free-lims

[free-lims]

ELEVATING QUALITY THROUGH LIMS TRACEABILITY: UNLEASHING THE POTENTIAL OF LIMS

In today’s post-pandemic world, quality is more crucial than ever in every industry. Whether it’s healthcare, manufacturing, food & beverage, or research, organizations are dedicated to ensuring that their products and services meet the highest standards. One crucial element that plays a significant role in promoting quality is data traceability. For instance, in research, without the ability to validate research data and ensure that every piece of information is accounted for, you run the risk of your efforts going to waste. In the food & beverage industry, globalization of the food supply chain has led to increased availability of exotic foods, but it has also amplified the presence of pathogens, with the FDA reporting a five-fold increase in identified pathogens compared to 50 years ago. Ensuring traceability is paramount to combatting this issue.

Thus, widespread adoption of lab technology, such as a Laboratory Information Management System (LIMS), becomes imperative. In this blog post, we will explore the ways in which LIMS data traceability promotes and safeguards quality, enabling organizations to thrive in a competitive landscape. But first, let’s understand what data traceability essentially is.

What is Data Traceability, and Why is it Important?

Imagine a scenario where a critical issue arises, and you need to investigate the root cause. How confident are you in your ability to trace back the associated data with that particular process or product? Data traceability, the ability to track and document the origin, transformation, and flow of data, is a powerful mechanism that not only enhances transparency but also promotes quality in diverse sectors. With data constantly evolving, recording every detail becomes indispensable. By validating data and ensuring its trustworthiness, traceability enhances overall quality. Efficiency is another key benefit of traceability, as researchers save time by avoiding errors and effortlessly organizing data. Additionally, data traceability ensures seamless lab compliance, simplifying adherence to quality standards and regulatory guidelines.

How Does LIMS Ensure Traceability?

LIMS traceability helps bolster quality in the following 3 ways:

Maximizing Compliance and Confidence in Lab Audits: Lab audits play a crucial role in ensuring compliance with protocols and industry standards and the production of high-quality, well-documented results. Implementing a LIMS is invaluable for meeting these requirements. A LIMS automates documentation processes and captures extensive metadata beyond the standard lifecycle, mapping data to sample numbers, aliquots or derivatives, and test IDs. LIMS traceability allows meticulous documentation of the complete lifecycle of each sample and automatic tracking of every status change attributing it to the responsible person and location. This eliminates concerns about missing or inaccurate information, enhancing data reliability. Labs can define metadata for various workflow steps, ensuring comprehensive logging of actions and observed results. Timestamped and uploaded into the LIMS, this data can be easily referenced, flagged for changes or errors, and acted upon as needed.

Enhancing Quality Assurance with Automated Specification Checks: For labs testing products to specification, LIMS traceability is indispensable. Storing product specifications in LIMS allows automatic comparison of test results against predefined limits. Any out-of-specification results are flagged, prompting immediate investigations for timely resolutions. A LIMS enables specifications to be displayed on client reports like certificates of analysis (CoAs) while providing lab managers easy access to metrics on out-of-specification instances for management reporting. A LIMS workflow can block samples from progressing unless they meet quality standards or if their processing method differs from the pre-defined SOPs, reducing errors and transcription time. Additionally, a LIMS facilitates recording investigations, a fundamental feature for labs handling testing anomalies. Analysts and lab managers can review test results alongside associated investigations, ensuring transparency and closure. Integration with electronic Quality Management Systems (QMS) enhances investigation traceability, offering a complete record of sample data.

Streamlining Laboratory Workflow with Barcode Integration: Barcodes play a crucial role in reducing processing errors by automating sample identification within a LIMS. LIMS-generated barcodes ensure unique and accurate sample identification, mitigating the risk of misidentification and associated consequences. In a lab setting, where distinguishing samples visually can be challenging, barcodes provide a reliable safeguard. Scanning barcodes eliminates the need for manual data entry verification, saving time and guaranteeing traceability. Moreover, barcodes can be extended to track lab supplies, tests, sample batches, and potential issues. With LIMS handling these complex tasks automatically, labs gain improved efficiency and easy access to vital information. Implementing a LIMS becomes a compelling choice for all kinds of laboratories seeking enhanced accuracy and streamlined operations.

The inherent automation in LIMS ensures that final results align with standard operating procedures (SOPs) and best practices established by the lab. This instills confidence that samples were processed accurately, checked for quality, and underwent the necessary tests outlined in associated SOPs. Validated results aid in determining sample acceptability. All actions and subsequent outcomes are logged to specific samples, providing a comprehensive audit trail.

From a compliance perspective, a LIMS supports the lab’s quality assurance process by enabling traceability of samples and results. Thanks to LIMS traceability, every sample, and its associated data can be traced back, revealing the generation process, responsible individuals, and the complete lifecycle of each test or sample. This level of transparency and accountability strengthens compliance efforts. With the ability to defend processes in the event of an audit, labs can confidently demonstrate compliance. Lab managers can also trust their team’s accuracy and efficiency in performing their roles, knowing that comprehensive data is securely stored and easily accessible.

Conclusion

Ensuring high-quality standards is paramount to delivering effective products, services, and processes. For labs, maintaining confidence in their data requires robust quality measures. This can be achieved using a LIMS. At the core of every LIMS lies traceability, automating oversight across samples and testing. This traceability offers a multitude of quality-promoting benefits, including streamlined audits, automated specification checks, and seamless barcode-integrated workflows. By embracing a LIMS, labs can gain an edge over their peers, as quality reigns supreme in every industry. Source: https://freelims.org/elevating-quality-through-lims-traceability-unleashing-the-potential-of-lims/

#LIMSTRACEABILITY

[free-lims]

[free-lims]

Discover FreeLIMS, the cutting-edge, open-source Biobanking LIMS software designed to streamline your research processes. With advanced features, intuitive interface, and zero cost, FreeLIMS empowers your lab with efficient sample management and data tracking. Unlock the potential of your biobanking projects today! #FreeLIMS #Biobanking #ResearchEfficiency

[free-lims]

BIOBANKS: MOVING UP THE VALUE CHAIN IN DIGITAL HEALTH RESEARCH

The global burden of diseases has shifted from communicable to noncommunicable diseases, and so has the focus of medical research. Around 41 million people die each year due to noncommunicable diseases, which is equivalent to 74% of all deaths worldwide. Rising cases of chronic and difficult-to-treat conditions such as cancer, diabetes, Alzheimer’s, and cardiovascular diseases have catalyzed medical advances in areas such as genomic and other -omic-driven research. This, in turn, has accelerated the demand for complex and diversified biospecimens and disease-specific biomarkers to meet the emerging needs of the scientific community. At the same time, there has been an all-round adoption and integration of technology and informatics in healthcare research. In this blog, we delineate the benefits of biobanking in scaling the value chain of digital health research.

What is Digital Health Research?

Digital health is an umbrella term that encompasses different kinds of digital technologies that have been adopted to enhance healthcare delivery, such as health information technology (IT), telehealth, mHealth, telemedicine, and personalized medicine.

On the other hand, digital healthcare research refers to the use of digital health tools such as software and mobile apps to enhance clinical research. Such tools enhance the efficiency in medical research and hence may lead to better medical outcomes as drugs are introduced sooner to the market.

For example, electronic consent forms eliminate time-consuming clinical paperwork and are easy to access from remote locations. The use of phones and tablets makes it easy to collect personal health information that is useful for developing personalized medicine.

Biobanks — A Key Driver for Digital Health Research

Digital health research is a progressive process that allows for the continuous accumulation, processing, and dissemination of relevant clinical data and information. The number of clinical studies has increased dramatically in the past couple of years. Biobanks help clinicians leverage digital health technologies to keep up with the increasing clinical research demands. At the same time, digital health provides a technological platform that allows clinical researchers to exploit the full potential of modern biobanking. Digital tools provide a competitive advantage to biobanks. Here is how:

1. Track Biospecimens Through the Sample Lifecycle

Digital tools allow biobanks to track biospecimens from collection to disposal and everything in between. Furthermore, digital technologies tools also collect and store phenotypic and demographic information related to biospecimens that are useful drivers of precision medicine.

2. Leverage Paperless Biobanking

Digitization eliminates paperwork in biobanking processes and hence reduces errors and increases efficiency. It allows for online consent collection, evaluation, and review of data. It also provides an avenue for virtual collaboration and therefore, faster turnaround times, improved decision-making, and increased productivity.

3. Integrate Disparate Data Sources

Digitalization enables biobanks to easily integrate biospecimen-derived data (such as -omics) and a wide spectrum of accumulated phenotypic information obtained from various digital health sources, such as Electronic Health Records (EHRs) and Electronic Medical Records (EMRs). The data can be collected and integrated over time to facilitate clinical research. Digital health technologies and tools offer several benefits, such as real-time analytics, customizable reporting, and virtual collaboration.

Why is Biorepository Software Important?

A biorepository management system enables biobanks to automate their processes for greater efficiency and productivity. A biobanking LIMS tracks biospecimens throughout their lifecycle and manages their associated metadata. A highly secure biorepository management system ensures that data integrity is maintained while supporting compliance with regulatory requirements. A cloud-based biorepository software provides an avenue for real-time access to biospecimen data remotely. Moreover, it facilitates easy sharing and collaboration between researchers.

Conclusion

Modern biobanks are highly specialized and may be specific to a population, disease, or geographical location. With digital tools, biobanks can broaden their scope and expand their reach to diverse biospecimen donors present at disparate locations. With digitization, biobanks can achieve zero error and greater efficiency, track samples and metadata, as well as ensure seamless interoperability with other sources of donor data. Automation through a biorepository management system boosts the efficiency and productivity of biobanks. At the same time, LIMS-enabled biobanks enable clinical researchers to achieve digital health research goals with ease.

Originally published at Biorepository Software

#biorepository software

[free-lims]

Do COVID-19 Drugs in Wastewater Pose a Threat to Aquatic Life?

A new study conducted by researchers from Pennsylvania State has found that the cocktail of drugs used to treat COVID-19 infection survive wastewater treatment and hence find their way to waterways where they pose a threat to aquatic life.

Drugs such as dexamethasone, remdesivir, antibiotics, and pain medications were used in significantly high amounts to treat COVID-19 infections between 2019 to 2021. These drugs have been excreted by humans into wastewater and persist despite wastewater treatment. Hence, they have been found to occur in wastewater at levels that are high enough to endanger aquatic life.

This finding underscores the need for wastewater testing to safeguard the well-being of the ecosystem. The results of this study were published in the Journal of Environmental Quality in September 2022. The world is just recovering from the COVID-19 pandemic, even though the full repercussions are yet to be understood. The pandemic caused a sharp spike in the use of pharmaceuticals that were used to manage symptoms of the infection. Patients with mild symptoms were treated with pain relievers such as naproxen and acetaminophen while hospitalized patients were put on antibiotics, antivirals such as remdesivir, and steroids such as dexamethasone. Some patients were also put on hydroxychloroquine, but later this drug was found to be ineffective against COVID-19 infection.

Details of the Study

This study was carried out by a large team of skilled researchers from Penn State Institute for Sustainable Agriculture and the U.S. Department of Agriculture. It started in May 2020 and concluded a year later, in May 2021. During this period, the researchers collected samples of wastewater from two Central Pennsylvania wastewater treatment plants on a weekly basis. The samples included both influent (incoming) and effluent (outgoing) from the two plants, one of which was based in a hospital.

The wastewater was analyzed for the SARS-CoV-2 virus in the influent. They also analyzed a variety of COVID-19 medications in both the influent and effluent at the two wastewater treatment plants.

Heather Preisendanz, an associate professor of agricultural and biological engineering at Penn State believes that the presence of high levels of pharmaceuticals used to treat COVID-19 in wastewater is a hazard. “This knowledge spurred concerns that increased use of pharmaceuticals during the pandemic could also lead to increased concentrations of these drugs in wastewater treatment plant effluent and potentially harm aquatic life,” she said.

Results of the Study

The following are the key findings from the study:

Remdesivir concentrations were linked to the number of hospitalized COVID-19 patients.

Dexamethasone concentrations were linked to the number of hospitalized COVID-19 patients on ventilators.

The influent to the hospital-based wastewater treatment plant had remdesivir and dexamethasone concentrations of 28% and 31% respectively.

The average removal efficiencies of remdesivir and dexamethasone were 39% and 56%, respectively.

No hydroxychloroquine was detected in the influent samples from either treatment plant.

The concentration of the virus was linked to the number of hospitalized patients and those on ventilators but was not directly tied to the concentration of COVID-19 drugs in wastewater.

Do COVID-19 Drugs Pose Dangers to Aquatic Life?

The following observations were made about the risks to aquatic life posed by COVID-19 pharmaceuticals:

The risk posed by remdesivir on aquatic life could not be quantified as no research has established the concentration threshold for safety.

Dexamethasone was found in concentrations that pose a low risk to fish.

The antibiotic trimethoprim was also detected in concentrations that could pose a low risk to aquatic life.

Sulfamethoxazole concentrations could pose a high risk to algae, which is a major food source for aquatic life.

Naproxen concentrations could pose a low-to-medium risk to aquatic life.

From the observations above, it is clear that COVID-19 pharmaceuticals pose a significant threat to aquatic life.

Why LIMS for Wastewater Testing Labs?

Laboratories that conduct wastewater testing provide helpful and actionable information on the quality and safety of wastewater that may find its way to waterways and endanger aquatic life. A Laboratory Information Management System (LIMS) enables laboratories to automate and streamline their processes including sample tracking, importing of test results from analytical instruments, and reporting of test results to clients and regulatory agencies. A LIMS for wastewater testing also supports full compliance with regulatory requirements and helps meet complex data management requirements. A cloud-based LIMS for wastewater testing offers a turnkey solution for higher throughput and maximum productivity for laboratories that test wastewater.

Is There a Need to Monitor COVID-19 Drugs in Wastewater?

From the study, it is clear that COVID-19 pharmaceuticals easily find their way into water bodies and hence pose a threat to aquatic life. Frequent water surveillance and testing are necessary to determine their concentrations and to initiate necessary action should they exceed the acceptable safety threshold. A Water LIMS enables wastewater testing laboratories to accurately test wastewater samples and digitize operations for maximum efficiency.

Originally published at https://freelims.org.

#LIMS for Wastewater Testing Labs

[free-lims]

3 Tech Trends in Environmental Testing to be on the Lookout for

The field of environmental testing has evolved significantly in the last decade and alongside it, the pressure to adapt to the shift has landed squarely on laboratories that test environmental samples. Laboratories need to perform a diverse range of analytical tests on environmental samples such as air, water, soil, and wastes (liquids, solids, or sludges). At the same time, laboratories have not been spared the economic upheavals that have cut across industries following the pandemic-initiated global recession. This has come with market consolidation and declining profitability. However, things are not as bad as they may seem. The market size for environmental testing is expected to surpass $17 billion by 2030, from $8 billion in 2023. What laboratories need is a lifeline to tide them over the recession period and accelerate productivity. In this case, leveraging technology seems to be it.

Here are three technological trends that are expected to gain momentum in 2023 and thereafter.

1. Automation of Laboratory Processes

While most environmental laboratories have already adopted some form of automation, we expect to witness an even greater uptake in 2023 and beyond.

Environmental laboratories face a myriad of challenges including the need to cut back on operational costs as well as a shortage of skilled and competent staff. At the same time, it is expected that the demand for environmental testing will grow exponentially in terms of volume and diversity of tests. Furthermore, environmental testing laboratories need to follow several regulatory guidelines such as NELAC (TNI), ISO 17025, RCRA, CERCLA, GLP/GALP, UCMR, CFR Title 40, CWA, NPDES, RCRA, UIC, besides state and local regulations. Managing huge volumes of test requests and data generated from them while meeting regulatory compliance can be overwhelming. This has created the need for informatics solutions.

Increasingly, more and more environmental testing laboratories are opting to automate entire workflows to maintain data integrity and eliminate manual errors. This includes processes associated with samples, tests, and data management as well as management of lab instruments, software, Standard Operating Procedures (SOPs) and personnel.

Automation presents several benefits, including data accuracy, the efficiency of processes as well as increased output. It also reduces the administrative workload and allows laboratory staff to focus on more specialized tasks. While the initial cost of switching from manual processes to automated systems can be high, this is likely to yield higher returns in terms of profits in the long run. Fortunately, automation technology for laboratories is now widely available, and consequently, automation has become relatively affordable for even small laboratories with meager budgets.

2. Cloud Computing

Cloud computing supports automation by providing remote and secure access to several IT resources that are hosted in the cloud. A survey conducted by Environmental Business International (EBI) showed that over 50% of environmental companies are planning to invest in cloud computing (IoT) in the 2020s.

Cloud computing allows laboratories to access computing services such as servers, databases, and software over the Internet. It enables real-time collaboration and cost-saving through economies of scale. Laboratories can easily store and access data from any location and at any time. Modern in-the-cloud systems, such as a cloud-based Laboratory Information Management System (LIMS), use world-class technology to beef up security and provide automated timely security updates. In multi-laboratory companies, a LIMS can centrally store data of all laboratories and manage diverse workflows of all laboratories, thereby eliminating data silos.

3. Artificial Intelligence (AI) and Machine Learning (ML)

AI empowers computers with the ability to “think” and execute actions without human input. Environmental testing laboratories can leverage AI and ML to improve experimental design, quickly analyze test results of multiple tests, and make data-driven decisions that may take days if done manually. Just like automation, AI reduces human error in laboratory processes and boosts productivity. The Environmental Business International (EBI) survey showed that over 50% of environmental laboratories are planning to invest in AI.

Apart from AI, the integration of LIMS with Augmented Reality (AR) and Mixed Reality (MR) solutions helps environmental testing laboratories to see SOPs and record observations. All these technologies are intended to increase efficiency in laboratories and boost output in tandem with the demands of 21st-century environmental testing.

A Greater Demand for an Environmental LIMS Software

From a value of $1.85 billion in 2021, the LIMS industry is expected to reach a value of $3.5 billion by 2030, growing at a CAGR of 7%. In a survey that was conducted by EBI, 95% of environmental companies indicated that they have the intention to invest in a LIMS. Most of these companies strongly believe that information technology is necessary for digitally transforming lab operations and for the evolution of the industry to the next phase. An environmental LIMS software automates laboratory workflows by integration with all instruments and software and ties in with other technological trends such as AI and ML.

A LIMS also manages and streamlines the entire sample life cycle, from sample accessioning to reporting test results to customers and regulatory agencies. Furthermore, a LIMS enables laboratories to meet stringent regulatory guidelines, flag out-of-specification results, analyze trends across a set of samples, track deviations from SOPs, and centrally manage multi-laboratory data with ease.

Leveraging The Latest Tech Trends Using an Environmental LIMS Software

Environmental testing is a profitable and competitive niche, but with a fair share of challenges at the same time. Forward-thinking laboratories can use the latest technology trends to pivot their operations so they can meet the stringent demands of environmental testing. Tech trends to be on the lookout for in the coming years include the automation of most laboratory processes, wide-scale adoption of cloud computing, and the use of artificial intelligence and machine learning. At the same time, more laboratories are expected to implement a cloud-based environmental LIMS software to digitally transform and future-proof their operations.

Originally published at https://freelims.org.

#environmental lims software

[free-lims]

5 Tips to Mitigate Clinical Trial Delays

It is quite common for clinical trials to face delays, and delays have almost become expected and acceptable. But unknown to many, clinical trial delays are not only costly but they also have a negative impact on patients’ health. This blog walks you through the common causes of delays in clinical trials and offers five tips to mitigate them.

Roughly, 85% of clinical trials experience some form of delay with about 94% of them being delayed by at least a month. Such delays constrain clinical trial budgets and in the long term, they shorten the patent window of a drug and hence minimize its profitability. The money lost to clinical trial delays has been increasing and is estimated to be in the billions of dollars.

Trial delays place an unnecessary burden on patients who have to wait for longer than they had expected. This may force some to exit the trial, and may cause even further delays to allow time for the recruitment of other participants. Delays in clinical trials cause delayed treatments and this may diminish patient outcomes. With all this in mind, it is imperative to understand the root cause of delays so as to come up with tenable solutions.

What are the Causes of Clinical Trial Delays?

Poor planning is at the root cause of most clinical trial delays. Clinical trials are dynamic and evolving and hence different factors must be considered in the execution of a successful trial. This means that proper planning must be in place. Delays in as many as 25% of all trials have been attributed to commercial barriers and operational issues. The increasing complexity of trials with a multiplicity of endpoints on most trials places undue pressure on researchers, and results in delays. Communication barriers may also arise when trials are being conducted in multiple locations. Site initiation delays due to missed dates and poor planning are common occurrences. Once the trial is underway, patient retention becomes a significant cause of delay with over 50% of patients not showing up for pre-screening or declining to give consent. Another 8% usually drop out along the way. Lastly, operating in a tough regulatory environment may significantly impede the progress of clinical trials.

How to Mitigate Clinical Trial Delays? Here are 5 Tips

Given the evolving complexities and regulatory hurdles in the clinical research environment, it can be difficult to beat all the odds that cause delays. However, here are five tips to overcome delays in clinical trials.

1. Ensuring Proper Planning

Most of the causes of clinical trial delays can be attributed to poor planning. It is important to run through the trial from end-to-end and troubleshoot potential problems prior to launching the actual trial. Establish a working relationship and pinpoint unique challenges at each study site. Furthermore, you need to ensure that all your team members are onboard and aware of all important dates of the clinical trial.

2. Prioritizing Compliance and Regulatory Requirements

Academic institutions and pharmaceutical companies have different requirements and protocols for reviewing clinical trials. Other regulatory requirements might also arise from the federal or state levels of governance. Failing to address these requirements in time may derail the clinical trial.

3. Having Appropriate Communication Channels in Place

Communication breakdowns cause misinformation and misunderstanding among the trial stakeholders. It should be clear from the start where instructions are taken from and how any information should be disseminated. Objectives and responsibilities of each party need to be defined clearly. To achieve this, it is important to have an information management system to minimize information and other communication errors.

4. Boosting Patient Retention

Delays in the system due to poor planning and communication breakdowns are a major cause of patient dropout. Patients need to understand the potential benefits versus risks of participating in the trial and be allowed to make an informed decision. Proper consent must also be taken prior to the trial. Clinical trial laboratories must take measures to boost patient retention through proper advocacy and communication.

5. Deploying a Laboratory Information Management System (LIMS) for Clinical Trial Management

A LIMS for Clinical Trial Management can help minimize delays in clinical trials by automating laboratory processes and streamlining workflows. A LlMS for clinical trial management manages samples and the associated patient information including consent, and supports regulatory compliance. Furthermore, it helps minimize delays in clinical trials and Contract Research Organization (CRO) operations.

Reducing Trial Delays Increases Profitability and Improves Patient Outcomes

The clinical research landscape has become increasingly difficult to navigate. Without proper planning, clinical trial delays are inevitable. This has hefty financial implications that are estimated to spiral into billions of dollars. When the entry of drugs to the market gets delayed, patient health is also jeopardized. Considering all that is at risk, it’s only prudent to seek tenable solutions to mitigate clinical research delays. A LIMS for clinical trial management automates workflows to reduce trial delays.

Originally published at https://freelims.org.

[free-lims]

Struggling to Manage Multiple Lab Equipment? A Laboratory Information Management System (LIMS) Can Make it Easy

Most laboratories invest a huge amount of money in procuring laboratory equipment. Therefore, laboratory managers should take necessary measures to effectively manage such an investment.

However, laboratories around the globe face the critical issue of improper equipment calibration and maintenance. It does not mean that laboratory staff neglect equipment or put them in their backpacks. It indicates that maintaining equipment records and ensuring proper calibration and maintenance of equipment with vigilance is challenging.

What are the consequences of improper lab management? There are several. Some of them are as follows:

Fast wear and tear of equipment

Inaccurate test results

Wastage of an enormous amount of time and money

Is there any solution to seamlessly manage laboratory equipment?

The answer is yes, it is a Laboratory Information Management System (LIMS). It maintains the efficiency of your lab’s instruments. With a LIMS in place, there is an assurance among lab staff that equipment will:

Receive timely maintenance

Get proper monitoring of performance over time

Save their time with automation

Generate accurate and valid results

Thankfully, there are several ways through which a LIMS helps efficiently manage laboratory instruments. Some of them are as follows:

A. Integrate with Instruments

Today, automation rules the world and no laboratory across the globe can ignore it. A LIMS can be integrated with laboratory instruments via an Application Programming Interface (API) or by mapping instrument-generated CSV/XLS files with the correct fields in a LIMS. This facilitates bi-directional data transfer between instruments and a LIMS, saving time and maintaining data integrity.

B. Manage Lab Equipment Schedule

It isn’t convenient for workers to arrange lab equipment for multiple tasks. With hectic schedules, keeping equipment free for sample processing or testing becomes challenging. A LIMS offers proper equipment scheduling by permitting only authorized personnel to reserve the equipment and access them when needed. A LIMS facilitates:

Easy tracking of the equipment schedule i.e. when equipment is in use and when it is not

Tracking equipment maintenance before or after use

Monitoring whether an instrument is in service or not

C. Ensure Effective Equipment Upkeep

Some complex equipment requires daily or weekly maintenance for smooth functioning. Laboratory managers prefer receiving timely email reminders for proper upkeep of lab equipment daily or weekly or as per the predetermined schedule. In such a scenario, a LIMS provides daily updates for general cleaning and equipment upkeep by:

Creating a log file after the completion of the maintenance work

Recording equipment cleaning work performed by staff members with a date and time stamp and an electronic signature

Storing maintenance-related documents for future reference

D. Identify Equipment Errors

It is possible that lab equipment sometimes malfunctions or does not work as expected. So, it becomes crucial for lab staff to maintain a deviation (or event) log. If they fail to record such events, it may lead to disastrous consequences and audit failures. A LIMS offers a system for the staff to enter key details that comprise vital data about equipment malfunctions and helps them to:

Spot faults quickly and prevent future malfunctions

Provide reliable information to the manufacturer and limit user error

E. Strengthen Data Security

With the advancement in online operations, the risk of data breaches and cyberattacks has increased manifold. It has become a daunting task to safeguard data and permit access to the data in a controlled way. A cloud-based LIMS software safeguards sensitive user data in several ways. Some of the ways in which a LIMS enhances data security are as follows:

Authenticating users through a two-factor authentication mechanism.

Restricting access to the system through log-in by either integrating it with Lightweight Directory Access Protocol (LDAP) for user authentication or providing access from an “identity server”.

Implementing data security filters to thwart online hackers from searching and exporting data, thereby restricting access to confidential information.

Furthermore, several other new measures ensure high-level data security. The first is a yearly risk assessment that helps determine likely risk factors and take risk mitigation actions. Secondly, staff must be given periodic training to apprise them of the latest incidents of cyberattacks and measures to prevent them.

Wrapping Up

The equipment must be in good working order to carry out daily lab operations efficiently. The staff and managers must ensure that lab equipment is checked regularly. Furthermore, the implementation of a LIMS system improves laboratory control and transparency while increasing efficiency through process automation and better equipment management. A LIMS helps centrally manage all crucial information related to lab equipment and enables staff to schedule equipment calibration and manage maintenance data.

Originally published at https://freelims.org.

#lims

[free-lims]

How to Assure 100% Operational Efficiency When Managing a Remote Clinical Lab

Nobody anticipated that the COVID-19 pandemic would result in a fundamental shift toward the remote working environment. Even clinical laboratories are switching to remote or hybrid work employment as the “new normal”. However, a clinical lab must implement a detailed work plan when operating in a remote setting. The laboratory must maintain its level of output and efficiency under challenging conditions so that personnel can work in remote places without any disturbances.

Several measures will help any clinical lab working in a remote setting to operate efficiently. Let’s venture more into it.

1. Working Efficiently from Geographically Dispersed Locations

When working remotely, laboratories can streamline their operations and reduce operational costs through:

Creation of centralized teams to review data efficiently

Utilization of agile resource models to recruit remote workers that can bring their experience to enhance productivity

Elimination of the need to acquire a large physical space, thereby reducing expenses

Provision of compliance and financial assistance

2. Conducting Field Work through a Remote Access LIMS

If your lab has a remote access LIMS that can be accessed using any Internet-ready device, conducting fieldwork, such as collecting samples and generating barcodes for tracking samples, can be easily accomplished. Moreover, staff working remotely for any clinical lab can capture patient data and transmit all data through a remote access LIMS to the lab in real time.

3. Offering Quick Healthcare Services to Patients

Who needs the best healthcare services at a fast pace? Of course, patients! By chance, several tools allow lab workers to evaluate past data instantly and check and deliver health updates to patients with 100% accuracy online.

The clinical setting has been made extraordinary by providing devices such as glucose meters to the patients and getting immediate updates that are beneficial to improve their health conditions.

Nevertheless, several healthcare professionals do not consider remote patient monitoring by laboratories a fit in today’s time and even consider it a waste of financial resources. Some of the drawbacks of remote clinical labs in their opinion are:

Stagnant growth of the lab staff with not much learning will hamper their productivity

Internet connectivity issues in remote areas can be a cause of concern for the smooth provision of healthcare services

Challenges Lab Managers Face in Remotely Managing a Clinical Diagnostic Lab

In current times, patients are more health conscious and demand regular diagnoses and checkups. Though laboratories are working hard to bring the best health services to people, they still face challenges while working remotely. Some of the most common challenges that global diagnostic labs face are as follows:

1. Longer Turnaround Time (TAT)

When working at remote locations, sometimes, labs depend on 3rd party processing units, which delays the delivery of test reports to patients. Similarly, they may face challenges in tracking samples and TAT effectively. The practical solution for online working staff is to utilize a remote access LIMS for fast-tracking and monitoring processes and leveraging automation to deliver test results to patients via SMS, emails, or a patient portal.

2. Managing Daily Stock

Managing and controlling daily stock is challenging, which can create trouble for lab staff. The best solution is to deploy a LIMS or inventory management software for managing stock and sending alerts when the count of inventory items falls below a specified threshold limit. It can be done from anywhere by the lab workers and will help in efficiently managing lab inventory.

3. Handling Samples in an Appropriate Way

The vital aspects of lab operations are sample tracking and handling, which remote working teams struggle to manage. If left in the lurch, it may severely impact service quality and may result in loss of samples. The way forward is to use barcoded samples and connect them with your lab software.

4. Data Confidentiality & Sharing

Remote lab teams always have a shortage of skilled staff, which might result in the online theft of sensitive patient data and thus tarnish the reputation of the respective lab. To counter it, labs can consider providing permission-based access controls via a LIMS software solution. It will offer a secure password for each employee and ensure confidential data remains protected.

What Methods Lab Managers Should Undertake for the Smooth and Efficient Running of Remote Clinical Diagnostic Labs?

For a diagnostic lab to operate smoothly and effectively, it is vital to provide exceptional results without exceeding deadlines. So, there are some practical measures that lab managers must implement to carry out the operation in an effective way.

1. Trust the Team to Achieve Tasks Successfully

Remotely operating a lab is a tedious job. Every staff must get training to uphold best practices as per the industrial standards and conduct lab functioning efficiently. Besides, trusting them by giving autonomy will boost their morale and improve overall performance.

2. Recruit a Remote QA Lab Assistant

In a laboratory setting, quality is a must. Hiring a QA manager will ensure better quality assurance by continuously reviewing data and guiding the staff to follow Standard Operating Procedures (SOPs).

3. Aptly Track Key Performance Indicators (KPIs)

Thanks to LIMS, it is now possible to accurately show how a lab is performing concerning its stated goals. Furthermore, working remotely necessitates establishing priorities for finding KPIs such as:

Monitoring of the environment

Identifying the lab’s requirements

Solving a specific problem

Apart from it, they will help lab managers find answers to the following questions:

What to measure that encourages and motivates the team?

How to ensure setting achievable objectives for the remote team?

Will the KPIs drive towards adopting new innovative changes?

How Does a Cloud-Based Diagnostics LIMS Serve as a Central Hub for Remotely Managing Modern Clinical Diagnostic Labs?

A cloud-based Diagnostics LIMS is valuable for clinical laboratories as it can help lab staff digitally record and track results and workflows precisely. In modern times, it has acted as a central hub by enabling staff to accomplish experiment write-ups, analyze lab data, see data patterns and offer information for regulatory dossiers with excellent efficacy.

Wrapping Up

The new reality of futuristic clinical laboratories is remote working as the younger generation yearns for more flexibility with a perfect work-life balance! So, the onus is on the clinical lab professionals to make remote working more efficient and safer. They must also incorporate cloud and networking-based digital solutions that will assist them in producing quicker, better, and higher-quality healthcare results with 100% efficiency.

Originally published at https://freelims.org.

#Remote Access LIMS #Diagnostics LIMS

[free-lims]

The Role and Relevance of Population Biobanks in Clinical Research

Scientists are only beginning to understand the multifactorial nature of diseases, but with large-scale biobanking, it may be just a matter of time before the dots connect. Genomics is paving the way for precision medicine and suitable treatment options for rare and difficult-to-treat conditions. This calls for large population-based biorepositories reflecting gene-gene and gene-environment interactions over time. If any success is to be achieved, there’s a need for international collaboration to achieve the required statistical power. This blog discusses the need and relevance of population biobanks as key drivers of clinical research in the future.

What is a Population Biobank?

A population biobank is best described as donations of thousands of biological specimens collected from members of the general population who might or might not be suffering from any disease. Most of these biological specimens are genetic material. However, a population biobank should not be confused with a genetic biobank which is a biorepository that only handles DNA material in order to understand the genetic determinants of disease, regardless of whether the samples were collected from the general population or not.

Population biobanks play a major role in identifying and analyzing genetic susceptibility to diseases and how lifestyle and environmental factors contribute to diseases. Population biobanks facilitate this by enabling researchers to analyze molecular data as well as the associated data such as clinical, imaging, and lab reports. A number of countries are already in the process of setting up population biobanks.

The Human Genome Project Laid The Foundation for Population Biobanks

The highly acclaimed Human Genome Project provided the stage for major breakthroughs in precision medicine, having successfully managed to sequence the entire human genome. This scientific miracle made it possible for researchers to begin to explore the link between genetics, disease, and response to treatment. However, translating this preliminary understanding into clinical benefits remains a challenge. A population-based approach to biobanking will give scientists multiple, varied and unbiased samples that will allow them to explore complex disease susceptibility genes.

Population Biobanks Are Powerful Tools in the Prevention of Chronic and Rare Diseases

Population biobanks play host to millions of genetic material as well as the related lifestyle, environmental, and clinical information. Researchers are able to analyze all this information and identify multifactorial causes of disease. This may provide breakthroughs in the treatment of chronic diseases such as Alzheimer’s, schizophrenia, cancer, diabetes, and asthma among others. This may also help scientists to establish triggers for adverse outcomes such as congenital birth defects and preterm births.

Population Biobanks Can be Used to Estimate Allele Frequency

Because of the diversity of varied specimens (from a large cross-section of participants from different ethnicities) in population biobanks, researchers are able to estimate allele frequency. This is the proportion of people in a population with a specific gene frequency that is instrumental in understanding the interplay between genetic and environmental factors and disease causation.

Population Biobanks Provide Modern Tools for Disease Prevention

In spite of major breakthroughs in genomics, their translation into clinical benefits has remained a mirage. Population biobanks are however promising to translate discoveries at the genetic level into a better understanding of complex diseases and hence the discovery of new and better drugs. What has been discovered from genomics so far has not been sufficient to alter current recommendations for patient care unless on a case-by-case basis. Research driven by population-based biobanking will bridge this gap and allow scientists to exploit the interplay between genetics and environmental risk factors for diseases. This research is needed not only for drug development but also for devising disease prevention strategies as well.

Role of a Biospecimen Management System in Population Biobanks

Population biobanks handle and process a ton of samples and sensitive patient data that’s the bedrock of clinical research. A Biospecimen Management System, also known as a Laboratory Information Management System (LIMS), offers a turnkey solution for labs through automation. A biospecimen management system offers end-to-end sample tracking and management and streamlines the entire biobanking workflow. A cloud-hosted biospecimen management system ensures remote access to biobank data and promotes collaboration while at the same time guarantees maximum data protection and security.

How Population Biobanks Can Shape the Future of Clinical Research

The world is at an unprecedented time with the evolution of -omics and precision-driven medicine. However, translational research remains elusive. Population-based biobanks store large volumes of biosamples harnessed from the general population. Population biobanks enable researchers to analyze genetic biomarkers in relation to medical history and environmental factors. They go a step further to offer information about allele and gene frequency in a population. The integration of population-based genomics with modern biobanking will provide scientists with the rare opportunity to tackle rare and complex diseases right at the genetic level. A biospecimen management system streamlines and automates operations of population biobanks, helps them overcome regulatory challenges, and assures data security at all times.

Originally published at https://freelims.org.

#biospecimen management system

[free-lims]

Economic and Ethical Issues Surrounding the Reuse of Clinical Biospecimens

According to the “ Global Biological Sample Handling Market Research and Forecast 2022–2028”, the biospecimen market worldwide is expected to grow at a rate of 8% throughout the forecast period. As the medical world moves towards genomics and precision medicine, the demand for high-quality specimens is increasing. Approximately 80% of researchers struggle to find high-quality, fit-for-purpose biospecimens to cover the entire scope of their research projects. As researchers are grappling with specimen deficits, laboratories all over the world are discarding close to three billion clinical specimens each year that could be used for clinical research and in the process generate revenue for these laboratories.

The Increased Demand for Biological Specimens

Precision medicine which is tailored to take into account individual differences such as genetics, environmental, and lifestyle factors is driving the demand for high volumes of biological samples. For example, a researcher investigating breast cancer would in the past perhaps require about 50 breast tissue specimens, now they will require a pool of about 500 specimens so that they can zero in on specific tumor tissue considering gender, race, gene mutations, past treatment, etc. To meet the rising demand, clinical research laboratories have to be innovative and forward-thinking. Is specimen reuse a suitable solution?

The Need to Reuse Clinical Biospecimens: Economic Considerations

Each day, laboratories discard tons of specimens as waste. These specimens include bodily fluids and tissues obtained from patients for specific purposes. Once the intended purpose has been met, laboratories are likely to dispose of specimens.

Procuring specimens for clinical research can be both time-consuming and expensive. This has compelled “out-of-the-box” solutions and one of them is having a marketplace for biological samples. Blood centers, biorepositories, and pathology laboratories are useful resources from where biological samples can be sourced for a common online biospecimen marketplace. Each specimen should be annotated with relevant information such as demographics, medical conditions, tests conducted, and clinical history of the donors.

An Online Biospecimen Marketplace is a Win-Win

An online biospecimen can be used to generate revenue for biorepositories. At the same time, a data-rich online marketplace will increase access to high-quality samples for clinical researchers. A digital marketplace for biospecimens is staggering in its diverse capabilities. At the same time, ethical considerations abound.

The Need to Reuse Clinical Biospecimens: Ethical Considerations

For biospecimens to be reused, researchers need to obtain prior consent from sample donors. Generally, informed consent must meet certain ethical considerations as outlined below:

Voluntary participation: Participants must not be coerced or persuaded to participate in the research.

Informed consent: The participants must express in writing or by signing that they have understood the research and given permission for their specimen to be used for the specified objective.

Anonymity: The specimen and information about the participants must be maintained in anonymity.

Confidentiality: Information relating to the participants must be maintained with utmost confidentiality.

Beneficence: There must be some benefits attached to the research for which the specimen is being collected. This also ties in with the principle of “do no harm”.

Results communication: The participants might wish to know the results that were obtained from the study, and hence that provision should be accommodated.

These are key ethical considerations that must be considered when collecting biological samples from volunteers. However, when the specimen is being reused, it may be difficult to meet some of these considerations.

If a specimen is to be reused, how can a researcher obtain consent for the different uses, some of which may not be clear at the start?

For the specimen to be reused, any of the following kinds of consent should be obtained:

Blanket: Specimen donor approves the usage of specimens for any type of research without the need for further consent

Broad: Specimen donor puts broad limitations on the type of research that their specimen can be used for

Checklist: A researcher states in advance the types of research that the specimen will be used for

Study-specific: Consent is given for specific types of studies

Are Patients Willing to Have Their Specimen Reused?

It appears that a majority of patients support specimen reuse but certain ethical considerations must be put in place. A recent “”study of patients’ opinions” published in BMC Med Ethics in June 2022 revealed the following:

Most participants acknowledged the importance of biospecimen reuse.

Participants were particularly uncomfortable with blood samples due to ethical beliefs and a misunderstanding of terms such as anemia.

Participants supported passive consent but preferred to be notified of the kinds of research that their samples would be used for and where the samples would be used.

A Clinical LIMS System Supports an Online Marketplace for Biospecimens

A Laboratory Information Management System (LIMS) is needed to automate and streamline processes in a clinical research laboratory. A LIMS is also useful in managing consent, studies, and patient and sample data. A cloud-based Clinical LIMS System enables data sharing in the marketplace and allows remote access at any time of the day.

Need for Culturally Sensitive Consent for Biospecimen Reuse

Precision medicine is driving the need for clinically appropriate specimens through the roof. However, specimen reuse raises several ethical issues, especially obtaining appropriate consent from participants. From research, it appears that a majority of patients acknowledge the need for specimen reuse to support clinical research. An online marketplace for biospecimens presents economic benefits for biorepositories and would go a long way in availing much-needed quality biospecimens for clinical researchers. A clinical LIMS system can help clinical research labs automate operations, anonymize sensitive data, and integrate with online biospecimen marketplaces to provide researchers access to a wide range of high-quality samples.

Originally published at https://freelims.org.

#Clinical LIMS System

[free-lims]

Make Your Data Actionable With These Six LIMS Reporting Tips

A Laboratory Information Management System (LIMS) is a laboratory software that helps automate sample and data management and also streamlines lab processes and facilitates integration with other systems. A modern cloud-based LIMS allows a lab to generate numerous concise and professional reports that can be used to guide the lab’s decision-making process. However, one needs to understand how to make the generated data and metadata actionable so as to derive the most value from the LIMS.

Here are six LIMS reporting tips to make your data actionable.

1. Understand the Different Kinds of LIMS Reports

A LIMS generates different kinds of reports from the data imported into it. Here is a breakdown of the most important ones that you should look for in a LIMS:

Analytical Reports

This type of report combines different lab inputs, such as the number of samples registered, tests carried out, and turnaround time (TAT), for comparative analysis. Analysis reports include test analytics reports and overall TAT reports.

Operational Reports

There are numerous types of reports produced by a LIMS, and they depend on the unique needs of a lab. The operational reports include reports such as completed tests, approved results, canceled results, lab performance results, and inventory reports among others.

Financial Reports

Financial reports are very important as they help a lab to keep track of the day-to-day revenues and expenditures. Financial reports generated from a LIMS include daily collections, physicians’ revenues, bill settlements, and pending bills among others.

2. On-Demand Reports

LIMS reports have traditionally been generated on-demand. This means that the systems administrator pre-configures templates and the lab staff members can populate the templates with fresh data and generate new reports. The good thing about this type of report is consistency. On the flip side, this type of report is rather rigid. Some LIMS allows flexibility through ad hoc reporting. This enables lab managers to customize reports by allowing them to add necessary elements to suit regulatory and customer requirements. However, the system administrator needs to ensure that no data corruption or misrepresentation occurs in the process.

3. Scheduled Reports

A LIMS can also generate scheduled reports at regular time intervals or based on pre-configured metrics. For example, a lab manager may want to keep track of the lab’s performance at a weekly or monthly interval. The LIMS will generate such a report based on the scheduled time intervals and automatically send out the report to the lab manager and other concerned persons.

4. Customize Your LIMS Dashboard

The dashboard of a LIMS is often an underutilized resource because most people do not understand the power that can be harnessed from real-time data visualization. Role-specific dashboards, for example, can be tailored to display Key Performance Indicators (KPIs) at a glance and hence help ensure that all lab activities are goal oriented. A LIMS dashboard can be configured to display all critical parameters that must be monitored constantly. For example, it may display the samples in a lab and at what stage of processing they are in. It may also display lab inventory, inventory items that are on the verge of depletion, and staff training records.

A key challenge with the LIMS dashboard is data overload especially when the data has been derived from several complex records generated over time. It is critical to always refresh the dashboard so that it displays the current data at all times.

5. Alerts

A LIMS can be configured to send out alerts when certain conditions are met or exceeded. However, alerts need to be well planned to avoid what is known as “ alarm fatigue”, a common occurrence in healthcare. If you’ve been to a hospital, you should be familiar with the incessant beeping of alarms that mostly go unattended. The same can happen when a LIMS is configured to send out too many alerts in the form of system notifications, emails, or text messages. It may be more efficient and productive to configure alerts to be sent out to specific people, for example, lab managers, or concerned staff members.

6. System Interfacing

Since a LIMS is the data center for a lab, it’s important to have it integrated with other systems such as Enterprise Resource Planning (ERP) software, Quality Management System (QMS), and Customer Relationship Management (CRM) software, among others. Integrating the LIMS with third-party data analysis tools can facilitate prompt downstream analysis and reporting that is instrumental for decision-making. Centralized data management will ensure consistency and make the data more actionable.

Leverage LIMS Reporting to Boost Your Lab Performance

You might have the best LIMS in the market, but if you fail to optimize it and make the data actionable, it will all be a waste. Making LIMS data actionable calls for several strategies. First, you need to understand the types of reports a LIMS generates and how and when to use each. You also need to understand how and when to set alerts. A LIMS dashboard can be configured to keep track of all the important parameters that should be within your reach at a glance. Lastly, make use of system interfacing to improve the performance of your LIMS and generate consolidated reports.

Originally published at https://freelims.org.

#LIMSReporting

[free-lims]

What is Delta-8 THC, & What Should You Know About it?

Delta-8 THC sales have peaked across various states, even though the legality of this Cannabis sativa-derived cannabinoid is controversial. That said, D8 products can be easily accessed online and have become quite popular among consumers who wish to enjoy some of the psychoactive effects of cannabis “legally”.

What exactly is delta-8, how different is it from delta-9-THC, and is it even legal in the first place? We shall be answering these questions in this blog.

What is Delta-8 THC?

Delta-8 THC is one of the hundreds of cannabinoids naturally produced in cannabis. It appears in very small doses, which is why processors must extract and concentrate it into oils, tinctures, and distillates, which are then transformed into edibles and other products.

Whereas THC is found abundantly in several cannabis strains, Delta-8 THC usually appears in very small amounts.

Structure of Delta-8 THC

Delta-8 is an isomer of the popular cannabinoid delta-9-THC. This means that the two share a similar chemical structure (C21H30O2); however, the structure differs in how the atoms are arranged. In the case of delta-8 and delta-9, both have a double bond which is located at different positions; the 8th and 9th carbon chains respectively. The difference in structure gives the two compounds distinct properties.

Is Delta-8 THC Intoxicating?

Yes, delta-8 THC is intoxicating; however, to a milder extent as compared to delta-9 THC. Some sources cite that it is about 50%-66% less potent. However, since hemp-derived delta-8 THC is considered legal, then delta-8 provides a way for consumers to get “legally high”.

Does Delta-8 THC Have Therapeutic Benefits?

Yes, delta-8 THC has therapeutic potential which is under investigation. So far, the usefulness of delta-8 THC in managing pain, nausea, and vomiting has emerged. A study in 1995 found that 100% of pediatric cancer patients treated with Delta-8 THC for relief of nausea during chemotherapy found relief.

Why is Delta-8 THC Popular?

Delta-8 THC binds to the endocannabinoid system in a similar fashion to THC and therefore induces many of the same effects. On a cognitive level, people who have consumed Delta-8 THC have reported a high that is similar to THC; however, one that is more clear-headed and energetic. This can be a great breakthrough for consumers who like the medicinal and psychoactive effects of THC but would also want to function with energy and clarity throughout the day.

Delta-8 THC is popular largely because of its psychoactive properties. Since it can be legally derived from hemp, it allows users to enjoy it recreationally without having to worry about breaking federal laws. However, most of the delta-8 products in the market are synthetically produced.

Is Delta-8 THC Legal in the US?

At the time of writing this blog, the legal status of Delta-8 THC is officially entering the gray zone with many states banning both its use and sale.

Delta-8 THC derived from hemp is legal as all hemp-derived products as per the 2018 Farm Bill are legal. Any Delta-8 THC derived from cannabis is considered a federally controlled substance. Another big problem with Delta-8 THC (apart from it being intoxicating) is that it is found in trace amounts in hemp, which prompts most of its production to be synthetic, i.e. gotten from chemically altering CBD to Delta-8 THC.

According to the DEA, “this squarely bundles Delta-8 THC into the illicit category.”

In the DEA interim final rule which was published on August 21, 2020, “All synthetically derived tetrahydrocannabinol remains schedule I controlled substances.”

Delta-8 THC is considered legal in most states other than Alaska, Arkansas, Colorado, Delaware, Idaho, Iowa, Louisiana, Montana, New York, North Dakota, Rhode Island, Vermont, and Utah where it is illegal.

Why is it Important to Test Delta-8 THC?

The FDA has raised concerns about the safety of delta-8 THC products that are on the market. The concerns have been based largely on mislabeled D8 products and those that contain harmful chemicals. This makes it very important to test delta-8 products to ascertain potency and purity.

How a Cannabis LIMS Supports Delta-8 Testing

A Laboratory Information Management System (LIMS) organizes and stores laboratory samples and associated data. It streamlines workflows in the lab and integrates instruments to ensure efficiency. Unlike traditional spreadsheets, a Cannabis LIMS can be configured to meet the data management, automation, and reporting needs of laboratories testing delta-8 THC. A cloud-based LIMS solution provides real-time access to lab data from anywhere, anytime, and provides numerous other benefits.

Conclusion

Delta-8 THC is a cannabinoid of interest to researchers looking to exploit the therapeutic potential as well as consumers looking to get “legally intoxicated”. However, due to its controversial legal status, the sale of delta-8 THC is highly regulated. Unfortunately, concerns have been raised about the safety of delta-8 products that are on the market. Accurate testing of delta-8 products is therefore recommended and a cannabis LIMS is necessary to support this process.

Originally published at https://freelims.org.

#Cannabislims #lims

[free-lims]

Advantages of Moving Your Lab Quality Management to the Cloud

Cloud computing is a revolutionary technology that allows computing services such as databases, software, intelligence, and analytics, to be delivered “in the cloud “ and by doing so, provides benefits such as real-time access, flexibility, and economies of scale.

Cloud computing enables laboratories to rent computing infrastructure and hence avoid incurring upfront costs of procuring expensive IT infrastructure and save on maintenance costs. It also allows laboratories to borrow and leverage technical expertise at minimal costs. Some cloud computing service providers ask their customers to only pay for what they use. At the same time, the companies offering cloud computing services can leverage economies of scale by providing the services to several customers and hence bring their costs down.

Importance of a Laboratory Quality Management System (QMS)

Quality management refers to the process of managing a lab’s tasks and other activities to ensure that quality standards are met. It involves creating policies and procedures as the building blocks for ensuring that quality standards are maintained.

Total quality management is a framework that involves the laboratory staff and management in the process of ensuring quality management. It aims at efficiency and consistency to drive continuous improvement.

A QMS helps laboratories track quality standards and hence results in efficiency, customer satisfaction, higher productivity, and compliance with regulatory requirements. A modern Laboratory Information Management System (LIMS) not only helps manage data but also streamlines the quality management operations of laboratories.

The Essentials of a Laboratory Quality Management System

Failure to implement a quality management system can result in catastrophic results for the laboratory. For example, failing to set standards for specimen storage could result in specimen mix-up, leading to wrong diagnosis and wrong treatment that may jeopardize a patient’s health and wellbeing. Therefore, it’s necessary to have a solid QMS in place.

Here are the essentials of a laboratory QMS:

1. Organization To ensure that quality standards are maintained, a lab needs to organize and direct all its activities toward the quality management system

2. Personnel Lab staff plays a key role in implementing the QMS. Therefore, they must be trained adequately and the training should be documented.

3. Equipment Lab equipment needs to meet the QMS standards. Dead or malfunctioning equipment needs to be documented and replaced.

4. Inventory Management Lab inventory items should only be purchased from suppliers that meet the set QMS standards. The inventory should also be utilized and stored appropriately.

5. Process Control This involves monitoring processes such as the collection and handling of samples and data to ensure that internal inefficiencies and errors are eliminated.

6. Information Management Laboratories handle a lot of information from patients, customers, and other stakeholders. This information needs to meet standards of accuracy, security, confidentiality, and accessibility. An information management system makes it easy.

7. Documentation and Record Keeping Documents such as SOPs and patient records are integral to the QMS process. They need to be available, accessible, accurate, and secure at all times.

8. Occurrence Management An “occurrence” refers to an error in the system that the QMS should be able to flag and investigate the cause in order to prevent a recurrence.

9. Assessment This is the process of comparing the lab’s quality standards against industry benchmarks. This can be done by lab management, auditors, or external inspectors.

10. Process Improvement A QMS should support continuous improvement components such as quality assurance, quality control, and Corrective and Preventive Actions (CAPA).

11. Customer Service The primary goal of the lab’s QMS is to enhance customer service and satisfaction. The needs and requirements of customers should therefore be prioritized in the QMS.

12. Safety Laboratories handle and process very sensitive information and consequently need to have safeguards in place at all times to ensure security. This includes physical security, IT security, and worker safety.

These are the important elements that make up a laboratory QMS. Are there any advantages of moving these elements to the cloud?

6 Benefits of Moving Lab Quality Management to the Cloud

Cloud computing has several advantages. Below, we have outlined some that cut across industries:

1. Provides Real-Time Access

Having your lab’s QMS in the cloud allows you to have remote data access at all times. This promotes collaboration, increases the speed of decision-making, and allows faster response to critical issues.

2. Lowers IT Costs Cloud computing allows labs to have access to the provider’s IT infrastructure and systems. This eliminates high startup and maintenance costs. Thus, cloud technology enables labs to reduce the Total Cost of Ownership (TCO) and maximize Return on Investment (ROI).

3. Enables Rapid Deployment and Implementation Cloud computing allows immediate deployment and implementation as the infrastructure is already available and ready. Upgrades can also be provided immediately at no extra cost to the lab.

4. Enables Agility Cloud computing provides agility not offered by a traditional LIMS. The latter relies on physical servers whose functionality is restricted to certain locations.

5. Automatic Software Updates Cloud computing offers automatic software updates which would otherwise be time-consuming and labor-intensive. This reduces operational vulnerabilities and inefficiencies.

6. Data Backup and Recovery Laboratories store huge amounts of sensitive data which need to be preserved. While remote storage is susceptible to damage, in-the-cloud storage supports data backup to different storage sites and hence ensures the safety of your data.

Cannabis testing laboratories are subject to very strict regulations that involve different stakeholders; growers, testing labs, and regulatory authorities. Cloud computing allows these labs to share information instantly with all the involved stakeholders. Clinical laboratories handle very sensitive information. Cloud computing enhances the security of this information.

Moving Your Lab Quality Management to the Cloud is a Win-Win

Cloud computing allows laboratories to minimize their IT costs while leveraging technical expertise from the provider. Laboratories can enjoy real-time access to their QMS, collaborate with other team members, and benefit from instant deployment and software upgrades. The QMS is also backed up and secure in the cloud. On the other hand, cloud computing providers enjoy economies of scale by providing this service to several laboratories. A modern cloud-based Laboratory Information Management System (LIMS) enables laboratories to not only manage data in the cloud but also streamline Quality Assurance/Quality Control (QA/QC) processes.

Originally published at https://freelims.org.

#LIMS

[free-lims]

Informed Consent for Clinical Research: Getting it Right From the Start

Clinical research helps determine the efficacy and risks of new medical products, drugs, and treatments on human beings. The most important aspect of research ethics is to respect the moral rights of research subjects to decide on research participation. Research participants are subjected to one or more health-related interventions such as drugs or surgical procedures to evaluate their effects on human health. However, it is essential that the subjects voluntarily participate in these trials. Furthermore, regulatory bodies such as the Institutional Review Boards (IRB) or Independent Ethics Committee (IEC) should ensure that the research is being conducted ethically without jeopardizing the rights, safety, and well-being of human subjects.

What is Informed Consent?

Informed consent is a written, signed, and dated form required when the research involves human beings, including patients, children, and healthy volunteers, and uses human genetic material, biological samples, or personal data. Ethical and valid consents indicate the voluntary participation of the subjects in clinical research. Informed consent should be written in an easy, understandable language and should be non-influential, unbiased, and coercion-free.

Informed consent for clinical research usually includes more information than the consent forms meant for standard treatments. It provides ongoing information to help subjects make an educated decision to participate in clinical trials.

Informed consent must provide all necessary information for the participant to make an informed decision. It should include the following details:

Research statement, purpose, and duration

A statement that the subject’s participation is voluntary and not compulsory

Procedures that will be a part of the trial

Potential benefits, risks, and discomfort of the research

Measures to ensure the safety and privacy of the Protected Health Information (PHI) of the subject

Information in case of procedural failure

The subject’s rights, for example, the subject can withdraw his/her consent for participation anytime

Contact information of the person who can solve the subject’s queries

Alternative procedures for treatments, if any

Importance of Informed Consent in Clinical Research

Clinical research facilities should receive signed informed consent from all participants involved in the research study. However, informed consent is more than just asking for participants’ permission. It also involves communicating with the researchers, doctors, and physicians to ensure that the participants understand all procedures involved in the study. Participants need to know that the research studies intend to test the safety and effectiveness of new medicines and treatments for the health and welfare of the public. They should understand that they are not patients but subjects when they become a part of the study. By communicating about the risks and benefits of the participation, subjects can make an informed decision regarding their participation without compromising their cultural, psychological, and social beliefs. Informed consent builds the trustworthiness of subjects for all stakeholders involved in the research. It also reduces the risk of possible legal actions and regulatory penalties.

How to Obtain Informed Consent?

There are two common ways to document informed consent; paper format and electronic format. Paper consent is collected by a research professional from the participant in person, whereas electronic consent (eConsent) is obtained electronically, scanned, and maintained digitally. Obtaining informed consent has always been difficult due to its sensitivity and complexity. Regulatory bodies governing clinical research have provided a few guidelines to obtain informed consent from research subjects. Some of them are mentioned below.

1. Competent subjects should personally decide and provide their consent for research participation.

2. Incompetent subjects need the consent of their legally acceptable representative (LAR), preferably guardians.

3. The potential subject should be aware of LAR’s consent, and any objection by the subject should not remain unnoticed.

4. The subject should be informed about the trial using simple language and small consecutive pieces of information.

5. An impartial witness should be a part of the informed consent discussion in case the subject or LAR could not read the written information.

6. If the subject wants his/her primary physician to be informed about the participation, the stakeholder should obey the subject’s decision.

7. Documents such as an informed consent document (ICD) that comprises a patient information sheet (PIS) and an informed consent form (ICF) should be provided before participation.

8. Researchers should conduct an interactive session with the subject to avoid any last-minute confusion.

9. Based on the understanding of the study, the subject signs the eICF confirming his/her voluntary participation in the study.

Exceptions to Informed Consent

There are a few exceptions to the ethics or general rule of obtaining informed consent. These are emergency research and therapeutic privilege. However, the subject still has the right to refuse to participate in the research study.

Emergency Research It is a situation where human subjects need emergency medical care, are not in a condition to provide their consent, and also do not have any LAR to represent them.

Therapeutic Privilege It is a situation where information disclosure is excused considering that disclosing the information would cause potential harm to the physical, mental, or social well-being of the participant.

Role of a Laboratory Software for Clinical Research Labs in Managing Informed Consent

Failure to obtain informed consent is a crucial issue in clinical research. A laboratory software for clinical research labs, also known as Laboratory Information Management System (LIMS), can help clinical research labs seamlessly manage subject data, demographic and clinical history of subjects, and informed consent to meet ethical and legal requirements. Moreover, it can help associate consent forms with the correct subject records and obtain consent electronically from participants.

Conclusion

Human subjects play a key role in clinical research. The unavailability of research subjects will prevent researchers from testing new drugs and treatments and may halt the advancement of biomedical research and the development of personalized medicine. Therefore, researchers should provide complete care to the participants and respect their decisions. Informed consent assures the integrity of researchers and motivates the voluntary participation of candidates. Digitization can minimize the risk of errors and help manage consent forms easily. A laboratory software for clinical research labs is an important tool to streamline clinical research, securely manage subject data, consent, and documents, and effectively drive clinical research.

Originally published at https://freelims.org.

#Clinical LIMS Systems

[free-lims]

Factors to Consider When Setting Up a Biobank

Biobanks collect and store a large number of biospecimens predominantly for health and medical research. The process is known as biobanking which includes everything from collection, preparation, preservation, analysis, and distribution of biological samples as well as associated data. The need to set up more biobanks has been increasing with the increasing demand for tissues and samples for biomedical research and translational studies. Biobanks must have documented standard operating procedures (SOPs) for all biobanking processes.

Are You Planning to Set Up a Biobank?

It is essential to understand the aim, funding, and scale of your project before setting up a biobank. You need to zero in on the type of biobank you want to set up. Following are some of the types of biobanks:

1. Disease-centric Biobanks: Disease-specific biobanks collect samples related to a specific disease.

2. Population-based Biobanks: These biobanks collect samples from the general population for use in broad-spectrum research.

3. Project-based Biobanks: These biobanks collect samples for a specific clinical trial.

4. Virtual Biobanks: These biobanks collect, store, and maintain sample data digitally and support transnational collaboration.

You can have a combination of all types depending on your needs.

Factors to Consider When Setting Up a Biobank

1. Sample Types

Biobanks need to securely process and store the collected samples to assure sample quality. Depending on the type of biobank you are planning to set up, you need to collect samples. To store fit-for-purpose samples, it is important that your samples meet the quality standards and have annotated metadata. Biobanks need to consider factors, such as sample transportation and sample preservation, based on the types of samples they collect and store.

2. Equipment

You need to purchase equipment based on the size of the biobank, your budget, the types of samples you need to process and store, and the available physical space of your biobank. A few common types of equipment needed in a biobank include:

Freezers: Select a freezer based on the type and expected number of samples you need to store. You can also customize the number of racks in the freezer based on your needs. Freezer gloves are another important thing to have.

Liquid Nitrogen Systems: These are needed if the samples need to be stored in liquid nitrogen for cryopreservation.

Generators: It is important to have backup power for freezers and other equipment in your biobank. You also need to have a sufficient number of uninterrupted power supplies (UPS) to commence an alternate power supply as soon as it goes off.

A biobank should always have surplus storage systems, racks, and storage boxes. It is also essential to monitor important parameters, such as temperature and humidity, by installing equipment monitoring systems. This is crucial to prevent deterioration in sample quality due to temperature fluctuations or abnormal humidity.

3. Physical Space

This is an important aspect of a biobank. You need a fairly large physical space as congested and poorly ventilated spaces are more prone to sample contamination. You may need to decide the exact area based on the space needed to accommodate freezers, generators, backup equipment, staff, and process samples.

4. Disinfectants

It is essential to maintain biological safety in your biobank. Biobanks need to follow standard guidelines for the disposal of bio-hazardous and non-hazardous waste. Depending on the samples you work with, you need to determine the level of biosafety and the type of disinfectants required. At your biobank, you must take all possible measures to prevent sample cross-contamination and should adopt a good disinfection method.

5. Contingency Plans

Contingency plans are emergency plans you must keep ready to fight potential hazards. It is important to identify the risks and effectively address them. You should conduct emergency response tests to assess the effectiveness of the emergency response. You must have a written agreement with reliable vendors for emergency delivery of resources. An emergency contact list of staff members and other stakeholders is a must for disaster management.

6. Governance, Budget, & Ethics

Your biobank should have well-trained staff to carry out day-to-day operations. A team of advisors, decision-makers, and administrators should be present among your staff members. You should estimate your expenses well to decide on the overall budget for setting up a biobank. You need to estimate the entire budget based on the cost of setup, products, services, and staff expenses. A biobank must comply with the ethical requirements of the country where it is located.

7. Accreditation

All commercial, third-party, or in-house biobanks need to follow regulatory guidelines and sample management best practices, such as ISO 20387:2018, EU GDPR, HIPAA, 21 CFR Part 11, and ISBER Best Practices to assure high-quality samples.

8. Software & Hardware

Digitization of biobanking operations is gaining popularity as it minimizes manual errors and increases efficiency. A laboratory software for biobanking, also known as Biobank Information Management System (BIMS) or biobanking LIMS, is crucial for automating workflows. It supports sample and data management while providing strong data security and donor privacy. You should select a BIMS that best meets your biobanking needs. A good laboratory software for biobanking should be able to securely manage samples and data, ensure data integrity by assigning role-based access to staff, meet compliance requirements, and remove data silos. Furthermore, a biobanking LIMS should be capable of securely managing patient data, documents and SOPs, maintaining a sample chain of custody, integrating with freezers and temperature monitoring systems, and scheduling staff training.

Hardware such as computers, laptops, printers, and hard drives, should be available for seamless data management.

Conclusion

Setting up a biobank requires a lot of thought processes and consideration of several factors. To meet the growing demand for high-quality samples and to comply with all operational and regulatory requirements, biobanks need a considerable amount of funding and resources such as equipment, staff, physical space, a laboratory software for biobanking, and hardware. You must contemplate all these factors before setting up a biobank so that the biobank fulfills the intended purposes.

Originally published at https://freelims.org.

#biobanking software

[free-lims]

Latest Trends in Clinical Diagnostics | Diagnostics Management System

Introduction

Clinical diagnostics are the mainstay for physicians to make decisions regarding disease treatment, management, and prevention. In-vitro diagnostics (IVDs) play a key role in the healthcare industry and have strongly contributed to controlling the spread of the SARS-CoV-2 virus. The clinical diagnostic industry has been rapidly trying to keep pace with the coronavirus and its emerging new mutants. Clinical diagnostic labs have been facing challenges such as ensuring the accuracy of test results, reducing the turnaround time, and securely delivering test reports to patients and physicians. Labs are adopting innovative techniques and new tests, upgrading their equipment, and implementing the latest software applications to manage a high volume of test requests, securely manage data, and meet reporting requirements.

In the wake of new emerging variants of the SARS-CoV-2 virus, the way forward for diagnostics is point-of-care testing, predictive healthcare, real-time testing, and leveraging Artificial Intelligence (AI) to predict disease outcomes and treatment regimes.

Challenges in Clinical Diagnostics

1. Variability in lab test results

2. Data silos that restrict the easy access and use of data across departments

3. The large number & variety of available tests complicates the selection of the correct test

How Can Digital Technologies Help?

The union of digital technologies and clinical diagnostics will help advance and improve patient experience and outcomes. At the same time, it will help improve the speed and efficiency of the testing process. Advances in omics and personalized medicine powered by automation technologies are shaping the future of clinical diagnostics. It will help improve performance, productivity, efficiency, and security without sacrificing reliability or accessibility.

Latest Trends in Clinical Diagnostics

1. Point-of-Care Testing

In point-of-care testing, the rapid testing of patients is performed at the ease of their homes. This facilitates quick diagnosis and enables physicians to commence the treatment of patients on time, preventing disease aggravation. It can also reduce the turnover time of results. Point-of-care testing simplifies the testing procedure and analysis. The results are stored in a secure digital environment, which can be accessed by healthcare providers and patients anytime and from anywhere.

2. Predictive Genetic Testing

Predictive genetic tests use tissue samples such as blood, hair, and skin to predict diseases and their future risks in humans. This provides substantial benefits as the treatment measures could be started well in advance. The information aggregated through big data and other sources can help healthcare companies develop healthy lifestyle recommendations for patients. Digitization and meaningful data support predictive analysis and better clinical decisions. Electronic medical records (EMRs) are the starting point for predictive analysis.

3. Diagnostics in Real-time

Wearables such as smartwatches and fitness bands collect a plethora of physical health information such as heart rate, blood pressure, body temperature, respiratory rate, blood oxygen level, and body motion. Compared to traditional diagnostic tests, real-time diagnostics help in improved and reliable decision-making since it collects more data points for effective decision-making. Their continuous monitoring ability provides instant feedback on a person’s well-being or health routine.

4. CDS Tools

Clinical decision support (CDS) tools can help transform clinical diagnostics. They help healthcare providers decide the steps in diagnosing or treating patients. CDS tools help analyze enormous amounts of digital diagnostic data and suggest treatment steps.

5. Lab Optimization Solutions

Clinical diagnostic labs continuously focus on reducing the number of unnecessary repetitive tests and adding more value to the necessary ones. Implementing robust business intelligence tools and analytics IT systems can quickly analyze a vast amount of test result data and find sources of unnecessary testing. This technology helps overcome test data overload by eliminating unneeded tests and improving value for necessary tests, saving resources and time in clinical diagnostic labs.

6. Artificial Intelligence (AI)

Artificial intelligence systems can help healthcare providers diagnose diseases based on medical images and data. AI is much more than what a digital transformation looks like in healthcare. Chatbots and virtual health assistants are a few known AI-based technologies. AI is well observed in precision medicine, medical imaging, drug discovery, and genomics. AI is gaining popularity throughout the healthcare system, from administrative and diagnostics to treatment.

Does Your Lab Support Digitization?

Many clinical labs, hospitals, and other healthcare organizations are migrating to cloud solutions to secure their storage and adopt new cloud-based applications. Secure cloud-based solutions, such as a Laboratory Information Management System (LIMS), also known as Clinical LIMS or diagnostics management system, make it easier to store records, manage data, transfer files between the staff, and enhance collaboration among staff. Furthermore, a diagnostics management system can be integrated with laboratory equipment and software, such as business intelligence tools, ERP, and CDS tools to support data interoperability and support decision-making.

Conclusion

Although the latest digital trends bring new opportunities for clinical diagnostics, they also present challenges, such as concerns regarding safety and data integrity of patients. However, the benefits outweigh the concerns. Digital trends in diagnostics can transform clinical diagnostics and make healthcare more accessible and affordable with improved outcomes. A diagnostics management system can digitally transform lab operations, support data interoperability, and enable labs to adapt to the latest trends to future-proof their operations.

Originally published at https://freelims.org.

#diagnostics management system