Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data

OMB No. 0915-0157; Expiration Date: XX/XX/20XX

Adult Heart and HeartLung Status 1-6 Justification Form Demographic Data

Justification Form Demographic Data

Age Group: Age group of the candidate will display.

Status: The candidate's heart medical urgency status will display.

Surgeon/Physician NPI: Enter the NPI of the candidate's surgeon/physician. This is a required field.

Surgeon/Physician name: Enter the name of the candidate's surgeon/physician. This is a required field.

Heart status 1-6 initial listing date: Verify the candidate's status 1-6 initial listing date.

Form effective date: The date the form begins to drive the candidate's medical urgency displays.

Name: Verify that the patient's name is displayed correctly.

SSN: Verify that the patient's social security number is correct.

Waitlist ID: Verify that the patient's Waitlist ID number is correct.

Date of Birth: Verify that the patient's date of birth is correct.

Transplant center: Verify that the transplant center is correct.

Hospital telephone number: Enter the transplant's hospital telephone number. This is a required field.

Diagnosis: Verify the patient's diagnosis.

Age: The patient’s age displays.

Height: The patient’s height displays.

Weight: The patient’s weight displays.

Is the candidate currently admitted to the listing transplant hospital? If the candidate is currently admitted to the listing transplant hospital, select Yes. If not, select No. This is a required field.

Report the device that qualifies the candidate for the medical urgency status as the primary device. One additional support device can be reported as the secondary device. If the medical urgency status requires the candidate to be on a BiVAD, then the two VAD devices must be reported separately in the primary device and secondary device fields.

Primary device: Select the candidate’s primary device type from the drop-down list of options.

TAH
IABP
VA ECMO
Percutaneous Device
Dischargeable VAD
Non-Dischargeable VAD

Device brand: If non-dischargeable VAD is selected, choose the brand of the device from the drop-down list of options. If you select Other, Specify enter the device brand in the Other specify field.

Abiomed BVS 5000
Biomedicus
Medos
Thoratec IVAD
Toyobo
Abiomed AB5000
Berlin Heat EXCOR
CentriMag (Thoratec/Levitronix)
Maquet Josta Rotaflow
Terumo DuraHeart
Thoratec PVAD
Ventracor VentrAssist
PediMag (Thoratec/Levitronix)
Other Specify

Device brand: If dischargeable VAD is selected, choose the brand of the device from the drop-down list of options. If you select Other, Specify enter the device brand in the Other specify field.

HeartMate II
Heartsaver VAD
Jarvik 2000
Evaheart
Heartware HVAD
Worldheart Levacor
HeartMate III
ReliantHeartAssist 5
ReliantHeart aVAD
Other Specify

Date of implant/initiation: Enter the date the device was implanted/date of initiation. Date of implant/date of initiation cannot exceed the current date. The date must be in the following format: MM/DD/YYYY. A calendar link is available.

Time of implant/initiation: Enter the time of implant/time of initiation. Device support begins when the procedure begins to insert or implant the device. The intent of this field is to validate time frame requirements in policy for qualifying criteria (evidence, events, or measurements) that must occur prior to implant or initiation of device support. The time must be in the following 24-hour format: HH:MM. Time must be in military format.

• Enter the earliest of the following: documented procedure start time, operation start time, surgery start time, or incision time.

• Defining support as the procedure start time provides the most consistent and largest acceptable time period for candidates.

• Suggested data sources include: anesthesia record, operative report, or circulation record/OR nurses record.

Note: Time of implant is a required field if the candidate is being listed at status 1, criteria 1

Ventricle support: If applicable, select the type of ventricle support from the list of options.

Left
Right
Single

Secondary device: Select the candidate’s secondary device type from the list of options.

IABP
VA ECMO
Percutaneous Device
Dischargeable VAD
Non-Dischargeable VAD

Date of implant/initiation: Enter the date the device was implanted. Date of implant/date of initiation cannot exceed the current date. The date must be in the following format: MM/DD/YYYY. A calendar link is available.

Ventricle support: If applicable, select the appropriate ventricle support from the list of options.

Left
Right

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 0915-0157 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 0.27 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 14N39, Rockville, Maryland, 20857 or [email protected].   

OPTN Restricted