Substantial improvements in performance indicators achieved in a peripheral blood mononuclear cell cryopreservation...

Multicenter clinical trials require reliable storage of peripheral blood mononuclear cells (PBMC). Prior research has shown that cryopreservation standards vary across labs. No prior work had resolved how to consistently achieve high viability and yield. This gap motivated the development of a quality assurance program. The program aimed to evaluate and improve PBMC preparation across multiple sites. It focused on using single donor samples to standardize testing. The program included both HIV-positive and HIV-negative samples. The goal was to identify effective interventions for quality improvement.

The study aimed to assess and enhance PBMC cryopreservation quality across an Australia-wide laboratory network. It sought to establish a reproducible standard for PBMC viability and yield. The program used single donor samples to ensure consistency. Laboratories were evaluated on their ability to meet specific quality thresholds. The study also aimed to identify interventions that could improve performance. It targeted both initial and ongoing quality assurance. The program included accreditation for trial participation. It focused on achieving viability above 80% and yield above 50%.

The quality assurance program used single donor blood samples from both HIV-positive and HIV-negative individuals. Samples were shipped to participating laboratories for PBMC preparation and cryopreservation. Laboratories were assessed on viability and yield after thawing. The program included three rounds of performance evaluation. Interventions included telephone interviews with lab staff. Annual wet workshops were conducted to share best practices. A senior scientist was available for post-round discussions. Laboratories were monitored for improvement over multiple rounds.

Initial program rounds showed many labs failed to meet quality targets. Viability and yield thresholds were not consistently achieved. After interventions, most labs improved significantly. Viability improved with P = 0.002 and yield with P = 0.001. Three labs maintained high standards from the start. Two labs showed no improvement despite interventions. The program demonstrated that targeted support can enhance performance. It also showed that consistent monitoring is effective.

The study showed that quality assurance interventions can improve PBMC preparation. Laboratories that initially failed saw substantial gains in viability and yield. The program proved that support structures enhance performance. It also showed that some labs can maintain high standards. The findings suggest that monitoring and training are effective. They support the use of single donor samples for quality testing. The program contributes to lab accreditation for clinical trials. It highlights the importance of consistent quality assurance.