Running head: INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
Initiation of Donor Human Milk in the Neonatal Intensive Care Unit: A Performance
Improvement Project
Karen Fugate
University of Central Florida
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INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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Initiation of Donor Human Milk in the Neonatal Intensive Care Unit: A Performance
Improvement Project
Significance of Problem
Necrotizing enterocolitis (NEC) is one of the most common gastrointestinal disease
processes affecting infants in the neonatal intensive care unit (NICU). Its morbidity and mortality
are significant. Nearly a third of affected infants need surgery, up to twenty-five percent suffer
long-term sequelae, and surgical case mortality is nearly fifty percent (Bradshaw, 2009). More
than eighty-five percent of all NEC cases occur in very low birth weight infants (<1500 grams)
or in very premature infants born at less than thirty-two weeks gestational age (Sharma & Hudak,
2013). The prevalence of NEC varies among centers. Multicenter and large population-based
studies such as the National Institute of Child Health Neonatal Research Network (NICHDNRN) study from 2003 to 2007 report the prevalence of NEC as eleven percent among infants
born at twenty-two to twenty-eight weeks gestational age and with a birth weight 401–1500
grams (Sharma & Hudak, 2013). The Vermont Oxford Network (VON) is an international
database registry that provides benchmarking capabilities for participating NICUs related to
mortality and major morbidities (including NEC) seen in the neonatal population. The VON
reports the mean rate for NEC in 2012 to be 4.9% across the entire registry; the NEC rate for the
twenty participating Florida NICUs is 5.4% (Vermont Oxford Network [VON], 2014). The
specific etiology of NEC is unclear but is currently thought to be multifactorial (Bradshaw,
2009). Prevention would result in a substantial impact on neonatal morbidity and mortality as
well as a significant cost savings.
Mother’s own milk (MOM) has been determined to have a protective effect against NEC
(Sharma & Hudak, 2013; American Academy of Pediatrics [AAP], 2012) and should be
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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encouraged and supported; however many times the mother chooses not to provide expressed
breast milk or she is unable to produce a sufficient volume to meet the nutritional requirements
of her infant. When MOM is not available, it is recommended to provide pasteurized human
donor milk (PDM) to reduce the risk of NEC. Two recent systematic reviews have demonstrated
the protective effect of donor milk on the incidence of NEC (Arslanoglu, Moro, & Ziegler,
2010). Additionally, the AAP (2012) recommends an exclusive human milk diet for premature
infants including the use of PDM when MOM is not available.
One of the significant barriers to the use of donor milk in NICUs is cost. Neither PDM or
formula is reimbursed; it is included in the daily room charge. Parker et al. (2013) found that
most donor milk nonusers felt that donor milk was too expensive; this was found to be
particularly true in safety-net hospitals where Medicaid comprises greater than seventy-five
percent of the payer sources. Therefore, one must make a strong argument that the benefits of
pasteurized human donor milk, namely the reduction in NEC cases, outweigh the cost. This
performance improvement project will summarize the actual implementation of a multifaceted
program to provide an exclusive human milk diet with the addition of pasteurized donor milk in
a large Level III safety-net NICU.
Baseline Data
The incidence of NEC at the targeted NICU was ten cases in 150 infants with a birth
weight of less than 1500 grams or 6.7% in calendar year 2012. The incidence of NEC, although
improving, remained higher than the mean incidence of NEC in the VON registry for several
years (see Figure 1). In 2012, the use of PDM was reserved for those infants who demonstrated a
significant intolerance to premature infant formula despite repeated attempts to advance feeds.
Baseline usage of PDM was approximately 250 ounces annually based on purchase order data.
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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Another important baseline measure was the percent of infants discharged on MOM. A main
concern was that the use of MOM would decease once PDM became available. This would be an
untoward outcome as MOM has immunoprotective properties above and beyond PDM (Sharma
& Hudak, 2013). Additionally, the NICU had worked very hard to improve the percent of
preterm infants still receiving the benefits of MOM at discharge demonstrating improvement
Percent of infants with NEC
over several years (see Figure 2).
12
10
8
6
Target NICU
4
VON mean
2
0
2010
2011
2012
Birth Year
Figure 1: Percent of < 1500 gm infants with NEC at target NICU compared to VON mean;
Source: VON
60
Percent
50
40
30
2010
20
2011
10
2012
0
% <1500gm infants d/c to home with ANY MOM
Birth year
Figure 2: Percent < 1500 gm infants discharged to home with any mom's own milk (MOM);
Source: VON
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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Potential Strategies
There was little in the literature regarding potential strategies to implement the use of
PDM in a NICU. Kamholtz, Parker, and Phillip (2012), suggested the following: convene a
taskforce of key stakeholders, formulate guidelines for the use of PDM, develop parental consent
forms and education, and provide staff education. Guidelines for PDM use are critical to control
costs; most NICUs only offer PDM to the most high-risk populations. Rosenbaum (2012)
interviewed three NICUs that had implemented a PDM program and summarized key success
strategies to include: strong change agent, a multidisciplinary team, and incorporation of the
latest research and guidelines. She stressed the need to obtain PDM from a milk bank certified by
the Human Milk Bank Association of North America (HMBANA) to ensure safety (Rosenbaum,
2012). Rosenbaum (2012) reported significant barriers to be cost, difficulty gaining staff buy-in
and the logistical challenge of creating space for the safe preparation of PDM. Calculating
twenty –four hour need for PDM, thawing based on need, and dividing into aliquots for
individual infants should be considered to contain costs (Rosenbaum, 2012). When MOM is not
available, the alternative to PDM is preterm infant formula with an average cost of seventy to
eighty cents per ounce compared to $3.50 to $5.00 per ounce for PDM (Rosenbaum, 2012). In
2012, our hospital received free formula so there was no cost associated with preterm formula
use. Rosenbaum also stressed the importance of sage storage and preparation of PDM which
should be consistent with American Dietetic Association (ADA) guidelines for management of
human milk in health care facilities (Rosenbaum, 2012). Based on review of the literature,
several key strategies emerged: involve key stakeholders, develop guidelines for use, contain
costs, get staff buy-in, develop parent education and consent materials.
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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Culture and Change Management Strategies
Considering the expense and the scope of the practice change, NICU nursing and medical
leadership had to be on board. The concept of PDM had been discussed in the past at
multidisciplinary NICU Best Practice Committee meetings and the consensus decision was that
the evidence was not strong enough to warrant routine use of PDM for the preterm population.
The catalyst for change occurred in 2012 with the release of the AAP endorsement of an
exclusive human milk diet for preterm infants (AAP, 2012) and a NEC rate that continued to be
above the VON mean despite improvements in the provision of MOM (see Figure1&2). The
decision was made to proceed with a plan to introduce PDM in the NICU. The decision was
approved by the NICU Medical Director, the NICU Nurse Manager, lactation, NICU Dietician,
and the NICU Best Practice Committee. The NICU Best Practice Committee was the driving
factor behind this and many other evidence-based practice changes. Approval from senior
leadership was not required as the NICU Nurse Manager felt the NICU budget could absorb the
cost of the PDM. The project would be facilitated by the NICU Quality Specialist.
Plan Design
Since PDM was already being used in the NICU on a limited basis, a mechanism to
obtain PDM was already in place as well as a parental consent form. A comprehensive plan to
introduce PDM in the NICU was conceptualized to include development of the following: usage
guidelines for PDM, parental educational information, staff education, process to ensure a par
level of PDM was maintained, process to quantify total twenty-four hour volume of PDM , as
well as a process to prepare and distribute PDM to individual patients. A taskforce was created to
address the steps in the plan described in detail below. The project was overseen by the NICU
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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Best Practice Committee and facilitated by the NICU Quality Specialist. The project began in
September of 2012 with a goal of “go-live” January 1, 2013 (see Figure 3).
Sept 2012
Start
10/31/12
PDM guidelines
developed
11/30/12
12/15/12
FAQ, parental
survey developed
by NICU fellow
PDM ordering and
distribution
process finalized
1/1/13
Go-live
1/31/13
1st PDSAs
evaluated
3/31/13
1st outcome
evaluated (NEC
cases)
Figure 3: PDM project time line
PDM Guidelines
The taskforce developed guidelines that were approved by the NICU Best Practice
Committee. It was decided to routinely offer PDM to any <1500 gram infant where MOM was
not available either because of maternal choice, contraindication, or lack of sufficient volume.
MOM was always given if available. Infants were weaned off PDM at thirty-two weeks
corrected gestational age when the risk of NEC decreases considerably (Arslanoglu et al., 2010).
The guidelines described the parental consent process; consent was to be obtained by an RN or
the medical team prior to mom’s discharge from the hospital. This ensured that infants would not
receive formula while waiting to obtain consent. The consent process also involved providing the
parent with a Frequently Asked Questions (FAQ) handout discussed below. Compliance with the
PDM Guidelines was measured via PDSA methodology specifically evaluating if mother was
consented, if she was provided with the FAQ handout, and if she was consented prior to
discharge. This data was captured by a combination of chart audit (presence of consent and date
of consent relative to mom’s discharge) and maternal survey to verify she had received the FAQ
handout and the extent to which the mother found the FAQ to be useful. As a teaching facility,
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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the NICU has several neonatal fellows. Each fellow is required to complete a quality project
during their fellowship. We try to match the interests of the NICU fellows with the current needs
and projects in the NICU thereby making the best use of resources. One of the NICU fellows,
with guidance from the NICU Quality Specialist and NICU Medical Director, chose compliance
with the consent process as their quality project.
Parental Education – FAQ
The FAQ handout was developed by the NICU fellow mentioned above as part of their
mandatory quality project. The handout was developed in English and Spanish on a fifth grade
reading level. As mentioned above, the usefulness of the handout was evaluated by administering
a short survey to the mother regarding whether or not the handout provided useful information
on PDM and helped with the consent process. The survey had five questions on a 5 point Likert
scale. The survey was developed in English and Spanish. This was a voluntary paper and pencil
survey administered as part of a quality project so IRB approval and maternal consent was not
required.
Staff Education
Staff education on the benefits of PDM, rationale for an exclusive human milk diet for
the preterm infant, newly developed guidelines, and consent process was provided by the unit
based educator. Relative articles, guidelines, consent, and the FAQ handout were made available
on the NICU Portal (NICU intranet) so they could be readily accessed at the bedside. Feedback
and questions were encouraged and addressed to help overcome the cultural barrier voiced by
some staff who thought the concept of PDM was “gross”. Fears were dispelled with the
provision of evidence-based articles, education, and information on the strict screening,
pasteurization, and handling procedures of HMBANA milk banks. This was a key step in the
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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success of the project. Staff needed to project their belief that PDM was beneficial to the preterm
infant during the consent process.
PDM Ordering, Handling, and Distribution
It was essential that once offered to a parent, PDM was available. Therefore a par level
had to be created and maintained. A par level of thirty, three ounce bottles of PDM was agreed
upon. A system was developed whereby the NICU dieticians would provide the NICU Patient
Care Techs (PCT) with the names of infants in the NICU and the total volume of PDM every
Monday. The PCT orders the designated volume plus any additional required to maintain the par
level. The milk bank ships the ordered volume which is received the next business day via FedEx
on dry ice.
Given the cost of PDM, it was also essential to have an organized, efficient means to
distribute the PDM to individual infants to eliminate waste. Once thawed, PDM is refrigerated
and can only be used for twenty-four hours per ADA recommendations. Many infants twentyfour hour feed volume was significantly less than three ounces (the volume in one container of
frozen PDM). Therefore, if each infant was allotted one three ounce container of PDM each day,
the remainder of PDM after twenty-four hours had to be discarded. It was decided the NICU
PCTs would be responsible for the thawing and distribution of PDM. The NICU Nurse Manager,
NICU Quality Specialist, and PCTs outlined this process by constructing a process flow diagram
to identify all the steps in the process. The process flow diagram was then simulated to ensure no
steps were left out. Step by step instructions were developed from the process flow diagram that
was confirmed after simulation. Working from the list provided by the NICU dietician each day,
the day shift PCTs would call the bedside nurse caring for each infant on the list and obtain an
estimated twenty-four hour PDM volume. The PCT would thaw enough PDM to meet the
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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twenty-four hour needs of all infants receiving PDM in the NICU. The requested volume for
each infant would be placed in individual containers, labeled appropriately, and delivered to the
infant’s room. The PDM would be verified by the bedside nurse and placed in the breast milk
refrigerator located in each patient room. Thawing and creating aliquots of PDM occurred in a
designated area consistent with American Dietetic Association guidelines for management of
human milk in health care settings (Rosenbaum, 2012). Although the ultimate goal of this
process was to decrease waste of PDM, it was decided that measuring waste would be too time
intensive. Meetings were scheduled as needed with the PCTs to address any issues.
Possible Cost and Potential Savings
According to the annual NICU budget, the annual use of donor milk in 2012 prior to the
implementation of this project was approximately 250 ounces at a cost of $4.50 per ounce for a
total cost of $1125. It was difficult to estimate the additional cost of PDM because the number of
mothers who would consent to use of PDM was unknown and the total volume of PDM required
to supplement infants with inadequate supply of MOM was also unknown. Based on our less
than 1500 gram admissions (150 per year as per VON) and current breastfeeding rates, we
estimated PDM would equate to an additional cost of $8000 (average of 12 ounces per infant at
$4.50 per ounce) for a total of $9,000 annually. We also estimated it would take a PCT 1.5 hours
per day to order, thaw, and distribute the PDM; at an average hourly rate of $10, this added an
additional cost of $150 per week or $5880 per year. The total estimated annual cost of the PDM
program was an additional $13,880 ($5800 plus $8000). The NICU Nurse Manager accounted
for the estimated additional monies required to purchase PDM in the 2013 NICU budget.
The adjusted incremental costs of medical NEC and surgical NEC over and above the
average costs incurred for extremely premature infants without NEC in 2011 U.S. dollars, are
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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$74,004 (95% CI, $47,051-$100,957) and $198,040 (95% CI, $159,261-$236,819) per infant
respectively (Ganapathy, Hay, & Kim, 2012). In 2011 and 2012, there were twenty cases of NEC
(ten each year) in the NICU, the majority being medical NEC cases. Given the average cost of
medical NEC of $74,004, it was estimated that if we decreased our NEC rate by fifty percent
(five cases), our potential cost savings would be $356,140 ($74,004 x 5 minus $13, 880 [cost
of PDM]).
Outcome Evaluation
The outcome evaluation is separated into process, outcome, and balancing measure
evaluation; the major outcome evaluation in this case is NEC and cost savings. It is important to
have balancing measures in performance improvement projects to ensure that improving one
process does not negatively affect another equally important process. The balancing measure is
the percent of < 1500 gram infants discharged on MOM; a concern was that by introducing
PDM, fewer mothers would provide expressed breast milk.
Process Measures
1. Percent of mothers consented and percent of mothers consented prior to discharge
from postpartum is displayed in Figure 4. The results were tracked monthly by the
NICU fellow and shared at NICU Best Practice and with the NICU staff until we
reached eighty percent compliance for three months; compliance was achieved by
June 2013. PDSA cycles included staff education and revision of NICU admission
order set. Sustained improvement was not realized until the admission order sets were
revised to include an order to obtain PDM consent.
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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100
80
60
50
40
30
20
10
0
Jan-13
PDM consent obtained
Admit order set revised
70
Staff education
Percent compliance
90
Feb-13
PDM consent obtained prior to
mom's d/c
FAQ provided
Mar-13
Apr-13
May-13
Jun-13
Figure 4: Process measures related to consent process; Data source: NICU Fellow Quality
Project
2. The NICU fellow evaluated FAQ usefulness monthly by calculating the average score
of the survey responses for the month. Response range was 1-5 based on a 5 point
Likert scale with 1 being “not useful at all” and 5 being “very useful”. Mothers rated
the usefulness very high across a three month period (4.5-4.8). The FAQ was deemed
appropriate and useful by the NICU Best Practice Committee and no revisions were
made. Results were also shared with NICU staff.
3. The third process measure was the number of incidences that no PDM was available.
The NICU Nurse Manager was notified if this occured. This evaluated the reliability
of the PDM ordering process. There were no incidences in calendar year 2013. Given
that the ability to provide PDM hinges on the reliability of this process, this is an
ongoing process measure.
Outcome Measures
NEC was determined using the VON definition; the occurrence of NEC is entered into
the VON database by the Quality Specialist at infant discharge. Rates were tracked quarterly via
VON’s Nightingale which allows member NICUs to view and create reports. Our success was
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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greater than we had anticipated. We estimated a fifty percent reduction in NEC; we had no cases
of NEC in 2013 demonstrating a 100% reduction (Figure 5). In addition we overestimated the
cost of PDM; we estimated $8000 and actual cost of PDM for 2013 was approximately $7000.
Annual cost savings was estimated at $727, 160 (Figure 6).
Percent of infants with NEC
12
10
8
6
4
2
0
2010
2011
2012
2013
Target NICU
10.1
7.1
6.7
0
VON mean
5.7
5.2
4.9
4.9
Figure 5: Reduction of NEC with introduction of PDM program; Data source: VON
10 cases of
NEC at
$74,040 each
= $740,040
PDM cost
($7000) and
staff cost
($5880) =
$12,880
$727,160
cost
savings
Figure 6: Estimated cost savings for one year with introduction of PDM program
Balancing Measure
The percent of infants that received any PDM and percent receiving any MOM at
discharge to home were audited by review of the infant chart at discharge by the Quality
Specialist. Percent with any MOM at discharge is a data element available in VON. The data
reveal that despite the increased use of PDM over the year, the percent of infants still receiving
INITIATION OF DONOR HUMAN MILK IN THE NEONATAL
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any MOM at discharge continued to increase (Figure 7). This indicates that implementation of
the PDM project did not negatively affect this important outcome.
70
60
Percent
50
40
30
20
10
0
2010
2011
2012
2013
% receiving any MOM at d/c
to home
30.1
35.8
49.6
58.9
% receiving any PDM during
NICU stay
0
10
12
53
Figure 7: 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)
The preceding is a summary of an actual multidisciplinary performance improvement
project implemented in a large Level III NICU. This project demonstrates that quality
improvement methodology when combined with evidence-based practice is a very effective
combination to measure and affect successful change. Sometimes measured outcomes exceed
goals and expectations which is always a plus and a very rewarding team experience.
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