Human blood and blood components, such as blood plasma, are critically important to every modern health care system. Blood or one or more of its components is used to care for patients who suffered blood loss due to accidents, surgery and the like, or who have certain diseases. Most blood and blood components are obtained from human volunteer donors. For example, the American Red Cross organization operates blood drives in the United States to solicit donors and collect donated blood.
Collecting donated blood is a labor-intensive highly controlled process to assure the safety of the blood product and of the volunteer donor. Collection of blood, and the conversion of that blood into blood component products for transfusion, is controlled and regulated at the same level of rigor as pharmaceutical manufacturing practices. All components, staff and actions involved in the process must be carefully documented. All lot numbers and expiration dates of products used in the process must be tracked and associated with the specific blood donation. These products include a sterile, single-use blood collection container and a variety of other products. Potential donors are questioned about their health and lifestyle, their vital signs are taken and their basic health is checked. Donors cleared to donate have their arms carefully scrubbed with a series of specific skin cleaning products.
A portion of each unit of donated blood will be tested to identify the blood's type and to screen out blood that may be contaminated with diseases or impurities. To facilitate such testing, once a needle has been inserted into a donor's vein, blood samples are drawn and introduced into one or more small sealed evacuated test tubes. After the needle is withdrawn, a gauze pad and a bandage are typically applied to the needle stick location.
Thus, multiple items are required to collect a unit of blood. The items used in a single donation might include a blood collection container, a donor information sheet, multiple arm scrubs, gauze pads, tape, one or more test tubes, a disposable sample site, and a bandage. These items are typically purchased from a variety of different suppliers and stocked in boxes or other containers stored in various locations scattered about a blood donation center. Blood collection technicians must gather these items during the blood donation process.
Items, such as blood collection containers and arm wipes, are manufactured in lots. Each manufactured lot of each item has an expiration date. Blood donation technicians must be careful not to use items whose lots have expired, because blood collected using an expired item may be deemed unsuitable and would be discarded. Furthermore, if a lot of items is later suspected or found to be defective, such as due to contamination or a manufacturing error, all blood collected using any item from the identified lot must be discarded.
Blood is considered to be a manufactured medical product, in that each unit of blood must be traceable back to its donor, as well as to the equipment that was used to collect and process the blood. Thus, blood donation centers must keep records that associate each unit of collected blood with its donor, as well as with the lot numbers of all the items used to collect the blood. This information may then be provided to hospitals or other organizations that use the blood, or it may be used in a quality assurance process for the blood product.
To associate a unit of blood with a donor, a blood donation technician typically uses sheets of adhesive labels having barcodes preprinted on them. A sheet typically contains several identical barcode labels, the format of which is prescribed by regulation. After gathering the necessary items, but prior to collecting blood from a donor, the technician peels the labels off the sheet and applies one such label to the donor's information sheet, another label to each test tube and a label to the blood collection container. However, keeping track of the lot numbers of “consumable” items, such as blood collection containers, disinfecting wipes and bandages, and correlating these lot numbers and their respective expiration dates with units of blood requires manual data entry which, of course, takes time and is susceptible to human error.