Altering blood or blood products

[connies]

Does anyone know if pooling platelets, pooling cryo or splitting a unit of blood can be done in hospitals that is only CAP accredited? Do we need to register with FDA to alter products?

[Cliff]

Do you already perform compatibility testing? If so, then you'd need to be registered. If not and these are new processes that you'd be adding to your operations you would need to be registered for that too.

Here is a link to the appropriate CFR: http://a257.g.akamaitech.net/7/257/2422/12feb20041500/edocket.access.gpo.gov/cfr_2004/aprqtr/21cfr607.3.htm

[John C. Staley]

Cliff, I hate to disagree with you but crossmatching does not require FDA registration. As long as you do not "modify" any blood products you do no have to register with the FDA. Pooling, Packing, Thawing, Aliquoting and Dividing are not modifying. Irradiating, and Washing are modifying.(I'm sure there are others but I can't think of them now.) The reason I know this is that our corporation is the only one with the distinction of having transfusion services under a consent decree (long story). We are not allowed to modify blood products but we can do Pooling, Packing, Thawing, Aliquoting and Dividing. We do all other pretransfusion testing and are not registered.

Hope this helps.

John

[Cliff]

Cliff, I hate to disagree with you but crossmatching does not require FDA registration. As long as you do not "modify" any blood products you do no have to register with the FDA. Pooling, Packing, Thawing, Aliquoting and Dividing are not modifying. Irradiating, and Washing are modifying.(I'm sure there are others but I can't think of them now.) The reason I know this is that our corporation is the only one with the distinction of having transfusion services under a consent decree (long story). We are not allowed to modify blood products but we can do Pooling, Packing, Thawing, Aliquoting and Dividing. We do all other pretransfusion testing and are not registered.

Hope this helps.

John

Thanks for the clarification John. We are a rather large transfusion service so the idea of not being registered is rather foreign to me. I read this statement from the 2004 CFR:

(d) Manufacture means the collection, preparation, processing or

compatibility testing by chemical, physical, biological, or other

procedures of any blood product which meets the definition of a drug as

defined in section 201(g) of the act, and including manipulation,

sampling, testing, or control procedures applied to the final product or

to any part of the process. The term includes packaging, labeling,

repackaging or otherwise changing the container, wrapper, or labeling of

any blood product package in furtherance of the distribution of the

blood product from the original place of manufacture to the person who

makes final delivery or sale to the ultimate consumer.

[QDeb]

I am part of a 6-hospital system - Transfusion Services only. Only one of our facilities needs to be registered because they perform washing. The others do not need to be registered and they pool products. When in doubt call FDA and ask - that's what we did.

[MJDrew]

"Processing" is the key word in the CFR, and is less confusing than using "manufacturing" or "modifying", or "manipulating"...etc.

Hospital blood banks are defined as entities that routinely collect or process whole blood or blood components. Collection may be via apheresis or products may be prepared from whole blood. Processing includes: freezing, deglyerolizing, washing, irradiating, rejuvenating, or leukoreducing red blood cells. These facilities must register with FDA.

Transfusion services are defined as hospital laboratories that solely prepare red cells or recovered plasma, pool platelets and/or cryoprecipitated AHF, or as facilities that issue bedside leukoreduction filters. These facilities are not required to register with FDA (21 CFR 607.65[f]). Emergency collection at these facilities does not require registration.

Currently, the only reason my facility is FDA registered is for irradiation. We used to perform freezing, deglycerolizing, washing, and rejuvenating, but no longer perform these functions. If there was a way to offload the irradiation to a local blood center for the cost and TAT that I get doing it here, I would do it in a heartbeat, and lose the registration. But this is not to be!

[bmarotto]

I hear you MJ! What I never figured out is if you do even one of the activities that require registration with the FDA they come in and inspect EVERYTHING you do. One time an FDA inspector tried to cite us because the phlebotomist performing a therapeutic phlebotomy (we discard this blood immediately after collection) did not document on the worksheet that he billed the patient for the procedure. Our medical director had a fit and demanded to know what not billing a therapeutic phlebotomy had to do with the safety, quality, or efficacy of the blood products provided to our patients. The inspector was actually trembling at this point and removed this finding from the summary report.

Alas, we wash, deglyc, and irradiate so we must be registered.

[MJDrew]

B, I would have been livid as well if the incident you describe had happened in my blood bank/donor area. I really have no clue why the CSOs believe their agency has jurisdiction over products that are not intended for transfusion. Of course, with the error reporting (BPD) system, we can also take it on the chin for specimen labelling errors and others occurring outside the blood bank! Figure that one out! Thank heavens we no longer collect auto or directed donors!!!

The last couple of inspections we've had have been heavily weighted toward a microscopic assessment of transfusion reactions (probably to see if we're missing reporting any TR deaths or serious reactions, such as TRALI), which is TOTALLY outside the realm of these folks' expertise. At least it is when they start trying to tell me that 2 physicians deciding a reported complication was not transfusion-related is not sufficient. At one point I actually indicated to the inspector that I didn't realize her position with FDA required a medical license! That stopped that line of questioning very quickly!

MJ

[bmarotto]

MJ...we had a TRALI death about 2 years ago. We reported it to the FDA as well as to the supplier of the implicated product. FDA asked our state DPH to send someone out to investigate because they were busy. The state inspector is a former MT lab manager and totally understood there was nothing we could have done to prevent it. She actually commented on how quickly nursing recognized the reaction and how the blood bank initiated the appropriate investigation and notification procedures. Two weeks later, an FDA inspector showed up totally unaware that the FDA requested the state to investigate. I have to say the tone of the FDA investigation was that we were guilty until proven innocent. It shouldn't be that way.

[MJDrew]

Yeah, the "blame game" sort of inspection really makes you want to bend over backward to report these deaths & complications, doesn't it?? The agency needs to take a cue from kids--if you know you're going to get "punished", the natural human tendency is to hide the evidence!

MJ

[Julie]

Yeah, the "blame game" sort of inspection really makes you want to bend over backward to report these deaths & complications, doesn't it?? The agency needs to take a cue from kids--if you know you're going to get "punished", the natural human tendency is to hide the evidence!

MJ

I find it difficult to comprehend you actually "hide evidence". Ideally, we must document all mistakes and errors...how else do we learn and, thereby improve our services?