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201705135

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UWHC,UWMF,

Policies,Administrative,UWHC,Department Specific,Clinical Nutrition,Administrative

Human Milk and Formula Storage, Preparation and Distribution (1.9)

Human Milk and Formula Storage, Preparation and Distribution (1.9) - Policies, Administrative, UWHC, Department Specific, Clinical Nutrition, Administrative

1.9

Human Milk and Formula Storage, Preparation and Distribution Policy

I. Purpose

To provide guidelines for receiving, storage, preparation and distribution of human
milk and formula in the Milk Lab that ensures safety and supports optimal nutrition
care.

II. Policy

Receiving, storing, preparing, and distributing both human milk and formula is the
responsibility of Clinical Nutrition Services. Duties and responsibilities are defined to
ensure safe and accurate administration of human milk and formula for patients.

III. General Information

A. The Milk Lab is a separate room designed for preparing human milk and formula
for American Family Children’s Hospital. Formulas and supplements prepared
from natural foods, e.g., blenderized tube feedings, milkshakes, or addition of
modular ingredients to natural foods, are not prepared in the milk lab.
B. Milk Lab technicians will be available from 8am-6pm Monday-Friday and 8am-
4:30pm weekends/holidays. No casual visitors are allowed in the Milk Lab.
C. Milk Lab will have designated milk and formula preparation times.
D. Standardized recipes for the preparation of human milk and formula are available
in the milk lab. Recipes are verified for accuracy by a registered dietitian/clinical
nutritionist. Any specialized recipes will be developed by the unit clinical
nutritionist and documented using the “Feeding Recipe” in Health Link.
E. The Milk Lab technician will coordinate with Lactation and parents to develop a
plan for safely storing excess milk at home
F. Pasteurized donor human milk and Prolacta, when ordered by the provider, are
obtained from the Milk Lab. The Milk Lab will only purchase donor human milk
from a HMBANA (Human Milk Banking Association of North America)
approved milk bank.
G. During feeding preparation times, traffic through the Milk Lab will be kept to a
minimum.
H. All personnel entering the Milk Lab must follow the same cleanliness standards
and dress code as the Milk Lab technicians and staff.
I. Eating and drinking are not allowed in the feeding preparation area.
J. Aseptic technique will be practiced in the preparation of all human milk and
formula. Aseptic technique incorporates proper hand hygiene with “no touch”
technique. Additional preparation instructions include:
1. Before any feedings are prepared, all work surfaces must be sanitized with
approved disinfectant. Allow area to air dry for a minimum of one minute.
2. Surfaces should be cleaned after any spills during the preparation process
and again at the end of the day’s feeding preparation.
3. Cleaning supplies will be stored separately from human milk or formula
products.

4. All equipment and utensils used in the preparation process will be
sanitized or sterilized prior to use. Single-use, disposable containers will be
used whenever possible. Equipment may be sanitized in the dishwasher.
5. Laminar airflow hood will be used in preparation of sterile products to
provide an additional barrier to potential contamination. Use of the
laminar airflow hood in preparation of powdered formulas should not occur
since these are non-sterile products and will not result in a sterile final
product. If powdered formula becomes airborne in a laminar flow hood, the
sterile environment is disrupted until the hood is terminally cleaned.
K. Bulk formula will be stored in the Milk Lab. Each patient care unit will have stock
of ready-to-feed formulas available in the nourishment kitchen. Clinical Nutrition
Services will be responsible for restocking and rotating supplies for unit
nourishment kitchens.
L. Refrigerators and freezers will be monitored per hospital policy.
M. Safe Baby is the barcoding system that will be used to scan and track the usage of
mother’s milk, donor human milk, and Prolacta to reduce the risk of
misadministration of human milk.
N. All milk will be properly labeled. Any milk that is found to be unlabeled or mis-
labeled will be discarded. Relabeling of mis-labeled milk is not permitted.

IV. Milk Lab Personnel

A. All Milk Lab personnel will receive training of sufficient duration and substance
by a qualified clinical nutritionist or nutrition technician. Training will include the
following:
1. Thorough understanding of the operation of the Milk Lab
2. Hand hygiene techniques and standard precautions of aseptic technique
3. Dress code
4. Care and use of equipment including techniques for cleaning and
sanitizing
5. Proper storage of human milk and formula
6. Use and development of standardized recipes
7. Formula and human milk product information
8. Preparation, packaging, and delivery of feedings for patients
9. Donor human milk and Prolacta usage and tracking
10. Labeling requirements
11. Inventory control
B. Milk Lab personnel will have yearly audits to ensure proper handling of human
milk and formula.
C. Milk Lab technicians are responsible for delivery of prepared human milk and
formula to the patient units at American Family Children’s Hospital.
1.If a patient at UWHC needs a feeding prepared outside standard mixing
times, the unit Clinical Nutritionist will enter the feeding recipe and contact
the Milk Lab technicians for preparation and delivery.
D. Below is the dress code required for all personnel who enter the preparation area
of the Milk Lab:
1. Remove all hand jewelry including rings, bracelets and watches

2. Fingernails should be short and unpolished. No artificial nails.
3. Latex-free gloves should be worn and replaced if soiled/torn.
4. Gown must be worn during milk preparation times. Should be replaced
each time the technician re-enters the preparation area of the Milk Lab.
5. Hair must be completely covered with a disposable bonnet during feeding
preparation. Facial hair must be covered appropriately. Bonnets and facial
hair covers should be worn and replaced each time the technician re-enters
the preparation area of the Milk Lab.
6. Closed toe shoes and socks should be worn at all times.
7. Surgical Mask must be worn during milk preparation times when
employee has minor respiratory illness.

V. Equipment Used

The following is a list of equipment that will be used in the Milk Lab. All equipment
will be used according to manufacturer’s instructions unless otherwise specified.
1. Hospital Grade Gram Scale to 0.1 gram
2. Can opener
3. Trays
4. Thermometers
5. Bins of adequate size to contain spills
6. Measuring devices:
i. Glass graduated cylinder for measuring liquids
ii. Glass beakers for weighing powders
7. Formula and human milk storage and mixing containers that are BPA-free and
food grade plastic
i. Bottles and syringes available in multiple volumes
8. Handheld whisk and/or Mixing spoons
9. Funnel & pinch cups
10. Household measures for discharge teaching
11. Syringes (5 mL, 10 mL, 30 mL, 60 mL)
12. Human milk warmer
13. Creamatocrit
14. Cart for delivery/transport of feedings
15. Cleaning supplies
16. Trash cans & recycling bins
17. Computer
18. Printer for labels
19. Refrigerator
20. Freezer
21. Hair nets/bonnets
22. Latex-free gloves
23. Gowns
24. Masks
25. Antiseptic spray or wipes for surface cleaning
26. Antiseptic hand gel
27. Paper towels

28. Step stool
29. Sterile water
30. Ink pens
31. Standardized recipes
32. Calculator
33. Centrifuge

VI. Procedures

A. Opening the Milk Lab and receiving human milk
1. The Milk Lab technician will print the feeding recipe shared patient list in
Health Link and the day’s patient census as reference for workload.
Review the daily milk preparation record from previous day.
2. Create any new patients in Safe Baby prior to making rounds. Label new
patient bins in the refrigerator and freezer.
1. Each patient will have a designated bin for human milk storage in
the refrigerator and freezer that will contain the patient’s name and
patient-specific barcode.
3. Check refrigerators for prepared milk and fresh milk quantities in the milk
lab. Discard any already expired milk. Scan and change status in Safe
Baby barcoding system for any milk that is moved or discarded.
4. Check donor human milk supply.
5. Collect fresh milk from the patient units or from the refrigerator either in
the patient’s room or the unit refrigerator. Place milk in the individual
patient labeled bins. Scan using Safe Baby barcoding system when moving
milk.
1. Only human milk that includes the following will be accepted for
storage in the Milk Lab:
a. Patient’s Name
b. MRN
c. Date and time expressed
d. Medications or supplements being taken by the mother
e. Patient specific barcode
2. Human milk received from a patient in isolation will be wiped clean
prior to removal from the room.
6. Place surplus fresh milk that has not expired and is older than 72 hours
into the freezer in the individual patient’s bin. Scan and change status in
Safe Baby barcoding system.
7. For those patients that have insufficient fresh milk supply available to fill
the patient’s diet order for the next 24 hours, begin thawing frozen supply.
Please refer to section “Human Milk Storage Guidelines” for how to
properly thaw human milk. Preference should be given to the oldest milk in
the freezer first when selecting frozen milk to thaw. Label milk with the
expiration date and time.
8. For those patients that qualify for donor human milk and do not have any
mother’s frozen milk supply available, begin to thaw sufficient quantity of
donor human milk for the next 24 hours. Please see section “Donor Human

Milk and Prolacta Specific Guidelines” for additional donor human milk
specific guidelines. Notify the patient’s mom, lactation, and RN of low
milk supply.
9.For lactating women that are pumping and are either admitted as a patient
or are the primary support of a patient in CSC or the ED, please refer to
Policy 8.28P.

B. Human milk storage guidelines
1. Fresh
1. Can be stored at room temperature (66-77 °F) for < 4 hours
2. Can be stored in the refrigerator (33-39°F or 0.5 to 4°C) for 96
hours
3. Fortified human milk can be stored in the refrigerator for a
maximum of 24 hours.
2. Frozen
1. Can be stored in the freezer (-4°F or -20°C) for up to 6-12 months.
3. Thawed
1. Human milk can be thawed in the refrigerator, using a warm water
bath, or milk warmer
a. Never submerse cap in water
b. Never use a microwave to warm or thaw human milk
2. Thawed milk should never be refrozen
3. Once thawed, can be stored in the refrigerator for < 24 hours
4. Donor human milk can be stored in the refrigerator for up to 48
hours if purchased from an approved donor human milk bank and
has been pasteurized.
4. If mother’s milk has expired according to AFCH guidelines for
hospitalized patients, but has not exceeded 8 days from time milk was
pumped, it is suggested to give milk back to mother to freeze and store at
home for use after discharge.
1. If patient’s family is not at AFCH to return milk, milk should be
labeled as “For home use only” until family is able to pick-up milk.

C. Mixing guidelines
1. Use Aseptic technique when preparing feedings with appropriate personal
protective equipment. Milk Lab technicians will use proper hand washing,
bonnets, gowns, and gloves will be worn while in the milk preparation
room.
1. Milk Lab techs will follow proper hand hygiene by washing hands
prior to cleaning surfaces and again between cleaning surfaces and
preparing milk. Hand washing between orders is expected and after
removing gloves. Antiseptic hand gels may be used and are
mounted in the milk prep area. Other non-milk tech personnel may
not use the sink in the milk prep room during the milk preparation
procedure.
2. Milk Lab technicians will clean off all work surfaces using approved
antiseptic according to directions for contact time prior to preparation of

milk and between orders on surfaces that come into direct contact with
milk.
3. Orders for feedings will be retrieved from the “Feeding Recipe”, “Diet
Order”, and “RN-Milk Lab Communication” within Milk Lab shared
patient list in Health Link. Check standardized feeding recipe for mixing
instructions.
4. Obtain supplies needed to properly mix feedings and print labels in the
clean room.
5. Measure ingredients using sterile or one-time-use equipment according to
the standardized feeding recipe.
1. Human Milk Specific Mixing Guidelines:
a. Once human milk is taken out of refrigerator, scan into Safe
Baby barcoding system to ensure the correct milk goes to
the correct baby.
b. The Milk Lab technician will measure the amount of human
milk and fortifier in a sanitized beaker based on the patient’s
diet order and using a standardized feeding recipe.
c. If powdered fortifier is being used and does not come in pre-
measured packet, weigh on a gram scale using a sterile
measuring device.
d. Gently stir the beaker after contents mixed to avoid breaking
the fat globules in human milk, which can result in fat
adhering to the container and loss of calories in the final
product.
e. Human milk with additives should be stored in the
refrigerator and used within 24 hours. Any remaining
fortified human milk after 24 hours should be discarded. For
low producing moms verify with unit RD and/or lactation
consultant prior to discarding milk. The unit RD and/or
lactation consultant will determine whether to allow the
feeding if it will be used within 28-hours from when it was
prepared.
f. Human milk with additives should never be frozen.
2. Formula Specific Mixing Guidelines:
a. Check the expiration date and examine containers for
physical damage, leakage, or swelling. Wipe opening
surface with an alcohol pad before opening.
b. Liquid concentrate and ready-to-feed formulas:
i. Shake formula before opening to ensure
homogeneity of contents.
ii. Once opened, store covered and labeled with date
and time opened in the refrigerator in the original
container for up to 24hours. Any unused formula
after 24hours should be discarded.
iii. Use designated amount of chilled sterile water or
ready-to-feed formula according to the feeding
recipe.

iv. Prepare under the laminar flow hood.
c. Powdered formulas
i. Only use powdered formulas when comparable
sterile liquid formula is not available.
ii. After opening, formula contents should be inspected.
Do not use if it appears abnormal (lumpy, grainy, or
clumped powder)
iii. Once can is opened, label with the date opened and
expiration date. Powdered formulas will be
discarded after one month. Store powdered formula
at room temperature, never refrigerate.
iv. Powdered formula should then be weighed using a
gram scale. Household measures should be avoided
whenever possible.
v. Use designated amount of sterile water or ready-to-
feed formula according to the feeding recipe.
vi. The laminar flow hood should not be used for
powdered formula preparation since powders are
non-sterile products and will not result in a sterile
final product.
6. The Milk Lab technician will dispense the appropriate volumes based on
the patient’s diet order as follows:
1. Bolus feedings: volume ordered for each bolus feeding will be
drawn into individual syringes.
2. Continuous feedings: volume needed for a 4-hour hang-time will be
drawn into individual syringes.
7.Re-label prepared feedings. Each label will include:
1. Patient name
2. MRN
3. Date and time mixed
4. Expiration date and time
5. Fortifiers added with final caloric density
6. Final volume per container
7. Initials of the person preparing the human milk
8. “For enteral use only”
9. “Hang time four hours”
10. “Refrigerate until used”
8. Labeled containers will be placed into individual patient bins labeled with
the patient’s name located in the pass-through refrigerator.
9. A new or sanitized container will be used to prepare each feeding to
prevent cross-contamination and misadministration.
10. The feeding preparation area will be cleaned between each feeding
preparation.

D. Distribution of prepared human milk and formula to patient units

1. Prepared human milk and formula feedings will be delivered to the
appropriate patient unit. Human milk will be scanned into Safe Baby
barcoding system once delivered to the unit.
2. Discard any expired human milk or formula remaining. For low producing
moms Milk Lab technician will clarify with unit RD and/or lactation
consultant prior to discarding milk.

E. Returning human milk at discharge
1. When a patient is ready to discharge home, transfer to another institution,
or death of a patient receiving human milk has occurred the Milk Lab
technician will obtain all human milk stored in the Milk Lab and be given
to the patient’s family. All milk leaving the Milk Lab will be scanned to
have status changed using Safe Baby barcoding system.
1. For mothers wanting to donate human milk, consult with a certified
lactation counselor to facilitate milk donation to a HMBANA milk
bank.
2. Verification with bedside nurse or Milk Lab technician and parents should
occur before milk is put in cooler. This can be done using Safe Baby
barcoding system.
3. Milk should be transported in cooler with chemical gel packs or
recommend use of dry ice when transit will be greater than 18 hours.

F. Closing the Milk Lab
1. The preparation area will be cleaned and sanitized with approved
disinfectant. First wipe away any visible debris prior to using disinfectant.
2. Run all used mixing utensils through the dishwasher using sanitation
mode.
3. Milk Lab technicians will document the number of feedings, milk
volumes, and additives used to prepare human milk and formula on the
daily milk preparation record.

G. Mixing afterhours
1. When possible and medically appropriate, use the lower calorie per ounce
ready-to-feed formula or unfortified human milk until the Milk Lab
technician can prepare during regular hours.
2. When a concentrated formula/fortified human milk is necessary or the
formula is not available in a ready-to-feed, only approved and properly
trained personnel should mix formula or human milk in the Milk Lab.
Approved personnel include, but are not limited to the following: care team
leaders, clinical nurse specialists, or nurse managers.
3. Use the standardized mixing recipes available in the Milk Lab for
accuracy.
4. Human milk and formula preparation during afterhours will follow the
same guidelines and procedures as used during regular business hours.
5. Human milk that has not been received into the SafeBaby software may
not be distributed.
H. Skimming Human Milk

1.Milk Lab will skim human milk using the refrigerated centrifuge for those
patients that need a low fat diet. See Appendix 3 for skimming human milk
procedure.

VII. Donor Human Milk & Prolacta Specific Guidelines
A. Donor human milk will only be purchased from a HBANA (Human Milk Banking
Association of North America) approved milk bank.
1. Those patients that bring donor human milk from home must sign the
Agreement to use Donor Human Milk Provided by Parent/Legal Guardian
consent form in order to use at AFCH.
B. Patients that qualify for donor human milk are the following:
1. All infants <2000 grams birth weight and for multiple births if at least
one multiple’s birth weight is <2000 grams.
i. Those who are ELBW and/or born at 23-26 weeks gestation should
use preterm donor milk as available for the first 4 weeks of life.
2. History of NEC or other GI anomalies
3. Infants with congenital heart disease
4. Post-surgical nutrition (PDA ligation, bowel surgery, etc)
5. Significant feeding intolerance
6. Malabsorption syndromes
7. Absent or insufficient lactation
8. Immunodeficiency disorders
9. Illness in mother requiring temporary interruption of breastfeeding
10. Neonates that are <1 week old and the mom has initiated pumping at the
delivery hospital, but there is no milk available yet. The baby may use
donor human milk for up to 7-days. Lactation and clinical nutrition will
discuss transition to infant formula after 7-days if mom’s milk supply is
insufficient.
11. Other indications per clinician’s discretion and must consult with RD
prior to use.
C. Patients that qualify for Prolacta include are all infants with birth weight <1250
grams. Patients must have signed consent form for donor human milk in order to
use Prolacta.
D. After the physician places an order for donor human milk, verify that the
“Agreement for Use of Donor Human Milk” consent form has been signed. If
consent form has not been obtain, the Milk Lab technician will contact RN or unit
RD to have form signed and delivered to Milk Lab.
E. Ordering, Shipping, Deliver, and Tracking
1.Please refer to procedure for Use of Donor Human Milk and Prolacta.
F. Guidelines for Using Donor Milk & Prolacta
1. Donor human milk and Prolacta should be stored frozen until time of use.
2. One bottle of donor human milk or Prolacta can be used for multiple
recipients.
3. Additional handling and mixing guidelines are the same as maternal
human milk guidelines.



VIII. Downtime Procedures
A. Contact the UWHC ITS Help Desk at 5-7777 to report the issue when Health Link
and/or Safe Baby are down.
B. Use a Health Link downtime shared workstation and login to the Health Link
downtime environment to print the “Feeding Recipe” shared patient list. This will
have the patient’s that require human milk or formula mixed up to the point at
which Health Link went down.
1.If unable to have access to Health Link, use the previous days milk
preparation form as guide for workload. Verify with RN or Clinical
Nutritionist any changes in diet orders.
C. When Safe Baby is down, there will be a two-person verification (i.e. milk
technician, RD, RN, etc.) when mixing human milk to prevent misadministration
and/or mixing errors.
D. Downtime supplies for labeling human milk and prepared feedings are stored in
the Milk Lab.
1. Only human milk that includes the following will be accepted for storage
in the Milk Lab:
1. Patient’s Name
2. MRN
3. Date and time expressed
4. Medications or supplements being taken by the mother
2. Re-label prepared feedings. Each label will include:
1. Patient name
2. MRN
3. Date and time mixed
4. Expiration date and time
5. Fortifiers added with final caloric density
6. Final volume per container
7. Initials of the person preparing the human milk
8. “For enteral use only”
9. “Hang time four hours”
10. “Refrigerate until used”
3. Re-label all human milk received during downtime procedures with new
patient labels that include a patient specific barcode. Document new
patients or changes into Safe Baby after recovery.
E. The Milk Lab will have Agreement to Use Donor Human Milk forms stocked for
use during downtime procedures.
F. Donor Human Milk usage will be documented on the Donor Human Milk and
Prolacta Tracking Form. Document any changes into Safe Baby after recovery.
G. Use the same mixing guidelines with the exception that a two-person double check
will be used when mixing human milk to reduce risk of misadministration.
H. The Milk Lab technician will continue to store human milk in individual bins with
the patient’s name and MRN for human milk stored in the Milk Lab and patient
units.
I. Use the daily milk preparation form to document all prepared feedings and transfer
of human milk that can be entered into Safe Baby after recovery.
J. Save all forms in appropriate location.

Appendix 1: Hazard Analysis and Critical Control Plan for Human Milk Handling

Process Step Hazard Policy/Criterion Monitoring Method Action Plan
(Criterion Failure)
Expression of
human milk
Contamination of
milk during
pumping



Improper cleaning
of kit
Mother should be instructed
to:
• Clean pump with
sanitizing cleaner
• Practice hand hygiene

Mother should be instructed
to:
• Wash kit in hot, soapy
water
• Rinse kit
• Air-dry kit between
uses
• Sterilize kit daily by
boiling for 15 minutes
or washing in
dishwasher
• Identify system for
daily kit sterilization in
hospital for mother not
able to go home
Observation,
surveillance




Observation,
surveillance
Reeducate mother





Reeducate mother
Labeling of
human milk
Improper labeling
by mother







Improper labeling
by nurses or milk
lab technician







Potential for
misadministration
Mother instructed to
complete label with name,
MRN, date and time milk
was expressed, milk fresh,
frozen, milk type (fore vs
hind), and medications or
supplements mother is
taking

Nurse &/or milk lab
technician to document on
the label if milk is fresh,
frozen, or thawed with the
date and time before
accepting. Once mixing
complete, use “post-
mixing” label and affix to
bottle. Scan into SafeBaby.

Scan into SafeBaby or have
nurse use 2 person check of
label against baby’s ID
band
Surveillance or
periodic monitoring







Chart review









Chart review
Reeducate mother.
Do not accept milk
until properly
labeled.





Reeducate nurses
and milk lab
technicians; continue
monitoring until
target goals are
achieved.




Reeducate nurses
and milk lab
technicians; continue
monitoring until
target goals are
achieved.

Transport of
human milk
Microbial
proliferation


Fresh or frozen milk should
be packed in cooler with ice
packs, not with ice. For
long-range transport, such
Inspect milk on
arrival. Store
immediately in
freezer if milk will
Discard milk if
>50% thawed.







Nutrient
deterioration
related to times or
temperatures




Potential for loss of
milk
as air transport to another
state, pack milk in dry ice.


Fresh or frozen milk should
be packed in cooler with ice
packs, not with ice. For
long-range transport, such
as air transport to another
state, pack milk in dry ice.


Hospital staff should accept
milk from mother after she
transports milk to hospital
or should instruct mother on
milk storage procedures.
Hospital staff should
transfer milk in cooler to
transport team for transport
to another hospital with
baby.
not be used within
72hours of time
pumped.

Monitor.







Communicate,
monitor




Discard milk if
transport
improperly;
reeducate mother;
review transport
process to avoid
future problems.

Reeducate mother
and staff.
Storage of
human milk
Microbial
proliferation and
nutrient loss due to
improper
temperature.








Nutrient
deterioration
related to storage
times.






Potential for
misadministration
Place milk in cooler,
refrigerator, or freezer
within 4 hours of pumping.
Use new containers at each
pumping. Do not add to
previously expressed milk.
Milk stored in refrigerator
should be maintained at 4
degrees C (40 degrees F).
Milk stored in freezer
should be maintained at -20
degrees C (-4 degrees F).

Fresh milk stored in
refrigerator should be used
within 96 hours. Milk
stored in freezer at -20
degrees C (-4 degrees F)
should be used within 6-12
months. Thawed milk
should be used within
24hours.

Store milk in individual
patient labeled bins in
refrigerator or freezer. Scan
using SafeBaby.

Monitor refrigerator
or freezer
temperature.










Check label for
expiration before
feeding.







Monitor.
Repair refrigerator
or freezer if it
remains out of range.
Ensure that freezer
& refrigerator doors
close securely.
Discard milk if
stored out of target
range.



Discard expired
milk.









Reeducate milk lab
technicians.
Thawing
human milk
Microbial
proliferation and/or
contamination



Estimate amount of milk to
be used for shift or day.
Place milk in refrigerator
for thawing at <40 degrees
If thawing for immediate
use, place in cool or
Monitor,
surveillance.




Discard milk.
Reeducate milk lab
technicians.













Loss of nutrients

lukewarm running water or
use milk warmer & ensure
thawing is completed in
<15 minutes. Do not allow
cap to touch water. Never
leave milk unattended in
sink. Do not place milk in
the hand washing sink.

Do not use microwave or
hot water to thaw milk.









Monitor,
surveillance










Discard milk
Preparing
human milk
for feeding
Microbial
proliferation and/or
contamination
Prepare milk in clean area
with aseptic technique. Use
sterile or clean containers,
lids, and nipples.
Human Milk should be
warmed to body
temperature for oral feeds
immediately prior to use.
Do not warm for tube
feeding. Discard milk that
has been warmed but not
used.
Monitor,
surveillance.
Reeducate staff.
Human milk
fortification
Microbial
proliferation and/or
contamination.
Use packets of fortifiers or
premeasured units of
additives.
Use sterile liquid additives
when possible.
Monitor,
surveillance.
Reeducate staff.
Feeding human
milk
Infant receives
someone else’s
milk
Use SafeBaby barcoding
system or use two-person
check of label and ID
before feeding.
Monitor,
surveillance.
Reeducate staff.
Enteral
nutrition
support
Micriobial
proliferation



Loss of fat
Limit the hang time to 4
hours for continuous
feedings. Change syringe
and tubing every 4 hours.

Orient syringe upward at
25-40 degree angle.
Use bolus feeds when
possible.
Monitor,
surveillance.



Monitor,
surveillance.
Reeducate staff.




Reeducate staff.














Appendix 2: Hazard Analysis and Critical Control Plan for Formula Handling
Process Step Hazard Policy/Criterion Monitoring
Method
Action Plan
(Criterion Failure)
Purchasing Contamination of
formula by chemical,
microbiological, or
particulate matter;
breakdown in quality
control at point of
production
Purchase from approved
inspected and certified
vendors.
Donated formula from
families will not be used
for patient
administration.
Monitor vendors
for adherence to
purchasing
specifications.
Inspect delivery on
receipt.
Without exception,
reject delivery no
adhering to
specifications.
Follow recall
procedures to address
quality control issues.

Receiving Contamination of
formula by chemical,
microbiological, or
particulate matter,
through improper
receiving methods.
Verify delivery based on
receiving criteria.
Do not accept damaged
or bulging cans or
products.
Check expiration date
according to hospital
guidelines.
Immediately remove
received products for
appropriate storage.
Monitor receiving
process.
Coach/counsel
employees on how to
properly receive
products.
Storage Contamination of
formula by chemical,
microbiological, or
particulate matter,
due to improper
storage and handling
procedures
Ensure first-in-first-out
(FIFO) safety standards
in all storage areas.
Remove dented cans
from circulation.
Identify or discard
products with improper
labeling.
Date products upon
opening, indicating the
date on which the
product expires once
opened.
Use powders within 30
days of opening.
Monitor product
expiration dates
Discard products that
have exceeded
expiration date as
noted by the
manufacturer.
Discard individual
dented cans and report
to
manufacturer/vendor.
Coach/counsel
employees in
monitoring and action
procedures.
Preparation Introduction of
microbes, chemicals,
or particulates, by
process, equipment,
cross-contamination,
and/or employees.
Employees trained in
proper formula handling
techniques and
sanitation.
Wash hands before
preparing formula or
modular components.
Prepare according to
feeding recipe.
Sterile water is used for
formula reconstitution.
Clean and sanitize
equipment and utensils
before use.
Protect formula from
cross-contamination.
Properly label product.
Verify cleaning and
sanitizing process.

Verify adherence to
formula orders and
feeding recipes.
Discard formula
ingredients in
question.

Reject ingredients not
meeting acceptable
criteria.

Coach/counsel
employees in proper
formula preparation
methods.

Keep records of
competency
documentation.

Cold holding Spores germinate and
microorganisms
multiply at
temperatures >4
degrees C (40 degrees
F)
Discard any open
container of formula that
has been unused after 24
hours.
Label, seal, and date
opened bottles of
formula or modular.
Seal and properly label
all reconstituted, bagged,
or bottled formula and
modulars.
Store all prepared
formulas under
refrigeration <4 degrees
C (40 degrees F) until
delivery to patient care
areas.
Verify temperature
accuracy of refrigeration
monitor.
Inventory products to
detect items at or near
expiration.

All ready-to-feed
formulas and opened
containers of powdered
formula are discarded
after the expiration date.
Monitor
refrigeration
temperature and
verify accuracy of
temperature device.
Conduct daily
inventory of
prepared or open
formula products.
Monitor refrigeration
temperature for <4
degrees C (40 degrees
F). If temperature
standards are not
being met,
immediately move
prepared or opened
enteral feeding
products to a
refrigerator that
maintains the required
temperature.

Coach/counsel
employees in enteral
product monitoring
methods.

Discard formulas that
have exceeded shelf-
life criteria.
Delivery to
unit:

Surviving
microorganisms can
grow in inadequately
maintained mixed
formula products.
Spores can survive
and begin to grow
during the inadequate
refrigeration holding
process. Chemicals
and particulates
cannot be destroyed.
Maintain safe formula
temperature (<6 degrees
C [45 degrees F]) during
transportation and
delivery to patient care
areas.
Appropriate
monitoring of time
to complete
delivery and
formula
temperature during
transport should be
in place.
Test temperature of
sample formula at
the end of the
delivery process.
Formula
unrefrigerated for >4
hours should be
discarded.
Administration All products, at room
temperature, can
support microbial
growth.
Formula
manipulation or using
procedures that
increase handling of
formulas or
administration
systems increase the
potential for
contamination.
Wash hands before
handling enteral nutrition
formula and
administration systems.
Avoid touching any part
of the container or
administration system
that will come in contact
with the feeding.
Inspect seals and
reservoirs for damage
before each use.
Each
container/administration
system is dated and
Monitor staff for
adherence to proper
enteral nutrition
administration and
aseptic technique.
Discard products that
have exceeded limit of
hang time.
Coach/counsel staff
on proper enteral
nutrition
administration
procedures.

indicates the patient’s
name and formula.
Hang time of all
prepared formula
admixtures is limited to
four hours.

Enteral feeding systems
should not be reopened
or compromised.

Sterile water should be
used for flushes and to
make half-strength
dilutions.
Sanitize Destruction of
microbes during the
cleaning and
sanitizing process.
Introduction of
microbes, chemicals,
or particulates, by
cross-contamination
and/or employees.
Train employees in
proper techniques for
formula handling, aseptic
technique, and sanitation.
Clean and sanitize
equipment and utensils
before use and between
uses.
Protect products from
contamination.
Verify cleaning and
sanitizing process.
Observe that
separation of
formula preparation
and storage from
sanitation processes
is maintained.
Re-clean and sanitize
all preparation
equipment.
Couch/counsel
employees in proper
sanitation procedures.
Discard formula
contaminated during
sanitation process.

Appendix 3: Procedure for Skimming Human Milk

Infants with chylous pleural effusions are treated with low long-chain fatty acid diets. This
can be achieved by removing the fat portion from human milk in order for the infant to
receive the immune factors and other nutritional benefits of human milk without exacerbation
of symptoms. A Milk Lab technician will ideally use a refrigerated centrifuge to adequately
remove the fat portion of human milk. If the centrifuge is not operational or for those
discharged home, manual removal of the fat from human milk should occur.
Procedure for use of refrigerated centrifuge:
1. Turn centrifuge on using rocker switch on back left hand side of machine. Allow 5-10 min
for machine to reach appropriate temperature (2⁰C).
2. Fill an even number of centrifuge tubes with an equal amount of human milk per tube; the
centrifuge will only run if balanced. Number original human milk bottles in
correspondance to where the filled centrifuge tubes are placed within the rotor in order to
keep track of expiration dates. Please note that each centrifuge tube holds 80 mL max.
3. Tightly screw lid on rotor, let rotor slide into place within the centrifuge and close
centrifuge lid. Make sure button #1 is lit up (programmed for 3000 rpm for 15 min @
2⁰C). Press start.
4. Once centrifuge displays ‘end run’ remove rotor and place under the hood. Obtain a 60
mL syringe and 6-inch sampling straw; attach straw to syringe.
5. Carefully place the tip of the straw down into the skimmed portion of milk, pull back on
syringe to obatin the skim milk while leaving the fat in the centrifuge tube.
6. Transfer the skim portion of milk into a clean container. Transfer the fat portion into the
original HBM container. Use SafeBaby to fill the new skim milk containers. Properly
label containers as ‘skimmed milk’ or ‘fat portion of skimmed milk’.

7. Turn off centrifuge. Wipe inside chamber of centrifuge and rotor down with a small
amount of Neutral Disinfectant Cleaner. Use a 1 mL syringe to apply a small amount of
corrosion protection oil to aluminum auto-lock shaft within centrifuge. *Do NOT use
bleach or Cavi wipes*
8. Wipe rotor down with small amount of Neutral Disinfectant Cleaner, wipe/rinse with
damp paper towel, wipe dry, and place in refrigerator bin with cavities pointing down .

Additional info for outpatient milk skimming using the refrigerated centrifuge
1. Milk Lab will only take fresh milk for skimming
2. Milk must have two forms of identification as well as the date pumped. The HUC can
send Health Link stickers home with family at time of discharge which will include the
patient’s name, date of birth, and medical record number.
3. Families will be instructed to contact the Milk Lab 2 to 3 days before they need more
skimmed human milk. The Milk Lab will coordinate the date and time milk will be
brought in as well as the time for pick-up.
4. The Milk Lab must obtain a signed Human Milk Skimming Information and Agreement
(301758-DT) form before skimming and a signature after skimming to ensure the correct
milk is delivered to the correct patient. The Milk Lab will have the signed agreement form
scanned into the patient’s medical record.
5. The Milk Lab technician will fill out the outpatient skimming tracking form. Refer to
Appendix 4.
6. The Milk Lab technician will complete a “Clinical Info Note” in Health Link using the
SmartPhrase .SKIM. Refer to Appendix 5.

Procedure for manually skimming human milk:
1. Use fresh or thawed frozen milk in original container.
2. Allow milk to sit undisturbed in the refrigerator located in the Milk Lab. Be sure to place
milk in the patient’s labeled bin and document status change in Safe Baby. This will
allow the fat to rise to the top and time required will vary, typically 8 to 12 hours.
3. Obtain a 60 mL syringe, nasogastric (NG) tube, and sterile empty container to draw off
the fat-free portion of milk.
4. Attach syringe to NG tube.
5. Carefully place the tip of the NG tube down to the bottom of the milk storage container
underneath the fat layer. Be sure to keep fat layer intact for optimal results.
6. Pull back on the syringe to obtain the skim milk, leaving the fat layer in the container.
7. Transfer the skim milk from the syringe to the empty container.
8. Repeat the process as needed to ensure complete fat removal.
9. Using the Creamatocrit Plus ™ Centrifuge, measure the caloric density and fat content of
skimmed milk samples. Aim for the caloric density to be 10-12 kcal/oz and less than 1 g
fat/dL remaining.
a. If creamatocrit is greater than 12 kcal/oz or has greater than 1 g fat/dL, repeat
process until goal achieved.
10. Re-label the skim milk and fat including the following:
a. Patient Name
b. Medical Record Number
c. Date and Time milk was skimmed
d. Expiration date and time

Appendix 4: Outpatient Human Milk Skimming Log

AMERICAN FAMILY CHILDREN’S HOSPITAL
Outpatient Human Milk Skimming Log

Date Patient
Volume (mL) HBM
before skimming
Volume (mL) skim
HBM after
skimming
Time (hrs & mins)
from start-finish
Tech
Initial







































Please retain for milk lab records.


Appendix 5: HOW TO: Clinical Info Note

1. Log into HealthLink under department: AFCH Clinical Nutrition
2. click on ‘Amb Enc’ on the top of the screen
3. look up patient
4. click ‘New’ in the encounter selection box
5. fill in the following info:
a. type: Clinical Info Note
b. provider: your name
c. department: AFCH Clinical Nutrition
6. use SmartPhrase .SKIM to compose note


References:
1. Chan GM, Lechtenberg E. The Use of Fat-Free Human Milk in Infants with Chylous
Pleural Effusion. Journal of Perinatology. 2007. 27;434-436.
2. Lessen R. Use of Skim Breast Milk for an Infant with Chylothorax. ICAN: Infant, Child,
and Adolescent Nutrition. 1(6);303-310.



















SIGNED BY:

Megan Waltz, MS, RD, CNSC
Director, Clinical Nutrition

Sue Rees, DNP, RN, CPHQ, CENP
VP Development, Nursing & Patient Care Services