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Transplant Centers - National Kidney Registry - Facilitating Living Donor Transplants
 
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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:

  1. Complete history and physical
  2. Height, weight, BMI
  3. BP at two different settings on different days
  4. General laboratory to assess:
    1. hematologic status,
    2. coagulation,
    3. electrolytes,
    4. fasting lipids and glucose
    5. liver status
  5. CXR
  6. ECG
  7. Age appropriate evaluation for cancer
  8. 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:

  1. Urinalysis with microscopy
  2. Urine culture if indicated
  3. 24 hour urine for albumin excretion and creatinine clearance
  4. Anatomic Testing for anatomy definition
  5. 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
  6. 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:

  1. CMV
  2. EBV
  3. HIV 1,2
  4. HBsAg, HBcAB, HBsAB
  5. HCV
  6. RPR
  7. Tuberculosis (Quanti-Feron Gold TB test may not be requested by the recipient center, because of the high false positive rate of this test, unless the donor is high risk for latent TB according to CDC guidelines )
  8. 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:

  1. Uric acid
  2. HbA1C
  3. Glucose tolerance testing

Stone Disease 

  1. 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
  2. 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
  3. 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

Match Offer Communications

  1. When a match offer is received by the Member Center the following communications take place:
    1. The Center first contacts the donor to ensure availability for surgery and no medical changes
    2. If the donor is available, then the center contacts the potential recipient to ensure availability and no medical changes
    3. If both the donor and the recipient are available for surgery and report no medical changes, the center accepts the match offer

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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:

  1. 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.
  2. Member Centers should advise NDDs that NKR will provide donor insurance if they start a chain through the NKR.
  3. 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.
  4. Member Centers should ensure that the NDD can get appropriate time off from work.
  5. Member Centers should determine the NDD's availability for surgery and accurately enter it into the NKR system.
  6. 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.
  7. 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.

 

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Medical Board Policies

Match Offer Selection Policy

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

  1. When adequate time is available, match offers shall be selected to facilitate the most possible transplants except when difficult to match pairs can be matched. Pair matching difficulty shall be measured by the pair match power (PMPc) score.
  2. When time is limited (e.g. NDD has a limited timeframe for donation, 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. In these cases priority shall be given to factors such as:
    1. Donor has already been accepted in the pre-select function.
    2. Cross match has already been completed and is acceptable.
    3. Fast track center (can go from offer to transplant in 3 business days).
  3. When multiple potential match offers yield equal numbers of transplants, in addition to the considerations outlined in #1 & #2 above, prioritization shall be given to:
    1. Patients with the longest wait times in the NKR system.
    2. Children.
  4. When multiple CHIPs can end the same chain, prioritization shall be given to:
    1. Children > 80% NKR cPRA.
    2. Adults > 80% NKR cPRA.
    3. Children < 80% NKR cPRA.
    4. Adults < 80% NKR cPRA.
Policy For Ending Chains

The NKR shall end chains according to the following priorities:

  1. To former NKR Non-Directed Donors (NDDs) in need of a kidney transplant.
  2. 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.
  3. 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:

  1. Member Centers may enroll up to 50 candidates in the CHIP program.
  2. CHIP candidates are patients without donors including children (18 or younger) or sensitized adults.
  3. The most likely blood type to find a CHIP match is an "AB" patient, followed by "A" and "B" blood type patients.
Policy for photographing damaged or abnormal kidneys:
  1. Once a kidney is removed from a donor, if there are no abnormalities, digital pictures of the kidney are encouraged, but not required.
  2. If there is any damage to the kidney or any other abnormalities not already communicated to the recipient surgeon, the donor surgeon is required to email or text pictures of the kidney to the recipient surgeon within 30 minutes after kidney removal.
  3. If the kidney is declined by the receiving center, the receiving center must take and store pictures of the kidney that include any abnormalities. Upon receipt of the returned kidney, the donor center must take and store pictures of the kidney that include any abnormalities.
Policy for managing real-time swap failures:
  1. A real-time swap failure occurs when a swap fails after one or more donor surgeries have begun.
  2. When a swap fails in real-time, NKR shall first attempt to cancel or reschedule the swap.
  3. If any of the donor surgeries cannot be aborted, then the NKR Member Centers shall proceed with the swap and the NKR shall immediately work to end a chain (utilizing a bridge donor or a non-directed donor) to the patient in the failed swap that did not receive a kidney.
  4. The center caring for the patient that did not get a kidney must remove all restrictive preferences and accept all viable donors via the donor pre-select function unless the center determines that it is in the patient's best interest (e.g. pre-emptive transplant) to wait longer by declining viable potential donors in order to get a better match.
  5. If the patient that did not get a kidney is hard to match (e.g. NKR cPRA > 80%), the NKR may not be able to find a compatible donor for that patient. This risk must be disclosed in the Member Center's informed consent documentation that is signed by the patient and the donor.
  6. In the calculation of "net chains started", the donor center is accountable for the chain break.
  7. The donor center shall cover all costs related to the donor surgery and donor care.
  8. If the real-time swap failure was caused by the recipient center's decline of a kidney:
    1. The kidney will be immediately shipped back to the donor center using the fastest method of transportation available, to minimize cold ischemic time, for transplant into a wait-listed patient.
    2. If the kidney is utilized by the donor center and functions adequately:
      1. The center declining the kidney will be responsible for all shipping and logistics costs (estimated at between $10,000 - $100,000) and;
      2. The recipient surgeon will be required to review the case with the Surgical Committee.
    3. If the kidney is not utilized by the donor center or does not function adequately:
      1. The donor center will be responsible for all shipping and logistics costs (estimated at between $10,000 - $100,000) and;
      2. The donor surgeon will be required to review the case with the Surgical Committee.
    4. If there is ambiguity regarding the adequate function of the declined kidney, the Surgical Committee will make a determination based on medical data provided to the committee by the transplanting center one month after the transplant.

 

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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:

  1. Accurately enter donor antigens and recipient antibodies including: A, B, DR, Bw, Cw, DQ, DP, DQa, DR-51, DR-52, DR-53
  2. Update recipient antibodies every 90 days or whenever they change
  3. Engage experienced Lab personnel to review all match offers with the goal of achieving a 100% virtual cross match accuracy rate
  4. Report results for the final cross match at least 7 calendar days prior to the scheduled surgery date
  5. 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
  6. 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
  7. 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

 

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Shipping Kidneys 

Preparation for shipping living donor kidneys:

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

Packaging supplies include:

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

Kidney box must include the following:

  1. A UNOS label filled out according to UNOS standards on the outside of the box
  2. NKR supplied GPS Device (if required by logistics plan)
  3. 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
  4. Destination mailing address on the outside of the box (recipient center)
  5. Return address on the outside of the box (donor center)
  6. Two ABO verifications each for donor and recipient (if ABO on crossmatch that may considered as first ABO for donor and recipient)
  7. Crossmatch result of the donor and recipient
  8. Kidney anatomy (aka Renal Data Sheet)
  9. Name and DOB of Recipient
  10. Teidi Donor Registration Page: Please 'print screen' this page (page displays Donor Name, DOB, Donor UNOS ID Number)
  11. Donor blood tubes per recipient center request
  12. Copy of the completed NKR packaging checklist
  13. Kidney must be 100% covered in ice

Shipped Kidneys and GPS Tracking

  1. 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.
  2. 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.
  3. 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.
  4. The coordinator must contact the swap manager immediately if there are any inconsistencies between the GPS readings and logistics plan.
  5. Recipient Centers will receive pre-paid return packaging from NKR for the return of the GPS.
  6. The GPS device must be sent back to NKR no later than one business day after recipient surgery.
  7. 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".

Unusual or Abnormal Situations

  1. Donor center must take a photo of the kidney, packaging or box if there is anything that is unusual or abnormal
  2. Recipient center must take a photo of the kidney, packaging or box if there is anything that is unusual or abnormal

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Member Center Requirements 

    Routine

  1. NKR Service Contract is current
  2. Donor Center Agreement is current
  3. Recipient Center Agreement is current
  4. Member Center's Earliest Organ Pickup Time is 11:00 or earlier
  5. Member Center's Latest Organ Pickup Time is 18:00 or later
  6. Member Center's 30 Day Moving Average Preselect % is at or above 95%
  7. Member Center's Data Compliance is at or above 99%
  8. All Routine Member Center Requirements are assessed at month end
  9. General

  10. Centers shall follow all instructions, procedures and policies listed on the NKR web site and included in NKR emails
  11. Centers shall share all relevant information to ensure the best possible outcomes for all swap participants
  12. Centers shall act with the utmost spirit of cooperation to achieve the greatest number of successful transplants across all member centers
  13. Centers shall ensure all information entered into the NKR web site is updated and accurate
  14. Centers shall ensure swap participants are ready to go to surgery once they are activated in the NKR system
  15. Centers shall enter accurate post-transplant data so that research can be conducted on patient outcomes
  16. Centers shall respond to match offers by the match offer deadline which is generally within one business day
  17. When a match offer is accepted, the pair must be immediately deactivated in all other exchange programs, including internal programs
  18. When a match offer is accepted, the recipient's chart must be reviewed for updates and creatinine must be immediately rechecked for predialysis patients
  19. Member Centers shall communicate to all donors that the expected turn-around time for a blood draw request is 1-2 business days.
  20. 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.
  21. Recipient centers shall report cross match results 1 business day after receipt of donor blood.
  22. 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.
  23. Member Centers must not contact another center's donor, recipient or lab for any purpose.
  24. 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
  25. Centers are encouraged to place recipients on hold for deceased donor transplants, once cross matching is successfully completed
  26. 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
  27. All donors must have two ABO typings, including sub typing where appropriate, before they are activated in the NKR system
  28. Centers shall request an exploratory cross match if there is a reasonable chance of an unacceptable cross match with a potential donor
  29. When an exploratory cross match is requested, donor medical records shall be immediately shared with the recipient center. The recipient center's decision to accept the donor must be based on a review of donor records along with an acceptable exploratory cross match
  30. 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
  31. Centers shall provide the NKR, upon request, a root cause and corrective action plan within one business day of the request
  32. Centers shall conduct antibody screenings every 90 days for sensitized patients enrolled in the NKR and update the avoids appropriately
  33. When a pair is scheduled for transplant, a wellness check on both the donor and recipient is recommended within 24 hours of scheduled pre-op. The minimal requirement for the wellness check is a phone call to the donor and recipient confirming they are healthy and ready to move forward with the scheduled surgery.
  34. 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.
  35. Coordinators

  36. Primary and backup coordinators must be identified with cell numbers entered on the web site
  37. Primary or backup coordinators must be available 24x7 the day before, and the day of a swap
  38. 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.
  39. Primary or backup coordinators must respond same day (email or phone) during regular business hours
  40. If a pair becomes unavailable to participate in a swap (e.g. recipient sick), that pair must be immediately deactivated in the NKR system
  41. 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.
  42. 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.
  43. Primary or backup coordinators must be available for conference calls (e.g. logistic calls, kickoff calls, etc.) with one business day advance notice.
  44. HLA Laboratories

  45. The NKR standard donor antigens and recipient antibodies listed on the NKR web site must be accurately entered for swap participants
  46. Experienced Lab personnel must review all match offers with the goal to achieve 100% virtual cross match accuracy
  47. 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
  48. Every A blood type donor must be sub-typed for A1 and non-A1 status
  49. Administration

  50. Centers shall use the standard financial model posted on the NKR web site to facilitate cost reimbursement between centers
  51. Centers shall not withdraw from an exchange for financial reasons after the cross match tests are successfully completed
  52. Surgeons

  53. The donor surgeon must call the recipient surgeon within an hour after completion of the donor nephrectomy. If the donor surgery went well, there are no concerns, and the recipient surgeon is not available, a voice mail will suffice. If there are concerns, a second attempt should be made to reach the recipient surgeon. If the second attempt fails, then the recipient center coordinator should be contacted to pass along the information and the surgeons can speak when both are available.
  54. Must be ready to schedule the OR for paired exchange surgeries with three weeks advance notice
  55. Must have laparoscopic donor surgical capability

 

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CHIP Program 

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

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

 

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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:

  1. Bridge donors should be prepared to donate between three weeks and three months of their paired recipient's surgery with no significant schedule limitations.
  2. Bridge donors must have no significant medical risks that could prohibit them from donating.
  3. The donor center must be confident that the bridge donor will follow through with donation.
  4. New member centers may want to complete at least three exchange transplants prior to identifying donors as bridge donor candidates.
  5. 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.

 

 

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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.

  1. If the patient is on dialysis and has the requisite work history, then Medicare enrollment is granted based on dialysis prior to transplant.
  2. 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).
  3. 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.
  4. The recipient's Center must provide a completed CMS 2728 Form to the donor center upon match offer acceptance.
  5. 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.

 

 

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National Kidney Registry -- Facilitating Living Donor Exchanges