Screening & Testing
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Tissue Screening
RTI Biologics screens recovered tissue in numerous ways to guard against transmissible diseases. This screening process includes evaluation of risk on the basis of donor lifestyle, interviews with the donor's family and physical examination of the donor. We also perform biomedical testing at various stages during the conversion of the tissue into implantable tissue, using FDA licensed and other tests for known viruses and pathogens. (See "Quality Assurance & Quality Control")
Quality Assurance & Quality Control
As a tissue processor, RTI Biologics, Inc., (RTI) maintains a Quality Assurance Programs in compliance with the following federal and state regulations* and voluntary standards:
- FDA Current Good Tissue Practices, 21 CFR Part 1271
- FDA Human Tissue Intended for Transplantation, 21 CFR Part 1270
- AATB Standards for Tissue Banking
- State of Florida Statutes
- State of New York Public Health Law
- State of California Health and Safety Code
- State of Maryland Code
RTI is also under the inspection authority of and registered with the Food and Drug Administration.
*These are the only states that require licensure for processing and distributing human tissue.
RTI Biologics’ Biomedical Laboratory is inspected and certified by the following regulatory and certifying agencies:
- CLIA Certificate of Compliance (Federal)
- State of Florida
- State of New York
- ISO 13485 is an internationally recognized standard of quality assurance in product design, development and production. Our biomedical laboratory is certified under the Clinical Laboratory Improvements Act, or CLIA. CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the areas of personnel qualification, administration, participation in proficiency testing, patient test management, quality control, quality assurance and inspections.
Donor Screening
- Behavioral / Lifestyle Risk Assessment
- Family / Next-of-Kin Interview
- Medical Record Evaluation / Hospital Records
- Medical Examiner / Coroner’s Report (autopsy report, when available)
- Laboratory, Pathology and Radiology Reports
Donor Tissue Testing
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AATB |
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