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)
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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