Clinical Laboratory Improvement Amendments
(CLIA)

Laboratory Changes that Require Submitting a New Form CMS-116

A new Form CMS-116 MUST be obtained when any of the following laboratory changes takes place:

• Initial Application
  • When applying for the temporary testing site exception, a list of the temporary testing sites must be included on or attached to the Form CMS-116 (page 2).

    Multiple sites are permitted to operate under a single certificate when the sites meet one of the multiple site exceptions at 42 CFR §§ 493.35(b), 493.43(b), or 493.55(b). Each site performing testing under a single certificate must meet all applicable requirements of 42 CFR Part 493.

    Please refer to CMS State Operations Manual Chapter 6 - Special Procedures for Laboratories; 6010 - Regulatory Exceptions for a Multiple Site Certificate, to determine if your facility is eligible for an exception. (Link):  Medicare State Operations Manual

• Survey, Initial or Recertification
• Certificate Type Change
• Reinstatement of CLIA certificate
• Adding a multiple site exception, including temporary testing sites, to an existing CLIA certificate
  • >A list of temporary testing sites must be included on or attached to the Form CMS-116.

• Director Change (Provider-Performed Microscopy (PPM) Certificate or Certificate of Compliance)
  • Laboratory directors performing non-waived > testing (including PPM) must meet specific education, training, and experience under subpart M of the CLIA regulations. Proof of these qualifications for the laboratory director must be submitted with this application.

• Ownership

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

Laboratory Changes for which Written Notification (at minimum) is Acceptable

At a minimum, written notification must be obtained when any of the following laboratory changes take place:

• Name of the Laboratory
• Location (Physical location)
• Location (Mailing Address)
• Tax ID (EIN)
• Specialty or Subspecialty Change
• Total Test Volume Change
• Telephone and Fax Numbers
• Email Address and requests to receive future notifications via email

• Voluntary Closure/Termination
• Personnel-Technical Supervisor

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 wet signature or certified electronic signature of the Laboratory Director.

Please Note: Certificate of Accreditation (CoA) laboratories change to PPM procedures ONLY, the laboratory must downgrade its certificate to a Certificate for PPM procedures. It may not continue to hold a CoA. The same policy applies to laboratories that perform only waived testing that are operating under a CoA and decide to only perform waived testing. The laboratory must update their certificate to a Certificate of Waiver.

Please email new CMS 116 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.

File Transfer Service

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

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 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

Please refer to the CDC.gov website for educational material for waived testing. Waived Tests | Laboratory Quality | CDC.

To Test or Not to Test Booklet

Ready? Set? Test! Booklet

Certificate of Waiver Self-Assessment Checklist

Ready? Set? Test! Patient Testing Is Important. Get the Right Results. | OneLab REACH

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. Laboratories of Performing Provider-Performed Microscopy (PPM) Procedures are required to follow the regulations found at the following URL: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#subject-group-ECFR9fd4b51b2991285).

   Laboratory Director

   • 493.1357 Standard; laboratory director qualifications.

   . § 493.1359 Standard; PPM laboratory director responsibilities. 

   Testing Personnel

   • 493.1363 Standard: PPM testing personnel qualifications.
   • 493.1365 Standard; PPM testing personnel responsibilities.

3. Additional educational information can be found at the following links:

   Provider-Performed Microscopy Procedures | Laboratory Quality | CDC

   Provider-Performed Microscopy Procedures: A Focus on Quality Practices

   CLIA and PPM Procedures: An Introduction eLearning course

   List of PPMP Tests

   FDA Product Classification

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. --

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:  

• Form CMS-116
• Form CMS-209
• Test Volume Worksheet

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

CMS CLIA Homepage

FDA CLIA Test Complexity Search

CLIA Laboratories Demographic Lookup

Survey and Certification Memos

Board of Clinical Laboratory Science Practitioners Website

State of Montana Public Health Lab

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