This is an old revision of the document!
Instructions are in blockquotes like this.
Labs Github repo located here
We are working to address 2 problems:
There is currently a major donor milk shortage. 80 million ounces a year are needed to feed all the neonatal babies in the United States, but only about 15 million ounces are used. (reference?)
This has particular impact in hospitals' Neonatal Intensive Care Units (NICU), where use of “formula” can have fatal impact (necrotizing enterocolitis) on a premature baby's intestines, leaving human milk to be the only viable option.
At a global scale, donor milk fraud and lack of traceability are known issues - human milk can sell from anywhere between $4 and $16 an ounce.
“In 2015, a team of researchers who purchased breast milk on the open market reported in the journal Pediatrics that about 10 percent of samples contained cow’s milk, which could have been added by the sellers to increase volume and thus the size of the payment. The same team had reported in 2013 that milk purchased online was frequently contaminated by pathogenic bacteria.” - The appetite for breast milk has produced a growing commodity market (link below)
While there are smaller entities engaging in the space, there is no large-scale breast milk providers and there is opportunity to expand participation from donors and accessibility for babies in need.
Please explain the business problem or opportunity in business terms without technical jargon, and without mention of a distributed ledger.
Rapid Healthcare has a production level application to track provenience of mothers milk & human fortified donor milk, the solutions help reduce mis-feeds as well as track enrollment, quantity and mobile labeling of milk products for NICU babies called Mother's Milk. This is not a blockchain based solution, and is looking to provide a global good solution to provide transparency and traceability to the donor milk process in the first mile.
Rapid Healthcare is also in conversations with Apple Healthcare on how they could leverage their work in Patient Medical Record management to move this work forward: https://support.apple.com/en-us/HT208647
Prolacta is a private milk bank that provides standardized human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU)
Non profit milk banks also participate in this work and there is the Human Milk Banking Association of North America (HMBANA)
If there are systems in place today which automate the above business problem/opportunity, please explain what exists.
A DLT solution in this case would improve on the current solution for the following reasons:
Please explain how distributed ledger technology would improve the current solutions (if they exist) or enable new solutions which were previously unavailable. The goal here is to ensure we do not have a solution looking for problems, but problems where solutions would become possible or significantly improved by using distributed ledger technology.
Give the shortage of supply and the vulnerable population that donor milk supports, any tool that can help increase supply, access, and traceability without adding significant cost is a win for the sector.
It is challenging for donors and prospective recipients to verifying details surrounding the entire process. This creates a market where donors may be resistant to donate and recipients are skeptical of the process to deliver quality milk. These high costs make it a challenge to create a system that is economical considering the need to provide breast milk to babies who are often in impoverished areas of the world.
The major need that the build fills is: allowing individuals/entities which today track status of donor milk in different “data silos”/separate donor banks to have a wider view of a “global” donor milk supply chain through the decentralized sharing of chain-of-custody/transfer/track movement/requests data amongst participants. - (?)and this is applicable in a variety of use cases in sourcing of vaccines and treatments (?)
Use this section to give details that support the value of pursuing these user stories using distributed ledger technology. Some examples of information that might be included here are applicable market segments, workloads, user bases, etc. and any associated data.
Targeting a POC in time for the Hyperledger Global Forum
We are also currently working on a submission for the AsiaPac HIMSS: Donor Milk AsiaPac HIMSS Application
Diagrammed here: happy_path_mpv_flow_for_donor_milk.pptx
Additional scenarios to be addressed once MVP is completed
Using Hyperledger Composer, Angela has created code. In summary the features of the network are:
Parameters - What parameters are we looking for inputs and participants?
SME Questions and Responses
• What are the major challenges that donor banks are facing in regard to supply/demand visibility and transparency? ○ Hospitals have contracts with milk banks and hospitals might have multiple contracts ○ If milk bank NE cannot complete contract they reach out to other banks § Works in 2 ways □ Raw milk between donors □ Email is method for fulfilling contracts • What legal/regulatory standards are you working with and what does the paperwork load look like to meet these requirements? • How is collaboration between Non-Profit, For Profit and COOP entities in the space? • Do you engage at an international level with other donor organizations?
• How do you communicate your supply to hospitals and decide where your donations go? • What are the specific issues that drive the supply chain? • What data are already being collected by your systems for the donations and movement of the them? With the creation of a network what is a list of key attributes she would like to have inside the network on the traders and the milk samples. What is important for her group to be able to query from the network?
• Are there challenges with physically storing the milk in a secure manner? Is someone trying to make changes to the milk a risk? ○ Freezers are secured ○ FedEx or couriers ○ If there are delays the milk is replaced ○ No history of adulteration ○ Bottles are tamper evident • What actions are taken when contamination is detected? ○ 2 data bases that track pool # and batch # ○ Mock recalls happen every couple of months § Need to be traced back within a couple of hours § Might be reported to local and national authorities • Quality assurance ○ Detailed screening of donors modeled after blood banks 3-4 step process § Establishing relationship donor § Packed for sign off for mother's physician § Bank can accept the § Data tracked in DB and paper based ○ Pasteurization of the milk - and processes § Milk is pooled
Please explain this use case using actors and interactions and assuming the ideal distributed ledger technology exists. You can tell one or more user stories if they are inter-related.
Please list requirements per user story.
It would be useful to explain where the use of the distributed ledger begins. For example, in a use case for prescription drugs, it would be valuable to ensure: * The manufacturer has sourced the correct ingredients * The manufacturer has combined the ingredients correctly * The manufacturer has tested the finished product and recorded the results for later audit * The finished goods are tracked to ensure the end user received exactly what the manufacturer shipped However, these could all be different use cases addressed with different solutions. So, it's important to explain where the problem starts and where distributed ledger technology would help.
It is useful to specify requirements that should be considered but may not be apparent through the user story and usage examples. This information will help the developers be aware of any additional known constraints that need to be met for adoption of the newly implemented features/functionality. Precise specifications of the requirements make a developer's job much easier, so when in doubt, consult a technical expert.
Example of the requirements not obvious thru user stories: performance, hardware, connectivity, privacy etc.
Workflow provided by Anton and Ron on 7/30 for review by the Group:
PPT that includes the workflow but provides additional context on why a blockchain solutions and steps to get there: PPT deck from Anton and Ron
Key facts and evidence base
Root cause analysis
Counterfeit risk and regulation
Related News Stories
Please use this section to add references for standards or well-defined mechanisms. In particular, if any of your requirements specifically call for the implementation of a standard or protocol or other well-defined mechanism, use this section to list them.
Additionally, if your use case needs non-standard consensus mechanisms or cryptographic tools, please include technical material here, or references to technical material (i.e. a link to an eprint paper with security proofs). Remember, the burden of proof for security or consensus of non-standard mechanisms will be placed upon the proposer rather than the evaluator of the proposal, so be verbose here if necessary.
It is highly suggested that you define any terms, abbreviations that are not commonly used in order to ensure that your user story is understood properly.
Provide a list of acronyms, their expansions, and what they actually mean in general language here. Define any terms that are specific to your problem domain. If there are devices, appliances, or software stacks that you expect to
interact with Hyperledger, list them here.
Acknowledgement: This is very loosely based on the OpenStack use case template
Guidelines are available for purchase Here
Defines a variety of terms used in the chain of custody for the donated milk.
Each HMBANA bank has
All banks must comply with privacy and confidentiality rules at the federal and state/providence (i.e. HIPAA in the US or HIA in Canada)
Donors are healthy lactating women that have been
verify that no medications they are taking are grounds for exclusion - donor are deferred indefinitely for any positive results on a diagnostic/confirmatory serological test
Exclusion criteria include a variety of items that are somewhat similar to what you might find for blood donation
Temporary disqualification may also occur for certain medications, vaccinations or other activities
If a donor tests positive for any diagnostic or sterological test - they are referred to a medical provider of the donor's choice and any milk already collected is disposed of
Donors are encouraged to communicate with milk banks if any aspects of their health change, and the bank is required to document communication with donors at a minimum every 2 months
To ensure safety and quality of donated milk, donors are instructed in proper methods for milk collection, handling, storage and transportation
Donors are given written instructions covering
If the milk was collected before the individual was registered as a donor the screening process will include information gathering around how the milk was collected, stored, and any medications or supplements the donor was taking during the time of collection
A detailed procedures manual is available to all milk bank personnel at all times and is reviewed annual and signed by the medical director or other qualified staff
While not required, if bar-coding of milk is done the request is that manufacturers directions be followed, that the bank report out to recipient hospitals about the type they are using, and ideally use the same type as the hospital
The bank holds a variety of records for the following groups
Annual statistics are sent to HMBANA and published in the annual report
While the bank accepts responsibility for screening, processing, and distribution of milk, the depots are agencies affiliated with the banks for collecting and storing the milk that is then transported to the milk bank for processing. The guideline provides information for depot:
Affiliate bank is responsible for depot compliance with guidelines and must indicate compliance via written or verbal confirmation
A donor milk distribution site is a facility that has contracted with a milk bank to carry a supply of donor milk to where it is distributed to receivers of the milk. The donor bank is responsible for certifying compliance of the Distribution sites on an annual basis guidelines include stipulations around
The distribution center has to demonstrate records upon request of the bank.
A system of tracking donor milk from donor to recipient is maintained
Interview on 9/27: NICU Lactation Conultant
• Pam is a NICU lactation consultant at one of the largest healthcare facility within a healthcare system that has over 900 facilities • She is specialized due to the size of the facility with NICU lactation consultants and in-patient lactation consultants being distinct roles; her focus is on mother's milk, not donor milk • At smaller facilities, lactation consultant responsibilities includes management of donor milk as well as mother's milk • Pam has offered to take an advisory role moving forward, and she is going to refer us to the dietician that manages the donor milk in the facility • As a NICU lactation consultant, if a mother's supply is good and might expire or if there has been an infant loss, they offer donation as an option ○ They refer mothers to WakeMed Donor Bank and they have fliers that they pass along ○ They do not do donation collection within the facility • If a baby or mother is transferred to another facility within the healthcare system, the mother's milk has to be relabeled facility to facility - an opportunity to standardize the labeling across the full healthcare system • When Mother's bring in their milk for their baby in the NICU, there are kiosks where the mothers can check in the milk; they use a barcode labeling system • Expiration of milk ○ In the NICU in deep freezers milk can hold up to 6 months ○ At home in deep freezers the recommendation is 6-12 months • Donor milk is the responsibility of the dietician on staff who manages the supply with donor banks and the milk preparation onsite ○ There is informal sharing of donated milk across facilitates within the healthcare system and visibility on supply could be better - an opportunity to improve the donor milk network between facilities within the same system
Interview on 10/31 with dietitian responsible for all NICU feeding (including donor milk) for major hospital