HF 1598

as introduced - 83rd Legislature (2003 - 2004) Posted on 12/15/2009 12:00am

  1.1                             A resolution
  1.2             urging adoption of quality and safety standards for 
  1.3             the collection and processing of human plasma. 
  1.4      
  1.5      WHEREAS, hundreds of thousands of people in the United 
  1.6   States, including the state of Minnesota, depend on protein 
  1.7   therapies derived from human plasma, "plasma therapies," to 
  1.8   treat serious and life-threatening diseases and conditions such 
  1.9   as hemophilia, primary immune disorder, Alpha-1 Antitrypsin 
  1.10  deficiency (Alpha-1), Rh Negative blood incompatibility, shock, 
  1.11  and burns; and 
  1.12     WHEREAS, assuring the continued quality and safety of 
  1.13  plasma therapies is a top priority of patients, public health 
  1.14  authorities, and the plasma collection and fractionation 
  1.15  industry; and 
  1.16     WHEREAS, the plasma industry and its global trade 
  1.17  association has developed the Quality Standards of Excellence 
  1.18  Assurance and Leadership (QSEAL) and International Quality 
  1.19  Plasma Program (IQPP); and 
  1.20     WHEREAS, these standards currently represent the highest 
  1.21  reasonably attainable quality and safety standards for human 
  1.22  source plasma used in the processing of plasma protein 
  1.23  therapies; and 
  1.24     WHEREAS, the QSEAL standards include: 
  2.1      (1) strict criteria for the selection of qualified donors, 
  2.2   including the requirements that the donor successfully pass a 
  2.3   minimum of two separate health screenings and two separate 
  2.4   validated laboratory tests before any donation can be used; 
  2.5      (2) the use of a 60-day inventory hold and the requirement 
  2.6   that if new information is received indicating that a donor is 
  2.7   no longer qualified, previous donations from that donor held in 
  2.8   inventory are required to be destroyed; 
  2.9      (3) the use of state-of-the-art nucleic acid amplification 
  2.10  Technology (NAT to detect any potential presence of human 
  2.11  immunodeficiency virus (HIV), Hepatitis B virus (HBV), or 
  2.12  Hepatitis C virus (HCV), or any potential presence at critical 
  2.13  levels of parvovirus B19; and 
  2.14     (4) the requirement that plasma used to produce plasma 
  2.15  therapies be collected at centers that adhere to, and are judged 
  2.16  by, specific strict viral marker standards; and 
  2.17     WHEREAS, QSEAL and IQPP standards provide an extra margin 
  2.18  of safety beyond federal and state regulatory requirements for 
  2.19  the collecting, processing, and testing of human plasma; and 
  2.20     WHEREAS, QSEAL and IQPP standards have helped drive the 
  2.21  adoption of enhanced and consistent safety standards for plasma 
  2.22  collection and processing; and 
  2.23     WHEREAS, it is important to further increase public 
  2.24  awareness of the value of donating blood and plasma, as well as 
  2.25  an appreciation of the safety of plasma therapies and the 
  2.26  processes by which that safety is assured; NOW, THEREFORE, 
  2.27     BE IT RESOLVED by the House of Representatives of the State 
  2.28  of Minnesota that the IQPP and QSEAL certification programs are 
  2.29  important ways to ensure that only the highest quality plasma is 
  2.30  collected and used for processing of plasma-derived therapeutic 
  2.31  proteins. 
  2.32     BE IT FURTHER RESOLVED that all facilities which collect 
  2.33  blood and plasma for fractionation into plasma therapeutic 
  2.34  proteins are strongly encouraged to become certified under the 
  2.35  IQPP program, and processors which fractionate source plasma are 
  2.36  strongly encouraged to become certified under the QSEAL program. 
  3.1      BE IT FURTHER RESOLVED that entities which collect plasma 
  3.2   recovered from whole blood should implement a quality and safety 
  3.3   standards certification program comparable to QSEAL and IQPP. 
  3.4      BE IT FURTHER RESOLVED that health care professionals and 
  3.5   health plans that purchase or provide plasma proteins for 
  3.6   patient care should utilize therapeutics that employ rigorous 
  3.7   quality systems, as exemplified by the IQPP and QSEAL 
  3.8   certification programs, which are aimed at assuring the highest 
  3.9   quality and safety of plasma donations from which plasma 
  3.10  therapies are derived.