Kidney/Pancreas Follow-up Changes

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN
All

SECTION
Patient Status

FIELD
Number of
hospitalizations

MODIFICATION/ADDITION

RATIONALE

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

Was there evidence This question will be optional for adult No longer necessary.
of noncompliance
and pediatric recipients.
with
immunosuppression
medication during
this follow-up
period that
compromised the
patient’s recovery

Page 1 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

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 2 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

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

Physical Capacity

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

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

Clinical
Information

Work status if
working for income

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

New

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

Page 3 of 13
4/2/2007

Additional data necessary to develop transplant policies.

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Height

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

Was biopsy done to
confirm acute
rejection

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

Were any of the
This question will be removed for adult No longer necessary.
following viruses
and pediatric recipients.
tested for onset or
recurrence during
this follow-up
period: (HIV, CMV,
HBV, HCV, EBV,
BK)
HIV

This question will be removed for adult No longer necessary.
and pediatric recipients.

HIV – Was there
clinical disease
(ARC, AIDS),
Antibody, RNA

This question will be removed for adult No longer necessary.
and pediatric recipients.

CMV

This question will be removed for adult No longer necessary.
and pediatric recipients.

CMV – Was there
This question will be removed for adult No longer necessary.
clinical disease,
and pediatric recipients.
Nucleic acid testing,
Culture
HBV

This question will be removed for adult No longer necessary.
and pediatric recipients.

Page 4 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

HBV – Was there
clinical disease,
Liver histology,
Core Antibody,
Surface antigen,
DNA

This question will be removed for adult No longer necessary.
and pediatric recipients.

HCV

This question will be removed for adult No longer necessary.
and pediatric recipients.

HCV – Was there
clinical disease,
Liver histology,
Antibody, RIBA,
RNA

This question will be removed for adult No longer necessary.
and pediatric recipients.

EBV

This question will be removed for adult No longer necessary.
and pediatric recipients.

EBV – Was there
This question will be removed for adult No longer necessary.
clinical disease, IgG, and pediatric recipients.
DNA, IgM
Treatment

Biological or antiviral therapy

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

Other therapies

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

Did the patient
This question will be optional for adult No longer necessary.
participate in any
and pediatric recipients.
clinical research
protocol for
immunosuppressive
medications

Page 5 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN
Kidney

SECTION
Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Weight

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

New

For pediatric recipients add
Additional data necessary to develop transplant policies.
Is growth hormone therapy used during
this follow-up period:
Yes/No/Unknown

Urine protein found
by any method

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

Diabetes during the
follow-up period

Modify question to Diabetes onset
during the follow-up period.

Dialysis provider
number

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

Dialysis provider
name

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

Page 6 of 13
4/2/2007

Clarify information already presented.

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Contributory causes This question will be optional for adult No longer necessary.
of graft failure
and pediatric recipients.
• Acute rejection
• Chronic
rejection
• Graft
thrombosis
• Infection
• Urological
complications
• Patient
noncompliance
• Recurrent
disease
• BK (Polyoma)
Virus
• Other, specify
BK

This question will be removed for adult No longer necessary.
and pediatric recipients.

BK: Was there
This question will be removed for adult No longer necessary.
clinical disease,
and pediatric recipients.
Kidney histology,
DNA (PCR) testing,
Urine cytology

Page 7 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Pancreas

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

New

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

Treatment

Treatment for BK
(polyoma) virus

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

Clinical
Information

Pancreas graft
removed

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

Date pancreas
removed

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

Serum Amylase

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

CMV: IgG, IgM

This question will be removed for adult No longer necessary.
and pediatric recipients.

New

For pediatric recipients add
Additional data necessary to develop transplant policies.
Is growth hormone therapy used during
this follow-up period:
Yes/No/Unknown

Urine protein found
by any method

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

Dialysis provider
number

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

Kidney/Pancreas Clinical
Information

Page 8 of 13
4/2/2007

Additional data necessary to develop transplant policies.

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD
Dialysis provider
name

MODIFICATION/ADDITION

RATIONALE

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

Contributory causes This question will be optional for adult No longer necessary.
of graft failure
and pediatric recipients.
• Acute rejection
• Chronic
rejection
• Graft
thrombosis
• Infection
• Urological
complications
• Patient
noncompliance
• Recurrent
disease
• BK (Polyoma)
Virus
• Other, specify
Pancreas graft
removed

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

Date pancreas
removed

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

Was biopsy done to
confirm pancreas
rejection

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

Serum Amylase

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

Page 9 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD
BK

MODIFICATION/ADDITION

RATIONALE

This question will be removed for adult No longer necessary.
and pediatric recipients.

BK: Was there
This question will be removed for adult No longer necessary.
clinical disease,
and pediatric recipients.
Kidney histology,
DNA (PCR) testing,
Urine cytology

Liver

Clinical
Information

New

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

Treatment for BK
(polyoma) virus

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

Weight

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

Cause of graft
failure: Vascular
thrombosis

For pediatric recipients when vascular
thrombosis is Yes add:
• Hepatic arterial thrombosis:
Yes/No/Unknown
• Hepatic outflow obstruction:
Yes/No/Unknown
• Portal vein thrombosis:
Yes/No/Unknown
Page 10 of 13
4/2/2007

Additional data necessary to develop transplant policies.

Additional data necessary to develop transplant policies.

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Contributory causes This question will be optional for adult No longer necessary.
of graft failure:
and pediatric recipients.
Patient
noncompliance

Intestine

Clinical
Information

Diabetes during the
follow-up period

Modify question to Diabetes onset
during the follow-up period.

Clarify information already presented.

CMV: IgG, IgM

This question will be removed for adult No longer necessary.
and pediatric recipients.

Discharge lab date

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

Discharge total
bilirubin

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

Discharge
SGPT/ALT

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

Discharge serum
albumin

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

Discharge serum
creatinine

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

Discharge INR

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

Most recent
SGPT/ALT

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

Most recent serum
albumin

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

Most recent INR

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

Weight

This question will be optional for adult No longer necessary.
recipients.
Page 11 of 13
4/2/2007

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

Thoracic

SECTION

Clinical
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

Primary Cause of
Graft Failure

For pediatric recipients add options to
the pick list for GVHD (Graft Versus
Host Disease) and Ischemia/NEC
(Necrotizing Enterocolitis Like
Syndrome.

Additional data necessary to develop transplant policies.

Diabetes during the
follow-up period

Modify question to Diabetes onset
during the follow-up period.

Clarify information already presented.

CMV: IgG, IgM

This question will be removed for adult No longer necessary.
and pediatric recipients.

Total bilirubin

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

Serum albumin

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

Weight

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

Primary cause of
graft failure

Add an option to the pick list for Other, Allow for collection of reasons not listed.
specify

New

For pediatric recipients 2 years old or
younger and status 1 at listing and
received a heart with incompatible
ABO and death or graft failure is
reported and 1 year follow-up add:
Current B titer and sample date when
ABO is A, Current A titer and sample
date when ABO is B and Current titer
A, sample date, Current titer B and
sample date when ABO is O.

CAD: Clinically
significant events

This question will be optional for adult No longer necessary.
and pediatric recipients.
Page 12 of 13
4/2/2007

Additional data necessary to develop transplant policies.

2007 Transplant Recipient Follow-up Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

CMV: IgG, IgM

This question will be removed for adult No longer necessary.
and pediatric recipients.

Drug treated
hypertension

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

Bone disease
(Symptomatic)

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

Chronic liver
disease

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

Cataracts

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

Diabetes during the
follow-up period

Modify question to Diabetes onset
during the follow-up period.

Stroke

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

Drug treated
hyperlipidemia

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

Page 13 of 13
4/2/2007

Clarify information already presented.