neonatal studies, such as chest and abdominal radiographs and cranial ultrasounds.

(h) Clinical laboratory services including microchemistry, in-house 24 hours a day.

(i) Respiratory therapy services, in-house, 24 hours a day.

(j) Access to an ophthalmologist with experience diagnosing conditions such as retinopathy of prematurity.

(k) Access to the services of a developmental specialist.

(3) Policies and Procedures. The Level IB Continuing Care Nursery shall have written policies and procedures for the following:
(a) Consultation with and/or transfer to a Level II or III service. All infants requiring mechanical ventilation shall be transferred to a Level III unit.

(b) The circumstances when the presence of a pediatrician designated to be responsible for newborn resuscitation and stabilization is required. A pediatrician with sole responsibility for resuscitation shall be present during the delivery of an infant anticipated to require stabilization and during the period awaiting actual transfer of the infant to a Level II or III service.

(c) Orientation and ongoing education for registered nurses including the theoretical framework and skills required to practice in the Level IB Continuing Care Nursery.

(d) If therapeutic formulas are made on-site, preparation and sealing of containers to prevent tampering.

(e) Management of infants with mild apnea of prematurity, neonatal abstinence syndrome or substance exposure, a PICC line, oxygen therapy and feeding related issues.

(f) Other policies and procedures as deemed appropriate by the hospital perinatal committee.

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