Laboratory Point Of Care Testing

Laboratory Point Of Care Testing LPOCT) covers in vitro diagnostic tests performed on the point of care in a healthcare institution.

Summary

The Laboratory Point Of Care Testing Profile covers the workflow related to in vitro diagnostic tests performed on the point of care or on patient bedside by caregivers in the clinical wards of the healthcare institution, this process being supervised by a laboratory of the institution. This supervision includes clinical validation of POC results, Quality Control (QC) surveillance, point of care devices surveillance, reagent delivery, and education on good testing practices delivered to the ward staff. The point of care testing devices operated by physicians and nurses are connected to and controlled by a central Point Of Care Data Manager. This POC Data Manager is connected to the LIS of the laboratory for consolidation of the point of care testing results, and to the HIS of the institution, which provides up to date patient data.
The main characteristics of point of care testing are:

• Specimen drawn from the patient by the caregiver, tested immediately, and then eliminated. (no pre or post-processing of the specimen).
• The results are produced and displayed at once on the point of care device, and can be used immediately in the caregiver's clinical decisions.

The main value proposition of this profile is the securization of the workflow by a real-time patient identity checking and the consolidation of point of care orders and their observations in the enterprise-wide repository of orders and observations.

Benefits

Reduces Errors and Enhance Patient Care

• For POC devices persistently connected, the real time patient identity checking secures the process:

• The caregiver scans or enters manually a patient ID or encounter ID on the device, together with contextual information (device id, staff id, tests to be performed...)
• The device queries the POC data manager and obtains in the response the patient identity as it is registered in the HIS, and displays the patient name.

• POC testing devices usually require a minimal quantity of blood to operate. No transportation, no delay, hence no pre-processing of the specimen. Thus POC testing minimizes blood drawing from the patient, which makes this process particularly accurate in pediatric and neo-natology wards.
• Accelerates the diagnostic, thus the treatment, in all situations where simple chemistry or hematology tests is critical to set the proper diagnostic or choose the best immediate action. Point of care testing is for this reason usefull in emergency departments, intensive care units, and operating theaters.
• Consolidates point of care testing observation in the common repository of orders and observations, thus keeping available for further historic access by caregivers, point of care observations together with laboratories test results.

Favors independence of healthcare institution from their clinical and ancillary systems and devices

• By providing clear specifications of interfaces between point of care devices, data manager and LIS, this Integration Profile enables the healthcare insitution to replace one of these systems without breaking the existing data workflows.

Details

The Laboratory Point Of Care Testing (LPOCT) Integration Profile establishes the integrity of in vitro diagnostic tests performed on the point of care by ward staff for a patient, inside the healthcare institution.
This Integration Profile is bound to in vitro diagnostic testing (tests performed on in vitro specimen). It supports all laboratory specialties that can be performed by nurses on handy testing devices usable on the point of care. Among other examples are blood gas, electrolyte, hematocrit, glucose level...
The LPOCT Integration Profile covers five major use cases:

• Point of care observations to be matched with an existing order previously entered in the enterprise order management system. Process secured by real-time patient identity checking.
• Unordered observations. The order is to be generated afterwards by the enterprise order management system upon request from the LIS of the supervising laboratory. Process secured by real-time patient identity checking.
• Unordered observations on a POC device with an intermittent link (no patient identity check)
• Manual entry of unordered observations. In that use case, the test is manual and the device is a keyboard the observations are keyed in on.
• Centralization of Quality Control (QC) results from the point of care devices to the point of care data manager.

LPOCT Integration Profile defines 3 Transactions:

• LAB-30 "Initiate point of care testing" accomplishes the real-time patient identity check before the test starts. This transaction is mandated by the "Patient identity checking" option.
• LAB-31 "Produced observation set" uploads to the POC data manager a set of results measured on a patient specimen or on a QC specimen by a POC device. The POC data manager controls the coherence of this set of observations against its own business rules, and accepts it or rejects it.
• LAB-32 "Accepted observation set" uploads the accepted patient results from the POC data manager to the LIS of the supervising laboratory.

These three transactions are leveraging the standard POCT1A published by CLSI.

Systems Affected

Systems involved in this profile are:

• A set of point of care testing devices, performing the tests and producing the obervations. Each one implements the Actor "Point Of Care Result Generator" (POCRG).
• One or more Point Of Care Data Managers (Actor POCDM). Each one consolidates the observations produced by a set of POCRGs.
• A Laboratory Information System (LIS) operated in the laboratory in charge with the overall supervision of the point of care testing process. This LIS implements the Actor Order Filler.

Actors & Transactions:

Other requirements for systems implementing LPOCT (dependencies towards IT Infrastructure and Laboratory Profiles):

• An application implementing one of the Actors Order Placer, Order Result Tracker, Order Filler shall also implement the Actors Patient Demographics Consumer and Patient Encounter Consumer from either PAM or PDQ Profile or both.
• An application implementing one of the Actors Order Placer, Order Result Tracker, Order Filler shall also implement the Actor Secure Node from the ATNA Profile, as well as the Actor Time Client from the CT Profile.

Specification

Profile Status: Trial Implementation

Documents:

• IHE Laboratory Technical Framework:

Underlying Standards:

• HL7
• POCT1A published by CLSI

See Also

Related Profiles

• Integration Profiles LTW depends on

• Patient_Administration_Management (PAM) or Patient_Demographics_Query (PDQ) from ITI Technical Framework: The Actors Order Placer, Order Filler, Order Result Tracker shall be grouped with Actors from PAM or PDQ or both.
• Audit_Trail_and_Node_Authentication (ATNA) and Consistent_Time (CT) from ITI Technical Framework: The Actors Order Placer, Order Filler, Order Result Tracker shall be grouped with the Actors "Secure Node" from ATNA and "Time Client" from ATNA.

• Integration Profiles depending upon LTW

• Laboratory_Device_Automation (LDA) from the Laboratory Technical Framework: The Actor Automation Manager from the LDA Profile must also be an Automation Manager in the LTW Profile.
• Laboratory_Point_Of_Care_Testing (LPOCT) from the Laboratory Technical Framework: The Actor Order Filler from the Laboratory LPOCT Profile must also be an Order Filler in the LTW Profile.
• Laboratory_Specimen_Barcode_Labeling (LBL) from the Laboratory Technical Framework: The Label Information Provider Actor of the LBL profile shall be grouped with either the Order Filler or the Order Placer from the LTW profile.

Consumer Information

This page is based on the Profile Template