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Laboratory Regulations Questions and Answers
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Laboratory Regulations Questions and Answers Clinical Laboratory Improvements Amendments (CLIA) - a Public Law passed in 1988 that establishes quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results - every site testing materials deriv...

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  • December 29, 2024
  • 6
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • laboratory regulations questions and answers
  • centers for medicare and medicaid services cms
  • food and drug administration fda categorizes tes

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  • Laboratory management
  • Laboratory management

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Laboratory Regulations Questions and
Answers
Clinical Laboratory Improvements Amendments (CLIA) - answer - a Public Law
passed in 1988 that establishes quality standards for all laboratory testing to ensure
accuracy, reliability, and timeliness of patient test results
- every site testing materials derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any disease is subject to the
law

Centers for Medicare and Medicaid Services (CMS) - answer - an organization that
is responsible for registering laboratories for CLIA certificates, collecting fees, on-site
and self-inspection surveys, surveyor guidelines and training (for enforcement actions
when needed), approving proficiency testing providers, accrediting professional
organizations, and exempting states

Food and Drug Administration (FDA) - answer categorizes test methods for
complexity; waived, moderate complexity, and high complexity

Waiver Certificate - answer - a CLIA certificate that permits a site to perform only
those tests methods identified as waived

Provider-Performed Microscopy Procedures (PPMP) Certificate - answer - a CLIA
certificate issued to a laboratory for physicians, midlevel practitioners, or dentists to
perform PPMP procedures, or those tests on specimens collecting during a physical
examination along with waived tests

Registration Certificate - answer - a CLIA temporary certificate issued to enable
laboratories to conduct waived, moderate, and/or high complexity laboratory testing
while waiting to be inspected and issued a certificate of compliance

Compliance Certificate - answer - a CLIA permanent certificate issued to inspected
and approved labs to conduct waived, moderate, and/or high complexity laboratory
testing
- inspections by an agent of CMS

Accreditation Certificate - answer - a CLIA certificate issued to laboratories seeking
accreditation by a CMS-deemed professional organization
- are approved to conduct waived, moderate, and/or high complexity laboratory testing
- laboratories must pay both the professional organization and CLIA fees
- are inspected every two years by the professional organization
- CMS still has the right to a quality check re-inspect to up to 5% of testing sites
accredited by deemed organizations

, Waived Testing - answer Status may be granted to:
1) any test listen in the regulation,
2) any test system in which the manufacturer provides scientifically valid data to meet
the waiver criteria, and
3) test systems cleared by the FDA for home use
- use such simple and accurate methodologies that the likelihood of erroneous results is
negligible
- CMS inspectors responsible for determining adherence to CLIA regulations will not
inspect waived testing facilities unless a specific complaint has been lodged or
fraudulent activities are suspected

Moderate Complexity Testing - answer -Each lab test system/methodology graded
for level of complexity 1-3 (ascending complexity) on:
1) Knowledge
2) training and experience
3) reagents and materials preparation
4) characteristics of operational steps
5) calibration, QC, and PT materials
6) test system troubleshooting and equipment
7) interpretation and judgement

-test systems receiving a total score of 8-12

High Complexity Testing - answer -Each lab test system/methodology graded for
level of complexity 1-3 (ascending complexity) on:
1) Knowledge
2) training and experience
3) reagents and materials preparation
4) characteristics of operational steps
5) calibration, QC, and PT materials
6) test system troubleshooting and equipment
7) interpretation and judgement

-test systems receiving a total score of 13+

Director - answer - necessary position for sites performing moderate complexity
testing
- can range from a physician to someone with a bachelor's degree in medical
technology/CLS or a degree in chemical, physical, or biological science and having two
years of lab training/experience and two years of lab supervisory experience
- responsible for all aspects of lab operation and administration
- responsible for ensuring that all duties are properly performed
- when director is a physician, typically also serves as the clinical consultant

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