November 1, 2021
Ms. Lisa Wright-Solomon
HRSA Information Collection Clearance Officer
Health Resources and Services Administration (HRSA)
5600 Fishers Lane Room 14N136B
Rockville, MD 20857
Submitted Electronically: [email protected]
RE: Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157 – Revision
Dear Ms. Wright-Solomon:
Thank you for the opportunity to provide input to the Health Resources and Services Administration (HRSA)’s Information Collection Request (ICR) entitled “Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157 – Revision” on behalf of the Association of Organ Procurement Organizations (AOPO).
AOPO is the national representative of 48 federally designated, non-profit Organ Procurement Organizations (OPOs) in the United States, who together serve millions of Americans. AOPO is dedicated to providing education, information sharing, research, and technical assistance, and collaboration with OPOs, other stakeholders, and federal agencies to continue this nation’s world-leading transplant rates while consistently improving towards the singular goal of saving as many lives as possible.
Specifically, HRSA has requested comment on 4 issues: 1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, 2) the accuracy of the estimated burden, 3) ways to enhance the quality, utility, and clarity of the information to be collected, and 4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
1. The necessity and utility of the proposed information collection for the proper performance of the agency’s functions
The data forms noted in the ICR that are most pertinent to OPOs include: Deceased Donor Registration, Donor Histocompatibility, Organ Labeling and Packaging, Organ Tracking and Validating, Disease Transmission Event, Safety Situation, Potential Disease Transmission and Request to Unlock. AOPO supports the requirements for data submission and agrees these forms remain necessary to support continued, high performance of the Organ Procurement and Transplantation Network (OPTN).
2. The accuracy of the estimated burden
The Centers for Medicaid & Medicare Services (CMS) has set a benchmark of 41,000 annual transplants by 2026. AOPO has set its own ambitious goal to reach 50,000 organ transplants annually during the same period. AOPO recommends that the methodology to determine annualized burden hours for all forms account for anticipated increased staff hours spent on enhanced data collection and performance improvement initiatives related to achieving these goals of increasing the total number of donors.
3. Ways to enhance the quality, utility, and clarity of the information to be collected
AOPO and individual OPOs appreciate having an opportunity to provide feedback on form changes proposed by the OPTN through the OPTN public comment period. Many AOPO members participate in the OPTN committees that proposed the changes to the forms listed in the ICR. AOPO fully supports these form changes which were approved by the OPTN Board of Directors prior to publishing the ICR. The changes provide for more consistent and accurate data collection by modifying, removing, or relocating certain data elements. These changes provide OPO staff with improved direction and clarity when entering deceased data into the forms which improves the overall quality and utility of the data being collected. AOPO recommends a continued emphasis on collecting data that pertains to race, ethnicity, social determinants of health, and any other characteristics that will help to achieve equity in organ donation and transplantation.
4. The use of automated collection techniques or other forms of information technology to minimize the information collection burden
The forms OPOs complete for the OPTN are submitted electronically through the UNet technology platform. OPOs are building systems that have the ability to transfer donor information from the OPO electronic donor record directly into UNet, automating and streamlining data collection processes. AOPO applauds ongoing efforts of the OPTN to support these efforts and avoid unnecessary data collection and duplication of data entry, as well as continuous quality control monitoring and feedback, which helps to ensure the secure transmission of accurate data while minimizing burden on OPOs.
As the nation’s leading voice for OPOs, AOPO represents the thousands of dedicated OPO professionals working together with donor families, hospitals, and transplant programs, to ensure every donation opportunity results in a life saved. We appreciate this opportunity to provide feedback and welcome future opportunities to collaborate with HRSA, CMS and other stakeholders toward our shared goal of improving the health of those in need of life-saving transplants. If you have any questions about the content of this letter, please contact Mark Cribben, Director of Government Affairs, at [email protected].
Thank you,
Jan Finn
President, AOPO