# Presentation: 534089

## American Red Cross,vCJD Donor Deferral Criteria, and Blood Supply

- Peter L. Page, MD
- Senior Medical Officer
- Biomedical Headquarters
- TSEAC 06/27/02

## Background 1

***March 2000:***  ARC initiated first vCJD deferrals
***Early 2001:***  ARC developed vCJD geographic donor deferral criteria, based upon concern and uncertainty about upcoming evolution of epidemic, stating policy would be reconsidered as new data accrue

## Background 2

***October 2001:***  ARC implemented its criteria
***January 2002:***  FDA issues final guidance to take effect 06/02 and 11/02

## Quick-reference summary of vCJD-related geographic donor deferral criteria as of 1/9/02

- 2	Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Republic of Ireland, Italy, Liechtenstein, Luxembourg, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Federal Republic of Yugoslavia.
- 3	Germany, Italy, Netherlands, Switzerland, Austria, Belgium, Spain, Republic of Ireland, Portugal, Denmark, Luxembourg and Liechtenstein

**Agency**

**In Effect:**

**UK**

**France**

**Europe Other Than France**

**Other Countries**

**Special Rules for US Military Base Personnel**

**FDA**

- 11/99-5/02

- 6 months, 1980-1996

- None

- None

- None

- None

**ARC**

- 11/99-9/01

- 6 months, 1980-1996

- None

- None

- None

- None

**ARC**

**10/01 forward**

- 3 months, 1980-present

- 6 months,1980-present

- 6 months,1980-present, all countries

- Gibraltar and Falklands same as UK; Oman same as Europe

- Same as country in which military base resides. NOTE: This implies there is not deferral for military staff on bases in Turkey

**FDA****1**

- 6/02-10/02

- 3 months, 1980-1996

- 5 years,1980-present

- None

- Gibraltar and Falklands same as UK

- 6 months from 1980-1990 for Germany, UK, Belgium and Netherlands;
- 6 months from 1980-1996 for Turkey, Spain, Portugal and Italy

**FDA****1**

**11/02 forward**

- 3 months, 1980-1996

- 5 years,1980-present

- 5 years, 1980-present, selected countries only2, except Source Plasma donors

- Gibraltar and Falklands same as UK

- 6 months from 1980-1990 for Germany, UK, Belgium and Netherlands;
- 6 months from 1980-1996 for Turkey, Spain, Portugal and Italy

**DoD**

- Same as FDA

- Same as FDA

- Same as FDA

- Same as FDA

- Same as FDA

- 6 months from 1980-1996 for bases anywhere in Europe or Turkey

**Hema Quebec**

- 9/01 forward

- 1 month,1980-present

- 3 months,
- 1980-present

- 6 months, Western Europe only3

- None

- None

**CBS**

- 10/01 forward

- 3 months,1980-present

- 3 months,
- 1980-present

- 5 years, 1980-present, Western Europe only3

- None

- None

## Differences in vCJD geographic deferrals: Ongoing ARC and recent/upcoming FDA

**ARC**

**FDA**

- Oman included
- US Military bases in specified European countries

- Yes
- ‘80-present6 monthsWhole country

- 1.	3 months in UK from

- ‘80-Present

- 2.	Time in Europe from 1980-present

- 6 months*(All European countries)*

- No
- ‘80-‘90 or -‘966 monthsOnly bases

- ‘80-‘96

- 5 years*(Some European countries)*

## 1. UK Deferral Criteria

- Ongoing ARC criteria:	 3 months, 1980-present
- Recent FDA criteria:	 3 months, 1980-1996
***ARC Plan:***** **In 11/02, change to FDA’s criteria (cut off at end of 1996)
***Rationale:***  Food chain controls implemented in UK by 1996 are now (2002) deemed to have been effective and sufficient.
***Results:***
- ARC consistent with FDA on this issue
- Individuals’ presence in the UK after 1996, after food controls in place, would not effect eligibility

## 2. Rest of Europe Deferral Criteria

- Ongoing ARC criteria:	 6 months for all countries
- Upcoming FDA criteria (11/02):	 5 years for most countries
***ARC Plan:*** No change
***Rationale:*** Continuing lack of active surveillance and effective food controls in some of those countries now better appreciated
***Results:***
- No operational change for ARC; avoid complexity of dealing with various U.S. bases

## ARC Experience

- Donor deferrals, and blood collections vs. goal
- Blood distribution and inventory

## vCJD Deferrals in October 2001

**Percent Deferred re vCJD**
*By Day*

- 6 months UK
- Bovine insulin

- 3 months UK
- 6 months rest of Europe
- Bovine insulin

**2001**

## vCJD Deferrals September 01– March 02

- vCJD Deferrals September 01– March 02

**Percent Deferred**
*By Week*

**2001**

**2002**

## Summary:vCJD Deferrals by Region and Time

**Time Period**

**Number of Donors Deferred re vCJD per Month**

**March 01**

**361**

**10/15 – 12/14/01***

**5,631**

**March 02**

**3,764**

- *New criteria started 10/15/01

## American Red Cross Blood Services Regions by Region Code and Customer Business Unit (CBU)

**Puerto Rico**

- 84

- 6

- 7

- 20

- 21

- 17

- 9

- 2

- 49

- 55

- 11

- 32

- 40

- 38

- 18

- 4

- 19

- 41

- 26

- 3

- 36

- 24

- 1

- 33

- 29

- 22

- 53

- 30

- 27

- 35

- 42

- 16

- 50

- 13

- 2

- 54

***South Central CBU***

***Western CBU***

***North Central CBU***

***North Atlantic CBU***

## vCJD Specific Donor Deferral Rates by RegionFor various time periods

- vCJD Specific Donor Deferral Rates by Region*For various time periods*

- North Atlantic

- North Central

- South Central

- Western

**Region Code**

**CBU:**

**3/01**	≥6 months UK, in place for 12 months
**10/15-12/14/01**	≥3 months UK, ≥6 months Europe, newly implemented
**3.02**	≥3 months UK, ≥6 months Europe, in place for 6 months

## Deferrals and Collections

**Deferral Rate**
**All Donors, All Reasons**
*By Month*

**WB Allogeneic Collections**
*By Month*

**August 2000**
**Switch from ear to finger sample, +4.5% deferral for hemoglobin**

## Distribution and Inventory

**Average Net Daily Distribution**
*By Month*

**Average Daily Inventory**
*By Month*

## Summary

- When anticipated and planned for, new donor deferral criteria can be accommodated by increased donor recruitment efforts
- After the increase in deferrals from a new measure, there is culling, and the deferral rate drops
- More regular volunteer blood donations continue to be needed to prevent seasonal shortages