1. 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

2. Single Donor Tissue Procurement

3. 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

4. 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

5. 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.

6. 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

7. 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

8. 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)

9. 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

24. 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

25. 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

29. 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

30. 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”

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

34. Single Donor Tissue Processing

35. 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

37. Central Sterile Supply

38. 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

39. 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”

40. 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

43. 07/16/96
Cancellous Block

44. Centrifuge Cup

46. Ultrasound Bath

47. Patella Ligament

48. Femur Grafts

49. Cortical Struts

50. Tri Cortical Block

51. Fibula Segments and Rings

52. Crushed Cancellous

53. 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

54. 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

55. 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

58. 07/16/96
Thank You
Thank you for your time.