Review Reports - Lean Six Sigma for Sharps Waste Management and Occupational Biosafety in Emergency Care Units

Round 1

Reviewer 1 Report (Previous Reviewer 1)

Comments and Suggestions for Authors

Dear Authors,

Thank you for the substantial revisions made to your manuscript. You have successfully addressed the core methodological concerns from the previous review round. The repositioning of the study as a rigorous diagnostic and planning exercise, supported by a robust theoretical framework and an honest discussion of limitations, has significantly strengthened the manuscript's scientific soundness and contribution.

The additions of the GUT prioritization matrix, the enhanced methodological justification, the updated references, and the "Highlights" and "Limitations" sections are particularly commendable.

To finalize the manuscript for publication, one essential revision is required:

Major Suggestion for Improvement:

1. Ensure Absolute Narrative Consistency Regarding Study Scope:
A careful, line-by-line revision of the manuscript's language is necessary to ensure every statement accurately reflects that this is a diagnostic, planning, and proposal study, not an implementation and evaluation study. The verbs and phrasing must consistently convey proposal, potential, and planning, rather than observed results from an executed intervention.

Please systematically review the Abstract, Highlights, Results, Discussion, and Conclusions. Replace verbs that imply implementation (e.g., "promoted," "contributed to," "improved," "strengthened") with precise language reflecting the study's actual phase (e.g., "aim to promote," "are designed to contribute to," "proposed to improve," "potential to strengthen").
Examples for correction:
- (Abstract) "The interventions also promoted..." → "The proposed interventions aim to promote..."
- (Conclusions) "These measures contributed to reducing..." → "These proposed measures are designed to reduce..."

Once this precise linguistic adjustment is made to align the narrative perfectly with the excellent diagnostic work and theoretical proposal presented, the manuscript will be ready for acceptance.

Congratulations on a much-improved paper.

Author Response

Dear Reviewer 1,

Below, we present our point-by-point responses to all comments made regarding the

manuscript. To facilitate the review process, the reviewers’ comments are displayed in black, while our responses and justifications are presented in blue.

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 2 Report (Previous Reviewer 2)

Comments and Suggestions for Authors

190–193: It is necessary to specify the data corresponding to the three items described, as they are not visible in Table 1. If Table 1 is based on individual observations, these data should be detailed in the supplementary material.

253–275: The results detailed by ECU should be presented individually in the supplementary material. This will allow justification of the consolidation of the results presented in the manuscript.

285–289: It is essential to specify the checklist used for each ECU, given the mention of their heterogeneity in lines 291–294.

309–329: It is recommended to cite the authors who support the use and validity of the mentioned indicators. Likewise, the methodology should describe in detail the process of evaluation and measurement of these indicators.

333–336: When referring to the literature on the topic, it is essential to include the corresponding bibliographic reference that supports the statement.

There is a contradiction between the statement of improvement in process control (383–386) and the deficiencies described later (412–416). It is necessary to revise and improve the wording to clearly differentiate between the improvement observed during the diagnostic phase and the expected improvement (given the lack of implementation).

476–478 and 538–548: Since the work has not yet been implemented (as stated in the limitations), statements regarding direct impact (organizational climate, motivation, etc.) should be revised. It is suggested that these points be presented as expected benefits, potential impacts, or future hypotheses rather than as conclusive results.

A more appropriate and detailed description of the ECUs studied is required, including critical information for the analysis such as unit size, service volume, type of waste management, and other relevant contextual factors for analytical generalization.

The data are presented collectively, without individual analysis by hospital. It is recommended that the individual results of each ECU be presented in the supplementary material or in an appendix.

A thorough review should be conducted to correct typographical deficiencies and redundancies in the document.

The authors are encouraged to review the manuscript to avoid statements that are not supported by the evidence obtained (especially considering the lack of empirical implementation) and to reduce the length of paragraphs without adequate citation, thereby strengthening scientific rigor.

Comments for author File: Comments.pdf

Author Response

Dear Reviewer 2,

Below, we present our point-by-point responses to all comments made regarding the

manuscript. To facilitate the review process, the reviewers’ comments are displayed in black, while our responses and justifications are presented in blue.

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 3 Report (Previous Reviewer 3)

Comments and Suggestions for Authors

My first suggestion to the authors is to shorten the title, as it is too long.

The highlights are not well written; they should be very brief, with a limited number of characters depending on the journal, and not written in this way as short paragraphs.
I understand that the authors have focused their research on healthcare workers, but it would be necessary to state in the Introduction that, in cases where sharp medical waste ends up in municipal waste and at landfills (which does happen), it can seriously endanger public health. This should also be properly referenced.

I recommend that, when stating the social and economic benefits of proper sharp medical waste management, the authors also highlight the environmental benefits.
How can DMAIC be used to assess ECUs' compliance with RDC, identify the managerial, behavioral, and operational causes of the main non-conformities, and structure low-cost improvement actions that strengthen biosafety and governance in sharps waste management processes? This sentence is formulated as a research question. If this is your main research question, I recommend that you explicitly present it as such in the Introduction.
When the acronym for Emergency Care Units is introduced for the first time, it should be used consistently throughout the rest of the text.
The same applies to the acronym SUS.
After reading your statement, “After developing the 5M matrix, the identified causes were evaluated and prioritized using the GUT method (Gravity, Urgency, and Trend) to determine which failures posed the most significant immediate risk to safety and compliance,” it remains unclear who identified these causes, the authors or the employees. I kindly ask you to clarify this and to clearly explain the observation methodology you used.
It is incorrectly written as Table X; it should be Table 2.
In this sentence, you state that the results are “reinforcing the hypothesis that the observed deficiencies stem less from a lack of physical resources than from gaps in management and continuous monitoring.” However, no hypotheses are explicitly formulated earlier in the manuscript. I recommend that you either:
clearly formulate this as a hypothesis in the Introduction/Methods section, or
rephrase this sentence.
The text does not refer to Table 3; I kindly ask the authors to correct this.
Could the authors clarify how they selected the target deadline in Table 3?
There is no need for title of subsection 4.1, since there are no titles of subsequent subsections such as 4.2 or 4.3.
Given the small number of ECUs investigated, I recommend that the authors emphasize already in the Introduction or Methodology that this is essentially a case study and that the results cannot be statistically generalized.
Line 363 - correct is Table 5.
Given the small number of ECUs, it would be advisable for the authors to provide quantitative data for each individual ECU, rather than only aggregated summaries. This should be done in the Results section.

Author Response

Dear Reviewer 3,

Below, we present our point-by-point responses to all comments made regarding the

manuscript. To facilitate the review process, the reviewers’ comments are displayed in black, while our responses and justifications are presented in blue.

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 4 Report (Previous Reviewer 5)

Comments and Suggestions for Authors

The authors have clarified all the doubts and questions raised. Thank you for considering my suggestions for improvement.

Author Response

Dear Reviewer 4,

Below, we present our point-by-point responses to all comments made regarding the

manuscript. To facilitate the review process, the reviewers’ comments are displayed in black, while our responses and justifications are presented in blue.

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Round 2

Reviewer 2 Report (Previous Reviewer 2)

Comments and Suggestions for Authors

Thank you for addressing the observations.

Author Response

Dear Reviewer 2,

Thank you for evaluating our manuscript. We would like to inform you that all observations were carefully analyzed and duly addressed.

Our responses are presented clearly and highlighted in blue in the attached Rebuttal Letter, allowing for transparent verification of how each point was handled.

We remain at your disposal for any further clarifications.

Sincerely,
Fernando Elemar Vicente dos Anjos

Author Response File: Author Response.pdf

Reviewer 3 Report (Previous Reviewer 3)

Comments and Suggestions for Authors

While appreciating the efforts the authors have made to address the reviewers’ comments and improve their manuscript, I must point out that further improvements are still necessary in the current version:

The highlights are still not well written; Questions are not required in the Highlights section; please remove them and consider reducing the overall number of highlights.
A citation to reference number 6 is missing in the text.
The ECU acronym is still not used consistently throughout the text.
The authors of paper add sentence: "The proposed use of checklists, feedback mechanisms, and recurring training sessions is expected to strengthen process control and may enhance professionals’ sense of self-management and ownership, based on patterns identified during the diagnostic phase and evidence
reported in the literature." Which literature are you referring to? Please cite the relevant scientific sources.
The similar, in the sentence "In addition, improved sharps waste management also generates relevant environmental benefits, as standardized segregation, labeling, and traceability reduce the risk of improper disposal, environmental contamination (...)" Please cite the relevant scientific sources.

Author Response

Dear Reviewer 3,

Thank you for evaluating our manuscript. We would like to inform you that all observations were carefully analyzed and duly addressed.

Our responses are presented clearly and highlighted in blue in the attached Rebuttal Letter, allowing for transparent verification of how each point was handled.

We remain at your disposal for any further clarifications.

Sincerely,
Fernando Elemar Vicente dos Anjos

Author Response File: Author Response.pdf

This manuscript is a resubmission of an earlier submission. The following is a list of the peer review reports and author responses from that submission.

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Dear Authors,

I commend you for the meticulous work in diagnosing the problems in sharps waste management in Brazilian UPAs. The application of the DMAIC methodology is appropriate, and the quality tools were well employed to identify the root causes of the problems.

To strengthen the manuscript, I suggest two main directions:

Empirical Validation (Recommended for Higher Impact): The practical implementation of the proposed improvement plan and the presentation of pre- and post-intervention results would significantly strengthen the scientific contribution of the work, properly closing the DMAIC cycle.
Theoretical Deepening (Viable Alternative): The incorporation of a solid theoretical framework (e.g., Safety Culture Theories, Organizational Learning, or Change Management) would enrich the analysis of the identified behavioral and managerial causes, providing greater depth to the discussion.

Specific observations:

The current conclusions suggest the method's effectiveness; however, as the interventions were not tested, these claims lack empirical support.
The introduction contextualizes the regulatory problem well but would benefit from additional theoretical references.
The tables and figures are clear and well-prepared.

Comments on the Quality of English Language

The manuscript is comprehensible in its current form. However, revisions to grammar, word choice, and sentence structure would improve the fluency and clarity of the narrative. I recommend proofreading by a native speaker or a professional language editing service.

Author Response

Dear Reviewer,

We present in the attached file point-by-point responses to all comments made regarding the manuscript. To facilitate the review process, the reviewers’ comments are displayed in black, while our responses and justifications are presented in blue.

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The document presents an interesting topic, but it is recommended that it include more international literature and further develop the study area, materials, and methods so that readers can follow the sequence in the results and discussion sections.

All methods used for presenting the results and discussions should be described in the methodology section.

Comments for author File: Comments.pdf

Comments on the Quality of English Language

It currently states:
"The paragraphs should be improved; there is redundancy of terms and abbreviations throughout the document.

Emergency Care Units (ECUs) should be defined in the document."

It should read:

"The paragraphs should be improved; there is redundancy of terms and abbreviations throughout the document.

Emergency Care Units (ECUs or UPAs) should be defined in the document."

Author Response

Dear Reviewer,

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

The authors state: “Among these accidents, those caused by sharp materials—such as needles, blades, and catheters—are among the most frequent sources of exposure to biological and chemical agents, requiring preventive policies, strict protocols, and safe handling practices.” Please provide supporting sources for this claim.
My recommendation is that the authors add clearly formulated research questions to the Introduction.
Could the authors provide a more detailed explanation of how the data presented in Table 1 were obtained?
The authors state that they applied the GUT method (Gravity, Urgency, and Trend) to determine which failures posed the greatest risk, and that they conducted a prioritization. Why are these results not presented in the manuscript? The paper needs additional research.
How do the authors justify their small sample of only three Emergency Care Units?
How did the authors develop the Continuous Improvement Plan, particularly the deadlines?
Could the authors provide evidence supporting the claim that periodic training sessions combined with feedback meetings consolidate a culture of shared responsibility among managers and frontline staff?
The authors of the paper state: “The literature emphasizes that…” (line 267). Please specify which sources you are referring to and cite them appropriately.
Table 4 - please provide the selection process of indicators and supporting references.
The Discussion is purely narrative, focusing on comparing the authors’ work with prior studies; it lacks analytical depth. The paper does not include a limitations part.
In the Introduction, the authors announce that they will address the economic implications, the strengthening of biosafety and sustainability, and the human/educational dimensions; however, these themes are not developed in the manuscript.
The Conclusion lacks a part on future research.
The references are not formatted according to the journal’s guidelines, and a total of 17 references is too few for an article.

Author Response

Dear Reviewer,

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 4 Report

Comments and Suggestions for Authors

The paper is well written, comprehensive, and walked me through the concept and application in a very systematic manner.

Author Response

Dear Reviewer,

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf

Reviewer 5 Report

Comments and Suggestions for Authors

The manuscript presents a proposal of scientific interest and significant implications for clinical practice. It is also relevant to occupational and environmental health and risk management. It has a relevant structure and content, is well referenced, and is rigorous and high quality. However, I would suggest some adjustments for improvement (appendix).

Comments for author File: Comments.pdf

Author Response

Dear Reviewer,

We hope that we have successfully addressed all observations and that the revised version of our manuscript may be considered for publication.

Author Response File: Author Response.pdf