The New York State SARS-CoV-2 Testing Consortium: Regional Communication in Response to the COVID-19 Pandemic.

The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2, created an unprecedented need for comprehensive laboratory testing of populations, in order to meet the needs of medical practice and to guide the management and functioning of our society. With the greater New York metropolitan area as an epicenter of this pandemic beginning in March 2020, a consortium of laboratory leaders from the assembled New York academic medical institutions was formed to help identify and solve the challenges of deploying testing. This report brings forward the experience of this consortium, based on the real-world challenges which we encountered in testing patients and in supporting the recovery effort to reestablish the health care workplace. In coordination with the Greater New York Hospital Association and with the public health laboratory of New York State, this consortium communicated with state leadership to help inform public decision-making addressing the crisis. Through the length of the pandemic, the consortium has been a critical mechanism for sharing experience and best practices in dealing with issues including the following: instrument platforms, sample sources, test performance, pre- and post-analytical issues, supply chain, institutional testing capacity, pooled testing, biospecimen science, and research. The consortium also has been a mechanism for staying abreast of state and municipal policies and initiatives, and their impact on institutional and laboratory operations. The experience of this consortium may be of value to current and future laboratory professionals and policy-makers alike, in dealing with major events that impact regional laboratory services.

Frequency and outcomes of biopsy-proven fibroadenomas recommended for surgical excision.

Our aim was to investigate the outcomes of fibroadenomas recommended for surgical excision due to large size (>2cm) or interval growth. A retrospective review of our institutional radiology database from 2007 to 2015 was performed. We identified 167 biopsy-proven fibroadenomas recommended for surgical consultation. Of these, 75 (45%) cases actually underwent excision, 7 (9%, 95% CI: 4-18%) of which were upgraded to phyllodes tumors upon histopathological examination. Our results support the current recommendation to surgically excise breast lesions diagnosed as fibroadenomas with size >2cm or with interval growth due to the considerable risk of finding phyllodes tumors.

Microinvasive ductal carcinoma in situ: clinical presentation, imaging features, pathologic findings, and outcome.

OBJECTIVE: The purpose of our study was to describe the clinical features, imaging characteristics, pathologic findings and outcome of microinvasive ductal carcinoma in situ (DCISM). MATERIALS AND METHODS: The records of 21 women diagnosed with microinvasive ductal carcinoma in situ (DCISM) from November 1993 to September 2006 were retrospectively reviewed. The clinical presentation, imaging and histopathologic features, and clinical follow-up were reviewed. RESULTS: The 21 lesions all occurred in women with a mean age of 56 years (range, 27-79 years). Clinical findings were present in ten (48%): 10 with palpable masses, four with associated nipple discharge. Mean lesion size was 21mm (range, 9-65mm). The lesion size in 62% was 15mm or smaller. Mammographic findings were calcifications only in nine (43%) and an associated or other finding in nine (43%) [mass (n=7), asymmetry (n=1), architectural distortion (n=1)]. Three lesions were mammographically occult. Sonographic findings available in 11 lesions showed a solid hypoechoic mass in 10 cases (eight irregular in shape, one round, one oval). One lesion was not seen on sonography. On histopathologic examination, all lesions were diagnosed as DCISM, with a focus of invasive carcinoma less than or equal to 1mm in diameter within an area of DCIS. Sixteen (76%) lesions were high nuclear grade, four (19%) were intermediate and one was low grade (5%). Sixteen (76%) had the presence of necrosis. Positivity for ER and PR was noted in 75% and 38%. Nodal metastasis was present in one case with axillary lymph node dissection. Mean follow-up time for 16 women was 36 months without evidence of local or systemic recurrence. One patient developed a second primary in the contralateral breast 3 years later. CONCLUSION: The clinical presentation and radiologic appearance of a mass are commonly encountered in DCISM lesions (48% and 57%, respectively), irrespective of lesion size, mimicking findings seen in invasive carcinoma. Despite its potential for nodal metastasis (5% in our series), mean follow-up at 36 months was good with no evidence of local or systemic recurrence at follow-up. Knowledge of these clinical and imaging findings in DCISM lesions may alert the clinician to the possibility of microinvasion and guide appropriate management.

Atypia on breast core needle biopsies: reproducibility and significance.

This study analyzes the interobserver variability in interpreting atypia on breast core needle biopsies and in each category of atypia calculates the upgrade risk of carcinoma in the subsequent surgical excision. We identified 51 cases of atypia on breast core needle biopsies performed at our institution from January 2003 to August 2006. The atypia was classified into 4 categories: atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), flat epithelial atypia (FEA), and atypia of undetermined significance (AUS). After a tutorial session, these cases were independently reviewed by four pathologists, whose overall multi-rater kappa value for agreement on different categories of atypia was 0.79 (95% CI, 0.69-0.89), which is within the substantial agreement range. The upgrade risk in each category of atypia was as follows: ADH 20% (p = 0.04); ALH 10% (p = 0.6); FEA 16.6% (p = 0.23), and AUS 100% (p = 0.96). Based on our findings, we conclude that follow-up excision should be performed after a diagnosis of ADH. The upgrade risk did not reach statistical significance in ALH or FEA. Although follow-up excision cannot be strongly recommended in ALH and FEA, it should be considered since the upgrade risk is not negligible. Strict adherence to the diagnostic criteria and tutorial sessions can help pathologists to achieve substantial agreement in interpreting atypia on breast core needle biopsies.

Microinvasive breast cancer and the role of sentinel node biopsy: an institutional experience and review of the literature.

Ductal carcinoma in situ with microinvasion (DCISM) is a distinct clinicopathologic entity. Its true metastatic potential has been unclear, due in part to historical differences in the definition of microinvasion. The role of routine axillary staging for DCISM is controversial, given the reportedly low incidence of axillary metastases. We describe our institutional experience with DCISM, and define the role of axillary staging. A retrospective analysis was made of patients with DCISM. Forty-four patients underwent axillary staging (24 axillary lymph node dissection [ALND], 22 sentinel node biopsy [SNB]). Macrometastatic disease was present in three patients (7%), and two patients had isolated tumor cells (itc) in the sentinel node. Patients with axillary metastases tended to be younger. Comedonecrosis, nuclear grade, multifocal microinvasion or presentation as a clinical mass was not associated with a higher rate of axillary metastases. In this series, 7% of patients had macrometastatic disease, and two patients (5%) had itc only. Axillary staging is indicated, and SNB is appropriate for the identification of axillary metastatic disease.

A decade of change: an institutional experience with breast surgery in 1995 and 2005.

INTRODUCTION: With the adoption of routine screening mammography, breast cancers are being diagnosed at earlier stages, with DCIS now accouting for 22.5% of all newly diagnosed breast cancers. This has been attributed to both increased breast cancer awareness and improvements in breast imaging techniques. How have these changes, including the increased use of image-guided sampling techniques, influenced the clinical practice of breast surgery? METHODS: The institutional pathology database was queried for all breast surgeries, including breast reconstruction, performed in 1995 and 2005. Cosmetic procedures were excluded. The results were analysed utilizing the Chi-square test. RESULTS: Surgical indications changed during 10-year study period, with an increase in preoperatively diagnosed cancers undergoing definitive surgical management. ADH, and to a lesser extent, ALH, became indications for surgical excision. Fewer surgical biopsies were performed for indeterminate abnormalities on breast imaging, due to the introduction of stereotactic large core biopsy. While the rate of benign breast biopsies remained constant, there was a higher percentage of precancerous and DCIS cases in 2005. The overall rate of mastectomy decreased from 36.8% in 1995 to 14.5% in 2005. With the increase in sentinel node procedures, the rate of ALND dropped from 18.3% to 13.7%. Accompanying the increased recognition of early-stage cancers, the rate of positive ALND also decreased, from 43.3% to 25.0%. CONCLUSIONS: While the rate of benign breast biopsies has remained constant over a recent 10-year period, fewer diagnostic surgical image-guided biopsies were performed in 2005. A greater percentage of patients with breast cancer or preinvasive disease have these diagnoses determined before surgery. More preinvasive and Stage 0 cancers are undergoing surgical management. Earlier stage invasive cancers are being detected, reflected by the lower incidence of axillary nodal metastases.

Cytomorphologic features of papillary lesions of the male breast: a study of 11 cases.

BACKGROUND: Breast masses occur in men far less commonly than women and are infrequently subjected to fine-needle aspiration (FNA) biopsy. Papillary lesions of the male breast are rare and are comprised of a spectrum of lesions ranging from papillary hyperplasia in gynecomastia to invasive papillary carcinoma. The following study describes the cytomorphology of papillary breast lesions in 11 men. The patients ranged in age from 23 to 78 years old and each presented with an unilateral subareolar or periareolar breast mass that varied in size from 0.5 to 3 cm. Two patients presented with bloody nipple discharge. METHODS: Archival material (8-year period) from FNA biopsies of papillary lesions of the male breast was reviewed. The reviewed cases were correlated with appropriate clinicopathologic follow-up. RESULTS: The smears had variable cellularity but all showed papillary clusters of mammary epithelial cells with and without fibrovascular cores. Single epithelial cells with a high nuclear-to-cytoplasmic ratio and eccentric nuclei were seen in all smears; however, these were more numerous in cases of adenocarcinoma. Hemosiderin-laden macrophages were present in all cases. Nipple discharge was seen only in the 2 benign lesions. All adenocarcinomas occurred in older men. CONCLUSIONS: The only cytologic criteria that differentiated benign from malignant papillary lesions were marked cellularity and the presence of abundant 3-dimensional clusters. To the best of the authors' knowledge, the current series is the largest in the English literature to date that examines the cytomorphologic features of papillary breast lesions in men.

Aspiration biopsy of nodular pseudoangiomatous stromal hyperplasia of the breast: clinicopathologic correlates in 10 cases.

Nodular pseudoangiomatous stromal hyperplasia (PASH) of the breast is rare and often indistinguishable from fibroadenoma, clinically and on aspiration biopsy smears. We report our observations in 10 patients with PASH, evaluated by fine-needle aspiration (FNA) biopsy and core biopsy. We retrospectively reviewed the clinical, radiographic, cytologic, and histologic findings in 10 cases of pure nodular PASH. Ten patients with a presumed clinical and radiologic diagnosis of fibroadenoma underwent aspiration biopsy. The aspiration smears were diagnosed as fibroadenoma (4 cases), cellular fibroadenoma (1 case), schwannoma versus neurofibroma (1 case), fibrocystic change (3 cases; 2 with atypia), and "not specific for a lesion" (1 case). A diagnosis of PASH was not suspected in any case. A discrepant or imprecise cytologic diagnosis and/or the presence of dissociated spindle or epithelial cells, or cellular stromal fragments prompted a surgical excision in 7 of 10 patients (70%). The remaining 3 patients exhibited cytologic features of fibroadenoma and were diagnosed as such; however, surgical excision was recommended. Three patients underwent a subsequent core biopsy, with a diagnosis of PASH being made in 1 patient. FNA biopsy could not discriminate PASH from fibroadenoma in 4 of 10 patients (40%) or suggest a diagnosis of PASH in any case. On retrospective review, the finding of plump, spindle-shaped mesenchymal cells may be a cytologic clue to suggest a diagnosis of PASH.

Aspiration cytology of the oncocytic variant of papillary adenocarcinoma of the thyroid gland.

OBJECTIVE: To study the cytologic features of the oncocytic variant of papillary adenocarcinoma of the thyroid gland to distinguish this subtype from other oncocytic lesions of the thyroid. STUDY DESIGN: We reviewed the smears from aspiration biopsies of 6 proven cases of oncocytic variant of papillary adenocarcinoma and compared their cytologic features with smears from 19 oncocytic follicular neoplasms (11 adenocarcinomas and 8 adenomas). Smears were stained with a modified Giemsa stain (Diff-Quik). RESULTS: All smears were cellular. Colloid was variable but more abundant in cases of the oncocytic variant of papillary adenocarcinoma. The cells in papillary adenocarcinoma had round to ovoid, overlapped nuclei; prominent intranuclear inclusions; and "grooves." Nucleoli were generally absent. In oncocytic follicular neoplasms, the cells had round nuclei and prominent nucleoli. Nuclear inclusions and grooves were seen but were not as prevalent as in papillary adenocarcinomas. CONCLUSION: The oncocytic variant of papillary adenocarcinoma of the thyroid gland can be distinguished from other oncocytic lesions by fine needle aspiration biopsy, whereas the absence of prominent nucleoli in oncocytes favors the diagnosis of an oncocytic papillary adenocarcinoma.

Atypical glandular cells--an update.

The diagnostic category of atypical glandular cells (AGC) in the Bethesda system for the reporting of cervicovaginal cytology has undergone significant modification since its inception in 1988. More than a decade later, this category remains a diagnostic challenge to both clinicians and cytopathologists because of the lack of uniform cytologic criteria, the lack of interobserver agreement in the diagnosis, and the lack of standardized patient management guidelines. This article reviews the current classification of AGC in the Bethesda system, the cytomorphologic features and differential diagnosis, the clinical significance of a diagnosis of AGC, and the clinical management of patients with AGC. This article provides a comprehensive clinicopathologic review of the category of AGC.

Atypical glandular cells.

The 2001 Bethesda System has radically altered the classification of glandular abnormalities. The recognition of the cytologic features of atypical glandular cells on cervicovaginal smears is important because a significant number of patients will be found to have an underlying cancerous or dysplastic lesion of the exocervix, endocervix, or endometrium. The differential diagnosis of AGC on cytology is diverse and accurate classification is necessary because the most appropriate form of follow-up depends on the specific subcategorization of the atypical glandular cells. Because the level of interobserver agreement in the diagnosis of AGC is poor, effective communication between cytopathologists and clinicians is essential to accurately triage these patients. This article should help the cytology practitioner by providing a comprehensive review of the approach to the interpretation, clinical significance, histopathologic correlation, and management of patients who have atypical glandular cells on gynecologic cytology specimens.

Cytology of primary central nervous system neoplasms in cerebrospinal fluid specimens.

Although two-thirds of tumors occurring in the central nervous system (CNS) are primary neoplasms, only 10% of positive cerebrospinal fluid (CSF) specimens are from primary CNS tumors. In this study, we reviewed the cytologic findings of 21 positive CSF specimens from primary CNS tumors. A computer search identified 21 cases of positive CSF specimens from patients with primary CNS tumors from the archives. Follow-up included review of medical charts and histologic correlation. The specimens were from 20 patients (9 females and 11 males). Their ages ranged from 6-83 yr, old with a mean of 30 yr. The cases included 9 medulloblastomas, 7 gliomas (3 glioblastoma multiformes, 2 anaplastic astrocytomas, and 2 ependymomas), 2 germinomas, 2 non-Hodgkin's large B-cell lymphomas, and 1 ganglioneurocytoma. Two cases were classified as suspicious and the remaining as positive for malignancy. Immunocytochemistry was employed in 3 cases to support the cytologic diagnosis. These cases included one large-cell lymphoma (leukocyte-common antigen-positive), one germinoma (placental alkaline phosphatase-positive), and the ganglioneurocytoma (neuron-specific enolase- and synaptophysin-positive). There were no false-positive cases. Our results suggest that positive CSF cytology in patients with a primary CNS tumor is a reliable indicator of malignancy and reflects leptomeningeal involvement. The use of immunocytochemistry is helpful in confirming the cytologic impression in some cases.

The Use of Stereotaxic Core Biopsy and Stereotaxic Aspiration Biopsy as Diagnostic Tools in the Evaluation of Mammary Calcification.

We compared stereotaxic fine needle aspiration biopsy (SFNA) with stereotaxic core needle biopsy (SCB) in the evaluation of radiographically clustered mammary microcalcification, a common finding at screening mammography. Over a 4-year period, 181 specimens were obtained from 175 patients who underwent both SFNA and SCB of clustered microcalcification. Aspiration and core biopsies were performed by radiologists at a community-based diagnostic radiology facility. All aspiration smears were air dried, stained on site, and assessed for adequacy by the radiologists, then sent to the cytopathologists at New York University for interpretation. Core biopsy specimens were formalin fixed, paraffin embedded, hematoxylin and eosin stained, and interpreted by surgical pathologists at a community hospital. Of 181 SFNA specimens, 133 (74%) were benign, 18 (10%) were atypical, 13 (7%) were suspicious, and 16 (9%) were malignant. One (0.5%) aspiration biopsy was nondiagnostic. Excisional biopsies were performed after 12 benign SFNAs and in 46 of the 47 cases with an atypical, suspicious, or malignant diagnosis on SFNA. Mammographic follow-up in 111 of the 133 cases (92%) diagnosed as benign showed no radiologic change (mean 29.2 months, range 6-60 months). The false-negative rate for cancer was 4% (6 cases) for SFNA alone. There were no false-positive diagnoses for SFNA. There was one false-positive diagnosis on core biopsy [focal cribriform ductal carcinoma in situ (DCIS)], which at excisional biopsy and correlation with the core biopsy was diagnosed as ductal hyperplasia; the false-negative rate for cancer was 8% (13 cases) for SCB alone. Aspiration biopsy identified calcification in 180 procedures, core needle biopsy revealed calcification in 170. SFNA was superior to SCB for the confirmation of clustered mammary microcalcification (99% versus 94%) and in the identification of cancer associated with microcalcification (false negative rate of 4% versus 8%). Patients with benign findings on stereotaxic aspiration and core biopsy can reasonably be followed mammographically.