Liver Registration Changes

2007 Transplant Recipient Registration Changes for OMB Clearance

ORGAN
All

SECTION
Patient Status

FIELD

MODIFICATION/ADDITION

RATIONALE

Was patient
This question will be optional for adult No longer necessary.
hospitalized during and pediatric recipients.
the last 90 days prior
to the transplant
admission?
Physical Capacity

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 18
4/2/2007

2007 Transplant Recipient Registration 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.
Work status if
working for income

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

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

Page 2 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION
Clinical
Information
Pretransplant

FIELD

MODIFICATION/ADDITION

RATIONALE

New

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

Additional data necessary to develop transplant policies.

Viral detection:
Have any of the
following viruses
ever been tested for

This question will be removed.

No longer necessary.

HIV

Replace with: HIV serostatus with
choices Positive, Negative, Not Done,
Unk/Cannot Disclose.

Detail no longer necessary.

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

Deleted.

Detail no longer necessary.

CMV

Deleted.

Detail no longer necessary.

CMV – Was there
Deleted.
clinical disease,
Nucleic acid testing,
Culture

Detail no longer necessary.

HBV

Deleted.

Detail no longer necessary.

HBV – Was there
clinical disease,
Liver histology,
DNA

Deleted.

Detail no longer necessary.

HCV

Replace with: HCV serostatus with
choices Positive, Negative, Not Done,
Unk/Cannot Disclose.

Detail no longer necessary.

Page 3 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

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

Deleted.

Detail no longer necessary.

EBV

Replace with: EBV serostatus with
choices Positive, Negative, Not Done,
Unk/Cannot Disclose.

Detail no longer necessary.

EBV – Was there
Deleted.
clinical disease, IgG,
IgM, DNA

Detail no longer necessary.

Clinical
Information
Post-Transplant

Was biopsy done to
confirm acute
rejection

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

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
Kidney

Patient Status

Academic activity
level

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

Page 4 of 18
4/2/2007

Additional data necessary to develop transplant policies.

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION
Clinical
Information
Pretransplant

Clinical
Information
Transplant
Procedure

FIELD

MODIFICATION/ADDITION

RATIONALE

Was preimplantation This question will be optional for adult No longer necessary.
kidney biopsy
and pediatric recipients.
performed at the
transplant center
Any tolerance
induction technique
used

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

Previous
pregnancies

This question will be optional for
pediatric recipients.

No longer necessary.

New

For pediatric recipients add
Is growth hormone therapy used
between listing and transplant:
Yes/No/Unknown

Additional data necessary to develop transplant policies.

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

Additional data necessary to develop transplant policies.

Total warm
This question will be optional for adult No longer necessary.
ischemia time right and pediatric recipients.
or en-bloc kidney
(include anastomotic
time)
Page 5 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Total warm
ischemia time left
kidney (include
anastomotic time)

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

Final flow rate at
transplant

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

Incidental tumor
This question will be optional for adult No longer necessary.
found at time of
and pediatric recipients.
transplant and tumor
type
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.

Clinical
Contributory causes This question will be optional for adult No longer necessary.
Information Post of graft failure:
and pediatric recipients.
Transplant
• Acute rejection
• Graft
thrombosis
• Infection
• Surgical
complications
• Urological
complications
• Recurrent
disease
• Other, specify
Kidney produced > This question will be optional for adult No longer necessary.
40ml of urine in first and pediatric recipients.
24 hours
Page 6 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD
Creatinine decline
by 25% or more in
first 24 hours on 2
separate samples

Pancreas

Clinical
Information
Transplant
Procedure

Clinical
Pancreas graft
Information Post removed
Transplant

Clinical
Information
Pretransplant

RATIONALE

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

If simultaneous
This question will be optional for adult No longer necessary.
transplant with
and pediatric recipients.
another organ, was
the pancreas
revascularized
before or after other
organs
Surgical incision

Kidney/Pancreas Patient Status

MODIFICATION/ADDITION

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

Date pancreas graft
removed

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

Academic activity
level

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

Pancreas secondary
source of payment

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

Additional data necessary to develop transplant policies.

Was preimplantation This question will be optional for adult No longer necessary.
kidney biopsy
and pediatric recipients.
performed at the
transplant center

Page 7 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

Clinical
Information
Transplant
Procedure

FIELD

MODIFICATION/ADDITION

RATIONALE

Any tolerance
induction technique
used

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

Previous
pregnancies

This question will be optional for
pediatric recipients.

No longer necessary.

New

For pediatric recipients add
Is growth hormone therapy used
between listing and transplant:
Yes/No/Unknown

Additional data necessary to develop transplant policies.

New

For pediatric recipients 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.

Was the pancreas
This question will be optional for adult No longer necessary.
revascularized
and pediatric recipients.
before or after other
organs
Surgical incision

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

Page 8 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Total warm
This question will be optional for adult No longer necessary.
ischemia time right and pediatric recipients.
or en-bloc kidney
(include anastomotic
time)
Total warm
ischemia time left
kidney (include
anastomotic time)

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

Final flow rate at
transplant

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

Incidental tumor
This question will be optional for adult No longer necessary.
found at time of
and pediatric recipients.
transplant and tumor
type
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 9 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Clinical
Kidney contributory This question will be optional for adult No longer necessary.
Information Post causes of graft
and pediatric recipients.
Transplant
failure:
• Acute rejection
• Graft
thrombosis
• Kidney
Infection
• Surgical
complications
• Urological
complications
• Recurrent
disease
• Other, specify
Kidney produced > This question will be optional for adult No longer necessary.
40ml of urine in first and pediatric recipients.
24 hours
Creatinine decline
by 25% or more in
first 24 hours on 2
separate samples

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

Pancreas graft
removed

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

Date pancreas graft
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.

Page 10 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN
Liver

SECTION
Clinical
Information
Pretransplant

Clinical
Information
Transplant
Procedure

FIELD

MODIFICATION/ADDITION

RATIONALE

Any tolerance
induction technique
used

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

Pretransplant lab
date

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

SGPT/ALT

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

Any previous
malignancy type

For pediatric recipients add options to
the pick list for Hepatoblastoma and
Hepatocellular Carcinoma.

Surgical procedure

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

Page 11 of 18
4/2/2007

Additional data necessary to develop transplant policies.

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

Split type Current
choices:
Split Types
• Left in situ
• Left on the
bench
• Lateral segment
in situ
• Lateral segment
on the bench
• Right in situ
• Right on the
bench
• Right triseg in
situ
• Right triseg on
the bench

Modify to
• Left lobe in situ (segments 2,3,4)
• Left lobe on the bench (segments
2,3,4)
• Left lobe with caudate in situ
(segments 1,2,3,4)
• Left lobe with caudate on the
bench (segments 1,2,3,4)
• Left lateral segment in situ
(segments 2,3)
• Left lateral segment on the bench
(segments 2,3)
• Right lobe without middle hepatic
vein in situ (segments 5,6,7,8)
• Right lobe without middle hepatic
vein on the bench (segments
5,6,7,8)
• Right lobe with middle hepatic
vein in situ (segments 4,5,6,7,8)
• Right lobe with middle hepatic
vein on the bench (segments
4,5,6,7,8)

Clarify information already presented.

Partial Types
• Right
• Right triseg
• Left
• Lateral segment

Modify to
Partial Types
• Right lobe without middle hepatic
vein (segments 5,6,7,8)
• Right lobe with middle hepatic
vein (segments 4,5,6,7,8)
• Left lobe (segments 2,3,4)
• Left lateral (segments 2,3)

Clarify information already presented.

Page 12 of 18
4/2/2007

RATIONALE

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Warm ischemia time This question will be optional for adult No longer necessary.
(include anastomotic and pediatric recipients.
time)
Did patient received This question will be optional for adult No longer necessary.
5 or more units of
and pediatric recipients.
packed red blood
cells within 48 hours
prior to
transplantation due
to spontaneous
portal hypertensive
bleed
Spontaneous
bacterial peritonitis

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

Incidental tumor
This question will be optional for adult No longer necessary.
found at time of
and pediatric recipients.
transplant and tumor
type
Clinical
Cause of graft
Information Post failure: Vascular
Transplant
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

Additional data necessary to develop transplant policies.

Discharge lab date

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

Total bilirubin

This question will be optional for adult No longer necessary.
and pediatric recipients.
Page 13 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

Intestine

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

SGPT/ALT

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

Serum albumin

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

Serum creatinine

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

INR

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

Clinical
Information
Pretransplant

Any previous
malignancy type

For pediatric recipients add options to
the pick list for Hepatoblastoma and
Hepatocellular Carcinoma.

Clinical
Information
Transplant
Procedure

Liver dysfunction

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

Additional data necessary to develop transplant policies.

Number previous
This question will be optional for adult No longer necessary.
abdominal surgeries and pediatric recipients.

Thoracic

Clinical
Primary Cause of
Information Post Graft Failure
Transplant

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.

Patient Status

Life Support

For pediatric recipients add an option
to the pick list for IV Inotropes when
organ type is heart/lung or lung.

Additional data necessary to develop transplant policies.

Clinical
Information
Pretransplant

New

For pediatric recipients calculate and
display cardiac index.

Additional data necessary to develop transplant policies.

Page 14 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

Oxygen requirement This question will be optional for adult No longer necessary.
at rest
and pediatric recipients.
Pulmonary
embolism

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

Cerebrovascular
event

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

Implantable
defibrillator

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

Page 15 of 18
4/2/2007

2007 Transplant Recipient 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 recipient 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

Previous
pregnancies

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

Page 16 of 18
4/2/2007

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

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD

Titer Information New

Clinical
Information
Transplant
Procedure

MODIFICATION/ADDITION

RATIONALE

For pediatric recipients 2 years old or
younger and status 1 at listing and
received a heart with incompatible
ABO 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.

Additional data necessary to develop transplant policies.

Was this a
This question will be optional for adult No longer necessary.
retransplant due to
and pediatric recipients.
failure of a previous
thoracic graft
Incidental tumor
This question will be optional for adult No longer necessary.
found at time of
and pediatric recipients.
transplant and tumor
type

Clinical
Primary cause of
Information Post graft failure
Transplant
New

Add an option to the pick list for Other, Allow for collection of reasons not listed.
specify
For pediatric recipients 2 years old or Additional data necessary to develop transplant policies.
younger and status 1 at listing and
received a heart with incompatible
ABO and death or graft failure is
reported 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.
Page 17 of 18
4/2/2007

2007 Transplant Recipient Registration Changes for OMB Clearance
ORGAN

SECTION

FIELD
Any drug treated
infection

MODIFICATION/ADDITION

RATIONALE

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

Cardiac re-operation This question will be optional for adult No longer necessary.
and pediatric recipients.
Other surgical
procedures

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

Time on inotropes
other than
Isoproterenol
(Isuprel)

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

Chest drain >2
weeks

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

Page 18 of 18
4/2/2007