MV Overview and Details

MV Overview and Details

MV Overview and Details

MV’s can refer to Method Validations or Method Verifications. MVs are a systematic process of evaluating the performance of medical tests.

Overview

Cualia.io provides an online platform for laboratory professionals to produce robust MV experimentation and documentation to help your lab perform MVs cohesively.

  • Analytical Performance: Evaluating parameters such as precision, accuracy, sensitivity, specificity, and reproducibility.
  • Clinical Performance: Assessing how well the analyzer performs in a clinical setting, including its impact on patient outcomes.
  • Risk Management: Identifying potential risks associated with the analyzer and implementing measures to mitigate them.
  • Compliance with Standards: Ensuring the analyzer adheres to relevant international standards and regulations, such as ISO 15189 (Medical laboratories – Requirements for quality and competence) and ISO 13485 (Medical devices – Quality management systems).

Lab Juice

Validation vs Verification

Most modern medical labs purchase commercially available analyzers from manufacturers. For an analyzer to be commercially available it must have already gone through a strict validation process that was approved by an authoritative regulator such as the FDA or CE.

It is then the laboratory’s responsibility to verify the performance claims from the validation results.

Validation

Validation is the process conducted by manufacturers to establish that a test method or analyzer meets the required performance criteria and is suitable for its intended use.

This comprehensive assessment occurs before the product enters the commercial market and involves extensive testing to document accuracy, precision, specificity, sensitivity, and other key performance characteristics.

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Validated tests that have undergone changes to their procedure or reagents are considered Laboratory Developed Tests (LDTs) and must be validated.

Verification

Verification is performed by laboratories to confirm that the performance characteristics stated by the manufacturer are achievable under their specific operating conditions. When a laboratory implements a new test or analyzer, it is their responsibility to verify that it performs according to the manufacturer’s claims, as detailed in the insert.

This step ensures that the test produces consistent and reliable results in the lab’s unique environment.

Verification is essential for maintaining the integrity of test results and ensuring that they meet the required standards for accurate clinical decision-making.

Key Aspects of Verification

  1. Confirming Manufacturer's Claims: Laboratories must verify that the test or analyzer performs according to the specifications outlined in the manufacturer insert. This includes checking parameters like accuracy, precision, and sensitivity.
  1. Reproducibility: Verification ensures that the test or analyzer produces consistent and reproducible results within the laboratory's environment and conditions.
  1. Specific Conditions: The laboratory must verify performance under their specific conditions, such as different operators, equipment, and environmental factors, to ensure reliable results.
  1. Documentation: The results of the verification process must be thoroughly documented. This documentation should show that the laboratory has confirmed the manufacturer's performance claims.

Definitions

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**Cualia Support Docs Definitions (Public)**

Name
Definition
Result(s)

A value or determination collected by measurement or calculation.

Eligible (Sample and Results)

Samples that provide the necessary information for statistical calculations to be performed. Usually this is possessing both an actual and expected result.

Lab Contact

Lab Contact is the primary contact method of reaching a laboratory. This can be an email, phone number or name.

Report

An MV report documents analyzer details, tests, and results for submission to accreditation bodies.

Regulator

An organization or government agency responsible for offering accreditation or qualifications for medical laboratory testing.

Analyst

The name of the Cualia member that performed the analytical testing

Method Verification

A systematic process to evaluate whether the performance of a medical Test meets quality goals set by a validation. Performance evaluations may usually be found in a manufacturer insert.

⚪️ Drafting

An Approval Status for an MV where work is in progress. In this state the MV can be edited.

Methodology

The principle mechanism or technology utilized by a system such as Radio Immunoassay or RT-PCR.

Manufacturer Claim

A performance metric for a test determined by the Manufacturer through Validation

Disagreement

When two values, based testing requirements and Error Allowance are outside of acceptable agreement.

MV

A broad term that can be used synonymously with Performance Evaluation, Method Validation and/or Method Verification.

Labs

A specific location within the organization where laboratory tests and analyses are conducted.

Approval Status

The status of an Experiment or MV. Either Drafting, Under Review or Approved.

Test Systems

A Testing System is a product, model, system or a developed process/method used in the medical laboratory setting for performing analysis of clinical samples. This can represent a system offered a Manufacturer or an LDT

🟢 Approved

An Approval Status for an MV that has been approved by the lab and ready for audit by a regulatory assessor.

Method Validation

A systematic process to evaluate whether the performance of a medical Test meets quality goals to be used for medical testing.

Department

A specialized division within a lab that focuses on particular types of tests or medical disciplines.

Organization

The top-level entity representing the overall institution, such as a hospital, clinic, or laboratory network.

Analyzer

An instrument/kit from a Testing System that is used to perform Tests

Result Type

The type of result, either Qualitative, Semi-Quantitative, or Quantitative that Test Result can offer.

Manufacturer

The name of the Testing System manufacturer that produced the instrument.

Descriptive Statisitcs

Statistically generated summary data used to represent the collection

Manufacturer Insert

A document from the Manufacturer of a Test providing details on Manufacturer Claims, Procedures, warnings and any other considerations for testing.

Laboratory Developed Test (LDT)

A method developed by the laboratory or a regulator approved/validated method that has been modified.

Study

A set of experiments performed to validate/verify a test procedure.

Test

A Test is a process used to determine the presence or concentration of a substrate.

Agreement

Whether two values, usually the actual and reference values acceptably agreeable, based on testing requirements and/or Error Allowance.

🟡 Under Review

An Approval Status for an MV where the work is prepared and ready for evaluation by another laboratory member.

Material

A material, such as a reagent, control, or calibrator used to execute a procedure or process

MV Details

Filename

The Filename allows for identification of the MV when there are multiple MVs for a single analyzer. It is recommended to use descriptive filenames to stay organized.

Evaluator

The Evaluator if the primary person in charge of the MV. On starting an MV the evaluator is the person that created document. Anyone in the organization may be selected to be the evaluator.

Approval Status

The Approval Status for an MV designates what stage of work it has reached. Sometimes an MV can take months to reach maturity due to sample requirements for experiments. It is also important for external assessment as auditors should not be viewing drafted work that can be changed and is not final.

Changing an Approval Status can be done on an MV left side navigation and selecting the new approval state. On selection, the evaluator is required to enter in a short message about the change. When set to “Under Review” the verification will show up on the on the Cualia dashboard.

The change of approval state will be recorded with the date and evaluator. This cannot be deleted to ensure proper laboratory protocol and traceability.

Organization Name

An Organization represents a collective entity such as a company, institution, or group that oversees multiple laboratories. It acts as the top-level structure within the app, under which labs and their respective departments are organized.

Organizations in the Cualia App are the primary account holders, managing access permissions, resources, and data across all underlying labs.

Lab Name

A Lab within an organization represents a specific physical location. It is is then made up of various departments that specialize in different aspects of the lab's overall focus. Labs manage their projects, team members, and equipment, ensuring a collaborative and efficient research environment.

Department Name

Departments are specialty areas or subdivisions of medical testing. Each department is responsible for its objectives, tasks, and personnel, contributing to the lab's collective goals under the broader organization's mission.

Permissions for Cualia members are designated by department and may be adjusted in Settings.

Lab Contact

Lab Contact is the primary contact method of reaching a laboratory. This can be an email, phone number or name.

Analyzer Name

The Analyzer Name, usually the model's name or test system provided by the manufacturer. It is important to use a name that identifies the model correctly to maintain the recognizability of the analyzer.

Analyzer Display Name

The Analyzer Display Name is a shorter human readable designation given to an analyzer used to distinguish it in common workplace discourse (eg Blue CBC). Oftentimes it can be helpful in a laboratory to give more casual identifiers to laboratory equipment instead of longer model numbers and serial identifiers.

The display name is used throughout Cualia to identify analyzers. It is a required field with a max length of 12 characters.

Analyzer Identifier

The Analyzer Identifier is a unique identifier for the analyzer. Usually the Serial Number provided by the manufacturer.

Analyzer Manufacturer Name

The Manufacturer Name field allows for identification of the manufacturer. Most Analyzers used in the medical setting today are commercially available by authorization of an authoritative agency and pre-validated by the manufacturer.

Selecting the field will open a set of options from the Cualia Library however you may enter another if it is not available. This field is required for your analyzer.

Manufacturers are specialized companies that design, develop, and produce sophisticated diagnostic instruments used in clinical laboratories. These manufacturers play a crucial role in the healthcare industry by providing high-quality analyzers that facilitate accurate and efficient testing of various biological samples.

If the analyzer was developed in house we suggest using the name of your organization or to use Laboratory Developed Test (LDT)

Analyzer Methodology(s)

Methodologies refer to the specific techniques or processes used by the analyzer to perform tests. The tag input feature offers suggestions based on commonly used methodologies, such as immunoassay, chromatography, and flow cytometry. This helps ensure consistency and accuracy in documenting the analyzer's capabilities by allowing quick selection of standardized methods.

For comprehensive documentation, custom methodologies can be input by typing them into the tag input field and pressing return. This is an optional field and adds clarity to the organization’s laboratory processes.

Analyzer Description

The Analyzer Description field is a text field where detailed information about the analyzer can be entered. This optional field, with a maximum limit of 1000 characters, allows for a comprehensive description that can include the analyzer’s key features, functionalities, intended applications, and any unique capabilities.

Subscription Plans

Free Plan Limited to 3 tests per MV (all experiments). All members have edit access to the MV. Once an MV is approved it cannot return to a different status.
Core Lab Plan Unlimited tests and experiments.
Organization Plan - Coming Soon - Unlimited tests and experiments. Removal of past approval statuses. Fine tuned report headers and footers.

Start an MV

  1. To Start an MV, navigate to the Analyzer that requires MV
  2. Select the Verifications tab
  3. Click the + New Verification button and you will be redirected to your new MV in just a few seconds.

The new MV will include all the current information for your organization, analyzer and tests.

Navigating the MV

The MV has 3 major sections: Experiment Design, Tests & Experiments, and Report with navigation available on the left side.

The left side MV Navigation shows the filename, information about the analyzer, approval status, and a progress bar on the bottom left corner.

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Experiment Design

The Setting section allows for managing the experimental design of the overall MV. This includes the MV section explained above.

Other details include selecting the Tests from the analyzer which will be part of the MV and the MV experiments that will be performed. The materials section allows for adding any items used for the MV such as calibrators, reagents and controls.

Tests and Experiments

This section in the MV is where the work happens. Within this area there is easy navigation to different tests and experiments where experiment results may be entered and calculated.

Here you can also export experiments into PDF format for printing and saving.

Report

The reports section fulfills many requirements for regulatory and accreditation standards. It allows for drafting MV details, background information and experiment setups. Reports offer built in templates that can be added.

Setting Approval States

To set the Approval State in an MV select the approval state on the left side navigation. A modal will appear allowing you to enter in a comment about status change. Adding a comment is required for proper laboratory protocol and traceability. After entering in a comment the status change and comment will append to the MV.

Sharing an MV

Share via Email

Sharing via Email can share the MV via email with a link to access the MV in a read-only view. Navigate to the Reports section of your MV and select Share at the top right. A modal will appear where you may enter up to 3 email addresses. Note: Only registered Cualia members may access MV’s shared over email.

Share via Public Link

MVs may be shared via a public link. This is useful for medical labs that require transparency in their processes for public image or government mandate/recommendation. To share an MV via public link navigate to the Reports section of your MV and select Share at the top right. A modal will appear allowing the toggle of the public link. After toggling, the MV link in the modal may be shared. Visitors will not have to be logged into Cualia to access the MV.

Export the Report to PDF

To Export the Report to PDF, navigate to the Reports section and select Preview. You will be directed to a PDF output that can be printed or saved. The Customize button allows for export configuration.

Export Report to PDF Customization Options

Customization Option
Description
Remove Cualia Branding
Hides the Cualia.io logo on the right side of the header. (Only available with the Organization Plan)
Remove Watermark
Hides the Cualia.io watermark on ever page. (Not available on the Free Plan)
Show Logo on Header
Sets whether to show your company logo in the header. To set the Organization logo visit settings.
Show Header on All Pages
Sets whether to show the header. When active the header will still show up on the cover page. (Always active on the Free Plan)
Show Logo on Footer
Sets whether to show your company logo in the footer. To set the Organization logo visit settings.
Show Footer on All Pages
Sets whether to show the footer. When active the footer will still show up on the cover page. (Always active on the Free Plan)

Export Test and Experiments to PDF

To Export Tests and Experiments to PDF navigate to the experiment for printing. On the top right select the Preview button to expand a set of options.

Export Experiment Options

Option
Description
Print Test Experiment
Prints only the experiment on the page
Print All Test’s Experiments
Prints all the experiments for the test
Print All Test Experiments
Prints all the experiments from all of the tests in the MV. (Not available on Free Plan)

After selecting an option you will be directed to a PDF output that can be printed or saved. The Customize button allows for export configuration.

Export Experiment to PDF Customization Options

Option
Description
Remove Cualia Branding
Hides the Cualia.io logo on the right side of the header. (Only available with the Organization Plan)
Remove Watermark
Hides the Cualia.io watermark on ever page. (Not available on the Free Plan)
Include Sample Results
The PDF will include the data tables from the experiment. Between Experiments and After Experiments toggle will set the data tables to be appended directly after their associated experiment or at the end of the PDF.
Include Experiment Summaries
Includes the experiment summaries generated from the experiment
Show Logo on Footer
Sets whether to show your company logo in the footer. To set the Organization logo visit settings.
Show Footer on All Pages
Sets whether to show the footer. When active the footer will still show up on the cover page. (Always active on the Free Plan)

FAQs

I don’t know anything about MVs

Don't worry! Each page of our documentation provides well-founded practices and step-by-step guidance on how to conduct each MV experiment. We've designed the instructions to be user-friendly, even for those new to Method Validations and Verifications.

If you have any questions or need further assistance, please don't hesitate to reach out to us at support@cualia.io. We're here to help you every step of the way.