Hospitals and blood banks are grappling with changes in how the Food and Drug Administration regulates the production of blood products.
Those changes are one force behind the steep and rising cost of blood, which now averages from $60 to $75 per unit. Prices for blood products are advancing more rapidly than most other hospital supplies-at a rate of 6% to 9% this year, according to a recent report by New York-based Joint Purchasing Corp. (See related story, p. 40).
Each test to assure blood is disease-free adds $1 to its unit cost, said Bill Coenen, president of the 62-member Council of Community Blood Centers.
Meanwhile, compliance with FDA draft guidelines for quality assurance adds $5 to $6 to a unit's cost, he said.
Late last month, the nation's largest blood supplier moved to meet those guidelines. The American Red Cross set up an independent quality-assurance program that is able to stop operations at blood centers if necessary.
Its action is the result of a 1993 consent decree with the FDA. A voluntary agreement in 1988 failed to correct repeated violations of FDA standards, including those covering quality assurance, an FDA spokeswoman said.
The Red Cross' troubles probably fed stricter enforcement of FDA regulations at all the nation's 2,500 blood centers. Certainly, growing awareness of bloodborne diseases also is behind much of the FDA's efforts, observers said.
In the past few years, the number of warnings handed to blood banks reportedly has soared. Neither blood-bank associations nor the FDA could provide data to document the increase. FDA spokeswoman Monica Revelle said that while FDA enforcement had sharpened, it still revoked the same number of blood-bank licenses when problems cited in warnings weren't addressed.
It is clear, however, from speeches by FDA Commissioner David Kessler, M.D., that the agency no longer regards blood banks as providers. Instead, it views them as manufacturers.
The distinction means the FDA more often holds blood banks to rigid manufacturing practices as well as to regulations specific to blood, Mr. Coenen said. Under manufacturing standards, blood banks must know not only who donated a unit of blood but also in which centrifuge it was processed, for example. Because centers haven't always gathered that data, the number of warnings issued has risen, he said. The manufacturing practices also require quality-assurance programs. Ms. Revelle didn't know if manufacturing standards have been applied more frequently.