3-Dimensional Printed Alternative to the Standard Synthetic Flocked Nasopharyngeal Swabs Used for Coronavirus Disease 2019 Testing.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), can be detected in respiratory samples by real-time reverse transcriptase polymerase chain reaction (RT-PCR) or other molecular methods. Accessibility of diagnostic testing for COVID-19 has been limited by intermittent shortages of supplies required for testing, including flocked nasopharyngeal (FLNP) swabs. METHODS: We developed a 3-dimensional printed nasopharyngeal (3DP) swab as a replacement of the FLNP swab. The performance of 3DP and FLNP swabs were compared in a clinical trial of symptomatic patients at 3 clinical sites (n = 291) using 3 SARS-CoV-2 emergency use authorization tests: a modified version of the Centers for Disease Control and Prevention (CDC) RT-PCR Diagnostic Panel and 2 commercial automated formats, Roche Cobas and NeuMoDx. RESULTS: The cycle threshold-C(t)-values from the gene targets and the RNase P gene control in the CDC assay showed no significant differences between swabs for both gene targets (P = .152 and P = .092), with the RNase P target performing significantly better in the 3DP swabs (P < .001). The C(t) values showed no significant differences between swabs for both viral gene targets in the Roche cobas assay (P = .05 and P = .05) as well as the NeuMoDx assay (P = .401 and P = .484). The overall clinical correlation of COVID-19 diagnosis between all methods was 95.88% (Kappa 0.901). CONCLUSIONS: The 3DP swabs were equivalent to standard FLNP in 3 testing platforms for SARS-CoV-2. Given the need for widespread testing, 3DP swabs printed onsite are an alternate to FLNP that can rapidly scale in response to acute needs when supply chain disruptions affect availability of collection kits.

Northwell Health Laboratories: The 10-Year Outcomes After Deciding to Keep the Lab.

CONTEXT.­: Northwell Health Laboratories were established in 1997, serving the Northwell Health system. In 2008, the health system considered minority entry into a joint venture with a commercial laboratory. Based on arguments made by Northwell laboratory leadership, the decision was made to retain full ownership of the laboratory. OBJECTIVE.­: To evaluate the 10-year outcomes of the 2008 decision and assess the value of a fully integrated laboratory service line for a regional health network. DESIGN.­: Ten-year outcomes were analyzed including financial, volume, and value-based activities. RESULTS.­: First, a fully integrated laboratory service line was created, with unified medical and managerial leadership. Second, Core Laboratory volumes and revenues grew at annualized rates of 4.5% and 16.0%, respectively. Third, hospital-based laboratory costs were held either constant, or grew in accordance with strategic clinical programs. Fourth, laboratory services were able to provide leadership in innovative system clinical programming and value-based payment programs. Fifth, the laboratories became a regional asset, forming a joint venture affiliation with New York City Health + Hospitals, and supporting distressed hospitals in Brooklyn, New York. Lastly, Northwell Health Laboratories have become a reputational asset through leadership in 2 consortia: The Compass Group and Project Santa Fe. CONCLUSIONS.­: The 10-year outcomes have exceeded projections made in 2008, validating the decision to retain the laboratories as a wholly owned system asset. The laboratories are now well positioned for leading innovation in patient care and for helping to drive a favorable posture for the health system under new payment models for health care.

Strengths of the Northwell Health Laboratory Service Line: Maintaining Performance During Threatened Interruptions in Service.

From 2009 to 2015, the laboratories of the 19-hospital North Shore-LIJ Health System experienced 5 threatened interruptions in service and supported 2 regional health-care providers with threatened interruptions in their laboratory service. We report our strategies to maintain laboratory performance during these events, drawing upon the strengths of our integrated laboratory service line. Established in 2009, the laboratory service line has unified medical and administrative leadership and system-wide divisional structure, quality management, and standardization of operations and procedures. Among many benefits, this governance structure enabled the laboratories to respond to a series of unexpected events. Specifically, at our various service sites, the laboratories dealt with pandemic (2009), 2 floods (2010, 2012), 2 fires (2010, 2015), and laboratory floor subsidence (2013). We were also asked to provide support for a regional physician network facing abrupt loss of testing services from closure of another regional clinical laboratory (2010) and to intervene for a non-health system hospital threatened with closure owing to noncompliance of laboratory operations (2012). In all but a single instance, patient care was served without interruption in service. In the last instance, fire interrupted laboratory services for 30 minutes. We conclude that in a large integrated health system, threats to continuous laboratory operations are not infrequent when measured on an annual basis. While most threats are from external physical circumstances, some emanate from unexpected administrative events. A strong laboratory governance mechanism that includes unified medical and administrative leadership across the entirety of the laboratory service line enables successful responses to these threats.

Malignant struma ovarii--a case report and review of the literature.

BACKGROUND: Struma ovarii is a rare monodermal ovarian teratoma composed predominantly of mature thyroid tissue. Of these cases, 5-8% are clinically hyperthyroid and 5-10% of these tumors are malignant. CASE REPORT: A 53-year-old female presented with a 19 x 5 x 5 cm pelvic mass that was treated with bilateral salpingo-oophorectomy, pelvic and para-aortic lymph node sampling, omentectomy and appendectomy and staging for an ovarian tumor. There was no evidence of distant metastases or lymph node invasion. Re-evaluation of the patient after surgery revealed that she was clinically euthyroid and there was no thyroid malignancy. Histopathology revealed papillary thyroid carcinoma arising in struma ovarii (malignant struma ovarii). CONCLUSION: Malignant struma ovarii is a very rare malignant ovarian teratoma. In young patients unilateral oophorectomy and complete surgical staging should be considered when the tumor is confined to the one ovary (stage Ia). Long-term follow-up for the detection of metastases or tumor recurrence by serial serum thyroglobulin and (131)I scan or positron emission tomography/computed tomography may be required in selected patients with this rare tumor.

Differential tissue and subcellular expressionof ERM proteins in normal and malignant tissues: cytoplasmic ezrin expression has prognostic signficance for head and neck squamous cell carcinoma.

BACKGROUND: Members of the ezrin-radixin-moesin (ERM) protein family regulate cellular shape, motility, and proliferation and potentially influence ability to metastasize. We investigated the correlation between ERM subcellular localization and survival in patients with squamous cell carcinoma (SCC) METHODS: Tissue microarrays (TMAs) were constructed from paraffin-embedded tissue. TMA sections were evaluated for ERM protein expression immunohistochemically. The results were compared across clinical and histopathologic variables RESULTS: ERM staining results for 47 patients showed that cytoplasmic ERM expression was prevalent in tumors (>92%). Whereas ezrin and moesin also localized to the membrane, only willin was found in the nucleus of tumors. Multivariable Cox regression analysis demonstrated that strong cytoplasmic ezrin expression was independently associated with poorer survival (p = .04, hazard ratio 1.82) CONCLUSIONS: Both level of expression and subcellular localization of ERM proteins may be important indicators of clinical outcome in SCC. This pilot study justifies the need for an expanded validation study of ERM proteins and clinical outcome.

Techniques for radiofrequency ablation of head and neck tumors.

OBJECTIVES: To describe the various techniques that have been developed for application of radiofrequency ablation in the palliative treatment of recurrent and advanced head and neck malignant tumors. DESIGN: Case series with a follow-up of 3 to 18 months. SETTING: Faculty practice, research protocol, tertiary care academic medical center. PATIENTS: Fifteen treatments were administered over a 3-year period to 12 patients with advanced and/or recurrent tumors. Eleven tumors were squamous cell carcinomas of the oral cavity, oropharynx, and maxillary sinus, and 1 tumor was a medullary thyroid carcinoma. Three of the 12 patients were treated on 2 separate occasions. Patients were selected as a referred sample and sent specifically for treatment with radiofrequency ablation because they were not candidates for the standard curative options of radiation or surgery. No patient refused enrollment, nor were any patients withdrawn because of adverse events. INTERVENTION: Radiofrequency ablation is a method of localized hyperthermia resulting in tissue necrosis. Ninety to 150 W of energy is applied, achieving intratumoral temperatures of 60 to 110 degrees C for 5 to 15 minutes per ablation. Techniques have been developed to apply radiofrequency ablation under direct vision, endoscopically, percutaneously, and with ultrasound and computed tomographic guidance. RESULTS: The radiofrequency ablation probe was accurately placed and treatment administered on 15 occasions. No perioperative deaths occurred. One patient suffered a stroke. Subjective patient improvement was reported with regard to pain (n=9), appearance (n=3), and function (n=4).

Sclerosing lymphocytic lobulitis of the breast in a patient with Graves' disease.

A 43-year-old woman presented to the endocrinologist with symptoms and signs of typical thyrotoxicosis caused by Graves' disease. Review of systems revealed that she had recently discovered a lump in her left breast. Evaluation of the left breast lesion led to a core biopsy that showed sclerosing lymphocytic lobulitis. This breast disease, well recognized in the pathology literature, occurs in various autoimmine disorders, particularly type 1 diabetes mellitus, and has occasionally been reported in Hashimoto's thyroiditis. The patient described here represents the first published association of sclerosing lymphocytic lobulitis of the breast with Graves' disease.