BLOOD DONATION AND SAFETY OF THE COMMUNITY BLOOD SUPPLY

Courtesy of:
LEON SU, MD
CHIEF MEDICAL OFFICER, UNITED BLOOD SERVICES OF ARIZONA ASSISTANT PROFESSOR OF LABORATORY MEDICINE AND PATHOLOGY, MAYO CLINIC COLLEGE OF MEDICINE CLINICAL ASSISTANT PROFESSOR, DEPARTMENT OF PATHOLOGY, THE UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE - PHOENIX

OBJECTIVES
Overview of blood donation process

Review criteria to give blood

Discuss current infectious disease testing Discuss the risk of HIV transmission in the community blood supply

TYPES OF DONATION
Community Blood Center (For transfusion in patients at hospitals) Whole Blood
Produces
Packed red blood cells Fresh frozen plasma Random platelet

Apheresis
May produce
1-3 Apheresis platelets Fresh frozen plasma One or two units of red cells

Plasma Center Plasmapheresis Plasma used for medications that are derived from human plasma

OVERALL ELIGIBILITY ESTIMATES

U.S. population approximately 294 million < 18 years old: 81 million > 65 years old: 36 million 294 117 = ~177 million age-eligible donors (60% of population eligible, traditional estimates)

CURRENT ESTIMATES
Of the 177 million age eligible

Approximately 66 million expected loss due to deferrals (22% reduction in eligible donors) leaving 111 million eligible donors New estimates show only 38% of population eligible to donate

WHY DO WE DEFER?
Do No Harm Protect the recipient Protect the health of our donors Declare the past, diagnose the present, foretell the future; practice these acts. As to diseases, make a habit of two things-to help, or at least to do no harm.
Hippocrates (circa 400BC) Epidemics, Bk.I, Sect. XI

Ensure the efficacy/potency of the blood product

Protecting the community blood supply

Donor History Questionnaire

Donor Screening
Abbreviated Physical Exam

Infectious Disease Testing

Laboratory Testing

Other Testing

DONOR QUESTIONNAIRE
Screening by questionnaire - important step in protecting the safety of the blood supply Series of questions designed to minimize the adverse consequences to the blood donor and patient Identify elements of the donors medical history and behavior or events that put a donor at risk for transmitting disease or their own personal health at risk

DHQ - CATEGORIES OF QUESTIONS

Demographics/General Information Age Weight Last Donation Gender
Gender specific questions on sexual history History of pregnancy Risk of Transfusion related acute lung injury

DHQ - CATEGORIES OF QUESTIONS (CONTINUED)

Medical History General Health Received blood products or tissues Medications Vaccinations Infectious Disease Risk

INFECTIOUS DISEASE RISK QUESTIONS

HIV & Hepatitis High risk behavior that may increase ones risk for infectious disease transmission Examples: IV drug use, accepting money for sex, unregulated tattoo, etc Chagas Disease Malaria Creutzfeld-Jakob Disease (CJD)/vCJD

MSM DEFERRALS
Current indefinite deferral in US: men who have had sex with men since 1977

Controversial
Professional medical community (AMA, AABB and ABC) all favor change to current deferrals FDA position prevents change at the moment UK moved to one year deferral from last sexual contact starting Nov 7, 2011

CDC - ESTIMATED NUMBER OF DIAGNOSES OF HIV INFECTION, 2009

0% Male to Male (MSM) Sexual Contact IV Drug Use (IVDU) MSM + IVDU 57% 3% 9%
* Includes hemophilia, blood transfusion, perinatal exposure, and risk not reported or not identified.

31%

Heterosexual Contact Other *

N = 42,959

BASIC DONOR CRITERIA

United Blood Services AGE WEIGHT Standards/Regulations 17 years old with parental Conform to applicable consent state law, 16 years old > 110 lbs 10.5 ml/kg

TEMP
BLOOD PRESSURE

37.5 C (99.5 F)
90 to 180 mm Hg systolic 50 to 100 mm Hg diastolic 50-100 bpm 12.5 g/dl 38%

37.5 C (99.5 F)
180 mm Hg systolic 100 mm Hg diastolic 50-100 bpm 12.5 g/dl 38%

PULSE HGB/HCT

Timeline of blood safety

1900 Discovery of ABO groups 1915 Sodium citrate as an anticoagulant 1943 Introduction of acid citrate dextrose (ACD) solution 1971 Hepatitis B surface antigen (HBsAg) testing of donated blood begins.

1907 Crossmatching

1939/40 The Rh blood group system is discovered

1970 Blood banks move toward an allvolunteer blood donor system

Donor test screening takes off

1985 The first bloodscreening test to detect HIV is licensed 1989 HTLV I antibody testing of donated blood begins. 1992 Testing for HIV-2 antibodies is implemented 1999 Implementation of Nucleic Acid Amplification Testing (NAT)

1987 Implementation of hepatitis B core antibody (anti-HBc) and the alanine aminotransferase test (ALT).

1990 Introduction of first specific test for hepatitis C

1996 HIV p24 antigen testing of donated blood begins

GENERAL PRINCIPLES OF INFECTIOUS DISEASE SCREENING

Sensitive enough to capture all real infection Specific enough so that you dont defer too many donors due to false reactive Ways to detect infection Screen for donors immune response to an organism (antibody) Screen for the presence of the pathogen itself (antigen, dna/rna) In general, screening for the pathogen occurs earlier than screening for immune response

INFECTIOUS DISEASE TESTING

HIV-1, HIV-2 Hepatitis B & C HTLV-1, HTLV-2 Syphilis

CMV
Bacterial Detection West Nile Virus Chagas

HUMAN IMMUNODEFICIENCY VIRUS

HIV-1 & HIV-2 etiologic agents of AIDS AIDS syndrome first identified 1981 First transfusion transmitted case in 1982 in a 20 month old baby

Infects CD4 positive T lymphocytes

Initial course: Flu-like symptoms Persistent Infection can remain asymptomatic 1012 years without treatment Eventual development of opportunistic illnesses that characterize AIDS

HIV

DONOR TEST SCREENING

HIV 1/2 Antibody Enzyme immunoassay Confirmed by Western Blot/ Immunofluorescence Assay (IFA) Negative confirmatory unlicensed HIV-2 western blot Multiplex NAT HIV-1/HCV Discriminatory NAT HIV

HIV AB

HIV RNA ~ 22 days ~ 16 days ~ 10 days HIV p24 Ag

Modified from Mandell, Bennett, & Dolin: Principles and Practice of Infectious Diseases, 6th ed.

RECENT CASE OF TT-HIV

First U.S. case of transfusion-transmitted HIV since 2002 Man received a unit of FFP in 2008 Donor was a 40 y.o. male who donated whole blood in Missouri in 06/2008.
Had no reported risk factors for HIV EIA and MP-NAT negative Repeat blood donation in 11/2008, EIA, NAT and IFA positive

2 patients had received units from the donors june donation

1 patient was a cardiac surgery patient who received the pRBC. He died 2 days later due to cardiac related disease. 1 kidney transplant patient received the FFP unit He was tested in December 2008. EIA negative but detectable HIV RNA on PCR

-CONTINUED-

CDC sequenced the HIV DNA from donor and recipient and confirmed 99% identical
Donor revealed in a follow up by Missouri State Health that he was married but engaged in sex with both men and women outside the marriage, often anonymously and while he was drunk, including shortly before his June donation.

BLOOD SAFETY TODAY

Transfusion Transmitted Infections

Hepatitis B

1:300,000 1:357,000

Hepatitis C

~ 1:1,149,000

HIV

~ 1:1,467,000

Zou S, Stramer SL, Dodd RY. Donor testing and risk: current prevalence, incidence, and residual risk of transfusion-transmissible agents in US allogeneic donations. Transfus Med Rev 2011;Aug 24 Epub.