Compliance & safety

Accredited by the American Association of Tissue Banks

Science Care is the first donate-your-body-to-science program accredited by the American Association of Tissue Banks (AATB), which sets the ethical standards in non-transplant tissue banking.

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Science Care is the first AATB accredited non-transplant tissue bank, and very few meet this criteria. The American Association of Tissue Banks which is referred to as the AATB has strict guidelines to promote quality and safety standards necessary to perform non-transplant donations. Through our robust quality system here at Science Care we have several critical control points. We adhere to standards to ensure full traceability from the time the donor enters into our care through final disposition. Here at Science Care, we have both internal and external audits performed several times a year to ensure quality and safety standards are being met. Our strict and consistent commitment to quality and safety standards is a reflection of why Science Care is the first accredited AATB non transplant tissue bank. It is our commitment to continue to be the leaders in this industry with our adherence to quality standards.

What does it mean to be accredited?

• To earn accreditation, Science Care went through an intensive screening process and continues to undergo regular audits.
• Accreditation is obtained for retrieval, processing, storage, and/or distribution of non-transplant anatomical specimens.
• An independent third-party review of all standard operating procedures (SOPs), as well as an on-site full inspection of all facilities and operations is required.
• AATB inspectors perform thorough audits for compliance in all areas of the AATB Standards and Policies, including, but not limited to: recordkeeping, quality control, quality assurance, donor screening, and testing and suitability screening

Serology testing

Science Care always uses CLIA certified laboratories for donor serology screening. The objective of the CLIA program is to ensure quality laboratory screening.

Detection of infectious viruses is very important to tissue bank programs. The ability to identify and exclude donors with these infections protects all individuals who may come in contact with the donated tissue. The earlier in the course of illness detection occurs, the safer it is for all concerned.

Science Care has always been a leader in our industry in support of our mission “...to ensure the utmost safety for our clients and respect for our donors”. We continue to provide cutting edge concepts to fulfill that mission. And so it is with serology testing for the more serious viral infections - Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV). At Science Care, we utilize NAT testing in screening our donors for potential disease. NAT techniques identify viral particles rather than antibodies produces against such viruses, thus shortening the exposed window.

The period of time of infection to detection is referred to as the “window.” The shorter the window, the better it is for all. Nucleic Acid Sequence testing (NAT) has improved the detection time for the major viruses of concern, HBV, HCV and HIV. The “window,” rather than taking months to detect, now measures in days, a marked improvement.

We at Science Care utilize NAT testing in screening our donors for potential disease. These NAT techniques identify viral particles rather than antibodies produced against such viruses thus shortening the exposed window.

In addition to serologic testing, we continue to assess a medical social history and recommend without exception the use of personal protection equipment (PPE) whenever handling anatomical specimens.

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For more information:

• Nucleic Acid Testing (NAT), Food and Drug Administration, Department of Health and Human Services, www.fda.gov/cber/guidelines.htm‍
• History and Future of Nucleic Acid Amplification Technology Blood Donor Testing; WK Roth Transfusion Medicine Hemotherapy 2019; 46: 67-75 (www.karger.com)
• Center for Disease Control: www.cdc.gov
  

Tagging & traceability requirements

To enhance complete traceability, all anatomical specimens recovered are tagged with corresponding donor ID tags, wrapped and labeled. The tags are required to remain with the specimens at all times, up and through final disposition.

Safe handling and return of anatomical specimens & tissue when ordering from Science Care

Safe handling and return of anatomical specimens is critical. At the time of each specimen request, you will be required to provide the details on the place of final disposition for all specimens. Whether you choose to return your specimens to Science Care, or coordinate a local option, the packaging and process remain the same. Please reference our Tissue Return Checklist.