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pdf2007 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
4/4/2007
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
4/4/2007
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
4/4/2007
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 Type | application/pdf |
File Title | FORM |
Author | pugham |
File Modified | 2007-04-04 |
File Created | 2007-04-04 |