Top Toolbar

 

Blood Safety and UDC

Safe blood and blood products are essential for people with bleeding disorders. Throughout their lives, people with hemophilia and other bleeding disorders depend on blood clotting factor products to supply a missing protein needed for normal clotting.

History

At one time, clotting factors were all derived from human blood plasma (called plasma-derived products). The missing clotting proteins were isolated from donated blood, freeze dried, and made into a powder. The powder could then be mixed with sterile water and injected into a patient’s vein during a bleeding episode.

Plasma-derived products are now considered very safe, but that wasn’t always the case. During the 1980s, the nation’s blood supply became contaminated with HIV. Since that time, historic efforts have been taken to make the blood supply safe. Advances in donor screening methods, laboratory tests to detect blood-borne viruses, quality control measures, and viral inactivation and manufacturing processes have resulted in safer, more effective products. These improvements have virtually eliminated the risk of HIV and hepatitis B and C transmission.

Today, recombinant clotting factor products are available. They differ from plasma-derived products in two ways: they are either completely free of human plasma or use tiny amounts of pasteurized human serum albumin for cell culture or as a stabilizer. Pasteurized human serum albumin has a 50-year safety record of no viral transmission.

On-Going Monitoring

Today, clotting factors are considered safe from contamination with known viruses. In addition, continued monitoring of blood products provides an additional measure to ensure their safety. With this in mind, the Centers for Disease Control and Prevention (CDC), in cooperation with federally funded Hemophilia Treatment Centers (HTCs), established the Universal Data Collection Project (UDC).

Persons with bleeding disorders are eligible to enroll in UDC at their participating HTC. As part of the program, clinical data and a blood sample are collected from participants each year during their annual clinic visit. A portion of the blood sample is tested for viral hepatitis (hepatitis A virus, hepatitis B virus, hepatitis C virus) and HIV, and the remainder is stored for possible use in future blood safety investigations.

For more information about Blood Product Safety, go to the CDC or NHF.

Why Should I Take Part in the UDC System?

The more participants enrolled in the UDC system, the more information can be gathered and better are the chances of advancing the care of people with bleeding disorders.

Here are some other reasons to consider taking part in UDC:

  • It’s confidential
  • There’s no cost for the laboratory tests
  • It protects you and other members of the community from potential blood safety threats
  • It improves care for current and future generations through research discoveries
  • It helps identify and prioritize issues that require further study

What Information Is Collected for the UDC System and How Often?

Typically data are collected at routine annual care visits to a HTC. The health information collected for the UDC system and how often you are asked to update this information depends on the type of bleeding disorder and age. At each annual visit, the HTC staff may:

  • Review your medical record and ask you some questions
  • Collect a sample of your blood for virus testing and to store or bank it for possible use in future blood safety studies
  • Measure how well your joints (for example, your hips, knees, shoulders, elbows, and ankles) move to see how your joint health may change over time
  • Test your blood to check your iron level
  • Ask you to fill out a survey about your quality of life

Is Information Kept Private?

Yes! You will be assigned a unique identification number, which will be placed on all Universal Data Collection Project forms and blood samples so that a patient’s name is never revealed to anyone outside the HTC. Not even a court of law can make your HTC give out this information.

Confidentiality and the Patient Bill of Rights

Hospitals have a patient bill of rights that guarantees the level of participation a patient has in his or her care. This document includes but is not limited to the right to unbiased treatment, the right to diagnosis and prognosis information, the right to emergency aid, and the right to voice grievances; the most important being the right to privacy and the right to confidentiality of all patient records. You should check with your health care provider for their Patient Confidentiality and Bill of Rights, and go over any questions you may have with them.