DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
July 27, 2006
ADVERSE DETERMINATION LETTER
BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. John F. McGuire
President and CEO &
Executive Vice President
Biomedical Services
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
RE: United States v. American National
Red Cross, Civil Action No. 93-0949 (JGP)
Dear Mr. McGuire:
The United States Food and Drug Administration (FDA) inspected
the manufacturing and distribution facility of the Greater
Chesapeake and Potomac Region (GCPR) of the American National
Red Cross (ARC), located at 4700 Mount Hope Drive, Baltimore,
Maryland 21215, on a number of days between September 13,
2005 and January 30, 2006. During the inspection, FDA investigators
observed many violations of the law, FDA regulations, and
the Amended Consent Decree of Permanent Injunction entered
on April 15, 2003 (Decree). In this letter we discuss
only the observation that GCPR failed to thoroughly investigate
and correct a significant training record irregularity. FDA
is still reviewing ARC’s response to the other issues
listed in the Form FDA 483 Inspectional Observations (FDA
483) issued at the conclusion of the inspection.
FDA investigators notified GCPR of the violation verbally
on January 19, 2006 and in writing on January 30, 2006,
in the Form FDA 483 (copy attached). FDA has
reviewed ARC’s March 30, 2006 response regarding
the training record irregularity and finds it inadequate. Pursuant
to Paragraph VIII of the Decree, FDA is now notifying ARC
of its determination that ARC has violated the law, regulations,
and the Decree.
On August 9, 2005, a GCPR [REDACTED]
and her supervisor both signed the employee’s training
record indicating that she had been trained and was competent
to perform twelve separate blood collection tasks, even
though the employee had been trained to perform only seven
of those tasks.1 According
to GCPR’s problem report, the employee only performed
one of the five tasks for which she had not been trained,
Whole Blood Collection Set Preparation, before the problem
was discovered two months later by GCPR, on October 11,
2005.2 The
report does not state how many times the employee performed
the task, which, if not performed correctly, could have
resulted in whole blood number mix-ups. Whole blood
number mix-ups pose a significant potential health risk, e.g.,
communicable disease test results could be associated with
the wrong donor, and/or a unit of blood could fail to be
correctly associated with its donor in the donor deferral
database. The first situation places both recipients
and donors at risk: an unsuitable donor, such as
an HIV-positive donor, would not be prevented from making
subsequent donations because test results have been associated
with the wrong donor record, which would also result in
the donor not being contacted about the HIV-positive test
results. The second situation places recipients at
risk because a unit of blood from an unsuitable donor may
be distributed (even when a donor’s deferral status
is later detected).
On October 11, 2005, GCPR became aware of the problem with
the training record, and a GCPR Education Coordinator initiated
an investigation and notified the Regional Quality Director. GCPR
classified the incident as a problem requiring a [REDACTED]
investigation (moderate risk). ARC’s [REDACTED]
requires [REDACTED] investigations to
[REDACTED] [REDACTED]
requires the problem manager to determine root causes of
the problem.
On November 1, 2005, a Problem Manager, a Quality Assurance
representative, the Education Coordinator, and a blood
collection supervisor met to determine and document the
root cause of the problem and develop a corrective action
and an effectiveness check. The group concluded that
the root causes were that the employee had [REDACTED]
and the Education Coordinator failed to compare the employee’s
previous training transcript with the training requirements
for GCPR whole blood collections staff 3,
and that the employee signed the training record without
realizing that she had not been trained for certain tasks. The
proposed corrective action was to fully re-train all employees
who [REDACTED], and the proposed effectiveness
check was to ensure that the re-training occurred.
On January 3, 2006, GCPR Quality Assurance approved the
results of the effectiveness check and closed the problem,
ending its investigation. However, the problem file
contains no documentation that GCPR conducted a thorough
investigation to discover why the employee and supervisor
both signed the erroneous training record, even though
the first page of the record explains the scope of the
training reflected by a signature.4 As
a result of the incomplete investigation, GCPR failed to
determine all root causes of the problem, in violation
of ARC’s SOPs
(standard operating procedures) and [REDACTED]. As
mentioned above, FDA notified GCPR of this violation on
January 19 and 30, 2006, and ARC provided its response
to FDA on March 30, 2006.
This record discrepancy is significant because it is not
an isolated incident, reflects a troubling and recurrent
pattern, and presents serious potential health risks. FDA
has previously notified ARC of its failure to adequately
investigate recordkeeping irregularities, or allegations
of such irregularities, at other facilities.5 Moreover,
the erroneous record indicates a problem with the integrity
of GCPR’s records, and the incomplete investigation
does not allow for adequate corrective measures, including
measures to address systemic records integrity problems. In
fact, the manner in which the incident was coded in ARC’s
automated problem management system — as a training
problem, with no mention of the erroneous information in
the training record — would prevent the records integrity
issue from gaining the attention of ARC senior management
and would have prevented this incident from being reviewed
as part of ARC’s historical problem with records
management.
ARC’s March 30, 2006 response states that GCPR took
several additional actions to correct and prevent recurrence
of the training record irregularity, including management
review, with the staff involved in the incident, of the
training process and the significance of signatures on
training records, and management review of certain SOPs
with supervisory staff and collection education coordinators. However,
ARC submitted no documentation to support the additional
corrective actions.6 Without
documentation of the additional corrective actions, FDA
cannot evaluate fully ARC’s response. Furthermore,
ARC’s response does not address GCPR’s failure
to conduct a thorough investigation of the problem to determine
why the employee and her supervisor signed the erroneous
record.
The definition of “problem” in the Decree
includes “any deviation from the law, ARC SOPs, or
this Order . . . . ” Paragraph IV.B.1.a.ii of
the Decree requires each region “commensurate with
the nature of the problem, [to] promptly, thoroughly and
adequately investigate, correct, and take steps to prevent
the recurrence of each problem . . . .” Here,
GCPR failed to adequately investigate, correct, and take
steps to prevent the recurrence of this document integrity
and training problem, in violation of the Decree. Additionally, 21 C.F.R. § 211.22(d) requires that “the
responsibility and procedures applicable to the quality
control unit shall be in writing . . . [and] shall be followed.” Here,
GCPR failed to follow its own written procedures, [REDACTED],
in violation of 21 C.F.R. § 211.22(d).
Paragraph VIII of the Decree provides that “[i]n
the event that FDA determines, based upon inspection .
. . review of ARC records, or other information that
comes to FDA’s attention . . . that ARC is
not following any SOP that may affect donor safety or the
purity or labeling of blood or any blood component, . .
. has violated the law; has failed to fully comply
with any . . . term or provision of this Order .
. . then FDA may order ARC to come into compliance
with the law, ARC SOPs, or this Order, assess penalties,
and/or to take any step that FDA deems necessary to bring
ARC into compliance with the law, ARC SOPs, or this Order.” For
the reasons stated above, FDA has determined that ARC did
not comply with the law, ARC SOPs, and the Decree.
Therefore, FDA orders ARC to ensure that all ARC quality
assurance staff are informed that they must promptly and thoroughly investigate,
correct, and prevent all recordkeeping irregularities,
including irregularities that involve signing records that
do not accurately reflect tasks performed or employee training
and competency, that quality assurance staff promptly and
adequately document such thorough investigations and properly
identify recordkeeping irregularities as such, and that
quality assurance staff promptly bring any records integrity
problem to the attention of ARC senior management.
In addition, pursuant to Paragraph IX of the Decree, FDA
is fining ARC $2,000 for each day from August 9, 2005 (the
day the violation occurred) through October 11, 2005 (when
ARC discovered the violation); $3,000 for each day from
October 12, 2005 through January 19, 2006 (when FDA first
notified ARC about its inadequate investigation); $4,000
for each day from January 20 through March 30, 2006 (when
ARC submitted its inadequate response to FDA); and $1,000
for each day from March 31 through April 13 (the first
10 working days during which FDA reviewed ARC’s response). The
subtotal for the fine, before including a fine amount to
be determined for the number of days for submission of
ARC’s compliance plan, is $718,000. If the
compliance plan is not adequate, additional penalties may
be assessed.
As provided in the Decree, if ARC agrees with this adverse
determination, ARC shall, within twenty (20) days of receipt
of this letter, notify FDA of its intent to come into compliance
with the Decree and submit a plan to do so, and shall pay
the fine no later than thirty (30) days thereafter. If
ARC disagrees with FDA’s adverse determination, it
shall respond in writing within twenty (20) days of receipt
of this letter, explaining its reason for disagreeing with
FDA’s determination. Your response must be submitted
to me at the Food and Drug Administration, Baltimore District
Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland
21215, with a copy to Jesse Goodman, M.D., M.P.H., Director,
Center for Biologics Evaluation and Research, 1401 Rockville
Pike, Suite 200 N, Rockville, Maryland 20852.
Sincerely yours,
[Handwritten Signature]
Evelyn Bonnin
Director, Baltimore District
ATTACHMENT
cc:
C. William Cherry
Senior Vice President for Quality
and Regulatory Affairs
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006 Mary Elcano
General Counsel
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 2006
Bonnie McElveen-Hunter
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 2006
[1]
The Decree requires ARC employee training files to include
a “list that
identifies each procedure for which the employee is responsible” and
a statement “signed by the employee and that employee’s
supervisor attesting to the fact that the employee . . .
has received, successfully completed, and understands the
training specified in the [Decree], and that as a result
of the foregoing, the employee is qualified, competent, and
ready to perform each such procedure.” Paragraph
IV.C.5.f.
[2] The Decree
further requires ARC employees to be trained and competent
in procedures before performing them. Paragraph IV.C.6.
[3] As ARC’s
March 30, 2006 response clarified, the Education Coordinator’s
failure to compare the employee’s training transcript
from [REDACTED] with training requirements
for GCPR whole blood collection staff resulted in the failure
to inform the employee’s supervisor about the need
for training.
[4] The first page
of the training record states: [REDACTED]
[5] FDA notified
ARC of its failure to follow its own SOPs and failure to
adequately investigate recordkeeping irregularities in (1)
an FDA 483 issued in December 2002 to ARC’s Biomedical
Headquarters; (2) in an April 14, 2003 letter to ARC issued
under Paragraph VI.A. of the 1993 Consent Decree of Permanent
Injunction; and (3) in a May 28, 2005 Adverse Determination
letter based on violations observed at ARC’s Southern
California Region’s manufacturing and distribution
facility. In
fact, precisely because similar recordkeeping irregularities
occurred under the 1993 Consent Decree, the United States
insisted upon having recordkeeping requirements, including
accuracy, incorporated in Paragraph IV.B.9.b of the Amended
Decree.
[6] Paragraph IV.B.1.a.ii
of the Decree requires ARC to document corrective actions: “Each
region and laboratory shall thoroughly and contemporaneously
document each step it takes to investigate, correct, and
prevent recurrence of each problem . . . .” |