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Laboratory Order Conceptual Specification

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Laboratory Request

Executive Summary

  • This document contains the necessary definitions, descriptions, graphics, and artifacts relevant to the implementation of an electronic request for healthcare services between an ordering provider and a performing laboratory. In this document, laboratory refers to the collection and processing of specimens.

Business Model Conceptual Artifacts

Business Context

  • The laboratory domain comprises the models, messages, and other artifacts that are needed to support messaging related to laboratory tests, or observations.
  • The HL7 Laboratory domain includes the provision and use of analytic services in areas such as chemistry, hematology, serology, histology, cytology, anatomic pathology, microbiology, and virology. It does not include blood bank or blood transfusion services. (Note that not all lab specializations will be supported in this first HL7 V3 R1 of the Laboratory Request Topic.)
  • Analytic services typically result in observations returned to the order placer and/or added to the patient medical history. Observations may be simple numeric quantitative measurements, such as a blood serum glucose level, qualitative measurements such as micro-organism susceptibility to a particular antibiotic, or complex diagnostic pathology reports.
  • Services may be delivered/executed at a external lab, an on-site lab, or at the point of care. This topic covers service requests from all locations, including bedside and in-hospital, clinic and outpatient, and lab-to-lab interactions. It includes orders accompanied by specimens to be analyzed, as well as orders for which the performing laboratory is responsible for obtaining the specimens. Observations (results) may be generated for both ordered and unordered (e.g., POC) tests.
  • Workflow includes ability of service provider to accept, modify, or reject an order, with appropriate intent indication to the orderer. Modification may include breaking a parent order into child orders or work items Modification include substituting a particular test Available/orderable Laboratory services may be described by an act in definition mood.

Business Function

For this specification, the business function at its most basic is about ordering (requesting a healthcare service) and the fulfillment of that request by filling entities.

Basic business process use case bubble diagram

The following bubble diagram describes the ordering business process.

ManageOrdersUseCaseBubble.png

Conceptual Roles

LaboratoryRequestActors.png

Storyboards and Activity Diagrams

Universal Storyboard - Create Lab Order (Lab Collect)

Eve Everywoman, a 27-year-old female, presents at Good Health Hospital Outpatient Clinic
and is seen by Dr. Patricia Primary. Eve reports a history of Anemia and recent,
excessive tiredness.  Dr. Primary enters a request to check the iron levels in Eve’s
blood into her care system.  Dr. Primary’s care system then sends the test requests to 
the lab system at the Good Health Hospital’s Laboratory service.  Eve receives a paper 
order requisition that serves as a reminder,  provides instructions for where to find 
the collection center, and also details preparation instructions for the patient to 
follow (no food or drink from midnight until collection time on the day of collection).

Later that week Eve presents herself at the Lab Collection Center.  The lab looks up and 
finds the order for her testing in the lab system.  The appropriate blood samples are 
extracted, their containers labeled, and the sample information added to the information
in the lab system. 

The lab performs the analysis on the specimen(s), adds the results to the lab system, and
sends the results to Dr. Primary’s care system reported as final.  Dr. Primary reviews the
results, formulates a treatment, if needed, and notifies Eve Everywoman of the results and
treatment.

Universal Storyboard - Create Lab Order (Provider Collect)

Adam Everyman, a 53-year-old male, has an appointment with Dr. Carl Cardiology at Good Health 
Hospital Outpatient Clinic.  Adam reports a history of Anemia and recent, excessive tiredness.  
Dr. Cardiology enters a request to check the iron levels in Adam’s blood into his care system.  
Dr. Cardiology’s care system then sends the test requests to  the lab system at the Good Health 
Hospital’s Laboratory service.  Dr. Cardiology’s staff collects the necessary specimen(s), 
labels them, packages them and ships them to the laboratory. 

The lab receives the specimen(s) and accessions each.  Specimen is evaluated for use by the 
Laboratory Technician.  Next, an analysis is performed on the specimen(s), the results are added 
to the lab system and QA'ed as appropriate.  Upon completion of QA, the results are structured as 
a report document using CDA.  The report is then sent to Dr. Cardiology’s care 
system reported as final.  Dr. Cardiology reviews the results, formulates a treatment, if needed, 
and notifies Adam Everyman of the results and any follow-up treatment.

Universal Storyboard - Create Lab Order (3rd Party Collect)

In some countries there are services separate from the provider or lab who travel to each patient in order to perform specimen collection.

Eve Everywoman, a 27-year-old female, presents at Good Health Hospital Outpatient Clinic
and is seen by Dr. Patricia Primary. Eve reports a history of Anemia and recent,
excessive tiredness.  Dr. Primary enters a request to check the iron levels in Eve’s
blood into her care system.  Dr. Primary’s care system then sends the test requests to 
the lab system at the Good Health Hospital’s Laboratory service.  Eve receives a paper 
order requisition that serves as a reminder,  provides instructions for where to find 
the collection center, and also details preparation instructions for the patient to 
follow (no food or drink from midnight until collection time on the day of collection).

Later that week Eve calls a 3rd Party collection service.  The service looks up and 
finds the order for her testing in the regional repository.  The 3rd party collector 
then travels to the patient location.  The appropriate blood samples are 
extracted, their containers labeled, and the sample information added to the information
in the repository. 

The lab receives the specimen(s) and accessions each.  Specimen is evaluated for use by the 
Laboratory Technician.  Next, an analysis is performed on the specimen(s), the results are added 
to the lab system and QA'ed as appropriate.  The lab performs the analysis on the specimen(s), 
adds the results to the lab system, and sends the results to Dr. Primary’s care system 
reported as final.  Dr. Primary reviews the results, formulates a treatment, if needed, and 
notifies Eve Everywoman of the results and follow-up treatment.

Universal Storyboard - Revise Lab Order (Provider Collect)

Adam Everyman, a 53-year-old male, has an appointment with Dr. Carl Cardiology at Good Health 
Hospital Outpatient Clinic.  Adam reports a history of Anemia and recent, excessive tiredness.  
Dr. Cardiology enters a request to check the iron levels in Adam’s blood into his care system.  
Dr. Cardiology’s care system then sends the test requests to  the lab system at the Good Health 
Hospital’s Laboratory service.  Dr. Cardiology’s staff collects the necessary specimen(s), 
labels them, packages them and ships them to the laboratory.

The next day during a review of Adam's chart, Dr. Cardiology determines that he needs to order 
an additional test.  Dr. Cardiology's staff updates their local system to modify the order which
is then communicated to the lab system.  Since the specimen was already sent to the lab, the 
staff then contacts the lab to ensure they are aware of the requested modification.

The lab receives the specimen(s) and accessions each.  Specimen is evaluated for use by the 
Laboratory Technician and whether there is enough specimen volume to accomodate the additional 
tests.  There is sufficient specimen, therefore, analysis is performed on the specimen(s), the 
results are added to the lab system and QA'ed as appropriate.  Upon completion of QA, the results 
are structured as a report document using CDA.  The report is then sent to Dr. Cardiology’s care 
system reported as final.  Dr. Cardiology reviews the results, formulates a treatment, if needed, 
and notifies Adam Everyman of the results and any follow-up treatment.

Business Process

At its most basic, the business process documented in this use case is one of a requested service and documentation when that service is performed. Many ambulatory use cases follow this basic pattern and the only communications are the two, the first from placer to filler with the request and the second from the filler to the placer with the fulfillment of that request. Conversely in acute care settings, the business process for laboratory specimen testing is quite rich as the order placer and laboratory perform more electronic exchanges, usually centered around specimen collection.

Lab Specific Business Process

For Laboratory Diagnostics (specimen testing), the following illustrates high-level business functions:

  1. Diagnostic (or Public Health) Specimen-based Laboratory work requested for a subject (patient, animal, environmental location, etc)
  2. Specimen collected from subject
  3. Specimen accessioned by lab (i.e., enters lab testing process)
  4. Specimen processed into testable samples
  5. Samples tested by lab
  6. Results from lab testing obtained, interpreted, approved/authorized, formatted
  7. Results returned to requester
  8. Requester determines if all requests have been fulfilled, next steps and course of action

LaboratoryOrderProcessConceptualStateMachine.png

Business Process Assumptions

While the above list shows the performed steps in a basic lab ordering/fulfillment process, each of these steps may be performed by different actors/roles in any one specific process; for example, a Clinician, Laboratory Technician (e.g., phlebotomist), Investigation Team Member, the Subject (patient), or a person responsible for a Subject may collect the specimen. In addition, the steps may be performed at different locations; specimens may be collected at the point of care, at the subject's location (e.g., at a patient's home, "in the field", etc), in the testing lab, or at a specimen collection organization. The steps may also be performed in different order or not performed at all under given, specific conditions - a specimen may not require any processing prior to being tested or a specimen is assigned an accession number prior to being collected if it is being collected in the lab. Finally, the involvement of an electronic system to capture the information and facilitate the business process is not assumed in the above steps and may not be present depending upon the conditions under which each step is performed.

Event Flows

Below is the event flow for Create Laboratory Order which defines the necessary activities, decisions, and information exchange points. The Laboratory Order Repository needed for the 3rd storyboard above is handled via an alternate flow and is not represeted in the diagram below.

CreateLaboratoryOrderEventFlow.png

Next is the event flow for Revise Laboratory Order. Note that any revision is a 'request to modify'. Depending on the situation, the performing laboratory may reject the revision.

ReviseLaboratoryOrderEventFlow.png

Information Model Conceptual Artifacts

Conceptual Information Model

 Comment:
   Provide links to the Analysis Information Model for the domain

The following classes were derived from the storyboards and use cases.

Conceptual Laboratory Information Objects.png

Conceptual Data Types Model

ConceptualDatatypes.png

Conceptual State Model

There are a couple of different types of state models. The first is representing the status of the whole business process. The states are represented as statuses which correlate to Key activities on the event flow. The second are a set of state models, one for each Key information object, defining the appropriate statuses for each object.

For the business process state machine:

LaboratoryOrderProcessConceptualStateMachine.png

We can derive the following request object states and transitions from the above storyboards:

LaboratoryOrderSTM.png

As you can see, the request object has a status for when the fulfiller asserts the request is fulfilled, but the request has not yet evaluated that assertion (called fulfillment resolution). There are also the two other, expected, request statuses: active and complete. In the simplest request use cases, the request only takes one of these states. We can derive the following fulfillment object states and transitions from the storyboard:

FulfillmentLiteSTM.PNG

Again the status, this time for fulfillment, is restricted in this simplest use case to null and resulted.

Lastly for this simple use case, we can derive the following result object states and transitions from the storyboard:

ResulttLiteSTM.PNG

In this use case, only the completed state is important for interoperability.

Concept Domains

  • ActStatus
  • LaboratoryOrderableTestCode
  • LaboratoryQualitativeResultCode
  • DocumentTypeCode

Solution Specification

Scenario #1 - Create Lab Order

Overview

Business Scenario

The event flow for a simple lab order is shown below

File:Create Laboratory Order Activity Diagram.png

Contract Roles and Agents

The commissioning and responsible parties involved in this process include:

Specification Reference Commissioning System Role Responsible System Role Operation
Order Requestor (Placer in v2) Order Request Manager createRequest
Order Request Manager Fulfillment Manager createRequest
add add add

Computational Viewpoint

The following sequence diagram depicts the interactions that support the above event flow

SimpleLabOrderSequence.png

Service Dependencies

 Comment:
   Describe any dependencies of the process being specified

The parties supporting this process are the Order Request Manager and Fulfillment Manager, depicted below

OrderManagementConceptual.png FulfillmentManagementConceptual.png

Implemented Patterns

 Comment:
   Indicate the any patterns that apply to this process specification

Contractual Semantics and Issues

Conformance Statements

Comment:
   define the conformance criteria for this specification

Computational Services

Order Request Manager

Fulfillment Manager