Inspections are a great learning opportunity. Our recent American Association of Blood and Biotherapies (AABB) introduced us to the risk analysis requirement in its 2024 checklist. Though the requirement is specifically stated in 3.7 Information Systems #13, the requirement can be applied to instruments as well as software. The update is significant as it emphasizes the need to proactively identify, assess, and mitigate risks associated with introducing or modifying software and instruments within the laboratory setting.
AABB-accredited laboratories will need to review their validation procedures to ensure they include a risk analysis with mitigation for identified risks. There are a few steps to conducting a risk analysis.
First, clearly define the changes being made. This could include new software installations, updates to existing software, introduction of new instruments, or modifications to current equipment. Understanding the full scope of changes is essential for a comprehensive risk analysis.
Secondly, if possible, form a multidisciplinary team that includes IT specialists, laboratory managers, quality assurance personnel, and end-users. In reality, for many small to medium laboratories, frequently one person fills more than one role. It’s conceivable for the laboratory manager to be the quality person and an end user since they often may have to fill in during staff shortages.
Next, identify the risks. Structured techniques like Failure Modes and Effects Analysis (FMEA) can be used to identify potential risks. Consider software-based risks such as data loss or corruption, system incompatibility, user interface issues, and cybersecurity vulnerabilities. Calibration errors, operational failures, compatibility with existing systems, and maintenance requirements are some instrument-based risks that should be considered. And, of course, human-based risks involving user errors, poor or insufficient training, and workflow disruptions.
The fourth step would be to assess each identified risk, assessing its potential impact on laboratory operations and patient safety and evaluating the likelihood of occurrence and the severity of consequences if the risk materializes. Use a risk matrix to categorize risks as low, medium, or high.
For each high or medium risk identified, develop mitigation strategies to reduce the likelihood of occurrence or minimize the impact. Some examples are increasing training programs, additional testing, or developing contingency plans for failures.
Ensure the entire risk analysis process is documented, including the identified risks, evaluation results, and mitigation strategies. Documentation is crucial for compliance with the AABB checklist and is a reference for future audits or inspections.
The risk analysis requirement in the AABB’s 2024 checklist underscores the importance of proactive risk management in clinical laboratories. Through the implementation of the outlined steps, laboratories can not only meet this requirement but also enhance their operational resilience and commitment to patient safety. Conducting a thorough risk analysis for software and instrument changes is an investment in the quality and reliability of laboratory services, ultimately contributing to better patient outcomes.
-Darryl Elzie is the Regulatory Affairs Manager Inova Blood Donor Services. He has been an ASCP Medical Laboratory Scientist for over 25 years, performing CAP inspections for two decades. He has held the roles of laboratory generalist, chemistry senior technologist, and quality consultant. He has a Master’s in Healthcare Administration from Ashford University, a Doctorate of Psychology from The University of the Rockies, and is a Certified Quality Auditor (ASQ). Inova Blood Donor Services is the largest hospital-based blood center in the nation. Dr. Elzie is also a Counselor and Life Coach at issueslifecoaching.com.
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