No Information Allergy Section

[Brian Weiss]

The detour related to handling Coded Concepts is still being travelled, but I wanted to return now to the original first sample-creation effort, which was a “Baseline C-CDA CCD” containing “no information”.  While there is no clinical use case I am aware for creating an entire C-CDA CCD that says nothing, this exercise is believed useful for two reasons:

 

·         The need to report individual section templates with “no information” is very prevalent.  A sample scenario would be an EMR generating a CCD off of a patient record with only partial information.

 

·         For testing purposes, it’s helpful to have a generic “baseline” CDA document that validates OK and into which test snippets can be “dropped in”.

 

Attached is one page containing one section (the Allergy Section) of the “Baseline No Information C-CDA CCD”.  It validates on TTT with no errors and no warnings.

 

Happy if anyone wants to actually through it, but not expecting anyone to do that.  Instead, I will call out the key questionable areas (called out with embedded comments in the document) that I think warrant feedback here:

 

1)      Use of nullFlavor="NI" on an observation or act element.  The C-CDA IG does this for observation in Figure 213 on page 450.  It does it for substanceAdministration in Figure 12 on page 40.  So, need some guidance on when that is and isn’t appropriate.

 

2)      What to use in a “no information” effectiveTime range.  There is an effectiveTime element in the Allergy Problem Act (the concern), the Allergy – Intolerance Observation, and the Reaction Observation.  Seems pretty clear that the low sub-element of effectiveTime should get a nullFlavor="NI".  My intuition was to do the same for the high sub-element (in general, I prefer to put NI anywhere possible, to just indicate “have nothing to say here – just filling out this element because I am forced to for conformance” – sort of like marking “NA” all over a form that I know nothing about from a content perspective… but Lisa made a good case for putting in the date of the CCD creation for high, as it is better to cap the date for the concern and the allergy observation, as otherwise there might be an incorrect inference about some concern or observation being “ongoing”.  Challenging to deal with “semantics of no information”… I’d welcome any guidance.

 

3)      With minimal narrative text to work with (“No Information About Allergies”) it was challenging to fill in all the SHAL/SHOULD text and originalText elements.  Basically kept pointing to that same line.

 

4)      As per my earlier mail, there are two places (one in the Severity Observation template – which itself appears twice, once in reference to the Allergy Observation and once in reference to the Reaction Observation – and one in the Reaction Observation) where the value element is used for a coded concept and the language of the conformance statements (7335 and 7356) seems to want to disallow nullFlavor by placing a SHALL on the @code attribute.  As per my earlier mail, I nonetheless used nullFlavor="NI" with the (questionable) rationale that the “…where the @code SHALL…” language  provides some wiggle room relative to “…SHALL have exactly one @code which SHALL…” language.  Validator is happy with it and the alternative (picking something from the Value Set when we have “no information”) doesn’t seem good.

 

I think those four were the main challenges.  Could be I needed to call out something else questionable here that I wasn’t sensitive enough to realize/understand was problematic…

 

Brian

 

[Kate Hamilton]

To your 4 points --

4. If @nullFlavor passes validation when the IG constraints disallow it, that sounds like a validator bug.

3. If you get error messages for required children of an optional & absent element, that sounds like a validator bug.

2. For when @negationInd is available, see the base standard, i.e. the CDA specification, or the CDA Schema, cda.xsd.


1. It's great that CDA implementation is surfacing the conflation of "Unknown" with "None known" in patient records.
This alone will go far to improve quality of healthcare data and to reduce costs and risks.

A Continuity of Care Document requires providing information about patient allergies.
"No information about allergies" in a continuity-of-care document is an information gap, whatever the medium.
The CCD specification captures that.


How does an implementer go forward in this situation? Others may have better ideas but I would think of --

It might be appropriate for a records manager to seek excusal from the rule. For example, one might request that evaluation of validation results overlook this error if the data was recorded earlier than (some date).

The value of this approach is that it does not require an IG change to legitimize recording "No information"! Simply omitting the entry represents the truth quite correctly -- no conformant entry could be provided -- and will generate the error message one hopes to have excused.

An important action for the C-CDA implementer would be to discuss with the records manager the need, going forward, to distinguish between "Unknown" and "None known".

K

From: "Brian Weiss"

Date: 06/21/13 12:24

Subject: No Information Allergy Section

The detour related to handling Coded Concepts is still being travelled, but I wanted to return now to the original first sample-creation effort, which was a “Baseline C-CDA CCD” containing “no information”.  While there is no clinical use case I am aware for creating an entire C-CDA CCD that says nothing, this exercise is believed useful for two reasons:

 

·         The need to report individual section templates with “no information” is very prevalent.  A sample scenario would be an EMR generating a CCD off of a patient record with only partial information.

 

·         For testing purposes, it’s helpful to have a generic “baseline” CDA document that validates OK and into which test snippets can be “dropped in”.

 

Attached is one page containing one section (the Allergy Section) of the “Baseline No Information C-CDA CCD”.  It validates on TTT with no errors and no warnings.

 

Happy if anyone wants to actually through it, but not expecting anyone to do that..  Instead, I will call out the key questionable areas (called out with embedded comments in the document) that I think warrant feedback here:

 

1)      Use of nullFlavor="NI" on an observation or act element.  The C-CDA IG does this for observation in Figure 213 on page 450.  It does it for substanceAdministration in Figure 12 on page 40.  So, need some guidance on when that is and isn’t appropriate.

 

2)      What to use in a “no information” effectiveTime range.  There is an effectiveTime element in the Allergy Problem Act (the concern), the Allergy – Intolerance Observation, and the Reaction Observation.  Seems pretty clear that the low sub-element of effectiveTime should get a nullFlavor="NI".  My intuition was to do the same for the high sub-element (in general, I prefer to put NI anywhere possible, to just indicate “have nothing to say here – just filling out this element because I am forced to for conformance” – sort of like marking “NA” all over a form that I know nothing about from a content perspective… but Lisa made a good case for putting in the date of the CCD creation for high, as it is better to cap the date for the concern and the allergy observation, as otherwise there might be an incorrect inference about some concern or observation being “ongoing”.  Challenging to deal with “semantics of no information”… I’d welcome any guidance.

 

3)      With minimal narrative text to work with (“No Information About Allergies”) it was challenging to fill in all the SHAL/SHOULD text and originalText elements.  Basically kept pointing to that same line.

 

4)      As per my earlier mail, there are two places (one in the Severity Observation template – which itself appears twice, once in reference to the Allergy Observation and once in reference to the Reaction Observation – and one in the Reaction Observation) where the value element is used for a coded concept and the language of the conformance statements (7335 and 7356) seems to want to disallow nullFlavor by placing a SHALL on the @code attribute.  As per my earlier mail, I nonetheless used nullFlavor="NI" with the (questionable) rationale that the “…where the @code SHALL…” language  provides some wiggle room relative to “…SHALL have exactly one @code which SHALL…” language.  Validator is happy with it and the alternative (picking something from the Value Set when we have “no information”) doesn’t seem good.

 

I think those four were the main challenges.  Could be I needed to call out something else questionable here that I wasn’t sensitive enough to realize/understand was problematic…

 

Brian

 

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[Brian Weiss]

Even though it results in warning messages, I decided it was better to leave off the sub-elements of the Allergies section that are marked SHOULD (the Reaction Observation template, the Severity Observation template, and the participant element).

In general, SHOULD elements "should" be included (one HL7 leader has said something to the effect that a "SHOULD" is often a "SHALL" that was debated and as a compromise became a "SHOULD" - but ideally would have been a "SHALL").  And we all prefer "clean" validator results with no warning messages...

However, there are times where we have to take advantage of the "SHOULD" not being a "SHALL".  I think the "No Information" case is one of those times.  Adding more data fields about which we have no information (and then struggling to figure out the best way to say "i have no idea" in a C-CDA compliant way) doesn't really make sense.  So, we'll accept the warning messages, and keep the sample smaller...

Attached is the latest version (of just the Allergy section).  I think we are almost there, pending some possible comments about how to handle the effectiveTime elements (there are now only two of them).  Now I will go back and refresh the whole "baseline sample" using the same principles here (leaving off the "SHOULD" elements, etc.).

However, I will also create a version that includes all the SHOULD elements in a way that passes the validator with no warnings.  This is helpful purely for testing purposes as a "clean-validating baseline" that we can use to test other samples - even though I don't think it is the right way to actually say "no information" (the right way to do that, as noted above, is to leave off the SHOULD sub-elements and accept the warning messages).

Brian

[Boone, Keith W (GE Healthcare)]

I completely agree that "SHOULD" shall be ignored in these cases.  ;-)

You have a good reason not too, which is exactly the kind of exception that SHOULD is designed to allow for.

 

            Keith

 

 

From: owner-s...@lists.hl7.org [mailto:owner-s...@lists.hl7.org] On Behalf Of Brian Weiss
Sent: Monday, July 01, 2013 6:41 AM
To: ccda_s...@googlegroups.com
Cc: Structured Documents WG
Subject: Re: No Information Allergy Section

 

Even though it results in warning messages, I decided it was better to leave off the sub-elements of the Allergies section that are marked SHOULD (the Reaction Observation template, the Severity Observation template, and the participant element).

 

In general, SHOULD elements "should" be included (one HL7 leader has said something to the effect that a "SHOULD" is often a "SHALL" that was debated and as a compromise became a "SHOULD" - but ideally would have been a "SHALL").  And we all prefer "clean" validator results with no warning messages...

 

However, there are times where we have to take advantage of the "SHOULD" not being a "SHALL".  I think the "No Information" case is one of those times.  Adding more data fields about which we have no information (and then struggling to figure out the best way to say "i have no idea" in a C-CDA compliant way) doesn't really make sense.  So, we'll accept the warning messages, and keep the sample smaller...

 

Attached is the latest version (of just the Allergy section).  I think we are almost there, pending some possible comments about how to handle the effectiveTime elements (there are now only two of them).  Now I will go back and refresh the whole "baseline sample" using the same principles here (leaving off the "SHOULD" elements, etc.).

 

However, I will also create a version that includes all the SHOULD elements in a way that passes the validator with no warnings.  This is helpful purely for testing purposes as a "clean-validating baseline" that we can use to test other samples - even though I don't think it is the right way to actually say "no information" (the right way to do that, as noted above, is to leave off the SHOULD sub-elements and accept the warning messages).

 

Brian

On Friday, June 21, 2013 1:49:37 PM UTC+3, Brian Weiss wrote:

***********************************************************************************

[Benjamin Flessner]

Is Allergy Severity a SHALL 1..1 (per CONF 16341 in Dec. Errata package) or a SHOULD 0..1 (per CONF 9961)?

 

(This is errata comment 296 which was resolved as ‘will fix’ on the 7/11 call, but it doesn’t state which direction it will be fixed in).

[Kumara Prathipati]

Can some one point me to the  full vocabulary value set for EVIL_TS data  type in medication entry?

I need to use medication administration timings like

1 hr before meal
with meal
1 hr after meal
at bed time
etc..

I was able to locate FHIR value set (http://hl7.org/implement/standards/fhir/v3/TimingEvent/) for this purpose but not sure if it is official to use in CCDA for MU2?

Once again, it is useful if CCDA IG provides url to find required value sets used in each section/entry

Kumara

---

From: Benjamin Flessner <Benj...@epic.com>
To: "Boone, Keith W (GE Healthcare)" <keith...@ge.com>; Brian Weiss <brian...@cdapro.com>; "ccda_s...@googlegroups.com" <ccda_s...@googlegroups.com>
Cc: Structured Documents WG <stru...@lists.hl7.org>
Sent: Thursday, July 11, 2013 8:37 AM
Subject: {C-CDA Samples} RE: No Information Allergy Section

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[Brian Weiss]

Kumara,

 

Like all “CDA data types”, EIVL_TS (“EVIL” would be a negative judgment call J) is spelled out technically in the CDA Normative Edition in section 5.2 of Data Types – Abstract Specification (file-name: …/infrastructure/datatypes/datatypes.htm).

 

I believe the coded concepts you are looking for are in the chart below (Table 45 Domain TimingEvent) from that section:

 

Keith’s CDA book shows an example of how an EIVL type of effectiveTime is formulated from an XML syntax perspective:

Brian

[Tom de Jong]

Hello Kumara,

 

Copying Pharmacy WG, because there should be consensus across the Pharmacy domain about this value set.

 

You will find the HL7 code system TimingEvent (OID 2.16.840.1.113883.5.139), as part of the most recent HL7v3 ballot package, here:

 

http://www.hl7.org/v3ballotarchive_temp_3513DB90-1C23-BA17-0CFBAE42B90C04E5/v3ballot/html/infrastructure/vocabulary/TimingEvent.html

 

This contains the following codes:

 

TimingEvent      [2.16.840.1.113883.5.139]
Lvl- Typ	Concept Code   Head Code-defined Value Set	Print Name	Definition, Properties, Relationships
0-L	AC	AC	before meal (from lat. ante cibus)
0-L	ACD	ACD	before lunch (from lat. ante cibus diurnus)
0-L	ACM	ACM	before breakfast (from lat. ante cibus matutinus)
0-L	ACV	ACV	before dinner (from lat. ante cibus vespertinus)
0-S	C	C	meal (from lat. ante cibus)
1-L	. CD	CD	lunch (from lat. cibus diurnus)
1-L	. CM	CM	breakfast (from lat. cibus matutinus)
1-L	. CV	CV	dinner (from lat. cibus vespertinus)
0-L	HS	HS	Prior to beginning a regular period of extended sleep (this would exclude naps). Note that this might occur at different times of day depending on a person's regular sleep schedule.
0-L	IC	IC	between meals (from lat. inter cibus)
0-L	ICD	ICD	between lunch and dinner
0-L	ICM	ICM	between breakfast and lunch
0-L	ICV	ICV	between dinner and the hour of sleep
0-L	PC	PC	after meal (from lat. post cibus)
0-L	PCD	PCD	after lunch (from lat. post cibus diurnus)
0-L	PCM	PCM	after breakfast (from lat. post cibus matutinus)
0-L	PCV	PCV	after dinner (from lat. post cibus vespertinus)
0-L	WAKE	WAKE	Upon waking up from a regular period of sleep, in order to start regular activities (this would exclude waking up from a nap or temporarily waking up during a period of sleep)

 

I’ve done some clean-up in the descriptions to condense the size of the table. It is a known fact that this code system is far from perfect, since it mixes actual events of daily living with intervals relative to those events (e.g. ‘lunch’ and ‘between lunch and dinner’) This has been fixed in data types R2, but that’s out of scope for CDA R2 implementations. It would be good to agree about which value set to apply (full code system or a subset), to identify use cases that are not covered by the code system, and to specify implementation guidelines for how to use the codes (possibly combined with a quantified offset, e.g. ‘30 minutes before lunch’).  

These guidelines are needed in a wider context than just MU2, since it’s known that many ongoing and planned implementations struggle with this

 

Hope this helps to start off the creation of these implementations guidelines,

Best,

Tom.

 

Van: owner-s...@lists.hl7.org [mailto:owner-s...@lists.hl7.org] Namens Kumara Prathipati
Verzonden: vrijdag 12 juli 2013 9:15
Aan: Benjamin Flessner; Boone, Keith W (GE Healthcare); Brian Weiss; ccda_s...@googlegroups.com
CC: Structured Documents WG
Onderwerp: MEDICATION SECTION EVIL_TS VOCABUALRY set url

 

Can some one point me to the  full vocabulary value set for EVIL_TS data  type in medication entry?

I need to use medication administration timings like

1 hr before meal
with meal
1 hr after meal
at bed time
etc..

I was able to locate FHIR value set (http://hl7.org/implement/standards/fhir/v3/TimingEvent/) for this purpose but not sure if it is official to use in CCDA for MU2?

Once again, it is useful if CCDA IG provides url to find required value sets used in each section/entry

Kumara

 

 

---

From: Benjamin Flessner <Benj...@epic.com>

To: "Boone, Keith W (GE Healthcare)" <keith...@ge.com>; Brian Weiss <brian...@cdapro.com>; "ccda_s...@googlegroups.com" <ccda_s...@googlegroups.com>
Cc: Structured Documents WG <stru...@lists.hl7.org>
Sent: Thursday, July 11, 2013 8:37 AM

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[Kumara Prathipati]

Tom,

Thanks for the help with EIVL_TS data type vocabulary value set.
Are these 2 below examples accurate or did I make any mistakes?

Kumara


//lunch time//
<effectiveTime xsi:type="EIVL_TS" operator="A">
<event code="CD"/>
</effectiveTime>


//1 HR BEFORE LUNCH//
<effectiveTime xsi:type="EIVL_TS" operator="A">
<event code="CD"/>
<offset>
    <low value='-1' unit='h'/>
</offset>
</effectiveTime>

---

From: Tom de Jong <t...@nova-pro.nl>
To: 'Kumara Prathipati' <kuma...@yahoo.com>; 'Benjamin Flessner' <Benj...@epic.com>; "'Boone, Keith W (GE Healthcare)'" <keith...@ge.com>; 'Brian Weiss' <brian...@cdapro.com>; ccda_s...@googlegroups.com
Cc: 'Structured Documents WG' <stru...@lists.hl7.org>; phar...@lists.hl7.org
Sent: Friday, July 12, 2013 2:41 AM
Subject: RE: MEDICATION SECTION EVIL_TS VOCABUALRY set url

[Kumara Prathipati]

Tom,

I have another example of frequency where i am lost...

"Viagra 50 mg tablet by mouth , 15 minutes before sex , 1 to 2 times a week."
How do I represent this in<effectivetime> EIVL_TS data type?

The official recommendation is as follows...
For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA (sildenafil citrate) may be taken anywhere from 4 hours to 0.5 hour before sexual activity.

Kumara

[Kumara Prathipati]

Sometimes we say

XYZ tablet 10 mg PO , use as directed No 30 quantity

"use as directed" is used in lieu of frequency
Not a common usage but will happen.

This cann't go into 2nd <effectivetime> element in medication section which requires only EIVL_TS or PIVL_TS.

Can we add this in <entryrelationship> under criterion using <originaltext>?

Or is there some other way to represent this

Kumara

---

From: Kumara Prathipati <kuma...@yahoo.com>
To: Tom de Jong <t...@nova-pro.nl>; 'Benjamin Flessner' <Benj...@epic.com>; "'Boone, Keith W (GE Healthcare)'" <keith...@ge.com>; 'Brian Weiss' <brian...@cdapro.com>; "ccda_s...@googlegroups.com" <ccda_s...@googlegroups.com>
Cc: 'Structured Documents WG' <stru...@lists.hl7.org>; "phar...@lists.hl7.org" <phar...@lists.hl7.org>
Sent: Friday, July 12, 2013 11:13 AM
Subject: Re: MEDICATION SECTION EVIL_TS VOCABUALRY set url

Tom,

Thanks for the help with EIVL_TS data type vocabulary value set.
Are these 2 below examples accurate or did I make any mistakes?

Kumara


//lunch time//
<effectiveTime xsi:type="EIVL_TS" operator="A">
<event code="CD"/>
</effectiveTime>


//1 HR BEFORE LUNCH//
<effectiveTime xsi:type="EIVL_TS" operator="A">
<event code="CD"/>
<offset>
    <low value='-1' unit='h'/>
</offset>
</effectiveTime>

[Kumara Prathipati]

Inside medication section..

<repeatnumber> concept is confusing...

We all know what is refill number.

If a doctor writes

xyz tablet 10 mg PO, take 1 tablet three times daily (TID) No 100, refill 3

That means
Pharmacist will dispense 100 tablets total 4 times (total 400 tablets. (first prescription + 3 more times)

Where does this repeat number element fit in this scenario...
The CCDA IG says refill number is not same as repeat number.
=====================================================

I have another scenario

Nitroglycerine 0.4 mg under tongue (SL) take for chest pain every 5 minutes (repeat total 3 times) up to maximum 3 times total.
(if pain still exists call 911)

Can some one explain repeat  number concept with a couple of different examples.
Or appreciate if some one can point me to a good  URL to read more.

Kumara

[Lloyd McKenzie]

Hi Kumara,

repeatNumber always indicates the total number of repetitions.  So if talking about ordered dispenses as part of a prescription, it would be equal to the total authorized number of fills - or # of authorized refills +1.

In your second example, you'd need to use the data type URG<INT>, which would allow you to specify both a minimum (1) and maximum (3) number of repetitions.

Lloyd

--------------------------------------
Lloyd McKenzie

+1-780-993-9501

 

Note: Unless explicitly stated otherwise, the opinions and positions expressed in this e-mail do not necessarily reflect those of my clients nor those of the organizations with whom I hold governance positions.

[Lloyd McKenzie]

Hi Kumara,

Unfortunately you *can't* represent that in CDA using just EIVL_TS.  Apparently sex isn't considered an "activity of daily living" - or at least not one predictable enough for general timing use :>

The solution is to note "sex" as a precondition to the substance administration using the PRCN act relationship.  You would indicate the "15 minutes" using the ActRelationship.pauseQuantity attribute.  To be completely accurate, the 1 to 2 times per week should actually be on an encompassing act, because what you really want to say is "Once to twice a week, take 50mg 15 minutes before sex".  If you put the 1-2/week on the act with the precondition, then it would say "Once the precondition of 15 minutes before sex has been met, take 50mg 1-2 times per week", which isn't what you're really looking for.  As I look at it more, you're really wanting to say "this needs to happen a minimum of once/week", which is what a frequency of 1-2/week is stating (though I'm sure some patients might be happy to make such an argument to their spouses :>).  What you're really wanting to do is set a maximum frequency.  We could do that either by just setting a maximum frequency on the encompassing act and omitting the minimum or by specifying a maximum dosage.  I've chosen the latter approach, but either will work..

So the result would be something like this: (I haven't validated against the schema, so excuse minor typos)

<substanceAdministration classCode="SBADM" moodCode="RQO">

  <doseQuantity value="50" unit="mg"/>

  <maxDoseQuantity>

    <numerator value="100" unit="mg"/>

    <denominator value="1" unit="w"/>

  </maxDoseQuantity>

  <consumable>

    <!-- Drug goes here -->

  </consumable>

  <precondition typeCode="PRCN">

    <pauseQuantity value="15" unit="min"/>

    <observation classCode="OBS" moodCode="EVN.CRIT">

      <!-- We use EVN.CRIT because CDA doesn't have access to the isCriterion attribute -->

      <text>sexual activity</text>

      <!-- I'm sure there's a SNOMED code for this so you could send code = Assertion, value = appropriate SNOMED code, but I'm lazy and it's not as though you expect a decision support system to trigger on the event - especially given that the trigger would require a degree of precognition . . . -->

    </observation>

  </precondition>

</substanceAdministration>

I believe all of the above is available and legal within CDA, though it's best to verify.

Lloyd

--------------------------------------
Lloyd McKenzie

+1-780-993-9501

 

Note: Unless explicitly stated otherwise, the opinions and positions expressed in this e-mail do not necessarily reflect those of my clients nor those of the organizations with whom I hold governance positions.

On Fri, Jul 12, 2013 at 2:19 PM, Kumara Prathipati <kuma...@yahoo.com> wrote:

Tom,

I have another example of frequency where i am lost...

"Viagra 50 mg tablet by mouth , 15 minutes before sex , 1 to 2 times a week."
How do I represent this in<effectivetime> EIVL_TS data type?

The official recommendation is as follows...
For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, VIAGRA (sildenafil citrate) may be taken anywhere from 4 hours to 0.5 hour before sexual activity.

Kumara

[Tom de Jong]

Hi Lloyd,

 

You wrote:

Ø  In your second example, you'd need to use the data type URG<INT>, which would allow you to specify both a minimum (1) and maximum (3) number of repetitions.

 

I don’t think URG_INT is available in data types R1, is it? The next best thing is using IVL_INT, which technically has a different meaning (implying ALL values between <low> and <high>, instead of ONE of the values), but we know this has been used in many cases where URG_INT should be used (when available in data types R2).

 

Best,

Tom

[Lloyd McKenzie]

Hi Tom,

You're right.  And unlike URG, you can't introduce IVL where-ever you want.

--------------------------------------
Lloyd McKenzie

+1-780-993-9501

 

Note: Unless explicitly stated otherwise, the opinions and positions expressed in this e-mail do not necessarily reflect those of my clients nor those of the organizations with whom I hold governance positions.

[Tom de Jong]

No, you can’t, but Kumara was talking about <repeatNumber>, which is IVL_INT in the CDA R2 model, so it would certainly be available there…