The 2012 Hospital & Laboratory Accreditation Standards

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).

A 2. 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 2: 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.