What Updated CMS CLIA Guidance Means for Verifying Laboratory Personnel Qualifications

Updated interpretive guidelines in the CMS State Operations Manual Appendix C, outlined in QSO-25-10-CLIA, provide additional guidance related to laboratory personnel requirements under 42 CFR Part 493. For laboratory leaders, the guidance clarifies expectations for documentation used to support personnel education, training, and experience — including that a curriculum vitae or résumé, by itself, is not sufficient verification.

For laboratory leaders, managing personnel qualifications requires more than confirming that a degree, license, certification, or other credential exists. The greater challenge is maintaining a complete and current record that shows what has been verified, what remains outstanding, and whether the documentation on file is adequate to support compliance. A structured qualification process gives leaders clearer visibility across the workforce, helps surface gaps before they become issues, and makes it easier to produce defensible documentation when surveyors request evidence.

Many laboratories manage these activities across email, spreadsheets, shared drives, and separate personnel records. The documentation may exist, but reconstructing the request, source, review decision, and outcome can require unnecessary effort.

A structured Primary Source Verification workflow brings those steps together, giving teams a clearer view of what has been requested, what is still outstanding, what has been received, and how each verification was resolved. Bringing that process directly into the MediaLab by Vastian Personnel Documentation app can reduce manual tracking, simplify follow-up, and make the day-to-day management of personnel qualifications far easier.

What Is Primary Source Verification?

Primary Source Verification, or PSV, is the process of confirming an individual’s credentials or reported work history with the institution, former employer, licensing organization, certification body, or authorized agent responsible for the information. PSV isn’t required for every qualification, but it’s a strong way to meet the new CMS documentation expectations and create a clear record of verification.

Depending on the qualification being reviewed, verification may include:

• Degrees, diplomas, or educational transcripts
• Licenses and certifications
• Training records completed through an external organization
• Previous employment or work experience
• Other credentials relevant to a CLIA personnel qualification

The updated CMS CLIA interpretive guidance is particularly important for qualifications that depend on education, training, or experience. CMS states that supporting documentation must be generated by someone other than the individual attempting to meet the personnel qualification requirement. A CV or résumé alone is therefore not sufficient evidence of the claimed education, training, or experience.

CMS also provides examples of acceptable documentation, including employer/training-program letters, laboratory-director attestations of training and experience, training logs, certificates, competency assessments, and comprehensive descriptions of job responsibilities.

Two Priorities for Laboratory Leaders

A well-defined verification process helps laboratories strengthen both compliance documentation and day-to-day oversight.

Strengthen Compliance Documentation

Laboratory leaders need clear, reliable evidence that personnel meet applicable CLIA qualification requirements. This is especially important when qualifications depend on prior experience or training, where a CV or résumé alone may not provide sufficient support.

Laboratories can substantiate these requirements using documentation from previous employers, training programs, qualified individuals, primary source verification, or a combination of appropriate sources. Maintaining this evidence in a consistent and accessible way helps create a more complete personnel record and makes it easier to respond when documentation is requested during an inspection or survey.

Improve Visibility and Follow-Up

Verification becomes harder to manage when requests, due dates, supporting documents, and status updates are tracked in different places. A centralized workflow gives laboratory administrators a clearer view of what requires attention, what has been completed, and what remains outstanding.

Within MediaLab, documents designated as Verification Required are surfaced in a dedicated queue, allowing administrators to focus on the verification activities they have chosen to manage. This reduces reliance on separate spreadsheets and manual tracking

while providing better visibility into pending requests, due dates, and supporting documentation.

A Centralized Approach to Primary Source Verification

To support this work, MediaLab has introduced a Primary Source Verification Management Center within Personnel Documentation. The new workspace gives laboratories a centralized way to manage verification requirements, track external requests, retain supporting documentation, and maintain a clear history of review activity within the personnel record.

Define What Requires Verification

Administrators can designate documentation types as requiring verification and establish due dates for completion. This allows the laboratory to configure its workflow based on its own personnel qualification requirements, policies, and verification practices.

Manage Requests From One Workspace

The Primary Source Verification Management Center brings documentation assignments eligible for verification and outgoing requests into one workspace. Administrators can select the employee and documentation requiring verification, identify the external organization responsible for providing verification, and initiate the request without maintaining a separate tracking process.

Create Consistent, Reviewable Outreach

Preconfigured request messages and dynamic placeholders populate employee, recipient, site, and documentation details, reducing repetitive data entry. Administrators can customize and review the completed request before it is sent to the external organization.

Give External Verifiers a Secure Submission Process

External recipients do not need MediaLab credentials. A secure link and one-time email verification code provide access to a portal where recipients can review the request, upload supporting documentation, or indicate that they are unable to verify the requested qualification.

This provides a controlled path for collecting supporting documentation directly from the external source.

Maintain Visibility From Request Through Completion

Administrators can monitor request progress, resend requests, update statuses, and review the complete Request History. This creates a traceable record from the initial outreach through document submission, review, and completion.

Connect Verification Documentation to the Personnel Record

Administrators can review submitted files, determine whether the information adequately supports the applicable personnel qualification, and retain the review outcome with the employee’s personnel record. Confirmed records appear in a dedicated Primary Source Verification section of the employee’s Personnel Documentation Report, creating a connected history of the request, supporting documentation, and review decision.

Purpose-Built for Laboratory Quality Management

General business tools can store emails and files, but they were not designed around laboratory personnel qualification workflows.

MediaLab brings Primary Source Verification management directly into a QMS purpose-built for laboratories, giving lab teams a verification workflow designed around their specific personnel, compliance, and documentation requirements. Rather than adding another standalone process, laboratories can manage verification requirements, due dates, requests, supporting records, status information, and completion history within Personnel Documentation.

As CLIA expectations around personnel qualification documentation continue to evolve, laboratories using MediaLab have an integrated way to manage verification activities and maintain the supporting evidence within the personnel record.

A More Structured Path Forward

The updated CLIA guidance reinforces the need for laboratory leaders to assess whether personnel qualification records are adequately supported, particularly when prior experience or training is used to satisfy a CLIA requirement.

A CV or résumé can help identify an employee's experience, but it should not stand alone as the documentation establishing that experience. Laboratories should maintain supporting evidence generated by someone other than the individual whose qualifications are being evaluated.

A structured Primary Source Verification process keeps those steps connected. It gives administrators greater visibility into requirements, due dates, outstanding requests, submitted documentation, and review outcomes while supporting CLIA compliance as an ongoing practice.

Learn how Personnel Documentation brings verification requirements, secure requests, supporting records, and review history into one laboratory-focused workflow.

Explore Primary Source Verification Management in Personnel Documentation.