Using Lab Ranges

You set lab ranges to define medically appropriate values for Question responses. A Question's lab range may vary according to a patient's age or sex. You can create a Procedure to check if a response falls into the range defined for its Question, creating a discrepancy if it does not. To reference lab ranges in a Procedure:

• In the Procedure Definitions window, select the Lab Range Dependent? box. If you select this box and then run the PSUB job Lab Procedures Re-execution Pre-process (under the Labs navigation path) after changes are made to lab ranges or lab range subsets, any Procedures that reference Questions with changed lab ranges will be re-executed for all patients during the next batch validation. This functionality is available in V3.1-style Procedures only. See Lab Procedures Re-execution Pre-process Job Limitations below.

  • If responses are no longer discrepant, according to the new range definition, associated discrepancies are obsoleted.

  • If responses are now discrepant, the system generates new discrepancies.

• In the Procedure Questions window, select the Include Lab Range? box for a Question that is defined with a Question type of Lab Test .

  When a lab-dependent Procedure is executed, the system executes an internal function that brings lab range information into four system variables (High, Low, Unit, and Not Found) for each record fetched. See Aggregate and Lab Attribute Variables.

  Note:

  The function requires a value for DCM_DATE. If the lab range is date- or age-dependent, the function uses the entered DCM date to identify the correct range for the patient's data. Even if the lab range is not date- or age-dependent the DCM date is required.

  You can ensure that a DCM_DATE value is available by enabling the Data Entry Configuration setting DCI and DCM Date Required, and either checking Use DCI Date? for the DCI Module containing the lab Questions or entering the DCM date during data entry.

• In a Procedure detail expression, reference one or more of the lab-related system variables.

For example:

You could define a nonaggregate Procedure Question Group PHARMACOKINETIC, alias PK, with a Procedure Question named HEMOGLOBIN. You can check the high and low ranges for hemoglobin, given the patient's age and sex, using the variables PK$hemoglobin$hi and PK$hemoglobin$lo. These variables are populated from the values in the Lab Reference Range system.

Different users may enter responses to lab range Questions in different units, and the units associated with the high and low values in the Lab Ranges system may not match the user-entered units. For this reason, it is important that Procedure designers not write Procedures that depend on values being expressed in the same units. Oracle Clinical creates a system variable to contain the unit of the ranges given by the Lab Reference Range system, for example:

PK$hemoglobin$un

No unit conversion (normalization) facility in Procedures exists, but you can convert and store values with custom code and user variables. You can write Procedures that compare values only when the units match. For example:

PK.hemoglobin > PK$hemoglobin$hi * 1.1 and PK.hemo_unit = PK$hemoglobin$un

The expression above creates a discrepancy when the hemoglobin count is higher than the upper lab range value by 10%, only if it is expressed in the same units.

In this example, you must define the Question Hemo_unit in the PK Question Group, to collect the unit in which the response is entered. You must also select the Question variable based on Hemo_unit in the detail expression.

Lab Procedures Re-execution Pre-process Job Limitations

The Lab Range Re-execution Pre-process job does not obsolete discrepancies and create new ones in the following circumstances:

• When changes are made to RDCM keys, except for the keys: Patient, Clinical Planned Event, and Subevent Number.

• When the Lab Range is changed in such a way that it no longer applies to a patient record. For example, if the Effective End Date is changed to a date before the patient data was collected, the job does not process the record and does not make the discrepancy obsolete.

• When the Question tested by the Procedure is removed from the lab definition.