CLIA Survey Packet

All facilities that hold a Certificate of Compliance in the state of Louisiana are subject to on-site inspections conducted by the Louisiana Department of Health, Health Standards Section CLIA Program surveyors.  Off cycle surveys for addition of specialties, PT Desk Review, Complaints and Validation survey of accredited laboratories may also be surveyed by this agency. This Survey Information Packet will provide you with the information you need to prepare for your upcoming survey.

Surveys are generally announced; however, CMS does not allow more than a two week notification of the survey.  You will be contacted with the exact survey date of your survey by the specific inspector. 

We encourage you and your staff to familiarize yourselves with Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services.  This document will outline the CLIA survey process. 

In order to facilitate the survey process we request that you complete and sign the following forms: 

1. Disclosure of Ownership Form
2. Form CMS-209 (Personnel) – sign and date the original 209 and use the photocopy to list your personnel. 
3. TASK 1&3 Form - Compile a list of tests and specialties performed in the laboratory.  Also include the annual test volume (test count) for each test listed. 
4. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION - Complete the Application with the current information for your laboratory.  

Complete and maintain these forms onsite until the time of survey unless the surveyor for your laboratory requests them to be returned ahead of time. 

Additionally, on the date of survey you should be able to produce the following materials/information as specified by CLIA regulations at Section 493.1777( c ): 

1. Laboratory policies and procedures 
2. Test procedures manual
3. Procedures for all test performed
4. New procedures
5. Package inserts
6. Client manual (where applicable) 
7. Laboratory accession log (daily patient testing log or a listing of test procedures by patient, performed on a daily basis)
8. Personnel records including training documents, certificates, degrees, CE, verification of education, primary source verification (PSV), documentation of experience and employee evaluations. 
9. Quality control records including remedial action information 
10. Proficiency testing (PT)  records to include:  evaluation reports; test records which document the manner in which PT material was handled including direct instrument printouts, test logs, etc.; and copies of PT report forms which document PT results and the signed attestation statement.
11. Safety information
12. Instrument maintenance records and repair information 
13. Quality assessment (QA) plan and documentation of the monitoring and evaluation processes conducted.
14. Personnel duties/responsibilities/changes (i.e. Director approved job descriptions)

Contact

For more info, contact Alexa Little at (225) 342-9324 or email HSS-CLIA-SurveyPacket@la.gov.