Chagas' Testing

[ncehall]

We're a small hospital donor center that has not starting testing yet. Most of our blood comes from a large supplier (which does test for Chagas'). Doesn't this create a "standard of care" even though it's not required? Any other centers holding out until it's mandated?

[rcurrie]

No, just because a test is available doesn't create a standard of care. We have a test for parvovirus B19. No US blood center tests for that. We have a test for HPV. No US blood center tests for that. We have a test for HAV. No US blood center tests for that. I could go on, but I think you get the point.

Standard of care can be established by need or by assumption. If you begin testing, then that becomes your standard of care because you assumed the standard. If you can document that the need for the testing is no longer there, you can discontinue the test (Remember ALT testing? Anyone still doing p24 antigen testing?)

Do you NEED to do Chagas' testing? Have there been documented cases of Chagas' disease in your area? (Uh, Mrs. Smith, I know you live in New York City, and I know you have never left the state, but you tested positive for a South American parasite.) The T. Cruzi antibody test is about as specific as the old RPR. I am not jumping on the T. cruzi testing bandwagon. Good luck to anyone who does!

Sure- if AABB mandates it, then I will have to perform the testing. I won't like it, though. Give me an antigen test- please!

BC

[MJDrew]

Unfortunately, Bob, when a blood collection organization decides to implement Chagas' testing nationwide, regardless of the incidence of the disease in the areas it serves, it is viewed by plaintiff attorneys as establishing a standard of care. When the inevitable case of Chagas' happens in an untested unit, can you hear the line of questioning when the director of the center who's not testing takes the stand?? I'm not saying we have to like this--but this inane pursuit of zero risk and our adversarial personal injury legal system make this the way it is.

I have had calls from several of my suppliers who are not testing yet, "feeling out" their hospital customers about their thoughts on this issue. Interestingly, several center directors I've talked with say they're feeling pressure from some hospital customers who have a "mixed" inventory--products from their center and products from the above organization--to start testing so they won't have to deal with "2 levels of safety" or "2 inventories"! This from several directors in areas where incidence of Chagas' on the clinical trial sample runs was zero! So the perception, accurate or not, of increased safety with this testing is already out there. Can you put the genie back in the bottle?

MJ

:cool:

[rcurrie]

Actually, MJ, standards of care are still quite regional. Although my background is in criminal law, my concentration in law school was health law, and malpractice law on top of that. Plaintiff's lawyers do not establish standards of care- standards of care are established based on need and ability. We may need a good B19 test, but there is no standard of care until a good test is developed. We may have a test, but if there is no need for the test, then no standard of care is developed. You can also establish a standard of care personal to your institution by adopting a process or procedure. If you say you are going to do Chagas' testing and fail to do it, then you have dropped below the standard of care. You are still not liable for anything unless that failure causes the plaintiff harm (they developed megacolon, for instance, due to T. cruzi from the blood you failed to test).

I watch the CDC report for my area. There has never been a documented case of Chagas' disease transmission in any county I serve. So, I have no need for T. cruzi testing. I am not the only blood center in my area taking this position. One of the largest blood centers in the south (located in the Dallas area, 150 miles north of me) takes the same position. Give the director a call if you know who I am talking about. He will tell you the same thing I have said.

As far as putting the genie back in the bottle goes, I don't march to anyone else's drum unless there is a gun at my back. I make rational decisions based on what is reasonable. I invoke the Learned Hand risk calculus when making a decision. It has never failed me.

BC

[MJDrew]

Bob--I wish you luck. As usual, everything you say makes sense. But, we do not live in world or work in a profession where sense prevails much of the time. Having just returned from a meeting where it is abundantly clear that we will likely be doing mandated Chagas' testing nationwide (most likely after there is another test platform FDA approved for donor screening), whether there are any cases in our areas, like it or not, this is the atmosphere that I now know prevails. :mad:

And not being an attorney myself, I can't refute the legal definitions of standard of care. Having been (on multiple occasions) on the wrong side of an action for alleged TTD transmissions, from the late 1980s onward, I can tell you that most if not all strict legal definitions of this concept will go out the window when plaintiff attorneys in these cases find out that there is a "difference" in how testing is being done in one part of the country vs. another. Then the "national standard of care", as defined by them, will prevail. If one "national" blood collection firm is performing this testing and others are not, well, those others just aren't meeting the national standard of care. It will have nothing to do with availability or need.

Since King Kessler decreed that our goal shall be zero risk--a goal that is unattainable and unrealistic with current testing methodology--we as an industry have been laboring under this false premise and encouraging the public to think this is possible for blood, when it is not possible in any other life endeavor. While doing this, we (wink, wink, nudge, nudge) assure each other is really not the case. This is our own fault for not speaking up earlier, but we were then on the defensive and apparently felt we needed to kowtow. Big mistake.

MJ

:cool: