Informed consent about the HLA match

[sloaner1982]

I would like to ask a question about living kidney donation regarding transplant centers responsibility to the living donor.
I have been told two conflicting things regarding what the transplant center is required/expected to tell a potential donor.
The first is that the living donor should be told all testing results of the testing they do to be considered an organ donor. I am referring specifically to the blood test, crossmatch test and also the results of the HLA test.

Now, on the other hand I am told that it is the industry standard NOT to tell the potential living kidney donor the results of the HLA matching test.

I would think that any potential donor would want to know the results of All these tests- not just  the blood type and the crossmatch.  I know that I feel I should know ALL this information before consenting to further testing to take place.
What is your position on this disclosure to the potential living donor so that they can make an informed decision.

[Fr Pat]

Dear "Sloaner..."
     I don't know the answer to your question, but I wonder if giving you all the information from the MATCHING tests would involve giving you some information from the recipient's part of the test? I don't imagine that they could give you any information about the potential recipient's test unless he/she gave permission, due to confidentiality regulations.
      Fr. Pat

[Clark]

Sounds like you've found a transplant center, or just individuals, who haven't fully understood that the landscape for donor consent has changed. There are some challenging privacy considerations that some donor-recipient candidates have had to deal with in the past, like parent-child pairs that turned out not to be genetically related. "Tissue mismatch" used to be a favorite "out" for donor candidates declining to proceed, too.

Now that there are explicit guidelines and Independent Donor Advocates, no center should hesitate to be explicit about their information policy in advance, at any time throughout the workup period, or any time after donation. If they can't, or won't, provide you a written policy explaining why the level of HLA match should be withheld from you, or if they do, and you disagree, I recommend you find another transplant center and please report this one to the OPTN/UNOS Patient Report Line at 888-894-6361. Be sure to explain why you've changed transplant centers to your new IDA. (S)He'll want to understand up front.

Remember, your emotional affect is one of the criteria they're judging about your suitability to be a donor, so deal with people considerately and professionally even when they appear to be unjustifiably stonewalling you. They're wrong to do so, but that's their problem. Report it and move on. Best wishes.

[Clark]

A further thought, you may get "It doesn't matter in the modern era of anti-rejection medications." There is good data suggesting that the level of mismatch from 1-6 has a relatively small disparity in estimated graft survival compared to the difference between 0 and 1. It is not zero, though. You may also be told that a surgeon or the candidate approval committee does not consider it appropriate to decide on this basis. Discuss it candidly with your IDA. HLA matching levels, especially 0 mismatch, are still a driving deciding match criterion in most aspects of deceased, paired, and directed donation. Why shouldn't you use it, or at least know your level of mismatch proposed?

[JustAPyper]

Doesn't HIPPA disallow the disclosure of patient (potential donor) information?  I thought that was the reason we never got any details about other people's cross-match results other than good or bad.

[Michael]

Here's a possible explanation for the conflicting information:

> There are effectively no "national standards" in the US for living donation procedures, including informed consent. I say "effectively" because there are Medicare standards in the 2007 Final Rule governing certification of Medicare-eligible transplant programs, but they aren't enforced. The UNOS Living Donation Committee has put together recommendations, but they also are simply recommendations. They are not enforceable--there is no consequence for not following the recommendations. With that said, anecdotal evidence suggests most if not all transplant centers inform the potential donor of the HLA matching level. In the 10+ years we've had a message board, I don't know of anyone who didn't know the HLA match. That doesn't mean there aren't people who didn't know. It's just in my unscientific experience, everyone seems to know, suggesting that the policy of most centers is to disclose. (Yes, I was informed.)

> The Health Insurance Portability and Accountability Act (HIPAA) contains restrictions on the ability to disclose personally identifiable health information. This is the law and it is enforced. I'm guessing that the person you talked to who said the "national standard" is not to disclose was referring to this law. Do you know if that's the case?

Even so, the disclosure of an HLA matching level isn't a disclosure of the potential recipient's health status. Also, personal health information can be shared when its used in the care of the patient, and it can also be shared with friends and family members unless the patient says otherwise. I'm not a lawyer, but it seems like HLA matching information would not be subject to HIPAA. But your friend may believe otherwise.

HIPAA notwithstanding, I would like to see full disclosure to a potential living donor of information that would help the donor understand the likelihood of success. I believe understanding whether the donation has a good chance of working or is an act of desperation would be useful to the donor in deciding whether to take on the risk to their own health. The information could include any behavioral issues (e.g., alcoholism of a potential liver recipient) or comorbidities (e.g., advanced heart disease) that could indirectly result failure or the recipient's death. There can be circumstances where the donor's right to know conflicts with the recipient's right to privacy. I'm admittedly biased, but I think the ethical answer favors the donor since they are the one who is taking on the additional risk.

I've seen several attempts over the years to get to a standard for informed consent--and a couple of suggested lists have been created--but there is absolutely no enforcement. Consequently, every transplant center has its own policies.

What's your position?

[Donna Luebke]

In 2000, the Live Donor (Kidney) Consensus Conference set forth recommendations to those concerned about the well-being of the live organ donor.  The attendees concluded that the live organ donor be competent, willing to donate, free of coercion, medically and psychosocially suitable, fully informed of the risks and benefits; and fully informed of the risks, benefits, and alternative treatments available to the recipient.

So here we are almost in 2014 and still the donor is not fully informed of the risks--and I would think that the HLA match comes under the risks, benefits and alternative treatments available to the recipient.  HIPPA is used too much in defense and interferes with providing care.  I requested in writing the antigen match for my donation to my sister.  I was told was a perfect match but wanted this in writing.  Full disclosure should be part of consent to donate and for the intended candidate to accept this organ offer.  The National Kidney Registry has a section on their website "Why the Match Matters."  NKR does not go to transplant unless is a high quality match--centers should do the same.  If not a good enough match for a long term outcome then discuss a swap.  Not fair to the donor if the kidney fails early on (and we know for experience and the mental health articles how this impacts donors.)  Not fair to the intended candidate to go to surgery with a poor match.  Am sure would rather wait on the list then get a transplant that fails early on.  Any kidney will do is a terrible philosophy but then they have a 'willing donor' which to some, is all they need.  Going to transplant with a poor quality match--only dooms the recipient to be highly sensitized making it more difficult to get transplanted in the future--and wasted a kidney plus knowingly has put a donor's life at risk for a futile transplant.   

OPTN policies are voluntary but enforceable--by CMS.  To get Medicare dollars transplant hospitals have to comply with OPTN policy.  Failure to do so not only impacts the transplant program but the entire hospital.  Anyone who works at a transplant hospital should know this and be concerned.  CMS needs to move toward national standards and stop relying on the OPTN.  The OPTN has been in existence since 1986 and done nothing to improve donor safety or donor standards.  Reading minutes of the LDC is like reliving the past--spinning their wheels and nothing gets done with any teeth. More seems to happen when donors go to the Feds or the media. 

Michael--you are correct about the 2007 CMS Rules and Regs. I would like CMS to hold back Medicare $$ --this would show some teeth to these Regs. 

[sherri]

I requested my HLA typing to be sent to me. The copy of the report was sent to me with my brother, the recipient's HLA blacked out and my other sister's HLA who also tested blacked out. I believe I asked my sister to have a copy sent to her so we could compare. So it isn't that difficult to deduce someone else's antigens. I knew I was a 6/6 match with my brother so that told me basically his typing.

It is difficult to keep HLA typing confidential. I work with stem cell transplant patients and in order for the transplant to be successful the matches need to be identical or maybe 1 antigen mismatched so siblings will always know their tissue typing if they request their HLA report. There is an understanding that if we are looking for a full matched donor each one will know the other's tissue typing.

Perhaps stricter protocols, not guidelines need to be set up to ensure that potential donors have enough information to make an informed choice about deciding whether to give their kidney to a particular recipient and the recipient should also have the information about the donor so they can decide if they want to accept a kidney from a particular donor. More consent forms to allow transfer of information would be needed and it should protect both the recipient and the donor.

[lawphi]

I am torn.  I was able to receive my HLA report with my husband's with my health care POA.

As a recipient's wife through a bridge paired exchange, I wouldn't want a donor to have the power to skip over my husband  who rightfully  "won" her kidney through a matching program simply because she found something not to be desirable about him.  Also, what happens if the original recipient isn't able to receive the kidney after the operation has reached the point of no return?  My center had back up recipients in case that happened to my husband and my kidney.

[sloaner1982]

 This is regarding a directed donation where the "potential" living donor asks the transplant center to test her/him to see "IF" she/he is a "MATCH" with a specific person that he/she identifies to be tested for.
I have a surgeon saying that the donor does NOT NEED to know the HLA test results and another transplant professional saying that it is the NATIONAL STANDARD of the industry NOT to tell the donor these results. And this is with a transplant that was/is FUNDED by Medicare.
This is so wrong. I don't know how they can get away with this and it seems that NO ONE has the guts to challenge these people.
Attorneys run from it because they don't understand the truth and because it will be too hard to fight in court. This leaves the transplant industry with no one to answer to. They make their own rules and it does not matter who gets hurt in the end. Being FULLY INFORMED is the donors right and it should be LAW, not just a recommendation. Doctors take an oath to "do no harm" I can not see how withholding the HLA test results from the potential living donor so that she/he can be fully informed is even ethical at all. It is my understanding that the greater the HLA match the greater the chances of a successful long-term outcome.  If there is anything that could decrease the chances of a successful long-term outcome, the donor has the right to know this information. How is telling the potential living donor the results of their own HLA test a hippa violation in the first place? From what I know, it is the Donor's name at the top of the test report. At least it was in my case.  Is there anything a living donor can do to hold transplant centers and the team who does not fully disclose all risks,
accountable?

[sherri]

i have my HLA typing report from the lab. My recipient's information is blacked out. This is part of my medical record and by law I am entitled to it. You can call the UNOS or OPTN hotline to file a complaint. You can also speak to a patient advocate at the hospital. It would seem to me that you can ask what antigen match you are to the recipient, meaning 0/6 to a possible 6/6. divulging the exact HLA typing is not meaningful to most people but certainly within your right as a patient to receive. The recipient should also be aware of the level of the antigen matching so they can make an informed decision if they would like to pursue that donor or perhaps look for a better matched donor.

I currently work as a transplant nurse coordinator for stem cell transplants (patients with leukemia, lymphoma or myeloma) and I interact with potential donors both related and unrelated (new career after becoming a living donor). We disclose the results of the HLA typing to the potential donor, then usually ask if we have permission to discuss this with the recipient. The matching process for stem cell is a little different than for solid organ in terms of the degree of matching. But certainly I would give any patient asking for a copy of their HLA typing. As a nurse I am obligated to provide that according to the patient's bill of rights.

I would definitely take this higher up. It is also a good indicator of the hospital's attitude towards patient autonomy and informed consent . You may want to seek out another hospital.

Good luck in the process.


Sherri

[lawphi]

The problem is you do any make certain rules for certain transplants. It has to be the same across the board. It can't be informed consent for one group  to formulate their decision and not for another.

The major problem is that legal requirements for informed consent is for a patient receiving a nephrectomy, regardless of whether the kidney has cancer or is being donated.  The only difference is what the medical benefit is to that particular patient.

[sloaner1982]

I have directly contacted UNOS and personally spoke with a woman from patient services. I was wanting an answer on where UNOS stands regarding the living donors right to informed consent specifically beginning with informing the potential donor the results of the match testing as I believe that is the first thing that needs to be known in order to decide about going forward with more testing or not.
I stand firm that the potential donor needs to know and has the right to know the results of the blood type test, HLA match, and the crossmatch with the intended recipient. The donor is not informed if any of these results are WITH HELD and not disclosed to them.
Anyway, this woman would not answer my question, only referring me to the UNOS living donor policy page.
Seems like no one wants to give a final answer and this gives centers free reign to make up their own rules.
I have also contacted the civil rights government office regarding hippa laws and wanting an answer about the potential living donors right to know the test results of the match. Blood type, HLA match, and crossmatch.  I will keep you all informed if and when I get any answers from the powers that rule.

[Clark]

The staff person at UNOS, as an employee of the contractor serving as the OPTN, can't give you more information than the policy because there isn't more information than the policy. The compromises made to get the policy through the board of directors, due to the explicit prodding of the HRSA observers about compliance with the HHS Secretary's directives, included transplant center based discretion about the content of their informed consent protocol, as well as their testing and information sharing policies. They were only required to establish written policies and maintain evidence of compliance with their own policies for potential audit. The initial audit findings suggested widespread failure to create adequate, complete policy, to adequately document adherence, and widespread failure to actually adhere to their own policies. This led to the additional guidelines, now requirements, just adopted by the board in November 2013. As these come into effect, and audit findings demonstrate results, the question is, how will the board respond to non-compliance? Will there be warnings? Disciplinary actions? Suspensions of living donor programs? Loss of CMS funding access for the entire medical center affilaited with the transplant center? We are watching, and so are the HRSA observers. This doesn't help we who have already taken the leap of faith required by less than adequate informed consent protocols. It may improve the experience of those setting foot on the path to donation now.