The Cases 

Case #1:

A 29-day-old infant had an uneventful stay in the neonatal intensive care unit (NICU) after birth at 30 weeks gestation. He was fed exclusively with his mother`s expressed breast milk (EBM), partially orally, and the rest via gavage (nasogastric tube) feeding. The census in the step-down NICU was high, so each nurse was assigned 3 or 4 patients. This patient’s nurse was busy feeding another baby; he cried inconsolably of hunger despite his next feeding not being due until 30 minutes later. Another nurse stepped in to help, and because she was in a hurry, she did not follow the unit’s policy on scanning EBM step by step; she grabbed a bottle of milk provided by a different mother with a history of testing positive for hepatitis B surface antigen. The patient was fed EBM from the wrong mother, which resulted in exposure to potentially infectious breast milk. This error was not discovered until the patient’s primary nurse returned to document the quantity of milk consumed. The infant had earlier received his first dose of the hepatitis B vaccine; however, because of the exposure, the infectious diseases specialist recommended giving him hepatitis B Immunoglobulin and scheduling him for follow-up laboratory testing for Hepatitis B surface antigen at the age of 9 to 15 months. The patient’s family was included in a discussion to disclose the error, creating a safe space for questions that detailed the follow-up actions the medical team took after the error was disclosed and how the facility/NICU was planning to prevent similar errors in the future.

Case #2:

A 3-day-old male newborn was born at full term via spontaneous vaginal delivery. The newborn was fed breast milk for the first three days of life while the mother and baby remained in the hospital. The mother planned to exclusively breastfeed. However, upon discharge, the mother requested a can of powdered milk to use “until her milk came in.” The patient was offered but declined a lactation consultation visit to follow up on any breastfeeding concerns. The primary nurse asked a nursing student to bring a can of formula from the storage area. The student then went to show the can to the primary nurse and verified that it was the correct formula requested by the patient, type, and brand. However, before entering the patient`s room, the student noticed that the can of formula would expire the next day. She went back to the primary nurse, who replaced the can with a fresh one with a longer future expiration date. The whole batch of formula was discarded, and a safety report was filed.

The Commentary

By Marla Shauer, PhD, CNM, MSN, Diana Guzman Perez, MS, and Brenda Chagolla, RN, PhD, CNS, FACHE

Breastfeeding involves education of both the mother and infant and is a process that begins before birth with the mother’s decision to breastfeed and extends until the mother stops breastfeeding., Breastfeeding is recommended to continue for at least six months after birth by both the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).^1,2,3 As discussed in a previous PSNet WebM&M commentary, the practice of breastfeeding is the best solution to avoid breast milk errors.

Lack of clear information as to “how much milk” one’s infant is getting is a common issue, leading to the potential overuse of formula and misunderstandings about how to support mothers who plan to exclusively breastfeed.^4,5 In 1991, the WHO and UNICEF launched the “Baby-Friendly Hospital Initiative” and encouraged hospitals to follow the ten steps to support breastfeeding, including not providing breastfed infants any foods or fluids other than breast milk unless medically indicated.⁶ The Initiative recommends that hospitals attempting to be “Baby Friendly” abandon the common practice of sending formula home with mothers, as providing samples reinforces the false idea that breastfeeding exclusively does not provide sufficient nutrition for a newborn.⁶ The U.S. does not participate in the WHO International Code of Marketing Breast Milk Substitutes that prohibits infant formula companies from providing free products to healthcare facilities, staff, or sponsoring meetings.⁷ Providing breastfeeding mothers with free formula samples at discharge has been a common practice, especially in hospitals that are not designated as Baby-Friendly. Current evidence continues to describe the adverse effects of providing free formula to breastfeeding mothers at discharge including a 2.5-6 times higher risk for shorter duration of time the baby is breastfed.⁸

Per the CDC National Breastfeeding Report card, which gathers data on breastfeeding practices nationally, of infants who were born in 2019, 83.2% received at least some breast milk after birth and by one month of age, 78.6% were still receiving any breast milk.⁹ The CDC also collects and shares the national survey called Maternity Practices in Infant Nutrition and Care (mPINC), which measures different domains in newborn care and policies.¹⁰ In this survey, only about 28% of the participating hospitals had an ideal response of few breastfeeding newborns receiving infant formula, 59% of hospitals had an ideal response of counseling breastfeeding mothers who requested infant formula about possible consequences, 66% of hospitals had an ideal response of not giving mothers any of the following items as gifts of free samples: infant formula, feeding bottles/nipples, nipple shields, pacifiers, coupons, discounts or educational materials from companies that make or sell infant formula/feeding products, and 54% of participating hospitals pay a fair market price for infant formula.¹⁰ In another study conducted between 2017 and 2019 in Portugal, the marketing of formula was found to significantly decrease any breastfeeding and exclusive rates of breastfeeding in both native and migrant women; this study included nearly 2500 women across 32 maternity hospitals.¹¹

The discussion about human milk safety includes understanding why various alternatives, such as formula or pumped and stored milk, are utilized and how to administer the stored formula or pumped milk safely. The use of expressed breast milk, wherein the mother pumps breast milk to be given to their infant later, is used in a variety of settings both in and out of the hospital.¹²

The benefits of human milk feeding for infants are many and include decreased risk of respiratory illness, diabetes mellitus, and obesity.^3,13 Infants in a NICU further benefit from human milk by reducing the risk of necrotizing enterocolitis, late-onset sepsis, and chronic lung disease.³ It is common for the mother of a NICU patient to pump her breasts at home and bring the milk to the hospital for administration to her infant. Human breast milk, especially within the NICU setting, can be thought of as medicine, and as such, precautions must be in place to ensure safety when administering breast milk to patients.¹⁴ When expressed breast milk is given to the wrong baby, there is a risk of transmission of infectious diseases to the baby as happened in Case #1.¹⁵

Missed Opportunities

The first case highlights a missed opportunity for avoiding a milk administration error through ensuring nursing education and adhering to practices and policies in NICU environments. It is also possible that the nurse was rushing due to short staffing in the NICU, which is a systems issue that often contributes to patient safety concerns.¹⁶ It is not uncommon for a nurse who is not the primary nurse to have to step in and assist the primary nurse when they are busy. These are times when there is higher risks of errors being made as the nurse assisting may not know the entire background of the patient. In this case, failure to follow unit policy in scanning EBM led to administering EBM from the wrong mother who had a history of a positive hepatitis B surface antigen. Addressing system level challenges such as sufficient numbers of trained nurses to provide adequate staffing as well as ensuring a strong patient safety culture are essential. Educating nurses, not only on the appropriate policies and procedures but also about how “helping or covering during break episodes” can be high risk for error can help reinforce the need to follow policies designed to ensure safe care.¹⁷ Unfortunately, this infant had to be given hepatitis B Immunoglobulin and scheduled for follow-up laboratory testing for Hepatitis B surface antigen after discharge, which presents another potential risk if the parents are unable to follow through with the testing.¹⁸

In looking at the second case through the lens of preventing medical errors, this likely falls in the category of outcomes being “near-miss” or “no harm,” as the nearly expired formula was not provided, so no harm occurred to the mother/infant pair although this was appropriately described as a “near miss” since expiration would occur at 24 hours after maternal discharge.¹⁹ From this perspective, this was a good catch by the nursing student who noticed and reported the problem to the charge nurse who then intervened appropriately.

This case also involves several safety topics related to infant feeding, including breastfeeding education and supporting the experience of exclusive breastfeeding. Nurses have a great opportunity to educate the mother in the stages of breast milk supply changes, especially over the first week of life, as well as infant cues to feeding and satiety. Several other aspects of this case include the potential to give an exclusively breastfeeding mother formula that she would typically not require per baby-friendly hospital breastfeeding guidelines, as well as safety concerns regarding the formula with an expiration date that expires shortly after hospital discharge.Students, whether in nursing or medicine, should be educated as to unit procedures, how to support patients in exclusive breastfeeding and the provision of formula, and how to assist the team with educating the mother/infant or family unit in safe newborn feeding practices regardless of the method the mother/infant/family unit is utilizing.

Approaches to Improving Safety

Standardized Processes for Infant Feeding

Expressed breast milk being given to the wrong baby is a mistake that occurs more frequently when mother and infant are separated, such as in the NICU.¹⁴ NICUs typically have a standardized process in place to facilitate the provision of any type of infant feeding, which is intended to prevent expressed breast milk from being given to the wrong baby, These processes generally include best practices for EBM collection, including steps for collection, storage, and administration. There are a variety of electronic and manual methods that NICUs can utilize for the safe administration of expressed breast milk.²⁰

The Pennsylvania Patient Safety Authority described a comprehensive set of risk reduction strategies to prevent unintended exposure to the wrong-expressed breast milk.¹⁸ Although these strategies were developed in 2007 in response to about twenty reported events, most are still pertinent today.

Their strategies were organized into six categories:

1. Separation - minimize the separation of mother and baby
2. Identification - includes verifying correct demographic information of mother and infant, as well as milk expression timing.
3. Labeling - utilize labels that can be scanned electronically, including infant, mother, and milk labels. If manually written labels are used, consider using moisture-resistant ink, and generate consistent labels with clear data including name/date and time of expression.
4. Storage organization and management - maintain appropriately refrigerated storage facilities.
5. Dispensing practices - includes verifying dates/times when milk is dispensed.
6. Education and communication - educate staff and parents about labels and identification bands on both patients and milk.

Having an electronic scanning system can further contribute to patient safety by not only alerting the administering team members if they are administering the wrong breast milk but also by providing expiration notices. Recommended best practices include electronic scanning to validate and decrease errors.¹⁴ When performing manual methods, two-person checks with two patient identifiers can be considered.¹⁴ The standardized process for each hospital should be readily available in writing and communicated to all staff who manage expressed breast milk. If there are concerns or barriers to following the standardized expressed breast milk collection, storage, and administration process, clinicians are encouraged to speak up. Communication is important with ongoing training or retraining to ensure that all team members are up to date on the current protocols. In addition, checking for understanding by having team members show that they can follow the correct protocol when managing expressed breast milk can be beneficial.¹⁴

Sometimes, other staff in a hospital may be asked to assist with tasks such as feeding due to multiple factors, including decompensating patients, changing acuity, breaks, or other internal or external impacts on patient-nurse care ratios. Therefore, all potential staff or nurses are recommended to be included in training on standardized processes for tasks that include identifying expressed breast milk and processing EBM, as well as involving all facility staff who may be charting EBM or breastfeeding-related tasks.

Care team members should check identification bands before providing EBM and ensure that patients and babies maintain their identification bands.¹⁸ Hospitals should also use moisture-resistant ink pens and ensure that EBM is labeled clearly and consistently.¹⁷ Labels can also include the demographic information of the baby as well as the time the milk was expressed and the time the milk was thawed.¹⁸ Care team members can also verify with the parent that the label on the EBM container matches the parent’s identification information, along with the date and time that the EBM was expressed, and have staff provide their initials when giving the EBM to the baby.¹⁷

Best practices for preventing feeding errors include having dedicated lactation technicians to handle and prepare breast milk to reduce administration errors.¹⁴ However, in acute care hospitals, especially NICUs, it is busy and there is high acuity with a multitude of activities often occurring simultaneously. Sometimes nurses will need to assist with interventions or assignments due to breaks, decompensating patients, changing acuity, or assignment adjustments. Therefore, all nurses should follow standardized processes for tasks such as medication administration, lab specimen collection, and expressed breast milk administration.

Error Disclosure and Communication: 

Error disclosure impacts several parties in healthcare. First, for errors to be addressed, they must be recognized and reported appropriately so that something can be done to resolve the error and prevent it from happening the future. This starts with someone recognizing the error, reporting it, and then the health system acting upon it appropriately, often through a root cause analysis process. The healthcare team is also responsible for acknowledging errors and discussing them with the patients and families impacted by the error.²¹ This practice allows health team members to learn from their mistakes and keep patients informed.¹⁹ When discussing medical errors with patients, there are a few things to consider, beginning with the acknowledgment of the specific error, how that error impacted the patient, and that the specific communication includes taking responsibility for the medical error.²¹ It is also helpful to provide any mitigation steps being put in place to correct the error, if known.²¹

Staff who make and report an error to supervisors should not face punitive actions. Rather, any follow up actions taken by supervisors should reinforce the need for all team members to be alert and willing to disclose when errors do occur and to participate in error resolution and prevention processes when appropriate. Near misses may be characterized as good catches, thus rewarding staff who recognize and report, facilitating greater organizational learning. These actions, in turn, will continue to strengthen patient safety practices to support a safe environment.²¹ Healthcare team members who make an error can discuss it with the patient(s) but should also consider discussing the situation with a trusted colleague, managers/supervisors, and/or the team. Reflections on the error may also require the individual to practice self-care and allowing space for considering the situation while learning to set boundaries.²² Learning from such errors to improve patient safety is also an important aspect to consider.²¹ Evidence-based guidelines such as the AHRQ Communication and Optimal Resolution (CANDOR) process can help both individual staff and the organization to improve these processes. One best practice worth noting is creating opportunities for staff to participate in simulation activities to practice disclosure in a safe environment.

Best practices for communicating after patient safety errors have occurred may include the following:²¹

• Preparing for the discussion, including considering where to have the conversation and who to include.
• Providing clear and understandable information to patients and their families.
• Encouraging patients to ask questions and engage in open dialogue to ensure their understanding of the incident.

Take Home Points

• NICUs should use standardized processes to prevent expressed breast milk from being given to the wrong baby, such as electronic scanning workflows.
• Every member of the healthcare team is responsible for following the designated expressed breast milk administration process to decrease the risk of errors.
• After an error occurs, healthcare teams should have an open discussion with the patient and family as appropriate. Healthcare team members should also be provided support after an error occurs.
• Restructuring work environments by reducing high-workload duty hours can help reduce errors and increase patient safety.
• If formula is medically indicated, it’s vital to review its proper use, preparation, and safe expiration date before administration.
• The AHRQ CANDOR process can help organizations implement disclosure best practices.

Marla Shauer, PhD, CNM, MSN
Assistant Clinical Professor
Betty Irene Moore School of Nursing
UC Davis Health
mjshauer@ucdavis.edu

Diana Guzman Perez, MS
Student
UC Davis School of Medicine
dguzman@ucdavis.edu

Brenda Chagolla, RN, PhD, CNS, FACHE
Associate Chief Nursing Officer
Patient Care Services Administration
UC Davis Health
bchagolla@ucdavis.edu

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