1. 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

2. 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

3. 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

4. % 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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, $13,800)
4/16/2014
klf

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

15. Outcome Measures
Minus 10 cases (100% reduction) ; < 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

16. 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

17. References
Bradshaw, W. T. (2009). Necrotizing enterocolitis: Etiology, presentation, management, and outcomes. The Journal of Perinatal and Neonatal Nursing, 23(1), doi: /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), doi: /
Rosenbaum, K. (2012). Implementing the use of donor milk in the hospital setting: Implications for nurses. Nursing for Women’s Health, 16(3), doi: /j X x
Sharma, R., & Hudak, M. L. (2013). A clinical perspective of necrotizing enterocolitis: past, present, and future. Clinics in Perinatology, 40(1), doi: /j.clp
4/16/2014
klf