Human Milk Bank Processes: YOUR FACILITY AND LOCATION Guido E. Moro, MD President of Associazione Italiana Banche del Latte Umano Donato (AIBLUD) Milan, Italy Email: guidoemoro@tiscali.it Tel.: +39 3485659614

TWENTY- SEVEN MILK BANKS IN 2012 HUMAN MILK BANKING IN ITALY: TWENTY- SEVEN MILK BANKS IN 2012 TRENTINO ALTO ADIGE Trento Dr. Giuseppe De Nisi, Head Nurse Maria Luisa Zattoni LOMBARDIA Milano PIEMONTE Torino Prof. Enrico Bertino, Head Nurse Elisabetta Punziano Moncalieri Dr. Antonio Marra, Ms Patrizia Soriani Friuli Venezia Giulia Udine Head Nurse Monica Fantini Pordenone Dr.Alberto Coprivez, Head Nurse Helene Huber, Ms Gianna Polletti VENETO Camposampiero Prof. Carlo Zorzi, Head Nurse Mariuccia Bruseghin Treviso Prof. Onofrio Sergio Saia EMILIA ROMAGNA Cesena Dr. Augusto Biasini Modena Prof. Fabrizio Ferrari, Dr. Bruno Mordini, Head Nurse Giovanna Cuomo Reggio Emilia Dr. Giancarlo Gargano, Dr. Claudio Rota TOSCANA Arezzo Dr. Pier Giorgo D’Ascola, Ms Manuela Caneschi Firenze Dr. Claudio Profeti, Dr. Fina Belli Grosseto Dr. Rita Bini, Ms Sandra Novelli Lido di Camaiore Dr. Ilaria Merusi, Ms Alessandra Manfredi Lucca Dr. Raffaele Domenici, Dr. Simona Tognetti, Ms Bruna Giampaoli Siena Prof. Mirella Strambi, Ms Angela Polese ABRUZZO Chieti Dr. Mariangela Conte, Ms Lucilla Campione PUGLIA Bari Dr. Antonio del Vecchio, Ms Ottavia Binetti Foggia Dr. Giovanna Minelli, Dr. Rosario Magaldi San Giovanni Rotondo, Foggia Dr. Alberto Gatta, Dr. Antonio Villani, Dr. Pasqua Quitadamo LAZIO Roma Dr. Giuseppe Morino, Dr. Anna Maria Cappelli CALABRIA Cosenza Dr. Maria Pia Galasso, Ms Francesca De Luca Crotone Dr. Massimo Bisceglia, Dr. Vincenzo Poerio SICILIA Agrigento Dr. Adriano Azzali, Head Nurse Fazeo Gioachino Palermo Dr. Iwona Kazmierska FOR COMMUNICATION Italian Association of Human Milk Banks - Associazione Italiana Banche del Latte Umano Donato (AIBLUD) Adress: c/o Biomedia, Via Libero Temolo 4, 20126, Milan, ITALY Website: www.aiblud.org Secretariat: Cristina Benelli Tel.: 02 2893631

Background info Brief description How did your human milk bank (HMB) began? When? Collecting Human Milk to feed premature infants admitted to the NICU of Macedonio Melloni Maternity Hospital, the second largest maternity in Milan. It began in the year1985. Who provided initial funding? How are ongoing operations funded? Integrated into government services? It started as a Service of the Hospital. Part of the funds were given from the Italian National Council of Research, part from private donation, and part from the Hospital. After that, it became a regular service supported by the hospital (National Health Service). Who regulates /oversees HMB in your country/region (if any)? No “official” organization regulates/oversees HMB. The banks are following the Italian Guidelines published in 2005, revised in 2007 and in 2010. In the year 2012, Italian National Recommendations for the Organization and Management of HMB have been published as the result of a cooperation between the Italian Ministry of Health and the Italian Association of Human Milk Banks (AIBLUD). According to this agreement, the National Health Service will monitor the functioning of HMB through AIBLUD. How many HMBs are part of your system? Where are they? 27 (26 are included in hospitals and belong to the Public Health Service, 1 bank is managed by a private diary company). They are located mainly in the North and Center of our country. Is there a central HMB that processes milk and distributes or many HMBs that process milk and distribute? All the banks are processing and distributing the milk. How many NICU/Neonatal wards/community homes does each bank serve? Are they collocated? The majority of the banks are serving mainly their own NICU, but some are serving also 2-3 other NICUs of the same region. How many babies does your facility/system serve annually? All the babies with a BW < 1800 g admitted to the NICU (app. 90), plus the infants < 1250 g admitted to the NICU of Lecco Hospital (app. 20 babies), plus 25-30 external babies. How many liters/year does your facility/system process annually? In the year 2010 we have collected and processed 1,500 liters of donated human milk. How many donor mothers initiate donation to your facility/system annually? In the year 2010 we had 222 donors (135 internal mothers of premature infants, and 87 external mothers of term infants).

Process Staffing Donor recruitment Donor screening Brief description of processes Staffing 1 full time nurse 1 part time doctor Donor recruitment Interview Donor screening Life style Maternal therapies Maternal diseases and serological testing Recipient eligibility and selection According to the Italian Guidelines (Journal of Maternal-Fetal & Neonatal Medicine’s, September 2010; 23(S2): 1-20) Handling and storage of donor milk (from donation to feeding)

Process Transport of milk Pasteurization Tracking and record keeping Brief description of process Transport of milk Home service with a car of the hospital Pasteurization Holder pasteurization Tracking and record keeping Routinely performed Assessing milk quality and safety (ie. microbiology assays) 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 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 Quality assurance According to the principles of Hazard Analysis and Critical Control Points (HACCP)

Equipment/Location What is used/how many? Brief description of process What is used/how many? Pasteurizer: 1 Sterifeed Freezers: 3 freezers at – 20°C Refrigerators: 2 refrigerators Additional HMB equipment requirements? Computer : 1 devoted to the bank Other : Milk Scan Analyzer (Foss Electric); osmometer (De Mori) Referral/feeder/depot facilities? How many? Equipment requirements? Neonatal ward equipment requirements? System for tracking usage? Freezer? Other?

Organizational Successes Brief description of top 3-5 successes Policy National policy and support for breastfeeding. Impact of breastfeeding promotion on HMB; impact of HMB on breastfeeding promotion (increased number of breast feeding mothers at discharge home in the NICU with a HMB: national survey. Exclusive breastfeeding at discharge in the 19 NICU with HMB 29.6% vs 16% of the 64 NICU without HMB. Any breastfeeding 60.4% in NICU with HMB vs 52.8% in NICU without) . Operational Impact of HMB on infant health outcomes (reduced incidence of NEC, sepsis, and better feeding tolerance). Utilization of donated human milk in the nursery (supplementation of mother’s milk in term infants in the first days of life in specific circumstances: e.g. excessive loss of weight, dehydration). Technology Macronutrient evaluation of donated human milk, and storage of the milk according to the protein content.

Organizational Challenges Brief description of top 3-5 challenges Policy Lack of interest from Regional Government Economical crisis Some neonatologysts do not believe in HM for feeding VLBW infants Operational Continuous update of the staff to maintain a high level of qualification. Technology Pasteurization method should be improved to preserve better the nutritional and biological quality of human milk, maintaining at the same time the microbiological safety of the final product.