Safety of blood and blood components is the major concern of every blood center that requires quality systems and state-of-the-art infrastructure to maintain good laboratory practices in spite of heavy workload. This implies recruitment of voluntary donors, proper collection and component separation process, and screening of collected blood for transfusion transmissible infections.

New advances, particularly in the area of automation, have enhanced both safety and blood availability. Industry efforts currently are focused on increasing blood supply in global markets and improving education efforts for a safe and sufficient blood supply worldwide.

The global blood market, which includes equipment and devices used for collecting, processing and transfusion of blood and the sale of blood therapeutics, was estimated at USD 30.1 billion in 2014, according to BCC Research. By 2019, these products are forecast to reach USD 38.2 billion in sales, reflecting a CAGR of 4.9 percent during 2014-19. The largest segment of the market, blood therapeutics, will reach revenue of USD 31.1 billion. Blood typing and screening products, the second-largest and fastest growing segment, is forecast to reach USD 3.4 billion in revenue at a 5.4 percent CAGR.

Automation, successfully implemented in blood banking laboratories, has sparked growth in the market. Indeed, a large number of manufacturers have introduced next-generation products to replace first-, second- and even third-generation systems. The latest systems, which are completely automated, can process many more test samples per hour. Automation has also accelerated the donation process.

Traditionally, donors donate a single unit of red blood cells using manual procedures. But new technology makes possible the collection of two units of red cells from a single donation using a process called double red cell apheresis. Blood typing and disease screening has also benefited from automated instruments.

In addition to automation, other key market influences include collection and processing costs, technological advances, an ageing population, growing demand for plasma-derived therapeutics, and the changes in the incidence of diseases and surgical procedures and catastrophes requiring blood transfusions.

Recent developments in safety testing and quality assurance of blood and plasma also have affected the market. These critical developments include incorporation of genetic engineering techniques to make recombinant clotting factors and human serum albumin; new methods of processing blood; and the discovery of other specialized blood cells such as stem cells and dendritic cells.

Automation in Blood Collection and Processing

Manual blood collection and processing is a tedious process involving many operations including centrifugation and component separation, among others. Large blood centers have heavy workload and therefore there is a risk of errors when operation is manual which compromises blood safety. Mistaken identification of recipients and of the units of blood components to transfuse is still the most frequently reported error to the international hemovigilance systems. Automation eliminates manual errors, reduces manpower requirements, and has uniform performance. The safety of transfusion therapies for patients depends in part on the distribution of blood products. 

Automated equipment and devices reduce manual operations. Companies are developing automated blood collection devices that minimize contamination risk associated with blood collection and processing. Reduced human intervention lowers the chances of contamination. Automated alternatives, which include autologous disposables and devices, have been gaining significant popularity over the last couple of years. Automation in blood collection and devices has many advantages including barcode system that prevents sample identification errors and prevention of human errors in interpretation of results and transcription errors while documenting the results.

Other major technological advancements in the field include development of blood bags with blood collection monitors, and integrated filers as well as tube sealers. Blood collection monitors are also being launched with other advanced features such as fully automated pre-installed software systems and multiple donor management for better control of blood collection quality, as well as donor health during the donation process.

Companies have also developed tube sealers with rapid charging facilities to ensure high quality sealing on a continuous basis with relatively less charging times. RFID technology enabled blood bank refrigerators represent the latest innovation in blood refrigeration.

Semi-automatic equipment is available for separation of plasma, red blood cells (RBC), platelets, with the advantage of leuko-reduced products. These component processors use top and bottom or top and top blood bag systems.

IT supports fast and easy access to process data generated in the blood supply chain, including manufacturing, labeling and inventory, facilitating and improving compliance with good manufacturing practice. The International Society of Blood Transfusion has been working toward automation and data processing pertaining to all barcode messages on labels. It has established guidelines for validation of automation systems in blood banking and maintaining their validation state. These guidelines have been recognized by blood establishments and suppliers of automated systems as a useful document in promoting a standardized approach to the complexities of validation projects for critical computer systems and equipment in blood establishments.

The blood bank activities which are benefited include

  • Collection and whole blood processing using automated systems like cell separator, electronic blood collection monitor, and component extractor
  • Laboratory equipment like fully automated ELISA system, immunohematology system, and automated culture system
  • Information management systems

Besides barcode system, another technical innovation is radio frequency identification device (RFID). It is a promising technology that has the potential to make identification, storage, handling, and distribution of blood and its products a more efficient and safer process. The RFID tag communicates with the RFID reader via radio waves, which sends identity to the database. Unlike barcode technology, the RFID system can read quickly, accurately, and simultaneously. It offers a more secure and traceable solution.

Automated platforms differ in their technical specifications, throughput, turnaround time, and sample loading operation and employs devices like micro-plates or gel columns. The tests performed on these systems include ABO-RH grouping, phenotype, irregular antibody screening and compatibility testing. Fully automatic systems manage all the steps from sample positioning on the carrier down to the final result. Semi-automatic systems require intervention of an operator for the phases of centrifugation, stirring and incubation, with the reading being automated for all. All systems include the possibility of a connection to the central data processing system through an interphase.

Electronic cross-matching. Computer cross-matching is an efficient and safe method for assigning blood components, based on IT applied to typing and screening. The computer or electronic cross-match replaces the immediate spin cross-match for detecting ABO incompatibility. It is essentially a computer-assisted analysis of the data entered from testing done on the donor unit and blood samples drawn from the intended recipient. Based on the barcode of the accepted sample, the software prevents the allocation of ABO incompatible blood and checks the congruence of the historical data by controlling the results of tests conducted on different samples at different times.

The software allocates a unit, choosing the one that is most compatible with regards to ABO/Rh blood groups and closest to the end of its shelf-life. Furthermore, at the time of releasing the unit, the program checks that the allocation label has been attached to the correct bag, by reading the barcodes of the donation code and blood component-bag code which are on the unit, and the unique identification. When offered with fully automated pre-transfusion testing, computer cross-matching offers significant potential for rapid service.

Electronic cross-match reduces the risk of human error through the use of software controlled decision making but high degree of validation is required to ensure accuracy. It can be used only if there is absence of unexpected antibodies in the intended recipient.

Future Scope

In the modern blood collection equipment and devices, quality is the primary goal to achieve blood safety. Therefore, continuous scientific progress coupled with automation and computerization is the future requirement for maintaining highest level of quality in blood bank. Future testing algorithms in blood centers will be a combination of new multiplexing techniques with existing blood testing assays. The DNA microarray technology in transfusion medicine helps in the identification of new genes and to learn more about infectious diseases. It offers a promising tool for high-throughput genotyping for red cells and platelet antigens. The automated technique for extended blood group genotyping having multiplex analysis potential is likely to dominate future immunohematology laboratories.

Industry Speak


Five Golden Rules to Avoid Pre-analytical Errors in Blood Gas Testing

Marie-Claude Lachance

Marketing Manager,

Medica Corporation

Pre-analytical errors are quite frequent in the area of point-of-care testing (POCT), wherein most of the blood gas installations are happening today.

Blood gases are important elements of critical care testing. Results have an immediate impact on the course of the treatment. The quality of the results does not only rely on the performance of the blood gas analyzers used, but also on how samples are being drawn.

There are several sources of blood gas pre-analytical errors, including post-draw metabolism, steady state, heparin type and concentration, air contamination, storage and transportation, collection device, and specimen mixing. Risks associated with these errors can be significantly reduced by following these simple five golden rules:

Using balanced heparin blood gas syringes and capillaries to prevent blood from clotting. Clotting will have direct impact on performance of the sensors and may impact the reliability of the results in between quality controls.

Mixing samples adequately. Mixing gently within 30 seconds of taking samples will ensure proper blending of the heparin within the sample to minimize clot formation. Strongly agitating the sample will hemolyze the sample and influence potassium results.

Testing samples in a timely manner. Air-free samples should be analyzed within 10 minutes for capillaries and 30 minutes for syringes at room temperature. Both capillaries and syringes should remain capped right until the time to run the sample.

Storing samples in an ice water bath to inhibit cells from metabolizing for upto 60 minutes. This will help avoid changes in pH, pCO2 and pO2.

Avoiding interference by preparing the site adequately prior to sampling. Benzalkonium is a common interfering solution. Arterial and venous catheters must be adequately flushed dependently upon dead space volume of the catheter.

Observing these suggestions will not only help improve the quality of the results and minimize risks associated with wrong medical intervention, but also assist with validation and correlation studies, and enhance the overall experience when working with a blood gas analyzer.


 

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