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)

Whistleblowers Disclose Issues in California’s COVID Lab

SUMMARY: Whistleblowers at the State of California’s brand-new COVID-19 Valencia Branch Laboratory are telling reporters about staff sleeping on the job, unlicensed staff handling specimens, and other significant issues. Given the reports of several news outlets, one relevant ques…

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Congress Passes Bill to Ban Surprise Medical Bills

Starting Jan. 1, 2022, out-of-network clinical laboratories may no longer be allowed to bill patients for lab tests performed in certain settings under a law both houses of Congress passed on Dec. 21.  The COVID relief bill includes a ban on unexpected m…

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New Federal Rule: Non-Physician Providers Can Supervise Testing

SUMMARY: It’s the latest example of how interim rules issued earlier this year in response to the pandemic are being made permanent by the federal Centers for Medicare and Medicaid Services. Issued on Dec. 2, this new final rule allows certain non-physician practitioners—includi…

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CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates

CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS).  The first letters were sent on Aug. 12 and le…

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Feds Revise Stark Law, Anti-Kickback Statute

CEO SUMMARY: It is essential that all clinical laboratories and anatomic pathology groups understand major changes in two new federal rules that take effect next month. Revisions to the Physician Self-Referral Law (also known as the Stark Law) and the Anti-Kickback Statue will have …

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New Twist: HHS Exerts Authority Over FDA on LDTs

CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…

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Medicare COVID Test Coding May Become a ‘Logistical Nightmare’

STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests.  The federal Centers for Med…

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CLIA Lab Inspections Different Because of COVID-19 Pandemic

WITH THE ONSET OF THE COVID-19 PANDEMIC IN MARCH, three of the major organizations deemed to have CLIA status suspended inspections of clinical laboratories for several months. Inspections and assessments of laboratories have restarted, but with significant changes because of the SARS-CoV-2 outbreak….

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DOJ $6B Fraud Crackdown Charges 345 Defendants

CEO SUMMARY: Department of Justice cases involving clinical labs or molecular test claims may represent about half (or about $3 billion) of the total fraudulent claims. Those claims stem from genetic testing, urine-drug and other tests, and healthcare services, the DOJ said. In additi…

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Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?

WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential downside—difficulty getting reimbursed for the test. On Aug. 19, the Department of Health and Human S…

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