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Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Medical Laboratories Need to Prepare as Public Health Officials Deal with Latest Coronavirus Outbreak

The CDC has developed a test kit, but deployment to public health laboratories has been delayed by a manufacturing defect

Medical laboratories are on the diagnostic front lines of efforts in the US to contain the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for the disease COVID-19, which was first reported in Wuhan City, China. SARS-CoV-2 differs from severe acute respiratory syndrome coronavirus (SARS-CoV), which caused an outbreak of severe acute respiratory syndrome (SARS) in 2003.

Currently, all testing for SARS-CoV-2 in the US is performed by the Centers for Disease Control and Prevention (CDC), using a CDC-developed rapid test known as the 2019-nCoV Real-Time RT-PCR Diagnostic Panel. But soon, testing will be performed by city and state public health (reference) laboratories as well.

At present, medical laboratories are collecting blood specimens for testing by authorized public health labs. However, clinical laboratories should prepare for the likelihood they will be called on to perform the testing using the CDC test or other tests under development.

“We need to be vigilant and understand everything related to the testing and the virus,” said Bodhraj Acharya, PhD, Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York, in an exclusive interview with Dark Daily. “If the situation comes that you have to do the testing, you have to be ready for it.”

The CDC has set up a website with information about SARS-CoV-2 (COVID-19) including a section specifically for laboratory professionals. The “Information for Health Departments on Reporting a Person Under Investigation (PUI) or Laboratory-Confirmed Case for COVID-19” section includes guidelines for collecting, handling, and shipping specimens. It also has laboratory biosafety guidelines.

The current criteria for determining PUIs include clinical features, such as fever or signs of lower respiratory illness, combined with epidemiological risks, such as recent travel to China or close contact with a laboratory-confirmed COVID-19 patient. The CDC notes that “criteria are subject to change as additional information becomes available” and advises healthcare providers to consult with state or local health departments if they believe a patient meets the criteria.

Bodhraj Acharya, PhD (above), is Manager of Chemistry and Referral Testing at the Laboratory Alliance of Central New York. In an exclusive interview with Dark Daily, he stressed the importance that medical laboratories be prepared. “We need to be vigilant and be active and understand everything related to this virus and the testing. That’s the role of clinical laboratory scientists, to be ready because this can become a pandemic anytime. It can spread and tomorrow the CDC could announce it is disseminating the test to designated laboratories.” (Photo copyright: Laboratory Alliance of Central New York.)

Test Kit Problems Delay Diagnoses

On Feb. 4, the FDA issued a Novel Coronavirus Emergency Use Authorization (EUA) allowing state and city public health laboratories, as well as Department of Defense (DoD) labs, to perform presumptive qualitative testing using the Real-Time Reverse Transcriptase PCR (RT-PCR) diagnostic panel developed by the CDC. Two days later, the CDC began distributing the test kits, a CDC statement announced. Each kit could test 700 to 800 patients, the CDC said, and could provide results from respiratory specimens in four hours.

However, on Feb. 12, the agency revealed in a telebriefing that manufacturing problems with one of the reagents had caused state laboratories to get “inconclusive laboratory results” when performing the test.

“When the state receives these test kits, their procedure is to do quality control themselves in their own laboratories,” said Nancy Messonnier, MD, Director of the CDC National Center for Immunization and Respiratory Diseases (NCIRD), during the telebriefing. “Again, that is part of the normal procedures, but in doing it, some of the states identified some inconclusive laboratory results. We are working closely with them to correct the issues and as we’ve said all along, speed is important, but equally or more important in this situation is making sure that the laboratory results are correct.”

During a follow-up telebriefing on Feb. 14, Messonnier said that the CDC “is reformulating those reagents, and we are moving quickly to get those back out to our labs at the state and local public health labs.”

Above is a picture of CDC’s laboratory test kit for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). CDC is shipping the test kits to laboratories CDC has designated as qualified, including US state and local public health laboratories, Department of Defense (DOD) laboratories, and select international laboratories. The test kits are bolstering global laboratory capacity for detecting SARS-CoV-2. (Photo and caption copyright: Centers for Disease Control and Prevention.)

Serologic Test Under Development

The current test has to be performed after a patient shows symptoms. The “outer bound” of the virus’ incubation period is 14 days, meaning “we expect someone who is infected to have symptoms some time during those 14 days,” Messonnier said. Testing too early could “produce a negative result,” she continued, because “the virus hasn’t established itself sufficiently in the system to be detected.”

Messonnier added that the agency plans to develop a serologic test that will identify people who were exposed to the virus and developed an immune response without getting sick. This will help determine how widespread it is and whether people are “seroconverting,” she said. To formulate this test, “we need to wait to draw specimens from US patients over a period of time. Once they have all of the appropriate specimens collected, I understand that it’s a matter of several weeks” before the serologic test will be ready, she concluded.

“Based on what we know now, we believe this virus spreads mainly from person to person among close contacts, which is defined [as] about six feet,” Messonnier said at the follow-up telebriefing. Transmission is primarily “through respiratory droplets produced when an infected person coughs or sneezes. People are thought to be the most contagious when they’re most symptomatic. That’s when they’re the sickest.” However, “some spread may happen before people show symptoms,” she said.

The virus can also spread when people touch contaminated surfaces and then touch their eyes, nose, or mouth. But it “does not last long on surfaces,” she said.

Where the Infection Began

SARS-CoV-2 was first identified during an outbreak in Wuhan, China, in December 2019. Soon thereafter, hospitals in the region “were overwhelmed” with cases of pneumonia, Dr. Acharya explained, but authorities could not trace the disease to a known pathogen. “Every time a new pathogen originates, or a current pathogen mutates into a new form, there are no molecular tests available to diagnose it,” he said.

So, genetic laboratories used next-generation sequencing, specifically unbiased nontargeted metagenomic RNA sequencing (UMERS), followed by phylogenetic analysis of nucleic acids derived from the hosts. “This approach does not require a prior knowledge of the expected pathogen,” Dr. Acharya explained. Instead, by understanding the virus’ genetic makeup, pathology laboratories could see how closely it was related to other known pathogens. They were able to identify it as a Betacoronavirus (Beta-CoVs), the family that also includes the viruses that cause SARS and Middle East Respiratory Syndrome (MERS).

This is a fast-moving story and medical laboratory leaders are advised to monitor the CDC website for continuing updates, as well as a website set up by WHO to provide technical guidance for labs.

—Stephen Beale

Related Information:

CDC Tests for COVID-19

CDC: Information for Laboratories

About Coronavirus Disease 2019 (COVID-19)

Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus

Coronavirus Disease (COVID-19) Outbreak

Coronavirus Disease (COVID-19) Technical Guidance: Laboratory Testing for 2019-nCoV in Humans

Novel Coronavirus Lab Protocols and Responses: Next Steps

WHO: China Leaders Discuss Next Steps in Battle Against Coronavirus Outbreak

Transcript for CDC Telebriefing: CDC Update on Novel Coronavirus February 12

Transcript for CDC Media Telebriefing: Update on COVID-19 February 14

Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins

Anatomic Pathologists Who Work in Independent Reference Laboratories Can Now Provide Diagnostic Services for CLIA-Approved Hospitals without Need for Additional Credentialing and Privileging

The Joint Commission’s recent alteration to the Introduction to Leadership (LD) Standard LD.04.03.09 makes it easier for off-site and independent reference laboratories to service CLIA-hospitals and other CLIA-approved healthcare facilities

Anatomic pathologists working for reference laboratories can now provide diagnostic services to hospitals, critical-access hospitals, and ambulatory care facilities in the US based on the organization’s Clinical Laboratory Improvement Amendments (CLIA) status, rather than the usual credentialing and privileging. The Joint Commission (TJC) made the change effective January 2018.

According to a TJC press release, “Clinical Laboratory Improvement Amendments (CLIA) regulations 42 CFR 493.1351 through 493.1495 outline specific and rigorous competency requirements for laboratory personnel, including requirements for pathology services and its subspecialties. But because pathologists practicing in the US are required to comply with these requirements, Joint Commission-accredited organizations that seek the services of pathologists within independent reference laboratories (that comply with CLIA regulations) can safely presume that the pathologists are qualified and competent to perform all diagnostic services within their pathology practice—thus making an additional credentialing and privileging process unnecessary.”

In an interview with Dark Daily, Heather Hurley, Executive Director, The Joint Commission, and Ron Quicho, Associate Project Director and Standards Development Director at TJC, explained the reasons behind this change. “With the current CLIA requirements, the previous standard was adding unnecessary burdens and regulatory overhead to hospitals and ambulatory care organizations—especially as outsourcing continues to increase within the testing market. This update helps to reduce these burdens and streamline testing,” Hurley noted.

Quicho added, “The Joint Commission continually evaluates its standards and survey process to ensure that we are providing an accreditation service that is of the highest quality and value. That said, we made the decision to update the standards based on feedback from stakeholders and customers.”


Ron Quicho, Associate Project Director and Standards Development Director (left), and Heather Hurley, Executive Director (right), The Joint Commission, believe these updated standards will benefit clinical laboratories and hospitals alike. But they note, “Anytime the pathologist provides professional services and consultation in the same laboratory where the specimen was collected or prepared, credentialing and privileging would be required. The exception for credentialing and privileging only applies when pathology services are provided off-site, such as at a reference laboratory.” (Photo copyrights: LinkedIn/The Joint Commission.)

Joint Commission Reduces ‘Unnecessary Burden’ on Hospitals, Ambulatory Care Facilities

Reference testing and CLIA have been a common part of the diagnostics and medical laboratory landscape for decades. According to Quicho, the key components of The Joint Commission’s decision include:

  • Increasing numbers of independent practitioners and consultants;
  • Reference laboratories often seek pathology services from another laboratory for certain testing and screening. As such, it is unclear if the credentialing and privileging requirements extend to these secondary pathology services, since they may also be providing the interpretation;
  • It would be virtually impossible to credential and privilege all pathologists at a reference laboratory whose services result in patient care decisions, since interpretations are made not only in anatomical (surgical) pathology but in many areas of clinical pathology; and,
  • Reference laboratories employ hundreds of pathologists and healthcare facilities and cannot be sure of who provides interpretation on specimens that are sent out.

It is important to understand that the exclusions in this latest TJC update only apply when testing is performed offsite of the ordering facility. In their press release, TJC stated, “A reference laboratory is a laboratory contracted for testing that is owned and operated by an organization other than the organization referring the testing … When the pathologist provides his or her professional service, including consultation in the same laboratory or organization where the specimen was collected or prepared, credentialing and privileging is required.”

TJC Change Helps Clinical Laboratories and Hospitals Alike

Hurley points out that the January 2018 edition of TJC’s “Comprehensive Accreditation Manuals” already includes the updated standard and that participating ambulatory care, critical access hospitals, and hospitals were updated regarding the changes. The 2018 print editions will also include this change.

She also points out that exclusion from the standard’s requirements does not prevent hospitals from still requiring credentialing or privileging for their internal compliance processes or regulations. Quicho also emphasizes the importance of continuing to meet all CLIA requirements surrounding competencies, training, and personnel qualifications.

The TJC update should result in less action required by both clinical laboratories and hospitals alike—a welcome change for a market in a state of near-constant flux due to healthcare reform and increased regulation. The reasoning behind the decision also highlights current trends amongst pathology groups and clinical laboratories concerning scaling through consolidation and outsourcing among hospitals, ambulatory care organizations, and critical care providers.

—Jon Stone

Related Information:

Now in Effect: Change to Requirements for Credentialing, Privileging of Independent Pathologists

Credentialing and Privileging of Independent Pathologists

The Joint Commission No Longer Requires Credentialing and Privileging of Independent Pathologists—Four Things to Know

National Clinical Lab Sales Excellence Award Winner in Seattle Leverages Cooperation between Sales and Operations to Win New Clients, Revenue

PACLAB’s effective use of clinical laboratory sales reps demonstrates how effective collaboration between sales and operations can help an outreach lab increase specimen volume and expand its market share

Despite falling prices for clinical laboratory testing and payers increasingly excluding labs from their provide networks, savvy hospitals and health systems continue to enjoy profitable laboratory outreach programs. One common factor shared by these successful hospital lab outreach businesses is that they support productive lab sales representatives.

To tell the story of how effective lab sales reps contribute to the ongoing success of the hospital lab outreach programs they serve, The Dark Report initiated the clinical lab industry’s first-ever program of national recognition for top-performing lab sales representatives. These awards were launched in May 2016, at the 21st Annual Executive War College on Laboratory and Pathology Management (EWC). At that time, The Dark Report also announced the first winners of the National Lab Sales Excellence Awards contest. (more…)

Mobile Medical Laboratory Brings High-Complexity Infectious Disease Testing to South Africa’s Remote Regions

Immediate access to TB and HIV testing means faster diagnosis and treatment for patients in remote areas

Use of a new mobile medical laboratory is boosting access to quality diagnostic testing for patients in remote areas of South Africa, while slashing turnaround times and courier costs. This German-built mobile clinical laboratory performs high complexity testing and may provide a new model for diagnostic testing for other developing countries.

Fraunhofer Institute for Biomedical Engineering (IBMT) in Saarland, Germany, built the $2 million mobile medical laboratory in collaboration with the government of the Western Cape, a province in southwest South Africa.

The clinical lab-on-wheels operates as an extension of the Caledon Hospital. This is a 75-bed community hospital located in the Overberg district, about 62 miles east of Cape Town. Specimens are sent to the mobile laboratory from health facilities in the surrounding area.


PAML & Providence Health Announce Clinical Pathology Laboratory Joint Venture in California

Hospital lab—commercial medical laboratory collaboration will launch in San Fernando Valley

Yesterday, Pathology Associates Medical Laboratories (PAML) announced a new clinical pathology laboratory joint venture (JV) that is likely to create a tough new laboratory competitor in Southern California.

Spokane, Washington-based PAML and Renton, Washington-based Providence Health & Services will create a new medical laboratory services company to serve California’s San Fernando Valley and its surrounding communities. The new company will begin operating early in 2011 and will be called California Laboratory Associates (CLA), LLC. CLA will provide routine laboratory testing services to medical practices and hospitals from the recently remodeled labs at Providence Saint Joseph Medical Center in Burbank, and more specialized reference and esoteric testing from PAML’s laboratory in Washington.