CIHQ-ARS Blog

Organizations must ensure that tissue implanted into a patient is managed in a safe and effective manner. Each organization that uses tissue should determine a process to receive tissue from the supplier and then transport it to the designated area. This process should include an inspection of the packaging upon receipt to ensure its integrity and that the temperature was maintained throughout transport. The tissue should not be accepted if:

• The container seal is not intact or has any physical damage
• The label or identifying information is missing or not readable, or
• If temperature requirements have not been maintained

Each article of tissue shall be tracked upon receipt from the tissue supplier to its use and / or implantation into a patient or return to supplier. Each organization must determine the specific method to document the following for each article of tissue:

• Date and time the tissue was received into the organization.
• Identity of the person who received the tissue.
• Verification that the temperature and package integrity of the tissue was maintained when the tissue was received.
• Type of tissue, lot number, and expiration date.
• Date and time the tissue was removed from storage for implantation.
• Identity of the person who removed the tissue from storage for implantation.
• Disposition of the tissue - either implantation or return to supplier.
• The name, lot number and expiration date of any materials used to reconstitute or prepare the tissue.

Tissue Storage
Tissue shall be stored in a manner consistent with the instructions of the source facility and / or manufacturer. This may include ambient temperature, room temperature, refrigeration, frozen, or deep freezing. Refrigerators, freezers, and nitrogen tanks that store tissue must be maintained at appropriate temperatures. They shall be continuously monitored and documented daily. Tissue requiring room temperature storage must have the storage area temperature documented daily. Tissue, however, requiring ambient temperature does not need to be documented. Refrigerators and freezers shall:

• Be plugged into emergency power
• Have an alarm that is audible to staff 24/7 to notify the organization when the temperature is not maintained
• Have the temperature continuously monitored and documented at least daily

What to expect during a survey?
During a survey, the surveyor will trace tissue from arrival to implantation / return. The surveyor will ask to see the following:

• Source facilities current tissue registration with the FDA.
• Source facilities state license if applicable.
• Documentation of all the elements described above.
• Review medical record for documentation of tissue:
  • The type of tissue used / implanted
  • The donor and lot identification number
  • The date and time the tissue was used / implanted
  • The identity (name and title) of staff involved in the preparation and use / implantation of the tissue.
• Temperature logs

In conclusion, tracking of implanted tissue is a patient safety concern. Temperatures must be monitored and recorded in areas where tissue is stored. Records should:

• Permit bidirectional tracing of any tissue to report potential disease transmission to the recipient when notified by the donor source facility
• Reporting of adverse patient reactions to the donor source facility, and
• Investigation for the chain of events (e.g., who handled the tissue), how it was transported, stored, and processed, including dates and times of such activities.

Storage temperatures and tissue records should be maintained for a minimum of 10 years or as required by state law and regulation.

References:
Center for Improvement in Healthcare Quality, Standard LB-6
The Joint Commission, Standard TS.03.01.01, TS.03.02.01, TS.03.03.01