AJCP / REVIEW ARTICLE
Getting It Right for Patient Safety
Specimen Collection Process Improvement From
Operating Room to Pathology
Rita D’Angelo, MS, and Olugbenga Mejabi, PhD
From the School of Industrial and Systems Engineering, Wayne State University, Detroit, MI.
Key Words: Management; Administration; Histology; Generalist
Am J Clin Pathol July 2016;146:8-17
DOI: 10.1093/AJCP/AQW057
ABSTRACT
Objectives: Specimen labeling defects within the periopera-
tive environment are a known patient safety risk that carries
the potential for adverse outcomes. These outcomes are a
result of errors that occur when unsuspecting providers
operate within poorly designed processes with little control
over the specimen collection context. Many costly outcomes
resulting from labeling errors may include patient harm,
inappropriate treatments, lengthy investigations, corrective
actions, and, at times, legal action.
Methods: This improvement initiative to identify and reduce
the risk of specimen labeling defects includes the applica-
tion of a disciplined Lean problem-solving approach with
the engagement of employees who actually perform the
work.
Results: By listening to the voice of our internal customers,
we collectively redesigned the workflow by collaboratively
linking work teams of the operating room and Pathology
Department of Henry Ford Hospital, Detroit, over a 2-year
period.
Conclusions: We illustrate successful interventions
achieved by Lean process management by streamlining,
standardizing, and mistake proofing the processes and
eliminating waste and inefficiency through systematic
problem solving.
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All patients expect that the results of their diagnostic
tests should indeed be their own and do not belong to an-
other patient. In health care today, these uncertainties are
valid concerns reflected in a national patient safety goal for
accurate patient identification both for diagnostic testing as
well as treatment. This extends from patient identification
to accurate specimen tracking and significantly affects error
rates inherent in current health care processes.
Specimen labeling defects in the perioperative environ-
ment are a known safety risk for sometimes serious adverse
patient outcomes and unnecessary costs from both rework
of investigations and corrective actions. It is estimated that
17% of specimen misidentification defects result in incor-
rect therapies, and almost 6% result in adverse events.1,2
Bixenstine et al3 noted that the “correction of such identifi-
cation defects consumes valuable resources; each may take
an average of 3.5 hours to correct.”
Although the frequency of these defects may not be
very high, they are not insignificant. In the largest compre-
hensive voluntary study of 1 million outpatient and inpatient
specimens from 417 hospitals in 1998, specimen container
and requisition labeling defects occurred in 6% of cases or
60 of 1,000.4 In a more focused study in 2007 of the
operating room (OR) specimen identification process at
Johns Hopkins Medical Center, Makary et al5 documented
specimen labeling deficiencies with inaccuracies such as ab-
sence of patient name, omission of details regarding tissue
site, or inaccurate details to be 3.7 per 1,000 specimens.
Health care is faced with many challenges, and that in-
cludes current barriers that inhibit our ability to effectively
design and provide safe, reliable, cost-effective, quality care
© American Society for Clinical Pathology, 2016. All rights reserved.
For permissions, please e-mail: journals.permissions@oup.com

to the patient. The Institute of Medicine addressed this chal-
lenge prominently in 2011, describing the need to transform
poorly designed processes in health care as “the gap be-
tween where health care is and where it needs to be.”6 There
have already been numerous attempts to correct process de-
fect issues within OR and pathology departments.4 This art-
icle presents a method that enabled this implementation to
be successful where others lacked sustainability.
Description of the Problem
In 2009, we initially began the project to examine mis-
labeled specimens for the Statewide Keystone-Surgery
Patient Safety Initiative of the Michigan Hospital
Association.3,7 This collaborative of 85 hospitals voluntarily
participated in a 3-month pilot of OR specimen labeling ac-
curacy with an overall specimen defect rate of 2.9% or 29 of
1,000.3 These are poor levels of quality, equating to 3
sigma, with a significant potential to affect patient safety.
This raised awareness of our own internal process flaws at
Henry Ford Hospital.
Rationale for Improvement
The focus of the study at Henry Ford Hospital was to
assess the presence/absence of seven specific required spe-
cimen requisition and container information elements such
as misidentification, lack of required data, and incorrect lat-
erality. In addition to the statistical analysis aligned with the
Keystone initiative, we saw significant opportunities for
data capture that fell outside of the specific project require-
ments. These data sets were tallied and included as the
“other” category that later proved to be a rich data source
for process improvements.
The Setting
The endeavor to redesign safer processes for specimen
collection and delivery began with a multidisciplinary team
initiative from the OR and then moved to the pathology
department over a 2-year period (2010-2012). The 802-bed
inner-city tertiary care hospital includes surgical teams
operating within specialties of expertise across 31 ORs.
Most important, for this quality improvement initiative, the
process variation within these surgical teams was further
complicated by lack of standards for specimen collection
and processing. The variations within the surgical processes
required a collaborative effort to coordinate standardization
across 31 ORs. This effort enlisted the representation of
© American Society for Clinical Pathology
9 DOI: 10.1093/ajcp/aqw057
AJCP / REVIEW ARTICLE
nurses, surgeons, pathologists, technologists, technicians,
and managers, as empowered employees who took owner-
ship for the redesign of the processes.
Materials and Methods
The methods described within this quality improvement
initiative were based on a “step-by-step” approach for Lean
continuous improvement through data collection, observation
techniques, and customer-supplier interaction. The method
for initial data collection included the focus on 14 specific
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defects associated with testing orders (requisition) and asso-
ciated specimen containers. We also analyzed the improve-
ment opportunities that were identified as a result of the
“other” category of data collection. We then used these data
collection results as an impetus for redesign and standardiza-
tion of processes between the two departments, OR and
Pathology. The effort focused on areas that exhibited a lack
of efficient, standardized handoffs and direct connections.
The following paragraphs describe improvements imple-
mented as a result of the process standardization.
Data Collection
The initial data collection plan was developed to iden-
tify and document the current state of specimen defects
within the laboratory. The average number of specimen con-
tainers received within the laboratory was 800 per month,
with 700 specimen testing orders formally known as requisi-
tions. Defects were documented by a pathologist’s assistant
in the laboratory at the point of specimen receipt. An elec-
tronic form with built-in logic was used to enter data for
each requisition, specimen, and subpart Figure 1 .
All “other” defects were identified, analyzed, and tabu-
lated for root cause analysis in addition to the mandated
elements. The “other” designations, unrelated to an existing
category, carried the potential and opportunity for further
improvement and were categorized as inefficiencies or lack
of process integrity.
The defects categorized within the “other” category are
shown in Table 1 .
Using the Lean Approach
Our approach for process improvement with OR services
was based on the Lean method. This application of Lean prob-
lem solving and continuous improvement was adapted from
manufacturing as implemented in systems such as the Ford
Production System and the Toyota Production System.8-11
Am J Clin Pathol 2016;146:8-17 9
D’Angelo and Mejabi / GETTING IT RIGHT FOR PATIENT SAFETY
25
20
15
10
0
Jan Feb Mar Apr May June July Aug Sep Oct Nov Dec Jan Feb Feb Mar Apr May June July Aug
2010 2010 2010 2010 201 2010 2010 2010 2010 2010 2010 2010 2011 2011 2011 2011 2011 2011 2011 2011 2011
Figure 1 The number of specimen and requisitions defects per month for January 2010 through August 2011.
The Lean Enterprise Institute12 describes Lean as a system for
“maximizing customer value while minimizing waste to cre-
ate more value for customers and using fewer resources.” It is
estimated that more than 90% of Lean efforts fall short of ex-
pectations. This is due to a method that is superficial with re-
gard to culture change.13 This project therefore aimed to focus
on a Lean approach based on strong leadership collaboration
to introduce a philosophy, structure, processes, and incentives
that enabled the teams to work together to design and imple-
ment solutions. Our clinical colleagues, although not previ-
ously educated in the significance of waste reduction through
Lean, were included in an adaptation of this approach with
just-in-time training as the project progressed. Our core meth-
od was based on Plan, Do, Check, Act (PDCA) or scientific
data-driven hypothesis and test problem solving. We also em-
ployed direct observation, process flow and value stream map-
ping (a high-level view of the entire process to identify
opportunities for improvement and redesign a more efficient
process), work redesign, error and mistake proofing (a process
designed to avoid human error), customer-supplier integration
between separate work groups, and employee engagement in
process improvements based on “go and see” (it is necessary
to observe the process and deeply understand the root cause to
understand the significance of the problem). We labeled the
identified issues as in-process defects to classify all nonstan-
dard and unexpected work outcomes that caused any em-
ployee to stop, fix, or delay the work; work returned to
sender; or where internal customers just were not satisfied,
indicating that the work could have been done better.
Cross-Functional Teams: “Customer-Supplier”
Meetings
To address in-process defects and opportunities for im-
provement, weekly customer-supplier meetings consisting
of nurses, residents, surgeons, pathologist assistants, the
10 Am J Clin Pathol 2016;146:8-17
10 DOI: 10.1093/ajcp/aqw057
Specimen
Requisition
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Table 1
Process Defects Identified Within the “Other Category”
Defects within pathology
Lack of laboratory standard process in laboratory
Lack of laboratory employee competency and training in
laboratory
Quality control check not performed—container: requisition
verification
Defects along the value stream
Lack of communication/process between operating room (OR)
and pathology
Matching specimen parts/requisitions
Lack of chain of custody upon specimen drop-off
Defects originating within the OR
Number of specimens did not match the requisition
Incorrect information documented on the requisition
Patient identification not on all specimen parts
Missing complete clinical history
Most requisitions missing the time of procedure
Failure to establish and/or follow a standard process
Poor communication or poor handoffs
Human error
Staffing not matching workload
No rotation of staff duties to eliminate fatigue
Failure to educate and assess competency
quality manager, and nurse managers were initiated between
the OR and pathology Table 2 . The specimen labeling con-
cerns with the potential to affect patient safety were priori-
tized and discussed at each weekly meeting.
Observation Sessions
The Lean principle of “go and see” was critical for iden-
tifying defects, wastes, and redundancies within processes
involved in collection and processing of specimens. Each
member of the team was instructed to physically follow one
specimen through the specimen collection process from the
OR to the pathology department to better understand how de-
fects originated within the handoff process. The team docu-
mented their findings and photographed pertinent events that
were later reviewed and used as the impetus for improvement.
© American Society for Clinical Pathology

Table 2
Defects Noted by Nurses
Specimen read-back was not always performed result:
inaccurate patient/specimen information
Nurses could not always spell the specimen part types
Nurses afraid to ask for the correct spelling of part types
The transport bag used to deliver specimens was problematic
(green and not transparent)
Nurses kept a redundant personal running list of specimens taken
and delivered to the laboratory
The exact information was redundant and duplicated at the
laboratory specimen drop-off
Observation Within the OR
In addition to defects captured with the data collection
tool, the “other” category, illustrating unclassified process
inefficiencies, waste, and variation, became quite signifi-
cant. Although well-intentioned, employees innocently con-
tributed to in-process variation as a result of informal
training inherited from their former colleagues throughout
the years. It became apparent that tasks relating to specimen
collection, delivery, and processing included significant
variation, and one standard across-the-board approach was
necessary. On the basis of observation, we identified numer-
ous redundancies within the manual processes. In fact,
many nurses developed their own personal work-around in
the form of handwritten notes that they carried in their pock-
ets Figure 2 and Table 3 .
Their intent was to defensively record specimens for
which they were personally responsible for transporting to
Pathology. This was a form of “cover your tail” rather than a
standard work expectation, illustrating the fact that there was
little confidence or trust in a poorly defined system of work.
By observation, it was determined that the specimen
collection process included a total of nine steps to collect,
document, label, and deliver each specimen to the labora-
tory. This process is depicted in Table 4 and Figure 3 .
Specimen Read-Back Procedure Within the
ORs
Although the OR had adopted the World Health
Organization (WHO) guideline for a perioperative read-
back procedure between the surgeon and OR staff, there
was lack of any standard regarding how the patient/speci-
men information was to be communicated as part of the spe-
cimen handoff process. To verify information, the WHO
recommends the circulator to perform read-back with the
surgeon to confirm that all specimens were labeled cor-
rectly.7 Because of the lack of a standard, the nurses had
some difficulty in performing the read-back procedure with
the surgeons. To establish a standard, we enlisted the
© American Society for Clinical Pathology
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AJCP / REVIEW ARTICLE
Figure 2 The circulator nurses kept a personal, handwritten
redundant copy of specimens collected and delivered to the
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laboratory. This was a nonstandard quality control check.
Table 3
Defects Identified Within the Operating Room (OR)
Multiple sites to document—redundancy within documentation
Identical information was documented in multiple places within the
OR
Information was documented a second time in pathology
The transport bag used to deliver specimens was green and not
transparent
Nurses maintained a redundant personal running list of specimens
The exact information was duplicated again at the laboratory
specimen drop-off point
involvement of the chair of Surgery to align and educate
surgeons on the importance of the read-back procedure. The
specimen read-back education was provided to surgeons
through video segments played through the closed-circuit
OR television to be viewed while the surgeon scrubbed. The
improved instruction for surgeons now integrated processes,
people, and procedures to achieve one standardized read-
back message that emphasized the surgeon’s role in patient
and specimen safety based on a surgeon speaking to his or
her surgical peers. Additional instructional videos were de-
veloped for OR staff to communicate requirements and to
solidify the standardized read-back process during specimen
collection. The specimen handoff and read-back procedure
standardized in the OR was captured in video and used ini-
tially to train 200 OR staff. The video was later developed
into an educational module, as an annual refresher for exist-
ing staff as well as training for new staff.
Implementation of Labels to Identify Special
Handling
One of the identified key root causes of defects were spe-
cimens that required special handling but contained no spe-
cific instructions. We addressed the top five most common
tissue sample processes or work streams containing critical
defects: (1) specimens for routine pathologic examination,
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Table 4
Steps of a Surgical Nurse
1. Check patient file for correct order of anatomic site/procedure
2. Complete laboratory requisition
3. Enter specimen information in Surgical Information System
4. Write specimen description on the containers
5. Write specimen description on the container labels
6. Write specimen description on the laboratory requisition
7. Keep adding a running tab (notepad) of all of the above
specimens
8. Write identical information (specimen description) on the logbook
9. Multiple frozen-section specimens are delivered at different times
10. Create multiple laboratory requisitions if the original has run out
of space
11. Photocopy the requisition in lieu of writing multiple times in the

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logbook (the photocopy machine not located nearby)

(2) frozen-section specimens, (3) specimens for lymphoma

workup, (4) open lung biopsy protocol specimens, and (5)
tissue specimens for microbiologic examination Figure 4 .
To identify unique laboratory testing, a color-coded
specimen label was developed that contained processing in-
formation associated with each work stream. The special
handling requirement was front-loaded for each specimen
stream and used as a standard and to ensure mistake-proof
processing. “Label Stations” were developed and installed
in each of the ORs. Each “Label Station” contained rolls of
color-coded labels for use by the circulator nurse to immedi-
ately label the specimen containers and file requisitions, as
well as expedite processing.

Approach to Implementation: One Standard

Process
On the basis of the noted nonstandard processes whose
variation contributed to the documented defects, the team
was instructed to adopt one standard pathway to collect,
label, and deliver specimens to the laboratory. This process
redesign would serve as a standardized process within the
OR in the absence of an electronic specimen tracking sys-
tem and in preparation for the new information system.
The teams performed the following sequence of events:
• Review the results of multiple observations and identify
commonalities of waste, including non-value-added
steps, process variation, and redundancy
• Identify opportunities for improvement
• Create the future state by standardizing the value-added
steps
• Implement and monitor the perfected process for Figure 3 The specimen collection process includes a num-
effectiveness ber of redundancies and wastes. Each picture represents
• Educate super-users, who will then train all staff on the one of nine steps in the process.
new processes
• Adjust the process based on user feedback

12 Am J Clin Pathol 2016;146:8-17 © American Society for Clinical Pathology

12 DOI: 10.1093/ajcp/aqw057

Figure 4 Idea borrowed from Sparrow Hospital in Michigan: specimen labels illustrating specimen-handling instructions.
Figure 5 Piggyback label packet that includes three impressible copies.
Process Redesign: Development of a
Piggyback Label Process
On the basis of the significant variation, redundancy in
documentation, and feedback from nurses, the teams developed
one standardized specimen collection process. This process
included the concept of using a single multipart label packet
with multiple copies Figure 5 . The form was tested and itera-
tively modified through numerous PDCA cycles until all users
were satisfied with the new tool. This three-part label packet
contained label information intended for the requisition and
transferred this information through to the container copy and a
final reconciliation page. The reconciliation copy was designed
© American Society for Clinical Pathology
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AJCP / REVIEW ARTICLE
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for OR staff to confirm that all specimens were accounted for
and were correct. This reconciliation page eliminated the need
for the personal running list that had previously been tabulated
by many nurses. The surgeon or his or her designee provided
the final approval required on the label.
The specimen requisition was also revised to include
placeholders for chronological label placement Figure 6 .
The Piggyback Labeling Pilot
A pilot to test the piggyback label packet was con-
ducted in partnership with the four gynecology-oncology
(GYN-ONC) surgeons of Women’s Health Services who
Am J Clin Pathol 2016;146:8-17 13
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D’Angelo and Mejabi / GETTING IT RIGHT FOR PATIENT SAFETY
Figure 6 A revised requisition for piggyback label placement.
performed their procedures within the OR. Since the sur-
geons had been previously Lean trained as part of the Lean
management culture development program, it was ideal that
they should serve as champions for the pilot to guide the ul-
timate success of the project.
Surgeon-Driven Standard Work
To further assist the nurses and to standardize the designation
of the specimen part type names and surgical procedures, the
GYN-ONC surgeons reviewed and, by consensus, revised and
developed a master terminology list Table 5 . This list was
adopted for use as a surgeon-nurse communication tool used
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within the GYN-ONC operating rooms and served as a standar-
dized and consistent identification method for specimens sub-
mitted for specific tests to be performed by pathology.
This standardization by the surgeons allowed the surgi-
cal team to reliably and accurately comply with the WHO’s
guidelines for safe surgery requiring verbal confirmation of
the correct patients and their specimen information.7
Data Analysis and Results
Table 6 lists implemented improvements and significant
changes that resulted from this quality improvement initiative.
© American Society for Clinical Pathology
 AJCP / REVIEW ARTICLE

Table 5
Development of an Obstetrics/Gynecology Standardized Part Type List to Ensure a Defect-Free Specimen Handoff
CPT Description Specimen/Part Type Name Specimen/Part Type Description
Fallopian tube sterilization Fallopian tube sterilization, left Left, fallopian tube, partial salpingectomy
Fallopian tube sterilization Fallopian tube sterilization, right Right, fallopian tube, partial salpingectomy
Fallopian tube tumor Fallopian tube, tumor þ ipsilateral, ovary, left Left, fallopian tube and ovary, excision
Fallopian tube tumor Fallopian tube, tumor þ ipsilateral, ovary, right Right, fallopian tube and ovary, excision
Fallopian tube tumor Fallopian tube tumor, left Left, fallopian tube, salpingectomy
Fallopian tube tumor Fallopian tube tumor, right Right, fallopian tube, salpingectomy
Salpingectomy, complete or Fallopian tubes, bilateral, salpingectomy Fallopian tubes, bilateral salpingectomy
partial, unilateral or bilateral
CPT, Current Procedural Terminology, American Medical Association.

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Table 6
Results and Significant Quality Improvements
Result Pre Post Percent Reduction
1. Global defect rate, % 89 25 74
2. Surgical specimen collection steps, No. 9 3 67
3. Redundant documentation, No. Numerous 1 99
Quality improvements
4. Formation of customer supplier meetings
5. Color-coded labels for specimen handling
6. Color-coded label stations
7. Surgeon video training—importance of read-back
8. Operating room staff video training—importance of read-back
9. Development of piggyback specimen labels
10. Obstetrics/gynecology specimen procedure list
11. Surgeons—empowered as Lean champions

Impacts of Results Discussion

Numerous impacts were identified as a result of the en- To our knowledge, there is no comprehensive literature
tire process improvement efforts; these are summarized demonstrating how health care institutions have success-
below. fully dealt with the universal potential patient safety prob-
The application of the Lean method yielded several lem in the OR–pathology department process, using Lean
benefits: methods. As noted by Simon et al,14 finding publications
• Process simplification that discuss Lean theories and tools within the literature is
• Removal of waste and inefficiency plentiful; however, few publications actually describe how
• Increased employee satisfaction to apply the tools and at what phase of the process reforma-
• Standardized processes and development of standard tion. In our study, we attribute the significant accomplish-
work ment of a sustained reduction in specimen labeling defects
• Increased surgeon involvement to the collaborative Lean system redesign by OR and
• Improved communication through multidisciplinary Pathology work group owners committed to finding com-
teams working toward common goals mon ground in redesigning their work to make a difference
The Lean principles that were applied, as foundations, for patient safety.
for achieving these results included the following: The number of defective processes at the onset of the
• Color coding (visual controls) initiative was frustrating for those who were held account-
• Customer-supplier integration able for the outcomes but had very little control or input
• Process and value stream mapping into improving the process. As a raw number, the actual
• Process restructuring to incorporate pull, process flow, number of defects seemed to be quite few, and this made
and load leveling creating a “burning platform” case for change very
• Worker empowerment within cross-functional teams challenging.

© American Society for Clinical Pathology Am J Clin Pathol 2016;146:8-17 15

15 DOI: 10.1093/ajcp/aqw057
D’Angelo and Mejabi / GETTING IT RIGHT FOR PATIENT SAFETY
The most profound challenges when implementing these
Lean initiatives were those of garnering support and navigat-
ing through the silos of control to improve the existing out-
worn legacy processes. In addition, efforts of this nature
required leaders to prioritize, manage, and dedicate resources
to issues that were historically considered “pathology’s prob-
lem.” Regardless of the originating department, in our experi-
ence, the most effective leaders for change exhibited
perseverance, passion, and dedication despite inevitable set-
backs and frustrations inherent in the team approach.
Another significant challenge to change in any OR set-
ting is the lack of surgeon involvement. Few surgeons had
the time or interest to assist with new process design efforts,
but their participation was invaluable once recruited on the
team. The success of some of these initiatives was directly
related to the involvement of the chair of women’s health
services, who directed the piggyback label pilot, and the
chair of surgery, who was instrumental in developing the
read-back training video for surgeons.
The complex processes we encountered that were once
fraught with waste and inefficiency were tackled by the con-
sistent application of one process improvement resolution at
a time over a 2-year period. The observation sessions or “go
and see” were instrumental to placing the observer em-
ployee directly within the dysfunctional OR process as “one
of the team” to identify wasteful steps firsthand. We found
that the OR teams were shocked to learn of their wasteful
non–value-added work steps, but they were also pleased to
collaboratively eliminate several redundant steps involved
in collecting, labeling, and delivering a specimen. This re-
sulted in significant time savings for the OR employees and
gave them more confidence in the reliability and consist-
ency of their new system of work. The creation of the piggy-
back label packet and process also resulted in significant
reductions in handwritten documentation and increased accur-
acy of specimen collection by forcing a standardized “collect
one, label one at the bedside” process. The nurses’ handwritten
personal lists and tallies of specimens delivered to the labora-
tory were no longer required as a defense since the responsible
nurse now had a specimen reconciliation page for each patient
as he or she filled out the multipart piggyback label packet in
real time. The creation of a standardized specimen job-aid
by the surgeons, listing all common procedures with
the associated specimen part types, was also beneficial to the
OR staff responsible for accurate specimen documentation.
Conclusions
The three most important lessons that have been
learned here in achieving a sustained reduction in specimen
labeling defects are the following:
16 Am J Clin Pathol 2016;146:8-17
16 DOI: 10.1093/ajcp/aqw057
• Change requires leadership support and cross-functional
team involvement to effectively improve across bounda-
ries of control.
• Every process redesign requires the involvement of those
who actually do the work; these are the people who
understand the nitty-gritty details of exactly how the de-
fects arise and are often “expert” in suggesting how suc-
cessful changes can be made.
• Focused changes require not one but numerous PDCA
cycles with identification of root causes and counter-
measures that must be consistently and carefully identi-
fied and sustained.
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Our baseline specimen defect rate of 2.25% corres-
ponds closely to the overall rate of 2.9% of surgical cases
lacking the correct patient/specimen information (specimen
requisitions and containers) that was documented in the
pilot of the 2009 Michigan Keystone-Surgery collaborative
pilot study, which used a similar but slightly less compre-
hensive data collection tool compared with the one that we
used here, which included an additional “other” defects cat-
egory.3 From May 2010 to March 2012, the surgical speci-
men defect rate for hospitals participating in the Michigan
statewide collaborative decreased 30%, from 2.64% to
1.85% or 18.5 per 1,000.15 By comparison, our specimen
defect rate over this same timeframe was reduced by 89% to
0.25% or 2.5 per 1,000 cases. We have shown here that the
power of embracing a culture of continuous improvement
results from leveraging innovations that come best from
those directly involved in performing the work. We believe
that employee empowerment in a continuous improvement
culture is the foundation of Toyota’s historical Lean suc-
cesses, and this applies just as well to other work cultures
outside of manufacturing. It is certainly now time for health
care leaders to embrace the Institute of Medicine’s call for
“continuous improvement—incorporating innovation, disci-
plined quality improvement, and evaluation . . . [to] meet
the goals of optimizing patient experience and outcomes,
improving the health of the population, and controlling
cost.”6
Corresponding author: Rita D’Angelo, MS, 30033 Pointe Dr,
Rockwood, MI 48173; Dangeloadvantage@gmail.com.
Acknowledgments: The authors gratefully acknowledge the sig-
nificant contributions of the following Henry Ford Hospital lead-
ers to these team successes: Adnan Munkarah, MD, Chair of
Women’s Health Services, and his surgical team for leading the
pilot; Scott Dulchavsky, MD, Chair of Surgery; Craig Reickert,
MD, Division Head of Colorectal Surgery; OR services team lead-
ers Barbara Gagnior, Brian Watha, and Jackie Adams; and the
many OR team members. We are grateful to the pathologist assist-
ant team leader Nelson Main and the numerous members of
Pathology and Laboratory Medicine, especially Ruan Varney and
Susan Rudiger, who contributed countless hours, innovative ideas,
© American Society for Clinical Pathology

and leadership support that were vital to these many successes.
A special acknowledgment goes to Richard Zarbo, DMD, Chair
of Pathology and Laboratory Medicine, for his relentless dedica-
tion for enhancing quality in health care and supporting patient
safety.
References
1. Valenstein PN, Raab SS, Walsh MK. Identification errors
involving clinical laboratories: a College of American
Pathologists Q-Probes study of patient and specimen identifi-
cation errors at 120 institutions. Arch Pathol Lab Med.
2006;130:1106-1113.
2. Layfield LJ, Anderson GM. Specimen labeling errors in surgi-
cal pathology: an 18-month experience. Am J Clin Pathol.
2010;134:466-470.
3. Bixenstine PJ, Zarbo RJ, Holzmueller CG, et al. Developing
and pilot testing practical measures of preanalytic surgical
specimen identification defects. Am J Med Qual.
2013;28:308-314.
4. Nakhleh RE, Zarbo RJ. Amended reports in surgical path-
ology and implications for diagnostic error detection and
avoidance: a College of American Pathologists Q-Probes
study of 1 667 547 accessioned cases in 359 laboratories. Arch
Pathol Lab Med. 1998;122:303-309.
5. Makary MA, Epstein J, Pronovost PJ, et al. Surgical specimen
identification errors: a new measure of quality in surgical
care. Surgery. 2007;141:450-455.
© American Society for Clinical Pathology
17
AJCP / REVIEW ARTICLE
6. Selker H, Grossmann C, Adams A, et al. The Common Rule and
Continuous Improvement in Health Care: A Learning Health System
Perspective. Washington, DC: Institute of Medicine; 2011.
7. World Health Organization (WHO). WHO Guidelines for
Safe Surgery, 2009: Safe Surgery Saves Lives. Geneva,
Switzerland: WHO; 2009. http://apps.who.int/iris/handle/
10665/44185. Accessed August 13, 2014.
8. Zarbo R, D’Angelo R. Transforming to a quality culture: the
Henry Ford Production System. Am J Clin Pathol.
2006;126(suppl 1):S21-S29.
9. D’Angelo R, Zarbo R. The Henry Ford Production System:
measures of process defects and waste in surgical pathology as
a basis for quality improvement initiatives. Am J Clin Pathol.
2007;128:423-429.
Downloaded from https://academic.oup.com/ajcp/article-abstract/146/1/8/1730325 by guest on 06 July 2020
10. Zarbo RJ, D’Angelo R. The Henry Ford Production System:
effective reduction of process defects and waste in surgical
pathology. Am J Clin Pathol. 2007;128:1015-1022.
11. Zarbo RJ. Creating and sustaining a Lean culture of continuous
process improvement. Am J Clin Pathol. 2012;138:321-326.
12. Lean Enterprise Institute. What is Lean? http://www.lean.
org/WhatsLean/. Accessed May 22, 2015.
13. Ballé M, Ballé F. The Lean Manager: A Novel of Lean
Transformation. Cambridge, MA: Lean Enterprise Institute; 2009.
14. Simon R, Elena G, Canacari E. A practical guide to applying
lean tools and management principles to health care im-
provement projects. AORN J. 2012;95:85-103.
15. Michigan Hospital Association, MHS Keystone Center.
http://www.mhakeystonecenter.org/surgery.htm. Accessed
August 13, 2014.
Am J Clin Pathol 2016;146:8-17 17
DOI: 10.1093/ajcp/aqw057