Pediatric Liver Status 1B Initial Justification and Extension Form

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

Pediatric Liver Status 1B Form

To assign a candidate status 1B, the candidate’s transplant hospital must submit a Liver Status 1B Justification Form to the OPTN. A candidate is not registered as status 1B until this form is submitted.

Status 1B listing automatically reverts to MELD/PELD score ranking after 7 days unless re-listed by an attending physician. To avoid automatic reversion, you must complete the Liver Status 1B Extension form. If an extension form is not completed by midnight on the seventh day, then the candidate is assigned to the most recent MELD/PELD score. If no previous MELD/PELD score exists, the candidate is assigned a score of 6.

Pediatric Liver Status

Status: Verify the candidate's listing of Status 1A is correct.

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.

Liver Status 1B Listing Date: Verify the candidate's liver Status 1B listing date is correct.

Initial Listing/Extension Form Effective Date: Verify the candidate's initial listing/extension form effective date is correct.

Patient Name: Verify that the candidate's name is correct.

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

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

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

Transplant Center: Verify that the transplant center is correct.

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

Height: Enter the candidate's height in feet and inches or centimeters. The height must fall between 0 and 7 feet or 1 and 225 centimeters. This is a required field for pediatric candidates.

Date: Enter the date the candidate's height was measured.

Weight: Enter the weight of the candidate at the time of listing in the appropriate space, in pounds or kilograms. The weight must fall between 0 and 650 pounds or 0 and 295 kilograms. This is a required field for pediatric candidates.

Date: Enter the date the candidate was weighed.

Status 1B Criteria

Select one of the following criteria:

Chronic liver disease: If the candidate has chronic liver disease, complete the following fields:

Select all that apply:

Gastrointestinal bleeding requiring red blood cell replacement

Indicate amount: Enter the amount of red blood cell replacement in mL/kg. The entry must fall between 0 and 100. This is a required field if gastrointestinal bleeding requiring red blood cell replacement is selected.

Date: Enter the date the red blood cell replacement was given using the format MM/DD/YYYY. This is a required field if gastrointestinal bleeding requiring red blood cell replacement is selected.

On mechanical ventilator

Requires dialysis

Requires continuous veno-venous hemofiltration (CVVH)

Requires continuous veno-venous hemodialysis (CVVHD)

Non-Metastic Hepatoblastoma suitable for liver transplantation: If the candidate has a non-metastic hepatoblastoma and is suitable for a liver transplant, complete the following fields.

Biopsy: If a biopsy was performed, select Yes. If not, select No. This is a required field if Non-Metastatic Hepatoblastoma is selected.

Date: Enter the date the biopsy was performed using the format MM/DD/YYYY. This is a required field if Biopsy is Yes.

Metabolic disease: If the candidate has a metabolic disease, select all that apply.

Urea cycle defects: If Urea cycle defects is selected, indicate the type of defect.

OTC: If the candidate has Ornithine Transcarbamylase (OTC) Deficiency, select OTC.

Other - Specify: If the defect is not OTC or there is a defect in addition to OTC, then enter the type of defect.

Organic Acidemias: If Organic Acidemias is selected, indicate the type of acidemias.

Please specify type: Enter the type of Organic Acidemias. This is a required field if Organic Acidemias is selected.

Diagnosis: Enter the candidate's diagnosis. This is a required field.

MELD/PELD Data Collection

Serum Creatinine: Enter the serum creatinine value. The value must fall between 0.10 to 20.00 mg/dl. This field is required for candidates who are 10 and older. If a serum creatinine value is entered, then enter the Test Date using the format MM/DD/YYYY. Also, if a serum creatinine value is entered, then select Yes or No for Had dialysis twice within a week prior to the test.

Had dialysis twice, or 24 hours of CVVHD, within a week prior to the serum creatinine test?: If candidate had dialysis twice, or 24 hours of CVVHD, within a week prior to the serum creatinine test, select Yes. If not, select No. If the candidate did not have serum creatinine test, select N/A. If the candidate is 10 or older, select Yes or No.

Serum Sodium: Enter the serum sodium value. The value must fall between 100.00 and 200.00 mg/dl. Next, enter the Test Date using the format MM/DD/YYYY.

Child-Turcotte Pugh (CTP) Scoring System to Assess Severity of Liver Disease

Encephalopathy: Enter the date of the encephalopathy test. Next, indicate whether the value was None, 1–2, or 3–4. The severity is judged according to the candidate's symptoms. The most commonly used staging scale of hepatic encephalopathy is called the West Haven Grading System. The date is required for all values, except for N/A. Value cannot be N/A for adult candidates. This field is only required when adding or removing candidates 12 years and older. This does not affect the MELD/PELD score but is used for calculating CTP score.

Note: If lab values (excluding Encephalopathy and Ascites) are updated and the Encephalopathy and/or Ascites dates are not within 48 hours of the other values, then the data for Encephalopathy and/or Ascites will be removed. This is to eliminate the confusion of having a mix of updated and old lab values for MELD/PELD and CTP data.

Ascites: Enter the date of the ascites test. Next indicate whether the value was Absent, Slight (or controlled by diuretics) or At least moderate despite diuretic treatment. The date is required for all values, except for N/A. Value cannot be N/A for adult candidates. This field is only required when adding or removing candidates 12 years and older. This does not affect the MELD/PELD score but is used for calculating CTP score.

Note: If lab values (excluding Encephalopathy and Ascites) are updated and the Encephalopathy and/or Ascites dates are not within 48 hours of the other values, then the data for Encephalopathy and/or Ascites will be removed. This is to eliminate the confusion of having a mix of updated and old lab values for MELD/PELD and CTP data.

Bilirubin (mg/dL): Enter the bilirubin value in the space provided. The entry must fall between 0 and 99 mg/dl. This is a required field.

Albumin (g/dL): Enter the albumin value in the space provided. The value must fall between 0.50–9.90 g/dL. This field is required for candidates aged 12 and older when adding, changing the status of, or removing a candidate from the Waitlist.  

INR: Enter the International Normalized Ratio (INR) value in the space provided. The value must fall between 0.50–99. 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 [email protected].   

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