CLIA: Frequently Asked Questions

What certificate types are available?

Certificate of Waiver

These tests have been approved by the FDA for home use and require very little training to perform. The only requirements for this type of testing are that the manufacturer's instructions are followed exactly and perform only waived tests. It is recommended that each laboratory follow good laboratory practice, including documenting the training performed for each person performing tests. Proficiency testing is not required for this level of testing.

Provider-Performed Microscopy (PPM)

These are tests performed by a healthcare provider, such as a doctor, physician's assistant, or nurse practitioner. These tests include: microscopic sediment analysis, wet preps, KOH preps, and other microscope-based procedures. All waived tests may be performed with this level of certificate with the same requirements as a certificate of waiver. Proficiency testing is not required for this level of testing.

Certificate of Compliance

Tests performed under this type of certificate have been classified as moderate or high complexity and have regulations that are more stringent. Facilities performing moderate or high complexity testing must be enrolled in an approved proficiency testing program for each regulated analyte. Analytes that do not have a proficiency testing program available must be evaluated at least twice a year. Each facility must establish a quality assurance program that includes quality control, personnel policies, patient test management, and proficiency testing. These facilities are inspected every two years to ensure compliance with federal regulations.

Certificate of Accreditation

Facilities with this type of certificate have opted to have a CMS-approved accrediting agency perform the biannual inspections instead of CMS for an additional fee. These facilities must follow the accrediting agency's guidelines in addition to the federal regulations. Occasionally, a validation inspection is conducted to evaluate the accrediting agency inspection process.

Types of CLIA Certificates

What are the requirements for testing personnel?

Subpart M contains the personnel sections of the CLIA regulations (493.1351 through 493.1495).

• For tests classified as moderately complex, testing personnel must have at least a high school diploma or G.E.D. and documentation of training before performing tests.
• For tests classified as high complexity, testing personnel must have an associate of science degree or higher and documentation of training before performing tests.
• All personnel must be evaluated within six months of hire and annually thereafter.
• There are no personnel requirements for waived testing.
• To perform PPM testing under the PPM certificate, you must be a licensed mid-level practitioner (i.e.,  doctor, physician's assistant, or nurse practitioner).

What kinds of facilities are subject to inspections?

All facilities performing laboratory testing are subject to inspection by CMS. Only certificate of compliance and certificate of accreditation laboratories have routine inspections every two years. Complaint investigations are performed as needed.

What is the survey or inspection process?

The surveyor will schedule routine surveys within six months of the certificate expiration date. Complaints and re-visit surveys are always unannounced. The surveyor will review all documents related to laboratory testing including, but not limited to, procedure manuals, test records, personnel files, and patient records. Failure to voluntarily provide this information may result in sanctions against your CLIA certificate and may affect Medicare reimbursements. Facilities are given the opportunity to correct all deficiencies within a specified period. Standard deficiencies must be corrected within a reasonable period, not to exceed 12 months.

Clinical Laboratory Improvement

Does Indiana have any state regulations for laboratories or laboratory personnel?

Currently, the Indiana Department of Health (IDOH) does not license laboratories or laboratory personnel. IDOH does have rules for communicable diseases and universal precautions that must be followed. These rules can be found here.

Other state agencies, such as the Indiana Department of Environmental Management (IDEM) or Indiana State Board of Animal Health (BOAH), may have state statutes and regulations that apply to your laboratory.

CLIA regulations state that only an authorized person may order tests. What does this mean?

CLIA defines an "authorized person" as someone who has specific authorization from the state in which the test is performed.

D5301 § 493.1241 Standard: Test Request

(a) The laboratory must have a written or electronic request for patient testing from an authorized person.

Interpretive Guidelines § 493.1241(a)

An “authorized person” means an individual authorized under state law to order tests or receive test results, or both.

Some states expressly authorize patients to order tests or receive (or give them access to) test results regardless of who ordered the test. In these states, a laboratory may release test results directly to a patient as an “authorized person” in accordance with state law. Patients may also be considered “individuals responsible for using test results” if state law does not expressly prohibit release of test results directly to patients. If the laboratory is requesting payment under Medicare, the laboratory must follow the requirements in the Social Security Act regarding test ordering for Medicare reimbursement.

Indiana does not currently have any statutes that define an "authorized person." However, the Medicare regulation specifies that the "authorized person" must be a doctor with a current state medical license.

Additional Resources

• Indiana Board of Nursing
• Indiana Board of Pharmacy
• Indiana Professional Licensing Agency

Can patients order their own tests in Indiana?

Yes, this practice is known as direct access testing (DAT) and, currently, Indiana law does not prohibit patients from ordering their own tests. However, Medicare and Medicaid will not pay for any laboratory testing not ordered by an authorized person.

Specific licensed entities may have additional requirements under their specific license. Such as for hospitals under 410 IAC 15-1-5.3(a)(2), “The laboratory performs tests and examines specimens on the written request of individuals and practitioners allow to order such evaluations and receive the results of the evaluations to the extent permitted by law and authorized by the governing body.” It is also at the discretion of the laboratory to decide whether or not to provide DAT.

• Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulation

How do I renew my CLIA certificate?

Billing coupons are mailed from the U.S. Department of Health & Human Services (HHS). Coupons for a certificate of wavier, certificate of microscopy, and certificate of accreditation renewals will be mailed out six months prior to your current certificate expiration date. After full payment is received, your next two-year certificate cycle is considered renewed. Your CLIA certificate will not be mailed to you until approximately two weeks before your current certificate expires.

Compliance fee coupons for CLIA certificate of compliance renewals are mailed out 12 months prior to your current certificate expiration date. Full payment must be received before a compliance survey will be scheduled by IDOH. Once IDOH performs the survey and determines that your laboratory is compliant with applicable CLIA regulations, a certificate fee coupon will be mailed to you. After full payment of the certificate fee is received, your next two-year certificate cycle is considered renewed.

Where do I send the payment for my CLIA certificate?

Check Instructions

CLIA Laboratory Program

Mailing Address

CLIA Laboratory Program
P.O. Box 3056
Portland, Oregon 97208-3056

Instructions

Write your CLIA identification number on the check and include the billing coupon with your payment.

Click here for instructions for paying online.

When will I receive my new CLIA certificate?

Renewed CLIA certificates will be mailed or emailed (if you requested future correspondence to be via email) approximately two weeks prior to your current expiration date if full payment of CLIA fees is received. Initial CLIA certificates will be mailed or emailed (if you requested future correspondence to be via email) approximately two weeks after full payment of CLIA fees is received.

How do I request changes to my CLIA certificate?

A new CMS 116: CLIA Application is completed for any change. Please click here and follow instructions.

Documentation Required for Changes

Required: CMS 116: CLIA Application, Enclosure A: Disclosure of Ownership, and Enclosure I: Methodology Test List

• Initial application (all types, including certificate of waiver).
• For a provider-performed microscopy procedure (PPMP), certificate of compliance (COC), and certificate of accreditation (COA), please also include information to qualify the director (e.g., license for physicians, all other director-level diplomas/transcripts, board certification, additional training through laboratory university, etc.).

Required: CMS 116: CLIA Application and Enclosure I: Methodology Test List

• Change of certificate (other than certificate of waiver [also need information to qualify the director]).
• Change of director (PPM, COA, and COC) plus information to qualify the director.
  • PPM: Indiana license.
  • COC: license for physicians, all other director-level diplomas/transcripts, board certification, and continuing education (CE) courses for laboratory director responsibilities.
  • COA: license for physicians, all other director-level diplomas/transcripts, board certification, and continuing education (CE) courses for laboratory director responsibilities.
  • Reinstatement of CLIA certificate after being closed for at least six months.

Required: CMS 116: CLIA Application

• Multi-site exception request. Exception number two requires not-for-profit documentation.
• Exception number three requires a map showing laboratories in contiguous building on the same campus.

Do not send change requests with your payment. Requests to change facility name, address, tax ID, mailing address, or laboratory director must be reported to IDOH within 30 days of the change. Requests to change your CLIA certificate type must be submitted on the CMS-116: CLIA Application before you perform any tests not covered under your current certificate.

Submitting Requests

Change requests may be faxed, emailed, or mailed to IDOH.

Fax

317-233-7157

Email

• LSwitzer@health.in.gov,
• KLara@health.in.gov, or
• IndianaCLIA@health.in.gov

Mailing Address

Indiana Department of Health
ATTN: CLIA Program
2 North Meridian Street #4A
Indianapolis, Indiana 46204

When applying for a provider-performed microscopy procedure (PPM) certificate, certificate of compliance, or certificate of accreditation, what additional information/documentation is required?

Laboratory directors performing non-waived testing (including PPM) must meet specific education, training, and experience under Subpart M of the CLIA requirements. Proof of these requirements for the laboratory director must be provided and submitted with the application.

Information to be submitted with the application may include:

• Verification of state licensure, as applicable.
• Documentation of qualifications:
  • education (copy of diploma, transcript from accredited institution, continuing education [CE] courses),
  • credentials, and
  • laboratory experience.

Individuals who attended schools outside of the United States must have an evaluation of their credentials determining equivalency of their education to education obtained in the United States. Failure to submit this information will delay the processing of your application. Please call 317-233-7502 for further information.

Documentation of Laboratory Accreditation

• When submitting an application for a certificate of accreditation, you must also submit documentation showing that you have contacted the laboratory accrediting program to seek laboratory accreditation for your laboratory.
• Acceptable documentation includes a copy of a letter from the laboratory to the accrediting program requesting laboratory accreditation, a copy of the laboratory accreditation application submitted to the accrediting program, or a welcome letter from the accrediting program to the laboratory.

Change of Director Documentation Needed

What are the requirements to qualify as a laboratory director for a certificate of compliance or certificate of accreditation laboratory?

The regulatory education and training requirements for a laboratory director depend upon the complexity of laboratory testing performed. A state-licensed physician who is board-certified or board-eligible in anatomic or clinical pathology meets the requirements to direct a laboratory of any complexity. All other individuals who wish to direct a laboratory holding a certificate of compliance or a certificate of accreditation should call 317-233-7502 for further information.

Laboratory Director Qualifications

Subpart M contains the personnel sections of the CLIA regulations (493.1351 through 493.1495).

• Certification Boards for High-Complexity Laboratory Directors
• Click here for continuing education (CE) courses for laboratory directors.

Can I have more than one location under the same CLIA number?

CLIA certificates are location-specific, therefore, if you perform testing at more than one location, then you will have more than one CLIA certificate unless you qualify for a multi-site site exception and complete a CMS 116: CLIA Application for the multi-site exception.

To qualify for a multi-site exception, your laboratory must meet one of the below criteria:

1. Temporary testing, such as a health fair, may file a single application.
2. A not-for-profit or federal, state, or local government laboratory engaged in limited public health testing (no more than 15 total tests for all sites, waived or moderately complex) may file a single application.
3. Laboratories within a hospital, located in contiguous buildings on the same campus, and that are under common direction may file a single application. Hospital satellites or auxiliary laboratories located outside a hospital must each make a separate application.

I am no longer performing laboratory testing in my office. How do I terminate my CLIA certificate?

Requests to terminate your CLIA certificate must be submitted to IDOH in writing. Please include the laboratory name, CLIA number, name of the laboratory director and/or owner, the reason your certificate should be terminated, the effective date of termination, your laboratory contact information, and the signature of the laboratory director or his/her designee.

Submitting Requests

Requests may be faxed, emailed, or mailed to IDOH.

Fax

317-233-7157

Email

• LSwitzer@health.in.gov,
• KLara@health.in.gov, or
• IndianaCLIA@health.in.gov

Mailing Address

Indiana Department of Health
ATTN: CLIA Program
2 North Meridian Street #4A
Indianapolis, Indiana 46204

What is the cost for a CLIA certificate?

• Certificate of waiver: $248.00 for a two-year certificate.
• Certificate of provider-performed microscopy procedures: $297.00 for a two-year certificate.
• Certificate of compliance or certificate of accreditation: fees depend on the annual test volume and number of laboratory specialties/subspecialties.

For further information on fees, please click here.

Can I have more than one CLIA number at the same location?

The CLIA regulations (42 CFR 493.35[a], 493.43[a], and 493.55[a]) generally require that all laboratories that perform waived and non-waived testing file a separate application for each laboratory location. Multiple laboratories may operate at the same physical location (e.g., same building or suite, as applicable) with separate CLIA numbers, as long as each laboratory can demonstrate that it is operating as a separate and distinct entity. Each CLIA certificate represents a laboratory, and each laboratory is responsible for complying with the applicable CLIA requirements.

Multiple laboratories that operate at the same physical location and use the same testing personnel and equipment must meet the following conditions:

1. All records (e.g., quality control, procedure manuals, and personnel competencies) must be kept separate and distinct for each laboratory and must clearly show that each laboratory is operating independently.
2. The hours of operation must be specified for each laboratory.
3. The hours of operation for each laboratory must be separate and distinct. The times of testing cannot overlap and cannot be simultaneous.