All posts by aclasuperadmin

ACLA Statement on Senate Republicans’ Coronavirus Relief Package

ACLA News, Featured News

WASHINGTON, D.C. — Following the release of Senate Republicans’ coronavirus relief package, ACLA President Julie Khani issued the following statement:

“ACLA is currently reviewing the Senate Republicans’ coronavirus relief package. At a time when the country is focused on protecting millions of people who are returning to work and school, Americans need a clear federal standard on coverage for testing performed for return-to-work, return-to-school, or public health purposes. Without this guarantee, Americans will continue to face a patchwork system of coverage that undermines our shared goal of safely reopening local economies.

As noted in a letter from nearly 50 leading organizations representing patients, employers and other key stakeholders sent to congressional leaders last week, policymakers must prioritize the creation of a federal fund for this testing. Employees of meatpacking facilities and restaurants, nursing homes, as well as other essential workers, first responders, students and teachers hoping to return to school this fall are critical to our nation’s recovery. These groups need certainty that their tests will be covered.

The federal government’s stake in ensuring reliable coverage for testing is considerable, and Congress should invest the resources to support this critical need. Policymakers must immediately establish a dedicated federal fund to pay for testing not otherwise covered by insurance. As a nation, we can’t afford to have testing be left in limbo.”

 

##

The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.

Data Reporting for COVID-19 Testing

All News

Information and Resources for Providers

Overview
Since the start of the COVID-19 public health emergency, clinical laboratories have worked closely with the provider community and public health officials to ensure relevant patient information is included in COVID-19 test orders.

This critical data helps inform prevention, surveillance and mitigation efforts across the country, including identifying patients at higher risk for infection, hospitalization and death from COVID-19. Further, this information provides important insight to better understand the disproportionate impact of COVID-19 on older Americans, people of color and other marginalized and minoritized communities to ensure that these high-risk populations are protected.

Recent guidance released by the U.S. Department of Health and Human Services (HHS) takes an important step in setting a national standard for data elements and patient demographic information that must be collected and reported for COVID-19 testing. Clinical laboratories rely on physicians, nurse practitioners, pharmacists, physician assistants and other health care providers to include demographic information from patients on every test order. Clinical labs do not typically interact directly with patients, making their ability to collect patient information limited to the data they receive from the ordering provider.

If we are to make progress on addressing the disproportionate impact of COVID-19 on marginalized and minoritized communities, we must work collaboratively to address gaps in our data reporting system. First and foremost, providers and laboratories must be committed to adhering to their respective reporting requirements and work together to close any data gaps in the least burdensome way possible. Furthermore, it is critical that we modernize our country’s health IT systems to provide clinicians and laboratories with the tools and information they need to accurately and efficiently capture data on testing orders, not just for COVID-19, but for public health surveillance broadly.

Addressing the current patchwork reporting system across the states as well as the ongoing technical challenges will require strong federal coordination and leadership, and clinical labs are committed to supporting these important reporting efforts as part of our robust response to the COVID-19 pandemic.

Below are Frequently Asked Questions regarding COVID-19 data reporting. For additional questions, please reach out to Liz Thomas (lthomas@acla.com).

Frequently Asked Questions

  1. Why has HHS expanded the kinds of information that must be reported by laboratories and other entities that conduct COVID-19 testing?
    HHS developed this guidance in response to the recently enacted CARES Act, which requires that “every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19” reports the results from each such test in a manner determined by HHS. Although state and local public health departments have required testing results reporting since the beginning of the COVID-19 public health emergency, the requirements for patient information and other data elements have varied across states. The recent HHS guidance creates a national standard for the data fields required so that this critical information can inform real-time clinical interventions and mitigation strategies across the U.S.
  2. What information must be collected and reported for COVID-19 testing?
    Beginning August 1, 2020, HHS will require that laboratories and other entities that conduct COVID-19 testing immediately begin reporting the following information:

    1. Test ordered
      1. Use harmonized LOINC codes provided by CDC.
    2. Device Identifier
    3. Test result
      1. Use appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.
    4. Test Result date (date format)
    5. Accession #/Specimen ID
    6. Patient age or DOB
    7. Patient race
    8. Patient ethnicity
    9. Patient sex
    10. Patient Street address
    11. Patient residence zip code
    12. Patient residence county
    13. Ordering provider name and NPI (as applicable)
    14. Ordering provider zip
    15. Ordering Provider phone number
      1. This is a critical element to assist public health authorities in follow up.
    16. Performing facility name and/or CLIA number, if known
    17. Performing facility zip code
    18. Specimen Source
      1. Use appropriate LOINC, SNOMED-CT, or SPM4 codes, or equivalently detailed alternative codes.
    19. Date test ordered (date format)
    20. Date specimen collected (date format)
    21. First test (Y/N/U)
      1. Indicates whether this is the patient’s first test for the condition of interest.
    22. Employed in healthcare? (Y/N/U)
      1. Indicates whether patient is employed in a healthcare setting, particularly those who work in a high-risk setting with patients.
    23. Symptomatic? (Y/N/U)
      1. This is defined per current CDC guidance at time of order for the reportable condition/illness.
      2. If yes, then Date of Symptom Onset (mm/dd/yyyy).
    24. Hospitalized? (Y/N/U)
      1. Indicates whether the patient has been hospitalized for the reportable illness/condition that this order has been placed for (suspected or diagnosed).
    25. ICU? (Y/N/U)
      1. Indicates if patient has been admitted/transferred to the ICU at any time during the encounter for the reportable illness/condition that the order has been placed for (suspected or diagnosed).
    26. Resident in a congregate care setting? (Y/N/U)
      1. This includes nursing homes, residential care for people with intellectual and developmental disabilities, psychiatric treatment facilities, group homes, board and care homes, homeless shelter, foster care or other setting at time of exposure where they normally live.
    27. Pregnant?
      1. If the patient is female, expected answers are: Patient currently pregnant or possibly pregnant (Y); Not pregnant (N); or Unknown (U).
  3. For which kinds of tests is public health reporting required?
    Federal guidance and state laws require public health reporting of patient information for all COVID-19 tests conducted at a lab or other entity with a certificate under the Clinical Laboratory Improvement Amendments (CLIA). Reporting is required for all diagnostic tests to detect infection with SARS-CoV-2 and antibody tests to detect immune response, regardless of the outcome of the test. It is critical that clinicians collect patient demographic information when ordering a COVID-19 test and include that information when the specimen and test order are sent to a lab. Laboratories are then required to report the patient data they receive from the clinician for each individual tested for COVID-19 within 24 hours of receiving results. In the case of point-of-care (POC) testing, clinicians performing POC tests are also required to report required patient data with all test results to public health departments beginning August 1. Reporting must happen on a daily basis to the appropriate state or local public health department based on where the individual resides or where the provider is located if the patient is out-of-state.
  4. Who is obligated to participate in public health reporting for COVID-19 test results, and how should patient information be collected?
    Laboratories and other entities with CLIA certificates that conduct COVID-19 testing are required to report test results and patient information to local or state public health departments. Clinicians that order COVID-19 tests are required to collect all required patient information (noted in Question 2 and listed here) when ordering the test. Clinicians must share this information with laboratories when submitting the test order, or in the case of POC testing, clinicians conducting POC tests must report results with patient information, including the expanded data elements to the local and/or state public health department directly.Federal guidance specifies that entities conducting testing should utilize one of the following methods of submission:

    • Submission of laboratory testing data directly to state or local public health departments, as required by state and/or local law or policy, followed by submission of de-identified data to the CDC, as the HHS designee, on a daily basis using either Health Level 7 (HL7) messaging or the CDC-provided CSV format.
    • Submission of laboratory testing data to state and local public health departments through a centralized platform (such as the Association of Public Health Laboratories’ AIMS platform) where such data will then be routed to the appropriate state and local authorities and routed to CDC after removal of elements to achieve de-identification according to applicable rules and regulations.
    • Submission of laboratory testing data through a state or regional Health Information Exchange (HIE) to the appropriate state or local public health department or to CDC as directed by the state.
  5. To which state public health departments should clinicians and labs report patient information and test results, and where can providers find more information about reporting requirements?
    The reporting obligation is based on the patient’s residence or the provider location for cases when a patient is out-of-state. Clinicians and labs should contact their local and/or state departments of health directly for more information on reporting requirements and the method for reporting.
  6. What happens if the provider who is caring for the patient being tested does not provide the required patient information – how can the laboratory secure the necessary information?
    Ordering providers should make every effort to collect this critical information from patients during ordering and/or the specimen collection process. If ordering providers do not collect this information from patients, labs lose the opportunity to provide robust data to public health authorities to inform COVID-19 response efforts.

To download a sharable copy of these FAQs, click here.

Patients, Employers, Labs and Health Insurance Providers Call on Congress to Dedicate Funding for COVID-19 Testing to Get America Back to Work and School

ACLA News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – The National Consumers League, the American Clinical Laboratory Association (ACLA) and America’s Health Insurance Plans (AHIP) joined nearly 50 leading stakeholders representing patients, employers, clinical laboratories, health insurance providers and other leaders from across health care community yesterday in sending a letter to congressional leadership requesting dedicated federal funding for the critical testing needed to reopen the country.

“Every American, especially essential workers, clinicians and physicians on the front lines of health care, should have access to the COVID-19 tests they need,” said NCL Executive Director Sally Greenberg. “To reduce transmission of the virus, improve public health, increase surveillance capacity and help Americans return to work, school and other activities, Congress must provide robust dedicated funding for testing.”

“Testing is one of the most important tools we have to combat this crisis, both for identifying the virus and also for preventing its spread in communities across the country,” said ACLA President Julie Khani. “It’s vital that the federal government designate the resources to support expanded access to testing.”

The letter was signed by a 49 organizations from across health care community, including 1in9 L.I. Breast Cancer Organization/Hewlett House, Academy of Managed Care Pharmacy, ACLA, ADAP Advocacy Association, AdvaMedDx, AHIP, AMDA-The Society for Post-Acute and Long-Term Care Medicine, American Association for Respiratory Care, American Association of Neurological Surgeons, American Association of Nurse Practitioners, American College of Physicians, American Geriatrics Society, American Health Care Association, American Society for Microbiology, America’s Physician Groups, APS Foundation of America, Inc, Arizona Bioindustry Association, Inc. (AZBio), BioKansas, Black Women’s Health Imperative, Blue Cross Blue Shield Association, Business Group on Health, Business Roundtable, California Hepatitis C Task Force, California Life Sciences Association (CLSA), Community Access National Network (CANN), Congress of Neurological Surgeons, Cutaneous Lymphoma Foundation, Healthcare Leadership Council, ICAN, International Cancer Advocacy Network, Infectious Disease Society for America (IDSA), International Association of Hepatitis Task Forces, International Pemphigus Pemphigoid Foundation, Johns Hopkins Center for Health Security, LeadingAge, Lupus and Allied Diseases Association, Inc., March of Dimes, Michigan Biosciences Industry Association (MichBio), National Association of Area Agencies on Aging (n4a), National Association of Manufacturers, National Consumers League, National Health Council, National Hispanic Medical Association, National Retail Federation, New Jersey Rheumatology Association, Oncology Managers of Florida, the Gerontological Society of America, the Society for Healthcare Epidemiology of America, U.S. Chamber of Commerce and the Virginia Public Health Association.

Highlights of the letter are included below. To read the full letter, click here.

  • “Swift action is needed to ensure that every American, especially essential workers, frontline healthcare physicians and other clinicians and those at disproportionate risk for COVID-19 have access to vital COVID-19 testing, whether for diagnostic, occupational, return-to-school, public health or virus monitoring purposes.”
  • “Expanded access to COVID-19 testing for all individuals, regardless of their coverage status or purpose for receiving the test (i.e. diagnostic, public health or return-to-office), will require additional dedicated and robust federal funding. Without such funding, and with demand increasing, Americans will only see a reduction in access to testing, as well disruptions in clinician, hospital, and laboratory payments, diminished public health surveillance capacity, and higher insurance premiums – all while millions of Americans begin to seek testing in exponential numbers to facilitate return to work, school and other normal activities.
  • “We share the goal of safely reopening the economy and returning to normal business, but this will require a sustained federal investment in testing facilitated by the public health and existing health care delivery system. Such a commitment will serve to support reopening and help to prevent and mitigate the spread of COVID-19. Dedicated federal funding, and clear coverage guidelines are critical for the scale and degree of testing that is needed to reopen, to reduce the risk of transmission, and to understand the progression of the disease and aid in development of better treatments and vaccines.”

 

###

About the National Consumers League (NCL)

The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.

About the American Clinical Laboratory Association (ACLA)

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

 

Behind the Scenes Responding to COVID-19

ACLA Blog, Public Health Preparedness and Infrastructure

Across the country, clinical laboratory professionals are hard at work developing innovative testing methods and performing complex diagnostic tests for COVID-19. Chris Burns, an instrument specialist at ARUP, is one of the many lab professionals helping to process ARUP’s COVID-19 molecular diagnostic test for patients each day.

In his role at ARUP’s lab in Utah, Chris has been a vital member of the team, first helping to get ARUP’s COVID-19 PCR test up and running and then continuing to monitor and adjust the lab’s high-complexity testing tools throughout the pandemic.

Chris and his team perform tests that are highly involved, requiring collaboration from a host of experienced technologists to deliver accurate results to patients and providers. While doctors rely on testing results every day to guide medical decisions and inform treatment plans, “most patients don’t see what goes on in a clinical lab or a big reference lab like this. Most of the time the patient just gets their blood drawn or gets their nose swabbed,” said Chris. But that’s just where the work begins for these lab professionals.

Chris is acutely aware about the impact his work has on patient health. “Everyone who’s a clinician knows that there’s a person behind each sample that comes in, or each test that’s ordered. And especially with this COVID-19 crisis, that’s been more apparent,” said Chris. With this understanding, lab professionals are committed to ensuring patients and providers receive the critical results they need. “We always strive and try our best to try and get these results out as soon as possible,” shared Chris.

When it comes to healthcare, and especially a public health crisis like the COVID-19 pandemic, doctors and experts rely heavily on clinical testing to provide critical diagnoses and surveillance. “It feels good as a clinician to say that ‘We’re here for you. We are working our best. We’re trying our hardest to make sure that you experience that fear as little as possible,’” said Chris.

Watch highlights from the interview with ARUP’s Chris Burns.

ACLA Update on PCR Testing Capacity for COVID-19

All News, Featured News, ACLA Press Releases

WASHINGTON, D.C. – As ACLA member laboratories continue to navigate unprecedented demand and significant supply challenges, ACLA President Julie Khani issued the following statement:

“In light of the ongoing spread of COVID-19 in states across the country, many labs are now receiving more test orders than they are able to process in a single day. We have urged ordering providers to prioritize testing for those most in need, especially hospitalized and symptomatic patients. That will help better manage demand for testing while labs continue to perform COVID-19 testing and increase their capacity, which will require adequate supplies and additional equipment.

Since the federal government first cleared regulatory hurdles to expand testing on February 29, ACLA member laboratories have performed over 20 million molecular tests for COVID-19.  We have made significant strides in expanding capacity, which has tripled since early April, and ACLA labs are now performing more than 300,000 tests each day. Our members have been committed from the earliest stages of this pandemic to do everything possible to increase access to testing and have pioneered a wide range of innovative approaches to meet testing demand. From developing and bringing to market new tests to diagnose this evolving virus, to engaging physicians and public health partners around the importance of ordering guidelines and data that must be collected at the point of care, to closely monitoring supplies with diagnostic manufacturers and the federal government, ACLA members have responded with actionable solutions to facilitate patient access to testing.

But we can’t do it alone.  Laboratories, diagnostic manufacturers, ordering providers, public health officials, states and importantly, the federal government – including Congress and the Administration – all have a role to play in addressing the challenges hampering our nation’s response to this public health crisis.

In collaboration with the broader diagnostics community, we are exploring new technologies and testing strategies to maximize capacity for COVID-19 molecular testing, including targeting the use of antibody testing, expanding antigen and other point-of-care testing, and implementing specimen pooling in low-prevalence areas and populations.  ACLA laboratories will continue to bring forward novel approaches to expand testing capacity and work closely with regulatory agencies to maximize their use.

Accurate and reliable testing is one of the most important tools we have to combat this crisis, but what we do with the information yielded by these tests is just as important. Testing is a critical component of a comprehensive and coordinated public health strategy within each community, which also must include other elements such as adherence to mask protocols and social distancing recommendations.

As we work to mitigate the spread of the virus and meet the range of needs facing the country, including the reopening of schools and workplaces, now is the time for the federal government to outline a clear action plan to guide us through this pandemic.  ACLA members will continue to do our part in expanding COVID-19 testing capacity to support the public health needs our nation faces now and in the future.”

ACLA Update on COVID-19 Testing Capacity

Featured News, ACLA Press Releases

WASHINGTON, D.C – Following a surge of new COVID-19 cases in the United States, ACLA President Julie Khani issued the following statement:

“ACLA member laboratories have seen a steady increase in the volume of COVID-19 test orders. While our members are collectively performing hundreds of thousands of tests each day, the anticipated demand for COVID-19 testing over the coming weeks will likely exceed members’ testing capacities. This significant increase in demand could extend turnaround times for test results.

Collectively, ACLA members have made significant strides to expand testing capacity, performing about 100,000 tests per day in early April to more than 300,000 tests per day currently. All across the country, clinical laboratories are increasing the number of labs processing tests, purchasing additional testing platforms and expanding the number of suppliers to provide critical testing materials. However, the reality of this ongoing global pandemic is that testing supplies are limited. Every country across the globe is in need of essential testing supplies, like pipettes and reagents, and that demand is likely to increase in the coming months. We are in active conversations with the Administration and supply partners about ways to address these challenges.

We encourage communities to heed the advice of public health officials, such as practicing safe social distancing and wearing masks in public. We know there’s more work to be done at this critical time, and ACLA member laboratories will continue to rise to the challenge.”

 

#

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.