In a move signaling stricter enforcement of personnel qualification standards, the Centers for Medicare & Medicaid Services (CMS) has clarified how laboratories must document education, training, and experience for CLIA-designated roles. This change has important implications for lab directors, technical supervisors, general supervisors, and other staff in positions requiring prior laboratory experience.
What Changed?
Note: In December 2023, CMS issued its final CLIA rule (CMS-3326-F) updating personnel requirements, with an effective date of December 28, 2024, and, as reiterated in the December 6, 2024, QSO-25-10-CLIA memo. Read the latest June 23, 2025, update here.
The update requires that all documentation supporting an individual’s education, training, and experience be provided by someone other than the individual seeking to meet CLIA personnel qualification requirements. This means that self-attested documents, such as a resume or curriculum vitae (CV), are no longer sufficient on their own.
Instead, laboratories should ensure they maintain third-party verification of training and experience for each applicable employee. Examples of acceptable documentation include:
- Signed letters on official letterhead from previous employers confirming job responsibilities
- Records of past competency assessments
- Detailed job descriptions signed by former supervisors or human resources personnel
This clarification reinforces the importance of objective, verifiable records in demonstrating compliance with CLIA’s personnel standards.
Why It Matters
Joe Kessler, Director of Recruiting, LLS
According to Joe Kessler, Director of Recruiting and Staffing at Lighthouse Lab Services, the new clarification is already being taken seriously during inspections:
“It’s clear that CMS is now enforcing this provision with increased scrutiny, particularly when it comes to roles like General and Technical Supervisor,” says Kessler. “We’ve seen confusion from lab professionals who assume their CV or prior licensure alone is sufficient. But without third-party documentation of past experience, labs risk being cited during inspections, even in states that have their own licensure processes.
In short, your next CLIA inspection may hinge on whether your personnel files contain proper third-party documentation of experience (not just degrees or resumes). This rule applies even if your lab operates in a state that already requires personnel licensure or experience evaluation.
“Do yourself a favor and get this documentation in place now,” Kessler recommends.
What Labs Should Do Now
To stay ahead of compliance risks:
- Audit your personnel files to ensure every required staff member has third-party documentation of their experience
- Request letters or verifications now from previous employers for employees in CLIA-defined supervisory roles
- Clarify expectations with new hires and collect proper documentation as part of your onboarding process
- Consult with compliance experts if you’re unsure which staff require this documentation
At Lighthouse Lab Services, we help labs nationwide ensure their staffing and compliance records are CLIA-ready. Whether you need assistance reviewing your current documentation or securing qualified supervisors who meet the new interpretation of CLIA’s rules, our team is here to help.
Is this applicable to the employees hired prior to the new rule went into effect?
Yes, that is our understanding.
What if they were trained to be testing personnel on site through a 3-month training program in the specialty/subspecialty – and then advanced to general and technical supervisors with multiple years of experience (at the same place of employment)? How do we cover “3rd party” documentation in these situations?
Hi Jayme, thanks for reaching out for clarification on this. We’re forwarding your question to our Lab Director team and will get back soon with a response!
Here’s the response from our Director of Recruiting, Joe Kessler:
“This has been asked by several folks and the answer is that we believe employment records from their current employer (if they’ve been with them all along) should suffice – however it would be good to make sure that HR at their employer maintains a separate employment record of their job titles / job descriptions over time that could be independently corroborated by the inspector as needed. Basically, if their HR can provide attestation and it matches the technologist’s own resume or claimed experience, they should be good to go.”
is this only to validate supervisors ?or all lab testing personnel from phlebotomist, lab assistant, MLS, MLT/
This will most typically apply to leadership and management roles but can affect any CLIA-designated positions.
What is the timeframe? Example: Say someone has worked at our lab for 15 years. Do we need to get an experience verification on file for them?
Also, what if someone starts with us and they have had experience before us? Do we need to get experience verified for them?
Thank you!
Hi Kellie, in general, the answer to both questions is yes. If requested by inspectors, you will need to be able to verify experience for your existing staff, including relevant experience prior to their employment with your organization.
If you have specific examples you’d like to get an expert opinion on, we’d be happy to weigh in. Feel free to reach out to our Recruiting Team at recruiting@lighthouselabservices.com.
Thank you so much for your quick reply
I am still not 100% sure of the timeframe. If we have someone who has worked with us for 1 year, is that enough time to just need our competency docs to use for verification of experience or do we need to seek out their experience from previous employer? What is the appropriate time? Thanks so much!
I’m going to follow up with our Recruiting team since they have a better understanding of the requirements and will get back to you soon with an answer!