Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 130.000 - Hospital Licensure
Subpart D - SUPPLEMENTARY STANDARDS: PARTICULAR SERVICES
Section 130.616 - Administration and Staffing

Universal Citation: 105 CMR 130.000 MA Code of Regs 130.616

Current through Register 1531, September 27, 2024

(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 regularly transfer 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, previouslydischarged 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 immediately available 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 casemix 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.

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