Anatomic Pathology / Gross Room Quality Improvement

The Effect of a Lean Quality Improvement Implementation

Program on Surgical Pathology Specimen Accessioning
and Gross Preparation Error Frequency
Maxwell L. Smith, MD,1 Trent Wilkerson,1 Dana M. Grzybicki, MD,2 and Stephen S. Raab, MD1

Key Words: Quality improvement; Near-miss; Lean; Gross examination room; Active errors; Latent errors

DOI: 10.1309/AJCP3YXID2UHZPHT

CME/SAM
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Upon completion of this activity you will be able to: The ASCP is accredited by the Accreditation Council for Continuing
• discuss the difference between active (operator-dependent) and latent Medical Education to provide continuing medical education for physicians.
(process-dependent) near-miss events and errors and identify them in The ASCP designates this journal-based CME activity for a maximum of 1
the processing areas of the laboratory. AMA PRA Category 1 Credit ™ per article. Physicians should claim only the
• compare and contrast pull-based continuous flow systems with push- credit commensurate with the extent of their participation in the activity.
based batched systems. This activity qualifies as an American Board of Pathology Maintenance of
• describe components of successful implementation plans. Certification Part II Self-Assessment Module.
The authors of this article and the planning committee members and staff
have no relevant financial relationships with commercial interests to disclose.
Questions appear on p 478. Exam is located at www.ascp.org/ajcpcme.

Abstract The safety pyramid was developed in 1931 by Heinrich1

Few reports have documented the effectiveness to highlight the relationship between frequency of error and
of Lean quality improvement in changing anatomic degree of patient harm. In this model, a large number of errors
pathology patient safety. We used Lean methods of occur at the broad base of the pyramid that do not result in
education; hoshin kanri goal setting and culture harm. As the pyramid narrows toward the peak, the number of
change; kaizen events; observation of work activities, errors decreases but the degree of harm increases. In complex
hand-offs, and pathways; A3-problem solving, metric systems, multiple process errors may share root causes. There-
development, and measurement; and frontline work fore, the study and elimination of frequent errors that may not
redesign in the accessioning and gross examination cause direct harm have the potential to indirectly decrease
areas of an anatomic pathology laboratory. We both overall error rates and harm. The Institute of Medicine
compared the pre- and post-Lean implementation report in 1991 estimated the financial and humanitarian cost of
proportion of near-miss events and changes made in preventable medical errors at between 17 and 29 billion dollars
specific work processes. In the implementation phase, and between 44,000 and 98,000 hospital deaths.2
we documented 29 individual A3-root cause analyses. As a first step in the process of error reduction, errors
The pre- and postimplementation proportions of must be identified and classified. The most common clas-
process- and operator-dependent near-miss events were sification systems are often based on clinical impact. Sentinel
5.5 and 1.8 (P < .002) and 0.6 and 0.6, respectively. events are errors that reach the patient and are associated with
We conclude that through culture change and significant patient harm. No-harm events are errors that reach
implementation of specific work process changes, Lean the patient but do not result in patient harm. Near-miss events
implementation may improve pathology patient safety. are incidents, actions, and processes that are expected to result
in significant patient harm if they are not corrected before they
reach the patient. An example of a near-miss event is a speci-
men identification mismatch in the technical processing area
of a pathology laboratory that results in a malignant diagnosis
being rendered on the wrong patient specimen and entered
into the laboratory information system. If, before releasing
the report, the pathologist recognizes the error and corrects
the report in the system, the original specimen identification
mismatch is a near-miss event. Near-miss events have been
classified as process-dependent (events occurring as part of the
normal workflow) and operator-dependent (events associated

© American Society for Clinical Pathology Am J Clin Pathol 2012;138:367-373 367

367 DOI: 10.1309/AJCP3YXID2UHZPHT 367
Smith et al / Gross Room Quality Improvement

with staff activities outside the standard workflow).3 Near-miss specimens annually. For this study, we evaluated the post-
events make up the bulk of Heinrich’s safety pyramid base. implementation near-miss error proportion in the specimen
After the identification of errors, systematic methods for accessioning and tissue gross examination preparation testing
analyzing and decreasing errors are most effective for error phases in the surgical pathology gross tissue examination
reduction. Use of Lean-based quality improvement programs room. Three full-time equivalent staff individuals and a super-
(LQIP) previously has been shown to improve laboratory visor worked in this area.
productivity and patient safety.4-7 Through a direct observa- Lean may be implemented in a number of ways, ranging
tion method, we previously reported a high level of baseline from a small focused intervention using specific Lean tools
active and latent factors in the surgical pathology system that to a large-scale implementation involving initiation of culture
contributed to near-miss events.3 Examples of these near- change and widespread changes in work processes led by
miss events include incorrect labeling of patient containers the frontline personnel. We chose the latter method of Lean
with surgical pathology accession number, incorrect pairing implementation in the entire anatomic pathology laboratory,
of one patient’s requisition with another patient’s specimen, including the areas of specimen accessioning and gross tissue

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and stacking cassettes for one patient’s specimen on to the examination described here. The timeline of the implemen-
specimen of another patient. We hypothesized that the imple- tation of this LQIP and the major events of the process are
mentation of an LQIP in the laboratory would reduce the shown in ❚Figure 1❚.
number of near-miss events in the accessioning and biopsy
gross examining areas of the laboratory. The purpose of this LQIP Components
study was to test our hypothesis by measuring the proportion
of near-miss events in these specific areas of our anatomic Lean Education
pathology laboratory before and after implementing an LQIP. The laboratory leaders and frontline staff who eventually
organized and directed the LQIP activities first attended Lean
courses that ranged from several hours to 4 days in duration
Materials and Methods (eg, Perfecting Patient Care course offered by the Pittsburgh
Regional Healthcare Initiative, Pittsburgh, PA).
LQIP Setting
We evaluated the effect of an LQIP on an anatomic Hoshin Kanri
pathology laboratory in an urban tertiary care medical cen- The laboratory leadership and frontline personnel facili-
ter that accessions approximately 20,000 surgical pathology tated a 2-day hoshin kanri goal-setting and cultural change

Clinical operation manager hired

Hoshin kanri

Rapid improvement event (kaizen)

Histology single piece flow implemented

New sign-out rooms

Resident Lean training

Post-QIP observations

Jan 2008 Apr 2008 Jul 2008 Oct 2008 Feb 2009 May 2009 Aug 2009 Dec 2009 Mar 2010

Gross room single piece flow implemented

Pre-QIP observations

Lab-wide perfecting patient care course

Quality improvement specialist hired

QIP kickoff
AP managers attend perfecting patient care course

❚Figure 1❚ Quality improvement program timeline.

368 Am J Clin Pathol 2012;138:367-373 © American Society for Clinical Pathology

368 DOI: 10.1309/AJCP3YXID2UHZPHT
 Anatomic Pathology / Original Article

event to set overarching aims for the LQIP. One of the 3 relationship between error type (ie, operator or process) and
anatomic pathology goals was the overall improvement of improvement after implementation.
clinical service quality, the goal from which the accessioning
and tissue gross examination kaizens (see below) emerged. Data Analysis
The pre-LQIP implementation error proportion was
Kaizens previously reported.3 The pre- and post-LQIP implementa-
The core activities of the LQIP involved the implementa- tion near-miss event proportions were calculated as follows:
tion of kaizens, or rapid improvement events (RIEs). In the (number of near-miss events/hours of observation)/(total
Lean model of work, less than optimal quality is attributed number of specimens accessioned/hours of observation).
to failures in work activities, connections, and/or pathways. Thus, the near-miss event proportions represented number of
During the RIEs, work activities and their associated con- near-miss events per specimen. Pre- and post-LQIP near-miss
nections and pathways were directly observed by 1 or more proportions were compared using the differences-between-
nonparticipant observers, who identified near-miss errors in proportions test. Statistical significance was assumed at a P

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real time. The Lean A3 method was used during the kaizens value of less than or equal to .05.
to document error/current condition, root cause analysis,
ideal state, and action plan. In addition to the Lean method of
third-party observation, process mapping and timing evalu-
Results
ation were used to document the current condition. One or
more participant observers were also recruited to report near- The LQIP produced 164 individual A3 documents, with
miss events, because the frontline staff usually has a greater 29 devoted to the accessioning and gross examining area
familiarity and recognition of these events. Also, a blame-free of the laboratory. Examples of some of the individual A3
atmosphere was promoted to encourage the staff to report documents and the components of work affected are shown
near-miss events that may have been overlooked by the obser- in ❚Table 1❚.
vation process. The A3 root cause analyses showed that specimen flow
and batching were major contributors to process-dependent
Quality Improvement Changes near-miss events and were a primary target for improvement.
Methods to lower the frequency of process-dependent One A3 problem solution involved major alterations to speci-
failure generally involve redesign of work pathways and men flow to move from batching to a single-piece-flow model
the physical components of work connections or hand-offs. that incorporated aspects of a pull system and leveled out the
Methods to lower the frequency of operator failure gener- work load.
ally involve targeting breakdown points in work activities; a ❚Figure 2❚ and ❚Figure 3❚ show a process map of speci-
combination of workflow redesign and education or training men flow pre- and post-LQIP, respectively. A schematic
may lower the frequency of failures in skill and knowledge- representation of the pull system we developed is shown in
based tasks. ❚Figure 4❚.
After A3 action plans were devised during the kaizen, ❚Table 2❚ shows the number of pre- and post-LQIP
changes that could be made immediately were implement- process-dependent, operator-dependent, and total near-miss
ed. Those that could not be immediately implemented were events per specimen. All specimens during the post-LQIP
initiated, with follow-up and completion over the ensuing observation and measurement had at least 1 near-miss event
several weeks. associated with it. Statistically significant differences in pre-
and post-LQIP proportions were found for total near-miss
Post-LQIP Near-Miss Measurement events (P < .002) and process-dependent near-miss events (P
Two of the authors (M.L.S. and T.W.) used a nonpartici- < .001), but not for operator-dependent near-miss events.
pant direct observation method to measure the frequency of
near-miss errors in the accessioning area and gross examina-
tion room 15 months after the hoshin kanri. The near-miss
events were classified as operator- or process-dependent. In Discussion
addition, the A3 documents generated during the kaizens
were reviewed to determine the root causes of error that were Our LQIP was successful in dramatically decreasing the
targeted by the subsequent quality improvement changes in frequency of process-dependent near-miss events in the acces-
the accessioning and gross examination room areas. Each A3 sioning and gross examining area of the laboratory, though
was classified as targeting a specific component(s) of work the frequency of operator-dependent near-miss events did not
(ie, activity, pathway, and/or connection) to determine the significantly improve.

© American Society for Clinical Pathology Am J Clin Pathol 2012;138:367-373 369

369 DOI: 10.1309/AJCP3YXID2UHZPHT 369
Smith et al / Gross Room Quality Improvement

❚Table 1❚
A3 Document Examples and Work Components Affected

Problem Solution Type Driver

Specimen containers, requisitions, and cassettes are Transform work into a one-by-one process A, P Q
mixed up during accessioning and set-up
Requisition forms are missing and delay case sign-out Create visual cubbies to sort requisitions at CN T and C
  the time of accessioning
Redundant data are dictated by technicians, leading to Eliminate redundancies in dictation process CN T and C
discrepancies at transcription
Large batches of cases not making late processors leading Eliminate batching from specimen set-up CN, P Q
to delays in diagnosis
Patient verification step missing from gross examining step Standardized opening dictation to include A Q
  “patient name and MRN”
Lack of standard for cutoff times leads to marked Standardize cutoff times and arrange other A, CN Q, T
variation in turnaround time   services accordingly

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A, activities; CN, connections; C, cost; MRN, medical record number; P, pathways; Q, quality; T, time.

Biopsy tray
1

2 4

Files Cassette writer 5 6

3
7
Accessioning

grossing
computer

station

Biopsy
9

1 shelf for all specimens ready to gross 8

grossing station 3
Big specimen

Big specimen Big specimen

grossing station 1 grossing station 2

❚Figure 2❚ Current condition of accessioning, specimen set-up, and gross examination. Plan view of the work area. Batches of
specimens are dropped off through a window or door (1). Specimens and requisition forms are separated from each other and
stacked on the counter (2). Requisitions are taken into a clean area and accessioned into the laboratory information system (3).
Requisitions are then re-paired with the specimens on the counter (4). Cassettes are made for each case on a separate counter
(5). Cassettes are placed on top of the paperwork for each case (6). Tray of case ready for gross examination is delivered to
biopsy (7) or big specimen (8) gross examination area. The biopsy specimen is examined, data are dictated, and the specimen is
submitted into a cassette (9).

Specimen flow and pathway redesign from a batch, push- systems engineering process that allowed staff to work on
based system to a one-by-one, pull-based system with leveled only a single patient specimen at a time. If only a single
workload was a major contributor to the decrease in near- patient specimen is handled at a time there is no chance for a
miss events. There are many benefits of the single-piece-flow patient mix-up, an event that has the potential for catastrophic
model, including built-in quality, flexibility, increased floor results. Pull systems and work-leveling are required for the
space, and increased safety.8 From a laboratory perspective, single-piece-flow model to function properly. A pull-system
one of the most important is the single-piece-flow model’s is one in which the downstream customer signals an upstream

370 Am J Clin Pathol 2012;138:367-373 © American Society for Clinical Pathology

370 DOI: 10.1309/AJCP3YXID2UHZPHT
 Anatomic Pathology / Original Article

2
Accessioning
3 computer Files

Cassette writer
4

grossing
station

Biopsy
5

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Station 1 Designated shelf space Station 3 6

grossing station 3
Station 2

Big specimen
Big specimen Big specimen
grossing station 1 grossing station 2

❚Figure 3❚ Specimen flow following workflow redesign. Batches of specimens are dropped off through a window or door
(1). Specimens are placed on a counter in a queue for entering the work line (2). Each specimen is taken one at a time and is
accessioned (3) and cassettes are made (3). Specimen is put in queue for gross examination (4). Biopsy specimen is examined
grossly (5). A separate queue cart is positioned for big specimens that are placed on a designated shelf (6).

Staff 2 Staff 1
Specimen
drop-off
counter

Accessioning C B A
Specimen gross
cassette generation
and dictation
prepared for grossing
Specimen
drop-off
counter

Accessioning C B
Specimen gross
cassette generation
and dictation
prepared for grossing

❚Figure 4❚ Single-piece-flow model with a pull system. Staff 1 takes the specimen (A) closest and performs gross examination
and accessioning activities. The box holding specimen A is then replaced at the front of the inventory line (dashed box) and
specimens B and C move down the line. This empty box is the queue for staff 2 to perform the task of accessioning and
cassette generation for the next case. There is inventory of work for both staff 2 (specimens being dropped off in the laboratory)
and staff 1 (Case B and C in the queue).

© American Society for Clinical Pathology Am J Clin Pathol 2012;138:367-373 371

371 DOI: 10.1309/AJCP3YXID2UHZPHT 371
Smith et al / Gross Room Quality Improvement

❚Table 2❚
Comparison of Pre- and Post-LQIP Near-Miss Events

Process-Dependent Operator-Dependent
Hours of No. of Specimens No. of Near- Near-Miss Event Rate Near-Miss Event Total Near-Miss
Observation Observed Miss Events per Specimen Rate per Specimen Event Rate

Pre-LQIP 45 421 2,576 5.5 0.6 6.1

Post-LQIP 37 266 630 1.8 0.6 2.4

LQIP, Lean-based quality improvement program.

supplier when they are ready for more product. Without this leaders in the department denigrated the LQIP and continued
component, product piles up in batches. Heijunka, or leveling to blame gross examination room personnel for failures. With

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out the workload, attempts to make each set of activities take the absence of unified support, some frontline personnel
the same amount of time to complete. Without heijunka, some experienced a lack of empowerment and ability to change
workers are overworked and burn out while others may feel work activities.
underutilized and demoralized. D’Angelo and Zarbo10 studied defects in surgical pathol-
Although we found a significant decrease in the fre- ogy and found a 27.9% frequency of defects. This is a much
quency of process-dependent errors, we were unable to reduce lower frequency than we identified and likely is related to
the frequency to zero, which was our goal. Despite changes the definition of defect and the mode of defect identification.
in workflow, laboratory personnel still worked in batches on D’Angelo and Zarbo defined a defect as a flaw, imperfection,
some aspects of the process. One of the difficulties was our or deficiency in specimen processing that required a delay or
inability to affect the work processes of suppliers (eg, involv- work stoppage to return work to the sender. This definition
ing the assembly and transport of specimens to the laboratory) encompasses both operator- and process-dependent defects,
outside the laboratory domain. The laboratory still received but not process-related near-miss events that end up being
large batches of work periodically throughout the day. Set- corrected before moving down the line of work. Our operator-
ting a goal of zero defects was a point of discussion in our dependent defect rate is similar (just over 1 in 2 specimens)
laboratory. Although we recognize reduction of defects to compared with the data reported by D’Angelo and Zarbo (just
zero in a process involving humans is unrealistic, it is also under 1 in 3 specimens). D’Angelo and Zarbo relied on the
unacceptable as a group to tolerate any defects when patient self-reporting of defects as opposed to our direct observational
safety is at stake. A principle of Lean is the idea of continu- method which required more time and effort by a third-party
ous quality improvement. One approach is to have a goal of observer.
minimal defects with incremental goals of 50% reduction in Using a similar LQIP, we previously showed a marked
defects annually. increase in productivity and decrease in turnaround time in the
The LQIP had no effect on the near-miss frequency of histology unit of an anatomic pathology laboratory. Efficiency
operator-dependent events despite multiple Lean educational and timeliness are 2 other quality metrics (in addition to patient
experiences of and involvement by frontline staff. Several safety measured in our current study), indicating the complex-
factors likely contributed to this: (1) high staff turnover in the ity of metric development and tracking inherent in measuring
area (2 of 3 personnel left their positions), (2) lack of buy-in change. Many pathology departments lack the resources and
from frontline staff, and (3) a lack of training opportunities to laboratory information systems necessary to determine the
improve skill or knowledge-based skills. effectiveness of LQIP efforts. Laboratory personnel and lead-
Buy-in from frontline staff requires a unified leadership ers may use the lack of data to derail change efforts.
group with universal support for the change initiative. Kot- In conclusion, change in conditions that contribute to
ter9 described 8 sequential steps in leading successful change patient safety may be directly linked to targeting defective
efforts: establishing a sense of urgency, forming a power- anatomic pathology workflow processes. The underlying
ful guiding coalition, creating a vision, communicating the factors that lead to the change or failure to change are often
vision, empowering others to act, planning for short-term suc- poorly understood and need to be studied in greater detail for
cess, consolidation of efforts, and institutionalization of new dissemination of the methods of change, rather than the indi-
approaches. The lack of buy-in from some of the frontline vidual work elements that are altered.
staff suggested failures in creating a vision and empowerment.
For example, many histology section personnel (customers From the 1Department of Pathology, University of Colorado,
of gross examination room personnel) and some high-level Aurora, and 2Rocky Vista University, Parker, CO. Dr Smith is

372 Am J Clin Pathol 2012;138:367-373 © American Society for Clinical Pathology

372 DOI: 10.1309/AJCP3YXID2UHZPHT
 Anatomic Pathology / Original Article

now with the Department of Laboratory Medicine and Pathology, 5. Condel JR, Sharbaugh DT, Raab SS. Error-free pathology:
Mayo Clinic Arizona, Scottsdale, AZ, and Dr Raab is now with the applying lean production methods in anatomic pathology.
Dept of Laboratory Medicine, University of Washington, Seattle, Clin Lab Med. 2004:24:865-899.
Washington, and Memorial University of Newfoundland/Eastern 6. Zarbo RJ, Tuthill JM, D’Angelo R, et al. The Henry Ford
Health Authority, St John’s, Canada. Production System: reduction of surgical pathology in-process
misidentification defects by bar code-specified work process
Address reprint requests to Dr Smith: Dept of Laboratory standardization. Am J Clin Pathol. 2009;131:468-477.
Medicine and Pathology, Mayo Clinic, 13400 E Shea Blvd, 7. Raab SS, Andrew-Jaja C, Condel JL, et al. Improving
Scottsdale, AZ 85259; [email protected]. Pap test quality and reducing medical errors by using
Toyota Production system methods. Am J Obstet Gynecol.
2006;194:57-64.
8. Liker JK. The Toyota Way: 14 Management Principles from the
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373 DOI: 10.1309/AJCP3YXID2UHZPHT 373