Return of Body Tissue or Explanted Materials to Patients

When Kristi Loyall was diagnosed with a rare soft tissue tumor in her right foot, her oncologist recommended amputation. After recovering from the surprise of receiving a cancer diagnosis, she asked her oncologist if she could keep her amputated foot. When he realized that her request was sincere, the oncologist told her that her request could likely be accommodated. A short time later, Kristi signed some paperwork and underwent surgery. The next month, she went to the pathology department at the hospital and took possession of a red biohazard bag which contained her amputated foot. Kristi sent the foot to a company that cleans skeletons, and several months later, the newly cleaned, whitened, and articulated skeletal foot was returned to her. Kristi posts photos of her foot on social media.

There are many reasons why patients may want to keep removed body tissues or explanted materials. Religious traditions or cultural practices may require the burial of amputated limbs. New parents may ask for a placenta so they can eat, bury, or plant it. Patients involved in actual or potential litigation may need explanted materials as evidence. Other patients may simply want them as mementos. 

Regardless of the reason, these requests are becoming more commonplace, but they often take hospital personnel by surprise. While personnel may want to accommodate patients, organizational policies regarding medical waste disposal may be silent or murky on this issue. Even if relevant policies and procedures are in place, they may not clearly outline the process of preserving, packaging, and delivering body tissues and explanted materials to the patient. 
 

Risk Recommendations:

 
Accommodating these requests requires careful consideration, preparation, and well-crafted policies and procedures that are consistent with state law. Consider the following when reviewing or developing a policy addressing requests to return body tissues or explanted materials:

Know the law. State law typically categorizes body tissues, fluids, or materials as medical waste that require disposal in a specific fashion. Some states have laws allowing patients to take possession of certain types of medical waste, such as placental tissue. Failure to comply with regulatory and legal requirements regarding medical waste disposal may result in fines and/or compromise a facility’s license to operate. Consult an attorney for guidance in drafting policies and procedures that comply with applicable laws and regulations.

Create a policy. Collaborate with a multidisciplinary team to develop policies and procedures regarding patient requests to return body tissues and explanted materials. Ensure that policies and procedures include these key elements: 

• Circumstances in which such items can be released to the patient.
• Circumstances in which such items cannot be released to the patient, like when: 
  • Additional laboratory or pathology testing is needed.
  • Defective devices must be returned to the manufacturer.
  • Requested materials may be used as evidence in a lawsuit.
  • Infectious disease is present.
  • Release is prohibited by law.
• Requirements for informed consent, including minor consent.
• Guidelines for repairing, storing, packaging, transporting, and releasing the material.

Obtain written consent. If a patient requests to keep body tissues or explanted materials, obtain written informed consent. The informed consent discussion can help set patient expectations. Thoroughly discuss the risks associated with taking possession of the material, including infectious disease or damage/destruction/deterioration associated with transportation of the material. Confirm with legal counsel when necessary to ensure that the consent form complies with all applicable laws and that related discussions with the patient are well-documented in the medical record. 

Coordinate services. Commercial vendors or funeral homes may be involved in handling body tissues or explanted materials. Direct communication with these vendors may be necessary or helpful to understand the requirements for preserving and transporting amputated limbs, tissues, or materials. Obtain the patient’s consent to communicate directly with such vendors. 

Prepare practitioners and staff. Requests for return of body tissues or explanted devices may take staff and practitioners by surprise. In order to minimize disruption and to ensure consistent, compliant responses, familiarize staff and practitioners with organizational policies and procedures regarding return of body tissues or explanted materials to requesting patients. Encourage practitioners to discuss this process with patients in advance to set expectations, uncover barriers, and allow patients ample time to complete required paperwork. If the patient’s request conflicts with hospital policy and the conflict cannot be resolved, consult an attorney for further guidance. 

Develop guidelines for explanted devices. Surgically explanted medical devices require special handling, especially if they are defective or may be used as evidence in a lawsuit. Work with an attorney to develop organizational guidelines and policies regarding the reporting, handling, retaining, and disposal of medical devices. Ensure that policies and procedure address requirements for chain of custody documentation.

Requests for the return of body tissues and explanted materials are becoming more common. Be prepared to accommodate these requests, when possible, with well-crafted policies, staff education, and streamlined processes. And, as always, clear communication with patients can help set expectations and establish mutual understanding.
 


Copyrighted. No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.