The orthopaedic surgeon plays a key role

Musculoskeletal allografts are used in a wide variety of orthopaedic surgeries, ranging from anterior cruciate ligament reconstructions to spinal fusions. The orthopaedic surgeon who routinely uses musculoskeletal allografts should have a say about how these tissues are handled and managed at the hospital and surgical center level.

In many hospitals and surgical centers, sales representatives are no longer permitted to deliver a bone or soft-tissue graft directly to a specific surgeon in the surgical suite during a surgical procedure. This shift in delivery method has been made to improve patient safety and strengthen the facility’s Joint Commission accreditation status.

To meet the Joint Commission requirement that hospitals oversee tissue management, a multidisciplinary tissue service oversight committee can be established. In this situation, the input of the orthopaedic surgeon is fundamental.

The tissue oversight committee may be a formal or an informal group depending on the needs of the hospital or surgical center facility. The committee should identify one individual as the overall director to oversee the musculoskeletal tissue program, including the development of ordering parameters and the maintenance of storage areas. Whether a centralized system covering all hospital/surgical center tissue needs or a decentralized system covering only musculoskeletal tissue needs is used, the involvement of the orthopaedic surgeon is paramount.

Role of the oversight committee
The purpose of a tissue service oversight committee is to monitor safety, effectiveness, and availability of tissue grafts. The committee provides oversight support for the individual in charge of the tissue service and ensures that the Joint Commission standards are being met.

The committee should establish the following procedures—and put them in writing:

• vendor qualification
• tissue tracing from receipt through storage, preparation, and use
• identification and reporting of recipient adverse events
• successful handling of tissue product recalls

The oversight committee should also establish guidance for the immediate quarantine and segregation of unused grafts and for the identification and notification of recipients of grafts that have been recalled. Among the factors that should be considered when notifying recipients in the event of a recall are the following:

• consultation with the implanting physician
• the patient’s clinical situation
• the results of a Health Hazard Evaluation, which is an individual evaluation of each episode to assess the risk of transfer of disease or potential harm to the recipient
• local policies that dictate the course of action (ie, who will contact the recipient)

Tissue acquisition and preparation
The Joint Commission requires all facilities to use standardized procedures to acquire, receive, store, prepare, and issue tissue allografts. Individuals should be assigned responsibilities for overseeing the following aspects of the tissue service program:

• All tissues received by the facility should be logged in and the manufacturer’s requirements for transportation and storage should be verified as having been met. For example, when a controlled environment is required (ie, refrigeration, frozen, cryopreserved), maintenance of the proper temperature should be verified. Each shipping container and each allograft package should be examined to ensure that its integrity has been maintained before accepting receipt. Formal documentation—including the name of the individual who performed this task and when it was done—must be provided.
• The facility is responsible for maintaining records that document that the tissue is maintained at required environmental temperatures. Storage equipment must have functional monitoring and alarm systems, and appropriate storage backup systems should be available in the event of equipment malfunction.
• The facility’s recordkeeping system must allow for tracing each allograft from the donor or source facility (tissue bank or distributor) to the patient recipients or document other final disposition (such as discarding or returning the allograft to the tissue bank). Each time the allograft is removed from storage—as well as just prior to its preparation for use—the package integrity must be verified.
• The recipient’s medical record must document the unique identifier of the tissue. The documentation should include the specific identification number of the allograft and the name of the tissue bank source facility and/or distributor. Formal documentation of all recipient use or other final disposition of tissue allografts must be recorded and kept in a centralized area at the hospital or surgical center. Records are required to be retained for a minimum of 10 years, or longer if required by state or federal laws.
• Both the hospital/surgery center and the tissue facility are required to have written procedures for identifying and investigating tissue adverse events, including adverse reactions and other complications suspected to be directly related to the tissue allograft. The hospital/surgery center must notify the tissue supplier without delay when an allograft is suspected as the cause of an adverse event. The tissue facility must have a program in place to handle tissue recalls and be able to institute immediate sequestering of tissues that are in inventory, or trace grafts to each recipient or other final disposition without delay. Record-keeping of these activities is paramount.

Vendor selection
Healthcare facilities should place priority on qualifying tissue vendors and controlling allograft inventories. Having a process in place for evaluating new tissue products and needs will ensure quality, traceability, and suitability for the facility inventory. Hospitals and surgery centers should have an organized way to evaluate vendor qualifications.

The AAOS information statement on the use of musculoskeletal allografts recommends that musculoskeletal tissues be obtained from a vendor accredited by the American Association of Tissue Banks (AATB). Hospitals and surgery centers should establish written policies and/or procedures describing vendor evaluation and qualifications. Vendors should be registered with the U.S. Food and Drug Administration as a tissue establishment and/or a biologics or medical device manufacturer (as appropriate). If the facility is located in or serves a state that requires either licensing or registration, that documentation should also be verified.

The surgeon’s role
The orthopaedic surgeon who frequently uses musculoskeletal tissues in the hospital/surgical center should be an active participant in ensuring standards and regulations are being followed by the surgical facility.

Several publications are available to help individuals and the tissue service oversight committee meet these expectations. The following documents can help facilities meet the Joint Commission requirements pertaining to musculoskeletal allografts and provide further insight into detailed management of musculoskeletal allografts at the hospital or surgical center facility:

• Section III. Transplanting Tissues in the new Transplant Safety Chapter of The Joint Commission’s Comprehensive Accreditation Manual for each of the following: Hospitals, Critical Access Hospitals, Ambulatory Care, Office-based Surgery, and Laboratory
• AABB (previously known as American Association of Blood Banks) Guidelines for Managing Tissue Allografts in Hospitals
• AABB Hospital Tissue Management: A Practitioner’s Handbook
• AATB Standards for Tissue Banking, Section L Tissue Dispensing Services (describes management of tissues in a healthcare facility)

Michael J. Joyce, MD, and Ross M. Wilkins, MD, are members of the AAOS Biological Implants Committee; Scott A. Brubaker, CTBS, is chief policy officer at the AATB. Dr. Joyce reports the following disclosure: Musculoskeletal Transplant Foundation; Dr. Ross reports ties to Wright Medical Technology and AlloSource.

Additional References:

1. The Joint Commission’s Transplant Safety Chapter, 2009
2. AAOS Advisory Statement Use of Musculoskeletal Tissue Allografts
3. AABB Guidelines for Managing Tissue Allografts in Hospitals, 2006
4. AABB Hospital Tissue Management: A Practitioner’s Handbook, 2008
5. American Association of Tissue Bank’s Standards for Tissue Banking, Section L Tissue Dispensing Services, 12^th edition, 2008, McLean, Va.
6. http://orthoinfo.aaos.org/topic.cfm?topic=a00115