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The United States Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) established minimum requirements for assuring the quality of laboratory testing in US clinical laboratories. (1) To ensure accurate diagnosis [...], * Context.--To date, the College of American Pathologists (CAP) has developed 17 laboratory practice guidelines (LPGs) including updates. In 2013, the CAP was awarded a 5-year cooperative agreement grant from the United States Centers for Disease Control and Prevention to increase the effectiveness of LPGs. Objective.--To assess the awareness and adoption of 2 CAP LPGs: immunohistochemical (IHC) assay validation and initial workup of acute leukemia. Design.--Baseline surveys for each LPG were conducted in 2010 and 2015, respectively. To measure the adoption of guideline recommendations and inform future updates, a follow-up study consisting of surveys, telephone interviews, and focus group sessions was conducted in laboratories that indicated they perform IHC testing. A follow-up study for the acute leukemia LPG is planned. Results.--For the IHC Validation LPG, a total of 1624 survey responses, 40 telephone interviews, and discussions with 5 focus group participants were analyzed. The response rate for the aforementioned 3 modalities was 46%, 13%, and 3%, respectively. All modalities indicated most respondents were aware of the LPG and had adopted most or all of its recommendations. Respondents expressed needs for continued communication, increased specificity, and more prescriptive recommendations when the guideline is updated. Conclusions.--While data-driven development of evidence-based LPGs requires significant resources, active data collection to identify gaps and assess adoption contributes to improved laboratory testing practices in support of patient care. The CAP identified sustainable modalities to track metrics and developed multiple tools that should improve guideline development, adoption, and implementation. Of these modalities, written or electronic surveys were the most logistically feasible and had the highest response rate. (Arch Pathol Lab Med. 2020;144:83-89; doi: 10.5858/arpa.2018-0276-CP)

The College of American Pathologists (CAP) Pathology and Laboratory Quality Center (the CAP Center) develops and maintains evidence-based laboratory practice guidelines (LPGs) that follow the US Institute of Medicine's Clinical [...], Context.--Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation. Objective.--To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline. Design.--A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing. The results were compared with an earlier survey of validation practices. Results.--Analysis was based on responses from 1085 laboratories that perform immunohistochemical staining. Of 1057 responses, 65.4% (691) were aware of the guideline recommendations before this survey was sent and 79.9% (550 of 688) of those have already adopted some or all of the recommendations. Compared with the 2010 survey, a significant number of laboratories now have written validation procedures for both predictive and nonpredictive marker assays and specifications for the minimum numbers of cases needed for validation. There was also significant improvement in compliance with validation requirements, with 99% (100 of 102) having validated their most recently introduced predictive marker assay, compared with 74.9% (326 of 435) in 2010. The difficulty in finding validation cases for rare antigens and resource limitations were cited as the biggest challenges in implementing the guideline. Conclusions.--Dissemination of the 2014 evidencebased guideline validation practices had a positive impact on laboratory performance; some or all of the recommendations have been adopted by nearly 80% of respondents. (Arch Pathol Lab Med. 2017;141:1247-1254; doi: 10.5858/arpa.2016-0558-CP)

The cancer protocols developed and maintained by the College of American Pathologists (CAP) have become de facto clinical guidelines for the appropriate reporting of pathologic features necessary for the treatment [...]

In 2015, the College of American Pathologists (CAP) conducted a survey of laboratory practices to examine the current state of immunohistochemical assay (IHC) validation procedures, assess general awareness of the [...], Context.--A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. Objective.--To establish new benchmark data on IHC laboratory practices. Design.--A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional non subscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. Results.--The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for non-predictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for non-predictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. Conclusions.--Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations. (Arch Pathol Lab Med. 2017;141:1255-1261; doi: 10.5858/arpa.2016-0559-CP)

The 2016 revision to the World Health Organization (WHO) classification of acute leukemia (AL) illustrates the increasing complexity driving the classification of AL. (1) The classification includes 23 subtypes of [...], Context.--The classification and prognosis determination in acute leukemia (AL) are complex and it is unclear what testing is being performed in practice. Objective.--To survey physicians describing their current practice of test ordering in the diagnosis of AL. Design.--In anticipation of a guideline by the College of American Pathologists (CAP) and the American Society for Hematology on laboratory testing needed for the initial workup of Al, a baseline survey was designed by an expert panel from CAP. Members of professional societies were asked to describe their current practice of test ordering. Results.--Two hundred ninety-four responses were received with 258 respondents analyzed after the first qualifying survey question regarding initial diagnosis of AL. One hundred seventy-six of 249 respondents (70.7%) were board-certified hematopathologists. Flow cytometry and karyotype analysis were routinely performed for acute myeloid leukemia (AML) (99.1% [232 of 234] and 96.2% [225 of 234], respectively) and acute lymphoblastic leukemia (ALL) (98.3% [229 of 233] and 96.6% [225 of 233], respectively). In addition, fluorescence in situ hybridization studies were routinely performed by 81.2% (190 of 234) of respondents for AML and 85.0% (198 of 233) of respondents for ALL; other molecular studies were performed by 78.2% (183) for AML and 54.9% (128) for ALL; immunohistochemistry by 44.9% (105) for AML and 47.6% (111) for ALL; and cytochemistry by 24.8% (58) for AML and 14.2% (33) for ALL. Conclusions.--While flow cytometry and karyotyping are routinely reported as being performed for the diagnosis of AL, there is marked variation in the reporting of testing patterns for other genetic studies, immunohistochemistry, and cytochemistry. (Arch Pathol Lab Med. 2017;141:1101-1106; doi: 10.5858/arpa.2016-0398-CP)

In 2008, the Joint Commission (JC) implemented a new standard mandating evaluation of practitioners' professional performance as part of the process of granting and maintaining practice privileges in a health [...], Context.--In 2008, the Joint Commission (JC) implemented a standard mandating formal monitoring of physician professional performance as part of the process of granting and maintaining practice privileges. Objective.--To create a pathology-specific management tool to aid pathologists in constructing a professional practice-monitoring program, thereby meeting the JC mandate. Design.--A total of 105 College of American Pathologists (CAP)-defined metrics were created. Metrics were based on the job descriptions of pathologists' duties in the laboratory, and metric development was aided by experience from the Q-Probes and Q-Tracks programs. The program was offered in a Web-based format, allowing secure data entry, customization of metrics, and central data collection for future benchmarking. Results.--The program was live for 3 years, with 347 pathologists subscribed from 61 practices (median, 4 per institution; range, 1-35). Subscribers used 93 of the CAP defined metrics and created 109 custom metrics. The median number of CAP-defined metrics used per pathologist was 5 (range, 1-43), and the median custom-defined metrics per pathologist was 2 (range, 1-5). Most frequently, 1 to 3 metrics were monitored (42.7%), with 20% each following 4 to 6 metrics, 5 to 9 metrics, or greater than 10 metrics. Anatomic pathology metrics were used more commonly than clinical pathology metrics. Owing to low registration, the program was discontinued in 2016. Conclusions.--Through careful vetting of metrics it was possible to develop a pathologist-specific management tool to address the JC mandate. While this initial product failed, valuable metrics were developed and implementation knowledge was gained that may be used to address new regulatory requirements for emerging value-based payment systems. (Arch Pathol Lab Med. 2017; 141:551-558; doi: 10.5858/arpa.2016-0275-CP)

Surgical pathology cases are frequently sent for consultation to other institutions. Typically, extradepartmental consultations are sought to resolve diagnostic uncertainty or to obtain input on a case from an expert. [...], Objectives.--To document the practice parameters and case characteristics associated with personal (expert) consultations. We also examine the value, level of participant (customer) satisfaction, turnaround time, and rate of personal consultations. Design.--We asked participants in the College of American Pathologists' Q-Probes program to document cases sent for consultation during 4 months or up to 20 cases. They documented patient and specimen characteristics, the turnaround times, and the participants' levels of satisfaction with the consultation experience. Participants.--One hundred eighty laboratories/surgical pathology practices. One hundred seventy-two (95.6%) were from the United States; the remainder were located in Canada and Australia. Main Outcome Measures.--Rate and turnaround time of consultations and participant level of satisfaction. Results.--A total of 2746 consultation cases were examined for an aggregate consultation rate of 0.5% (median, 0.7%). Institutions with a higher occupied bed size and a greater number of surgical pathology cases both had lower consultation rates (P ≤ .05). The median turnaround time (defined as the interval from the date on which the case was sent to the date on which the diagnosis was received) was 6 days. Twenty-nine percent and 68% of cases had a turnaround time within 3 and 7 days, respectively. Fifty-two percent of cases were sent to nationally known experts, and 32% were sent to local experts. Skin (18.0%), hematolymphoid (11.6%), and breast (9.6%) specimens were most commonly sent for consultation. In 70.5% of cases, the consultant confirmed the referring pathologist's original diagnosis, but in 15.9% of cases, the consultant also added significant information. Satisfaction rates were higher with faster turnaround times and verbal reporting. Satisfaction rates were lower for cases in which the patient or the clinician requested the consultation and in which the consultant's diagnosis was ambiguous. Conclusions.--This study establishes a multi-institutional consultation rate of 0.5%, defines the nature of surgical pathology consultations, and demonstrates that satisfaction with consultations is associated with a faster turnaround time and receipt of additional, clinically meaningful information.

The test cycle in surgical pathology and cytology is similar to the test cycle of other laboratory tests. (1-4) It is composed of the preanalytic, analytic, and postanalytic phases. The [...], Context.--Additional reviews of diagnostic surgical and cytology cases have been shown to detect diagnostic discrepancies. Objective.--To develop, through a systematic review of the literature, recommendations for the review of pathology cases to detect or prevent interpretive diagnostic errors. Design.--The College of American Pathologists Pathology and Laboratory Quality Center in association with the Association of Directors of Anatomic and Surgical Pathology convened an expert panel to develop an evidence-based guideline to help define the role of case reviews in surgical pathology and cytology. A literature search was conducted to gather data on the review of cases in surgical pathology and cytology. Results.--The panel drafted 5 recommendations, with strong agreement from open comment period participants ranging from 87% to 93%. The recommendations are: (1) anatomic pathologists should develop procedures for the review of selected pathology cases to detect disagreements and potential interpretive errors; (2) anatomic pathologists should perform case reviews in a timely manner to avoid having a negative impact on patient care; (3) anatomic pathologists should have documented case review procedures that are relevant to their practice setting; (4) anatomic pathologists should continuously monitor and document the results of case reviews; and (5) if pathology case reviews show poor agreement within a defined case type, anatomic pathologists should take steps to improve agreement. Conclusions.--Evidence exists that case reviews detect errors; therefore, the expert panel recommends that anatomic pathologists develop procedures for the review of pathology cases to detect disagreements and potential interpretive errors, in order to improve the quality of patient care. (Arch Pathol Lab Med. 2016; 140:29-40; doi: 10.5858/arpa.2014-0511-SA)

With the rapid growth of specialized ancillary testing, laboratories are frequently asked to use anatomic pathology material to perform molecular testing. Such testing may be conducted either in-house or as [...], Context.--The appropriate and timely performance of molecular testing in anatomic pathology is an indicator of quality. The National Comprehensive Cancer Network (NCCN) publishes a comprehensive treatment guideline that includes recommendations for ancillary testing. Objective.--To establish benchmarks for rates of adherence to NCCN testing recommendations through a multi-institutional study. Design.--Participants in a 2013 Q-Probes study of the College of American Pathologists reported data from molecular testing on anatomic pathology cases, excluding hematolymphoid neoplasms, breast primary carcinomas, and gynecologic cytology. Results.--Twenty-six institutions reported data from 2230 molecular testing events. In a retrospective study limited to colon, lung, and melanoma, there was strict adherence to guidelines in a median 71% (10th to 90th percentile range, 33%-90%) and there was at least loose adherence in a median 95% (10th to 90th percentile range, 57%-100%). There was adequate tissue to complete testing in a median 98% (10th to 90th percentile range, 86%-100%); in aggregate the adequacy rate for cell blocks was lower (84%, P < .001). Median test turnaround time was 8 days (10th to 90th percentile range, 4-13 days). In a prospective collection of all organ sites, there was strict adherence to guidelines in a median 53% (10th to 90th percentile range, 20%-71%), and there was at least loose adherence in a median 94% (10th to 90th percentile range, 75%-100%). Adherence to guidelines was higher for lung specimens and in institutions with more multidisciplinary conferences. Conclusions.--This multi-institutional study provides benchmarking data on appropriateness and timeliness of molecular testing in anatomic pathology. (Arch Pathol Lab Med. 2015;139:1115-1124; doi: 10.5858/arpa.2014-0513-CP)

Since the publication of the Institute of Medicine report on medical errors in 1999 there has been a flurry of activity to try to improve medicine. (1) Because of the [...]

Clinical laboratory testing is a production system that turns inputs--orders for tests, patient identifiers, and specimens--in relevant cycle times, usually referred to as turnaround times (TATs), into outputs--reporting events, some [...], Context.--Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring. Objective.--To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors. Design.--Subscribers measured monthly rates of outpatient order-entry errors, identification band defects, and specimen rejections; median troponin order-to-report cycle times and rates of STAT test receipt-to-report turnaround time outliers; and critical values reporting event defects, and corrected reports. From these submissions Q-Tracks program staff produced quarterly and annual reports. These charted each subscriber&apos;s performance relative to other participating laboratories and aggregate and subgroup performance over time, dividing participants into best and median performers and performers with the most room to improve. Each monitor&apos;s patterns of change present percentile distributions of subscribers&apos; performance in relation to monitoring durations and numbers of participating subscribers. Changes over time in defect frequencies and the cycle duration quantify effects on performance of monitor participation. Results.--All monitors showed significant decreases in defect rates as the 7 monitors ran variously for 6, 6, 7,11, 12,13, and 13 years. The most striking decreases occurred among performers who initially had the most room to improve and among subscribers who participated the longest. All 7 monitors registered significant improvement. Participation effects improved between 0.85% and 5.1% per quarter of participation. Conclusions.--Using statistical quality measures, collecting data monthly, and receiving reports quarterly and yearly, subscribers to a comparative monitoring program documented significant decreases in defect rates and shortening of a cycle time for 6 to 13 years in all 7 ongoing clinical laboratory quality monitors. (Arch Pathol Lab Med. 2015; 139:762-775; doi: 10.5858/arpa.2014-0090-CP)

Transplantation of pancreatic islets, or the portion of the pancreas that releases insulin, may be as effective as transplantation of the entire pancreas for treating patients with insulin-dependent diabetes mellitus. This type of transplantation may reduce the need for injected insulin in these patients. Five patients between 12 and 37 years old who had their pancreas removed to treat pancreatitis underwent transplantation of pancreatic islets from their own pancreas. All five patients were able to survive without injected insulin for one to seven-and-a-half years after pancreatic islet transplantation. Patients who received at least 265,000 islets had normal blood levels of glucose (sugar) during fasting and of hemoglobin A for up to seven years after transplantation. Release of insulin and glucagon occurred at the proper times, but lower levels were released than in healthy individuals.

Abstract Background Inferior vena cava (IVC) leiomyosarcoma is a rare tumor of smooth muscle origin. It is often large by the time of diagnosis and may involve adjacent organs. A margin-free resection may be curative, but the resection must involve the tumor en bloc with the affected segment of vena cava and locally involved organs. IVC resection often requires vascular reconstruction, which can be done with prosthetic graft. Case presentation We describe a 39-year-old man with an IVC leiomyosarcoma that involved the adrenal gland, distal pancreas, and blood supply to the spleen and left kidney. Tumor excision involved en bloc resection of all involved organs with reimplantation of the right renal vein and reconstruction of the IVC with a polytetrafluoroethylene graft. The patient recovered without renal insufficiency, graft infection, or other complications. Follow-up abdominal imaging at 1 year showed a patent IVC graft and no locally recurrent tumor. Prosthetic graft provides a sufficient diameter and length for replacement conduit in extensive resection of IVC leiomyosarcoma. Conclusion To our knowledge, this is the first case of resection of an IVC sarcoma with prosthetic graft reconstruction in combination with pancreatic resection. Aggressive surgical resection including vascular reconstruction is warranted for select IVC tumors to achieve a potentially curative outcome.

Along with diagnostic accuracy and report completeness, turnaround time (TAT) in surgical pathology has been the focus of various studies, surveys, and quality improvement programs. (1-9) Report TAT is a [...], Context.--Turnaround time (TAT) for large or complex surgical pathology specimens is an indicator of efficiency in anatomic pathology and may affect coordination of patient care. Objective.--To establish benchmarks for TAT and to identify practice characteristics that may influence TAT. Design.--Participants in a 2012 Q-Probes quality improvement program of the College of American Pathologists retrospectively reviewed all surgical pathology cases from the prior 6 months to identify up to 50 cases coded as Current Procedural Terminology (CPT) code 88307 (excluding biopsies) or 88309. Participants reported the times and dates of accessioning and final sign-out. Results.--A total of 56 institutions reported on 2763 large or complex cases, which included 70% with CPT code 88307 and 30% with CPT code 88309. Cases requiring special handling comprised 51.5%, and 48.5% were routine. Among all institutions the median TAT was 2.72 calendar days (10th-90th percentile range, 6.23-1.22 days). Longer tAt occurred in governmental institutions (median, 6.06 versus 2.13 days; P < .001) and in institutions that mandate overnight fixation for some specimen types (median, 3.83 versus 2.07 days; P = .03). Longer TAT was associated with CPT code 88309 (median, 3.99 versus 2.82 days; P < .001), special handling (median, 4.13 versus 1.94 days; P < .001), frozen section (median, 3.38 versus 2.92 days; P < .001), radical cancer resection (P < .001), and malignant cases (P < .001). Turnaround time was not significantly affected by either pathology training programs or routine weekend sign-out. Conclusions.--This study provides benchmark data for TAT in large or complex surgical pathology specimens. Turnaround time was good overall, but the range among participating institutions was wide. (Arch Pathol Lab Med. 2015; 139:171-177; doi: 10.5858/arpa.2013-0671-CP)