HeartLung Transplant Recipient Follow Up 1 to 5 Year_Instructions

Data System for Organ Procurement and Transplantation Network

HeartLung Transplant Recipient Follow Up 1 to 5 Year_Instructions

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Thoracic Transplant Recipient Follow-up (TRF) Field Descriptions

Transplant Recipient Follow-up (TRF) records are generated in Tiedi^® at six months, one year and annually thereafter following transplantation, until either graft failure, recipient death or lost to follow-up is reported. Forms are generated by the age at transplant, not the age at listing. Pediatric follow-up records will continue to generate through the recipient's 25th birthday. The system will automatically update the next follow-up record to Adult as of the recipient's 26th birthday.

The TRF record is to be completed by the transplant center responsible for follow-up of the recipient at intervals of six months, one year and annually thereafter. The record is to contain only the applicable patient information since the last follow-up period. It is not to contain information pertaining solely to the previous or next follow-up period. For example: the 6-month follow-up should contain information from the time after the TRR was completed to the 6-month transplant anniversary date; the 1-year follow-up should contain information from the day after the 6-month transplant anniversary date to the 1-year transplant anniversary date; the 2-year follow-up should contain information from the day after the 1-year transplant anniversary date to the 2-year anniversary date.

If the recipient dies or experiences a graft failure between follow-up intervals, complete an interim record containing the information pertinent to the patient no later than the date of death or graft failure. For example: an interim graft failure is reported with a graft failure date of March 10. The patient status date should also be March 10 and the information collected on the form should be based on patient evaluation no later than March 10.

If the patient is lost to follow-up, follow the steps for Reporting Lost to Follow-up.

The TRF record must be completed within 90 days from the record generation date. See OPTN Policies for additional information. Use the search feature to locate specific policy information on Data Submission Requirements.

To correct information that is already displayed on an electronic record, call the UNet^SM Help Desk at 1-800-978-4334.

Recipient Information

Organ Type: This field is read-only.

Follow-up Code: This field is read-only.

Name: Verify the last name, first name and middle initial of the transplant recipient is correct. If the information is incorrect, corrections may be made on the recipient's TCR record.

DOB: Verify the displayed date is the recipient's date of birth. If the information is incorrect, corrections may be made on the recipient's TCR record.

SSN: Verify the recipient's social security number is correct. If the information is incorrect, contact the Help Desk at 1-800-978-4334.

Gender: Verify recipient’s sex (Male or Female), based on biologic and physiologic traits at birth. If sex at birth is unknown, report sex at time of registration as reported by recipient or documented in medical record. The intent of this data collection field is to capture physiologic characteristics that may have an impact on recipient size matching or graft outcome. If the information is incorrect, corrections may be made on the recipient's TCR record.

HIC: Verify the 9 to 11 character Health Insurance Claim number for the recipient indicated on the recipient's most recently updated TCR record is correct. If the recipient does not have a HIC number, you may leave this field blank.

Tx Date: The recipient's transplant date, reported in the Recipient Feedback, will display. Verify that the displayed transplant date is correct. 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.

Previous Follow-up: The recipient's follow-up status, reported in the previous TRF record, will display. Verify the recipient's previous follow-up status is correct.

Previous Px Stat Date: The recipient's patient status date, reported in the previous TRF record, will display. Verify the recipient's previous patient status date is correct.

Transplant Discharge Date: Enter the date the recipient was released to go home, or verify that the discharge date displayed is the date the recipient was released to go home. The patient's hospital stay includes total time spent in different units of the hospital, including medical and rehab. This field is required.

Note: The Transplant Discharge Date can only be edited on the patient's TRR, 6-month TRF and 1-year TRF. To correct this information on a follow-up that is after the 1-year TRF, access one of these three records and enter the correct date. The corrected information will automatically update on the other records.

State of Permanent Residence: Select the name of the state of the recipient's permanent address at the time of follow-up (location of full-time residence, not follow-up center location). This field is required. (List of State codes)

Zip Code: Enter the recipient's zip code at the time of follow-up (location of full-time residence, not follow-up center location). This field is required.

Provider Information

Recipient Center: The Recipient Center information reported in Waitlist displays. Verify that the center information is the hospital where the transplant operation was performed. The Provider Number is the 6-character Medicare identification number of the hospital. This is followed by the Center Code and Center Name.

Followup Center: The follow-up center, reported in the recipient's previous validated TRF record, will display. Verify the center name, center code and provider number for the center following the patient.

Physician Name: Enter the name of the physician who is following the patient. If the patient is being seen by a nurse practitioner or physician's assistant, enter the name of the practitioner providing care (e.g. physician, nurse practitioner, physician’s assistant).

NPI #: Enter the 10-character CMS (Center for Medicare and Medicaid Services, formerly HCFA) assigned National Provider Identifier of the transplant physician or practitioner providing care (e.g. physician, nurse practitioner, physician’s assistant). Your hospital billing office may be able to obtain this number for you.

Follow-up Care Provided By: Indicate where the follow-up care was provided. If Other Specify is selected, specify the provider in the space provided. (List of Provider Type codes)

Transplant Center
Non Transplant Center Specialty Physician
Primary Care Physician
Other Specify

Donor Information

UNOS Donor ID #: The UNOS Donor ID number, reported in the Recipient Feedback, will display. Each potential donor is assigned an identification number by OPTN/UNOS. This ID number corresponds to the date the donor information was entered into the OPTN/UNOS computer system.

Donor Type: The donor type, reported in the Recipient Feedback, will display. Verify the recipient's donor type is correct. If the information is incorrect, contact the Help Desk at 1-800-978-4334.

Deceased indicates the donor was not living at the time of donation.
Living indicates the donor was living at the time of donation.

OPO: This field is read-only.

Patient Status

Date: Last Seen, Retransplanted or Death: Enter the date the patient was last seen, or the date of death, or retransplant for this recipient, using the standard 8-digit numeric format of MM/DD/YYYY. The follow-up records (6-month, 1-year, 2-year, etc.) are to be completed within 30 days of the 6-month and yearly anniversaries of the transplant date. If the recipient died or the graft failed, and you have not completed an interim follow-up indicating these events, the 6-month and annual follow-ups should be completed indicating one of those two events.

Patient Status: If the recipient is living at the time of follow-up, select Living. If the recipient died during this follow-up period, select Dead. Follow-up forms will no longer be generated for this patient. If Dead is selected, indicate the cause of death. If the recipient received another thoracic organ from a different donor during the follow-up period, select Retransplanted. If the recipient was not seen during this follow-up period, select Not Seen; however, an annual follow-up form will be generated for this patient next year. This field is required.

Living
Dead
Retransplanted
Not Seen

Primary Cause of Death: If the Patient Status is Dead, select the patient's cause of death. If an Other code is selected, enter the other cause of death in the space provided. (List of Primary Cause of Death codes)

Contributory Cause of Death: If the Patient Status is Dead, select the patient's contributory cause of death. If an Other code is selected, enter the other cause of death in the space provided. (List of Contributory Cause of Death codes)

Has the patient been hospitalized since the last patient status date: If the recipient has been hospitalized since the last patient status report, regardless of patient status (living, dead, or retransplanted), select Yes. If not, select No. If unknown, select UNK. This field is required.

Note: Hospitalizations should ONLY include inpatient visits.

Hospitalized for Rejection: If the recipient was hospitalized for rejection during this follow-up period, select Yes. If not, select No. If unknown, select UNK.

Hospitalized for Infection: If the recipient was hospitalized for infection during this follow-up period, select Yes. If not, select No. If unknown, select UNK.

Functional Status: Select the choice that best describes the recipient's functional status at the time of follow-up. This field is required. (List of Functional Status codes)

Note: The Karnofsky Index will display for adults aged 18 and older.

100% - Normal, no complaints, no evidence of disease
90% - Able to carry on normal activity: minor symptoms of disease
80% - Normal activity with effort: some symptoms of disease
70% - Cares for self: unable to carry on normal activity or active work
60% - Requires occasional assistance but is able to care for needs
50% - Requires considerable assistance and frequent medical care
40% - Disabled: requires special care and assistance
30% - Severely disabled: hospitalization is indicated, death not imminent
20% - Very sick, hospitalization necessary: active treatment necessary
10% - Moribund, fatal processes progressing rapidly
Unknown

Note: The Lansky Score will display for pediatrics aged less than 18.

100% - Fully active, normal
90% - Minor restrictions in physically strenuous activity
80% - Active, but tires more quickly
70% - Both greater restriction of and less time spent in play activity
60% - Up and around, but minimal active play; keeps busy with quieter activities
50% - Can dress but lies around much of day; no active play; can take part in quiet play/activities
40% - Mostly in bed; participates in quiet activities
30% - In bed; needs assistance even for quiet play
20% - Often sleeping; play entirely limited to very passive activities
10% - No play; does not get out of bed
Not Applicable (patient < 1 year old)
Unknown

Note: This evaluation should be in comparison to the person's normal function, indicating how the patient's disease has affected their normal function.

Cognitive Development: (Complete for recipients younger than 18 years of age at transplant and younger than 26 years of age at follow-up.) Select the choice that best describes the recipient's cognitive development at the time of follow-up. (List of Cognitive Development codes)

Definite Cognitive Delay/Impairment (verified by IQ score <70 or unambiguous behavioral observation)

Probable Cognitive Delay/Impairment (not verified or unambiguous but more likely than not, based on behavioral observation or other evidence)

Questionable Cognitive Delay/Impairment (not judged to be more likely than not, but with some indication of cognitive delay/impairment such as expressive/receptive language and/or learning difficulties)

No Cognitive Delay/Impairment (no obvious indicators of cognitive delay/impairment)

Not Assessed

Motor Development: (Complete for recipients younger than 18 years of age at transplant and younger than 26 years of age at follow-up.) Select the choice that best describes the recipient's motor development at the time of follow-up. (List of Motor Development codes)

Definite Motor Delay/Impairment (verified by physical exam or unambiguous behavioral observation)

Probable Motor Delay/Impairment (not verified or unambiguous but more likely than not, based on behavioral observation or other evidence)

Questionable Motor Delay/Impairment (not judged to be more likely than not, but with some indication of motor delay/impairment)

No Motor Delay/Impairment (no obvious indicators of motor delay/impairment)

Not Assessed

Working for income: (Complete for recipients 18 years of age or older.) If the recipient was working for income at the time of follow-up, select Yes. If not, select No. If reporting the recipient's death, indicate if the recipient was working for income just prior to death.

If No, Not Working Due To: If No is selected, indicate the reason why the recipient was not working. (This field is optional for adult recipients only.) (List of Not Work Reason codes)

Disability - A physical or mental impairment that interferes with or prevents a candidate from working (e.g. arthritis, mental retardation, cerebral palsy, etc).

Demands of Treatment - An urgent medical treatment that prevents a candidate from working (e.g. Dialysis).

Insurance Conflict - Any differences between a candidate and insurance company that prevents them from working.

Inability to Find Work - The lack of one's ability to find work (e.g. lack of transportation, work experience, over qualification, unavailable work, etc.).

Patient Choice - Homemaker - A candidate who chooses to manage their own household, instead of performing work for pay.

Patient Choice - Student Full Time/Part Time - A candidate who is enrolled and/or participating in college.

Patient Choice - Retired - A candidate who no longer has an active working life such as an occupation, business or office job.

Patient Choice - Other - Any reason not listed above that would prevent a candidate from working.

Not Applicable - Hospitalized - Select only if the patient's Medical Condition indicates they are in the hospital.

Unknown

If Yes: If Yes is selected, indicate the recipient's working status. This field is optional for adult recipients only. (List of Working codes)

Working Full Time
Working Part Time due to Demands of Treatment
Working Part Time due to Disability
Working Part Time due to Insurance Conflict
Working Part Time due to Inability to Find Full Time Work
Working Part Time due to Patient Choice
Working Part Time Reason Unknown
Working, Part Time vs. Full Time Unknown

Academic Progress: (This field is required for recipients less than 18 years of age.) Select the choice that best describes the recipient's academic progress at the time of follow-up. If reporting the recipient's death, select the choice that best describes the recipient's progress just prior to death. If the recipient is too young for school or has graduated from high school, select Not Applicable, too young for school/High School graduate or GED. (List of Academic Progress codes)

Within One Grade Level of Peers
Delayed Grade Level
Special Education
Not Applicable, too young for school/High School graduate or GED
Status Unknown

Academic Activity Level: (This field is required for recipients less than 18 years of age.) Select the choice that best describes the recipient's academic activity level at the time of follow-up. If reporting the recipient's death, select the choice that best describes the recipient's academic activity just prior to death. If the recipient is too young for school or has graduated from high school, select Not Applicable, too young for school/High School graduate or GED. (List of Academic Activity Level codes)

Full academic load
Reduced academic load
Unable to participate in academics due to disease or condition
Not Applicable, too young for school/High School graduate or GED
Status Unknown

Primary Insurance at Follow-up: Select the recipient's source of primary payment (largest contributor) during the follow-up period.

Private insurance refers to funds from agencies such as Blue Cross/Blue Shield, etc. It also refers to any worker's compensation that is covered by a private insurer.

Public insurance - Medicaid refers to state Medicaid funds.

Public insurance - Medicare FFS (Fee-for-Service) refers to funds, from the government in which doctors and other health care providers are paid for each service provided to a recipient. For additional information about Medicare, see http://www.medicare.gov/.

Public insurance - Medicare & Choice refers to funds from the government in which doctors and other health care providers are paid for each service provided to a recipient, along with additional benefits such as coordination of care or reducing-out-of-pocket expenses. Sometimes a recipient may receive additional benefits such as prescription drugs. For additional information about Medicare, see http://www.medicare.gov/.

Public insurance - CHIP (Children's Health Insurance Program)

Public insurance - Department of VA refers to funds from the Veterans Administration.

Public insurance - Other government

Self indicates that the cost of follow-up will be paid for by the recipient.

Donation indicates that a company, institution, or individual(s) donated funds to pay for the follow-up period and care of the recipient.

Free Care indicates that the transplant hospital will not charge recipient for the costs of the follow-up period.

Foreign Government Specify refers to funds provided by foreign government (Primary only). Specify foreign country in the space provided. (List of Foreign Country codes)

Unknown

Clinical Information

Height Date of Measurement: (Complete for recipients younger than 18 years of age at transplant and younger than 26 years of age at follow-up.) Enter the date, using the 8-digit format of MM/DD/YYYY, the recipient’s height was measured. This field is required.

Height: Enter the height of the recipient at the time of follow-up in the appropriate space, in feet and inches or centimeters. If the recipient’s height is unavailable, select the appropriate status from the ST field (N/A, Not Done, Missing, Unknown). (List of Status codes) For recipients 18 years old or younger at the time of follow-up, UNet will generate and display calculated percentiles based on the 2000 CDC growth charts. This field is required for pediatric recipients only.)

Weight Date of Measurement: (Complete for recipients younger than 18 years of age at transplant and younger than 26 years of age at follow-up.) Enter the date, using the 8-digit format of MM/DD/YYYY, the recipient’s weight was measured. This field is required.

Weight: Enter the weight of the recipient at the time of follow-up in the appropriate space, in pounds or kilograms. If the recipient’s weight is unavailable, select the appropriate status from the ST field (N/A, Not Done, Missing, Unknown). (List of Status codes) For recipients 18 years old or younger at the time of follow-up, UNet will generate and display calculated percentiles based on the 2000 CDC growth charts. This field is required for pediatric recipients only.

BMI (Body Mass Index): For candidates less than 20 years of age during this follow-up period, UNet will generate and display calculated percentiles based on the 2000 CDC growth charts.

Percentiles are the most commonly used clinical indicator to assess the size and growth patterns of individual children in the United States. Percentiles rank the position of an individual by indicating what percent of the reference population the individual would equal or exceed (i.e. on the weight-for-age growth charts, a 5 year-old girl whose weight is at the 25th percentile, weighs the same or more than 25 percent of the reference population of 5-year-old girls, and weighs less than 75 percent of the 5-year-old girls in the reference population). For additional information about CDC growth charts, see http://www.cdc.gov/.

Note: Users who check the BMI percentiles against the CDC calculator may notice a discrepancy that is caused by the CDC calculator using 1 decimal place for height and weight and UNet using 4 decimal places for weight and 2 for height.

Graft Status:

If the graft is functioning at the time of follow-up, select Functioning. If the graft is not functioning, select Failed.

If Failed is selected, complete the following fields.

Date of Graft Failure: Enter the date of graft failure using the standard 8-digit numeric format of MM/DD/YYYY.

Note: If death is indicated for the recipient, and the death was a result of some other factor unrelated to graft failure, select Functioning.

Primary Cause of Graft Failure: Select the cause of graft failure.

Primary Non-Function
Acute Rejection
Chronic Rejection/Atherosclerosis
Other, Specify

Titer Information: Complete this section for pediatric lung and heart-lung recipients only.

Note: For those individuals who received a heart and/or lung from a donor with an incompatible blood type, the most recent Anti-A and/or Anti-B titer values must be reported upon graft failure or death.

Titer values entered on the TRR: Titer values entered on the Transplant Recipient Registration display. This field is read-only.

Anti-A Titer at time of transplant: The Anti-A titer value taken at time of transplant displays. This field is read-only.

Most Recent Anti-A Titer: Select the Most Recent Anti-A Titer value, Not taken or Not available if applicable. Enter the Sample Date in mm/dd/yyyy format. The date to be reported is the date when the candidate's blood was drawn.

Titer values entered on the TRR: Titer values entered on the Transplant Recipient Registration display. This field is read-only.

Anti-B Titer at time of transplant: The Anti-B titer value taken at time of transplant displays. This field is read-only.

Most Recent Anti-B Titer: Select the Most Recent Anti-B Titer value, Not taken or Not available if applicable. Enter the Sample Date in mm/dd/yyyy format. The date to be reported is the date when the candidate's blood was drawn.

Graft Function: For heart only recipients, complete the Heart section. For lung only recipients, complete the Lung section. For heart-lung recipients, complete both sections.

HEART (AND HEART/LUNG):

Ejection Fraction: Enter the most recent ejection fraction available for the recipient. If unavailable, select the status for the ST field (N/A, Not Done, Missing, Unknown). (List of Status codes) The ejection fraction range must fall between 5% and 90%. If you only enter a shortening fraction, select Not Done.

Shortening Fraction: (Displays for recipient's 18 years of age or younger.) Enter the most recent shortening fraction available for a pediatric patient 18 years old or younger. The shortening fraction range must fall between 0% and 50%. If unavailable, select the status for the ST field (N/A, Not Done, Missing, Unknown). (List of Status codes)

Note: If you only enter a Shortening Fraction, select Not Done in the Ejection Fraction field.

Pacemaker: If the recipient has had a permanent pacemaker inserted since the last follow-up, select Yes. If not, select No. If unknown, select Unk.

Coronary Artery Disease: If the recipient has experienced new signs and symptoms of coronary artery disease sine the follow-up, select Yes. If not, select No. If unknown, select Unk.

Note: If this is a 1-year follow-up, then report any new signs or symptoms since transplant.

LUNG (AND HEART/LUNG):

Date Test Performed -

FEV1 -

FVC

FEF 25-75

Date Test Performed

FEV1 -

FVC

FEF 25-75

Date Test Performed

FEV1 -

FVC

FEF 25-75

Current Supplemental O2 requirements at rest and/or at exercise

At rest: FiO2 or Flow -

With exercise: FiO2 or Flow –

Post Transplant Events:

Indicate if each post transplant event was newly experienced by the patient during this follow-up period.

New diabetes onset between last follow-up to the current follow-up: The intent of this field is to capture NEW post-transplant diabetes onset since last follow-up period. Select Yes:

If the recipient developed post-transplant diabetes since the last follow-up
If previous post-transplant diabetes was reported, later resolved, and has been re-diagnosed during the most recent follow-up period

Select No:

If no new diabetes diagnosis since previous follow-up
If onset of post-transplant diabetes has been documented on a previous follow-up and has not resolved

Select UNK, if unknown.

Note: A patient should not be considered as having developed diabetes based on gestational diabetes only.

If Yes, Insulin Dependent: If the recipient has started insulin since the last follow-up, select Yes. If not, select No. If unknown, select UNK. Note: The field can only be edited on the patient's 1-year TRF. To correct this information on a 1-year TRF, access this record and enter the correct date. The corrected information will automatically update on the subsequent records.

Most Recent Serum Creatinine: Enter the most recent serum creatinine, in mg/dl, available. If unavailable, select the status from the ST field (N/A, Not Done, Missing, Unknown).

Chronic Dialysis: If the recipient has had chronic peritoneal or hemodialysis during this follow-up period, select Yes. If not, select No. If unknown, select UNK.

Note: Chronic dialysis means that the patient has developed end stage renal disease and is expected to remain on dialysis. If the patient has filled out a CMS 2728 form which registers the patient as having ESRD and enters them into the United States Renal Data System (USRDS), then they have chronic dialysis.

Renal Tx since Thoracic Tx: If the recipient has received a renal transplant during this follow-up period, select Yes. If not, select No. If unknown, select UNK.

Did patient have any acute rejection episodes during the follow-up period: If the recipient experienced at least one episode during this follow-up period, select Yes. If not, select No. If unknown, select Unknown. (List of Any Acute Rejection Episodes codes)

Note: If this is a 1-year follow-up, then report any new signs or symptoms since transplant.

Yes, at least one episode treated with anti-rejection agent
Yes, none was treated with additional anti-rejection agent
No
Unknown

Viral Detection: The following fields will be required on 6-month and 1-year TRFs if the recipient received an organ from a donor that was classified as “CDC High Risk” on the DDR.

HIV Serology: Select the results from the drop-down list.