The HL7 Structured Documents workgroup had on its agenda to discuss updates to C-CDA 1.1 and 2.1 to address Allergy Criticality and Severity. I first mentioned this problem at the end of last month.
Today, we discussed this in committee and with John Quinn, the HL7 CTO (who must approve errata), and agreed to address this issue as errata in the CCDA 2.1 DSTU Update project. Once again, HL7 has shown that they can be responsive in addressing a critical issue. I'm pleased to see this, and can only hope that we don't wind up being so responsive that we need to institute Bureau of Sabotage.
Effectively what we will be doing in CCDA 2.1 DSTU Update project is create a new template to support criticality, and deprecating use of Severity template on the allergy itself.
-- Keith
For those who aren't familiar with the issue, I will reproduce the important content below:
The PCWG has many other DSTU comments – however, we are
writing to ensure that the criticality concept is included without delay in the
C-CDA templates.
Today, we discussed this in committee and with John Quinn, the HL7 CTO (who must approve errata), and agreed to address this issue as errata in the CCDA 2.1 DSTU Update project. Once again, HL7 has shown that they can be responsive in addressing a critical issue. I'm pleased to see this, and can only hope that we don't wind up being so responsive that we need to institute Bureau of Sabotage.
Effectively what we will be doing in CCDA 2.1 DSTU Update project is create a new template to support criticality, and deprecating use of Severity template on the allergy itself.
-- Keith
For those who aren't familiar with the issue, I will reproduce the important content below:
The stated project need for SDWG project 1014 is “Proposed US federal regulation has
identified C-CDA 2.0 as being the preferred way forward, but introduces a need
for compatibility that was not anticipated for in the original project
scope. An update is needed to ensure
that new templates are backwards compatible.
Existing Consolidated
CDA (C-CDA) needs to be enhanced by adding templates to represent priority data
elements, and modified/new section level and document level templates needed for
transitions of care and care plans, areas essential to patient care and the
meaningful use of EHRs; we need to incorporate errata; and we want to address
areas that implementers have found to be ambiguous.” Patient Care is a co-sponsor of this
project originally approved in 2013. The
TSC approved the updated project scope statement on June 9, 2015.
The Patient Care Work Group (PCWG) has been working on the
Allergy and Intolerance topic to update and harmonize standards since
2010. The products related to this work
include an Allergy
and Intolerance Domain Analysis Model, Allergy
and Intolerance Clinical Models (DSTU) and an Allergy and
Intolerance FHIR resource. In order
to ensure harmonization across HL7 standards, the Patient Care WG conducted an
extensive review of C-CDA R1.1 and R2.0.
During this review, the PCWG presented on-going issues to the SDWG at
two face-to-face sessions (most recently at the Paris WG meeting) in order to reinforce
the findings and recommendations of this year-long analysis of known C-CDA issues. The results of this analysis were posted as
DSTU comments for C-CDA R1.0
(Comment 643) and C-CDA R2.0
(Comment 644). At the request of the
SDWG, multiple comments were submitted against each C-CDA version in tabular
format. This summary document can also
be found on the Patient Care wiki: C-CDA
Harmonization Table.
The Issue
Patient Care has kept the SDWG apprised of work in the area
of Allergies and Intolerances since this work began in 2010. Multiple presentations on this topic were given
at each Work Group meeting (see minutes from each joint PCWG/SDWG Thursday
Q2). As the PC WG harmonization process
continued, it was apparent that the C-CDA did not recognize some of the
concepts within the PCWG DAM or clinical models, or the FHIR allergy and
intolerance resource. Working with a primary
representative and additional representatives from the SDWG, the PCWG has
diligently outlined and proposed solutions to ensure harmonization all of the
HL7 products that address allergies and intolerances. This has included extensive terminology work
in coding systems including HL7, SNOMED CT and LOINC.
Extensive comments and recommendations were posted to the
DSTU website for both C-CDA R1.1 and R2.0, with the expectation that these
comments would be duly considered during the current review of errata and
backwards compatibility issues. Comments
from the PCWG are substantive and seek to ensure that the use of C-CDA provides
clinically correct data exchange between providers.
On Thursday, June 25, the Patient Care WG presented a
synthesis of these comments to the SDWG.
The most significant issue at hand relates to the use of the Severity
Template in two contexts related to the Allergy and Intolerance Observation and
the Reaction Observation.
The current relationship of the Severity Template is shown
in this diagram taken from C-CDA R1.1.
This relationship is retained in R2.0:
The relationship between the allergy observation and severity is
erroneous, is creating confusion through ambiguity and does not reflect the
current relationships in other HL7 allergy and intolerance standards.
The PCWG Allergy and Intolerance DAM and Clinical Models as
well as the FHIR resource have a different relationship.
A reaction is correctly described by severity, e.g. a
patient had a mild reaction to a drug, or a severe reaction to a food. However, the allergic condition is not
described in terms of severity, rather the term criticality. The concept of
criticality is in the RIM as the code “CRIT”[1]
in ActCode/ObservationType, and is associated with the allergic or intolerant
condition.
The definition of criticality
as per the PCWG is as follows: A clinical judgment as to the worst case
result of a future exposure (including substance administration). When the
worst case result is assessed to have a life-threatening or organ system
threatening potential, it is considered to be of high criticality.
It is important to note that there is not a 1:1 relationship
between the severity of a reaction and the criticality of the condition. For example a patient might have a severe
reaction to a medication (nausea) however that condition has a low criticality –
e.g. the medication can still be prescribed if medically indicated. Conversely, a child may have a mild reaction
on the first exposure to a peanut, however a repeat exposure to peanuts may be
life threatening and therefore of high criticality.
After the presentation by the PCWG on June 25 to the SDWG,
the group discussed the issues at hand for some 30 minutes. Despite an acknowledgement of the issues, no
resolution was proposed nor voted on by the SDWG.
Patient Safety and
Clinical Practice
Currently the use of severity in the context of a reaction and
also in the context of a condition has the following potential consequences in
systems exchanging information on allergies and intolerances:
1. Patient safety issue: When a system reports an allergic or
intolerant reaction with mild severity but which is associated with a condition
of high criticality (e.g. the risk of a life threatening reaction), based on
severity alone a receiving system could allow an order to be processed for a
drug or medication that should not be prescribed. The current construct in the C-CDA does not
capture or convey the correct information to mitigate this risk.
2. The current construct does not allow for the most effective treatment: A patient may report a severe reaction to a medication, such as “severe nausea” – however, nausea in most cases is of low criticality. A similar example is the common reaction to epinephrine (adrenaline) where most patients would describe their nausea, vomiting and sweating as severe – but if adrenaline is clinically indicated, it will be prescribed. The current C-CDA construct is unable to correctly convey this information.
3. Alert fatigue: Clinicians often complain of alert fatigue, including for alerts for the severity of an allergic condition, since it is a spurious concept. Given the documented drug-allergy alert override rate of around 90%[2], the use of criticality will clearly convey issues that require a careful consideration of the clinical options.
2. The current construct does not allow for the most effective treatment: A patient may report a severe reaction to a medication, such as “severe nausea” – however, nausea in most cases is of low criticality. A similar example is the common reaction to epinephrine (adrenaline) where most patients would describe their nausea, vomiting and sweating as severe – but if adrenaline is clinically indicated, it will be prescribed. The current C-CDA construct is unable to correctly convey this information.
3. Alert fatigue: Clinicians often complain of alert fatigue, including for alerts for the severity of an allergic condition, since it is a spurious concept. Given the documented drug-allergy alert override rate of around 90%[2], the use of criticality will clearly convey issues that require a careful consideration of the clinical options.
In addition to the DSTU comments prepared by the PCWG, the
C-CDA R2 ballot comments included a comment on the use of severity in two
contexts. The reconciliation spreadsheet
for the 2013 ballot (Comment 290) noted under the disposition that SDWG would
consult with the Allergy and Intolerance DAM.
However the final disposition reads as follows: "In
CCD.xml, add commenting [sic] which relates to the description in the severity
template: ""When the Severity Observation is associated directly with
an allergy it characterizes the allergy. When the Severity Observation is
associated with a Reaction Observation it characterizes a Reaction." This statement is incorrect, and it is
unfortunate that the use of criticality (a concept currently existing in the
RIM) was not considered.
The C-CDA R2.1
Project
SDWG is considering candidate errata for C-CDA 2.1, a
project designed to ensure backwards compatibility from R2.0 to R1.1 based on
considerations related to the Meaningful Use 3 NPRM. The project wiki is here: http://wiki.hl7.org/index.php?title=Consolidated_CDA_R2.1_DSTU_Update
and the need for the project opinion is here: http://motorcycleguy.blogspot.com/2015/05/tell-onc-to-use-ccda-21-for-stage3-2015.html
What are errata?
The SDWG has discussed what errata are: (the post is the opinion
of the author) http://motorcycleguy.blogspot.com/2013/03/defining-errata.html
The Chicago Manual of Style defines errata as follows:
"Errata, lists of errors and their corrections, may take the form of
loose, inserted sheets or bound-in pages. An errata sheet is definitely not a
usual part of a book. It should never be supplied to correct simple
typographical errors (which may be rectified in a later printing) or to insert
additions to, or revisions of, the printed text (which should wait for the next
edition of the book). It is a device to
be used only in extreme cases where errors severe enough to cause
misunderstanding are detected too late to correct in the normal way but before
the finished (book) is distributed. Then the errors may be listed with
their locations and their corrections on a sheet that is tipped in, either
before or after the book is bound, or laid in loose, usually inside the front
cover of the book.
Reference: Chicago
Manual of Style: (referenced June 28,
2015) http://www.chicagomanualofstyle.org/home.html
Is the issue of criticality an erratum? The PCWG feels that the omission of the
criticality concept is of sufficient gravity to qualify as an erratum that must
be considered in the current C-CDA 2.1 process.
The risk of not dealing with the criticality issue at this time is that
the Meaningful Use 3 standard will point to a version of the C-CDA that is
clinically incorrect and has the potential to cause patient harm.
The PCWG understands the alacrity with which the errata
process must occur to meet federal timelines.
The current timeline for C-CDA DSTU errata review is due to begin on
July 1 and end on July 10th, 2015.
While the HL7
Governance and Operations Manual describes the process for submission of
DSTU errata to the HL7 CTO, the PCWG appeals to the HL7 SDWG to duly consider
this request prior to finalizing C-CDA 2.1 comments through the DSTU errata
process. Normally such an activity would
be balloted allowing for broad member comment.
Outcome Requested
The C-CDA is cited as the means to support health
information exchange within the NPRM[3]
for MU 3. HL7 needs to ensure that the
information exchanged is correct, based on current standards such as the RIM,
and responsibly mitigates the risk of ambiguous and clinically incorrect
information. The Patient Care WG respectfully requests that the concept of
criticality be added to the C-CDA standard as an erratum because of the risk of
patient harm.
While the addition of a criticality template to C-CDA would
be the most complete solution to this issue, there are several other paths
forward:
1. At a minimum: Change the incorrectly referenced severity
template to SHOULD NOT at the Allergy Intolerance Observation level.
2. If possible: Add a MAY conformance to the Allergy
Intolerance Observation that permits use of the Criticality Observation.
The PCWG stands ready to assist with this endeavor.
Respectfully submitted by the Patient Care WG Allergy and
Intolerance Project Team,
[1]
The current RIM definition of criticality is: CRIT (criticality) An observation representing a clinical judgment as
to the worst case result of a future occurrence or the evolution of a current
occurrence. It would be based on the severity of past occurrences, the details
of what produced the past occurrences and the life-threatening or organ system
threatening potential of the observation type. The PCWG has a harmonization request pending
to update this definition.
[2] Bryant, AD, Fletcher, GS,
Payne, TH. Drug Interaction override
rates in the Meaningful Use era – no evidence of progress. App Clin Infor 2014:5(3);802-813 http://www.ncbi.nlm.nih.gov/pubmed/25298818
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