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

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

Thank You