Estrogen Receptor, Progesterone Receptor, and Human Epidermal Growth Factor Receptor 2 Expression Rates in Invasive Breast Carcinoma: A Study of 21 Institutions.

CONTEXT.­: Laboratories performing predictive marker testing for breast carcinoma are encouraged to compare patient results to published benchmarks. OBJECTIVE.­: To collect expression rates for estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) in invasive breast carcinoma from multiple laboratories. DESIGN.­: Participants submitted data from up to 50 primary cases during the study period. Participants reported ER, PgR, and HER2 results in addition to demographic and histologic information. Participants also provided annual institution-level expression rates. RESULTS.­: A total of 21 institutions submitted data for 687 cases. Aggregate positivity rates for ER and PgR were 85.6% and 75.1%, respectively. Receptor positivity rates were higher in well-differentiated (grade 1) tumors (ER, 97.4%; PgR, 88.0%) compared with moderately differentiated (grade 2) tumors (ER, 92.4%; PgR, 84.0%) and poorly differentiated (grade 3) tumors (ER, 61.8%; PgR, 48.0%). Expression rates were higher in postmenopausal women (ER, 87.2%) than premenopausal women (ER, 79.6%) and higher in lobular carcinomas (ER, 98.7%; PgR, 85.3%) than ductal carcinomas (ER, 84.1%; PgR, 74.5%). The aggregate HER2 positivity (score 3+) rate was 9.0%. The aggregate HER2 equivocal (score 2+) rate was 14.5%. Of 81 equivocal (score 2+) cases, 70 (86.4%) were nonamplified. CONCLUSIONS.­: The data from this study provide multi-institutional benchmark data to assist laboratories performing periodic comparisons as part of a quality management program. Overall expression rates were generally similar to those of other published reports, with the exception of the ER-negative and HER2-positive rates, both of which were somewhat lower.

Improving the Customer Experience: Physician Feedback Program for Clinical Laboratories.

CONTEXT.­: Clinician feedback is an important source of information for laboratory quality improvement programs. OBJECTIVE.­: To pilot a program for nearly real-time solicitation and analysis of physician feedback regarding clinical laboratory services. DESIGN.­: Laboratories distributed either electronic or paper survey forms to physicians. Results were tabulated by College of American Pathologists staff. Free-text comments were shared promptly with the participating laboratories to facilitate follow-up. RESULTS.­: Forty-seven clinical laboratories participated in the study and submitted results for 987 physician surveys, including both paper and electronic forms. Of 694 responses submitted electronically within the study period, 460 (66.3%) included at least 1 free-text entry, for a total of 951 free-text comments. CONCLUSIONS.­: Point-of-service solicitation of physician feedback regarding clinical laboratory services is feasible and can provide a substantial quantity of potentially useful information regarding laboratory performance from the customer perspective.

Preanalytic Competency Assessment: A Q-Probes Study Involving 46 Health Care Institutions, 447 Blood Collectors/Phlebotomists, and 2212 Individual Assessments.

CONTEXT.­: Health care organizations face a challenge of assessing preanalytic competency of blood collectors/phlebotomists (BC/Ps). OBJECTIVE.­: To pilot a novel methodology for BC/P preanalytic competency assessment and identify potential areas for improvement. DESIGN.­: Study participants identified preanalytic errors present in 5 blood collection video vignettes. Submitted error descriptions were categorized and then consolidated into a list of standardized required errors for evaluation. RESULTS.­: The correct identification of required error rates across all videos viewed by 447 BC/Ps from 46 institutions ranged from 0.7% to 91.9%. The median phlebotomist score across all 5 videos was 55.9% for 440 eligible blood collectors and ranged between 38.2% (10th percentile) and 70.6% (90th percentile). The median institutional score from 42 eligible institutions was 55.9% (range, 43.3%-65.3% for the 10th to 90th percentiles). There were no significant associations between any laboratory practice characteristics and the institutional average overall phlebotomist scores. The following phlebotomist characteristics were significantly associated with overall phlebotomist scores: level of education (P = .01), having phlebotomy technician (American Society for Clinical Pathology) certification compared with no or other certifications (P = .002), years of experience in collecting blood specimens (P = .01), and higher average number of venipuncture specimens collected per shift (P = .001). CONCLUSIONS.­: Improvement of the awareness and knowledge of correct blood collection practices is needed, because the best performers (90th percentile) did not recognize approximately one-third of the errors. Using hypothetical blood collection scenarios that incorporate performance errors may be a way to assess preanalytic competency of BC/Ps and create opportunities for continuous improvement.

Laboratory Staff Turnover: A College of American Pathologists Q-Probes Study of 23 Clinical Laboratories.

CONTEXT.­: Knowledge of laboratory staff turnover rates are important to laboratory medical directors and hospital administrators who are responsible for ensuring adequate staffing of their clinical laboratories. The current turnover rates for laboratory employees are unknown. OBJECTIVE.­: To determine the 3-year average employee turnover rates for clinical laboratory staff and to survey the types of institutional human resource practices that may be associated with lower turnover rates. DESIGN.­: We collected data from participating laboratories spanning a 3-year period of 2015-2017, which included the number of full-time equivalent (FTE) staff members that their laboratories employed in several personnel and departmental categories, and the number of laboratory staff FTEs who vacated each of those categories that institutions intended to refill. We calculated the 3-year average turnover rates for all laboratory employees, for several personnel categories, and for major laboratory departmental categories, and assessed the potential associations between 3-year average all laboratory staff turnover rates with institutional human resource practices. RESULTS.­: A total of 23 (20 US and 3 international) participating institutions were included in the analysis. Among the 21 participants providing adequate turnover data, the median of the 3-year average turnover rate for all laboratory staff was 16.2%. Among personnel categories, ancillary staff had the lowest median (11.1% among 21 institutions) and phlebotomist staff had the highest median (24.9% among 20 institutions) of the 3-year average turnover rates. Among laboratory departments, microbiology had the lowest median (7.8% among 18 institutions) and anatomic pathology had the highest median (14.3% among 14 institutions) of the 3-year average turnover rates. Laboratories that developed and communicated clear career paths to their employees and that funded external laboratory continuing education activities had significantly lower 3-year average turnover rates than laboratories that did not implement these strategies. CONCLUSIONS.­: Laboratory staff turnover rates among institutions varied widely. Two human resource practices were associated with lower laboratory staff turnover rates.

The Impact of Transit Times on the Detection of Bacterial Pathogens in Blood Cultures: A College of American Pathologists Q-Probes Study of 36 Institutions.

CONTEXT.­: Consolidation of clinical microbiology laboratory services has resulted in extended transit time for blood cultures from service points distant from the laboratory. Sepsis is critical; delays in identification of etiologic agents of diseases could adversely impact patient care. OBJECTIVE.­: To examine the effect of total preanalytic time and blood culture volume on the instrument time-to-detection for bacterial pathogens in blood cultures. A secondary objective was to obtain relevant blood culture information by questionnaire. DESIGN.­: Participants in this Q-Probes study recorded date, time, and volume information for the first 50 positive blood cultures collected during the 12-week study period. Additional information regarding blood culture collection practices was obtained through questionnaire. RESULTS.­: Prolonged overall time-to-detection was secondary to prolonged preanalytic time, particularly prolonged transit time, rather than slower organism growth once bottles were placed on the instrument. Among 1578 blood cultures, the overall time from collection to positive result was significantly less for blood cultures collected on-site than for off-site locations. Most institutions lack sufficient training programs and do not monitor preanalytic time metrics associated with blood cultures. Four hundred fifty-six of the 1580 blood cultures with blood volume adequacy reported (28.9%) were inadequately filled. CONCLUSIONS.­: Overall process time (specimen collection to positive blood culture detection) is predicted to be higher for blood cultures collected off-site. Transit time is a variable that can be reduced to decrease overall time to detection. Thus, improved training and closer attention to preanalytic metrics associated with blood cultures could decrease hospital stays and mortality rates.

Trends in Thyroid Fine-Needle Aspiration Cytology Practices: Results From a College of American Pathologists 2016 Practice Survey.

CONTEXT.­: The College of American Pathologists periodically surveys laboratories to determine changes in cytopathology practices. We report the results of a 2016 survey concerning thyroid fine-needle aspiration (FNA). OBJECTIVE.­: To provide a cross-sectional survey of thyroid cytology practices in 2016. DESIGN.­: In 2016, a survey was sent to 2013 laboratories participating in the College of American Pathologists Non-Gynecologic Cytology Education Program (NGC-A) requesting data from 2015-2016 on several topics relating to thyroid FNA. RESULTS.­: A total of 878 laboratories (43.6% of 2013) replied to the survey. Radiologists performed the most thyroid FNA procedures in most laboratories (70%; 529 of 756), followed by endocrinologists (18.7%; 141 of 756), and most of these were performed under ultrasound guidance (92.1%; 699 of 759). A total of 32.6% of respondents (251 of 769) provided feedback on unsatisfactory rates for nonpathology providers who performed FNA. Intraprocedural adequacy assessment was primarily performed by attending pathologists (77.4%; 490 of 633) or cytotechnologists (28.4%; 180 of 633). Most laboratories used the Bethesda System for Reporting Thyroid Cytopathology (89.8%; 701 of 781) and performed molecular testing based on clinician request (68.1%; 184 of 270) rather than FNA diagnosis. Correlation of thyroid excisions with prior cytology results most often occurred retrospectively (38.4%; 283 of 737) and was used for pathologist interpretive quality assurance purposes. CONCLUSIONS.­: These survey results offer a snapshot of national thyroid FNA cytology practices in 2016 and indicate that standardized cytology terminology is commonly used; pathologists perform most immediate adequacy assessments for thyroid FNA; laboratories use correlation statistics to evaluate pathologists' performance; and molecular tests are increasingly requested for indeterminate interpretations, but reflex molecular testing is rare.

A Q-Probes Study Involving Utilization of Free Prostate-Specific Antigen, Factor V Leiden, and Hepatitis A Serology Tests.

CONTEXT.­: Managing the utilization of laboratory tests is an important quality improvement activity that adds value to health care. OBJECTIVE.­: To examine utilization of 3 laboratory tests and identify factors that impact performance. DESIGN.­: Test utilization performance was evaluated by determining the frequency with which appropriate preconditions for testing were met. This included 30 testing episodes each involving (1) free prostate-specific antigen (PSA) when total PSA was within an appropriate interpretable range, (2) total anti-hepatitis A virus antibody when previous anti-hepatitis A virus antibody results were either negative or not done, and (3) factor V Leiden mutation when a previous result was not already available. Participants also provided information regarding some of their utilization policies and procedures for these 3 tests. RESULTS.­: The overall frequency with which testing criteria were met was 20.6% (163 of 790), 91.5% (649 of 709), and 95.2% (799 of 839) for free PSA, anti-hepatitis A virus antibody, and factor V Leiden, respectively. Utilization review was infrequent and done by 20.7% (6 of 29) of participants for factor V Leiden, 3.6% (1 of 28) for anti-hepatitis A virus antibody, and 3.6% (1 of 28) for free PSA. No practice or demographic characteristics were significantly associated with utilization performance for any test. CONCLUSIONS.­: Utilization review was infrequent for the 3 tests examined. Variable amounts of unnecessary testing were observed for all tests, most frequently for free PSA, for which reporting results carried the added risk of diagnostic error from misinterpretation of results.

Breast Specimen Processing and Reporting With an Emphasis on Margin Evaluation: A College of American Pathologists Survey of 866 Laboratories.

CONTEXT: - The College of American Pathologists (CAP) developed protocols for reporting pathologic characteristics of breast cancer specimens, including margin status. The Society of Surgical Oncology (SSO) and the American Society for Radiation Oncology (ASTRO) published treatment guidelines regarding margins in patients with invasive cancer; and SSO, ASTRO, and the American Society of Clinical Oncology (ASCO) recently published guidelines for patients with ductal carcinoma in situ. OBJECTIVE: - To assess current practices among pathologists with regard to the processing/reporting of breast specimens, assess compliance with CAP cancer protocols, and assess alignment with SSO/ASTRO and SSO/ASTRO/ASCO guidelines. DESIGN: - A survey concerning breast specimen processing/reporting was distributed to pathologists enrolled in the CAP Performance Improvement Program in Surgical Pathology. RESULTS: - Ninety-four percent (716 of 764 respondents) and 91% (699 of 769 respondents) define positive margins as "tumor on ink" for invasive cancer and ductal carcinoma in situ, respectively, in compliance with CAP cancer protocols and with SSO/ASTRO and SSO/ASTRO/ASCO guidelines. Of 791 respondents who provided details regarding methods for margin evaluation, 608 (77%) exclusively examine perpendicular margins, facilitating guideline compliance. However, 183 of 791 respondents (23%) examine en face margins in at least a subset of specimens, which may preclude guideline compliance in some cases. When separate cavity (shave) margins are examined, while 517 of 586 respondents (88%) ink these specimens, 69 of 586 (12%) do not, and this may also preclude guideline compliance in some cases. CONCLUSIONS: - A substantial proportion of survey participants report margin status for breast cancer specimens in a manner consistent with CAP cancer protocols, and in alignment with SSO/ASTRO and SSO/ASTRO/ASCO guidelines. However, there are opportunities for some laboratories to modify procedures in order to facilitate more complete adherence to guidelines.

Professional Practice Evaluation for Pathologists: The Development, Life, and Death of the Evalumetrics Program.

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.