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Louisiana Department of Health & Hospitals | Kathy Kliebert, Secretary

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Statewide Initiatives



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Laboratory Director Qualifications

 

Certificate of Waiver

 

There are no personnel requirements for a Certificate of Waiver.  The laboratory can designate any individual from their facility to be the Laboratory Director who is responsible for the oversight of waived testing.  Therefore, there is no additional documentation required to be submitted for this individual.

 

Certificate of Provider Performed Microscopy Procedures (PPM)

 

The Laboratory Director for PPM testing must be a physician, midlevel practitioner or dentist licensed in the state of Louisiana.  If applying for initial certification or changing the Laboratory Director of a Certification of PPM, you must submit documentation of the qualifications of the individual.  Information to be submitted with the application or request for change includes:

 

·         A copy of the current Louisiana state license**

·         A copy of the diploma or transcripts from an accredited institution

·         A copy of an equivalency evaluation of education on individuals who attended foreign schools

 

Certificate of Compliance and Certificate of Accreditation

 

The qualifications of the Laboratory Director for a Certificate of Compliance or a Certificate of Accreditation will be different for moderate complexity testing versus high complexity testing. 

 

For moderate complexity testing the laboratory must have a Laboratory Director who meets the qualification requirements of §493.1405.

 

For high complexity testing the laboratory must have a Laboratory Director who meets the qualification requirements of §493.1443.

 

If applying for initial certification or changing the Laboratory Director of a Certification of Compliance, you must submit documentation of the qualifications of the individual.  Only upon initial application for a Certificate of Accreditation must the qualifications of the laboratory director be provided to CLIA.  Information to be submitted with the application or request for change includes:

 

·         A copy of the current Louisiana state license**

·         A copy of the diploma or transcripts from an accredited institution

·         A copy of an equivalency evaluation of education on individuals who attended foreign schools

·         A copy of credentials (i.e. board certification from CMS approved boards)

·         Documentation of Laboratory Experience

 

**CMS does not accept a copy of an on-line verification of state license.  A copy of the actual license MUST be submitted.