Maintaining the integrity and security of valuable biosamples is paramount in the fast-paced world of scientific research. Unfortunately, costly mistakes can occur.
For instance, in a recent article published by the NY Post, a janitor inadvertently turned off an LN2 freezer, leading to the loss of decades’ worth of scientific work and resulting in damages amounting to at least $1 million.
While the incident underscores the serious impact of a single mistake, it also highlights the urgency for comprehensive solutions in biorepository storage. With trusted providers, strict protocols, safeguards to protect samples, and research in place to prevent such catastrophic losses, storage can be less of a concern.
Best Practices for Minimizing Costly Mistakes in Biosample Storage:
As stewards of the biological material which we have been entrusted to safeguard, it is incumbent upon us to ensure the biopreservation of our inventories. Precious and often irreplaceable samples are donated to the cause of science, and we owe it to the individuals who entrusted us with those donations to be the best caretakers to guard against risks.
To ensure that such costly mistakes are avoided in the future, organizations need to implement best practices in sample storage. By incorporating stringent protocols, robust tracking systems, and comprehensive training, biostorage facilities can minimize the risk of human error and machine malfunction to protect the integrity of valuable biosamples and scientific work Some of the key best practices that organizations can implement to prevent such disastrous losses and ensure the security of their samples and research include:
Redundant Sample Storage and Maintaining Offsite Backups:
It is essential to adopt redundant sample storage practices to prevent the loss of valuable biosamples. By splitting samples and storing backups offsite, organizations can significantly reduce the risk of losing irreplaceable research due to equipment failure, accidents, or disasters. Redundancy in sample storage acts as a safety net against human errors, such as accidental freezer shutdowns, which can lead to devastating outcomes.
Moreover, offsite backups are crucial in providing an extra layer of protection. They help mitigate the risk of research loss due to natural disasters, power outages, or facility-related incidents. In an unforeseen disaster at the primary storage location, the offsite backups guarantee that the research and valuable biosamples remain intact and accessible when needed. This approach ensures the continuity of ongoing studies and preserves the integrity of samples for future research. Therefore, planning sample splitting and retention in different locations right from the start is paramount for the longevity and success of any research endeavor.
Continuous Temperature Monitoring:
To maintain the integrity of samples, it is essential to monitor their temperature. Achieving this requires a comprehensive approach, which involves implementing advanced temperature management and monitoring systems that continuously calibrate and measure temperature points. This ensures that storage conditions remain within the optimal parameters for preserving samples.
Incorporating temperature sensors is essential for achieving a higher level of accuracy. Although a standard freezer may provide internal temperature readings, it may not accurately reflect the temperature of the stored samples. By adding sensors, laboratories can obtain precise readings of the actual sample temperatures, thereby preventing discrepancies that could compromise research outcomes.
Continuous monitoring systems with automated alerts are crucial for maintaining ideal storage conditions. They enable real-time tracking and quick responses to any temperature deviations. If mechanical failure occurs, swift action can be taken to rectify the issue, minimizing the risk of sample degradation or loss resulting from temperature fluctuations.
It is also vital to consider the varying temperature specifications for specific products, particularly in contexts of FDA and GXP compliance. Different samples and specimens may have unique temperature requirements. Implementing a temperature management system ensures that these specific temperature specifications are met, guaranteeing compliance with regulatory standards and the quality of research or products.
The situation reported NY Post might have been completely avoided or minimized if proper temperature management practices had been observed. A malfunction triggered the freezer alarm, which led to the unit failing to maintain a constant temperature. Prompt attention to repairing the issue, relocating samples, and monitoring temperature changes could have prevented valuable scientific work from being destroyed and the laboratory suffering significant financial losses.
Robust Sample Tracking and Inventory Management:
To ensure that samples are suitable for research or clinical use, it’s crucial to optimize operations. Laboratories that rely on manual sample labeling might experience a high human error rate. Employees sometimes make mistakes such as inverting numbers, skipping lines, misreading numbers, or having illegible handwriting when labeling or tracking samples manually. These errors can result in difficulties finding the correct sample when needed and could have implications for the viability of research. By employing standard practices like barcoding and indexing, organizations can maintain accurate records of sample location, status, and movements and reduce variations due to handling techniques.
Sample indexing or barcoding assigns unique identifiers to each sample, facilitating quick and accurate identification and retrieval when needed, a particularly crucial step in shared freezer environments where multiple researchers may be storing their samples together. This practice prevents the potential for confusion and disorganization that can arise when unlabeled samples occupy shared freezer space. A comprehensive sample tracking system further enhances organization by enabling real-time monitoring of sample temperature and locations. This ensures that all samples are meticulously accounted for, regardless of the number of researchers sharing the freezer, and are consistently stored at optimal temperature conditions.
Effective inventory management, including regular audits, ensures accurate records and prevents issues like sample expiration or overcrowded freezer storage. These practices support data integrity and the advancement of scientific research.
Documented, Implemented, and Tested Standard Operating Procedures (SOPs) and Disaster Planning:
To maintain consistency and minimize sample and specimen storage errors, well-defined and documented SOPs are essential. These SOPs should include critical processes such as sample handling, storage protocols, data entry, and emergency procedures. By adhering to standard protocols, staff members can consistently handle, store, and track samples across different teams and shifts, reducing variations and preventing mistakes. This approach also helps organizations reduce risks, ensure efficient operations, and adequately train staff members.
In addition to well-defined and documented SOPs for everyday operations, it is equally crucial for organizations to practice emergency response procedures that may not be regularly encountered during routine work and research. This includes high-stress SOPs designed for disaster planning, such as those to be followed in the event of a power outage or other emergencies. Preparing for these one-time events can make a difference in ensuring operations’ continuity and safeguarding valuable samples.
When creating a disaster plan, it is crucial to identify the appropriate contacts and systems to check. This can determine whether the situation is manageable or catastrophic. SOPs with clear instructions should be established to guide staff members in responding effectively to unforeseen challenges. Regular drills and training sessions are necessary to familiarize the team with emergency procedures and actions during critical situations.
Practicing these procedures builds confidence and composure among staff members, enabling them to act swiftly and efficiently during emergencies. Moreover, it fosters a culture of preparedness and proactive disaster planning within the organization, which emphasizes safety and risk mitigation and contributes significantly to the overall success and resilience of the organization.
Lastly, documented SOPs are crucial in quality control and regulatory compliance. They serve as a reference for audits and inspections, demonstrating that the organization has established and follows standardized processes to ensure the integrity and traceability of biosamples. Compliance with regulatory requirements is essential for maintaining the trust of stakeholders and avoiding potential penalties or reputational damage.
Quality Control Team and Quality Assurance Programs:
Creating and applying a highly functional Quality Management System (QMS) that complies with multiple relevant CFR parts strongly indicates a trustworthy biorepository. Implementing vigorous quality control and quality assurance programs is vital for maintaining optimal storage conditions and preventing errors. One effective way to achieve this is by implementing regular temperature monitoring, checks, and alerts, which can detect any deviations from established standards and allow for prompt corrective action.
A dedicated Quality Control team and director can ensure that programs and procedures are consistently followed. The QC team oversees the implementation of the QMS and regularly assesses its effectiveness. Conducting thorough audits, inspections, and internal reviews to identify any potential areas of improvement or non-compliance and proactively address any issues and continuously enhance its operations to meet the industry’s best practices and regulatory requirements.
Proactively collaborating with other departments, such as storage, retrieval, and transport teams, ensures that quality control measures are applied consistently throughout the sample’s entire lifecycle. From the initial storage to retrieval for research or clinical use and the safe return to storage, each step should be monitored and adhered to the established standards.
Adhering to these programs guarantees that samples are stored under optimal conditions, preserving their integrity and minimizing the risk of sample loss or degradation. These measures will ensure the validity of research results and demonstrate commitment to excellence and accountability.
Once all the mandatory requirements have been met, biostorage facilities can take quality control and assurance one step further by acquiring voluntary accreditations and registrations that prove their dedication to high standards. For example, gaining ISO 9001 registration shows a facility’s ability to continuously meet regulatory and consumer standards and its ability to meet ISO 9001 standard guidelines. ISO 20387 accreditation is an international standard for promoting confidence in biobanking institutions and procedures. It is often regarded as a crucial standard for biobanking organizations to meet. Facilities that adhere to the International Society for Biological and Environmental Repositories (ISBER) standards demonstrate their commitment to industry best practices. ISBER’s guidelines serve as a gold standard for biological and environmental repositories, showcasing facilities’ determination to maintain the highest level of quality and ethical conduct. CAP accreditation is applied to institutions that perform complex testing, which requires significant training, expertise, and education.
One of the significant factors for proper sample storage is employing staff that understand the value of the samples within the facility. The news article shows that even a single freezer not maintaining temperature can cause decades of research and sample loss. Unfortunately, staff members can pose significant risks when human error arises.
This incident highlights why organizations should invest in comprehensive training programs for staff members to mitigate these risks. There are existing programs on three primary levels: biobanking workshops, certificates, and master’s programs. Hiring staff with these qualifications and ensuring current staff members get more training will help prevent errors and make for a more prepared team.
In addition to comprehensive training programs for biorepository staff, it is equally important to establish strict protocols and restrictions to minimize potential risks. Proper training and access restrictions contribute to maintaining the integrity of the stored samples and ensuring smooth operations within the facility.
It is essential to provide comprehensive training that covers the technical details of handling and storing samples. Emphasis should be placed on the importance of following SOPs and disaster planning protocols. This training should be extended to all staff members, including those who conduct research, handle materials, or enter the facility for other purposes, such as IT, security, equipment maintenance, and janitorial staff. It is vital to educate everyone about the potential consequences of not adhering to established procedures, such as touching things that should not be touched or causing a freezer to fail. This will help ensure that everyone understands the importance of proper methods and the potential risks associated with deviations from them.
Implementing access controls can enhance security and minimize human errors. Different access levels should be assigned based on staff or vendor roles and responsibilities, restricting access to sensitive areas and critical equipment.
Preserve and Protect your Bioinventory with GenVault:
The incident highlighted in the article emphasizes the critical need for implementing best practices in biorepository storage. This single event caused immense financial and research losses. Though it can be used as a lesson to learn from, the losses must not be ignored, especially when redundancies could have easily prevented this tragedy from occurring. A biorepository has a responsibility to the organization that owns the samples in their freezers and a moral obligation to the donors of those samples.
When operating a biobank facility, the focus should be meeting and exceeding each standard before samples even enter the facility. Designed and built by industry experts to be an industry-leading biorepository, GenVault excels in each of the areas that make it a trustworthy and secure facility:
- Redundant Sample Storage Maintaining Offsite Backups
- Robust Sample Tracking and Inventory Management
- Continuous Temperature Monitoring
- Documented, Implemented, and Tested Standard Operating Procedures (SOPs) and Disaster Planning
- Quality Control Team and Quality Assurance Programs
- Trained staff
We intend to meet each standard, then develop more efficient protocols and processes that help us exceed these standards. From expertly trained staff members to technologically advanced monitoring programs, each potential issue has a solution before the problem can occur.
GenVault Biorepository is ready to assist organizations in avoiding disastrous mistakes like this by storing redundant samples and materials in our state-of-the-art facility. With a focus on biorepository storage solutions, LIMS based inventory management, and advanced security measures, GenVault offers a comprehensive range of services. GenVault’s commitment to security and safety is exemplified by features such as facial recognition, 24-hour monitoring, temperature controls, power backups, and more.
By adopting these best practices and partnering with GenVault, organizations can minimize the risks associated with biorepository storage and ensure the preservation of valuable biosamples. Implementing redundant sample storage, vigorous tracking systems, well-documented SOPs, quality control teams and programs, and comprehensive staff training will safeguard data integrity and enhance operational efficiency and regulatory compliance.
Unfortunately, a single error can cause devasting effects for fragile items like biosamples. Learn from the incident highlighted in the article and proactively protect your valuable inventory. GenVault Biorepository, with its expertise and advanced solutions, is ready to guide organizations and offer state-of-the-art storage solutions.
We commit to ensuring the security and integrity of your biosamples when they are stored with GenVault. Contact us today to learn more about our comprehensive biorepository storage solutions and how we can help your organization avoid costly mistakes while providing the highest quality and safety standards.