Training: The Critical Role in Tissue Banking
When you hear the word “Training”, to some it can be exciting, as it conveys a sense of new opportunities for growth, skill development, and purpose. For others, it could elicit disruption or discomfort as learning something new can be challenging or bring back bad experiences. In our industry, there are no if’s, and’s, or but’s, training is a requirement. Why? Let’s dive in on why training is the backbone of compliance in our industry!
Our industry offers lifesaving solutions to patients ranging from transplantation to advanced regenerative therapies. However, the safety and efficacy of these products not only rely on scientific innovation, but they also depend on strict regulatory compliance and meticulous operational standards. Training is required by the Food and Drug Administration (FDA) to meet regulatory requirements, quality considerations, and operational consistency, which shape our industry.
The FDA’s 21 CFR Part 1271 regulations set the requirements for establishments who manufacture or process and/or distribute Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). These requirements are designed to minimize the risk of infectious disease transmission and cross-contamination which ensures patient and product safety in the transplantation process.
Requirement 1 : 21 CFR 1271.170 states that establishments must ensure that personnel have the necessary education, experience, and training to perform assigned functions effectively. Without proper training, establishments risk product nonconformance, which can lead to recalls, legal penalties, patient harm, and suspension of operations.
Risk Mitigation: The FDA’s guidelines recognize that poorly trained staff are a significant source of risk. Human error stemming from lack of understanding or familiarity with procedures can lead to contamination, mislabeling, improper storage, or transmission of diseases. Training programs are required as a main source for risk reduction, ensuring that personnel are proficient in sterile technique, packaging, labeling, transport, documentation, and handling of complaints and adverse reactions.
Continuous Education: FDA does not view training as a one time event. Ongoing education and periodic competency assessments must be performed. As science evolves and new procedures and processes are introduced, staff must stay current with the latest regulations and updates to protocols. This aspect underscores the dynamic nature of our industry and the need to foster a culture of lifelong learning.
The American Association of Tissue Banks (AATB) goes further providing a comprehensive blueprint for quality and safety in tissue banking with the following but not limited to [2] :
Competency based approach: Initial training is only the beginning and demonstrating ongoing competency is required. Each role has specific knowledge and skills requirements, so training programs must be tailored to ensure staff meet these role-specific competencies. This is done through regular evaluation, retraining, and skills validation which are integral to the quality assurance process.
Accountability and Documentation: Meticulous documentation of all training activities is required. This proves compliance during audits, provides a record of staff qualifications, and enables identification of training gaps. Detailed records are essential for tracing the cause of errors, deviations, or adverse events back to potential lapses in training which allows for targeted improvements.
Aligns with ethical standards: Tissue banking and regenerative medicine wouldn’t be able to impact the quality of patients’ lives without ethical responsibility. Proper training ensures all staff understand the ethics of their work (e.g., confidentiality, informed consent, respect for donors and their families, etc.) and applying them, thereby mitigating risk and builds relationships with those receiving these lifesaving therapies.
Why does training matter? Have you seen the FDA’s Warning Letters?
Letters have been issued to establishments for inadequate training contributing to systemic problems and lapses in quality control that could be traced back to insufficient training. Adverse events in tissue banking stem from human error, and these mistakes can have devastating consequences. A robust training program provides staff with the skills and knowledge to anticipate and avoid errors. Processes involve hundreds of steps and standardizing training ensures that every staff member performs consistently and reliably. This uniformity is vital to meeting regulatory requirements and critical for patient safety and product quality. Training also fosters adaptability and problem-solving skills that ensures staff respond quickly and effectively.
What are some challenges? These include, but are not limited to:
Underestimating training needs – some organizations provide only basic orientation or infrequent refresher courses. By doing this, they fail to recognize the complexity and risk in their operations.
Poor documentation – inadequate recordkeeping undermines the ability to prove compliance, track competency, impacts root cause analysis, and audits. We’ve all heard of the saying, “If it’s not documented, it didn’t happen!”. Lack of documentation (i.e., traceability) opens doors to higher risks.
Failure to update training – regulations change and best practices constantly evolve, so outdated training materials increase the risk for noncompliance and compromises safety.
Lack of engagement – some trainings may be too passive and not engage staff to learn. Using different active methods such as interactive, hands-on, and scenario driven approaches are more effective in imparting real-world skills.
Here are some best practices:
Assess the Needs: Evaluate the specific functions and risks to each role to design targeted training programs.
Regular Competency Assessments: Perform periodic evaluations and retraining to ensure ongoing proficiency.
Document! Document! Document! Did I mention document? Maintain detailed records of all training activities, include dates, materials used, and competency/proficiency outcomes.
Continuous Improvement: Ask for feedback from staff, review incident reports and update training materials based on new regulations and lessons learned.
Make the Learning Experience Fun: Use interactive simulations, case studies, peer-to-peer mentoring to foster active engagement and retention. Consider external courses and webinars for ongoing education and interaction.
Ethics and Sensitivity Training: Embed the ethical dimensions of tissue banking into every training module, reinforcing the importance of respect, confidentiality, and empathy.
Training is the heart and backbone of tissue banking compliance and quality. It’s not a “try” effort, it’s a “required” effort that is the foundational safeguard that protects donors and patients, and, ultimately, public health. Well trained staff are the most reliable defense against errors. By investing in rigorous, continuous, and competency driven training programs, establishments support a culture of continuous improvement and fulfill their mission with excellence, integrity, and trust.
Do you feel overwhelmed, underwhelmed, or even have questions on where to start with your Training Program in the tissue banking industry? Contact us here with your questions!
Thanks for joining us and check back later for our next blog on industry trends!
References
[1] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-L/part-1271
[2] The American Association of Tissue Banks, Standards for Tissue Banking, 15 th Edition