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)
Healthcare Fraud Cases Include Decades-Long Cases of Deceit
By Robert Michel | From the Volume XXX, Number 16 – November 13, 2023 Issue
Healthcare fraud cases continue to receive harsh penalties from the federal government as indicated in the case of a California clinical laboratory owner and her husband who attempted to defraud the government of millions of dollars. Lourdes Navarro and husband Imran Shams attempted to defraud ins…
Proficiency Testing Ranks High as a CLIA Violation
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
FDA Issues Proposed Rule to Further Regulate LDTs
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
FDA’s Road to Regulation of Lab Developed Tests
By Robert Michel | From the Volume XXX, No. 14 – October 2, 2023 Issue
CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…
SALSA Bill Resurfaces, Poised to Reduce Upcoming PAMA Cuts
By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue
ANOTHER ROUND OF STIFF PRICE CUTS TO THE MEDICARE PART B CLINICAL LABORATORY FEE SCHEDULE (CLFS) is just months away, with the provisions of the Protecting Access to Medicare Act (PAMA) set to resume on Jan. 1. In…
How Private Payers Audit Labs for Possible Claims Fraud
By Virchow | From the Volume XXX, No. 14 – October 2, 2023 Issue
EDITOR’S NOT…
No Surprises Act Sparks a Slew of Court Decisions
By Scott Wallask | From the Volume XXX, No. 13 – September 11, 2023 Issue
CEO SUMMARY: Multiple lawsuits filed by the Texas Medical Association against the federal government have resulted in key decisions that affect provisions in the law. Qualifying payment amounts and …
Private Health Insurers Are Aware of Problems with CPT Code 81408
By Virchow | From the Volume XXX, No. 13 – September 11, 2023 Issue
EDITOR’S NO…
OIG: Billing Code 81408 Is at ‘Risk of Improper Payment’
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
CEO SUMMARY: Clinical lab executives familiar with molecular test coding and billing will not be surprised to learn that billing code 81408—commonly used on genetic test claims—is at risk of fra…
Competency Assessments Prove To Be a Nagging CLIA Deficiency
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…
CURRENT ISSUE

Volume XXX, Number 16 – November 13, 2023
In this issue, Clinisys CEO Michael Simpson explains new developments in digital technologies that will expand the value and role of lab test data. Also, recent cases of healthcare fraud are examined, and whole genome sequencing for newborns is shown to be gaining favor with physicians and payers alike.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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