Blood Safety Recommendations - January 2000
DATE: February 7, 2000
TO: Interested Parties
FROM: Stephen D. Nightingale, M. D., Executive Secretary
Advisory Committee on Blood Safety and Availability
SUBJECT: Resolutions Adopted at the January 26th and 27th, 2000 Meeting
1. The Committee directs its staff to create on the Committee's web site
a list of key recommendations that the Committee has made, in a format that
would permit the public to see what progress has been made in implementing
each of these recommendations
2. The experience of aviation and other industries supports the use in all
blood establishments (i. e., both blood and plasma collection centers and
facilities that provide transfusion services) of a confidential, non-punitive
system for the management of errors and accidents not subject to regulatory
requirements.
3. All blood establishments should have a quality assurance program.
4. Quality assurance programs in all blood establishments should capture,
analyze, and respond to data on all deviations from established procedures,
as well as errors and accidents, independent of whether affected blood units
were distributed or caused adverse medical events.
5. FDA should extend its current error and accident reporting requirements
to apply to all blood establishments, including hospital transfusion services,
rather than only to licensed blood establishments.
6. In order to facilitate improved transfusion safety, for errors and accidents
not subject to regulatory requirements, there should be established outside
the regulatory framework an effective, confidential, non-punitive system for
the accumulation, analysis, and dissemination of data from all blood establishments quality assurance programs.
7. Industry and government should be encouraged
to facilitate the evaluation and implementation of devices that promise to
prevent misidentification of blood products and/or patients.
FOLLOW-UP
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