Attachment2.pdf

Salient Characteristics for Fresh Cadaver Parts for Combat Extremity Surgery Courses Proposed

(a) Must Be federal-approved 501(C)(3)

(b) Vendor must be responsible to follow all FDA guidelines in the use of these tissues

(c) Vendor must be Licensed in the United States

(d) Vendor must be capable of shipping Tissue fresh, frozen or snap frozen

(e) Cadavers must be at least from the Hemi pelvis to toe

(f) Arm Specimen must be from shoulder to finger tips full calvicle and scapula

(g) Serological testing for infectious diseases must be performed by CLIA-certified laboratories on all donor tissues prior to placement.

h) Must include the standard screening of (HIV 1, HIV 2, Hepatitis B and Hepatitis C)

(i) Vendor must Cremate Returned Specimens per LB

(j) Vendor must have Kits for Returning Specimens for shipping within Blue Bags 2.80" 6mil, strapping, labels and zip ties

(k) Tissue must be AATB Accredited Tissue

(l) Vendor must have MD Pathologist & Anatomical Case Investigation and review Prior to Tissue Release

(m) Must provide Gel Pack/Ice Pack

(n) Must provide IATA Compliant Air Tray with Box

Notes:

Solicited: Company: ___________________________