1. Public Workshop: Quarantine Release Errors in Blood Establishments September 13, 2011 QREs Past, Present and Future Sheryl A. Kochman Deputy Director Division of Blood Applications OBRR/CBER

2. 2 Overview ♦Reason for the Workshop ♦Definitions ♦Past ♦Present ♦Future

3. 3 Reason for the Workshop June 10-11, 2010, Meeting of the HHS Advisory Committee on Blood Safety and Availability (ACBSA) on FDA policy for MSM deferrals ♦The committee recommended several research initiatives to validate alternative policies ♦The committee also recommended: ♦The Department should take action to investigate and reduce the risk of Quarantine Release Errors (QREs) in blood collection establishments

4. 4 Definitions What’s a QRE? ♦QRE = Quarantine Release Error ♦Previously known as: ♦Release of unsuitable units ♦Errors and accidents ♦Erroneous releases

5. 5 Definitions (2) For purposes of this workshop: ♦the inadvertent release of blood or blood components either ♦before completion of testing and determination that all other criteria affecting the safety, purity or potency of the product have been met, ♦or despite findings that would render the blood or blood components unsuitable for release.

6. 6 In other words ♦The firm had information available to them at the time the unit was released that should have caused them to quarantine the unit pending further action but they released the unit nonetheless.

7. 7 PAST ♦In the late 1980s, there was a significant increase in the number of recalls of blood and blood components

8. 8 FDA’s Initial Responses ♦In 1988, FDA initiated 100% inspection of blood establishments ♦Between 1988 and 1993, FDA issued numerous Memorandums to Blood Establishments on: ♦Control of unsuitable units ♦Implementation of computerization ♦Requirements for license supplements ♦Requirements for reporting Errors and Accidents ♦Description of deficiencies noted on inspections ♦Validation of Blood Establishment Computer Software (BECS)

9. 9 FDA’s Findings ♦Significant increases in: ♦number of donor screening questions ♦number of tests performed ♦volume of data to manage ♦reliance on automation and computerized data management ♦errors leading to release of unsuitable blood units

10. 10 FDA’s Follow-on Response ♦Regulation of BECS as a Medical Device ♦March 31, 1994 First Memo to BECS Manufacturers ♦Software Used in Blood Establishments is a medical device

11. 11 FDA’s Follow-on Response (2) ♦Between 1994 and 1996, numerous memos/letters to BECS manufacturers ♦Call and reminders for submission of 510(k)s ♦Jan 13, 1997, Reviewer Guidance for a Premarket Notification Submission for Blood Establishment Computer Software

12. 12 FDA’s Next Steps ♦November 13, 1995 Memo to Blood Establishments ♦Guidance for Blood Establishments Concerning Conversions to FDA-Reviewed Software Products ♦Software conversions should be completed by March 31, 1996 ♦Requests for extensions handled on a case-by-case basis

13. 13 FDA’s Final Response ♦March 20, 1998 BPAC – Classification of BECS ♦Inspectional Findings ♦Device Classification ♦Special Control for Blood Establishment Computer Software to allow submission of Abbreviated 510(k)s ♦Unanimous vote by BPAC to classify BECS as Class II

14. 14 Present/Recent FDA Workshop On Behavior-based Donor Deferrals In The NAT Era, March 8, 2006 ♦Defined QREs as: ♦release of a unit pending the complete verification of donor suitability, including behavioral and medical screening as well as testing. ♦inadvertent release from the quarantine inventory ♦inventory management errors ♦Looked only at blood establishments vs. hospitals ♦Looked only at inadvertent release of a unit that was positive for a viral marker ♦For years 2003, 2004, 2005

15. 15 Present/Recent (2) Publication of “Quantitative estimate of the risks and benefits of possible alternative blood donor deferral strategies for men who have had sex with men” 1Anderson, SA et. al.,; Transfusion, 2009; 49:1102-1114.

16. 16 Summary of Data 1 ♦Some of the data cited in this study was based on BPDR reports for the period October 1, 2003, through Sept 30, 2005. ♦A total of 9 releases of violative units were reported from large blood collection centers and a total of 11 were reported from hospital collection centers. ♦These were taken to be the total releases of violative units in the whole US blood industry.

17. 17 Summary of Data (2) 1 ♦The study also looked at QREs that were estimated from a prospective study of 700,000 donations in the previous decade in New York State ♦The study followed 70,000 units collected in hospitals and 630,000 units collected in blood centers. ♦A total of five releases of violative units came from hospitals and one release of a violative unit came from blood centers.

18. 18 Authors Suggestions 1 ♦There appears to be a need for improved inventory management ♦The implementation of more automation may decrease the number of QREs

19. 19 Future Where do we go from here? ♦This workshop will focus on factors affecting inventory management ♦It is hoped we can identify ♦Some root causes for the residual QREs ♦Ways of mitigating these causes