Operational Impacts of the Coronavirus Disease 2019 (COVID-19) Pandemic and Early Recovery Trends: University of Washington Anatomic Pathology Experience.

CONTEXT.­: The coronavirus disease 2019 pandemic, caused by the novel coronavirus severe acute respiratory syndrome coronavirus 2, has resulted in worldwide disruption to the delivery of patient care. The Seattle, Washington metropolitan area was one of the first in the United States affected by the pandemic. As a result, the anatomic pathology services at the University of Washington experienced significant changes in operational volumes early in the pandemic. OBJECTIVE.­: To assess the impact of coronavirus disease 2019 and both state and institutional policies implemented to mitigate viral transmission (including institutional policies on nonurgent procedures) on anatomic pathology volumes. DESIGN.­: Accessioned specimens from January to June 2020 were evaluated as coronavirus disease 2019 and institutional policies changed. The data were considered in these contexts: subspecialty, billable Current Procedural Terminology codes, and intraoperative consultation. Comparable data were retrieved from 2019 as a historical control. RESULTS.­: There was a significant reduction in overall accessioned volume (up to 79%) from prepandemic levels during bans on nonurgent procedures when compared with 2020 pre-coronavirus disease 2019 volumes and historical controls. The gastrointestinal and dermatopathology services were most impacted, and breast and combined head and neck/pulmonary services were least impacted. Current Procedural Terminology code 88305, for smaller/biopsy specimens, had a 63% reduction during nonurgent procedure bans. After all bans on procedures were lifted, the overall volume plateaued at 89% of prepandemic levels. CONCLUSIONS.­: A significant decrease in specimen volume was most strongly associated with bans on nonurgent procedures. Although all departmental areas had a decrease in volume, the extent of change varied across subspecialty and specimen types. Even with removal of all bans, service volume did not reach prepandemic levels.

Indiscriminate Pathologic Examination of Pediatric Supraglottoplasty Specimens: An Evidence-Based Approach toward Exempt Status.

OBJECTIVE: The primary aim of this study was to demonstrate that indiscriminate pathologic evaluation of supraglottoplasty specimens is unnecessary and does not influence postoperative management. The secondary objective was to determine the costs associated with pathologic evaluation of supraglottoplasty specimens. METHODS: A planned chart review was conducted to evaluate data from consecutive patients undergoing supraglottoplasty. Demographic data were extracted and pathology reports were reviewed. Projected cost savings were estimated based on 2018 Centers for Medicare & Medicaid Services reimbursement rates for Current Procedural Terminology code 88304 (surgical pathology, gross and microscopic examination). RESULTS: A total of 1417 consecutive patients were identified. All specimens underwent gross and microscopic examination. Pathologic outcomes were categorized into 3 major categories: no diagnostic abnormality (n = 1069), chronic inflammation (n = 346), and other (n = 2). Pathologic evaluation did not alter postoperative management in any patient. Projected yearly and 5-year cost- savings totaled $11,818.08 and $59,173.92, respectively. DISCUSSION: These findings demonstrate that pathologic examination of supraglottoplasty specimens adds no value to patient management. A more selective approach to pathologic examination of certain surgical specimens is an improvement opportunity to enhance the value of patient care by eliminating direct financial costs and "hidden costs" associated with unnecessarily increased workload. IMPLICATIONS FOR PRACTICE: Addressing inappropriate, indiscriminate pathologic examination of certain surgical specimens is a potential quality improvement opportunity that has a meaningful impact on the value of patient care and reduces strains on the workload of surgical and pathology department personnel.

Implementation of Digital Pathology Offers Clinical and Operational Increase in Efficiency and Cost Savings.

CONTEXT.­: Digital pathology (DP) implementations vary in scale, based on aims of intended operation. Few laboratories have completed a full-scale DP implementation, which may be due to high overhead costs that disrupt the traditional pathology workflow. Neither standardized criteria nor benchmark data have yet been published showing practical return on investment after implementing a DP platform. OBJECTIVE.­: To provide benchmark data and practical metrics to support operational efficiency and cost savings in a large academic center. DESIGN.­: Metrics reviewed include archived pathology asset retrieval; ancillary test request for recurrent/metastatic disease; cost analysis and turnaround time (TAT); and DP experience survey. RESULTS.­: Glass slide requests from the department slide archive and an off-site surgery center showed a 93% and 97% decrease, respectively. Ancillary immunohistochemical orders, compared in 2014 (52%)-before whole slide images (WSIs) were available in the laboratory information system-and 2017 (21%) showed $114 000/y in anticipated savings. Comprehensive comparative cost analysis showed a 5-year $1.3 million savings. Surgical resection cases with prior WSIs showed a 1-day decrease in TAT. A DP experience survey showed 80% of respondents agreed WSIs improved their clinical sign-out experience. CONCLUSIONS.­: Implementing a DP operation showed a noteworthy increase in efficiency and operational utility. Digital pathology deployments and operations may be gauged by the following metrics: number of glass slide requests as WSIs become available, decrease in confirmatory testing for patients with metastatic/recurrent disease, long-term decrease in off-site pathology asset costs, and faster TAT. Other departments may use our benchmark data and metrics to enhance patient care and demonstrate return on investment to justify adoption of DP.

Assessing the Value of Routine Pathologic Examination of Resected Femoral Head Specimens After Femoral Neck Fracture.

INTRODUCTION: The purpose of this study was to evaluate the efficacy of routine pathologic examination (PE) of femoral head (FH) specimens after arthroplasty for acute femoral neck fractures and to determine the cost. METHODS: This was a retrospective chart review of 850 acute femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty These were evaluated to determine whether the FH was sent for PE, the resultant findings, alterations in medical treatment, and cost. RESULTS: A total of 466 FH specimens (54.8%) were sent to pathology. Four (0.9%) were positive for a neoplastic process. All four had a known history of cancer, antecedent hip pain, or an inappropriate injury mechanism. None of the findings resulted in an alteration in medical treatment. The average cost of PE was $195 USD. DISCUSSION: The routine PE of FH specimens after arthroplasty for femoral neck fractures is not warranted and uneconomic. Sending the FH for PE, only when clinically indicated, rather than routine, will result in notable savings for the healthcare system. LEVEL OF EVIDENCE: Level IV.

See, Test & Treat: A 5-Year Experience of Pathologists Driving Cervical and Breast Cancer Screening to Underserved and Underinsured Populations.

CONTEXT: - See, Test & Treat is a pathologist-driven program to provide cervical and breast cancer screening to underserved and underinsured patient populations. This program is largely funded by the CAP Foundation (College of American Pathologists, Northfield, Illinois) and is a collaborative effort among several medical specialties united to address gaps in the current health care system. OBJECTIVE: - To provide an outline for administering a See, Test & Treat program, using an academic medical center as a model for providing care and collating the results of 5 years of data on the See, Test & Treat program's findings. DESIGN: - Sources include data from patients seen at Tufts Medical Center (Boston, Massachusetts) who presented to the See, Test & Treat program and institutional data between 2010 and 2014 detailing the outline of how to organize and operationalize a volunteer cancer-screening program. RESULTS: - During the 5-year course of the program, 203 women were provided free cervical and breast cancer screening. Of the 169 patients who obtained Papanicolaou screening, 36 (21.3%) had abnormal Papanicolaou tests. In addition, 16 of 130 patients (12.3%) who underwent mammography had abnormal findings. CONCLUSIONS: - In general, women from ethnic populations have barriers that prevent them from participating in cancer screening. However, the CAP Foundation's See, Test & Treat program is designed to reduce those barriers for these women by providing care that addresses cultural, financial, and practical issues. Although screening programs are helpful in identifying those who need further treatment, obtaining further treatment for these patients continues to be a challenge.

The Impact on Endoscopic Resource Utilization After a Targeted Intervention for Cost-Minimization of EGD and Colonoscopy.

OBJECTIVES: The need to define the cost of endoscopic procedures becomes increasingly important in an era of providing low-cost, high-quality care. We examined the impact of informing endoscopists of the cost of accessories and pathology specimens as a cost-minimization strategy. METHODS: We conducted a prospective observational cohort study of therapeutic outpatient esophagogastroduodenoscopy (EGD) and colonoscopy. During the pre-intervention phase (phase 1), the endoscopists were not briefed on the cost of accessories or pathology specimens obtained during the procedure. During a 3-week intervention phase and the post-intervention phase (phase 2) endoscopists were informed of the dollar value of accessories and pathology specimens after the completion of all procedures. In all cases the institutional costs (not charges) were used. The endoscopists were blinded to their observation. RESULTS: A total of 969 EGD, colonoscopy, and EGD+colonoscopy performed by 6 endoscopists were reviewed, 456 procedures in phase 1 and 513 procedures in phase 2. There was no significant difference between phases 1 and 2 in total device and pathology cost in dollars (188.8±151.4 vs. 188.9±151.8, P=0.99), total device cost (36.2±107.9 vs. 39.0±95.96, P=0.67) and total pathology cost (152.6±101.3 vs. 149.9±112.5, P=0.70). There was not a significant difference in total device and pathology cost when examined by specific procedures performed, or for any of the endoscopists between phases 1 and 2. CONCLUSIONS: Making endoscopists more cost conscious by informing them of the costs of each procedure during EGD and colonoscopy does not result in lower procedural costs. Analysis of cost-minimization strategies involving procedures in other health-care settings and procedures using high-cost accessories are warranted.

Impact of Recent Developments in Lung Cancer on the Practice of Pathology.

Landmark events in the field of lung cancer in the past year have the potential to significantly alter the practice of pathology. Three key events are (1) approval of payment for low-dose computed tomography screening for lung cancer, (2) publication of an extensively revised World Health Organization classification of lung cancers, and (3) approval of immunohistochemistry based companion diagnostics by the US Food and Drug Administration. We briefly review these milestones in the context of their impact on the practice of pathology.

Laboratory Test Utilization Management: General Principles and Applications in Hematopathology.

As the cost of health care continues to rise and reimbursement rates decrease, there is a growing demand and need to cut overall costs, enhance quality of services, and maintain as a top priority the needs and safety of the patient. In this article, we provide an introduction to test utilization and outline a general approach to creating an efficient, cost-effective test utilization strategy. We also present and discuss 2 test utilization algorithms that are evidence-based and may be of clinical utility as we move toward the future of doing the necessary tests at the right time.

Patient preferences of a resect and discard paradigm.

BACKGROUND: Resect and discard is a new paradigm for management of diminutive polyps. It is unknown whether patients will embrace this new paradigm in which small polyps would not be sent for histopathologic review. OBJECTIVE: To determine whether patients would be willing to pay for pathology costs with their own money and which factors influence patients' decisions to pay or not pay for pathology costs with their own money. DESIGN: Single-center, prospective, survey study. SETTING: Hospital outpatient endoscopy center. PATIENTS: Adults undergoing colonoscopy for screening or routine polyp surveillance. INTERVENTIONS: Patient survey. MAIN OUTCOME MEASUREMENTS: Willingness to pay out-of-pocket for pathology costs when a diminutive polyp is found and factors that influence patients' decisions to pay or not pay for pathology costs with their own money. RESULTS: A total of 500 participants completed the survey. A total of 360 respondents (71.9%) indicated a hypothetical willingness to pay out-of-pocket for histopathologic polyp analysis if this interpretation was not covered by insurance. Patient factors significantly associated with willingness to pay for polyp analysis included higher income and education and female sex. LIMITATIONS: Single center, hypothetical situation. CONCLUSION: Over two-thirds of patients were willing to pay to have their diminutive polyp sent for pathologic evaluation if their insurance carrier would not pay the cost. Factors associated with willingness to pay included higher income, higher education, and female sex. Patients who were unwilling to pay raised concerns about cost and are less concerned about cancer risk compared with those willing to pay. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT02305251.).

Wide-field computational imaging of pathology slides using lens-free on-chip microscopy.

Optical examination of microscale features in pathology slides is one of the gold standards to diagnose disease. However, the use of conventional light microscopes is partially limited owing to their relatively high cost, bulkiness of lens-based optics, small field of view (FOV), and requirements for lateral scanning and three-dimensional (3D) focus adjustment. We illustrate the performance of a computational lens-free, holographic on-chip microscope that uses the transport-of-intensity equation, multi-height iterative phase retrieval, and rotational field transformations to perform wide-FOV imaging of pathology samples with comparable image quality to a traditional transmission lens-based microscope. The holographically reconstructed image can be digitally focused at any depth within the object FOV (after image capture) without the need for mechanical focus adjustment and is also digitally corrected for artifacts arising from uncontrolled tilting and height variations between the sample and sensor planes. Using this lens-free on-chip microscope, we successfully imaged invasive carcinoma cells within human breast sections, Papanicolaou smears revealing a high-grade squamous intraepithelial lesion, and sickle cell anemia blood smears over a FOV of 20.5 mm(2). The resulting wide-field lens-free images had sufficient image resolution and contrast for clinical evaluation, as demonstrated by a pathologist's blinded diagnosis of breast cancer tissue samples, achieving an overall accuracy of ~99%. By providing high-resolution images of large-area pathology samples with 3D digital focus adjustment, lens-free on-chip microscopy can be useful in resource-limited and point-of-care settings.

Remote and rapid pathological diagnosis in a resource challenged unit.

Malawi is one of the world's poorest countries, but despite this, has a dedicated paediatric oncology service. The service has been hampered by the inability to make a timely cytological diagnosis in the majority of patients. A telemedicine programme was commenced to help overcome this problem, and the results for the first 197 consecutive patients are described. The results are compared with the local reports where available. Most samples were fine needle aspirates (104/197-53%), but others included bone marrow aspirates, peripheral blood films and other fluid collections. A diagnosis was arrived at in 52% of the samples; there were 46 discordant results, 38 were when one or other of the local or distant teams were unable to make a diagnosis, and only 8 where the diagnoses of the 2 teams differed. Diagnoses were made and reports were compiled by the 'distant' team within 24 h and sent to the centre in Malawi. This simple telepathology initiative has had a positive impact on clinical management, and could be used in other less resourced centres twinned with better resourced ones.

Utility of additional tissue sections in dermatopathology: diagnostic, clinical and financial implications.

BACKGROUND: As histopathologic assessment is subject to sampling error, some institutions 'preorder' deeper sections on some or all cases (hereafter referred to as prospective deeper sections), while others order additional sections only when needed (hereafter referred to as retrospective deeper sections). We investigated how often additional sections changed a diagnosis and/or clinical management. Given the recent decrease in reimbursement for CPT-code 88305, we also considered the financial implications of ordering additional sections. METHODS: Cases (n = 204) were assigned a preliminary diagnosis, based on review of the initial slide, and a final diagnosis, after reviewing additional sections. Cases with discordant diagnoses were assessed by two dermatologists, who indicated whether the change in diagnosis altered clinical management. Expenses were estimated for three scenarios: (a) no additional sections, (b) prospective deeper sections and (c) retrospective deeper sections. RESULTS: Diagnoses were modified in 9% of cases, which changed clinical management in 56% of these cases. Lesions obtained by punch-biopsy and inflammatory lesions were disproportionately overrepresented amongst cases with changed diagnoses (p < 0.001, p = 0.12, respectively). The cost of prospective deeper sections and retrospective deeper sections represented a 56% and 115% increase over base costs, respectively. Labor costs, particularly the cost of dermatopathologist evaluation, were the most significant cost-drivers. CONCLUSIONS: While additional sections improve diagnostic accuracy, they delay turn-around-time and increase expenditures. In our practice, prospective deeper sections are cost effective, however, this may vary by institution.

[Laboratory management fee in national health insurance; what is required from clinical laboratory physicians? --message from Chairpersons].

The laboratory management fee (LMF) in national health insurance ("Kentai-Kensa-Kanri-Kasan" in Japanese) has had a major impact on Japanese clinical laboratories, especially in recent years. In 2012, the fee was raised to approximately 5,000 yen per admitted patient. In order to address this national support, clinical pathologists are required to increase their knowledge and skills. On the other hand, there are insufficient clinical pathologists in Japan. In order to solve this problem, the Japanese Society of Laboratory Medicine (JSLM) approved a new license for Qualified Clinical Laboratory Managing Physicians (CLMPs), in addition to Certified Clinical Laboratory Physicians (CCLPs). The requirements to become a CLMP are less strict than for CCLP. There are approximately 500 CLMPs and 600 CCLPs in this country. The aim of this symposium was to offer opportunities to increase attendees' clinical skills, especially CLMPs and young clinical pathologists. Four CCLPs were chosen as speakers from a university hospital, a major city hospital, a medium-sized acute care hospital, and a university hospital anatomical pathologist, together with a chief medical technologist from a university hospital. All the speakers presented their ideal role models of clinical pathologists matching LMF requirements. JSLM together with the Japanese Association of Clinical Laboratory Physicians (JACLaP) sponsored this symposium. It was a successful meeting with more than two hundred attendees.

[Problems to be solved to qualify to receive laboratory examination management fee III or IV for board-certified doctors in the fields of both laboratory medicine and anatomical pathology].

At least one full-time doctor in laboratory management and consultation on data analysis is required to receive laboratory examination management fee III or IV according to the rules for Japanese public health insurance medical fees. A qualified pathologist, board-certified as a clinical laboratory physician cannot receive this fee together with the pathological diagnosis management fee even if he or she manages laboratory examinations. As a result of this regulation, surgical pathologists working in laboratory examinations are gradually decreasing in Japan; however, it is possible for surgical pathologists working as full-time attending physicians in the Department of Laboratory Medicine to receive the laboratory examination management fee. Consultation regarding laboratory data analysis is required, and experience in diagnostic pathology is beneficial for data interpretation or tissue sample handling in the field of neoplastic diseases.

Activity-based costing for pathology examinations and comparison with the current pricing system in Turkey.

OBJECTIVE: To demonstrate the real cost data of the pathology examinations by using the activity-based costing method and to contribute to the financial planning of the departments, health managers and also the social security institution. MATERIAL AND METHOD: Forty-four examinations selected from the Healthcare Implementation Notification system list and performed at the Ankara University Faculty of Medicine Pathology Department during September 2010 were studied. The analysis and the real cost calculations were done according to the duration of the procedures. Calculated costs were compared with the Healthcare Implementation Notification system and Medicare price lists. RESULTS: The costs of the pathology tests listed within the same pricing levels in the Healthcare Implementation Notification system list showed great differences. The minimum and maximum costs in level 1, 2, 3, and 4 were 15,98-80,15 TL, 15,95-258,59 TL, 42,38- 236,87 TL, and 124,42-406,76 TL, respectively. Medicare price levels were more consistent with the real costs of the examinations compared to the Healthcare Implementation Notification system price list. CONCLUSION: The prices of the pathology examination listed at different levels in the Healthcare Implementation Notification system lists do not cover the real costs of the work done. The principal parameters of Activity-Based Costing system are more suitable for making the most realistic cost categorization. Although the prices could differ between countries, the Medicare system categories are more realistic than the Healthcare Implementation Notification system. The Healthcare Implementation Notification system list needs to be revised in order to reflect the real costs of the pathology examinations.

Use of a United States-based laboratory as a hematopathology reference center for a developing country: logistics and results.

INTRODUCTION: With proper logistical support and sponsorship, a laboratory in an industrialized nation might be able to act as a reference laboratory for clinicians based in a developing country. METHODS: We built on previous experience in the clinical laboratory to see whether a specialized histopathology service (hematopathology) could be provided to a developing country without the expertise or experience to do it in country. RESULTS: Over an 13-year period, 582 cases from 579 individuals were analyzed. Principal pathologic findings included acute leukemia in 84 cases (14%), dyspoiesis in one or more of the hematopoietic lineages in 65 cases (11%, including three cases with high-grade myelodysplasia), 23 cases (4%) with findings suspicious for a chronic myeloproliferative disorder, 35 cases (6%) with findings suspicious for a lymphoproliferative disorder, and infectious organisms (presumably Leishmania in most instances) in 9 (1%) of cases. Specimens from 45 cases (8%) were unsatisfactory owing to extreme hemodilution and/or specimen degeneration. CONCLUSION: With proper support, a medical laboratory in an industrialized nation may serve as a reference facility for a developing nation. The use of existing infrastructure may be remarkably effective to achieve optimal turnaround time. Although the lack of ancillary studies and follow-up biopsies limit the ability to achieve a definitive diagnosis in many cases, this must be viewed in the context of the limited ability to diagnose or manage hematopoietic neoplasia in developing nations.

Value-added benefits and utilization of pathologists' assistants.

CONTEXT: The role of pathologists' assistants (PAs) in terms of surgical and autopsy prosection has been well established; however, the role of PAs in areas beyond surgical and autopsy pathology, such as laboratory administration and management, education, and research, is not so well understood. OBJECTIVE: To determine the scope and extent of ancillary duties (value-added benefits) performed by PAs. DESIGN: A self-administered, electronic survey was disseminated to all members of the American Association of Pathologists' Assistants with fellowship status to analyze the ancillary duties PAs provide in laboratory administration and management, education, and research. RESULTS: Respondents were from 44 states and most had 6 or more years of experience in various work settings: community hospitals (50%), academic hospitals (30%), private pathology laboratories (15%), and "other" settings (5%). Most were involved in quality assurance programs (64.0%), laboratory accreditation inspections (56.2%), and a large percentage (44.4%) also had direct supervisory experience. Roughly 36% of respondents reported training residents in prosection skills in a clinical setting, while a small percentage reported teaching for-credit courses in a classroom setting (4.9%). The primary research responsibility was fresh tissue procurement for tumor banking (52.7%). CONCLUSIONS: Pathologists' assistants currently are involved in ancillary duties beyond surgical and autopsy prosection. Our findings indicate that PAs have a desire to become more involved in these duties, and there is opportunity for pathologists to benefit further by using PAs to the full extent of their knowledge, skills, and interests.

Can a gastrointestinal pathologist identify microsatellite instability in colorectal cancer with reproducibility and a high degree of specificity?

Clinical features usually initiate evaluation for Lynch Syndrome (LS) but some colorectal cancer (CRC) histopathology findings are compatible with high microsatellite instability (MSI-H) that also occurs in LS. This led to the suggestion that pathologists request MSI analysis, which is an expensive addition to routine histology. We aimed to see if a Gastrointestinal Pathologist could identify MSI-H features with reproducibility and high (95%) specificity (MSI-H 95%). Histopathology of all CRCs received during 2005 and 4 MSI-H controls were scored using 2 published methods, "MsScore" and "PathScore". MSI analysis was performed on CRCs scored by either method as probable MSI-H 95% and results compared. To examine reproducibility of histopathology, 100 coded slides, including 25 scored MSI-H 95% and 75 scored low, were re-examined to now identify those needing MSI analysis. Costs were evaluated for identifying MSI-H with or without scoring. All 227 CRCs were scored for possible MSI-H 95%; 24 had high scores and MSI analysis. DNA analysis proved 14 MSI-H, PathScore identified 13 (95%), MsPath identified 9 (64%), histopathology alone identified 7 (50%). Reproducibility for identifying histopathology characteristics of MSI-H at re-examination, without scoring, was "moderate agreement" (Kappa statistic = 0.4615). Costs for identifying MSI-H by PathScore were the lowest, $436/identification. Conclusions; PathScore identified the most proven MSI-H CRCs at lowest cost and even an experienced gastrointestinal pathologist has difficulties identify MSI-H without scoring. So, scoring can be facilitated by a computerized evaluation form for routine CRC histology, prompting score computation and recommendation for MSI analysis with high specificity.