COVID-19 Testing What Dentists Need to Know
- Updated:
- April 2020
- Topic:
- Admin/Record Keeping/Charting
COVID-19 Testing—What Dentists Need to Know
On April 9, 2020, the CDC released a bulletin clarifying the CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests under Emergency Use Authorizations. It is important to note that this directive pertains only to the test itself. (https://www.cdc.gov/csels/dls/locs/2020/fda_clarifies_clia-waived_status.html)
This waiver does not relieve any offices of requirements for registration under the Clinical Laboratory Improvement Amendments (CLIA). Note that the release states, "For the duration of the national emergency declaration for COVID-19, such tests can be performed in any patient care setting that operates under a CLIA Certificate of Waiver or Certificate of Compliance/Certificate of Accreditation." The statement itself indicates a CLIA Certificate is required to perform such tests.
To completely understand this directive, it may be helpful to review CLIA certification requirements and classifications. Complete information on CLIA is found on the following websites:
- Center for Disease Control (CDC) (https://www.cdc.gov/clia/index.html)
- Centers for Medicare and Medicaid Services (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA)
- US Food and Drug Administration (https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia).
- In addition, we have extensive information regarding CLIA requirements in our publication Medical Dental Cross Coding with Confidence. https://practicebooster.com/store.asp
Our intent in this article is to provide a summary of CLIA regulations applicable to most dental practices. To that end, let's first look at CLIA's definition of a laboratory. The legislation referred to as "Clinical Laboratory Improvement Amendments of 1988" states the following.
SEC. 353. (a) DEFINITION.—As used in this section, the term 'laboratory' or 'clinical laboratory' means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
(b) CERTIFICATE REQUIREMENT.—No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
Under this definition, a physician's office is subject to CLIA when laboratory testing is performed in the facility and, as such, is required to obtain a certificate to perform testing. Certificates are issued based on the complexity of tests performed in the facility. The levels of certification are:
- Certificate of Waiver (CW)
- Certificate for Provider-Performed Microscopy (PPMP)
- Certificate of Registration (COR)
- Certificate of Compliance (COC)
- Certificate of Accreditation (COA)
Typically, a dental practice will require only a Certificate of Waiver (CW). The CW permits a laboratory to perform only waived tests (more about waived tests to follow). Currently, the fee for a CW is $180 and is valid for two years. Routine on-site surveys are not required for a CW unless there is a complaint. Along with enrolling in the CLIA program and paying the fee, a laboratory must follow the manufacturer's instructions for test performance.
A Certificate of Waiver is not to be confused with a waived test. So, what is a waived test? The FDA categorizes all laboratory tests based on the complexity of performing and interpreting each specific test. These categories are defined below.
Waived Complexity
Waived tests are so simple and accurate that little risk of error exists when performed correctly. For example, a saliva test performed chairside by the dental professional is considered a waived complexity. Another example of this is the use of a glucometer. Dipstick urine tests and urine pregnancy tests are also in the waived category. The FDA maintains a list of all waived tests. Most testing performed in a dental practice fall into this category.
The term "waived complexity" applies to the clinical expertise required to perform these tests and should not be interpreted to mean CLIA certification is not required. CLIA regulations apply to all facilities performing testing on specimens obtained from humans.
Moderate Complexity
Tests considered moderate complexity are typically those that are available on advanced automated clinical laboratory equipment. These include but are not limited to: blood tests such as electrolyte profiles, chemistry profiles, and complete blood count. This category also includes tests requiring provider-performed microscopy. Any microscopic evaluation performed by the dentist meets the definition of moderate complexity.
High Complexity
High complexity tests require clinical laboratory expertise beyond normal automation. One example is pathologic examination of tissue samples or body fluids. This level of complexity is typically not performed in the dental office setting.
In March the FDA issued an Emergency Use Authorization (EUA) for a point-of-care COVID-19 diagnostic test. This EUA allows the FDA to release this test quickly, bypassing the usual process of classification. The notification of April 9, 2020, simply clarifies this new test as temporarily being classified as waivered, thereby allowing all laboratories with a CLIA certification to perform this specific COVID-19 test. Note that the April 9th notice specifies this EUA and classification applies only to the Point-of-Care SARS-CoV-2.
A point-of-care test is one which is performed in the facility where the specimen is taken. Results are delivered to the patient in the facility during the visit. This would be similar to the "quick strep" testing we are familiar with.
To date, very few point-of-care COVID-19 tests have been made available. However, we do expect the number of available tests to increase over the next few weeks. There is an expectation that eventually they will be available to dentists, who may choose to utilize this testing in their practice. In preparation for this, we suggest dentists consider applying for a CLIA Certificate of Waiver. Without this you will not be allowed to perform these tests.
The necessity for a CLIA certification was made clear by CMS in a recent FAQ sheet. Below is the statement regarding performing tests without a CLIA certification:
- Does CMS have the ability to grant my laboratory a waiver from the CLIA certification requirements so I can begin testing COVID-19 testing right away?
- We do not have the authority to grant waivers or exceptions that are not established in statute or regulation. In the absence of such authorities, in order to do COVID-19 testing you must be a CLIA-certified laboratory that meets applicable regulatory requirements.
Source: Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency
https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf
There are only two states where a CLIA certification is not required. These states are Washington and New York. Providers in all other states should contact either CMS or their state CLIA agency. CMS has excellent information on CLIA regulations, including information for applications, available here:
- https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/HowObtainCertificateofWaiver.pdf
- https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/CLIABrochure.pdf
© 2020 American Dental Support, LLC
