Performance Monitoring Workflow

The Performance Monitoring Workflow (PMW) profile provides guidance for communication of laboratory performance monitoring data such as proficiency testing orders and results with external performance evaluation organizations.

Summary

Most of the assay results produced by clinical laboratories are for the purpose of patient care. However, there are results that are produced for assessment of laboratory performance rather than clinical care, for example test validation or performance monitoring in comparison with other laboratories. These results may be derived from analysis of repurposed patient samples, or they may use locally-concocted or purchased samples. Existing IHE Pathology and Laboratory Medicine profiles are designed to communicate patient results for clinical care. Results produced for performance assessment are often handled manually outside of the clinical workflow. This difference in workflow is resource-intensive and error prone, and it decreases the utility of performance monitoring in assessing all elements of the clinical workflow.

The PMW Profile defines workflow and content for messages that communicate orders and results for tests that are carried out to evaluate the technical performance of laboratories. The initial use case is proficiency testing (testing and reporting results on external specimens, with results compared for consistency between laboratories). The PMW profile automates ordering and result reporting of performance monitoring testing in a manner resembling clinical testing and reporting so that the workflow and analyses are streamlined and less error-prone than manual methods, and more closely reflect clinical specimen testing. The scope of the PMW includes communication of orders for testing of performance monitoring specimens and return of results for those specimens. Other activities related to performance monitoring, such as registration into performance monitoring programs and selection of a menu of tests for monitoring, are out of scope for the profile and are supported by the business systems of performance monitoring providers.

Performance monitoring overview. Laboratories subscribe to a performance monitoring program and receive specimens for testing (top, gray). After testing the results are analyzed and a performance report is provided (bottom, gray). The PMW profile defines messages used to order testing and report individual test results (middle, black, in dotted box).

Benefits

Many laboratories carry out performance monitoring using manual methods or non-standard online portals. These activities include local entry of orders for performance monitoring tests and reporting of the test results for aggregation, analysis, and comparison with other laboratories. This manual workflow is time-consuming, error-prone, and does not match the workflow for handling patient specimens. The PMW profile defines standard orders and results messages for performance monitoring specimens, which can be used in a laboratory workflow similar to outreach patient specimens. This saves time and reduces irrelevant error, and it creates the possibility of extending proficiency testing to include a meaningful evaluation of data returned by the laboratory to the proficiency testing provider, including the accuracy of test and result coding, and the accuracy of transfer of data elements from orders to results messages.

Details

The PMW profile supports test orders and results that have the primary purpose of monitoring the quality of laboratory operations rather than clinical care, using a standard reference laboratory interface as defined by the Interlaboratory Workflow (ILW) profile. The specimens used for performance monitoring may be repurposed patient material, but they also may be artificially produced and include human components, animal components, and/or chemical reagents. Performance monitoring specimens may be purchased from a vendor that offers a performance monitoring program including analysis of results and reports that include comparison to accepted performance metrics or other laboratories. For some rare tests and laboratory-developed tests, groups of laboratories may share specimens and analyze comparative results themselves.

The scope of the PMW profile includes only order communication and individual specimen result reporting for performance monitoring specimens. Other communications between the provider of a performance monitoring program and a participating laboratory, such as registration into a performance monitoring program, mapping a laboratory’s local test codes to the provider’s catalog of supported tests, and providing aggregated performance results are outside the scope of the profile and would normally be handled by the program provider’s business process systems such as an online portal or paper forms.

The PMW profile extends existing PaLM TF profile messages for performance monitoring. Communications between the performance monitoring program provider and participating laboratories use a reference laboratory interface and Interlaboratory Workflow (ILW) profile messages with the provider acting as a “local” laboratory (issuing orders and receiving results) and the participating laboratories acting as “subcontracting” laboratories (receiving orders and returning results). The internal communication of orders and results in participating laboratories use messages from the Laboratory Testing Workflow (LTW) and Laboratory Analytical Workflow (LAW) profiles.

Systems Affected

• Performance monitoring provider business systems may issue orders to subscribing laboratories for testing of performance monitoring specimens.
• Subscribing laboratory LIS may receive orders for testing, manage testing, and return results for individual performance monitoring specimens to the provider.

Actors & Transactions:

Performance monitoring process flow. The PMW profile defines transactions between the external proficiency testing provider and the subscribing laboratory LIS. These transactions resemble those defined by the ILW profile (left side above). Once in the local environment, data flow follows pathways defined for patient testing by the LTW and LAW profiles (middle and right). See below for links to these existing profiles.

Specification

Profile Status: In Development

Documents:

IHE Pathology and Laboratory Medicine Technical Framework:

• Vol. 1 - Sections 3 (LTW Profile) and 5 (LAW Profile)
• Vol. 2a
• Vol. 2b
• Interlaboratory Workflow (ILW) Technical Framework Supplement

Underlying Standards:

• HL7

See Also

Related Profiles

• Inter Laboratory Workflow [ILW] defines messages to communicate between laboratories and external entities.
• Laboratory Testing Workflow [LTW] defines standard order and result communication between laboratory systems.
• Laboratory Analytical Workflow [LAW] defines communication by instrument managers for controlling laboratory analyzers.

Consumer Information

A FAQ about the profile will be linked here in the future.

Implementer Information

Additional information supporting implementation will be linked here in the future.

Reference Articles

1. Brookman B, Bélavári C, Butler O, et al. Proficiency testing in analytical chemistry, microbiology and laboratory medicine: discussions on current practice and future directions. Accred Qual Assur. Published online April 12, 2024. doi:10.1007/s00769-024-01588-9

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