Form 139 Adult Heart and HeartLung Status 3 Initial Justification

Adult Heart and HeartLung Status 3 Initial Justification Form Medical Urgency Data
Fields to be completed by members
Form Section	Field Label	Notes
Status 3 Justification Form Section IV	Dischargeable left ventricular assist device (LVAD) for discretionary 30 days
Status 3 Justification Form Section IV	Multiple inotropes or a single high dose inotrope and hemodynamic monitoring
Status 3 Justification Form Section IV	Select one of the following
Status 3 Justification Form Section IV	Candidate is supported by either
Status 3 Justification Form Section IV	A continuous infusion of at least one high dose intravenous inotrope
Status 3 Justification Form Section IV	Was the candidate on inotropic or mechanical support at the time cardiac index was obtained?
Status 3 Justification Form Section IV	Cardiac index
Status 3 Justification Form Section IV	Cardiac index - Test Date
Status 3 Justification Form Section IV	Cardiac index - Test Time
Status 3 Justification Form Section IV	Pulmonary capillary wedge pressure
Status 3 Justification Form Section IV	Pulmonary capillary wedge pressure - Test Date
Status 3 Justification Form Section IV	Pulmonary capillary wedge pressure - Test Time
Status 3 Justification Form Section IV	Systolic blood pressure
Status 3 Justification Form Section IV	Systolic blood pressure - Test Date
Status 3 Justification Form Section IV	Systolic blood pressure - Test Time
Status 3 Justification Form Section IV	Mechanical circulatory support device (MCSD) with hemolysis
Status 3 Justification Form Section IV	Two separate samples collected within 48 hours of each other confirming markers of active hemolysis as evidenced by at least two of the following
Status 3 Justification Form Section IV	Mechanical circulatory support device (MCSD) with pump thrombosis
Status 3 Justification Form Section IV	Mechanical circulatory support device (MCSD) with right heart failure
Status 3 Justification Form Section IV	Dobutamine
Status 3 Justification Form Section IV	Dobutamine - Date of Initiation
Status 3 Justification Form Section IV	Dopamine
Status 3 Justification Form Section IV	Dopamine - Date of Initiation
Status 3 Justification Form Section IV	Epinephrine
Status 3 Justification Form Section IV	Epinephrine - Date of Initiation
Status 3 Justification Form Section IV	Milrinone
Status 3 Justification Form Section IV	Milrinone - Date of Initiation
Status 3 Justification Form Section IV	Inhaled nitric oxide
Status 3 Justification Form Section IV	Inhaled nitric oxide - Date of Initiation
Status 3 Justification Form Section IV	Intravenous prostacyclin
Status 3 Justification Form Section IV	Intravenous prostacyclin - Date of Initiation
Status 3 Justification Form Section IV	Pulmonary capillary wedge pressure
Status 3 Justification Form Section IV	Pulmonary capillary wedge pressure - Test Date
Status 3 Justification Form Section IV	Pulmonary capillary wedge pressure - Test Time
Status 3 Justification Form Section IV	Central venous pressure
Status 3 Justification Form Section IV	Central venous pressure - Test Date
Status 3 Justification Form Section IV	Central venous pressure - Test Time
Status 3 Justification Form Section IV	Mechanical circulatory support device (MCSD) with device infection
Status 3 Justification Form Section IV	Mechanical circulatory support device (MCSD) with mucosal bleeding
Status 3 Justification Form Section IV	Number of hospitalizations for mucosal bleeding within the past six months
Status 3 Justification Form Section IV	Mechanical circulatory support device (MCSD) with aortic insufficiency (AI)
Status 3 Justification Form Section IV	Veno-arterial extracorporeal membrane oxygenation (VA ECMO) after 7 days
Status 3 Justification Form Section IV	Non-dischargeable, surgically implanted, non-endovascular left ventricular assist device (LVAD) after 14 days
Status 3 Justification Form Section IV	Percutaneous endovascular circulatory support device after 14 days
Status 3 Justification Form Section IV	Intra-aortic balloon pump after 14 days
Status 3 Justification Form Section IV	Mechanical Circulatory Support Device (MCSD) with life threatening ventricular arrhythmia after 7 days
Status 3 Justification Form Section IV	Select at least one of the following
Status 3 Justification Form Section IV	Exception for status 3
Status 3 Justification Form Section IV	This exception request is specifically related to a device recall
Status 3 Justification Form Section IV	Clinical Narrative
OMB No. 0915-0157; Expiration Date: XX/XX/20XX
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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].