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Laboratory Compliance

Laboratory compliance is the ongoing effort of clinical labs to meet certain standards of practice set by various government agencies. Most prominent of these are the Clinical Laboratory Improvement Amendments (CLIA), which establish Quality Assurance (QA) standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.

CLIA requires clinical laboratories to be certified 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.

Certification is also required to receive reimbursements from Medicare or Medicaid.

CLIA 88 requires Quality Assurance assessment of all labs for these QA standards:

  • Patient test management
  • Quality control
  • Proficiency testing
  • Test comparisons
  • Relate results to clinical data
  • Personnel
  • Communications
  • Complaints
  • Staff review
  • Records

These QA standards for laboratory compliance encompass a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of specimens tested. According to the CDC, good QA system achieves these four things:

  • Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation
  • Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs
  • Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified
  • Sustains high-quality employee performance

Three federal agencies are responsible for CLIA and laboratory compliance: 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

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)

Who’s For and Against FDA Draft LDT Rule?

CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual com…

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FDA & CMS Issue Letter, Agree on LDT Oversight

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

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Feds Bar Elizabeth Holmes from Government Health Programs

ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …

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Violating EKRA Earns Lab Owner an Eight-Year Prison Sentence

THIS MAY BE THE MOST HIGH-PROFILE CASE involving a clinical laboratory and the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Former Arrayit Corporation president Mark Schena was sentenced in October 2023 to eight years in federal prison and ordered to pay $24 million in resti…

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Healthcare Fraud Cases Include Decades-Long Cases of Deceit

Healthcare fraud cases continue to receive harsh penalties from the federal government as indicated in the case of a California clinical laboratory owner and her husband who attempted to defraud the government of millions of dollars. Lourdes Navarro and husband Imran Shams attempted to defraud ins…

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Proficiency Testing Ranks High as a CLIA Violation

CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…

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FDA Issues Proposed Rule to Further Regulate LDTs

CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…

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FDA’s Road to Regulation of Lab Developed Tests

CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…

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SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts

ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…

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How Private Payers Audit Labs for Possible Claims Fraud

EDITOR’S NOT…

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