- What is the FROST program?
New Hampshire Department of Health and Human Services (DHHS) is collaborating with the Division of Fire Standards and Training & Emergency Medical Services (FSTEMS) to implement the First Responder Optional Screening Testing (FROST) program. The program has been created to identify asymptomatic personnel with COVID-19 by providing rapid antigen testing. First responders are at a higher risk than the general population for exposure. According to the Centers for Disease Control and Prevention (CDC), viral testing of persons without symptoms may be useful to detect early transmission of COVID-19.
- Does my department have to participate?
This program is optional to both the agency and the individual first responders.
- How many tests can my department have?
Through an MOU with DHHS, the licensed agency will be issued a set amount of tests each month based on how many they request. The request should be relevant to the number of department members on each agency to be tested. As an example, if the licensed EMS unit has thirty (30) members, the fire department has forty (40) members and the police department has twenty (20) members, than ninety (90) tests would be needed.
- What is the cost of the FROST Program?
The cost of the BinaxNOW COVID-19 Ag Card will be covered by the federal government, whereas the cost of test coordination will be covered by the State of New Hampshire
- Who do I contact for more information about the FROST program?
NH Department of Health and Human Services and the Division of Fire Standards and Training & Emergency Medical Services
Phone: (603) 271-5980 Email: FROST@DHHS.NH.GOV
- What rapid tests will be used in the FROST program?
The BinaxNOW COVID-19 Ag Card made by Abbott Diagnostics will be used.
- Who is able to perform the testing?
All licensed EMS units, with an active CLIA CoW (See CLIA specific section below), are able to conduct the testing utilizing licensed EMS providers.
- How are the samples collected?
Samples are collected in the anterior portion of the nose using a cotton-swab collector. They are self-collected by the test-taker under the guidance of the test administrator.
- Why do I need a PCR test if there is a positive finding on the BinaxNOW Ag Card test?
Especially when used in asymptomatic persons, the BinaxNOW COVID-19 Ag Card test sometimes can give false positive results, which could result in: recommendation to isolate, monitoring of close contacts for symptoms, and temporarily limit your ability to work. If you test positive using the antigen card, you must obtain a PCR test within 48 hours. The purpose of the PCR test is to determine whether the initial positive was a true positive
- Why is it preferred that I only go to Clear Choice, Convenient MD or the MMRS locations?
These locations will all release the specimen to the positive individuals department for transport to the Department of Public Health lab in Concord. The appropriate DHHS test requisition form must be utilized at the time of testing to facilitate this process.
- Do results have to be reported?
All results must be reported to the New Hampshire Department of Public Health (DPH) through either written (positive) or electronic (negative) forms.
- Why separate methods of reporting?
In an effort to better track the results, all positive reports must go directly to the DPH Epidemiological team. This is why they must be faxed as indicated on the form. Negative findings can manually be entered into the database for tracking purposes.
- Is all individual members information protected?
Through either method of reporting, a secured format is used and all personal protected information (PII) is safeguarded.
- What is CLIA?
The Clinical Laboratory Improvement Amendments Act (CLIA) is a federal law signed into effect in 1988. The goals of the act are to establish universal standards for all medical laboratory testing.
More information can be found here, https://www.cdc.gov/clia/
- What is the CLIA waiver?
Because CLIA is a federal requirement for all entities that are performing certain tests but are not a laboratories they, must still comply with the standard. The CLIA Certificate of Waiver (CLIA CoW), enables such entities to perform tests that have been waived by the Federal Drug Administration (FDA). The waiver does not waive the requirement of CLIA, it merely allows for the performance of waived tests.
More information can be found here, https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincertificateofwaiver.pdf
- Is there a waiver to the CLIA CoW?
There is no waiver to the CLIA CoW. All entities, including Emergency Medical Services (EMS), must comply.
- How long is the CLIA CoW good for and is there a fee?
The CLIA CoW is good for a period of two (2) Years at a current cost of $180.
- What happens if I don’t comply with the CLIA requirement?
Failure to comply with the CLIA requirement has several serious implications to include daily fines by the federal government as well as potential loss of the ability to bill through Medicare and Medicaid.
- What tests are waived that EMS is providing?
There are several tests that are waived by the FDA. The most common that pertains to EMS, is blood glucose measuring. Any licensed EMS agencies (Transport and Non-Transport) that are performing blood glucose monitoring of their patients must have an active CLIA CoW in place.
More information can be found here, https://www.cdc.gov/labquality/waived-tests.html
- Will I need an additional CLIA CoW for COVID related rapid testing?
At this time the FDA has broadened the abilities to perform testing that would normally be required to have CLIA authorization or CLIA CoW in place through the Emergency Use Authorizations (EAU).
More information can be found here, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-frequently-asked-questions
- Where can I find the CLIA CoW application?
- Who is the State Contact for CLIA related matters?
Health Facilities Administration
Department of Health & Human Services
129 Pleasant Street
Concord, NH 03301
FAX: (603) 271-8716