ࡱ>        @ D~bjbj f\\\\\\\4"""h`#$' BS12F22v3Q4N44QRSRSRSRSRSRSRURDXjSRQ\Q4Q4SR\\2v3RJjjj \2\v3QRjQRjj^\\&2|1 @"(rhm4RTBSXlX&\\\\&X\) 4S*ji{O444SRSRd d Perinatal Regionalization: Implications for Michigan A report by the Michigan Department of Community Health (MDCH) in collaboration with Michigan neonatal, obstetric and pediatric stakeholders. April 2009 PERINATAL REGIONALIZATION NEONATAL WORKGROUP Co-Chairs Paul Holtrop, MD President Society of Michigan Neonatologists Padmani Karna, MD Neonatologist, QI MSU/Edward W. Sparrow Hospital Members Rose Mary Asman Manager, Perinatal Health Unit Division of Family & Community Health MI Department of Community HealthJoette Laseur Specialist Review Certificate of Need MI Department of Community HealthGeorge Baker, MD Chief Medical Consultant Office of Medical Affairs MI Department of Community Health Charlotte Mather, RN, BSN, MBA Robert Wood Johnson Exec. Nurse Fellow Administrative Director Women's and Childrens Services Genesys Regional Medical CenterGregory Berger, MD Quality Management, Women and Children Services Health Plan of MichiganJoshua Meyerson, MD, MPH Medical Director NW MI Community Health Agency Alethia Carr Director, Bureau of Family, Maternal & Child Health MI Department of Community HealthAndrea Moore CON Policy Section MI Department of Community HealthSandy Geller, RN, MSN, CNNP Neonatal Nurse Edward W. Sparrow Hospital Carol Ogan Department Specialist Bureau of Family, Maternal & Child Health MI Department of Community HealthViolanda Grigorescu, MD Director, Division of Genomics, Perinatal Health & Chronic Disease Epidemiology Bureau of Epidemiology MI Department of Community Health Dilip R. Patel, MD, FAAP Neurodevelopmental Pediatrician MSU Kalamazoo Center for Medical Studies Medical Consultant, Children's Special Health Care Services MI Department of Community HealthKara Hamilton, Director Program Services March of DimesMichael Weiss, DO Osteopathic Medicine Lynette Johnson, RNC, BSN, MSA Neonatal Outreach Coordinator Helen DeVos Childrens HospitalJoslyn N. Witherspoon, MD, MPH Preventive Medicine Resident University of Michigan PERINATAL REGIONALIZATION PEDIATRIC WORKGROUP Co-Chairs Wendy Burdo-Hartman, MD NICU Follow-up Clinic Director, Gerber Center of Infant Development and Nutrition, DeVos Childrens Hospital Sue Marr, BSN, MPH Director, Corporate Compliance/Quality Improvement Mott Childrens Health CenterMembersAyesha Ahmad, MD Assistant Professor, Pediatrics Genetics Co-Director, Biochemical Genetic Lab, University of MichiganNina Mattarella, MD Pediatric Hospitalist Childrens Special Health Care Services MI Department of Community HealthRose Mary Asman Manager, Perinatal Health Unit Division of Family & Community Health MI Department of Community HealthCarol Ogan Department Specialist Bureau of Family, Maternal & Child Health MI Department of Community HealthGeorge Baker, MD Chief Medical Consultant Office of Medical Affairs MI Department of Community HealthNancy Peeler Manager, Child Health Unit Division of Family & Community Health MI Department of Community HealthAlethia Carr, Director Bureau of Family, Maternal & Child Health MI Department of Community HealthJenny Salesa Consultant Early Childhood Investment CorpViolanda Grigorescu, MD Director, Division of Genomics, Perinatal Health & Chronic Disease Epidemiology Bureau of Epidemiology, MDCHKathy Stiffler Director, Childrens Special Health Care Services MI Department of Community Health Douglas N. Homnick, MD, MPH Director, Division of Pediatric Pulmonary Medicine Michigan State University Kalamazoo Center for Medical StudiesShannon Stotenbur-Wing, MSW Program Director of Child & Adolescent Health Michigan Public Health Institute Rick Johansen, MD, MPH Medical Director, Berrien County Health Department and Van Buren-Cass District Health Department Pediatrician Southwestern Medical ClinicDebra Szwejda, Manager HIV/AIDS Prevention & Intervention Section Division of Health Wellness & Disease Control MI Department of Community HealthAmy Krug Vice President for Programs Priority ChildrenJudith Tubbs, RN, BSN, MSA Ambulatory Benefits Section, Program Policy Div. MI Department of Community HealthJoette Laseur Specialist Review, Certificate of Need MI Department of Community HealthIvana M. Vettraino, MD, MBA Director, Maternal Fetal Medicine Hurley Medical CenterJulie Lumeng, MD Dev. Behavior Pediatrician University of Michigan PERINATAL REGIONALIZATION OBSTETRIC WORKGROUP Co-Chairs Marjorie C. Treadwell, MD Director, Perinatal Assessment Center Maternal-Fetal Medicine, Professor, OB/GYN University of Michigan Medical School Richard Smith, MD, FACOG President Elect, Michigan State Medical Society Henry Ford Health SystemsMembersLinda Thompson Adams, DrPH, RN, FAAN Dean and Professor, School of Nursing Oakland UniversityTheodore Jones, MD Chair, Maternal Fetal Medicine WSU/DMC/Hutzel HospitalRose Mary Asman Manager, Perinatal Health Unit Division of Family & Community Health MI Department of Community HealthJoette Laseur Specialist Review, Certificate of Need MI Department of Community HealthGeorge Baker, MD Chief Medical Consultant Office of Medical Affairs MI Department of Community Health Richard E. Leach, MD Professor and Chair Dept. of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine Michigan State UniversityAlethia Carr, Director Bureau of Family, Maternal & Child Health MI Department of Community HealthFederico G. Mariona MD FACOG Maternal Fetal Medicine Oakwood Hospital & Medical CenterKatherine Coffield, CHE Administrator, Business Development \Women & Childrens Services Hurley Medical CenterKaitlin McNally, RN Prenatal Case Manager Healthy First Steps Program Administrator Great Lakes Health PlanCatherine Collins-Fulea, MSN, CNM, FACNM Division Head, Midwifery Henry Ford Health SystemDebra Nault, RN, MSN, CNM Clinical Nurse Specialist, Perinatal Services Edward W. Sparrow HospitalWendy Finsterwald-Watts, RNC, MA Regional Coordinator Bronson Methodist Hospital Carol Ogan Department Specialist Bureau of Family, Maternal & Child Health MI Department of Community HealthMarcia Franks, BS Public Health Supervisor Maternal-Infant Health & Mortality Programs Genesee County Health DepartmentMary Helen Quigg, FACOG, FACMG Reproductive Geneticist Department of Medical Genetics Henry Ford Health SystemsViolanda Grigorescu, MD Director, Division of Genomics, Perinatal Health & Chronic Disease Epidemiology Bureau of Epidemiology, MDCHKimberly Sepulvado, RN Project Development Coordinator MI Health and Hospital Association Sandra Hart, RNC, MSA Nursing Director, Womens & Children Bronson Methodist HospitalHania Zdanukiewicz, RN Labor & Delivery Nurse St. John Macomb HospitalArthur James, MD Staff Obstetrician, Borgess Medical Center Clinician, Kalamazoo County Family Health Center Associate Clinical Professor, OB/GYN and Reproductive Medicine, MI State UniversityLaura J. Zuidema, MD Director Maternal Fetal Medicine Spectrum Health Tim Johnson, MD Chair, OB Medicine Perinatalogist University of MichiganTheodore Jones, MD Chair, Maternal Fetal Medicine WSU/DMC/Hutzel Hospital  Contents PageExecutive Summary 7Introduction.. 9Background....... 10Fiscal Implications......................... .14Guidelines for Perinatal Levels of Care. 15Recommendations.. . 22Conclusions. 23Attachment A: Michigan Perinatal Level of Care Guidelines 24Attachment B: Definitions Attachment C: References. 49 51 EXECUTIVE SUMMARY Infant mortality is a major public health issue in the State of Michigan. For every 1,000 Michigan live births, approximately eight infants die before reaching their first birthday. Comparative data from the Centers for Disease Control and the Michigan Department of Community Health (MDCH, 2009) indicate Michigans infant mortality rate consistently exceeds the national average. Although Michigans population-based infant mortality rate has slightly decreased since 2000, alarming disparities continue to exist among various racial and ethnic groups, particularly between African Americans and Caucasians. To examine this issue, Michigan PA 246 of 2008 was signed into law, mandating the Michigan Department of Community Health to convene appropriate stakeholders to determine the efficacy and impact of restoring a statewide coordinated regional perinatal system in Michigan and report on practices, expected potential impact on infant mortality, and recommendations for policy and funding of such a system in Michigan. In response, MDCH convened work groups of clinical experts in neonatal, obstetrical, and pediatric specialties in early 2009 to produce this report. Michigan was a national leader in regionalization of perinatal systems in the 1970s and 1980s. This system gradually de-regionalized over the subsequent two decades, and by 2005, formal perinatal regionalization no longer existed in the state. Studies conducted in and outside Michigan found that highly specialized NICU staff and sophisticated equipment are necessary to care for neonates requiring complex, intensive treatment. A 2005 study produced by MDCH and Grand Valley State University recommended rebuilding perinatal regionalization, developing detailed definitions and evidence-based practice guidelines for levels of care, and examining capacity and need to develop more well-defined and coordinated regions. To date, evaluations of the impact of perinatal regionalization have focused primarily on the quality and safety of maternal and perinatal care, rather than fiscal analyses or return on investment. However, published information does support that regionalized perinatal care is inherently cost effective, because care is organized and delivered according to the evidence base and patient need. This report provides an initial administrative cost estimate to implement perinatal regionalization in Michigan, understanding that further studies and analyses are necessary. The Perinatal Workgroups also stressed the need for ongoing participation in quality improvement initiatives such as the Vermont Oxford Network, which collects data from neonatal intensive care units (NICUs) around the world to study the impact of interventions on outcomes of perinatal care. In order to implement perinatal regionalization, evidence-based guidelines for care are required that fully integrate applicable aspects of obstetric and neonatal clinical care. The Perinatal Workgroups were charged with modifying current, evidence-based obstetric and pediatric levels of care guidelines; as a result, Appendix A Michigan Perinatal Level of Care Guidelines was produced by consensus, which reflects Michigan-specific standards and will serve as the foundation for the States coordinated perinatal system. These Michigan guidelines include strategies to improve access to service, identify risk early, provide linkage to the appropriate level of care and ensure compliance, continuity and comprehensiveness. Recommendations As discussed in this report, the Michigan Perinatal Care workgroups recommended that Michigan: Adopt the Michigan Perinatal Level of Care Guidelines. Develop a method of authoritative recognition of levels of NICU care and establish a statewide mechanism to oversee and enforce adherence to the Michigan guidelines to ensure that hospitals and NICUs care for only those mothers and neonates for which they are qualified The Guidelines should be periodically reviewed and updated as new data occur and recommendations from national groups are made. If the authoritative recognition of levels of care is through the Certificate of Need process, Create a provision to retrospectively change a hospitals perinatal level of care designation All Level III NICUs should have a NICU Follow-up Clinic Standards for the NICU Follow-up Clinics should be developed and the State should develop a mechanism for authoritative recognition of the NICU Follow-up Clinic Ensure that NICU Follow-up Clinics have the capacity for complete evaluation, both medical and developmental NICU follow-up care should be covered by insurance, including neurodevelopmental testing, to assure continued access to care and to reduce barriers to services. The state should allocate funds so that all Level III babies receive home visits. Educate medical providers about the needs of NICU graduates Support the enrollment of all NICUs in Vermont Oxford Network Develop a mechanism for follow-up of privately insured infants Utilize available data (e.g., Public Health Surveillance system, Medicaid data warehouse, etc.) and track outcomes on key indicators, such as long-term effect of NICU care/treatment and infant mortality Develop a system to follow-up on NICU graduates, including: Create a mechanism to capture all child/family services in one record, with information from all providers coordinated and shared. Connect to MDCH Health Information Technology Project to track outcomes, especially the long-term effects of NICU care/treatments and infant mortality. An electronic record is ideal, or use of a database such as the Michigan Care Improvement Registry (MCIR). The State of Michigan should address the critical shortage of nurses in the state and conduct ongoing evaluations of staffing shortages and potential impact on the provision of care Convene an annual conference or meeting with representatives from all Levels of Care to review and provide education regarding the guidelines and areas for improvement in the care to obstetric patients, neonatal and pediatric care. Convene representatives from all entities involved in the delivery of optimal healthcare to women and children at regional and state levels to discuss barriers to optimal care and mechanisms to resolve those barriers Work in collaboration with EMS/trauma system to thus assure that each perinatal patient get to the right place in the right time. There is currently an internal collaborative effort at MDCH that will lead to a better understanding of the common venues for further coordination. Conclusions Creating a system for regionalized perinatal care is an approach consistent with evidence-based guidelines promulgated by the American Academy of Pediatrics and the American College of Obstetrics and Gynecology and successfully adopted by other states. This approach ensures that hospitals and NICUs operate within appropriate, clearly defined level of care designations and ensures collaboration among regional entities providing services to women, neonates/infants and families. Convening subject matter experts in OB, Neonatology, and Pediatrics was a unique opportunity to examine pediatric regionalization in Michigan. This collaborative approach also established a venue to develop comprehensive Michigan perinatal guidelines and obtain valuable recommendations for policy improvements in the area of perinatal care. Introduction Infant mortality is a major public health issue in the State of Michigan. For every 1,000 Michigan live births, approximately eight infants die before reaching their first birthday. Available comparative data from the Centers for Disease Control and the Michigan Department of Community Health (MDCH, 2009) indicate Michigans infant mortality rate consistently exceeds the national average. Although Michigans population-based infant mortality rate has slightly decreased since 2000, alarming disparities continue to exist among various racial and ethnic groups, particularly between African Americans and Caucasians. In 2007, Michigans African American infant mortality rate (16.5) was 2.8 times higher than that of white infants (5.8) and 1.5 times higher than the rate for other races (10.7). Low birth weight and preterm birth are predictors of infant mortality. Very low birth weight infants (VLBW, weighing less than 1,500 grams) and very preterm (born before 32 weeks gestation) are at high risk of death in the first year of life. In 2006, Michigans VLBW rate was 1.2 per 100 live births for Caucasian babies and 3.5 for African American babies. The rate of births less than 32 weeks gestation was 1.6 per 100 live births for Caucasian babies and 3.7 for African American babies. Perinatal Periods of Risk (PPOR) is another approach used to better understand the causes of infant mortality and to develop targeted strategies. Among PPOR groups (maternal health/prematurity, maternal care, neonatal care, and infant health), data suggest Maternal Health/Prematurity (fetal, neonatal, and post-neonatal of 500 1,499 grams) is a focal group for targeted intervention. Literature review and national experts 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. Michigan has not had a regionalized perinatal system since the early 1990s; since that time, health system changes have resulted in a non-regionalized approach to referrals and transfers, leading to decreases in the number of high-risk pregnancies delivered at hospitals with neonatal intensive care units (NICUs). To examine this issue, Michigan PA 246 of 2008 was signed into law, mandating the Michigan Department of Community Health to convene appropriate stakeholders to determine the efficacy and impact of restoring a statewide coordinated regional perinatal system in Michigan. A report shall be produced that reflects best practices, expected potential impact on infant mortality, and recommendations for policy and funding of such a system in Michigan. The report shall be provided to the house and senate appropriations subcommittees on community health and standing committees on health policy, the house and senate fiscal agencies, and the state budget director by April 1, 2009 (Section 1116). In response, MDCH convened a group of subject matter experts and stakeholders comprised of obstetric, neonatal, and pediatric physicians and nurses; representatives the Early Childhood Investment Corporation (ECIC); managed care plans; the Michigan Public Health Institute; and others to meet and address these requirements and produce the report outlined in the Public Act. Background Historic Perspective of Perinatal Regionalization Although regionalization of perinatal care can be traced to the development of premature infant centers in the United States during the 1930s and 1940s, the 1976 March of Dimes Foundation Committee on Perinatal Health report, Toward Improving the Outcome of Pregnancy: Recommendations for the Regional Development of Maternal and Perinatal Health Services (TIOP I) is recognized as the sentinel document stimulating acceptance and rapid diffusion of regionalization across the country. From the mid-1970s and mid-1980s, improved perinatal risk identification, transport, and technology and the application of levels of care became accepted as national standards of care (American Academy of Pediatrics, American College of Obstetricians and Gynecologists, 2002). Butterfield (1980) also emphasized potential system improvements that were possible effects of regionalization (i.e., expanded role of nursing, inter-hospital care, shared services, and systems development). Subsequently, the number of neonatologists increased, as did the number of NICUs, often in low-volume units in small community hospitals. These phenomena led to increasing deregionalization of perinatal services. As a result, the March of Dimes Foundation Committee on Perinatal Health was reinstituted and published Toward Improving the Outcome of Pregnancy: the Nineties and Beyond (TIOP II) (1993). TIOP II included recommendations for expanding the TIOP I emphasis on hospital care around the time of birth to a more comprehensive spectrum of prenatal and preconception care, expanded use of data systems for quality improvement and increased accountability, and stronger roles for local/regional centers. The emphasis on perinatal health was further emphasized by Grayson and Guyer (1995), which indicated one of the top ten essential services to be performed by maternal child health agencies, is to evaluate the effectiveness, accessibility, and quality of perinatal health and population-based maternal and child health services. In 2004, The American Academy of Pediatrics (AAP) published a policy statement, Level of Neonatal Care recommending regionalized systems of perinatal care. The concept of regionalized perinatal care has been shown to improve outcomes among high-risk infants. According to information published by the Robert Wood Johnson Foundation (2001), Nigel Paneth of Michigan State University found that mortality of low birth weight babies was significantly higher in Level I and Level II centers than in Level III centers; in some areas, mortality decreased by one third to one half when babies were cared for in tertiary centers. Despite this, regional perinatal networks began to dissolve; this dissolution was attributed to both competition between Level III and Level II hospitals and the effect of managed cares geographically constructed networks. However, that was not the finding of Dobrez (2006) who conducted an extensive retrospective study examining the perinatal regionalization experience in four states (California, Illinois, North Carolina and Washington). He concluded that managed care had no negative impact on the regionalization model or birth outcomes in those states. Healthy People 2010 (U.S. Department of Health and Human Services) established goals of 90% for both very low birth weight infants being delivered in subspecialty hospitals and women obtaining early and adequate prenatal care. A retrospective cohort study conducted by Attar, Hanrahan, Lang, Gates, and Bratton (2006) found that mothers of VLBW infants who did not receive adequate prenatal care and did not live in the vicinity of a subspecialty center were at increased risk for delivery outside a center and appropriate place of birth for low-income may be influenced by proximity to a regional center. These findings strongly support a regional approach to perinatal care delivery. Perinatal Regionalization: Experiences in Other States A number of other states have well-established regional mechanisms for the delivery of perinatal care. This section briefly examines regionalization programs in other states and potential application to Michigan. It should be noted that although the structure, provision and funding of coordinated care for perinatal services at the local or regional levels differ among states, the goal is to ensure that pregnant women and newborns have access to appropriate levels of high quality, safe and effective care, in time, before, during and after delivery. In addition, state goals include meeting the needs of the infants at risk for neonatal complications and reducing the incidence of maternal death due to obstetric complications. Table 1 Perinatal Regionalization Structure by State The following states were included in a 2006 report prepared for the Virginia Department of Health, Office of Family Health Services. Each of these states reported they were generally satisfied with their current system for perinatal regionalization. Specifically, these states reported that regional entities helped in understanding regional/local needs, assisted in providing high-risk populations with needed services, and assisted with the successful implementation of new perinatal health initiatives through relationships with local entities. The challenges or concerns cited centered on methods to ensure equitable resource distribution, and maintaining effective communication without adding administrative burden. StateRegional StructureMarylandState structure includes local public health departments in 24 counties that work with communities. The program is funded by grant dollars from the State DOH to conduct fetal infant mortality review. All Medicaid recipients are enrolled in managed care which provides case management. New York The state has 15 perinatal networks and 11 regional forums (perinatal centers). The networks are separate non-profit organizations; all housed in community organizations. This system of regionalized perinatal services includes four levels of perinatal care provided by hospitals within a region (called affiliate hospitals). Each region has a Regional Perinatal Center (RPC), which provides the most sophisticated care and provides education, advice and support to their affiliate hospitals. The state has designated 145 hospitals as Perinatal Centers. State and federal funding support the perinatal networks (based on the number of births and hospitals).  HYPERLINK "http://www.health.state.ny.us/community/pregnancy/health_care/perinatal/regionalization_descrip.htm" http://www.health.state.ny.us/community/pregnancy/health_care/perinatal/regionalization_descrip.htmNorth CarolinaNorth Carolinas DOH contracts with four tertiary centers and 13 local health departments to coordinate care for high-risk populations. Case management services are provided by Medicaid on a statewide basis. The state also provides funding to sites with high levels of non-Medicaid populations. New JerseyThe states system includes six independent, non-profit regional perinatal maternal and child health consortia. Consortia include a mix of community-based providers, hospitals and consumers. The perinatal program is funded through a hospital assessment tax based on the number of births in each facility; the tax rate is established by the Consortia Board.  StateRegional StructurePennsylvania Local public health departments in the state oversee perinatal care; however, only 7 of 67 counties have health departments and oversee health in their district (3 city health departments, with the remainder of the state covered by six health districts). Each district has a maternal-child health consultant. Nurse family partnerships are utilized to provide structured home visits from pregnancy through 24 months. The program is funded by a mix of federal, state and local funding. South Carolina The South Carolina DOH contracts with five perinatal centers in four regions. The program includes a systems developer for perinatal services in each region. In addition, each center has an OB outreach and neonatal outreach educator. The regional systems developers work with all perinatal providers and hospitals in their regions to develop and support a system of risk-appropriate care for all mothers and babies. Funding for the program is through DOH and hospitals with state support formula that includes a base plus number of births. West VirginiaWest Virginias perinatal system includes eight regions, each with an administrative unit called a regional lead agency. These units are the perinatal infrastructure for statewide coordination of care. The regional agencies are contracted providers (e.g., local health departments) staffed with one nurse and administrative support. The program is funded through Medicaid match and state block grant dollars. Case management of high-risk infants is also funded by Medicaid and includes up to one year of services. The following states were not included in the Virginia report; information was obtained from other publicly available sources:StateRegional StructureGeorgia The Georgia Regional Perinatal Care Network (GRPCN) Project is a state/Medicaid funded program charged with the annual distribution of funds to eight designated regional centers for the care of eligible high risk mothers and infants. Funds are for the payment of direct costs associated with the care of high risk mothers and infants at the regional centers, as well as administrative costs associated with outreach, education and transport services provided to hospitals within each centers region. Payments for direct costs of care are designed to fill the gap between the Medicaid reimbursement and the cost of high risk services, as well as support the care of uninsured or insured patients with incomes less than or equal to 250% of the federal poverty level.  HYPERLINK "http://www.npic.org/Contracts/MedicaidFunding.php" http://www.npic.org/Contracts/MedicaidFunding.phpOhio The State of Ohios program provides funding to six agencies to support a regional perinatal system development including, coordination of resources for prenatal, delivery/birth, post-partum and newborn care. All maternity and newborn care hospitals, local health departments and other public health entities are assisted by the Regional Perinatal Centers Program. Grantees undertake activities in the areas of monitoring system performance, facilitating system development and resulting education. Perinatal Data Use Consortia have been formed to engage maternal and infant health professionals in a learning process to advance data knowledge and application to improve the quality of perinatal care across systems.  HYPERLINK "http://www.odh.ohio.gov/odhPrograms/cfhs/rpc/rpc1.aspx" http://www.odh.ohio.gov/odhPrograms/cfhs/rpc/rpc1.aspx StateRegional StructureWashington Washington has four Perinatal Regional Network contractors. Each of the four regional programs provides a licensed healthcare professional with expertise in neonatal and/or perinatal nursing or medicine to facilitate, coordinate, and support perinatal quality improvement within their regions and the state. The Perinatal Regional Network is coordinated by the Department of Health, Office of Maternal and Child Health, and is a collaborative effort with the Health and Recovery Services Administration/Medicaid. The program uses state and federal funds to contract with geographically strategic healthcare institutions to coordinate and implement state and regional quality improvement projects to decrease poor pregnancy outcomes for which Medicaid clients are at disproportionately increased risk. A leadership team, comprised of members from the agency and Medicaid, is responsible for strategic planning, contract management, and technical assistance for Perinatal Regional Network coordinators.  Based on the above information, it appears that other states generally employ a collaborative approach to perinatal regionalization, coordinated or led by departments of health in partnership with Medicaid (and possibly other) state agencies. Several states have established consortia of professionals with expertise in perinatal care to promote evidence-based, risk-appropriate care. Unlike these states, Michigan currently has no formal system for perinatal regionalization, although this was not always the case. Perinatal Regionalization: The Michigan Experience Michigan was a leader in regionalization of perinatal systems in the 1970s and 1980s. During that period, Michigan led the nation in pioneering the concept of a regionalized perinatal system. As previously described, Dr. Nigel Paneth conducted research at Michigan State University and demonstrated decreases in mortality of low birth weight babies receiving care in tertiary care centers. In 2005, the Michigan Department of Community Health initiated a collaborative effort with Grand Valley State University (GVSU) to conduct a regional perinatal survey. In the survey report (2007), MDCH and GVSU concluded that although Michigan once led the nation in the development of regionalized perinatal care, this was no longer the case, and no formal regional perinatal system existed in Michigan. At that time MDCH and GVSU concluded that high-technology NICU care made it possible to save the lives of low birthweight babies who previously might have died. The report also noted that highly sophisticated equipment and specialized staff are required to deliver care to these infants. The report recognized that regional perinatal networks were widely credited for a rapid decline in neonatal mortality over the previous 20 years and recommended organizing Michigans perinatal care geographically, with each geographic region having three levels of care: a level III hospital (often an academic medical center) to treat newborns in need of the highest level of intensive care; pregnant women would be identified early and transferred to a Level III facility. A Level II hospital would care for mothers and/or newborns with moderate complications. Level I hospitals would treat mothers and newborns with minor or no complications. MDCH and GVSU recommended rebuilding perinatal regionalization and developing detailed definitions and practice guidelines for levels of care based on the American Academy of Pediatrics guidelines and examining capacity and need to develop more well-defined and coordinated regions. Perinatal Regionalization: Fiscal Implications Evaluations of the impact of perinatal regionalization have primarily focused on the quality and safety of maternal and perinatal care, rather than fiscal analyses or return on investment. However, an article published by Lowery, Bronstein, McGhee, Ott, Reece, & Mays (2007) describing Arkansas process to improve perinatal regionalization cited studies demonstrating that regionalization is associated with decreased neonatal mortality and increased cost efficiency. Lowery, et. al intend to further study the Arkansas experience using a combined cost-effectiveness and cost-utility analysis and predicted decreased cost of maternal and fetal care. Similarly, the Brookings Institution (2009) indicates regionalized perinatal care is inherently cost effective, utilizing graded levels of care according to need. Formal study is necessary to fully understand the fiscal implications of a regional perinatal system in Michigan in the 21st century. However, some assumptions have been made about resource needs in an effort to estimate costs related to beginning the process of establishing a regional perinatal system in our state. Michigans regional perinatal system (MRPS) will serve as a guide for a quality improvement process and will work to supportively reinforce efforts for improving quality in neonatal, obstetric, and perinatal care. The Vermont Oxford Network (VON) is a recognized model to follow for a statewide quality improvement process. VON is a non-profit voluntary collaboration of health care professionals dedicated to the mission of improving the quality and safety of medical care for newborn infants and their families through a coordinated program of research, education and quality improvement projects. Established in 1988, the Network is today comprised of over 650 Neonatal Intensive Care Units around the world. Currently, Michigan has tertiary centers participating in VON, and the new leadership team has a state representative. This sets the stage for further collaborative efforts among hospitals, as well as between private and public sectors. Collaboration with this organization of committed professionals will occur by establishing a Michigan state section of the VON, including all tertiary centers in the state. Michigan has 24 hospitals with neonatal intensive care beds or tertiary centers. These hospitals will be provided a match for the cost of membership in the Vermont-Oxford Network (low birth weight and expanded databases) or comparable Quality Improvement entity and will be required to collect defined data fields for review and analysis. Using recommendations from leading Michigan professionals in the field of perinatal care, a core set of hospitals will be designated perinatal centers. These will serve as regional training and consultation sites for the state to assure the standard of care is being followed by all professionals providing perinatal care for women and infants. These sites will also support efforts for quality improvement within the states perinatal care system. Regular reports will be generated describing the picture of Michigans perinatal care and sharing data. State support will be provided to the MRPS. The AAP/ACOG Level of Care Guidelines modified to reflect Michigans standard of perinatal care have been recommended for adoption. These guidelines will require regular review to assure they continue to represent the current, evidence based approach for perinatal care. A consortium of Michigans professional perinatal experts will convene to conduct the recommended review at designated intervals to be determined. Estimated Cost: Michigan The following is a preliminary estimate of resources needed to initially implement a state regionalized perinatal system. Ongoing program sustainability and care costs are not included in this estimate. Resources to support the recommended state authorization component will be required. The cost of this will need to be determined. It is clear that ongoing review and study will be required to have a more defined picture of the cost, return on investment, and total fiscal implication of this recommended change. Resource Estimated CostRegional System Support 24 NICU hosp. x $8K 93 birthing hosp x $4K Neonatal/Pediatric/Obstetric $564,000Training  150,000Supplies 50,000MDCH Staffing Nurse Consultant 13, with special cert. (Lead Worker) 1.0 FTE Data Analyst 12 0.5 FTE  108,000 32,000Data Support  96,000TOTAL$1,000,000 Guidelines for Perinatal Levels of Care To fulfill the requirements specified in Section 116 of PA 246, 2008 and consistent with recommendations from MDCH and GVSU (2007), MDCH convened work groups of clinical experts in neonatal, obstetrical, and pediatric specialties in early 2009. These work groups were charged with modifying the current, evidence-based levels of care guidelines published by ACOG and AAP to reflect Michigan specific standards of perinatal care as a foundation for the States coordinated perinatal system. There are specific advantages to developing Michigan levels of care guidelines: Standard definitions will permit comparisons for health outcomes, resource utilization, and costs among institutions. Standardized nomenclature will be informative to the public, especially high-risk maternity patients who may seek an active role in selecting a delivery service. Uniformity in definitions of levels of care published by a professional organization will minimize the perceived need for businesses that purchase health insurance for their employees to develop their own standards. Uniform definitions will facilitate the development and implementation of consistent standards of service provided for each level of care. These Michigan guidelines include strategies to improve access to service, identify risk early, provide linkage to the appropriate level of care and ensure compliance, continuity and comprehensiveness. Proposed Guidelines and Discussion The following is a summary of the discussion and recommendations for Michigans evidence-based perinatal levels of care guidelines from each specialty workgroup. Obstetrics The Obstetric Workgroup was asked to Michiganize the level of care guidelines for obstetric units as a foundation for a state coordinated perinatal system. These levels are based on the concepts put forth by the AAP/ACOG in their jointly published book Guidelines for Perinatal Care (Blue Book, 2007), with details based on what the subject matter experts agreed are appropriate to Michigan. It was noted that regionalization affords better access, appropriate levels of care (i.e., higher level of care when needed) and improves outcomes. Michigans unique geographic challenges must be considered, which differ from many states with a regional system. The 1982 guidelines developed by the Michigan State Medical Society are now 25 years old, and hospital competition is present factor. The literature describes trends seen in the State of Michigan. Gould, et. al (2002) described the California experience, where live births at hospitals with community NICUs (Level 2+) increased from 11.7% to 37.4%. Births and very low birth weight (VLBW) births at regional NICUs decreased. No significant difference was seen in neonatal mortality of VLBW infants at community or regional NICU hospitals, but increased mortality was noted for VLBW infants delivered at institutions with lower levels of care. There was a difference between self-designated NICU services and care designation by a team of public health workers and neonatologists. There is a range of conclusions, but optimal delivery of a high risk neonate (750 1250 grams birth weight) is in a tertiary care center. In utero transfers are optimal (due to lower morbidity & mortality). This extends to birth weight less than 2000 grams, where mortality was higher if delivered in hospital with no NICU (odds ratio (OR) 2.38), intermediate NICU (OR 1.92), or community NICU (OR 1.42) (Cifuentes, et. al, 2002). Other factors contributing to mortality and morbidity include maternal socio-behavioral risk which accounted for 73 percent of the variation in hospital fetal death rates and 38 percent of hospital neonatal mortality rates. Inborn VLBW and neonatal transport had significant, independent effects on both hospital fetal death rate and hospital neonatal mortality rate. The workgroup agreed that the State must designate level of care for hospitals. Hospitals cannot self-designate, and hospitals should be required to go through a state established process. Rural issues were noted, including consideration of the availability of competent ultrasound, decision challenges, American Institute for Ultrasound and Medicine (AIUM) Guidelines, and obstetric-experienced radiology. The workgroup recommended examining the quality of prenatal care as a next step. The workgroup also stressed that inter-connectivity within regions is needed, including electronic medical records to share and discuss patient care. Quality performance measures for monitoring outcomes should incorporate the knowledge that the largest impact on maternal and fetal outcomes may relate to access to prenatal care, preterm birth rates, and delivery of preterm infants in a facility able to provide appropriate intensive neonatal care. Specific indices to consider are: Delivery volumes Gestational age and birthweight range at delivery (and number outside the defined level) B-methasone administration prior to delivery in <34 weeks intact membranes and <32 weeks ruptured membranes Group beta strep (GBS) prophylaxis Unexpected transfers of neonate to higher level facility after delivery Use of 17-OH progesterone prophylaxis in patients with history of prior non-iatrogenic (spontaneous) preterm singleton birth Fetal trauma/birth trauma Elective delivery via induction or cesarean section prior to 39 weeks gestation Prenatal care (gestational age at onset) The Obstetrics Workgroup also stressed that maternal mortality and morbidity are important indicators of health status in Michigan. A 1998 report from the CDCs National Center for Health Statistics indicated that in the U.S., the annual maternal mortality ratio remained approximately 7.5 maternal deaths per 100,000 live births during 1982-1996. Maternal mortality ratios (MMR) were also higher for black women (18 to 22 per 100,000 births) than for white women (5 to 6 per 100,000 live births); this disparity remains, with the Black/White MMR ratio consistently greater than two across all characteristics analyzed. Surveillance data from 2004 (MDCH, 2006) indicate Michigans Black/White ratio was 4.5 (White MMR 38.4 compared to Black MMR of 182.5). According to the December 2006 MMMS report, primary causes of maternal death in Michigan include obstetric embolism (15.2%), hypertension during pregnancy (13.1%), cardiomyopathy in puerperium (13.1%), and hemorrhage (7.1%). Maternal death as a result of accidents (57.4%), assaults (27.7%), and intentional self-harm (11%) were also identified as significantly contributing to maternal death. Data suggest that maternal deaths could be prevented through changes in the health and behavior of women before, during and after delivery through early diagnosis and appropriate medical care. Womens health must be optimized prior to conception, planned or not. Doing so means promoting womens health over the lifespan and across the entire spectrum of public health programs. For instance, preconception health of women became a key public health strategy in the United States to decrease morbidity and mortality associated with adverse maternal and infant outcomes. In 2006, the Centers for Disease Control and Prevention published ten recommendations for improving the health of women before pregnancy that are being used by state public health agencies, including the Michigan Department of Community Health, in developing policies and programs to address preconception health. Evaluation plans of these policies and program efforts will be developed and implemented along with the continued assessment of preconception health among women. Due to the scope of this report, these issues are not reflected in Attachment A, Michigan Perinatal Level of Care Guidelines but must be considered in future activities around clinical guidelines addressing maternal and child health. Obstetric guidelines are included in Attachment A, Michigan Perinatal Level of Care Guidelines. Neonatal/NICU The neonatal/NICU workgroup based its guideline recommendations on those outlined by the American Academy of Pediatrics (AAP) in Levels of Neonatal Care (2004) and in the Sixth Edition of Guidelines for Perinatal Care by the AAP and the American College of Obstetrics and Gynecology. Michigan guidelines developed by the Neonatal/NICU workgroup are delineated in Attachment A, Michigan Perinatal Level of Care Guidelines. These Michigan modified guidelines divide neonatal care into the following six categories based on level of care provided: I, IIA, IIB, IIIA, IIIB, and IIIC, with level I units able to care for normal newborns and level IIIC units caring for newborns with the most severe or complex illnesses. The Neonatal/NICU subgroup reported that some NICUs in Michigan care for babies outside the scope of the new guideline definitions and may need to adjust the acuity of babies cared for in their units. Specifically, several level IIIA NICUs (so categorized because they do not have pediatric surgeons or multiple pediatric subspecialists) care for babies of less than 29 weeks gestation, even though the AAP Committee on the Fetus and Newborn guidelines require such premature babies to be cared for in level IIIB or IIIC NICUs. The workgroup endorsed the AAP recommendation for Michigan. One of the intents of this document and the Michigan Perinatal Level of Care Guidelines is to provide a framework to define and evaluate the level of perinatal care delivered by hospitals and to ensure that care meets specific level of care criteria. The Neonatal/NICU subgroup stressed the need for the State to have a mechanism to oversee and enforce these categories. Currently, the State certifies neonatal intensive care units (NICUs) through the Certificate of Need (CON) process and designates some hospitals for a certain number of NICU beds. However, the designation and CON make no mention of the level of care that can be provided by the NICU. The subgroup also recommended that any revised CON process should be able to retrospectively change a hospitals NICU designation. That is, even if a new mechanism to issue CONs designating NICU levels is developed, a hospital issued a CON under the previous system using NICU beds could not maintain its NICU designation without conforming to new standards. The following are recommendations for state oversight and regulation of the perinatal care system: The State of Michigan should establish a Perinatal Guidelines Advisory Committee to continually review and update the Michigan Perinatal Level of Care Guidelines and provide recommendations for hospital level of care designation. The State of Michigan should designate an oversight body to review and make determinations regarding a hospitals perinatal level of care certification. Hospitals participating in the regionalized system of perinatal care shall comply with the guidelines approved by the advisory committee for perinatal guidelines for the level of care selected by the hospital. The statewide perinatal health care program oversight body should perform periodic on-site verification surveys of perinatal service programs to verify the hospital continues to meet level of care criteria. Results of each survey shall be submitted to MDCH, along with a recommendation to continue, suspend, or revoke the hospitals perinatal certification. Hospital perinatal certification information should be made available to the public to ensure transparency and to assist consumers in selecting appropriate perinatal hospital. Work in collaboration with EMS/trauma system to assure that each perinatal patient get to the right place in the right time. The following are recommended requirements for a hospital to be reviewed for a new perinatal level of care designation: Submit the following information to a Perinatal Guidelines Advisory Committee: Description of the geographic area to be served Identification of the target population to be served Identification of Level I hospitals to be served Identification of any overlap with existing higher level hospitals and/or centers Identification of unmet needs of the area to be served Demonstration of the ability to meet the most recent perinatal guidelines In summary, the Neonatal/NICU workgroup concluded that the State of Michigan should develop a method of authoritative recognition of different levels of NICU care, as well as a mechanism to insure that hospitals and NICUs care for only those neonates for which they are qualified. This would optimize care, potentially contributing to improved neonatal mortality rates, and provide health care consumers with reliable information when selecting a hospital. Neonatal guidelines are included in Attachment A, Michigan Perinatal Level of Care Guidelines. Pediatrics/Infancy The Pediatrics/Infancy workgroup focused much of its attention on discharge/transition to home and follow-up for NICU graduates, noting that the transition from the NICU to home can be challenging and stressful, and with few exceptions, families require assistance in adjusting to the reality of caring for their infant(s) at home. They stressed the availability of social support as an essential component for the success of every parents adaptation to the home care of a high-risk infant. By suggesting support services or parental support groups, providers may assist parents in coping with the stresses of uncertainty regarding their individual situation and their childs anticipated outcome. Because of the emotional turmoil that having an infant in a NICU can cause, parents and caregivers often find benefit in joining support groups. Programs for social services, developmental disabilities, home nursing, respite, spiritual services and economic assistance are often needed, as well. A NICU discharge conference should be held with hospital representatives and appropriate community resource representatives such as Early On, CSHCS, MIHP and the medical home provider. Although connections to such resources (both public and private) should be made prior to discharge, post-discharge support is needed to assure continued access to service and to reduce barriers to services that the families may encounter. This should be an integral part of pre/post discharge home visits, as well as the NICU Follow-up Clinic visits. Transition to Home The Pediatrics/Infancy workgroup recommended that the following activities occur prior to discharge/transition: 1. Create necessary relationships between NICUs and community agencies/entities Establish a relationship between NICUs and early intervention. Identify a core team (may be comprised of members from the hospital and/or community setting; a combination allows for better linking of the patient and family in both settings) 2. Define and communicate roles of hospital personnel, NICU Follow-up Clinic and community providers, including programs and services like early intervention (or similar early intervention programs). Mechanisms to create these relationships will vary by community but may include formal memoranda of agreement. Create a follow-up core team, to include: Parent Physician (ideally a developmental pediatrician) Physical Therapist and Occupational Therapist Speech/language pathologist to evaluate language development and feeding Psychologist for neurodevelopmental testing and interpretation Nutritionist (or WIC Registered Dietitian) Social Worker Registered Nurse (care coordinator) Audiologist or staff trained to do objective hearing assessment 4. Create a system to ensure that follow-up NICU care is available to all patients who meet criteria Review existing guidelines/best practices, including the follow up core team composition A NICU neonatal follow-up clinic should be attached to the highest level of infant care based on the guidelines All level 3 NICU's should have a Neonatal Follow-Up Clinic Level 1 and 2 NICU's should have a referral arrangement with a Neonatal Follow-Up Clinic Ensure the availability of regional neonatal follow-up clinics and satellites (as determined by regional clinic) Establish standards for neonatal follow-up clinics; determine process for approval and oversight Ensure NICU follow-up clinics have the capacity for complete evaluation (medical and developmental) Evaluate the need to license or certify follow-up neonatal clinics and determine process(es) 5. Develop a comprehensive discharge plan prior to NICU discharge, based on the following considerations Refer all NICU graduates to a neonatal follow-up clinic at discharge Level I Nursery Transition plan to home Assessment if home visit is needed Referral to a regional neonatal follow-up clinic if a back transfer and meets follow-up criteria Level II Nursery Transition plan to home Assessment if home visit is needed. Referral to a regional neonatal follow-up clinic if a back transfer and/or meets follow-up criteria Level III Nursery Transition to home plan Coordinate with public health and other community resources the provision of home visitation prior to discharge and one to two weeks after discharge for all Level III babies. Must have a neonatal follow-up clinic with appropriate staffing, linked with early intervention system. The discharge planning team should include: Parents Case Manager Social Worker Hospital Nurse Home Nurse Neonatologist/Pediatrician Other professional staff as needed. Prior to discharge, discuss the follow up care plan, including the designation of a primary care physician, and make appointments with appropriate pediatric subspecialists (e.g. pediatric pulmonologist for infant with chronic lung disease, cardiologist for cardiac anomaly, etc.). This is particularly important for infants that will not be followed and managed for a subspecialty condition in a neonatal follow-up clinic. It is prudent that a subspecialist see the patient in the NICU prior to discharge so that continuity may be maintained between neonatal care and pediatric subspecialty care. If a patients subspecialty condition (e.g. chronic lung disease) is managed by neonatologists in a NICU follow up clinic, every attempt should be made to systematically transition the care of that infants condition to a subspecialist through direct communication between providers and, ideally, joint clinic visits at a time in the patients clinical course, deemed appropriate by the neonatal provider. Obtain parental permission for release of information to early intervention and other appropriate services. Early intervention services should be in place before discharge; refer to early intervention prior to discharge Coordinate care and arrange for any needed services, including transportation (which should be free to the parent) If distance to or lack of a neonatal follow-up clinic is an issue, consider telemedicine options for follow-up Conduct necessary screening (e.g., hearing and vision) Enter hearing and vision screening results into a database (such as the Michigan Care Improvement Registry, MCIR) Follow-up 1. Criteria for infant to be referred to Neonatal Intensive Care Follow-up clinic: Preterm: VLBW d" 1500 grams or less than 32 weeks gestation Infants with cranial ultrasound abnormalities, including periventricular, leukomalacia/ intraventricular hemorrhage and linear hyperechogenicity Other neurologic problems (seizures, hydrocephalus) Necrotizing enterocolitis Chronic lung disease Complex medical problems Hyperbilirubinemia requiring exchange transfusion Failure to grow in the NICU Culture proven sepsis, meningitis and nosocomial infections Abnormal neurologic exam at discharge Term: Encephalopathy persisting at discharge Other neurologic problems/seizures and hydrocephalus Complex medical problems Twin-twin transfusion Complex congenital anomalies Meningitis Hyperbilirubinemia requiring exchange transfusion Abnormal neurologic exam at discharge Extracorporeal Membrane Oxygenation Other infants or preterm infants where there are significant concerns from the medical team should be referred for follow-up. Ideally all infants with level III acuity would be referred to early intervention for ongoing follow-up between the time of discharge and their visit in the follow-up clinic. 2. The following is a recommended schedule for comprehensive visits in the NICU follow-up clinic: 6-8 months 12-14 months 18-24 months 3 years After 3 years (if there are persisting concerns) refer to another center (depending on the specific concern(s), e.g., cerebral palsy, autism, etc.) Pediatrics guidelines are included in Attachment A, Michigan Perinatal Level of Care Guidelines. Recommendations As discussed in the previous pages of this document, in summary, the Michigan Perinatal Care workgroups recommend that Michigan: Adopt the Michigan Perinatal Level of Care Guidelines. Develop a method of authoritative recognition of levels of NICU care and establish a statewide mechanism to oversee and enforce adherence to the Michigan guidelines to ensure that hospitals and NICUs care for only those mothers and neonates for which they are qualified The Guidelines should be periodically reviewed and updated as new data occur and recommendations from national groups are made. If the authoritative recognition of levels of care is through the Certificate of Need process, Create a provision to retrospectively change a hospitals perinatal level of care designation All Level III NICUs should have a NICU Follow-up Clinic Standards for the NICU Follow-up Clinics should be developed and the State should develop a mechanism for authoritative recognition of the NICU Follow-up Clinic Ensure that NICU Follow-up Clinics have the capacity for complete evaluation, both medical and developmental NICU follow-up care should be covered by insurance, including neurodevelopmental testing, to assure continued access to care and to reduce barriers to services. The state should allocate funds so that all Level III babies receive home visits. Educate medical providers about the needs of NICU graduates Support the enrollment of all NICUs in Vermont Oxford Network Develop a mechanism for follow-up of privately insured infants Utilize available data (e.g., Public Health Surveillance system, Medicaid data warehouse, etc.) and track outcomes on key indicators, such as long-term effect of NICU care/treatment and infant mortality Develop a system to follow-up on NICU graduates, including: Create a mechanism to capture all child/family services in one record, with information from all providers coordinated and shared. Connect to MDCH Health Information Technology Project to track outcomes, especially the long-term effects of NICU care/treatments and infant mortality. An electronic record is ideal, or use a database such as the Michigan Care Improvement Registry (MCIR). The State of Michigan should address the critical shortage of nurses in the state and conduct ongoing evaluations of staffing shortages and potential impact on the provision of care. Convene an annual conference or meeting with representatives from all Levels of Care to review and provide education regarding the guidelines and areas for improvement in the care to obstetric patients, neonatal and pediatric care. Convene representatives from all entities involved in the delivery of optimal healthcare to women and children at regional and state levels to discuss barriers to optimal care and mechanisms to resolve those barriers Work in collaboration with EMS/trauma system to thus assure that each perinatal patient get to the right place in the right time. There is currently an internal collaborative effort at MDCH that will lead to a better understanding of the common venues for further coordination. Conclusions Creating a system for regionalized perinatal care is an approach consistent with evidence-based guidelines promulgated by the American Academy of Pediatrics and the American College of Obstetrics and Gynecology and successfully adopted by other states. This approach ensures that hospitals and NICUs operate within appropriate, clearly defined level of care designations and ensures collaboration among regional entities providing services to women, neonates/infants and families. Convening subject matter experts in OB, Neonatology, and Pediatrics was a unique opportunity to examine pediatric regionalization in Michigan. This collaborative approach also established a venue to develop comprehensive Michigan perinatal guidelines and obtain valuable recommendations for policy improvements in the area of perinatal care. APPENDIX A Michigan Perinatal Level of Care Guidelines LEVELS OF CARE Neonatal and Maternal  Level I (Basic) Community-Based Maternal-Newborn Service Level II A (Specialty) Community-Based Maternal-Newborn Service with a Special Care NurseryLevel II B (Specialty) Community-Based Maternal-Newborn Service with a Special Care NurseryLevel III A (Subspecialty) Perinatal Care Center and Neonatal Intensive Care UnitLevel III B (Subspecialty) Perinatal Care Center and Neonatal Intensive Care Unit with Neonatal Subspecialty ServiceLevel III C (Subspecialty) Perinatal care center or Freestanding Pediatric Hospital with Neonatal Subspecialty ServicePATIENT POPULATIONNeonatalGestation/weight/risk Level I Greater or equal to 35 weeks gestation in pregnancies unlikely to deliver before 35 weeks gestation that have a low likelihood of neonatal or maternal morbidity. Care of the physiologically stable infants and normal newbornsLevel II A Level I + Greater than 32 weeks gestation and weighing more than 1,500 grams (uncomplicated preterm infant with problems that are expected to resolve rapidly not needing urgent subspecialty service)Level IIB Level I + Greater than 32 weeks gestation and weighing more than 1,500 grams (uncomplicated preterm infant) Level IIIA Level II + Greater than 28 weeks gestation and weighing more than 1,000 grams Level IIIB Level III A + Less than 28 weeks gestation and weighing less than 1,000 grams or who have severe or complex illnesses Level IIIC Level III A + Less than 28 weeks gestation and weighing less than 1,000 grams or who have severe or complex illnesses Minimum number of VLBW infants per yearNANANA157070MATERNALGestation/weight/risk Level I Pregnancies > 35 weeks gestation in pregnancies unlikely to deliver before 35 weeks gestation that have low likelihood of neonatal or maternal morbidity Level II A Pregnancies >32 weeks gestation in selected high-risk pregnancy conditions judged unlikely to deliver before 33 weeks with low risk of neonatal or maternal morbidityLevel IIB Pregnancies >32 weeks gestation in selected high-risk pregnancy conditions judged unlikely to deliver before 33 weeks with low risk of significant neonatal or maternal morbidityLevel III A Pregnancies >28 weeks gestation in women without significant co-morbidities Level III B Pregnancies all gestational ages and all maternal conditionsLevel III C Pregnancies all gestational ages and all maternal conditions SURGERIES/PROCEDURESNeonatalIntensive care support (higher level neonatal care above that of the perinatal service is acceptable due to geographical distance or demography)Level I Stabilization of sick newborn infants until transfer only Surgery: NA Level II A Stabilization of sick newborn infants until transfer only Surgery: NA Level II B Level II A + CPAP and mechanical ventilation for less than 24 hours Surgery: NA Level III A Level II B + CPAP and conventional mechanical ventilation Surgery: minor central line and hernia repairLevel III B Level III A + high frequency ventilation (HFV), inhaled nitric oxide (iNO) Surgery: Level III A + pediatric surgeryLevel III C Level III B + ECMO (Extracorporeal membrane oxygenation) and cardiac surgery. Surgery: Level III B + open cardiac surgery.MATERNALTriage systemLevel I Experience obstetric Registered Nurse with physician availability within 30 minutesLevel II A Experienced obstetric Registered Nurse with physician availability within 30 minutesLevel II B Experienced obstetric Registered Nurse with physician availability within 30 minutesLevel III A Experienced obstetric Registered Nurse with physician available in hospital for consult or directly providing service. Midlevel care provider (CNM, NP, or PA) or physician is available to triage patients transferred from lower level health care facility.Level III B Experienced obstetric Registered Nurse with physician available in hospital for consult or directly providing service. Midlevel care provider (CNM, NP, or PA) or physician is available to triage patients transferred from lower level health care facility.Level III C Experienced obstetric Registered Nurse with physician available in hospital for consult or directly providing service. Midlevel care provider (CNM, NP, or PA) or physician is available to triage patients transferred from lower level health care facility. Cesarean Section Level I Within 30 minutes of decision and appropriate to the current clinical situationLevel II A Within 30 minutes of decision and appropriate to the current clinical situationLevel II B Within 30 minutes of decision and appropriate to the current clinical situation Level III A Within 30 minutes of decision and appropriate to the current clinical situation Level III B Within 30 minutes of decision and appropriate to the current clinical situation Level III C Within 30 minutes of decision and appropriate to the current clinical situation Intensive Care Support NoNoNoNoRequired (does not require a dedicated obstetric unit)Required (does not require a dedicated obstetric unit) HOSPITAL ORGANIZATIONNeonatal and MaternalOrganizationAll Levels Hospital's Board of Directors, administration, and medical and nursing staff shall demonstrate commitment to its specific level of perinatal center designation and to care of perinatal patients. This commitment shall be demonstrated by: A Board resolution that the hospital agrees to meet the Michigan Department of Community Health Perinatal System Standards for its specific level of designation. Assurance that all perinatal patients shall receive medical care commensurate with the level of the hospital's designation. A Board resolution, bylaws, contracts, budgets - all specific to the perinatal program - indicating the hospital's commitment to the financial, human, and physical resources and to the infrastructure that are necessary to support the hospital's level of perinatal center designation. The hospital shall obtain and maintain current equipment and technology, as described in these standards, to support optimal perinatal care for the level of the hospital's perinatal center designation. Participation in the Michigan Perinatal System as described by this document including submission of clinical outcome data to the Michigan Department of Community Health as appropriate for system and quality management. Hospital shall be licensed by the Michigan Department of Community Health as an acute care hospital Accredited by nationally recognized accreditation organization (e.g., JCAHO, AOA) NeonatalTransport Meet the requirements of the most current version of the Guidelines for Perinatal Care (6Th edition, chapter 3). All Levels Demonstrate on-going relationship with referral hospitals for immediate consultation, urgent transport. Written policy for transport including triage system for identifying at risk patients and transferring to appropriate level of care facility. Ensure a providers continuing responsibility for care until transport team assumes full responsibility. Provide communication and recommendations for ongoing patient care at discharge. If maternal or neonatal air transports are accepted, then the hospital shall have a heliport, helipad, or access to a helicopter landing site near the hospital. Patients whose condition has stabilized and no longer require specialized services should be considered for transporting back to the referring hospital. NICU Transition and DischargeLevel I, Level II A, Level II B Must have a relationship or memorandum of understanding with a NICU follow-up clinicLevel III A, Level III B, Level III C Must have a NICU follow-up clinicEducation for the Region: The staff of regional centers shall provide perinatal educational programs in both maternal and neonatal care in the region on a regular basis.Level I, Level II A, Level II B NA Level III A, Level III B, Level III C Requirement for regional perinatal center: Review major perinatal conditions, their medical treatment and nursing care. Review of perinatal complications and outcomes. Feedback for all transports and frequency of failure to transfer appropriately to tertiary care center.MATERNAL Transport Level I Relationship with Level 2B and/or Level 3A,B,C hospitals to facilitate/coordinate maternal transport out; responsibility for care continues until care assumed by receiving hospital -Stabilization and transport for unexpected maternal problems consistent with ACOG guidelines -Establish guidelines /procedures for identifying patients at risk who should be transferred -Transfer via advanced life support if felt appropriate to the clinical situationLevel II A Relationship with Level 2B and/or Level 3A,B,C hospitals to facilitate/coordinate maternal transport out; responsibility for care continues until care assumed by receiving hospital -Stabilization and transport for unexpected maternal problems consistent with ACOG guidelines -Establish guidelines /procedures for identifying patients at risk who should be transferred and (in case of diversion) necessary communication from upper level to lower level unit -Transfer via advanced life support if felt appropriate to the clinical situationLevel II B Relationship with Level 3A,B,C hospitals to facilitate/coordinate maternal transport out and with Level 1, 2A for transport in; responsibility for care continues by referring hospital until care assumed by receiving hospital -Stabilization and transport for unexpected maternal problems consistent with ACOG guidelines - Establish guidelines /procedures for identifying patients at risk who should be transferred and (in case of diversion) necessary communication from upper level to lower level unit -Transfer via advanced life support if felt appropriate to the clinical situationLevel III A Relationship with Level 3B,C hospitals to facilitate/coordinate transport out and with Level 1, 2A,B from transport in; responsibility for care continues by referring hospital until care assumed by receiving hospital - Maintain 24 hour system for reliable comprehensive communications between hospitals for immediate consultation and approval of transports - Establish guidelines /procedures for identifying patients at risk who should be transferred and (in case of diversion) necessary communication from upper level to lower level unit - Involvement in statewide perinatal educational outreach programs in both OB and neonatal specialties in collaboration with the Michigan Dept HealthLevel III B Relationship with Level 3C hospitals to facilitate/coordinate maternal transport out and with Level 1 through 3A for transport in; responsibility for care continues by referring hospital until care assumed by receiving hospital - Maintain 24 hour system for reliable comprehensive communications within and between hospitals for immediate consultation and approval of transports and within systems (i.e., EMS) - Involvement in statewide perinatal educational outreach programs in both OB and neonatal specialties in collaboration with the Michigan Dept Health Level III C Relationship with all other levels to facilitate/coordinate maternal transport in; responsibility for care continues by referring hospital until care assumed by receiving hospital - Maintain 24 hour system for reliable comprehensive communications within and between hospitals for immediate consultation and approval of transports and within systems (i.e., EMS) - Involvement in statewide perinatal educational outreach programs in both OB and neonatal specialties in collaboration with the Michigan Dept Health UNIT CAPABILITYNeonatalEquipment, Supplies, and Personnel (The hospital shall demonstrate its capability of providing uncomplicated and complicated neonatal care through written standards, protocols, or guidelines.)Level I, Level II A Resuscitation and stabilization of unexpected neonatal problems according to most current Neonatal Resuscitation Program (NRP) guidelines. Selection and management of neonatal patients at a neonatal risk level appropriate to its capability - Antibiotic administration, Glucose management, IV fluid administration, Oxygen administration, Thermoregulation, Sepsis Evaluation (blood draws, lumbar puncture), Provision for parental contact prior to transfer etc.Level II B Level II A + Capability to include 1. Mechanical ventilation (<24 hrs) and nCPAP. 2. Umbilical linesLevel III A Level IIB + 1. Capability for prolonged mechanical ventilation 2. Minor surgery central line or inguinal hernia repairLevel III B Level III A + 1. Management of all neonatal patients, including those requiring advanced modes of neonatal ventilation and life support, pediatric subspecialty services, 2. Advanced imaging and interpretation 3. Development and evaluation of new technology and therapiesLevel III C Level III B + Pediatric subspecialty surgical services such as pediatric cardio-thoracic open-heart surgery, pediatric organ transplant and neurosurgeryMATERNALLabor and Delivery Level I Electronic fetal monitoring capabilities Level I Ultrasound (US) available to delivery area with appropriate support staff and equipment Level II A Electronic fetal monitoring capabilities Level II A Limited US services available in delivery area Level IIB Electronic fetal monitoring capabilities Level II B Limited ultrasound services available in delivery areaLevel III A Electronic fetal monitoring capabilities Level III A - US available in L&D -Advanced level ultrasound available on-siteLevel III B Electronic fetal monitoring capabilities Level III B - US available in L&D -Advanced level ultrasound available on-siteLevel III C Electronic fetal monitoring capabilities Level III C - US available in L&D - Advanced level ultrasound available on-site PERSONNELNeonatalLeadershipLevel I Physician with board-certified in pediatricsLevel II A Physician board-certified in pediatrics or in neonatal-perinatal medicineLevel II B, Level III A, Level III B, Level III C Physician board-certified in neonatal-perinatal medicineCoverage for Urgent Neonatal IssuesLevel I, Level II A 1. Pediatrician, 2. Family practitioner.Level II B 1. Neonatologist on call, 2. Pediatrician or NNP / PA shall be immediately available when neededLevel III A, Level III B, Level III C 1. Neonatologist to be available in-house within 30 minutes, 2. Pediatrician or NNP / PA or Neonatal Fellow (personnel qualified to manage emergencies) shall be immediately available in-house 24 hours a day.Subspecialty StaffLevel I, Level II A The hospital shall have written consultation and referral agreements in place with pediatric cardiology, Level II B The hospital shall have written consultation and referral agreements in place with pediatric cardiology and Genetics.Level III A The hospital shall have on staff an ophthalmologist with experience in neonatal retinal examination and a written consulting relationship with pediatric cardiologist(s), genetics, and surgeon(s) etc.Level III B The hospital shall have the following pediatric specialists on staff, in active practice and, if needed, in-house within 30 minutes or be urgently available at a closely related institution for consultation and care: Pediatric subspecialists: cardiology, neurology, genetics, hematology, Infectious disease, endocrinology, pulmonary, Nephrology, gastrointestinal, renal, Pathology, pharmacology, ophthalmology and Pediatric surgery: General and subspecialists. Level III C Level III B + pediatric surgical subspecialists: neurosurgery, cardiothoracic surgery, orthopedic surgery, plastic surgery, ophthalmology and ECMO team.Nursing Staff Meet the requirements of the most current version of the Guidelines for Perinatal Care (6th Edition, chapter 2)All Levels A registered nurse skilled in the recognition and management of complications in newborns readily available to the Mother-Baby unit 24 hours a day. A registered nurse with demonstrated training and experience in the assessment, evaluation, and care of newborns readily available to the neonatal unit 24 hours a day. All nurses caring for ill newborns must possess demonstrated knowledge in observation and treatment of newborn to the appropriate level of care. Registered nurses in the NICU should have specialty certification or advanced training and experience in the nursing management of neonates at high risk, including stabilization of unstable neonate and multi-organ system problems and supportive of their families.Nursing Neonatal SurgeryLevel I, Level II A, Level II B NALevel III A, Level III B, Level III C A hospital perinatal program that performs neonatal surgery shall have nurses on staff with special expertise in perioperative management of neonates.Nurse-Patient Ratio Meet the requirements of the most current version of the Guidelines for Perinatal Care (6th Edition,)Level I Newborn requiring only routine well baby care 1:6-8 Normal mother-newborn couple care or breast-feeding care 1:3-4 Level II A Newborn requiring only routine care (well baby care) 1:6-8 Normal mother-newborn couple care or breast-feeding care 1:3-4Level II B Newborn requiring only routine care 1:3-4 Newborn requiring intermediate care 1:2-3 Newborn requiring intensive care 1:1-2Level III A, Level III B, Level III C Newborn requiring only routine care 1:3-4 Newborn requiring intermediate care 1:2-3 Newborn requiring intensive care 1:1-2 Newborn requiring multisystem support 1:1 Unstable newborn requiring complex critical care 1:1 or greaterAdministrative Nursing StaffLevel I BSN optimal; RN required for programmatic responsibility for the neonatal servicesLevel II A, Level II B BSN required for programmatic responsibility for the neonatal servicesLevel III A, Level III B, Level III C Shall have administrative staff, a RN with BSN preferably with a Masters or higher degree in nursing or a health related field and experience with high-risk neonatal nursing who shall have programmatic responsibility for the neonatal nursing services.MATERNAL L&D Medical DirectorLevel I Board certified or active candidate for board certification in Family Practice or OB/GYN Level II A Board certified or active candidate in OB/GYN or Family PracticeLevel II B Board certified or active candidate in OB/GYNLevel III A Board certified or active candidate in OB/GYNLevel III B Board certified or active candidate in OB/GYN or MFMLevel III C Board certified or active candidate in OB/GYN or MFMHospital medical Obstetric Care Providers on Staff Level I Family practice physician (with cesarean section privileges or general surgeon available for c/s in 30 minutes) Or Ob/Gyn or CNM with C/S back-up; Health care provider not in house 24/7 but available within 30 minutesLevel II A Obstetrician (Board certified or active candidate with ACOG or ACOOG) + Level I; not in house but available within 30 minutesLevel II B Obstetrician (Board certified or active candidate with ACOG or ACOOG) + Level I; not in house but available within 30 minutesLevel III A Obstetrician (Board certified or active candidate with ACOG or ACOOG) + Level I; physician is in house 24/7Level III B Maternal-Fetal Medicine (Board certified or active candidate with ACOG or ACOOG) + Level 2; physician is in house 24/7Level III C Maternal-Fetal Medicine (Board certified or active candidate with ACOG or ACOOG) + Level 2; physician is in house 24/7Maternal-Fetal Medicine supportLevel I Relationship allowing telephone consultation for immediate support as neededLevel II A Formalized working consultative relationshipLevel II B Formalized working consultative relationshipLevel III A Maternal-Fetal Medicine on staff for consultation or co-managementLevel III B MFM on staff for co-management, consultation, or primary managementLevel III C MFM on staff for co-management, consultation or primary managementAdministrative Nursing StaffLevel I BSN optimal; RN required for programmatic responsibility for the obstetrical and neonatal nursing servicesLevel II A, Level II B, Level III A, Level III B, Level III C BSN OTHER PERSONNELANESTHESIA Neonatal Level I NALevel II A NALevel II B NALevel III A, Level III B, Level III C If the hospital performs neonatal surgery, then a board-certified anesthesiologist with experience in neonatal anesthesia shall be present for the surgery. Maternal Level I Anesthesia available to begin c/s within 30 minutes of notification by Board certified or active candidate for certification in anesthesia on medical staff or CRNALevel II A Anesthesia available to begin c/s within 30 minutes of notification by Board certified or active candidate for certification in anesthesia on medical staff or CRNALevel II B Anesthesia available to begin c/s within 30 minutes of notification by Board certified or active candidate for certification in anesthesia on medical staff or CRNALevel III A Level 1 + 24/7 in house anesthesia with board certified or active candidate in anesthesiology or CRNA readily available to delivery areaLevel III B Level 1 +Dedicated obstetric anesthesia teamLevel III C Level 1 +Dedicated obstetric anesthesia teamRADIOLOGY SERVICES Neonatal Level I , Level II A, Level II B - Staff radiologist on call with daily availability Level III A, Level III B, Level III C The hospital shall have a physician on the medical staff with privileges for providing critical interventional radiology services. MaternalAll Levels -Staff radiologist on call with daily availabilityDIETITIAN Neonatal Level I OPTIONALLevel II A OPTIONALLevel II B OPTIONALLevel III A, Level III B, Level III C The hospital shall have a registered dietician or other health care professional with knowledge of and experience in neonatal parenteral/enteral management on staff. MaternalLevel I -Consultation availableLevel II A -Consultation availableLevel II B -Consultation availableLevel III A, Level III B, Level III C -On staff -one registeredSOCIAL WORKER Neonatal Level 1, Level II A, Level II B, Level III A The hospital shall have a licensed social worker with a Master's degree (MSW) and experience in psychosocial assessment and intervention with women and their families readily available to the perinatal service.Level III B, Level III C 1. The hospital shall have a licensed social worker with a Master's degree (MSW - for every 30 beds) and experience in psychosocial assessment and intervention with women and their families dedicated to the NICU, available 7 days / week. 2. Personnel skilled in pastoral care available as needed.  MaternalLevel I, Level II A, Level II B At least one MSW with relevant experience whose responsibilities include perinatal patients; specific personnel for discharge planning and education community follow-up referral process and home care arrangementsLevel III A Full time MSW with experience in socioeconomic and psychosocial problems of high risk mothers available 24/7Level III B, Level III C Dedicated obstetric/perinatal social worker with experience in socioeconomic and psychosocial problems of high risk mothers. Back-up MSW available 24/7 RESPIRATORY THERAPIST Neonatal Level I Respiratory therapist (RT) available 24/7Level II A RT available 24/7Level II B The hospital shall have respiratory therapists skilled in neonatal ventilator management available when an infant is receiving assisted ventilation. Level III A, Level III B The hospital shall have respiratory therapists skilled in neonatal ventilator management present or assigned in-house 24 hours a day.Level III C The hospital shall have respiratory therapists skilled in neonatal ventilator management assigned to the NICU and not shared with other units 24 hours a day. MaternalAll Levels RT 24/7GENETICS Neonatal All Levels The hospital shall have genetic diagnostic and counseling services or written consultation and referral agreements for these services in place.  MaternalLevel I, Level II A, Level II B -Genetic diagnostic and counseling services or written consultation and referral agreements for these services in place Level III A, Level III B, Level III C Genetic counseling with diagnostic prenatal testing PEDIATRIC NEURODEVELOPMENTAL FOLLOW-UPNICU Follow-Up Clinic Level I NALevel II A NALevel II B NALevel III A, Level III B, Level III C Core Team shall include: - Neurodevelopmental pediatrician as medical director of the clinic - Nurse Coordinator (RN) - Social Worker - Nutritionist or WIC RD - Psychologist - Physical and Occupational Therapist - Speech and Language Pathologist - Audiologist or staff trained to do objective hearing assessment Team members may come from the hospital or community setting.STAFF EDUCATORNeonatal All Levels A hospital perinatal program shall have nurses with special expertise in obstetrical and neonatal nursing identified for staff education. PHARMACY Neonatal Level I, Level II A 24 hours provision of access to emergency drugs. Registered Pharmacist with Neonatal pharmacology resources available by telephone consultation.Level II B 24 hours provision of access to emergency drugs. Registered Pharmacist with Neonatal pharmacology resources available in-house 7 days a week or available for telephone consultation.Level III A, Level III B, Level III C 24 hours provision of access to emergency drugs. Registered Pharmacist with Neonatal pharmacology resources available in-house 24 hours / 7 days a week . MaternalLevel I Registered pharmacist immediately available for telephone consultation 24/7 with provision for or access to emergency drugsLevel II A, Level II B, Level III A, Level III B, Level III C Registered pharmacist available 24/7 LACTATION MaternalLevel I Nursing or staff trained in lactation consultation -must have access to consultation with a lactation consultant certified by the International Board of Certified Lactation Consultants (IBCLC) -Must have hospital grade electric pump and collection kit -Policies for milk storageLevel II A Nursing or staff trained in lactation consultation -must have access to consultation with a certified lactation consultant (IBCLC) -Must have hospital grade electric pump and collection kit -Policies for milk storage Level II B Nursing or staff trained in lactation consultation -must have access to consultation with an IBCLC -Must have hospital grade electric pump and collection kit -Policies for milk storageLevel III A Dedicated consultantLevel III B Dedicated consultantLevel III C Dedicated consultantNON-OBSTETRIC SPECIALTY CONSULTATION MaternalLevel I General Surgery Family PracticeLevel II A, Level II B General Surgery Internal Medicine Level III A More complete range of consultative services for adults including but not limited to Pulmonary, GI, Cardiology, Infectious Diseases, etc Level III B, Level III C More complete range of consultative services for adults including but not limited to Genetics, pulmonary, GI, Cardiology, Infectious Diseases, etc Access to Pediatric Pathology ENGINEERINGNeonatal and Maternal All Levels The hospital engineering department should include electrical, mechanical and biomedical technicians who are responsible for the safety and reliability of the equipment. TRANSITION PLANNING and FOLLOW-UPNeonatalICU Transition and Discharge PlanningLevel I Transition plan to home Assess the need for a home visit Referral to a regional neonatal follow-up clinic if a infant is a back transfer and meets follow-up criteriaLevel IIA, Level II B Transition plan to home Assess the need for a home visit Referral to a regional neonatal follow-up clinic if a infant is a back transfer and meets follow-up criteria Level III A, Level III B, Level III C Transition plan to home Coordinate with public health and other community resources the provision of home visitation prior to discharge and one to two weeks after discharge for all Level III babies Must have a neonatal follow-up clinic with appropriate staffing, linked with early intervention system. Discharge Planning Team should include; Parent Case manager Social Worker Hospital Nurse Home Nurse Neonatologist/Pediatrician Other professional staff as neededAll Levels Help parents understand what to expect regarding development of their NICU infant. Prior to discharge, discuss feeding issues Reflux issues Calorie needs Follow-up care, including immunizations, and make follow-up appointments The childs medical home and what to expect regarding the specific challenges of the NICU graduate. When to be alarmed When to call the Doctor Resources available to the child Develop a detailed follow-up plan including the designation of a primary care physician and appointments with appropriate pediatric subspecialists Refer for CSHCS for services, as appropriate Referral to early intervention services Utilize a standardized tool to assess neurobehavioral status between 38 and 40 weeks gestation Give appropriate immunizations and discuss follow-up Establish a medical home Request a smoke free environment for the child Provide universal home visits to the NICU population, with one visit prior to discharge and at least one visit following discharge regardless of insurance. CRITERIA FOR NICU FOLLOW-UPLevel I, Level II A, Level II B Referral to a regional neonatal follow-up clinic if infant is a back transfer and meets follow-up criteriaLevel III A, Level III B, Level III C Criteria For infant to be referred to neonatal Intensive Care Follow-up clinic: Preterm: VLBW d" 1500 grams Infants with cranial ultrasound abnormalities, including periventricular, leukomalacia/ intraventricular hemorrhage and linear hyperechogenicity Other neurologic problems (seizures, hydrocephalus) Necrotizing enterocolitis Chronic lung disease Complex medical problems Hyperbilirubinemia requiring exchange transfusion Failure to grow in the NICU Culture proven sepsis, meningitis and nosocomial infections Abnormal neurologic exam at discharge Term: Encephalopathy persisting at discharge Other neurologic problems/seizures and hydrocephalus Complex medical problems Twin-twin transfusion Complex congenital anomalies Meningitis Hyperbilirubinemia requiring exchange transfusion Abnormal neurologic exam at discharge Extracorporeal Membrane Oxygenation Other infants or preterm infants where there are significant concerns from the medical team should be referred for follow-up. Ideally all infants with level III acuity would be referred to early intervention for ongoing follow-up between the time of discharge and their visit in the follow-up clinic. NICU FOLLOW-UP SERVICESAll Levels - Coordinate with public health and other community resources the provision of home visitation prior to discharge and one to two weeks after discharge for all Level III babies - Discuss family planning (make sure the mother has follow-up with OB) Assess ability to care for child Assess ability to get to medical appointments Assess/discuss sleep environment - Recommended Schedule for comprehensive visits in the NICU follow-up clinic: 6-8 months 12-14 months 18-24 months 3 years After 3 years if there are persisting concerns, refer to another center depending on the specific concern(s), e.g., cerebral palsy, autism, etc. LABORATORYNeonatalProcessing and Reporting TimeLevel I The hospital laboratory shall demonstrate the capability to immediately obtain appropriate samples, process, and timely report urgent/emergent neonatal laboratory requests.Level II A, Level II B Level I + 1. Lab Technician in house 24 hrs / day 2. Skilled phlebotomist available 24 hrs / day 3. Micro technique for hematocrit and blood gases with in 15 minutes.Level III A, Level III B, Level III C Comprehensive services available 24 hours / day.Hearing TestAll Levels The hospital shall have available the equipment and trained personnel to perform newborn hearing screening on all infants born at or transferred to the institution as required by the Universal Newborn Hearing Screening, Diagnosis, and Intervention Guidelines. The hearing test should be performed when the infant is term, even if still in the NICU and still on a ventilator. If being discharged before term, the test should be done at discharge. Maternal Level I The hospital laboratory shall demonstrate the capability to immediately obtain appropriate samples, process, and timely report urgent /emergent obstetric laboratory requests -Policy to report critical results -Standard maternal antepartum testing shall be available to the providers prior to discharge, if not will be performed during the hospitalization and available prior to d/c of neonate -Rapid HIV 24/7Level II A, Level II B Level I, plus Lab tech available 24/7 Phlebotomist available 24/7Level III A, Level III B, Level III C Comprehensive lab services available 24/7 with established network BLOOD BANK Neonatal All Levels Blood bank technicians shall be present in-house 24 hours a day. MaternalLevel I -provision for emergent availability of blood products -techs present 24/7Level II A, Level II B, Level III A, Level III B, Level III C 24 hour/day availability of blood productsGENETIC TESTINGNeonatal and MaternalAll Levels The hospital shall have molecular, cytogenetic, and biochemical genetic testing available or written consultation and referral agreements for these services in place. Completion of state required metabolic screening.IMAGING CAPABILITIESNeonatalPortable X-Ray and UltrasoundAll Levels Portable x-ray and head ultrasound equipment, with the services of appropriate support staff, shall be available to the neonatal units.CT Scan and MRILevel I, Level II A, Level II B OPTIONAL Level III A, Level III B, Level III C Computerized tomography (CT) and Magnetic resonance imaging (MRI) capability, with the services of appropriate support staff, shall be available on campus.Interventional Radiology ServiceLevel I, Level II A, Level II B NA Level IIIA, Level III B OPTIONALLevel III C The hospital shall have equipment for performing interventional radiology services.Neonatal EchocariographyLevel I, Level II A, Level II B OPTIONALLevel III A, Level III B, Level III C Neonatal echocardiography equipment and experienced technician shall be available on campus as needed with interpretation by pediatric cardiologist.Pediatric Cardiac Catheterization LaboratoryLevel I, Level II A, Level II B NALevel III A, Level III B OPTIONALLevel III C The hospital shall have a pediatric cardiac catheterization laboratory and appropriate staff.MaternalRadiology SupportLevel I - Optimal but not expected to have interventional radiologyLevel II A - - Optimal but not expected to have interventional radiologyLevel II B - -Optimal but not expected to have interventional radiologyLevel III A Interventional radiology optimalLevel III B -Interventional RadiologyLevel III C -Interventional RadiologyEQUIPMENTNeonatalEquipment and SuppliesAll Levels The hospital shall have all of the following equipment and supplies immediately available for existing patients and for the next potential patient: O2 analyzer, stethoscope, intravenous infusion pumps Radiant heated bed in delivery room and available in the neonatal units Oxygen hood with humidity Bag and masks capable of delivering a controlled concentration of oxygen to the infant Orotracheal tubes Aspiration equipment Laryngoscope Umbilical vessel catheters and insertion tray Cardiac monitor Pulse oximeter Phototherapy unit Doppler blood pressure for neonates Cardioversion/defibrillation capability for mothers and neonates Resuscitation equipment for mothers and neonates Individual oxygen, air, and suction outlets for mothers and neonates Emergency call system Equipment for the Neonatal Follow-up ClinicInfant Scale Stand-up scale Length board Stadiometer Oto-ophthalmoscope Sphygmomanometer Equipment for Hearing Assessment Exam rooms appropriate for examining children 0-3 years old. Neurodevelopment Assessment Kits Intensive Care Bed Physical facilities meet the requirements of the most current version of the Guidelines for Perinatal Care (6Th edition, chapter 2).Level I, Level II A NALevel II B OPTIONALLevel III A, Level III B, Level III C The hospital shall have a neonatal intensive care unit bed set up and equipment available at all times for an emergency admission.Laser Coagulation for Treatment of Retinopathy of Prematurity Level I, Level II A, Level II B NA Level III A OPTIONALLevel III B, Level III C The hospital shall have laser coagulation capability for retinopathy of prematurity or at closely related institution.Respiratory EquipmentAll Levels The hospital shall have appropriate equipment (including back-up equipment) for neonatal respiratory care as well as protocols for the use and maintenance of the equipment as required by its defined level status.Advanced Ventilatory Support Level I, Level II A, Level II B, Level III A NA Level III B, Level III C The hospital shall be capable of providing advanced ventilatory support for neonates of all birth weights.MEDICATIONSNeonatalEmergency MedicationsAll Levels Emergency medications, as listed in the Neonatal Resuscitation Program of the American Academy of Pediatrics/American Heart Association (AAP/AHA), shall be present in the delivery area and neonatal units.Emergent MedicationsLevel I, Level II A, Level III A The following medications shall be immediately available to the neonatal units: Antibiotics, anticonvulsants, and emergency cardiovascular drugs Level III A, Level III B, Level III C The following medications shall be immediately available to the neonatal units: Antibiotics, anticonvulsants, and emergency cardiovascular drugs Surfactant, prostaglandin E1EDUCATIONNeonatalCompetenciesAll Levels The hospital shall have identified minimum competencies for perinatal clinical staff, not otherwise credentialed, that are assessed prior to independent practice and on a regular basis thereafter. Education for PhysiciansAll Levels The hospital shall provide continuing education programs for physicians, nurses, and allied health personnel on staff concerning the treatment and care of obstetrical and neonatal patients. Education for Referring Hospitals/Providers Level I, Level II A, Level II B NA Level III A, Level III B, Level III C A hospital that accepts maternal or neonatal primary transports shall provide the following to the referring hospital/providers: Guidance on indications for consultation and referral of patients at high risk Information about the accepting hospitals response times and clinical capabilities Information about alternative sources for specialized care not provided by the accepting hospital Guidance on the pre-transport stabilization of patients Feedback on the pre-transport care of patients Education for PediatricsThe NICU Follow-up Clinic shall provide for continuing education programs for physicians, psychologists, nurses and other allied health professionals on the follow-up of the NICU graduate. MATERNALCompetenciesAll Levels The hospital shall have identified minimum competencies for the obstetric clinical staff, not otherwise credentialed, that are assessed on a regular basis thereafter (ie fetal monitoring interpretation, management of obstetric emergencies)Education for PhysiciansAll Levels The hospital shall provide continuing education programs for physicians, nurses, and allied health personnel on staff concerning the care of obstetric patientsEducation for Referring Hospitals or ProvidersLevel I, Level II A N/ALevel II B, Level III A, Level III B, Level III C A hospital that accepts maternal transports needs to provide to the referring hospital or health care provider the following: Guidance on indications for consultation Information about the accepting hospital regarding how to proceed with a transfer Information about alternative locations for referral in the circumstance where a transport cannot be taken (this should be an unusual occurrence) Guidance on the pre-transport stabilization of the maternal condition Feedback on the pre-transport care Information regarding the outcome and condition of the patient at discharge Information regarding care after dischargePERFORMANCE IMPROVEMENTNeonatalContinuous Quality Improvement (CQI)In Hospital Data collection, storage and retrieval. Identifying processes in need of improvement (see page 38, Perinatal care 6th edition). The hospital shall have a multi-disciplinary continuous quality improvement program for improving maternal and neonatal health outcomes that includes initiatives to promote patient safety including safe medication practices, Universal Protocol to prevent surgical error, and educational programs to improve communication and teamwork. Vermont Oxford Network quality improvement could be one of the resources for CQI. NICU Follow-up Clinic 1. Data collection, storage and retrieval. 2. Identifying processes in need of improvement. Case ReviewAll Levels The hospital shall conduct internal perinatal case reviews, which include all neonatal deaths, as well as all neonatal transports.Performance ReviewIn Hospital The hospital shall utilize a multidisciplinary forum to conduct quarterly performance reviews of perinatal program. This review shall include a review of trends, all deaths, all transfers, all very low birth weight infants, problem identification and solution, issues identified from the quality management process, and systems issues. NICU Follow-up Clinic An annual meeting with all Michigan NICU Follow-up Clinics to review clinic processes, data collection and outcomes. Health Department and Infant Mortality ReviewAll Levels The hospital shall participate with the Michigan health department Fetal and Infant Mortality Review programs. Improving Michigan Perinatal Health Outcomes All Levels The hospital shall participate in the collaborative collection and assessment of data with the Michigan Department of Health Systems for the purpose of improving perinatal health outcomes. MATERNALContinuous Quality ImprovementAll Levels Data collection, storage, and retrieval Identifying processes in need of improvement The hospital shall have a multi-disciplinary continuous quality improvement program for improving maternal health care and promote patient safety including safe medication practices, protocols to prevent surgical error, and education programs promoting teamwork and communication Measures for monitoring outcomesAll Levels Quality Performance Measures for Monitoring of Outcomes should also incorporate the knowledge that the largest impact on maternal and fetal outcomes may relate to access to prenatal care, preterm birth rates, and delivery of preterm gestations in a facility able to provide appropriate intensive neonatal care. Specific indices: Delivery Volumes Gestational age and birthweight range at delivery and number outside the Defined Level B-methasone administration prior to delivery in <34 weeks intact membranes and <32 weeks ruptured membranes GBS prophylaxis Unexpected transfers of neonate to higher level facility after delivery Use of 17-OH progesterone prophylaxis in patients with history of prior non-iatrogenic (spontaneous) preterm singleton birth Fetal Trauma/Birth trauma Elective delivery via induction or cesarean section prior to 39 weeks gestation Prenatal care (gestational age at onset) POLICIES AND PROTOCOLSNeonatalWritten PoliciesAll Levels The hospital shall have written policies and protocols for: The initial stabilization and continuing care of all neonatal patients appropriate to the level of care rendered at its facility. The hospital shall have neonatal resuscitation protocols. The hospital medical staff credentialing process shall include documentation of competency to perform neonatal invasive procedures appropriate to its designated level of care. The hospital shall have written guidelines for accepting or transferring neonates as back transports including criteria for accepting the patient and patient information on the required care. The hospital shall have a licensed neonatal transport service or written agreement with a licensed neonatal transport service. The hospital shall have policies that allow families (including siblings) to be together in the hospital following the birth of an infant and that promote parental involvement in the care of the neonate including the neonate in the NICU. MATERNALWritten PoliciesAll Levels The hospital will have written policies and protocols for: The initial stabilization and continuing care of all obstetric patients appropriate to the level of care rendered at its facility The hospital shall have protocols for treatment of common obstetric conditions including medication use for oxytocin, Magnesium sulfate, cytotec, The hospital medical staff credentialing process shall include documentation of competency to perform common obstetric procedures (including spontaneous vaginal delivery, operative vaginal delivery, breech delivery, cesarean section) dependent on the level of privileges granted and management of high risk obstetric patients The hospital shall have written guidelines for accepting or transferring obstetric patients The hospital shall have a transport service or agreement on method of transportation of appropriate patients The hospital shall have policies that allow families to be together for the birthing process unless emergent circumstances prevent Board Certified A board certified physician has taken and passed a medical specialty examination and is certified by an American Board of Medical Specialties Member BoardBack transferThe return of previously critically ill neonates from Level III NICUs to Level II and Level I nurseries for immediate and/or convalescing care (Jung, A.L. & Bose, C. L., 1983)Case managerHealth care professionals who concurrently plan for transitions of care, discharge and post-discharge follow-up; coordinate the services associated with discharge or return home; provide patient education; provide post-care follow-up; and coordinate services with other health care providers. Developmental PediatricianA physician who has completed a U.S. neurodevelopmental or developmental behavioral fellowshipEarly Intervention An array of early childhood services provided in response to a diagnosis or an identified developmental concern/need which are designed to meet the developmental needs of each child and the needs of the family related to supporting and enhancing the childs development (does not include routine medical services such as immunizations and well-child care).Early On ProgramState program established under Part C of the federal Individuals with Disabilities Education Act (IDEA). Early Onis a statewide, comprehensive, coordinated interagency system that provides and coordiantes early intervention services for infants and toddlers birth to age three years with disabilities and their families.Family PractitionerA physician who is residency trained in family medicine, which includes training in internal medicine, pediatrics and obstetricsImmediately availableA resource available as soon as it is requestedIn-house Physically present in the hospitalInternational Board Certified Lactation Consultant (IBCLC) A health care professional who specializes in the clinical management of breastfeeding. IBCLCs are certified by the International Board of Lactation Consultant Examiners (www.iblce.org) under the direction of the U.S. National Commission for Certifying Agencies. IBCLCs work in a wide variety of health care settings, including hospitals, pediatric offices, public health clinics, and private practice.Maternal Fetal MedicineMedical specialty with advanced training in high risk pregnancies.Medical Home The Patient Centered Medical Home (PCMH) is an approach to providing comprehensive primary care for children, youth and adults. The PCMH is a health care setting that facilitates partnerships between individual patients, and their personal physicians, and when appropriate, the patients family.Memorandum of Understanding (MOU)A legal document outlining the terms and details of an agreement between parties, including each parties requirements and responsibilitiesNeonatal FellowA physician who is completing a fellowship in neonatologyNeonatal Intensive Care Unit (NICU) Graduate Any infant who has spent more than 48 hours in a neonatal intensive care unitNeonatal Intensive Care Follow-up ClinicA clinic established to monitor NICU graduates who meet specific criteria for being at risk or having developmental delays. The clinic is staffed by personnel trained in evaluating the growth and development of high risk infants Neonatal Nurse PractitionerA registered nurse with an active license authorized to practice in the expanded role by the Michigan Board of Registration in Nursing and certified as a neonatal nurse practitioner by a nationally recognized accrediting body approved by the Board for nurse practitionersNeonateAn infant aged one month or less NeonatologistA physician who has satisfactorily completed a U.S. Neonatology fellowship program with hospital credentials in neonatology/newborn medicinePediatric subspecialistPediatrician certified in a recognized pediatric subspecialty (e.g., pediatric pulmonologist, pediatric cardiology, pediatric nephrology)PediatricianA physician either certified or eligible for certification by the American Board of Pediatrics Physician's Assistant (PA)A health care professional licensed to practice medicine with physician supervisionProgrammatic responsibilityThe writing, review and maintenance of practice guidelines; policies and procedures; development of operating budget (in collaboration with hospital administration and other program directors); evaluation and guiding of the purchase of equipment; planning, development and coordinating of educational programs (in-hospital and/or outreach as applicable); participation in the evaluation of perinatal care; and participation in perinatal quality improvement and patient safety activities.Readily availableA resource available for use a short time after it is requestedThirty minute accessAccess to a hospital within thirty (30) minutes under normal driving conditions which include, but are not limited to, weather, traffic, and other circumstances that may be beyond the individuals control Appendix C: REFERENCES American Academy of Pediatrics (2008). 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0]0gdw>0]0gd'r00]0^`0gd'rͼxg`XTXTXTXTJDJD@Jh{~ h{~0Jjh{~0JUhCZjhCZU hdhe jh&ChCZ<CJUaJ jh&ChCZ<CJUaJ j}h&ChCZ<CJUaJ jh&ChCZ<CJUaJ jYh&ChCZ<CJUaJ jh&ChCZ<CJUaJ j'h&ChCZ<CJUaJ jh&ChCZ<CJUaJ jh&ChCZ<CJUaJ|||||||||||W|j||||||| }}}}}M}`}~wl]h~|5CJOJQJ^JaJh~|5OJQJ^J hjh}7n&hnhj5CJH*OJQJ^JaJ&hPxhj56CJOJQJ^JaJhj5CJOJQJ^JaJhj5OJQJ^Jh+WO hz]h h0Jjh0JUh{~hjUh|0JmHnHujh{~0JU h{~0JMarch 31, 2009 PAGE 1 ATTACHMENT A MICHIGAN PERINATAL LEVEL OF CARE GUIDELINES (Based on AAP/ACOG Guidelines for Perinatal Care, 6th Edition; AAP Policy Statement Hospital Discharge of the High-risk Neonate, 2008; and AAP Follow-up Care of High-risk Infants, 2004) ATTACHMENT A MICHIGAN PERINATAL LEVEL OF CARE GUIDELINES (Based on AAP/ACOG Guidelines for Perinatal Care, 6th Edition; AAP Policy Statement Hospital Discharge of the High-risk Neonate, 2008; and AAP Follow-up Care of High-risk Infants, 2004) PAGE 48 March 31, 2009 Appendix B: DEFINITIONS |||*|W|}}} }M}~~~#~$~%~&~@~A~B~C~gdz]$a$gd+$gd>O 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