Availability of Testing
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Laboratories may use the following types of tests:
- Tests cleared or approved by the FDA
- Tests authorized through the FDA Emergency Use Authorization (EUA) process
- Laboratory-developed test (LDTs)
Laboratories that are not subject to US regulations may also use the following types of tests:
- Tests listed on the World Health Organization Emergency Use Listing (EUL)
- Tests approved by internationally recognized regulatory authorities (eg, CE-marking)
Yes, the FDA’s authorization of EUAs is distinct from, and not dependent on, the US Secretary of Health and Human Services’ declarations for PHEs. Laboratories may continue to use EUA test kits as long as the FDA allows the tests to be marketed as an EUA or the FDA categorizes them.
On March 27, 2023, the FDA issued the Transition Plan for Medical Devices Issued Emergency User Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19), which indicates that the FDA will provide advance notice of termination of the EUA declaration and includes guidelines to manufacturers for obtaining FDA-clearance or approval for EUAs. Additional information on the impact of the new FDA guidance can be found on our Public Health Emergency Updates page.
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During the COVID-19 PHE, the CAP notified laboratories of the date of their inspection once it was scheduled. With the end of the PHE, the CAP is now transitioning its inspection date notification process for laboratories which are located in the US and Canada that participate in the CAP’s Laboratory Accreditation Program. To comply with federal regulations and the CAP’s current collaborative agreement with The Joint Commission (TJC), the following inspection notification process will be used for these laboratories:
- Laboratories affiliated with a Joint Commission-accredited institution will receive a one-hour notification prior to the inspection.
- Laboratories with a CLIA license having their 2nd or subsequent routine CAP inspection, which are not affiliated with a TJC accredited institution, will receive notification up to two weeks prior to the scheduled inspection.
Laboratories that have already been notified of a scheduled inspection date occurring after May 11th will have the inspection occur as scheduled.
The CAP will continue to provide notification as soon as an inspection date is set for laboratories meeting the following criteria:
- Laboratories receiving their first CAP Laboratory Accreditation Program inspection that have not joined an existing CAP accredited group
- International laboratories
- Laboratories participating in the one of the following accreditation programs:
- Biorepository Accreditation Program
- Forensic Drug Testing Accreditation Program
- Reproductive Laboratory Accreditation Program
Yes. CAP inspectors can resume visits to facility patient care areas if the facility is allowing visitors in patient care areas during the time of an accreditation inspection. If a facility is restricting visitors within the institution for any reason, the CAP recommends that inspectors comply with the facility’s visitor policies at the time of the inspection. If inspectors are not allowed in patient care areas, they should alternatively interview relevant staff outside of the patient care areas to address the necessary checklist items.
The CMS Memorandum QSO-23-15-CLIA issued May 11, 2023, states that as of the end of the public health emergency (PHE), laboratories are required to follow the manufacturer’s instructions for intended use for SARS-CoV-2 testing. The FDA has now authorized several antigen, molecular, and over-the-counter tests for use in asymptomatic individuals. If the test’s intended use is modified from what is stated in the manufacturer’s instructions for use (IFU), the test becomes high complexity and the laboratory must establish the performance specifications and ensure that testing personnel are qualified to perform high-complexity testing.
The CMS memorandum further clarifies that they will not consider it a modification of the manufacturer’s instructions for use when the IFU states that is intended for “individuals suspected of COVID-19 by their healthcare provider”, and the test is ordered by a healthcare provider for asymptomatic patients. 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.
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 following link includes guidance from the Centers for Disease Control and Prevention (CDC) on testing strategies for diagnostic testing, screening testing, and public health surveillance testing: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/sars-cov2-testing-strategies.html.
Reference CAP accreditation checklist requirement: GEN.40930
During the PHE, the CAP heard concerns from some laboratories about difficulties getting service vendors to complete scheduled maintenance for different types of equipment, such as chemistry analyzers, pipettes, and hoods. The laboratory should be able to provide records to inspectors explaining any gaps or delays, as well as the actions that were taken to communicate with vendors and to ensure the quality of the affected instrument/equipment. Inspectors will review the records and determine if the action taken by the laboratory was adequate.
Reference CAP accreditation checklist requirements: COM.30600, COM.30675
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.
For laboratories not subject to US regulations, this same information applies to tests authorized through the FDA’s EUA process and the World Health Organization Emergency Use Listing (EUL): https://extranet.who.int/pqweb/sites/default/files/documents/230207_EUL_SARS-CoV-2_Approved_IVDs.pdf. .
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.40325, COM.40475, and COM.40500
No, an EUA assay is not considered a laboratory-developed test (LDT). EUA assays are inspected with the CAP checklist requirements for FDA-cleared/approved tests. If any modifications are made to the EUA assay, the modifications must be validated by the laboratory and the assay becomes subject to requirements for modified FDA-cleared/approved tests.
Reference CAP accreditation checklist requirements: COM.40250 and COM.40350
Use of a specimen collection device or sample type not included in the manufacturer’s IFU is considered a modification and requires validation of the applicable test performance specifications (accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference intervals, and any other performance characteristics required for test performance). Modification of an FDA cleared-approved test makes it high complexity and testing personnel must meet high-complexity testing qualifications.
In cases where an EUA is revoked due to the manufacturer obtaining FDA approval or clearance, your laboratory should take the following steps:
- Determine the complexity of the test. If the test is classified as waived complexity, no further action is required, provided that the laboratory has followed checklist requirements for implementation of waived tests (COM.30980). If the test is classified as nonwaived, it is subject to the test method verification requirements (COM.40300).
- Evaluate if anything has changed in the testing process (eg, intended use, test system, reagents, procedure) or if it is simply a change of label. Your laboratory may need to contact the manufacturer to obtain documentation to clarify if changes were made and on the nature of those changes.
- If changes were made to a nonwaived test or you are unable to determine if there was a change in assay versions, your laboratory is expected to perform test method verification and maintain records of studies performed and approval for use. The extent of the study is left to the discretion of the laboratory director.
- If your laboratory confirms that there is no change to the test other than the labeling, the laboratory director should review the initial test method verification study (for nonwaived tests) to confirm its adequacy. If an abbreviated study was performed when the testing was implemented, the verification should be supplemented to meet verification requirements. In many cases, previous quality control and/or proficiency testing results may be used to complete records of verification. The test method verification study, along with any new data and approvals, must be retained.
- If the test involves the use of an individualized quality control plan (IQCP), the laboratory should also review the risk assessment and quality control plan to determine if any changes need to be made to mitigate any new risks.
For more information, please review the following article in the Journal of Clinical Microbiology: Considerations from the College of American Pathologists for implementation of an assay for SARS-CoV-2 testing after a change in regulatory status.
Reference CAP accreditation checklist requirements: COM.30980, COM.40300, and COM.50300
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 or classified as waived, the laboratory must follow manufacturer’s instructions for waived test implementation (COM.30980) at minimum.
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
COVID-19 Results Reporting
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The CARES Act authority for the US Department of Health and Human Services to require laboratory result reporting ended with the public health emergency on May 11, 2023; however, state and local regulations must still be followed. Laboratories should verify the current guidance for the reporting of COVID-19 test results to their state and local public health authorities.
Reference CAP accreditation checklist requirements: GEN.20374, GEN.41316
The CAP does not mandate the use of a specific disclaimer statement for EUA assays. The laboratory must follow the manufacturer’s instructions for inclusion of a disclaimer on the patient report, as applicable.
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Personnel qualifications for waived, moderate, and high complexity testing are defined in the Laboratory General Checklist.
The following resources can be used to determine the complexity of the testing performed:
- The FDA database for tests that have received FDA clearance or approval.
- The Letter of Authorization for tests authorized for use through the FDA’s EUA process. 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. The complexity of tests with EUA can be (found on the FDA website). All other types of testing are considered high complexity testing.
Personnel must meet high complexity testing personnel qualifications to perform the following types of testing:
- Modified FDA-cleared/approved tests
- Modified EUA assays
- Laboratory-developed tests.
For laboratories subject to California regulations, personnel performing analysis of samples to test for SARS-CoV-2 in a clinical laboratory or city or county public health laboratory may meet the personnel qualifications defined in the CLIA regulation 42CFR493.1489 for high complexity testing. California personnel licensure is not required. This exception is allowed under the Business and Professions Code 1206.7.
Reference CAP accreditation checklist requirements: GEN.54750
The CMS Memorandum QSO-23-15-CLIA issued on May 11, 2023 allows for the continued enforcement discretion permitting pathologists and other laboratory personnel to remotely review digital clinical laboratory data, digital results, and digital images accessed by VPN (or other secured network), without obtaining 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 primary laboratory’s test reports indicate the remote site location where the testing is performed. This may be done using a coding system, rather than the remote site address, on the final report.
- The primary laboratory maintains a list of staff working remotely.
The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
The guidance does not apply to pathologists who have already obtained CLIA certificates for their home site or other locations separate from the primary testing site.
Reference CAP accreditation checklist requirement: GEN.41303, Laboratory General - Telepathology and Remote Data Assessment section.
No, the enforcement discretion described in the CMS Memorandum QSO-23-15-CLIA issued May 11, 2023, does not extend to glass slides. The CMS’s rationale is that, “…a microscope and other laboratory equipment is necessary to perform the testing. The necessity of such equipment is a hallmark of a separate laboratory… Therefore, after the PHE has terminated, CMS will not continue to exercise its enforcement discretion for the review of physical slides.” If laboratories choose to continue to perform the review of glass slides remotely on a routine basis, they will need to obtain a CLIA certificate.
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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. Additional information can be found on the CDC website.
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
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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.
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 contamination.
Contamination may occur even when using “closed” test systems. It is important to educate staff 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
Laboratories using different nonwaived instruments to detect the same analyte must compare them against each other at least twice a year for comparability of results. This requirement does not apply to tests classified as waived testing.
COVID-19 testing performed by two of the same or different nucleic acid amplification (NAA) instruments must be compared. COVID-19 tests performed using an NAA molecular assay and an EIA antigen assay do not need to be compared.
The laboratory may use previously tested patient samples, quality control samples from the same manufacturer and lot number, or CAP Quality Cross Check samples for the comparability study.
Reference CAP accreditation checklist requirement: COM.04250
Clinical Pathology Topics
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CCP is collected from persons who have recovered from COVID-19 infections and have developed antiviral antibodies. The FDA has limited the use of COVID-19 convalescent plasma to units with high titers of anti-SARS-CoV-2 antibodies. Units of CCP are transfused to a patient with COVID-19 infection as a source of passive immunity.
The FDA has determined that CCP with high titers of anti-SARS-CoV-2 antibodies may be effective in treating COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. Clinical dosing may first consider starting with one unit of COVID-19 convalescent plasma (about 200 mL), with administration of additional convalescent plasma units based on the prescribing physician’s medical judgment and the patient’s clinical response. The most recent FDA guidance was issued on January 7, 2022, and is to continue for 180 days after expiration of the Public Health Emergency Declaration on May 11, 2023.
CCP has not been approved by the FDA and its safety and efficacy are still under review. CCP is an investigational product and must be administered under an emergency use authorization (EUA) or an investigational new drug (IND) authorization. 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).
There are a limited number of facilities that collect CCP as the demand has significantly diminished. Also, it is likely that with the expiration of the PHE in May 2023, there will be further decline in collection sites.
Persons who received vaccine and never had known SARS-CoV-2 infection cannot donate CCP. The efficacy of vaccine-induced antibodies for CCP therapy is unknown. Patients who received monoclonal antibody therapy cannot donate CCP until three months after that therapy.
Patients who recovered from COVID-19 infection proven by a positive diagnostic test and were subsequently vaccinated can donate CCP within six months after symptom resolution.
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. These Fact Sheets were updated with the February 4, 2021 letter of authorization to reflect the current patient eligibility, and earlier versions should no longer be used. New Fact sheets in Spanish, Chinese, and other languages may be forthcoming.
Hospitals should consult their blood suppliers for the current status of CCP availability. The FDA is allowing discretion of enforcement of the EUA requirements until May 31, 2021. Until then, use of investigational CCP is permitted from prior stocks. After May 31, 2021, all CCP must conform to EUA high-titer requirements.
The FDA does not require any blood donation deferral period after the current SARS-CoV-2 vaccines. Some blood centers are electing to have a brief deferral period in case of side effects from the vaccine.