PONE-D-24-51452Risk Management in POCT Blood Glucose Monitoring: FMEA Approach Aligned with ISO 15189:2022PLOS ONE

Dear Dr. Xia,

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Vittorio Sambri, M.D., Ph.D.

Academic Editor

PLOS ONE

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Additional Editor Comments:

In detail, your manuscript has been evaluated by two experts in the field of the use of POCT and bio

th found your study interesting. I fully agree with their suggestions and I encourage you to take into consideration their suggestion in oprder to improve the quality and value of your paper.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: No

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: I Don't Know

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Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The use of POCT systems in laboratory medicine is increasingly widespread.

Having correct and rapid laboratory data brings a great advantage to the clinician. The manuscript analyzes the critical issues of these systems and provides useful information. It's a good article.

Reviewer #2: General: Well written

Specific:

Line 29: ”..in clinical settings….” – however, the study was not conducted in a clinical setting - but in a clinical laboratory setting (line 111), which can only simulated a “real” clinical setting. So, the study does not reflect “real life” POCT. This should be clarified and discussed. Clearly, a risk assessment conducted by certified laboratory staff I a clinical laboratory setting is different from a risk assessment in a real clinical setting (e.g., in an ER).

Line 141 / Table1: Probability – the differences should be described – are the different probabilities based on actual frequencies (e.g., 10-6, etc) or purely descriptive? Severity: The description of the five different severity levels should be included – e.g., Catastrophic: Is the definition of this severity “Death or life-threatening injury or illness” – or?

Line 154-159: “Inadequate” and “insufficient” appears several places. What is the difference?

Line 161 / Table 2: Are the described probabilities based on actual observations / data – or estimates?

Line 161 / Table 2: You mention “validation” on several occasions. Do you mean “verification”?

Line 161 / Table 2 / Analytical-Data Management: The implemented risk control measure is “Patient information and test results are entered manually and verified”. Why not use scanning of barcodes and integration with LIS? This will reduce / remove human errors?

Line 181 / Table 3 / 2. Insufficient personnel training: The implemented risk control measure is “IT driven” for Peking and “Manual tracking” for Wuhan. Why different? Why not implement IT driven in Wuhan also?

Line 181 / Table 3 / 5. Data management: The implemented risk control measure is “automated” for Peking and “Manual verification” for Wuhan. Why different? Why not implement automated in Wuhan also?

Line 193: “…but also enhanced the overall reliability of POCT….”: How do you support this claim? Data? Subjective evaluation?

Line 200-206: If manual data entry was a risk at Peking (and had to be mitigated), why was it not considered a risk at Wuhan?

Line 243-251: You sate “….highlights the efficiency of FMEA…..” and “….have significantly improved….”. Where is the data to support these claims? “Significantly” is a bold claims that requires data

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Reviewer #1: Yes:  Torello Monica

Reviewer #2: No

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Risk Management in POCT Blood Glucose Monitoring: FMEA Approach Aligned with ISO 15189:2022

PONE-D-24-51452R1

Dear Dr. Xia,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Vittorio Sambri, M.D., Ph.D.

Academic Editor

PLOS ONE