Regulatory Requirements and Best Practices for Infant Feeding Preparation in the Hospital Setting
By: Caroline Steele, MS, RD, IBCLC, FAND and Suzanne Smith, MS, RD, LDN, IBCLC
While safe handling of human milk (HM) and infant formulas in the neonatal intensive care unit (NICU) setting may be assumed, when scrutinized, many practices fall short of current regulatory standards and published best practices. Three primary areas of concern with regards to infant feedings in the hospital setting are avoiding microbial contamination, ensuring preparation accuracy, and preventing misadministration (wrong HM or fortifier/formula administered). Implementing processes to address these concerns not only improves patient safety but also ensures that regulatory requirements and best practice recommendations are being met.
Healthcare Accreditation Organizations
Healthcare organizations are typically accredited by an independent organization that evaluates the safety and quality of care. Such accreditation is typically required for insurance reimbursement. The most common accrediting body within the United States is The Joint Commission (TJC) with the DNV National Integrated Accreditation for Healthcare Organizations (NIAHO®) and Accreditation Commission for Health Care and Healthcare Facilities Accreditation Program (ACHC-HFAP) rounding out the top three.1-3 Each of these organizations has standards applicable to the preparation and administration of infant feedings within the healthcare setting.
All three of these accrediting organizations state that feedings must be prepared in a proper location to support aseptic technique and that meets all standards for food preparation within the hospital in alignment with best practice guidelines.1-3 Feeding preparation at the bedside does not meet the criteria of any accrediting body. Human milk and formula preparation should occur in a dedicated space, away from direct patient care areas, that supports aseptic technique and is used solely for the purpose of infant feeding preparation.
In addition, TJC also addresses verification of feedings prior to administration. The National Performance Goal (NPG) 02.03.01 (formerly National Patient Safety Goal .01.01.01) specifies that a minimum of 2 patient identifiers must be confirmed for human milk administration.1 This standard also specifies that a minimum of 2 patient identifiers must be confirmed when providing care, treatment, and services.1 Because infant feedings are a prescribed care/treatment within the hospital setting, many organizations believe this standard indicates that any feeding (expressed human milk, pasteurized donor human milk, and infant formula) should be confirmed via two-person verification or bar code scanning before administering.
Other Regulatory Agencies
Other state and federal regulatory agencies also have standards applicable to the management of infant feedings within the hospital setting.
U.S. Food and Drug Administration (FDA)
The FDA maintains regulatory and enforcement responsibility over infant formula manufacturing and distribution safety.4 As part of that oversight, the FDA requires organizations to have a process for responding to recalls.4,5 To meet this requirement, hospitals must be able to identify not only what lot numbers were received by the facility, but which lot numbers were fed to patients and sent home as product samples.6 To track lot numbers for each feeding, many organizations utilize bar code scanning technology for all pasteurized donor human milk/donor human milk fortifiers, formula, and fortifiers/additives both at the time of preparation and the time of feeding to capture lot numbers and prevent any recalled items from being used. If bar code scanning is not in use, lot numbers for all products should be manually recorded. Of note, a recall may be issued months after a specific lot number has been available within the facility. Patients who received the recalled product may already be discharged. Therefore, hospitals must have methods to not only identify current patients, but also discharged patients, who received the recalled product in order to conduct and document proper follow up.6Recently, hospitals have reported unannounced on-site investigations from FDA Consumer Safety Officers to confirm the hospital’s ability to identify individual patients who received recalled items.6
Following the 2022 infant formula shortage, the Food and Drug Omnibus Reform Act of 2022 (FDORA) was enacted to strengthen the oversight of critical foods. This act created a new Office of Critical Foods within the FDA and explicitly reinforced the importance of recall management for hospitals. Under FDORA, hospitals are required to identify and track all recalled items, execute recall instructions, and maintain meticulous records.7) This new legislation aligns with the shift toward a data-driven approach to compliance, moving beyond written policies to actively demonstrating and documenting effective recall management, which is a key component of the new “Show Me, Don’t Tell Me” survey style from The Joint Commission.1
State Agencies
Most states have multiple agencies that have regulatory authority over healthcare organizations. State agencies that provide approval for construction within hospitals often have criteria that must be met for any new construction or remodeling project. Hospitals often use the criteria from the Facility Guidelines Institute (FGI) for construction projects and many states use the FGI Guidelines as their state requirements. Since 2010, the FGI has indicated that any NICU should have a separate feeding preparation space away from the bedside.8
Individual states’ Department of Health may have responsibility for surveying hospitals including evaluation of all food and nutrition preparation operations. In addition, most states require that human milk misadministration, which constitutes a bodily fluid exposure, must be reported to the state. To prevent human milk administration errors, hospitals should ensure two-person verification or bar code scanning of all human milk.
Professional Organization Best Practice Recommendations
American Academy of Pediatrics (AAP)
According to the 2023 AAP Standards for Levels of Neonatal Care: II, III, and IV, the facility shall provide a specialized area or room, with limited access and away from the bedside, to accommodate mixing of formula or additives to human milk.9 The facility will also have policies and procedures in place for accurate verification and administration of human milk and formula, and to avoid misappropriation.9
Institute for Safe Medication Practices (ISMP)
ISMP published recommendations for safe handling of infant feedings in 2024 which recommended hospitals implement centralized preparation with dedicated technicians when any preparation is required.10 ISMP suggests hospitals Implement bar code scanning for all expressed human milk, pasteurized donor human milk, and formulas at the time of preparation and the time of feeding to alert if it is the wrong feeding (wrong HM or formula), the feeding is expired, or if any component has been recalled.10 In addition, recommendations are to select technologies that allow for the automatic recording and tracking of lot numbers and that can provide data tracking in the event of a recall.10
Academy of Nutrition and Dietetics
Published guidelines from the Academy of Nutrition and Dietetics indicate that infant feeding preparation should be in a dedicated space away from the patient bedside that supports aseptic technique.4 Dedicated technicians and use of technology to prevent errors are also recommended practices.4
American Society for Enteral and Parenteral Nutrition (ASPEN)
ASPEN recommends that hospitals implement centralized feeding preparation with dedicated technicians and bar code scanning to promote patient safety and prevent errors.11 ASPEN notes that the use of technology, including bar code scanning systems, may reduce risk by confirming correct feedings are being prepared and administered.11 Recommendations include choosing systems that allow for the automatic recording of lot numbers and the tracking of metrics, including near misses.11 ASPEN notes that bar code scanning of enteral nutrition containers “supports both the physical and cognitive efforts of nurses and other caregivers involved in maintaining safe practices around enteral nutrition administration.”12
Recognition and Designations
Many hospitals seek recognition or designation from various organizations highlighting specific programs within the institution. One example of recognition is the U.S. News and World Report Best Hospitals Rankings and Ratings. Hospitals seeking recognition for neonatology are asked:13
- Does your hospital offer a dedicated area within the facility but away from the bedside for milk and formula preparation? To answer “Yes” this area must meet both of the following criteria:
- Infant feeding prep room using the aseptic technique
- Room requires restricted access and healthy personnel with no other activity occurring in the room
- Does your NICU program a specific risk reduction program that includes processes designed to reduce breast milk errors?
- Bar code system for correct identification of human milk
- Dedicated breastmilk technician who prepares milk for proper identification & distribution
Another hospital designation is from the Health Information Management Systems Society (HIMSS). HIMSS designates hospitals in stages zero through 7 (with 7 being the highest designation).14 Stage 7 status indicates that “an organization has established strong data-driven capabilities and is using technology in a useful and meaningful way.” 14 HIMSS has published best practice case studies which highlight the use of bar code scanning for both human milk and formulas from hospitals who have obtained HIMSS stage 7 designation multiple times and who have won their highest honor (the Davies Award) emphasizing the role of scanning in patient safety.15
Conclusions
Regulatory standards and best practice recommendations advise hospitals to prepare human milk and formula feedings in a centralized location away from the bedside (ideally with dedicated technicians) and the use of bar code scanning to reduce risk of microbial growth and prevent errors. Research supports these recommendations by showing centralized preparation of feedings results in lower incidence of microbial growth with feedings prepared centrally and significantly fewer errors.6,16-18 Furthermore, studies highlight how frequently clinicians attempt to use the wrong human milk/formula or expired items at both the time of preparation and feeding, emphasizing the importance of scanning all feeding items to prevent such errors from reaching the patient.6,17,18
Timeless Medical Systems offers expert guidance, software solutions, and staff education to help you and your team meet regulatory standards and best practice guidelines to ensure you are providing the highest standard of infant feeding safety. To learn more, please visit www.timelessmedical.com or email sales@timelessmedical.com.
References
- The Joint Commission. Requirements for the Hospital Accreditation Program. HAP Standards Report Jan 2026. Accessed August 20, 2025.
- NIAHO Accreditation Requirements, Interpretive Guidelines & Surveyor Guidance for Hospitals. Rev 25-0. April 28, 2025.
- Accreditation Requirements for Acute Care Hospitals, 2021 ed.
- Pediatric Nutrition Practice Group. Steele C, Collins E, eds. Infant & Pediatric Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. Chicago, IL. Academy of Nutrition and Dietetics, 2019.
- US Food & Drug Administration. 2022 Food Code. Food Code 2022 | FDA. Accessed Feb 4, 2025.
- Steele C, Bixby C. Bar Code Scanning of Human Milk and Enteral Formulas Improves Efficiency and Patient Safety: A 7-Year Review. Nutr in Clin Pract. 2022;37(4):921-928. https://doi.org/10.1002/ncp.10765.
- US Food & Drug Administration. Status Update on FDA’s Infant Formula Response Activities. Accessed Feb 4, 2025.
- Facility Guidelines Institute. Recommended Standards for Newborn ICU Design, 9th ed. Recommended NICU Standards_2020-08-31. Accessed August 20, 2025.
- American Academy of Pediatrics. Stark AR, et al. Standards for Levels of Neonatal Care: II, III, and IV. Pediatrics. 2023;151(6):e2023061957.
- Use barcode scanning to prevent errors with enteral nutrition feedings. ISMP Medication Safety Alert! Acute Care. 2024;29(16):1-5. Use Barcode Scanning to Prevent Errors with Enteral Nutrition Feedings (ecri.org).
- ASPEN Clinical Practice Tool Barcode Scanning for EN – ASPEN. Accessed August 20, 2025.
- Boullata J, et al. ASPEN Safe Practices for Enteral Nutrition Therapy J Parenteral Enteral Nutr. 2017;41(1):15-103.
- US News and World Report. Section F-Neonatal Care Survey. 2025 Pediatric Hospital Survey. Paper Survey – US News Pediatric Survey. Accessed August 20, 2025.
- EMRAM Criteria. himss-emram-criteria.pdf. Accessed August 20, 2025.
- Hocking C, Steele C. Infant Feeding and Enteral Feeding Safety Case Study. HIMSS Southern California Resource Center. Infant Feeding and Enteral Feeding Safety Case Study | HIMSS. Accessed August 20, 2025.
- Steele C, Short R. Centralized Infant Formula Preparation Room in the Neonatal Intensive Care Unit Reduces Incidence of Microbial Contamination. J Am Diet Assoc. 2008;108:1700-1703.
- Oza-Frank R, et al. A Quality Improvement Project to Decrease Human Milk Errors in the NICU. 2017;139(2):S1-S13.
- Steele C, Alessi S. Use of Dedicated Technicians and Bar Code Scanning Technology for Fortified Human Milk Feeding Preparation in a Neonatal Intensive Care Unit Reduces Risk of Preventable Adverse Events. J Acad Nutr Diet. 2024;124(5):559-563.
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