New Food and Drug Administration statistics show that unlicensed blood centers
in fiscal year 2004 were making the adjustment to a new requirement that they
report any errors to the FDA.
The reporting requirement applies to any error associated with manufacturing,
holding, or distributing a licensed biological product, including testing, processing,
packing, labeling, or storing the blood or blood component.
Formerly called “errors and accidents,” these events have been
termed “biological product deviations” since 2000, when the FDA
published a rule expanding the requirement that blood component manufacturers
and blood centers report the errors promptly.
That rule took effect Oct. 1, 2003, making the error reporting requirement—which
always applied to licensed facilities—applicable to unlicensed facilities
as well. It covers any event in which the safety, purity, or potency of the
product may be affected. Such events could be caused by deviations from current
good manufacturing practices, regulations, standards, or specifications, or
by unexpected or unforeseeable events.
If a reportable event occurs, the manufacturer, unlicensed blood center, or
transfusion service must report to the FDA’s Center for Biologics Evaluation
and Research, Office of Compliance and Biologics Quality, as soon as possible,
but within no more than 45 days.
But because the reporting expanded so recently, it’s wise not to
read too much into the FDA’s fiscal 2004 annual summary report,
cautions James AuBuchon, MD, chair of the CAP’s Transfusion Medicine
Resource Committee and medical director of the blood bank and transfusion
service at Dartmouth Hitchcock Medical Center, Lebanon, NH.
“This is still a new system, and I think hospitals and blood collectors
are still learning how to apply it and exactly what has to be reported,”
he says. For example, the annual summary for fiscal 2004 reveals that
some of the reports received did not meet the threshold for reporting
and were not captured in the database. The 37,830 reports from blood and
plasma establishments that were actually required represented a seven
percent drop from fiscal 2003. That may be just because the newness of
the rule is wearing off, Dr. AuBuchon says.
The fourfold increase seen in problems with “un acceptable, undocumented,
or incomplete product QC” may be a result of blood centers adjusting to
new testing. While 105 reports were submitted in fiscal 2003, 527 reports were
submitted in fiscal 2004—more than half related to the implementation
of bacterial detection testing used as a quality control test.
“Bacterial testing systems are labor-intensive, and like any new test—particularly
with those that are not of the type that blood collectors are used to using—they
offer a new opportunity for making errors,” Dr. AuBuchon explains.
In addition, many events listed as “errors” are essentially problems
with the system of testing. “For example, a unit that’s collected
Monday might be tested Tuesday and sent to the hospital on Wednesday, yet the
result indicating there was a question about a unit for transfusion might not
become available until Thursday. So the blood center would have done nothing
wrong in the whole process, yet would have to file an error report with the
Deviations and unexpected events related to the donor screening process
continue to lead the causes of potential recall situations, the FDA report
also said. Dr. AuBuchon says the accuracy of donor rec ords is a perennial
issue. “There are so many elements of the record that must be completed
accurately that the donor’s medical history represents a fertile
source for errors.”
If a donor forgot that he had traveled to an area where malaria is endemic,
and corrected his travel history later, for example, it’s usually
an oversight, he says. Such incidents could add up to the tens of thousands
but would have to be reported, even though only a tiny number of units
actually transmit malaria. “The number of events reported dwarfs
the number of occurrences where that information truly would have been
Computerized systems that can capture health history and alert nurses at donation
sites to facets that may require further investigation are now being marketed,
Dr. AuBuchon says. “Not many blood centers have yet adopted such systems,
but they would decrease errors significantly.”
The FDA is still reviewing two draft guidance documents to help blood centers
determine what events are reportable, and plans to publish the guides soon.
Anne Paxton is a writer in Seattle. For further information: FDA's guidance
documents including "Biological Product Deviation Reporting for Blood and
Plasma Establishments," www.fda.gov/cber/guidelines.htm; Biological Product
Deviation Reporting for Fiscal Year 2004,www.fda.gov/cber/biodev/bpdrfy04.htm