LCC Long Proposal - wiki

Proposed Work Item: Laboratory-Clinical Communications (LCC)

Proposal Editor: Jim Harrison, College of American Pathologists and University of Virginia
Work Item Editor: Jim Harrison
Date: in development
Version: 0.1
Domain: Clinical Laboratory

Summary

The communication and resolution of order modification, result verification, and result interpretation problems is an integral part of quality laboratory service but it is currently managed outside of information systems. Communications can be delayed or lost and correction of the immediate and systemic problems indicated by these communications is time consuming and error prone. This new profile will enable rapid, standardized, automated capture of and response to sample problems or result questions, and will allow this information to be logged, tracked, and included in QA studies and process improvement projects.

The Problem

The current order-result paradigm supported under HL7 v. 2 does not capture all the clinically-important interactions related to ordering and resulting laboratory tests. Two key aspects of this limitation are: 1) there is no standard way to convey information between the laboratory and clinicians when modification of orders is required prior to testing, and 2) there is no standard way for the laboratory and clinicians to communicate about a test result that may require verification, clarification, interpretation, or additional work to fulfill the original clinical need.

These communications are typically carried out by phone, which is inefficient for the laboratory and clinicians, is not amenable to automation and decision support, prevents the laboratory from communicating through the EHR as a full member of the patient’s care team, and does not create documentation useful in quality assurance and process improvement. The LCC Profile will define workflows, data elements, and messages to support automated communications between the LIS and EHR about orders and results.

Use Cases

Order modification:

1. A problem in transport damages some of a set of blood specimens. The tubes allow some but not all of the ordered tests to be completed, but the selection of the most useful combination depends on the patient's clinical status. An LCC message is returned to the ordering EHR that provides notice of the loss of specimen and presents alternatives for testing on the available specimens. The clinician chooses the most useful combination of tests to run immediately and schedules a follow up blood draw to provide specimens for the remaining tests. The information is returned to the LIS where the initial order is amended, the follow up blood draw is scheduled as a new procedure, and the problem and its resolution are captured into a QA database.
2. Specimens are drawn by a local clinical laboratory and shipped to a reference laboratory, with a testing order transmitted via their reference laboratory interface. On arrival it is found that the specimen is of inadequate volume. An LCC message is returned to the local laboratory via the interface that indicates the problem, the tests that can be carried out on the available specimen, and the amount and type of additional specimen needed. If appropriate specimens are available, the local lab can elect to ship them immediately to complete the original order. Otherwise, the laboratory can pass the message back to the ordering EHR for amendment of the original order and/or additional sampling.

Order fulfillment (meeting the clinical need):

1. A patient in the ER with substernal chest pain and a non-diagnostic EKG initially has a cardiac Troponin I (cTnI) below the level of detection but the second value is elevated, prompting the patient’s admission to the acute cardiology service. The third cTnI value is again undetectable. Verification of the previous elevated value and the current normal value are requested through the EHR via an LCC message, yielding a corrected result of “undetectable” for the previously elevated specimen. The patient is discharged without catheterization. Routine monitoring of verification requests reveal an elevated number for cTnI since a new test formulation was deployed several months previously. Reports of these results to the test vendor from multiple sites lead to reformulation of the assay with improved performance.
2. A patient with joint pain, fever, and sudden onset deep venous thrombosis showed an elevated PT and PTT with otherwise normal coagulation tests. An interpretation was requested of the PT and PTT results from the EHR via an LCC message. The interpretation added as an addendum to the test panel indicated that the results were consistent with a lupus anticoagulant and recommended the appropriate evaluation strategy.

Standards & Systems

This proposed profile represents a backporting of parts of the HL7 v. 3 laboratory ordering behavioral model to HL7 v. 2 so that they may be available to the laboratory community prior to broad implementation of HL7 v. 3. The v. 3 behavioral modeling is ongoing and the LCC profile will track that work over the next year as it continues. The focus of communication for LCC will be between LIS and EHR, and the project will attempt to attract LIS and EHR vendors to the Laboratory Domain to contribute to the work. We anticipate that the workflow and use cases from this project will be beneficial to both separate and integrated LIS/EHR systems through the definition of a more comprehensive order-result workflow that addresses clinical needs.

Technical Approach

In development.

New actors

In development.

Risks

In development.

Open Issues

In development.

Effort Estimates

In development.