Clinical Components

Clinical Components The clinical components outlined below form the foundation for delivering integrated, high-quality maternal and neonatal care. They ensure seamless collaboration, timely availability of skilled providers, access to essential support services, and standardized stabilization and resuscitation protocols. 1. Maternal – Neonatal Collaboration a. The neonatal program shall collaborate with the maternal program, consulting physicians, and nursing leadership to ensure that pregnant patients identified as high risk for requiring higher-level neonatal care are transferred to a higher-level facility prior to delivery, unless such transfer is deemed clinically unsafe. b. The facility shall ensure the provision of appropriate, supportive, and emergency care by qualified personnel for unanticipated maternal-fetal or neonatal complications arising during labor and delivery, continuing through patient disposition. 2. On-Call Coverage - The on-call physician, advanced practice nurse, or physician assistant shall: a. Possess documented special competence in neonatal care, with privileges and credentials formally reviewed and approved by the NMD. b. Maintain current certification in the NRP or department-approved equivalent. c. Complete annual continuing education specific to neonatal and infant care. d. Respond to an urgent request by arriving at the patient’s bedside within thirty (30) minutes of notification. e. Ensure documented back-up coverage where the on-call provider is unavailable or covering multiple facilities, with back-up call providers likewise responding within thirty (30) minutes of an urgent request. f. Where neonatal surgery is performed, a surgeon privileged and credentialed to operate on neonates/infants shall be on-call and shall arrive at the patient’s bedside in a timeframe consistent with current standards of professional practice. Surgeon response times shall be monitored and reviewed through the Neonatal PI Plan. 3. Ancillary Services: a. Anesthesia i. Anesthesia services shall be provided by practitioners with demonstrated pediatric experience and competence. b. Laboratory and Transfusion Services i. Laboratory services shall ensure personnel are on-site at all times, as defined by written management guidelines, including when a neonate/infant is maintained on endotracheal ventilation. The ability to determine blood type, crossmatch, and perform antibody testing and the ability to perform analysis on small volume samples. ii. Low-volume specialty laboratory services may be provided by an outside laboratory, but the facility will have policies and procedures in place to verify timely and direct communication of all critical value results. iii. The facility’s blood blank shall be capable of providing blood and blood component therapy and irradiated, leukoreduced or cytomegalovirus negative blood within the timelines established and approved transfusion guidelines. c. Pharmacy – Pharmacy services must ensure a registered pharmacist experienced in neonatal/pediatric pharmacology is available at all times and completes continuing education requirements specific to pediatric and neonatal pharmacology. i. If a pharmacy technician compounds medications for neonates/infants, a pharmacist must provide immediate, direct supervision of the process. ii. The pharmacy will have policies and procedures in place to address drug shortages and to verify medications are appropriately allocated to the level II SCN; and must implement policies and procedures to verify the accuracy of each compounded product, monitor compounding activities through the pharmacy PI Plan, and present summary reports at Perinatal Multidisciplinary Committee meetings. d. Radiology – must adhere to the “As Low as Reasonably Achievable” (ALARA) principle for neonatal imaging and provide the following: i. Personnel trained in neonatal x-ray and ultrasound operation, including cranial ultrasonography, must be on-site and able to respond to urgent requests within 30 minutes. Appropriately trained staff must remain continuously available to meet routine diagnostic imaging needs and to manage emergencies . ii. Interpretation of neonatal and perinatal studies must be available at all times; any preliminary reads pending final interpretation must be documented in the medical record. iii. The radiology PI Plan must compare preliminary and final readings, with summary reports submitted to the Perinatal Multidisciplinary Committee. e. Respiratory Therapy i. The respiratory care leader will: 1. be a full-time respiratory care practitioner, with neonatal and pediatric respiratory care certification preferred; 2. have sufficient time allocated to oversee the respiratory therapists (RTs) who provide care in the level II facility; 3. provide oversight of annual simulation and skills verification, which includes neonatal respiratory care modalities and low- volume, high-risk neonatal respiratory procedures; 4. develop a written RT staffing plan that establishes flexibility for variable census and acuity. This plan and actual staffing will be based on allocating the appropriate number of competent RTs to a care situation, attend to a safe and high-quality work environment, and be operationally reviewed annually for adherence and to verify respiratory therapy staffing is adequate for patient care needs; and 5. maintain appropriate staffing ratios for infants receiving supplemental oxygen and positive pressure ventilation. ii. Respiratory care practitioners assigned to the special care nursery will 1. be a respiratory care practitioner with documented experience and training in the respiratory support of newborns and infants, with neonatal or pediatric respiratory care certification preferred; 2. be on-site 24/7 and immediately available when an infant is supported by assisted ventilation or CPAP; 3. be able to attend deliveries and assist with resuscitation as requested; 4. demonstrate a current status of NRP completion; 5. participate in annual simulation and respiratory skills verification, which includes low-volume, high-risk procedures consistent with the types of respiratory care provided in the SCN; and 6. have their credentials reviewed by the respiratory care leader annually for adequacy and adherence. iii. The facility shall maintain neonatal/infant blood gas monitoring capabilities to support the management of respiratory function and acid–base status in acutely ill neonates. f. Therapy services – A speech, occupational, or physical therapist with neonatal expertise must be engaged to meet the developmental and functional needs of the patient population. i. Therapy services should be individualized based on gestational age, clinical status, and family goals. ii. At least one individual skilled in the evaluation and management of neonatal feeding and swallowing concerns, with neonatal therapy certification preferred. iii. Therapists must document competencies in neonatal care and participate in the Neonatal PI Plan for therapeutic interventions. g. Nutrition i. Nutrition services shall be provided by a registered dietitian or a nutritionist trained in neonatal nutrition who will 1. collaborate with the medical team to establish feeding protocols, develop patient-specific feeding plans, and help determine nutritional needs at discharge; 2. establish policies and procedures to verify proper preparation and storage of human milk and formula; and 3. have policies and procedures for dietary consultation for patients. ii. The facility will: 1. provide a specialized area or room, with limited access and away from the bedside, to accommodate mixing of formula or additives to human milk; 2. develop standardized feeding protocols for the advancement of feedings based on the availability of, and family preference for human milk, donor human milk, fortification of human milk and formula; and 3. have policies and procedures in place for accurate verification and administration of human milk and formula, and to avoid misappropriation. 4. Stabilization and Resuscitation a. The facility shall develop, maintain, and enforce written policies, procedures, and guidelines for the stabilization and resuscitation of neonates, in accordance with current standards of professional practice. b. The facility shall ensure the availability of trained personnel capable of stabilizing distressed neonates, including those of less than thirty-five (35) weeks gestation, until safe to transfer to a higher-level of care. c. Staffing requirements for neonatal resuscitation shall include: i. Attendance by at least one individual, at the time of each birth, who holds current NRP certification (or Department-approved equivalent) and whose primary responsibility is neonatal management and resuscitation. ii. At least one additional provider with full neonatal resuscitation skills - including endotracheal intubation, vascular access establishment, and administration of emergency medication – must be immediately available on-site. iii. Immediate availability of additional NRP-certified personnel for: 1. Multiple birth deliveries; 2. Unanticipated maternal-fetal complications during labor and delivery; 3. Deliveries identified or suspected to be high-risk. iv. Immediate on-site availability of all necessary resuscitative equipment, supplies, and medications. v. Any deviations from these standards must be monitored through the Neonatal PI Plan, with reporting of variances to the Perinatal Multidisciplinary Committee. 5. Neonatal Transport The facility will have policies and procedures in place to identify a local neonatal transport program to facilitate transport to a higher-level neonatal facility. 6. Pediatric Medical Subspecialists and Pediatric Surgical Specialists Policies and procedures will be in place for referral to a higher level of neonatal care when pediatric medical subspecialty or pediatric surgical specialty consultation and/or intervention is needed. 7. Support Services a. The neonatal program shall ensure the availability of personnel with specialized knowledge and skills in breastfeeding and lactation, to provide assistance and counseling to mothers. Services shall include latch assessment, milk supply evaluation, and coordination with nutrition teams. Breastfeeding support activities are reviewed periodically through the Neonatal PI Plan. b. The facility shall provide social services, spiritual care, and counseling resources, as appropriate, to address the holistic needs of the patient population served. Referrals to community resources and follow-up support are coordinated through the neonatal team. i. The Level II social worker will be a Master’s prepared medical social worker with perinatal and/or pediatric experience. ii. The facility will: 1. Provide 1 social worker for every 30 beds providing Level II neonatal care and/or specialty and subspecialty perinatal care 2. Have a written description that clearly identifies the responsibilities and function of the social worker and 3. Have social services available for each family member with an infant in the special care nursery as needed. 8. Retinopathy of Prematurity If the facility back transfers infants for convalescent care, the facility must have a process in place to appropriately identify infants at risk for retinopathy of prematurity to guarantee timely examination and treatment by having documented policies and procedures for the monitoring, treatment, and follow-up of retinopathy of prematurity and the ability to perform on-site retinal examinations, or off-site interpretation of digital photographic retinal images, by a pediatric ophthalmologist or retinal specialist with expertise in retinopathy of prematurity, if needed. 9. Discharge Planning and Follow-Through Care a. The Neonatal Program must develop and implement discharge plans for infants at high risk of neurodevelopmental, medical, or psychosocial complications. i. Plans include referrals to specialty care, early intervention programs, and community-based services. 1. The facility will have written medical, neurodevelopmental, and psychosocial criteria that automatically warrant high-risk neonatal follow-up with appropriate developmental follow-up services; and have a written referral agreement with a developmental follow-up clinic or practice, when possible, to provide neurodevelopmental services for the neonatal population served. ii. Follow-up outcomes are monitored via the Neonatal PI Plan to ensure continuity of care. 10. Nurse Education and Orientation Level II Neonatal Centers nursing orientation will incorporate didactic education, simulation, skills verification, and competency and shall be tailored to the individual needs of the nurse based on clinical experience. The facility must document an annual educational needs assessment to determine the educational needs of the clinical nursing staff and ancillary team members. Annual nursing education will address the annual needs assessment and incorporate simulation and skills verification of low-volume, high-risk procedures consistent with the types of care provided in the level II centers and include education related to serious safety events. 11. Clinical Nurse Educator a. be an RN, with nursing certification specific to the care environment preferred; b. have at least a Bachelor of Science in Nursing, Master’s preferred; c. demonstrate a current status of NRP completion; d. cultivate collaborative relationships with the neonatal nurse leader and facility leadership to improve the quality of care and patient care outcomes5; and e. have experience and expertise to evaluate the educational needs of the clinical staff, develop didactic and skill-based educational tools, oversee education and skills verification, and evaluate retention of content, critical thinking skills, and competency relevant to level II neonatal care.9 f. The facility will have a dedicated individual with sufficient time allocated to perform the roles and responsibilities of the clinical nurse educator. The