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 must collaborate with the maternal program , consulting physicians, and nursing leadership to ensure that pregnant patients who are at high risk of delivering a neonate that requires specialized care are transferred to a facility with specialized care capabilities before delivery unless the transfer would be unsafe. b. The facility shall ensure the provision of appropriate, supportive, and emergency care delivered by qualified personnel for unanticipated maternal-fetal or neonatal complications arising during labor and delivery, continuing through patient disposition. 2. On-Site Clinical Coverage a. Neonatologists The NICU neonatologists will: i. be a board eligible or certified neonatologist or equivalent; ii. Complete annual CME specific to neonatology; iii. Demonstrate a current status of NRP completion; 1. Have credentials that are reviewed by the NMD at least every two (2) years; and iv. Preferably be on-site and immediately available 24/7, a written policy will be in place that defines the criteria for notification and timeframe, as defined by the facility’s policies and procedures. 1. If a neonatologist is not on-site 24/7, a written policy will be in place that defines the criteria for notification and timeframe for on-site presence, and a tracking mechanism for compliance is required. 3. Privileged Care Providers Privileged Care Providers with neonatal-specific training qualified to manage the care of infants with mild to complex critical conditions, including emergencies, will be on site 24/7 and: i. Maintain current NRP certification or equivalent; ii. Complete annual continuing education in neonatal care; and review of credentials at least every two years by the NMD. iii. If no neonatologist on-site, have a board-certified neonatologist available for consultation and on-site, arrival within thirty (30) minutes of urgent requests. iv. Ensure back-up neonatologist coverage (documented on-call) if covering multiple facilities, with the same 30-minute response time. The facility will establish a written policy for backup privileged care provider coverage that establishes flexibility for variable census and acuity. This policy will document the criteria for notification and time frame for on- site presence, be based on allocating the appropriate number of competent medical providers to a care situation, attend to a safe and high-quality work environment, and be operationally reviewed annually for adequacy and adherence. 4. Pediatric Medical Subspecialists The facility must have on-site access to a broad range of pediatric medical subspecialties including, but not limited to; i. cardiology, pulmonology, infectious disease, neurology, ophthalmology, endocrinology, hematology, gastroenterology, nephrology, and genetics or metabolism; and ii. the pediatric medical subspecialists must: 1. be readily accessible for in-person consultation; 2. have credentials to consult at the facility, including documented training, certification, competencies, and continuing education specific to their subspeciality; and 3. document consultations in the medical record within an appropriate time frame and as defined by the facility’s policies and procedures. 5. Neonatal Surgical Program – Required for Level IV Pediatric Surgeons Pediatric surgeons and pediatric surgical specialists will: a. Be available at the bedside within one hour of request or identified need and be capable of performing major pediatric surgery, including surgery for complex conditions; b. If transplant or cardiac surgery is not offered on-site at the facility, policies and procedures will be in place to facilitate neonatal transport to a facility that provides appropriate surgical care; c. provide consultation to a broad range of pediatric surgical specialists including, but not limited to: d. general pediatric surgery, neurosurgery, urology, ophthalmology, otolaryngology, orthopedics, and plastic surgery; e. have credentials to provide care at the facility, including documented training, certification, competencies, and continuing education specific to their pediatric surgery specialty; f. establish a program for evaluating surgical performance by accurately tracking data, identifying trends, and implementing quality improvement initiatives to address surgical performance in a coordinated systematic approach within a culture of safety, equity, and prevention; and g. report neonatal surgical and anesthesia care back to the PI Committee. 6. Ancillary Services: a. Anesthesia 1. Pediatric anesthesiologists must be on the medical staff and promptly available 24/7 to respond to the bedside within 1 hour of request or identified need; 2. serve as the primary responsible anesthesia provider for all infants <24 mo. of age and should serve as the primary anesthesiologist for children ≤ 5 y of age or based on the ASA physical status classification; and 3. be physically present for all neonatal surgical procedures for which they serve as the primary responsible anesthesia provider. b. Laboratory and Transfusion Services 1. Laboratory services shall have: 1. laboratory personnel on-site 24/7; 2. the ability to determine blood type, crossmatch, and perform antibody testing; 3. a blood bank capable of providing blood component therapy and irradiated, leukoreduced or CMV-negative blood; a. policies and procedures will be in place to facilitate emergent access to blood and blood component therapy so that the NICU can provide a full range of hematologic interventions; 4. the ability to perform neonatal blood gas monitoring; 5. the ability to perform analysis on small volume samples; 6. the capability to process biopsies and perform autopsies; and 7. access to perinatal pathology services, if applicable. 2. Low-volume specialty laboratory services may be provided by an outside laboratory, but the facility will have policies and procedures in place to maintain timely and direct communication of all critical value results. c. Pharmacy – Pharmacy services must ensure at least one registered pharmacist experienced in neonatal/pediatric pharmacology is available at all times, completes continuing education requirements specific to pediatric and neonatal pharmacology and participates in multidisciplinary care, including participation in patient care rounds. i. If a pharmacy technician compounds medications for neonates/infants, a pharmacist must provide immediate, direct supervision of the process. The pharmacist must implement guidelines to address drug shortages, verify medications are appropriately allocated to the Level III NICU and verify the accuracy of each compounded product, monitor compounding activities through the pharmacy PI Plan, ii. Total parenteral nutrition (TPN) tailored for neonates/infants must be readily available upon request. 1. The facility will have a written policy and procedure for the proper preparation and delivery of TPN. c. Radiology – must adhere to the “As Low as Reasonably Achievable” (ALARA) principle for neonatal imaging and include the following: 1. Appropriately trained radiology personnel continuously available on- site to meet routine diagnostic imaging needs and to address emergencies. 2. Fluoroscopy available on-call 24/7; 3. Personnel appropriately trained in the following techniques will be on- call and/or available on-stie to perform advanced imaging as requested: a. ultrasonography, including cranial ultrasonography, b. computed tomography (CT), and c. magnetic resonance imaging (MRI) 4. the ability to provide timely imaging interpretation by radiologists with pediatric expertise as requested; 5. The facility will provide pediatric echocardiography and have the ability to consult with a pediatric cardiologist for timely echocardiography interpretation as requested. a. If fluoroscopy is not offered on-site at the facility, policies and procedures will be in place to facilitate transfer of an infant to a higher level of care. 6. Neonatal diagnostic imaging studies and radiologists with pediatric expertise to interpret the neonatal diagnostic imaging studies, available at all times; 7. A radiologist with pediatric expertise to interpret images consistent with the patient condition and within a time period consistent with current standards of professional practice with monitoring of variances through the Neonatal PI Plan and process; 8. Pediatric-trained radiologists must be available at all time for interpretation of neonatal and perinatal studies; any preliminary reads pending final interpretation must be documented in the medical record. 9. Pediatric echocardiography with pediatric cariology interpretation and consultation within professional timeframes. 10. The radiology PI Plan must compare preliminary and final readings, with summary reports submitted to Perinatal Multidisciplinary Committee. 11. Personnel trained in neonatal x-ray equipment must be on-site and available at all times. 12. Personnel appropriately trained in ultrasound, computed tomography, and cranial ultrasound equipment available on-site within a time period consistent with current standards of professional practice. 13. Fluoroscopy must be available at all times. 14. Neonatal diagnostic imaging studies and radiologists with pediatric expertise to interpret the neonatal diagnostic imaging studies, available at all times; 15. A radiologist with pediatric expertise to interpret images consistent with the patient condition and within a time period consistent with current standards of professional practice with monitoring of variances through the Neonatal PI Plan and process; 16. Pediatric-trained radiologists must be available at all times for interpretation of neonatal and perinatal studies; any preliminary reads pending final interpretation must be documented in the medical record. 17. Pediatric echocardiography with pediatric cariology interpretation and consultation within professional timeframes. 18. The radiology PI Plan must compare preliminary and final readings, with summary reports submitted to the Perinatal Multidisciplinary Committee. d. Respiratory Therapy The respiratory care leader will: i. be a full-time respiratory care practitioner, with neonatal and pediatric respiratory care certification preferred; ii. have sufficient time allocated to oversee the RTs who provide care in the level III NICU; iii. provide oversight of annual simulation and skills verification which includes neonatal respiratory care modalities and low-volume, high-risk neonatal respiratory procedures; iv. 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 v. maintain appropriate staffing ratios for infants receiving supplemental oxygen and positive pressure ventilation. Respiratory care practitioners assigned to the NICU will: i. be a respiratory care practitioner with documented experience and training in the respiratory support of newborns and infants, with neonatal and pediatric respiratory care certification preferred; ii. be on-site 24/7 and immediately available to supervise assisted ventilation, assist in resuscitation, and attend deliveries; iii. demonstrate a current status of NRP completion; iv. 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 NICU; and v. have their credentials reviewed by the respiratory care leader annually for adequacy and adherence. vi. provide neonatal/infant blood gas monitoring capabilities to support the management of respiratory and metabolic management. e. Therapy Services 1. The facility will provide on-site consultative services by qualified neonatal therapists to address the 6 core practice domains (environment, family or psychosocial support, sensory system, neurobehavioral system, neuromotor and musculoskeletal systems, and oral feeding and swallowing) and to provide the appropriate care for the neonatal population served. 2. The facility will have on-site access to the following neonatal therapists who have dedicated time allocated to serve the NICU: 1. an occupational and/or physical therapist with sufficient neonatal expertise, and neonatal therapy certification preferred; and 2. a speech language pathologist with neonatal expertise, skilled in the evaluation and management of neonatal feeding and swallowing concerns, and neonatal therapy certification preferred. 3. The facility will operationally review neonatal therapist personnel on an annual basis to maintain adequate multidisciplinary neonatal therapist coverage based on the specific need and volume of the neonatal population served. f. Dietician The NICU will have at least 1 full-time NICU-dedicated registered dietitian or nutritionist available on-site who has specialized training in neonatal nutrition and 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; 3. participate in multidisciplinary care, including participation in patient care rounds; and 4. have policies and procedures for dietary consultation for infants in the NICU. i. Neonatal Nutrition 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. ii. Lactation and Breastfeeding Support The facility will: 1. have personnel with the knowledge and skills to support lactation available at all times; 2. have an IBCLC available for on-site consultation on weekdays and accessible by telehealth or telephone 24/7; and 3. operationally review IBCLC personnel on an annual basis to establish adequately trained lactation coverage based on the specific need and volume of the neonatal population served. iii. Clinical Nurse Staffing A written nurse staffing plan is in place that establishes flexibility for variable census and acuity. This plan and actual staffing will be based on allocating the appropriate number of competent RNs to a care situation, attend to a safe and high-quality work environment, and be operationally reviewed annually for adequacy and adherence. iv. Clinical Nurse Staff Each clinical nurse will: 1. be an RN, with nursing certification specific to the care environment preferred; 2. demonstrate a current status of NRP completion; 3. participate in annual simulation and skills verification, which includes low-volume, high-risk procedures consistent with the types of care provided in the level III NICU; and 4. promote a family-centered approach to care, including but not limited to skin-to-skin care, appropriate developmental positioning based on gestational age, lactation and breastfeeding support, and engagement of families in their infant’s care. If the facility utilizes LPNs or non-licensed direct care providers to support the clinical nursing staff, the facility must: 1. have written criteria that define the LPNs’ or non-licensed direct care providers’ scope of neonatal care; 2. provide annual education specific to the care of the neonatal population served; and 3. have a written staffing plan that establishes collaborative work assignments in accordance with the facility’s policies and procedures. v. Clinical Nurse Specialist The clinical nurse specialist will : 1. be an RN, with neonatal nursing certification and clinical nurse specialist certification preferred; 2. have at least a Master of Science in Nursing, Doctorate preferred; 3. demonstrate a current status of NRP completion; 4. foster continuous quality improvement in nursing care; 5. develop and educate staff to provide evidence-based nursing care; 6. be responsible for mentoring new staff and developing team building skills; 7. provide leadership to multidisciplinary teams; 8. facilitate case management of high-risk neonatal patients; and 9. cultivate collaborative relationships with multidisciplinary team members and facility leadership to improve the quality of care and patient care outcomes. The facility will have a dedicated full-time equivalent (FTE) allocated to perform the roles and responsibilities of the NICU clinical nurse specialist. 7. 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. c. Staffing requirements for neonatal resuscitation shall include: 1. 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. 2. 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. 3.Additional personnel who maintain a current status of successful completion of the NRP or a Department-approved equivalent, must be on-site and immediately available upon request for the following: 4. Multiple birth deliveries; to care for each neonate; 5. Unanticipated maternal-fetal complications during labor and delivery; 6. Deliveries identified or suspected to be high-risk for the pregnant patient or the neonate. 4. Immediate on-site availability of all necessary resuscitative equipment, supplies, and medications. 5. Any deviations from these standards must be monitored through the Neonatal PI Plan, with reporting of variances to the Perinatal Multidisciplinary Committee 7. Neonatal Transport If the facility has a neonatal critical care transport program, it will have an identified director of neonatal transport services. The director of neonatal transport services can be the NMD or another physician who is a pediatrician, board-eligible or certified neonatologist, pediatric hospitalist, or pediatric medical subspecialist with expertise and experience in neonatal and infant transport. If the facility does not have its own transport program, the facility must have policies and procedures in place to identify a local neonatal transport program to facilitate transport. Responsibilities of the director of neonatal transport services include the following: i. Train and supervise staff; ii. Provide appropriate review of all transport records; iii. develop and implement policies and procedures for patient care during transport; iv. develop guidelines for determining transport team composition and medical control and establish a mechanism to track adherence; v. establish policies and procedures to provide transport updates and outreach education; vi. establish a program for evaluating performance by tracking data, identifying trends, and implementing quality improvement initiatives to address transport performance in a coordinated systematic approach within a culture of safety, equity, and prevention5; and vii. report neonatal transport data and neonatal-specific reviews back to the PI committee. viii. The director of neonatal transport services may delegate specific requirements to other person(s) or group(s) but retains the responsibility of certifying that these functions are addressed appropriately. The facility will: i. establish minimum education, experience, and training requirements for all transport team members; ii. select transport team members based on their experience and competence in the care of neonates and the transport team must collectively have the ability to provide a level of care that is similar to that of the admitting unit; and iii. provide annual transport education to all transport team members that incorporates equipment training, didactic education, simulation, and skills verification of low-volume, high-risk procedures consistent with the types of care provided during neonatal transport. 8. 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 at all times. Services shall include latch assessment, milk supply evaluation, and coordination with nutrition teams. An IBCLC should be available for on-site consultation on weekdays and accessible by telehealth or telephone at all times. IBCLC personnel should be operationally reviewed on an annual basis to establish adequately trained lactation coverage based on the specific need and volume of the neonatal population served. b. Child Life Services Child life services, or the equivalent, will be available for on-site consultation to support patient-and family-centered care by establishing and maintaining therapeutic relationships between patients, family members, multidisciplinary team members, and community resources. c. Social Worker The NICU social worker will: 1. be a Master’s prepared medical social worker with perinatal and/or pediatric experience. The facility will: 1. provide 1 social worker for every 30 beds providing level III neonatal care and/or specialty and subspecialty perinatal care; 2. have a written description that clearly identifies the responsibilities and functions of the NICU social worker; and 3. have social services available for each family with an infant in the NICU as needed. d. Pastoral Care Personnel skilled in pastoral care will be available as needed and by family request, and will represent, or have the ability to consult, multiple religious affiliations representative of the population served. e. Retinopathy of Prematurity The facility must have 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.