implicated in HIV transmission, 2, 68, 208

and plasma pooling, 1, 19, 31

recalls, 7, 58, 148, 149, 164

reducing use of, 182-185, 200, 202

risk disclosure, 8, 231

substitution with cryoprecipitate, 4, 71, 175, 176, 177, 181-182, 250, 251

surveillance programs, 67

viral inactivation, 4, 5, 57, 76, 81-82, 86-97, 154-158, 177

Anti-inhibitor complex, 32, 303

Armor Pharmaceutical, 87, 92, 96

Assistant Secretary for Health, 3, 11n, 42, 58, 77, 212, 218n

leadership changes and failures, 59, 213, 214

Autologous donation, 53, 106, 108, 177, 303

B

Baxter Healthcare, 30, 88, 92

recalls, 58, 180

Behringwerke, A.G., 86, 87-88, 93

Best practices, 12, 16, 221, 232-234

Biologics, 43-44, 303

Biologics Act, 43, 44, 47-48

Blood and plasma products, 25-34, 303

distribution and shortages, 33-34

regulation and licensing, 30, 47-48, 50

see also terms listed under Plasma derivatives and Whole blood products

Blood banks and centers, 1, 9, 19, 27, 29, 34-35, 78, 208, 221, 303

community, 19, 26, 29, 35, 36, 37-38, 53-54

denial of risk, 9, 211-212

and directed donation, 74-75

donor screening policies, 6, 78, 102, 106, 162, 208, 211

hospital, 26, 29, 35, 36

licensure and registration, 49-51, 52

marginal interventions, 215, 216, 227-228

standard operating procedures, 73, 108, 142

and surrogate testing, 6, 107

Blood Products Advisory Committee (BPAC), FDA, 3, 7, 26, 45-46, 94 , 135, 212, 213, 219

AHF recall meeting and recommendations, 58, 75, 137, 152-153, 210, 213

donor screening policies, 71, 77

and lookback tracing, 159

panel composition and expertise, 15, 46, 121, 126, 213, 229-230

and surrogate testing, 75, 119-121

Blood Safety Director, 11-12, 218-219

Blood shield laws, 2, 48-49, 139, 223-224

Blood transfusion, 1, 9, 19, 20, 21, 27, 51, 131, 208

early AIDS cases, 58, 63, 64, 65, 68-69

Glaser case, 190-191

HIV incidence among recipients, 1, 19, 21, 169

PHS recommendations, 73, 177

Bove, Joseph, 121, 148

Brandt, Edward, 77, 148, 149, 154

Bureau of Biologics, FDA, 44, 51

1982 meeting, 66, 248

and swine flu episode, 140, 153

C

Canterbury v. Spence, 198

Case reporting, 67

chronologies, 61-65

MMWR reports, 58, 59, 68, 248, 250

CCBC, see Council of Community Blood Centers

CDC, see Centers for Disease Control and Prevention

CD4:CD8 ratios, 68, 76, 117-118

Front Matter (R1-R14)

Executive Summary (1-18)

1 Introduction (19-24)

2 The U.S. Blood Supply System (25-56)

3 History of the Controversy (57-80)

4 Product Treatment (81-100)

5 Donor Screening and Deferral (101-134)

6 Regulations and Recall (135-168)

7 Risk Communication to Physicians and Patients (169-206)

8 Conclusions and Recommendations (207-236)

Appendixes (237-238)

A Individuals Interviewed by the Committee (239-242)

B Individuals Providing Oral and Written Testimony (243-246)

C Chronological Summary of Critical Events, NHF Communications, Knowledge Base, Risk Assessment, Clinical Options, and NHF Actions (247-262)

D Key Documents Provided to the Committee (263-302)

E Glossary of Acronyms and Terms (303-314)

F Committee and Staff Biographies (315-322)

Index (323-334)