Human Milk Bank Processes: YOUR FACILITY AND LOCATION

NADIA GARCÍA LARA Mobile: 0034678307549 Email: [email protected]

Background info

How did your human milk bank (HMB) began? When?

Brief description

IT STARTED WORKING IN DECEMBER 2007 Who provided initial funding? How are ongoing operations funded? Integrated into government services?

Who regulates /oversees HMB in your country/region (if any)?

How many HMBs are part of your system? Where are they? Is there a central HMB that processes milk and distributes or many HMBs that process milk and distribute? (Centralized vs de centralized) How many NICU/Neonatal wards/community homes does each bank serve? Are they collocated? How many babies does your facility/system serve annually?

How many liters/year does your facility/system process annually?

FIRST FUNDING: SPANISH MINISTRY OF HEALTH ONGOING: HOSPITAL 12 DE OCTUBRE WHERE IT IS SET THERE ARE NO SPECIFIC LEGISLATION FOR HUMAN MILK BANKS in our country. 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 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. MY BANK SERVES 20 NICU beds, 26 neonatal wards and other children from Pediatric Intensive Care Unit, Pediatric Cardiology Unit, Toddlers Unit. IN 2011 IT SERVED 668 LITRES IN 2011 IT PROCESSED 670 LITRES How many donor mothers initiate donation to your facility/system annually?

IN 2011, 121 DONORS Page 2

Process

Staffing Donor recruitment Donor screening Recipient eligibility and selection

• • • • • • •

Brief description of processes

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 WE ARE PRESENT IN THE MAIN WEBPAGES RELATED TO PEDIATRICS, NEONATOLOGY AND BREASTFEEDING IN SPAIN BIANNUAL MEETINGS WITH PRIMARY CARE MEDIA (TV, RADIO, MAGAZINES) • • • • • • 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) 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

Process

Transport of milk

•

Brief description of process

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 Assessing milk quality and safety (ie. microbiology assays) Quality assurance

• • • • • • SPECIFIC DATABASE FOR HUMAN MILK BANK (DONORS, RAW MILK, PASTEURIZED MILK, RECIPIENTS) TEMPERATURES CURVES OF PASTEURIZATION FREEZERS TEMPERATURES FORMATION OF STAFF MEMBERS 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

Equipment/Location

What is used/how many?

Additional HMB equipment requirements?

Referral/feeder/depot facilities?

Neonatal ward equipment requirements?

Other?

• • • •

Brief description of process

• • • • • 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) • • • • • • Lockable room Computers: 2 Human milk analyser (2), US homogenizer Barcodes readers Labelling 3 Freezers and 1 fridge 2 thermostatic baths 5 fridges for human milk in different neonatal rooms Infusion pumps for human milk Dry-heaters Material given to donors: cool bags, dry ice, pumps, glass containers, personal labels, bags to sterilize pump parts at microwave

Policy

Organizational Successes

Brief description of top 3-5 successes

• Examples: National/regional policy and support for breastfeeding. Impact of breastfeeding promotion on HMB; impact of HMB on breastfeeding promotion.

Operational Technology

• • • • • 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) • Human milk analysers Page 6

Policy

Organizational Challenges

Brief description of top 3-5 challenges

• • • 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) Page 7