The Survey Process

The primary objective of the survey process is to determine whether or not a laboratory meets CLIA requirements. Although CMS reserves the right to inspect any laboratory issued a CLIA certificate, regardless of certificate type, the majority of Waived and PPM labs are not subject to routine on-site surveys.

Surveys are required for all Certificate of Accreditation laboratories. The survey is conducted by inspectors from the Accrediting Organization. CLIA surveyors annually perform validation surveys on a certain number of accredited laboratories based on the numbers included in the CMS annual budget. Facilities should consult with their Accrediting Organization with any questions regarding inspections.

When Surveys are Conducted

Surveys are condcuted using the following time frame:

All facilities that hold a Certificate of Compliance in the State of Tennessee are subject to on-site inspections conducted by Tennessee Department of Health State Agency surveyors. The rest of this section will describe the survey process for laboratories with certificates of compliance

Preparing for Your CLIA Survey

Before the Survey: The Pre-Survey Packet

A pre-survey packet is available under the Forms and Resources tab but can also be sent upon request to the facility via fax, email, or regular mail. The packet includes the following forms:

1. CMS-209 Laboratory Personnel Report Form Use this form to list all laboratory personnel by their position within the laboratory setting.
2. CLIA Laboratory Specialties Test Volumes Form Use this form to list all non-waived tests performed in the laboratory. Tests sent out to a reference laboratory should not be included.
3. Disclosure of Ownership and Control Interest Statement- TN
4. CLIA application form, CMS-116

All forms should be completed and signed prior to the survey date.

During the Survey

In addition to the forms above, the following documents/materials should be ready and retrievable on the date of the survey:

1. Laboratory policies and procedures, including package inserts, new and discontinued test procedures, and operator’s manual.
2. Laboratory Personnel records, including training documents, certificates, degrees, CE, verification of education, documentation of experience, employee evaluations and annual competency assessments, diplomas or transcripts from the highest education degree earned, current license(s), orientation/training for new laboratory personnel, in-service and continuing education, and job duties/responsibilities.
3. Proficiency testing (PT) records, including evaluation reports, instrument printouts, test logs, submission forms, attestation sheets, scores, and corrective actions.
4. Quality control records, including control results, daily, monthly and cumulative summaries and Levy-Jennings charts, calibrations and calibration verifications, and corrective action for unacceptable control and calibration results.
5. Safety manuals, information and records
6. Instrument and equipment maintenance and function check records, including routine daily, weekly, monthly, etc. maintenance; service and repair information; electronic and function checks, and equipment and reagent monitoring.
7. Quality Assessment/Assurance (QA) Plan and records
8. IQCP (Individual Quality Control Plan) documents, if applicable.

The survey process includes observation of facilities and processes, interviews, and record review. The surveyor may ask to view various records and documents so be prepared to retrieve what is asked for. CLIA regulations give the surveyor the authority to look at all documents necessary to assess compliance.

The primary goal of the survey is to assess the laboratory’s performance, determine compliance with the regulations and ensure the quality of patient testing. If a problem is revealed during the survey, the nature and seriousness of the problem is determined and whether a negative or potentially negative outcome exists.

At the end of the survey an exit conference is conducted. Its purpose is to review findings with the laboratory. It offers the laboratory the opportunity to present additional information in response to the findings. If deficiencies are found, the surveyor will provide instructions and a timeframe for submitting an appropriate plan of correction. This would be a good time to ask questions and receive clarification from the surveyor if you are unclear on anything found during the survey.

After the Survey

If any deficiencies are identified the lab will be required to take corrective action to fix them. The surveyor will send a Statement of Deficiencies, CMS-2567, for the lab to outline the steps needed to correct the deficiencies. The plan of correction must be written (in ink) or typed directly on the form provided. The plan of correction must include:

1. A step-by-step description of the method(s) used to correct the problem(s) which caused the deficiencies. The plan of correction must provide information that assures the intent of the regulation is corrected. Simply stating that the problem was corrected is not acceptable. Specific details must be included.
2. State the method(s) to be used to maintain and monitor compliance. Indicate the staff position(s) responsible for monitoring the correction to prevent the deficiency’s re-occurrence. State your anticipated frequency of monitoring.
3. A realistic date of correction by month, date and year.
4. The plan of correction must be signed and dated by a representative of your laboratory.
5. Instructions on how to complete an acceptable plan of correction can be found here.

For any deficiency, a revisit or follow-up is conducted. The timeframe depends on the type of deficiency and severity. For condition-level, evidence of compliance must be received or noted within 45 days of the survey. For standard-level, compliance must be met within 12 months of the survey. If immediate jeopardy was identified during the survey, compliance must be met within 23 days to avoid the enforcement process. For more details about the CLIA survey process, see CMS’s Interpretative Guidelines for Laboratories.