Clarification of tissue storage requirements

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Thank you for your efforts to help health care organizations meet the Joint Commission's standards for tissue storage and issuance.¹ In the October 2008 Clinical Issues column, the segment titled “Temperature monitoring of tissue products” (Vol 88, No 4, pages 631–634) explains how health care organizations can meet the Joint Commission requirements for verification of package integrity and acceptable transport temperatures at the time of tissue receipt. Some questions related to these requirements have been received by the Joint Commission and the American Association of Tissue Banks (AATB), and we would like to clarify the Joint Commission requirements for the various temperature storage types.

Upon receipt of tissue, the health care organization is required to verify and document that the recommended temperature and the integrity of the individual tissue packaging was maintained during transport for tissues requiring a controlled environment. In all cases, the health care organization is required to verify that the package integrity is acceptable, which includes confirming that the product is within its expiration date.

Tissues requiring “ambient temperature”—generally defined as the temperature of the immediate environment—for transport and storage do not need to have the temperature verified on receipt. Alternatively, the temperatures of tissues requiring “room temperature” storage should be verified and documented if the manufacturer has specified a temperature storage range in the package inserts.

For refrigerated and frozen tissue products, many distributors use validated shipping containers that are tested to maintain the recommended temperature for a specified period of time. Often, the distributor provides documentation regarding the specifications for the health care organization to have on file. In this case, the receiver of the tissue simply needs to check that the shipping container is received undamaged and within the validated time frame. If the distributor does not provide a validated shipping container, other checks that can be performed to meet this requirement include noting the presence of any remaining regular or dry ice; taking the temperature within the box (ie, in the center of the product); or using a commercial shipping temperature indicator.

The Joint Commission implemented its standards on tissue storage and issuance for Ambulatory Care, Critical Access Hospital, Hospital, and Office-Based Surgery Accreditation programs in July of 2005. These standards were also revised for the Laboratory Accreditation program.

The AATB Standards for Tissue Banking² are in agreement with the Joint Commission's requirements for receipt of tissue as described above. Lyophilized (ie, freeze-dried) musculoskeletal allografts may contain instructions to store at “ambient temperature or colder,” which is a broad temperature range that does not require monitoring. Musculoskeletal allografts (ie, bone, soft tissue), when lyophilized and vacuum packaged, become heat resistant. This tissue can withstand temperature excursions as high as 50° C (122° F) for up to a few days without damage to collagen or growth factors (ie, proteins), or mineral components of the allograft.³ Stability of these components relate to the graft's ability to offer structural support and remodeling. Lyophilized tissue is not damaged by low temperatures, and it is useful to know that temperatures well below freezing are part of the lyophilization process.¹ Verifying the integrity of the allograft's immediate packaging as well as the shipping container are very important quality control steps when an allograft shipment is received. The graft's immediate packaging should be inspected again when it is issued for use after storage.

The AATB's Standards for Tissue Banking describe at H3.300 Validation and Expiration of Transport Container, that

If tissue to be shipped requires specific environmental conditions other than ambient temperature, the capability of the transport container to maintain the required environmental conditions shall be demonstrated and documented in a validation study. The length of time that these conditions can be maintained by the transport container, assuming normal handling, shall also be determined and documented. Expiration dates of the transport container shall be noted on the outside of the transport container.²

The quantity and type of refrigerant must also be designated on the outside of the transport container (refer to standard G3.300 Transport Package Label Content²). Tissue requiring specific environmental conditions for transport and storage include those that must be refrigerated, kept frozen, or are cryopreserved. Questions regarding these or other AATB standards can be directed to Scott Brubaker at the AATB Executive Office (brubakers@aatb.org). For storage and handling requirements for specific allografts provided by tissue suppliers, refer to instructions provided in the graft's package insert or contact representatives at the tissue source facility (ie, the processing tissue bank).

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References 

1. Transplant safety . In: Comprehensive Accreditation Manual for Hospitals: The Official Handbook . Oakbrook Terrace, IL: The Joint Commission; 2009;p. TS-1–TS-8
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2. Standards for Tissue Banking . 12th ed.. McLean, VA: American Association of Tissue Banks; 2008;
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3. Shimp L . Heat resistance of allograft tissue . Cell Tissue Bank . 2008;9(4):259–266 Epub March 14, 2008.
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