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. 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.
Note that Section 1.1 Item 3 is optional, depending on which edge protocol the Health IT Module chooses for certification.
1.1 Send and Receive Transitions of Care Documents via Edge Protocol
Evaluate the Health IT Module’s ability to send and receive transitions of care/referral summaries through a method
that conforms to the Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014 and optionally,
receive and make available the contents of an XDM packaged formatted in accordance with IHE IT Infrastructure
Technical Framework Volume 2b.
Item #
1
Technical Outcome
Test Lab Verification
Test Approach
A summary of care is transmitted to a
third party via one of the following
required edge protocols specified in the
standard at §170.202(d):
• IHE XDR or
• SMTP.
The tester verifies that the Health IT Module
can transmit (send) the health information to
a third party using one of the edge protocols
specified in the standard at §170.202(d).
Edge Testing Tool
and visual
inspection.
Optionally, Health IT Modules may also
be certified to one of the following
optional edge protocols specified in the
standard at §170.202(d):
• IMAP4 or
• POP3.
1
Item #
2
3
Technical Outcome
Test Lab Verification
Test Approach
A transitions of care/referral summary is
received via one of the edge protocols
specified in the standard at §170.202(d)
from a third party that has implemented
the DIRECT: Applicability Statement for
Secure Health Transport, Version 1.1,
July 10, 2012.
The tester verifies that the Health IT Module
receives the health information through a
method that conforms to one of the edge
protocols specified in the standard at
§170.202(d) from a third party that has
implemented the standard specified at
§170.202(a).
Edge Testing Tool
and visual
inspection.
Transitions of care summaries received
from a third party that is using XDM
packaging (that has been formatted in
accordance with the standard specified
at §170.205(p)(1)) can be viewed and
incorporated by a user.
The tester verifies that the Health IT Module
utilizing the SMTP edge protocol can receive
health information from a third party that has
been packaged in accordance with the
standard specified at §170.205(p)(1)) and
make the contents available to a user.
Edge Testing Tool
and visual
inspection.
1.2 Validate and Display Transitions of Care Documents
Evaluate the Health IT Module’s ability to parse, detect errors, identify as valid and invalid, correctly interpret
sections, record errors, and display in human readable format transitions of care/referral summaries received and
formatted in accordance with both 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 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)).
2
Item #
1
Technical Outcome
Test Lab Verifications
Test Approach
When a C-CDA formatted in accordance with
the standards specified at §170.205(a)(3) or
§170.205(a)(4) is received, it is handled in the
following ways:
• CCD, Consultation Note, History and
Physical, Progress Note, Care Plan,
Transfer Summary, Referral Note, and
Discharge Summary document templates
are parsed;
• Errors in the document templates,
section templates, and entry templates,
including the use of vocabulary codes
that are not specified in either
implementation guide or that don’t exist
in the value set, are detected, recorded,
and users are notified of the errors so
they can review them;
• Valid document templates are processed,
meaning that the data elements included
in the section and entry templates are
handled; and
• Any empty sections and null
combinations are correctly interpreted.
The tester verifies that the Health IT
Module can parse the document type
correctly, according to one of the
following document templates:
Test data (multiple
C-CDA documents
with valid and
invalid data) and
visual inspection.
•
•
•
•
•
•
•
•
CCD
Consultation Note
History and Physical
Progress Note
Care Plan
Transfer Summary
Referral Note
Discharge Summary
The tester verifies that the Health IT
Module correctly identifies invalid C-CDA
documents. This includes:
• Document templates
• Required sections
• Required entries
• Vocabulary standards and codes not
specified in § 170.205(a)(3) and §
170.205(a)(4).
The tester verifies that the Health IT
Module correctly identifies valid C-CDA
documents and processes the required
data elements for required sections and
entries, as specified in §170.205(a)(3) and
§170.205(a)(4).
The tester verifies the ability of the Health
IT Module to track errors in received CCDAs and provide users with a mechanism
to review them.
2
A user can view and read a transitions of
care/referral summary received from a third
party within their Health IT Module.
The tester verifies that the displayed CCDA transitions of care /referral
documents are accurate and complete,
for documents received that are
formatted in accordance with the
standards specified in § 170.205(a)(3) and
§ 170.205(a)(4).
Test data and
visual inspection.
3
Item #
3
Technical Outcome
Test Lab Verifications
Test Approach
A user can view an individual section of a
transitions of care/referral summary and its
header information received from a third
party within their Health IT Module.
The tester verifies the ability of the Health
IT Module to display the document
header information and each of the
individual document sections (individually
or together), for documents received that
are formatted in accordance with
appropriate standards as specified in
§170.205(a)(3) and §170.205(a)(4).
Test data and
visual inspection.
1.3 Create Transitions of Care Documents
Evaluate the Health IT Module’s ability to electronically create transition of care/referral summaries, care plan
documents, referral notes or transfer summaries, which include the minimum CCDS includes the following data where
applicable.
4
Item #
1
Technical Outcome
Test Lab Verification
Test Approach
A user creates a transition of care/referral summary
for a specific patient that is formatted according to the
standards adopted in §170.205(a)(3) and
§170.205(a)(4) and includes the following data, when
such data is available in the patient record:
• Common Clinical Data Set;
• Encounter diagnoses in the standard specified at
§170.207(i) or at a minimum the version of the
standard specified at §170.205(a)(4);
• Cognitive status;
• Functional Status;
• For ambulatory settings only: reason for referral,
referring or transitioning provider’s name, and
office contact information;
• For inpatient settings only: discharge instructions;
and
• The following patient demographics:
o First name
o Last or family name according to the CAQH
Phase II Core 258: Eligibility and Benefits
270/271 Normalizing Patient Last Name Rule
version 2.1.0;
o Maiden name;
o Middle name (including middle initial);
o Suffix the CAQH Phase II Core 258: Eligibility
and Benefits 270/271 Normalizing Patient
Last Name Rule version 2.1.0 (includes JR, SR,
I,II, III, IV, V, RN, MD, PHD, and ESQ), and use
a null value if no suffix exists;
o Date of birth, including year, month, and day
and if present hour, minute, and second (if
hour, minute, and second are included either
time zone offset is included or place of birth)
and use a null value if date of birth is
unknown;
o Current address;
o Historical address;
o All phone numbers present in the ITU format
specified in ITU-T E.123 and ITU-T E.164; and
o Sex in the standard adopted at
§170.207(n)(1).
The tester verifies that the Health
IT Module can create a transitions
of care/referral summary
document formatted according to
the standards specified in
§170.205(a)(3) and
§170.205(a)(4), and including at a
minimum CCDS and data
requirements specified in the
technical outcome.
Test data,
visual
inspection, and
the C-CDA
validator within
the Edge Testing
Tool.
The tester should utilize the C-CDA
validator tool within the Edge
Testing Tool to test C-CDA
documents’ conformance to both
§170.205(a)(3) and
§170.205(a)(4).
The tester should further utilize
visual inspection to:
•
•
Verify that coded values are
within the specified value set
for the standard at
§170.205(a)(3) and
§170.205(a)(4) and are
accurate
Compare values within the
Health IT Module and the
created C-CDA to verify that
the values are accurate and
contained in the correct C-CDA
section.
5
2. Document History
Version Number
Description of Change
Date
1.0
Released for Public Comment
March 31, 2015
3. Dependencies
For the related and required criteria, please refer to the Master Table of Related and Required Criteria.
6