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Features

FDA takes measures to ensure
safety of nation's blood supply

[APRIL 15, 2003]  The Food and Drug Administration announced Friday that the American Red Cross will be undergoing substantial changes in its blood management. The new measures will help ensure the safety of the nation's blood supply. The FDA made it clear that this announcement should not create concern among people receiving or donating blood: "As always, FDA encourages donors to come forward to give blood, which is perishable and often in short supply."

The Red Cross does not supply the blood for our local hospitals. Central Illinois Community Blood Center provides all of the blood and blood products for 12 area hospitals, including those in Lincoln, Hopedale and Springfield. No other organization provides blood in these hospitals.

CICBC is a community-based blood center whose mission is to provide a safe and adequate blood supply for patients in local hospitals in a cost-effective manner. When you donate blood through CICBC, you help to keep a safe and adequate blood supply for your community. You also help keep local medical costs under control.

The Food and Drug Administration announced Friday that the American Red Cross has agreed to substantial revisions in its consent decree with the FDA. The revised consent decree includes financial penalties if, in the future, ARC fails to comply with FDA laws and regulations that are aimed at ensuring the safety of the nation's blood supply.

In the original 1993 consent decree, ARC agreed to establish clear lines of managerial control over a newly established comprehensive quality assurance system in all regions; to enhance training programs; and to improve computer systems, records management, and policies for investigating and reporting problems, including adverse reactions.

The revised consent decree includes many of the same substantive provisions, updated to provide a series of clear deadlines for completing specific requirements of the decree and addressing additional types of violations observed since the original consent decree was signed in 1993. It also includes a comprehensive penalty scheme to address potential future violations.

If ARC fails to comply with blood safety rules and revised decree requirements, FDA can assess penalties up to the following maximum amounts:

--$10,000 per event (and $10,000 per day) for any violation of an ARC standard operating procedure, the law, or consent decree requirement and timeline. Standard operating procedures are written procedures that are designed to help ensure product quality.

--$50,000 for the preventable release of each unit of blood for which FDA determines that there is a reasonable probability that the product may cause serious adverse health consequences or death, as well as $5,000 for the release of each unit that may cause temporary problems, up to a maximum of $500,000 per event.

--$50,000 for the improper re-release of each unsuitable blood unit that was returned to ARC inventory.

--$10,000 for each donor inappropriately omitted from the National Donor Deferral Registry, a list of all unsuitable donors.

During the first year of the decree, penalties will be capped at 1 percent of the gross annual revenues generated by ARC's Biomedical Products and Services (ARC's blood operation). These gross annual revenues are currently $1.924 billion. The cap increases to 2 percent in the second year, 3 percent in the third year and reaches the maximum of 4 percent in the following years.

As in the original 1993 consent decree, ARC has agreed to retain the services of outside consultants to assure quality control. In addition, ARC must reimburse FDA for the costs of all FDA inspections that FDA considers necessary to evaluate ARC's compliance with the decree.

"The new financial penalties in the consent decree create an important new incentive for ARC to improve the processes and controls necessary for making safer blood products," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "I am hopeful that the acceptance of this agreement by ARC's new leadership reflects a new willingness to implement a management culture that expects and achieves good blood safety practices."

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ARC is responsible for approximately 45 percent of the nation's blood supply; other independent community-based blood centers together provide another 45 percent, and hospitals collect most of the remaining 10 percent. Since entering into a consent decree with ARC in 1993, FDA has also reached similar agreements in 1996 with other major blood centers such as the New York Blood Center and United Blood Systems. Those organizations have been able to avoid the chronic recurrence of problems that has characterized the ARC's performance under its 1993 agreement with FDA. In addition, FDA inspections of many other independent blood centers result in fewer significant findings of safety problems, consistent with management practices that consistently support safe blood practices.

This agreement between FDA and ARC [check] today stems from FDA concerns arising from inspections over the past 17 years revealing persistent and serious violations of blood safety rules. One such inspection that raised substantial concerns occurred at ARC headquarters in the spring of 2000.

FDA and ARC began negotiations to amend the consent decree in August 2000. In December 2001, when it appeared that a settlement could not be reached, the government filed a motion to hold ARC in civil contempt for violating the 1993 decree and to amend the 1993 decree.

The court has not ruled on the motion the government filed in 2001. The court strongly encouraged both parties to continue negotiations and to reach a settlement if possible. To that end, both FDA and ARC agreed suspend court proceedings and continue talking. Friday’s agreement resolves the dispute.

FDA has reviewed the results of the most recent inspection of ARC headquarters, which ended in December 2002. The inspection revealed numerous and troubling problems in producing blood products -- including systemic problems such as a lack of management control and quality assurance oversight that could lead to a patient receiving potentially unsafe blood.

For example, ARC failed to correct deviations from the previous inspection; ARC's lack of quality assurance oversight led to the release of unsuitable products; and the lack of ARC's inventory control led to the unknown disposition of blood products. FDA is detailing these concerns under the terms of the 1993 consent decree in a formal letter April 14 to ARC. The letter highlights the need for management changes to promote a culture of safety at ARC.

With the legal issues now resolved and when the revised decree has been entered by the court, FDA expects that ARC will be able to concentrate fully on responding to the agency's concerns about blood safety. FDA, for its part, will have enhanced tools to encourage ARC to promptly correct problems when they are discovered and, more importantly, to take action proactively to prevent further violations from occurring.

Because receiving blood products always carries a degree of risk, it is important that the blood industry complies with the full set of safeguards in FDA laws and regulations to minimize that risk. However, any particular breach of the safeguards does not necessarily translate into unsafe blood products, because the safeguards designed to protect the blood supply are to some extent overlapping.

"Patients who need a blood transfusion should not hesitate to get one," Dr. McClellan emphasized, "The risk of failing to get a needed blood transfusion far outweighs the risks of transfusion."

The revised consent decree between FDA and the ARC has been submitted to the court for approval and will not be enforceable until it has been approved.

[LDN, FDA, CICBC]

Power outages and food safety

[APRIL 10, 2003]  Logan County has just had its first major spring storm, and it brought a power outage, as some storms do. To prepare for a power outage, whether it comes from a spring storm or a winter storm, here are some guidelines that can be used:

• Do not open refrigerator or freezer doors. Keep them closed!!

• Normal freezer temperatures should be at 0 F, and refrigerator temperatures should be about 40 F.

• If frozen food rises above 40 F, it should be thrown out. If the food is colder than 40 F, it should still be safe to eat. Frozen food that has been thawed should be used as soon as possible. Food that has thawed and will be refrozen is safe to eat, but the quality may not be the best.

• Food that reaches above 40 F for more than two hours should be discarded.

• Examples of food that should be thrown out if the temperature rises above 40 F are meat, fish, poultry, dairy products, eggs and containers of open product where the manufacturer states "refrigerate after opening." Normally foods such as fruits and vegetables are safe to keep.

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• Refrigerators and freezers that are full may hold temperatures longer than empty ones. Bags or blocks of ice put in the refrigerator may also help lower the temperature.

• Thermometers for checking refrigerator and freezer temperatures and those used to check actual food temperatures may be purchased at most department stores or retail grocery stores.

If you're not sure whether the food is safe or not, don't take any chances. IF IN DOUBT, THROW IT OUT!!!!

If you have questions, please contact the Logan County Health Department at (217) 735-2317.

[News release provided by Kathy Waldo,
Logan County Health Department]

Health Matters

A monthly feature from  Logan County Health Department

April is Child Abuse Prevention Month

[APRIL 1, 2003]  Since 1983, when April was designed Child Abuse Prevention Month, communities across the country have used this monthlong observance to increase awareness of child abuse and its prevention. It is a time when individuals, schools, businesses, hospitals, religious organizations, and social service agencies join forces in the battle against child abuse.

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--Children count on the adults in their lives. Report suspected incidents of child abuse and neglect. In Illinois, call 1 (800) 25-ABUSE [1-800-252-7328] and in emergency situations call 911.

Prevent Child Abuse Illinois was founded in 1990 to address the issues of child abuse and neglect prevention throughout Illinois. Prevent Child Abuse Illinois accomplishes its mission through public awareness campaigns, parent education and support programs, professional training and technical assistance, and community prevention programs. For more information about Prevent Child Abuse Illinois, call (217) 522-1129 or visit www.preventchildabuseillinois.org.

Prevent Child Abuse Illinois has offices in Bloomington, Chicago, DeKalb, East St. Louis, Glen Ellyn, Harvey, Joliet, Marion, Peoria, Rock Island and Springfield. The address for the home office is 528 S. Fifth St., Suite 211, Springfield, IL 62701.

[Provided by Logan County Health Department]

Red Cross

West Nile Virus

West Nile virus links

LDN articles

• Local authorities watching WNV

Federal websites

• CDC WNV home page

State websites

• State WNV website

• Protect your home against mosquitoes
• State surveillance site
• Logan County surveillance site

Honors & Awards

• Logan County Health Department presents awards

Announcements

CICBC blood drives monthly at paramedics' building

Blood supplies across the nation are critical. In some areas, there is less than a one-day supply. Fortunately, thanks to the dedicated donors in central Illinois, these tremendous shortages have not yet touched our hospitals. However, the blood supply is a resource that must be renewed. Every three seconds someone needs a blood transfusion of some kind. To accommodate this constant usage, community members must continually help replenish the supply. Since a donor can donate whole blood only every eight weeks, Central Illinois Community Blood Center needs community members to come forward and help with this lifesaving effort.

Central Illinois Community Blood Center provides all of the blood and blood products for 12 area hospitals, including those in Lincoln, Hopedale and Springfield. No other organization provides blood in these hospitals. CICBC is a community-based blood center whose mission is to provide a safe and adequate blood supply for patients in local hospitals in a cost-effective manner.

When you donate blood through CICBC, you help to keep a safe and adequate blood supply for your community. You also help keep local medical costs under control.

Regularly scheduled blood drives are on the first Monday of each month (except Labor Day) at the Logan County Paramedic Association building, 1300 N. Postville Road. (See schedule.) Please help by donating blood.

CICBC also provides other services for the communities served, such as therapeutic phlebotomy at no charge for patients with hereditary hemochromatosis.

For more information, call Terry Bell at 753-1530.

[CICBC press release]

• May 5, noon-6 p.m., at Logan County Paramedic Association building

• May 14, hours and location to be announced

• June 2, noon-6 p.m., at Logan County Paramedic Association building

• July 7, noon-6 p.m., at Logan County Paramedic Association building

• July 15, hours and location to be announced

• Aug. 4, noon-6 p.m., at Logan County Paramedic Association building

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• Sept. 8, noon-6 p.m., at Logan County Paramedic Association building

• Sept. 24, hours and location to be announced

• Oct. 6, noon-6 p.m., at Logan County Paramedic Association building

• Nov. 3, noon-6 p.m., at Logan County Paramedic Association building

• Nov. 12, hours and location to be announced

• Dec. 1, noon-6 p.m., at Logan County Paramedic Association building

The Rural Health Partnership has announced the schedule for its mobile health unit for 2002.

For more information on the mobile health unit schedule and services, contact Dayle Eldredge at (217) 732-2161, Ext. 409.

Community resource list

This family resource list to save and use is provided by the Healthy Communities Partnership and the Healthy Families Task Force, 732-2161, Ext. 409.         

(updated 2-15-02)

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