Conditions for Assessing Detection Limits and Setting Workflow Statuses

A sample scheme analyte's Detection Limit Status is set to Not Tested upon creation or when the result is cleared.

Internal detection limit assessment occurs whenever a sample scheme analyte receives a result, or a result is cleared, and sets sample scheme analyte's Detection Limit Status and Workflow Status.

For any of the following cases, detection limit assessment sets the sample scheme analyte's Detection Limit Status to Not Required:

• The sample does not have a Primary Analytical Type of Unknown or Duplicate, that is, detection limit assessment is only for client samples, client standard samples, client blank samples and Duplicate QC Sample samples,
• The result is not numeric,
• The scheme version analyte's Is QC Active is cleared,
• The sample scheme analyte has no internal detection limits defined.

Note: The sample scheme analyte's Composite QC Status is not impacted by Detection Limit Status.

* Abbreviations: SVA stands for scheme version analyte, SSA stands for sample scheme analyte

Result present?	Primary Analytical Type	Data Type of SSA result	SVA QC Active?	SSA Internal Lower DL defined?	SSA Internal Upper DL defined?	Detection Limit Assessment	SSA Internal Detection Limit Status
No							Not Tested
Yes	Replicate Blank Standard Spike						Not Required
Yes	Unknown Duplicate	Text Boolean Date DateTime Image Document					Not Required
Yes	Unknown Duplicate	Numeric	No				Not Required
Yes	Unknown Duplicate	Numeric	Yes	No	No		Pass
Yes	Unknown Duplicate	Numeric	Yes	Yes	No	SSA's Numeric Final Value >= SSA's Internal Lower DL	Pass
						SSA's Numeric Final Value < SSA's Internal Lower DL	Lower Failure
Yes	Unknown Duplicate	Numeric	Yes	No	Yes	SSA's Numeric Final Value <= SSA's Internal Upper DL	Pass
						SSA's Numeric Final Value > SSA's Internal Upper DL	Upper Failure
Yes	Unknown Duplicate	Numeric	Yes	Yes	m	SSA's Numeric Final Value >= SSA's Internal Lower DL and SSA's Numeric Final Value <= SSA's Internal Upper DL	Pass
						SSA's Numeric Final Value < SSA's Internal Lower DL	Lower Failure
						SSA's Numeric Final Value > SSA's Internal Upper DL	Upper Failure

Note: QC Active is set on the scheme version analyte. Internal Lower DL, Internal Lower DL Critical, Internal Upper DL, Internal Upper DL Critical, Report Lower DL, Report Lower DL Critical, Report Upper DL and Report Upper DL Critical are set on the sample scheme analyte and default to those on the scheme version analyte.

Impact

Criticality of Detection Limit Failures upon Workflow Status

When a result is assessed against internal detection limits to set the sample scheme analyte's Detection Limit Status, this status then affects the setting of the sample scheme analyte's Workflow Status. This can be either Check or Analysed, where a check status means the sample scheme analyte has not completed analysis. The result cannot be released until any failure on this status is addressed.

Abbreviations: SVA stands for scheme version analyte, SSA stands for sample scheme analyte

SSA Internal Detection Limit Status	SSA Internal Lower DL Critical?	SSA Internal Upper DL Critical?	AUTO_ACTIVATE_UPPER_SCHEME application preference checked to configure automatic activation of upper SSA?	Upper SSA for SVA Upper Scheme Code and SVA Upper Analyte Code is registered for the Sample?	SSA Workflow Status	Upper SSA Workflow Status
Not required					Analysed
Passed					Analysed
Lower failure	No				Analysed
Lower failure	Yes				Check
Upper failure		No			Analysed
Upper failure		Yes	Yes	Yes	Analysed	If the upper SSA's Workflow Status is Not Analysed or No Result it is reset to Repeat
Upper failure		Yes	Yes	No	Check
Upper failure		Yes	No, or preference does not exist		Check

Where a SSA's Workflow Status is Check, then the operator must take action to check the result. This can be overcome by Overwriting a Result in a Workbook Session (perhaps the wrong sample portion was used previously so a read of the correct sample portion is required), Requesting a Repeat Analysis in a Workbook Session, Ignoring a Critical Detection Limit Failure in a Workbook Session or Preparing for Check Analysis in a Workbook Session.

A scheme version analyte can be assigned a Lower Template Sample Code and Upper Template Sample Code, such that, if the lower or upper detection limit, respectively, is breached on a sample scheme analyte related to the default scheme version analyte, then the user can trigger the registration of the tests from the particular template sample onto the sample so that check analysis can be performed.

Alternately, a scheme version analyte can be assigned an Upper Scheme and Upper Analyte. The upper scheme and analyte is generally registered for the sample but assigned a Workflow Status of Not Analysed or No Result as there may ultimately be no need to analyse the scheme by this method where the lower scheme's range is suitable based on the result. However, where the upper detection limit is breached on a sample scheme analyte related to the default scheme version analyte and the AUTO_ACTIVATE_UPPER_SCHEME application preference is set, then:

• The linked upper scheme analyte is activated, which means that if the upper sample scheme's Workflow Status is Not Analysed or No Result, then it is set to Not Started to indicate that there are tests outstanding for it.
• The linked upper analyte is activated, which means that if the upper sample scheme analyte's Workflow Status is Not Analysed or No Result, then it is set to Repeat (rather than to Not Started) so that the sample scheme analyte can be located easily since these results need to be determined more quickly to get the report to the client.
• The lower sample scheme analyte's Workflow Status is updated from Check to Analysed to indicate that is completely analysed and that there is nothing further to be done for it.

Refer to Conditions for Auto-activation of Upper Scheme Analytes.

The limitation to using an Upper Scheme and Upper Analyte instead of a Lower Template Sample Code and Upper Template Sample Code is that only one scheme analyte is provided for the check analysis.