A Quality Improvement Project to Decrease Human Milk Errors in the NICUReena Oza-Frank, PhD, RD, a, b, c Rashmi Kachoria, MPH, a, b James Dail, CLSSBB, MBA, d Jasmine Green, RN, RNC-NIC, BSN, e Krista Walls, RN, RNC-NIC, BSN, e Richard E. McClead Jr, MD, MHAd, e

aCenter for Perinatal Research, bResearch Institute,

and dQuality Improvement Services, and eDivision of

Neonatology, Nationwide Children's Hospital, Columbus,

Ohio; and cDepartment of Pediatrics, College of Medicine,

The Ohio State University, Columbus, Ohio

Dr Oza-Frank conceptualized and designed the

study, oversaw data analyses, and drafted the initial

manuscript; Ms Kachoria carried out the initial

analyses and reviewed and revised the manuscript;

Mr Dail provided critical comments on the analysis;

Ms Green and Walls contributed to data collection

and interpretation; Dr McClead conceptualized and

designed the study; and all authors approved the

fi nal manuscript as submitted.

DOI: 10.1542/peds.2015-4451

Accepted for publication Aug 22, 2016

Address correspondence to Reena Oza-Frank, PhD,

RD, Nationwide Children’s Hospital, 700 Children’s

Dr, Columbus, OH 43205. E-mail: reena.oza-frank@

nationwidechildrens.org

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online,

1098-4275).

Copyright © 2017 by the American Academy of

Pediatrics

FINANCIAL DISCLOSURE: The authors have

indicated they have no fi nancial relationships

relative to this article to disclose.

FUNDING: No external funding.

POTENTIAL CONFLICT OF INTEREST: The authors

have indicated they have no potential confl icts of

interest to disclose.

Human milk feeding, considered

the optimal nutrition for infants,

is recommended by the American

Academy of Pediatrics 1 and the World

Health Organization. 2 It is also part

of the Healthy People 2020 national

health agenda. 3 For preterm infants,

human milk reduces the incidence of

necrotizing enterocolitis, improves

feeding tolerance, promotes cognitive

development, 4 – 7 and decreases

respiratory tract infections and

sepsis. 8 As a result, many hospitals

have significantly increased their

human milk feeding rates over the

past 10 years. 9, 10

Similar to national breastfeeding

trends, NICU breastfeeding rates

have also recently increased. 11 Often,

expressed human/breast milk (EBM)

is the only option during the early

postnatal period for NICU-admitted

infants due to oral feeding restrictions.

Ensuring safe EBM in the NICU is a

complex process; EBM needs to be

abstractBACKGROUD AND OBJECTIVE Ensuring safe human milk in the NICU is a complex

process with many potential points for error, of which one of the most

serious is administration of the wrong milk to the wrong infant. Our

objective was to describe a quality improvement initiative that was

associated with a reduction in human milk administration errors identified

over a 6-year period in a typical, large NICU setting.

METHODS: We employed a quasi-experimental time series quality improvement

initiative by using tools from the model for improvement, Six Sigma

methodology, and evidence-based interventions. Scanned errors were

identified from the human milk barcode medication administration system.

Scanned errors of interest were wrong-milk-to-wrong-infant, expired-milk,

or preparation errors. The scanned error rate and the impact of additional

improvement interventions from 2009 to 2015 were monitored by using

statistical process control charts.

RESULTS: From 2009 to 2015, the total number of errors scanned declined

from 97.1 per 1000 bottles to 10.8. Specifically, the number of expired

milk error scans declined from 84.0 per 1000 bottles to 8.9. The number of

preparation errors (4.8 per 1000 bottles to 2.2) and wrong-milk-to-wrong-

infant errors scanned (8.3 per 1000 bottles to 2.0) also declined.

CONCLUSIONS: By reducing the number of errors scanned, the number of

opportunities for errors also decreased. Interventions that likely had

the greatest impact on reducing the number of scanned errors included

installation of bedside (versus centralized) scanners and dedicated staff to

handle milk.

QUALITY REPORTPEDIATRICS Volume 139 , number 2 , February 2017 :e 20154451

To cite: Oza-Frank R, Kachoria R, Dail J, et al.

A Quality Improvement Project to Decrease

Human Milk Errors in the NICU. Pediatrics. 2017;

139(2):e20154451

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OZA-FRANK et al

received, stored, and prepared with

fortifiers or additives, and the bottles

combined/divided before feeding.

There is potential for error at any

of these steps. When considering

the large volume that is handled to

feed many infants, each receiving

multiple feedings per day, this risk is

compounded. 12 Medication errors are

3 times more likely in hospitalized

children compared with adults, 13

ranging from 5% to 27% of hospital

stays. Because human milk is treated

in a similar fashion to medications for

hospitalized infants, 14 a similar error

frequency may also extend to human

milk handling and administration.15

One of the most serious human milk

errors that can occur is administration

of the wrong milk to the wrong infant.

This can result in the transmission of

infectious diseases that may be present

in human milk and leads to in-depth

infectious disease testing of the donor

mom, recipient infant, and recipient

mom as well as authorization to disclose

results to the recipient’s parents. Wrong

human milk administration errors

can erode the trust and confidence of

patient families and result in increased

costs from additional tests. 16

In 2008, the NICU at Nationwide

Children’s Hospital (NCH) in

Columbus, Ohio began a quality

improvement (QI) initiative in

an attempt to eliminate errors of

the wrong milk being scanned in

response to actual breast milk errors

reported by nursing staff voluntarily

through the hospital event reporting

system. The purpose of the initiative

was to decrease errors and the

number of opportunities for actual

errors. 17 This report describes the

interventions targeted at eliminating

scanned wrong milk errors and

improving overall breast milk safety.

METHODS

Context

NCH is an academic, nonprofit, free-

standing children’s hospital located

in Columbus, Ohio. Annually, the

total inpatient and outpatient visits

at NCH exceed 1.3 million. Neonatal

services (neonatology) is a joint

venture between NCH and central

Ohio maternity hospitals. It is one

of the largest neonatal intensive

care programs in the United States

with >250 neonatal beds. The

main campus NICU consists of 114

neonatal beds divided among 3 level

IIIC NICUs with >2100 neonates

admitted per year. Twenty percent

of these infants weigh ≤1500 g at

birth, and >30% have major surgical

problems. Currently, the NCH NICU

consistently administers >6000

human milk feedings monthly, and up

to 60% of infants are on human milk

at any given time. 18, 19

Interventions

The original breast milk

administration process included

handwritten labeling of milk bottles,

and preparation/administration

of bottles by nursing staff, without

dedicated space to thaw, prepare,

and warm the bottles. Thus, in

response to actual breast milk errors

reported by nursing staff voluntarily

through the hospital event reporting

system in 2008, a multidisciplinary

QI team was established. The team

consisted of representatives from

clinical nutrition and lactation,

neonatology (including nursing staff),

information systems, and QI services.

Using tools from the Institute for

Healthcare Improvement Model for

Improvement 20 and Six Sigma, 21 the

QI team flowcharted the original

process of collecting, storing, and

administering breast milk; examined

existing policies related to the

process; and identified areas in the

workflow where the system failed

(failure mode effects analysis). 22 The

QI team identified key processes and

implemented several strategies to

reduce error rates.

First, the QI team revised and

updated the EBM storage and

handling process. Second, they

sought approval from the hospital

administration to purchase

the Timeless Medical Systems’

electronic breast milk tracking

system (a barcode medication

administration system [BCMA]

known as “Women and Infants”

[W&I]). W&I was chosen because

it allows for comprehensive

tracking of EBM bottles. The team

was confident that the decision

to implement W&I would have a

dramatic effect on reducing the

number of wrong-milk-to-wrong-

infant errors. The effort to reduce

scanned and actual errors was based

on previously defined best practices

for breast milk administration. 23, 24

W&I was implemented for use

by nurses to check in, prepare,

and administer EBM feedings via

centralized scanners. At this time,

bedside medication barcoding was

unavailable in the NICU; therefore,

to use W&I optimally, scanners

had to be purchased. Because of

budgetary constraints, only a limited

number of scanners were initially

purchased. These were installed in

centralized locations throughout the

NICU. Training and implementation

of W&I took a few months to assess

small processes of change needed

before full implementation. The

partial implementation of W&I in

2009 provided a baseline scanned

error rate, which was used to

assess subsequent improvement

interventions to reduce scanned and

actual errors. Scanned errors were

then documented and graphed on

statistical process control charts.

Six months after W&I implementation

(April 2010), the nursing staff began

using magnets on the outside of the

breast milk refrigerators to identify

the location of patient feeding bins

in an attempt to reduce the risk of

inadvertently selecting the wrong

bottle. Additionally, in July 2011,

additional scanners were purchased

and installed at each bedside,

which eventually were used to scan

medications.

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PEDIATRICS Volume 139 , number 2 , February 2017

In 2011, another actual wrong-

milk-to-wrong-infant error

occurred. A full root cause

analysis was completed with a

detailed timeline of events and

identification of individual and

system related causal factors. A

revised comprehensive human

milk handling and storage

process (exclusive of donor milk)

was developed and audited for

compliance ( Fig 1). Moreover,

the process for the evaluation

and follow-up of wrong human

milk administration errors was

standardized. In addition, a full-

time dedicated milk technician was

hired, and plans for a centralized

milk room were developed.

Measures and Analysis

The W&I system provides 66

possible scanned error codes. Ten

codes were evaluated as “critical

errors.” These were grouped into 3

categories: human milk expiration,

wrong milk to wrong infant, and

human milk preparation ( Table 1).

The monthly error rate, the primary

outcome metric, was defined as the

number of errors scanned in the

W&I system divided by the total

number of bottles fed per month as

logged in W&I. The scanned error

rate and the impact of additional

improvement interventions from

2009 to 2015 were monitored by

using statistical process control

charts. Control charts were

generated for the total number

of scanned errors, as well as for

each individual category of errors.

A Laney adjustment was used to

account for overdispersion in the

data. We used a combination of

linear regression, the 6 successively

increasing or decreasing points

rule, and the 8 consecutive points

rule to assess trends and shifts

in the data. The first 3 months of

error data were not included in the

centerline/control limit calculations

because they reflected a W&I system

software and hardware training

period.

The main process measure was to

estimate the concordance between

the numbers of bottles fed as

reported from either W&I or from

medical records. The number of

scanned errors compared to the

breast milk errors documented in

the hospital event reporting system

was also measured to determine

if the number of voluntarily

reported errors followed a similar

pattern.

e3

FIGURE 1Current breast milk management and administration workfl ow, NCH. DBM, donor breast milk; MOMS, barcoding system (BCMA); PCA, patient care assistant; RN, registered nurse.

TABLE 1 Error Codes in the W&I System Identifi ed as Critical Errors

Error Category Human Milk Expiration Wrong Milk/Wrong Infant Human Milk Preparation

W&I error messageThe bottle that you

selected has expired.

This bottle is assigned to

another infant.

The bottle that you

selected has already

been thawed and

cannot be refrozen.

The bottle cannot be fed

to the infant as it is

currently frozen.

The bottle is not from the

mother of this infant.

You are attempting to

combine fortifi ed and

nonfortifi ed bottles.

The bottle cannot be

received as it is

already expired.

The item does not belong

to the person.

You are attempting

to combine bottles

that have different

fortifi cations.

The bottle that you

selected has already

been fortifi ed and

cannot be frozen.

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Ethical Issues

This QI work involved implementing

evidence-based interventions or

best practices designed to reduce

and ultimately eliminate human milk

administration errors for neonates

admitted to NCH neonatal services.

Therefore, per human research

protection program policy, this QI

project was not considered human

subjects’ research, and formal

approval by the institutional review

board was not required.

RESULTS

From 2009 to 2015, the most

common scanning errors identified

were due to expired milk, wrong-

milk-to-wrong-infant, and

preparation errors, respectively ( Fig

2). During this time period, the total

number of scanned errors declined

from 97.1 errors per 1000 bottles

to 10.8 ( Fig 2). Specifically, the

number of expired milk error scans

declined from 84.0 per 1000 bottles

to 8.9. The number of preparation

(4.8 per 1000 bottles to 2.2) and

wrong-milk-to-wrong-infant errors

scanned (8.3 per 1000 bottles to 2.0)

also declined. These scanned error

rates have been sustained through

2015. The first centerline shift was

observed in June 2011, in conjunction

with the implementation of bedside

scanners ( Fig 3). The second shift

was a continuous downward

trend observed in 2012 after the

implementation of a dedicated full-

time milk technician. This trend was

interrupted after only 5 points, but

then continued after a small 1-point

reversal. The application of linear

regression to the entire 8-point slope

from March 2012 to December 2012

(constrained at the end points to

intersect the 2 flat stages, exactly as

plotted) yielded a highly significant

result (P < .001), making it clear that

we do indeed have a valid downward

trend. Therefore, we have plotted the

centerline to conform accordingly

(trend identification with regression

confirmation is built into our control

charting tool, so this did not require

separate analysis).

Control charts for each individual

category of errors scanned indicate

that the decrease in errors scanned

related to expired milk was

associated with the use of magnets

on the outside of the breast milk

refrigerators and the implementation

of dedicated milk technicians

(Supplemental Figs 4–6). Similarly,

the decrease in scanned milk

preparation errors was also primarily

associated with the hiring of a milk

technician. Finally, the decrease

in scanned wrong milk errors was

associated with the installation of

bedside scanners.

In terms of process measures, we

found ∼92% to 100% concordance

between the number of bottles

scanned (data directly from W&I)

and the number of bottles fed

(abstracted from medical records),

indicating W&I is capturing the vast

majority of bottles fed on a regular

basis. We also examined the number

of all documented breast milk errors

in the hospital event reporting

system to determine if the number

of voluntarily reported breast milk

errors also declined. Although

the event reporting system began

before 2013, the W&I system was

not fully implemented on all units

administering breast milk until 2012.

In 2013, data were categorized with

more granularity to allow for more

specific categorization of breast milk

errors. We found that the number

of voluntarily reported events also

declined from 58 in 2013 to 29 in

2015.

DISCUSSION

We observed a decrease in the

number of wrong milk errors

scanned from 2009 to 2015. We also

observed a decrease in the number of

errors scanned related to breast milk

expiration and preparation. Before

the W&I system implementation,

these errors were unrecognized.

Declines in voluntarily reported

breast milk errors during the same

time period corresponded with the

decreases in scanned errors. These

decreases in scanned errors were

primarily associated with 2 specific

interventions: installation of bedside

scanners and hiring of staff dedicated

e4

FIGURE 2Breast milk errors scanned, 2009 to 2015. Data were based on errors scanned in the breast milk BCMA. After examining all 66 possible error codes in the BCMA, 3 categories of errors were identifi ed: human milk expiration, wrong milk to wrong infant, and human milk preparation ( Table 1).

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PEDIATRICS Volume 139 , number 2 , February 2017

to handle milk. Although examining

scanned errors does not explicitly

indicate a reduction in actual errors,

such data indicate reductions in

opportunities for actual errors to

occur.

Current recommendations and

reports of best practices suggest

that centralized handling and

use of barcode scanning improve

human milk patient safety 23, 24 and

contribute to time and cost savings. 12

Thus, our interventions followed

these recommended best practices.

For example, hiring dedicated staff

to handle milk was associated with

decreases in milk preparation and

expiration scanned errors. Similarly,

installation of bedside scanners

was associated with decreases in

wrong milk errors. Both of these

interventions highlight the need to

effectively implement change(s) into

the workflow of the unit.

Barcoding is recommended by

the Institute of Medicine as a

safety intervention and “proactive

approach” to prevent problems with

patient identification. 25 The Joint

Commission also lists barcoding

as a way to meet National Patient

Safety Goal 1. 26 In response to

these recommendations, BCMA

systems are applicable to breast milk

because breast milk is considered

medicine. 14 Others have shown

that BCMA systems for human milk

reduce wrong milk errors. 17, 24, 27

As our study and other studies

have demonstrated, 24 BCMA

has highlighted new, previously

unmonitored scanned errors, such

as the potential for feeding expired

milk 24 or incorrectly prepared milk.

As with medications, attention must

be paid to the expiration date on

human milk. 28 With every freeze/

thaw cycle of milk processing, some

of the protective properties (such as

antibodies) are destroyed, increasing

the susceptibility of contamination,

overgrowth of harmful bacteria,

and risk of infection. 29 As a result,

NICUs must follow conservative

shelf-life recommendations to

protect their immune-compromised

patients. Moreover, incorrect milk

preparation, such as combining

bottles that have already been

fortified, has the potential to

expose infants to inappropriate

micronutrient concentrations that

can cause harm. 30 – 33

e5

FIGURE 3Annotated control chart (u-chart) depicting the breast milk error rate. Data were based on errors scanned in the breast milk BCMA (bar code medication administration). PCA, patient care assistant. a Control limits are wider (or narrower) than standard because data variation in ≥1 baselines is too large (or too small) to meet usual u-chart statistical assumptions.

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OZA-FRANK et al

A risk of BCMA systems is the

potential to develop work-arounds

to circumvent the system and bypass

safety features. 28 For example,

to facilitate the patient scanning

process, staff may place a patient’s

printed ID band on a report sheet

and scan it instead of the band

attached to the patient. Most nurses

manage >1 patient at a time, and

thus, by not scanning the infant ID

band attached to the patient, they

risk scanning the wrong patient

band. A second example is the ease

of skipping the disposal step for

expired milk. If an expired bottle is

scanned, an error appears on the

screen. This should be a hard stop

to additional milk preparation and

feeding. Ideally, the expired bottle

should be disposed before scanning

a new bottle for feeding. However,

after an expired error is logged, the

system does not force disposal of

the expired milk. These occurrences

of expired milk are monitored and

manually reviewed by nursing staff to

determine if the proper procedures

were followed.

The generalizability of this study is

limited, because not all NICUs have a

BCMA. The expense associated with

implementing a human milk BCMA

may be more appropriate for larger

units and systems such as ours. Costs

associated with the human milk

BCMA include software, hardware,

and staff time. Conservatively, the

initial costs of a human milk BCMA

system for a small- to mid-sized

NICU could range from $100 000 to

$200 000 with an additional $50 000

to $100 000 annually for ongoing

support.

The success of this initiative was

also influenced by the culture of

safety established at NCH in 2009

with the implementation of our

“Zero Hero” program to eliminate

preventable patient harm. 20, 34

Because the implementation of

this safety program preceded the

implementation of W&I system, the

clinical staff were already focused on

QI and patient safety.

Although we observed a decrease in

the scanned human milk error rate,

our rate is not 0. Recently, we have

begun tracking errors specific to

donor breast milk. The local human

milk bank implemented the same

BCMA technology used by NCH. This

allows seamless use of donor milk

bottles. Additionally, the W&I system

is used not only on our main campus

(the focus of this study) but also in

the satellite nurseries/NICUs that are

managed by NCH in birth hospitals

throughout Columbus, Ohio. Error

rates at these satellite units have not

yet been examined. Finally, NCH has

plans to integrate feed orders from

the electronic medical record into the

W&I system. This integration would

allow the milk technicians to have the

information for bottle preparation

(eg, fortification) within W&I,

eliminating the need to manually look

up each patient’s feed orders in the

medical record (which is our current

process).

By reporting human milk errors, an

uncommon practice in hospitals, 16, 27, 28

and the strategies to reduce them,

our study brings transparency in

sharing data to improve outcomes.

Sharing data between institutions

(“all teach, all learn”) can facilitate

rapid spread of best practices,

potentially achieving optimal

outcomes more quickly. 35 Without a

thorough understanding of the rates

of human milk errors, and which

human milk errors are occurring

at which point(s) in the process,

strategies to prevent harm are

difficult to implement.

CONCLUSIONS

We have shown a decrease in the

number of scanned human milk

administration errors after a series

of interventions. However, errors

still occur. Thus, additional efforts

are needed to additionally reduce

the scanned error rate to ultimately

eliminate errors. With human milk

feeding increasing among infants

admitted to the NICU, volumes of

milk will continue to increase as will

opportunities for errors. Patients and

families should be able to trust the

proper handling and administration

of this aspect of medical care. Thus,

continued efforts are needed to

improve and disseminate successful

strategies to ultimately eliminate

human milk administration errors.

ACKNOWLEDGMENTS

We thank Thomas Bartman, MD,

PhD, Vicky L. Armstrong, RN, MSN,

Christine Smith, BA, RN, IBCLC, ANLC,

Margaret R. Holston, RN, BSN, and

Margot Ranney, RN, for their support

and participation in the initial QI

efforts related to this project. We also

thank T. Arthur Wheeler, MS, MSES,

MBA, for statistical assistance and

Andrew Gilleon, BSECE, and Nicholas

Foor for assistance accessing data.

ABBREVIATIONS

BCMA:  barcode medication

administration system

EBM:  expressed human/breast

milk

NCH:  Nationwide Children’s

Hospital

QI:  quality improvement

W&I:  Women and Infants

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