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The Written Croner Protocol: What Is It and Do You Really Need One?

The eye bank sent out template protocols to all coroners in Colorado and Wyoming in February, 2015, but only 15 of 87 counties have signed it or negotiated necessary changes for their county. Here are some common questions that may help clarify the purpose of the protocols and the consequences of not having one.

Do I need a written protocol?

Yes. The Uniform Anatomical Gift Act (UAGA) in both Colorado and Wyoming requires the coroner to enter into a written agreement with the eye bank to outline how cases under the coroner’s jurisdiction are handled when donation of eye tissues is an option. In Colorado, the District Attorney must also sign. It is an opportunity for us to come to a mutual agreement on how best to work together in your county. Operating without a written protocol is operating outside of what the law requires of you.

 Must I sign the protocol the eye bank sent me?

No, but you still need a written agreement to be compliant with the law. The protocol we sent is simply a template that outlines the basics of what the law requires of coroners to maximize donations for transplant.

If you want us to call a different number after hours, then it should be in the protocol. If you want only red-topped tubes for vitreous fluid, it should go in the protocol. If your staff needs two hours to interact with the pathologist, it should go in the protocol. If you want the eye bank to stop and consult with you if it finds an abnormality in the eye, then it should be in your protocol (Remember, no one looks at more eyes than an eye bank recovery technician!). The protocol simply sets expectations for both the eye bank and the coroner for exactly how it should go when there is an eye donor under your jurisdiction.

So, I can put anything in the protocol that works for my office?

Yes, as long as it is not contrary to the UAGA and is agreeable to the eye bank.

For example, a coroner MAY NOT include a policy that no donations will be allowed when the death is a suspected homicide. The Act only allows denial of the donation if the specific tissue’s removal would interfere with determining a cause and manner of death. That requires individual consideration of the forensic value of the tissue. This kind of blanket refusal of donation is contrary to the coroner's obligation to consult with, and cooperate with, procurement organizations under the Act to maximize donations.

However, a coroner MAY put a clause that, in certain cases like suspected shaken baby syndrome or gunshot wounds to the head, requires the eye bank to take photos prior to recovery or requires a visual inspection by the coroner or investigator. That visual inspection, however, would have to happen within the time periods that would allow recovery of the cornea because the UAGA requires that.

Why does the eye bank need a protocol separate from the organ or tissue bank?

The Rocky Mountain Lions Eye Bank is a separate organization from other recovery agencies. According to the UAGA, the eye bank is also the legal custodian of the gift of eye tissues. As such, only the eye bank can represent the interests of maximizing the opportunity for cornea transplants, as the Act requires. Only the eye bank has the necessary expertise to work with the coroner toward any decision on the timing of a cornea recovery and the impact on transplant suitability. Likewise, the eye bank is aware of its caseloads at the time of the call and is uniquely positioned to juggle cases to accommodate a coroner's time constraints or logistical needs to move a body. We can cause a recovery to happen faster because we control our resources.  

No county coroner would delegate his or her responsibility to investigate a death to another agency. In the same way, the eye bank cannot delegate its responsibility as the custodian of the gift of eye donation.

Why can’t I have just one phone call for all types of donations?

We’ve tried it and it simply does not work. In fact, it can jeopardize the suitability of a cornea for transplant. The national standard for the time between death and the preservation of corneas is eight hours. However, a recent study by our technical department found that the time between death and the preservation of the corneas averaged 11.5 hours when the tissue bank made a single call to the coroner for release of all donated tissues. When the eye bank called on its own behalf, the time decreased to 5.5 hours. While medical standards allow us to go as far out as 18 hours from the time of death in certain cases, it becomes increasingly more difficult to place the corneas with a suitable recipient as that time lengthens. This has a direct impact on transplant rates of donated corneas. Corneal tissue is unlike any other donated tissues: the delicate endothelial cells on the back of the cornea are crucial to a successful transplant and have a limited viability time with much tighter time constraints.

In nearly all cases, the decision to release corneas for recovery is often an easier decision to make. The transparent cornea has very little forensic value and the eye bank’s thorough eye exam and vitreous collection are enough for most pathologists. After all, no one will look at more eyes and be able to spot abnormalities than an eye bank recovery technician!

In many cases under a “one call” system, there was a tendency for coroners to consider all donations together when they were presented together. This does not necessarily fulfill the law’s requirement that each tissue be considered separately, taking into account its impact on determining a cause and manner of death.

What happens if I don’t sign a written protocol?

First, things won’t run smoothly in your county. With nearly seventy percent of Colorado residents and 60 percent of Wyoming residents registered as donors, you WILL have donors under your jurisdiction. You have to deal with it.

Secondly, you would not be compliant with the law. In Colorado, the UAGA has a provision outlining the process when a written protocol is not in place. This, however, does not relieve the coroner of the responsibility to enter into an agreement. This is the law and we are bound by it. In Colorado, the law mandates several things in the absence of a protocol, to include:

  • If asked by the recovery agency, the coroner must view the body either at the hospital or recovery location prior to making a decision whether or not to allow the procurement organization to recover and must comply within a time period compatible with the preservation and purposes of the tissue.
  • When a determination to delay the recovery of the eye or tissues is made, every effort possible shall be made by the coroner to complete the collection of evidence or autopsy in a timely manner compatible with the preservation of the eye or tissues for the purpose of transplantation or therapy. That is eight hours in the case of an eye donor.

A written protocol is simply in the best interests of your office because it can be customized to your county and its processes and resources.   

In Wyoming, the Act does not specify procedures when a protocol is not signed. The law simply requires coroners to enter into written agreements. According to legal experts, a variety of remedies are available for non-compliance with the law. These range from civil suits to intervention from the Attorney General or a court order compelling the coroner to comply with the law or face contempt of court charges.