Conditions for Assessing Sample Specifications and Setting Specification Statuses

• Conditions for Assessing Sample Specifications and Setting Specification Statuses
  • Possible Status Outcomes of a Specification Assessment
  • Composite QC Status

Specification assessment occurs whenever a sample scheme analyte receives a result, or a result is cleared, and sets the sample scheme analyte specification's Specification Limit Status, that is, for each specification attached to the sample.

Possible Status Outcomes of a Specification Assessment

Note: If a sample scheme analyte receives a result in context of a laboratory batch sample, then the specification assessment uses the specifications attached to the related production sample for the assessment, and sets the specification statuses on the production sample's specifications, since the laboratory batch samples do not inherit specifications from the related production sample.

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

• The sample has a Primary Analytical Type of Unknown, that is, for client, client standard and client blank samples.
• The sample links to one of more sample specifications, which in turn link to a Specification Code,
• The specification contains limits for the scheme version analyte and analysis unit.

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

A sample scheme analyte specification's Specification Status, and a sample scheme analyte's Composite Specification Status, is set to Not Tested upon creation or when the result is cleared.

If a sample has one or more sample specifications defined with a Specification Code and there is a specification limit for the matching sample, scheme, scheme version, analyte and analysis unit, then specification occurs for each specification attached to the sample.

*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	Duplicate Replicate Blank Standard Spike										Not Required
Yes	Unknown	Text, Boolean, Date, DateTime, Image, Document									Not Required
Yes	Unknown	Numeric	No								Not Required
Yes	Unknown	Numeric	Yes	No							Not Required
Yes	Unknown	Numeric	Yes	Yes	No						Not Required
Yes	Unknown	Numeric	Yes	Yes	Yes	No		No			Pass
Yes	Unknown	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	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	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	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	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	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	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	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

• Specification Status Codes for Specification Assessment
• Script Hook Points during Specification Assessment

Composite QC Status

The sample scheme analyte Specification Status, along with the Limit Status, Precision Status and Standard Status, is rolled into sample scheme analyte 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.