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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 Page 2 Process Brief description of processes Staffing • 2 FTE One manager, One Lactation Consultant. Plus casual 0.1 FTE when peak demand. Donor recruitment • 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 • • 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 • • • • 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 • • • 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 • • 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) • • 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? • • • 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 Page 6 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) Page 7