Pediatric Heart and HeartLung Status 1B Initial Justification Form

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

Pediatric Heart and HeartLung Status 1B Justification Form

The Heart or Heart/Lung Status 1B Justification form displays for completion when upgrading a pediatric candidate to status 1B, extending a candidate's status 1B listing or when a candidate's status has been downgraded from status 1A to 1B.

You must complete and submit all required data on this form in UNet in order to register a patient as status 1B, in accordance with the criteria specified in policy. You may apply for an exception for a patient who does not meet the status 1B criteria if the transplant program believes, using acceptable medical criteria, that a heart candidate has an urgency and potential for benefit comparable to that of other 1B patients.

Candidates who meet criteria will be automatically approved for the requested status.

To manage exceptions or extensions for your candidate please use the Pediatric Heart Exception – Extension Management Report.

If a pediatric candidate is temporarily unsuitable for transplant, then the candidate’s transplant program may assign the candidate inactive status and the candidate will not receive any heart offers.

See OPTN Policies for additional information. Use the search feature to locate specific policy information on Pediatric Candidate Status.

Note: Completed forms cannot be edited by a member. To report a data discrepancy, or for help resolving data discrepancies, please contact the UNet^SM Help Desk by calling (800) 978-4334, or e-mailing unethelpdesk@unos.org.

1B Justification Status

Form title: The title indicates the age group, organ group, and the type of form.

Case number: This is the group of forms associated with an initial 1B form. This includes any appeals,

Submitted date: The timestamp of when the form was submitted displays.

Resolved date: The timestamp of when the form was resolved (Approved or Denied) displays. For forms that are auto-approved because they meet criteria, the date Resolved is the same as the date Submitted.

Status: The status of the form displays. This will vary based on the form’s disposition.

Effective: 1B forms display the beginning date that a 1B form is effective. Since 1B forms don’t expire, there is no end date like there is for 1A forms.

1B Justification Information

Transplant Center: Verify that the transplant center is correct.

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

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

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

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

ABO: The patient's ABO displays.

1B Justification Diagnosis

Diagnosis: The candidate's diagnosis displays.

1B Justification Criteria

To qualify for status 1B, the patient must either meet at least one of the criteria below (select all that apply) or an exception request must be submitted to the NHRB for review. For more information, review the NHRB guidance document.

By criteria:

1. Requires infusion of one or more inotropic agents but does not qualify for pediatric status 1A

2. Is less than one year old at the time of the candidate’s initial registration and has a diagnosis of hypertrophic or restrictive cardiomyopathy

• Hypertrophic cardiomyopathy

• Restrictive cardiomyopathy

By exception:

For those candidates that do not meet the criteria above and for whom the transplant physician believes, using acceptable medical criteria, that the candidate has an urgency and potential for benefit comparable to that of the other status 1B candidates, an exception may be requested and the narrative below will be reviewed by the National Heart Review Board.

1B Justification narrative

Enter a clinical narrative which supports the eligibility of the candidate for an exceptional case. Maximum of 5000 characters.

1B Justification Authorization

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

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

Email decision to: Enter at least one and up to three email addresses to receive notification of the outcome of the vote. Including up to three email addresses may be important to account for time off or out-of-office. This is a required field.

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 paperwork@hrsa.gov.   

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