1. Human Milk Bank Processes: Human Milk Bank System in Brazil Sergio Duarte Segall, Ph.D Path Consultant in Brazil +55 31 3022-4664 +55 31 9134-8886 sergiosegall@yahoo.com

2. Background info Page 2 Brief description 1940 IFF (Instituto Fernandes Figueira) The Human Milk Bank of the Instituto Fernandes Figueira has a direct relationship with the directions of the history of Human Milk Banks in Brazil. By being the first unit in operation between 40's and 70 it served as model institutions, replicating the proposal to operate exclusively with the collection and distribution of milk human, without developing promotional activities, protection and support breastfeeding. From 1943 to 1985, the main problem was the need to increase the volume of milk collected. The search for an effective program that allows to expand the collection was always the subject of major concern. With the development of the National Program for Encouraging Breastfeeding - PNIAM in 1981 in Brazil, it was observed social mobilization in favor of using human milk, which culminated in a kind of stimulus the deployment of Milk Banks, with the objective of promoting the service in times of urgency, for infants unable to be clinically directly breastfed by their mothers.

3. Financial support Page 3 Brief description State and Municipal governments National Council for Scientific and Technological Development (CNPq) Ministry of Health The Compromises of MOH with RNBLH are: 1 - Expanding the Network of Human Milk Banks 2 - Updating the information system 3 - Implementation Phase II of the National Quality Program in Human Milk Bank - PNQBLH 4 – Boost the HMB into the SUS – National Health Service belongs to the MOH 5 - Revisit the National Commission on Human Milk Banks - CNBLH 6 - Supporting the State Commissions of Human Milk Banks - CEBLH and the State Reference Centers 7 - Create the Latin American Network of Human Milk Banks 8 – Coordinate the National Campaigns like the NATIONAL DAY OF DONATION OF BREAST MILK.

4. Brazilian HMB in numbers Page 4 Brief description ANVISA (Regulated Agency) In Brazil, all human milk given to babies of women that is not the biological mother should be processed according to standard operating of human milk banks - RDC / Anvisa No. 171/2006. In 2011 Brazil achieved the total of the211 HMB and 114 PCLH (Milk collect post) in all Brazilian states. These PCLH collect the milk and send it to the HMB to be processed. The many of these HMB are collocated in hospitals to offer the milk to Neonatal units. In 2011 the Brazilian HMB collected 168,054 L from 160,022 donors. The volume distributed (129,342) attended 160.666 receptors

5. Page 5 State Group Care Individual Care Home visit Distrito 73.783161.308 29.475 Goiás 6.95021.7134.798 Mato Grosso 8325.103 894 Mato G do Sul 8.39527.7808.831 Alagoas 17.43818.3372.970 Bahia 11.08226.2748.382 Ceará 7.66918.8091.548 Maranhão 5.80522.2344.237 Paraíba 10.89965.2098.565 Pernambuco 8.665156.544 1.682 Piauí 1.1911.5445.745 Rio G do Norte 9.14020.4794.519 Sergipe 9.95016.7182.573 Acre 2.26817.145 616 Amapá 8.67916.990 3.162 Amazonas 10.9553.478 3.838 Pará 4.84726.83415.054 Rondônia 3.77622.520 2.245 Roraima 7.1278.470 1.234 Tocantins 3.62819.050 3.351 Espírito Santo 2.62217.821 2.324 Minas Gerais 8.03942.183 17.426 Rio de Janeiro 9.560107.206 6.131 São Paulo 58.318265.933 60.823 Paraná 11.48015.368 22.440 Rio G do Sul 5.50153.439 604 Santa Catarina 13.06555.900 7.526 Total Brasil 321.664 1.234.389 230.993

6. National and Regional Reference Centers Organogram Chief of Reference Center Teaching Center Laboratory of Quality Control Firefighters Program IT Cluster R&D Center Donor Assistance Production Service – HM Program for Tech Development

7. Transport of Milk The health professional that attend the women in hospital advised the women to seek the milk bank by a toll free number (1-800) where women report that they want to donate the milk. The milk home collection is done through civil defense or fire stations in partnership with milk bank that goes to the home of donors who can not come to the hospital. The milk is transported in isothermal boxes with ice frozen out and arrives frozen in milk bank. Figure 2 shows the car used for civil defense to visit the home donors and collect the frozen human milk. Figure 3 - Isothermal boxes used in the process of collection and transportation of breast milk

8. Who can Receive the Donated Milk 1 - Distribution Distribution of human milk to a receiver is conditional upon: a) the prescription or requesting physician or nutritionist containing volume / daily schedule and needs of the recipient; b) meeting the following priority criteria: b.1) newborn premature or low birth weight that does not suck; infected newborn, especially with enteroinfections; b.2) newborn nutrition trophic; b.3) newborn suffering from immunodeficiency; b.4) newborn suffering from allergies heterologous proteins, and exceptional cases, the medical criteria.

9. Pasteurization LTLT (62 o C for 30 minutes) If the acidity is higher than 8 degrees Dornic the milk is discarded and can not be used for infant feeding. Figura 5 - Creamatocrit and small titrator used to calculate the fat content and Dornic acidity, respectively. Figura 4 - Water Bath for pasteurization process

10. Equipment/Location All the human milk banks follow the modus operandi and the quality standard set by Fiocruz. The reference center cost around US$ 50K Figure 6 – Quality control laboratory of the HMB

11. 11 Table 1 – Quality control laboratory of the HMB