2011-18093. Quarantine Release Errors in Blood Establishments; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Quarantine Release Errors in Blood Establishments.” The purpose of this public workshop is to provide a forum for discussion of quarantine release errors (QREs) and provide FDA and industry with information necessary to reduce the rates of QREs. The workshop will focus on the extent and characteristics of QREs in blood establishments and the specifications of blood establishment computer software (BECS) as they relate to inventory control. The public workshop has been planned in partnership with the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Health, America's Blood Centers, and AABB. This public workshop will include presentations and panel discussions by experts knowledgeable in this field from government Agencies and industry.

Date and Time: The public workshop will be held on September 13, 2011, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Universities at Shady Grove Conference Center, 9630 Gudelsky Dr., Rockville, MD 20850-5820, 301-738-6000.

Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: [phone], e-mail: [e-mail].

Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone, and fax numbers) to Rhonda Dawson (see Contact Person) by September 1, 2011. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 7:30 a.m.

If you need special accommodations due to a disability, please contact Rhonda Dawson (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

QREs refer to 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. Although QREs that result in the distribution of blood or blood components are required to be reported to FDA as biologic product deviation reports (BPDRs), the amount of information provided in BPDRs varies and often represents a summary of information rather than a detailed description and analysis of the problem. Thus, the root causes of QREs are not known with certainty. Further, the rates of QREs are also not known with certainty, and actions necessary to correct and prevent them are unclear.

There has been a recent focus on QREs related to the release of units with incomplete or absent testing for transfusion-transmitted infectious diseases. On June 10 and 11, 2010, the HHS Advisory Committee on Blood Safety and Availability (the Committee) met to discuss the current FDA blood donor deferral policy on men who have sex with other men. While the Committee recommended that the current deferral policy not be changed at the present time, it found the current policy to be suboptimal in permitting some potentially high risk donations while preventing some low risk donations. The Committee made a number of recommendations and indicated that HHS should take action to investigate and reduce the risk of QREs in blood collection establishments.

This public workshop will serve as a forum for discussion of QREs and provide FDA and industry with information necessary to reduce the rates of QREs. The public workshop presentations and panel discussions will: (1) Review recent BPDR data to better determine the root causes for QREs and identify activities that could address those causes; (2) evaluate the use of 510(k) cleared BECS or implementation of BECS performance standards in reducing the rate of QREs; and (3) explore other potential strategies to address QREs. The public workshop will conclude with a summary of the issues discussed.

Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible on the Internet at: http://www.fda.gov/​BiologicsBloodVaccines/​NewsEvents/​WorkshopsMeetingsConferences/​TranscriptsMinutes/​default.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857.

Dated: July 13, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.