Lab Forms support Electronic Health Record (EHR) lab data import

Before you work with this feature

To import EHR data, you must enable a study for EHR data import. For more information, see Enable a study for Electronic Health Record (EHR) data import.

Details for study designers

Study designers can now configure Lab Forms to support EHR lab data import. Previously, importing EHR lab data required study designers to create a one-section repeating form.

After the assessment environment upgrade, see Study Designer User Guide for additional information.

Consider the following when configuring a Lab Form for EHR data import.

Lab Forms support EHR mappings for Lab Test Name, Lab Result, and Lab Date of Collection.

Study designers can map the Lab Test Name field on multiple Lab Forms within a study, provided the Lab Test values selected from the EHR-Lab Test code list are unique to each Lab Form.
When you map Lab Test Name, the system prompts you to also map Lab Result and Collection Date Time. If you select Yes, the system applies the EHR mappings and displays the EHR Mapped tag.
For EHR lab data import to succeed, the Lab Test Name defined in the EHR-Lab Test code list and the Lab Unit defined for the Lab Result question must match the corresponding values in the EHR lab results.
After a study version is moved from the Draft container, adding, updating, or removing EHR mappings is permitted only as part of a study version change. Advanced Study Versioning (ASV) does not support EHR mapping changes.
When an EHR lab result includes a Collection Date, the system uses it to populate the Collection Date Time field. If you hide the Collection Date Time field in the Lab Form design, EHR lab import is blocked unless the importing user has permission to view hidden fields through data classification settings.

Note:
If multiple effective-dated lab normal ranges are configured for a lab, Clinical One Cloud Service uses the Collection Date to determine which lab normal ranges apply to the imported lab results.
When Allow for Multiple Instances is enabled on the Lab Form, EHR lab results from different collection dates can be imported into separate lab form instances. If multiple instances are not allowed, only one collection-date group can be imported at a time.

Details for site users

Before selecting Import EHR Data, you must choose a local lab from the Select Lab drop-down list. After selecting a lab, the Lab Form displays the lab normal reference ranges defined in Clinical One Cloud Service for the selected lab. The displayed ranges are based on the subject's age, gender, and race. The system notifies you if any required demographic data is missing. Complete the missing fields before importing the EHR lab data.

Note:
Lab Units, low and high ranges, and normal text result details included in the EHR lab results do not overwrite the values defined in Clinical One Cloud Service for the selected lab. These values are informational only.
If the lab test name or the lab unit included in the EHR lab results do not match the corresponding values configured in Clinical One Cloud Service for the selected lab, the system does not import the lab result.
If the low or high range values included in the EHR lab results do not fall within the ranges defined in Clinical One Cloud Service for the selected lab, the system does not import the lab results.
When an EHR lab result includes a Collection Date, the system uses it to populate the Collection Date time field. EHR lab import is blocked when the Collection Date Time field is hidden.
EHR lab observations are grouped by collection date and time. Lab results from the same observation are imported into the same Lab Form instance and populate the corresponding Lab Test rows.
If the Lab Form setting Allow for Multiple Instances is enabled, lab results from different collection-date groups can be imported into separate Lab Form instances. If multiple instances are not allowed, only one collection-date group can be imported at a time.

Impact on existing studies configured for EHR data import

Existing one-section repeating forms configured for EHR data import continue to be fully supported. Existing mappings, imported data, audit history, reports, extracts, and reimport behavior remain unaffected. Study teams are not required to migrate to the Lab Form type.