Gestión de la calidad en los Bancos de Leche Humana: revisión de alcance

Fogliano, Rosana Rodrigues Figueira; Bohomol, Elena; Schveitzer, Mariana Cabral; Coca, Kelly Pereira; Abrão, Ana Cristina Freitas de Vilhena

doi:10.1590/0034-7167-2019-0640

Brasil

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REVIEW • Rev. Bras. Enferm. 73 (suppl 6) • 2020 • https://doi.org/10.1590/0034-7167-2019-0640 linkcopiar

Gestión de la calidad en los Bancos de Leche Humana: revisión de alcance

Autoría SCIMAGO INSTITUTIONS RANKINGS

RESUMEN

Objetivos: identificar las principales intervenciones de gestión de la calidad utilizadas por los profesionales que trabajan en los Bancos de Leche Humana.

Métodos: revisión del alcance realizada en las bases de datos de tesis PubMed, BVS, Scopus, SciELO, CAPES y Google Scholar. Se incluyeron estudios primarios que abordan estrategias de mejora de la calidad para mejorar los procesos del Banco de Leche en portugués, inglés y español.

Resultados: la búsqueda totalizó 192 producciones científicas, de las cuales 17 cumplieron el objetivo del estudio y los criterios de inclusión. Las principales intervenciones de gestión de la calidad utilizadas en Bancos de Leche Humanas abordaron herramientas para la mejora continua, con seis destinadas a mejorar los procesos, una para evitar errores y fallas y dos para lograr un monitoreo continuo.

Consideraciones finales: las herramientas utilizadas por los profesionales que trabajan en los Bancos de Leche Humana han demostrado su eficacia en la gestión de la calidad de los servicios.

Descriptores: Bancos de Leche; Gestión de la Calidad; Administración de los Servicios de Salud; Revisión; Enfermería

Authors	Title	Country	Journal	Year
Wesolowska A, Sinkiewicz-Darol E, Barbarska O, Bernatowicz-Lojko U, Borszewska-Kornacka MK, van Goudoever JB⁽¹⁴⁾	Innovative Techniques of Processing Human Milk to Preserve Key Components	Poland	Nutrients	2019
Hartmann BT⁽¹⁵⁾	Ensuring Safety in Donor Human Milk Banking in Neonatal Intensive Care	Australia	Clinics in Perinatology	2017
Peila C, Emmerik NE, Giribaldi M, et al.⁽¹⁶⁾	Human Milk Processing: A Systematic Review of Innovative Techniques to Ensure the Safety and Quality of Donor Milk	Italy	Journal of Pediatric Gastroenterology & Nutrition	2017
Grazziotin et al.⁽¹⁷⁾	Analysis of the Storage Methods for Raw Human Milk from Mothers with Infants Admitted to a Neonatal Intensive Care Unit, According to Brazilian Regulations	Brazil	Journal of Human Lactation	2016
Naicker M, Coutsoudis A, Israel-Ballard K, Chaudhri R, Perin N, Mlisana K.⁽¹⁸⁾	Demonstrating the efficacy of the FoneAstra pasteurization monitor for human milk pasteurization in resourcelimited settings	South Africa	Breastfeeding Medicine	2015
De Nisi G, Moro GE, Arslanoglu S, Ambruzzi AM, Biasini A, Profeti C, et al.⁽¹⁹⁾	Survey of Italian human milk banks	Italy	Journal of Human Lactation	2015
ME Maes, MT Possamai, MG Assoler, FAH Sardá⁽²⁰⁾	Sistema HACCP em banco de leite humano	Brazil	Higiene Alimentar	2015
Menezes G, de Lima-Cavalcanti L, de Morais-Oliveira AM, Costa-Pinto Rde M, Steffen-Abdallah VO⁽²¹⁾	Evaluation of home collection performed by a human milk bank in a university hospital in Brazil	Brazil	Salud Publica de Mexico	2014
Brownell EA, Lussier MM, Herson VC, Hagadorn JI, Marinelli KA⁽²²⁾	Donor human milk bank data collection in north America: an assessment of current status and future needs	United States	Journal of Human Lactation	2014
Spatz, D. L., Schmidt, K. J. & Kinzler, S⁽²³⁾	Implementation of a human milk management center	United States	Advances in Neonatal Care	2014
Carroll, K⁽²⁴⁾	Body dirt or liquid gold? How the 'safety' of donated breastmilk is constructed for use in neonatal intensive care	United States	Social Studies of Science	2014
Vieczorek, A., Wolff, L.⁽²⁵⁾	Evaluation of Human Milk Banks in Paraná - Br: a comparative study	Brazil	Online Brazilian Journal of Nursing	2012
Torrezan AC⁽²⁶⁾	Gestão do processo assistencial e processos de Banco de leite	Brazil	Online Master's Dissertation	2011
Grazziotin AL, Grazziotin MCB, Letti LAJ⁽²⁷⁾	Disposal of human milk donated to a human milk bank before and after measures to reduce the amount of milk unsuitable for consumption	Brazil	Jornal de pediatria	2010
Silva JHF⁽²⁸⁾	Inovações tecnológicas para uma estratégia de qualificação dos produtos e dos processos de trabalho em Bancos de Leite Humano: o sistema de gerenciamento BLMWEB	Brazil	Master's Dissertation	2009
Silva ER, Abdallah VOS, Oliveira AMM⁽²⁹⁾	Qualidade microbiológica do leite humano ordenhado no domicílio: eficácia de uma educational action	Brazil	5^th Academic Week.Universidade Federal de Uberlândia	2008
Costa ACM, Pereira DCA, Silva JAR, Neto JPS, Britto MHSS⁽³⁰⁾	Avaliação da qualidade dos bancos de leite humano no município de São Luís- MA, no período de abril a junho de 2003	Brazil	UFMA University Hospital Journal	2003

Authors	Objectives	Improvement interventions	Outcomes
Wesolowska et al., 2019⁽¹⁴⁾	To compare HM pasteurization methods to improve the safety and quality of donated milk.	Critical analysis	HPP and ultraviolet-C irradiation methods seem to minimize losses as a result of HM processing.
Hartmann, 2017⁽¹⁵⁾	To assess the risks and benefits for HMB donors and recipients using a systematic method.	Risk management - HACCP	Potential hazards and benefits are identified at each stage of HMB processes, and the minimum acceptable standard for safe practice is defined.
Peila et al., 2017⁽¹⁶⁾	To assess the evidence on the effectiveness of new pasteurization techniques on the quality and safety of HM	Critical analysis	The HTST method showed equivalence to the standard pasteurization method, guaranteeing the microbiological safety of HM.
Grazziotin et al., 2016⁽¹⁷⁾	To assess the evidence on the raw HM storage protocol according to Brazilian regulations.	Critical analysis	The methods of storage in refrigeration (5°C/12 hours) and freezing (20°C/15 days) were validated and the energy content of milk was preserved.
Naicker et al., 2015⁽¹⁸⁾	To assess the safety and effectiveness of a mobile pasteurization monitor, FoneAstra, based on Smartphone, as a quality control system for the pasteurization process.	Information technology	None of the samples pasteurized using FoneAstra showed bacterial growth. The innovative tool proved to be safe, effective and low cost for HM pasteurization.
De Nisi et al., 2015⁽¹⁹⁾	To compare the operating procedures of 28 Italian HMB to identify areas of strength and improvement.	Benchmarking	Divergence in the structure (number of hours worked, number of rooms and number of equipment), in the selection processes and mandatory microbiological control.
ME Maes et al., 2015⁽²⁰⁾	To manage risk and control food safety hazards at HMB.	Risk management - HACCP	The critical points were identified: 6 prevented (CCPp), 4 eliminated (CCPe) and 1 reduced (CCPr), which made corrective actions possible.
Menezes et al., 2014⁽²¹⁾	To assess home collection and transport of raw HM during home visits.	Checklist	Weaknesses in the collection process were identified, such as hair protection (93.8%), hand hygiene (83.3%), nail care (87.5%) and neglecting the first drops (33.3%).
Brownell et al., 2014⁽²²⁾	To monitor data from HMBANA belonging to HMBANA, on the characteristics of the donor and donated milk, the feasibility and the interest in participating in a central registry.	Information technology	There was no uniformity in the data collected. A lack of standardization and transparency of information was identified.
Spatz et al., 2014⁽²³⁾	To analyze the key activities in the implementation of an HM management center in a children's hospital.	Flow mapping	Structural weaknesses, the need to improve processes, change in local culture, training of teams and periodic assessment of results were identified.
Carroll, 2014⁽²⁴⁾	To draw the flow of the donated HM of two HMB, from selection to distribution and assess the the process safety.	Flow mapping	The variety of practices and security process in the selection and education of donors, pasteurization and microbiological analysis of the HM between the two HMB were identified.
Vieczorek & Wolff, 2012⁽²⁵⁾	To compare the structure and processes of 8 HMB paranaense based on RDC 171/2006 and ANVISA's HMB operating manual.	Benchmarking	The weak and strong points in the eight HMB were identified. The percentage of compliance ranged from 72 to 85% and non-compliance showed an average of 21%.
Torrezan, 2011⁽²⁶⁾	To implement the Process Management methodology in HM assistance and processing activities.	Flow mapping PDCA Benchmarking	All stages were known and an action plan to improve and monitor all processes was implemented.
Grazziotin et al., 2010⁽²⁷⁾	To assess the causes of disposal of the donated HM and the impact of the implemented measures.	Checklist	The causes of disposal were identified and showed a positive impact in reducing the volume of discarded donated milk.
Silva, 2009⁽²⁸⁾	To know the technological innovations produced by the HMBWEB system in the qualification of HMB performance.	Information system	Construction of indicators that qualify HMB management, processes and procedures.
Silva et al., 2008⁽²⁹⁾	To compare the physical-chemical and microbiological quality of raw HM at home and at HMB before and after a new educational action.	Educational action	There was no improvement in relation to Dornic acidity and microbiological analysis after educational actions.
Costa et al., 2003⁽³⁰⁾	To compare the structure, processes and results of two HMB in the city of São Luís, state of Maranhão.	Benchmarking	Divergences were identified regarding the physical, organizational and process control structures that compromise the quality of the product.

Tools/ Interventions	HMB process	Improvements achieved
Checklist⁽²¹^,²⁷⁾	Raw HM collection and transport	Improvement of processes
Checklist⁽²¹^,²⁷⁾	Raw HM selection	Improvement of processes
Educational action⁽²⁹⁾	HM collection	Improvement of processes
Critical analysis⁽¹⁴^,¹⁶^-¹⁷⁾	Raw HM storage	Improvement of processes
Critical analysis⁽¹⁴^,¹⁶^-¹⁷⁾	Pasteurization	Improvement of processes
Information technology⁽¹⁸^,²²^,²⁸⁾	Pasteurization	Continuous monitoring of results
Information technology⁽¹⁸^,²²^,²⁸⁾	All processes	Continuous monitoring of results
Flow mapping⁽²³^-²⁴^,²⁶⁾	All processes	Continuous monitoring of results
HACCP⁽¹⁵^,²⁰⁾	All processes	Prevent errors and failures

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Associação Brasileira de Enfermagem SGA Norte Quadra 603 Conj. "B" - Av. L2 Norte 70830-102 Brasília, DF, Brasil, Tel.: (55 61) 3226-0653, Fax: (55 61) 3225-4473 - Brasília - DF - Brazil
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[TFN1] Note: ANVISA - Brazilian National Health Surveillance Agency; HACCP - Hazard Analysis and Critical Control Points; HMB - Human Milk Bank; HMBWEB - Human Milk Bank Management and Production System; HMBANA - Human Milk Banking Association of North America; HoP - Holder Pasteurization; HTST - High-Temperature Short-Time; HPP - High Pressure Processing: HM - Human Milk; CCP - Critical Control Point; PDCA - Plan, Do, Check, Action; DRC - ANVISA's Board Resolution; NICU - Neonatal Intensive Care Unit.