Summry of Changes

05.19.2020 Summary of Changes - OPTN 0915-0184.docx

Organ Procurement and Transplantation Network Application Form

Summry of Changes

OMB: 0915-0184

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High Level Summary of Revisions to

OPTN Membership Application forms (0915-0184)

HRSA is submitting this summary of revisions to forms in the OPTN Membership Application ICR package (0915-0184) rather than submitting individual redlines of forms. The revisions are proposed to make OPTN membership application requirements more clear and organized, and thus less cumbersome for applicants to complete. Proposed revisions include changes to wording to make questions more consistent with the language of the OPTN Bylaws (Bylaws). The Bylaws outline membership requirements for organizations and individuals to participate the in U.S. transplant network.  In addition, the applications have been revised so that the sequence of questions is parallel to that of the Bylaws so that an applicant can have the application and Bylaws side-by-side for easy reference.

In addition, the 2020 OPTN Membership Application revisions will coincide with the introduction of a web based tool that will assist users to fill out the application forms and submit them electronically. Approval signatures required for application submission will also be captured electronically using a web based application tool.

Given these changes, the overall burden has decreased significantly from an estimated 7,020 total burden hours in 2017 to 4,755 hours in this current proposed revision package, although some forms have been combined into one more comprehensive form resulting in increased burden hours for a particular form.

Other changes include the following:

  • The “Membership – Surgeon or Physician transplant log,” previously included in other forms, is now a separate form that will be attached to each application. This new separate form will provide applicants with all requirements for a log per OPTN Bylaws for each organ and pathway.

  • Also within the applications, what were formerly known as “checkboxes”—fillable tables that were not really checkboxes at all—were removed and real checkboxes were put in to reduce the burden to applicants. The “narrative” section was replaced by checkbox “attestations,” which will serve the same purpose: understanding relevant and recent surgeon and physician applicant experience. The previous membership applications had several places for the applicants to sign; the new application requests only one signature from each individual member applicant involved.

  • Previous application attachments for key personnel and living donor components have been streamlined into one form for each respective organ application.

  • Pediatric Bylaw Requirements—where applicable—were also given their own sections in the organ applications.

  • The Certificate of Assessment (formerly known as Certificate of Investigation) and the Primary Coverage Plan Checklist were pulled out of the previous organ specific applications and given their own, separate form.

  • VCA Transplant program applications, which were previously submitted as separate applications based on the type of VCA body part transplanted, is now one single application with sections for each VCA organ type.

  • Personnel changes for Organ Procurement Organizations (OPOs) and Histocompatibility Laboratories have also been combined with organization applications, so that OPO and lab applicants will be able to use one respective application for new and personnel changes.

The table below provides more detail regarding the difference in the 2017 ICR package and the current 2020 package, and demonstrates which forms have been combined. Again, the overall purpose of these modifications is to make OPTN application requirements more clear and organized, more user-friendly, and less burdensome.



Current Cycle File HRSA SWIFT File Names: Expiring 7/31/2020

New HRSA File Names

60 Days FRN Supporting Statement

Names and Draft 30 Days FRN

Notes

A1_NewTransplantHospital_Cover

Membership_Transplant Hospital_General

OPTN Membership Application for Transplant Hospitals

 

A2_NewTransplant_General

B1_NewTransplantProgram_Cover_Clean_HRSA

N/A

N/A

No longer needed. Information is captured in new Kidney, Liver, Pancreas, Pancreas Islet, Heart, Lung and Intestine

B3_Kidney_LDKidney

Membership_Kidney_LDKidney

OPTN Membership Application for Kidney Transplant Programs

 

B4_Liver_LDLiver

Membership_Liver_LDLiver

OPTN Membership Application for Liver Transplant Programs

 

B5_Pancreas

Membership_Pancreas

OPTN Membership Application for Pancreas Transplant Programs

 

B6_Heart

Membership_Heart

OPTN Membership Application for Heart Transplant Programs

 

B7_Lung

Membership_Lung

OPTN Membership Application for Lung Transplant Programs

 

B8_PancreasIslet

Membership_PancreasIslet

OPTN Membership Application for Islet Transplant Programs

 

B9_NewLiving Donor Recoveries

N/A

N/A

No longer needed. Information is captured in new Kidney and Liver Applications

C_OPO_New

Membership_OPO

OPTN Membership Application for Organ Procurement Organizations (OPOs)

New Form will serve as new program and key personnel change request

G_OPO_DirectorChange

D_HistoLab_New

Membership_HistoLab

OPTN Membership Application for Histocompatibility Laboratories

New Form will serve as new program and key personnel change request

F_HistoLab_PersonnelChange

E_PersonnelChange_Cover

N/A

N/A

No longer needed: Members will use relevant portions of their respective organ applications to apply for a key personnel change

H_MedicalScientific

Membership_MedicalScientific

OPTN Medical/Scientific Membership Application

 

I_PublicOrg

Membership_PublicOrg

OPTN Public Organization Membership Application

 

J_Business

Membership_Business

OPTN Business Membership Application

 

K_Individual

Membership_Individual

OPTN Individual Membership Application

 

L_Intestine

Membership_Intestine

OPTN Membership Application for Intestine Transplant Programs

 

M1_VCA_NewTransplantProgram

 


 

M2_VCA_AW_Intestine

 


 

M3_VCA_AW_Kidney

 


 

M4_VCA_AW_Liver

 


 

M5_VCA_AW_Pancreas

 


 

M6_VCA_Head and Neck

Membership_VCA

OPTN Membership Application for Vascularized Composite Allograft (VCA) Transplant Programs

All requests for VCA have been combined into one form

M7_VCA_Upper Limb

 


 

N1_VCA_Other_NewTransplantProgram

 


 

N2_VCA_Other_PersonnelChange_Cover

 


 

N3_VCA_Other

 


 

O_VCA_PersonnelChange_Cover

 


 

 

Membership_SurgeonOrPhysicianLog

OPTN Membership Application Surgeon or Physician Log

New Independent Form. Information was previously collected within organ application. This form will accompany every application and must be filled out as part of membership application

 

Membership_CertificateAssessment_ProgramCoveragePlan

OPTN Certificate of Assessment and Program Coverage Plan Membership Application

New Independent Form. Information was previously collected within organ application. This form will accompany every application and must be filled out as part of membership application

 

Membership_Representative

OPTN Representative Form

New Form. Information is routinely collected from member

Total Forms = 30

Total Forms = 18


 



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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleSummary of Changes to OPTN Membership Applications
AuthorRoger Vacovsky
File Modified0000-00-00
File Created2021-01-13

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