Latest revision as of 18:53, 7 December 2009

Introduction

This is a draft of the Cancer Registry Pathology Report Content Profile (CRPR) supplement to the PCC Technical Framework. This draft is a work in progress, not the official supplement or profile.

Profile Abstract

The Cancer Registry Pathology Report Content Profile (CRPR) defines the the content used in the PCC-11 to send a completed pathology report to a Cancer Registry using an HL7 Version 2.3.1 ORU message.

Glossary

International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3)

Classification system for reporting incidences of malignant diseases.

NAACCR

The North American Association of Central Cancer Registries. A collaborative umbrella organization for cancer registries, governmental agencies, professional organizations, and private groups in North America interested in enhancing the quality and use of cancer registry data.

Pathology Report

The written description of the microscopic examination of a tissue. The gross description reports the physical characteristics of the tissue: size, color, and abnormalities visible with the unaided eye. The microscopic description reports the cellular characteristics aided by the use of a microscope: what cells are involved, the behavior, and the aggressiveness or grade of any abnormality. The final diagnosis is a summary of the findings and indicates the pathologist’s impression of what was found in concise terms.

Issue Log

Open Issues

Issue: Dependencies: need help understanding this component
- Depends on Care Management with the V2 option (and by reference ATNA and CT)
Issue: Modify Actor/Transactions (Keith)
Issue: Modify Content Module for V2 profiles (Keith)
Issue: Grouping: Does this need to be modified for the CRC profile?
- Yes, not sure how

-->>Register Pathology Implementation Guide with HL7 Message Profile Registry<<--

In Progress

Closed Issues

Issue: Glossary: Use MERP glossary document or consolidated glossary tool?
- Refer to the existing document
Issue: Options: need help understanding this component
- Won't have any
- Added options based on discussion at May f2f meeting.
Issue: Transaction Definitions: need help understanding this component
- Not relevant to this profile
Issue: What information do we need to include in 3.1.2, 3.1.3, 3.2, 3.3, 3.4?
- Just reference the NAACCR Documentation on this section
Should we include a sample message?
- include a link to a webpage of a sample message. There are ways to convert a document to a webpage....

Volume I

Add the following bullet to the list of profiles

The Cancer Registry Pathology Report Content Profile (CPR) defines the the content used in the PCC-11 to send a completed pathology report to a Cancer Registry using an HL7 Version 2.3.1 ORU message.

Dependencies

Add the following row(s) to the list of dependencies

Integration Profile	Dependency	Dependency Type	Purpose
Cancer Registry Pathology Report (CPR)	Care Management (CM)	The Content Creator actor of the CPR profile must be grouped with the Clinical Data Source Actor of the CM profile	The CPR profile defines the content sent in the PCC-11 transaction specified in the CM profile
Cancer Registry Pathology Report (CPR)	Care Management (CM)	The Content Consumer actor of the CPR profile must be grouped with the Care Manager Actor of the CM profile	The CPR profile defines the content recieved in the PCC-11 transaction specified in the CM profile
Cancer Registry Pathology Report (CPR)	ATNA	Actors the CPR profile shall implement the Secure Node Actor of the ATNA profile	Ensures that transmissions and changes to patient health information are logged in an audit repository, and that communication is secured between nodes.
Cancer Registry Pathology Report (CPR)	ATNA	Actors the CPR profile shall implement the Time Client Actor of the CT profile	Ensures that concistent time is used in all messages.

Cancer Registry Pathology Report Content

The Cancer Registry Pathology Report Content Profile (CRPR) defines the the content used in the PCC-11 to send a completed pathology report to a Cancer Registry using an HL7 Version 2.3.1 ORU message.

Monitoring the occurence of cancer is a cornerstone of cancer control decision making. this monitoring, referred to as cancer surveillance, can be used to trigger case investigations, follow trends, evaluate the effectiveness of prevention measures such as screening and early detection programs and suggest public health priorities. It is vital to identify and registrar all cancer cases. By not identifying all of the cancer cases, cancer incidence will be underestimated, giving a false impression of the magnitude of the cancer problem in the registry’s population area. Inaccurate incidence rates can misdirect cancer control efforts, and provide a false picture of the effectiveness of treatment efforts.

Because most cancers are definitively diagnosed by microscopic examination of tissue, cancer surveillance programs rely on pathology reports to identify new cases and collect further information on cases previously reported.

Two challenges relate to pathology laboratory reporting of cancer cases. Laboratories may photocopy selected pathology reports and mail them to the cancer registry. This method is labor intensive and prone to missing cases because the laboratory staff is not aware of the full case definition for identifying a cancer case. Additionally, the cancer registry staff must re-enter the information into the cancer registry with a risk of data entry errors.

Alternately, laboratories may choose not to actively report cases, but allow cancer registry personnel to identify and photocopy appropriate pathology reports on site. This is very costly for the registry and has the same risk of data entry errors when the reports are manually entered into the registry database.

Further information on the benefits, challenges and the cancer registry's uses of electronic pathology reporting can be found in the:

[4] : North American Association of Central Cancer Registries (NAACCR) Electronic Pathology (E-Path) Reporting Guidelines, Dec 2006.

Use Cases

Pre-condition

A woman goes in for a routine mammogram and a suspicious area is noted. The woman is referred by her family physician to a surgeon who does a biopsy and sends the tissue sample to the pathology laboratory for review and diagnosis.

The pathology laboratory receives the specimen, logs it into the laboratory information system (LIS) and prepares the specimen for analysis. The pathologist analyzes the specimen and dictates his/her findings, which are then transcribed into the LIS. The pathologist verifies the accuracy of the report and signs the transcribed report. The LIS marks the pathology report as "Final", triggering the use case events.

Events
1. Pathology Laboratory Creates Message

The LIS identifies that the report matches submission criteria because it is a histopathology test (biopsy) and the diagnosis relates to cancer ("carcinoma"). The LIS gathers information from its database and other appropriate databases to create a message that contains all of the required data elements. The LIS validates the data to ensure it conforms to the HL7 2.3.1 ORU-RO1 specification and transmits it to the Cancer Registry using a secure connection.

Pathology Laboratory Process Flow
: [1] : North American Association of Central Cancer Registries (NAACCR) Electronic Pathology (E-Path) Reporting Guidelines, Dec 2006.

1. Cancer Registry Processes Registration

The Cancer Registry receives the HL7 messages, parses it into the processing database and determines that a cancer diagnosis has been documented. The Cancer Registry staff codes the medical information. The pathology data and coded information is exported to the Cancer Registry Database and the message is archived.

Cancer Registry Process Flow
: [2] : North American Association of Central Cancer Registries (NAACCR) Electronic Pathology (E-Path) Reporting Guidelines, Dec 2006.

Post-condition

Pathology information has been added to the Cancer Registry Database.
The message is available for future use as needed.

Scope

The following diagram constrains the scope of the Cancer Registry Pathology Report Content Profile.

Cancer Registry Pathology Report Content Profile Scope of Action Diagram
: [3] : North American Association of Central Cancer Registries (NAACCR) Electronic Pathology (E-Path) Reporting Guidelines, Dec 2006.

Actors/Transaction

There are two actors in this profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile.

Cancer Registry Pathology Report Content Actor Diagram

Grouping

Care Management (CM)

The Content Creator of this profile must be grouped with the Clinical Data Source of the Care Management profile. The Clinical Data Source actor must implement the V2 Care Management Update Option.

The Content Consumer Actor of this profile must be grouped with the Care Manager actor of the Care Management profile.

Basic Patient Privacy Consents (BCCP)

When patient consent is required (for example, as in the case of Quebec), the Content Creator may be grouped with the Content Consumer Actor of the BPPC profile. When grouped with that actor, the Content Creator shall verify that an appropriate consent has been registered for the patient to share the pathology data prior to sending the message.

Policy Considerations

Batch or Real Time Reporting

Because the Cancer Registry Pathology Report Content Profile relates to secondary use of data, Batch Reporting with a frequency of every 24 hours is recommended.

Case Selection

A Content Consumer may require that all reports be transmitted, regardless of relevance to cancer, or it may require transmission to be restricted based on specific selection criteria. This is a policy decision made by the Content Receiver based on state, provincial and fedreal legislations and/or regulations, rules or by operating policy.

Security Considerations

Requirements/Capabilities

Case selection

Provide option to select all reports or only those that meet selection criteria. Refer to Volume II for:

List of anatomic pathology reports
Standards for Identifying Pathology Reports
List of Cancer Medicine Elisa kit

Message Conformance

Message can be validated using:

[5] : NAACCR Volume V Messaging Workbench Profile.

@@ Line 9: / Line 9: @@
 ==Glossary==
-Refer to the Glossary posted on CDC's National Program of Cancer Registries Modeling Electronic Reporting Project website:  www.cdc.gov/cancer/npcr/informatics/merp/TBD
+;International Classification of Diseases for Oncology, 3rd Edition (ICD-O-3)<br>
+Classification system for reporting incidences of malignant diseases.
+;NAACCR
+The North American Association of Central Cancer Registries. A collaborative umbrella organization for cancer registries, governmental agencies, professional organizations, and private groups in North America interested in enhancing the quality and use of cancer registry data.
+;Pathology Report <br>
+The written description of the microscopic examination of a tissue.  The gross description reports the physical characteristics of the tissue:  size, color, and abnormalities visible with the unaided eye.  The microscopic description reports the cellular characteristics aided by the use of a microscope:  what cells are involved, the behavior, and the aggressiveness or grade of any abnormality.  The final diagnosis is a summary of the findings and indicates the pathologist’s impression of what was found in concise terms.
 ==Issue Log==
@@ Line 20: / Line 27: @@
 # Issue: Grouping:  Does this need to be modified for the CRC profile?
 #* Yes, not sure how
-# What should go under Header Template 1?
-# What should go under Entry Template 1?
-#  KEITH -  PLEASE CHANGE TITLE TO:  Cancer Registry Pathology Report
 {{Fixme|Register Pathology Implementation Guide with HL7 Message Profile Registry}}
@@ Line 44: / Line 46: @@
 =Volume I=
 <pre>Add the following bullet to the list of profiles</pre>
-* The Cancer Registry Content Profile (CRC) defines the the content used in the {{ILink|Cancer Registry Content|PCC-11}} to send a completed pathology report to a Cancer Registry using an HL7 Version 2.3.1 ORU message.
+* The Cancer Registry Pathology Report Content Profile (CPR) defines the the content used in the {{ILink|Cancer Registry Content|PCC-11}} to send a completed pathology report to a Cancer Registry using an HL7 Version 2.3.1 ORU message.
 ===Dependencies===
 <pre>Add the following row(s) to the list of dependencies</pre>
-{|style='background-color:#7f7f7f;' align='center' border='1' cellspacing='0'
+{{T|Integration Profile|Dependency|Dependency Type|Purpose|Rows=
-!Integration Profile
+{{R|Cancer Registry Pathology Report (CPR)|Care Management (CM)|The Content Creator actor of the CPR profile must be grouped with the Clinical Data Source Actor of the CM profile|The CPR profile defines the content sent in the PCC-11 transaction specified in the CM profile}}
-!Dependency
+{{R|Cancer Registry Pathology Report (CPR)|Care Management (CM)|The Content Consumer actor of the CPR profile must be grouped with the Care Manager Actor of the CM profile|The CPR profile defines the content recieved in the PCC-11 transaction specified in the CM profile}}
-!Dependency Type
+{{R|Cancer Registry Pathology Report (CPR)|ATNA|Actors the CPR profile shall implement the Secure Node Actor of the ATNA profile|Ensures that transmissions and changes to patient health information are logged in an audit repository, and that communication is secured between nodes.}}
-!Purpose
+{{R|Cancer Registry Pathology Report (CPR)|ATNA|Actors the CPR profile shall implement the Time Client Actor of the CT profile|Ensures that concistent time is used in all messages.}}
-|- style='background-color:#ffffff;' align='center'
+}}
-|Cancer Registry Pathology Report Content
-|Care Management
-ATNA
-CT
-|
-|
-|-
-|}
 ==Cancer Registry Pathology Report Content ==
 The Cancer Registry Pathology Report Content Profile (CRPR) defines the the content used in the {{ILink|Cancer Registry Content|PCC-11}} to send a completed pathology report to a Cancer Registry using an HL7 Version 2.3.1 ORU message.
@@ Line 111: / Line 103: @@
 ===Actors/Transaction===
 There are two actors in this profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the appropriate use of IHE profiles described below, and is out of scope of this profile.
-{{Fixme|Update the following to deal with CM and RFD}}
-A [[Document Source]] or a [[Portable Media Creator]] may embody the [[Content Creator]] Actor. A [[Document Consumer]], a [[Document Recipient]] or a [[Portable Media Importer]] may embody the [[Content Consumer]] Actor.
-The sharing or transmission of content or updates from one actor to the other is addressed by the use of appropriate IHE profiles described by section 3.7 Content Bindings with XDS, XDM and XDR found in the [[Frameworks#IHE_Patient_Care_Coordination_Technical_Framework|Patient Care Coordination Technical Framework]]
 [[image:cccc.png|frame|center|Cancer Registry Pathology Report Content Actor Diagram]]
-=== Options ===
 === Grouping ===
-==== Basic Patient Privacy Consents (BCCP) ====
+==== Care Management (CM) ====
-When patient consent is required, the Content Creator may be grouped with the Content Consumer Actor of the BPPC profile.  When grouped with that actor, the Content Creator shall verify that an appropriate consent has been registered for the patient to share the pathology data prior to sending the message.
+The [[Content Creator]] of this profile must be grouped with the [[Clinical Data Source]] of the Care Management profile.  The Clinical Data Source actor must implement the V2 Care Management Update Option.
-==== Patient Demographic Query ====
+The [[Content Consumer]] Actor of this profile must be grouped with the [[Care Manager]] actor of the Care Management profile.
-==== Patient Identity Cross Referencing ====
-=== Content Modules ===
+==== Basic Patient Privacy Consents (BCCP) ====
-Content modules describe the content of a payload found in an IHE transaction. Content profiles are transaction neutral. They do not have dependencies upon the transaction that they appear in.
+When patient consent is required (for example, as in the case of Quebec), the Content Creator may be grouped with the Content Consumer Actor of the BPPC profile.  When grouped with that actor, the Content Creator shall verify that an appropriate consent has been registered for the patient to share the pathology data prior to sending the message.
-{{Fixme| Keith to modify}}
-==== Content Module 1
-{{Fixme|Keith to modify}}
-=== Process Flow ===
-:Not relevant for this Content Profile
-== Actor Definitions ==
-; Actor :
-The Content Creator is played by the Laboratory Information System.
-The Content Consumer is played by the Cancer Registry Software System.
 == Policy Considerations ==
@@ Line 154: / Line 122: @@
 A Content Consumer may require that all reports be transmitted, regardless of relevance to cancer, or it may require transmission to be restricted based on specific selection criteria.  This is a policy decision made by the Content Receiver based on state, provincial and fedreal legislations and/or regulations, rules or by operating policy.
-== Security Considerations? ==
+== Security Considerations ==
-== Transaction Definitions ==
-; Transaction
-: Not relevant for this Content Profile
 == Requirements/Capabilities ==
@@ Line 165: / Line 129: @@
 * List of anatomic pathology reports
 * Standards for Identifying Pathology Reports
+* List of Cancer Medicine [http://www.rapidtest.com/products-elisakits.html Elisa kit]
 ; Message Conformance
-Message conforms to the ________________  using the Messaging Workbench.
+Message can be validated using: <br>
+: [http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=501] : NAACCR Volume V Messaging Workbench Profile.
-{{Fixme|Need to edit the sentence for accuracy.  Also need to provide a current link.  When it becomes official in HL7, need to add that reference.}}
-=Volume II=
-{{Fixme|Give an example of how the notification and query messages need to look to implement this content profile}}
-===Cancer Registry Pathology Report Content ===
-LOINC Tests Affected<br>
-anatomic pathology reports:<br>
-:* histopathology
-:* flow cytometry
-:* cytology
-:* autopsy
-:* bone marrow
-:* peripheral smear
-==== Standards ====
-;Content
-: [http://www.naaccr.org/filesystem/pdf/Standards%20Volume%20V%20version%202.1_draftB_revised%20Jan%202008_B.pdf] :  North American Association of Central Cancer Registries Standards for Cancer Registries Volume V:  Pathology Laboratory Electronic Reporting; Version 2.1
-;Message Specification
-:  HL7 2.3.1  ORU - Unsolicited Observation Message (event RO1)
-{{Fixme|Add sample message:  We have an HTM version but it is not an acceptable version...please advise}}
-; Standards for Identifying Pathology Reports
-: [http://www.naaccr.org/index.asp?Col_SectionKey=7&Col_ContentID=139] : NAACCR Search Term List
-; Case Definition
-: [http://www.naaccr.org/filesystem/pdf/Vol_II_draft_board%20-%20Fix%20Pg%2098.pdf] : Chapter III.  Standards for Tumor Inclusion and Reportability. NAACCR Standards for Cancer Registries Volume II:  Data Standards and Data Dictionary. Twelfth Edition; Record Layout Version 11.2.
-; Coding of Medical Information;
-: World Health Organization : International Classification of Diseases for Oncology (ICD-0) Third Edition
-==== Data Element Index ====
-: [http://www.naaccr.org/filesystem/pdf/Standards%20Volume%20V%20version%202.1_draftB_revised%20Jan%202008_B.pdf] : Refer to NAACCR Standards for Cancer Registries Volume V:  Pathology Laboratory Electronic Reporting Verison 2.1, Chapter 2.6
-==== Message Specification ====
-Refer to NAACCR Standards for Cancer Registries Volume V:  Pathology Laboratory Electronic Reporting Verison 2.1, Chapter 2.6
-==== HL7 Example of a Pathology Report HL7 Message to a Cancer Registry ====
-{{Note|Lines in the example below have been wrapped to support display of the example.}}
-<pre>
-MSH|^~\&|TESTLAB1|INDEPENDENT LAB SERVICES^LABCLIANUM^CLIA|||200404281339||ORU^R01|2004042813390045|P|2.3.1|||||||||2.0
-PID|1||123456789^^^^SS|000039^^^^LR|McMuffin^Candy^^^Ms.||19570706|F||2106-3
-  |495 East Overshoot Drive^^Delmar^NY^12054||^^^^^518^5559999|||M|||4442331235
-ORC|RE||||||||||||||||||||General Hospital^^123456^^^AHA|857 Facility Lane^^Albany^NY^12205
-  |^^^^^518^3334444|100 Provider St^^Albany^NY^12205
-OBR|1||S91-1700|22049-1^cancer identification battery^LN|||20040720|||||||
-  |^left breast mass|1234567^Myeolmus^John^^MD|(518)424-4243||||||||F|||||||99999&Glance&Justin&A&MD
-OBX|1|TX|22636-5^clinical history^LN||47-year old white female with (L) UOQ breast mass||||||F|||20040720
-OBX|2|ST|22633-2^nature of specimen^LN|1|left breast biopsy||||||F|||20040720
-OBX|3|ST|22633-2^nature of specimen^LN|2|apical axillary tissue||||||F|||20040720
-OBX|4|ST|22633-2^nature of specimen^LN|3|contents of left radical mastectomy||||||F|||20040720
-OBX|5|TX|22634-0^gross pathology^LN|1|Part #1 is labeled "left breast biopsy" and is received fresh after frozen section
-  preparation. It consists of a single firm nodule measuring 3cm in circular diameter and 1.5cm in thickness surrounded by
-  adherent fibrofatty tissue. On section a pale gray, slightly mottled appearance is revealed. Numerous sections are submitted
-  for permanent processing.||||||F|||20040720
-OBX|6|TX|22634-0^gross pathology^LN|2|Part #2 is labeled "apical left axillary tissue" and is received fresh. It consists of
-  two amorphous fibrofatty tissue masses without grossly discernible lymph nodes therein. Both pieces are rendered into
-  numerous sections and submitted in their entirety for history.||||||F|||20040720
-OBX|7|TX|22634-0^gross pathology^LN|3|Part #3 is labeled "contents of left radical mastectomy" and is received flesh. It
-  consists of a large ellipse of skin overlying breast tissue, the ellipse measuring 20cm in length and 14 cm in height. A
-  freshly sutured incision extends 3cm directly lateral from the areola, corresponding to the closure for removal of part #1.
-  Abundant amounts of fibrofatty connective tissue surround the entire beast and the deep aspect includes and 8cm length of
-  pectoralis minor and a generous mass of overlying pectoralis major muscle. Incision from the deepest aspect of the specimen
-  beneath the tumor mass reveals tumor extension gross to within 0.5cm of muscle. Sections are submitted according to the
-  following code: DE- deep surgical resection margins; SU, LA, INF, ME -- full thickness radila samplings from the center of
-  the tumor superiorly, laterally, inferiorly and medially, respectively: NI- nipple and subjacent tissue. Lymph nodes
-  dissected free from axillary fibrofatty tissue from levels I, II, and III will be labeled accordingly.||||||F|||20040720
-OBX|8|TX|22635-7^microscopic pathology^LN|1|Sections of part #1 confirm frozen section diagnosis of infiltrating duct
-  carcinoma. It is to be noted that the tumor cells show considerable pleomorphism, and mitotic figures are frequent (as many
-  as 4 per high power field). Many foci of calcification are present within the tumor. ||||||F|||20040720
-OBX|9|TX|22635-7^microscopic pathology^LN|2|Part #2 consists of fibrofatty tissue and single tiny lymph node free of disease.
-  ||||||F|||20040720
-OBX|10|TX|22635-7^microscopic pathology^LN|3|Part #3 includes 18 lymph nodes, three from Level III, two from Level II and
-  thirteen from Level I. All lymph nodes are free of disease with the exception of one Level I lymph node, which contains
-  several masses of metastatic carcinoma.  All sections taken radially from the superficial center of the resection site fail
-  to include tumor, indicating the tumor to have originated deep within the breast parenchyma. Similarly, there is no
-  malignancy in the nipple region, or in the lactiferous sinuses.  Sections of deep surgical margin demonstrate diffuse tumor
-  infiltration of deep fatty tissues, however, there is no invasion of muscle. Total size of primary tumor is estimated to be
-cm in greatest dimension.||||||F|||20040720
-OBX|11|TX|22637-3^final diagnosis^LN|1|1. Infiltrating duct carcinoma, left breast. ||||||F|||20040720
-OBX|12|TX|22637-3^final diagnosis^LN|2|2. Lymph node, no pathologic diagnosis, left axilla.||||||F|||20040720
-OBX|13|TX|22637-3^final diagnosis^LN|3|3. Ext. of tumor into deep fatty tissue. Metastatic carcinoma, left axillary lymph
-  node (1) Level I. Free of disease 17 of 18 lymph nodes - Level I (12), Level II (2) and Level III (3). ||||||F|||20040720
-OBX|14|TX|22638-1^comments^LN||Clinical diagnosis: carcinoma of breast. Post-operative diagnosis: same.||||||F|||20040720
-</pre>

Difference between revisions of "Cancer Registry Pathology Report"