Administering Files, Records, and Grants
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References.docxReferences
1. Resolution WHA 58.13. Blood safety: proposal to establish World Blood Donor Day. In: Fifty-eighth World Health Assembly. Geneva, World Health Organization, 2005.
2. Requirements for the collection, processing and quality control of blood, blood components and plasma derivatives. In: WHO Expert Committee on Biological Standardization, Forty-third Report. Geneva, World Health Organization, 1994; Annex 2 (WHO Technical Report Series, No. 840).
3. WHO Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. In: WHO Expert Committee on Biological Standardization. Fifty-second Report. Geneva, World Health Organization, 2004, Annex 4 (WHO Technical Report Series, No. 924).
4. Piet MP et al. The use of trin-(butyl)phosphate detergent mixtures to inactivate hepatitis viruses and human immunodefi ciency virus in plasma and plasma’s subsequent fractionation. Transfusion, 1990, 30:591–598.
5. Ala F, Burnouf T, El-Nageh M. Plasma fractionation programmes for developing economies. Technical aspects and organizational requirements. Cairo, WHO Regional Publications, 1999 (Eastern Mediterranean Series).
6. Prowse C. Plasma and Recombinant Blood Products in Medical Therapy — Appendix 1. Chichester, John Wiley & Sons, 1992.
7. Burnouf T, Radosevich M. Reducing the risk of infection from plasma products: specifi c preventative strategies. Blood Reviews, 2000, 14:94–110.
8. Kreil TR. West Nile virus: recent experience with the model virus approach. Developments in Biologicals, 2004, 118:101–105.
9. Remington K et al. Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma-derived products. Vox Sanguinis, 2004, 87:10–18.
10. Schmidt I et al. Parvovirus B19 DNA in plasma pools and plasma derivatives. Vox Sanguinisuinis, 2001, 81:228.
11. Blumel J et al. Parvovirus B19 transmission by heat-treated clotting factor concentrates. Transfusion, 2002, 42:1473–1481.
12. Committee for Medicinal Products for Human Use. Guideline on the scientifi c data requirements for a plasma master fi le (PMF). London, European Medicine Evaluation Agency, 2004 (EMEA/CPMP/BWP/3794/03) (http://www.emea.eu.int).
13. Anonymous. Guide to the preparation, use and quality assurance of blood components. 13th ed. Strasbourg, Council of Europe Publishing, 2007.
14. Sarkodie F et al. Screening for viral markers in volunteer and replacement blood donors in West Africa. Vox Sanguinis, 2001, 80:142–147.
15. Pereira A, Sanz C, Tassies D, Ramirez B. Do patient-related blood donors represent a threat to the safety of the blood supply? Haematologica, 2002, 87:427–433.
16. Roth WK et al. NAT for HBV and anti-HBc testing increase blood safety. Transfusion, 2002, 42:869–875.
17. Tabor E. The epidemiology of virus transmission by plasma derivatives:
clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1. Transfusion, 1999, 39:1160–1168.
18. Wang B et al. Prevalence of transfusion-transmissible viral infections in fi rsttime US blood donors by donation site. Transfusion, 2003, 43:705–712.
19. Dodd RY, Notari EP, Stramer SL. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion, 2002, 42:975–979.
20. Watanabe KK, Williams AE, Schreiber GB, Ownby HE. Infectious disease markers in young blood donors. Retrovirus Epidemiology Donor Study. Transfusion, 2000, 40:954–960.
21. Muller-Breitkreutz K, Evers T, Perry R. Viral marker rates among unpaid blood donors in Europe decreased from 1990 to 1996. Euro Surveillance, 1998, 3:71–76.
22. Committee for Medicinal Products for Human Use. Guideline on epidemiological data on blood transmissible infections. For inclusion in the guideline on the scientifi c data requirements for a plasma master fi le. London, European Medicine Agency, 2005 (EMEA/CPMP/BWP/3794/03: EMEA/CPMP/BWP/125/04) (http://www.emea.eu.int).
23. Hellstern P et al. The impact of the intensity of serial automated plasmapheresis and the speed of deep-freezing on the quality of plasma. Transfusion, 2001, 41:1601–1605.
24. Runkel S, Haubelt H, Hitzler W, Hellstern P. The quality of plasma collected by automated apheresis and of recovered plasma from leukodepleted whole blood. Transfusion, 2005, 45:427–432.
25. Burnouf T, Kappelsberger C, Frank, K, Burkhardt T. Protein composition and activation markers in plasma collected by three apheresis procedures. Transfusion, 2003, 43:1223–1230.
26. Anonymous. Monograph of human plasma for fractionation 01/2005:0853 corrected. European Pharmacopoeia, Strasbourg, 2005.
27. Pink J, Thomson A, Wylie B. Infectious disease markers in autologous and directed donations. Transfusion Medicine, 1994, 4:135–138.
28. de Wit HJ, Scheer G, Muradin J, van der Does J. A. Infl uence of the primary anticoagulant on the recovery of factor VIII in cryoprecipitate. Vox Sanguinis, 1986, 51:172–175.
29. Griffi n B, Bell K, Prowse C. Studies on the procurement of blood coagulation factor VIII. In vitro studies on blood components prepared in half-strength citrate anticoagulant 18 hours after phlebotomy. Vox Sanguinis, 1988, 55:9–13.
30. Prowse C, Waterston YG, Dawes J, Farrugia A. Studies on the procurement of blood coagulation factor VIII in vitro studies on blood components prepared in half-strength citrate anticoagulant. Vox Sanguinis, 1987, 52:257–264.
31. Rock G, Tittley P, Fuller V. Effect of citrate anticoagulants on factor VIII levels in plasma. Transfusion, 1988, 28:248–253.
32. Beeck H et al. The infl uence of citrate concentration on the quality of plasma obtained by automated plasmapheresis: a prospective study. Transfusion, 1999, 39:1266–1270.
33. Burgstaler EA. Blood component collection by apheresis. Journal of Clinical Apheresis, 2006, 21:142–151.
34. Burgstaler EA. In: McLeod BC, Price TH, Weinstein R, eds. Apheresis: Principles and Practice. 2nd ed. AABB Press, 2003:95.
35. Burnouf T, Kappelsberger C, Frank K, Burkhardt T. Residual cell content in plasma from 3 centrifugal apheresis procedures. Transfusion, 2003, 11:1522–1526.
36. Smith JK. Quality of plasma for fractionation–does it matter? Transfusion Science, 1994, 15:343 –350.
37. O’Neill EM. Effect of 24-hour whole-blood storage on plasma clotting factors. Transfusion, 1999, 39:488 –491.
38. Hurtado C et al. Quality analysis of blood components obtained by automated buffy-coat layer removal with a top & bottom system (Optipress (R)II). Haematologica, 2000, 85:390–395.
39. Pietersz RN et al. Storage of whole blood for up to 24 hours at ambient temperature prior to component preparation. Vox Sanguinis, 1989, 56:145–150.
40. Hughes C et al. Effect of delayed blood processing on the yield of factor VIII in cryoprecipitate and factor VIII concentrate. Transfusion, 1988, 28:566–570.
41. Carlebjork G, Blomback M, Akerblom O. Improvement of plasma quality as raw material for factor VIII:C concentrates. Storage of whole blood and plasma and interindividual plasma levels of fi brinopeptide A. Vox Sanguinis, 1983, 45:233–242.
42. Nilsson L, Hedner U, Nilsson IM, Robertson B. Shelf-life of bank blood and stored plasma with special reference to coagulation factors. Transfusion, 1983, 23:377–381.
43. Cardigan R, Lawrie AS, Mackie IJ, Williamson LM. The quality of freshfrozen plasma produced from whole blood stored at 4 degrees C overnight. Transfusion, 2005, 45:1342 –1348.
44. Hogman CF, Johansson A, Bergius B. A simple method for the standardization of centrifugation procedures in blood component preparation. Vox Sanguinis, 1982, 43:266–269.
45. Hogman CF, Eriksson L, Ring M. Automated blood component preparation with the Opti system: three years’ experience. Beitr Infusionstherapie, 1992, 30:100–107.
46. Hogman CF, Eriksson L, Hedlund K, Wallvik J. The bottom and top system: a new technique for blood component preparation and storage. Vox Sanguinis, 1988, 55:211–217.
47. Kretschmer V et al. Improvement of blood component quality--automatic separation of blood components in a new bag system. Infusionstherapie, 1988, 15:232–239.
48. van der Meer P et al. Automated separation of whole blood in top and bottom bags into components using the Compomat G4. Vox Sanguinis, 1999, 76:90–99.
49. Pietersz RN, Dekker WJ, Reesink HW. Comparison of a conventional quadruple-bag system with a ‘top-and-bottom’ system for blood processing. Vox Sanguinis, 1990, 59:205–208.
50. Masse M. Universal leukoreduction of cellular and plasma components:
process control and performance of the leukoreduction process. Transfusion clinique et biologique, 2001, 8:297–302.
51. Seghatchian J. Universal leucodepletion: an overview of some unresolved issues and the highlights of lessons learned. Transfusion and Apheresis Science, 2003, 29:105–117.
52. Gregori L et al. Effectiveness of leucoreduction for removal of infectivity of transmissible spongiform encephalopathies from blood. Lancet, 2004, 364:529–531.
53. Chabanel A et al. Quality assessment of seven types of fresh-frozen plasma leucoreduced by specifi c plasma fi ltration. Vox Sanguinis, 2003, 85:250.
54. Cardigan R. The effect of leucocyte depletion on the quality of fresh-frozen plasma. Br J Haematol, 2001, 114:233–240.
55. Runkel S et al. The impact of two whole blood inline fi lters on markers of coagulation, complement and cell activation. Vox Sanguinis, 2005, 88:17–21.
56. Smith JF, Ness PM, Moroff G, Luban NL. Retention of coagulation factors in plasma frozen after extended holding at 1-6 degrees C. Vox Sanguinis, 2000, 78:28–30.
57. Swärd-Nilsson A-M, Persson P-O, Johnson U, Lethagen S. Factors infl uencing Factor VIII activity in frozen plasma. Vox Sanguinis, 2006, 90:33–39.
58. Farrugia A. Plasma for fractionation: safety and quality issues. Haemophilia, 2004, 10: 334–340.
59. Fekete M, Kovacs M, Tollas G. The circumstances of freezing in the freezedrying process of haemoderivatives. Annales immunologiae Hungaricas, 1975, 18:229–236.
60. Myllyla G. Factors determining quality of plasma. Vox Sanguinis, 1998, 74:507–511.
61. Farrugia A, Prowse C. Studies on the procurement of blood coagulation factor VIII: effects of plasma freezing rate and storage conditions on cryoprecipitate quality. Journal of Clinical Pathology, 1985, 38:433–437.
62. Farrugia A. Factor VIII/von Willebrand factor levels in plasma frozen to -30 degrees C in air or halogenated hydrocarbons. Thrombosis Research, 1992, 68:97–102.
63. Akerblom O. Freezing technique and quality of fresh-frozen plasma. Infusionstherapie und Transfusionsmedizin, 1992, 19:283–287.
64. Carlebjork G, Blomback M, Pihlstedt P. Freezing of plasma and recovery of factor VIII. Transfusion, 1986, 26:159–162.
65. International Forum — What are the critical factors in the production and quality control of frozen plasma intended for direct transfusion or for fractionation to provide medically needed labile coagulation factors? Vox Sanguinis, 1983, 44:246–259.
66. Rock GA, Tittley P. The effects of temperature variations on cryoprecipitate. Transfusion, 1979, 19:86–89.
67. Kotitschke R et al. Stability of fresh frozen plasma: results of 36month storage at -20°C, -25°C, -30°C and -40°C. Infusionstherapie und Transfusionsmedizin, 2000, 27:174–180.
68. Buchta C, Macher M, Hocker P. Potential approaches to prevent uncommon hemolytic side effects of AB0 antibodies in plasma derivatives. Biologicals, 2005, 33:41–48.
69. Pepper MD, Learoyd PA, Rajah S.M. Plasma factor VIII, variables affecting stability under standard blood bank conditions and correlation with recovery in concentrates. Transfusion, 1978, 18:756–760.
70. Foster PR. Control of large-scale plasma thawing for recovery of cryoprecipitate factor VIII. Vox Sanguinis, 1982, 42:180–189.
71. PIC/S. PIC/S GMP guide for blood establishments. PE005-2, Pharmaceutical Inspection Convention 2004.
72. Guidelines for national authorities on quality assurance for biological products. In: WHO Expert Committee on Biological Standardization, Forty-second Report. Geneva, World Health Organization, 1992; Annex 2 (WHO Technical Report Series, No. 822).
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