Clinical researchers gather information from sources such as medical records, administrative databases, laboratory tests, and others. The collected data is then processed, analyzed, and interpreted. Proper data management and analysis are essential for informed decision-making. Data-driven decisions enhance efficiency, accelerate the drug discovery process, and decrease operating costs. Data management has become a major challenge for clinical research laboratories due to data explosion in the past couple of decades. It becomes difficult to extract important and relevant data from the huge volumes of collected data without proper data management.

Data Explosion and its Causes

Data explosion is an exponential increase in the amount of data generated and stored digitally. The data deluge from various sources has left laboratories struggling with large and complicated volumes of information. Clinical research laboratories now study more diseases, traits, and conditions than ever before. The increasing number of clinical trials and studies has led to the continuous generation of increased amounts of data. Data can now be stored and shared at unprecedented levels, thus leading to data explosion. Rapid advances in technology such as the Internet of Things (IoT) also aggravate data overload. However, it is important to properly aggregate, identify, classify, and organize the data to get the most out of it.

Challenges

Clinical research laboratories need to manage diverse data such as sample data, patient data, data related to the clinical studies, and much more. Clinical researchers also need to combine large data sets, including clinical, genomics, biomedical, and omics data from multiple sources to make specific interpretations. They need to manage data in a way that they can draw accurate conclusions for improved decision-making. It becomes challenging for laboratories to manually manage and process such high volumes of data.

Importance of Data Sharing and Management

Data sharing in clinical research enhances collaboration and enables researchers to share their insights with each other, paving the way for more discoveries. Data sharing also brings transparency in the clinical research process, increasing public trust in clinical trials. Data sharing also improves the safety and effectiveness of therapies for patients and accelerates biomedical research. However, data sharing also brings in a few challenges. Clinical research laboratories need to ensure the protection of confidential clinical data and securely manage potentially large and heterogeneous datasets.

Clinical data supports drug discovery and helps identify novel biomarkers. It also helps provide personalized health care to patients. Clinical research laboratories need to manage all data without compromising its quality and security. Tools such as Electronic Health Records (EHRs) facilitate clinical research and support decision-making about the effectiveness of drugs and therapeutic strategies. Furthermore, it enables laboratories to optimize their operations, prevent data loss and redundancy, and ensure the seamless flow of data among all stakeholders.

How Can Technology Help?

Technology contributes a lot in seamlessly tackling data overload. The data is electronically stored, thus minimizing manual errors and enhancing data quality. It prevents clinical researchers from getting overwhelmed by the sheer quantity of the data. A Laboratory Information Management System (LIMS) can help clinical researchers overcome their day-to-day data overload and data management challenges. A laboratory software for clinical research, also known as a Clinical LIMS, can help in the following ways:

• Effectively manage clinical research samples and associated data.
• Standardize operations by automating laboratory workflows. Integrate with EHR to facilitate data interoperability and centrally manage, query, and analyze data.
• Integrate with statistical and data analysis tools for informed decision-making.
• Interface with laboratory instruments for secure data transfer, maintaining data integrity.
• Enable laboratories to meet reporting requirements with ease.
• Meet regulatory compliance such as HIPAA, EU GDPR, GCP, and 21 CFR Part 11 with ease.

Conclusion

Data overload interrupts seamless data flow among all stakeholders, thus slowing down the decision-making process. The increasing volume and complexity of data are posing challenges for clinical researchers as they tend to miss out on important information. Clinical research laboratories must have effective data management and automation solutions to overcome these challenges. A laboratory software for clinical research can help laboratories seamlessly manage, track, and securely share data with stakeholders, automate processes, and prevent data loss.

With the emergence of new SARS-CoV-2 mutants from time to time and the slow rate of vaccination in many parts of the world, COVID-19 testing laboratories may have to continue testing samples for many more years to come. COVID-19 diagnostic laboratories need to quickly turnaround samples and report accurate test results to enable quick decision-making for quarantine, isolation, and treatment of COVID-19 patients.

COVID-19 diagnostic laboratories should leverage modern technology for sample and data management and secure result delivery to patients and physicians. With a large number of samples coming in, COVID-19 testing laboratories should have a robust COVID-19 sample management system, also known as a COVID LIMS, to accelerate the testing throughput and meet the testing demand.

Following are some essential features to consider when deciding on a COVID LIMS for your laboratory:

1. Secure and Easy Access

A COVID LIMS should be easily accessible to all authorized staff involved in the laboratory process. It should be securely accessible on any device with an active internet connection irrespective of the physical location of staff. An ideal solution to fulfill these requirements is a cloud-based Laboratory Information Management System (LIMS).

A LIMS should be able to manage and securely store all kinds of Protected Health Information (PHI). A good LIMS should have the ability to protect the PHI of patients and healthcare providers by assigning role-based access rights to authorized staff. A LIMS should enforce two-factor authentication if anyone tries to access PHI to ensure foolproof security.

2. Patient Portal and Physician Portal

Several laboratories manage sample information manually using paper test request forms. However, the request forms are usually poorly written and are difficult for the laboratory staff to read clearly. This creates room for errors and delays testing. Furthermore, the laboratory staff may take days to deliver test reports to patients due to cumbersome manual processes.

A LIMS can automate the entire process, right from patient registration to report delivery. A COVID LIMS should have a secure patient portal to enable faster patient registration and secure delivery of test results.

How Does the Patient Portal Work?

Once a patient registers on the patient portal present on a laboratory’s website, the patient receives a QR code which can be scanned at the sample collection site to confirm the patient’s identity. Subsequently, the sample is collected, associated with the patient’s record, and sent to the laboratory for testing. As soon as the laboratory releases the test report, the patient can securely download it from the patient portal. The patient can have the digital test report scanned at airports or workplaces through a QR code, removing the hassle of carrying hard copies of the test report.

Physician Portal

A physician portal works similarly. A physician can also request a COVID-19 test for a patient from the physician portal and can access the test report in real-time as soon as it is released by the laboratory. This enables the physician to commence the treatment regimen without any delay.

3. Automated Sample, Data, and Result Management

A COVID LIMS should be able to record and store every data associated with all samples. Data collected and stored should always be associated with the correct sample. A LIMS should be capable of storing re-testing results along with the original test results if a sample was tested multiple times. A LIMS also enables laboratories to process samples and report results in a batch.

4. Instrument Integration

COVID-19 testing laboratories test a large number of specimens daily. They conduct different types of tests, such as RT-PCR and serological tests. It is inefficient for the laboratory staff to manually transfer the analytical data from instruments to a LIMS as it is error-prone and time-consuming. A LIMS should be configurable to support varied test methods. Furthermore, a LIMS should facilitate integration with diagnostic instruments, such as RT-PCR machines, for bi-directional data transfer. This automated data transfer process ensures data integrity and reduces the test turnaround time.

5. Formula Configuration

A LIMS should support the configuration of complex formulas for calculating final test results. Once the results are imported in a LIMS from diagnostic instruments, the LIMS should be able to quickly determine the final test results based on the results of control samples, test samples, and preset formulas.

6. Integration with Public Health Department Systems

All CLIA certified COVID-19 testing laboratories need to share the final test results with the appropriate state or local Department of Public Health (DPH), irrespective of whether the test results are positive or negative. Laboratories that report results directly to the Centers for Disease Control and Prevention (CDC) should continue sending test results to the CDC. A LIMS can help laboratories share this data with DPH in a requested time frame and required format. A LIMS should support integration with the DPH systems to securely send the final test results to the appropriate public health department.

7. Regulatory Compliance Support

COVID-19 testing laboratories face challenges in meeting regulatory requirements such as CLIA, ISO 15189:2012, HIPAA, GCP, and EU GDPR. A LIMS should enable testing laboratories to meet all these requirements with ease. A LIMS should be able to streamline quality control (QA) and quality assurance (QC) processes in a laboratory. It should be capable of managing training and competency records of laboratory personnel and monitoring their performance. Monitoring staff training can help laboratory managers assign COVID-19 tests to personnel with the appropriate skills, experience, and knowledge of biosafety protocols.

A good COVID LIMS should be capable of managing all laboratory documents, including standard operating procedures (SOPs) for standardized laboratory workflows. A LIMS should also be able to maintain the confidentiality of important documents by allowing role-based access to authorized personnel. A COVID LIMS should help laboratory managers manage all laboratory instruments, schedule calibration and maintenance of instruments to prevent analytical errors.

Conclusion

COVID-19 testing laboratories have been playing a critical role in controlling COVID-19 right from the onset of the pandemic. All COVID-19 testing laboratories need to quickly test samples and report results. COVID-19 testing laboratories face many operational challenges on a day-to-day basis. It is challenging for laboratories to manage a large number of specimens and associated data, generate test reports in a batch, manage patient records, record laboratory activities, safeguard the PHI of patients, manage documents, instruments, and staff training records, and meet compliance. A COVID-19 LIMS should have all the essential features listed above to enable laboratories to manage data seamlessly and automate processes, thus preventing manual errors. Furthermore, a LIMS system should enable laboratories to meet their regulatory and reporting requirements. By leveraging a COVID-19 sample management system, COVID-19 testing laboratories can reduce the test turnaround time and assure the accuracy of test results.

Water is essential for all aspects of life. Freshwater is important for human consumption, daily household activities, agriculture, and industrial activities. Billions of people across the globe do not have access to safe drinking water. Contaminated water gives rise to various waterborne diseases and jeopardizes public health. Chemical industries and agricultural practices are the major sources of water contamination. Water may contain inorganic, organic, biological, and radiological contaminants. Water testing laboratories play a crucial role in the qualitative and quantitative analysis of drinking water. They must be capable of detecting a myriad of contaminants in drinking water.

Common Water Contaminants in Drinking Water

The chemical properties of water govern its quality. The presence of contaminants in water can make it highly hazardous for consumption. Some of the common contaminants present in drinking water are as follows:

1. Arsenic: The presence of arsenic in drinking water is known to cause cancer in human beings. Apart from various types of cancers, including lung and skin cancers, arsenic is also known to cause health effects such as hyperkeratosis, peripheral vascular diseases, and digestive problems.
2. Fluoride: High fluoride concentration in drinking water causes dental issues, such as dental fluorosis and mottling of teeth. A high concentration of fluorides can also lead to skeletal fluorosis, increasing the risk of fractures. As per the U.S. Environmental Protection Agency (EPA), the maximum concentration of fluoride in drinking water should not exceed 4.0 mg/L.
3. Selenium and Uranium: The consumption of excessive selenium can lead to physical health issues such as loss of hair and weak nails. It also causes changes in peripheral nerves. Uranium is found in groundwater and tends to cause kidney diseases.
4. Nitrates: Nitrates in water are the result of agricultural waste that is released into the water. The presence of nitrates in drinking water is more harmful to children and infants. It can lead to methemoglobinemia in children. Methemoglobinemia is a fatal disorder that results in low blood oxygen levels.
5. Perfluorooctanoic Acid (PFOA) and perfluorooctanesulfonic (PFOS) Acid: These are man-made chemicals commonly used in the manufacturing of products, such as paper, paints, and electronics. Manufacturing industries release their industrial waste into the water, disturbing the environmental balance. The presence of these acids in water can cause diseases such as cancer, liver and immune effects.

Other metals that are known to be harmful, if present above the permissible limit in drinking water, are aluminum, iron, copper, and cadmium.

Organic contaminants, such as pesticides, volatile organic compounds (VOCs), and dyes, are harmful to the environment as well as human health. Exposure to unsafe levels of these contaminants may lead to cancer, nervous system disorders, and kidney diseases in humans.

Biological contaminants such as bacteria and microorganisms are naturally present in water. Some common harmful bacteria present in untreated drinking water are E. coli and Legionella pneumophila. Microorganisms, such as Cryptosporidium and protozoa, are also commonly known to cause severe health issues such as diarrhea, stomach cramps, nausea, fatigue, dehydration, and headaches in infants and adults.

The presence of radioactive materials in water usually originates from industrial waste and can cause harmful diseases, such as cancer.

Role of Water Testing Laboratories

Water testing laboratories assure the quality of drinking water through accurate and reliable testing of water samples. However, they face numerous challenges on a day-to-day basis. This includes managing a large number of samples and tests, automating workflows, reducing the turnaround time, and meeting regulatory requirements. Water testing laboratories need a robust data and quality management system to overcome the operational challenges and follow regulatory requirements, such as NELAP, ISO/IEC 17025:2017.

A Laboratory Information Management System (LIMS) helps assure the reliability and quality of test results. A LIMS helps manage samples and test results, streamline QA/QC processes and digitize operational workflows. A LIMS maintains a sample chain of custody and a read-only audit trail which is required during audits. A water LIMS flags out-of-specification test results if a sample exceeds regulatory limits of various contaminants. It helps generate certificates of analysis (CoAs) as per customers’ and regulatory requirements.

Conclusion

The drinking water should be free from contaminants and microorganisms for public safety. Both developed and developing countries have increased agricultural and industrial activities for economic development. However, this is affecting the quality of water and posing risks to public health. Contaminants in drinking water are harmful to the health and well-being of people. Not only it affects health, but also it disturbs the environmental balance. The onus of public safety lies with water testing laboratories. Water testing laboratories should generate accurate and valid test results to flag contaminated water samples. Laboratories must deploy a robust water LIMS to automate their processes and meet quality standards. A LIMS enables water testing laboratories to overcome operational roadblocks, meet regulatory requirements, and amplify productivity.

Biospecimen acquisition in industry represents a serious challenge that slows down innovation. The number of biobanks has increased around the world due to the growing requirement of biospecimens by industry. However, the lack of connection between biobanks and industry has slowed down the possibilities to use biospecimens for testing new therapies, developing vaccines and strategies for diagnosis. Private companies face difficulties accessing high-quality specimens because they mostly originate from public sector healthcare facilities and companies have limited access to such facilities. It is important to bridge the gap between biobanks and industry so that researchers can easily access carefully processed, high-quality biospecimens to support research and development.

Pharma and biotech companies mainly procure biospecimens for research from commercial brokers who charge a fee for providing samples from biobanks. However, the use of intermediaries leads to uncertainty about sample quality and adequacy for the required experiments. Big pharma companies manage to procure samples from hospitals and in-house biobanks. They also conduct clinical trials which give them access to hospitals, doctors, and patients. Access to biosamples becomes more complicated for small biotech companies as they find it harder to establish collaborations with hospitals and biobank networks.

Challenges Faced by Industry in Obtaining Quality Samples

Commercial brokers are apprehensive about the direct interaction between a researcher and the biobank as this could lead to a loss of profits. Due to this, brokers usually do not prefer to disclose the sample source. Unfortunately, this leads to a lack of provenance information such as sample processing history, donor information and medical history, and geographic origin of samples.

Researchers need to know the identity of the source biobank. The source biobank should have obtained the appropriate license and certification as it assures sample quality and reliability. Knowing the geographic origin of samples is also important to understand the environmental, socio-economic, and genetic factors of samples. Biobanks should maintain donors’ consent for all samples stored in their biobanks and must have standard operating procedures (SOPs) in place for procuring, processing, and distributing samples. It also helps prevent the use of illegally sourced samples. Obtaining biospecimens internationally also poses a challenge of miscommunication between the source and the end-user.

Solutions

To overcome such challenges, commercial brokers can allow direct communication between the source biobanks and end-users with an agreement to ensure brokers’ commission. Companies can build their networks of biobanks to supply them with the required biospecimens. However, it is challenging to find suitable biobanks with the necessary samples in stock. Therefore, many small to medium-sized biotechs end up obtaining samples from unreliable brokers, compromising the quality and reliability of samples.

The direct connection between biobanks and industry represents a great opportunity for both sectors. Some proposals to address the challenges outlined above are:

• Promote regulations that protect the ethical usage of biospecimens while allowing biobanks to charge a fee for sample processing.
• Establish high standards for biosamples collection, processing and storage, with adequate documentation and data provenance to assure sample reliability.
• Promote patients’ approval to participate in private sector research by educating them about the importance of biotech and pharma health innovations.
• Encourage industry to procure samples from biobanks that meet regulatory compliance and best practices, such as ISO 20387:2018, EU GDPR, HIPAA, and ISBER Best Practices, and follow pre-defined SOPs to maintain quality standards.

A commercial biobank can play an important role in overcoming the sample supply deficit. Commercial biobanks are experienced in interacting with industry and meeting their requirements. Unlike academic biobanks, commercial biobanks act quickly to meet administrative and regulatory requirements to provide samples to companies to facilitate their research.

How a Biospecimen Management System Can Help Biobanks Maintain Data Provenance & Maintain High-quality Samples

Companies can rely on biobanks that use a Laboratory Information Management System (LIMS) for managing data and standardizing their operations. A LIMS effectively manages samples and associated data to facilitate their tracking through sample acquisition, collection, preparation, storage, testing, analysis, and distribution. It helps in safeguarding data by assigning role-based, secure data access to authorized users. A biospecimen management system, also known as a biobanking LIMS, helps biobanks manage sample genealogy, track sample locations, and manage the shipment of samples when working with collaborators. It maintains a chain of custody to regulate the internal or external transfer of biospecimens from one custodian to another.

A biospecimen management system manages standard operating procedures (SOPs) and controls access to confidential documents, thus ensuring data security. It records details such as training details, qualifications, and competency of each staff involved in biobanking activities. Furthermore, a LIMS helps biobanks follow regulatory guidelines such as ISO 20387, HIPAA, EU GDPR, and 21 CFR Part 11.

A LIMS enables commercial biobanks to publish their sample collections along with detailed sample information on a personalized web catalog. Researchers from industry can easily find samples of their interest on the web catalog, place an order for the samples they need, and track the status of their requests.

Conclusion

Biobanks are responsible for providing high-quality, well-documented biosamples to industry to facilitate the development of new drugs, therapies, and diagnostic products for improving patient care. Pharmaceutical and biotech companies should procure biospecimens from biobanks that maintain strict quality and ethical standards and provide reliable data provenance information. A biospecimen management system is a secure and reliable system for collecting, storing, processing, analyzing, and reporting all types of biobank data. It helps biobanks securely manage data, streamline workflows, comply with regulations, and follow sample management best practices.

Food fraud has become a major concern for food manufacturers due to an increasingly globalized food supply chain. Public health is under high threat due to food fraud in the supply chain. Apart from public health, food fraud adversely impacts consumers’ faith in the food industry and government agencies. Food safety authorities around the globe are working to ensure food safety; however, blind spots in food supply chains provide likelihoods for individuals and firms to conduct food fraud.

Food fraud has been rising mainly because of the numerous steps involved in the supply chain, lack of clarity of the origin of the ingredients, insufficient or incomplete audit process, absence of traceability information, and lack of accurate analytical data. Most countries or regions are not prepared to fight food fraud because manufacturers’ management systems are not effectively ready to detect alterations in food. It is primarily because the reviews of quality control are performed only at the documentation level or because there are gaps in the vulnerability assessment or even the lack of it.

The lack of upstream supply chain visibility is another challenge faced by food brands. Food brands generally use one-up, one-down traceability; however, it does not keep track of all suppliers involved in manufacturing a specific food item.

Consumers are concerned about what they are eating and if they are getting what they pay for. Many NGOs, policymakers, and other groups are also putting more and more pressure on food brands to improve food integrity and safeguard the overall food supply chain. Government regulations, severe sanctions, and reputed suppliers can efficiently reduce the risk of food fraud. However, this is not enough to systematically detect and prevent potential fraud.

Types of Food Fraud

Some common types of food fraud are as follows:

• Adulteration: It refers to the inclusion of an ingredient or a substance in a food product that is not mentioned on the product’s label to incorrectly represent the product’s quality, safety, or origin.
• Tampering: It refers to the fraudulent use of legal food products and their packaging.
• Overrun: It refers to the production of legitimate products in surplus quantities that are not reported.
• Theft: It refers to obtaining food products illegally or dishonestly to gain profit.
• Waste Diversion: It refers to diverting waste food products back into the supply chain, jeopardizing public safety.
• Simulation: It refers to the manufacturing of illegal food products that look similar to legitimate products.
• Substitution: It refers to replacing a food ingredient with a substance of inferior quality.

How to Prevent Food Fraud?

Food crime can be an individual act of dishonesty or illegal activities by a criminal network. Advanced laboratory techniques are important to identify adulteration in ingredients and final food products. Analytical techniques such as rapid PCR testing, gas chromatography, and mass spectrometry can help identify adulteration of food products. High performance and hyphenated techniques, such as UHPLC-MS/MS, ICP-MS, LC-ICP-MS enable simultaneous detection of several adulterants in the level of parts per billion (ppb).

Food manufacturers need to implement a traceability system to identify and track every product from farm to fork. Food brands need to monitor the complete supply chain in real-time. A foolproof traceability system can provide food manufacturers with data-driven insights into a product’s history. This can help food manufacturers take quick actions against potential food fraud and guarantee food safety and authenticity. Laboratory software for the food and beverage industry can help food brands detect problems in the production cycle and notify concerned persons. Hence, corrective actions can be taken to prevent potentially contaminated products from being released to the market. Food brands need more reliable data, improved data analysis, new tools and technologies, and a greater understanding of the underlying scientific, economic, and cultural issues that drive food fraud.

Role of a LIMS in Fighting Food Fraud

A Laboratory Information Management System (LIMS) serves as a strategic defense against possible food fraud. Adopting a proactive monitoring approach of the products along the supply chain, together with the structure and consistency that a LIMS offers, helps ensure data integrity and the appropriate tracking of samples. A laboratory software for the food and beverage industry, also known as a Food and Beverage LIMS or Food LIMS, helps generate trustworthy results, maintain transparency in test methods, ensure end-to-end traceability, and help map every stage of the process in the supply chain. With the constant threat of adulterated foods in the market, it is imperative to have a LIMS that assures a high level of data integrity for the analysis performed in a laboratory. A LIMS helps identify potential hazards at specific points in the supply chain and supports strategic vulnerability-based decision-making.

A Food LIMS automates daily laboratory processes and workflows. A LIMS helps in managing QA/QC processes and recording associated data. It also helps flag out-of-specification results so that timely actions can be initiated. The results of the QC samples can be compared with the test samples to identify analytical errors. A laboratory software for the food and beverage industry can help track all activities along with a date and time stamp. A LIMS helps manage important laboratory documents, such as manuals, standard operating procedures (SOPs). It helps in scheduling staff training and maintaining their competency records. Furthermore, laboratory software helps food testing laboratories meet compliance, such as ISO/IEC 17025:2017, FSMA, HACCP, and assure food safety at all times.

Conclusion

The food industry is under constant pressure to keep prices down due to increasing globalized food supply chains and the economic motivation to provide cheaper food products. Food manufacturers need to have proper vigilance through the supply chain to ensure food quality and consumer safety. Food testing laboratories perform several tests on food products to detect foreign materials. They should digitize the testing process to ensure the safety and quality of products. A LIMS can play a key role in fraud detection and prevention. It helps in maximizing the efficiency of laboratories and enables them to provide accurate and reliable test results. The manufacturers must create tailored strategies to reassure the customers that the food they get from the shelves is safe for consumption.

What is Data Provenance?

Data provenance, also known as data lineage, refers to tracking the origin of data and continuous changes in data with time. Data provenance helps in tracking errors within data and finding sources of such errors. Furthermore, maintaining data provenance is essential for clinical laboratories if they are preparing for audits. Data provenance in a clinical diagnostic laboratory should commence from the time a sample enters the laboratory until the test results are reported.

Importance of Data Provenance

Clinical diagnostic laboratories generate and store massive amounts of data daily. Many laboratories still use traditional documentation methods to manage and record data. They still practice taking instrument readings manually and maintaining handwritten notes. These notes are then transcribed into excel sheets, thus leading to transcription errors. Moreover, manual procedures of data management reduce data interoperability, leading to data silos. Laboratory professionals also practice double data entry to catch and minimize errors but end up losing significant time and effort. Digital transformation is essential for laboratories to overcome these challenges and reinforce data provenance.

The digitization of processes and data management techniques is paramount for tracking provenance and eliminating data silos. Modern laboratories ensure that all steps of diagnostic processes are documented digitally so that they can track and manage all data using a single system. This helps them streamline workflows, meet compliance standards, and strengthen data provenance. Data provenance provides a cohesive understanding of the role of all staff members in a laboratory. When data is recorded electronically, it becomes easy to track its origin, share data and test results with colleagues, reducing the turnaround time. Furthermore, any changes in data can be easily updated and recorded for future use if maintained digitally.

Why Should Clinical Diagnostic Laboratories Prioritize Data Provenance?

Clinical diagnostic laboratories must securely manage sensitive patient data and laboratory records. This helps laboratories meet regulatory requirements, such as CLIA, HIPAA, ISO 15189. Data provenance also aids in interpreting data and tracing back the test results to samples and associated patients. Data provenance supports the reproducibility of laboratory findings by providing all the necessary data and associated metadata as and when required. The efficiency of laboratory processes and performance of laboratory staff can also be examined, providing an area for improvement in case of any deviations from set standards.

How Does a Clinical LIMS System Support Data Provenance?

A Laboratory Information Management System (LIMS) can help clinical diagnostic laboratories maintain data provenance in the following ways:

1. Assign role-based patient data access to authorized personnel only to safeguard Protected Health Information (PHI) of patients.
2. Track all laboratory activities along with a date and time stamp by maintaining a read-only audit trail.
3. Manage documents, such as procedure manuals, instrument maintenance manuals, and ensure document control.
4. Manage all patient data, including demographic details, patient consent, and patients’ medical history.
5. Store annotated sample data and track samples using barcodes and print labels.
6. Manage all aspects of sample genealogy. It also helps maintain a sample chain of custody (CoC) and access a complete history of each sample from accessioning to the final disposal.
7. Support instrument integration for the effective management of growing data volumes. Instrument integration also helps eliminate chances of transcription errors, data redundancy and also assures data integrity.
8. Ensure automated workflow management and track deviations from standard workflows.

Conclusion

Data provenance helps laboratories record the origin of data throughout the sample lifecycle. It helps laboratories understand the relevancy of data. Data provenance puts an end to functional laboratory silos and helps track and manage data in all steps of laboratory processes. Clinical diagnostic laboratories should create a foundation for strong provenance and ensure complete data traceability.

Data provenance helps modern laboratories streamline workflows and comply with regulations. Diagnostic laboratories must implement a secure and reliable data management system for collecting, storing, processing, analyzing, and reporting all data. A clinical LIMS system streamlines existing processes and facilitates data recovery even after years of diagnosis.

An internal audit is a kind of self-assessment conducted to identify critical issues and helps determine the effectiveness of a laboratory’s risk management capabilities. Internal audits provide insights into a laboratory’s culture, operations, and compliance with applicable laws and regulations. The data is precisely analyzed in internal audits to provide recommendations for improvement.

It is essential to conduct an internal audit if your laboratory is preparing for a third-party audit. An internal audit is instrumental in identifying operational gaps, thereby minimizing the chances of failure. An internal audit provides you an opportunity to check audit preparations before an external assessor arrives at your facility. An internal auditor, or an auditing team, should conduct an audit impartially, keeping in mind the requirements of an external audit. Conducting an internal audit also makes laboratory managers more mindful of the loopholes that an external auditor may identify, enabling laboratories to work on the areas of improvement.

Few benefits of internal audits for cannabis and hemp testing laboratories are as follows:

• Ensure compliance with industry standards, statutory and regulatory requirements, such as ISO 17025:2017, 21 CFR part 11, GLP, and state and local regulations.
• Prevent expensive mistakes and improve operational efficiency.
• Determine if the QA/QC processes implemented are effective in generating accurate and repeatable results.
• Be better prepared to answer the questions of external auditors and face them with confidence.
• Determine the effectiveness of the quality management system in place.
• Determine if laboratory staff members follow pre-defined standard operating procedures (SOPs).

An internal audit is typically done under a CAPA (Corrective and Preventive Actions) program. CAPA is a part of the quality management system which controls and detects errors in laboratory processes so that corrective measures can be taken to prevent their recurrence. The CAPA program enables you to thoroughly investigate and determine the root cause of potential issues. It allows you to record customer complaints and aids in continuous improvement. An effective CAPA program enables laboratories to pinpoint the factors responsible for cross-contamination, such as improper environmental controls, poorly designed laboratory infrastructure. High-quality laboratory supplies are imperative for generating accurate test results. A CAPA program enables cannabis testing laboratories to monitor the performance of suppliers to determine if they are consistently meeting the specified requirements. Ideally, cannabis testing laboratories should procure supplies from vendors certified to specific standards.

Role of a Cannabis LIMS in Internal Audits

A LIMS for cannabis and hemp testing helps ensure data accuracy and integrity, compliance with regulatory requirements, efficient data management and analysis, and risk management. These benefits can help internal auditors perform their audits effectively and efficiently, and identify areas where improvements may be needed. A laboratory information management system (LIMS) facilitates not only external audits but also internal audits. A LIMS maintains a read-only audit trail to track all laboratory activities along with a date and time stamp and other details, such as who made the change, the reason for making the change. A LIMS maintains ongoing training and competency records of analysts and helps assign analytical tasks only to the competent staff, assuring the accuracy of test results. A LIMS enables cannabis testing laboratories to record customers’ complaints and corrective and preventive actions taken for non-conforming activities. A LIMS automates enforcement of SOPs, maintains a decisive chain-of-custody to track sample custodians through the sample lifecycle, and manages suppliers and laboratory inventory. A LIMS manages all internal and external documents such as validated standard test methods, drawings, manuals and ensures version control. A Cannabis LIMS ensures timely calibration and maintenance of instruments, records calibration results, and flags instruments that are unsuitable for analysis. Furthermore, a LIMS automates laboratory processes to reduce human errors and flags samples that fail testing.

Conclusion

Cannabis testing laboratories should plan and conduct internal audits from time to time to identify potential drawbacks in their operational workflows. Internal audits are time-consuming and resource-intensive, however; they offer innumerable benefits. A successful internal audit ensures standardization of processes and increases the chances of surviving external audits. To prepare your cannabis testing laboratory for an external or third-party audit, you should prepare an audit checklist and conduct an internal audit to understand if there are any gaps between your current processes and the requirements of the standard, such as ISO/IEC 17025:2017. Cannabis testing laboratories should implement automated systems, such as a LIMS, to digitally manage samples, test results, SOPs, staff training records, certificates of analysis (CoAs) and increase operational transparency. A Cannabis LIMS saves significant time and minimizes transcription errors. A successful audit calls for effective preparation, a good quality management system, trained laboratory personnel, and foolproof processes.

The study of diseases has greatly evolved over the years as more information can be collected from samples obtained from groups comprising tens, hundreds, or even thousands of subjects. Body fluids or tissues (such as blood or biopsies) can be collected from these donors along with other information such as demographic information and medical history. Thus, there is a need for repositories such as biobanks that can store and manage samples derived from patients as well as healthy donors.

What are Biobanks?

Biobanks are repositories that store biological samples and associated metadata for human research. The process of collecting, storing, and maintaining these samples obtained from patients and healthy donors is known as biobanking. Samples may need to be stored securely for several years for present and future research. Establishing a biobank requires careful control of various steps such as sample collection, processing, storage, and transportation. Therefore, preserving sample quality and integrity is essential, which necessitates rigorous quality control within a biobank to meet present and future needs.

Tips to Maintain Sample Quality

Samples may be required to be used several times, either for a specific study or entirely different projects. Before using a sample, it has to be taken out of freezers and thawed before use. However, repeated freeze-thaw cycles might degrade sample quality and consequently deteriorate the outcome of the research. Thus, the same sample must not be subjected to multiple freeze-thaw cycles. A solution for this is to fractionate samples in small volumes for single use. In this way, a fraction can be used for specific research, while the remaining sample can remain in storage until needed. Consequently, biobanks are required to maintain a log of the number and quantity of samples and aliquots available and record any freeze-thaw cycles.

Adequate storage at temperatures below –80 ºC is essential to maintain sample integrity. Ultra-low temperature freezers are used to store samples for several months. For long-term preservation, lower temperatures (< –150 ºC) are needed; thus, containers with vapor-phase liquid nitrogen must be employed. Samples can be stored in liquid nitrogen for years, but the containers must be routinely checked. Records of maintenance services indicating when nitrogen tanks were refilled or if there were any malfunctions should be maintained.

To maintain the integrity of biological samples, they should be frozen and recovered using automated systems. Manual systems are usually labor-intensive, which makes them prone to human errors. Moreover, fluctuations in temperature can have detrimental effects on biological samples. When storing a large number of samples, the use of heat-sealed tubes provides better storage because they offer easier handling and high sample integrity at low temperatures than screw caps. There are automated systems that can uniformly seal these tubes, eliminating errors arising from manual screwing. Additionally, proper labeling of samples is essential for their seamless tracking.

Role of a Biobanking LIMS in Maintaining Sample Quality & Integrity

A biobanking LIMS, also known as a biospecimen management system, helps biobanks securely manage all the required sample information to facilitate research. It tracks freeze-thaw cycles, maintains a record of the storage temperature of each sample, and generates custom sample and storage reports. It also helps manage donor data, consent and anonymizes protected health information of donors to safeguard their privacy. It helps locate stored samples, generates sample labels, and ensures sample integrity by standardizing biobanking workflows.

A biospecimen management system can be integrated with temperature monitoring systems to monitor the temperature inside and outside freezers. Furthermore, it raises an alarm if the storage temperature falls below the optimal temperature. A LIMS also helps follow biobanking regulatory guidelines and best practices, such as ISO 20387:2018, EU GDPR, HIPAA, 21 CFR Part 11, ISBER, and NCI Best Practices.

Conclusion

The emerging demand for personalized medicine creates a need to collect more and more samples and gather specific data. Biobanks are responsible for managing a large amount of annotated sample data and for providing high-quality samples to researchers for clinical trials, cohort studies, drug discovery, and research on life-threatening diseases, such as cancer and heart diseases. Biobanks face numerous operational, data management, and regulatory challenges on a daily basis. A biospecimen management system helps maintain sample quality by managing the complete history of each sample from accessioning to disposal. It enhances operational efficiency and enables biobanks to follow sample management best practices. It also helps biobanks follow regulatory guidelines with ease, automate workflows, eliminate data silos, ensure data security and sample integrity.

The evolution of highly transmissible SARS-CoV-2 variants has concerned health officials worldwide. It is important to accelerate the vaccination rollout to prevent the spread of SARS-CoV-2 and reduce the rate of viral mutations. The new variants of SARS-CoV-2 may affect the accuracy of COVID-19 test results, however, with an unknown degree of impact. With the emergence of SARS-CoV-2 variants, COVID-19 diagnostic laboratories need to adapt to new assays to ensure accurate reporting of test results.

SARS-CoV-2 Variants and Their Origin

SARS-CoV-2 constantly evolves through mutation, with new variants emerging with time. Although numerous SARS-CoV-2 variants have been detected, only four variants are of public health concern because they are highly transmissible, cause more severe illness, and elude the immune system. These four SARS-CoV-2 variants are listed in the table below.

Variant Type	Pango Lineages	Country of Origin
Alpha	B.1.1.7	United Kingdom
Beta	B.1.351 B.1.351.2 B.1.351.3	South Africa
Gamma	P.1 P.1.1 P.1.2	Brazil
Delta	B.1.617.2 AY.1 AY.2 AY.3	India

Apart from the variants of concern mentioned above, the following new variants are of interest according to the World Health Organization (WHO).

SARS-CoV-2 Variant Type	Pango Lineages	Country of Origin
Eta	B.1.525	Multiple countries
Iota	B.1.526	United States of America
Kappa	B.1.617.1	India
Lambda	C.37	Peru

Which Molecular Tests are Affected by SARS-CoV-2 Viral Mutations?

A COVID-19 test may produce a false-negative result if a part of the SARS-CoV-2 genome that is targeted by RT-PCR tests is mutated. The Food and Drug Administration (FDA) has identified the following tests that could be impacted by new SARS-CoV-2 viral mutations:

1. Accula SARS-CoV-2 Test (Mesa Biotech Inc.)
2. Linea COVID-19 Assay (Applied DNA Sciences, Inc.)
3. TaqPath COVID-19 Assay (Thermo Fisher Scientific, Inc.)
4. Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2 (Cepheid)

The presence of viral mutations tends to reduce the sensitivity of these tests. Diagnostic tests that leverage a single genetic target of SARS-CoV-2 are more likely to be impacted by variants. Contrarily, tests that detect multiple genetic targets of SARS-CoV-2 are more foolproof and are less likely to be impacted by variants.

How COVID-19 Testing Laboratories can Address the Challenges Posed by SARS-CoV-2 Variants

Continuously emerging variants of SARS-CoV-2 are likely to affect the current diagnostic tests. Laboratories must adopt new methods to overcome the risk of reporting false negatives. As the pandemic continues, there is a possibility of further genetic changes in the genome of SARS-CoV-2 that may significantly impact the accuracy of COVID-19 tests. Hence, COVID-19 testing laboratories should support new assays and test methods that can detect SARS-CoV-2 variants.

Laboratories should perform in silico analysis of the primer binding to assess the impact of new variants on current RT-PCR tests. Laboratories can also implement a screening process for the identification of emerging SARS-CoV-2 variants. For this, they need to work coherently with public health authorities and genome sequencing surveillance networks. Laboratories conducting genome sequencing-based assays may consider including variant monitoring in their routine quality assessment program to identify new variants. Whole-genome sequencing should be done for patients with prolonged COVID-19 positivity to monitor new emerging variants.

Role of a COVID-19 Laboratory Management Software

A COVID-19 LIMS supports testing workflows, assays and also generates custom test reports that comply with FDA, CDC, and local reporting guidelines. A LIMS also aids in the validation of new methods for COVID-19 testing. A configurable LIMS helps in complex data management, workflow automation and minimizes operational errors. Furthermore, a configurable COVID-19 laboratory management software enables COVID-19 testing laboratories to accommodate new workflows or update existing workflows to easily adapt to new assays.

Conclusion

The quick spread of COVID-19 has threatened public health and the economy and demands advanced strategies to arrest the spread of COVID-19. Scientists are progressively developing antiviral therapies and vaccines to fight the virus. It is necessary to identify new emerging variants to prevent inaccurate reporting of test results that may undermine the current efforts to control the coronavirus. A configurable COVID-19 laboratory management software can help COVID-19 testing laboratories support new test methods, assays and meet reporting requirements with ease.