The
findings
and
interpretation
of
diagnostic
tests
performed
on
patients,
groups
of
patients,
devices,
and
locations,
and/or
specimens
derived
from
these.
The
report
includes
clinical
context
such
as
requesting
and
provider
information,
and
some
mix
of
atomic
results,
images,
textual
and
coded
interpretations,
and
formatted
representation
of
diagnostic
reports.
The findings and interpretation of diagnostic tests performed on patients, groups of patients, devices, and locations, and/or specimens derived from these. The report includes clinical context such as requesting and provider information, and some mix of atomic results, images, textual and coded interpretations, and formatted representation of diagnostic reports.
4.21.1
Scope
and
Usage
10.2.1
Scope and Usage A
diagnostic
report
is
the
set
of
information
that
is
typically
provided
by
a
diagnostic
service
when
investigations
are
complete.
The
information
includes
a
mix
of
atomic
results,
text
reports,
images,
and
codes.
The
mix
varies
depending
on
the
nature
of
the
diagnostic
procedure,
and
sometimes
on
the
nature
of
the
outcomes
for
a
particular
investigation.
In
FHIR,
the
report
can
be
conveyed
in
a
variety
of
ways
including
a
This resource is an
event
resource from a FHIR workflow perspective - see
Workflow
. It is the intent of the Orders and Observation Workgroup to align this resource with the workflow pattern for
event
resources.
The DiagnosticReport resource has information about the diagnostic report itself, and about the subject and, in the case of lab tests, the specimen of the report. It can also refers to the request details and atomic observations details or image instances. Report conclusions can be expressed as a simple text blob, structured coded data or as an attached fully formatted report such as a PDF.
The DiagnosticReport resource is suitable for the following kinds of diagnostic reports:
Other diagnostics - Cardiology, Gastroenterology etc.
The DiagnosticReport resource is not intended to support cumulative result presentation (tabular presentation of past and present results in the resource). The DiagnosticReport resource does not yet provide full support for detailed structured reports of sequencing; this is planned for a future release.
4.21.2
Background
and
Context
10.2.2
Background and Context Diagnostic
Report
Names
The
words
"tests",
"results",
"observations",
"panels"
and
"batteries"
are
often
used
interchangeably
when
describing
the
various
parts
of
a
diagnostic
report.
This
leads
to
much
confusion.
The
naming
confusion
is
worsened
because
of
the
wide
variety
of
forms
that
the
result
of
a
diagnostic
investigation
can
take,
as
described
above.
Languages
other
than
English
have
their
own
variations
on
this
theme.
This
resource
uses
one
particular
set
of
terms.
A
practitioner
"requests"
a
set
of
"tests".
The
diagnostic
service
returns
a
"report"
which
may
contain
a
"narrative"
-
a
written
summary
of
the
outcomes,
and/or
"results"
-
the
individual
pieces
of
atomic
data
which
each
are
"observations".
The
results
are
assembled
in
"groups"
which
are
nested
structures
of
Observations
(traditionally
referred
to
as
"panels"
or
"
batteries"
by
laboratories)
that
can
be
used
to
represent
relationships
between
the
individual
data
items.
Diagnostic Report Names
The words "tests", "results", "observations", "panels" and "batteries" are often used interchangeably when describing the various parts of a diagnostic report. This leads to much confusion. The naming confusion is worsened because of the wide variety of forms that the result of a diagnostic investigation can take, as described above. Languages other than English have their own variations on this theme.
This resource uses one particular set of terms. A practitioner "requests" a set of "tests". The diagnostic service returns a "report" which may contain a "narrative" - a written summary of the outcomes, and/or "results" - the individual pieces of atomic data which each are "observations". The results are assembled in "groups" which are nested structures of Observations (traditionally referred to as "panels" or " batteries" by laboratories) that can be used to represent relationships between the individual data items.
4.21.3
Boundaries
and
Relationships
10.2.3
Boundaries and Relationships Note
that
many
diagnostic
processes
are
procedures
that
generate
observations
and
diagnostic
reports.
In
many
cases,
such
an
observation
does
not
require
an
explicit
representation
of
the
procedure
used
to
create
the
observation,
but
where
there
are
details
of
interest
about
how
the
diagnostic
procedure
was
performed,
the
If you have a highly structured report, then use DiagnosticReport - it has data and workflow support. Details about the request for a diagnostic investigation are captured in the various "request" resources (e.g., the
DiagnosticRequest
)
resource
and
allow
the
report
to
connect
to
clinical
workflows.
For
more
narrative
driven
reports
with
less
work
flow
(histology/mortuary,
etc.),
the
) resource and allow the report to connect to clinical workflows. For more narrative driven reports with less work flow (histology/mortuary, etc.), the
Composition
resource
would
be
more
appropriate.
DSTU
Note:
The
relationship
between
the
two
resources
is
subject
to
ongoing
evaluation
during
the
trial
use
period.
Feedback
is
welcome
here
resource would be more appropriate.
DSTU Note:
The relationship between the two resources is subject to ongoing evaluation during the trial use period.
A
Diagnostic
report
-
a
combination
of
request
information,
atomic
results,
images,
interpretation,
as
well
as
formatted
reports
A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
A
Diagnostic
report
-
a
combination
of
request
information,
atomic
results,
images,
interpretation,
as
well
as
formatted
reports
A Diagnostic report - a combination of request information, atomic results, images, interpretation, as well as formatted reports
Examples of nested report groups: the antibody hepatitis order panel code for a group of hepatitis antibody related tests, or the organism code for a group of antibiotic isolate/sensitivities, or a set of perinatal measurements on a single fetus.
4.21.5
Notes:
10.2.5
Notes:
4.21.5.1
10.2.5.1
Clinically
Relevant
Time
Clinically Relevant Time If
the
diagnostic
procedure
was
performed
on
the
patient
directly,
the
effective[x]
element
is
a
dateTime,
the
time
it
was
performed.
If
specimens
were
taken,
the
clinically
relevant
time
of
the
report
can
be
derived
from
the
specimen
collection
times,
but
since
detailed
specimen
information
is
not
always
available,
and
nor
is
the
clinically
relevant
time
always
exactly
the
specimen
collection
time
(e.g.
complex
timed
tests),
the
reports
SHALL
always
include
a
If the diagnostic procedure was performed on the patient directly, the
effective[x]
element.
Note
that
HL7
v2
element is a dateTime, the time it was performed. If specimens were taken, the clinically relevant time of the report can be derived from the specimen collection times, but since detailed specimen information is not always available, and nor is the clinically relevant time always exactly the specimen collection time (e.g. complex timed tests), the reports SHALL always include a effective[x] element. Note that
HL7 v2 messages
often
carry
a
diagnostically
relevant
time
without
carrying
any
specimen
information.
messages often carry a diagnostically relevant time without carrying any specimen information.
4.21.5.2
10.2.5.2
Associated
Observations
Associated Observations The
DiagnosticReport.code
always
contains
the
name
of
the
report
itself.
The
report
can
also
contain
a
set
of
Observations
in
the
DiagnosticReport.result
element.
These
Observations
can
be
simple
observations
(e.g.
atomic
results)
or
groups/panels
of
other
observations.
The
Observation.code
indicates
the
nature
of
the
observation
or
panel
(e.g.
individual
measure,
organism
isolate/sensitivity
or
antibody
functional
testing).
When
relevant,
the
observation
can
specify
a
particular
specimen
from
which
the
result
comes.
Examples
of
nesting
groups/panels
within
an
observation
include
reporting
a
"profile"
consisting
of
several
panels
as
is
shown
in
this
example
,
a
group
of
antibiotic
isolate/sensitivities
for
a
bacterial
culture,
or
a
set
of
perinatal
measurements
on
a
single
fetus.
There
is
rarely
a
need
for
more
than
two
levels
of
nesting
in
the
Observation
tree.
One
known
use
is
for
organism
sensitivities
-
an
example
of
a
complex
Micro
Isolate
and
Sensitivities
is
provided.
The DiagnosticReport.code always contains the name of the report itself. The report can also contain a set of Observations in the DiagnosticReport.result element. These Observations can be simple observations (e.g. atomic results) or groups/panels of other observations. The Observation.code indicates the nature of the observation or panel (e.g. individual measure, organism isolate/sensitivity or antibody functional testing). When relevant, the observation can specify a particular specimen from which the result comes.
Examples of nesting groups/panels within an observation include reporting a "profile" consisting of several panels as is shown in
this example
, a group of antibiotic isolate/sensitivities for a bacterial culture, or a set of perinatal measurements on a single fetus.
There is rarely a need for more than two levels of nesting in the Observation tree. One known use is for organism sensitivities - an example of a
complex Micro Isolate and Sensitivities
is provided.
4.21.5.3
10.2.5.3
Associated
Images
Associated Images ImagingStudy
and
ImageObjectStudy
and
the
DiagnosticReport.image
element
are
somewhat
overlapping
-
typically,
the
list
of
image
references
in
the
image
element
will
also
be
found
in
one
of
the
imaging
study
resources.
However
each
caters
to
different
types
of
displays
for
different
types
of
purposes.
Neither,
either,
or
both
may
be
provided.
ImagingStudy and ImageObjectStudy and the DiagnosticReport.image element are somewhat overlapping - typically, the list of image references in the image element will also be found in one of the imaging study resources. However each caters to different types of displays for different types of purposes. Neither, either, or both may be provided.
4.21.5.4
10.2.5.4
Diagnostic
Report
Status
Diagnostic Report Status Applications
consuming
diagnostic
reports
must
take
careful
note
of
updated
(revised)
reports,
and
ensure
that
retracted
reports
are
appropriately
handled.
For
applications
providing
diagnostic
reports,
a
report
should
not
be
final
until
all
the
individual
data
items
reported
with
it
are
final
or
amended.
If
the
report
has
been
withdrawn
following
a
previous
final
release,
the
DiagnosticReport
and
associated
Observations
should
be
retracted
by
replacing
the
status
codes
with
the
concept
"entered-in-error",
and
setting
the
conclusion/comment
(if
provided)
and
the
text
narrative
to
some
text
like
"This
report
has
been
withdrawn"
in
the
appropriate
language.
A
reason
for
retraction
may
be
provided
in
the
narrative.
Applications consuming diagnostic reports must take careful note of updated (revised) reports, and ensure that retracted reports are appropriately handled.
For applications providing diagnostic reports, a report should not be final until all the individual data items reported with it are final or amended.
If the report has been withdrawn following a previous final release, the DiagnosticReport and associated Observations should be retracted by replacing the status codes with the concept "entered-in-error", and setting the conclusion/comment (if provided) and the text narrative to some text like "This report has been withdrawn" in the appropriate language. A reason for retraction may be provided in the narrative.
4.21.5.5
10.2.5.5
Report
Content
Report Content This
resource
provides
for
3
different
ways
of
presenting
the
Diagnostic
Report:
As
atomic
data
items:
a
hierarchical
set
of
nested
references
to
Observation
resources
often
including
pathologist/radiologist
interpretation(s),
one
or
more
images,
and
possibly
with
a
conclusion
and/or
one
or
more
coded
diagnoses
As
narrative:
an
XHTML
presentation
in
the
standard
resource
narrative
As
a
"presented
form":
A
rich
text
representation
of
the
report
-
typically
a
PDF
Note
that
the
conclusion
and
the
coded
diagnoses
are
part
of
the
atomic
data,
and
SHOULD
be
duplicated
in
the
narrative
and
in
the
presented
form
if
the
latter
is
present.
The
narrative
and
the
presented
form
serve
the
same
function:
a
representation
of
the
report
for
a
human.
The
presented
form
is
included
since
diagnostic
service
reports
often
contain
presentation
features
that
are
not
easy
to
reproduce
in
the
HTML
narrative.
Whether
or
not
the
presented
form
is
included,
the
narrative
must
be
a
clinically
safe
view
of
the
diagnostic
report;
at
a
minimum,
this
could
be
fulfilled
by
a
note
indicating
that
the
narrative
is
not
proper
representation
of
the
report,
and
that
the
presented
form
must
be
used,
or
a
generated
view
from
the
atomic
data.
However
consumers
of
the
report
will
best
be
served
if
the
narrative
contains
clinically
relevant
data
from
the
form.
Commonly,
the
following
patterns
are
used:
Simple
Laboratory
Reports:
A
single
set
of
atomic
observations,
and
a
tabular
presentation
in
narrative.
Typically
this
is
encountered
in
high
volume
areas
such
as
Biochemistry
and
Hematology
Histopathology
Report:
A
document
report
in
a
presented
form
and
the
narrative.
Possibly
a
few
key
images,
and
some
coded
diagnoses
for
registries.
If
the
service
is
creating
a
structured
report,
some
atomic
data
may
be
included
imaging
Report;
A
document
report
in
a
presented
form
and
the
narrative,
with
an
imaging
study
reference
and
possibly
some
key
images.
Some
imaging
reports
such
as
a
Bone
Density
Scan
may
include
some
atomic
data
Note
that
the
nature
of
reports
from
the
various
disciplines
that
provide
diagnostic
reports
are
changing
quickly,
as
expert
systems
provide
improved
narrative
reporting
in
high
volume
reports,
structured
reporting
brings
additional
data
to
areas
that
have
classically
been
narrative
based,
and
the
nature
of
the
imaging
and
laboratory
procedures
are
merging.
As
a
consequence
the
patterns
described
above
are
only
examples
of
how
a
diagnostic
report
can
be
used.
Typically, a report is either:all data, no narrative (e.g. Core lab) or a mix of data with some concluding narrative (e.g. Structured Pathology Report, Bone Density), or all narrative (for example a typical imaging report, histopathology). This resource provides for these 3 different presentations:
As atomic data items: a hierarchical set of nested references to Observation resources often including pathologist/radiologist interpretation(s), one or more images, and possibly with a conclusion and/or one or more coded diagnoses
As narrative: an XHTML presentation in the standard resource narrative
As a "presented form": A rich text representation of the report - typically a PDF
Note that the conclusion and the coded diagnoses are part of the atomic data, and SHOULD be duplicated in the narrative and in the presented form if the latter is present. The narrative and the presented form serve the same function: a representation of the report for a human. The presented form is included since diagnostic service reports often contain presentation features that are not easy to reproduce in the HTML narrative. Whether or not the presented form is included, the narrative must be a clinically safe view of the diagnostic report; at a minimum, this could be fulfilled by a note indicating that the narrative is not proper representation of the report, and that the presented form must be used, or a generated view from the atomic data. However consumers of the report will best be served if the narrative contains clinically relevant data from the form. Commonly, the following patterns are used:
Simple Laboratory Reports: A single set of atomic observations, and a tabular presentation in narrative. Typically this is encountered in high volume areas such as Biochemistry and Hematology
Histopathology Report: A document report in a presented form and the narrative. Possibly a few key images, and some coded diagnoses for registries. If the service is creating a structured report, some atomic data may be included
imaging Report; A document report in a presented form and the narrative, with an imaging study reference and possibly some key images. Some imaging reports such as a Bone Density Scan may include some atomic data
Note that the nature of reports from the various disciplines that provide diagnostic reports are changing quickly, as expert systems provide improved narrative reporting in high volume reports, structured reporting brings additional data to areas that have classically been narrative based, and the nature of the imaging and laboratory procedures are merging. As a consequence the patterns described above are only examples of how a diagnostic report can be used.
4.21.6
Search
Parameters
10.2.6
Search Parameters Search
parameters
for
this
resource.
The
common
parameters
also
apply.
See
The
code
for
the
report
as
a
whole,
as
opposed
to
codes
for
the
atomic
results,
which
are
the
names
on
the
observation
resource
referred
to
from
the
result
The code for the report as a whole, as opposed to codes for the atomic results, which are the names on the observation resource referred to from the result
Diagnostics
DiagnosticReport
identifier
status
subject
effective[x]
image
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