Clinical Laboratory Improvement Amendments
(CLIA)

Who Needs a CLIA Certificate?

Any facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. If a facility performs tests for these purposes, regardless of whether there is reimbursement for such tests, it is considered to be a laboratory according to the definition by CLIA and must obtain and maintain CLIA certification.

Tests for which a CLIA certificate IS NOT required include:

  • forensic testing
  • blood draws
  • specimen collections
  • drug testing for purposes of employment

Basically, if you do not perform any testing on-site you do not need a CLIA certificate. However, CMS allows for certain exceptions to this rule, such as mobile units, home health agencies with multiple branches and temporary testing sites. In these cases, a separate certificate is not issued to each testing location but to a designated primary site, parent location or home base.

For more information about Who Needs a CLIA Certificate: Code of Federal Regulations (govinfo.gov)

CLIA FAQ

 

CLIA Application

CLIA Application

Please email new applications or changes to either MTSSAD@mt.gov or Michelle.Griffin@mt.gov

To send information that is HIPPA protected or too large for the State email system, use the State File Transfer Service to securely send documents. It is a free service.

New CLIA Certificate applications or changes to current CLIA Certificates

A new Form CMS-116 must be obtained when any of the following laboratory changes or events take place:

  • Initial Application
  • Survey, Initial or Recertification
  • Certificate Status Change other than to a Certificate of Waiver
  • Reinstatement of CLIA Certificate with a Gap in Certification
  • Laboratory Director Change (Provider-performed Microscopy (PPM); Certificate of Compliance)

Help with a new CLIA Certificate Application:  Laboratory Quick Start Guide CMS CLIA Certificate  

For other changes a written notification (email or hard copy) or a new CMS-116 is acceptable.

  • Certificate Status change to Certificate of Waiver
  • Name of Laboratory
  • Location (Physical Location), (Mailing Address), (Corporate Address)
  • Ownership
  • Tax ID (EIN)
  • Specialty or Subspecialty change (Certificate of Compliance)
  • Telephone and Fax Numbers
  • Reinstatement - Activate without a Gap
  • Multiple Site
  • Change in Accreditation Organization
  • Voluntary Closure/Termination

The written notification must include the laboratory’s name, CLIA number, the name of Laboratory Director and Owner, description of the change(s) being made, and the signature of the Laboratory Director.

Additional Information : Clinical Laboratory Improvement Amendments (CLIA) | CMS
 

Multiple Sites

A laboratory may request multiple site laboratory status if it meets any one of the following three exceptions:

  1. Laboratories that are not at a fixed location, i.e., laboratories that move from testing site to testing site, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations may be covered under the CLIA certificate and address of the designated primary site or home base, using its address.
  2. Not-for-profit or Federal, State, or local government laboratories that engage in limited (not more than a combination of 15 types of moderately complex or waived tests per certificate) public health testing may file a single application. Laboratories that perform high complexity testing are not eligible for this exception.
  3. Laboratories within a hospital that are located at contiguous buildings or on the same campus or same physical location or street address and under common direction may file a single application or multiple applications for CLIA certificate(s) for the laboratory sites within that hospital.

Facilities who believe they qualify for ‘Multiple Site’ status must submit their request using the CLIA Application for Certification, Form CMS-116. On page 2 of the application, the laboratory should check “Yes” for the multiple site exception and indicate which exception applies to their situation (Exception 1, 2, or 3). The laboratory should fill out the bottom section of page 2 indicating the name, address, and telephone number of each location and the tests performed. If additional space is needed, a separate sheet can be attached.

Two Certificates at One Location

Two labs may operate at the same location with separate CLIA certificates as long as both labs comply with the following conditions:

  • The times for laboratory testing must be shown for each laboratory’s operation and must not overlap;
  • Each lab must have a unique name;
  • The testing personnel must not perform testing for both labs at the same time;
  • Each laboratory must maintain entirely separate records and demonstrate independent operation; and
  • It is recommended that each lab enroll in separate PT programs to prevent PT Referral.

The laboratories can share the same Laboratory Director as long as the director does not violate the 5 non-waived laboratory rule.
 

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 Information

All Montana facilities that hold a Certificate of Compliance are subject to on-site inspections. 

The following required forms are to be filled out prior to your scheduled survey:  

During the Survey

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 or IQCP (Individual Quality Control Plan) documents and records.   (More information on IQCP

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 typed directly into the form provided. 

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.

Information and Resources