Lab testing is an essential part of any medical practice’s day-to-day operations. It helps monitor patient health, detect and prevent disease, and enables clinicians to get results quickly and accurately. Whether you have an on-site laboratory or work with an outside testing agency, your laboratory must be CLIA certified.
CLIA or Clinical Laboratory Improvement Amendments are a series of government sanctions amendments that regulate laboratory testing in the U.S. To receive payment from Medicare and Medicaid, your testing facility must be accredited by CLIA.
How To Become a CLIA Certified?
The first step in becoming CLIA certified is to fill out CMS Form 116, which can be accessed by visiting CMS.gov. This form will ask various questions about your laboratory. Also, about its operations, and processes, and will determine what based on your answers.
Your laboratory or the laboratory you work with must be accredited by your state and federal government. Make sure your physician must check the accreditation of any labs you plan to work with and start the accreditation process at least a few months before your lab opens.
CLIA Certification Types
There are five different types of CLIA certifications that are valid for two years. Except for the Certificate of Compliance and the Certificate of Accreditation. Each certificate is renewed by paying a certificate fee. Renew certificates of conformity and accreditation, then conduct inspections and pay fees. The issuance of updated CLIA fees is an automated process that does not require any action by the laboratory.
Waived Tests certificate
Exemption certificates are issued to laboratories for the sole purpose of conducting exempt tests. This certification does not exempt you from all CLIA requirements. FDA determines the complexity of laboratory tests (compromised, moderate, highly complex).
Waiver tests are simple and easy to perform laboratory tests. An example of an exempt test is a fingertip blood sugar test using a blood glucose meter. The complexity of the test can be reviewed through the FDA’s database. Exempt accredited laboratories do not have routine inspections.
However, as of April 2002, two percent (2%) of exempt accredited laboratories are visited annually to ensure the quality of laboratory testing. Although this is a relatively small percentage of laboratories, all laboratories holding an exemption certificate are eligible for on-site visits.
Certificate for Provider Performed Microscopy Procedure
PPM certification is issued to a laboratory for a physician, mid-level practitioner, or dentist performing limited testing that requires microscopy. PPM tests are of moderate complexity; therefore, the CLIA standard applies to tests of moderate complexity. An example of PPM testing is a wet installation.
The director of a PPMP facility must be a state-licensed physician, mid-level practitioner, or dentist. When applying for PPMP certification, facilities must provide a copy of the supervisor’s current medical license, nursing license, or dental license.
Certificate of Registration
A certificate of registration is a certificate originally issued to a laboratory that has applied for a certificate of conformity or accreditation. This accreditation allows laboratories to perform moderately and/or highly complex laboratory tests until an investigation is conducted and the laboratory is determined to comply with CLIA standards.
The Certificate of Entry includes both the PPM exam and the exemption exam. As well as, all medium and high complexity exams.
Tests are required for all registered accredited laboratories. The test will take place between 90 days and 12 months after the effective date of the certificate. So that actual verification can be observed during the examination.
Certificate of Compliance
A certificate of compliance is proof that a laboratory is allowed to perform tests of medium and/or high complexity. This certificate will be issued to the laboratory upon inspection to determine that the laboratory complies with all applicable CLIA requirements.
Compliance certification includes PPM testing and exemption testing, as well as all medium and high complexity testing.
Inspections are required for all compliant accredited laboratories. Inspections of the Louisiana Compliance Certification Laboratory are conducted by the Louisiana Department of Health’s State Agency Inspectors. Laboratory re-accreditation inspections are conducted 6 to 12 months before the accreditation expiration date.
Certificate of Accreditation
This is an accreditation that allows a laboratory to conduct tests of medium and/or high complexity. This certificate will be issued to the laboratory upon inspection to determine that the laboratory complies with all applicable CLIA requirements.
Laboratories must select a specific accreditation body and indicate that choice on the CLIA application. Once a facility is registered with the organization, it must submit proof of registration with the Louisiana CLIA program.
Certification includes the PPM exam and waiver exam, as well as all intermediate and high complexity exams.
Testing is required for all accredited laboratories. Inspections are carried out by inspectors from the accredited institution you are applying for. The inspection is carried out by the agreement of the designated accreditation body.
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