S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
Meeting Summary
Date: 02/17/11
Name: Laboratory Results Interface Initiative (LRI) Use Case and Requirements (UCR) Workgroup
Session 3
Agenda/Objectives:
 Administration
 Active Discussion
o Overview and Scope
o Challenge Statement
o Value Statement
 Homework
Attendees:
Panelist Attendees:
 Arien Malec
 Jitin Asnaani
 Ed Larsen
 Merideth Vida
 Heather Stevens
Webinar Attendees:
Amram Ewoo, Amy Goring, Andriy Selivonenko, Arturo Sanchez, Austin Kreisler, Bob Lutolf, Brandy
Hays, Brian Pech, Cindy Vinion, David Cheng, Ed Larsen, Elliot Sloane, Freida Hall, Gaby Jewell, Gai
Elhanan, Glen Moy, Greg Chittim, Hans Buitendijk, Hari Ramachandran, John Ritter, John Stinn,
Jonathan Tadese, Justin Austin, Kathy Walsh, Ken Gerlach, Ken Willett, Ken McCaslin, Kosta
Makrodimitris, Lorre Pacheco, Michael Trebatoski, Michael Nenashev, Neeli Bajaj, Pat Wolfram,
Randolph Sanks, Riki Merrick, Robert Coli, MD, Robert Hausam, Robert Dieterle, Robert, Robert
Snelick, Roger Hornsby, Rosa Aleman, Smriti Singal, Steve Hufnagel, Thanos Tsiolis, Tynisha Carter,
Victoria Njoku, Virginia Riehl, Wayne King
Action Item
Post meeting summary from
WG meeting to wiki
Next Steps / Status
In Progress
Continue to review and
comment on: Overview and
Scope, Challenge Statement,
and Value Statement for the
next WG meeting.
Add in suggested language and
additional comments into the
review log on how to define
“structured data” within the
Overview and Scope section.
In Progress
In Progress
Lead
WG
Support
Leads
N/A
Committed
Members
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
Contributors Due Date
N/A
2/20/2011
WG
Participants,
Committed
Members
3/2/2011
3/3/11
1
S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
Meeting Summary
In Progress
Document resolutions captured
during workgroup call and post
to the appropriate review log.
Revisit open comments
Coordinate additional training on
Wiki Navigation
Sign Up for Sub Workgroups on
the Wiki
Arrange and post details for an
“Office Hours” session, with the
LRI Support Team, at the S&I
Framework Booth During
HIMSS
In Progress
In Progress
WG
Support
Leads
All
3/1/2011
WG
Support
Leads
WG
Support
Leads, S&I
Functions
Committed
Members
WG
Support
Leads
All
3/3/2011
To be
scheduled
for after
HIMSS
3/3/11
2/21/11
Notes from Discussion:
Administrative:
- Next meeting will be held two weeks from now due to the HIMSS conference, LRI workgroup
meetings will resume on 3/3/2011
- The time for the LRI workgroup meetings has been changed to 2:30pm-4:00pm EST. This
change will take effect 3/3/2011.
- Transition of Care (TOC) workgroup is in the process of setting up a sub-workgroup to work on
Use Case simplification. This group will focus on the outline for the Use Case models and how to
structure it in a way to leverage existing work and to allow for reuse in the future. This subworkgroup will cut across all of the UCR workgroups for TOC and LRI, all individuals are invited
to participate in the workgroup. Gary Dickinson is one of the co leads. A second co-lead will be
selected by participating members. More information will be posted on the wiki on how to sign
up for this sub workgroup. This sub workgroup is scheduled to start the week after HIMSS on
3/3/2011
- Based on the outcomes of last week’s discussion a sub workgroup has been created as part of
the LRI UCR workgroup to address defining the appropriate list of In Scope lab tests. Ken
McCaslin has agreed to be the co lead. A second co-lead will be selected by participating
members. More information will be posted on the Wiki for individuals to sign up. This sub
workgroup is scheduled to start the week after HIMMS on 3/3/2011
- A training session will be scheduled post HIMSS to train those workgroup members that need
assistance navigating the wiki site.
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
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Meeting Summary
S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
Notes from Active Discussion:
General Topics:
-
Q: Will there be an opportunity during the HIMSS conference to get together with representatives
from the LRI Initiative to go over co lead responsibilities, to ensure that the desired outcomes are
met within the sub workgroup meetings?
A: Ed, Heather, and Merideth will all be at the HIMSS conference and will arrange a time when
they will be available during the conference to meet the workgroup members and to answer any
questions.
Q: Several people are going to HIMSS.I was wondering if there is going to be a common place
for everyone to meet?
A: The S&I framework will have a kiosk in the interoperability showcase; representatives will be
there from the S&I Framework Support teams. “Office hours” will be set for workgroup members
to stop by the booth. This information will be posted to the wiki site so that those of you in
attendance can make plans to stop by the booth if you are interested.
Q: Would you please add an announcement on the Wiki stating where the kiosk is going to be
located at HIMSS
A: Relevant HIMSS information will be posted to the wiki site.
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-
Overview and Scope:
Comment # 1 & 2: Glen Moy
1.
2.
Just reiterating my comment regarding greater specificity in defining "transactions" (fourth item under successful outcomes
for the initiative); perhaps "Number of lab results reporting-related transactions?"
Insert "of ambulatory" into the first bullet for consistency; so revised sentence would read "Sending and Receiving of
ambulatory primary care clinical laboratory test results."
Response/ Discussion:
- The comment was included for clarification purposes.
Resolution:
- These edits will be made and the review log will be updated to document the action taken.
Comment # 3: Arturo Sanchez-Ruiz
Please clarify the following with respect to the two bullets:
- "Sending and Receiving primary care core clinical laboratory test results": who sends and who receives?
- "Incorporate clinical laboratory test results into certified EHR as structured data": clarify the meaning of "incorporate"; and "structured
data"
Response/ Discussion:
- The comment was included for clarification purposes, the current language does not specify who
will be sending and receiving the test results.
- The scope of this Use Case focuses on sending lab results from an LIS to EHR system.
- Q: What is meant by structured data?
- A: This language was pulled from the MU final rule.
- The meaningful use criterion does specify that laboratory results need to be incorporated into the
EHR as structured data.
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
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Meeting Summary
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S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
Q: Can’t CLIA be referenced to help define structured data?
A: CLIA defines specific requirements for the display of information. The CLIA requirements
should be utilized as a basis when defining structured data.
CLIA is a good reference for lab categories and types of data.
The problem with pointing to CLIA is that their definition doesn’t get to the appropriate level of
specificity. CLIA considers a PDF with all of the lab results in the PDF as text as structured data.
The text includes a specific list of information but the focus of this initiative should expand this
definition of structured data.
The intent of this Use Case is to provide information to an EHR that is sufficient for the EHR to
clearly meet the requirements to incorporate lab results as structured data.
The lab should be responsible for defining the requirements on how the data should be
structured. There are rules, requirements and guidelines for CLIA, JCAHO, CAP and these
should be taken into consideration when defining structured data.
Developing the Use Case and getting into the specific details will result in what structured data
should be within the context of this Use Case.
This group is not going to be able to define how data is rendered within an EHR; EHR vendors
are ultimately in control of that. A boundary will need to be drawn between and/or in front of the
EHR. This group can define what the HL7 data looks like before it arrives at the EHR and then
assume that the EHR renders it correctly.
The EHR certification criterion does not assume that the data has been rendered appropriately.
There is a requirement to validate the data that is received is correct and the LRI UCR
workgroup should focus on meeting that criteria otherwise there will be issues for labs.
This workgroup needs to define how the data is delivered using an HL7 message.
Q: Since the data is traveling from the LIS to the EHR and therefore needs to be incorporated
within the EHR, can’t the scope be further defined to by requiring the data to be generic and in
alignment with the metadata model of the EHR?
A: You don’t want to refer to specific metadata models but you know that it has to comply or
align with the receiving system. EHR’s represents data to meet their specific needs and desires
to support specific functional capabilities. Would not want to state that the data has to adhere to
a specific EHR data model and/or metadata model. The communication model needs to be
defined and the EHR systems should adhere to that.
The PCAST report did include some suggestions. They don’t address the whole area but they
some kind of interpretation for structured data. Some scientists think that structured data is a
whole amount of data that you need to exchange.
Resolution:
- Update section 2.1 In Scope to include a new bullet to capture the sending and receiving
systems.
o New Bullet: Laboratory Information Systems will be the sender of laboratory test results
while EHR systems will be the receiver.
- A structured data sub workgroup will be created to address this issue. Kosta Makrodimitris has
volunteered to co lead the sub workgroup. Information on how to participate as part of this sub
workgroup will be posted to the wiki site
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
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Meeting Summary
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S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
Committed members are asked to provide suggested definitions for structured data in the context
of lab results posts it to the Wiki in the review log.
Comment # 4 &5: Jim Harrison
4.
5.
I have some concern that standards for results transmission that are defined outside of a more complete order-result
communication context may be incomplete or may require assumptions that are ultimately limiting. For example, is it
reasonable to constrain HL7 results reporting messages adequately to allow "plug and play" with consequent significant
reduction in implementation time and cost, without considering order messages? Results messages carry OBR segments
with order information, and constraining these segments would appear to require constraint of the order messages from
which they are derived.
Do "clinical laboratory test results" in this context include decision support content, including links to external content, that
may be incorporated by the system the originates the results?
Response/ Discussion:
Jim was not on the line
Resolution:
We will postpone these comments until our next meeting.
Comment # 6: Austin Kreisler
Just what sort of Lab results are considered "specialty" lab results? Are micro-results considered "specialty"? What about newborn
screening? Genetic testing? Anatomic Pathology? I suggest micro needs to be in scope.
Response/ Discussion:
The In Scope Tests sub workgroup was created as a result of last week’s meeting to address this
question.
Resolution:
Austin will sign up to participate in sub workgroup to help resolve this issue.
Comment # 7: Austin Kreisler
Need clarification on the following:
"Hospital ordering and reporting of laboratory results"
Why are Hospital Lab results out of scope? The bulk of results today are generated by Hospital labs. Hospital labs serve both the
acute care and ambulatory care spaces. It seems to me leaving out such a significant sector of the lab market is a serious omission.
Response/ Discussion:
- Hospital labs play in the ambulatory space and for that reason reporting of laboratory results
should be considered within the scope of this Use Case.
- If the scope is revised to be inclusive of results provided by hospitals based labs in the
ambulatory setting this would clarify what is in and out of scope.
- In past efforts conducted by the broader community, intra-organizational interoperability was not
included. This goes back to HITSP and is still the focus of the certification of meaningful use. We
are creating standards between organizations and what goes on within an organization has
always been out of scope.
- This workgroup should focus on standardizing the content of the result reporting message. How
and where this message is message is going to be sent or received is irrelevant. As long as the
data comes from something else that is not the patient EMR it doesn’t matter if the exchange is
within the organization or outside of an organization and/or a national reference lab organization
- This Use Case should focus on developing requirements for supporting the primary care setting
and if the requirements can be used in other settings that would be an added benefit. The issue
is defining what the basic requirements are, how harmonization and implementation guides are
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
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Meeting Summary
S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
addressed needs to be done by November. We want to be informed by in patient results but that
is not within the requirements of this specific use case right now.
Resolution:
Including acute hospital inpatient laboratory tests will be discussed as part of the In Scope Tests sub
workgroup but the focus is lab test results used for primary care in the ambulatory setting, informed by
needs of in-patient test results.
Comment # 10: Riki Merrick
Even though neither of the constrainable profiles - HITSP or ELINCS have been widely adopted, it should be considered, that the
HITSP profile was incorporated using a harmonization strategy by the ELR constrainable profile, which is already identified as the
standard for reporting lab results to Public Health in meaningful use stage.
Response/ Discussion:
- Goes back to the issue, “If you’ve seen one lab interface you have seen one lab interface“.
- There is actually a family of implementation guides built on top of the HITSP-IS/01 EHR Lab
Result Reporting Interoperability Specification and there is another one for kinetic testing. The
ELR to public health IG actually lays out the strategy for creating a harmonized set of
implementation guides and profiles that work together.
Resolution:
This will be left open for further consideration as the workgroup moves forward in defining the Use
Case and a consideration for the Harmonization WG.
Comment # 15: Jim Carlson
Clarify bullet #2: "Incorporate clinical laboratory test results into certified EHR as structured data". It is not the responsibility of the
interface to incorporate the data into the EHR. I suggest this be changed to "Transmit clinical laboratory test results as structured
data"
Response/ Discussion:
- Incorporate comes from the meaningful use final rule
- Meaningful use is based on the EHR system and this team is focusing on the interface between
the lab and EHR. Since the interface is the focus of this Use Case the statement should be
revised so it focuses on the transmission of data and not the reception of that data.
- The interface will enable incorporation.
- There is already a requirement on the EHR vendor for certification to be able to read structured
lab data and present it.
- The goal is that people use the outcomes of this initiative which will be the specifications and
implementation guides.
- Propose to revise the language to state that the interface enables the incorporation of the
structured data into the EHR system.
- It is not the responsibility of the interface to incorporate the data into the EHR. Scope statement
should be changed to "Transmit clinical laboratory test results as structured data."
- A reference to Meaningful Use should also be included in the revised statement.
Resolution:
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
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Meeting Summary
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S&I Framework
Use Case and Requirements Workgroup
Laboratory Results Interface
Update the text to read as follows: “To support certification criteria and Meaningful Use
requirements the Use Case will develop requirements to enable the incorporation of clinical
laboratory test results into certified EHR as structured data.”
Comment # 17: David Cheng
I share the same concern stated in comment #3 (Jim Harrison). In our experience implementing numerous lab results delivery to the
various EHR, the results will need to be tied to an order or they'll just be either rejected or dropped into a notes "bucket" (miles varied
by EHR). In addition, there are two other issues that we run across quite often that I believe we need to consider with our use cases.
First, the need to match the patient. How do we ensure that there is sufficient data elements in the results to confidently identify the
patient and match that patient to the record in the EHR? Second, how do we *maintain* compendiums/order sets on both side of the
interface. They're regularly updated on one side and not the other which can cause mapping/interpretation issues.
Response/ Discussion:
- When clinical or laboratory results are delivered the results need to get to the right patient. One
of the things that a lot of time is spent on is trying to accurately tie the right results to the right
patient. Different EMR’s have their own process.
- Once an implementation is complete getting the results transmitted into the EMR and EHR can
be challenging. If it’s a set of results gets changed or modified the results get kicked out.
- This should be taken into consideration when creating the Use Cases.
- All of these issues will drive up cost
- Q: Are we limiting ourselves to just lab results coming back from laboratories as opposed to the
exchange of lab results between primary care and specialty physicians?
- A: This is a key consideration for harmonization workgroup.
Resolution:
The need to correctly associate lab results with the correct patient is a clear requirement of the Use
Case. This issue is still open for further consideration and refinement during the development of the
Use Case.
Laboratory Results Interface Initiative – UCR Workgroup Session 3, 02/17/11
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