Karen Fugate University of Central Florida April 15, 2014 Initiation of a Pasteurized Donor Human Milk Program in a Large Safety-net Level III Neonatal ICU Karen Fugate University of Central Florida April 15, 2014 4/16/2014 klf

Significance of Problem Necrotizing enterocolitis (NEC) occurs in 11% of infants with a birth weight of <1500gms (Sharma & Hudak, 2013) Morbidity & Mortality (Bradshaw, 2009) 30% require surgery 25% with long term sequelae 50% mortality Incidence of NEC can be decreased with an exclusive human milk diet (Sharma & Hudak, 2013; AAP, 2012) 4/16/2014 klf

Significance of Problem (cont.) Mother’s own milk (MOM) offers the most protection (Sharma & Hudak, 2013; AAP, 2012) Many times MOM is unavailable Mother chooses not to provide expressed breast milk MOM is contraindicated (i.e. HIV, illicit drug use) MOM supply is insufficient Pasteurized donor milk (PDM) is a safe alternative and should be used when MOM is not available (Arslanoglu, Moro, & Ziegler, 2010; AAP, 2012) 4/16/2014 klf

% NEC in <1500 gm infants in our NICU compared to Vermont Oxford Network (VON) % <1500 gm infants d/c to home with any MOM Although decreasing, NEC rate in our NICU (6.7% or 10 cases, 2012) was still above VON mean (4.9%) This is an important baseline measure Didn’t want MOM to decrease with increase use of donor milk Baseline Data 4/16/2014 klf

Potential Strategies convene a taskforce of key stakeholders formulate guidelines for the use of PDM develop parental consent forms and education Contain costs ($3.50- $4.50/oz versus free formula) Get staff buy-in Kamholtz, Parker, and Phillip, 2012; Rosenbaum, 2012 4/16/2014 klf

Change Management Strategies Approval from NICU Nurse Manager and NICU Medical Director Senior leadership approval not required NICU NM felt cost of PDM could be absorbed in NICU budget Existing NICU Best Practice Committee would be driving force behind change Physicians (attendings and fellows) Nurse practitioners Nursing Dietician Lactation Facilitator – NICU Quality Specialist Suggest NICU Fellow use this as QI mandatory QI project 4/16/2014 klf

Plan Design Overview: Steps in place prior to implementation Purchase contract with milk bank already in place for PDM Parental consent form already in place 4/16/2014 klf

Plan Design Overview: Next steps Start Sept 2012 PDM Guidelines – Nov 2012 Parental education information – Nov 2012 Process to maintain PAR level and minimize waste of PDM – Dec 2012 Staff education – Dec 2012 Go live 1/1/2013 1st PDSA cycle evaluated 1/31/13 1st outcome (NEC) 4/16/2014 klf

Plan Design: PDM Guidelines Population: <1500gm infants Offer PDM when MOM not available Wean off PDM at 32 weeks post conceptual age Obtain consent before mother d/c from postpartum – ensures consented infants do not receive any formula 4/16/2014 klf

Plan Design: Consent Process and Parent Education “consent process” adopted by NICU Fellow as QI project Consent obtained Obtained prior to mother’s discharge FAQ developed FAQ provided Perceived usefulness of FAQ 4/16/2014 klf

Plan Design: PDM order and distribution process PAR level created and maintained Dietician collaborates with PCT daily to determine total volume of PDM needed PCT thaws total volume of PDM, divides into individual aliquots, labels, and delivers to patient room 4/16/2014 klf

Plan Design: Staff education Educated on guidelines, distribution process, rationale for exclusive human milk diet Questions encouraged Fears dispelled with evidence-based articles and information on strict QI process used at HMBANA milk banks to ensure safety of PDM 4/16/2014 klf

Cost and Potential Savings Cost of PDM Additional PDM = $8000 PCT wages = $5800 Total = $13,800 Estimated savings from prevented cases of NEC 50% reduction = 5 cases Estimate cost/case = $74,004 Total savings = $370,020 Potential cost savings = $356,140 ($370,020 - $13,800) 4/16/2014 klf

Process Measures 1. Process measures related to consent process; Data source: NICU Fellow Quality Project FAQ Usefulness rated on 5 point Likert scale – 4.5-4.8. Deemed useful . 3. Reliability of PDM process measured by number of times PDM was not available = “0”. Deemed reliable. 4/16/2014 klf

Outcome Measures Minus 10 cases (100% reduction) 2012-2103; < VON mean 1. Reduction of NEC with introduction of PDM program; Data source: VON 2. Estimated cost savings for one year with introduction of PDM program 4/16/2014 klf

Balancing Measure Percent of <1500 gm infants with any MOM at discharge to home (Data source: VON) and percent of <1500 gm infants receiving any PDM during NICU stay (Data source: chart audit) Indicates that implementation of the PDM project did not negatively effect the percent of preterm infants receiving the benefit of their mother’s breast milk at discharge. 4/16/2014 klf

References Bradshaw, W. T. (2009). Necrotizing enterocolitis: Etiology, presentation, management, and outcomes. The Journal of Perinatal and Neonatal Nursing, 23(1), 87-94. doi: 10.1097/JPN.0b013e318196fefb Kamholtz, K. L., Parker, M. G., & Phillip, B. L. (2012). Implementing change: Steps to initiate a human donor milk program in a US Level III NICU. Journal of Human Lactation, 28(2), 128-131. doi: 10.1177/0890334412438962 Rosenbaum, K. (2012). Implementing the use of donor milk in the hospital setting: Implications for nurses. Nursing for Women’s Health, 16(3), 202-208. doi: 10.1111/j.1751-486X.2012.01731.x Sharma, R., & Hudak, M. L. (2013). A clinical perspective of necrotizing enterocolitis: past, present, and future. Clinics in Perinatology, 40(1), 27-51. doi:10.1016/j.clp.2012.12.012 4/16/2014 klf