Company: Central Texas Regional Blood and Tissue Center
Product: Blood products
Date: 11/7/03
Specifically, one donor tested Nucleic Acid Test (NAT) HIV positive on a unit donated 4/4/2002. The donor donated a Whole Blood unit on 4/16/2002. The testing laboratory requested the Fresh Frozen Plasma (FFP) to be tested from the 4/16/2002 donation and all tests were negative including the NAT HIV. The donor was deferred for 6 months until 10/2002 and returned for re-testing for HIV at that time. The laboratory sample drawn 10/2002 was non-reactive for Anti-HIV1/2, HIV antigen, NAT HIV, and NAT HCV. The donor was re-entered and listed as eligible to donate 11/2002. Products donated since re-entry are one Whole Blood and seven apheresis units. Five apheresis units were distributed. At this time, FDA has no re-entry algorithm for donors having tested positive by NAT for HIV. This donor was not permanently deferred in your firm …computer system.
One donor had a reactive EIA test for HIV-1 on 10/4/1991 and tested Western Blot (VVB) negative 10/11/1991. The donor was not deferred in the old _____ or current …computer systems and continued to donate 8 units of blood under your firm’s “Silent Re-entry Program.” These units were not distributed. During a donor merge, it was discovered that this donor should be permanently deferred, and the donor was deferred on 7/29/2002. Another donor had a reactive EIA test for HIV 1/2 on 4/28/1994 and WB Indeterminate on 5/9/1994. This donor was accepted for donation on 5/7/1998. The components for this unit were destroyed and the donor has not donated since. This donor was not permanently deferred in the computer system.
Two donors had a reactive test for HCV. One donor was permanently deferred in the previous …computer system but the donor later registered under another name and was not deferred in the current…system. The donor was accepted and donated 11/1999 and 12/2001. Components from 11/1999 were distributed and one of the components was transfused. The error was discovered and the donor was deferred 1/2003. The second donor tested reactive for HCV on a single antigen, unlicensed test in May, 1990 and was permanently deferred. After additional testing was done on a sample drawn in July, 1990 and was negative, the donor was listed as eligible to donate. When further guidance was issued by FDA in 1991 regarding donors that had tested positive for HCV, the donor was permanently deferred. This donor returned in November 2002 and a sample of blood was drawn and tested for HCV 3.0 EIA for re-entry. The donor was non-reactive by this test but no RIBA 3.0 supplemental testing was performed on the sample as required and the donor was re-entered in December 2002 by the Donor Counselor. This donor has donated three units of blood on 2/2003, 6/2003, and 8/2003. This donor was not permanently deferred in the …system.
Two donors tested reactive for Anti-HBc. Although the donations by these donors were for autologous units, neither donor was permanently deferred in the …computer system to prevent subsequent allogeneic donations.
Specifically, one donor tested NAT HIV positive on a unit donated 4/4/2002. The donor donated a Whole Blood unit on 4/16/2002. The testing laboratory requested the FFP to be tested from the 4/16/2002 donation and all tests were negative including the NAT HIV. The donor was deferred for 6 months until 10/2002 and returned for re-testing for HIV at that time. The laboratory sample drawn 10/2002 was non-reactive for Anti-HIV 1/2, HIV antigen, NAT HIV, and NAT HCV. The donor was re-entered and listed as eligible to donate 11/2002. Products donated since re-entry are one Whole Blood and seven apheresis units. Five apheresis units were distributed. At this time, FDA has no re-entry algorithm for donors having tested positive by NAT for HIV. This donor was not permanently deferred in your firm’s…computer system.
Laptop computers that are used for registration of donors on a mobile blood drive are downloaded with the donor deferral list from the …computer system. The laptop computers search for “last name” only and the donor last name is variable. The laptop computer does not cross reference any additional information for duplicate donors such as date of birth or social security number. The investigators found ten QlRs that were initiated for deferred donors who were accepted for donation on mobile drives.
Items f,g,h: The response is inadequate to address the noted observations. You state under the system corrective action that the…computer system automatically defers all donors when reactive screening infectious disease testing results is received. These donors had positive screening infectious disease tests and had not been entered into the previous …system as permanent deferrals so when they were transferred to the current …system, they were not permanently deferred. Two of the donors gave autologous units. Other donors may still not be deferred in the new…system. In addition, how is your firm going to implement controls so deferred donors can donate autologous units and still ensure that these donors will remain deferred? These controls would also apply to donors who would be permanently deferred for other reasons other than reactive screening infectious disease tests.
Item 17: We have determined that the response is inadequate to address the noted observation. In your response you give the background stating that the …computer system keeps an internal audit trail when a permanent deferral is removed by a person and if the deferral is temporary, the…computer system removes the deferral automatically when the deferral time has past. In addition, you state the…SOP does not deal with removing deferrals so does not document a requirement for identifying the person removing the deferral. Your system corrective action states that no internal audit trail is necessary for automatic removal of a temporary deferral by the…system because the identification of the person who performs the succeeding registration that causes the deferral to be removed is recorded on the Donor Record. However, during the FDA inspection, you were unable to produce documentation to identify the person who removed the permanent deferral that is not automatically removed by the…system. You did not address this in your system corrective action part of the response.
FDA District: Dallas District Office
