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 26^th and 27^th, 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.