Ensuring Infant Feeding Safety: A Quality Improvement Imperative for Neonatal Nurses

By: Suzanne Smith, MS, RD, LDN, IBCLC and Caroline Steele, MS, RD, IBCLC, FAND

In neonatal care, safe and accurate infant feeding is paramount. Despite advanced technology, feeding safety often receives insufficient attention until problems arise from specific practices. Unlike medication safety, the rigorous preparation, handling, and administration of human milk and formula are not always prioritized. Robust quality improvement (QI) initiatives, continuous monitoring, and outcome measurements are crucial to elevate feeding safety’s role in patient well-being.

The Critical Importance of Infant Nutrition and Safety

Neonatal nurses face the dual challenge of ensuring optimal infant nutrition while safeguarding against potential risks. The American Society for Parenteral and Enteral Nutrition (ASPEN) recently highlighted contaminant concerns in infant formulas, emphasizing nutrition’s critical role in infant health, growth, and cognitive development. 1 All foods, including human milk and formula, contain contaminants from natural processes or human activities. It’s nearly impossible to fully prevent exposure to these contaminants, making infants particularly susceptible to their health and cognitive impacts.1 This emphasizes the need for continuous formula testing and the establishment of safe limits, overseen by the U.S. Food and Drug Administration (FDA). 1 When human milk is unavailable or insufficient, infant formula is the recommended alternative; ASPEN strongly advises against homemade formulas, unformulated animal milks, or toddler formulas due to their inability to meet precise nutritional needs. 1

Ensuring safe formula preparation and use in the Neonatal Intensive Care Unit (NICU) is paramount, with ASPEN outlining several non-negotiable guidelines:1

  • Safe Water Source: Use bottled or ‘infant/nursery’ water.
  • Precision: Meticulously follow manufacturer’s instructions or facility recipes, ideally using a gram scale for powders and accurate graduated devices for liquids.
  • Aseptic Technique: Maintain impeccable hand hygiene and aseptic technique in a clean preparation space, away from the bedspace, sanitizing all feeding items.
  • Storage Guidelines: Adhere strictly to storage guidelines; use orally fed formula within two hours of preparation at room temperature or within the one hour of starting the oral feeding; enterally fed formula can hang for four hours at room temperature; facility prepared formula or opened ready-to-feed formulas should be refrigerated until use and discarded after 24 hours.
  • Recall Protocol: Implement a robust recall protocol to immediately stop using and remove recalled formula, identify exposed patients, and prevent further administration.

Integrating Quality Improvement into Infant Feeding Practices

For neonatal nurses, integrating QI initiatives into human milk and formula handling is an ethical imperative. Robust QI programs identify potential failure points, mitigate risks, and enhance patient safety.

Best Practices and Regulatory Frameworks

Ongoing assessment and monitoring of feeding preparation processes are essential to evaluate quality and identify issues proactively. A comprehensive QI program should ensure:

  • Human milk (HM) and formulas prepared on site are nutritionally appropriate.2-10
  • HM and formulas are prepared accurately and safely by trained personnel.2-10
  • Donor human milk (DHM), formulas, fortifiers, and modulars are not expired or recalled.7-8
  • Potential failure points are identified to reduce contamination risk during preparation, storage, delivery, and administration.4-13
  • Feedings are prepared and delivered to minimize misadministration.3-10, 13, 14

Leading professional organizations, including ASPEN,1,14 the National Association of Neonatal Nurses (NANN),15 the Academy of Breastfeeding Medicine (ABM),16 and the Human Milk Banking Association of North America (HMBANA),11 have published best practices for HM and formula handling in acute care, emphasizing dedicated preparation locations, trained staff, proper identification, checking lot numbers, and error prevention.

Regulatory bodies also play a significant role. The Joint Commission (TJC) suggests applying Hazard Analysis Critical Control Point (HACCP) guidelines to human milk and formula preparation. 17 TJC standards include assigning responsibility for safe food provision, requiring sanitary preparation, integrating infection control, and using at least two patient identifiers to prevent misidentification. 17-18 The Facility Guidelines Institute (FGI) recommends a separate feeding preparation room for aseptic conditions. 19 Furthermore, human milk handling questions in US News & World Report Best Hospitals rankings for neonatology services highlight its increasing recognition as a crucial patient safety metric.20

Risk Factor Analysis and Mitigation Strategies

Understanding potential risks is the first step toward effective mitigation. For human milk and formula preparation and administration, risks include:

  • Patient harm: From incorrect, expired, recalled, or contaminated feedings.
  • Regulatory citations: Including potential Health Insurance Portability and Accountability Act (HIPAA) breaches.
  • Financial impact: Encompassing fines, medical complication costs, lost revenue, and increased labor for error follow-up.
  • Loss of family satisfaction and confidence.
  • Liability.

Infection prevention and control is another major risk factor.5, 14, 21, 22 The goal is to prevent foodborne illness by limiting microorganism entry into sterile feeds and controlling microbial growth in nonsterile powdered formulas. Flowcharting the process from production to administration can help identify risks and improve performance.

Quality Indicators and Methodologies

TJC emphasizes that quality indicators should focus on problem-prone, high-risk, or high-volume areas.17 These include:

  • Structural indicators: Ensuring physical and human resources meet regulatory requirements and best practices (e.g., dedicated preparation room).
  • Process indicators: Monitoring adherence to policies and procedures (e.g., aseptic technique, accurate recipe calculation, staff training).
  • Outcome indicators: Evaluating end results (e.g., feeding tolerance, lack of feeding-related illness, misadministration incidents, formula waste).

Several data collection methods highlight quality indicators of concern:12, 23, 24

  • Failure Mode and Effects Analysis (FMEA): This proactive tool evaluates current processes to identify potential failure points. By assessing severity, occurrence, and detectability (e.g., through a Risk Priority Number, RPN), FMEA helps identify critical failure points and their root causes, informing targeted improvement efforts.23-25
  • Hazard Analysis Critical Control Point (HACCP) System: A seven-step, proactive, science-based approach to prevent microbial contamination.12, 26 Key steps include: (1) conducting a hazard analysis; (2) determining critical control points (CCPs) (e.g., purchasing, storage, preparation, delivery, administration); (3) establishing critical limits; (4) monitoring procedures; (5) establishing corrective action; (6) establishing verification procedures; and (7) establishing record-keeping and documentation procedures.12, 23, 27 A multidisciplinary team is crucial for success.
  • Plan-Do-Check-Act (PDCA) Cycle: A continuous improvement methodology used for identifying potential failure points, implementing change, and ongoing monitoring.24, 28
    • Plan: Evaluate current state, identify risks and needs, identify solutions, outline process, costs, and stakeholders.
    • Do: Identify responsible and impacted individuals, create an implementation plan, develop policies and procedures, conduct training, implement plan.
    • Check: Assess performance, conduct root-cause analysis if objectives not met, consider action.
    • Act: Determine if further changes are needed, decide whether to continue with current process or execute changes, implement changes as appropriate.

Quality Improvement Examples in Practice

Centralized Human Milk and Formula Handling

Healthcare facilities increasingly centralize HM and formula preparation to improve accuracy, efficiency, and reduce contamination risk.3, 7-9, 11 Metrics for evaluation include tracking errors/near misses, nursing satisfaction, time savings, and cost reductions from reduced waste.1-10, 13

Automated Calculations

Manual calculation errors in infant feeding recipes can lead to serious health consequences.4, 8-10 Automated calculation systems, integrated with provider orders, significantly reduce human error and improve efficiency. Research shows such systems can decrease daily time reviewing feeding orders by over 50% 4, 8 and minimize waste by calculating exact ingredient amounts.10

Bar Code Scanning: A Safety Net

Barcode scanning technology verifies each component of a patient’s enteral nutrition order.4-10, 13 While human milk scanning for correct patient identification is standard,18, 29-30 scanning all fortifiers, additives, and enteral formulas is less universally adopted, despite its critical importance. Barcode scanning offers several advantages over manual two-person verification: enhanced accuracy, efficiency, error prevention by alerting to incorrect/expired/recalled items, and tracking of lot numbers.4-10, 13, 31-35

Scanning human milk is particularly vital. As a bodily fluid, HM carries infection transmission risks.37 Misadministration can lead to accidental infection, drug exposure, allergic reactions, HIPAA breaches, and significant financial/reputational costs.7, 11, 17, 37 Barcode scanning ensures proper patient identification at multiple steps: prior to label printing, during preparation, before administration, and at discharge.5-8 Extending scanning to all enteral formulas and products is equally important, as incorrect items can cause metabolic disturbances or allergic reactions.8, 14, 30

Formula Recall Management

Recent widespread infant formula recalls, like the 2022 Cronobacter sakazakii incident,37-38 highlight the critical need for robust recall management. The FDA now requires hospitals to identify and track recalled items, execute instructions, and maintain records.37-38 This heightened oversight necessitates processes—manual or automated via barcode scanning—to track lot numbers throughout the infant feeding process, vital for patient safety and data provision during FDA site visits.8

Conclusion

Safe preparation, handling, and administration of human milk and formula are fundamental to quality neonatal nursing care. By embracing quality improvement, best practices, regulatory adherence, and technological advancements like automated calculations and barcode scanning, neonatal nurses can significantly enhance patient safety. Continuous monitoring and outcome measurements are vital to maintain standards and address potential issues promptly. This rigorous approach is not merely about compliance; it’s about protecting our most vulnerable patients and building trust in our care.

Achieving these critical safety standards, however, often requires innovative solutions and dedicated partnerships

Imagine a future of unparalleled accuracy and safeguarded feedings, supported by leading industry experts. This future is possible with Timeless Medical Systems®. Our Timeless Medical Nutrition Platform™ uses advanced barcode scanning to prevent recalled items from reaching patients to minimizing errors. Plus, our globally recognized clinical team offers consulting services to optimize your workflows and ensure non-negotiable protocols. We also provide comprehensive courses for human milk and formula technicians, equipping your staff with specialized knowledge.

This powerful combination of technology, expert guidance, and education empowers your team to be strong, reliable advocates for precious neonates. Ready to achieve the highest standard of infant feeding safety? Visit www.timelessmedical.com or email sales@timelessmedical.com to learn more.

For more information about the Timeless Medical Nutrition Source™ and Timeless Medical Nutrition Platform™, please visit our website at www.timelessmedical.com or email us at sales@timelessmedical.com.

References

  1. American Society for Parenteral and Enteral Nutrition (ASPEN). (2024). ASPEN Statement on Contaminants in Infant Formulas. Retrieved June 30, 2025. https://nutritioncare.org/wp-content/uploads/2025/04/ASPEN-Statement-on-Contaminants-in-Infant-Formula-2025_Clean.pdf
  2. Barbas KH. Mother’s milk technicians: a new standard of care. J Hum Lact. 2013;29:323–327. doi:10.1177/0890334413492910
  3. Smith, S. Guidelines for Safety and Quality Assurance When Preparing Infant Feedings. Newborn Infant Nurs. Rev. 2008;8(2):101-107. doi: 10.1053/j.nainr.2008.03.013
  4. Steele C, Czerwin A, Bixby C. Breast milk bar code scanning results in time savings and staff efficiency. J Acad Nutr Diet. 2015;115:23–26. doi: 10.1016/j.jand.2014.06.360
  5. Steele C. Best practices for handling and administration of expressed human milk and donor human milk for hospitalized preterm infants. Front Nutr. 2018;5(76):1-5.
  6. Steele C. Safe handling of human milk within the hospital setting. Neonatal Intensive Care J Perinatol Neonatol. 2020;33(3):11-14. ismp.org/ext/1371
  7. Steele C, Bixby C. Centralized breastmilk handling and bar code scanning improve safety and reduce breastmilk administration errors. Breastfeed Med. 2014;9(9):426-429. doi:10.1089/bfm.2014.0077
  8. Steele C, Bixby C. Barcode scanning of human milk and enteral formulas improves efficiency and patient safety: a 7-year review. Nutr Clin Pract. 2022;37(4):921-928. https://doi.org/10.1002/ncp.10765
  9. Perkey K. Delivering results: Opening an infant nutrition center. Future Dimens Clin Nutr Pratc. 2016. 8–12.
  10. Steele C, Alessi S. Evaluation of the Use of Dedicated Technicians and Bar Code Scanning Technology for Fortified Human Milk Feeding Preparation in a Single Neonatal Intensive Care Unit to Reduce Risk of Adverse Events. J Acad Nutr Diet. 2024;124(5):559-563.
  11. Mannel R, Taylor, S. Best Practices for Expressing, Storing, and Handling Human Milk in Hospitals, Homes and Child Care Setting. 5th Fort Worth, TX: Human Milk Banking Association of North America; 2024.
  12. Cossey V, Jeurissen A, Thelissen MJ, Vanhole C, Schuermans A. Expressed breast milk on a neonatal unit: a hazard analysis and critical control points approach. Am J Infect Control. 2011;39(10):832-838.
  13. Oza-Frank R, Kachoria R, Dail J, Green J, Walls K, McClead RE Jr. A quality improvement project to decrease human milk errors in the NICU. Pediatrics. 2017;139(2):e20154451. doi:10.1542/peds.2015-4451
  14. Boullata JI, Carrera AL, Harvey L, et al. ASPEN safe practices for enteral nutrition therapy. J Parenter Enteral Nutr. 2017;41:15-103.
  15. National Association of Neonatal Nurses. The use of human milk and breastfeeding in the neonatal intensive care unit. Position statement #3065. April 2015. Accessed August 19, 2024. https://nann.org/uploads/About/PositionPDFS/1.4.3_Use%20%20of%20Human%20Milk%20and%20Breastfeeding%20in%20the%20NICU.pdf
  16. Bartick M, Hernandez-Aguilar M, Wight N, et al. ABM Clinical Protocol #35: Supporting breastfeeding during maternal or child hospitalization. Breastfeeding Med. 2021;16(9):664-674.
  17. The Joint Commission. The Joint Commission Comprehensive Accreditation and Certification Manual 2024 (E-dition). https://e-dition.jcrinc.com. Accessed August 30, 2024.
  18. The Joint Commission. National Patient Safety Goals Effective January 2024 for the Hospital Program. Accessed September 22, 2024. www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2024/npsg_chapter_hap_jan2024.pdf
  19. The Facilities Guidelines Institute. Guidelines for Design and Construction of Hospitals, 2022 Edition. ISBN: 978-0-9991 355-7-0
  20. US News and World Report. Methodology: US News and World Report best children’s hospitals 2023-2024. Accessed September 22, 2024. https://health.usnews.com/best-hospitals/pediatric-rankings
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  22. US Food & Drug Administration. Cronobacter sakazakii. Accessed September 22, 2024. www.fda.gov/food/foodborne-pathogens/cronobacter-sakazakii
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  28. Agency for Healthcare Research and Quality. Types of Health Care Quality Measures. Accessed September 22, 2024. ahrq.gov/talkingquality/measures/types.html
  29. Moro GE, Arslanoglu S, Bertino E, et al; American Academy of Pediatrics, European Society for Paediatric Gastroenterology, Hepatology and Nutrition. XII. Human milk in feeding premature infants: consensus statement. J Pediatr Gastroenterol Nutr. 2015;61(suppl 1):S16-19.
  30. Malone A, Carney LN, Carrera AL, et al. ASPEN enteral nutrition handbook. 2nd ed. American Society for Parenteral and Enteral Nutrition; 2019.
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  34. Konwinski L. Medication safety and the independent double check: a work system analysis and reliability engineering theory review. Proceedings of the 2020 International Symposium on Human Factors and Ergonomics in Health Care. 2020;9(1):119-120. www.ismp.org/ext/1375
  35. Citty SW, Chew M, Hiller LD, Maria LA. Enteral nutrition: An underappreciated source of patient safety events. Nutr Clin Pract. Published online April 26, 2024. Accessed June 13, 2024.
  36. Lawrence RM. Transmission of infectious diseases through breast milk and breastfeeding. In: Lawrence RA, Lawrence RM, eds. Breastfeeding: A Guide for the Medical Profession. 9th ed. Maryland Heights, MO: Elsevier Mosby; 2022:393-456.
  37. Jaffe, S. US infant formula crisis increases scrutiny of the FDA. Lancet 2022, 399, 2177–2178.
  38. US Food and Drug Administration. FDA Investigation of Cronobacter Infections: Powdered Infant Formula. 2022. Accessed September 22, 2024. www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022

Learn more about Timeless Medical Systems

The Timeless Medical Systems bar code scanning system offers a variety of reports that can help healthcare organizations evaluate their near-miss data and turn that knowledge into process change. In addition, Timeless Medical Systems also offers preparation room consulting services.
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The material presented in this blog represents the opinion of the author(s) and not necessarily the views of Synova Associates. Synova Associates does not endorse any specific products or organizations but strives to connect its industry partners with leaders interested in product/educational innovation.

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