RSSCategory: Laboratory Compliance

To Sign Out or Not to Sign Out? Part 1

| December 27, 2016 | 0 Comments

That is the question. Every year. Around the holidays or three-day weekends. Normally biopsies or surgical specimens collected the day before are reviewed the next day. In a majority of cases, the case can be “signed out” meaning your opinion goes into a surgical pathology report and becomes part of the medical record. New malignancies, […]

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FDA Delays Final Guidance on Regulating LDTs

| November 25, 2016 | 0 Comments

medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as “simple and scarce” as the article mentions, not before a draft guidance issued in 2014 has the FDA […]

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Mikroscan and QualityStar® Partner To Address Subspecialty Case Review In Community Pathology Practices

| October 25, 2016 | 0 Comments

Enabling Economical Digital Pathology Transformation for Next-gen Diagnostic Accuracy in AP San Diego, CA — October 25, 2016 — Mikroscan Technologies, Inc. Mikroscan announced today it has entered into an agreement with QualityStar, LLC., a quality analytics and case review subscription service for Anatomic Pathology, to market its cloud-based and confidential case review to help […]

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Multi-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.

| October 24, 2016 | 0 Comments

Great news from Philips who announced on October 21st their completion of a glass versus digital concordance study to be submitted to FDA.  The press release mentions 2,000 cases with approximately 16,000 reads. The press release goes on to say that the final discordance rate was 1%. Philips will submit the results of the study along […]

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Case Study using HALO™ and STRATA™: Biomarkers of Anti-Tumor Immune Activity Associate with Survival in Melanoma

| September 19, 2016 | 0 Comments

Wednesday September 28th | 8 AM PDT | 11 AM EDT | 4 PM BST Presenters Dr. Tricia Cottrell, Johns Hopkins Medical School  Vlado Ovtcharov, Indica Labs PD-L1 expression in the tumor microenvironment can be both prognostic and predictive.  PD-L1 expression is often a marker of an ongoing CD8+ cytotoxic T-cell-mediated anti-tumor immune response, and thus, […]

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Inspirata Acquires Precision Medicine Network, Inc. and the ‘Crosswalk’ Platform to Bridge the Gap Between Digital Pathology and Molecular Oncology

| September 13, 2016 | 0 Comments

“Crosswalk Insight™: Oncology” enhances Inspirata’s Digital Pathology Cockpit by providing access to Genomic Profiles, FDA-Approved Targeted Therapies, Immunotherapies and Clinical Trials to enable pathologists to make more precise diagnostic and therapeutic decisions. Tampa, FL, September 13, 2016 – Cancer diagnostics and digital pathology workflow solution provider Inspirata, Inc. announced today that it has acquired the assets […]

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QualityStar, Diagnostic Quality Assurance® PSO, First Anatomic Pathology QA Program To Attain Patient Safety Organization (PSO) Listing by HHS

| August 24, 2016 | 0 Comments

DIAGNOSTIC QUALITY ASSURANCE® The Agency for Healthcare Research and Quality Assurance (AHRQ) has approved the Diagnostic Quality Assurance ® (DQA) listing as a Patient Safety Organization (PSO) by the Secretary of the Department of Health and Human Services (HHS). Diagnostic Quality Assurance® PSO is a component entity of QualityStar, LLC (www.qualitystar.net), and is the first […]

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Pathology 2.0 Comes of Age: Recommendations for Protecting Privacy While Motivating Education

| August 10, 2016 | 0 Comments

There is an interesting article in this month’s AMA Journal of Ethics by Drs. Crane and Gardner on the use of pathology images in social media. The authors introduce the article in their abstract as “There is a rising interest in the use of social media by pathologists. However, the use of pathology images on […]

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Biopsy: 5 Things Every Patient Should Know

| July 20, 2016 | 0 Comments

Excellent blog at cancer.net by Dr. Nassar, a professor of pathology at Mayo Clinic – Jacksonville.  Aziza and I were residents together and worked together at Mayo Clinic -Rochester.  She has always been a strong patient advocate, always keeping the patient at the forefront of her work in all of her clinical and research endeavors. Thank […]

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Investors Inject $1M in Digital Pathology Startup Proscia®

| July 5, 2016 | 0 Comments

BALTIMORE, Maryland — July 5th, 2016 — Proscia Inc., a data solutions provider for digital pathology, announced today the completion of its $1M seed round of financing. Proscia, whose Pathology Cloud platform is already helping hundreds of pathologists and researchers, will use the proceeds to accelerate growth and pursue the company’s vision of unlocking insights […]

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Protect Patients and Improve Productivity with CEREBRO Sample Tracking via WindoPath and NucleoLIS Integration

| July 1, 2016 | 0 Comments

Vista, CA – June 30, 2016 — Leica Biosystems, a global leader in automation and workflow solutions for anatomic pathology, announced the integration of Leica Biosystems CEREBRO Sample Tracking System with Psyche Systems’s WindoPath and NucleoLIS products. The aim of this collaboration is to increase the efficiency and quality of laboratory pathology services by reducing […]

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While You Were Sleeping – Do You Know Where Your Specimen Is?

| June 27, 2016 | 0 Comments

What really happens to your surgical specimen? It is one of the most frightening events in a person’s life… an unusual lump that needs to come out. You visit your primary care physician. He refers you to a “specialist” who will remove your unusual growth while you are under anesthesia. What happens to that piece […]

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Leica Biosystems and Pathline Team Up to Address Patient Safety

| June 14, 2016 | 0 Comments

CEREBRO sample tracking and workflow solution deployed to reduce errors Pathline Emerge, a leading provider of subspecialized anatomic pathology services, has teamed up with Leica Biosystems, a global leader in pathology solutions. In order to fight against medical errors in the laboratory, such as the misidentification of cancer tests, Pathline has implemented Leica Biosystems CEREBRO, […]

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