JRF Ortho Precut Fresh OCA Core Consent Form

The Fresh OCA Cores were procured from a human donor within the last thirty-five (35) days. The donor’s available medical records and medical/social history have been reviewed and acceptability has been established. If an autopsy was performed, the final autopsy results may be pending. Should any pending autopsy results or other information associated with the donor, such as hospital medical records, become available and indicate the donor is unsuitable, you will be notified immediately. It is the responsibility of the physician to ensure that the patient is aware of, and consents to, the risk of Fresh Allograft transplantation.

The following required testing was performed and found to be negative or non-reactive. Serological testing is performed by a CLIA-certified laboratory using tests approved by the FDA where applicable:

  • Antibody to Human Immunodeficiency Virus 1 & 2 (HIV 1 & 2)
  • Human Immunodeficiency Virus Type 1 (HIV-1 NAT)
  • Antibody to Hepatitis C (HCV)
  • Hepatitis C Virus (HCV NAT)
  • Hepatitis B Core IgG/IgM Antibody (HBcAb)
  • Hepatitis B Surface Antigen (HBsAg)
  • Hepatitis B Virus (HBV NAT) (as required)
  • Rapid Plasma Reagin or Serologic Test for Syphilis (STS or RPR)

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.

Although Fresh OCA Cores are not sterile, they are processed and packaged aseptically. Upon release of Fresh OCA Cores for implantation, multiple final microbial cultures of the graft will have demonstrated [revealed] no microbial growth.

In order to have access to Fresh OCA Cores, JRF requires that (i) I acknowledge that the Fresh OCA Cores are processed aseptically and are not sterile, (ii) I agree I will notify my patient (or his/her legally authorized representative) of the risks associated with the Fresh OCA Cores prior to implanting them into my patient, and (iii) I obtain informed consent from my patient for implantation of the Fresh OCA Cores and document that informed consent in their medical record.