NKR Living Donor Evaluation Guidelines

The purpose of the evaluation and consent of the living donor is to maintain the highest degree of safety and transparency for the living donor. As a baseline, the Amsterdam Guidelines and the OPTN standards will be used for donor evaluations. Donor evaluations must be completed before a donor can be activated in the NKR.

The donor center evaluation policies should be followed by the donor center and not be directed by the recipient center since the donor center is responsible for donor care. The receiving center may ask for additional testing to clarify issues related to the quality of the kidney or to ensure there is minimal risk of infectious disease transmission. Requests for additional donor testing should be made immediately upon cross commencement in order to avoid late stage donor declines and failed swaps.

Basic Evaluation:

Complete history and physical
Height, weight, BMI
BP at two different settings on different days
General laboratory to assess:
1. hematologic status,
2. coagulation,
3. electrolytes,
4. fasting lipids and glucose
5. liver status
CXR
ECG
Age appropriate evaluation for cancer
Donor work-ups must be repeated in their entirety, every 12 months, except for CT angio, unless the first CT angio was abnormal

Kidney evaluation:

Urinalysis with microscopy
Urine culture if indicated
24 hour urine for albumin excretion and creatinine clearance
Anatomic Testing for anatomy definition
If a donor GFR reading comes in at or below 85, the center will perform a nuclear medical GFR test to confirm the donor's GFR is > 80
If there is > 10% difference in donor kidney size (between the two kidneys) then the smaller kidney will be offered for donation

Infectious disease screening:

CMV
EBV
HIV 1,2
HBsAg, HBcAB, HBsAB
HCV
RPR
Tuberculosis
Depending upon time of year and location associated risk
1. Strongyloides
2. Trypanosoma cruzi
3. West Nile Virus
4. Toxoplasmosis

Suggested evaluation for donors at risk for metabolic syndrome or diabetes:

Uric acid
HbA1C
Glucose tolerance testing

Stone Disease

If multiple stones or nephrocalcinosis are not evident on CT, an asymptomatic potential donor with history of a single stone may be suitable for kidney donation if they have:
1. No hypercalcuria, hyperuricemia, or metabolic acidosis
2. No cystinuria, or hyperoxaluria
3. No urinary tract infection
An asymptomatic potential donor with a current single stone may be suitable if:
1. The donor meets the criteria shown previously for single stone formers
2. The current stone is less than 1.5 cm in size, or potentially removable during the transplant
Stone formers who should not donate are those with:
1. Nephrocalcinosis on x ray or bilateral stone disease
2. Stone types with high recurrence rates, and are difficult to prevent

Good Samaritan Donor Guidelines

A Good Samaritan Donor is also known as a Non Directed Donor (NDD). They are donors that want to donate to a stranger and may want to start a chain of transplants.

Guidelines for Member Centers working with Non Directed Donors are as follows:

NDD's should be made aware of their donation options. They can either start a chain of transplants or donate to a single recipient on the centers waitlist.
1. If an NDD donates to someone on the center's wait list, the scheduling of the surgery may be easier for the NDD.
2. If an NDD starts a chain of transplants, they will generally help more people get transplants.
3. It often requires a long wait time for "AB" blood type NDD's to start a chain of transplants.
Member Centers should advise NDDs that NKR will provide donor insurance if they start a chain through the NKR.
It is the responsibility of the Member Center to educate the NDD. Member Centers should fully explain the donation process to the donor and should let them know what to expect, before, during and after surgery.
Member Centers should ensure that the NDD can get appropriate time off from work.
Member Centers should determine the NDD's availability for surgery and accurately enter it into the NKR system.
Member Centers should ensure the NDD is updated on a timely basis regarding where they are in the workup process, results of all medical tests, when they are activated in the NKR program and the status of chains that the NDD is facilitating.
The Member Center should inform the NDD that there may be financial support available to assist them in the donation process if they qualify. Eligibility guidelines can be found by clicking on the link to the National Living Donor Assistance Center website.

Medical Board Policies

Match Offer Selection Policy

The NKR shall select match offers based on the following scientific and objective criteria:

When adequate time is available, match offers shall be selected to facilitate the most possible transplants (i.e. longest string of loops and chains) except when a difficult to match pair can be matched.
When time is limited (e.g. NDD has an aggressive donation deadline, compatible pairs are involved in a swap, etc.), match offers with the greatest probability to make it to transplant within the allotted timeframe, shall be selected (e.g. donors pre-selected, donors worked-up, cross matches completed, Member Center surgeons are available, coordinators are available, etc.)
When multiple potential match offers yield equal numbers of transplants, the hardest to match pairs will be prioritized based on pair match power. If pair match power is equal, the longest patient wait times in the NKR system will be given priority.
When multiple CHIPs can end the same chain, children will be given priority. Secondary priority shall be determined by the patient's difficulty to match based on recipient match power.

Policy For Ending Chains

The NKR shall end chains according to the following priorities:

To former NKR Non-Directed Donors (NDDs) in need of a kidney transplant.
To a recipient whose donor has donated and the recipient does not have a kidney such as when an intended donor becomes ill, an out of sequence swap is executed or when advance donation with informed consent takes place.
To CHIP candidates. The center receiving the kidney shall be determined based on forecasted net chains started (FNCS) with the objective of managing FNCS by center within a range of -1 to +3. For the purpose of calculating FNCS, the Member Center that completes the NDD work-up is the center that receives credit for starting a chain.

Children & High PRA (CHIP) Program

The CHIP program helps patients without donors who are either children or are disadvantaged because they are sensitized:

Member Centers may enroll up to 50 candidates in the CHIP program.
CHIP candidates are patients without donors including children (18 or younger) or sensitized adults.
The most likely blood type to find a CHIP match is an "AB" patient, followed by "A" and "B" blood type patients.

Financial Model

Donor Center (providing donor workup and/or nephrectomy) and Recipient Center (performing recipient transplant) desire to provide paired exchange services and agree to the following:

General: In all cases the donor shall not be billed for transplant related medical services including donation evaluation, in-patient stay for donation and post donation complications per Medicare standards. All claims must be submitted to the Recipient Center within 120 days from the last day of service. Acknowledgement is due upon receipt of claims. Claims payment is due as soon as possible and no later than 90 days from the receipt of an accurate claim.
Pre-Transplant Donor Evaluation Services: The Donor Center shall provide pre-transplant donor evaluation services. The Donor Center shall allocate all costs for the donor evaluation to their Medicare cost report. Physicians participating in the donor evaluation shall bill the Donor Center.
Kidney Shipping and Logistics Support: Transportation of the donor organ to the Recipient Center shall be coordinated by the NKR who shall bill the Recipient Center for the costs associated with kidney shipping and logistics support. All OPO costs associated with packaging, labeling and perfusion services shall be billed to the Donor Center. The Donor Center shall pass these OPO costs along to the Recipient Center for payment.
Recipient Inpatient Services: The Recipient Center shall bill for services as customary by submitting claims to the recipient's insurance. The physicians shall bill the recipient's insurance for services rendered.
Donor Complications: Donor complications that arise after the donor's discharge will be billed as follows:
1. If Medicare is primary, then both physician and hospital services shall be billed under the recipient's health insurance claim number to recipient's Medicare.
2. If there is a global arrangement, then both physician and hospital services shall be billed to the Recipient Center.
3. If Medicare is not primary and there is not a global arrangement; then both physician and hospital services shall be billed to the recipient's insurance.
Hospital Donor Nephrectomy: The Donor Center shall bill the Recipient Center for the donor organ recovery cost by providing a copy of their most recently filed Medicare Cost Report, Worksheet D-6, Part I, which documents the cost per day and the appropriate cost to charge ratios along with a worksheet that reduces the Donor Center bill from charges to cost. (sample worksheet)
Physician Donor Nephrectomy: Physicians shall bill the Recipient Center or recipient's insurance for services rendered according to the following:
1. If Medicare is primary, physicians shall bill Medicare utilizing the recipient's Medicare number.
2. If the Recipient Center has a global arrangement, the donor physicians shall bill the Recipient Center at 150% of Medicare participating. Anesthesiology shall bill at $65.29/ASA unit.
3. If Medicare is not primary and if there is not a global arrangement, then the Recipient Center will work with the Donor Center to ensure the donor physicians get paid appropriately.
Regulatory Compliance: This agreement shall serve as written evidence of the required agreement between the Donor Center outlining the scope of services and the process to 1) review the policies and procedures related to: donor evaluation and selection, informed consent, and multidisciplinary donor management throughout the phases of donation; and 2) to monitor and evaluate these services.
1. Additionally, the Donor Center agrees to:
  1. Utilize the NKR standard swap checklists posted on the NKR web site to ensure regulatory compliance
  2. Provide the recipient center with copies of living donor medical records up to the point of donation
  3. Enter swap process issues into the NKR system where appropriate
  4. Immediately communicate to NKR if the Member Center is no longer in good standing
2. Additionally, the Recipient Center agrees to:
  1. Utilize the NKR standard swap checklists posted on the web site to ensure regulatory compliance
  2. Immediately communicate to NKR if the Member Center is no longer in good standing
  3. Enter swap process issues into the NKR system where appropriate

HLA & Cross Matching

Accurate tissue typing and cross matching are critical to the success of our program. To minimize unexpected cross match failures, all member center labs have agreed to:

Accurately enter donor antigens and recipient antibodies including: A, B, DR, Bw, Cw, DQ, DP, DQa, DR-51, DR-52, DR-53
Update recipient antibodies every 90 days or whenever they change
Engage experienced Lab personnel to review all match offers with the goal of achieving a 100% virtual cross match accuracy rate
Report results for the final cross match at least 7 calendar days prior to the scheduled surgery date
If a center reports an unacceptable cross match or virtual cross match failure:
1. email the root cause and corrective action to NKR within 48 hours
2. review the root cause and corrective action on the National Lab Director call
Member Centers are strongly encouraged to cryopreserve donor cells in order to minimize donor blood draws and to be able to react quickly to a false positive results by rerunning the cross test using cryopreserved samples
In order to ensure a streamlined process for cross matching, the following procedures are utilized:
1. Donor center draws and ships donor blood to the recipient center/lab
2. The recipient center is not permitted any contact with donor
3. Donor blood tubes that are shipped to the recipient center include donor name, date of birth, social security number, date specimen drawn and initials of technician drawing the blood
4. Donor center notifies recipient center when to expect blood and provides the package tracking number

**NKR Pick and Ship Kit process is a future offering. Centers shall continue to provide test kits for cross matching until this service is available from NKR.

Shipping Kidneys

Preparation for shipping living donor kidneys:

Donor center will send tubes requested by recipient center for confirmatory donor ABO, initial crossmatch and final crossmatch
Donor center must register the donor and obtain a UNOS donor ID number

Packaging supplies include:

Organ box
Red biohazard bag inside organ box
Clear plastic bag with ice inside a Styrofoam container
Triple barrier packaged kidney (one of which is jar) – all sterile
Labeling attached to kidney bag and outside of box with UNOS ID, ABO and Contents

Kidney box must include the following:

A UNOS label filled out according to UNOS standards on the outside of the box
NKR supplied GPS Device (if required by logistics plan)
NKR supplied Human Organ stickers (if GPS is used) affixed to all 6 sides the box before other labels are applied so that other labels are fully visible
Destination mailing address on the outside of the box (recipient center)
Return address on the outside of the box (donor center)
Two ABO verifications each for donor and recipient (if ABO on crossmatch that may considered as first ABO for donor and recipient)
Crossmatch result of the donor and recipient
Kidney anatomy (aka Renal Data Sheet)
Name and DOB of Recipient
Teidi Donor Registration Page: Please 'print screen' this page (page displays Donor Name, DOB, Donor UNOS ID Number)
Donor blood tubes per recipient center request
Copy of the completed NKR packaging checklist

Shipped Kidneys and GPS Tracking

Donor Centers will receive a GPS device, if required, from NKR approximately 1-5 business days before donor surgery. The device will be charged and requires no activation.
The GPS device must be packed with the kidney. The device is in a water-proof bag which can be left on top of the ice or inserted between the shipping containers.
Coordinators at both the donor and recipient centers will receive periodic alerts to their cell phone and Email, giving the location of the GPS beacon. The device will give a N/A reading once airborne at an altitude of approximately 5,000 feet and higher, it will take approximately 30 minutes after take-off to give the N/A reading.
The coordinator must contact the swap manager immediately if there are any inconsistencies between the GPS readings and logistics plan.
Recipient Centers will receive pre-paid return packaging from NKR for the return of the GPS.
The GPS device must be sent back to NKR no later than one business day after recipient surgery.
It is the responsibility of the coordinators of the recipient center to monitor the GPS device; In addition to periodic alerts the device can be tracked via the internet, instructions on accessing the GPS tracking website are listed below.
1. Contact your NKR liaison to acquire user name and password.
2. Click the following link: http://brickhousesecurity.cp.guardian-mms.com
3. Enter the username and password you were given and click login.
4. On the right side of the screen highlight the device you are looking to locate, they are listed under "Map View", once highlighted click "show selected" button.
5. To view in Google Earth wait for map to open and in top right of map click "Export to Google Earth Format".

Member Center Requirements

General

Centers shall follow all instructions, procedures and policies listed on the NKR web site and included in NKR emails
Centers shall share all relevant information to ensure the best possible outcomes for all swap participants
Centers shall act with the utmost spirit of cooperation to achieve the greatest number of successful transplants across all member centers
Centers shall ensure all information entered into the NKR web site is updated and accurate
Centers shall ensure swap participants are ready to go to surgery once they are activated in the NKR system
Centers shall enter accurate post-transplant data so that research can be conducted on patient outcomes
Centers shall respond to match offers by the match offer deadline which is generally within one business day
When a match offer is accepted, the pair must be immediately deactivated in all other exchange programs, including internal programs
When a match offer is accepted, the recipient's chart must be reviewed for updates and creatinine must be immediately rechecked for predialysis patients
Member Centers shall communicate to all donors that the expected turn-around time for a blood draw request is 1-2 business days.
Donor centers shall notify donors immediately when a blood draw is requested so that donor blood can be shipped overnight to the recipient center within 1-3 business days of the request.
Recipient centers shall report cross match results 1 business day after receipt of donor blood.
If a donor is travelling internationally or expects to be unavailable for blood draws for a period of a week or more, they must be deactivated in the NKR system until they are once again available for a blood draw.
Member Centers must not contact another center's donor, recipient or lab for any purpose.
When cross matching commences, donor medical records shall be immediately shared with the recipient center. If the recipient center needs CTA film, the recipient center will request the film within 24 hours of the commence XM notification
Centers are encouraged to place recipients on hold for deceased donor transplants, once cross matching is successfully completed
Donor pre-operative lab studies (CMP, CBC, UA, C&S) must be completed at least 2 weeks prior to the surgery date to insure donor can proceed
All donors must have two ABO typings, including sub typing where appropriate, before they are activated in the NKR system
Centers shall review potential donors via the Donor Pre-Select function so that the % reviewed is always 95% or higher
Centers shall update the online NKR required fields so that the Data Compliance score is always 99% or higher
Centers shall request an exploratory cross match if there is a reasonable chance of an unacceptable cross match with a potential donor
If a center experiences an issue that is reported in the cross match failure report, they will attend the National Lab Director call to review the issue
Centers shall provide the NKR, upon request, a root cause and corrective action plan within one week of the request
Centers shall conduct antibody screenings every 90 days for sensitized patients enrolled in the NKR and update the avoids appropriately
When a center requests information using the “REQUEST DONOR INFO” feature, the donor center must enter the requested information into the donor profile and notify the requesting center that the requested information has been added to the donor profile within 24 hours of receipt of the request. This will avoid additional future requests by other centers seeking the same donor information.

Coordinators

Primary and backup coordinators must be identified with cell numbers entered on the web site
Primary or backup coordinators must be available 24x7 the day before, and the day of a swap
Primary or backup coordinators at the recipient center are required to monitor the GPS beacon as outlined in the Shipped Kidneys and GPS Tracking section.
Primary or backup coordinators must respond same day (email or phone) during regular business hours
If a pair becomes unavailable to participate in a swap (e.g. recipient sick), that pair must be immediately deactivated in the NKR system
If after the kickoff call the Exchange Coordinator becomes aware of a situation that puts the swap at risk he/she must immediately send an email to Member Services with notification of the situations and that they will contact the Swap Manager.
The Exchange Coordinator will contact the Swap Manager via phone alerting him of the situation. If the Swap Manager cannot be reached via phone the Exchange Coordinator will alert their Center Liaison or any member of the NKR staff.
Primary or backup coordinators must be available for conference calls (e.g. logistic calls, kickoff calls, etc.) with one business day advance notice.

HLA Laboratories

The NKR standard donor antigens and recipient antibodies listed on the NKR web site must be accurately entered for swap participants
Experienced Lab personnel must review all match offers with the goal to achieve 100% virtual cross match accuracy
If a center fails a live or virtual cross match, the root cause and corrective action must presented by the lab director on the National Lab Director call
Every A blood type donor must be sub-typed for A1 and non-A1 status

Administration

Centers shall use the standard financial model posted on the NKR web site to facilitate cost reimbursement between centers
Centers shall not withdraw from an exchange for financial reasons after the cross match tests are successfully completed
Centers shall maintain an updated contract with NKR

Surgeons

Must speak directly with the other surgeon(s) in the swap prior to, and after surgery, to communicate anatomy and other relevant medical issues
Must be ready to schedule the OR for paired exchange surgeries with three weeks advance notice
Must have laparoscopic donor surgical capability

CHIP Program

The CHIP program helps patients without donors who are either children or are disadvantaged because they have high PRAs

NKR member centers that have net chains started > 0 may enroll up to 50 candidates in the CHIP program
Net chains started is the total number of chains that a center starts less the total number of chains a center ends
CHIP candidates must be children (18 or younger) or sensitized adults
The most likely blood types to find a CHIP match are "AB" and "A" blood types

Bridge Donor Guidelines

A bridge donor is any paired donor that donates after their recipient (i.e. friend or family member) receives a kidney transplant in a swap. The bridge donor serves as a "bridge" to the next cluster of transplants in a chain and generally has the ability to be with their friend or family member while they recover from transplant surgery, before they themselves go through kidney donation surgery. Bridge donor guidelines are as follows:

Bridge donors should be prepared to donate between three weeks and three months of their paired recipient's surgery with no significant schedule limitations.
Bridge donors must have no significant medical risks that could prohibit them from donating.
The donor center must be confident that the bridge donor will follow through with donation.
New member centers may want to complete at least three exchange transplants prior to identifying donors as bridge donor candidates.
Member center guidelines for educating and evaluating donors to qualify to be bridge donor candidates should include:
1. Discussions regarding the possibility of being a bridge donor should begin at initial donor evaluation and continue throughout the process.
2. If there is any hesitation with the potential bridging donor, the center should decline offers to bridge the donor and identify the donor accordingly in the NKR donor profile.
3. When asking a donor to bridge, an in-person discussion should occur and include the donor's support person.
4. Member centers must maintain frequent contact with bridge donors.
5. Member centers should advise bridge donor candidates to discuss their commitment to paired exchange with their employer early in the process and again when they become a bridge donor.
6. Member centers must clarify any time constraints with bridge donor candidates and advise donors of the need for immediate notification of any unexpected travel plans and availability during that time for blood draws.
7. Member centers should re-educate donors and reconfirm their availability prior to accepting the donor for a bridge position in a swap.

Help for Medicaid/MediCal Patients

Medicaid and MediCal patients are typically disadvantaged in paired exchange because these insurance programs will generally not pay for out of state physician's fees which will block matches with out of state donors. The best opportunity for Medicaid/MediCal patients is to convert their insurance to Medicare. Below is a conversion guide.

If the patient is on dialysis and has the requisite work history, then Medicare enrollment is granted based on dialysis prior to transplant.
If the patient is not on dialysis and has the requisite work history, then the center should assist the patient with the process for Medicare enrollment at the time of transplant and communicate a billing hold to current payor(s) until Medicare is effective. Additionally, the donor center must agree to hold billing for all professional fees until recipient's Medicare policy goes into effect (a billing hold is better than billing and reimbursing the current payer and then rebilling Medicare).
Member Centers must assist patients with obtaining documentation of Medicare entitlement so that the center can complete a CMS Form 2728 Medical Evidence Report (MER) in order to implement Medicare coverage.
The recipient's Center must provide a completed CMS 2728 Form to the donor center upon match offer acceptance.
Medicare entitlement should always be confirmed prior to transplantation so that the patient is aware of any potential out of pocket expenses, the need to choose RX coverage and other related financial issues.

Click here to review a list of Kidney Transplant Centers.