Transcript Document

Mapping Processes of Human Milk Banking
Staffing
FTE
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Executive director/Manager
Medical director
Coordinator
Counsellor
Processing clerk/technician
Nutritionist
Nurse/Midwife
Staff sister
Shippers/Receivers
Part time/volunteer
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Treasurer
Chairperson (marketing, fundraising,
etc.)
Bookkeeper
Doctor/Medical officer
Advisory committee
Donor recruitment
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Mothers in NICU or Neonatal Unit
Antenatal clinics
Postnatal wards
Infant immunization clinics
Women's groups
Nurses in the hospitals, clinics
and IBCLCs
Lactation consultants
Local community outreach
Open days/talks presentations to
interested groups
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Print media: Pamphlets, posters
distributed to recipient hospitals,
clinics, birth educators, doctors rooms,
mothering groups, selected shops and
libraries.
Mass media: Radio, TV, Print media
Electronic media: Website, Facebook,
Twitter, email newsletters
Marketing essential as demand
always exceeds supplies and HIV rate
at hospital 25%
Advertising is not required. National
publicity via the media and social
network sites has made advertising
unnecessary.
Donor screening
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Lifestyle/health screening tool (custom or based on blood donor
screening)
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Serology test
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Self administered detailed health questionnaire (Post, email, online)
Telephone or face to face interviews
HIV, Hep B, Syphilis
Blood test results from medical history during pregnancy
Ongoing screening via health declaration made with each
donation
BMI
Hb
Consult with healthcare providers
Medication review by pharmacist and medical director
Final approval by medical director
Recipient eligibility and screening
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Donor milk is only supplied when prescribed by medical officer
Consent of the mother
Preterm less or equal to 30 weeks
When mothers have insufficient supply, severe maternal illness or absence
Premature and newborn infants of low birth weight that do not suck
Babies <1,500g or <1,800g
HIV exposed premature babies whose mothers have chosen to exclusively
breastfeed
Babies with tummy trouble or NEC
Post surgery
Consistently absent or reversed end diastolic flow
Haemodynamicall unstable babies who have received inotropic support
Newborns with NEC, immune deficiency; protracted diarrhea; allergy
sufferers will heterologous protein and other exceptional cases at the
doctor's discretion.
Handling and storage of donor milk
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Donors provided with verbal information and written pamphlets on labeling,
hygiene, storage and transport.
Donors deliver their frozen DEBM to ‘depots’ or is collected from their homes –
cooler boxes.
Collected from depots and stored in freezers until sorted and batched for
processing.
Mothers given sterile glass bottle into which to express breast milk. Before
expressing mothers wash hands and wipe breasts down with antibacterial swab.
Once milk is expressed mothers record donor number and date of expression
on bottle.
Milk is given to breast milk bank manager who immediately pasteurizes it and
after cooling freezes it or it can be placed in fridge for immediate use. If she is
too busy to pasteurize immediately, milk is frozen for later pasteurization.
The milk is then send to HMB in the Hospital for recording the details
When donation open to environment – under laminar flow cabinet
Appropriate PPE to protect product from staff
All processing steps are done under sterile conditions in Milk Kitchen.
Handling and storage of donor milk
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If in mother's home she is required to monitor and record freezer temperature
If stored in a hospital in monitored freezer
In milk bank: stored according to the stage in the milk banking process ie raw
milk is stored separately from pasteurized milk, screened milk is separate from
unscreened milk. All milk is stored separately according to the donor in
demarcated and labeled baskets.
Defrosted in fridge overnight.
Warmed-up milk to be used same day, or disposed of.
Breast Milk is safe for four to six hrs at room temperature i.e.- 15 to 25 deg
centigrade.
Milk for use allowed to warm up on bench
Thawed refrigerated milk is safe for 24 hours.
Fresh milk can be stored in the refrigerator for five to seven days
In the deep freezer at -20 deg centigrade for six months.
Screened milk kept in freezer compartment for max. 3 months.
Storage at -20C for 3 months pre pasteurization – 3 months post pasteurization
Transport of milk
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Milk delivered to and collected from depots in cooler boxes with ice bricks, by
mothers and staff.
Recipients hospitals responsible for PDEBM collection. We provide cooler boxes
and ice bricks if any driver collects without.
Use thick walled polystyrene containers sold for the purpose and with
detachable outer carrying case.
Done using vaccine carriers
Via medical couriers
Via ‘Blood Bikes’ (service operated by well trained volunteers)
Milk is transported via overnight express shipments,
Donors and recipients may come to the milk banks to deliver or pick-up the
milk.
Only local transport with hospital courier required
Recipient hospitals receive written Guidelines and sign a Memorandum of
Understanding accepting responsibility from time of collection.
Agreement among banks in internal document regarding distribution of milk
among banks for hospitals.
Pasteurization
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Pasteurized using Holder Method
• Automated
• Manual (Water bath)
Flash heat
Purpose designed and built human milk pasteurizers (fully automated) with
built in printer and in built milk cooling system.
Single Bottle Pasteurizer;
Pasteurize in 50ml and 100ml aliquots to prevent wastage.
Sealed and capped.
Place the vials containing milk to be pasteurized (with lid semi-closed)
Start timing of pasteurization according to curve pasteurization, agitating the
vials and noting the time every 5 minutes.
Pasteurization done at 60 degrees.
Pasteurization is done at 62.5*C for 30 minutes after the time of preheating.
By Shaker Bath method the containers are in shaker for 30 minutes on reaching
the temperature of 66 °C.
Tracking and record keeping
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Database includes donor and batch number, contact details,
dates of baby’s birth, blood tests, first and last donation,
quantities donated, recipient hospital and how donor learnt
about Milk Matters.
Records kept of Screening forms , Consent to HIV and Hep B
testing, donor pathology tests results and DEBM micro results.
Records kept of donor numbers, batches and quantities
processed daily.
Records kept of pasteurizing temperatures, fridges and freezers.
Records of recipient hospitals and babies (if known), donor
numbers and batches collected and signed for by recipient
hospital drivers.
All DEBM released can be back tracked to donor, test results and
processing records.
Tracking and record keeping
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Each pasteurization has batch number, temperature logging on phone
screen and can be relayed to remote server.
Each pasteurization has batch number, temperature logging on computer
Combination of electronic and paper. Use Excel spreadsheets to maintain
records and to audit activity
Tracking N/A.
As per Guidelines all steps must be tracked and records maintained for 21
years.
A mock recall in each member bank is required every three years.
Various data base and bar coding systems are used among milk banks. We
still maintain processing, donor and recipient data on hard copy as well.
Full traceability from every donation to every bottle dispensed to recipients
– currently transitioning from full manual paper based record keeping to
software ‘solution’
Records kept indefinitely (local requirement)
Assessing milk quality and safety (Pre-pasteurization)
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Micro results indicate type of organism and quantity, if found.
The microbiological quality of the milk is made by analyzing microbial
inoculation of milk samples in solution of brilliant green bile broth.
Tested either by standard pour plate method or streak method by hospital or
Public Health Lab.
Every pool of milk (500 – 800mls, single donor only) is tested pre pasteurization
A few milk banks test the raw samples for Bacillus, Staph A and MRSA.
Pre-pasteurization testing:
1) at the first donation
2) when the donor does not seem to guarantee appropriate hygienic
conditions
3) periodically, in a random way
Assessing milk quality and safety (Post-pasteurization)
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Regular cultures are done of each and every sample collected.
After they are opened 5 Ml of samples from each of these milk containers are
put in the sterile Test Tubes. Then they are sent for testing in the Microbiology
lab for culture test.
One sample taken from each donor batch post pasteurization of ± 1 liter or
less.
Micro assays on post pasteurization sample – one random sample per batch
and each new donor has first sample assayed.
Post pasteurization, sample from every batch should be <100cfu’s per ml.
Post pasteurization results must be <1 CFU/mL in order to be considered for
distribution.
Post-pasteurization testing:
1) in a regular way (e.g. once a month or every 10 cycles)
2) when there are concerns about the processing
At present the nutritional content of our milk is not assessed
Minority of banks are monitoring nutritional contents of milk.
Towards nutritional analysis and ‘lactoengineering’ (long term goal)
Quality assurance
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We provide donors with sterile containers. Containers are capped with
tamper proof seals prior to pasteurization.
Head quarters staff oversee and do actual processing at odd intervals.
Potential improvements are discussed and implemented if deemed
necessary.
Swabs taken from pasteurizer at random intervals.
Swabs taken from other areas in Milk kitchen at random intervals.
Visited by advisory team from Microbiology laboratory and implemented
their suggestions.
Pasteurizing temperature monitored and recorded.
Temperature control of freezers; temperature monitoring of pasteurizing and
cooling; batch numbers and donor number on each bottle; expiry date on
each bottle
Quality assurance
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HACCP
Audit of implementation of NICE guideline
Double checking and authorization of all test results
Annual calibration of equipment and follow maintenance schedule
Quality assurance is made ​according to the following parameters: Dornic
acidity, off-flavor, dirt, color and presence of coliforms.
Accredited microbiology laboratory and ISO-Certified NICU present.
HACPP guidelines, recall and tracking systems in place to report negative
findings, mandatory HMBANA Guidelines updated annually, certification
annually, some states have tissue banking requirements for milk banks,
Experts involved from FDA, CDC, Health Canada to upgrade standards,
advisory committees, annual Board of Director meetings of HMBANA
Code of Good Manufacturing Practice (Blood and Tissues) developed by
TGA. Incorporates our SOP’s and HACCP.