FEMA Paid a Just-Formed Company Millions of Dollars for COVID-19 Specimen Collection Tubes That Were Unusable for Clinical Laboratory Testing
The fledgling test-kit company sent plastic preforms that were intended for use in the manufacturing of soda bottles, not clinical laboratory specimen tubes When is a specimen tube not a specimen tube? When it is a plastic tube made for creating soda bottles. And that may be exactly what the Federal Emergency Management Agency (FEMA) […] (Source: Dark Daily)
Source: Dark Daily - July 31, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory News Laboratory Pathology anatomic pathology Association of Public Health Laboratories clinical laboratory clinical patholo Source Type: news

New CMS Proposed Rule Encourages Value-Based Reimbursement Based on Patient Outcomes When Payers and Drug Manufacturers Negotiate Payment for Pricey Therapies
Clinical laboratories and anatomic pathology groups should consider this another example of how CMS is taking forward steps to encourage value-based payment arrangements throughout the health system With the sky-high cost of many prescription drugs and gene therapies, it was only a matter of time before the Centers for Medicare and Medicaid Services (CMS) would […] (Source: Dark Daily)
Source: Dark Daily - July 29, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Alexander Dworkowitz anatomic pathology centers for medicare and medicaid services clin Source Type: news

Clinical Diagnostics Laboratory in Texas Charged $2,315 for One Coronavirus Test and Later Claims High Price Was a ‘Billing Error’
Media reporting on disparities in COVID-19 test billing sparks renewed calls for increased transparency in medical laboratory test charges Recent media reports of massive disparities in the prices charged for COVID-19 lab tests throughout the United States have citizens and law makers alike again calling for increased transparency in clinical laboratory test charges. One recent […] (Source: Dark Daily)
Source: Dark Daily - July 27, 2020 Category: Laboratory Medicine Authors: Jude Tags: Coding, Billing, and Collections Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology aetna anatomic pathology and Economic Security Act Angie Meoli Blue Cro Source Type: news

COVID-19 is Mutating and A Scripps Research Study Reveals the Coronavirus May Become Even More Infectious
Researchers found evidence indicating that the virus has—under selection pressure—made itself more stable, giving it a “significant boost in infectivity” While the COVID-19 pandemic continues to spread across the United States and throughout the world, new research suggests that a coming genetic mutation within the SARS-CoV-2 coronavirus may make it much more dangerous than it […] (Source: Dark Daily)
Source: Dark Daily - July 24, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment International Laboratory News Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory Pathology Laboratory Testing Management & Operations Precision Medicine anatomic pathology Source Type: news

Banner Health Introduces Virtual Waiting Rooms in 300 Medical Clinics Across Its Nationwide Healthcare System
As digital healthcare continues to gain acceptance and regulatory support, clinical laboratories will need to help patients provide biological samples for virtual doctor visits Patterns are emerging in healthcare that will likely impact clinical laboratories now and into the future. Trends in telehealth and mobile health (mHealth) that were just beginning to develop before the […] (Source: Dark Daily)
Source: Dark Daily - July 22, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations anatomic pathology Banner Health chatbots cli Source Type: news

With Consumer Demand for Ancestry and Genealogy Genetic Tests Waning, Leading Genomics Companies are Investigating Ways to Commercialize the Aggregated Genetics Data They Have Collected
Genomics experts say this is a sign that clinical laboratory genetics testing is maturing into a powerful tool for population health Faced with lagging sales and employee layoffs, genomics companies in the genealogy DNA testing market are shifting their focus to the healthcare aspects of the consumer genomics data they’ve compiled and aggregated. Recent analysis […] (Source: Dark Daily)
Source: Dark Daily - July 20, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Sales and Marketing Laboratory Testing Management & Operations Precision Medicine 23 Source Type: news

Clinical Laboratory Testing of USS Theodore Roosevelt ’s Crew During COVID-19 Outbreak Offers Insights into the Coronavirus’ Impact on Young Healthy Adults
The CDC and US Navy study reveals common symptoms and suggests best protective measures to prevent spread in enclosed environments that clinical labs and pathology groups could use to protect their staff members Results from a study conducted by the US Navy and the federal Centers for Disease Control and Prevention (CDC) of sailors onboard […] (Source: Dark Daily)
Source: Dark Daily - July 17, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Pathology anatomic pathology BUMED Bureau of Medicine and Surgery Captain Brett Crozier CDC clinical laboratory clinical pathology Coronavirus COVID-19 Dan Payne PhD Dark Daily dark intelligence group Dark Report ELI Source Type: news

Federal Prosecutors Charge a California Executive with Misleading Investors and Payers about Company ’s Clinical Laboratory COVID-19 Test
Charges against this life science company executive include healthcare fraud as well as the first COVID-19 related securities fraud In the first securities fraud prosecution involving clinical laboratory COVID-19 testing, the US federal Department of Justice (DOJ) charged the president of a Sunnyvale, Calif., life sciences biotechnology company with participating in a scheme to mislead […] (Source: Dark Daily)
Source: Dark Daily - July 15, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations anatomic pathology Arrayit Corporation Brian Benczkowski clin Source Type: news

Pathologists Bill Out-of-Network More Frequently than Other Specialties, According to Health Care Cost Institute Study
Two national studies find pathologists bill out-of-network more frequently than other hospital-based specialties, and one study links that behavior to insurer reimbursement rates Surprise bills for out-of-network services continue to be an important issue for healthcare consumers. Now comes a recently-released report from the Health Care Cost Institute (HCCI) claiming that pathologists are the specialists […] (Source: Dark Daily)
Source: Dark Daily - July 13, 2020 Category: Laboratory Medicine Authors: Jude Tags: Coding, Billing, and Collections Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations anatomic pathology clinical laboratory clinical p Source Type: news

Federal Prosecutors Add a 12th Felony Fraud Charge in Latest Criminal Indictment Against Theranos Founder Elizabeth Holmes
Holmes’ lawyers maintain the former CEO of Theranos has not waived right to be charged by indictment and therefore argue the added charge is ‘unconstitutional’ and should be dismissed Clinical laboratory leaders needing a break from nonstop coronavirus pandemic news will be interested to learn a familiar name is again making headlines. Disgraced Theranos founder […] (Source: Dark Daily)
Source: Dark Daily - July 10, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory News Laboratory Pathology Laboratory Testing Management & Operations anatomic pathology clinical laboratory clinical pathology CNBC Coronavirus COVID-19 Dark Daily dark intelligence gro Source Type: news

Two Florida Clinical Laboratory COVID-19 Test Contracts Come Under Scrutiny
One medical testing company was led by a convicted felon, another was accused of delays and unreliable results Like many states, Florida has worked hard to quickly ramp up diagnostic testing for SARS-CoV-2, the coronavirus that causes the COVID-19 illness. For the most part this has been a good thing. However, local media in that […] (Source: Dark Daily)
Source: Dark Daily - July 8, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations News From Dark Daily Advanced BioHealing AdventHealth anatomic pathology clinica Source Type: news

New Gene Sequencing Method for Studying Circular DNA Found in Viruses, Bacteria, and other Cells, May Lead to Development of New Clinical Laboratory Biomarkers
University of Alberta researchers developed CIDER-Seq tool and protocols for the study, which they have made freely available to all scientists Here’s another promising new technology which, given more research into effectiveness and safety, may soon lead to improved clinical laboratory cancer diagnostics. Oncology research scientists have focused much attention on understanding the role of […] (Source: Dark Daily)
Source: Dark Daily - July 6, 2020 Category: Laboratory Medicine Authors: Jude Tags: Digital Pathology Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology anatomic pathology Birgitte Regenberg PhD CIDER-Seq circular DNA clinical l Source Type: news

Australia Spent $200 Million (AUD) on Chinese COVID-19 Diagnostic Testing Kits That Went into The Country ’s Strategic Reserve Rather than Being Used
Australian government heralded April purchase of 10 million clinical laboratory diagnostics tests from BGI, but most of the nation’s states and territories say kits are unneeded or unable to be used by their health departments While the United States and other nations attempt to bring the COVID-19 outbreak under control, many countries have turned to […] (Source: Dark Daily)
Source: Dark Daily - July 1, 2020 Category: Laboratory Medicine Authors: Jude Tags: International Laboratory News Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory Pathology Laboratory Testing ABC News anatomic pathology Andrew Forrest BGI Genomics clinical laboratory clinic Source Type: news

Multiple Studies Raise Questions About Reliability of Clinical Laboratory COVID-19 Diagnostic Tests
In the absence of a “gold standard,” researchers are finding a high frequency of false negatives among SARS-CoV-2 RT-PCR tests Serology tests designed to detect antibodies to the SARS-CoV-2 coronavirus that causes the COVID-19 illness have been dogged by well-publicized questions about accuracy. However, researchers also are raising concerns about the accuracy of molecular diagnostics […] (Source: Dark Daily)
Source: Dark Daily - June 29, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations Precision Medicine Abbott Di Source Type: news

FTC Orders Hospital, Health System, and Five Insurers in Two States to Share Vast Amounts of Data on Their Customers and on Past Acquisitions and Mergers
Lab leaders may recall similar requests for data from other government agencies and wonder if FTC will take steps to investigate pricing and competition among clinical laboratories as well It appears that the Federal Trade Commission (FTC) is ready to look into hospital consolidation, as evidenced by the extent of data—including pricing and managed care […] (Source: Dark Daily)
Source: Dark Daily - June 26, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory News Laboratory Pathology Managed Care Contracts & Payer Reimbursement News From Dark Daily Source Type: news

Molecular Testing for Urinary Tract Infection (UTI): 2020 Update on Clinical Utility and Reimbursement Trends
Molecular tests are becoming more routine as diagnostic tools, with many now covered by Medicare and commercial insurers. Advantages of molecular tests based on PCR technology include their ability to identify uropathogens traditionally missed by culture-based tests. Driven by urgent, unmet analytical and clinical care needs, the adoption of the rapid molecular test—particularly RT-PCR for urinary tract infection control and treatment—has important implications. (Source: Dark Daily)
Source: Dark Daily - June 24, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology White Papers dark daily white paper molecular test advances white paper RT-PCR white paper thermo fisher white paper Source Type: news

FREE SPECIAL EDITION WHITE PAPER | Molecular Testing for Urinary Tract Infection (UTI): 2020 Update on Clinical Utility and Reimbursement Trends
Molecular tests are becoming more routine as diagnostic tools, with many now covered by Medicare and commercial insurers. Advantages of molecular tests based on PCR technology include their ability to identify uropathogens traditionally missed by culture-based tests. Driven by urgent, unmet analytical and clinical care needs, the adoption of the rapid molecular test—particularly RT-PCR for urinary tract infection control and treatment—has important implications. (Source: Dark Daily)
Source: Dark Daily - June 24, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology White Papers Source Type: news

Medical Laboratory Test Data and Clinical Lab 2.0 are Powering Dashboards That Help Providers Mitigate COVID-19 and Improve Population Health
Coronavirus informatics companies are drawing clinical laboratory test data out of the shadows and into the light and compiling it into critical bioinformatics resources What better example do we have that clinical laboratory test data is critical to population health than the current COVID-19 pandemic? Medical laboratory scientists, bioinformatics developers, and government healthcare leaders are […] (Source: Dark Daily)
Source: Dark Daily - June 24, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations Source Type: news

Case Studies in Clinical Laboratory Test Stewardship: The Financial and Clinical Impact of Clinical Decision Support in Hospital Laboratories
This white paper – the third in a three-part series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare – provides frontline perspective and commentary from experts and physicians on the application and value of decision support in the laboratory. It also includes early-adopter proof points from hospital laboratories that have successfully implemented third-party decision support to achieve their stewardship goals, including EHR interventions and ongoing monitoring of utilization. (Source: Dark Daily)
Source: Dark Daily - June 23, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology White Papers Source Type: news

FREE SPECIAL EDITION WHITE PAPER | Case Studies in Clinical Laboratory Test Stewardship: The Financial and Clinical Impact of Clinical Decision Support in Hospital Laboratories
This white paper – the third in a three-part series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare – provides frontline perspective and commentary from experts and physicians on the application and value of decision support in the laboratory. It also includes early-adopter proof points from hospital laboratories that have successfully implemented third-party decision support to achieve their stewardship goals, including EHR interventions and ongoing monitoring of utilization. (Source: Dark Daily)
Source: Dark Daily - June 23, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology White Papers Source Type: news

Translating Clinical Laboratory Science Into Business Objectives: How an Educational Program Measured and Analyzed Performance and Transformed the Approach to Improving Laboratory Operations
Now more than ever before, clinical labs are under pressure to operate efficiently, accurately, and timely, all while still making money. Doctors and patients have come to expect a 24-hour turnaround for most tests. Clinical labs throughout the United States have been slashing budgets, many literally to the point of no return. At least 13 public health labs in four states have shuttered since 2003, which posed a serious problem when COVID-19 hit because resources did not meet demand. (Source: Dark Daily)
Source: Dark Daily - June 22, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Pathology White Papers dark daily white paper free white paper Lab Logistics white paper quality improvement white paper risk management white paper specimen management white paper Source Type: news

FREE SPECIAL EDITION WHITE PAPER | Translating Clinical Laboratory Science Into Business Objectives: How an Educational Program Measured and Analyzed Performance and Transformed the Approach to Improving Laboratory Operations
Now more than ever before, clinical labs are under pressure to operate efficiently, accurately, and timely, all while still making money. Doctors and patients have come to expect a 24-hour turnaround for most tests. Clinical labs throughout the United States have been slashing budgets, many literally to the point of no return. At least 13 public health labs in four states have shuttered since 2003, which posed a serious problem when COVID-19 hit because resources did not meet demand. (Source: Dark Daily)
Source: Dark Daily - June 22, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Pathology White Papers dark daily white paper free white paper Lab Logistics white paper quality improvement white paper risk management white paper specimen management white paper Source Type: news

FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests
Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens […] (Source: Dark Daily)
Source: Dark Daily - June 22, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory News Laboratory Pathology Laboratory Testing Management & Operations Abbott Diagnostics anatomic pathology Cepheid clinical laboratory clinical pathology Coronavirus COVID-19 Dark Daily dark intelligence group Dark Rep Source Type: news

Mobile Device Software Companies Are Developing Smartphone Apps That Use Artificial Intelligence to Test for COVID-19, Potentially Bypassing the Clinical Laboratory Altogether
This is another example of technology companies working to develop medical laboratory testing that consumers can use without requiring a doctor’s order for the test Here’s new technology that could be a gamechanger in the fight against COVID-19 if further research allows it to be used in patient care. The goal of the researchers involved […] (Source: Dark Daily)
Source: Dark Daily - June 19, 2020 Category: Laboratory Medicine Authors: Jude Tags: Coding, Billing, and Collections Digital Pathology Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing A Source Type: news

FDA ’s Regulatory Hurdles ‘Paralyzed’ Efforts of CLIA-Certified Clinical Laboratories to Offer Alternatives to CDC’s Flawed COVID-19 Test
Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic test last February, many CLIA-certified academic and public health laboratories were ready, and […] (Source: Dark Daily)
Source: Dark Daily - June 17, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations Alex Azar Al Source Type: news

Washington Post Investigation into CDC ’s Failed Rollout of COVID-19 Tests Shows Federal Government’s Missteps and Miscalculations, Part One of Two
Previously unreported email messages and documents paint vivid picture of public health laboratory officials’ dismay and frustration over testing delays Between late January and early March, Clinical laboratory leaders watched with dismay as federal government missteps crippled the Centers for Disease Control and Prevention’s (CDC) rollout of its COVID-19 diagnostic testing in the early days […] (Source: Dark Daily)
Source: Dark Daily - June 15, 2020 Category: Laboratory Medicine Authors: Jude Tags: Uncategorized anatomic pathology Associated Press Association of Public Health Laboratories CDC centers for disease control and prevention clinical laboratory clinical pathology CNBC Coronavirus COVID-19 Dark Daily dark intelligenc Source Type: news

Thirty US Congress Members Ask HHS To Send COVID-19 Testing Funds Directly to Clinical Laboratories
US Representatives want clinical laboratories to have better support for their increased efforts to expand testing for the coronavirus On June 8, Congressmen Tom Reed (NY-23), Scott Peters (CA-52), and 28 other members of the US House of Representatives sent a letter to Secretary of the Department of Health and Human Services (HHS) Alex Azar […] (Source: Dark Daily)
Source: Dark Daily - June 12, 2020 Category: Laboratory Medicine Authors: Jude Tags: Uncategorized ACLA AMA american clinical laboratory association american medical association anatomic pathology BARDA Biomedical Advanced Research and Development Authority CARES Act CDC centers for disease control and prevention CLF Source Type: news

In the Field, Clinical Laboratory Specimen Transportation is Being Complicated by the COVID-19 Pandemic
Lab leaders who adopt best practices in courier services will help ensure their lab’s supply chains remain secure Hospital and health systems using courier services to transport patients’ biological specimens from doctors’ offices and other locations to clinical laboratories for testing and reporting are finding those services delayed or disrupted by the COVID-19 pandemic.   […] (Source: Dark Daily)
Source: Dark Daily - June 10, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations anatomic pathology Brian McArdle clinical laboratory Source Type: news

Sean Penn ’s Foundation Partners with Healthcare Providers in Four States to Offer Drive-Thru COVID-19 Molecular and Serological Clinical Laboratory Specimen Collections
Goal of his foundation is to provide access to COVID-19 medical laboratory tests for first responders, as well as low-cost tests to the general public Early in April, when many of the nation’s clinical laboratories were facing numerous challenges in their attempts to obtain adequate supplies for collecting, transporting, and testing for COVID-19, a Hollywood […] (Source: Dark Daily)
Source: Dark Daily - June 8, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory News Laboratory Pathology Laboratory Testing Management & Operations anatomic pathology Ann Lee antibody tests City of Malibu clinical laboratory Community Organized Relief Effort CORE Coronavirus COVID Clinic COVID-19 Source Type: news

UnitedHealthcare Announced It Would Cover Certain Pharmacogenomic Tests; However, Experts Hotly Debate the Value of Such Clinical Laboratory Testing
Though more payers are covering laboratory-developed genetic tests for conditions such as depression, the tests remain uncleared by the FDA Clinical pathologists interested in pharmacogenetics tests for depression and other psychiatric disorders may be interested to learn that UnitedHealthcare (NYSE:UNH) announced in its Network Bulletin a change to its Molecular Pathology Policy and is now […] (Source: Dark Daily)
Source: Dark Daily - June 5, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations Source Type: news

Federal Government Is Sending Nearly $11 Billion to States for COVID-19 Clinical Laboratory Testing and Testing-Related Activities
Questions remain, however, over how much of the funding will actually reach hospital and health system clinical laboratories For many cash-strapped clinical laboratories in America, the second round of stimulus funds cannot come soon enough. Thus, lab leaders are encouraged by news that Congress’ $484-billion Paycheck Protection Program and Healthcare Enhancement Act (H.R.266) includes almost […] (Source: Dark Daily)
Source: Dark Daily - June 3, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Managed Care Contracts & Payer Reimbursement Management & Operations american clinical laboratory association anatomic pathology Ashish Jha MD Source Type: news

Harvard ‘Roadmap’ to Recovery Calls for ‘Massive’ Increase in Clinical Laboratory COVID-19 Testing in Four-Phase Blueprint for Reopening Economy
Report’s authors claim the US needs to be testing 20-million people per day in order to achieve ‘full pandemic resilience’ by August Medical laboratory scientists and clinical laboratory leaders know that the US’ inability to provide widespread diagnostic testing to detect SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—in the early stages of the outbreak […] (Source: Dark Daily)
Source: Dark Daily - June 1, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Hiring & Human Resources Laboratory Management and Operations Laboratory News Laboratory Pathology anatomic pathology Anne-Marie Slaughter Ashish Jha MPH CDC centers for disease control and prevention clinical laboratory cli Source Type: news

Health Insurers and Hospital Groups Argue Price Transparency Rules on Hospitals, Clinical Laboratories, and Other Providers Will Add Costs and ‘Confuse’ Consumers
Insurance industry claims new federal price transparency regulations cost each payer as much as $13.6 million in set up and maintenance costs Price transparency in hospital, clinical laboratory, and other service provider costs marches ever closer to reality for America’s healthcare consumers. Meanwhile, some insurers and hospital groups are working to block implementation of federal […] (Source: Dark Daily)
Source: Dark Daily - May 29, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations AHA American Hospital Association anatomic pathology Bates Wh Source Type: news

Roche CEO Severin Schwan Questions the Ethics of Certain Companies Making COVID-19 Antibody Tests and Calls Some of These Clinical Laboratory Tests a ‘Disaster’
Schwan’s concerns about inaccurate or unreliable COVID-19 serology tests were supported when the FDA issued more restrictive rules for these medical laboratory tests on May 4 Last month, Roche Group CEO Severin Schwan characterized some COVID-19 antibody tests as a “disaster” and questioned the ethics of some manufacturers of these tests. During a conference call […] (Source: Dark Daily)
Source: Dark Daily - May 27, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory News Laboratory Operations Laboratory Pathology anatomic pathology antibodies antibody tests APHL Association for Public Health Laboratories Association Press Bloomberg clinical laboratory clinical pathology COVID-19 D Source Type: news

Walmart Opens Second Health Center Offering Clinical Laboratory Tests and Primary Care Services
In another example of giving consumers more direct access to medical laboratory tests, Walmart believes that convenience and lower prices can help it capture market share Retail giants continue to add healthcare services—including medical laboratory testing—to their wares. It’s a trend that pressures hospital systems, clinical laboratories, pathology groups, and primary care providers to compete […] (Source: Dark Daily)
Source: Dark Daily - May 22, 2020 Category: Laboratory Medicine Authors: Jude Tags: Uncategorized Amazon Care anatomic pathology clinical laboratory CVS Health Dark Daily dark intelligence group Dark Report Health Care Cost Institute hemoglobin A1c Jeffrey Tharp MD Kaufman Hall Kenneth Kaufman lab testing lipi Source Type: news

With So Many New COVID-19 Serology Tests Obtaining EUAs from the FDA, How Can Clinical Laboratories Identify Tests That Should Perform Reliably?
As federal and state officials ease many regulatory requirements to speed new COVID-19 serology tests to market with minimum data about performance, labs are left with important questions to answer on their own Every day, elected officials at all levels of government call for a huge expansion of COVID-19 serology testing. But, as most clinical […] (Source: Dark Daily)
Source: Dark Daily - May 20, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations Abbott Laboratories anatomic pathology clinical laboratory clinical path Source Type: news

Where Are the Patients? Hospitals and Clinical Laboratories Wonder When Routine Surgeries, Procedures, and Testing Can Be Restarted Once the COVID-19 Outbreak Eases
Even as some states lift stay-at-home orders, clinical laboratories and pathology groups face uncertainty about how quickly routine daily test referrals will return to normal, pre-pandemic levels Although strokes and heart attacks do not take vacations, a large and growing number of patients with serious health issues who—in normal times—would require immediate attention are not […] (Source: Dark Daily)
Source: Dark Daily - May 18, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations AHA American College of Cardiology American Hospital Associatio Source Type: news

Woman Who Can Smell Parkinson ’s Disease in Patients Even Before Symptoms Appear May Help Researchers Develop New Clinical Laboratory Test
She worked with researchers at the University of Manchester in England to identify volatile biomarkers for Parkinson’s disease that may lead to first noninvasive screening Clinical pathologists and medical laboratories are used to working with certain biological indicators that drive diagnostics and clinical laboratory testing. Mostly, those biomarkers are contained within various liquid samples, such […] (Source: Dark Daily)
Source: Dark Daily - May 15, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology ACS Central Science American Cancer Society anatomic pathology BBC cl Source Type: news

US Works with Clinical Laboratories to Launch Several Large-Scale COVID-19 Serological Surveys to Track Undetected COVID-19 in the Nation ’s Population
Though some experts claim widespread antibody testing is key to effective public health safety, the WHO warns positive serological tests may not indicate immunity from reinfection or transmission of SARS-CoV-2 It may be the largest program of clinical laboratory testing ever conducted in the United States. Health officials are preparing to undertake large-scale serological surveys […] (Source: Dark Daily)
Source: Dark Daily - May 13, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Management & Operations News From Dark Daily anatomic pathology clinical laboratory clinical pathology Coronavirus COVID-19 dark intellig Source Type: news

New CDC-led Genomics Consortium That Harnessed Genetic Sequencing to Track the SARS-CoV-2 Coronavirus includes Clinical Laboratories and IVD Firms
Medical laboratories are already using gene sequencing as part of a global effort to identify new variants of the coronavirus and their genetic ancestors Thanks to advances in genetic sequencing technology that enable medical laboratories to sequence organisms faster, more accurately, and at lower cost than ever before, clinical pathology laboratories worldwide are using that […] (Source: Dark Daily)
Source: Dark Daily - May 11, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory News Laboratory Pathology Management & Operations Precision Medicine Abbott Diagnostics Advanced Molecular Detection AMD anatomic pathology bioMerieux CDC centers for disease control and prevention clinical laboratory cl Source Type: news

COVID-19 Pandemic Triggers Decline in Anatomic Pathology Testing and Shows How Digital Pathology, Remote Sign-Out Can Increase Pathology Services
Because of ‘shelter in place’ orders, many anatomic pathologists are reviewing digital images from home during the COVID-19 outbreak and demonstrating the value of whole slide imaging, digital pathology, and CMS’ recent amended remote sign-out policy COVID-19 is already triggering many permanent changes in the way healthcare is organized and delivered in the United States. […] (Source: Dark Daily)
Source: Dark Daily - May 8, 2020 Category: Laboratory Medicine Authors: Jude Tags: Compliance, Legal, and Malpractice Digital Pathology Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Laboratory Testing Source Type: news

FREE SPECIAL EDITION WHITE PAPER | Risk Management Specimen Management and Logistics Issues to Evaluate for Continuous Quality Improvement – 3 High-Risk Medical Courier Support Services
As a member of your laboratory’s leadership team, learn what you need to know as a competitive laboratory to maximize efficiency, increase profitability, and decrease costs over the long run by leveraging effective medical courier services and those that utilize digital technologies. (Source: Dark Daily)
Source: Dark Daily - May 7, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Pathology White Papers dark daily white paper free white paper Lab Logistics white paper quality improvement white paper risk management white paper specimen management white paper Source Type: news

UC Berkeley Creates COVID-19 Robotic Testing Laboratory in Record Time by Reallocating Equipment and Training Researchers to Do Clinical Analysis
Medical laboratory leaders may be inspired by this rapid start-up and its outreach to students and the Bay area In what could take a typical clinical laboratory months or even years to launch, the Innovative Genomics Institute (IGI) at the University of California, Berkeley managed to make a COVID-19 diagnostic testing laboratory operational in just […] (Source: Dark Daily)
Source: Dark Daily - May 6, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Pathology 2019-nCoV Real-Time RT-PCR Diagnostic Panel anatomic pathology California state of emergency declaration CDC centers for disease control and prevention clinical laboratory Coronavirus COVID-19 COVID-19 Testing Lab Source Type: news

COVID-19 Triggers a Cash Flow Crash at Clinical Labs Totaling US $5.2 Billion in Past Seven Weeks; Many Labs Are at Brink of Financial Collapse
Limited availability of COVID-19 clinical lab tests is major topic at federal briefings and news stories, yet many of nation’s labs are laying off staff and at point of closing Cash flow at the nation’s clinical laboratories has crashed, with revenues down by more than $5 billion since early March. This is the biggest financial […] (Source: Dark Daily)
Source: Dark Daily - May 4, 2020 Category: Laboratory Medicine Authors: Jude Tags: Laboratory Management and Operations Laboratory Operations Laboratory Pathology Management & Operations News From Dark Daily Advocate Aurora Health anatomic pathology ARUP Laboratories BioReference Laboratories Cleveland Clinic CLIA Source Type: news

COVID-19 Disruptions of Supply Chains Are One More Challenge for Clinical Laboratories to Bring Value to Hospitals and Healthcare Networks
Supply chain experts can explain ways clinical laboratories should evaluate their suppliers and sources Suddenly, supply chain management has become a critical success factor as hospitals, health systems, and clinical laboratories throughout the United States respond to the COVID-19 pandemic. Demand for essential supplies has left many health network medical laboratories vulnerable and understocked. One […] (Source: Dark Daily)
Source: Dark Daily - May 1, 2020 Category: Laboratory Medicine Authors: Jude Tags: Uncategorized Source Type: news

FDA Issues First Approval for At-Home COVID-19 Test to LabCorp ’s Pixel; Other Clinical Laboratory-Developed At-Home Test Kits May Soon Be Available to General Public
Though the potential is high for false positives and false negatives, some experts believe at-home COVID-19 testing still holds promise for slowing the spread of the coronavirus Laboratory Corporation of America (LabCorp) is the first diagnostic test developer to receive approval from the US Food and Drug Administration (FDA) to market an at-home specimen collection […] (Source: Dark Daily)
Source: Dark Daily - April 29, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Pathology Source Type: news

In New Hampshire, Cooperation Was Key to Handling Clinical Laboratory Testing Challenges Posed by the COVID-19 Outbreak
Facing a backlog, the state’s public health laboratory turned to the medical laboratory at Dartmouth Hitchcock Medical Center Much of the attention surrounding the COVID-19 outbreak—the illness caused by the SARS-CoV-2 coronavirus—has focused on large urban areas such as New York City and Los Angeles. However, the virus is impacting many rural areas as well. […] (Source: Dark Daily)
Source: Dark Daily - April 27, 2020 Category: Laboratory Medicine Authors: Jude Tags: Digital Pathology Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Abbott m2000 assay anatomic pathology CAP CDC centers for disease control and prevention Christine L. Bean PhD CLIA c Source Type: news

Tech Companies Suggest Ways Location Tracking Could Help Health Authorities Fight the COVID-19 Coronavirus by Identifying People Who May Need Clinical Laboratory Testing
Privacy concerns have one tech giant suggesting alternatives to sharing potentially identifiable location tracking data Expect an interesting debate on the use of location tracking as a way to manage this and future pandemics. It is a debate that has implications for clinical laboratories. After all, if location tracking identifies individuals who may have been […] (Source: Dark Daily)
Source: Dark Daily - April 24, 2020 Category: Laboratory Medicine Authors: Jude Tags: Digital Pathology Instruments & Equipment International Laboratory News Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operation Source Type: news

Drive-Through Coronavirus Testing Spreads across 30 States, Lowering Risk of Exposure to Phlebotomists and Clinical Laboratory Professionals
Prior to the SARS-CoV-2 pandemic, large-scale collection of medical laboratory specimens from patients sitting in their cars was an untried concept. That is no longer true. As of today, residents who meet certain criteria for exposure to SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—can now have their biological specimens collected at drive-through testing centers […] (Source: Dark Daily)
Source: Dark Daily - April 22, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment Laboratory Instruments & Laboratory Equipment Laboratory Management and Operations Laboratory News Laboratory Operations Laboratory Pathology Source Type: news

Serological Antibody Tests a ‘Potential Game Changer’ and Next Phase in Efforts to Combat the Spread of COVID-19 That Give Clinical Laboratories an Essential Role
IVD Companies and medical laboratories are developing serological survey testing that will enable them to determine how widespread COVID-19 has become While medical laboratories gear up for testing to detect SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—efforts also are underway for expanded use of serological tests that can detect whether an individual’s immune systems […] (Source: Dark Daily)
Source: Dark Daily - April 20, 2020 Category: Laboratory Medicine Authors: Jude Tags: Instruments & Equipment International Laboratory News Laboratory Management and Operations Laboratory Operations Laboratory Pathology Laboratory Testing Management & Operations anatomic pathology Cellex Inc. clinical laboratory clinica Source Type: news