Types of CLIA Certificates
Certificate of Waiver
In an effort to provide support to workplaces who may be doing COVID-19 testing, CMS has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-19 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet.
Please note: CMS is temporarily exercising enforcement discretion and allowing employers to start waived SARS-CoV-2 Point of Care testing after a facility has submitted a CMS-116 application.
A Certificate of Waiver allows a facility to perform only tests that are classified as waived. 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. CMS maintains a complete list of waived tests.
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 with a Certificate of Waiver.
Although laboratories with a Certificate of Waiver are not subject to routine on-site surveys, as of April 2002 through the CLIA Waived Laboratory Project, a small percentage of these laboratories may receive on-site visits to provide educational information and encourage quality laboratory testing.
Certificate for Provider Performed Microscopy Procedures (PPM)
The Certificate for Provider Performed Microscopy Procedures (PPM) is issued to facilities that perform a limited list of tests requiring microscopic procedures. PPM tests are considered moderately complex; therefore, the facility must comply with CLIA regulations for moderate complexity testing. Examples of PPM testing include: wet mounts and KOH preps. CMS maintains a complete list of PPM tests.
The director of a PPMP facility must be a state licensed physician, midlevel practitioner or dentist. When submitting an application for a PPMP certificate, the facility must provide a copy of the director’s current TN medical license, nursing license or dental license.
A facility with a PPM certificate type can also perform waived tests.
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/or high complexity laboratory testing until the survey is performed and the laboratory is found to be 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 high complexity testing, a facility that is 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 to be in compliance with all applicable CLIA requirements.
Surveys for Certificate of Compliance laboratories are conducted by Tennessee Department of Health State Agency surveyors. Surveys for recertification of laboratories are conducted 6 – 12 months prior to the expiration date of the certificate.
The director of a Compliance facility must be qualified to oversee non-waived testing. When submitting an application 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 also 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 to be 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 submitting an application 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 also perform PPM and waived testing.