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AATB Standards on“Single Donor Aseptic Recovery
and Processing of Human Tissue”
Diane Wilson, RN
Community Tissue Services
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Single Donor Tissue Procurement
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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
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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
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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.
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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
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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
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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)
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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
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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
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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
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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
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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”
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Reconstruction: (5.900)
Dowel rods PVC piping Closure Techniques
– baseball stitches– running stitches
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Single Donor Tissue Processing
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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
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Central Sterile Supply
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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
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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”
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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
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Cancellous Block
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Centrifuge Cup
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Ultrasound Bath
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Patella Ligament
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Femur Grafts
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Cortical Struts
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Tri Cortical Block
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Fibula Segments and Rings
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Crushed Cancellous
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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
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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
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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
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Thank You