Pancreas Registration Instructions

TRR Pancreas Help.pdf

Organ Procurement and Transplantation Network and Scientific Registry of Transplant Recipients Data System

Pancreas Registration Instructions

OMB: 0915-0157

Document [pdf]
Download: pdf | pdf
Pancreas Transplant Recipient Registration (TRR)
Record Field Descriptions
The Transplant Recipient Registration (TRR) records are generated and available immediately
after a transplant event is reported through the recipient feedback process in Waitlist. A TRR
will also be generated in the case of a living donor transplant, where a recipient was added
through the donor feedback process in Tiedi®. The Transplant Recipient Registration (TRR)
record is completed by the transplant center performing the transplant. The registration and
hospital discharge follow-up information is combined in this record.
Complete the TRR at hospital discharge or six weeks post transplant, whichever is first.
If the recipient is still hospitalized at six weeks post transplant, provide the most recent
information available regarding the recipient's progress.
View OPTN/UNOS Policy on Data Submission Requirements for additional information.
To correct information that is already displayed on an electronic record, call 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: Verify the displayed 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. The
transplant date is indicated immediately after a transplant event is reported through the
recipient feedback process in Waitlist and in the case of a living donor transplant, where a
recipient was added through the donor feedback process in Tiedi.
State of Permanent Residence: Select the name of the state, of the recipient's permanent
address, at the time of transplant.
Permanent Zip: Enter the recipient's zip code, of their permanent address, at the time of
transplant.
Provider Information
Recipient Center: The recipient center will display. Verify the transplant center name and the
center code, and the provider number, (6-character Medicare identification number of the
hospital where the transplant recipient was transplanted) are correct.
Surgeon Name: Enter the name of the primary surgeon, who performed the transplant
operation, and under whose name the transplant is billed.

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.
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 1-800978-4334.
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
Primary Diagnosis: Select the primary diagnosis for the disease requiring a transplant for
this recipient at the time of transplant. If the recipient has had a previous transplant for the
same organ type, enter Retransplant/Graft Failure as the primary diagnosis for that organ. If
Other, Specify is selected, enter the primary diagnosis in the space provided.
Date of: Report or Death: Enter the date the hospital reported the recipient as living,
retransplanted (when the data was obtained prior to the recipient's discharge) or the date of the
recipient's death, using the standard 8-digit numeric format of MM/DD/YYYY.
Patient Status: Select the appropriate status for this recipient. 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.
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.
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.
Note: If the patient is being retransplanted, access the patient's last record for their
previous transplant and select Retransplanted in the Patient Status field. This will
stop the generation of TRF records associated with the previous transplant.
Transplant Hospitalization:
Date of Admission to Tx Center: Enter the date the recipient was admitted to the
transplant center, using the standard 8-digit MM/DD/YYYY format.
Date of Discharge from Tx Center: Enter the date the recipient was released to go home,
using the standard 8-digit MM/DD/YYYY format. The recipient's hospital stay includes total
time spent in different units of the hospital, including medical and rehab. This information is
not required in the TRR record, but if entered here, it will automatically fill in the future TRF
records. It is required in the TRF record.

Note: Leave this field blank if the recipient was removed from the waiting list with a
code of 21, indicating the recipient died during the transplant procedure.
Was patient hospitalized during the last 90 days prior to the transplant admission? If
the recipient was hospitalized during the last 90 days prior to transplant admission, select
Yes. If not, select No. If unknown, select UNK. This field is optional.
Medical Condition at time of transplant: Select the choice that best describes the recipient's
condition and location just prior to the time of transplant.
In Intensive Care Unit
Hospitalized Not in ICU
Not Hospitalized
Functional Status: Select the choice that best describes the recipient's functional status just
prior to the time of transplant.
Note: The Karnofsky Index will display for adults aged 18 and older.
10% - Moribund, fatal processes progressing rapidly
20% - Very sick, hospitalization necessary: active treatment necessary
30% - Severely disabled: hospitalization is indicated, death not imminent
40% - Disabled: requires special care and assistance
50% - Requires considerable assistance and frequent medical care
60% - Requires occasional assistance but is able to care for needs
70% - Cares for self: unable to carry on normal activity or active work
80% - Normal activity with effort: some symptoms of disease
90% - Able to carry on normal activity: minor symptoms of disease
100% - Normal, no complaints, no evidence of disease
Unknown
Note: The Lansky Scale will display for pediatrics aged 1 to 17.
10% - No play; does not get out of bed
20% - Often sleeping; play entirely limited to very passive activities
30% - In bed; needs assistance even for quiet play
40% - Mostly in bed; participates in quiet activities
50% - Can dress but lies around much of day; no active play; can take part in quiet
play/activities
60% - Up and around, but minimal active play; keeps busy with quieter activities
70% - Both greater restriction of and less time spent in play activity
80% - Active, but tires more quickly
90% - Minor restrictions in physically strenuous activity
100% - Fully active, normal
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.
Physical Capacity: (Complete for recipients older than 18 years of age.) Select the choice that
best describes the recipient's physical capacity at the time of listing. If the recipient's Medical
Condition indicates they are hospitalized, select Not Applicable (hospitalized). This field is
optional for adult recipients only.
No Limitations
Limited Mobility
Wheelchair bound or more limited
Not Applicable (hospitalized)
Unknown

Physical Capacity is the ability to perform bodily activities such as walking, dressing,
bathing, grooming, etc.
Cognitive Development: (Complete for recipients 18 years of age or younger.) Select the
choice that best describes the recipient's cognitive development at the time of listing.
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 18 years of age or younger.) Select the choice
that best describes the recipient's motor development at the time of listing.
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 19 years of age or older.) If the recipient is
working for income just prior to the time of transplant, select Yes. If not, select No. If unknown,
select UNK.
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
If No, Not Working Due To: If No is selected, indicate the reason why the recipient is not
working at the time of listing. (This field is optional for adult recipients only.)
Disability - A physical or mental impairment that interferes with or prevents a recipient
from working (e.g. arthritis, mental retardation, cerebral palsy, etc).
Demands of Treatment - An urgent medical treatment that prevents a recipient from
working (e.g. Dialysis).
Insurance Conflict - Any differences between a recipient 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 recipient who chooses to manage their own
household, instead of performing work for pay.
Patient Choice - Student Full Time/Part Time - A recipient who is enrolled and/or
participating in college.
Patient Choice - Retired - A recipient 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 recipient
from working.
Not Applicable - Hospitalized - Select only if the patient's Medical Condition indicates
they are in the hospital.
Unknown
Academic Progress: (Complete for recipients 18 years of age or younger.) Select the choice
that best describes the recipient's academic progress just prior to the time of transplant.
Within One Grade Level of Peers
Delayed Grade Level
Special Education
Not Applicable <5 years old
Status Unknown
Academic Activity Level: (Complete for recipients 18 years of age or younger.) Select the
choice that best describes the recipient's academic activity level just prior to the time of
transplant. If the recipient is less than 5 years old or has graduated from high school, select Not
Applicable < 5 years old/High School graduate.
Full academic load
Reduced academic load
Unable to participate in academics due to disease or condition
Not Applicable <5 years old/High School graduate
Status Unknown
Source of Payment:
Primary: Select as appropriate to indicate the recipient's source of primary payment
(largest contributor) for the transplant.
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/Choices/Overview.asp.
Public insurance - Medicare & Choice (also known as Medicare Managed Care)
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 (i.e.,
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/Choices/Overview.asp.
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 recipient will pay for the cost of transplant.
Donation indicates that a company, institution, or individual(s) donated funds to pay for
the transplant and care of the recipient.
Free Care indicates that the transplant hospital will not charge recipient for the costs of
the transplant operation.
Foreign Government, Specify refers to funds provided by a foreign government
(Primary only) Specify foreign country in the space provided.
Secondary: Select check as appropriate to indicate the recipient's source of secondary
payment. This field is optional.
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/Choices/Overview.asp.
Public insurance - Medicare & Choice (also known as Medicare Managed Care)
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 (i.e.,
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/Choices/Overview.asp.
Public insurance - CHIP (Children's Health Insurance Program)
Public insurance - Other government
Self indicates that the recipient will pay for the cost of transplant.
Donation indicates that a company, institution, or individual(s) donated funds to pay for
the transplant and care of the recipient.
Free Care indicates that the transplant hospital will not charge the recipient for the
costs of the transplant operation.
None - Select if the recipient does not have a secondary source of payment.
Clinical Information : Pretransplant
Date of Measurement: (Complete for recipients 18 years of age or younger.) Enter the date,
using the 8-digit format of MM/DD/YYYY, the recipient’s height and weight were measured.
Height: Enter the height of the recipient at the time of discharge 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 listing, UNet will generate and display calculated percentiles based on
the 2000 CDC growth charts.
Weight: Enter the weight of the recipient at the time of discharge 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 listing, UNet will generate and display calculated percentiles based on the 2000 CDC
growth charts.
BMI (Body Mass Index): The recipient's BMI will display. For recipients 18 years old or
younger, at the time of listing, 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 5year-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/.
Previous Transplants: The three most recent transplant(s), indicated on the recipient's
validated Transplant Recipient Registration (TRR) record(s), will display. Verify all previous
transplants listed by organ type, transplant date and graft failure date.
Note: The three most recent transplants on record for this recipient will be displayed for
verification. If there are any prior transplants that are not listed here, contact the UNet
Helpdesk at 1-800-978-4334 or [email protected] to determine if the transplant
event is in the database.
Pretransplant Dialysis: If the recipient was on maintenance dialysis before transplant, select
Yes. If not, select No. If unknown, select UNK.
If Yes, Date First Dialyzed: If the recipient was on maintenance dialysis before transplant,
enter the date that the recipient first began dialysis. If the date is unavailable, select the
appropriate status from the ST field (N/A, Not Done, Missing, Unknown).
Average Daily Insulin Units: Enter the recipient's average daily insulin in units. If the value is
unavailable, select the appropriate status from the ST field (N/A, Not Done, Missing,
Unknown).
Serum Creatinine at Time of TX: Enter the serum creatinine at the time of transplant in mg/dl.
If the value is unavailable, select the appropriate status from the ST field (N/A, Not Done,
Missing, Unknown).
Viral Detection:
HIV Serostatus: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: Human Immunodeficiency Virus - Any of several retroviruses and especially
HIV-1 that infect and destroy helper T cells of the immune system causing the marked
reduction in their numbers that is diagnostic of AIDS.
CMV IgG: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: Cytomegalovirus - A herpesvirus (genus Cytomegalovirus) that causes
cellular enlargement and formation of eosinophilic inclusion bodies especially in the
nucleus and that acts as an opportunistic infectious agent in immunosuppressed
conditions (as AIDS).

CMV IgM: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: Cytomegalovirus - A herpesvirus (genus Cytomegalovirus) that causes
cellular enlargement and formation of eosinophilic inclusion bodies especially in the
nucleus and that acts as an opportunistic infectious agent in immunosuppressed
conditions (as AIDS).
HBV Core Antibody: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: Hepatitis B Virus - A sometimes fatal hepatitis caused by a double-stranded
DNA virus (genus Orthohepadnavirus of the family Hepadnaviridae) that tends to
persist in the blood serum and is transmitted especially by contact with infected blood
(as by transfusion or by sharing contaminated needles in illicit intravenous drug use) or
by contact with other infected bodily fluids (as during sexual intercourse) -- also called
serum hepatitis.
HBV Surface Antigen: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: Hepatitis B Virus - A sometimes fatal hepatitis caused by a double-stranded
DNA virus (genus Orthohepadnavirus of the family Hepadnaviridae) that tends to
persist in the blood serum and is transmitted especially by contact with infected blood
(as by transfusion or by sharing contaminated needles in illicit intravenous drug use) or
by contact with other infected bodily fluids (as during sexual intercourse) -- also called
serum hepatitis.
HCV Serostatus: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: Hepatitis C Virus - A disease caused by a flavivirus that is usually
transmitted by parenteral means (as injection of an illicit drug, blood transfusion, or
exposure to blood or blood products) and that accounts for most cases of non-A, non-B
hepatitis.
EBV Serostatus: Select the serology results from the drop-down list.
Positive
Negative
Not Done
UNK/Cannot Disclose
Definition: (Epstein-Barr Virus) - A herpesvirus (genus Lymphocryptovirus) that causes
infectious mononucleosis and is associated with Burkitt's lymphoma and
nasopharyngeal carcinoma -- abbreviation EBV; called also EB virus.

Malignancies between listing and transplant: If recipient had any malignancies between
listing and transplant, select Yes. If the recipient has not had any malignancies, select No. If
Yes is selected, indicate type of malignancy. If the recipient had a malignancy, but the type of
malignancy is not listed, select Other, specify and enter the name of the malignancy in the
space provided.
Skin Melanoma
Skin Non-Melanoma
CNS Tumor
Genitourinary
Breast
Thyroid
Tongue/Throat/Larynx
Lung
Leukemia/Lymphoma
Liver
Other, specify
Note: This question is NOT applicable for patients receiving living donor transplants who
were never on the waiting list.
Clinical Information : Transplant Procedure
Multiple Organ Recipient: If the recipient received other organs, reported on the Recipient
Feedback, they will display. If the recipient didn't receive any other organs at this time, None is
displayed. Verify the other organs, transplanted at this time, are correct. If incorrect, contact the
Help Desk.
Were extra vessels used in the tx procedure: If extra vessels (vascular allografts) were used
in the transplant procedure, as indicated on the Waitlist Removal, YES displays.
Vessel Donor ID: The Donor ID entered on the Waitlist Removal displays.
Note: If the extra vessels used in a transplant procedure are procured from a tissue
processing organization, they are not reported in UNet.
Procedure Type: The procedure type, reported in the Recipient Feedback, will display. Verify
the information displayed in the Procedure Type field is correct.
Pancreas segment
Whole pancreas with duodenum
Whole pancreas with duodenal patch
Whole pancreas
Surgical Information:
If a simultaneous Tx with another organ, was the Pancreas revascularized before or
after other organs? Indicate if the pancreas was revascularized. If this surgery did not
include a simultaneous transplant with another organ, select Not Applicable. This field is
optional.
Before
Simultaneous
After
Not Applicable
Surgical Incision: Indicate the type of surgical incision. This field is optional.
Midline: Incision follows the midline of the abdomen.
Right
Left
Other

Graft Placement: Indicate where the graft was placed during the transplant operation.
Intra-Peritoneal: Pancreas graft placed totally within the peritoneal cavity.
Retro-Peritoneal: Pancreas graft placed totally behind the peritoneum (extra
peritoneal).
Partial Intra/Retro-Peritoneal: Pancreas placed retroperitoneally with the peritoneum
then opened.
Operative Technique: Indicate the type of pancreas transplant.
Pancreas Alone: The recipient only received a pancreas.
Cluster: The recipient received a pancreas with a least a whole liver. Other organs
could also have been transplanted.
Multi-Organ Non-Cluster: The recipient received a pancreas with any other organ(s)
excluding kidney and liver.
Pancreas After Kidney
Pancreas with Kidney Different Donor
Duct Management: Indicate the type of duct management used to manage the exocrine
pancreatic functions.
Enteric with Roux-en-y: The pancreatic duct is allowed to drain into the small intestine
using a Roux-en-y.
Enteric without Roux-en-y: The pancreatic duct is allowed to drain into the small
intestine without using a Roux-en-y.
Cystostomy: The pancreatic duct is allowed to drain into the bladder.
Duct Injection Immediate: A synthetic polymer is injected directly into the pancreatic
duct immediately after surgical revascularization.
Duct Injection Delayed: The duct is left open for a period up to 30 days before a
synthetic polymer is injected directly into the pancreatic duct.
Other Specify: If a type of duct management used is not listed, select Other and enter
the type of duct management in the space provided.
Venous Vascular Management: Indicate which venous system (systemic or portal) was
used to attach the pancreas.
Systemic System (Iliac:Cava)
Portal System (Portal or Tributaries)
NA/Multi-organ cluster
Arterial Reconstruction: Indicate the type of arterial reconstruction used in the transplant
operation.
Celiac Axis with Pancreas: The celiac axis remained attached to the pancreas and
reconstruction of the artery was not necessary.
Y-Graft to SpA and SMA: The splenic artery (SpA) and the superior mesenteric artery
(SMA) were attached via an arterial graft.
SpA Alone: The splenic artery alone.
SpA to SMA Direct: The splenic artery was anastomosed end-to-side to the superior
mesenteric artery.
SpA to SMA with Interposition: The splenic artery was attached to the superior
mesenteric artery with an interposition graft.
Other: If the type of arterial reconstruction is not listed, select Other and enter the type
of reconstruction used in the space provided.
Venous Extension Graft: If a venous extension graft was used to lengthen the portal or
splenic vein of the pancreas graft, select Yes. If not, select No.

Preservation Information: The preservation information for the pancreas procedure type is
displayed for the recipient. Enter the Total Pancreas Preservation Time, in hours, for the
pancreas procedure.
Total Pancreas Preservation Time (Include cold, warm and anastomotic time) is the
time between cessation of blood flow in the donor and revascularization of the pancreas in
the recipient. If the time is unavailable, select the appropriate status from the ST field (N/A,
Not Done, Missing, Unknown).
Note: Enter the time in hours and decimal parts of an hour. For example, 1 hour should be
entered as "1", "1.0" or "1.00"; 1 hour and 30 minutes should be entered as "1.5" or
"1.50" not "1.30".
Clinical Information : Post Transplant
Pancreas Graft Status: Select the status that best describes the pancreas graft status.
Note: Select Functioning for the Pancreas Graft Status field if the patient was removed
from the waiting list with a code 21, indicating the patient died during the transplant
procedure.
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 medication for blood sugar control.
Partial Function: The patient is taking some insulin, but < 50% of the usual amount taken
before transplant, or C-Peptide is present.
Failed: The graft has totally failed and the patient is completely dependent upon insulin or
oral medication for blood sugar control.
If Partial Function or Failed is selected, indicate Method of blood sugar control:
Check all that apply.
Insulin
Oral medication
Diet
No Treatment
Date insulin/medication resumed: If Insulin or Oral medication is selected,
enter the date using the standard 8 digit numeric format of MM/DD/YYYY.
If Failed is selected, complete the following fields:
Date of Graft Failure Pancreas: If the pancreas graft failed, enter the date of the
failure.
Note: The date of failure and the date insulin/medication was resumed should
be the same, unless the patient has a previous partial graft function
reported.
Pancreas Graft Removed: If the pancreas graft had been removed, select Yes. If
not, select No. If unknown, select UNK. This field is optional.
If Yes, Date Pancreas Graft Removed: If the pancreas graft had been
removed, enter the date of removal. This field is optional.
Pancreas Primary Cause of Graft Failure: Select the primary cause of graft
failure. If the primary cause of graft failure is not listed, select Other Specify and
enter the primary cause of graft failure in the space provided.

Graft/Vascular Thrombosis
Infection
Bleeding
Anastomotic Leak
Primary Non-Function
Acute Rejection
Hyperacute Rejection
Biopsy Proven Isletitis
Pacreatitis
Other Specify
Contributory causes of graft failure: For each of the causes listed, select Yes,
No, or Unknown to indicate whether each is a contributory cause of graft failure.
Select No for the primary cause, since it cannot be both the primary and secondary
cause of graft failure. If Other is selected, specify the cause in the space provided.
Pancreas Graft/Vascular Thrombosis
Pancreas Infection
Bleeding
Anastomotic Leak
Hyperacute Rejection
Pancreas Acute Rejection
Biopsy Proven Isletits
Pancreatitis
Other
Pancreas Transplant Complications: (Not leading to graft failure.) For each of the
complications listed, indicate if the complication occurred prior to the recipient's hospital
discharge. Do not select Yes if the complication contributed to failure of the pancreas graft.
Pancreatitis: If the recipient has been diagnosed as having pancreatitis, select Yes. If not,
select No. If unknown, select UNK.
Anastomotic Leak: If the recipient exhibits signs and symptoms of an anastomotic leak,
select Yes. If not, select No. If unknown, select UNK.
Abscess or Local Infection: If the recipient exhibits signs and symptoms of abscess or
local infection, select Yes. If not, select No. If unknown, select UNK.
Other: If a complication other than those listed occurred, specify the complication in the
space provided.
Did patient have any acute rejection episodes between transplant and discharge: If the
recipient had any acute rejection episodes between transplant and discharge, select a Yes
choice. If not, select No. If a Yes choice is selected, then indicate if a biopsy was done to
confirm acute rejection.
Yes, at least one episode treated with anti-rejection agent
Yes, none treated with additional anti-rejection agent
No
Was Biopsy done to confirm acute rejection: If the recipient had an acute kidney
rejection episode, indicate whether biopsy confirmed acute rejection by selecting Yes. If a
biopsy was not done, select Biopsy not done. If unknown, select Unknown. This field is
optional.
Biopsy not done
Yes, rejection confirmed
Yes, rejection not confirmed
Treatment

Biological or Anti-viral Therapy: If biological or anti-viral therapy is being administered to the
recipient, select Yes. If not, select No. If unknown or can't disclose, select Unknown/Cannot
Disclose. If Yes is selected, check all that apply. If a therapy, other than those listed, was
administered, select Other, Specify and enter the therapy in the space provided. These fields
are optional.
Acyclovir (Zovirax)
Cytogam (CMV)
Gamimune
Gammagard
Ganciclovir (Cytovene)
Valgancyclovir (Valcyte)
HBIG (Hepatitis B Immune Globulin)
Flu Vaccine (Influenza Virus)
Lamivudine (Epivir) (for treatment of Hepatitis B)
Valacyclovir (Valtrex)
Other, Specify
Other Therapies: If the recipient received other therapies, select Yes. If not, select No. If Yes
is selected, check all that apply. These fields are optional.
Photopheresis
Plasmapheresis
Total Lymphoid Irradiation (TLI)
Note: If the recipient was removed from the waiting list with a code 21, indicating the recipient
died during the transplant procedure, select No for all Biologicals or Anti-viral.
Immunosuppressive Information
Are any medications given currently for maintenance or anti-rejection: If medications have
been given to the recipient for maintenance or anti-rejection during the time between transplant
and hospital discharge, or 6 weeks post-transplant if the recipient has not been discharged,
select Yes. If not, select No. If Yes, complete the sections below.
Did the recipient participate in any clinical research protocol for immunosuppressive
medications: If the recipient participated in clinical research for immunosuppressive
medications, select Yes. If not, select No. If Yes, specify in the space provided. These fields
are optional.
Immunosuppressive Medications
For each of the immunosuppressive medications listed, select Ind. (Induction), Maint
(Maintenance) or AR (Anti-rejection) to indicate all medications that were prescribed for the
recipient during the initial transplant hospitalization period, and for what reason. If a medication
was not given, leave the associated box blank.
Induction (Ind.) immunosuppression includes all medications given for a short finite period
in the perioperative period for the purpose of preventing acute rejection. Though the drugs
may be continued after discharge for the first 30 days after transplant, it will not be used
long-term for immunosuppressive maintenance. Induction agents are usually polyclonal,
monoclonal, or IL-2 receptor antibodies (e.g., Methylprednisolone, Atgam, Thymoglobulin,
OKT3, Simulect, or Zenapax). Some of these drugs might be used for another finite period
for rejection therapy and would be recorded as rejection therapy if used for this reason. For
each induction medication indicated, enter the total number of days the drug was actually
administered in the space provided. For example, if Simulect or Zenapax was given in 2
doses a week apart then the total number of days would be 2, even if the second dose was
given after the patient was discharged.

Maintenance (Maint) includes all immunosuppressive medications given before, during or
after transplant 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, or for induction.
Anti-rejection (AR) immunosuppression includes all immunosuppressive medications
given for the purpose of treating an acute rejection episode during the initial post-transplant
period or during a specific follow-up period, usually up to 30 days after the diagnosis of
acute rejection (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: 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 Ind., 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.
If the number of days is unavailable, select the appropriate status from the applicable Status
field (N/A, Not Done, Missing, Unknown).
Other Immunosuppressive Medications
For each of the immunosuppressive medications listed, select Ind. (Induction), Maint
(Maintenance) or AR (Anti-rejection) to indicate all medications that were prescribed for the
recipient during the initial transplant hospitalization period, and for what reason. If a medication
was not given, leave the associated box blank.
Induction (Ind.) immunosuppression includes all medications given for a short finite period
in the perioperative period for the purpose of preventing acute rejection. Though the drugs
may be continued after discharge for the first 30 days after transplant, it will not be used
long-term for immunosuppressive maintenance. Induction agents are usually polyclonal,
monoclonal, or IL-2 receptor antibodies (e.g., Methylprednisolone, Atgam, Thymoglobulin,
OKT3, Simulect, or Zenapax). Some of these drugs might be used for another finite period
for rejection therapy and would be recorded as rejection therapy if used for this reason. For
each induction medication indicated, enter the total number of days the drug was actually
administered in the space provided. For example, if Simulect or Zenapax was given in 2
doses a week apart then the total number of days would be 2, even if the second dose was
given after the patient was discharged.
Maintenance (Maint) includes all immunosuppressive medications given before, during or
after transplant 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, or for induction.

Anti-rejection (AR) immunosuppression includes all immunosuppressive medications
given for the purpose of treating an acute rejection episode during the initial post-transplant
period or during a specific follow-up period, usually up to 30 days after the diagnosis of
acute rejection (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: 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 Ind., 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.
If the number of days is unavailable, select the appropriate status from the applicable Status
field (N/A, Not Done, Missing, Unknown).
Investigational Immunosuppressive Medications
For each of the immunosuppressive medications listed, select Ind. (Induction), Maint
(Maintenance) or AR (Anti-rejection) to indicate all medications that were prescribed for the
recipient during the initial transplant hospitalization period, and for what reason. If a medication
was not given, leave the associated box blank.
Induction (Ind.) immunosuppression includes all medications given for a short finite period
in the perioperative period for the purpose of preventing acute rejection. Though the drugs
may be continued after discharge for the first 30 days after transplant, it will not be used
long-term for immunosuppressive maintenance. Induction agents are usually polyclonal,
monoclonal, or IL-2 receptor antibodies (example: Methylprednisolone, Atgam,
Thymoglobulin, OKT3, Simulect, or Zenapax). Some of these drugs might be used for
another finite period for rejection therapy and would be recorded as rejection therapy if
used for this reason. For each induction medication indicated, enter the total number of
days the drug was actually administered in the space provided. For example, if Simulect or
Zenapax was given in 2 doses a week apart then the total number of days would be 2,
even if the second dose was given after the patient was discharged.
Maintenance (Maint) includes all immunosuppressive medications given before, during or
after transplant 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, or for induction.
Anti-rejection (AR) immunosuppression includes all immunosuppressive medications
given for the purpose of treating an acute rejection episode during the initial post-transplant
period or during a specific follow-up period, usually up to 30 days after the diagnosis of
acute rejection (example: Methylprednisolone, Atgam, OKT3, or Thymoglobulin). When
switching maintenance drugs (example: 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: 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 Ind., 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.
If the number of days is unavailable, select the appropriate status from the applicable Status
field (N/A, Not Done, Missing, Unknown).
Drug Codes
Sandimmune (Cyclosporine A)
Neoral (CyA-NOF)
Tacrolimus (Prograf, FK506)
Sirolimus (RAPA, Rapamycin, Rapamune)
Leflunomide (LFL, Arava)
Azathioprine (AZA, Imuran)
Mycophenolate Mofetil (MMF, Cellcept, RS61443)
Cyclophosphamide (Cytoxan)
Methotrexate (Folex, PFS, Mexate-AQ, Rheumatrex)
Atgam (ATG)
OKT3 (Orthoclone, Muromonab)
Thymoglobulin
Zenapax - Daclizumab
Simulect - Basiliximab
Gengraf (Abbott Cyclosporine)
Everolimus (RAD, Certican)
EON (Generic Cyclosporine)
Myfortic (Mycophenolate Sodium)
Other generic Cyclosporine, specify brand:
Steroids (Prednisone,Methylprednisolone,Solumedrol,Medrol,Decadron)
Campath - Alemtuzumab (anti-CD52)
FTY 720
Rituximab
Modified Release Tacrolimus FK506E (MR4)
Other Immunosuppressive Medication, Specify
Other Immunosuppressive Medication, Specify


File Typeapplication/pdf
File TitleTRR - Pancreas
Authorpritchdh
File Modified2007-03-27
File Created2007-03-27

© 2024 OMB.report | Privacy Policy