78R13247 CME-D

By:  Raymond                                                    H.C.R. No. 233



CONCURRENT RESOLUTION
	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 78th Legislature of the State of Texas 
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 Legislature hereby encourage 
facilities that collect plasma for fractionation into plasma 
therapeutic proteins to become certified under the International 
Quality Plasma Program, encourage manufacturers that fractionate 
source plasma to become certified under the Quality Standards of 
Excellence Assurance and Leadership 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.