Maurizio Merli and Joe Arteaga examine best practice considerations for successful blood banking and look at innovations in some of the instrumentation involved in the processing, tracing, storage, and monitoring of blood.
Every day, donated blood is needed for a variety of reasons, from fighting cancer and treating chronic disease, to replacing blood lost in traumatic accidents. Because blood products are perishable and supply depends on voluntary donation, it is difficult to stockpile blood in preparation for disasters or periods of high demand. Fortunately, procedures for blood processing and banking have improved substantially over the years, through centrifugation and cold storage innovations that optimise preservation of this precious resource, maximising availability of quality blood product.
Blood banks are organised into systems of clinics, mobile units and hospital divisions located in specific geographic areas. The term ‘blood bank’ typically refers to the facilities where blood products are tested to ensure safety for medical use, and later stored. However, it can also refer to a collection centre, as some testing and storage facilities also perform blood collection. Recent technological solutions for blood processing, testing and cold storage allow blood bank managers to choose instruments and products appropriate for the volume of blood that is processed at a particular centre, thus optimising efficiency of operations and inventory management.
The blood banking process
Blood banking encompasses the collection of blood, separation into different cellular and plasma components, and storage of the resulting blood products under conditions that preserve function for as long as feasible. It also includes typing for transfusion (ABO group and Rh antigen) and testing for red blood cell antibodies and a number of infectious diseases, to reduce the risk of transfusion-related adverse events. This highly complex process is performed under specific standards, to ensure transfusion efficacy of the resulting products. Most blood is collected as venous blood with an added preservative, or ‘whole blood’ (WB), and is then separated by centrifugation into red blood cells, cryoprecipitated antihaemophilic factor (AHF), platelets and plasma, which can later be transfused to multiple patients with different needs. Whole blood and packed red blood cells require storage at 1°C-6°C, for a maximum period of 42 days. Blood plasma is processed into a variety of products that must be stored frozen at -18°C or lower.
Key blood banking considerations
Traceability: Given the downstream implications for medical safety, processing of whole blood into its components is tightly regulated and requires compliance with current Good Manufacturing Practices (cGMP). Blood banks must be able to trace the processing path of any given sample, and maintain associated data throughout the shelf life of the final products. The use of software solutions can streamline adherence to cGMP requirements, document different processing parameters, and generate automated reports for audit trails with reduced potential for human error.
Choice of centrifuges: Centrifugation is at the core of blood bank operations, with most laboratories needing to invest in more than one type of centrifuge. There are different considerations important to determine the type of centrifuges that best meet the needs of a particular laboratory.
* Large capacity centrifuges maximise have built-in features that simplify use, thus accommodating high demand and multiple users for increased productivity. They may also include rotor management features that allow regulation of run parameters, enhancing consistent performance.
* Models that accept a broad range of rotors and accessories for diverse applications can represent a cost-effective solution for many laboratories. Specialized rotors are available to fit a wide range of containers, high-throughput processing, or blood bag variations.
* Benchtop designs help maximise capability with a reduced foot print.
* In addition to reliability, it is vital that centrifuges provide fully reproducible, traceable data with every run.
Cold storage: The viability of blood products requires storage within specific temperature range at all times throughout their shelf life, and therefore accurate, stable and reliable cold storage equipment is paramount. Blood bank refrigerators and plasma freezers must adhere to cGMP, and exhibit specialised technical features for temperature stability, control and monitoring:
* Heavy insulation all around to support long hold-over temperature with normal use (door opening or product loads at room temperature). If the power fails, temperatures inside the storage unit won’t stay cold for long. It is important to have a back-up plan and a wireless monitoring solution in the event of a mechanical or power failure.
* Glass doors (refrigerators) and roll-out drawers in some designs, to enable users viewing content without affecting interior temperature.
* Auto-defrost systems with time- and temperature-controlled cycles that defrost only when necessary and within safe temperature range.
* Powerful compressors for forced air circulation to ensure uniform temperatures at all points in the refrigerator or freezer.
* Dual cabinet temperature probes to monitor temperatures in multiple points in the cabinet.
* External temperature display and audiovisual alarm systems for temperature monitoring, with differential signals alerting to the source of the problem that compromises temperature stability (temperature outside range, power failure, or door-ajar conditions). Microprocessor control allows flexible set points and accurate temperature control. Temperature settings should be factory preset to standard or custom specifications, and maintain an accuracy of ±0.1°C. Some systems feature additional alarm test functions to simplify inspection and ensure proper operation.
Continuous monitoring: Remote monitoring systems enable surveying critical blood bank equipment like refrigerators and freezers, in real-time, throughout the entire facility. This is particular important after laboratory hours or at other times when blood banks are unstaffed. These systems are designed to monitor a diversity of parameters 24/7 and send out instant, customisable notification of power or mechanical failures. Wireless sensors can simultaneously monitor the temperatures of different cabinets, internal compartments, or transport coolers. In addition, the monitoring systems offer multiple reporting options to meet a range of needs.
Sample security: Blood bank storage cabinets have stringent security measures to prevent tampering, and should meet all the requirements of the European Directorate for the Quality of Medicines & HealthCare (EDQM) and The European Committee on Blood Transfusion (CD-P-TS). They feature devices like locking doors to control access and protect the content, limit the chances of contamination, and minimise waste. Locks may be operated with keys or number pads, and the most sophisticated systems use integrated electronic systems that control opening by PIN access, and can generate an audit trail of all refrigerator entries, specifying method of entry, user, date, time and duration.
Conclusion
Daily practices for blood processing, testing and banking require highly dependable, standardised laboratory operations, as well as internal policies to avert sample contamination or damage, and to ensure transfusion safety and efficacy. Centrifugation and cold storage equipment that provide the necessary uniformity, reliability, performance and security for blood banking constitute a key investment that can bring exceptional benefits. Manufacturers have designed centrifuges and cold storage instruments with advanced features that are simple to use and support higher productivity to meet an increasing demand.
Maurizio Merli is Product Director, Centrifuges, Thermo Fisher Scientific, and Joe Arteaga, Product Manager, High Performance Laboratory Refrigerators, Thermo Fisher Scientific.
