Pancreas Transplant Recipient Follow Up 6 Month_5 Year_Form_redline.xlsx

TRF - Pancreas - Adult					TRF - Pancreas - Pediatric
Fields to be completed by members					Fields to be completed by members
Form Section	Field label	Notes		Form Section	Field label	Notes
Recipient Information	Organ Type	Display Only - Cascades from Database		Recipient Information	Organ Type	Display Only - Cascades from Database
Recipient Information	Follow-up code	Display Only - Cascades from Database		Recipient Information	Follow-up code	Display Only - Cascades from Database
Recipient Information	Recipient First Name	Display Only - Cascades from TCR		Recipient Information	Recipient First Name	Display Only - Cascades from TCR
Recipient Information	Recipient Last Name	Display Only - Cascades from TCR		Recipient Information	Recipient Last Name	Display Only - Cascades from TCR
Recipient Information	Recipient Middle Initial	Display Only - Cascades from TCR		Recipient Information	Recipient Middle Initial	Display Only - Cascades from TCR
Recipient Information	SSN	Display Only - Cascades from TCR		Recipient Information	SSN	Display Only - Cascades from TCR
Recipient Information	HIC	Display Only - Cascades from TCR		Recipient Information	HIC	Display Only - Cascades from TCR
Recipient Information	Previous Follow-up	Display Only - Cascades from prior TRF		Recipient Information	Previous Follow-up	Display Only - Cascades from prior TRF
Recipient Information	DOB	Display Only - Cascades from TCR		Recipient Information	DOB	Display Only - Cascades from TCR
Recipient Information	Gender	Display Only - Cascades from TCR		Recipient Information	Gender	Display Only - Cascades from TCR
Recipient Information	Tx Date	Display Only - Cascades from Database		Recipient Information	Tx Date	Display Only - Cascades from Database
Recipient Information	Previous Px Stat Date	Display Only - Cascades from prior TRF		Recipient Information	Previous Px Stat Date	Display Only - Cascades from prior TRF
Recipient Information	Transplant Discharge Date			Recipient Information	Transplant Discharge Date
Recipient Information	State of Permanent Residence			Recipient Information	State of Permanent Residence
Recipient Information	Zip Code			Recipient Information	Zip Code
Provider Information	Recipient Center	Display Only - Cascades from TCR		Provider Information	Recipient Center	Display Only - Cascades from TCR
Provider Information	Recipient Center Type	Display Only - Cascades from TCR		Provider Information	Recipient Center Type	Display Only - Cascades from TCR
Provider Information	Follow-up Center Code	Display Only - Cascades from Database		Provider Information	Follow-up Center Code	Display Only - Cascades from Database
Provider Information	Follow-up Center Type	Display Only - Cascades from Database		Provider Information	Follow-up Center Type	Display Only - Cascades from Database
Provider Information	Physician Name			Provider Information	Physician Name
Provider Information	NPI#			Provider Information	NPI#
Provider Information	Follow-up Care Provided By			Provider Information	Follow-up Care Provided By
Provider Information	Follow-up Care Provided By//Specify			Provider Information	Follow-up Care Provided By//Specify
Donor Information	UNOS Donor ID #	Display Only - Cascades from Database		Donor Information	UNOS Donor ID #	Display Only - Cascades from Database
Donor Information	Donor Type	Display Only - Cascades from Database		Donor Information	Donor Type	Display Only - Cascades from Database
Donor Information	OPO	Display Only - Cascades from feedback		Donor Information	OPO	Display Only - Cascades from feedback
Patient Status	Date: Last Seen, Retransplanted or Death			Patient Status	Date: Last Seen, Retransplanted or Death
Patient Status	Patient Status			Patient Status	Patient Status
Patient Status	Primary Cause of Death			Patient Status	Primary Cause of Death
Patient Status	Primary Cause of Death//Specify			Patient Status	Primary Cause of Death//Specify
Patient Status	Contributory Cause of Death	Not required		Patient Status	Contributory Cause of Death	Not required
Patient Status	Contributory Cause of Death//Specify	Not required		Patient Status	Contributory Cause of Death//Specify	Not required
Patient Status	Contributory Cause of Death	Not required		Patient Status	Contributory Cause of Death	Not required
Patient Status	Contributory Cause of Death//Specify	Not required		Patient Status	Contributory Cause of Death//Specify	Not required
Patient Status	Has the patient been hospitalized since the last patient status date			Patient Status	Has the patient been hospitalized since the last patient status date
Patient Status	Functional Status			Patient Status	Functional Status
Patient Status	Working for income			Patient Status at Time of Follow-up	Cognitive Development
Patient Status	Primary Insurance at Follow-up			Patient Status at Time of Follow-up	Motor Development
Patient Status	Primary Source of Payment, Specify			Patient Status	Working for income
Clinical Information	Weight			Patient Status	Academic Progress
Clinical Information	Weight//Status	Value or status is reported, not both		Patient Status	Academic Activity Level
Clinical Information	HIV Serology			Patient Status	Primary Insurance at Follow-up
Clinical Information	HIV NAT			Clinical Information	Date of Measurement
Clinical Information	HbsAg			Clinical Information	Height Measurement Date
Clinical Information	HBV DNA			Clinical Information	Height
Clinical Information	HBV Core Antibody			Clinical Information	Height//Status	Value or status is reported, not both
Clinical Information	HCV Serology			Clinical Information	Height Percentile	Calculated for display only
Clinical Information	HCV NAT			Clinical Information	Weight Measurement Date
Clinical Information	Graft Status			Clinical Information	Weight
Clinical Information	Patient using any method of blood sugar control?			Clinical Information	Weight//Status	Value or status is reported, not both
Clinical Information	Patient on insulin?	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.		Clinical Information	Weight Percentile	Calculated for display only
Clinical Information	Date insulin resumed	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.		Clinical Information	BMI	Display Only - Cascades from Database
Clinical Information	Date insulin resumed//ST=	Value or status is reported, not both		Clinical Information	BMI Percentile	Calculated for display only
Clinical Information	Total insulin dosage units			Clinical Information	HIV Serology
Clinical Information	Total insulin dosage units//ST	Value or status is reported, not both		Clinical Information	HIV NAT
Clinical Information	Insulin duration of use			Clinical Information	HbsAg
Clinical Information	Insulin duration of use//ST	Value or status is reported, not both		Clinical Information	HBV DNA
Clinical Information	Patient on oral medication to control blood sugar	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.		Clinical Information	HBV Core Antibody
Clinical Information	Date oral medications resumed	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.		Clinical Information	HCV Serology
Clinical Information	Date oral medications resumed//ST=	Value or status is reported, not both		Clinical Information	HCV NAT
Clinical Information	Patient using diet to control blood sugar	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.		Clinical Information	Graft Status
Clinical Information	Date of Graft Failure			Clinical Information	Patient using any method of blood sugar control?
Clinical Information	C-Peptide Value			Clinical Information	Patient on insulin?	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.
Clinical Information	C-Peptide Value://ST=	Value or status is reported, not both		Clinical Information	Date insulin resumed	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.
Clinical Information	Hba1c (%)			Clinical Information	Date insulin resumed//ST=	Value or status is reported, not both
Clinical Information	Hba1c (%)//Status	Value or status is reported, not both		Clinical Information	Total insulin dosage units
Clinical Information	Primary Cause of Graft Failure			Clinical Information	Total insulin dosage units//ST	Value or status is reported, not both
Clinical Information	Primary Cause of Graft Failure//Other, Specify			Clinical Information	Insulin duration of use
Clinical Information	Graft/Vascular Thrombosis			Clinical Information	Insulin duration of use//ST	Value or status is reported, not both
Clinical Information	Infection			Clinical Information	Patient on oral medication to control blood sugar	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.
Clinical Information	Bleeding			Clinical Information	Date oral medications resumed	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.
Clinical Information	Anastomotic Leak			Clinical Information	Date oral medications resumed//ST=	Value or status is reported, not both
Clinical Information	Acute Rejection			Clinical Information	Patient using diet to control blood sugar	New field if pancreas graft status is functioning. Modification to current label if graft status is failed.
Clinical Information	Chronic Rejection			Clinical Information	Date of Graft Failure
Clinical Information	Biopsy Proven Isletitis			Clinical Information	C-Peptide Value
Clinical Information	Pancreatitis			Clinical Information	C-Peptide Value://ST=	Value or status is reported, not both
Clinical Information	Patient Noncompliance			Clinical Information	Hba1c (%)
Clinical Information	Contributory Cause of Graft Failure//Other, Specify			Clinical Information	Hba1c (%)//Status	Value or status is reported, not both
Clinical Information	Conv. From Bladder to Enteric Drain Performed			Clinical Information	Primary Cause of Graft Failure
Clinical Information	If Yes, Enteric Drainage Date			Clinical Information	Primary Cause of Graft Failure//Other, Specify
Clinical Information	Most Recent Serum Creatinine			Clinical Information	Graft/Vascular Thrombosis
Clinical Information	Most Recent Serum Creatinine//Status	Value or status is reported, not both		Clinical Information	Infection
Clinical Information	Pancreas Transplant Complications (Not leading to graft failure)	Display Only - Cascades from Database		Clinical Information	Bleeding
Clinical Information	Pancreatitis			Clinical Information	Anastomotic Leak
Clinical Information	Anastomotic Leak			Clinical Information	Acute Rejection
Clinical Information	Abscess or Local Infection			Clinical Information	Chronic Rejection
Clinical Information	Other Complications			Clinical Information	Biopsy Proven Isletitis
Clinical Information	Did patient have any acute rejection episodes during the follow-up period			Clinical Information	Pancreatitis
Clinical Information	Post Transplant Malignancy			Clinical Information	Patient Noncompliance
Clinical Information	Donor Related			Clinical Information	Contributory Cause of Graft Failure//Other, Specify
Clinical Information	Recurrence of Pre-Tx Tumor			Clinical Information	Conv. From Bladder to Enteric Drain Performed
Clinical Information	De Novo Solid Tumor			Clinical Information	If Yes, Enteric Drainage Date
Clinical Information	De Novo Lymphoproliferative disease and Lymphoma			Clinical Information	Most Recent Serum Creatinine
Immunosuppressive Information	Were any medications given during the follow-up period for maintenance			Clinical Information	Most Recent Serum Creatinine//Status	Value or status is reported, not both
Immunosuppressive Information	Previous Validated Maintenance Follow-up Medications	Display Only - Cascades from Database		Clinical Information	Pancreas Transplant Complications (Not leading to graft failure)	Display Only - Cascades from Database
Immunosuppressive Information	Immunosuppression medication			Clinical Information	Pancreatitis
Immunosuppressive Information	Immunosuppression medication indication			Clinical Information	Anastomotic Leak
				Clinical Information	Abscess or Local Infection
				Clinical Information	Other Complications
PUBLIC BURDEN STATEMENT:				Clinical Information	Did patient have any acute rejection episodes during the follow-up period
The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0157 and it is valid until XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 0.27 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or paperwork@hrsa.gov.				Clinical Information	Post Transplant Malignancy
				Clinical Information	Donor Related
				Clinical Information	Recurrence of Pre-Tx Tumor
				Clinical Information	De Novo Solid Tumor
				Clinical Information	De Novo Lymphoproliferative disease and Lymphoma
				Immunosuppressive Information	Were any medications given during the follow-up period for maintenance
				Immunosuppressive Information	Previous Validated Maintenance Follow-up Medications	Display Only - Cascades from Database
				Immunosuppressive Information	Immunosuppression medication
				Immunosuppressive Information	Immunosuppression medication indication
				PUBLIC BURDEN STATEMENT:
				The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0157 and it is valid until XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 0.27 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or paperwork@hrsa.gov.