IG:HL7 diagnosis

Introduction

Introduction

Documentation of diagnoses is an essential part of many workflows in healthcare systems.

The ways of documenting a diagnosis may depend on the purpose such as medical, statistical, research-related, legal or administrative purposes.

This guideline focusses on the structured electronic documentation of diagnoses for the following applications:

Germany

Fields of application for diagnosis documentation in Germany are e.g.

• Capturing a diagnosis for the purpose of billing an ICD-10-GM code under Federal German Code SGB V
  • under law §301 for in-patients
  • under law §295 for out-patients /ambulatory care
  • under law §140 for integrated care plans ("IGV-MVZ")
• Cause-of-death statistics based on ICD-10 WHO
• Quality assurance as of law §137 SGB V and related hospital quality reports
• Infectious disease reporting as required under Infektionsschutz-Gesetz
• Epidemiology and cancer registers (using ICD-O), including further classification of tumor diseases (1)
• Expertise by payor for the purpose of retirement plans and statutory insurances (using e.g. ICF)
• Medical documentation in healthcare such as referral letters, admission letters, sick-leave-notes, prescriptions, in-patient EHRs
• Clinical studies (MedDRA, WHO-Art)
• Payor Risk Compensation as of "Risikostrukturausgleich" ruling
• Product detail information for medication, such as indications, counter-indications amd sideeffects ("UAW")

Administrative documentation of diagnoses will be required for justifying the billing of therapy such as treatment/procedures.

Since Jan 1st 2000 the classification ICD-10 GM as mandatory for diagnosis encoding in both ambulatory and in-patient care, especially for lump sum billing as ruled under G-DRG (German Diagnosis Related Groups).

Primary care data and routine care data may not just be used for billing but also for further purposes. Only standardized guidelines support multiple use of such data.

Statistical processing of diagnostic data may e.g. be used for quality assurance and for research, with diagnoses typically being encoded using classifications, like ICD-10, but also ICD-O and ICF.

For future integrated applications which process structured electronic diagnoses to support medical decision-making processes, advanced terminologies may have to be used, like e.g. the alphabetical index into ICD and medication/substance directories.

Note 1 TNM- and the UICC-System proved to be insufficient for grading tumors of the central nervous systems because of their low metastasis and the weak relationship between tumor size and its aggressiveness. [Louis 2007]. Therefore we will apply the WHO-Grading (see 6.8)

Scope

Scope of this document is an elementary specification of how to represent diagnoses using HL7 V3 messages and documents.

Diagnoses exactly map from symptoms (diagnostic signs) to terms for diseases.

A a principle HL7 represents diagnoses as observations made by a doctor at a patient, which means that diagnostic data will be modelled using the HL7 Observation class, independent of the V3 model being used.

The goal is to have a model-independent specifiation of how to map relevant diagnostic data into the class Observation.

This document is based on using a structured diagnosis.

Chapter 3 explains attributes of diagnostic data Chapter 4 explains the use of the Observation class Chapter 5 focusses on the representation of encoded diagnoses, with section 5.1 mentioning specialties of ICD-10 encding especially in the context of German requirements Chapter 6 specifies the representation of diagnoses in tumor documentation. Chapter 7 includes examples representations of diagnosis from vrious fields of application.

Diagnosis Types

Clarification

In HL7 Version 3 the term classification of diagnoses means the type or kind of diagnosis, like e.g. "Admission Diagnosis" or "Referral Diagnosis". For clarity, we will use the term "type of diagnosis" in the following text.

Types of Diagnoses in Ambulatory Care

Germany

The federal association (KBV) of regional statutory billing associations (KV) for out-patient/ambulatory care in Germany published the so-called KVDT data set as the mandatory format for billing. It combines billing data (ADT, not to be confused with the HL7 ADT data), the rehab billing data (KADT) and the statistical data (STDT) of a GPO reporting to its assigned (regional) KV. Part of the KVDT data set is a diagnosis specification with the following types of diagnosis

Billing Diagnosis - current diagnosis being the basis for billing Continued Diagnosis - diagnoses that are valid for more than three quarters (of a year).

Despite these billing diagnoses it is also allowed to send continued diagnoses (more than one quarter) which are related to the services billed. Using the record attribute 6001 ("ICD-10-code") for continued diagnoses is not permitted, instead the attribute 3673 ("continued diagnosis") shall store the ICD-10-code, combined with attribute 3674 ("confidence - continued diagnosis") and optionally the attributes 3675("side localization - continued diagnosis") or , attribute 3676 ("explanation - continued diagnosis") may be used. Either attributes 6001 or 3673 shall be used.

Types of Diagnoses for Inpatient Care

Deutschland

The (Federal German Code SGB V) billing law § 301 SGB V states the diagnosis specifications which shall be sent by hospitals to payors. Based on that law, the data transfer guidance „Datenuebermittlung nach §301“ of the federal hospital association DKG has been published. This guidance defines different record types (e.g. admission record, discharge record) which also include diagnosis specifications, as given by the following table:

Record type	Segment: Name	Diagnosis
Admission Record	EAD	Admission Diagnosis
Indicator for Continuation	DAU	Continued Diagnosis - justiyfing sick leave
Indicator for Continuation	FAB	Diagnosis by specialized clinical department
Discharge Record	DAU	Continued Diagnosis - justiyfing sick leave
Discharge Record	ETL	Discharge Diagnosis
Discharge Record	NDG	Concurrent Diagnosis
Discharge Record	FAB	Diagnosis by specialized clinical department
Outpatient Procedure	RZA	Referral diagnosis
Outpatient Procedure	BDG	Treatment diagnosis

As a result this guidance distinguishes the following types of diagnoses under §301 SGB V:

• Admission Diagnosis
• Inpatient Admission Diagnosis
• Special Department Diagnosis
• Continued Diagnosis (with sick leave)
• Discharge Diagnosis
• Special Department Diagnosis Extension
• Referral Diagnosis
• Treatment Diagnosis

Main diagnoses and concurrent diagnoses (as defined by medical aspects) as well as primary and secondary diagnoses shall be represented via additional attributes.

Regarding further diagnosis types please see Annex A

Common Diagnosis Descriptions

Introduction

This chapter gives the attributes that are common parts of a structured diagnosis specification which are required for processing an electronic diagnosis information.

Plain-Text Description

This attribute describes the diagnosis through prosaic text, hate.g. may be entered via a text entry field by the medical professional. This plain text description should be a mandatory part of medical documentation.

Example: Allergic asthma

Note that plain-text descriptions will not necessarily match the associated text of diagnosis codes, like the ones from the systematic classification ICD-10.

Diagnosis Code

For the purposes of administrative and statistical processing, diagnoses are being encoded by encoding systems. E.g. ICD-10 is mandatory under billing according to (Federal German Code) SGB V §391 and §295.

Further systematic encoding systems are e.g. „Alpha-ID“, SNOMED CT and ID MACS.

Example: J45.0

Diagnosis Code – Catalog Text

The catalog text is the associated text for a given diagnosis code. It does not have to match the plain text and can be rendered by an automated system - based on a given diagnosis code.

Example: Predominantly allergic asthma

Diagnosis Type

The diagnosis type further specifies the type of a diagnosis and will be given in an encoded form. Examples may be "referral diagnosis", "admission diagnosis", "discharge diagnosis" etc.

Diagnosis Date

This attribute describes date and time when a medical professional made the given diagnosis.

Documentation Date

This attribute describes date and time when the diagnosis was documented.

Note that when there is no need to distinguish both dates, the diagnosis date shall be used.

Specification of the Clinically-Relevant Time of a Diagnosis

This attribute is a time interval specified by a start time and end time information giving the time in which the patient suffered from the specified disease.

Giving only a start date documents the time since when the patient had that diagnosis.

The start date may be different from the diagnosis date.

Date information in diagnoses may be with different precision.

Examples: Diabetes since 2006 or Fracture of Femur on March 12th, 2007

Diagnosis Confidence

This attribute describes the confidence of the specific diagnosis.

For billing under ambulatory/out-patient care (under Federal German Code SGB V) defined attributes (suffices A, G, V or Z) are compulsory while such attributes are not allowed for in-patient billing (under Federal German Code SGB V).

Localization

The localization attribute specifies in which body site (topography) the disease was diagnosed.

Both plain text or encoded terms are allowed.

An example is the ICD-O site code for tumor documentation.

As a suffix the side may be used.

Explanations

This attribute allows medical professionals to document detailed explanations using a plain text.

Reasons for Exceptions

This plain-attribute may be required to justify a diagnosis e.g. in the context of billing.

Diagnosis Model in HL7 V3

Summary

Diagnoses represented in HL7 V3 shall useu the class Observation, which is modelled as shown in fig. 1.

Detailed descriptions of classes and data types in this model can be found in the related HL7 V3 documentation and Data Type Guidelines.

The following sections specifiy how diagnosis attributes shall be mapped into the Observation model.

Plain Text

value.originalText diagnosis as a plain text ST[0..1] Plain text descriptions of the specific diagnosis shall be stored in the subelement originalText of element value. If it is not necessary to specify a text or should this text not be available, the @nullFlavour attribute shall be used. This element shall explain the reason why there is no plain text. A value of "NAV" states that no coded text is available (yet). More values are described in the HL7 documentation.

The attribute @language of subelement originalText may be used to specify the language of the prosaic diagnosis text.

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <value xsi:type="CD" nullFlavor="NAV">
      <originalText>Rektumkarzinom mit Höhenlokalisation ab Anokutanlinie/Linea dentata
      </originalText>
    </value>
  </observation>

Diagnosis Code and Text

value Diagnosis Code CD[0..1] Representing a diagnosis via a code and its associated text shall be done va the value element (in the model: an attribute of the Observation class).

The XML attribute @code shall store the diagnosis code and @displayname shal store the associated diagnosis text.

Such a structured representation of e.g. an ICD10 coded diagnosis looks like this:

The XML attribute @codeSystem shall store the OID for the specific ICD-10-GM version being used and the @codeSystemName attribute shall store the plain text name of the coding system and version.

  <!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
  ...
    <!-- ICD-Code of a diagnosis -->
    <value xsi:type="CD" code="I01.0"
      displayName="Akute rheumatische Perikarditis"
      codeSystem="1.2.276.0.76.5.311" codeSystemName="icd10gm2006"/>
    ...
  </observation>

Diagnosis Type

code classification code CD CW[1..1] The XML attribute shall specifiy the classification code using the attribute @codeSystem for storing the OID of that coding system (also see Annex <10>)

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
     <code code="DX" codeSystem="1.2.276.0.76.5.342"/>
     ...
  </observation>

Diagnosis Date

author.time Diagnosis Date IVL<TS>[0..1] The diagnsis date shall specify when the diagnosis was made as the time in the clinical process which is not necessarily the documentation date. The diagnosis date shall be represented using the author instance which shall be connected via Participation to the current Observation instance. Instances of author contain a model attribute time of type IVL<TS>. Detailed information regarding the person giving the diagnosis shall be modelled using an instance of assignedEntity.

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <author>
      <!-- Diagnosedatum -->
      <time value="20100111"/>
      <assignedAuthor>
        ...
      </assignedAuthor>
    </author>
    ...
  </observation>

Documentation Date

dataEnterer.time documentation date TS [1..1]

The documentation is the date when the diagnosis has been entered by e.g. a clinician. The data value is mapped to an instance dataEnterer which is related via a Particpation to the Observation instance (see fig. 1 Observation Model).

The dataEnterer class has an model attribute time of type TS, such that in XML the data value will be mapped into an element time and an XML attribute @value.

In case there is no dataEnterer instance, the participation relation with its model attribute typeCode=ENT also manages a participationRole instance representing the data entering person that would otherwise be modelled through a instance of dataEnterer.

<!-- structured representation of diagnosis -->
  <observation classCode="OBS" moodCode="EVN" negationInd="true">
  ...
  <!-- documentation date -->
    <participant typeCode="ENT">
      <time value="20060606"/>
      <participantRole>
        ...
      </participantRole>
    </participant>
    ...
  </observation>

Diagnosis Time Interval

effectiveTime diagnosis time interval IVL<TS>[0..1]

The model attribute effectiveTime of class Observation specifies the time interval for which the specified is (or, has been) clinically relevant.

In XML, the sub-element low shall specify the begin data and sub-element high shall specifiy the end date. Dates for low or high may also be specified without the other.

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <effectiveTime>
       <low value="20050127"/>
    </effectiveTime>
    ...
    </observation>

Diagnosis Confidence

value.qualifier diagnosis confidence CR [0..1]

the diagnosis confidence shall be represented in the model attribute value using a sub-element qualifier.

   <!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <value xsi:type="CD" nullFlavor="NI">
      <originalText>......</originalText>
      <!--diagnosis confidence -->
      <qualifier>
        <name code="8" codeSystem="2.16.840.1.113883.3.7.1.0"/>
        <value code="G" codeSystem="2.16.840.1.113883.3.7.1.8"/>
      </qualifier>
    </value>
  </observation>

XML attribut @code in name shall specify the name of the diagnosis confidence qualifier, based on the table given below. XML attribut @codeSystem shall specify the OID of the system giving these qualifier names. The diagnosis confidence shall be specified using XML attribute @code in the XML element value.

For out-patient care (§ 295 SGB V, Germany) diagnosis confidence attributes are mandatory, while for in-patient care (§ 301 SGB V) they are forbidden i.e. must not be specified. (Source: DIMDI)

Code as of §295 SGB V	Implementation	Meaning	Explanation
G		certain	diagnosis validated
V	uncertaintyCode=UN	suspicious	suspicion diagnosis
Z		state after	an earlier diagnosis is related
A	negationInd=true	excluded	this diagnosis has been excluded (use negationInd in Level 3)

Table 2: Vocabulary Domain for Confidence/Reliability Codesystem: Sciphox (OID: 2.16.840.1.113883.3.7.1.8)

In tumor documentation the validation of diagnosis is also documented by specifying the 8superior) way of diagnosis. This information shall also be specified through the qualifier:

Code	Implementation	Meaning	Explanation
k		clinically
z		zytologically
h		histologically
a		autoptically
d		DCO	Death certificate only.
	nullFlavor = OTH	Other
	nullFlavor = NI	unknown

Table 3: Vocabulary Domain for Diagnosis procedure in tumor documentation Codesystem: (OID: 1.2.276.0.76.5.418)

Localization

targetSiteCode Lokalisation CD CWE [0..1]

Localization of diagnoses shall be specified using the model attribute targetSiteCode. For localizations given as plain text the sub-element originalText of targetSiteCode shall be used. In case no localization code is available, the XML attribute @nullFlavor shall be specified.

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <targetSiteCode nullFlavor="NI">
      <originalText>Oberhalb des rechten Knöchels</originalText>
    </targetSiteCode>
    ...
  </observation>

If a structured code is available, then model attribute targetSiteCode shall have a code sub-element with the code being specified in XML attribute @code and the coding system being specified using XML attribute @codeSystem.

Optionally the XML attribute @displayName may be used to specifiy a plain text for the code and @codeSystemName may be used for the name of the coding system.

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <targetSiteCode code="299058009" codeSystem="2.16.840.1.113883.6.96"
    codeSystemName="SNOMED CT" displayName="kleiner Finger">
      <qualifier>
        <name code="78615007" codeSystem="2.16.840.1.113883.6.96"
              codeSystemName="SNOMED CT" displayName="mit Seitenlokalisation"/>
        <value code="24028007" codeSystem="2.16.840.1.113883.6.96"
               codeSystemName="SNOMED CT" displayName="rechts"/>
      </qualifier>
    </targetSiteCode>
    ...
  </observation>

Note: The localization codes suggested by the German health Ministry (BMG) shall only be used together with diagnoses encoded in ICD 10 (German).

Additional codes for the side localization may be used in out-patient care as well as in-patient care(see 4).

In tumor documentation further codes shall be use for the side localization:

Code	Implementation	Meaning	Explanation	Common Diagnoses	Tumor Diagnoses
R		Right	side localization right	X	X
L		Left	side localization left	X	X
B		both side	diagnosed on both sides	X	X
M		middle line	middle line zone - 1 inch left or right from middle line		X
	nullFlavor = NA	system disease	in the sense of 'not applicable'		X
	nullFlavor = UNK	unknown		X	X

Table 4: Vocabulary Domain for Localization Coding System: (OID: 1.2.276.0.76.5.412)

4 DIMDI 5 Literatur: Basisdokumentation für Tumorkranke 5. Auflage 1999; Dudeck et al

The side localization is used for diagnosis documentation for common and also for tumor documentation, but with differeent value sets, which are defined as follows:

Value Set	Explanation	OID
Common, based on ICD-10	2.16.840.1.113883.3.7.1.7
Tumor Documentation	1.2.276.0.76.11.10

Table 5: Value Sets for Localization

Explanations

text explanation of diagnosis ST [0..1]

Any explaining text shall be represented using the XML attribute text.

A structured representation will look like this:

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    <value xsi:type="CD" code="J45.0" codeSystem="1.2.276.0.76.5.311"
      displayName="Vorwiegend allergisches Asthma bronchiale">
      <originalText>Allergisches Asthma</originalText>
    </value>
    <text>Intermittierend, seit der Jugend</text>
  </observation>

Reasons for Exceptions

value Reasons for Exceptions ST [0..1]

Billling-related exceptions shall be encoded using the @value attribute of an extra Observation instance being related via an ActRelation-Ship instance to the original describing instance of Observation.

A structured representation will look like this:

<!-- structured representation of diagnosis -->
  <observation moodCode="EVN" classCode="OBS">
    ...
    <!-- reason for exception-->
      <entryRelationship typeCode="RSON">
        <observation moodCode="EVN" classCode="OBS">
          <code nullFlavor="UNK"/>
          <value xsi:type="ED">...........</value>
        </observation>
      </entryRelationship>
    ...
  </observation>

XML attribute @typeCode shall have the value RSON (= reason) specifying an exception for billing purposes.

Using more Attributes of Observation

This section describes more model attributes of Observation that may play a role in describing diagnoses.

Attribute 'id'

id diagnosis identificator SET <II>[0..1]

The model attribute id should be used to identify the instance of a diagnosis - which is recommended for computer-based processing of diagnoses in order to refer to the clinical specification of that diagnosis.

In XML representations the XML attribute @extension shall store the diagnosis identifier while the XML attribute @root should specify the OID of the diagnosis database.

In case changes or deletions have to be communicated for this diagnosis instance, this id will provide reference.

Attribute 'classCode'

@classCode classCode <= OBS XML attribute shall be 'OBS' - specifiying Observation as the main type of the Act instance used for documenting the diagnosis.

In XML an attribute @classCode of the element Observation represents the model attribute 'classCode' of class Observation.

Attribute 'moodCode'

@moodCode Mood Code <= EVN Attribute @moodCode specifies how to interpret the containing Act instance.

When using an Observation to specify a diagnosis, the @moodCode shall have the value EVN, indicating that the Observation documents an earlier action.

Attribute 'negationInd'

@negationInd Negation Indicator BL [0..1]

The optional attribute @negationInd is of data type BL with values 'true' or 'false'.

Specifying a 'true' value states that the specified diagnosis has been excluded.

@negationInd is optional, the default is 'false'. If not specified, the receiving system will interpret the diagnosis as specified.

Attribute 'statusCode'

statusCode Statuscode <= completed

This attribute can be use to represent the state of the containing Act, which can be in states like e.g. "new", "active" or "cancelled". As diagnoses are considered the documentation of an action already completed, the fixed value "completed" shall be used in XML attribute @code of sub-element statusCode.

An Example

A small example shows all of the above attributes:

  <observation classCode="OBS" moodCode="EVN" negationInd="true">
  …
  <statusCode code="completed"/>
  …
  </observation>

Representation of Diagnosis in specific Codesystems

ICD-10-GM-coded Diagnoses

The „International Statistical Classification of Diseases” (ICD) is a classification system for diseases and related health issues. It has a hierarchical structure. As the german localized version ICD-10-GM is a varient of the ICD-10 released by WHO.

Diseases are specified through alphanumeric codes. Each disease has a unique code and vice versa. The majority of codes are so-called primary diagnosis keys, i.e.they contain all information to encode a given diagnosis.

ICD also provides the ability to specify secondary keys for additional information. Such secondary keys must only be used together with a primary diagnosis and are marked through asterisk (*) or exclamation (!) as additional codes .

Primary diagnosis codes either have no prefix or a cross (+).

Example.: E14.30+, H28.0* ICD-10 Code for “Diabetes mellitus with cataract“

Terms of ICD-10 Codes

ICD-10-GM will be used for encoding diagnoses in both in-patient and ambulatory care. In-patient diagnosis encoding additionally has to adhere to the German coding guidelines (§ 301, Deutsche Codierrichtlinien) and the extensions authorized by the Health Ministry (BMG).

For ambulatory care, the WHO-Table with BMG-extension is to be used.

Secondary Codes

ICD-10 GM distinguishes between primary codes and secundary codes.

Primary codes are codes without suffix or with a cross(+).

Secondary codes are those codes with an asterisk (*) or an exclam (!).

In oorder to explain their meaning we will translate some quotes of „Basiswissen Kodieren“ [Basic Encoding Knowledge by DIMDI,www.dimdi.de]

"The code for etiology (cause, origin) of a disease shall be marked with a cross (+) and its manifestation with an asterisk (*) - with the cross-code being the primary code and the asterisk-code never being used alone."

Another translated quote:

„ Asterisk codes shall only be those that are marked as explicitly permitted in ICD-10 for the asterisk-suffix."

„ Provided that the secondary code is permitted for asterisk, any other code describing the underlying disease may be used as primary code with the cross-suffix."

„... Some Codes are being marked with an exclam (!) indicating that therse are further descriptions or definitions of the severity. Such codes must not be used alone“ (without primary code).

As a result, each diagnosis must at least have a primary code and optionally secondary codes.

Each primary/secondary code is the alphanumeric string given by ICD-10 code followed by the suffix, either (†, *, !)

Side Localization

Regarding the encoding of side localizations, we translated a section from „ICD-10- Bekanntmachung des BMGS“ ("ICD-10 Communications of the German Health Ministry", 2004)

„..for the application of ICD-10-GM the following holds: When encoding the side localization, the following suffices may be used: – right: R – left: L – both sides: B ...“ [BMGS, 2004]

As a result, for each ICD-10 code, an independent side localization suffix can be appended. Note: primary code and secondary code can have different side localizations.

Example: C50.4 R Mamma Ca - right J91* L Pleural effusion in conditions classified elsewhere - left

For tumor documentation the extended table is valid.

Confidence of Diagnoses

„... When using ICD-10-GM according to § 295 SGB V (ambulatory sector) additionally the following holds: For encoding the diagnosis confidence one of the follwing suffices must be used: – for an excluded diagnosis: A – for a suspected diagnosis: V – for state (without symptoms) after the given diagnosis: Z – for a validated diagnosis: G“ [BMGS, 2004, translated by author]

As a result, ambulatory diagnoses used in the context of „Abrechnung ärztlicher Leistungen“ (billing of medical services, fixed term in the German statutory GP system acc. to german federal regulation §295 SGB V) the specification of diagnosis confidence is mandatory.

For inpatient care these suffices MUST NOT be used.

Mapping of ICD-10-coded Diagnoses into HL7 v3

Structured representations of ICD10-encoded diagnoses must support primary and secondary codes, code extensions, side localizations and confidence. The primary code represents the main disease. The secondary code extends the primary code and is either used to describe manifestations in organs ("asterisk") or the cause (etiology, e.g. which bacteria) of the main disease ("exclamation") In order to represent this dependency, an additional oberservation instance will be connected via the ActRelationship to that Observation instance containing the primary code.

So we have the following basic structure for ICD10-encoded diagnoses:

Datei:Figure2.jpg Figure 2: Class Diagram of ICD-10 Diagnoses in HL7 v3

The attribute typeCode in the ActRelationship shall represent the code extension

The related Observation instance (connected via the ActRelationship) has MFST (Manifestation) as its typeCode in order to represent 'asterisk"-codes.

Exclamation-Code extensions are being represented as Observation instances connected via ActRelationships with typeCode CAUS (Cause).

The resulting XML structure of an ICD-10 encodeded diagnosis looks like this:

<!-- Structured Representation of Diagnosis-->
   <observation moodCode="EVN" classCode="OBS">
      …
      <!-- Primary Code-->
      <value xsi:type="CD" code=" E14.30" codeSystem=" 1.2.276.0.76.5.311"/>
      <entryRelationship typeCode="MFST">
         <observation moodCode="EVN" classCode="OBS">
         …
            <!-- Secondary Code-->
            <value xsi:type="CD" code=" H28.0" codeSystem=" 1.2.276.0.76.5.311"/>
         </observation>
      </entryRelationship>
   </observation>

In this case the containing ActRelationship instance is of class entryRelationship- repesented by an element of that name.

Attribute @typeCode has MFST as a fixed value for representing an asterisk code.

value.@code ICD-Code ST [1..1] XML-Attribute @code shall store the specific ICD-10 Code.

value.@codeSystem OID of ICD-Codeset UID [1..1] XML-Attribute @codeSystem shall keep the OID of the ICD-10 Version being used. The appendix gives hints towards versions being used in practice.

value.@codeSystemName Name of ICD-10 Version ST [0..1] XML-Attribute @codeSystemName may store the Name of the used ICD-10 Version.

value.@displayName ICD-Code Text ST [0..1] XML-Attribute @displayName may store the verbose text of the ICD-Code.

OIDs and names of ICD-10 versions may be obtained from DIMDI (www.dimdi.de)

Representation of Side Localisation

value.qualifier Side Localisation CR [0..1]

The side localisation code shall be represented using the child element qualifier of the value element, as it refines the specification of that diagnosis code (as decided by HL7 DE TC meeting on 2005-09-01, minutes item 1.3.2).

An example representation looks like this:

<!-- Structured Representation of a Diagnosis -->
   <observation moodCode="EVN" classCode="OBS">
      <code code="DX" codeSystem=""/>
      <!-- Primary code-->
      <value xsi:type="CD" code="E14.30" codeSystem="1.2.276.0.76.5.311">
         <qualifier>
            <name code="7" codeSystem="2.16.840.1.113883.3.7.1.0"/>
            <value code="L" codeSystem="2.16.840.1.113883.3.7.1.7"/>
         </qualifier>
      </value>
      <entryRelationship typeCode="CAUS">
         <observation moodCode="EVN" classCode="OBS">
            <code/>
            <!-- Sekundary code-->
            <value xsi:type="CD" code="H28.0" codeSystem="1.2.276.0.76.5.311">
               <qualifier>
                  <name code="7" codeSystem="2.16.840.1.113883.3.7.1.0"/>
                  <value code="B" codeSystem="2.16.840.1.113883.3.7.1.7"/>
               </qualifier>
            </value>
         </observation>
      </entryRelationship>
   </observation>

Child element 'name' within element 'qualifier' defines the type of qualifier.

Therefore, in order to express a qualifier for side localisation, the fixed value „7“ from code system OID 2.16.840.1.113883.3.7.1.0 shall be used:

   <qualifier>
      <name code="7" codeSystem="2.16.840.1.113883.3.7.1.0"/>
      <value code="L" codeSystem="2.16.840.1.113883.3.7.1.7"/>
   </qualifier>

Representation of Diagnosis Confidence

value.qualifier Diagnosis Confidence CR [0..1]

The Diagnosis Confidence can be considered an extension to the ICD-10 code, shall be represented by the child element qualifier of the value element.

<!-- Structured Representation of a diagnosis-->
   <observation moodCode="EVN" classCode="OBS">
      <code code="" codeSystem=""/>
      <!-- Primary code-->
      <value xsi:type="CD" code="E14.30" codeSystem="1.2.276.0.76.5.311">
         <qualifier>
            <name code="8" codeSystem="2.16.840.1.113883.3.7.1.0"/>
            <value code="G" codeSystem="2.16.840.1.113883.3.7.1.8"/>
         </qualifier>
      </value>
      <entryRelationship typeCode="CAUS">
         <observation moodCode="EVN" classCode="OBS" negationInd="true">
            <code/>
            <!-- Secondary code-->
            <value xsi:type="CD" code="H28.0" codeSystem="1.2.276.0.76.5.311">
               <qualifier>
                  <name code="8" codeSystem="2.16.840.1.113883.3.7.1.0"/>
                  <value code="A" codeSystem="2.16.840.1.113883.3.7.1.8"/>
               </qualifier>
            </value>
         </observation>
      </entryRelationship>
   </observation>

Child element 'name' within element 'qualifier' defines the type of qualifier.

Therefore, in order to express a qualifier for diagnosis confidence, the fixed value '8' from code system OID 2.16.840.1.113883.3.7.1.0 shall be used:

Child element 'value' within 'qualifier shall store the respective confidence value.

Possible values are listed in Table 2.

   <observation classCode="OBS" moodCode="EVN">
      ...
      <value xsi:type="CD" code="A25.1" codeSystem="1.2.276.0.76.5.311" codeSystemName="icd10gm2006">
         <qualifier>
            <name code="8" codeSystem="2.16.840.1.113883.3.7.1.0"/>
            <value code="G" codeSystem="2.16.840.1.113883.3.7.1.8"/>
         </qualifier>
      </value>
   </observation>

When representing an EXCLUDED diagnosis the attribute @negationInd shall be specified as „true“.

Specifying a Diagnosis using a Thesaurus Index

One more way of specifying a diagnosis is by using an index referring to an entry in a medical thesaurus.

Example: Mapping an Alpha-ID-coded Diagnosis

As an example, the diagnostic thesaurus „Alphabetische Verzeichnis zur ICD-10 GM“ (alphabetic directory of ICD-10 GM) is being used in Germany.

This directory allows to locate a verbose description of ICD-10 terms and to find the corresponding ICD-10 GM code.

The so-called Alpha-ID has been developed to process entries of that alphabetic directory.

It is an identification number for each textual entry in the "alphabetic directory".

In order to find this alpha-ID, a mapping file has been provided by DIMDI (www.dimdi.de).

The Alpha-ID is needed because in medical documentation, the descriptions of diagnoses need to be more differentiated than what ICD-10 codes actually can express.

Using the alpha-ID allows for a much finer granularity of diagnosis descriptions.[DIMDI,Alpha_Id].

As an example the ICD-10 Code “A01.0 Typhus caused by Salmonella typhi“ encodes multiple diagnoses such as „liver typhus“, „lung typhus“ and many more.

By using the Alpha-Id it is possible to specify the specific type of typhus, like e.g. „liver typhus“ as„I18721“ and „lung typhus“ as „I21312“.

  1;I22457;A01.0;;;Darmtyphus
  1;I75303;A01.0;;;Eberth-Krankheit
  1;I71406;A01.0;;;Enteritisches Fieber
  1;I22466;A01.0;;;Enterotyphus
  1;I22467;A01.0;;;Febris enterica
  1;I17704;A01.0;;;Gallenblasentyphus
  1;I71415;A01.0;;;Gastroenteritisches Fieber
  0;I78350;A01.0;;;Gastrointestinale Perforation bei Typhus
  1;I17794;A01.0;;;Gehirntyphus
  1;I21313;A01.0;;;Hauttyphus
  1;I22455;A01.0;;;Ileotyphus
  1;I94981;A01.0;;;Infektion durch Bacterium typhosum
  1;I73671;A01.0;;;Infektion durch Eberthella typhosa
  1;I22458;A01.0;;;Infektion durch Salmonella typhi
  1;I18721;A01.0;;;Lebertyphus
  1;I21312;A01.0;;;Lungentyphus
  1;I96251;A01.0;;;Lymphadenitis mesenterialis durch Salmonella typhi
  1;I66509;A01.0;;;Posttyphoider Abszess
  1;I22456;A01.0;;;Status typhoides
  1;I22463;A01.0;;;Typhoenteritis
  1;I71447;A01.0;;;Typhogastrisches Fieber
  1;I22462;A01.0;;;Typhoides Fieber
  1;I31416;A01.0;;;Typhomanie
  1;I22464;A01.0;;;Typhoperitonitis
  1;I22454;A01.0;;;Typhus
  1;I22461;A01.0;;;Typhus abdominalis
  1;I73926;A01.0;;;Typhusinfektion

Figure 3: Excerpt from mapping file „icd10gm2009_alphaid_edv_ascii20081006.txt“

Figure 4 shows an excerpt of the metafile which defines the fields of the mapping file for the Alpha-Id.

Each record consists of six fields, each being separated by a semicolon.

The fields in each record contain the following data:

  Field 1: Validity (0-not valid, 1-valid)
  Field 2: Stable Identification with prefix I or T ("Alpha-Identifikationsnummer")
  Field 3: Primary key (with cross)
  Field 4: Asterisk key (with asterisk)
  Field 5: Additional key (with exclamation)
  Field 6: Related text

Figure 4: Excerpt from Alpha-ID metafile „icd10gm_alphaid_edv_ascii_liesmich.txt“

A structured representation of a thesaurus uses the @value attribute of class Observation and an example instance lloks like this:

   <observation moodCode="EVN" classCode="OBS">
   …
   <value xsi:type="CD" code="I2173" codeSystem="1.2.276.0.76.5.309" codeSystemName="alphaid2006"/>
   ...
   </observation>

value.@code Alpha-Id ST [1..1] XML-Attribute @code stores the index referring to an enty in the „Alphabetisches Verzeichnis“

value.@codeSystem OID ofAlpha-ID UID [1..1] XML-Attribute @codeSystem stores the OID of the Alpha-ID Version being used.

value.@displayName Alpha-Id Text ST [0..1] XML-Attribute @displayName may be used to display a text related to the current Alpha-Id

value.@codeSystemName Name of Alpha-ID Version ST [0..1] XML-Attribut @codeSystemName represents the Name of the coding system, in our case alphaid2006.

OID and name of ICD-10 Version can be obtained from DIMDI (www.dimdi.de)

Diagnosis Specification using Identifiers in a Nomenclature

One way of specififying a diagnosis is to use the code representing a diagnostic term in some medical nomenclature.

A well-known nomenclature in medicine is SNOMED-CT ("systematic nomenclature of medicine - clinical terms")

Compared to ICD-10 it has more concepts for diagnoses and mostly does not classify.

In general using a term of a nomenclature often preserves more information than using a term of a classification.

Classification is selecting a common representation for a set of concepts that are (under some aspect) considered similar.

As a result, classification reduces information, which is demonstrated by the following examples

I.e. as a part of clinical documentation of diagnosis the encoding using alpha-id or some identifier in a nomenclature would be preferred over using a classification like e.g. ICD-10.

The example shows concepts all being represented through the same ICD-10 code Q92.8 for 'Other specified trisomies and partial trisomies of autosomes'.

A simple comparison of codes from nomenclatures gives an example of missing clarity and precision of the ICD-10 classification.

Diagnosis	ICD-10 Code	Alpha-ID	Snomed CT	ID MACS
Imbalanced Insertion	Q92.8	I87548	254262003	M002405-D62839-58
Trisomy 22	Q92.8	I81282	205655003	M001897-D55549-58
Trisomy 20	Q92.8	I81283	53346000	M002406-D55530-58
Partial Trisomy a.n.k.	Q92.8	I81284	133849008	M001D1C-C78409-58

Table 6: Diagnoses in different coding systems

Precoordinated and Postcoordinated Concepts of a Nomenclature

For specifiying a diagnosis using a terminology there are two fundamental approaches:

The pre-coordinated approach selects a fixed term among a comprehensive list with representations for all possible concepts.

The list of all pre-coordinated terms limits the set of concepts which can be represented.

The post-coordinated approach constructs each term out of (more or less independently) encoded aspects of the concept to be represented.

The resulting term is the combination of the encoded aspects of the given concept.

ICD-10 is a good example of a pre-coordinated terminology, as it lists all the terms for the concepts it can represent.

The cross-asterisk extension to ICD-10 is an example of post-coordination.

More info can be found under the Terminfo project [Terminfo] of HL7 International.

Diagnosis by Thesaurus Index or Term within a Nomenclature

A term in a nomenclature is specified through the @value attribute of class Observation.

An example (SNOMED CT) of the structured representation looks like this:

   <observation moodCode="EVN" classCode="OBS">
   ...
   <value 
      xsi:type="CD" code="314888007" 
      codeSystem="2.16.840.1.113883.6.96"
      codeSystemName="SNOMED CT"
      displayName="Typ-II-Diabetes with diabetic cataract"/>
   ...
   </observation>

Attribute value.@code Index or Term in Nomenclature

CD CWE [1..1] The XML attribute @code keeps the index referring to an entry in a thesaurus or nomenclature.

Attribute value.@codeSystem OID of Nomenclature

UID [1..1] The XML attribute @codeSystem stores the OID of the thesaurus or nomenclature.

Attribute value.@displayName Text

ST [0..1] Through the XML attribute @displayName a plain text related to the index can be given.

Attribute value.@codeSystemName Name of Nomenclature

[0..1] The XML attribut @codeSystemName describes the name of the thesausrus or nomenclature.

Representation of Cancer Diagnosis

Introduction

In this chapter, diagnostic aspects of documentation of tumor diseases will be described. Different aspects of diagnostical descriptions of tumor diseases are described by ICD-O (Oncology) and by further classifications to document the expansion (tumor spread) or diseases stage, respectively, the latter one mostly being classified by the TNM-System.

Especially for hemato oncological diseases (Leukemias and Lymphomas), other systems (e.g. Ann-Arbor-Classification) are used. TNM-System discribes:

• Expansion of primary tumor (extent or, spread in distant organs repectively)
• Affection of lymph nodes in lymph flow area
• Existence of distant metastases.

For non-TNM–-classifiable diseases or in addition to the TNM-System there are a number of further classification systems:

• Ann Arbor
• Rai
• Binet
• CML-Phasen
• FAB
• Durie and Salmon
• Gleason-Score

Discriptions can be found here: http://www.med.uni-giessen.de/akkk/gtds/grafisch/doku/bd5f.htm http://www.tumorzentren.de/tl_files/dokumente/adt_basis.pdf

This list probably will be always incomplete because of the medical progress.

ICD-O

Third Edition of ICD-O [DIMDI, WHO] is the topical one. ICD-O consists of two axes, Topography- and Morphology-Axis. In ICD-O, tumor can be classified by

• Site
• Tissue Structure (Histology)
• Biological behaviour (Dignity)
• Tissue grading (mostly in two or four stages)

In this case, tissue structure and tissue grading is redundant. Precisely: The first four digits of morphology-code describe tissue-type. The fifth one describes biological behaviour (dignity-code):

• /0 = benign
• /1 = neoplasm with uncertain or unknown behaviour
• /2 = Cancer in situ
• /3 = malignant, primary tumor
• /6 = malignant, metastasis (not used in tumor documentation)
• /9 = malignant, uncertain wether primary tumor or a metastatic

The sixth digit describes grading, differentiation or phenotype (Histology/Pathology):

• 1 = Grade I, well differentiated (Low grade)
• 2 = Grade II, moderately differentiated (Intermediate grade)
• 3 = Grade III, poorly differentiated (High grade)
• 4 = Grade IV, undifferentiated (High grade)
• 9 = Grade IX, grade cannot be assessed

For Leukemias and Lymphomas, the sixth digit signifies the immunophenotype

• 5 = T-Cell
• 6 = B-Cell, Pre-B-Cell, B-Ancestor-Cell
• 7 = Null-Cell, Not-T-Cell-Not-B-Cell
• 8 = NK-Cell, Natural Killer Cell
• 9 = Determination of Cell Type was not accomplished, not specified or not applicable

TNM System describes

• Expansion of primary tumor (extent repectivly spread in distant organs)
• Affection of lymph nodes in lymph flow area
• Exisistence of distant metastasis

For the topography axis, there exists an (hierarchical) enlargement, the ‘localisation key’ (Wagner, G. (HRSG.): Tumorlokalisationsschlüssel, 5. Auflage, Springer Verlag, Berlin, Heidelberg, New York, Tokyo 1993), which can supply at some positions clinical relevant differentiation. The morphology axis is composed of a four-digit code for tissue basic structure, a characteristic number for dignity and an additional grading item. The key itself does not contain all possible combinations of histology and dignity, but points out those ones, for whome exist special discriptions. Vice versa not all combinations of basic structure and dignity are possible (so there is no ‘benign leukemia’). Not either there is a grading system available for all kinds of tumor. For some ones, additional information (for Example ‘Cell-line’) is used at the corresponding position.

Tumor Localization

For Tumor-Coding first of all, the site is important. It will be classified by the Topography -Axis of ICD-O. Topographical -Codes of ICD-10 are based on chapter II (Neoplasm –C 00 – C 97) of ICD-10. However, some of the topographical Codes of ICD-10 (Codes) are not used, because their content is discribed by histology- and digit-Codes of ICD-O. (e.g. Differentiation in situ/ infiltrated, melanoma vs. scin cancer).

Tumor Histology and Dignity

Furthermore, in ICD-O, tumor morphology i.e. tissue structure (histology) and biological behavior (dignity) is discribed by special Codes. Tumor histology is coded by a four-digit number, which is assumed of the morphology-axis of Standardized Nomenclature of Patholoy (SNOP). Dignity-Code is attendant on morphology-Code, seperated by /. Examples:

• 8060/0 squamous epithelium - papillomatose
• 8070/2 squamous epithelium – cancer in situ undifferentiated
• 8070/3 squamous epithelium – cancer undifferentiated
• 8070/6 squamous epithelium – cancer metastasis undifferentiated

Tumor Grading

Grading is derived from the comparison of primary tissue with the neoplasm of this tissue. There are five grading-degrees (s.o.) and further three degrees for Malignant Lymphoma. Registration of tumor grading is also provided in TNM.

Qualifier of Tumor Formula

ICD-O –Codes can be specified by the following qualifier:

Here ICD-O provides additionally the following codes for Lymphoma, which specify the Cell line: B-Cell, T-Cell, Null-Cell Lymphoma. ICD-O uses the Codes 1 – 9. A detailled System is discribed in Chapter 9 under 9.5.2 and 9.53.

Example

GRAPHIC IS MISSING

DisplayName is only available in correlation to qualifiers. According to ICD-O-3 formation rule there are much more discriptions possible as ICD-Catalog proposes.

TNM Classification

The TNM classification describes the expansion (spread) of the tumor , i.e. stadium and prognosis of the disease.

As a special feature, the TNM classification uses the same notation for all tumors but supports different interpretations for different entities.

As an example, a T3 for mamma carcinoma has a different interpretation than the stomach carcinoma.

The current edition is 7th which is valid since January 2010, which is a reason why many TNM-6- codes may still be in use. Therefore all TNM-codes should have a version identifier, because non translatable differences are in the different editions.

A simple overview can be found in http://de.wikipedia.org/wiki/TNM.

The T category will be used for the expansion of the primary tumor, where the stages T0, Tis, T1-T4 und TX are being used, the "higher" the number, the more progress is being diagnosed and the more adverse the prognosis.

T0 stands for "no primary tumor found" (e.g. because being eradicated by therapy) Tis stands for a very early (non-infiltrating) stage tumor (Tumor in situ) and TX stands for a diagnosis which can not judge the stage because of missing data

For some tumors subcategories like e.g. T2a, T2b have been defined.

The N-category classifies the affection of lymphatic nodes - usingN0, N1-N3, NX, where N0 means "no lymphatic node affected".

For some tumors, this exclusion ("N0") requires the examination of a minimum amount of nodes.

The higher the N category the more severe is the lymphatic node affection.

If no sufficient data is available NX is being diagnosed.

The M category describes the existence of distant metastases, with the vallues of M0 (no metastases detectable), M1 (metastases detectable) and MX (insufficient data).

The TNM can be used according to clinical criteria (preoperative, cTNM) and according to the pathology findings (pTNM).

For many patients one single diagnoss will be made, either a cTNM or a pTNM, such that this type of finding must be distinguished.

This preoperative ("c" or no prefix) / pathology ("p") attribute can be captured independently for each of the T N M categories.

Therefore the typically used pTNM often meanes pTpNcM, because the spread of a timur can best be diagnosed through surgery while lymphatic spread only by pathology.

The prefix "r" describes remaining tumors (after non-disease intervals) and a prefix "y" if the classification was assessed after systemic or radiation treatment (ycTNM, ypTNM etc.).

For multiple Primary tumors the suffix "m" (or the number of tumors) will be put after the T-category value(T2(m), T2(5)).

Therefore a complete TNM formula looks like this:

There are voluntary components e.g. the certainty-Faktor (C-Factor)

Other components require pathology lab examination (L-, V- or Pn-Category)

• y-Symbol (y or empty, disgnosis after systematic or xray treatment)
• r-Symbol (r or empty, remainder)
• p/c/a-Symbol for pT-category (clinical or pathological)
• T-Category
• (m) for multiple localizations or number of tumors
• C-Factor for T-Category (certainty)

• L-Category
• V-Category
• Pn-Category
• p/c/a-Symbol for pN-Category (clinical or pathological)
• N-Category
• C-Factor for N-Category (certainty)

• p/c/a-Symbol für pM-Category
• M-Category
• C-Factor for M-Category (certainty)
• S-Kategorie (serological values, only for testicle tumors)
• UICC-Stadium (Grading via UICC 0 and I-IV together with

letter A, B and C for further classification).

For some tumors further modifiers are being documented as a suffix (mostly in parenthenses) like e.g. (sn), (mol-),(mol+).

In addition, the TNM supplement introduces innovative or "under test" extensions, which raises doubts whether ta full control of TNM entries.

Typical T-Categories (without pre-/suffices) are being listed in chapter "Sites"

Typical N-Categories (without pre-/suffices) are being listed in chapter "Nodes".

Typical M-Categories (without pre-/suffices) are being listed in chapter "Metastases".

9 Reference: DKFZ

Qualifiers of the Tumor Formula

Despite values for T,N and M the TNM formula may also contain various qualifiers. The following table gives an overview which qualifiers can be used for which information and where they are being used. This is case-sensitive!

• a Autoptical
• c Clinical
• C C-Factor (certainty)
• G histopathological Grading
• L Lymphatic vessel invasion
• m multiple Tumors
• M distant metastases
• N Regional lymphatic node metastases
• p pathological
• Pn perineural Invasion
• r Rezidiv tumor
• R Residual tumor after treatment
• sn Sentinel-Lymphatic nodes
• Stage Anatomic Stage-Grouping
• T Expansion (spreading) of Primary tumor
• V Venous invasion
• y Classification after initial multi-modal Therapy

Ann Arbor Classification

For lymphoma the TNM-classification does not make sense and therefore theso-called Ann-Arbor classification will be applied.

In this system, the stages I-IV are being distinguished, with an additional suffix letter

• A meaning "no general symptoms"
• B "with general symptoms"
• E "extra-lymphatic organ affected"
• S "spleen affected"

As with TNM, the Ann-Arbor classification distinguishes between clinical (cS) and pathological (pS) grading.

According to Durie & Salmon tere are gradings from I to III or the grades according to SWOG from 1-4 for the "Multiple Myeloma".

FIGO Stages

FIGO stages ignificantly overlap with the TNM classification, especially on the T-axis.

Therefore no details are being given here.

Gleason Score

The so-called Gleason-Score serves to classify the prostate carcinoma. The total numeric value is the sum of two indicators for • loss of differentiation (1-5) • growth pattern (1-5)

Resulting values range from 2 to 10 (also see Scores & Assessment DSTU).

Furthermore there is a more recent Gleason classification (according to Dhom, Müller and Helpap [Helpap 2002, Helpap2007]), which also requires to specify the procedure (esp. the two degrees) being used.

Papanikolaou

The so-called Pap-Test [Pap] is based on colored cell samples from the cervix and is used as an early indocator for cervical cancers.

WHO Grading

The so-called WHO Grading serves as an individual progonosis on the one hand and also is an indicator towards further treatment on the other hand.

Tumors of WHO Grade I and II in most cases can be treated by surgery alone, while tumors with WHO Grading III and IV normally need additional treatment by radiation or chemotherapie after surgery.

The grading looks like this:

Code	Codename	Meaning
I		benign,slow growth of tumor, very good prognosis
II		still benign, slow growth of tumor,tendency to recur
III		malignant,actively producing abnormal cells,tends to recur
IV		very malignant,fast growth,needs systemic therapy, bad prognosis

Table 9: WHO Grading (OID 1.2.276.0.76.5.394)

The fourth edition of the "World Health Organization (WHO) Classification of tumours of the central nervous system" (2007) lists all relevant tumor entities.

Also see "Brain Tumor Basics" (http://www.abta.org/sitefiles/sitepages/524309b806778d4f7b79044d97f324ea.pdf)

Conclusion

The following data of tumors can be represented by these respective classifications (through values and/or modifiers)

Concept	Classification
Tumor localisation	ICD-O
Morphology + dignity	ICD-O
Tissue differentiation ICD-O	ICD-O/TNM
type of stage codes (c,p,r,y)	TNM/Ann-Arbor
T Code + C Factor, multiplicity	TNM
M Code + C Factor, multiplicity	TNM
N Code + C Factor, multiplicity	TNM
Residual Tumor	TNM
stage grouping	TNM/Ann-Arbor/Durie&Salmon/SWOG

Cancer Diagnosis in HL7 V3

Representing Cancer Diagnoses in HL7

Tumor diagnoses shall be represented in HL7 V3 according to the following schema: A centralised instance of Observation shall specify the ICD-O code in the 'value' model-attribute with Dignity and (differentiation) grading in its 'qualifier' sub-element.

Further details shall be represented in more Observation-instances being connected via supporting ActRelationShip instances with typeCode:=SPRT .

The CertaintyFactor shall be in the 'qualifier' sub-element of the model-attribute 'value' but only for those Observation instances which represent a T-, N- or M-Classification.

Multiplicity shall be in one more Observation instance related (supporting ActRelationShip) to that Observation instance representing the T-Classifier.

Tree View of HL7-based Representation of Cancer Diagnosis

 +- ICD-O (Dignity, Grading)
 +- T-Category (c, p, r, y)
 | +- Multiplicity
 +- N-Category (c, p, sn)
 | +- Number of nodes examined and marked positive
 +- M-Category (c, p)
 +- Residual Tumor
 +- Grading
 +- Cell Type
 +- Lymphatic Invasion
 +- Venous Invasion
 +- Perineural Invasion
 +- Staging
 +- Ann-Arbor
 +- Gleason-Score

Code	Codename	Class / Path	Representation (Observation or Qualifier)
DF	Differenzierungsgrad	Observation (ICD-O)	qualifier.@name
DN	Dignität	Observation (ICD-O)	qualifier.@name
T	T	support-Observation	Observation/value.@code
M	M	support-Observation	Observation/value.@code
N	N	support-Observation	Observation/value.@code
MP	Multiplicity	support-Observation (T)-support-Observation	Observation/value.@code
CF	Certainty Factor	support-Observation(T or N or M)	qualifier.@name
RS	Residual tumor	support-Observation	Observation/value.@code
GR	Grading	support-Observation	Observation/value.@code
LI	Lymphatic invasion	support-Observation	Observation/value.@code
VI	Venous invasion	support-Observation	Observation/value.@code
SG	Staging	support-Observation	Observation/value.@code
AA	Ann-Arbor-Classification	support-Observation	Observation/value.@code

Table 10: Codes for Tumor Diagnoses (OID 1.2.276.0.76.5.334)

Example

<observation classCode="OBS" moodCode="EVN">
  ...
  <value xsi:type="CD" code="8070" codeSystem="2.16.840.1.113883.6.43.1"
    displayName="Plattenepithelkarzinom"
    codeSystemName="icd-o-3">
    <qualifier>
      <!-- Dignity -->
      <name code="335" codeSystem="2.16.840.1.113883.3.7.1.0"/>
      <value code="0" codeSystem="1.2.276.0.76.5.335"/>
    </qualifier>
    <qualifier>
      <!-- Differentiation/Grading -->
      <name code="336" codeSystem="2.16.840.1.113883.3.7.1.0"/>
      <value code="1" codeSystem="1.2.276.0.76.5.336"/>
    </qualifier>
  </value>
  <!-- Tumor formula -->
  <entryRelationship typeCode="SPRT">
    <observation moodCode="EVN" classCode="OBS">
      <!-- T-Code -->
      <value xsi:type="CD" code="T1" codeSystem="2.16.840.1.113883.15.8" codeSystemName=" tnm5"/>
        <qualifier>
          <name code="341" codeSystem="2.16.840.1.113883.3.7.1.0"/>
          <value code="C2" codeSystem="1.2.276.0.76.5.341"/>
        </qualifier>
      </value>
    </observation>
  </entryRelationship>
  <entryRelationship typeCode="SPRT">
    <observation moodCode="EVN" classCode="OBS">
    <!-- N-Code -->
      <value xsi:type="CD" code="N2" codeSystem="2.16.840.1.113883.15.8" codeSystemName="tnm5"/>
      </value>
    </observation>
  </entryRelationship>
  <entryRelationship typeCode="SPRT">
    <observation moodCode="EVN" classCode="OBS">
    <!-- M-Code -->
      <value xsi:type="CD" code="M0" displayName="Fernmetastasen nicht vorhanden"
        codeSystem="2.16.840.1.113883.15.8" codeSystemName="tnm5"/>
      </value>
    </observation>
  </entryRelationship>
</observation>

Representation for specific Use Cases

Introduction

The following sections present examples for structured diagnosis representations in selected applications.

GP/Ambulatory Billing Diagnosis (Germany)

This example shows a so-called "KVDT Record" according to §295 (German Federal Code SGB V) with a diagnosis to be represented through HL7 version 3.

Diagnosis fields in the current KVDT record:

FK	Usage	Field Name	Field Type	Conditions	Explanations
6001	n	ICD-Code	m	Rule 486 Rule 488 Rule 489 Rule 490 Rule 492	see chapter 7
6003	1	Diagnosis Confidence	m	Rule 484	see chapter 7
6004	1	Side Localization	k		see chapter 7
6006	n	Diagnosis Explanations	k		see chapter 7
6008	n	Diagnosis Exception Case	m	Rule 491
3673	n	Continued Diagnosis (ICD-Code)	m	Rule 486 Rule 488 Rule 489 Rule 490 Rule 492
3674	1	Diagnosis Confidence/ Continued Diagnosis	m
3675	1	Side Localization Continued Diagnosis	k
3676	n	Diagnosis Explanation Continued Diagnosis	k
3677	n	Diagnosis Exception Case Continued Diagnosis	m	Regel 491

Table 11: GP/Ambulatory Billing Diagnoses (Germany) ref 10,11

Multiple ICD-10 codes may be specified - without a (mandatory) check of its medical validity but with at least one primary ICD-10 code being required.

With each code, a ide localization, a diagnosis confidence, diagnosis explanations and exception cases may be specified.

Control code 6001 indicates a (current) billing diagnosis, while control code 3673 indicates a continued diagnosis.

• 10 FK: Field (control) code
• 11 m = MANDATORY, k = OPTIONAL

Example in HL7-V3:

<!-- Diagnose (Abrechnungsdiagnose) 6001-->
<!-- :A17.0+;G01*;;Tuberkulöse Meningitis Gesichert Rechts-->
<!-- Diagnose 1***************************************************************-->
…
<observation classCode="OBS" moodCode="EVN">
  <!-- Code für Abbrechungsdiagnose 6001-->
  <code code="XXX_DX" codeSystem="2.16.840.1.113883.5.4"/>
  <!-- Diagnoseerläuterung 6006**********************************************-->
  <text/>
  <!-- Primärcode 6001*******************************************************-->
  <value xsi:type="CD" code="A17.0" codeSystem="1.2.276.0.76.5.311"
    codeSystemName="icd10gm2006">
    <!-- Diagnosesicherheit 6003-->
    <qualifier>
      <name code="DSH" codeSystem="111.111.1.1.1"/>
      <value code="G" codeSystem="1.2.276.0.76.3.1.1.5.1.21"/>
    </qualifier>
    <!-- Seitenlokalisation 6004-->
    <qualifier>
      <name code="SL" codeSystem="111.111.1.1.1"/>
      <value code="R" codeSystem="1.2.276.0.76.3.1.1.5.1.22"/>
    </qualifier>
  </value>
  <!-- Ausnahmetatbestand zu Primärcode**************************************-->
  <entryRelationship typeCode="RSON">
    <observation classCode="OBS" moodCode="EVN">
      <code nullFlavor="NI"/>
      <value xsi:type="ST">…</value>
    </observation>
  </entryRelationship>
  <entryRelationship typeCode="MFST">
  <!-- Sekundärcode 6001*************************************************-->
    <observation classCode="OBS" moodCode="EVN">
      <code code="XXX_DX" codeSystem="2.16.840.1.113883.5.4"/>
      <!-- Diagnoseerläuterung 6006**************************************-->
      <text>Diagnoseerläuterung</text>
      <value xsi:type="CD" code="G01" codeSystem="1.2.276.0.76.5.311" codeSystemName="icd10gm2006">
        <!-- Diagnosesicherheit 6003-->
        <qualifier>
          <name code="DSH" codeSystem="2.16.840.1.113883.3.7.1.0"/>
          <value code="G" codeSystem="1.2.276.0.76.3.1.1.5.1.21"/>
        </qualifier>
        <!-- Seitenlokalisation 6004-->
        <qualifier>
          <name code="SL" codeSystem="2.16.840.1.113883.3.7.1.0"/>
          <value code="R" codeSystem="1.2.276.0.76.3.1.1.5.1.22"/>
        </qualifier>
      </value>
      <!-- Ausnahmebegründung zum Sekundärcode 6008***********************-->
      <entryRelationship typeCode="RSON">
        <observation classCode="OBS" moodCode="EVN">
          <code nullFlavor="NI"/>
          <value xsi:type="ST">…</value>
        </observation>
      </entryRelationship>
    </observation>
  </entryRelationship>
</observation>

Diagnosis in the Referral Letter / Medical Documentation

The Implementation Guideline „Arztbrief“ (www.hl7.de) as well as related documents lists various examples of how to represent diagnoses via HL7 V3/CDA Release 2 (see [CDAr2Arztbrief]).

Terminology

Introduction

This chapter separates codes in use from normative specifications, in order to allow updates to such codes without having to rewrite the normative part. Therefore this chapter is just informative. Current codes have to be requested.

Due to pending third-party copy rights regarding some of the the following tables, the textual descriptions may not be given here such that the respective fields remain empty.

Overview of Value Sets

Value Sets	OID	Short Term	German	English
Tumors	1.2.276.0.76.11.1	uicctumor	ValueSet für Tumore in der Tumordokumentation	ValueSet for tumors in the cancer documentation
Nodes	1.2.276.0.76.11.2	uiccodes	ValueSet für Knoten in der Tumordokumentation	ValueSet for nodes in the cancer documentation
Metastases	1.2.276.0.76.11.3	uiccmetastasen	ValueSet für Metastasen in der Tumordokumentation	ValueSet for metastases in the cancer documentation
ResidualTumor	1.2.276.0.76.11.4	uiccresidualtumor	ValueSet für Residualtumor in der Tumordokumentation	ValueSet for residual tumor in the cancer documentation
Stage Classification	1.2.276.0.76.11.5	uiccstages	ValueSet für die Stadiengruppier ung in der Tumordokumentation	ValueSet for stages in the cancer documentation
Venous Invasion	1.2.276.0.76.11.6	uiccveneninvasion	ValueSet für die Veneninvasion in der Tumordokumentation	ValueSet for venous invasion in the cancer documentation
Lymphatic Invasion	1.2.276.0.76.11.7	uicclymphsysteminvasion	ValueSet für die Lymphsysteminvasion in der Tumordokumentation	ValueSet for the lymphatic system invasion in the cancer documentation
Perineural Invasion	1.2.276.0.76.11.8	uiccneuralscheideninvasion	ValueSet für die Neuralscheideninvasion in der Tumordokumentation	ValueSet for the perineural invasion in the cancer documentation
TNM Qualifier	1.2.276.0.76.11.9	uicctnmqualifier	ValueSet für die TNM-Qualifier in der Tumordokumentation	ValueSet for tnm qualifier in the cancer documentation
TNM Localisation for Tumor Documentation	1.2.276.0.76.11.10	uicclocalisation	ValueSet für die TNM-Seitenlokalisation in der Tumordokumentation	ValueSet for tnm localisation in the cancer documentation

Table 12: Value Sets

UICC 5. Edition (OID 2.16.840.1.113883.15.8) UICC 6. Edition (OID 2.16.840.1.113883.15.7) UICC 7. Edition (OID 2.16.840.1.113883.15.6)

Overview of Coding Schemata

Vocabulary Domain/Coding System	OID	Short Term
ICD10GM
ICD­10 GM Version 2012	1.2.276.0.76.5.409	icd10gm2012
ICD­10 GM Version 2011	1.2.276.0.76.5.388	icd10gm2011
ICD­10 GM Version 2010	1.2.276.0.76.5.384	icd10gm2010
ICD­10 GM Version 2009	1.2.276.0.76.5.356	icd10gm2009
ICD­10 GM Version 2008	1.2.276.0.76.5.330	icd10gm2008
ICD­10 GM Version 2007	1.2.276.0.76.5.318	icd10gm2007
ICD­10 GM Version 2006	1.2.276.0.76.5.311	icd10gm2006
ICD­O
ICD­O­3	2.16.840.1.113883.6.43.1	icd­o­3
ICD­O­DA­1978	n.a.
ICD­O­DA­2002	n.a.
TNM
C­Faktor	1.2.276.0.76.5.341	c­faktor­tumor
TNM 5. Edition	2.16.840.1.113883.15.8	tnm5
TNM 6. Edition	2.16.840.1.113883.15.7	tnm6
TNM 7. Edition	2.16.840.1.113883.15.6	tnm7
Dignity	1.2.276.0.76.5.335	dignitaet­tumor
Cell­ Type	1.2.276.0.76.5.413
Validity R­Classification	1.2.276.0.76.5.414
Existence of Residual Tumor	1.2.276.0.76.5.415
Tumor Diagnoses	1.2.276.0.76.5.334	tumordiagnosen
Grading	1.2.276.0.76.5.336	grading_tumor
­Localisation of Metastases	1.2.276.0.76.5.401
Scores
Gleason­Score
Gleason­Score: Loss of Differentiation	1.2.276.0.76.5.402
Gleason­Score: Growth Pattern	1.2.276.0.76.5.403
Gleason­Score: Grading	1.2.276.0.76.5.404
Ann­Arbor	1.2.276.0.76.5.405
Papanikolaou: Grading	1.2.276.0.76.5.406
Alpha­ID
Alpha­ID 2012	1.2.276.0.76.5.408	alphaid2012
Alpha­ID 2011	1.2.276.0.76.5.387	alphaid2011
Alpha­ID 2010	1.2.276.0.76.5.383	alphaid2010
Alpha­ID 2009	1.2.276.0.76.5.355	alphaid2009
Alpha­ID 2008	1.2.276.0.76.5.329	alphaid2008
Alpha­ID 2007	1.2.276.0.76.5.316	alphaid2007
Alpha­ID 2006	1.2.276.0.76.5.309	alphaid2006
MeSH
MeSH	2.16.840.1.113883.6.177.5	MSHGER
Snomed CT
SNOMED CT	2.16.840.1.113883.6.96	SNOMED CT
ID Macs
ID Macs	1.2.276.0.76.5.305	id_macs
Typing Diagnosis	1.2.276.0.76.5.342

Table 13: Coding Schemata

Diagnosis Types In Germany

The following codes are being used for typing of diagnoses. This table is a pragmatic collection of the current state-of-the-art in german systems. An international classification is not available at this time.

Code	Meaning
DX	Diagnosis, not specified any further
RFFDX	Referral Diagnosis
ENTDX	Entry Diagnosis
TRFDX	Transfer Diagnosis
ADMDX	Admittance Diagnosis
CDDX	Clinical Department’s Diagnosis
CDXDX	Clinical Department’s extra Diagnosis
CDTDX	Clinical Department’s Treatment Diagnosis
CDDISDX	Clinical Department’s Discharge Diagnosis
CDADMDX	Clinical Department’s Admittance Diagnosis
SUCCDX	Successive Diagnosis (with continuing sick leave)
DISDX	Discharge Diagnosis
TDX	Transfer Diagnosis
PERMDX	Permanent Diagnosis
APERMDX	Anamnestic Permanent Diagnosis
BPERMDX	Treatment-related Permanent Diagnosis
EMERDX	Emergency-related Diagnosis
REIMDX	Reimbursement Diagnosis
POSTOPDX	Post-operative Diagnosis
PREOPDX	Pre-operative Diagnosis
ADR	UAW ­Observed Unwanted Side Effects
ADRPD	UAW Main Disease
ADRCCD	UAW Side Disease
IFSGDX	If–G ­Diagnoses
IFSGSUSPDX	If–G ­Suspicious Diagnoses
IFSGDD	If–G ­Differential Diagnoses
COD	Cause of Death (fatal disease)
CCCOND	Accompanying Diseases
EXTCS	External Cause
NEO	Neoblasts
UAE	Unwanted Medication Event
UAW	Unwanted Medication Effect12
CAREDX	Care Diagnosis
SYMDX	Symptom
OTHDX	Miscellaneous Diagnosis

Table 14: Diagnosis Types (OID 1.2.276.0.76.5.342)

ICD-O Codes

Dignity

Dignity refers to a tumor property related to their biological behavior in the body. 13

Meaning	Code
0	benign
1	Neoplasm with uncertain or unknown behaviour
2	Carcinoma in situ
3	malign, Primary Tumor
6	malign, Metastasis
9	malign, not differentiated between Primary Tumor or Metastasis

Table 15: Dignity Codes (OID 1.2.276.0.76.5.335)

12 In this case, a cause has to be documented along with the diagnosis – but that is not covered in this implementation guide. It also has to be clarified whether such diagnosis is equal to “suspicious for”. 13 DIMDI www.dimdi.de ICD10GM, ICDO3

Grade of Differentiation/Grading

The following table lists possible gradings. The entity column lists to what tumor entities these grades apply. ref.14

Code	Description	German	Entity
0	Primary acquired melanosis		Malignant Melanoma of Conjunctiva
1	well differentiated	Gut differenziert	all but Prostata, Malignant Melanoma of Conjunctiva
	Well differentiated (slight anaplasia) (Gleason 2­4)		Prostata
	Malignant melanoma arising from a naevus		Malignant Melanoma of Conjunctiva
2	moderately differentiated	Mäßig differenziert	all but Prostata, Malignant Melanoma of Conjunctiva
	Moderately differentiated (moderate anaplasia) (Gleason 5–6)		Prostata
	Malignant melanoma arising from primary acquired melanosis		Malignant Melanoma of Conjunctiva
3	poorly differentiated	Schlecht differenziert	all but Prostata, Penis, Kidney, Renal Pelvis and Ureter, Urinary Bladder, Urethra, Malignant Melanoma of Conjunctiva
	Malignant melanoma arising de novo		Malignant Melanoma of Conjunctiva
3­4	Poorly differentiated/ undifferentiated (marked anaplasia) (Gleason 7– 10)		Prostata
	Poorly differentiated/ undifferentiated		Penis, Kidney, Renal Pelvis and Ureter, Urinary Bladder, Urethra
4	undifferentiated	Undifferenziert	all but Prostata, Penis, Kidney, Renal Pelvis and Ureter, Urinary Bladder, Urethra, Malignant Melanoma of Conjunctiva
9			Grading not performed, not given or not applicable
L	low malignity (G1­G2)	Niedriggradig maligne (G1­G2)
M	intermediate malignity (G2­G3)	Mittelgradig maligne (G2­G3)
H	high malignity (G3­G4)	Hochgradig maligne (G3G4)
B	Borderline	Grenzfall
X	grade of differentiation cannot be assessed	Differenzierungs­grad nicht be­stimmbar

This Grading may either be a qualifier in a containing ICDO or be documented as a component in a stand-alone code.

Table 16:Grade of Differentiation/Gradings (OID 1.2.276.0.76.5.336) 14 DIMDI www.dimdi.de ICD-O-3

Cell Type

This qualifier identifies the immune phenotype related to a lymphoma.

Code	Meaning	Explanation
T	T­ cell type	affects T ­lymphocytes
B	B­ cell type	affects B lymphocytes
N	Null cell type	NHL  Th0, null cell type lymphoma (and T-cell)
K	Natural­ Killer cell type	affects NK­ cells: rare lymphoma, mostly in nose or of nasal type
X		not determineable (undifferentiated lymphoma)
9		affected cell type determination not performed, not specified or not applicable
U		unknown, nullFlavor=UNK

Table 17: Lymphoma-Affected Cell Type (OID 1.2.276.0.76.5.413)

Validity of R Classification

This qualifier documents the focus of the Residual¬ Classification15.

Code	Meaning	Explanation
L	locoregionary tumor	nearby tumor(s)
M	distant metastasis	distant secondary tumors
G	overall phenomenon

Table 18: Validity of R-Classifikation (OID 1.2.276.0.76.5.414) 15 Altmann based on TNM V7, Giessen, 2010

Existence of Residual Tumor

This qualifier indicates, where a Residual Tumor exists ref. 16.

Code	Meaning	Explanation
L	locoregionary tumor	nearby tumor(s)
F	distant metastasis	distant secondary tumors
B	both
U	unknown	nullFlavor=UNK

Existence of residual Tumor

16 Dudeck J. Basisdokumentation für Tumorerkrankte. Giessen. 1999.

Codes for TNM-Classification

Tumors

This section lists known T-Categories ref. 17 (without representing possible extensions). Descriptions vary with the related entity. Codes shall be used along with tumor diagnosis, as one code may have different meanings. (e.g. T1 may refer to 23 cm or 24 cm).

Code	Description	Explanation	5.	6.	7.
Ta			X	X	X
Tis	Carcinoma in situ	non invasive	X	X	X
T0	No evidence of primary tumour			X	X
T1			X	X	X
T1mic		micro invasion	X	X	X
T1a			X	X	X
T1a1			X	X	X
T1a2			X	X	X
T1b			X	X	X
T1b1			X	X	X
T1b2			X	X	X
T1c			X	X	X
T1d					X
T2			X	X	X
T2a			X	X	X
T2a1					X
T2a2					X
T2b			X	X	X
T2c			X	X	X
T2d					X
T3			X	X	X
T3a			X	X	X
T3b			X	X	X
T3c			X	X	X
T3d				X	X
T4			X	X	X
T4a			X	X	X
T4b			X	X	X
T4c			X	X	X
T4d			X	X	X
T4e					X
TX	Primary tumor cannot be assessed	Stage of primary tumor cannot be determined

Table 20: (T) Tumor Codes Value Set (OID 1.2.276.0.76.11.1) 17 TNM 5.,6.,7. Edition

Nodes

Any code for involvement of lymph nodes shall only be used together with tumor diagnosis.

				UICC	UICC	UICC
Code	Description	Meaning	Entity	5.	6.	7.
N0	No regional lymph node metastasis	no lymph node affected	all	X	X	X
N1				X	X	X
N1mi	Bilateral regional lymph node metastasis		vulva		X	X
N1a			all	X	X	X
N1b				X	X	X
N1b1				X
N1b2				X
N1b3				X
N1b4				X
N1c					X	X
N2				X	X	X

Table 21: (N) Lymph Node Codes Value Set (OID 1.2.276.0.76.11.2)

Metastasis

Code describing distant metastases shall only be used together with tumor diagnosis.

Code	Description	German	Entity	5.	6.	7.
				UICC	UICC	UICC
M0	No distant metastasis	Fernmetastasen nicht vorhanden	all	X	X	X
M1	Distant metastasis	Fernmetastasen vorhanden	all	X	X	X
M1a			only oesophagus / prostate	X	X	X
M1b			only oesophagus / prostate	X	X	X
M1c				X	X	X
M1d						X
M1e						X
MX	Distant metastasis cannot be assessed		all	X	X	X

Table 22: (M) Metastasis Code Value Set (OID 1.2.276.0.76.11.3)

Residual Tumor

Code	Description	German
R0	No residual tumour	kein Residualtumor
R1	Microscopic residual tumour	nur mikroskopisch Residualtumor nachweisbar
R2	Macroscopic residual tumour and	makroskopischer Residualtumor und
R2a	microscopically not confimed	­mikroskopisch nicht bestätigt
R2b	microscopically confimed	­mikroskopisch bestätigt
RX	Presence of residual tumour cannot be assessed	Unbekannt

Table 23: Residualtumor Codes Value Set (OID 1.2.276.0.76.11.4)

Stage grading as of UICC

Code	Description	Meaning	5.	6.	7.
			UICC
okk		TX, N0, M0	X	X	X
0	Carcinoma in situ	Tis, N0, M0	X	X	X
0a			X	X	X
0is			X	X	X
I				X	X
IA		T1, N0, M0	X	X	X
IA1			X	X	X
IA2			X	X	X
IB		T2, N0, M0	X	X	X
IB1			X	X	X
IB2			X	X	X
IC			X	X	X
II			X	X	X
IIA		T1, N1, M0	X	X	X
IIA1					X
IIA2					X
IIB		T2, N1, M0	X	X	X
IIC		T3, N0, M0	X	X	X
III			X	X	X
IIIA		T1, N2, M0	X	X	X
IIIA		T2, N2, M0
IIIA		T3, N1,2, M0
IIIB		T4, each N, M0	X	X	X
IIIB		each T, N3, M0
IIIC			X	X	X
IS			X	X	X
IV		each T, each N, M1	X	X	X
IVA			X	X	X
IVB			X	X	X
IVC			X	X	X
not defined			X	X	X
not recommended				X	X

Table 24: Stage Classification ref. 18 Value Set (OID 1.2.276.0.76.11.5)

18 In: Schmoll HJ, Höffken K, Possinger K eds. Kompendium Internistische Onkologie. „Collection of Internistic Oncology “. Springer. 4. Edition; 2006

Venous Invasion

Code	Description	German
V0	no venous invasion	keine Veneninvasion
V1	microscopic venous invasion	mikroskopische Veneninvasion
V2	macroscopic venous invasion	makroskopische Veneninvasion
VX	venous invasion cannot be assessed	Veneninvasion nicht feststellbar

Table 25: Venous Invasion Code Value Set (OID 1.2.276.0.76.11.6)

Lymphatic System Invasion

Code	Description	German
L0	no lymphatic invasion	keine Lymphsysteminvasion
L1	lymphatic invasion	Lymphsysteminvasion
LX	lmphatic invasion cannot be assessed	Lymphsysteminvasion nicht fest­stellbar

Table 26: Lymphatic Invasion Codes Value Set (OID 1.2.276.0.76.11.7)

Perineural Invasion

Code	Description	German
Pn0	no perineural invasion	keine perineurale Invasion
Pn1	Perineural invasion	perineurale Invasion
PnX	unknown	Unbekannt

Table 27: Perineural Invasion Code Value Set (OID 1.2.276.0.76.11.8)

Qualifier

Code	Description	German
c	Assessment according to clinical criteria	Beurteilung nach klinischen Kriterien
p	according to the pathological results	nach dem pathologischen Befund
r	TNM result of recurrent tumor	TNM­Befund für Rezidivtumor
y	Classification of initial multimodal therapy	Klassifikation nach initialer multi­modaler Therapie

Table 28: TNM-Qualifier Value Set (OID 1.2.276.0.76.11.9)

Certainty

Code	Description of Evidence	German
C1	Evidence from standard diagnostic means (e.g., inspection, palpation, and standard radiography, intraluminal endoscopy for tumours of certain organs)	Nachweis durch diagnostische Standardmethoden (Inspektion, Palpation, einfache Röntgenaufnahmen)
C2	Evidence obtained by special diagnostic means (e.g., radiographic imaging in special projections, tomography, computerized tomography [CT], ultrasonography, lymphography, angiography,scintigraphy,magnetic resonance imaging [MRI],endoscopy, biopsy, and cytology)	Nachweis durch spezielle klinische diagnostische Methoden einschließlich Computertomogramm, Magnet­Resonanz­Tomographie
C3	Evidence from surgical exploration, including biopsy and cytology	Nachweis durch Operation, einschließlich Biopsie und Zytologie
C4	Evidence of the extent of disease following definitive surgery and pathological examination of the resected specimen	Nachweis durch operative Behandlung mit pathologischer Untersuchung der entnommenen Gewebeteile
C5	Evidence from autopsy	Nachweis durch Autopsie

Table 29: Certainty Factor Codes (OID 1.2.276.0.76.5.341)

Localisation of Distant Tumours / Metastases

Code	Description	German	Explanation
PUL	Pulmonary	Pulmonal	Lungenmetastase
OSS	Osseous	Ossär	Knochenmetastase
HEP	Hepatic	Hepatisch	Lebermetastase
BRA	Brain	Cerebral	Hirnmetastase
LYM	Lymph Nodes	Lymphonodulär	Lymphknotenmetastase
OTH	Others	Andere	Andere Metastase
MAR	Bone Marrow	Medullär	Knochenmarkmetastase
PLE	Pleura	Pleural	RippenfellMetastase
ADR	Adrenals	Adrenal	Nebennierenmetastase
SKI	Skin	dermal	Hautmetastase

Table 30: Metastases Localisation Codes (OID 1.2.276.0.76.5.401)

Codes for Gleason Score

The Gleason Grading system helps evaluating the prognosis of men with prostate cancer, as a part of a strategy of prostate cancer staging which predicts prognosis and guides therapy. The Gleason score is based on microscopic findings.

Code	Description	German
1	Round to oval equal individual glands, lying close to each other, sharply demarcated from the surrounding area	Runde bis ovale gleich große Einzeldrüsen, dicht nebeneinander liegend, scharf gegen die Umgebung abgegrenzt
2	Slightly less uniform single glands, separated by small amounts of stroma, less sharply defined tumor margin	Etwas weniger uniforme Einzeldrüsen, getrennt durch geringe Mengen von Stroma, weniger scharf begrenzter Tumorrand
3	a) Irregularly large and irregularly shaped glands, usually with abundant stroma, sometimes also stored tightly irregular and indistinct tumor border	Unregelmäßig große und unregelmäßig gestaltete Drüsen mit gewöhnlich reichlicherem Stroma, gelegentlich auch dicht gelagert, unregelmäßige und unscharfe Tumorgrenze
	b) Papillary or cribriform structures, sometimes in large gang­like formations	Papilläre oder kribriforme Strukturen, z.T. in großen gangähnlichen Bildungen
4	"a) Large irregular Epithelformationen by glandular fusion (""fused glands"") and branched glands with irregular infiltration into the surrounding area "	Große unregelmäßige Epithelformationen durch Drüsenverschmelzung („fused glands“) sowie verzweigte Drüsen mit unregelmäßiger Infiltration in die Umgebung
	b) Adenocarcinoma with prominent clear cytoplasm similar to clear cell adenocarcinomas of the kidney	Adenokarzinom mit ausgeprägt klarem Zytoplasma ähnlich hellzelligen Adenokarzinomen der Niere
5	a) Circumscribed round epithelial clusters with mostly solid and cribriform construction, usually with central necrosis	Scharf begrenzte runde Epithelhaufen mit meist solidem und kribriformem Bau, gewöhnlich mit zentraler Nekrose
	(comedo carcinoma­like)	(komedo­karzinomähnlich)
	b) Irregularly shaped formations of an undifferentiated carcinoma, which only just discernible glandular formation or is identified vacuoles (signet ring­like) than adenocarcinoma	Unregelmäßig begrenzte Formationen eines undifferenzierten Karzinoms, das nur durch gerade noch erkennbare Drüsenbildung oder Vakuolen (siegelringähnlich) als Adenokarzinom zu identifizieren ist

Table 31: Loss of Differentiation according to Gleason Score ref. 19 (OID 1.2.276.0.76.5.402)

Documentation by the GleasonSum (Gleason¬Score) as the sum of the two most dominating findings: Uniformly structured tumors: two times the points of above table. Non-uniformly structured tumors: points for the dominating share of findings (so-called primary grading) + points for second-largest share (secondary grading), if punch biopsy show more than two grades, the second component will be based on the most adverse component found.

19: Dt. Gesellschaft f. Urologie e.V.

Ann Arbor Codes

The tumor staging system for lymphomas.

Principal Stages

Code	Description
I	cancer is located in a single region, usually one lymph node and the surrounding area
II	cancer is located in two separate regions, an affected lymph node or organ and a second affected area, and that both affected areas are confined to one side of the diaphragm
III	cancer has spread to both sides of the diaphragm, including one organ or area near the lymph nodes or the spleen
IV	diffuse or disseminated involvement of one or more extralymphatic organs

Table 33: Ann Arbor (OID 1.2.276.0.76.5.405)

Modifiers for Constitutional Symptoms

Code	Description
A	absence of constitutional symptoms is denoted by adding an ""A""
B	presence of constitutional (B-type) symptoms is denoted by adding a ""B""

Table 34: Ann Arbor constitutional symptoms (OID 1.2.276.0.76.5.416)

Modifiers for Spread of Tumor

Code	Description
E	disease is ""extranodal"" (not in the lymph nodes) or has spread from lymph nodes to adjacent tissue.
S	the disease has spread to the spleen.
X	the largest deposit is >10 cm large (""bulky disease""), or the mediastinum is wider than 1/3 of the chest on a chest X-ray.

Table 35: Ann Arbor Extensions for Spreading in Organs Code Set (OID 1.2.276.0.76.5.417)

Papanicolaou Coding

Results of the so-called Pap-Test

Code	Meaning
Pap0	non representative sample
PapI	normal cell findings
PapII	atypical, benign disorder, infection, metaplasia, atrrophy, bacteria, viruses,
PapIIw	insufficient samples
PapIII	cell proliferation and atypic cells
PapIIID	dysplastic , mostly with HPV infection
PapIIIG	moderate/severe dyskaryosis and/or dysplasia
PapIV	biopsy sample and histological clarification required
PapIVa	carcinoma in situ
PapIVb	single certain tumour cells, carcinoma very certain
PapV	many certain tumour cells, carcinoma certain, cellular changes suggestive of invasive squamous carcinoma, and cellular changes indicative of adenocarcinoma of the uterine cervix and other invasive cancer.

Table 36: Grading according to Papanicolaou (OID 1.2.276.0.76.5.406)