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2. – to consolidate, standardize, and centralize the
handling of human-derived tissue.
– The tissue bank is charged with qualifying
tissue vendors, ensuring proper handling and
storage of tissues, monitoring of temperature,
record keeping, and issuing procedures to
ensure traceability.
What is a tissue bank?
3. – It is not a requirement for hospitals to locate the
tissue bank within the blood bank or require
that a specific tissue bank be established, yet
the blood bank is a natural fit for tissue banking
What is a tissue bank?
4. What is a tissue bank?
– Its basic function is to provide surgeons and
their patients with safe, quality tissue
products while maintaining detailed records
for each tissue handled through final
disposition.
5. When did tissue bank started?
– 1682: first bone transplant
– early 20th century: joints, corneas and skin
– 1949: establishment of first tissue bank
6. What are the common tissues
found in tissue banks?
1. Bones
2. Ligaments
3. Tendons
4. Heart valves
5. Skin
6. Veins
7. Cartilage
8. Dura mater
9. Hematopoietic
progenitor cells
10. Corneas or eye
7. What are the tissues
excluded in tissue banks?
1. Vascularized organs
2. Autologous tissue
3. Blood vessels recovered with organs
4. Minimally manipulated bone marrow
5. Tissue intended for education or nonclinical
research
6. Xenografts
7. Blood components and blood products
8. Secreted or extracted products
8. Who are responsible for the
oversight of a tissue bank?
– Physician-appointed medical director
– Development of a tissue committee
– Quality assurance coordinator or
compliance officer
– Hospital tissue coordinator
9. What is the process of allograft
acquisition and inventory?
– Inspect package integrity, correct labelling and
packing invoice.
– Name and address of tissue supplier, description
of tissue and quantity, date of tissue receipt,
condition of tissue upon receipt, and expiration
date.
– Ensure that transport temperature range has
been controlled and acceptable.
– Detailed and accurate inventory management
10. How tissues are stored in a
tissue bank?
– Storage conditions vary between different
tissues.
– Same tissues can have different
temperature and duration requirements.
– Continuous monitoring
– Alarm system
11. How record keeping and
traceability is achieved?
– Each change in the status of the product
must be documented concurrent with the
action.
– 10 years
– Dispensing records:
– implanted
– discarded
– explanted
12. Are autologous tissues
accepted in a tissue bank?
– Autologous tissue refers to any tissue that is
removed from a patient with the intent to
reimplant it at a later date and during a
different procedure than its removal.
13. Are autologous tissues
accepted in a tissue bank?
– Advantages: perfect immunological match
and diminished risk of infectious disease
transmission
– Disadvantage: possibility of bacterial or
fungus reinfection and reintroduction of
malignant cells
14. Are there any adverse events
after a tissue implant?
1. Transmission of infectious disease – relatively
rare
2. Transmission of malignancy – extremely rare
3. Allograft failure
15. What happens when an
error is discovered?
Recalls are initiated, even if it is months to years
after the tissue has been processed.
1. Class I recall
2. Class II recall
3. Class III recall
16. How tissue bank was introduced
here in the Philippines?
– A 1984 conference at the Lung Center of the
Philippines
– Mr. Frank Dexter of the Yorkshire Tissue Bank,
Professor Glynn Phillips and Dr. Ramen Mukherjee of
the International Atomic Energy Agency.
– "Preparation and Clinical Use of Irradiated Sterilized
Freeze Dried Bone Allografts“ by Dr. Norberto R.
Agcaoili
17. When did tissue bank started
here in the Philippines?
– University of Philippines General Hospital
Tissue Bank, Department of Orthopedic
Surgery, University of Philippines, College of
Medicine
– Dr. Norberto Agcaoili in May 1990
– Philippine Nuclear Research Institute
18. What is the current state of tissue
banking in the Philippines as of today?
– Norberto R. Agcaoili Memorial Tissue Bank
– Cordlife Medical Philippines
– Eye Bank Foundation of the Philippines
– StemCord Philippines
20. SLIDE 3: Because tissue is already handled in this field in liquid form, so many transfusion services have taken
on the additional role of tissue bank.
SLIDE 5: U.S. Navy established the first tissue bank. In its 50 years in existence, it created the first model for tissue
harvest, processing, storage, and transplant. Many of
the principles developed by the U.S. Navy Tissue Bank are standards still followed today.
SLIDE 6: Bone can be sterilized and all living tissue removed. Pieces of bone can be helpful in pinning fractured bone
together, or incorporation of knee or hip replacements into the native bone. Ligaments and Tendons are both helpful in
orthopedic surgeries, especially the replacement of anterior cruciate ligament if there’s an ACL injury. Together with
Cartilage, these are used in repair of facial disfigurements. Heart valves are used in valve replacement procedures for the
heart. These nonmechanical heart valves are more preferred than the mechanical heart valves for the nonmechanical
allows the valve recipient to be nonreliance with anticoagulants, which is a mandatory for the mechanical heart valves.
Skin grafts are used for burn patients, patients with any large loss of skin, such as pressure sores, nonhealing ulcers,
autoimmune disorders, and surgical or traumatic loss of large areas of skin. Veins are intended for patients with coronary
artery bypass grafts and other vessel bypass. Hematopoietic progenitor cells are used to repopulate the bone marrow
which may have been destroyed due to chemotherapy and irradiation. Corneas are used to replace damaged corneas due
to trauma, disease, or birth defect. Eye tissues or sclera are used as a patch for eyes that have been punctured or torn.
The mentioned tissues are useful regardless of the donor’s or patient’s HLA type. No blood type or tissue match is
required.
SLIDE 7: In general, the scope of the tissue bank is limited to nonvascularized tissue. Vascularized organs such as the liver,
kidney, lung, pancreas, and heart are the type of tissues that are immediately transplanted and storage is not necessary
or desirable.
Slide notes!
21. SLIDE 8: AABB requires the medical director to be a medical director who investigates adverse outcomes, participates in
look-back investigations, approves SOP, and communicates with physicians using the end product. Pwedeng same
physician with the blood bank, pwede ding mag-appoint ng separate physician for the tissue bank. Development of a
tissue committee is recommended. Their major goals include peer review, evidence-based clinical indications, and audits
ensuring compliance with SOP. They also review operations, usages trends, shortages, wastages and errors. Quality
assurance coordinator assesses processes, policies and procedures and make recommendations to the medical director
regarding operations. hospital tissue coordinator is the responsible for all the administrative operations – define policies
and procedures, ensure staff training and competency manage acquisition and inventory, and prepares report.
SLIDE 9: The hospital tissue bank serves as the clearing house for all tissues entering the hospital. The tissue bank is
responsible for approving tissue vendors and receiving all specimens. Upon receipt, inspect package integrity, correct
labelling and packing invoice. Tissue receipt must contain the following information: Name and address of tissue supplier,
description of tissue and quantity, date of tissue receipt, condition of tissue upon receipt, and expiration date. Acceptable
temperature range is evidenced by residual dry or wet ice. A detailed and accurate inventory management is cost-saving,
It will reduce wastage of products stored until expiration or will prevent unnecessary orders.
SLIDE 10: Therefore it is fully recommended to follow the instructions from the tissue vendor. Freezers, refrigerators, and
storage units in room temperature must be monitored and maintained. Alarm system ensures the integrity of product
being stored.
SLIDE 11: Receipt of tissue, change in location within the tissue bank, issue, return, transplantation or disposal – all must
be documented with name, time and date. Records are maintained for a minimum of 10 years after the product
expiration. Implanted – tissue was implanted in the patient. Discarded – tissue was discarded in the operation room and
not implanted. Explanted – tissue came into contact with the patient, removed either immediately during surgery or at a
later date
Slide notes!
22. SLIDE 12: So technically, yes. Pero kung ang autologous tissue na na-harvest sa isang hospital ay gagamitin din sa same
institution, there’s no need for the tissue bank to register as a tissue establishment. Pero kung ang na-harvest na
autologous tissue ay gagamitin sa ibang hospital, the hospital tissue bank would be required to register as a tissue
manufacturing establishment.
SLIDE 14: An adverse event is a negative change, unexpected outcome, or reaction to the tissue implant.
1. Transmission of infectious disease – Often, the biggest cause of disease transmission is human error due to inadequate
donor screening, inadequate sterilization and other system failures. Infections are most often transmitted by tissues that
are fresh or cryopreserved. Possibilities for introduction of infection include misdiagnosis of fatal infection of the donor,
during the surgical harvest of the tissue, processing of the tissue and perimortem blood transfusion.
2. Transmission of malignancy – Almost known cases of malignancy transmission have been through organ
transplantation. Two cases of corneal transplant were able to transmit carcinomas, while blood transfusion did not have
any record of malignancy transmission. Bone, tendon and ligament have few viable cells present at transplant and
undergo several sterilization steps, while heart valves and vascular tissue rarely harbor malignancies. Donors are deferred
when malignancies are present at the time of donation.
3. Allograft failure – The allograft may fail to function as expected or intended. In most cases, these are due to the
patient’s underlying condition. Other reason is the changes in the stability and durability of the tissue product due to
failure of the tissue manufacturer to adhere with the SOPs.
SLIDE 15: Recalls are classified into three according to FDA.(1) Class I recall – recalls that are most severe and serious.
Products recalled may cause serious herm, health problems or death. (2) Class II recall – recalls that are intermediate.
Products recalled may cause temporary health problems or less serious injury. (3) Class III recall – recalls that are the
most common. Products recalled are unlikely to cause harm, for errors are only due to either manufacturing irregularity
or violation in labeling.
Slide notes!
23. SLIDE 16: Mr. Frank Dexter is from the Yorkshire Tissue Bank, wherein we adopted the method of procurement,
processing and allograft utilization through the Yorkshire Tissue Bank Manual. Professor Glynn Phillips and Dr. Ramen
Mukherjee are both from the International Atomic Energy Agency wherein we acquired the important equipment for
tissue banking. Thanks to Dr. Norberto R. Agcaoili and his project "Preparation and Clinical Use of Irradiated Sterilized
Freeze Dried Bone Allografts." which allowed us to acquire tissue banking equipment from International Atomic Energy
Agency.
SLIDE 17: All tissues are gamma-irradiate at PNRI in Manila.
SLIDE 18: Norberto R. Agcaoili Memorial Tissue Bank is a unit for the processing of tissue allografts particularly bone. As
the first bone bank in the country, it supplies the allografts for tumor resection, joint replacement and spine surgeries. It
is manned by a dedicated and certified bone bank technician. Cordlife Medical Philippines was officially launched in
February 2010 as Philippines’ first and only umbilical cord blood processing and cryopreservation facility to better serve
the umbilical cord blood banking needs of the local market. It is a DOH-registered, ISO-certified, and AABB-accredited
cord blood banking facility, making it the first and only in the Philippines to have acquired such prestigious status. Eye
Bank Foundation of the Philippines was established on October 16, 1995, and is a non-profit, non-government,
humanitarian organization that owns and operates a medical eye bank named the Santa Lucia International Eye Bank of
Manila (SLIEB). The SLIEB is a state-of-the-art eye banking facility dedicated to the collection, processing, evaluation,
storage and equitable distribution of quality corneal/ eye tissues for transplant, research and education. It is committed
to its mission of bringing the gift of sight to corneally blind individuals through corneal transplants, regardless of age,
gender, race, religion or financial status. StemCord Philippines, Inc. is affiliated with StemCord Pte. Ltd. (Singapore) as the
pioneer in providing cord blood banking services in the country. Since 2002, StemCord has been the pioneer in more
ways than one. As Singapore’s experienced and established private cord blood and cord stem cell bank, we are
committed to the uncompromising standards of processing and preserving your baby’s cord blood and cord stem cells.
Slide notes!