What testing services does Assured Bio Labs provide for USP ⟨797⟩ programs?
Assured Bio Labs provides microbiological testing and laboratory support for personnel competency and environmental monitoring programs. Services include sample incubation, bacterial and fungal colony enumeration, microbial identification, reporting, and sampling media orders.
How do I establish an account with Assured Bio Labs?
Complete the inquiry form in the Discuss Your Testing Needs section at the bottom of this page. A customer service representative will contact you to help establish your account and discuss your testing needs.
What sample types does Assured Bio Labs accept?
Environmental monitoring: We accept viable air samples and surface samples collected using contact plates, paddles, or swabs. Single-plate and dual-plate testing methods are available.
Personnel competency: We accept gloved fingertip and thumb samples collected using plates or paddles for garbing and glove hygiene competency and aseptic manipulation competency. We also accept personnel competency surface samples collected using contact plates or paddles, and media-fill samples in bags, vials, or syringes.
Can I order sampling media or get help selecting media?
Yes. Assured Bio Labs fulfills sampling media orders. Contact customer service or complete the inquiry form at the bottom of this page to discuss media appropriate for your sample types and testing program.
Which fillable chain of custody form should I use?
Use the 20-sample fillable COC for projects containing up to 20 samples. Use the 40-sample fillable COC for projects containing 21–40 samples.
Both forms are available in the Forms & Sample Submission Resources section at the top of this page.
Are completed COC examples and instructions available?
Yes. The resources section includes three completed examples:
Example 1 — Personnel Competency
Example 2 — Environmental Monitoring
Example 3 — Dual-Plate Method
You can also download the Sample Submission & COC Guide for instructions on project organization, sample labeling, required fields, and packaging.
Should personnel competency and environmental monitoring samples be submitted on separate COCs?
We recommend keeping personnel competency projects separate from environmental monitoring projects.
Submit each individual’s personnel competency samples on a separate COC with a unique project name. Organize environmental monitoring samples into clearly defined projects, such as monthly surface monitoring or viable air monitoring. This helps keep records easy to retrieve, review, and track over time.
How do I request bacterial or fungal identification?
In the COC’s Identification Requirement section, select one of the following:
- None: No microbial identification requested.
- Action-Level Exceedance: Identify growth from selected sample types when total CFU exceeds the applicable action level.
- Any Growth: Identify growth from selected sample types regardless of whether an action level is exceeded.
If identification is requested, also select the sample types to which it applies. Identification is provided to at least the genus level and, when appropriate, to the species level.
How do I submit samples to Assured Bio Labs?
Use a unique project name and match each physical sample label to its COC identifier. Seal media plates with parafilm, group samples by project in sealed plastic bags, and pack securely with protective padding.
Email your completed digital COC to customerservice@assuredbio.com and include a printed copy with your samples.
Follow the Sample Submission & COC Guide and USP ⟨797⟩ Shipping Instructions linked in the resources section at the top of this page.
What happens if my COC is incomplete?
Missing required information may place your project on hold and delay sample processing until the information is obtained. Review the Sample Submission & COC Guide before sending your samples, and contact customer service if you need help completing the form.
How long does USP ⟨797⟩ testing take?
Typical testing timelines include incubation followed by quality control review and final reporting:
- Air samples: 7 days of incubation, plus 1–2 days for QC and reporting.
- Surface samples: 7 days of incubation, plus 1–2 days for QC and reporting.
- Gloved fingertip samples: 7 days of incubation, plus 1–2 days for QC and reporting.
- Media-fill tests: 14 days of incubation, plus 1–2 days for QC and reporting.
Incubation begins on the day samples are received. Microbial identification may require additional time. Preliminary reports are issued when applicable action levels are exceeded.
Will I be notified if an action level is exceeded?
Yes. Clients are notified when microbial growth exceeds applicable action levels following the initial incubation period.
Preliminary reports are issued when contact plate samples exceed applicable action levels while media-fill testing remains in progress. A preliminary report does not replace the final report.
What information is included in my final report?
Final reports include:
- COC project and sample details.
- Total bacterial and fungal colony-forming units (CFUs).
