1. C-CDA: Problem/Allergy Problem Status Observation Templates and Clinical Status Post Madrid WGM update
Stephen Chu, PCWG co-chair
Emma Jones, PCWG co-chair
Rob Hausam, PCWG vocab facilitator
Lisa Nelson, PCWG Liaison from SDWG

2. Background CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19
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3. Background CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19
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4. Background
CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19, 20
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5. Background
CDA r2.0 IG C-CDA CLINNOTES R2.1Vol1 November 2014, p.19, 20
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6. Background
CDA r2.0 IG C-CDA CLINNOTES R2.1deprecated two clinical status related templates:
Allergy status observation (Vol1, p.49)
Problem status (Vol1, p.53)
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7. What are the problems?
Given that it has been argued that the statusCode “reflects the state of the activity”, i.e. the observation itself, and “not the status of what is being observed”, e.g. the clinical status itself
It is unclear how it can then argue that the statusCode of the Problem Concern Act is the “definitive indication of the status of the concern” i.e the “what is being observed”?
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8. What are the problems?
inadequate for
expressing the
rich semantics
clinical status
of the problem
or concern
statusCode:
Metadata
(document
property)
Not displayed
as human
readable data.
How is that
useful for
expressing
clinical status?
Using “statusCode + effectiveTime to communicate “status”: inadequate

9. What are the problems?
In the absence of these templates, “problem concern status” is represented by “statusCode” + effectiveTime:
The statusCode of the Problem Concern Observation is the definitive indication of the status of the concern
Issues
Status of the concern = status of the Act (workflow status)
“isDocumentProperty” of statusCode is supposed to = true (hence it is a document property, not a clinical property)
≠ rich semantics of clinical status of the problem/concern
research on the RIM indicates that the statusCode does not carry meaning that would be present in the human readable narrative
The effectiveTime of the Problem Observation is the definitive indication of whether or not the underlying condition is resolved
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10. What are the problems?
statusCode values represent workflow / object states
Extract from a “Life Cycle and Object State Transition” document published on 4 April 2011:
Under the rules set out in the HL7 RIM, classes have statusCodes, which means that an object (i.e. an instance of a class) may have a defined state
At any time an object with a defined state machine has a specified state drawn from a fixed repertoire of states defined for its class. The state of the object is changed by events that act on the object; each event is drawn from a fixed repertoire of events defined for its class and has an associated rule specifying the new state of the object given the state of the object at the time of the event
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11. What are the problems? These workflow/object state
transition values are inadequate
and inappropriate for
representing the complex
clinical status
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12. Deprecation: result of a technical misunderstanding?
The deprecation of the two templates may be considered a technical confusion of the ACT of observation (ACT.statusCode) and what is being observed (the clinical status values)
The use of statusCode + effectiveTime is clearly inappropriate and inadequate for representing clinical status
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13. Un-deprecate the Allergy/Intolerance and Problem Status templates
Previous discussions between PCWG and SDWG have reached agreement that:
The semantic complexity requires the reinstatement of:
Problem status template
Allergy status observation template
If it can be agreed that the deprecation was a result of technical confusion
Can these two templates be un-deprecated through an errata process?
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14. Clinical status value sets: the current state
The status of most clinical problems or conditions need to be represented by a set of clinical status specific values:
Active
Controlled
Well controlled
Poorly controlled
Stabilized
Refractory
(??? Use pre-coordination, e.g. refractory schizophrenia)
Relapse
Recurrence
Inactive
Remission
Resolved
FHIR Condition.clinicalStatus
code values
FHIR Change Requests #13025
PCWG FHIR Conference call:
Added “relapse” as a child of “active”
FHIR Change Requests #13026
PCWG-FHIR call:
Added “controlled” and “poorly controlled”
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15. Clinical status value sets: the current state
The clinical status of Allergy/Intolerance need to be represented by a set of clinical status specific values:
Active
Inactive
Resolved
Why the value sets for Condition and Allergy/Intolerance are different?
Condition is a present or past state. 
Allergy/intolerance is a propensity to future reaction
They (condition and allergy/intolerance) do not have the same or even analogous clinical status value sets
FHIR Allergy/Intolerance.clinicalStatus
code values
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16. Clinical status value set
Definitions:
Active – The subject is currently experiencing the symptoms of the condition or there is evidence of the condition
Well controlled – The subject's condition is adequately or well managed such that the recommended evidence-based clinical outcome targets are met
Poorly controlled – The subject's condition is inadequately/poorly managed such that the recommended evidence-based clinical outcome targets are not met
Recurrence – the subject is experiencing a re-occurrence or repeating of a previously resolved condition
Example: recurrence of (previously resolved) urinary tract infection, pancreatitis, cholangitis, conjunctivitis
Relapse – the subject is experiencing a return of a condition, or signs and symptoms after a period of improvement or remission
Examples: relapse of cancer, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, bipolar disorder, [psychotic relapse of] schizophrenia, etc
Inactive – The subject is no longer experiencing the symptoms of the condition or there is no longer evidence of the condition
Remission – The subject is no longer experiencing the symptoms of the condition, but there is a risk of the symptoms or condition returning
Resolved – The subject is no longer experiencing the symptoms of the condition and there is a negligible perceived risk of the symptoms returning
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17. Suggested action (1) Reinstate the deprecated C-CDA templates:
The “Allergy Status Observation” template should be renamed to “Allergy/Intolerance Clinical Status Observation”
The “Problem Status” template should be renamed to “Problem Clinical Status Observation” to be consistent
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18. Suggested action (2)
Observation.code values needed for Allergy/Intolerance Observation template
Both Allergy
Status
Observation
and
Problem Status
templates
use same
LOINC code:
3399-4
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19. Suggested action (2)
Observation.code values needed for these two templates
Both Allergy
Status
Observation
and
Problem Status
Templates
use same
LOINC code:
3399-4
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20. Suggested action (3)
Use FHIR clinical status value sets for Allergy/Intolerance and Problem Clinical Status observation.value slot
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21. Suggested action (3)
Problem clinical status values
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22. Suggested action (3) Allergy/Intolerance clinical status values
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23. Further discussions
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24. Allergy Problem Observation in C-CDA 1.1
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25. Allergy Status Observation in C-CDA 1.1
Table 126: Allergy
Status Observation
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26. Problem Observation in C-CDA 1.1
The “Problem Status” Observation uses the same HITSPProblemStatus
values
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27. In C-CDA 2.0 Allergy Status Observation and Problem Status templates are deprecated
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28. In C-CDA 2.0 Allergy Status Observation and Problem Status templates are deprecated
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