669

REVIEW

What is quality in surgical pathology?

R E Nakhleh
...............................................................................................................................

J Clin Pathol 2006;59:669–672. doi: 10.1136/jcp.2005.031385

Quality in surgical pathology may be defined as accurate, MEASURING QUALITY IN SURGICAL

PATHOLOGY
timely, and complete reports. Achieving quality requires Then how do we define quality in surgical
substantial investment in the basic structure and in the pathology? Elements of quality that are impor-
people who undertake surgical pathology. Quality tant in surgical pathology include report accu-
racy, timeliness, and report completeness.4 In
assurance and improvement works best when it is woven manufacturing, one typically adds price or cost
into the systems of surgical pathology with well informed, into the expectation of quality. However, in the
well trained, and knowledgeable staff. current system of third party payers in medicine,
price has been diminished in consideration of
...........................................................................
quality.
If it is agreed that accuracy, timeliness, and
completeness are desired features in surgical
pathology, then designing a quality assurance

Q
uality is a pervasive term that is perhaps and improvement (QA&I) plan should focus on
overused. Quality assurance and improve- these three elements. Typical quality assurance
ment plans in surgical pathology seek to and improvement plans contain five categories of
‘‘assure’’ and ‘‘improve’’ surgical pathology monitors (table 1).5–9 The first three categories
‘‘products’’. To accomplish this, basic notions include the entire test cycle (pre-analytic, analy-
such as quality and product must be defined and tic, and post-analytic phases). A reason for this
understood. In this article, the definition of design is the rationale that defects may occur at
quality and how it applies to surgical pathology any point in the test cycle, resulting in an
is explored. Quality attributes of a surgical erroneous diagnosis, so the entire test cycle
pathology laboratory are defined, with a discus- should be monitored.10 Another reason is the
sion of how those attributes are measured in the desire for subsets of the process to work well
context of a quality assurance and improvement together in producing a final product. Therefore,
plan. In addition, other factors are presented that by examining the process in its entirety and in
are needed to achieve a structure that maintains detail one may introduce modifications within
output of a quality product. the process that ultimately improve the product.
The majority of monitors within the three phases
of the test cycle are used to assure accuracy,
although relatively few are focused on the actual
QUALITY diagnosis. Completeness is usually addressed in
Quality has several definitions.1 It may be post-analytic phase monitors, even though many
defined as an attribute of an individual or object. elements of completeness have their roots in the
More often quality is defined as superiority of analytic phase of the test cycle.7
kind or as a level of excellence. Quality, however, The other two categories of monitors are
has taken on more specific definitions that relate turnaround time (TAT) and customer or clinician
to manufacturing or industrial production.2 satisfaction. Timeliness is entirely addressed by
Some have defined quality as ‘‘conformance to TAT monitors. Customer or clinician satisfaction
specifications’’, others have suggested that qual- aims to measure the whole process from the
ity is meeting or exceeding customers’ expecta- clinician’s perspective. The following is a brief
tions. In this context, the definition of quality is discussion of QA&I plan monitors and how they
related to the product made or service rendered. measure surgical pathology accuracy, timeliness,
Therefore quality measures may need to be and completeness.
customised. In industry, six sigma has emerged
as a generic quality standard.3 This standard Pre-analytic phase
aims to have the total number of failures in In the pre-analytic phase of the test cycle several
quality, or customer satisfaction at 3.4 defects or elements may be monitored. Patient or specimen
fewer than 4 defects per 1 000 000 products. This identification, however, is the most important of
....................... is derived from statistical methods at the level of these elements. Mishaps in specimen identifica-
six sigma or six standard deviations of likelihood tion have led to unwarranted procedures and
Correspondence to: in a normal distribution of customers. By
Dr Raouf E Nakhleh, very dramatic headlines in the lay press.11 It is
Department of Pathology, comparison, various studies have estimated critical that a specimen is reported on the correct
4201 Belfort Rd, St Luke’s surgical pathology error rates from as low as patient and this begins with specimen labelling
Hospital/Mayo Clinic 0.25% (2500 per million) to as high as 40%.4
Jacksonville, Jacksonville,
FL 32216, USA; nakhleh.
Most investigators, however, agree that a sig- Abbreviations: CoC, Commission on Cancer; FISH,
raouf@mayo.edu nificant error rate in surgical pathology is in the fluorescent in situ hybridisation; QA&I, quality assurance
....................... range of 0.5% to 1%. and improvement; TAT, turnaround time

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670 Nakhleh

Table 1 Quality assurance and improvement monitors in a diagnosis, including gross dissection and section,
embedding, histological sectioning, staining, special and
Pre-analytic immunohistochemical staining, possible other ancillary
Specimen fixation studies, and microscopic interpretation. The accuracy of the
Specimen delivery
Specimen identification final diagnosis is a measure of the effectiveness of all of these
Adequacy of clinical history sequential steps.
Accessioning errors In the absence of a better method, judging the correctness
of surgical pathology diagnoses has become an exercise in
Analytic
Intra-operative peer review and may be the most important measure of
Frozen section – permanent section concordance quality with respect to patient care.15 Different methods of
Final diagnosis peer review have been used (table 2). However, no single
Peer review error rate
method has been shown to be superior in detecting errors.
Histology and gross room monitors
Block labelling errors Second review of cases before verification has been shown to
Slide labelling errors reduce the number of amended reports.16 17 Thus as a
Slide quality preventative measure many institutions have installed
Immunohistochemistry
second pathologist review before sign-out on selected cases
Frequency of repeat slides
Annual inventory of antibodies and frequency of use (for example, breast biopsies, pigmented skin lesions).
External validation of selected antibodies All measures in the analytic phase aim to improve
Other ancillary study monitors include monitors for FISH, EM, other diagnostic accuracy, including monitors of histology or
molecular studies
immunohistochemistry quality as well as other ancillary
Post-analytic studies such as in-situ hybridisation. Monitors of immuno-
Transcription errors histochemistry may become more important in the future,
Verification errors particularly for markers that determine treatment, such as
Report delivery errors
Incomplete reports
Her2/neu.18
Diagnostic finding correlation with ancillary studies (IHC, EM, FISH)
Post-analytic phase
Turnaround time (TAT)
Frozen section
The post-analytic phase of the test cycle begins with dictation
Biopsy of the gross and microscopic examination and the final
Large specimen diagnosis and includes transcription, report correction,
Preliminary and final necropsy reports verification, and report delivery.7 Keys in the post-analytic
Clinician satisfaction and/or complaints
phase are accurate transcription, complete reporting, and
Overall satisfaction report delivery. Only recently has the issue of complete
Diagnostic accuracy reporting in surgical pathology been given sufficient atten-
Frozen section timeliness and accuracy tion. There is a drive toward evidence based medicine.19 This
Report timeliness
Report completeness
is particularly important in oncology, where many protocols
Pathologist availability are dependent on the pathological staging of tumours. The
Recent changes Cancer Program Standards 2004 publication of the Commission
on Cancer (CoC) requires that 90% of pathology reports that
EM, electron microscopy; FISH, fluorescent in situ hybridisation; IHC,
immunohistochemistry.
include a cancer diagnosis will contain the scientifically
validated data elements outlined on the surgical case
summary checklist of the College of American Pathologists
and accessioning. This process is multifactorial and involves (CAP) publication, Reporting on Cancer Specimens.20 21 The use
many individuals outside the laboratory. Therefore, signifi- of summary checklists has been shown to be very effective in
cant improvement in specimen identification requires accep- providing more complete reports.22 In view of the CoC
tance of this goal across an institution with a substantial standard, monitoring of report completeness for cancer
awareness campaign and the use of stringent labelling resection seems necessary and worthwhile. Other situations
standard.12 Fortunately, accrediting bodies such as the Joint where report completeness is an issue include CAP standards
Commission for Accreditation of Healthcare Organizations for the correlation of histopathology with previous cytological
and the College of American Pathologists have made accurate or histological material and with various ancillary studies.23
patient identification a cardinal patient safety goal. As stated above, TAT is a critical element of quality and
Other critical elements in the pre-analytic phase include usually covers all aspects of the laboratory test cycle. While
lost specimens, appropriate fixation, and adequate clinical TAT may be fragmented into smaller components, the total
history.13 Most of the elements of the pre-analytic phase aim TAT is the only measure by which the clinician or customer
at improving the accuracy of diagnosis, particularly adequate will judge the laboratory.24 Smaller components, however, are
clinical history. Clinical history has been shown to affect the important to understand when an intervention is planned to
accuracy and completeness of pathology reports.14 improve the total TAT.
Unfortunately, we are unaware of studies that have Customer or clinician satisfaction is probably one of the
attempted improvement of adequate clinical history received most important measures of quality because it lends insight
with specimens. into the clinician’s perception of the laboratory. While there
are many elements that when combined add up to a quality
Analytic phase laboratory, clinician satisfaction is also based on the
The analytic phase of the test cycle begins with gross additional factor of expectations.25 26 Thus a laboratory may
examination of the specimen and ends with diagnosis. All have accurate, timely, and complete reports, yet a clinician
manipulations of the specimen subsequent to gross exam- may still have the perception of poor quality if they have
ination, such as histological preparation and immunohisto- unrealistic expectation. Therefore, in addition to managing
chemistry, that lead to a diagnosis are therefore components and monitoring all the elements of quality, the pathologist
of the analytic phase of the test cycle. Most critical in this must also manage clinician expectations and make sure that
phase is the act of diagnosis itself. Many elements culminate they are realistic. Without some effort to obtain clinician

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Surgical pathology quality 671

Table 2 Different methods of peer review

Review of a randomly selected percentage of cases
Focused internal review of specific organ system or malignancy type (for example, breast cancer)
Interdepartmental conferences (for example, tumour board)
Intradepartmental quality assurance conference
Frozen section/permanent section correlation
Cytology/surgical pathology correlation
Review of previous pathology material
Intradepartmental review of material before release to other institutions.
Review of outside diagnosis of in-house cases

feedback, some problems—at least from the clinicians’ confirm the patient’s identity at accession. Subsequently,
perspective—may never be identified. blocks and slides would be labelled automatically with the
accession number and the patient’s name and any other
STRUCTURAL COMPONENT OF A QUALITY identifying information. The system would provide tracking
SURGICAL PATHOLOGY LABORATORY mechanisms through the use of bar code or similar
A quality assurance and improvement plan is merely a small technology, so that all cases, blocks, slides, and reports are
component in maintaining a quality laboratory. Quality in a accounted for throughout the process. In addition, bar code
laboratory is dependent on a host of structural and personnel technology would be used to input dictation and transcrip-
factors that are necessary, regardless of the QA&I plan. Even tion so that misidentification errors are reduced. A compre-
better, quality assurance and improvement must be weaved hensive computer system could check and alert if reports
into all the other systems of the laboratory to achieve the have incomplete elements or if cases are not completed
absolute best results. The following is a discussion of critical within a reasonable time. Such a system could then deliver
elements needed to maintain a quality laboratory. reports electronically to the ordering physician as well as to
other venues such as tumour registries. Finally, a compre-
Work force hensive computer system could generate numerous quality
A flexible, well trained, knowledgeable staff is key to the reports in real time and could offer alerts when set
success of any organisation. This applies to all levels of work parameters are not met.
within surgical pathology, including pathologists, patholo-
gist’s assistants, histology staff, and the secretarial staff. Standardised tasks and language
Important aspects in building the staff are qualifications, Quality laboratories have set predetermined standardised
suitability, sufficient redundancy, and the ability to work procedures that are easily accessible and well known by the
with others.27 Of course, individuals must have the appro- staff. A key to quality is the elimination of competing
priate qualifications for the jobs they are doing, but more procedures.27 This is beneficial in reducing confusion over
importantly people must be suited to their duties. Individuals which procedures should be followed, but more importantly
with the same qualifications may have vastly different it leads to tremendous efficiencies in laboratory operations.
strengths and weaknesses and must be placed in positions Employees must be trained in accepted procedures as they
to take advantage of their strengths, doing the opposite is a are hired, but also regularly updated as procedures are
sure recipe for failure. In building a work force, sufficient modified.
redundancy in skills is critical to assure continuity or work Just as important is the standardisation of terms used
functions are not affected during an individual’s absence. within the laboratory and in communication with clinicians
Finally, the staff should work together as a team. The ability and physician’s offices outside of the laboratory, including
to work with others is critical for maintaining a healthy diagnostic terminology. Diagnostic terminology is constantly
environment and is beneficial to patient safety.28 being revised and laboratories must have mechanisms to
review and update diagnostic criteria and terminology
Continuous education and training annually. By the same token, this needs to be communicated
Medical knowledge and treatment is constantly changing. to all who are likely to encounter these terms. To reduce
The medical staff must constantly seek out new knowledge confusion and enhance customer satisfaction, clinicians
and adopt new practices as they become available. These new should be included.
concepts should be shared and discussed with colleagues,
and collectively either adopted or rejected. As individuals are The ability to change
hired they should be trained to the specific peculiarities of Key to the success of most organisations is their ability to
their jobs within a particular institution. Individuals should respond to challenges quickly and effectively. Inherent in
also have regular training in a host of other areas, such as these organisations is an ability to adapt and change. While
safety and quality improvement, as well as any impending the basis of surgical pathology practice has not changed
changes in their job duties. significantly over the past half century, changes in the
approach to individual diseases are occurring at a much more
Comprehensive computer system rapid pace. Breast cancer is a prime example of this evolution.
A comprehensive computer system can greatly enhance the Thirty years ago a pathology report on a breast cancer
quality of a surgical pathology laboratory.29 30 While all the included a diagnosis and lymph node status. Today a report
necessary technology is available, comprehensive computer should include a diagnosis, tumour grade, tumour size,
systems are rare. The ideal system has the ability to pull vascular involvement, lymph node status, margin status, and
together all the components of surgical pathology with distance to margin if negative, oestrogen and progesterone
integrated quality assurance and quality control checks. receptor status, Her2/neu immunostain, and possibly a FISH
One may envision a system that allowed physician remote result. Along the way several other factors such as flow
order entry so that the clinical history is mandated and cytometry and proliferation markers were at one point
specimens are accounted for as they arrive. A comprehensive thought to be important and were included in pathology
system would be tied with an institutional database to reports, but have now been shown to be less significant in

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672 Nakhleh

determining outcome or treatment and therefore may not 13 Nakhleh RE, Zarbo RJ. Surgical pathology specimen identification and
accessioning: a College of American Pathologists Q-Probes study of
need to be included. Although at variable rates, this type of 1,004,115 cases from 417 institutions. Arch Pathol Lab Med
evolution is occurring in many disease processes. A quality 1996;120:227–33.
surgical pathology laboratory must remain current with all of 14 Nakhleh RE, Gephardt G, Zarbo RJ. Necessity of clinical information in
surgical pathology: a College of American Pathologists Q-probes study of
these changes and ideally serve as a source of information to 771,475 surgical pathology cases from 341 institutions. Arch Pathol Lab Med
clinicians served by that laboratory. 1999;123:615–19.
15 Zarbo RJ, Meier FA, Raab SS. Error detection in anatomic pathology. Arch
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16 Nakhleh RE, Zarbo RJ. Amended reports in surgical pathology and
Finally, it may be superfluous to say that a laboratory must be implications for diagnostic error detection and avoidance: a College of
in regulatory compliance to operate. Of course this is American Pathologists’ Q-probes study of 1,667,547 accessioned cases in
necessary for licensure, but more importantly, regulatory 359 laboratories. Arch Pathol Lab Med 1998;22:303–9.
standards are helpful in guiding laboratories to set up policies 17 Novis DA. Detecting and preventing the occurrence of errors in the practices
of laboratory medicine and anatomic pathology: 15 years’ experience with
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immunohistochemistry. Am J Surg Pathol 2001;25:1208–10.
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analysis, and pathology. Hum Pathol 2004;35:1179–88.
20 Commission on Cancer. Standard 4.6. The guidelines for patient
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