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Northwest Mothers Milk Bank

Human donor milk: Providing an educational module for


safe handling practices in clinical settings
12/06/2014
Community Outreach Project
Antoinette Kruger, Emily Cook, Grace Burlingame

Goal
This project aims to provide an online continuing education module to all
dietitians, nurses, and lactation consultants handling human donor milk in clinical
settings to ensure safe handling and distribution to infants.
Objective 1:
Participants will be able to describe the history and process of human donor milk
banking.
Objective 2:
Participants will successfully be able to describe Human Milk Bank Association of North
America (HMBANA) guidelines for safe handling of donor milk after completion of the
continuing education module, as evidenced by at least an 80% on an evaluation quiz.
Objective 3:
Participants will be able to list 3 benefits of properly handled human donor milk, as
evidenced by a minimum of 3 correctly chosen answers on the evaluation quiz to equal
a passing score of 80%.

Literature Review
It is well regarded among health professionals that breast milk is the ideal food for
infants optimal health and growth.(1, 2) When circumstances do not allow an infant to
breastfeed, the next optimal feeding choice is appropriately stored refrigerated mothers
milk, followed by frozen mothers milk. If mothers milk is not available, the next best
feeding option would be pasteurized donor human milk from a recognized milk bank.
When none of these are available, bovine infant formula would be the last choice for
infant feeding. (3)

Bovine and plant-based infant formula substitutes for human milk may approach the
same nutritional adequacy of fat, carbohydrate, and protein composition, yet, they
cannot replicate the species specific bioactive matrix found in human breast milk that
provides infants with numerous protecting health benefits against illness and disease:
bacteremia, diarrhea, respiratory tract infection, necrotizing enterocolitis (NEC), urinary

tract infections, late-onset sepsis in preterm infants, type 1 and type 2 diabetes;
lymphoma, leukemia, and Hodgkins disease; and childhood overweight and obesity. (2,3)
These protecting attributes of mothers milk become even more important to the feeding
and protection of compromised, high risk preterm babies in neonatal intensive care units
(NICUs) in the hospital setting.(1,3) The incidence of NEC in premature infants admitted
to NICUs in the United States varies between 6% and 10%. NEC is responsible for 1030% morbidity and mortality.(6) This rate has not decreased even with recent advances
in the care of extremely premature infants and the total cost of care is estimated to be
as much as $1 billion annually in the United States.(6) Studies have repeatedly shown
that mothers milk in preterm babies reduces incidence of NEC, NEC requiring surgery,
late-onset sepsis, and length of stay.
R.J. Schanler, R.J. Shulman, and C. Laus classic randomized study where a total of
108 infants were fed either exclusive mothers milk plus Enfamil Human Milk Fortifier
(FHM, n = 62) or exclusively preterm formula (PF, n = 46) found that infants fed FHM
were discharged earlier (73 19 vs 88 47 days). The incidence of NEC and late-onset
sepsis was significantly less in the FHM group. Overall, there were no differences in any
measure of feeding tolerance between the groups, but milk intakes of infants fed FHM
was significantly greater than those fed PF (180 13 vs 157 10 mLkg1day1). (4)
Sullivan et als randomized study confirmed these results. Infants fed their own mothers'
milk were randomized into 1 of 3 study groups. Two groups HM100 and HM40 were fed
pasteurized donor human milkbased human milk fortifier as a supplement to mothers
milk. Group BOV received bovine milkbased human milk fortifier and preterm formula if
no mother's milk was available. The 3 groups (total n = 207 infants) had similar baseline
demographic variables, duration of parenteral nutrition, rates of late-onset sepsis, and
growth. The groups receiving an exclusively human milk diet had significantly lower
rates of NEC (P = .02) and NEC requiring surgical intervention (P = .007).(5)

Furthermore, a meta-analyses of 4 randomized clinical trials supports the conclusion


that feeding preterm infants exclusive human milk significantly reduces incidence of
NEC in NICUs by 58%.(1) These studies conclude that extremely premature infants

should be fed an exclusively human milkbased diet (mothers milk plus a human milk
fortifier if necessary) to significantly lower rates of NEC and surgical NEC.

Yet, many mothers of preterm babies cannot produce sufficient amounts of milk to
sustain the baby or the hospital setting causes sufficient feeding of the baby to be
unmanageable. There is evidence that exclusive feeding of pasteurized human donor
milk can have similar protection for preterm infants as mothers milk against NEC, and
thus is a better alternative than a bovine preterm formula. Cristofalo et als blinded,
controlled randomized trial studied extremely preterm infants whose mothers did not
provide their milk. The infants were randomized into two groups. One group was fed
bovine milkbased preterm formula (BOV) diet. The other group was fed an exclusive
human milk diet of pasteurized donor human milk and milkbased human milk fortifier
(HUM) as necessary for nutritional needs. The major outcome was duration of
parenteral nutrition. Secondary outcomes were growth, respiratory support, and (NEC).
Birth weight and gestational age was similar in both groups. The study found a
significant difference in median parenteral nutrition days: 36 vs 27, in BOV vs HUM,
respectively (P = .04). More importantly, while the incidence of NEC in BOV was 21% (5
cases) vs 3% in HUM (1 case), P = .08 was not significant, but NEC requiring surgery
was significantly higher in BOV (4 cases) than HUM (0 cases) with a P = .04.

Current evidence shows that pasteurized human donor milk from a recognized milk
bank with a human milk based fortifier decreases NEC compared to formula and bovine
based fortifiers. This should become the preferred substitute to mothers milk in NICU
settings, yet more studies need to be conducted to establish a consensus among
health care professionals on feeding practices in preterm infants across NICUs in the
United States.(6) Furthermore, if this is to become a standard, evidenced based policies
and procedures need to be developed and put into practice to ensure safe use of
pasteurized human donor milk (HDM) in the NICU.

Clearly, human milk has many benefits to full term and preterm infants, but every step in
the collection and storage of human milk can affect its properties. Its caloric content,

immunologic function and nutritional value can all be compromised by improper


handling and storing. Human milk is a living tissue and thus there are many factors from
collection to storage to preserve its integrity. As long as human milk has been properly
handled and stored to regard it as bacteriologically safe, it is far superior for the infant
than any other replacement product.(1) Thus, it is important to provide preterm infants in
NICUs with this optimal food, but precautions have to be taken by hospital staff to
protect the quality of the final product fed to the infant.
Hand hygiene is the most important factor in the safe handling of human milk. Mothers
milk has bactericidal properties to protect the infant against the mothers skin flora, but
this does not protect the recipient infant against other handlers skin flora. Hand
hygiene can often be overlooked by hospital staff and result in nosocomial infections, a
leading cause of mortality and morbidity in NICUs.(7) Contamination of pasteurized
human donor milk by poor hand hygiene could have drastic effects on ill premature
infants in the NICU and very easily cause death.

(8)

A Hazard Analysis & Critical Control

Points (HACCP) study of HDM in NICU settings has found a critical control point in the
storing and handling of HDM to be the transmission of pathogenic bacteria, specifically
Staphylococcus aureus, especially Methicillin-resistant Staphylococcus aureus (MRSA)
strains found in hospital settings. (9,10) The occurrence of MRSA in samples of banked
human milk was investigated at 5 Brazilian milk banks by selective culture, antibiogram
and pulsed-field gel electrophoresis. MRSA contamination was found in 11% of the 500
samples of expressed, fresh-frozen milk from 500 different donors at five Brazilian milk
banks. (10) The study concluded that more research needs to be done to find the source
of MRSA contamination in HDM. While the HDM investigated in the study was raw and
not pasteurized as is mandatory by the Human Milk Banking Association of North
America (HMBANA) regulations in the United States, this study shows that HDM is a
reservoir for MRSA and can be introduced into milk by poor hygiene in the hospital
setting. It is very important for health care staff to learn and understand the risks of
handling HDM.

The largest concern in the storing of HDM in the NICU setting is the thawing and storing
process of frozen HDM. Frozen or pasteurized HDM has slightly less bacterial inhibition
factors and thus requires greater precaution in its storing and handling than freshlyexpressed raw milk. An analysis of HACCP critical control points of HDM storing and
handling of HDM in NICU settings found reheating and storing (at room temperature) of
milk to be a high risk critical control point. (9) Cohen et al investigated pasteurized donor
milk from a level 3 NICU that had been thawed, refrigerated, and used in a clinical
fashion by multiple nurses for multiple babies. They looked at 23 bottles thawed and
stored in the refrigerator, all of which were sterile. One bottle of milk was thawed for 12
hours at room temperature and then left on the counter for 12 hours; this bottle grew
100 colony forming units demonstrating the need for proper thawing and storage. (11)
HMBANA recommends HDM to be thawed and used within 24 hours and should always
be stored in the refrigerator. This is a conservative recommendation because of the
nature of the high risk population in the NICU setting. Yet, HACCP analysis studies
have found that milk was quite frequently left at room temp for up to 4 hrs in the
NICU.(9,12)

HMBANA guidelines mandate that a container of HDM must be completely thawed,


refrigerated, and used within 24 hours. This milk is not to be refrozen or only partially
thawed. In attempts to save money and milk, many NICUs will partially or completely
thaw, pour off, and refreeze milk. In both circumstances, this can lead to consequences.
Not only does this increase the likelihood of contamination, but also decreases the
nutritional content of the milk. A higher risk of contamination can occur due to more
handling and entry points of contamination when milk is partially thawed or fully thawed
and refrozen.

It is thought by hospital staff that this unsafe handling of HDM is extending the use of
the milk, lowering waste of milk, and saving the hospital money. Yet, studies show that
HDM in itself is saving hospitals money and thus staff should not be frugal with it. (13) The
risk of this unsafe handling could potentially lead to greater costs than throwing away
unused milk. A study of a San Diego NICU calculated that after the cost of HDM was

taken out, a hospital could save $8800 per infant with the use of HDM. This is only
direct cost and will vary by institution. The same study estimated that if donor milk is as
effective at preventing NEC and sepsis and shortening hospital stays as mothers own
milk (MOM), then for every $1 spent on donor milk, the NICU saves between $11 and
$37 in NICU costs. If the donor milk is only half as effective as MOM, then for every $1
spent on donor milk, the NICU will save between $6 and $19 in NICU costs.(13) It is
important for hospital staff to be educated that risks of unsafe handling outweigh
financial savings.

Furthermore, milk separates when expressed into a container and the fat freezes and
thaws at different rates than the water and protein. A container of milk must be fully
thawed and gently swirled to ensure uniformity. Since a premature infant in a NICU
might only need one or two milliliters at a time, it is important that the whole container is
uniform so that adequate nutrition and calories is in every milliliter being provided to the
every receiving infant. If a container is completely thawed, partially used, and refrozen,
this could possibly degrade the milks calorie, fat, vitamin A, and vitamin C levels, yet
more research is needed to confirm this hypothesis.
Significance
HDM is the best option for infants that are pre-term or in NICU and not able to receive
their own mothers milk. HDM is not always in full supply for NICU use, so NICU staff is
very creative when it comes to prolonging donor milk use. It has been found that HDM
in the NICU has been thawed, stored at length at room temperature, warmed for use,
and then refrozen to preserve the length of time to use that donor milk. The HMBANA
recommends using thawed HDM within 24 hours and to keep it refrigerated. HDM
should never be refrozen. HMBANA also mandates that donor milk should be
completely thawed before administering to an infant in the NICU. This is because the
nutritional properties of donor milk (fat, protein, etc.) thaw at different rates. The goal of
this project is to design a resource on how to handle donor milk in the safest way before
delivering it to NICU babies. This continuing education will be teaching the HMBANA
guidelines, which arent always followed or may be more strict than most hospitals

policies and procedures. With this education, it may also reduce hospital costs because
infants fed properly handled HDM have been shown to heal at quicker rates, ultimately
saving money from possible complications, surgery, or prolonged hospital stays.
Methods
Target Audience
This presentation will target RNs, lactation consultants, and RDs that handle human
donor milk in the clinical settings. The module will be sent to hospitals receiving HDM
from the NWMMB all of which are in Washington and Oregon.
Implementation Details
This community outreach project will be completed through an interactive training
module. Several topics will be covered in the training and it will be made available to all
hospitals receiving northwest mothers milk. The mentors, Joanne Ransom and Lesley
Mondeax, will coordinate with supervisors at individual hospitals to distribute the training
to their staff. As the mentors decide this may be sent out nationally through HMBANA.
The timeline for the implementation is shown in below.
Table 1: Implementation Timeline
Dates

Implementation

12/8/2014

Presentation to NUTN 510 class and mentors

January

Create training module: long and short version

January

Create presentation to prepare for OWLA meeting

February

Present during OWLA meeting, gather responses and feedback

February

Make revisions based on OWLA feedback

March

Present module to local hospital RN staff in person

March

Launch training module to all Portland area RN/LC/RD staff that


uses HDM

The module will be presented as a training that employees will complete and earn
continuing education credits for. The module will involve video recordings of interviews
with the clinical directors of the Northwest Mothers Milk Bank, a doctor, and possibly a
donor. This will create a more interesting and dynamic training. The module will also
include quizzes for more interaction with the viewer and will be between 30-60 minutes
long. The outline of the information the training will include is in Table 2.
Table 2: Presentation and Objectives
Presentation Component

Specific Content

Objectives Met

History of milk bank

Familiarize participant with


use of human donor milk in
the past

Objective 1

Milk banking process and


screening of donors

Describe how milk is


gathered and processed

Objective 1

Nutritional benefits to infant

Short clip of RD on benefits


of human donor milk for
infants

Objective 3

Cost savings of human


donor milk

Explain benefits of human


donor milk to hospital

Objective 3

HMBANA Guidelines

Thawing, storing, handling,


hygiene will all be covered

Objective 2

Post-test

Short exam after module to


determine if the participant
learned the material

Objective 1, 2, 3

Evaluation
Feedback and evaluation will be gathered at several stages of the project. At the
OWLA pilot presentation, an evaluation questionnaire will be filled out by all attendees
so improvements can be made before implementation. After the presentation at the
local hospital, participants will take a quiz to assess their learning. Finally, the module
will include a test that will be submitted online. This will show if the participants met the
objectives of the project. To meet the objectives the participant must score at least 80%
on the post test.
Facilities and Personnel Requirements
For the in-person presentations a projector, computer and printing capabilities will be
needed to present the module and collect evaluation of the project. To create the
module a designer or design company may be needed and a video camera will be
required to record interviews with key individuals for the module. The required
personnel are the three students at the in-person presentation and the mentors. For
further implementation Joanne Ransom and Lesley Mondeax will serve as technical
support in case the training does not work at a specific hospital.
Budget
Table 2: Itemized Budget
Item

Cost

Paper and printing

$50

Training module Designer

$5,000-9,000

Possible rental equipment: projector,


computer.

$100

Total

$250

References
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2. WHO. Infant and young child nutrition: Global strategy on infant and young child
feeding. Assembly 55/15. 2002.
3. JH Kim, S Unger; Candi Paeditrc Society Nutrition and Gastroenterology
Committee. Human Milk Banking. Paeditrc Child Health 201;5:595-8.
4. M. Ramani, N. Ambalavanan. Feeding practices and necrotizing enterocolitis.
Clin Perinatol 2013; 40: 110
5. R.J. Schanler, R.J. Shulman, C. Lau. Feeding strategies for premature infants:
beneficial outcomes of feeding fortified human milk vs preterm formula.
Pediatrics, 103 (1999), pp. 11501157.
6. Sandra Sullivan et al. An Exclusively Human Milk-Based Diet Is Associated with
a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine
Milk-Based Products. The Journal of Pediatrics 2010;156:s 562-567. DOI:
10.1016/j.jpeds.2009.10.040).
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Contamination of a milk bank pasteuriser causing a Pseudomonas aeruginosa
outbreak in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed
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9. Hunter P.R. Application of Hazard Analysis Critical Control Point (HACCP) to the
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http://www.sciencedirect.com/science/article/pii/019567019190178B#. Accessed
October 22, 2014.
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Banking Association of North America, Inc., 2011.
12. Cohen, R, et al Bacterial culture results of thawed banked human milk after
extended time periods. AAP National Conference. Atlanta, GA 2006
13. Cossey V, Jeurissen A, Thelissen M, Vanhole C, Schuermans A. Expressed
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http://www.sciencedirect.com/science/article/pii/S0196655311001672#.
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14. Lois D. W. Arnold. The Cost-effectiveness of Using Banked Donor Milk in the

Neonatal Intensive Care Unit: Prevention of Necrotizing Enterocolitis. J Hum Lact


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