Conditions for Assessing Scheme or Surrogate Limits and Setting QC Statuses

• Conditions for Assessing Scheme or Surrogate Limits and Setting QC Statuses
  • Possible Status Outcomes of a Scheme Limit Assessment
  • Possible Status Outcomes of a Surrogate Limit Assessment
  • Calculation of Recovery as a Percentage following a Surrogate Limit Assessment
  • Composite QC Status

Scheme limit or surrogate limit assessment occurs whenever a sample scheme analyte receives a result, or a result is cleared, and sets the sample scheme analyte's Scheme Limit Status.

Possible Status Outcomes of a Scheme Limit Assessment

Primary specification assessment, resulting in a sample scheme analyte's Scheme Limit Status being set to something other than Not Required, occurs where:

• The sample has a Primary Analytical Type of Unknown, Duplicate or Replicate, that is, for client samples, client standard samples, client blank samples, duplicate samples or replicate samples,
• The scheme version analyte's Is QC Active is selected,
• The sample scheme links to a Scheme Limit Specification Code, or has surrogate limits,
• The specification contains limits for the scheme version analyte and analysis unit.

In all other cases, specification assessment sets the sample scheme analyte's Scheme Limit Status to Not Required.

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

If a sample scheme has a Scheme Limit Specification Code defined and there is a specification limit for the matching sample, scheme, scheme version, analyte and analysis unit, then scheme limit assessment occurs instead of surrogate limit assessment. This provides for a more powerful or complex assessment than surrogate assessment.

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

Result Present?	Primary Analytical Type	Data Type of SSA result	SVA QC Active?	SS Scheme Limit Specification defined?	Matching SpecSVA exists for the SS Specification (match on Scheme Code, Analyte Code, Internal Unit Code)	SpecSVA Internal Min Value defined?	SpecSVA Internal Min Value Inclusive?	SpecSVA Internal Max Value defined?	SpecSVA Internal Max Value inclusive?	Scheme Limit Assessment	SSA Scheme Limit Status
No											Not Tested
Yes	Blank Standard Spike										Not Required
Yes	Unknown Duplicate Replicate	Text, Boolean, Date, DateTime, Image, Document									Not Required
Yes	Unknown Duplicate Replicate	Numeric	No								Not Required
Yes	Unknown Duplicate Replicate	Numeric	Yes	No						Attempt surrogate limit assessment instead
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	No					Attempt surrogate limit assessment instead
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	No		No			Pass
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	Yes	No	No		SSA's Numeric Final Value > SpecSVA's Internal Min Value	Pass
										SSA's Numeric Final Value <= SpecSVA's Internal Min Value	Lower Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	Yes	Yes	No		SSA's Numeric Final Value >= SpecSVA's Internal Min Value	Pass
										SSA's Numeric Final Value < SpecSVA's Internal Min Value	Lower Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	No		Yes	No	SSA's Numeric Final Value < SpecSVA's Internal Max Value	Pass
										SSA's Numeric Final Value >= SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	No		Yes	Yes	SSA's Numeric Final Value <= SpecSVA's Internal Max Value	Pass
										SSA's Numeric Final Value > SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	Yes	No	Yes	No	SSA's Numeric Final Value > SpecSVA's Internal Min Value and SSA's Numeric Final Value < SpecSVA's Internal Max Value	Pass
										SSA's Numeric Final Value <= SpecSVA's Internal Min Value	Lower Failure
										SSA's Numeric Final Value >= SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	Yes	No	Yes	Yes	SSA's Numeric Final Value > SpecSVA's Internal Min Value and SSA's Numeric Final Value <= SpecSVA's Internal Max Value	Pass
										SSA's Numeric Final Value <= SpecSVA's Internal Min Value	Lower Failure
										SSA's Numeric Final Value > SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	Yes	Yes	Yes	No	SSA's Numeric Final Value >= SpecSVA's Internal Min Value and SSA's Numeric Final Value < SpecSVA's Internal Max Value	Pass
										SSA's Numeric Final Value < SpecSVA's Internal Min Value	Lower Failure
										SSA's Numeric Final Value >= SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Yes	Yes	Yes	Yes	Yes	Yes	SSA's Numeric Final Value >= SpecSVA's Internal Min Value and SSA's Numeric Final Value <= SpecSVA's Internal Max Value	Pass
										SSA's Numeric Final Value < SpecSVA's Internal Min Value	Lower Failure
										SSA's Numeric Final Value > SpecSVA's Internal Max Value	Upper Failure

• Scheme Limit Status Codes for Scheme or Surrogate Limit Assessment
• Script Hook Points during Scheme Limit Assessment

Possible Status Outcomes of a Surrogate Limit Assessment

If a sample scheme does not have a Scheme Limit Specification Code defined, or it is defined but there is no specification limit for the matching sample scheme's scheme, scheme version, analyte and analysis unit, then surrogate limit assessment occurs instead of scheme limit assessment.

Surrogate limit assessment occurs only when the scheme version analyte has Surrogate QC Type, Surrogate Target Value, Surrogate Recovery Lower Limit and/or Surrogate Recovery Upper Upper defined, according to the scheme version analyte's Is Surrogate Result Critical setting.

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

Result present?	Primary Analytical Type	Data Type of result	SVA QC Active?	SVA Is Surrogate Result Critical?	SVA Surrogate Recovery Lower Limit defined?	SVA Surrogate Recovery Upper Limit defined?	Surrogate Limit Assessment	SSA Scheme Limit Status
No								Not Tested
Yes	Blank Standard Blank Spike							Not Required
Yes	Unknown Duplicate Replicate	Text, Boolean, Date, DateTime, Image, Document						Not Required
Yes	Unknown Duplicate Replicate	Numeric	No					Not Required
Yes	Unknown Duplicate Replicate	Numeric	Yes	Lower Limit Critical	No			Not Required
Yes	Unknown Duplicate Replicate	Numeric	Yes	Lower Lit Critical	Yes		SSA's Numeric Final Value >= SVA's Surrogate Rec Lower Limit	Pass
							SSA's Numeric Final Value < SVA's Surrogate Rec Lower Limit	Lower Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Upper Limit Critical	No			Not Required
Yes	Unknown Duplicate Replicate	Numeric	Yes	Upper Limit Critical	Yes		SSA's Numeric Final Value <= SVA's Surrogate Rec Upper Limit	Pass
							SSA's Numeric Final Value > SVA's Surrogate Rec Upper Limit	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Lower and Upper Limit Critical	No	No	Not Required	Not Required
Yes	Unknown Duplicate Replicate	Numeric	Yes	Lower and Upper Limit Critical	No	Yes	SSA's Numeric Final Value <= SVA's Surrogate Rec Upper Limit	Pass
							SSA's Numeric Final Value > SVA's Surrogate Rec Upper Limit	Upper Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Lower and Upper Limit Critical	Yes	No	SSA's Numeric Final Value >= SVA's Surrogate Rec Lower Limit	Pass
							SSA's Numeric Final Value < SVA's Surrogate Rec Upper Limit	Lower Failure
Yes	Unknown Duplicate Replicate	Numeric	Yes	Lower and Upper Limit Critical	Yes	Yes	SSA's Numeric Final Value <= SVA's Surrogate Rec Upper Limit and SSA's Numeric Final Value >= SVA's Surrogate Rec Upper Limit	Pass
							SSA's Numeric Final Value < SVA's Surrogate Rec Upper Limit	Lower Failure
							SSA's Numeric Final Value > SVA's Surrogate Rec Upper Limit	Upper Failure

• Scheme Limit Status Codes for Scheme or Surrogate Limit Assessment
• Script Hook Points during Scheme Limit Assessment

Calculation of Recovery as a Percentage following a Surrogate Limit Assessment

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

If the SSA's Standard Status is something other than Not Tested and Not Required, then calculate the SSA's Recovery (as a percentage) following a surrogate limit assessment.

If the SVA's Surrogate Target Value <> 0, then the SSA's Recovery = the SSA's Final Numeric Value / the SVA's Surrogate Target Value * 100

Composite QC Status

The sample scheme analyte's Limit Status, along with the Standard Status, Precision Status and Specification Status, is rolled into the sample scheme analyte's Composite QC Status. When the Composite QC Status is Warning or Failure, the operator is notified by the workbook cell being highlighted yellow or red, respectively. A sample scheme analyte that has a Composite QC Status of Failure cannot be validated to have the sample scheme analyte's Workflow Status set to Completed.

If a sample scheme analyte's Composite QC Status of Failure is subsequently ignored by the operator, the Composite QC Status is changed to Ignore Failure.