An Introduction to Laboratory Regulations: Part 1

Everyone who works in a laboratory knows that there are certain rules and regulations to be followed to ensure accuracy in testing, and the safety of both the patient and testing personnel. With all the acronyms floating around (CLIA, FDA, CAP, CMS, TJC) it can get confusing to keep track of who controls what, and which rules apply to your specific lab. In the first installment of this 3-part series on regulations, we’ll review the different federal agencies responsible for oversight and moderation of the laboratory. In part 2 we’ll go further in-depth to demystify testing complexity (waived, non-waived, PPM) and why it’s important to know the correct classification for the tests you perform. Lastly, we’ll review the optional accreditations available to labs, and how accreditation differs from certification.

CLIA

CLIA refers to the Clinical Laboratory Improvement Amendments of 1988. These amendments were drafted to the Public Health Services Act, in which the federal program was revised to include certification and oversight of clinical laboratory testing. Although there have been two additional amendments made after 1988 (1997, 2012), the law still continues to be cited as CLIA ’88 as it is named within legislation.

These CLIA regulations helped to establish quality standards for all U.S. laboratory testing performed on human specimens (except for research) for the purpose of assessment of health, or the diagnosis, prevention, or treatment of disease. The regulations cover all aspects of testing including general laboratory requirements, quality monitors, pre-analytics, analytic performance, post-analytics, and personnel requirements.

In addition to setting the basic ground rules for performing quality laboratory testing, the CLIA regulations also require clinical laboratories to be certified by their state as well as the Center for Medicare & Medicaid Services (CMS) before accepting human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they perform. In order for laboratories to receive payments from Medicare or Medicaid, laboratories must be properly certified for the testing they are performing and billing for.

There are 3 federal agencies responsible for enforcing the CLIA regulations: The Food & Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing.

CMS

The Centers for Medicare & Medicaid Services (CMS) is the federal agency responsible for ensuring that the CLIA standards are upheld and enforced. Their responsibilities include the following:

  • Issuing laboratory certificates
  • Collecting user fees
  • Conducting inspections and enforcing regulatory compliance
  • Approving private accreditation organizations (such as CAP) for performing inspections, and approves state exemptions
  • Monitoring laboratory performance on Proficiency Testing (PT) and approving PT programs
  • Publishing CLIA rules and regulations

FDA

The Food & Drug Administration (FDA) is primarily responsible for reviewing and approving new tests, instruments, and equipment used in diagnostic laboratories. They also perform the following tasks:

  • Categorize tests based on complexity
  • Review requests for Waiver by Application from manufacturers
  • Develop rules/guidance for CLIA complexity categorization

CDC

The Center for Disease Control and Prevention (CDC) responsibilities include the following tasks:

  • Provide analysis, research, and technical assistance
  • Develop technical standards and laboratory practice guidelines, including standards and guidelines for cytology
  • Conduct laboratory quality improvement studies
  • Monitor proficiency testing practices
  • Develop and distribute professional information and educational resources
  • Manage the Clinical Laboratory Improvement Advisory Committee (CLIAC)

To summarize, CLIA establishes the rules and guidelines that laboratories must follow to ensure they are providing accurate laboratory results. Federal agencies then work together to support the CLIA amendments and enforce compliance. All certified laboratories will be subject to inspection by regulatory agencies to ensure compliance with the rules. In some cases, your local state Department of Health (DOH) or accrediting agency may be more stringent or have additional requirements to be followed – always go with the stricter requirement to ensure compliance with all agencies.

Coming up next we’ll review how the FDA decides the complexity of each test, and how this designation will affect the CLIA rules to be followed.

References

  1. Electronic Code of Federal Regulations: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5
  2. Interpretive Guidelines for Laboratories: https://www.cms.gov/regulations-and-guidance/legislation/clia/interpretive_guidelines_for_laboratories.html

†


-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

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