CEO SUMMARY: As a going business, Theranos may have been dissolved in September, but it continues to be in the news. The biggest development was a disclosure in federal court earlier this month by federal prosecutors that there may be additional criminal charges to come that go beyond the indictments of former CEO Elizabeth Holmes
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)
HOW OFTEN IS A DEFUNCT LAB COMPANY IN THE NEWS? That was the odd development last week when it was announced that a U.S. District Court had entered a $1.4 million civil judgement against Calloway Laboratories, Inc., a toxicology lab company formerly based in Woburn, Mass., for business practices during the period May 2014 through
IN RECENT DECADES, probably no sector of the U.S. healthcare system has seen the level of fraud and abuse that seems to pervade the clinical laboratory industry. The common perception is that illegal inducements between lab companies and referring physicians are rampant and federal prosecutors have failed to bring enough violators to justice to effectively
CEO SUMMARY: In a ruling issued Sept. 12, a U.S. District Court judge decided that two common clinical laboratory business practices are illegal inducements that can lead to charges of ling false claims. The practices occur when labs pay physicians to package and mail patients’ specimens and when labs waive copays and deductibles for patients.
HOW THE LAB OUTREACH BUSINESSES of rural hospitals originate lab specimens and bill for lab tests is getting increased scrutiny. The reason for this rise in interest is that a growing number of rural hospitals are generating almost as much revenue from laboratory outreach testing as they get from all other inpatient services.
Most rural hospitals
CEO SUMMARY: Federal criminal indictments were unsealed last Friday in San Francisco against Elizabeth Holmes and Ramesh “Sunny” Balwani for their actions as executives at Theranos, Inc., the once high-flying lab test company. Officials at the Department of Justice said the counts against Holmes and Balwani are based on the alleged actions of each to
CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the number of physicians who were worried about patient harm. After reviewing the concerns about
CEO SUMMARY: For medical directors and pathologists interested in improving their labs’ compliance with CLIA regulations, a report from federal and state inspectors of an inspection of the pathology lab at the Wake Forest Baptist Medical Center offers insights into what issues caught the inspectors’ attention. During their visit in February, the government lab inspectors
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
CEO SUMMARY: In response to information the pathology lab staff provided to the hospital’s risk manager last fall, and following a federal Centers for Medicare and Medicaid Services inspection in February, the Wake Forest Baptist Medical Center is taking corrective action to fix serious deficiencies in its anatomic pathology laboratory. In reports issued in February