Maintaining Specifications for Standard Use

• Maintaining Specifications for Standard Use
  • Numeric and Numeric Only Analytes
  • Text Analytes
  • Inheriting the Standard Specification upon the Registration or Creation of a Blank, Standard or Spike Sample
  • Use of Standard Specifications during Data Entry
    • Specification Status
  • Use of Standard Specifications during Reporting
  • Exporting Specifications associated with Standards

A standard specification is a set of internal assessment and reporting limits for scheme version analytes used to define the target, warning and failure limits (QC limits) for a blank, standard or spike QC sample made from the material associated with a standard lot.

Specifications are created using the CCSPFN—Specification application, which is also accessed using the Analysis Setup » Specifications menu option.

Standard specifications are assigned to standard lots using the CCSTND—Standard application using the options in the Lot Specifications tab.

Where lines of business (LOB) are implemented, only specifications within schemes belonging to the same LOB as a laboratory can be used (those outside of the laboratory's LOB are not visible to users of the laboratory).

Schemes available for adding as a limit are displayed in a drop-down list. Refer to the Effect of Scheme Scope when Adding Specification Limits.

Specifications are scoped by type: standard, scheme limit, and product. This process covers those scoped by standard.

Standard specifications are created either with org-scope or lab-scope. An organisation or laboratory can contain multiple specifications.

Numeric and Numeric Only Analytes

Where the scheme version analyte has an Analyte Data Type of Numeric or Numeric Only, accuracy assessment uses the specification scheme version analyte's internal absolute limits, where the warning and failure ranges are absolute.

There is the option to enter these limits as relative values, where a percentage around the target value for warning and failure limits is designated, however, the system determines the equivalent absolute values and uses them for the accuracy assessment.

A specification scheme version analyte unit's numeric limits are bound by any or all of the following:

• < or = Internal Minimum Value—The lowest acceptable amount of substance for the specification to be satisfied, below which the material would fail the standard lot's specification.
• < or = Internal Minimum Warning Value—The lowest acceptable amount of substance for the specification to be satisfied without warnings, below which the material would satisfy the standard lot's specification but with warnings.
• Internal Target Value—The target value for the acceptable amount of substance in the material.
• > or = Internal Maximum Warning Value—The highest acceptable amount of substance for the standard lot's specification to be satisfied without warnings, above which the material would satisfy the specification but with warnings.
• > or = Internal Maximum Value—The highest acceptable amount of substance for the standard lot's specification to be satisfied, above which the material would fail the specification.

The method used to determine the percentage difference between an expected and observed value for accuracy assessment is set by preference. See how to Set the USE_STD_TARGET_FOR_PERCENT_DIFFERENCE application preference.

Text Analytes

Where the scheme version analyte has an Analyte Data Type of Text, the specification can be configured to assess strings with or without case-sensitivity.

Inheriting the Standard Specification upon the Registration or Creation of a Blank, Standard or Spike Sample

Where a standard lot is linked to a standard specification, when the standard and its current standard lot is applied to a blank, standard or spike sample, then the sample is linked to the standard specification.

Use of Standard Specifications during Data Entry

Where a sample has a primary or secondary analytical type of blank, standard or spike, when a result is entered for a sample, then the result is assessed against the internal limits within the sample's standard specification, for the matching scheme, version, analyte and the sample scheme analyte's Unit Code, to set the sample scheme analyte's Standard Status. This status rolls into the sample scheme analyte's Composite QC Status.

Specification Status

Specifications have a tri-state activity statuses:

• Draft
• Active
• Suspended.

The flows are:

• Activate: Draft --> Active or Suspended --> Active
• Suspend: Active --> Suspended.

The difference between a draft and suspended specification is minor: both states prohibit the selection of the specification on a drop-down choice. However, suspension implies the specification was previously active and now should NOT be used, whereas draft implies that the specification is still undergoing checking and validation processes so is not yet ready for use by the laboratory. This only can occur after activation.

When deactivating or suspending a specification, the user is given the option to enter a reason as to why the action is being performed.

Use of Standard Specifications during Reporting

When a QC sample is included in a report, the reporting limits within the related standard specification are available for inclusion in the report result set.

Exporting Specifications associated with Standards

When a standard is approved for export and subsequently imported, then any specification associated with the standard lots are approved automatically for export and imported also.