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ISDH Home > Health Care Quality & Regulatory > Acute Care/Hospitals > Clinical Laboratory (CLIA) Licensing and Certification Program > CLIA: Frequently Asked Questions CLIA: Frequently Asked Questions

State of Indiana/Indiana State Department of Health (ISDH) CLIA Program Frequently Asked Questions Updated: 5/1/2012

Who needs a CLIA certificate?

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//HowObtainCLIACertificate.pdf

Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. Medicare requires the CLIA certificate number before any claims can be processed. Certificates must be renewed every two years for as long as testing is being performed. Changes in ownership, location, and type of testing performed must be reported to the following agency within 30 days of the change.  Please see FORMS section for required forms. Completed forms can be scanned and e-mailed, faxed or mailed to:

FAX: 317-233-7157

E-mail: lswitzer@isdh.in.gov or rbridges@isdh.in.gov

Postal Mail:
Indiana State Department of Health
Attn: CLIA Program
2 North Meridian St, Rm 4A
Indianapolis, IN 46201

*** Do not send payment with your application****
It is the facility's responsibility to make sure that the level of testing performed matches the facility's certificate type. Reimbursements by Medicare may be denied if the test submitted does not match the certificate.

What certificate types are available?

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//TYPES_OF_CLIA_CERTIFICATES.pdf

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 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 health care 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.

What are the requirements for testing personnel?

Subpart M contains the personnel sections of the CLIA regulations [Sections 493.1351 through 493.1495]

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//apcsubm.pdf

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 after that.

There are no personnel requirements for waived testing.

To perform PPM testing under the PPM certificate you must be a licensed midlevel 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?

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/CLIA/03_Interpretive_Guidelines_for_Laboratories.asp#TopOfPage

The surveyor will schedule routine surveys within six months of the certificate expiration date. Complaints and revisit 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 effect 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.

Certificate of Waiver Project

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certificate_of_-Waiver_Laboratory_Project.html

To better encourage quality laboratory testing, in April 2002, CMS initiated on-site visits to approximately 2% of laboratories that have been issued a certificate of waiver (COW) under the Clinical Laboratory Improvement Amendment (CLIA). This was the first time that CMS has conducted educational visits in all 50 states, though two previous studies did include visits to a smaller number of states.

These visits are announced, information gathering and are designed to help educate the laboratories on sound laboratory practices.  The State agency surveyors will ensure that personnel conduct quality testing in a manner which protects patient safety, determine each laboratory's regulatory compliance, and make certain that each laboratory is only conducting the more simple tests that are appropriate for a certificate of waiver facility.  If problems are uncovered, the surveyors will provide education and assistance to the laboratories to help them achieve more accurate, reliable and timely test results.

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

Currently, the Indiana State Department of Health (ISDH) does not license laboratories or laboratory personnel. ISDH does have Communicable Disease and Universal Precautions rules that must be followed.  These rules can be found under Indiana Administrative Code 410 Article 1. Communicable Disease Control:

http://www.in.gov/legislative/iac/iac_title?iact=410

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

http://www.in.gov/boah/

http://www.in.gov/idem/

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

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

REF: S&C-10-12-CLIA

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.

Other sources of information are the Indiana Professional Licensing Agency (IPLA), Indiana Board of Pharmacy, and the Indiana Board of Nursing.

http://www.in.gov/pla/

http://www.in.gov/pla/pharmacy.htm

http://www.in.gov/pla/nursing.htm

Can patients order their own tests in Indiana?

https://www.cms.gov/CLIA/Downloads/directaccesstesting.pdf

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. Also, it is up to the laboratory to decide whether or not to provide Direct Access Testing.

How do I renew my CLIA Certificate?

Billing coupons are mailed from the U.S. Department of Health & Human Services, Baltimore, MD. Coupons for CLIA 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 2 weeks before your current certificate expires.

Compliance fee coupons for CLIA Certificate of Compliance renewals are mailed out twelve months prior to your current certificate expiration date. Full payment must be received before a compliance survey will be scheduled by ISDH. Once ISDH 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 my payment for my CLIA Certificate?

Make check payable to:
CLIA Laboratory Program

Mail check to:
CLIA Laboratory Program,
P.O. Box 530882,
Atlanta, GA 30353-0882

Write your CLIA identification number on the check, and include the billing coupon with your payment.
**Currently payment by internet or credit card is not available. ** 

When will I receive my new CLIA Certificate?

Renewed CLIA certificates will be mailed approximately two weeks prior to your current expiration date if full payment of CLIA fees is received. Initial CLIA certificates will be mailed approximately two weeks after full payment of CLIA fees is received.

How do I request changes for my CLIA Certificate?

A new CMS 116 CLIA Application may be completed for any changes.

A new CMS-116 CLIA Application, Enclosure I Methodology Test List and Enclosure A Ownership Documentation form, must be completed in their entirety and is required for:

  • All Initial Applications

A new CMS-116 CLIA Application and Enclosure A Ownership Documentation form, must be completed in their entirety and is required for:

  • Change of Ownership/ Tax ID

A new CMS-116 CLIA Application, completed in its entirety is required for:

  • All Certificate Status Changes (and an Enclosure I)
  • All Reactivations of CLIA Certificates
  • Laboratory Director Changes for non-waived testing
  • Multisite exception request (see page 2 of the application for types of exceptions) -  Not- for- profit limited health testing exception request require documentation showing not for profit status.

Written Notification, including the laboratory name, CLIA number, name of the laboratory director and/or owner, the changes being made and the signature of the Laboratory Director or his/her designee must be submitted for all other certificate changes including:

  • Facility Name
  • Facility Location
  • Facility Mailing Address
  • Ownership Information
  • Specialty/Subspecialty
  • Test Volume
  • Telephone and Fax Number
  • Accreditation Organization
  • Voluntary Closure/Termination
  • Personnel-Technical Supervisor
  • Director Changes for Certificates of Waiver

In lieu of written notification, a new CMS-116 application is also acceptable.
The back of the HHS/CMS Fee Coupon is acceptable for the following certificate changes only:

  • Facility Name
  • Facility Location
  • Facility Mailing Address
  • Telephone and Fax Number
  • Director Changes for Certificates of Waiver

     **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 ISDH within 30 days of the change. Requests to change your CLIA certificate type must be submitted on the CMS-116 CLIA Application for Certification BEFORE you perform any tests not covered under your current certificate. All change requests must be submitted to ISDH as follows:

FAX: 317-233-7157

E-mail: lswitzer@isdh.in.gov  or rbridges@isdh.in.gov

Postal Mail:
Indiana State Department of Health
Attn: CLIA Program
2 North Meridian St, Rm 4A
Indianapolis, IN 46201

When applying for a Provider Performed Microscopy Procedure (PPM) Certificate, Certificate of Compliance or Certificate of Accreditation, what additional information/documentation is required?

Documentation of laboratory director education and training:

Laboratory directors performing nonwaived 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, CMEs),
    • Credentials, and
    • Laboratory experience.

Individuals who attended foreign schools 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.

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 [Sections 493.1351 through 493.1495]

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/apcsubm.pdf

Certification Boards for High Complexity Laboratory Directors:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors.html
 
CME Credits for Moderately Complex Laboratory Directors:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CME_Courses_for_Laboratory_Directors_of_Moderate_Complexity_Laboratories.html

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 in writing to ISDH. Include 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. Submit requests to:

FAX: 317-233-7157

E-mail: lswitzer@isdh.in.gov or  rbridges@isdh.in.gov

Postal Mail:
Indiana State Department of Health
Attn: CLIA Program
2 North Meridian St, Rm 4A
Indianapolis, IN 46201

What is the cost for a CLIA certificate?

Certificate of Waiver: $150 for 2 year certificate

Certificate of Provider Performed Microscopy Procedures: $200 for 2 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, please see http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIA_certificate_fee_schedule.pdf

Forms

All forms (CMS 116 CLIA Application, Enclosure A Disclosure of Ownership and Enclosure I Methodology Test list) must be completed and signed and appropriate documentation attached for initial certificates and most changes of certificate type.

The CMS 116 CLIA Application and Enclosure A Disclosure of Ownership are completed for change of ownership and Tax ID. 

The CMS 116 CLIA Applications may be completed for any changes. 

CMS 116 CLIA Application: http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf

Enclosure A Disclosure of Ownership

Enclosure I Methodology Test List

Links

Proficiency Testing:
2011 CLIA Approved Proficiency Testing Providers: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//ptlist.pdf

Additional Information on Proficiency Testing:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure8.pdf

CLIA Brochure 2011:
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads//CLIABrochure.pdf

Calibration and Calibration Verification Procedures:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6065bk.pdf

Good Laboratory Practices for Waived Laboratories:
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//wgoodlab.pdf

How to obtain a CLIA certificate:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//HowObtainCLIACertificate.pdf

Laboratory Complaints:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//CLIAbrochure9.pdf

Laboratory Director Responsibilities:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//brochure7.pdf

Laboratory Director Qualifications:

Certification Boards for High Complexity Laboratory Directors:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors.html

CME Credits for Moderately Complex Laboratory Directors:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CME_Courses_for_Laboratory_Directors_of_Moderate_Complexity_Laboratories.html

Verification of Performance Specifications:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads//6064bk.pdf

OSHA Blood Borne Pathogens standards:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051