Completing and Validating Samples and Jobs

Overview

Quality control (QC) samples are inserted in analytical streams to ensure the accuracy and precision of results.

Once all results on a sample are validated by the relevant supervisor or section head, the sample can proceed to validation, and ultimately the job can be validated. If a certificate report includes a result that has not been validated, the report is considered to be a preliminary report and the result are not shown (instead text is displayed to indicate that the result is not validated as yet), that is, the report cannot be generated as a final report.

Process

This process is to mainly address QC samples, given that any QC failures are clearly indicated in the workbook data grid and do not require that the operator has deeper interpretive skills. It is also the case that any particular operator may only have authorisation to validate a subset of the total analytical suite.

The process of validation is typically used after operators (with limited permissions) have completed workbook result entry. This is the stage at which supervisors with the requisite permissions can move samples and sample scheme analyte results to the next level of validation in the workflow. Supervisors generally have more skills and experience and can identify things that the operators may not identify or be familiar with. This may include the updating of notes on the samples or job, and un-validating samples or the job as necessary, and may include a review of the job audit detail or static data.

Supervisors first of all look for samples, criteria may be job-based, but the primary interest is the sample. Samples may be grouped for validation by workflow status or other criteria. Supervisors look at all the samples in their section that they need to approve because they are signatories for the test.

You can validate sample scheme analyte results and samples in a job. Samples are displayed based on the selected criteria, and your levels of permissions for the sections and schemes that are associated with the sample.

The following actions are used for sample and job validation, and must occur in the following order:

Completing sample schemes that have no analytes.
Searching for samples that require validation.
Ensuring results are validated so that samples are ready for completion and validation.
Validating samples and jobs.
Creating a validation report.
Reviewing job audits.
Reviewing static data audits.

The CCVALN—Job and Sample Validation application is used to release and validate jobs and samples, and also to release and validate results, if required. Various QC actions can be applied to results, for example, ignoring QC failures.

Samples requiring validation are located using a search, often by specifying the job to which the samples belong. These samples are typically ready for validation due to all underlying sample schemes, or at least those in a specific laboratory section, being analysed and completed. Usually, validation is carried out by a user who is different to the user who released the results.

A completed sample scheme means that each underlying sample scheme analyte either has a result which is validated, or is assigned a status that bypasses the fact that the sample was listed not received, or a sample scheme analyte had insufficient sample to perform the test, or was not analysed or marked as having no result.

Job completion is a process used by laboratory managers to ensure that the results for all tests on all samples in the job are completed and ready to undergo validation.

Job validation is a process used by laboratory managers to ensure that the results for all tests performed on all samples in the job make sense and reflect the truth of analysis.

The CCVALN—Job and Sample Validation application is used to locate samples within production, proposal or internal jobs that require validation. Searches should be limited to jobs with a workflow status of analysed as these jobs have completed analysis and therefore contain samples requiring validation.

Restrictions on Completing and Validating Registered Samples and Jobs

It is not possible, under any circumstance, or by any level of user, to validate a sample or job if there is underlying failure, or missing data without firstly taking one, or more, recognised actions to bypass these failures. Therefore:

A production, proposal or internal job cannot be validation if its samples are not validated.
A production, proposal or internal sample cannot be validated if its sample schemes are not validated.
Prior to sample and job validation, sample schemes that have no analytes can be marked as completed.
If results are not validated at point of analysis, they can be validated in this process. For sample scheme analyte results it may be necessary to ignore a DL failure on results, request a repeat of analysis for a result, ignore a composite QC failure on results, and release results before results are validated.

A production, proposal, or internal sample scheme cannot be validated if any related sample scheme analytes are included in laboratory batch jobs and results are validated within the context of the laboratory batch jobs, but the laboratory batch job itself is not validated. That is, where a production, proposal or internal sample scheme analyte is included in a laboratory batch job, then if the results are validated within the context of the production, proposal or internal job, the cascade engine flows the validation up the production, proposal or internal job tree. However, if the results are validated within the context of the laboratory batch job, the cascade engine flows the validation up the laboratory batch job tree and stops there until the laboratory batch job is validated, and does not mark the related production, proposal or internal sample scheme as validated until the laboratory batch job is validated.

Laboratory batch jobs are used to combine samples from multiple production, proposal or internal jobs, to gain efficiency and cost-benefits in analytical processes for the schemes within the laboratory batch job.

Where sample scheme analytes have results entered and validated in context of:

A laboratory batch job, then:
- The related sample within that laboratory batch job needs to be validated (either manually or with automatic validation), and then the laboratory batch job needs to be validated (either manually or with automatic validation), in order for the sample scheme within the production, proposal or internal sample scheme to be considered completed and validated.
- The cascade engine first cascades up the laboratory batch job tree, and then up the production, proposal or internal job tree. Only after the laboratory batch job attains a validated state is it possible for the sample scheme in the production, proposal or internal job to attain a validated state.
  
  For example, if all sample schemes of a sample were included in laboratory batch jobs, and all results were entered in context of those laboratory batch jobs, then each laboratory batch job needs to attain a validated state before the sample schemes within the production, proposal or internal job can attain a validated state—they will, at most, have a workflow status of released.
  
  The system can be configured to apply automatic validation of samples in laboratory batch jobs once all related sample schemes have attained a validation state, and/or to apply automatic validation of laboratory batch jobs once all related samples have attained a validation state. Otherwise these samples and jobs need to be validated manually.
A production, proposal or internal job, then:
- The sample scheme attains a validation state when all of its sample scheme analytes are validated.
- The cascade engine only cascades up the production, proposal or internal job tree, and any related laboratory batch job trees are left unattended as the results were not entered into them.

Therefore, where a sample has one of its sample schemes included in a laboratory batch job, the context in which results are entered has bearing upon the pathway undertaken by the cascade engine to cascade validation.

Manually Completing and Validating Registered Samples

Getting a production, proposal or internal sample to a validated state requires two processes:

Sample completion—This process is used to indicate that the results for all tests on the sample are completed and ready to undergo validation.
Sample validation—This process is used to ensure that the results for all tests performed on the sample make sense and reflect the truth of analysis.

Although these are essentially two different processes, the CCVALN—Job and Sample Validation application attempts to complete and validate samples in a one-step, instead of in a two-step, process. It may not be apparent to the user that it is in-fact a two-step process, however, security controls are in place on each process. For example, where a user can complete but not validate samples, then an attempt at sample validation only allows the sample to be marked completed but not validated.

Where a sample has a Workflow Status of Released, Listed Not Received, Insufficient Sample, Not Analysed or No Result, and all related sample schemes have a Workflow Status of Completed, when a user attempts the one-step validation process, then the system attempts the manual sample completion step. Where this is successful and automatic sample validation is not configured, then the system attempts the manual sample validation step.

Where a sample has a Workflow Status of Completed, Listed Not Received, Insufficient Sample, Not Analysed or No Result, and all related sample schemes have their Validated Date stamped, when a user attempts the one-step validation process, then the system attempts the manual validation step.

Manual sample completion step:

When an attempt is made to complete a registered sample, where the registered sample's Workflow Status is Released, Listed Not Received, Insufficient Sample, Not Analysed or No Result, and the COMPLETE_SAMPLES_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the registered sample's Workflow Status sets from Released to Completed (other workflow statuses do not change), but Validated Date remains unstamped and Validated By remains empty. Subsequent to sample completion, where the AUTO_COMPLETE_SAMPLES application preference is checked, then the registered sample is validated automatically, otherwise the sample requires manual validation.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the registered sample's Workflow Status remains unchanged.
When an attempt is made to complete a laboratory batch sample, where the laboratory batch sample's Workflow Status is Released, Listed Not Received, Insufficient Sample, Not Analysed or No Result, and the COMPLETE_BATCH_SAMPLES_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the laboratory batch sample's Workflow Status sets from Released to Completed (other workflow statuses do not change), but Validated Date remains unstamped and Validated By remains empt.. Subsequent to sample completion, where the AUTO_COMPLETE_LAB_BATCH_SAMPLES application preference is checked, then the laboratory batch sample is validated automatically, otherwise the sample requires manual validation.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the laboratory batch sample's Workflow Status remains unchanged.

Manual sample validation step:

When an attempt is made to validate a registered sample, where the registered sample's Workflow Status of Completed, Listed Not Received, Insufficient Sample, Not Analysed or No Result, and all related sample schemes have their Validated Date stamped, and the VALIDATE_SAMPLES_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the registered sample's Workflow Status remains unchanged, but Validated Date is stamped and Validated By is set to the current user.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the registered sample's Workflow Status remains unchanged.
When an attempt is made to validate a laboratory batch sample, where the registered sample's Workflow Status of Completed, Listed Not Received, Insufficient Sample, Not Analysed or No Result, and all related sample schemes have their Validated Date stamped, and the VALIDATE_BATCH_SAMPLES_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the laboratory batch sample's Workflow Status remains unchanged, but Validated Date is stamped and Validated By is set to the current user.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the laboratory batch sample's Workflow Status remains unchanged.

Samples can also be validated automatically based upon product assessment passing critical specification limits. Refer to Configuring Automatic Result Validation for a Product.

Actions on Samples Available from Validation

For samples located for validation, you can:

Validate or unvalidate samples
Open sample details
Open sample notes
Open the worklist dialog
Open sample audit.

Manually Completing and Validating Registered Jobs

Getting a production, proposal or internal job to a validated state requires two processes:

Job completion—This process is used to indicate that the results for all samples in the job are completed and ready to undergo validation.
Job validation—This process is used to ensure that the results for all samples in the job make sense and reflect the truth of analysis.

Although these are essentially two different processes, the CCVALN—Job and Sample Validation application attempts to complete and validate jobs in a one-step, instead of in a two-step, process. It may not be apparent to the user that it is in-fact a two-step process, however, security controls are in place on each process. For example, where a user can complete but not validate jobs, then an attempt at job validation only allows the job to be marked completed but not validated.

Where a job has a Workflow Status of Released, and all related samples have a Workflow Status of Completed, Listed Not Received, Insufficient Sample, Not Analysed or No Result, when a user attempts the one-step validation process, then the system attempts the manual job completion step. Where this is successful and automatic job validation is not configured, then the system attempts the manual job validation step.

Where a job has a Workflow Status of Completed and all related samples have their Validated Date stamped, when a user attempts the one-step validation process, then the system attempts the manual validation step.

Manual job completion step:

When an attempt is made to complete a registered job, where the registered job's Workflow Status is Released, and the COMPLETE_JOBS_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the registered job's Workflow Status sets to Completed, but Validated Date remains unstamped and Validated By remains empty. Subsequent to job completion, where the AUTO_COMPLETE_JOBS application preference is checked, then the registered job is validated automatically, otherwise the job requires manual validation.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the registered job's Workflow Status remains unchanged.
When an attempt is made to complete a laboratory batch job, where the laboratory batch job's Workflow Status is Released, and the COMPLETE_BATCH_JOBS_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the laboratory batch job's Workflow Status sets to Completed, but Validated Date remains unstamped and Validated By remains empty. Subsequent to job completion, where the AUTO_COMPLETE_LAB_BATCH_JOBS application preference is checked, then the laboratory batch job is validated automatically, otherwise the job requires manual validation.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the laboratory batch job's Workflow Status remains unchanged.

Manual job validation step:

When an attempt is made to validate a registered job, where the registered job's Workflow Status of Completed, and all related samples have their Validated Date stamped, and the VALIDATE_JOBS_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the registered job's Workflow Status remains unchanged, but Validated Date is stamped and Validated By is set to the current user.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the registered job's Workflow Status remains unchanged.
When an attempt is made to validate a laboratory batch job, where the registered job's Workflow Status of Completed, and all related samples have their Validated Date stamped, and the VALIDATE_BATCH_JOBS_USERGROUP application preference is:
- Not defined, or is defined and the user is a member of the user group, then the action proceeds in which the laboratory batch job's Workflow Status remains unchanged, but Validated Date is stamped and Validated By is set to the current user.
- Defined, and the user is not a member of the user group, then the action does not proceed, such that, the laboratory batch job's Workflow Status remains unchanged.

Refer to Creating a Validation Report to create a validation report, add a signatory to a job, or export samples to a validation grid report.

Actions on Jobs Available from Validation

For jobs related to samples located for validation, you can:

Validate or unvalidate jobs
Open job details
Update job notes
Open workbook
Open job audit.