The American Red Cross (ARC) continues to stumble along in the Blood Services arena, apparently unable to right the listing ship over the last 16 years since the imposition of the Consent Decree between the Federal District Court, The Food & Drug Administration and the American Red Cross in 1993.

As we approach the 2010, ARC is also facing serious issues with components of its work force. Allegations of unfair labor practices have been leveled against Red Cross in the current dispute with unions representing ARC employees. Over the last four years Red Cross has been rocked by labor disputes from Oakland, California to the current situation in Philadelphia and New Jersey. Some workers have expressed concerns regarding ARC labor practices and the impact this can have on safety at a given ARC blood collection facility.

The ARC has, for sixteen years, showed an apparent lack of will or motivation to put its Blood Services house in order and end the need for an ongoing consent decree. Each year when the Committee of Ten Thousand looks at the upcoming year, we have hoped for serious change at the highest levels of the American Red Cross regarding the operations of its Blood Services. Yet as we speak ARC workers are on strike in New Jersey and Philadelphia are on strike, including bloodmobile drivers and Phlebotomists and according to the AFL is indicative of ongoing unfair labor practices by ARC.

The American Red Cross remains the largest supplier of blood in the United States, collecting over 40 percent of the nation’s blood. According to a recent report on these matters, the sale of donated blood, generating roughly 2 billion dollars in revenues, accounts for more than two-thirds of the Agency/s overall revenues which surpassed 3.2 billion dollars in 2008 (“Labor Relations at the American Red Cross and its Impact on Employee and Donor Safety” by Philip Dine, for the National Workers’ Rights Board).

The AIDS/Blood epidemic resulted in a higher degree of national attention being focused on the safety of the Nation’s blood supply and those who are tasked to operate and manage the system. The widespread HIV/AIDS infection of the hemophilia community and the unknown numbers of transfusion associated HIV/AIDS transmissions represented a complete breakdown of the federal regulatory structure for blood/blood products.

By the late 1980 and early 1990s calls for regulatory change and federal government action began to have impact. Yet some sectors of the American blood community have clearly failed to effectively order their procedural and operational house.

In December of 2001, eight years ago, the FDA petitioned the federal court to hold the American Red Cross in contempt of the consent decree and to increase the potential fines that could be levied in the future.

In September of 2006 the Food & Drug Administration levied an additional $4.2 million in fines for repeated failures of the ARC in handle and collect blood supplies properly. They also cited ARCs ongoing failure to protect the safety of our nation’s blood supply including “failure to ask appropriate questions of potential donors and failure to follow testing procedures.” The additional fines were connected, in part, to the recall of 10.000 units of blood between 2003 and 2005, and the failures in standard operating procedures, SOPs, regarding donor questioning and proper testing.

In February 2008, the FDA fined the Red Cross $4.6 million for distributing 4,094 unsuitable blood products. In June 2008, the Red Cross was fined $1.7 million for improperly processing six pints of red blood cells that were transfused into three patients, none of whom was believed to be harmed. More broadly, though, there is reportedly no reliable record of whether recipients were harmed by the improperly collected blood. Even before these latter two fines, the FDA commissioner warned Red Cross directors in January 2008 that they could face criminal prosecutions for their continuing inability to bring the organization into compliance with the consent decree.

While these ongoing compliance failures at the ARC have not resulted in any serious health problems, they are indicative of potential breakdowns that could pose threats to the end users of blood and blood products. From a landscape view of American Red Cross Blood Services, it is indicative of a climate of inaction and a lack of will to ensure compliance at every level of the collection, handling and shipment of blood and blood products. How else do we explain sixteen years of a federal consent decree and no resolution in sight? What will it take for the American Red Cross to move beyond this shameful chapter in its illustrious history of service and support?

COTT was surprised recently when we began to look at the history of relations between the American Red Cross and its workers. Given that blood collection, processing and handling is not your everyday service or product delivery. It is an undertaking that has national importance and significance, especially when one considers that over 40 percent of the blood collected in the US is done so by the American Red Cross.

From 1996 through 2007, the American Red Cross was charged with 212 unfair labor practice violations by the National Labor Relations Board. The Federal Mediation and Conciliation Service intervened 152 times in labor- management conflicts at the Red Cross between 1998 and 2007. Those disputes have involved Red Cross management and the various unions representing the organization’s employees, including the International Brotherhood of Teamsters (IBT); Service Employees International Union(SEIU); Communications Workers of America (CWA); American Federation of State, County and Municipal Employees (AFSCME); Office and Professional Employees International Union (OPEIU); United Auto Workers (UAW); United Steelworkers (USW); International Union of Operating Engineers (IUOE); Laborers’ International Union of North America (LIUNA); and the United Food and Commercial Workers (UFCW).

Several bitter labor-management disputes have rocked the Red Cross in recent years. For example, four East Bay blood centers in the Oakland, California area were closed in late November 2006 because of a strike by nurses and lab technicians, and some East Bay blood drives were canceled. The regional Red Cross spokeswoman acknowledged that blood supplies in the area would be affected, especially because of the difficulty obtaining sufficient amounts of blood between Thanksgiving and New Year’s. The employees involved had been working for nine months without a contract, with a key sticking point being their request for more advance notice for changes in shift scheduling, so they could plan for family responsibilities.

On the other side of the country, American Red Cross blood collectors serving New Hampshire and southeastern Vermont voted in early November 2007 to go on strike, after the blood collectors’ union had gone 15 months without reaching a contract since its formation in August 2006 and after, according to the union’s spokesman, the workers sought increased personnel to ensure safety at blood drives but the Red Cross “just refused to even discuss it.” Red Cross officials declined at the time to publicly discuss the terms of the proposed contract. The day before the day the strike was to begin, a last-minute ratification vote by workers averted a strike.

The mix of poor labor relations, high turnover and an inability to meet operating standards leaves us troubled about the ARC and the current situation. We call on the FDA and the federal District Court to ensure that the American Red Cross gets its blood collection and handling house in order. We also call on the American Red Cross to demonstrate the internal will necessary to accomplish the objectives as mandated in the consent decree.

– By Corey S. Dubin, president, COTT

THE BLOOD brain barrier is generally considered an obstacle to delivering therapies from the bloodstream to the brain. However, University of Iowa researchers have discovered a way to turn the blood vessels surrounding brain cells into a production and delivery system for getting therapeutic molecules directly into brain cells.

RESEARCHERS IN Malaysia have identified key laboratory and clinical features of an emerging new form of malaria infection. The research, funded by the Wellcome Trust, confirms the potentially deadly nature of the disease.

NHF HAS developed a policy position on the U.S. Food and Drug Administration approval process for biosimilars.  Biosimilars and follow-on biologics are analogous to generic pharmaceuticals, but for biologics not drugs.

SAFE BLOOD for Africa Foundation and Hema-Quebec have announced the signing of a formal joint agreement to provide even stronger support for blood safety and donor programs in Africa.

A new study in Britain indicates that heart-bypass patients who receive blood transfusions are twice as likely to develop an infection after their operation. They were also five times more likely to die in hospital and three times more likely to die within a month of the surgery as patients not given extra blood.
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The possibility that unsafe blood transfusions can spread the HIV virus remains an important reason to improve blood safety. Internationally, the US government through, its Pepfar program, provided approximately $92.4 million for medical transmission prevention activities in the focus countries, or 2.9 percent of program funds.

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PanGenera(R) Detection (PGD) technology, a rapid diagnostic test used to detect bacterial contaminants in donated blood platelets, will now be more widely marketed under a new agreement with Fenwal Inc., a global medical technology company focused on improving blood collection, separation, safety and availability.

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The American Red Cross says the Southeast’s blood supply is critically low and urges all donors to give as soon as they can, especially those with blood types O negative, B negative and A negative, which are most needed now.
The Red Cross typically has a summer blood shortage because fewer blood drives are being held. In its Southern Region, the Red Cross must collect 1,200 units of blood each weekday to meet the needs of hospitals.

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The long, troubled push to develop artificial blood suffered another blow as a company that has led the charge announced it was shutting down. Northfield Laboratories in Evanston, Illinois, said on Friday that it has “terminated the employment” of virtually everyone working there, after the U.S. Food and Drug Administration (FDA) refused to allow its product on the market.

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Bayer HealthCare has announced today the recipients of the 2009 World Federation of Hemophilia’s International Hemophilia Nursing Fellowship. This Bayer-supported initiative provides hemophilia education and training to nurses in developing countries – areas where hemophilia-trained healthcare professionals are in short supply. Three recipients were selected out of a pool of 59 applications from eight countries.

“Worldwide, about 70 percent of people with hemophilia go undiagnosed, and 75 percent do not receive adequate treatment, the majority of whom live in developing countries,” said Mark Skinner, president, World Federation of Hemophilia (WFH).