As a key component in every blood-banking lab, it is vital that the centrifuge is not only reliable but also can provide fully reproducible, traceable data with every spin. With downstream patient-safety implications, separation of whole blood into red and white blood cells, platelets, and plasma needs to be tightly regulated and, as such, compliance with Good Manufacturing Practices (GMP) is crucial.
The complete process of blood donation is highly complex, and external influences that may affect the integrity of whole blood or the extracted components need to be effectively managed. In 2006, during 16 million blood donations across the U.S.,1 each donor underwent a routine screening via a health-check questionnaire for infections that can be transmitted via the blood. These include hepatitis B, hepatitis C, HIV and human T-cell lymphotrophic virus (a single-stranded RNA retrovirus that can cause leukemia). Following this screening, samples from each donor were tested for the presence of infections; all data results were entered into the donor's individual record; and the donated blood was barcoded for traceability.
Donated blood is subsequently transferred to the lab for processing, where it is separated, enabling a single donation to be used to save more than one life: red cells to replace lost blood during surgery; white cells to treat patients whose normal system is unresponsive to antibiotics; platelets for bone marrow, post-transplant, chemotherapy and leukemia treatments. The centrifugation process is essential in maximizing each donation's usability — and the viability of all spun materials is fundamental to its subsequent usability.
To protect sample integrity, each centrifuge spin needs to be fully reproducible. Variables (e.g., volume fill, power requirements) can affect the acceleration/deceleration times and, potentially, become problematic. To ensure centrifuge runs can be replicated, a unique function has been introduced which assures reproducible blood yields, regardless of external factors. By applying the same g-force to each run, this advanced technology enables automatic run-time adjustments, easily compensating for variations due to full or partial rotor loading.
With a mandatory focus on quality control, blood-banking labs need to be able to effectively trace any given blood sample's path. If, for example, there is a problem with a sample, technicians need to effectively trace the processes that it underwent to identify where the issue occurred. Since blood components can be stored long-term (plasma can be kept in cold storage at -30^0C for up to 12 months), an archive of such data needs to be maintained. Through the use of an external software program, users can adhere to GMP.
Such software programs allow busy blood-banking labs to easily create a digital log, which documents and archives run parameters (e.g., speed, time, date, and temperature). As essential data for any audit trails, such information should always be password protected. With time being of the essence to any lab tech, once connected to a computer system, the software will automatically communicate with the centrifuge scanner. As a result, all scanned blood bags will consistently have associated run data linked efficiently. By automating this process, potential for human error or unreadable handwriting is greatly reduced.
By managing data collection in this way, information is collected in a quick, easy, secure, and accurate manner. Both sample security and integrity are maintained through the ability to check run parameters against set procedures and sound an alarm in case of any deviations from the protocol. The real-time data display of run parameters for all networked centrifuges can be viewed via the direct connection to the system. Furthermore, logged data are compatible with various external reporting systems, or tabular and graphical reports can be generated for remote locations. In using such equipment, tracking and compliance can be standardized across entire workflows.
Since safety is a prominent issue when dealing with blood, compliance is essential; and by adhering to GMP guidelines, labs can ensure each protocol is reproducible.
Bob Magnetti, is senior product manager of floor-model centrifuges at Thermo Fisher which offers Accumulated Centrifugal Effect for reproducible blood yields as well as Centri-Log data-collection software.
- American Red Cross. Blood Facts and Statistics. www.redcrossblood.org: Blood Facts and Statistics. Accessed March 7, 2011.