093_HR0418

                                     LRB093 11736 HSS 15595 r

 1                          HOUSE RESOLUTION

 2        WHEREAS, Hundreds of thousands of people  in  the  United
 3    States,  including  the  State of Illinois, depend on protein
 4    therapies derived from human plasma ("plasma  therapies")  to
 5    treat  serious  and  life-threatening diseases and conditions
 6    such  as  hemophilia,  primary   immune   disorder,   Alpha-1
 7    Antitrypsin   deficiency   (Alpha-1),   Rh   Negative   blood
 8    incompatibility, shock, and burns; and

 9        WHEREAS,  Assuring  the  continued  quality and safety of
10    plasma therapies is a top priority of patients, public health
11    authorities, and  the  plasma  collection  and  fractionation
12    industry; and

13        WHEREAS,   The  plasma  industry  and  its  global  trade
14    association have developed the QSEAL  (Quality  Standards  of
15    Excellence  Assurance and Leadership) and IQPP (International
16    Quality Plasma Program) standards  that  currently  represent
17    the   highest   reasonably   attainable  quality  and  safety
18    standards for human  source  plasma  used  in  processing  of
19    plasma protein therapies; and

20        WHEREAS,  These  QSEAL standards include: strict criteria
21    for  the  selection  of  qualified  donors,   including   the
22    requirements  that  the  donor successfully pass a minimum of
23    two separate health screenings  and  two  separate  validated
24    laboratory  tests before any donation can be used; the use of
25    a 60-day inventory hold  and  the  requirement  that  if  new
26    information  is  received  indicating that donor is no longer
27    qualified,  previous  donations  from  that  donor  held   in
28    inventory   are   required   to  be  destroyed;  the  use  of
29    state-of-the-art Nucleic acid Amplification Technology  (NAT)
30    to  detect  any  potential presence of human immunodeficiency
31    virus (HIV), Hepatitis B Virus (HBV), and Hepatitis  C  virus
32    (HCV)  and  any  potential  presence  at  critical  levels of
 
                            -2-      LRB093 11736 HSS 15595 r
 1    parvovirus B 19; and the  requirement  that  plasma  used  to
 2    produce  plasma therapies be collected at centers that adhere
 3    to,  and  are  judged  by,  specific  strict   viral   market
 4    standards; and

 5        WHEREAS,  These QSEAL and IQPP standards provide an extra
 6    margin  of  safety  beyond  federal  and   State   regulatory
 7    requirements  for  the collecting, processing, and testing of
 8    human plasma; and

 9        WHEREAS, These QSEAL and IQPP standards have helped drive
10    the adoption of enhanced and consistent safety standards  for
11    plasma collection and processing; and

12        WHEREAS,  It  is  important  to  further  increase public
13    awareness of the value of donating blood and plasma, as  well
14    as  an appreciation of the safety of plasma therapies and the
15    processes by which that safety is assured; therefore, be it

16        RESOLVED,  BY  THE  HOUSE  OF  REPRESENTATIVES   OF   THE
17    NINETY-THIRD  GENERAL ASSEMBLY OF THE STATE OF ILLINOIS, that
18    the IQPP and QSEAL certification programs are important  ways
19    to  ensure  that only the highest quality plasma is collected
20    and  used  for  processing  of   plasma-derived   therapeutic
21    proteins; and be it further

22        RESOLVED,  That  all  facilities  which collect blood and
23    plasma for fractionation into plasma therapeutic proteins are
24    strongly  encouraged  to  become  certified  under  the  IQPP
25    program, and processors which fractionate source  plasma  are
26    strongly  encouraged  to  become  certified  under  the QSEAL
27    program; and be it further

28        RESOLVED, That entities which  collect  plasma  recovered
29    from  whole  blood  are encouraged to implement a quality and
30    safety standards certification program  comparable  to  QSEAL
31    and IQPP; and be it further
 
                            -3-      LRB093 11736 HSS 15595 r
 1        RESOLVED, That health care professionals and health plans
 2    that purchase and/or provide plasma proteins for patient care
 3    are  encouraged  to utilize therapeutics that employ rigorous
 4    quality  systems,  as  exemplified  by  the  IQPP  and  QSEAL
 5    certification programs,  which  are  aimed  at  assuring  the
 6    highest  quality  and  safety  of plasma donations from which
 7    plasma therapies are derived.