Lab Assignment Criteria

Lab Assignment Criteria (LAC) link studies to labs. When you set up a study you define the labs that will process the physical patient samples collected during the trial. The lab test Question results are then associated with the lab in the database and compared to the lab ranges defined for that lab, and when the lab test results are entered during data entry, the name of the lab that did the testing is displayed.

If necessary, you can link different labs to different RDCIs, RDCMs, subsets, layouts, study sites, Investigators, or even visits or patients.

You can update or create new lab assignment criteria if circumstances change or if new sets of assignment criteria are required while the study is in progress.

Lab assignment criteria include:

• Start Date/End Date
• Study Site
• Investigator
• DCI Name
• DCM Name, Subset and Layout
• Patient
• Clinical Planned Event Name, Visit Number

It is not necessary to complete all fields. If you leave a field blank, the lab is linked to all values for that field; for example, all sites or all Investigators. In matching lab assignment criteria to RDCMs, the system always uses the most specific set of criteria.

Each set of lab assignment criteria in the study must have a unique combination of criteria values.

A few logical restrictions apply in completing some LAC fields:

• If you enter a DCM Subset Name, the DCM name is required.
• If you enter the DCM Layout Sequence, the DCM name and subset are required.
• If you enter a DCI Name in the LAC, the list of values for DCMs will contain only DCMs that belong to this DCI; otherwise, all DCMs are valid.
• If you complete the Actual Event field, the clinical planned event is restricted to the correct event.
• Clinical planned events must be valid for the selected study.

For more information, see:

• Example of Lab Assignment Criteria Evolution
  
• Applying Lab Assignment Criteria
  
• Resolving Problems
  

Example of Lab Assignment Criteria Evolution

The following table illustrates how lab assignment criteria may evolve. Each line represents the creation of a new LAC in the same study. Each line is annotated below the table with the events that prompted the definition of a new LAC.

S.No.	Lab	Start/End Date	Site	Investigator	DCI	DCM	Patient	CPE	AE
1.	L1	-	-	VI	-	-	-	-	-
2.	L2	-	S2	-	-	-	-	-	-
3.	L3	19971202 19980115	-	VI	-	-	-	-	-
4.	L1	19971202 19980115	-	VI	LE	-	P1	-	-

1. The original LAC, created when the study began: Investigator V1 managed all patients and Lab L1 processed all lab tests.
2. A new site, S2, is added to the study. Lab L2 processes its lab tests.
3. The original Investigator, V1, is now working with a different lab, L3. Any RDCMs that come in between December 2, 1997 and January 15, 1998 are assigned to L3. If no new LAC is defined for the period following January 15, then assignments default back to the LAC on line 1, which has no date.
4. During the period when V1 is using a different lab, one of his patients, P1, continues to use the original lab, L1.

Applying Lab Assignment Criteria

In addition to storing the lab to which each lab test RDCM is assigned, Oracle Clinical stores the method by which the lab was assigned. These methods are hierarchical and you can use this hierarchy to force Oracle Clinical to reassign certain RDCMs. The following table describes the five methods in order of descending precedence.

Method	Description
USER	Explicitly assigned by user by choosing from the list of values for Lab in the Received DCMs window of the Maintain Lab Assignment Criteria window.
SYSTEM	Not currently used.
LOGIN	Lab name explicitly entered during data entry.
CRITERION	Assigned by running the Apply LAC job.
UNKNOWN	Lab is missing. Default setting.

To apply Lab Assignment Criteria to a study:

1. Navigate to Labs, and Lab Assignment Criteria. The Maintain Lab Assignment Criteria window opens.
2. Query for, then select, the study to which you want to apply LACs.
3. Click Apply LAC. The Apply LAC to Study window opens.
4. Enter a Lab Assignment Type. This selection forces a batch process to examine each lab RDCM for the study. Any that have a lab assignment type equal to or lower in precedence that the method you entered is re-evaluated and reassigned according to the current lab assignment criteria.
5. Enter a Change Reason. A list of values is available.
6. (Optional) Enter an Audit Comment about applying this LAC to this study.
7. (Optional) Select the Process Locked RDCMs box to include locked RDCMs as well. This box may be grayed out if you only have update privileges, because processing locked RDCMs requires Privileged Update. See Granting Privileged Update to a User for instructions on being granted Privileged Update.
8. Click Apply. Oracle Clinical applies the LAC to this study.

For more information, see:

• Granting Privileged Update to a User
  

Granting Privileged Update to a User

Administrators can grant you Privileged Update status in the Data Entry Configuration settings if you need to perform activities such as processing locked RDCMs.

To grant a user Privileged Update status:

1. From the Admin menu, select Users, then choose Oracle Accounts. The Maintain Oracle Accounts window opens.
2. Choose the user's account name, and select Special, and DE Configs. The Maintain User Configuration window opens.
3. For Privileged Update, choose Enabled from the list of values.
4. Save. Upon your next visit to the Maintain Lab Assignment Criteria window, you will be able to select the Process Locked RDCMs box.

Resolving Problems

Lab data may not link to ranges because an RDCM is not linked to a lab or because necessary patient information, such as age or gender, is missing. These problems—Missing Lab References in the RDCMs and Missing Data in Patient Positions—can be identified in windows reached through the buttons in the Maintain Lab Assignment Criteria window.

For more information, see:

• Missing Lab References in the RDCMs
  
• Missing Data in Patient Positions
  

Missing Lab References in the RDCMs

To identify missing lab references in the RDCMs:

1. Navigate to Labs, and Lab Assignment Criteria. The Maintain Lab Assignment Criteria window opens.

2. Choose the study that you want to investigate.

3. Click the Received DCMs button.

The Received DCMs for Study window opens; this window enables you to identify received DCMs (documents) that have either not been assigned to a lab or have been assigned incorrectly. Only RDCMs that have lab test Questions may be queried.

The Lab Assignment Type field reflects how the lab was assigned to the RDCM. If you assign a lab using this form, the system updates the Lab Assignment Type to USER. USER is hierarchically the highest method Oracle Clinical recognizes, so this lab assignment can only be changed in the future by explicit user intervention. If you make the Lab field blank here, the Lab Assignment Type is set to UNKNOWN. Each document can be associated with one and only one lab.

To query all RDCMs where the lab is blank:

1. Enter Query mode.
2. Enter LAB in the Lab field.
3. Execute the query.
4. Enter LAB IS NULL in the window.
5. Save.

Missing Data in Patient Positions

To examine patient positions where data is missing:

1. Navigate to Labs, and Lab Assignment Criteria. The Maintain Lab Assignment Criteria window opens.
2. Query for and select the study that you want to investigate.
3. Click the View Patient Positions button.

Oracle Clinical cannot compare lab test results to lab ranges if a patient's age and gender are not entered in the system. To identify patient positions with missing birth dates or gender, press the View Patient Positions button from the Maintain Lab Assignment Criteria form.

You can only query patient positions in this window; you cannot insert, modify, or delete patients.