“ANALYSIS OF EFFICIENCY AND EFFICACY OF THE SALVADORAN NETWORK OF HUMAN MILK BANKS” Acknowledgments Authorities Ministry of Health Dr. Francisco José Alabí Montoya, Minister of Health (Ad-Honorem). Dr. Carlos Gabriel Alvarenga Cardoza, Deputy Minister of Health Management and Development. (Ad-Honorem) Dr. Karla Marina Díaz de Naves, Deputy Minister of Health Operations. Editorial Committee MINSAL Dr. Juan Morales. Coordinator of the Unit of Integral Attention to Children. Dr. Mirian Alvarado, Coordinator of the Salvadoran Network of Human Milk Banks. CALMA Ana Josefa Blanco Noyola, Executive Director. Kenny Marielos García de López, Coordinator of the Breastfeeding Unit. Lic. John Cativo, Management and Monitoring Manager. Flor Artiga de Bolaños, Communications Coordinator. Consultant Ernesto Nosthas, Lead Researcher. To the staff of the Salvadoran Network of Human Milk Banks interviewed for this study: Human Milk Banks of the National Women's Hospitals "Dra. María Isabel Rodríguez", "San Juan de Dios" of San Miguel, "San Juan de Dios" of Santa Ana and the HMCC: Hospital Nacional de Zacatecoluca, Hospital Nacional de Usulután, Hospital Nacional de San Francisco Gotera, UCSF de La Presita - San Miguel, UCSF Puerto de La Libertad, UCSF Los Planes de Renderos, UCSF San Martín, UCSF Unicentro-Soyapango, San Julián Integral Center for Maternal and Child Care and Nutrition CIAMIN, Manufacturing Companies Fruit of the Loom Santa Ana & Ciudad Arce, ISSS Santa Ana Regional Hospital, Hospital Nacional de Chalchuapa and Hospital Nacional de Ahuachapán. To the donor and recipient mothers of the HMB who provided information. I Content Acknowledgments .............................................................................................................................................................................. i Index of tables and figures ............................................................................................................................................................. iv Acronyms and abbreviations ......................................................................................................................................................... vi 1. Introduction...............................................................................................................................................................................1 2. Objectives of the Study ..........................................................................................................................................................1 3. Rationale of the Study .............................................................................................................................................................2 4. Methodological Approach ......................................................................................................................................................4 5. Conceptual framework ...........................................................................................................................................................5 Human Milk Banks and Collection Centers ...........................................................................................................................5 Efficiency analysis ..........................................................................................................................................................................8 Analysis of key factors for improvement in the operation of the HMB-HMCC network. ...................................... 11 6. Findings of the HMB-HMCC Network Efficiency Analysis ........................................................................................ 12 Phase Zero: Donor Mother Recruitment............................................................................................................................ 12 Phase 1: Collection of DBM .................................................................................................................................................... 16 Phase II Processing of DBM to obtain PBM......................................................................................................................... 20 Phase III Dosage of PBM .......................................................................................................................................................... 22 Installed capacity utilization ..................................................................................................................................................... 24 PBM production performance factor .................................................................................................................................... 26 Pasteurized breast milk production line capacity............................................................................................................... 27 Coverage of the demand for pasteurized breastmilk ....................................................................................................... 29 7. Analysis of improvement factors to optimize the operation...................................................................................... 30 Recruitment of donor mothers.............................................................................................................................................. 30 Human Resources ..................................................................................................................................................................... 31 HMB Human Resources ...................................................................................................................................................... 31 Human resources at HMCC .............................................................................................................................................. 32 Infrastructure .............................................................................................................................................................................. 36 HMB Infrastructure............................................................................................................................................................... 36 HMCC Infrastructure ............................................................................................................................................................... 36 Equipment .................................................................................................................................................................................... 37 HMCC equipment................................................................................................................................................................. 37 HMCC Freezers .................................................................................................................................................................... 37 Transportation at HMB - HMCC ...................................................................................................................................... 38 II Inventory and Control Systems at HMB - HMCC ........................................................................................................ 39 Cross-cutting aspects of the HMB-HMCC Network ....................................................................................................... 40 The quality of the processes .............................................................................................................................................. 40 Monitoring and evaluation .................................................................................................................................................. 40 Coordination between units .............................................................................................................................................. 40 Overall Weighting of Key Operating Factors ..................................................................................................................... 41 8. HMB Network Cost Analysis ............................................................................................................................................ 43 9. Key Findings from the HMB Network Donor Mother Perceptions Survey ........................................................... 44 10. Conclusions........................................................................................................................................................................ 45 On the recruitment of donor mothers (Phase 0):............................................................................................................. 45 DBM Over-Capture (Phase 1):............................................................................................................................................... 45 On PBM production (Phase 2): .............................................................................................................................................. 46 PBM delivery and dosage (Phase 3) ....................................................................................................................................... 47 On Cross-cutting Processes ................................................................................................................................................... 47 11. Lessons learned................................................................................................................................................................. 48 Best practices.............................................................................................................................................................................. 48 Strategic opportunities to enhance the HMB-HMCC Network .................................................................................... 49 12. Recommendations ............................................................................................................................................................ 49 General recommendations ...................................................................................................................................................... 49 On the recruitment of donor mothers (Phase 0):............................................................................................................. 50 Over-capture of DBM (Phase 1): ........................................................................................................................................... 51 On PBM processing (Phase 2): ............................................................................................................................................... 52 PBM Delivery and Dosing (Phase 3)...................................................................................................................................... 52 13. Bibliography........................................................................................................................................................................ 53 III Index of tables and figures Figure 5-1: Chronology of the establishment of the HMB-HMCC network in El Salvador. ...........................................6 Figure 5-2: Territorial network of HMBs and their network of HMCCs. ..........................................................................7 Figure 5-3: PBM production line in the HMB-HMCC Network. ...........................................................................................8 Figure 5-4: Key elements for the HMB-HMCC network efficiency analysis. ......................................................................9 Box 5-1: MINSAL guidelines on home milk collection.......................................................................................................... 10 Table 5-1: Matrix analysis of improvement factors for the operation of the HMB-HMCC network. ..................... 11 Figure 6-1: Structure of raw breast milk inputs to HMBs between June 2020 and July 2021 (liters). ...................... 15 Table 6-1-A: Key aspects that define the operation of the HMCC network attached to HMB San Salvador. ....... 17 Table 6-1-B: Key aspects that define the operation of the HMCC network attached to HMB Santa Ana. ............ 18 Table 6-1-C: Key aspects that define the operation of the HMCC network attached to HMB San Miguel............ 19 Table 6-2: Pasteurized milk production June 2020-July 2021. ............................................................................................. 21 Table 6-3: Abnormal DBM losses in the HMB-HMCC network June 2020 - June 2021. ............................................. 22 Figure 6-2: Historical trends in PBM delivered and babies benefited. ............................................................................... 23 Table 6-4: Statistics on production and delivery of PBM to beneficiary babies at HMB.l año precedente. ............. 24 Table 6-5: Yields by territorial network and type of establishment to which the HMCC is attached. ..................... 25 Table 6-6: Maximum throughput standards at HMBs............................................................................................................ 26 Table 6-7: PBM production yield factor at HMB. ................................................................................................................... 26 Figure 6-3 Pasteurized breastmilk production line capacity ................................................................................................ 28 Table 6-8: Coverage of newborns under 1500 grams at the national level MINSAL. ................................................... 29 Box 7-1 Key operating factor assessment – Recruitment of donor mothers ................................................................. 31 Table 7-1-A: Staff attending the HMCCs visited for the present study in the HMB network of San Salvador: Experience and training courses. ................................................................................................................................................ 33 Table 7-1-B: Staff attending the HMCCs visited for the present study in the HMB network of Santa Ana: Experience and training courses. ...................................................................................................................................................................... 33 Table 7-1-C: Staff attending the HMCCs visited for the present study in the HMB network of San Miguel: Experience and training courses. ................................................................................................................................................ 34 IV Table 7-2: Summary of experience and training courses by HMB territorial network. ................................................ 35 Box 7-2 Key operating factor assessment – Recursos Humanos en los HMCC ............................................................ 35 Box 7-3 Key operating factor assessment – Infraestructura ............................................................................................... 37 Table 7-3: Average years of operation by type of equipment in HMBs (2021). ............................................................. 38 Box 7-4 Key operating factor assessment – HMB Equipment ............................................................................................ 39 Box 7-5 Key operating factor assessment – Cross-cutting aspects of the HMB-HMCC Network........................... 41 Figure 7-1: Key operating factors global assessment of the HMB-HMCC Network..................................................... 42 Table 8-1: Analysis of Total Costs of the HMB Network - HMCC of San Salvador (data collected for June 2020 June 2021) ........................................................................................................................................................................................ 43 Figure 12-1: Basic Structure of an HMB-HMCC Network Monitoring and Evaluation System .................................. 50 V Acronyms and abbreviations ABC Brazilian Cooperation Agency CALMA Breastfeeding Support Center DBM Donated Breast Milk ECN Necrotizing Enterocolitis FOSALUD Solidarity Fund for Health HMB Human Milk Bank HMCC Human Milk Collecting Center ISSS Salvadoran Social Security Institute LM Breastfeeding MDG Millennium Development Goals SDGs Sustainable Development Goals MINSAL Ministry of Health NGO Non-Governmental Organization NICU Neonatal Intensive Care Unit PBM Pasteurized Breast Milk RIIS Comprehensive and Integrated Network of Health Services SIBASI Basic Integral Health Systems SRH Sexual and Reproductive Health UCSF Community Family Health Clinic UNICEF United Nations Children's Fund WHO World Health Organization VI 1. Introduction MINSAL has developed a series of policies and programs based on scientific evidence that have been implemented with the purpose of influencing the reduction of neonatal and infant mortality from these causes, addressing risk factors in women from before conception, among which, one of the most successful and effective has been the creation of the National Network HMB-HMCC . This initiative is being promoted since 2011 under the leadership of MINSAL, with the technical and financial support of the UNICEF and CALMA, a coalition of different institutions such as the Neonatal Alliance of El Salvador and the Government of the Federative Republic of Brazil in the framework of international South-South cooperation agreements and the media. HMB is internationally recognized as a fundamental and decisive strategy to save the lives of children in special conditions. CALMA has been part of this effort since its beginning and is currently the only Civil Society Organization to be a member of the Global Network of Human Milk Banks, being a key partner for MINSAL to strengthen this strategy. This document corresponds to CALMA's inter-institutional work priorities for the year 2021 and is part of the technical assistance efforts to strengthen the HMB-HMCC Network, which is a strategic instrument for the promotion, protection and support of breastfeeding, also establishing (i) a valuable pool of specialized tools for the vital development of the preterm and/or low birth weight neonatal population and (ii) a set of good practices that prevent/address diseases such as neonatal sepsis and necrotizing enterocolitis, which contributes concretely and gradually to the diminution of neonatal mortality (CALMA-UNICEF-MINSAL, 2017). This study has been organized into four sections, the first consists of the general presentation of the objectives, justification, methodology and conceptual framework of the study, the second section presents the results obtained in the analysis of the operation of the HMB-HMCC system in both the analysis of the efficiency with which the network currently operates, the key operating factors. The third section analyzes the impact of the Strategy on donor mothers and their babies through the results of a survey. The final section synthesizes the lessons learned from the study in terms of conclusions, lessons learned, good practices and recommendations to improve the management of the strategy within the framework of the National Policy to Support Early Childhood Development "CRECER JUNTOS (Growing Together)”, the National Policy for the Promotion, Protection and Support of Breastfeeding and the Law for the Promotion, Protection and Support of Breastfeeding and its Regulations. 2. Objectives of the Study The general objective of the study is to systematize and analyze the technical evidence on the Salvadoran Network of Human Milk Banks in El Salvador to establish the efficiency and effectiveness of the operation of HMBs and HMCCs in the period from June 2020 to June 2021. From this general objective, the study was conducted with these specific objectives: i. Analysis of the infrastructure of the three existing HMBs nationwide and a sample of fourteen HMCCs to determine strengths and needs. The study includes information on logistical aspects that affect the transfer of collected human milk from the HMCCs to the HMBs. 1 ii. Analysis of the human resources of HMBs and HMCCs to determine current capacities and identify needs for strengthening. iii. Analysis of the promotion of human milk donation, counseling provided to mothers, recruitment of donor mothers by HMB-HMCC , quantity of milk and conditions for extraction and frequency. iv. Efficiency and effectiveness analysis of the functioning of the HMB Strategy and the current status on: Promotion for human milk donation and recruitment of donor mothers. Collection of human milk at HMCC. Human milk storage at HMCC. Transport logistics from HMCC to HMB. Processes of analysis and discarding of human milk at HMB. Pasteurization process and final delivery of pasteurized milk to low birth weight or premature newborns in Human Milk Banks. 3. Rationale of the Study According to WHO, malnutrition is directly or indirectly responsible for approximately one third of the deaths of children under 5 years of age in Latin America. Well over two-thirds of these deaths, often related to inadequate feeding practices, occur in the first year of life. Nutrition and care during the early years are fundamental to lifelong health and well-being. In infancy, there is no more valuable asset than breastfeeding, yet only 5 out of 10 infants in El Salvador are exclusively breastfed for the first six months. According to Lancet, "Children who are breastfed for longer periods have lower infectious morbidity and mortality, fewer dental malocclusions and higher intelligence than those who are breastfed for shorter periods or are not breastfed. This inequality persists throughout life. There is growing evidence that also suggests that breastfeeding could protect in the future against overweight and diabetes": without exclusive breastfeeding, there are higher probabilities that children face chronic malnutrition (CALMA-UNICEF-MINSAL, 2017). Children suffering from chronic malnutrition not only have short physical stature, but also the development of their brains-their "gray matter infrastructure" is atrophied. Between the third trimester and the third year of life, one million synapses are formed every second, and these connections form the essential brain architecture on which all learning, behavior and health depend. Fewer neural connections are formed in the brain of a malnourished child and these gaps are not recovered (WHO, 2002). Based on the above considerations, breast milk is indisputably the best food for newborns and infants, since it is a safe food par excellence that reduces the risk of diseases such as allergies, diarrhea, respiratory infections, asthma, otitis, meningitis, urinary tract infections, necrotizing enterocolitis in premature infants and sudden infant death. It 2 also favors a quick recovery in case of illness. Scientific studies have shown that it also favors visual and intellectual development (WHO, 2002). For the specialized care of premature infants, WHO recommends that "when the mother's own milk is not available, PBM from selected donor mothers from certified HMBs is the best option for infant feeding, especially in the case of sick or high-risk infants" (WHO, 2002). PBM is the second best feeding option for newborns with special conditions, such as low birth weight or premature infants. This milk needs to be pasteurized to inactivate viruses and bacteria, but at the same time its nutritional composition diminishes. Despite this, like breast milk, it has proven to be beneficial for the preterm neonate as it produces a diminution of enterocolitis, sepsis, bronchopulmonary dysplasia, as well as an increase in food tolerance and better neurodevelopment (Picaud JC, 2017). HMBs are specialized centers responsible for the promotion and support of breastfeeding and the collection, processing, quality control and dispensing of donated mother's milk to any child who needs it, under medical criteria. HMBs are fed by volunteer mothers who donate their surplus breast milk, which are subjected to strict validation and certification protocols, both for the health of the donor mothers and for the quality and safety of the breast milk they decide to donate altruistically for the benefit of sick or premature newborns. In this context, international and national experience has proven that the creation and operation of a National Network of HMBs is a successful strategy to contribute to achieve a reduction in infant morbidity and mortality, in addition, they are a very effective reference for the promotion of breastfeeding. HMBs are specialized establishments, generally dependent on Hospitals with Maternity Services, which offer the services of collection, processing, storage, distribution and quality control of donated breast milk, which requires adequate areas, professional trained in handling babies in special situations. The benefits of HMBs are numerous. The administration of breast milk is particularly effective for feeding newborns who are at risk, either because of extreme prematurity, low birth weight or other special condition (CALMA-UNICEF-MINSAL, 2017). Premature and low birth weight babies are characterized by having an immature digestive system and need breast milk which is more digestive to feed and properly absorb all their nutrients. It has been shown that feeding preterm infants with breast milk prevents the incidence of necrotizing enterocolitis caused by the ingestion of other milks. In addition, breast milk improves their immune system, protects them against infections, and contributes to their growth, maturation and development (WHO, 2002). In 2017, a study conducted by CALMA evidenced that during the first years of the operation of the HMB of San Salvador, within the National Women´s Hospital "Dra. María Isabel Rodríguez", as the level of coverage with PBM increased, a sustained reduction in the incidence rate of ECN was evidenced. This coincided with the increased coverage of preterm and low birth weight infants fed with pasteurized human milk with the implementation of the Strategy between 2013 to 2016 (CALMA-UNICEF-MINSAL, 2017). Some studies such as "Lactation with colostrum in necrotizing enterocolitis of the neonate" have concluded that early breast milk in treatment improves the clinical and radiological evolution of infants, preterm with ECN. Other studies published in the journal Lancet , conclude on the importance of pasteurized human milk as a protective factor against NEC "In infants fed exclusively on formula, confirmed disease was 6 to 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk. Pasteurized donor milk appeared to be as protective as raw breast milk. Among infants born at more than 30 weeks' gestation, confirmed necrotizing enterocolitis was rare in those whose diet included breast milk; it was 20 times more common in those fed formula alone. (CALMA-UNICEF-MINSAL, 2017)" 3 With all this background, the analysis of the operability of the HMB-HMCC network within the framework of the “Crecer Juntos” National Policy that prioritizes the promotion of breastfeeding as one of the foundations for the Salvadoran infant population to reach its maximum development potential, consolidating the results that have been obtained to date as a friendly strategy for children at risk, based on scientific evidence and that also promotes, protects and supports breastfeeding through the establishment of a culture of human milk donation. At the same time, it will allow feedback to key cooperating partners that have provided support for this initiative, such as UNICEF, the Cooperation of the Government of the Federative Republic of Brazil and the efforts of different institutions, such as the Salvadoran Women's Parliamentary Fund, the Neonatal Alliance and CALMA. 4. Methodological Approach In order to fulfill the general objective, the specific objectives and scopes previously defined, this study has combined the review of bibliographic references, official information on the national network of HMB-HMCC with primary information collected through interviews with the institutional team that manages the three existing HMB and a sample of fourteen HMCC selected through a purposive sampling of geographic representativeness and of the public-private actors participating in the initiative. The type of study developed was characterized by being: Descriptive, because it allowed detailing the functioning of the three existing HMBs with respect to promotion, collection, extraction, distribution of human milk and their working relationship with the HMCCs in their geographic jurisdiction, developing a process with the participation of the team of professionals. Transversal, because the variables were studied simultaneously at a given moment, making a cut in time. Deductive, through the exposition of concepts, definitions, regulations to draw conclusions and consequences in real life. Participatory and reflexive, since it includes interviews, surveys and feedback and validation consultation workshops with representatives of key actors for the research. The primary hypothesis of the study has been the verification that the HMB network is functioning with the necessary efficiency and effectiveness, taking advantage of the existing installed capacity for the promotion, collection, storage, transfer, pasteurization, administration and subsequent dosage of breast milk for its target population. In the evaluation of this hypothesis, a multidisciplinary team from CALMA, made up of eight professionals specialized in breastfeeding and breast milk bank management, under the leadership of the main consultant of the study, actively participated, conducted a particular analysis of each of the currently operating HMBs and a sample of HMCCs to establish their operating conditions and the key factors that are influencing production (individually and as part of HMB networks acting for the benefit of the affiliated maternity hospitals) and their current utilization to maximize pasteurized breast milk production with the available resources. As a starting point for the analysis, three structured interviews with Senior MINSAL Officials were conducted (i) Director of Health Policies and Management, (ii) National Coordinator of the HMB-HMCC Network and (ii) Head of the Integrated Child Health Care Unit. 4 In the next stage, a compilation of historical-operational information and interviews with the technical team responsible for the visits to the three HMBs and a sample of 14 HMCCs were carried out: HMB of San Salvador and a sample of 4 HMCC attached to UCSF (Planes de Renderos, San Martín, Puerto de La Libertad and Unicentro-Soyapango) and HMCC at Zacatecoluca National Hospital. HMB of Santa Ana and 6 HMCC (ISSS Hospital Regional Santa Ana), 2 in HMCC attached to Manufacturing Companies, San Julián Integral Center for Maternal and Child Care and Nutrition CIAMIN and 2 HMCC attached to MINSAL National Hospitals of Ahuachapán and Chalchuapa. HMB of San Miguel, HMCC at UCSF San Miguel - Colonia La Presita and 2 HMCC attached to MINSAL National Hospitals of Usulután and Morazán. To complement the qualitative information, a survey of donor and recipient mothers was conducted through virtual means on a representative sample of women who have participated in the process at HMB-HMCC . This survey allowed broadening the horizon of the research and diagnosis to consider data collection among a broad conglomerate of the population that has been involved in the HMB-HMCC initiative. The selection of donor mothers was carried out with a probability sampling technique based on the approximate universe of 2326 donor mothers registered in the HMB-HMCC , as this method allowed all mothers registered as donors to have the same probability of being chosen and therefore to obtain a greater possible assurance that the important characteristics of the population under study were represented in the proportion that corresponds to them. Finally, during the phase of field visits to the sample of 14 HMCC, selected jointly by MINSAL and CALMA, it was possible to observe a wide dispersion of operational and institutional conditions in the territorial networks of HMCC attached to each of the three HMB, so it was agreed with the National Coordinator of the HMB-HMCC Network to carry out an operational census that would gather the main production variables and a basic characterization of the operational conditions. 5. Conceptual framework Human Milk Banks and Collection Centers HMBs are internationally recognized as a fundamental and decisive strategy to save the lives of infants in special conditions. The purpose of HMBs is to "provide pasteurized human milk to newborns in special conditions, mainly those who are premature and of low birth weight when, due to their same condition, they cannot be directly breastfed" (CALMA-UNICEF-MINSAL, 2017). In El Salvador, the initiative for the implementation of HMBs began with the participation during the month of September 2010, in the "I Ibero-American Congress of Human Milk Banks", where representatives from 24 countries met and El Salvador adhered to the signing of the 2010 Brasilia Charter as part of international efforts to address infant mortality and aim at strategies for the fulfillment of the Millennium Development Goals, in force at that time. Within the framework of the First Brazil - El Salvador Cooperation Project called "Technical Support for the implementation of a Human Milk Bank in El Salvador", the work process begins for the establishment of the first HMB within the National Women's Hospital "Dr. María Isabel Rodríguez", (see Figure 5-1) with the financial and technical support of UNICEF and CALMA. 5 Figure 5-1: Chronology of the establishment of the HMB-HMCC network in El Salvador. Source: (CALMA-UNICEF-MINSAL, 2017). Subsequently, always with the support of UNICEF, CALMA and now with the Neonatal Alliance of El Salvador and the Fund of Women Parliamentarians of El Salvador, the process of implementation of two more Milk Banks begins, within the Regional Reference Hospitals: Hospital San Juan de Dios de Santa Ana and Hospital San Juan de Dios de San Miguel, a project that would culminate with the opening of the three HBMs in October 2012 and February 2013. The regulatory framework that accompanies the development of the HMB-HMCC Network is based on the provisions of: The Law for the Promotion, Protection and Support of Breastfeeding approved in 2013, which establishes in its Article 20 "Human milk banks are responsible for collecting, analyzing, pasteurizing and executing the processes of conservation, classification, quality control and distribution of breast milk for the infant unable 6 to receive breastfeeding from its mother... the donation of human milk must be free, no public, private institution or natural person may establish pecuniary cost for obtaining or distributing it. The State and all public, autonomous and private institutions shall obtain the donation of human milk for girls and boys who cannot have access to it." In the regulation approved in 2015, it is established in Article 24 "in the case of premature newborns, breast milk should be promoted and indicated as a priority for infant feeding or, feeding through human milk banks and only when all possibilities of feeding with human milk have been exhausted, breast milk substitutes may be resorted to." The Salvadoran Network of HMB is officially constituted under Ministerial Agreement No. 686 and has expanded nationwide, with HMCC within UCSF, maternity waiting homes, and national hospitals with maternity services. The Salvadoran Social Security Institute ISSS has been involved in the process and public-private alliances have been generated with companies committed to this strategy and within the scope of international cooperation, it has positioned itself among the countries of the Global Network of Milk Banks, advancing from the consolidation of the national network to the adherence to the quality certification program of the establishments that make up the national network, as illustrated in Figure 5-2 (CALMA-UNICEF-MINSAL, 2017). Figure 5-2: Territorial network of HMBs and their network of HMCCs. HMCC HMB Source: MINSAL, November 2021 The HMB Network is made up of two structures (see Figure 5-2 above): In the first tier are the HMBs, which operate within a maternity or children's hospital, responsible for the promotion, protection and support of breastfeeding, which also carries out activities of collection, processing and quality control of expressed human milk, for subsequent distribution to the beneficiary newborns. At the second tier, the HMBs have attached to their technical and operational jurisdiction a Network of Human Milk Collection Centers (HMCC). A HMCC is defined as a unit for the promotion, protection and support of breastfeeding, which is also responsible for collecting and pre-storing human milk from altruistic female donors, technically linked to an HMB. 7 The HMCCs have been a fundamental piece in the consolidation of the national HMB network, not only because of their contribution to the volume of milk collected, but also because they represent a true example of integrated work in networks, where the conviction and desire of the resources to make a difference in favor of the reduction of neonatal mortality and the promotion of breastfeeding prevails. A fundamental strategic contribution to the creation and strengthening of the HMB-HMCC Network has been the Basic Agreement on Technical, Scientific and Technological Cooperation between the Governments of the Federative Republic of Brazil and the Republic of El Salvador, which has allowed for technical and financial support to the process of implementing the Network. Based on the aforementioned Cooperation Agreement, several technical verification missions have been carried out, the last of which took place in May 2018 and was integrated by a technical team from the Oswaldo Cruz Foundation - FIOCRUZ, the Ministry of Health of the Federative Republic of Brazil under the sponsorship of the Brazilian Cooperation Agency (ABC/MRE). As a result of this mission, a series of technical recommendations were compiled that are guiding the certification process of the HMB-HMCC Network before the Global Network of Human Milk Banks and provide a valuable reference for the process of improving the operational conditions of the three Salvadoran HMBs. Efficiency analysis The efficiency analysis was carried out based on the use of the system's installed capacity. The installed capacity is the production potential or maximum production volume that a particular company, unit, department or section, can achieve during a given period, taking into account all available resources, whether production equipment, facilities, human resources, technology, experience/knowledge, etc. The general procedures for the operation of the HMB-HMCC Network were defined in 2017 by MINSAL in the technical guidelines for the implementation and operationalization of human milk banks and collection centers document. , which aim to "guarantee the right to health and food and nutritional security, preserving the quality of pasteurized human milk for the newborns benefited, in order to achieve the best results in the survival and development of children in special conditions and thus contribute to the reduction of infant morbidity and mortality and the protection of breastfeeding". These guidelines also define the Salvadoran Network of Human Milk Banks, which is made up of the HMBs of the hospital network, the ISSS and other members of the National Health System that have HMBs, as well as the HMCCs. For the purposes of this study, the HMB Network is defined as the conglomerate of three territorial networks of HMCC attached to an equal number of HMB attached to them within the hospital network of the Ministry of Health and the HMCC of the private sector. The operation of the Strategy is conceptualized as a system of three operational phases, plus a phase prior to the entire system, phase 0, consisting of the process of incorporating donors into the system (see Figure 5-3). Figure 5-3: PBM production line in the HMB-HMCC Network. Phase 0: Recruitment or enrollment of donor mothers Phase 1: DBM collection Phase 2: Processing of DBM to obtain PBM 8 Phase 3: Dosage of PBM distributed among the beneficiary population of the strategy. The "zero" phase consists of all processes necessary to recruit donors to the system, which includes the care and counseling provided by the network's facilities (on-site and at home). The information for this phase was collected simultaneously with the staff attending the HMB-HMCC network and was complemented with donor surveys to estimate the average number of breast milk donations per person. Phase 1 considers the collection of raw DBM. This phase is developed jointly by HMCCs and HMBs. In this phase the HMCC network attached to each HMB transports the raw DBM according to established procedures, generally on a weekly basis. Phase 2 processing is carried out at the HMBs, where the final selection of the DBM takes place (verifying aspects of quality, cleanliness, safety and expiration dates), to then carry out the batch pasteurization cycle of the raw DBM, as described below. Finally, Phase 3 consists of the delivery of pasteurized breast milk (PBM) to the beneficiaries of the strategy, i.e., preterm and low birth weight newborns who are in the Neonatal Intensive or Intermediate Care Units and Neonatology Services of the Hospitals with HMB. The efficiency analysis was carried out based on the use of the system's installed capacity. The installed capacity is the production potential or maximum production volume that the HMB-HMCC network can achieve during a given period, taking into account all the resources they have available, be it production equipment, facilities, human resources, technology, experience/know-how, etc. Low utilization of installed capacity means underutilization of infrastructure and thus higher PBM cost produced and consequently a low level of coverage of preterm and low birth weight infants and increased use of breast milk substitutes to meet the demand for pasteurized milk. Figure 5-4: Key elements for the HMB-HMCC network efficiency analysis. 9 Box 5-1: MINSAL guidelines on home milk collection. Guidelines for HMBs Each HMB will identify the donors that have been served in the last year and contact them for home donation of breast milk if they are within their area of responsibility... Those that cannot be visited, lists should be provided to each HMCC in their area of responsibility, so that they can contact the donors. The management of each hospital should facilitate transportation for home visits. Guidelines for HMCC In UCSF where HMCC operates, no care will be provided to donor mothers, however, information will be provided to be a home donor and the general data will be noted down and visited by the health team, prior scheduling. The person in charge of the human milk collection center is in charge of receiving the list of donors provided by the HMB, to coordinate home visit... Provide counseling during the home visit to pregnant women, on breastfeeding and home donation. Source: (MINSAL, 2020). The HMB Network has a clear and delimited outline of the processes and resources required for optimal functioning during phases 1, 2 and 3, which include: 1) Technical procedures for the collection of human milk 2) Prestorage of collected human milk 3) Transport and cold chain 4) Receipt of collected human milk 5) Selection and classification 7) Conditioning 8) Pasteurization 9) Cooling 10) Microbiological analysis of pasteurized human milk 11) Storage of pasteurized human milk 12) Prescription of pasteurized human milk 13) Distribution of pasteurized human milk 14) Handling of pasteurized human milk 15) Receipt and follow-up of recipients (MINSAL, 2017). Phase "Zero" is mainly oriented with the guidelines issued by MINSAL in 2020 after the beginning of the pandemic (Technical guidelines for the operation of human milk banks and collection centers during the COVID-19 emergency). These guidelines emphasize a notable importance on the design and operation of home collection programs with donor mothers following their medical care, both for HMB and for the HMCC network, with their respective follow-up mechanisms (see Box 5-1). In production systems, it is normal for there to be factors that affect the level of production, and one of them is shrinkage. In economic terms, shrinkage is the loss of stock that is reflected in the accounting and the actual accumulated stock. Applying this concept to the HMB strategy, "shrinkage" can be defined as the reduction in the volume of human milk collected during the different stages of processing to the final product, i.e. pasteurized milk. To carry out the analysis, the maximum volumes of each factor between June 2020 and June 2021 were estimated. Finally, the analysis included the analysis of the losses or shrinkage that occur throughout the process. In this regard, two types of losses are considered, the first of which are the "normal" losses in the pasteurization process, which are estimated to be equivalent to 2% to 3% of the initial volume of DBM entering the pasteurization process. The second type of losses is conceptualized as "abnormal" and is associated with incidents of a fortuitous nature due to human action (it could also be defined as all losses that is not of a normal nature). In the case of the present study, abnormal losses is that which exists for preventable reasons such as failure to ensure hygiene, the cold chain, broken or damaged bottles, among other aspects. Therefore, it is important to measure the efficiency of the system and establish a yield factor for breast milk. 10 Analysis of key factors for improvement in the operation of the HMB-HMCC network. Once the efficiency of the system has been established, an analysis of key operating points has been developed. In this sense, a review of the factors that have a direct impact on efficiency has been prepared: 1) Human resources 2) Equipment 3) Infrastructure 4) Human Milk donation. The structuring of the analysis considers four weighted dimensions of impact evaluation, in which each of the factors has on the processes executed in the HMB-HMCC network, also considering aspects such as budgetary impact, the feasibility of implementing corrective measures and the need to make modifications to MINSAL's regulatory instruments and institutional policies. Table 5-1 shows the correlation between the criteria and the dimensions of analysis of the key operating points, which are rated on a scale of three (as the highest value) to one. Table 5-1: Matrix analysis of improvement factors for the operation of the HMB-HMCC network. Analysis Criteria High (3) Medium (2) Low (1) Impact on the process Key factor in the development of the process. Moderate impact on the process in the current condition. Low impact on the process, manageable with current resources. Budget impact Significant investments that require budget allocations and/or international cooperation projects. Significant investments within available resources, may eventually require reprogramming. Investment items available in manageable amounts. Feasibility of implementation Requires significant coordination efforts within MINSAL and external actors. Coordination efforts are needed among actors already working with MINSAL. Inter-institutional and internal work in process. Policy and guideline reviews Requires a major revision of institutional policy instruments and regulations, with a strong component of dissemination, awareness raising and internal training. Moderate adjustments to existing instruments accompanied by a process of sensitization and updating of capacities within MINSAL. Working within existing guidelines, reinforcing MINSAL team capacities. Source: Own elaboration Based on the structure of criteria and weightings illustrated in Table 5-1, the analysis of the most important aspects of coordination in the HMB-HMCC network is developed in Chapter 7. Qualified, trained and motivated human resources are a determining factor in production capacity; therefore, it is important to determine whether there are areas for improvement in human resources and the solutions that would increase the efficiency of the HMB Network. 11 As regards furniture and equipment, aspects such as quality and quantity, maintenance and replacement, among others, were identified. Regarding infrastructure, the influence of the dispersion of the HMCCs assigned to each HMB and the impact this has on the efficiency of the system was analyzed, as well as other aspects related to the infrastructure of the HMCCs and HMBs that could be susceptible to improvement. Finally, the importance of the donor and the factors that determine the amount of milk collected by region and at the national level were analyzed and how to improve them. Other cross-cutting aspects that were considered in this analysis were: The quality of the processes: those qualitative aspects related to quality assurance from donor counseling, labeling, safeguarding the cold chain, among other aspects, were verified. Monitoring and evaluation of the HMB strategy: This was analyzed as part of the continuous improvement elements that must exist for the HMB strategy to detect limitations, propose and develop solutions. Coordination between units of the HMB strategy: The analysis provided information on aspects related to the frequency and quality of coordination between units at regional and national level that allow for improving aspects such as communication, resource management, capacity building, among others. 6. Findings of the HMB-HMCC Network Efficiency Analysis The key results of the implementation of the HMB-HMCC Network have been grouped according to the four stages illustrated previously in Figure 5-3. Phase Zero: Donor Mother Recruitment The updated processes for recruiting donor mothers are set out in general terms in the document "Technical guidelines for the operation of human milk banks and collection centers during the COVID-19 emergency", in which, as previously mentioned, importance is given to complementing the procedures for recruiting donor mothers in health facilities and through home collection programs. The territorial network of 55 HMCC existing as of October 2021 is mainly located in UCSF (27), Maternal Waiting Homes (2) and National Hospitals with Maternity services (17). In the Santa Ana HMB network, there are 6 facilities attached to Manufacturing Companies and three facilities attached to ISSS health centers. In the territorial network of the HMB of San Miguel there is a predominance of HMCCs located in national hospitals, which is the opposite of the trend observed in the other two territorial networks. For the recruitment of mothers, each facility establishes its own methodology according to its situation and the environment in which it works, but in general, the difference in the success of recruitment is the availability of personnel and the amount of time dedicated to recruitment. From the field visits carried out for this study, it was found that: The recruitment of donor mothers in the UCSFs is based on prenatal care services and postpartum followup consultations. The people who attend the HMCCs carry out activities to recruit potential donor mothers during working hours in other health care areas of the UCSFs and, eventually, activities to promote the services. In all cases, breastfeeding and feeding counseling services are provided to newborns. 12 In the hospitals (both in the national network and in the two cases of the ISSS), the main source of donor mothers is also the population that attends the hospital services, with the additional possibility of recruiting donors among mothers who have their babies admitted for some medical procedure and who are allowed to stay in the shelters set up for this purpose inside the hospital facilities. Another advantage that hospitals have over the UCSF is the possibility of recruiting donor mothers outside normal working hours, although this is not a usual and established practice in most hospitals. In both types of facilities (HMCC in Hospitals and in UCSF), before the pandemic, in general, special events were developed to recruit donor mothers, informative campaigns in favor of breastfeeding and maintained a closer contact with their communities of care, especially in the HMCC that depended on UCSF and its network of health promoters (this practice was discontinued after the pandemic). In the HMCCs located in Manufacturing Companies, donor mothers come from factory workers, who take advantage of the benefits established in the Law for the Promotion, Protection and Support of Breastfeeding and its Regulations, to take time to express milk for breastfeeding their babies, donating part of their milk to the HMB of Santa Ana, which organizes regular collection routes. Breastfeeding promotion and counseling activities are carried out in the companies to encourage the donation process. The best practices identified at HMCC are associated with involving the nursing staff in mother recruitment rounds, actively visiting the main areas of care for women under rotational schemes, as well as providing counseling and educational talks on breastfeeding issues. After the COVID19 pandemic, community activities have been reduced to a minimum, human and physical resources have been reallocated to COVID19 care (first to emergency care and then to vaccination) and in general, the number of mothers who voluntarily participate in donation activities has decreased in many facilities, as could be verified during the visits. During the visits and interviews, it was established that the guidelines issued in 2020 are not being applied extensively in the HMCCs visited, mainly in relation to home collection. Only three of the fourteen facilities visited have a household program, of which only UCSF San Martin operates in a structured manner: UCSF San Martín has organized periodic collection routes that include breastfeeding counseling activities, assigning a person responsible for accompanying the routes and visiting donor mothers. For this activity they have printed guidance material and the administrative support of transportation to develop the routes. This case can be systematized as an operational example regarding the guidelines issued by MINSAL in 2020. In operational terms, it works very similarly to the home-based programs of the three HMBs described below. UCSF Los Planes de Renderos has home collection as its only DBM collection modality, given that it does not have a space for donor mother care within the UCSF. Because the UCSF changed location and the new facility does not have physical space to operate. The home collection routes allow them to collect an average of 0.5 to 0.9 liters of DBM. USCF La Presita has a home program that operates irregularly on the personal initiative of the nurse in charge of the facility; it is not structured on a permanent basis and does not have logistical support for transportation, so it frequently relies on the support of altruistic individuals. In the three cases of UCSF home programs verified, there is no logistical support for transportation from the HMB to which they are attached. 13 The three HMBs have a structured program in accordance with the MINSAL 2020 Guidelines, of which the best organized is the BHL of San Salvador. HMB personnel carry out an active breastfeeding counseling campaign with mothers who are identified through daily rounds to identify potential donors in the maternity, neonatology, puerperium, mothers' shelter and outpatient services. During the counseling sessions, they are encouraged to donate their surplus breast milk on a permanent basis as an act of solidarity for the infant population in need of PBM support. The home donation program receives administrative support for transportation with home collection routes, which in the case of HMB Santa Ana, include visits to private companies and the ISSS Regional Hospital. An important part of the success of San Salvador's home milk collection program is the establishment of breastfeeding support groups using social networks. These initiatives engage mothers' interest in donating and facilitate the coordination of breast milk deliveries. In the HMBs of San Salvador and Santa Ana, communication groups have been organized through social networks and in the particular case of San Salvador, the strategy of forming support groups and sharing communication and educational material through social networks has been implemented. All these elements contribute to the establishment of an effective household collection (see Figure 6-2). According to the figures presented in Figure 6-1, between June 2020 and June 2021, the home-based program contributes more than half of the milk collected in the HMB of San Salvador (52%) and the lowest contribution is observed in the HMB of San Miguel (19%); in the latter, the largest contribution comes from the regionally attached HMCC network, with 72% of the total milk collected (the opposite occurs in San Salvador, where the HMCC network represents only 25% of the contribution). It is important to note that in the case of the San Miguel HMB network, HMCCs installed in National Hospitals predominate and, as will be seen below, the current performance level in DBM collection is higher than the collection in HMCCs located in the first level of health care (UCSF). 14 Figure 6-1: Structure of raw breast milk inputs to HMBs between June 2020 and July 2021 (liters). 349,96 Total HMB-San Miguel 54,17 687,72 117,90 HMB-Santa Ana 117,81 HMB-San Salvador 177,98 0% 10% 917,39 440,14 176,80 286,89 393,02 20% 30% 40% 50% 190,36 60% 70% 80% 90% 100% Breast milk collected at HMB (liters) Breast milk collected at HMB - Home collection (liters) Breast milk collected at HMCC (liters) Source: Own elaboration with data collected in the HMB-HMCC network. In the same period of time, in terms of yield, for each liter of milk collected at the HMB facilities, 2.2 liters are collected at home in San Salvador and San Miguel, although in the latter case, HMB personnel frequently have to use their personal vehicles to complete the routes. Based on the survey conducted among donor mothers for this study, it was possible to verify the importance of actively involving the HMB-HMCC network staff in the promotion of breastfeeding and the services During the visits to HMB-HMCC it was possible to verify offered by the network. that in all cases the processes outlined in the MINSAL Among the mothers surveyed, it was verified that the main mechanism of communication through which the HMB-HMCC network is made known is the information provided by MINSAL officials (39% when asked to users assigned to an HMB, 51% when asked to a donor mother identified with an HMCC), secondly, they knew about the network because the health facility they frequently visit has an HMB-HMCC (31%). Guidelines (MINSAL, 2017) for the enrollment and registration of donor mothers are followed. It was possible to verify that not in all HMCCs identification "carnets" are given to mothers. All records are kept in physical form without digitalized backup. On average, donor mothers remain 3.7 weeks as active donors in the process, and in 28% of the cases, they are repeat donors after their first delivery (the longest participation was the case of a mother who has been a donor for 61 weeks). 15 Among the mothers surveyed, it was verified that the main mechanism of communication through which the HMBHMCC network became known was the information provided by MINSAL officials (39% when asked to users assigned to an HMB, 51% when asked to a donor mother identified with an HMCC), and secondly, they knew about the network because the health facility they frequently visit has an HMB-HMCC (31%). On average, donor mothers remain 3.7 weeks as active donors in the process, and in 28% of the cases, they are repeat donors after their first delivery (the longest participation was the case of a mother who has been a donor for 61 weeks). From the results of the survey conducted, the following trends can be established: A mother donates on average 2.5 times a day (the maximum reported was 8 times). On average, the typical extraction ranges from five to seven ounces (0.15 to 0.21 liters) and takes an average of 22 minutes to perform. On average, a donor mother delivers 17.3 ounces per HMB transport visit (0.51 liters), making an average of 10.4 DBM deliveries during her active period. Among the mothers surveyed, 52% of the volume of milk donated was done directly at an HMB, 35% at HMCCs, and only 13% through home donation. In the case of the mothers surveyed who made home donations, 93% received the necessary supplies to carry out their donation. Phase 1: Collection of DBM The series of Tables 6-1-A, 6-1-B and 6-1-C show the compilation of the information obtained during the visits made to the facilities in the sample selected for the present study by each of the three territorial HMB networks: five HMCCs dependent on UCSF plus one case corresponding to a facility specialized in nutrition and child care attached a UCSF (San Julián), six HMCCs dependent on National Hospitals with operating Maternities and two HMCCs installed in private companies that operate within business clinics/breastfeeding rooms as established in the respective Law. Based on the series of Tables 6-1, it is possible to establish that the conditions for DBM removal in HMBs are more favorable in terms of infrastructure and equipment than those of the average HMCC with the exception of the private company facilities. When differentiating the cases of HMCCs, we distinguish those cases that were implemented as of the last quarter of 2019, for which MINSAL defined new operational standards for their implementation and which were supported by CALMA in key aspects of their equipment (armchairs to accommodate donor mothers, better refrigerators and even, better infrastructure conditions). 16 Table 6-1-A: Key aspects that define the operation of the HMCC network attached to HMB San Salvador. Medium size airconditioned room with privacy, separated from the common areas. Four comfortable armchairs with electric extractors. Normal refrigerator with a freezer that allows 6.0 lt storage. They are scheduled on a hospital minibus with primary route. Small living room without dividers for privacy. Four chairs (only two Normal refrigerator can be with a freezer allowing accommodated due 4.5 lt storage. to room limitations). Every Thursday at 7am, on a UCSF minibus with primary route. Small room without dividers for privacy. 8 chairs (hard). Large freezer (more than 10 lt storage). Every Friday at 7am, in a UCSF minibus with primary route. They do not have a lactation room. No armchairs because they do not have space for breastfeeding, they have two extractors. HMB San Salvador Transportation 2 staff, one full time and administrative support. SAN MARTIN Milk storage Part-time coordinator, ten nurses rotate at least one per month on a full-time basis (although she is able to take other jobs). UNICENTRO SOYAPANGO Donation chairs Part-time coordinator, no other support. LOS PLANES DE RENDEROS Collection rooms The same two people, eventually, there is support from health promoters in recruitment (3 to 4 of the 15 available). PTO. LA LIBERTAD Staff dedicated to recruiting donors 4 resources, but for each shift there is one person and the shifts are 12 hours long. Small room without dividers for privacy. Two chairs, two breast pumps. Wide freezer (more than 10 lt storage). Every Friday at 7am, is the most usual. Transported in a hospital ambulance with primary route. ZACATECOLUCA HMCC 2 people, one full time and the coordinator part time. Small room without dividers for privacy. Pleasant ambience. Two armchairs, three pumps. Wide freezer (more than 10 lt storage). Additional normal refrigerator. Every Friday at 7am, in a hospital minibus with primary route. Source: Own elaboration based on information compiled during the study. 17 Normal refrigerator In UCSF vehicles with with one freezer primary route. allowing 4.0 lt storage. Table 6-1-B: Key aspects that define the operation of the HMCC network attached to HMB Santa Ana. 2 people, one full time and administrative support. One full-time and the nursing staff supports this task on a parttime basis. Chalchuapa Ahuachapán San Julián HMB Santa Ana Staff dedicated to recruiting donors ISSS Santa Ana HMCC Part-time coordinator, a maternal and child health graduate and a part-time collaborator (undergraduate student in nutrition, although she is able to take other assignments). One full time, the nursing staff (14) supports this task on a part time basis, additionally there is a very intense collaboration of the Lactation Committee and its general coordinator. GOOD PRACTICE: use of a dedicated TV for video projection at HMCC and at the Shelter. One full-time, the coordinator and the nursing staff (9) support this task on a part-time basis. Collection rooms Donation chairs Milk storage Transportation Small air-conditioned room with privacy, separated from the common areas. Four chairs with electric extractors. Normal refrigerator with a freezer that allows 5.0 lt storage Two normal refrigerators with a freezer that allows 5.0 lt storage The deliveries are scheduled in a hospital minibus with primary route. Small room without dividers for privacy Seven chairs and manual extractors, accommodates two donors. Two normal refrigerators with one freezer allowing 5.0 lt storage. Every Friday at 7am, the most usual time, they are transported in a hospital ambulance with primary route. Small room without dividers for privacy. One recliner and two extractors (only one can be accommodated due to room limitations. Large freezer (more than 10 lt storage). Transfers are managed cooperatively with several health facilities in the area. San Julián does not have its own transportation. Small room with separate space for donation. Two recliners (2 at HMCC) and two electric extractors. Normal refrigerator with one freezer allowing 5.0 lt storage. Every Friday at 7am, the most usual time, transport is in a hospital ambulance with a primary route. Three recliners (2 at HMCC) and two electric extractors. Two normal refrigerators with one freezer allowing 5.0 lt storage. Every Friday at 7am, the most usual time, transportation is provided by a hospital ambulance with a primary route. Small room without dividers for privacy. 18 Private FolLamatepeq Private Fol-Santa Ana HMCC Staff dedicated to recruiting donors Two nurses attending the business clinic. They are in the process of expanding HMCC to a new location. Collection rooms Donation chairs Milk storage Transportation Small room without dividers for privacy. Pleasant ambience. One chair, one electric fan, one manual fan. Normal refrigerator with one freezer allowing 5.0 lt storage. Weekly, with routes coordinated with HMB. Small room without dividers for privacy. Pleasant atmosphere. One chair and two electric extractors. Normal refrigerator with one freezer allowing 5.0 lt storage. Weekly, with routes coordinated with HMB. Source: Own elaboration based on information compiled during the study. Table 6-1-C: Key aspects that define the operation of the HMCC network attached to HMB San Miguel. Staff dedicated to recruiting donors Collection rooms Small air-conditioned room with privacy, separated from the common areas. Five chairs with electric extractors. Normal refrigerator with a freezer that allows 5.0 lt storage. Transportation with coordination problems. HMB staff frequently use their personal vehicles. Small room without dividers for privacy. Two metal armchairs, two extractors. Normal refrigerator with one freezer allowing 6.0 lt storage. Every Friday at 7am, in a hospital ambulance with primary route. HMB San Miguel Transportation Two staff, one full time. San Francisco Gotera Milk storage Head of nursing, neonatology. La Presita Donation chairs Two people fulltime, but they involve all the nursing staff, such as the gynecologist and all the staff of the facility on a voluntary basis. Small room without dividers for privacy. There are three armchairs, but only one electric extractor. Normal refrigerator with one freezer allowing 5.0 lt storage. There is no dedicated transportation. Transfers are frequently made by urban transport (bus). Usulután HMCC Two staff, one fulltime and the coordinator parttime. Small room without dividers for privacy, very neglected conditions. Two hard-backed chairs. Two normal refrigerators with one freezer allowing 5.0 lt storage. They are scheduled in a hospital minibus with primary route. Source: Own elaboration based on information compiled during the study. 19 During visits to HMB and HMCC, it was verified that DBM identification and traceability records are in compliance with technical guidelines. This information is also supported by physical records and is the basis for documenting deliveries of raw DBM to the HMBs. The success of DBM collection in the establishments visited depends on the ability to manage donor mothers and the followup provided to them once their stay in the hospitals and the postpartum check-ups in the UCSF with attached HMCC is over, with the implementation of home programs as explained in the previous section. The current situation of infrastructure and equipment does not condition the operational performance, however, in several HMCC the infrastructure and equipment make the donation process neither comfortable nor private for donor mothers and require improvements in furniture, particularly in the cases of HMCC that have been in operation since 2015. Historically, the HMB-HMCC network has maintained annual collection averages on the order of 2,500 to 2,600 liters of DBM. Between 2013 and 2014, the network basically relied on DBM collection efforts at the three HMBs until HMCCs were gradually incorporated during 2015, the year in which the first 31 HMCCs nationwide became operational (the first HMCC in operation was the HMCC at UCSF Unicentro, Soyapango, in August 2014). During the interviews conducted, the HMB-HMCC Network Coordinator, those responsible for HMB-HMCC highlighted the development of massive recruitment and mother recruitment events during 2016-2017 which were then followed up with home collection schemes in the UCSFs with attached HMCCs, through their territorial health promoter structures. In these schemes, many UCSFs were particularly successful, such as HMCC UCSF Unicentro-Soyapango, which reached an all-time high of 39.0 liters in August 2017 and HMCC UCSF Los Planes de Renderos accumulated 22.0 liters of DBM. The start of the DBM cold chain in the HMCC network relies in most cases on normal (household) refrigerators, which are equipped with freezers that allow storage of an estimated 4.5 liters to 6.0 liters of DBM. In the year leading up to the pandemic, DBM uptake was 2,198.2 liters; in 2020, the amount of DBM collected dropped to 1,720.7 liters following the onset of the pandemic. According to MINSAL projections, production by the end of 2021 is expected to reach 2,500 liters of DBM. With the data collected between June 2020 and June 2021, totaling 1,955.1 liters of DBM, this positive upward trend can be verified. Only 4 of the 14 HMCCs visited have horizontal freezers. The use of household refrigerator freezers has the disadvantage of not guaranteeing the safety of the DBM, since it was observed in some cases that the lower part of the refrigerator is used to store food or beverages of the establishment's personnel. Phase II Processing of DBM to obtain PBM After completing the DBM collection process in the HMB-HMCC network, the three HMBs develop an exhaustive process of integration, storage, processing and distribution of the PBM, following standardized protocols and performing bacteriological controls, to distribute PBM to the neonatal population (premature, low birth weight or presenting special health conditions). As the nutrient and amino acid content of DBM varies, depending on the gestational weeks and postnatal age of the donor neonate, the customized delivery of PBM, taking into account gestational and postnatal ages, has proven to be the most beneficial strategy for the nutrition of preterm neonates with specialized feeding needs. 20 The processing or pasteurization of DBM is based on the Holder methodology, which is the reference procedure used for the processing of DBM in milk banks globally, as it offers a good balance between microbiological safety and preservation of the nutritional/biological quality of the milk. The guidelines are developed by MINSAL in the document "Technical guidelines for the implementation and operationalization of human milk banks and collection centers" (MINSAL, 2017), specifically in chapters 9, 10 and 11, and basically consists of rapid heating by immersion in a hot water bath of a standardized amount of homogeneous vials of milk to 62.5 °C, A detailed study of processing times and steps followed by an "intermediate" stage at 62.5 °C for 30 minutes and is not available to verify an optimal pattern to a rapid cooling phase to 4 °C (this cooling phase prevents the maximize process yield at the three HMBs. proliferation of residual bacteria). This technique has demonstrated high microbiological safety, eliminating most bacteria and viruses with the exception of sporulated bacteria and hepatitis B virus (Picaud JC, 2017). The Holder pasteurization process is carried out at all three HMBs under the same performance standards, with minor variations in processing quantities per batch. In the three HMBs the processing duties essentially depend on the Laboratorian assigned to each of the HMBs. Processing is completed on a daily production line, the volume of which depends on the type of milk to be processed and yield standard, which is basically set at a combination of number of equal volume vials that are processed in each production batch. The laboratorians of the three HMBs emphasized that for the process to be considered effective and safe, temperature changes must be homogeneous regardless of the distribution of the bottles in the pasteurizer and the volume of milk they contain. The devices used in the HMBs are water-heated pasteurizers and, as will be seen in the next chapter, the equipment used in the three HMBs has already exceeded its nominal useful life, which is reflected in the production capacity. According to the interviews conducted with the laboratorians at each HMB, based on the equipment available at each HMB, currently the maximum throughput among the three HMBs is 4 to 5 liters on average for a complete daily pasteurization cycle (with a normal processing shrinkage of 2% to 3%). Based on the information collected and interviews conducted during visits to the three HMBs, Table 6-2 has been constructed, which summarizes the total milk captured for the period June 2020 to June 2021 and the total volumes of PBM produced. Table 6-2: Pasteurized milk production June 2020-July 2021. Element of analysis HMB-San Salvador HMB-Santa Ana HMB-San Miguel Total DBM collected at HMB (liters - year) 571.0 294.6 172.1 1037.7 DBM received at HMB from affiliated HMCCs (liters - year) 190.4 286.9 440.1 917.4 Total DBM (liters - year) 761.4 581.5 612.2 1955.1 Abnormal loss in PBM production (literyear) Percentage of abnormal loss vs. uptake 76.6 118.0 38.5 233.0 10.1% 20.3% 6.3% 11.9% Total PBM (liters - year) 687.6 455.2 563.0 1705.7 Source: Own elaboration based on information compiled during the study. 21 The above table shows the importance of reviewing the collection processes of DBM from the HMCC network attached to the Santa Ana HMB, given that it has a higher percentage of abnormal losses or depletions than the other HMBs and this supply source is equivalent to half of the total DBM collected in the territorial network of the western zone (see previously illustrated in Figure 5-2). Similar attention is required, given the importance of the San Salvador HMB household program (51.6% of the DBM - see Figure 5-2). Table 6-3: Abnormal DBM losses in the HMB-HMCC network June 2020 - June 2021. Element of analysis Percentage of milk discarded with respect to breast milk collected HMB-San Salvador HMB-Santa Ana HMB-San Miguel 10.1% 20.3% 6.3% Household collection HMCC shipments HMCC Shipments Main reason for discards Consistency/color 38.1% Dirt 39.7% Second reason for discards Acidity Consistency/color 94.0% Positive bacterial cultures Main source of discarded breast milk Third reason for discards Acidity 32.0% 5.0% 22.2% Presence of dirt Thaw Expiration 15.2% 1.0% 17.0% Source: Own elaboration based on information compiled during the study. Phase III Dosage of PBM Once the PBM has passed the selection and microbiological control processes and ensures compliance with all applicable standards, the HMB personnel carry out the production inventory by manual means of recording in physical control books for the custodian and subsequent distribution among the neonatal beneficiary population. PBM inventory, control, requisition and prescription procedures are not uniform among HMBs and need to be evaluated and modernized. All records are kept manually, without digital backup. Follow-up on the evolution of the beneficiary population is very limited and does not include a file associated with the medical discharge report and the impact of the PBM on health, nor is there follow-up after the hospital stay. This process would also facilitate a home donation program. The prescription follows medical and nutritional criteria established by the NICUs of each HMB and, in this regard, it is noteworthy that the collection of prescriptions is not standardized, while in the HMB of San Salvador, the staff visits the medical areas of the Hospital daily to collect and inventory PBM requests, in the other HMB, it is the heads of the medical areas who visit the Bank to periodically distribute their PBM requirements for the beneficiary population. This difference in methods and controls existing in the three HMBs does not support the efficiency and effectiveness of the distributed PBM dosing process and makes it difficult to track, trace and evaluate the impact of PBM prescription among the beneficiary population. Figure 6-2 shows the historical trend since 2016 of the numbers of babies benefiting from PBM and compared with the cumulative data between June 2020-June 2021, it can be established that an estimated 1,300 to 1,400 premature babies, very low birth weight (less than 1,500 grams) and special conditions are benefited annually to 22 which an average of slightly more than one liter of PBM is administered, with 2020 being the year of lowest dosage (0. 92 liters / baby benefited), which can be attributed to the operational difficulties observed for the collection of DBM associated with the sanitary measures due to the COVID-19 pandemic, in health facilities at the national level. Figure 6-2: Historical trends in PBM delivered and babies benefited. 1600 1.45 PBM/baby (liters) 1.60 1.23 0.92 1.05 1800 1600 1400 Number of babies 2000 1400 1200 1200 1000 1000 800 800 600 PBM (liters) 1800 600 400 400 200 200 0 0 2017 2018 2019 Number of babies benefited 2020 June20/june21 Amount of PBM distributed (liters) Source: Own elaboration based on information compiled during the study. The accumulated trend during June 2020-June 2021 is similar to that observed in previous years, and the figures at the end of 2021 are expected to be higher than those of the previous year. HMB Santa Ana has negotiated and signed a cooperation agreement with the ISSS Regional Hospital of Santa Ana. This initiative has been generated locally and has not been replicated in the other HMBs. This agreement allows (i) that hospital to operate an HMCC that supplies the HMB and in turn (ii) transfers PBM from the HMB to babies housed in the NICU of this hospital. This is the only case of PBM transfers outside the HMB. Based on the information gathered during the visits to the three HMBs, Table 6-4 summarizes the results obtained during the period between June 2020 and June 2021, where it can be seen that the largest number of babies benefiting from distributed PBM is located in the HMB of San Salvador, followed by the HMB of San Miguel and finally, by the HMB of Santa Ana. In the particular case of the HMB of Santa Ana, the production of PBM is the lowest of the three banks, partly due to the significant percentage of discards that exceeds that of the other two banks and because it also has the lowest number of babies attended (a figure that includes 19 patients from the ISSS Regional Hospital, which means that the dosage received by the beneficiary population is two liters per baby). 23 Table 6-4: Statistics on production and delivery of PBM to beneficiary babies at HMB Element of analysis HMB-San Salvador HMB-Santa Ana HMB-San Miguel Total Volume in liters of PBM 687.6 455.2 563.0 1705.7 Volume in liters of PBM distributed 672.5 626.7 349.9 1649.1 Total number of babies benefited 902 275 394 1571 Number of babies benefited in other Maternities 0 19 0 19 TOTAL 902 294 394 1590 Average PBM per baby attended 0.75 2.28 0.89 1.05 Number of donor mothers enrolled 882 632 1761 3275 Source: Own elaboration based on information compiled during the study. Installed capacity utilization In the case of the HMCCs, the comparison between the average current productions versus the maximum historical yield was used, accumulating trends by type of establishment to which the HMCC is attached and by geographic network. Table 6-5 presents the current monthly DBM production versus historical maximums by HMB territorial network and type of establishment of affiliation, grouping the averages by geographic area and by type of establishment, with the purpose of establishing orientation trends. 24 Table 6-5: Yields by territorial network and type of establishment to which the HMCC is attached. Average Current vs. historical maximum Average Yield Average Current Average Yield liters/month Historical vs. current yield differential liters/month Element of analysis HMCC Average Maximum Yield (liters/month) HMB Santa Ana 17 9.8 35.7% 2.3 7.6 HMB San Miguel 19 5.1 31.4% 2.0 3.1 HMB San Salvador 19 10.4 27.4% 2.3 8.0 Total 55 8.5 31.4% 2.2 6.3 Element of analysis HMCC Average Maximum Yield (liters/month) Average Current vs. historical maximum Average Yield Average Current Average Yield liters/month Historical vs. current yield differential liters/month Manufacturing Companies 6 44.1 4.1% 3.3 40.8 National Hospital 17 6.9 47.4% 3.5 3.4 Community Family Health Clinic 29 7.4 24.0% 1.4 6.0 ISSS Medical Clinic or Hospital 3 8.2 26.5% 2.4 5.8 Total 55 8.5 31.4% 2.2 6.3 Source: Own elaboration based on information compiled during the study. Based on the information in Table 6-5, it can be concluded that the HMB-HMCC network is currently operating on average at 31.4% of the historical maximum DBM collection capacity (comparing the average collection during the first eight months of 2020 with the historical maximums achieved between 2016-2017, which is very similar among the territorial networks attached to the three HMBs). The comparison is justified by the fact that, according to the data provided by MINSAL, the yields in the first eight months of 2021 are equal to the same period of 2019 (pre-pandemic year). On a territorial scale it can be observed: Santa Ana's network is operating at 35.7% of historical maximum throughput, while San Salvador's network has dropped to 27.4%, which is a rough indicator of how much the available installed capacity is being utilized for each case. In the analysis according to the type of health facility, the performance of the HMCCs attached to National Hospitals with Maternity maintained average yields equivalent to 47.4% of the historical maximum, compared to 24.0% in facilities located in UCSF/HEM and with a productive capacity equivalent to 2.6 times. 25 This is more accentuated in the San Salvador and Santa Ana networks. When the analysis is done by type of facility, private company HMCCs have historically captured the largest amounts of DBM and currently present the most significant drop (more than 95%). As previously mentioned, the raw breast milk collection processes in the three HMBs have household collection schemes, apart from having a private room to accommodate donor mothers with comfortable chairs and mechanized pumps, which provide a suitable environment to facilitate the donation process. PBM production performance factor Current utilization of installed capacity at HMBs was calculated from information provided by HMB laboratorians, which is summarized in Table 6-6. Table 6-6: Maximum throughput standards at HMBs. Data - Laboratorian HMB-San Salvador HMB-Santa Ana HMB-San Miguel Maximum output Weekly production 16 bottles of 320 ml = 5.12 liters 14 jars of 300 ml = 4.20 liters 18 bottles of 300 ml = 5.40 liters One production cycle per day - 3 production cycles per week Daily volume (with normal loss) Monthly volume (with normal loss) 5.0 liters 64.5 liters 4.1 liters 52.9 liters 5.3 liters 68.4 liters Source: Own elaboration based on information compiled during the study. In the practice developed at each HMB, the maximum throughput standard is concluded by the maximum capacity of homogeneous vials per production batch according to the equipment available (information provided by the three HMB laboratorians), is concluded by the values illustrated in Table 6-7. Table 6-7: PBM production yield factor at HMB. Element of analysis HMB-San Salvador HMB-Santa Ana HMB-San Miguel Total Total DBM (liters/year) 761.4 581.5 612.2 1955.1 Discarded DBM (liters-year) 76.6 118.0 38.5 233.0 Total PBM (liters-year) 687.6 455.2 563.0 1705.7 PBM yield factor Current production capacity (liters/month) Maximum production capacity (liters/month) Installed capacity utilization 90.3% 78.3% 92.0% 87.2% 56.4 37.3 46.1 46.6 64.5 52.9 68.4 61.9 87.4% 70.5% 67.5% 75.2% Source: Own elaboration based on information compiled during the study. 26 HMB-Santa Ana and its network of affiliated HMCCs require a special capacity building effort to reduce "abnormal" wastage and increase the production of the HMCC network. According to the interviews conducted with the laboratorians of the three HMBs: (i) 3 PBM production cycles are developed in a working week, the other two days are dedicated to preparation, cleaning and revision of cultures; and (ii) the production capacity can be increased by developing two daily production cycles or by introducing a fourth process during the week, but this depends on more human resources, work outside nominal working hours and physical space (which is limited in each Bank). In addition, HMB's equipment requires that its equipment capacities be made compatible to increase its pasteurization capacity. Based on the information collected and interviews conducted during the visits to each of the three HMBs: (i) it was calculated as the correlation in percentage between the annual total of breast milk that has been pasteurized in the HMBs and the annual total of breast milk collected (in its natural unprocessed state) in the National Network and, (ii) from the information in Table 6-7, it can be concluded that the HMB-HMCC network has managed to transform 87. 2% of the raw milk collected in PBM suitable for distribution to the neonatal beneficiary population. The difference is attributed to the normal loss of processes (according to the standards of the pasteurization equipment available, this value is usually 2% to 3%) and the rest to the abnormal loss of DBM prior to the pasteurization process. Based on the information gathered, with the production data and the production standards provided by the laboratorians of the three HMBs, it is concluded that an average of 75.2% of the operational production capacity is being used based on "normal" operating parameters (a single production line in three working days of operation and the conditions of the human resources and equipment available). The San Salvador HMB has the highest nominal production rate; however, the San Miguel HMB has the best standards of utilization of the DBM and the lowest percentage of abnormal losses. The production capacity of pasteurized milk can be improved with short-term measures, increasing human resources specialized in processing/laboratory and improving equipment, without modifying the infrastructure of the three HMBs. Pasteurized breast milk production line capacity. The production capacity among the four PBM production phases illustrated previously in Figure 5-3 has been calculated on the basis of (i) the average yields of the HMB-HMCC network in DBM derived from Table 6-2, (ii) combined with the PBM yields calculated with the combination of the statistics in Tables 6-6 and 6-7, and finally, (iii) with the PBM delivery data to beneficiary infants in HMB. The results of this cross-tabulation are presented graphically in Figure 6-3, on which the following details are highlighted: Based on the historical average yield of the HMB-HMCC network, equivalent to 2,600 liters of DBM and the amount of DBM captured between June 2020 to June 2021, the amount of milk that could be captured in Phase 1 exceeds by 340 liters the amount of DBM that could be processed with the current yields of the three HMBs in Phase 2. This means that the current processing capacity of the network would not be able to assimilate an increase in DBM capture yield that would match the historical average of the network. 27 If the current average processing capacity of the three HMBs were maximized by increasing the amount of current DBM to the productive maximum with the current pasteurization equipment, an additional 524 liters of PBM could be produced. This capacity to increase PBM would serve to feed an additional 533 newborns to those currently served, for a total of 2,123 newborns. Figure 6-3 Pasteurized breastmilk production line capacity Source: Own elaboration based on information compiled during the study. 28 Coverage of the demand for pasteurized breastmilk The PBM dosage is distributed among newborns weighing less than 1500 grams, premature newborns with special feeding needs and newborns with high-risk pathologies (e.g. necrotizing enterocolitis, neonatal sepsis and immune deficiencies). From the situations illustrated above, the cases of infants presenting 1500 grams or less at birth have been selected to analyze PBM coverage. This group of newborns constitutes a high-risk group in relation to developmental problems and therefore require special feeding with mother's breast milk or PBM from an HMB, more rigorous medical follow-up and more controls than those required for a child born with higher birth weight. Table 6-8 presents the national totals of newborns weighing less than 1500 grams at birth and the number of cases that manage to be attended in the three hospitals with maternity wards that have an HMB attached to them. It is important to highlight two aspects: (i) the HMBs of San Salvador and San Miguel only distribute PBM among newborns from their headquarters maternity hospital and (ii) the only HMB that makes transfers outside its facilities is the HMB of Santa Ana that shares it with newborns from the Santa Ana ISSS Regional Hospital through a special agreement (in that hospital operates a HMCC that collects DBM for that HMB). In Table 6-8 it can be concluded that the average coverage of newborns under 1500 grams covers approximately 44% of the average number of cases presented between 2017 to 2020, observing a decrease to 41% during the year of the pandemic, due to the existing conditions for the operability of the network based on health protocols and access to donor mothers (the amount of DBM captured in the network in that year fell to 1720.7 liters, 66% of the historical average). The above figures would support the development of an institutional policy in MINSAL to operationalize the transfer and storage of PBM with national hospitals, ISSS and private hospitals that have a NICU for the treatment of cases that require PBM for the treatment and feeding of newborns with low birth weight, prematurity or special pathologies. This good practice can be systematized/modeled from the HMB of Santa Ana with the Regional Hospital of the ISSS. Table 6-8: Coverage of newborns under 1500 grams at the national level MINSAL. Hospital - HMB 2017 2018 2019 2020 HMB San Salvador 232 191 222 160 HMB San Miguel 60 44 45 48 HMB Santa Ana 28 26 23 20 Total HMB (babies) 320 261 290 228 National Total (babies) 630 654 639 561 National coverage 51% 40% 45% 41% Source: Own elaboration with information provided by MINSAL. 29 7. Analysis of improvement factors to optimize the operation The information compiled in the previous chapter has served as a basis for analyzing key operational factors of the HMB-HMCC network in five categories linked to operational aspects and three associated with crosscutting processes of quality management of the processes carried out in the network, coordination within the management and operational teams, and finally monitoring and evaluation of all processes. Recruitment of donor mothers In the preceding sections, it was concluded that the HMB-HMCC network operates at 31.4% DBM collection rate compared to the maximum historical collection rate, and it was established that the processes of counseling, recruitment and loyalty of donor mothers are a key factor for the operation, which especially influences the collection of DBM in HMCCs. In order to characterize this area, three key elements are considered: recruitment methods, the use of donor mothers' sources of origin, and the implementation of a follow-up program for donor mothers in a home donation program. As previously highlighted, the mothers who donate their milk come from the health facilities to which they are attached in the HMB-HMCC network. During the visits, it was found that the full potential of donors is not being used and there is no systematized follow-up of the enrollment process; in most cases, mothers make their donations while they or their babies are being cared for at the health facility. In this context, it is very important to improve and optimize the methods for recruiting donor mothers. In this issue there is a methodological dispersion and the recent guidelines concluded by MINSAL in 2020 are being partially applied, which is reflected in a decrease in the number of donor mothers and in the fact that donor mothers are not permanently enrolled, particularly in the generality of HMCC and the low level of repeat donations in the HMB of San Miguel. It is very important to gradually resume, according to the COVID-19 protocols, actions to recruit and retain donor mothers that proved to be successful in past years and to support this management with printed and virtual communication material taking advantage of social networks, as is done by the HMB of San Salvador with its "Support Groups" strategy. To complement these efforts, it is advisable to create a monitoring and follow-up system for donor mothers, so that a home donation program can be implemented, with the logic and procedures defined by MINSAL in the "Technical guidelines for the operation of human milk banks and collection centers during the COVID-19 emergency" (MINSAL, 2020). 30 Box 7-1 Key operating factor assessment – Recruitment of donor mothers Average Process Impact Average Budget Impact 3.0 1.0 Recruitment of donor mothers Policy and Average Feasibility guideline review of Implementation average 2.3 2.3 This key performance factor of the network is the most important determinant for increasing PBM production. These strategies have a low budgetary impact, but require an intense effort in sensitization and capacity building, particularly in the network that depends on the Santa Ana HMB. The values in the table are calculated based on the weighting of three factors: Source of donors, Recruitment methods and Household program (see Table 5-1 in the methodology chapter for an explanation of the categories and values). Source: Own elaboration based on information compiled during the study. Human Resources HMB Human Resources The staffing structure among the three HMBs is similar: a part-time HMB Coordinator, a laboratory technician, two maternal and/or child care/nutrition technicians, an administrative assistant and a cleaning assistant (BHL San Salvador has one as part of the general subcontract). In addition, there is administrative support in Transportation on a rotational basis. In this structure, the person who concentrates the greatest responsibilities within the production chain is the laboratorian, whose training is in clinical laboratory, with additional training in breast milk processing, bacteriological control and breastfeeding. In the three HMBs this person concentrates on running all PBM production and quality control processes, as well as primary responsibility for production and inventory controls, which serves as the basis for administering the PBM dosages that are delivered to the hospital's NICU. These functions are difficult to delegate, so the absence or indisposition of this person greatly affects the productivity of the HMB. Secondly, the two people hired as support technicians, generally with a Bachelor's degree in Maternal and Child Health or Nutrition, are responsible for inventory and quality control of the DBM prior to processing, as well as the administration of PBM requisitions and their subsequent delivery to the NICU. This function is shared in parallel with the activities of recruitment, enrollment, registration and counseling of donor mothers, which are also critical for HMBs, especially in the case of San Salvador and Santa Ana. A third critical function, which derives from the previous one, is the operation of the household donation program. The Coordinator and support technicians have an average of five to six years of experience managing the HMB and have received the following training courses: HMB information management course. International tutor course in HMB. Breastfeeding course. Breastfeeding Counseling Course. Course on the International Code of Marketing of Breast Milk Substitutes. 31 Laboratory personnel have received at least three courses associated with Human Milk Processing and Quality Control, theoretical and practical aspects. Based on the interviews conducted at the management level in MINSAL and with the staff of the three HMBs, it can be concluded that the staffing structure does not favor the optimal functioning of the network, because it limits the productive capacity (on average, the three HMBs operate at 75.2% of their nominal installed capacity see previously Table 6-7 - and they do not take full advantage of the active follow-up to the recruitment and loyalty of donor mothers, including the household donation program. It is important to note that the HMBs of San Salvador and Santa Ana have administrative support for operational support, particularly in the management of transportation for the activities related to the home donation program, as well as an administrative assistant. In both aspects, the San Miguel HMB is deficient. For HMB management, it is advisable to conduct a time and motion study to support the operation and process guidelines to improve the productivity of HMB human resources and evaluate modifications to institutional guidelines. The performance and working conditions derived from the DBM pasteurization processes are a key factor for the overall performance of the HMB-HMCC network, given that, together with the state of operation of the pasteurization equipment and the limitations of the infrastructure, they condition the production of PBM to a single daily production cycle. Under current HMB operating conditions, it is very difficult to conclude whether the optimal yield previously defined in Table 6-5 (Maximum yield standards in HMBs) can be improved, unless an additional laboratory technician is delegated to each facility with staggered schedules that allow the incorporation of one additional production cycle per week. This aspect should be studied very closely at the time the pasteurization and laboratory equipment at HMBs is renewed. Human resources at HMCC The human resources structure in HMCCs is varied and constantly changing. In the sample of HMCCs visited for the present study, it can be concluded that the majority of facilities operate with a part-time Coordinator, who shares functions with the facility to which the HMCC is attached. This person assumes the general administrative coordination of the facility and in many cases is responsible for its technical operation. In addition to the Coordinator, nursing personnel from the health facility to which the HMCC is attached support part-time the operational management and, in most of the HMCC attached to a national hospital, they are supported by nursing personnel from the medical area to which the HMCC is attached (usually the Head of Neonatology or Maternity). During the visit, it was found that these structures function adequately, and even with remarkable operational results (particularly in San Francisco Gotera, Usulután, Zacatecoluca, Ahuachapán and the Regional Hospital ISSS of Santa Ana). The series of Tables 7-1-A, 7-1-B and 7-1-C summarizes details on the assignment of personnel in the 14 HMCCs visited for this study in each of the three territorial networks attached to the HMBs, detailing the specialized training courses that the personnel currently managing them have received. 32 Table 7-1-A: Staff attending the HMCCs visited for the present study in the HMB network of San Salvador: Experience and training courses. HMCC Staff CALMA MINSAL online basic course San Martin Two Nurses 2 Unicentro Soyapango Coordinator Los Planes De Renderos Coordinator (nutritionist) Puerto La Libertad Zacatecoluca Bachelor in Maternal and Child Health (3) Coordinator (nutritionist) and Nurse HMB Internships 2 1 1 3 3 2 2 Local Breastfeeding Courses 1 Other training at CALMA Other trainings Years of experience HMCC 2 1 6 1 6 1 5 2 0.5 2 0.3 Source: Own elaboration based on information compiled during the study. Table 7-1-B: Staff attending the HMCCs visited for the present study in the HMB network of Santa Ana: Experience and training courses. HMCC ISSS Santa Ana San Julián Ahuachapán Chalchuapa Empresa Privada FOLSanta Ana Empresa Privada FOLLamatepeq Staff Coordinator (Doctor in Neonatology) and Nurse Coordinator (Doctor) and Bachelor in Maternal and Child Health Two Nurses CALMA MINSAL on-line basic course 2 Local HMB Breastfeeding Internships Courses 2 1 Other training at CALMA Other trainings Years of experience HMCC 2 1 5 1 0.5 1 1 Two Nurses 2 0.5 1 2 Two Nurses 1 No information provided Two Nurses 2 Source: Own elaboration based on information compiled during the study. 33 Table 7-1-C: Staff attending the HMCCs visited for the present study in the HMB network of San Miguel: Experience and training courses. HMCC San Francisco Gotera La Presita Usulután Staff CoordinatorChief Nursing Officer (Master's Degree in Health Services Administration; Bachelor's Degree in Nursing) 6 Nurses Two Nurses Nurse Coordinator (B.S. in Nursing) and 6 Nurses CALMA MINSAL on-line basic course HMB Internships Local Breastfeeding Courses 2 3 2 3 Other training at CALMA Other trainings Years of experience HMCC 2 3 6 2 2 2 6 3 3 4 7 Source: Own elaboration based on information compiled during the study. From the information in Table 7-1, it is possible to conclude that the preparation and experience of the personnel involved in HMCC management is variable, in general terms (see Table 7-2): The staff of the HMCC network territorially attached to the HMB Santa Ana have the least experience managing HMCC (1.8 years) and evidence the least amount of training courses. This lack of experience and training may be the basis for the considerable percentage of abnormal shrinkage in this network (20.3%) compared to the other two networks. The HMCCs attached to San Miguel HMB have an average of 7.0 years of experience managing the facility and have accumulated the greatest number of training courses, which results in the fact that the HMB San Miguel network has the lowest percentage of abnormal losses (6.3%). 34 The staff of the HMCC network territorially attached to the HMB San Salvador has intermediate values in terms of experience and presents the greatest diversity of courses and topics. It occupies second place in the number of personnel who have taken training courses. Table 7-2: Summary of experience and training courses by HMB territorial network. HMB-HMCC Network HMB Santa Ana HMB San Miguel HMB San Salvador Average Years of HMCC experience Quantity of training courses 1.83 14 When analyzing the condition by type of facility, the situation is very variable in the HMCCs attached to UCSF, 7.00 31 with cases of notable management using nursing staff 3.56 26 rotation systems similar to those in national hospitals (UCSF San Martín, CIAMIN San Julián), with extreme Source: Own elaboration based on information compiled cases in which the entire operational responsibility of the during the study. HMCC falls on a single person, who performs these tasks part-time with little administrative support or infrastructure/equipment facilities of the health facility to which they are attached. Two cases notably exemplify this situation, HMCC Unicentro, Soyapango, a facility that came to set historical records for DBM collection within the network (39 liters/month) and HMCC Planes de Renderos, which also had remarkable performances between 2016 and 2018 (up to a monthly maximum of 22 liters/month), both of which declined notably, especially HMCC Planes de Renderos when UCSF changed premises. This variable structure and with constant personnel movements notably hinders the operational coordination processes and formative trainings for the correct operation of the HMCC, particularly in the HMCCs that depend on a UCSF. The result of this is the limited compliance with the operational guidelines concluded by MINSAL and the low performance of the facilities attached to UCSF compared to those operating within National Hospitals. By applying the criteria and weightings previously defined in Table 5-1, it can be verified that human resource management in the HMB-HMCC network is the second most important key operational factor with the greatest impact on the operational functioning of the network, together with the condition of the equipment for pasteurization processes in HMBs. Modifying this situation requires a notable budgetary effort to rearrange priorities and give greater importance to network management within health facilities, particularly considering the COVID-19 pandemic care measures, in addition to requiring an intensive process of sensitization and updating of knowledge among the structure of personnel who directly or indirectly work in the HMB-HMCC network. Box 7-2 Key operating factor assessment – Human resources Average Process Impact Average Budget Impact Human resources HMB 3.0 2.0 3.0 3.0 Human resources HMCC 3.0 2.0 2.5 3.0 Policy and Average Feasibility guideline review of Implementation average This key network performance factor has the greatest impact on network performance. These strategies have a significant budgetary impact and require a broad review of institutional and regulatory policies, which must be accompanied by an intense effort in awareness and capacity building, particularly in the network that depends on the Santa Ana HMB (see Table 5-1 in the methodology chapter for an explanation of the categories and ratings). Source: Own elaboration based on information compiled during the study. 35 Infrastructure HMB Infrastructure The three HMBs are attached to National Hospitals with maternity services with NICU. In all three, spaces have been accommodated for a layout with (i) reception and administration, (ii) DBM extraction room with sanitary isolation, (iii) production area (pasteurization), (iv) Laboratory and DBM/PBM storage, (v) cleaning and disinfection, (vi) general storage - staff room. The distribution of spaces is functional, but still needs to be improved according to the results of the last ABC/MINSAL verification mission of the Global Network of Human Milk Banks1. The facilities of the three HMBs were evaluated by a commission of Brazilian experts as part of the certification process for the Global Network of Human Milk Banks, which resulted in a series of technical recommendations that, according to information provided by MINSAL, have not been fully complied with. Currently, the technical redesign of spaces in the San Salvador HMB is in its final stage, which will serve as a basis for modeling modifications in the other two HMBs. The main limitation of the infrastructure is the concentration of space to accommodate a single production line for pasteurization of DBM and certain restrictions for the installation of modern equipment for performing bacteriological tests for quality control of PBM, particularly for the installation of laminar flow chambers for handling samples in a clean and sterile contamination-free environment (currently such tests are performed with the aid of burners). The milk collection area for donor mothers is very functional and comfortable, providing a safe and clean private space to accommodate the donation process. HMCC Infrastructure The HMCCs visited as part of the present study are mostly attached to UCSF and National Hospitals with Maternity services and are installed in a room of 10 to 12 m2 in area, generally without internal divisions (except for those in Ahuachapán and Zacatecoluca). The spaces assigned to the HMCC are reallocations of existing areas with previous uses different from the nature of the operation of this type of facility. The rooms assigned to the HMCC are reallocations of existing areas with previous uses different from the nature of the operation of this type of facility and accommodates all the operational tasks of the HMCC, including the donation process, which in most cases lacks the necessary equipment to ensure the privacy and comfort of the donor mother. Of the fourteen HMCCs visited, most do not have access to their own restrooms, and only four of them have washbasins and toilets. Except for the cases of the private company, the walls have not been decorated to favor and/or educate the breastfeeding process. The visits included two HMCCs built and equipped in 2021 in the National Hospitals of Ahuachapán and Zacatecoluca, in which the improvement of the operating standards established by MINSAL was verified. These new guidelines conclude HMCC with separation of areas with more comfortable and private spaces to facilitate the donation process. It should be noted that, in both cases, MINSAL has received support from the Office of the First Lady of the Republic and CALMA for the equipment, setting and habilitation of these HMCC. 1 The final report of the mission included a series of observations on the infrastructure of the three HMBs, including the reorganization of internal circulation flows, separation and isolation of areas with sanitary isolation, and information management systems. 36 In general, with the current operational conditions of the HMCC network, this is not a key factor limiting their operational capacity; however, in the future, it would be highly recommended to make a greater effort to improve the physical and operational conditions to improve DBM collection and donor care. Box 7-3 Key operating factor assessment – Infrastructure Average Process Impact Average Budget Impact HMB Infrastructure 3.0 3.0 3.0 2.0 HMCC Infrastructure 1.0 1.0 2.0 2.0 Policy and Average Feasibility guideline review of Implementation average This key performance factor is more relevant to the operation of HMBs, because it limits the productive capacity of PBM. In the case of HMCCs, it would significantly facilitate the recruitment of donor mothers and make the donation process more private, dignified and comfortable (see previously in the methodology chapter Table 5-1 for explanation of categories and ratings). Source: Own elaboration based on information compiled during the study. Equipment HMCC equipment Three situations can be clearly distinguished in the HMCC network: (i) in the cases of HMCCs inaugurated before 2019 the furniture is very limited and has not been renovated recently, except for donations of armchairs to accommodate the donation process, (ii) in the cases of HMCCs attached to private companies, they have new furniture and rooms set with acrylic decorations that illustrate the process and benefits of breastfeeding, and (iii) the HMCCs inaugurated recently, have more modern furniture and equipment to accommodate the most efficient and comfortable way the donation process. As previously explained, the furniture itself is not a key factor for the operation of the facilities, however, it is advisable to update it, especially in cases where donor mothers perform their donation process on uncomfortable and hard chairs. In the three HMBs, the donation room in San Salvador is equipped with modern and comfortable furniture; those in the Santa Ana and San Miguel HMBs have normal plastic chairs, without cushioning. HMCC Freezers As previously mentioned, the start of the cold chain for DBM in the HMCCs is mainly carried out using normal household refrigerators; only four of the fourteen facilities visited have a horizontal freezer. The refrigerator freezers installed in the remaining HMCCs are capable of accommodating an average of four to six liters of DBM. This includes some cases of recently opened HMCCs (Ahuachapán as the most notable example). In the current situation, with the network operating at an average of 31.4% of its nominal capacity (and in the most exceptional cases, at 60% of its historical maximum throughput), freezers are not a key operating factor at this time. It is important to note that the use of home refrigerators in HMCCs does not fully ensure the safety of DBM preservation, given that in some cases the lower part of the refrigerator is used to preserve food, beverages, or other products. For this reason, when reviewing strategies for improving the operational capacity of the HMCC network, reviewing the HMCC cold chain may be an aspect of technical consideration. 37 To safeguard the cold chain, it is also key to consider in the analysis the availability of standardized glass jars, coolers and blocks of dry ice (known as "penguins") to transport the DBM to the HMB of assignment. In all the cases visited, the necessary quantity of the three inputs was available. In all the HMCCs, with the exception of the HMCC of the ISSS Regional Hospital and the two HMCCs of the private company, a record book is kept of the cleaning of ice chests and "penguins". Several HMCCs have a good practice of collecting bottles among the staff of the health facility to which they are attached, which has the collateral benefit of involving the staff in the operation and dissemination of the HMCC. Transportation at HMB - HMCC All facilities in the HMB-HMCC network depend on transportation services provided by the central administration of the health facility to which they are attached. This situation presents notable cases of coordination and collaboration, as well as extreme cases in which the heads of some facilities have to resort to their personal vehicles or public transportation to carry out DBM transport operations. The HMCC attached to private factories that have an operating agreement with the Santa Ana HMB are provided with transportation from the Hospital San Juan de Dios de Santa Ana in an efficient and timely manner. Transportation services are especially significant for the three HMBs, where DBM uptake is also coordinated on a household basis. San Salvador and Santa Ana have efficient collaboration from the central authorities of both hospitals. San Miguel frequently has coordination problems. This is a key factor for the overall performance of the Network, since it is an important detail to consider in order to conclude household programs in the majority of HMCC nationwide that do not have this modality of DBM uptake. HMB Equipment Table 7-3 shows the equipment inventory of the three HMBs and the average time of use for each type of equipment. In general terms, most of the equipment and furnishings are more than seven years old, which means that most of them have exceeded their useful life, especially the pasteurization and laboratory equipment. The previous chapter highlighted the fact that PBM production in the three HMBs depends basically on a single production line of pasteurization equipment. It should be noted that only Santa Ana has replacement equipment, albeit of lower capacity. This concludes a critical production route that, combined with the limitations of the room infrastructure dedicated to processing, explains that currently only one daily production batch of PBM is worked with a maximum average yield of five liters (see Table 6-6 in the previous chapter)2. Similarly, the equipment for laboratory tests and microbiological cultures has been in use for more than seven years, so most of it has exceeded its nominal useful life. Table 7-3: Average years of operation by type of equipment in HMBs (2021). Computer Equipment Average Years in Use 10.0 Oven dryer 8.5 Refrigerators 8.5 Laboratory Equipment 7.5 DBM exhaust fan 7.3 General Furniture Pasteurization Equipment Freezers 7.2 Equipment 7.1 6.3 Air Conditioners 5.3 General Average 7.3 Source: Own elaboration based on information compiled during the study. 2 In the case of the Santa Ana HMB, the performance is lower, since the cooler has a smaller capacity than the heater. 38 An important aspect is that in all HMBs the handling of biological culture samples for acidity tests and microbiological control is done in the ambient area with the aid of a Bunsen burner, which, although it is a procedure accepted by the applicable standards, is not the ideal procedure to guarantee the quality of the microbiological control. The test manipulation should be performed in a laminar flow chamber, which is an instrument used to have contamination-free environments, because it provides decontaminated air from particles down to 0.1 microns. Using a laminar flow chamber ensures a work area that always remains clean and sterile, an environment that offers better results than the use of lighters. The HMB in San Salvador has this equipment, but it is not used because the special gas bypass piping necessary for the equipment to function has not been installed. Finally, the freezers in the HMBs are, in most cases, specialized upright freezers in acceptable operating conditions and their capacity is adequate for the levels of DBM capture and PBM storage. In all cases, freezers are kept separate by specialization (pre-pasteurization storage, post-pasteurization quarantine, culture and PBM released for dosing). At this time they are not a key operating factor, but their capacity will need to be reviewed if strategies are developed to improve the level of PBM production. Inventory and Control Systems at HMB - HMCC None of the facilities in the HMB-HMCC network have digitized inventory and control systems. All facilities have computers and the reports required from the Network Coordination are prepared manually from physical records in Excel spreadsheets. This is a key factor for the monitoring and follow-up of the Network and the administration of the different operational aspects. Box 7-4 Key operating factor assessment – HMB Equipment Average Process Impact Average Budget Impact Laboratory Equipment 2.0 2.0 3.0 2.0 Pasteurization equipment 3.0 3.0 3.0 3.0 Other equipment 1.9 1.6 1.7 1.4 Policy and Average Feasibility guideline review of Implementation average Pasteurization equipment management at HMBs is the key performance factor of greatest impact to the network. At the time this report is being prepared, a plan to replace most of the equipment in the HMBs and some areas of the HMCCs is under budget and procurement management. These strategies have a significant budgetary impact and require an extensive review of institutional policies and regulations, which must be accompanied by an intense effort in sensitization and capacity building, particularly in the network that depends on the Santa Ana HMB. In addition, before and after completing the renovation of equipment in the HMBs, it is advisable to carry out a study of times and movements to conclude operational guidelines for the equipment of each HMB (see Table 5-1 in the methodology chapter for an explanation of the categories and valuations). Source: Own elaboration based on information compiled during the study. There are significant challenges to adapt the care processes, infrastructure and equipment in most facilities to the needs of the donor mother population in order to make the act of donation a comfortable, private and stimulating procedure. On this issue, the Network Coordination promotes the sending of management reports to the various internal entities involved in MINSAL and ISSS, but institutional evaluations of the procedures, care resources and methodologies are not carried out, although a collaborative spirit is fostered and the issue is part of the institutional follow-up priorities. In this regard, it is very necessary and convenient to expand collaborative efforts to exchange information with private companies and the ISSS and to create working relationships with academic institutions and their research programs. 39 Cross-cutting aspects of the HMB-HMCC Network The quality of the processes The Coordination of the HMB-HMCC National Network is in charge of developing the processes of periodic review and evaluation of the quality of the processes and their adequacy to the normative instruments in force. These evaluations are carried out through an annual program of visits to the HMB-HMCC National Network. The quality review of the processes as such is not systematized in a normative-programmatic document. A basic evaluation form is completed for each visit and a manual historical record is maintained. In these process quality reviews, the recommendations of the Global Network monitoring reports are also reviewed. The results of the visits and evaluation reports are discussed internally at MINSAL, especially with the Integrated Child Health Care Unit and with other units linked to the HMB-HMCC National Network in order to maintain levels of operability and process quality. The results of these evaluations are the basis for the revision and/or updating of operating procedures and guidelines. In this cross-cutting issue, it is important to note that there is no structured capacity building plan for HMB-HMCC personnel in a normative document. An annual mapping of HMB personnel capacities and the agenda of basic technical preparation courses derived from the recommendations of the Global Network (Brazil) are developed. With the HMCCs there is a high staff turnover, therefore, the Breastfeeding Course has been created in virtual format, which includes the main training aspects that allow the operation of the HMCCs, and however, it is not able to cover all the Network's staff. Monitoring and evaluation The National HMB-HMCC Network does not have a monitoring and evaluation plan. It is important to note that all records in the facilities are managed in physical files, so it is not possible to share information in real time from the facilities to the HMB coordination, but it is done periodically. For this purpose, a basic reporting structure has been created in Excel format, which is shared on-line with the facilities so that, based on the coordination of each HMB and its territorial network of HMCC, they report their monthly operating statistics, which are compiled and integrated by the Network Coordination. In this process, a file exchange platform has been created, which is manually updated and compiled by the Network Coordination. Additionally, the Network Coordination prepares a report in the Global Network system. The absence of a Monitoring System is one of the most important observations made during the ABC/MINSAL Technical Missions to the Global Network in the Network Certification process. The report compiled by the Network Coordination serves to provide monthly feedback to the national authorities on the productive functioning and the main operational variables of production, which also serves to provide feedback to the management areas of the Annual Operational Plan of the Network and MINSAL. Coordination between units The Coordination of the HMB-HMCC National Network is in charge of developing the necessary processes to articulate the working relationships within the Network from the Unit of Integrated Health Care for Children. To this end, a working group has been set up on a cell phone instant messaging platform and information is constantly shared from the Coordination Office to all those responsible for the facilities. However, it was observed that this mode of communication has the weakness of being predominantly vertical and operational, without promoting horizontal communication among peers to exchange good practices and innovative experiences in the processes of recruitment and care of donor mothers. It is necessary to build an internal process 40 for dialogue, knowledge management and information exchange among the members who manage the Network's facilities. There are significant challenges to adapt the care processes, infrastructure and equipment in most facilities to the care needs of the donor mother population in order to make the act of donation a comfortable, private and stimulating process. On this issue, the Network Coordination regularly shares management reports to the various internal entities involved in the HMB-HMCC Network within MINSAL and ISSS, but institutional evaluations of processes, care resources and methodologies are not carried out, although a collaborative spirit is fostered and the issue is part of the institutional follow-up priorities. In these areas, it is very necessary and convenient to expand collaborative efforts to exchange information with private companies and the ISSS, and to create working relationships with academic institutions and their research programs. Box 7-5 Key operating factor assessment – Cross-cutting aspects of the HMB-HMCC Network Policy and Average Feasibility guideline review of Implementation average Average Process Impact Average Budget Impact Process quality 2.5 1.0 2.0 3.0 Monitoring and evaluation 2.7 1.3 2.3 3.0 Coordination between units 2.0 1.0 2.0 2.0 The Network's cross-cutting management processes are an intangible but very important factor for proactive management in the Network. Currently, positive efforts are being made by the Coordination of the National HMB-HMCC Network; however, these can be improved by having a formal monitoring and evaluation system with computer resources that allow the processing and analysis of the Network's operational and institutional variables interactively and in real time. These strategies do not necessarily have a significant budgetary impact, but require collaborative work in MINSAL with other actors that can support these tasks, especially with academic institutions (see Table 5-1 in the methodology chapter for an explanation of the categories and evaluations). Source: Own elaboration based on information compiled during the study. Overall Weighting of Key Operating Factors Finally, Figure 7-1 shows the graphical comparison between the weighting results of the four analysis criteria for a total of 22 key operating factors previously studied and analyzed in detail in the previous chapter. Based on this analysis, it can be concluded that the five most key factors influencing the operation of the HMBHMCC Network are (i) The management of pasteurization equipment in the HMBs (and its relationship with the infrastructure and the human team that operates it), (ii) the management of human resources in the HMBs, (iii) the status of the infrastructure in HMBs, (iv) the integrated management of the control and inventory systems together with the Network's monitoring and evaluation system, and (v) the management and capacity building of the human resources that operate the HMCCs, especially considering that it is an environment with many staff rotations. The above serves to confirm the trends previously illustrated in Figure 6-3. 41 Figure 7-1: Key operating factors global assessment of the HMB-HMCC Network. Flasks HMB Freezers HMCC Freezers HMCC Infrastructure Coordination between units HMB furniture HMCC furniture Staff capabilities HMCC Processes Transport Household program Monitoring processes HMB Processes HMB laboratory equipment Donor source Recruitment Methods Human Resources HMCC Monitoring System Inventory and control systems HMB infrastructure Human resources HMB Pasteurization equipment 0 2 4 6 8 Average Process Impact Average Budget Impact Average Feasibility of Implementation Policy and guideline review average Source: Own elaboration based on information compiled during the study. 42 10 12 8. HMB Network Cost Analysis Based on the analysis of the information gathered from the HMB - HMCC Network establishments, it was very evident that estimating operating costs is very complicated, given that such information is not part of a formal monitoring scheme for the monitoring of the network's operations. For the first time, and as a result of the special request for information for this study, a preliminary estimate of the unit cost per liter of pasteurized breast milk produced in the national network has been made, for which the costs presented by the HMB of San Salvador have been selected as the most representative. Table 8-1: Analysis of Total Costs of the HMB Network - HMCC of San Salvador (data collected for June 2020 - June 2021) Element of analysis HMB-San Salvador Total annual operating costs HMB of San Salvador $85,680.91 DBM captured at HMB (liter-year) 571.00 DBM sent by the network of affiliated HMBs (liter-years) 190.36 Total DBM volume (liter-years) 761.36 Cost per liter of DBM collected HMCC $413.49 Total HMCC Cost $78,711.76 Total HMB + HMCC Cost $164,392.67 PBM volume (liters-year) 687.59 Cost per liter of pasteurized milk $239.09 Total number of babies benefited 902 Total investment per baby benefited $182.25 Source: Own elaboration based on information compiled during the study. 43 9. Key Findings from the HMB Network Donor Mother Perceptions Survey As mentioned above, 113 surveys have been compiled from the population of donor mothers to the HMB network during October and November 2021. From the results obtained, the following key findings can be concluded: i. 51% of the women surveyed are not in permanent employment, only 24% are employed with statutory benefits, 10.6% are self-employed without benefits. ii. Among donor mothers, the average age is 28 years old. On average, the mothers surveyed have two children. iii. 81% of donor mothers have had their babies in public hospitals (7% in ISSS). iv. 54% of the mothers surveyed are exclusively breastfeeding their babies (23% are mixed breastfeeding). v. 44% of the babies of the mothers surveyed have been premature (31 weeks on average, the extreme case 24 weeks). Of the total number of preterm infants, 86% have received milk from an HMB. vi. Of the total number of preterm infants who received pasteurized milk from an HMB, 98% considered that the milk received met the growth needs of their infants and 95% rated it as excellent. vii. The main communication mechanism through which the HMB-HMCC network is promoted is the information given by MINSAL officials (39% when asked to users attached to an HMB, 50% when asked to a donor mother identified with an HMCC), secondly, they learned about the network because the health facility they frequently visit has an attached HMB-HMCC (31%). viii. The main reason for a mother to donate breast milk is solidarity felt by collaborating with her donation (53% identify it as their most important motivation), secondly, because they consider that it helps to strengthen their breast milk production and thirdly, because of the breastfeeding counseling received. ix. Regarding the counseling received, 98% of the donor mothers stated that their doubts on the subject had been resolved and 85% stated that they had learned a great deal and modified their feeding practices for their babies. x. 89% percent of the evaluations on the care received in the national HMB-HMCC network are "excellent", while 73% of the facilities/infrastructure are evaluated as "excellent". Based on the results obtained, it is very important to highlight that the key factor in motivating donation will always be the management of human resources and the feeling of empathy and solidarity promoted by MINSAL personnel assigned to the network with donor mothers. In this sense, during the interviews it was possible to verify that most of the personnel working in the network are motivated and empowered to carry out their work, however, there are many limitations to achieve the goals, the main one being the work overload, the assignment of complementary tasks and the limited availability of communication material in quality and quantity to motivate and technically orient the act of donation. 44 10. Conclusions Based on the collected documentary information, as well as on the interviews conducted, it has been possible to conclude that the strategic approaches of the HMB-HMCC Network are very relevant and necessary to promote breastfeeding and provide the best possible feeding to preterm, low birth weight and special health condition newborns, thus responding to the National Policy to Support Early Childhood Development "Crecer Juntos" (Growing Together). The operation of the HMB-HMCC network has been operationally consolidated and has maintained a steady growth in the number of facilities: currently there are 55 HMCC organized in three territorial networks attached to the three HMBs and covering 10 of the 14 departments nationwide. The HMB-HMCC strategy is one of the most relevant contributions to the commitments made by the country for the fulfillment of Sustainable Development Goals SDGs, specifically with SDG3, Health and Wellbeing, Target 3.2... "By 2030, end preventable newborn and under-five deaths, with all countries aiming to reduce neonatal mortality to at least 12 per 1,000 live births, and under-five mortality to at least 25 per 1,000 live births". From the information gathered during the research, the following specific conclusions about the current conditions in its operation and management are established: On the recruitment of donor mothers (Phase 0): i. ii. The primary source of donors are the users of the care services of the health facilities to which HMBs and HMCCs are attached: According to the visits made to HMCC and HMB, it is concluded that each facility implements methodologies for recruiting mothers according to their situation and the environment in which they work. According to the results of surveys with mothers, the difference in the success of recruitment is the quality and coverage of the motivational messages provided by the staff in the counseling sessions, since mother-to-mother solidarity is the main incentive that motivates donors to participate in the process of breast milk donation. The new guidelines defined by MINSAL, after the COVID-19 pandemic, for the implementation of new HMCC are a remarkable leap in quality to improve the functionality of these facilities, providing more comfortable and private areas and spaces to facilitate the donation process. DBM Over-Capture (Phase 1): iii. The network operates under the operational guidelines defined by MINSAL and maintains annual DBM collection averages between 2,500 liters to 2,600 liters. In the year preceding the pandemic, the amount of DBM collected was reduced to 1,720.7 liters. iv. The HMB-HMCC network has the capacity to collect more liters of DBM, given that, based on data to date: For the time period analyzed (June 2020-June 2021), the Network is operating at 31.4% of the historical maximum uptake capacity. 45 HMCCs attached to National Hospitals maintain average yields ranging from 45% to 65% of the historical maximum, while UCSFs and Maternal Waiting Homes currently produce a quarter of their historical maximum value. According to MINSAL projections and the data collected for this study between June 2020 and June 2021, it is expected that the collection at the end of 2021 will reach an estimated 2,200 liters of DBM. On PBM production (Phase 2): v. Processing is completed on a single daily production line, the volume of which depends on the milk to be processed and the standards of operation with the available equipment. The processing of donated breast milk depends essentially on the Laboratorian and a maximum of five liters of Pasteurized Breast Milk per day is produced on average. In this context, the human resource (laboratorian) and the processing equipment are the key factors for the overall performance of the network. vi. Based on the statistics collected for the present study, there is a need to evaluate the processes of DBM collection, PBM processing and information management in each HMB and its attached HMCC network, with the purpose of improving collection, decreasing discarding and increasing the number of final beneficiaries. vii. The maximum amount of milk that can be collected in Phase 1 is estimated to be between 2,600 to 2,700 liters, which exceeds the maximum capacity of Phase 2 of 2,229.6 liters (see Figure 6-3 in the previous Chapter 6). In this scenario, 370 to 470 liters would not be processed, suggesting the importance of upgrading equipment and strengthening personnel for breastmilk milk processing. viii. If the current average processing capacity of the three HMBs were maximized by increasing the amount of current DBM to maximum production with the current pasteurization equipment, an additional 524 liters of PBM could be produced. ix. The current processing capacity of the network would not be able to assimilate an increase in DBM capture yield that would match the historical average of the network. The maximum possible that DBM collection could be increased so that the HMB system does not collapse is on the order of 370 to 470 incremental liters per year (which equates to approximately 2,600 to 2,700 liters of DBM per year). x. The processing and handling of laboratory samples is performed in the laboratory environment with the aid of a burner to ensure the safety of the samples for bacteriological culture. The procedure could be improved with the use of laminar chambers (the HMB of San Salvador has new equipment that has not been installed). xi. According to the interviews conducted with the laboratorians of each HMB, based on the equipment available at each HMB, the normal loss (shrinkage) of processing is 2% to 3%. However, according to the 46 analysis of the present study, the abnormal losses of the network is 11.9% on average, i.e., 8% higher than recommended. xii. The operational condition of the Santa Ana HMB and its territorial HMCC network needs to be evaluated and its capacities strengthened. The Santa Ana HMCC network has an exceptionally high percentage of abnormal losses before being processed in the Bank and this source of supply is equivalent to half of the total DBM captured in the territorial network of the western zone. It is important to note that it was concluded that this territorial network is the one with the highest personnel turnover, as it has the lowest average experience and the lowest number of training courses received, compared to the other two territorial networks. PBM delivery and dosage (Phase 3) xiii. With the current production and geographic coverage of the HMB-HMCC network, an average of 44% of the demand for PBM among the population of newborns weighing less than 1500 grams born in MINSAL has been covered. xiv. Procedures for inventory, control, requirement and prescription of PBM are not uniform among HMBs and need to be evaluated and modernized. xv. All records are kept manually, without digital backup. xvi. Follow-up on the evolution of the beneficiary population is very limited and does not include a file associated with the medical discharge report and the impact of the PBM on health, nor is there follow-up after the hospital stay. This process would also facilitate a household donation program. On Cross-cutting Processes xvii. It is important to note that all records in the facilities are managed in physical records, so it is not possible to share information in real time from the facilities to the HMB-HMCC Network Coordination, but it is done periodically through a monthly on-line file exchange system. xviii. In this sense, it is important to mention the urgent need for a Monitoring, Evaluation, Accountability and Learning (MEAL) system for the Network that allows the generation of standard reports, decision making and continuous improvement. xix. The HMB-HMCC National Network Coordination maintains the necessary processes to articulate the working relationships within the Network based on the Integrated Child Health Care Unit: xx. There is a national level coordinator that stimulates communication between HMB-HMCC . It is important to promote the exchange of experiences among the different members of the Network in order to have the opportunity to learn about good practices in different regions and the way in which they solve problems from the territory. 47 xxi. Very positive collaborative processes of information exchange have been initiated with the private sector, ISSS, civil society organizations and academic institutions to promote capacity building and the implementation of collection centers. 11. Lessons learned Best practices Based on the systematization of the information obtained, the following Best Practices have been identified: i. Promotion, management and operation of cooperation agreements at the local level between: ISSS and Santa Ana HMB (agreement managed at the local level). Private companies (factories) and Santa Ana HMB. ii. Creation of a support network for donor mothers from the HMB of San Salvador using free tools in social networks (Instagram and WhatsApp). iii. Systematize the experience of HMCC supported by private companies in terms of:: Decoration and ambience (color of walls, furniture, equipment, ventilation, lighting, among other factors) Educational material for the donor mother and various incentives that build mom's loyalty to the strategy. iv. Local gardens in health facilities for the cultivation of the plant used to make a beverage that increases the production of breast milk (Euphorbia lancifolia also known as Ixbut plant), which have been implemented in the Hospitals of Chalchuapa, Ahuachapán and the ISSS Hospital in Santa Ana.. v. Rotation of nursing personnel in alternate shifts to promote breastfeeding counseling and recruitment of donor mothers (National Hospitals of San Francisco Gotera and Usulután). vi. Placement of flat screen televisions in the waiting areas and maternal shelters with a circuit of promotional videos on breastfeeding issues in the Ahuachapán hospital. vii. Several HMCC have as a good practice to collect bottles to collect DBM among the staff of the health facility to which they are attached, which has the collateral benefit of engaging staff in the operation and dissemination of the HMCC. viii. It should be noted that CALMA has made important contributions in equipment for HMCC, strategic communication for the HMB-HMCC Network, among other actions within its commitment to be part of the Global HMB Network as a representative of Civil Society. 48 Strategic opportunities to enhance the HMB-HMCC Network ix. Collaborate with MINSAL in the design of more efficient communication mechanisms for the recruitment of donor mothers in the national HMB-HMCC network. x. Generate an inter-institutional work network with Universities and Civil Society Organizations to create spaces for scientific collaboration and research work around the national HMB-HMCC Network. xi. Design, with the support of other actors, a Monitoring, Evaluation, Accountability and Learning System for the national HMB-HMCC network. xii. Negotiate cooperation agreements between CALMA and private companies participating in the HMBHMCC Network, including negotiating new participations through trade union initiatives (following the example of the agreements signed by Santa Ana HMB with textile factories). 12. Recommendations General recommendations i. Share the results of this study with the authorities of MINSAL, the Office of the First Lady of the Republic, ISSS, CONALAM and other strategic actors to interest them in generating cooperative alliances and promoting opportunities to work on initiatives to strengthen the Network of HMBs and HMCCs and to benefit breastfeeding. ii. Disseminate the results of this study with the HMB work teams and their territorial networks for knowledge management, learning, detection of areas for improvement and motivate them to improve the overall performance of the HMB-HMCC Network at the current moment of COVID-19 facing the country. iii. Design a Monitoring, Evaluation, Accountability and Learning system based on the network's operating logic according to the conceptual model in Figure 12-1. iv. This system can be built with the support of a university academic entity and the collaboration of civil society entities specialized in breastfeeding and food security promotion. v. Develop an administrative costing system for the services of the HMB-HMCC network based on the methodology developed for this study, in which not only the associated operational and institutional costs are considered, but also the savings obtained by PBM dosing (savings in the purchase of substitute foods, medications, and hospitalization time in the NICU). 49 Figure 12-1: Basic Structure of an HMB-HMCC Network Monitoring and Evaluation System Phase 0 Donor Mothers Basic data DBM (HMBHMCC Network and Household Collection Traceability of bottles Entry Module Phase 1: DBM Collection Traceability of bottles Shipping to HMB Losses and protocols Phase 2: PBM Production & Dosage Batches selected for processing Efects on Newborns Impacts of the HMB-HMCC Network Baby control in dispensing Follow-up surveys Production Biological cultures Output Control Medical Release Expost control Impact Indicators and Assestments Dosage Captation Module Production Module RESULTS-BASED MONITORING SYSTEM ASSESSMENTS NATIONAL IMPACT EX POST ASSESSMENT On the recruitment of donor mothers (Phase 0): vi. Gradually resume, based on COVID-19 protocols, donor mother recruitment and fidelization initiatives that proved to be successful in past years and support this management with printed and virtual communicational material taking advantage of social networks, as is done by the HMB of San Salvador with its "Support Groups" strategy. 50 vii. Develop a strategy to strengthen the methods for recruiting donor mothers and collecting DBM in the territorial networks of the HMCCs, considering the following activities: Design and implement a characterization and mapping effort of the capacities, experience and skills that the HMB-HMCC Network staff. Based on the mapping, design a training/technical capacity building and awareness program on current operational guidelines. Take advantage of the resources and initiatives that have been developed with CALMA and academic entities for this program. Increase communication actions from the coordination of the three HMBs to improve the recruitment of donor mothers. viii. Characterize and map the capacities, experience and skills of the HMB-HMCC Network staff to identify a support team for the HMB Network coordination to implement improvement and capacity building processes throughout the Network. ix. Implement annually a capacity building program, internships and experience exchanges with the purpose of improving the recruitment of donor mothers in the territorial networks under standardized processes. The competencies of other actors, such as CALMA and academic institutions, can also be used to support this strengthening process. x. Design a communication strategy for the network and specifically to increase the recruitment of donor mothers. This strategy can be supported with cross-sectoral participation to leverage the competencies of institutions and implement new communication strategies that support the functioning of the HMBHMCC Network at the national and community level. Over-capture of DBM (Phase 1): xi. Systematize the UCSF San Martin household care model for replication in other HMCCs that currently lack this modality of DBM collection. xii. Revise the procedures defined by MINSAL to adapt them to the current operating circumstances, concluding a work regulation that minimizes rotations and personnel changes in the HMCCs. xiii. When equipment renovations are scheduled for HMCCs consider replacing and standardizing the use of horizontal freezers for temporary storage of DBM prior to referral to the respective HMB. 51 On PBM processing (Phase 2): xiv. Comprehensively replace the PBM processing equipment plant, given that the current ones have already reached and exceeded their useful life. xv. At the time of replacing the PBM processing equipment: Develop a time, motion and process study when renewing key PBM processing equipment; This study will be the basis for informing the operation and guidelines to improve HMB human resource productivity and evaluate modifications to the institutional Guidelines. Based on the results of the time and motion study, evaluate the convenience of reinforcing the HMB staff with an additional technician specialized in clinical laboratory. xvi. According to the interviews conducted at HMCC and HMB, the amount of losses are lower in facilities with more highly trained staff and less personnel rotations, such as the San Miguel HMB-HMCC Network. xvii. It is important to strengthen staff knowledge and analyze the other factors that condition the discarding of breast milk before processing. xviii. Structuring the protocol for handling laboratory samples for bacteriological cultures using laminar flow chambers. Such a protocol can be developed based on the installation of the equipment available at the HMB of San Salvador that is pending installation. PBM Delivery and Dosing (Phase 3) xix. Make a review of the PBM inventory, control, requirement and prescription procedures among the HMBs so that they are uniform and capable of being digitized as part of the network monitoring and tracking system. xx. Establish in the HMB procedures the follow-up of the evolution of the beneficiary population by creating a file in the HMB with the medical discharge report, the impact of the PBM on health, follow-up after the hospital stay and monitoring of feeding practices with the mother. 52 13. Bibliography i. ACNUR. (2018). Global Strategy for Livelihoods- UNHCR Strategy 2014-2018. Ginebra, Suiza: ACNUR. ii. Argumedo-Zuleta. (2018). Análisis económico 38 • Marzo de 2018. San Salvador: FUSADES. iii. Banco Mundial. (24 de febrero de 2019). https://datos.bancomundial.org/pais/el-salvador iv. CALMA-UNICEF-MINSAL. (2017). Sistematización de la implementación de los bancos de leche humana y centros recolectores en El Salvador. San Salvador: CALMA. v. CEPAL. (2015). CEPAL Adaptación al cambio climático en América Latina y el Caribe. (G. O. Magrin, Ed.) Santiago, Chile: Comisión Económica para América Latina y el Caribe - CEPAL. vi. Conway, C. (1991). Sustainable rural livelihoods: practical concepts for 21st century. Sri Lanka: International Water Management Institute. Obtenido de http://publications.iwmi.org/pdf/H_32821.pdf. vii. Delval, J. (1997). Hoy todos son constructivistas. Cuadernos de Pedagogía N° 257, pág. 78-84. Logroño, España: Fundación DIALNET: Universidad de La Rioja. viii. DIGESTYC. (2018). Encuesta de Hogares de Propósitos Múltiples 2017. San Salvador: Dirección General de Estadística y Censos. ix. FUSADES. (2018). Informe de Coyuntura Social 2017-2018. San Salvador: FUSADES. x. Gutiérrez, P. M. (15 de enero de 2007). “Mapas sociales: método y ejemplos prácticos”. Obtenido de www.preval.org: https://dialnet.unirioja.es/servlet/articulo?codigo=2894735 xi. Luna, F. (2017). Cambio climático en El Salvador: Impactos, respuestas y desafíos para la reducción de la vulnerabilidad, elaborado por (2017). San Salvador: PRISMA. xii. MINSAL. (2017). Lineamientos técnicos para la implementación y operativización de bancos de leche humana y centros recolectores. San Salvador: MINSAL. xiii. MINSAL. (2020). Lineamientos técnicos para el funcionamiento de los HMB-HMCC durante la pandemia COVID19. San Salvador: MINSAL. xiv. OMS. (2002). Nutrición Estrategia mundial para la Alimentación del lactante y del niño pequeño. Ginebra: OMS. xv. Picaud JC, B. R. (2017). Human milk treatment and quality of banked human milk. Clin Perinatol. 2017;44:95--119. Obtenido de https://www.sciencedirect.com/science/article/abs/pii/S0095510816301014?via%3Dihub xvi. PNUD. (2018). Informe sobre Desarrollo Humano El Salvador 2018 ¡Soy Joven! ¿Y ahora qué? San Salvador: PNUD. xvii. Rogers, P. (2017). La Teoría del Cambio (de la Serie Síntesis Metodológicas) . París: UNICEF/ Centro de Investigaciones Innocenti. 53 Databank, Banco Mundial. Obtenido de
0
You can add this document to your study collection(s)
Sign in Available only to authorized usersYou can add this document to your saved list
Sign in Available only to authorized users(For complaints, use another form )