Recommended practices for surgical tissue banking

AORN Journal,  Feb, 2006  

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6. Verification of tissue availability should be incorporated into the verification process used to ensure the correct patient, procedure, site, position, and implants. (30)

7. The contents of the package, expiration date, and other pertinent information should be read back and verified before the tissue is dispensed onto the sterile field. Use of bar coding technology facilitates matching tissue to the desired recipient and keeping accurate records.

RECOMMENDED PRACTICE XIII

Each tissue bank must maintain donor, tissue, and recipient records to ensure that pertinent data are retrievable.

1. The surgical tissue bank should have a tissue identification system that allows for tracking of tissues from the donor source to the recipient patient or institution, and vice versa? Quality control issues and infections from implanted tissue have been reported. An identification system provides a means to determine what tissue is affected, rapidly quarantine the tissue, and follow up with affected recipients to ensure timely intervention to minimize morbidity.

2. Surgical tissue banks procuring, processing, distributing, and storing tissues should keep accurate records of the distribution of each tissue according to donor identification number, tissue type and identifying number, and identifying information for the receiving center, along with the dates of recovery and distribution. (6) This information provides a means to recall tissue that may be compromised.

3. Records should be developed and maintained according to the recommendations of AATB and in compliance with FDA rules. Records should include the following information:

* FDA registration, if applicable;

* copies of FDA registration and AATB accreditation of outside vendors from whom tissue is obtained (EBAA for ocular tissue, AABB for stem cells);

* listing of all tissue products ordered, stored, and used;

* informed consent documents;

* donor suitability assessment criteria;

* recovery;

* processing;

* preservation;

* labeling;

* storage;

* quarantining;

* testing record review;

* releasing;

* distribution;

* ordering and receipt of tissue acquired from other sources:

** package integrity upon receipt,

** transport temperature controlled and acceptable, and

** source facility and unique identifier of the tissue;

* instructions/procedures for reconstitution;

* identity of personnel preparing, accepting, and issuing tissue;

* dates and times of preparing, accepting, and issuing tissue;

* documentation in the recipient's health record of the unique identifier of the tissue;

* quality management records;

* recall criteria and procedures; and

* disposal of tissue.

For tissue obtained from outside tissue banks, copies of pertinent records should be forwarded to the source facility. Documentation assists in clinical evaluation and in tracking recipients if an adverse event is identified. (6)

4. Records must be maintained for 10 years after tissue is dispensed or the tissue expiration date is reached, whichever is longer? Tissue may be used years after recovery. For that reason, the FDA requires that records must be maintained for 10 years.