Lab Methods (LIMS)

A lab method defines which lab result records and lab input records (such as instruments or consumables) LIMS needs to generate when a Lab Test is created. The result definitions and method inputs essentially reflect what the lab method procedure requires to be captured during test execution.

Static Data Admins build Lab Methods independently, and then reference them in Lab Sample Definitions in protocol records. Lab Methods are also used in Lab Specifications, whereby the Lab Specification Criteria records target specific Lab Result Definitions from Lab Methods in the selected protocol.

Lab Method Version Control

Lab Method records are subject to Vault LIMS version control. Once these records enter the Effective lifecycle state, they cannot be edited. Instead, you must create a new version using the Create New Version action on the record.

When a lab method is created, Vault automatically creates an associated Lab Method Group record in the background. This Lab Method Group record tells LIMS that these records are versions of the same lab method, and is used to display the Version History section on your Lab Method record.

If you make a new Lab Method version effective, note that this could have a wide-reaching impact on everything referencing the prior version, such as Sample Definitions in protocols, and Lab Specification Criteria in Lab Specifications.

Creating Lab Methods

To create a new lab method, you must first ensure you have all the Units of Measure you’ll need for each Lab Result Definition you wish to define.

Lab Methods are a collection of Lab Result Definitions, and Lab Method Inputs, which form the basis of how Vault creates Lab Tests during Lab Sample initiation.

Creating Lab Methods

To create a Lab Method record:

  1. Navigate to Business Admin > Lab Methods, or to a custom object tab.
  2. Click Create.
  3. Enter a Name.
  4. Optional: Enter an Estimated Duration.
  5. Optional: Select a Procedure Document. This determines which document is shown side-by-side with the lab results grid in the test execution page. Note that you are selecting a document, and not a specific document version in this step, but Vault selects the latest steady state version of this document during test execution.
  6. Click Save.

Add Lab Result Definitions to your Lab Method

Each Lab Method contains one or more Lab Result Definitions, which Lab Results are created from at runtime. Lab Result Definitions contain many attributes that determine how the Lab Result will be displayed, how the data will be entered, what values it will accept, and even how the values will be presented back to the lab analyst in the test execution page.

To create a Lab Result Definition:

  1. Navigate to the Result Definitions section of a Lab Method record.
  2. Click Create.
  3. Select a definition type from the drop-down. Some types have additional requirements:
    • Numeric Result: For numeric results, you must select a Notation (standard or scientific eNotation) and Rounding Rule (USP, ASTM), and enter the number of Significant Figures (or decimal places) for the value. This is to help format the result for display purposes during test execution. This is the only type which can be a calculated result.
    • Picklist Result: For pickist results, you must select a Lab Result Picklist record from the drop-down, which determines the picklist from which the lab Analyst will select a picklist value during test execution. This is a LIMS object, not the platform Picklist component.
    • Text, Date, and DateTime Result
  4. Enter a Name. This is how the Lab Result label will appear in the test execution grid.
  5. Enter an Order. This determines positioning among the other results in the test execution grid.
  6. Select a Data Entry Method:
    • Manual: Allows the user to input the value during test execution.
    • Integration: The value is drawn from data via Vault integrations.
    • Calculation: The value is the result of a predefined calculation. This entry method is only available for the Numeric Result definition type.
  7. Select the Required? checkbox to require that the value is populated before moving the test to review.
  8. Click Save.

Optionally, you can create Lab Method Step records to group and order those results.

Creating Lab Method Steps

If any lab method steps exist in the lab method, all result definitions must have a Lab Method Step selected before the Lab Method record can be made Effective.

To create a Lab Method Step:

  1. Navigate to the Lab Method Step related object section of a Lab Method record.
  2. Click Create.
  3. Enter a Name.
  4. Enter a Step Order. This value determines step positioning during test execution.
  5. Click Save.

Add Lab Method Inputs to your Lab Method

In addition to Lab Result Definitions, you can also define the Lab Inputs that should be captured during test execution. These include specific instruments and consumables that should be used in the lab test.

About Material Lab Result Picklists

Unlike standard Vault picklists, Material Lab Result Picklists are object records, populated with related Lab Result Picklist Option records.This allows you to define what picklist options are available to the user for this specific Lab Result when they’re executing a Lab Test.