JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

21.6: Tissue storage

Refrigeration devices containing tissue shall be suitable for the use intended and procedures for monitoring such devices shall be validated so that tissues are maintained at the required storage temperature. Continuous monitoring and recording of temperature, together with suitable alarm systems, shall be employed on all storage refrigerators, freezers and liquid nitrogen tanks.

Every effort should be made to avoid cross-contamination of material stored in liquid nitrogen vessels. Wherever possible, there should be specifically designated pieces of equipment (e.g. nitrogen level rulers, portable thermometers) for each vessel. Where this is not possible (e.g. liquid nitrogen delivery hoses) and the item has to be used for more than one vessel, it should not come into contact with the liquid phase or the sides of the vessel.

Frozen and cryopreserved tissue should be double wrapped during storage. The seals and the material employed must be validated for their use at the designated storage temperature and the conditions of use, to demonstrate integrity of the packaging and labelling. This is crucially important for storage in liquid nitrogen vessels because of the high levels of accumulated microbial contaminants found within these vessels.

Quarantined and released tissue must be stored in physically segregated, clearly designated locations distinct from each other.

21.6.1: Tissue release

Prior to any tissue being cleared for issue, all relevant records including donor records, processing and storage records, and post-processing quality control test results must have been reviewed, approved and documented as acceptable by the individual(s) responsible according to the relevant local standard operating procedures. Responsibilities for setting policies for exceptional release of tissues reside with the designated medical officer.

21.6.2: Tissue discard

There must be a documented policy for the discard of tissue unsuitable for clinical use. Records should include details of date and method of discard and reason for discard. Tissues for discard should be appropriately handled and disposed of in a manner compliant with local control of infection guidelines.

21.6.3: Labelling and packaging of tissues for issue

Packaging must ensure integrity and maintain sterility of the contents of the final container, and must also comply with current legislation.

The container must be labelled with the graft-specific identification (batch and shipment number if applicable), expiry date and supplying tissue bank, storage instructions and barcoded product description and instruction to see pack insert, as a minimum. In addition, more detailed information should be provided either on the label or package insert or both as follows:

  • sizing information
  • antimicrobial processing procedure used (if applicable)
  • preservative used and its concentration (if applicable)
  • special instructions (e.g. ‘Do not freeze’), thawing, dilution instructions
  • presence of known sensitising substances
  • type and calculated quantity of antibiotics added during processing (if applicable)
  • any other potential residual processing agent
  • RhD type (where appropriate)
  • a statement that the tissue was prepared from a donor who was non-reactive for current mandatory markers of infection, with the added rider that all biological tissue carries some risk of disease transmission
  • results and findings from clinically relevant bacteriological cultures performed on the tissue before final packaging
  • storage instructions
  • instructions for reconstitution (if appropriate)
  • a warning on loss of package integrity
  • instructions on dealing with queries, reporting adverse events/reactions and return or disposal of unsuitable or unused tissue
  • a statement that tissue use must be authorised by a medical/dental practitioner
  • a statement should accompany each tissue product stating that it may not be sterilised after leaving the tissue bank
  • a statement should accompany each package stipulating that each package is for single-patient use only
  • if the package insert carries graft-specific information it must be labelled with the unique graft-specific identification code
  • instructions to the user regarding the need for a documented system for the tracking and follow-up of the fate of the tissue
  • when cells are known to be positive for a relevant infectious disease marker, it must be marked as a BIOLOGICAL HAZARD.

21.6.4: External labelling of the shipping container

For transport, the primary container must be placed in a shipping container that must be labelled with at least the following information:

  • identification of the originating Tissue Establishment, including an address and telephone number
  • identification of the organisation responsible for human application of destination, including address and telephone number
  • a statement that the package contains human tissue/cells and HANDLE WITH CARE
  • where living cells are required for the function of the graft, such as stem cells, gametes and embryos, the following must be added: ‘DO NOT IRRADIATE’
  • recommended transport conditions (e.g. keep cold, in upright position etc.)
  • safety instructions/method of cooling (when applicable).

21.6.5: Distribution

All reasonable efforts must be made to ensure that tissues are sent to qualified individuals/organisations who have accepted responsibility for their proper handling and use. A written agreement must be in place between the Tissue Establishment and the organisation ordering the tissue.

Where tissue is transported in a refrigerated or frozen condition, adequate safeguards should be taken to ensure that the tissue remains at the designated temperature. Monitoring of temperature should be undertaken wherever practicable but if not, the method should at least have been validated to show that appropriate temperatures are maintained.