1. No category

Please consult the Notice of Proposed Rulemaking (NPRM) entitled: 2015 Edition Health Information Technology (Health
IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification
Program Modifications for a detailed description of the proposed certification criterion with which these testing steps
are associated.
1. Description
This certification criterion rigorously assesses a product’s ability to create Consolidated CDA (C-CDA) Documents for both
the 2014 and 2015 NPRM Editions. This certification criterion is not stand-alone, and must be used in-conjunction with a
criterion which expresses the capability of creating C-CDA documents (e.g. Transitions of care, Data Portability); however,
if multiple C-CDA creation certifications are sought, this certification criterion only needs to be tested once. Additionally,
the capabilities described can be demonstrated in tandem and do not need to be individually addressed in isolation or
sequentially.
Upon positive completion of the certification, the C-CDA files created under test must be retained and contributed to the
ONC-maintained repository.
2. Required Tests
Note: The order in which the test steps are listed reflects the sequence of the certification criterion and does not necessarily
prescribe the order in which the test should take place.
2.1 Reference C-CDA Match
Evaluate the capability of the Health IT Module to create both C-CDA Release 1.1 in accordance with the HL7
Implementation Guide for CDA® Release 1.1: Consolidated CDA Templates for Clinical Notes (US Realm), Draft
Standard for Trial Use, Release 1.1 (C-CDA (Draft Standard for Trial Use, Release 1.1)), including the Common Clinical
Data Set (CCDS) requirements AND C-CDA Release 2.0 documents in accordance with the HL7 Implementation Guide
for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Release
2.0 (C-CDA (Draft Standard for Trial Use, Release 2.0)) including Common Clinical Data Set (CCDS) requirements, which
match the ONC gold standard Reference C-CDA.
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Item # Technical Outcome
A C-CDA Release 1.1 document in
1a
accordance with § 170.205(a)(3),
which includes all of the Common
Clinical Data Set (CCDS) data
elements is created by a user.
1b
A C-CDA Release 2.0 document in
accordance with § 170.205(a)(4),
which includes all of the CCDS
data elements is created by a
user.
Test Lab Verification
Test Approach
The tester verifies that the created
C-CDA document matches the gold
standard Reference C-CDA which
conforms to C-CDA (Draft Standard
for Trial Use, Release 1.1) and
includes the CCDS data element
requirements.
At a minimum, the Health IT
Module must consume test data,
create a C-CDA, and pass the CCDA through a test tool.
The tester verifies that the created
C-CDA document matches the gold
standard Reference C-CDA which
conforms to C-CDA (Draft Standard
for Trial Use, Release 2.0) and
includes the CCDS data element
requirements.
At a minimum, the Health IT
Module must consume test data,
create a C-CDA, and pass the CCDA through a test tool.
2.2 Document Template, Vocabulary, and Value Set Conformance
Evaluate the capability of the Health IT Module to create both C-CDA Release 1.1 and Release 2.0 documents which
conform to specified Templates, vocabularies, and value sets in the HL7 Implementation Guide for CDA® Release 1.1:
Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Release 1.1 (C-CDA (Draft
Standard for Trial Use, Release 1.1)) and HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates
for Clinical Notes (US Realm), Draft Standard for Trial Use, Release 2.0 (C-CDA (Draft Standard for Trial Use, Release
2.0)) respectively.
Item # Technical Outcome
The following C-CDA Release 1.1
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documents are created:
• Continuity of Care Document
(CCD)
• Consultation Note
• History and Physical
• Progress Note
• Transfer Summary
• Discharge Summary (for
inpatient setting only)
For CCDS data elements, the Health IT
Module creates documents that comply
with required vocabulary standards (and
value sets).
Test Lab Verification
Test Approach
The tester verifies that the C-CDA
Release 1.1 documents can be
created, and that each document
type conforms to the C-CDA (Draft
Standard for Trial Use, Release 1.1)
standard templates which have been
further constrained by the CCDS.
Additionally the tester verifies the
Vocabularies and values sets used in
the xml file have been properly
implemented for CCDS data elements.
C-CDA Tool (document
type conformance) and
test data (health
information). Visual
inspection where
necessary.
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Item # Technical Outcome
The following C-CDA Release 2.0
2
documents are created:
• Continuity of Care Document
(CCD)
• Consultation Note
• History and Physical
• Progress Note
• Care Plan
• Transfer Summary
• Referral Note
• Discharge Summary (for
inpatient setting only).
For CCDS data elements, the Health IT
Module creates documents that comply
with required vocabulary standards (and
value sets).
Test Lab Verification
Test Approach
Tester verifies that the C-CDA Release
2.0 documents can be created, and
that each document type conforms to
the C-CDA (Draft Standard for Trial
Use, Release 2.0) standard templates
which have been further constrained
by the CCDS.
Additionally the tester verifies the
Vocabularies and values sets used in
the xml file have been properly
implemented for CCDS data elements.
C-CDA Tool (document
type conformance) and
test data (health
information). Visual
inspection where
necessary.
3. Document History
Version Number
Description of Change
Date
1.0
Released for Public Comment
March 31, 2015
4. Dependencies
For the related and required criteria, please refer to the Master Table of Related and Required Criteria.
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