Imminent-Eligible Death Changes

Imminent-Eligible Death Doc.pdf

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

Imminent-Eligible Death Changes

OMB: 0915-0157

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2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

The following data fields will provide
the information necessary to determine
if a death notification will provide an
eligible donor or an imminent
neurological death.
Provider
Information

Status
Determination

New

OPO provider information. This data
will be populated from previously
entered data.

Contract requirement.

New

Donor hospital information. This data
will be populated from previously
entered data.

Contract requirement.

New

Has consent been obtained? This data
will be populated from previously
entered data.

Contract requirement.

New

Requested by. This is an internal field
to document the person who requested
the action.

Contract requirement.

New

Time zone. This data will be populated Contract requirement.
from previously entered data.

New

Is daylight savings time observed?
This data will be populated from
previously entered data.

Contract requirement.

New

Eligibility status. This is a calculated
field based on other data entered.
Choices are Unknown, Eligible or
Ineligible.

Contract requirement.

Page 1 of 11
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2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

FIELD
New

MODIFICATION/ADDITION

RATIONALE

Imminent neurological death. This is a Contract requirement.
calculated field based on other data
entered. Choices are Unknown, Yes or
No.
The following data fields will
determine eligibility and imminent
neurological death.

New

Ventilator support.

Contract requirement.

New

Severe neurological injury

Contract requirement.

New

GCS known

Contract requirement.

New

If yes, Score

Contract requirement.

New

Absence of brain stem reflexes

Contract requirement.

New

If Yes, Which reflexes are absent
• Corneal reflex
• Doll’s eyes reflex
• Papillary reaction
• Response to painful stimuli
• Cough reflex
• Gag reflex
• Response to iced caloric
• Spontaneous breathing

Contract requirement.

New

Deteriorated to cardiac death

Contract requirement.

New

Legally declared brain dead

Contract requirement.

New

Exclusions, the following data fields
will provide exclusionary criteria for
all death notifications.

Contract requirement.

Page 2 of 11
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2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

New

Agranulocytosis – general

Contract requirement.

New

Aplastic anemia – general

Contract requirement.

New

Aspergillus (active) – fungal

Contract requirement.

New

Candidemia (active) or yeast infection
(invasive) – fungal

Contract requirement.

New

Coccidioides (active) fungal

Contract requirement.

New

CMV (active) viral

Contract requirement.

New

Creutzfeldt-Jacob Disease – prion

Contract requirement.

New

Cryptococcus (active) – fungal

Contract requirement.

New

Current malignant neoplasms – general Contract requirement.

New

EBNA – viral

Contract requirement.

New

EBV VCA IgG – viral

Contract requirement.

New

EBV VCA IgM – viral

Contract requirement.

New

Encephalitis (active) – bacterial

Contract requirement.

New

Encephalitis (active) – fungal

Contract requirement.

New

Encephalitis (active) – parasitic

Contract requirement.

New

Encephalitis (active) – viral

Contract requirement.

New

Gangrenous bowel – bacterial

Contract requirement.

New

HBsAg (reactive) – viral

Contract requirement.

New

Herpes simplex (active) – viral

Contract requirement.

New

Histoplasma (active) – fungal

Contract requirement.

New

History of melanoma – general

Contract requirement.

New

Hodgkins’ disease – general

Contract requirement.

Page 3 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

FIELD

MODIFICATION/ADDITION

RATIONALE

New

HIV – viral

Contract requirement.

New

HTLV I/II – viral

Contract requirement.

New

Immaturity (extreme) – general

Contract requirement.

New

Intra-abdominal sepsis – bacterial

Contract requirement.

New

Leishmania (active) – parasitic

Contract requirement.

New

Leprosy – bacterial

Contract requirement.

New

Leukemia – general

Contract requirement.

New

Lymphoma – general

Contract requirement.

New

Malaria/Plasmodium (active) –
parasitic

Contract requirement.

New

Meningitis (active) – bacterial

Contract requirement.

New

Meningitis (active) – fungal

Contract requirement.

New

Meningitis (active) – parasitic

Contract requirement.

New

Meningitis (active) – viral

Contract requirement.

New

Myeloma (multiple) - general

Contract requirement.

New

Multi-system organ failure – general

Contract requirement.

New

Perforated bowel – bacterial

Contract requirement.

New

Pneumonia (active) – viral

Contract requirement.

New

Previous malignant neoplasms with
current evident metastatic disease –
general

Contract requirement.

New

Rabies – viral

Contract requirement.

New

Retroviral infections – viral

Contract requirement.

New

SARS – viral

Contract requirement.
Page 4 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

Provider
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

New

Strongyloides (active) – parasitic

Contract requirement.

New

Trypanosome cruzi (active) – parasitic

Contract requirement.

New

Tuberculosis – bacterial

Contract requirement.

New

Varicella zoster (active) – viral

Contract requirement.

New

West Nile Virus Infection – viral

Contract requirement.

If imminent neurological death is
determined the following data will be
collected. Version A.

Contract requirement.

New

OPO provider information. This data
will be populated from previously
entered data.

Contract requirement.

New

Donor hospital information. This data
will be populated from previously
entered data.

Contract requirement.

New

Date and time of pronouncement of
death

Contract requirement.

New

How did you learn of the case

Contract requirement.

New

Date of hospital notification

Contract requirement.

New

Has consent been obtained for organ
donation

Contract requirement.

New

Was consent requested

Contract requirement.

New

Reason consent not requested

Contract requirement.

New

Reason consent not obtained

Contract requirement.

New

Requested by

Contract requirement.
Page 5 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION
Demographics

FIELD

MODIFICATION/ADDITION

RATIONALE

New

Last name

Contract requirement.

New

First name

Contract requirement.

New

ABO

Contract requirement.

New

Date of birth

Contract requirement.

New

Age

Contract requirement.

New

Gender

Contract requirement.

New

Eligibility status. This is a calculated
field based on other data entered.
Choices are Unknown, Eligible or
Ineligible.

Contract requirement.

New

Imminent neurological death. This is a Contract requirement.
calculated field based on other data
entered. Choices are Unknown, Yes or
No.

New

Cause of death

Contract requirement.

New

Mechanism of death

Contract requirement.

New

Circumstances of death

Contract requirement.

New

Ethnicity/Race

Contract requirement.

Was intent to be a donor documented

Contract requirement.

If yes mechanisms that apply
• Driver’s license
• Donor card
• Donor registry
• Durable power of
attorney/healthcare proxy
• Other, specify

Contract requirement.

Procurement and New
Consent
New

Page 6 of 11
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2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

Provider
Information

FIELD

MODIFICATION/ADDITION

RATIONALE

New

Tests that confirmed neurological
death:
• Angiography
• EEG
• Flow study
• Other, specify

Contract requirement.

New

If an eligible consented donor is
determined where no organs are
recovered with the intent to transplant
the following data will be collected.
Version B.

Contract requirement.

New

OPO provider information. This data
will be populated from previously
entered data.

Contract requirement.

New

Donor hospital information. This data
will be populated from previously
entered data.

Contract requirement.

New

Date and time of pronouncement of
death

Contract requirement.

New

How did you learn of the case

Contract requirement.

New

Date of hospital notification

Contract requirement.

New

Has consent been obtained for organ
donation

Contract requirement.

New

Was consent requested

Contract requirement.

New

Reason consent not requested

Contract requirement.

New

Requested by

Contract requirement.
Page 7 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION
Demographics

FIELD

MODIFICATION/ADDITION

RATIONALE

New

Last name

Contract requirement.

New

First name

Contract requirement.

New

ABO

Contract requirement.

New

Date of birth

Contract requirement.

New

Age

Contract requirement.

New

Gender

Contract requirement.

New

Eligibility status. This is a calculated
field based on other data entered.
Choices are Unknown, Eligible or
Ineligible.

Contract requirement.

New

Imminent neurological death. This is a Contract requirement.
calculated field based on other data
entered. Choices are Unknown, Yes or
No.

New

Cause of death

Contract requirement.

New

Mechanism of death

Contract requirement.

New

Circumstances of death

Contract requirement.

New

Ethnicity/Race

Contract requirement.

Medical examiner/coroner accepted
case

Contract requirement.

New

Medical examiner/coroner’s decision

Contract requirement.

New

Was intent to be a donor documented

Contract requirement.

Procurement and New
Consent

Page 8 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

Clinical
Information

Lifestyle Factors

FIELD

MODIFICATION/ADDITION

RATIONALE

New

If yes, mechanisms that apply
• Driver’s license
• Donor card
• Donor registry
• Durable power of
attorney/healthcare proxy
• Other, specify

Contract requirement.

New

Consent based only on documentation

Contract requirement.

New

Did the patient express to family or
others the intent to be a donor

Contract requirement.

New

Date and time consent obtained for first Contract requirement.
organ

New

Serum creatinine

Contract requirement.

New

BUN

Contract requirement.

New

SGOT/AST

Contract requirement.

New

SGPT/ALT

Contract requirement.

New

History of hypertension

Contract requirement.

New

If yes, method of control
• Diet
• Diuretics
• Other hypertensive medication

Contract requirement.

If a non-consenting eligible death is
determined the following data will be
collected. Version C.

Page 9 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION
Provider
Information

Demographics

FIELD

MODIFICATION/ADDITION

RATIONALE

New

OPO provider information. This data
will be populated from previously
entered data.

Contract requirement.

New

Donor hospital information. This data
will be populated from previously
entered data.

Contract requirement.

New

Date and time of pronouncement of
death

Contract requirement.

New

How did you learn of the case

Contract requirement.

New

Date of hospital notification

Contract requirement.

New

Has consent been obtained for organ
donation

Contract requirement.

New

Was consent requested

Contract requirement.

New

Reason consent not requested

Contract requirement.

New

Requested by

Contract requirement.

New

Last name

Contract requirement.

New

First name

Contract requirement.

New

ABO

Contract requirement.

New

Date of birth

Contract requirement.

New

Age

Contract requirement.

New

Gender

Contract requirement.

New

Eligibility status. This is a calculated
field based on other data entered.
Choices are Unknown, Eligible or
Ineligible.

Contract requirement.

Page 10 of 11
4/4/2007

2007 Imminent and Eligible Death Changes for OMB Clearance
SECTION

FIELD

MODIFICATION/ADDITION
Imminent neurological death. This is a
calculated field based on other data
entered. Choices are Unknown, Yes or
No.
Cause of death
Mechanism of death
Circumstances of death
Ethnicity/Race

Procurement and
Consent

Medical examiner/coroner accepted
case
Medical examiner/coroner’s decision
Was intent to be a donor documented
If yes mechanisms that apply
• Driver’s license
• Donor card
• Donor registry
• Durable power of
attorney/healthcare proxy
• Other, specify
Consent based only on documentation

Page 11 of 11
4/4/2007

RATIONALE

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

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