What is Legionella

Legionella is a genus of pathogenic gram-negative aerobic bacteria of the family Legionellaceae. While most species are generally harmless and found naturally in water and soil, when growing in potable and non-potable water systems, it becomes a potentially lethal human hazard. Legionnaires’ disease and Pontiac Fever are bacterial respiratory infections commonly referred to as Legionellosis, most often caused by L. pneumophila, the most pathogenic species of Legionella. Transmission can occur through inhalation of aerosols from areas such as showerheads, hot tubs, decorative fountains, cooling towers, and other devices that can generate aerosolized water droplets.


The CMS Mandate

Prevention is paramount in healthcare facilities that care for patients with compromised immune systems, as these are the patients who are most susceptible to Legionellosis. That is why, in 2017, the Centers for Medicare and Medicaid Services mandated that all Hospitals, Critical Access Hospitals and Long-Term Care Facilities “must develop and adhere to policies and procedures that inhibit microbial growth in building water systems that reduce the risk of growth and spread of Legionella and other opportunistic pathogens in water” – Centers for Medicare & Medicaid Services S&C 17-30. Since then, Assured Bio Labs has been assisting these facilities by providing annual water management plans and Legionella testing using both the CDC ELITE Method and ISO 11731:2017 required by the NYS DOH.

How to collect a sample using the CDC ELITE Method

 Collecting Potable Water Sample from a faucet

  1. The bottles you will receive are 250 mL bottles with sodium thiosulfate used to neutralize biocides such as chlorine. In order to keep your bottles sterile, do not touch the inside of the bottle or remove the sodium thiosulfate.

  2. Before collecting your sample, remove any screens, aerators, or hoses from the faucet or other water dispenser and wipe them down using ethanol or isopropanol.

  3. Turn on the water and let it run until the water is warm but not hot.

  4. Without touching the inside of your bottle, remove your cap and let the water fill until it reaches the 250 mL line on your bottle.

  5. You will then label the bottle with a sharpie and write down a sample ID of your choice and list a description of where the sample was collected (Examples: kitchen faucet, bathroom shower, etc.).

Filling out the Chain of Custody form

  1. Once you finish the sample collection process, it is time to fill out your Chain of Custody form (COC).

  2. Start by filling out your contact information at the top of the page of your Chain of Custody form. Your report will be sent to you via email so it is very important to list a correctly written email address. Write down a project name, number, and a sample collection date to help track down your sample.

  3. Write down the sample ID’s that match those on your bottle and list the location of where you collected your samples in each line.

  4. Write down any additional comments and check the box labeled “CDC ELITE (7-14 days)” unless otherwise required to perform testing according to ISO 11731:2017.

  5. At the bottom of the page, sign your name, date, and time where it says “Relinquished by”.

Shipping your sample

  1. Place your Chain of Custody form into a sealable plastic bag.

  2. Pack up your sample(s) and Chain of Custody form into a temperature-controlled container and place that container into a box to be shipped out. Please do not place ice packs into your insulated container unless otherwise required to do so. Samples should never be frozen before being shipped to our lab.

  3. Samples will need to arrive at our lab within 48 hours of sampling time (next-day preferred). If our lab does not receive the samples in time, the entire project should be repeated so make sure you plan your collection and shipping schedule.

  4. Now your samples will be ready for testing!






Our team understands the severity of this issue and is prepared to help you immediately. Just fill out and submit the form on your right-hand side. We provide the sterile sample bottles with instructions. In a hurry? If you contact us before 3:00 p.m. EST we will ship your bottles for the next business day by FedEx.