Factors.
II 1. this requires a degree of sophistication on behalf of a reporter in order to appropriately understand the factors and ascribe them to the event. Again, if these are going to be recommended as part of a reporting and learning system, this will result in highly complex and time consuming reporting what do the small numbers and letters refer to?
Comment: We agree that a granular comprehensive classification system is being constructed, but this is necessary if it is going to be useful. Alpha numeric codes should be a part of the software and should not be visible.
II 2. ?
II 3. Please consider something like "genesis or increased severity". "Mitigating factors" are covered independently, but there may be contributory aspects that worse a case, too.
Comment: The definition has been revised to address this.
II 4. Suggest replacing with the word with "development" to read - A circumstance, action or influence which plays a part in the development of a patient safety event
Comment: The definition has been revised.
II 5. no answer
II 6. maybe include lack of action, omission; often the policies are there but there is a huge people's component (healthcare staff)influencing the implementation of these policies.
Comment: The concept for failure to comply with policies is included as a concept under this class.
II 7. As noted above, need to delete the word 'influence' and add words to indicate that the contributing factors are those 'thought' to have contributed - i.e. acknowledging the uncertainty in processes such as RCA.
Comment: The definition has been revised.
II 8. a more commonly used word than genesis Comment: The definition has been revised.
II 9. Consider: Rather than At-Risk Behaviour- Utilize the phrase "departure from a standard practice".
Comment: The terminology for this concept is being reconsidered based upon this and other comments.
II 10. I suggest to include contributing factors associated with patient, healthcare organization, health personnel.
Comment: The contributing factor class includes these concepts.
II 11. A circumstance, action or influence which leads to/initiates . Comment: The definition has been revised to reflect this.
II 12.
II 13. A circumstance, action or influence which was identified to have directly contributed to the patient safety event.
Comment: The definition has been revised.
II 14. See above
Page 69 of 194 II 15. either call the cause the cause or re-define contributing factors; if a factor contributed to an event, did
it cause it?
Comment: The revised definition clarifies what we mean by “contributing factor”
II 16. Genesis should be replaced with development or unfolding of a patient safety event Comment: The definition has been revised.
II 17. use beginning, start or other synonym Comment: The definition has been revised.
II 18. The circumstances, actions, influences which MAY lead to this /these patient safety events Comment: The definition has been revised to reflect this.
II 19. A circumstance, action or influence which plays a part in the genesis and/or development of a patient safety event
Comment: The definition has been revised.
II 20. Contributing Factor - A circumstance, action...
Comment: The definition has been revised.
II 21. It's important to look at societal characteristics, and not simply the immediate geographic area around a patient safety event, to determine what really is contributing to iatrogenic harm.
Comment: We anticipate that the classification will handle this.
II 22. don't have one - just the caution II 23. as above
II 24. Alter genesis to another word (? causation) Comment: The definition has been revised.
II 25. see question
II 26. Any situation or influence which plays a part in the initiation, development or outcome of a patient safety event.
Comment: We believe that the revised definition deals with this suggestion.
II 27. x
II 28. I would suggest possibly a sub classification here that would guide thinking.
Comment: We believe the classification will accomplish this.
II 29. Contributing Factors
II 30. would it help to add 'practical' circumstance?
II 31. Are there areas where one must look for contributing factors?
Comment: This is an issue to be addressed in the business rules, rather than the classification itself.
II 32. Issues seems to me to reflect the nuance better than factors - Contributing Issues. Perhaps this is just stylistic
Comment: Contributing factors is a commonly used phrase.
II 33. See my previous comments
Page 70 of 194 II 34. A circumstance, action or influence which plays a part in the genesis of a patient safety event or has an
impact of its course.
Comment: The definition has been revised.
II 35. see my previous comment II 36. Contributing factors such as II 37. None
II 38. Need a structured approach to RCA with standardized methodology
Comment: Agree, but believe this is outside the realm of the classification and is rather to do with the business rules describing how information is collected.
II 39. ?use contributing
Comments from the Question – Do you believe this is a meaningful and useful class?
III
III 1. unclear to distinguish from event modifiers Comment: The revised definition clarifies this.
III 2. already gave this reason - a term already exists it could be co-morbidity or Clinical feature
III 3. As noted above, I am not sure what type of information you are after here. However, in general terms, the identification and assignment of 'contributing factors' is an inexact science and there are multiple variations on what is considered to be a useful categorisation with sufficient detail to be of use, but still able to replace full text information. The proposed classification in the main document is not mutually exclusive and would be very difficult to use. The inclusion of 'patient factors' should be reconsidered. As listed, they are 'pre-existing conditions' and could be better regarded as 'patient characteristics'.
(Wherever they are located, they should be described using both ICD and ICF.) This issue of patient factors really brings to the fore the notion of what are considered to be 'risk factors' for the
events/outcomes. To some extent, it does not matter whether they are called 'contributing factors' or 'patient characteristics' provided that they are recorded somewhere in the framework (but only once) and the data are available for analysis.
Comment: We agree that patient factors should be able to be included as contributing factors to a particular incident. The classification discriminates between pre-existing co-morbidities and conditions and patient factors which have a direct bearing on the incident in question.
III 4. There can be confusion about what is a "contributing factor" or an "event characteristic".
Comment: The revised definition clarifies this.
III 5. This section of the taxonomy would benefit from further development. If the aim is to point the way to changes in the healthcare system that might reduce the number of patient safety incidents, it follows that ICPS must identify "system" causes as well as idiosyncratic causes. At present, this section is populated mainly by patient factors and human or performance factors on the part of the clinician and the balance should be redressed in favour of "system" causes. I have recently analysed a typical cross section of 230 claims and shortcomings in clinical governance processes were implicated in more than half of the serious patient safety incidents that give rise to them. However, most of the relevant processes are not
mentioned at all in ICPS, despite the fact that many of them could be remedied in quite obvious ways, albeit at some expense. This may be done by including some of the clinical governance processes which are apt to cause patient safety incidents when they fail. There are about two dozen of them and they relate to such matters as making adequate arrangements for known higher risk patients, someone taking overall responsibility for the patient, the credentialing and induction of new staff. So far as the Human Factors are concerned, I am not sure that the distinction between knowledge based, rule based and skill based factors will be easily learned or applied to an initial classification of the data. The other human and performance factors identified are either too broad (e.g. communication, documentation) to point the way to feasible reforms of the healthcare system, in which case they need to be broken down into more
Page 71 of 194 specific processes, or too cryptic, in which case they should be clarified or abandoned. V.B Work
environment factors are all right. V.C. Patient factors - of the several thousand healthcare providers who use our classification system, not one has ever asked for patient factors to be classified in this way for the purpose of incident reporting and I query whether this is a useful initial category. Perhaps it could be deferred to some subsequent release. V.D. Organizational factors - These need to be defined with greater precision and this section of the taxonomy should be enlarged to encompass the organizational processes which are apt to cause patient safety incidents when they fail. The same is true of V.E. - External factors.
Comment: We agree that the system and organizational issues need to be accommodated in this section of the classification. We hope we will have categories relevant to the issues that you raise about overall responsibility, credentialing and induction of new staff. We agree that it is unlikely that most reports will be able to discriminate between the various types of errors and that an overall problem with a
classification like this is achieving some balance between ease of use and granularity. Although you question the validity of having patient factors here, we believe it is important and this has been emphasized by other respondents to the Delphi process. We agree that organizational and external factors need to be able to be classified in some detail.
III 6. Same as earlier
III 7. If the plan is to include considerations around teamwork, conflict styles, profit or not-for-profit status of a healthcare system, this will be more than adequate. Contributory factors are far more insidious than 'inadequate documentation'. The question why a person chose to document in a certain way that may or may not have contributed to the event should be understood: there can be a perfectly 'good' reason why 'adequate documentation' was not completed-maybe none of the staff in question document in the 'adequate' manner. And who is defining 'adequacy'? The patient? The nurse? The risk-manager? The malpractice lawyer for patients?
Comment: We agree with your comments and reservations and agree that documentation should be able to be described with considerable granularity. Who decides what should be a contributing factor and what constitutes “adequate” is a major philosophical question for who should be acquiring information and who should be classifying it.
III 8. Unclear relationship with contributing factors and patient characteristics Comment: We believe the revised definition has clarified this.
III 9. This class is crucial. My worry is that everybody will expend their energies on fine distinctions to do with patient and event characteristics, and forget that the crucial outcome out of all this is how to prevent recurrence.
Comment: We agree with your point and although it is often the case too much time is spent on gathering information rather than on fixing problems, data collection, and analysation are essential for learning.
III 10. It is too broad a category.
Comment: Since this is a “high level” or “parent class” it is intended to be broad and stable.
III 11. As event characteristics
III 12. perceptions of contributing factors will vary from individual to individual and from organization to organization
Comment: We agree, and this is central to the balance between validity and liability.
III 13. See my previous comments III 14. see my comments
III 15. Without standardized approaches and methodology this is of little use. The entire concept for this effort seems to be more of a research type endeavor with little real world use.
Comment: We agree but to have a useful body of information, there should be standardized approaches to eliciting information from the real world and putting it into a form where it can be stored, aggregated, compared, and analysed. The issue is the balance between validity and reliability in deconstructing real world incidents into what we hope are useful components or concepts.
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