[Slide 1]{.underline}

**EHR-Laboratory Interoperability and Connectivity Specification;
E-links**

Presentation to A-hick EHR Work Group

February 22^nd^, 2006

Jonah Frohlich, California HealthCare Foundation

Walter Sujansky, Sujansky and Associates, LLC

[Slide 2]{.underline}

**E-links Project Overview**

A national project sponsored by the California HealthCare Foundation;
[www.chcf.org](http://www.chcf.org/)

Motivation

> Streamline the implementation of electronic data interfaces between
> labs and ambulatory EHR's
>
> Expand the electronic delivery of laboratory results to clinicians in
> the office setting
>
> Promote the adoption of EHR's among ambulatory care providers
>
> Initiated in February 2005

[Slide 3]{.underline}

**E-links Project Goals**

An implementation guide for the electronic reporting of lab results

> Detailed specification of the format and coding of lab result
> messages, based on HL7
>
> Detailed interaction rules for laboratory information systems and
> EHR's, based on HL7
>
> Based on requirements of varied stakeholders
>
> EHR vendors, commercial labs, LIS vendors, clinician users, government
> bodies, standards organizations
>
> Balance of ideal requirements and practical capabilities: enable
> near-term adoption
>
> Support for objective conformance testing

[Slide 4]{.underline}

**E-links Use Case: Outpatient Lab Testing**

At the left is a vertical line labeled MD. A rightward arrow labeled
Order Entry points from the top of the MD line to a vertical line
labeled EHR. A rightward arrow labeled Order Generated by EHR, Order
Received at Laboratory points from the top of the EHR line to a vertical
line labeled Laboratory. The word Laboratory has an asterisk which leads
to the words Hospital, Commercial, or Clinic. The middle of the
Laboratory line has these worded concepts illustrated in descending
order: Data Entered or Imported, Specimen Collected or Delivered, and
Test Performed. A leftward arrow labeled Result Transmitted
Electronically to EHR points from the bottom of the laboratory line to
the EHR line. The title of that arrow is enclosed in a drawn oval, and
an arrow points from that oval to the words Covered by E-links
Specification. A leftward arrow labeled Result Review slash Decision
Support points from the bottom of the EHR line to the MD line.

[Slide 5]{.underline}

**Scope of E-links Version One Point O**

Includes

> Standardized format and content of lab result messages
>
> Standardized interaction model for exchanging lab result messages
>
> Standardized coding of common tests: LOINC

Excludes

> Standardized format for lab orders
>
> Transport technologies, encryption slash authentication mechanisms,
> and message-routing services

[Slide 6]{.underline}

**E-links Development Process**

Multidisciplinary technical working group

> Membership by nomination and invitation

Consensus-based decision making

> Discussion and consensus in work group
>
> Public comment period to collect wider industry input
>
> Thorough documentation of process

Guidance from external steering committee

[Slide 7]{.underline}

**Technical Working Group Representation**

Commercial Laboratories

> Ameripath
>
> Lab Corp
>
> Quest Diagnostics

EHR Vendors

> All-Scripts
>
> Emdeon; Web-MD
>
> e-MD's
>
> Next Gen

Hospital LIS Vendors

> GE Medical Technologies
>
> Misys

Government

> CDC
>
> CMS
>
> VA

Other Organizations

> American College of Physicians
>
> eHealth Initiative
>
> Indiana Health Information Exchange

[Slide 8]{.underline}

**Steering Committee**

Jason DuBois\
Vice President, Government Relations\
American Clinical Laboratory Association; ACLA

Donald T Mon, PHD\
Vice President, Practice Leadership\
American Health Information Management Association; AHIMA

Charles Parisot\
Chair, Standards and Interoperability Workgroup[\
]{.underline}EHR Vendor Association, HIMSS

Rod Piechowski\
Vice President, Technology Leadership\
National Alliance for Health Information Technology; NAHIT

Wesley Rishel\
Director at Large and Past Chair\
Health Level 7; HL7

John Tooker, MD, MBA, FACP\
Executive Vice President and Chief Executive Officer\
American College of Physicians; ACP

Patricia Wise, RN, MA, MSN\
Director\
EHR Initiative, HIMSS

[Slide 9]{.underline}

**E-links Status**

Version One Point O completed and published July 2005

> Available at [www.elincs.org](http://www.elincs.org/)

Version One Point O pilots projects initiated February 2006

> Goal: Reference implementations of E-links Version One Point O
>
> Five grantees in California
>
> Include physician groups, EHR vendors, and laboratories

[Slide 10]{.underline}

**E-links Pilot Project Grantees**

1: Brown and Toland Medical Group

> At the left is an icon labeled All-Scripts Touch-works. Two-way arrows
> connect it to icons at the right labeled Lab Corp and UCSF Hospital.

2: Cedars-Sinai Medical Foundation

> At the left is an icon labeled GE Centricity. A two-way arrow connects
> it to an icon at the right labeled Quest Diagnostics.

3: Southern Sierra Medical Clinic

> At the left is an icon labeled e-MD's Chart. A two-way arrow connects
> it to an icon at the right labeled Ridgecrest Hospital: McKesson.

[Slide 11]{.underline}

**E-links Pilot Project Grantees**

4: Humboldt Del Note IPA

> At the left is an icon labeled Aristos Peck-sis. Two-way arrows
> connect it to icons at the right labeled Lab Corp, Saint Joseph's
> Hospital, and Clinic Laboratory: Lab-Daq.

5: Redwood Community Health Coalition

> At the left is an icon labeled I-two-I Systems Meditracks. A two-way
> arrow connects it to an icon at the right labeled Quest Diagnostics.

[Slide 12]{.underline}

**E-links Pilot Project Timeline**

The timeline goes from March to September 2006 and then skips ahead to
February 2007. March O6 is labeled Project Kickoff. May 2006 is labeled
E-links Testing Tool Released: Beta. The period of June to August 2006
is labeled Preliminary Results Available. August 2006 is labeled E-links
Version 1.1, as Required. February 2007 is labeled Final Project Results
and Evaluation.

[Slide 13]{.underline}

**E-links and CCHIT**

CCHIT has proposed E-links Version One Point O compatibility as a
certification criterion for ambulatory EHR products in 2006 slash 2007

E-links is working with CCHIT to support certification process

[Slide 14]{.underline}

**What Is E-links Conformance?**

EHR includes all required data elements on the lab orders it generates

EHR can receive HL7 Version 2.4 result messages

EHR can recognize, parse and process the three E-links message types

EHR fulfills all receiver responsibilities

> Sends acknowledgement messages
>
> Appropriately stores and displays information designated by CLIA

[Slide 15]{.underline}

**E-links Roadmap**

E-links Version Two Point O; March 2006

> Standardized structure for microbiology results
>
> LOINC coding for 95 percent most common tests

E-links Orders; 2007?

> Standardized interaction and message format for electronic orders

E-links Version Three Point O; 2008?

> Snow-med coding, units coding
>
> Structured pathology reporting

[Slide 16]{.underline}

**E-links Versions One Point O and Two Point O**

Version Two Point O is an extension of Version One Point O

> Addition, not replacement, of features
>
> Backward compatibility

Version Two Point O is more complex and will take labs longer to
implement

Version One Point O has been proposed as an EHR certification criterion
for 2006

Therefore: Organizations can implement Version One Point O now and
Version Two Point O later

[Slide 17]{.underline}

**E-links Long-term Maintenance**

Following pilot implementations of Version One Point O, E-links will be
transitioned to an appropriate organization

> Ongoing implementation support for Version One Point O
>
> Reference implementations of Version Two Point O
>
> Ongoing maintenance and enhancements

Health Information Technology Standards Panel

> Do HITSP tasks include maintenance of implementation guides for health
> data interoperability?

E-links also in discussion with HITSP member organizations, including
IHE

[Slide 18]{.underline}

**Questions\
Comments\
Feedback**

[Slide 19]{.underline}

**E-links Format and Content: Message Structure**

ORU message type; HL7 Version 2.4

The leftmost column in the table is labeled Segment ID and contains
computer code. The next column is labeled Usage. In it, according to the
legend, the letter R means Required Always, RE means Required if Data
Available, and X means Not Supported. Lines with an X are shown grey in
every column. The third column is labeled Cardinality. It shows brackets
containing two dots between ones, zeros, and-or stars. One line shows
nothing but two stars in the Usage column and the same in the
Cardinality column. The rightmost column is labeled Segment Name.

[Slide 20]{.underline}

**E-links Version One Point O: Lab Testing Data Model**

On this slide, small red text at the right identifies numbers needed for
each part of the model. Each type of number starts with OB.

Lab Requisition; Patient, Provider: OBR2 Placer Order Number

> 1: Ordered Test; CBC: OBR4 Universal Service ID
>
> A: Reported Analyte; WBC equals 12,000: OBX3 Observation ID
>
> B: Reported Analyte; HCT equals 41 percent: OBX3 Observation ID
>
> C: Reported Analyte; PLT equals 300,000: OBX3 Observation ID
>
> 2: Ordered Test; Pap Smear: OBR4 Universal Service ID
>
> A: Reported Analyte; Path Report equals Mild Atypia: OBX3 Observation
> ID

[Slide 21]{.underline}

**E-links Format and Content: Message Structure**

Example: OBX

The leftmost column in the table is labeled SEQ and contains the numbers
1 through 19 in order. The next column is labeled Element Name. The
third column is labeled LEN and contains various values ranging from 1
to 65,536; the number 250 comes up often. The fourth column is labeled
Data Type and contains sets of letters, mostly pairs, not identified in
the legend. They include SI, ID, CE, ST, IS, NM, ID, TS, XCN, and EI.
There is also one line with a star instead of letters in that column.
The fifth column is labeled Usage. In it, according to the legend, R
means Required Always, RE means Required if Data Available, O means
Optional, C means Conditional, and X means Not Supported. The rightmost
column is labeled Cardinality. It shows brackets containing two dots
between ones, zeros, and-or stars, except one line in which the second
number is 5.

[Slide 22]{.underline}

**E-links Format and Content: Field Definitions**

Example: OBX3 Observation Identifier

In this screen capture, the paragraph lead-in E-links Specifications
introduces a few paragraphs on LOINC codes. In the center is a table
entitled Field: OBX3 Observation Identifier. Its left column is labeled
Component Slash Subcomponent and shows either ST or IS in parentheses
after each term. Its right column is labeled Usage and contains either R
or RE for each line. Beneath the table is a section entitled E-links
Sample Values. It contains code with bracketed explanations.

[Slide 23]{.underline}

**E-links Interaction Model: Based on HL7 Version Three Point O**

This slide shows two vertical lines labeled Order Fulfiller, LIS, and
Result Receiver, EHR. The words Order Fulfiller and Result Receiver are
encased in a box tagged 1: Application Roles. A rightward arrow points
from the LIS line to the EHR line. To the left of the arrow are the
words Result Available, which appear in a box tagged 2: Trigger Event.
Above the arrow are the words Result Available, IN3, which appear in a
box tagged Interaction. Below the arrow, in brackets, is written MT Dash
ORU Dash 2, which appears in a box tagged 3: Message Type. Below that
label and to the right of the EHR line is written 4: Receiver
Responsibilities.

[Slide 24]{.underline}

**E-links Interaction Model: Supported Interactions**

This slide shows three vertical lines. From left to right, they are
labeled Order Placer, EHR System; Order Fulfiller, LIS; and Result
Receiver, EHR System. The first and third labels are enclosed in drawn
ovals. A dotted rightward arrow points from the Order Placer line to the
Order Fulfiller line. To the left of that arrow are the words Order
Entry, which appear in a box tagged Lab Order Entered into EHR. Above
the dotted arrow are the words Order Fulfillment Request, IN1. Below the
dotted arrow are the bracketed and quoted words Virtual Order Message,
which appear in a box. That box is tagged with a two-bullet list: Not an
HL7 Message, and Set of Data Elements That Are Required on Every Order.
Three full rightward arrows point from the Order Fulfiller line to the
Result Receiver line. In descending order, the arrows are labeled Result
Status, IN2, MT Dash ORU Dash 1; Result Available, IN3, MT Dash ORU Dash
2; and Result Correction, IN4, MT Dash ORU Dash 3. Each arrow is tagged
with a numbered list. For the Result Status arrow, it is 1, Specimen
Received; 2, Entire Test Cancelled. For the Result Available arrow, it
is 1, Preliminary Result; 2, Final Result. For the Result Correction
arrow, it is 1, Incorrect Result Value Was Sent; 2, Result Was Sent for
Incorrect Patient. Below these arrows, a full leftward arrow points from
the Result Receiver line to the Order Fulfiller line. It is labeled
Result Confirm Response, IN5, MT Dash ACK Dash 1. This arrow is tagged
Result Message Received.

[Slide 25]{.underline}

**E-links Interaction Model: Documentation**

The top of the table reads Interaction: Result Status, IN2. From left to
right, the columns are labeled Component, Description, and Comment.
Components include Trigger Event, Application Roles, Message Type, and
Receiver Responsibilities.

[Slide 26]{.underline}

**EHR Receiver Responsibilities**

Acknowledging receipt of lab messages

> Releases lab from need to resend message

Storing and displaying certain information

> Test cancellations
>
> Identity of the lab performing the test
>
> Required to assure labs of CLIA conformance: Clinical Laboratory
> Improvement Amendments

Example: Producer ID

[Slide 27]{.underline}

**E-links Interaction Model: Virtual Orders**

This slide shows three vertical lines. From left to right, they are
labeled Order Placer, EHR System; Order Fulfiller, LIS; and Result
Receiver, EHR System. The first and third labels are enclosed in drawn
ovals. A dotted rightward arrow points from the Order Placer line to the
Order Fulfiller line. To the left of that arrow are the words Order
Entry. Above the dotted arrow are the words Order Fulfillment Request,
IN1. Below the dotted arrow are the bracketed and quoted words Virtual
Order Message, which appear in a box. That box is tagged with a
two-bullet list: Not an HL7 Message, and Set of Data Elements That Are
Required on Every Order. Three full rightward arrows point from the
Order Fulfiller line to the Result Receiver line. In descending order,
the arrows are labeled Result Status, IN2, MT Dash ORU Dash 1; Result
Available, IN3, MT Dash ORU Dash 2; and Result Correction, IN4, MT Dash
ORU Dash 3. Below these arrows, a full leftward arrow points from the
Result Receiver line to the Order Fulfiller line. It is labeled Result
Confirm Response, IN5, MT Dash ACK Dash 1.

[Slide 28]{.underline}

**Virtual Order Message**

EHR Responsibilities

> Include required data elements on all orders
>
> Examples: Requisition ID, Ordering Provider, Patient Name, Ordered
> Test ID's, et cetera

Lab Responsibilities

> Record required data elements on the order
>
> Store data elements during lifetime of the order
>
> Include data elements in all E-links status slash result messages

Example: Ordered Test ID

[Slide 29]{.underline}

**Standard Coding for Common Tests**

LOINC codes required for top 80 percent of tests, by frequency

> About 100 tests, based on data from 3 large CA provider groups

Tests enumerated in E-links specification

Examples:

> In a table, from left to right, the columns are labeled Test Category,
> Test, Test Description, LOINC Codes, and Sample Values.