+ Certificate of Need (CON) Review Standards for NICU Beds & Special Newborn Nursery Services Effective March 3, 2014 Northern Michigan Perinatal Summit July 23, 2014 Tulika Bhattacharya, CON Michigan Department of Community Health
+ Neonatal Levels of Care 2012 Level I and Level II 2 Level I (Basic) Well Newborn Nursery Provide neonatal resuscitation at every delivery Evaluate and provide postnatal care to stable term newborn infants Stabilize and provide care for infants born at 35-37 weeks gestation who remain physiologically stable Stabilize newborn infants who are ill and those born before 35 weeks of gestation until transfer to a higher level of care Level II (Specialty) Special Care Nursery Level I capabilities plus: Care of infants > 32 weeks gestation or later and weigh 1,500 gm or more Infants with physiologic immaturity or moderately ill Problems that are expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis CPAP and mechanical ventilation for less than 24 hours Stabilization of born before 32 weeks gestation and weigh less than 1,500 gm until transfer to a NICU No surgery
+ Neonatal Levels of Care - 2012 NICU - Level III & Level IV 3 Level III (Subspecialty & NICU) Level II capabilities plus: Provide sustained life support Provide comprehensive care for infants born before 32 weeks of gestation and weigh <1,500 gm Provide care for infants of all gestational ages and birth weights with critical illness Provided full range of pediatric medical subspecialists, pediatric surgical specialists, pediatric anesthesiologists, pediatric ophthalmologists Provide full range of respiratory support (ventilation, high-frequency ventilation, inhaled nitric oxide Perform advanced imaging including computed tomography, magnetic resonance imaging and echocardiography Level IV (Regional NICU) Level III capabilities plus: Located within an institution with the capability to provide surgical repair of complex congenital or acquired conditions Maintain a full range of pediatric medical subspecialists, pediatric surgical subspecialists, and pediatric anesthesiologists at the site Facilitate transport and provide outreach education
Number of Birth Hospitals + Birth Hospitals in Michigan 4 84 Total (Plus Detroit Children s NICU) Birth Hospitals in Michigan by (Self Designated) Level of Care 50 40 30 20 10 0 49 14 Level I Level II Level III/IV 20
+ Issues 5 There has been NO regulation for Level II hospitals or Special Care Nurseries in the state Wide variation in level of care provided in Level II Regulation will provide a level of safety and quality for infants in Michigan Provide consistency and a level of standardization based on national standards Why regulate? Literature and evidence indicate that states with a regionalized and coordinated perinatal system of care better assure that pregnant women and babies are more likely to deliver in an appropriate hospital setting and receive appropriate services to meet their needs.
+ CON Standards for Neonatal 6 Intensive Care Services/Beds and Special Newborn Nursing Services Web link: http://www.michigan.gov/documents/mdch/copy_of_birthhosp-selfdesignation-scn-3_19_2013_418297_7.pdf (www.michigan.gov/con, see link Review Standards inside Resources box)
+ Special Care Nursery (SCN) "Special care nursery services" or SCN services means provisions of the services identified in subsections (i) through (v) for infants with problems that are expected to resolve rapidly and who would not be anticipated to need subspecialty services on an urgent basis. Referral to a higher level of care should occur for all infants who need pediatric surgical or medical subspecialty intervention. Infants receiving transitional care or being treated for developmental maturation may have formerly been treated in a neonatal intensive care unit (NICU) in the same hospital or another hospital. For purposes of these standards, SCN services are special newborn nursing services. (i) Care for low birth weight infants weighing 1,500 grams or more and/or greater than or equal to 32 weeks gestation; (ii) enteral tube feedings; (iii) cardio-respiratory monitoring to document maturity of respiratory control or treatment of apnea; (iv) extended care following an admission to a NICU for an infant not requiring ventilatory support; or (v) provide mechanical ventilation or continuous positive airway pressure or both for a brief duration (not to exceed 24 hours combined). SCN will be considered a service and SCN beds (bassinets) will not count against the number of licensed beds within a facility. 7
+ CON Application Process 8 SCN services are considered a Level II NICU service No hospital in Michigan currently holds a CON for SCN All hospitals will need to obtain a CON in order to provide SCN service after January 1, 2016 A hospital currently providing NICU service will not have to apply for SCN service File a Letter of Intent first (processed within 15 days) CON application to initiate SCN service must be filed by March 2, 2015 (review timeline 120-150 days) CON approval must be received by January 1, 2016 Once project is complete, applicant needs to file PIPR
+ Compliance & Monitoring 9 Proposed SCN services will not be required to discontinue current service while applications are being processed within the established timeline After January 1, 2016, all SCN services are subject to these CON Review Standards, effective March 3, 2014, for compliance and monitoring purposes The SCN service will provide statistical data through the CON Annual Survey tool
+ Compliance & Monitoring 10 The SCN service will need to provide the following on an annual basis: Verification of discharge planning process Percentage of transfers to a higher level of care Hours of life at the time of transfer to a higher level of care Admissions to the SCN at less than 32 weeks gestation Number of admissions requiring respiratory support greater than 24 hours in duration Number of admissions, discharges, and patient days of care for SCN Rates of morbidity including: o Intraventricular hemorrhage (grade 3 and 4) o Retinopathy of prematurity (stage 3 and 4) o Chronic lung disease (oxygen dependency at 36 weeks gestation) o Necrotizing enterocolitis o Pneumothorax.
+ CON Application Documentation 11 Online application forms, standard and required documents, selected by the Department Verifiable documentation for the following: A board certified neonatologist serving as the program director. Name, certificate(s), resume The hospital has the following capabilities and personnel continuously available and on-site: The ability to provide mechanical ventilation and/or continuous positive airway pressure for up to 24 hours; and portable x-ray equipment and blood gas analyzer Make, model, serial number (if owned); vendor quote (if proposed) Pediatric physicians and/or neonatal nurse practitioners; and Respiratory therapists, radiology technicians, laboratory technicians and specialized nurses with experience caring for premature infants Names, work schedule, credentials, resume
+ CON Application Documentation 12 Written consulting agreement with a NICU hospital The agreement must specify the details as outlined in Section 9(2) of the CON review standards Site and floor plans for the proposed SCN The SCN physical space must meet the Minimum Design Standards for Health Care Facilities in Michigan (HFES, MDLARA)
+ Questions?
+ CON Contact 14 Tulika Bhattacharya, Manager Phone: 517-241-3344 E-mail: bhattacharyat@michigan.gov Joette Laseur, Reviewer/Specialist: 517-241-3342 laseurl@michigan.gov Andrea Moore, Compliance Analyst: 517-241-3345 moorea20@michigan.gov Abby Mitchell, Project Coordinator: 517-241-3348 mitchella7@michigan.gov