Diane Wilson, RN Community Tissue Services 07/16/96 AATB Standards on “Single Donor Aseptic Recovery and Processing of Human Tissue”                                                                                                                                                       Diane Wilson, RN Community Tissue Services

Single Donor Tissue Procurement

Donor Screening Evaluation of hospital records Consent from next of kin Medical social history Serologic/infectious disease screening HIV 1/2, HTLV I/II, HBsAg, HCV, RPR, HBc, and HIV DNA by PCR or HIV Antigen. Physical exam Physician letter (CTS) Blood donor registry (CTS) Medical Director review

Informed Consent: (AATB D2.400) No coercion applied Accurate and not misleading Understandable terms Infectious disease testing Access to medical records Profit vs non profit Cosmetic use Use abroad General purpose of use (transplant, research or medical education) Right to ask questions

Donor Identification: (D5.100 and D5.200) Each donor shall be assigned a unique ID number for tracing of tissues from donor to final disposition. Prior to retrieval, at least one retrieval staff member shall verify the potential donor’s ID with the donor’s name as stated on the informed consent. Donor identity, source and staff member shall be documented in the retrieval record.

Time Constraints: (D5.400) Refrigerated: Donor placed in cooler within 12 hours 24 hours to procure Non-Refrigerated: Donor not placed in a cooler within 12 hours 15 hours to procure

Retrieval Environment (D5.500) Aseptic or clean fashion Using standard surgical prep Sterile packs Instrumentation Technique General site documented and restricted Working surfaces (before and after retrieval) Scrubbed using a bactericidal/antimicrobial agent

Preparation: (D5.510) Cleansing, preparing, and draping the skin as well as technician gowning and gloving shall be accomplished with the same diligence as used routinely for operative procedures. Aseptic technique shall be followed (American Association of Operating Room Nurses - AORN standards)

Surgical Staff Shall: (D5.520) Perform surgical scrub of their hands and forearms prior to retrieval Head cover, eye shields and mask shall be worn at time of scrub Sterile gown and gloves shall be donned after scrub All tissue recovered using aseptic technique

Pre Processing Cultures: (K2.210) Each individually recovered or packaged tissue shall have a pre-processing culture prior to antibiotic, disinfectants, or sterilizing agents Results maintained in donor records MD shall review before release of tissue

Post Retrieval Packaging: (D5.700) Immediately following retrieval or processing at the retrieval site, tissue obtained shall be individually and aseptically wrapped or enclosed and the receptacle will be immediately labeled with donor ID and type of tissue enclosed

Transportation of tissue: (D5.800) Packaged in a manner to permit required environmental conditions to be maintained during transport Containers do not require monitoring if transport containers have been validated Maximum time on wet ice is 72 hours prior to freezing or processing

Transportation of tissue: (D5.800) Transport receptacle label must contain: Human tissue enclosed Name and address of retrieval agency and processing center (if different) “Quarantine: Not Suitable for Transplant in its Current Form”

Reconstruction: (5.900) Dowel rods PVC piping Closure Techniques baseball stitches running stitches

Single Donor Tissue Processing

Processing Methods: (E1.030) Tissue shall be processed by methods known to be validated to prevent contamination and cross-contamination AORN draping Validated cleaning of work surfaces Work surfaces (before and after processing) Scrubbed using a bactericidal/antimicrobial agent

Central Sterile Supply

Reagents and Supplies: (E1.300) Reagents used in processing and preservation shall be of appropriate grade for the intended use and sterile (if indicated) On receipt, record all reagents and supplies including: Type Manufacturer Lot number Date of receipt Expiration date Inspection

Tissue ID Numbers: (E1.100) Each tissue shall be assigned a tissue ID number which shall link the tissue to the donor Tissue units shall be assigned the same tissue ID number only if they are identical and processed as a “lot”

Pooling: (E1.200 and E1.210) Tissue from multiple donors shall not be pooled during retrieval, processing, preservation, or storage. Cross-Contamination: Written procedures shall be prepared, validated, and followed for prevention of infectious disease contamination or cross-contamination by tissue during processing

07/16/96 Cancellous Block

Centrifuge Cup

Ultrasound Bath

Patella Ligament

Femur Grafts

Cortical Struts

Tri Cortical Block

Fibula Segments and Rings

Crushed Cancellous

Final Tissue Culturing (E1.000) Terminal Sterilization by Irradiation or Ethylene Oxide 10% destructive sterility testing, or Equally validated procedure such as 100% swab testing No terminal sterilization 100% swab testing

Tissue Release (F1.000) Quality Control reviews the following before release of tissue to distribution Procurement and Processing Records Medical Director approval Serologies Culture Results Water Residuals (Freeze Dried) Irradiation Dosage

Tissue Receipt Records (L4.200) Transplanted tissue records shall include: Name and address of tissue bank Type, quantity, unique ID # Recipients name,Hospital record #, or SS # Transplantation site, date and time Ordering physician Dispensing person Tissue preparation person, if applicable

07/16/96 Thank You Thank you for your time.