Deploy in Less than a Week: COVID-19 LIMS Preconfigured with FDA Approved COVID-19 Biobanking & Clinical Tests, Reports and Workflows

Rapid Deploy: A Preconfigured, CLIA and ISO 15189 Compliant COVID-19 LIMS for SARS-CoV-2 Diagnostic Testing & Research Laboratories

Out of the Box: CDC/CSTE/FEMA eReporting of COVID-19 Test Results

Deploy in Less than a Week: COVID-19 LIMS Preconfigured with FDA Approved COVID-19 Biobanking & Clinical Tests, Reports and Workflows

Rapid Deploy: A Preconfigured, CLIA and ISO 15189 Compliant COVID-19 LIMS for SARS-CoV-2 Diagnostic Testing & Research Laboratories

Out of the Box: CDC/CSTE/FEMA eReporting of COVID-19 Test Results

Deploy in Less than a Week: Preconfigured COVID-19 Testing, Research & Biobanking Workflows Using CloudLIMS, an in the Cloud COVID-19 LIMS

Clinical testing and research laboratories across the globe are working on a war-footing to test and find a vaccine for the novel coronavirus disease (COVID-19). CloudLIMS has already helped multiple labs get up and running in less than a week using FDA approved, preconfigured workflows. Some of the major challenges faced by COVID-19 testing laboratories are as follows:

Rapid configuration of FDA approved COVID-19 test workflows.
Development, standardization, and validation of new methods for testing COVID-19.
Reporting test results as per FDA and CDC guidelines.
Following international regulatory guidelines, such as CLIA, ISO 15189:2012 and HIPAA.

Biobanks store and provide high-quality COVID-19 specimens and associated metadata to expedite research and clinical trials on COVID-19. Like clinical laboratories, biobanks too face numerous challenges:

Rapid Deployment of CDC approved COVID-19 biorepository SOPs.
Training biobank staff in handling and processing COVID-19 specimens.
Locating stored specimens, and ensuring proper packaging and shipment of COVID-19 specimens.
Following international standards and best practices, such as ISO 20387, EU GDPR, and ISBER Best Practices.

A Schematic Representation of a Preconfigured COVID-19 Diagnostic Testing Laboratory Workflow

Receiving Test
Request

Receiving
Specimens

Batch Accessioning
of Specimens

Processing
Specimens

Isolating
Viral RNA

Conducting
RT-PCR Test

Detecting
Amplified cDNA

Importing Results
to a LIMS

Validating Test
Results

Submitting Reports
to FDA & CDC

Sharing
Test Reports

Disposing
Specimens Safely

COVID-19 LIMS Software for Coronavirus Diagnostic Testing Labs, Research Labs and Biobanks

CloudLIMS is a preconfigured, scalable, in the cloud COVID-19 LIMS for COVID-19 research, diagnostic testing laboratories, and biobanks. CloudLIMS is preconfigured with COVID-19 specific tests, such as RT-PCR, serological tests for the detection of IgG/IgM antibodies, Enzyme-linked Immunosorbent Assay (ELISA), neutralization test, and Rapid Diagnostic Test (RDT). Furthermore, it is configured with COVID-19 and other infectious disease workflows and reporting templates for quick reporting of test results. CloudLIMS can be easily configured to support new test methods, assays, and reporting requirements, including those of FDA and CDC, avoiding time-consuming customization. The preconfiguration helps minimize onboarding time and enables laboratories to go-live within just a couple of days. CloudLIMS can be accessed anytime, anywhere, is easy to deploy, and enables COVID-19 laboratories to quickly automate without the need to invest in IT infrastructure or personnel.

CloudLIMS customers have realized benefits in the following ways:

Meet regulatory guidelines and standards such as CLIA, HIPAA, GCP, EU GDPR, 21 CFR Part 11, ISO 15189:2012, ISO 20387:2018, and ISBER Best Practices
Generate custom test reports to comply with the FDA and CDC reporting guidelines
A self-serve client portal to enable physicians to place diagnostic test requests, track request status in real-time, download test reports and invoices
Maintain a read-only audit trail to automatically record laboratory activities with a date and time stamp
Customizable forms to manage COVID-19 specimens, patient data, diagnostic tests and their results, clinical studies, kits, freezer inventory, and specimen shipment
Safeguard PHI (Protected Health Information) of patients by assigning role-based PHI access to authorized personnel only

Certificate of Analysis

Seamlessly Follow CLIA, ISO 15189, and HIPAA Guidelines

Anonymize PHI of patients to protect sensitive data from unauthorized access by assigning role-based access to authorized personnel only.

Manage training and competency records of laboratory personnel and regularly monitor their performance for quality assurance. This helps laboratory managers to assign tasks only to the person with appropriate training, competency, and experience to perform the tasks efficiently.

COVID-19 LIMS Manage Laboratory Staff Training

Manage records of analytical instruments, schedule instrument calibration and perform preventive maintenance as defined by the instrument manufacturer or laboratory's internal practices. CloudLIMS helps you maintain calibration and maintenance results, and records of functional checks performed before use.

Manage documents, such as SOPs for COVID-19 specimen handling, track the revision history of documents, and ensure document control. CloudLIMS helps ensure that laboratory personnel refer only to the latest version of documents. Furthermore, CloudLIMS helps assign document access privileges to personnel based on their roles.

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Advantages of CloudLIMS - A Complete COVID-19 LIMS Software

Manage Patients/Subjects

Seamlessly manage data of the Person Under Investigation (PUI), including their demographic details, informed consent, symptoms, clinical course, travel history, past medical history, and pre-existing medical conditions.

Manage COVID-19 Specimens

Assign unique system-generated or user-defined IDs to specimens, manage specimen data, generate barcodes for specimens, scan barcodes to quickly import specimens in CloudLIMS, and print labels. You can import specimens or aliquots from a file, maintain a specimen Chain of Custody (CoC), and track each specimen throughout its life cycle.

Manage COVID-19 Diagnostic Tests & Test Results

Manage various preconfigured tests such as RT-PCR and serological tests, maintain test CoC, configure flagging sets to automatically flag COVID-19 positive results. You can include positive, negative and inconclusive test results and patient demographic details while reporting reports to comply with the FDA and CDC reporting guidelines. Longitudinal studies of the patients, with test results of a period of time, can also be maintained.

Digital Issuance of Test Reports

Deliver COVID-19 test reports to patients at their registered email addresses and mobile numbers. As soon as a patient's test report is validated and released, it is added to the patient's record. You can then directly email the test report or push it to a mobile app as well as the physician on file, reducing turnaround time and enabling quick decision making for treatment, quarantine and isolation, curbing further spread in the community.

Manage COVID-19 Diagnostic Kits

Manage preconfigured kits, such as IgM/IgG antibody detection kits, SARS-CoV-2 Fluorescent PCR Kits, Personal Protective Equipment (PPE) kits along with their initial and current quantity. You can configure your laboratory kits as well. You can set reminders to receive alerts if the current number of kits is less than a specified quantity, ensuring timely ordering of kits.

Manage Workflows & Enforce SOPs

Configure workflow templates and streamline your laboratory workflows with ease. The personnel assigned to the first task in the workflow can commence it. After completing a step, it can be marked as complete so that the next step opens for the next person. The step can only be performed if the steps before it in the workflow (if any) are complete, enforcing the laboratory staff to follow established SOPs.

HIPAA-Compliant Patient Portal

CloudLIMS's all-in-one HIPAA-compliant, secure, cloud-based patient portal enables COVID-19 diagnostic laboratories to offer direct-to-patient services. The seamless communication with patients allows for better customer service and minimizes turnaround time.

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Securely Deliver COVID-19 Test Results via Folio’s Mobile App

CloudLIMS’s integration with Folio enables you to securely deliver COVID-19 results and certifications directly to patients via Folio’s biometrically secure mobile app. The Folio mobile wallet on patients’ smartphones enables them to receive, store and share their COVID-19 test results digitally as soon as the results are available, minimizing the wait time. The test results issued include a unique secure QR code to facilitate contactless result validation, enabling COVID-19 patients to assert their test results, anytime, anywhere. This functionality eliminates any chances of lost or misplaced results and the need to print test reports.

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CloudLIMS Integrations

Clinical diagnostic testing laboratories receive hundreds of COVID-19 specimens on a day-to-day basis. One of the most common and reliable tests used for testing COVID-19 specimens is RT-PCR, a real-time reverse transcription polymerase chain reaction (RT-PCR) test for the qualitative detection of RNA of SARS-CoV-2. DNA sequencing is done for the confirmation of test results if required. Manual transfer of analytical data of thousands of specimens from RT-PCR instruments and other analytical instruments to a LIMS is error-prone and reduces laboratory efficiency. For minimizing the test turnaround time, it is important to automate the data transfer process. CloudLIMS can be seamlessly integrated with analytical instruments for bi-directional data transfer, thereby reducing turnaround time and eliminating chances of transcription errors.

How Does CloudLIMS Support Instrument & Software Integrations for COVID-19 Testing Labs?

CloudLIMS supports integration with analytical instruments and software through the following methods:

Instrument Integration:
CloudLIMS is preconfigured to seamlessly integrate with COVID-19 testing instruments, such as RT-PCR, NGS instruments, for bi-directional data transfer. CloudLIMS’ REST Application Programming Interface (API) enables developers to read and write data from/to an analytical instrument, ensuring data integrity and minimizing turnaround time.
Software Integration:
CloudLIMS' Rest API is preconfigured to support integration with third-party software such as EMR, EHR, LIS, Patient Registries, etc. It can be integrated with the electronic reporting system of CDC/CSTE, FEMA, and other e-reporting tools, thereby automating reporting of test results. Furthermore, it can be integrated with medical or clinical billing software to effectively manage revenue cycles and minimize billing errors, enhancing customer experience.

Follow Regulatory Guidelines and Standards

CloudLIMS' COVID-19 LIMS Software Functionality

Manage Studies
Manage various COVID-19 related studies, such as population-based cohort studies, viral genome mutation studies, and molecular epidemiological studies. You can associate each study with specimens, patients, and generate custom study reports. You can batch import study records from a file, saving time and eliminating chances of manual errors.

Manage Packaging and Shipment of COVID-19 Specimens
Assign a unique ID to each incoming and outgoing shipment, associate each shipment with COVID-19 specimens, and track all shipments right from the origin to the destination to avoid misplacing biohazardous specimens.

Locate Stored Specimens
Create hierarchical storage units to mirror your storage inventory, assign COVID-19 specimens to storage units automatically based on barcodes, and quickly locate stored specimens whenever required for quality control checks or for shipment to research laboratories.

Inventory Management
Manage laboratory inventory such as reagents, laboratory coats, gloves, surgical masks, and import inventory records from a file. Furthermore, you can associate each inventory item with specimens, patient ID, diagnostic tests, and edit multiple inventory records simultaneously.

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What Our Customers Say About Us

"MOgene LC, a high complexity CLIA-certified lab, was looking for a secure system to automate and streamline the diagnostic operations, especially after the onset of the COVID-19 pandemic. As there was high demand of COVID-19 test requests and an urgent need for automation, we quickly zeroed in on CloudLIMS to meet our data management, automation, and compliance requirements. The CloudLIMS team not only mirrored our workflows, but also integrated with our clients as well as other vendors’ patient portal systems, right from patient registration to test report delivery. This definitely is a remarkable addition to our quality systems. I am happy with CloudLIMS’s flexibility and exceptional support during the whole process!"

- Kazima Saira, Ph.D
Lab Director
MOgene LC
USA

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