Free eBook: A Comprehensive Guide to Regulatory Compliance for COVID-19 Testing Labs
Deploy in Less than a Week: Preconfigured COVID-19 Testing & Research 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:
A Schematic Representation of a Preconfigured COVID-19 Diagnostic Testing Laboratory Workflow
COVID-19 LIMS Software for Coronavirus Diagnostic Testing and Research Labs
CloudLIMS is a preconfigured, scalable, in the cloud COVID-19 LIMS for COVID-19 research and diagnostic testing laboratories. 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:
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.
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.
Supports management of documents such as Standard Operating Procedures (SOPs), validated standard test methods, drawings, manuals, and enables their access to authorized personnel.
Advantages of CloudLIMS - A Complete COVID-19 LIMS Software
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.
Employers are hard-pressed to provide workplace COVID-19 testing for their employees while ensuring a safe working environment, complying fully and minimizing risks. Most are cognizant of the fact that any asymptomatic employee can be a carrier and easily infect the entire workforce. This could easily translate to massive man-hour losses for the company. Most importantly, the health and safety of the staff and their families would be greatly compromised.
With this realization, employers must conduct accurate & frequent testing to ensure the safety of all their employees.
As we adapt to “living with the novel coronavirus,” communities, public health organizations, neighborhoods, corporates, and similar institutions need to take COVID-19 safety precautions and accelerate testing. Mobile or pop-up COVID-19 diagnostic laboratories facilitate field-based testing and bring COVID-19 testing to all areas, no matter where people live or work. Mobile testing laboratories can be quickly deployed in hot spots, underserved communities, and workplaces. Widespread and easily accessible testing is crucial to meet the testing demand and prevent the spread of COVID-19 in the community. Consequently, public and private organizations are looking for cost-effective yet reliable methods for onsite testing that save time and space.
Schools & Universities Set Up
After a long period of remote classes, learning institutions are gearing up for physical reopening. As much as this may sound exciting, it is scary at the same time. The reason being that COVID-19 is still with us at large. If anything, new infectious variants are emerging with time. How can schools and universities guarantee the safety of their students and staff as they resume in-person classes?
Those in congregate settings such as learning institutions are at an increased risk of contracting COVID-19. According to the Centers for Disease Control and Prevention (CDC), the early detection and isolation of infected individuals in such institutions will help to reduce the spread of SARS-CoV-2. Therefore, administrators at such institutions need to take extra measures to ensure the safety of their staff and students as they resume in-person classes. Widespread testing is crucial to identify infected students and isolate them to curb the spread of the virus. Other measures that learning institutions need to implement include hand washing, social distancing, using face masks, ensuring adequate ventilation, and vaccinating staff and students.
Clinics & Physician Office Labs
COVID-19 testing is an effective strategy to combat the global pandemic that has so far resulted in millions of deaths globally. While most testing is usually carried out in third-party labs, clinics and physician offices provide an opportunity for onsite testing that increases the efficiency of testing and reduces associated costs at the same time.
Physician office labs (POLs) improve patient care because they facilitate early diagnosis and consequently early initiation of treatment. When physicians have an in-house laboratory, they can test their patients immediately whenever they deem it necessary. This also means that they can access test results sooner and embark on a clinical course without any delay. Such a process minimizes sample loss or mix-ups that may occur during the transportation of samples from physician offices to an offsite testing laboratory.
Instrument and Software Integration
COVID-19 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 and software 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: