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Steps in the Tissue Donation Process

• A referral is received from a hospital, medical examiner, funeral home, or ossibly law enforcement authorities.

• As a condition of receiving Medicare reimbursements, the Medicare Conditions of Participation (COP) regulations require hospitals to report all deaths to an OPO, tissue bank and/or eye bank.

• 90+ percent of all referrals to AATB-accredited tissue recovery agencies come from hospitals

• A central screening unit, staffed with trained individuals, receives the referral and makes the initial determination of donor eligibility based on certain basic criteria and available information (e.g., age, cause of death, immediate evidence of infection, etc.).

• If the potential donor is ineligible (i.e., determined to be unacceptable), no contact with family members is made, nor is there any search of registries or for a document of gift.

• If the central screening unit determines that the deceased individual could potentially be a donor, a search of available donor registries and for a document of gift may commence. A trained requestor contacts the potential donor’s family to offer an opportunity to donate.

• Consent must be obtained and documented according to AATB Standards for Tissue Banking and the state anatomical gift law. AATB’s standards for consent are extensive, and the AATB has had requirements for consent since the first edition of its Standards in 1984.

• The AATB even requires its accredited tissue banks to provide follow-up services to donor families that might include outcome information, bereavement support, copies of the Document of Consent, guidance on contacting the tissue bank if questions arise, etc.

• A proposal that the AATB strongly supported and lobbied for, the proposed 2006 Revision of the Uniform Anatomical Gift Act contains a new provision making it a crime to forge or falsify a document of gift in order to obtain a financial gain.

• Once consent is given or the authorization is verified, a recovery team is dispatched by the tissue bank responsible for the recovery (the recovery agency).

• The recovery agency:

• Assigns the potential donor a unique identifier so that the tissue can be tracked;

• Confirms the donor’s identity;

• Verifies the consent/authorization and the tissues to be retrieved;

• Reviews available donor information (i.e., relevant medical records);

• Determines whether the recovery site is suitable and will not be a source of contamination;

• Collects a blood sample to be used for infectious disease testing and, if indicated, a suitability evaluation of the sample is performed to determine the potential for plasma dilution;

• In addition to required testing for HIV 1/2, HBV, HCV and syphilis, the AATB requires testing for HTLV-I/II and the use of NAT technology for HIV 1 and HCV.

• Performs a full-body examination of the deceased and documents the physical assessment;

• Confirms critical time limits (i.e., time of death, asystole, or last time seen alive, whichever is earlier); body cooling/refrigeration requirements; ability to recover tissue based on previous two times;

• Retrieves tissues using standard operating procedures (SOPs) and AATB Standards and published guidance documents:

• Aseptic technique is utilized;

• Skin is surgically prepped;

• Retrieval team is gowned and gloved;

• Donor’s body is draped using surgical methods;

• Tissues may be cultured upon recovery, wrapped in a sterile packaging system, labeled, identified as quarantined, and placed in storage, or immediately transported to a processor using appropriate environmental shipping conditions for each tissue type;

• All available relevant medical records are obtained and forwarded to the processors who receive tissues;

• The donor is reconstructed in accordance with the procedures/policies, unless there is a specific request from a medical examiner, pathologist, or funeral home; and

• Donor body is transported to requested destination.

• Donor registries and documents of gifts are sought out and examined.

• Medical history and behavioral risk assessment are obtained from the next of kin, friends, and/or other suitable historian.

• Additional relevant medical records may also be secured for review as indicated (doctor, hospital, autopsy, etc).

• Infectious disease testing results performed on qualified blood specimen(s) are reviewed.

• Testing laboratory must be registered with FDA and must be CLIAcertified (or CMS equivalent) for performing communicable disease testing.

• Test kits used for communicable disease testing must be approved, licensed or cleared by the FDA for use as donor screening tests.

• All the documents, histories, records, culture and test results are reviewed. The eligibility determination is made by the Medical Director of the tissue bank.

• Donor is assigned a unique identifier by the processor (i.e., the processing tissue bank).

• Receipt of tissue is documented (e.g., acceptable temperature, condition of transport container, etc.).

• Depending on the tissue type, it is either stored for processing at a later date or, if applicable, time-sensitive processing begins within established time limits.

• If a recovery culture was not obtained then a pre-processing culture is obtained and submitted to a CLIA-certified laboratory.

• Tissue is processed in appropriate environmental conditions (e.g. Class 100 or cleaner for cardiac and vascular tissue, and bacteriologically and climate controlled for other tissue types).

• Processing is performed by methods validated to prevent contamination and cross-contamination.

• Commingling or pooling tissues from more than one donor is prohibited.

• The physical characteristics of the tissue are evaluated. Processing into specific allograft units/types/ forms is based on clinical need.

• Specimen/graft sizing is performed.

• Tissue is sterilized/disinfected using a variety of methods (e.g., irradiation, disinfection with chemical agents, heat, exposure to antibiotics, etc.). Some processing methods have been validated to greatly reduce or kill bacteria and viruses.

• Tissue is preserved (e.g. control-rate freezing, lyophilization, dehydration, cryopreserved, etc.).

• Appropriate processing time limits are followed, and processing controls are observed and documented.

• Tissue containers are inspected prior to use, and final packaging must be appropriate to the type of tissue.

• Tissue is quarantined until final culturing and/or testing is/are conducted, and the tissue is labeled then released to inventory for subsequent distribution.

• Tissue allografts are labeled.

• If allografts require specific environmental controls (i.e., refrigerated or frozen), then storage temperatures are controlled by monitoring and documented.

• Technical staff performs review of tissue suitability after processing.

• There must be documentation by technical staff that the tissue meets specified technical parameters.

• Quality assurance (QA) and quality control (QC) reviews must be performed prior to release of tissue.

• Final donor suitability review is performed by the Medical Director (i.e., a licensed M.D. in good standing) or a licensed physician designee.

• There must be documentation of each significant step of the process, from donor screening and testing, tissue recovery and processing through final distribution to a consignee or an end user.