New Living Kidney Donor Program Requirements: Standardizing Patient Care

Which policy numbers are being changed?

12.10 (ii) is now 12.4 Independent Donor Advocates;

12.10 (iii) is now 12.3.3 Psychosocial Evaluation of the Living Kidney Donor, and 12.3.4 Medical Evaluation of the Living Kidney Donor;

12.10 (iv) is now 12.2 Informed Consent of Living Kidney Donors, and 12.2.1 Living Kidney Donor Evaluation Consent

Is there a place that we can get a concise list of the new policy changes/requirements that were briefly discussed in the webcast (i.e. lab requirements, cancer screening, etc.)?

View Policy 14, Living Donation now.

Does this policy apply to liver donors?

Policies 12.2, 12.2.1, 12.3.3, 12.3.4, 12.4, 12.4.1, 12.7.10.1, 12.8.3 and 12.8.3.1 do not apply to

living liver donors. Separate policy proposals that cover living liver donor consent, evaluation and follow-up are scheduled for public comment in the fall of 2013. If the proposals are supported during public comment, they could be considered by the OPTN Board of Directors in June 2014 and, if approved, policies for living liver donors could take effect as soon as September 2014.

The change to Policy 7.2, however, does apply to LDF forms for both kidney and liver donors. All LDFs will be due to the OPTN 60 days after form generation, which reflects an increase from the previous deadline of 30 days after form generation.

Will DEQ surveyors audit the recovery hospital or the recipient’s transplant hospital for the living donor compliance? Should the recovery hospital or the recipient’s transplant hospital register the donor in UNetsm? Is the recovery hospital or the recipient’s transplant hospital responsible for all the living donor follow-up?

The recovery hospital is responsible for all living donor forms, and the recovery hospital should enter the donor into UNetsm. (They may need to provide the donor ID to the recipient center so that the recipient center can remove the recipient from the waitlist with the correct donor ID).

The recovery center (where the recovery surgery is actually performed) is responsible for meeting all living kidney donor policy requirements for that living donor.

Therefore, the OPTN contractor will evaluate compliance with the living kidney donor policies during surveys of recovery hospitals.

Informed Consent, Psychosocial & Medical Evaluations & IDAs 12.2, 12.2.1, 12.3.3, 12.3.4, 12.4 & 12.4.1

Informed Consent, Psychosocial & Medical Evaluations & IDAs 12.2, 12.2.1, 12.3.3, 12.3.4, 12.4 & 12.4.1

How does DEQ monitor evaluation of living donors who aren’t local? Can testing requirements be completed somewhere other than the recovery hospital?

The kidney recovery procedure must occur at an OPTN member recovery hospital approved to perform living kidney recoveries. OPTN member recovery hospitals must follow OPTN living donor policies with all of their living kidney donors, regardless of the donor’s place of residence. Documentation validating that all requirements have been met must be available in the donor chart at the recovery hospital.

Policies 12.3.1 and 12.3.2 specify that the recovery hospital must complete the two required ABO typings and subtypings. For elements of policy 12.3.4 addressing required testing, the policy requires that the recovery hospital must asses or evaluate the testing, but does not specify that the recovery hospital complete the testing. Therefore, test procedures (other than ABO typings and subtypings) may be performed elsewhere, with the results sent to the recovery hospital. In these cases, the recovery hospital and a physician or surgeon experienced in living donation must perform the evaluation of the test results and are responsible for documenting this evaluation in the donor chart. A copy of the test results must be maintained in the donor chart.

If a hospital screens for high risk behavior with the initial health screen intake, do they still need to screen with the psychosocial?

Yes, the assessment for high risk behaviors (as defined by the USPHS) is now required in both policy 12.3.3 Psychosocial Evaluation of the Living Kidney Donor and 12.3.4(D) Medical Evaluation of the Living Kidney Donor.

What does Policy 12.3.4(L) mean when it says our center must exclude donors with “diagnosable psychiatric conditions requiring treatment before donation?”

The recovery hospital must document in the living donor’s chart that an evaluation was completed and an assessment statement was made concerning the presence (or absence) of diagnosable psychiatric condition. If a psychiatric condition is documented, then the hospital (the person doing the evaluation) is expected to document their assessment indicating whether or not treatment is required prior to proceeding to donation.

During surveys, DEQ would expect to find statements addressing each of the following questions in the notes of the psychiatrist, psychologist or clinical social worker:

1. Is there a diagnosable psychiatric condition?

2. Does the condition require treatment?

3. Is donation prohibited by the condition at this time? (Or is the patient cleared to donate?)

DEQ site surveyors will look to all three components in their reviews of documentation. Members may be found in potential violation of this policy if a donor proceeded to donation while the answers to all three questions were “yes”. However, UNOS does not read the policy language as excluding patients who are stable on their current treatment if the psychosocial assessment makes a clear statement that the individual is cleared for donation.

If a donor has a history of suicidality, but not a current suicidality, does policy 12.3.4(L) require the hospital to exclude the donor?

DEQ will look for documentation stating a clinical impression of current suicidality. If present, and the patient proceeds to donation, the member could be cited for potential policy violation.

Policy 12.2(F) requires hospitals to provide donors with information about "all CMS outcome requirements not being met" by the recipient transplant program. How do we get this information?

A list of the CMS outcome requirements can be found in CMS Regulation 482.82(c)(3). Most of the information to determine if a specific hospital is meeting those outcome requirements is available in the program specific SRTR reports.

Is there a typo in policy 12.2(l)? Does it really mean that the donor consent has to include the disclosure that infectious diseases and malignancies discovered during follow-up must be disclosed to the donor?

The new policy does require recovery hospitals to document that they informed potential donors that “any infectious disease or malignancy pertinent to acute recipient care discovered during the potential donor’s first two years of post-operative follow-up care will be disclosed to the donor.” This subsection is focused on requiring the hospital to let the donor know that their results will be shared. It is for the benefit of the donor to let them know that not only will other people be told, but the donor will also be told if something shows up in the tests.

The new policy for the Psychosocial Evaluation of the Living Donor (policy 12.3.3) requires that "the psychosocial evaluation must be completed by a psychiatrist, psychologist, and/or clinical social worker". Currently, our psychosocial evaluations have been performed by both LMSW (Licensed Master Social Worker) and LCSW (Licensed Clinical Social Worker). Can an LMSW can still perform the psychosocial evaluation of a living donor?

The term “clinical” in this policy element does not require that the social worker hold an LCSW versus a LMSW. DEQ site surveyors may ask to review the hospital’s protocols to confirm that the actual individual performing the evaluation is listed as qualified to complete the living donor psychosocial evaluation.

The new policy 12.3.4(J) requires testing for Hepatitis B Surface Antibody. Does this test have to meet the FDA approval for donor screening?

No, policy 12.3.4(J) doesn’t require that the tests in this section be FDA-approved or cleared. DEQ surveyors will only be looking for evidence that a test was performed. They will not require anything more specific than what the language dictates.

Reporting Requirements 7.2, 12.8.3 & 12.8.3.1

Reporting Requirements 7.2, 12.8.3 & 12.8.3.1

How will a donor be counted if we can collect only partial data on them?

A living donor must have complete and timely data on all fields required by the policy in order to count as having follow-up for compliance purposes. When calculating compliance with thresholds, both serum creatinine and urine protein will be required for a donor to count as having complete lab data. Similarly, all donor status/clinical information fields will be required for a donor to be considered as having complete donor status/clinical information.

How will compliance with follow-up thresholds be measured? Is it with completion of certain data elements? Is it with % of patients not seen? Is it with % of patients lost to follow-up?

The percentages are calculated in the following ways: Lab Data:

Living kidney donors with both timely serum creatinine and urine protein All living kidney donors who donated during the time frame

Donor Status and Clinical Information:

Living kidney donors with all timely status and clinical info All living kidney donors who donated during the time frame

What happens if we don’t hit the thresholds required in the follow-up policy?

The MPSC will review information on transplant hospitals that do not meet the minimum thresholds for submission of form data. The MPSC could issue a Notice of Uncontested Violation or consider other actions. The MPSC would consider the specific circumstances of any center under review. (Only the Secretary of HHS can close a program for policy violations.)

My center currently sees kidney donors at 3 months and reports that follow-up on the six month LDF, so to be clear, would three month follow-up data on a 6 month follow-up form be a policy violation?

Yes, the new donor follow-up policy requires that donor data be collected within 60 days of the 6 month, one-year, and two-year reporting periods. Only data collected between 4 and 8 months post- donation should be reported on the 6 month LDF form.

Can we get information on how our program is doing before the OPTN starts monitoring this policy?

Yes, a center can obtain detailed data on the status of its living donor follow-up at any time.

Living Kidney Donor Follow-up Standard Reports can be requested through the data request form on the OPTN website.

What other resources are available?

Kidney Independent Living Donor Advocacy Training Documentation Manual - NATCO has developed a manual for the Kidney Independent Living Donor Advocate; the goal of the manual is to provide the tools necessary to help the Independent Living Donor Advocate/Independent Living Donor Advocate Team work with the potential donor and be certain that all necessary information has been imparted to the potential donor. NATCO recognizes that at each transplant center many different individuals may fulfill this role. In preparing this manual, NATCO solicited input from many social workers, physicians, nurses and clergy who currently work as donor advocates in their institutions. While there are too many to name individually, we want to assure the reader that all points of view were considered.

Regarding Policy 12.3.1 (ABO Identification) and 12.3.2 (ABO subtype Identification), are living donor recovery hospitals required to complete two separate and additional blood type tests or can the blood type tests required under these policies be performed by another facility or lab?

This policy was clarified by the Living Donor Committee and approved by the Executive Committee on May 1, 2013. The policy was clarified to note that “living donor recovery hospitals must ensure blood type testing of each living donor is performed on two separate occasions prior to donation.” The living donor recovery center is not required to perform two separate and additional blood type tests”. This policy language took effect on June 3, 2013. Surveyors will continue to ensure that each hospital documents results of 2 ABO typings performed prior to donation. Note, that policy 12.8.1 requires that the hospital use source documents from both the initial and the second determination ABO typings in order to enter the ABO data on the Living Donor Feedback Form. In order to assure compliance with this policy, surveyors will request those source documents for review.

What year was the 6 month, 1 year, & 2 year follow up for living kidney donors implemented?

The OPTN began collecting follow-up data (at 6 months and 1 years post-donation) on living donors in 1999. The OPTN added the 2-year LDF form for donors who donated after implementation of the form in March 2008. The new policy for follow-up reporting for living kidney donors (12-8.3.1) went into effect on February 1, 2013 and applies only to living kidney donors who donated on or after that date.

Are donors allowed to be given information about medical conditions that the recipient may have that may influence the outcome of the transplant?

Members must follow federal requirements (e.g., HIPAA) as regards release of protected patient health information. HIPAA rules do apply to the release of transplant candidate information to a potential donor.

Published 7/12/2013