1. Human Milk Bank Processes: YOUR FACILITY AND LOCATION NADIA GARCÍA LARA Mobile: 0034678307549 Email: nadiaraquelg@yahoo.es

2. Background info Page 2 Brief description How did your human milk bank (HMB) began? When? IT STARTED WORKING IN DECEMBER 2007 Who provided initial funding? How are ongoing operations funded? Integrated into government services? FIRST FUNDING: SPANISH MINISTRY OF HEALTH ONGOING: HOSPITAL 12 DE OCTUBRE WHERE IT IS SET Who regulates /oversees HMB in your country/region (if any)? THERE ARE NO SPECIFIC LEGISLATION FOR HUMAN MILK BANKS in our country. How many HMBs are part of your system? Where are they? IN SPAIN THERE ARE 7 HUMAN MILK BANKS (MADRID, VALENCIA, BARCELONA, MALLORCA, ZARAGOZA, MÉRIDA) AND WE ALL ARE ASSOCIATED IN SPANISH HUMAN MILK BANK ASSOCIATION ALTHOUGH WE DON’T HAVE THE SAME PROCEEDINGS Is there a central HMB that processes milk and distributes or many HMBs that process milk and distribute? (Centralized vs de- centralized) NO. AT THE MOMENT, WE ONLY DISTRIBUTE MILK FOR NEONATES AND TODDLERS ADMITTED IN OUR HOSPITAL. IT IS PROJECTED FOR NEXT YEAR TO START DISTRIBUTING TO OTHER HOSPITALS IN MADRID. How many NICU/Neonatal wards/community homes does each bank serve? Are they collocated? MY BANK SERVES 20 NICU beds, 26 neonatal wards and other children from Pediatric Intensive Care Unit, Pediatric Cardiology Unit, Toddlers Unit. How many babies does your facility/system serve annually? IN 2011 IT SERVED 668 LITRES How many liters/year does your facility/system process annually? IN 2011 IT PROCESSED 670 LITRES How many donor mothers initiate donation to your facility/system annually? IN 2011, 121 DONORS

3. Process Brief description of processes Staffing 2 LABORATORY TECHNICIANS TO PROCESS HUMAN MILK 1 NEONATOLOGIST TO RECRUIT DONORS AND DISTRIBUTE HUMAN MILK FOR RECIPIENTS EVERY WEEKDAY (part-time) 1 PERSON RESPONSIBLE FOR QUALITY 1 HUMAN MILK BANK MANAGER (She is also a neonatologist and recruit donors Donor recruitment WE ARE PRESENT IN THE MAIN WEBPAGES RELATED TO PEDIATRICS, NEONATOLOGY AND BREASTFEEDING IN SPAIN BIANNUAL MEETINGS WITH PRIMARY CARE MEDIA (TV, RADIO, MAGAZINES) Donor screening PERSONAL INTERVIEW HEALTH FORM FILLED AND SIGNED INFORMED CONSENT SIGNED NEGATIVE SEROLOGIES (NO MORE THAN ONE MONTH PRIOR TO THE FIRST DONATION) FOR VIRUS HEPATITIS B, C, VIH, HTLV I and II (for women from endemic areas) and TREPONEMA PALLIDUM. THE TESTS ARE DONE IN OUR HOSPITAL. WE DON’T ADMIT ANY SMOKERS AND ONLY OCASIONAL ALCOHOL CONSUMERS (NO MORE THAN 2 BEERS OR GLASSES OF WINE PER WEEK) Recipient eligibility and selection WE ADMIT POLYPROPILEN PLASTIC (AN ONLY USE) AND GLASS CONTAINERS (MULTIPLE USES IF THEY ARE NOT BROKEN). WE GIVE DONORS STERILIZED GLASS CONTAINERS AND STERILE LIDS Handling and storage of donor milk (from donation to feeding) ORAL AND WRITTEN HYGIENIC INDICATIONS FOR DONORS (HAND HYGIENE, USE OF MASK AND CAP, WASHING AND STERILIZING PUMP PARTS FOR EVERY USE) FREEZE IMMEDIATELY AFTER EXTRACTION (-18ºC) DONORS TRANSPORT FROZEN MILK TO MILK BANK IN COOL BOX/BAG WITH DRY ICE MILK STORED IN DEDICATED FREEZERS AT -20ºC UNTIL THAWING AND PASTEURIZATION

4. Process Brief description of process Transport of milk DONORS OR THEIR RELATIVES FROM THEIR HOMES TRANSPORT FROZEN MILK TO MILK BANK IN COOL BOX/BAG WITH DRY ICE. THAWED MILK IS DISCARDED. Pasteurization HOLDER PASTEURIZATION USING THERMOSTATIC BATHS (ONE TO HEAT AND THE OTHER ONE TO COOL) WE USE ICE TO OBTAIN A QUICKER FALL OF TEMPERATURE Tracking and record keeping SPECIFIC DATABASE FOR HUMAN MILK BANK (DONORS, RAW MILK, PASTEURIZED MILK, RECIPIENTS) TEMPERATURES CURVES OF PASTEURIZATION FREEZERS TEMPERATURES FORMATION OF STAFF MEMBERS Assessing milk quality and safety (ie. microbiology assays) BEFORE PASTEURIZATION (FOR EVERY BATCH) DORNIC ACIDITY (ADMITTED ONLY IF VALUES ARE LOWER THAN 8º) AND NUTRITIONAL QUALITY (PROTEIN, FAT, LACTOSE AND CALORIES USING HUMAN MILK ANALYSER WITH INFRARED TECHNOLOGY) AFTER PASTEURIZATION (FOR EVERY BATCH) MICROBIOLOGICAL CULTURE (BLOOD AND MC CONCKEY AGAR). ONLY <UFC BACILLUS SP ARE ADMITTED, ANY OTHER GROWING FORCES TO DISCARD THE WHOLE BATCH. Quality assurance FOR PROCEDURES, UNO EN ISO 9001: 2008 CERTIFICATION OBTAINED IN JUNE 2010 FOR 3 YEARS. YEARLY AND INTERNAL AND EXTERNAL AUDIT PERIODICAL CALIBRATION OF THERMOMETERS AND HUMAN MIK ANALYSER; VERIFICATION OF FREEZERS, FRIDGE, LAMINAR FLOW HOOD, PIPETTES, THERMOSTATIC BATHS. SATISFACTION SURVEY FOR DONORS AND PARENTS’RECIPIENTS

5. Equipment/Location Brief description of process What is used/how many? Lockable room: Pasteurizer: NO. We use thermostatic baths (3) Freezers (5 lockable/1 non lockable) Refrigerators:1 Calibrated data logger thermometers (4) Laminar flow hood (1) Additional HMB equipment requirements? Lockable room Computers: 2 Human milk analyser (2), US homogenizer Barcodes readers Labelling Referral/feeder/depot facilities? 3 Freezers and 1 fridge 2 thermostatic baths Neonatal ward equipment requirements? 5 fridges for human milk in different neonatal rooms Infusion pumps for human milk Dry-heaters Other? Material given to donors: cool bags, dry ice, pumps, glass containers, personal labels, bags to sterilize pump parts at microwave

6. Organizational Successes Page 6 Brief description of top 3-5 successes Policy Examples: National/regional policy and support for breastfeeding. Impact of breastfeeding promotion on HMB; impact of HMB on breastfeeding promotion. Operational Free donor milk High satisfaction of donors and parent’s recipients. Very good balance between quality of human milk and discarded milk (global losses 10-15%) Colostrum and transitional milk often availaible for very premature babies Different volumes to prevent discarding much milk and to address different recipients’ needs (30,60,120,240 ml) Technology Human milk analysers

7. Organizational Challenges Page 7 Brief description of top 3-5 challenges Policy No national or European regulatory legislation for human milk banks. Uncertain environment policy. Lack of policy level support for breastfeeding promotion. Operational. Scarcity of staff. Home collection. Delivery of human milk to other hospitals Technology Achieving optimal treatment for human milk (better balance than Holder pasteurization to obtain less wastage of biological properties and high microbiological safety) Increased efficiency of pasteurization cycles (more volume for every cycle)