FDA proposes new blood-handling rules to prevent spread of HCV.

The federal government is moving ahead to finalize regulations designed to ensure continued safety of the US blood supply. The FDA and HCFA recently published a series of proposed rules for hospitals and blood centers to follow to help prevent the spread of hepatitis C virus (HCV) infections.

"The prevalence of HCV in the US is a significant threat to public health," House Commerce Chairman Tom Bliley, R-VA, said in a recent statement. "And yet, too many people in the US are unaware of this HCV epidemic--and the possibility that they or someone dose to them may already be infected."

The federal government estimates that 4 million Americans have been infected with HCV, and most are probably unaware of it. That estimate is 3 to 4 times that for HIV.

HCV frequently causes a clinically inapparent but chronic infection of the liver. People with HCV usually exhibit no symptoms for about 20 years, but in many cases the disease causes serious liver injury thought to be the leading cause of late-stage cirrhosis and liver failure in the US and plays a significant role in the development of liver cancer.

The federal government estimates that about 7% of those thought to be infected with HCV contracted the disease either through transfusion of infected blood components before the availability of donor screening tests or through past use of nonviral-inactivated plasma derivative products. An estimated 304,000 recipients of blood transfusions or blood products may need to be notified that they are at risk and should be tested.

How the proposed rules work. Under the rules, all facilities involved in the collection, processing, and delivery of blood would be required to identify and notify patients who received blood before 1992, when sensitive screening tests for HCV became available. They would also have to identify and notify patients who may have received blood from donors who were in the "window period." The window period refers to the time frame between contracting HCV and when it is possible to detect it in blood samples. For HCV, this window is 70 days.

In addition, the new rules mandate the quarantine of prior donations from donors who are now positive or who became positive for HCV as a way to prevent window-period transmissions.

Previous FDA guidance contained these requirements and they were implemented by blood centers, says Celso Bianco, MD, executive vice president of America's Blood Centers. ABC is the national network of nonprofit independent community blood centers that collect about half of the US blood supply. The American Red Cross collects the other half.

The new rules would extend to hospitals the mandate requiring patient notification. Fulfilling this requirement would be a condition for participating in Medicaid and Medicare.

Under the rules, hospitals would have to do additional testing on the donor and notify individuals who have received transfusions from the HCV-positive donor. This would take place when such a donor is identified at the time of a repeat donation or after performing a review of testing records to identify donations at increased risk of transmitting HCV.

The FDA is also proposing to extend the record retention period to 10 years to create opportunities for disease prevention many years after recipient exposure to such a donor.

While blood facilities are well prepared for the rules, hospitals will have their work cut out for them. This is especially true if the hospitals perform many transfusions, says Mike Muzillo, an administrator at Valley West Community Hospital in Sandwich, IL.

Hospitals will have to determine who received the blood and identify the recipient's physician. They will also have to contact the patient's physician and ask the physician to inform the recipient that he or she may be at risk for HCV. "The FDA is requiring that if the hospital can't identify the physician, the director of the blood bank or someone in the hospital must carry out notification in a timely manner," says Dr. Bianco.

HCFA estimates that the proposal would cost hospitals about $5 million to develop procedures to notify patients about possible infections and $52 million to review past records for possible patient notification. The agency indicates, however, that it may be possible for hospitals to bill certain state Medicaid programs, and possibly Medicare, for some of these expenses.

While the requirements are relatively labor intensive, the yield from this effort may turn out to be relatively small, says Dr. Bianco. Even so, finding those who were infected before sophisticated screening tests were implemented in 1992 remains a priority for the federal government and the nation's blood banks. The proposed regulations are designed to address that problem.

Interested parties may submit written comments on the proposed FDA rules by February 14, 2000.