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CAP Responds to Your COVID-19 Questions

Please note this page is iterative and we are adding more questions as we receive and answer them. Also, see COVID-19 Laboratory Reporting FAQs and Implementing a SARS-CoV-2 Test in Your Laboratory. If you have a question, please email us at accred@cap.org.

Availability of Testing

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Laboratories subject to US regulations may use the following types of tests as described in the US Food and Drug Administration (FDA) Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency:

  • Tests authorized through the FDA Emergency Use Authorization (EUA) process 
  • Laboratory-developed test (LDTs) 
  • Tests authorized by the state where the laboratory is located.

As of August 19, 2020, laboratories may develop and validate their own tests for COVID-19 without submission of an EUA. The US Department of Health and Human Services (HHS) published a notice indicating that premarket review by the FDA will not be required for laboratory-developed tests (LDTs) for COVID-19. The FDA is currently not reviewing applications for EUA for LDTs. If a laboratory decides to use an LDT, the following important conditions apply:

  • The test is not eligible for PREP (Public Readiness and Emergency Preparedness) Act coverage, which provides immunity from liability for testing developed as a countermeasure for the COVID-19 pandemic.
  • The test is subject to the CAP requirements and CLIA regulations for the following:
    • Establishing and validating test performance specifications for LDTs prior to beginning patient testing (42CFR493.1253)
    • Holding the appropriate CLIA certificate type (Certificate of Accreditation, Certificate of Compliance, or Certificate of Registration)
    • Performing tests by personnel qualified to meet high complexity testing requirements.

Reference CAP accreditation checklist requirements: COM.40350, COM.40475, COM.40500, COM.40830, COM.40840, COM.40850, GEN.20361, GEN.54750

View a current list of tests with EUA authorization

Laboratories not subject to US regulations may use the following types of tests, if allowed by country and regional regulations and guidelines:

  • Tests authorized through the FDA Emergency Use Authorization (EUA) process
  • Tests listed on the World Health Organization Emergency Use Listing (EUL)
  • Tests approved by internationally recognized regulatory authorities (eg, CE-marking)
  • Laboratory-developed tests that have been validated by the laboratory at which the test will be performed

View a current list of tests with EUA authorization 

View a current list of tests with EUL authorization

Your laboratory can use serology tests obtained from a commercial manufacturer or develop its own test. The number of serology tests with emergency use authorization (EUA) has been steadily growing. The FDA website includes a listing of all EUA tests for COVID-19 and includes information on the type of laboratory setting authorized to perform the testing. Section D of the FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency contains helpful guidance on development and use of serology tests for commercial manufacturers and laboratories.

Laboratories using an EUA test must:

  • Verify the test method performance specifications prior to beginning patient testing, as applicable and have the laboratory director or designee meeting CAP director qualifications approve the test for use (see the Q & A section on Test Method Validation/Verification)
  • Follow manufacturer’s instructions as written
  • Hold the appropriate type of CLIA certificate based on the complexity of the testing
  • Perform testing using personnel qualified to meet qualifications based on the complexity of the testing.

The FDA requires all commercial manufacturers that distribute serology tests for COVID-19 to prepare and submit for EUA within a reasonable period of time (ie, 10 business days). If laboratories perform patient testing using these commercial tests prior to FDA authorization of the EUA, the testing may only be performed by laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high complexity testing. High complexity testing requirements apply.

The FDA also includes a listing of tests that may no longer be distributed for COVID-19 testing in its FAQs on Diagnostic Testing for SARS-CoV-2. This includes tests where an EUA was not submitted to the FDA within a reasonable period of time or where there were significant problems identified that cannot or have not been addressed in a timely manner.

Laboratories that develop their own serological tests (LDTs with no EUA) must:

  • Establish and validate the test method performance specifications of LDTs prior to beginning patient testing.
  • Hold the appropriate CLIA certificate type (Certificate of Accreditation, Certificate of Compliance, or Certificate of Registration)
  • Perform testing using personnel qualified to meet high complexity testing requirements.

Section D of the FDA Policy contains recommendations for validation, including validation of cross-reactivity/analytical specificity, class specificity, and clinical agreement studies. The FDA also has a Serology Template for Laboratories to assist laboratories in developing their own tests.

The FDA also offers another option under Section B of the FDA Policy to give states the authority to approve COVID-19 tests without FDA review for use within their state. A listing of states that have requested this authority is located on the FDA’s FAQs on Diagnostic Testing for SARS-CoV-2. Tests authorized by a state are considered equivalent to tests with FDA EUA authorization. Laboratories introducing these tests must follow requirements listed above for EUA tests. State authorization of a test is limited to use in that specific state. Laboratories seeking to use a test authorized in a different state are subject to Section D of the FDA Policy.

Reference CAP accreditation checklist requirements: COM.30980, COM.40300, COM.40350, COM.40475, COM.40500, COM.40640, COM.40850, GEN.54750, GEN.20361.

Although many COVID-19 serology test kits have been marketed for point-of-care use over the last few months, the FDA only recently authorized the first test for use in a patient care setting. The FDA deems tests authorized for use in a patient care setting as waived, even if testing is performed in the main laboratory under a CLIA certificate of accreditation or registration. The CAP recommends that laboratories continue to check the FDA’s current list of tests with EUA authorization when evaluating a test for possible use at your facility.

There are various tests that have been approved for patient self-collection in the home setting. The FDA evaluates product claims for unsupervised home collections as part of the EUA process. The CAP recommends that laboratories refer to the FDA and CDC website information for guidance on the COVID-19 self-collection kits.

For more information:

FDA’s Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing – Letter to Health Care Providers

CDC instructions – How to Collect your Anterior Nasal Swab Sample for COVID-19 Testing

List of home collection tests for COVID-19

Current template

Accreditation Questions

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Update your laboratory’s activity menu in Organization Profile by logging into e-LAB Solutions Suite on cap.org.

The following activities are being used to identify COVID-19 assays:

Molecular-based assays:

  • nCOV 2019, NAA, EUA, nonwaived*
  • nCOV 2019, NAA, EUA, LDT*
  • nCOV 2019, NAA, EUA, waived
  • nCOV 2019, NAA, EUA, waived, POCT

* If testing is performed by next generation sequencing (NGS), add the appropriate activity(s) above and the specific NGS activities from the list below that apply to the portion of the NGS testing performed at your laboratory. Laboratories using NGS for COVID-19 testing are inspected with both the Molecular Pathology and Microbiology Checklists.

  • NGS, analytical wet bench, Molecular Pathology
  • NGS, bioinformatics, Molecular Pathology
  • NGS, interpretation, Molecular Pathology
  • NGS, microbiology

Antigen assays:

  • SARS (CoV) antigen, EUA, waived
  • SARS (CoV) antigen, EUA, waived, POC

Serology assays:

  • nCOV 2019 antibodies
  • nCOV 2019 antibodies, flow cytometry
  • nCOV 2019 antibodies, rapid test, POCT

Important information:

  • The waived activities may only be used for assays that have received authorization by the FDA for use in the patient care setting. Assays that have only received authorization for CLIA-certified moderate and high complexity laboratories must use the non-waived activity, even if the test is performed in a patient care setting.
  • If you are unsure how your laboratory’s test was authorized, review the EUA Letter of Authorization for your specific test on the FDA website.
  • You will not be able to add the nonwaived molecular-based EUA activity to an existing point-of-care section. Instead, create a new section unit and add the appropriate nonwaived activity.
  • If you do not see the activities listed in Organization Profile, you can add them as a write-in activity.

If you need assistance, contact the CAP at accred@cap.org or 800-323-4040.

Reference CAP accreditation checklist requirement: COM.01200.

No, an asymptomatic individual may be suspected of COVID-19 for various reasons, such as known exposure or working in a high-risk environment. Individuals suspected of COVID-19 infection may be symptomatic, pre-symptomatic, or asymptomatic. The decision to order a test for an individual suspected of COVID-19 is at the discretion of the health care provider or individual authorized to order a test.

For testing of asymptomatic individuals not suspected of having COVID-19, the use of a diagnostic COVID-19 test may be off-label or outside of the instructions for use. The FDA has provided recommendations to use a highly sensitive test for this purpose or to use other approaches, such as a less sensitive point-of-care test with serial testing.

Laboratories should educate health care providers on the types of testing available. Results of testing must be considered in the context of the individual’s clinical and other information.

The FDA’s EUA templates contain validation recommendations for use of tests to screen asymptomatic individuals.

For more information on use of tests for screening asymptomatic patients, please see the following resources:

Reference CAP accreditation checklist requirement: GEN.40930

Antigen tests can be used for any of these testing strategies.

Diagnostic testing is to identify individuals with current infection with COVID-19 symptoms or asymptomatic individuals who have had recent known or suspected exposure to COVID-19.

Screening testing is intended to identify infected individuals who are asymptomatic or are without known exposure to COVID-19 and include congregate settings with high risk of exposure. Examples of such situations may include long-term care facilities, correctional facilities, workplace or school testing of students, faculty and staff.

Surveillance testing is used to monitor for community or population-level infections, noting the incidence and prevalence of the disease. Surveillance testing is not linked to an individual but rather an aggregate group. Individual results are not provided.

The laboratory should evaluate the clinical performance of the test kit, recognizing that antigen tests are generally less sensitive than the “gold standard” molecular PCR tests. Confirmatory testing may be required if the clinical picture is inconsistent with the antigen results. The antigen tests provide high specificity, are relatively easy to use, have rapid turnaround time, and can be used in the point-of-care setting.

For more information, refer to the CDC Interim Guidance for Rapid Antigen Testing for SARS-CoV-2 Using Antigen Tests.

Surveillance testing is usually a public health activity used for monitoring the occurrence of an infectious disease outbreak in a population or community, or to characterize the occurrence once detected (eg, looking at the incidence and prevalence of the occurrence). The testing is intended to be performed to gain information at a population level, rather than an individual level. The need to obtain a CLIA certificate and report the testing to the CAP may vary based on how the testing is performed.

  • Laboratories that do not report patient-specific results may qualify to be exempted from CLIA certification.
  • In most cases where patient-specific results are reported from the laboratory, and those results will be or could be used “for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings”, the testing is subject to CLIA (absent evidence to the contrary).

Laboratories are not required to include testing not subject to CLIA on their activity menus (eg, research and surveillance testing where patient-specific results are not reported) but may opt to include such testing if the laboratory wants it to be inspected by the CAP.

For more information, the following guidance documents are available from the CMS:

Reference CAP accreditation checklist requirements: GEN.20361, COM.01200

Testing to return to work is considered an assessment of health and, as such, CLIA applies. In addition, if the test results are being used for purpose of referring, offering, or making treatment available, CLIA also applies. The CAP requires all testing performed under a laboratory’s CLIA certificate to be include on the laboratory’s CAP activity menu for inspection.

Employee testing is not subject to CLIA when it is used for hiring, firing, or disciplinary action. Laboratories may opt to report such testing to the CAP if the laboratory wants it to be inspected by the CAP.

Reference CAP accreditation checklist requirements: GEN.20361, COM.01200

COVID-19 testing has not been assigned a CMS specialty or subspecialty yet. The CMS has stated that it will inform laboratories once it has been assigned.

In the interim, laboratories may perform testing based on the intended use of the test for which it has been authorized. For example, tests that have been authorized for moderate or high complexity testing laboratories can be performed in laboratories with CLIA certificates of accreditation, compliance, or registration. Tests authorized for patient care settings may be performed by laboratories with the CLIA certificate types listed above and by laboratories with CLIA certificates of waiver.

CLIA-certified laboratories may open temporary testing sites and perform the testing under their own site’s CLIA certificate under conditions defined by the CMS Surveys & Certification Memorandum S &C 12-09-CLIA. The temporary site must use the address of the primary laboratory and all testing performed in the temporary testing site must fall within the scope of the primary site’s certificate. The temporary site must follow the checklist requirements for the testing performed at that location. All reports would be issued under the primary laboratory name, address and CLIA number.

If your laboratory decides to add a temporary testing site under your laboratory’s CLIA certificate

  • Notify your state CLIA agency to obtain approval
    • Confirm that your laboratory’s situation qualifies for the exception
    • Ask the state to update the CLIA record to indicate the applicable exception and the location of each test site
  • Update your laboratory’s CAP test menu to include the alternative test site information. Please contact the CAP at 800-323-4040. A CAP Operations Specialist can help advise you on the best way to add the related sites and set this up in Organization Profile based on your specific scenario.

For existing testing in laboratory sections involving temporary remote review of slides, data, and images by pathologists and other laboratory professionals, it is not necessary to list these temporary test sites (eg, home location) in Organization Profile.

The CAP understands that laboratories may need to make temporary adjustments to day-to-day operations to manage staffing shortages, workload, and address the demands of COVID-19 testing. Whether your laboratory is considering discontinuing some patient testing to divert resources to COVID-19 testing or planning to temporarily cease all patient testing activities, there are a few steps you need to take to maintain your institution’s CAP accreditation status and maintain compliance with proficiency testing (PT) requirements.

  • If you are temporarily closing and ceasing all patient testing, send an email to accred@cap.org with your intent. The CAP will change your laboratory’s accreditation status to accredited with a requirement for an update to the CAP in three months.
  • If you are temporarily discontinuing a portion of your testing (eg, for a period of three months), do not take any action to remove the tests from your activity menu. Refer to the FAQ below for actions needed to manage proficiency testing.
  • If you are discontinuing testing permanently, log into cap.org and remove the tests in Organization Profile. Refer to the FAQ below for actions needed to manage proficiency testing. 

When the laboratory is ready to resume testing, it must follow the steps described in COM.40805 to verify readiness for testing. If your laboratory previously removed activities from its activity menu, log into cap.org and update your activity menu in Organization Profile.

Reference CAP accreditation checklist requirements: COM.01200, COM.40805

We recommend that you do not cancel your PT order for programs associated with temporarily discontinued testing. Instead, postpone testing these kits until your laboratory resumes patient testing. Laboratories are required to perform PT (or alternative assessment if PT is not available) once patient testing resumes.

Here are steps to take if your laboratory is temporarily discontinuing some laboratory testing (eg, for three months).

  • Assign a member of your laboratory staff to manage CAP notifications related to proficiency testing (PT) for the discontinued laboratory tests. Consider changing your business email to your personal email in My Profile to manage notifications.
  • Visit My PT Shipping Calendar in e-LAB Solutions Suite.
    • Review shipping dates for PT kits for temporarily discontinued laboratory testing.
    • Identify due dates for resulting these PT kits
  • Receive and store PT kits related to temporarily discontinued laboratory testing. Follow kit instructions for proper storage conditions.
  • Prior to the due date, go to PT Result Data Entry in e-LAB Solutions Suite to access the appropriate result form.
    • Leave the result area blank
    • Fill the Exception Code 11 bubble on the results form for all temporarily discontinued testing. This is defined as: ‘Unable to analyze’ for analytes your laboratory is not performing.
  • Once your laboratory resumes patient testing, you have two options to meet PT requirements.
    • Test your stored PT kit and perform/record a self-evaluation using the participant summary report. Any PT results falling outside the criteria for acceptable performance must be investigated and have corrective action taken, as would be done for graded PT results. These records must be retained for your next onsite inspection.
    • If PT is not available, perform alternative performance assessment (COM.01500).

Contact a Customer Contact Center representative at 800-323-4040, +001-847-832-7000 option 1, or email contactcenter@cap.org if you have questions.

Reference CAP accreditation checklist requirements: COM.40805, COM.01300, COM.01500.

Laboratory retention policies must be based on specimen stability and the potential need for repeat or confirmatory testing. In addition, policies must comply with national, federal, state (or provincial), and local laws and regulations.

The Laboratory General Checklist requirement GEN.20377 includes general retention periods that apply to serologic testing using serum and plasma. Serum and plasma must be retained for a minimum of 48 hours (with exceptions made at the discretion of the laboratory director). No specific minimum retention periods are defined for whole blood specimens, or for swabs and transport media used for viral molecular-based testing. The laboratory director must determine the appropriate retention time for specimen types not defined in the checklist.

Suggested considerations for defining retention policies include:

  • Specimen collection and handling information and defined stability period in the manufacturer’s instructions for use
  • Specimen type (eg. dry swabs, specimens collected in transport media, extracted genomic material)
  • Specimen storage conditions
  • Retention of specimens for troubleshooting purposes or further testing (eg. in the event of manufacturer recalls, proficiency testing failures, or physician complaints).

Reference CAP accreditation checklist requirements: GEN.20377, MIC.63328

The CAP has received various questions relating to different types of equipment, such as chemistry analyzers, pipettes, and hoods, where service vendors have notified the laboratory that they are not able to come to the laboratory to perform service at this time. The CAP recognizes that some things will be more critical than others based on the type of equipment. It is essential for laboratories to document what has occurred, make reasonable efforts to meet the requirement with consideration of the pandemic, and address outstanding items when circumstances allow.

In these situations, the CAP recommends you take the following actions:

  • Create a record to document and track the issue
  • Determine if there are reasonable alternatives to complete the maintenance or perform an assessment of the affected equipment to determine if the laboratory can continue to use it
  • Monitor performance of the equipment through routine QC and/or function checks, as applicable.
  • Continue to work with vendors to complete the necessary maintenance as needed and record actions taken.
  • Retain records of the issue and its resolution for at least two years.

Having these records will benefit laboratory staff in troubleshooting problems that may occur with the equipment and for tracking items that still need to be completed. We also recommend having these records available for your next CAP inspection to help explain any gaps or delays.

Reference CAP accreditation checklist requirements: COM.30600, COM.30675

In early June 2020, the CAP sent an eAlert announcing its plans to resume routine CAP inspections of US laboratories. In late August, another eAlert was sent announcing a modified inspection process to best address the current climate in health care and increase safety measures.

The CAP continues to postpone most scheduled and requested international inspections at this time. Some inspections using regional inspection teams may start to occur in areas where this is practical and possible. The CAP does not endorse performing inspections in areas where significant COVID-19 spread is occurring, and urges laboratory directors and inspection team leaders to share current information on local COVID-19 infection rates with each other, including any changes that may occur as a planned inspection date arrives. Inspectors are instructed to delay any inspections if either the laboratory’s area or the inspector’s area currently has significant community spread occurring and/or high COVID-19 positivity rates.

The CAP will continue to update inspection information as things change on its COVID-19 Information page.

Test Method Validation/Verification

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Laboratories using an unmodified EUA test must verify the test method performance specifications as applicable to the test’s FDA designated authorized setting. All tests must be approved for use by the laboratory director or designee meeting CAP director qualifications prior to beginning patient testing.

For tests authorized for use in a patient care setting, the laboratory must follow manufacturer’s instructions for waived test implementation (COM.30980) at minimum. The FDA deems these tests to be CLIA waived, even if testing is performed in the main laboratory under a CLIA certificate of accreditation or registration.

For tests authorized for use in moderate or high complexity testing laboratories only, the test method verification must include analytical accuracy, precision, reportable range, and reference intervals. They are subject to All Common Checklist requirements for test method verification of nonwaived testing.

Laboratories may use information published in the manufacturer’s package insert and other published literature for some aspects of the verification study. For example, the manufacturer or Centers for Disease Control may be able to provide a list of interfering substances (COM.40500). While the ultimate objective is to fully verify the method performance of the assay, the pandemic crisis, urgent need for patient testing, and possible lack of reagents and supplies make it difficult to fully evaluate the accuracy, precision, and reportable range, as stated in COM.40300. A more limited approach may be acceptable. You and your laboratory director should determine the depth of verification needed to begin testing.

The test kits may have quality control materials for checking performance of the test kit. For accuracy verification, laboratories may use known positive and negative patient specimens, positive and negative QC materials, and other commercially purchased materials. The use of contrived (spiked) patient specimens is no longer recommended for test method verification due to the increased availability of positive natural clinical patient specimens. The CAP encourages laboratories to continue to evaluate assay performance with actual patient specimens.

Download a CAP example template for analytical verification by logging into e-LAB Solutions Suite and searching for “analytical verification”.

Reference CAP accreditation checklist requirements: COM. 30980, COM.40300, COM.40475, and COM.40500

A new panel is a separately manufactured device and is considered a new test. The laboratory must verify the test method performance specifications as applicable to the test’s FDA designated authorized setting and have it approved for use by the laboratory director or designee meeting CAP director qualifications prior to beginning patient testing.

For tests authorized for use in a patient care setting, the laboratory must follow manufacturer’s instructions for waived test implementation (COM.30980) at minimum. The FDA deems these tests to be CLIA waived, even if testing is performed in the main laboratory under a CLIA certificate of accreditation or registration.

For tests authorized for use in moderate or high complexity testing laboratories only, the laboratory must verify the performance of the new analyte(s) being added and determine the extent of the verification needed for the previously verified analytes on the panel to ensure that they were not affected by the change.

If your laboratory previously implemented an individualized quality control plan (IQCP) for a nonwaived panel, the laboratory needs to determine if there are any additional risks that were not considered and update the existing risk assessment and quality control plan if appropriate.

Reference CAP accreditation checklist requirements: COM.30980, COM.40300, COM.40475, and MIC.65220

During the COVID-19 health care emergency, commercial manufacturers that have validated a test and plan to submit for EUA are allowed to distribute the test for use by laboratories following the FDA policy under Section C. Laboratories may begin performing patient testing after they complete a verification study. While the ultimate objective is to fully verify the test method performance, the pandemic crisis and urgent need for patient testing have prompted the FDA to allow additional pathways to get the needed testing quickly and safely into use. Laboratories may follow a more limited approach when introducing these tests. You and your laboratory director should determine the depth of the verification needed to begin testing and your laboratory director (or designee meeting CAP director qualifications) must approve the verification study prior to testing. The CAP recommends performing a study using a minimum of 20 negative and 20 positive COVID-19 specimens to verify test performance if used for patient testing prior to the release of the EUA.

The manufacturers must make the status of such testing transparent to any purchasers or users. In addition, the FDA recommends the use of a general statement on the test report that the test has been validated, but that the FDA’s independent review of the validation is still pending. Following Section C of the FDA policy, the manufacturers must continue to follow the timelines defined in the FDA policy for submission for final EUA and notify users of any problems encountered.

Reference CAP accreditation checklist requirements: COM.40300, COM.40475, and COM.40500

No, an EUA assay is not considered an LDT. Laboratories using EUA assays should follow CAP checklist requirements for FDA-cleared/approved tests.

The requirements for test method verification described above for EUA assays in laboratories subject to US regulations also apply to EUA assays performed in international laboratories and to the following types of assays, if performed following the manufacturer’s instructions:

  • Tests listed on the WHO EUL.
  • Tests approved by an internationally recognized regulatory authority (eg, CE-Marking).

Laboratories that develop their own assays or obtain test kits through unapproved or unauthorized sources are required to perform a complete validation (refer to the item on laboratory-developed tests below).

Reference CAP accreditation checklist requirements: COM.40300, COM.40475, and COM.40500

Test method verification is the responsibility of each testing laboratory.

  • It must be done in the location where testing will be performed and be approved by the laboratory director (or designee qualified as a laboratory director) for that site.
  • There must be records (data and written assessment) showing that the verification is separately done on each instrument.

Your sites may wish to pool their verification data to contribute to an overall verification study that is approved and signed by all the laboratory directors. Each site must run the verification specimens on the instrument(s) at its location and using its staff but may submit data to be compiled into a comprehensive report. The design and extent of this study would need to be approved by all the laboratory directors and ensure that accuracy, precision, reportable range and reference intervals are sufficiently verified on all instruments at all sites, and this must be clearly documented in the data and summary.

Your main laboratory site may perform studies on each instrument prior to distributing them to your other laboratories; however, the other laboratory sites must still perform their own test method verification studies. The depth of the verification studies is determined by the laboratory director.

Reference CAP accreditation checklist requirement: COM.40300, COM.40475.

For laboratories experiencing shortages of testing supplies (eg, viral transport media, collection swabs) during this public health emergency, the FDA has provided recommendations for alternative products that may be used based on the best available evidence and in consultation with outside experts. The recommendations are found on the FDA’s FAQs on Diagnostic Testing for SARS-CoV-2 and are updated as the FDA receives more information from laboratories and manufacturers on other validated alternatives. The laboratory may also validate other alternatives. If the laboratory chooses to use alternatives not included in the EUA assay’s instructions for use, they must be validated by the laboratory, such as through a bridging study (see below).

A bridging study involves evaluating the new component for equivalent performance using parallel testing of the same specimens with the new and original components. An example of an appropriate bridging study is described in the FDA’s FAQs on Diagnostic testing for SARS-COV-2 as follows:

  • Test 3-fold serial dilutions of SARS-CoV-2 viral materials (eg, whole genomic viral RNA or inactivated virus, etc.) in a pooled respiratory sample matrix in triplicate until you achieve a hit range of <100%.
  • If the limit of detection (LOD) is the same as the LOD for the modified authorized test, the tests may be considered to have equivalent performance.

Reference CAP accreditation checklist requirements: COM.04250, MIC.64770

Yes, providing the laboratory meets the requirements to perform high complexity testing and the media is validated by the laboratory. The use of this transport media is limited to laboratories within the same health care system and have common ownership by the parent corporation. Laboratories using the transport media within these limitations are not required to notify the FDA under these circumstances.

Laboratories seeking to distribute transport media to entities that are not within the same corporate organization and share common ownership by the same parent corporation must follow sections IV.B and IV.C of the FDA Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 Public Health Emergency of VTM and PBS/Saline transport media devices (sections IV.B and IV.C).

Refer to the following resources for more information:

Reference CAP accreditation checklist requirements: MIC.64770, MIC.13275

Laboratories performing tests under emergency use authorization need to perform the test according to the authorized instructions for use. The FDA has allowed certain types of modifications relating to shortages of collection and testing supplies through the use of a bridging study. The FDA has not objected to modifications to the specimen type (eg, nasopharyngeal versus saliva) where the new specimen type has been previously authorized for another test of the same technology (eg, all nucleic amplification tests are considered to have the same technology) and the EUA test has been validated for the new specimen type.

Modifications to tests that have not been authorized under the test’s EUA must be validated by the laboratory and should not be represented by the laboratory as being authorized by the FDA.

The FDA’s Molecular Diagnostic Templates include recommendations for validation of a new specimen type (i.e., alternative, non-respiratory specimens).

Laboratories developing tests for COVID-19 must establish accuracy, precision, reportable range, reference intervals, analytical sensitivity, and analytical specificity (interferences), as applicable. The tests must be validated at the laboratory performing the test.

Download a CAP example template for analytical validation by searching logging into e-LAB Solutions Suite and searching for “analytical validation".

On August 19, 2020, the US Department of Health and Human Services (HHS) published a notice indicating that premarket review by the FDA will not be required for laboratory-developed tests (LDTs) for COVID-19. The FDA is currently not reviewing applications for EUA for LDTs. If a laboratory decides to use an LDT without EUA, the following important conditions apply:

  • The test is not eligible for PREP (Public Readiness and Emergency Preparedness) Act coverage, which provides immunity from liability for testing developed as a countermeasure for the COVID-19 pandemic.
  • The test is subject to the CAP requirements and CLIA regulations for the following:
    • Establishing and validating test performance specifications of LDTs prior to beginning patient testing (42CFR493.1253)
    • Holding the appropriate CLIA certificate type (Certificate of Accreditation, Certificate of Compliance, or Certificate of Registration)
    • Performing tests by personnel qualified to meet high complexity testing requirements.

The FDA has created templates for molecular, antigen, and serologic methods that may be helpful to laboratories developing COVID-19 tests. If you are in a state that has chosen to authorize laboratories within that state or territory to develop and perform tests for COVID-19, your laboratory should contact your state for instructions. The FDA FAQs include a current listing of the states that are participating.

Reference CAP accreditation checklist requirements: COM.40350, COM.40475, COM.40500, COM.40830, COM.40840, COM.40850, GEN.20361, GEN.54750

Quality Control and Proficiency Testing

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The following is the CAP’s current guidance for performing quality control for COVID-19 testing during the COVID-19 health care crisis:

  • For EUA tests authorized for use in a patient care setting, perform quality control following the manufacturer’s instructions, at minimum. The FDA deems these tests to be CLIA waived tests. No IQCP is required.
  • For EUA tests authorized for use by moderate or high complexity laboratories only, perform quality control following the manufacturer’s instructions, at minimum. These tests are considered to be nonwaived tests; however, no IQCP is required unless the manufacturer does not define conditions for reduced external QC frequency in its instructions for use.

If the manufacturer does not define conditions for reduced external quality control in its instructions for use (eg, states to perform external QC in accordance with applicable federal, state, or local accreditation requirements), the laboratory must:

  • Perform external QC following the default CLIA frequency (eg, two levels of QC each day of testing) OR
  • Implement an IQCP if it wishes to reduce the frequency of external QC. Written QC plans must be approved by the laboratory director prior to implementation. 

Please note that all laboratories performing nonwaived testing must perform external QC with each new lot and shipment of reagents.

Visit the CAP’s IQCP Toolbox for resources to develop an IQCP by logging into e-LAB Solutions Suite and searching for “IQCP Toolbox.”

Reference CAP accreditation checklist requirements: MIC.65200, COM.30450, COM.50300, COM.50400, COM.50500

For tests authorized under EUA, laboratories must follow the manufacturer’s instructions for external and internal quality control at minimum. If the manufacturer’s instructions allow the use of the manufacturer’s control material alone as the external control, the laboratory would be considered in compliance. The laboratory may run additional controls for IgG or IgM if desired.

The CAP has new PT programs for COVID-19 testing. Details on these products are included on cap.org.

  • COV2 - Detection of SARS-CoV-2 by nucleic acid amplification testing
    • Specimens are non-infectious and contain the whole SARS-CoV-2 genome, providing sequence targets across all assay platforms.
  • COVS – Detection of total, IgG, IgM, and IgA antibodies to SARS-CoV-2
    • Specimens are non-infectious donor-based serum and are compatible with most testing platforms.
  • COVAG – Detection of the antigen of the SARS-CoV-2 virus
    • Specimens contains inactivated SARS-CoV-2 virus.

The CAP also has a Quality Cross Check program COV2Q for SARS-CoV-2 molecular testing that can be used to monitor the performance and assess the comparability of up to three instruments.

You can order these programs today in the online store or by contacting the CAP at 800-323-4040. Laboratories in countries served by a designated CAP distributor should contact the distributor’s customer service department to order these products.

Laboratories should check with their local authorities to determine if permits are required. Supporting documentation is available from the CAP upon request.

Alternatively, laboratories must perform alternative performance assessment to determine the reliability of analytic testing at least semiannually. It is the responsibility of the laboratory director to define alternative performance assessment procedures and the criteria for successful performance in accordance with good clinical and scientific laboratory practice. Common alternative performance assessment procedures include participation include split sample analysis with another laboratory, split sample analysis with an established in-house method, use of assayed materials, and other suitable and documented means.

Reference CAP accreditation checklist requirement: COM.01500.

A physical signature is required on the PT attestation form. Your laboratory may consider the following alternative approaches for having the form signed:

  • Faxing the form or scanning it to be sent by email to the director to be physically signed and returned to the laboratory
  • Having the laboratory director delegate the task to another qualified individual
    • For high complexity testing, it may be delegated to an individual meeting the qualifications of a technical supervisor (GEN.53400). For the specialties of Histocompatibility, Cytogenetics, and Transfusion Medicine, refer to specific requirements for the qualifications of section directors/technical supervisors in the associated checklists (HSC.40000, CYG.50000, and TRM.50050).
    • For moderate complexity testing, it may be delegated to an individual meeting the qualifications of a technical consultant (GEN.53625).
  • Delaying the signing of the form until after the PT event is over. The form does not need to be signed prior to sending the results to PT provider. It can be completed after the event when the results are being reviewed.

Reference CAP accreditation checklist requirement: COM.01400

Yes, during the COVID-19 health care emergency, the CMS memorandum QSO-20-21-CLIA allows pathologists to work remotely (eg, at home) to report laboratory data/slides/images under a primary site’s CLIA number under specific conditions defined in the memorandum. This includes the performance and review of PT at remote sites because the parties are acting under a single CLIA number. Test sites that already have a separate CLIA number than the primary site are excluded.

Reference CAP accreditation checklist requirement: COM.01900, All Common Checklist

Yes, during the COVID-19 public health emergency, the CMS memorandum QSO-20-21-CLIA also allows other laboratory professionals, such as cytogeneticists performing ISH scoring or karyotyping, to perform testing remotely (eg, at home) under a primary site’s CLIA number under specific conditions defined in the memorandum. This includes the performance and review of PT at remote sites because the parties are acting under a single CLIA number. Test sites that already have a separate CLIA number than the primary site are excluded.

Reference CAP accreditation checklist requirement: COM.01900, All Common Checklist

You will still need to submit data at your earliest convenience by accessing your result form on cap.org via e-LAB Solutions Suite Lock . Use the following exception code to avoid penalty on your evaluation.

  • Code 11 (Unable to analyze):
    Use code 11 to indicate your laboratory was or is closed due to the COVID-19 pandemic or was unable to analyze the specimens (eg, instrument not functioning, reagents not available). You do not need to call the CAP to use this code.

Include a note in the “Use of Other” section of the attestation page. The exception code bubble that you select will apply only to the result area(s) left blank.

You will still need to submit data at your earliest convenience by accessing your result form on cap.org via e-LAB Solutions Suite Lock . Use the following exception code to avoid penalty on your evaluation.

  • Code 33 (Specimen unsatisfactory):
    Use code 33 to indicate your laboratory never received a kit, if a kit was delivered with unusable material (eg, specimens no longer stable), or if the CAP was unable to fulfill your replacement request. You do not need to call the CAP to use this code.

Include a note in the “Use of Other” section of the attestation page. The exception code bubble that you select will apply only to the result area(s) left blank.

Yes. If the CAP was unable to ship your kit or if your laboratory is closed, you should perform an alternative performance assessment (APA) to determine the reliability of analytic testing. If your laboratory is currently unable to perform testing, hold the material and use it for alternative assessment when routine testing circumstances resume. If your laboratory is CAP-accredited, please refer to COM.01500 for more information on APA summarized here:

  • Appropriate APA procedures may include split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means.
  • It is the responsibility of the laboratory director to define such APA procedures, as applicable, in accordance with good clinical and scientific laboratory practice.
  • The number of specimens challenged should be equivalent to the number of specimens that the laboratory would have tested if the PT material were received.

The processing and turnaround time of some program evaluations may be slightly delayed as a result of a due date extension(s).

If a program shipment was delayed for all participants, then calendar dates will adjust. If a program shipment was held for a specific subset of laboratories with import restrictions, but still went out as scheduled for other participants, then the calendar will not adjust with a new date.

You will know if shipping is resuming when your laboratory begins to receive pre-alerts; these are the primary indicator. If a shipping restriction is lifted, but a program is unable to ship, your laboratory will receive an email from the CAP. For example, when a program cannot ship due because the material has expired.

COVID-19 Results Reporting

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All positive and negative tests performed to detect SARS CoV-2 or to diagnose a possible case of COVID-19 must be reported to the state or local public health authorities. On August 26, 2020, the Centers for Medicare and Medicaid Services issued memorandum QS0-20-37-CLIA to address updates to the CLIA regulations defined in the interim final rule, CMS-3410-IFC for the reporting of COVID-19 test results during the public health emergency. The CMS allowed a three-week grace period starting on September 2, 2020 for laboratories to come into compliance. The CMS reporting requirement does not apply to surveillance testing performed on deidentified specimens, as that testing is not subject to CLIA.

New condition level CLIA regulations 42CFR493.41 and 42CFR.493.1100 require each laboratory that performs a test that is intended to detect SARS CoV-2 or to diagnose a possible case of COVID-19 to report test results to HHS in the form, manner, timing, and frequency defined by HHS, including:

  • Positive and negative results
  • Molecular, antigen, and antibody tests performed by all methods
  • Laboratories with all CLIA certificate types (Certificate of Accreditation, Compliance, Registration or Waiver, and Provider-Perform Microscopy) regardless of location of testing.

In addition, there are new and modified CLIA regulations that address failure to report that include provisions for sanctions and civil money penalty for noncompliance with reporting. The CAP is required to notify the CMS of noncompliance with the reporting requirements identified at CAP-accredited laboratories (eg, through a complaint investigation or CAP inspection) as part of its deeming authority as an accrediting organization. The CMS may also be using other means to identify noncompliance.

Laboratories are considered in compliance with the CLIA regulation for reporting to HHS if they submit the results to the local or state health authorities. The CLIA regulation does not apply to laboratories that simply collect and refer specimens to another laboratory for testing.

Reference CAP accreditation checklist requirements: GEN.20374, GEN.41316

The HHS laboratory data reporting guidance from June 4, 2020 specifies required data elements, demographic data elements, and ask on order entry questions that need to be reported with COVID-19 test results reported to state and local health authorities. (eg, all 18 data elements, ask on order entry questions, or reporting of the results within 24 hours). While laboratories need to follow the HHS reporting guidance, compliance will not be enforced by the CMS as part of the CLIA regulation change. Laboratories should work with the state or local health departments on reporting the data. For more information refer to the CDC resource How to Report COVID-19 Laboratory Data.

The CAP will be amending its Laboratory General Checklist requirement GEN.41316 (Infectious Disease Reporting) to require laboratories subject to US regulations that perform testing intended to detect SARS-C0V-2 or to diagnose a possible case of COVID-19 to report positive and negative results to local or state health authorities. This includes molecular, antigen and antibody test methods in laboratories with all types of CLIA certificates and tests of all levels of complexity (including waived). Once this checklist revision is approved by the Centers for Medicare and Medicaid Services, it will become effective immediately for all laboratories and in all checklist editions. An eAlert will be sent to CAP-accredited laboratories to laboratories and inspectors to communicate the change.

If your laboratory performs COVID-19 testing, you will need to be prepared to answer questions on how results are reported to the state or local health authorities and provide records (electronic or paper) to confirm that all positive and negative results of applicable tests are being reported. If this process is managed by another department at your facility (eg, infection control department), alert appropriate personnel to ensure accessibility of records during inspections and availability of personnel to answer questions.

Reference CAP accreditation checklist requirements: GEN.20374, GEN.41316

If a deficiency is cited for GEN.41316 for noncompliance with COVID-19 result reporting, the CAP technical staff will investigate to determine if the deficiency must be reported to the Centers for Medicare and Medicaid Services (CMS). The CAP staff may contact the laboratory and/or inspector to get further information on the citation (eg, types of testing involved, information not reported, dates of occurrence). If the CAP determines that the laboratory was noncompliant with the CLIA regulations for COVID-19 result reporting, the CAP will notify the CMS as required and will follow up with the laboratory to ensure that reporting problems are corrected. For Department of Defense and Veterans Affairs laboratories, the CAP will also notify the relevant program office.

No, the enforcement of the CLIA regulation is only directed at the reporting of positive and negative test results. If your laboratory reports “presumptive” positive or negative results for a patient, these results must be reported if you are not performing reflex testing at your laboratory to report the results to the provider.

Reference CAP accreditation checklist requirements: GEN.20374, GEN.41316

The Health and Human Services guideline states that laboratories need to report results to the state or local health department based on the patient’s home address. The location of the health department used for reporting will not be specifically assessed to determine CLIA compliance by the CMS or the CAP. Laboratories need to work with the appropriate health departments to ensure proper reporting and follow state and local regulations.

Patients' physicians may request, or institutional policy may dictate, that test results from outside laboratories be integrated into the laboratory's primary reporting system (ie, the laboratory information system (LIS) or the institution's electronic medical record (EMR)). The laboratory director should be aware of whether results from outside laboratories are reported through the LIS or the EMR.

If such results are integrated,

  • The name and address of the outside laboratory must be available in the primary reporting system.
  • The essential elements of referred test results must be reported by the referring laboratory as received from the outside laboratory, without alterations that could affect clinical interpretation
  • There must be an indication available to the person viewing such results that they originated from an outside laboratory

Instead of integrating results into the laboratory’s primary reporting system, another option is to include the results in a section of the electronic medical record other than the laboratory database.

Reference CAP accreditation checklist requirements: GEN.41077 and GEN.41440

Neither the CAP nor the FDA have mandated a specific disclaimer to be included with results for EUA COVID-19 tests; however, many laboratories are including disclaimers with patient results to provide transparency about the testing performed. They often include statements, such as:

  • The test has not been FDA cleared or approved.
  • The test has been authorized by the FDA under an EUA for use by authorized laboratories.
  • The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.”

Your laboratory should determine appropriate mechanisms for communicating the limitations of the testing to your clinicians to ensure proper interpretation and use in patient care. If your state or other regulatory authority requires a specific disclaimer statement, it must be included with the patient results or using another approved mechanism.

For validated COVID-19 testing performed using kits developed by commercial manufacturers or laboratories prior to EUA submission to the FDA, the FDA recommends that test reports include a general statement that the test has been validated but FDA’s independent review of the validation is pending.

For serologic COVID-19 testing, the FDA Policy Section D on serology tests recommends that instructions for use and patient test reports include information that helps users and patients understand the test results, such as the following:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

It is important for clinical laboratories to understand and communicate to providers that COVID-19 serology tests are currently not recommended as an acute diagnostic and should not replace RT-PCR on upper respiratory specimens for diagnosis. The timing and degree of immune response to COVID-19 is not yet fully understood, and serology tests will be negative prior to development of antibodies which can take several days after infection with the virus.

Confirmatory testing by RT-PCR is not mandatory but may be recommended if the result of the antigen test is inconsistent with the clinical symptoms of the patient. There are several factors the laboratory should consider regarding the accuracy of antigen tests, including the sensitivity and specificity of the test, the integrity of the specimen, prevalence of infection in the community, and use of the test for screening or diagnostic purposes.

If the same test is being ordered and performed, the laboratory is not required to set these tests up in the laboratory computer system as separate tests. This makes it especially important for laboratories to have a mechanism to address variations in the reporting language for different platforms used. One mechanism that laboratories can use is to add a note to the final report with the result that provides information on the platform used and on any variations in the reporting language to aid the clinician in interpreting the result.

The laboratory must maintain good records of patient testing as to be able to identify the specific platform and test assay used for any test.

Reference CAP accreditation checklist requirements: GEN.43920, MIC.66100[LW(1]

Your laboratory must follow its own policy for reporting COVID-19 results to the clinician/ordering provider. The CAP does not require these results to be handled as critical results; however, your laboratory must have an effective reporting system to ensure that results are reported to the clinician in a timely manner.

If your laboratory defines COVID-19 results as critical results, it must follow COM.30000 (Critical Result Notification) and have records of immediate notification to the clinician or other clinical personnel responsible for the patient’s care.

Reference CAP accreditation checklist requirements: GEN.41316, COM.30000, COM.30100.

Personnel

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If the test was performed and the results verified by qualified testing personnel, results may be entered into the laboratory computer system/electronic health record by non-testing personnel trained to enter previously verified results. The laboratory must have systems for identifying errors during result entry. Results must be traceable to the individual that performed the test. For entry of results received from a referral laboratory, the report must include the name and address of the referral laboratory. Laboratories must also follow applicable state laws and regulations for the qualifications and supervision of non-testing personnel that enter patient results.

Reference CAP accreditation checklist requirements: GEN.41096, GEN.41306, GEN.54750, GEN.55450, GEN.78300, COM.04050

If the testing is standardized across the test sites at different system hospitals (ie, uses the same procedures, instruments, reagents, reporting system, etc.), it is acceptable to use the same training records for multiple sites. Each laboratory must be able to provide records showing that these individuals were adequately trained. If there are variations in how testing is performed at different sites, there must be site-specific training that addresses the variations.

Competency assessment of nonwaived testing must be performed at each laboratory where testing is performed. It is not acceptable to use records of competency assessment performed at one laboratory for another, even if there are no variations in the testing.

Reference CAP accreditation checklist requirements: GEN.54400, GEN.55450 and GEN.55500

There are no exceptions to the requirements for training and competency assessment during the COVID-19 health care emergency. It is essential that testing personnel provide accurate, reliable results for patient care.

  • Each individual performing patient testing must have training and be evaluated for proper test performance prior to reporting patient results for all new methods and instruments.
  • Competency must be assessed at least semiannually during the first year of testing and annually after an individual has performed his/her duties for one year.

Many elements of competency assessment can be evaluated during routine review of personnel throughout the year rather than designating a separate assessment process. Records of actions, such as observation of test performance, results report, instrument maintenance, review of worksheets, recording QC, performance of proficiency testing, and demonstration of appropriate corrective actions are examples of daily activities that can be used to demonstrate the required elements of competency. Competency assessment policies and procedures must outline how routine reviews can be used and recorded to evaluate competency.

With this said, the CAP recommends that you document delays and problems that occur due to the COVID-19 health care emergency. This will be helpful later for evaluating reasons for the occurrence and for tracking items that may need to be completed.

Reference CAP accreditation checklist requirements: GEN.55450 and GEN.55500

The CAP recognizes that direct observation of testing personnel for competency assessment during the COVID-19 health care emergency may present some challenges, especially with the need for social distancing.

Some options that your laboratory may consider include:

  • Performing direct observation from a safe, reasonable distance and/or
  • Having the individuals involved wear appropriate PPE that would be used when testing or collecting a specimen

The use of virtual, remote review, or simulations of direct observations are not allowed (eg, Skype, Zoom, video).

If your laboratory has additional time until the competency assessment is due, you may consider completing the other competency assessment elements and delaying the direct observation portion; however, the CAP has not been authorized to give extensions for completing competency assessments. Many elements of competency assessment can be evaluated during routine review of personnel occurring throughout the year rather than designating a specific process.

With this said, the CAP recommends that you document delays and problems that occur due to the COVID-19 health care emergency. This will be helpful later for evaluating reasons for the occurrence and for tracking items that may need to be completed.

Reference CAP accreditation checklist requirements: GEN.55500, POC.06875 and POC.06910

Review the personnel qualifications defined in the Laboratory General Checklist to identify the qualifications needed to perform testing in your laboratory.

The applicable personnel requirements are based on the complexity of the test performed.

  • Tests authorized under the FDA’s EUA process - The Letter of Authorization for each EUA assay defines the setting in which the test may be used. Many are authorized for use in moderate and high complexity laboratories. If a test is also authorized for use in a point-of-care setting, it is deemed to be CLIA waived.
  • All other types of testing are considered high complexity testing. This includes:
    • Tests with FDA notification, pending EUA
    • State-authorized assays
    • WHO EUL assays
    • Laboratory-developed serology tests without EUA

The complexity of tests with EUA can be found on the FDA website.

Reference CAP accreditation checklist requirement: GEN.54750

Because a specific CMS specialty has not been defined for COVID-19 testing, it is the laboratory director’s responsibility to determine the adequacy of the experience of the technical supervisor (high complexity testing) or technical consultant (moderate complexity testing) to supervise nonwaived COVID-19 testing. At minimum, the technical supervisor or technical consultant must meet the CLIA educational requirements AND have the required amount of laboratory experience performing or supervising testing based on the specific testing to be performed in either:

  • The clinical specialty/subspecialties related to the COVID-19 testing performed, such as microbiology, virology, immunology, or chemistry OR
  • The methods used to perform the testing, such as PCR or immunoassays.

Reference CAP accreditation checklist requirements: DRA.11300, DRA.11425, GEN.53400, GEN.53625

An organized advocacy campaign led by the CAP persuaded the federal government to allow pathologists to work remotely during the COVID-19 health care emergency. Under the CLIA regulations, a CLIA license is needed wherever a pathologist is physically sitting when making a primary diagnostic interpretation.

On March 26, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum, QSO-20-21-CLIA, to expand its enforcement discretion to adopt a temporary policy that will allow pathologists to work remotely to report laboratory data/slides/images under certain conditions to promote innovative uses of technology to increase testing capacity and avoid exposure risks to health care providers, patients, and the community.

With this temporary change, the CMS will not require temporary testing sites (locations used to perform laboratory testing such as a pathologist’s home) to obtain a separate CLIA certificate provided that:

  • The designated primary site or home base has a current CLIA certificate (of registration, compliance, or accreditation).
  • The scope of the work falls within the primary site’s certificate.
  • The temporary site complies with other applicable federal and state laws, including the Health Insurance Portability and Accountability Act (HIPAA).

The guidance does not apply to pathologists who have already obtained CLIA certificates for their home or other locations separate from the primary testing site.

Reference CAP accreditation checklist requirement: GEN.41303, Laboratory General - Telepathology and Remote Data Assessment section

Yes, other types of personnel, such as cytotechnologists, toxicologists, and cytogeneticists may also review slides/data/images remotely at a temporary location during this time without obtaining a separate CLIA number. The same rules mentioned above for pathologists also apply to testing performed by these individuals.

With this temporary change, the CMS will not require temporary testing sites (eg, an individual’s home) to obtain a separate CLIA certificate provided that:

  • The designated primary site or home base has a current CLIA certificate (of registration, compliance, or accreditation).
  • The scope of the work falls within the primary site’s certificate.
  • The temporary site complies with other applicable federal and state laws, including the Health Insurance Portability and Accountability Act (HIPAA).

The guidance does not apply to situations where a separate CLIA certificate was already obtained for a home testing site or other location separate from the primary testing site.

Reference CAP accreditation checklist requirement: GEN.41303, Laboratory General - Telepathology and Remote Data Assessment section

The personnel qualifications defined in the CLIA regulations do not apply to the collection of specimens. If your state has specific personnel regulations or licensure requirements for personnel collecting nasopharyngeal specimens, they must be followed.

Individuals collecting specimens must be appropriately trained to perform this duty. The training must include considerations for the safety of the procedure (for the employee and the patient), as well as the adequacy of the specimen for testing. Laboratory personnel that have direct contact with suspected COVID-19 patients should follow the CDC’s recommendations for personnel protective equipment PPE for health care providers while in the presence of these patients. The following CDC guidelines contain important information:

Reference CAP accreditation checklist requirement: GEN.55450, GEN.73300, GEN.74100, GEN.74200.

Safety

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For testing procedures with a high likelihood to generate aerosols or droplets, use either a certified Class II Biological Safety Cabinet (BSC) or additional precautions to provide a barrier between the specimen and personnel. Examples of these additional precautions include PPE, such as a surgical mask or face shield, or other physical barriers, like a splash shield; centrifuge safety cups; and sealed centrifuge rotors to reduce the risk of exposure to laboratory personnel. If using a BSC, refer to the CAP’s Best Practices for Using Biological Safety Cabinets While Testing for COVID-19 tool to ensure safety.

For point-of-care testing, use Standard Precautions to provide a barrier between the specimen and personnel during specimen manipulation.

The CDC recommends performing site-specific and activity-specific biosafety risk assessments to identify and mitigate risks and determine if enhanced biosafety precautions are warranted based on situational needs, such as high testing volumes, and the likelihood to generate infectious droplets and aerosols.

Please refer to the CDC website for the most up-to-date guidance, including:

In addition, the Occupational Safety and Health Administration (OSHA) published a document Guidance on Preparing Workplaces for COVID-19, which provides guidance for defining the level of employee risk and steps to be taken to reduce the level of risk and protect workers.

Reference CAP accreditation checklist requirements: GEN.74100 and MIC.19840

Anyone collecting specimens for COVID-19 testing must be appropriately trained and must follow the manufacturer’s instructions.

Personnel that have direct contact with suspected or confirmed COVID-19 patient should follow the CDC’s recommended PPE for health care providers while in the presence of these patients.

For CDC recommendations, refer to:

Reference CAP accreditation checklist requirements: GEN.40470 and GEN.55450

The US Department of Transportation recently released a Safety Advisory Notice for the Transportation of COVID-19 Diagnostic Samples that classifies patient specimens for SARS-CoV2 diagnostic testing as UN3373, Biological substance, Category B. Proper training of personnel on packing and shipping specimens must be done in accordance with the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulations. Review the safety advisory for details on packaging requirements, such as the use of:

  • Triple packaging (leakproof primary and secondary receptacles, and a rigid outer packaging)
  • Absorbent materials placed between primary and secondary package
  • Package capability requirements to maintain integrity while shipping
  • Required markings on outer packaging and overpack markings
  • Emergency response information.

For couriers transporting specimens (GEN.40515), these requirements for packaging and shipping of infectious substances do not apply. The couriers need to be trained on handling specimens for the specimen type and distance transported, but they may not actually be doing packaging.

Reference CAP accreditation checklist requirements: GEN.40511, GEN.40512, GEN.40515

Molecular-Based Testing

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If the laboratory chooses to pool specimens for testing, the laboratory must validate this as a modification to the manufacturer’s instructions as stated in MIC.64790, unless the manufacturer’s instructions for the emergency use authorization allow for the pooling of specimens for testing.

The FDA has created a Molecular Diagnostic Template for Laboratories that contains instructions for adding sample pooling to an authorized EUA test, as well as information on other considerations. The CAP encourages laboratories to carefully evaluate the manufacturer’s instructions for use and to use the FDA template if considering a testing approach using specimen pooling.

Reference CAP accreditation checklist requirements: MIC.64790, COM.40250, COM.40350, COM.40475.

If a pooled test is negative, all specimens within that pool can be presumed negative with the single test. The laboratory must report the negative results according to manufacturer’s instructions. The report must indicate that the testing procedure involved specimen pooling and explain the limitations of that type of testing.

If the test is positive or indeterminate, all specimens in the pool must be retested individually. The laboratory must not report positive or indeterminate results of a pooled test to health care providers, other individuals authorized to order tests, or public health departments.

Refer to CDC’s Interim Guidance for Use of Pooling Procedures in SARS-CoV2 Diagnostic, Screening, And Surveillance Testing for more information on the use of pooling.

Reference CAP accreditation checklist requirement: MIC.66100

Yes, the CAP requires laboratories to have written procedures to monitor for the presence of false positive results (eg, due to nucleic acid contamination) for all molecular microbiology tests. This is especially important with increases in testing volumes due to the health care crisis and implementation of COVID-19 testing in laboratories that did not previously perform molecular-based testing.

To prevent contamination and false positive results, your laboratory must:

  • Have written procedures to prevent specimen loss, alteration, or contamination during collection, transport, processing, storage, and disposal of specimens.
  • Use appropriate physical containment and procedural controls to minimize carryover (eg, manipulate pre and post amplification samples in physically separate areas, minimize aerosolization during manipulation))
  • Store reagents and controls properly to minimize target DNA/RNA contamination and degradation.
  • Provide education to staff on the importance of following established protocols to prevent contamination.

Examples of how laboratories may monitor for contamination include:

  • Collecting data and monitoring statistics for significant increases or decreases in positivity.
  • Performing wipe testing to check the surrounding physical area for contamination.
  • Investigating physician inquiries about potential false positive results.
  • Using process controls to minimize the risk of contamination.

If a testing site is seeing a high number of positive results, the CAP recommends checking for false positives by testing the surrounding physical area for contamination by “wipe” tests. A wipe or swipe test can be done by:

  • Dampening a sterile swab in sterile saline
  • Swabbing the area around the testing instrument
  • Testing the swab in the same manner as a patient test is performed.

A positive result from a wipe test indicates environmental contamination. You must thoroughly cleanse the area to eliminate the contamination.

Contamination may occur even when using “closed” test systems. It is important to educate staff [AM(1] on the importance of keeping the work area clean and disinfected, following established protocols for specimen processing and handling throughout the testing process, and on proper handling and disposal of specimens and testing materials.

Reference CAP accreditation checklist requirements: MIC.63252, MIC.63318, MIC.65300, MIC.65500

Anatomic Pathology Topics

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Best practice for all grossing is to perform the testing under a biologic safety cabinet (BSC). If a BSC is not used, standard precautions must be used, which includes gloves and gown. If aerosols are likely to be produced, a face shield or N95 mask should be used also. Appropriate personal protective equipment (gloves, gowns, masks and eye protectors, etc.) must be provided and maintained in a sanitary and reliable condition in all work areas in which blood and body substances are handled and in circumstances during which exposure is likely to occur. Additionally, all personnel must remove gloves and clean hands using an effective antimicrobial method after manipulating biological samples or after each patient contact.

If using a BSC, refer to the CAP’s Best Practices for Using Biological Safety Cabinets While Testing for COVID-19 tool to ensure safety.

In addition, the CDC’s Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 is a good resource for anatomic pathology laboratories.

Reference CAP accreditation checklist requirements: GEN.74100 and GEN.74250

There should be communication between the clinicians and pathology department to identify suspected/confirmed patients prior to the frozen section (FS) procedure. The clinician(s) and pathologist(s) should discuss the value of the frozen section and the possibility of an alternative course of action.

The CAP recommends that hospitals establish a policy for frozen sections on COVID-19 positive or suspected patients. Frozen sections for COVID-19 positive/suspected patients should:

  • Be considered for patients where FS can reasonably be expected to give an accurate and actionable diagnosis for which there is a life-saving intervention (e.g. mucor infection of nasal sinuses).
  • Not be performed where the FS diagnosis will not direct a high-value intraoperative intervention.
  • Follow a contagion protocol for respiratory samples similar to that likely already available for patients suspected of having tuberculosis or advanced HIV/AIDS.

Hospitals should devise policies and processes for informing Anatomic Pathology laboratories of potential for inadvertent exposure to COVID-19 from patients confirmed to have COVID-19 after having undergone a FS assessment, so that appropriate contagion and monitoring can be sought by Pathology laboratories.

The following safety procedures should be followed:

Reference: https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html

CAP accreditation checklist requirements: GEN.74100, DRA.10700.

Clinical Pathology Topics

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CCP is collected from persons who have recovered from COVID-19 infections and have developed antiviral antibodies. One or two units of CCP are transfused to a patient with COVID-19 infection as a source of passive immunity. There is also interest in giving CCP as a temporary protective measure for non-immune persons at risk such as household members and healthcare workers. Pharmaceutical companies are planning to develop SARS-CoV-2 novel coronavirus (nCoV) immune globulin from CCP.

The FDA has determined that CCP may be effective in treating COVID-19, and it is reasonable to believe that the known and potential benefits outweigh the known and potential risks. Therefore, in the COVID-19 pandemic, CCP meets FDA criteria for an Emergency Use Authorization (EUA), which was issued on August 23, 2020. However, CCP has not been approved by the FDA and its safety and efficacy are still under review.

In principle, administration of antiviral antibody may help clear infections more rapidly. Convalescent plasma transfusions were given for other viral infections, including influenza and the coronavirus infections Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS), with mixed results. Small uncontrolled international studies of CCP have been promising enough that blood collection programs have been providing CCP as an investigational therapy under FDA oversight in the COVID-19 pandemic.

The FDA has provided considerations for CCP donor eligibility. Donors must be collected by an FDA-approved blood collection facility with standard screening and testing. In addition, CCP donors must have either a past positive nCoV test or a history of suspected COVID-19 disease with antibody in their plasma. (In some centers antibody testing is done on specimens collected at donation.) Donors must be symptom-free for >14 days before donation. Blood collection centers are providing online forms for contact information, eligibility confirmation and advance scheduling at a donor center. For plasma collections, it is preferred to collect 2 units of plasma if possible. The usual plasma donation frequency is >28 days, but some collection centers are permitting donations every 7 days over a 28-day period.

Under the terms of the EUA, an Investigational New Drug (IND) application to the FDA and Institutional Review Board (IRB) approval are not needed when CCP is used in hospitalized patients with COVID-19.

The National EAP enrolled patients from April 1, 2020 to August 28, 2020. It was an FDA-approved program for blood collection facilities to provide CCP to hospitals and physicians on an investigational new drug (IND) basis, without needing to obtain case-by-case approval from the FDA and local institutional review boards (IRBs). The clinical indication was patients >18 years of age hospitalized with severe COVID-19. The Mayo Clinic provided a central IRB-approved protocol, patient consent forms, and a system to report severe adverse events and short-term outcomes.

When the EUA is in full effect, it eliminates the need for IND or IRB approval, and thus the EAP is unnecessary. The EAP discontinued enrolling new patients on August 28, 2020.

CCP will be labeled as either High-Titer or Low-Titer CCP. In recent discussions with the AABB, the FDA estimated that about 60% of current CCP units would meet a high-titer criterion in accordance with their May 1, 2020 guidance recommending a neutralizing titer of 1:160. However, Low-Titer CCP is also authorized for use. Providers can decide whether to treat with Low-Titer Plasma using individualized assessment of benefit and risk.

Hospitalized patients with COVID-19. No other clinical criteria were given by the FDA. The FDA noted that for COVID-19 patients who are pregnant, nursing mothers or <18 years old, the safety and effectiveness of CCP have not been determined, and individualized assessment of benefit and risk should be used in the medical decision to treat with CCP.

The FDA noted that benefit is more likely when patients are treated early in their course of COVID-19.

The FDA wrote a Fact Sheet for HCPs and a Fact Sheet for Patients. Hospitals must provide these Fact Sheets to HCPs and to patients, respectively, when they are considering treatment with CCP under the EUA. Spanish translations will be available soon.

On September 2, 2020, the FDA issued a final guidance on investigational CCP, replacing the April and May guidances. The September 2, 2020 guidance permits CCP collection facilities a 90-day period of temporary enforcement discretion (until approximately December 1) to develop antibody testing, labeling and other procedures to produce CCP under the EUA. After that period, current stocks and new collections cannot be used unless they either conform to the EUA requirements or they are used under an IND with IRB approval.

The FDA is also working on establishing definitions for high titers in various antibody test systems used by blood collection facilities. This includes determination of equivalencies between sample/cutoff (S/C) ratios and neutralizing titers of >1:160 as recommended in the May 1, 2020 FDA CCP guidance. In the initial Aug 23, 2020 announcement, an S/C ratio >12 in the Ortho VITROS anti-SARS-CoV-2 IgG antibody test was cited as one example. In the communication to AABB, the FDA estimated that this correlates to an approximate titer of 1:320 to 1:640.

The FDA wants to continue patient access to CCP during the transition. Current stocks of CCP can still be used without titers as defined in the EUA, and CCP can continue to be collected under the terms of the previous FDA guidance. According to the September 2, 2020 guidance, the FDA will consider pre-EUA CCP as investigational, but IND and IRB approval will not be required for use. It is very unusual for the FDA not to require physicians to get IND approval for an investigative-status therapy.

The FDA's September 2, 2020 guidance requirements include: "The treating health care provider obtains adequate informed consent from the patient or his or her legally authorized representative for the use of the investigational convalescent plasma. Informed consent should include, at a minimum, a statement that the use of convalescent plasma is investigational and a discussion of its potential risks and benefits.

In a conference call sponsored by AABB on September 2, 2020, FDA representatives recommended against using the EUA Fact Sheets for the use of investigational plasma.

FDA rules for IND-approved clinical trials of CCP have not changed. Despite the EUA for CCP, the FDA still strongly encourages clinical trials to better inform therapy and the FDA's possible future consideration of regular approval of CCP. Single-use eIND approval, requiring FDA Form 3926 submission and local IRB approval, could still be sought for patients not qualifying for locally available clinical trials or for the EUA.

Hospitals should consult their blood suppliers for specific details of how to obtain investigational CCP in the transition period. Blood suppliers will provide information on their EUA plasma as preparations for it are made.

Product codes for CCP are now available for entry into lab information systems. 

ICCBBA has also added the following N-codes for use with EUA CCP:

  • N0137 – High titer for SARSCoV-2 antibody
  • N0138 – Low titer for SARSCoV-2 antibody.

The expiration periods are one year for frozen plasma and five days for thawed plasma at 1-6°C. Before thawing the plasma, the transfusion service should re-confirm that caregivers are ready to transfuse.

New York Blood Center Enterprises have provided information on the labeling of CCP. Orientation for blood bank personnel and transfusionists will be helpful.

Physical inventory separation of CCP units is recommended to help ensure they go only to COVID-19 patients.

Serologic tests are used to identify patients who have developed antibodies (eg, IgM, IgG) to an infectious pathogen. The following are current applications for COVID-19 serology testing:

  • Providing data on seroprevalence and for epidemiologic studies
  • Identification if an individual has been infected in the past
  • Identification of individuals with prior COVID-19 infection who may serve as potential convalescent plasma donors
  • Monitoring immune response during vaccine clinical trials.

It is important for clinical laboratories to understand and communicate to providers that COVID-19 serology tests are currently not recommended for detection of an active SARS-CoV2 infection. Clinical laboratories should continue to employ the use of SARS-CoV2 molecular tests performed from respiratory specimens for the diagnosis of acute COVID-19 infection in symptomatic patients. The timing and degree of immune response to COVID-19 is not yet fully understood, and serology tests will be negative prior to development of antibodies which can take several days after infection with the virus.

Read the following for more information on serologic testing: