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Blood Safety Recommendations - April 2000

DATE: May 1, 2000

TO: Interested Parties

FROM: Stephen D. Nightingale, M. D.
Executive Secretary, Advisory Committee on Blood Safety and Availability

SUBJECT: Recommendations of the Advisory Committee on April 26, 2000

1. The Advisory Committee on Blood Safety and Availability recommends the establishment and implementation of a national reporting and analysis system for transfusion medicine as a basis for action to reduce and prevent morbidity and mortality due to human and system error.

The Advisory Committee is favorably impressed with the accomplishments of the error reporting and correction systems that have been developed to improve the safety of air travel by the aviation industry, and by the interaction of federal regulatory agencies with this system.

The Advisory Committee acknowledges the efforts of the FDA working with the blood and plasma collection industries in reducing errors and accidents, and is favorably impressed with the results to date of the MERS-TM error management system. While a great deal has been accomplished in blood collection and processing, the Committee now believes that the opportunity exists to apply these principles to transfusion practice.

Error management systems should acknowledge the right of patients to know of any risk or harm suffered as a consequence of any error or accident related to blood products received. At the same time, there should be statutory protection from disclosure for voluntarily reported information and of quality assurance activities that are not associated with potential or actual harm, provided that the information is also not associated with reckless or intentionally harmful acts. These error management systems should complement, and not replace, current regulatory activities, notably but not exclusively in the area of product safety. All analyses of collected data should be made available in a timely manner to regulatory agencies, national transfusion medicine surveillance programs, and other participants in a reporting system.

Congress should appropriate sufficient funds to develop these systems and for an infrastructure sufficient to support and maintain them in the FY 2001 budget. Congress should stipulate that these funds should not be reallocated for other purposes and that no other funding should be reduced because of the availability of these funds. Funds necessary to maintain these systems should be appropriated annually.

2. There is a small but non-zero risk associated with the use of blood products or plasma derivatives that cannot be eliminated with current technologies. The Advisory Committee therefore supports the prior recommendation of the Institute of Medicine, and of others, that a national system to compensate prospective national system for recipients for injuries or death caused by blood products or plasma derivatives and not associated with a reckless or intentionally harmful act should be enacted and funded by Congress.

3. Whereas the Advisory Committee on Blood Safety and Availability is dedicated to insuring patient access to safe blood products and services, and whereas the Committee recognizes that fair, accurate, and timely reimbursement, including Medicare, for blood-related therapies is critical to insuring patient access to the safest possible blood, the Advisory Committee, consistent with its prior recommendations, recommends that the Secretary and Congress support legislation to insure fair and accurate reimbursement for inpatient blood-related products and services. Such legislation should provide sufficient funding to account for increased blood-related costs, including those associated with new blood safety measures, and require that these costs be reflected in annual updates of inpatient diagnosis related groups.

4. The Advisory Committee recommends that HCFA promptly distribute guidelines for coding and billing of blood and plasma products to all entities covered by the outpatient prospective payment rule. Furthermore, the Advisory Committee urges HCFA to work with stakeholders, including consumers, outpatient departments and manufacturers to capture actual utilization and billing data to be used to establish a permanent payment system for blood derivatives administered in outpatient settings.

5. Recognizing the significant economic issues currently affecting the blood system, the Advisory Committee seeks to review the role of various considerations in decision making related to new and existing blood safety measures.


Each of the above recommendations was approved unanimously, without abstentions, by the Advisory Committee.