Context.—The Q-Probes program is a peer-comparison quality assurance service offered by the College of American Pathologists that was created in 1989.

Objective.—To establish national benchmarks around a specific quality metric at a specific point in time in anatomic pathology (AP).

Design.—Q-Probes are based on a voluntary subscription for an individual study. Hospital-based laboratories in the United States, Canada, and 16 other countries have participated. Approximately one-third of all Q-Probes studies address AP metrics. Each Q-Probes study has a primary quality indicator and additional minor indicators.

Results.—There have been 52 AP Q-Probes studies addressing process-, outcome-, and structure-related quality assurance issues. These Q-Probes studies often represented the first standardized national benchmark for specific metrics in the disciplines of cytopathology, surgical pathology, and autopsy pathology, and as such have been cited more than 1700 times in peer-reviewed literature. The AP Q-Probes studies that have been repeated over time demonstrate improvement in laboratory performance across an international spectrum.

Conclusions.—The Q-Probes program has produced important national benchmarks in AP, addressing preanalytic, analytic, and postanalytic factors in the disciplines of cytopathology, surgical pathology, and autopsy pathology. Q-Probes study data have been published, cited, and used in the creation of laboratory accreditation standards and other national guidelines.

The Quality Practices Committee (QPC) of the College of American Pathologists (CAP) was created when the Quality Assurance Service committee was split into a quality control branch and a quality assurance branch in 1989. This occurred 1 year after the introduction of Q-Probes. The quality assurance branch is what ultimately became the QPC and was charged to develop customer-focused, scientifically validated metrics in order to document performance and outcome measures in laboratories and health care delivery systems. The committee also was charged with educating pathologists and the larger health care community about laboratory quality.

Q-Probes were created by the QPC as a voluntary peer-comparison product to be offered by the CAP. The intention was to perform an in-depth analysis of a particular procedure, outcome, or structure in either the anatomic or clinical pathology laboratory. In 1989, participants in the first Q-Probes study began gathering data regarding the diagnostic accuracy of frozen section diagnoses.1  In the ensuing 25 years, 52 Q-Probes studies focused on anatomic pathology have been conducted (Table 1), representing the work of 33 authors and coauthors, and resulting in 54 publications in the Archives of Pathology & Laboratory Medicine.154  Participants from the United States, Canada, and 16 other countries have participated and submitted data to help develop benchmarks. The vast majority of this work has been published, either in Archives of Pathology & Laboratory Medicine or in another peer-reviewed journal, resulting in more than 1700 citations.

Table 1. 

Demographics of Q-Probes Anatomic Pathology Studies, 1989–2014

Demographics of Q-Probes Anatomic Pathology Studies, 1989–2014
Demographics of Q-Probes Anatomic Pathology Studies, 1989–2014

These Q-Probes and their subsequent analysis and publication have produced significant impact on anatomic pathology practice in the areas of surgical pathology, cytopathology, and autopsy pathology. In these and other areas, Q-Probes studies often represented the first multi-institution, scientifically validated benchmarking data available. More recent Q-Probes have included an analysis of compliance with CAP cancer protocols for surgical pathology reporting and application of guidelines for human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) performance and interpretation. This article highlights the 25-year effort of the CAP QPC and the overall impact of anatomic-pathology–focused Q-Probes studies.

The Q-Probes program is a peer-comparison quality assurance service offered by the CAP. Q-Probes are designed as a one-time, in-depth study of a specific metric. Voluntary participants were provided forms containing a survey of their demographic information and practice distribution. Participants were also provided with appropriate data collection forms relevant to the topic at hand. Detailed instructions including definition of terms, tally worksheets, and input return forms were provided. Deadlines for return of data to CAP were enforced. Following data analysis, participants received a report of their performance along with a percentile ranking for comparison with other participating institutions. A written summary from the study's authors was also provided.

For this article, warehoused documents from the CAP including accreditation checklists and prior Q-Probes studies were compiled and reviewed. A review of the literature surrounding individual anatomic pathology–related Q-Probes studies was performed, and the SCOPUS citation index (Elsevier, New York, NY) was used. The Joint Commission standards were reviewed, along with the Code of Federal Regulations surrounding the Clinical Laboratories Improvement Amendments of 1988. Specific data were gathered according to the following outline:

  1. 1.

    Number of authors, studies, publications, citations, participants, and represented countries.

  2. 2.

    Highlights of anatomic pathology Q-Probes studies with high impact on the field.

  3. 3.

    Evidence of performance improvement over time.

  4. 4.

    Measures of impact on medicine, including incorporation of data into accreditation requirements, regulatory documents, workshops, presentations, and editorials.

As evidenced by the programming and publication material summarized in Table 2, the anatomic pathology Q-Probes program has had a significant impact on the practice of medicine. Q-Probes studies are referenced directly for many current CAP Laboratory Accreditation Program checklist items and likely play a role in many other regulatory mandates from the Clinical Laboratories Improvement Amendments of 1988, the Joint Commission, the Clinical Laboratory Standards Institute, and other agencies. Q-Probes studies have been the subject of several editorials in Archives of Pathology & Laboratory Medicine and are regularly featured in CAP Today. Perhaps the best indication of the wide-reaching influence of the program is the extent to which Q-Probes information is covered in non-CAP media. Such examples include publications in other highly regarded pathology journals and year books, as well as publications in nonpathology journals and literature from regulatory agencies, including the Joint Commission. Abstracts from Q-Probes studies have been highlighted in Journal of the American Medical Association and are routinely published in pathology journals. Q-Probes studies have also played a prominent role in quality assurance programming for national workshops and courses held by various pathology organizations. The Q-Probes program has led to successful cooperative agreements, including the recent gynecologic cytology consensus conference conducted with cooperation and grant funding of the Centers for Disease Control and Prevention (CDC). Q-Probes studies have also influenced some recently developed proficiency and competency programs offered by the CAP. Finally, a spinoff product from the QPC, Evalumetrics, aids pathologists in complying with the Joint Commission's Ongoing Professional Practice Evaluation/Focused Professional Practice Evaluation initiative.

Table 2. 

Impact of Anatomic Pathology Q-Probes Studies on the Practice of Medicine

Impact of Anatomic Pathology Q-Probes Studies on the Practice of Medicine
Impact of Anatomic Pathology Q-Probes Studies on the Practice of Medicine

The highlights of some salient Q-Probes studies in surgical pathology and cytopathology are summarized in Table 3. Although the QPC has made significant contributions to benchmarks in autopsy pathology, these studies are not summarized because of space constraints. The earliest Q-Probes study was conducted in 1989 by Howanitz and colleagues1  as a pilot and dealt with diagnostic accuracy of frozen section diagnoses. Participants from 34 hospitals examined 1952 frozen section diagnoses from 59 817 accessions or cases in a prospective fashion to determine discordant rates and reasons for discordant diagnoses when compared with the final diagnoses. This study demonstrated an overall discordant rate of 3.5% with a median laboratory discordant rate of 2.6%. Tissue sampling errors and misinterpretations were found to be the most common reason for discordance, each accounting for 29 of the 67 total discordant cases (43%). Fortunately, the effect on patient care was none or minimal in 94% of these cases.

Table 3. 

Highlights of Salient Anatomic Pathology Q-Probes Studies

Highlights of Salient Anatomic Pathology Q-Probes Studies
Highlights of Salient Anatomic Pathology Q-Probes Studies

This study was formally expanded in 1989 to 297 hospitals, and it was well received, with many participants making suggestions for improvement.4  Gephardt and Zarbo16  incorporated these changes into another study in late 1990 and early 1991. The changes included refining the reasons for a discordant diagnosis and inquiring about the pathologic process and anatomic site of the frozen section material. In this study, 90 538 frozen section cases from 461 participating laboratories were examined. Discordant rates were calculated for blocks, specimens, and cases, and discordant rates were corrected for deferred diagnoses, which was not done in the 2 prior studies. The accuracy of frozen section diagnoses was quite high. Based on cases, the uncorrected discordant rates were 2.0% overall, 1.80% for median participants, 4.9% for participants at the 10th percentile, and 0% for participants at the 90th percentile. Similar trends were evident for discordant rates for blocks and specimens (Table 3). Discordant diagnoses were frequently addressed in the final report, 100% median participant. The majority of frozen section discordances occurred because of misinterpretation of the original frozen section (31.8%), the presence of diagnostic tissue in a portion of the specimen not submitted for frozen section (31.4%), and the presence of diagnostic tissue deeper in the block when the frozen section was negative (30.0%).

The frozen section process in pathology was also examined in 1992 and 1993 in a joint study sponsored by the CAP and CDC.9  In this study, pathologists collaborated with surgeons from 472 hospitals to evaluate the indications for pathology intraoperative consultation (PIC) and immediate intraoperative surgical results associated with PIC. Pathologists chose 20 consecutive cases with PIC and queried the attending physician as to reasons for PIC and outcomes based on PIC. In descending order of frequency, the most common reasons for PIC included confirming the diagnosis, assessing the adequacy of margins, assessing the nature of the tissue for triage to other studies, assessing that sufficient tissue was present, and expediting the diagnosis for family. The result of a PIC frequently led to a change in the planned immediate procedure (Table 3). As the authors of this study pointed out, these resultant significant changes to the surgical procedure emphasize the trust that surgeons place in the diagnoses rendered by pathologists.

Not infrequently, the presence of extraneous tissue (ET), also known as floaters or pickups, on a slide may lead to diagnostic uncertainty. One of the more unique Q-Probes studies determined the rates and characteristics of ET present in slides and blocks.19  In a study of 275 laboratories, participants prospectively and retrospectively reviewed slides for ET and features associated with the presence of ET. The prospective part of the study was carried out by pathologists during routine sign-out, lasting for 4 weeks or until 1000 slides were examined. The retrospective part of the study consisted of a second pathologist reviewing 20% of the slides used in the prospective portion of the study. To avoid double counting, the slides that had already been flagged as containing ET during the prospective review were excluded from the retrospective review. At the 50th percentile (Table 3), the prevalence of ET in laboratories was 0.31% of slides in the prospective part of the study and 0.99% in the retrospective part of the study. In the retrospective part of the study, ET tended to be more frequently nonneoplastic and further away from the diagnostic tissue when compared with the prospective part of the study: ET consisted of neoplasm in 12.7% of cases in the prospective part of the study and 6.0% of cases in the retrospective part of the study, and was present close to the diagnostic tissue 59.5% of the time in the prospective portion of the study and 25.3% of the time in the retrospective portion of the study. The fact that the retrospective portion of the study identified higher rates of ET, ET further away from diagnostic tissue, and a greater percentage of nonneoplastic ET was not surprising given the narrow focus of this part of the review, and likely attested to the subconscious filtering of nonneoplastic ET away from diagnostic tissue by pathologists when examining slides for diagnostic purposes.

The degree of diagnostic difficulty engendered by the presence of ET was considered to be severe in 0.4% of slides in the prospective part of the study and in 0.1% of slides in the retrospective part of the study.

Although the overall rates of diagnostic difficulty seem quite low, these are rates at the slide level and are likely to be higher if extrapolated to the number of cases. In more than 90% of events, the ET was thought to have arisen within the pathology laboratory, and to have arisen from a different case 63.2% of the time in the prospective portion of the study and 48.5% of the time in the retrospective portion of the study. The high frequency of ET arising from within a laboratory provides an opportunity to focus interventions within the laboratory. The authors of the study astutely asserted that “higher ET rates probably reflect the overall quality of tissue handling and processing within the laboratory and serve as an indicator of possible serious problems that may lead to inaccurate tissue identification.” 19(p1012)

Review of amended report rates and reasons for amended reports is a useful tool to examine errors in surgical pathology and to provide additional opportunities for focused intervention. A Q-Probes study in 1996 by Nakhleh and Zarbo23  looked at the rates of amended reports in situations that may potentially affect patient care. These areas included patient identification errors, changes in original diagnosis, changes in preliminary diagnosis, and changes to revise other information that was significant to patient management or prognosis. The overall laboratory median rate of amended reports was 1.46 per 1000 cases (10th–90th percentile range, 0.22–4.75 per 1000 cases; Table 3). Specific reasons for amended reports were 19.2% to correct patient identification errors, 38.7% to change the originally issued final diagnosis, 51.6% to alter a preliminary written diagnosis, and 26.5% to modify other relevant clinical information. A physician request to review a case was the most common cause that detected an error resulting in an amended report (20.5%), followed by extradepartmental review instituted by the pathologist (16.1%).

Performance was correlated with different slide review policies. Laboratories in which slides were reviewed prior to finalization of the report had the lowest median rate of amended reports at 1.24 per 1000 cases, compared with median rates of 1.63 per 1000 cases for laboratories with diagnostic slide review after completion of reports and 1.34 per 1000 cases for laboratories with no diagnostic slide review. The authors felt that diagnostic review prior to finalization of the cases was the best practice and one that was likely to maintain patient and clinician confidence with pathology diagnoses. They also found that laboratories that reviewed a set percentage of cases prior to sign-out (9.9% of participants) had the lowest median amended report rate, 0.94 per 1000 cases. Looking more closely at the difference in amended report rates between laboratories with no review policy and those with a retrospective review policy, the authors postulated that the lower rate associated with no review policy reflects a lack of an error detection system, whereas the higher rate associated with retrospective review reflects an ineffective method of error detection. If one does not look for errors, they are less likely to be discovered and prevented.

A 2011 Q-Probes study by Volmar and colleagues46  further investigated surgical pathology report defects/amendments, this time applying a standard taxonomy for defect types. Participants reported a higher defect rate, with a median of 5.7 per 1000 cases (10th–90th percentile range, 13.5–0.9; Table 3). Higher overall rates were reported in laboratories with pathology training programs. Defect fractions were misinterpretation (14.6%), misidentification (13.3%), specimen defect (13.7%), and other defects in nondiagnostic information (58.4%). Lower rates of misidentification were reported in laboratories that conduct pre–sign-out review of all malignancies. The misinterpretation median rate was 0.80 per 1000 cases (10th–90th percentile range, 0.0–2.2; Table 3). Compared with the 1996 study by Nakhleh and Zarbo,23  the proportion of laboratories conducting pre–sign-out review of a set percentage of cases nearly doubled, from to 9.9% 17.6%. This study also provided information for targeted intervention. For example, the skin and breast accounted for the most overall defects and the most misinterpretations, and breast was the most common source of specimen defects.

In a study of 74 institutions in 2003, Raab and colleagues37  also highlighted problems with post–sign-out review of cases to mitigate errors in surgical pathology diagnoses. In this study, participants identified discrepancies from performing secondary review post–sign-out of 100 consecutive cases in either surgical pathology or cytopathology. Cases were identified for review by a variety of means, including review for interdepartmental conferences, physician requests, extradepartmental reviews, and internal quality assurance practices. Discrepancies were defined as any difference between the original diagnosis and the diagnosis after review, and were classified as (1) changes in margin status, (2) change within a diagnostic category (benign to benign or malignant to malignant), (3) changes across diagnostic categories (malignant to benign or benign to malignant), (4) changes in patient information such as a labeling error of the specimen type or location, or (5) typographical errors. Discrepancies were further classified into 3 categories based on patient outcome: harm, near miss, and no harm. The harm category was an event that caused patient injury, such as performance of an improper operation or psychological harm to the patient. The pathologist classified discrepancies in this category as to whether the harm was mild, moderate, or severe to the patient. The category of near miss was defined as one in which the discrepancy was discovered before there was treatment, and the category of no harm indicated no potential injury to the patient. Discrepancies were frequent; the median laboratory discrepancy rate was 5.1%, with 21.0% for laboratories at the 10th percentile and 0% for laboratories at the 90th percentile (Table 3). Changes across diagnostic categories accounted for 21% of all discrepancies, and changes within a diagnostic category accounted for 48% of discrepancies. Although most discrepancies had little or no effect on patient care, 5.3% of all discrepancies had moderate or severe effect on patient care. This reinforces the notion that interventions conducted at post–sign-out review of cases are not entirely effective.

Review of cases prior to sign-out was examined more closely in a Q-Probes study in 2008.41  Participants retrospectively examined 400 cases to identify a maximum of 30 cases reviewed by at least one other pathologist, and documented the organ system, primary disease type, number of additional pathologists consulted, and reason for case review. The median laboratory examined 8.2% of cases prior to sign-out, and those at the 10th and 90th percentile reviewed 2.0% and 17.1% of cases, respectively (Table 3). Most cases came from 4 organ systems: gastrointestinal (20.5%), breast (16.0%), skin (12.7%), and female genital tract (10.0%). One additional pathologist reviewed cases 78% of the time. The most common reasons for review were difficult diagnoses (46.2%) and audits required by departmental policies (43.0%). Most laboratories (71%) had policies regarding review of cases, and laboratories with such policies reviewed about 33% more cases than laboratories without such policies. One limitation of this study is that it is not known what effect case review prior to sign-out had on the actual diagnoses rendered.

Review of cases prior to sign-out is often done because of diagnostic uncertainty. A study in 1998 examined diagnostic uncertainty in prostate needle biopsies.30  A total of 332 participants retrospectively examined the last 50 reports of previously signed out prostate core biopsy cases for up to a period of the previous 2 years. A positive diagnosis indicated the presence of adenocarcinoma in at least one biopsy specimen associated with the case, whereas a negative diagnosis indicated no evidence of adenocarcinoma or uncertainty in any of the specimens associated with the case. The diagnosis of uncertainty was defined as any case that was not clearly positive or negative and that required an additional biopsy to ascertain whether there was malignancy. These diagnoses included but were not limited to such categories as suspicious, consistent with malignancy, consistent with malignancy but not diagnostic, and cannot rule out malignancy. The diagnoses of prostatic intraepithelial neoplasia and carcinoma in situ were also considered uncertain diagnoses but were tabulated separately. As seen from Table 3, the median rate of uncertainty was 6%, with 0% at the 10th percentile and 14% at the 90th percentile. Performing IHC for high-molecular-weight cytokeratin reduced uncertainty in 60% of cases in which it was performed. The largest reductions in diagnostic uncertainty were obtained through intradepartmental consultation (70% reduction) and extradepartmental consultation (87% reduction). This study once again points to the benefit of case review by a second pathologist.

Q-Probes studies have also made significant contributions to the practice of cytopathology by championing the use of benchmarks to monitor and to improve performance. One of the many influential Q-Probes studies in cytopathology quantified and analyzed the correlation between cervical cytology specimens and the corresponding cervical biopsies.14  In this prospective study, 22 439 paired cervical cytology and corresponding cervical biopsy samples were studied from 348 participating laboratories. For discrepant cases, both the biopsy and cytology were reviewed microscopically. Upon review, if a new diagnosis was rendered on the biopsy, that diagnosis was used for correlation, and the error was presumed to be interpretive. If a new diagnosis was rendered on the cytologic smear, the type of cytologic error that was identified was recorded. The error types included screening error, in which the abnormal cells were not identified at the initial time of sign-out, and interpretive error, where the abnormal cells were identified but misclassified.

There was a wide range of performance, as illustrated in Table 3. The median laboratory sensitivity, specificity, and positive predictive value of a Papanicolaou (Pap) test were 92.1%, 61.5%, and 90.9%, respectively. There was a statistically significant inverse correlation between laboratory sensitivity and specificity, indicating that actions taken to increase one would lower the other. Of the positive cytologic diagnoses, the corresponding biopsy correlated more frequently as the severity of the cytologic diagnosis progressed. The overall rate of cytologic-histologic discrepancy was 16.5%. Looking at discrepant cases more closely, the vast majority of paired cytology-biopsy cases were not reclassified upon review, and the discrepancies were attributed to either cytologic sampling or biopsy sampling. In the case of cytology, review of 1444 false-negative smears resulted in 14.7% upgrades to atypical squamous cells of undetermined significance (ASC-US) or worse, and the remaining 86.3% of presumed false-negative smears were likely accounted for by cytology sampling errors. Similarly, review of 1527 false-positive smears resulted in 5.2% downgrades to a negative diagnosis, and the remaining 94.8% of presumed false-positive smears were likely accounted for by biopsy sampling errors.

Human papillomavirus (HPV) testing of Pap tests diagnosed as ASC-US became a standard of care in gynecologic cytopathology in the 1990s. The use of HPV positive rates across many categories of cytologic diagnoses was put forward as a quality assurance metric by several authors, and was the topic of a Q-Probes study by Tworek and colleagues38  in 2005. Laboratories with a low rate of HPV positivity for ASC-US may be overcalling benign Pap tests as atypical, whereas those laboratories with high rates of HPV positivity for ASC-US may be undercalling true dysplasia as ASC-US. The Q-Probes study examined the usefulness of monitoring HPV DNA results in Pap tests diagnosed as ASC-US in 68 laboratories. They found a wide range of positivity, with the median laboratory reporting an HPV positive rate of 46.8%, 18.0% at the 10th percentile, and 64.0% at the 90th percentile. The mean HPV positive rate was 43.74%, with a standard deviation of 17.77%. The standard deviation is so large that only laboratories at the extreme ends of the distribution may be in need of diagnostic fine-tuning, assuming that the laboratories have a sufficient volume of Pap test from a population that is of average risk for HPV infection.

The chance to demonstrate improvement with Q-Probes studies is difficult, as these studies are designed to analyze an issue in depth and are seldom repeated. However, 2 projects of the QPC were repeated, allowing for partial comparison of some performance metrics. The first study was a repeated evaluation of the adequacy of surgical pathology reports for colorectal carcinoma, and the second was a study of compliance with the American Society of Clinical Oncology/CAP guidelines for testing of HER2. A complete surgical pathology report with key elements that conveys essential information to clinicians is important to guide therapy and prognosis. The American College of Surgeons Commission on Cancer, which accredits cancer centers in the United States, requires the inclusion of scientifically validated elements in cancer surgical pathology reports.

In 1991, a Q-Probes study assessed the adequacy of colorectal carcinoma surgical pathology reports, and a follow-up study in 2006 examined the adequacy of surgical reports from colorectal carcinoma in addition to carcinomas from the breast and prostate.6,42  Both studies assessed the presence of key elements in surgical pathology reports. The earlier study used commonly accepted elements that were deemed important before the American College of Surgeons Commission on Cancer guidelines, whereas the later study used elements mandated by the American College of Surgeons Commission on Cancer. Focusing on colorectal carcinomas, there were 3 elements that were common to both studies: histologic grade, margin status, and extent of invasion (Table 4). Histologic grade, margin status, and tumor size were dramatically more prevalent in reports from 2006, whereas there was no change in the prevalence of reporting extent of invasion. Both studies found that the use of checklists for cancer reporting (12.5% and 72.6% of laboratories in 1991 and 2006, respectively) resulted in statistically significant higher rates of completeness or adequacy of cancer reports, and their use may have helped in the improvement of the presence of common elements. However, the use of checklists does not guarantee an adequate surgical pathology cancer report, as 12% of reports in the 2006 study did not have all mandated elements.

Table 4. 

Repeat Anatomic Pathology Q-Probes Studies: Study of Colorectal Surgical Pathology Report Adequacy6,42

Repeat Anatomic Pathology Q-Probes Studies: Study of Colorectal Surgical Pathology Report Adequacy6,42
Repeat Anatomic Pathology Q-Probes Studies: Study of Colorectal Surgical Pathology Report Adequacy6,42

Human epidermal growth factor receptor 2 is an important prognostic marker and therapeutic target for breast cancer. Patients whose breast cancer overexpresses HER2 have a more aggressive clinical course but benefit from trastuzumab, a monoclonal antibody directed against HER2 that has toxic cardiac side effects. Testing for HER2 overexpression is conducted by IHC or fluorescence in situ hybridization. The IHC assay is considered a class II medical device by the U.S. Food and Drug Administration and is subject to guidance documents. In 2007, the American Society of Clinical Oncology/CAP published guidelines55  to standardize and improve the performance and reporting of HER2 results, and in 2008, Nakhleh and colleagues40  surveyed laboratories regarding their compliance with these guidelines. They constructed a questionnaire based on Q-Probes study methodology that was distributed to laboratories participating in the CAP HER2 IHC proficiency test challenge in 2008. Although the performance of laboratories on this survey revealed many opportunities for improvement, the guidelines were relatively new at the time of the 2008 survey; only 25% of laboratories that participated in the survey had been inspected by the CAP with the new guidelines in place. The thought was that perhaps the lack of a full inspection cycle by the CAP may have contributed to the disappointing results by not reinforcing or checking for compliance during the inspection process. The study was repeated in 2011 with the second installment of CAP HER2 IHC proficiency test challenge that year.47  This allowed time for a complete CAP inspection cycle with the American Society of Clinical Oncology/CAP guidelines in place.

Although the authors found statistically significant improvements with some requirements from 2008 to 2011, other parameters showed no improvement. From 2008 to 2011, more laboratories stated the exact fixation time in the report of HER2 (37.9% in 2011 versus 27.2% in 2008) and fewer laboratories did not include any information on the report regarding fixation time (16.8% in 2011 versus 28.4% in 2008). The American Society of Clinical Oncology/CAP guidelines for validation of HER2 IHC require that 25 cases scored as either negative (0–1+) or positive (3+) by IHC be tested either by an alternative method in the same laboratory or by the same method in a second laboratory, and that a 95% concordance rate be achieved.55  Although there were improvements in these variables from 2008 to 2011, there continue to be opportunities for further refinement. The opportunities, as well as a nuanced analysis of these studies, are addressed by one of the authors of the original study as an editorial.54 

Similar to the HER2 study, a survey of IHC validation procedures for nonpredictive assays as well as predictive non–Food and Drug Administration-approved assays was carried out in 2010.45  The survey consisted of 32 questions, and responses were collected from 727 laboratories. In this study, there was a great deal of variability among laboratory validation procedures, reflecting the fact that these analytes are considered class I by the Food and Drug Administration and are not subjected to guidance documents. Table 5 highlights the variability in the number of cases laboratories' written procedures required for validation of both nonpredictive and predictive non–Food and Drug Administration-approved IHC analytes. The number of cases required for validation was greater for predictive markers than for nonpredictive markers. The authors of the study attributed this to the effect that guidelines with HER2 testing and estrogen and progesterone testing may have had on general validation policies. The lower numbers required for nonpredictive markers may reflect a sense of less stringency with these markers or may reflect in some cases a scarcity of material for validation. Scarcity of material for validation was suggested by a trend that smaller laboratories tended to use fewer cases for validation in general, but this was not statistically significant. Scarce tissue also poses a problem in cytologic material, as suggested by the fact that fewer laboratories in the study had written requirements for specifically validating procedures on cytology specimens.

Table 5. 

Recent Direction for Anatomic Pathology Quality Practice Studies: Validation Procedures for Non–U.S. Food and Drug Administration-Approved Immunohistochemistry Assays and Concordance Levels45

Recent Direction for Anatomic Pathology Quality Practice Studies: Validation Procedures for Non–U.S. Food and Drug Administration-Approved Immunohistochemistry Assays and Concordance Levels45
Recent Direction for Anatomic Pathology Quality Practice Studies: Validation Procedures for Non–U.S. Food and Drug Administration-Approved Immunohistochemistry Assays and Concordance Levels45

Although this was not queried in the survey, similar problems with assuring adequate numbers of cases could also be problematic for validating cases undergoing decalcification or for rare diseases/neoplasms. Even if tissue is available, there is no consensus as to the ideal number of cases, the types of cases, and the distribution of staining (positive, negative, or weak positive) that should be tested for validation of nonpredictive IHC assays. Furthermore, there is also a lack of established guidelines for validation of IHC in special processing such as in cytology and in the use of decalcification, nor are there guidelines for the number of cases used for validation of IHC analytes directed against rare tumors.

These problems, highlighted by the study, prompted the inclusion of IHC assay validation into a special structure within the CAP to establish guidelines. The structure known as the CAP Pathology and Laboratory Quality Center (the Center) was established by a collaborative agreement with the CDC and the CAP. The Center employs many tools to establish guidelines, but one of its basic tools is surveys similar to those generated by the QPC to establish current practices. Other topics that the Center will tackle include algorithms for initial workup of acute leukemia, reduction of interpretive diagnostic error through targeted case review, uniform labeling requirements for slides and blocks, bone marrow synoptic reporting, molecular markers for the evaluation of colorectal carcinoma, HER2 testing in gastric cancer, and detection of HPV in head and neck squamous cell carcinoma. The Center offers a concrete way to help improve the practice of pathology and builds off of many of the problems highlighted by Q-Probes studies.

Articles generated by the QPC from anatomic pathology Q-Probes studies have been cited more than 1700 times, and more than 15 000 participants from 18 countries have submitted data to Q-Probes studies in order to benchmark and improve performance. Q-Probes studies are directly cited in CAP Laboratory Accreditation Program checklist items in sections of anatomic pathology, cytopathology, laboratory general, and biorepository. This is a testament to their acceptance as practice standards in anatomic pathology. Q-Probes studies have also likely influenced regulatory mandates from Clinical Laboratories Improvement Amendments of 1988, the Joint Commission, the Clinical Laboratory Standards Institute, and other organizations and governmental agencies. Q-Probes studies have influenced cooperative agreements between the CAP and the CDC to examine practices in gynecologic cytopathology, resulting in a national symposium, the Gynecologic Cytopathology Quality Consensus Conference, and a series of publications on good laboratory practice in gynecologic cytopathology. Q-Probes studies have also influenced the establishment of the Center through a cooperative agreement with the CDC. The Center will lead to establishment of practice guidelines in many facets of anatomic pathology and ensures the continued influence of the QPC on quality programs of the CAP and the field of anatomic pathology. One area of the Center's focus is the reduction of interpretive diagnostic error through targeted review. This is an area that is of particular interest to the QPC, with 4 publications (as summarized in Table 3) that have found targeted review before final sign-out of a case to be an effective way to reduce errors in anatomic pathology.

The body of work in anatomic pathology summarized in Tables 1 and 2 attests to a committee that is productive, curious, and dedicated to improving quality. Although we have labored, it has been a labor of love and allowed us to gather as a group to critically discuss, argue and share our perceptions of quality and to test these perceptions as Q-Probes studies. We have enjoyed these discussions among friends, often in locations where clinical responsibilities were beyond reach for a short while. The many meals shared together and shared experiences of taking side excursions to interesting venues and attractions near our assigned lodging has led to many lifelong friends to whom we have turned to for both professional and personal advice. Many of us have traveled together and have had the good fortune to bring our spouses and children to the QPC meetings, where they were accepted as members of the extended QPC family. The Figure shows a picture of the current QPC committee.

Seated, left to right: Raouf E. Nakhleh, MD, past Quality Practices Committee chair; Joseph A. Tworek, MD, current Quality Practices Committee chair. Back row, left to right: Tracy I. George, MD; Ana K. Stankovic, MD, PhD, MSPH; Liuyan Jiang, MD; Shannon J. McCall, MD; Christine P. Bashleben, MT(ASCP); Anthony J. Guidi, MD; Larry W. Massie, MD; Keith E. Volmar, MD; Glenn E. Ramsey, MD; Rhona J. Souers, MS; Richard W. Brown, MD; Ron B. Schifman, MD; Michael L. Talbert, MD; Barbara J. Blond, MBA, MT(ASCP); Peter L. Perrotta, MD; Roberta L. Zimmerman, MD; Sadia Sayeed, MD; Elizabeth A. Wagar, MD.

Seated, left to right: Raouf E. Nakhleh, MD, past Quality Practices Committee chair; Joseph A. Tworek, MD, current Quality Practices Committee chair. Back row, left to right: Tracy I. George, MD; Ana K. Stankovic, MD, PhD, MSPH; Liuyan Jiang, MD; Shannon J. McCall, MD; Christine P. Bashleben, MT(ASCP); Anthony J. Guidi, MD; Larry W. Massie, MD; Keith E. Volmar, MD; Glenn E. Ramsey, MD; Rhona J. Souers, MS; Richard W. Brown, MD; Ron B. Schifman, MD; Michael L. Talbert, MD; Barbara J. Blond, MBA, MT(ASCP); Peter L. Perrotta, MD; Roberta L. Zimmerman, MD; Sadia Sayeed, MD; Elizabeth A. Wagar, MD.

Close modal

The field of anatomic pathology, like all of medicine, continues to be in great flux because of rapid changes in technology, patient and clinician expectations, and regulations. The QPC, through Q-Probes studies, has made significant contributions to benchmarking and quality improvement in all facets of anatomic pathology, and is positioned to continue to do so in the future. Many of the benchmarking data and examination of practice patterns are in need of reexamination with larger data sets and additional inquiry to identify changes in benchmarks and laboratory practices associated with better performance. In many quality indicators, such as patient identification errors and mislabeling of specimens, we need to move away from benchmarks and toward a near zero tolerance of errors. We need to partner with laboratories to establish best practices to achieve near zero defects in an environment where laboratory financial resources are limited.

The reliance upon a paid subscription base may not be an effective long-term method to fund this work. Nonetheless, this is important work and worthy of continued study. Further collaborative efforts with other CAP committees as well as with the Center may be one paradigm to promote further studies. Obtaining grant support funding similar to that obtained for the symposium on good laboratory practice in gynecologic cytopathology and the Center may be another avenue of revenue, but this too is challenged by decreased government funding.

Decreased financial resources of laboratories will also require new products to leverage automated data collection to decrease full-time equivalents devoted to data collection. Automated data collection will allow for in-depth statistical analysis of a participating laboratory's performance. This will enable QPC to partner directly with individual laboratories or laboratory systems to tailor a quality assurance program to address specific performance issues, test use, and regulatory compliance. Adaptation and flexibility will be key components in the drive of the QPC to keep improving quality assurance in anatomic pathology.

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Author notes

The authors have no relevant financial interest in the products or companies described in this article.