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Click ‘Get Form’ to open the cms 116 PDF in the editor.
Begin by filling out the General Information section. Enter your CLIA Identification Number if applicable, or leave it blank for initial applications. Provide your facility name, Federal Tax Identification Number, email address, and telephone number.
Complete the Facility Address section with the physical location of your laboratory. Ensure accuracy as this is where your fee coupon will be mailed.
In the Type of Certificate Requested section, check only one box that corresponds to your application type (e.g., Certificate of Waiver).
Proceed to indicate the Type of Laboratory by checking the most descriptive option that fits your facility's operations.
Fill in the Hours of Laboratory Testing section using HH:MM format for each day of the week.
If applicable, complete the Multiple Sites section by indicating whether you are applying for a multiple site exception and providing necessary details.
Continue through sections on waived testing, PPM testing, and non-waived testing by specifying tests performed and estimated annual test volumes.
Finally, review all entries for accuracy before signing and dating at the end of the form.
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California Waived: $2,500; In/Out-of-State License Applications: $5,500.
Where do I send my CMS 116 form?
Send the completed Form CMS-116 to the appropriate State Agency ( Legislation/CLIA/Downloads/CLIASA. pdf). Once the completed Form CMS-116 has been returned to the applicable State agency and it is processed, a fee remittance coupon will be issued.
What credentials do you need to draw blood?
Certified Phlebotomy Technician (CPT) Similar to PBT certification, CPT certification is both recognized and sought by employers. Its a definite plus to add to your resume. Eligibility: Youll need a high school diploma or GED and to have completed a formal phlebotomy training program within the last five years.
Which lab tests are CLIA waived?
Common CLIA-Waived Test Examples: Urinalysis (dipstick) Rapid strep and flu tests. Pregnancy tests ()
Do you have to be certified to draw blood?
In California, you must have a license to practice phlebotomy. California has two levels of license: CPT-I: Allows you to do skin puncture and venipuncture. CPT-II: Allows you to do skin puncture, venipuncture, and arterial puncture, but is only needed for specialized work environments.
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People also ask
Do you need a CLIA license to draw blood?
CLIA is the acronym for the Clinical Laboratory Improvement Amendments of 1988. This law requires any facility performing examinations of human specimens (e.g., tissue, blood, , etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services.
Who needs to be a CLIA certified?
Under the CLIA program, clinical laboratories are generally required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates based on test complexity and the types of testing a laboratory conducts.
What is a CMS 116 form?
CMS 116. Form Title. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION. Revision Date.
cms 116 form
clinical laboratory improvement amendments (clia)
Follow the specific instructions on page 3 of the Form CMS-116 when completing this section. (Note: The. Accrediting Organization column should reflect
This transmittal introduces Chapter 40, Hospital and Hospital Health Care Complex Cost Report,. Form CMS Line 116--Are you classified as a referral center?
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