Mapping Processes of Human M ilk B anking

1. Mapping Processes of Human Milk Banking

2. Staffing • FTE • Executive director/Manager • Medical director • Coordinator • Counsellor • Processing clerk/technician • Nutritionist • Nurse/Midwife • Staff sister • Shippers/Receivers • Part time/volunteer • Treasurer • Chairperson (marketing, fundraising, etc.) • Bookkeeper • Doctor/Medical officer • Advisory committee

3. Donor recruitment • Mothers in NICU or Neonatal Unit • Antenatal clinics • Postnatal wards • Infant immunization clinics • Women's groups • Nurses in the hospitals, clinics and IBCLCs • Lactation consultants • Local community outreach • Open days/talks presentations to interested groups • Print media: Pamphlets, posters distributed to recipient hospitals, clinics, birth educators, doctors rooms, mothering groups, selected shops and libraries. • Mass media: Radio, TV, Print media • Electronic media: Website, Facebook, Twitter, email newsletters Marketing essential as demand always exceeds supplies and HIV rate at hospital 25% Advertising is not required. National publicity via the media and social network sites has made advertising unnecessary.

4. Donor screening • Lifestyle/health screening tool (custom or based on blood donor screening) • Self administered detailed health questionnaire (Post, email, online) • Telephone or face to face interviews • Serology test • HIV, Hep B, Syphilis • Blood test results from medical history during pregnancy • Ongoing screening via health declaration made with each donation • BMI • Hb • Consult with healthcare providers • Medication review by pharmacist and medical director • Final approval by medical director

5. Recipient eligibility and screening • Donor milk is only supplied when prescribed by medical officer • Consent of the mother • Preterm less or equal to 30 weeks • When mothers have insufficient supply, severe maternal illness or absence • Premature and newborn infants of low birth weight that do not suck • Babies <1,500g or <1,800g • HIV exposed premature babies whose mothers have chosen to exclusively breastfeed • Babies with tummy trouble or NEC • Post surgery • Consistently absent or reversed end diastolic flow • Haemodynamicall unstable babies who have received inotropic support • Newborns with NEC, immune deficiency; protracted diarrhea; allergy sufferers will heterologous protein and other exceptional cases at the doctor's discretion.

6. Handling and storage of donor milk • Donors provided with verbal information and written pamphlets on labeling, hygiene, storage and transport. • Donors deliver their 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. • Mothers given sterile glass bottle into which to express breast milk. Before expressing mothers wash hands and wipe breasts down with antibacterial swab. • Once milk is expressed mothers record donor number and date of expression on bottle. • Milk is given to breast milk bank manager who immediately pasteurizes it and after cooling freezes it or it can be placed in fridge for immediate use. If she is too busy to pasteurize immediately, milk is frozen for later pasteurization. • The milk is then send to HMB in the Hospital for recording the details • When donation open to environment – under laminar flow cabinet • Appropriate PPE to protect product from staff • All processing steps are done under sterile conditions in Milk Kitchen.

7. Handling and storage of donor milk • If in mother's home she is required to monitor and record freezer temperature • If stored in a hospital in monitored freezer • In milk bank: stored according to the stage in the milk banking process ie raw milk is stored separately from pasteurized milk, screened milk is separate from unscreened milk. All milk is stored separately according to the donor in demarcated and labeled baskets. • Defrosted in fridge overnight. • Warmed-up milk to be used same day, or disposed of. • Breast Milk is safe for four to six hrs at room temperature i.e.- 15 to 25 deg centigrade. • Milk for use allowed to warm up on bench • Thawed refrigerated milk is safe for 24 hours. • Fresh milk can be stored in the refrigerator for five to seven days • In the deep freezer at -20 deg centigrade for six months. • Screened milk kept in freezer compartment for max. 3 months. • Storage at -20C for 3 months pre pasteurization – 3 months post pasteurization

8. Transport of milk • Milk delivered to and collected from depots in cooler boxes with ice bricks, by mothers and staff. • Recipients hospitals responsible for PDEBM collection. We provide cooler boxes and ice bricks if any driver collects without. • Use thick walled polystyrene containers sold for the purpose and with detachable outer carrying case. • Done using vaccine carriers • Via medical couriers • Via ‘Blood Bikes’ (service operated by well trained volunteers) • Milk is transported via overnight express shipments, • Donors and recipients may come to the milk banks to deliver or pick-up the milk. • Only local transport with hospital courier required • Recipient hospitals receive written Guidelines and sign a Memorandum of Understanding accepting responsibility from time of collection. • Agreement among banks in internal document regarding distribution of milk among banks for hospitals.

9. Pasteurization • Pasteurized using Holder Method • Automated • Manual (Water bath) • Flash heat • Purpose designed and built human milk pasteurizers (fully automated) with built in printer and in built milk cooling system. • Single Bottle Pasteurizer; • Pasteurize in 50ml and 100ml aliquots to prevent wastage. • Sealed and capped. • Place the vials containing milk to be pasteurized (with lid semi-closed) • Start timing of pasteurization according to curve pasteurization, agitating the vials and noting the time every 5 minutes. • Pasteurization done at 60 degrees. • Pasteurization is done at 62.5*Cfor 30 minutes after the time of preheating. • By Shaker Bath method the containers are in shaker for 30 minutes on reaching the temperature of 66 °C.

10. 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 pasteurizing 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.

11. Tracking and record keeping • Each pasteurization has batch number, temperature logging on phone screen and can be relayed to remote server. • Each pasteurization has batch number, temperature logging on computer • Combination of electronic and paper. Use Excel spreadsheets to maintain records and to audit activity • Tracking N/A. • As per Guidelines all steps must be tracked and records maintained for 21 years. • A mock recall in each member bank is required every three years. • Various data base and bar coding systems are used among milk banks. We still maintain processing, donor and recipient data on hard copy as well. • Full traceability from every donation to every bottle dispensed to recipients – currently transitioning from full manual paper based record keeping to software ‘solution’ • Records kept indefinitely (local requirement)

12. Assessing milk quality and safety (Pre-pasteurization) • Micro results indicate type of organism and quantity, if found. • The microbiological quality of the milk is made by analyzing microbial inoculation of milk samples in solution of brilliant green bile broth. • Tested either by standard pour plate method or streak method by hospital or Public Health Lab. • Every pool of milk (500 – 800mls, single donor only) is tested pre pasteurization • A few milk banks test the raw samples for Bacillus, Staph A and MRSA. • 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

13. Assessing milk quality and safety (Post-pasteurization) • Regular cultures are done of each and every sample collected. • After they are opened 5 Ml of samples from each of these milk containers are put in the sterile Test Tubes. Then they are sent for testing in the Microbiology lab for culture test. • One sample taken from each donor batch post pasteurization of ± 1 liter or less. • Micro assays on post pasteurization sample – one random sample per batch and each new donor has first sample assayed. • Post pasteurization, sample from every batch should be <100cfu’s per ml. • Post pasteurization results must be <1 CFU/mL in order to be considered for distribution. • 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 • At present the nutritional content of our milk is not assessed • Minority of banks are monitoring nutritional contents of milk. • Towards nutritional analysis and ‘lactoengineering’ (long term goal)

14. Quality assurance • We provide donors with sterile containers. Containers are capped with tamper proof seals prior to pasteurization. • Head quarters staff oversee and do actual processing at odd intervals. Potential improvements are discussed and implemented if deemed necessary. • Swabs taken from pasteurizer 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. • Pasteurizing temperature monitored and recorded. • Temperature control of freezers; temperature monitoring of pasteurizing and cooling; batch numbers and donor number on each bottle; expiry date on each bottle

15. Qualityassurance • HACCP • Audit of implementation of NICE guideline • Double checking and authorization of all test results • Annual calibration of equipment and follow maintenance schedule • Quality assurance is made ​​according to the following parameters: Dornic acidity, off-flavor, dirt, color and presence of coliforms. • Accredited microbiology laboratory and ISO-Certified NICU present. • HACPP guidelines, recall and tracking systems in place to report negative findings, mandatory HMBANA Guidelines updated annually, certification annually, some states have tissue banking requirements for milk banks, Experts involved from FDA, CDC, Health Canada to upgrade standards, advisory committees, annual Board of Director meetings of HMBANA • Code of Good Manufacturing Practice (Blood and Tissues) developed by TGA. Incorporates our SOP’s and HACCP.