How to Become a CLIA Certified Laboratory

Congress established the Clinical Laboratory Improvement Amendments (CLIA) in 1988 to ensure that patients' laboratory tests were being handled by labs qualified to handle them. Every lab in the United States that handles human test samples is required to obtain CLIA certification. Certain simple tests can be performed under a Certificate of Waiver, but if you want to perform tests that require complex procedures, you'll need a full CLIA certification.

Things You'll Need

• Laboratory
• CLIA Application for Certification Form (Form CMS-116)
• State laboratory director license (if required by your state)
• Credentials as a doctor, independent midlevel practitioner or dentist
• Sufficient personnel for the expected volume of tests

Instructions

1. Fill in the "General Information" section with your lab's name, address and other contact information. If you aren't currently CLIA-certified, leave the "CLIA Identification Number" box blank.

2. Check the "Certificate of Compliance" box in the "Type of Certificate Requested" section. Continue to the "Type of Laboratory" section. Select the option that best describes your lab. If none fits, check "Other" and supply a description of your lab.

3. Fill in Section IV with the hours you'll be offering tests, then select whether you'll be testing at more than one site. If you only have one location to certify, continue to Section VI, "Waived Testing."

4. Fill in the number of "Waived", "Provider Performed Microscopy" (PPM) and "Non-waived" tests you expect to perform at your lab each year. Waived tests are simple and have a minimal chance of inaccuracy. PPM tests are generally more complex and are analyzed by physicians in their own offices. Non-waived tests are the most complex and may require separating blood into components or other sensitive procedures that require expertise. Fill in the number of each type of non-waived test that you expect to perform each year.

5. Under "Type of Control", select the option that best describes your lab's affiliations. In the next section, note whether the lab's director oversees any other labs. Sign the application.

Next Steps

1. Locate the office in your state that administers CLIA (see Resources).

2. Send your local office your application and copies of all credentials, including your license to operate a laboratory (if required in your state), your laboratory experience and documents establishing that you are either a licensed physician, independent midlevel provider or a dentist. You'll need at least one year of supervisory lab experience in a licensed lab before you can direct your own. For high-complexity tests you'll need at least two years of supervising similar tests.

3. Once the state agency has received your application, they will send you a coupon detailing the fees you must submit and schedule a date for an inspection (if applying for a Certificate of Compliance). Submit these fees. When the inspector visits, give him or her access to all requested records and areas covered by certification. The inspector may also test your staff for proficiency in carrying out the tests you expect to perform and will interview them to ensure that you have effective quality control procedures in place. For instance, you must have an effective procedure in place for minimizing cross-contamination of test samples.

4. Begin testing if you pass your inspection. If not, you will receive a list of items that must be improved within 45 days. As soon as these items are improved, send proof of improvement to your state health department, which will then issue a certificate.

5. Renew your certification every two years.

Tips & Warnings

• If you're only planning to administer Waived tests or Provider-Performed Microscopy tests, apply for a Certificate of Waiver or a Certificate for PPM. Neither of these certifications requires an inspection.

• Specific federal benchmarks apply to each test type, so refer to the applicable sections of the CLIA regulations to ensure that you and your staff are proficient (see Resources).

• Laboratories in Washington State and New York do not need to register with CLIA. These states have their own certification requirements that meet or exceed CLIA's.

• Don't embellish your credentials or try to operate without certification. Either of these actions could lead to a fine, jail time or both.

References

• Centers for Medicare and Medicaid Servicess: How to Apply for a CLIA Certificate
• Centers for Medicare and Medicaid Services: How to Obtain a CLIA Certificate
• Centers for Disease Control: CLIA Regulations

Resources

• U.S. Department of Health and Human Services: Form CMS-116
• Centers for Medicare and Medicaid Services: CLIA Contacts by State
• Centers for Disease Control: CLIA Regulations