**4. Looking for solutions**

lymph node compromised by cancer, a polyp in the gallbladder, and breast carcinomas are not described in the first macroscopic description. These errors delay delivery results because

Delays in the report release may be considered as an error in the post-analytical [15] or analytical phase [16], and the turn-around time (TAT) should be used as an important quality measure in laboratories [32]. It is not uncommon for the pathologist to miss the perception that there is a patient waiting for his results; therefore, the cases should not remain for longer than necessary on the pathologist's desk [33]. Delays in TAT may be considered during the pre-analysis as delays in reception, gross examination, and material processing; during the analysis (in the diagnostic interpretation of the pathologist) or after the analysis, as the delay in typing and release of the reports to the patient. In a study performed with 713 cases of surgical pathology, 551 (77%) were released in 2 days and 162 (23%) in 3 days or more. From these, the majority of these cases were found to be pertaining to lungs, gastrointestinal tract, breasts, and samples of the genitourinary tract. Diagnosis of malignancy (including staging), consultations with other pathologists, freezing, and immunohistochemical analysis were associated with increased TAT in univariate analysis. In the multivariate analysis, the consultation with other pathologists, the diagnosis of malignancy, the use of immunohistochemistry, and the number of slides evaluated (11.3 when TAT > 2 days and 4.8 when TAT ≤ 2 days) remain as significantly associated with increased TAT. Despite CAP recommendation of an analytical response time of 2 days or less for most routine cases, the authors conclude that cancer care

In post-analytical phase, errors include typographical errors, and in some cases, it can lead to catastrophic consequences, when the expression "cancer is present" instead of "cancer is not present." Another error in this phase included erroneous or missing non-diagnostic information, computer formatting, or transmission [29]. Besides that, some expressions can lead to confusing interpretations. It is broadly used in some expressions or phrases to communicate varying degrees of diagnostic certainty, for example, "cannot rule out," "consistent with," "highly suspicious," "favor," "indefinite for," "suggestive of," and "worrisome for." Lindley, Gillies, and Hassell evaluated 1500 surgical pathology reports and found 35% of these expressions, with wide variation in the percentage of certainty clinicians assigned to the phrases studied. The most commonly used phrases were "consistent with" (50%) and "suggestive of" (39%). The authors believe that the reasons for use for this expression may include contradictory or low probability staining results, inconsistency in clinical data, uncertain criteria in the medical literature, quantity of sample or abnormality, and possibly a concern with medicolegal

Nakhleh and Zarbo describe the amended reports from 359 laboratories, 96% of the USA, participants in the 1996 Q-Probes quality improvement program of the College of American Pathologists. A total of 3147 amended reports from 1,667,547 surgical pathology specimens accessioned in the study. They describe a median of amended reports was 1.5/1000 cases; of these, 19.2% were issued to correct patient identification errors, 38.7% to change the originally issued final diagnosis, 15.6% to change a preliminary written diagnosis, and 26.5% to change clinically significant information other than the diagnosis. The error detection was most commonly precipitated for a request from a clinician to review

they require a new specimen exam.

100 Quality Control in Laboratory

institutions should have a TAT longer than other services [34].

consequences for an over- or under-diagnosis.

a case (20.5%) [35].

Perkins [36] considers that the disclosure of errors in pathology is complicated by factors intrinsic to the specialty. The first barrier, as already mentioned, is the definition of error. Another concern is that the patient does not understand the nature of the error or even that the clinician is unable to explain it adequately to the patient. Even more complex is the situation that involves the discovery of the error of another individual: when the pathologist or the head of the laboratory discovers an error of a technician/ pathologist in their laboratory or external laboratories, or even when the pathologist discovers an error of a clinician from the same organization. Therefore, when disclosing an error, the pathologist must consider the potential impact on their professional relationships. It is difficult sometimes to define an error because there exists a great variability in definitions used in the literature. The most commonly utilized is a classification in pre-analytical, analytical, and post-analytical phases, but we note that the errors can overlap between these categories. For example, change of specimen can occur in pre-analytical and analytical phase. Incorrectly described laterality or anatomic sites may occur in any step at the laboratory. Because of that, the comparison of studies in literature can be difficult, as the authors used different definitions in their studies. We described a risk assessment of laboratory errors in surgical pathology in a fishbone diagram (**Figure 5**).

One factor conferred to the increase in the number of medical errors is the excessive decentralization of patient care. Since the patient may have several professionals working in different contexts and none with access to the complete information, the physician would work in a situation of greater susceptibility to error [1]. The lack of complete information is critical in pathology, where many cases depend on correct, clear, and complete clinical information for adequate clinical-pathological correlation. In some cases, radiological or laboratory correlation is required. In soft tissue and bone neoplasms, it is important that the pathologist

**Figure 5.** Risk assessment using a fishbone diagram.

is able to interpret radiological exams. The correlation with laboratory data is fundamental for interpretation of hepatic biopsies and to define etiology of hepatitis.

In a review article by Ellis and Srigley [39], the authors emphasized the importance of structured and standardized reports for the improvement of diagnostic quality. Standardized reports can provide data that contribute to quality improvement programs in health care and, when combined with other health data sources, provide important information for monitoring, improvement, possible interventions, and benefit analyses in services offered to the population. The standardization of reports has proved to be particularly important in oncological diagnoses, which can generate much information with epidemiological impacts. The International Collaboration on Cancer Reporting maintains the guidelines and all the necessary parameters in the histopathological report at http://www.iccr-cancer.org/datasets to guide clinical management, as well as to provide prognostic information for several cancers; the guidelines panel is a result of a six-week public consultation conducted by a Dataset Authoring Committee, with multidisciplinary experts. Lehr and Bosman [33], in an article about the communication skills of pathologists, discourage the excess of additional notes on artifacts from improper pre-laboratory handling, such as incorrect fixation due to electrocautery, and so on. The authors advise that if the problems become recurrent, a letter to the material source services with guidelines may help to

Errors in Surgical Pathology Laboratory http://dx.doi.org/10.5772/intechopen.72919 103

Nakhleh et al. [37] state that it is natural to wish to use data from case reviews to measure the quality of a pathology laboratory; however, now, it is not clear how best to interpret these results, which should not be used to compare the quality between two different laboratories. There are some limitations that may explain such facts: the sources of error, as well as their definitions, and the methods used for their measurement, which may differ between laboratories. Its clinical impacts may be different. The sensitivity of the evaluation method is not controlled and is unknown; in addition, the expected performance points are

The errors in anatomical pathology have been screened in an internal assessment (review of diagnoses, correlation review of cytological and histological diagnoses, or between frozen section and permanent diagnoses, clinicopathological conference review of incoming cases, and intradepartmental cases or an intradepartmental consultation). The external assessment can be done across with regard to participation in quality assurance programs or medicolegal claims. Some authors recommended that two pathologists sign-out every cancer diagnosis [40]; how-

Raab et al. [41] performed a nonconcurrent cohort study to compare the effectiveness and usefulness of error screening using a targeted 5% random review process (selected by a laboratory information system) and a focused review process. The last was performed in three subspecialties: gastrointestinal subspecialty, bone and soft tissue, and genitourinary pathology. In this study, pathologists reviewed 7444 cases using a targeted 5% random review process and 380 cases using a focused review process and describes 195 (2.6% of reviewed cases) and 50 (13.2%) errors detected by the procedures, respectively (*p* < 0.001). The focused review process detected approximately four times much more errors than the targeted 5% random review process, despite this last process involving the examination of almost 20 times the number of specimens. Major errors detected by the first process was 27 (0.36%) and 12 (3.2%)

ever, this entails greater manpower, a luxury not enjoyed by a few laboratory [29].

improve the specimens.

not well defined.

In 2016, CAP, the Laboratory Quality Center, and the Association of Directors of Anatomic and Surgical Pathology convened a panel of experts to develop a guideline to help define the role of case reviews in surgical pathology and cytology. The main recommendations cited in the document, with strong agreement among the participants were: (1) pathologists should develop procedures for the evaluation of selected cases in order to detect divergences and possible interpretation errors, (2) pathologists should conduct case reviews timely to prevent negative impacts on patient care, (3) pathologists should have review procedures of cases relevant to their practice, as well as continuously monitor and document the results of case reviews, and (4) if case reviews show unsatisfactory concordances for a defined case type, the pathologists should take action to improve diagnostic compliance. The situation may become a little more problematic in places where only one pathologist is responsible for all cases; almost all published data refer to situations in which there is a second pathologist responsible for the review. The authors understand that there may be a value addition when the pathologist himself revises his cases in the second moment; however, there are not enough data in the literature. Each laboratory should develop written procedures and record the results of its departmental review studies. According to the authors, the causes for low agreement within and among anatomopathological groups are multiple, but two factors need to be discussed. Some diagnoses have intrinsically greater variation between observers, and these differences should be considered. Furthermore, the histological diagnosis is dynamic and different terminologies can be used for the same disease. If a poor interobserver agreement is evidenced, methods for improvement should be implemented, such as consensus conferences, images for comparison, and so on; however, the quality of evidence is very low regarding the best method of improvement. The authors consider that best practices may differ according to the characteristics of the disease, individual practices, and complementary tests available [37].

Smith and Raab [9] describe how to use the Lean A3 quality control method in surgical pathology. Under the Lean method, a management philosophy developed by Toyota Motor Corp., pathologists develop activities, that is, examination of slides, diagnostics, and preparation of reports from paths through the sequential flow of the sample, with connections, represented by the individuals with whom the pathologist communicates. At all stages, there is the possibility of error, and quality improvements should focus on repairing these failures. The A3 method is based on defining a problem, analyzing its causes, aiming at an ideal practice, and providing an improvement plan [9]. Other authors have also used industrial techniques, such as the Six Sigma, with excellent results in error reduction [16, 38]. Examples of their measures were as follows: meetings with the clinical teams responsible for delivering the material to correct the inadequacy of the samples and intradepartmental meetings, in which employees actively participated in the discussions about the errors and their solutions. In the pre-analytical phase, the authors established a double-check system of the material, with the work divided into successive stages, and at each stage, all specimens were listed and checked by two team members, from receipt to material processing, and were subjected to the supervision of a quality control unit [16].

In a review article by Ellis and Srigley [39], the authors emphasized the importance of structured and standardized reports for the improvement of diagnostic quality. Standardized reports can provide data that contribute to quality improvement programs in health care and, when combined with other health data sources, provide important information for monitoring, improvement, possible interventions, and benefit analyses in services offered to the population. The standardization of reports has proved to be particularly important in oncological diagnoses, which can generate much information with epidemiological impacts. The International Collaboration on Cancer Reporting maintains the guidelines and all the necessary parameters in the histopathological report at http://www.iccr-cancer.org/datasets to guide clinical management, as well as to provide prognostic information for several cancers; the guidelines panel is a result of a six-week public consultation conducted by a Dataset Authoring Committee, with multidisciplinary experts. Lehr and Bosman [33], in an article about the communication skills of pathologists, discourage the excess of additional notes on artifacts from improper pre-laboratory handling, such as incorrect fixation due to electrocautery, and so on. The authors advise that if the problems become recurrent, a letter to the material source services with guidelines may help to improve the specimens.

is able to interpret radiological exams. The correlation with laboratory data is fundamental for

In 2016, CAP, the Laboratory Quality Center, and the Association of Directors of Anatomic and Surgical Pathology convened a panel of experts to develop a guideline to help define the role of case reviews in surgical pathology and cytology. The main recommendations cited in the document, with strong agreement among the participants were: (1) pathologists should develop procedures for the evaluation of selected cases in order to detect divergences and possible interpretation errors, (2) pathologists should conduct case reviews timely to prevent negative impacts on patient care, (3) pathologists should have review procedures of cases relevant to their practice, as well as continuously monitor and document the results of case reviews, and (4) if case reviews show unsatisfactory concordances for a defined case type, the pathologists should take action to improve diagnostic compliance. The situation may become a little more problematic in places where only one pathologist is responsible for all cases; almost all published data refer to situations in which there is a second pathologist responsible for the review. The authors understand that there may be a value addition when the pathologist himself revises his cases in the second moment; however, there are not enough data in the literature. Each laboratory should develop written procedures and record the results of its departmental review studies. According to the authors, the causes for low agreement within and among anatomopathological groups are multiple, but two factors need to be discussed. Some diagnoses have intrinsically greater variation between observers, and these differences should be considered. Furthermore, the histological diagnosis is dynamic and different terminologies can be used for the same disease. If a poor interobserver agreement is evidenced, methods for improvement should be implemented, such as consensus conferences, images for comparison, and so on; however, the quality of evidence is very low regarding the best method of improvement. The authors consider that best practices may differ according to the characteristics of the disease, individual practices,

Smith and Raab [9] describe how to use the Lean A3 quality control method in surgical pathology. Under the Lean method, a management philosophy developed by Toyota Motor Corp., pathologists develop activities, that is, examination of slides, diagnostics, and preparation of reports from paths through the sequential flow of the sample, with connections, represented by the individuals with whom the pathologist communicates. At all stages, there is the possibility of error, and quality improvements should focus on repairing these failures. The A3 method is based on defining a problem, analyzing its causes, aiming at an ideal practice, and providing an improvement plan [9]. Other authors have also used industrial techniques, such as the Six Sigma, with excellent results in error reduction [16, 38]. Examples of their measures were as follows: meetings with the clinical teams responsible for delivering the material to correct the inadequacy of the samples and intradepartmental meetings, in which employees actively participated in the discussions about the errors and their solutions. In the pre-analytical phase, the authors established a double-check system of the material, with the work divided into successive stages, and at each stage, all specimens were listed and checked by two team members, from receipt to material processing, and were subjected to the

interpretation of hepatic biopsies and to define etiology of hepatitis.

102 Quality Control in Laboratory

and complementary tests available [37].

supervision of a quality control unit [16].

Nakhleh et al. [37] state that it is natural to wish to use data from case reviews to measure the quality of a pathology laboratory; however, now, it is not clear how best to interpret these results, which should not be used to compare the quality between two different laboratories. There are some limitations that may explain such facts: the sources of error, as well as their definitions, and the methods used for their measurement, which may differ between laboratories. Its clinical impacts may be different. The sensitivity of the evaluation method is not controlled and is unknown; in addition, the expected performance points are not well defined.

The errors in anatomical pathology have been screened in an internal assessment (review of diagnoses, correlation review of cytological and histological diagnoses, or between frozen section and permanent diagnoses, clinicopathological conference review of incoming cases, and intradepartmental cases or an intradepartmental consultation). The external assessment can be done across with regard to participation in quality assurance programs or medicolegal claims. Some authors recommended that two pathologists sign-out every cancer diagnosis [40]; however, this entails greater manpower, a luxury not enjoyed by a few laboratory [29].

Raab et al. [41] performed a nonconcurrent cohort study to compare the effectiveness and usefulness of error screening using a targeted 5% random review process (selected by a laboratory information system) and a focused review process. The last was performed in three subspecialties: gastrointestinal subspecialty, bone and soft tissue, and genitourinary pathology. In this study, pathologists reviewed 7444 cases using a targeted 5% random review process and 380 cases using a focused review process and describes 195 (2.6% of reviewed cases) and 50 (13.2%) errors detected by the procedures, respectively (*p* < 0.001). The focused review process detected approximately four times much more errors than the targeted 5% random review process, despite this last process involving the examination of almost 20 times the number of specimens. Major errors detected by the first process was 27 (0.36%) and 12 (3.2%) detected by focused review processes with statistical difference (*p* < 0.001). The authors concluded that the focused review detects a higher proportion of errors and may be more effective in strategies for errors screening.

**Author details**

**References**

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Monique Freire Santana\* and Luiz Carlos de Lima Ferreira

University Hospital Getulio Vargas, Amazon, Brazil

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\*Address all correspondence to: monique.freire20@gmail.com

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In some cases, the pathologists consult extradepartmental experts to achieve the better diagnostic accuracy, and it is known that the diagnostic criteria vary according to the pathologist's experience. For this reason, it is common to use the same expert for various pathologists. The principal limitation of this approach is the high selectivity of the cases because only extraordinary cases must be evaluated by other pathologists, and this does not exclude apparently routine cases that must be false-negative [7]. Besides that, the use of expert consultants does not exclude the legal responsibility for the first pathologist. In these situations, called "vicarious liability," the first pathologist assumes legal responsibility for having chosen a negligent consultant [30].
