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September 21, 2018

Clinical Laboratory Certification

Any Idaho laboratory performing tests on humans for the purpose of diagnosis, treatment, or assessment of health must have a license from the Centers for Medicare and Medicaid Services (CMS) as part of the Clinical Laboratory Improvement Amendment (CLIA) program. The CLIA regulations can be found at the CMS website. This license certifies a laboratory's ability to accurately determine lab test results.

IBL regulates over 1,000 clinical labs across the state, including hospitals, clinics, doctor's offices, and long-term care facilities. IBL's clinical lab inspector performs inspections for complex laboratories and monitors proficiency test events.

Labs beginning operation must complete and submit to the IBL Lab Improvement Section the following forms:

  • Director Appraisal Form:  Only needed for Certificate of Compliance or Certificate of Accreditation applications

Frequently Asked Questions for CLIA Certification

What is CLIA?
The objective of the federal Clinical Laboratory Improvement Amendments (CLIA) program is to ensure consistent, quality laboratory testing. CLIA established quality standards for laboratories to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test is performed.  CLIA regulations apply to laboratory testing in all settings, including commercial, hospital, and physician office laboratories on materials derived from the human body for the purpose of diagnosis, prevention, treatment, or the assessment of the health of human beings.  More information can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html.

Is our practice considered a laboratory?
The CLIA definition of a laboratory is any facility that performs testing on materials derived from the human body for the purpose of diagnosis, prevention, treatment, or the assessment of the health of human beings. If you perform any testing as defined by CLIA – even one, and even if you do not charge for the test – you are required to obtain a CLIA certificate. Research labs, forensic labs and labs that perform pre-employment drug testing are generally not subject to CLIA regulation. Please contact our office by phone (208)334-0528 or email LabImprovement@dhw.idaho.gov to discuss the testing you plan to perform. We can help determine if you need a CLIA certification or not.

What types of CLIA certificates are available?

Certificate of Waiver (CoW): A CoW certificate holder is allowed to perform only tests that are categorized by the FDA as waived tests. CLIA waived tests are considered as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Currently waived tests can be found on the following Food and Drug Administration (FDA) website: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

Certificate for Provider Performed Microscopy (PPM): A PPM certificate allows the holder to perform tests in which a microscopic examination is performed by a physician, mid-level practitioner, or dentist during a patient's visit – these tests are categorized as moderate complexity. A PPM certificate also allows the lab to perform waived tests.

Certificate of Compliance (CoC): A compliance certificate allows a laboratory to perform waived, as well as non-waived laboratory tests of either moderate and/or high-complexity. The test complexity is determined by the FDA.

Certificate of Accreditation (CoA): An accreditation certificate allows a laboratory to perform CLIA waived and non-waived (moderate and/or high complexity) testing. Inspections are conducted by the laboratory’s accrediting body. CMS-approved accrediting agencies include A2LA, AABB, AOA, ASHI, COLA, CAP, and TJC.  A list can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Accreditation_Organizations_and_Exempt_States.html.

Where can I find a list of CLIA Waived, PPM, and Non-Waived tests?
Lists of Waived, PPM, and Non-Waived, tests can be found at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Categorization_of_Tests.html.
 
How do I determine if a test is waived, PPM, moderate, or high-complexity?
The FDA website offers a great search feature found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA
/search.cfm
, or you may contact the vendor from whom you purchased the test for further information.

How do I get a CLIA certificate?
You must complete the federal form CMS-116 found on our website at www.statelab.idaho.gov, Clinical Lab Certification page. The CLIA form may be mailed to Lab Improvement, 2220 Old Penitentiary Road, Boise, Idaho 83712 emailed to LabImprovement@dhw.idaho.gov, or faxed to our office at (208) 334-4067.

Does the State of Idaho require a laboratory registration form, separate from CLIA?
No – the State of Idaho no longer requires laboratories to submit a separate form to register. Only the CMS-116 is required along with lab director credentials, if necessary.

Where can I find laws pertaining to laboratory testing in Idaho?
The Idaho law can be found on our website at www.statelab.idaho.gov on the Clinical Lab Certification page and Resources tab or at https://adminrules.idaho.gov/rules/current/16/160206.pdf.

What does the CLIA certification cost?
Federal CLIA fees are as follows:

  • Certificate of Waiver: $150 
  • Certificate of Provider Performed Microscopy: $200 
  • Certificate of Compliance or Certificate of Accreditation: Fees vary based on the annual test volume and number of laboratory specialties and subspecialties.

You can download a full CLIA laboratory fee schedule from https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International_Laboratories.html.

Each certificate is valid for two years. CMS will bill your facility beginning six months in advance of your renewal date.

We collect samples in our office and send them to a third-party, off-site laboratory. We do no point-of-care testing. Do we need a CLIA certificate?
No, if you are only collecting specimens and sending them off then you do not need a CLIA certificate. But be sure – CLIA covers every type of diagnostic test on materials derived from the human body.  If you do even one simple test at your facility, such as blood glucose or urine pregnancy test, your facility must be CLIA certified.

How long do I need to keep laboratory test results?
CLIA requires a retention time of 2 years for all lab tests.  These results must be kept in the lab area and include the data, quality control, and proficiency testing results related to the test in question. The permanent repository for all lab tests is the patient’s chart which has a five-year retention time requirement.

How do I make changes to my CLIA certificate?
You must notify the IBL Laboratory Improvement Section of changes in ownership, name, address, or director within 30 days of the change.  Changes in certificate type must be submitted to our office using the CMS-116 form and approved before you begin the new testing, unless you are transitioning from a higher level of testing to waived only. You will still need to submit the CMS-116 for the changes, but do not need prior approval to move to performing only waived testing.

Address/Name changes: 
You may complete the change form that is attached to your CLIA payment coupon or you may submit a Change of Information Form from our website. The form can be found by selecting the link or at www.statelab.idaho.gov under Clinical Lab Certification on the ’Existing Laboratories‘ tab. Be sure to include the pertinent changes and your CLIA ID number.

We will request a new CLIA certificate from CMS on your behalf for changes to the laboratory name, address or lab director, unless the date of the request is within six months of your current expiration date.  In that case, your current certificate will remain valid until your new CLIA certificate is issued by CMS.

Change of Certificate Type or Director:
To change your certificate type (e.g., changing from a Certificate of Waiver to a Certificate of Compliance) or your Laboratory Director, it is necessary to complete a new CLIA 116 form, signed by the Laboratory Director.

You will typically receive a bill from CMS approximately two weeks from the date the change of certificate type was processed. Once the bill is paid, CMS will issue a new CLIA certificate.

If you are changing your lab level from a CoW or PPM to a moderate- or high-complexity CoC or CoA, it is also necessary to submit the Director Appraisal form and the CV (curriculum vitae) of the prospective Laboratory Director.
 
I have specific questions about the CLIA regulations as they apply to the testing we are doing.  Who do I call?
Call the Laboratory Improvement Section at (208) 334-0528, or email LabImprovement@dhw.idaho.gov.

Who can order lab tests in Idaho?
All tests must be ordered by an ’authorized provider’ who, by definition in Idaho, is licensed to practice medicine in our state. This includes M.D.s, D.O.s, Physician Assistants, Nurse Practitioners, Pharmacists, Midwives and Chiropractors. Labs can honor written orders from out-of-state physicians and other categories of health providers, except for those not professionally licensed in the state of Idaho, such as Naturopaths and unlicensed Midwives.

My business provides drug testing for employment and/or forensic purposes. Do we need a CLIA certificate?
At this time, CLIA certification is NOT required to perform urine drug screens for employment or forensic purposes, since these screens do not go into a patient’s medical chart. Keep in mind, however, that if the result goes into a patient’s medical chart (i.e., for the purposes of behavioral health), CLIA certification is required.

We lost our CLIA certificate. Can we get a replacement?
We can typically request a duplicate CLIA certificate from CMS on your behalf, unless your certificate is less than six months from its expiration date. However, as long as your CLIA certification is current and in good standing, you may perform testing without the certificate on hand.  To request a duplicate certificate, please call (208)334-0528 or email our office at LabImprovement@dhw.idaho.gov.

I’m new to this position, and I’m not sure of our CLIA status, or how all of this works. How can I find out more?
Call the Laboratory Improvement Section at (208) 334-0528, or email LabImprovement@dhw.idaho.gov.  We will be happy to answer any questions you may have.

I just noticed our CLIA certificate has expired.  What do we do?
Don’t panic! Give us a call. We can look into your situation and advise you of the steps necessary to confirm and/or reinstate your certification.

I paid our CLIA bill weeks/months ago, but we haven’t yet received our certificate.
CMS begins billing six months before your certificate expires; however, new certificates are not mailed until approximately 30 days before your expiration date following payment of the certificate fee.

We are an out-of-state laboratory that performs clinical laboratory testing on specimens drawn from Idaho patients. Do we need to register our facility with the State of Idaho?
No.  If the testing is performed outside the state of Idaho, no state registration is required. You must have a valid active CLIA certificate in the state in which you are located. 

If a diagnosis is provided with the test results, it is required that the signing physician must be licensed to practice medicine in Idaho (per the Idaho Board of Medicine https://bom.idaho.gov/BOMPortal/BoardPage.aspx?Board=BOM).

What are the education, experience, and training requirements for Laboratory Directors?
There are very specific requirements mandated by CLIA for Laboratory Directors, which depend on the type of CLIA certificate and the level of testing.  For specific information, please contact our office, and we will be happy to assist you.

Is there laboratory personnel licensure in Idaho?
Idaho does not currently license laboratory personnel. CLIA, however, has set minimum standards for personnel, based on the type of CLIA certificate and level of testing.

  • Certificate of Provider Performed Microscopy: Individuals performing microscopic testing under a PPM Certificate must be a mid-level provider (e.g., PA, NP) or higher.
  • Certificate of Compliance (CoC) - Moderate Complexity: Individuals performing moderate-complexity testing under a CoC must have earned a high school diploma, and have undergone
    documented training.
  • Certificate of Compliance – High Complexity: Individuals performing high-complexity testing under a CoC must have earned at least a 2-year degree, and have undergone documented training.
  • Certificate of Accreditation: Please contact the accrediting agency directly for personnel requirements.

There are no minimum requirements for personnel conducting waived tests.

We are adding some tests to our lab testing menu.  Do we need to notify someone?
Notification is not necessary if you are adding tests within your certificate level.  You are required
to notify the Laboratory Improvement Section if you are increasing or decreasing the complexity of tests performed at your facility, or adding tests in a new specialty or subspecialty to your testing menu.  If you have any questions concerning the complexity of a specific test, you may search for it on the FDA website at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm or contact the vendor from whom you purchased/plan to purchase the test.

Will my laboratory be inspected? When and how often?
Certificate of Waiver (CoW) and Provider Performed Microscopy (PPM) laboratories are not routinely inspected.  However, all complaints are investigated regardless of certificate type, and laboratories are required to permit inspections. 

All Certificate of Compliance (CoC) laboratories are inspected once every two years; however, the initial inspection generally doesn’t occur until the lab has been in operation for at least 6 months.  Labs with a Certificate of Accreditation (CoA) will be inspected every two years by their accrediting agency.

Is there a checklist available for the inspection?
Please check our website in the Summer of 2018 for an interactive CLIA Regulations Checklist to assist your lab in meeting the CLIA requirements.  If you have specific questions regarding the inspection process, you may contact the IBL Clinical Laboratory Inspector at (208) 334-0528.

For further information regarding Certificate of Accreditation inspections, please contact the accrediting agency directly.

How do I file a complaint against a clinical laboratory?

You can file a complaint by calling the Laboratory Improvement Section at (208) 334-0528.  You can remain anonymous in reference to the complaint.  You can also view CLIA's Complaints brochure and find information on how to file a complaint with the Federal office of the Centers for Medicare and Medicaid Services.

CLIA Regulations on Proficiency Testing: Online Training Course:  This training will provide answers to a few common questions regarding proficiency testing requirements under CLIA.

Contact Information

Lab Improvement Section Manager: 
Amanda Bruesch

Address:  
Idaho Bureau of Laboratories
2220 Old Penitentiary Rd
Boise, ID 83712

Phone: (208) 334-0528

Fax: (208) 334-4067

E-mail:

labimprovement@dhw.idaho.gov