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For Immediate Release: June 17, 2010
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
The FDA announced today that the American Red Cross has been fined $16 million for prior failures to comply with Federal laws and regulations related to the collection and manufacture of blood products.
Despite the compliance failures, FDA found no evidence that the Red Cross violations endangered any patients and the blood supply is believed to be safe. Multiple layers of safeguards are in place to protect and enhance the safety of blood products. However, these types of violations decrease the assurance that blood products manufactured by American Red Cross will continue to be safe and have the potential to compromise the safety of the blood supply.
The FDA assessed fines totaling $16.18 million - $9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma and platelets.
FDA is encouraged by recent efforts made by the Red Cross leadership and will work closely with them to achieve full compliance. The FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues that have contributed to these violations.
In October 2009, the agency notified the American Red Cross that FDA inspections conducted during fiscal years 2008 and 2009 revealed violations that included failure to identify problems that occur during manufacturing and failure to adequately investigate identified problems.
The fines announced today were assessed under an amended 2003 consent decree that outlines requirements for the American Red Cross to ensure safety of the nation's blood supply.
The original 1993 decree was amended in 2003 to allow the FDA to impose significant fines for failure to comply with agency regulations and provisions designed to ensure the safety of the nation's blood supply.
Since 2003, the American Red Cross has made progress addressing some of its quality issues, including standardizing procedures, upgrading its National Testing Laboratories, and increasing oversight of the organization. However, to fully comply with federal regulations and consent decree provisions, the American Red Cross must make swift, additional progress on all of the issues the FDA has identified.
The agency has previously sent 12 similar letters to the American Red Cross and imposed a total of more than $21 million in fines under terms of the amended 2003 consent decree.
The American Red Cross is one of several organizations that is responsible for the nation's blood supply.
For more information:
To access the adverse determination letters
HPAE Local 5103 has joined with other unionized Red Cross workers from across the country forming a national union coalition to protect donors, keep the blood supply safe and protect Red Cross workers' rights on a local and national level.
The coalition consists of union members represented by AFL-CIO unions AFSCME, CWA, OPEIU, UAW and USW and several unaffiliated unions including the IBT, UFCW and SEIU.
On June 2, seven coalition unions who are currently in negotiations or working with expired contracts went on limited 1 to 3 day strikes to protest unfair labor practices, safe staffing issues and health insurance. As of now, the strikes are over and we will await negotiation updates.
Collectively we will protect our donors and our rights.
If you have any questions or would like to get more involved, please contact your Local officers or your HPAE Staff Representative Jeff Hayden at (856) 663 – 0300 or jhayden@hpae.org
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Unions representing Red Cross workers across the U.S. have joined together to form a coalition that is fighting to protect donors, keep blood safe, and demand respect for Red Cross workers.

Demanding Respect for Red Cross Workers:
Coalition Launches New Website
Click the image above to read Labor Relations of the American Red Cross and its Impact on Employee and Donor Safety
Know your rights regarding unpaid leave due to domestic and sexual violence:
Please disregard the expiration date on this document.
Click here to read a summary of rules employer's must follow regarding leave for survivors of domestic and sexual violence
Hello Everyone,
I’d like to greet all of our new members, and introduce myself, as well as say hello to everyone who already knows me. I’m Judy Merkowsky, and I’m a co-president of our Local. I want to remind everyone of a couple of things. First and foremost, NEVER go downtown for discipline without Representation. Even if you know you committed an infraction or made an error, it’s still in your best interest to take someone with you. A Rep will witness what’s going on, and take notes. In the event that the incident or discipline comes up again, or is referenced later, the Rep can serve as a resource for what occurred at the original meeting. Additionally, the Rep can make sure that the meeting remains “civilized” and that the topic doesn’t extend beyond the immediate cause for discipline. If you feel the discipline is being issued wrongly, the Rep will be able to begin the grievance process. A Rep is generally not going to be able to prevent the discipline from being issued, but rather will witness the discipline and file an appropriate grievance.
If you’re called for an “investigation” and are suspicious or concerned that there may be a discipline involved, never hesitate to invoke your “Weingarten Rights”. These rights are federally protected (see the article below).
As always, I encourage you all to read and understand your contract. It is in place to protect and benefit you. The Officers and Reps of the Local are available to assist you and answer any questions you may have. Don’t hesitate to call us.
We encourage you to attend Membership Meetings, too. An involved membership means a healthy Local, and is our best weapon to keep management from taking advantage of us. Keep in touch.
Judy
EMPLOYEE'S RIGHT TO UNION REPRESENTATION
The rights of unionized employees to have present a union Representative during investigatory interviews were announced by the U.S. Supreme Court in a 1975 case (NLRB vs. Weingarten, Inc. 420 U.S. 251, 88 LRRM 2689). These rights have become known as the Weingarten rights.
Employees have Weingarten rights only during investigatory interviews. An investigatory interview occurs when a supervisor questions an employee to obtain information which could be used as a basis for discipline or asks an employee to defend his or her conduct.
If an employee has a reasonable belief that discipline or other adverse consequences may result from what he or she says, the employee has the right to request union Representation. Management is not required to inform the employee of his/her Weingarten rights; it is the employees responsibility to know and request.
When the employee makes the request for a union Representative to be present management has three options:
1. it can stop questioning until the Representative arrives.
2. it can call off the interview or,
3. it can tell the employee that it will call off the interview unless the employee voluntarily gives up his/her rights to a union Representative (an option the employee should always refuse.)
Employers will often assert that the only role of a union Representative in an investigatory interview is to observe the discussion. The Supreme Court, however, clearly acknowledges a Representative's right to assist and counsel workers during the interview. The Supreme Court has also ruled that during an investigatory interview management must inform the union Representative of the subject of the interrogation. The Representative must also be allowed to speak privately with the employee before the interview. During the questioning, the Representative can interrupt to clarify a question or to object to confusing or intimidating tactics. While the interview is in progress the Representative can not tell the employee what to say but he may advise them on how to answer a question. At the end of the interview the union Representative can add information to support the employee's case. It is extremely important that all members are aware of their Weingarten rights and use them. Union Representation in this context is crucial to ensure the employee is treated fairly and not harassed by management.
Click here to read Local 5103's May 2008 - May 2011 Contract
Co-Presidents - Judy Merkowsky (Pros), Renee Conyers (Technical)
Grievance Chairpersons - Tina Mills
Secretary/Treasurer - Jerry Costello
Health & Safety - Brenda Brandon
HPAE Staff Rep - Jeffrey Hayden (856) 663-0300 ext. 316
HPAE Support Staff - Lorraine Loiacono (201) 262-5005 ext. 123
