Personnel requirements tie into the complexity of testing. The condition differs for personnel who execute moderate- and high-complexity testing and are identified individually. Define qualifications for a precise mixture of positions and accountability.
All laboratories must have one of the below CLIA certifications to perform clinical testing on specimens:
- Certificate of Waiver is issued to a laboratory to perform waived tests only.
- Certificate of Provider-Performed Microscopy Procedures is issued to a laboratory in which a mid-level practitioner, physician or dentist can perform microscopy procedures. Waived tests may also be performed.
- Certificate of Registration is issued to a laboratory that performs moderate and/or high complexity testing until it is determined by a survey to be in compliance with CLIA regulations.
- Certificate of Compliance is issued to a laboratory after an inspection determines that it is compliant with CLIA requirements.
- Certificate of Accreditation is issued to a laboratory on the basis of the accreditation of an organization approved by CMS.
Once the certification(s) is obtained, the physicians should evaluate which laboratory tests are covered. Medicare noncovered services should be accompanied by an Advanced Beneficiary Notice (ABN). If a physician has unassigned claims, the beneficiary or their representative must agree to be financially responsible for the noncovered services by applying their signature in the appropriate section. This ensures the physician services will be compensated by the beneficiary receiving the services. Assigned claims do not require a signature from the beneficiary or their representative; the physician can simply have a witness sign the form documenting the beneficiary’s refusal, and ABN will be effective.
ABNs are not required for such services as screening tests, cosmetic surgery and routine physicals. Nevertheless, physicians should be cautious in determining when to use an ABN, because some of the excluded categories could be covered under other circumstances. For example, when screenings, such as mammography, may prove unclear about whether it’s covered under Medicare, it’s better to acquire an ABN.
How to Apply for a CLIA Certificate of Waiver
Apply for a Certificate of Waiver via form CMS-116, which can be obtained on the CMS website at http://www.cms.gov/clia/cliaapp.asp or from your state health department. The application requests the following information to be complete:
- General Information—Provide information about your organization, including street address, name of director and federal tax identification number. Don’t fill out the CLIA identification number if this is an initial application.
- Type of Certificate Requested—Request a Certificate of Waiver.
- Type of Laboratory—Indicate the facility or setting in which you will perform the rapid test (e.g., community clinic, health fair, mobile laboratory [van]). If none of the categories applies to your setting, check “other.”
- Hours of Laboratory Testing—Indicate the times you plan to do testing.
- Multiple Sites—Indicate if you will be doing testing at more than one site. If you will have multiple sites, provide the number of sites and complete the remainder of this section. In general, a mobile van is considered a multiple site if it is not in a fixed location and moves from site to site for testing. The name and address of the testing site for that van would be the same as the organization it operates under or the physical location where the van is housed.
- Waived Testing—Estimate the number of tests you will be performing annually.
- Non-Waived Tests—Skip this section if you are performing a waived test only.
- Type of Control—Check the type of organization for which you are making this application—private nonprofit, for-profit, government).
- Director Affiliation with Other Laboratories—Provide the name and address of other laboratories that your director also directs. CLIA regulations allow a director to direct a maximum of five laboratories.
- Individuals Involved in Laboratory Testing—Indicate the total number of individuals who are directing, supervising, consulting or testing. Include counselors only if they will perform or supervise testing.
- Consent & Signature—Carefully read the consent information at the bottom of p. 4 before signing and dating.
The Certificate of Waiver application should be forwarded to the address of the local state agency in which the testing will be performed. CMS has a list of these agencies at http://cms.hhs.gov/clia/ssa-map.asp. You can also contact your state agency for assistance in filling out the application. You will need to submit a fee of $150 with the application.
