1 healthcare information technology standards panel care delivery - is01 electronic health record...

1Healthcare Information Technology Standards Panel

Healthcare Information Technology Standards Panel

Care Delivery - IS01 Electronic Health Record (EHR) Laboratory Results Reporting

July 6, 2007


Electronic Health Record (EHR) Laboratory Results Reporting

Scope– Deploy standardized, widely available, secure solutions for accessing

laboratory results and interpretations in a patient-centric manner for clinical care by authorized parties

IS addresses lack of harmonization among data interoperability standards including vocabulary and laboratory and other messaging standards– IS accommodates both laboratory message transaction and document

sharing paradigms– IS selects standards with wide coverage to address gaps and provide

mapping between standards to address overlaps

HL7 and HITSP Lab WG are coordinating activities to complete a lab message implementation guide to meet the use case requirements. The guide is now being balloted by HL7.


A. Identify/create lab result terminology

B. Send results message to ordering clinician

C. Patient ID cross-referencing

D. Send results message to other authorized providers of care

E. Structure lab result as lab report document

F. Send document to repository, store, and register in data locator service (Note: data repository may be part of EHR or an independent actor)

G. Notification of lab report availability

H. Send report to authorized providers of care

Use Case Scenario #1: Provide new lab results to ordering clinician, to other authorized providers and to data repositories.

A

G

B

D

F

C

E

H


F. Send document to repository, store, and register in data locator service

G. Notification of lab report availability

I. Query data locator service for lab results location and retrieve from repository

J. Query repository and retrieve lab report directly from repository

K. Merge lab results into EHR

L. View lab results from a web application

Use Case Scenario #2: Query repository for retrieval of historical lab results

F

G

J

LK

I


Electronic Health Record (EHR) Laboratory Results Reporting

class EHR Interoperability Specification

«interoperability specification»EHR - Laboratory

+ docId = IS01

«composite stan...IHE PIX

- PIX Query: ITI-9

«base standard»HL7 V2.5 Message

«component»Lab Report Document

Structure

+ docId = C37

«composite standard»IHE XD*-Lab

«composite standard»IHE XDS

+ Register Document Set: ITI-14+ Provide & Register Document Set: ITI-15+ Query Registry: ITI-16+ Retrieve Document: ITI-17

«base standard»ISO 15000 ebRS

«base standard»HL7 CDA R2

«component»Lab Report Message

+ docID = C36

«component»EHR Lab Terminology

+ docId = C35

«composite stand...IHE NAV

«transaction»Patient Demographics

Query

+ docId = T23

«composite stand...IHE PDQ

«base standard»LOINC

«base standard»SNOMED-CT

«base standard»HL7 V2.5 Code Sets

«base standards»HL7 V3.0 Code Sets

«transaction package»Patient ID Cross-

Referencing

+ docId = TP22

«transaction package»Manage Sharing of

Documents

+ docId = TP13

«transaction package»View Lab Results v ia Web Application

+ docId = TP18

«transaction package»Send Lab Results

+ docId = TP14

«component»Secure Web Connection

+ docId = C44

«base standard»IETF HTTPS

«base standard»HL7 Draft "Lab Result to

EHR"

+ pending ballot results

«component»Acknowledgements

+ docId = C45

«transaction»Notification of Document

Availability

+ docId = T29

constrainsconstrainsconstrains

contains

constrains

contains

uses

contains

uses

contains

uses

uses

contains

constrains

uses

contains

references

constrains

implements

contains

references

constrains

constrains

constrains

constrains constrains

constrains

constrains


IS01 Lab Results to EHR – Related Documents Overview

Related Documents Document Description

TP13 HITSP Transaction Package: Manage Sharing of Documents Transaction Package

TP14 HITSP Transaction Package: Send Lab Result Message to Ordering Clinician and Providers of Care Transaction Package

T18 HITSP Transaction: View Lab Result from a Web Application Transaction

TP22 HITSP Transaction Package: Patient ID Cross-Referencing Transaction Package

T23 HITSP Transaction: Patient Demographics Query Transaction

T29 HITSP Transaction: Notification of Document Availability Transaction

C35 HITSP Component: EHR Laboratory Result Terminology Component

C36 HITSP Component: Laboratory Result Message Component

C37 HITSP Component: Laboratory Report Document Component


IS01 Lab Results to EHR

Specifies communication of a lab result to an EHR for the ordering clinician and/or other providers of care

Key Concepts: – Defines both an HL7 2.5.1 message and

HL7 CDA R2 XML document for conveying the content of the report

– Defines alternate actions for retrieval of lab result documents from a repository for web viewing of historical records

– Either a v2 message or an XML document may fulfill the initial lab result and interpretation reporting from the lab; only XML documents are used for historical results.

pkg IS01

«interoperability specification»EHR - Laboratory

+ docId = IS01

«component»Lab Report Document Structure

+ docId = C37


+ docID = C36

«transaction»Patient Demographics Query

+ docId = T23

«transaction package»Patient ID Cross-Referencing

+ docId = TP22

«transaction package»Manage Sharing of Documents

+ docId = TP13


+ docId = TP18


+ docId = TP14

contains

contains

contains

contains

contains

contains

contains


IS01 Lab Results to EHR

Pre- and Post-Conditions– Lab orders are a pre-condition, common meta-data is assumed

Constraints– Use of ISO OIDs for identifiers

– Notification and distribution of results

Security and privacy– Deferred, to be integrated in next version

Gaps– Terminology standards for reporting laboratory results


C36 – Lab Report Message

Defines constraints on an HL7 2.5.1 message specification to address the AHIC use case requirements

Does not include support for anatomic pathology

Refers to C35 for vocabulary and terminology support where HL7 is optional

Constrains data types and cardinality to meet AHIC requirements

pkg C36


+ docID = C36

«base standard»HL7 2.5.1 Message

+ HL7 IG: Lab Result Message to EHR (draft)


+ docId = C35

constrains

references


C37 Laboratory Report Document Structure

Constrains the use of the IHE XD*-Lab Profile which itself is a constrained implementation of the HL7 CDA R2 specification

Refers to C35 for terminology and vocabulary support

Key Concepts– Requires use of “Level 3” data

encoding, e.g., fully computable results

pkg C37

«component»Lab Report Document Structure

+ docId = C37

«composite standard»IHE XD*-Lab

«base standar...HL7 CDA R2

«base standar...HL7 V3 Lab


+ docId = C35

constrainsconstrains

references

constrains


C35 EHR Lab Terminology

Specifies vocabulary for Laboratory Results data

LOINC for top 95% of routine tests reported in HEDIS, plus microbiology and cytology

SNOMED-CT for FDA SPL specified problem list subset

HL7 V2.5 Code Sets and HL7 V3.0 Code Sets

Key Concepts– Augments minimum vocabularies and

terminologies required by base standard

pkg C35


+ docId = C35

«base standard»LOINC

«base standard»SNOMED-CT

«base standard»HL7 V2.5 Code Sets

«base standards»HL7 V3.0 Code Sets

constrains

constrains

constrains

constrains


TP-13 – Manage Sharing of Documents Defines the requirements for the

registration, storage and retrieval of documents across repositories

Specifies a subset of transactions defined in the IHE Cross Document Sharing (XDS) Specification, Dec 2006– ITI 14 Register Document Set

– ITI 15 Provide & Register Document Set

– ITI 18 Registry Stored Query

– ITI 17 Retrieve Document

Key Concepts: Sharing of source attested documents, document content neutral, document registry, document repositories distributed or centralized.

pkg TP13

«composite standard»IHE XDS

+ Register Document Set: ITI-14+ Provide & Register Document Set: ITI-15+ Query Registry: ITI-16+ Retrieve Document: ITI-17

«base standard»ISO 15000 ebRS

«composite standard»IHE NAV

«transaction package»Manage Sharing of Documents

+ docId = TP13

«transaction»Notification of Document Availability

+ docId = T29

uses

uses

constrains

implements


TP-13: Manage Sharing of DocumentsQuerying for, retrieving, and submitting documents

Doc Consumer Doc IndexQuery: Which docs ?

Retrieve doc

Soap EnvelopeSoap Envelope

Soap EnvelopeSoap EnvelopeProvide

Document

Doc Consumer Doc Repository

Doc Source

CDA Rel2

Lab V3

XDS = “FedEx”– A transport envelope, document format- and content- agnostic, with generic

search and retrieve. Supports both push and pull models. Actors are not bound to any RHIO/NHIN architecture.

CDA Rel2

Lab V3


TP13 – Manage Sharing of Documents

Supports concept of affinity domains to scope interoperability

Gaps– An identified gap is the ability to share documents across communities, this

is being discussed in a proposed IHE extension to Cross Document Sharing Profile (XDS) called Cross Community Access Profile (XCA)

– An update to IS-01 is expected to support cross-affinity domain sharing of documents after final XCA is tested and refined


T23 – Patient Demographics Query

Defines the methodology for obtaining a patient identity (or list of patient identities) that match a provided set of patient demographics

IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2):

ITI-21: Patient Demographics Query [§3.21.1]

Key Concepts– Patient Identity Demographics, HL7

Query/Response

– Used to send initial results to non-ordering recipients, and for historical results

pkg T23

«transaction»Patient Demographics Query

+ docId = T23

«composite standard»IHE PDQ


constrains

constrains


TP22 – Patient Identity Cross-Referencing

Defines the methodology for identifying and cross-referencing different patient attributes for the same patient.

IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2):– ITI-8: Patient Identity Feed [§3.8.1]– ITI-9: Pix Query [§3.9.1]

Key Concepts– HL7 Query/Response – Used to send initial results to non-

ordering recipients, and for historical results

pkg TP22

«transaction package»Patient ID Cross-Referencing

+ docId = TP22

«composite standard»IHE PIX

+ Patient Id Feed: ITI-8+ PIX Query: ITI-9


constrains

constrains


TP14 Send Lab Result

Defines the requirements for sending the HL7 2.5.1 Lab Message– Specific transport technology not

constrained to allow NHIN flexibility; at a minimum defaults to HL7 specified methods

Uses C45 Acknowledgements– Specifies system acknowledgement

behavior during message transmission

– Processing example and additional detail on HL7 acknowledgements is expected in the final HL7 v.2.5.1 Lab Interoperability Implementation Guide.

pkg TP14


+ docId = TP14


+ docId = C45

uses


C45 – Acknowledgements

Reports status of messages sent using transactions and transaction packages

HL7 V2.5 Ack

Key Concepts: – Acknowledgements may be either for

successful receipt or unsuccessful receipt

No constraints

Processing example and additional detail on HL7 acknowledgements is expected in the final HL7 v.2.5.1 Lab Interoperability Implementation Guide.

pkg C45



+ docId = C45

constrains


C45 – Acknowledgements

Additional IS01 Constraints– May become obsolete as the HL7 Lab Message IG will specify internally

Gaps– Clarification of system vs. application acknowledgements, types of errors

and system responsibilities


T29 – Notification of Document Availability

Notifies a recipient that a document is available and provides the information needed to retrieve the document

IHE IT Infrastructure (ITI) Technical Framework (TF), Volume 2 (ITI TF-2) Supplement for Notification of Document Availability (NAV)

Key Concepts: – Recommended a ‘publish and subscribe’

mechanism to IHE to make NAV a feasible tool

pkg T29

«transaction»Notification of Document

Availability

+ docId = T29

«composite standard»IHE NAV

uses


TP18 View Lab Results via Web Application

pkg TP18


+ docId = TP18


+ docId = C44

uses

Defines the ability to view a lab result using a web browser

Transform from CDA to any appropriate display format (HTML, XHTML, PDF, etc.)

Calls for a secure web connection for patient privacy


TP18 View Lab Results via Web Application

Additional IS01 Constraints– No predefined style sheets required, follows HL7 CDA R2 for recipients

responsibilities ([§1.3.1]


C44 – Secure Web Connection

Defines the use of IETF HTTPS to establish a secure web connection

Additional security and privacy constructs to be integrated into IS01 in next revision for deferred security requirements, e.g., authentication, role based access

pkg C44


+ docId = C44

«base standard»IETF HTTPS

uses


C44 – Secure Web Connection

Additional IS01 Constraints– Privacy deferred, to be implemented in next version