Preparing for a CLIA inspection—and staying prepared for future ones—is the most critical regulatory obligation your lab faces. The stress of knowing your inspection window is open, while not knowing exactly when the inspector will arrive, can be overwhelming—especially if you’re managing a high-throughput operation where there are always a few fires to put out each day.

The best way to navigate your biennial survey cycle with less stress is to create a strategic, comprehensive pre-survey checklist that’s integrated into your laboratory’s quality assurance (QA) program. By building this checklist into your daily operations (and actively working through it during your off-year), you can help your team adopt the mindset of an inspector long before one walks through the door.

At FP360, we bring deep expertise in laboratory compliance consulting to our partnerships with lab managers and their teams. In this post, we’ll walk through how to build an effective pre-survey checklist that aligns with CLIA requirements, helping you reduce risk, streamline inspection prep, and keep your lab operating at peak efficiency and compliance.

Key Elements of an Effective Pre-Survey Checklist

A strong pre-survey checklist starts with the areas your CLIA inspector will spend the most time reviewing. These core components, which reflect your lab’s compliance over the past two years, are where even small gaps can create larger regulatory risk. 

Administrative and Personnel

• Verify that your CLIA certification is current and properly displayed. 
• Ensure that all fees are paid and that certificates (COW, COC, or COA) match your testing complexity and accreditation standing.
• Confirm that personnel files are complete and include documentation of each employee’s required education and experience for their CLIA-designated role, as well as any additional qualifications tied to testing complexity and subspecialty. 
• Maintain detailed records of personnel competency evaluations, including initial training, semi-annual evaluations during year one, and annual evaluations in the following years.

Proficiency Testing and Quality

• Maintain enrollment in CMS-approved proficiency testing (PT) programs for all regulated tests. Verify that proper PT enrollment or split-sample analysis has been performed for all non-regulated tests.
• Archive all PT results, including any corrective actions taken in response to unsatisfactory or unsuccessful performance.
• Maintain comprehensive quality control (QC) logs, calibration records, and equipment maintenance documentation for all instruments and test systems.

Patient Testing Management

• Ensure written and approved procedures are in place for all phases of specimen handling (collection, labeling, transport, processing, and rejection criteria approved by the laboratory director).
• Verify that all test orders include proper documentation (written requisitions must include patient identifiers, ordering provider, test requested, and collection details).
• Confirm that test reports are complete (test, result, units, reference range, lab info) and only released to authorized individuals.
• Include a review of records retention policies, ensuring your checklist accounts for CLIA and state-specific timelines based on testing method and state regulations.

Quality Assurance (QA)

• Confirm that your laboratory layout, lighting, and workspaces meet regulatory standards for your testing complexity.
• Maintain written QA procedures that clearly define how deviations and corrective actions are handled and documented.
• Embed your new pre-survey checklist into your ongoing QA plan, reviewing it regularly to support continuous compliance and inspection readiness.

Tips for Building Your Pre-Survey Checklist

Refer to Your AO’s Resources

When building your checklist, start by checking whether your accreditation organization (AO) offers any pre-built inspection checklists or resources. 

If your laboratory holds a Certificate of Accreditation (COA), your AO likely provides electronic access to inspection criteria. These should be available from all AOs and are often written in clearer, more actionable language than the regulatory text itself (the laws on the books). These checklists are an excellent foundation, and they typically reflect both CLIA requirements and the AO’s own interpretation of best practices.

If your lab has a Certificate of Compliance (COC), you’ll need to go directly to the CLIA regulations in the Code of Federal Regulations (CFR). This means interpreting legal language yourself, so it’s especially important to cross-reference with CMS guidance and confirm you’re addressing all applicable requirements.

Check for Specialized Criteria

Once you’ve sourced the appropriate checklist, customize it to reflect all the specific attributes your laboratory may have. While the stated CFRs haven’t seen major updates since 1988, multiple AOs have created separate checklists based on extra testing your lab may be performing. 

Specialties such as LC-MS/MS, GC-MS/MS, lab-developed PCR tests, and next-generation sequencing methods are all newer, more complex technologies that have grown in our field since the CFRs were first introduced. AOs have introduced updated criteria to reflect current expectations for method validation, instrument maintenance, and quality control. 

If your lab performs any of these specialized tests, be sure your checklist incorporates the AO’s specialty-specific criteria. This will ensure your lab stays compliant while maintaining high standards for testing on a day-to-day basis.

Segment Your Checklist

Once you’ve compiled the checklist, the next step is to organize it by category. Common sections include:

• Personnel and competencies: Training records, licensure, qualifications, and ongoing competency evaluations

• Proficiency testing: Enrollment records, results, and corrective actions for all required PTs

• Instrument maintenance and calibration: Logs for routine maintenance, calibrations, service records, and equipment validations

• SOPs and documentation: Review schedules, version control, and accessibility of standard operating procedures

• Patient test management: Specimen handling, test requisition accuracy, and report integrity

• Validations: Initial and ongoing validation of new instruments, tests, or methodologies

• Quality control: Daily QC tracking, trend analysis, and documentation of corrective action

• Specialty-specific requirements: Criteria for technologies such as LC-MS/MS, PCR, or other advanced testing methods

• Facility and safety: Environmental controls, safety protocols, and physical workspace compliance

• Quality assurance: QA plan elements, monitoring systems, and integration of checklist reviews into routine operations

• Corrective actions and previous deficiencies: Documentation and follow-up on past survey findings, internal audits, and process improvements

Organizing your checklist this way makes it easier to maintain ongoing readiness and ensures your team is aligned on what to prioritize before an inspection.

Use a Table Format That Supports Action

Now that your checklist is segmented, you’ll need to format it for day-to-day usability—not just for inspection prep. A well-structured table helps your team track progress, assign ownership, and address issues proactively before an inspector finds them.

For each checklist item, include fields like:

• Requirement: What the regulation or standard calls for
• Evidence: Where and how that requirement is documented (e.g., SOP file name, system location)
• Status: Yes, No, or N/A
• Owner: Who is responsible for verifying or updating
• Follow-up: Notes on what needs to be done and by when

Use a tool that works for your lab’s workflow, whether that’s Excel, a compliance-tracking system, or your LIMS. Just make sure it’s easy to update and accessible to the relevant team members.

Tie the Checklist to Roles and Times

A checklist is only useful if it drives accountability and action. Assign each item to a responsible party and set internal deadlines for completion and review. This becomes especially important when preparing for a CLIA biennial survey or reinspection after previous findings.

How a CLIA Prep Consultant Can Help

Even experienced lab managers can benefit from an outside perspective when preparing for a regulatory inspection. A CLIA lab consultant or laboratory compliance consulting partner brings specialized knowledge of evolving requirements, industry trends, and common survey pitfalls—especially valuable for labs with complex operations.

Here are some of the capabilities the right consultant will bring to the table (or, rather, the lab bench):

Identify Gaps You May Miss Internally

Internal teams often operate with a “business as usual” mindset. A CLIA prep consultant approaches your documentation, QA systems, and staff readiness from the same angle a surveyor will. This means they’ll flag issues that might otherwise be overlooked or assumed to be “good enough.”

Run a True Mock Survey

Consultants can simulate the inspection process, walking through documentation, staff interviews, PT records, equipment logs, and previous citations. These mock inspections are invaluable in revealing compliance risks without the pressure of a formal visit. They also help staff gain confidence by practicing how to respond to inspector questions.

Accelerate Corrective Actions

If there are known issues or past citations, consultants can prioritize the work, draft or review plans of correction, and ensure that documentation meets CMS expectations. In many cases, they can also provide templates, examples, or policy language to close gaps more efficiently.

Save Time and Reduce Stress

Perhaps most importantly, a seasoned consultant helps you cut through ambiguity. Instead of interpreting every CMS line item on your own, you get clear guidance, streamlined processes, and a single point of accountability, so you and your team can focus on day-to-day operations—not second-guessing regulations.

Interested in exploring what survey prep support could look like for your lab? 

→ Reach out to FP360 today for tailored laboratory compliance consulting solutions.