REDLINE Ventilated Patient Form Instructions - OPTN Process Data 0906-NEW 11202025

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Ventilated Patient Form Instructions
The purpose of the Ventilated Patient Form (VPF) is to collect demographic information and
OPO process data on patients who:
• have a documented Pronouncement of Death,
• were ever-ventilated patients during their terminal hospitalization, and
• with a documented Pronouncement of Death who were referred to the OPO by a
hospital or identified by the OPO while onsite at the hospital, or found by the OPO upon
death record review as required byat 42 CFR 486.348(b).
Definition
• Required data field: A field is required only if it actually appears in the cascade flow of
control per specific responses to previous questions. Furthermore, partial Ventilated
Patient Form data can be collected and saved without completion of required data
fields; however the form cannot be transmitted to HRSA and/or the OPTN until all
required fields are completed.

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Status: This field is read-only and displays Incomplete. It will only change to Complete once
the record is successfully validated.
Hospital and OPO Data
DonorNet Donor ID: Enter the unique Donor ID and click Search. If this is a valid Donor ID,
then many of the field values below can be copied from the Deceased Donor Registration
(DDR) record to the same field in the VPF. In the VPF they will become read-only. All such
"copied" fields are noted individually, below. If this is a patient record only (no DonorNet Donor
ID), all fields need to be completed - nothing is copied.Enter the unique Donor ID and click
Search. If this is a valid Donor ID, then the values for OPO Record ID, OPO, Patient Hospital
(“Donor Hospital”), Date and time of first hospital referral for terminal admission, Date of
Referral, Last Name, First Name, Middle Initial, Age, Age Unit, Weight, Weight Unit, Patient's
Home Zip Code, Ethnicity, Race, Birth Sex, Height, Height Units, Cause of Death, Mechanism
of Death, Circumstance of Death, Date and Time of Pronouncement of Death are copied from
the Deceased Donor Registration (DDR) record to the VPF and will become read-only. If this is
a patient record only (no DonorNet Donor ID), all fields need to be completed.
OPO Record ID: If this is a patient with a Donor ID, the OPO Record ID from the donor record
displays and is read-only. If this is a patient record only, enter the OPO Record ID. This is a
required field.
OPO: If this is a patient with a Donor ID, the OPO from the donor record displays and is readonly. If this is a patient record only, select the OPO from the drop-down list. This is a required
field.
Patient Hospital: If this is a patient with a Donor ID, the Hospital from the donor record (“Donor
Hospital”) displays and is read-only. If this is a patient record only, select the Hospital from the
drop-down list. Verify the hospital name and the Medicare provider number of the hospital that
originally referred the patient or the hospital from which the patient was identified at death

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record review. A list of Medicare provider numbers for your state can be obtained in the Donor
Hospitals section of DonorNet. This is a required field.
Case Detail/How did the OPO learn of this patient?: Select as appropriate to indicate how
the OPO learned of this patient. This is a required field.
Hospital notification: A hospital referred the patient to the OPO.
Death record review: The OPO located the patient record upon review.
Hospital notification initially displays. If applicable, change the selection to Death record
review.

Demographic and Clinical Data

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Demographic and Clinical Data
Last Name: If this is a patient with a Donor ID, the Last Name from the donor record displays
and is read-only. If this is a patient record only, enter the patient’s Last Name. This is a
required field.

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First Name: If this is a patient with a Donor ID, the First Name from the donor record displays
and is read-only. If this is a patient record only, enter the patient’s First Name. This is a
required field.
Middle Initial: If this is a patient with a Donor ID, the Middle Initial from the donor record
displays and is read-only. If this is a patient record only, enter the patient’s Middle Initial. This
field is not required.
Note: If the donor identity is unknown, enter the hospital-generated alias.
Home Zip Code: If this is a patient with a Donor ID, the Home Zip Code from the donor record
displays and is read-only. Enter the U.S. Postal Zip Code of the location where the patient lived
before hospitalization. If Zip Code is unknown, select Unknown. Do not use the referring
hospital zip code as a proxy when Zip Code is unknown.. This is a required field.
Ethnicity: If this is a patient with a Donor ID, the Ethnicity from the donor record displays and is
read-only. If this is a patient record only, select as appropriate to indicate the Ethnicity of the
patient. The Revisions to the Standards for the Classification of Federal Data on Race and
Ethnicity (Office of Management and Budget (OMB) Statistical Policy Directive No. 15) define
the minimum standards for collecting and presenting data on race and ethnicity for all Federal
reporting. The OPTN collection of ethnicity is aligned to this standard.
OMB defines ethnicity to be whether or not a person self-identifies as Hispanic or Latino. For
this reason, ethnicity is broken out into two categories, (1) Hispanic or Latino or (2) Not Hispanic
or Latino. Select one ethnicity category or select 'Ethnicity Not Reported' if a category was not
self-identified by the person.

Commented [SG1]: We’re removing these sentences
until we update the race and ethnicity questions in
alignment with the new OMB standards.

This is a required field.
Hispanic or Latino – A person of Cuban, Mexican, Puerto Rican, South or Central
American, or other Spanish culture or origin, regardless of race.
Not Hispanic or Latino
Ethnicity Not Reported – Select if person did not self-identify an ethnicity category.
Race: If this is a patient with a Donor ID, the Race from the donor record displays and is readonly. If this is a patient record only, select as appropriate to indicate the Race of the patient. The
Revisions to the Standards for the Classification of Federal Data on Race and Ethnicity (Office
of Management and Budget (OMB) Statistical Policy Directive No. 15) define the minimum
standards for collecting and presenting data on race and ethnicity for all Federal reporting. The
OPTN collection of race is aligned to this standard. OMB defines race as a person’s selfidentification with one or more social groups.
An individual can select one or more race categories (1) White, (2) Black or African American,
(3) Asian, (4) American Indian or Alaska Native, (5) Native Hawaiian or Other Pacific Islander,
or Race Not Reported.

Commented [SG2]: We’re removing these sentences
until we update all race/ethnicity for alignment with the
updated OMB standards.

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This is a required field.
Select one or more race sub-categories or origins. Select 'Other Origin' if origin is not listed.
Select 'Origin Not Reported' if the origin was not self-identified by the person.
White – A person having origins in any of the original peoples of Europe, the Middle East, or
North Africa.
European Descent
Arab or Middle Eastern
North African (non-Black)
Other Origin
Origin Not Reported
Black or African American – A person having origins in any of the Black racial groups of
Africa.
African American
African (Continental)
West Indian
Haitian
Other Origin
Origin Not Reported
American Indian or Alaska Native – A person having origins in any of the original peoples of
North and South America (including Central America) and who maintains tribal affiliation or
community attachment.
American Indian
Eskimo
Aleutian
Alaska Indian
Other Origin
Origin Not Reported
Asian – A person having origins in any of the original peoples of the Far East, Southeast Asia,
or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea,
Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
Asian Indian/Indian Sub-Continent
Chinese
Filipino
Japanese
Korean
Vietnamese
Other Origin
Origin Not Reported

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Native Hawaiian or Other Pacific Islander – A person having origins in any of the original
peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
Native Hawaiian
Guamanian or Chamorro
Samoan
Other Origin
Origin Not Reported
Race Not Reported – Select if person did not self-identify a race category or origin.
Birth Sex: If this is a patient with a Donor ID, “Gender” from the donor record displays and is
read-only. If this is a patient record only, select as appropriate to indicate the Birth Sex of the
patient. Report donor sex (Male or Female), based on biologic and physiologic traits at birth. If
sex at birth is unknown, report sex at time of referral as reported by patient or documented in
medical record. The intent of this data collection field is to capture physiologic characteristics
that may have an impact on recipient size matching or graft outcome. This is a required field.
Height: If this is a patient with a Donor ID, Height from the donor record displays and is readonly. If this is a patient record only, enter the height of the patient in ft (feet) and in (inches) or
cm (centimeters). If the patient’s height is unavailable, select the reason from the status (ST)
drop-down list (N/A, Not Done, Missing, Unknown). This is a required field.
Weight: If this is a patient with a Donor ID, Weight from the donor record displays and is readonly. If this is a patient record only, enter the first measured weight of the patient after hospital
admission in lbs (pounds) or kg (kilograms). This is a required field. If the patient’s weight is
unavailable, select the reason from the status (ST) drop-down list (N/A, Not Done, Missing,
Unknown).
Age: If this is a patient with a Donor ID, Age from the donor record displays and is read-only. If
this is a patient record only, enter the date the donor was born using the standard 8-digit
numeric format of MM/DD/YYYY or enter the donor’s patient’s age in Years or Months. This is
a required field.
Cause of Death: If this is a patient with a Donor ID, Cause of Death from the donor record
displays and is read-only. If this is a patient record only, select the patient’s cause of death from
the drop-down list. This is a required field.
If the cause of death is not listed, select Other Specify, and enter the cause of death in the
Specify field. This is a required field.
Anoxia
Cerebrovascular/Stroke
Head Trauma
CNS Tumor
Other Specify
Mechanism of Death: If this is a patient with a Donor ID, Mechanism of Death from the donor
record displays and is read-only. If this is a patient record only, select the patient’s mechanism
of death from the drop-down list. If the mechanism of death is not listed, select None of the
Above. This is a required field.
Drowning

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Seizure
Drug Intoxication
Asphyxiation
Cardiovascular
Electrical
Gunshot Wound
Stab
Blunt Injury
SIDS
Intracranial Hemorrhage/Stroke
Death from Natural Causes
None of the Above
Circumstances of Death: If this is a patient with a Donor ID, Circumstance of Death from the
donor record displays and is read-only. If this is a patient record only, select the patient’s
circumstances of death from the drop-down list. If the circumstance of death is not listed, select
None of the Above. This is a required field.
MVA
Suicide
Homicide
Child-Abuse
Accident, Non-MVA
Death from Natural Causes
None of the Above
Did patient legally document decision to be an organ donor?: If this is a patient with a
Donor ID, “Did patient legally document decision to be a donor?” from the donor record displays
and is read-only. If this is a patient record only, if the patient record had legal documentation of
intent to be a donor, select Yes. If not, select No. If unknown, select Unknown. This is a
required field.
If the selection is No or Unknown, cascades to Date and Time of Pronouncement of
Death.
If the selection is Yes, cascades to First Person Authorization Restrictions.
First Person Authorization Restrictions: For each patient record with legal
documentation of intent to be a donor, select any restrictions. OPOs should reference
any document the OPO would consider applicable under their state laws. This is a
required field.
Kidney
Pancreas
Intestine
Liver
Heart
Lung
Tissue ((select if there are restrictions on any tissue, including ocular)any)
None
Date and Time of Pronouncement of Death: If this is a patient with a Donor ID, “Date and
Time of Pronouncement of Death” from the donor record displays and is read-only. If this is a

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patient record only, enter the date, using the standard 8-digit numeric format of MM/DD/YYYY,
and military time of pronouncement of death of the donor. This is a required field.
KDPI: For each patient record, provide the last calculation for the Kidney Donor Profile Index
(KDPI) if calculatedavailable. This field is not required.

OPO Process Data
Date of Death Record Review: For each patient record, enter the date of death record review,
using the standard 8-digit numeric format of MM/DD/YYYY. This is a required field.
Case Detail/How did the OPO learn of this patient?: Select as appropriate to indicate how
the OPO learned of this patient. This is a required field.
Hospital notificationreferral: A hospital referred the patient to the OPO or the OPO
identified the patient while onsite at the hospital. This value initially displays.
Death record review: The OPO located the patient record upon review. Change to this
value if applicable.
If the selection is Hospital referral, cascades to Date and Time of first hospital
referral for terminal admission..
Date and time of Ffirst Hhospital Rreferral for tTerminal Aadmission: If this
is a patient with a Donor ID, Referral Date from the donor record displays and is
read-only. If this is a patient-record only, Ffor each patient record referred by the
hospital to the OPO, enter the date, using the standard 8-digit numeric format of
MM/DD/YYYY, and military time of referral. This is a required field. After this
field, cascade to Did the OPO respond onsite at the hospital to the patient
referral?
Time of First Hospital Referral for Terminal Admission: For each patient
record referred by the hospital to the OPO, enter the military time of referral. This
is a required field. After this field, cascade to Did the OPO respond onsite at
the hospital to the patient referral?
Else if the selection is Death record review, cascades to Date of death record review.
Date and time of first hospital referral for terminal admission: For each
patient record referred by the hospital to the OPO, enter the date, using the
standard 8-digit numeric format of MM/DD/YYYY, and military time of referral.
This is a required field.

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Date of death record review Death record review: The OPO located the patient
record upon review.
Date of death record review: For each patient record, enter the date of death
record review, using the standard 8-digit numeric format of MM/DD/YYYY. This is
a required field. After this field, cascade to Case Disposition (Terminal Step).
Hospital notification initially displays. If applicable, change the selection to Death record

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review.
If the selection is hospital referral, cascades to Date and Time of first hospital referral for
terminal admission. Was the patient referred by the hospital to the OPO?: For each patient
record, indicate whether the patient was referred by the hospital to the OPO by selecting Yes or
No. This is a required field.

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If the selection is NodDeath record review, after the date is entered, cascades to Case
Disposition (Terminal Step).

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If the selection is Yeshospital referral, cascades to Date and Time of Hospital Referral.
Date and Time of Hospital Referral: For each patient record referred by the hospital to
the OPO, enter the date, using the standard 8-digit numeric format of MM/DD/YYYY,
and military time of referral. This is a required field.
Did the OPO respond onsite at the hospital to the patient referral?: For each patient record,
indicate whether the OPO responded onsite at the hospital to the patient referral by selecting
Yes or No. This is a required field.
If the selection is No, cascades to Remote EMR Access.
If the selection is Yes, cascades to Date and Time of first OPO Onsite Response
following referral.
Date and Time of first OPO Onsite Response following referral: For each patient
record, enter the date, using standard 8-digit numeric format of MM/DD/YYYY, and the
military time of OPO onsite response. This is a required field.
Remote EMR Access: For each patient record, For each referred patient, indicate whether the
OPO had patient-specific electronic access to the referred patient’s hospitahospital l remote
Electronic Medical Record (EMR) , access for the hospital by selecting Yes or No. This is a
required field.
Advance Directive: For each patient record, indicate whether the OPO located documentation
of an advance directive by selecting Yes, No, or Unknown. This is a required field.
Patient Donation Pathway(s)Patient Record Type: For each patient record, select the
category or categories of organ procurement for which the OPO followed the patient at any point
prior to case close. This is a required field.
Donation after Circulatory Death (DCD)
Donation after Brain Death (DBD)
Both DCD and DBD
Neither
Note: If the patient was medically ruled out before being followed for procurement,
select “Neither.”

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Was the patient medically ruled out by the OPO prior to approach?: For each patient
record, indicate whether the OPO determined- based on its internal medical rule-out criteriathat the patient was not suitable for medically ruled out the patient for the purposes of organ
procurement by selecting Yes or No. This is a required field.
If the selection is No, cascades to Method of Authorization Used by OPO.
If the selection is Yes, cascades to Case Disposition (Terminal Step).
Method of Authorization Used by OPO: If this is a patient with a Donor ID, the selection from
“Method of authorization used” from the donor record displays and is read-only. If this is a
patient record only, select whether the OPO identified First Person Authorization or
Hierarchy authorization for the purposes of procurement. This is a required field.
If the selection is First Person Authorization, cascades to Was there a family Legal
Next of Kin (LNOK) objection to organ procurement with first person
authorization?
If the selection is Hierarchy, cascades to Was there an approach for authorization
for organ procurement?
Was there a family Legal Next of Kin (LNOK) objection to organ procurement with
first person authorization?: For each patient record, select Yes or No if there was a
family LNOK objection to first person authorization. This is a required field. Note: Please
select yes if there was an objection, even if the objection was later resolved.
Was there an approach for authorization for organ procurement? For each patient
record, select Yes or No if there was an approach for authorization for organ
procurement. This is a required field.
If the selection is Yes, cascades to Date and Time of First OPO Hierarchy Approach
for Authorization.
If the selection is No, cascades to Case Disposition (Terminal Step).
Date and Time of First OPO Hierarchy Approach for Authorization: For each patient
record, enter the date, using standard 8-digit numeric format of MM/DD/YYYY, and the
military time of OPO onsite responseof first approach for authorization. This is a
required field.
Modality of Approach: For each patient record, select modality of first OPO hierarchy
approach for authorization from the drop-down list. This is a required field.
In-person
Phone
Video
Text (SMS)
Unknown

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Language of Approach: For each patient record with an approach, select language(s)
of first OPO hierarchy approach for authorization from the drop-down list. This is a
required field.
English
Spanish
Language other than English or Spanish
Translation Interpreter Used in Approach: For each patient record with an approach,
select whether OPO utilized interpretation or translation from any of the options on the
drop-down list. This is a required field.

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OPO staff
Patient family
Hospital
Third party service
Medical Translation Application
Other
None
Authorization: For each patient record with an approach, select the outcome from the
drop-down list. This is a required field.

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LNOK Authorized
LNOK Decline
Hospital Authorized
Hospital Declined
If the selection is LNOK Authorized or Hospital Authorized, cascades to Date and
Time of Authorization for Procurement.
If the selection is LNOK Decline or Hospital DeclinedNo, cascades to Case
Disposition (Terminal Step).

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Date and Time of Authorization for Procurement: For each patient record, enter the
date, using standard 8-digit numeric format of MM/DD/YYYY, and the military time of
authorization of procurement. This is a required field.
Tissue Authorization: For each patient record, indicate whether any tissue
procurement was authorized by selecting Yes, or No, or Non-applicable from the dropdown list. This is a required field.

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Terminal Step
Case Disposition: For each patient record, select the case disposition from the dropdown
menu. Select all that apply. This is a required field.

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Recovered Organ Donor
OPO Decline to Pursue Donation
First Person Authorization (FPA) Objection
Medical Rule Out
Procurement Denied by Medical Examiner/Coroner/Warden
Allocation Exhausted Prior to OR
Cardiac Arrest Prior to OR
Outside Expiration Time for DCD Recovery
Case Closed in OR Without Organs Recovered
Hospital Interference: For each patient record, select Yes or No if there is Hospital
Interference. This is a required field.

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If the selection is YesIf the selection is Hospital Interference, cascades to Describe
Hospital Interference.

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If the selection is No,For all other selections, cascades to Date and Time Case Close.
Describe Hospital Interference: For each patient record, indicate if which
hospital actions the OPO characterized hospital actions as interference. This is a
required field. Note: This field is intended to identify process improvement
opportunities.

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Ventilated Patient Not Referred to the OPO
Referral Made to OPO Outside of Timely Requirement
Unplanned Extubation After Referral Made to OPO
Hospital Blocked OPO Approach for Authorization
Reportable Interference:Report Provided to Hospital: For each patient record where
the OPO identifies hospital interference (according to its internal policies), select indicate
whether the OPO determined if the interference was a reportable to the hospital, regardless of
whether a donation ultimately occurred. Select a report to the hospital using Yes or No from
the drop-down list. This is a required field. Note: OPOs should retain reporting and remediation
documentation as follow-up may be required for quality improvement as per § 486.328.
Report to Hospital Accepted: For each patient record where the OPO identifies

hospital interference, select whether the hospital accepted the OPO report of
interference using Yes or No from the drop-down list. This is a required field.

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Remediation Plan Provided to Hospital: For each patient record where the OPO
identifies hospital interference, select whether a remediation plan was provided
by OPO to the hospital using Yes or No from the drop-down list. This is a
required field.

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Remediation Plan Accepted: For each patient record where the OPO identifies

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hospital interference, select whether the hospital accepted the OPO remediation
plan using Yes or No from the drop-down list. This is a required field.
Date and Time Case Close: For each patient record, enter the date, using standard 8-digit
numeric format of MM/DD/YYYY, and the military time of OPO case close. This is a required
field. This action completes the form. Note: Case close represents the point at which the OPO
has completed all active management and evaluation activities for the case and no further
clinical or authorization actions are expected, even if follow-up reporting or hospital quality
documentation occurs later. Later error corrections will not change date and time of case close.
Public Burden Statement: The private, non-profit Organ Procurement and Transplantation Network
(OPTN) collects this information in order to perform the following OPTN functions: to assess whether
applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of
member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it displays a currently valid OMB control
number. The OMB control number for this information collection is 0906-XXXX and it is valid until
XX/XX/202X. This information collection is required to obtain or retain a benefit per 42 CFR
§121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records
#09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the
Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as
prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems,
and the Departments Automated Information Systems Security Program Handbook. The public reporting
burden for this collection of information is estimated to average 0.3750 hours per response, including
the time for reviewing instructions, searching existing data sources, and completing and reviewing the
collection of information. Send comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this burden, to HRSA Information Collection
Clearance Officer, 5600 Fishers Lane, Room 14NWH04, Rockville, Maryland, 20857 or
[email protected].