2011 Joint Commission Tissue Standards

1 Copyright ©2011 Biomedical Synergies, Inc. All rights reserved.

DUKE KASPRISIN, M. D.

JEFF WINSTEAD

The 2011 Joint Commission Tissue

Standards: Key Changes and

Common Survey Findings


Agenda

• 2011 Joint Commission tissue standards and

key compliance requirements

• Key differences in 2011 tissue standards

• Common survey findings

• Tissue management lifecycle


• 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


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.




January 2011

TS.03.01.01

The hospital uses standardize procedures

for managing tissue.


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.


• 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)


• 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


• 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



• 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)



• 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




January 2011

TS.03.02.01

The hospital traces all tissues

bi-directionally.


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.


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.


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

– 3rd Edition


• 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




January 2011

TS.03.03.01

The hospital investigates adverse events

related to tissue use or donor infections.


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.


Diseases Transmitted By Tissue

Transplantation

• Bacteria (multiple strains)

• Hepatitis B

• Hepatitis C

• TB

• HIV

• Rabies

• Creutzfeldt-Jakob Disease (CJD)


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


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)


• If supplier uses validated shipping containers, documentation that container is undamaged upon receipt is acceptable

Additional Changes in 2011 JC

Tissue Standards


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


Questions?

DUKE KASPRISIN, M.D. Chief Medical/Scientific Officer

Biomedical Synergies, Inc.

(802) 658-4862

[email protected]

JEFF WINSTEAD SVP, Business Development

Biomedical Synergies, Inc.

(317) 842-6502

[email protected]

mailto:[email protected]

mailto:[email protected]

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2011 Joint Commission Tissue Standards

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