Kidney Candidate Registration Changes

TCR All Organs Doc.pdf

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

Kidney Candidate Registration Changes

OMB: 0915-0157

Document [pdf]
Download: pdf | pdf
2007 Transplant Candidate Registration Changes for OMB Clearance

ORGAN
All

SECTION
Candidate
Information

FIELD
Physical Capacity

MODIFICATION/ADDITION

RATIONALE

For pediatric patients replace with:
Additional data necessary to develop transplant policies.
Cognitive Development with choices:
• 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

Page 1 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

All

All

SECTION

Clinical
Information
Listing
Candidate
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Physical Capacity

For pediatric patients replace with:
Additional data necessary to develop transplant policies.
Motor Development with choices:
• 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
behaviors observation or other
evidence)
• Questionable Motor
delay/impairment (not judged to be
more likely than not, but with
some indications of motor
delay/impairment)
• No Motor delay/impairment (no
obvious indicators of motor
delay/impairment)
• Not Assessed

New

For pediatric candidates add Date of
Measurement for Height and Weight.

at

Additional data necessary to develop transplant policies.

Is patient waiting in This question will be optional for adult No longer necessary.
permanent ZIP code and pediatric candidates.

All

Medical condition at This question will be optional for adult No longer necessary.
time of listing
and pediatric candidates.

All

Physical Capacity

This question will be optional for adult No longer necessary.
candidates.
Page 2 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

All

Reason not working This question will be optional for adult No longer necessary.
for income
candidates.

All

Work status if
working for income

This question will be optional for adult No longer necessary.
candidates.

All

Previous pancreas
islet infusion

This question will be optional for
pediatric candidates.

All

Secondary source of This question will be optional for adult No longer necessary.
payment
and pediatric candidates.

All

General Medical Peptic Ulcer
Factors

Not a common procedure in pediatric patients.

This question will be optional for adult No longer necessary.
and pediatric candidates.

All

Angina

This question will be optional for adult No longer necessary.
and pediatric candidates.

All

Drug treated
systemic
hypertension

This question will be optional for adult No longer necessary.
and pediatric candidates.

Academic activity
level

For pediatric candidates add an option
to pick list Unable to participate
regularly in academics due to dialysis.

Additional data necessary to develop transplant policies.

New

For pediatric candidates add
Is growth hormone therapy used at the
time of listing: Yes/No/Unknown

Additional data necessary to develop transplant policies.

Kidney

Candidate
Information
Clinical
Information
Listing

at

General Medical Dialysis
Factors
Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.
This question will be optional for adult No longer necessary.
and pediatric candidates.

Page 3 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

Pancreas

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Symptomatic
peripheral vascular
disease

This question will be optional for
pediatric candidates.

No longer necessary.

Drug treated COPD

This question will be optional for
pediatric candidates.

No longer necessary.

Most recent serum
creatinine

This question will be optional for adult No longer necessary.
and pediatric candidates.

Kidney Medical New
Factors

For pediatric candidates add
Bone Disease (check all that apply)
• Fracture in the past year:
Yes/No/Unknown
o Specify location and
number of fractures:
o Spine-compression, #
o Extremity, #
o Other, #
• AVN (avascular necrosis):
Yes/No/Unknown

General Medical Dialysis
Factors

This question will be optional for adult No longer necessary.
and pediatric candidates.

Additional data necessary to develop transplant policies.

Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
peripheral vascular
disease

This question will be optional for
pediatric candidates.

No longer necessary.

Drug treated COPD

This question will be optional for
pediatric candidates.

No longer necessary.

Page 4 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

Kidney/Pancreas Candidate
Information
Clinical
Information
Listing

MODIFICATION/ADDITION

RATIONALE

Most recent serum
creatinine

This question will be optional for adult No longer necessary.
and pediatric candidates.

Academic activity
level

For pediatric candidates add an option
to pick list Unable to participate
regularly in academics due to dialysis.

Additional data necessary to develop transplant policies.

New

For pediatric candidates add
Is growth hormone therapy used at the
time of listing: Yes/No/Unknown

Additional data necessary to develop transplant policies.

at

General Medical Dialysis
Factors

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
peripheral vascular
disease

This question will be optional for
pediatric candidates.

No longer necessary.

Drug treated COPD

This question will be optional for
pediatric candidates.

No longer necessary.

For pediatric candidates add
Bone Disease (check all that apply)
• Fracture in the past year:
Yes/No/Unknown
o Specify location and
number of fractures:
o Spine-compression, #
o Extremity, #
o Other, #
• AVN (avascular necrosis):
Yes/No/Unknown

Additional data necessary to develop transplant policies.

Kidney/Pancreas New
Medical Factors

Page 5 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN
Liver

SECTION

FIELD

General Medical Dialysis
Factors

MODIFICATION/ADDITION

RATIONALE

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
peripheral vascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Drug treated COPD

This question will be optional for adult No longer necessary.
and pediatric candidates.

Pulmonary
embolism

This question will be optional for adult No longer necessary.
and pediatric candidates.

Any previous
malignancy type

For pediatric candidates add options to Additional data necessary to develop transplant policies.
the pick list for Hepatoblastoma and
Hepatocellular Carcinoma.

Most recent serum
creatinine

This question will be optional for adult No longer necessary.
and pediatric candidates.

Liver
Medical Variceal bleeding
This question will be optional for adult No longer necessary.
Factors
with last two weeks. and pediatric candidates.
Intestine

General Medical Dialysis
Factors

This question will be optional for adult No longer necessary.
and pediatric candidates.

Secondary diagnosis This question will be optional for adult No longer necessary.
and pediatric candidates.
Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Page 6 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Symptomatic
peripheral vascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Drug treated COPD

This question will be optional for adult No longer necessary.
and pediatric candidates.

Pulmonary
embolism

This question will be optional for adult No longer necessary.
and pediatric candidates.

Any previous
malignancy type

For pediatric candidates add options to Additional data necessary to develop transplant policies.
the pick list for Hepatoblastoma and
Hepatocellular Carcinoma.

Most recent serum
creatinine

This question will be optional for adult No longer necessary.
and pediatric candidates.

Total serum albumin This question will be optional for adult No longer necessary.
and pediatric candidates.
Intestine Medical Exhausted vascular
Factors
access

This question will be optional for adult No longer necessary.
candidates.
For pediatric candidates this question
will be modified to: Loss of 2 or more
vascular access sites.

Liver dysfunction

This question will be optional for adult Additional data necessary to develop transplant policies.
candidates.
For pediatric candidates replace with
Total Bilirubin.

Intestine neoplasm

This question will be optional for adult No longer necessary.
and pediatric candidates.

History of portal
vein thrombosis

This question will be optional for adult Clarify information already presented.
candidates.
Modify to History of portomesenteric
vein thrombosis.
Page 7 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

Heart

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

History of TIPSS

This question will be optional for adult No longer necessary.
and pediatric candidates.

New

For pediatric candidates add Variceal
bleeding in the last 2 weeks:
Yes/No/Unknown.

New

For pediatric candidates add Recurrent Additional data necessary to develop transplant policies.
sepsis: Yes/No/Unknown.

New

For pediatric candidates add Fungal
sepsis: Yes/No/Unknown.

New

For pediatric candidates add
Additional data necessary to develop transplant policies.
Unmanageable fluid-electrolyte losses:
Yes/No/Unknown.

New

For pediatric candidates add “Nonreconstructible” GI tract:
Yes/No/Unknown.

General Medical Symptomatic
Factors
peripheral vascular
disease

Additional data necessary to develop transplant policies.

Additional data necessary to develop transplant policies.

Additional data necessary to develop transplant policies.

This question will be optional for adult No longer necessary.
and pediatric candidates.

Drug treated COPD

This question will be optional for adult No longer necessary.
and pediatric candidates.

Pulmonary
embolism

This question will be optional for adult No longer necessary.
and pediatric candidates.

Any previous
transfusions

This question will be optional for adult No longer necessary.
and pediatric candidates.

Total serum albumin This question will be optional for adult No longer necessary.
candidates.
Heart
Medical Sudden death
Factors

This question will be optional for adult No longer necessary.
candidates.
Page 8 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Antiarrhythmics

This question will be optional for adult No longer necessary.
and pediatric candidates.

Amiodarone

This question will be optional for adult No longer necessary.
and pediatric candidates.

Infection requiring
IV drug therapy
within 2/wks prior
to listing

This question will be optional for adult No longer necessary.
and pediatric candidates.

History of cigarette
use – pack years

This question will be optional for adult No longer necessary.
and pediatric candidates.

Other tobacco use

This question will be optional for adult No longer necessary.
and pediatric candidates.

Page 9 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Prior cardiac surgery
(nontransplant)
check all that apply
Prior lung surgery
(nontransplant)
check all that apply

For pediatric candidates replace
• CABG
• Valve Replacement/Repair
• Congenital
• Left Ventricular Remodeling
• Other, specify
• Pneumoreduction
• Pneumothorax Surgery-Nodule
• Pneumothorax Decortication
• Lobectomy
• Pneumonectomy
• Left Thoracotomy
• Right Thoracotomy
• Other, specify
With Prior thoracic surgery other than
previous transplant:
• If yes, number of prior
sternotomies
• If yes, number of prior
thoracotomies
AND Add
Prior congenital cardiac surgery:
Yes/No/Unknown
• If yes, palliative surgery:
Yes/No/Unknown
If yes, corrective surgery:
Yes/No/Unknown

Prior lung surgery
(nontransplant)
check all that apply

This question will be optional for adult No longer necessary.
candidates.

Page 10 of 16
4/2/2007

Additional data necessary to develop transplant policies
and to determine member specific performance.

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN
Heart/Lung

SECTION
Candidate
Information

FIELD
Life Support

General Medical Dialysis
Factors

MODIFICATION/ADDITION

RATIONALE

For pediatric candidates add and option Additional data necessary to develop transplant policies.
to the pick list for IV Inotropes.
This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
peripheral vascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Drug treated COPD

This question will be optional for adult No longer necessary.
and pediatric candidates.

Pulmonary
embolism

This question will be optional for adult No longer necessary.
and pediatric candidates.

Most recent serum
creatinine

This question will be optional for adult No longer necessary.
and pediatric candidates.

Total serum albumin This question will be optional for adult No longer necessary.
candidates.
Heart
Medical Sudden death
Factors

This question will be optional for adult No longer necessary.
candidates.

Antiarrhythmics

This question will be optional for adult No longer necessary.
and pediatric candidates.

Amiodarone

This question will be optional for adult No longer necessary.
and pediatric candidates.

Infection requiring
IV drug therapy
within 2/wks prior
to listing

This question will be optional for adult No longer necessary.
and pediatric candidates.

Page 11 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Lung
Medical FVC
Factors

This question will be optional for adult No longer necessary.
and pediatric candidates.

FeV1

This question will be optional for adult No longer necessary.
and pediatric candidates.

pCO2

This question will be optional for adult No longer necessary.
and pediatric candidates.

FeV1(L)/FVC(L)

This question will be optional for adult No longer necessary.
and pediatric candidates.

O2 requirement at
rest

This question will be optional for adult No longer necessary.
and pediatric candidates.

IV treated
pulmonary sepsis
episode >= 2 in last
12 months

This question will be optional for adult No longer necessary.
and pediatric candidates.

Corticosteroid
dependency >=
5mg/day

This question will be optional for adult No longer necessary.
and pediatric candidates.

Six minute walk
distance

This question will be optional for adult No longer necessary.
and pediatric candidates.

History of cigarette
use – pack years

This question will be optional for adult No longer necessary.
and pediatric candidates.

Other tobacco use

This question will be optional for adult No longer necessary.
and pediatric candidates.

Heart/Lung
Medical Factors

Page 12 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Prior cardiac surgery
(nontransplant)
check all that apply
Prior lung surgery
(nontransplant)
check all that apply

For pediatric candidates replace
• CABG
• Valve Replacement/Repair
• Congenital
• Left Ventricular Remodeling
• Other, specify
• Pneumoreduction
• Pneumothorax Surgery-Nodule
• Pneumothorax Decortication
• Lobectomy
• Pneumonectomy
• Left Thoracotomy
• Right Thoracotomy
• Other, specify
With Prior thoracic surgery other than
previous transplant:
• If yes, number of prior
sternotomies
• If yes, number of prior
thoracotomies
AND Add
Prior congenital cardiac surgery:
Yes/No/Unknown
• If yes, palliative surgery:
Yes/No/Unknown
If yes, corrective surgery:
Yes/No/Unknown

Prior lung surgery
(nontransplant)
check all that apply

This question will be optional for adult No longer necessary.
candidates.

Page 13 of 16
4/2/2007

Additional data necessary to develop transplant policies
and to determine member specific performance.

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN
Lung

SECTION
Candidate
Information

FIELD
Life Support

General Medical Dialysis
Factors

MODIFICATION/ADDITION

RATIONALE

For pediatric candidates add and option Additional data necessary to develop transplant policies.
to the pick list for IV Inotropes.
This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
cerebrovascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Symptomatic
peripheral vascular
disease

This question will be optional for adult No longer necessary.
and pediatric candidates.

Most recent serum
creatinine

This question will be optional for adult No longer necessary.
and pediatric candidates.

Total serum albumin This question will be optional for adult No longer necessary.
candidates.
Lung
Medical FVC
Factors

This question will be optional for adult No longer necessary.
and pediatric candidates.

FeV1

This question will be optional for adult No longer necessary.
and pediatric candidates.

pCO2

This question will be optional for adult No longer necessary.
and pediatric candidates.

FeV1(L)/FVC(L)

This question will be optional for adult No longer necessary.
and pediatric candidates.

O2 requirement at
rest

This question will be optional for adult No longer necessary.
and pediatric candidates.

IV treated
pulmonary sepsis
episode >= 2 in last
12 months

This question will be optional for adult No longer necessary.
and pediatric candidates.

Page 14 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

Heart/Lung
Medical Factors

FIELD

MODIFICATION/ADDITION

RATIONALE

Corticosteroid
dependency >=
5mg/day

This question will be optional for adult No longer necessary.
and pediatric candidates.

Six minute walk
distance

This question will be optional for adult No longer necessary.
and pediatric candidates.

Infection requiring
IV drug therapy
within 2/wks prior
to listing

This question will be optional for adult No longer necessary.
and pediatric candidates.

History of cigarette
use – pack years

This question will be optional for adult No longer necessary.
and pediatric candidates.

Other tobacco use

This question will be optional for adult No longer necessary.
and pediatric candidates.

Page 15 of 16
4/2/2007

2007 Transplant Candidate Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Prior cardiac surgery
(nontransplant)
check all that apply
Prior lung surgery
(nontransplant)
check all that apply

For pediatric candidates replace
• CABG
• Valve Replacement/Repair
• Congenital
• Left Ventricular Remodeling
• Other, specify
• Pneumoreduction
• Pneumothorax Surgery-Nodule
• Pneumothorax Decortication
• Lobectomy
• Pneumonectomy
• Left Thoracotomy
• Right Thoracotomy
• Other, specify
With Prior thoracic surgery other than
previous transplant:
• If yes, number of prior
sternotomies
• If yes, number of prior
thoracotomies
AND Add
Prior congenital cardiac surgery:
Yes/No/Unknown
• If yes, palliative surgery:
Yes/No/Unknown
If yes, corrective surgery:
Yes/No/Unknown

Prior lung surgery
(nontransplant)
check all that apply

This question will be optional for adult No longer necessary.
candidates.

Page 16 of 16
4/2/2007

Additional data necessary to develop transplant policies
and to determine member specific performance.


File Typeapplication/pdf
File TitleFORM
Authorpugham
File Modified2007-04-02
File Created2007-04-02

© 2024 OMB.report | Privacy Policy