Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Laboratory Orders
Interface Initiative
Electronic Ordering of Laboratory Tests
(in the Ambulatory Setting)
7/26/2012
7/26/2012
1
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Table of Contents
1.0 Preface and Introduction ........................................................................................................................ 6
2.0 Initiative Overview .................................................................................................................................. 6
2.1 Initiative Challenge Statement............................................................................................................ 6
3.0 Use Case Scope ....................................................................................................................................... 7
3.1 Background ......................................................................................................................................... 7
3.2 In Scope ............................................................................................................................................... 7
3.3 Out of Scope........................................................................................................................................ 7
3.4 Communities of Interest ..................................................................................................................... 8
4.0 Value Statement ..................................................................................................................................... 9
5.0 Use Case Assumptions ............................................................................................................................ 9
6.0 Pre-Conditions....................................................................................................................................... 10
7.0 Post Conditions ..................................................................................................................................... 11
8.0 Actors and Roles ................................................................................................................................... 11
9.0 Use Case Diagrams ................................................................................................................................ 12
10.0 Scenario 1 – Electronically Ordering a New or Scheduled Laboratory Test(s) ................................... 13
10.1 User Story........................................................................................................................................ 13
10.2 Activity Diagram – Base Flow .......................................................................................................... 14
10.2.1 Base Flow Table........................................................................................................................ 14
10.3 Activity Diagram - Alternative Flow (Receiving Status Updates) .................................................... 15
10.3.1 Alternative Flow Table – Receiving Status Updates................................................................. 16
10.4 Functional Requirements ................................................................................................................ 16
10.4.1 Information Interchange Requirements .................................................................................. 16
10.4.2 System Requirements .............................................................................................................. 17
10.5 Sequence Diagram .......................................................................................................................... 18
11.0 Scenario 2 - Electronically Ordering an Add- On Laboratory Test(s) .................................................. 18
11.1 User Story........................................................................................................................................ 18
11.2 Activity Diagram .............................................................................................................................. 19
11.2.1 Base Flow ................................................................................................................................. 20
11.3 Functional Requirements ................................................................................................................ 20
11.3.1 Information Interchange Requirements .................................................................................. 20
7/26/2012
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
11.3.2 System Requirements .............................................................................................................. 21
11.4 Sequence Diagram .......................................................................................................................... 21
12.0 Scenario 3 – Requesting Status on a Previously Placed Laboratory Order ......................................... 22
12.1 User Story........................................................................................................................................ 22
12.2 Activity Diagram .............................................................................................................................. 23
12.2.1 Base Flow ................................................................................................................................. 23
12.3 Functional Requirements ................................................................................................................ 24
12.3.1 Information Interchange Requirements .................................................................................. 24
12.3.2 System Requirements .............................................................................................................. 25
12.4 Sequence Diagram .......................................................................................................................... 25
13.0 Scenario 4 – Requesting the Cancellation of a Previously Placed Laboratory Order ......................... 25
13.1 User Story........................................................................................................................................ 26
13.2 Activity Diagram .............................................................................................................................. 27
13.2.1 Base Flow ................................................................................................................................. 27
13.3 Functional Requirements ................................................................................................................ 29
13.3.1 Information Interchange Requirements .................................................................................. 29
13.3.2 System Requirements .............................................................................................................. 29
13.4 Sequence Diagram .......................................................................................................................... 30
14.0 Scenario 5 –A Laboratory Cancels a Previously Placed Laboratory Order .......................................... 30
14.1 User Story........................................................................................................................................ 30
14.2 Activity Diagram .............................................................................................................................. 32
14.2.1 Base Flow ................................................................................................................................. 32
14.3 Functional Requirements ................................................................................................................ 33
14.3.1 Information Interchange Requirements .................................................................................. 33
14.3.2 System Requirements .............................................................................................................. 34
14.4 Sequence Diagram .......................................................................................................................... 34
15.0 Risks, Issues and Obstacles ................................................................................................................. 34
16.0 Dataset Requirements ........................................................................................................................ 36
Appendices.................................................................................................................................................. 43
Appendix A: LOI Glossary ....................................................................................................................... 43
Appendix B: Additional Laboratory Cancellation Reasons ..................................................................... 44
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Appendix C: Related Use Cases .............................................................................................................. 45
Appendix D: Previous Work Efforts........................................................................................................ 46
Appendix E: References .......................................................................................................................... 46
List of Figures:
Figure 1: Use Case Diagram ........................................................................................................................ 12
Figure 2: Context Diagram .......................................................................................................................... 13
Figure 3: Scenario 1 Activity Diagram - Base Flow ...................................................................................... 14
Figure 4: Scenario 1 Activity Diagram - Alternative Flow ........................................................................... 16
Figure 5: Scenario 1 Sequence Diagram ..................................................................................................... 18
Figure 6: Scenario 2 Activity Diagram ......................................................................................................... 19
Figure 7: Scenario 2 Sequence Diagram ..................................................................................................... 21
Figure 8: Scenario 3 Activity Diagram ......................................................................................................... 23
Figure 9: Scenario 3 Sequence Diagram ..................................................................................................... 25
Figure 10: Scenario 4 Activity Diagram ....................................................................................................... 27
Figure 11: Scenario 4 Sequence Diagram ................................................................................................... 30
Figure 12: Scenario 5 Activity Diagram ....................................................................................................... 32
Figure 13: Scenario 5 Sequence Diagram ................................................................................................... 34
List of Tables:
Table 1: Communities of Interest ................................................................................................................. 9
Table 2: Actors and Roles ............................................................................................................................ 12
Table 3: Scenario 1 Base Flow ..................................................................................................................... 15
Table 4: Scenario 1 Information Interchange Requirements...................................................................... 17
Table 5: Scenario 1 System Requirements.................................................................................................. 17
Table 6: Scenario 2 Base Flow .................................................................................................................... 20
Table 7: Scenario 2 Information Interchange Requirements ..................................................................... 20
Table 8: Scenario 2 System Requirements ................................................................................................. 21
Table 9: Scenario 3 Base Flow ..................................................................................................................... 24
Table 10: Scenario 3 Information Interchange Requirements.................................................................... 25
Table 11: Scenario 3 System Requirements................................................................................................ 25
Table 12: Scenario 4 Base Flow .................................................................................................................. 29
Table 13: Scenario 4 Information Interchange Requirements ................................................................... 29
Table 14: Scenario 4 System Requirements................................................................................................ 29
Table 15: Scenario 5 Base Flow ................................................................................................................... 33
Table 16: Scenario 5 Information Interchange Requirements ................................................................... 34
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Table 17: Scenario 5 System Requirements................................................................................................ 34
Table 18: Dataset Requirements................................................................................................................. 42
7/26/2012
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
1.0 Preface and Introduction
To fully realize the benefits of health IT, the Office of the National Coordinator for Health Information
Technology (ONC), as part of the Standards and Interoperability (S&I) Framework is developing Use
Cases that define the interoperability requirements for high priority health care data exchange,
maximize efficiency, encourage rapid learning, and protect patients’ privacy in an interoperable
environment. These Use Cases address the requirements of a broad range of Communities of Interests
including; patients, their significant others and family members, providers, payers, vendors, standards
organizations, public health organizations, and Federal agencies.
These Use Cases describe:




The operational context for the data exchange
The stakeholders with an interest in the Use Case
The information flows that must be supported by the data exchange
The types of data and their specifications required in the data exchange
The Use Case is the foundation for identifying and specifying the standards required to support the data
exchange and developing reference implementations and tools to ensure consistent and reliable
adoption of the data exchange standards.
2.0 Initiative Overview
The Laboratory Orders Interface (LOI) Initiative is focused on the creation of an Implementation Guide
(IG) for the ambulatory setting that builds on the architecture and design of the California HealthCare
Foundation’s (CHCF) EHR-Lab Interoperability and Connectivity Specification (ELINCS) Laboratory Orders
and the Health Level Seven (HL7) Version 2.5.1 Implementation Guide: S&I Framework Lab Results
Interface, Release 1 - US Realm (July 2012)(LRI IG).
Further, the Initiative seeks to design an IG that can serve as a foundation for eventual use in acute care
and public health and incorporate vocabulary consistent with the above mentioned guides as well as
support for the HL7 Electronic Directory of Service (eDOS) IG. Additionally, tools will be developed to
aid evaluation and adoption of messages compliant with the LOI IG generated by Electronic Health
Records (EHR) Systems and Laboratory Information Systems (LIS).
2.1 Initiative Challenge Statement
The lack of a single, comprehensive implementation guide for laboratory orders interfaces is a major gap
in the healthcare standards portfolio. The lack of clear and interoperable implementation guidance for
laboratory orders that is aligned with other laboratory data exchange implementation guidance drives
up the cost, effort, and time to implement an interface and consequently hampers broad adoption of
such interfaces.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
3.0 Use Case Scope
The scope of this Use Case encompasses the electronic communication of laboratory order information
between an Electronic Health Record System (EHR) and a Laboratory Information System (LIS) in an
ambulatory care setting. This includes new, scheduled, add-on laboratory orders; cancellation of
laboratory orders that were previously placed; and status requests. However, the resulting IG may also
be useful for ordering of laboratory tests in non-ambulatory care settings. Anatomic pathology and
genomics are specialized scenarios that may need extensions at a later date.
This Use Case has five scenarios:





Scenario 1:
Scenario 2:
Scenario 3:
Scenario 4:
Scenario 5:
Electronic Ordering of a New or Scheduled Laboratory Test(s)
Electronic Ordering of an Add-On Laboratory Test(s)
Requesting Status on a Previously Placed Laboratory Order
Requesting the Cancellation of a Previously Placed Laboratory Order
A Laboratory Cancels a Previously Placed Laboratory Order
3.1 Background
The LOI Initiative requires and supports information interchange. Messaging and vocabulary standards
supporting lab data exchange exist but due to the high degree of allowable variation implementation of
laboratory interfaces is time consuming and costly. This Initiative will leverage both the CHCF ELINCs
Orders and the Laboratory Results Interface work when defining the LOI Use Case and Functional
Requirements. It will also align the Laboratory Results Interface IG with the Laboratory Orders Interface
IG.
3.2 In Scope





Electronic ordering of laboratory tests and/or panels in the ambulatory setting for the US Realm.
Defining the core data elements required for ordering ambulatory laboratory tests and/or
panels.
Defining the set of information from the laboratory order that may be included in the
corresponding test result (echo back). The implementation guide should accommodate, though
not require, standard practice when it exceeds the minimal regulatory requirements.
Laboratory Order Placer (i.e., Ordering Provider) may designate other non-order placers to
receive results.
Harmonization of data elements that are used in both laboratory orders and results.
3.3 Out of Scope

Electronic ordering of laboratory tests and/or panels in an acute care setting, internally within a
laboratory, referral orders placed between laboratories, and laboratory orders outside the US
Realm.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders









Concepts related to: order queues, clearing houses, or other transport-level mechanisms and
protocols that may be used to transfer or hold laboratory orders for later retrieval by a
laboratory selected to perform the laboratory service.
Reflex tests initiated by the Laboratory in response to prior test results.
Multi-order status requests (for one patient or multiple patients).
Advanced error messages related to application or transport.
Laboratory orders not transmitted electronically
Secondary uses of laboratory order data.
The human mechanisms that are required to resolve any differences between the order
identifier and the specimen label.
Physical transport level confirmations.
Interactions between the LIS and EHR System for Add-On orders beyond the transmission of the
order (to address scenarios such as insufficient specimen or late arrivals of Add-On orders).
3.4 Communities of Interest
Member of Communities of Interests
Patient
Care Coordinators
Clinicians
Provider
Laboratories
Provider Organizations
Standards Organizations
7/26/2012
Working Definition
Members of the public who require healthcare services from
ambulatory, emergency department, physician’s office,
and/or the public health agency/department.
Individuals who support clinicians in the management of
health and disease conditions. These can include case
managers and others.
Healthcare providers with patient care responsibilities,
including physicians, laboratory personnel, advanced practice
nurses, physician assistants, nurses, pharmacists, and other
licensed and credentialed personnel involved in treating
patients.
An individual clinician in a care delivery setting who delivers
care to the patient and in that role orders laboratory tests in
this Use Case.
A laboratory is defined as any facility which performs
laboratory testing on specimens derived from humans for the
purpose of providing information for the diagnosis,
prevention, treatment of disease or impairment, or
assessment of health.
Organizations that are engaged in or support the delivery of
healthcare to include Hospital Ambulatory Centers and
Provider Practices.
Organizations whose purpose is to define, harmonize and
integrate standards that will meet clinical and business needs
for sharing information among organizations and systems.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Member of Communities of Interests
Electronic Health Record/Personal
Health Record Vendors
Federal/ other regulating Agencies
Health Information Exchange (HIE)
Public Health Organization (State/Local)
Working Definition
Vendors which provide specific EHR/PHR solutions to
clinicians such as software applications and software services.
These suppliers may include developers, providers, resellers,
operators, and others who may provide these or similar
capabilities.
Organizations within the federal government that deliver,
regulate, or provide funding for health and health care.
HIE is defined as the mobilization of healthcare information
electronically across organizations within a region,
community or hospital system.
An agency that performs or conducts one or more of the
following essential functions that characterize public health
programs, services, or activities: (a) monitor health status to
identify community health program; (b) diagnose and
investigate health programs, and health hazards in the
community.
Table 1: Communities of Interest
4.0 Value Statement
Laboratory orders interfaces automate the electronic communication of test order information between
EHR Systems and LIS. To date, there is no consistent implementation guidance available for electronic
laboratory order interfaces across the ambulatory setting. Implementation guidance that defines the
communication (the message structure, data elements, and vocabularies) of laboratory orders between
an EHR System and an LIS, based on accepted industry standards, can:




Improve care delivery and clinical outcomes through the tight coupling of order and result
messages;
Reduce implementation efforts and costs;
Reduce on-going support and maintenance-related activities and costs; and
Provide an extensible foundation for use in acute care and public health settings.
5.0 Use Case Assumptions




Providers (Order Placers) securely access clinical information through an EHR system.
Users have a need to exchange laboratory order data between ambulatory care EHRs and
laboratories.
EHR system has the ability to manage a laboratory order, including generating the laboratory
requisition, sending it to a laboratory, and monitoring/tracking of the status of the laboratory
order.
An EHR system capable of generating an order electronically should be capable of receiving and
processing acknowledgements, results and cancellations.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders





An LIS is capable of receiving and processing acknowledgements.
The Laboratory is capable of receiving laboratory orders electronically and in standardized
structured format.
The EHR System and LIS both use data models that include discrete representations of patients,
clinician end-users, laboratory requisitions, laboratory orders (which include tests and panels),
and laboratory test results (minimally at the level of individual analytes).
LRI IG and the LOI IG will be kept in sync with one another. A laboratory that receives an order
using LOI should be capable of responding with LRI.
Appropriate security and transport protocols, patient identification methodology, order
identification methodology, patient consent, privacy and security procedures, coding,
vocabulary, error handling, and normalization standards have been agreed to by all relevant
participants.
 Legal and governance issues regarding data access authorizations, data ownership, and data
use are in effect.
 Established network and policy infrastructure to enable consistent, appropriate, and
accurate information exchange across provider systems, data repositories and
locator services. This includes, but is not limited to:
 Methods to identify and authenticate users;
 Methods to identify and determine Providers of care;
 Methods to enforce data access authorization policies;
 Methods to ensure the veracity of data;
 Detailed audit trails are kept as necessary by all participating systems.
 Security and privacy policies, procedures and practices are commonly implemented
to support acceptable levels of patient privacy and security; i.e. HIPAA, HITECH and
EHR certification criteria.
6.0 Pre-Conditions






The Provider (Order Placer) has performed all of the necessary checks for medical necessity,
insurance eligibility and any needed pre-authorizations.
After a Provider (Order Placer) enters a laboratory order, the EHR system generates an
electronic laboratory requisition containing pertinent information as well as appropriate
identifiers, such as patient, order, and specimen.
Performing Laboratory’s test compendium has been entered (manual or automated) into the
EHR system.
Cancellation requests for laboratory orders are accurately captured and properly formatted
within the EHR System.
Status requests on laboratory orders are accurately captured and properly formatted within the
EHR System, if trading partners agree to support status requests.
The transmitted message includes appropriate billing information.
7/26/2012
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders

Specimen(s) are appropriately labeled, meaning that the specimen can be linked to the order.
7.0 Post Conditions









Laboratory orders are successfully transmitted electronically from the Provider’s (Order Placer’s)
EHR System to the Laboratory’s LIS. Receiving Laboratory electronically transmits
acknowledgement of receipt of the laboratory requisition. The received order may be placed
into an electronic queue for further processing depending on laboratory workflow (although
order queues are out of scope for this Use Case). [Scenario 1]
Specimen(s) associated with the laboratory order are collected and, if necessary, transported to
the laboratory.[Scenarios 1, 2]
Laboratory processes the laboratory order and associated specimen(s). This step may include
retrieval and processing of laboratory orders from a queue or list of received orders. Order
queues may be used in the LIS to hold electronic laboratory orders until associated specimens
are received and the appropriate patient matching and registration occur (although order
queues are out of scope for this Use Case). After patient matching and registration, the
electronic order may be electronically processed in the LIS. [Scenario 2]
If the laboratory order and specimen(s) are satisfactory for testing the laboratory will perform,
or attempt to perform, the test(s). [Scenarios 1, 2]
The laboratory test result is obtained, entered/released in the LIS, and sent to the Provider’s
(Order Placer’s) EHR System. This is covered within the Laboratory Results Interface Use Case.
[Scenarios 1, 2]
The Provider’s (Order Placer’s) EHR System has electronically received the laboratory order
status. [Scenario 3]
Successfully transmit laboratory order cancellation from the Provider’s (Order Placer’s) EHR
system to the Laboratory’s LIS. [Scenario 4]
The Laboratory’s LIS has electronically received the laboratory order cancellation request.
[Scenario 4]
The Laboratory’s cancellation of an order, or part of an order, has been electronically received
by the Provider’s (Order Placer’s) EHR System. [Scenario 5]
8.0 Actors and Roles
Actor
Provider
7/26/2012
System
EHR System
Role
Order Placer, Order Sender, AddOn Placer, Add-On Sender,
Cancellation Request Sender,
Cancellation Receiver
11
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Actor
Laboratory
System
Laboratory Information System
Role
Order Receiver, Specimen
Receiver, Order Filler,
Cancellation Request Receiver,
Cancellation Sender, Add-On
Receiver
Table 2: Actors and Roles
9.0 Use Case Diagrams
Figure 1: Use Case Diagram
7/26/2012
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Figure 2: Context Diagram
10.0 Scenario 1 – Electronically Ordering a New or Scheduled Laboratory
Test(s)
Using an EHR System, a Provider (Order Placer) orders one or more new laboratory tests or scheduled
laboratory tests1 to be performed by a laboratory.
10.1 User Story
A Provider (Order Placer) enters into an ambulatory EHR system a new or scheduled laboratory order
and indicates whether or not they would like to receive ongoing status updates on the order. Scheduled
orders enable Providers (Order Placers) to order laboratory tests and/or panels for a patient, which are
scheduled to be performed at a future date. A laboratory requisition is generated for the new or
scheduled laboratory order in electronic form and is electronically transmitted to the selected
Laboratory. A paper requisition matching the electronic laboratory requisition may also be generated
and delivered to the Laboratory (by the patient, via fax, or along with the collected specimen). An
electronic notification will be sent from the Laboratory (Order Filler) to the Provider (Order Placer)
acknowledging that the laboratory requisition has been received.
The information from laboratory requisition is electronically captured by the Laboratory. The receiving
Laboratory may cross-check details of the order using the delivered paper requisition and/or may
request additional information for the patient.
After the specimen(s) has been collected at either the Provider, testing center, or at the Laboratory and,
if necessary, shipped or delivered to the Laboratory, the Laboratory receives and processes the
specimen(s). The Laboratory (Order Filler) performs or attempts to perform the test(s). If the Provider
(Order Placer) requests to receive status updates within the original order, the Laboratory will
automatically generate and send the updates as the order goes through each of the processing steps2.
1
This includes future tests.
The implications of a status change will be developed as part of the technical specification and are therefore not
shown in full in the Alternative Flow and associated Activity Diagram.
2
7/26/2012
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
As the test is being resulted, a report is sent back electronically in a standardized, structured format (use
of the LRI IG is recommended).
10.2 Activity Diagram – Base Flow
Figure 3: Scenario 1 Activity Diagram - Base Flow
10.2.1 Base Flow Table
Step #
1
Actor
Provider
Role
Order Placer
Event/Description
Provider enters a New
or Scheduled Laboratory
order into an
Ambulatory EHR System
2
Provider
Order
Sender
3
Laboratory
Order
Receiver
EHR System Generates
and Sends Laboratory
Requisition
LIS Receives Laboratory
Requisition
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Inputs
Patient
Information
and Laboratory
Order
Information
Laboratory
Order
Outputs
Laboratory Order
Laboratory
Requisition
Laboratory Order
Laboratory
Requisition
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Step #
4
Actor
Laboratory
Role
Order
Receiver
5
Provider
Order
Sender
6
Laboratory
Specimen
Receiver
Event/Description
LIS Sends
Acknowledgement
Receipt to EHR that the
Requisition was
Received
EHR System Receives
Acknowledgement from
LIS
Laboratory Receives the
Specimen
Inputs
Laboratory
Requisition
Outputs
Requisition
Acknowledgement
Acknowledgem
ent of
Requisition
Laboratory
Specimen
Requisition
Acknowledgement
Laboratory
Specimen
Table 3: Scenario 1 Base Flow
10.3 Activity Diagram - Alternative Flow (Receiving Status Updates)
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Figure 4: Scenario 1 Activity Diagram - Alternative Flow
10.3.1 Alternative Flow Table – Receiving Status Updates
Step #
1
Actor
Provider
Role
Order Placer
2
Provider
Order
Sender
3
Laboratory
4
Laboratory
Order
Receiver
Order
Receiver
5
Provider
Order
Sender
6
Laboratory
7
Laboratory
8
Provider
Specimen
Receiver
Order
Receiver
Order
Sender
9
Laboratory
Order
Receiver
Event/Description
Provider Enters a New
or Scheduled Laboratory
Order into an
Ambulatory EHR System
and Indicates that they
would like to Receive
Status Updates on the
Order
EHR System Generates
and Sends Laboratory
Requisition
LIS Receives Laboratory
Requisition
LIS Sends
Acknowledgement
Receipt to EHR that the
Requisition was
Received
EHR System Receives
Acknowledgement from
LIS
Laboratory Receives the
Specimen
LIS Generates and Sends
Laboratory Order Status
EHR System Receives
Laboratory Order Status
from LIS
Laboratory Results are
Finalized
Inputs
Patient
Information
and Laboratory
Order
Information
Outputs
Laboratory Order
Laboratory
Order
Laboratory
Requisition
Laboratory
Requisition
Laboratory
Requisition
Laboratory Order
Acknowledgem
ent of
Requisition
Laboratory
Specimen
Laboratory
Order Status
Laboratory
Order Status
Requisition
Acknowledgement
Laboratory
Order Status
Laboratory Results
Requisition
Acknowledgement
Laboratory
Specimen
Laboratory Order
Status
Laboratory Order
Status
Table 4: Scenario 1 Alternative Flow
10.4 Functional Requirements
10.4.1 Information Interchange Requirements
Initiating
System
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(describes
action)
Information
Interchange
Requirement Name
(describes
action)
Receiving System
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Initiating
System
(describes
action)
Electronic
Health Record
System
Laboratory
Information
System
Laboratory
Information
System
Send
Send
Send
Information
Interchange
Requirement Name
Laboratory Test
Requisition
(describes
action)
Receiving System
Receive
Laboratory Information
System
Acknowledgement for
Received Laboratory
Requisition
Laboratory Order Status
Receive
Electronic Health Record
System
Receive
Electronic Health Record
System
Table 4: Scenario 1 Information Interchange Requirements
10.4.2 System Requirements
System
Electronic Health Record System
Laboratory Information System
Laboratory Information System
Laboratory Information System
Electronic Health Record System
System Requirement
Generate an Electronic Laboratory Requisition with
Standardized Structured Data
Process Electronic Laboratory Requisition
Link Laboratory Requisition to Appropriate
Laboratory Results
Generate and Send Laboratory Order Status
Process Laboratory Order Status
Table 5: Scenario 1 System Requirements
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
10.5 Sequence Diagram
Figure 5: Scenario 1 Sequence Diagram
11.0 Scenario 2 - Electronically Ordering an Add- On Laboratory Test(s)
Using an EHR System, a Provider (Order Placer) adds one or more additional tests to a previously
transmitted test requisition.
11.1 User Story
Using an ambulatory EHR system, a Provider (Order Placer) enters one or more additional tests be added
to a previously transmitted laboratory requisition. A laboratory requisition is generated for the add-on
laboratory order in electronic form and is electronically transmitted to the selected Laboratory. A paper
requisition matching the electronic test requisition may also be generated and delivered to the
Laboratory (by the patient, via fax, or along with the collected specimen). The Laboratory (Order Filler)
matches the placer group number/instance ID from the add-on order with the original order. An
electronic notification will be sent from the Laboratory (Order Filler) to the Provider (Order Placer)
acknowledging that the requisition has been received.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
The information from the electronic laboratory requisition is electronically captured by the Laboratory.
The receiving Laboratory may cross-check details of the order using the delivered paper requisition
and/or may request additional information for the patient.
The Laboratory (Order Filler) performs or attempts to perform the test(s), and a result report is sent
back electronically in a standardized, structured format (use of the LRI IG is recommended). The test
result report may be combined with the result report for the original tests, or may be returned as a
separate report.
11.2 Activity Diagram
Figure 6: Scenario 2 Activity Diagram
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
11.2.1 Base Flow
Step # Actor
1
Provider
Role
Add-On
Placer
Event/Description
Provider enters an addon laboratory order into
an ambulatory EHR
System
EHR System Generates
and Sends Laboratory
Requisition
LIS Receives Laboratory
Requisition
LIS Matches placer
group number/instance
ID from add-on order to
that of the original
requisition
LIS Sends
Acknowledgement
Receipt to EHR that the
Requisition was
Received
EHR System Receives
Acknowledgement from
LIS
2
Provider
Add-On
Sender
3
Laboratory
4
Laboratory
Add-On
Receiver
Add-On
Receiver
5
Laboratory
Add-On
Receiver
6
Provider
Add-On
Sender
Inputs
Patient
Information
and Laboratory
Order
Information
Laboratory
Order
Outputs
Laboratory Order
Laboratory
Requisition
Laboratory Order
Laboratory
Requisition
Laboratory Order
Add-On and
Original
Requisitions
Laboratory
Requisition
Requisition
Acknowledgement
Acknowledgem
ent of
Requisition
Requisition
Acknowledgement
Table 6: Scenario 2 Base Flow
11.3 Functional Requirements
11.3.1 Information Interchange Requirements
Initiating
(describes
Information
System
action)
Interchange
Requirement Name
Electronic
Send
Laboratory Requisition
Health Record
System
Laboratory
Send
Acknowledgement for
Information
Received Laboratory
System
Requisition
(describes
action)
Receiving System
Receive
Laboratory Information
System
Receive
Electronic Health Record
System
Table 7: Scenario 2 Information Interchange Requirements
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
11.3.2 System Requirements
System
Electronic Health Record System
Laboratory Information System
Laboratory Information System
System Requirement
Generate an Electronic Laboratory Test Requisition
with Standardized Structured Data
Match Add-On Order with Original Requisition
Process Electronic Laboratory Test Requisition and
Link it to Appropriate Laboratory Results
Table 8: Scenario 2 System Requirements
11.4 Sequence Diagram
Figure 7: Scenario 2 Sequence Diagram
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
12.0 Scenario 3 – Requesting Status on a Previously Placed Laboratory
Order
The Provider (Order Placer) requests via the EHR the current status of a previously placed, single
laboratory order.
Note: Although the laboratory industry currently may not have the functionality to support this Scenario,
it was deemed to be a valuable addition to the Laboratory Orders Use Case. When using this document
to create implementation guidance, this Scenario can be considered optional.
12.1 User Story
A Provider (Order Placer) wishes to learn the status of a previously placed laboratory order. He/she logs
into his/her EHR system, selects a previously ordered laboratory test and requests information from the
performing Laboratory (Order Filler) related to the current status of the order if not yet available in the
EHR System. A message is electronically generated with the status request and sent to the Laboratory
handling the original laboratory order request. The Laboratory notifies the Provider (Order Placer) when
the request is received. The Laboratory then determines the status of the laboratory order and
communicates the current status to the Provider (Order Placer). Upon receiving the status of the order
the Provider sends an acknowledgement to the Laboratory.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
12.2 Activity Diagram
Figure 8: Scenario 3 Activity Diagram
12.2.1 Base Flow
Step # Actor
1
Provider
Role
Order Placer
2
Provider
Order Placer
3
Laboratory
Order Filler
7/26/2012
Event/Description
A laboratory order is
selected via an EHR
System and a status of
that order is requested
EHR System Sends
Status Request
LIS Receives Status
Request
Inputs
Clinical
Laboratory
Order
Outputs
Status Request
Status Request
Status Request
Status Request
Status Request
23
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Step #
4
Actor
Laboratory
Role
Order Filler
5
Provider
Order Placer
6
Laboratory
Order Filler
7
Laboratory
Order Filler
8
Provider
Order Placer
9
Provider
Order Placer
10
Laboratory
Order Filler
Event/Description
LIS Sends
Acknowledgement to
EHR that the Status
Request was Received
EHR System receives
Status Request
Acknowledgement
Laboratory Determines
Laboratory Order Status
LIS Sends Laboratory
Order Status
EHR System Receives
Laboratory Order Status
EHR System Sends
Acknowledgement to
the LIS that Laboratory
Order Status Was
Received
LIS receives
Acknowledgement from
EHR System
Inputs
Status Request
Outputs
Status Request
Acknowledgement
Status Request
Acknowledgem
ent
Status Request
Status Request
Acknowledgement
Laboratory Order
Status
Laboratory Order
Status Response
Laboratory Order
Status
Laboratory
Order Status
Laboratory
Order Status
Response
Laboratory Test Acknowledgement
Order Status
of Laboratory Order
Notification
Status
Acknowledgem
ent of
Laboratory
Order Status
Laboratory Order
Status
Acknowledgement
Table 9: Scenario 3 Base Flow
12.3 Functional Requirements
12.3.1 Information Interchange Requirements
Initiating
(describes
Information
System
action)
Interchange
Requirement Name
Electronic
Send
Laboratory Order Status
Health Record
Request
System
Laboratory
Send
Acknowledgement of
Information
Laboratory Order Status
System
Request
Laboratory
Send
Notification of
Information
Laboratory Order Status
System
Electronic
Send
Acknowledgement of
Health Record
Laboratory Order Status
System
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(describes
action)
Receiving System
Receive
Laboratory Information
System
Receive
Electronic Health Record
System
Receive
Electronic Health Record
System
Receive
Laboratory Information
System
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Table 10: Scenario 3 Information Interchange Requirements
12.3.2 System Requirements
System
EHR
EHR
LIS
System Requirement
Generate Laboratory Order Status Request
Display the Status to the Provider
Process Status Request and Send Electronic Messages
that Report the Status and Results of a Laboratory
Order
Table 11: Scenario 3 System Requirements
12.4 Sequence Diagram
Figure 9: Scenario 3 Sequence Diagram
13.0 Scenario 4 – Requesting the Cancellation of a Previously Placed
Laboratory Order
The Provider (Order Placer) determines that one or more orders from a previously transmitted
electronic laboratory requisition needs to be cancelled and requests via the EHR that the Laboratory
cancel the performance of the laboratory order(s).
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
13.1 User Story
A Provider (Order Placer) logs into his/her EHR system, selects a previously ordered laboratory test
and/or panel and cancels the laboratory order. A message is electronically generated with the request
for order cancellation and sent to the Laboratory (Order Filler) handling the original laboratory order
request. In some cases, it will not be possible for the Laboratory to cancel an order when requested by
the Provider (Order Placer) [e.g., the laboratory may have already begun testing or results are already
available]. Hence, a record of the laboratory order should remain in the ordering EHR system until the
cancellation request has been acknowledged by the Laboratory.
Upon receiving the cancellation request, the Laboratory sends an electronic notification to the ordering
EHR system acknowledging receipt of the request. This notification does not indicate actual cancellation
of the laboratory order, only acknowledgement that the request has been successfully received. If the
laboratory order is subsequently cancelled, the Laboratory will send a separate electronic notification to
the Provider (Order Placer) indicating cancellation of the laboratory order.
If the Laboratory is not able to comply with the cancellation request, then the Laboratory will continue
to process the sample and obtain results as originally ordered by the Provider (Order Placer). The
Laboratory will send the laboratory results for the ordered test in compliance with the policies and
procedures of the performing Laboratory. This transmission of results will serve as the only indication to
the Provider that the Laboratory was unable to execute the cancellation request.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
13.2 Activity Diagram
Figure 10: Scenario 4 Activity Diagram
13.2.1 Base Flow
Step # Actor
1
Provider
7/26/2012
Role
Cancellation
Request
Sender
Event/Description
A laboratory order is
selected and cancelled
via an EHR System.
Inputs
Laboratory
Order
Outputs
Cancellation Request
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Step #
2
Actor
Provider
3
Laboratory
4
Laboratory
5
Provider
6
Event/Description
EHR System Sends
Cancellation Request
Inputs
Cancellation
Request
Outputs
Cancellation Request
LIS Receives
Cancellation Request
Cancellation
Request
Cancellation Request
Cancellation
Request
Cancellation Request
Acknowledgement
Cancellation
Request
Sender
LIS Sends
Acknowledgement to
EHR that the
Cancellation Request
was Received
EHR System receives
Cancellation Request
Acknowledgement
Cancellation Request
Acknowledgement
Laboratory
Cancellation
Request
Receiver
Laboratory Approves
and Confirms
Cancellation Request
Cancellation
Request
Acknowledge
ment
Cancellation
Request
7
Laboratory
Cancellation
Request
Receiver
Clinical Laboratory
Order is Cancelled
8
Laboratory
Cancellation
Request
Receiver
LIS Sends Notification of
Cancelled Laboratory
Order
9
Provider
Cancellation
Request
Sender
EHR System Receives
Cancelled Laboratory
Order Notification
10
Provider
Cancellation
Request
Sender
11
Laboratory
Order Filler
EHR System Sends
Acknowledgement to
the LIS that the
Cancelled Laboratory
Order Notification Was
Received
LIS Receives
Acknowledgement from
the EHR System
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Role
Cancellation
Request
Sender
Cancellation
Request
Receiver
Cancellation
Request
Receiver
Approval and
Confirmation
to Cancel
Laboratory
Order
Confirmation
of Cancelled
Laboratory
Order
Cancelled
Laboratory
Order
Notification
Cancelled
Laboratory
Order
Notification
Acknowledge
ment of
Cancelled
Laboratory
Order
Notification
Approval and
Confirmation to
Cancel Laboratory
Order
Confirmation of
Cancelled Laboratory
Order
Cancelled Laboratory
Order Notification
Cancelled Laboratory
Order Notification
Acknowledgement of
Cancelled Laboratory
Order Notification
Laboratory Order
Cancellation
Acknowledgement
28
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Table 12: Scenario 4 Base Flow
13.3 Functional Requirements
13.3.1 Information Interchange Requirements
Initiating
System
(describes
action)
Electronic
Health Record
System
Laboratory
Information
System
Laboratory
Information
System
Electronic
Health Record
System
Send
Send
Send
Send
Information
Interchange
Requirement Name
Laboratory Order
Cancellation Request
(describes
action)
Receiving System
Receive
Laboratory Information
System
Acknowledgement of
Laboratory Order
Cancellation Request
Notification of
Laboratory Order
Cancellation
Acknowledgement of
Laboratory Order
Cancellation
Notification
Receive
Electronic Health Record
System
Receive
Electronic Health Record
System
Receive
Laboratory Information
System
Table 13: Scenario 4 Information Interchange Requirements
13.3.2 System Requirements
System
EHR
LIS
System Requirement
Generate Laboratory Order Cancellation Request
Process Order Cancellation Request
Table 14: Scenario 4 System Requirements
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
13.4 Sequence Diagram
Figure 11: Scenario 4 Sequence Diagram
14.0 Scenario 5 –A Laboratory Cancels a Previously Placed Laboratory
Order
The Laboratory (Order Filler) may cancel laboratory orders and send a cancellation notification message
to the Provider (Order Placer) because it is unable to perform the laboratory order.
14.1 User Story
A Provider (Order Placer) enters into an ambulatory EHR system a laboratory order. A laboratory
requisition is generated for the new or scheduled laboratory order in electronic form and is
electronically transmitted to the selected Laboratory. A paper requisition matching the electronic
laboratory requisition may also be generated and delivered to the Laboratory (by the patient, via fax, or
along with the collected specimen). An electronic notification will be sent from the Laboratory (Order
Filler) to the Provider (Order Placer) acknowledging the laboratory requisition has been received.
The information from the electronic requisition is electronically captured by the Laboratory. The
receiving Laboratory may cross-check details of the order using the delivered paper order and/or may
request additional information for the patient.
The Laboratory may not be able to process the laboratory order for a number of reasons, including, but
not limited to:
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders








specimen was not collected (e.g., patient did not present at a phlebotomy center to have blood
drawn);
specimen was collected, but did not arrive at the laboratory;
specimen was compromised during transport(e.g., glass tubes containing the specimen may
have broken during transport);
incorrect specimen to perform any of the tests (e.g., receive urine specimen when blood is
required);
receiving a contaminated specimen (e.g., specimen transported to the laboratory at the wrong
temperature);
specimen is misidentified (e.g., specimens are transported on ice and the labels identifying the
specimens come off);
laboratory accident;
insufficient specimen volume.
If the Laboratory is unable to perform a given laboratory order within a laboratory requisition, the
Laboratory may electronically cancel one or more of the laboratory orders included within the
requisition. The electronic cancellation is sent to the Provider (Order Placer) and the Provider's EHR
system acknowledges the order cancellation.
Note: If there is a complete requisition with appropriate and sufficient specimen to perform any of the
ordered procedures, the cancellation of one or more components requires a results report with the
rationale for why the testing was discontinued or not performed.
Additional reasons for a Laboratory cancelling a test can be found in Appendix B.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
14.2 Activity Diagram
Figure 12: Scenario 5 Activity Diagram
14.2.1 Base Flow
Step # Actor
1
Provider
Role
Order Placer
Event/Description
Provider enters a new
or scheduled laboratory
order into an
ambulatory EHR System
EHR System Generates
and Sends Laboratory
Requisition to LIS
LIS Receives Laboratory
Requisition
2
Provider
Order
Sender
3
Laboratory
Order
Receiver
7/26/2012
Inputs
Patient
Information
and Laboratory
Order
Information
Laboratory
Order
Outputs
Laboratory Order
Laboratory
Requisition
Laboratory
Requisition
Laboratory
Requisition
32
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Step #
4
Actor
Laboratory
Role
Order
Receiver
Event/Description
LIS Sends
Acknowledgement
Receipt to EHR that the
Requisition was
Received
Laboratory is unable to
Complete a given
Laboratory Order within
a Laboratory Requisition
Inputs
Laboratory
Requisition
Outputs
Acknowledgement
5
Laboratory
Order Filler
Patient
Information
and Laboratory
Order
Information &
Laboratory
Specimen
Unable to Perform a
given Laboratory
Order within a
Laboratory
Requisition Proceed
to Step 6, Able to
Perform one or
more Laboratory
Orders, Proceed to
Step 8
6
Laboratory
Cancellation
Sender
LIS Sends Cancellation
Notification
Order Cancellation
Notification
Provider
Cancellation
Receiver
EHR Acknowledges
Order Cancellation
Laboratory
Order Filler
Results for Laboratory
Orders that have been
completed obtained and
entered/released into
the LIS
Order
Cancellation
Details
Order
Cancellation
Notification
Laboratory Test
Result
7
8
Acknowledgement
Laboratory Test
Result
Table 15: Scenario 5 Base Flow
14.3 Functional Requirements
14.3.1 Information Interchange Requirements
Initiating
(describes
Information
System
action)
Interchange
Requirement Name
Laboratory
Send
Cancellation Notification
Information
System
Electronic
Send
Acknowledgment (this
Health Record
should include
System
information on the
receipt of the
transmission and
7/26/2012
(describes
action)
Receiving System
Receive
Electronic Health Record
System
Receive
Laboratory Information
System
33
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Initiating
System
(describes
action)
Information
Interchange
Requirement Name
relevant processing
details)
(describes
action)
Receiving System
Table 16: Scenario 5 Information Interchange Requirements
14.3.2 System Requirements
System
System Requirement
LIS
EHR
EHR
Generate Laboratory Order Cancellation Notification
Receive Cancellation Notification
Process Cancellation Notification
Table 17: Scenario 5 System Requirements
14.4 Sequence Diagram
Figure 13: Scenario 5 Sequence Diagram
15.0 Risks, Issues and Obstacles
There is a lack of harmonization among data interoperability standards including vocabulary, laboratory
and other messaging standards.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
The Information Exchange workgroup identified many systematic issues related to standardization of
electronic laboratory transactions. These issues were presented at the December 19, 2009 Health
Information Technology Policy Committee meeting and have been expanded on within this section.
Weak market incentives prevent rapid growth in standards-based laboratory interfacing; interfaces still
not replicable and are thus time-consuming and costly.




Though intended to address the most commonly ordered tests, this Use Case does not address
the full menu of all tests available from all laboratories throughout the United States.
Laboratory interfaces cost $5-$25K each to set up.
Meaningful Use does not provide financial incentives to the Laboratories, which bear the cost of
most interface development with EHR Systems.
Interface development and testing to meet accreditation requirements can take months, which
lengthens interface time and increases cost.
High degree of allowable variation in current messaging and vocabulary standards makes interfacing
time-consuming and costly.









Transport, messaging and vocabulary standards exist but because of the variety of available
standards interoperability is difficult to achieve. Even though HL7 2.5.1 was released in 2007, it
is still not widely used.
Allowable variations in HL7 standards hinder cost effective interface development (e.g. high
number of optional fields).
There are different expectations for what is included in a laboratory interface which pose a
barrier to the interoperability of laboratory orders from ambulatory care environments.
Universal Laboratory Order codes (using LOINC terminology) and SNOMED are not widely
adopted.
Public perception that standardized vocabularies such as LOINC will replace their local coding
systems is misconstrued.
Conversion to HL7 2.5.1 and LOINC would require investment by most hospitals, providers,
laboratories and IT System developers for interface development and upgrading of systems.
There is limited adoption of standard automated ways to update compendiums and upload
order sets from different laboratories into the EHR; usually happens as a manual process.
Limits in the process/workflow/technology within the laboratory system hinder the ability to
echo the original requisition (order) identifier and/or patient identifier(s) back to placer in the
result.
When an interface is initiated between a laboratory environment and any external (to the
laboratory) entity, the Laboratory is required to verify that all the CLIA required elements were
transmitted accurately and timely to the authorized person or their designated
agent. Verification is performed initially, upon changes, periodically thereafter, and/or at
frequencies specified by the laboratory’s accreditor (if applicable).
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders




Laboratories are required to test interfaces periodically for inspection and accreditation
purposes, including the capture of screen shots of the end user receipt of each orderable
laboratory test in their laboratory test catalog. The resources required for this testing will need
to be extended to retest existing interfaces.
An EHR may feature orderable tests from several laboratories in its menu. The EHR will be
responsible for delivering each order to the correct destination. Each laboratory connection will
need to be tested individually.
Each laboratory may have multiple local codes in place for a particular laboratory order (and
therefore would have the same LOINC code) to satisfy business/operational rules and the needs
of ordering providers. The use of the same LOINC code associated with multiple laboratory
order codes will not adequately distinguish which local code should actually be ordered.
In some circumstances, it is convenient for a provider to order lab tests for a patient that are
scheduled to occur at a future date. We refer to such tests as scheduled orders. Details
regarding the length of time for which a scheduled order can be sent in advance of the
performance of a test and the span of time in which a scheduled order remains valid shall be
negotiated between the lab and the EHR or ordering provider.
16.0 Dataset Requirements
The following section was developed to support the aforementioned Use Case requirements. These
selections are meant to act as a starting point for subsequent specification and Implementation Guide
development, and it is understood that these efforts may add to, subtract from, and/or otherwise refine
this list.
Message Section
Data Element
Message Header (MSH)
Field Separator
Encoding Characters
Sending Application
Sending Facility
Receiving Application
Receiving Facility
Date/Time Of Message
Security
Message Type
Message Control ID
Processing ID
Version ID
Accept Acknowledgment Type
Application Acknowledgment Type
Message Profile Identifier
Acknowledgement Code
Message
Acknowledgement
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Additional Notes
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Message Section
Data Element
Additional Notes
(MSA)
Error (ERR)
Patient Identification
(PID)
Patient Visit (PV1)
Patient Visit – Additional
Information (PV2)
Message Control ID
Error Location
HL7 Error Code
Severity
Diagnostic Information
User Message
Help Desk Contact Point
Set ID – PID
Patient Identifier List
Patient Name
Date/Time of Birth
Administrative Sex
Race
Patient Address
Phone Number – Home
Phone Number –Business
Primary Language
Marital Status
Religion
Patient Account Number
Mother’s Identifier
Ethnic Group
Birth Place
Multiple Birth Indicator
Birth Order
Citizenship
Veterans Military Status
Patient Death Date and Time
Patient Death Indicator
Identity Reliability Code
Last Update Date/Time
Last Update Facility
Patient Class
Financial Class
Visit Description
Employment Illness Related Indicator
Previous Treatment Date
First Similar Illness Date
Recurring Service Code
Expected Surgery Date and Time
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Message Section
Common Order Segment
(ORC)
Observation Request
(OBR)
Data Element
Additional Notes
Newborn Baby Indicator
Baby Detained Indicator
Admission Level of Care Code
Precaution Code
Patient Condition Code
Patient Status Effective Date
Order Control
Placer Order Number
Filler Order Number
Placer Group Number
Order Status
Response Flag
Parent Order
Date/Time of Transaction
Entered By
Verified By
Ordering Provider
Enterer's Location
Call Back Phone Number
Order Effective Date/Time
Order Control Code Reason
Entering Organization
Action By
Advanced Beneficiary Notice Code
Ordering Facility Name
Ordering Facility Address
Ordering Facility Phone Number
Ordering Provider Address
Order Status Modifier
Advanced Beneficiary Notice Override Reason
Confidentiality Code
Order Type
Enterer Authorization Mode
Parent Universal Service Identifier
Set ID - OBR
Placer Order Number
Filler Order Number
Universal Service Identifier
Observation Date/Time
Observation End Date/Time
Collector Identifier
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Message Section
Timing/Quantity (TQ1)
Observation/Result
(OBX)
Specimen (SPM)
7/26/2012
Data Element
Additional Notes
Specimen Action Code
Danger Code
Relevant Clinical Information
Ordering Provider
Order Callback Phone Number
Placer Field 1
Placer Field 2
Filler Field 1
Filler Field 2
Results Rpt/Status Change – Date/Time
Result Status
Result Copies To
Reason for Study
Technician
Placer Supplemental Service Information
Filler Supplemental Service Information
Medically Necessary Duplicate Procedure
Reason
Result Handling
Parent Universal Service Identifier
Set ID - TQ1
Quantity
Repeat Pattern
Explicit Time
Relative Time and Units
Service Duration
Start date/time
End date/time
Priority
Condition text
Text instruction
Total occurrences
Set ID – OBX
Value Type
Observation Identifier
Observation Sub-ID
Observation Value
Units
Observation Result Status
Date/Time of the Observation
Set ID – SPM
Specimen ID
39
Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Message Section
Next of Kin (NK1)
Insurance (IN1)
7/26/2012
Data Element
Additional Notes
Specimen Parent IDs
Specimen Type
Specimen Type Modifier
Specimen Additives
Specimen Collection Method
Specimen Source Site
Specimen Source Site Modifier
Specimen Collection Site
Specimen Collection Amount
Specimen Description
Specimen Handling Code
Specimen Risk Code
Specimen Collection Date/Time
Specimen Received Date/Time
Specimen Availability
Specimen Reject Reason
Specimen Quality
Specimen Appropriateness
Specimen Condition
Specimen Current Quantity
Number of Specimen Containers
Container Type
Set ID - NK1
Name
Relationship
Address
Phone Number
Contact Role
Organization Name - NK1
Primary Language
Set ID - IN1
Insurance Plan ID
Insurance Company ID
Insurance Company Name
Insurance Company Address
Insurance Co Phone Number
Group Number
Insured's Group Emp ID
Insured's Group Emp Name
Plan Expiration Date
Authorization Information
Name of Insured
Insured's Relationship to Patient
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Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Message Section
Data Element
Guarantor (GT1)
Insured's Date of Birth
Insured's Address
Report of Eligibility Flag
Report of Eligibility Date
Verification Date/Time
Verification By
Type of Agreement Code
Policy Number
Policy Deductible
Policy Limit - Amount
Insured's Employment Status
Insured's Administrative Sex
Verification Status
Insured's ID Number
Signature Code
Signature Code Date
Set ID - GT1
Guarantor Number
Guarantor Name
Guarantor Address
Guarantor Ph Num - Home
Guarantor Ph Num - Business
Guarantor Type
Guarantor Relationship
Guarantor Employer Name
Guarantor Organization Name
Participation Instance ID
Action Code
Participation
Participation Person
Participation Address
Participant Telecommunication Address
Set ID - NTE
Participation (PRT)
Notes and Comments
(NTE)
Diagnosis (DG1)
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Additional Notes
Comment
Set ID - DG1
Diagnosis Code - DG1
Diagnosis Description
Diagnosis Date/Time
Diagnosis Type
Outlier Type
Diagnosis Priority
Confidential Indicator
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Table 18: Dataset Requirements
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Appendices
Appendix A: LOI Glossary
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Request for Cancellation (RFC): Request by the Provider (Order Placer) not to perform the
order.
Cancellation: Act of cancelling the order.
Laboratory: A facility or organization that performs laboratory testing on specimens derived
from humans for the purpose of providing information for the diagnosis, prevention, treatment
of disease, or impairment or assessment of health.
Laboratory Information System (LIS): An information system that receives, processes, and
stores information related to laboratory processes. LIS may interface with HIS and EHR
applications.
To meet the requirements of the LOI Use Case the LIS, at minimum, must have the following
characteristics:
o Data model that includes discrete representations of patients, clinician end-users,
laboratory test requisitions, laboratory tests (including panels), and laboratory test
results (at the level of individual analytes);
o Capability to receive electronic messages that communicate a laboratory order from a
physician;
o Capability to send electronic messages that report the status and results of laboratory
tests that have been ordered;
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This definition is very minimal and omits many features and capabilities that are typically
associated with laboratory information systems. This minimal characterization is intentional, as
to include the broadest possible set of LIS systems in the use case. The minimal nature of the
definition by no means excludes LIS with significantly greater capabilities.
Laboratory Order System: Software, either stand-alone or as part of an EHR system, used by a
Provider (Order Placer) to manage a laboratory order, including generating the laboratory
requisition, sending it to a laboratory, and monitoring/tracking of the status of the laboratory
order.
Typically a laboratory order system is an integral part of an order management system that
enables users to manage orders for many different types of services, procedures, supplies, etc.
Since we only focus on data exchange relative to laboratory orders we are purposely using a
very limited definition.
Laboratory Requisition: A set of information that constitutes an official request for one or more
laboratory tests to be performed on an individual patient. A laboratory requisition is specified in
a clinical setting and communicated to a laboratory as a discrete paper or electronic artifact.
Laboratory requisitions always include at least one test order.
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
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Laboratory Order: A request to perform an individual test or panel.
Test: A medical procedure or named set of related procedures that involves analyzing one
analyte using a single sample of blood, urine, or other specimen from a patient for the purpose
of diagnosing a disease or medical condition, planning or evaluating treatment, or monitoring
the course of a disease.
Panel: While there are differences in the meanings of the terms “panel” among various
laboratories, for the purposes of this guide, it is defined as a grouping of procedures that
measure multiple analytes from a single specimen and can be requested through one laboratory
order. This is also referred to as battery. For example, a CBC or a urinalysis may be referred to
as a panel.
Profile: A set of laboratory orders that involve multiple tests and panels and that may require
multiple specimens, but can be requested as a single unit for convenience. For example, a
“diabetic profile” might include a CBC, a glycosylated hemoglobin test, and a urinalysis. This
term is frequently used interchangeably with “order set”, thus a profile that contains a variety of
laboratory test orders may be on its own or be combined with other test orders (e.g., radiology
image, consult, etc.) be considered an order set. Profiles shall not be communicated to the
laboratory.
Analyte: Component represented in the name of a measurable quantity.
Laboratory Message: An electronic communication between a Laboratory Order System and a
Laboratory Information System related to laboratory testing. Laboratory messages may be
used to request that one or more tests be performed, to change previous requests for testing,
to report the cancellation of requested tests, or to report the results of requested tests.
Example: This example is included to show the use of the above terms in the context of
electronically placing a laboratory order.
On Monday, Dr. Smith’s Laboratory Order system sent a message to Acme Laboratories that
contained a laboratory requisition for Mrs. Parker. In addition to Mrs. Parker’s demographic
and insurance information, the requisition included two test orders -- one order for a lipid panel
test and one order for a urine protein test. The order for the lipid panel test included the
additional information that Mrs. Parker was fasting when the specimen was collected. On
Tuesday, Dr. Smith’s Laboratory Order system sent another message to Acme Laboratories
requesting that a test order for an electrolyte panel test to be added to the laboratory
requisition sent the previous day. On Wednesday, the laboratory sent a message to Dr. Smith’s
EHR system indicating that the urine sample was insufficient to perform the urine protein test,
so the laboratory could not fulfill that test order and had cancelled that test. On Thursday, the
laboratory sent a message to Dr. Smith’s EHR system containing the results of the lipid panel
test and the electrolyte panel test.
Appendix B: Additional Laboratory Cancellation Reasons
1. Specimen related:
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
a. Specimen vial broken during transit
b. Quantity not sufficient
c. Specimen clotted
d. Container was received empty
e. Specimen hemolyzed
f. No specimen received
g. Specimen contains fibrin clots
h. Frozen specimen received, assay requires ambient specimen
i. Specimen icteric, unsuitable for analysis
j. Improper specimen submitted for testing
k. Specimen leaked during transit
l. Specimen thawed during transit. Unsuitable for analysis.
m. Specimen grossly lipemic, unsuitable for analysis
n. Specimen mislabeled
o. Specimen received unlabeled
p. The name of the patient was not indicated on the specimens received
q. Electronic order, no specimen received after 72 hours
r. Specimen received beyond stability
s. Specimen received at wrong temperature
t. Cellular distortion
2. Cancelled per client instruction
3. Lab work flow:
a. Duplicate order
b. Unable to calculate results
c. Instrumentation error
d. Incorrect test ordered by client
e. Laboratory accident
f. A valid result could not be obtained
g. A reportable result was not obtained for this test because assay duplicates were
unacceptable and insufficient sample remained to repeat the assay.
h. Assay quality control was out of the acceptable range. Insufficient sample remains to
perform repeat analysis.
i. Reagent unavailable
j. Test ordered that is not available on laboratory’s test menu
4. Quantity insufficient to complete all testing ordered. Sample is being held pending receipt of
priority information.
Appendix C: Related Use Cases

LRI Use Case
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Department of Health and Human Services (HHS) Office of the National Coordinator (ONC)
Use Case Development and Functional Requirements for Interoperability
Ambulatory Laboratory Orders
Appendix D: Previous Work Efforts
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HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US
Realm (July 2012)(LRI IG)
CHCF ELINCS Orders
Appendix E: References
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HL7 2.5.1 Standard, Chapter 4 Order Entry
CHCF ELINCS Orders v1.0
HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US
Realm (July 2012)(LRI IG)
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