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A Tale of Two Countries: As the US Ramps Up Medical Laboratory Tests for COVID-19, the United Kingdom Falls Short

Apr 17, 2020 | Laboratory Pathology

Media reports in the United Kingdom cite bad timing and centralization of public health laboratories as reasons the UK is struggling to meet testing goals

Clinical pathologists and medical laboratories in UK and the US function within radically different healthcare systems. However, both countries faced similar problems deploying widespread diagnostic testing for SARS-CoV-2, the novel coronavirus that causes COVID-19. And the differences between America’s private healthcare system and the UK’s government-run, single-payer system are exacerbating the UK’s difficulties expanding coronavirus testing to its citizens.

The Dark Daily reported in March that a manufacturing snafu had delayed distribution of a CDC-developed diagnostic test to public health laboratories. This meant virtually all testing had to be performed at the CDC, which further slowed testing. Only later that month was the US able to significantly ramp up its testing capacity, according to data from the COVID Tracking Project.

However, the UK has fared even worse, trailing Germany, the US, and other countries, according to reports in Buzzfeed and other media outlets. On March 11, the UK government established a goal of administering 10,000 COVID-19 tests per day by late March, but fell far short of that mark, The Guardian reported. The UK government now aims to increase this to 25,000 tests per day by late April.

This compares with about 70,000 COVID-19 tests per day in Germany, the Guardian reported, and about 130,000 per day in the US (between March 26 and April 14), according to the COVID Tracking Project.

“Ministers need to explain why the NHS [National Health Service] is not testing to capacity, why we are falling behind other countries, and what measures they will put in place to address this situation as a matter of urgency,” MP Keir Starmer (above) said in Parliament in late March, The Guardian reported. (Photo copyright: The Guardian.)

What’s Behind the UK’s Lackluster COVID-19 Testing Response

In January, when the outbreak first hit, Public Health England (PHE) “began a strict program of contact tracing and testing potential cases,” Buzzfeed reported. But due to limited medical laboratory capacity and low supplies of COVID-19 test kits, the government changed course and de-emphasized testing, instead focusing on increased ICU and ventilator capacity. (Scotland, Wales, and Northern Ireland each have separate public health agencies and national health services.)

Later, when the need for more COVID-19 testing became apparent, UK pathology laboratories had to contend with global shortages of testing kits and chemicals, The Guardian reported. At present, COVID-19 testing is limited to healthcare workers and patients displaying symptoms of pneumonia, acute respiratory distress syndrome, or influenza-like illness, PHE stated in “COVID-19: Investigation and Initial Clinical Management of Possible Cases” guidance.

Another factor that has limited widespread COVID-19 testing is the country’s highly-centralized system of public health laboratories, Buzzfeed reported. “This has limited its ability to scale and process results at the same speed as other countries, despite its efforts to ramp up capacity,” Buzzfeed reported. Public Health England, which initially performed COVID-19 testing at one lab, has expanded to 12 labs. NHS laboratories also are testing for the SARS-CoV-2 coronavirus, PHE stated in “COVID-19: How to Arrange Laboratory Testing” guidance.

Sharon Peacock, PhD, PHE’s National Infection Service Interim Director, Professor of Public Health and Microbiology at the University of Cambridge, and honorary consultant microbiologist at the Cambridge clinical and public health laboratory based at Addenbrookes Hospital, defended this approach at a March hearing of the Science and Technology Committee (Commons) in Parliament.

“Laboratories in this country have largely been merged, so we have a smaller number of larger [medical] laboratories,” she said. “The alternative is to have a single large testing site. From my perspective, it is more efficient to have a bigger testing site than dissipating our efforts into a lot of laboratories around the country.”

Writing in The Guardian, Paul Hunter, MB ChB MD, a microbiologist and Professor of Medicine at University of East Anglia, cites historic factors behind the testing issue. The public health labs, he explained, were established in 1946 as part of the National Health Service. At the time, they were part of the country’s defense against bacteriological warfare. They became part of the UK’s Health Protection Agency (now PHE) in 2003. “Many of the laboratories in the old network were shut down, taken over by local hospitals or merged into a smaller number of regional laboratories,” he wrote.

US Facing Different Clinical Laboratory Testing Problems

Meanwhile, a few medical laboratories in the US are now contending with a different problem: Unused testing capacity, Nature reported. For example, the Broad Institute of MIT and Harvard in Cambridge, Mass., can run up to 2,000 tests per day, “but we aren’t doing that many,” Stacey Gabriel, PhD, a human geneticist and Senior Director of the Genomics Platform at the Broad Institute, told Nature. Factors include supply shortages and incompatibility between electronic health record (EHR) systems at hospitals and academic labs, Nature reported.

Politico cited the CDC’s narrow testing criteria, and a lack of supplies for collecting and analyzing patient samples—such as swabs and personal protective equipment—as reasons for the slowdown in testing at some clinical laboratories in the US.

Challenges Deploying Antibody Tests in UK

The UK has also had problems deploying serology tests designed to detect whether people have developed antibodies against the virus. In late March, Peacock told members of Parliament that at-home test kits for COVID-19 would be available to the public through Amazon and retail pharmacy chains, the Independent reported. And, Politico reported that the government had ordered 3.5 million at-home test kits for COVID-19.

However, researchers at the University of Oxford who had been charged with validating the accuracy of the kits, reported on April 5 that the tests had not performed well and did not meet criteria established by the UK Medicines and Healthcare products Regulatory Agency (MHRA). “We see many false negatives (tests where no antibody is detected despite the fact we know it is there), and we also see false positives,” wrote Professor Sir John Bell, GBE, FRS, Professor of Medicine at the university, in a blog post. No test [for COVID-19], he wrote, “has been acclaimed by health authorities as having the necessary characteristics for screening people accurately for protective immunity.”

He added that it would be “at least a month” before suppliers could develop an acceptable COVID-19 test.

Meanwhile, in the US, on April 1 the FDA issued an Emergency Use Authorization (EUA) for the qSARS-CoV-2 IgG/IgM Rapid Test developed by Cellex Inc. in N.C., the Washington Times reported. Cellex reported that its test had a 93.75% positive agreement with a PCR (polymerase chain reaction) test and a 96.4% negative agreement with samples collected before September 2019.

In the United States, the Cellex COVID-19 test is intended for use by medical laboratories. As well, many research sites, academic medical centers, clinical laboratories, and in vitro diagnostics (IVD) companies in the US are working to develop and validate serological tests for COVID-19.

Within weeks, it is expected that a growing number of such tests will qualify for a Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and become available for use in patient care.

—Stephen Beale

Related Information:

Why the UK Failed to Get Coronavirus Testing Up to Speed

Even the US Is Doing More Coronavirus Tests than the UK. Here Are the Reasons Why

Fall in Covid-19 Tests Putting Lives at Risk, Critics Claim

UK Ministers Accused of Overstating Scale of Coronavirus Testing

Coronavirus: Government Sets Target for 100,000 Tests Per Day by End of Month

Coronavirus Test: UK To Make 15-Minute At-Home Kits Available ‘Within Days’

Coronavirus: Can I Get a Home Testing Kit and What Is an Antibody Test?

Covid-19 Testing in the UK: Unpicking the Lockdown

Current COVID-19 Antibody Tests Aren’t Accurate Enough for Mass Screening, Say Oxford Researchers

Thousands of Coronavirus Tests Are Going Unused in US Labs

Exclusive: The Strongest Evidence Yet That America Is Botching Coronavirus Testing

Coronavirus Testing Hits Dramatic Slowdown in US

Coronavirus Testing Is Starting to Get Better—But It Has a Long Way to Go

Was It Flu or the Coronavirus? FDA Authorizes First COVID-19 Antibody Test

Medical Laboratories Need to Prepare as Public Health Officials Deal with Latest Coronavirus Outbreak

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

Mar 14, 2018 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations

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’

United Kingdom Doctors Call for an End to 10-Minute Office Visits and a Cap on Number of Patients They See

Nov 28, 2016 | Laboratory Pathology, Laboratory Testing, Management & Operations

Aging population and funding challenges could cause doctors in United States to shorten appointment slots for patients here as well

Across the globe, health systems share a common challenge: how to meet the steady increase in the number of patients demanding access to clinical care with a workforce of physicians, nurses, and clinicians that may be shrinking due to retirements and other factors. Pathologists and clinical laboratory managers will want to stay alert to these developments, because this same trend is at work within the United States.

The United Kingdom (UK) offers a good example of this problem. Claiming doctors are being “run into the ground,” general practitioners in the UK are calling for an end to the country’s standard 10-minute office visit and a decrease in the number of patients they see per week.

The British Medical Association (BMA) blames general practitioner (GP) burnout on:

• Rising demand from an aging population with multiple health needs;

• Physician and staff shortage; and

• Inadequate federal government funding for healthcare.

Those factors also are at play within the United States (US) healthcare system. The possibility exists that health system administrators might want to create a standard of 10-minute appointment intervals as a norm for primary care physicians in this country. (more…)

National Health Service Reports that Most UK Hospitals Operating in Deficit Situations

Apr 4, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations

The National Health Service of England (NHS) ended 2014 with a budget overrun of £800 million, placing financial stress on the entire UK health system

According to a recently released report, nearly all hospitals in the United Kingdom are currently in financial stress. The report indicates that only seven of the 138 hospital trusts are profitable, with the remaining ones operating in a deficit situation.

Here in the United States, the UK’s National Health Service is often touted as an example of a successful single-payer health system. Thus, the extraordinary financial problems within the NHS offer pathologists and clinical laboratory managers in this country some insight into the serious challenges confronting the NHS, including increased demand for services, which puts additional stress on existing hospital budgets. (more…)

In the United Kingdom, Medical Laboratory Professionals Gather to Explore Disruptive Diagnostic Technology, ISO 15189, and How Labs Can Add Value

Jan 30, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily

Two-day conference attracted an international audience of clinical laboratory scientists and addressed major trends in healthcare and laboratory medicine

DATELINE: BIRMINGHAM, ENGLAND—This week in the industrial heartland of the United Kingdom, pathologists and medical laboratory professionals gathered for the 13th Annual Frontiers in Laboratory Medicine (FiLM) conference. The hot topics were new quality management standards for labs in the UK, innovative ways to improve utilization of clinical laboratory tests, and how first mover laboratories in the United Kingdom are using such disruptive technologies as digital pathology and MALDI-TOF mass spectrometry.

FiLM is co-produced annual by the Association for Clinical Biochemistry and The Dark Report. Over the past decade, it has grown into the largest conference in Europe that addresses the management and operation of medical laboratories and histopathology laboratories.

New Medical Laboratory Standards include ISO 15189

Currently, medical laboratories in the United Kingdom are adapting to changes in accreditation and external quality assurance (EQA—known as proficiency testing in the United States). By 2018, all labs in the UK will need to be accredited to the standards of ISO 15189: Medical Laboratories. As this happens, the United Kingdom will join a growing list of nations that now use ISO 15189 as a basis for licensure and accreditation of histopathology and medical laboratories. (more…)

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