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New trend raises liability questions about storage, transport, security
Storing umbilical cord blood for future use is a relatively uncommon practice, but publicity from the general media and from several cord blood storage companies is increasing the chance that parents will come to your facility and expect this service. If they do, will your staff know how to comply without taking on significant liability?
Because most delivery units do not encounter the request at all, and it’s rare even in the busy "baby factories," it is likely that your organization does not have a formal policy for handling such requests. More than likely, your staff just do their best to comply with parents’ requests to preserve the blood and package it for transport to a storage unit. But now that more parents are hearing about the practice, it may be time to develop a formal policy to address potential liability for facilities delivering babies.
For the moment, the liability risks from stored umbilical cord blood appear minor but not altogether negligible, says Greig Coates, MD, JD, an attorney with Mithoff and Jacks law firm in Austin, TX. He pre viously practiced medicine and now is a malpractice attorney.
"A lot of the risk with this issue is theoretical, but if you have all the wrong factors at all the wrong times, I can see how this practice could cause problems for risk managers," he says. "I’d place it on the level of the many theoretical problems that can occur at your hospital but probably never will, and you still have policies and procedures in place just in case. The problem is that this practice has sort of snuck up on some of us in this profession, and we have it going on without any policies to cover it."
Umbilical cord blood is stored as a sort of insurance in case the newborn gets sick in the future with a disease that can be combated with his or her own stem cells. The blood is taken from the placenta and umbilical cord and contains the stem cells, the building blocks of the blood and immune systems, which are found mostly in the bone marrow in adults. Recent advances in stem cell research have revealed treatment options for patients suffering from a range of blood-related disorders. (See p. 44 for more on how stem cells from umbilical cord blood can be used.)
Several private companies around the country are promoting the option of stored umbilical cord blood to prospective parents and providing collection kits for them to take to the hospital at delivery time. The storage companies may take on substantial liability risk once the blood is in their hands, but it is not so clear how much risk the delivery hospital has before custody is transferred.
The good news, Coates says, is that it’s un likely the hospital would be held liable if, years later, the cord blood is found to be unusable because it was handled or stored improperly.
"There are so many things that can go wrong from the time of collection to the time of thawing decades later, and it would be virtually impossible to show that something happening in your facility was the cause," he says. "Most problems are going to be related to storage, and that’s not your responsibility."
Fortunately, your staff are in possession of cord blood just briefly, Coates says. As soon as they release it for delivery to the storage facility, your organization’s liability risks should end right there, Coates says. That analysis is echoed by Jeannie Sedwick, ARM, risk manager with The Medical Protective Co. in Cary, NC, and a former president of the American Society for Healthcare Risk Management. She says you should focus on transferring as much potential liability to the storage facility as soon as possible.
"If a third-party contractor is going to take this material and be responsible for caring for it properly, then it’s best to get it out of your hands and into theirs as soon as possible. Don’t hold onto it at all, if possible," Sedwick says. "Once you turn it over to them with all the proper paperwork and sign-offs showing that it was done correctly, I don’t think you have to worry about what happens from that point forward. Whatever happens, it can’t be blamed on your staff."
Both Sedwick and Coates recommend establishing policies and procedures for responding to cord blood requests. (See p. 43 for additional information.)
The main liability questions seem to center on who would take the blame if a specimen turned out to be unusable, but there are other thorny issues to consider. For instance, is it wise for your staff to hand over cord blood to the parents when that blood could be evidence in a future lawsuit? Sedwick and Coates both say it does seem odd to send parents home with such valuable evidence, but on the other hand, the blood might not prove useful in a malpractice case no matter who has custody of it.
"Clinically, there isn’t going to be a whole lot you can do with it later, after it’s frozen and thawed," Coates says. "You can’t freeze the pH level. Any evidence that is going to show up in a blood-gas analysis just isn’t going to be there when a really intrepid attorney goes to dig it up years down the road."
It’s unlikely the plaintiff’s attorney will spring evidence on you that wouldn’t have been available if the blood had not been stored. Coates does point out, however, one related problem that could be serious: If the doctor orders a blood-gas analysis, but your overzealous staff provide the cord blood to the parents without noticing the order, the specimen may be released and the remainder of it destroyed before you obtain that critical evidence.
Only a small amount of blood is needed for the blood-gas analysis, so there is no conflict between doing the test and preserving the cord blood. Just make sure your staff doesn’t overlook the testing order before officially handing over custody of the blood, Coates says.
Another odd aspect of cord blood storage is that your delivery staff will be handing over a potentially valuable specimen to lay parents, grandparents, or friends. Storage companies provide parents with collection kits and instruct them to deliver the specimen by mail, courier, or in person.
Proper care is important for preservation of the blood, and knowing that, some clinical staff could be uneasy about letting grandpa walk out with it. But Coates and Sedwick say there is no real alternative because you shouldn’t take on the liability burden by mailing the specimen yourself.
Coates also points out that risk managers should look at all the potential liability risks as only the current risks with cord blood storage. These risks could grow, and new risks could emerge, as cord blood storage becomes more common and stem cells prove more useful in treatment.
"If, down the road, we get into gene therapy such that the stem cells could be put to much more use, the risks could be bigger than we anticipate now given the current use of the cells," he says. "The perceived small risk now could blossom with the advent of medical technology advances."