Ensuring blood safety and availability in the US: Technological advances, costs, and challenges to payment - Final report

Transfusion

Volumn 43, Issue 8 SUPPL., 2003, Pages

  Goodman, Clifford ^a   Chan, Stephen ^a   Collins, Patricia ^a   Haught, Randall ^a   Chen, Ying Jun ^a  

^a LEWIN GROUP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SUBSTITUTE;

ARTICLE; BACTERIUM CONTAMINATION; BLOOD BANK; BLOOD COMPATIBILITY; BLOOD COMPONENT; BLOOD DONOR; BLOOD SAMPLING; BLOOD TRANSFUSION; CODING; DIAGNOSIS RELATED GROUP; HEALTH CARE COST; HEALTH CARE QUALITY; HOSPITAL COST; INFECTION RISK; MEDICARE; PARASITOSIS; PRACTICE GUIDELINE; PROSPECTIVE PAYMENT; PROSPECTIVE PRICING; REIMBURSEMENT; RISK ASSESSMENT; SAFETY; TECHNOLOGY; UNITED STATES; VIRUS TRANSMISSION;

EID: 0041887252     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.43.8s.2.x     Document Type: Article

References (108)

1. National Blood Data Resource Center (Internet). Bethesda: The Center; c2001. Available from: http://www.nbdrc.org
2. American Red Cross statement to the Food and Drug Administration's Transmissible Spongiform Encephalopathy Advisory Committee Re: variant Creutzfeldt-Jakob disease (Internet). Washington: American Red Cross; 2001 Jun 28. Available from: http://www.redcross.org/services/biomed/ blood/supply/tse/tseac2-062801.html
3. American Red Cross (Internet). Washington: American Red Cross; c2002. Available from: http://www.redcross.org
4. America's Blood Centers (Internet). Washington: The Centers; c2003. Available from: http://www.americasblood.org
5. Klein HG. Will blood transfusion ever be safe enough? JAMA 2000;2:238-40.
6. Ness PM. Transfusion medicine: an overview and update. Clin Chem 2000;8:1270-6.
7. Glynn SA, Kleinman SH, Shreiber GB, et al. Trends in incidence and prevalence of major transfusion-transmissible viral infections in US blood donors, 1991 to 1996. JAMA 2000;284:229-35.
8. American Association of Blood Banks (Internet). Bethesda: The Association; c2001. Available from: http://www.aabb.org/
9. Center for Biologics Evaluation and Research and American Association of Blood Banks Annual Meeting (Internet). Rockville (MD): Center for Biologics Evaluation and Research; 2001. Available from: http://www.fda.gov/cber/ meetings.htm
10. Pollack A. Approval of advanced blood screen will lift cost. The New York Times 2002 Mar 1.
11. Draft guidance for industry: use of nucleic acid tests on pooled and individual samples from donors of whole blood and blood components for transfusion to adequately and appropriately reduce the risk of transmission of HIV-1 and HCV (Internet). Rockville (MD): Center for Biologics Evaluation and Research; 2002 Mar 13. Available from: http://www.fda.gov/cber/gdlns/hivhcvnatbld.htm
12. Leukoreduction (Internet). Washington: American Red Cross; 2001. Available from: http://www.redcross.org/services/biomed/blood/supply/leukocyte.html
13. Circular of information for the use of human blood and blood components (Internet). Bethesda: American Association of Blood Banks, America's Blood Centers, American Red Cross; 2000. Available from: http://www.aabb.org/All_About_Blood/COI/coiv2.pdf
14. Hamilton J. All things considered (radio program). Washington: National Public Radio; 2001 Jul 12.
15. Cantor SB, Hudson DV Jr, Lichtiger B, Rubenstein EB. Costs of blood transfusion: a process-flow analysis. J Clin Oncol 1998;7:2364-70.
16. Burzik CM. OCD perspective on the state of the blood industry in the U.S. (presentation). Rochester (NY): Ortho-Clinical Diagnostics; 2001.
17. AABB comments to Blood Products Advisory Committee (Internet). Bethesda (MD): American Association of Blood Banks; 2001 Mar 15. Available from: http://www.aabb.org/ Pressroom/Press_Releases/pr031401.htm
18. Jacobs MR. Don't bug me: the problem of bacterial contamination of blood components-challenges and solutions. Transfusion 2001;11:1331-4.
19. Puget Sound Blood Center (Internet). Puget Sound (WA): The Center; c2001. Available from: http://www.psbc.org
20. JCAHO Standards for Ambulatory Care 2000-2001. Oakbrook Terrace (IL): JCAHO; 2001.
21. Popovsky MA, Chaplin HC Jr, Moore SB. Transfusion-related acute lung injury: a neglected, serious complication of hemotherapy. Transfusion 1992;32:589-92.
22. Holness L. Blood Products Advisory Committee (presentation). Rockville (MD): Center for Biologics Evaluation and Research; 2001 Jun. Available from: http://www.fda.gov/cber/advisory/bp/bp0601.htm
23. Zoon K. Letter: Transfusion related acute lung injury (Internet). Rockville (MD): Center for Biologics Evaluation and Research; 2001 Oct. Available from: http://www.fda.gov/cber/ltr/trali101901.pdf
24. Heddle NM, Kelton JG. Febrile non-hemolytic transfusion reactions. In: Popovsky MA, editor. Transfusion reactions. 2nd ed. Bethesda: American Association of Blood Banks; 2001.
25. Rayfield MA, Sullivan P, Bandea CI, et al. HIV-1 Group O virus identified for the first time in the United States (Internet). CDC Emerging Infectious Diseases Dispatch. Atlanta (GA): CDC; 1996 Jul-Sep. Available from: http://www.cdc.gov/ncidod/eid/vol2no3/rayfield.htm
26. Ruiz MS, Gable AR, Kaplan EH, et al, editors. No Time to lose: Getting more from HIV prevention. Institute of Medicine, Committee on HIV Prevention Strategies in the U.S. Washington: National Academy Press; 2001.
27. Press release: number of U.S. AIDS cases remain stable after recent declines (Internet). Atlanta: Centers for Disease Control and Prevention; 2002 Jul 7. Available from: http://www.cdc.gov/od/oc/media/pressrel/r020707.htm
28. American Association of Blood Banks: All about Blood (Internet). Bethesda: American Association of Blood Banks; c2001. Available from: http://www.aabb.org/ All_About_Blood/FAQs/aabb_faqs.htm#5
29. Busch M. FDA NAT Implementation Workshop. Rockville (MD): FDA; 2001 Dec.
30. Terrault N. Chronic viral hepatitis in the United States. American Association for the Study of Liver Diseases. Postgraduate course 2000. Quebec: HepNet; c2000. Available from: http://www.hepnet.com/hepc/aasld00/terrault.html
31. Satcher D. Testimony on immune globulin shortage (Internet). Surgeon General's statement at a hearing of the U.S. House of Representatives, Committee on Government Reform, Subcommittee on Human Resources (May 7, 1998). Available from: http://www.hhs.gov/asl/testify/t980507b.html
32. Finley AM. Protecting the nation's blood supply from infectious agents: the need for new standards to meet new threats. 10th Report by the Committee on Government Reform and Oversight (Aug. 2, 1996).
33. Blood usage facts (Internet). Washington: American Red Cross; c2002. Available from: http://www.redcross.org/ services/biomed/blood/supply/usagefacts.html
34. Orfinger B. "Mad cow" fears prompt advisory committee to recommend tighter blood donor restrictions (Internet). Washington: American Red Cross; 2001. Available from: http://www.redcross.org/news/bm/tse/ 010628madcow.html
35. Sullivan MT. US blood supply trends post-September 11, 2001 (Internet). Bethesda: National Blood Data Resource Center; 2002. Available from: http://www.nbdrc.org/news/ 2002/collectednov2001.htm
36. America's Blood Centers launches system to track blood supply levels. Washington: America's Blood Centers; 2002 Mar 25. Available from: http://www.americasblood.org/index.cfm?fuseaction=display.showPage&pageID= 205
37. Stricter blood donor guidelines going into effect May 31; America's Blood Centers could lose thousands of donations (Internet). Washington: America's Blood Centers; 2002. Available from: http://www.americasblood.org/ index.cfm?fuseaction=display.showPage & pageID=204
38. Altman LK. Linking West Nile and transplants may take weeks. New York Times 2002 Sep 2.
39. Weiss R. Organ recipients had virus. West Nile's presence also raises blood supply concerns. Washington Post 2002 Sep 4.
40. Dienstag JL, Alter HJ. Non-A, non-B hepatitis: evolving epidemiologic and clinical perspective. Semin Liver Dis 1986;6:67-81.
41. Donahue JG, Munoz A, Ness PM, et al. The declining risk of post transfusion hepatitis C virus infection. N Engl J Med 1992;327:369-73.
42. Sobel RK. A bloody mess. US News and World Report 2001 Sep 3:37-42.
43. Hoots WK, Abrams C, Tankersleydagger D. The impact of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease on plasma safety. Transfus Med Rev 2001;15:45-59.
44. Grady D. Briton in Florida has mad cow disease. New York Times. 2002 Apr 19.
45. Guidance for industry: revised preventive measure to reduce the possible risk of transmission of variant Creutzfeldt-Jakob disease (vCJD) by blood and blood products (Internet). Rockville (MD): Center for Biologics Evaluation and Research; 2001 Aug 27. Available from: http://www.fda.gov/cber/gdlns/cjdvcjd.htm
46. Dariotis J, MacPherson J, Bianco C. America's Blood Centers and the gift relationship. Transfusion 2001;10:1181-4.
47. Blood product safety and transmissible spongiform encephalopathies conference overview (Internet). Newton Upper Falls (MA): Cambridge Healthtech Institute; 2002. Available from: http://www.healthtech.com/2002/bss/index.htm
48. Ramsey G, Sherman LA. Blood component recalls in the United States. Transfusion 1999;39:473-8.
49. Kitchen AD. Which agents threaten blood safety in the future? Baillieres Best Pract Clin Haematol 2000;4:601-14.
50. Finberg RW. Epstein-Barr virus-specific T cells for the management of Epstein-Barr virus lymphomas. Curr Opin Oncol 2001;13:349-53.
51. Goldenberg D, Golz A, Netzer A, et al. Epstein-Barr virus and cancers of the head and neck. Am J Otolaryngol 2001;22:197-205.
52. Altman LK. Baffling hepatitis virus is isolated, scientists say. New York Times 1999 Jul 20.
53. Hepatitis G more common, more mild that hepatitis C (Internet). Quebec: HepNet; c1995-1997. Available from: http://www.hepnet.com/hepg/hgvnews2.html
54. Schreiber G, Busch M, Kleinman S, Korelitz J. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med 1996;26:1685-90.
55. FDA approves first nucleic acid test (NAT) system to screen whole blood donors for infections with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) (Internet). Rockville (MD): FDA; 2002 Feb 28. Available from: http://www.fda.gov/bbs/topics/ANSWERS/2002/ ANS01140.html
56. Stramer S. Testimony to Blood Products Advisory Committee Meeting. Washington: American Red Cross; 2002 Jun: 13-14.
57. Simmonds P, Kurtz J, Tedder RS. The UK blood transfusion service: over a (patent) barrel? Lancet 2002;359:1713-4.
58. Ratko TA, Cummings JP, Oberman HA, et al. Evidence-based recommendations for the use of WBC-reduced cellular blood components. Transfusion 2001;10:1310-9.
59. Guidance for industry: pre-storage leukocyte reduction of whole blood and blood components intended for transfusion (Internet). Rockville (MD): Center for Biologics Evaluation and Research; 2001 Jan. Available from: http://www.fda.gov/cber/gdlns/preleuk.htm
60. Reidner C, Heim MU, Mempel W, Wilmanns W. Possibility to improve preservation of whole blood by leukocyte-depletion before storage. Vox Sang 1990;59:78-82.
61. Murphy MF. New variant Creutzfeldt-Jakob disease (nvCJD): the risk of transmission by blood transfusion and the potential benefit of leukocyte-reduction of blood components. Transfus Med Rev 1999;13:75-83.
62. UHC expert panel develops recommendations for using leukocyte-reduced cellular components. Clinical Practice Alert. Vol. 7. Oak Brook (IL): University HealthSystem Consortium; 2000.
63. Nightingale SD. Universal WBC reduction. Transfusion 2001;10:1306-9.
64. Paxton A. Universal leukoreduction-fix or folly? CAP Today 2000;10:36-8, 40-2. Available from: http://www.cap.org/captoday/archive/2000/cov1000.html
65. Lazo A, et al. Inactivation of nonenveloped viruses in red blood cell concentrates using the INACTINE compound PEN110. American Society of Hematology 43rd Annual Meeting; 2001 Dec; Orlando (FL). Washington: American Society of Hematology; 2002.
66. Zavizion B, et al. Collection system equivalency using the INACTINE process for pathogen inactivation: bacterial inactivation assessment. 54th Annual Meeting of the American Association of Blood Banks; 2001 Oct 13-17; San Antonio (TX). Bethesda: American Association of Blood Banks; 2001.
67. Klein HG. Current status of solvent/detergent-treated frozen plasma. Transfusion 1998;38:102-7.
68. Lin L, Cook DN, Wiesehahn GP, et al. Photochemical inactivation of viruses and bacteria in platelet concentrates by use of a novel psoralen and long-wavelength ultraviolet light. Transfusion 1997;37:423-35.
69. Gulliksson H, AuBuchon JP, Vesterinen M, et al. Storage of platelets in additive solutions: a pilot in vitro study of the effects of potassium and magnesium. Vox Sang 2002;3: 131-6.
70. AuBuchon JP. Platelet transfusion therapy. Clin Lab Med 1996;16:797-816.
71. Paxton A. Blood banks step up move to automation. CAP Today 1999;10. Available from: http://www.cap.org/captoday/archive/1999/feat1_1099.html
72. Linden JV, Paul B, Dressler KP. A report of 104 transfusion errors in New York state. Transfusion 1992;32:601-6.
73. Immucor (Internet). Norcross (GA): Immucor; c1997-2003. Available from: http://www.immucor.com.
74. Winslow RM. Blood substitutes. Curr Opin Hematol 2002;2:146-51.
75. Ma Z, Monk TG, Goodnough LT, et al. Effect of hemoglobin-and Perflubron-based oxygen carriers on common clinical laboratory tests. Clin Chem 1997;9:1732-7.
76. Becker C. Budgets may get bloodied: American Red Cross plans to raise average price of blood nearly one-third. Mod Healthc 2001;21:8.
77. Medicare Payment Advisory Commission (MedPAC) Report to the Congress: Blood safety in hospitals and Medicare inpatient payment (Internet). Washington: MedPAC; 2001 Dec. Available from: http://www.medpac.gov/publications/ congressional_reports/dec2001BloodSafety.pdf
78. Lane J. Witness appearing before the Advisory Committee on Blood Safety and Availability of the Department of Health and Human Services. Washington: DHHS; 2000 Apr 26. Available from: http://www.hhs.gov/bloodsafety/ transcripts/20000426.html
79. Sarudi D. Blood feud. Hosp Health Netw 2000;74:50-6.
80. Estimate of the cost of reimbursing hospitals for further insuring the safety of the blood supply for Medicare beneficiaries (memo). Washington: Muse and Associates; 2000 Aug 9.
81. Financial impact of technologies to improve blood safety. Testimony by America's Blood Centers before Medicare Payment Advisory Commission (Internet). Washington: America's Blood Centers; 2001 Oct 19. Available from: http://66.155.15.152/advocacy/medpact.htm
82. DeJohn P. Hospitals deal with blood shortages, filtration costs. Hosp Mater Manage 2001;26:1, 9.
83. More blood cost increases on the horizon, experts say (Internet). AHA News Now. Chicago: HospitalConnect; 2002 Jan 1. Available from: http://www.hospitalconnect.com/ aha/jsp/display.jsp?dcrpath=AHA/NewsStory_Article/data/ aha_news_now/AHANEWSNOW611 & domain=AHANEWS
84. Muto S. State's blood banks find Medicare cuts run deep. Wall Street Journal (California edition) 2000 Jun 7.
85. Forbes JM, Anderson MD, Anderson GF, Bleecker GC, Rossi EC, Moss GS. Blood transfusion costs: a multicenter study. Transfusion 1991;4:318-23.
86. Cremieux PY, Barrett B, Anderson K, Slavin MB. Cost of outpatient blood transfusion in cancer patients. J Clin Oncol 2000;14:2755-61.
87. Red cell and whole blood cost data from 35 community blood centers, 1996-2000. Chicago: Zeman and Company.
88. Jefferies LC, Sachais BS, Young DS. Blood transfusion costs by diagnosis-related groups in 60 university hospitals in 1995. Transfusion 2001;41:522-9.
89. Medicare coverage issues manual, Section 222, Part A, blood deductible. Baltimore (MD): Centers for Medicare and Medicaid Services.
90. Program Memorandum Intermediaries Transmittal A-01-50, Change Request 1585 (Internet). Baltimore (MD): Centers for Medicare and Medicaid Services; 2001 Apr 12. Available from: http://cms.hhs.gov/manuals/pm_trans/A0150.pdf
91. Medicare coverage issues manual, Section 45-27, blood transfusions. Baltimore (MD): Centers for Medicare and Medicaid Services.
92. American Red Cross and Reimbursement, Hospital Charges for American Red Cross Blood and Blood Product Fees, HM 2-2 (Internet). Washington: American Red Cross; 2002 Jan.
93. DRG guidebook 2001. Reston (VA): St. Anthony Publishing; 2000.
94. DRG expert 2002. Reston (VA): St. Anthony Publishing; 2001.
95. Social Security Act, Section 1886 (b)(3)(B)(iii).
96. Centers for Medicare and Medicaid Services. Medicare program: changes to the hospital inpatient prospective payment system and fiscal year 2003 rates-proposed rule. Fed Regist 2002;67:90.
97. Segal JB, Ness PM, Powe NR. Validating billing data for RBC transfusions: a brief report. Transfusion 2001;41:530-3.
98. Letter to MedPAC regarding blood safety costs. Washington: American Association of Blood Banks, America's Blood Centers and American Red Cross; 2001 Nov 11.
99. Letter to MedPAC regarding blood safety costs. Washington: American Hospital Association; 2001 Nov 12.
100. Loubiere S, Rotily M, Durand-Zaleski I, Costagliola D. Including polymerase chain reaction in screening for hepatitis C virus RNA in blood donations is not cost-effective. Vox Sang 2001;80:199-204.
101. AuBuchon JP, Birkmeyer JD, Busch MP. Cost-effectiveness of expanded human immunodeficiency virus-testing protocols for donated blood. Transfusion 1997;37:45-51.
102. Pereira A, Sanz C. A model of the health and economic impact of posttransfusion hepatitis C: application to cost-effectiveness analysis of further expansion of HCV screening protocols. Transfusion 2000;40:1182-91.
103. Busch MP. Closing the windows on viral transmission by blood transfusion. In: Stramer SL, editor. Blood safety in the new millennium. AABB 2000 Emily Cooley Seminar Book. Bethesda: American Association of Blood Banks; 2001:33-54.
104. AuBuchon JP, Birkmeyer JD, Busch MP. Safety of the blood supply in the United States: opportunities and controversies. Ann Intern Med 1997;127:904-9.
105. Hewlett IK, Epstein JS. Food and Drug Adminstration conference on the feasibility of genetic technology to close the HIV window in donor screening. Transfusion 1997;37: 346-51.
106. Hewlett IK, Epstein JS. Food and Drug Administration conference on the feasibility of genetic technology to close the HIV window in donor screening. Transfusion 1997;37: 346-51.
107. Leveton LB, Sox HC Jr, Stoto M, editors. HIV and the blood supply: an analysis of crisis decisionmaking. Institute of Medicine, Committee to Study HIV Transmission Through Blood and Blood Products. Washington: National Academy Press; 1995.
108. Gallarda JL, Dragon E. Blood screening by nucleic acid amplification technology: current issues, future challenges. Mol Diagn 2000;51:11-22.