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 or Not to Test Booklet

Ready Set Test Booklet

Certificate of Waiver Self-Assessment Checklist

 

Certificate of Provider Performed Microscopy Procedures (PPMP)

Guidelines for Certificate of Provider-Performed Microscopy Procedures (PPMP)

A Certificate of Provider-Performed Microscopy Procedures (PPMP) permits a laboratory to perform a limited list of moderate complexity tests, as well as any waived tests.

Surveys are not required but may be conducted and compliance with CLIA regulations is mandatory. The following criteria must be met:

  1. The laboratory must obtain a CLIA certificate and pay the biennial fee which authorizes the facility to perform only waived and PPMP tests for a period not to exceed two years.
    1. CLIA Certificate Fee Schedule
  2. The PPMP procedures must be personally performed by one of the following practitioners (42 CFR §493.1363):
    1. A physician during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or an employee.
    2. A midlevel practitioner, under the supervision of a physician or in independent practice authorized by the State, during the patient's visit on a specimen obtained from his or her own patient or from a patient of a clinic, group medical practice, or other health care provider of which the practitioner is a member or an employee.
    3. A dentist during the patient's visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee.
    4. All must have a Montana State License.
  3. The laboratory director (42 CFR § 493.1357) must have an individual state license and meet one of the following requirements:
    1. Be a physician
    2. Be a midlevel practitioner
    3. Be a dentist
  4. The PPMP procedures are categorized as moderately complex.
  5. The primary instrument for performing the PPM procedures is a microscope, limited to a bright field or phase-contrast microscopy.
  6. The PPMP specimens are labile and a delay in performing the test could compromise the accuracy of the test result.
  7. Control materials are not available to monitor the entire testing process; but two levels of controls must be performed if available.
  8. Limited specimen handling or processing is required.
  9. The physician, midlevel practitioner or dentist may perform one or more of the following procedures listed on CMS website in additions to any test classified as waived.
    1. List of PPMP Tests
    2. FDA Product Classification
  10. The laboratory must verify the accuracy of PPMP test results at least twice a year.
  11. The laboratory must meet all the applicable requirements of participation in proficiency testing, patient test management, quality control and quality assurance.
  12. For more information refer toPPMP Booklet - A Focus on Quality Practices

-- For waived testing, the laboratory must follow the manufacturer’s instructions. --

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