
Qualified CMS Laboratory for Hospitals, Critical Access Hospitals, Long Term Care Facilities, and Commercial Facilities
Accreditations: – CDC ELITE Laboratory #5001635 ✓ – New York State Department of Health ELAP Approved Laboratory #12050 ✓
Our goal is to detect Legionella bacteria at the source swiftly, therefore empowering our clients to implement corrective action measures to ensure occupants and the general public are safe from infection.
Culture Isolation & Analysis
Assured Bio operates under ISO 11731 for Legionella isolation from water sources (7-14 day turnaround time). We maintain CDC ELITE Proficiency (#5001635) , AIHA-LAP, LLC accreditation (Lab ID# 183867) (10-14 day turnaround time), and New York State Department of Health Environmental Laboratory Approval Program ELAP ID# 12050.
In order to isolate Legionella we use 22 mm, 0.2 µm pore size, poly-carbonate filters inside stainless steel housing to concentrate each sample. Once concentrated, the sample is diluted with remaining sample water and applied to media (BCYE (Buffered Charcoal Yeast Extract) with appropriate supplementation) for culture. BCYE is the agar of choice for legionella isolation because the legionellaceae organism is nutritionally fastidious, drawing energy from amino acids rather than carbohydrates. Once the plates of contaminated media are prepared, they will undergo an incubation period. Incubation creates an environment in which the organism will thrive, producing an identifiable sample.


Additional Legionella Testing:
Assured Bio also offers advanced PCR analysis upon request.
Each sample that is processed by Quantitative Polymerase Chain Reaction (qPCR) utilizes two assays for the identification of Legionella bacteria in environmental samples. DNA analysis is 99.9% accurate. The two assays available will tell you whether any species of Legionella is present, whether it is Legionella pneumophila, and give you a concentration of both. ISO 11731 is followed through filtration, since ISO 11731 does not address DNA analysis, post filtration steps follow U.S. E.P.A DNA extraction and quantification recommendations. However all steps of the process maintain quality measures under ISO 17025 and AIHA accreditation standards. DNA testing is fast and highly accurate. Standard turnaround time upon sample receipt is 2-3 business day, but same day results are typically available for an extra fee (please call or e-mail the lab when sending expedited samples).
If your DNA analysis comes back with a species of Legionella not identified as pneumophila, Assured Bio Labs can sequence your results and identify what species is present. We can also determine species serotype if requested.
Customized Water Management Plan
Long Term Care facilities that conduct Legionella testing with Assured Bio Labs are eligible to receive a complimentary water management plan. Once your facility has received its scheduled testing date, you will be sent your new water management plan along with your bottles to send your samples in. Our customized water management plan extends to in-depth knowledge of all Legionella regulations and guidance in accordance with the Centers for Medicare & Medicaid Services (CMS). We work closely with hospitals and Long Term Care facilities to ensure they have all protocols and documents in place to meet CMS regulations in their facilities. We understand that CMS regulations may be confusing at first. Assured Bio will ensure that your facility is on the correct path, and following CMS regulations as outlined in ASHRAE standards and the CDC toolkit. Vigilant testing allows facility managers to correct problems quickly, thereby mitigating risk to building occupants and the public. The cost of litigation and health care associated with infection is orders of magnitude greater than preventive testing. We are experts in testing and Dr. Sobek, our founder, is a microbial contamination expert and experienced in Legionella bacteria investigations. Accordingly, our clients receive the highest quality service backed by leading edge science.
Testimonials:
“I wanted to take a moment to thank you for your prompt response to our needs at my location. Your knowledge, expertise and comprehensive assessment was well appreciated by me and my team.” –Michael S., EHS Officer-Industrial
“Assured Bio Labs provided the testing that we needed to identify the source of Legionella in our facility. We stopped an outbreak dead in its tracks using their same day turnaround DNA tests.” -Melissa B., EHS Leader-Hospital Healthcare
“Thank you Assured Bio for helping us maintain a safe and Legionella free facility.” -Toni R., Principle-Long Term Care
“Getting on board with NY Legionella surveillance program was a breeze with Assured Bio’s expertise and guidance. Thank You!” -Sergio F., Building Manager-Commercial