Honorable Edward M. Kennedy
Ranking Minority Member
Health, Education, Labor and Pension Committee
Dear Senator Kennedy,
Last December I wrote to you concerning the health-threatening problems of the American Red Cross (ARC) and the Food and Drug Administration’s (FDA) long-standing efforts to force the agency into compliance with federal laws and regulations governing the collection, processing and distribution of blood and blood components. I asked you to hold hearings concerning this serious problem and you agreed, but this was not possible because neither the FDA nor the Red Cross was willing to appear because of pending litigation in which the FDA had asked that the Red Cross be held in contempt of court for flagrant violations of the 1993 consent decree. I am aware that your office has been involved in ongoing surveillance over this matter and am therefore forwarding you some new evidence concerning this serious problem.
A recently concluded FDA inspection of ARC National Headquarters in Arlington Virginia, begun on April 22, 2002 and intermittently continued, but not finished until December 20th of this year, found some of the worst violations of FDA law and regulations and most reckless disregard of the terms of the 1993 Consent Decree I have ever seen, a total of 213 violations – considerably more than the 63 violations found in the last such inspection, in April 2000, of ARC headquarters.
The 134 cases of suspected post transfusion hepatitis, discovered in the recently concluded FDA inspection, which were not investigated by the ARC because of essentially illegal ARC policies (see page three of this letter), emphasize the dangerously cavalier attitude of previous ARC statements of assurance about the safety of the blood supply. A declaration filed by FDA official Dr. Jay Epstein in December of last year, as part of FDA’s seeking a contempt of court citation against the ARC, was critical of the ARC’s assertion that the blood supply is safe since there has been no documentation of transfusion associated infections from unsuitable ARC blood products. Dr. Epstein warned that this is “a notoriously dangerous assumption to make.”
Investigation of Suspected Post Transfusion Hepatitis (fatality) (violations 6-9, pages 3-5):
Failing to investigate cases of post transfusion hepatitis in which “another more likely cause [other than infection from the transfused product] is not apparent” is certainly one way, like an ostrich with its head in the sand, the ARC will be unlikely to document the source of the cases of post transfusion hepatitis or other clinically significant infections arising after transfusions of blood or blood products and thereby can continue to claim that the blood supply is safe.
As can be seen on the following page (violation 6), FDA found that ARC “[p]rocedures do not require a thorough investigation of the occurrence of a clinically significant infection or infectious disease that occurs in a recipient of a blood product that could have resulted from transfusion and for which another, more likely, cause is not apparent.” FDA found these procedures to be a violation of Consent Decree, III.B.14. The current ARC policy only requires such an investigation if it was already known that the donor was on a deferred (from donating blood) list or had been known to have an abnormal hepatitis test result. The case discussed below (violation 7) illustrates the Catch-22 nature of this dangerously flawed ARC policy.
In violation 7, also shown on the next page, the Red Cross failed to do an adequate investigation following the death, from hepatitis B, of a patient who had received, three months previously, two units of red blood cells manufactured by the ARC. Although there was no other explanation for the fatal hepatitis B infection, the ARC failed to recontact the donors for the purpose of retesting (for hepatitis B) or to verify of the health history (to recheck for hepatitis risk factors) because the donors of that blood were not listed in the Donor Deferral Registry and had not had any abnormal hepatitis blood tests when they donated.
Violation 8 states that “134 SPTHEP [suspected post transfusion hepatitis] cases across all 36 [Red Cross] regions for the period
Violation 9 spells out the details of the illegal ARC policy whereby “BHQ [ARC’s Biomedical Headquarters] only allows the regions to investigate a case that exceeds the ARC’s pre-established limit of ten units for litigation reasons or when contacted by a local health department.” In other words, if the person contracting post transfusion hepatitis had received blood or blood products derived from more than 10 donors, ARC policy, in violation of the Consent Decree, would only allow an investigation if the Red Cross regional office requested a variance from the ARC to this dangerous policy. The FDA cites an instance, involving the Northern Ohio Region, in which such an investigation of a case of post transfusion hepatitis following transfusions involving 36 different donors, found an implicated blood donor “who was involved in a previous SPTHEP case” and “would NOT have been located and properly deferred [permanently from giving blood] had the region not requested a variance [from ARC] to investigate this case.”
Excerpts from 45 page FDA Form 483, dated
12/20/02, following 4/22/02 to 12/20/02 inspection of American National Red Cross/Biomedical Services in Arlington, VA.
In addition to the series of violations concerning the ARC’s failure to obey the law, regulations and the terms of the 1993 consent decree with respect to investigations of cases of suspected post transfusion hepatitis, there were many other violations delineated in the 45-page FDA inspection report. A summary of just a few of the categories of violations follows, with a reference to the number of the violation(s) and the location in the 45-page inspection report.
Inadequate investigation of employee allegations of significant recordkeeping irregularities (violations 2-4, pages 1 and 2):
“the quality assurance officer in the NTL [national testing laboratory] stated there was a ‘culture to hide problems;’”
another employee “reported fearing retaliation if she was seen reporting a problem to the supervisor;”
staff interviewed “verified they found documents which were changed and their initials had been forged in the changed documents;”
An employee caller to an ARC hotline stated “acting supervisor instructs employees to falsify documents in order to hide mistakes.”
Lost Product/Transfusable (violation 10, page 5):
“Since the previous [FDA] inspection [of the ARC] in April, 2000 the disposition of approximately 1062 blood products can not be determined. This includes the failure of the ARC to know the disposition of the following six unsuitable blood products between
The table describing these six cases mentioned in violation 10 is reproduced on the following page. It can be seen that for three of these lost, transfusable items, two were blood products (whole blood and plasma) that had been found positive for hepatitis C, another was positive for HIV, another for HTLV1 (human T-cell lymphoma virus 1) and the remaining two had either no test results or missing test results. To be unaware of whether these clearly unsuitable products have, in fact, been transfused because the ARC does not know about their disposition is further evidence of serious problems with the safety of the blood supply.
From page five of 45 page FDA Form 483, dated
Release of Unsuitable Products (violation 21, page 8):
According to the FDA inspectors, “since January 2001 there have been 30 recall events and a total of 1850 components recalled due to collection QC [quality control] problems.” In other words, 1850 unsuitable blood products that had been shipped out for potential use had to be recalled because the Red Cross region “failed to quarantine unsuitable products.”
Because of repeated instances of dangerous blood handling practices by a number of U.S. ARC regional blood banks, and a failure by the ARC to abide by a voluntary 1988 agreement with the FDA to solve these problems, the 1993 consent decree was entered by U.S. Federal District Judge Stanley Sporkin. This decree required the ARC to establish management control over blood service operations and to establish a quality control program.
Examples of problems which precipitated this consent decree included inspections following the 1988 voluntary agreement which found such serious violations of FDA laws and regulations that the FDA issued three Notices of Intent to Revoke for various ARC establishment licenses and actually revoked one license (the
It is clear from the recently completed inspection of ARC National Headquarters that these serious problems continue to persist, jeopardizing the health of people depending on the blood supply to be safe. Any doubt as to why the FDA asked a Federal Court to hold the ARC in contempt of court for their continued flagrant violations of the 1993 consent decree is clearly erased by the 213 violations found during the recent FDA inspection, including many very serious ones as summarized above. Too many of them reflect a continuation, in some ways a worsening, of the negligence documented during the last ARC National Headquarters inspection more than 2 ½ years ago in April 2000.
FDA found, during that inspection, “a deficient quarantine system that does not prevent release of unsuitable products; improper release by ARC of cytomegalovirus (CMV)-positive blood products; donors being associated with incorrect histories; inadequate ARC oversight of system problems; failure to follow manufacturer’s test kit instructions (for human immunodeficiency virus (HIV) p24 antigen neutralization), resulting in the failure to perform look back investigations; lack of timeliness in addressing problems; inadequate assessment of problems.”
I hope that your investigation of this matter will provide support to the FDA’s efforts to make our blood supply, approximately 50 percent of which is handled by the ARC, much safer than it has been. Please call if you have any questions and, as usual, I would be glad to meet with your and your staff.
Sidney M. Wolfe, M.D.
Public Citizen’s Health Research Group
 Epstein, Jay. Declaration of Jay S. Epstein, MD,
 Notice of Intent to Revoke means that a licensed blood manufacturing establishment has had continuing violations which are so significant that the FDA intends to withdraw authorization to ship blood products in interstate commerce.
 November 28th Declaration of Robert Bowers, FDA Baltimore District Director