FDA Fines American Red Cross for Violating Blood Safety Rules

  • By: Staff Editor
  • Date: February 10, 2012
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The American Red Cross, which supplies 40 – 45% of donated blood in the U.S., was recently fined by the FDA for substandard and unsafe practices on blood management and for failing to rectify these violations.

A January 13, 2012 Bloomberg report said that “The American Red Cross violated the blood-safety rules thereby increasing the risk that ill-fitted blood may be used in blood transfusions”. This was based on an audit conducted at 16 regional centres of Red Cross between April to October 2010 which resulted in a penalty of $ 9.59 million being imposed by U.S Food and Drug Administration. This is the second time a multi-million dollar fine was imposed on American Red Cross.
Violation of Blood Safety Rules by the American Red Cross
  • Adequate training on blood-safety was not imparted to the staff. Staff handling donated blood was incompetent in disposing their assigned duty and had inadequate experience and training.
  • Lack of an accurate and complete list of prospective donors who were not eligible for donating blood.
  • Most of the regional operating centres of the Red Cross were seriously understaffed.
  • Employees were instructed to omit the intervening safety steps and changed the data accordingly in the records.
  • Further release of blood which failed the standards of blood testing and in the process, greater than 1.000 units of blood were unaccounted for.
  • Lack of screening for people who were unfit for blood donation.
  • Inadequate activities relating to Quality assurance and lack of management control.
  • Documentation of mandatory testing steps was not done on a regular basis.
  • Non-compliance to Standard Operating Procedures (SOP’s).
  • Substandard performance in performing functions related to blood donation.
However, the FDA found no evidence that these violations have caused any dire health concerns in people but such violations created conditions that could give rise potential safety consequences.
What are the rules and regulations regarding Blood Safety?
The FDA in collaboration with CBER (Centre for Biologics Evaluation and Research) and ORA (Office of Regulatory Affairs) is responsible for the safety of the blood supply used for transfusions. The FDA issues and enforces rules and regulations regarding blood-safety, specifically:
  • Safeguarding the health of both the donor and the recipient,
  • Preserving the safety, supply and integrity of blood and its products,
  • Preventing the transmission of infectious diseases
The FDA oversees the following:
  • Approval of all licences regarding blood products
  • Approval of all devices which are used for both infectious disease testing and blood collection
  • Enforcement and improvement of quality standards
  • Inspection of problem facilities at frequent intervals
  • Thorough inspection of all facilities every two years
  • Initiating legal action in case of any issues
Organizations should ensure:
  • Proper handling and supply of blood and blood products
  • Correct informative material to be provided to donors so that they can assess their risk
  • Effective quality control procedures for blood-safety testing
  • Informed consent and sensitive approach in communicating with the donor
  • Regular monitoring for any adverse events or other errors
Five layers of safety exist in the form of:
  1. Donor Screening: A detailed questionnaire about the donor’s medical history and other factors which may affect safety of blood.
  2. Donor deferral lists. This list should have updated details of deferred members.
  3. Blood Testing: Every unit of blood must be tested for the presence of infectious disease agents.
  4. Quarantine. Blood collected must be quarantined and tested. It should be free from any disease causing agents.
  5. Other Problems and deficiencies: Problems regardingmanufacturing, other errors must be thoroughly investigated. In case of any deviations, the concerned regulatory authority should be notified.
According to 2003 - Law on Blood Safety, penalties will be imposed on organizations which fail to follow U.S standards for preventing contaminated blood-transfusions.
FDA’s claims regarding these violations:
  • Inadequate documentation raises the liability of contaminated blood being used for donation.
  • Corrective action for violations was either incomplete or ineffective.
  • These violations can harm donors and may allow improper blood in the country’s supply.
  • The possibility of transfusion of contaminated blood cannot be ruled out and this could have compromised the safety of country’s blood supply through release into hospitals.
  • The agency said that it was unsuccessful in improving the quality aspects and reported as many as 200 violations of federal blood safety rules.
American Red Cross Response
According to the statement released in response to these violations, the American Red Cross claims that it is fully charged to meet the standards set by the agency and has in fact worked on previous violations by taking necessary corrective measures and will continue to stay in compliance with all regulations. They further confirmed that no adverse reactions or other health issues have occurred due to the discrepancies and their redundant systems has prevented such things.
The Red Cross acknowledged that it needs to work harder to strengthen its role and assured to correct the violations and improve the safety aspects. It has also confirmed that it has increased its staff so that process can be reviewed and updated and that they have upgraded their computer applications and are maintaining electronic records in order to focus on quality aspects and reduce the incidence of discrepancies.


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