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‎10.4.2.1.3 Single Report Text Example

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‎10.3 APSR Required Actor Groupings

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‎10.3 APSR Required Actor Groupings

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‎10.4.1 Concepts

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==10 Anatomic Pathology Structured Report (APSR) Profile==

This content profile describes an
anatomic pathology structured report (APSR) as a digital document to be shared or
exchanged between pathology laboratories and other care providers and
institutions.

Anatomic pathology structured reports
document the findings on specimens removed from patients for diagnostic or
therapeutic reasons. This information can be used for patient care, clinical
research and epidemiology. Standardizing and computerizing anatomic pathology
reports is necessary to improve the quality of reporting and to facilitate the
exchange and reuse of the content of these reports.

This content profile describes a digital
anatomic pathology report shared in a human-readable format, which may include
images, and which also contains findings and observations in a machine-readable
format, to facilitate the integration of these into the database of a consumer
system, and to enable the application of automated reasoning to this content.

The scope of this IHE content profile covers all fields
of anatomic pathology (cancers, benign neoplasms as well as non-neoplastic
conditions) as well as cytopathology.

Goldsmith J.D. et al.<ref>Goldsmith, J.D., et al., “Reporting
guidelines for clinical laboratory reports in surgical pathology” Arch Pathol
Lab Med, 2008. 132(10): p. 1608-16</ref> is the first source of specification for
this content profile. This article delineates the required, preferred, and
optional elements which should be included in any report of surgical pathology.

This source is complemented by the
“Cancer Checklists” produced by the College of American Pathologists<ref>http://www.cap.org/web/oracle/webcenter/portalapp/pagehierarchy/cancer_protocol_templates.jspx?_adf.ctrl-state=e1f4ltym4_4&_afrLoop=275425457234715#!</ref>, and by
the “comptes rendus d’anatomopathologie : données minimales à renseigner pour
une tumeur primitive” produced by the French society of pathology (SFP<ref> http://www.sfpathol.org</ref>)
for the French cancer institute (INCa <ref>http://www.e-cancer.fr</ref>), and by the German "Guideline Pathology / Neuropathology" (formerly TM-30) of the Sector Committee Pathology for the implementation of DIN EN ISO/EC 17020.

This profile has also benefited from the
guidance on cancer AP reports provided by the North-American Association of
Central Cancer Registries; some of the example snippets captured in the profile
leverage the NAACCR Standards for Cancer Registries, Volume V, Pathology
Laboratory Electronic Reporting.

== 10.1 APSR Actors/Transactions ==

This
section defines the actors, transactions, and/or content modules in this
profile. General definitions of actors are given in the Technical Frameworks
General Introduction Appendix A published here.

Figure 10.1-1
shows the actors directly involved in the APSR Profile and the direction that
the content is exchanged.

A
product implementation using this profile must group actors from this profile
with actors from a workflow or transport profile to be functional. The grouping
of the content module described in this profile to specific actors is described
in more detail in the “Required Actor Groupings” section below.

[[Datei:fig.4.1.-1.jpg]]

Figure 10.1-1 APSR Actor Diagram

Table 10.1-1 lists the content module(s)
defined in the APSR profile. To claim support with this profile, an actor shall
support all required content modules (labeled “R”) and may support optional
content modules (labeled “O”).

'''Table 10.1-1: <Profile Acronym>Profile - Actors and Content Modules'''
{| class="hl7table"
!Actors !! Content Modules !! Optionality !! Reference
|-
|Content
Creator
||
Anatomic Pathology Structured Report
1.3.6.1.4.1.19376.1.8.1.1.1
|| R
||PaLM TF-3: 6.3.1.2
|-
|Content
Consumer
||
Anatomic Pathology Structured Report
1.3.6.1.4.1.19376.1.8.1.1.1
|| R
||PaLM TF-3: 6.3.1.2
|-
|}

=== 10.1.1 Actor Descriptions and Actor Profile Requirements===

Most requirements are documented in
Content Modules (Volume 3). This section documents any additional requirements
on profile’s actors.

==10.2 APSR Actor Options==

Options that may be selected for each
actor in this profile are listed in the table 10.2-1. These options are further
detailed in PCC Technical Framework Volume 2 as indicated in the rightmost
column.

'''Table 10.2-1 Anatomic Pathology Structured Report - Actors and Options'''

{| class="hl7table"
!Actor !! Option Name !! Reference
|-
|Content
Creator
||''None''
||
|-
|Content
Consumer
||''View Option (1)''
''Document Import Option (1)''

''Section Import Option (1)''
||PCC TF-2:3.1.1
PCC TF-2:3.1.2

PCC TF-2:3.1.3
|-
|}
''Note 1: The Content Consumer Actor shall support at
least one of these options.''

==10.3 APSR Required Actor Groupings ==

An Actor from this profile (Column 1)
shall implement all of the required transactions and/or content modules in this
profile in addition to all of the transactions required for the grouped
actor (Column 2).

In some cases, required groupings are
defined as at least one of an enumerated set of possible actors; this is
designated by merging column one into a single cell spanning multiple potential
grouped actors. Notes are used to highlight this situation.

Section 10.5 describes some optional
groupings that may be of interest for security considerations and section 10.6
describes some optional groupings in other related profiles.

'''Table 10.3-1: Anatomic Pathology Structured Report - Required Actor Groupings'''
{| class="hl7table"
!XD-LAB Actor !! Actor to be grouped with !! Reference !! Content Bindings Reference
|-
|Content
Creator
||
ITI XDS.b
Document Source

OR

ITI XDM Portable Media Creator

OR

ITI XDR Document
Source
||
ITI TF-1:10

ITI TF-1:16

ITI TF-1:15
||
|-
|Content
Consumer
||
ITI XDS.b Document Consumer

OR

ITI XDM Portable Media Consumer

OR

ITI XDR Document
Recipient
||
ITI TF-1:10

ITI TF-1:16

ITI TF-1:15
||
|-
|}
''Note 1: Each
actor of APSR SHALL be grouped with at least one of the ITI actors listed in
its table row.''

==10.4 APSR Overview==

===10.4.1 Concepts===

This content profile represents a common
digital document model applicable to any structured report for surgical
pathology in all fields of anatomic pathology (cancers, benign neoplasms, non-neoplastic
conditions) as well as for cytopathology.

This common model is composed of a header conveying
the context of care (patient, care providers, pathologists, laboratories,
order, act documented …) and a body. The body organizes the human-readable
content of the report in a number of sections. Each section may also provide
machine-readable content in a repeatable “entry” embedded in the section. This common model defines the order of
appearance, cardinalities and internal structure of each section, and of each
entry embedded in each section.

Figure 10.4.1-1 shows this general model
applicable to any pathology digital report.

[[Datei:10.4.1-1_FM.jpeg]]

Figure 10.4.1-1
'''Common model for a digital anatomic pathology structured report'''

Note 1: The only section that is mandatory is
the Diagnostic Conclusion section.

=== 10.4.2 Use Cases ===
==== 10.4.2.1 Use case #1: Single Report ====
Anatomic pathology order fulfilled by a pathology laboratory produces a report.

=====10.4.2.1.1 Single Report Use Case Description=====
Dr. Eva Surgeon, PhD, takes a ultrasound guided core biopsy from a breast tumor from patient Eve Onewoman, born on Sept 21 1971, requests the procedure “breast core biopsy specimen - pathological examination” and sends the specimen to the anatomic pathology laboratory of the Cancer Institute.
One specimen (five cores) is accessioned by the anatomic pathology laboratory under the accession number A710240008. The staff performs a macroscopic examination of the specimen; gross imaging is performed if needed. The specimen with the specimen ID A710240008_A is processed for microscopic examination and other special ancillary techniques or tissue banking if needed. During the imaging interpretation process, microscopic imaging is performed if needed. At the end of the interpretation process of the macroscopic and microscopic observations and some ancillary techniques, done by the pathologists Dr. Marcel Pathologist, PhD, and Dr. Jonas Jones, M.D., Dr. Marcel Pathologist queries the Content Creator application for the appropriate APSR template, fills the form, binds some relevant images and/or regions of interest to specific observations, validates and signs the digital report.

=====10.4.2.1.2 Single Report Process Flow=====

Intentionally left blank

=====10.4.2.1.3 Single Report Text Example=====
Macroscopic observation

A. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY):

Microscopic observation

INVASIVE ADENOCARCINOMA OF THE BREAST. 
ICD-O-3-CLASSIFICATION: C50.3 M8500/33 
HISTOLOGIC TYPE: DUCTAL. 
NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3. 
TUBULE FORMATION SCORE: 2.
NUCLEAR PLEOMORPHISM SCORE: 2.
MITOTIC RATE SCORE: 1.

IN-SITU CARCINOMA: EQUIVOCAL.

BREAST CANCER BIOMARKER STUDIES: 
PARAFFIN BLOCK NUMBER: A1. 
ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8, Percentage of positive cells = 85%, Staining Intensity score = 3). 
PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8). 
DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF
EPIDERMAL GROWTH FACTOR RECEPTOR. 
HER2/NEU IMMUNOHISTOCHEMISTRY: AMBIGUOUS(2+) FOR OVEREXPRESSION OF HER2/NEU
ONCOPROTEIN. 
HER2/NEU FISH RESULT: NEGATIVE FOR AMPLIFICATION OF HER2/NEU. 

Diagnostic conclusion

A. "RIGHT BREAST FIVE CORES 8-9:00" (ULTRASOUND GUIDED NEEDLE CORE BIOPSY):

INVASIVE ADENOCARCINOMA OF THE BREAST. 
ICD-O-3-CLASSIFICATION: C50.3 M8500/33 
HISTOLOGIC TYPE: DUCTAL. 
NOTTINGHAM COMBINED HISTOLOGIC GRADE: 1 OF 3. 
TUBULE FORMATION SCORE: 2.
NUCLEAR PLEOMORPHISM SCORE: 2.
MITOTIC RATE SCORE: 1.

IN-SITU CARCINOMA: EQUIVOCAL.

BREAST CANCER BIOMARKER STUDIES: 
PARAFFIN BLOCK NUMBER: A1. 
ER INTERPRETATION: POSITIVE ESTROGEN RECEPTOR ACTIVITY (ALLRED SCORE = 8, Percentage of positive cells = 85%, Staining Intensity score = 3). 
PR INTERPRETATION: POSITIVE PROGESTERONE RECEPTOR ACTIVITY (ALLRED SCORE = 8). 
DAKO EGFR PHARMDX IMMUNOHISTOCHEMISTRY: NEGATIVE (0) FOR EXPRESSION OF
EPIDERMAL GROWTH FACTOR RECEPTOR. 
HER2/NEU IMMUNOHISTOCHEMISTRY: AMBIGUOUS(2+) FOR OVEREXPRESSION OF HER2/NEU
ONCOPROTEIN. 
HER2/NEU FISH RESULT: NEGATIVE FOR AMPLIFICATION OF HER2/NEU. 

====10.4.2.2 Use Case #2: Multi-step Report====

Reporting includes multiple successive steps.

=====10.4.2.2.1 Multi-step Report Use Case Description=====

A surgeon removes a breast tumor from a patient, requests the procedure “breast surgical specimen - frozen sections & pathological examination”, and “breast surgical specimen - pathological examination” and sends the specimen(s) to the anatomic pathology laboratory.

Specimens are accessioned by the anatomic pathology department. The staff performs a macroscopic examination of the specimens, gross imaging is performed if needed. The specimens are processed for intraoperative observation if needed, and tissue banking if needed (e.g., for research purpose). During the imaging interpretation process of frozen sections, microscopic imaging is performed if needed. At the end of the interpretation process, the pathologist queries the Content Creator for the appropriate APSR template, fills the intraoperative observation section, binds some relevant images and/or regions of interest to specific observation(s) if needed, validates and signs (i.e., legally authenticates) the preliminary APSR.

The day after, the specimen(s) are processed for microscopic examination and other special ancillary techniques if needed. During the imaging interpretation process, microscopic imaging is performed if needed. At the end of the interpretation process, pathologist queries the Content Creator for the preliminary APSR, fills the form, binds some relevant images and/or regions of interest to specific observation(s), validates and signs (i.e., legally authenticates) the final APSR.

=====10.4.2.2.2 Multi-step Report Process Flow=====

Intentionally left blank

==10.5 APSR Security Considerations==

See Appendix A of PaLM TF-1.

==10.6 APSR Cross Profile Considerations==

Intentionally left blank

@@ Zeile 313: / Zeile 313: @@
 ONCOPROTEIN.<br/>
 HER2/NEU FISH RESULT: NEGATIVE FOR AMPLIFICATION OF HER2/NEU.<br/>
 ====10.4.2.2 Use Case #2: Multi-step Report====

@@ Zeile 167: / Zeile 167: @@
 OR
-ITI XDR Document
+ITI XDR Document Source
 Source
 ||
 ITI TF-1:10
@@ Zeile 177: / Zeile 180: @@
 ITI TF-1:15
 ||
 |-
@@ Zeile 192: / Zeile 198: @@
 ITI XDR Document
 Recipient
 ||
 ITI TF-1:10
@@ Zeile 202: / Zeile 212: @@
 ITI TF-1:15
 ||
 |-

@@ Zeile 153: / Zeile 153: @@
 '''Table 10.3-1: Anatomic Pathology Structured Report - Required Actor Groupings'''
 {| class="hl7table"
-!XD-LAB Actor !! Actor to be grouped with !! Reference !! Content Bindings Reference
+!APSR Actor !! Actor to be grouped with !! Reference !! Content Bindings Reference
 |-
 |Content
@@ Zeile 208: / Zeile 208: @@
 actor of APSR SHALL be grouped with at least one of the ITI actors listed in
 its table row.''
 ==10.4 APSR Overview==

@@ Zeile 230: / Zeile 230: @@
 applicable to any pathology digital report.
-[[Datei:10.4.1-1_FM.jpeg]]
+[[Datei:10.4.1-1_FMupd.jpeg]]
 Figure 10.4.1-1

cdapath:Vol1Profiles - Versionsgeschichte

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