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.
Any facility or provider that performs laboratory tests on human specimens for the purpose of diagnosis and/or 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:
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
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 9 approved microscopic procedures. PPM tests are considered moderately complex; therefore, the facility must comply with CLIA regulations for moderate complexity testing. The 9 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, midlevel 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.
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/or 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 12 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.
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.
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.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 GuideLaboratory Director Qualification. CLIA regulations specify qualifications for laboratory directors to oversee non-waived 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 Qualifcation 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
Documentation of Experience and/or Training
Accreditation Enrollment. Applicants for a Certificate of Accreditation should provide evidence of enrollment with one of the 7 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 11 months after receipt of the Certificate of Registration.
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.
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. Laboratories enrolled in the eCert program will receive their fee coupon via email. If not enrolled in eCert, the laboratory will receive a user fee coupon (bill) from CMS via US Mail in about 2-3 weeks. The fee coupon states the facility’s CLIA number, correct fee amount based on certificate type, and instructions on where and how to send in payment. Fee coupons should be included when submitting CLIA payments to ensure payments are applied to the correct facility. If you do not have a copy of the fee coupon, include your CLIA number on the check. You can also choose to pay your bill electronically.
DO NOT SEND PAYMENT TO THE STATE OF MICHIGAN
Upon receipt of payment, the CLIA account will be activated and the lab’s CLIA certificate mailed to the mailing address provided on the application. If a mailing address was not provided, the certificate will be mailed to the facility’s physical address.
Laboratories may now select to receive electronic copies of CLIA certificates. To receive an electronic copy of a CLIA certificate, the laboratory must an email address and check the "Receive Future Notifications via Email" box in Section I. General Information of the CMS 116 application.
When all fees are paid, CMS will email a link to the electronic CLIA certificate. Laboratories may print the certificate from the link. CMS will also send a paper copy of the CLIA certificate via US Mail.
Starting in September 2023, the CMS Laboratory Lookup website, S&C QCOR, features a URL link to certificates beginning a new cycle. By 2025, all certificates will have a URL link.
**Effective 1/27/24, CMS implemented new fees for surveys and a fee increase for all certificate types**
CMS is responsible for all fees for CLIA certification. PAYMENT FOR CLIA FEES SHOULD NEVER BE SENT TO THE STATE OF MICHIGAN.
CMS will automatically generate a fee coupon when initial applications are processed and when an existing certificate is due to be renewed. Upon receipt of the fee coupon, follow the instructions provided on how to make payment. Payments may be submitted by US Mail or electronically, see Payment section for details. CLIA payments sent via US Mail should be submitted with the fee coupon. If you do not have a copy of the fee coupon, please include the CLIA ID number on the check or money order. Checks/money orders should be made payable to CLIA LABORATORY PROGRAM and mailed to the following address:
CLIA LABORATORY PROGRAM
PO BOX 3056
Portland, OR 97208-3056
CMS will send a total of 2 fee coupons - an initial fee coupon, then a rebill fee coupon 120 days later. Renewal certificates are mailed 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 Changes/Renewal section.
Certificate of Waiver
The fee for a Certificate of Waiver is $248. 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. 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 3 separate fees associated with a Certificate of Compliance:
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 3 separate fees associated with a Certificate of Accreditation:
Additional Survey Fees
Rule CMS-332 implemented on 1/27/24 established new fees for the following CLIA program activities:
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.
US Mail to the PO Box. Payment made by check or money order should be made payable to CLIA LABORATORY PROGRAM and mailed to:
CLIA LABORATORY PROGRAM
PO BOX 3056
Portland, OR 97208-3056
Fee coupons should be submitted with the check or money order. To ensure payments are applied to the correct laboratory, always write the CLIA ID number on the check or money order.
Online payment by credit card. Facilities that wish to make a payment by credit card can do so online through the Pay.gov website. Instructions to guide you through the process can be found HERE.
All changes made 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, mailed to the wrong address, or terminated for non-payment of fees if the renewal fee coupon cannot reach your facility. Furthermore, the Centers for Medicare & Medicaid Services (CMS) will not reissue a CLIA certificate for changes in demographic information, such as facility name, physical address, or laboratory director. These changes will appear on the next renewed certificate.
Written notification must include:
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.
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 requested.
Certificate Type |
Change |
Documentation Required |
|
Waiver |
|
Written notification OR CMS 116 Application |
|
|
|
|
|
PPMP |
|
Written notification OR CMS 116 Application |
|
|
|
Copy of active MI medical license |
|
Compliance |
|
Written notification OR CMS 116 Application |
|
|
|
Copy of active MI medical license |
|
|
**Notification required within 6 months of any changes to test menu** |
|
|
|
|
Review §493.1449; Technical Supervisor Qualifications and submit applicable documentation. |
|
Accreditation |
|
Written notification OR CMS 116 Application |
|
|
|
Copy of active MI medical license |
|
|
|
Evidence of enrollment with AO |
|
|
|
**These changes must be directed to and processed by the laboratory’s Accrediting Organization** |
An expired CLIA certificate may be reactivated. A certificate that has been expired for less than 6 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 6 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.
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, i.e., 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.
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 2 years according to certificate type using the following time frame:
Certificate Type |
Fee Timeframe |
|
Waiver |
6 months prior to the expiration date |
|
PPMP |
6 months prior to the expiration date |
|
Compliance |
Survey Fee – 12 months prior to the expiration date Certificate Fee – After the survey has been completed |
|
Accreditation |
Validation Survey Fee – 6 months prior to the expiration date Accreditation Certificate Fee – 6 months prior to the expiration date **These fees are in addition to any fees billed by the selected Accreditation Organization** |
Renewal certificates are mailed approximately 1-2 weeks prior to the expiration date on the current certificate.
Laboratories may request an additional printed copy of their CLIA certificate. There is a fee associated with each request. Laboratories may choose either a Replacement copy or a Revised copy.
Depending on the type of copy desired, a complete CMS 116 application may be required. Requests can be submitted to our CLIA email address, LARA-BSC-CLIA@michigan.gov, or via fax.
Written notification must include:
| Type of Copy | What you get | Fee | How to Request |
|
Replacement Certificate |
A copy of what the lab has already been issued. | $75 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 for Certificate of Waiver and Certificate of Accreditation $150 for Certificate of Registration, Certificate of Compliance, and Certificate of Provider Performed Microscopy |
Submit a completed CMS 116 *If only changing Name and/or Address can opt to submit written notification |
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/or patient cate. 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.
Surveys are conducted using the following time frame:
Certificate Type |
Survey Timeframe |
|
Waiver |
Onsite surveys are not required |
|
PPMP |
Onsite surveys are not required |
|
Compliance |
**Surveys are performed by the Michigan CLIA State Agency**
|
|
Accreditation |
|
|
Complaint Investigations & Follow Up Surveys |
All laboratories, regardless of certificate type, who have a complaint filed against them are subject to a complaint investigation survey. Any laboratory whose survey results in non-compliance with CLIA requirements is subject to a follow-up/revisit survey. Compliant investigations and follow-up/revisit surveys are unannounced. |
Upon scheduling the onsite survey, the CLIA surveyor will email the following forms:
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.
The survey begins with a brief entrance conference at which time 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 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. 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.
The surveyor will email the results of the survey to the laboratory in the form of a Statement of Deficiencies, CMS-2567. Or The results of the survey will be communicated to the laboratory via a Statement of Deficiencies, CMS-2567. Laboratories with deficient practice 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 is alleging they will be compliant with CLIA regulations. The plan of correction must include:
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 with 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.
Complaints against a clinical laboratory or allegations of non-compliance with CLIA regulations may be made verbally or in writing and anonymously.
A complaint may be filed using one of the following methods:
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
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, that is, 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. Not-for-profit 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.
3. Laboratories within a hospital that are located at 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.
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:
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.
Frequently the Michigan CLIA State Agency receives questions regarding testing in Michigan with a CLIA certificate issued from another state and/or what state licenses are needed regarding 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:
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.
Online CLIA Payment – Instructions on how to use the Pay.gov system to pay CLIA fees online.
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 for laboratory personnel.
Brochure - Proficiency Testing
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 requirement 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.
Provider Performed Microscopy Procedures – A Focus on Quality Practices
This booklet describes recommended practices for physicians, midlevel 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.
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.
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 databaseFDA online database of all testing granted EUA.
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.
The COVID-19 Public Health Emergency (PHE) ended on May 11, 2023. The CLIA requirement for laboratories to report SARS-CoV-2 results expired with the termination of the PHE. CMS issued CLIA specific post public health emergency guidance in memorandum QSO-23-15-CLIA.
Federally certified facilities, such as long-term care facilities, may still be required under their provider specific regulation set to report and track COVID-19 test results. CMS issued guidance for the expiration of the COVID-19 Public Health Emergency in memorandum QSO-23-13-ALL.
The Michigan Department of Health and Human Services (MDHHS) no longer requires reporting of COVID-19 test results. If an individual test positive, it is recommended to report to the local health department.
Questions regarding COVID-19 result reporting? Email MDHHS-COVIDTestingSupport@michigan.gov
Department of Licensing and Regulatory Affairs
Bureau of Survey and Certification - CLIA
PO Box 30838
611 W. Ottawa Street, 1st floor
Lansing, MI 48909
CLIA direct line: (517) 241-2648
Bureau main line: (517) 284-0193
Fax: (517) 763-0214
E-Mail: LARA-BSC-CLIA@michigan.gov
