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DUKE KASPRISIN, M. D.
JEFF WINSTEAD
The 2011 Joint Commission Tissue
Standards: Key Changes and
Common Survey Findings
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Agenda
• 2011 Joint Commission tissue standards and
key compliance requirements
• Key differences in 2011 tissue standards
• Common survey findings
• Tissue management lifecycle
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• TS.03.01.01: The hospital uses standardized
procedures for managing tissues.
• TS.03.02.01: The hospital traces all tissues bi-
directionally.
• TS.03.03.01: The hospital investigates adverse
events related to tissue use or donor infections.
Joint Commission (JC) Transplant
Safety Standards for Tissue -
January 2011
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JC examples of
tissue products
to include under
standards
• Acellular Dermal Matrix
• Amnion/Amniotic Membrane
• Arteries
• Autologous Cells
• Autologous Tissue
• Bone
• Bone Marrow
• Bone Paste
• Bone Powder
• Bone Putty
• Cancellous Chips
• Cardiac (Heart) Valves (aortic,
pulmonary)
• Cartilage
• Chondrocytes
• Cornea
• Demineralized Bone Matrix
• Dendritic Cells
• Dermis
• Dura Mater
• Embryo
• Fascia/Fascia Lata
• Hematopoietic Stem Cell
• Leukocytes
• Ligaments
• Limbal Graft
• Limbal Stem Cells
• Lymphocytes
• Marrow
• Membrane
• Meniscus


• Nerves
• Non-valved Conduits
• Oocyte/Ovarian Cells
• Ovarian Tissue
• Pancreatic Islet Cells
• Parathyroid
• Pericardium
• Peripheral Blood Stem Cells
• Progenitor Cells
• Sclera
• Semen, Sperm
• Skin
• Somatic Cells
• Tendons
• Testicular Tissue
• Therapeutic Cells (T-Cell
Pheresis)/T-Cells
• Tissue (also Synthetic Tissue)
• Trachea
• Umbilical Cord Blood Stem Cells
• Vascular Graft
• Veins (Saphenous, Femoral, Iliac)
• Other cellular- and tissue-based
transplant or implant products
whether classified by the U.S. Food
and Drug Administration as a tissue
or a medical device.
• Other tissues that are classified
as tissues by state law and
regulation.

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Joint Commission (JC) Transplant
Safety Standards for Tissue -
January 2011
TS.03.01.01
The hospital uses standardize procedures
for managing tissue.
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TS.03.01.01 – Requirements (EPs)
• The hospital assigns responsibility to one or more individuals for
overseeing the acquisition, receipt, storage, and issuance of tissues
throughout the hospital.
• The hospital develops and maintains standardized written procedures for
the acquisition, receipt, storage, and issuance of tissues.
• The hospital confirms that tissue suppliers are registered with the U.S.
Food and Drug Administration (FDA) as a tissue establishment and maintain
a state license when required.
• The hospital coordinates its acquisition, receipt, storage and issuance of
tissues throughout the hospital.
• The hospital follows the tissue suppliers’ or manufacturers’ written
directions for transporting, handling, storing and using tissue.
• The hospital documents the receipt of all tissues.
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• The hospital verifies at the time of receipt that package integrity is met and
transport temperature range was controlled and acceptable for tissues
requiring a controlled environment.
• The hospital maintains daily records to demonstrate that tissues requiring a
controlled environment are stored at the required temperatures.
• The hospital continuously monitors the temperature of refrigerators,
freezers, liquid nitrogen tanks and other storage equipment used to store
tissues.
• Refrigerators, freezers, liquid nitrogen tanks and other storage equipment
used to store tissues at a controlled temperature have functional alarms and
an emergency back-up plan.
• The hospital complies with state and/or federal regulations when it acts as
a tissue supplier.

TS.03.01.01 – Requirements (EPs)
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• Verify at receipt that package integrity is met and
transport temperature range was controlled and
acceptable.
– “Tissues requiring no greater control than ambient
temperature for transport and storage would not need
to have the temperature verified upon receipt.”
– “If the distributor uses validated shipping containers,
then the receiver may document that the shipping
container was received undamaged and within the
stated time frame.”
TS.03.01.01– Key Changes
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• The hospital maintains daily records to demonstrate
that tissues requiring a controlled environment are
stored at the required temperatures.
– “Tissues requiring no greater control that ambient
temperature for storage would not require temperature
monitoring.”
• The hospital continuously monitors the temperature of
refrigerators, freezers, liquid nitrogen tanks and other
storage equipment used to store tissues.
– “For tissue stored at room temperature, continuous
temperature monitoring is not required.”

TS.03.01.01 - Key Changes
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Common Survey Findings
• The hospital develops and maintains standardized
written procedures for the acquisition, receipt,
storage, and issuance of tissues.
− Inadequate SOPs
− SOPs not being followed or not fully
understood (training issue)
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Common Survey Findings
• The hospital coordinates its acquisition, receipt,
storage and issuance of tissues throughout the
hospital.
• The hospital documents the receipt of all tissues.
− JC surveyors are drilling down to determine
exactly where tissue enters the facility (logistics,
Blood Bank, OR) and the process of
documentation at that point of entry
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Joint Commission (JC) Transplant
Safety Standards for Tissue -
January 2011
TS.03.02.01
The hospital traces all tissues
bi-directionally.
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TS.03.02.01 - EPs
• The hospital’s records allow any tissue to be traced from the donor or tissue
supplier to the recipient (s) or other final disposition, and from the recipient
(s) or other final disposition back to the donor or tissue supplier.
• The hospital identifies, in writing, the materials and related instructions
used to prepare or process tissues.
• The hospital documents the dates, times, and staff involved when tissue is
accepted, prepared, and issued.
• The hospital documents in the recipient’s medical record the tissue type
and its unique identifier.
• The hospital retains tissue records on storage temperatures, outdated
procedures, manuals, and publications for a minimum of 10 years. If
required by state and/or federal laws, hospitals may have to retain tissue
records longer than 10 years.
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TS.03.02.01 - EPs

• The hospital retains tissue records for a minimum of 10 years on all of the
following: tissue supplier, original numeric or alphanumeric donor and lot
identification, name (s) of the recipient (s) or the final disposition of each
tissue, and expiration dates of all tissues.
• The hospital completes and returns tissue usage information cards
requested by the tissue supplier.
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Tracking vs. Tracing
• Tracking: To follow a process or product from
beginning to end
• Tracing: To follow the history of a process,
product, or service by review of documents

International Standards For Cellular Therapy
Product Collection, Processing, And Administration
– 3
rd
Edition
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• The hospital identifies, in writing, the materials
and related instructions used to prepare or
process tissue.
– Are the lot numbers and expiration dates of the
reconstitution products being tracked at your
facility?
• The hospital documents the dates, times, and
staff involved when tissue is accepted,
prepared, and issued.
TS.03.02.01 – Common Findings
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Joint Commission (JC) Transplant
Safety Standards for Tissue -
January 2011
TS.03.03.01
The hospital investigates adverse events
related to tissue use or donor infections.
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Highlights of TS.03.03.01
• The hospital has a written procedure to investigate tissue adverse events,
including disease transmission or other complications that are suspected of
being directly related to the use of tissue.
• The hospital investigates tissue adverse events, including disease
transmission or other complications that are suspected of being directly
related to the use of tissue.
• As soon as the hospital becomes aware of a post-transplant infection or
other adverse event related to the use of tissue, it reports the infection or
adverse event to the tissue supplier.
• The hospital sequesters tissue whose integrity may have been
compromised or that is reported by the tissue supplier as a suspected cause
of infection.
• The hospital identifies and informs tissue recipients of infection risk when
donors are subsequently found to have human immunodeficiency virus
(HIV), human T-lymphotropic virus-I/II (HTLV-I/II), viral hepatitis, or other
infectious agents known to be transmitted through tissue.
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Diseases Transmitted By Tissue
Transplantation
• Bacteria (multiple strains)
• Hepatitis B
• Hepatitis C
• TB
• HIV
• Rabies
• Creutzfeldt-Jakob Disease (CJD)
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Additional Changes in 2011 JC
Tissue Standards

• Collagen and polymer based implants
specifically exempted
• State-specific designations of tissue products
will now be surveyed, even if not included
under standards
• Hospitals do not have to check FDA
registration for suppliers from which they
purchase products considered tissue by JC but
medical devices by FDA
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General JC - FDA Comparison
• Similarities:
– Both target products that are cellular in nature
– Tissue categories are fairly consistent
• Differences:
– FDA specifically excludes products containing
cells/tissues from animals (i.e. xenografts); JC
specifically includes those products
– FDA classifies some products as medical devices that JC
considers tissue products under the standards
• Medical devices not issued unique ID numbers (e.g. DBM
products)
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• If supplier uses validated shipping containers,
documentation that container is undamaged
upon receipt is acceptable
Additional Changes in 2011 JC
Tissue Standards
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Tissue Management Lifecycle
Trusted Source
Bank / Distributor
Validation
Tissue
Ordering
Tissue
Receipt
Tissue
Inventory
Management
Tissue
Implantation
Tissue
Usage Info
Tracking
Adverse Reaction
Look-Back
Patient
Needs
Tissue
Preparation
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Questions?
DUKE KASPRISIN, M.D.
Chief Medical/Scientific Officer
Biomedical Synergies, Inc.
(802) 658-4862
DukeK@biomedicalsynergies.com
JEFF WINSTEAD
SVP, Business Development
Biomedical Synergies, Inc.
(317) 842-6502
JeffW@biomedicalsynergies.com