The article below is compliments of Cristy's blog, "Living Donors are People Too." If you click on the title of this post, it will take you right to her original post. Kinda makes me wonder what could be down the road for me, and also really scares me that there are STILL no good longitudinal studies on living donors. WHY has this been allowed to happen? Really does make you feel like the general consensus is: "Okay, we got your kidney. Now you can get out of here and leave us alone!" Makes me think even more highly of the medical profession. Read on:
Once again, OPTN has proposed policies up for public comment: http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp
Important to living donors is Number 7, regarding the improvement of living donor followup data. It's a document worth reading because it provides the history and background on living donor followup policies and data submission. Buried within its pages are these little nuggets:
On July 22, 2008, the committee chair gave a presentation to the Membership and Professional Standards Committee (MPSC) on the current status of living donor follow-up. That presentation explained that the Committee’s review of LDF forms revealed a large number of programs reported their donors as “lost to follow‐up” when it is uncertain if reasonable measures were taken to contact donors. Additionally, this committee’s review found that completing two data elements (status and date of status) on the form enabled a center to meet requirements for completion of the form.
We had heard rumors of such things, but this is the first time it's been confirmed that transplant centers could, in effect, return an empty form and receive credit for complying with the living donor follow-up policy.
***
If you recall, I spoke some time ago of the OPTN living donor data task force report that was never publicly released (It's good to know people sometimes). Here's their most damning conclusion, finally out for the world to see:
As currently collected, the OPTN/UNOS data are incomplete beyond the point when the discharge form is submitted (up to 6 weeks post donation, but much earlier for most donors) and therefore useless for research or making conclusions about living donor safety.
***
The living donor follow-up policy was implemented in 2000 (technically late 1999) and signed by the Secretary of State, making it mandatory for program certification and Medicare reimbursement. All similar policies require a 95% compliance rate. The centers have opposed this for a number of reasons, one of which being the number of foreign nationals brought into the country to relinquish an organ, and another being their seemingly instinctual rebellion against anyone holding them to any standard whatsoever.
Anyway, for some reason, this proposed policy says:
Also during it September 2010 meeting, the Committee did endorse developing a policy proposal to establish a threshold for the percentage of living donors that any program can categorize as “lost to follow-up” i.e. donor without a valid status (alive or dead) and accurately reported at required post operative internals. The Committee supported establishing a 10% maximum threshold for categorizing donors as “lost to follow-up”.
I am adept at basic math and 10% 'lost' would equal 90% and not 95%.
***
Now here's my favorite part (And by favorite, I mean the info that is most imperative to the public good). I blogged some time ago regarding the fact that some transplant centers have reported all their living donors as 'lost to follow-up'. The source article was no specific than that, but this proposed policy explanation sheds a bit more light on the matter - see page 6.
For living donors who donated from July 1, 2007 through June 30, 2008, a median 61.8% of one-year living donor follow-up forms indicated whether or not the living kidney donor was alive or dead. The number jumps to 75% of liver donors, and there are a lot fewer of them, both donors and programs.
15 transplant centers had ZERO follow-up on ANY of their living kidney donors during that time period, and only 29 were 100% compliant.
So how many met OPTN's 90% compliance rate? That's a little harder to tell since I only have a bar graph that isn't particularly detailed. However, based on the aforementioned numbers (and a handy tape measure), I'd approximate that 40 transplant centers out of over 200 know whether or not 90% of their living kidney donors are alive or dead one-year after surgery.
Living liver donors fared a bit better. Out of 73 living liver donor transplant programs*, 14 had 100% compliance while only 5 had none. Meanwhile the rest had reported somewhere between 1% and approximately 85%.
Do I need to say this isn't good?
The tragic part of this proposed policy is that it doesn't suggest anything revolutionary. It only requires transplant centers to ensure if someone is breathing, a fact that can be cooborated by cross-checking a living donor's social security number in the Social Security Death Master File (meaning that actual contact with the living donor isn't required to ferret out this information). It does nothing to improve data relating to complications, rehospitalizations, insurance status, psychosocial difficulties, or (shock) long-term ramifications.
Why so wimpy? I'll let the document speak for itself:
The Committee supports the collection of clinical data on living donors for a minimum of two years. However, the Committee understands that there is a lack of consensus on the value of clinical data on living donors during the early post operative period, and consequently anticipates there would be resistance or opposition to new requirements to obtain and report lab results for living donors for up to two years at this time.
Just to recap: Data doesn't exist, yet transplant centers have decided that data has no value. I'd like to know the logic behind that conclusion.
And how many years does the transplant industry collect information on recipients? That's right - ten.
*according to the OPTN membership directory.
Important to living donors is Number 7, regarding the improvement of living donor followup data. It's a document worth reading because it provides the history and background on living donor followup policies and data submission. Buried within its pages are these little nuggets:
On July 22, 2008, the committee chair gave a presentation to the Membership and Professional Standards Committee (MPSC) on the current status of living donor follow-up. That presentation explained that the Committee’s review of LDF forms revealed a large number of programs reported their donors as “lost to follow‐up” when it is uncertain if reasonable measures were taken to contact donors. Additionally, this committee’s review found that completing two data elements (status and date of status) on the form enabled a center to meet requirements for completion of the form.
We had heard rumors of such things, but this is the first time it's been confirmed that transplant centers could, in effect, return an empty form and receive credit for complying with the living donor follow-up policy.
***
If you recall, I spoke some time ago of the OPTN living donor data task force report that was never publicly released (It's good to know people sometimes). Here's their most damning conclusion, finally out for the world to see:
As currently collected, the OPTN/UNOS data are incomplete beyond the point when the discharge form is submitted (up to 6 weeks post donation, but much earlier for most donors) and therefore useless for research or making conclusions about living donor safety.
***
The living donor follow-up policy was implemented in 2000 (technically late 1999) and signed by the Secretary of State, making it mandatory for program certification and Medicare reimbursement. All similar policies require a 95% compliance rate. The centers have opposed this for a number of reasons, one of which being the number of foreign nationals brought into the country to relinquish an organ, and another being their seemingly instinctual rebellion against anyone holding them to any standard whatsoever.
Anyway, for some reason, this proposed policy says:
Also during it September 2010 meeting, the Committee did endorse developing a policy proposal to establish a threshold for the percentage of living donors that any program can categorize as “lost to follow-up” i.e. donor without a valid status (alive or dead) and accurately reported at required post operative internals. The Committee supported establishing a 10% maximum threshold for categorizing donors as “lost to follow-up”.
I am adept at basic math and 10% 'lost' would equal 90% and not 95%.
***
Now here's my favorite part (And by favorite, I mean the info that is most imperative to the public good). I blogged some time ago regarding the fact that some transplant centers have reported all their living donors as 'lost to follow-up'. The source article was no specific than that, but this proposed policy explanation sheds a bit more light on the matter - see page 6.
For living donors who donated from July 1, 2007 through June 30, 2008, a median 61.8% of one-year living donor follow-up forms indicated whether or not the living kidney donor was alive or dead. The number jumps to 75% of liver donors, and there are a lot fewer of them, both donors and programs.
15 transplant centers had ZERO follow-up on ANY of their living kidney donors during that time period, and only 29 were 100% compliant.
So how many met OPTN's 90% compliance rate? That's a little harder to tell since I only have a bar graph that isn't particularly detailed. However, based on the aforementioned numbers (and a handy tape measure), I'd approximate that 40 transplant centers out of over 200 know whether or not 90% of their living kidney donors are alive or dead one-year after surgery.
Living liver donors fared a bit better. Out of 73 living liver donor transplant programs*, 14 had 100% compliance while only 5 had none. Meanwhile the rest had reported somewhere between 1% and approximately 85%.
Do I need to say this isn't good?
The tragic part of this proposed policy is that it doesn't suggest anything revolutionary. It only requires transplant centers to ensure if someone is breathing, a fact that can be cooborated by cross-checking a living donor's social security number in the Social Security Death Master File (meaning that actual contact with the living donor isn't required to ferret out this information). It does nothing to improve data relating to complications, rehospitalizations, insurance status, psychosocial difficulties, or (shock) long-term ramifications.
Why so wimpy? I'll let the document speak for itself:
The Committee supports the collection of clinical data on living donors for a minimum of two years. However, the Committee understands that there is a lack of consensus on the value of clinical data on living donors during the early post operative period, and consequently anticipates there would be resistance or opposition to new requirements to obtain and report lab results for living donors for up to two years at this time.
Just to recap: Data doesn't exist, yet transplant centers have decided that data has no value. I'd like to know the logic behind that conclusion.
And how many years does the transplant industry collect information on recipients? That's right - ten.
*according to the OPTN membership directory.
horrible
ReplyDeleteas you say
the medical industry is miserable
scary, scary stuff.....
Lilly,
ReplyDeleteI have wondered about the long term toll on the living donor. The medical field makes no big deal about or even mentions what can happen to the living donor. It's all about the receipient. Granted if someone needs an organ to life...I get it.
However, what about the living person giving it. What happens to them?
You are the first person I've known who has done this. So I just wonder.
S