Conditions for Assessing Accuracy and Setting QC Statuses

Accuracy assessment occurs whenever a sample scheme analyte receives a result, or a result is cleared, and sets the sample scheme analyte's Standard Status.

Possible Status Outcomes of an Accuracy Assessment

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

The sample has a Primary Analytical Type or Secondary Analytical Type of Blank, Standard or Spike, that is, a client blank sample, client standard sample, blank sample, blank duplicate sample, blank replicate sample, standard sample, standard duplicate sample, standard replicate sample, spike sample, spike duplicate sample and spike replicate sample,
The scheme version analyte's Is QC Active is selected,
The sample links to a Standard Code and Standard Lot Code,
The standard lot links to a Specification Code,
The specification contains limits for the scheme version analyte and analysis unit.

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

Note: Where a sample that has a Primary Analytical Type of Blank, Standard or Spike AND also a Secondary Analytical Type of Duplicate or Replicate, then the sample undergoes both accuracy assessment and precision assessment. If the assessment outcomes are to be written to QC history, two records are written—one for the accuracy assessment, and one for the precision assessment.

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

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

Result present?	Primary Analytical Type and Secondary Analytical Type	Spike Original Sample result present?	Data Type of result/s	SVA QC Active?	Sample's Standard Lot defined?	Standard Lot's Specification defined?	Matching SpecSVA exists for the Standard Lot's Specification (match on Scheme Code, Analyte Code, Internal Unit Code)	Internal Min Value defined?	Internal Min Value Inclusive?	Internal Max Value defined?	Internal Max Value inclusive?	Accuracy Assessment	SSA Standard Status
No													Not Tested
Yes	Unknown-N/A Duplicate-N/A Replicate-N/A												Not Required
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Text, Boolean, Date, DateTime, Image, Document										Not Required
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	No									Not Required
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	No								Not Required
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	No							Not Required
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	No						Not Required
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	No		No			Pass
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	No		Yes	No	SSA's Numeric Final Value < SpecSVA's Internal Max Value	Pass
Yes		n/a	Numeric	Yes	Yes	Yes	Yes	No		Yes	No	SSA's Numeric Final Value >= SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	No		Yes	Yes	SSA's Numeric Final Value <= SpecSVA's Internal Max Value	Pass
Yes		n/a	Numeric	Yes	Yes	Yes	Yes	No		Yes	Yes	SSA's Numeric Final Value > SpecSVA's Internal Max Value	Upper Failure
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	Yes	No	No		SSA's Numeric Final Value > SpecSVA's Internal Min Value	Pass
Yes		n/a	Numeric	Yes	Yes	Yes	Yes	Yes	No	No		SSA's Numeric Final Value <= SpecSVA's Internal Min Value	Lower Failure
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	Yes	Yes	No		SSA's Numeric Final Value >= SpecSVA's Internal Min Value	Pass
Yes		n/a	Numeric	Yes	Yes	Yes	Yes	Yes	Yes	No		SSA's Numeric Final Value < SpecSVA's Internal Min Value	Lower Failure
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	Yes	No	Yes	No	SSA's Numeric Final Value > SpecSVA's Internal Min Value and 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-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes	SSA's Numeric Final Value > SpecSVA's Internal Min Value and Numeric Final Value <= SpecSVA's Internal Max Value	Pass
												SSA's Numeric Final Value <= SpecSVA.Internal Min Value	Lower Failure
												SSA's Numeric Final Value > SpecSVA.Internal Max Value	Upper Failure
Yes	Unknown-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	SSA's Numeric Final Value >= SpecSVA's Internal Min Value and 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-Blank Unknown-Standard Blank-N/A Blank-Duplicate Blank-Replicate Standard-N/A Standard-Duplicate Standard-Replicate	n/a	Numeric	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	SSA's Numeric Final Value >= SpecSVA's Internal Min Value and 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	Spike-N/A Spike-Duplicate Spike-Replicate	No											Not Tested
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Either result is Text, Boolean, Date, DateTime, Image, Document										Not Required
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	No									Not Required
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	No								Not Required
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	No							Not Required
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	No						Not Required
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	No		No			Pass
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	No		Yes	No	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) < SpecSVA's Internal Max Value	Pass
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	No		Yes	No	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) >= SpecSVA's Internal Max Value	Upper Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	No		Yes	Yes	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) <= SpecSVA's Internal Max Value	Pass
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	No		Yes	Yes	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) > SpecSVA's Internal Max Value	Upper Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	No	No		SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) > SpecSVA's Internal Min Value	Pass
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	No	No		SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) <= SpecSVA's Internal Min Value	Lower Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	Yes	No		SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) >= SpecSVA's Internal Min Value	Pass
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	Yes	No		SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) < SpecSVA's Internal Min Value	Lower Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	No	Yes	No	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) > SpecSVA's Internal Min Value and (Numeric Final Value—SpikeOrig Numeric Final Value ) < SpecSVA's Internal Max Value	Pass
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) <= SpecSVA's Internal Min Value	Lower Failure
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) >= SpecSVA's Internal Max Value	Upper Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	No	Yes	Yes	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) > SpecSVA's Internal Min Value and (Numeric Final Value—SpikeOrig Numeric Final Value ) <= SpecSVA's Internal Max Value	Pass
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) <= SpecSVA's Internal Min Value	Lower Failure
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) > SpecSVA's Internal Max Value	Upper Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	Yes	Yes	No	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) >= SpecSVA's Internal Min Value and (Numeric Final Value—SpikeOrig Numeric Final Value ) < SpecSVA's Internal Max Value	Pass
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) < SpecSVA's Internal Min Value	Lower Failure
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) >= SpecSVA's Internal Max Value	Upper Failure
Yes	Spike-N/A Spike-Duplicate Spike-Replicate	Yes	Both Numeric	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) >= SpecSVA's Internal Min Value and (Numeric Final Value—SpikeOrig Numeric Final Value ) <= SpecSVA's Internal Max Value	Pass
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) < SpecSVA's Internal Min Value	Lower Failure
												SSA's (Numeric Final Value—SpikeOrig Numeric Final Value ) > SpecSVA's Internal Max Value	Upper Failure

Calculation of PD (%Difference from the Standard's Expected Value) following an Accuracy Assessment

Abbreviations: SpecSVA stands for specification scheme version analyte, SSA stands for sample scheme analyte

If the SSA's Standard Status is something other than Not Tested or Not Required, then calculate SSA PD (percentage difference).

Locate the Sample > Standard Lot > Specification > SpecSVA.

If the SpecSVA's Expected Value is undefined or zero, then SSA PD = 0; exit.

If the sample's Primary Analytical Type or Secondary Analytical Type is Blank or Standard, then:

If the USE_STD_TARGET_FOR_PERCENT_DIFFERENCE application preference is not defined, or is defined and selected, when calculating SSA PD, then Xbar = Abs (SpecSVA Expected Value)

If the USE_STD_TARGET_FOR_PERCENT_DIFFERENCE application preference is defined and is cleared, when calculating SSA PD, then Xbar = Abs (SpecSVA Expected Value + SSA Final Numeric Value) / 2

If Xbar = 0 then SSA PD = 0; exit

SSA's PD = Abs (SpecSVA Expected Value—SSA Final Numeric Value) * 100 / Xbar

If the sample's Primary Analytical Type is Spike, then:

If the USE_STD_TARGET_FOR_PERCENT_DIFFERENCE application preference is not defined, or is defined and selected, when calculating SSA PD, then Xbar = Abs (SpecSVA Expected Value)

If the USE_STD_TARGET_FOR_PERCENT_DIFFERENCE application preference is defined and is cleared, when calculating SSA PD, then Xbar = Abs (SpecSVA Expected Value + (SSA Final Numeric Value—Spike Original SSA Final Numeric Value)) / 2

If Xbar = 0 then SSA PD = 0; exit

SSA's PD = Abs (SpecSVA Expected Value—(SSA Final Numeric Value—Spike Original SSA Final Numeric Value)) * 100 / Xbar

Calculation of Recovery (%Recovery from the Standard's Expected Value) following an Accuracy Assessment

Abbreviations: SpecSVA stands for specification scheme version analyte, SSA stands for sample scheme analyte

If the SSA's Standard Status is something other than Not Tested or Not Required, then calculate the SSA's Recovery (Percentage Recovery).

Locate the Sample > Standard Lot > Specification > SpecSVA.

If SpecSVA's Expected Value is undefined or zero, then the SSA's PD = 0; exit.

If the sample's Primary Analytical Type or Secondary Analytical Type is Standard or Blank, then:

If the SpecSSA's Internal Target Value is undefined or 0, then the SSA's Recovery is left empty

SSA's Recovery = SSA's Final Numeric Value / SpecSVA's Internal Target Value * 100

If the sample's Primary Analytical Type is Spike, then:

If the SpecSVA's Internal Target Value is undefined or 0, then the SSA's Recovery is left empty

SSA's Recovery = (SSA's Final Numeric Value—Spike Original SSA's Final Numeric Value) / SpecSVA's Internal Target Value) * 100

Rounding of PD and Recovery

After the PD and Recovery are calculated, then they are rounded to 5 decimal places. This also applies when forcing reassessment of results either manually or via a workbook onLoad script.

If PD and/or Recovery are changed in a workbook session, then only the rounded values are compared. Values with zeroes after the decimal places are managed, for example, 0.1100 and 0.11 are treated as the same value, at 5 decimal places.

Since historical calculations of these properties on sample scheme analytes are unrounded to 5 decimal places, if the results are reassessed in workbook, then those cells containing a rounded PD and Recovery value are flagged as dirty and saved upon submit and the related QC History observations are updated, and created where they do not yet exist.

Composite QC Status

The sample scheme analyte Standard Status, along with the Limit Status, Precision Status and Specification 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. Where the result of the accuracy assessment is saved to QC history, the QC Status of the QC history precision record is changed from Lower Failure to Ignore Lower Failure, or from Upper Failure to Ignore Upper Failure.