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.
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