PECULIARITIES OF LEGISLATIVE REGULATION OF CORD BLOOD BANKING IN USA

In 1982, the American scientist H. Boksmeer made a revolutionary announcement that cord blood is a rich source of hematopoietic stem cells and can be used instead of bone marrow in hematologic transplantology. 6 years later, in 1988, Prof. Eliane Gluckman in France (Paris) performed the world’s first cord blood transplant to the American boy suffering from Fanconi anemia. And 4 years later — in 1992 in the USA the world’s first cord blood bank was created.

us_hhsNowadays more than 35,000 transplants of cord blood hematopoietic stem cell are performed worldwide and cord blood banking emerged as a separate biomedical industry with an extremely rapid rate of development. Currently cord blood banks of the world preserve more than 2 million cord blood samples, of which more than 1 500 000 — are stored in the banks of a family type, and about 600 000samples — in public banks, funded by the state.

Banking of umbilical cord blood in the United States is regulated by law. In 2005, the Institute of Medicine (IOM) issued a comprehensive report to Congress on cord blood banking. The report contains clear recommendations that health care professionals should provide all expectant parents with fair and balanced education on cord blood preservation prior to labor and delivery, thereby enabling families to make an informed decision regarding their options: preserve the stem cells for future family use, donate the cells for public use or research, or dispose of the cord blood.

Following the guidance of the IOM Study, the Stem Cell Therapeutic and Research Act of 2005 (P.L. 109-129) was enacted. The federal legislation authorized funding for banking 150,000 new units of high quality and genetically diverse cord blood units and directed the Department of Health and Human Services (HHS) to contract with public cord blood banks to assist in collection. HHS through the Health Resources and Services Administration (HRSA) established the National Cord Blood Inventory (NCBI) program, which supports the banking of stem cells derived from umbilical cord blood for use in the treatment of patients and research. These cord blood units are made available to physicians and patients for unrelated blood stem cell transplants through the C.W. Bill Young Cell Transplantation Program.

The Stem Cell Therapeutic and Research Reauthorization Act of 2010 (P.L. 111-264) amended the number of cord blood units that are to be available from the NCBI from a total of 150,000 to «at least» 150,000 cord blood units and placed new emphasis on actions such as exploring innovations in cord blood collection and increasing the number of collection sites. The act authorized additional federal funds to support the growth of publicly available cord blood units and in meeting the inventory goal to increase the genetic diversity of the supply to improve the probability that all racial and ethnic groups might find a suitable cord blood unit. The statute also required the Government Accountability Office to report on efforts to increase cord blood unit collection for the NCBI.

The IOM Study has helped to guide health policy at the state level as well. To date, 28 states have passed some form of cord blood education legislation, which represents 78% of the total annual US births. The majority of states follow the IOM recommendations. Several other states are in various stages of developing similar legislation to help inform health care providers and expectant parents of all medically appropriate options for preserving cord blood stem cells.

States with Cord Blood Legislation
Arizona

As of 2007, health care professionals must inform a pregnant patient in her second trimester of all medically appropriate cord blood options. The Arizona Department of Health Services has developed a brochure, including the benefits of cord blood collection to the newborn, biological family, and non-related individuals.

Arkansas

As of 2008, health care professionals are encouraged to educate pregnant patients regarding all medically appropriate cord blood options. The statute also establishes a program where taxpayers can contribute a portion of their state income tax refunds towards a statewide cord blood banking program at the University of Arkansas for Medical Sciences (UAMS).

California

As of 2008, health care professionals are encouraged to educate pregnant patients regarding all medically appropriate cord blood options. The California Department of Public Health provides information regarding cord blood banking in the California Prenatal Screening Program brochure.

PrintIn 2010, California’s state government created the Umbilical Cord Blood Collection Program (UCBCP), administered by UC Davis Health System. The statewide public cord blood banking program is funded through a $2 fee on certified copies of birth certificates.

Colorado

As of 2008, health care professionals are encouraged to educate pregnant patients regarding options for donating to a public cord blood bank. With support from the Checkoff Colorado donations in tax years 2008-2010, the University of Colorado Cord Blood Bank established a Statewide Umbilical Cord Blood Collection program wherein qualified Colorado residents can now donate their babies’ umbilical cord blood.

Connecticut

As of 2009, health care professionals must inform a pregnant patient in her third trimester of all medically appropriate cord blood options.
Legislation enacted in 2011 created an eight-member Connecticut Umbilical Cord Blood Collection Board to establish a state umbilical cord blood collection program.

Florida

As of 2011, health care professionals are encouraged to educate pregnant patients regarding all medically appropriate cord blood options. Florida explicitly endorses the use of patient education resources developed by the Parent’s Guide to Cord Blood Foundation.

Georgia

As of 2009, health care professionals must inform pregnant patients, within 30 days from the beginning of the third trimester, of all medically appropriate cord blood options. Additionally, the statute establishes the Newborn Umbilical Cord Blood Bank and creates the Georgia Commission for Saving the Cure.

Illinois

louisianaAs of 2008, health care professional are encouraged to educate pregnant patients, before the third trimester, regarding all medically appropriate cord blood options. The Illinois Department of Public Health prepares and distributes written materials containing standardized objective information about cord blood banking that is sufficient to allow expectant parents to make an informed decision.

Additionally, legislation enacted in 2007 directs the Illinois Department of Public Health to establish a network of public cord blood banks and creates a committee to advise the Department concerning the administration of the cord blood stem cell bank network.

Kansas

As of 2007, health care professionals are encouraged to educate pregnant patients, prior to or during the third trimester, regarding options for donating to a public cord blood bank.

Louisiana

As of 2008, the Louisiana Department of Health and Hospitals are required to promote awareness of the potential benefits of cord blood banking. The department will develop an outreach campaign via written materials, brochures, the Internet, and public service announcements to promote cord blood banking awareness. Also, the legislation calls for educating medical professionals and establishing a toll free number for information on all cord blood banks serving the state. Implementation is dependent on funding.

Maryland

As of 2006, health care professionals are encouraged to educate pregnant patients regarding options for donating to a public cord blood bank. The Maryland Department of Health and Mental Hygiene distributes educational materials on public donation for obstetricians and hospitals with obstetrical services to provide to their pregnant patients.

Massachusetts

As of 2005, all hospitals must inform pregnant patients, within 30 days from the commencement of the third trimester, regarding options for donating to a public cord blood bank. Additionally, the Massachusetts Department of Public Health administers a program that encourages health care professionals to educate pregnant patients regarding all medically appropriate cord blood options.

Michigan

As of 2007, health care professionals are encouraged to educate pregnant patients, prior to the commencement of the third trimester, regarding all medically appropriate cord blood options. Upon appropriation of sufficient funding, the Michigan Department of Health is charged with developing and disseminating educational materials and related information to enable the public to make informed decisions about the utilization of cord blood stem cells.

Mississippi

As of 2014, the Mississippi Department of Health is authorized to promote public awareness of the potential benefits of cord blood banking. Upon appropriation of sufficient funding, the Mississippi Department of Health is charged with developing educational and outreach programs and materials aimed at healthcare professionals.

Missouri

As of 2011, health care professional are encouraged to educate pregnant patients, prior to the commencement of the third trimester, regarding all medically appropriate cord blood options. Missouri explicitly endorses the use of patient education resources developed by the Parent’s Guide to Cord Blood Foundation.

New Jersey

1221As of 2008, health care professionals must inform a pregnant patient as early as possible, preferably in the first trimester, of all medically appropriate cord blood options. The legislation also includes a provision for the New Jersey Department of Health and Senior Services to make available an educational brochure.

In 2005, New Jersey became the first state in the nation to create a publicly funded cord blood and placental stem cell bank and education program. Community Blood Services oversees all operations of the New Jersey Cord Blood Bank (NJCBB).

New Mexico

As of 2006, health care professionals must inform pregnant patients, following the commencement of the third trimester, regarding options for donating to a public cord blood bank.

North Carolina

As of 2009, health care professionals are encouraged to educate pregnant patients as early as possible of all medically appropriate cord blood options. The legislation requires the North Carolina Department of Health to provide expectant parents and providers with education resources about cord blood stem cells and the options for preserving them.

North Dakota

As of 2012, health care professionals are encouraged to educate pregnant patients regarding all medically appropriate cord blood options. North Dakota explicitly endorses the use of patient education resources developed by the Parent’s Guide to Cord Blood Foundation.

Ohio

As of 2010, health care professionals are encouraged to educate pregnant patients, prior to the commencement of the third trimester, regarding all medically appropriate cord blood options. Ohio explicitly endorses the use of patient education resources developed by the Parent’s Guide to Cord Blood Foundation.

Oklahoma

As of 2008, the Oklahoma State Department of Health is required to establish a program to educate pregnant patients on cord blood banking. The program must provide patients sufficient information to make an informed decision on whether or not to donate to a public bank or store with a private bank. The legislation mandates that all physicians and hospitals licensed in Oklahoma inform each pregnant patient under their care, within 30 days from the commencement of the third trimester, of the opportunity to donate to the public umbilical cord blood bank established by the legislation.

Pennsylvania

As of 2008, health care professionals must inform expectant parents, prior to the end of the second trimester, of all medically appropriate cord blood options. The legislation requires the Pennsylvania Department of Health to make available an online brochure that providers can give to their patients.

Rhode Island

As of 2008, health care professionals must inform expectant parents, following the commencement of the second trimester, of all medically appropriate cord blood options.

Tennessee

As of 2010, health care professionals are encouraged to educate expectant parents, prior to the commencement of the third trimester, regarding all medically appropriate cord blood options. Tennessee explicitly endorses the use of patient education resources developed by the Parent’s Guide to Cord Blood Foundation.

Texas

As of 2008, the Texas Health and Human Services Commission is mandated to promote public awareness of all medically appropriate cord blood options via a brochure. The brochure must be provided by health care professionals to pregnant women before the third trimester, or as soon as reasonably feasible.

Virginia

As of 2010, health care professionals must inform expectant parents, prior to the commencement of the third trimester, regarding all medically appropriate cord blood options. Virginia explicitly endorses the use of patient education resourcesdeveloped by the Parent’s Guide to Cord Blood Foundation.

Washington

As of 2010, health care professionals are encouraged to inform expectant parents, prior to the commencement of the third trimester, regarding all medically appropriate cord blood options. The law ensures that expectant parents have greater access to cord blood information prior to the third trimester of pregnancy to help them more readily arrange for private cord stem cell storage or public donation as alternatives to discarding cord blood as medical waste.

Wisconsin

As of 2005, health care professionals must inform expectant parents, prior to the 35th week of pregnancy, of options for donating to a public cord blood bank.

Source: http://www.cordblood.com/ and data of the Association of Cryobanks