On-site Adequacy Research Articles

Utility of Endoscopic Ultrasound-Guided Fine-Needle Aspiration in a Paediatric Population: A Single-Centre Experience

Introduction: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a modern and minimally invasive technique to acquire diagnostic material from within the gastrointestinal tract, as well as from adjacent organs and structures, which can help in the diagnosis and staging of a variety of gastrointestinal malignancies, as well as for non-malignant conditions. Though well described in adults, there is limited literature on the diagnostic utility of EUS-FNA in paediatric patients. The objective of this study was to evaluate the diagnostic accuracy and clinical utility of EUS-FNA in paediatric patients performed at our centre over the last 17 years. Materials and Methods: After obtaining Institutional Review Board approval, 63 cases of paediatric EUS-FNA performed at SKMCH&RC from 2005 to 2022 were retrieved. A 22-gauge EUS-FNA needle was used for obtaining samples with the use of suction (when required). The sample was then smeared onto glass slides, with half being stained with RAPI stain while the rest with the Papanicolaou stain. Demographic details, indication for the procedure, results of rapid on-site adequacy status (ROSE), site of lesion, and cytological diagnosis were reviewed and analysed. Results: Of the 63 patients, 55 (87.3%) had an adequate sample (confirmed on ROSE). Forty-two (66.7%) were male and the mean age was 12.4 years. The most frequent indication of EUS-FNA was a sampling of enlarged lymph nodes (74.6%). The most common sites of nodal aspiration were sub-carinal (33.3%) and celiac lymph nodes (14.3%). EUS-FNA of a pancreatic lesion accounted for an additional 17.5% of cases. Involvement by Hodgkin’s lymphoma was the most common diagnosis (25.4%) followed by granulomatous inflammation (19.1%). Cases of solid pseudo-papillary tumour (4.8%) and recurrent Wilm’s tumour (3.2%) were also diagnosed. No patient suffered complications, and none required hospital admission, post-procedure. The sensitivity, specificity, PPV, and NPV of EUS-FNA were 98.1, 83.3, 96.4, and 90.9%, respectively. Conclusion: EUS-FNA is a safe, well-tolerated, minimally invasive outpatient setting procedure with high sensitivity and significant utility in the diagnosis and staging of disease.

Diagnostic significance of clay-like materials aspirated from thyroid nodules.

The simplest way to determine the adequacy of aspirated materials is the on-site gross visual assessment of aspirated materials. However, few studies have examined the gross findings of thyroid aspirates. This study aimed to clarify the diagnostic significance of clay-like material aspirated from thyroid nodules. We reviewed 69,848 thyroid nodules that underwent aspiration cytology at Kuma Hospital between January 2007 and August 2021. Among them, 355 (0.5%) nodules with aspirated materials described as clay-like materials were retrospectively examined. Among 355 nodules, 322 (90.7%) were categorized as cystic fluid or benign. The aspirated materials were mainly composed of non-epithelial components, including colloid or proteinaceous materials, foamy histiocytes, and degenerative red blood cells. In original ultrasound reports, the incidence of intermediate and high suspicion was 11.0%. Malignant cells were observed in 21 nodules (5.9%), one-third of which were papillary thyroid carcinomas. The materials aspirated from papillary and follicular thyroid carcinomas exhibited necrotic carcinoma cells derived from infarcted areas. The overall risk of malignancy was 3.9%. The risk of malignancy in nodules interpreted as highly suspicious on ultrasound examination was 37.5%. As clay-like materials aspirated from thyroid nodules were considered sufficient specimens, the recognition contributes to avoiding unnecessary second punctures. The presence of clay-like materials was indicative of the colloid and/or blood components of benign cystic lesions, or, more rarely, of infarcted carcinoma. The ultrasound examination results tended to overestimate nodules. We should reaffirm that on-site gross visual assessment of aspirated materials is a fast and reasonably accurate predictor of the on-site adequacy of the samples.

Audit of diagnostic cytology of ultrasound-guided fine-needle aspiration with and without rapid on-site adequacy assessment in a lower-income country

Audit of diagnostic cytology of ultrasound-guided fine-needle aspiration with and without rapid on-site adequacy assessment in a lower-income country

The yield and impact of pulmonologist-performedEUS-B-FNA of subdiaphragmatic lesions-an institutional experience.

Pulmonologists can biopsy structures below the diaphragm using the convex curvilinear ultrasound bronchoscope via the esophagus (EUS-B). The literature with respect to the value of EUS-B, rapid on-site evaluation, and final diagnostic yield for structures below the diaphragm is limited. We review our institutional experience. Our database was queried retrospectively for EUS-B fine needle aspirations (FNAs) from 2013 to 2021. All procedures involving EUS-B-FNA of subdiaphragmatic structures were selected for analysis. The following data elements were collected for each patient: age, gender, clinical indication, sample site, on-site adequacy (OSA), preliminary and final diagnoses, and sufficiency of cell block for ancillary studies. A total of 75 subdiaphragmatic sites were biopsied in 74 patients. Of which, 87% of samples subjected to rapid on-site evaluation were deemed to contain adequate material (OSA+). There were no false-positive OSAs. Six cases remained nondiagnostic at the final diagnosis. The final diagnostic yield (with cell block) was 92% (69/75 cases). Cell block was sufficient for immunohistochemistry or special stains in all applicable cases (n = 36). Molecular testing was requested for 11 cases and successful in 10 (91%). Sampling of subdiaphragmatic sites changed the stage in 67% (38/57) of lung cancer patients. Pulmonologists can perform EUS-B-FNA of subdiaphragmatic sites with high OSA and final diagnostic yield when assisted by cytopathologists. Strong correlations exist between OSA, cell block adequacy, and subsequent capacity to perform ancillary testing. EUS-B below the diaphragm can make an important contribution to the diagnosis of lung cancer, nonpulmonary malignancies, and other diseases.

Reducing non diagnostic thyroid cytology using on-site adequacy assessment performed by junior medical staff

Objective:To assess efficacy of bedside cytology assessment of thyroid fine needle aspirate samples performed by junior medical staff compared to cytologists. Methods: Retrospective analysis was performed of 1490 thyroid fine needle aspirates. Samples were divided into three groups: cellular adequacy assessment performed by cytologists, interns, and no onsite adequacy assessment (blind). A 45-minute training session was provided to medical interns with the aim of identifying whether adequate cellular material was demonstrated, as defined by the Bethesda criteria. The primary outcome was the rate of nondiagnostic samples, and the secondary outcome was the number of fine needle aspirate passes required to reach sample adequacy. Results: The incidence of non-diagnostic samples for the cytologist, blind, and intern groups were 6.90%, 17.1% and 14.0% respectively (p<0.001). There was no statistically significant difference in non-diagnostic rate between the blind and intern groups. Significantly more aspirates required more than two passes in the cytologist group (74.8%) and blind (94.7%) compared to the intern group (58.7%, p<0.001). Conclusions: On-site adequacy assessment performed by cytopathologists is the gold standard for minimising non-diagnostic thyroid FNAs, however, medical staff with minimal anatomical pathology experience can be trained to perform on-site adequacy assessment and improve outcomes with the implementation of a simple targeted training program.

On-Site Adequacy in Pulmonologist-Performed EUS-B-FNA of Subdiaphragmatic Lesions – An Institutional Experience

On-Site Adequacy in Pulmonologist-Performed EUS-B-FNA of Subdiaphragmatic Lesions – An Institutional Experience

The current practice of telecytology for rapid on-site evaluation (ROSE): Practical considerations and limitations.

Advances in digital imaging technology and development of high-speed internet has brought a change in ROSE practice from the traditional in-person to remote evaluation. The rapid expansion of image-guided procedures to obtain tissues for diagnosis and ancillary testing has put a huge demand on cytopathologists' time to perform on-site adequacy assessment. The technology of transmitting digital slide images in real-time via the internet from procedure site that can be viewed remotely and provide preliminary diagnosis, has had a huge impact on the practice of ROSE. Telecytology (TC) has increased the efficiency of cytopathologists, by cutting down on travel time to procedure sites and eliminate the long wait time between procedures/needle passes. It also provides the cytopathologist with the flexibility of covering ROSE procedures occurring at several locations simultaneously. The options and design of TC systems are driven by clinical needs, availability of resources and case volume. A buy-in from stakeholders early in the process, infrastructure planning and information technology (IT) support are critical for the successful implementation of TC. Training of staff, validation study and compliance training should be performed according to established guidelines. There are different TC platforms commercially available in the market today, these include static image sharing, real-time video streaming, robotic microscopy and whole slide imaging (WSI). Additionally, low-cost TC system can be built and designed using equipment that are available off-the-shelf. The intent of this review is to highlight the current practices of TC, the pros and cons of each system are discussed.

Role of Pathologist in the Era of Image-Guided and EUS-Guided Aspirations: A 10-Year Study at a Single Tertiary Care Oncology Institute in North India

Background: With improved and readily accessible imaging techniques, the shift in fine-needle aspiration cytology (FNAC) from palpation-guided FNA (PGFNA) to image-guided FNA (IGFNA) and endoscopic ultrasound-guided FNA (EUS-FNA) became evident in last few decades. The present study evaluates the impact of IGFNA and EUS-FNA on the practice of cytopathology at our 300-bedded oncology institute. Study Design: A 10-year audit of three aspiration modalities PGFNA, IGFNA, and EUS-FNA was done. The number of aspirates, inadequacy rates, new patient registration numbers, and tissue biopsy numbers were compared. Results: A total of 29,610 FNAC were evaluated against a total 141,333 new patient registrations over a period of 10 years. The new cancer patient registration over last 10 years showed a 56% increase, with a comparable increase of 60% in diagnostic biopsies; whereas, the number of FNAC increased by only 6%. This reduction in the number of aspirates was mainly due to fall in the number of PGFNA to 18% of all procedures in the year of 2019 from a high of 44% in 2011. Further, PGFNA showed a reduction by 50% over 3 years. The inadequacy rates of PGFNA increased to 9.1% (in 2019) from 1.6% (in 2012). The IGFNA constituted 46%–60% of procedures, with inadequacy varying from 8.5% to 12.1% over years. The EUS-FNAC gradually increased from 3% to 22% from 2013, and the inadequacy rates were variable overtime showing parallelism with the use of rapid on-site adequacy evaluation (ROSE) by the endoscopist. Inadequacy rates ranged from 7.1% (2013) to 2.6% (2016), 7.7% (2017), and 5.4% (2019). Conclusion: The utility of ROSE and diminishing role of pathologist is highlighted in our study. Judicious ROSE improves diagnostic accuracy, decreases the rate of missed diagnosis and the repetition of procedures. The study sheds light on the ever-increasing lacuna in the training of pathologists for blind as well as in image-guided FNAC. Further, it enumerates the factors leading to the underutilization of ROSE, its undisputed advantages, operator variations in procedure, smear preparation, and screening.

Rapid On-Site Evaluation Technical Exercise Using Digital Pathology: Peer Comparison in an External Quality Assurance Setting

Background: The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) is a world leader in the provision of external quality assurance (EQA) for pathology laboratories. The development and delivery of new programmes are designed to meet the evolving needs of our participants and pathology practice. A cytopathology technical programme was established in 2018 to provide proficiency testing in routine cytopreparatory techniques. The cytopathology technical pilot focused on standard operating procedures and laboratory performance during rapid on-site evaluation (ROSE). The exercise aimed to assess the diagnostic adequacy and provide technical recommendations on each of the whole slide images from four fine-needle aspiration biopsy (FNAB) samples of the thyroid in a setting of ROSE. Methods: Four whole slide imaging cases, each comprising one Diff-Quik^TM stained preparation of an FNAB of the thyroid, were provided to all laboratories currently enrolled in the RCPAQAP Cytopathology diagnostic programmes. Each scanned image represented one slide from the first pass collected by a radiologist under ultrasound guidance. Participating laboratories were encouraged to distribute the exercise to individual staff members who attend ROSE procedures. A laboratory practice questionnaire was also conducted. Results: There were a total of 186 submissions received for the assessment across the four virtual cases provided. Although the assessment of on-site adequacy by participants showed high concordance across some of the cases, there was variation in the initial diagnostic evaluation and technical recommendation. Conclusions: ROSE has been adopted as a standard procedure in many laboratories worldwide. A peer comparison of participating laboratories in an EQA exercise has highlighted ROSE as susceptible to variation across standard operating procedures, the provision of diagnostic adequacy, diagnostic feedback to the attending clinician, and technical recommendation.

The Association of “GOOP” on Gross Examination of Fine Needle Aspiration Samples and On-Site Adequacy

Background: Rapid on-site cytologic evaluation (ROSE) is not always available for fine needle aspiration (FNA) specimens. We have examined the relationships between the presence of “GOOP” (defined as gooey white material) on FNA aspirates, on-site adequacy (OSA), and diagnosis. Methods: Consecutive FNA samples obtained over the study interval were included. Samples were assessed macroscopically for the presence or absence of GOOP (GOOP+ or GOOP−). GOOP+ samples were further characterized as shiny (G+_S) or cheesy (G+_C). Gross descriptors were correlated with OSA and final diagnoses. Results: Of the 204 sites biopsied, 102 were malignant, 94 benign, and 8 nondiagnostic. The presence of GOOP was highly predictive for adequacy (positive predictive value 98%). While these correlations for GOOP positivity were significant, the absence of GOOP did not rule out adequacy or malignancy. The presence of GOOP was also significantly correlated with a malignant diagnosis. Conclusions: We have prospectively demonstrated that the presence of GOOP correlates strongly with adequacy. This may be of value for those for whom ROSE is not available and, when available, may help prioritize specimens for on-site review.

Managing Thyroid Nodules in Qatar During the COVID19 Pandemic

Background: The Coronavirus disease 2019 (COVID-19) pandemic impacted health care systems in all countries, including Qatar. Hamad Medical Corporation (HMC); In compliance with recommendations, suspended all non-urgent procedures, including thyroid fine needle aspiration biopsies (FNAB). Thyroid nodules are second most common cause of referral to HMC endocrine clinic. FNABs are gold standard to differentiate benign from malignant nodules.1- 2 Methods: Our approach includes a teleconsultation to obtain patient’s history and risk factors. Reviewing neck ultrasound (US), obtaining a calcitonin level if indicated, considering comorbidities associated with a high risk of COVID-19 morbidity and mortality.3 Results: We developed a pathway triaging thyroid (FNAB) to:1-Urgent: patients at higher risk of aggressive thyroid malignancy. Benefits of early detection and treatment outweigh the risk of COVID-19 exposure.4 FNAB should not be delayed.2-Semi-urgent: patients at low risk for COVID-19 and high suspicion thyroid nodules, but no evidence that early detection improves survival2, FNAB may be delayed up to 12 months.3-Non-urgent: patients with asymptomatic nodules that have low or intermediate suspicion US pattern.2 Also, includes nodules with ATA high suspicion US pattern in pregnant women and patients at high risk for COVID-19. The risks outweigh the benefits. FNAB should be delayed until outbreak is controlled.4 When urgent FNAB is indicated, safety of patients and medical staff needs to be addressed.5 We recommend testing patient for COVID-19 before FNAB, utilizing US guidance with rapid on-site adequacy evaluation in all cases. Cervical lymph node FNAB with TG washout should be done if indicated. The patient should wear a mask. All medical staff involved should wear personal protective equipment (PPE). The operator should wear N95 mask and face shield. The patient should be informed about cytopathology results via telemedicine. Conclusion: Triaging thyroid (FNAB) during the COVID-19 pandemic should be based on nodule characteristics and risk of COVID-19 morbidity and mortality. Our group recommends deferring FNAB for asymptomatic patients.4FNAB should not be delayed in selected patients who benefit from early detection and intervention.Table1: Triage of Thyroid fine needle aspiration biopsies (FNAB). ATA: American thyroid association. US: ultrasound.

Diagnostic utility of fine needle aspiration cytology in pediatric thyroid nodules based on Bethesda Classification.

The Bethesda system for reporting cytopathology (TBSRTC) has been widely adopted in the management of thyroid nodules. Based on the limited pediatric data available, the implied malignancy risk for each of thecategories may be significantly different in pediatrics vs. adults, especially in the indeterminate categories (Bethesda Class III or IV). We report the diagnostic utility of fine needle aspiration (FNA) biopsy at our institution based on the Bethesda system and the risk of malignancy in each category. We retrospectively reviewed all patients who underwent a thyroid FNA at our tertiary pediatric hospital from 12/1/2002 to 11/30/2018. FNA results were classified according to TBSRTC. Patient demographics, cytology, histopathology, radiological and clinical follow-ups were examined. A total of 171 patients were included with 203cytological samples. Average age at initial FNA was 14.7 years (range 6.9-18.6 years). The numbers of nodules reported for Bethesda categories I-VI were 29, 106, 22, 14, 6 and 26, respectively, and the rate of malignancy was: 13.8,4.7, 22.7, 35.7, 83.3 and 100%, respectively. Use of ultrasound guidance reduced the non-diagnostic rate from 38.1 to 11.5%. Introduction of on-site adequacy testing further reduced the non-diagnostic rate to 6.5% since 2014. The risk of malignancy for thyroid nodules inthis pediatric cohort is higher than reported in adults. However, rates described here are much closer to adult ranges than previously published pediatric cohorts. The addition of adequacy testing improved the non-diagnostic rate of FNA procedures performed with ultrasound guidance.

Application of the Milan System for Reporting Salivary Gland Cytopathology: Experience of an academic institution in a tertiary academic medical center.

The Milan System for Reporting Salivary Gland Cytopathology (MSRSGC) represents a standardized reporting system for salivary gland lesions. The recent literature has demonstrated a wide range of data regarding range of malignancy (ROM) and interobserver variability. The objective of the current study was to evaluate the reproducibility and interobserver agreement of MSRSGC, and establish the ROM in a unique patient population residing within a designated Health Professional Shortage Area. A total of 380 salivary gland fine-needle aspiration cases were obtained over a 3-year period. Corresponding cytology reports and slides were reviewed in a blinded fashion by a panel of cytopathologists and recategorized using MSRSGC. ROM was calculated by cytohistologic correlation in 176 cases. Agreement between review of reports and slides and interobserver reliability were determined using kappa statistics. The ROMs per MSRSGC category based on review of reports and slides were as follows: 4% and 0%, respectively, for nonneoplastic; 22% and 0%, respectively, for nondiagnostic; 42.9% and 48%, respectively, for atypia of undetermined significance; 1.6% and 1.9%, respectively, for benign-neoplastic; 17.9% and 15.6%, respectively, for salivary gland neoplasm of uncertain malignant potential; 81.8% and 71.4%, respectively, for suspicious for malignancy; and 100% and 90.5%, respectively, for malignant. There was a 59.2% overall agreement between review of reports and slides with regard to recategorizing salivary gland lesions (kappa, 0.51). The interobserver reliability demonstrated a 64.6% agreement (weighted kappa, 0.59). The ROMs at the study institution appeared comparable to those in the published literature. There was moderate overall agreement among cytopathologists and low interobserver agreement with regard to the indeterminate categories. Image-guided fine-needle aspiration specimens; rapid onsite adequacy; and integration of clinical, imaging, and ancillary studies can improve diagnostic accuracy among indeterminate lesions.

Mesenchymal neoplasms of the tubular gut and adjacent structures: experience with EUS-guided fine-needle aspiration cytopathology

Unlike epithelial malignancies, mesenchymal neoplasms arising within the tubular gut are less often encountered in endoscopic ultrasound-guided (EUS) fine-needle aspiration biopsies (FNABs). Nonetheless, preoperative diagnosis of such neoplasms has important therapeutic and prognostic value. We report our experience with this category of neoplasms from the past decade. We performed a 10-year retrospective search at our respective institutions to identify EUS-guided FNAB cases of mesenchymal neoplasms arising from the tubular gut wall and closely adjacent structures. Cytopathologic diagnoses were compared to corresponding surgical pathology (SP) when available. Cases with either no confirmatory cell block (CB) immunohistochemical (IHC) staining, or no SP were excluded. Two-hundred eighty-two cases (M:F = 1:1; age range: 25-94 years, mean age = 60 years) of EUS-guided FNAB from the tubular gut met our criteria. Onsite adequacy was performed on nearly all cases. Case numbers: 209 gastrointestinal stromal tumors (GIST), 58 smooth muscle neoplasms, and 15 miscellaneous neoplasms. Of these, 188 (67%) had SP follow-up. We found that 258 (91%) aspirates had a correct specific diagnosis, 3 (1%) were nondiagnostic, 18 (6%) had indeterminate diagnoses, and 3 (1%) had incorrect diagnoses (2 leiomyosarcomas mistaken as leiomyoma, and 1 fibrosclerotic lesion mistaken as inflammatory pseudotumor). Of 94 cases with no SP, all had a specific cytologic diagnosis based on confirmatory IHC staining from the CB including 61 GISTs, 29 smooth muscle neoplasms, and 4 miscellaneous tumors. This study endorses the clinical utility of EUS-guided FNAB in the diagnosis of tubular gut mesenchymal neoplasms. A definitive and accurate diagnosis is possible in over 90% of cases, chiefly when cytomorphology is coupled with optimal cellularity and IHC from a concurrent CB. EUS-guided FNAB diagnosis of mesenchymal tubular gut neoplasms may play an important role in determining neoadjuvant therapy as targeted therapy evolves.

Guiding cytotechnology students toward the future: Incorporating the use of ultrasound in FNA training.

Guiding cytotechnology students toward the future: Incorporating the use of ultrasound in FNA training.

ES07.04 Predictive Molecular Testing on Small Biopsy Samples

ES07.04 Predictive Molecular Testing on Small Biopsy Samples

Role of cytotechnologists in rapid onsite adequacy assessment of cytology materials for diagnostic workup and specimen allocation for ancillary testing using a standardized protocol

Data on the performance of cytotechnologists in assessing specimen adequacy of needle core biopsies (NCB) is scant and their role in specimen triaging for ancillary studies have not been well established. We retrospectively analyzed rapid onsite evaluation (ROSE) performed exclusively by cytotechnologists on 248 NCB and fine-needle aspiration (FNA) specimens. Overall adequacy and accuracy rates were determined by comparing to final diagnosis. We also reviewed the process of specimen allocation for ancillary testing to determine whether specimens were appropriately triaged at the time of ROSE. Of the 248 cases, 222 (89.5%) were touch imprint and 26 (10.5%) were FNA smears. The overall adequacy rate was 73.4% (182 of 248). Concordance for "adequate" interpretation by ROSE with unequivocal malignant or benign diagnoses on final interpretation was 95.6%. The sensitivity, specificity, and accuracy of ROSE for a final "positive for malignancy" were 89.2% (95% CI 83.04% to 93.69%), 43.24% (95% CI 31.77% to 55.28%), and 73.87% (95% CI 67.57% to 55.28%), respectively. Cases with "positive for malignancy" on final diagnosis were "adequate" by ROSE in 89.1% (132 of 148) and "inadequate" in 10.8% (16 of 148), P < 0.0001. Ancillary tests were performed in 168 of 248 (67.7%); the majority were immunohistochemical stains for determining tumor subtype. Predictive biomarkers were performed successfully in 100% of metastatic breast cancers. Cytotechnologists performed at a high level of competency in providing ROSE and allocating specimens for ancillary testing, which were performed successfully in the majority of cases. Implementation of a standardized protocol for tissue management/prioritization is of paramount importance to maximize tissue preservation and minimize wastage.

The Accuracy of Rapid On-Site Adequacy Evaluation by Cytotechnologists and the Success Rate of Specimen Collection for Ancillary Testing

The Accuracy of Rapid On-Site Adequacy Evaluation by Cytotechnologists and the Success Rate of Specimen Collection for Ancillary Testing

Psychological Aspects of Utilizing Telecytology for Rapid On-Site Adequacy Assessments

AbstractRapid On-Site Evaluation (ROSE) has been well documented in its ability to improve the diagnostic yield and accuracy of fine needle aspirations across many sites, resulting in better quality of patient management and a simultaneous reduction in treatment costs. Telecytology makes it possible for cytology laboratories to offer ROSE in a cost effective manner, whilst employing only a small number of trained cytopathologists to cover many sites from a single connected location. However, the adoption of telecytology for ROSE has been lackluster. We believe that this reluctance is not only due to barriers such as technology limitations and financial obstacles, but also due to overlooked psychological factors. This article discusses the unaddressed psychological considerations of telecytology for ROSE.

On-Site Adequacy in Pulmonologist-Performed EUS-B-FNA of Subdiaphragmatic Lesions – An Institutional Experience

On-Site Adequacy in Pulmonologist-Performed EUS-B-FNA of Subdiaphragmatic Lesions – An Institutional Experience