Introduction to Standards TS.03.01.01, TS.03.02.01, and TS.03.03.01

The following standards apply to hospitals that store or issue tissue. This includes any areas outside of the clinical laboratory that store or issue tissue; for example, surgery and outpatient centers or tissue banks. They apply to human and nonhuman cellular-based transplantable and implantable products whether classified by the U.S. Food and Drug Administration (FDA) as a tissue or a medical device. Collagen and tissue products derived from plastics and polymers are not considered cellular-based products and are not evaluated under these standards.

Specific tissue transplant requirements apply to autologous tissue. This includes policies and procedures for identifying, tracking, storing, and handling atuologous tissue, in addition to investigating tissue adverse events. Also, if the state in which an organization resides classifies something as tissue that falls outside the scope of The Joint Commission definitions, the standards would apply.

Examples of Tissue and Cell Products
The organization uses standardized procedures to acquire, receive, store, and issue tissues.

• 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 Cells
• Leukocytes
• Ligaments
• Limbal Graft
• Limbal Stem Cells
• Lymphocytes
• Marrow
• Membrane
• Meniscus
• Nerves
• Non-valved Conduits
• Oocyte/Ovarian Cells
• Parathyroid
• Pancreatic Islet Cells
• 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 classifies as tissues by state law and regulation.

Standard TS.03.01.01
The hospital uses standardized procedures for managing tissues.

Elements of Performance for TS.03.01.01

A 1. The hospital assigns responsibility to one or more individuals for overseeing the acquisition, receipt, storage, and issuance of tissues throughout the hospital.
Note: Responsibility for this oversight involves coordinating efforts to provide standardized practices throughout the hospital. A hospital may have a centralized process (one department responsible for the ordering, receipt, storage, and issuance of tissue throughout the hospital) or a decentralized process (multiple departments responsible for the ordering, receipt, storage, and issuance of tissue throughout the hospital).

A2. The hospital develops and maintains standardized written procedures for the acquisition, receipt, storage, and issuance of tissue. (See also TS.03.02.01, EP5)

A 3. 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.*
Note: This element of performance does not apply to autologous tissue or cellular-based products considered tissue for the purposes of these standards but classified as medical devices by the FDA.

A 4. The hospital coordinated its acquisitions, receipt, storage, and issuance of tissues throughout the hospital.

A 5. The hospital follows the tissue suppliers’ or manufacturers’ written directions for transporting, handling, storing, and using tissue.

C 6. The hospital documents the receipt of all tissues. (See also TS.03.02.01, EPs 3 and 6)

C 7. The hospital verifies at the time of receipt that package integrity is met and Transport temperature range was controlled and acceptable for tissue requiring a controlled environment. This verification is documented. (See also TS.03.02.01, EP 6)
Note 1: If the distributor uses validated shipping containers, the receiver may document that the shipping container was received undamaged and within the stated time frame.
Note 2: Tissues requiring no greater control than "ambient temperature" (generally defined as the temperature of the immediate environment) for transport and storage would not need to have the temperature verified on receipt.

C 8. The hospital maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required temperatures. (See also TS.03.02.01, EP 5)
Note 1: Types of tissue storage include room temperature, refrigerated, frozen (for example, deep freezing colder than -40C), and liquid nitrogen storage.
Note 2: Tissues requiring no greater control than "ambient temperature" (defined as the temperature of the immediate environment) for storage would not require temperature monitoring.

A 9. The hospital/organization continuously monitors the temperature of refrigerators, freezers, nitrogen tanks, and other storage equipment used to store tissues.
Note 1: Continuous temperature recording is not required but may be available with some continuous temperature monitoring systems.
Note: For tissue stored at room temperature, continuous temperature monitoring is not required.

A 10. Refrigerators, freezers, nitrogen tanks, and other storage equipments used to store tissues at a controlled temperature have functional alarms and an emergency back up plan.
Note: For tissue stored at room temperature, alarm systems are not required.

A 11. The hospital/organization complies with state and/or federal regulations when it acts as a tissue supplier.
Note: The U.S. Food and Drug Administration (FDA) considers the routine policy or practice of shipping tissue to another facility as distribution which requires FDA registration. Returning unused tissue back to the tissue supplier is not considered distribution and does not require FDA registration.

Standard TS.03.02.01
The hospital/organization traces all tissues bi-directionally.

Elements of Performance for TS.03.02.01

A 1. The hospital's or organization’s records allow any tissue to be traced from the donor or tissue supplier to the recipient(s) or other final disposition, including discard, and from the recipients(s) or other final disposition back to the donor or tissue supplier.

C 2. The hospital/organization identifies, in writing, the materials and related instructions used to prepare or process tissues.

C 3. The hospital/organization documents the dates, times, and staff involved when tissue is accepted, prepared, and issued. (See also TS.03.01.01, EP 6)

A 4. The hospital/organization documents in the recipient’s medical record the tissue type and its unique identifier.

A 5. The hospital/organization 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/organizations may have to retain tissue records longer than 10 years. (See also TS.03.01.01 EPs 2 and 8)

A 6. The hospital/organization retains tissue records for a minimum of 10 years beyond the date of distribution, transplantation, disposition, or expiration of tissue (whichever is latest). If required by state and/or federal laws, hospitals/organizations may have to retain tissue records longer than 10 years. Records are kept on all of the following:

• The Tissue Supplier
  Note: For medical devices, the manufacturer may be the tissue supplier
• The original numeric or alphanumeric donor and lot identification
• The name(s) of the recipient(s) or the final disposition of each tissue
• The expiration dates of all tissue

A 7. The hospital/organization completes and returns tissue usage information cards requested by the tissue supplier.*

Standards TS.03.03.01
The hospital/organization investigates adverse events related to tissue use or donor infections.

Elements of Performance for TS.03.03.01

A 1. The hospital/organization 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.

A 2. The hospital/organization investigates tissue adverse events, including disease transmission or other complications that are suspected of being directly related to the use of tissue (See also IC.01.03.01 EP 3)

A 3. As soon as the hospital/organization 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.

A 4. The hospital/organization sequesters tissue whose integrity may have been compromised or that is reported by the tissue supplier as a suspected cause of infection.

A 5. The hospital/organization 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.

**According to Health Insurance Portability and Accountability Act (HIPPA) regulations regarding protected health information, “a covered entity may disclose protected health information for public health activities or other purposes to a person subject to the jurisdiction of the Food and Drug Administration (FDA) for the following purposes:

• To track products if the disclosure is made to a person required or directed by the FDA to track the product.
• To enable product recalls, repairs or replacement (including locating and notifying individuals who have received products of product recalls, withdrawals, or other problems” (45CFR 164.512(b) (iii) (B) and (C)).