40 ISE Magazine | www.iise.org/ISEmagazine

Is improvement methodology limited to only hard dol-

lar savings? Can methodologies such as Lean, Six Sigma

or ISO 9001:2015 save lives if leveraged properly? Is

waste the only application for improvement or are other

viable targets warranted? Is improvement only a pipe

dream or can it become a reality with the right struc-

ture, process and people focus? Can change agents realize

long-term improvement wins that stand the test of time even

in the face of a pandemic or is sustainability a mirage that

quickly fades with time?

We will answer these and other considerations in this article.

Several years ago, Atrium Health Navicent began a jour-

ney to achieve higher performance. The provider has more

than 1,000 beds for medical, surgical, rehabilitation and hos-

pice purposes, offers over 53 specialties in more than 50 facil-

ities throughout the region and hosts more than 100 medical

residents and fellows. Included within the system is Atrium

Health Navicent The Medical Center, a 637 bed, nationally

veriﬁed Level I-designated trauma center and a three-time

Magnet designated hospital for nursing excellence world-

wide.

The journey focused on this ﬂagship hospital for the health

Leveraging improvement efforts to reduce

hospital infections

Certiﬁcation process led to strategies that improved patient outcomes

By Sonya Floyd and Casey Bedgood

September 2022 | ISE Magazine 41

system. The ﬁrst step was to adopt methodologies such as

Lean and Six Sigma. Once hundreds of internal stakeholders

were trained, deployment occurred with the aim of improv-

ing the value equation, which at its core consists of service,

cost and quality.

The goal is to maximize the value provided to every cus-

tomer. This may be achieved by providing enhanced ser-

vices at lower costs with better health outcomes. Tactically,

improvement methodologies were used to address oppor-

tunities beyond the traditional process-related waste. Some

initiatives included the redesign of structure to accompany

process improvements and the like.

Once the basics were in place, the hospital pursued ISO

9001:2015 certiﬁcation and successfully passed the exam. In

2017, The Medical Center received this coveted designation

and began to elevate outcomes with an aggressive improve-

ment focus. The team focused heavily on the core elements

of ISO 9001:2015 as the catalyst for next level performance.

These core elements include, but are not limited to, attri-

butes such as a laser focus on customer requirements, involv-

ing top leadership in all improvement activities, leveraging

data to make evidence-based decisions, improving every-

thing, managing relationships for better outcomes and maxi-

mizing organizational knowledge.

The team began this journey by identifying top senior

leaders as ISO 9001:2015 ISO champions. Each year, these

leaders received various training and signed contracts out-

lining their obligations to the improvement journey. These

sponsors led the journey to ensure tollgates were reached and

that the organization matured with methodology.

The team also leveraged data to better inform stakeholders

of the current operating environment including perceived

and actual risks, hot spots that needed immediate attention

and segmenting real improvements from perceived improve-

ments. The goal was to remove thought, feeling or emotion

from organizational decision-making, thus allowing objec-

tive data to lead the way forward, prevent leaders from act-

ing when unnecessary and reacting appropriately when the

circumstances aligned.

Also, the team redeﬁned the term “customer.” Tradition-

ally in healthcare, the customer has always been the patient.

But in today’s world, is a patient the only customer? Are staff

and leaders also customers? Are vendors and contractors who

provide goods and services customers? Should government

agencies, regulatory entities and the like also be added to the

stakeholder list? The short answer is that “customer” applies

to all the above and more. Anyone who touches an organi-

zation directly or indirectly is essentially a customer. Thus,

reﬁnement of the customer concept was crucial in deﬁning

the improvement journey.

Finally, the team shifted focus and leaders invested count-

less time, effort and resources to capturing organizational

knowledge. In simplest terms, the hospital increased its docu-

mented policies, work instructions and the like by over 50%.

These guides for completing work were stored real time in a

knowledge management system accessible to all stakeholders

when needed and standardized with templates. The goal was

to create a culture of standard work, standardizing processes

and the way work is done.

Identifying improvement targets

Once the basics were in place and aligned with organization-

al culture, the team began to identify granular opportuni-

ties that would greatly improve the value equation for thou-

sands of customers annually. Two focus areas were hospital

infections such as C. diff (Clostridioides difﬁcile) and CAUTI

(catheter-associated urinary tract infections). The key is that

any infections are bad. The goal is for hospitals to avoid in-

fections, proactively prevent them from becoming worse, if

present, and eliminate these risks with proactive action plans.

Let’s deﬁne these target infections along the improvement

journey. The Centers for Disease Control and Prevention

(CDC) deﬁnes C. diff as “a germ (bacterium) that causes se-

vere diarrhea and colitis, an inﬂammation of the colon. Most

cases of C. diff infection occur while you’re taking antibiot-

ics or not long after you’ve ﬁnished taking antibiotics.” This

can be life-threatening if not treated properly, and preven-

tion, early detection and proper treatment are key for success.

The other infection targeted was CAUTI, which the CDC

deﬁnes as a urinary tract infection (UTI) “involving any part

of the urinary system, including urethra, bladder, ureters and

kidney. UTIs are the most common type of healthcare-asso-

ciated infection reported to the National Healthcare Safety

Share your healthcare solutions

at HSPI 2023

Do you have a healthcare systems improvement story or re-

search to share? Presentations are now being sought for the

Healthcare Systems Process Improvement Conference, Feb.

15-17, 2023, at the Kentucky International Convention Center

in Louisville, Kentucky.

Abstract submissions are due by Sept. 30. Learn more at

link.iise.org/hspi2023-abstracts and look for upcoming infor-

mation on speakers and program information at iise.org/HSPI.

42 ISE Magazine | www.iise.org/ISEmagazine

Leveraging improvement efforts to reduce hospital infections

Network (NHSN). Among UTIs acquired in the hospital,

approximately 75% are associated with a urinary catheter,

which is a tube inserted into the bladder through the urethra

to drain urine. Between 15%-25% of hospitalized patients

receive urinary catheters during their hospital stay. The most

important risk factor for developing a catheter-associated

UTI is prolonged use of the urinary catheter. Therefore,

catheters should only be used for appropriate indications and

should be removed as soon as they are no longer needed.”

The team realized that both infection rates were higher

than acceptable in this facility. A two-pronged approach was

pursued to lower both infection types. For C. diff, the team

focused heavily on early detection with testing. If infections

were identiﬁed, then treatment protocols were implemented

to mitigate the risk and seek to end the infection sooner.

Other techniques such as enhanced hand hygiene also

were implemented. This is a basic fundamental, but impor-

tant in addressing infections. Other cleaning procedures for

equipment and physical environment space were updated

and reinforced.

Data reviews also became part of the operational canvas.

These helped leaders and other stakeholders identify high

risk patients and create better decision trees to prevent or

mitigate risks associated with these infection subgroups. Fi-

nally, treatment protocols such as isolation were leveraged as

appropriate.

Similarly, the team implemented several tactics to combat

CAUTI. For example, protocols were updated, standard-

ized, cascaded to stakeholders and reviewed periodically to

ensure effectiveness of care and services. Also, upskilling was

a major part of the improvement prescription. Techniques

such as utilizing skills days, orientation, competencies and

other training for clinicians were successful. With enhanced

knowledge, care was better.

Also, the team leveraged an evidence-based decision ap-

proach. Here, leaders established goals, measured data and

included this insight into regular report-outs to teams, lead-

ers and other stakeholders. The key was situational aware-

ness. The goal was to ensure that stakeholders knew when

action was needed versus when it was not.

New techniques were also injected into the improvement

equation. For example, a new noninvasive device was used,

when applicable. The team learned that limiting the occur-

rences of introducing a foreign body (i.e., catheter) into the

patients helped reduce infection rates.

After implementing these tactics, periodic reviews were

conducted to measure the effectiveness of all solutions. If

they were found to be effective, the team continued full

steam ahead. If solutions proved to add no value, the team

would pivot until the optimal improvement was identiﬁed.

This ties directly back to evidence-based decision-making,

relationship management and continuous improvement in

ISO 9001:2015 methodology.

Measuring outcomes

The team realized signiﬁcant improvement outcomes as it

relates to both infection groups. For both C. diff and CAU-

TI infections, the team studied progress over approximately

a 10-year period. The data set included monthly infection

counts per subgroup from 2013 to 2022. As noted, the hos-

pital became ISO 9001:2015 certiﬁed in 2017. Thus, several

years of data before and after certiﬁcation was included in

the review.

The team realized a 50% reduction on average in C. diff

infections (see Figure 1 for details). The null hypothesis

states there was no change. The alternative hypothesis states

that C. diff rates were reduced post ISO 9001:2015 certiﬁca-

tion. Test of hypothesis (paired comparison large sample size)

FIGURE 1

C.diff count

The team realized a 50% reduction on average in C. diff infections.

September 2022 | ISE Magazine 43

was utilized to test the theory. In short, the 50% reduction

in C. diff infections was signiﬁcant at the 99% conﬁdence

level as Z test (6.75) was greater than 1 Tail Z Table (2.32).

Thus, infections improved post-ISO 9001:2015 certiﬁcation

at this facility.

The hospital also realized a 16% reduction in C. diff stan-

dard deviation (Figure 2). The takeaway is that both the

number of infections and the variation in these outcomes

were signiﬁcantly improved post-ISO 9001:2015 certiﬁca-

tion.

Next, the team tested the CAUTI outcomes. As noted in

Figure 3, there was a 53% reduction in CAUTI infections

following ISO 9001:2015 certiﬁcation. The null hypothesis

states there was no change. The alternative hypothesis states

that CAUTI infections declined. Test of hypothesis (paired

comparison large sample size) was used to test the theory. In

short, the 53% reduction in CAUTI infections was signiﬁ-

cant at the 99% conﬁdence level as Z test (3.19) was greater

than 1 Tail Z Table (2.32). Thus, infections improved post-

ISO 9001:2015 certiﬁcation at this facility.

FIGURE 2

C.diff box plot

The hospital realized a 16% reduction in C. diff standard deviation after ISO 9001:2015 certiﬁcation.

FIGURE 3

CAUTI count

The team found a 53% reduction in CAUTI infections post-certiﬁcation.

44 ISE Magazine | www.iise.org/ISEmagazine

Leveraging improvement efforts to reduce hospital infections

As with C. diff variation, the facility realized a 50% re-

duction in CAUTI standard variation (see Figure 4). The

takeaway is that both the number of CAUTI and the varia-

tion in these outcomes were signiﬁcantly improved post-ISO

9001:2015 certiﬁcation.

Lessons learned

In retrospect, there are several lessons the team learned

along the journey. One, leaders and their organizations don’t

know what they don’t know. Ignorance is never bliss. The

key is measurement. The old adage of “measure twice and

cut once” applies here. What leaders don’t measure and sub-

sequently don’t know will eventually unfavorably impact

them, their organizations and the customer.

Two, all good improvement starts with a methodology.

Regardless of their ﬂavor, Lean, Six Sigma or ISO 9001:2015

really work if the basics are in place. Success depends upon

top leadership sponsorship, evidence-based decision-mak-

ing, organizational knowledge and a clear vision for what

success really is. If the key attributes are in place, the meth-

odology will succeed.

Three, organizations must deﬁne the customer and un-

derstand what value means to each one. The customer or

stakeholder list should be exhaustive and span beyond the

traditional view of “patient,” as in the healthcare example.

Once primary and secondary customers are identiﬁed,

change agents should ensure these attributes are represented,

measured, tracked and improved so value is enhanced to all

customers.

In summary, improvement methodology should not be

limited to only hard dollar savings. Improvements tied to

direct customer outcomes in service and quality are equally

if not more important in certain scenarios. Also, methodolo-

gies such as Lean, Six Sigma or ISO 9001:2015 can and do

save lives if leveraged properly. The key is having change

aligned with organizational culture and customer require-

ments.

Moreover, improvement can be a reality, not just a pipe

dream with the right structure, process and people focus.

Finally, change agents can realize long-term improvement

wins that stand the test of time even in the face of a pan-

demic.

The takeaway is that insight, knowledge and methodology

are impactful. Effective leaders are those who understand the

customer, leverage evidence to make life-saving decisions,

measure and mitigate risk and sustain wins long term.

Authors’ note: The team would like to give a special thanks to

Quality, Accreditation, Lab, leadership and the staff that relentlessly

provide great care and services to tens of thousands of patients each

year. This is a testament to the team’s commitment to providing the

safest, highest quality of care possible. 

Sonya Floyd RN, BSN, CIC, is Infection Prevention Control and

Epidemiology System Manager for Atrium Health Navicent.

Casey Bedgood, MPA, CSSBB, is a Six Sigma Black Belt (IISE)

and System Accreditation Optimization Ofﬁcer for Atrium Health

Navicent. He is an IISE member.

FIGURE 4

CAUTI box plot

As with C. diff variation, the facility realized a 50% reduction in CAUTI standard variation.