Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF)

Data System for Organ Procurement and Transplantation Network

Pancreas Transplant Recipient Follow Up 6 Month - 5 Year Instructions

Pancreas Transplant Recipient Follow Up 6 Month -5 Year (TRF)

OMB: 0915-0157

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Pancreas Transplant Recipient Follow-up (TRF) Record 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.

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 death or graft failure.

TRF records generated before June 30, 2002 are forgiven except for the one-year, three-year, death/graft failure or most recently expected follow-up record. Amnesty records may be accessed by selecting the Expected/Amnesty and/or Amnesty option on the Search page. (For additional information, see Appendix T and Appendix U.)

If the patient is lost to follow-up, follow the steps for Appendix V.

The TRF record must be completed within 30 days from the record generation date. See OPTN/UNOS 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 UNetSM Help Desk at 1-800-978-4334.

Recipient Information

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 the recipient's gender is correct. 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 the transplant date is the date of the beginning of the first anastomosis. If the operation started in the evening and the first anastomosis began early the next morning, the transplant date is the date that the first anastomosis began. The transplant is considered complete when the cavity is closed and the final skin stitch/staple is applied.

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.

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.

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. (Appendix A)

Zip Code: Enter the recipient's permanent 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.

NPI #: Enter the 10-character CMS (Center for Medicare and Medicaid Services, formerly HCFA) assigned National Provider Identifier of the transplant physician. 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.

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.

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. If the recipient received another kidney from a different donor during the follow-up period, select Retransplanted. If Dead is selected, indicate the cause of death.

Living
Dead
Retransplanted

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. (Appendix X)

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. (Appendix X)

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. (Appendix X)

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. If Yes is selected, indicate the number of hospitalizations. This field is required.

Note: Hospitalizations should ONLY include inpatient visits.

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

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.

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.

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 unknown, select UNK. 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.

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.

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 less than 5 years old or has graduated from high school, select Not Applicable < 5 years old/High School graduate or GED.

Within One Grade Level of Peers
Delayed Grade Level
Special Education
Not Applicable < 5 years old/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 less than 5 years old or has graduated from high school, select Not Applicable < 5 years old/High School graduate or GED.

Full academic load
Reduced academic load
Unable to participate in academics due to disease or condition
Not Applicable < 5 years old/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. (Appendix E)

Unknown

Clinical Information

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 and weight were 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). 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: 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). 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.

BMI (Body Mass Index): For candidates less than 20 years of age during the 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: Select the status that best describes the pancreas graft status.

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

Functioning: The graft has sufficient function so that the recipient is NOT receiving any insulin or oral medication for blood sugar control.

Failed: The graft has totally failed and the patient is completely dependent upon insulin or oral medication for blood sugar control.

Patient using any method of blood sugar control? If the recipient is using any method of blood sugar control (i.e. insulin, oral medication, or diet) select Yes. If not, select No. If unknown, select UNK. This field is required.

Patient on Insulin? – If the recipient is currently on insulin then answer Yes. If the candidate is not on insulin answer No. If unknown, select UNK. This field is required if graft status is Failed.

If Yes is entered, complete the following fields:

Date insulin resumed: Enter the date that the recipient resumed insulin treatment. This field is required if graft status is Failed.

Total insulin dosage units: Enter the total insulin dosage (long term dosage + short term dosage) post transplant. The dosage units must be entered in unit/kg/day. If the candidate’s insulin dosage is unavailable, select the appropriate status from the ST field (Missing, Unknown, N/A, Not Done)..

Insulin duration of use: Enter the total number of days that the candidate received insulin prior to listing. If the candidate’s insulin duration is unavailable, select the appropriate status from the ST field (Missing, Unknown, N/A, Not Done).

Patient on oral medication to control blood sugar?: If the recipient is currently on oral medications to control blood sugar then answer Yes. If the candidate is not on oral medications to control blood sugar then answer No. If unknown, select UNK. This field is required if graft status is Failed.

Date oral medications resumed: Enter the date that the recipient began oral medications.

Patient using diet to control blood sugar: If the recipient is currently on using diet to control blood sugar levels then answer Yes. If the candidate is not answer No. If unknown, select UNK. This field is required if graft status is Failed.

If Failed is selected, complete the following fields:

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

Pancreas Graft Removed: If the pancreas graft has totally failed, the recipient is completely dependent on insulin for blood glucose control, and the pancreas graft was removed, select Yes. If not, select No. If unknown, select Unknown. This field is optional.

Date Pancreas Graft Removed: If Yes is selected, enter the date the pancreas graft was removed using the standard 8-digit numeric format MM/DD/YYYY. This field is optional.

Primary Cause of Graft Failure: Select the cause of graft failure. If Other, Specify is selected, enter the cause of failure in the space provided.

Graft/Vascular Thrombosis
Infection
Bleeding
Anastomotic Leak
Primary Non-Function (Graft Never Functioned Post-Transplant)
Acute Rejection
Chronic Rejection
Hyperacute Rejection
Biopsy Proven Isletitis
Pancreatitis
Other, Specify

Note: The date of failure and the date insulin was resumed should be the same, unless the patient has a previous partial graft function reported.

Contributory causes of graft failure: For each of the causes listed select Yes, No, or UNK to indicate whether each is a contributory cause of graft failure. Select No for the primary cause, since it cannot be both primary and secondary cause of graft failure. If Other, Specify is selected, specify the cause in the space provided.

Graft/Vascular Thrombosis
Infection
Bleeding
Anastomotic Leak
Acute Rejection
Chronic Rejection
Biopsy Proven Isletitis
Pancreatitis
Patient Noncompliance
Other, Specify

Conv. From Bladder to Enteric Drain Performed: If the pancreas graft duct has been changed from bladder to enteric during this follow-up period, select Yes. If not, select No. If unknown, select UNK. If Yes is selected, indicate when the conversion occurred. On the recipient's TRR, if Enteric w/Roux-En-Y or Enteric w/o Roux-En-Y was selected for Duct Management, this question does not apply for this recipient and you must select N/A. This field is required.

If Yes, Enteric Drainage Date: If Yes is selected, enter the date of the conversion during this follow-up period using the standard 8-digit numeric format of MM/DD/YYYY.

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). This field is required.

C-peptide Value: Enter the c-peptide value in ng/mL, range 0 - 15.00. If the value is unavailable, select the appropriate status from the ST field (Missing, Unknown, N/A, Not Done). For undetectable c-peptide values where the c-peptide value is reported as <X value, the threshold (i.e. X) is the acceptable value. For example, if c-peptide value is reported as <0.1 then the threshold is 0.1 and should be entered as “0.1” into the c-peptide value field.  This field is required

Hba1c (%) – Enter the Hba1c percentage (0.0 – 99.9). If the value is unavailable, select the appropriate status from the ST field (Missing, Unknown, N/A, Not Done). This field is required

Pancreas Transplant Complications (Not leading to graft failure): For each of the complications listed indicate if the complication occurred during this follow-up period. Do not select Yes if the complication contributed to failure of the pancreas graft.

Pancreatitis: If the recipient was diagnosed during this follow-up period as having pancreatitis, select Yes. If not, select No. If unknown, select UNK.

Anastomotic Leak: If the recipient exhibited signs and symptoms of an anastomotic leak during this follow-up period, select Yes. If not, select No. If unknown, select UNK.

Abscess or Local Infection: If the recipient exhibited signs and symptoms of abscess or local infection during this follow-up period, select Yes. If not, select No. If unknown, select UNK.

Other Complications: If a complication other than those listed occurred during this follow-up period, enter the complication in the space provided.

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. If Yes is selected, indicate if a biopsy was done to confirm acute rejection. This field is required.

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.

Positive
Negative
UKN/Cannot Disclose
Not Done

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

Positive
Negative
UKN/Cannot Disclose
Not Done

HbsAg: Select the results from the drop-down list.

Positive
Negative
UKN/Cannot Disclose
Note Done

HBV DNA: Select the results from the drop-down list.

Positive
Negative
UKN/Cannot Disclose
Not Done

HBV Core Antibody: Select the results from the drop-down list.

Positive
Negative
UKN/Cannot Disclose
Not Done

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

Positive
Negative
UKN/Cannot Disclose
Not Done

HCV NAT: Select the results from the drop-down list.

Positive
Negative
UKN/Cannot Disclose
Not Done

Post Transplant Malignancy: If the recipient has been diagnosed with any malignant cancer since the last follow-up, select Yes. If not, select No. If unknown, select UNK. If Yes is selected, at least one of the fields listed below must be completed. A Post Transplant Malignancy record will generate when one or more of the fields listed below is selected. For additional information, see

Donor Related: If the malignancy is donor related, select Yes . If not, select No. If unknown, select UNK. If Yes is selected, the Donor Related section will be displayed on the Post Transplant Malignancy record. For additional information, see

Recurrence of Pre-Tx tumor: If a pre-transplant tumor has recurred, select Yes. If not, select No. If unknown, select UNK. If Yes is selected, the Recurrence of Pre-transplant Malignancy section will be displayed on the Post Transplant Malignancy record. For additional information, see

De Novo Solid Tumor: If the cancer was a De Novo solid tumor, select Yes If not, select No. If unknown, select UNK. If Yes is selected, the Post Transplant De Novo Solid Tumor section will be displayed on the Post Transplant Malignancy record. For additional information, see

De Novo Lymphoproliferative disease and Lymphoma: If the cancer was post transplant lymphoproliferative disease or lymphoma, select Yes . If not, select No. If unknown, select UNK. If Yes is selected, the Post Tx Lymphoproliferative Disease and Lymphoma section will be displayed on the Post Transplant Malignancy record. For additional information, see

Note: Please report each type of malignancy only once in the follow-up process.

Note: When a patient has a tumor during one follow up period and the tumor continues into the next follow-up period without going away, the tumor should only be reported on that first follow-up record and not reported on the next follow-up record. The tumor should be reported on subsequent follow-up records ONLY if the tumor goes away and then returns in the next follow-up period.

Immunosuppressive Information

Previous Validated Maintenance Follow-up Medications: The follow-up Immunosuppression medication(s) indicated in the patient's most recently validated Transplant Recipient Registration (TRR) or Transplant Recipient Follow-up (TRF) record will be listed.

Note: If a drug cannot be indicated as Maintenance in the Transplant Recipient Registration (TRR), then it cannot be indicated as Current Maintenance or Previous Maintenance in the TRF. If the drug cannot be indicated as Anti-rejection in the TRR, then it cannot be indicated as Anti-rejection in the TRF.

Were any medications given during the follow-up period for maintenance: (List of Changes to Maintenance Medications codes)

If there were immunosuppressive medications during this follow-up period, select Yes, same as validated TRR form. The drugs on the previously validated TRR will pre-populate.

If there have been changes in medications during this follow-up period, select Yes, but different than validated TRR form. Then select the appropriate Immunosuppressive Medications by placing a checkmark in the Current Maint or AR column.

If no medications were given during this follow-up period, select None given.

Note: If any medications were given during the 6-month follow-up period for maintenance, immunosuppression medications from the patient's validated TRR will be listed.

Immunosuppressive Medications

For each of the immunosuppressant medications listed, check Previous Maintenance (Prev Maint), Current Maintenance (Curr Maint) or Anti-rejection (AR) to indicate all medications that were prescribed for the recipient during this follow-up period, and for what reason. If a medication was not given, leave the associated box(es) blank.

Previous Maintenance (Prev Maint) includes all immunosuppressive medications given during the report period, which covers the period from the last clinic visit to the current clinic visit, for varying periods of time which may be either long-term or intermediate term with a tapering of the dosage until the drug is either eliminated or replaced by another long-term maintenance drug (e.g., Prednisone, Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Azathioprine, or Rapamycin). This does not include any immunosuppressive medications given to treat rejection episodes.

Current Maintenance (Curr Maint) includes all immunosuppressive medications given at the time of the current clinic visit to begin in the next report period for varying periods of time which may be either long-term or intermediate term with a tapering of the dosage until the drug is either eliminated or replaced by another long-term maintenance drug (e.g., Prednisone, Cyclosporine, Tacrolimus, Mycophenolate Mofetil, Azathioprine, or Rapamycin). This does not include any immunosuppressive medications given to treat rejection episodes.

Note: If the recipient was taking maintenance medications during the follow-up period but is now deceased, then select Yes, but different than previous validated report, and check-off all applicable medications in the Previous column only. Do not check-off any medications in the Current column.

Note: On Recipient Death (RD) records, any maintenance medications given during the follow-up period should be noted as Previous, and nothing should be noted in the Current column.

Anti-rejection (AR) immunosuppression includes all immunosuppressive medications given for the purpose of treating an acute rejection episode since the last clinic visit (e.g., Methylprednisolone, Atgam, OKT3, or Thymoglobulin). When switching maintenance drugs (e.g., from Tacrolimus to Cyclosporine; or from Mycophenolate Mofetil to Azathioprine) because of rejection, the drugs should not be listed under AR immunosuppression, but should be listed under maintenance immunosuppression.

Note: The Anti-rejection field refers to any anti-rejection medications since the last clinic visit, not just at the time of the current clinic visit.

Note: As further clarification, drugs that are used with the intention to maintain recipients long-term are medications such as Tacrolimus, Cyclosporine, Azathioprine, Mycophenolate Mofetil and Prednisone. These maintenance medications should not be listed as AR medications to treat acute rejection. When patients have a true acute rejection, they are given anti-rejection medication such as steroids, OKT3, ATG, Simulect and Zenapax, in addition to the maintenance medications. These are the medications that should be selected as anti-rejection.

If an immunosuppressive medication other than those listed is being administered (e.g., new monoclonal antibodies), select Previous Maint, or Current Maint, or AR next to Other Immunosuppressive Medication field, and enter the full name of the medication in the space provided. Do not list non-immunosuppressive medications.

Drug used for induction, acute rejection, or maintenance

Steroids (prednisone, methylprednisolone, Solumedrol, Medrol, Decadron)

Drugs used for induction or acute rejection

Atgam

Campath (alemtuzumab, anti-CD52)

Cytoxan (cyclophosphamide)

Methotrexate (Folex PFS, Mexate-AQ, Rheumatrex)

OKT3 (Orthoclone, muromonab)

Rituxan (rituximab)

Simulect (basiliximab)

Thymoglobulin

Drugs primarily used for maintenance

Cyclosporine, select from the following:

  • EON (generic cyclosporine)

  • Gengraf (Abbott cyclosporine)

  • Neoral (CyA-NOF)

  • Other generic cyclosporine, specify brand:

  • Sandimmune (cyclosporine A)

  • Imuran (azathioprine, AZA)

  • Leflunomide (LFL)

Mycophenolate acid, select from the following:

  • CellCept (MMF)

  • Generic MMF (generic CellCept)

  • Myfortic (mycophenolate acid)

  • Nulojix (belatacept)

  • Rapamune (sirolimus, Rapamycin)

Tacrolimus, select from the following:

  • Astagraf XL (extended release tacrolimus)

  • Generic tacrolimus (generic Prograf)

  • Prograf (FK506)

  • Zortress (everolimus)

Other drugs

Other immunosuppressive medication, specify:



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