Testing for the corona virus infection has been a topic in the forefront of our lives and we hear about it on a daily basis. Particularly with returning to work in a more “normal” setting. Dentists who are at the front-line in treating and seeing potentially ill patients want to do this in a safe way. Having the ability to test a potentially infectious individual is an intriguing idea, because we all know if you as the Doctor are exposed, then you are required to quarantine for a minimum of 10 - 14 days. This will cause another log jam in our schedules, not help those who have been waiting for more comprehensive care since the shut down, and affect our staff. It’s obvious that having the option to test patients right before treatment is initiated is an essential safety measure for the public, our staff and our families..
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| Surgical attire by Dr Sharon Pollick and Beth Marvin |
Dentists Can Test Patients:
At or around September 10,2020, the Governor of New York passed legislation about specific criteria to follow in performing POC (point-of-care) testing by authorized licensed professionals. New York State Dentists have had the ability to perform certain CLIA-waived tests on patients through the POLEP (Physician Office Laboratory Evaluation Program).
In the June 2020 edition of the New York State Dental Associations Journal I posed a hypothetical question as the topic of my article,” Do you have your COVID card?”, for individuals who have developed immunity, they may present documentation that allows them to take part in public activities. Participating with others without the fear of becoming ill or passing on the virus. We understand that a group of immune people can potentially bolster herd immunity within that group.
How to Obtain a CLIA waiver or (CoW) Certificate-of-Waiver:
CLIA waived POC tests administered by qualified providers are contracted by the states as per the (CMS) Centers for Medicare and Medicaid Services.
1. A CMS 116 application form must be completed as part of the process and can be found here and applies only to that test.
2. CLIA waiver fee $180.00 every two years.1
3. Is specific to one office location for practitioners with multiple sites with a few exceptions listed on the application.
New York State/Federal2 CLIA waived COVID-19 Test requirements:
1. New York State Governor Executive Order # 202.61 states test results must be reported to the states registry within 3 hours of the result3.
2. The patient's attendance, employment, or volunteering in a school setting, as well as the patient's address, must be reported.
CLIA waived COVID-19 Tests available to Dentists:
1. A rapid IgM/IgG blood test, known as Standard Q COVID-19 is available through Henry Schein, manufactured by SD Biosensor Inc., a global bio-diagnostic company, represented by VelocityDX in the United States.4
2. Always follow the test package insert for proper instructions on how to perform and interpret the test.
3. Detailed video Instructions on how to properly perform tests are found here on YouTube. Additionally, information on how to properly interpret those results, is included with the hopes of less interpretation errors.
4. Maintaining accuracy and reliability of waived tests in your office can’t be overstated, and it requires providers to develop and maintain good laboratory practices.5 i.e. proper specimen collection, labeling and storage. Knowing how to perform the steps to complete the test and document and communicate the results to the State. Have the ability to identify inaccurate results.
5. If this task is delegated to your staff then it is the Doctors duty to train, observe and evaluate your personnel. Also training sessions should be documented and maintained in order to show an auditor should a CMS or State official present to your office.
6. Failure to follow the instructions on a CLIA waived test could change the “intended use” of the test system as approved by FDA and result in a test that is no longer waived.
Other COVID-19 Tests:
1. The (PCR) polymerase chain reaction test which looks for molecular evidence of the virus via nasal swab.
2. The antigen test which detects the viral coat and is also obtained by a nasal swab.
Knowledge is power and allows us to comfortably proceed in situations that may otherwise cause us to dismiss a healthy patient and on the flip side, those patients we may be suspicious of being infected, can be confirmed by obtaining positive results and avoid any additional infectious exposure.
Stay safe and healthy.
The Girldoc😉
1 https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/CLIA_certificate_fee_schedule.pdf
2 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19
3 https://www.governor.ny.gov/news/no-20261-continuing-temporary-suspension-and-modification-laws-relating-disaster-emergency
4 https://www.governor.ny.gov/news/no-20261-continuing-temporary-suspension-and-modification-laws-relating-disaster-emergency
5 https://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf
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