Transcript Document

Human Milk Bank Processes:
PREM Milk Bank, Perth Western Australia
Dr Ben Hartmann
PREM Milk Bank Manager
King Edward Memorial
Hospital
Subiaco
Western Australia
[email protected]
+618 9340 1563 (tel)
Background info
Brief description
How did your human milk bank (HMB) begin?
When?
Established while Postdoctoral Research Fellow, School of Women and Infants Health.
2005 (establishment), 2006 (clinical service to patients)
Who provided initial funding? How are
ongoing operations funded? Integrated into
government services?
Rotary (local), Perron Charitable Trust. Telethon (later – equip donated by Medela AG)
Operational costs now Govt funded. Equip is a mix of Govt and donation
Service is provided free to patient in our major public tertiary care maternity hospital
Who regulates /oversees HMB in your
country/region (if any)?
Self regulated – Under review of ‘Working Group’
How many HMBs are part of your system?
Where are they?
One officially – we work closely with other Australian milk banks
Is there a central HMB that processes milk
and distributes or many HMBs that process
milk and distribute? (Centralized vs decentralized)
Centralised maternity care in Western Australia – high risk patient transferred to our
hospital – as such we only need to service the one NICU (currently only level III unit in
State).
How many NICU/Neonatal wards/community
homes does each bank serve? Are they
collocated?
One NICU across two hospitals (KEMH is maternity hospital with 105 bed SCN, PMH is
children’s hospital with additional 25 bed SCN). Located in same suburb managed as
single unit
How many babies does your facility/system
serve annually?
300-400
How many liters/year does your
facility/system process annually?
1200-1500 L
How many donor mothers initiate donation to
your facility/system annually?
Approx 100
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Process
Brief description of processes
Staffing
•
2 FTE One manager, One Lactation Consultant. Plus casual 0.1 FTE when peak
demand.
Donor recruitment
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By our LC. Initiated by donor. Community profile is targeted to our local donor
population. Demand rarely exceeds supply – local community very engaged with milk
bank
Donor screening
•
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Equivalent to requirements for Blood and Tissue donation in Aust – additional
requirements similar to UK and US
Initial screen online, subsequent by interview (questionnaire and blood test)
Recipient eligibility and
selection
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As above
Medications reviewed by pharmacist and Medical Director as necessary
Donor management by LC has proven to be very necessary
Final approval by Medical Director
Handling and storage of
donor milk (from donation
to feeding)
•
Collection/storage instructions follow Australian guidelines (NHMRC) and are
consistent with international equivalents
Storage at -20C for 3 months pre pasteurisation – 3 months post pasteurisation
When donation open to environment – under laminar flow cabinet
Appropriate PPE to protect product from staff
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Process
Brief description of process
Transport of milk
•
Only local transport with hospital courier required
Pasteurization
•
Yes – Minimum standard of 30 minutes at 62.5C. Verified by independently calibrated
temperature data logger. Error of measurement and HACCP CCP requires
pasteurisation above 62.5C for full 30min
Tracking and record
keeping
•
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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 (ie. microbiology
assays)
•
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Pre and post microbiology (defined standards)
Towards nutritional analysis and ‘lactoengineering’ (long term goal)
Quality assurance
•
Developed around Code of Good Manufacturing Practice (Blood and Tissues)
developed by TGA. Incorporates our SOP’s and HACCP.
Equipment/Location
Brief description of process
What is used/how many?
• Pasteurizer Yes 1 (9L) plus 1 (business continuity 3L)
• Freezers (lockable?) Commercial 2x2 door 1xsingle door in secure
•
room (MB only access) – alarms to paging system
Refrigerators Yes 1 domestic – only used to ‘hold’ during processing
Additional HMB equipment • Ex. lockable room x2 private interview room essential
• Computers x2 (label printer)
requirements?
• Other Laminar flow cabinet, Calibrated temp probe
Referral/feeder/depot
facilities?
• How many? None
• Equipment requirements?
Neonatal ward equipment
requirements?
• System for tracking usage?
•
Manual – maintained by PREM Milk
Bank not by SCN (emergency use only)
Freezer? Milk room freezer available in SCN
Other?
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Nutritional analysis – MIRIS (+ultrasonic homogeniser and water bath)
Digital scales (lab)
Liquid handling - pipettes and metered peristaltic pump
Organizational Successes
Brief description of top 3-5 successes
Policy
• Australian National Breastfeeding Strategy 2010-2015 – acknowledged
need for risk management and quality control of milk banks (DHM for
preterm and ill infants only)
• Not recognised as ‘Food’ or ‘Therapeutic Good’ under current legislation
• ‘Working Group’ established by Australian Health Ministers Conference
– little progress since
Operational
• Not measured in research capacity – currently under audit.
• Pre milk bank NEC 2-5% (<29W) ie low and variable- any change won’t
be demonstrated under audit. Dramatic reduction in diagnosis of
‘suspected NEC’ since HMB est.
• Breastfeeding at discharge not detrimentally affected
Technology
• Less important
• More important – HMB as focus for research to understand physiology
of initiation of lactation (preterm) and support successful breastfeeding
in community
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Organizational Challenges
Brief description of top 3-5 challenges
Policy
• Uncertain regulatory environment = opportunity to lead process
• Lack of commitment to importance of breastfeeding = opportunity to
educate govt
• ‘confusion’ in positioning of milk banking – ie donor milk is not
equivalent to mothers feeding own baby = opportunity to educate
community
Operational
• Resource limitation = opportunity to be more efficient
• Centralised care model is changing in WA – there will be other level III
NICU’s that must have access to PDHM public/private funding will be
difficult to navigate = opportunity to secure direct funding for HMB
• Increased demand for PDHM = opportunity to reduce need for PDHM by
increasing preterm lactation success
Technology
• Not a priority
• Process with reduced protein damage (UV – PhD student)
• Assessment of bacterial safety needs complete rethink (microbiome)
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