https://orcid.org/0000-0003-3523-0028
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Ethical Approval
The purpose of this project was to a) implement a practice to improve the quality of patient care, and b) collect patient data regarding the implementation of clinical practice. Under the HHS regulations, these activities do not satisfy the definition of “research” under 45 CFR 46.102 (d). For this reason, no additional study-specific informed consent or institutional review board approval was required for this quality improvement project. This project was reviewed and determined to be quality improvement using standardized criteria from the Office of Human Research Protection. This process takes into account the project’s intent, design, funding, patient risk above standard of care, and protection of health information.
Acknowledgments
Medical writing and editing support was provided by Adam Perahia, MD, of NorthStar Strategic Consulting, LLC, via funding by Fresenius Medical Care.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
LHF, JW, CM, MSA, and JLH are employees of Fresenius Medical Care, Global Medical Office. CJ Is an employee of Spectra Laboratories. CM, MSA, and CJ, own stock in Fresenius Medical Care North America. MSA is the Chief Medical Officer of Fresenius Renal Therapies Group. JLH is the Global Head of Clinical Affairs for Fresenius Medical Care.