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: 0.2
Domain: Clinical Laboratory

Status: This document is a detailed profile proposal that is being developed from a brief proposal initially presented to the IHE Laboratory Domain in August 2011. The completion target date for the detailed proposal is early September 2011.

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 prior to testing

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.
3. A physician seeing a patient for hyperlipidemia writes a future order for a lipid panel in 4 months and asks the patient to return in 6 months for follow up. When the patient has not visited the lab by 5 months, the order expires and an LCC message is returned to the physician's EMR indicating no-show expiration and allowing extension of the order with notification to the patient, or cancellation of the order. Note: It often matters clinically whether a test has expired due to a no-show or has been canceled for other reasons. Current systems do not do a good job of providing this information to clinicians and queuing up their likely responses.

Order fulfillment (post-result action to fully meet 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. Note: This scenario is derived from actual events and is representative of multiple examples of feedback to test kit vendors from practical use settings. Such test performance monitoring is currently done manually with significant effort, cost, and delay in reporting.
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.
3. An endocrine service that performed IGF-1 testing for pituitary evaluation found occasional instances where mildly-to-moderately elevated levels of IGF-1 occurred in patients who did not have pituitary disease. This discrepancy between lab and clinical findings was reported on an ongoing basis when it occurred, with a brief LCC message that could be sent from the EHR to the LIS with only a couple of clicks to note the lack of clinical correlation. No technical problems with the test were found locally, but ongoing statistical analysis of these responses across multiple tests revealed a higher-than-expected rate for IGF-1 and this was reported to the test vendor. Similar performance monitoring reports from multiple locations led the vendor to review the use of a reference range established in Scandinavian populations with US patients, and design a reference range study for the US. Note: This scenario is derived from actual events. A standard method to simply and easily capture clinical assessment of test performance would allow automated performance monitoring and much faster reporting and response to performance issues than is currently possible. Ultimately, this capability would promote performance improvement at both the local laboratory and national vendor levels.

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

The LCC Profile will work in tandem with the Laboratory Testing Workflow (LTW) Profile in support of the use cases described above. Currently the LTW defines five transactions (LAB-1 to LAB-5) that flow between four actors to support laboratory test ordering and resulting. The only available response to orders that cannot be completed is to refuse or cancel them. There is no available response to results that do not completely fill the clinical need. The LCC defines two additional transaction types with new triggers that increase the flexibility of the order-result interaction. The first carries a proposal for modification of orders, and returned modified orders are associated with the original request. The second carries a request for verification or interpretation of a result, or an assertion that a test or result may be erroneous.

New actors

For simplicity, initial plans call for the LCC to use existing actors from the LTW (see below). New actors will be considered only if absolutely necessary.

Existing actors

The LTW Profile defines four actors, the Order Placer, the Order Filler, the Automation Manager, and the Order Results Tracker. LCC transactions will flow between the Order Placer, Order Filler, and Order Results Tracker. Note that this approach will require the local LIS to shift roles between Order Filler and Order Placer during parts of the use cases that deal with reference laboratories. The essential simplicity of the Placer/Filler/Tracker relationship is preserved and additional participants in testing are accommodated by allowing the focus of the Placer/Filler relationship to shift rather than by defining new actors.

New transactions (standards used)

The LCC will define at least two new transactions, LAB-6 and LAB-7. LAB-6 will be triggered in the Order Filler after ordering but prior to testing, when an order cannot or should not be carried out based on information available to the laboratory. It will carry information to the Order Placer on why the order cannot be completed, and a request for a replacement order. Optimally, it will recommend replacement orders so that the Order Placer can queue up those orders for easy submission. The response to LAB-6 might be carried in the current LAB-1 Placer Order Management transaction defined by the LTW. If some additional information is required for linking replacement orders with the original order, limited modification of the LAB-1 transaction may be necessary.

LAB-7 will be triggered in the Order Results Tracker when test results are clinically or operationally problematic. It will carry information to the Order Filler on the identity and results of the original order and test, and a request for additional (post-result) action. The response from the Order Filler (e.g., an amendment, addendum, or interpretation) can probably be returned to the Order Results Tracker in the current LAB-3 Order Results Management transaction without modification.

The LCC will be based on HL7 messaging (v. 2.51) similar to the LTW. Standard terminologies for new data elements such as reasons for order modification and post-result action requests will be identified during the project, if possible, or basic term lists may be created. If changes in the field content of HL7 message segments are needed, they will be pursued in collaboration with the HL7 Orders and Observations workgroup.

Impact on existing integration profiles

The LCC may require modification of the LAB-1 transaction of the LTW as noted above. The LAB-3 transaction probably will not need to be modified. No other profiles will be affected.

New integration profiles needed

The LCC will be a new integration profile.

Breakdown of tasks that need to be accomplished

1. Use case completion [2 months]
2. Extraction of data elements, actors, and transaction patterns from use cases [2 months]
3. Message construction (new and any required modifications, interaction with HL7 O&O) [5 months]
4. Final documentation [1 month, Summer 2012]
5. Initial balloting [Fall 2012]
6. Initial Connectathon implementation [N.A. Connectathon, Winter 2013]

Risks

1. Failure to attract and maintain adequate interest and personnel
2. Inadequate support for necessary data types and data models in existing standards, requiring standards development work (additional resources & delay)
3. May lose attention if not part of Meaningful Use (time frame may be OK for phase III, though)
4. Balloting issues that introduce delay, particularly if the 2013 Connectathon opportunity is threatened
5. Implementation failure -- not a problem for development of the spec, per se, but the effort is wasted if there is no broad implementation. A Connectathon demonstration is key, as is commitment to marketing through CAP and others.

Mitigating factors:

1. Multiple committed vendors already, including industry leaders
2. Strong backing and logistics support from the College of American Pathologists
3. Group members are participants in the S&I Framework effort
4. Group members are also members of the HL7 O&O Workgroup, will draw on that expertise, and will share plans and progress between the groups

Open Issues

1. Final participant roster
2. Are all necessary data elements adequately covered in existing standards (i.e., HL7 v. 2.51) and, if not, how much additional standards work might be required?

Effort Estimates

Optimal personnel include 2 - 4 pathologists (MD) and 4 - 8 industry participants. The ideal final group is 8 - 10 committed participants. Development of the specification will take about one year, with subsequent balloting and a Connectathon demonstration.