The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

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Clinical Laboratory Improvement Amendments (CLIA)
Diagnostic testing helps health care providers screen for or monitor specific diseases or
conditions. It also helps assess patient health to make clinical decisions for patient care. The
Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require
clinical laboratories to be certificated by their state as well as the Center for Medicare and
Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic
tests they conduct.
Three federal agencies are responsible for CLIA:
The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center
for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
FDA
· Categorizes tests based on complexity
· Reviews requests for Waiver by Application
· Develops rules/guidance for CLIA complexity categorization

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CMS
· Issues laboratory certificates
· Collects user fees
· Conducts inspections and enforces regulatory compliance
· Approves private accreditation organizations for performing inspections, and approves
state exemptions
· Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
· Publishes CLIA rules and regulations
CDC
· Provides analysis, research, and technical assistance
· Develops technical standards and laboratory practice guidelines, including standards
and guidelines for cytology
· Conducts laboratory quality improvement studies
· Monitors proficiency testing practices
· Develops and distributes professional information and educational resources
· Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
All laboratory testing performed on humans with the exception of that conducted for research
is regulated by the CMS as designated by the Clinical Laboratory Improvement Amendments
(CLIA) of 1988. The CLIA require every “facility that tests human specimens for the purpose of
providing information for the diagnosis, prevention, or treatment of disease or impairment of,
or the assessment” of health to meet certain federal requirements.
If a pharmacy wishes to provide tests such as hemoglobin A1c or fasting lipid profiles, it is
considered a laboratory and must possess a CLIA certificate. Application materials may be
downloaded as a Portable Document Format, or PDF, file from the CLIA Web site or may be
requested by mail from the CLIA state survey agency. Materials provided include the
application form, instructions for completion, commonly performed waived tests, and
associated CPT codes.
Additional regulations exist in many states for CLIA-waived testing; therefore, individual state
agencies should be consulted for information concerning their requirements. Completed
applications should be mailed to the appropriate state agency and will be processed within 30

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days. Once obtained, the CLIA waiver must be displayed in the laboratory site designated as
the home base.
All reagents, test cassettes, and logbooks must be kept in this site and are subject to
inspection. Owing to a new initiative, 2% of CLIA-waived laboratories are subject to annual
inspection. Other inspections may be held to investigate complaints or to verify that only
waived tests are being performed. In addition to the CLIA-specific regulations, there may be
additional state or federal regulations that need to be followed, such as the Occupational
Safety and Health Administration regulations.
Although little has been published concerning pharmacists billing using a CLIA waiver, a PIN
can be assigned based on their CLIA number. The list of recognized provider or supplier types
found at the CMS Web site includes Independent Clinical Laboratory (CLIA). The CLIA
laboratories are directed to contact their Medicare carrier for a CMS-855B enrollment
application.
An imbedded hot link provides needed contact information for these carriers or can be
downloaded on the CMS Web page (www.cms.gov/forms/). A hard copy of the completed
form must be mailed to the Medicare carrier. At the same time, the state agencies must be
contacted for any additional forms and required information. Some state agencies will provide
assistance in Medicaid enrollment. Once the carrier has accepted the application and received
proof of the CLIA certificate, billings for laboratory services will be permitted.
Reference:
Clinical Laboratory Improvement Amendments (CLIA)