American Society For Clinical Pathology Research Articles

The American Society for Clinical Pathology 2022 Vacancy Survey of medical laboratories in the United States.

To determine the extent and distribution of laboratory workforce shortages within the nation's medical laboratories. The Vacancy Survey was conducted through collaboration between the American Society for Clinical Pathology (ASCP) Institute for Science, Technology and Public Policy in Washington, DC, and the Evaluation, Measurement, and Assessment Department and ASCP Board of Certification in Chicago, IL. Data were collected through an internet survey distributed to individuals who were able to report on staffing and certifications for their laboratories. Results of the ASCP 2022 Vacancy Survey show increased overall vacancy rates for laboratory positions in all departments compared with 2020. Overall retirement rates for laboratory professionals increased across most departments. Current Vacancy Survey data show continued increases in the numbers of laboratory vacancies and retirements as well as changes in certification requirements, with trends amplified during the pandemic continuing into the present. Qualitative analysis results showed that there is an urgent need to focus not only on recruitment but-equally important-on retention of laboratory professionals.

Update on programs for achieving Specialist in Blood Banking certification in the United States: 2023.

A person who has achieved the Specialist in Blood Banking (SBB) certification is a medical laboratory scientist who receives advanced training in blood banking and transfusion medicine and has passed an examination given by the American Society for Clinical Pathology. There are several pathways or "eligibility routes" to qualify for the examination to obtain SBB certification, with the most common route involving enrollment in a Commission on Accreditation of Allied Health Education Programs-accredited SBB program. The goal of this study was to compile information about the current accredited SBB programs in the United States and SBB exam statistics for purposes of assessing changes in the programs and detecting trends in SBB exam takers and pass rates. SBB program coordinators were surveyed about qualitative and quantitative aspects of their programs. Current data, changes over time, and nationally available data were tabulated for comparison. This information may be helpful for all medical laboratory scientists interested in considering further studies and certification in blood banking and transfusion medicine.

Survey of blood collection and transfusion practices among institutions in Africa.

Dramatic improvements in blood transfusion have occurred during the last two decades. Transfusion medicine services and practices in Africa remain underexplored. A survey of blood bank/transfusion medicine (BBTM) practices, available blood products, blood product source(s), pre-transfusion testing, and blood donor infectious disease testing methodologies across Africa was performed using the American Society for Clinical Pathology (ASCP) listserv. Survey recipients included hospital-based laboratories/blood banks, national transfusion medicine services, and free-standing laboratories (collectively referred to as institutions). Responses from a total of 81 institutions across 22 countries were analyzed. All 81 institutions provide at least one type of blood product-whole blood, red blood cells (RBCs), platelets, plasma, and cryoprecipitate, with whole blood (90.1%, 73 of 81) and RBCs (79.0%, 64 of 81) most common, while cryoprecipitate is least common (12.4%, 10 of 81). Only five countries had a responding institution that provides all types of products. Among institutions that collect blood onsite, the most common sources of blood products are patients' family members (94.1%, 48 of 51) and pre-screened on-demand volunteer donors (82.4%, 42 of 51). The most commonly screened infectious agents are HIV and hepatitis B virus (both 81.5%), while 70.4% (57 of 81) test for hepatitis C virus (HCV) and Treponema pallidum. This study highlights significant variability and restrictions in blood product availability, pre-transfusion testing, and blood donor infectious disease testing across Africa. Further studies are needed to ascertain barriers to improving blood donor availability, blood product safety, and infectious disease testing.

Diplomate in Medical Laboratory Immunology Certification Examination: A New Chapter for Medical Laboratory Immunology.

It is indeed a privilege to be an immunologist in what is arguably the golden age of immunology. From astounding advances in fundamental knowledge to groundbreaking immunotherapeutic offerings, immunology has carved out an enviable niche for itself in basic science and clinical medicine. The need and the vital importance of appropriate education, training, and certification in clinical immunology was recognized by the World Health Organization as far back as 1972. In the United States, Ph.D. scientists with board certification in medical laboratory immunology have served as directors of high-complexity Clinical Laboratory Improvement Amendments- and College of American Pathologists-certified clinical immunology laboratories since 1977. From 1977 to 2017, board certification for medical laboratory immunology was administered by the American Society for Microbiology through the American Board of Medical Laboratory Immunology examination. The American Board of Medical Laboratory Immunology examination was phased out in 2017, and in the fall of 2019, the American Society for Clinical Pathology (ASCP) Board of Certification (BOC) examination committee took on the responsibility of developing a new doctoral-level certification examination for medical laboratory immunology. This transition to the ASCP BOC represents a well-deserved and much-needed recognition of the rapid advances in and the highly specialized nature of medical laboratory immunology and its ever-increasing relevance to patient care. This new ASCP BOC certification is called the Diplomate in Medical Laboratory Immunology, and, as of April 1, 2023, it is now available to potential examinees. In this report, we describe the examination, eligibility routes, and potential career pathways for successful diplomates.

The next phase in patient safety education: Towards a standardized, tools-based pathology patient safety curriculum: A call to action from the Association of Pathology Chairs' Residency Program Directors Section Training Residents in Patient Safety Workgroup

Patient safety education is a mandated Common Program Requirement of the Accreditation Council for Graduate Medical Education and for the Royal College of Physicians and Surgeons of Canada in all medical residency and fellowship programs. Although many hospitals and healthcare environments have general patient safety education tools for trainees, few to none focus on the unique training milieu of pathologists, including a mix of highly automated and manual error-prone processes, frequent multiplicity of events, and lack of direct patient relationships for error disclosure. We established a national Association of Pathology Chairs-Program Directors Section Workgroup focused on patient safety education for pathology trainees entitled Training Residents in Patient Safety (TRIPS). TRIPS included diverse representatives from across the United States, as well as representatives from pathology organizations including the American Board of Pathology, the American Society for Clinical Pathology, the United States and Canadian Academy of Pathology, the College of American Pathologists, and the Society to Improve Diagnosis in Medicine. Objectives of the workgroup included developing a standardized patient safety curriculum, designing teaching and assessment tools, and refining them with pilot sites. Here we report the establishment of TRIPS as well as data from national needs assessment of Program Directors across the country, who confirmed the need for a standardized patient safety curriculum.

An Assessment of Gender Equity and Parity Among "Nontraditional" Pathology Awards.

The aim of this study was to assess the gender composition of nontraditional pathology recognition award recipients. Cross-sectional analysis of American Society for Clinical Pathology (ASCP) Top Five40 Under Forty and The Pathologist Power List award recipients' gender. Gender was independently analyzed by 2 authors using pronouns. Two analyses were performed: difference in gender parity and difference in gender equity for award recipients. From 2014 through 2022, 618 total awards were conferred. Significantly more men than women received an award overall (57.1% vs 42.9%; P < .001). Compared with population benchmarks, awards conferred to US-based nontrainee pathology physicians (men 56.2%, women 43.8%; P = .091) and US-based pathology physician trainees (men 60.5%, women 39.5%; P = .15) are equitable. Conversely, gender inequities exist among awards conferred to US-based nonphysician laboratory professionals (men 51.7%, women 48.3%; P < .001). The Pathologist Power List and Top Five ASCP 40 Under Forty awards have not completely achieved gender parity, and gender inequities remain among subgroups.

Abstract P6-04-19: Engaging pathologists in a social peer-to-peer learning collaborative to discuss the emergence of HER2-low breast cancer

Abstract Introduction: Recent advances in research have shown clinical effectiveness when targeting the lower range of HER2 expression (ie, HER2-low) in patients with metastatic breast cancer. American Society for Clinical Pathology worked in collaboration with Q Synthesis to develop a peer-to-peer learning collaborative to proactively prepare pathologists for HER2-low and to discuss the clinical implications around this emerging classification. This CME project was supported by an educational grant from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc. Methods: ASCP launched a peer-to-peer (P2P) learning collaborative (HER2 Breast Trailblazers) where small groups of pathologists met to discuss some of the practical implications associated with HER2-low. 38 pathologists from a mix of academic and community settings participated in this CME program. For foundational knowledge, learners completed online modules covering scientific updates on HER2-low. Through small-group, case-based discussions, learners reviewed operational challenges and opportunities to prepare for HER2-low. They applied this knowledge to lead projects at their own institutions focusing on the anticipated changes around HER2-low. ASCP also launched a series of peer-led Twitter Chats that were designed to reach a broad audience and foster open dialogue about the emerging science of HER2-low breast cancer. This approach engaged Twitter users who were eager to share and disseminate the education to their colleagues. Twitter Chats provided peer-to-peer feedback regarding ways to navigate obstacles, barriers, and other challenges affecting HER2 testing in breast cancer. Results: The learners identified the following challenges and opportunities: Defining HER2-low: Several learners had heard misconceptions around the definition of HER2-low. Recent studies have defined HER2-low as IHC 1+ or IHC 2+ with ISH-negative. Interobserver concordance with IHC 0 vs 1+: Several learners discussed the challenges around interpreting IHC 0 vs 1+. They felt that some pathologists may need guided feedback to improve their diagnostic skills. Use of IHC vs. ISH: Several learners only performed ISH for HER2 testing on all breast cancer samples. If HER2-low emerges as a third category, they would need to return to IHC. Implications for non-metastatic breast cancer: Recent HER2-low studies have focused on patients with metastatic breast cancer. If HER2-low emerges as a third category, it is unclear whether this designation will also be used in patients who have early-stage breast cancer. Leadership: As pathologists prepare for HER2-low, they have opportunities to lead projects to assess and improve IHC interobserver concordance, coach others on IHC interpretation, increase operational efficiency, strength communication skills, and build up the team by proactively anticipating challenges around HER2-low. Conclusions: HER2-low breast cancer appears to be emerging as a new classification and pathologists need to be prepared to ensure accurate testing and interpretation. Through a peer-to-peer learning collaborative, pathologists identified ways to proactively prepare and demonstrate leadership so that cancer centers and laboratories may be ready to embrace a new paradigm of HER2 classification in breast cancer. A series of public Twitter Chats broadened this discussion and increased awareness among pathologists. Citation Format: Joseph Kim, Kellie Beumer, Melissa Kelly. Engaging pathologists in a social peer-to-peer learning collaborative to discuss the emergence of HER2-low breast cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-04-19.

Value of Inpatient Inherited Thrombophilia Testing Following Acute VTE: A 3-Year Retrospective Study

BACKGROUND: Inherited thrombophilia testing following venous thromboembolism (VTE) is of limited utility and, performed in the setting of an acute thrombotic episode, is especially unreliable. Studies suggest that inpatient thrombophilia workups, often performed in the context of acute VTE or stroke, lead to high rates of false positives and can result in inappropriate long-term management decisions. Therefore, various professional societies advise against such testing, especially in acute care settings. These include Choosing Wisely recommendations from the American Society of Hematology, who recommend against routine testing following first episode of provoked VTE, and the American Society for Clinical Pathology, who advise against ordering these tests during an active clotting event. However, these studies continue to be ordered regularly, increasing the overall cost of health care with limited clinical benefit. METHODS: We carried out a retrospective chart review of all inpatient inherited thrombophilia tests ordered between January 1st, 2019 and December 31st, 2021 at Thomas Jefferson University Hospitals, including its 3 primary hospitals in Philadelphia, PA. The goal was to determine indications for testing, rate of positivity, and whether positive results changed patients’ clinical management. Tests included in the study were for the following conditions: Factor V Leiden (FVL); prothrombin G20210A variant (PTG20210A); Protein C, S, and antithrombin deficiency; hyperhomocysteinemia; and plasminogen activator inhibitor-1 (PAI-1) elevation. The study included 152 patients, among whom 574 unique tests were ordered. Tests sent for non-thrombotic indications or in patients with a known factor deficiency were excluded. RESULTS: Patient demographics, clinical presentations, and VTE risk factors are summarized in Table 1. Median age of the patients was 49 years (IQR 34-62) and 53.9% were under age 50. 93 patients (61.2%) were female. VTE was associated with a major transient risk factor or cancer in 44.7% of patients. Conditions for which testing was ordered included FVL (24.7%), PTG20210A (20.4%) Protein S deficiency (16.5%), Protein C deficiency (14.8%), antithrombin deficiency (13.0%), hyperhomocysteinemia (10.3%), and PAI-1 elevation (0.2%). Overall, 81.9% of tests were normal. Among unique tests, MTHFR analysis was most frequently abnormal (71.4% of ordered tests), followed by antithrombin (44.0%), Protein C antigen (27.3%), total Protein S (26.7%), Protein C function (25.7%), and free protein S (20.0%). Certain tests, including antithrombin activity, Protein C antigen and function, and total Protein S, have reference ranges in our lab that start well above 50%, so results that fell below normal but >60% were termed "borderline positive” and considered to be likely false positives. Among individual patients, 62/152 (40.8%) had at least one abnormal result and 47/152 (30.9%) had at least one positive result not considered borderline. There was no significant difference in rate of having at least one non-borderline positive result between patients with unprovoked VTE (27/84, 32.1%) and those with a major transient risk factor, estrogen use/pregnancy, or cancer (20/68, 29.4%; χ2, P=.717). There was also no difference in positive test rate between patients age < 50 years (24/82, 29.3%) and those ≥ 50 years (23/70, 32.9%; P=.633) (Figure 1). All charts were reviewed for inpatient and outpatient documentation to determine short- and long-term clinical decision-making. In 2/152 (1.3%) patients, documentation supported a definitive change in management because of a positive thrombophilia test result. These included a 20-year-old woman with large PE while on a combined oral contraceptive and a 33-year-old man with provoked DVT following severe spinal cord injury (resulting in tetraplegia) who were continued on long-term anticoagulation for Protein S deficiency and double heterozygosity for FVL and PTG20210A, respectively. Based on query of the hospital chargemaster, all tests during the study period totaled $264,913 in charges. CONCLUSION: Our single-institution study found that following acute VTE, inpatient testing for inherited thrombophilias was frequently done in patients with provoked events and resulted in many abnormal tests likely comprising false positives, rarely changed clinical management, and was associated with high costs. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Peripheral Blood Flow Cytometry Outside of Recommended Indications: A Potential Source of Increased Healthcare Costs?

Abstract Introduction/Objective Flow cytometry (FC) is a useful tool in the diagnosis of hematological conditions. Recommended indications for peripheral blood FC have been put forth by several groups, including the American Society for Clinical Pathology (ASCP) in its Choosing Wisely Initiative, and include neutropenia, absolute lymphocytosis, lymphadenopathy and splenomegaly, as well as follow-up for known hematological malignancies. Concerns exist that the use of peripheral blood flow cytometry outside of these indications can be associated with increased health costs. Methods/Case Report We performed a retrospective search for all peripheral blood flow cytometry studies performed at Rush University Medical Center in the period spanning January to June, 2021. We used the Query feature on Soft Computer’s SoftFlow (SCC Soft Computer, Florida). For all cases found the electronic health record was searched for information on the clinical indication, ordering service, history of hematological malignancies, and study results. Results (if a Case Study enter NA) 286 peripheral blood flow cytometry studies were identified, of which 187 had negative findings and 99 were abnormal. 220 cases (77%) were ordered under recommended indications (by ASCP) while 66 cases (23%) were ordered outside of them. Of the studies ordered under recommended indications, 121 (55%) had abnormal findings, while 99 (45%) were negative. Of the studies ordered outside of recommended indications, 100% had negative findings; none of these cases showed a history of hematological malignancy on record. The most common non-recommended indications were isolated anemia (31 cases, 11%), isolated thrombocytopenia (16 cases, 5.5%), bicytopenia (15 cases, 5%) and coagulopathy (4 cases, 1.5%). 42 studies (65%) were ordered by the hematology/oncology service while 22 (35%) were ordered by the internal medicine and surgery services. Conclusion A quarter of the peripheral blood flow cytometry studies in the selected period were performed outside of recommended indications, with negative results in 100% of them. Collectively, single or bicytopenias were the most common non-recommended indication. The majority of these studies were ordered by the hematology/oncology service, with only a third coming from others. Some possible causes for these inappropriate requests include ordering studies as a battery instead of a step-wise approach, and concern for missing an incipient/occult condition.

Engaging Pathologists in a Peer-to-Peer Learning Collaborative on HER2-Low Breast Cancer

Abstract Introduction/Objective Recent advances in research have shown clinical effectiveness when targeting the lower range of HER2 expression (ie, HER2-low) in patients with metastatic breast cancer. American Society for Clinical Pathology worked in collaboration with Q Synthesis to develop a peer-to-peer learning collaborative to proactively prepare pathologists for HER2-low. This CME project was supported by an educational grant from AstraZeneca Pharmaceuticals LP and Daiichi Sankyo Inc. Methods/Case Report 38 pathologists participated in the ASCP HER2 Breast Trailblazers. For foundational knowledge, learners completed online modules covering scientific updates on HER2-low. Through small-group, case- based discussions, learners reviewed operational challenges and opportunities to prepare for HER2-low. They applied this knowledge to lead projects at their own institutions focusing on the anticipated changes around HER2-low. Results (if a Case Study enter NA) The learners identified the following challenges and opportunities: Defining HER2-low: Several learners had heard misconceptions around the definition of HER2-low. Recent studies have defined HER2-low as IHC 1+ or IHC 2+ with ISH-negative. Interobserver concordance with IHC 0 vs 1+: Several learners discussed the challenges around interpreting IHC 0 vs 1+. They felt that some pathologists may need guided feedback to improve their diagnostic skills. Use of IHC vs. ISH: Several learners only performed ISH for HER2 testing on all breast cancer samples. If HER2-low emerges as a third category, they would need to return to IHC. Implications for non-metastatic breast cancer: Recent HER2-low studies have focused on patients with metastatic breast cancer. If HER2-low emerges as a third category, it is unclear whether this designation will also be used in patients who have early-stage breast cancer. Leadership As pathologists prepare for HER2-low, they have opportunities to lead projects to assess and improve IHC interobserver concordance, coach others on IHC interpretation, increase operational efficiency, strength communication skills, and build up the team by proactively anticipating challenges around HER2-low. Conclusion HER2-low breast cancer may be emerging as a new category. Through a peer-to-peer learning collaborative, pathologists identified ways to proactively prepare and demonstrate leadership so that cancer centers and laboratories may be ready to embrace a new paradigm of HER2 classification in breast cancer.

Entry-Level Expectations for Pathologists' Assistants

Abstract Introduction/Objective The aim of this study is to assess expectations for entrustment that exist in the marketplace for entry-level Pathologists’ Assistants (defined as a recent graduate of a Pathologists’ Assistant Program on their first day of employment). Methods/Case Report A voluntary, anonymous survey was distributed to Pathologist and Pathologists’ Assistant (PathA) members of the American Society for Clinical Pathology via email invitation. Ninety-eight professional activities of PathAs were assessed utilizing a five-point scale for levels of entrustment. Demographic information was also collected. Results (if a Case Study enter NA) A total of 728 participants responded to this survey, including 280 Pathologists and 448 PathAs. Responses allowed categorization of activities to one of three groups: activities with an expectation of entrustment for performance (20/98), activities with no expectation of entrustment (30/98), and activities with a developing expectation of entrustment for performance (48/98). Conclusion This study demonstrates that there is an expectation that entry-level PathAs should be entrusted to independently perform only some activities included in the scope of practice, an expectation of developing entrustment for a larger number of professional activities and no expectation for entrustment for certain activities, reflecting more advanced or specialized skills developed during practice.

Leadership Insights From a Pathology Peer-to-Peer Learning Collaborative in Immuno-oncology

Abstract Introduction/Objective As the use of immuno-oncology (IO) expands into more cancers, there is a growing need for pathologists and laboratory professionals to demonstrate leadership and guide biomarker testing processes and procedures at their own institutions. To educate and empower its members, the American Society for Clinical Pathology worked in collaboration with Q Synthesis to develop a peer-to-peer learning collaborative. This project was supported by an educational grant from Bristol Myers Squibb. Methods/Case Report 18 pathologists and laboratory professionals participated in a 10-month program: IO ChangeMakers. Learners completed online modules covering scientific updates on IO biomarker testing. Through small-group, case-based discussions, learners reviewed operational challenges and opportunities to refine biomarker testing. They applied this knowledge to lead IO improvement projects at their own institutions. Results (if a Case Study enter NA) The learners identified the following leadership insights around IO biomarker testing: Reflex testing: Develop or refine reflex biomarker testing processes to ensure that tissue is sent for PD-L1 testing at the time of cancer diagnosis. Establish testing criteria with oncologists and implement steps to reduce delays in testing. Interobserver concordance: Evaluate interobserver concordance among pathologists scoring PD-L1, especially in upper GI cancers where the combined positive score (CPS) is used. Scoring upper GI cancers is challenging because of the spatial distribution of PD-L1 within a tumor. Tissue handling: Identify ways to improve tissue processing and handling to preserve small amounts of tissue for biomarker testing. If quantity is not sufficient, prioritize PD-L1 testing and contact the oncologist to order a liquid biopsy. Confusion around different PD-L1 antibody clones: Pathologists and clinicians are often confused about the use of different PD-L1 antibody clones (eg, 22C3, SP142, etc.) and scoring criteria (eg, TPS ≥ 1%, CPS ≥ 10, TC ≥ 25%, etc.). Develop education and reference guides to ensure the right PD-L1 test is ordered based on the type of tumor and intended treatment. Test ordering to reporting: In many cancer centers, biopsy samples are being sent out for PD-L1 testing. Refine electronic test ordering, tracking status, and reporting results. Conclusion Pathologists have numerous opportunities to lead improvement efforts in IO biomarker testing. As the use of IO expands into more cancers, there will be a growing need for pathologists to demonstrate leadership in this area.

The American Society for Clinical Pathology's 2021 Wage Survey of Medical Laboratories in the United States.

To inform the pathology and laboratory field of the most recent national wage data. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. The 2021 Wage Survey was conducted through collaboration between the American Society for Clinical Pathology (ASCP) Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, IL. Compared with 2019, results show that mean hourly wage for staff-level personnel increased for only two occupations-cytologist and medical laboratory scientist/medical technologist/clinical laboratory scientist-after adjusting for inflation. Geographically, laboratory professionals from urban areas continue to earn more than their rural counterparts. Most respondents reported no change in their salaries during the coronavirus disease 2019 pandemic. The pandemic had a significant effect on staffing, workload, and work-life balance of many laboratory professionals. Even with the salary increases reported from the results of this survey, it is evident that the increases have not kept up with the current inflation. Focus on visibility, recruitment and retention, and diversity are essential to develop long- and short-term solutions.

Empowering pathologists to lead immuno-oncology (IO) biomarker testing in the community.

348 Background: As the landscape of immuno-oncology (IO) expands, there is a growing need to improve biomarker testing processes in the community. To educate and empower pathologists to lead in this area, the American Society for Clinical Pathology (ASCP) worked in collaboration with Q Synthesis to develop a peer-to-peer learning collaborative. This project was supported by an educational grant from Bristol Myers Squibb. Methods: ASCP recruited a group of 18 pathologists and laboratory professionals who made the commitment to participate in a 10-month program called IO ChangeMakers. Learners completed online modules covering scientific updates on IO biomarker testing. They went into small groups for case study discussions and reviewed operational challenges and opportunities to refine biomarker testing. Learners applied this knowledge to lead IO improvement projects at their own institutions. Results: Learners led improvement projects that addressed the following: Reflex testing: Several developed or refined reflex biomarker testing processes to ensure that tissue was sent for PD-L1 testing at the time of cancer diagnosis. Pathologists established testing criteria with oncologists and implemented steps to reduce delays in testing. Interobserver concordance: One learner identified a need to study interobserver concordance among pathologists diagnosing upper GI cancers and scoring PD-L1 using the combined positive score (CPS). After scanning over 100 gastric cancer slides, different pathologists were asked to provide CPS scoring on the digital images. Results from this study are still pending. Tissue handling: Several identified ways to improve tissue processing and handling to preserve small amounts of tissue for biomarker testing. In cases where the quantity was not sufficient, pathologists asked the lab to prioritize PD-L1 testing and asked oncologists to order a liquid biopsy to look for molecular biomarkers. Confusion around different PD-L1 antibody clones: Several aimed to reduce confusion regarding different PD-L1 antibody clones (eg, 22C3, SP142, etc.) and scoring criteria (eg, TPS ≥ 1%, CPS ≥ 10, TC ≥ 25%, etc.). They developed reference guides and education for staff to ensure that oncologists would order the right type of PD-L1 test based on the type of tumor, stage of disease, and intended treatment. Test ordering to reporting: Most worked in hospitals where samples were sent out for PD-L1 testing. The use of different electronic systems (health record, lab information system) resulted in multiple inefficiencies when tests were ordered. They found ways to improve electronic test ordering, tracking status, and reporting results. Conclusions: Pathologists can be empowered to lead improvement efforts in biomarker testing. As the use of IO expands into more cancers, there will be a growing need for more pathologists to demonstrate leadership in this area.

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

Health care organizations face a challenge of assessing preanalytic competency of blood collectors/phlebotomists (BC/Ps). To pilot a novel methodology for BC/P preanalytic competency assessment and identify potential areas for improvement. 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. 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). 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.

Entry-Level Expectations for Pathologists' Assistants.

The aim of this study was to assess expectations of performance that exist in the marketplace for entry-level pathologists' assistants (PathAs), defined as recent graduates of a pathologists' assistant program on their first day of employment. A voluntary, anonymous survey was distributed to pathologist and PathA members of the American Society for Clinical Pathology by email. We assessed 98 professional activities of PathAs using a 5-point scale of expectations based on levels of trust placed in them. We also collected demographic information. A total of 728 participants responded to this survey, including 280 pathologists and 448 PathAs. We classified 98 activities according to expectations: independent performance (20/98), developing independence (48/98), and not expected of PathAs (5/98). Some activities (25/98) were indeterminate yet likely represent areas of developing independence. This study demonstrates an expectation for entry-level PathAs to perform some activities included in the scope of practice independently but eventually to develop independent proficiency for most professional activities. A minority of activities were identified as responsibilities that are not expected of PathAs. Entry-level PathAs, therefore, remain "works in progress," with an expectation for independent performance of core activities while developing abilities in many areas of professional practice.

The American Society for Clinical Pathology 2020 Vacancy Survey of Medical Laboratories in the United States.

To determine the extent and distribution of workforce shortages within the nation's medical laboratories. The survey was conducted through collaboration between the American Society for Clinical Pathology Institute for Science, Technology, and Public Policy in Washington, DC, and the Evaluation, Measurement, and Assessment Department and Board of Certification in Chicago, IL. Data were collected via an internet survey distributed to individuals who were able to report on staffing and certifications for their laboratories. The coronavirus disease 2019 (COVID-19) pandemic disrupted the staffing of clinical laboratories and the stream of incoming graduates entering the workforce. Results show decreased vacancy rates for the majority of laboratory positions across all departments surveyed. The overall anticipated retirement rates continue to decline, which suggests that the field has already lost personnel with vast amounts of experience. Addressing the current and future needs of the laboratory workforce requires a collective effort by numerous groups of stakeholders at all levels, including the laboratory employers, laboratory training programs, health care executives/hospital administrators, and professional organizations. The time is now to address the future shortage of laboratory professionals and to create a resilient clinical laboratory professional workforce.

American Gastroenterological Association Institute and College of American Pathologists Quality Measure Development for Detection of Mismatch Repair Deficiency and Lynch Syndrome Management

American Gastroenterological Association Institute and College of American Pathologists Quality Measure Development for Detection of Mismatch Repair Deficiency and Lynch Syndrome Management

An assessment of the United States Preventive Services Task Force cervical cancer screening guidelines

<h3>Objectives:</h3> United States Preventive Services Task Force (USPSTF) screening guidelines are widely used to establish standards of care. There are gaps, however, in the study populations on which the 2018 USPSTF cervical cancer screening guidelines are based. The purpose of this study is to: 1) conduct a systematic review of the studies that comprise these guidelines, focusing on high risk United States (US) populations as defined by self-identified race or ethnicity, age ≥65, and insurance status, 2) analyze the generalizability of the guidelines to high risk US populations. <h3>Methods:</h3> We accessed the USPSTF 2018 Cervical Cancer screening guidelines and the evidence summary and reviewed the seven randomized control trials (RCTs), four cohort studies, and one cross-sectional analysis that provided the evidence for these recommendations. We identified demographic data specific to self-identified race or ethnicity, age ≥65, and insurance status. Additionally, we reviewed the latest cervical cancer screening guidelines published by the National Comprehensive Cancer Network (NCCN), American Society for Colposcopy & Cervical Pathology (ASCCP), American College of Obstetrics & Gynecology (ACOG), American Society for Clinical Pathology (ASCP), and the American Cancer Society (ACS). Finally, in August 2020, we searched PubMed for RCTs, meta-analyses, clinical trials, systematic reviews from 2015-2020, focusing on our pre-identified demographic data. <h3>Results:</h3> Two of the 14 studies used as the basis for the 2018 USPSTF cervical cancer screening include race or ethnicity data (Table 1). Of these two studies, one was a US-based cohort study and the other a cross-sectional study from the United Kingdom (Table 1). None of the RCTs used for the USPSTF guidelines included race or ethnicity. All seven RCTs were conducted in countries with less racial diversity than the US, except for Canada (Table 1). Four studies included participants age ≥65. Eleven of the 14 studies were conducted in countries with some form of universal health care coverage. Of the non-USP-STF organizations, the 2019 ASCCP guidelines used three cohorts that included majority White participants, low-income patients, and individuals age ≥65. Of the 629 PubMed articles reviewed, 18 studies suggested that the application of current cervical cancer screening guidelines to high risk populations may lead to underscreening and delay in diagnosis. <h3>Conclusions:</h3> While the screening guidelines from USPSTF and non-USPSTF organizations discuss the existence of broad disparities in cervical cancer screening, few of the studies used to comprise these guidelines specifically include high risk populations in the US as defined by self-identified race or ethnicity, age ≥65, insurance status. In addition, the generalizability of these guidelines to a US population remains limited given the participant demographics enrolled in the studies that comprise these guidelines.

Strengthening Pathology Capacity to Deliver Quality Cancer Care in Cities in LMICs.

Diagnostic pathology services for oncology health systems are essential; yet, surveys, observations, and hard data from across low- and middle-income countries have revealed that these services are almost always lacking adequate quality and often missing completely. The City Cancer Challenge Foundation (C/Can), the American Society for Clinical Pathology, and C/Can partner cities undertook intense analysis of their existing pathology services as part of a year-long assessment process including the specific formation of a pathology-focused team. Internal and external expert assessments identified sustainable solutions adapted to the local context and level of resources and created specific local implementation projects. Through local leadership, capacity development, and collaboration, services were improved city-wide in three cities: Cali, Colombia; Asunción, Paraguay; and Yangon, Myanmar. Common problems identified across cities included deficiencies in personnel training, equipment, reagents, processes, quality, and coordination. Specific solutions included quality training, standard process development and regulation, implementation of new services, and public-private collaboration. As the first cities joining the C/Can initiative, Cali, Asunción, and Yangon demonstrate the success of the approach and the value of local expertise in identifying problems and solutions. The additional value of international partners' expertise created opportunities for growth through mentorship and technical support. Importantly, the power of healthcare programs with strong political support is emphasized.