Streamline and Automate Workflows Using CloudLIMS - A SaaS, LIMS for Clinical Diagnostic Labs
Clinical diagnostic laboratories are a primary source of medical and healthcare data and generate massive amounts of data on a daily basis. Clinical diagnostic data is crucial for disease prognosis and for providing personalized healthcare to patients. Clinical diagnostic laboratories face numerous challenges daily. These include securely managing biospecimens and patient consent, safeguarding sensitive patient data, managing clinical tests and their results, delivering test reports to patients and providers, and managing resources, such as personnel, instruments, and consumables, besides following best practices and regulatory guidelines such as HIPAA, EU GDPR, CLIA, ISO 15189:2022, etc.
A Schematic Representation of a Typical Clinical Testing Laboratory Workflow
CloudLIMS - An All-in-One Healthcare LIMS Software
CloudLIMS is a purpose-built, scalable, SaaS, in-the-cloud clinical diagnostic LIMS. It grows with your diagnostic laboratory by supporting your data management, automation, and regulatory requirements. With a cloud solution, the clinical diagnostic LIMS can be accessed anytime, anywhere, is easy to deploy, and enables clinical diagnostic 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, EU GDPR, 21 CFR Part 11, and ISO 15189:2022.
- Generate custom test reports to comply with the FDA, CDC, and state reporting guidelines.
- A self-serve cloud-based, HIPAA-compliant physician and patient portal to enable physicians and patients to place test requests and track their status in real-time, and securely download test reports from anywhere, anytime.
- Maintain a read-only audit trail to automatically record laboratory activities with a date and time stamp.
- Customizable forms to manage patient data specimens, diagnostic tests and their results, kits, freezer inventory, and specimen shipment.
- Safeguard Protected Health Information (PHI) of patients by assigning role-based PHI access to authorized personnel only.
- A flexible data model to seamlessly configure and accommodate specific workflow requirements avoiding costly customization.
Clinical Test Report
Seamlessly Follow CLIA, ISO 15189, and HIPAA Guidelines With Our Medical Lab Management Software
Anonymize the 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 assign tasks only to the person with the appropriate training, competency, and experience to perform the tasks efficiently.
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.
Seamlessly manage documents, such as procedure manuals, instrument maintenance manuals, standard operating procedures (SOPs), validated standard test methods, drawings, and manuals, and enable their access to authorized personnel. You can send documents for periodic review and approval to authorized personnel and ensure that only the latest version of documents is accessible to all authorized personnel.
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.
CloudLIMS - A Complete Clinical Diagnostics LIMS
Instrument & Software Integration
Clinical testing laboratories receive hundreds of samples and generate massive volumes of analytical data on a day-to-day basis. Manual transfer of data from instruments such as blood gas analyzers, RT-PCR, digital PCR, LC-MS, GC-MS, ICP-MS, ELISA, HPLC, Nano LC, and spectrophotometers, and software such as HIS, LIS, EMR, EHR, participant registries, advanced MD, and Quickbooks to a LIMS is error-prone and time-consuming. For effective management of growing data volumes and laboratory automation, instrument and software integration is indispensable. Instrument and software integration facilitates data transfer from analytical instruments and software to a LIMS, thereby eliminating chances of transcription errors and data redundancy, and ensuring data integrity. Furthermore, it helps in automating laboratory workflows, thereby saving time and resources, reducing turnaround times, and enhancing efficiency.
How CloudLIMS’ Medical Diagnostic Software Supports Instrument and Software Integration?
CloudLIMS supports instrument and software integration in the following ways:
- Instrument Integration: CSV/XLS is a standard output file type generated by most analytical instruments. The CSV file mapping enables data to be imported from multiple instruments into a LIMS. CloudLIMS periodically reads instrument-generated CSV files and maps the headers present in the files with the correct fields in CloudLIMS, thereby transferring the analytical data to CloudLIMS seamlessly.
- Software Integration: CloudLIMS’ Rest API can be configured to support integration with third-party software such as EMR, EHR, LIS, Patient Registries, etc. CloudLIMS can be preconfigured to upload results to 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 and transferring the analytical data to CloudLIMS seamlessly.
Follow Regulatory Compliance
CloudLIMS' Medical Lab Management Software Functionality
How CloudLIMS Supports COVID-19 Testing Workflows
CloudLIMS has helped multiple coronavirus testing labs get up and running in less than a week using FDA-approved, preconfigured workflows. 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 the 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 diagnostic laboratories to quickly automate without the need to invest in IT infrastructure or personnel.