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What's New and Important

CLIA completed its transition to a paperless system. CMS no longer mails CLIA certificates or paper fee coupons. Additionally, all CLIA certification and survey fees must be paid online (payments by paper check are no longer accepted).

If you've already made the switch to paperless, we thank you. No further action is required.

Laboratories must have a valid email address on file to get electronic CLIA certificates, fee coupons, and other CMS communications. Without a valid email address, you may experience billing or certification issues.

Missed the Deadline? Here's What to Do

  • Email written notification to LARA-BSC-CLIA@michigan.gov. Include:
    • CLIA number
    • Laboratory name
    • Laboratory address
    • Laboratory director or owner's name
    • Email address to receive notifications
    • Laboratory director or designee's signature

Payments must be online at Pay.gov. Instructions to guide you through the process can be found HERE. 

About CLIA

What is CLIA?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) is a federal program under the jurisdiction of the Centers for Medicare and Medicaid Services (CMS). The CLIA amendments established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.

On behalf of CMS, the Bureau of Survey and Certification (BSC) serves as the Michigan State Agency (SA) for federally certified programs participating with Medicare. Within BSC, the Laboratory Improvement Section manages the CLIA program and administers the certification of clinical laboratories in accordance with CLIA regulations.

CLIA program duties/activities include performing onsite inspections (referred to as surveys by CMS), ensuring accuracy and reliability of laboratory testing via proficiency testing review, investigating complaints, and monitoring approximately 10,000 clinical laboratories in Michigan.

The CLIA program is regulated for compliance under guidelines set forth in Federal Regulations 42 CFR Parts §493.1 through §493.1850.

Who needs a CLIA Certificate?

Any facility or provider that performs laboratory tests on human specimens for the purpose of diagnosis or for the treatment of disease is required by federal law to have a CLIA certificate. A CLIA certificate is required regardless of reimbursement and there is no minimum test volume. Plainly stated, a CLIA certificate must be obtained if only one test is performed, even if payment is not received.

A CLIA certificate IS NOT required for:

  • Blood draws
  • Specimen collections
  • Pre-employment drug and alcohol testing
  • Court ordered drug and alcohol testing
  • Breath alcohol testing
  • Forensic Testing
  • TB Skin Testing

Certificate Types

Certificate of Waiver

A Certificate of Waiver allows a facility to perform only tests that are categorized as waived by the Food and Drug Administration (FDA). As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring. The FDA maintains an online database of FDA approved laboratory testing and their respective categorization at the following link: FDA CLIA database

The main requirements for facilities performing waived testing are to follow the manufacturer’s instructions and to have a current CLIA certificate. There are no qualification requirements for the laboratory director or testing personnel of facilities/providers with a Certificate of Waiver.

A Certificate of Waiver also allows a facility to perform testing granted Emergency Use Authorization (EUA) by the FDA for use in a waived setting. EUA is usually associated with COVID-19 testing. The FDA maintains an online database of all testing granted EUA at the following link: In Vitro Diagnostics EUAs | FDA

Certificate for Provider Performed Microscopy Procedures (PPM)

The Certificate for Provider Performed Microscopy Procedures (PPM) is issued to facilities/providers that perform a limited list of tests requiring a microscope. A laboratory with this certificate may perform all CLIA waived tests and nine approved microscopic procedures. PPM tests are considered moderately complex; therefore, the facility must comply with CLIA regulations for moderate complexity testing. The nine approved microscopic procedures are listed on the CMS 116 application in Section VII. PPM Testing.

The director of a PPM laboratory must be a state licensed physician, mid-level practitioner, or dentist. When applying for a PPM certificate, the facility must provide a copy of the director’s current MI medical license, nursing license or dental license.

Certificate of Registration

The Certificate of Registration is initially issued to a laboratory that has applied for a Certificate of Compliance or a Certificate of Accreditation. This certificate permits the laboratory to perform moderate and high complexity laboratory testing until the survey is performed, and the laboratory is found in compliance with the CLIA regulations.

Surveys for Certificate of Registration laboratories are generally conducted between 90 days and twelve months after the effective date of the certificate. Once the survey has been completed and the facility is found in compliance, the facility will receive a user fee coupon to obtain a Certificate of Compliance or a Certificate of Accreditation.

In addition to moderate and/or high complexity testing, a facility issued a Certificate of Registration can also perform PPM and waived testing.

Certificate of Compliance

A Certificate of Compliance allows a facility to conduct moderate and/or high complexity testing. This certificate is issued to a laboratory after a survey has been conducted, and the facility is found in compliance with all applicable CLIA requirements.

Surveys for Certificate of Compliance laboratories are conducted by Michigan Department of Licensing and Regulatory Affairs laboratory evaluation specialists. Surveys for recertification of laboratories are conducted 6 – 12 months prior to the expiration date of the certificate.

The laboratory director of a Certificate of Compliance laboratory must be qualified to oversee non-waived testing. When applying for a Compliance certificate, or when changing the laboratory director, the facility must also submit documentation of the director’s qualifications.

In addition to moderate and high complexity testing, a facility that is issued a Certificate of Compliance can perform PPM and waived testing.

Certificate of Accreditation

A Certificate of Accreditation allows a facility to conduct moderate and/or high complexity testing. This certificate is issued to a laboratory after a survey has been conducted, and the facility is found in compliance with all condition level CLIA requirements and Accrediting Organizations (AO) standards.

Surveys for Certificate of Accreditation laboratories are conducted by inspectors from the accreditation organizations.

The director of a facility with a Certificate of Accreditation must be qualified to oversee non-waived testing. When applying for an Accreditation Certificate, or when changing the laboratory director, the facility must also submit documentation of the director’s qualifications. Also, during the initial application process, the facility must select a specific Accreditation Organization (AO) on the CLIA application and provide evidence of enrollment with the organization.

In addition to moderate and high complexity testing, a facility that is issued a Certificate of Accreditation can perform PPM and waived testing.

Application Process

  • How to Apply

    Complete all sections of the CMS 116 CLIA Application. All requested information must be completed in Section I. General Information. The CLIA Identification Number space will be blank if one has yet to be assigned. The primary means of communication with Michigan CLIA State Agency will be via email. At this time, only one email address may be entered into the CMS database. Please provide an email address that will be monitored regularly. The instruction pages of the application (pages 6-10) DO NOT need to be submitted with the application.

    Provider Performed Microscopy Certificate, Certificate of Compliance, and Certificate of Accreditation require additional documentation be submitted with the completed CMS 116 application. See Providing Additional Documentation.

    The following link may assist with completing the CMS 116 application: Quick Start Guide

  • Providing Additional Documentation

    Laboratory Director Qualification.  CLIA regulations specify qualifications for laboratory directors to oversee unwaived testing. The documentation necessary for director qualification varies based on the complexity level of the testing (moderate or high) as well as the individual's educational background and professional experience.

    Provider Performed Microscopy Laboratory Director Qualification Requirements: 
    https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1357

    Moderate Complexity Laboratory Director Qualification Requirements: 
    https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1405

    High Complexity Laboratory Director Qualification Requirements: 
    https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.1443

    Documentation to submit

    • A copy of the State of Michigan license.
      • Do not submit screenshots or printed versions of the LARA Find/Verify a License webpage. It must be a copy of the license.
    • A copy of board certifications, if applicable.
      • A list of acceptable courses from CMS can be viewed here
    •  Documentation of experience and/or training, if applicable.
    • Additional documentation may be required based on the individual.

    Documentation of Experience and/or Training

    • Types of laboratories providing applicable experience:
      • The director, supervisory, training, or testing experience must be obtained in a laboratory. The laboratory must be a facility that tests 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 the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body.
    • Type of experience required:
      • The type of experience required must be clinical in nature and experience in research or in forensic laboratories would not be acceptable.
      • The laboratory director should have documentation, e.g., signed procedure manuals, test reports, and worksheets, indicating that the director assumes their regulatory responsibilities.
      • Teaching experience directly related to a medical technology, medical laboratory science, clinical laboratory sciences program, or a clinical laboratory section of a residency program, would be considered acceptable experience.
    • Documentation may consist of, but is not limited to, the following:
      • Letters from training programs or employers. These must include an official letterhead.
      • Attestation statements of an individual's training and experience by the laboratory director.
      • Log sheet(s) initialed by the individual indicating attendance at a training session or in-service.
      • Certificates from organizations providing training sessions, workshops, conferences, and specialty courses.
      • Documentation supporting an individual's education, training, and experience must not be generated by the individual.
    • A Curriculum Vitae (CV) is not acceptable verification, in and of itself, to document an individual's education, training or experience.

     

    Accreditation Enrollment Applicants for a Certificate of Accreditation should provide evidence of enrollment with one of the CMS approved accreditation organizations. If a laboratory has not yet enrolled with one of these organizations upon submission of their application to CLIA, then they must provide evidence of application for accreditation with an accrediting organization within eleven months after receipt of the Certificate of Registration.


  • Submitting Your Application

    A complete application* may be emailed to LARA-BSC-CLIA@michigan.gov.  All documentation regarding director qualifications and/or accreditation enrollment should be included. All attachments should be in pdf format. *Only pages 1-5 of the CMS 116 application should be submitted. The instructions (pages 6-10) should not be included.

    Applications may also be submitted via fax. Faxed applications should have “Attn CLIA” noted on the cover sheet and can be sent to (517) 763-0214.

  • What Happens Next?

    Applications are processed into the Centers for Medicare & Medicaid Services (CMS) CLIA system. Congratulations! The physical address noted on the application is now officially a laboratory in the State of Michigan. After the application has been processed, a confirmation letter with the assigned CLIA number will be emailed.

    CMS will email a fee coupon in 1-2 weeks, see Fees and Payments section for more details. Fees must be paid to receive a certificate.

    How Will I Receive My Certificate?

    CLIA certificates are emailed to the email address provided on the application. Emails for certificates (and fee coupons) will come from: noreply-cms-ccsq@ccsq.cms.hhs.gov. This is an official CMS address, no spam. To ensure you receive these important communications, adjust your email settings or spam filters so messages from this address are delivered directly to your inbox.

    DO NOT SEND PAYMENT TO THE STATE OF MICHIGAN

    The CLIA account will be activated when payment processing has finalized. The lab's CLIA certificate will be generated and emailed to the contract email address provided on the 116 application.
    Certificates are not immediately available after paying fees online. It will take 1-2 weeks for the laboratory to have access to the electronic certificate.

Fees and Payments

CLIA Fees

CMS will automatically generate a fee coupon when initial applications are processed and when an existing certificate is due for renewal.

CMS will send a total of two fee coupons - an initial fee coupon, then a rebill fee coupon 120 days later. Renewal certificates are emailed approximately 1-2 weeks before the current certificate expires.

If payment is not received prior to the expiration date, the certificate will be automatically terminated. A certificate can be reactivated if it has expired; please see the Changes/Renewal section

How Will I Receive My Fee Coupon?

CLIA fee coupons are emailed to the laboratory's contact email address. Emails for fee coupons (and certificates) will come from: noreply-cms-ccsq@ccsq.cms.hhs.gov. This is an official CMS address, not spam. To ensure you receive these important communications, adjust your email settings or spam filters so messages from this address are delivered directly to your inbox.

How Do I Pay My Certificate and Survey Fees?

Starting March 1, 2026, payments must be made through pay.gov, a secure platform hosted by the U.S. Treasury Department. Paper checks will not be accepted after March 1, 2026.

To pay fees online:

1. Go to https://www.pay.gov.

2. Type "CLIA" in the search box in the upper right corner.

3. Enter the CLIA ID number included in your invoice.

CMS accepts bank account (ACH) or debit or credit cards for online payments.

What Happens If I Do Not Pay My Fees?

If payment is not received prior to the expiration date, the certificate will be automatically terminated. A certificate can be reactivated if it has expired; please see the Changes/Renewal section

All fees must be paid to receive your certificate.

Fee Schedule

Certificate of Waiver
The fee for a Certificate of Waiver is $248.00. The certificate is valid for two years. Renewal fee coupons are mailed six months prior to the expiration date of the current certificate.

Certificate of Provider Performed Microscopy Procedures (PPMP)
The fee for a Provider Performed Microscopy Procedures Certificate (PPMP) is $297.00. The certificate is valid for two years. Renewal fee coupons are mailed six months prior to the expiration date of the current certificate.

Certificate of Compliance
There are three separate fees associated with a Certificate of Compliance:

  • Registration Fee. The Registration Fee is a one-time fee of $123.00 assessed to a laboratory that is initially applying for or changing their existing certificate to a Certificate of Compliance. It is valid for two years during which time a survey will be conducted to determine the laboratory’s actual annual test volume amount and regulatory compliance. A Certificate Fee will then be assessed, and, upon receipt of payment, the Certificate of Compliance will be issued to the laboratory.

     

  • Survey Fee. The Compliance Survey Fee is generated twelve months prior to the current certificate’s expiration date. This fee is assessed for the biennial survey that is conducted.

     

  • Certificate Fee. Once the survey is completed and the laboratory is recommended for recertification, the laboratory is issued a Compliance Certificate fee. This fee is assessed to pay for the renewed certificate. The amount of the fee may fluctuate due to changes in the laboratory’s annual test volume and number of laboratory specialties performed.

For a Certificate of Compliance please DO NOT estimate your fees. CMS will calculate the fee amount based on the annual testing volume and number of laboratory specialties performed and generate a user fee coupon for the correct amount.

Certificate of Accreditation
There are three separate fees associated with a Certificate of Accreditation:

  • Registration Fee. The Registration Fee is a one-time fee of $123.00 assessed to a laboratory that is initially applying for or changing their existing certificate to a Certificate of Accreditation. It is valid for two years during which time a survey by the accrediting agency will be conducted to determine the laboratory’s actual annual test volume amount and regulatory compliance.

     

  • Validation Fee. The Validation Survey Fee is generated 6 months prior to the current certificate’s expiration date. This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.

     

  • Certificate Fee. The Accreditation Certificate Fee is billed at the same time as the Validation Fee. This fee is assessed to pay for the renewed certificate. The amount of the fee may fluctuate biennially due to changes in the laboratory’s annual test volume and number of laboratory specialties performed. This fee must be paid to CMS every two years in addition to fees paid to the accrediting agency.

Additional Survey Fees

Rule CMS-332 implemented on 1/27/24 established new fees for the following CLIA program activities:

  •        On-Site Revisit Surveys
  •        Substantiated Complaint Surveys
  •        Proficiency Testing (PT) Desk Review Surveys
  •        Add-On Specialty Surveys

CMS will calculate the laboratory’s fee to cover the costs of these activities. The fee is based on resources and time necessary to perform the tasks.

CMS will revoke the laboratory’s certificate for failure to pay the assessed fees.

For more information, refer to the Federal Register on Register site. Please use search term: CMS-3326-F.

Changes/Renewal Process

  • Requesting Changes to a CLIA Certificate

    All requests for changes to the information pertaining to your CLIA certificate should be submitted in writing within 30 days of the change. If changes are not reported in a timely manner, the CLIA certificate may be issued with incorrect information or terminated for non-payment of fees if the renewal fee coupon cannot reach your facility.

    Depending on the information being updated, changes may be requested by completing a CMS-116 application form or providing written notification. The CMS 116 application must be completed in its entirety.

    CMS does NOT issue new certificates when demographic changes are requested.

    How to Submit a Change Request

    Email the completed CMS 116 application or written notification to LARA-BSC-CLIA@michigan.gov. Change requests can also be faxed to (517)763-0214. Be sure to include the CLIA number in the email subject line or on the fax cover sheet.

    Required Format for Written Requests

    Written notification, preferably on letterhead, must include:

    Laboratory name

    CLIA number

    Name of the Laboratory Director and/or Owner

    The change(s) being made and effective date of the change

    Signature of the Laboratory Director or their designee (someone with the authority to make changes)

    In lieu of written notification, a new form CMS 116 CLIA Application is also acceptable.

    Certain changes require a CMS 116 application. Please see the table below to determine the written documentation required based on certificate type and the change required.

     

    Certificate Type

    Change

    Documentation Required

    Waiver
    • Facility Name
    • Physical address
    • Email address
    • Laboratory Director
    • Tax Identification Number
    • Phone or Fax Number
    • Closure

    Written notification

    OR

    CMS 116 Application

    • Certificate type to Waiver
    • Reinstatement of Certificate
    • Adding multiple site exception- including temporary testing sites. A list of temporary testing sites must be included.
    • Type of Control (Ownership Type)
    • Laboratories with multiple site exception #2 adding or deleting tests from their test menu

    CMS 116 CLIA Application

    PPMP
    • Facility Name
    • Physical address
    • Email address
    • Tax Identification Number
    • Phone or Fax Number
    • Closure/termination

    Written notification

    OR

    CMS 116 Application

    • Laboratory Director
    • Type of Control (Ownership Type)
    • Reinstatement
    • Adding multiple site exception- including temporary testing sites. A list of temporary testing sites must be included.
    • Change Certificate type to PPMP
    • Laboratories with multiple site exception #2 adding or deleting tests from their test menu

    CMS 116 CLIA Application

    Current MI state license

    Compliance
    • Facility Name
    • Physical address
    • Email address
    • Tax Identification Number
    • Phone or Fax Number
    • Closure/termination

    Written notification

    OR

    CMS 116 Application

    • Laboratory Director
    • Type of Control (Ownership Type)
    • Reinstatement
    • Adding multiple site exception- including temporary testing sites. A list of temporary testing sites must be included.
    • Change Certificate type to Compliance
    • Laboratories with multiple site exception #2 adding or deleting tests from their test menu
    • Technical Supervisor - high complexity only

    CMS 116 CLIA Application

    Current MI state license

    Applicable director credential documents

    • Adding and Removing a Specialty

    **Notification required within 6 months of any changes to test menu**

    CMS 116 CLIA Application

    • Technical Supervisor

    Review §493.1449; Technical Supervisor Qualifications and submit applicable documentation.

    Accreditation
    • Facility Name
    • Physical address
    • Email address
    • Tax Identification Number
    • Phone or Fax Number
    • Closure/termination

    Written notification

    OR

    CMS 116 Application

    • Type of Control (Ownership Type)
    • Reinstatement
    • Adding multiple site exception- including temporary testing sites. A list of temporary testing sites must be included.
    • Change Certificate type to Accreditation
    • Laboratories with multiple site exception #2 adding or deleting tests from their test menu

    CMS 116 CLIA Application

    Copy of active MI medical license

    Applicable director credential documents

    • Accrediting Organization (AO)

    CMS 116 CLIA Application

    Evidence of enrollment with AO

    • Laboratory Director
    • Test Specialties
    • Test Volumes

    **These changes must be directed to and processed by the laboratory’s Accrediting Organization**

  • How to Reactivate and Terminate CLIA Certificates

    Reactivation

    An expired CLIA certificate may be reactivated. A certificate that has been expired for less than six months can be reactivated by submitting payment to CMS. Once payment has been received, CMS will issue a certificate and there will not be a gap in the certificate cycle. If the laboratory wishes to make changes to the certificate while in the process of reactivation, a CMS-116 application must be submitted to our office.

    Certificates that have been expired for six months or more can be reactivated by submitting a CMS-116 application. In Section 1, General Information, check the box for “Other” and note “Reactivation” in the space provided.

    Termination

    Facilities that have ceased testing or wish to terminate their CLIA certificate should send written notification to the Michigan CLIA State Agency. Please include the CLIA number, the name and address of the facility, the effective date of the termination, and the reason for termination, (e.g. lab closure, no longer testing, etc.) This notification should be signed by the laboratory director or owner, or an authorized representative of the facility. The notification can be emailed to LARA-BSC-CLIA@michigan.gov.

  • How to Renew a CLIA Certificate

    CLIA Certificate renewal is an automated process initiated by the Centers for Medicare & Medicaid Services (CMS). Unless a certificate has been allowed to expire, it is not necessary for facilities to complete an application to renew their certificate. User fee coupons are generated every two years according to certificate type using the following timeframe:

    Certificate Type

    Fee Timeframe

    Waiver

    Six months prior to the expiration date

    PPMP

    Six months prior to the expiration date

    Compliance

    Survey Fee – Twelve months prior to the expiration date

    Certificate Fee – After the survey has been completed

    Accreditation

    Validation Survey Fee – Six months prior to the expiration date

    Accreditation Certificate Fee – Six months prior to the expiration date

    **These fees are in addition to any fees billed by the selected Accreditation Organization (AO)**

    Renewal certificates are mailed approximately 1-2 weeks prior to the expiration date on the current certificate.

How to Get a Copy of Your Certificate

A copy of what the lab has already been issued.

Additional copies of a laboratory's current certificate may be obtained from:

Revised Certificates

A copy reissued with changes to fields displayed on the certificate, such as name, address, director, or approved specialties or subspecialties. There is a fee associated with each request.

Request a revised certificate by sending an email to LARA-BSC-CLIA@michigan.gov. Include the CLIA number of the lab and Revised Certificate in subject line.

Our office will send a confirmation email when the request has been entered in the CMS system. A fee coupon will be issued and when payment has been posted to the account, the laboratory will receive the requested copy.

Revised Certificate Fees

$95.00 for Certificate of Waiver and Certificate of Accreditation.

$150.00 for Certificate of Registration, Certificate of Compliance, and Certificate of Provider Performed Microscopy.

  • Written notification must include:

    • Type of copy (Replacement or Revised)
    • Laboratory name
    • CLIA number
    • Name of laboratory director AND owner
    • Signature of the laboratory director or their designee (someone with the authority to make changes)
    Type of Copy What you get Fee How to Request

    Replacement Certificate

    		 A copy of what the lab has already been issued. $75.00 for all certificate types Submit Written Notification
    OR
    Submit a completed CMS 116
    Revised Certificate A copy reissued with changes to fields displayed on the certificate, such as name, address, director, or approved specialties or subspecialties. $95.00 for Certificate of Waiver and Certificate of Accreditation

    $150.00 for Certificate of Registration, Certificate of Compliance, and Certificate of Provider Performed Microscopy

    Submit a completed CMS 116

    *If you're only changing name or address, you can submit a written notification instead.
    Our office will send a confirmation email when the request has been entered in the CMS system. A fee coupon will be issued and when payment has posted to their account, the laboratory will receive the requested copy.

The Survey Process

The primary objective of the survey process is to determine compliance with CLIA requirements. The principal focus of the survey is the effect of the laboratory’s practices on patient test results and patient care. The survey is intended to assess the laboratory’s ability to provide accurate, reliable, and timely test results. Although CMS reserves the right to inspect any laboratory issued a CLIA certificate, regardless of certificate type, the majority of Certificate of Waiver (CoW) or Certificate of Provider-Performed Microscopy (PPM) labs are not subject to routine on-site surveys.

  • When Surveys are Conducted

    Surveys are conducted using the following timeframe:

    Certificate Type

    Survey Timeframe

    Waiver

    Onsite surveys are not required

    PPMP

    Onsite surveys are not required

    Compliance
    • Initial survey: 3-12 months after receiving Certificate of Registration; every two years thereafter
    • Recertification survey: within six months of current certificate’s expiration date; surveys are announced and are scheduled 2-14 days in advance of the survey date

    **Surveys are performed by the Michigan CLIA State Agency**

    Accreditation
    • Initial survey: performed by the selected Accreditation Organization (AO) 3-12 months after receiving Certificate of Registration; every two years thereafter
    • Recertification survey: performed by the selected Accreditation Organization (AO) within six months of current certificate’s expiration date
    • Validation survey: performed by the Michigan CLIA State Agency within three months of the accreditation inspection date. These surveys are announced and scheduled 2-14 days in advance of the survey date

    Complaint Investigations & Follow Up Surveys

    All laboratories, regardless of certificate type, that have a complaint filed against them are subject to a complaint investigation survey.

    Any laboratory whose survey results in noncompliance with CLIA requirements is subject to a follow-up/revisit survey.

    Complaint investigations, follow up, and revisit surveys are unannounced.

  • Preparing for Your CLIA Survey

    Pre Survey

    Upon scheduling the onsite survey, the CLIA surveyor will email the following forms:

    1. CMS-116 application
    2. CMS-209 Laboratory Personnel Report Form – Use this form to list all laboratory personnel involved in moderate or highly complex testing.
    3. CLIA Lab Test Menu Form – Use this form to list all tests performed by the laboratory. Tests sent out to a reference laboratory should not be included.

    All forms should be signed and dated prior to the survey date. Please return all pre-survey forms to the surveyor prior to the scheduled survey.

     

    During the Survey

    The survey begins with a brief entrance conference during which the purpose and expected duration of the survey are communicated.

    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 requested. 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 will be determined by whether a negative or potentially negative outcome could exist.

    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. The exit conference is also an opportunity to ask questions and receive clarification from the surveyor if you are unclear on anything found during the survey.

     

    After the Survey

    The surveyor will email the results of the survey to the laboratory in the form of a Statement of Deficiencies (CMS-2567). Alternatively, the results of the survey will be communicated to the laboratory via a Statement of Deficiencies. Laboratories with deficient practices noted on their 2567 will be required to take corrective action. The lab may write or type their plan of correction (POC) directly on the 2567 OR the lab may provide their POC on a separate document. Each deficiency must be addressed, and a completion date provided. The completion date is the date the lab claims it has become compliant with the relevant CLIA regulations. The plan of correction must include:

    1. A step-by-step description of the method(s) used to correct the problem(s) which caused the deficiencies. The plan of correction must provide information that ensures the intent of the regulation is corrected. Simply stating that the problem was corrected is not acceptable. Specific details must be included.
    2. State the method(s) to be used to maintain and monitor compliance. Indicate the staff position(s) responsible for monitoring the correction to prevent the deficiency’s reoccurrence. State your anticipated frequency of monitoring.
    3. A realistic date of correction by month, date, and year.
    4. The first page of the 2567 signed and dated by the laboratory director or their designee.
    5. Instructions on how to complete an acceptable Plan of Correction and examples can be found HERE.

    Any deficiency identified on a survey is subject to a follow-up/revisit survey. For condition-level deficiencies, an acceptable Plan of Correction must be received within 45 days of the survey. Facilities that do not provide an acceptable Plan of Correction within 45 days will be referred to the CMS Chicago office for enforcement.  If immediate jeopardy was identified during the survey, the laboratory must come into compliance within 23 days of the survey to avoid the enforcement process. For more details about the CLIA survey process, see CMS’s Interpretative Guidelines for Laboratories.

     

    Survey Tips

    • Complete all requested forms prior to survey and ensure the laboratory director signs all appropriate documents.
    • Be prepared and organized. Have manuals, documents, and records available at the time of survey.
    • Self-inspect your laboratory. Check storage areas, refrigerators, and freezers for outdated reagents and supplies.
    Ensure key laboratory and administrative personnel are informed of the survey and available.

Complaints

How to File a Complaint

Complaints against a clinical laboratory or allegations of noncompliance with CLIA regulations may be made verbally or, in writing, or anonymously. 

A complaint may be filed using one of the following methods:

  1. Submit a complaint electronically via an online form at the following link: BSC Complaint Intake Form
  2. Call the toll-free Complaint Hotline at (800) 882-6006

Complaint Intake Unit Contact Information

Department of Licensing & Regulatory Affairs
Bureau of Survey and Certification - Health Facility Complaints
PO Box 30838
Lansing, MI 48909

Phone: (800) 882-6006 
Email: LARA-BSC-Complaints@michigan.gov

Multiple/Temporary Sites & Out of State Testing/Sample Collection

Multiple Sites & Temporary Testing Sites

In general, the CLIA regulations require that a laboratory performing testing apply for a certificate for each laboratory location. The regulations do permit the following three exceptions:

1. Laboratories that are not at a fixed location, meaning 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 certificate of the designated primary site or home base, using its address.

2. Nonprofit or federal, state, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests per certificate) public health testing may file a single application. Laboratories with multiple site exception #2 must submit a CMS 116 application when adding or deleting tests from their test menu.

3. Laboratories within a hospital that are located in contiguous buildings on the same campus and under common direction may file a single application or multiple applications for the laboratory sites within the same physical location or street address.

Facilities that qualify may submit their request on the CMS 116 application: see Section V. Multiple Sites. The laboratory should check “Yes” to the question “Are you applying for a single site CLIA certificate to cover multiple testing locations” and indicate which exception applies. Only one exception may be selected. The laboratory should fill out the bottom section 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 using the same format.

Please review CMS policy letter S&C: 12-09-CLIA explaining the CLIA multiple site exceptions.

 

Notification Requirements

Laboratories are required to submit written notification to the Michigan State Agency CLIA program of any change in multiple site status and when changes occur to the number or location of temporary testing sites. CMS memorandum QSO-22-13-CLIA outlines notification requirements for laboratories operating temporary testing sites. Written notification must include:

  • Laboratory name
  • CLIA number
  • Name of laboratory director AND owner
  • The change(s) being made – old information, new information, and effective date of the change
  • Signature of the laboratory director or their designee (someone with the authority to make changes)

In lieu of written notification, a new form CMS 116 CLIA Application is also acceptable. The CMS 116 application must be completed in its entirety.

Written notification or a CMS 116 application may be emailed to LARA-BSC-CLIA@michigan.gov or faxed to (517) 763-0214.

 

Out of State Testing & Sample Collection

Frequently the Michigan CLIA State Agency receives questions regarding testing in Michigan with a CLIA certificate issued from another state or what state licenses are needed for collecting patient samples from Michigan residents that will be processed in another state. Below are examples with responses that address the most asked questions.

We have an active CLIA in another state. Do we have to apply for an out of state CLIA license to accept, collect, and process those patient samples in our laboratory? No. There are no licenses/approvals needed to accept, collect, or process patient samples from Michigan residents in an out of state laboratory. The receiving laboratory must be CLIA certified in accordance with federal law.

We have a CLIA license in another state. Can we cross state lines for Mobile Laboratory Testing using our current CLIA from the other state? Yes, but only if the CLIA certificate has requested a multiple site exception. Contact the CLIA State Agency where the CLIA certificate was issued to request a multiple site exception.

If we can use our current CLIA for mobile laboratory testing, is it limited to waived testing or is moderate complex testing allowed as well? The laboratory may perform all testing permitted under their certificate type. If performing non-waived testing, the laboratory needs to consider the following:

  • When mobile laboratory or temporary testing site equipment is not in use (weekends, overnight) how are instruments, reagents, stains, and other solutions protected from extreme temperature fluctuations? (Interpretive Guidance (IG), page 174)
  • Has the laboratory evaluated potential failures and sources of error due to the transport of instruments and reagents in a mobile laboratory? (IGs, page 205)
  • If equipment and reagents are used in mobile or temporary testing sites, how are they protected from extreme temperature fluctuations when not in use (e.g., evenings, weekends, and holidays)? (IGs, page 244)

Forms/Resources

Fillable Forms

CLIA application form, CMS-116  – The official form issued by the Centers for Medicare & Medicaid Services (CMS) to apply for a CLIA certificate.

CMS-209 Laboratory Personnel Report Form – The official form issued by the Centers for Medicare & Medicaid to list all laboratory personnel involved with moderate and/or highly complex testing.

CLIA Annual Test Menu Form – Form issued by the Michigan CLIA State Agency (SA) to list all tests performed by the laboratory. Tests sent out to a reference laboratory should not be included.

 

Payment Instructions

Online CLIA Payment – Instructions on how to use the Pay.gov system to pay CLIA fees online.

 

CLIA Brochures

CMS created brochures to help explain CLIA regulation requirements.

Brochure - How to Obtain a CLIA Certificate
This brochure explains when a CLIA certificate is required and how to obtain one.

Brochure - How to Obtain a CLIA Certificate of Waiver
This brochure explains when a CLIA certificate of Waiver is required and how to obtain one.

Brochure - Laboratory Director Responsibilities
What are your responsibilities as a laboratory director? This brochure explains the role and responsibilities of the laboratory director.

Brochure - What Do I Need to Do to Assess Personnel Competency?
This brochure explains the requirements for assessing the competency of laboratory personnel.

Brochure - Proficiency Testing and PT Referral
This brochure examines the DOs and DON’Ts of proficiency testing.

Brochure - Verification of Performance Specifications
This brochure provides information to assist your laboratory in meeting the CLIA requirements for verifying the performance specifications of unmodified, moderate complexity tests cleared or approved by the FDA.

Brochure - Calibration and Calibration Verification
This brochure provides information to assist your laboratory in meeting the CLIA requirement of calibration and calibration verification for all nonwaived (moderate and high complexity) test systems.

Brochure - Complaints, Do You Have a Concern About a Laboratory's Operation?
This brochure explains what to do if you have a complaint about a laboratory’s operation.

Brochure - CLIA IQCP, What is an IQCP?
This brochure provides a framework for customizing a quality control program for your test systems and your laboratory’s unique environment.

Brochure - CLIA IQCP, Considerations When Deciding to Develop an IQCP
This brochure provides information on what you need to know when developing an Individualized Quality Control Plan.

Brochure - CLIA Program and Medicare Laboratory Services
This brochure provides an overview of the Clinical Laboratory Improvement Amendments (CLIA) program.

 

Educational Resources

Provider Performed Microscopy Procedures – A Focus on Quality Practices
This booklet describes recommended practices for physicians, mid-level practitioners (nurse midwife, nurse practitioner, or physician assistant), and dentists who perform patient testing under a CLIA Certificate for PPM procedures. The booklet contains an overview of the regulatory requirements, resources including forms and examples, and an overview with images of common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures.

Ready? Set? Test! Booklet
This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.

Ready? Set? Test! Self-assessment Checklist
This checklist highlights best practices for physicians, nurses, and others performing patient tests under a CLIA Certificate of Waiver. It can be used as a voluntary tool to help assure good testing practices and reliable, high-quality test results.

Ready? Set? Test! Online Course
This course offers free continuing education credits. The goal of this course is to promote reliable, high-quality testing and enhance patient safety. This is done by explaining steps of the waived testing process. It also provides the learner with additional resources to assist on the job.

The target audience includes individuals who perform testing in waived testing sites throughout the United States. Examples include physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites. They include a variety of individuals, primarily those who do not have formal laboratory training.

To Test or Not to Test? Booklet
This booklet describes considerations and preparations needed prior to performing waived testing and may assist those who want to implement and oversee waived testing or offer a new test under a CLIA Certificate of Waiver. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site.

Developing an IQCP - A Step-By-Step Guide
This workbook is designed to assist in developing an IQCP for one or more test systems. Using an example scenario, the workbook guides you through a step-by-step process to develop an IQCP that can be sustained and modified, as needed, over time. You will evaluate your current quality activities and develop an IQCP worksheet which, when completed, can serve as your IQCP document. The approach outlined in this workbook is not mandatory or the only format for documentation but is one example that can be used.

Laboratory Director University (LDU)
A free eLearning program from CMS and CDC. LDU delivers valuable training for laboratory directors, laboratory trainers, and other laboratory professional to help maintain regulatory compliance.

CLIA and PPM: An Introduction eLearning course
This course focuses on the CLIA requirements for laboratories and testing sites conducting PPM procedures. This course emphasizes quality practices to prepare licensed physicians, midlevel practitioners, and dentists who perform patient testing under a CLIA Certificate for PPM procedures, as well as those who serve as laboratory directors at laboratories or testing sites that perform PPM procedures.

Test Categorization

The Food and Drug Administration (FDA) has the authority to implement CLIA test complexity categorization. The FDA also has the authority to grant Emergency Use Authorization (EUA) for tests that have not yet been categorized.

FDA CLIA database Online database of FDA approved laboratory testing and their respective categorization.

FDA EUA database FDA online database of all testing granted EUA.

 

Websites

CMS.gov/CLIA
The official website of the Clinical Laboratory Improvement Amendments (CLIA).

CLIA Code of Federal Regulations 42 CFR 493 View the federal regulations applicable to all US clinical laboratories.

CLIA Laboratory Lookup Searchable CMS maintained database of CLIA laboratories.

CDC.gov/CLIA The Centers for Disease Control and Prevention’s CLIA website

CMS Laboratory Registry Once a year CMS makes available specific information that is useful in evaluating the performance of laboratories. This list includes laboratories that have been convicted of fraud, had their certificates revoked, persons convicted of violating CLIA requirements, etc.

Public Notices CMS website to notify the public about Medicare terminations before they take effect.

Contact Information

Department of Licensing and Regulatory Affairs
Bureau of Survey and Certification - CLIA
PO Box 30838
611 W. Ottawa Street, 3rd floor
Lansing, MI  48933

CLIA direct line: (517) 241-2648
Bureau main line: (517) 284-0193
Fax: (517) 763-0214
E-Mail: LARA-BSC-CLIA@michigan.gov