CCSPFNANA—Specification Scheme Analyte Detail
Processes associated with this form
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Maintaining Analytical Limits for a Scheme Limit Specification
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Maintaining Analytical Limits for a Specification for Standard Use
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Maintaining Analytical Limits for a Specification for Product Use
Screen flows
- Submit—Validate and save the changes.
- Refresh—Reloads the original data. Any changes made since the last submit are lost.
- New—Create a new item related to the application.
- Save As—Creates a new item based on the information provided by an existing item.
- Delete—Confirm and delete the current item.
Header
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Organisation Scope
Indicates whether this entity is available organisation-wide or laboratory-wide.
- Checked—The entity is available to users who are logged into any laboratory within the organisation.
- Unchecked—The entity is only available to users who are logged into the current laboratory.
Setting the specification scheme analyte's scope upon successful creation depends upon the user's security level for the CCSPECIFICATIONSCHEMEVERSIONANALYTE:CREATE resource. The possible security levels for the resource, from greater scope to lower scope, are:
- full—full
- 3—LAB AND ORG
- 2—ORG ONLY
- 1—LAB ONLY
A user can have multiple roles, and each role can contain different rights. Any of these role-right combinations may contain the resource.
If the resource does not exist across all role-right combinations for the user, then the user has no access to the resource. Otherwise the user's security level for the resource is determined as the greatest scope across all role-right combinations for the user. For example, if a user has Role1 that contains RightA, and Right A contains security level 2 for the resource, and the same user has Role2 that contains RightB, and RightB contains security level 1 for the resource, then the user has a security level of 2 for the resource.
The selection in this field can determine the visibility for other fields in this form, and the content of various drop-down selection lists.
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Scheme Code
The code of the scheme on the specification.
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Version Number
The version number of the scheme on the specification.
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Analyte Code
The code of the analyte on the specification.
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Analyte Data Type
The type of data expected for the analytical result for the analyte. Display only. This can be:
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Numeric Only—A numeric value is expected; only numeric result values are stored.
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Numeric—A numeric value is expected, however, depending on permissions, a string value can be entered; only a numeric result or string result is stored.
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Text—A text string is expected; a string result is stored.
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Boolean—0 or 1 is expected; a Boolean result is stored.
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Date—A date string is expected (for example, 01/12/2014); a date result is stored.
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Datetime—A date-time string is expected (for example, 01/12/2014 14:15:11); a date-time result is stored.
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Image—An image upload is expected; the image result points to the EFS file containing the image.
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Document—A document upload is expected; the document result points to the EFS file containing the document.
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Unit Code
The code of the unit of comparison on the specification.
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Description
The description of the specification limit.
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Limit Check Method
The method by which the limits are entered:
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Absolute
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Relative
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List
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By Script (Reserved for future use)
Different fields display depending on the option. If the Limit Check Method is either Absolute or Relative, then numeric fields are optional.
During the update of a standard Specification type, if the Limit Check Method is toggled between Relative and Absolute, then all values for the numeric fields are preserved regardless of whether they are visible on the UI.
During the update of a standard specification type, if the Limit Check Method is Absolute, then all the numeric fields can be manually edited including those that are previously calculated.
If the Limit Check Method is Relative, then the values in the non-displayed fields are preserved.
Internal Percentage Warning Value = 1.96 / 3.09 x ( ( 100 x scheme version analyte's Rep Statistical Detection Limit / Internal Target Value ) + scheme version analyte's Rep Limiting Repeatability)
Internal Percentage Failure = (100 x scheme version analyte's Rep Statistical Detection Limit / Internal Target Value ) + scheme version analyte's Rep Limiting Repeatability)
Report Percentage Warning Value = 1.96 / 3.09 x ( ( 100 x scheme version analyte's Rep Statistical Detection Limit / Report Target Value ) + scheme version analyte's Rep Limiting Repeatability)
Report Percentage Failure Value = ( 100 x scheme version analyte's Rep Statistical Detection Limit / Report Target Value ) + scheme version analyte's Rep Limiting Repeatability
Note: Limits are assessed against the entered or calculated absolute values.
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Critical for Validation
When the system is assessing a sample scheme analyte's Specification Status, it sets the SSA's Specification Status by considering the sample scheme analyte specification's Specification Status for the sample's Primary Specification, such that, where the specification scheme version analyte unit's Critical for Validation is selected, then sets it to the sample scheme analyte specification's Specification Status, otherwise sets it to Not Required.
Confidence Category
A category assigned to the specification limit with respect to confidence in the limits. Selected from categories with a Category Type of CONFIDENCE.
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Text Spec Case Sensitive
Indicates whether the test of the sample scheme analyte's result is case-sensitive against the items in the specification list.
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Specification List (1 per line)
The list of accepted text strings for validating a text result of a sample scheme analyte.
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Recalculate Internal Limits
Indicates whether a sample specification's absolute limits for QC assessment are recalculated from relative limits.
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Internal Min Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The minimum value, at, or below, which a lower failure occurs for limit assessment, and where the check box is:
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Checked—The value is included within the minimum failure range, such that, any result less than or equal to the limit returns a Lower Failure.
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Unchecked—The value is not included within the minimum failure range, such that, any result less than the limit returns a Lower Failure.
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Internal Min Warning Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The minimum warning value, at, or below, which a lower warning occurs for limit assessment, and where the check box is:
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Checked—The value is included within the minimum warning range, such that, any result less than or equal to the limit returns a Lower Warning.
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Unchecked—The value is included within the minimum warning range, such that, any result less than the limit returns a Lower Warning.
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- Internal Target Value
The target value for limit assessment.
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Internal Max Warning Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The maximum warning value, at, or above, which an upper warning occurs for limit assessment, and where the check box is:
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Checked—The value is included within the maximum warning range, such that, any result equal or greater than the limit returns an Upper Warning.
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Unchecked—The value is included within the maximum warning range, such that, any result greater than the limit returns an Upper Warning.
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Internal Max Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The maximum value, at, or above, which an upper failure occurs for limit assessment, and where the check box is:
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Checked—The value is included within the maximum failure range, such that, any result equal or greater than the limit returns an Upper Failure.
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Unchecked—The value is included within the maximum failure range, such that, any result greater than the limit returns an Upper Failure.
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- Internal Percentage Warning Value
Only displayed where the Limit Check Method is Relative.
The relative percentage difference from the Internal Target Value below and above which a lower warning occurs for limit assessment.
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Internal Percentage Failure Value
Only displayed where the Limit Check Method is Relative.
The relative percentage difference from the Internal Target Value below and above which a lower failure occurs for limit assessment.
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Reportable Limits
The description of the reportable limits for the analyte on the specification. Defaults to a concatenation of the individual reportable limits.
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Is Reportable
Indicates whether the specification limits and assessment for the analyte on the specification are included in a report record set.
- Recalculate Report Limits
Indicates whether a sample specification's reportable absolute limits are recalculated from relative limits.
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Report Min Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The minimum value, at, or below, which a lower failure is reported, and where the check box is:
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Checked—The value is included within the minimum failure range, such that, any result less than or equal to the limit returns a Lower Failure.
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Unchecked—The value is not included within the minimum failure range, such that, any result less than the limit returns a Lower Failure.
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Report Min Warning Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The minimum warning value, at, or below, which a lower warning is reported, and where the check box is:
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Checked—The value is included within the minimum warning range, such that, any result less than or equal to the limit returns a Lower Warning.
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Unchecked—The value is included within the minimum warning range, such that, any result less than the limit returns a Lower Warning.
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- Report Target Value
The reportable target value.
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Report Max Warning Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The maximum warning value, at, or above, which an upper warning is reported, and where the check box is:
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Checked—The value is included within the maximum warning range, such that, any result equal or greater than the limit returns an Upper Warning.
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Unchecked—The value is included within the maximum warning range, such that, any result greater than the limit returns an Upper Warning.
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Report Max Value and Inclusive Flag
Only displayed where the Limit Check Method is Absolute.
The maximum value, at, or above, which an upper failure is reported, and where the check box is:
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Checked—The value is included within the maximum failure range, such that, any result equal or greater than the limit returns an Upper Failure.
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Unchecked—The value is included within the maximum failure range, such that, any result greater than the limit returns an Upper Failure.
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- Report Percentage Warning Value
Only displayed where the Limit Check Method is Relative.
The relative percentage difference from the Report Target Value below and above which a warning is reported.
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Report Percentage Failure Value
Only displayed where the Limit Check Method is Relative.
The relative percentage difference from the Report Target Value below and above which a failure is reported.
- Spike Adjustment Factor
The spike adjustment factor for the analyte on the specification.
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Spike Adjustment Description
The spike adjustment description for the analyte on the specification.
- Spike Recovery Min Value
The spike recovery minimum value for the analyte on the specification.
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Spike Recovery Min Warning Value
The spike recovery minimum warning value for the analyte on the specification.
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Spike Recovery Max Value
The spike recovery maximum value for the analyte on the specification.
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Spike Recovery Max Warning Value
The spike recovery maximum warning value for the analyte on the specification.
