Background
Methods
Instrument
Cross-cultural adaptation
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Step 1 (Translation): Two independent translations of the HCWM–RAT to Brazilian Portuguese (T1 and T2) were made by different certified bilingual professionals, named as Translator A and Translator B: one with previous knowledge of the theme and the other without it. This step was aimed at strengthening the possibility of finding badly formulated questions or linguistic ambiguities [32, 34‐36].
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Step 2 (Translation synthesis): Discussions of translation differences were conducted during a meeting between the translators and the author of this study, using the Nominal Group Technique (NGT) [43] to produce a synthesis of the two translations (T1-2). This process of comparison was carried out taking into consideration the original instrument, the theoretical framework, and the political and regulational context in both languages and cultures. Because the original instrument contained a large number of sections and had a complex structure, a source spreadsheet incorporating translations T1 and T2 was created, to compare the translations, in order to produce a synthesis of the two. In this source spreadsheet, the lines were identified by different background colors, identifying the two translations, while the consensual synthesis was identified by a third color pattern. The main issues and the method for achieving consensus were described in reports produced by the author of this study, using methods recommended in the literature [32].
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Step 3 (Back translation): The back translation was performed to generate another version of the questionnaire (T1-2) in its original language (English). This process was conducted totally blind of the original version by two other different translators, whose mother tongue was English, named here Translator C and Translator D (native English-speaking back-translator, with a Doctorate in Public Health concluded in Brazil) as indicated in the methodology [32].
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Step 4 (Back translation synthesis): The two back translations (BT1 and BT2) were systematized into a consensual version during a meeting following the same methodology explained previously, producing a synthesis (BT1-2).
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Step 5 (Expert judgment): The semantic equivalence (connotative and denotative) [35, 36] was rated by a committee of experts, based on the three versions — the original (HCWM-RAT), T1-2, and BT1-2 — along with respective reports produced in the translation and synthesis steps [32].Representatives of different areas of healthcare waste management made up the committee of experts: researchers, and professionals in the fields of biosafety, hospital quality and management, occupational health, and the physics and hygiene of radiation. Translator D also took part in this group, since he was the only native speaker specialized in public health with a Doctorate in Brazil. There were also members of municipal hospitals, cleaning and hygiene staff, representatives of a municipal garbage collecting company, statistical experts, and representatives of the Sanitary Surveillance Agency, the General Coordination for Environmental Surveillance (Health Ministry) and the Brazilian Environmental Council (Environmental Ministry).A 2-day meeting was conducted, and since the HCWM system to be used is regulated by the government, participation from all aspects of HCW had to be obtained, to contribute positively and productively. The meeting employed a nominal group technique with audio recording [43]. The group evaluated the clarity, coherence and pertinence of all the items and sections in the tool, with respect to the Brazilian context. After analyzing the material and coming to consensus, the committee of experts, along with the author of this study, created the preliminary version to be submitted for a pre-test.
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Step 6 (pre-test): The pre-test was presented to 39 individuals [32], who were selected for their positions as representatives of government or of one of the nine public health care facilities of the Municipality of Niteroi, Rio de Janeiro; at least one individual was selected from each of the nine facilities. An individual could be included in the sample if he or she: performed a function in a governmental sector involved with health or the environment; was a health-care facility director or manager, or a nursing supervisor; was an HCWM commissioner; or was a worker involved with health-care waste handling.
Results
Dimension | Criteria |
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Spatial and characterization of HCF | 1 Geographic and demographic situations |
2 Health-carefacilities (HCF) | |
Capacity building, safety and health | 3 Staff/Health professionals |
Handling steps | 4 Generation |
5 Segregation | |
6 Internal container storage | |
7 Internal storage area | |
8 Internal collection and transportation | |
9 Transportation to external locations | |
10 Treatment | |
11 Final disposal | |
Public policy and budgets | 12 Regulations and guidelines |
13 Policies and budgets | |
Sanitation and waste water | 14 Sanitation and waste water |
Original version | Final Brazilian version | Comments |
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SectionIntroduction | ||
[…] improper management of wastes generated in health care facilities causes direct health impacts on the community, the personnel working in health care facilities, and on the environment. In addition, pollution due to inadequate treatment of waste can cause indirect health effects to the community.
| […] o gerenciamento inadequado dos resíduos gerados pelos Estabelecimentos de Saúde (ES) pode provocar impactos diretos na saúde da coletividade, dos profissionais que trabalham nos ES e no ambiente. Ademais, a poluição oriunda do tratamento inadequado dos resíduos pode causar efeitos indiretos na saúde da coletividade. | The translation “na saúde da coletividade” (on the community), instead of the literal word, “da comunidade” was used because in Brazil the term “community” has the sense of a limited geographical area, inhabited by an indigent population (often referred to as a “favela” or a slum). |
An example of such a plan can be found at the following address:
www.healthcarewaste.org
| Para auxiliar a implantação do Plano de Gerenciamento de Resíduos de Serviços de Saúde (PGRSS), foi elaborado o Manual de Gerenciamento de Resíduos de Serviços de Saúde, lançado pela Anvisa, que igualmente disponibiliza outras orientações relevantes que podem ser encontradas na página do Órgão: www.anvisa.gov.br. | Here, it is stated that the Brazilian Health Surveillance Agency (Anvisa) has developed a handbook to help implement the Health-care Waste Management Plan (HCWMP). The professional is invited to access the electronic page of the Agency, where other guidelines are also offered. |
SectionGlossary | ||
Incineration - The controlled burning of solid, liquid or gaseous wastes to produce gases and residues containing little or no combustible material.
| Incineração - Queima controlada de materiais em temperaturas acima de 800 °C, na presença de oxigênio, sendo os produtos finais desta queima, quando completa: dióxido de carbono, vapor d'água e cinzas | As suggested by the experts, the definition given by current Brazilian regulations was maintained: As stated by the Ministry of Environment, incineration is any process that applies temperatures above 800 °C, in the presence of oxygen, generating carbon dioxide, water vapor and ashes. A consensus was attained that this is not derived from the meaning given by the original version. |
Pharmaceutical waste - Consisting of/or containing pharmaceuticals. [Includes: pharmaceuticals expired, no longer needed; their containers, items contaminated by or containing pharmaceuticals (bottles, boxes…)].
| Resíduo químico-farmacêutico - Consiste de/ou contém produtos farmacêuticos, incluindo medicamentos (com validade vencida ou não mais necessários) e seus recipientes quando contaminados. Regulamentados como uma subcategoria do Grupo B (Resolução RDC ANVISA n° 306/04 e CONAMA n° 358/05) são aqueles caracterizados nos itens 11.11 e 11.12 da RDC Anvisa n° 306/04 | As suggested by the target professionals (from the field test) and the experts, the terminology given by the Brazilian regulations and requirements was adopted. in Brazil, pharmaceutical wastes constitute a sub-category in the Group B (Chemical Residues) (Anvisa 306/04 and Conama358/05). Therefore, besides describing the sub-category, the item indicates regulations and their requirements for identifying medicines that are subject to special control. It is understood that this does not derive from the meaning (waste and classification) given by the original version. |
Radioactive health-care waste - Consisting of/or containing radioactive substances. [Includes: unused liquids from radiotherapy or laboratory research; contaminated glassware, packages or absorbent paper; urine and excreta from patients treated or pre-tested with unsealed radionuclides; sealed sources].
| Rejeito radioativo - materiais resultantes de atividades humanas que contenham radionuclídeos (não selados) em quantidades superiores aos limites de isenção especificados nas normas da Comissão Nacional de Energia Nuclear (CNEN) e para os quais a reutilização é imprópria ou não prevista. | The translation that expresses the concept accepted and adopted by the Brazilian National Nuclear Energy Commission (Cnen) was maintained. The term “waste” is translated as a “Rejeito” (reject) (something that cannot be reused or recycled), instead of waste (something that can be reused, recycled or transformed - for energy). The radioactive reject is described as resulting from activities that use any kind of radionuclide (unsealed) above the amounts considered as improper for reuse by CNEN. |
Recycling - A term embracing the recovery and reuse of scrap or waste material for manufacturing or other purposes.
| Reciclagem - Processo de transformação dos resíduos sólidos que envolve a alteração de suas propriedades físicas, físico-químicas ou biológicas, com vistas à transformação em insumos ou novos produtos. | The definition given by the current regulations (as mentioned above) was maintained. Recycling was described as a biological, chemical or physical transformation process, resulting in new products or raw materials (“cradle to grave” or “cradle to cradle”). It is understood that this encompasses the term and meaning given by the original version. |
Risk - Probability that a hazard will cause harm and the severity of that harm.
| Risco à saúde - probabilidade da ocorrência de efeitos adversos à saúde, decorrentes da exposição humana a agentes físicos, químicos, de acidente (especialmente relacionados aos perfurocortantes) e biológicos | Risk is described as the probability of the occurrence of adverse effects to health, resulting from human exposure to physical, chemical or biological agents. In the case of health care wastes, sharp objects are particularly important. |
Safety (sharps) box - A puncture proof/liquid proof container designed to hold used sharps safely during disposal and destruction.
| Recipientes para acondicionamento de perfurocortantes - recipientes rígidos, resistentes à punctura, ruptura e vazamento, com tampa e devidamente identificados, atendendo aos parâmetros referenciados na norma NBR 13853:1997 da Associação Brasileira de Normas Técnicas (ABNT-NBR) | This item describes the characteristics of the safety boxes for sharps (perfurocortantes). It is warned that the box has to be resistant to perforation, disruption and leaks, and should have a cap and identification. It also has to display conformity to the Brazilian Standards (ABNT-NBR 13853:1997). |
Sharps - Sharps are a subcategory of infectious health care waste and include objects that are sharp and can cause injuries.[Includes: syringe needles, scalpels, infusion sets, knives, blades, broken glass].
| Perfurocortantes - Materiais perfurocortantes ou escarificantes, tais como: Lâminas de barbear, agulhas, escalpes, ampolas de vidro, brocas, limas endodônticas, pontas diamantadas, lâminas de bisturi, lancetas; tubos capilares; micropipetas; lâminas e lamínulas; espátulas; e todos os utensílios de vidro quebrados no laboratório (pipetas, tubos de coleta sanguínea e placas de Petri) e outros similares | In Brazil, sharps are categorized as Group E - Perfurocortantes (Anvisa n° 306/04 and Conama n° 358/05). In the regulations, sharps are described as materials or objects with sharp edges, sharp tips or rigid snags able to produce cuts or to perforate human skin. Sharps can be razor blades, needles, scalpels, shattered glassware, lancets, capillary tubes, micropipettes, microscope slides, cover slips, spatulas, or odontological instruments. |
Waste management - All the activities - administrative and operational - involved in the handling, treatment, conditioning, storage, transportation and disposal of waste.
| Gerenciamento de resíduos - Constitui-se em um conjunto de procedimentos de gestão, planejados e implementados a partir de bases científicas e técnicas, normativas e legais, com o objetivo de minimizar a produção de resíduos e proporcionar aos resíduos gerados, um encaminhamento seguro, de forma eficiente, visando à proteção dos trabalhadores, a preservação da saúde pública, dos recursos naturais e do meio ambiente | The current Brazilian regulatory definition was maintained. Waste management is described as a group of management procedures, scientifically supported, based on legal regulations and standards, aiming to reduce these byproducts and give them an adequate and safe fate. It is further explained that the aim of waste management is to protect workers and to preserve public health, natural resources and the environment. |
Final brazilian version | Comments/description |
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Terms | |
Resíduos similares ao RSU - Resíduos que se supõe não apresentam risco biológico, químico, de acidente com perfurocortantes ou físico (relativos aos rejeitos radioativos), à saúde ou ao meio ambiente, podendo ser equiparados aos resíduos domiciliares | According to the experts, the term “domestic waste” applied in the original version does not exist in the Brazilian regulation, but the closest applicable term is “similar to urban waste” (RSU), These residues do not present any significant risk to human health or the environment. |
Célula especial de RSS - Consiste na disposição dos RSS em locais que observem os critérios mínimos estabelecidos pela Resolução do Conselho Nacional de Meio Ambiente, n°. 358/2005 | Existing conditions for final HCW disposal in some regions of Brazil. A special cell for the disposal of HCW is a location for the destination of wastes, following the criteria established in the Conama n° 358/05 Act. |
Armazenamento temporário (interno) - Consiste na guarda temporária dos recipientes contendo os resíduos já acondicionados, em local próximo aos pontos de geração, visando agilizar a coleta dentro do estabelecimento e otimizar o deslocamento entre os pontos geradores e o ponto destinado à apresentação para coleta externa | This term is given by the Brazilian regulations (Anvisa n° 306/04) and adopted requirements. Internal temporary storage is a site abutting the location of residue generation, where the residues are transitorily stored in labeled containers. This is a restricted area that aims to facilitate the collection and its transportation to the final destination. |
Transporte interno - Consiste no traslado dos resíduos dos pontos de geração até local destinado ao armazenamento temporário ou armazenamento externo com a finalidade de apresentação para a coleta | This term is in accordance with the Brazilian regulations. Internal transportation is the collection of residues within the unit and its routing to internal temporary storage (see previous item). |
Destinação final - Processo decisório no manejo de resíduos que inclui as etapas de tratamento e disposição final. | The term “destination” encompasses the decision making about the handling of HCW, its treatment and final destination, or recycling and reuse where applicable (in agreement with the specialists and target professionals – the HCW management staff). |
Acronyms | |
IBGE - Instituto Brasileiro de Geografia e Estatística; SNIC - Sistema Nacional de Informações das Cidades; CNES - Cadastro Nacional de Estabelecimentos de Saúde; CCIH - Comissão de Controle de Infecção Hospitalar; SESMT - Serviço Especializado em Engenharia de Segurança e Medicina do Trabalho; | IBGE, SNIS and CNES refer to Brazilian databases that must be consulted in order to answer certain items: Criterion 1 – Geographical and Demographic Situation and Criterion 2 – Health-Care Facilities (HCF). Both criteria concern the “location and characterization of HCF”. IBGE is the main demographic information provider, because it is responsible for the Brazilian Census, gathering social, economic and administrative data; SNIS gathers information on management of water services and solid residue; CNES is responsible for quantitative information on the HCF, respective locations/addresses, data on available infra-structure, type of health services provided, specialized health services, inpatient beds and health professionals; CCIH is composed of a team of graduated health professionals, formally designated for hospital infection control; SESMT is regulated by a Brazilian Standard for the prevention of occupational accidents and diseases. Depending on the size of the unit and the number of employees, the SESMT team must be composed of one labor-safety physician, one labor-safety nurse, one labor-safety nurse technician, one labor-safety engineer and one labor-safety technician. |
Assessment Requirements legend (data qualitative [Q]) | |
Não possui conhecimento algum sobre os riscos oferecidos pelos RSS às pessoas que os manuseiam: Inexistente = 0. Sabe que os resíduos oferecem riscos, todavia não sabe esclacer como ou o porquê: Crítico (baixo) = 1. Possui conhecimento contido na opção 1 e sabe que precisa, por exemplo, usar EPI/EPC, mas não o porquê e/ou se este é adequado: Insuficiente = 2. Possui conhecimento contido na opção 2 e compreende a adequação e importância de práticas de prevenção de riscos: Satisfatório = 3. Possui conhecimento contido na opção 3 e sabe como reagir frente à situação de risco ou acidente (tipo reativo): Bom = 4. Possui conhecimento contido na opção 4, mas também sabe como prevenir e é capaz de orientar quanto às práticas de manejo frente aos riscos oferecidos pelos RSS (tipo pró-ativo): Excelente = 5 | No criteria have been attributed for [Q] in the original version – Item 304 (staff for HCW awareness: awareness of risks of person(s) handling HCW?). Instead of literal translation, the term “conhecimento” (awareness) was applied because regulations in Brazil enforce HCW generators to promote a continuous education program for the staff managing wastes. Thus, the following criteria have been created for the Brazilian version: “nonexistent = 0” – The staff has no knowledge about any of the risks presented by HCW; “critical (low) = 1” – The staff knows that waste presents risks, but cannot explain how or why; ‘Insufficient - 2’- The staff has the knowledge contained in option 1 and knows the need, for example, for wearing individual or collective protective equipment (EPI or EPC), but they do not know the reason why or whether is it adequate; “satisfactory - 3” - The staff has the knowledge contained in option 2 and understands the adequacy and importance of risk-prevention options; “good - 4” - The staff has the knowledge contained in option 3 and knows how to react when facing a risk/accident situation (reactive type); “excellent - 5” - The staff has the knowledge contained in option 4, and also cares about prevention and is capable of guiding others in practices for managing the risks presented by HCW (pro-active type) |
Original | Final brazilian version | Comments |
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200 - health care facility (HCF): which category is it (are they)?
[1] ambulant service; [2] (sub-)district hospital | Estabelecimento de saúde (ES): Qual é o tipo do estabelecimento e a que nível de hierarquia pertence? 1] ES para atenção básica; [2] ES de média complexidade; [3] ES de alta complexidade | The terms “type” (tipo) and “level hierarchy” (“nível de hierarquia”) are used in the Brazilian database (CNES) to register HCF to operationalize the Informational Systems in Health. The HCF “type” is defined based on the professional activities and the services offered to a population. The “hierarchy level” indicates the degree of complexity of services provided (basic health assistance, medium and high complexity). |
201 - HCF which type is it (are they)? [1] public; [2] private | ES – De que natureza é? [1] público; [2] privado; [3] outros (especificar) | In the Brazilian database (CNES) the term “nature” (“natureza”) defines the origin of the organization share capital and the HCF administrative link. Option 3 “others (specify)” makes possible the identification of the different administrative conditions found in Brazil. |
401 - domestic waste: quantity produced/day (estimated, in kg or litres) | resíduos similares aos sólidos urbanos (RSU): quantidade gerada por dia (estimativa, em kg ou litros) | According to experts the term “similar to urban waste” (RSU) is the closest term applicable, for Brazilian culture. This item refers to the quantity of waste generated per day that is capable of being recycled or reused. |
404 - anatomic waste: quantity produced/day (estimated, in kg or litres) | peças anatômicas: quantidade gerada por dia/semana (estimativa, em kg ou litros) | The term “anatomic waste” was changed to “peças anatômicas” because in the target culture the term “waste” has a negative connotation (equivalent to “garbage”), which would be considered offensive when applied to human body organs or parts. The term “produced” denotes the interest in conceiving a product. The use of the word “gerada” gives the sense of a byproduct that results from any activity or procedure and that has no use. In the target culture HCW is generated, not produced. |
405 - pharmaceutical waste: quantity produced/day (estimated, in kg) | Resíduo químico-farmacêutico: quantidade gerada por dia/semana (estimativa, em kg ou litros) | This item uses a terminology (“químico-farmacêutico”) suggested by the target population and the experts’ committee, to accommodate the difference in waste classification. Since “pharmaceutical” is not a Brazilian waste category, classifying such waste simply as category B, “chemicals” would include more than just pharmaceutical waste. This item can apply to the amount of pharmaceutical waste generated. |
501 - needle stick injuries: how many cases reported in the past 12 months | ferimentos com perfurocortantes: quantos casos foram relatados nos últimos 12 meses? | This item uses the terminology used in Brazilian regulations (Anvisa n° 306/04 and Conama n° 358/05) to refer to Group E – “Perfurocortantes” waste. This item asks about the number of accidents that occurred during a year. |
900 - transport services: are there any control measures? [0] none; [1] transport form; [2] other (specify) | serviços de transporte: há alguma medida de controle? [0] nenhuma; [1] forma de transporte; [2] emissão de documento de manifesto, CADRI,…; [3] outro (especificar) | In order to identify the measures of control used by the HCW transporters, two document examples were inserted: “manifesto” (waste transportation manifesto, used in the state of Rio de Janeiro) and “CADRI” (certificate of transportation of environmental interest waste, used in São Paulo state) as an option. These documents consist of legal ways to control and monitor the waste transported to treatment and disposal sites licensed by environmental organizations. |
1007 - domestic waste: how is it generally treated? | resíduos similares aos RSU: geralmente, como são tratados (manejados - ogânico e recicláveis)? | In this item, a term in parenthesis, suggested by the experts’ committee and the target population during the field test, was included. In Brazil, the term “treated” is not applied to the category of domestic waste, which is sent to reprocessing. In order to preserve semantic equivalence, the term “treated” was changed to the “way of handling” “similar to urban waste” (RSU) (“manejo – orgânico e recicláveis”). |
1202 - national HCWM regulations: does their application cause any problems ? | regulamentações nacionais para GRSS: a aplicação da regulamentação gera algum tipo de situação-problema? | Suggestion of the target population (during the field test) and the experts’ committee: In the Brazilian cultural context, the word “problem” relates to a negative condition obtained by following the regulation. Hence, the term was changed to “issue” (“situação-problema”). In the re-test this item was evaluated as capable of allowing conflicts to emerge during HCWM regulations application. |