Note: Although this is an accurate
representation of the original Letter issued to the firm, it is not an exact copy. Slight
modifications to the original Letter have been made to accommodate its conversion to the
HTML format. A scanned copy of the original Letter is
available in PDF [327 K] format on this website. |
Records do not identify the individual who reviewed the results of an NBCS query
run on [REDACTED] records on August 3, 2001 to identify donors without an
appropriate deferral code.
NBCS queries run to identify donor records without the appropriate deferral code
for Nucleic Acid Test (NAT) positive test results were not maintained, and records did not
document the identity of the individual reviewing the results.
[21 CFR 606.160(a)(1), 21 CFR 211.22, Decree Paragraph III.B.1; FDA 483
observations 106, 110, 115]
ARC failed to investigate computer software deficiencies or to implement
effective corrective action. For example,
Although a query identified approximately 1500 donor records without the
appropriate deferral code for NAT positive test results, there is no record of
investigation of the donor records, including deferral or identification of subsequent
donations that may have been unsuitable.
ARC did not investigate to determine why [REDACTED] software was released
for use by the regions without the correct assertion table.
[21 CFR 211.22, Decree Paragraph III.B.1.; FDA 483 observations 106, 113, 117]
ARC failed to maintain or follow procedures. For example,
ARC repeatedly failed to follow a work-around to resolve the problem of deferral
code omissions, when the blood type was [REDACTED] (no type determined).
ARC failed to follow its own procedures requiring the resolution within specific
time frames of donor records that have a deferral code, indicating incomplete, discrepant,
or the absence of infectious disease marker test results.
[21 CFR 606.100 (b), 21 CFR 211.100(b), Decree Paragraph III.B.1.; FDA-483
observations 111, 113, 179]
FDA investigators observed deficiencies relating to the deferral code for
syphilis during the February-April 2000 inspection of BHQ.
ARC failed to adequately investigate and promptly correct a problem with
releasing donors from a computer hold in the proper sequence during the registration data
entry process which resulted in failure to screen each donor against the regional DDR or
NDDR. For example,
Written procedures issued on June 15, 2000, as part of a corrective action, were
not followed by all regions. FDA investigators discovered that employees were not
consistently following the new procedure during inspections of two ARC regions conducted
in January-March 2001.
A June 2001 query of NBCS performed to determine whether employees had released
donor holds in the correct sequence revealed approximately 30 deviations from a third
procedure issued in April 2001 as part of the corrective action. A July 2001 query
of NBCS revealed 26 incidents of employee failure to follow the procedure.
In July 2001, ARC released a new NBCS software version to correct the donor hold
sequence problem. However, on November 14, 2001, ARC modified another new software
version and inadvertently caused the system to issue an erroneous message indicating no
potential matches in NBCS for donors being screened against the NDDR, instead of flagging
all donors who had potential matches in the NDDR. BHQ fixed the software problem in
all regions on January 2, 2002, developed a query for all regions to detect donors who
were NDDR matches, but failed to review the results of the queries until April 16, 2002.
[21 CFR 211.22, 21 CFR 606.160(e), Decree Paragraph III.B.1.; FDA 483 observations
61, 62, 63, 64, 65, 66, 67, 68]
FDA investigators noted similar deficiencies pertaining to the donor hold
process during the February-April 2000 inspection of BHQ.
ARC failed to implement adequate corrective action to ensure that correct donors
are selected from a computer screen pick pan during the donor registration process.
Selection of the wrong donor results in association of a whole blood number with the wrong
donor record in NBCS, inability to trace blood products in the event of a recall or
lookback investigation, and inability to prevent release of blood products from a donor
who has been previously determined to be unsuitable. For example,
Effective June 2000, ARC’s implemented corrective action to prevent
incorrect donor selection by data entry personnel. BHQ ended the monthly monitoring
requirement in April 2002, although regional reports showed continuing deviations.
ARC failed to perform a retrospective review of donor records in NBCS to
determine whether all donors were properly selected from the pick pan during the
registration process.
[21 CFR 211.22, 21 CFR 606.160(b)(1)(vii), 21 CFR 606.160(c), 21 CFR
606.165(a), Decree Paragraphs III.B.1., III.B.12., III.B.13.e.; FDA 483
observations 72, 73]
FDA investigators observed similar deficiencies relating to the selection of
the incorrect donor from the computer screen pick pan during donor registration, in the
February-April 2000 inspection of BHQ.
ARC failed to resolve all duplicate donor records, which can result in donations
being associated with the wrong donor record and potential release of blood products
collected from unsuitable donors. ARC also failed to report unresolved duplicate
donor records to FDA. For example,
ARC performed a retrospective review of records and found that two regions had
reported to FDA unresolved duplicate donor records in November 2000 and April 2001.
BHQ failed to determine the reason for the deviations and to identify a preventive action.
In February 2002, ARC reported to FDA that one region had unresolved duplicate
donor records. BHQ’s investigation failed to determine whether any other
regions had unresolved duplicate donor records.
[21 CFR 211.22, 21 CFR 606.160(e), Consent Decree Paragraphs III.B.8., III.B.9;
FDA 483 observation 74]
FDA investigators observed similar deficiencies involving unresolved
duplicate donor records during the February-April 2000 inspection of BHQ.
MISSING/INCORRECT INFORMATION ON BLOOD DONATION RECORDS
ARC failed to implement adequate corrective action to ensure that procedures for
determining donor suitability during the donor screening process are followed. For
example,
An audit conducted by ARC in November 2001 found 29 BDRs in one region that had
missing or incomplete answers to health history questions. Forty-four blood
components were recalled as a result of the deviations. The audit found that
these 29 deviations were not discovered during ARC’s required review process.
Biological Product Deviations reported to FDA for the period December 30, 2001
through June 1, 2002, show 35 instances of released blood products collected from donors
who had not completed their BDRs. The errors were not discovered during ARC’s
required review process.
[21 CFR 211.22, 21 CFR 640.3(a), 21 CFR 211.100(b), Decree Paragraphs III.B.1.,
X.; FDA 483 observations 75, 76, 77]
FDA notified ARC of similar deficiencies in the October 19, 2001 VI.A.
letter issued following the inspection of ARC’s Salt Lake City facility, and in the
July 31, 2002 VI.A. letter issued following the inspection of ARC’s Greater
Chesapeake and Potomac Region.
RED BLOOD CELL MANUFACTURING
ARC failed to ensure that leukoreduced red blood cells (RBC) were manufactured
in accordance with its procedures and with blood bag manufacturer instructions, and failed
to implement adequate corrective action after detecting RBC manufacturing
deviations. For example,
ARC recalled over 5,000 RBC components after discovering in July 2001 that,
since April 1998, regions were not manufacturing RBCs within eight hours of collection,
when the components had been held at room temperature.
BHQ’s corrective action plan required only a 90% reduction of deviations in
RBC manufacturing. The corrective action plan also required an effectiveness check
by June 2002, but BHQ failed to perform that check. Additionally, BHQ failed to
determine whether manufacturing employees received adequate training in the procedures and
blood bag manufacturer instructions applicable to RBC manufacturing.
BHQ identified an NBCS software modification to prevent such RBC manufacturing
deviations in July 2001 and an NBCS software modification to detect RBCs created outside
of time limits in January 2002. Neither modification has been included in an NBCS
release.
[21 CFR 211.22, 21 CFR 211.100(b), 21 CFR 606.65(e), Decree Paragraph III.B.1.;
FDA 483 observations 82, 85, 86, 87, 88]
RELEASE OF INCOMPLETE TEST RESULTS
ARC failed to thoroughly investigate and to adequately correct deviations
related to electronic transfer of incomplete viral marker test results. For example,
blood samples that had initial reactive results for hepatitis B surface antigen (HBsAg)
were not retested in duplicate, as required. Although the tests were incomplete,
ARC’s software allowed negative test results for those samples to be transferred to
customers for whom ARC performs viral marker testing. For example,
BHQ did not perform a review of all electronically transferred test results, did
not document a rationale for failing to do so, and did not determine whether any
unsuitable blood products were released as a result.
BHQ’s corrective action included issuing written instructions for review of
test results, when multiple National Testing Laboratories (hereafter, NTL) have
responsibility for testing. However, those instructions were inadequate, in that
critical parameters were omitted, such as specifying the NTL responsible for reviewing and
releasing test results when more than one NTL performs testing.
Records of BHQ’s investigation do not address the failure to follow
ARC’s change control procedure and the adequacy of that procedure.
[21 CFR 211.22, Decree Paragraph III.B.1.; FDA 483 observations 178, 179, 180]
ARC failed to ensure that personnel responsible for the collection, processing,
compatibility testing, storage, or distribution of blood or blood components have adequate
training to assure competent performance of their assigned functions. For example,
ARC provided no training for individuals responsible for receiving,
prioritizing, and evaluating hotline reports. Additionally, ARC provided no training
for individuals responsible for directing hotline report investigations, evaluating those
investigations, and evaluating the final resolution of hotline reports.
ARC has no formal training program to ensure that employees responsible for
performing donor file checks have a thorough understanding of the procedures.
BHQ did not require employee training in a new donor hold procedure implemented
as a corrective action for donor hold deviations. BHQ’s investigation of the
failure by personnel to follow that procedure did not determine whether employee training
was adequate.
ARC failed to determine whether employees received adequate training in the
procedures for manufacture of red blood cells and the blood bag manufacturer’s
instructions applicable to red blood cell manufacture.
[21 CFR 606.20(b), Decree Paragraph III.C.; FDA 483 observation 49, 62, 64, 65,
87, 92]
During the inspection of BHQ, FDA investigators had difficulty obtaining records.
For example, ARC management stated that FDA’s request for access to ARC’s
regional deviations relating to the donor file check process should not be covered during
the inspection of BHQ. Additionally, FDA investigators requested access to hotline
records in August 2002, but all records were not provided until November 2002. FDA
is very concerned about the delayed access to these records, and therefore, reminds ARC
that FDA has authority under 21 U.S.C. 374 to inspect ARC blood establishment
facilities. Such inspections shall, according to the law, extend to all things
therein, including records, files, and papers. Additionally, paragraph IX of the
Decree states that ARC shall permit duly authorized FDA representatives to make
inspections to evaluate ARC’s compliance with the Decree as FDA deems necessary.
This list is not intended to be an all-inclusive list of deficiencies at your
establishment.
Although this letter focuses on observations made during the April—December 2002
inspection of BHQ, FDA expects that all corrective actions taken in response to this
letter will also be implemented at other ARC regions and facilities, as necessary.
FDA expects
ARC to promptly take steps necessary to fully comply with the law, ARC’s standard
operating procedures, and the Decree.
Paragraph VI.B. of the Decree requires that ARC respond to this notification within ten
business days. As with other correspondence submitted pursuant to the Decree, the
response should be sent to Lee Bowers, District Director, Baltimore District Office, 6000
Metro Drive, Suite 101, Baltimore, Maryland 21215, with a copy to Jesse Goodman, M.D.,
Director, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200 N,
Rockville, Maryland 20852.
Sincerely,
John M. Taylor, III
Associate Commissioner for Regulatory Affairs
cc:
Ramesh Thadani
Executive Vice President & CEO
Biomedical Services
American National Red Cross
1616 Fort Myer Drive
Arlington, Virginia 22209
Mary Elcano
General Counsel
American National Red Cross
430 17th Street, NW
Washington, D.C. 20006
David T. McLaughlin
Chairman, Board of Governors
American National Red Cross
430 17th Street, NW
Washington, D.C. 20006
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