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Safety

All donor recovery agencies engaged by Lattice Biologics comply with applicable local, state, and federal laws, regulations, and standards. A potential donor is thoroughly evaluated by both the recovery agency and Lattice Biologics. A preliminary screening and evaluation process is completed by the recovery agency prior to tissue recovery. Such screening includes a medical and social history interview as well as a physical assessment. An extensive review of all relevant medical records is conducted by the Lattice Biologics Quality Systems Department to ensure suitability for processing and distribution of donated tissue.

All donors and donor tissue processed at Lattice Biologics have been subjected to biological and medical screening to guard against the possibility of recipient exposure to, or transmission of, communicable diseases or exclusionary medical conditions.

These screening procedures are performed in accordance with standards, regulations, statutes and/or directives of the American Association of Tissue Banks (AATB), the U.S. Food and Drug Administration (FDA), State Licensing Agencies, the European Union, and Health Canada. Additional communicable disease testing and screening in excess of the requirements by the AATB and FDA may have also been completed. Such data has been reviewed by the Medical Director (licensed physician) of Lattice Biologics and the allografts have been deemed suitable for transplantation.

Communicable disease testing on a qualified donor blood sample is performed by a laboratory registered with FDA to perform donor testing and certified to perform such testing on human specimens in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and 42 CFR Part 493, or that has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS). All required communicable disease tests listed below must be found nonreactive or negative:

HUMAN IMMUNODEFICIENCY VIRUS (HIV)
HIV-1/2 Antibodies HIV – 1/2 – Ab
Nucleic Acid Test for HIV-1 RNA HIV – 1 NAT

Hepatitis B Virus (HBV)
HBV Surface Antigen HBsAg
HBV Core Antibody (IgG & IgM) HBcAb
Nucleic Acid Test for HBV DNA (if applicable) HBV NAT

HEPATITIS C VIRUS (HCV)
HCV Antibody HCVAb
Nucleic Acid Test for HCV-RNA HCV NAT

SYPHILIS
Rapid Plasma Reagin Screen RPR*
T. Pallidum IgG T. pallidum IgG
HTLV-I/II Antibody HTLV-I/II-Ab
Cytomegalovirus CMV Ab (IgG & IgM)
Epstein Barr Virus EBV Ab (IgG & IgM)
Toxoplasma gondii Toxoplasma Ab (IgG & IgM)
Trypanosama cruzi T. cruzi Ab (IgG & IgM)

 

*

Tissues from a donor whose blood specimen is unsuitable
 for the non-treponemal screening assay, such as the RPR test, or with a reactive result from the non-treponemal screening assay, are cleared for transplantation use only when the result from the treponemal-specific (confirmatory) assay is nonreactive.

Non-required screening tests for exposure to other viruses or parasites such as those listed below for may have been performed on the donor by other agencies involved in the donation process. A negative/nonreactive result is not required for these tests; however, all donors are evaluated on a case-by-case basis by the Medical Director.