Defining Standard Lab Ranges

Defining Textbook Ranges

Textbook lab range definitions serve as the company standard range for lab test Questions. They provide a default definition for each lab test Question where no lab-specific ranges have been defined. You can also use these definitions as a foundation from which to create more specific lab range definitions for particular labs.

Oracle Clinical enforces uniqueness for textbook ranges in a similar way to lab ranges, but considers one more column: the Lab Unit Name. Thus, each textbook range must be a unique combination of lab test Question, Domain, Sex, Maximum Age, Minimum Age, Effective Start and End Date, and Lab Unit Name.

The Maintain Textbook Ranges window only displays the representative unit names. Representative Lab Test Units are defined when you define lab test Question units; see Defining lab test Question Units.

You can use the Maintain Textbook Ranges window to delete textbook ranges; however, you cannot delete a textbook range if a Preferred Copy Group uses it.

To define a textbook range:

Navigate to Labs, then Labs, and Textbook Ranges. The Maintain Textbook Ranges window opens.
Query for the Question for which you want to establish textbook ranges. The system displays only Questions that have a Question type of Lab Test.
Enter each textbook range for this Question:
1. Enter the gender to which this range applies. Valid choices are Male (M), Female (F), or Both (B).
2. Enter the minimum and maximum age ranges. You can leave either end of the age range blank, if no minimum or maximum age applies for this range.
3. Enter the low and high values for this textbook range, and the Lab Unit Code for the measurement you are specifying.
4. (Optional) Enter the dates during which the textbook range is in effect. You can leave one or both of these blank.
Save. Oracle Clinical commits these textbook ranges to the database for this lab test Question.

Parent topic: Defining Standard Lab Ranges

Defining Preferred Copy Groups

A Preferred Copy Group is a named set of lab test Questions and the units of measure that each question uses. Using Preferred Copy Groups enables you to create and copy groups of textbook ranges; each time you add a lab test Question to a Preferred Copy Group and choose a preferred unit of measure, Oracle Clinical associates the textbook ranges you have defined for that Question with the copy group. When you copy textbook ranges into a lab definition, the Use Textbook Ranges window only allows you to use textbook ranges that are grouped into Preferred Copy Groups.

You can create Preferred Copy Groups to group Questions that often need to be copied together when applying ranges to a lab; or for lab test Questions that are identical except for, perhaps, the unit of measure measured.

Differences in units of measure arise when you have locations in Europe and also in the United States. To handle these differences you might have a Preferred Copy Group called US and one called EURO. For example, the Hematocrit test would likely be collected as a fraction in Europe and as a decimal in the U.S., which you would translate as two identical textbook range definitions for Hematocrit:

Hematocrit    	Male	    42-54	     %        	   Female	    38-46 	    %
Hematocrit	    Male	    .42-.54	   fraction	    Female	    .38-.46   	fraction

Preferred Copy Groups and Preferred Conversion Groups (from the Labs menu, select Lab Units, then Pref Conv Groups) take almost the same information about lab test Questions and their preferred units of measure, but are used for different things. Conversion groups are used by Derivation Procedures and copy groups are used to copy lab Questions and their preferred unit and textbook range for use in a new lab; see Defining Preferred Copy Groups and Defining Preferred Conversion Groups.

To define a Preferred Copy Group:

Navigate to Labs, then Labs, and Pref Copy Group. The Maintain Preferred Copy Group window opens.
Enter a unique ID for this group. This ID can be up to 10 characters long.
Enter the name for this group. This name is required, but you can change it even after you save the Preferred Copy Group.
(Optional) Enter a comment with supplementary information about the Preferred Copy Group.
Enter each lab test Question and its preferred Lab Unit combination that you want to include in this Preferred Copy Group:
1. Query for the lab test Question. When you choose one, the Maintain Preferred Copy Group window also populates its domain.
2. Query for the Lab Test Unit you want to use for this Question.
3. (Optional) Enter a supplementary comment about including this Question and unit in the Preferred Copy Group.
Save. Oracle Clinical commits this Preferred Copy Group to the database, making it available for use in the Use Textbook Ranges window.

Parent topic: Defining Standard Lab Ranges

Defining Lab Panels

To define a lab panel:

Navigate to Labs, then Labs, and Lab Panels. The Maintain Lab Panels window opens.
Define a unique identifier for the lab panel, not greater than 10 characters, in the Panel field.
Define a unique name for the lab panel, not greater than 60 characters, in the Panel Name field.
(Optional) Enter a comment to describe this lab panel. Descriptions in this field can be useful to other users browsing through lab panel records.
Enter the lab test Questions for this lab panel in the lower part of the window. For each lab test Question:
1. Click in an empty row. The Maintain Lab Panels window populates the sequence number (Seq #) field with the next unused number.
2. Enter a SAS Name for a Question defined and active in the Global Library with data type NUMBER and type LAB TEST.
  
  When you choose a Question, Oracle Clinical automatically populates the lab test Question and lab test Question Domain fields with the corresponding information for that SAS Name.
3. Choose a lab test Question Type.
4. (Optional) Enter a comment about including this lab test Question in the Lab Panel.
Save.

You can modify existing lab panels in a similar way. Query for the lab panel you want to change using the fields in the upper part of the window, and add, remove or change lab test Questions.

Parent topic: Defining Standard Lab Ranges

Defining Labs

This section describes how to define the basic lab settings using the Maintain Labs window. A Lab Definition consists of the necessary contact and related information, and the lab ranges to be applied to data from that lab. You have to define the information in this section before you establish the lab's ranges.

Use the Maintain Labs window to launch these tasks: define lab ranges and lab range subsets, use textbook ranges in the lab definition, and copy lab ranges.

You can also delete labs using the Maintain Labs window; however, you can only delete a lab if it is not referenced by any received DCMs or lab assignment criteria.

To define a lab:

From the Labs menu, select Labs, then Labs. The Maintain Labs window opens.
Enter the Lab ID and its name. The ID must be no greater than 10 characters, all uppercase.
Select the Active? box to activate the lab, or clear it to render it inactive. Only active labs can supply lab ranges for the lab data entered or batch loaded for a study. You can change a lab's active status at any time.
Ranges Approved: If this field is checked, all ranges for this lab have a status of Approved. This is a display-only field.
Format Mask: Choose the default file format mask you want to use for batch loading data from this laboratory.
Owning Location: Name of the Oracle Clinical database that owns this lab data. This is a display-only field.
Replicate?: If checked, this lab must be replicated from an Oracle Clinical database other than your current database.You can change this flag from unchecked to checked at any time, but once checked, you cannot uncheck it.
Last Replication: Date and time this lab was last replicated from the Oracle Clinical owning location. This is a display-only field.
Enter the necessary information for the person who serves as the contact for this lab: the contact's first and last name, phone number and fax number.
Enter the lab's full mailing address.
Enter the start and end dates for this lab's accreditation.
Enter the certification agency and number for this lab, if applicable.
(Optional) Enter a supplementary comment to describe this lab.
Save. Oracle Clinical commits this lab definition to the database.

Parent topic: Defining Standard Lab Ranges

Defining Specific Lab Ranges

Use this window to specify ranges for this lab that are different from your company's textbook range for particular Questions.

As in textbook ranges, you can define a different range of valid values for each Question depending on the age or gender of the patient. Each range in the lab must have a unique combination of lab test Question, sex, maximum age, minimum age, and effective start and end date. If any range definition has a blank field for Lab Unit, low range, or high range, the range status is automatically set to MISSING, in which case the range is considered incomplete and not used for calculations.

The ranges you define here, and only the ranges you define here, will be available for Subsets definition (see Defining Lab Subsets).

For a special use of the Ranges window, see Using Textbook Ranges.

Note:

If you change any part of a lab range definition that has been used against production data, you must immediately execute the PSUB job; from the Labs menu, select Lab Procedures Re-Execution Pre-Process. If you do not run this job, your changes will not be applied to existing data.

For more information, see:

Parent topic: Defining Standard Lab Ranges

Age

If you enter a value in the optional Age field, the value must be greater than zero. The minimum age is inclusive, and maximum age is exclusive. For example, an age span of 10 to 20 years would apply to patients from the day they turn 10 years old through the day before their twentieth birthday. When they turn 20 this lab range would no longer apply to their data for this Question. A set of age spans for ranges for a particular lab test might be 10-20, 20-30, 30-55. These spans do not overlap. Ages may be expressed in days, months, or years; the Age Unit field is to the right in the window.

Parent topic: Defining Specific Lab Ranges

Effective Date

Unless there is a specific date entered in either the Start or End field, the range is assumed to be continuous from the point it is defined. If you enter an end date, then you must define a range to start after that; otherwise the textbook range becomes the active range.

Two ranges can coexist if describing ranges for patients of different ages:

Table 15-1 Example of Non-conflicting Date Ranges

Lab Test Question	Sex	Minimum Age	Maximum Age	Minimum Age Unit	Maximum Age Unit
CHOLESTEROL_SERU	B	10	20	YEARS	YEARS
CHOLESTEROL_SERU	B	20	30	YEARS	YEARS
CHOLESTEROL_SERU	B	30	55	YEARS	YEARS

The Effective Date and Sex fields are all components of the unique key for the range. In the example below the two ranges conflict because the unique key components overlap—that is, sex (because Both includes Men) and the date ranges overlap by one day. The ages do not overlap because the age units are different. Also, note that the units of the minimum and maximum can be different from each other, as well as different from the previous row.

Table 15-2 Invalid Sex and Effective Date Values

Lab Test Question	Sex	Minimum Age	Maximum Age	Effective Start Date	Effective End Date	Minimum Age Unit	Maximum Age Unit
ALBUMIN_SERUM	B	30	40	-	19980101	DAYS	DAYS
ALB UMIN_SERUM	M	32	38	19980101	-	MONTHS	YEARS

Parent topic: Defining Specific Lab Ranges

Lab Range Records without Effective Start or Effective End Dates

If you enter a lab range record and leave either the Effective Start or Effective End Date field empty, the Lab Ranges window leaves that field blank when you save the record. However, Oracle Clinical does store a date value in the database for that record. The presentation of this date value in SQL*Plus can be counter-intuitive, so this section describes how Oracle Clinical stores this information.

If you leave the Effective Start Date field empty, Oracle Clinical stores the date January 1, -4712 in the effective start date column for that record. This date is 1 Julian, which is the beginning of time for an Oracle database. When you query for the record, SQL*Plus removes the negative sign from the year, displaying the values as 01-JAN-4712 or just 01-JAN-12. Despite the presentation, Oracle Clinical logically handles lab range records in this format as having no effective start date.

Similar logic applies to the Effective End Date. When you leave this field empty for a lab range record, Oracle Clinical stores the end date as August 15, 3501. This date is 3,000,000 Julian, and represents the end of time for an Oracle database. Depending on the date formats you use for SQL*Plus, the system might display lab ranges without effective end dates as having an end date of "15-AUG-3501."

Parent topic: Defining Specific Lab Ranges

Defining Lab Ranges Using the Maintain Lab Ranges Window

To define a lab range:

Open the Maintain Labs window (from the Labs menu, select Labs, then Labs) and query for the lab you want to modify.
Click the Ranges button. The Maintain Lab Ranges window opens.
For each lab range you want to define:
1. Query for the lab test Question for this lab range. When you select a Question, the window displays its domain and the Range Type (which is the source of the range, and is either LAB or TEXTBOOK).
2. Choose the gender to which this range applies. Values are Male (M), Female (F), or Both (B).
3. Enter the minimum and maximum age ranges. You can leave either end of the age range blank, if no minimum or maximum age applies for this range.
4. Enter the low and high values for this textbook range, and the Lab Unit code for the measurement you are specifying.
5. (Optional) Enter the dates during which the textbook range is in effect. You can leave one or both of these blank.
Save. Oracle Clinical saves these lab ranges for this lab definition.

Parent topic: Defining Specific Lab Ranges

Defining Lab Subsets

Oracle Clinical enables you to create (optional) subsets of existing lab ranges, which you can use for particular lab Questions where the normal range is affected by a predictable factor. For example, diabetes consistently influences the range of data considered normal for certain Questions.

To prepare for subset creation, when you define a lab Oracle Clinical creates it with a single default subset. When you define ranges for a lab, Oracle Clinical automatically associates them with the default subset as well. These are the only ranges that are available to other subsets for the lab.

Before creating subsets you must enter the values you plan to use for subset names in the LAB RANGE SUBSET CODE installation reference codelist. If you define no explicit subsets then the lab will have only one, lab_name$default. The name assigned to the default is also specified in the LAB RANGE SUBSET CODE reference codelist.

You also define these lab range subsets in the Lab Range Subsets window. When you create a subset, you are required to select the Questions from a list of the Questions included in the default subset. The default subset is created automatically when the lab is created. Subsets have the syntax lab_name$subset_name when a lab is referenced elsewhere in the system.

For more information, see:

Parent topic: Defining Standard Lab Ranges

Defining the Subset Name

In this section, you establish the subset you want to use for this lab. To define a Lab Range Subset:

Open the Maintain Labs window (from the Labs menu, select Labs, then Labs) and query for the lab you want to modify.
Click the Subsets button. The Maintain Lab Range Subsets window opens.
Click in an empty row, and choose a Subset Code from the list of values. The window populates a default name for the subset, which you can modify at any time.
Select the Active? box to use this subset in the lab range, or clear it to prevent its use at this time. You can change this setting at any time.
Save. Oracle Clinical saves the subset name for this lab. Proceed to Defining the Subset Range Values.

Parent topic: Defining Lab Subsets

Defining the Subset Range Values

In this section, you specify the subset values for a particular lab range. There are two ways to do this:

You can enter the subset ranges manually. From the Lab Range Subsets window, click Ranges, then enter the ranges as you would for the default subset.
You can copy a set of ranges from the default subset, then edit them for the new subset.

To copy ranges from the default layout:

In the Lab Range Subsets window, confirm that the subset that you want to use is selected, then click Ranges.
In the Ranges window, click Copy Ranges from Default Subset. The Multiple Questions Selection from the Default Subset window opens.
Choose one or more Questions to include, and click OK. This window closes, and the ranges window adds all of the default lab ranges you selected to the subset.
Edit each subset range to include the values you want.
Save. Oracle Clinical saves this subset for the lab.

Parent topic: Defining Lab Subsets

Using Textbook Ranges

The List function in the pop-up window displays available copy groups. The New Dates Start/End field in the Use Textbook Ranges window substitutes for the original effective dates of each of the textbook ranges. If the textbook ranges have changed over time, the Text Range Date field lets you copy older textbook ranges.

You can copy a whole set of lab Questions, their preferred units of measure, and predefined company-standard textbook ranges (see Defining Textbook Ranges) by clicking the Textbook Ranges button and entering the name of a Preferred Copy Group (see Defining Preferred Copy Groups).

Note:

If you want to associate a textbook range for a unit with a particular Question rather than a whole set of Questions, from the Labs menu, select Labs, then Labs. Select the Ranges button. In the Ranges window that appears, enter the Question with which you want to associate a textbook range. Oracle Clinical populates the LOVs of the enterable fields, such as Min or Low under Age or Values, with textbook range values.

To use textbook ranges in a lab:

From the Maintain Labs window (from the Labs menu, select Labs, then Labs), choose the lab for which you want to use textbook ranges.
Click the Use Textbook Ranges button. The Use Text Book Ranges window opens.
Select a Preferred Copy Group to use. Oracle Clinical will copy this group's test Questions, ranges and units into this lab.
If you want to use the current version of the textbook ranges, leave the remaining fields empty and click OK.

If you want to use earlier versions of the textbook ranges, enter a date when this textbook range was current in the Text Range Date field. You can only use previous versions of textbook ranges if these ranges are still active.
Enter the dates over which the copied ranges will be effective. Dates must be in the YYYYMMDD format.
Click OK to close the Use Text Book Ranges window, then save.

Parent topic: Defining Standard Lab Ranges

Copying Lab Ranges

If you are creating a new lab definition for a lab that will perform a set of lab tests very similar to an existing lab, you can copy a whole set of lab ranges from another lab definition by pressing the Copy Lab Ranges button and choosing a valid lab to copy from. You can then edit the ranges, if necessary. You cannot edit them once the new lab has been used.

To copy lab ranges from another lab into the lab you have selected:

In the Maintain Labs window (from the Labs menu, select Labs, then Labs), choose the lab into which you want to copy lab ranges.
Click the Copy Lab Ranges button. The Copy Lab Ranges window opens.
Choose the lab from which you want to copy ranges, and click Copy.

The operation generates Alert messages, which list the number of ranges copied, number rejected, and which Questions were not copied because of a conflict. Lab ranges that copy successfully will appear in the selected lab with a Range Type of LAB and a Comment of COPIED.
Save.

Parent topic: Defining Standard Lab Ranges