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CLIA

 Clinical Laboratory Improvement Amendments
(CLIA)

Any facility performing laboratory testing in the state of Montana is subject to the federal regulations of the Clinical Laboratory Improvement Amendments
(CLIA).

A laboratory is defined by CMS as a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings.

Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.

 

CLIA FAQ

CLIA Application

CLIA Application

 

Complete a CLIA application in its entirety for the following:

  • Change in Certification Type
  • Change in Laboratory Director

Completed application can be returned to the Montana CLIA Program via scan/email, fax or mail. Incomplete applications cannot be processed.

The following changes do not require a CMS-116 form to be filled out but can be changed by notifying the Montana CLIA program in writing (email, fax, or mail). Please include your CLIA number and the current information, as well as the new information.

  • Change of physical address
  • Change of mailing address
  • Change of telephone number
  • Change of fax number
  • Change of name of facility

Certificate of Waiver

Certificate of Waiver Information

 

This information is specific to the State of Montana Certificates of Waiver. For information about other state CLIA programs, please contact the local state agency.

Certificate of Waiver FAQ

 

Basic Regulations

  1. Perform only waived tests
  2. Follow all of the manufacturer's instructions completely
  3. Maintain your CLIA certificate: pay the bill, notify the Montana CLIA program, in writing, of any changes (name, address, Lab Director, or non-waived testing)
  4. Allow the State Surveyor to visit, if necessary

To Test of Not to Test Booklet

Ready Set Test Booklet

Certificate of Waiver Self-Assessment Checklist

 

Certificate of Provider Performed Microscopy Procedures (PPMP)

Certificate of Provider Performed Microscopy Procedures (PPMP)

 

This information is specific to the State of Montana Certificate of PPMP. For more information about other state CLIA programs, please contact the local state agency.

Certificate of Provider Performed Microscopy Procedures FAQ

Basic Regulations

  1. Perform only PPM and waived tests
  2. Compliance with PPM moderate complexity regulations and follow manufacturer directions for waived tests
  3.  Maintain your CLIA certificate: pay your bill, notify the Montana CLIA program, in writing, of any changes (name, address, Lab Director, non-PPM testing)
  4.  Allow the State Surveyor to visit, if necessary

List of PPMP Tests

PPMP Booklet - A Focus on Quality Practices

 

Survey Forms

Survey Forms

 

Please fill out the following forms prior to your scheduled survey and give them to the surveyor upon arrival.

CMS-116

CMS-209

Test Volume Worksheet

Information and Resources