Clinical Lab Governance & Regulation

Lecture 11

HIPAA

Protects patient information/privacy

OSHA

Protects the employee (safety)

False Claims Act

Punishes people who submit false medical claims to federal health programs

Anti-Kickback Statute and Stark Laws

There can be no financial incentive in exchange for referrals- also may penalize labs for offering discounted prices in certain cases

CLIA ‘88

• U.S. federal regulatory standards that govern all clinical laboratories testing human specimens for health assessment, diagnosis, prevention, or treatment

• sets quality stands for:

  • proficiency testing, patient test management, quality control, personnel qualifications, quality assurance

Waived Testing

• simple test with a low risk for an incorrect result

  • CLIA regulations list some waived tests

  • any test FDA cleared for at-home use is considered waived

  • manufacturers can apply to FDA for waived status- must provide scientific evidence that method fits waived criteria

Point of Care Testing (POCT)

• testing provided at site of patient care treatment

• rapid result TAT

• little training required for testing personal

Non-waived Testing

• the term used to refer collectively to moderate and high complexity testing

• laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards for this level of complexity

• standards include lab oversight, testing personnel qualifications, proficiency testing etc.

Centers for Medicare and Medicaid Services (CMS)

utilizes a quality assurance focus combined with an educational approach to assess and ensure compliance

CLIA Approved Inspectors

• AABB - Association for the Advancement of Blood and Biotherapies

• CAP - College of American Pathologists

• COLA - Commission on Office Laboratory Accreditation

• TJC - The Joint Commission (formerly JCAHO)

Clinical Laboratory Standards Institute (CLSI)

a peer professional group that develops standardized criteria regarding laboratory practices; accrediting and licensing entities often adopt these standards (formerly NCCLS)

Centers for Disease Control and Prevention (CDC)

• federal agency under US Department of Health and Human Services (HHS)

• publishes Morbidity and Mortality Weekly Report

  • discusses blood-borne pathogens and infectious waste disposal recommendations, etc.

• guidelines published by the CDC often are incorporated into OSHA

Food and Drug Administration (FDA)

• classifies test according to potential public health risk

• FDA inspects blood donor and/or component manufacturing facilities irrespective of other regulatory agencies and/or accrediting organizations

Other Regulatory Agencies

• EEOC - Equal Employment Opportunity Commission

• DOT - Department of Transportation and International Air Transport Association

• ADA - Americans with Disabilities Act

Other Laboratory Organizations

• ASCLS - American Society for Clinical Laboratory Science

• ASCP - American Society for Clinical Pathology

• ADLM - Association for Diagnostics & Laboratory Medicine

• ASM - American Society for Microbiology

• AABB - American Association for Blood Bankers