AATB Standards on Single Donor Aseptic Recovery and Processing of Human Tissue

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AATB Standards onSingle 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 donors ID with
  the donors 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