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Letters to the Editor Finally, HMBANA is supportive of collaborative research. The organization’s research committee reviews all requests for collaboration, based on assessment of project feasibility, cost, and likely benefit to the medical and patient communities. Sincerely, Kimberly Updegrove, RN, CNM, MSN, MPH President, Human Milk Banking Association of North America Executive Director, Mothers’ Milk Bank at Austin Email: [email protected] Reference 1. Human Milk Banking Association of North America. Guidelines for the Establishment and Operation of a Donor Human Milk Bank, 2013 Edition. Fort Worth, TX: HMBANA; 2013.
DOI: 10.1177/0890334413519500
Authors’ Response to “A Letter to the Editor Regarding ‘Donor Human Milk Bank Data Collection in North America: An Assessment of Current Status and Future Needs’ from the Human Milk Banking Association of North America” We appreciate Ms Updegrove’s interest in our work and are grateful for the opportunity to respond to her concerns. Published data by the Human Milk Banking Association of North America (HMBANA) disclose only the yearly aggregate volume of distributed donor milk that is voluntarily reported to HMBANA by its milk banks. A true centralized registry would allow stakeholders, including client neonatal intensive care units (NICUs), to receive summary or benchmarking information from HMBANA. The NICU at Connecticut Children’s Medical Center has routinely used HMBANA donor human milk for over 3 years and is both a clinical and an academic stakeholder in the donor human milk banking industry. Our NICU has never received any such communication from HMBANA; neither are we aware of others who have. Ms Updegrove cites the constraints of HIPAA regulations and lack of access to records at client NICUs as hampering HMBANA’s participation in a centralized registry as recommended by the FDA. We propose that collaborating with institutions with accredited human research protection oversight would assist HMBANA to overcome these barriers, allowing a HIPAA-compliant response to the FDA by combining HMBANA milk bank data with aggregate, deidentified NICU
data. As we suggested, an FDA-responsive registry could be modeled after the Vermont-Oxford Network, which has collected, summarized, and distributed data on management and outcomes of very low birth weight (VLBW) infants for over 25 years and yielded many improvements in VLBW care worldwide. The Vermont-Oxford Network model demonstrates that developing a centralized, multisite data registry is feasible without compromising patient or site privacy or violating federal law. Regarding commitment to quality improvement, our comments were specific to registry development in the context of the FDA recommendations. We acknowledged that HMBANA conducts internal peer-reviewed bank assessments in the article’s introduction. We stand by our conclusions. Our study demonstrates that data are not presently standardized at participating HMBANA sites with respect to data collected, definitions, or platform. We agree that this research did not directly measure why NICUs may or may not have formal donor milk programs. However, given the need for precise standards in neonatal intensive care, we believe it is eminently reasonable to suggest that more consistent definitions, especially regarding preterm versus term milk, will facilitate benchmarking, quality improvement, and research, and encourage the establishment of NICU donor milk programs. Regarding transparency, our study findings suggest it is likely that clinicians at client NICUs are fortifying donor milk with inadequate knowledge of its macronutrient composition. To improve fortification practices, NICUs with formal donor human milk programs may wish to clarify bank-specific definitions of preterm/term milk when ordering from HMBANAaffiliated sites. This could be especially important for NICUs ordering donor milk from multiple HMBANA milk banks. We agree with Ms Updegrove that development of a robust centralized data repository would be useful to health care providers, families, and researchers. Such a registry, resulting from partnership between academic centers, HMBANA, its affiliated milk banks, and their client NICUs, will be an important step toward the shared goal of ultimately decreasing morbidity and mortality in sick premature infants. Sincerely, Elizabeth A. Brownell, PhD, MA Mary M. Lussier, RN, IBCLC James I. Hagadorn, MD, MS Victor C. Herson, MD Kathleen A. Marinelli, MD, IBCLC, FABM, FAAP Connecticut Human Milk Research Center Hartford, CT, USA Email: [email protected] research-article2014
DOI: 10.1177/0890334413520076
Downloaded from jhl.sagepub.com at NORTH CAROLINA STATE UNIV on May 12, 2015
Letters to the Editor Finally, HMBANA is supportive of collaborative research. The organization’s research committee reviews all requests for collaboration, based on assessment of project feasibility, cost, and likely benefit to the medical and patient communities. Sincerely, Kimberly Updegrove, RN, CNM, MSN, MPH President, Human Milk Banking Association of North America Executive Director, Mothers’ Milk Bank at Austin Email: [email protected] Reference 1. Human Milk Banking Association of North America. Guidelines for the Establishment and Operation of a Donor Human Milk Bank, 2013 Edition. Fort Worth, TX: HMBANA; 2013.
DOI: 10.1177/0890334413519500
Authors’ Response to “A Letter to the Editor Regarding ‘Donor Human Milk Bank Data Collection in North America: An Assessment of Current Status and Future Needs’ from the Human Milk Banking Association of North America” We appreciate Ms Updegrove’s interest in our work and are grateful for the opportunity to respond to her concerns. Published data by the Human Milk Banking Association of North America (HMBANA) disclose only the yearly aggregate volume of distributed donor milk that is voluntarily reported to HMBANA by its milk banks. A true centralized registry would allow stakeholders, including client neonatal intensive care units (NICUs), to receive summary or benchmarking information from HMBANA. The NICU at Connecticut Children’s Medical Center has routinely used HMBANA donor human milk for over 3 years and is both a clinical and an academic stakeholder in the donor human milk banking industry. Our NICU has never received any such communication from HMBANA; neither are we aware of others who have. Ms Updegrove cites the constraints of HIPAA regulations and lack of access to records at client NICUs as hampering HMBANA’s participation in a centralized registry as recommended by the FDA. We propose that collaborating with institutions with accredited human research protection oversight would assist HMBANA to overcome these barriers, allowing a HIPAA-compliant response to the FDA by combining HMBANA milk bank data with aggregate, deidentified NICU
data. As we suggested, an FDA-responsive registry could be modeled after the Vermont-Oxford Network, which has collected, summarized, and distributed data on management and outcomes of very low birth weight (VLBW) infants for over 25 years and yielded many improvements in VLBW care worldwide. The Vermont-Oxford Network model demonstrates that developing a centralized, multisite data registry is feasible without compromising patient or site privacy or violating federal law. Regarding commitment to quality improvement, our comments were specific to registry development in the context of the FDA recommendations. We acknowledged that HMBANA conducts internal peer-reviewed bank assessments in the article’s introduction. We stand by our conclusions. Our study demonstrates that data are not presently standardized at participating HMBANA sites with respect to data collected, definitions, or platform. We agree that this research did not directly measure why NICUs may or may not have formal donor milk programs. However, given the need for precise standards in neonatal intensive care, we believe it is eminently reasonable to suggest that more consistent definitions, especially regarding preterm versus term milk, will facilitate benchmarking, quality improvement, and research, and encourage the establishment of NICU donor milk programs. Regarding transparency, our study findings suggest it is likely that clinicians at client NICUs are fortifying donor milk with inadequate knowledge of its macronutrient composition. To improve fortification practices, NICUs with formal donor human milk programs may wish to clarify bank-specific definitions of preterm/term milk when ordering from HMBANAaffiliated sites. This could be especially important for NICUs ordering donor milk from multiple HMBANA milk banks. We agree with Ms Updegrove that development of a robust centralized data repository would be useful to health care providers, families, and researchers. Such a registry, resulting from partnership between academic centers, HMBANA, its affiliated milk banks, and their client NICUs, will be an important step toward the shared goal of ultimately decreasing morbidity and mortality in sick premature infants. Sincerely, Elizabeth A. Brownell, PhD, MA Mary M. Lussier, RN, IBCLC James I. Hagadorn, MD, MS Victor C. Herson, MD Kathleen A. Marinelli, MD, IBCLC, FABM, FAAP Connecticut Human Milk Research Center Hartford, CT, USA Email: [email protected] research-article2014
DOI: 10.1177/0890334413520076
Downloaded from jhl.sagepub.com at NORTH CAROLINA STATE UNIV on May 12, 2015
