The deadline for submitting an application is September 6, 2018.

July 2, 2018 Dear Florida Hospital Leaders, It s with great enthusiasm we invite you to participate in the Florida Perinatal Quality Collaborative (FPQC) initiative for Neonatal Abstinence Syndrome (NAS) designed to assist neonatal and maternal health care stakeholders develop and implement quality improvement strategies aimed at improving standardization of care and decrease hospital length of stay for NAS infants. The U.S. is experiencing an opioid epidemic; Florida has experienced a 10-fold increase in NAS rates from 2002-2012. In fact, it is estimated that one NAS infant is born every 25 minutes. A recent FPQC survey of NICUs revealed wide variability in length of hospital stay and a lack of standardized processes to manage NAS infants. Both of these findings indicate there is opportunity to improve the hospital management of NAS infants in Florida. FPQC invites you to apply to be part of our NAS initiative. Through FPQC s Vision, All of Florida s mothers and infants will have the best health outcomes possible through receiving high quality evidence-based perinatal care, we are proud to partner with expert perinatal health-related practitioners, representing a variety of professionals and specialties, statewide agencies and national organizations, including advocacy groups, educators, and policymakers to collaboratively support you and your hospital team to implement the best evidenced-based approaches for your mothers and babies. A variety of resources will be provided at no cost to support interested hospital teams in your efforts, including a hospital toolkit, evidence-based clinical recommendations from the FPQC s interdisciplinary advisory group, grand rounds and technical assistance from an expert in the field, online training webinars and collaborative calls, and secure data tracking with monthly quality improvement data reports. To assist hospitals in learning more about the initiative and the application process, we will hold an informational webinar on July 25, 2018 at 12 pm ET. An application guide for the NAS Initiative is included with this letter. To apply for the NAS Initiative, please complete the online application at this link: https://tinyurl.com/nasapplication. The deadline for submitting an application is September 6, 2018. We are happy to offer technical support during the application process; please email FPQC@health.usf.edu if you have questions. Upon review of hospital applications, FPQC will reach out to applicant team leaders and champions to confirm commitment. FPQC will hold an in-person NAS Initiative orientation kick-off meeting for teams from participating hospitals on Wednesday November 8, 2018 in Orlando. Participating hospitals will be required to attend, so make sure your hospital s team marks their calendars. We hope your hospital will consider applying to participate in this QI initiative aimed at helping you and your hospital to improve the care of NAS infants in Florida. Thank you so much for your consideration. Sincerely, William M. Sappenfield, MD, MPH Director, Florida Perinatal Quality Collaborative The Chiles Center for Healthy Mothers and Babies University of South Florida College of Public Health 3111 East Fletcher Avenue Tampa, FL 33613-4660 PHONE: (813) 974-8888 FAX: (813) 974-8889 EMAIL: fpqc@health.usf.edu FPQC.org

NEONATAL ABSTINENCE SYNDROME (NAS) INITIATIVE APPLICATION GUIDE TABLE OF CONTENTS This application guide explains the objectives of the Neonatal Abstinence Syndrome Initiative, reviews our model for quality improvement, your role as a participant, the project timeline and activities, and proposed project measures. Project Overview... 3 Project Goal... 3 Why Join the Initiative... 3 Hospital Collaborative Initiative... 4 NAS Initiative Timeline... 5 NAS Recommended Key Practices... 6 Initiative Core Measures... 7 How to Apply... 7 APPENDIX A: KEY DRIVER DIAGRAM... 8 APPENDIX B: MEASUREMENT GRID... 9 Page 2 v. 7/2018

Project Overview The United States is battling an opioid epidemic, which has resulted in increasing illicit use and misuse of prescription opioids among pregnant women. Neonatal abstinence syndrome (NAS), in which infants exhibit postnatal withdrawal symptoms most commonly due to chronic in utero exposure to opioids, is one unfortunate sequelae of the opioid epidemic. It manifests as a combination of central nervous system irritability, autonomic nervous system hyperactivity, respiratory difficulties, and gastrointestinal dysfunction. The majority of pregnant women taking illicit drugs, using prescribed opioids, or receiving opioid replacement therapy will deliver an infant having withdrawal symptoms, and many of these infants will develop NAS and require pharmacologic management. NAS infants are more likely to have a diagnosis of prematurity, low birth weight, respiratory complications, seizures, and feeding difficulty. Beyond the neonatal period, they are at risk for behavioral problems, learning problems, visual disorders, and psychosocial difficulties (for example, risk for child abuse, foster placement). Despite awareness of a rising NAS incidence, there is a scarcity of evidence-based management for NAS, lack of improvement in length of inpatient stay, and a rise in health care costs, which highlight the considerable variations in its management by pediatricians and neonatologists. The FPQC hopes to address variability in NAS management. Project Foci Standardization related to: Prenatal care Parent engagement NAS diagnosis Infant nutrition Non-pharmacologic strategies Pharmacologic management Safe discharge care plans Project Goal Our aim is that by 6/2020, FPQC participating hospitals will have a 20% decrease in baseline length of stay for all term infants with a diagnosis of NAS, regardless of inpatient location in the hospital. Why Join the Initiative The NAS Initiative offers an opportunity for your facility to implement change and improve the care provided to infants diagnosed with NAS. The goal of the NAS Initiative is to apply evidence-based interventions to improve care for NAS infants in Florida hospitals. The FPQC aims to support collaborating hospitals as they develop and implement multi-disciplinary teams and strategies with the ultimate goal of reducing length of stay for NAS infants. Stakeholders across the state and the U.S. have begun to take note of NAS rates. The number of neonates with NAS admitted to the NICU increased by 10-fold from 2005 to 2011. Increases in the incidence of NAS have been reported uniformly across community hospitals, teaching hospitals, and children s hospitals. All communities and all ethnicities have been affected. The rise in NAS has resulted in increased healthcare costs particularly in the Medicaid population... Joining the initiative helps your hospital work in a collaborative with resources to help you implement evidence-based quality improvement recommendations. It also offers an environment to learn together with others on the best strategies, methods and tools to adapt and implement in your hospital. Hospitals that participate in multi-organization quality improvement collaboratives achieve more gains faster than those who do so alone. Past Page 3 v. 7/2018

participants have found it useful to not have to reinvent the wheel. Participation in a multi-hospital collaborative is shown to result in more rapid positive change in patient safety. Read on to learn what kind of support the FPQC can provide participating hospitals and what hospitals will be asked to commit in order to participate. If you have any questions about the information presented here, please email FPQC@health.usf.edu. Hospital Collaborative Initiative We plan to achieve improvements in the care of NAS infants by implementing best practice guidelines as developed by the Florida NAS Advisory Work Group. Participating hospitals will start the initiative together in November 2018, launch their projects in their local facilities in January 2019, and agree to tailor and implement all hospital identified process improvements over the next 18 months. FPQC will: Build a strong collaborative learning environment to support hospitals with driving change Coordinate experts and other resources to support the improvement process Offer content oversight and process management for the initiative Offer participants with evidence-based information on the subject and information on application of that subject matter via medical and quality improvement experts Offer tools and resources to support hospitals in implementing process changes and improving documentation Develop/adapt/update useful materials and tools as needed by the initiative Host an online resource toolbox for hospital implementation Offer guidance and feedback to participating hospitals on executing improvement strategies Provide educational events and conduct on-site technical assistance consultations Convene monthly learning session webinars to support hospitals in driving change Facilitate an online data submission process and monthly quality improvement data reports for participating hospitals as well as a baseline assessment report Communicate progress and deliverables to the stakeholders of FPQC Evaluate and report results in a fashion that does not publicly identify hospitals and providers In 18 months, participating facilities will implement strategies until core components are implemented, then spend at least 6 additional months institutionalizing the strategies. We expect participating hospitals and providers to make a commitment to implementing change and reporting your progress during the collaborative for the benefit of all neonatal services statewide. Participating Collaborative Hospitals are required to: Assemble a strong QI and fully-committed team including physician, nurse and administrative champions and conduct regular team meetings to track progress throughout the initiative. Complete FPQC pre and post implementation surveys. Commit at least one team member to attend every NAS learning series webinar. Schedule an onsite educational and technical assistance visit from FPQC advisors. Page 4 v. 7/2018

Develop, add or amend hospital or department policy to reflect recommended quality processes and procedure changes. Sign Data Use Agreement and document, submit, track, and report all required FPQC process and outcome measures on a monthly basis throughout the initiative. Notify FPQC of changes to the QI team. Send at least two members of your team to participate in the November 8, 2018 Kick-Off meeting in Orlando and attend a second Initiative face-to-face training meeting in 2019. Participate in presentation on one of the monthly learning webinars on sharing progress, overcoming challenges, seeking consultation, or other topics. Hospital Administrator in Participating Hospitals: Promote the goals of the collaborative and develop links to hospital strategic initiatives. Provide the resources to support their team, including time to devote to this effort (team meetings, learning sessions, FPQC NAS in-person meetings and monthly webinars) and facilitate active senior leadership involvement as appropriate. Closely track initiative progress to assure adequate initiative support during the project duration. Hospital MD and Nurse Leaders in Participating Hospitals: Lead the hospital s quality improvement efforts, including convening regular team meetings. Develop a strategy for accountability among partners to help assure progress toward local goals. Attend NAS initiative in-person meetings and monthly collaborative webinars. Share information and experiences from the initiative with fellow participants on conference calls/webinars and at in-person meetings. Perform tests of change that lead to process improvements in the organization. Work with your peers to gain support and corporate initiative components into practice. Spread successes across the entire hospital system where applicable. Strategies will be adaptable to all hospital settings. Each facility can either adopt an existing set of protocols or guidelines and tools or develop/adapt protocols or guidelines and tools using the evidence-based elements. NAS hospitals will learn improvement strategies that include establishing goals and methods to develop, test, and implement changes to their systems. Quantitative and qualitative data will be collected by sites, submitted to FPQC monthly via a HIPAA-compliant, secure online interface, and shared regularly with hospital teams in a de-identified fashion. A data use agreement will be provided to accepted hospitals. NAS Initiative Timeline Timeline is subject to change. Tasks Recruit Leadership Team and Submit Hospital Application to Participate Target Completion Date August 2018 Accepted Hospital Commitment Agreements Submitted September 2018 Prepare for Hospital Kick Off, Establish Local Team Meeting Schedule, Collect and Submit Baseline Data October December 2018 Page 5 v. 7/2018

In-person NAS Kick-Off Meeting Training, Complete Pre- Implementation Survey November 8, 2018 Individual Hospital Kick-Offs of NAS Initiative January 2018 Regular Learning Session Webinars for training and collaboration (including at least one presentation from each facility on your progress). Hold regular local team/department meetings. December 2018 June 2020 On-Site Technical Assistance Consultations from FPQC January 2019 March 2020 Ongoing Data Collection and Technical Assistance upon request January 2019 May 2020 Mid-Project In-person Meeting Fall 2019 Hospital Post-Implementation Survey May 2020 Initiative Completion June 2020 NAS Recommended Key Practices I. Form a multi-disciplinary team to address NAS II. Encourage parent/caregiver engagement III. Develop a hospital guideline to manage opioid use disorder and NAS IV. Monitor infant nutrition V. Screen mothers for substance use VI. Identify infants at risk for developing NAS VII. Use an abstinence scoring system VIII. Optimize non-pharmacologic management IX. Provide pharmacologic management when necessary X. Be compliant with a safe discharge care plan for every NAS infant A key driver diagram that visualizes factors that impact outcomes in order to assist in prioritizing strategies and actions to improve outcomes is included in Appendix A. Page 6 v. 7/2018

Initiative Core Measures Data is a key component of quality improvement; what gets measured gets managed! Participants will focus on improving practice metrics for their institution relative to their baseline measures (aggregate and de-identified data provided by participating sites). Metrics will be made available for all sites in a de-identified fashion for ready comparison across institutions. Participating hospitals will be asked to collect and submit data to support outcome, process, and balancing measures. Please see the Measurement Grid in Appendix B for more information on each measure. How to Apply To be involved in NAS Initiative, please complete the online application at this link: https://tinyurl.com/nasapplication. The deadline for submitting an application is September 6, 2018. It is important that you coordinate with your entire department to ensure everyone is aware that you are submitting an application and your hospital does not submit more than one application with different champions. A minimum of 3 team leaders are required. We will contact all team members by email to confirm commitment; a response from all team members will be required to complete your application. If accepted, a Hospital Commitment Letter signed by an appropriate authorizing hospital executive will be required. A Data Use Agreement will be provided to accepted hospitals. Page 7 v. 7/2018

APPENDIX A: KEY DRIVER DIAGRAM A key driver diagram is intended to assist in identifying factors that impact outcomes, and in prioritizing actions and strategies to be undertaken to improve outcomes. Neonatal Abstinence Syndrome Initiative Page 8 v. 7/2018

APPENDIX B: MEASUREMENT GRID These measures will be calculated and reported to the hospitals in a quality improvement data report so that facilities can track their progress. *NOTE: These measures are subject to change during the process of finalizing data collection and reporting tools.* Definition of NAS (Inclusion Criteria): Any infant 37 0/7 weeks gestational age admitted in any inpatient hospital location with clinical signs of withdrawal not explained by another etiology (e.g., sepsis, intracranial hemorrhage, hypocalcemia, non-opioid drug/substance) AND the severity of their withdrawal signs requires treatment. Treatment for withdrawal includes initial hospitalization >3 days for palliative non-pharmacologic care and/or pharmacologic treatment. Definition of NAS (Exclusion Criteria): Exclude the following: 1) infants readmitted for management of NAS symptoms; 2) infants being monitored for withdrawal without clinical signs of NAS; 3) infants with iatrogenic withdrawal (ICD-10 code P96.2) defined as neonates who require opioids to prevent or treat signs of withdrawal following prolonged use of opioids for valid medical conditions (e.g., extracorporeal life support, or treatment of pain after surgical procedures); and, 4) infants who do not develop any clinical signs of withdrawal OR who are not treated for withdrawal with either non-pharmacologic or pharmacologic measures regardless of maternal history of opioid use and positive maternal/infant laboratory testing. # Outcome Measure Description Frequency 1 Length of Stay Numerator: Total # of days of each infant's duration of hospitalization (i.e., date of initial disposition - date of birth) diagnosis of NAS # Process Measures Description Frequency 1 Some process measures will be reported on individual infants, and some will be reported on individual hospitals. Bundle includes: 1) trauma-informed care, 2) psychology of addiction, 3) motivational interviewing, and 4) NAS symptoms, scoring, and non-pharmacologic techniques. NAS education bundle compliance for staff and providers. Numerator: # of nurses, advance practice nurses (ARNPs, PAs), and physicians who received education on EACH topic of the NAS education bundle to date Denominator: Total # of nurses, advanced practice nurses (ANRPs, PAs) and physicians who care for NAS infants to date Exclusion: Obstetric providers Quarterly (cumulative % for EACH individual topic) Page 9 v. 7/2018

2 3 4 Primary caregiver perception of engagement during infant's hospitalization *provisional measure pending successful testing Inter-rater reliability with scoring tool NAS education bundle compliance for infant s primary caregiver Average of Likert scale response from parent or primary caregiver for EACH survey question for all NAS infants at the time of initial disposition. Exclusion: Foster care placement, mother is incarcerated, adoption, mother in inpatient MAT or hospitalized for a medical reason. Numerator: # of current nurses who have demonstrated 90% inter-rater reliability with your institution's NAS scoring tool Denominator: Total # of current nurses caring for NAS infants to date Exclusions: institution defines "nurses" (i.e. include floats, core group of nurses that perform scoring, etc.). *Institution determines how to measure inter-rater reliability (FPQC will provide suggestions) Bundle includes all of the following: 1) safe sleep, 2) expectations of hospital stay, 3) shaken baby syndrome, 4) postpartum depression, 5) NAS symptoms, scoring, and nonpharmacologic techniques. (Only 1 parent or primary caregiver needs to receive education bundle per NAS infant) Numerator: # of primary caregivers that with documented completion of ALL topics of the NAS education bundle Quarterly Quarterly (Current %) diagnosis of NAS Exclusion: Foster care placement Rooming-in is defined as: parent or other caregiver visitation with infant for 6 hours/day. 5 Rooming-in frequency Numerator: # of hospital days where primary parent or caregiver spent 6 hours rooming-in with infant Denominator: Total # of hospital days for ALL infants 37 0/7 weeks GA admitted anywhere in the hospital with a diagnosis of NAS Exclusions: parent requires supervised visits, foster care placement, mother is incarcerated, adoption, mother in inpatient MAT or hospitalized for a medical reason. Page 10 v. 7/2018

Numerator: Total # of infants receiving any MOM (breastfeeding or EBM) within first 3 days of life 6 Any breast milk within first 3 days of life diagnosis of NAS where breastfeeding is not contraindicated Exclusion: Breastfeeding contraindicated, foster care placement, mother is incarcerated, adoption, mother in inpatient MAT Numerator: Total # of infants receiving any MOM (breastfeeding or EBM) on day of initial disposition 7 Breast milk at initial disposition diagnosis of NAS where breastfeeding is not contraindicated Exclusion: Breastfeeding contraindicated, foster care placement, mother is incarcerated, adoption, mother in inpatient MAT or hospitalized for a medical reason Numerator: # of infants who were started on your institution's 1st line medication when treatment threshold was met 8 Pharmacologic management (1st line medication): initiation diagnosis of NAS where the treatment threshold for medications was met 9 Pharmacologic management (1st line medication): recommended 1st dose Exclusions: already started on medications prior to transfer *Treatment threshold is defined by the individual institutions. Numerator: # of infants who were started on your institution's 1st line medication at the correct dose according to the institution s guideline. diagnosis of NAS and started on medication Exclusions: already started on medications prior to transfer, *Correct drug and dose is determined by individual institution. Page 11 v. 7/2018

Numerator: # of infants weaned per your institution's guideline from "capture" to medication discontinuation or initial disposition (whichever comes first) 10 Pharmacologic management (1st line medication): weaning diagnosis of NAS and started on medication 11 Pharmacologic management bundle Exclusions: initial disposition before medication weaning occurs *Weaning parameters are determined by individual institution. *"Capture" is defined as time from peak dose of medication to first wean. *To be included in the numerator, must be compliant with each weaning opportunity. Numerator: # of infants with compliance with your institution s guidelines including initiation (measure 8), 1st dose (measure 9), and weaning of 1st line medication (measure 10). diagnosis of NAS *calculated by FPQC Exclusions: initial disposition before medication weaning occurs Bundle includes all of the following: 1) DCF report filed for infants with confirmed NAS; 2) discharge clearance determined; 3) Education on safe sleep, shaken baby syndrome, postpartum depression, NAS signs (measure 4); 4) Early steps referral made prior to hospital discharge; 5) Healthy Start referral; 6) Pediatrician appointment made within 3 business days of infant discharge 12 Safe Discharge bundle compliance. Numerator: # of infants with documentation of all elements of the Safe Discharge bundle diagnosis of NAS Exclusions: infant discharged to a state outside of Florida *To be included in the numerator, must be compliant with ALL Safe Discharge bundle elements. # Balancing Measure Description Frequency 1 Outpatient medication management for NAS Numerator: # of NAS infants discharged home with any medication to manage NAS symptoms diagnosis of NAS and started on medication Quarterly Page 12 v. 7/2018