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§170.315(b)(2) Clinical information reconciliation and incorporation

Version 1.3 Updated on 09-29-2017
Revision History
Version # Description of Change Version Date
1.0

Final Test Procedure

01-20-2016
1.1

Updated paragraph (b)(2)(iii)(A) under TLV to remove ordered, prescribed, refilled, dispensed from last medication bullet.

08-01-2016
1.2

Addition of statement – reconciliation process must be completed in a simultaneous view.

07-07-2017
1.3

Clarified paragraph (b)(2)(iii)(B) TLV requirements for displaying and reconciling a list for each list type.

09-29-2017
Regulation Text
Regulation Text

§170.315 (b)(2) Clinical information reconciliation and incorporation

  1. General requirements. Paragraphs (b)(2)(ii) and (iii) of this section must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) using the Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary document templates.
  2. Correct patient. Upon receipt of a transition of care/referral summary formatted according to the standards adopted §170.205(a)(3) and §170.205(a)(4), technology must be able to demonstrate that the transition of care/referral summary received can be properly matched to the correct patient.
  3. Reconciliation. Enable a user to reconcile the data that represent a patient's active medication list, medication allergy list, and problem list as follows. For each list type:
    1. Simultaneously display (i.e., in a single view) the data from at least two sources in a manner that allows a user to view the data and their attributes, which must include, at a minimum, the source and last modification date.
    2. Enable a user to create a single reconciled list of each of the following: Medications; medication allergies; and problems.
    3. Enable a user to review and validate the accuracy of a final set of data.
    4. Upon a user's confirmation, automatically update the list, and incorporate the following data expressed according to the specified standard(s):
      1. Medications. At a minimum, the version of the standard specified in §170.207(d)(3);
      2. Medication allergies. At a minimum, the version of the standard specified in §170.207(d)(3); and
      3. Problems. At a minimum, the version of the standard specified in §170.207(a)(4).
  4. System verification. Based on the data reconciled and incorporated, the technology must be able to create a file formatted according to the standard specified in §170.205(a)(4) using the Continuity of Care Document document template.
Standard(s) Referenced

Please consult the Final Rule 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 certification criterion with which these testing steps are associated. We also encourage developers to consult the Certification Companion Guide in tandem with the test procedure as they provide clarifications that may be useful for product development and testing.

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.

 

Testing components

No GAP Icon No Documentation Icon Visual Inspection Icon Test Tool Icon ONC Supplied Test Data Icon

 

Paragraph (b)(2)(i)

Paragraphs (b)(2)(ii) and (iii) of this section must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standards adopted in § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 and § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1 using the Continuity of Care Document (CCD), Referral Note, and (inpatient setting only) Discharge Summary document templates.

 

Paragraph (b)(2)(ii)

System Under Test Test Lab Verification

Setup

  1. Using the ETT: Message Validators – C-CDA R2.1 Validator, the user selects the receiver “170.315_b2_CIRI_Amb ” or “170.315_b2_CIRI_Inp” criteria, selects one of the C-CDA R2 Release 2.1 xml files, and executes the download of the required Clinical Information Reconciliation document 170.315_b2_ciri_r21_sample*.xml file for C-CDA R2 Release 2.1.
  2. The user repeats step 1, but selects the corresponding CDA R2 Release 1.1 xml file from the File Name and executes the download of the required Clinical Information Reconciliation document 170.315_b2_ciri_r11_sample*.xml file for C-CDA R2 Release 1.1.

Correct Patient

  1. Using the xml files downloaded in steps 1 and 2, the user demonstrates that a transition of care summary/referral summary Consolidated-Clinical Document Architecture (C-CDA) document, formatted according to the standard adopted at § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1, and a transition of care summary/referral summary C-CDA document, formatted according to the standard adopted at § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, can be properly matched to a patient in the Health IT Module. Note that matches can be made automatically or manually.
  2. The user repeats steps 1-3 for each set of C-CDA R2 Release 1.1 and C-CDA R2 Release 2.1 xml files listed in the File Name for each of the health IT settings being certified.

Setup

  1. The tester creates a human readable version of the downloaded C-CDA R2 Release 2.1 and C-CDA R2 Release 1.1 files from step 1 of the SUT to be used for verification.

Correct Patient

  1. The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 1 of the SUT as a C-CDA Release 1.1 document formatted according to the standard specified in § 170.205(a)(3) as either a CCD or a C-CDA with no specific document template.
  2. The tester uses visual inspection to verify the Health IT Module can receive the C-CDA document downloaded in step 2 of the SUT as a C-CDA Release 2.1 documents formatted according to the standard specified in § 170.205(a)(4) using one of the following document templates:
    • Continuity of Care Document (CCD);
    • Referral Note; and
    • Inpatient setting only: Discharge Summary.
  3. Using the Health IT Module and the human readable xml files from step 1, the tester verifies that the received C-CDA Release 1.1 and Release 2.1 documents can be properly matched to the correct patient record.

Paragraph (b)(2)(iii)(A)

System Under Test Test Lab Verification

Simultaneous Display

  1. Using the ETT: Message Validators – C-CDA R2.1 Validator, the user downloads the Clinical Information Reconciliation documents (xml) by selecting the receiver “170.315_b2_CIRI_Amb” or “170.315_b2_CIRI_Inp” criteria and the required Clinical Information Reconciliation documents xml files for both C-CDA Release 1.1 and Release 2.1 and executes the download.
  2. The user simultaneously views data (including active medications, medication allergies, and problems) along with the source and last modification date attributes from at least two sources:
    • The current patient record which includes the base input received in section (b)(2)(ii); and
    • The Transition of care summary/referral summary C-CDA Release 1.1 and Release 2.1 document, formatted according to the standard adopted at § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 AND § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1 which includes the reconciliation data 170.315_b2_ciri_r11_ sample*_recon*.xml or 170.315_b2_ciri_r21_ sample*_recon*.xml.

Note that Health IT Module will need to separately demonstrate the ability to reconcile summary of care documents formatted according to § 170.205(a)(3) HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 and § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, and they will need to separately demonstrate each of the following document templates: CCD or C-CDA with no specific document template for C-CDA Release 1.1; and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA Release 2.1 for the health IT setting(s) being certified.

Simultaneous Display

  1. The tester verifies that data from multiple sources can be simultaneously displayed in a single view for medications, medication allergies, and problems, including both the source and last modification date. The last modification date is defined for each list as:
    • Last date medication was documented, or edited;
    • Last date the problem was documented or edited; and
    • Last date the medication allergy was documented or edited.

Further, the tester must verify that the Health IT Module can display the current patient record and a transition of care summary/referral summary C-CDA Release 1.1 and Release 2.1 document, formatted according to the standard adopted at § 170.205(a)(3) and separately the current patient record and a transition of care summary/referral summary C-CDA document, formatted according to the standard adopted at § 170.205(a)(4). 

The tester must verify that this can be completed for the CCD or C-CDA with no specific document template for C-CDA Release 1.1; and CCD, Referral Note, and (inpatient setting only) Discharge Summary document templates for C-CDA Release 2.1.


Paragraph (b)(2)(iii)(B)

System Under Test Test Lab Verification

The user creates a single, reconciled list using the data reviewed from the multiple medications, problems, or medication allergies list sources in step one for each of the following:

  • Medications;
  • Medication allergies; and
  • Problems.

The tester verifies that, for each list type: a simultaneous display (i.e. a single view), duplicates can be consolidated into a single representation, list items can be removed, and any other methods the Health IT Module may use to reconcile the list. The entire reconciliation process must occur within a simultaneous view.


Paragraph (b)(2)(iii)(C)

System Under Test Test Lab Verification

The user reviews the details of the reconciled list and validates its accuracy.

The tester verifies that, for each list type, a user is able to review and verify the accuracy of the final list.


Paragraph (b)(2)(iii)(D)

System Under Test Test Lab Verification

The user accepts the reconciled list and the patient record in the Health IT Module is updated.

The tester verifies that reconciled medications, medication allergies, and problems data are accurately incorporated into the patient record and expressed in the following:

  • Medications are expressed according to the standard specified in § 170.207(d)(3) RxNorm;
  • Medication allergies are expressed according to the standard specified in § 170.207(d)(3); and
  • Problems are expressed according to the standard specified in § 170.207(a)(4) SNOMED CT®.

Paragraph (b)(2)(iv)

System Under Test Test Lab Verification
  1. For each reconciliation in (b)(2)(iii), a user creates a CCD that includes the reconciled and incorporated data, in accordance with the standard adopted at § 170.205(a)(4) HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, DSTU Release 2.1, for each of the following:
    • Medications;
    • Medication allergies; and
    • Problems.
  1. Using the reconciled CCD document submitted by the SUT, the tester uses the ETT: Message Validators –C-CDA R2.1 Validator to upload the submitted CCD by selecting the sender “170.315_b2_CIRI_Amb” or “170.315_b2_CIRI_Inp” criteria, and the file name corresponding to the reconciliation input samples. The tester executes the upload.
  2. The tester uses the ETT: Message Validators Validation Report created as a result of the upload in step 1 to verify the Health IT Module passes without error to confirm that the Clinical Information Reconciliation CCD document is conformant when it is created after a reconciliation of medications, medication allergies, and/or problems has been performed. Furthermore, the tester verifies that it meets the standard specified in § 170.205(a)(4). This verification is only for C-CDA Release 2.1 CCD documents.

Version 1.4 Updated on 09-21-2018
Revision History
Version # Description of Change Version Date
1.0

Initial Publication

10-29-2015
1.1

Added the links to the test tool and test tool user guide.

01-29-2016
1.2

Provides notification of March 2017 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.

09-29-2017
1.3

Provides notification of April 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion. Note: Due to an error in calculation ONC is also updating the dates for compliance with the March 2017 Validator Update of C-CDA 2.1 Corrections that were adopted September 29, 2017.

05-02-2018
1.4

Provides notification of August 2018 Validator Update of C-CDA 2.1 Corrections adoption and compliance requirements for the entire criterion.

09-21-2018
Regulation Text
Regulation Text

§170.315 (b)(2) Clinical information reconciliation and incorporation

  1. General requirements. Paragraphs (b)(2)(ii) and (iii) of this section must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) using the Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary document templates.
  2. Correct patient. Upon receipt of a transition of care/referral summary formatted according to the standards adopted §170.205(a)(3) and §170.205(a)(4), technology must be able to demonstrate that the transition of care/referral summary received can be properly matched to the correct patient.
  3. Reconciliation. Enable a user to reconcile the data that represent a patient's active medication list, medication allergy list, and problem list as follows. For each list type:
    1. Simultaneously display (i.e., in a single view) the data from at least two sources in a manner that allows a user to view the data and their attributes, which must include, at a minimum, the source and last modification date.
    2. Enable a user to create a single reconciled list of each of the following: Medications; medication allergies; and problems.
    3. Enable a user to review and validate the accuracy of a final set of data.
    4. Upon a user's confirmation, automatically update the list, and incorporate the following data expressed according to the specified standard(s):
      1. Medications. At a minimum, the version of the standard specified in §170.207(d)(3);
      2. Medication allergies. At a minimum, the version of the standard specified in §170.207(d)(3); and
      3. Problems. At a minimum, the version of the standard specified in §170.207(a)(4).
  4. System verification. Based on the data reconciled and incorporated, the technology must be able to create a file formatted according to the standard specified in §170.205(a)(4) using the Continuity of Care Document document template.
Standard(s) Referenced

Certification Companion Guide: Clinical information reconciliation and incorporation

This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product development. The CCG is not a substitute for the 2015 Edition final regulation. It extracts key portions of the rule’s preamble and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the 2015 Edition final rule or other included regulatory reference. The CCG is for public use and should not be sold or redistributed.
 

 

Certification Requirements

Privacy and Security: This certification criterion was adopted at § 170.315(b)(2). As a result, an ONC-ACB must ensure that a product presented for certification to a § 170.315(b) “paragraph (b)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.

  • The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (b) criterion unless it is the only criterion for which certification is requested.
  • As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, exceptions exist for § 170.315(e)(1) “VDT” and (e)(2) “secure messaging,” which are explicitly stated.

Design and Performance: The following design and performance certification criteria (adopted in § 170.315(g)) must also be certified in order for the product to be certified.

  • Safety-enhanced design (§ 170.315(g)(3)) must be explicitly demonstrated for this criterion.
  • When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, the QMS’ need to be identified for every capability to which it was applied.
  • When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively the developer must state that no accessibility-centered design was used.
  • C-CDA creation performance (§ 170.315(g)(6)) does not need to be explicitly tested with this criterion unless it is the only criterion within the scope of the requested certification that includes C-CDA creation capabilities. Note that the application of § 170.315(g)(6) depends on the C-CDA templates explicitly required by the C-CDA-referenced criterion or criteria included within the scope of the certificate sought. Please refer to the C-CDA creation performance Certification Companion Guide for more details.
Table for Privacy and Security
Technical Explanations and Clarifications

 

Applies to entire criterion

Clarifications:

  • The scope of this criterion is limited to the Consolidated CDA (C-CDA) Continuity of Care Document (CCD), Referral Note, and (inpatient setting only) Discharge Summary document templates. [see also 80 FR 62639]
  • “Incorporation” means to electronically process structured information from another source such that it is combined (in structured form) with information maintained by health IT and is subsequently available for use within the health IT system by a user. [see also 77 FR 54168 and 77 FR 54218]
  • In order to mitigate potential interoperability errors and inconsistent implementation of the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, Draft Standard for Trial Use, Release 2.1, ONC assesses, approves, and incorporates corrections as part of required testing and certification to this criterion. [see FAQ #51] Certified health IT adoption and compliance with the following corrections are necessary because they implement updates to vocabularies, update rules for cardinality and conformance statements, and promote proper exchange of C-CDA documents. Consistent with FAQ 51, there is a 90-day delay from the time the CCG has been updated with the ONC-approved corrections to when compliance with the corrections will be required to pass testing (i.e., C-CDA 2.1 Validator). Similarly consistent with FAQ 51, there will be an 18-month delay before a finding of a correction’s absence in certified health IT during surveillance would constitute a non-conformity under the Program.

Paragraph (b)(2)(i)

Clarifications:

  • We are requiring Health IT Modules to be able to reconcile and incorporate information from C-CDAs formatted to both C-CDA Releases 1.1 and 2.1. While Release 2.1 largely ensures compatibility between C-CDA Release 1.1 and 2.0, it does not guarantee compatibility without further development effort. [see also 80 FR 62639]

Paragraph (b)(2)(ii)

Technical outcome – The health IT can properly match a received transition of care (ToC)/referral summary (for both Releases 1.1 and 2.1) to the correct patient.

Clarifications:

  • Health IT Modules do not have to auto-match the patient. Manual patient match is acceptable as long as the received C-CDA can be matched to the correct patient. [see also 80 FR 62640 and 77 FR 54219]

Paragraph (b)(2)(iii)(A)

Technical outcome – A user can simultaneously display a patient’s active data and the data attributes from two sources, for each of a patient’s medication list, medication allergy list, and problem list. The data display must include the source and the last modification date.

Clarifications:

  • A vendor must enable a user to electronically and simultaneously display (that is in a single view) the data from at least two list sources. If the two lists cannot be displayed in the tool at the same time this does not constitute a single view and does not meet the requirements for the certification criterion.

Paragraphs (b)(2)(iii)(B) - (D)

Technical outcome – A user can review, validate, and incorporate a patient’s medication list (using RxNorm), medication allergy list (using RxNorm), and problem list (using SNOMED CT®).

Clarifications:

  • The health IT can enable a user to review, validate, and incorporate medications, medication allergies, and problems in distinct functions, or combined, as long as all three can be demonstrated. [see also 80 FR 62639]
  • Testing will evaluate health IT ability to incorporate data from C-CDA documents with variations in the data elements to be reconciled to test real-world variation that may be found in C-CDA documents. [see also 80 FR 62639]
  • ONC encourages developers to incorporate data in a structured format. [see also 77 FR 54219]
  • Incorporation does not have to be automated. [see also 77 FR 54219]
  • Health IT Modules can present for certification to a more recent version of RxNorm than the September 8, 2015 Release per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]
  • Health IT Modules can present for certification to a more recent version of SNOMED CT®, U.S. Edition than the September 2015 Release per ONC’s policy that permits certification to a more recent version of certain vocabulary standards. [see also 80 FR 62620]
  • We provide the following OIDs to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
    • RxNorm OID: 2.16.840.1.113883.6.88.
    • SNOMED CT® OID: 2.16.840.1.113883.6.96. [see also 80 FR 62612]

Paragraph (b)(2)(iv)

Technical outcome – The health IT can create a C-CDA document (using the CCD template in C-CDA Release 2.1) that includes the reconciled and incorporated data.

Clarifications:

  • No additional clarifications available.

Regulation Text
Regulation Text

§170.315 (b)(2) Clinical information reconciliation and incorporation

  1. General requirements. Paragraphs (b)(2)(ii) and (iii) of this section must be completed based on the receipt of a transition of care/referral summary formatted in accordance with the standards adopted in §170.205(a)(3) and §170.205(a)(4) using the Continuity of Care Document, Referral Note, and (inpatient setting only) Discharge Summary document templates.
  2. Correct patient. Upon receipt of a transition of care/referral summary formatted according to the standards adopted §170.205(a)(3) and §170.205(a)(4), technology must be able to demonstrate that the transition of care/referral summary received can be properly matched to the correct patient.
  3. Reconciliation. Enable a user to reconcile the data that represent a patient's active medication list, medication allergy list, and problem list as follows. For each list type:
    1. Simultaneously display (i.e., in a single view) the data from at least two sources in a manner that allows a user to view the data and their attributes, which must include, at a minimum, the source and last modification date.
    2. Enable a user to create a single reconciled list of each of the following: Medications; medication allergies; and problems.
    3. Enable a user to review and validate the accuracy of a final set of data.
    4. Upon a user's confirmation, automatically update the list, and incorporate the following data expressed according to the specified standard(s):
      1. Medications. At a minimum, the version of the standard specified in §170.207(d)(3);
      2. Medication allergies. At a minimum, the version of the standard specified in §170.207(d)(3); and
      3. Problems. At a minimum, the version of the standard specified in §170.207(a)(4).
  4. System verification. Based on the data reconciled and incorporated, the technology must be able to create a file formatted according to the standard specified in §170.205(a)(4) using the Continuity of Care Document document template.
Testing Tool

Edge Testing Tool (ETT): Message Validators

 

Test Tool Documentation

Test Tool Supplemental Guide

 

Criterion Subparagraph Test Data
(b)(2)(ii)

170.315_b2_ciri_r11_sample*.xml (All Samples)

170.315_b2_ciri_r21_sample*.xml (All Samples)

(b)(2)(iii)

170.315_b2_ciri_r11_sample*.xml (All Samples)

170.315_b2_ciri_r11_ sample*_recon*.xml (All Samples)

170.315_b2_ciri_r21_sample*.xml (All Samples)

170.315_b2_ciri_r21_sample*_recon*.xml (All Samples)

Content last reviewed on September 24, 2018
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