Coronavirus Disease 2019 (COVID-19)

The information provided below is current as of May 14, 2020.

Under the guidance of the US Centers for Disease Control and Prevention (CDC), Aurora Diagnostics is closely monitoring the Coronavirus 2019 (COVID-19) outbreak caused by SARS-CoV-2. Our priority is the health and safety of our employees, patients, and the communities we serve. We encourage you to periodically check this webpage for updates.

COVID-19: Information for Healthcare Providers

Aurora Diagnostics, Seacoast Pathology and LMC Pathology are now performing COVID-19 Molecular (PCR) testing and can be collected with providers’ orders. It is important to note that our Practices cannot collect respiratory (e.g. nasopharyngeal swabs) specimens for individuals who believe they have COVID-19 and are symptomatic.

Providers should not refer any patients suspected (persons under investigation) or confirmed to be infected with COVID-19 to Seacoast Pathology or LMC Pathology.

The information below provides answers to frequently asked questions.

COVID-19: Information for Patients

Aurora Diagnostics is closely monitoring the situation regarding the 2019 Novel Coronavirus (COVID-19). We are dedicated to promoting a healthy and safe environment for all our patients and employees.

Updated press releases and media statements regarding our response to COVID-19 Testing are listed below.

SARS-CoV-2/COVID-19 Update for Health Plans (20 May 2020)

Tuesday 20 May 2020, 13:00 | Aurora Diagnostics
Update for Health Plans: New Pricing and CPT Code Information

Name of Test CPT Code Net Price (Expected Net Reimbursement)

Name of Test CPT Code Net Price (Expected Net Reimbursement)
SARS-CoV-2/COVID-19, High throughput NAAT U0004 $100.00

*Effective May 20, 2020, Sonic Healthcare USA Anatomic Pathology Division, Aurora Diagnostics, have begun performing Molecular (PCR) tests for COVID-19. In response to this national health crisis and to ensure optimal access for patients, we are offering a single price for all payers.

  • – As for all COVID-19 tests, Aurora uses multiple platforms and methodologies for molecular (PCR) testing in order to:
    • – maintain critical turnaround time commitment.
    • – prevent service interruptions due to platform-specific supply chain issues.
    • – resolve indeterminate results or inconsistencies between test results and clinical presentation.
  • – All tests have received Emergency Use Authorization (EUA) by the FDA.

For additional information, please use links given below:

The COVID-19 outbreak is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

COVID-19 FAQ

What are the clinical features of COVID-19?

The clinical spectrum of COVID-19 ranges from mild disease with non-specific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock. There have also been reports of asymptomatic infection with COVID-19. See also Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19).

Who is at risk for COVID-19?

Currently, those at greatest risk of infection are persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19 and those who live in or have recently been to areas with sustained transmission.

Who is at risk for severe disease from COVID-19?

The available data is currently insufficient to identify risk factors for severe clinical outcomes. From the limited data that is available for COVID-19 infected patients, and for data from related coronaviruses such as SARS-CoV and MERS-CoV, it is possible that older adults, and persons who have underlying chronic medical conditions, such as immunocompromising conditions, may be at risk for more severe outcomes. See also Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19).

When is someone infectious?

The onset and duration of viral shedding and period of infectiousness for COVID-19 are not yet known. It is possible that SARS-CoV-2 RNA may be detectable in the upper or lower respiratory tract for weeks after illness onset, similar to infection with MERS-CoV and SARS-CoV. However, detection of viral RNA does not necessarily mean that infectious virus is present. Asymptomatic infection with SARS-CoV-2 has been reported, but it is not yet known what role asymptomatic infection plays in transmission. Similarly, the role of pre-symptomatic transmission (infection detection during the incubation period prior to illness onset) is unknown. Existing literature regarding SARS-CoV-2 and other coronaviruses (e.g. MERS-CoV, SARS-CoV) suggest that the incubation period may range from 2–14 days.

Which body fluids can spread infection?

Very limited data is available about the detection of SARS-CoV-2 and infectious virus in clinical specimens. SARS-CoV-2 RNA has been detected from upper and lower respiratory tract specimens, and SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid. SARS-CoV-2 RNA has been detected in blood and stool specimens, but whether an infectious virus is present in extrapulmonary specimens is currently unknown. The duration of SARS-CoV-2 RNA detection in upper and lower respiratory tract specimens and in extrapulmonary specimens is not yet known but may be several weeks or longer, which has been observed in cases of MERS-CoV or SARS-CoV infection. While viable, infectious SARS-CoV has been isolated from respiratory, blood, urine, and stool specimens, in contrast – viable, infectious MERS-CoV has only been isolated from respiratory tract specimens. It is not yet known whether other non-respiratory body fluids from an infected person including vomit, urine, breast milk, or semen can contain viable, infectious SARS-CoV-2.

Can people who recover from COVID-19 be infected again?

The immune response to COVID-19 is not yet understood. Patients with MERS-CoV infection are unlikely to be re-infected shortly after they recover, but it is not yet known whether similar immune protection will be observed for patients with COVID-19.

How should healthcare personnel protect themselves when evaluating a patient who may have COVID-19?

Although the transmission dynamics have yet to be determined, CDC currently recommends a cautious approach to persons under investigation (PUI) for COVID-19. Healthcare personnel evaluating PUI or providing care for patients with confirmed COVID-19 should use, Standard Transmission-based Precautions. See the Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for Coronavirus Disease 2019 (COVID-19) in Healthcare Settings.

Should any diagnostic or therapeutic interventions be withheld due to concerns about transmission of COVID-19?

Patients should receive any interventions they would normally receive as standard of care. Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified and be evaluated in a private room with the door closed. Healthcare personnel entering the room should use Standard and Transmission-based Precautions.

Who should healthcare providers notify if they suspect a patient has COVID-19?

Healthcare providers should consult with local or state health departments to determine whether patients meet criteria for a Persons Under Investigation (PUI). Providers should immediately notify infection control personnel at their facility if they suspect COVID-19 in a patient.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants in-patient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. Some patients with an initial mild clinical presentation may worsen in the second week of illness. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis. This decision will depend not only on the clinical presentation, but also on the patient’s ability to engage in monitoring, the ability for safe isolation at home, and the risk of transmission in the patient’s home environment. For more information, see Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for Coronavirus Disease 2019 (COVID-19) in a Healthcare Setting and Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for Coronavirus Disease 2019 (COVID-19). More guidance about environmental infection control is available in section 7 of CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed COVID-19 or Persons Under Investigation for COVID-19 in Healthcare Settings.

MOLECULAR TESTING FAQ

What are the clinical features of COVID-19?

The clinical spectrum of COVID-19 ranges from mild disease with non-specific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock. There have also been reports of asymptomatic infection with COVID-19. See also Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19).

Who is at risk for COVID-19?

Currently, those at greatest risk of infection are persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19 and those who live in or have recently been to areas with sustained transmission.

Who is at risk for severe disease from COVID-19?

The available data is currently insufficient to identify risk factors for severe clinical outcomes. From the limited data that is available for COVID-19 infected patients, and for data from related coronaviruses such as SARS-CoV and MERS-CoV, it is possible that older adults, and persons who have underlying chronic medical conditions, such as immunocompromising conditions, may be at risk for more severe outcomes. See also Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease 2019 (COVID-19).

When is someone infectious?

The onset and duration of viral shedding and period of infectiousness for COVID-19 are not yet known. It is possible that SARS-CoV-2 RNA may be detectable in the upper or lower respiratory tract for weeks after illness onset, similar to infection with MERS-CoV and SARS-CoV. However, detection of viral RNA does not necessarily mean that infectious virus is present. Asymptomatic infection with SARS-CoV-2 has been reported, but it is not yet known what role asymptomatic infection plays in transmission. Similarly, the role of pre-symptomatic transmission (infection detection during the incubation period prior to illness onset) is unknown. Existing literature regarding SARS-CoV-2 and other coronaviruses (e.g. MERS-CoV, SARS-CoV) suggest that the incubation period may range from 2–14 days.

Which body fluids can spread infection?

Very limited data is available about the detection of SARS-CoV-2 and infectious virus in clinical specimens. SARS-CoV-2 RNA has been detected from upper and lower respiratory tract specimens, and SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid. SARS-CoV-2 RNA has been detected in blood and stool specimens, but whether an infectious virus is present in extrapulmonary specimens is currently unknown. The duration of SARS-CoV-2 RNA detection in upper and lower respiratory tract specimens and in extrapulmonary specimens is not yet known but may be several weeks or longer, which has been observed in cases of MERS-CoV or SARS-CoV infection. While viable, infectious SARS-CoV has been isolated from respiratory, blood, urine, and stool specimens, in contrast – viable, infectious MERS-CoV has only been isolated from respiratory tract specimens. It is not yet known whether other non-respiratory body fluids from an infected person including vomit, urine, breast milk, or semen can contain viable, infectious SARS-CoV-2.

Can people who recover from COVID-19 be infected again?

The immune response to COVID-19 is not yet understood. Patients with MERS-CoV infection are unlikely to be re-infected shortly after they recover, but it is not yet known whether similar immune protection will be observed for patients with COVID-19.

How should healthcare personnel protect themselves when evaluating a patient who may have COVID-19?

Although the transmission dynamics have yet to be determined, CDC currently recommends a cautious approach to persons under investigation (PUI) for COVID-19. Healthcare personnel evaluating PUI or providing care for patients with confirmed COVID-19 should use, Standard Transmission-based Precautions. See the Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for Coronavirus Disease 2019 (COVID-19) in Healthcare Settings.

Should any diagnostic or therapeutic interventions be withheld due to concerns about transmission of COVID-19?

Patients should receive any interventions they would normally receive as standard of care. Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified and be evaluated in a private room with the door closed. Healthcare personnel entering the room should use Standard and Transmission-based Precautions.

Who should healthcare providers notify if they suspect a patient has COVID-19?

Healthcare providers should consult with local or state health departments to determine whether patients meet criteria for a Persons Under Investigation (PUI). Providers should immediately notify infection control personnel at their facility if they suspect COVID-19 in a patient.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants in-patient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. Some patients with an initial mild clinical presentation may worsen in the second week of illness. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis. This decision will depend not only on the clinical presentation, but also on the patient’s ability to engage in monitoring, the ability for safe isolation at home, and the risk of transmission in the patient’s home environment. For more information, see Interim Infection Prevention and Control Recommendations for Patients with Known or Patients Under Investigation for Coronavirus Disease 2019 (COVID-19) in a Healthcare Setting and Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for Coronavirus Disease 2019 (COVID-19). More guidance about environmental infection control is available in section 7 of CDC’s Interim Infection Prevention and Control Recommendations for Patients with Confirmed COVID-19 or Persons Under Investigation for COVID-19 in Healthcare Settings.

GENERAL FAQS

What should I do if I am sick?

Call your doctor: If you think you have been exposed to COVID-19 and develop a fever and symptoms, such as cough or difficulty breathing, call your healthcare provider for medical advice. Steps If You're Sick

What precautions are applied if I have had "close contact" with a confirmed patient with COVID-19?

- The CDC defines “close contact” as (a) being within approximately 6 feet of a COVID-19 case for more than a few minutes; close contact can occur while caring for, living with, visiting, or sharing a health care waiting area or room with a COVID-19 case; OR (b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on).
- Any patient who has had “close contact” with a person confirmed to have, or being evaluated for, COVID-19 infection, should immediately seek care from a healthcare professional and/or notify their local health department.

MOLECULAR FAQS

What is Molecular (PCR) Testing for COVID-19?

Uses nucleic acid-amplification technology (e.g., PCR), which detects the genetic information and indicates active infection with the virus which causes COVID-19.

What does it mean if the specimen tests NEGATIVE for the virus that causes COVID-19?

A negative test result for this test means that SARS-CoV-2 RNA was not detected in the specimen. However, a negative result does not completely rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of any recent exposure and clinical signs or symptoms that may suggest COVID-19. The possibility of a false negative result should especially be considered if COVID-19 is clinically likely and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected, re-testing should be considered by healthcare providers in consultation with public health authorities.

What does it mean if the specimen tests POSITIVE for the virus that causes COVID-19?

A positive test result indicates that SARS-CoV-2 RNA was detected, and the patient is presumably infected with the virus and presumably contagious. Laboratory test results should be considered in the clinical and community context to establish a final diagnosis and care plan. Positive results do not rule out simultaneous bacterial infection or co-infection with other viruses. Patient management decisions should be made by a healthcare provider and should follow the current CDC guidelines. The COVID-19 test has been designed to minimize the likelihood of false-positive test results, but it may not be possible to completely exclude a false positive.

MEDIA

Sonic Healthcare USA Hosts U.S. Health and Human Services Secretary to Highlight Innovations in Response to the COVID-19 Pandemic

Sonic Healthcare USA's Bernhardt Laboratories, located in Jacksonville, Florida, hosted U.S. Health and Human Services Secretary Alex Azar at their facility last week. Bernhardt Laboratories is an anatomic pathology provider specializing in women's health, dermatopathology, and molecular pathology. Bernhardt Laboratories significantly changed its operations to mitigate supply chain challenges for Sonic Healthcare USA's COVID-19 testing initiative.

Over the last few months, Sonic Healthcare USA has been one of the leading commercial laboratories who, as a member of the American Clinical Laboratory Association (ACLA), has assisted in the response for COVID-19, in close coordination with the White House Coronavirus Task Force. Sonic Healthcare USA has also worked closely with our scientific experts and medical and operational leadership to bring up multiple platforms to ensure testing access for patients. As of March 10, 2020, Sonic Healthcare USA launched molecular testing for COVID-19 and is performing over twenty thousand tests per day at our clinical laboratories. On April 21, 2020, we launched COVID-19 antibody testing to complement our existing molecular PCR testing.

"It was an honor hosting Secretary Azar to discuss and showcase the strategies we have employed to ensure testing access and timely result delivery for our patients," said Dr. Phil Chen, MD, PhD, the Chief Strategy Officer and Head of the COVID-19 Taskforce at Sonic Healthcare USA. "Secretary Azar was very informative and gracious during his visit by offering us access to explore automated technologies and associated financial support, to further expand testing capacity," added Dr. Chen.

"It is incredibly important that we continue to partner with governmental agencies aligning resources and approaches as we manage through the COVID-19 pandemic together. We are grateful to Secretary Azar for his leadership and support," said Dr. Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA.

Sonic Healthcare USA Develops Novel Return-to-Work Protocol including Laboratory Testing Algorithms

Sonic Healthcare USA's COVID-19 Taskforce Medical and Scientific Advisors have developed a novel Return-to-Work protocol consisting of laboratory testing algorithms intended to help guide employers and worksite health practitioners with their strategies to return workers and optimize ongoing monitoring and prevention.

The algorithms are optimized for molecular PCR and serology testing performed at Sonic Healthcare USA's network of Clinical Laboratories. They are designed to be deployed in conjunction with vigorous social distancing policies, syndromic surveillance and ongoing, and self-reported exposure risk assessment. The protocol also integrates with the policies and procedures for COVID-19 workplace exposure, risk triage, and employee management established by the Advisors.

Sonic Healthcare USA's novel protocol consists of two main components:

- Initial screening of the workforce for active infection and establishment of baseline exposure status.
- Ongoing workplace surveillance to detect early infections, identify, and assess exposure risks.

The Return-to-Work protocol includes available consultations for our partners and clients who are looking to implement similar guidance based laboratory testing algorithms. The algorithms can be customized for specific worksite types and requirements.

"Our Return-to-Work protocol represents the depth of our collective medical and scientific expertise and real-world experience of our Advisors," said Phil Chen, MD, PhD, the Chief Strategy Officer and Head of the COVID-19 Taskforce at Sonic Healthcare USA. "Utilizing evidence-based data combined with an optimized laboratory testing strategy are critical components of this protocol, assisting our partners with their return-to-work and workforce assurance strategies," added Dr. Chen.

Sonic Healthcare USA will continue to update its laboratory testing algorithms to accommodate the most recent medical and scientific evidence, new testing methodologies, understanding of the COVID-19 disease, and specific test performance characteristics. As a sustained leader in laboratory medicine, we will continue to develop and advance our Return-to-Work Protocol to support the return-to-work strategies of our partners.

Sonic Healthcare USA Announces Testing Availability for COVID-19

Sonic Healthcare USA has worked closely with its scientific partners and medical and operational leadership to bring up testing to ensure timely availability for patients in all geographies served by our laboratories. “We are closely monitoring capacity and are coordinating with our clinical laboratories to distribute testing that mitigates high demands from endemic regions and clusters in the United States," said Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA.

Sonic has taken comprehensive measures to expand testing capacity while maintaining high-quality testing and meeting required turnaround times. As a result, Sonic is bringing up multiple testing platforms and methodologies.

Dr. Hussong added, "In response to this public health emergency, Sonic Healthcare USA pledges to do its part and is actively monitoring the situation. Our commitment is to ensure testing is available as this pandemic evolves." The well-being of our patients and employees is our highest priority, and we continue to be committed to the medical communities we serve.

SARS-CoV-2 (COVID-19) Media Statement

Sonic Healthcare USA’s dedicated scientific, medical and operational experts have established SARS-CoV-2/COVID-19 testing in six of our laboratories across the country since March 10, 2020. Our resulting turnaround time is currently within 24-48 hours at all of our affiliated laboratories across the United States. We are closely monitoring immediate demands and actively coordinating with our affiliated clinical laboratories in real time to distribute testing capacity to mitigate high demands from endemic regions and clusters in the United States. We are taking proactive and comprehensive measures to continue to expand testing capacity while maintaining high-quality testing and the turnaround times stated above.

Sonic currently uses multiple platforms and methodologies for SARS-CoV-2/COVID-19 testing and will continue to add capacity as necessary to:

- Maintain critical turnaround time commitments, especially for high acuity patients in the hospitals and for symptomatic healthcare workers.
- Resolve indeterminate results or inconsistencies between test results and clinical presentation.
- Prevent service interruptions due to platform-specific supply chain issues.

We are carefully reviewing our supply chain and communicate daily with our technology and vendor partners to ensure we continue to provide quality and timely service to providers and patients in our communities.

Sonic Healthcare USA Expanding Testing Capabilities by Launching COVID-19 Antibody Testing

Sonic Healthcare USA's network of clinical laboratories has begun performing antibody testing for SARS-CoV-2 (COVID-19) to complement our existing molecular PCR testing.

Sonic Healthcare USA laboratories are initially offering serology testing for SARS-CoV-2 designed to detect IgG and IgA antibodies for patients who are suspected or confirmed of having been exposed to the virus, which causes the coronavirus disease (COVID-19). The tests are being offered for use under the FDA Emergency Use Authorization (EUA).

"Our COVID-19 Medical and Technical Advisory Taskforce has worked hard to develop guidance for our test development and platform strategy to ensure we can support our local medical communities with their testing needs,” said Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA. "It is important to reiterate that results from antibody testing should not be used as the sole basis to diagnose or exclude SARs-CoV-2 infection or to inform infection status or immunity. Follow-up, concurrent or alternative testing with molecular diagnostic testing should be considered for patient management if clinically indicated,” added Dr. Hussong.

Sonic Healthcare USA continues to collaborate with its supply chain vendors to increase testing capacity and platforms to align with projected demand. We are committed to partnering with our local medical communities and public health officials and to be a leader in testing and transitional planning for return to work strategies over the coming weeks to mitigate this pandemic.

Sonic Healthcare USA and other Clinical Laboratory Executives Met with the White House’s Coronavirus Taskforce

This week, Academic and Commercial Reference Laboratory Executives met with Vice President, Mike Pence and members of the White House’s Coronavirus Task Force to collectively discuss diagnostic testing availability for COVID-19.

Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA (Sonic), was among those who met on behalf of the American Clinical Laboratory Association (ACLA) with key government officials, the CDC, and the FDA. At the meeting, key stakeholders discussed the role of state and local public health and commercial laboratories, hospitals, and academic medical centers to increase access to testing for the Coronavirus. “Our main goal, as a commercial laboratory, is to ensure those patients in need or at high-risk can access testing. By working together, we can accelerate those efforts with a coordinated and comprehensive approach,” said Dr. Hussong.

Dr. Hussong added, “Sonic Healthcare is working with its Medical, Scientific and Operational Leadership to make patient testing available through its network of commercial laboratories in the United States and will follow the FDA guidelines for Emergency Use Authorizations (EUAs).” The FDA has recently updated its policy, thus providing an expedited pathway for the availability of diagnostics for COVID-19.

Sonic Healthcare will continue to lead and collaborate with colleagues, government officials, and our local medical communities in response to this immediate public health crisis.

Read the ACLA Statement on COVID-19 Testing.