This element SHALL be present and is valued from the RealmOfUse [2.16.840.1.113883.1.11.11050] subset, within the VocabularyDomainQualifier value set. In the international context of this profile used as it is without any further extension, the realm code SHALL be <realmCode code="UV"/> (universal).

Whenever a national extension has been defined and is used, the realm code SHALL identify this national extension.

This element is a technology-neutral explicit reference to the standard CDA R2. It SHALL be present and valued as follows:
ClinicalDocument/typeId@root = "2.16.840.1.113883.1.3" (which is the OID for HL7 Registered models);
ClinicalDocument.typeId@extension = "POCD_HD000040" (which is the unique identifier for the CDA, Release Two Hierarchical Description).

This element is identifying the set of constraints applied to the CDA R2 standard by this IHE specification of a laboratory report. The following templateId SHALL be present and valued as follows to indicate compliance with the XD-LAB specification.

ClinicalDocument/Id SHALL be present. It represents the unique instance identifier of the clinical document. The combination of the root and extension attributes SHALL provide a globally unique identifier, in accordance with CDA R2, without further constraints.

ClinicalDocument/code SHALL be present. The laboratory report can be either a multi-disciplinary report or a single discipline report.

Multi-disciplinary Laboratory Report:
The LOINC code identifying the type of document as a (potentially) multidisciplinary laboratory report (presenting results from many specialties) is:
<code codeSystem="2.16.840.1.113883.6.1" codeSystemName=”LOINC” code="11502-2" displayName="LABORATORY REPORT.TOTAL"/>

Single Discipline Laboratory Report:
Use the appropriate LOINC code as listed in Value-Set “Laboratory Specialties”.

The Laboratory Specialty Section <title> MAY be present. It is the local translation of the code@displayName.

ClinicalDocument/effectiveTime SHALL be present. It contains the creation date & time of the laboratory report as an electronic document. In case this is a new revision replacing a previous version (identified in parentDocument), this is the date & time of the new revision.

ClinicalDocument/confidentialityCode SHALL be present in accordance with the HL7 CDA R2 standard.

ClinicalDocument/languageCode SHALL be present in accordance with the HL7 CDA R2 standard.

ClinicalDocument/setId SHALL be present to enable further updates of the clinical document. It is an identifier that is common across all revisions of this laboratory report.

ClinicalDocument/versionNumber MAY be present. As requested by the CDA standard, it is an integer value used as versioning.

The author/time element carries the date&time the laboratory report was produced.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

ClinicalDocument/author SHALL be present in accordance with the HL7 CDA R2 standard

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

ClinicalDocument/custodian SHALL be present with an id in accordance with the HL7 CDA R2 standard.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

The sub-element time carries the date&time this legal authentication took place.

The sub-element signatureCode carries the “signed” (S) status

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

Constrained by this specification to require the presence of name, addr and telecom.

Constrained by this specification to require the presence of name, addr and telecom.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

All persons (including the patient) and organizations mentioned in the document SHALL provide elements name, addr and telecom.

The ClinicalDocument/authenticator element MAY be present. When present it represents the clinical expert who performed the clinical validation (see the entries “validator” and “clinical expert” in the glossary in LAB TF-1:1.11) of the report or of a subset of its results, also called the validator.

This element SHALL be in accordance with the HL7 CDA R2 standard and further constrained by this specification to require the presence of name, addr and telecom.

There MAY be more than one validator of the report. All the validators SHALL appear in the report header as authenticator elements AND, in the case of multiple validators, each individual validator SHALL be associated with the particular sections of the report he or she validated. In this case, the validator of a section SHALL also appear in the entry this section is derived from.

This module is consistent with the CDA standard regarding participant and requires in addition the name, addr and telecom for all participants.

It represents the Placer Order or the Placer Group that was fulfilled, the id of which is carried by inFulfillmentOf/order/id.

Use of sub element documentationOf/serviceEvent/effectiveTime to document the time boundaries of events in the document is appropriate.

This Laboratory Report Content Module can express both final and non-final reports. To distinguish between the two, the statusCode element has been added to the documentationOf/serviceEvent element. A non-final report is a report documenting a serviceEvent, which is in the status "active". This sub-element serviceEvent/statusCode is optional. When it is not present the serviceEvent is assumed to be in the status "completed".

Laboratory Performer template in the CDA header

relatedDocument@typeCode attribute SHALL be valued "RPLC".

SHALL be equal to ClinicalDocument/ id of the replaced document.

SHALL have the same value in the new report as in the replaced report.

SHALL have the same value as in the replaced report (when provided there)

Content Modules for CDA Sections (Level 2)

A laboratory report SHALL have a structuredBody. This body is organized as a tree of up to two levels of sections, delivering the human-readable content of the report: Top level sections represent laboratory specialties. A top level section SHALL contain either one text block carrying all the text results produced for this specialty along with a single Laboratory Data Processing Entry or a set of Laboratory Report Item Sections. In the first case the specialty section happens to also be a leaf section. In the latter case, each (second level) leaf section contained in the (top level) specialty section represents a Report Item: i.e., a battery, a specimen study (especially in microbiology), or an individual test. In addition, any leaf section SHALL contain a single Laboratory Data Processing Entry containing the observations of that section in a machine-readable format.