Location:
MEDICAL CARE;
Scope:
Connecticut laws/regulations; Federal laws/regulations;

OLR Research Report


July 12, 2012

 

2012-R-0302

BLOOD DONATIONS

By: James Orlando, Associate Analyst

You asked if (1) other states allow organizations other than the Red Cross to manage blood banks; (2) why the Red Cross is the only organization in Connecticut that does so; and (3) whether any organizations accept blood donations for paid therapeutic reasons.

SUMMARY

Most states, including Connecticut, allow organizations other than the Red Cross to conduct blood donations and operate blood banks. In some states, such as Connecticut and Massachusetts, the Red Cross is the primary organization managing the blood supply. In others, such as New York and Rhode Island, other organizations serve that role.

Across the country, most blood donations are collected by either the (1) American Red Cross or (2) community blood centers affiliated with America's Blood Centers. Some hospitals also collect blood through their own donation programs.

In Connecticut, the organization that oversees blood donations is the Red Cross. We contacted several hospitals and none indicated that they conduct independent blood drives. Some hospitals conduct blood drives through the Red Cross. The website for the Connecticut Region of the Red Cross is http://www.ctredcross.org. We have been unable to determine why there are no blood collection facilities in the state other than the Red Cross. State regulations specify requirements for blood collection facilities and do not preclude other organizations from operating such a facility.

The Red Cross only accepts donations on a volunteer basis. Their policy is to refuse to accept donations that were given for other than altruistic reasons. This includes situations where people donate as part of treatment for a medical condition such as hemochromatosis (iron overload disorder) rather than pay for a therapeutic phlebotomy.

Some organizations do accept blood donations by people with hemochromatosis— for example, the Rhode Island Blood Center and the New York Blood Center. Information on the latter organization's program for hemochromatosis patients is available on their website: http://www.nybc.org/Hemochromatosis-Phlebotomy.do?sid0=61&page_id=277.

The federal Food and Drug Administration (FDA), which has primary responsibility for regulating the nation's blood supply, allows blood donations by people with hemochromatosis. Generally, the FDA (1) requires the blood to be labeled with the donor's disease status (21 C.F.R. 640.3(d)) and (2) allows a person to donate more than once in eight weeks only after a physical examination and a physician's certification of health (21 C.F.R. 640.3(f)). However, the FDA considers requests for variances to the labeling and physician examination requirements. More information is available on the FDA's webpage: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm076719.htm#r4.

BLOOD COLLECTION NATIONALLY AND IN THE NORTHEAST

The Red Cross provides approximately 45% of the nation's blood supply. According to its 2011 Annual Report, in 2011, 3.6 million people across the country donated blood through the Red Cross, for a total of 6.1 million units of blood that were processed into 9.1 million blood products for transfusion (http://www.redcross.org/www-files/flash_files/AnnualReport/2011/AnnualReport.pdf).

America's Blood Centers (ABC) is a network of non-profit community blood centers with over seventy member organizations across the country (none are located in Connecticut). According to ABC, their member organizations collectively provide about 50% of the nation's blood supply. According to ABC's website, ABC's member organizations (including one organization in Quebec) collect more than 8 million units of blood, which are processed into nearly 10 million blood products. Their website is http://www.americasblood.org/.

As in Connecticut, the Red Cross is the primary source for storage and distribution of blood donations in Massachusetts, although some hospitals also have blood donation systems. In addition to their own donation systems, Massachusetts hospitals may get their blood from the Red Cross or from other sources out of state.

The Red Cross is also the primary organization handling blood donations in Maine, New Hampshire, and Vermont. Information about donation in these states is available at http://www.redcrossblood.org/nne.

In Rhode Island, the non-profit Rhode Island Blood Center is the sole supplier of blood and blood products for hospitals in the state. The center also serves hospitals in Connecticut and Massachusetts. The center is an ABC member. More information about the center is available on their website: http://www.ribc.org/full/Default.aspx.

In New York, the primary blood supplier is the non-profit New York Blood Center. According to its website, the center is one of the largest community-based, non-profit blood collection and distribution organizations in the country, annually providing almost one million blood components to nearly 200 hospitals throughout New York City, New Jersey, Hudson Valley, Long Island, and parts of Connecticut and Pennsylvania. The center is also an ABC member. The center's website is http://www.nybc.org/index.jsp.

In Pennsylvania, both the Red Cross and community blood centers collect blood donations in various regions of the state. For example, the Central Pennsylvania Blood Bank (CPBB), an ABC member, operates 12 donor centers and conducts blood drives. The CPBB is the sole blood provider to 15 hospitals in the state. Their website is http://www.cpbb.org/. For another example, the Northeastern Pennsylvania Region of the Red Cross serves that region of the state (http://www.redcrossblood.org/nepa).

BLOOD SUPPLY REGULATIONS AND STANDARDS

Nationally, the FDA Center for Biologics Evaluation and Research (CBER) has principal responsibility for ensuring the safety of the nation's blood supply. It sets standards for collecting, processing, and using blood and blood products. More information is available on their website: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/RegulationoftheBloodSupply/default.htm. The federal Centers for Medicare and Medicaid Services (CMS) also sets standards for the clinical laboratories and blood banks that provide services it funds.

In Connecticut, blood collection facilities must also register with, and are inspected by, the Department of Public Health (DPH). Registrations must be renewed every two years. Mobile or temporary blood collection facilities (e.g., a Red Cross blood drive in a church or school) do not need to register with DPH if the organization operating the facility is registered (Conn. Agency Regs. 19a-36-A47 to A55). The regulations are attached to this report.

The American Association of Blood Banks (AABB), a professional organization established by the medical and laboratory communities, also sets standards for and accredits blood banks and transfusion services. Information about the AABB accreditation process is available on their website: http://www.aabb.org/sa/Pages/default.aspx.

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