a biannual inspection by AABB volunteers. The major intent of the I&A program is to increase the safety in obtaining and transfusing human blood and components. The program is also designed to assist directors of blood banks and transfusion services to determine that knowledge, equipment, and the physical plant meet established requirements; to detect deficiencies in practice; and to provide consultation for their correction. The I&A program can be used to eliminate duplicate inspections by state governments. Many states accept AABB inspection of blood banks and transfusion services to satisfy their licensing requirements. The US Armed Services and Humana, Inc., also maintain an equivalency program with the AABB. The AABB has established a coordinated inspection program with the CAP in which the CAP and AABB inspections are usually done simultaneously.
College of American Pathologists Accreditation Program
The CAP, through its Hospital Laboratory Accreditation Program (HLAP), also certifies hospital blood banks, but not community blood centers. The HLAP was initiated in 1961 with the primary objective of improving the quality of clinical laboratory services throughout the United States. The HLAP has grown considerably in size, complexity, and effectiveness since its inception, but the primary goal remains that of laboratory improvement through voluntary participation, professional peer review, education, and compliance with established performance standards. The CAP accredits approximately 4,300 laboratories throughout the United States, as well as several foreign countries.
The HLAP examines all aspects of quality control and quality assurance in the laboratory, including test methodologies, reagents, control media, equipment, specimen handling, procedure manuals, test reporting, and internal and external proficiency testing and monitoring, as well as personnel safety and overall management practices that distinguish a quality laboratory.
References
1 1. Global Status Report on Blood Safety and Availability. Geneva: World Health Organization (WHO), Department of Essential Health Technologies Blood Transfusion Safety Unit, 2016.
2 2. Aide‐Memoire for Ministries of Health. WHO/BCT/02. 03. Geneva: World Health Organization, July 2011.
3 3. Dhingra N. The blood supply worldwide. In: Lozano M, Contreras M, Blajchman M, eds. Global Perspectives in Transfusion Medicine. Bethesda, MD: American Association of Blood Banks Press, 2006.
4 4. McCullough J. National blood programs in developed countries. Transfusion 1996; 36:1019–1032.
5 5. National Blood Transfusion Services, Blood Transfusion Safety, Programs and Projects. Geneva, Switzerland: World Health Organization.
6 6. Martinez C, Vinelli E. Setting transfusion standards in developing countries: A Latin American perspective. In: Lozano M, Contreras M, Blajchman M, eds. Global Perspectives in Transfusion Medicine. Bethesda, MD: American Association of Blood Banks Press, 2006, pp. 128–144.
7 7. Dybul M. Partnerships for blood safety in Africa: the US President’s emergency plan for AIDS relief. Transfusion 2008; 48:1044–1046.
8 8. Nyamongo J, Mvere D. A letter from Kenya. Transfusion 2008; 48:1262 (letter to the editor).
9 9. Senyana F, Adams CL. A letter from Rwanda. Transfusion 2008; 48:1263 (letter to the editor).
10 10. Mpuntsha L, Heyns A, Camera S. A letter from South Africa. Transfusion 2008; 48:1263–1264 (letter to the editor).
11 11. Makuwani A, Ndugulile F, Mkapa T, et al. A letter from Tanzania. Transfusion 2008; 48:1265 (letter to the editor).
12 12. Chambo EL, Salimo S, Zefanias E, et al. A letter from Mozambique. Transfusion 2008; 48:1266–1267 (letter to the editor).
13 13. Voluntary Blood Donation, Blood Transfusion Safety, Programs and Projects. Geneva, Switzerland: World Health Organization.
14 14. World Health Organization. Blood Safety and Donation. Geneva: World Health Organization, Department of Essential Health Technologies Blood Transfusion Safety Unit, https://www.who.int/mediacentre/factsheets/fs279/en/index.html (accessed June 6, 2016).
15 15. World Health Organization. Blood Safety Survey, fact sheet no. 279, June 2011. Available from: https://www.who.int/worldblooddonorday/media/who_blood_safety_factsheet_2011.pdf (accessed June 21, 2016).
16 16. Dhingra N. Blood safety in the developing world and WHO initiatives. Vox Sang 2002; 83:173–177.
17 17. Allain JP, Sarkodie F, Asenso‐Mensah K, Owusu‐Ofori. Blood donors and blood collection—relative safety of first‐time volunteer and replacement donors in West Africa. Transfusion 2009; 50:340–343.
18 18. Eastlund T. Monetary blood donation incentives and the risk of transfusion‐transmitted infection. Transfusion 1998; 38:874–882.
19 19. Pruett CR, Vermeulen M, Zacharias P, et al. The use of rapid diagnostic tests for transfusion infectious screening in Africa: a literature review. Transf Med Rev 2015; 29(1):35–44.
20 20. Voak D, Caffrey EA, Barbara JAJ, et al. Affordable safety for the blood supply in developed and developing countries. Transfus Med 1998; 8:73–76.
21 21. Gibbs WN, Corcoran P. Blood safety in developing countries. Vox Sang 1994; 67:377–381.
22 22. Blood Transfusion Safety, Programs and Projects. Geneva, Switzerland: World Health Organization.
23 23. AuBuchon JP, Custer B, Sher G. A comparison of health care and blood supply system structures. Vox Sang 2011; 100(1):22–35.
24 24. WHO Expert Group. Expert consensus statement on achieving self‐sufficiency in safe blood and blood products, based voluntary non‐remunerated blood donation (VNRBD). Vox Sang 2012; 103:337–342.
25 25. Rajbhandary S, Whitaker B, Perez G. The 2014‐2015 AABB blood collection, and utilization, survey report. Bethesda, MD: American Association of Blood Banks, October 21, 2018.
26 26. Jones J. National Blood Collection and Utilization in the United States, 2017; Office of Blood, Organ and Other Tissue Safety, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infections Diseases Centers for Disease Control and Prevention. Presented at AABB Annual Meeting, Boston, October 15, 2018.
27 27. McCullough J. The continuing evolution of the nation’s blood supply system. Am J Clin Pathol 1996; 105:689–695.
28 28. Solomon JM. The evolution of the current blood banking regulatory climate. Transfusion 1994; 34:272–277.
29 29. Zuck TF. Current good manufacturing practices. Transfusion 1995; 35:955–966.
30 30. Joseph BG, Hendry C, Walsh TS. Red blood cell use outside the operating theater: a prospective observational study with modeling of potential blood conservation during severe blood shortages. Transfusion 2009; 49:2060–2069.
31 31. Bowman R, Clay M, Therkelsen D, et al. Donor attitudes about exporting and importing blood. Transfusion. 1997; 37:913–930.
32 32. Cohn EJ, Oncley JL, Strong LE, et al. Chemical, clinical, and immunological studies on the products of human plasma fractionation. J Clin Invest 1944; 23:417–606.
33 33. Lamb M. Source plasma: future outlook. Transfusion 2009; 49:1520–1526.
34 34. Burnouf T. Modern fractionation. Transfus Med Rev 2007; 21:101–117.
35 35. Plasma Protein Therapeutics Association. Available from: https://www.pptaglobal.org/.
36 36. Code of Federal Regulations, Subchapter F, 640.60; 1992.
37 37. Plasma Protein Therapeutics Association. Plasma Collection. Available from: https://www.pptaglobal.org/plasma (accessed August 2020).