Breakpoint Survey - Document Purchasers

CLSI M100 is a critical resource for antimicrobial susceptibility testing (AST) and clinical decision‑making. This survey is intended to better understand how laboratories access and use CLSI breakpoints, how breakpoint changes are interpreted and implemented, and where challenges may arise. We appreciate your time and feedback.

Question Title

1. Let's start. What format do you use to access CLSI breakpoints?
Select all that apply. (Required.)

Print CLSI M100 document

PDF CLSI M100 document

MicroFree

CLSI M100 Plus Subscription

eCLIPSE

Question Title

2. Do you purchase a new edition when CLSI M100 is updated every year? (Required.)

Yes, immediately upon publication.

Yes, but not always at time of publication.

No, only if the stated updates seem material for our laboratory.

Other. Please elaborate.

Question Title

3. Do you use other CLSI Breakpoint guidance in your laboratory?

CLSI M24S | Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes

CLSI M27M44S | Performance Standards for Antifungal Susceptibility Testing of Yeasts

CLSI M38M51S | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi

CLSI M57S | Epidemiological Cutoff Values for Antifungal Susceptibility Testing

CLSI VET01S | Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals

CLSI VET04 | Performance Standards for Antimicrobial Susceptibility Testing of Bacteria Isolated From Aquatic Animals

CLSI VET06 | Methods for Antimicrobial Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria Isolated From Animals

None of the above

Question Title

4. Who in your organization is primarily responsible for interpreting CLSI M100 guidance? (Required.)

Laboratory leadership

Laboratory scientists

LIS/IT specialist

Infectious disease physicians

Vendor or external consultant

Microbiology/AST supervisor

Shared responsibility/Multidisciplinary team

Question Title

5. When you receive a new edition of CLSI M100, what is the first thing to happen? (Required.)

Replace all prior breakpoint values

Update only selected organism/drug pairs

Compare current SOPs against new guidance

Maintain multiple breakpoint sets simultaneously

Consult vendors or external references

Delay implementation pending validation or further assessment

Rarely or never implement updates fully

Question Title

6. Where do you experience the greatest friction in using CLSI M100 today? (Required.)

Understanding the guidance

Deciding how to act on it

Implementing changes

Validating and documenting

Defending decisions during audits

No issues implementing

Question Title

7. Do you use breakpoints from other organizations in your laboratory?

EUCAST

US FDA

No. We only use CLSI breakpoints.

Other. Please specify:

IMPLEMENTATION

Question Title

8. How do you typically determine whether breakpoint changes affect your laboratory?

Question Title

9. How are new or updated breakpoints entered into your systems? (Required.)

Applied automatically through vendor updates

Manually updated within AST instrument software

Manually entered into LIS tables

Imported or uploaded via vendor tools

Maintained partially outside systems (reference only)

Other. Please explain:

Question Title

10. How are CLSI annotations or footnotes handled? (Required.)

Encoded as system rules or logic

Addressed through manual review

Included in SOPs but not system rules

Not consistently implemented

Unsure how to encode them

Question Title

11. Which types of conditional guidance are hardest to implement technically? (Required.)

Changes that override prior values

Quality controls

Suppression or editing rules

Notes requiring clinical context

Dose- or indication-dependent guidance

Organism group restrictions

Method-specific breakpoints

Question Title

12. How do you manage multiple breakpoint versions in your environment? (Required.)

Prior or other versions retained for comparison

Version control is informal or not well tracked

Only the current CLSI version is active

Different versions used for different organisms or methods

Unsure

Question Title

13. How does your laboratory document which breakpoints are in use? (Required.)

Informal or undocumented practices

SOPs or policy documents

LIS or instrument records

Validation records

Audit-prepared documentation

BREAKPOINT INTERPRETATION

Question Title

14. Which steps are most resource-intensive? (Required.)

Documentation

SOP updates

IT/LIS configuration

Staff training

Validation/Verification

Question Title

15. How confident are you that your laboratory consistently applies CLSI breakpoints as intended? (Required.)

Moderately confident

Somewhat uncertain

Not confident

Unsure

Question Title

16. What makes annotations or footnotes most challenging to implement?

Hard to translate into LIS or instrument rules

Language is ambiguous or conditional

Difficult to find or connect to tables

Not clear when they are mandatory vs optional

Conflict with existing workflows or tools

Time constraints

Other. Please elaborate:

Question Title

17. What factors most commonly delay adoption of updated CLSI breakpoints? (Required.)

Complexity of changes

Uncertainty about regulatory expectations

Resource limitations

Risk of disrupting existing workflows

Competing institutional priorities

Question Title

18. How are breakpoint implementation errors typically discovered? (Required.)

Inspection or accreditation review

External inquiry or discrepancy

Vendor alert or update

Internal audit or review

Errors usually go undetected

Question Title

19. Which CLSI‑provided tools would most improve breakpoint implementation accuracy? (Required.)

Validation checklists or templates

Rule logic examples

Machine-readable breakpoint data

LIS/vendor mapping guidance

Version comparison and change tracking

Uncertain. No Preference.

WRAP-UP
Last few questions to help us analyze responses!

Question Title

20. What LIS platform does your organization use? (Required.)

CQM

LabWare

Epic Beaker

SCC Soft Computer

Clinisys

Do not use LIS

Other. Please specify.

Question Title

21. What AI tools does your organization currently use or allow?

Microsoft Copilot

ChatGPT

Gemini

Claude

Perplexity

Other. Please specify:

Question Title

22. How would you characterize your overall sentiment toward AI right now? (Required.)

Negative/overwhelmed

Positive/excited

Clear

i We adjusted the number you entered based on the slider’s scale.

Question Title

23. What is your role? (Required.)

Executive

Laboratory Operations

Quality Management

Manufacturing/Production

Regulatory Affairs/Compliance

Other. Please specify:

Question Title

24. Which best describes your organization? (Required.)

Public health institution

Large academic or health system laboratory

Single site hospital or clinic

Independent or reference laboratory

Government agency

IVD manufacturer

Consultancy

Other

Question Title

25. Where is your work located?

Canada

Mexico

South or Central America

Europe

Asia

Africa

Australia

Breakpoint Survey - Document Purchasers

Question Title

* 1. Let's start. What format do you use to access CLSI breakpoints?Select all that apply. (Required.)

Question Title

* 2. Do you purchase a new edition when CLSI M100 is updated every year? (Required.)

Question Title

* 3. Do you use other CLSI Breakpoint guidance in your laboratory?

Question Title

* 4. Who in your organization is primarily responsible for interpreting CLSI M100 guidance? (Required.)

Question Title

* 5. When you receive a new edition of CLSI M100, what is the first thing to happen? (Required.)

Question Title

* 6. Where do you experience the greatest friction in using CLSI M100 today? (Required.)

Question Title

* 7. Do you use breakpoints from other organizations in your laboratory?

Question Title

* 8. How do you typically determine whether breakpoint changes affect your laboratory?

Question Title

* 9. How are new or updated breakpoints entered into your systems? (Required.)

Question Title

* 10. How are CLSI annotations or footnotes handled? (Required.)

Question Title

* 11. Which types of conditional guidance are hardest to implement technically? (Required.)

Question Title

* 12. How do you manage multiple breakpoint versions in your environment? (Required.)

Question Title

* 13. How does your laboratory document which breakpoints are in use? (Required.)

Question Title

* 14. Which steps are most resource-intensive? (Required.)

Question Title

* 15. How confident are you that your laboratory consistently applies CLSI breakpoints as intended? (Required.)

Question Title

* 16. What makes annotations or footnotes most challenging to implement?

Question Title

* 17. What factors most commonly delay adoption of updated CLSI breakpoints? (Required.)

Question Title

* 18. How are breakpoint implementation errors typically discovered? (Required.)

Question Title

* 19. Which CLSI‑provided tools would most improve breakpoint implementation accuracy? (Required.)

Question Title

* 20. What LIS platform does your organization use? (Required.)

Question Title

* 21. What AI tools does your organization currently use or allow?

Question Title

* 22. How would you characterize your overall sentiment toward AI right now? (Required.)

Question Title

* 23. What is your role? (Required.)

Question Title

* 24. Which best describes your organization? (Required.)

Question Title

* 25. Where is your work located?

1. Let's start. What format do you use to access CLSI breakpoints?
Select all that apply. (Required.)

2. Do you purchase a new edition when CLSI M100 is updated every year? (Required.)

3. Do you use other CLSI Breakpoint guidance in your laboratory?

4. Who in your organization is primarily responsible for interpreting CLSI M100 guidance? (Required.)

5. When you receive a new edition of CLSI M100, what is the first thing to happen? (Required.)

6. Where do you experience the greatest friction in using CLSI M100 today? (Required.)

7. Do you use breakpoints from other organizations in your laboratory?

8. How do you typically determine whether breakpoint changes affect your laboratory?

9. How are new or updated breakpoints entered into your systems? (Required.)

10. How are CLSI annotations or footnotes handled? (Required.)

11. Which types of conditional guidance are hardest to implement technically? (Required.)

12. How do you manage multiple breakpoint versions in your environment? (Required.)

13. How does your laboratory document which breakpoints are in use? (Required.)

14. Which steps are most resource-intensive? (Required.)

15. How confident are you that your laboratory consistently applies CLSI breakpoints as intended? (Required.)

16. What makes annotations or footnotes most challenging to implement?

17. What factors most commonly delay adoption of updated CLSI breakpoints? (Required.)

18. How are breakpoint implementation errors typically discovered? (Required.)

19. Which CLSI‑provided tools would most improve breakpoint implementation accuracy? (Required.)

20. What LIS platform does your organization use? (Required.)

21. What AI tools does your organization currently use or allow?

22. How would you characterize your overall sentiment toward AI right now? (Required.)

23. What is your role? (Required.)

24. Which best describes your organization? (Required.)

25. Where is your work located?