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# Donor Evaluation

# Donor Evaluation

In  accordance  with  American  Association  of  Tissue  Banks  (AATB)  standards  and  FDA requirements,  JRF  Ortho  and  its  recovery and processing partners utilize extensive evaluation criteria to identify and qualify suitable donors. To ensure the safety of each allograft produced, all recovered tissue is quarantined until donor eligibility has been established. 

### Donor Screening

Donor  eligibility  is  initially  assessed  through  a  comprehensive  screening  process  based  on  requirements  of  the  AATB and FDA.  JRF Ortho utilizes over 75 exclusion criteria to exclude donors with evidence of disease, high-risk behaviors or recent surgical procedures that would affect tissue quality or patient safety. Screening procedures include:

* Verification of informed consent
* Evaluation of complete medical and social history
* Review of date and time of death, and date and duration of refrigeration
* Physical examination

### Serological Evaluation 
During tissue recovery, a blood sample is collected from the donor and tested for infectious diseases by a CLIA certified laboratory. If the donor received an IV or transfusion during his/her hospital stay, a hemodilution calculation is used to verify the accuracy of the serological test results. The donor must test negative or non-reactive for the following: 

* Antibody to Human Immunodeficiency Virus 1 & 2 (anti-HIV 1 & 2) 
* Hepatitis B Surface Antigen (HBsAg)
* Hepatitis B Core IgG/IgM Antibody (HBcAb) 
* Hepatitis B Virus (HBV NAT) (as required)
* Antibody to Hepatitis C (HCV)
* Hepatitis C Virus (HCV NAT)
* Rapid Plasma Reagin or Serologic Test for Syphilis (STS or RPR)
* Human Immunodeficiency Virus Type 1 (HIV – 1 NAT)
*  Additional tests, including but not limited to Human T-cell Lymphotropic Virus Type I & II (HTLV I & II), may have been performed at the time of donor screening, and were found to be acceptable for transplantation.  A list of additional communicable disease test(s) performed will be provided upon request. 

### Recovery Procedures 
Recovery of bone and tissue for JRF Ortho is conducted in accordance with AATB standards and is performed by some of the country’s most reputable organ and tissue recovery agencies. Highly trained procurement technicians follow rigid recovery procedures to ensure high quality tissue. 

* Assessment of physical evidence of possible high-risk conditions 
* Adherence to and documentation of AATB-recommended procurement time constraints 
* Use of aseptic techniques such as surgical skin prep and sterile instrumentation 

### Microbiological Testing 
Donated bone and tissue are cultured either at the time of recovery or during processing. Swab cultures are obtained from each tissue prior to exposure of the tissue to antibiotics, disinfectants or cleansing agents. Cultures are incubated in two types of media at two temperatures for a minimum of 7 days. Further destructive and fluid extraction cultures may be taken and incubated for up to 14 days.  If any of the cultures demonstrate microbial growth, the tissue is the tissue is sterilized or not released for transplant. Any aerobic or anaerobic bacteria detected are identified to the Genus level. 

### Medical Records Review 
Donor information, serological test results and microbiological test results are reviewed and approved by several specialists and medical professionals before tissue is released for surgical transplantation. The JRF Ortho medical records review team includes: 

* Recovery Agency Medical Director
* Medical Records Specialist
* Microbiology/Quality Assurance Laboratory Manager
* AlloSource or Solvita Medical Director