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)
Judge Rules Against FTC In Westcliff Laboratory Case
IN A COURT RULING THAT WENT AGAINST the Federal Trade Commission (FTC) last week, Laboratory Corporation of America may have moved one step closer to completing its acquisition of Westcliff Medical Laboratories, Inc., of Santa Ana, California. On Fe…
$241 Million May Settle Quest Medi-Cal Claims
CEO SUMMARY: There’s movement in the negotiations between California state officials and Quest Diagnostics Incorporated over allegations that discounted lab test prices violated state law. In January, Quest disclosed that it had an “understanding” with California regulators…
Expect Changes in How Calif. Labs Set Test Prices
CEO SUMMARY: What a difference two years makes. Back in April 2009, when then-Attorney General Jerry Brown joined the whistleblower lawsuit alleging that seven or more California lab companies had violated state law on pricing provider services, the popular wisdom among lab execu…
Paper Requisition Signature Rule Contradicts 2001 Actions
CEO SUMMARY: Last year, the Centers for Medicare and Medicaid Services (CMS) used publication of the proposed 2011 Medicare Physician Fee Schedule to introduce new language that would require, as of January 1, 2011, that all paper requisitions for clinical laboratory tests for Me…
How Labs Should Comply With New Signature Rule
CEO SUMMARY: Across the nation, clinical laboratories and pathology groups are reacting to the new Medicare rule that requires a physician signature on a paper requisition for clinical laboratory tests. Laboratories using paper requisitions will need to add a signature line, then…
Discounted Lab Prices Become Issue in California
CEO SUMMARY: For decades, California’s lab testing market has been considered the Wild West because clinical lab companies have felt relatively free to offer deeply-discounted prices to expand market share and take business away from competitors. Now these discounted pricing pr…
Medi-Cal Gets Tough on Low Lab Test Prices
CEO SUMMARY: This may be the most significant lab industry story of 2010, which has gone unreported until now. Starting in June and July, California’s Department of Health Care Services determined that between 10 and 30 labs had submitted what the agency considers to be false c…
Who Wins and Who Loses With 51501 Enforcement
CEO SUMMARY: Assume that California’s Department of Health Care Services (DHCS) wins all challenges to enforcement of its interpretation of 51501(a). DHCS will get a one-time cash infusion as it collects money from labs which violated the state statute. But going forward, feder…
How Could So Many Labs Violate California Law?
CEO SUMMARY: If a 40-year-old state law on Medi-Cal pricing was known to regulators and clinical laboratories alike, how did the legal and compliance departments of so many laboratories—staffed by some of the smartest legal minds in California and nationally—interpret the law…
Calif. Officials Back Off From Suspending Labs
CEO SUMMARY: Early in the summer, California’s Department of Health Care Services (DHCS) delivered letters to between 10 and 30 laboratory companies notifying them that, effective immediately, it was withholding their Medi-Cal payments and was suspending each lab’s Medi-Cal l…
CURRENT ISSUE
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.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.