CLIA Laboratory Standards: Requirements for Clinical Laboratory Compliance

Introduction to CLIA

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 establish quality standards for all laboratory testing performed on human specimens in the United States. CLIA certification is required for any facility performing testing for health assessment or diagnosis.

CLIA Program Overview

Regulatory Authority

• Centers for Medicare & Medicaid Services (CMS) administers CLIA
• FDA categorizes test complexity
• CDC provides technical and scientific support
• States may have additional requirements

Who Must Be Certified

• Hospital laboratories
• Reference laboratories
• Physician office laboratories
• Nursing home laboratories
• Pharmacies performing testing
• Health fairs (if testing done)
• Any site performing laboratory testing

Test Categorization

Certificate of Waiver (Waived Tests)

Simple tests with minimal risk of erroneous results:

• FDA-approved waived test systems
• Approved for home use
• Simple, accurate techniques
• Limited regulatory requirements

Common Waived Tests

• Dipstick urinalysis
• Fecal occult blood
• Urine pregnancy tests
• Blood glucose monitoring
• Certain rapid strep tests
• Some COVID-19 rapid tests

Moderate Complexity

• More complex than waived tests
• Requires trained personnel
• Quality control required
• Proficiency testing required

High Complexity

• Most sophisticated testing
• Highest personnel requirements
• Comprehensive quality systems required
• Examples: flow cytometry, molecular diagnostics

CLIA Certificate Types

Certificate of Waiver

• Only waived tests performed
• Follow manufacturer instructions
• Two-year validity
• Minimal regulatory requirements

Certificate of Provider-Performed Microscopy (PPM)

• Performed by physician, midlevel, or dentist
• During patient visit
• Specific microscopy procedures only
• Two-year validity

Certificate of Compliance

• Moderate and/or high complexity testing
• Surveyed by CMS or CMS agent
• Two-year validity

Certificate of Accreditation

• Moderate and/or high complexity testing
• Surveyed by approved accrediting organization
• CAP, Joint Commission, COLA, others
• Two-year validity

Certificate of Registration

Temporary certificate while applying for Certificate of Compliance or Accreditation.

Personnel Requirements

Laboratory Director

Responsible for overall operation, must meet qualifications based on test complexity:

• Physician (MD/DO) or doctoral scientist for high complexity
• Masters degree with experience for moderate complexity
• Responsible for ensuring quality of testing

Director Responsibilities

• Ensure policies and procedures established
• Employ qualified personnel
• Ensure quality assessment performed
• Ensure compliance with applicable regulations
• Sign and date test reports or delegate

Technical Consultant (Moderate Complexity)

• Provide consultation on technical matters
• Assist in establishing quality control program
• Evaluate staff competency

Clinical Consultant

• Available to provide clinical consultation
• Assist in correlating clinical and laboratory findings
• MD/DO or doctoral scientist

Technical Supervisor (High Complexity)

• Day-to-day supervision of testing
• Specific qualifications by specialty
• Responsible for technical problems

General Supervisor (High Complexity)

• Day-to-day supervision of testing
• On-site when high complexity testing performed

Testing Personnel

• Qualifications based on complexity
• High school diploma minimum for moderate complexity
• Associates degree or equivalent for high complexity
• Competency assessment required

Quality Systems

Quality Control

Requirements

• Establish and follow written QC procedures
• Include control materials of known values
• Frequency as specified or two levels per day of patient testing
• Document and review QC results
• Take corrective action for out-of-range results

Equivalent Quality Control (EQC)

Alternative approaches approved for some tests with specific documentation requirements.

Quality Assessment (QA)

• Ongoing monitoring of all testing phases
• Identify problems and take corrective action
• Document QA activities
• Review by laboratory director

Proficiency Testing (PT)

Requirements

• Enroll in approved PT program
• Test PT samples as routine patient samples
• Participate in all events
• Minimum 80% score for each analyte
• Maintain records for two years

Unsuccessful PT Performance

• Two consecutive or two of three failures: directed corrective action
• Continued failure may result in sanctions

Procedure Manual

Required Elements

• Requirements for patient preparation
• Specimen collection, handling, preservation
• Reagent preparation and storage
• Step-by-step test procedure
• Calibration procedures
• Quality control procedures
• Corrective action procedures
• Limitations of procedure
• Reference ranges
• Reporting results

Record Retention

Minimum Retention Periods

• Test requisitions: 2 years
• Quality control records: 2 years
• Proficiency testing records: 2 years
• Test reports: 2 years (10 years for pathology)
• Instrument maintenance: 2 years
• Personnel records: Duration of employment

Inspections and Enforcement

Survey Process

• Unannounced inspections
• Review of records and procedures
• Observation of testing
• Personnel interviews
• PT sample testing observation prohibited

Deficiencies

• Condition-level: Serious deficiency requiring correction
• Standard-level: Less serious, requires correction
• Plan of correction required for all deficiencies

Sanctions

• Directed plan of correction
• State monitoring
• Civil money penalties
• Suspension of Medicare/Medicaid payments
• Certificate revocation

Accreditation Organizations

Approved accrediting organizations with deemed status:

• College of American Pathologists (CAP)
• Joint Commission
• COLA
• American Association of Blood Banks (AABB)
• ASHI

Conclusion

CLIA compliance ensures laboratory testing quality and patient safety. Understanding certificate requirements, personnel qualifications, and quality systems is essential for clinical laboratory operations.