OMB No. 0915-0157; Expiration Date: XX/XX/20XX
If a candidate receives a transplant or dies while awaiting a transplant, then the registering transplant hospitals must remove the candidate from the hospital’s organ waiting lists and notify the OPTN Contractor within 24 hours of the event.
If the candidate has multiple-registrations for the same organ, each transplant hospital where the candidate is registered must meet these requirements.
When a user removes a
candidate due to transplant, the necessary information needed to
complete the recipient-side of feedback is entered at that time. As
soon as removal information has been entered for reason of
transplant, the Transplant Recipient Registration and Recipient
Histocompatibility records will be created in TIEDI®.
If
the transplant recipient re-registers for another organ to replace a
transplanted organ, then waiting time will begin as of the date and
time the candidate re-qualifies. The waiting time from the previous
registration may be added to the new registration according to
policy.
Note: The time stamp on the candidate's status history is based on Eastern Time, not the center's time zone (if different from ET).
Transplant Center: Verify the transplant center name, and that the provider number is the 6-character Medicare identification number of the hospital where the transplant candidate is listed.
24 Hour Contact Phone Number: Verify the transplant center phone number.
SSN: Verify the transplant candidate's social security number.
Note: SSN cannot:
Contain 00 in the 4th and 5th place (e.g. XXX-00-XXXX is invalid)
Contain 0000 in the last 4 places (e.g. XXX-XX-0000 is invalid)
Begin with 666
Name: Verify the candidate’s name.
Birth sex: Indicate if the patient is Male or Female. Report patient sex (male or female), based on biologic and physiologic traits at birth. This is a required field.
DOB: Verify the candidate's date of birth. This is a required field.
ABO: Verify the candidate’s ABO.
State of Permanent Residence: Tthe full name of the state where the candidate's home is located.
Permanent Zip Code: The 5-digit U.S. postal zip code for the address where the candidate's home is located. Note: Make corrections to an incorrect permanent zip code on the Transplant Candidate Registration (TCR) form in TIEDI®. This field cannot be updated from the active list.
Ethnicity/Race: Select as appropriate to indicate the candidate's ethnicity/race.
American Indian or Alaska Native: Select for candidates who are of North, South, Central or American descent (i.e. American Indian, Eskimo, Aleutian, Alaska Indian). If the candidate belongs to the primary category, but does not belong to any of the subcategories listed, select American Indian or Alaska Native: Other. If unknown, select American Indian or Alaska Native: Not Specified/Unknown.
Asian: Select for candidates who are of Asian descent (i.e. Asian Indian/Indian Sub-Continent, Chinese, Filipino, Japanese, Korean and Vietnamese). If the candidate belongs to the primary category, but does not belong to any of the subcategories listed, select Asian: Other. If unknown, select Asian: Not Specified/Unknown.
Black or African American: Select for candidates of African descent (i.e. African American, African (Continental), West Indian or Haitian). If the candidate belongs to the primary category, but does not belong to any of the subcategories listed, select Black or African American: Other. If unknown, select Black or African American: Not Specified/Unknown.
Hispanic/Latino: Select for candidates who are of Central or South American descent (i.e. Mexican, Puerto Rican (Mainland), Puerto Rican (Island) or Cuban). If the candidate belongs to the primary category, but does not belong to any of the subcategories listed, select Hispanic/Latino: Other. If unknown, select Hispanic/Latino: Not Specified/Unknown.
Native Hawaiian or Other Pacific Islander: Select for candidates who are descendants of the Native Hawaiian, Guamanian or Chamorro, or Samoan peoples. If the candidate belongs to the primary category, but does not belong to any of the subcategories listed, select Native Hawaiian or Other Pacific Islander: Other. If unknown, select Native Hawaiian or Other Pacific Islander: Not Specified/Unknown.
White: Select for candidates who are of European Descent, Arab, Middle Eastern or North African (non-Black). If the candidate belongs to the primary category, but does not belong to any of the subcategories listed, select White: Other. If unknown, select White: Not Specified/Unknown.
If Removal Code 4 Deceased Donor TX, removed by transplanting center, 15 Living Donor TX, removed by transplanting center or 21 Patient died during TX procedure is selected, the Removal Due to Transplantation section must be completed.
Donor ID: Enter the donor’s ID. This is a required field.
Donor OPO: Select the OPO from the drop-down menu. This field is not required for Removal code 15.
Donor Organ Received: Displays the organ for which the candidate was listed.
Organ Type: Select the type of organ received. This is a required field.
Transplant Date: Enter the transplant date as the date of the beginning of the first anastomosis in the format MM/DD/YYYY. When you remove a waiting list registration, the transplant date you report should be the first anastomosis date of the organ(s) associated with that registration. For example, if you remove a kidney/pancreas registration from the waiting list, you can only report one transplant date (anastomosis date of whichever organ was first anastomosed). If your recipient receives a kidney and a liver, you should report the kidney transplant date as the anastomosis date of the kidney, and report the liver transplant date as the anastomosis date of the liver. This is a required field. The transplant date is determined by the start of the organ anastomosis during transplant or the start of the islet infusion. Organ transplants include solid organ transplants and islet infusions. An organ transplant procedure is complete when any of the following occurs:
The chest or abdominal cavity is closed and the final skin stitch or staple is applied.
The transplant recipient leaves the operating room, even if the chest or abdominal cavity cannot be closed.
The islet infusion is complete
Were extra vessels used in the transplant procedure: If a Removal Code of 4 Deceased Donor TX, removed by transplanting center or 15 Living Donor TX, removed by transplanting center is selected, indicate if extra vessels (vascular allografts) were used in the transplant procedure. If the use of vessels is not known at the time of removal, select UNK. Select unknown to obtain this information at a later time.
Vessel Donor ID: If extra vessels were used in the transplant procedure, enter the Donor ID of the vessel donor. Transplant hospitals must report extra vessels dispositions to the OPTN within 7 days of use or destruction. Vessel disposition data can continue to be reported at the time of removal for a transplant or it can be reported in TIEDI®.
Note: If the extra vessels used in a transplant procedure are procured from a tissue processing organization, they are not reported in UNet℠. If extra vessels from multiple donors were used in the transplant, please report these donors in TIEDI® or contact the UNet Help Desk for assistance.
Did the candidate receive any other organ transplant at this time: Check one or more boxes to indicate any other organs that the candidate received during the entire transplant surgery.
Select all that apply:
Heart
Lung
Liver
Bone Marrow
Pancreas Islet
Pancreas
Intestine
Recipient Histocompatibility Laboratory: From the Recipient Histocompatibility Laboratory field, select the name of the histocompatibility laboratory that performed the candidate/donor cross-match. If a cross-match test was not performed, select the name of the histocompatibility laboratory that performed the most recent HLA typing of the candidate.
If a candidate was not typed, select Not Typed from the Recipient Histocompatibility Lab field, and a Recipient Histocompatibility form will not be created.
Note: When a kidney, kidney-pancreas, pancreas, or pancreas islets candidate is removed from the Waitlist, the option of Not Typed is not available.
Did the patient go to the operating room and receive anesthesia for transplant prior to death?: If the patient received anesthesia prior to death, select Yes. If not, select No. If Yes, then indicate if anastomosis was initiated.
Was anastomosis initiated?: If anastomosis was initiated prior to death, select Yes. If not, select No. If Yes, then indicate if death occurred before the cavity was closed.
Did the death occur before the cavity was closed and after the final stitch and/or staple was applied?: If death occurred before the cavity was closed, select Yes. If not, select No.
Date of Death: Enter the date of death in the format MM/DD/YYYY.
Cause of Death: Select the cause of death from the drop-down list.
Other Specify: Enter the cause of death if not listed in the Cause of Death drop-down.
Specify the Reason: Enter the reason for removal.
Country: Select the country in which the transplant occurred. If the candidate has notified the program that he or she will receive a transplant in another country, thereby eliminating the need for transplant in the United States, please select the country in which it will occur. If country is unknown please select "Unknown" from the list. This is a required field.
If you are removing a kidney-pancreas candidate, the Special Kidney-Pancreas Removal Option section displays. Select
Remove Kidney-Pancreas registration
Remove Kidney-Pancreas registration and relist for isolated kidney
Remove Kidney-Pancreas registration and relist for isolated pancreas
If Remove Kidney-Pancreas registration and relist for isolated kidney is selected, enter the following information
Medical Urgency Status: Select the kidney candidate's status from the drop-down list. If Active - Medically urgent (5) is selected a warning message displays indicating that candidate cannot be relisted for an isolated kidney because required kidney information is missing. To relist this candidate for an isolated kidney, you must first edit the kidney-pancreas registration and select "Isolated Kidney", complete required kidney data, and click Save. You may then proceed with removal and relisting.
If you are unable to provide the required kidney data at this time, you may proceed with the removal and relisting but are required to relist the candidate at an inactive status. When the required kidney data becomes available, you will be able to update the record and change the registration to an active status.
If Temporarily Inactive is selected, select an Inactive reason.
If Remove Kidney-Pancreas registration and relist for isolated pancreas is selected, enter the following information
Has candidate had a prior kidney transplant: Indicate if the candidate has had a prior kidney transplant. If the patient is being removed for the reason of a kidney transplant, please indicate “Yes” to this question.
If yes, is the kidney graft still functioning: Indicate if the candidate's kidney graft is still functioning.
If functioning, enter the donor's antigens: If the candidate's kidney graft is still functioning, select the appropriate donor HLA information from the drop-down lists.
A
A
B
B
BW4
BW6
C
C
DR
DR
DR51
DR51
DR52
DR52
DR53
DR53
DQB1
DQB1
DQA1
DQA1
DPB1
DPB1
DPA1
DPA1
If you are removing a kidney-pancreas candidate, the Special Kidney-Pancreas Removal Option section displays. Select
Remove Kidney-Pancreas registration
Remove Kidney-Pancreas registration and relist for isolated kidney
Remove Kidney-Pancreas registration and relist for isolated pancreas
If Remove Kidney-Pancreas registration and relist for isolated kidney is selected, enter the following information
Medical Urgency Status: Select the kidney candidate's status from the drop-down list. If Active - Medically urgent (5) is selected a warning message displays indicating that candidate cannot be relisted for an isolated kidney because required kidney information is missing. To relist this candidate for an isolated kidney, you must first edit the kidney-pancreas registration and select "Isolated Kidney", complete required kidney data, and click Save. You may then proceed with removal and relisting.
If you are unable to provide the required kidney data at this time, you may proceed with the removal and relisting but are required to relist the candidate at an inactive status. When the required kidney data becomes available, you will be able to update the record and change the registration to an active status.
If Temporarily Inactive is selected, select an Inactive reason.
If Remove Kidney-Pancreas registration and relist for isolated pancreas is selected, enter the following information
Has candidate had a prior kidney transplant: Indicate if the candidate has had a prior kidney transplant. If the patient is being removed for the reason of a kidney transplant, please indicate “Yes” to this question.
If yes, is the kidney graft still functioning: Indicate if the candidate's kidney graft is still functioning.
If functioning, enter the donor's antigens: If the candidate's kidney graft is still functioning, select the appropriate donor HLA information from the drop-down lists.
A
A
B
B
BW4
BW6
C
C
DR
DR
DR51
DR51
DR52
DR52
DR53
DR53
DQB1
DQB1
DQA1
DQA1
DPB1
DPB1
Total Infusions With This Transplant: Displays the total number of infusions the pancreas islets candidate has received to date.
Note: An islet infusion is defined as an infusion from a single deceased donor. If a recipient receives islets from multiple donors simultaneously, each donor's islets must be counted as a separate infusion.
Re-List Candidate?: If the candidate is to be automatically re-listed (added to Waitlist), select Yes. The wait time will continue to accrue from the time the candidate was initially added. If not, select No. This field is required for pancreas islets candidates that are removed with code 4-Deceased Donor TX, removed by transplanting center.
Total Infusions With This Transplant: Displays the total number of infusions the pancreas islets candidate has received to date.
Note: An islet infusion is defined as an infusion from a single deceased donor. If a recipient receives islets from multiple donors simultaneously, each donor's islets must be counted as a separate infusion.
Re-List Candidate?: If the candidate is to be automatically re-listed (added to Waitlist), select Yes. The wait time will continue to accrue from the time the candidate was initially added. If not, select No. This field is required for pancreas islets candidates that are removed with code 4-Deceased Donor TX, removed by transplanting center.
To successfully remove a liver candidate for any of the removal code options, enter the appropriate information in the MELD/PELD Data Collection section. When a liver candidate is removed from the Waitlist, the lab dates CANNOT be earlier than the last lab dates entered on the candidate's record and the lab dates CANNOT be after the transplant date if the candidate is being removed for reason of transplant.
Copy most recent MELD/PELD labs from above: Copy most recent MELD/PELD labs from above: Select the check box to certify that the lab results are the most recent MELD/PELD labs obtained for the liver patient prior to transplant or removal. The values from the existing fields will fill into the boxes.
Serum Creatinine:
Test Date
Had dialysis twice, or 24 hours of CVVHD, within a week prior to the serum creatinine test?
Serum Sodium
Test Date
Encephalopathy
Ascites
Bilirubin (mg/dL)
Value
Albumin (g/dL)
Value
INR
Value
Bilirubin (mg/dL) (PBC/PSC/Other Cholestatic)
Copy most recent MELD/PELD labs from above: Select the check box to certify that the lab results are the most recent MELD/PELD labs obtained for the liver patient prior to transplant or removal. The values from the existing fields will fill into the boxes.
Serum Creatinine
Test Date
Had dialysis twice, or 24 hours of CVVHD, within a week prior to the serum creatinine test?
Serum Sodium
Test Date
Encephalopathy
Ascites
Bilirubin (mg/dL)
Value
Albumin (g/dL)
Value
INR
Value
Bilirubin (mg/dL) (PBC/PSC/Other Cholestatic)
Has the candidate ever had any of the following devices? (TAH, IABP, VA ECMO, VV ECMO, Dischargeable VAD, Non-Dischargeable VAD, Percutaneous Device): Indicate if the candidate has had a device implanted by selecting Yes or No. This field is required.
Note: If the candidate was removed from the waiting list for a transplant, only devices implanted prior to transplant should be reported.
Device Type: Select the device type from the drop-down list. This field is required.
TAH
IABP
VA ECMO
VV ECMO
Percutaneous Device
Dischargeable VAD
Non-Dischargeable VAD
Device Brand: Select the Device Brand from the drop-down list. This field is required. If you select Other, Specify enter the device brand in the Specify field.
TAH: If you select Other, Specify enter the device brand in the Specify field.
AbioCor
SynCardia CardioWest
Other, Specify
Percutaneous Device: If you select Other, Specify enter the device brand in the Specify field.
Biomedicus
Cardiac Assist Tandem Heart
Impella Recover 2.5
Impella Recover 5.0
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
PediMag (Thoratec/Levitronix)
Cardiac Assist Protek Duo
Impella CP
Impella RP
Other Specify
Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Evaheart
Heartmate II
HeartMate III
Heartsaver VAD
Heartware HVAD
Jarvik 2000
ReliantHeartAssist 5
ReliantHeart aVAD
Worldheart Levacor
Other, Specify
Non-Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Abiomed AB5000
Abiomed BVS 5000
Berlin Heart EXCOR
Biomedicus
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
Medos
PediMag (Thoratec/Levitronix)
Terumo DuraHeart
Thoratec IVAD
Thoratec PVAD
Toyobo
Ventracor VentrAssist
Other, Specify
Implant Date: For TAH, Percutaneous Device, Dischargeable VAD, and Non-Dischargeable VAD enter the Implant Date in MM/DD/YYYY format. This field is required.
In Place: Indicate if the device was In Place at the time of the candidate's removal from Waitlist. If the device was removed after the patient died, the device should be reported as "in place" as it was in place at the time of the patient's death.
Note: In Place is selected by default, if information was previously submitted on a heart status justification form. Deselect In Place to add an Explant Date and select an Explant Reason.
Ventricular Support: Select the option from the drop-down list. This field is required. If reporting device data for a single ventricle candidate, select “Single”.
Left
Right
Single
Explant Date: If the device was not in place at the time of the candidate's removal from Waitlist, enter the Explant Date in MM/DD/YYYY format. This field is required.
Explant Reason: Select the explant reason from the drop-down list. This field is required.
Transplanted
Multi-organ failure
Candidate Recovery
Conversion to VAD
TAH placement
Device Failure
Device Infection
Death
Has the candidate ever had any of the following devices? (TAH, IABP, VA ECMO, VV ECMO, Dischargeable VAD, Non-Dischargeable VAD, Percutaneous Device): Indicate if the candidate has had a device implanted by selecting Yes or No. This field is required.
Note: If the candidate was removed from the waiting list for a transplant, only devices implanted prior to transplant should be reported.
Device Type: Select the device type from the drop-down list. This field is required.
TAH
IABP
VA ECMO
VV ECMO
Percutaneous Device
Dischargeable VAD
Non-Dischargeable VAD
Device Brand: Select the Device Brand from the drop-down list. This field is required. If you select Other, Specify enter the device brand in the Specify field.
TAH: If you select Other, Specify enter the device brand in the Specify field.
AbioCor
SynCardia CardioWest
Other, Specify
Percutaneous Device: If you select Other, Specify enter the device brand in the Specify field.
Biomedicus
Cardiac Assist Tandem Heart
Impella Recover 2.5
Impella Recover 5.0
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
PediMag (Thoratec/Levitronix)
Cardiac Assist Protek Duo
Impella CP
Impella RP
Other Specify
Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Evaheart
Heartmate II
HeartMate III
Heartsaver VAD
Heartware HVAD
Jarvik 2000
ReliantHeartAssist 5
ReliantHeart aVAD
Worldheart Levacor
Other, Specify
Non-Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Abiomed AB5000
Abiomed BVS 5000
Berlin Heart EXCOR
Biomedicus
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
Medos
PediMag (Thoratec/Levitronix)
Terumo DuraHeart
Thoratec IVAD
Thoratec PVAD
Toyobo
Ventracor VentrAssist
Other, Specify
Implant Date: For TAH, Percutaneous Device, Dischargeable VAD, and Non-Dischargeable VAD enter the Implant Date in MM/DD/YYYY format. This field is required.
In Place: Indicate if the device was In Place at the time of the candidate's removal from Waitlist. If the device was removed after the patient died, the device should be reported as "in place" as it was in place at the time of the patient's death.
Note: In Place is selected by default, if information was previously submitted on a heart status justification form. Deselect In Place to add an Explant Date and select an Explant Reason.
Ventricular Support: Select the option from the drop-down list. This field is required. If reporting device data for a single ventricle candidate, select “Single”.
Left
Right
Single
Explant Date: If the device was not in place at the time of the candidate's removal from Waitlist, enter the Explant Date in MM/DD/YYYY format. This field is required.
Explant Reason: Select the explant reason from the drop-down list. This field is required.
Transplanted
Multi-organ failure
Candidate Recovery
Conversion to VAD
TAH placement
Device Failure
Device Infection
Death
Has the candidate had ventilatory support (i.e., ECMO, invasive mechanical ventilation) for respiratory failure since registration?: Indicate if the candidate has had ventilatory support for respiratory failure by selecting Yes or No. If Yes is selected, provide the ventilatory support data when removing lung patients for each and every instance where the patient has received some kind of ventilatory support going back to the time the patient was listed. No additional data is needed for lung patients who did not receive ventilatory support. This field is required.
Note: If the candidate was removed from the waiting list for a transplant, only devices implanted prior to transplant should be reported.
Device Type: Select the device type from the drop-down list. This field is required.
ECMO VA
ECMO VV
Invasive Mechanical Ventilation
Site: For ECMO VA and ECMO VV, select the site from the drop-down list. This field is required.
Central
Peripheral
Ambulatory Status: Select the ambulatory status from the drop-down list. This field is required.
Note: A patient is considered ambulatory if they are awake and able to continue active participation in rehab, such as exercising with a pedal device, walking, or using a hand crank. If the patient is ambulatory at any point during the mechanical ventilatory event, then they should be reported as ambulatory.
Ambulatory
Not
Ambulatory
Cannulation Date: For ECMO VA and ECMO VV, enter the Cannulation Date in MM/DD/YYYY format. This field is required.
Intubation Date: For Invasive Mechanical Ventilation, enter the Intubation Date in MM/DD/YYYY format. This field is required.
In Place: Indicate if the device was in place at the time of the candidate's removal from Waitlist. If ventilatory support was removed after the patient died, the ventilatory support should be reported as "in place" as it was in place at the time of the patient's death.
Decannulation Date: If the ECMO VA or ECMO VV device was not in place at the time of the candidate's removal from Waitlist, enter the Decannulation Date in MM/DD/YYYY format. This field is required.
Extubation Date: If the Invasive Mechanical Ventilation device was not in place at the time of the candidate's removal from Waitlist, enter the Extubation Date in MM/DD/YYYY format. This field is required.
Has the candidate had ventilatory support (i.e., ECMO, invasive mechanical ventilation) for respiratory failure since registration?: Indicate if the candidate has had ventilatory support for respiratory failure by selecting Yes or No. If Yes is selected, provide the ventilatory support data when removing lung patients for each and every instance where the patient has received some kind of ventilatory support going back to the time the patient was listed. No additional data is needed for lung patients who did not receive ventilatory support. This field is required.
Note: If the candidate was removed from the waiting list for a transplant, only devices implanted prior to transplant should be reported.
Device Type: Select the device type from the drop-down list. This field is required.
ECMO VA
ECMO VV
Invasive Mechanical Ventilation
Site: For ECMO VA and ECMO VV, select the site from the drop-down list. This field is required.
Central
Peripheral
Ambulatory Status: Select the ambulatory status from the drop-down list. This field is required.
Note: A patient is considered ambulatory if they are awake and able to continue active participation in rehab, such as exercising with a pedal device, walking, or using a hand crank. If the patient is ambulatory at any point during the mechanical ventilatory event, then they should be reported as ambulatory.
Ambulatory
Not
Ambulatory
Cannulation Date: For ECMO VA and ECMO VV, enter the Cannulation Date in MM/DD/YYYY format. This field is required.
Intubation Date: For Invasive Mechanical Ventilation, enter the Intubation Date in MM/DD/YYYY format. This field is required.
In Place: Indicate if the device was in place at the time of the candidate's removal from Waitlist. If ventilatory support was removed after the patient died, the ventilatory support should be reported as "in place" as it was in place at the time of the patient's death.
Decannulation Date: If the ECMO VA or ECMO VV device was not in place at the time of the candidate's removal from Waitlist, enter the Decannulation Date in MM/DD/YYYY format. This field is required.
Extubation Date: If the Invasive Mechanical Ventilation device was not in place at the time of the candidate's removal from Waitlist, enter the Extubation Date in MM/DD/YYYY format. This field is required.
Has the candidate ever had any of the following devices? (TAH, IABP, VA ECMO, VV ECMO, Dischargeable VAD, Non-Dischargeable VAD, Percutaneous Device): Indicate if the candidate has had a device implanted by selecting Yes or No. This field is required.
Note: If the candidate was removed from the waiting list for a transplant, only devices implanted prior to transplant should be reported.
Device Type: Select the device type from the drop-down list. This field is required.
TAH
IABP
VA ECMO
VV ECMO
Percutaneous Device
Dischargeable VAD
Non-Dischargeable VAD
Device Brand: Select the Device Brand from the drop-down list. This field is required. If you select Other, Specify enter the device brand in the Specify field.
TAH: If you select Other, Specify enter the device brand in the Specify field.
AbioCor
SynCardia CardioWest
Other, Specify
Percutaneous Device: If you select Other, Specify enter the device brand in the Specify field.
Biomedicus
Cardiac Assist Tandem Heart
Impella Recover 2.5
Impella Recover 5.0
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
PediMag (Thoratec/Levitronix)
Cardiac Assist Protek Duo
Impella CP
Impella RP
Other Specify
Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Evaheart
Heartmate II
HeartMate III
Heartsaver VAD
Heartware HVAD
Jarvik 2000
ReliantHeartAssist 5
ReliantHeart aVAD
Worldheart Levacor
Other, Specify
Non-Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Abiomed AB5000
Abiomed BVS 5000
Berlin Heart EXCOR
Biomedicus
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
Medos
PediMag (Thoratec/Levitronix)
Terumo DuraHeart
Thoratec IVAD
Thoratec PVAD
Toyobo
Ventracor VentrAssist
Other, Specify
Implant Date: For TAH, Percutaneous Device, Dischargeable VAD, and Non-Dischargeable VAD enter the Implant Date in MM/DD/YYYY format. This field is required.
In Place: Indicate if the device was In Place at the time of the candidate's removal from Waitlist. If the device was removed after the patient died, the device should be reported as "in place" as it was in place at the time of the patient's death.
Note: In Place is selected by default, if information was previously submitted on a heart status justification form. Deselect In Place to add an Explant Date and select an Explant Reason.
Ventricular Support: Select the option from the drop-down list. This field is required. If reporting device data for a single ventricle candidate, select “Single”.
Left
Right
Single
Explant Date: If the device was not in place at the time of the candidate's removal from Waitlist, enter the Explant Date in MM/DD/YYYY format. This field is required.
Explant Reason: Select the explant reason from the drop-down list. This field is required.
Transplanted
Multi-organ failure
Candidate Recovery
Conversion to VAD
TAH placement
Device Failure
Device Infection
Death
Has the candidate ever had any of the following devices? (TAH, IABP, VA ECMO, VV ECMO, Dischargeable VAD, Non-Dischargeable VAD, Percutaneous Device): Indicate if the candidate has had a device implanted by selecting Yes or No. This field is required.
Note: If the candidate was removed from the waiting list for a transplant, only devices implanted prior to transplant should be reported.
Device Type: Select the device type from the drop-down list. This field is required.
TAH
IABP
VA ECMO
VV ECMO
Percutaneous Device
Dischargeable VAD
Non-Dischargeable VAD
Device Brand: Select the Device Brand from the drop-down list. This field is required. If you select Other, Specify enter the device brand in the Specify field.
TAH: If you select Other, Specify enter the device brand in the Specify field.
AbioCor
SynCardia CardioWest
Other, Specify
Percutaneous Device: If you select Other, Specify enter the device brand in the Specify field.
Biomedicus
Cardiac Assist Tandem Heart
Impella Recover 2.5
Impella Recover 5.0
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
PediMag (Thoratec/Levitronix)
Cardiac Assist Protek Duo
Impella CP
Impella RP
Other Specify
Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Evaheart
Heartmate II
HeartMate III
Heartsaver VAD
Heartware HVAD
Jarvik 2000
ReliantHeartAssist 5
ReliantHeart aVAD
Worldheart Levacor
Other, Specify
Non-Dischargeable VAD: If you select Other, Specify enter the device brand in the Specify field.
Abiomed AB5000
Abiomed BVS 5000
Berlin Heart EXCOR
Biomedicus
CentriMag (Thoratec/Levitronix)
Maquet Jostra Rotaflow
Medos
PediMag (Thoratec/Levitronix)
Terumo DuraHeart
Thoratec IVAD
Thoratec PVAD
Toyobo
Ventracor VentrAssist
Other, Specify
Implant Date: For TAH, Percutaneous Device, Dischargeable VAD, and Non-Dischargeable VAD enter the Implant Date in MM/DD/YYYY format. This field is required.
In Place: Indicate if the device was In Place at the time of the candidate's removal from Waitlist. If the device was removed after the patient died, the device should be reported as "in place" as it was in place at the time of the patient's death.
Note: In Place is selected by default, if information was previously submitted on a heart status justification form. Deselect In Place to add an Explant Date and select an Explant Reason.
Ventricular Support: Select the option from the drop-down list. This field is required. If reporting device data for a single ventricle candidate, select “Single”.
Left
Right
Single
Explant Date: If the device was not in place at the time of the candidate's removal from Waitlist, enter the Explant Date in MM/DD/YYYY format. This field is required.
Explant Reason: Select the explant reason from the drop-down list. This field is required.
Transplanted
Multi-organ failure
Candidate Recovery
Conversion to VAD
TAH placement
Device Failure
Device Infection
Death
Public Burden Statement: The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0157 and it is valid until XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 0.27 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Information Collection Clearance Officer, 5600 Fishers Lane, Room 14N39, Rockville, Maryland, 20857 or paperwork@hrsa.gov.
OPTN
Restricted
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Title | Living Donor Registration LDR Instructions |
Author | Tara Taylor |
File Modified | 0000-00-00 |
File Created | 2025-07-03 |