Mountain View Blood Bank

Mountain View Blood Bank 10/5/99

The _____ Procedure, Revision Date 10-26-94, required donors who test repeatedly reactive for HTLV- 1/2, HIV, HBsAg and HCV to be permanent y deferred and the donors notified. Employees lacked adequate training because they were not following this procedure [21 CFR 606.20(b)]. The donor deferral files were not adequate to identify unsuitable donors so that products from such individuals would not be distributed [21 606. 160(e)]. For example:

Donor _____ (unit #_____) tested repeatedly reactive for HIV-1 antigen (P24) in September 1998. A computer donor inquiry for the donor of Unit # _____ had the donor as “ACTIVE,” but the donor was listed on the Permanent Donor Deferral File. Subsequently this donor donated Unit; W XX on 1/26/99 and the red blood cell component was distributed on or about 1/30/99.
Donors _____ (unit # _____), _____ (unit #_____), _____ (unit #_____), _____ (unit ____) and (unit _____) tested repeatedly reactive for anti-HIV 1/2, but western blot negative in December 1998, May 1999, March 1999, March 1999, and November 1998, respectively. A computer donor inquiry listed these donors as “ACTIVE” (except the status of donor _____ was not determined) and the donors were not listed on the Permanent Donor Deferral File. No record(s) demonstrated that the donors were tested in accordance with an acceptable re-entry protocol.

Donors _____ (unit _____) and _____ (unit _____) tested repeatedly reactive for HBsAg, but confirmatory negative or indeterminate for HBsAg in March 1999 and November 1998, respectively. A computer donor inquiry listed these donors as “ACTIVE” and the donors were not listed on the Permanent Donor Deferral File. No record(s) demonstrated that the donors were tested in accordance with an acceptable re-entry protocol.

Donors _____ (unit , _____) and _____. (unit _____) tested repeatedly reactive for anti-HTLV-1/2, but confirmatory negative in December 1998 and May 1998, respectively. A computer donor inquiry listed these donors as “ACTIVE” and the donors were not listed on the Permanent Donor Deferral File. No record(s) demonstrated that the donors were tested in accordance with an acceptable re-entry protocol.

Donors _____ (unit _____) and _____ (unit _____) tested repeatedly reactive for HCV, but RIBA negative in November 1998. A computer donor inquiry listed these donors as “ACTIVE” and the donors were not listed on the Permanent Donor Deferral File. No record(s) demonstrated that the donors were tested in accordance with an acceptable re-entry protocol.

Donors _____ (unit _____) tested repeatedly reactive for anti-HCV in March 1999 and _____ (unit _____) tested repeatedly reactive for HTLV-1 in May 1998. A computer donor inquiry listed these donors as “PERM DEF,” but the donors were not listed on the Permanent Donor Deferral File.

Donors who tested repeatedly reactive, whose status remained “ACTIVE,” as indicated in “a” through “f’ above, were not notified.
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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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