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Hospitals, Hospice, &
Nursing Homes

Most, but not all deaths occur at hospitals.  For deaths occurring at hospitals, an established process of referring the death information to a donation agency exists.  In order for those dying in hospice or nursing homes to have access to donation, special actions are needed.

A patient lies in a hospital bed, we do not see their face. They have an oxygen monitor on their finger

A patient has died. To what donation agency should this death be referred? Do I need to contact all donation agencies?

Per CMS regulation, a hospital must refer every death to the OPO (Organ Procurement Organization) federally designated to serve that hospital, to an eye bank, and to a tissue bank with whom the hospital has an agreement for services (having such agreements is also required by CMS). By agreement with our hospitals, LifeNet Health and the Lions Medical Eye Bank and Research Center of Eastern Virginia have chosen to make the 

referral process a single phone call. The OPO (LifeNet Health in the Hampton Roads), the tissue bank (also LifeNet Health), and the eye bank (Lions Medical Eye Bank and Research Center of Eastern Virginia) have trained staff whose job is to examine, case-by-case, whether or not a patient is eligible for donation. The OPO or applicable agency will ask a series of questions to determine eligibility for organ, tissue, and eye donation. If the patient is suitable for eye or cornea donation, exclusive or inclusive of organ/tissue donation, the eye bank receives the referral and all information gathered up to that point from the OPO. The OPO will remain the one donation organization to contact the hospital if organ and/or tissue donation remains a potential, even if eye donation potential is involved. This reduces the burden on hospital staff with respect to the donation process.

Whose responsibility at the hospital is it to refer a death to the OPO?

Every hospital has their own protocol for who is responsible for calling a referral to the OPO and/or who is the contact person throughout the screening process. Commonly, a nurse or nursing supervisor is responsible for referring a death. A best practice for the point of contact in the screening process is to

By agreement with our hospitals, LifeNet Health and the Lions Medical Eye Bank have chosen to make the referral process a single phone call.

put a nurse who cared for the patient on the phone with the donation agency to best facilitate screening by someone familiar with the patient’s history and dying process.

 

I heard that if a person has cancer, he or she couldn’t donate anything. Is this true?

Most cancers do not rule out eye or cornea donation. Corneas are avascular tissues that are isolated in the eyes, which are organs remote to most metastases. With few exceptions, a patient with cancer history is likely eligible to donate corneas for transplantation.

Under what circumstances is a patient not suitable for donation?

Every patient’s medical and social history is considered on a case-by-case basis. Eligibility criteria are constantly under review. Donor eligibility criteria are not only set by the U.S. Food and Drug Administration, but by the Eye Bank Association of America, the Commonwealth of Virginia, and the Medical Directors of the Lions Medical Eye Bank and Research Center of Eastern Virginia. In addition to criteria to evaluate safety of tissue for transplant purposes, there are criteria to determine whether donated tissue may be found safe for research, medical education, or training. Our staff receives ongoing training to ensure the safety of the tissue to be transplanted or used for research or medical education, as well as to ensure the safety of eye bank staff who may be exposed to a patient. Screening a patient with the hospital staff, the family, medical examiners, and autopsy technicians is only the beginning of the determination of donor eligibility that occurs. Preservation by strict procedure, testing of blood for a variety of pathogens using several different tests, follow-up on pre-mortem microbiological testing performed, and evaluation of tissue using two different microscopes are just some of the further activities that must occur to ensure safe tissue is available for transplantation.

How long after death can donation occur?

It is critical that hospital staff refer a death to the OPO within 1 hour of cardiac death or brain death. Preferably, donation will occur within 8 hours. As stewards of the donated gifts, the eye bank only pursues donation from donors whose tissue is determined to be safe and with qualities that may restore sight to recipients or further medical skill or scientific understanding. LifeNet Health and the Lions Medical Eye Bank both have staff that are compassionate and well-trained to handle the sensitive task of speaking to the families who have recently lost a loved 

A nurse comforts a family member by their loved one's hospital bed.

one to discuss their loved one’s decision to donate, or to offer the option of donation without pressure. Both agencies respect the wishes of the donor and next-of-kin throughout discussions about donation and work toward a goal of recovering tissue in the shortest amount of time possible to ensure the highest medical and scientific quality of the donated gifts.

A patient dies at home or in an assisted living facility under hospice care, does this patient’s death need to be referred? Who is responsible for referring?

There is little regulation regarding deaths outside of the hospital setting. When a patient dies outside of a hospital and law enforcement is involved in the death reporting, law enforcement is, according to Virginia law, to refer a case. However, this practice is in its infancy. If a dying hospice patient indicated a desire to donate, anyone can refer the case. This includes hospice staff, family, or staff at the assisted living facility or nursing home, or even clergy. Though each family should be able to honor the wishes of their loved one or given an option to donate, a referral, followed by appropriate donor screening must occur first. It takes love and compassion from individuals who may not even have an association with the deceased to make this system work for those who die outside of a hospital.

 

Do I need to perform any patient care to facilitate successful donation?

The eye bank does ask for post-mortem eye care to facilitate successful donation and assist with optimal post-mortem presentation of a decedent during possible funeral viewing.  The eye bank provides “eye prep kits” to hospitals.  These kits contain headblocks to elevate the head about 30º, sterile saline to irrigate the eyes, and plastic bags to contain a small amount of ice to place over closed eyelids.  If you’re in a facility without access to these items, do not irrigate the eyes, but do elevate the head.  You may use plastic bags or (clean) disposable gloves to contain a small amount of ice to place over closed eyelids.

When may a body be released to a funeral home?

After receiving the death referral, donation agencies must screen the donor.  If eligible, the donation agencies contact the family to discuss donation.  If authorized, the donation agencies will dispatch technicians for surgical recovery procedures.  At any point in the process, the donation agencies may release the donation agency “hold” on the body.  The donation agencies request that hospitals not release the bodies to the funeral home until the process is complete.  Donation agencies’ processes include training to release bodies as soon as possible within the process (e.g. upon learning that a donor is ineligible, upon learning that a family does not support donation, or upon completion of tissue recovery).  If there are any questions about status of a case or whether a body may be released, hospital staff and funeral homes are encouraged to contact the eye bank at 757-388-5809 to discuss with an eye bank Donor Coordinator.

Patient Privacy is Key

How does the eye bank handle personal health information?

Under HIPAA (Health Information Portability and Accountability Act), donation agencies are exempt, due to the individual’s death rendering the individual unable to serve as subject to the law (e.g. unable to sign information releases).

 

“Covered entities and organizations involved in organ procurement, banking, or transplantation of cadaveric eyes, organs or tissue may, without a business associate agreement, use and disclose information for the purpose of facilitating donation and transplantation. The use and disclosure of information for this purpose is allowed by the HIPAA Privacy Rule at 45 C.F.R. 164.512(h).  The HHS response at 65 Fed. Reg. 82572 states that the Privacy Rule "explicitly permits a covered entity to disclose protected health information [as allowed by 45 C.F.R. 164.512(h)] without authorization, consent, or agreement."  Therefore, protected health information may be disclosed to organ procurement organizations for the purpose of facilitating donation and transplantation, and it is not necessary to have business associate agreements in place between the organ procurement organization and the hospitals.”

 

Medical facilities and their agents (e.g. hospice and their staff) are protected when releasing information to donation agencies.

What medical information will the eye bank need to review to determine donor eligibility?

Below is a list of items that the eye bank Donor Coordinator reviews.  For any given patient, the available information may exceed or fall well short of the scope of information we seek.  Regardless, the following list provides a guide for medical professionals to use for preparation.  Facilities may have agreements ensuring secure access for eye bank Donor Coordinators to hospital EMR systems, reducing the burden of verbal information transfer.

  • History and physical

  • Consults (Recent)

  • Registration form (Recent)

  • Prehospital treatment (Recent)

  • Admitting form (Recent)

  • Radiology records (Recent)

  • Progress notes (Recent)

  • Operative reports

    • From current admit or containing information about possible dura mater transplant, xenotransplant, or other transplant information from any time in the patient’s history.

  • Physician orders (Recent)

  • Transfusion records (Last 72 hours only)

  • Laboratory reports (Recent)

  • Cultures (Recent)

  • Medications (Recent)

  • Vent Records (Recent.)

    • Must demonstrate start and end times.

  • Death note

Speaking with Donors' Families

A view from above of the hands of a chaplain holding the hands of a loved one who is grieving a family member

Should nursing staff approach a family regarding donation?

Nursing staff is advised not to approach a family about donation ever. Unless nursing staff is trained as a “Designated Requestor,” CMS regulations forbid a donation approach. The main reason for this is that a determination of donor eligibility must be made before an approach for donation occurs. Second, every family deserves the option of donation to be presented by individuals knowledgeable in the subject and able to answer their questions about donation.

How does the eye bank approach a family regarding donation?

Once a potential donor is identified as eligible to donate, the eye bank seeks authorization to donate.  The eye bank checks the state donor registry for documentation of First-Person Consent (registered donor).  Below are the scenarios, clearly delineated, that may apply any given patient (in descending order of frequency).

  • Cardiac death.  Eligible for eye donation only.  Registered donor.

    • In this scenario, the eye bank Donor Coordinator broaches the subject of donation and informs the family that the patient is an eligible and registered donor.  In this discussion, the eye bank Donor Coordinator seeks to inform the family, gain their support for their loved one’s decision, and collect information to facilitate cornea or whole eye donation.

  • Cardiac death.  Eligible for eye donation only.  Not a registered donor.

    • In this scenario, the eye bank Donor Coordinator approaches the family to offer the option of cornea or whole eye donation.  The eye bank Donor Coordinator discusses the process with the family and collects information to facilitate cornea or whole eye donation once authorization from the family has been obtained.

  • Cardiac death.  Eligible for tissue and eye donation.  Registered donor.

    • In this scenario, the tissue bank Donor Coordinator broaches the subject of donation and informs the family that the patient is an eligible and registered donor.  In this discussion, the tissue bank Donor Coordinator seeks to inform the family, gain their support for their loved one’s decision, and collect information to facilitate tissue donation and cornea or whole eye donation.  The tissue bank Donor Coordinator shares the documentation with the eye bank Donor Coordinator.

  • Cardiac death.  Eligible for tissue and eye donation.  Not a registered donor.

    • In this scenario, the tissue bank Donor Coordinator approaches the family to offer the option of tissue donation and cornea or whole eye donation.  The tissue bank Donor Coordinator discusses the process with the family and collects information to facilitate tissue donation and cornea or whole eye donation once authorization from the family has been obtained.  The tissue bank Donor Coordinator shares the documentation with the eye bank Donor Coordinator.

  • Brain death.  Eligible for organ, tissue, and eye donation.  Registered donor.

    • In this scenario, the organ bank Donor Coordinator broaches the subject of donation and informs the family that the patient is an eligible and registered donor.  In this discussion, the organ bank Donor Coordinator seeks to inform the family, gain their support for their loved one’s decision, and collect information to facilitate organ and tissue donation, as well as cornea or whole eye donation.  The organ bank Donor Coordinator shares the documentation with the tissue bank and eye bank Donor Coordinators.

  • Brain death.  Eligible for tissue and eye donation.  Not a registered donor.

    • In this scenario, the organ bank Donor Coordinator approaches the family to offer the option of tissue donation and cornea or whole eye donation.  The organ bank Donor Coordinator discusses the process with the family and collects information to facilitate organ and tissue donation, as well as cornea or whole eye donation once authorization from the family has been obtained.  The organ bank Donor Coordinator shares the documentation with the tissue bank and eye bank Donor Coordinators.

 

In Hampton Roads, the donation agencies are as follows:

Organ Procurement Organization – LifeNet Health (federally designated)

Tissue Bank – LifeNet Health

Eye Bank – Lions Medical Eye Bank and Research Center of Eastern Virginia

Rules and Regulations

What Laws Protect the Right to Donate?

In the U.S., there has been significant legislation to facilitate donation, especially with regard to who may make a legal document of anatomical gift for a decedent.

 

In 1968, Congress passed the Uniform Anatomical Gift Act (UAGA), legalizing the donation of organs and tissues. The 1968 UAGA stipulated for the first time that an individual, prior to death, could irrevocably donate his or her organs for medical purposes by signing a simple document before witnesses. As simple as this seems, this was a departure from centuries of common-law precedent, in which the body immediately after death became the property of the next-of-kin.

In 1984, the National Organ Transplant Act (NOTA) established the framework for the Organ Procurement and Transplantation Network (OPTN). In 1986, the United Network for Organ Sharing (UNOS) was established and the Consolidated Omnibus Budget Reconciliation Act of 1986 requires that all families of potential donors, who are not registered donors, be approached for donation. As a result of the 1986 legislation, hospitals not complying with the law would be ineligible for Medicare benefits. By 1988, the Joint Commission on Accreditation of Health Care Organizations (JCAHO) set donor standards and required hospital policies and procedures for organ and tissue procurement.

Revisions to the UAGA on the federal level have occurred in 1987 and 2006, resulting in a few changes, including that a legal document of gift, signed by the individual, does not need to be witnessed; and in the event that there is an absence of documentation left by the individual, there is an expanded list of persons, in an order of priority, who may make an anatomical gift on behalf of the deceased. The Revised Uniform Anatomical Gift Act (rev. 2007) has been adopted by all 50 states, and therefore is standardized across the USA. You can read Virginia's law for yourself here.

What rules does my hospital have to follow regarding organ and tissue donation?

You can read the full text of the state and federal laws, along with the CMS requirements for  hospitals and organ procurement organizations here:

Professionals in scrubs stand in a semi-circle with their hands in the center showing solidarity with each other

Some key points to remember:

  • All hospitals are required by federal law to have a relationship with a local organ, tissue, and eye procurement organization.

  • All deaths must be reported to these local donation agencies in a timely manner to allow the OPO to screen all hospital deaths for the potential for organ, tissue, and eye donation.

    • Although “timeliness” is defined by the hospital, CMS states that hospital notification of the OPO within one hour of cardiac death is ideal for preserving the opportunity for donation of tissues and eyes.

  • The OPO determines medical suitability. No physician or nurse or any other caregiver in the hospital is allowed to make decisions about patient medical suitability for organ, tissue, or eye donation.

  • Only an OPO staff member or a trained, designated requester may approach the family of a potential donor for consent for organ, tissue, or eye donation.

    • This regulation recognizes that training and skill are required to guide a family through this crucial decision.

If you are looking for staff continued education on eye donation which meets CMS Required Continued Education Standards, please contact Leslie Rose to schedule.
The Lions Medical Eye Bank provides this training to local hospitals free of charge.

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