Abstract

It aimed to discuss the limits and potentialities, from the perspective of managers of Hemotherapy/Hemocenter services, for the accomplishment of actions and the relationships between state and municipal VISA agents/teams with the Hemocenters. From a qualitative approach, eight interviews with managing representatives of hemocenters from different states, distributed in the five Brazilian regions, were used for content analysis. The findings showed a limitation in the dialogue between the institutions; staff change and manager turnover; bureaucratic time; decentralized notification; difficult structuring or absence of the Patient Safety Center, such as limitations. As potentialities: VISA’s role as a collaborator in the qualification processes; planning processes constructed in an articulated and collaborative way; collaboration to carry out training and qualification of teams; professional experience of workers from both institutions to understand the routine of services and improve dialogue. Therefore, the limits and potentialities evidenced from this study reflect on the development of actions, responsibilities and dialogue between the services, which must be considered for the elaboration of strategies and development of articulated and integrated work.

Palavras-chave:
Health Surveillance; Blood Banks; Hemotherapy Service

Introduction

In view of the therapeutic use of blood and the positive results in the recovery of patients during the First and Second World Wars, actions to collect and distribute blood were promoted, culminating in the emergence of transfusion services (Santos; Moraes; Coelho, 1991SANTOS, L. A. de C.; MORAES, C.; COELHO, V. S. P. A hemoterapia no Brasil de 64 a 80. Physis. Rio de Janeiro, v. 1, n. 1, p. 161-182, 1991.; Pereima ., 2010PEREIMA, R. S. M. R.; REIBNITZ, K. S.; MARTINI, J. G.; NITSCHKE, R. G. Doação de sangue: solidariedade mecânica versus solidariedade orgânica. Rev. bras. enferm., Brasília, v. 63, n. 2, p. 322-327, abr. 2010.). In the 1940s, the first blood bank appeared in Brazil, a milestone for hemotherapy in the country; nonetheless, until 1964, there was no law or technical regulation for hemotherapy services (Brasil/ANVISA, 2007; Azevedo, 2017AZEVEDO, M. R. B. Hemovigilância dos eventos adversos em um Hospital Público de Palmas - Tocantins. Dissertação (mestrado profissional) - Instituto de Saúde Coletiva. Universidade Federal da Bahia, Salvador, 2017.), and it was only in 1965 that Law nº 4,701/65 was enacted, marking the beginning of sanitary control for hemotherapy (Santos; Moraes; Coelho, 1991; Azevedo, 2017; Brasil, 1965).

In the field of health services, such as hemotherapy services, health surveillance actions (VISA, according to the Portuguese acronym) aim to guarantee patient safety, reduce iatrogenesis, control the risks inherent in the environment and maintain technical quality, by regulating, inspecting and monitoring health service providers (Brasil, 2013), and encompass a broad scope of objects of health interest, which gives them a complex nature, given the heterogeneity of the work processes that are part of this segment (Rozenfeld, 2000ROZENFELD, S. (Org.). Fundamentos da Vigilância Sanitária. Rio de Janeiro: Editora Fiocruz, 2000.). Brazil’s Blood Policy is therefore endowed with technical rules and regulations designed to minimize the risk to blood donors and recipients who have transfusion needs, whether due to hematological diseases or hemotherapy needs, with a view to greater health safety (Souza; Souza, 2018b).

However, few studies have discussed Health Surveillance in Hemotherapy Services. A brief review (Capelato, 2020CAPELATO, P. M. Produção científica sobre Vigilância Sanitária em Serviços de Saúde da Atenção Primária à Saúde e Atenção especializada. Trabalho de Conclusão de Curso - Residência Multiprofissional em Saúde Coletiva com área de concentração em Planejamento e Gestão em Instituto de Saúde Coletiva-Universidade Federal da Bahia. Salvador, Bahia. 2020.) in the Scielo and Lilacs databases, from the period 1999-2019, pointed to publications on the structure of Hemosurveillance and Hemotherapy services (Mota; Freitas; Araújo, 2012MOTA, D. M.; FREITAS, D. R. C.; ARAUJO, W. N. Avaliação do Sistema de Vigilância Sanitária do Sangue em âmbito federal, Brasil, 2007. Ciênc. saúde coletiva, Rio de Janeiro, v. 17, n. 1, p. 191-202, jan. 2012. DOI:https://doi.org/10.1590/S1413-81232012000100021.
https://doi.org/10.1590/S1413-8123201200... ), the health situation of risk control in Hemotherapy services (Silva Junior; Rattner, 2016) and the risk assessment of such services (Silva Junior; Rattner; Martins, 2016), at the national level. In addition, an assessment of the potential risks in Hemotherapy services in the state of Paraná was published more recently (Pavese; Martinez, 2020PAVESE, R.; MARTINEZ, E. Z. Avaliação sanitária dos serviços de hemoterapia do estado do Paraná. R. Saúde Públ., v. 3, n. 1, p. 97-107, jul. 2020.).

There is a need to develop studies that address the issue based on the realities in the country, so that their results can help in the process of developing strategies to improve the safety of blood, blood derivatives and blood components needed for health care. Accordingly, the aim of this article was to discuss the limits and potentialities, from the perspective of managers of Hemotherapy/Hemocenter services, for carrying out actions and the relationships between state and municipal VISA agents/teams and Hemocenters.

Methodological aspects

This is a qualitative study, which is characterized as part of the research “Health Surveillance in Primary Care and Specialized Care health services in Brazilian States” (Souza , 2018aSOUZA, M. K. B. et al. Vigilância Sanitária nos Serviços de Saúde da Atenção Básica e Atenção Especializada em estados brasileiros. Proposta de estudo e pesquisa. Salvador: Instituto de Saúde Coletiva. 2018a.) approved and funded by the National Council for Scientific and Technological Development (CNPq, according to the Portuguese acronym), Universal Notice of the Ministry of Science, Technology and Innovations/National Council for Scientific and Technological Development (MCTIC/CNPq, according to the Portuguese acronym) nº 28/2018.

The states where the refresher courses in Health Planning and Management - “Planeja Sangue” - were held, a product of technical cooperation between the Institute of Collective Health of the Federal University of Bahia (ISC/UFBA, according to the Portuguese acronym) and the General Coordination of Blood and Blood Products of the Ministry of Health (CGSH/MS, according to the Portuguese acronym), constituted the fields of this research. This research used interviews, focus groups and document analysis as data collection and production techniques.

In order to achieve the aim defined in this article, the findings obtained from the interviews conducted (2019-2020) with managers of hemotherapy services were used, according to the script applied to the participants of the research that dealt, among other issues, with how the state VISA acts in the sanitary control of Hemotherapy Services in the state, including its challenges, limits and potentialities.

The research participants were invited through contact with the coordinating hemocenters in the states included in the study. Thus, for this study, a content analysis was carried out involving eight interviews with managers at hemocenters in eight different states distributed across the five Brazilian regions, whose reports are coded by the acronym of the service and numerical sequence (HC01, HC02 [...], HC08).

The analysis was organized based on an initial reading to gather the first impressions obtained from the content of the interviews. After the initial exploratory phase, the data on the limits and potentialities for sanitary control in Hemotherapy services was categorized and interpreted through inferences and by contrasting it with the pertinent literature, in order to carry out content analysis, considering “the possibility that speech has of revealing structural conditions, value systems, norms and symbols [...]” (Minayo, 2014, p. 204).

All participants signed a Free and Informed Consent Form and were informed that they could, at any time, interrupt or withdraw from participating in the research as provided for by the ethical specificities of Resolution nº 466/2012 and Resolution nº 510/2016 (Brasil, 2012; 2016a). This study was approved by the Research Ethics Committee of the Institute of Collective Health of the Federal University of Bahia, under opinions nº 3.423.630 and nº 4.420.180 and CAAE nº 12491019.2.0000.5030.

Results

Based on this work, a set of limits and potentialities reported by the participants was identified. The limitations in carrying out actions and in relationships between VISA agents and managers of Hemotherapy services are displayed in Chart 1.

The findings point to different views on the performance of health surveillance in relation to supervisory actions. Although in some services such actions are seen as collaborative, in order to exert greater pressure on the structuring or organization of the network services (HC01), the perception of limitation in the dialogue between the institutions was identified with the predominance of themes specifically focused on inspection actions (HC01), and the presence of conflict situations was also pointed out, where there was a deterioration in relationships due to sanctions suffered (HC02). In addition, in some situations, it was observed the limitation of a broader relationship of VISA’s role that went beyond supervisory actions (HC01, HC02).

It is noteworthy that the possible limitation of the dialogue between the institutions, where the predominance of surveillance actions with a supervisory nature is assumed, may have contributed to the generation of interferences in the dialogue between the services and, consequently, have hindered the conduct of these actions and contributed to the constitution of frayed personal relationships. It was pointed out by two interviewees that some representatives of VISA present themselves as “sanitary police” during the performance of supervisory actions and that such a posture enhances conflictual relationships and promotes wear and tear between institutions (HC02, HC04). In this context, it is also important to highlight the existence of different approaches, where it was possible to perceive a personification in the individual figure of the subject in an antagonistic way, pointing out the existence of different postures of VISA representatives; and, in this perspective, an absence of standardized conduct among those who performed the supervisory actions, with the perception of overload in the inspections exercised by VISA on Hemotherapy services (HC04, HC07).

Another factor highlighted is related to human capital, where the reduced staff (HC05) and the turnover of professionals within the services act as a factor of tension on the process of continuity of actions, which present specificities inherent to the work processes both within the scope of VISA and in blood banks. Attention should be paid to the fact that the disengagement of employees, due to retirement (HC08) or even migration to other services (HC07), puts pressure on the institutions, allied to this a weakening of the employment relationship, by the adoption of hiring methods that differ from the public tenders that contribute to the turnover of these professionals. In addition, staff changes within the management scope are also pointed out as responsible for ruptures in the continuity of actions and articulations. In this regard, specifically, changes in government may imply changes in management in several spheres, which may reverberate in changes in various spheres of services and cause delays or interruptions in actions (HC04).

Another factor that has an impact on the process of solving demands is the bureaucratic flow required for the systematization and solution of demands. Some of them, for instance, require bidding processes that have specific rites, and their processing requires financial resources and time. These factors can delay or prevent the fulfillment of requests for adjustments, such as the acquisition of equipment and renovations flagged as necessary in notifications of non-conformities (HC02, HC03, HC05, HC06, HC07).

Regarding the actions related to hemosurveillance, technosurveillance and pharmacosurveillance, a frailty in the answers was observed, and it was pointed out that these are carried out by the hemocenters through flows established within specific routines of each service, being pointed out as a factor of frailty in relation to the segmentation of these actions and decentralization with the use of NOTIVISA - Brazilian National System of Notifications for Health Surveillance, with an absence of a dialogued process (HC01, HC07).

Another point observed was the succession of reports of difficulty in structuring or even the absence of implementation of the Patient Safety Center (PSC) (HC01, HC02, HC03, HC04). In view of this, it was considered the possibility that the distancing in the communication processes with the health surveillance services and the fragility in the return of information sent via the system contribute to the weakening of the establishment of the PSC. This is because, in the Hemotherapy services where the relationship with health surveillance was presented in a more dialogued manner, the activities of the PSC were better described and were more structured, in general.

Regarding the set of potentialities, Chart 2 presents facilitating and powerful aspects about the actions and relationships between the agents/teams of the state and municipal VISA, as well as with the managers of the Hemotherapy/Hemocenter services.

By analyzing the accomplishment of health surveillance actions and the relationships between the Health Surveillance agents and the Hemocenters, VISA’s performance was pointed out as a collaborator for the processes of qualification, guidance, advice and detection of non-conformities in order to contribute to the improvement of the quality of care provided by Hematology and Hemotherapy services and the product that is offered to the network (HC01, HC02 [...] HC08).

Regarding the planning actions, it was found that some services perceive their processes as well-structured and these as an instrument for the organization of the service (HC01, HC02, HC05, HC07, HC08). Besides that, in those where there was a perception of the construction of planning in a more articulated and structured way between the management spheres, planning actions were pointed out as potential for strengthening actions both at the local level, with VISA (HC01, HC05, HC07), and at the national level - Ministerial/ANVISA (HC08). In addition, in services where there is dialogue with other instances, such as health surveillance or even with the health department, greater clarity was observed, which expressed a better organization of planning processes with the shared presence between these entities in collegiate spaces for the elaboration of action plans (HC01, HC08).

Joint actions of Hemotherapy services with VISA were also highlighted, such as training and qualification of the teams (HC04, HC07). It is noteworthy that, in the services where there were professionals with experience in both Hemotherapy services and Health Surveillance services, descriptive reports of actions performed in an integrated manner were identified in the respondents’ speech in order to suggest that this experience provides a better understanding of the routines of the services and what would be the vehicles for a more assertive and collaborative dialogue between the services.

Discussion

In health services, risk control refers to operational concepts of which the term “sanitary control” encompasses a set of actions that are within the scope of VISA, and inspection is the act of verifying compliance with sanitary standards (Rozenfeld, 2000ROZENFELD, S. (Org.). Fundamentos da Vigilância Sanitária. Rio de Janeiro: Editora Fiocruz, 2000.). Therefore, such actions are sanitary practices that are based on the protection and defense of health, and sanitary control in health services is a dimension where the environmental, procedural, human or managerial conditions for risk control are established (Goulart; Almeida, 2017GOULART B. N. G. de; ALMEIDA, C. P. B. de. Controle sanitário em serviços de saúde: uma dimensão da universalidade. Rev. Salud Pública. v. 19, n. 2, p. 215-218, 2017.).

In Hematology and Hemotherapy services, the requirements for good practices in the blood cycle are set forth by RDC nº 34/2014 and guided by control and supervisory actions, which are carried out in order to ensure the quality control of processes and products to reduce health risk and thus promote greater transfusion safety (Brasil/ANVISA, 2014a). Such concepts corroborate what was observed in this study when observing the perceptions of participating interviewees about VISA’s actions, in general, as collaborators for the production of a final product with better quality and in terms of reducing risk.

Nevertheless, supervisory actions can sometimes be interpreted in a mistaken and restricted way. According to Rozenfeld (2020, p. 17), the “reduction of surveillance practices to the police power and inspection itself has produced serious distortions”. According to Silva, Costa and Lucchese (2018SILVA, J. A. A.; COSTA, E. A.; LUCCHESE, G. SUS 30 anos: Vigilância Sanitária. Ciência & Saúde Coletiva, v. 23, n. 6, p. 1953-62, 2018., p. 1,954), “health surveillance has the attribute of police power, of an administrative nature, which allows it to limit the exercise of individual rights for the benefit of the public interest” in order to “raise the quality of products and services and adapt productive segments”. In addition, it is inferred that personification in the figure of the subject can occur through the projection event that generates an “entification”. This situation can be observed in the relationship where the individual who acts as a supervisory agent, endowed with the “police power”, is seen by others as the institution.

Another point to be observed is the phenomenon of introjection, where the subject incorporates values or characteristics that they deem valuable in order to feel outstanding among the others (Pinto, 2014PINTO, E. R. Conceitos fundamentais dos métodos projetivos. Ágora (Rio de Janeiro), v. 17, n. 1, p. 135-53, jan/jun. 2014.). In this study, the situations of conflict described between Hemotherapy services and Health Surveillance professionals may be related to the distancing between the institutions, implying the blocking of possible agreements of actions of various natures, such as training and professional qualification activities of the institutions.

The mediation of conflicts between actors in the health sectors is presented as an option in the prevention, management and resolution of divergences where there are frayed relationships (Nascimento, 2020NASCIMENTO, D. M. M. do. Mediação de conflitos na gestão da saúde (médica, clínica e hospitalar): humanização do direito médico. Cad. Ibero-amer. Dir. Sanit. Brasília, v. 9, n. 1, p.170-195, jan-mar., 2020.). Conflicts are supposed to arise from differences in interest between the parties, resulting from the lack of compatibility of values, beliefs or needs of the individuals in conflict (Lima; Campos; Lopes, 2018LIMA, B. G.; CAMPOS, F.; LOPES, C. P. Mediação e conciliação de conflitos na área da saúde. Unisanta Law and Social Science; v. 7, n. 3, 2018. p. 523-533.). In this research, reports of conflicting situations between VISA agents and Hemotherapy service professionals were identified, which has repercussions on the distance between the institutions with communication processes restricted to supervisory situations and frayed relationships between the services.

According to Parisi and Silva (2018SILVA, J. A. A.; COSTA, E. A.; LUCCHESE, G. SUS 30 anos: Vigilância Sanitária. Ciência & Saúde Coletiva, v. 23, n. 6, p. 1953-62, 2018.), the mediation process involves understanding the genesis of the conflict and what factors contribute to its maintenance. The option for conflict mediation, facilitated by an external agent, provides access to narratives and allows a contextualization of disputes, which also enables a better understanding of differences, favors the possibility of reviewing behaviors/postures and grants possible forms of interaction for the prevention, management or solution of the issue. It is assumed that situations of conflict between VISA agents/services and Hemotherapy professionals/services referred to in this study may be related to a weakness in the understanding of the function, limits and routines of each service.

Nevertheless, it was observed that in services where there were professionals with work experience, having worked at some point in VISA and migrated to Hemotherapy services or performed an inverse movement, such experience was presented as a potentiality. In this sense, situations of cooperation between the institutions were reported, with the accomplishment of technical collaboration activities, training and invitations to facilitate lectures and qualification activities for the teams of both services.

Conversely, in the services where the change of personnel was observed as a limitation, there was a concern with the process of continuity of the actions. In services that require technical knowledge with such specificity, staff turnover can lead to disruptions in actions and losses in work construction processes. For Dias, Cordeiro and Gonçalves (2021DIAS, M. M.; CORDEIRO, B. C; GONÇALVES, G. F. Educação permanente aplicada aos profissionais do setor de hemoterapia: uma revisão integrativa. Research, Society and Development, v. 10, n. 1, 2021. p. 1-9., p. 3), the significant learning that is generated by Continuing Health Education (CHE) practices is constituted through the “problematization of work processes” with the incorporation of meaning to what is learned and correlated with daily practices. In this way, processes of change occur in the work practices and in the organization of the institution. In addition, CHE practices are presented as potential contributors to the reduction of the limit indicated by the change of personnel.

The value of human capital, one of the elements considered when analyzing the intellectual capital of an institution, comprises capacity, skills, experiences and knowledge of the processes involved in the dynamics of services (Cordeiro et al., 2017). The adoption of a personnel management policy that values the development of its staff tends to correlate with more productivity and, consequently, with the best product. Conversely, the loss of capital is directly related to the precariousness of work, according to the results evidenced here, which corroborates the statement by Gondim (2018GONDIM, A. A.; PINHEIRO, J. A. M; MENDES, C. F.; NEVES, L. O impacto do processo de precarização laboral em serviços de saúde. Rev. SBPH, Rio de Janeiro, v.21, n. 1, p. 56-73, jun. 2018.) about favoring staff turnover.

Changes in personnel within the management scope are also pointed out in this article as responsible for disruptions in the continuity of actions and in the articulation of services. In addition, changes in the political scenario, such as transitions of governors or mayors, were also presented as factors that can act as triggers for changes in the various spheres of public health services and cause delays or interruptions in actions.

When evaluating issues related to planning processes, well-structured activities and the use of planning practices to support the organization of the service were pointed out as potentialities for some Hemotherapy services. It should be noted that, by definition, according to Paim (2006PAIM, J. S. Planejamento de saúde para não especialistas. In: CAMPOS, G. W. et al. (Org.). Tratado de Saúde Coletiva. São Paulo, Rio de Janeiro: Hucitec; Abrasco, 2006., p. 830), planning is presented as an “element of management”, and can be constituted as a “method, tool or technique” for management and as a “social process” where different subjects take part. Therefore, for the elaboration of the Strategic Planning of the service, organizational guidelines are indispensable and allow the structuring of references for the monitoring of the performance held by the institution, which can be measured by indicators that can be of quality, productivity, capacity and performance.

In this context, the National Program for the Qualification of the Hemonetwork (PNQH, according to the Portuguese acronym) presents itself in an opportune way to increase technical and managerial improvements in Hemotherapy services within the logic of quality management (Brasil, 2016b; Martins; Leister; Santos, 2018MARTINS, J. T.; LEISTER, G. A.; SANTOS, C. M. Gestão da qualidade e avaliação dos serviços de hematologia e hemoterapia na perspectiva no Programa Nacional de Qualificação da Hemorrede. In: SOUZA, M. K. B. (org). Planejamento e Gestão em Saúde: Ccaminhos para o fortalecimento das Hemorredes. Salvador: EDUFBA, p. 89-104, 2018.). The adoption of Strategic Planning by Hemotherapy services favors, therefore, the strengthening of quality in hemotherapy and hematological care (Brasil, 2016b). The Master Plan for Blood and Blood Products, therefore, stands out as a resource to be elaborated, used and updated to instrumentalize the decision-making process in the sanitary control of Hemotherapy services (Brasil/ANVISA, 2007; Sepúlveda; Souza, 2018SEPÚLVEDA, I.; SOUZA, M. K. B. A questão do sangue nos espaços e instrumentos de gestão em municípios da Bahia. Divulgação em Saúde Para Debate, Rio de Janeiro, n. 58, p. 11-22, jul. 2018.). Nonetheless, it should be underlined that planning goes beyond the use of “plans, programs or projects” where they appear as instruments, emphasizing the importance of the participation of various actors in the construction process (Sepúlveda; Souza, 2018, p. 17). The findings of this study corroborate the above, which showed, concomitantly, the understanding of the importance of articulating planning actions and sharing collegiate actions.

Planning instruments provide information that supports decision-making. Nevertheless, there are situations that may require the revision of routines, changes in programming or the need to incorporate new elements that were not previously part of the scope of actions or acquisitions planned for a certain period. As part of their routine, the health services receive visits from VISA technicians who, in the exercise of their supervisory actions, can issue reports with notification of non-conformities and guidance for reorganizing the service, acquiring equipment or making structural adjustments, such as reforms in the physical structure of the institution. However, this research evidences the response time and the availability of financial resources for the service and, consequently, the adequacy of these identified non-conformities did not always occur within the same deadline, thus operating as a stressing factor in the service.

In the findings from this study, the need to attend to adjustments of non-conformities and the possibility of interdiction of the service were pointed out as issues that generate conflict and wear and tear in the relationships between VISA agents and Hemotherapy services. It should also be noted that institutions that have a public legal nature are linked to the State Direct Administration or structured in other models, such as autarchies and foundations that can only carry out the acquisition of consumables or permanent materials or works and services through bidding processes (Brasil, 1993). However, the legal-administrative rites that encompass bidding processes require time and financial resources for their accomplishment and, not necessarily, always achieve success at the end of the contest, and may have their claim failed during the bidding process, either due to failure during the preparation or by the interposition of appeals from suppliers who feel harmed by the design of the product in the process, for instance.

Another point identified was the process of decentralization of notifications. When verifying the process of implementing the decentralization of notifications with VISA, it is necessary to rescue Ministerial Ordinance nº 1,660/2009, which instituted the Notification and Investigation System in Health Surveillance (VIGIPOS, according to the Portuguese acronym) focused on adverse events and technical complaints related to health services and products under sanitary surveillance (Brasil, 2009). Subsequently, through RDC nº 51/2014 (Brasil/ANVISA, 2014b) and Normative Instruction - IN nº 8/2014 (Brasil/ANVISA, 2014c), the Sentinel Network was disciplined as a strategy aimed at obtaining qualified information on the performance of products of sanitary importance by the Brazilian Health Regulatory Agency (ANVISA, according to the Portuguese acronym), with competencies to contribute to the improvement of risk management, provide quality information to support decision-making, report adverse events and technical complaints through the Health Surveillance Notification and Investigation System (NOTIVISA, according to the Portuguese acronym) and, among others, act as a reference for the National Patient Safety Program. Therefore, according to the ANVISA (2015, p. 18), it is the responsibility of HS and other services that perform transfusions to record, investigate and review blood cycle procedures, as well as to make decisions for correction and prevention of non-conformities and to communicate to the health authority in a timely manner.

However, according to a study conducted by Sobral, Göttems and Santana (2020SOBRAL, P. A. S.; GÖTTEMS, L. B. D.; SANTANA, L. A. Hemovigilância e segurança do paciente: análise de reações transfusionais imediatas em idosos. Rev Bras Enferm, v. 73, supl. 3, p. 1-7, 2020. https://doi.org/10.1590/0034-7167-2019-0735.
https://doi.org/10.1590/0034-7167-2019-0... ), it was found that there is underreporting of transfusion reactions and that this is a reality that impairs the performance of health teams, which can lead to risks to the patient’s health. In addition, the process of decentralization of notification actions and use of the NOTIVISA was described in this research as a factor responsible for the weakening and segmentation of health surveillance actions. It should also be noted that the sending of notifications via the system allows a gap in the establishment of dialogue between health and surveillance services where there is no feedback on what is recorded.

It is noteworthy that, in the studies identified by Capelato (2020CAPELATO, P. M. Produção científica sobre Vigilância Sanitária em Serviços de Saúde da Atenção Primária à Saúde e Atenção especializada. Trabalho de Conclusão de Curso - Residência Multiprofissional em Saúde Coletiva com área de concentração em Planejamento e Gestão em Instituto de Saúde Coletiva-Universidade Federal da Bahia. Salvador, Bahia. 2020.), it was observed that, when evaluating the VISA system at the federal level with a focus on Hemosurveillance, standardization and inspection of Hemotherapy services, Mota, Freiras and Araújo (2012MOTA, D. M.; FREITAS, D. R. C.; ARAUJO, W. N. Avaliação do Sistema de Vigilância Sanitária do Sangue em âmbito federal, Brasil, 2007. Ciênc. saúde coletiva, Rio de Janeiro, v. 17, n. 1, p. 191-202, jan. 2012. DOI:https://doi.org/10.1590/S1413-81232012000100021.
https://doi.org/10.1590/S1413-8123201200... , p. 197) observed that the system presented itself with an “ill-defined structure”, but with a “regular operation” and of “acceptable utility” for public health. In turn, Silva Junior and Rattner (2016, p. 136), when seeking to describe the health situation of risk control in Hemotherapy services, evaluated through the Method of Potential Risk Assessment of Hemotherapy Services (MARPSH, according to the Portuguese acronym) records of inspections carried out in 2011 and 2012 and observed the existence of “critical services with compromise to the safety and efficacy of products and services”. Another publication using the MARPSH method concluded that “there are still potential risks that need to be analyzed and addressed” (Silva Junior; Rattner; Martins, 2016, p. 7). It is observed, therefore, that the findings of this study corroborate what the authors brought, having reported the existence of a weakness in this process, which may be related to the fact that the information is confidential and the Hemotherapy services, responsible for the coordination of the blood policy at the state level, need to wait for the communication from VISA to be sent so that hemosurveillance or retrosurveillance actions can be carried out, for instance.

In this study, it was noticed that the Hemotherapy services that showed greater difficulty in dialogue with VISA and the return of notifications registered in the NOTIVISA also presented a process of implementation of the Patient Safety Center in a weaker or even non-existent way. RDC nº 36/2013 should be highlighted, which established the actions for patient safety in health services and, therefore, all health services must adopt actions aimed at patient safety and constitute a Patient Safety Center (PSC) so that a Patient Safety Plan in Health Services is also created. The operation of the PSC has the function of articulating and integrating risk management processes in order to ensure the good practices of health services and disseminate the safety culture (Brasil/ANVISA, 2013).

Another resolution, RDC nº 34/2014, establishes that all health services that perform any activity within the Blood Cycle must meet the requirements of Good Practices of the Blood Cycle and, among them, hemosurveillance actions that concern procedures to increase donor safety (Brasil/ANVISA, 2014a). In addition, in 2015, the guidelines of the Conceptual and Operational Framework for Hemosurveillance were established and in it the guidelines for expanding the scope of hemosurveillance with a focus on the surveillance of adverse events were defined (Brasil, 2015). When evaluating the implementation of a hemosurveillance system, Fernandes (2017FERNANDES, M. F. A. Avaliação da implantação do sistema de hemovigilância no estado de São Paulo (Tese). São Paulo: instituto de Medicina Tropical de são Paulo da universidade de São Paulo; 2017.) observed that, of the 81 hospitals that participated in the research, more than half had a transfusion committee (71.6%) and had a sector dedicated to risk management or patient safety (83.9%). Nevertheless, he pointed out that the underreporting of blood-borne diseases/infections may be responsible for the discrepancy between records when comparing their numbers with the notification records in the National Hemosurveillance System (SNH, according to the Portuguese acronym), which is a situation also cited as problematic in this study.

It is underlined that, in order for transfusions to be successful with the guarantee of patient safety, it is necessary to “produce hemocomponents, implement hemosurveillance, rational use of blood, its correct administration and adequate monitoring of the transfusion act and its consequences” (Pereira, 2017PEREIRA, M. G. A hemovigilância no processo de administração de transfusão de hemocomponente para qualidade e segurança do paciente. 2017. 100f. Dissertação (Mestrado Profissional em Saúde e Tecnologia no Espaço Hospitalar) - Programa de Pós-graduação em Saúde e Tecnologia no espaço Hospitalar, Universidade Federal do Rio de Janeiro, Rio de Janeiro, 2017., p. 86). The findings presented by Pereira (2017) corroborate the findings of this study, which highlights the need for surveillance actions that consider risks inherent to the transfusion act in order to prevent events and reduce damage associated with this therapy. In addition, it is suggested that training and continuing education activities can contribute to the issue of patient safety in cases where blood component transfusions are required.

In this research, training and qualification actions were also pointed out as potentialities of actions carried out in an integrated manner. Accordingly, it is considered that the adoption of CHE actions is therefore a potential collaborator for the solution of the limit pointed out when there is weakness in the PSC. Thus, the importance of the constitution of the PSC should be highlighted, with the proper indication of professionals and responsibility for the accomplishment of the Actions of the Patient Safety Plan in Health Services, including the search to promote a better approximation between Hemotherapy services and VISA, in such a way that doubts about its implementation process are resolved and, thus, the incorporation of the PSC within the routine of actions occurs.

In this sense, it should also be noted that proposals for technological solutions to facilitate the recording of information were identified. A tool aimed at the use and selection of indicators in the various stages of the blood cycle (Feitosa; Ferreira Júnior, 2021FEITOSA, A. C. F.; FERREIRA JÚNIOR, O. C. The use of indicators in the different stages of the cycle of blood: use of selection tool. Jornal Brasileiro de Patologia e Medicina Laboratorial, v. 57, p. e2252021, 2021.) and an integrated computerization model through the use of software for mobile devices and dashboards in order to facilitate the processing of information related to health inspections in Hemotherapy services (Cunha, 2018CUNHA, C. L. Informatização do processo de avaliação de risco sanitário em serviços de hemoterapia. Dissertação (mestrado profissional) - Universidade Federal de Santa Catarina, Centro de Ciências da Saúde, Programa de Pós-Graduação em Informática em Saúde, Florianópolis, 2018.). Since June 2022, the Hemosurveillance Monitoring Panel has been available, which allows quick access to data on adverse events in the blood cycle reported to the National Health Surveillance System (SNVS, according to the Portuguese acronym) (Brasil/ANVISA, 2023). Thus, they are characterized as instruments with potential contribution to improving the quality of Hemotherapy services and greater patient safety.

Final considerations

The results of this study showed limits and potentialities in the actions and relationships between Hemotherapy and Health Surveillance services. The limits were related to communication, availability of resources, structure and work process, while the managers potentially affirmed about the experience of the workers, as well as the collaborative processes for the development and qualification of the work.

Nevertheless, this article brought the perspective of managers of Hemotherapy services, in some states of the country, on the accomplishment of sanitary control actions, highlighting the possibility of reflection on their actions, attributions and responsibilities, as well as on the importance of dialogue with VISA, with a view to providing visibility on issues experienced in daily life and the indication of potentiating actions that can be guided by the improvement of health services.

Finally, new studies are suggested to add to the perception of the other workers of the various Hemotherapy services and of the agents and managers of the Health Surveillance, including the expansion of the field of investigation to other states in Brazil.

Acknowledgments

We would like to thank the National Council for Scientific and Technological Development (CNPq), which funded this study in accordance with the Universal Notice (MCTIC/CNPq) nº 28/2018.

References

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