TermInfo - CCDA sample for No Immunization administered (email thread)

4 April 2013

Vinayak Kulkarni

• I am looking for an example of "No Immunization Administered". Since we have CVX code fore "No Vaccine Administered" with Code = 998, shall we use it without using negationInd="true"?

Is following sample is a valid example?

<section>
 <templateId root="2.16.840.1.113883.10.20.22.2.2.1"/>
 <code code="11369-6" codeSystem="2.16.840.1.113883.6.1" displayName="History of immunizations" codeSystemName="LOINC"/>
 <title>Immunizations</title>
 <!--**** Immunzations Section Narrative Block ****-->
 <text>
  <paragraph>
   <content ID="ZImmunizations.Immunizations.ORD-PHL02-NO-DATA">No immunizations administered or ordered.</content>
  </paragraph>
 </text>
 <entry typeCode="DRIV">
  <!--**** Immunzations Section Narrative Block ****-->
   <substanceAdministration classCode="SBADM" moodCode="INT" negationInd="false">   
   <templateId root="2.16.840.1.113883.10.20.22.4.52"/>
   <id nullFlavor="NI"/>
   <statusCode code="completed"/>
   <effectiveTime nullFlavor="NI"/>
   <consumable>
    <manufacturedProduct classCode="MANU">
     <templateId root="2.16.840.1.113883.10.20.22.4.54"/>
     <manufacturedMaterial>
       <code code="998" displayName="No Immunization administered" codeSystem="2.16.840.1.113883.12.292" codeSystemName="CVX"/>    
     </manufacturedProduct>
   </consumable>
  </substanceAdministration>
 </entry>
</section>

Lisa Nelson

• Vinayak,

Two things I notice about the sample you provided:

1. The moodCode=”INT” says, the entry is intended or planned. I don’t think that represents the right verb tense for the act. I think you need moodCode=”EVN”. (see table below for options)
2. I prefer to see examples include information in the effectiveTime element. I think you should explicitly think through the effectiveTime element and show if there should be a low or high or both, etc., just to make sure the longitudinal aspect of things doesn’t complicate the analysis.

Finally, I know these issues of semantics always open a large can of worms, but….

I think we have a vocabulary issue here. When the term is not just a clean “noun concept”, the semantics of what we are saying gets really messy and confusing. See how the concept includes the notion of the act (the verb) “baked in”, so to speak. The action concepts of “administered” and “ordered” are acts that I think our CDA architecture intends for us to represent in our act statements. Using the substance administration act already gives us the action concept of “administering a substance”. We have the moodCode attribute to control the verb tense of that action. Now, when we plug in the noun, we really need a term that is free from the other “conceptual clutter” of verbs or timeframes. So, I’m sorry to say, I think the code you are using makes for a problematic clinical statement that is necessarily ambiguous. Am I preaching to the choir, barking up the wrong tree, or being too idealistic in my expectations of what we should be aiming to accomplish with our machine readable data?

This table is from the CDA R2 standard. It shows the moodCode attribute valueSet for CDA R2. Further constraints may be included in specific templates, but this is the initial starter set of possible moodCodes for SubstanceAdministration:

Table 109: Value set for SubstanceAdministration.moodCode (CNE)
Code	Definition
EVN (event)	The entry defines an actual occurrence of an event.
INT (intent)	The entry is intended or planned.
PRMS (promise)	A commitment to perform the stated entry.
PRP (proposal)	A proposal that the stated entry be performed.
RQO (request)	A request or order to perform the stated entry.

Tom de Jong

• Dear Vinayak,

I am not an expert in the modelling of immunizations, but Pharmacy WG and PHER WG have always shared the opinion that we should treat vaccines just like ‘regular’ medicines. Having said that, and please don’t take this personally, the example below is a semantic monstrosity. One thing is clear ‘No Immunization administered‘ is not a manufactured material. You can’t administer ‘No Immunization administered‘ as a vaccine, you can’t even NOT administer it. The proper way to represent this using SBADM is by either using a SBADM.code that represents ‘immunization’ (as a general concept) or having a manufactured material code that represents all vaccines (i.e. ‘vaccine’ as a general concept). The resulting substance administration can then be negated to express that there was no occurrence of an administration of a vaccine (i.e. no immunization).

By the way, this is the same method that was used to represent ‘no known medication’ in the context of C-CDA (at least while I was involved).

I copied PHER WG, since I strongly believe domain-specific concepts should be represented consistently, regardless of the exchange mechanism.

Jean Duteau

• I agree with Tom.

Since you're not asserting that any specific vaccine/immunization did not occur, I would leave out the manufacturedMaterial altogether and just set negationInd to true and possibly use a code in the SBADM to indicate that it was an immunization. The other thing is that the mood needs to be EVN or you are just saying "we do not intend to give any immunizations".

  <!--**** Immunzations Section Narrative Block ****-->
   <substanceAdministration classCode="SBADM" moodCode="EVN" negationInd="TRUE">   
   <templateId root="2.16.840.1.113883.10.20.22.4.52"/>
   <id nullFlavor="NI"/>
   <statusCode code="completed"/>
   <effectiveTime nullFlavor="NI"/>
  </substanceAdministration>

Tom de Jong

• Lisa essentially raised the same point, but explained it in a much nicer way. I forward her response to PHER, because they should be in the loop.

By the way, totally agree that the moodCode should be EVN.

Joginder Madra

• Tom is correct. In POIZ, we would have a substance administration act in EVN mood with code = ‘IMMUNIZ’, statusCode = ‘completed’ and negationInd =’true’. You must additionally specify the date you did not administer as well as the vaccine you did not administer.

Eric Larson

• Hi all-

Just to chime a bit more on CVX code 998. In general, this alone isn't enough information. We generally need to know why and which vaccine. (I see Joginder has also chimed in as I was writing this and we are in agreement).

Code 998 in the V2 2.5.1 IG is used in the RXA segment to indicate a vaccine was not administered, but is followed by one or more OBX segments to explain why an immunization was not administered (immunity, contraindications)

"I didn't administer a vaccine because of history of chicken pox"

"I didn't administer a vaccine because of an allergy to eggs"

While both of these are client level observations the 2.5.1 guide doesn't allow for an OBX under the PID (in a VXU) and the RXA is required. Hence, 998.

The other place 998 is used is to message the forecast (or care plan) for the next date a dose should be administered. This would be similar to the SubstanceAdministrationProposal in C-CDA (I think that's correct)

C-CDA might not need code 998 at all to get the same message across. It's possible C-CDA has better places to convey these types of "non-administrations".

One final piece on non-administration in 2.5.1 (and these are truly non-administrations):

In 2.5.1, a refusal (parental, religious, etc...) of a vaccine are not a 998 situation. The CVX not administered (107^DTaP-NOS) is used in RXA-5 with code for refusal in RXA-20 and the reason for the refusal in RXA-18.

Hope this helps,

Kevin Coonan

• That is really putting a lot of meaning on a very ambiguous, and deprecated (x4 years), attribute, and I am not sure that the meaning is all that clear. It is quite possible that different implementation guides would interpret the meaning differently. You cannot infer what part(s) of the SubstanceAdministration Event is negated.

You don't know if the statement means that it immunization was given some other time (e.g. ten minutes later, i.e. not within the effectiveTime stated), or if it is currently being given (i.e. there is an active SubstanceAdministration Event).

Negating an event isn't the same as saying it didn't happen. Saying that something didn't happen is a positive assertion, and isn't at all what Act.negationInd means. By negating it, you simple say that the particular set of described values. There is an actionNegationInd attribute which should be used, if your choice of code systems doesn't properly support negative assertions.

Per the current RIM:

This attribute was deprecated for future use in HL7 Design Models at the September, 2008 Working Group Meeting, effective with RIM release 0221. The semantics of this attribute have been divided between the new actionNegationInd attribute and the Observation.valueNegationInd attribute. For existing models, designers should examine the model documentation and usage to determine which set of semantics apply. New models and new versions of existing models SHALL NOT use this attribute.

This attribute was removed from the RIM in version 2.38, per Harmonization decision in March 2012. However, subsequent analysis of the result of that step upon CMETs, Wrappers and other shared models that use this attribute led to the conclusion in July 2012 Harmonization that the action was too precipitate. The attribute was returned to the RIM in version 2.40 per Harmonization Action on July 11, 2012. It will be removed in a later version (with Harmonization approval) once a strategy to deal with this removal in existing models has been put in place.

I would encourage that PHER talk with Patient Care and Pharmacy regarding this at the next work group meeting. We need to have some harmonization and review so that immunization content can be properly represented in/between EHRS, pharmacy systems, and public health.

Vinayak Kulkarni

• Thanks to all for your inputs.

Has anybody tested "No Known Medication" scenario from NIST validator? Apperantly it is thowing error which is contradicting with the example shown in the CCDA IG below

Figure 13: No known medications example

<entry>
  <substanceAdministration moodCode="EVN" classCode="SBADM" negationInd=”true”>
    <text>No known medications</text>
    <consumable>
      <manufacturedProduct>
        <manufacturedLabeledDrug>
          <code code="410942007" displayName="drug or medication"
                codeSystem="2.16.840.1.113883.6.96"           
                codeSystemName="SNOMED CT"/>
         </manufacturedLabeledDrug>
       </manufacturedProduct>
     </consumable>
  </substanceAdministration>
</entry>

The NIST validator is expecting manufacturedMaterial/Code or manufacturedLabeledDrug/Code for respective valueset (RxNorm code in case of Medications and CVX code in case of immunizations). When you specify negationInd as "true", I would expect at least it should not fail for SNOMED code on which I am negating on.

Error :

1670|Consol Immunization Medication Information SHALL contain exactly one [1..1] manufacturedMaterial (CONF:9006) manufacturedMaterial SHALL contain exactly one [1..1] code, where the @code SHALL be selected from ValueSet Vaccines administered (CVX) 2.16.840.1.114222.4.11.934 STATIC 7 (CONF:9007)

1552|Consol Medication Information SHALL contain exactly one [1..1] manufacturedMaterial (CONF:7411) manufacturedMaterial SHALL contain exactly one [1..1] code, where the @code SHALL be selected from ValueSet Medication Clinical Drug 2.16.840.1.113883.3.88.12.80.17 DYNAMIC (CONF:7412)

Thanks