Transfer from the Sterile Field

  • Pass autologous tissue that will be stored within the facility off the sterile field as soon as possible.

  • Sequester, identify, and monitor autologous tissue that will be kept on the sterile field before transfer.

  • Keep autologous tissue moist until transfer from the sterile field.

  • Verify the patient’s and tissue’s identity before the tissue is transferred off the sterile field.

  • Use sterile technique when transferring autologous tissue from the sterile field.

  • Do not crush, twist, or otherwise damage the integrity of the tissue.

  • Contain and label autologous tissue intended for delayed replantation or autotransplantation immediately after transfer from the sterile field.

  • Use packaging materials that are:

    • leak proof and puncture resistant

    • designed to prevent the introduction, transmission, or spread of communicable diseases

    • validated to meet the anticipated storage conditions

  • Do not package or store autologous bone in solution.

  • When autologous tissue is placed into a storage container, confirm and document the patient’s identity using:

    • two unique identifiers (eg, patient name and medical record number)

    • the originating source of the tissue including laterality, if applicable

    • the type of tissue

    • the clinical diagnosis

Transferring autologous tissue from the sterile field in a manner that maintains the sterility and integrity of the tissue reduces the exposure of health care personnel to blood, body fluids, and other infectious material and reduces the potential for compromise and contamination of the tissue.

Labeling

  • Label the autograft package as follows:

    • “For Autologous Use Only”

    • “Not Evaluated for Infectious Substances” (if infectious disease testing has not been performed)

    • “Biohazard” (if infectious disease testing was performed and any results were positive, or if donor screening was performed and risk factors were identified)

  • Include on the autograft package label:

    • the expiration date

    • unique patient identifiers

    • the donor classification statement “Autologous Donor”

    • the procedure, date of recovery, and name of the surgeon

    • the tissue type and site, including laterality if applicable

    • the identity of the person who packaged and labeled the autograft

    • the time the autograft was placed into storage and the identity of the person placing it into storage

    • the method of preservation, if applicable

    • the recommended storage temperature and acceptable storage temperature range

    • the method of decontamination and identification of any potential processing or solution residues (eg, antibiotics) if used

    • the manner in which the tissue was recovered and prepared (eg, under aseptic conditions)

  • Use a bar-code labeling system if available.

  • Affix identification labels to the outside of both the inner and outer package and not to the container lid.

  • Confirm autograft tissue identification and labeling among surgical team members during the debriefing.

Containing and labeling autologous tissue immediately after transfer from the sterile field helps prevent contamination, damage, or loss of the autograft. Correctly labeling the autologous tissue may prevent transplantation of the tissue into an unintended recipient.

Contaminated Autografts

  • Take measures to prevent dropping an autograft by:

    • alerting all team members during the preoperative briefing or time out that an autologous graft will be obtained

    • knowing where the graft is at all times during the procedure

    • placing the autologous graft in a labeled, preferably lidded, container

    • limiting handling and exchange of the autologous graft between personnel as much as possible

    • including the location of the autograft in the transfer-of-care report when surgical team members are relieved during the procedure

  • When a autograft is contaminated, conduct a risk assessment with an interdisciplinary team (eg, surgeon, perioperative RN, infection preventionist) to evaluate the benefits and potential harms associated with replantation or autotransplantation of a contaminated autograft compared with other treatment options (eg, discarding the graft and using artificial material).

  • If the team decides to use a contaminated autograft:

    • rinse the contaminated graft in sterile normal saline solution to remove surface debris and contaminants

    • add antibiotics or antiseptics to the solutions used to rinse the autograft

    • take cultures before and after decontamination of the graft to determine the identity of the contaminating microorganism and the level of contamination

    • use pulsatile lavage at a low-pressure setting (eg, 6 lb to 14 lb psi) and use sterile normal saline solution for more thorough cleansing of contaminated bone grafts if indicated (eg, adherent debris)

    • use a separate sterile field for decontaminating the dropped graft

    • implement corrective actions as necessary to maintain the sterility of the primary sterile field (eg, change gowns and gloves after pulsatile lavage of the contaminated graft)

    • do not subject the contaminated graft to the steam sterilization process

    • change the wound classification to Class III, contaminated

    • document the event in a variance report

    • conduct a debriefing session and a root cause analysis with members of the surgical team

  • Do not discard any tissue without confirmation from the surgeon.

The benefits of replantation or autotransplantation of a contaminated autologous graft include reduced cost and surgical time and elimination of the need for a secondary procedure. The harm associated with use of a contaminated autologous graft is the increased potential for the patient to develop a surgical site infection.

Transport and Storage

  • Transport autologous tissue in a manner that:

    • prevents exposure of health care personnel to blood, body fluids, or other potentially infectious materials

    • ensures the confidentiality of protected health information

    • maintains the required temperature and minimizes the risk of degradation or contamination of the autograft

  • Store autologous tissue intended for delayed replantation or autotransplantation in an area that is controlled to prevent mix-ups, contamination, and cross-contamination of tissue and the potential for tissue to be incorrectly distributed.

  • Do not commingle tissue from two or more donors.

  • Keep autologous tissue separated from allografts.

  • If storing autographs and allographs in the same refrigerator:

    • store them separately (eg, allografts stored on the upper shelves and autografts stored on the lower shelves, allografts and autografts placed in separate storage bins)

    • package them using validated packaging materials

    • label them prominently

    • ensure the correct storage conditions exist for all items in the refrigerator or freezer

  • Inventory the number of autografts in storage according to an established schedule and remove and discard them by the expiration date.

  • Remove any autologous tissue that may have been compromised and discard it.

  • Store autologous tissue at temperatures that will prevent contamination or degradation of the tissue.

  • Freeze autografts that are to be frozen within a few hours of recovery.

  • Store autologous tissue that will not be immediately transported to the storage area in a manner that maintains autograft integrity.

  • Document the following when autologous tissue is placed into the refrigerator or freezer for storage:

    • the facility or health care organization-defined unique identifiers (eg, patient’s name and medical record number)

    • the procedure, date of the procedure, and name of surgeon

    • the date and time of tissue storage and the identity of the person placing it into storage

    • whether the tissue was cultured

    • any additional pertinent clinical information (eg, increased potential for autograft contamination because of trauma)

Transporting or storing autologous tissue in a manner that minimizes the risk of degradation or contamination of the autograft is a regulatory requirement for good tissue practice. Degradation of the autograft may increase the potential for an adverse reaction and unexpected outcome for the patient.

Equipment Maintenance

  • Clean, sanitize, and maintain equipment and devices used for storing autologous tissue according to an established schedule to prevent malfunctions, contamination, or cross-contamination.

  • Perform regular calibration checks on equipment used for storage.

  • Keep the record for 3 years after it is created.

  • Monitor temperatures of freezers and refrigerators used for storage continuously, and record temperatures daily.

  • Respond to an alert or alarm that notifies personnel when the temperature is not within the acceptable range.

  • Establish processes for maintaining temperatures in the event a refrigerator or freezer malfunctions (eg, transferring to another storage unit).

  • Do not store autologous tissue on-site if the facility or health care organization is not able to monitor storage conditions when the facility is closed or unoccupied.

Cleaning, sanitizing, and maintaining equipment and devices used for storage of autologous tissue helps to prevent malfunctions, contamination, or other events that may result in the introduction, transmission, or spread of communicable diseases and is a regulatory requirement and an American Association of Tissue Banks standard.

Safe Handling

  • Release autologous tissue only for replantation or autotransplantation in the donor.

  • Use unique identifiers to verify the autologous donor’s identity for release of autologous tissue.

  • Use bar-coding technology if available.

  • Document removal of the autograft from storage, including the date and time of removal and the identity of the person removing the tissue.

  • Do not release the autologous tissue until all handling criteria (ie, processing, labeling, storage, cultures) have been verified and determined to be satisfactory for release.

  • Review the culture results for a stored autograft before the autograft is replanted or autotransplanted.

  • Remove the frozen autograft from the freezer only after the surgeon has confirmed the autograft will be used.

  • Before the tissue is transferred to the sterile field, verify with the surgeon:

    • the contents of the autologous tissue package

    • patient and tissue identification

    • expiration date

    • other pertinent information

  • Remove bone autografts from their packages using sterile technique, and place them into

    • a sterile basin filled with warm (98.6° F to 105.8° F [37° C to 41°C]), sterile normal saline, or lactated Ringer’s solution for 15 to 20 minutes or

    • an empty sterile basin and allow them to thaw at room temperature for a minimum of 30 minutes before replantation or autotransplantation

  • Rinse the autograft at least three times with sterile normal saline or lactated Ringer’s solution before replantation or autotransplantation.

  • Document the

    • date and time of replantation or autotransplantation

    • the procedure used to prepare the autograft

    • the names and titles of all individuals involved in preparing the autograft

  • If the autograft is not replanted or autotransplanted and is transferred to another facility or discarded, provide documentation so that the autograft can be traced to its final disposition.

Handling autologous tissue in a safe manner may help prevent compromise or contamination that could render the autograft unacceptable for replantation and may decrease the patient’s risk for a surgical site infection.