UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
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UNITED STATES OF AMERICA,
PLAINTIFF,
v.
AMERICAN NATIONAL RED CROSS
a corporation,
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Civil No. 93-0949
(JGP)
AMENDED CONSENT
DECREE OF
PERMANENT INJUNCTION
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DEFENDANT.
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Plaintiff, United States of America, having filed a Complaint
for permanent injunction on the 7th day of May,
1993, this Court having entered a Consent Decree of permanent
injunction on the 12th day of May, 1993, the United
States having thereafter on December 13, 2001 filed a motion
seeking to hold the American National Red Cross in contempt
thereof, and the defendant, American National Red Cross, a
corporation created by Act of Congress, having
appeared and having consented to the entry of this amended
consent decree (hereafter, "Order") in order to further its
commitment to provide safe blood and enable it to focus on
blood safety rather than litigation, and without admitting
or denying the allegations in said motion, and the United States
of America having consented to this Order, and having moved
this Court therefor,
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED, that:
I. This Court has jurisdiction over the subject
matter herein, and has personal jurisdiction over all parties
to this action.
II. The Complaint for injunction states a
claim for relief under the Federal Food, Drug and Cosmetic
Act (FDC Act), 21 U.S.C. section 301 et seq., and
the Public Health Service Act (the PHS Act), 42 U.S.C. section
201 et seq.
III. DEFINITIONS:
- The definitions in this paragraph apply throughout the
Order. Defined terms are italicized when used in the Order.
- Defined Terms:
- ABO/Rh testing: laboratory testing for blood
group and Rh type (e.g., A negative) that
satisfies the requirements of 21 C.F.R. §§ 640.5(b)
and 640.5(c);
- adverse reaction: any undesirable event
associated with the collection of blood, or
any undesirable recipient reaction associated with
the transfusion of any blood or blood components, whether
or not considered product related;
- Analysis and Investigation Group: specific
persons within the Quality Assurance unit at ARC
National Headquarters (to be identified by ARC in
writing by position in its SOP) responsible
for initiating and completing a thorough analysis and
investigation of each Summary Problem Report submitted
by each region and laboratory to
discover trends and system problems,
and for issuing an Analysis and Investigation Report to ARC
senior management;
- Analysis and Investigation Reports: reports
written by the Analysis and Investigation Group that
identify and analyze trends and system
problems;
- ARC: American National Red Cross, including,
but not limited to, ARC National Headquarters,
ARC Biomedical Headquarters, ARC's National
Confirmatory Testing Laboratory, each ARC National
Testing Laboratory, ARC's National Testing
and Reference Laboratory, and each region;
- ARC Biomedical Headquarters: The ARC components
that oversee the collection, manufacturing, processing,
packing, and distribution of blood and blood
components in all ARC facilities;
- RC Biomedical Services Committee: A committee
of ARC’s Board of Governors consisting of
the Chairman of ARC 's Board of Governors
and not fewer than 10 nor more than 14 members. A majority
of the members must be on the ARC Board of
Governors;
- ARC Biomedical Services senior management: the
Executive Vice President and Chief Executive Officer,
Biomedical Services; the Senior Vice President and
Chief Operating Officer, Biomedical Services; the Vice
President and Chief Operating Officer, Plasma Services,
Biomedical Services; the Senior Vice President, Quality
and Regulatory Affairs, Biomedical Services (also referred
to herein as Director of Quality Assurance); the Director
of Training, Biomedical Services (also referred to
herein as the Director of Training); the Vice President
and Chief Scientific Officer, Biomedical Services;
and any persons acting in these capacities or performing
their duties;
- ARC National Headquarters: The ARC component
that oversees ARC Biomedical Headquarters and
all other ARC national non-blood health and
safety services programs;
- ARC senior management: the President and
Chief Executive Officer, ARC; the Executive
Vice President and Chief Executive Officer, Biomedical
Services; the Senior Vice President and Chief Operating
Officer, Biomedical Services; the Vice President and
Chief Operating Officer, Plasma Services; the Senior
Vice President, Quality and Regulatory Affairs, Biomedical
Services; the Chief Information Officer; General
Counsel; and any persons acting in these capacities
or performing their duties;
- audit SOPs: standard operating procedures
governing ARC internal audits;
- biological product deviation: a deviation
from CGMP, applicable regulations, applicable
standards, or established specifications that may affect
the safety, purity, or potency of distributed blood or blood
components, or an unexpected or unforeseeable
event that may affect the safety, purity, or potency
of distributed blood or blood components;
- blood: whole blood collected from a single
donor and processed either for transfusion or further
manufacture, as defined in 21 C.F.R. § 606.3(a);
- blood component: part of a single donor's blood separated
by physical or mechanical means, as defined in 21 C.F.R. § 606.3(c),
and for purposes of this Order, any products derived
therefrom;
- blood establishment computer software (“computer
software”): all software and software accessories
(such as software interfaces), intended for use in
the manufacture of blood or blood components or
for the maintenance of data that personnel use in
making decisions regarding the suitability of donors,
the release of blood or blood components for
transfusion or further manufacture, and for the maintenance
of records of product disposition;
- BSDs: ARC Blood Services Directives;
- BSLs: ARC Blood Services Letters;
- business days: Monday through Friday, excluding
federal holidays;
- CGMP: current good manufacturing practice;
- Clarify reports: reports to ARC Biomedical
Headquarters from regions and laboratories used
by ARC to record issues related to approved
biomedical services, processes, and systems;
- CMV: cytomegalovirus;
- computer software assessment: a review of computer
software requirements, design specifications,
hazard analyses, traceability, testing, error reports,
and outstanding computer software defects to
ensure the device meets user needs and intended use
and follows required design controls to ensure the
integrity of the device;
- computer software defect: a fault or problem
that exists in the computer software, whether
or not design related, which, if not corrected, could
cause the computer software to fail or produce
incorrect results;
- confirmatory testing: a more specific test
performed on a sample of blood that tested
repeatedly reactive by a screening test for a viral
marker, to ensure that the screening test results were
accurate;
- corrective action effectiveness criteria: all
factors that ARC has identified for use in
assessing whether an implemented corrective action
has adequately corrected the problem, trend, system
(systemic) problem, or deficiency that it was
intended to correct, will prevent recurrence of that problem,
trend, system (systemic) problem, or deficiency,
and will not adversely affect any other system or process;
- Corrective Action Monitoring Reports: ARC reports
written by Corrective Action Monitors that
clearly state whether the Corrective Action Plan is
being properly and timely implemented, whether each
of the corrective action effectiveness criteria in
the Corrective Action Plan is being met, and
whether the plan is effective to prevent the recurrence
of the problems, and that describe in detail
any impediments or difficulties encountered that may
prevent effective and timely implementation of the Corrective
Action Plan and any changes necessitated thereby;
- Corrective Action Monitors: specific persons
at ARC Biomedical Headquarters, to be identified
by ARC in writing by position in its SOP,
responsible for actively, carefully, and at specific
time intervals, monitoring each Corrective Action
Plan to ensure continuous effectiveness;
- Corrective Action Plans: ARC written plans
that address the findings set forth in Analysis
and Investigation Reports, that establish a course
of action to correct and prevent recurrence of system
(systemic) problems, and that confirm or correct
determinations in Analysis and Investigation Reports regarding
the release for distribution of unsuitable blood and blood
components;
- days: calendar days;
- DDR: Donor Deferral Registry;
- DMS: Data Management System;
- donor file check: a list of donors not properly
identified for deferral in the NDDR, which ARC
Biomedical Headquarters distributes to regions to
determine whether any of those donors donated during
a specified time period when the donors should have
been deferred;
- duplicate or discrepant records: multiple
donor records for the same donor which, because of
inconsistent or duplicated information, may result
in the release for distribution of unsuitable blood
components;
- equipment: all equipment used to collect,
manufacture, process, pack, hold, or distribute blood or blood
components;
- equipment qualification: verification that
the equipment is installed and will consistently operate
according to written and pre-approved specifications
throughout all specified operating ranges;
- equipment validation: documented evidence
that provides a high degree of assurance that equipment will
consistently operate within established limits and
tolerances;
- FDA-483 observation: a condition or practice,
relating to blood or blood components and/or
to collecting, manufacturing, processing, packing,
storing, or distributing blood or blood
components, that an FDA investigator observed
during an inspection and reported in writing to ARC management
at the conclusion of the inspection, in accordance
with 21 U.S.C. § 374(b);
- FDA-483s: the forms on which FDA investigators
record their FDA-483 observations;
- FD&C Act: Federal Food, Drug, and Cosmetic
Act, 21 U.S.C. § 301, et seq.;
- internal deviation reports: internal ARC reports
in any form, including hotline reports, that memorialize
or indicate ARC deviations from the law, ARC SOPs,
or this Order;
- invalid donor record: a donor record with
improper characters or blanks that may result in release
for distribution of unsuitable blood or blood
components;
- laboratories/laboratory: ARC's National
Testing and Reference Laboratory, ARC's National
Testing Laboratories, ARC's regional Immunohematology
Reference Laboratories, and ARC's National
Confirmatory Testing Laboratory;
- the law: FD&C Act, PHS Act, and all relevant
regulations;
- lookback: the steps taken to track unsuitable
blood or blood components and to notify consignees when
a previous donor subsequently tests positive for
infectious disease markers;
- MACS: Manufacturing and
Computer Standardization;
- NBCS: National Biomedical Computer System;
- NDDR: National Donor Deferral Register;
- penalty, review, and appeal procedures:
the procedures for penalties, FDA review, and Court
appeal set forth in paragraph IX of this Order;
- PHS Act: Public Health Service Act, 42 U.S.C. § 201, et
seq.;
- post donation information: information received
by ARC after a donation that was not previously
provided to ARC and not required to be solicited
by ARC during the donation, and that indicates
that the blood and blood components collected
from the donor are unsuitable;
- potential system (systemic) problem: a problem that
may have an adverse impact on donor or recipient safety
or the purity of blood or blood
components and that may affect more than one ARC region and/or laboratory;
- problem: any deviation from the law, ARC
SOPs, or this Order, however discovered, recorded,
or reported, including, but not limited to deviations
reported in ARC Clarify reports (and/or
in any other successor or similar deviation-reporting
systems and/or reports), biological product deviation reports, internal
deviation reports, trends, adverse
reaction reports, lookback cases, cases
of suspected transfusion-transmitted disease, potential
system (systemic) problems, system (systemic)
problems, supply and equipment problem
reports, FDA-483s, compliance-related FDA
correspondence, internal and external audit reports,
and retrievals;
- Problem Management SOPs: the SOPs required
by paragraph IV.B.1 of this Order;
- Problem Management Systems: systems used
by ARC regions and laboratories to
log, track, and trend all problems;
- procedures for SOP, report, and plan submission,
review, and implementation: the procedures set
forth in paragraph VI of this Order;
- purity: actual or purported safety,
quality, identity, potency, and purity of blood or blood
components as defined in the law;
- QA/QC program: written SOPs for
quality assurance and quality control that ARC must
establish, implement, and continuously maintain under
paragraph IV of this Order to ensure that blood and blood
components are collected, manufactured,
processed, packed, held, and distributed by ARC in
accordance with the law, ARC SOPs,
and this Order, and have the purity that
they purport or are represented to possess;
- region: all donor centers, mobile units,
processing centers, and distribution centers within
each ARC-designated geographical region;
- retrievals: recalls, market withdrawals,
and other actions taken to remove unsuitable blood and/or blood
components from the marketplace;
- SOPs: ARC standard operating procedures,
including, but not limited to, BSDs, BSLs,
regional and local standard operating procedures, and
any other written instructions used by ARC in
connection with the collection, manufacture, processing,
packing, holding, or distribution of blood and blood
components;
- Summary Problem Reports: reports to ARC
Biomedical Headquarters by all ARC regions and laboratories describing
all categories of problems that occurred
since the last such report and all categories of problems that
occurred prior to the last such report but that have
not been fully corrected;
- suspected transfusion transmitted disease: a
clinically significant infection or infectious disease
identified in a recipient of blood or of a blood
component that may have resulted from transfusion
and for which another, more likely cause is not apparent
after an investigation;
- system (systemic) problem: a problem that
results from a defect in ARC policies, procedures, equipment, or
supplies and affects either more than one ARC region and/or laboratory, or
warrants corrective action which, when implemented,
could affect more than one ARC region and/or laboratory;
- trend: the recurrence or multiple contemporaneous
occurrences of the same or similar problems in
one or more than one ARC region and/or laboratory;
- unsuitable blood or blood components: blood and/or blood
components for which the actual or purported purity has
or may have been compromised;
- utility programs: all computer software
programs designed for any computer system to identify duplicate,
discrepant, or invalid donor records.
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