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Become CLIA Compliant:

 

CLIA Waived Testing


If you would like to perform waived testing, but have not yet applied for a CLIA Certificate of Waiver, refer the information below:

Application is as easy as 1-2-3!

  1. Download the application form, (Form CMS-116)
    
The CMS-116 form is available for download at:

    http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf
  2. On Section I of the CMS-116 form, check the box marked "Initial Application", 
complete the remainder of the form and send it to your local state agency.
A list of state agency contact information is available for download at:

    http://www.cms.hhs.gov/CLIA/12_State_Agency_&_Regional_Office_CLIA_Contacts.asp
  3. Upon application approval from your state agency, you will be issued a fee remittance coupon in the amount of $150. Submit your payment, follow manufacturer’s testing guidelines on the waived tests you perform and renew your certificate every 2 years.

What is CLIA?

In 1988, Congressional hearings concerning erroneously read pap smears, and the proliferation of bench top laboratory technology into non-traditional testing sites, led to passage of CLIA. CLIA 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. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, and treatment of a disease or impairment, or to assess health.

Final CLIA regulations were published on February 28, 1992 and are based on the complexity of the test method; thus, the more complicated the test, the more stringent the compliance and oversight requirements. Two categories of tests have been established: waived and non-waived testing. Non-waived testing includes the subcategories of provider-performed microscopy (PPM), moderate complexity and high complexity. CLIA specifies detailed quality standards for the non-waived categories.

Where can I find a list of waived tests?

For a list of waived tests sorted by analyte type, visit the FDA web site at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

For a list of waived tests sorted by the test categorization date and by the test system name,
visit the FDA web site at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm

CLIA Non-Waived Testing

  1. Download the application form, (Form CMS-116) 

    The CMS-116 form is available for download at:
    www.cms.hhs.gov/cmsforms/downloads/cms116.pdfhtt
  2. In Section I of the CMS-116 form, check the box marked "Change in Certification Type." In Section II, check "Certification of Compliance." Check "Certificate of Accreditation" only if you have elected to enroll in a voluntary accreditation program, such as the COLA physician office laboratory program. Complete the remainder of the form and send it to your local state agency.
A list of state agencies is available for download at:
    
www.cms.hhs.gov/CLIA/12_State_Agency_&_Regional_Office_CLIA_Contacts.asprv
  3. Upon application approval from your state agency, you will be mailed a bill for your registration certificate. Receipt of this certificate permits your facility to begin testing.
  4. After payment, enroll in an approved proficiency testing program for all regulated analytes on your test menu.
  5. Establish a policy and procedure manual and a quality assessment plan, perform test method validation, train employees and prepare for inspection.
  6. Pay any inspection fees owed to the state/CLIA program once you receive a bill. Schedule your on-site inspection. Complete the inspection process and correct any deficiencies within the required time frame.
  7. Once your laboratory has successfully completed the inspection process, CMS will issue a bill for the Certificate of Compliance. Fees are assessed based on your annual non-waived test volume and the number of specialties you select.
  8. Maintain a valid and current CLIA certificate (renew every two years) that matches the level of testing performed.

 

Need Help?

Mercedes Medical To the Rescue!

The details of CLIA application can be a bit daunting, but we’re here to help! Additional CLIA resources are located on our new web site at www.POLplace.com. Consulting companies that specialize in CLIA application are also an option to simplify the process. See the ad for Doctors Management on the following page to learn more.

Mercedes Medical Doctor's Management Program!


With your purchase of a moderately complex instrument from Mercedes Medical, we
will pay the cost of the "bronze" support package (a $305 value) for your facility from
Doctors Management!*

Doctor’s management offers regulatory technical consulting services to assist facilities in the process of applying for and maintaining CLIA compliance. They offer several compliance packages to meet the needs of physician’s office laboratories. As a gift to our valuable customers, Mercedes Medical will cover the cost the "Bronze Package" offered by Doctor’s Management under certain condition. This package entitles the bearer to personalized compliance telephone support for three months, 9am-5pm EST, plus 12 months of bi-monthly AAPOL News to keep the recipient updated in the latest compliance changes.

*The instruments that are available for this program are: Abaxis Piccolo xPress®, bioMérieux miniVidas®, Sysmex Poch 100®, and the Beckman Coulter® Ac-T-Diff II. Upon purchase of one or more of those instruments ONLY, Mercedes Medical will pay for the Bronze Package ($305 value) level fo support from Doctors Management, a regulatory and technical services consulting company.