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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Flu Season Brings Shut Down of Elective Surgeries and Procedures in United Kingdom’s National Health Service Hospitals

Mounting financial and patient-care problems in UK show NHS may not provide a quality blueprint for fixing US healthcare system flaws

Patients scheduled for elective surgeries—such as hip replacements or penciled in for routine outpatient appointments—have been turned away this winter from National Health Service (NHS) hospitals as the United Kingdom’s (UK’s) public healthcare system suffers another care emergency.

This latest crisis in the UK should provide further evidence to anatomic pathologists and medical laboratory leaders that the United States healthcare system is not alone in facing mounting financial and patient care questions. While an NHS-like single-payer healthcare system in the US is the goal of many reformers, the UK’s current crisis indicates such a system has serious flaws.

UK News Organizations Disagree with Government Leaders as to Cause of Crisis

NHS officials estimate as many as 55,000 elective operations and outpatient procedures were cancelled as hospitals attempted to free up capacity for the sickest patients. The Telegraph reported that the bed shortfall is blamed on a spike in winter flu, with budget cuts to social services for home healthcare, staff shortages, and an aging population further pressuring the healthcare system.

In late January, the NHS’ National Emergency Pressure Panel (NEPP) announced that planned operations, such as elective surgeries, that had been “suspended because of pressure on the NHS in January,” would be able to resume in February, Sky News reported.

Meanwhile, in response to the original decision in January to have hospitals stop performing elective surgeries and similar procedures, an editorial in The Guardian challenged Prime Minister Theresa May’s suggestion that the current crisis was primarily due to the flu epidemic.

“This is not the flu: it is a system-wide crisis brought about by seven years of mounting austerity,” The Guardian’s editors wrote. “Oh, and that is getting worse, too. The official defense is that this is not a crisis because there is a plan … But planning can’t magic up highly trained doctors and nurses. Plans do not make hospital beds. And while vaccination helps, you can’t entirely plan your way out of the impact of flu.”

Doctors Report ‘Intolerable Conditions’ at 68 Hospitals

The crisis reached new heights when specialists in emergency medicine from 68 hospitals sent a letter to the prime minister stating the “current level of safety compromise is at times intolerable, despite the best efforts of staff.” The letter, published in The Guardian, also pointed out media coverage reporting anecdotal accounts of “appalling” situations in many emergency departments “are not outliers.” According the doctors, conditions include:

  • Over 120 patients a day managed in corridors, some dying prematurely;
  • An average of 10-12 hours from decision to admit a patient until they are transferred to a bed;
  • Over 50 patients at a time awaiting beds in the emergency department; and,
  • Patients sleeping in clinics as makeshift wards.

One doctor, Richard Fawcett, MD, drew media attention when he used Twitter to apologized for “third world conditions” caused by overcrowding in the hospital where he works, The Telegraph reported.

Richard Fawcett, MD

Richard Fawcett, MD (above), a consultant in emergency medicine for University Hospitals of North Midlands NHS Trust, drew widespread media attention in England when he apologized to patients on Twitter for the “third world conditions” this winter at the hospital where he works. A Lieutenant Colonel in the British Royal Army, Fawcett has done three deployments to Afghanistan. (Photo copyright: Midlands Air Ambulance Charity.)

NHS officials acknowledged staff criticism but attempted to paint the crisis as temporary. University of North Midlands NHS Trust (UHNM) told BBC News that area hospitals had been under “severe and sustained pressure over the Christmas period,” which had “continued into the new year.”

“Our staff want the very best for our patients and at times they find the situation frustrating, which can be reflected on social media. However, we are a leading trauma, stroke, and cardiac center and have been regularly praised by external independent commentators for the quality of compassionate care provided at our hospitals despite all our pressures,” Dr. John Oxtoby, Consultant Radiologist and Deputy Medical Director, UHNM, told BBC News.

“We have to keep going and turn up in a fit state to do the best job that we can. But it’s been really tough, particularly on more junior staff,” one hospital staff member told The Guardian. “And when they ask me, ‘Will it always be like this and will it get better?’ I cannot say it will improve as the truth is it won’t unless the NHS gets the resources and investment it needs.”

Basic Elements of Care Neglected

This is not the first time the NHS has come under fire for substandard patient care.

Between 400 and 1,200 patients are estimated to have died as result of poor care between January 2005 and March 2008 at Stafford Hospital, reported The Guardian. A 2010 report into care at the hospital, now named County Hospital and run by UHNM, found a litany of problems.

“For many patients, the most basic elements of care were neglected,” inquiry Chairman Sir Robert Francis, QC, told The Guardian. “Some patients needing pain relief either got it late or not at all. Others were left unwashed for up to a month … The standards of hygiene were at times awful, with families forced to remove used bandages and dressings from public areas and clean toilets themselves for fear of catching infections.”

Reports of substandard patient care within the United Kingdom’s National Health Service are not new. British barrister Sir Robert Francis, QC (above), led investigations into the Stafford Hospital scandal, which uncovered that an estimated 400 to 1200 patients died between 2005 and 2008 at the facility due to appalling conditions and lax procedures. (Photo copyright: The Telegraph.)

Why not this crisis in US? Because, even if our system of healthcare has flaws, it is responsive to consumer/patient demand. Whereas, in the UK, the NHS is always budget short and so is always struggling to invest in expanding hospital/physician capacity to meet the steady increase in patient demand.

Dark Daily’s goal in reporting on this story is to help anatomic pathologists and clinical laboratory leaders in the United States understand that every country’s health system—like ours—has its share of unique problems and is not perfect.

—Andrea Downing Peck

Related Information:

NHS Patients Dying in Hospital Corridors, A/E Doctors Tell Theresa May

The Guardian View on the Crisis: It’s Not Just the Flu

Mid Staffs Hospital Scandal: The Essential Guide

NHS Crisis: ‘I Live in Fear I’ll Miss a Seriously Ill Patient and They Will Die’

Hospitals to Delay Non-Urgent Operations

NHS to Lift Suspension of Elective Surgery as Hospital Pressures ‘Ease’

Technologies on IBM’s 5-in-5 List Could Impact Pathology and Clinical Laboratories

This year, one of IBM’s closely-watched picks of the technologies most likely to have the greatest impact on society is the medical lab-on-a-chip

Clinical laboratory testing and diagnostics are one of the five technologies included in IBM’s 2017 list of the technologies it predicts will have the greatest impact on society during the next five years. Of equal interest to medical laboratory professionals is that several of the other technologies included in IBM’s list have the potential be used in medical laboratories and anatomic pathology groups.

IBM Research, corporate research laboratory for parent company IBM (NYSE:IBM), has more than 3,000 researchers working in 12 labs on six continents. Each year the lab releases a list of five technologies it forecasts will have the greatest influence on how our bodies, minds, society, and the planet, develop over the next five years. The list is called “5-in-5” and has been released annually for the past 10 years by the tech giant. (more…)

Cue’s Smartphone Device Intended to Give Consumers an Inexpensive Way to Perform Certain Medical Laboratory Tests at Home

Company says it will offer five diagnostic tests that are useful to the public and some of these tests are among the highest volume tests performed by clinical labs

Heading to market is another device that works with a smartphone to provide consumers with a way to perform five popular medical laboratory tests. The product was developed by Cue, Inc., which describes itself as an entrepreneurial mobile diagnostics developer.

Cue is an at-home lab test device targeted at consumers. It will be priced at about $300, noted a report published by MobiHealthNews.

“We’re very interested in putting the power of the lab into the consumer’s hands in this new way,” said Clint Sever, Cue Cofounder and Chief Product Officer. However, pending Food and Drug Administration (FDA) clearance, Cue’s device is being presold under an “investigational exception” for $199, with promise of delivery in spring 2015.

Cue Allows Consumers to Perform Five Routine Lab Tests at Home 

Initially, Cue will perform tests for influenza; testosterone; vitamin D; C-reactive protein (a marker for inflammation); and luteinizing hormone (an indicator of a women’s fertility) But that is just for starters.

According to Ayub Khattak, Cue Cofounder and CEO, the company plans to add more medical lab tests in the future. “The large majority of tests you do in the [clinical] lab today, we want to give you access to in your home,” he declared.

Ayub Khattak (pictured above), Cue Cofounder and CEO, says the Cue device will initially preform five routine tests, but other lab tests will be available in the future, (Photo copyright Cue)

Ayub Khattak (pictured above), Cue Cofounder and CEO, says the Cue device will initially preform five routine tests, but other lab tests will be available in the future, (Photo copyright Cue)

In its blog about Cue, IEE Spectrum noted that the first five clinical laboratory tests the company designed to run on its device were selected because these are the most common tests run by labs and, therefore, are the most useful to the public. Sever and Khattak observed in the MobiHealthNews story that all of these tests—except the influenza test—are used in monitoring a patient’s condition and are done regularly.

Athletes and older men, for instance, want to keep tabs on their testosterone levels. People are interested in Vitamin D because it affects mood. Clinical laboratories perform 70-million Vitamin D yearly, according to Khattak. Inflammation is both a predictor of heart disease and a counter indicator for intense workouts, so if the tests indicated elevated C-reactive protein, a person may want to back off from exercise for a little while, he added. The test for luteinizing hormone tells a woman when she is likely to conceive.

The influenza test, on the other hand, allows parents or other caretakers to check for flu at home, similar to taking a child’s temperature. Sever emphasized that the flu test isn’t meant to replace a doctor visit. “It just gives you more information so you can have an informed conversation with your doctor,” he said.

How the Cue Device Works

The Cue device is about the size of a Rubik’s cube. The test cartridges are about the size of a matchbox. Each cartridge uses blood, saliva, or mucus samples to conduct home lab tests. Each cartridge contains microfluidic channels and the necessary reagents for the test to be performed.

When the cartridge is inserted, Cue prompts the user to collect a sample with the sample wand that is included with the device, explained the IEE Spectrum blog. The testosterone test requires a saliva specimen. The flu test uses a nasal swab, and the other tests require a drop of blood as the specimen.

Once the sample wand is inserted into the cartridge, the reagents combine with the sample inside the cartridge. A sensor then looks for the target molecule, such as testosterone or Vitamin D, and detects the quantity or level. Cue sends this information via Bluetooth to the user’s iPhone or Android smartphone. The smartphone app allows the user to track results over time, and offers suggestions for improving health status. For example, Sever said Cue might recommend specific foods or exercise to boost low testosterone level.

Can Cue Produce More Accurate Tests Than Clinical Laboratories?

Khattak can’t make claims about the accuracy of Cue’s technology because it hasn’t yet been cleared by the FDA, noted the MobiHealthNews story. But the devices inventors believe that Cue tests have the potential to be more accurate than those performed in clinical laboratories, because the human error factor is eliminated.

“What we’ve done is we simplified and automated the whole process,” explained Khattak. “So whereas a lab technician might have 10 steps and they might do 10 of them quite well, those little errors in each of the steps add up. And human error is the largest cause of variation and deviation from standard reproducible results… With us, it is one step. You add the sample, and then you get your results.”

Cue, a modular, Rubik-cube-sized device, uses simple microfluidic laboratory technology to perform five different medical laboratory tests that people routinely have done, including testosterone and vitamin D levels, inflammation, fertility and influenza. The device is being presold under an investigational exception to consumers for $199, with promise of delivery in spring 2015. Once approved by the FDA, the price will be $300. (Photo copyright Cue)

Cue, a modular, Rubik-cube-sized device, uses simple microfluidic laboratory technology to perform five different medical laboratory tests that people routinely have done, including testosterone and vitamin D levels, inflammation, fertility and influenza. The device is being presold under an investigational exception to consumers for $199, with promise of delivery in spring 2015. Once approved by the FDA, the price will be $300. (Photo copyright Cue)

Investors are Successful Tech Entrepreneurs and Diagnostics Experts

Clinical laboratory managers might find it interesting that Cue investors are successful entrepreneurs with expertise in both diagnostics and digital technologies. The investor group includes two University of California, Los Angeles (UCLA) professors, as well as an anonymous private investor, noted MobiHealthNews.

One of the UCLA professors is Aydogan Ozcan, Ph.D., who heads up UCLA Engineering’s Bio- and Nano-Photonics Laboratory. His private company, Holomic, also develops smartphone diagnostic devices. Dark Daily has written about Ozcan’s work. (See Dark Daily, “Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology,” June 25, 2010.)

The other founder is Patrick Soon-Shiong, M.D., a former UCLA Medical Professor, who currently serves on the advisory board of UCLA Engineering’s Institute for Technology Advancement. Known as “LA’s billionaire doctor,” Soon-Shiong, a surgeon-turned-entrepreneur, is co-inventor on more than 40 U.S. and foreign patents and has sold two successful businesses for $8.5 billion.

Last year, Soon-Shiong launched Los Angeles-based Nantworks, LLC, a company that aims to revolutionize medicine by adding “Big Data” to patient care. Soon-Shiong also serves as Providence Health & Services’ Director for Cancer Services and Bioinformatics.

Will Consumers Pay for a Device that Does Medical Lab Tests at Home?

Will consumers be willing to pay $199 for a medical laboratory testing device that hooks up to their smartphone or tablet PC? The founders of Cue will find out next year, assuming that FDA clearance is forthcoming and the device reaches the market. Also, will Cue perform medical lab tests with accuracy that is comparable with that of the nation’s best clinical laboratories? There are many pathologists and lab scientists who will be prepared to challenge that statement.

—By Patricia Kirk

Related Information:

Cue to offer at-home, smartphone connected lab tests

New Gadget Gives Consumers At-Home Lab Tests

New iPhone App Allows Consumers to Test Their Urine on the Go for as Many as 25 Different Diseases

Tiny, Simple-to-Use Lensless Microscope Might Soon Find a Place in Pathology

Meet the Nation’s Top 10 Healthcare Systems for Quality

Advanced use of EHRs is one characteristic of nation’s quality leaders

It’s a new study and ranking of top-performing health systems that Dark Daily readers will find interesting and useful. Thomson Reuters announced its latest Top 10 rankings, and identified three main ingredients for attaining higher-quality outcomes. They were: 1) a corporate-level coordinating committee; 2) ample involvement in planning from front-line caregivers; and a system-wide electronic health record system (EHR).

Thomson-Reuters evaluated 252 health systems, representing 1,720 hospitals. Its findings were published exclusively in Modern Healthcare. Its rating was based on five clinical performance measures: mortality, complications, patient safety, length-of-stay and use of evidence-based medicine. No attempt was made to measure financial performance. The health systems study used 2007 information from two public databases, the Medicare Provider Analysis and Review and Center for Medicare and Medicaid Services’ Hospital Compare.
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CDC Data Shows Why Clinical Labs Continue to Identify Cases of A/H1N1 Flu

Clinical labs continue see higher-than-normal flu activity in what is typically the off-season

New cases of A/novel H1N1 continue to show up in the United States and worldwide. It means that influenza activity at clinical laboratories is higher than normal for this time of year. These continuing influenza cases affirm why public health officials expect a busy flu season this fall and winter.

In fact, data from the federal Centers for Disease Control and Prevention (CDC) show that overall influenza activity decreased in the United States in recent weeks compared to late April and early May. At the same time, the novel A/H1N1 flu has spawned a second flu season this year, extending into the summer months of 2009.

(more…)

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