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Clinical Laboratory Improvement Amendments

Resources

Contact Information:

Francisca Leal Lehr, MS,MT(ASCP)
Cell:  206-498-1892
Office:  206-615-2710
Fax: 443-380-6168
francisca.lehr@cms.hhs.gov
 

Send mail to:

Alaska State Public Health Laboratory
Attn: CLIA Surveyor
5455 Dr. Martin Luther
King Jr. Ave.
Anchorage, AK  99507

Frequently Asked Questions about CLIA in Alaska

Our lab received a bill for their CLIA certificate and paid it by check. However, the lab has not received the new certificate and the current certificate is due to expire in 6 weeks? Is there anything I need to do?

  • For renewing certificates, CLIA sends a bill about six months prior to the expiration date.

    If the bill is paid, a new certificate is mailed to the laboratory about one month before the expiration date. If the lab has a copy of a canceled check and still does not receive their certificate 30 days prior the expiration date, contact Francisca Leal Lehr at (206) 615-2710 or e-mail francisca.lehr@cms.hhs.gov.

    I work in a physicians’ office laboratory that has a Provider Performed Microscopy Procedures (PPMP) certificate. The licensed physicians and mid-level providers do wet mounts and urine microscopic examinations. I am an Alaska state licensed registered nurse (RN) and hold a bachelor’s degree in nursing. Can I perform the same microscopic procedures as the physicians and mid-level practitioners under this PPMP certificate?

    • A licensed nurse would not be qualified to perform microscopic procedures under the PPMP certificate. A nurse could do this testing only in a moderate or high complexity laboratory with a Certificate of Compliance or Certificate of Accreditation. An RN would be limited to waived testing.
    • Licensed mid-level practitioners such an MD, DO, DPM, Dentist, or a licensed physician assistant, nurse practitioner or nurse midwife would be qualified as laboratory directors or testing persons with the PPMP certificate.

    Is there a way to find out which tests are on the CLIA waived list? Also what are the waived CPT codes for billing Medicare and Medicaid?

    • Once you are at this website, scroll down the left-hand column of topics until you see “Categorization of Tests”. Click on that and you will see Downloads at the bottom of the page. One of the downloads is ‘List of Waived Tests”. There is also a “List of PPMP”. You can download them to your computer or print them from the website.
    • The best way to find out which tests have been categorized as waived by the FDA is to go online to the CLIA website. The address is: http://www.cms.hhs.gov/clia/

    I am a licensed naturopath in the State of Alaska. Would I be qualified to perform wet mounts and urine microscopic procedures under a PPMP certificate?

    • Only Alaska licensed providers such as MD, DO, DPM, Dentist, or a licensed physician assistant, nurse practioner or nurse midwife would be qualified.
    • A naturopath would be limited to performing waived testing only.

    What am I agreeing to when I apply for a Certificate of Waiver? Are there any personnel regulations with the waived certificate?

    • There are no personnel requirements for the Certificate of Waiver.
    • When you hold a certificate of waiver, you are agreeing to perform only those tests on the CLIA waived list. Check on the CLIA website to be sure your test (with the appropriate specimen) is on the waived list.
    • You are also agreeing to follow the manufacturer’s instructions. Be sure to read the manufacturer’s instructions carefully and use the most recent package insert.

    I work for a physician who wants to add a new kit to detect Group A Streptococcus from throat swabs. Where do I check to see if this kit is waived or moderate complexity?

    • The CLIA website has a list of all the waived tests.
    • If you don’t find the kit on the waived list by name of test or manufacturer, then it is not a waived test.
    • You can also go online to the FDA website. This website will allow you search under the Test System/Manufacturer or the Analyte Name. It will provide the test category and the specimen type that can be used for that category.

    How much does a CLIA certificate cost and how often do they have to be renewed?

    • CLIA certificates vary in price depending on the level of testing. A Certificate of Waiver costs $150.00 for two years. A Certificate for Provider Performed Microscopy Procedures costs $200.00.
    • Compliance (inspection) fees for Certificate of Compliance or Certificate of Accreditation vary depending on the laboratory’s annual test volume. They range from $300 for less than 2,000 tests per year to $2226 for over 1,000,000 tests per year.

    What is a multiple-site CLIA certificate? Does our laboratory qualify for one?

    • There are three ways to qualify for a multiple site certificate:
    • The laboratory has temporary testing sites
    • The laboratory is not-for-profit or Federal, State or local government engaged in limited public health testing (not more than 15 moderate complexity or waived tests per certificate).
    • The laboratory is at a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location and under common direction.
    • Please visit Eligibility for a Multiple-Site Laboratory for additional infromation.