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78R16808 CME-D
By: Carona S.R. No. 893
R E S O L U T I O N
WHEREAS, Each year, thousands of Texans depend on plasma
protein therapeutics as treatment for life-threatening conditions
including shock, severe burns, immune deficiency disorders such as
alpha-1 antitrypsin deficiency, and hemophilia and other blood
disorders; and
WHEREAS, The treatments for these conditions and diseases
rely on the safe collection and processing of human source plasma;
to ensure the continued quality and safety of these critical
therapies, the plasma industry and its global trade association
have developed the Quality Standards of Excellence Assurance and
Leadership (QSEAL) Program and the International Quality Plasma
Program (IQPP); and
WHEREAS, The QSEAL and IQPP certification standards include
strict criteria for the selection of qualified donors, the use of a
60-day inventory hold with provisions for destruction of certain
plasma on post-donation information indicating a donor is no longer
qualified, the use of state-of-the-art nucleic acid amplification
technology to screen donations for human immunodeficiency virus
(HIV), hepatitis B and C, and parvovirus B19, and the requirement
that plasma used to produce plasma therapies be collected from
centers that adhere to strict viral marker standards; and
WHEREAS, The QSEAL and IQPP certification standards go well
beyond state and federal regulatory requirements to ensure the
integrity of human source plasma for the production of plasma
protein therapies and encourage use of the latest technological
advancements in safety control; these standards have helped drive
public health initiatives nationwide and are invaluable to
successful treatments for a variety of life-threatening illnesses
and conditions; now, therefore, be it
RESOLVED, That the Senate of the 78th Texas Legislature
hereby express support for the International Quality Plasma Program
and the Quality Standards of Excellence Assurance and Leadership
Program as important standards of certification that ensure that
only the highest quality plasma is collected and used for the
manufacture of plasma-derived therapeutic proteins; and, be it
further
RESOLVED, That the Texas Senate hereby encourage facilities
that collect plasma for fractionation into plasma therapeutic
proteins to become certified under the IQPP program, encourage
manufacturers that fractionate source plasma to become certified
under the QSEAL Program, and encourage health care professionals
and health plans that purchase or provide plasma proteins for
patient care to use products that meet rigorous quality control
standards such as those exemplified by the IQPP and QSEAL
certification programs.