The hospital uses standardized procedures for managing tissues.

(1)

The hospital develops and implements standardized written procedures for the acquisition, receipt, storage, and issuance of tissues.

(2)

The hospital confirms that tissue suppliers are registered with the US Food and Drug Administration (FDA) as a tissue establishment and maintain a state license when required. Note 1: 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. Note 2: The supplier’s FDA registration status may also be checked annually using the FDA's online database: https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/find-tissue-establishment.

(3)

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

(4)

The hospital maintains daily records to demonstrate that tissues requiring a controlled environment are stored at the required temperatures. Note 1: Types of tissue storage include room temperature, refrigerated, frozen (for example, deep freezing colder than -40°C), 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.

(5)

The hospital 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.

(6)

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

(7)

In Department of Defense hospitals, Veterans Affairs medical centers, and other federally administered health care agencies, notification to the organ procurement organization of patients who have died or whose death is imminent is done according to procedures approved by the respective agency.