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Tissue Donation
 
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The Blood and Tissue Center of Central Texas (BTC) procures approximately 300 donors each year. This number is steadily increasing as BTC increases partnerships with other tissue recovery programs. The Blood and Tissue Center of Central Texas main facility is located in Austin, Texas with satellite offices in Corpus Christi, TX and another facility in Austin, TX. BTC provided hospitals and other healthcare facilities with approximately 11,000 grafts in 2003. BTC is one of the few Tissue Centers that has the capacity to procure, process, and distribute tissue. All donors procured for and by BTC are processed at the main campus located in Austin.

Tissue Center Affiliations and Regulations

Ensuring our customers a safe and quality tissue graft is the cornerstone of our business. In order to ensure a safe product, BTC has established and adheres to Standard Operating Procedures. In addition to this BTC has maintained accreditation from the American Association Of Tissue Banks (AATB) since the 1986. The Blood and Tissue center complies with guidelines and regulation of the Food and Drug Administration (FDA), the Occupational Health and Safety Agency, (OSHA), and several other state and local health regulatory agencies. The Spring of 2005 will mark the implementation of Current Good Tissue Practices(cGTP) and BTC will be ready to adhere to those practices once implemented.

Staff

BTC Staff includes Certified Tissue Bank Specialists with extensive tissue banking experience.

BTC Bank Staff includes professional staff with extensive medical device, biotechnology, and pharmaceutical industry experience.

BTC has a Quality Control Department to oversee storage units, testing requirements, water system maintenance, review of documentation, and internal audits.

With our diversified staff BTC is on the cutting edge of technology and well equipped to handle new trends and regulations affecting the tissue banking industry.

The Donation Process

Referral Call

When a death occurs in a hospital, they are required by federal law to report the death to a referral line for donation. In turn, the call is triaged to the donor agencies that are contracted to service that particular hospital with donor services. Referral calls may also originate from a medical examiner, justice of the peace or even a funeral director.

BTC’s highly trained and professional staff operates on an on-call basis 24 hours a day, 7 days a week, 365 days a year. The donor coordinator then does a preliminary screening for medical suitability, based on the information first received from the referral agent.

Screening

Every potential donor must pass a thorough Quality Assurance process. Comprehensive medical and social histories are required for every donor. The potential donor is screened for suitability based on medical history, age and other criteria set forth by our Medical Director. If additional information is needed we will consult with physicians, medical staff and family members to acquire the needed information. We will exclude donors, which may be unsuitable due to transmissible diseases, infections, malignancy, toxic exposure, IV drug abuse, HIV, autoimmune disease and any high-risk behavior. We are very careful about the donors we elect to recover, process and distribute. It is our mission to furnish only the safest high quality tissue for transplant.

Informed Consent

Once a thorough screening of the potential donor has been accomplished and we are confident this is a suitable donor, a highly trained donor coordinator will then contact the legal next-of-kin to discuss the option of donation. The responsibility of the requestor is to provide as much information as necessary for families to make an informed decision without exerting pressure or bias. In all cases the family decides what will or will not be donated. If we determine that the family is not comfortable with their decision to donate, we will not encourage or coerce the donation rather we support the family, their feelings, and make ourselves available to assist them in any way possible.

Consent may be obtained in person or may be obtained and recorded by telephone.

For families who have not discussed donation in advance, this can be a very difficult time. We encourage everyone to learn the facts about donation, make a personal choice and discuss it with their loved ones so their wishes may be carried out. Our hope is that you will share your life and share your decision.

Components of an informed consent include:

  • The proper identification of the agency and person requesting consent.
  • Proper identification of the donor.
  • Proper identification and relationship of the consenting person, including name, address and telephone number.
  • A statement granting permission to have access to the donor’s medical records.
  • A statement that blood samples and/or tissue samples will be collected from the donor for serology testing for certain transmissible diseases and the need to conduct these tests.
  • A statement that all information relating to the donor will be held in strict confidence.
  • A full and specific description of tissues to be recovered in language appropriate for the Next-of-kin.
  • Families who wish to donate for transplantation only, or who wish to exclude research or cosmetic uses should be able to do so.
  • A statement that the costs of the donation and recovery activity will not be the responsibility of the donor.
  • Disclosure of the medical suitability process and the need to protect recipients from disease transmission.
  • A discussion regarding funeral arrangements, and if donation will impact any of these arrangements and/or plans.
  • Any additional information required by state and/or local laws and/or regulations.

    At all times, questions from any family member(s) should be taken seriously and answered fully. If the requestor does not have the proper information, it is their responsibility to insure that the information is made available to the family in a timely manner.

    Recovery Of Tissue

    The standard musculoskeletal recovery consists of the long bones and connective tissue (tendons, ligaments and cartilage) of the lower extremities, the pelvis, and lumbar spine. We have the ability to recover both Saphenous and Femoral veins from the same incision where we have recovered the long bone.

    A thin layer of skin may be removed from non-visible areas front and back.

    Finally, we may remove the non-beating heart for the heart valves. In all cases only tissue that has been consented for by the family will be removed.

    Our policies and procedures require the procurement of tissue be done in an aseptic environment following standards established by the Association of Operating Room Nurses (AORN). Our procurement technicians have gone through extensive training and are current on all of the latest requirements of AATB and FDA.

    The procurement team will replace the recovered tissues with prosthetics to allow for all funeral options, including an open casket. BTC works very closely with funeral homes to ensure that all burial issues are handled appropriately. To insure we understand challenges facing the funeral home staff, BTC has two licensed funeral directors on our staff.

    Type of Allografts used for some surgical procedures

    Acetabular Reconstruction

    Acetabulum
    Cancellous Block
    Cancellous, Crushed
    Femoral Condyles, Hemi or Whole
    Femur Head

    Anterior Cervical Fusion

    Unicortical Cloward Dowels from
         Femoral Condyles
         Femur Greater Trochanter
         Femoral Head
         Tibia, Proximal and Distal

    Tricortical from Ilium
         Crock Dowels
         Iliac Crest Wedge
         Ilium , Hemi/whole
         Matchsticks

    Tricortical from Patella
         Patellar Bone

    Anterior Cervical Disc Fusion

    Corticocancellous Struts from
         Proximal Tibia or Distal Femur
         Fibula, Distal, Proximal or Whole

    Fibula Ring from Fibula Shaft
    Tibial/ Femoral Ring from Tibia/ Femur Shaft

    Anterior/ Posterior Cruciate Ligament Repair

    Achilles Tendon
    Fascia lata, various sizes
    Patella Ligament, from Proximal
    Tibia
    Tibialis Tendon
    Semi Tendinosus/ Gracilis

    Anterior Lumbar Interbody Fusion

    Femur Ring, from Femur Shaft
    Femur Ring with Dowel, from
    Femur Shaft, Dowel areas

    Cardiovascular Transplant

    Heart Valves: Aortic, Pulmonary
    Mitral Valve from Heart
    By-pass: Coronary Artery (Heart) or vascular (Leg) from
    Saphenous Vein, Femoral Vein or
    Femoral Artery

    Cornea Transplant

    Cornea from the eye

    Craniotomy

    Ilium, Bicortical Plates

    Duraplasty

    Dura Mater,Various Sizes
    Fascia Lata,Various Sizes
    Pericarium Various Sizes

    Ear Reconstruction

    Ear Ossicles

    Eye Reconstruction

    Eyelid, and area around the eye
    From Fascia, Pericardium, Skin

    Facial Reconstruction

    Rib, Rib Cartilage,Various Lengths
    Bicortical Strips, from Cranium
    or Ilium
    Mandible

    Fracture Repair (Compound, Comminuted, Impacted)

    Bicortical Strips, from Ilium or
    Cranium
    Cancellous, Crushed or Chipped
    Femur, Proximal and Distal
    Femur Shaft,Various Lengths
    Tibia, Proximal and Distal
    Tibia Shaft

    Hip Revision,Total/ Hip Surgery

    Acetabulum
    Cancellous Blocks
    Cancellous, Cubed or Crushed
    Condyles, Whole or Hemi
    Femur Head
    Femur, Proximal, with or
    without Head
    Acetabulum
    Femur, Distal
    Femur, Proximal, with and
    without Head
    Tibia, Distal

    Humerus Surgery

    Humerus, Proximal, with and
    without Rotator Cuff
    Humerus, Distal
    Humerus, Whole

    Interacranial Aneurysm Repair

    Dura,Various Sizes
    Fascia lata,Various Sizes
    Pericardium, Various sizes

    Knee Surgery

    Femur, Distal
    Rib Cartilage,Various Lengths
    Tibia, Proximal
    Meniscus

    Ligament Replacement/Repair

    Achilles Tendon with Bone Block
    Fascia lata,Various Sizes
    Patellar Ligament, from Proximal
    Tibia
    Tibia, Proximal, with Ligament
    Achilles Tendon
    Fascia lata, various sizes
    Meniscus, from Proximal Tibia
    Patella Ligament, from Proximal
    Tibia
    Tibialis Tendons and Semi Tendinosus or Gracilis

    Mandibular Repair

    Bicortical Strips from
    Ilium or Cranium
    Mandible
    Rib Cartilage

    Meniscus Repair

    Meniscus, from Proximal Tibia

    Nose Reconstruction

    Rib Cartilage

    Open Reduction Internal Fixation

    Cancellous Blocks, from
    Proximal Tibia, Condyles
    Cortical Struts
    Matchsticks

    Periodontal Surgery

    Cancellous, Crushed or Powdered,
    Mineralized or Demineralized
    Cortical Bone Powder

    Shaft Replacement

    Femur Shaft
    Humerus Shaft
    Tibia Shaft
    Fibula Shaft

    Spinal Surgery

    Crock Dowels,Tricortical, from
    Ilium or Patella
    Dowels,Tricortical, from Patella
    Iliac Crest Wedges
    Matchsticks

    Reconstruction Arthrodesis Surgeries

    Cancellous Bone
    Cortical Bone
    Corticoncellous Bone

    New Technology

    BTC continually strives to be pro-active in the tissue industry by taking advantage of the latest available, proven technology. In keeping with those efforts we are currently researching the latest most effective technology such as:

  • Pathogen inactivation
  • Micro-decontamination methods
  • Environmental monitoring procedures
  • Bio-burden studies
  • Validation

    Quality Assurance

    The primary goal of the BTC is to provide a quality health service to the community. To achieve this goal we strive to meet the highest quality and safety standards recommended by medical and scientific communities. As a result, BTC meets or exceeds all standard set forth by the American Association of Tissue Banks and the Food and Drug Administration.

    Quality assurance on all allografts begins well before the tissue is recovered. Tissue bank staff members obtain a very thorough medical and social history screening from the donor’s next-of-kin or the person having the most complete and current knowledge of the potential donor’s medical and social history.

    In addition to the extensive screening process, all donor tissues are tested and blood results MUST test negative for the following:

  • HIV1 and HIV2 antibodies (AIDS screen)
  • Hepatitis B surface antigen
  • Hepatitis B Core
  • Hepatitis C Antibody
  • Human T-Lymphotropic Virus Type I & II
  • Syphilis or RPR
  • NAT HIV1
  • NAT HCV 

     NOTE: As other NAT tests become available, BTC will incorporate them into our procedures for serology testing.

    Quality Assurance is involved in every process regarding tissue, including recovery, and final distribution. There are many layers of checks and balances to insure the final safety of tissue that is processed and distributed by BTC.