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Clinical Laboratory Federal & State Regulations

FDA Approved Waived & PPM Test Lists

  • Waived Test List  CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes (fda.gov) 
  • PPM Test List  Provider-performed Microscopy Procedures (cms.gov) 
  • FDA Approved OTC COVID-19 Antigen Test List https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/home-otc-covid-19-diagnostic-tests?utm_medium=email&utm_source=govdelivery 
  • Waived Tests CPT Code List  CLIA Waived Tests and CPT Codes 

CLIA Regulations

 Clinical Laboratory Federal laws & regulations About CLIA | CDC 

CLIA State Agency Phone & Email Contacts

The CDC maintains a list of state agency contracts that is accessible to anyone who wishes to apply for a clinical laboratory testing certificate or to find out additional information about testing. The list is located at   STATE SURVEY AGENCIES (CLIA CONTACT LIST) (cms.gov) 

State Specific Regulations & State Agency Websites

  • Alabama does not have any state specific regulations although they do have specific licensure application requirements at Facilities | Alabama Department of Public Health (ADPH) (alabamapublichealth.gov) and CLIA | Alabama Department of Public Health (ADPH) (alabamapublichealth.gov) 
  • Alaska does not have any state specific regulations. Their website for licensure application can be reached at https://health.alaska.gov/dph/Labs/Pages/clia/default.aspx
  • American Samoa does not have any state specific regulations or its own CLIA office. To file for a CLIA license for American Samoa, contact the San Francisco CMS office directly at CLIA_SanFrancisco_Office@cms.hhs.gov or 415-744-3696
  • Arizona does not have any state specific regulations. Their website for licensure application can be reached at ADHS - Laboratory Licensure & Certification - Clinical Laboratory Certification - Home (azdhs.gov) 
  • Arkansas does not have any state specific regulations that I could locate or a website.
  • California has a website for their Laboratory Field Services which manages the CLIA licensure application process and monitors federal & California state regulations, located at Clinical Laboratory Improvement Amendments (CLIA) The state specific regulations can be located at Regulatory Information - Laboratory Field Services (ca.gov) 
  • Colorado has a website for their CLIA Certification Program at Clinical Laboratory Improvement Amendments (CLIA) | Department of Public Health & Environment (colorado.gov) but does not have any state specific regulations.
  • Connecticut has a website for their CLIA Certification Program at Laboratory Quality Assurance Section but does not have any state specific regulations.
  • Delaware has a website for their CLIA Certification Program at CLIA: Clinical Laboratory Improvement Amendments - Delaware Health and Social Services - State of Delaware but does not have any state specific regulations.
  • District of Columbia (DC) has a website for their CLIA Certification Program at https://dchealth.dc.gov/page/health-regulation-and-licensing-administration but does not have any state specific regulations.
  • Florida has some state specific regulations regarding laboratory testing personnel although it rescinded the need for individual labs to have a state license. Now only the federal CLIA certificate is required for labs to operate in the state. More information can be found at their website AHCA: Laboratory and In-Home Services Unit (myflorida.com) 
  • Georgia has a website for their CLIA Certification Program at CLIA | Georgia Department of Community Health but does not have any state specific regulations.
  • Guam does not have a website for CLIA certification and are referred to the San Francisco office of CMS instead.
  • Hawaii has state specific licensure requirements both for testing personnel and for moderate and high complexity laboratories. For more information go to their website at Office of Health Care Assurance | Clinical Laboratories in Hawaii 
  • Idaho has a website for their CLIA Certification Program at Clinical Lab Certification | Idaho Department of Health and Welfare but does not have any state specific regulations.
  • Illinois doesn't have a CLIA program website but they do have state specific regulations for clinical labs that can be found at PART 450 ILLINOIS CLINICAL LABORATORIES CODE : Sections Listing (ilga.gov) 
  • Indiana has a website about CLIA at Health: Clinical Laboratory (CLIA) Licensing and Certification Program but does not have any state specific regulations.
  • Iowa has a CLIA laboratory program website at  Iowa CLIA Laboratory Program- State Hygienic Lab - The University of Iowa (uiowa.edu) although they do not have any state specific regulations.
  • Nevada regulations NAC: CHAPTER 652 - MEDICAL LABORATORIES (state.nv.us) licensure information Medical Laboratory Licensing (nv.gov) and application ALiS - Online Licensing System (aithent.com) 

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Sherwood Diagnostics

1-928-351-8800

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