title: [Control of potential risk in blood establishments in Brazil: a strategy for regulating authorities].
abstract: Objective To describe the sanitary status of Brazilian blood establishments (BE) assessed by the national health surveillance system in 2013. Method In the present descriptive study, the sanitary profile of BE was assessed using the Blood Establishment Potential Risk Assessment Method (Método de Avaliação de Risco Potencial de Serviços de Hemoterapia, MARPSH), developed by the National Sanitary Surveillance Agency (Anvisa). The MARPSH involves the evaluation of 471 structure and process items to produce an assessment of potential risk associated with critical control points in the blood cycle (vein-to-vein). Based on this assessment, BE are classified into five risk categories: low, medium-low, medium, medium-high, and high. The results were analyzed regarding the type of service (considering all levels, from coordinating centers to collection units), type of financing (public/private) and geographic region. Results Of the existing BE, 1 212 (60%) were assessed in 2013. Of these, 81% met ≥ 70% of the sanitary requirements (satisfactory status, corresponding to medium, medium-low, and low risk categories). Transfusion agencies (hospital units with the role of storing, running compatibility tests between donors and recipients, and transfusing blood components) and public establishments had the highest number of non-conformity structure and process items. Conclusion The use of the MARPSH facilitated the assessment of BE in Brazil and revealed objective opportunities for improvement. These gaps should be addressed by regulating authorities, especially in public services.
authors.forename: João Batista Silva
authors.initials: JB
authors.lastname: Júnior
authors.forename: Daphne
authors.initials: D
authors.lastname: Rattner
authors.forename: Rita de Cássia Azevedo
authors.initials: RC
authors.lastname: Martins
mesh_terms: D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D001938:Brazil; D006801:Humans; D006920:Hygiene / Q000331:legislation & jurisprudence / Q000592:standards; D058996:Quality Improvement; D018570:Risk Assessment