CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for
Laboratory ComplianceSkip to articles
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
- Staff review
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.
- Categorizes tests based on complexity
- Reviews requests for Waiver by Application
- Develops rules/guidance for CLIA complexity categorization
- 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
- 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)
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA.
The Diagnostic Accuracy and Innovation Act (DAIA) was made public
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number of labs that reported and the volume
IT WAS NATIONAL NEWS RECENTLY when Quest Diagnostics Incorporated disclosed a security breach involving the protected health information (PHI) of 34,000 individual customers.
This episode is a reminder to clinical labs and pathology groups of the need to guard protected health information. In fact, as part of its compliance with federal law, it was Quest Diagnostics
CEO SUMMARY: In the United States, medical labs have long recognized that paying over-market rates to lease phlebotomy space in physicians’ officers is an inducement and a violation of federal anti-kickback laws. In Australia, a law in 2010 that removed the cap on what labs could pay to lease phlebotomy space in physicians’ offices caused
STARTING JAN. 1, 2017, there are substantial penalties for labs that fail to properly meet the complex lab test price marketing reporting requirements of the Protecting Access to Medicare Act of 2014. Labs that fail to do so face the potential of stiff, multi-million dollar fines.
“Under PAMA, clinical labs need to report full and accurate
AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today.
“If you take the same patient sample and you send it to different labs, you can get different results,” stated Jeff Shuren, MD. He is
IN BROOKLYN, N.Y., a toxicology laboratory has been shut down temporarily since Sept. 9 by order of the New York State Department of Health. The lab was cited for failing to perform calibration and quality control procedures properly,
The lab company is Advanced Clinical Laboratory Solutions Inc., which describes itself as, “a physician-driven, patient-minded, client-focused clinical
CEO SUMMARY: Unlike federal prosecutors, who to date have shown little interest in seeking to recover money from either the physicians who accepted inducements from Health Diagnostic Laboratory or many of the shareholders, executives, and sales consultants of HDL, the trustee of the HDL bankruptcy is moving aggressively to attempt to collect money from all
IT IS CERTAINLY SIGNIFICANT NEWS FOR THE PATHOLOGY PROFESSION that a respected pathologist—indeed a pathology chair—is alleged to be involved in covering up a misdiagnosis of cancer for a patient who then had a healthy essential organ surgically removed.
And the story doesn’t end there. It is further alleged in court documents that, when a whistleblower