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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. 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
  • Tests developed by the laboratory with submission to the FDA for EUA
  • Test authorized by the state where the laboratory is located.

Validated tests that will be submitted to the FDA for EUA may be distributed and used prior to obtaining authorization under the conditions defined in the Policy mentioned above.

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).

View a current list of tests with EUA authorization 

View a current list of tests with EUL authorization

The FDA is allowing manufacturers to develop, validate, and distribute these serology tests without EUA approval. The manufacturers must notify the FDA but are not required to submit for EUA approval, unless the serological testing is to be used as the sole basis to diagnose or inform infection status. The FDA maintains a listing of available tests on its FAQs on Diagnostic Testing for SARS-CoV-2.

Laboratories may use these serology tests; however, they must be validated by the laboratory as a laboratory-developed test (LDT). LDTs are considered high complexity testing. Therefore, the laboratory must have the appropriate CLIA certificate type (Certificate of Accreditation, Certificate of Compliance, or Certificate of Registration) and testing personnel must meet high complexity personnel qualifications. Please review applicable requirements in the All Common Checklist for validation of an LDT and requirements for personnel qualifications in the Laboratory General Checklist.

In addition, laboratories are required to include the following information on patient reports:

  • This test has not been reviewed by the FDA.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • 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

Reference CAP accreditation checklist requirement: COM.40350, COM.40500, COM.40850, GEN.54750, GEN.20361.

General 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

Serology assays:

  • nCOV 2019 antibodies

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 ofAuthorization for your specific test on the FDA website.
  • You will not be able to add the nonwaived EUA activity to an existing point-of-care section. Instead, create a new section unit and add the appropriate nonwaived activity.
  • If your laboratory’s application/reapplication opened prior to 4/6/2020, you may not see the activities listed in Organization Profile. If the activities do not appear, 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.

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 for a period of three months or less, 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 or for greater than three months, 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 for three months or less.

  • Assign a member of your laboratory staff to manage CAP notifications related 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.

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

Test Method Validation/Verification

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Laboratories using an unmodified EUA test kit must verify the test method performance specifications (accuracy, precision, reportable range, and reference intervals), as applicable at their own laboratory prior to beginning patient testing. The laboratory may use information published in the manufacturer’s package insert and other published literature for some aspects of the study (eg, interferences). 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 and your laboratory director (or designee meeting CAP director qualifications) must approve the verification study prior to testing (COM.40475).

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. Patient specimens can be altered (eg, spiked with control materials). The CAP encourages laboratories to continue to evaluate assay performance as testing continues and more positive specimens become available for verification studies.

For analytic interferences (COM.40500), the manufacturer or Centers for Disease Control may be able to provide a list of interfering substances.

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.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. This can be accomplished through the use of a bridging study where the new component is evaluated for equivalent performance using parallel testing of the same specimens with the new and original components.

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

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".

Laboratories subject to US regulations must also follow FDA protocols for requesting EUA authorization or state-authorization, as applicable. The FDA FAQs on Diagnostic Testing for SARS-CoV-2 contain instructions for the EUA process. 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

Quality Control and Proficiency Testing

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During the COVID-19 health care crisis, your laboratory may perform external QC less frequently than the CLIA default frequency (ie, two levels of QC each day of testing) without an IQCP, as long as the laboratory performs QC at least as frequently as stated in the manufacturer’s package insert.

A laboratory may develop and implement an IQCP for COVID-19 tests that have an internal control process. Laboratories may not perform external quality control less frequently than stated in the manufacturer’s instructions. The written quality control plan must be approved by the laboratory director prior to implementation. 

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.50300, COM.50400, COM.50500

The CAP will be launching a PT program for COVID-19 testing. Information on ordering this program will be available soon. We are currently piloting this program to ensure a high-quality program that will work across multiple methods and laboratories.

  • The program will be for laboratories that utilize nucleic acid amplification methods to detect SARS CoV-2.
  • It will only be available to laboratories in the US and its territories due to export restrictions.
  • Two mailings will be planned for 2020, with the first to be sent in spring 2020.

The CAP is also looking at developing PT for serological COVID-19 testing.

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.

Personnel

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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

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 approved under the FDA’s EUA process do not have test complexity assigned directly by the FDA; however, 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. .
    • Review the Letter of Authorization on the FDA website for each test performed by your laboratory and ensure that personnel meet applicable qualifications.
  • State-authorized assays, WHO EUL assays, and laboratory-developed tests are considered high complexity testing.
  • COVID-19 serology assays that have not been through an EUA approval process are considered high complexity testing.

Reference CAP accreditation checklist requirements: GEN.54750

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 requirements: 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 requirements: GEN.41303, Laboratory General - Telepathology and Remote Data Assessment section

Safety

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For 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. Site- and activity-specific biosafety risk assessments should be performed to determine if additional 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.

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.

  • When collecting diagnostic respiratory specimens (e.g., nasopharyngeal swab) from a possible COVID-19 patient, the following should occur:o
    • Personnel in the room should wear an N-95 or higher-level respirator (or facemask if a respirator is not available), eye protection, gloves, and a gown. 
    • The number of personnel present during the procedure should be limited to only those essential for patient care and procedure support. Visitors should not be present for specimen collection.
    • Specimen collection should be performed in a normal examination room with the door closed.
    • The procedure room surfaces must be promptly cleaned and disinfected following appropriate environmental infection control procedures.
  • Additional information can be located on the CDC webpage.

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

Molecular-Based Testing

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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.

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

  • Have written procedures to prevent specimen loss, alteration, or contamination during collection, transport, processing and storage.
  • 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.
  • Collect data and monitor statistics for positive results. An unexpected increase may signal the need to check for possible contamination. 
  • Investigate physician inquiries about potential false positive results.

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

Anatomic Pathology Procedures

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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.

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

In general, frozen sections on patients suspected of having COVID-19 should be avoided, if possible. There should be communication between the clinicians and pathology department to identify suspected/confirmed patients prior to the frozen section procedure. The clinicians and pathology department should discuss the value of the frozen section and the possibility of an alternative course of action.

The CAP recommends that hospitals strictly limit performing frozen sections on COVID-19 positive patients. Frozen sections for COVID-19 positive patients should:

  • Be considered for patients with life-threatening conditions.
  • Are not recommended for elective procedures or on any cases in which the diagnosis can wait until the permanent section without harm to the patient.

The following safety procedures should be followed:

  • The number of persons exposed at the time of testing should be no more than one to two persons.
  • Personnel should wear appropriate protective equipment (gloves, apron, eye protection and a surgical mask) at all times.
  • A biologic safety cabinet should be used, if possible.

Reference CAP accreditation checklist requirement: GEN.74100, DRA.10700.