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American National Red Cross/Biomedical Services, Washington, D.C., April 15, 2003, Amended Consent Decree

AMERICAN NATIONAL RED CROSS CONSENT DECREE

Note: Although this is an accurate representation of the original consent decree issued to the organization, it is not an exact copy. Slight modifications to the original decree have been made to accommodate its conversion to the HTML format. A scanned copy of the original letter is available in PDF at the bottom of this page.

 
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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

 

UNITED STATES OF AMERICA,
PLAINTIFF,
v.
AMERICAN NATIONAL RED CROSS
a corporation,
DEFENDANT.

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,

Civil No. 93-0949 (JGP)
AMENDED CONSENT
DECREE OF
PERMANENT INJUNCTION

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:

  1. The definitions in this paragraph apply throughout the Order. Defined terms are italicized when used in the Order.
  2. Defined Terms:
    1. 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);
    2. 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;
    3. 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;
    4. Analysis and Investigation Reports: reports written by the Analysis and Investigation Group that identify and analyze trends and system problems;
    5. 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;
    6. ARC Biomedical Headquarters: The ARC components that oversee the collection, manufacturing, processing, packing, and distribution of blood and blood components in all ARC facilities;
    7. 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;
    8. 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;
    9. ARC National Headquarters: The ARC component that oversees ARC Biomedical Headquarters and all other ARC national non-blood health and safety services programs;
    10. 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;
    11. audit SOPs: standard operating procedures governing ARC internal audits;
    12. 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;
    13. 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);
    14. 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;
    15. 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;
    16. BSDs: ARC Blood Services Directives;
    17. BSLs: ARC Blood Services Letters;
    18. business days: Monday through Friday, excluding federal holidays;
    19. CGMP: current good manufacturing practice;
    20. 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;
    21. CMV: cytomegalovirus;
    22. 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;
    23. 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;
    24. 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;
    25. 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;
    26. 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;
    27. 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;
    28. 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;
    29. days: calendar days;
    30. DDR: Donor Deferral Registry;
    31. DMS: Data Management System;
    32. 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;
    33. 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;
    34. equipment: all equipment used to collect, manufacture, process, pack, hold, or distribute blood or blood components;
    35. equipment qualification: verification that the equipment is installed and will consistently operate according to written and pre-approved specifications throughout all specified operating ranges;
    36. equipment validation: documented evidence that provides a high degree of assurance that equipment will consistently operate within established limits and tolerances;
    37. 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);
    38. FDA-483s: the forms on which FDA investigators record their FDA-483 observations;
    39. FD&C Act: Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq.;
    40. 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;
    41. invalid donor record: a donor record with improper characters or blanks that may result in release for distribution of unsuitable blood or blood components;
    42. 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;
    43. the law: FD&C Act, PHS Act, and all relevant regulations;
    44. 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;
    45. MACS: Manufacturing and Computer Standardization;
    46. NBCS: National Biomedical Computer System;
    47. NDDR: National Donor Deferral Register;
    48. penalty, review, and appeal procedures: the procedures for penalties, FDA review, and Court appeal set forth in paragraph IX of this Order;
    49. PHS Act: Public Health Service Act, 42 U.S.C. § 201, et seq.;
    50. 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;
    51. 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;
    52. 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;
    53. Problem Management SOPs: the SOPs required by paragraph IV.B.1 of this Order;
    54. Problem Management Systems: systems used by ARC regions and laboratories to log, track, and trend all problems;
    55. procedures for SOP, report, and plan submission, review, and implementation: the procedures set forth in paragraph VI of this Order;
    56. purity: actual or purported safety, quality, identity, potency, and purity of blood or blood components as defined in the law;
    57. 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;
    58. region: all donor centers, mobile units, processing centers, and distribution centers within each ARC-designated geographical region;
    59. retrievals: recalls, market withdrawals, and other actions taken to remove unsuitable blood and/or blood components from the marketplace;
    60. 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;
    61. 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;
    62. 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;
    63. 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;
    64. trend: the recurrence or multiple contemporaneous occurrences of the same or similar problems in one or more than one ARC region and/or laboratory;
    65. unsuitable blood or blood components: blood and/or blood components for which the actual or purported purity has or may have been compromised;
    66. utility programs: all computer software programs designed for any computer system to identify duplicate, discrepant, or invalid donor records.
 
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