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2d-Audit cover

This template was developed to help human milk banks (HMBs) self-evaluate their standard operating procedures (SOPs), staffing, equipment, and infrastructure. This quality assurance template covers SOPs present in HMBs and can be utilized by all developing and existing HMBs.

This template covers the entire milk banking process from donor recruitment, donor screening, milk expression, milk handling, milk processing, and allocation to recipient prioritization and staff training. Staffing, infrastructure, equipment, record keeping, and documentation recommendations are also presented.

Every HMB carries out numerous and complex processes. HMBs must align with the resources and needs of their community, and each country should decide how to best utilize available resources to help guarantee the safety and quality of their donor human milk (DHM). Accordingly, specific protocols in HMBs can vary due to the diversity of resources, disease risks, and cultures. International human milk banking guidelines that outline precise operating processes and requirements present in every milk bank are thus neither feasible nor appropriate. The guidelines presented in this template are based on SOPs from many milk banks globally.

This template was developed to help HMBs identify differences and possible gaps in their SOPs, with the ultimate goal of improving and protecting the quality and safety of the DHM they produce. This template creates a starting point for HMBs to evaluate their own procedures and raises awareness that milk banks need to evaluate their procedures and facility, requiring both internal and external auditing. As such, HMBs must have written SOPs and facility manuals, formal training on SOPs, and record keeping instructions, based on established quality and management systems, in place to properly utilize this template and perform an audit. There is currently no international organization, and often countries do not have national organizations, to enforce external or internal audits. External audits are more feasible in countries with the resources for enforcement, such as in countries where HMBs are authorized and monitored by the ministry of health. Ideally, both external and internal audits are conducted on a regular basis to identify problems before milk safety and quality is affected.

This template can be used to help guide changes in SOPs, but it does not provide a specific or step-by-step prescription on how to improve SOPs as there can be many reasons for variations. If your HMB’s process steps do not align with the SOPs presented, we recommend using your national guidelines on human milk banking and the resources listed in PATH’s Strengthening Human Milk Banking: A Resource Toolkit for Establishing and Integrating Human Milk Bank Programs—A Global Implementation Framework to help improve and protect the quality and safety of the DHM your facility produces.

This template WILL:

  • Provide a starting point for HMBs to self-evaluate their operating procedures.
  • Guide HMBs in self-evaluating their SOPs.
  • Help HMBs identify gaps in their SOPs.
  • Help outline SOPs present in many HMBs.

This template WILL NOT:

  • Provide mandatory international guidelines for SOPs.
  • Provide a comprehensive list of guidelines for every HMB.
  • Evaluate the compliance or grade the performance of HMBs based on specific requirements.
  • Provide specific instructions on how to improve upon site-specific guidelines.