Human Milk Bank Processes: YOUR FACILITY AND LOCATION Louise Goosen Chairperson Milk Matters

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Background info Page 3 Brief description How did your human milk bank (HMB) began? When? Prof Anna Coutsoudis visited Cape Town in Oct 2002 to present the idea of starting milk banks to supply DEBM to HIV infected orphans. A group from the audience took on the challenge and Milk Matters emerged. Who provided initial funding? How are ongoing operations funded? Integrated into government services? Prof Anna Coutsoudis sourced our initial funding from UNISEF. Staffed by volunteers Milk Matters supplied milk at no charge until By then we had employed a coordinator, were registered as a NPO and PBO but funding was sporadic. We were forced to introduce a processing fee. Our private public partnership includes sponsorship from a private Pathology Laboratory as well as ‘sponsorship’ from the National Health Laboratory Services for our micro testing. Income is derived from our processing fee which is partially sponsored by the 2 laboratories, which enables us to pay the 4 salaries. We are also based at a government hospital and have a contract that supports this mutually beneficial arrangement. Besides this contract and the fact that the bulk of our DEBM is used by government hospitals we are not integrated into the state hospital services. Who regulates /oversees HMB in your country/region (if any)? At present there are no official HMB regulations in SA. The HMB’s in SA participated in setting up our own HMBASA guidelines. Our government and some provinces are in the process of setting up regulations.

Background info Page 4 Brief description How many HMBs are part of your system? Where are they? At present Milk Matters operates in the WC Province where we have assisted in the setting up of 3 self-sufficient and 3 milk banks that process some of their own DEBM. The furthest is 300 km away but the majority are within a 20 km radios. We have also assisted Limpopo Province in setting up their own system. Our latest invite was from Malawi, who we will be visiting in Feb Is there a central HMB that processes milk and distributes or many HMBs that process milk and distribute? (Centralized vs de- centralized) We are more centralized but working hard at decentralizing the system. How many NICU/Neonatal wards/community homes does each bank serve? Are they collocated? We supply the shortfall of the 3 hospitals that process some of their DEBM as well as 20 other hospitals NICU. They are spread in and around Cape Town. How many babies does your facility/system serve annually? Approximately 15,000 premature babies, excluding the 3 self-sufficient milk banks. How many liters/year does your facility/system process annually? 1,500 liters at our head quarters, excluding our associated milk banks How many donor mothers initiate donation to your facility/system annually? Over the past year just over 200 to our head quarters, excluding donations to our associated milk banks.

Process Brief description of processes Staffing Paid staff x 4 - work maximum of 30hr/week: 1 x Secretary/manager (IBCLC) 2 x Coordinators (Assist secretary/manager) 1 x Processing clerk Volunteers x 3, all IBCLC's: 1 x Treasurer 1 x District coordinator 1 x Chairperson (Marketing, Fundraising etc.) Contract bookkeeper x 1 Donor recruitment Within the hospital where we are located, mainly from mothers whose babies are in neonatal or the KMC unit. Marketing essential as demand always exceeds supplies and HIV rate at hospital 25%. SA's exclusive BF rate 8% at 6 months: - Pamphlets, posters distributed to recipient hospitals, clinics, birth educators, doctors rooms, mothering groups, selected shops and libraries. - Radio, TV, print media. - Electronic media – Website, Face book, Twitter and Newsletter. - Open days, talks/presentations to interested groups and at conferences. Donor screening Lifestyle/Health Screening tool. HIV and Hep B Screening. Recipient eligibility and selection Babies weighing less than 1,500 gr. HIV exposed premature babies whose mothers have chosen to exclusively breastfeed. Babies with tummy trouble or NEC. Post surgery babies. AND Mothers have insufficient, while building up their own supply, severe maternal illness or are while absent (most often due to social circumstances) AND DEBM is only supplied when prescribed by MO. Must be re-prescribed every 2 weeks.

Process Brief description of process Handling and storage of donor milk (from donation to feeding) Donors provided with verbal and pamphlets information on labeling, hygiene, storage and transport. Decanted into specified quantities including a sample from each batch for micro testing. Only milk from single donor is ever pooled. Sealed and capped. Labeled with donor and batch numbers, pasteurisation date and time. Refrozen post pasteurization and chilling. Once micro results become available the DEBM can be distributed. Recipient NICU’s are responsible for collecting and maintaining the cold chain. We provide guidelines for transport, storage, defrosting and timelines at room temperature. Transport of milk Donors deliver frozen DEBM to ‘depots’ or is collected from their homes – cooler boxes. Collected from depots and stored in freezers until sorted and batched for processing. Defrosted in fridge overnight. Recipient hospitals are responsible for collecting DEBM from our head quarters. We provide cooler boxes and ice bricks if any driver collects without. Recipient hospitals receive storage guidelines and sign a Memorandum of Understanding accepting responsibility from time of collection. Pasteurization All processing steps are done under sterile conditions in Milk Kitchen. Pasteurised using Holder Method.

Process Brief description of process Tracking and record keeping Database, includes Donor and batch number, contact details, dates of baby’s birth, blood tests, first and last donation, quantities donated, recipient hospital and how donor learnt about Milk Matters. Records kept of Screening forms, Consent to HIV and Hep B testing, donor pathology tests results and DEBM micro results. Records kept of donor numbers, batches and quantities processed daily. Records kept of pasteurising temperatures, fridges and freezers. Records of recipient hospitals and babies (if known), donor numbers and batches collected and signed for by recipient hospital drivers. All DEBM released can be back tracked to donor, test results and processing records. Assessing milk quality and safety (ie. microbiology assays) One sample taken from each donor batch of ± 1 liter or less, post pasteurization. Milk is only pooled if odd containers (not Milk Matters’) have been used. Milk may only be released once micro results are available. Micro results indicate type of organism and quantity, if found. At present the nutritional content of our milk is not assessed, although we have the equipment at hand. Quality assurance We provide donors with sterile containers. Containers are capped with tamper proof seals prior to pasteurisation. Head quarters staff oversee and do actual processing at odd intervals. Potential improvements are discussed and implemented if deemed necessary. Swabs taken from pasteuriser at random intervals. Swabs taken from other areas in Milk kitchen at random intervals. Visited by advisory team from Microbiology laboratory and implemented their suggestions. Pasteurising temperature monitored and recorded.

Equipment/Location Brief description of process What is used/how many? Pasteurizer – One, awaiting second. Freezers (lockable?) – 4 in Milk Kitchen / headquarters and 5 at various depots. The main ones are lockable. Freezer for mothers’ own EBM – highly recommended. Refrigerators – Have access to Milk Kitchen fridges. Additional HMB equipment requirements? Computers – x2 Other – printer/copier, label printer, capper, Tiny Tagg, phones, internet access, DEBM containers. Referral/feeder/depot facilities? 12 depots keep supply of sterile containers. We supply the busier depots with freezers. Others use their own. Neonatal ward equipment requirements? System for tracking usage? – With baby’s records Freezer – Not essential for DEBM if daily requirements prepared in Milk Kitchen. Highly recommended for mothers’ own excess EBM as potential DEBM. Fridges – essential for EBM and DEBM. Other? Fortifiers added at bedside? Sachets not readily available. Use of fortifiers not routine in all hospitals.

Organizational Successes Page 9 Brief description of top 3-5 successes Policy Tshwane Declaration Aug 2011 stated national and regional support for breastfeeding and milk banking. National and regional policies are being developed. Accepted as local government’s official advisors on Milk Banking. Have helped develop Provincial Guidelines on storage of EBM. Operational When they receive the extra support and motivation the majority of our ‘recipient’ mothers go home breastfeeding their own babies. A number of donors have breastfed their own babies for longer periods because they wanted to continue donating. Technology Improving / updating our donor milk screening, processing techniques, record keeping and equipment is ongoing.

Organizational Challenges Page 10 Brief description of top 3-5 challenges Policy No visible progress has been made on policy or promotion of breastfeeding at National or Provincial Government level in spite of Tshwane Declaration 15 months ago. Financial support not forthcoming, National and Provincial Government is depending on the goodwill of enthusiasts. Consequently being able to expand the organisation i.e. our donor base is our biggest challenge. Operational Depending on volunteers is not sustainable. The biggest threat to our organisation is a lack of funds for staff salaries. The biggest hurdle to starting up new milk banks is finding enthusiasts, at that facility, who are willing to take on the extra work load without being reimbursed for it. Technology The 3 large NICU’s that we supply use 1 to 2 liters sometimes more per day. Their DEBM is pasteurised and distributes in quantities of 200ml. To minimize wastage in other NICU’s, we also have batches available in 100ml and 50ml quantities. Similar volumes are pasteurized together.