Providing crossmatched blood to be transfused outside of our organization

[BB1956]

Our Blood Bank has been asked about providing crossmatched blood to be transfused at an oncology office outside of our organization? Does anyone have an experience with this and what are the regulations involved?

[David Saikin]

Just some thoughts on your inquiry: Questions you need to ask: Specimens - who collects; YOUR requirements for adequate labeling (and what happens when it is inadequate). Transportation of specimens and components - who is responsible/time frames; where/how will they store product. Staff training for transfusions/and reactions/how to respond to reactions. NO RETURNS! and make certain that you get to bill the oncology service (and not THEIR patients). You may want transfusion tags returned so that you can document it on patient records.

Actually, I think that once the blood is out of your hands it is not your responsibility . . . AABB has information on off-site transfusions - you could call them (though they might want to sell you a book or 2).

[Malcolm Needs ☆]

YOUR requirements for adequate labeling (and what happens when it is inadequate).

As far as we are concerned (and all of our samples are taken by hospitals, and not by us), if it doesn't meet our labeling policy (unless it is irreplacable - such as a pre-transfusion sample in a casr of a suspected transfusion reaction), it DOESN'T get tested.

Our requirements are in the User Guide and on line, AND they follow the BCSH Guidelines - so there is no excuse.

[BB1956]

Thanks for your input. I do know we will be collecting the samples at our facility however once the crossmatches are performed we do not have control over the transfusion process nor the transfusion reaction follow ups. Transportation is not a very big issue since the facility is across the street from the main hospital, however the actual transfusion is another matter. Needless to say I am not excited about losing any control. As a blood banker I need my control!

[SMW]

There are many, many regulatory issues to consider with such an arrangement. To start with there needs to be an agreement that spells out the responsibility of each facility for each of the steps in the process. You can use the AABB standards as an outline to identify items to be addressed, e.g., ordering practices, sample collection, product receipt and storage, adverse event recognition and reporting, appropriateness of use, blood administration policies, training and competency assessments, compliance with peer-review recommendations and look-back/recall notifications to name a few. The transfusing facility will also need to check for appropriate insurance coverage as well as if local or state licensing is required to provide outpatient transfusions. Remember that whatever items you are responsible for in the agreement, you will also have legal responsibility and liability, e.g. if the agreement states the hospital will review and approve the blood administration policy of the facility then the hospital will also share in the liability of that action.

The agreement should also include how the billing arrangements will be managed and what the fees will be for the products and services. Your agreement should include that you will bill the physician’s office for these products and services and they will then need to bill the patient/their insurance for the products and testing. Keep in mind that transfusions performed in a physician’s office (or skilled nursing facility) in the US are NOT considered HOSPITAL outpatient procedures therefore are generally NOT covered procedures by Medicare or most insurance providers. Since most patients will not be able to afford to pay for these non-covered services, the physicians will be responsible for paying your hospital for these unreimbursed services and they will likely quickly lose interest in continuing to provide in their facility. If this nuance is addressed upfront, the issue may go away before all the time and energy is expended to set-up the processes.

[tbostock]

Also, check your state regs. In NY State, they would need a limited transfusion service permit.

[AMcCord]

We were asked to provide crossmatched blood for an oncology office across the street from us several years ago. They were very eager to get started ($$$$$ signs in their eyes). The practice was informed by hospital management that the agreement with them would require that the practice be billed for the products and services rather than the patients (as has been mentioned by a couple of posters above). They were told how much those charges would be. Then.....we never heard another word about it! Your problem really might just disappear.