CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
BC Solutions explains why third-party blood bank validations might be right for your laboratory in this Q&A.
Congratulations! Your lab is finally installing or upgrading your new blood establishment computer system (BECS). Your team spent months determining the best plan for installation, and you have painstakingly configured the system and data tables to account for all your facility’s unique workflows and processes. But how can you be confident that the system is capable of consistently operating within established limits and tolerances? Validation. There is no question that it must be done. The question is: Who should be tasked with doing the job?
You could assign your own staff to this task, but this is often impractical since they already have full workloads and their productivity is key to patient safety and your lab’s success. The BECS software vendor might do it, but some perceive that scenario as the fox watching the henhouse. Your best option is clear: An independent, third-party validation.
Q: Can I trust the quality of the work done by a third party?
A: Higher quality is often achieved by using external resources who bring not just more validation knowledge, but more specialized processes as well. In addition, having an outside opinion on workflows and SOPs can provide a fresh perspective on ideas for efficiency and quality. An experienced vendor will have the expertise necessary to provide you with the quality your validation deserves. Look for a vendor that employs trained, licensed medical technologists with practical blood bank experience and knowledge of the legal, regulatory, and compliance standards.
Q: Are auditors and assessors satisfied with third-party validations?
A: Absolutely. Third-party validations are superior to in-house validations because vendors can work objectively, without bias or predisposition, while keeping the focus on patient safety. A reputable validation vendor like BC Solutions will also guarantee their work and provide post-validation support in the case of an inquiry or audit. The vendor shares the risk in such an instance, which helps ensure they will provide a comprehensive, well documented validation. Hiring an experienced validation vendor will put you, and any potential auditors, at ease.